Cobas® 8000 Modular Analyzer Series: Complete User Documentation - Version 5.7 Software Version 06-09

cobas® 8000 modular analyzer
series
Complete User Documentation – Version 5.7
Software Version 06-09
(01)07613336217375(8012)06-09
2
Publication information
Publication version Software version Revision date Change description

1.0 01–01 2009-06 First version
2.0 02–01 2010-01 e 602 module added
3.0 03–01 2010-10 c 702 module added
4.0 04–01 2013-04 General update including, by way of example:
o New software features such as review of calibrator
status, PT link, rack unloading, change rack priority,
reagent cassette masking
o Revised software features such as download of
applications, calibrators, and QC material
o Hitergent was replaced by EcoTergent
4.0.1 04–01 2013-05 Manual cleaning revised
4.0.2 04–01 2013-06 Cleaning of pipetter probes revised
4.1 04–02 2013-11 o Changed ISE measuring ranges
o Use of different sample tubes on a rack
o Other changes and corrections
4.2 05–01 2014-10 New software features added
u What is new in publication version 4.2? (30)
5.0 06–02 2016-05 Publication redesigned according to the new Roche
documentation concept.
e 801 module added.
5.1 06–03 2016-10 o Inclusion of information on the ISE support box
o Inclusion of the addendum "Cleaning rack trays"
o New section about fluorinated greenhouse gas
o Updated cobas link information
o Minor changes throughout the document
5.2 06–05 2017-12 o Inclusion of the addendum "Sample foam
detection"
o Inclusion of the addendum 1.0 to Operator’s
Manual version 5.1 (specifications of radio
equipment)
5.3 06–06 2018-12 o Inclusion of the addendum 1.0 to Operator's
Manual version 5.2 (instrument approvals)
o Inclusion of the addendum 1.0 to Safety Guide
version 5.2 (cyber security)
o Inclusion of information on extended power off for
2 to 17 days procedure
5.4 06–07 2019-10 o Warning message in Safety guide added about
sharps, rough edges, and/or moving parts
y Revision history
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-09 · Complete User Documentation · 5.7
3
Publication version Software version Revision date Change description

5.5 06–08 2020-11 Version 5.5 is an intermediate version that has not been
published separately, but only together with
publication version 5.6. This intermediate version
includes:
o Changes and additions implemented
o Interlock Manual V2.1 integrated
5.6 06–08 2021-05 o IVDR update
5.7 06–09 2022-09 o Addendum 1.0 of version 5.6 implemented
y Revision history
Edition notice This publication is intended for users of the cobas® 8000
modular analyzer series.
The cobas® 8000 modular analyzer series is composed of

2 main components:
• The instrument includes the analytical modules, the
control unit, and other core components.
• The cobas® 8000 data manager consists of a PC which
coordinates data in real time between the instrument
and the host.
Every effort has been made to ensure that all the

information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information as
output of product surveillance activities, leading to a new
version of this publication.
Where to find information The Online Help contains all information about the product,
including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Software reference
• Configuration information
• Background information
The Safety Guide contains important safety information.

You must read the Safety Guide before operating the
instrument.
The Operator’s Manual focuses on routine operation and

maintenance. The content is organized according to the
normal operation workflow.
Roche Diagnostics
4
The Quick Reference Guide provides you with an overview

of pre-routine and routine tasks on the data manager and
instrument.
cobas® e-library provides access to important updates,

Method Sheets, Value Sheets, and other important
documents from Roche.
A separate Operator’s Manual is available for the

cobas® 8000 data manager.
The PC manufacturer’s manual contains all information

about the control unit hardware.
The original version of this document is in English. All

translations of this document have been translated from
the original version in English. You can find the original and
translated versions of this document at: dialog.roche.com.
Contact your local affiliate or Roche Service

representative for more information.
cobas® 8000 modular analyzer series can be used with all

released tests. Tests approved for use on the instrument
are available under eLabDoc on the Roche DiaLog website:
dialog.roche.com.
! General attention
To avoid serious or fatal injury, ensure that you are familiar
with the system and safety information before you use the
system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not described
in this publication.
r Store all publications in a safe and easily accessible
place.
! Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents which
may occur when using this product.
Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche Diagnostics.
Leave tasks that are not described in the user
documentation to trained Roche Service representatives.
Images The images in this publication have been added exclusively

for illustration purposes. Configurable and variable data in
screenshots, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
Roche Diagnostics
5
Warranty Any customer modification to the system renders the

warranty or service agreement null and void.
For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service

representative, or perform such updates with their
assistance.
Copyright © 2007–2022, Roche Diagnostics GmbH.

All rights reserved.
License information cobas® 8000 modular analyzer series software is

protected by contract law, copyright law, and international
treaties. cobas® 8000 modular analyzer series contains a
user license between F. Hoffmann-La Roche Ltd. and a
license holder, and only authorized users may access the
software and use it. Unauthorized use and distribution may
result in civil and criminal penalties.
License agreement for UltraVNC software UltraVNC and Linux Kernel are pieces of free software for
and Linux Kernel all commercial uses, which are installed on the control unit
PC.
You can redistribute the software and/or modify it under

the terms of the GNU General Public License (version 2 or
later), as published by the Free Software Foundation. A
copy of the GNU General Public License (version 2) is
stored on the control unit PC. The path for the license is
C:\Program Files\uvnc bvba\UltraVNC.
The software is distributed without warranty. There is no

implied warranty of merchantability or fitness for a
particular purpose. For more information, see the GNU
General Public License at http://www.gnu.org/licenses.
The source code for the software is stored on the control

unit PC. The path for the source code is
C:\DriversAndTools\UltraVNC.
Roche Diagnostics
6
Open Source and Commercial Software cobas® 8000 modular analyzer series may include
components or modules of commercial or open-source
software. For further information on the intellectual
property and other warnings, as well as licenses pertaining
to the software programs included in cobas® 8000 modular
analyzer series, refer to the electronic distribution
included with this product.
This open source and commercial software and

cobas® 8000 modular analyzer series as a whole can
constitute a device regulated in accordance with
applicable law. For more detailed information, refer to the
user documentation and labeling.
Note that the respective authorization is no longer valid

according to the corresponding legislation should any
unauthorized changes be made to cobas® 8000 modular
analyzer series.
CPS Security API Copyright © 2017 F. Hoffmann-La Roche Ltd.

All rights reserved.
The CPS Security API is protected by contract law,

copyright laws, and international treaties.
The CPS Security API is licensed for use between

F. Hoffmann-La Roche Ltd and a licensee, and only users
authorized there under are permitted to access and use
the software. Unauthorized use and distribution may result
in civil and criminal penalties.
Other product names and trademarks are the property of

their respective owners.
CPS Security API might contain components or modules

that are Open Source or Commercial Software programs.
For copyright and other notices and licensing information
regarding such Software programs included with CPS
Security API please see the following license notifications
and licenses.
The product and the CPS Security API as a whole may form
a regulated device in accordance with the applicable laws
– please refer to the User Guide and the labeling for
details. Please note that the respective authorization in
accordance with the applicable laws lapse in case of any
unauthorized changes to the CPS Security API.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS E, COBAS INTEGRA, and LIFE

NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective

owners.
Roche Diagnostics
7
Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of this
publication is welcome and is considered during updates.
Contact your Roche representative, should you have any
such feedback.
Approvals The cobas® 8000 modular analyzer series complies with

the following directives and regulations:
Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical
devices.
Regulation (EU) 2017/746 of the European Parliament and

of the Council of 5 April 2017 on in vitro diagnostic medical
devices and repealing Directive 98/79/EC and Commission
Decision 2010/227/EU.
Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.
Directive (EU) 2015/863 of 31 March 2015 amending

Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of
restricted substances.
Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making available
on the market of radio equipment and repealing Directive
1999/5/EC.
Regulation (EU) No 517/2014 of the European Parliament

and of the Council of 16 April 2014 on fluorinated
greenhouse gases and repealing Regulation (EC) No
842/2006.
Compliance of specific instruments with the respective

directives or regulations is provided by means of the
Declarations of Conformity where applicable.
Check the serial number of the instruments to identify the

applicable directives and/or regulations.
Fluorinated greenhouse gases specifications can be found

in supporting information identified by serial number of the
instruments.
All documents are available under eLabDoc on the Roche

DiaLog website: dialog.roche.com.
If you are unable to access Roche DiaLog, contact your

Roche Service representative.
Roche Diagnostics
8
Compliance is provided by means of the Declaration of

Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU

regulations.
Issued by Intertek for Canada and the US.
Instrument approvals Furthermore, the instrument is manufactured and tested

according to the following international safety standards:
• IEC 61010-1
• IEC 61010-2-101
The instrument complies with the emission and immunity

requirements described in standard IEC 61326-2-6/
EN 61326-2-6.
Roche Diagnostics
9
Contact addresses
Inside the European Union and

EFTA member states
Manufacturer of the Hitachi High-Tech Corporation

instrument 1-17-1 Toranomon, Minato-ku,
Tokyo, 105-6409
Japan
Authorized Roche Diagnostics GmbH

representative and Sandhofer Strasse 116
Importer 68305 Mannheim
Germany
Outside the European Union and

EFTA member states
Manufactured by: Hitachi High-Tech Corporation
Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Distributed in USA by: Roche Diagnostics

9115 Hague Road
Indianapolis, Indiana
USA
For cobas® 8000 data manager worldwide
Manufacturer of Roche Diagnostics GmbH

cobas® 8000 data Sandhofer Strasse 116
manager 68305 Mannheim
Germany
Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm
eLabDoc Electronic user documentation can be downloaded under

eLabDoc on the Roche DiaLog website: dialog.roche.com.
For more information, contact your local affiliate or Roche

Service representative.
Roche Diagnostics
10
Roche Diagnostics
Table of contents 11
Table of contents
Publication information 2 5 Reagents

Contact addresses 9 About reagent statuses 307
Table of contents 11 Defining the reagent warning levels 310
Intended use 17 Working with reagent masking 312
Symbols and abbreviations 18 Reagents of the ISE module 316
What is new in publication version 5.7? 23 Reagents of the c 701 module 326
What is new in publication version 5.4? 27 Reagents and consumables of the e 801
What is new in publication version 5.3? 27 module 390
What is new in publication version 5.2? 28 Reagents and consumables on the e 602
What is new in publication version 5.1? 28 module 440
What is new in publication version 5.0? 29
What is new in publication version 4.2? 30 6 Calibration
Calibration 465
Calibrating tests on the ISE and cobas c
Operation modules 498
Calibrating tests on the cobas e modules 502
1 Safety guide
Safety classifications 37 7 Quality control
Safety precautions 38 About quality control (QC) 513
Warning messages 46 About QC types 515
Caution messages 56 About automated third-party QC materials 517
Notices 59 Performing routine QC 519
Product safety labels 61 Performing QC for standby reagents 521
Safety information for barcode readers 94 Performing timeout QC 523
Safety interlock 97 Performing QC after calibration 525
Safety information for disposal 101 Performing manual QC 527
Checking QC results 529
2 Overview of the system Installing QC material data from the data
About the system 105 manager 531
About the data manager 108 Deactivating tests for QC material 534
About the control unit 109 Assigning non-barcoded QC material to rack
About the core components 111 positions 535
About the cobas® ISE module 121 Unloading auto QC racks from the auto QC
About the cobas c 701 module 134 compartment 537
About the cobas c 702 module 149
About the cobas c 502 module 168 8 Orders and results
About the cobas e 801 module 184 About sample processing 541
About the cobas e 602 module 205 About data distribution 542
About barcode and non-barcode mode 544
3 Overview of operation Switching between barcode and non-barcode
Overview of the user interface 223 mode 546
Using the help system 240 About the Rack Reception mode 548
Overview of cobas® link 246 Ordering tests 550
Working with barcodes 559
4 Before operation Loading samples 562
Quick reference: Main workflow 257 Processing samples 574
Starting the instrument 261 Working with sample results 581
Troubleshooting system alarms 284 Processing rerun tests 595
Preparing the instrument for operation 285 Unloading samples manually 600
Measuring samples 299 About the Calibration Review submenu 601
Roche Diagnostics
12 Table of contents
9 After operation 14 Maintenance of the ISE module

Performing manual finalization on cobas e List of maintenance actions on the ISE
modules 607 module 841
Performing data backup and archiving 610 Daily maintenance of the ISE module 843
Preparing the instrument for powering off 622 Weekly maintenance of the ISE module 852
Powering off the instrument 623 Monthly maintenance of the ISE module 855
Every 2 months maintenance of the ISE
10 Special operation module 862
Overview of masking functions 639 Quarterly maintenance of the ISE module 868
Operating with a pre-analytical system 641 Every 6 months maintenance of the ISE
Operating the instrument in backup operating module 874
mode 644 Maintenance as required on the ISE module 878
11 Configuration 15 Maintenance of the c 701 and c 702 modules

Overview of configuration 655 List of maintenance actions on the c 701 and
Setting the time switch 656 c 702 modules 897
Defining system settings 667 Daily maintenance of the c 701 and c 702
Installing applications 704 modules 899
Defining application settings 731 Weekly maintenance of the c 701 and c 702
Defining special wash data 751 modules 907
Assigning tests to modules 762 Monthly maintenance of the c 701 and c 702
modules 919
Quarterly maintenance of the c 701 and c 702
Maintenance modules 936
Every 6 months maintenance of the c 701 and
12 Overview of maintenance c 702 modules 941
Maintenance definitions 771 Maintenance as required on the c 701 and c 702
About performing maintenance 773 modules 947
About modes for maintenance 774
About maintenance pipes and maintenance pipe 16 Maintenance of the c 502 module
functions 786 List of maintenance actions on the c 502
Creating a maintenance type 795 module 975
Checking maintenance due time 798 Daily maintenance of the c 502 module 977
Checking maintenance status 799 Weekly maintenance of the c 502 module 984
Requesting a maintenance report 800 Monthly maintenance of the c 502 module 991
List of maintenance actions 802 Quarterly maintenance of the c 502
List of maintenance checks 807 module 1009
List of maintenance schedules for all Every 6 months maintenance of the c 502
modules 811 module 1013
List of cleaning solutions 815 Maintenance as required on the c 502
List of spare parts and replacement module 1019
intervals 816 Maintenance as required on the c 502 module
List of maintenance videos 818 (with interlock release tool) 1027
13 Maintenance of the core unit and the MSBs 17 Maintenance of the e 801 module
List of maintenance actions on the core unit and List of maintenance actions on the e 801
the MSBs 823 module 1051
Daily maintenance of the core unit and the Daily maintenance of the e 801 module 1053
MSBs 824 Every 2 weeks maintenance of the e 801
Monthly maintenance of the core unit and the module 1058
MSBs 826 Maintenance as required on the e 801
Maintenance as required on the core unit and the module 1080
MSBs 832
Roche Diagnostics
18 Maintenance of the e 602 module Software description

List of maintenance actions on the e 602
module 1105
21 Overview menu
Daily maintenance of the e 602 module 1106
Overview menu 1283
Weekly maintenance of the e 602 module 1110
Sample Data Clear window 1291
Every 2 weeks maintenance of the e 602
Reagent Preparing window 1292
module 1127
Reagent Detergent Volume Reset window 1294
Quarterly maintenance of the e 602
Inventory Set window 1295
module 1131
Calib. and QC Select window 1296
Maintenance as required on the e 602
Parameter Download window 1298
module 1137
Sample Tracking window 1301
Data Manager window 1305
Troubleshooting Communication Setting window 1306
Module window 1307
Cancel Maintenance window 1309
19 Data alarms
Reagent Overview window (ISE module) 1310
About data alarms and instrument alarms 1157
Reagent Overview window (c 701/c 702
List of data alarms for tests 1159
module) 1314
Data alarms of ISE module tests 1161
Detail area (c 701/c 702 module) 1318
Data alarms of photometric tests 1174
Reagent Manager Overview window (c 702
Data alarms of immunology tests 1190
module) 1320
Alarms for calibrations 1206
Detail window (c 702 module) 1324
Data alarm for QC materials 1221
Take Out window 1326
Data problems without alarm 1224
Reagent Pack Unloading Area window (c 702
Rerun test list 1228
module) 1327
Reagent Overview window (c 502 module) 1329
20 Troubleshooting
Detail area (c 502 module) 1333
General troubleshooting information 1233
Reagent Overview window (e 801 module) 1335
General troubleshooting of the instrument 1238
Detail area (e 801 module) 1340
Troubleshooting on the ISE module 1243
Temperature window (e 801 module) 1343
Troubleshooting on cobas c modules 1249
Troubleshooting on cobas e modules 1260
Roche Diagnostics
22 Global buttons and windows 24 Reagent menu

Overview 1357 Setting submenu 1549
Stop window 1362 Abbreviations of reagents 1556
Logoff window 1363 Reagent Registration window 1558
Logon window 1364 Reagent Prime window 1560
S. Stop window 1365 Manual Registration (C Module) window 1563
Alarm window 1366 R. Pack Set Information window (c 702/c 701
Sound window 1369 module) 1564
Monitor window 1370 R. Pack Set Information window (e 801
Print window 1372 module) 1566
History window 1374 R. Pack Unloading window (c 702 module) 1567
Print Range window 1377 R. Pack Unloading window (c 502 module) 1568
Reports 1378 R. Pack Unloading window (e 801 module) 1569
Workplace print window 1379 Development Channel window 1570
Reagent print window 1393 Status submenu 1572
Calibration print window 1400 Inventory Set window 1578
QC print window 1418
Utility print window 1422 25 Calibration menu
Automatic Calibration Monitor report 1454 Status submenu 1581
Automatic Maintenance reports 1463 Calibration Trace window 1586
Start window 1473 Scale window - Calibration Trace 1591
Start Up Pipe Setting window 1477 Comment window 1592
Automatic Rerun window 1478 Calibration Result (ISE) window 1593
Time To Unload window (c 702 module) 1479 Calibration Result (Photometry) window 1595
Rack Reception Mode window 1480 Calibration Result (Immune) window 1599
CLAS Connection window 1481 Working Information window 1604
Masking window 1482 Scale window - Working Information 1607
Module Masking window 1484 Reaction Monitor window 1608
Default Profile window 1486 Scale window - Reaction Monitor 1611
Confirmation window 1487 Instrument Factor window 1612
No help available 1488 Start Up Setting window 1614
Calibrators submenu 1616
23 Workplace menu Rack Assign window 1619
Test Selection submenu 1491 Install submenu 1621
Sample Information window 1499 Add window 1624
Barcode Read Error window (barcode Detail window 1625
mode) 1500 Edit window 1626
Rerun Rack Assignment window (non-barcode Download window 1628
mode) 1502 Confirmation window 1630
Repeat window (non-barcode mode) 1503
Data Review submenu 1504 26 QC menu
Read Backup window 1511 Status submenu 1635
Filter window 1512 Stand By Bottle QC window 1638
Search Sample window 1514 Unloading window 1640
Unload Rack window 1516 Run Status submenu 1641
Change Priority window 1517 Controls submenu 1644
Send to DM window 1518 Rack Assign window 1646
Backup Data window 1520 Install submenu 1648
Test Review window 1522 Add window 1650
Reagent Detail window 1528 Detail window 1651
Original Data window 1529 Download window 1652
All Results window 1533 Confirmation window 1654
Reaction Monitor window 1537
Scale Setting window 1540
Overlay window 1541
Calib. Review submenu 1544
Roche Diagnostics
27 Utility menu Download window 1874

System submenu 1661 System Configuration submenu 1876
Input Operator ID window 1664 Test Assignment window 1877
Operator List window 1665 Test Assignment (ISE) window 1878
Access levels of each menu and window 1666 Test Assignment (c 701/c 702) window 1879
Add window 1675 Test Assignment (c 502) window 1881
Password Protection window 1676 Test Assignment (e 801) window 1882
Rack Assignment window 1677 Test Assignment (e 602) window 1884
False Bottom Settings window 1686 Module Settings window 1886
Barcode Settings window 1688 CLAS Settings window 1887
Data Manager Settings window 1690
Key Settings window 1695
Test Key Setting window 1697
Basic analytical principles
Profile Setting window 1698
Print Settings window 1700 28 Measurement technology
Comment Titles window 1701 About ISE technology 1893
Display Settings window 1702 About photometric technology 1898
Rack Reception window 1704 About the ECL technology 1906
Analyzer Settings window 1706
Wash Racks window (chemistry) 1707 29 Test principles
Rack Delivery window 1708 About ISE test principles 1917
Maintenance Settings window 1710 About photometric test principles 1918
Edit window 1711 About serum index principles 1937
Pipe Settings window 1713 Overview of immunology principles 1941
Edit window 1715
Power Up Pipe window 1717 30 Calibration principles
Reagent Manager Settings window (c 702 About calibration of ISE tests 1951
module) 1718 About calibration of photometric tests 1955
Immune Analyzer Settings (e 801 module) 1719 Calibration of immunology tests 1979
Alarm Settings window 1722
Result Upload Settings window 1725 31 Rules for attaching data alarms
Calib. and QC Settings window 1727 About data alarms rules for photometric
Reagent Level window 1729 tests 1989
Utility Reagent Settings window
(photometric) 1731
R. Packs Setting window (c 701/c 702
Appendix
module) 1736
R. Packs Setting window (c 502) 1738 32 Specifications
ISE Calib. Settings window 1740 General specifications 2005
Reagent Loading Level window (c 702) 1741 Specifications of the control unit 2012
Maintenance submenu 1744 Specifications of the core components 2013
Maintenance Monitor window 1746 Specifications of the ISE module 2015
Maintenance item windows 1747 Specifications of the cobas c modules 2017
Maintenance check windows 1787 Specifications of the cobas e modules 2020
Application submenu 1816 List of available accessories and
R. Packs Setting window (c 701/c 702) 1846 consumables 2024
R. Packs Setting window (c 502) 1848 Specifications of barcodes 2038
Download window 1850
Confirmation window 1853 33 Glossary
Special Wash submenu (photometric and e 602 Index 2045
tests) 1855
Reagent Probe window (photometric) 1857
Edit (Reagent Probe) window (photometric) 1860
Reagent Probe window (e 602) 1862
Edit (Reagent Probe) window (e 602) 1865
Cell window (photometric) 1867
Edit (Cell) window (photometric) 1870
Sample Probe window 1871
Edit (Sample Probe) window 1873
Roche Diagnostics
Roche Diagnostics
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Intended use
Intended use for US only The cobas® 8000 modular analyzer series is an automated
analyzer, intended for running qualitative, semi-
quantitative and quantitative clinical chemistry and
immunochemistry assays as well as ion-selective
measurements.
Supporting information for US only The cobas® 8000 modular analyzer series is an in vitro
diagnostic (IVD) medical equipment.
Intended purpose for EU/EFTA and outside US The cobas® 8000 modular analyzer series is an automated
analyzer, intended for running qualitative, semi-
quantitative and quantitative clinical chemistry and
immunochemistry assays as well as ion-selective
measurements.
Supporting information for EU/EFTA and It is an IVD device intended to be used in combination with
outside US assays for screening, monitoring (aid in monitoring),
diagnosis (aid to diagnosis) and prognosis; additionally, the
device can be used to run companion diagnostic tests.
The specific disorder and testing populations are covered

by the applicable assays running on the instrument. The
type of specimen to be used includes serum, plasma, urine,
whole blood, cerebrospinal fluid, supernatant, oral fluid,
hemolysate, amniotic fluid and processed stool, that are
used for detecting and/or measuring analytes covered by
the specific assays. The intended users of this device are
trained laboratory technicians and trained field service
engineers (professional use only). Inside EU/EFTA only, the
cobas 8000 e 801 is also intended for use in blood donor
screening in hospital blood banks, blood bank labs, and for
blood donation testing at plasma fractionators.
Roche Diagnostics
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Symbols and abbreviations
Product names Except where the context clearly indicates otherwise, the
following product names and descriptors are used.
Product name Descriptor

cobas® 8000 modular analyzer System
series
cobas® 8000 data manager Data manager
cobas® ISE module ISE module
cobas c 702 module c 702 module
cobas e 801 module e 801 module
cobas e 602 module e 602 module
cobas c pack reagent cassette
cobas e pack reagent cassette
cobas e pack green reagent cassette
cobas e flow cobas e flow test
Self-Contained ISE Support Box ISE support box
Sample Cup standard cup
Micro-Sample Cup micro cup
Sarstedt micro tube cryo cup
AssayTip/AssayCup tray magazine
WasteLiner solid waste box
y Product names
Symbols used in the publication

Symbol Explanation
o List item
u Related topics containing further information
Tip. Extra information on correct use or useful
q
hints
r Start of a task
I Extra information within a task
f Result of an action within a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics
p Task. Used in cross-references to tasks
Figure. Used in figure titles and cross-
w
references to figures
Table. Used in table titles and cross-references
y
to tables
Equation. Used in cross-references to
z
equations
y Symbols used in the publication
Roche Diagnostics
19
Symbols used on products

Symbol Explanation
Global Trade Item Number
Consult instructions for use on this website:

dialog.roche.com
Quantity contained in the package
Quantity contained in the package
Product order
Serial number
Date of manufacture
Manufacturer
Orientation of the package during

transportation
Authorized representative in the European

Community
Indicates the entity importing the medical

device into the European Union.
Complies with the directives on the restriction

of hazardous substances.
y Symbols used on products
Roche Diagnostics
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Symbol Explanation
Unique device identifier
Indicates that the equipment is suitable for

alternating current only.
Catalogue number
Lot number
Single use
Use by date
Humidity limit
Temperature limit
Caution
y Symbols used on products
Roche Diagnostics
21
Abbreviations The following abbreviations are used:
Abbreviation Definition
ACN Application Code Number
ADC Analog-digital converter
ANSI American National Standards Institute
CC CleanCell, wash solution for measuring
cells after measurement
CellCln1 Basic reaction cell wash solution
(NaOH-D)
CellCln2 Acid reaction cell wash solution
CFAS Calibrator for automated systems
(C.f.a.s.)
CFR Code of Federal Regulations
CSA Canadian Standards Association
CSV Comma-separated values
CV Coefficient of variation
DIL ISE Diluent
EC European Community
ECL Electrochemiluminescence
ECO-D EcoTergent, additive to the incubation
bath to reduce surface tension
EFTA European Free Trade Association
EN European standard
FCC Federal Communications Commission
GNU GNU’s Not Unix!
HIS Hospital information system
ICVC Initial cassette volume check
IEC International Electrotechnical
Commission
IS ISE Internal Standard
ISE Ion-selective electrode
ISE COMP ISE Standard High, used as calibrator 3
ISE HIGH ISE Standard High, used as calibrator 2
ISE LOW ISE Standard Low, used as calibrator 1
ISO International Organization of
Standardization
IVD In vitro diagnostic
IVDR In vitro diagnostics regulation
LED Light-emitting diode
LIS Laboratory information system
LLD Liquid level detection
MSB Module sample buffer
n/a Not applicable
NACL NaCl solution, used as diluent
NaOHD Wash solution for reagent probes and
reaction cells (D1)
OBS On-board stability
y Abbreviations
Roche Diagnostics
22
Abbreviation Definition
PC ProCell, signal generating buffer for the
ECL detection
QC Quality control
RCM Reaction calculation mode
REF ISE Reference Electrolyte solution
RFID Radio-frequency identification
RM Reagent manager
RoHS Restriction of hazardous substance
RR Reagent rotor
SCCS Additive to prevent reaction cell
carryover in long HbA1c batches (D3)
SD Standard deviation
SLLD Sample liquid level detection
SmpCln1 Basic sample probe wash solution
SmpCln2 Acid sample probe wash solution
SMS Wash solution for reagent probes and
reaction cells (D2)
STAT Short turn-around time
SysClean ISE Cleaning Solution/Elecsys SysClean
UL Underwriters Laboratories Inc.
USB Universal serial bus
WB Washing buffer
WEEE Waste Electrical and Electronic
Equipment
y Abbreviations
Roche Diagnostics
23
What is new in publication version 5.7?
This section provides an overview of all major changes in

this publication and the software.
Intended use for US only The description of the Intended use for US only has been
revised.
u Intended use (17)
Samp.O immunology data alarm The description of causes for the Samp.O data alarm for
immunology tests has been revised.
u Samp.O (1201)
Unmask e 801 loading port after RFID reading The procedure to unmask a loading port on the e 801
error module after RFID reading errors occurred has been
revised.
u Problem with a loading port due to RFID reading errors
on the e 801 module (1260)
Expired Reagent Flag The explanation of the Expired Reagent Flag has been
revised. If the check box is cleared, the affected data
alarms will not be sent to the data manager nor to the LIS.
u Expired Reagent Flag (1723)
Technical Limit for QC Results (e 801) A new check box to apply the technical limit check for QC
results on e 801 has been added to the Alarm Settings
window with software version 06-09.
u Technical Limit for QC Results (e 801) (1723)
ISE water consumption The maximum water consumption of the ISE module is
mentioned (6 L/h).
u Specifications of the deionized water supply and
consumption (2009)
Roche Diagnostics
24

IVDR update The following sections have been updated to comply with
the latest in-vitro diagnostics regulation:
u Publication information (2)
u Contact addresses (9)
u Intended use (17)
u Symbols and abbreviations (18)
u Fluorinated greenhouse gas (2008)
u List of other accessories and consumables (2036)
Immediate action in an emergency A new safety message explains what to do in an emergency

situation when the system cannot be controlled.
• Safety Guide > Warning messages > Electrical safety >
Immediate action in an emergency situation
Flammable refrigerant A flammable refrigerant is now used in the cooling units of

the newer c 702, c 701, and e 801 modules.
• Safety Guide > Warning messages > Flammable material
> Flammable refrigerant
• Safety Guide > Product safety labels > List of product
safety labels
• Safety Guide > Product safety labels > Product safety
labels on the c 702 module
labels on the c 701 module
labels on the e 801 module
(2) ISE Check cycles The maintenance check (2) ISE Check is now run
consistently with 30 cycles in all maintenance actions
concerned.
u To perform an ISE check and calibrate the ISE
units p (867)
u To replace the ISE pinch valve tubing p (872)
100 mm tubes for QC material A new tip helps you to use 100 mm tubes for QC material.
u List of false bottom tubes (2034)
Roche Diagnostics
25

this publication and in the software.
Protection of personal data The General Data Protection Regulation (GDPR) is a

regulation on data protection and privacy for all citizens of
the European Union (EU) and the European Economic Area
(EEA). The regulation also covers the processing of
personal data outside the EU and EEA areas. In V5.5, new
safety precautions explain how to meet the GDPR in order
to prevent data breaches.
• Safety Guide > Safety precautions > Protection of
personal data and software security
Extended Power on/off The extended power-on and power-off procedures have
been revised.
u Powering on cobas e modules after extended power-
off (270)
u Powering off the instrument (623)
Third-party QC material Third-party QC material is a non-Roche QC material for

which the parameter file can be downloaded from
cobas® link. The system handles third-party QC results
identical to QC results generated with Roche QC material.
However, you must observe specific rules for rack loading
and the applicable container types for third-party QC
material.
u About automated third-party QC materials (517)
Loading rack trays without gaps between After placing a rack tray in the input buffer, move the racks
racks to the front of the tray to ensure that there are no gaps
between racks.
u Handling samples (564)
u Loading routine samples (568)
HbA1c test on the c 502 module All references to the outdated HbA1c test gen. 2 have
been eliminated.
u About the HbA1c test on the c 502 module (721)
u About result calculation of the HbA1c test (722)
u Installing the HbA1c test on the c 502 module (723)
Interlock Manual The Interlock Manual V2.1 for the c 502 module has been
integrated into this user documentation.
u Maintenance as required on the c 502 module (with
interlock release tool) (1027)
Roche Diagnostics
26
List of cleaning solutions For alcohol, there is now a recommended concentration of

70%. The 0.5% sodium hypochlorite solution has been
deleted from the list as it is no longer needed for cleaning
the water containers.
u List of cleaning solutions (815)
Cleaning the water containers Monthly disinfection with alcohol of the liquid level sensor
assembly and the interior surface of the water container is
now mandatory. Scrubbing the interior surface of the tank
with a brush has been replaced by wiping it thoroughly with
a lint-free cloth. Arm-length gloves are needed for that.
u Cleaning the water containers of the core unit and the
MSBs (826)
Cleaning racks A new maintenance action has been added.

u Cleaning racks (834)
Foam in PreClean II M bottles Safety messages have been added to maintenance actions
of the e 801 module to remind you to open and close the
front door gently in order to avoid the formation of foam in
PreClean II M bottles. This concerns maintenance actions
such as:
u Cleaning ProCell aspiration pipes of the e 801
module (1058)
u Cleaning CleanCell aspiration pipes and bottle stand of
the e 801 module (1087)
Pinch valve tubing on the e 602 module The replacement interval has been stated with more
clarity: Every 3 months, or after measuring 25 000 tests
per measuring cell, whichever comes first.
u Replacing the pinch valve tubing of the e 602
module (1131)
Masking window The description of the Mask on scheduling within module

check box has been revised.
u Masking window (1482)
Reformatter racks Reformatter racks may be used on instruments connected

with a cobas® 8100 automated workflow series.
u List of reformatter racks (2029)
13 mm tubes on racks without cup adapters If the system is connected to a cobas® 8100 automated
workflow series, cup adapters for 13 mm sample tubes may
be omitted under certain conditions.
u 13 mm tubes on racks without cup adapters (2030)
Sample barcodes The barcode type ISBT 128 Donation Identification Number
is now supported. The specifications of Codabar (NW-7)
and Code 39 have been amplified.
u Specifications of sample barcodes (2039)
Roche Diagnostics
27

Safety Guide A warning message about Sharps, rough edges, and/or

moving parts has been added to the Safety guide.

Safety Guide The description about Data security has been revised.
Instrument approvals The following standards have been deleted from the
instrument approvals:
• IEC 61010-2-081 and A1
• UL 61010-1
• CAN/CSA C22.2 No. 61010-1CAN/CSA C22.2
No. 61010-2-101CAN/CSA C22.2 No. 61010-2-081
u Instrument approvals (8)
Extended Power off and on The description for extended power-on and power-off has
been reworked.
off (270)
Reagent loader e 801 The description and naming of the status indicator and
reset button has been reworked.
New function, expired ProCell II M bottles are masked

automatically, has been described.
Roche Diagnostics
28

Sample foam detection This document contains a revision/addition to the following

sections:
This revision was necessary due to the activation of the

sample foam detection with camera for the e 801 module.
u Defining settings for the e 801 module (695)
u Immune Analyzer Settings (e 801 module) (1719)
u Samp.B (1200)
u Specifications of the sampling system of cobas e
modules (2022)
Specifications of radio equipment The c 701, c 702, and e 801 modules contain RFID
readers.
u Specifications of radio equipment (2008)

ISE support box The ISE support box is used in conjunction with the
ISE module and is available for the cobas® 8000 modular
analyzer series without a cobas c 702 module or
cobas c 701 module in the configuration.
u The Self-Contained ISE Support Box (133)
Cleaning rack trays The cleaning procedure for rack trays has been added.
u Cleaning the rack tray (835)
Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the
hermetically sealed refrigeration.
Update of cobas® link information Update of the cobas® link chapter.

u Overview of cobas® link (246)
Roche Diagnostics
29

New layout and structure Resulting from customer feedback, we have updated the
layout and the structure of this publication to help you find
information easier and perform tasks quicker.
cobas e flow (e 801 module) cobas e flow is a feature of the data manager and the
e 801 module. cobas e flow tests are a pre-defined
combination of conventional immunology tests.
cobas e flow tests can be ordered from the data manager

and the host. They are managed via the data manager. The
involved immunology tests are performed automatically on
the e 801 module.
u About cobas e flow tests on the e 801 module (391)
Multi-application tests (e 801 module) Multi-application tests use the same reagent cassette, but
with different measurement protocols from different
applications.
Up to 4 applications can be part of 1 multi-application test.

The different applications have different ACNs. Multi-
application tests are pre-defined in the application file.
Unlike cobas e flow tests, multi-application tests can be

ordered manually on the control unit or automatically by
the host.
u About multi-application tests on the e 801
module (398)
Quick Start Mode (e 801 module) When you enable the quick start mode, the instrument can
start a run in approximately 6:30 minutes instead of about
12 minutes. Some steps, such as the reagent prime, are
only performed once when the instrument is powered on,
not during preparation for a run. You need administrator
access rights to enable the quick start mode.
u About the quick start mode on the e 801 module (696)
Roche Diagnostics
30

this publication and software version 05-01.
This version requires Windows 7 on the control unit,

Windows XP is not supported.
Mixing sample types and container types on a You can consolidate different sample types and container
rack types on a single rack. Sample consolidation can be useful,
for example, if the instrument is connected with a CLAS.
The CLAS can use the same rack range for pre-processing
of different samples types.
On the Standard tab of the Rack Assignment dialog box,

you must define a rack range for the sample type None to
consolidate samples. The information about the sample
type and in some cases also the information about the
container type is sent via HL7 protocol to the control unit.
u About mixing different sample types and container
types on a rack (567)
Reagent registration by maintenance pipe You can include registration of reagents in a maintenance
pipe. Then new reagents are registered on c 701/c 702
modules and the maintenance action inventory update is
performed on e 602 modules.
If you execute a maintenance pipe with this option, you do

not need to register new reagents manually. After
returning from manual cleaning mode, the required
reagent registration can be executed by a maintenance
pipe. If the reagent registration was already performed
before, it is skipped in the maintenance pipe.
u Creating a maintenance pipe (787)
Overwriting editable parameters when When you download an updated application from the data
updating an application manager, you can now choose between the Overwrite
option and the Partial Overwrite option:
• To download the application with all new settings,
choose the Overwrite option.
• To keep the settings of all editable application settings,
choose Partial Overwrite option.
In previous software versions, editable application settings

were not updated when you downloaded an updated
application from the data manager.
u About updating application settings (715)
List of editable application settings (716)
New ISE calibration scheme ISE Standard High is also used as compensator (S3).
u About calibration methods for ISE tests (470)
Roche Diagnostics
31
Further changes and improvements • By limiting the number of racks on the instrument via
the new Rack Delivery dialog box, the turnaround time
of racks is improved.
• Integration of ISE data alarms: If an ISE.N or ISE.E data
alarm occurs, it is attached to all ISE test results for this
sample.
• For ISE calibrations, the software now uses separate
compensated limit checks for slope and calibrator S3
concentration.
• The user rights for downloading application settings,
calibrator data, QC material data, and special wash
data are reorganized.
u For links to the associated topics, refer to the Online
Help.
u Defining settings for rack delivery (691)
u ISE.E (1167)
ISE.N (1168)
u Calib. (ISE tests) (1828)
u Downloading and updating application settings (710)
Installing calibrator data from the data manager (488)
Installing QC material data from the data
manager (531)
Downloading special wash data (752)
Roche Diagnostics
32
Roche Diagnostics
Operation
1 Safety guide...........................................................................................35
2 Overview of the system ...................................................................... 103
3 Overview of operation ........................................................................ 221
4 Before operation................................................................................. 255
5 Reagents ............................................................................................ 303
6 Calibration .......................................................................................... 463
7 Quality control.................................................................................... 511
8 Orders and results .............................................................................. 539
9 After operation ................................................................................... 605
10 Special operation ............................................................................... 637
11 Configuration...................................................................................... 651
Roche Diagnostics
35
Table of contents
Safety guide 1
In this chapter 1
Safety classifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Safety precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
About operator qualification . . . . . . . . . . . . . . . . . . 38
About safe and proper use of the system . . . . . . . 39
About installation and deinstallation . . . . . . . . . . . 40
About environmental conditions . . . . . . . . . . . . . . . 41
About the protection of personal data and
software security . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Warning messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Sharps, rough edges, and/or moving parts . . . . . . 46
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Flammable material . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Biohazardous materials. . . . . . . . . . . . . . . . . . . . . . . 48
Waste. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Mechanical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Reagents and working solutions . . . . . . . . . . . . . . . 58
Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Circuit breakers and fuses . . . . . . . . . . . . . . . . . . . . 59
Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Magazine drawer (e 801 and e 602 module) . . . . . 60
Preparation table (c 502 module) . . . . . . . . . . . . . . 60
Transfer mechanism (c 702 module). . . . . . . . . . . . 60
Product safety labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
List of product safety labels. . . . . . . . . . . . . . . . . . . 61
Product safety labels on the core unit . . . . . . . . . . 63
Product safety labels on the ISE module . . . . . . . . 65
1 Safety guide
Product safety labels on the c 702 module . . . . . . 68

Product safety labels on the e 801 module . . . . . . 80
Product safety labels on the e 602 module . . . . . . 89
Safety information for barcode readers . . . . . . . . . . . . 94
About the laser barcode reader . . . . . . . . . . . . . . . 94
About the LED barcode readers . . . . . . . . . . . . . . . 95
Roche Diagnostics
36
Table of contents
Safety interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
About electronic safety interlock for various
covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Resuming operation after a stop by safety
interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
About mechanical safety interlock of top cover on
e 801, c 702 and c 701 modules . . . . . . . . . . . . . . 99
Safety information for disposal . . . . . . . . . . . . . . . . . . . 101
Disposal information . . . . . . . . . . . . . . . . . . . . . . . . . 101
1 Safety guide
Roche Diagnostics
Safety classifications 37
Safety classifications
The safety precautions and important user notes are
classified according to the ANSI Z535.6 standard.
Familiarize yourself with the following meanings and icons:
! Safety alert
r The safety alert symbol is used to alert you to potential
physical injury hazards. Obey all safety messages that
follow this symbol to avoid possible damage to the
system, injury, or death.
These symbols and signal words are used for specific

hazards:
! WARNING
Warning…
r …indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
! CAUTION
Caution…
r …indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
NOTICE
Notice…
…indicates a hazardous situation which, if not avoided, may
result in damage to the system.
Important information that is not safety relevant is

indicated with the following icon:
q Tip…
1 Safety guide
…indicates additional information on correct use or useful

tips.
Roche Diagnostics
38 Safety precautions
Safety precautions
! To avoid serious or fatal injury, read and
comply with the following safety precautions.
The hazard warnings in the Safety Guide, in the Operator’s

Manual, in the Online Help, and on the instrument cannot
cover every possible case, as it is impossible to predict and
evaluate all circumstances beforehand.
Just following the given directions may, therefore, be

inadequate for operation. Always be alert and use your
common sense.
In this section
About operator qualification (38)
About safe and proper use of the system (39)
About installation and deinstallation (40)
About environmental conditions (41)
About the protection of personal data and software
security (42)
About operator qualification
Insufficient knowledge and skills As an operator, ensure that you know the relevant safety
precaution guidelines and standards, and the information
and procedures contained in these instructions.
r Do not carry out operation and maintenance unless you
have been trained by Roche Diagnostics.
r Leave maintenance, installation, or service that is not
described to trained Roche Service representatives.
r Carefully follow the procedures specified in the
instructions for operation and maintenance.
r Follow Good Laboratory Practices, especially when you
work with biohazardous material.
1 Safety guide
Roche Diagnostics
Safety precautions 39
About safe and proper use of the system
Missing personal protective equipment Working without personal protective equipment means
danger to life or health.
r Wear appropriate personal protective equipment,
including, but not limited to, the following items:
o Eye protection with side shields
o Fluid-resistant laboratory coat
o Approved lab gloves
o Face shield if there is a chance of splashing or
splattering
Fatigue due to long hours of operation Looking at the monitor over an extended time may lead to
eye strain or body fatigue.
r Take a break to relax, in accordance with your local
regulations.
System not used for an extended period r Follow the decommissioning procedure.
r Set the power switch to OFF if you do not use the
system for an extended period.
r Remove and refrigerate any remaining reagents.
r For further information, call your Roche Service
representative.
Abnormal condition During operation, always check for any abnormal sound,
water leakages, or other abnormal conditions.
r If a trouble occurs, take suitable safety measures
according to the condition and contact your Roche
1 Safety guide
Non-approved parts Use of non-approved parts or devices may result in

malfunction of the system and may render the warranty
null and void.
r Use only parts and devices approved by Roche
Diagnostics.
Roche Diagnostics
About installation and deinstallation
Errors in installation Only trained Roche Service representatives may install the
system.
r Leave installation that is not described to trained
Roche Service representatives.
Damage in transit r Do not attempt to relocate or transport the system.

r Leave relocation and transportation to Roche Service
representatives.
Disposal An infectious system may lead to infection.

r If you must dispose of the system, read the following
information.
u Disposal information (101)
1 Safety guide
Roche Diagnostics
About environmental conditions
Unsuitable environmental conditions Operation outside of the specified ranges may lead to
incorrect results or malfunction of the system.
r Use the system indoors only, and avoid heat and
humidity outside of the specified range.
r Make sure that the system's ventilation openings
remain unobstructed always.
r To maintain the environmental conditions of the
system, perform maintenance in accordance with the
specified intervals.
r Keep the operating instructions undamaged and
available for use. Operating instructions must be easily
accessible for all users.
Power interruption A power failure or momentary drop in voltage may damage

the system or lead to data loss.
r Operate only with an uninterruptible power supply
(UPS).
r Ensure periodic maintenance of the UPS.
r Perform regular backups of results.
r Do not switch off power while the control unit accesses
the hard disk or a storage medium.
1 Safety guide
Roche Diagnostics
About the protection of personal data and software

security
The General Data Protection Regulation (GDPR) is a
regulation in EU law on data protection and privacy for all
citizens of the European Union (EU) and the European
Economic Area (EEA). The regulation also covers the
processing of personal data outside the EU and EEA.
If this regulation or any other privacy protection regulation

is applicable for your country, observe the following safety
messages to prevent data breaches and to meet the GDPR:
Access control Unauthorized access may lead to data breaches.

r Implement physical access controls to ensure that only
authorized laboratory staff operate the system at all
times.
r Assign a personal, unique user ID to each user for
system access.
r Assign access rights to each user only as high as
required for the tasks of the user.
r Delete user IDs from the system for users who no longer
work on the system.
Corrupt data due to a disclosed password The security of the system and its data depends on the
password-protected access. If an unauthorized person
discovers your user ID and password, they could
compromise this security.
r Always enter your password unobserved.
r Do not write down your password anywhere, including in
a contact form, in the address book, or in a file on the
computer.
r Do not disclose your password to anyone. Roche will
never ask you for your password.
r If you ever disclose your password to anyone, change it
immediately afterwards.
1 Safety guide
r Contact your local Roche affiliate if you think your

account has been compromised.
Roche Diagnostics
Network security Malicious software and hacker attacks may impair IT

security. The laboratory is responsible for the IT security of
their IT infrastructure.
r To protect and separate Roche systems from other
laboratory infrastructure, the Roche-provided firewall
must be used.
r Secure all devices and services used in the lab
infrastructure against malicious software and
unauthorized access.
r Secure the network environment to be resilient against
traffic redirection and eavesdropping.
Data entry and data transfer Writing patient sensitive information in comment fields can
violate protection laws for protected health information.
r Do not write any patient sensitive information into
comment fields.
r Do not download patient identifiers from any host
system (e.g., LIS, middleware, or HIS) onto the system.
Data transfer using any host protocol (e.g., HL7, ASTM)
is not encrypted; data is transferred as plain text and
readable with packet analyzer tools such as Sniffer.
Secure data storage Unauthorized access to data backups and archive files can
violate data protection laws.
r Any data backup or data archive that has been
exported from the instrument must be physically stored
in a secured location.
r Ensure only authorized persons may access the secure
data storage. This includes the data transfer to remote
storage locations and disaster recovery.
r Data backups must not be taken from the secure data
storage. Do not take storage media outside the lab
environment.
1 Safety guide
Roche Diagnostics
Cybersecurity and privacy awareness Insufficiently informed employees can endanger security.
r Perform regular cybersecurity and privacy awareness
trainings for laboratory staff handling personal data.
Instruct laboratory staff how to handle data in a
compliant way and according to the privacy principles
as mandated by customer regulations.
r Check your instrument for suspicious activity and
report any suspected compromise to your local Roche
representative immediately.
r Update to the latest software versions provided by
Roche as soon as possible.
r Do not use external storage devices or storage media
(e.g., USB flash drives or DVDs) on the system that have
been used on public or private computers. Failure to do
so may result in data loss and render the instrument
unusable.
r Do not connect external storage devices to the USB
ports on the system, unless instructed to by the user
documentation or by a Roche Service representative.
Use of storage media Incorrect handling of storage media may result in data loss
or system malfunction.
r Insert or remove a DVD only when the instrument is in
Standby mode.
r Do not use low quality or damaged DVDs (e.g.,
scratches, dirt, or dust on disks).
Computer viruses If you detect an unexpected operation or program/data

damage, the PC may be infected with a computer virus.
r To avoid virus infections, scan removable storage
media by an antivirus software before using them on
the system.
r Never use a program or storage medium that is
suspected of containing a virus.
r If you think your PC is infected with a computer virus,
1 Safety guide
call your local Roche Service representative. Your local

Roche Service representative will check your system for
proper functionality.
Roche Diagnostics
Data backup Data may get lost due to hard disk failure or damage.
r Back up your data (measurement results and system
parameters) at regular intervals.
r Use the backup function daily to store relevant data on
the hard disk.
r Make a backup copy if you have changed any system
parameters.
Non-approved third-party software Installation of any third-party software that is not approved
by Roche Diagnostics may result in incorrect behavior by
the system.
r Do not copy or install any software or software patches
on the system unless it is part of the system software or
your Roche Service representative advises it.
r Do not change any PC settings.
1 Safety guide
Roche Diagnostics
46 Warning messages
Warning messages
! List of warning messages
Failure to observe warning messages may result in death or
serious injury.
r Before operating the system, read the warning
messages carefully.
In this section
Sharps, rough edges, and/or moving parts (46)
Electrical safety (47)
Flammable material (47)
Biohazardous materials (48)
Waste (50)
Results (51)
Sharps, rough edges, and/or moving parts
Personal injury and infection due to sharps, Good Laboratory Practice can reduce the risk of injury. Be
rough edges, and/or moving parts aware of your laboratory environment, well-prepared, and
follow the instructions for use.
Some areas of the instrument may have sharps, rough
edges, and/or moving parts.
r Wear personal protective equipment to minimize the
risk of injury from bodily contact with such parts,
especially in less accessible areas, or while cleaning
the instrument.
r Your personal protective equipment should be
appropriate to the degree and type of potential hazard,
e.g. suitable lab gloves, eye protection, lab coat, and
footwear.
1 Safety guide
Roche Diagnostics
Warning messages 47
Electrical safety
Electric shock Removing the covers of electronic equipment can cause

electric shock because there are high-voltage parts inside.
r Do not attempt to work in any electronic equipment.
r Do not remove any cover of the system except those
covers specified in the Operators Manual.
r Do not open the top cover and touch the ultrasonic
mixing unit during operation or when the analyzer
performs maintenance.
r Only Roche Service representatives may install,
service, and repair the system.
Immediate action in an emergency situation If an unexpected emergency situation appears and the
system cannot be controlled, this can lead to injury of the
operator.
r Turn off the operation main switch or circuit breaker of
the affected module.
r Disconnect the power supply cord of the affected
module.
r If a generic emergency situation appears, that cannot
be allocated to a specific module, turn off the core
unit's power supply.
Flammable material
Flammable refrigerant The cooling unit of certain c 701, c 702, and e 801
modules contains flammable refrigerant.
r The corresponding module can be identified by a Risk of
Fire safety label.
r Do not remove any cover of the system except those
specified in the instructions.
1 Safety guide
r Leave maintenance, installation, or service that is not

described to trained Roche Service representatives.
Roche Diagnostics
48 Warning messages
Biohazardous materials
Infectious samples Contact with samples containing material of human origin

may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially infectious.
r Follow Good Laboratory Practices, especially when
working with infectious material.
r Keep all covers closed while the system is operating.
r Before you work with an opened cover, always switch
off the instrument or select a mode appropriate for the
particular maintenance action.
r Wear appropriate personal protective equipment.
r If any infectious material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.
Spilled sample The sample containers may vibrate during rack transport
and rotation of sample tubes. Sample may be spilled on the
transport mechanisms.
r Avoid overfilling sample tubes and cups.
r Only use specified sample tubes and cups.
r Leave approximately 10 mm clearance between the
liquid and the top of the sample tube or cup.
r After loading a rack tray on the input buffer, move the
racks to the front of the tray and ensure there are no
gaps between individual racks.
r If sample is spilled on the instrument, wipe it up
immediately and apply disinfectant. Be sure to wear
protective equipment.
1 Safety guide
Ultrasonic mixers Contact with splashes of reaction mixture or by inhaling

reaction mixture aerosol from the ultrasonic mixer may
result in infection.
r Keep all covers closed while the system is operating.
Roche Diagnostics
Warning messages 49
Sharp objects Contact with probes or nozzles may result in infection.

r When you wipe probes or nozzles, use a lint-free cloth
and wipe from top to bottom.
r Take care not to puncture yourself.
Take extra care when working with lab gloves, which
can easily be pierced or cut, leading to infection.
Moving parts Contact with moving parts may result in infection or

personal injury.
r Keep all covers closed and in place while the system is
operating.
r Before you work with an opened cover, always switch
off the instrument or select a mode appropriate for the
particular maintenance action.
r Only trained personnel should have access to the keys
to the covers of the instrument.
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r Only load or unload racks when the green status
indicators at the rack input buffer are lighting.
r During operation and maintenance, carefully follow the
Operator’s Manual.
1 Safety guide
Roche Diagnostics
50 Warning messages
Waste
Infectious waste Contact with waste (liquid and/or solid) may result in
infection. All materials and mechanical components
associated with the waste systems are potentially
infectious.
Take extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Waste must be treated in accordance with the relevant

laws and regulations. Any substances contained in
reagents, calibrators, and QC material, which are legally
regulated for environmental protection, must be disposed
of according to the relevant water discharge facility
regulations. For the legal regulations on water discharge,
contact local authorities.
Two kinds of liquid waste are discharged by the analyzer:

• Concentrated liquid waste that contains highly
concentrated reaction mixture. This waste must be
treated as infectious waste as specified by the relevant
regulations.
• Dilute waste: A non-concentrated liquid waste diluted
with rinsing water from reaction cell wash or water from
the incubation bath. When using NaOHD for washing
the reaction cells, alkaline concentration is 0.1 mmol/L
to 1.0 mmol/L.
Harmful fumes The combination of bleach with the contents of the liquid
waste container can cause potentially harmful fumes.
1 Safety guide
r Do not use bleach to clean the liquid waste container.
Environmental harm The system generates liquid and/or solid waste. This waste
contains concentrated reaction mixtures and is potentially
infectious. Improper disposal may contaminate the
environment.
r Treat this waste as infectious waste.
r Dispose of waste in accordance with the local
regulations.
Roche Diagnostics
Warning messages 51
Results
Accuracy and precision Incorrect results may lead to errors in diagnosis, posing
danger to the patient.
r For proper use of the instrument, perform QC
measurement and monitor the system during operation.
r Do not use reagents or consumables that have
exceeded their expiry date or onboard stability,
otherwise you may obtain inaccurate data.
r For diagnostic purposes, always assess the results with
the patient’s medical history, clinical examination, and
results from other consultations.
Regular cleaning and maintenance To prevent inaccurate results and unsafe operation of the
system:
r Regularly clean and/or decontaminate the instrument
as required. Follow Good Laboratory Practices for
cleaning and decontamination.
r Ensure that the laboratory is regularly cleaned and is
maintained in an orderly manner.
r Perform the maintenance actions according to the
given maintenance intervals.
Position mismatch when using non-barcoded Putting a sample container with a manually entered ID on a
samples wrong rack position or rack may lead to incorrect results.
r When operating in non-barcode mode, make sure to
load the samples according to the requisition list
provided by the instrument.
r Avoid empty positions within the racks. Do not place
non-registered samples in any empty rack position.
r When manually assigning positions, ensure that the
position is not already assigned.
1 Safety guide
Foam, clots, films, or air bubbles Incorrect results may occur due to foam, fibrin clots, films,
or air bubbles in reagents or samples.
r Avoid the formation of foam, clots, and air bubbles in all
reagents, samples, calibrators, and QC material.
Roche Diagnostics
52 Warning messages
Bubbles or foam inside a cobas c pack Bubbles or foam inside a reagent cassette may cause
inaccurate reagent pipetting and lead to incorrect results.
r Do not shake reagents.
r When loading a cobas c pack onto a c 701 module,
make sure that neither bubbles nor foam are present
inside the reagent cassette.
r If the instrument detects foam on the surface of the
reagent, this reagent cassette will be masked. Remove
this reagent cassette briefly until the foam disappears.
PC/CC cups Foam on the surface of the PC/CC cups may lead to
incorrect results.
r Before starting a run, check that no foam has
accumulated on the surface of the PC/CC cups.
r Clean the PC/CC cups if foam has accumulated.
Contaminated samples Insoluble contaminants, air bubbles, or films in samples

may cause clogging or pipetting volume shortage, leading
to incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.
r Ensure to prepare enough pipetting volume for
measurement.
Sample contamination If foreign material falls inside the input buffer of the core
unit, samples may get contaminated.
r Keep the cover of the input buffer closed while the
instrument is operating.
r Do not place anything on the cover of the input buffer.
Carryover Traces of analytes or reagents may be carried over from

one test to the next.
1 Safety guide
r Take adequate measures (for example, extra wash

cycles) to avoid extra testing and potentially incorrect
results.
Roche Diagnostics
Warning messages 53
Evaporation of samples or reagents Evaporation of samples or reagents may lead to incorrect

or invalid results.
r Sample material may evaporate if left open. Do not
leave samples open for any length of time.
r Do not use improperly stored reagents. Ensure that
reagents are stored according to the Instructions for
Use.
Incorrect reagent volume Incorrect reagent handling may cause an undetectable

loss of reagent.
r Always store reagents according to the specified
storage conditions as stated in the Instructions for Use
for the test.
r Reload a reagent cassette only if you are sure that the
reagent volumes remained unchanged while the
reagent cassette was not on the instrument.
r Do not reload a reagent cassette or a system reagent
bottle whose reagent has spilled.
r Do not use a reagent cassette on different instruments.
r Never refill a reagent cassette. Discard empty reagent
cassettes.
Expired reagents or mixing reagents Data obtained using expired reagents is not reliable. Mixing
new reagents with residues of old reagents may also lead
to incorrect results.
r Do not use reagents that have exceeded their expiry
date or onboard stability.
r Do not mix old reagents with new reagents.
When a bottle is empty, replace it with a new one.
Contaminated reagents Cleaning fluid or cleaning devices may enter through the
reagent pipetting openings during maintenance, which
leads to incorrect results.
1 Safety guide
r Place a paper towel over the reagent pipetting holes

during maintenance.
r During maintenance, carefully follow the Operator’s
Manual.
Incorrect temperature of reagents Incorrect temperature of reagents may lead to incorrect

results and influences the onboard stability of reagents.
r Keep all covers closed and in place.
r During operation and maintenance, carefully follow the
Operator’s Manual.
Roche Diagnostics
54 Warning messages
Incorrect temperature of incubation water Incorrect temperature of the incubation water may lead to
false results.
r Depending on the ambient temperature, it can take up
to 30 minutes after switching on the instrument or after
maintenance item (5) Incubation Water Exchange for
the incubator to reach the correct temperature.
Expired calibrators or QC material Data obtained using expired calibrators or QC material is

not reliable.
r Do not use calibrators or QC material that have
exceeded their expiry dates.
r Do not mix up calibrator containers or QC material
containers.
r Do not use target values for calibrators or QC material
from a different lot.
Missing covers of the ISE module If the cover of the ISE measuring compartment or the cover
of the ISE sipper nozzle are not reinstalled after
maintenance, the temperature and/or noise level may be
affected, leading to incorrect results. Touching any ISE
component or opening the front doors may also affect the
noise level and lower measurement precision.
r Only perform measurements if the covers of the ISE
module are installed.
r Do not open the front doors or covers during
measurement.
r Do not touch components of the ISE module during
measurement.
Aspiration of air Incorrect pipetting of the probes as well as incorrect

adjustment of the probe position may result in aspiration of
air, leading to incorrect results.
r Check the instrument performance by performing QC
measurements.
1 Safety guide
r Perform maintenance actions regularly.
Roche Diagnostics
Warning messages 55
Incorrect mixing volume The permissible volume of reaction mixture to be mixed by

the ultrasonic mixer is 100–250 µL. If the volume is outside
this range, the reaction mixture may not be mixed
correctly, leading to incorrect results.
r Make sure that the volume of reaction mixture stays in
the range of 100–250 µL, especially when loading a
new application onto the analyzer.
r For information on analytical parameters of each
reagent, contact its manufacturer.
Undetected scanning errors Barcode scanning errors can potentially go undetected

when a check digit is not used.
r Use only barcodes with check digits.
r Use only barcode labels of a good printout quality.
r Place barcode labels in appropriate position and
orientation on the sample containers.
r Do not move any samples that have already been
scanned.
r Do not add a non-barcoded sample into the position of
a sample with an unreadable barcode.
Electromagnetic compatibility This instrument complies with the standard

IEC 61326-2-6/EN 61326-2-6. It has been designed and
tested to CISPR 11 Class A. In a domestic environment it
may cause radio interference, in which case, you may need
to take measures to mitigate the interference.
The RFID readers in the system comply with the emission
requirements described in this part of the FCC CFR 47,
Part 15 Class A.
r The electromagnetic environment should be evaluated
prior to operation of the instrument.
r Do not operate this instrument in close proximity to
sources of strong electromagnetic fields (for example,
unshielded intentional radio frequency sources), as
they may interfere with proper operations.
1 Safety guide
r Do not operate the following devices in close proximity

to the instrument:
o Mobile phones
o Transceiver
o Cordless phones
o Other electrical devices that generate strong
electromagnetic fields
Roche Diagnostics
56 Caution messages
Caution messages
! List of caution messages
Failure to observe caution messages may result in minor or
moderate injury.
r Before operating the system, read the caution
messages carefully.
In this section
Mechanical safety (56)
Reagents and working solutions (58)
Mechanical safety
Maintenance or cleaning Contact with the instrument mechanisms during

maintenance or cleaning may result in personal injury.
r Before opening a cover for maintenance or cleaning,
always check the instrument status. Make sure that no
maintenance action or check is being performed.
r Keep all covers closed whenever performing a
maintenance action or check. If it is necessary to keep a
cover open, be careful not to touch anything other than
the aimed-at part.
r Make sure that the module is masked or the instrument
is in Standby mode before executing a maintenance
action or check.
r Before replacing any parts, make sure to power off the
instrument or the module.
Top cover dropping suddenly Be careful when opening or closing the top cover. If you let
go of the handle, the top cover may drop onto your fingers.
r Always keep a firm grip on the handle and do not let go
when opening or closing the top cover.
1 Safety guide
r If the top cover does not stay open properly, contact

your local Roche Service representative.
Open cover Injury to your head or body may be caused by an open

cover.
r Be careful not to hit yourself when working with open
covers (for example, during maintenance).
Roche Diagnostics
Caution messages 57
Rack transfer mechanism Personal injury may be caused by the rack transfer
mechanism.
r Only load or unload racks when the green status
indicators at the input/output buffer of the core unit
are on.
r Do not insert your fingers or any objects into the
input/output buffer while the instrument is operating.
r Keep all covers closed and in place while the instrument
is operating.
Reagent cassette piercer (c 502 module) The reagent cassette piercer is mounted on the
x-y-mechanism of the R1 reagent pipetter. The reagent
cassette piercer punctures the reagent bottle caps of the
reagent cassettes when they are registered for the first
time.
Contact with the reagent cassette piercer may result in
personal injury.
r Do not touch the reagent cassette piercer.
Reagent loader (e 801 module) When the reagent loader is moving up or down, your fingers
may be pinched between the reagent loader and the cover.
In case of an electrical power failure, the reagent loader
may descend by its own weight.
r Do not put your fingers or other body parts into the
reagent loader.
1 Safety guide
Roche Diagnostics
58 Caution messages
Reagents and working solutions
Skin inflammation or injury Direct contact with reagents, wash solutions, or other
working solutions may cause skin irritation, inflammation, or
burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Observe the instructions given in the Instructions for
Use.
r Observe the information given in Material Safety Data
Sheets (available for Roche Diagnostics reagents and
wash solutions).
r If reagents, wash solutions, or other working solutions
come into contact with your skin, wash the affected
area immediately with soap and water and apply a
disinfectant.
Fire and burns Alcohol is a flammable substance.

r Keep all sources of ignition (such as sparks, flames, or
heat) away from the system when you perform
maintenance or checks that involve alcohol.
r When you use alcohol on or around the system, use no
more than 20 mL at a time.
Insufficient amount of ECO-D Incorrect results may occur due to insufficient amount of
ECO-D. A reduced concentration of ECO-D may cause
bacterial growth in the incubation bath and may thus lead
to decreased measurement accuracy.
r Perform incubator bath cleaning at least once a month.
r Ensure that the ECO-D volume on board is sufficient
before starting the maintenance action.
r Perform maintenance action (5) Incubation Water
1 Safety guide
Exchange regularly.
Roche Diagnostics
Notices 59
Notices
! List of notices
Failure to observe the notices may result in damage to the
system.
r Before operating the system, read the notices
carefully.
In this section
Circuit breakers and fuses (59)
Spillage (59)
Magazine drawer (e 801 and e 602 module) (60)
Preparation table (c 502 module) (60)
Transfer mechanism (c 702 module) (60)
Circuit breakers and fuses
Circuit breakers and fuses Improper use may result in damage to the system.
r If one of the circuit breakers or fuses blows, do not
attempt to operate the system before contacting
either your Roche Service representative or technical
support.
Spillage
Spilled liquid Any liquid spilled on the system may result in malfunction
or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
1 Safety guide
the covers or other surfaces of the system.

r When you remove or replace consumables, do not spill
any liquid on the system.
r If liquid does spill on the system, wipe it up immediately
and apply a disinfectant. Wear appropriate personal
protective equipment.
Dispose waste according to the local regulations.
Roche Diagnostics
60 Notices
Magazine drawer (e 801 and e 602 module)
Excessive weight on magazine drawer Excessive weight on the magazine drawer of the
immunology test modules may lead to damage.
r Do not open the front door of the magazine drawer and
do not pull out the magazine drawer when the green
status lamp is off or blinking.
r Pull out the magazine drawer gently and do not lean on
the magazine drawer.
Preparation table (c 502 module)
Excessive weight on preparation table Excessive weight on the preparation table of the c 502
module may lead to damage. The maximum load of the
preparation table is 2 kg.
r Do not place anything other than reagent cassettes
upon the preparation table.
r Leave the preparation table closed, except when
registering reagent cassettes or when manually
unloading reagent cassettes from Reagent > Setting.
Transfer mechanism (c 702 module)
Excessive weight on transfer mechanism Excessive weight on the transfer mechanism for reagent
cassettes may lead to damage.
r Do not lean on the transfer mechanism.
1 Safety guide
Roche Diagnostics
Product safety labels 61
Product safety labels

Product safety labels indicate areas of potential hazards.
Familiarize yourself with the meaning of the product safety

labels.
In this section
List of product safety labels (61)
Product safety labels on the core unit (63)
Product safety labels on the ISE module (65)
Product safety labels on the c 702 module (68)
Product safety labels on the e 801 module (80)
Product safety labels on the e 602 module (89)
List of product safety labels

Product safety labels are placed on the instrument to draw
your attention to areas of potential hazard. Listed below
are labels and the definitions according to the location on
the instrument.
The product safety labels comply with the following

standards: ANSI Z535, IEC 61010-2-101, IEC 61010-1,
IEC 60417, ISO 7000, or ISO 15223-1.
q Only Roche Service representatives are allowed to

replace damaged labels. For replacement labels, contact
Spillage
Spillage near this label may damage the instrument.
Do not place liquids in this area.
1 Safety guide
Infection
Touching the system mechanism may cause infection.
Do not open the covers while the system is in operation.
Stop every mechanism before opening a cover.
Roche Diagnostics
62 Product safety labels
Skin inflammation or injury

Direct contact with reagents, wash solutions, or other
working solutions may cause skin irritation, inflammation,
or burns.
o When you handle reagents, exercise the precautions
required for handling laboratory reagents.
o Wear appropriate personal protective equipment.
o Observe the instructions given in the Instructions for
Use.
General warning
Potential hazards located near this label may lead to
death or serious injury.
Refer to the user documentation for instructions on safe
operation.
Biohazard
Potentially biohazardous materials are used near this
label.
Observe relevant Good Laboratory Practices on safe
usage.
Always switch off the system or go to maintenance mode,
if available, before you work with an opened cover (for
example, for cleaning or maintenance).
Wear appropriate personal protective equipment.
Electrical
If you access parts marked with this label, contact with
electrical components may cause an electric shock.
Refer to the user documentation for instructions on safe
operation.
Flammable
The cooling unit of certain c 701, c 702, and e 801
modules contains flammable refrigerant. The
corresponding module can be identified by a Risk of Fire
safety label. Do not remove any cover of the system
except those specified in the instructions. Leave
maintenance, installation, or service that is not described
to trained Roche Service representatives.
Hot surface
1 Safety guide
The area near this label may be hot.

To avoid burns, do not touch this area.
Moving parts
Contact with moving parts located near this label may
lead to injuries.
Keep your hands away from moving parts.
Roche Diagnostics
Sharp objects
Contact with sharp objects located near this label may
lead to injuries.
Keep your hands away from this area.
Maximum load
Overloading may damage the preparation table of the
c 502 module.
o Do not place anything other than reagent cassettes
2 kg Max.
upon the preparation table.
The safety messages give more detailed information about

potentially hazardous situations that may arise during daily
operation, or when carrying out maintenance actions.
When working with the instrument, observe both the

product safety labels and the safety messages in the user
documentation.
Product safety labels on the core unit
1 Safety guide
A Core unit
w Core unit
Roche Diagnostics
w Rear view of the core unit
u Related topics
• List of product safety labels (61)
• About the laser barcode reader (94)
1 Safety guide
Roche Diagnostics
Product safety labels on the ISE module
A Covers of ISE measuring compartments
w Top view of the ISE module
Covers of ISE measuring compartments Opening the covers of the ISE measuring compartments
during analysis may lower measurement accuracy.
• Keep the covers closed during analysis.
Remaining liquid inside an ISE measuring compartment may

lower measurement accuracy.
• After maintenance, wipe up any liquid inside the ISE
measuring compartments.
1 Safety guide
Roche Diagnostics
A Top cover C Drain ports

B Syringes
w Front view of the ISE module
Top cover Opening the top cover triggers the safety interlock and
interrupts operation. All pipetted samples are lost and
must be reloaded.
• Do not open the top cover during operation.
Syringes Moving syringe plungers may pinch your fingers or skin.

• Do not touch any moving parts.
Drain ports Touching the drain ports during analysis may lower
measurement accuracy.
• Keep the front door closed during operation.
1 Safety guide
Roche Diagnostics
w Rear view of the ISE module
u Related topics
1 Safety guide
Roche Diagnostics
Product safety labels on the c 702 module
A Transfer mechanism
w Top view of the c 702 module
Transfer mechanism Overloading may damage the transfer mechanism.

• Do not lean on the transfer mechanism.
1 Safety guide
Roche Diagnostics
w Reagent manager of the c 702 module
1 Safety guide
A Syringes
w Front view of the c 702 module

Roche Diagnostics
Loose syringe connectors may lower measurement

accuracy.
• After performing maintenance, tighten the syringe
connectors securely.
A Plexiglass cover
w Rear view of the c 702 module
Plexiglass cover Opening the plexiglass cover triggers the safety interlock
and interrupts operation. All pipetted samples are lost and
must be reloaded.
• Do not open the plexiglass cover during operation.
1 Safety guide
Roche Diagnostics
B
C
A Water inlet C Cooling unit

B Water container

1 Safety guide
Water inlet If the water inlet filter is clogged or the water tubing is not
connected properly, then incorrect results may occur.
• Follow all instructions for water inlet filter maintenance
carefully.
Water container Water may leak from the water container and may cause
damages.
• Before disconnecting the tubing connector, close the
stopcock at the water container.
Roche Diagnostics
Cooling unit Newer modules use a flammable refrigerant in the cooling

unit.
• Follow all safety instructions carefully.
u Related topics

1 Safety guide
Roche Diagnostics
w MSB of the c 701 module
A 1 Safety guide
A Syringes

Loose syringe connectors may lower measurement

accuracy.
Roche Diagnostics
A Plexiglass cover
Plexiglass cover Opening the plexiglass cover triggers the safety interlock
and interrupts operation. All pipetted samples are lost and
must be reloaded.
• Do not open the plexiglass cover during operation.
1 Safety guide
Roche Diagnostics
B
C

B Water container

1 Safety guide
carefully.
damages.
Roche Diagnostics

unit.
u Related topics
B 2 kg Max.
A Photometer lamp (below reaction disk) B EcoTergent and reagent pipetters
Photometer lamp (below reaction disk) Touching the hot photometer lamp or the lamp housing
may lead to burns.
• Wait until the photometer lamp has cooled down.
1 Safety guide
EcoTergent and reagent pipetters Moving pipetters may pinch your fingers.
Roche Diagnostics
w MSB of the c 502 module
C
1 Safety guide
A Top cover C Reagent cassette loading port

B Reagent cassette piercer
Top cover Opening the top cover triggers the safety interlock and
interrupts operation. All pipetted samples are lost and
must be reloaded.
• Do not open the top cover during operation.
Roche Diagnostics
Reagent cassette piercer Touching the sharp reagent cassette piercer may pinch
your fingers.
• Do not touch the reagent cassette piercer.
Reagent cassette loading port Reaching into the loading port may lead to injuries.
• Do not put your fingers into the loading port.
A Syringes B Syringe connectors

Syringe connectors Loose syringe connectors may lower measurement

accuracy.
1 Safety guide
Roche Diagnostics
A Water inlet B Water container
carefully.
damages.
u Related topics
1 Safety guide
Roche Diagnostics
Product safety labels on the e 801 module
A Table cover
w Top view of the e 801 module
Table cover Open and close the top cover carefully to avoid injuries.
Spillage on the table cover may damage the instrument.
• Do not let go the handle when opening or closing the
top cover.
• If the top cover does not stay open properly, contact
• Do not place liquids on the table cover.
1 Safety guide
Roche Diagnostics
w MSB of the e 801 module
1 Safety guide
A Reagent pipetters
w Reagent area of the e 801 module
Reagent pipetters Touching the reagent pipetters may lead to injuries.

• Do not touch the tip of a reagent pipetter.
Roche Diagnostics
A Sample pipetter
w Sampling area of the e 801 module
Sample pipetter Touching the sample pipetter may lead to injuries or

infection.
• Wear appropriate personal protective equipment.
1 Safety guide
Roche Diagnostics
w Inside the detection unit of the e 801 module
1 Safety guide
w Outside the detection unit of the e 801 module
Roche Diagnostics
w Pre-wash area of the e 801 module
A
1 Safety guide
A Top cover B Magazine drawer
w Front view of the e 801 module
Roche Diagnostics
Top cover Touching mechanical parts below the top cover may lead
to injuries or infection. The top cover is locked by the
safety interlock during operation.
• Keep the top cover closed whenever possible.
Magazine drawer Wrong handling of the magazine drawer may lead to

damages.
• Do not open the magazine drawer when the green
• When the green status lamp is on, pull out the magazine
drawer gently.
• Do not put excessive weights on the magazine drawer.
A
B
A PreClean II M bottles C ProCell II M and CleanCell M bottles

B Syringes
w Behind the front door of the e 801 module
PreClean II M bottles Wrong positioning of PreClean II M bottles or aspiration of

1 Safety guide
air may lead to incorrect results.

• Only change a PreClean II M bottle when the
corresponding green button is flashing.
• Before closing the front door, lower the aspiration
pipes into the bottles again.

Roche Diagnostics
ProCell II M and CleanCell M bottles Wrong positioning of system reagent bottles or aspiration
of air may lead to incorrect results.
• To avoid mixing up bottle positions, ensure that the
bottle stand is in place.
• Only change a system reagent bottle when the green
button is flashing or the onboard stability is expired.
w Magazine drawer of the e 801 module

1 Safety guide
Roche Diagnostics
B
C

B Water container
w Rear view of the e 801 module

1 Safety guide
carefully.
damages.
Roche Diagnostics

unit.
1 Safety guide
Roche Diagnostics
Product safety labels on the e 602 module
A Reagent disk cover B Incubator
w Top view of the e 602 module
Reagent disk cover Opening the reagent disk cover may lower measurement
accuracy.
• Keep the reagent disk cover closed during analysis.
Incubator Touching mechanical parts of the incubator may lead to

injuries.
• Return the incubator cover after performing
maintenance.
1 Safety guide
Roche Diagnostics
w MSB of the e 602 module
A B
1 Safety guide
A Top cover B Magazine drawer
w Front view of the e 602 module
Top cover Touching mechanical parts below the top cover may lead
to injuries or infection.
• Keep the top cover closed during operation.
• Always switch off the system or go to maintenance
mode, if available, before you open the top cover (for
example, for cleaning or maintenance).
Roche Diagnostics
Magazine drawer Wrong handling of the magazine drawer may lead to

damages.
• Do not open the magazine drawer when the green
• When the green status lamp is on, pull out the magazine
drawer gently.
• Do not put excessive weights on the magazine drawer.
A C
A PreClean bottle stand C ProCell M and CleanCell M bottles

B Syringes
w Behind the front door of the e 602 module
PreClean bottle stand Wrong positioning of PreClean M bottles or aspiration of air

may lead to incorrect results.
• Only change a PreClean M bottle when the
corresponding green button is flashing.
Touching the PreClean probes may lead to injuries.

1 Safety guide
• Do not put your fingers into the PreClean M bottle

stand.

Roche Diagnostics
ProCell M and CleanCell M bottles Wrong positioning of system reagent bottles or aspiration
of air may lead to incorrect results.
• To avoid mixing up bottle positions, ensure that the
bottle stand is in place.
• Only change a system reagent bottle when the green
button is flashing.
w Magazine drawer of the e 602 module

1 Safety guide
Roche Diagnostics
A Water inlet B Water container
w Rear view of the e 602 module
carefully.
damages.
1 Safety guide
Roche Diagnostics
94 Safety information for barcode readers
Safety information for barcode readers

The instrument uses barcode readers to scan the barcodes
on samples and racks.
• Most of the barcode readers use LED technology with
low output power.
• One laser barcode reader is used in the core unit. The
laser beam is fully covered during normal operation.
The instrument complies with the lowest laser class

(Class 1) as long as the laser barcode reader is covered.
However, you must observe the following safety message.
! CAUTION
Eye injury due to barcode reader
The barcode reader of the core unit contains a class 2
laser. Staring deliberately into the beam may injure your
eyes.
r Do not stare into the beam of a barcode reader.
r Do not remove covers from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in the operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.
In this section
About the laser barcode reader (94)
About the LED barcode readers (95)
About the laser barcode reader

The core unit uses a covered laser beam to identify the
barcode labels on tubes. The beam of the used class 2
laser is protected from possible viewing so that the core
1 Safety guide
unit itself is a class 1 product (which is the lowest class).
The mentioned classes refer to the standard IEC 60825-1:

• Class 1: Eye-safe under normal environmental
conditions.
• Class 2: Visible lasers. Eye-safe for accidental viewing.
However, it may not be safe for a person who
deliberately stares into the laser beam for longer than
0.25 s by overcoming their natural aversion response to
the bright light.
Roche Diagnostics
Safety information for barcode readers 95
The figure shows the position of the laser barcode reader

and the direction of its aperture.
Specification
Wavelength 660 nm
Pulse width 112 µs
Pulse frequency 8.93 kHz
Output power 1.0 mW
Max. output of laser diode 10 mW
Class 2 laser according to IEC 60825-1, +A2
y Laser barcode reader in the core unit
About the LED barcode readers

LED barcode readers (Class 1) scan the barcodes on racks
or reagent cassettes.
The figures show the position of the LED barcode readers

(Class 1) and the directions of their apertures.
Core unit and ISE module
Position Wavelength Output power

Core unit 655 nm 10 µW
ISE module 655 nm 10 µW
y LED barcode readers – Core unit and ISE module
c 701 module

MSB 655 nm 10 µW
1 Safety guide
Rack Transport 655 nm 10 µW

Line
y LED barcode readers – c 701 module
Roche Diagnostics
96 Safety information for barcode readers
c 702 module

MSB 655 nm 10 µW
Line
c 502 module

MSB 655 nm 10 µW
Line
Reagent loading 655 nm 10 µW
port
e 801 module

MSB 655 nm 10 µW
Line
y LED barcode readers – e 801 module
e 602 module

MSB 655 nm 10 µW
Line
Reagent disk 655 nm 102.92 µW
1 Safety guide
y LED barcode readers – e 602 module
Roche Diagnostics
Safety interlock 97
Safety interlock
Several covers of the instrument are equipped with a
safety interlock to protect you from being injured by fast
moving parts.
The instrument uses 2 different types of safety interlocks:

• Electronic safety interlock, used in various covers
• Mechanical safety interlock, used in top covers of
c 701, c 702 and e 801 modules
In this section
About electronic safety interlock for various covers (97)
Resuming operation after a stop by safety interlock (98)
About mechanical safety interlock of top cover on e 801,
c 702 and c 701 modules (99)
About electronic safety interlock for various covers

If you open an interlock cover, the safety interlock
immediately disconnects the power supply for all moving
parts below this cover.
! WARNING
Incorrect results may occur due to interruption of
operation
The safety interlock senses opening of the monitored
covers and immediately stops operation by cutting off the
power. All pipetted samples are lost and must be reloaded.
r Before starting operation or a software-controlled
maintenance action, be sure to close and lock all
covers. Operation will not start if an interlock cover is
open.
r Do not open an interlock cover during operation or
maintenance. Mask the module first to put it in Standby
mode.
1 Safety guide
The following covers are monitored by an electronic safety

interlock:
• ISE module: Top cover
• c 701/c 702 modules: Rear plexiglass cover around the
sample probes
• c 502 module: Top cover
Roche Diagnostics
98 Safety interlock
A B C
A ISE module: Top cover B c 701/c 702 module: Rear plexiglass C c 502 module: Top cover
cover
w Covers monitored by an electronic safety interlock
• If you open one of these covers during maintenance

(such as incubator bath cleaning), this status is
terminated. After closing the cover again, the status
changes to Standby.
• If you open one of these covers during operation, the
instrument performs an E.Stop. The monitor displays a
red alarm (Stop). To put the instrument back to Standby
mode to resume operation, perform the following
procedure.
Resuming operation after a stop by safety interlock

If you have triggered an E.Stop by safety interlock, you
must put the instrument to Standby mode before resuming
operation.
q Whenever it is possible that mechanisms have been

moved, execute a reset to return all mechanisms to their
home positions.
Always execute a reset after using the interlock release
tool (c 502 module).
r To resume operation after a stop by

1 Safety guide
safety interlock
1 Close and lock the cover that is monitored by the safety

interlock.
2 If an alarm about an unlocked cover is issued, delete

this alarm.
Roche Diagnostics
Safety interlock 99
3
3 Choose Utility > Maintenance > Maintenance.
4
4 Choose the (1) Reset option.
5 Choose the Select button.
6
6 Select the module to be reset.
7 Choose the Execute button.
About mechanical safety interlock of top cover on e 801,

c 702 and c 701 modules
The top covers of the e 801, c 702 and of the newer
c 701 modules are provided with a mechanical safety
interlock. When starting operation, the instrument
automatically locks the top cover if it is closed.
The mechanical safety interlock of the top cover is not

available on older c 701 modules. For more information,
contact your Roche Service representative.
A B C
1 Safety guide
A e 801 top cover B c 702 top cover C c 701 top cover
w Covers monitored by a mechanical safety interlock
Roche Diagnostics
100 Safety interlock
If the top cover is open at the beginning of operation, the

instrument cannot lock it and issues an alarm without
starting operation. In Standby mode, the reagent managers
of the e 801 and c 702 modules may only load a reagent
cassette if the top covers are closed.
! WARNING
Infection and injury when the top cover is open
(c 702 only)
Contact with the reagent cassette transfer mechanism or
other mechanisms of the c 702 module may result in
personal injury or infection. Therefore, the top cover is
locked when the transfer mechanism moves.
r Before opening the c 702 top cover while the module is
in Standby mode, check the Reagent Manager Overview
menu. Make sure that there are no reagent cassettes
inside the buffer rotor of the reagent manager.
r Keep the top cover closed whenever possible.
Otherwise, reagent cassettes cannot be loaded.
r Before starting operation or any software-controlled
maintenance, be sure to close the top cover of the
c 702 module. Otherwise operation will not start.
1 Safety guide
Roche Diagnostics
Safety information for disposal 101
Safety information for disposal

In this section
Disposal information (101)
Disposal information
Infection by an infectious instrument r Treat the instrument (core unit and analytical modules)
as infectious waste. Decontamination (the combination
of processes including cleaning, disinfection, and/or
sterilization) is required before reuse, recycling, or
disposal of the instrument.
r After decontamination, still treat the instrument as
potentially infectious as there might be a remaining risk.
r Dispose of the instrument according to the local
regulations. For more information, contact your Roche
Collection of fluorocarbons The cooling unit of the c 502, c 701, c 702, and e 801
modules contains fluorocarbons. In some countries,
fluorocarbons must be disposed of by designated
collection facilities.
r For the disposal of the cooling unit, refer to local
regulations and authorities.
Disposal of control unit components
Electronic equipment: This symbol appears on any

component of your control unit (such as the computer,
monitor, or keyboard) that is covered by the European
Directive on Waste Electrical and Electronic Equipment
(WEEE).
You must dispose of these items through designated
collection facilities appointed by government or local
1 Safety guide
authorities.
Refer to the PC manufacturer’s manual or contact your city
office or waste disposal service for more information about
disposal of your old product.
Constraint:
It is left to the responsible laboratory organization to
determine whether control unit components are
contaminated or not. If contaminated, treat them in the
same way as the instrument.
Roche Diagnostics
102
1 Safety guide Safety information for disposal
Roche Diagnostics
103
Table of contents
Overview of the system 2
In this chapter 2
About the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
About the data manager. . . . . . . . . . . . . . . . . . . . . . . . . 108
About the control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
About the core components . . . . . . . . . . . . . . . . . . . . . 111
About the core unit . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Top view of the core unit. . . . . . . . . . . . . . . . . . . 113
Front view of the core unit . . . . . . . . . . . . . . . . . 115
Rear view of the core unit. . . . . . . . . . . . . . . . . . 116
About module sample buffers . . . . . . . . . . . . . . . . . 117
Top view of the module sample buffer . . . . . . . 118
Rear view of the module sample buffer . . . . . . 119
About the cobas® ISE module . . . . . . . . . . . . . . . . . . . . 121
Top view of the ISE module. . . . . . . . . . . . . . . . . . . . 123
Sampling area of the ISE module. . . . . . . . . . . . 124
Measuring area of the ISE module. . . . . . . . . . . 125
Front view of the ISE module . . . . . . . . . . . . . . . . . . 127
Drain ports of the ISE module . . . . . . . . . . . . . . 128
Syringes of the ISE module . . . . . . . . . . . . . . . . 129
Reagent bottles of the ISE module . . . . . . . . . . 130
Rear view of the ISE module . . . . . . . . . . . . . . . . . . . 132
The Self-Contained ISE Support Box . . . . . . . . . . . 133
2 Overview of the system

About the cobas c 701 module . . . . . . . . . . . . . . . . . . . 134
Top view of the c 701 module . . . . . . . . . . . . . . . . . 135
Sampling area of the c 701 module . . . . . . . . . 136
Reagent area of the c 701 module . . . . . . . . . . 137
Reaction disk area of the c 701 module. . . . . . 138
Front view of the c 701 module . . . . . . . . . . . . . . . . 140
Maintenance and service controls of the c 701
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Syringes of the c 701 module . . . . . . . . . . . . . . 142
Cooling unit filter of the c 701 module. . . . . . . 143
Solenoid valve filter of the c 701 module . . . . 144
Vacuum system of the c 701 module . . . . . . . . 145
System reagent bottles of the c 701 module . 146
Rear view of the c 701 module . . . . . . . . . . . . . . . . 147
Reagent manager of the c 702 module . . . . . . 151
Roche Diagnostics
104
Table of contents

module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Cooling unit filter of the c 702 module. . . . . . . 162
Solenoid valve filter of the c 702 module . . . . 163
Reagent loading area of the c 502 module . . . 170
Maintenance push button of the c 502 module 177
Filters of the c 502 module . . . . . . . . . . . . . . . . 182
About the cobas e 801 module . . . . . . . . . . . . . . . . . . . 184
Top view of the e 801 module . . . . . . . . . . . . . . . . . 185
Consumables area of the e 801 module . . . . . 186
Reagent manager of the e 801 module . . . . . . 188
Reagent pipetters of the e 801 module . . . . . . 190
Sampling area of the e 801 module . . . . . . . . . 191
Pre-wash area of the e 801 module . . . . . . . . . 193
Detection unit of the e 801 module . . . . . . . . . 195
Front view of the e 801 module . . . . . . . . . . . . . . . . 197
Syringes of the e 801 module . . . . . . . . . . . . . . 198

System reagent bottles of the e 801 module . 200
Magazine drawer of the e 801 module . . . . . . . 201
Rear view of the e 801 module . . . . . . . . . . . . . . . . 203
About the cobas e 602 module . . . . . . . . . . . . . . . . . . . 205
Top view of the e 602 module . . . . . . . . . . . . . . . . . 206
Consumables area of the e 602 module . . . . . 207
Reagent area of the e 602 module . . . . . . . . . . 209
Sampling area of the e 602 module . . . . . . . . . 210
Pre-wash area of the e 602 module . . . . . . . . . 211
Measuring area of the e 602 module . . . . . . . . 213
Front view of the e 602 module . . . . . . . . . . . . . . . . 214
Syringes of the e 602 module . . . . . . . . . . . . . . 215
System reagent bottles of the e 602 module . 217
Magazine drawer of the e 602 module . . . . . . . 218
Rear view of the e 602 module . . . . . . . . . . . . . . . . 219
Roche Diagnostics
About the system 105
About the system

The cobas® 8000 modular analyzer series is a fully
automated, high throughput laboratory system for clinical
chemistry tests and immunology tests. The system is
designed for a large array of quantitative and qualitative in
vitro tests and can be operated 24 hours a day, 7 days a
week.
A B C
A Data manager C Core components and analytical modules

B Control unit D Instrument
w System (example configuration)
The system consists of the following components:

• Data manager
• Control unit
• Core components

• ISE module (optional)
• Up to 4 cobas c modules/cobas e modules
The core components link the analytical modules together.
The control unit, the core components, and the analytical

modules are referred to as the instrument.
Roche Diagnostics
106 About the system
A B C D E F E G E H
A Data manager D ISE module G e 801 module

B Control unit E Module sample buffer (MSB) H e 602 module
C Core unit F c 702 module
w System components (example configuration)
Each analytical module has its own module sample buffer

(MSB). The ISE module, however, shares an MSB with the
first cobas c module of the instrument.
Component group Component Function Selected features

Data manager Control center between the host, Processes orders and results
cobas® link, and the control unit QC data management
Access to cobas® link
Control unit Controls the instrument functions Guides through preparation for daily operation
Displays the status of the modules
Core components Core unit Loads/unloads racks Up to 200 racks/h
Capacity of input buffer: 60 racks
Capacity of output buffer: 60 racks
Tube rotation (optional)
MSB Buffers the racks before pipetting Each analytical module has its MSB
20 positions for racks

5 positions for auto QC racks
y System - components
Roche Diagnostics
About the system 107
Component group Component Function Selected features

Analytical modules ISE module + + -
Determines Na , K , and Cl ions Up to 900 tests/h (1 ISE unit)
Up to 1800 tests/h (2 ISE units)
c 701 module Photometric tests Up to 2000 tests/h
> 200 applications
> 200 applications
Automatic reagent loading
> 200 applications
e 801 module Immunology tests Up to 300 tests/h
200 applications, cobas e flow tests
e 602 module Immunology tests Up to 170 tests/h
100 applications
y System - components
u Related topics
• Overview of cobas® link (246)
• Specifications of the control unit (2012)
• Specifications of the core components (2013)
• Specifications of the ISE module (2015)
• Specifications of the cobas c modules (2017)
• Specifications of the cobas e modules (2020)
Roche Diagnostics
108 About the data manager
About the data manager

The data manager is the control center between the host,
cobas® link, and the instrument.
A B
A Data manager B User interface of the data manager (Sample overview menu)
The data manager has, for example, the following tasks:

• To transfer orders on samples from the host to the
control unit
• To transfer sample, calibration, and QC results from the
control unit to the host
• To display the orders and results
• To perform cobas e flow tests on the e 801 module
• To perform repeat, rerun, or reflex tests if necessary
• To archive sample, calibration, and QC results

• To display data alarms and instrument alarms of the
control unit
• To connect the instrument to cobas® link
(e.g., to download current application settings,
calibrator data, and QC material data from the Roche
remote service platform)
u Related topics
• About the system (105)
• About the control unit (109)
Roche Diagnostics
About the control unit 109
About the control unit

Through the control unit, you control the operation of the
instrument.
A B
A Control unit B User interface of the control unit (Overview menu)
The control unit is placed near the instrument. The power

outlet at the rear side of the core unit supplies power to
the control unit.
The user interface displays the following status

information:
• Instrument mode (e.g., Standby mode or Operation
mode)
• Status of the analytical modules

• Status of the connection to the data manager
• Status of the connection to the pre-analytical system (if
installed)
The control unit gives you control over all instrument

functions, for example:
• To prepare the instrument for daily operation
• To order tests and review the results
• To manage the reagent supply to the instrument
• To calibrate the tests
• To monitor the QC status of the tests
• To perform maintenance actions
Roche Diagnostics
110 About the control unit
u Related topics
• About the system (105)
• About the data manager (108)
• Overview of the user interface (223)
• Quick reference: Main workflow (257)
Roche Diagnostics
About the core components 111
About the core components

The core components of the instrument transport and
buffer racks.
The instrument has the following core components:

• Core unit
• Up to 4 module sample buffers
• Rack Transport Line
• Rack return line
C D
A B
A Core unit C Rack Transport Line

B Module sample buffer (MSB) D Rack return line

The core unit and the MSBs are linked through the rack
Transport Line and the rack return line at the back of the
instrument.
The racks are moved from the input buffer of the core unit
to the respective MSBs. The MSBs buffer the racks until
they are due for sample pipetting. Finally, the racks are
moved back to the output buffer of the core unit.
In this section
About the core unit (112)
About module sample buffers (117)
Roche Diagnostics
112 About the core components
About the core unit

The core unit is always on the left side of the instrument. At
the core unit, you load and unload sample racks, calibrator
racks, and QC racks.
The core unit controls and optimizes the rack movements

throughout the whole instrument.
At the front panel, you power the instrument on and off.

u Specifications of the core unit (2013)
A Core unit
In this section
Top view of the core unit (113)
Front view of the core unit (115)
Rear view of the core unit (116)
Roche Diagnostics
Top view of the core unit
D E F
B C
A Output buffer E Rack barcode reader (below)

B Status indicators (output buffer) F Tube rotation unit (below)
C Status indicators (input buffer) G Sample barcode reader (below)
D Top cover H Input buffer

Status indicators The status indicators indicate whether you can access a
lane of the input or output buffer.
• ON: Lane is accessible
• OFF: No access
Top cover The top cover protects samples from contamination. Do

not open the top cover if the status indicators are off.
Input buffer The input buffer has 2 lanes. Each lane can hold up to
30 racks (150 samples). Racks are inserted into the input
buffer on rack trays. A rack tray holds up to 15 racks. The
racks are transported towards the rear buffer of the
respective lane. As soon as a rack tray is empty, the status
indicator turns on. Then you can open the top cover and
replace the empty rack tray with a full rack tray.
Roche Diagnostics
Rack barcode reader The rack barcode reader scans the rack barcodes to
identify the racks. Samples (routine samples, STAT
samples, calibrators, or QC material) must be transported
on racks of the corresponding rack class. Each rack class
has its own color and ID range.
! Refer to the Safety Guide

u Undetected scanning errors
u Eye injury due to barcode reader
Tube rotation unit (optional) The tube rotation unit turns tubes on racks without
stabilizers to barcode reading position. Tube rotation
reduces the throughput of the core unit. If the tubes must
be rotated < 180°, the throughput is reduced from
200 racks/h to 160 racks/h. If the tubes must be rotated
> 180°, the throughput is reduced to 120 racks/h.
If the core unit does not have a tube rotation unit, make
sure that the barcode labels of all tubes are in barcode
reading position.
Sample barcode reader The sample barcode reader scans the barcode of each
tube. To avoid barcode read errors, make sure that the
barcode labels are clean, dry, and in clear print. When
fixing barcode labels on tubes, make sure that the barcode
image lies within the scan zone. Avoid tilted barcode labels
and tubes.

u Eye injury due to barcode reader
Output buffer The output buffer has 2 lanes. Each lane can hold up to
30 racks (150 samples). The output buffer buffers

processed racks until you remove them from the
instrument. You remove racks on rack trays. A rack tray
holds up to 15 racks.
u Related topics
• Specifications of the core unit (2013)
• Specifications of racks with and without
stabilizers (2025)
• List of racks without stabilizers (2028)
• Specifications of barcodes (2038)
• Specifications of scan zones for sample
barcodes (2040)
Roche Diagnostics
Front view of the core unit
B
F
C D
A Power-on button D Time switch

B Power-off button E Core load indicator
C Timer toggle switch F Front panel
Front panel The front panel protects the buttons and the time switch
from accidental operation.
Power-on button You use the power-on button to manually power on the
whole instrument. Alternatively, you may use the time
switch to automatically power on the instrument at a set
time.
Power-off button You use the power-off button to manually power off the
whole instrument. However, the cooling units of the

analytical modules remain under power.
Time switch The time switch is used to set a power-up time for each day
of the week.
Timer toggle switch The timer toggle switch is used to activate the time switch.
• ON: The instrument is powered on automatically at the
set time.
• OFF: The instrument must be powered on manually.
Core load indicator This indicator is used by Roche Service representatives

only.
Roche Diagnostics
u Related topics
• Specifications of the electrical power supply and
consumption (2007)
• Powering off the instrument (623)
• Setting the day and time on the time switch (657)
Rear view of the core unit
A B
A Power outlet C STAT port

B Power inlet D Circuit breaker
Power outlet The power outlet provides power to the control unit and to
the data manager.
STAT port At the STAT port, you can insert a STAT rack or a sample
rack directly into the rack Transport Line. Racks inserted at

the STAT port are processed with higher priority than
sample racks loaded at the input buffer.
If the instrument is connected to a pre-analytical system,

all sample racks are imported via the STAT port.
Roche Diagnostics
Circuit breaker The circuit breaker protects the module from internal
electrical shorts. For troubleshooting, Roche Service
representatives may advise you to use the circuit breaker
to switch off the core unit.
Power inlet The power inlet connects the module to the main power
supply.
u Related topics
consumption (2007)
About module sample buffers

The instrument has up to 4 module sample buffers (MSBs).
An MSB is attached to the left of each cobas c module and
of each cobas e module. The MSB nearest to the core unit
serves its analytical module as well as the ISE module.
A B
A MSB for c 702 module (with reagent manager) B Standard MSB
The MSBs receive racks from the core unit via the rack
Transport Line. The MSBs buffer the racks until they are
due for sample pipetting in one or more of the analytical
modules.
Each MSB has 20 positions for buffering racks. In addition,

each MSB has a temperature-controlled compartment with
5 positions for auto QC racks.
Roche Diagnostics
The MSBs can deliver racks to any module at any time.

After processing, the racks are moved to the output buffer
of the core unit via the rack return line at the back of the
instrument.
u Specifications of the module sample buffers (2014)
In this section
Top view of the module sample buffer (118)
Rear view of the module sample buffer (119)
Top view of the module sample buffer
A A
A Backup operation port B Reagent manager of the c 702 module
Backup operation port If the core unit is out of order, you can use Backup
Operation mode to continue operating the instrument. In
this case, you use the backup operation port to insert racks
manually.
q For access to the backup operation port of the c 702

MSB, you must remove the preparation table of the
reagent manager.
Reagent manager (only c 702 module) The reagent manager of the c 702 module is mounted on
top of the MSB and is used to load reagent cassettes into
the c 702 module.
Roche Diagnostics
u Related topics
• Specifications of the module sample buffers (2014)
• Operating the instrument in backup operating
mode (644)
• About the cobas c 702 module (149)
Rear view of the module sample buffer
C
D
E
F
A B
A Water level sensor assembly D Water inlet

B Water container E Circuit breaker
C Water trap tubing F Power inlet
Water level sensor assembly The water level sensor assembly controls the water level in

the water container.
Water container The water container buffers deionized water for peak
consumption times.
Water trap tubing The water trap tubing is used to drain water from the water
trap of the degasser. If the water trap is full, you must
empty it.
The water trap tubing is only present with the c 701 and
c 702 modules.
Water inlet The water inlet connects the module to the deionized
water supply.
to switch off the module including its cooling unit.
Roche Diagnostics
supply.
u Related topics
• Specifications of the module sample buffers (2014)
consumption (2007)
• Specifications of the deionized water supply and
consumption (2009)
Roche Diagnostics
About the cobas® ISE module 121
About the cobas® ISE module

The ISE module uses 3 ion-selective electrodes (ISE) and a
reference electrode to determine the concentration of the
following ions in diluted samples:
• Sodium (Na+)
• Potassium (K+)
• Chloride (Cl-)
The ISE module is available with 1 ISE unit (up to

900 tests/h) or 2 ISE units (up to 1800 tests/h).
In addition to the standard ISE module, an ISE support box

is also available. The ISE support box is used in conjunction
with the ISE module and is available for the cobas® 8000
modular analyzer series with a c 502 module and without a
c 702 module or c 701 module in the configuration.
u Specifications of the ISE module (2015)
u The Self-Contained ISE Support Box (133)
Roche Diagnostics
122 About the cobas® ISE module
A ISE module
In this section
Top view of the ISE module (123)
Front view of the ISE module (127)
Rear view of the ISE module (132)
The Self-Contained ISE Support Box (133)
Roche Diagnostics
Top view of the ISE module
A Sampling area B Measuring area
The areas are described in the order of the workflow.
In this section
Sampling area of the ISE module (124)
Measuring area of the ISE module (125)
Roche Diagnostics
Sampling area of the ISE module

The sample pipetter aspirates sample, calibrator, or QC
material from containers on the racks and dispenses the
material into the dilution vessels of the ISE units.
D
E
F G
A Sample pipetter E Sample Cleaner 1

B Sampling position F Dispensing position of ISE unit 2
C Rinse station G Dispensing position of ISE unit 1
D Sample Cleaner 2
Sampling position The rack processing line transports racks into the ISE
module until the first tube on the rack is in sampling
position. The sample pipetter aspirates sample. The rack is
moved on, one tube at a time, for each aspiration.
Sample pipetter The sample pipetter aspirates one of the following liquids
and dispenses it into the dilution vessel of an ISE unit:
• Sample
• ISE calibrator (e.g., ISE Standard Low)
• ISE QC material (e.g., PCCC 1, PCCC 2)
• SysClean solution (for cleaning the ISE flow path)
• Activator (for conditioning the ISE electrodes)
Dispensing positions At the dispensing positions, the dilution vessels receive the
sample from the sample pipetter.
Rinse station To prevent carryover, the sample probe is rinsed inside and
outside with deionized water before each aspiration.
Sample Cleaner 1 Sample Cleaner 1 is an alkaline wash solution used for

special washes of the sample probe. The remaining volume
is monitored with liquid level detection.
Roche Diagnostics
Sample Cleaner 2 Sample Cleaner 2 is an acidic wash solution used for

u Related topics
• Reagents of the ISE module (316)
• List of sample and reagent pipetting volumes of the ISE
module (2016)
Measuring area of the ISE module

The measuring area of the ISE module has 1 or 2 ISE units.
Each ISE unit has a temperature-controlled compartment
with 3 ion-selective electrodes and 1 reference electrode.
The voltage between each of the ion-selective electrodes
and the reference electrode is measured and used to
determine the concentration of Na+, K+, and Cl- ions in
diluted samples.
F G H

A
B C D
A Dilution vessel E ISE sipper nozzle

B ISE Internal Standard supply nozzle F ISE electrodes
C ISE Diluent supply nozzle G Pinch valve
D Vacuum nozzle H Reference electrode
Roche Diagnostics
Dilution vessel The dilution vessel holds the following liquids during the
measuring sequence:
• ISE Internal Standard: This solution is used before
measuring to clean the dilution vessel and to determine
the reference potential for each measurement.
• Diluted sample: An ultrasonic mixer attached to the
dilution vessel mixes the sample at a fixed ratio with ISE
Diluent. The diluted sample is aspirated into the ISE
electrodes and measured against ISE Reference
Electrolyte in the reference electrode.
ISE Internal Standard supply nozzle This nozzle dispenses ISE Internal Standard into the
dilution vessel. The respective ISE Internal Standard
syringe aspirates ISE Internal Standard from a bottle
behind the front door. ISE Internal Standard is heated to
35 °C ± 2 °C before dispensing.
ISE Diluent supply nozzle This nozzle dispenses ISE Diluent into the dilution vessel.
The respective ISE Diluent syringe aspirates ISE Diluent
from a bottle behind the front door. ISE Diluent is heated to
35 °C ± 2 °C before dispensing.
Vacuum nozzle The vacuum nozzle aspirates any remaining liquid (ISE
Internal Standard, diluted sample) from the dilution vessel.
The vacuum nozzle is operated by the vacuum system. The
liquid is drained into the liquid waste container at the back
of the ISE module.
ISE sipper nozzle This nozzle aspirates ISE Internal Standard or diluted
sample from the dilution vessel into the ISE electrodes. The
nozzle is operated by the respective sipper syringe.
ISE electrodes, reference electrode The diluted sample is aspirated from the dilution vessel into
the ISE electrodes. ISE Reference Electrolyte is aspirated
from the respective bottle behind the front door into the
reference electrode. The concentration of the Na+, K+, and

Cl- ions in the diluted sample is determined from the
potential difference between the ion-selective electrodes
and the reference electrode.
Pinch valve The pinch valve and the solenoid valve between the ISE
Reference Electrolyte bottle and the reference electrode
control the liquid flow through the electrodes.
Pinch valve Solenoid valve Effect

Open Closed The sipper syringe aspirates diluted sample from the dilution
vessel into the ISE electrodes.
Closed Open The sipper syringe aspirates ISE Reference Electrolyte from the
bottle into the reference electrode.
y Liquid flow control in ISE electrodes and reference electrode
Roche Diagnostics
u Related topics
• Syringes of the ISE module (129)
• Reagent bottles of the ISE module (130)
• About ISE technology (1893)
Front view of the ISE module
A Drain ports C Reagent bottles

B Syringes

In this section
Drain ports of the ISE module (128)
Syringes of the ISE module (129)
Reagent bottles of the ISE module (130)
Roche Diagnostics
Drain ports of the ISE module

The liquid waste from the ISE units is drained through the
respective drain ports into the liquid waste container
behind the ISE module.
A B
A Drain port of ISE unit 2 B Drain port of ISE unit 1
Drain ports Any liquid waste is drained through the drain ports:
• Dilution vessels: The vacuum system of the ISE module
drains ISE Internal Standard and the residue of the
diluted samples from the dilution vessels.
• Electrodes: The sipper syringes drain ISE Reference
Electrolyte from the reference electrodes and ISE
Internal Standard and diluted sample from the ISE
electrodes.
u Related topics
• Rear view of the ISE module (132)
Roche Diagnostics
Syringes of the ISE module

Syringes transport liquids. Each syringe aspirates and
dispenses a specific type of liquid.
A B C D E F G
A ISE Internal Standard syringe (IS-2)(1) E ISE Diluent syringe (DIL-1)

B ISE Diluent syringe (DIL-2) F Sipper syringe (SIP-1)
C Sipper syringe (SIP-2) G Sample syringe
D ISE Internal Standard syringe (IS-1)
(1) The number refers to the ISE unit of the syringe, for example, the ISE Internal Standard syringe (IS-2) dispenses ISE Internal Standard into the
dilution vessel of ISE unit 2.
Sample syringe The sample syringe aspirates and dispenses determined

volumes of sample, calibrator, and QC material through

the sample pipetter. A pressure sensor in the sample
pipetter provides clot detection. The material is dispensed
into the dilution vessels of the ISE units.
ISE Internal Standard syringes The ISE Internal Standard syringes aspirate ISE Internal
Standard from the respective reagent bottles and
dispense it through the ISE Internal Standard supply
nozzles into the dilution vessels of the ISE units. ISE
Internal Standard is used for cleaning dilution vessels and
for IS measurements before and after measuring the
diluted sample.
ISE Diluent syringes The ISE Diluent syringes aspirate ISE Diluent from the
respective reagent bottles and dispense it through the ISE
Diluent supply nozzles into the dilution vessels of the ISE
units. ISE Diluent is used to dilute samples at a fixed ratio.
Roche Diagnostics
Sipper syringes The sipper syringes aspirate diluted sample from the
respective dilution vessels into the ISE electrodes. After
the pinch valve has been closed, the sipper syringes
aspirate ISE Reference Electrolyte into the reference
electrodes.
u Related topics
• Sampling area of the ISE module (124)
• Measuring area of the ISE module (125)
• Reagent bottles of the ISE module (130)
Reagent bottles of the ISE module

The reagent bottles for the ISE module are stored in a
drawer behind the front door. Each ISE unit needs 3
reagent bottles.
A
D
B
E
C
F
A ISE Reference Electrolyte-2 bottle(1) D ISE Reference Electrolyte-1(1) bottle

B ISE Internal Standard-2 bottle E ISE Internal Standard-1 bottle
C ISE Diluent-2 bottle F ISE Diluent-1 bottle
(1) The number after the reagent name refers to the ISE unit the reagent bottle is connected to, for example, the ISE Internal Standard-2 bottle is
connected to ISE unit 2.
ISE Reference Electrolyte 2 bottles contain ISE Reference Electrolyte, one bottle for
each ISE unit. The sipper syringes aspirate the solution into
the reference electrode. ISE Reference Electrolyte is used
as reference electrolyte against ISE Internal Standard and
against the diluted samples. The vacuum system degasses
ISE Reference Electrolyte to ensure accurate measuring.
The ISE Reference Electrolyte bottles are placed in the
back of the drawer behind the ISE Internal Standard and
ISE Diluent bottles.
Roche Diagnostics
ISE Internal Standard 2 bottles contain ISE Internal Standard, one bottle for each
ISE unit. ISE Internal Standard contains predefined
concentrations of Na+, K+, and Cl- ions. The ISE Internal
Standard syringes aspirate the solution and dispense it
through the ISE Internal Standard supply nozzles into the
dilution vessels of the respective ISE units. ISE Internal
Standard is used for cleaning the dilution vessels and for
IS measurements before and after measuring the diluted
samples.
ISE Diluent 2 bottles contain ISE Diluent, one bottle for each ISE unit.
The ISE Diluent syringes aspirate the diluent and dispense
it through the ISE Diluent supply nozzles into the dilution
vessels of the respective ISE units. ISE Diluent is used for
diluting samples at a fixed ratio. The vacuum system
degasses ISE Diluent to ensure accurate measuring.
u Related topics
• Syringes of the ISE module (129)
Roche Diagnostics
Rear view of the ISE module
C
B
D
A Liquid level sensor assembly C Circuit breaker

B Liquid waste container D Power inlet
Liquid level sensor assembly The liquid level sensor assembly controls the liquid level in
the liquid waste container.
Liquid waste container The liquid waste container collects the concentrated liquid
waste from the ISE module. Concentrated liquid waste is
potentially infectious and must be treated according to the
local regulations.
electrical shorts. You can also use the circuit breaker to
switch off the module for manual maintenance actions.
supply.
u Related topics
Roche Diagnostics
The Self-Contained ISE Support Box
ISE support box The ISE support box is used in conjunction with the
ISE module and is available for the cobas® 8000 modular
analyzer series with a c 502 module and without a c 702
module or c 701 module in the configuration.
The ISE support box supplies temperature-controlled

incubation water (37 °C) and degassed water to the
adjacent ISE module. In addition the ISE support box
supplies a vacuum via a vacuum supply unit built into the
ISE support box.
Roche Diagnostics
134 About the cobas c 701 module
About the cobas c 701 module

The c 701 module is a fully automated, high throughput
photometric analyzer for a large array of quantitative and
qualitative in vitro tests.
u Specifications of the cobas c modules (2017)
A B
A Module sample buffer B c 701 module
In this section
Top view of the c 701 module (135)
Front view of the c 701 module (140)
Rear view of the c 701 module (147)
Roche Diagnostics
Top view of the c 701 module
A Sampling area (behind cover) C Reaction disk area

B Reagent area
In this section
Sampling area of the c 701 module (136)
Reagent area of the c 701 module (137)
Reaction disk area of the c 701 module (138)
Roche Diagnostics
Sampling area of the c 701 module

The sample pipetters aspirate sample, calibrator, or QC
material from containers on the racks and dispense the
material into reaction cells in the reaction disk area.
E
B
C D
A Sample pipetter B D Sample Cleaner 2

B Rinse station E Sample pipetter A
C Sample Cleaner 1 F Rinse station
w Rear view of the sampling area of the c 701 module (safety cover removed)
Sample pipetters The sample pipetters aspirate sample, calibrator, or QC

material into reaction cells in the reaction disk area. The
sample pipetters have liquid level detection and clot

detection. A sample is dispensed every 1.8 s. While
dispensing, the beveled tip of the sample probe touches
the bottom of the reaction cell to ensure a precise
dispense volume. The sample probes are spring-mounted
to avoid damage to the probes and to the reaction cells.
Rinse stations The sample probes are rinsed inside and outside with
deionized water each time after dispensing a sample. The
rinse stations are the home positions of the sample
pipetters.


Roche Diagnostics
u Related topics
• Specifications of the sampling system of cobas c
modules (2018)
Reagent area of the c 701 module

The reagent area has 2 reagent disks. Each reagent disk
has 35 cooled positions for reagent cassettes. Each
reagent disk has 2 reagent pipetters assigned to it. The
reagent pipetters aspirate reagents from the reagent
cassettes and dispense them into reaction cells in the
reaction disk area.
B
C I
J
D
E F G H
A R2/R3 reagent pipetter of disk A G Rinse station

B Rinse station H Reagent disk B
C RFID reader of disk A (below) I R2/R3 reagent pipetter of disk B
D R1 reagent pipetter of disk A J RFID reader of disk B (below)
E Reagent disk A K Rinse station
F Rinse station L R1 reagent pipetter of disk B
Reagent disks Each reagent disk has 35 cooled positions for reagent
cassettes. You load the reagent cassettes manually.
RFID readers Each reagent disk has an RFID reader in the reagent
storage cover. The RFID reader reads the RFID tags on the
reagent cassettes. The RFID tags contain information such
as the reagent cassette number and the lot number.
Roche Diagnostics
Reagent pipetters The reagent pipetters aspirate reagent from the reagent
cassettes and dispense the reagent into reaction cells in
the reaction disk area. Each reagent pipetter serves a
specific reagent disk (A or B) and specific reagent timings
(R1 or R2/R3). The reagent pipetters use liquid level
detection to check the reagent volume in the reagent
cassettes.
Rinse stations The reagent probes are rinsed inside and outside with
deionized water each time before aspirating and after
dispensing reagent. The rinse stations are the home
positions of the reagent pipetters.
u Related topics
• Specifications of the reagent system of cobas c
modules (2018)
Reaction disk area of the c 701 module

The reaction disk has 406 reaction cells. The sample
material and the reagents are dispensed into the reaction
cells. The solution in each reaction cell is mixed, incubated,
and measured. After measuring, the reaction cell rinse
units clean the reaction cells.
F G
A
A Reaction disk E Photometer lamp

B Reaction cells (segment) F Reaction cell rinse unit 3
C Incubation bath G Reaction cell rinse unit 2
D Ultrasonic mixer H Reaction cell rinse unit 1
Roche Diagnostics
Reaction disk The reaction disk has 406 reusable plastic reaction cells.
The reaction disk turns the reaction cells to the sample
pipetters, reagent pipetters, ultrasonic mixers, photometer
windows, and reaction cell rinse units.
Reaction cells The reaction disk holds 14 segments with 29 reaction cells
each. You must replace used segments regularly.
Incubation bath The reaction cells are immersed in an incubation bath to

maintain the reaction mixture at the required temperature
of 37 °C ± 0.1 °C. A liquid level sensor controls the water
level of the incubation bath and adds deionized water to
compensate for evaporation. An ECO-D reagent cassette
must be present in reagent disk B. The reagent probe adds
ECO-D to the incubation bath each time the water is
exchanged. ECO-D is an additive that minimizes the
formation of air bubbles which could interfere with the
photometer readings.
Ultrasonic mixers The 6 ultrasonic mixers around the incubation bath are
used for non-contact mixing of the reaction mixture in the
reaction cells.
Photometer lamp The light of the photometer lamp passes through a glass
window into the incubation bath. In the incubation bath, it
passes through the reaction cell and the reaction mixture.
Finally, the light passes through another glass window into
the photometer. The photometer measures the
absorbance of the reaction mixture 38 times per reaction
cell within 10 minutes. The instrument determines the
concentration of the analyte from the measurements and
the respective calibration curve.
Reaction cell rinse units After measuring, the reaction cell rinse units clean, rinse,
and dry the reaction cells. For cleaning, CellCln1 and
CellCln2 are used. For rinsing, deionized water is used.

After cleaning and rinsing, 3 cell blank measurements are
performed to verify the optical performance of the
reaction cell. If the result deviates significantly from the
previous cell blank measurement, the reaction cell is
disabled.
u Related topics
• Specifications of the reaction system of cobas c
modules (2019)
• Specifications of the photometric system of cobas c
modules (2019)
• About photometric measuring principles (1898)
Roche Diagnostics
Front view of the c 701 module
E
C
A Maintenance and service controls D Solenoid valve filter

B Syringes E Drain tubings of the vacuum system
C Cooling unit filter F System reagent bottles
In this section
module (141)
Syringes of the c 701 module (142)
Cooling unit filter of the c 701 module (143)
Solenoid valve filter of the c 701 module (144)
Vacuum system of the c 701 module (145)
System reagent bottles of the c 701 module (146)
Roche Diagnostics
Maintenance and service controls of the c 701 module

The maintenance and service controls indicate the internal
power supply of the module and support specific
maintenance and service actions.
C
A
A Power indicators C Push button F1

B Incubation bath drain tap D Push button F2
Power indicators The power indicators are for Roche Service

representatives only.
Incubation bath drain tap The incubation bath drain tap is used to drain water from
the incubation bath.
Push button F1 This push button is used for specific maintenance actions

only:
• To start refilling of the incubation bath
• To move the reaction cell rinse nozzles up and down to
check the position of the nozzle tips
Push button F2 This push button is for Roche Service representatives only.
u Related topics
• Replacing reaction cells and cleaning the incubation
bath of the c 701 and c 702 modules (919)
• Checking the sample and reagent probes of the c 701
and c 702 modules (960)
• Replacing nozzle tips on reaction cell rinse nozzles of
the c 701 and c 702 modules (949)
Roche Diagnostics
Syringes of the c 701 module

Each syringe is connected by tubing to 1 of the sample or
reagent probes. The syringes use positive displacement to
aspirate and to dispense sample material and reagents via
the corresponding probes.
A B C D E F
A Reagent syringe (disk A, R1) D Reagent syringe (disk B, R2/R3)

B Reagent syringe (disk A, R2/R3) E Sample syringe (sample pipetter A)
C Reagent syringe (disk B, R1) F Sample syringe (sample pipetter B)
Sample syringes The sample syringes aspirate determined pipetting

volumes from the sample tubes and dispense them into the
reaction cells.
Reagent syringes The reagent syringes aspirate determined reagent volumes

from the reagent cassettes and dispense them into the

reaction cells. Each syringe serves a specific reagent disk
(A or B) and specific reagent timings (R1 or R2/R3).
u Related topics
• Sampling area of the c 701 module (136)
• Reagent area of the c 701 module (137)
Roche Diagnostics
Cooling unit filter of the c 701 module

The cooling unit filter prevents dust from entering the
cooling unit. The cooling unit cools reagent cassettes in
the reagent disks and is involved in maintaining the
incubation bath at a constant temperature.
A Cooling unit filter
u Related topics
• Cleaning the filters behind the front doors of the c 701
Roche Diagnostics
Solenoid valve filter of the c 701 module

The solenoid valve filter prevents dust from entering the
unit when the valve opens up for air supply.
A B
A Filter sponge B Filter cover
u Related topics
• Cleaning the solenoid valve filter of the c 701 and
c 702 modules (940)
Roche Diagnostics
Vacuum system of the c 701 module

The vacuum system aspirates liquid waste from the
reaction cell rinse unit and the rinse stations of the sample
probes and reagent probes. The vacuum system is also
used to dispense deionized water for cell blank
measurements into the reaction cells.
A Drain tubings of the vacuum system
Drain tubings The drain tubings of the vacuum system are used to drain

condensation water or liquid waste from the vacuum
system.
u Related topics
• Draining the vacuum tank of the c 701 and c 702
modules (953)
Roche Diagnostics
System reagent bottles of the c 701 module

The reaction cell rinse units use system reagents to clean
the reaction cells after measuring.
A B
A CellCln1 B CellCln2
CellCln1 CellCln1 is an alkaline wash solution for reaction cells

(NaOH-D).
CellCln2 CellCln2 is an acidic wash solution for reaction cells.
Roche Diagnostics
Rear view of the c 701 module
E
F
G
H
A B C D
A Outlet for diluted waste E Water trap tubing

B Outlet for highly concentrated waste F Water inlet
C Water level sensor assembly G Circuit breaker
D Water container H Power inlet

Outlet for diluted waste This outlet drains diluted waste from the module.
Outlet for highly concentrated waste This outlet drains highly concentrated waste from the
module. Highly concentrated waste is potentially
infectious and must be treated according to the local
regulations.
consumption times.
empty it.
water supply.
Roche Diagnostics
supply.
Roche Diagnostics

The c 702 module is a fully automated, high throughput
photometric analyzer for a large array of quantitative and
qualitative in vitro tests.
The reagent manager is the only difference to the c 701

module.
B C
A Reagent manager C c 702 module

B Module sample buffer
In this section

Roche Diagnostics
A B
A Reagent manager C Reagent area

B Sampling area (behind) D Reaction disk area
In this section
Reagent manager of the c 702 module (151)
Roche Diagnostics
Reagent manager of the c 702 module

The reagent manager loads reagent cassettes into the
reagent disks. The reagent cassettes are either moved
directly from the loading port to the reagent disks or are
stored intermediately in a buffer. A cap opener removes
the caps of the reagent cassettes before they are
transported to the reagent disks. When unloading, the
reagent manager transports the reagent cassettes from
the reagent disks to the unloading tray.
H I
B
C
D
J
E F G

A Control panel F Backup operation port
B Return port G Unloading tray
C Loading port H Control tower
D Cap waste box I Transfer mechanism
E Preparation table J Flap door
Control tower The control tower has a loading port for feeding reagent
cassettes into the reagent manager. An RFID reader reads
the RFID tags on the reagent cassettes. Invalid reagent
cassettes are ejected at the return port. The other reagent
cassettes are either moved directly to the reagent disks or
stored intermediately in a buffer inside the control tower.
At the control panel, you determine the loading mode
(direct or buffer) and the target reagent disk (A or B) for
the reagent cassettes. Before loading, a cap opener in the
control tower removes the caps of the reagent cassettes.
The caps are collected in the cap waste box.
Roche Diagnostics
Loading port
The preparation table in front of the loading port can hold

A B C D
up to 7 reagent cassettes. The green loading indicator
indicates whether you can load reagent cassettes.
On You can load reagent cassettes.
Off You cannot load reagent cassettes.
Blinking You must turn the reagent cassette in

the loading port so that the label with
the test name faces towards the left.
If the loading indicator is on and you place a reagent

cassette into the loading port, the shutter is opened and
the reagent cassette is drawn into the control tower. If the
buffer inside the control tower is full, the loading indicator
A Shutter C Loading indicator
turns off. The buffer has 10 positions for reagent
B Loading port D Preparation table
cassettes.
Control panel
At the control panel, you determine how the reagent

E
cassettes are loaded.
A To load a reagent cassette directly into

reagent disk A
B To load a reagent cassette directly into

reagent disk B
AUTO To load a reagent cassette directly. The

instrument determines the target
reagent disk.
BUFFER To load a reagent cassette into the

A BC D buffer. The instrument determines the
target reagent disk and the loading time.
A Disk A button D Disk B button

B AUTO button E BUFFER button The selection remains active until you press another push
C Calibration indicator button.
If the yellow calibration indicator is on, a reagent cassette

in the buffer must be calibrated. Information on the
respective reagent cassette is displayed in the Reagent
Manager Overview dialog box.
Roche Diagnostics
Return port
The reagent manager ejects invalid reagent cassettes at

A B C
the return port. The yellow status indicator indicates
whether a reagent cassette has been ejected.
On A reagent cassette has been ejected.
Off The return port is empty.
Reagent cassettes are ejected for various reasons, for

example:
• RFID tag is unreadable
• Reagent cassette is expired
• Reagent cassette is part of a set. Sets must be loaded
together in 1 loading session.
A Status indicator (return) C Return port • Foam detected
B Transparent cover • Unknown application
You can also eject reagent cassettes manually via the

control unit.
To remove a reagent cassette from the return port, you

must open the transparent cover.
Cap waste box The cap waste box collects the reagent caps removed by
the cap opener inside the control tower. Never reuse a
reagent cap from the cap waste box. Reused caps may
come off accidentally and get stuck in the cap opener or
may contaminate other reagents. The cap waste box can
hold up to 100 caps. If the cap waste box is 80% full, a
yellow alarm is issued. If the cap waste box is full, a red
alarm is issued and the module stops.
Transfer mechanism The reagent cassette gripper of the transfer mechanism

transports reagent cassettes from the control tower to the
reagent disks and from the reagent disks to the unloading
tray.
q If the instrument stops during operation, you may

need to move the gripper arm to the leftmost or rightmost
position by hand before executing a reset. Otherwise, the
module will not resume operation and an alarm will be
issued.
Flap door Each reagent disk has a flap door. The flap door opens
automatically to allow the reagent cassette gripper to
insert or remove reagent cassettes.
Roche Diagnostics
Unloading tray
C D The unloading tray receives reagent cassettes that must

be unloaded. The unloading tray has 2 lanes with a total
capacity of 12 reagent cassettes. The left lane
accommodates only empty reagent cassettes. The right
lane accommodates either empty reagent cassettes or
reagent cassettes that still contain reagent.
The yellow reagent indicator indicates whether the reagent

cassettes in the right lane contain reagent.
On The right lane holds reagent cassettes

with reagent.
Off The right lane holds only empty reagent

cassettes.
A B
The green access indicator indicates whether you can
A Access indicator C Unloading tray access the unloading tray.
B Reagent indicator D Hatch door
On You can access the unloading tray.
Off You cannot access the unloading tray.
After opening the hatch door, you must pull the unloading
tray all the way out to reset the counter for reagent
cassettes on the unloading tray.
Backup operation port
The backup operation port is located below the

preparation table. If the core unit is out of order, you can
use the backup operation port to insert racks manually. To
access the backup operation port, you must unfasten the
retaining thumb screw and remove the preparation table.
u Related topics
• Loading reagent cassettes on the c 702 module (349)
• Unloading reagent cassettes from the c 702 module
unloading tray (353)
• Emptying the cap waste box of the c 702 module (361)
A B C mode (644)
A Preparation table C Backup operation port

B Thumb screw
Roche Diagnostics

The sample pipetters aspirate sample, calibrator, or QC
material into reaction cells in the reaction disk area.
E
B
C D
A Sample pipetter B D Sample Cleaner 2

B Rinse station E Sample pipetter A
C Sample Cleaner 1 F Rinse station
w Rear view of the sampling area of the c 702 module (safety cover removed)
Sample pipetters The sample pipetters aspirate sample, calibrator, or QC

material into reaction cells in the reaction disk area. The

sample pipetters have liquid level detection and clot
detection. A sample is dispensed every 1.8 s. While
dispense volume. The sample probes are spring-mounted
to avoid damage to the probes and to the reaction cells.
Rinse stations The sample probes are rinsed inside and outside with
deionized water each time after dispensing a sample. The
rinse stations are the home positions of the sample
pipetters.


Roche Diagnostics
u Related topics
modules (2018)

The reagent area has 2 reagent disks. Each reagent disk
has 35 cooled positions for reagent cassettes. Each
reagent disk has 2 reagent pipetters assigned to it. The
reagent pipetters aspirate reagents from the reagent
cassettes and dispense them into reaction cells in the
reaction disk area.
D E F G
B C
A Rinse stations E R2/R3 reagent pipetter of disk A

B Reagent disk A F R2/R3 reagent pipetter of disk B
C Reagent disk B G R1 reagent pipetter of disk B
D R1 reagent pipetter of disk A
Reagent disks Each reagent disk has 35 cooled positions for reagent
cassettes. The reagent manager loads the reagent
cassettes automatically.
Reagent pipetters The reagent pipetters aspirate reagent from the reagent
cassettes and dispense the reagent into reaction cells in
the reaction disk area. Each reagent pipetter serves a
specific reagent disk (A or B) and specific reagent timings
(R1 or R2/R3). The reagent pipetters use liquid level
detection to check the reagent volume in the reagent
cassettes.
Roche Diagnostics
u Related topics
modules (2018)

and measured. After measuring, the reaction cell rinse
units clean the reaction cells.
F G

E
A Reaction disk E Photometer lamp

B Reaction cells (segment) F Reaction cell rinse unit 3
C Incubation bath G Reaction cell rinse unit 2
D Ultrasonic mixer H Reaction cell rinse unit 1
pipetters, reagent pipetters, ultrasonic mixers, photometer
windows, and reaction cell rinse units.
Roche Diagnostics

compensate for evaporation. An ECO-D reagent cassette
must be present in reagent disk B. The reagent probe adds
ECO-D to the incubation bath each time the water is
exchanged. ECO-D is an additive that minimizes the
Ultrasonic mixers The 6 ultrasonic mixers around the incubation bath are
used for non-contact mixing of the reaction mixture in the
reaction cells.
Reaction cell rinse units After measuring, the reaction cell rinse units clean, rinse,
and dry the reaction cells. For cleaning, CellCln1 and
disabled.
u Related topics

modules (2019)
modules (2019)
Roche Diagnostics
E
C
A Maintenance and service controls D Solenoid valve filter

B Syringes E Drain tubings of the vacuum system
C Cooling unit filter F System reagent bottles
In this section
module (160)
Cooling unit filter of the c 702 module (162)
Solenoid valve filter of the c 702 module (163)
Roche Diagnostics
Maintenance and service controls of the c 702 module

The maintenance and service controls indicate the internal
power supply of the module and support specific
maintenance and service actions.
C
A
A Power indicators C Push button F1

B Incubation bath drain tap D Push button F2
Power indicators The power indicators are for Roche Service

representatives only.
Push button F1 This push button is used for specific maintenance actions
only:
• To start refilling of the incubation bath
• To move the reaction cell rinse nozzles up and down to
check the position of the nozzle tips
Push button F2 This push button is for Roche Service representatives only.
u Related topics
• Replacing nozzle tips on reaction cell rinse nozzles of
Roche Diagnostics

Each syringe is connected by tubing to 1 of the sample or
reagent probes. The syringes use positive displacement to
aspirate and to dispense sample material and reagents via
the corresponding probes.
A B C D E F
A Reagent syringe (disk A, R1) D Reagent syringe (disk B, R2/R3)

B Reagent syringe (disk A, R2/R3) E Sample syringe (sample pipetter A)
C Reagent syringe (disk B, R1) F Sample syringe (sample pipetter B)
Sample syringes The sample syringes aspirate determined pipetting

volumes from the sample tubes and dispense them into the
reaction cells.

reaction cells. Each syringe serves a specific reagent disk
(A or B) and specific reagent timings (R1 or R2/R3).
u Related topics
Roche Diagnostics
Cooling unit filter of the c 702 module

The cooling unit filter prevents dust from entering the
cooling unit. The cooling unit cools reagent cassettes in
the reagent disks and is involved in maintaining the
incubation bath at a constant temperature.
u Related topics
Roche Diagnostics
Solenoid valve filter of the c 702 module

The solenoid valve filter prevents dust from entering the
unit when the valve opens up for air supply.
A B
A Filter sponge B Filter cover
u Related topics
• Cleaning the solenoid valve filter of the c 701 and
c 702 modules (940)
Roche Diagnostics

A Drain tubings of the vacuum system
Drain tubings The drain tubings of the vacuum system are used to drain

system.
u Related topics
• Draining the vacuum tank of the c 701 and c 702
modules (953)
Roche Diagnostics

The reaction cell rinse units use system reagents to clean
A B

(NaOH-D).

Roche Diagnostics
E
F
G
H
AB C D


regulations.
consumption times.
empty it.
water supply.
Roche Diagnostics
supply.
Roche Diagnostics

The c 502 module is a fully automated, photometric
analyzer for a large array of quantitative and qualitative in
vitro tests.
A B
A Module sample buffer B c 502 module

In this section
Roche Diagnostics
A Sampling area D Reagent loading area

B Reaction disk area E Maintenance push button
C Reagent area
In this section
Reagent loading area of the c 502 module (170)
Maintenance push button of the c 502 module (177)
Roche Diagnostics
Reagent loading area of the c 502 module

You insert the reagent cassettes at the loading port. The
reagent cassettes are drawn into the reagent preparation
station and registered there by the barcode reader. The
reagent cassette piercer punctures the reagent bottle
caps and the reagent cassette gripper transports the
reagent cassettes to the reagent disk. If a reagent
cassette must be unloaded while not yet empty (e.g.,
because there is foam), it is unloaded via the loading port.
If a reagent cassette is empty, the reagent cassette
gripper dumps it into the disposal shaft at the reagent
preparation station. You remove the empty reagent
cassettes at the disposal port behind the front door.
E F
A B C D
A Reagent preparation station D Disposal port (behind front door)

B Loading port E Reagent cassette piercer and reagent cassette gripper
C Preparation table (lowered) F Flap door
Preparation table You must lower the preparation table to gain access to the
loading port. On the preparation table, you can deposit the
reagent cassettes you want to load.
Roche Diagnostics
Loading port
At the loading port, you feed the reagent cassettes 1 at a

time into the module. The barcode label must face towards
the right.
If you choose to unload a reagent cassette from the

reagent disk in order to use it again later, the reagent
cassette is unloaded via the loading port.
Reagent preparation station The barcode reader of the reagent preparation station
reads the barcode label on the reagent cassette. If the
reagent cassette is valid, the instrument registers it. If the
reagent cassette is invalid, it is pushed back into the
loading port.
Reagent cassettes are rejected for various reasons, for

example:
• Barcode is facing the wrong way
• Barcode label is unreadable
• Reagent cassette is expired
• Instrument has previously discarded the reagent
cassette
Reagent cassette piercer The reagent cassette piercer is mounted on the

x-y-mechanism of the R1 reagent pipetter. The reagent
cassette piercer punctures the reagent bottle caps of the
reagent cassettes when they are registered for the first
time.

u Reagent cassette piercer (c 502 module)
Reagent cassette gripper The reagent cassette gripper is mounted on the

x-y-mechanism of the R1 reagent pipetter. When loading,
the reagent cassette gripper transports the reagent
cassettes from the reagent preparation station to the
reagent disk. When unloading, the reagent cassette
gripper transports the reagent cassettes from the reagent
disk to the top of the disposal shaft at the reagent
preparation station.
Flap door The reagent disk has a flap door. The flap door opens
automatically to allow the reagent cassette gripper to
insert or remove reagent cassettes. You must not manually
open the flap door.
Roche Diagnostics
Disposal port
The reagent cassette gripper dumps empty reagent

cassettes into the disposal shaft at the reagent
preparation station. The reagent cassettes slide down the
disposal shaft. The disposal shaft has a capacity of
10 reagent cassettes. You remove the reagent cassettes
at the disposal port behind the front door.
u Related topics
• Unloading reagent cassettes from the c 502
module (380)

material into a reaction cell in the reaction disk area.
C
D
E
A Sample pipetter D Sample Cleaner 2

B Shield pipe E Sample Cleaner 1
C Rinse station
Sample pipetter The sample pipetter aspirates sample, calibrator, or QC

material into a reaction cell in the reaction disk area. The
sample pipetter has liquid level detection and clot
detection. A sample is dispensed every 6 s. While
dispense volume. The sample probe is spring-mounted to
avoid damage to the probe and to the reaction cells.
Roche Diagnostics
Shield pipe The metal shield pipe protects the sample probe from
electrostatic noise during aspiration. Electrostatic noise
can interfere with the sensitive capacitance measurement
performed for liquid level detection.
Rinse station The sample probe is rinsed inside and outside with
dispensing a sample. The rinse station is the home position
of the sample pipetter.


u Related topics
modules (2018)
Roche Diagnostics

The reagent disk has 60 cooled positions for reagent
cassettes. The 2 reagent pipetters aspirate reagent from
the reagent cassettes and dispense the reagent into
reaction cells in the reaction disk area.
E F
B C D
A Reagent disk E R2 reagent pipetter

B Rinse station F R1 reagent pipetter
C Cutouts for R2 reagent pipetter G Cutouts for R1 reagent pipetter
D Rinse station
Reagent disk The reagent disk has 2 concentric rings in a temperature-

controlled compartment with a total of 60 positions for
reagent cassettes. The inner ring has 24 positions, the
outer ring has 36 positions.
Cutouts for reagent pipetters The cutouts in the compartment cover allow the reagent
pipetters to access the reagents.
Reagent pipetters The reagent pipetters are mounted on 2 independent

x-y-mechanisms. The reagent pipetters aspirate reagent
from the reagent cassettes and dispense the reagent into
reaction cells in the reaction disk area. Each reagent
pipetter serves specific reagent timings (R1 or R2/R3). The
R1 reagent pipetter has liquid level detection to check the
reagent volume of new reagent cassettes.
Roche Diagnostics
u Related topics
• Reagent loading area of the c 502 module (170)
modules (2018)

and measured. After measuring, the reaction cell rinse unit
cleans the reaction cells.
F G H I J

A B C D E
A ECO-D bottle F Reaction cell rinse unit

B Rinse station for EcoTergent pipetter G Reaction disk
C EcoTergent pipetter H Reaction cells (segment)
D Photometer lamp I Liquid level sensor
E Incubation bath J Ultrasonic mixers
w Reaction disk area of the c 502 module with and without reaction disk
pipetter, reagent pipetters, ultrasonic mixers, photometer
window, and reaction cell rinse unit.
Roche Diagnostics

compensate for evaporation.
ECO-D bottle ECO-D (EcoTergent) is an additive that minimizes the

EcoTergent pipetter The EcoTergent pipetter aspirates a determined volume

from the ECO-D bottle and dispenses it into the incubation
bath. ECO-D is added each time the water of the
incubation bath is exchanged.
Rinse station for EcoTergent pipetter At the rinse station, the EcoTergent pipetter is rinsed
inside and outside with deionized water each time after
dispensing ECO-D into the incubation bath.
Ultrasonic mixers The 3 ultrasonic mixers are used for non-contact mixing of
the reaction mixture in the reaction cells. Each ultrasonic
mixer is assigned to 1 of the 3 reagent timings R1, R2,
or R3.
Reaction cell rinse unit After measuring, the reaction cell rinse unit cleans, rinses,
and dries the reaction cells. For cleaning, CellCln1 and
disabled.
u Related topics
modules (2019)
modules (2019)
Roche Diagnostics
Maintenance push button of the c 502 module

The maintenance push button is used to move the pipetter
probes to predefined positions in order to check the
horizontal alignment of the probes. You must only use this
button if you have received special training in extended
maintenance actions that require the interlock release
tool.
A Maintenance push button
u Related topics
• Maintenance as required on the c 502 module (with
interlock release tool) (1027)
Roche Diagnostics
A Syringes C Drain tubing of vacuum system

B System reagent bottles D Filters
In this section
Filters of the c 502 module (182)
Roche Diagnostics

Each syringe is connected by tubing to one of the sample
or reagent probes. The syringes use positive displacement
to aspirate and to dispense sample material, reagents, and
EcoTergent via the corresponding probes.
A B C D
A Sample syringe C R2/R3 reagent syringe

B R1 reagent syringe D EcoTergent syringe
Sample syringe The sample syringe aspirates determined pipetting

volumes from the sample tubes and dispenses them into
the reaction cells.

reaction cells. Each syringe serves specific reagent timings
(R1 or R2/R3).
EcoTergent syringe The EcoTergent syringe aspirates a determined volume

from the ECO-D bottle and dispenses it into the incubation
bath.
u Related topics
• Reaction disk area of the c 502 module (175)
Roche Diagnostics

The reaction cell rinse unit uses system reagents to clean
A B

(NaOH-D).

Roche Diagnostics

A Drain tubing of vacuum system
Drain tubing The drain tubing of the vacuum system is used to drain

system.
u Related topics
• Draining the vacuum tank of the c 502 module (1020)
Roche Diagnostics
Filters of the c 502 module

The filters are used to prevent dust from entering the unit.
The filters must be cleaned regularly.
A B C
A Filter of circuit board rack C Cooling unit filter

B Power supply filter
u Related topics
module (1007)
Roche Diagnostics
G
H
A BC D E
A Incubation bath drain tap E Water container

B Outlet for diluted waste F Water inlet
C Outlet for highly concentrated waste G Circuit breaker
D Water level sensor assembly H Power inlet

regulations.
consumption times.
water supply.
supply.
Roche Diagnostics
184 About the cobas e 801 module
About the cobas e 801 module

The e 801 module is a fully automated, high throughput
immunology analyzer for a large array of quantitative and
qualitative in vitro tests including cobas e flow tests.
u Specifications of the cobas e modules (2020)
A B
A Module sample buffer B e 801 module

In this section
Top view of the e 801 module (185)
Front view of the e 801 module (197)
Rear view of the e 801 module (203)
Roche Diagnostics
About the cobas e 801 module 185
Top view of the e 801 module
A B C D E F
A Reagent manager D Detection unit with sipper station

B Reagent pipetters (covered) E Sampling area
C Pre-wash area (hidden) F Consumables area
In this section
Consumables area of the e 801 module (186)

Reagent manager of the e 801 module (188)
Reagent pipetters of the e 801 module (190)
Sampling area of the e 801 module (191)
Pre-wash area of the e 801 module (193)
Detection unit of the e 801 module (195)
Roche Diagnostics
Consumables area of the e 801 module

The magazine gripper supplies AssayCups to the incubator
disk and AssayTips to the sample pipetter. The used
AssayTips and AssayCups are disposed of into the
respective disposal openings.
D E F G
A B C
A Magazine gripper E Vortex mixer

B Magazine F AssayTip disposal openings

C AssayCup disposal openings G AssayTip buffer station
D Incubator disk
Magazine gripper The magazine gripper transports AssayCups and

AssayTips:
• AssayCups from the magazine to the incubator disk
• AssayTips from the magazine to the AssayTip buffer
station
• AssayCups from the incubator disk to the vortex mixer
and back
• Used AssayCups from the incubator disk to the
AssayCup disposal openings
Magazine AssayCups and AssayTips come in magazines.
Roche Diagnostics
AssayCup disposal openings The magazine gripper disposes of used AssayCups into
1 of the 2 AssayCup disposal openings. Each opening is
connected to 1 of the 2 solid waste containers in the
magazine drawer.
Incubator disk The incubator disk has 94 positions for AssayCups. The
incubator is maintained at a temperature of 37 °C.
Vortex mixer The vortex mixer mixes the reaction mixture after the
microbeads were added.
AssayTip disposal openings The sample pipetter disposes of used AssayTips into 1 of
the 2 AssayTip disposal openings. Each opening is
magazine drawer.
AssayTip buffer station The magazine gripper inserts an AssayTip into the AssayTip
buffer station. The sample pipetter takes up the AssayTip.
u Related topics
• Sampling area of the e 801 module (191)
• Magazine drawer of the e 801 module (201)
• Replacing consumables and changing solid waste
boxes on the e 801 module (436)
Roche Diagnostics
Reagent manager of the e 801 module

The reagent manager loads and unloads the reagent
cassettes. You can operate the reagent manager in
Standby mode or Operation mode.
A B C D E F G H
A Status indicator E Cap pre-opener

B Loading port F Reagent loader
C Reagent storage (hidden) G Load button
D RFID reader (below and towards reagent loader) H Reset button
Load button The load button calls the reagent loader or sends it down.
The LED of the button indicates the position of the reagent
loader.
u Load button (409)
Reset button To keep the reagent’s exposure to room temperature

short, the reagent loader is programmed to move down
automatically after 120 s. By pressing the reset button,
you can extend the loading time for 2 more minutes.
u Loading time and reset button (410)
Loading ports To load a reagent cassette, you must push it through 1 of

the 5 loading ports into the reagent loader. To unload a
reagent cassette, you must pull it out of the reagent loader
and through the respective loading port.
Roche Diagnostics
Cap pre-opener When loading a reagent cassette, the cap pre-opener

opens the reagent bottle caps to soft-close position. When
unloading a reagent cassette, the cap pre-opener softly
closes the caps. Caps in soft-close position minimize
reagent evaporation.
Reagent loader The reagent loader transports reagent cassettes down to

the reagent storage level and back. Halfway down or up
the reagent loader pauses for the RFID readers to read the
RFID tags of the reagent cassettes.
Reagent storage
The reagent storage offers 48 positions for assay, diluent,

B C
and pretreatment reagent cassettes. The positions are on
the outer ring of the reagent disk. The reagent cassettes
are stored at 5 °C to 10 °C.
The reagent cassette shifter moves reagent cassettes

between the outer ring and a position on the inner ring:
• The 48 positions on the outer ring are used for reagent
storage, reagent pipetting, and RFID reading.
• The position on the inner ring is used for reagent
pipetting, for mixing and pipetting of microbeads, and
for loading and unloading reagent cassettes.
The cap opener opens the caps of the reagent bottles

before aspiration and closes them afterwards to minimize
A
evaporation.
A Position for reagent cassette
B Reagent cassette shifter
C Cap opener
RFID readers The RFID readers are mounted inside the reagent loader
shaft. For each slot in the reagent loader, there is 1 RFID

reader that reads the RFID tag on reagent cassettes. The
RFID tag contains the following information: The reagent
cassette name, lot number, expiry date, and reagent
container code (R.Pack ID).
Status indicators The 5 status indicators show the status of the reagent
cassettes in the respective loading port.
u List of status indicators and button statuses on the
e 801 module (411)
u Related topics
• Changing reagent cassettes on the e 801 module (403)
• List of status indicators and button statuses on the
e 801 module (411)
Roche Diagnostics
Reagent pipetters of the e 801 module

The reagent pipetters aspirate pretreatment reagent,
reagent, microbeads, and diluent from the reagent
cassettes and dispense them into AssayCups on the
incubator disk.
A B C D E F G
A Microbead mixer E Reagent probes rinse station

B Microbead mixer rinse station F Reagent pipetter 2
C Microbead mixing position G Reagent pipetter 1
D Reagent pipetting positions
Microbead mixer Before microbead aspiration, the microbead mixer mixes

the microbead suspension in the reagent cassettes to
ensure a homogeneous suspension.
Microbead mixing position The microbead mixer mixes the microbead suspension
through an opening in the reagent storage.
Microbead mixer rinse station After mixing, the microbead mixer rinse station rinses the
microbead mixer paddle with deionized water.
Reagent pipetters The reagent pipetters aspirate pretreatment reagent,

cassettes and dispense them into AssayCups on the
incubator disk.
Reagent pipetting positions The reagent pipetters aspirate reagents through the
openings in the reagent storage.
Roche Diagnostics
Reagent probes rinse station Before and after pipetting, the reagent probes are rinsed
with CleanCell M solution and deionized water.
u Related topics
Sampling area of the e 801 module

material into AssayCups on the incubator disk.
A B C

D E
A Dispensing position 1 D AssayTip disposal openings

B Dispensing position 2 E AssayTip buffer station
C Sample pipetter
AssayTip buffer station For each sample, the magazine gripper inserts a new
AssayTip into the AssayTip buffer station.
Sample pipetter The sample pipetter takes up the AssayTip from the
AssayTip buffer station. The sample pipetter aspirates
sample, calibrator, or QC material from containers on the
racks and dispenses the material into AssayCups on the
incubator disk. The sample pipetter has liquid level
detection and clot detection.
Roche Diagnostics
Dispensing positions At the dispensing positions, the AssayCups on the

incubator disk receive the sample from the sample
pipetter. Dispensing position 1 is used for regular sample
pipetting, diluted sample pipetting, and pretreated sample
pipetting. Dispensing position 2 is used for pretreated
sample aspiration.
magazine drawer.
u Related topics
• Consumables area of the e 801 module (186)
Roche Diagnostics
Pre-wash area of the e 801 module

Most tests demand a pre-wash of the reaction mixture
before measuring. During the pre-wash, serum
constituents that are not bound to microbeads are
removed from the reaction mixture.
D E F G H
A B C
A Separation stations E Pre-wash sipper nozzle

B Vortex mixers F Rinse station

C Pre-wash gripper G SysClean adapter
D PreClean supply nozzle H LFC tool
Pre-wash gripper The pre-wash gripper transports AssayCups:

• From the incubator disk to the separation stations
• From the separation stations to the vortex mixers
• From the vortex mixers to the incubator disk
Separation stations The permanent magnets of the 2 separation stations

capture the microbeads with the attached immune
complex in the AssayCups.
Pre-wash sipper nozzle The pre-wash sipper nozzle aspirates reaction mixture and
PreClean II M solution from the AssayCups in the
separation stations.
Roche Diagnostics
PreClean supply nozzle The PreClean supply nozzle supplies PreClean II M solution
to the AssayCups in the separation stations. PreClean II M
solution removes serum constituents that may influence
the measurement.
Rinse station The rinse station rinses the nozzles in the pre-wash area
with deionized water.
Vortex mixers After the pre-wash, a vortex mixer brings the microbeads
back into suspension.
SysClean adapter The SysClean adapter is used for cleaning the flow path of
the pre-wash sipper nozzle with SysClean solution.
LFC tool The LFC tool facilitates inserting the SysClean adapter into
its position.
u Related topics
• System reagent bottles of the e 801 module (200)
• Cleaning the ECL and pre-wash flow paths of the e 801
module (1080)
Roche Diagnostics
Detection unit of the e 801 module

The detection unit has 2 measuring channels. Each
channel has a sipper turntable, an ECL sipper nozzle, and a
measuring cell. Each sipper turntable holds an AssayCup, a
PC cup, and a CC cup. The ECL sipper nozzles aspirate
reaction mixture, ProCell II M solution, and CleanCell M
solution from the respective cups into the measuring cells.
D E F G H I

A ECL sipper nozzle F SysClean adapter
B Liquid level sensor G Rinse station
C Sipper turntable (channel 1) H AssayCup holder
D CC cup I Sipper turntable (channel 2)
E PC cup
Sipper turntables The sipper turntables are revolvable cup holders with a
rinse station. Each sipper turntable holds an AssayCup, a
PC cup, and a CC cup. The sipper turntables are moved up
and down to allow the ECL sipper nozzles to aspirate liquid
from the cups.
AssayCup holders The gripper of the sipper station transports AssayCups

from the incubator disk to the AssayCup holders of the
sipper turntables.
Liquid level sensors The liquid level sensors determine the liquid level of
ProCell II M and CleanCell M solution.
Roche Diagnostics
ECL sipper nozzles Each ECL sipper nozzle aspirates the following liquids:
• ProCell II M solution to prepare the measuring cell.
• Reaction mixture from the AssayCup in the AssayCup
holder.
• ProCell II M solution to wash the microbeads with the
attached immune complexes in the measuring cell
before measuring.
• CleanCell M solution and ProCell II M solution to rinse
the measuring cell after measuring.
• SysClean solution to clean the ECL flow paths.
PC cups The ECL sipper nozzles aspirate ProCell II M solution from

the PC cups. The PC cups are refilled from the ProCell II M
bottles behind the front door.
CC cups The ECL sipper nozzles aspirate CleanCell M solution from

the CC cups. The CC cups are refilled from the CleanCell M
SysClean adapters The SysClean adapters are used for cleaning the ECL flow
paths with SysClean solution.
Rinse stations After aspirating the reaction mixture, the outside of the
ECL sipper nozzle and the outside of the liquid level sensor
are rinsed with deionized water.
Measuring cells The measuring cells magnetically capture the microbeads

with the attached immune complex that is to be
determined. All other serum constituents and unbound
reagents in the measuring cells are washed away with
ProCell II M solution. A photomultiplier measures the light
signal that is emitted by the ruthenium marker on the
immune complex under the effect of an electrical field.
u Related topics

• Cleaning the ECL and pre-wash flow paths of the e 801
module (1080)
• About the ECL measuring principles (1906)
Roche Diagnostics
Front view of the e 801 module
B C
A System reagent bottles C Magazine drawer

B Syringes
In this section
Syringes of the e 801 module (198)
System reagent bottles of the e 801 module (200)

Magazine drawer of the e 801 module (201)
Roche Diagnostics
Syringes of the e 801 module

The syringes are connected to the respective probes and
nozzles. The syringes aspirate and dispense reagents,
sample, microbeads, reaction mixture, and system
reagents. The syringes are filled with degassed and
deionized water.
A B C D E F
A Pre-wash syringe D Sample syringe

B ProCell syringe E Reagent syringes
C CleanCell syringe F Sipper syringes
Pre-wash syringe The pre-wash syringe is used for the pre-wash sipper
nozzle and the PreClean supply nozzle of the pre-wash
area. The pre-wash sipper nozzle aspirates unbound
reaction mixture and PreClean II M solution from the
AssayCups in the separation stations. The PreClean supply
nozzle supplies PreClean II M solution from the
PreClean II M bottles to the AssayCups in the separation
stations.
ProCell syringe The ProCell syringe aspirates ProCell II M solution from the
ProCell II M bottles and dispenses the solution into the PC
cups at the sipper turntables of the sipper station.
CleanCell syringe The CleanCell syringe aspirates CleanCell M solution from

the CleanCell M bottles and dispenses the solution into the
reagent probes rinse station and the CC cups at the sipper
turntables.
Roche Diagnostics
Sample syringe The sample syringe is connected to the sample probe. The
sample probe aspirates sample, calibrator, or QC material
from containers on the racks and dispenses the material
into AssayCups on the incubator disk.
Reagent syringes The reagent syringes are connected to the reagent

probes. The reagent probes aspirate pretreatment
reagent, reagent, microbeads, and diluent from the
reagent cassettes and dispense them into AssayCups on
the incubator disk.
Sipper syringes The sipper syringes are connected to the ECL sipper
nozzles in the detection unit. The ECL sipper nozzles
aspirate the following liquids into the measuring cells:
• ProCell II M solution to prepare the measuring cell.
• Reaction mixture from the AssayCup in the AssayCup
holder.
• ProCell II M solution to wash the microbeads with the
before measuring.
• CleanCell M solution and ProCell II M solution to rinse
the measuring cell after measuring.
• SysClean solution to clean the ECL flow paths.
u Related topics
• Reagent pipetters of the e 801 module (190)
• Pre-wash area of the e 801 module (193)
• Detection unit of the e 801 module (195)
Roche Diagnostics
System reagent bottles of the e 801 module

The e 801 module holds 2 bottles of each system reagent
behind the front doors. For each system reagent, you can
replace one bottle without interrupting operation. To avoid
misplacing bottles, the positions for the ProCell II M,
CleanCell M, and PreClean II M bottles are keyed.
A B C
A PreClean II M bottles C CleanCell M bottles

B ProCell II M bottles
PreClean II M bottles PreClean II M solution is used to pre-wash the reaction

mixture. The pre-wash removes serum constituents that
may influence the measurement.
ProCell II M bottles ProCell II M solution is used to prepare the measuring cells.

ProCell II M solution is also used to wash away remaining
serum constituents and reagents other than microbeads
with attached immune complex from the measuring cells.
Each ProCell II M bottle has an RFID tag.
CleanCell M bottles CleanCell M solution is used to clean the measuring cells

after measuring and the reagent probes after pipetting.
u Related topics
• Changing system reagents on the e 801 module (428)
Roche Diagnostics
Magazine drawer of the e 801 module

The magazine drawer holds the magazines with the
disposable AssayCups and AssayTips. The drawer also
stores the resulting waste, that is, used AssayTips, used
AssayCups, and empty magazines.
A B C
A Magazine lifter C Button for right solid waste container

B Button for left solid waste container
Roche Diagnostics
D C
A B
A Solid waste containers D WasteLiner (1 per solid waste container)

B Magazine waste compartment
C Status indicator
Status indicator If the status indicator is on, you can open the magazine
drawer. If the status indicator is flashing or off, the drawer
is blocked.
Magazine lifter The magazine lifter holds up to 15 magazines. The

magazine gripper of the consumables area can access the

topmost magazine.
Solid waste containers The solid waste containers hold one WasteLiner each. The
2 compartments are used alternately to dispose of used
AssayTips and AssayCups.
WasteLiner A WasteLiner receives the used AssayTips and AssayCups

for subsequent disposal.
Magazine waste compartment Empty magazines are disposed of into the magazine waste
compartment.
u Related topics
Roche Diagnostics
Rear view of the e 801 module
F
G
A B C D
A Outlet for diluted waste E Water inlet

B Outlet for highly concentrated waste F Circuit breaker
C Water level sensor assembly G Power inlet
D Water container

regulations.
consumption times.
water supply.
Roche Diagnostics
supply.
u Related topics
consumption (2007)
consumption (2009)
• List of concentrated liquid waste volumes (2010)
Roche Diagnostics
About the cobas e 602 module

The e 602 module is a fully automated immunology
analyzer for a large array of quantitative and qualitative in
vitro tests.
u Specifications of the cobas e modules (2020)
A B
A Module sample buffer B e 602 module

In this section
Top view of the e 602 module (206)
Front view of the e 602 module (214)
Rear view of the e 602 module (219)
Roche Diagnostics
Top view of the e 602 module
D E
B C
A Reagent area D Pre-wash area

B Measuring area E Sampling area
C Consumables area

In this section
Consumables area of the e 602 module (207)
Reagent area of the e 602 module (209)
Sampling area of the e 602 module (210)
Pre-wash area of the e 602 module (211)
Measuring area of the e 602 module (213)
Roche Diagnostics
Consumables area of the e 602 module

The magazine gripper supplies AssayCups to the incubator
disk and AssayTips to the sample pipetter. The used
AssayTips and AssayCups are disposed of into the
respective disposal openings.
D E F G
B
C
A Magazine F AssayTip disposal openings

B Magazine drawer G AssayTip buffer station

C Status indicator H Vortex mixer
D Magazine gripper I AssayCup disposal openings
E Incubator disk
Magazine AssayCups and AssayTips come in magazines.
Magazine drawer The magazine drawer holds the magazines. The magazine
drawer also stores the empty magazines and the used
AssayCups and AssayTips for subsequent disposal.
Status indicator If the status indicator is on, you can open the magazine
drawer. If the status indicator is flashing or off, the drawer
is blocked.
Roche Diagnostics
Magazine gripper The magazine gripper transports AssayCups and

AssayTips:
• AssayCups from the magazine to the incubator disk
• AssayTips from the magazine to the AssayTip buffer
station
• AssayCups from the incubator disk to the vortex mixer
and back
• Used AssayCups from the incubator disk to the
AssayCup disposal openings
AssayTip buffer station The magazine gripper inserts an AssayTip into the AssayTip
buffer station. The sample pipetter takes up the AssayTip.
Incubator disk The incubator disk has 54 positions for AssayCups. The
incubator is maintained at a temperature of
37.0 °C ± 0.3 °C.
magazine drawer.
Vortex mixer The vortex mixer mixes the reaction mixture after the
microbeads were added.
AssayCup disposal openings The magazine gripper disposes of used AssayCups into
1 of the 2 AssayCup disposal openings. Each opening is
magazine drawer.
u Related topics
• Magazine drawer of the e 602 module (218)

Roche Diagnostics
Reagent area of the e 602 module

The reagent area has a temperature-controlled
compartment for reagent cassettes. The reagent pipetter
aspirates pretreatment reagent, reagent, microbeads, and
diluent from the reagent cassettes and dispenses them
C D E
G
B
H
A Reagent disk (open cover view) E Microbead mixer

B Barcode reader (below) F Reagent pipetter

C Cap opener G Reagent probe rinse station
D Microbead mixer rinse station H ProbeWash bottles
Reagent disk The reagent disk offers 25 positions for assay, diluent, and
pretreatment reagent cassettes.
Barcode reader The barcode reader reads the 2D matrix barcode on the
reagent cassettes.
Cap opener The cap opener opens the caps of the reagent cassettes
for the reagent pipetter and the microbead mixer. The cap
opener can be configured to close the caps after pipetting
or mixing to minimize evaporation.
Reagent pipetter The reagent pipetter aspirates pretreatment reagent,

cassettes and dispenses them into AssayCups on the
incubator disk.
Roche Diagnostics
Reagent probe rinse station After pipetting, the reagent probe rinse station rinses the
probe of the reagent pipetter with deionized water.
Microbead mixer Before microbead aspiration, the microbead mixer mixes

the microbead suspension in the reagent cassettes to
ensure a homogeneous suspension.
Microbead mixer rinse station After mixing, the microbead mixer rinse station rinses the
microbead mixer paddle with deionized water.
ProbeWash bottles ProbeWash is used to wash the inside of the reagent probe
to prevent reagent carryover.
u Related topics
Sampling area of the e 602 module

material into AssayCups on the incubator disk.
A
B
C
A Sample pipetter C AssayTip disposal openings

B AssayTip buffer station
AssayTip buffer station For each sample, the magazine gripper inserts a new
AssayTip into the AssayTip buffer station.
Roche Diagnostics
Sample pipetter The sample pipetter takes up the AssayTip from the
AssayTip buffer station. The sample pipetter aspirates
sample, calibrator, or QC material from containers on the
racks and dispenses the material into AssayCups on the
incubator disk. The sample pipetter has liquid level
detection and clot detection.
magazine drawer.
u Related topics
Pre-wash area of the e 602 module

Some tests demand a pre-wash of the reaction mixture
before measuring. During the pre-wash, serum
constituents that are not bound to microbeads are
removed from the reaction mixture.

A
B
C D E
A PreClean supply nozzle D Separation stations

B Pre-wash sipper nozzle E Vortex mixer
C Rinse station F Pre-wash gripper
Roche Diagnostics
Pre-wash gripper The pre-wash gripper transports AssayCups:

• From the incubator disk to the separation stations
• From the separation stations to the vortex mixer
• From the vortex mixer to the incubator disk
Separation stations The permanent magnets of the 2 separation stations

capture the microbeads with the attached immune
complex in the AssayCups.
Pre-wash sipper nozzle The pre-wash sipper nozzle aspirates reaction mixture and
PreClean M solution from the AssayCups in the separation
stations.
PreClean supply nozzle The PreClean supply nozzle supplies PreClean M solution
to the AssayCups in the separation stations. PreClean M
solution removes serum constituents that may influence
the measurement.
Rinse station The rinse station rinses the nozzles in the pre-wash area
Vortex mixer After the pre-wash, the vortex mixer brings the microbeads
back into suspension.
u Related topics
Roche Diagnostics
Measuring area of the e 602 module

The measuring area has 2 channels. Each channel has an
ECL sipper nozzle and a measuring cell. The ECL sipper
nozzles aspirate reaction mixture, ProCell M solution, and
CleanCell M solution into the respective measuring cells.
B
C
A ECL sipper nozzles C CC cup

B PC cup D Rinse stations

ECL sipper nozzles Each ECL sipper nozzle aspirates the following liquids:
• ProCell M solution to prepare the measuring cell.
• Reaction mixture from an AssayCup on the incubator
disk. The immune complexes are bound to microbeads.
• ProCell M solution to wash the microbeads with the
before measuring.
• CleanCell M solution and ProCell M solution to rinse the
measuring cell after measuring.
PC cup The ECL sipper nozzles aspirate ProCell M solution from

the PC cup. The PC cup is refilled from the ProCell M
CC cup The ECL sipper nozzles aspirate CleanCell M solution from

the CC cup. The CC cup is refilled from the CleanCell M
Roche Diagnostics
Rinse stations Each ECL sipper nozzle has a rinse station. After aspirating
the reaction mixture, the outside of the ECL sipper nozzle
is rinsed with deionized water.
Measuring cells The measuring cells magnetically capture the microbeads

with the attached immune complex that is to be
determined. All other serum constituents and unbound
reagents in the measuring cells are washed away with
ProCell M solution. A photomultiplier measures the light
signal that is emitted by the ruthenium marker on the
immune complex under the effect of an electrical field.
u Related topics
• About the ECL measuring principles (1906)
Front view of the e 602 module
C
A Syringes C Magazine drawer

B System reagent bottles
In this section
Syringes of the e 602 module (215)
System reagent bottles of the e 602 module (217)
Magazine drawer of the e 602 module (218)
Roche Diagnostics
Syringes of the e 602 module

The syringes are connected to the respective probes and
nozzles. The syringes aspirate and dispense reagents,
sample, microbeads, reaction mixture, and system
reagents. The syringes are filled with degassed and
deionized water.
A B C D
A Pre-wash syringe D Reagent syringe

B ProCell syringe E Sample syringe

C CleanCell syringe F Sipper syringes
Pre-wash syringe The pre-wash syringe is used for the pre-wash sipper
nozzle and the PreClean supply nozzle of the pre-wash
area. The pre-wash sipper nozzle aspirates reaction
mixture and PreClean M solution from the AssayCups in the
separation stations. The PreClean supply nozzle supplies
PreClean M solution from the PreClean M bottles to the
AssayCups in the separation stations.
ProCell syringe The ProCell syringe aspirates ProCell M solution from the
ProCell M bottles and dispenses the solution into the PC
cup in the measuring area.
CleanCell syringe The CleanCell syringe aspirates CleanCell M solution from

the CleanCell M bottles and dispenses the solution into the
CC cup in the measuring area.
Roche Diagnostics
Reagent syringe The reagent syringe is connected to the reagent probe.

The reagent probe aspirates pretreatment reagent,
cassettes and dispenses them into AssayCups on the
incubator disk.
Sample syringe The sample syringe is connected to the sample probe. The
sample probe aspirates sample, calibrator, or QC material
from containers on the racks and dispenses the material
Sipper syringes The sipper syringes are connected to the ECL sipper
nozzles in the measuring area. The ECL sipper nozzles
aspirate the following liquids into the respective measuring
cells:
• ProCell M solution to prepare the measuring cell.
• Reaction mixture from an AssayCup on the incubator
disk.
• ProCell M solution to wash the microbeads with the
before measuring.
• CleanCell M solution and ProCell M solution to rinse the
measuring cell after measuring.
u Related topics
• Reagent area of the e 602 module (209)
• Pre-wash area of the e 602 module (211)
• Measuring area of the e 602 module (213)
Roche Diagnostics
System reagent bottles of the e 602 module

The e 602 module holds 2 bottles of each system reagent
behind the front door. For each system reagent, you can
replace one bottle without interrupting operation. To avoid
misplacing bottles, the positions of the ProCell M bottles
and CleanCell M bottles are keyed.
B C
A PreClean M bottles C CleanCell M bottles

B ProCell M bottles
PreClean M bottles PreClean M solution is used to pre-wash the reaction

mixture. The pre-wash removes serum constituents that
may influence the measurement.
ProCell M bottles ProCell M solution is used to prepare the measuring cells.

The solution washes away all serum constituents and
unbound reagents other than microbeads with the
attached immune complex.
CleanCell M bottles CleanCell M solution is used to clean the measuring cells

after measuring.
u Related topics
Roche Diagnostics
Magazine drawer of the e 602 module

The magazine drawer holds the magazines with the
disposable AssayCups and AssayTips. The magazine
drawer also stores the resulting waste, that is, used
AssayTips, used AssayCups, and empty magazines.
A B C
A Magazine lifter C Magazine waste compartment

B Solid waste containers D WasteLiner (1 per solid waste container)
Magazine lifter The magazine lifter holds up to 12 magazines. The

magazine gripper of the consumables area can access the
topmost magazine.
Solid waste containers The solid waste containers hold one WasteLiner each. The
2 compartments are used alternately to dispose of used
AssayTips and AssayCups.
WasteLiner A WasteLiner receives the used AssayTips and AssayCups

for subsequent disposal.
Magazine waste compartment Empty magazines are disposed of into the magazine waste
compartment.
u Related topics
Roche Diagnostics
Rear view of the e 602 module
G
H
A B C D


regulations.
consumption times.
empty it.
water supply.
Roche Diagnostics
supply.
u Related topics
consumption (2007)
consumption (2009)
• List of concentrated liquid waste volumes (2010)
Roche Diagnostics
221
Table of contents
Overview of operation 3
In this chapter 3
Overview of the user interface. . . . . . . . . . . . . . . . . . . . 223
About the screen areas. . . . . . . . . . . . . . . . . . . . . . . 224
About the Overview menu . . . . . . . . . . . . . . . . . . . . 227
About the main menus . . . . . . . . . . . . . . . . . . . . . . . 230
About the status colors . . . . . . . . . . . . . . . . . . . . . . 233
Working through the menus (recommended
sequence) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
Printing reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
List of instrument modes . . . . . . . . . . . . . . . . . . . . . 237
List of keyboard shortcuts . . . . . . . . . . . . . . . . . . . . 238
Using the help system . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Displaying tooltips . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Displaying the Online Help . . . . . . . . . . . . . . . . . . . . 241
Searching in the Online Help . . . . . . . . . . . . . . . . . . 241
Searching using the table of contents . . . . . . . 242
Searching using the index. . . . . . . . . . . . . . . . . . 242
Searching for text . . . . . . . . . . . . . . . . . . . . . . . . 243
About text search options . . . . . . . . . . . . . . . . . 243
Using favorites in the Online Help . . . . . . . . . . . . . . 244
Adding a favorite . . . . . . . . . . . . . . . . . . . . . . . . . 244
Displaying a favorite . . . . . . . . . . . . . . . . . . . . . . 245
Overview of cobas® link . . . . . . . . . . . . . . . . . . . . . . . . . . 246
About cobas® link. . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
3 Overview of operation
About the cobas® link information flow. . . . . . . . . . 249
About cobas® e-library . . . . . . . . . . . . . . . . . . . . . . . 250
Searching for QC Value Sheets for systems
connected to a LIS. . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Roche Diagnostics
222
Table of contents
Roche Diagnostics
Overview of the user interface 223
Overview of the user interface

To operate the instrument, you must be familiar with the
user interface of the control unit.
In this section
About the screen areas (224)
About the Overview menu (227)
About the main menus (230)
About the status colors (233)
Working through the menus (recommended
sequence) (234)
Printing reports (236)
List of instrument modes (237)
List of keyboard shortcuts (238)
Roche Diagnostics
224 Overview of the user interface
About the screen areas

The user interface of the control unit has different areas.
A E
B
F
A Status line E Help buttons

B Main menu tabs F Overview button
C Menu area G Global buttons
D Help line
To operate the user interface, use the touch screen,

mouse, or keyboard.
Status line
The status line contains the following information:

• Instrument mode
• Operator ID
• Date and time
Depending on the instrument mode, further information is

displayed (e.g., the remaining time for software-controlled
maintenance actions or for Rack Reception mode).
u List of instrument modes (237)
Roche Diagnostics
Main menu tabs
To display 1 of the 5 main menus, choose the respective

main menu tab.
u About the main menus (230)
Overview button
To display the Overview menu, choose the Overview

button.
u About the Overview menu (227)
Menu area – Overview menu
The Overview menu is the starting point for all routine

operations. The Overview menu guides you through
preparing for daily operation and contains status
information about the modules of the instrument.
u About the Overview menu (227)
Menu area – main menus
In the 5 main menus, you manage the instrument and

evaluate test data. Each main menu has two or more
submenus.
u About the main menus (230)
Help line
The help line displays hints depending on the position of

the cursor.
Hints suggest actions or types of information for data

entry.
Roche Diagnostics
Help buttons
The help buttons display the following information:
? To display a tooltip about a software

element.
Help To display the Online Help. The Online

Help is context-sensitive and contains
the full Operator’s Manual and the
Software Description.
u Using the help system (240)
Global buttons
The global buttons provide quick access to the key

functions of the instrument.
Stop To stop operation in an emergency.
Logoff To log off.
S.Stop To stop further sampling. Racks in the

input buffer are not loaded further.
Racks in the module sample buffers are
moved to the output buffer. Racks in
modules are processed further and then
moved to the output buffer.
Alarm To display the alarm list. If an alarm has

been issued, the Alarm button flashes
yellow or red.
Monitor To view the calibration, QC, and patient

reports (results only). The data is
deleted when the system is switched off.
Print To print predefined lists and reports.
Start To choose start options and to start

analysis.
u Related topics
• About the Overview menu (227)
• About the main menus (230)
• List of instrument modes (237)
• Using the help system (240)
Roche Diagnostics
About the Overview menu

The Overview menu is the starting point for all routine
operations. The menu guides you through preparing for
daily operation and contains status information about each
module.
B
C
A Workflow guide D Module buttons
B Module overview E Symbol buttons
C Status overview F Temperature display
Roche Diagnostics
Workflow guide
The buttons in the Work Flow Guide group box guide you
through preparing for daily operation. From left to right,
the buttons represent the order of the required actions. If
a button turns yellow or red, you must act. To display the
dialog box that supports the required action, choose the
respective button.
Preventive Action To display a purple reagent

alarm if a reagent volume is
below the set daily workload
Daily Maintenance To perform software-controlled

maintenance actions
Sample Data Clear To back up sample data and to

clear the sample database for
faster access
Reagent Preparing To load reagents according to

the reagent load/unload list
Calib. and QC Select To perform recommended

calibration and to perform QC
for all tests before operation
Parameter Download To download application

settings, calibrator data, and QC
material data from the
cobas® 8000 data manager
Sample Tracking To observe the progress of

sample processing
u Preparing the instrument for operation (285)

u Downloads from cobas® link (250)
Module overview
The module overview contains color-coded status

information about the modules of the instrument and the
connection to the cobas® 8000 data manager. If a
pre-analytical system is installed, information about the
connection to this system is displayed too.
The button colors indicate the status or alarm level for

each module/component. The background color indicates
the overall instrument mode.
Roche Diagnostics
Status overview
The status overview contains color-coded, top-level status

information. If a field turns yellow, red, or gray, you must
act.
Data Manager This field indicates the

communication status between
the instrument and the
cobas® 8000 data manager. For
administrators, the Data
Manager field is a button. If you
press the button, it displays
detailed information.
Control Unit This field indicates the overall

mode of the instrument. For
status information on individual
modules, consult the module
buttons.
Clas Connect. This field indicates the status of

the connection to the pre-
analytical system.
Module buttons
Each module on the instrument has a module button.

Modules include the core unit, the ISE module, the module
sample buffers, and the analytical modules. You can
configure the text on the button labels.
If a button turns yellow or red, you must act. Choose the

respective module button to display a module-specific
alarm list or to stop software-controlled maintenance
actions on the module.
Symbol buttons For information about samples or reagents on the

instrument, choose the respective symbol button. If a
button turns yellow or red, you must act.
To display an overview of the samples in the output buffer

or to search for a sample on the instrument
To display the reagents on the ISE module
To display the reagents on a c 701 or c 702 module
To display the reagents on a c 502, e 801, or e 602

module
Roche Diagnostics
To display the reagent cassettes in the reagent manager

of a module sample buffer connected to a c 702 module
To display the reagent cassettes on the unloading tray of

a c 702 module
To display the temperatures of temperature-sensitive

e 801 or e 602 components, for example, the
temperature of the incubator disk.
Temperature display
The temperature display indicates the temperatures of

temperature-sensitive components in the modules (e.g.,
for each reagent disk, reaction disk, incubator disk, and
measuring cell).
u Related topics
• About the screen areas (224)
• About the main menus (230)
• About the status colors (233)
• Quick reference: Main workflow (257)
• Preparing the instrument for operation (285)
About the main menus

In the 5 main menus, you manage the instrument and
evaluate test data. Each main menu has two or more
submenus. If you have an operator level password only,
you cannot edit all the settings.
Workplace menu
The Workplace menu has the following submenus:
Test Selection To order tests for samples manually
Data Review To review and edit sample and QC

results
Calib. Review To review the status of the

calibrators used during operation
u Test Selection submenu (1491)

Data Review submenu (1504)
Calib. Review submenu (1544)
Roche Diagnostics
Reagent menu
The Reagent menu has the following submenus:
Setting To view information about loaded

reagents and to load and unload
reagents
Status To check the number of remaining

tests for reagents, the remaining
volume of system reagents, the
onboard stock of consumables, and
to reset the volumes of system
reagents
u Setting submenu (1549)

Status submenu (1572)
Calibration menu
The Calibration menu has the following submenus:
Status To view the calibration status of the

tests and to select tests for
calibration
Calibrators To view the already registered

calibrators and their rack
assignment and to assign a
non-barcoded calibrator to a rack ID
and position
Install To view and download calibrator

information and to update calibrator
data
u Status submenu (1581)

Calibrators submenu (1616)
Install submenu (1621)
Roche Diagnostics
QC menu
The QC menu has the following submenus:
Status To view the QC status of the tests

and to select tests for QC
Run Status To view recent QC measurements for

current and standby reagent
cassettes
Controls To view the already registered QC

material and their rack assignment
and to assign non-barcoded QC
material to a rack ID and position
Install To download QC material data from

the cobas® 8000 data manager
u Status submenu (1635)

Run Status submenu (1641)
Controls submenu (1644)
Install submenu (1648)
Utility menu
The Utility menu has the following submenus:
System To configure the system settings
Maintenance To perform maintenance actions and

to track maintenance
Application To download application settings

from the cobas® 8000 data manager
Special Wash To download special wash data for

the sample probe, reagent probe,
and the reaction cells
System To assign tests to modules. To

Configuration activate and deactivate modules. To

set up a connection to a pre-
analytical system
u System submenu (1661)

Maintenance submenu (1744)
Application submenu (1816)
Special Wash submenu (photometric and e 602
tests) (1855)
System Configuration submenu (1876)
u Related topics
• About the screen areas (224)
• About the Overview menu (227)
Roche Diagnostics
About the status colors

Status colors inform you about the status of modules and
reagents.
Color coding The general meaning of the colors is as follows:
Module in Standby mode.

cobas® 8000 data manager/pre-analytical system:
Connection OK
Module not in Standby mode (e.g., Maintenance mode,

Operation mode)
Reagent volume is less than the daily requirement
Action needed as soon as possible (e.g. because a

maintenance action is due or the number of remaining
tests for a reagent is below the yellow alarm level)
Action needed immediately (e.g., because of S.Stop,

Stop, or E.Stop, because there is no reagent for a test, or
a maintenance action is overdue)
Module is powered off.

cobas® 8000 data manager/pre-analytical system: No
connection
Examples
The cobas® 8000 data manager is online
The control unit is in Operation mode 3 Overview of operation
The remaining number of tests on the ISE module is below

the yellow alarm level
The reagent for at least one test on the c 701 or c 702

module is not on board or empty
The pre-analytical system is offline
Roche Diagnostics
Working through the menus (recommended sequence)

In order not to overlook any settings during setup or
troubleshooting, we recommend the following sequence
for working through the menus.
The sequence recommends an order for the main menus as

well as for the submenus.
r To work through the menus
1 1 On the Utility menu, work through the submenus from

left to right.
2
2 On the QC menu, work through the submenus from right
to left.
Roche Diagnostics
3
3 On the Calibration menu, work through the submenus
from right to left.
4
4 On the Reagent menu, work through the submenus from
right to left.
5
5 On the Workplace menu, work through the submenus
from left to right.
Roche Diagnostics
Printing reports
Reports can be displayed on the screen of the control unit
or printed on paper.
r To print a report
1 Choose the Print button.
2
2 Choose 1 of the following tabs:
• Workplace
• Reagent
• Calibration
• QC
• Utility
3
3 From the list on the left, choose the report to be
printed.
4
4 From the Module area, choose the data to be included
in the report.
5 Choose the Preview button.

f The icon on the Print button starts flashing.
6 Wait for the icon to stop flashing.
7
7 Choose the History tab.
Roche Diagnostics
8
8 To print the displayed preview of a report, do the
following:
• Choose the Print Out button.
• In the Print Range dialog box, choose the pages to
be printed.
I On the left, a list of the recently created reports is
displayed.
On the right, a preview of the chosen report in the
left list is displayed.
u Related topics
• Printing a load list and preparing the reagents (288)
• Printing load lists for calibrators and QC material (294)
• Requesting a maintenance report (800)
List of instrument modes

The current mode is displayed in the status line.
Power Up The instrument is loading programs,

performing self-checks, etc.
Initialize After powering up, the instrument

initializes.
Standby The instrument is ready for

operation.
Preparation The instrument prepares the

modules for operation, for example,
by washing reaction cells.
Operation The instrument is pipetting and

measuring.
Rack Supply No sample rack is left in the input
Complete buffer.
Rack Reception The instrument is waiting for more

sample racks.
Rack Collect End The instrument has finished

processing. All sample racks are in
the output buffer.
Post Operation The instrument prepares the

modules for Standby mode.
S.Stop The instrument stops sampling. Only

for sample racks already in the
modules, sampling and measuring is
finished. All other sample racks are
moved to the output buffer.
Roche Diagnostics
E.Stop The instrument has performed an

emergency stop due to hardware
failure, or because any of the safety
devices requested an E.Stop. The
instrument requires either a
complete power-off or a reset (Utility
> Maintenance) to resume operation.
Maintenance The instrument is performing

software-controlled maintenance
actions.
Backup Operation The instrument is ready to receive

racks at the backup operation ports
of the module sample buffers. You
can use this mode if the core unit is
out of order.
u Related topics
• Status line (224)
• About modes for maintenance (774)
List of keyboard shortcuts

For quick access to frequently used menus and dialog
boxes, use the following keyboard shortcuts:
F1 To display the Online Help
F2 To start measuring
F3 To stop further sampling
F4 To stop operation in emergency
F5 To display the Workplace menu

F6 To display the Reagent menu
F7 To display the Calibration menu
Ctrl+F7 To format a DVD for backup
F8 To display the QC menu
F9 To display the Utility menu
F10 To view the calibration, QC, and patient reports
F11 To display the alarm list
F12 To display the Overview menu
Print Screen To print predefined lists and reports
Shift+ To take a screenshot

Print Screen
Pause/Break To log off
Roche Diagnostics
u Related topics
• Global buttons (226)
Roche Diagnostics
240 Using the help system
Using the help system

To find information quickly, you may use the tooltips or the
Online Help.
In this section
Displaying tooltips (240)
Displaying the Online Help (241)
Searching in the Online Help (241)
Using favorites in the Online Help (244)
Displaying tooltips
Tooltips explain software elements on the screen.
r To display a tooltip
1 Choose the button for direct help.

f Next to the cursor, a question mark [?] is displayed.
2 Choose the software element you need information

about, for example, a button.
Roche Diagnostics
Using the help system 241
Displaying the Online Help

The Online Help displays detailed information about the
current menu or dialog box. It contains the full Operator’s
Manual and the Software Description.
r To display the Online Help
1
1 Navigate to a menu or dialog box you need information
about, for example, choose Calibration > Status.
2 Choose the Help button or press F1.
u Related topics
• Searching in the Online Help (241)
• Using favorites in the Online Help (244)
Searching in the Online Help
To find information in the Online Help, pick 1 of the
following search methods.
In this section
Searching using the table of contents (242)
Searching using the index (242)
Searching for text (243)
About text search options (243)
Roche Diagnostics
Searching using the table of contents

To find a topic you know about, search via the table of
contents.
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1
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and topic.
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via the index.
r To search via index
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2
2 In the search field, type a key word.
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Roche Diagnostics
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To revisit topics easily, use favorites.
In this section
Adding a favorite (244)
Displaying a favorite (245)
Adding a favorite
To create a list of favorites, add your favorite topics to the
list.
r To add a favorite
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1 In the Online Help, navigate to the topic you want to
revisit later.
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2 Choose the Favorites tab.

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1 In the Online Help, choose the Favorites tab.
f The list of favorites is displayed.
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Roche Diagnostics
246 Overview of cobas® link
Overview of cobas® link

cobas® link facilitates your work in several ways:
• Automatic download of current application settings,
calibrator data, QC material data, special washes, and
carryover rules from the Roche remote service platform
• Quick access to Instructions for Use (e.g., Method
Sheets, Value Sheets) in cobas® e-library
• Electronic storage of Instructions for Use
• Screen sharing with a Roche Service representative for
troubleshooting and support
In this section
About cobas® link (247)
About the cobas® link information flow (249)
About cobas® e-library (250)
Searching for QC Value Sheets for systems connected to a
LIS (252)
Roche Diagnostics
Overview of cobas® link 247
About cobas® link

To access the Roche remote service platform, the
cobas® 8000 data manager must be connected to a
cobas® link. The cobas® link is connected to the remote
service platform via a secure Internet connection.
You can access cobas® link via the sidebar in the

Remote service platform
The remote service platform provides information services

Remote service platform for you and the instrument.
The following services are available
Internet cobas® e-library Automatic download of current

Instructions for Use and
e-barcodes
cobas® link remote service Screen sharing with a Roche

Service representative for
troubleshooting and support
cobas® link
cobas® link is a software package running on a dedicated

Remote service platform computer in the laboratory, the cobas® link data station.
The data station and the software together are referred to
as the cobas® link.
Internet
The cobas® link connects cobas® 8000 data manager to
the remote service platform via a secure Internet
connection. The cobas® 8000 data manager
cobas® link communicates with the control unit of the instrument.
The cobas® link is set up and configured by a Roche Service

representative.
Roche Diagnostics
Online mode
In online mode, the cobas® link has a stable and secure

Remote service platform connection to the Internet.
The cobas® link downloads information for the connected

instruments from the remote service platform.
Internet
The cobas® 8000 data manager downloads e-barcodes

(machine-readable data with instructions related to
cobas® link reagents) from the cobas® link every 4 hours or after a
reboot of the cobas® 8000 data manager.
Subsequently, the control unit downloads the e-barcodes

from the cobas® 8000 data manager. This download must
be initiated via the daily maintenance pipe or by the
operator.
The cobas® link also uploads information from the

cobas® 8000 data manager to the remote service platform.
A filter on the cobas® 8000 data manager determines
which data is uploaded.
For example, the following data can be uploaded:

• Calibration results
• QC results
• Counters
• Instrument trace data
• Photometer check results
Offline mode
In offline mode, the cobas® link has no connection to the

Remote service platform Internet.
The cobas® e-library database is updated via update CDs.

The cobas® 8000 data manager downloads e-barcodes

(machine-readable data with instructions related to
reagents) from the cobas® link.
cobas® link
Subsequently, the control unit downloads the e-barcodes
from the cobas® 8000 data manager. This download must
be initiated via the daily maintenance pipe or by the
operator.
u About the cobas® link information flow (249)
u Related topics
• About the cobas® link information flow (249)
• About cobas® e-library (250)
Roche Diagnostics
About the cobas® link information flow

cobas® link communicates bidirectionally with the Roche
remote service platform and the cobas® 8000 data
manager.
Downloads from the remote service platform
Downloads from the remote service platform to the

Remote service platform cobas® link data station include the following:
• e-library data: contains Instructions for Use and
e-barcodes
Internet
cobas® link
Instructions for Use
The Instructions for Use comprise several documents, for

example:
• Method Sheets
• Value Sheets
• Important notes, for example, about reassigned values
for QC material
• Announcements from the local technical support
On the cobas® 8000 data manager, you can read the

Instructions for Use stored on the cobas® link via the
respective sidebar button.
u About cobas® e-library (250)
e-barcodes An e-barcode is a set of files with instructions related to a
reagent, for example:
• Application settings
• Values for calibrators and QC material
• Special washes
• Carryover rules
Roche Diagnostics
Downloads from cobas® link
The cobas® 8000 data manager downloads the e-barcodes

cobas® link from the cobas® link every 4 hours or after a reboot of the
If the cobas® 8000 data manager receives new

e-barcodes, the Parameter Download button on the
Overview menu of the control unit turns yellow to indicate
that new e-barcodes are available for download.
On the instrument, if you load a reagent cassette, a

calibrator, or QC material, but the corresponding
e-barcode was not downloaded yet, the Parameter
Download button on the Overview menu of the control unit
turns red to indicate that you must download the
respective e-barcode to the instrument immediately.
An automatic data synchronization between the

cobas® 8000 data manager and the control unit can be
included in the daily maintenance pipe performed after
power-on.
u Downloading parameters from the data manager (290)
Archiving Accredited laboratories must archive Instructions for Use

for many years.
u Related topics
• About cobas® link (247)
• Downloading parameters from the data manager (290)
• List of maintenance checks (807)
About cobas® e-library

The cobas® e-library application is an electronic storage
running on the cobas® link data station. You can access this
storage also from the cobas® 8000 data manager. You
must check daily for the latest Instructions for Use.
Access to cobas® e-library On the cobas® 8000 data manager, you can access cobas®
e-library via the respective sidebar button.
Roche Diagnostics
Content of cobas® e-library For each reagent, cobas® e-library contains the latest
version of the respective e-library data and the preceding
version. Any older e-library data is deleted from the cobas®
e-library.
cobas® e-library is updated daily via automatic download

from the Roche remote service platform.
e-library data e-library data contains Instructions for Use and

e-barcodes:
• Instructions for Use are for your information.
• e-barcodes contain machine-readable data with
instructions related to reagents. e-barcodes are
automatically downloaded to the cobas® 8000 data
manager every 4 hours. From there, you must download
them to the control unit of the instrument. An automatic
synchronization between the cobas® 8000 data
manager and the control unit can be included in the
daily maintenance pipe performed after power-on.
Instructions for Use The Instructions for Use comprise several documents, for
example:
• Method Sheets
• Value Sheets
• Important notes, for example, about reassigned values
for QC material
• Announcements from the local technical support
u Related topics
• About cobas® link (247)
• Searching for QC Value Sheets for systems connected
to a LIS (252)
Roche Diagnostics
Searching for QC Value Sheets for systems connected to

a LIS
Value Sheets are regularly updated and are available via
the cobas® e-library. When you use a new QC lot or reagent
lot, new QC values are transferred automatically to the
cobas® 8000 data manager and can be downloaded to the
instrument. However, if the instrument is connected to a
LIS, you must enter new QC values at the LIS manually.
For e 801 modules, there are QC Value Sheets for each QC

lot, containing all target values and ranges for each assay
and reagent lot.
You use the QC Value Sheets in the following cases:

• When you use a new QC lot, you must enter QC target
values and ranges into the LIS for all used assays.
• When you use a new reagent lot, new QC target values
and ranges might be available. Thus you must check
whether the currently used QC values are still valid for
the new reagent lot.
r To search for QC Value Sheets when

using a new QC lot
1
1 Check the kit lot number when opening a package with
a new QC lot.
2
2 At the cobas® e-library, search for the lot number of the
QC material (bottle lot or kit lot).
Roche Diagnostics
3
3 Select the latest version of the QC Value Sheet. The
latest version is marked by a blue rectangular icon.
• To open the QC Value Sheet in the PDF viewer,
choose the corresponding icon.
• Print the parts of the QC Value Sheet for the assays
to which the QC material is assigned to.
4 At the LIS, enter the target values and ranges to the

assays or reagent lots to which the QC material is
assigned to.
r To search for QC Value Sheets when

using a new reagent lot
1
1 To find out which QC lot number (bottle lot or kit lot) is
assigned to the assay, choose QC > Install.
2
2 At the cobas® e-library, search for the lot number of the
QC material (bottle lot or kit lot).
3
3 Select the latest version of the QC Value Sheet. The
latest version is marked by a blue rectangular icon.
• To open the QC Value Sheet in the PDF viewer,
choose the corresponding icon.
• Search for the new reagent lot number using the
shortcut Ctrl+F.
• Print the part of the QC Value Sheet for the
corresponding assay.
4 Compare the currently used target values and ranges

with the ones listed for the new reagent lot.
I Reagent lot-specific values are highlighted.
5 If the target values and ranges are different, enter the

target values and ranges for the new reagent lot into
the LIS.
Roche Diagnostics
u Related topics
• Installing QC material data from the data
manager (531)
Roche Diagnostics
255
Table of contents
Before operation 4
Start of a work shift
In this chapter 4
Quick reference: Main workflow. . . . . . . . . . . . . . . . . . . 257
Starting the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . 261
Powering on the instrument automatically. . . . . . . 262
Powering on the instrument manually. . . . . . . . . . . 264
Monitoring the execution of the daily maintenance
pipe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Checking the instrument performance . . . . . . . . . . 267
Powering on cobas e modules after extended
power-off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
Powering on cobas e modules after
24-64 hours of power-off. . . . . . . . . . . . . . . . . . 271
Powering on e 801 modules after 64 hours to
17 days of power-off . . . . . . . . . . . . . . . . . . . . . . 272
Powering on e 602 modules after 64 hours to
17 days of power-off . . . . . . . . . . . . . . . . . . . . . . 277
Troubleshooting system alarms . . . . . . . . . . . . . . . . . . . 284
4 Before operation
Preparing the instrument for operation . . . . . . . . . . . . 285

Performing daily maintenance . . . . . . . . . . . . . . . . . 285
Clearing the sample database . . . . . . . . . . . . . . . . . 287
Printing a load list and preparing the reagents . . . 288
Downloading parameters from the data manager 290
Performing recommended calibration and QC . . . 292
Requesting recommended calibration and QC 292
Printing load lists for calibrators and QC
material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
Measuring calibrators and QC material . . . . . . 295
Measuring samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299
Roche Diagnostics
256
Table of contents
4 Before operation
Roche Diagnostics
Quick reference: Main workflow 257
Quick reference: Main workflow

To prepare the instrument for daily operation, you must
perform the steps summarized in the workflow chart and
the quick reference table.
0DLQZRUNÁRZ
Software Top Front
1 Enter logon data 4 Check syringes and tubing system
2
If necessary, perform extended power-on
maintenance pipe
3 Check photometer report
5 Check for water splashes
6 Check system alarms
7 &KHFNZRUNÁRZEXWWRQV
8
Perform software-controlled maintenance
9 Clear sample database
10 Load/unload reagents
11
Download parameters from data manager 4 Before operation
12
Perform recommended calibration and
QC
13 Measure samples
Roche Diagnostics
258 Quick reference: Main workflow
Quick reference: Main workflow Starting situation: The instrument was powered on
automatically and has completed software-controlled
maintenance actions as part of the daily maintenance pipe
performed after power-on. The daily maintenance actions
were performed at the end of the last work shift.
Step User action

1 Enter your logon data.
2 If necessary, perform After a power-off period of more than 24 hours,

extended power-on you must perform the extended power-on
maintenance pipe. maintenance pipe to prepare the cobas e modules
for operation.
1. Choose Utility > Maintenance.
2. Choose the extended power-on maintenance
pipe.
3 During the execution of the Syringe problems cause inaccurate pipetting.
daily maintenance pipe, 1. Open the front doors of the modules.
check syringes and tubing 2. Make sure that no syringe is leaking.
system. 3. Make sure that there are no air bubbles in any
of the syringes.
4. Make sure that there is no leakage in the tubing
systems.
4 Check photometer report. The photometer report may indicate a problem

with the reaction cells, the photometer windows,
or the photometer lamps.
1. Choose Print > History.
2. Select the photometer check report.
3. Make sure that absorbance values do not
exceed 14 000.
4. Make sure that current values do not differ
significantly from previous results.
5 Check for water splashes. Water splashes around rinse stations indicate worn
or slightly clogged probes.
1. Open the top covers.
4 Before operation
2. Make sure that there are no splashes around

any of the rinse stations.
y Quick reference: Main workflow
Roche Diagnostics
Quick reference: Main workflow 259
Step User action

6 Check system alarms. 1. Choose the Alarm button.
2. Perform the recommended remedies until all
alarms are removed.
7 Check workflow buttons. 1. On the Overview menu, check which workflow

buttons are displayed in yellow or red.
2. Select the Preventive Action check box. (The
purple reagent alarm is displayed only if the
Preventive Action check box is selected.)
8 Perform software-controlled On the Overview menu, if the Daily Maintenance
maintenance actions. button is yellow or red, perform the following:
1. Choose Overview > Daily Maintenance.
2. Perform all required maintenance actions.
9 Clear sample database. For fast database access, you must clear the
sample database at the beginning of your shift.
1. Choose Overview > Sample Data Clear.
2. Choose the appropriate clear option
according to your laboratory data archive
policy.
10 Load/unload reagents. On the Overview menu, if the Reagent Preparing

button is purple, yellow, or red, perform the
following:
1. Choose Overview > Reagent Preparing.
2. Print the Reagent Load/Unload List.
3. Unload/load the reagents according to the
report.
11 Download parameters from On the Overview menu, if the Parameter Download

data manager. button is yellow or red, perform the following:
1. Choose Overview > Parameter Download.
2. Download the required data.
3. Repeat the calibration and QC measurements
4 Before operation
for the corresponding tests.
Roche Diagnostics
260 Quick reference: Main workflow
Step User action

12 Perform recommended 1. Choose Overview > Calib. and QC Select.
calibration and QC. 2. In the Calibration group box, choose the
Recommended button.
3. If a start-up group is specified, choose the
Start Up button to request calibration for this
group as well.
4. If the last shift started less than 24 hours ago,
request the ISE calibration manually.
5. Choose the Routine QC button.
6. Choose the Stand By Bottle QC button.
7. Print the load lists for the recommended
calibrators and QC material.
8. Place the calibrators and QC material on the
respective racks and load them into the input
buffer. Use only fresh calibrators and QC
material.
9. Start the calibration and QC measuring
process.
10. Check the calibration and QC results.
13 Measure samples. The following procedure assumes that test orders
are sent from a host.
1. Clear the Preventive Action check box.
2. Check that the green status indicators of the
input buffer are on.
3. Put the rack tray into the input buffer.
4. Start the measuring process.
5. To track sample processing, choose Overview
> Sample Tracking.
6. To review results, choose the Data Review
button.
u Related topics
• Starting the instrument (261)
• Powering on cobas e modules after extended power-
off (270)
• Preparing the instrument for operation (285)
• Measuring samples (299)
4 Before operation
Roche Diagnostics
Starting the instrument 261
Starting the instrument

If the instrument is powered off overnight, you can set a
Automatic start by time switch start-up time. In this case, the instrument is powered on
automatically before your work shift and executes the daily
maintenance pipe.
Precondition:
In preparation for an automatic start, you must perform the
manual maintenance actions at the end of each work shift.
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3
If a FREDV¬H¬PRGXOHZDVSRZHUHGRIIIRU
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procedure
If you power on the instrument manually, you can perform

Manual start the manual maintenance actions first. Then you monitor
the correct execution of the daily maintenance pipe. After
the daily maintenance pipe is completed, you must check
the instrument performance.
1
Perform manual maintenance actions and
power on instrument
2
Monitor execution of daily maintenance
pipe
3 Check instrument performance

4 Before operation
4
If a FREDV¬H¬PRGXOHZDVSRZHUHGRIIIRU
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procedure
Roche Diagnostics
262 Starting the instrument
What is the daily maintenance pipe? A maintenance pipe executes a set of software-controlled
maintenance actions. The daily maintenance pipe includes
all maintenance actions required for instrument start.
Typically the instrument is set up to perform the daily

maintenance pipe automatically at power-up. If you do not
use a daily maintenance pipe, you must manually execute
the maintenance actions included in the daily maintenance
pipe.
u Daily maintenance pipe (792)
Extended power-off (> 24 hours) If an e 801 or e 602 module has been powered off for more
than 24 hours, you must perform extra preparation steps.
In this section
Powering on the instrument automatically (262)
Powering on the instrument manually (264)
Monitoring the execution of the daily maintenance
pipe (266)
Checking the instrument performance (267)
Powering on cobas e modules after extended power-
off (270)
Powering on the instrument automatically

With the time switch at the front panel of the core unit you
power on the instrument at a set time.
To save time for routine operation, we recommend setting

the start-up time two hours before the work shift begins.
Then the instrument automatically performs all necessary
maintenance actions and is ready for operation when you
arrive.

4 Before operation
u Moving parts
u Ultrasonic mixers
u Skin inflammation or injury
j m The daily maintenance actions were performed at the

end of the last work shift.
m The time switch is set for automatic start.
m All covers and doors of the instrument are closed.
Roche Diagnostics
r To power on the instrument

automatically
1
1 Check if the time switch has powered on the instrument.
f The instrument starts initialization.
f After initialization, the instrument starts the daily
maintenance pipe.
2
2 Enter your logon data and choose the Logon button.
3
3 Wait until Standby mode is displayed. This mode
indicates that the daily maintenance pipe is complete.
4 Check the instrument performance.
u Related topics
• Setting the start-up time on the time switch (659)
• Monitoring the execution of the daily maintenance
pipe (266)
• Checking the instrument performance (267)
4 Before operation
Roche Diagnostics
Powering on the instrument manually

If you want to start before the set start-up time, you power
on the instrument with the power-on button.
The start procedure takes approx. 8–12 minutes until the

Standby mode is displayed. The time depends on the
module configuration and on software settings, for
example, if the Quick Start Mode for e 801 modules is
activated or not.
We recommend that you perform manual maintenance

actions at the end of each work shift. In this case, you can
skip step 1 of this procedure.

u Moving parts
u Ultrasonic mixers
j m The instrument is powered off.

m No manual maintenance is being performed.
m All covers and doors of the instrument are closed.
r To power on the instrument manually
1 Perform all manual daily and other required

maintenance actions.
2
2 Turn on the external water supply.
4 Before operation
Roche Diagnostics
3
3 To access the front panel, push against the left of the
cover.
4
4 Press the green power-on button.
maintenance pipe by the power up pipe function.
5
5 Enter your logon data and choose the Logon button.
maintenance pipe.
6 Monitor the execution of the daily maintenance pipe.
7
7 Wait until Standby mode is displayed. This mode
4 Before operation
indicates that the daily maintenance pipe is completed.
u Related topics
• Monitoring the execution of the daily maintenance
pipe (266)
Roche Diagnostics
Monitoring the execution of the daily maintenance pipe

If you start the instrument manually, you must monitor the
execution of the daily maintenance pipe.

u Abnormal condition
r To monitor the execution of the daily

maintenance pipe
1
1 Choose Utility > Maintenance.
2
2 Choose the Maintenance Monitor button.
3
3 In the Maintenance Monitor dialog box, observe the
execution of the maintenance actions until the air
purge is started.
4
4 Open the front doors of the ISE and cobas c modules.
4 Before operation
Roche Diagnostics
5
5 During air purge, check all syringes of the ISE and
cobas c modules for leakages and air bubbles.
A • If a syringe connector is leaking, fasten it finger-
tight.
B • If there are air bubbles in the syringe, tap your
A finger lightly against the syringe while the liquid is
flowing.
• If you cannot remove the leakage or air bubbles, call
your Roche Service representative.
I Leaking syringe connectors or air bubbles in a
A Syringe connectors B Syringe
syringe may lead to incorrect results.
6 Make sure that no other tubing connectors or

containers are leaking.
7 Close the front doors of all modules.
Checking the instrument performance

After the daily maintenance pipe has been completed, you
must check the functional integrity of the photometric
components with the photometer check report. You must
also check the instrument surfaces for water splashes.

d m Disposable cloth or paper towels

m Laboratory disinfectant (no bleach)
4 Before operation
Roche Diagnostics
r To check the instrument performance
2
2 Choose the History button.
f The list of reports currently available in the print
buffer is displayed.
3
3 Select the photometer check report.
4
4 Check the current absorbance values.
• If the current results exceed 14 000 absorbance
units at any wavelength or differ significantly from
the previous results, check the following points:
• Make sure that the reaction cells, the incubation
bath, and the photometer windows are free of
contamination or air bubbles.
• Make sure that the reaction cells are not scratched
or cracked.
• Make sure that the reaction cells are at least half
filled with water.
4 Before operation
• Then repeat the maintenance action photometer

check. If the results do not improve, replace the
photometer lamp.
Roche Diagnostics
5
5 Check the areas around the rinse stations of the ISE
and cobas c modules for water splashes. Water
splashes may occur during the maintenance action air
purge.
Splashes indicate that a probe is slightly clogged or
worn.
• If you detect splashes, put the module to manual
cleaning (Maintenance mode). This allows you to
move the probes manually.
• Wipe up any splashes with a paper towel moistened
with disinfectant.
• Eliminate clogging from the probe.
• If you cannot eliminate the clogging, call your
A B
• Choose the Cancel Maintenance button to
terminate manual cleaning (Maintenance mode).
u Related topics
• Putting a module in manual cleaning (Maintenance
mode) (783)
• Terminating manual cleaning (Maintenance mode) (784)
• Eliminating clogging of pipetter probes of the c 701
• c 701/c 702 module:
- Replacing reaction cells and cleaning the
incubation bath of the c 701 and c 702
C modules (919)
- Replacing the photometer lamp of the c 701 and
c 702 modules (941)
• c 502 module:
- Replacing reaction cells and cleaning the
incubation bath of the c 502 module (991)
- Replacing the photometer lamp of the c 502
module (1013)
4 Before operation
A c 701/c 702 module: C c 701/c 702 module:

Rinse stations of Rinse stations of
sample probes reagent probes
B c 502 module: Rinse D c 502 module: Rinse
station of sample stations of reagent
probe probes
Roche Diagnostics
Powering on cobas e modules after extended power-off

If a cobas e module has been powered off for more than
24 hours, you must perform an extended power-on
procedure to prepare the cobas e module for operation.
Power-on Extended power-on

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4 Before operation
In this section
Powering on cobas e modules after 24-64 hours of power-
off (271)
Powering on e 801 modules after 64 hours to 17 days of
power-off (272)
Powering on e 602 modules after 64 hours to 17 days of
power-off (277)
Roche Diagnostics
Powering on cobas e modules after 24-64 hours of power-off

If a cobas e module has been powered off for 24-64 hours,
you must prepare the module for operation by performing
specific maintenance actions.
Extended power-on 1 We recommend grouping the necessary maintenance

(after 24-64 hours powered-off) actions in a maintenance pipe. Then you only need to start
the maintenance pipe to execute all maintenance actions
with their specific options.
The maintenance pipe for extended power-on 1 must at

least contain the following maintenance actions:
Maintenance action Options Module

(36) System Air Purge (e602/e801) Ch 1,2 option e 801, e 602
5 cycles
(8) Reagent Prime Reagent option
5 cycles
(8) Reagent Prime Pre-wash option
5 cycles
(24) MC Preparation Ch 1,2 option
5 cycles
y Recommended maintenance actions for extended power-on 1
u List of recommended maintenance pipes (792)

u Moving parts
j m The instrument is in Standby mode.

m A maintenance pipe for extended power-on 1 is
created.
4 Before operation
r To prepare cobas e modules
1
2 Select the maintenance pipe for extended power-on 1.
Roche Diagnostics
5
5 During system air purge on e 602 modules, visually
check that the sample probe and reagent probe
discharge water in a straight flow. While the system air
purge is still in process, continue with steps 6 and 7.
I If water is not discharged in a straight flow, contact
6 WARNING! Incorrect results due to foam.

6 Open the front doors of all cobas e modules gently to
avoid the formation of foam in PreClean bottles.
7
7 Check all syringes for leakages and air bubbles.
• If a syringe connector is leaking, fasten it finger-
tight.
• If there are air bubbles in the syringe, tap your
flowing.
• If you cannot remove the leakage or air bubbles,
B contact your Roche Service representative.
A
• If you detect leakage at the bottom of a syringe,

A Syringe connectors B Bottom of syringe 8 Close the front doors of the cobas e modules gently to
avoid the formation of foam in PreClean bottles.
f After the maintenance pipe is completed, the
cobas e modules are ready for operation.
u Related topics
• Creating a maintenance pipe (787)
Powering on e 801 modules after 64 hours to 17 days of power-off

If an e 801 module has been powered off for more than
4 Before operation
64 hours, you must prepare the module for operation. If

the system has been powered off for more than 17 days,
We recommend grouping the necessary maintenance

actions in a maintenance pipe. You then simply start the
maintenance pipe to execute all maintenance actions with
their specific options.

Roche Diagnostics

5 cycles
5 cycles
5 cycles
30 cycles
d m Reagent cassettes
m ProCell II M, CleanCell M, and PreClean II M bottles
m PC/CC cups
m Magazines with AssayTips and AssayCups

created.
m All manual daily, every 2 weeks, and other required
maintenance actions are performed.
r To reload system reagents and

consumables
1 Open the front door of the e 801 module.
2
2 WARNING! Incorrect results due to foam. Handle the
new PreClean II M bottles gently to avoid the formation
of foam. WARNING! Incorrect results may occur due to
misplaced ProCell II M/CleanCell M/PreClean II M
bottles.
CAUTION! Delayed results may occur due to misplaced
ProCell II M/CleanCell M bottles.
The bottles are different in shape to fit the keyed
4 Before operation
position of the bottle stand. Ensure that the bottle
stand is present before placing the ProCell II M and
CleanCell M bottles.
2 Replace the ProCell II M, CleanCell M, and PreClean II M
bottles:
A B C
• Dispose of the ProCell, CleanCell, and PreClean
A PreClean II M bottles C CleanCell M bottles bottles according to local regulations.
B ProCell II M bottles • Carefully clean the ProCell/CleanCell aspiration
pipes. (u 1058)
• Put new ProCell II M, CleanCell M, and PreClean II M
bottles in place.
Roche Diagnostics

3 Close the front door of the e 801 module gently to
avoid the formation of foam in PreClean II M bottles.
4
4 At the front of the magazine drawer, open the
transparent door.
5 Load the full magazines onto the magazine lifter.
6 Close the transparent door completely.

f The next time the instrument accesses the
magazines, the level is checked, and the inventory is
automatically updated.
1
2
2 Power on the instrument manually.
f The system starts initialization and, if set, performs
the power-on maintenance pipe.
4 Before operation
Roche Diagnostics
3
3 Log on to the user interface.
4 Wait until the instrument enters Standby mode.
r To update system reagent and check

the microbeads mixer

1 Open the front door of the e 801 module gently to
1
2
2 To update all consumables, press the flashing green
A B
buttons corresponding to the new bottles.

4 Check the microbeads mixer. (u 1072)
A Green buttons for B Green buttons for

PreClean II M ProCell II M and
CleanCell M
r To empty and replace the PC/CC cups
1
4 Before operation
2
2 Choose the (32) Empty PC/CC Reservoir option.
Roche Diagnostics
4
4 Select the e 801 module.
6 Wait until the maintenance action is completed.

f The instrument or module returns to Standby mode.
7
7 Remove used PC/CC cups and put new cups in their
holders. (u 1062)
r To reload reagent packs
1 Reload the reagent packs to the e 801 module.

(u 416)
r To perform the extended power-on 2

pipe
1

4 Before operation
5 To observe the execution of the maintenance action,

choose the Maintenance Monitor button.
f The system displays the remaining time for each
maintenance action of the maintenance pipe.
6 During air purge on the e 801 module, visually check

that the sample probe and the reagent probe discharge
water in a straight flow. While the air purge is still in
process, continue with steps 7 and 8.
Roche Diagnostics

6
tight.
finger lightly against the syringe while the liquid is
flowing.

A B 9 Close the front door of the e 801 module gently to
A Syringe connectors B Bottom of syringe
u Related topics
• Powering on the instrument manually (264)
Powering on e 602 modules after 64 hours to 17 days of power-off

If an e 602 module has been powered off for more than
64 hours, you must prepare the module for operation
again. If the system has been powered off for more than
17 days, contact your Roche Service representative.
We recommend grouping the necessary maintenance

actions in a maintenance pipe. You then simply start the
maintenance pipe to execute all maintenance actions with
their specific options.
4 Before operation


5 cycles
5 cycles
5 cycles
30 cycles
Roche Diagnostics

u Moving parts
d m Reagent cassettes
m ProbeWash M, ProCell M, CleanCell M, and PreClean M
bottles
m PC/CC cups
m Magazines with AssayTips and AssayCups

created.
m All manual daily, weekly, every 2 weeks (LFC), and other
required maintenance actions are performed.
r To reload system reagents and

consumables
1
1 Replace the ProbeWash bottles:
• Dispose of the ProbeWash bottles according to
local regulations.
• Put new ProbeWash bottles in place.

avoid the formation of foam in PreClean M bottles.
4 Before operation
Roche Diagnostics
3
3 WARNING! Incorrect results may occur due to
misplaced ProCell M/CleanCell M bottles.
ProCell M and CleanCell M bottles are different in
shape to fit the keyed position of the bottle stand.
Ensure that the bottle stand is present before placing
the ProCell M and CleanCell M bottles.
3 Replace the ProCell, CleanCell, and PreClean bottles:
• Dispose of the ProCell, CleanCell, and PreClean
bottles according to local regulations.
• Put new ProCell, CleanCell, and PreClean bottles in
place.
4 Close the front door gently to avoid the formation of

A B C
foam in PreClean M bottles.
A PreClean bottles C CleanCell bottles
B ProCell bottles
5
transparent door.
7 Close the transparent door completely.

A f The next time the instrument accesses the
A Magazine lifter
1
4 Before operation
Roche Diagnostics
2
2 Power on the instrument manually.
f The system starts initialization and, if set, performs
the power-on maintenance pipe.
3
3 Log on to the user interface.
4 Wait until the instrument enters Standby mode.
r To update system reagent and check

the microbeads mixer

2
2 To update all consumables, press the flashing green
buttons corresponding to the new bottles.

4 Check the microbeads mixer. (u 1120)

4 Before operation
r To empty and replace the PC/CC cups
1
Roche Diagnostics
2
4
4 Select the e 602 module.

6
7 Put new PC/CC cups on the instrument. (u 1110)
A PC/CC cups
4 Before operation
Roche Diagnostics
r To reload reagent packs
1
1 Load the reagent cassettes onto the reagent disk
again. (u 445)
r To perform the extended power-on 2

pipe
1
5 To observe the execution of the maintenance action,

choose the Maintenance Monitor button.
f The system displays the remaining time for each
maintenance action of the maintenance pipe.
4 Before operation
6
6 During air purge on the e 602 module, visually check
that the sample probe and the reagent probe discharge
water in a straight flow. While the air purge is still in
process, continue with steps 7 and 8.

Roche Diagnostics
8
tight.
flowing.
B contact your Roche Service representative.
A

A Syringe connectors B Bottom of syringe
u Related topics
4 Before operation
Roche Diagnostics
284 Troubleshooting system alarms
Troubleshooting system alarms

If the Alarm button flashes yellow or red, you must check
the cause of the alarm.
The color indicates the alarm level:
Caution level. Operation can be continued.
Stop level. Operation cannot be continued.
q Alarms are displayed in chronological order with the

newest one at the bottom. The list can be sorted by
choosing one of the column headers.
r To troubleshoot system alarms
1 Choose the Alarm button.

f The alarm list contains all current alarms.
2
2 Select an alarm.
3
3 To remove the cause of the alarm, perform the
recommended remedy.
4 To delete the alarm from the list, choose the Delete

4 Before operation
button.
5 Repeat steps 2 to 4 for all alarms.
6 Choose the Close button.

f The Alarm button turns to normal.
Roche Diagnostics
Preparing the instrument for operation 285
Preparing the instrument for operation

To prepare the instrument for sample measurement, you
must perform some pre-routine actions.
The workflow on the Overview menu guides you through the

pre-routine actions.
Colors Perform at least the actions indicated in yellow or red.
This action is needed as soon as possible.
This action is needed immediately.
In this section
Performing daily maintenance (285)
Clearing the sample database (287)
Printing a load list and preparing the reagents (288)
Downloading parameters from the data manager (290)
Performing recommended calibration and QC (292)
Performing daily maintenance

If the Daily Maintenance button is displayed in yellow or
red, you must perform software-controlled maintenance
actions.
The color of the button indicates whether you must

perform at least one maintenance action: 4 Before operation
A warning level is exceeded.
A maintenance interval is exceeded.
A warning level is defined in percent. A maintenance

interval is defined in hours, days, or months.

m The Daily Maintenance button is yellow or red.
Roche Diagnostics
286 Preparing the instrument for operation
r To perform required maintenance
1
1 Choose the Daily Maintenance button.
2
2 From the left list, choose a maintenance type that is
displayed in yellow or red.
3 From the right list, choose a maintenance action or

maintenance pipe that is displayed in yellow or red.
I The right list contains the maintenance actions and
maintenance pipes and their last execution date.
If the date is yellow or red, the set warning level or
interval is exceeded.

f The dialog box for the selected maintenance action
opens.
5 Define any parameters required and choose the

Execute button.
6 Repeat steps 2 to 5 for all required maintenance

actions.
u Related topics
• Maintenance definitions (771)
• List of maintenance actions (802)
4 Before operation
Roche Diagnostics
Clearing the sample database

For faster data access, we recommend that you clear the
sample database at the beginning of each work shift.
The color indicates the storage space level of the sample

database:
If the Sample Data Clear button is yellow, you must clear

the sample database because it is almost full
If the Sample Data Clear button turns red, the sample

database is full (12 000 patient and QC samples). The
instrument will not process any further samples
The software provides 2 options:

• The Clear option deletes the database without saving
the test results. Use this option if the data is sent to the
host and you do not require another backup from the
instrument.
• The Backup and Clear option saves the test results on a
DVD. The test results are deleted afterwards.
r To back up the database before

clearing
1
1 Choose the Sample Data Clear button.
2 Insert a DVD.
3
3 Choose the Backup and Clear option.
4 Choose the OK button. 4 Before operation
Roche Diagnostics
5
5 Choose 1 of the following options:
• To back up all data in a binary file, choose the Data
Backup option. You can restore binary files to the
control unit but cannot use them on other PCs.
• To back up patient results or reaction data in a CSV
file, choose 1 of the CSV options. You can process
CSV files, for example, in a spreadsheet program,
but you cannot restore them to the control unit. If
you require text separators in the CSV file, select
the With Double Quotation Marks check box.
6 Enter a file name, for example, the current date.
7 To display the Save As dialog box, choose the

button.
8 Choose the OK button.

f After the backup, all test results are deleted from
the hard disk of the control unit.
u Related topics
• List of compatible DVD media (619)
• Formatting DVDs (620)
Printing a load list and preparing the reagents

If the Reagent Preparing button is purple, yellow, or red,
some reagents on board are running short or are empty.
You must load the required reagents according to the
reagent load/unload list.
The color of the Reagent Preparing button indicates the

number of available tests or the remaining volume:
Reagent is below the amount of reagent set for one day.

4 Before operation
Reagent is below the defined warning level.
Reagent is empty or missing.
Roche Diagnostics
r To print a reagent load/unload list
1
1 During pre-routine operation, select the Preventive
Action check box.
I The purple reagent alarm is only displayed while the
Preventive Action check box is selected.
2 Choose the Reagent Preparing button.
3
3 Choose the Reagent Load/Unload List button.
f The report is sent to the print buffer.
4 To view the report, choose the Print button.
5
5 Choose the History button.
6
6 If it is active, choose the Refresh button.
4 Before operation
7 Select the reagent load/unload list.
Roche Diagnostics
8
8 In the reagent load list, check the number of available
tests or the remaining volume in mL.
I The reagent initial load list shows the ratio of the
remaining number of tests to the set Initial Loading
Limit.
The number in brackets indicates the level set as
daily requirement (purple alarm).
9 In the reagent unload list, check which reagents must

Operator ID: admin9
be unloaded from the instrument.
Reagent Unload List
Pos. Test Reason Type
10 Unload and load the reagents according to the report.
A- 1 ALB2 R 1- R 2
A- 2 TP2 R 1- R 2
A- 3 IRON2 R 1- R 3 11 Dispose of empty reagents according to local
A- 4
A-5
PHOS2
ALTL Yellow
R 1- R 2
R1-R2
regulations.
A-6 CHO2A Yellow R1
A- 6 CHO2I R1 u Related topics
A- 7 GGTI2 R 1- R 2
A- 7 GGTS2 R 1- R 2 • Reagents of the ISE module (316)
A- 8 UREAL R 1- R 2
• Reagents of the c 701 module (326)
• Reagents and consumables of the e 801 module (390)
• Reagents and consumables on the e 602 module (440)
Downloading parameters from the data manager

To ensure accurate measurements, you must keep all
parameters up-to-date. Parameters are lot-specific
4 Before operation
application settings, calibrator data, QC material data, or

special wash data. The parameters are contained in the
corresponding file of the e-barcode.
The Parameter Download button indicates that new

parameters are available for download from cobas® link via
the data manager:
Updated or new parameters are available for installed

applications.
Important parameters are required by the instrument.
Roche Diagnostics
Lot numbers are encoded in barcode labels or RFID tags of

the reagents, calibrators, and QC material. If the used lot
numbers do not match the installed lot numbers or if the
target values have been adjusted by Roche, the Parameter
Download button turns red.
q You must ensure that the correct parameters for the

reagents, calibrators, and QC material in use are installed.
Check cobas® link regularly for parameter updates.
r To download parameters
1
1 Choose the Parameter Download button.
2
2 Check the 4 tabs for available parameters.
3 Select the desired parameter and choose the Download

button.
I We recommend downloading the latest release of a
parameter.
4
4 Select the desired settings and choose the OK button
to start the download.
4 Before operation
5 If you have downloaded new application parameters,

load the corresponding reagent cassettes.
6 Calibrate the corresponding tests and perform QC

measurements.
u Related topics
• Installing applications (704)
• Installing calibrator data from the data manager (488)
manager (531)
Roche Diagnostics
Performing recommended calibration and QC

The software automatically recommends calibration for all
tests that require calibration.
Typically, you also perform QC measurements for all tests

before operation. In that case, you probably do not need to
perform a QC measurement during operation.
• To activate the recommendation, you must request the

Performing recommended calibration and QC calibration and the QC measurement.
• You can print load lists with the required calibrators and
QC material.
1 Request calibration and QC • To start the measurement, you load the calibrators and
QC material on the respective racks.
• You make sure that all calibrations are valid and all QC
2 Print load lists
results are within the reference range.
In this section
3 Measure calibrations and QCs
Requesting recommended calibration and QC (292)
Printing load lists for calibrators and QC material (294)
4 Check results Measuring calibrators and QC material (295)
Requesting recommended calibration and QC

The software recommends calibrations according to the
intervals set in the application. However, you must activate
the recommended calibrations. To ensure measurement
accuracy, you must also perform a QC measurement for all
tests.
The yellow Calib. and QC Select button indicates that

calibration and/or QC are recommended.
4 Before operation
QC after calibration QC after calibration is a fully automatic function which

causes a QC measurement for all newly calibrated tests. If
you require QC measurements only for newly calibrated
tests, you do not need to choose the Routine QC button
and Standby Bottle QC button. When you load the required
QC racks directly after the calibrator racks, the QC will
automatically be measured after calibration.
c Before measuring samples
Roche Diagnostics
d m Calibrators and QC material

m Cups or sample tubes
m Calibrator racks (black)
m QC racks (white)
r To request recommended calibration

and QC
1
1 Choose the Calib. and QC Select button.
2
2 In the Calibration group box, choose the Recommended
button.
f The recommended calibrations are now requested
on an internal worklist and will be performed at the
beginning of the next run.
3 Check if the following steps are necessary:

• If a start-up group is defined for this work shift,
choose the Start Up button to request the
calibration for this group in addition to the
recommended tests.
• If your work shift starts within less than 24 hours
since the last work shift, request an ISE calibration
manually.
4
4 In the QC group box, choose the Routine QC button.
5 Choose the Stand By Bottle QC button (optional).

f QC measurements are now requested for all
reagents on board (in use and standby reagents).
4 Before operation
u Related topics
• About recommended calibration (472)
• Calibrating the ISE module (322)
• Creating a start-up group (480)
Roche Diagnostics
Printing load lists for calibrators and QC material

To see the required calibrators and QC material, you can
print a calibrator load list and QC load list. The load lists
also show rack positions assigned to specific calibrators or
QC material.
r To print load lists for calibrators and

QC material
1
1 In the Calibration group box, choose the Load List Print
button.
2
2 In the QC group box, choose the Load List Print button.
4 To view the reports, choose Print > History.
5
5 Select the calibrator load list and then the QC load list.
4 Before operation
Roche Diagnostics
6 Check the required calibrators and QC material with

6
their assigned rack positions.
Operator ID: admin
Module Specific Rack
Module Rack Range
C1 C20004 - C20004
C2 C20005 - C20005
C3 C20006 - C20006
C4 C20007 - C20007
ISE -
Calibrators
Calibrator Code Lot ID Rack No. - Pos. Event
C F AS 00401 181260 C 20003- 2 18
C20004-2
C20005-2
C20006-2
C20007-2
H2O 00901 999999 C 20003- 1 38
C20004-1
C20005-1
C20006-1
C20007-1
Measuring calibrators and QC material

To calibrate the tests and monitor the instrument
performance, perform calibration and QC measurements
before you process samples.

u Expired calibrators or QC material
u Rack transfer mechanism
u Accuracy and precision
u Position mismatch when using non-barcoded samples
r To measure calibrators and QC

material
1
1 Prepare the calibrators and QC material in suitable
4 Before operation
containers.
• Use sample tubes, cups, or calibrator/QC vials. Do
not use micro cups for calibrators or QC material.
• Do not mix single and multi-calibrators on the same
rack.
• Make sure that there are no air bubbles on the
surface of the calibrator or QC material.
• Use black racks for calibrators and white racks for
A B
QC material.
A Calibrator rack B QC rack
Roche Diagnostics
2
2 If you use barcoded containers, observe the following:
• Turn the containers so the barcode readers can
scan the barcode.
• Do not place barcoded containers on racks
assigned for non-barcoded calibrators or QC
material.
3 If you use non-barcoded containers, place the

calibrators and QC material according to the manually
assigned positions printed in the load lists.
A B
A Correct B Incorrect
4
4 Place the racks onto a rack tray.
To perform QC after calibration, place the QC racks
directly behind the calibrator racks.
5
5 Make sure that the green status indicators are ON.
6 Load the rack tray into the input buffer.

4 Before operation
Roche Diagnostics
7
7 WARNING! Incorrect temperature of incubation water
Incorrect temperature of the incubation water may lead
to false results.
Depending on the ambient temperature, it can take up
7 Ensure that the Inc. fields and the Reac. fields display
incubation bath temperatures of 37 °C ± 0.1 °C before
you start measurements.
8 Choose the global Start button.
9 To start the calibration and QC measurement, choose

9
the Start button.
10
10 Check the calibration results:
• If the calibration is valid, unload the calibrators.
Dispose of the calibrators according to local
regulations.
• If the calibration has failed, check the alarms and
troubleshoot. Repeat the calibration for these
tests.
4 Before operation
Roche Diagnostics
11
11 On the QC Routine menu of the data manager, check
the QC results:
• If 1 QC result is out of range, you must check the QC
material, the instrument, and the reagent.
• If most of the QC results are out of range, you must
troubleshoot the cause before measuring samples.
u Related topics
• Specifications of containers (2031)
• Checking and viewing calibration results (481)
• Checking QC results (529)
• Alarms for calibrations (1206)
4 Before operation
Roche Diagnostics
Measuring samples 299
Measuring samples
When all indicated pre-routine steps have been completed,
you can start routine operation and measure samples.
The Sample Tracking button provides access to the Sample

Tracking dialog box. There you can observe the progress of
sample processing.
The described procedure implies that the test orders have

been sent from a host or LIS.
u For manual requests or non-barcoded samples, see:
Ordering tests (550)
About barcode and non-barcode mode (544).

d m Sample racks
m Cups and sample tubes
m Barcode labels
r To measure barcoded samples
1
1 Clear the Preventive Action check box.
f If the Preventive Action check box is cleared, no
purple reagent alarm will occur during routine
operation.
2
2 To load samples, do the following:
4 Before operation
• Prepare samples in suitable containers.
• Place the containers into racks.
• Turn the containers so that the barcode readers
can scan the barcode labels.
• Place the racks onto a rack tray.
A B
A Correct B Incorrect
Roche Diagnostics
300 Measuring samples
3
3 Make sure that the green status indicators are ON.
4 Load the rack tray into the input buffer.
5 Choose the global Start button.
6 In the Start dialog box, check all settings and choose

6
the Start button.
f After a preparation routine, the sample processing
begins.
f The instrument scans the barcodes of the loaded
samples and requests the corresponding test
selection from the host.
7
7 To track the progress of sample processing, choose
System Overview > Sample Tracking.
8
8 To display details about samples, calibrators or QC
material, select the corresponding rack.
I You can track samples on the instrument as long as
you did not remove a rack tray and start a new run.
4 Before operation
9
9 To review results, choose the Data Review button.
Roche Diagnostics
Measuring samples 301
10
10 If a data alarm is attached to a test result, look up the
alarm description and perform the remedies.
• After all tests are measured and calculated, the
instrument returns to Standby mode. If the Rack
Reception mode is activated on Utility > System
> Rack Reception, the instrument remains in Rack
Reception mode for a set period to process further
samples.
• To terminate the Rack Reception mode, choose the
Change button in the Start dialog box.
• After the set period, the instrument performs
finalization on cobas e modules and returns to
Standby mode.
11
11 While the green status indicators are ON, unload the
measured samples and load new samples, calibrators
or QC material.
12 Dispose of samples according to local regulations.
13 To start the next run, choose the Start button.
u Related topics
• List of standard containers (2031)
• Ordering tests (550)
• Placing barcode labels on sample tubes (559)
• Loading samples (562)
• Processing rerun tests (595)
• Working with sample results (581)
• List of data alarms for tests (1159)
4 Before operation
Roche Diagnostics
302
4 Before operation Measuring samples
Roche Diagnostics
303
Table of contents
Reagents 5
In this chapter 5
About reagent statuses. . . . . . . . . . . . . . . . . . . . . . . . . . 307
Defining the reagent warning levels . . . . . . . . . . . . . . . 310
Working with reagent masking . . . . . . . . . . . . . . . . . . . . 312
Removing reagent masking. . . . . . . . . . . . . . . . . . . . 312
Masking and unmasking reagent cassettes . . . . . . 314
Reagents of the ISE module . . . . . . . . . . . . . . . . . . . . . . 316
About ISE reagents . . . . . . . . . . . . . . . . . . . . . . . . . . 316
About ISE system reagents. . . . . . . . . . . . . . . . . . . . 317
Changing ISE module reagents . . . . . . . . . . . . . . . . 318
Performing a reagent prime on the ISE module. . . 321
Calibrating the ISE module . . . . . . . . . . . . . . . . . . . . 322
Changing sample probe wash solutions on the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324
Reagents of the c 701 module. . . . . . . . . . . . . . . . . . . . 326
About c 701 module reagents . . . . . . . . . . . . . . . . . 326
About c 701 module system reagents . . . . . . . . . . 328
About changing reagent cassettes of the c 701
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
Changing reagent cassettes on the c 701 module 330
Loading development channel reagents on the
c 701 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
Changing reaction cell wash solutions on the
c 701 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337
Changing sample probe wash solutions on the
c 701 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 340
About changing reagent cassettes on the c 702
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346
Loading reagent cassettes on the c 702 module . 349
5 Reagents
Unloading reagent cassettes from the c 702

module unloading tray. . . . . . . . . . . . . . . . . . . . . . . . 353
Manually selecting reagent cassettes for
unloading from the c 702 module . . . . . . . . . . . . . . 356
module reagent manager . . . . . . . . . . . . . . . . . . . . . 359
Emptying the cap waste box of the c 702 module 361
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
Roche Diagnostics
304
Table of contents

c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 370
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 376
Loading reagent cassettes on the c 502 module . 378
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 380
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 382
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 384
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386
Changing the ECO-D bottle on the c 502 module 388
Reagents and consumables of the e 801 module. . . . 390
About cobas e flow tests on the e 801 module. . . 391
About basic cobas e flow test concepts of the
e 801 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
About types of cobas e flow tests on the
e 801 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 393
About calibration and QC for embedded tests
on the e 801 module . . . . . . . . . . . . . . . . . . . . . . 395
Overview of reagent status information for
embedded tests on the e 801 module . . . . . . . 396
About coordinating work on the e 801 module
and the data manager. . . . . . . . . . . . . . . . . . . . . 398
About multi-application tests on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 398
About e 801 module reagents and consumables . 399
About e 801 module system reagents . . . . . . . . . . 401
About changing reagent cassettes on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403
Changing reagent cassettes on the e 801 module 403
About changing reagent cassettes on the
e 801 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404
About the reagent manager of the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 408
List of status indicators and button statuses
on the e 801 module . . . . . . . . . . . . . . . . . . . . . . 411
5 Reagents
Manually selecting reagent cassettes for

unloading from the e 801 module . . . . . . . . . . . 412
Changing more than 5 reagent cassettes on
the e 801 module in Standby mode . . . . . . . . . 413
Changing up to 5 reagent cassettes on the
e 801 module in Standby mode. . . . . . . . . . . . . 416
Changing reagent cassettes for later
processing on the e 801 module in Operation
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419
Roche Diagnostics
305
Table of contents
Changing reagent cassettes on the e 801

module for immediate processing in Operation
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 422
Linking pretreatment and assay reagent
cassettes on the e 801 module . . . . . . . . . . . . . . . . 425
About pretreatment reagents and the PT link
function on the e 801 module . . . . . . . . . . . . . . 425
cassettes on the e 801 module . . . . . . . . . . . . . 426
Linking reagent cassettes as part of linked kits on
the e 801 module. . . . . . . . . . . . . . . . . . . . . . . . . . . . 427
Changing system reagents on the e 801 module . 428
Changing ProCell II M and CleanCell M bottles
on the e 801 module . . . . . . . . . . . . . . . . . . . . . . 430
Changing PreClean II M bottles on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433
Replacing consumables and changing solid waste
boxes on the e 801 module . . . . . . . . . . . . . . . . . . . 436
Replacing consumables on the e 801 module 437
Changing solid waste boxes on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 438
Reagents and consumables on the e 602 module . . . 440
About e 602 module reagents and consumables . 440
About e 602 module system reagents . . . . . . . . . . 442
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 444
Changing reagent cassettes on the e 602 module 445
cassettes on the e 602 module . . . . . . . . . . . . . . . . 448
About pretreatment reagents and the PT link
function on the e 602 module . . . . . . . . . . . . . . 449
cassettes on the e 602 module . . . . . . . . . . . . . 450
Changing system reagents on the e 602 module . 452
Changing ProCell M and CleanCell M bottles
on the e 602 module . . . . . . . . . . . . . . . . . . . . . . 453
Changing PreClean M bottles on the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 456
Changing ProbeWash M bottles on the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 458
boxes on the e 602 module . . . . . . . . . . . . . . . . . . . 459
Replacing consumables on the e 602 module 460
Changing solid waste boxes on the e 602
5 Reagents
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461
Roche Diagnostics
306
Table of contents
5 Reagents
Roche Diagnostics
About reagent statuses 307
About reagent statuses

The reagent statuses are displayed in the Reagent
Overview dialog box of the corresponding module. The way
this information is displayed for the different modules
follows common principles.
Access to reagent statuses In the Module Overview panel of the Overview menu, symbol
buttons, for example or , provide access to the
Reagent Overview dialog box corresponding to the
individual modules.
Also, these Symbol buttons are colored for each module

depending on the overall reagent status of that module.
u Symbol buttons (1289)
Indication of reagent statuses In the Reagent panel and in the Inventory panel of the
Reagent Overview dialog box, the reagent statuses are
displayed. For reference, the possible reagent statuses
are listed in the Contents panel.
A B C D
E F G H I
A Reagent Overview dialog box (ISE module) F Inventory panel (ISE module)
B Contents panel (ISE module) G Reagent panel (e 801 module)
C Reagent Overview dialog box (e 801 module) H Positions of the reagent loader (e 801 module)
5 Reagents
D Contents panel (e 801 module) I Inventory panel (e 801 module)

E Reagent panel (ISE module)
w Overview of two exemplary reagent status displays
Roche Diagnostics
308 About reagent statuses
Types of reagents In general, there are 2 types of reagents:

• Primary reagents are test-specific and supplied in
reagent cassettes.
• System reagents are used across all tests and supplied
in larger quantities.
On the cobas e modules, there are also consumables.

Consumables are tips for pipetting and cups for
incubating.
Reagent panel In the Reagent panel, 3 colored segments display status

information about the primary reagents.
R. P. Remaining volume (ISE) or reagent cassette status

(cobas c modules and cobas e modules)
Cal. Calibration status
QC QC status
For the ISE module, the columns represent the fill level of
the ISE reagents. The 3 colored segments are displayed
below each column.
R. P. Top segment
Cal. Middle segment
QC Bottom segment
For the cobas c modules and cobas e modules, a

representation of the reagent disk is displayed. On the
reagent disk, the 3 colored segments represent each
reagent cassette.
R. P. Inner segment
Cal. Middle segment
QC Outer segment
For the cobas e modules only, the Cal. segment and the QC
5 Reagents
segment are subdivided representing the 2 measuring

channels.
Roche Diagnostics
About reagent statuses 309
Contents panel The Contents panel lists the possible statuses, which are
displayed by the 3 colored segments.
The possible statuses vary between the different modules.
Inventory panel The Inventory panel displays fill level information of the
system reagents.
For the cobas e modules, this panel also displays fill level
information of the consumables and the waste. Columns
represent the fill levels. Below the columns, the numeric
value of the fill level is additionally displayed. The
measurement unit of this numeric value varies between
modules and can be given in milliliters or percent for
reagents and in quantities for consumables.
u Related topics
• For detailed information about reagent statuses for
individual modules, see the Online Help:
- Reagent Overview window (ISE module) (1310)
- Reagent Overview window (c 701/c 702
module) (1314)
- Reagent Overview window (c 502 module) (1329)
- Reagent Overview window (e 801 module) (1335)
- Reagent Overview window (e 602 module) (1345)
5 Reagents
Roche Diagnostics
310 Defining the reagent warning levels
Defining the reagent warning levels

The instrument can issue an alarm on 3 warning levels for
reagents running low.
You can freely set at which amount of remaining reagent a

'HÀQLQJUHDJHQWZDUQLQJOHYHOV purple alarm or a yellow alarm is issued. You cannot set a
red alarm, it is fixed. These system alarms have the
following meaning regarding reagent levels:
1
Purple You use this alarm to set the amount of
Activate purple or yellow alarm
reagent for one day.
Yellow You use this alarm to set the minimum

2 amount of reagent that requires an
Set remaining volume or number of immediate change.
remaining tests
Red The red alarm indicates that the reagent is
empty or that air bubbles were detected.
3 You cannot set any reagent level for this
Activate preventive action (for purple
alarm only) alarm.
Measures of reagent warning levels For test reagents, you set the warning levels using the
number of remaining tests. For wash solutions and diluents,
you set the warning levels using the remaining volume (mL).
For immunology tests that require a pretreatment, the
total number of remaining tests relevant for the warning
levels depends on the PT link function. The total number is
determined by the lower number of remaining tests of the
2 linked reagent cassettes.
u About pretreatment reagents and the PT link function
About pretreatment reagents and the PT link function
Menus containing alarms Reagent level alarms are issued in 3 menus on the control
unit:
Menu Element highlighted by alarm
Overview menu The Reagent Preparing button
changes its color.
The Symbol buttons, for
example or , change their
color.
5 Reagents
Reagent > Setting The tests are marked in the

corresponding color.
Reagent > Status The tests are marked in the
corresponding color.
y Menus containing alarms
j m You need administrator access rights.
Roche Diagnostics
Defining the reagent warning levels 311
r To define a reagent warning level
1
1 Choose Utility > System > Reagent Level.
2
2 Choose the desired test, wash solution, or diluent.
3
3 To activate the alarm for a reagent warning level, select
one or both of the following 2 Activate Alarm check
boxes:
• For a yellow alarm, select the corresponding
Activate Alarm check box.
• For a purple alarm, select the corresponding
Activate Alarm check box.
4 Enter the remaining volume or number of remaining

tests, respectively, at which you want the alarm to be
issued.
5 Choose the Update button.
7
7 Choose the Overview menu.
8 To activate the purple alarm, select the Preventive

Action check box.
I Only if this check box is selected, the purple alarm
5 Reagents
can be issued.
Roche Diagnostics
312 Working with reagent masking
Working with reagent masking

The instrument masks a test when the corresponding
reagent cassette gets empty and no standby reagent
cassette is on board (reagent masking).
When there is a failure and you cannot troubleshoot at the

moment, you can mask individual reagent cassettes
(reagent cassette masking).
Reagent masking If a reagent is empty and no standby reagent cassette is on

board, the instrument masks the corresponding test
automatically. On cobas e modules, c 701 modules, and
c 702 modules, the test is masked if foam has been
detected. On e 602 modules, the test is masked if the
reagent has been open for a long time during operation.
Masked tests are excluded from the analysis.
Reagent cassette masking If you do not perform a test daily, you can temporarily mask
a specific reagent cassette.
Masked reagent cassettes are temporarily excluded from
the current analysis.
In this section
Removing reagent masking (312)
Masking and unmasking reagent cassettes (314)
Removing reagent masking

If a reagent is empty or has been open for a long time, and
no standby reagent cassette is on board, the instrument
masks the corresponding test automatically. Masked tests
are excluded from the analysis.
If reagent masking terminates sampling, a rerun test is

required for these samples.
Reagent masking is applied to:

• Reagents for the ISE module
• Reagents for the cobas c modules
5 Reagents
• Assay reagents, pretreatment reagents, and diluents

for the cobas e modules
Reagent masking is NOT applied to:

• Reaction cell wash solutions (CellCln1 and CellCln2)
• Diluents for the ISE module and for the cobas c
modules
• Reagent probe wash solutions D1 and D2
• ECO-D
Roche Diagnostics
Working with reagent masking 313
In Workplace > Test Selection, masked tests are displayed

with a red bar on the corresponding buttons.
j A test has been masked automatically due to one of the

following reasons:
m The reagent is empty and no standby reagent cassette
is available.
m Foam has been detected on the surface of the reagent
and no standby reagent cassette is available.
r To unmask reagent masking
1
1 If a test is masked because its reagent is empty, do the
following:
• Remove and dispose of the empty reagent cassette
according to local regulations.
• Load a new reagent cassette.
• On the c 701 and c 702 modules, perform a reagent
registration.
• On the Reagent > Setting menu, check the reagent
data, e.g., reagent volume, number of available
tests.
• Proceed with step 3.
f The test is unmasked automatically.
2
2 If a test is masked because there is foam on its reagent,
do the following:
• Remove the reagent cassette.
• Wait until the foam is gone.
• Replace the reagent cassette.
• Proceed with step 3.
I If the microbead mixer on the e 801 and e 602
modules produces foam repeatedly, contact your
f The test is unmasked automatically.
3 If sampling has been terminated by reagent masking, do

the following:
• From the output buffer, take the respective rack.
5 Reagents
• Place the rack into the input buffer.

• Start analysis.
Roche Diagnostics
314 Working with reagent masking
u Related topics
• For information about reagent masking, see:
- Overview of masking functions (639)
- About reagent expired masking on the e 801
module (697)
• For changing and loading reagent cassettes, see:
- Changing reagent cassettes on the c 701
module (330)
- Loading reagent cassettes on the c 702
module (349)
- Loading reagent cassettes on the c 502
module (378)
- Changing reagent cassettes on the e 801
module (403)
- Changing reagent cassettes on the e 602
module (445)
• For information about instrument alarms, see:
- About data alarms and instrument alarms (1157)
• For loading samples and starting analysis, see:
- Loading samples (562)
- Starting analysis (574)
Masking and unmasking reagent cassettes

If you do not perform a test daily, you can temporarily mask
a specific reagent cassette.
Masked reagent cassettes are temporarily excluded from
the current analysis.
Reagent cassette masking is possible on all modules

except the ISE module. Special reagents, diluents, wash
solutions, and pretreatment reagent cassettes cannot be
masked.
If the reagent cassette is part of a reagent kit, the entire

reagent kit is masked. If the reagent cassette is part of a
linked kit or linked test on the e 801 module, the linked
reagent cassettes are also masked.
5 Reagents
j m To mask a reagent cassette, the module can be in

Operation mode, Standby mode, or Rack Collect End
mode.
m To unmask a reagent cassette, the module must be in
Standby mode.
Roche Diagnostics
Working with reagent masking 315
r To mask or unmask reagent cassettes
1
2
2 Choose the Reagent Overview button of the
corresponding module.
3
3 On the reagent disk graphic, choose the reagent
cassette to be masked or unmasked.
f The Detail dialog box is displayed.
4
4 If you want to mask the selected reagent cassette,
choose the R. Pack Mask button.
f The instrument stops using this reagent cassette as
soon as possible. It may take up to 30 seconds until
a reagent cassette is masked. Masking is not applied
to pipetted samples.
f On the Reagent Overview dialog box and on the
Reagent menu, masked reagent cassettes are
displayed like empty reagent cassettes. If no other
reagent cassette for this test is available, masked
reagent cassettes are highlighted red.
q If there is another reagent cassette for the same

test, sample pipetting is continued without masking this
test.
5 Reagents
5 If the selected reagent cassette is masked and you

want to unmask it, choose the R. Pack Unmask button.
Roche Diagnostics
316 Reagents of the ISE module
Reagents of the ISE module

The ISE module requires specific reagents to operate.
In this section
About ISE reagents (316)
About ISE system reagents (317)
Changing ISE module reagents (318)
Performing a reagent prime on the ISE module (321)
Calibrating the ISE module (322)
module (324)
About ISE reagents

Reagents of the ISE module are supplied in various reagent
bottles.
ISE reagents ISE reagents are used for the measurement of sodium
(Na+), potassium (K+), and chloride (Cl-).
A B The reagent bottles for the ISE module are stored in a

drawer behind the front door.
C D E F
A REF-2—ISE Reference D DIL-2—ISE Diluent

Electrolyte
5 Reagents
B REF-1—ISE Reference E IS-1—ISE Internal

Electrolyte Standard
C IS-2— ISE Internal F DIL-1—ISE Diluent
Standard
Roche Diagnostics
Reagents of the ISE module 317
The reagent bottle for ECO-D for the ISE support box is
stored in the drawer behind the front door.
Reagents used for ISE measurement are:

• ISE Internal Standard (IS)
• ISE Reference Electrolyte (REF)
• ISE Diluent (DIL)
Additive used for ISE support box maintenance:

• ECO-D (ISE support box only)
A ECO-D
Calibrators and QC material Calibrators used for ISE measurement are:

Calibrator Software Code
ISE Standard Low, used as ISELOW 502
calibrator 1 Std (1)
ISE Standard High, used as ISEHIGH 503
ISE Standard High, used as ISECOMP 763
y ISE calibrators
QC material that is used for ISE measurement is the same

as the QC material that is used for photometric tests, for
example:
• PCCC 1
• PCCC 2
You must place calibrators onto black calibrator racks and

QC material on white QC racks.
u Calibrating the ISE module (322)
About ISE system reagents

5 Reagents
The ISE module requires ISE system reagents for

supportive processes of the measurements.
ISE system reagents For cleaning the ISE flow path, you use ISE Cleaning
Solution/Elecsys SysClean. You place SysClean solution
onto Rack Pos. 2 on the wash rack.
For conditioning the ISE electrodes, you use Activator. You

place Activator onto Rack Pos. 3 on the wash rack.
Roche Diagnostics
The ISE system reagents are used in maintenance actions

and provided via wash racks.
u Washing with the wash rack during continuous
operation (843)
Sample probe wash solutions For special washes of the sample probe, the instrument
uses 2 sample probe wash solutions. Sample probe wash
solutions are located in bottles next to the sample probe.
The instrument uses the following wash solutions:

• SmpCln1: alkaline wash solution
• SmpCln2: acid wash solution
u Changing sample probe wash solutions on the ISE
module (324)
Changing ISE module reagents

When the remaining volume of the ISE reagents is low, or
the expiry date has been exceeded, you change the ISE
reagent to ensure correct measurement.
The instrument monitors the remaining volumes of ISE

Changing ISE reagents reagents by counting down. After replacing an ISE reagent,
you reset the initial filling volume.
ISE IS ISE REF ISE DIL E&2-D
The system does not track the expiry date. You must track
expired reagents manually.
1 Replace bottle
To check for those reagents that should be changed, you
can print a reagent load/unload list.
2 2
Reagent Volume Reset + Prime Reset u Printing a load list and preparing the reagents (288)
u For information about the onboard stability of the
application, refer to the corresponding Instructions for
3 Calibrate
Use on cobas® e-library.

u Missing covers of the ISE module
u Expired reagents or mixing reagents
5 Reagents
u Foam, clots, films, or air bubbles
Roche Diagnostics
r To change ISE reagents
1
1 Open the front door of the ISE module.
2 From the empty reagent bottle, remove the tubing.
3 Check the aspiration filter at the end of the tubing and

clean it if necessary.
4
4 WARNING! Incorrect results due to incorrect insertion
of aspiration tubing. Insert the aspiration tubing so that
the end of the tubing touches the bottom of the bottle.
Do not bend the aspiration tubing.
4 Insert the aspiration tubing into the new bottle as
shown by A and fasten the cap.

misplaced ISE Diluent or ISE Internal Standard bottles.
5 Put the new bottle back in place. Make sure to place the
bottle according to its specified position.
I Ensure that you do not place the ECO-D bottle here.
A
6 Close the front door of the ISE module.
A Correct
7
7 Choose Reagent > Status.
8 From the Module drop-down list, choose the ISE option.
9
9 Choose the changed reagent.
10 To reset the filling volume for countdown, choose the

Reagent Volume Reset button.
5 Reagents
11 Perform a reagent prime.
12 Perform a calibration.
Roche Diagnostics
r To change ECO-D on the

ISE support box
1
1 CAUTION! Do not put excessive weights on the
ISE support box.
1 Open the front door of the ISE support box.
2 From the empty ECO-D bottle, remove the tubing.
3 Check the aspiration filter at the end of the tubing and

clean it if necessary.
4 Insert the aspiration tubing into the new bottle and

fasten the cap.

A
misplaced ISE Reference Electrolyte or ECO-D bottles.
A ECO-D 5 Put the new bottle back in place. Make sure to place the
bottle according to its specified position.
6 Close the front door of the ISE support box.
7
9
9 Choose the changed reagent.
10 To reset the filling volume for countdown, choose the

u Related topics
• Cleaning the reagent aspiration filters of the ISE
module (856)
• Performing a reagent prime on the ISE module (321)
• Air bubbles in syringes (1248)
5 Reagents
Roche Diagnostics
Performing a reagent prime on the ISE module

When the tubing has been disconnected from an ISE
reagent bottle, air may have entered the electrodes. After
you have changed ISE reagents, the ISE flow path must be
filled with new reagent. In these cases, you must perform a
reagent prime.
r To perform a reagent prime
1
1 Choose Overview > Reagent Preparing.
2
2 Choose the Reagent Prime button.
3
3 Select the ISE check box.
4
4 Do one of the following:
• From the Prime item drop-down list, choose the All
option.
• Choose the reagent corresponding to the changed
bottle.
5 Reagents
5 In the Cycles field, enter 20.

I 20 is the number of priming cycles recommended.

f The prime is complete when the instrument returns
to Standby mode.
Roche Diagnostics
Calibrating the ISE module

A calibration is only valid for only one set of ISE reagents.
After you have changed any ISE reagent bottle, you must
recalibrate the ISE module.
q The concentration of the ions increases due to

evaporation. This may result in an incorrect calibration, and
thus incorrect results.
For ISE calibrations, ensure that the calibrator is opened
immediately before the calibration is performed.
d m Calibrators
r To perform an ISE calibration
1
1 Choose Calibration > Status.
2 From the Module drop-down list, choose the desired

module.
3 Choose the desired ISE unit.
4
4 In the Method column, choose the Full option.
f In the Cause column, Manual is displayed and
highlighted in blue.
5 Choose the Save button.

f All ISE modules with a blue highlighted entry in the
Cause column are requested for calibration.
5 Reagents
6 Print the calibration load list.
Roche Diagnostics
7
misplaced ISE calibrators.
Place ISE Standard Low (S1) directly before
ISE Standard High (S2), and ISE Standard High (S3)
after ISE Standard High (S2) on the same rack.
7 Place the calibrators listed on the calibration load list
on calibrator racks.
I Non-barcoded calibrators must be placed on the
assigned rack ID and position.
8
8 Place the calibrator rack into the input buffer.
9 Start the measurement.
10
10 Check the calibration results:
regulations.
• If the calibration has failed, check the alarms and
troubleshoot. Repeat the calibration.
u Related topics
• About manual calibration (474)
• Assigning non-barcoded calibrators to rack
positions (494)
• Loading calibrators for photometric and ISE tests (499)
5 Reagents
Roche Diagnostics
Changing sample probe wash solutions on the ISE module

When the remaining volume of a wash solution bottle is low,
or the expiry date has been exceeded, change the wash
solution bottle.
The instrument monitors the remaining volumes of sample

probe wash solutions by counting down. After changing
sample probe wash solutions, you must reset the initial
filling volume.
The system does not track the expiry date. You must track
expired sample probe wash solutions manually.
You can check the remaining volume of sample probe wash

solutions SmpCln1 and SmpCln2 on the reagent status
report.
u Reagent Status (1397)

r To change a sample probe wash

solution
1 Open the top cover of the module.
2
2 Change the required reagent bottle A or B.
5 Reagents
A B
A D1 SmpCln 1—Sample probe wash solution 1

B D2 SmpCln 2—Sample probe wash solution 2
Roche Diagnostics
3
5
5 Choose the sample probe wash solution that you have
changed.
6 To reset the filling volume countdown, choose the

5 Reagents
Roche Diagnostics
326 Reagents of the c 701 module
Reagents of the c 701 module

The c 701 module requires specific reagents to operate.
In this section
About c 701 module reagents (326)
About c 701 module system reagents (328)
About changing reagent cassettes of the c 701
module (329)
Changing reagent cassettes on the c 701 module (330)
Loading development channel reagents on the c 701
module (334)
Changing reaction cell wash solutions on the c 701
module (337)
Changing sample probe wash solutions on the c 701
module (340)
About c 701 module reagents

Reagents of the c 701 module are either supplied in a
cobas c pack or in various reagent bottles.
Reagent cassettes for c 701 modules
The cobas c pack for c 702/c 701 modules is the principal

reagent cassette. It is ready for use and contains reagent
for 200 to 3000 tests depending on the assay.
A reagent cassette is equipped with an RFID tag on the top.

The instrument scans this RFID tag during reagent
registration.
The RFID tag contains information about the reagent, e.g.:

• Test name, e.g., GLUC3
• Sequence number (unique number for each cassette)
• Lot number
• Expiry date
• Application code number (ACN)
5 Reagents
Reagent cassettes can contain one or 2 reagents.

Applications with 3 pipettings at R1, R2, and R3 require a
separate reagent cassette for the additional reagent. Two
concepts are used to provide the additional reagent:
• Reagent kits
• Special reagents
Roche Diagnostics
Reagents of the c 701 module 327
Reagent kits If an application requires 3 reagents, these reagents can

be supplied in a reagent kit of up to 2 reagent cassettes.
After registration, both reagent cassettes are treated as a
unit.
Special reagents If the additional reagent can be used by multiple assays,

this reagent is called a special reagent.
cobas c pack MULTI The cobas c pack MULTI is an empty reagent cassette for
development channel applications.
Diluents For photometric applications, either water or an NACL

solution is used for dilution of samples:
• The water is deionized water from the water container
of the instrument.
• NACL solution is supplied in a cobas c pack NACL 9%.
Calibrators and QC material
For photometric applications, universal calibrators and

special calibrators are available. A universal calibrator
(e.g., CFAS, CFAS Proteins) can be used for many
applications. Special calibrators cover a few or only one
application.
Likewise, there are universal and special QC materials.
5 Reagents
Roche Diagnostics
About c 701 module system reagents

System reagents of the c 701 module are either supplied in
reagent cassettes or in various reagent bottles.
Reaction cell wash solutions
The instrument uses the following wash solutions for

rinsing and cleaning of reaction cells:
• CellCln1: Cell wash solution 1 (NaOH-D)
• CellCln2: Cell wash solution 2 (acid wash)
A B
A CellCln1: Cell wash B CellCln2: Cell wash

solution 1 (NaOH-D) solution 2 (acid wash)
Sample probe wash solutions

Additionally, SmpCln1 is used in a sample tube or cup on a

wash rack (Rack Pos. 1).
A B
A SmpCln1: Sample B SmpCln2: Sample

probe wash solution 1 probe wash solution 2
5 Reagents
Roche Diagnostics
Wash solutions

reagent probe wash and reaction cell wash:
• NaOHD (D1)
• SMS (D2)
The wash solutions are supplied in reagent cassettes. You

can place the wash solutions on reagent disk A and B.
ECO-D
ECO-D (EcoTergent) is used as a surfactant for the

incubation bath to prevent foaming. You must place the
ECO-D reagent cassette on the outer ring of reagent
disk B.
About changing reagent cassettes of the c 701 module

You must take into account several processes when
changing reagent cassettes on the c 701 module.
Multiple reagent cassettes with the same You can place multiple reagent cassettes with the same
reagent reagent in each reagent disk:
• When the current reagent cassette is empty, the
instrument automatically changes over to the next one
(standby reagent cassette).
5 Reagents
• The order of usage of standby reagents depends on

the order in which reagents were registered. The oldest
reagent is used first. The order of precedence is
indicated in the Reagent Overview dialog box as Current
(active), SB1 (first standby), SB2 (second standby), and
so on.
• If there is a multi-module configuration with the same
module type, the same reagent can be placed on
several modules.
Roche Diagnostics
Reagent kits If one reagent cassette of a reagent kit is empty, the

reagent kit can be broken up. The reagent cassette that
still contains reagent can be used until it is empty. It can be
grouped with another fresh reagent cassette. If both
reagent cassettes in the reagent kit are empty, it is not
necessary to break up the reagent kit.
RFID tag error If an RFID tag of a reagent cassette is unreadable, an

instrument alarm is issued. This reagent cassette cannot
be used on the instrument. The identification cannot be
entered manually.
Reagent registration The instrument automatically registers newly loaded

reagent cassettes when you start the next run (Preparation
mode).
• The reagent probes perform an LLD and a foam
detection for each reagent cassette.
• If foam is detected, the instrument masks the reagent
cassette and issues an alarm. For the cobas c pack
MULTI, no foam detection is performed.
• To calibrate a newly loaded reagent, you must start
reagent registration manually. Only registered reagent
cassettes are displayed on Calibration > Status and are
thus available for calibration.
Reloading reagent cassettes Used reagent cassettes that still contain reagent can be
unloaded and stored according to the storage conditions
(see Instructions for Use).
Within the same instrument, a used reagent cassette can

be reloaded onto another module of the same type. We
recommend not to transfer a reagent cassette from c 702
to c 701 module, or vice versa, due to the information
written on the RFID tag.
Changing reagent cassettes on the c 701 module

If the remaining volume of a reagent cassette is low, or the
reagent has expired, you must replace it.
On the c 701 module, the reagent cassettes must be

loaded and unloaded manually.
5 Reagents

u Bubbles or foam inside a cobas c pack
u Incorrect reagent volume
Roche Diagnostics
j m The instrument or module is in Standby mode.

u Masking a module for background maintenance (775)
r To change reagent cassettes
1
1 To check for any empty reagent cassettes, do one of
the following:
• Choose Overview > .
• Print a reagent load/unload list.
2
2 Open the covers of reagent disk A and B.
A B
A Reagent disk A B Reagent disk B
3
3 If you want to remove one reagent cassette from a
reagent kit, break up the reagent kit first:
• Choose Reagent > Setting.
• Choose the c 701 module.
• Select the desired reagent.
5 Reagents
• Choose the R. Pack Set Information button.

• Choose the Break Up button.
Roche Diagnostics
4
4 Turn the reagent disk and remove the reagent
cassettes to be unloaded.
5 Dispose of the reagent cassettes according to local

regulations.
6 If you later want to reload a reagent cassette that still

contains reagent, store it according to the storage
conditions.
7
7 Carefully unscrew the caps from the new reagent
cassettes.
8
8 Visually make sure that there is no foam inside the
bottles of the reagent cassettes.
9
9 Place new reagent cassettes into empty positions on
the reagent disks:
• Make sure that the white part of the RFID tag faces
5 Reagents
to the left.
• Place reagent kits on the same disk.
• Place ECO-D reagent cassettes on the outer ring of
reagent disk B.
Roche Diagnostics
10
10 Close the cover of the reagent disks.
11
11 If you want to select the reagent cassettes for
calibration before the next run, perform a reagent
registration:
• Choose the Reagent Registration button.
• Select the c 701 module.
• Choose the Execute button.
f The registered reagent cassettes are displayed in
Calibration > Status and can be calibrated.
12
12 Choose Reagent > Setting.
13 From the Module drop-down list, select the c 701

option.
14
14 In the Available Tests column, Type column, R. Pack Lot
ID column, and Exp. Date column of the new reagent
cassettes, make sure that the values are appropriate.
u Related topics
• Unmasking a module (777)
• Performing manual calibration (477)
5 Reagents
Roche Diagnostics

module
To perform development channel tests, you must load the
corresponding reagent cassettes properly.
You can run a development channel application using a

cobas c pack MULTI.
You must register the reagent information, such as test

name and reagent disk position, manually. On Reagent
> Setting, the position of a manually registered reagent is
indicated with a * symbol in the Mark column.
You can only assign one reagent cassette or reagent kit of

a development channel application to each reagent disk
(A or B) of one analytical module.
No reagent changeover operation is performed for

development channel reagents.
q A more detailed description for loading development

channel applications is available on the cobas® e-library.
Refer to the Instructions for Use for the cobas c pack
MULTI. Contact your Roche Service representative for
more information.
j m The development channel application is installed.

m The application parameters are defined.
m The instrument is in Standby mode.
r To load development channel

reagents
1

option.
5 Reagents
Roche Diagnostics
3
3 Select an empty position.
4 Choose the Manual Registration button.
5
5 Choose the test and the type of the reagent.
7 Prepare the reagent in a cobas c pack MULTI according

to the Instructions for Use.
8
8 Visually make sure that there is no foam inside the
bottles of the reagent cassette.
9
9 Place the reagent cassette into the assigned position
on the reagent disks:
• Make sure that the white part of the RFID tag faces
to the left.
• Place reagent kits on the same disk.
5 Reagents
Roche Diagnostics
10
10 Close the cover of the reagent disks.
11
11 If you want to select this reagent cassette for
calibration before the next run, perform a reagent
registration:
f The registered reagent cassette is displayed in
12

option.
14
u Related topics
5 Reagents
Roche Diagnostics
Changing reaction cell wash solutions on the c 701 module

If the remaining volume of a reaction cell wash solution
bottle is low, or the reagent has expired, you must replace
it.
The remaining volumes of reaction cell wash solutions are

monitored, starting from a set initial volume. Whenever a
reaction cell wash solution bottle is replaced, you must
reset the initial volume manually. By resetting the
remaining volume, the wash solution is registered.
! WARNING
Incorrect results may occur due to errors when
replacing reaction cell wash solutions CellCln1 and
CellCln2
The volumes of wash solutions are monitored by counting
down from the initial volume. If the volume counter is not
reset correctly, then this may cause wash solution
shortage, leading to incorrect results.
r Ensure to reset the volume counter after the
replacement of a container.
r Always replace empty containers with new and full
ones.
r Only reset the volume counter after a new container
has been placed.

u Moving parts

5 Reagents
Roche Diagnostics
r To change a reaction cell wash

solution bottle
1
1 Open the front doors of the module.
2
2 Take out the empty reaction cell wash solution bottles.
3 Remove the aspiration tubing.
4 Check the aspiration filter and clean it if necessary.
A Aspiration filter
5
5 Insert the aspiration tubing in a new wash solution
bottle as follows:
• Insert the aspiration tubing so that the end of the
aspiration tubing touches the bottom of the bottle.
• Do not bend the aspiration tubing.
5 Reagents
Roche Diagnostics
6
6 Return the reaction cell wash solution bottles.
7
7 Close the front doors.
8
8 Reset the volume counter of the replaced reaction cell
wash solution bottle:
• Choose the Reset button of the replaced reaction
cell wash solution.
u Related topics
• Cleaning the aspiration filters of the c 701 and c 702
modules (932)
• Unmasking a module (777) 5 Reagents
Roche Diagnostics

module
If the remaining volume of a sample probe wash solution
it.
The remaining volumes of sample probe wash solutions are

monitored by liquid level detection. Whenever a sample
probe wash solution bottle is replaced, you must reset the
initial volume.



solution bottle
1
1 Open the rear cover of the module.
A
5 Reagents
A Rear cover
Roche Diagnostics
2
2 To remove the plexiglass cover, remove the screws.
3
3 Replace the sample probe wash solution bottles.
4 Reattach the plexiglass cover.
A B

5
5 Close the rear cover of the module.
5 Reagents
Roche Diagnostics
6
6 Reset the remaining volume of the replaced sample
probe wash solution bottle:
• Choose the Reset button of the replaced sample
probe wash solution.
u Related topics
5 Reagents
Roche Diagnostics

In this section
module (346)
Loading reagent cassettes on the c 702 module (349)
Unloading reagent cassettes from the c 702 module
Manually selecting reagent cassettes for unloading from
the c 702 module (356)
reagent manager (359)
Emptying the cap waste box of the c 702 module (361)
module (363)
module (367)
module (370)

The cobas c pack for c 702/c 701 modules is the principal

A reagent cassette is equipped with an RFID tag on the top.

The instrument scans this RFID tag during reagent
registration.
5 Reagents
The RFID tag contains information about the reagent, e.g.:

• Lot number
• Expiry date
Roche Diagnostics
Reagent cassettes can contain one or 2 reagents.

Applications with 3 pipettings at R1, R2, and R3 require a
separate reagent cassette for the additional reagent. Two
concepts are used to provide the additional reagent:
• Reagent kits
• Special reagents
Reagent kits If an application requires 3 reagents, these reagents can

be supplied in a reagent kit of up to 2 reagent cassettes.
After registration, both reagent cassettes are treated as a
unit.
Special reagents If the additional reagent can be used by multiple assays,

this reagent is called a special reagent.
cobas c pack MULTI The cobas c pack MULTI is an empty reagent cassette for

of the instrument.
Calibrator and QC material

application.

5 Reagents
Roche Diagnostics

The instrument uses the following reaction cell wash

solutions for rinsing and cleaning of reaction cells:
A B


A B

5 Reagents
Roche Diagnostics
Wash solutions

• NaOHD (D1)
• SMS (D2)
The wash solutions are supplied in reagent cassettes. You

can place the wash solutions on reagent disk A and B.
ECO-D

incubation bath to prevent foaming. You must place the
ECO-D reagent cassette on the outer ring of reagent
disk B.
About changing reagent cassettes on the c 702 module

5 Reagents

so on.
several modules.
Roche Diagnostics
RFID tag error If an RFID tag of a reagent cassette is unreadable, an

instrument alarm is issued. This reagent cassette cannot
be used on the instrument. The identification cannot be
entered manually.
Reagent registration The instrument automatically registers reagent cassettes

that you have loaded during Operation mode. Reagent
cassettes loaded during Standby mode are registered
automatically when you start the next run.
• The reagent probes perform an LLD and a foam
detection for each reagent cassette.
• If foam is detected, the instrument masks the reagent
cassette and issues an alarm. For the cobas c pack
MULTI, no foam detection is performed.
• To calibrate a newly loaded reagent, you must start
reagent registration manually. Only registered reagent
cassettes are displayed on Calibration > Status and are
thus available for calibration.
Loading reagents On the c 702 module, loading is performed automatically:

The rack transfer to this module is stopped. After all
remaining samples in the processing line are pipetted and
the last R3 pipetting is done, the loading process starts.
Reagent cassettes cannot be loaded manually.
Loading limits There are 3 types of limits for loading of reagent cassettes
on the c 702 module:
• General loading limit:
The general loading limit is set to 15 tests per reagent
disk. This limit is not adjustable and not shown in the
user interface. If the remaining number of tests falls
below this limit, a loading trigger is issued. The loading
process starts even if the instrument is in Operation
mode. The required reagent cassettes must be
available in the buffer rotor.
• Yellow loading limit:
If the remaining number of tests falls below the yellow
loading limit, a yellow alarm is issued. Reagent
cassettes of tests with a yellow loading limit alarm
waiting on the reagent manager are loaded directly
during Standby mode or Rack Reception mode. During
Operation mode, the waiting reagent cassette is added
to the loading queue. The reagent cassette will be
5 Reagents
loaded in the next loading session triggered by another

reagent cassette.
• Initial loading limit:
The initial loading limit does not influence loading. The
ratio of the remaining number of tests to this limit is
only printed on the reagent load/unload list.
You can set the yellow loading limit and the initial loading
limit on Utility > System > Reagent Loading Level.
Roche Diagnostics
Loading triggers The reagent manager automatically triggers the loading of

reagent cassettes in the following cases:
Loading trigger Mode

Below general loading limit: Operation or Standby mode
Loading starts if the remaining amount of a reagent cassette falls below the following
limit:
o Assay reagents: 15 tests
o Diluent NACL: 0.54 mL
o NaOHD (D1) and SMS (D2): 1.25 mL
o ECO-D: 10.8 mL
Onboard stability: Operation or Standby mode
Loading starts if the reagent manager onboard stability of a reagent cassette in the
buffer rotor is below or equal to 0.
Open reagent cassette: Operation or Standby mode
Loading starts if you load an open reagent cassette onto the buffer rotor.
Gap between measurements: Operation
Loading starts when all results are output and no analyses are scheduled.
y Loading triggers
Unloading reagents The reagent manager automatically triggers the unloading

of reagent cassettes in the following cases:
• Empty reagent cassettes
• Reagent cassettes with detected foam
• Reagent cassettes of a reagent kit that was broken up
Unloading starts automatically in the following cases:

• If loading is initiated by a loading trigger. The reagent
cassette gripper also unloads reagent cassettes on the
way back from the reagent disks.
• If a time to unload is set (Utility > System > Reagent
Manager Setting) and if the module is not busy (no
sample scheduled for the module and all results are
output).
• When the instrument goes into Standby mode, except
when this action was forced by an abnormal termination
like an alarm.
• When the instrument goes into Rack Reception mode.
Additionally you can unload reagent cassettes manually.

u Manually selecting reagent cassettes for unloading
from the c 702 module (356)
5 Reagents
Unloading reagent kits If one reagent cassette of a reagent kit is empty, the
reagent kit can be broken up. The empty reagent cassette
will be unloaded. The reagent cassette that still contains
reagent can be used until it is empty. It can be grouped
with another fresh reagent cassette. If both reagent
cassettes of a reagent kit are empty, it is not necessary to
break up the reagent kit.
Roche Diagnostics
Within the same instrument, a used reagent cassette can

be reloaded onto another module of the same type. We
recommend not to transfer a reagent cassette from c 702
to c 701 module, or vice versa, due to the information
written on the RFID tag.
Loading reagent cassettes on the c 702 module

On the c 702 module, the reagent cassettes cannot be

loaded manually. The reagent manager automatically
triggers the loading of reagent cassettes. A reagent
cassette gripper transfers the reagent cassettes from the
buffer rotor to the reagent disks.
! WARNING
Incorrect results may occur due to incorrect
replacement of a jammed reagent cassette
If a reagent cassette gets jammed during the loading or
unloading process, do not place it manually into a reagent
disk or replace it by another reagent cassette. There are
A B no RFID readers inside the c 702 reagent disks. Thus, a
misplaced reagent cassette cannot be detected and may
A Buttons for loading B Yellow status indicator lead to incorrect results.
mode
r Remove a jammed reagent cassette manually in
Standby mode.
r Be careful when removing open reagent cassettes from
the instrument. Make sure to wear protective
equipment (such as lab gloves).
r Reload the reagent cassettes via the loading port only.
5 Reagents
Roche Diagnostics
! CAUTION
Delayed results may occur due to blocked return
port
Reagent cassettes that rest on the reagent manager
buffer rotor for several hours may expand due to
increasing reagent temperature and reagent evaporation.
Expanded reagent cassettes may block the return port,
which leads to a system stop and therefore to delayed
results.
r Load all buffered reagent cassettes to the reagent
disks at the end of a work shift.
r Ensure that no reagent cassettes remain on the
reagent manager buffer rotor for several hours.
r If a reagent cassette is blocked and the system stops,
contact your Roche Service representatives.
Status indicator If the yellow status indicator at the control panel is on, one
or more reagent cassettes require a calibration.
Loading modes The reagent manager supports 2 loading modes. The

selected mode remains active until another mode is
selected.
Mode Button Description

Buffering BUFFER o The reagent cassette remains on the buffer rotor until
needed.
o The instrument decides about loading time and target
reagent disk.
Direct AUTO o Loads the reagent cassette as soon as possible.
o The target reagent disk is assigned by the instrument.
A or B o Loads the reagent cassette as soon as possible to disk A
or B.
AUTO o If the module is in Standby mode, the reagent is loaded
A or B immediately.
o During operation, the reagent is loaded as soon as possible.
During loading, the mode on Utility > Maintenance
> Maintenance Monitor changes to Reagent Loading (S.Stop)
mode.
y Loading modes

5 Reagents

j m The instrument is in Standby mode, Operation mode,

Rack Reception mode, or S.Stop mode.
Roche Diagnostics
r To load reagent cassettes
1
the following:
2
2 To select the loading mode, press the corresponding
button.
3 Make sure that the green status indicator on the

loading port is on.
A B
A Buttons for loading B Green status indicator

mode
4
4 Place a reagent cassette onto the loading port with the
test name label facing left.
f The reagent cassette is drawn into the reagent
manager automatically.
5 To load more reagent cassettes, repeat steps 2 to 4.

I Up to 10 reagent cassettes can be loaded within a
loading session. You must load reagent kits within
one loading session. A single reagent cassette of a
reagent kit is ejected at the return port.
5 Reagents
f The green status indicator turns off 10 seconds

after the last loading or when the buffer rotor is full.
f Depending on the loading mode, the reagent
cassette is kept on the buffer rotor, or it is loaded
directly.
Roche Diagnostics
6
6 If a reagent cassette is ejected from the buffer rotor
due to an error (for example, RFID tag is unreadable),
do the following:
• Make sure that the yellow status indicator on the
return port is on.
• Open the transparent cover at the return port.
• Take out the reagent cassette.
• Close the transparent cover.
A B
A Yellow status indicator B Cover of the return

port
7
7 If the yellow status indicator is on, calibrate the reagent
after it has been transferred to a reagent disk.
A Yellow status indicator
8
8 If the instrument is in Standby mode and you want to
select this reagent cassette for calibration before the
next run, perform a reagent registration:
5 Reagents
Roche Diagnostics
9

option.
11
I If you select the Including Reagent Manager check
box, you can also check reagent cassettes on the
reagent manager. In the Position column, they are
labeled with M-1 to M-10.
u Related topics

unloading tray
If a reagent cassette needs to be unloaded, it is
transported to the unloading tray.
! WARNING
no RFID readers inside the c 702 reagent disks. Thus, a
lead to incorrect results.
Standby mode.
5 Reagents

Roche Diagnostics
NOTICE
Instrument damage due to reused reagent caps
Reused caps may be handled incorrectly by the uncapping
mechanism. When a temporarily stored reagent cassette is
loaded again, reused caps may come off accidentally and
get stuck in the mechanism. Furthermore, traces of one
reagent may be left on a cap and contaminate the other
reagent in the cassette.
r Never reuse a reagent cap from the cap waste box.
NOTICE
Instrument damage due to open unloading tray
r Do not open the top cover when the unloading tray is
open.
The left and the right lane of the unloading tray have
different functions:
• Left lane: Accommodates empty reagent cassettes.
• Right lane: Accommodates reagent cassettes
containing reagent (yellow status indicator on).
• If there are no reagent cassettes containing reagents,
the right lane also accommodates empty reagent
cassettes (yellow status indicator off).
A Yellow status indicator

5 Reagents
Roche Diagnostics
r To unload reagent cassettes from the

unloading tray
1
1 Make sure that the green status indicator is on.
A Green status indicator
2
2 Open the hatch door of the unloading tray and pull the
drawer out all the way.
I The drawer must be fully opened. Otherwise the
instrument does not reset the inventory of the
reagent cassettes present on the unloading tray.
3 Unload the reagent cassettes in the following way:

• Remove and dispose of empty reagent cassettes
• Take out filled reagent cassettes.
4
4 Push back the drawer and close the hatch door.
5 Reagents
Roche Diagnostics
5
5 Choose Overview > .
6
6 Make sure that the inventory was reset.
f After removing the reagent cassettes from the
unloading tray, no reagent cassette should be
displayed.

the c 702 module
To transport specific reagent cassettes to the unloading
tray, you can manually select them for unloading.
We recommend keeping reagent cassettes on board until

they are empty.
During operation, the module stops sample processing and

unloads the selected reagent cassettes as soon as the
5 Reagents
reagent manager is available.
Roche Diagnostics
r To manually select reagent cassettes

for unloading
1

option.
3
3 If you want to remove one reagent cassette from a
reagent kit, break up the reagent kit first:
• Select the desired reagent.
• Choose the R. Pack Set Information button.
• Choose the Break Up button.
4
4 Select the desired reagent.
5 Choose the R. Pack Unloading button.
6
6 Choose the Select R. Pack option.

5 Reagents
Roche Diagnostics
8
9
9 Make sure that the selected reagent cassette has been
transferred to the unloading tray.
10 Unload the reagent cassette from the unloading tray.
u Related topics
5 Reagents
Roche Diagnostics

reagent manager
If you want to remove a reagent cassette from the reagent
manager buffer rotor, you can unload it using the return
port.
! WARNING
Standby mode.
NOTICE

5 Reagents
Roche Diagnostics
r To unload a reagent cassette from

the reagent manager
1
the following:
2
2 Choose the desired reagent cassette.
3 Choose the Take Out button.
4
4 Choose the Select R. Pack option.

f The selected reagent cassette is transferred to the
return port. The yellow status indicator at the return
port turns on.
5 Reagents
Roche Diagnostics
6
6 Open the transparent cover at the return port.
7 Take out the reagent cassette.
8 Close the transparent cover.
A B
A Yellow status indicator B Cover of the return

port
Emptying the cap waste box of the c 702 module

If the cap waste box gets full, you must empty it.
The box has a capacity of approximately 100 reagent

caps.
! CAUTION
Skin inflammation caused by to residues of reagent
on reagent caps
Direct contact with reagents or wash solutions may cause
skin irritation or inflammation.
r Exercise the precautions required for handling
laboratory reagents. Be sure to wear protective
equipment (such as gloves).
r Empty the cap waste box periodically. Do not let its
contents overflow or reagent spill over.
NOTICE
5 Reagents

Roche Diagnostics


r To empty the cap waste box
1
2
2 Take out the cap waste box and dispose of the reagent
caps according to local regulations.
3 Return the emptied cap waste box.

I Reagent cassettes are only drawn into the buffer
rotor if the cap waste box is in the correct position.
A Cap waste box

5 Reagents
Roche Diagnostics
4
4 To reset the cap counter to 0, choose the Waste Box
Reset button.
u Related topics

module
! WARNING
Standby mode.
5 Reagents
Roche Diagnostics
! CAUTION
Delayed results may occur due to blocked return
port
Reagent cassettes that rest on the reagent manager
buffer rotor for several hours may expand due to
increasing reagent temperature and reagent evaporation.
Expanded reagent cassettes may block the return port,
which leads to a system stop and therefore to delayed
results.
r Load all buffered reagent cassettes to the reagent
disks at the end of a work shift.
r Ensure that no reagent cassettes remain on the
reagent manager buffer rotor for several hours.
r If a reagent cassette is blocked and the system stops,
contact your Roche Service representatives.

cobas c pack MULTI.
You must manually assign a reagent cassette to an already

installed development channel application. On Reagent
> Setting, the position of a manually assigned reagent is
You can only assign one reagent cassette or reagent kit of

a development channel application to each reagent disk (A
or B) of one analytical module.

A reagent cassette for a development channel application

can be unloaded like usual reagent cassettes. However,
unlike other reagent cassettes, it cannot be reloaded onto
the c 702 module.
If you have already loaded a development channel

reagent, you cannot install more development channel
applications. To install more development channel
applications, you must unload the development channel
reagent first. Afterwards, you can install new development
channel applications and then load the corresponding
reagent cassettes.
5 Reagents

more information.
Roche Diagnostics

m The instrument or module is in Standby mode.

reagents
1

option.
3
3 Choose the Development Channel button.
4
4 Choose the test.
5 Choose the Reserve button.

5 Reagents
Roche Diagnostics
8
8 Select a reagent disk for loading:
• To load the reagent cassette to disk A, press the
A button.
• To load the reagent cassette to disk B, press the
B button.
9 Make sure that the green status indicator at the loading

port is ON.
A B
A Buttons for loading B Green status indicator

mode
10
10 Place the reagent cassette onto the loading port with
the test name label facing left.
f The reagent cassette is drawn into the reagent
manager automatically.
11
11 After the reagent cassette is transferred to the reagent
disk, choose the Reagent Registration button.
12
12 Select the c 702 module.

5 Reagents
Roche Diagnostics
14
u Related topics

it.

reset the initial volume manually. The wash solution is
registered when you reset the remaining volume.
! WARNING
Incorrect results may occur due to errors when
replacing reaction cell wash solutions CellCln1 and
CellCln2
The volumes of wash solutions are monitored by counting
down from the initial volume. If the volume counter is not
reset correctly, then this may cause wash solution
shortage, leading to incorrect results.
r Ensure to reset the volume counter after the
replacement of a container.
r Always replace empty containers with new and full
ones.
r Only reset the volume counter after a new container
has been placed.

5 Reagents
u Moving parts

Roche Diagnostics

solution bottle
1
2
A Aspiration filter
5
bottle as follows:
5 Reagents
Roche Diagnostics
6
6 Replace the reaction cell wash solution bottles.
7
8
cell wash solution.
u Related topics
• Cleaning the aspiration filters of the c 701 and c 702
modules (932)
• Unmasking a module (777) 5 Reagents
Roche Diagnostics

module
it.

initial volume.



solution bottle
1
A Rear cover
5 Reagents
Roche Diagnostics
2
2 To remove the plexiglass cover, remove the screws.
3
A B

4
4 Reattach the plexiglass cover.
5 Reagents
Roche Diagnostics
5
5 Close the rear cover of the module.
A Rear cover
6
u Related topics
5 Reagents
Roche Diagnostics

In this section
module (376)
Loading reagent cassettes on the c 502 module (378)
Unloading reagent cassettes from the c 502 module (380)
module (382)
module (384)
module (386)
Changing the ECO-D bottle on the c 502 module (388)

The cobas c pack for c 502 modules is the principal

A reagent cassette is equipped with a barcode label. The

instrument scans this barcode label when the reagent
cassette is loaded at the loading port and receives the
corresponding parameters from the data manager.
The barcode label contains information about the reagent,

e.g.:
5 Reagents
• Lot number
• Expiry date
Reagent cassettes can contain 1 to 3 reagents.
Roche Diagnostics
cobas c pack MULTI
The cobas c pack MULTI is an empty reagent cassette for

You must register the reagent information, such as test

name and reagent disk position, manually. On Reagent
> Setting, the position of a manually registered reagent is


of the instrument.
A1CD2 is used as a diluent for HbA1c whole blood tests. It

is also supplied in a cobas c pack.
Calibrator and QC material

application.

5 Reagents
Roche Diagnostics

The instrument uses the following reaction cell wash

solutions for rinsing and cleaning of reaction cells:
A B



A B

5 Reagents
Roche Diagnostics
Wash solutions

• NaOHD (D1, additionally for the maintenance action
wash reaction parts)
• SMS (D2)
• SCCS (D3, additive used for reaction cell carryover
prevention in long HbA1c batches)
ECO-D

incubation bath to prevent foaming.
About changing reagent cassettes on the c 502 module

5 Reagents

so on.
several modules.
Roche Diagnostics
Reagent registration New reagent cassettes are registered at the reagent

preparation station after they have been loaded at the
loading port.
If the reagent cassette currently being scanned has not

been on the instrument before, the instrument proceeds
with the following actions:
• By reading the reagent cassettes barcode, the
instrument checks the availability of the corresponding
test application.
• The reagent cassette piercer punctures the reagent
bottle caps.
• The reagent volume for each newly loaded reagent
cassette is checked via a barcode.
• For development channel reagents, an ICVC is
performed by default. The pressure sensor at the
R1 pipetter probe of the c 502 module performs the
ICVC.
(see Instructions for Use). A used reagent cassette can be
reloaded onto the same or another c 502 module within
the same instrument.
With every pipetting out of a reagent cassette, the

instrument counts down the initial number of available
tests for this reagent cassette. The instrument stores the
number of available tests for up to 15 000 reagent
cassettes.
You can unload a reagent cassette and reload it later. The

instrument recognizes the reagent cassette and continues
the test count at the point where the reagent cassette was
unloaded. The reagent volume of the reagent cassette
must remain unchanged while the reagent cassette is not
on the instrument.
5 Reagents
Roche Diagnostics
Loading reagent cassettes on the c 502 module

! CAUTION
Personal injury due to contact with reagent
cassette loading mechanism
If you insert your fingers into the loading port, the
instrument may mistake them for a reagent cassette.
During unloading, a reagent cassette may hit your fingers.
r The top cover must be closed and locked while the
instrument is loading reagent cassettes.
r Leave the preparation table closed, except when
loading reagent cassettes or when manually unloading
reagent cassettes from Reagent > Setting.
r Do not insert anything other than reagent cassettes
into the loading port.
On the c 502 module, a management system loads and

unloads reagent cassettes automatically. A reagent
cassette gripper transfers reagent cassettes from the
loading port to the reagent disk. Empty reagent cassettes
are automatically transferred to the disposal port.
The instrument scans the barcode label when the reagent

cassette is loaded. If the parameters cannot be received
from the data manager, an instrument alarm is issued.

j m The instrument is in Standby mode, Operation mode,

Rack Reception mode, or S.Stop mode.
5 Reagents
Roche Diagnostics
r To load reagent cassettes
1
the following:
2
2 To access the loading port, open the preparation table
at the front of the c 502 module.
3
3 Place the reagent cassette right in front of the loading
port with the barcode label facing to the right.
4 To load reagent cassettes, do the following:

• Make sure that the top cover is closed and locked
before loading reagent cassettes.
• Slide the reagent cassette all the way into the
loading port until you sense a resistance.
f The reagent cassette is pulled into the reagent
preparation station where the module automatically
performs the reagent registration.
The reagent cassette piercer punctures the reagent
bottle caps. The reagent cassette gripper transfers
5 Reagents
the reagent cassette to the reagent disk.
q If a reagent cassette barcode is facing the wrong

direction or the barcode is unreadable, a barcode read
error occurs. In this case, the reagent cassette is
rejected and not registered but pushed out of the
loading port.
Roche Diagnostics
5 To load more reagent cassettes, do the following:

• Wait until the reagent cassette gripper has
transferred the current reagent cassette to the
reagent disk.
• If a reagent cassette has been pushed out of the
loading port, wait for 5 seconds or more before
placing another reagent cassette into the loading
port. Otherwise, the instrument does not process
the reagent cassette.
• Repeat steps 3 to 4.
u Related topics

To transport a reagent cassette to either the loading port
or the disposal port, you can select it for unloading.
The c 502 module supports 2 unloading options:

• Dump option: Sends an empty reagent cassette to the
disposal port. If you use the Dump option to unload a
partly filled reagent cassette, the unloaded reagent
cassette cannot be reloaded.
• Unload option: Sends a partly filled reagent cassette to
the loading port. Use the Unload option if you want to
reload the reagent cassette later.


5 Reagents
Roche Diagnostics
r To unload reagent cassettes
1

option.
3
3 Select the desired reagent.
5
5 Choose one of the following unloading options:
• To send the reagent cassette to the loading port,
choose the Unload option.
• To send the reagent cassette to the disposal port,
choose the Dump option.

f If you choose the Unload option, wait at least
5 seconds after the reagent cassette is pushed out
of the loading port before you place any reagent
cassette into the loading port.
7
7 Remove the reagent cassette from the loading port.
5 Reagents
Roche Diagnostics
8
8 When the disposal shaft becomes full, remove and
dispose of the reagent cassettes from the disposal port
I The disposal shaft has a capacity of 10 reagent
cassettes.
u Related topics
A Disposal port for reagent cassettes

module

cobas c pack MULTI.
You must manually assign a reagent cassette to an already

installed development channel application. On Reagent
> Setting, the position of a manually assigned reagent is

If you have already loaded a development channel

reagent, you cannot install more development channel
applications. To install more development channel
applications, you must unload the development channel
reagent first. Afterwards, you can install new development
channel applications and then load the corresponding
reagent cassettes.
5 Reagents

more information.
Roche Diagnostics


reagents
1

option.
3
3 Choose the Development Channel button.
4
4 Choose the test.
5 Choose the Reserve button.

8 Load the reagent cassette.
u Related topics
5 Reagents
Roche Diagnostics

it.
! CAUTION
Personal injury due to contact with instrument
mechanism
Contact with the syringes behind the front door may result
in personal injury.
r Do not touch any parts of the instrument except those
parts specified.
r Carefully observe all instructions given in this manual.

reset the initial volume manually. By resetting the
remaining volume, the wash solution is registered.



solution bottle
1
1 Open the front door of the module.
5 Reagents
Roche Diagnostics
2
4
5
bottle as follows:
6
6 Replace the reaction cell wash solution bottles.
5 Reagents
Roche Diagnostics
7
7 Close the front door.
8
cell wash solution.
u Related topics
• Cleaning the aspiration filters of the c 502
module (1004)

module
it.

5 Reagents
initial volume.

Roche Diagnostics


solution bottle
1
A B

2
2 Close the top cover of the module and lock it.
5 Reagents
Roche Diagnostics
3
3 WARNING! Incorrect results due to wash solution
shortage. If you reset the remaining volume counter
without replacing the wash solution bottle, a wash
solution shortage may occur, leading to sample
carryover and incorrect results. Ensure that a new wash
solution bottle is in place before resetting the
remaining volume.
u Related topics
Changing the ECO-D bottle on the c 502 module

If the remaining volume of a ECO-D bottle is low, or the
The remaining volume of ECO-D is monitored by liquid level

detection. Whenever a reagent bottle is replaced, you
must reset the initial volume.

r To change an ECO-D bottle
1
1 Replace the ECO-D bottle.
5 Reagents
A ECO-D bottle
Roche Diagnostics
2
3
3 Reset the volume counter of the replaced ECO-D
bottle:
• Choose the Reset button of the ECO-D bottle.
u Related topics
5 Reagents
Roche Diagnostics
390 Reagents and consumables of the e 801 module
Reagents and consumables of the e 801

module
The e 801 module requires specific reagents and
consumables to operate.
In this section
About cobas e flow tests on the e 801 module (391)
About multi-application tests on the e 801 module (398)
About e 801 module reagents and consumables (399)
About e 801 module system reagents (401)
module (403)
Changing reagent cassettes on the e 801 module (403)
Linking pretreatment and assay reagent cassettes on the
e 801 module (425)
Linking reagent cassettes as part of linked kits on the
e 801 module (427)
Changing system reagents on the e 801 module (428)
Replacing consumables and changing solid waste boxes on
5 Reagents
Roche Diagnostics
Reagents and consumables of the e 801 module 391
About cobas e flow tests on the e 801 module

cobas e flow tests are the automated combination of
immunology tests on e 801 modules. On previous modules,
these combinations had to be done in manual steps.
cobas e flow tests are a feature of the e 801 module in

combination with the data manager.
In this section
About basic cobas e flow test concepts of the e 801
module (391)
About types of cobas e flow tests on the e 801
module (393)
About calibration and QC for embedded tests on the e 801
module (395)
Overview of reagent status information for embedded
tests on the e 801 module (396)
About coordinating work on the e 801 module and the data
manager (398)
About basic cobas e flow test concepts of the e 801 module

cobas e flow is a feature of the data manager and the
e 801 module. cobas e flow combines a sequence of
immunology tests automatically, which you must combine
manually on other systems.
cobas e flow tests cobas e flow tests are a pre-defined combination of

conventional immunology tests.
For example, this combination can be one of the following:

• A sequence of different tests based on previously
determined results.
• A redundant measurement of one parameter with the
same immunology test.
• A redundant measurement of one parameter with
2 different tests.
Generally, it is possible to combine tests manually in this

manner with any system. However, combining tests
5 Reagents
manually is error prone and time consuming.
With cobas e flow tests, tests can be combined

automatically instead of manually, by using software
algorithms.
Roche Diagnostics
Essential parts of a cobas e flow test are the following:

• The algorithm when to run which immunology test, for
example, in a specific combination with other tests or
based on previous results
• The algorithm how to calculate the final result that is
reported from the individual immunology tests
cobas e flow tests are ordered from and managed via the
data manager. The involved immunology tests are
performed automatically on the e 801 module.
Embedded tests The immunology tests that are performed on the e 801
module as part of cobas e flow tests are called embedded
tests.
Embedded tests have the following characteristics:

• Embedded tests measure the same parameter, apply
the same test principle, and use the same reagent
cassette as the regular test.
• Embedded tests have individual ACNs differing from the
corresponding regular tests.
• You cannot order embedded tests manually on the
control unit of the e 801 module. Instead, you order
cobas e flow tests on the data manager. Then the data
manager orders embedded tests on the e 801 module
automatically.
• For certain embedded tests, there is no corresponding
regular test available. It is not possible to process such
an embedded test without cobas e flow.
5 Reagents
Roche Diagnostics
About types of cobas e flow tests on the e 801 module

The different types of cobas e flow tests combine the
involved immunology tests in different ways.
General example of a cobas e flow test A cobas e flow test is a sequence of tests based on
previously determined results.
• On the data manager, a negative result finishes this

FREDVHÁRZWHVW cobas e flow test and is reported as the main result. A
positive test result automatically starts further
embedded tests.
(PEHGGHGWHVW¬$ • The main result is calculated on the data manager.
• All tests are summarized for the result report on the
data manager. However, only relevant results are
Neg/Pos reported. For those tests whose results are not
reported, only data alarms are shown.
+RVW EmbeddedWHVW¬%
EmbeddedWHVW¬&
Main result
Subresult:
• 7HVW$
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Main result
Subresults:
• 7HVW¬$
• 7HVW¬%
• 7HVW¬&
Linked tests for cobas e flow tests Some embedded tests that are performed as part of
cobas e flow tests use the same reagent cassette.
Therefore, these tests are dependent on one another and
are called linked tests. Linked tests are pipetted in strict
sequence. If there is a failure of one linked test, all linked
tests are repeated.
5 Reagents
Roche Diagnostics
cobas e flow duplicate repeat tests With duplicate repeat tests, one embedded test is
performed again for result confirmation.
• On the data manager, a negative result finishes this

FREDVHÁRZGXSOLFDWHUHSHDWWHVW cobas e flow test and is reported as the main result. A
positive result automatically starts a duplicate
repetition.
(PEHGGHGWHVW¬$ • All tests are summarized for the result report on the
reported. For those tests whose results are not
Neg/Pos
+RVW EmbeddedWHVW¬$
EmbeddedWHVW¬$
Main result
Subresult:
• 7HVW$
+RVW
Main result
Subresults:
• 7HVW¬$
• 7HVW¬$
• 7HVW¬$
cobas e flow duo tests A cobas e flow duo test is an independent measurement of
the same parameter using different tests.
• The cobas e flow duo test uses a linked kit, where

FREDVHÁRZGXRWHVW multiple reagent cassettes are linked and measured
together. The main result is calculated by the data
manager, based on the formula in the cobas e flow.
Embedded test A
Embedded test B
• All tests are summarized for the result report on the
Calculate main result
reported. For those tests whose results are not
Host
Main result
Subresults:
• Test A
• Test B
Linked kits for cobas e flow duo tests Linked kits refer to cobas e flow duo tests. Linked kits are
unrelated to linked tests.
5 Reagents
The applications and reagent cassettes of the involved

embedded tests are linked on the e 801 module. Reagent
cassettes that are to be linked come in one pack and have
the same lot number.
Linked kits are pipetted in strict sequence. If there is failure

of one test, all tests must be repeated with the same
pipetting sequence.
Roche Diagnostics
If you calibrate or perform QC measurement on one

embedded test that is part of the same linked kit, you must
calibrate and perform QC measurement on all embedded
tests that are part of the same linked kit.
u Linking reagent cassettes as part of linked kits on the
e 801 module (427)
About calibration and QC for embedded tests on the e 801 module

Calibration and QC for embedded tests is not usually
measured, but copied from their regular-test counterparts
or from another embedded test.
Principle Embedded tests are an exact copy of their regular-test

counterparts. The embedded test uses the same reagent
cassette and the same measurement protocol as its
regular-test counterpart. Hence, there is no need for
individual calibration and QC of an embedded test that has
a regular-test counterpart.
The calibration curve and QC results can simply be copied

from the regular test to the embedded test. This process is
called copy calibration and copy QC.
In addition, there are also embedded tests that have no

regular-test counterparts. For embedded tests with no
regular-test counterparts, you must perform individual
calibration and QC.
There can also be multiple embedded tests that use the

same reagent cassette and the same measurement
protocol. These associated embedded tests that have no
regular-test counterparts also employ copy calibration
and copy QC. Only for one, not for all of these associated
embedded tests, a calibration and QC measurement has to
be performed.
Execution of copy calibration and copy QC The regular test takes on the role of the master
application. Or in the case of the associated embedded
tests with no regular-test counterpart, one embedded test
takes on the role of the master application.
After calibration has been performed, the control unit

5 Reagents
copies the calibration data from the master application to

the additional applications. For QC results, it is the data
manager that copies the QC results from the master
application to the additional applications.
The control unit does not check the calibration data or QC

result for additional applications, only for the master
application.
Roche Diagnostics
Copy calibration
1 2 3
Up to four (4) applications &opy calibration data to
&alibration measurement
assigned to reagent cassette additional applications
Master application Master application

$GGLWLRQDODSSOLFDWLRQ¬ $GGLWLRQDODSSOLFDWLRQ¬
w Dependencies of copy calibration—analogous for copy QC
The roles of master application and additional application

are predefined in the application file on the control unit.
You cannot configure these roles.
You must order calibrations and QC measurements for all

embedded tests individually. You cannot order calibrations
and QC measurements for cobas e flow tests.
Overview of reagent status information for embedded tests on the e 801

module
Some menus display special status information regarding
embedded tests.
Reagent > Setting Embedded tests that are linked tests or that are part of a
linked kit are marked.
In the Mark column, an @ mark is displayed for these tests.

5 Reagents
Roche Diagnostics
Reagent > Setting > R. Pack Set Information When you choose any test with an @ mark and then choose
the R. Pack Set Information button, the R. Pack Set
Information dialog box is displayed.
For the selected test, the R. Pack Set Information dialog

box lists all linked tests or all tests that are part of the
same linked kit.
Reagent Overview > Detail For linked tests, the Detail dialog box lists the up to 4
embedded tests in the Calibration list.
The R.Pack entry and Lot entry in the first line indicate that
this test is the master application that actually performed
the calibration measurement.
The Copied entries in the other lines indicate that these

tests are additional applications and that their calibrations
are copy calibrations.
Each test that is listed in the Calibration list can require an

individual pretreatment. Therefore, the PT-Link list shows
up to 4 pretreatment reagent cassettes that are linked to
this selected assay reagent cassette.
For linked kits, the Detail dialog box lists the test for the
selected reagent cassette in the Calibration table. If
applicable, the PT-Link list displays the linked pretreatment
reagent cassette.
The Linked Kit list displays the up to 9 other embedded

tests that are part of the same linked kit.
u About reagent statuses (307)
Linking pretreatment and assay reagent cassettes on
5 Reagents
Roche Diagnostics
Calibration > Status In the Calib. Type column, R. Pack or Lot is displayed for
regular calibrations, or a blank space is displayed for ISE
calibrations.
For copy calibrations, Copy is displayed in the Calib. Type

column.
About coordinating work on the e 801 module and the data manager
To perform cobas e flow tests, you must coordinate your
work on the e 801 module and control unit, and on the data
manager.
Tasks on the e 801 module and control unit On the control unit, you cannot influence orders of
embedded tests that you ordered on the data manager.
Also, the control unit does not display results for
embedded tests. On the e 801 module, it is your
responsibility to keep embedded tests operational.
Therefore you must ensure installation of required
embedded tests, and valid calibrations and QC results for
those tests that have the master-application role.
u About calibration and QC for embedded tests on the
e 801 module (395)
Tasks on the data manager If embedded tests are not installed, or have an invalid
calibration or invalid QC results, orders for cobas e flow
tests on the data manager are not processed. You must
cross-check on the control unit and on the data manager
for required embedded tests to keep those tests
operational.
About multi-application tests on the e 801 module

Multi-application tests use the same reagent cassette, but
with different measurement protocols from different
applications.
5 Reagents
General concept of multi-application tests One typical deployment is the measurement of one
parameter for 2 purposes:
• Measurement with a regular measurement protocol for
routine samples
• Measurement with a sped-up measurement protocol for
STAT samples
Roche Diagnostics
However, the tests that are part of one multi-application

test can be ordered independently and are performed
independently.
Up to 4 applications can be part of 1 multi-application test.

The different applications have different ACNs.
Reagent status information Individual calibration and QC are necessary because of the
different measurement protocols.
When you select a segment from the representation of the

reagent disk in the Reagent Overview dialog box, the Detail
dialog box is displayed. The Detail dialog box lists the up to
4 regular tests in the Calibration list.
About e 801 module reagents and consumables

Reagents of the e 801 module are either supplied in
Reagent cassettes for e 801 modules The cobas e pack green for e 801 modules is the principal
reagent cassette.
A reagent cassette for e 801 modules is ready for use and

C B
consists of 3 capped reagent bottles. The reagent
cassettes are available with 2 filling volumes: S for
100 tests and L for 300 tests. The casing of the reagent
cassette is the same size for filling volumes S and L. The
number of bottles is the same for every reagent type. Not
every bottle must be filled, one or 2 bottles can be empty.
The RFID tag on the reagent cassette contains information

about the reagent, e.g.:
5 Reagents
• Test name, e.g., TSH

• Lot number
• Expiry date
A
The following reagent types are provided in reagent
A Reagent 1 (R1) C Microbeads
cassettes. Not every bottle of the 3 must be filled.
B Reagent 2 (R2)
Roche Diagnostics
Reagent type Configuration of reagent cassette

Assay Three filled reagent bottles
Diluent Three filled reagent bottles
(2 half-full, one full because of two-
shot pipetting)
Pretreatment (sample One or 2 filled reagent bottles
pretreatment used for
specific immunology
tests)
y Reagent types in reagent cassettes
Microbeads are necessary for every immunology test,

irrespective of reagent 1 and reagent 2. Microbeads are
always supplied in assay reagent cassettes.
Diluents Dilution of samples is necessary if the analyte

concentrations exceed the measuring range of the
respective immunology test method. In addition, general
predilution of samples is specified for some immunology
tests.
Examples of diluents are:

• Diluent Universal
• Diluent MultiAssay
u Instructions for Use of the respective application
Calibrators and QC material On the e 801 module, there are calibrators available that
are specific for a single immunology test. Also, there are
multi-calibrators available that can be used for multiple
immunology tests.
Some immunology tests use inpack calibrators. Inpack

calibrators are delivered within the reagent package.
For QC, there is QC material that is specific for only a

single immunology test and QC material that covers
multiple immunology tests.
Calibrators and QC material can sometimes be provided in

barcoded vials. Often calibrators and QC material are
provided as a lyophilisate. You dissolve the lyophilisate and
5 Reagents
transport it into a vial that you barcode yourself.
Barcodes can be single barcodes or dual barcodes for

different systems.
For details, refer to the Instructions for Use of the

respective calibrator or QC material.
u Instructions for Use of the respective assay reagent
About calibration of immunology tests (502)
About calibration of tests on the e 801 module (504)
Roche Diagnostics
Consumables
Single-use tips, called AssayTips, are used for sample

pipetting. Single-use reaction vessels, called AssayCups,
are used for incubating.
AssayTips and AssayCups are called consumables and are

provided to the instrument in magazines. The magazines
are specific for the e 801 and the e 602 module,
respectively, and are not interchangeable.
About e 801 module system reagents

The e 801 module requires system reagents for supportive
processes of the measurements.
The e 801 module uses the following system reagents:

• ProCell II M solution
• CleanCell M solution
• PreClean II M solution
• ISE Cleaning Solution/Elecsys SysClean (not on the
instrument, used for maintenance only)
A B C
A Two bottles of C Two bottles of
PreClean II M solution CleanCell M solution
B Two bottles of
ProCell II M solution
ProCell II M solution The instrument requires ProCell II M solution for the

following purposes:
5 Reagents
• Conditioning of the electrodes

• Transport of the assay reaction mixture
• Washing of the microbeads
• Signal generation
ProCell II M bottles are equipped with an RFID tag, which

contains the lot number and expiry date.
Roche Diagnostics
CleanCell M solution The instrument requires CleanCell M solution for the

following purposes:
• Cleaning the tubing system and measuring cells
• Cleaning the reagent probes during analysis
PreClean II M solution The instrument requires PreClean II M solution to remove

potentially interfering substances from the microbeads.
On the e 801 module, most tests require this additional

step if not stated otherwise in the Instructions for Use of
the respective assay reagent.
ISE Cleaning Solution/Elecsys SysClean You use SysClean solution for cleaning the ECL flow path
and the pre-wash area in a maintenance action.
SysClean solution is not permanently on the instrument.

u Cleaning the ECL and pre-wash flow paths of the e 801
module (1080)
ProCell II M CleanCell M PreClean II M

Number of tests per bottle ≥ 1000 ≥ 800 ≥ 2000
Dead volume 50 mL 50 mL 50 mL
y Specifications of system reagents
! WARNING
Incorrect results may occur when using expired
system reagents
Results based on expired system reagents are not reliable.
r Do not use system reagents that have exceeded their
expiry date or onboard stability.
5 Reagents
Roche Diagnostics
About changing reagent cassettes on the e 801 module

changing reagent cassettes on the e 801 module.
Changing reagent cassettes on the e 801 module

When the remaining volume of a reagent cassette is low, or
the expiry date has been exceeded, you change the
reagent cassette to ensure correct measurement.
In this section
module (404)
About the reagent manager of the e 801 module (408)
List of status indicators and button statuses on the e 801
module (411)
Changing more than 5 reagent cassettes on the e 801
module in Standby mode (413)
Changing up to 5 reagent cassettes on the e 801 module
in Standby mode (416)
Changing reagent cassettes for later processing on the
e 801 module in Operation mode (419)
Changing reagent cassettes on the e 801 module for
immediate processing in Operation mode (422)
5 Reagents
Roche Diagnostics

You can change reagent cassettes in Standby mode or
Operation mode. The workflow provides you with an
overview of the different loading modes.
Changing reagent cassettes of the e 801 module
Selecting for unloading
Automatically selected
Select manually (only in Standby mode)
Changing reagent cassettes
Standby status Operation status
Initial loading mode Initial loading mode Preventive loading mode Fast loading mode
0RUHWKDQÀYHUHDJHQW 8SWRÀYHUHDJHQW
Later processing Immediate processing
cassettes cassettes
The system unloads all reagent cassettes automatically.

When you change reagent cassettes, you must take out all
reagent cassettes that the system unloads. In the same
task, you load all required reagent cassettes.
In Operation mode, loading has priority over unloading. In

order not to interrupt operation, the instrument allows you
to load reagent cassettes without unloading reagent
cassettes as far as possible.

5 Reagents
u Reagent loader (e 801 module)
Roche Diagnostics
! CAUTION
Personal injury due to contact with the reagent
loader
Your fingers may be pinched between the moving reagent
loader and the cover.
r Do not touch the reagent loader and do not insert your
fingers or other body parts into the reagent loader
while it is moving up or down. In case of an electrical
power failure, the reagent loader may descend by its
own weight.
NOTICE
Instrument damage due to foreign substances
Foreign substances, such as screws, may damage the
reagent loader.
r Only put reagent cassettes into the loading port.
r Ensure that the loading port is clean and free from
foreign substances.
NOTICE
Instrument damage due to incorrectly oriented
reagent cassettes
If you load a reagent cassette the wrong way around, the
e 801 module may be damaged.
r Load the reagent cassette as shown on the label of the
reagent loader.
You can remove and later reuse reagent cassettes on any

e 801 module of the same system if the reagent cassette
has not been linked to another reagent cassette in any
way. However, you cannot reuse a reagent cassette on
another system. Storage conditions of used reagent
cassettes are described in the Instructions for Use of the
respective immunology test.
q The Very Initial Bead Mixing (VIBM) on e 801 modules

is performed only once on every reagent cassette. The
VIBM is valid for 4 months. When the VIBM has expired after
5 Reagents
4 months, you cannot reuse the reagent cassette anymore

on any e 801 module.
u Linking pretreatment and assay reagent cassettes on

e 801 module (427)
Roche Diagnostics
If a reagent is empty, missing, or below a set volume level,

the Reagent Preparing button and the Reagent Overview
button change their color to red, yellow, or purple.
u Defining the reagent warning levels (310)

u Printing a load list and preparing the reagents (288)
q The reagent storage is cooled at 5–10 °C (41–50 °F).

To preserve the reagent’s onboard stability, you load the
reagents immediately after taking them from the
refrigerator.
RFID reading Each reagent cassette is equipped with an RFID tag. Five
RFID readers are integrated in the reagent manager for
reading RFID tags while loading reagent cassettes. The
instrument receives corresponding parameters from the
data manager. Another RFID reader is located in the
reagent storage. This RFID reader only reads and does not
write the RFID tags while processing reagent cassettes in
Operation mode.
q If an application is updated with a new e-file version,

unload all relevant reagent cassettes, select partial
overwrite or overwrite and load e packs again. Do not
delete the application because the unloaded e packs
cannot be reused.
Background: Initial Volume Check will only be performed
with new (unregistered) e packs, hence the remaining
volume and test count do not match after reloading.
Priority of reagent cassettes If there are multiple reagent cassettes for one application
on an e 801 module, these reagents are used up in the
following order:
1. Current reagent cassette
2. Reagent cassette with the same lot number as the last
used reagent cassette
3. Reagent cassette of lot that expires first
4. Within the same lot: The reagent cassette with the
5 Reagents
oldest registration time

5. Within the same lot: Reagent cassette with the least
remaining volume
As a rule, the older reagent cassette takes precedence

over the newer one.
Roche Diagnostics
Registration, initial processing, When reagent cassettes are loaded, reagent registration is
and remaining volume control performed automatically. The reagent is processed in the
following way:
The reagent probe performs a liquid level detection and air

bubble or foam detection.
In Operation mode, the instrument counts every pipetting

out of this reagent cassette. Thus, the reagent cassette’s
initial number of remaining tests is counted down.
If the total number of available tests for an application on

one module is lower than a defined limit, the software can
be configured to issue an alarm. Therefore, the yellow and
purple warning levels must be set for each application.
When the number of available tests is 0, a red alarm is
issued. The test is masked unless another reagent cassette
is available as a standby reagent or on a second module.
However, if you unload a used reagent cassette, the

reagent cassette expires 4 months after first registration.
After that, you cannot load the cassette again.
If you place reagent cassettes in the fridge, make sure that

they are closed completely.
A reagent cassette that is not linked with another reagent

cassette can be transferred to another e 801 module that
is connected to the same core unit.
q A used reagent cassette can be loaded onto another

module within the same system.
5 Reagents
Roche Diagnostics
About the reagent manager of the e 801 module

The reagent manager automatically loads and unloads
reagent cassettes into and from the reagent disk. This is
possible during Standby mode or Operation mode.
E F G
A B C D
A Loading ports E Cap pre-opener

B Reagent loader F Status indicator for each loading port
C Reagent storage G Load button
D Reset button
Reagent loader The reagent loader moves up and down to transport

reagent cassettes into the reagent storage.
5 Reagents
Roche Diagnostics
Status indicators The 5 status indicators show the status of the reagent
cassettes in the respective loading port.
Green The reagent cassette can be registered.
Flashing red The reagent cassette can not be

registered at the moment. You must
remedy first.
Red The reagent cassette is invalid (e.g.,

empty or expired). Dispose of the
reagent cassette according to local
regulations in any case.
If a status indicator is flashing red, an alarm message is

issued explaining the problem.
If all 5 status indicators are flashing red simultaneously,

you have less than 30 s to load and unload.
e 801 module (411)
Load button You can raise and lower the reagent loader by pressing the
load button. You can choose whether to process reagent
cassettes immediately or later, depending on how long you
press this button.
Duration Instrument mode Resulting instrument behavior

Press the button for less than Standby Initial loading mode
2 seconds o The reagent cassettes are transported to the reagent disk
but processed later.
o The reagent loader automatically moves up again and you
can load more reagent cassettes.
o You can repeat this procedure multiple times.
o To finish loading reagent cassettes, press the load button
for more than 2 seconds.
Operation Preventive loading mode
o The reagent loader moves down but the reagent cassettes
stay in the reagent loader until an empty sampling cycle is
available.
o When at least 3 empty sampling cycles are available, the
reagent cassettes are transported into the reagent disk
and processed.
o The reagent loader stays lowered.
Press the button for more than Standby Initial loading mode
2 seconds o The reagent cassettes are transported to the reagent disk
and processed as soon as possible.
o If you have successively loaded other reagent cassettes
5 Reagents
before, by pressing the load button for less than 2

seconds, these reagent cassettes are processed now as
well.
Operation Fast loading mode
o The reagent loader moves down and the current sampling
cycle is interrupted.
o Reagent cassettes are transported into the reagent disk
and processed as soon as possible.
y Loading reagent cassettes with the reagent manager
Roche Diagnostics
The LED of the load button indicates the position of the

reagent loader:
Off The reagent loader is up or down.
Flashing The reagent loader is down or moving.

e 801 module (411)
Loading ports To load a reagent cassette, you push it through one of the
5 loading ports into the reagent loader. To unload a
reagent cassette, you pull it out of the reagent loader and
through the respective loading port.
You can insert any reagent cassette into any loading port
in any order. The right loading port has the highest loading
priority. The higher the loading port number, the lower is
the loading priority.
q After you have loaded or unloaded reagent cassettes

into or from the loading ports, press the load button as
soon as possible. Keep the exposure to room temperature
for the reagents inside the reagent storage short.
Cap pre-opener When loading a reagent cassette, the cap pre-opener

opens the bottle caps to soft-close position. Caps in soft-
close position minimize reagent evaporation.
When unloading a reagent cassette, the cap pre-opener

cannot fully close the caps. If you want to store unloaded
reagent cassettes for later use, fully close the caps
manually.
Loading time and reset button To keep the reagent’s exposure to room temperature
short, the reagent loader is programmed to move down
automatically after 120 s. By pressing the reset button,
you can extend the loading time for 2 more minutes.
The status indicator of the reset button indicates the

remaining time:
On You have 120 s counting down to load

and unload.
5 Reagents
Flashing You have 30 s counting down to finish

loading and unloading or to press the
reset button to extend the loading time.
Off The reagent loader is down or moving.
u Related topics
• Reagent manager of the e 801 module (188)
Roche Diagnostics
List of status indicators and button statuses on the e 801 module

The status indicators and buttons can indicate various
statuses. Some statuses are only informative and do not
require you to react.
Most statuses of the status indicators require you to react.

The statuses of the load button are only informative. The
statuses of the reset button suggest possible actions.
LED/button Color Meaning

Status Green When loading, the reagent cassette was accepted.
indicators Reagent cassette was selected manually for unloading. The
reagent cassette still contains reagents and can be loaded
again.
Store the reagent cassette in the refrigerator according to the
Instructions for Use for later use. If you dispose of the reagent
cassette, do so according to local regulations.
Yellow Reagent cassette is invalid due to the following reasons:
o Reagent cassette is expired
o Reagent cassette is empty
Check the alarm descriptions for remedy if an alarm has been
issued. If no alarm has been issued, this means the unloaded
reagent cassette is empty. Dispose of the reagent cassette
according to local regulations in any case.
Flashing yellow Reagent cassette cannot be registered due to the following
reasons:
o Reagent cassette loaded in wrong orientation
o No application for the test installed
o RFID tag unreadable
o Malfunction of loading port or RFID reader
o Parameters for the test cannot be obtained
o No communication to data manager
o Reagent cassette already registered on another
instrument
o No positions available in the reagent disk
o Air bubbles or foam detected
Check the alarm descriptions for remedy.
Unload inversely loaded reagent cassettes from the reagent
loader immediately. The reagent loader will move down after
2 minutes. Inversely loaded reagent cassettes might damage
the instrument.
All 5 LEDs flashing 90 s have passed since the reagent loader has moved up.
yellow In 30 s, the reagent loader moves down to keep the reagent’s
exposure to room temperature short.
To extend the loading time, press the reset button, or to
register the loaded reagent cassettes, press the load button.
Check the alarm descriptions for remedy.
5 Reagents
Load button Flashing green The reagent loader is moving up or down.
Reset button Red The reagent loader is raised. You can load reagent cassettes.
Flashing red 90 s have passed since the reagent loader has moved up.
In 30 s, the reagent loader moves down to keep the reagent’s
exposure to room temperature short.
To extend the loading time, press the reset button, or to
register the loaded reagent cassettes, press the load button.
y Statuses of status indicators, load button, and reset button on the e 801 module
Roche Diagnostics
Manually selecting reagent cassettes for unloading from the e 801 module
You can manually select reagent cassettes for unloading, if
you, for example, want to free up space. You can manually
select reagent cassettes for unloading only in Standby
mode.
The reagent cassettes that you select manually for

unloading are shifted to the unloading position in the
reagent storage by the system. The system automatically
unloads all reagent cassettes, those which you manually
selected for unloading and those which the system itself
selected for unloading.
The instrument automatically selects reagent cassettes

for unloading under the following conditions:
• Reagent cassettes in which foam or air bubbles were
detected
• Reagent cassettes in which evaporation was detected
during the initial volume check
• Expiry masked reagent cassettes
In Operation mode, loading of reagent cassettes has

priority over unloading. During operation, empty reagent
cassettes are automatically shifted to the unloading
position if there is a standby reagent cassette for the test.
r To manually select reagent cassettes

for unloading
1
2 From the Module drop-down list, select the e 801

option.
5 Reagents
3
3 Choose the reagent cassette that you want to unload.
Roche Diagnostics
4
5
5 To select the reagent cassette for unloading, choose
the Select R. Pack option.
I If you choose the All R. Pack option, all reagent
cassettes are selected for unloading.
f In the Mark column of the Setting list, all
automatically or manually selected reagent
cassettes are marked with a – (minus).
f The next time you change reagent cassettes, the
system will automatically unload all marked reagent
cassettes.
u Related topics
• Changing more than 5 reagent cassettes on the e 801
• Changing up to 5 reagent cassettes on the e 801
• Changing reagent cassettes for later processing on the
• Changing reagent cassettes on the e 801 module for
Changing more than 5 reagent cassettes on the e 801 module in Standby

mode
To load more than 5 reagent cassettes successively in
Standby mode, you press the load button for less than
2 seconds.


5 Reagents
Roche Diagnostics
r To change more than 5 reagent

cassettes successively
1
1 To raise the reagent loader, press the load button.
2 Wait until the load button stops flashing.

I In case the operator starts unloading a reagent
cassette from the reagent loader during flashing,
the LED might be green or yellow.
Even if the LED is green or yellow, you can continue
changing the reagent cassette or finish the loading
or the unloading.
A B C 3
2
3 Unload any reagent cassettes from the reagent loader,
which the system has unloaded automatically:
• Check for alarm messages that explain a problem on
hand. The status indicator corresponding to the
reagent cassette lights yellow or is flashing yellow.
• If the status indicator lights yellow C and no alarm
has been issued, then the unloaded reagent
cassette is empty.
Dispose of the reagent cassette according to local
regulations.
• If the status indicator lights green A, you must have
manually selected the reagent cassette for
unloading before.
Close the caps of the reagent cassette fully and
A Status indicator C Status indicator store it according to the Instructions for Use for
lighting green lighting yellow later use. Alternatively, dispose of the reagent
B Status indicator cassette according to local regulations.
flashing yellow
5 Reagents
Roche Diagnostics
A B C D E 4
4 Fully insert the required reagent cassettes into the
reagent loader.
I If reagent cassettes are not fully inserted, an alarm
“reagent bottle shift” occurs. If this is the case,
push the reagent cassettes further into the reagent
loader.
f The cap pre-opener at the top of the loading ports
automatically sets the caps of the reagent
5 cassettes to the soft-close position.
5 If you want to keep the reagent loader raised for 2 more

minutes and all status indicators begin flashing yellow
simultaneously, press the reset button.
I If you do not press the reset button, the reagent
A Loading port 5 D Loading port 2 loader moves down automatically. Reagent
(lowest priority) cassettes on the reagent loader are not yet
B Loading port 4 E Loading port 1 registered. Press the load button to raise the
C Loading port 3 (highest priority) reagent loader, and press it again to register the
reagent cassettes.
6
6 Press the load button B for less than 2 seconds.
f The reagent loader moves down and pauses half
way for RFID tag reading.
f If the reagent cassettes can be registered, the
status indicator for each reagent cassette lights up
green. All reagent cassettes are transferred to the
reagent disk and processed later.
f If a status indicator does not light up green, the
corresponding reagent cassette cannot be
registered. Then, all reagent cassettes are
transported back up.
f In any case, the reagent loader moves up again.
A B
7 If the reagent loader has transported any reagent
A Status indicator lighting up green cassettes back up, do the following:
B Load button • Unload reagent cassettes from the reagent loader
immediately. The reagent loader will move down
after 2 minutes.
• If the status indicator lights yellow and no alarm has
been issued, then the unloaded reagent cassette is
5 Reagents
empty.
regulations.
8 To load more reagent cassettes, repeat steps 4 to 7 as

often as required.
Roche Diagnostics
9 To finish loading, press the load button for more than

2 seconds.
f If all reagent cassettes can be registered, the
reagent disk. The reagent loader stays lowered.
Those reagent cassettes loaded last and all
reagent cassettes successively loaded before are
processed now.
registered. Then, all reagent cassettes loaded last
are transported back up.
10 If the reagent loader has transported the reagent

cassettes back up, do the following:
reagent cassette lights red or is flashing red.
• If the status indicator lights red and no alarm has
empty.
regulations.
11
11 Wait for the reagent cassettes to be processed.
f After the reagent cassettes have been processed
and registered, the instrument changes from
Reagent Registration mode back to Standby mode.
f On the Reagent > Setting menu, the reagent
cassettes that were registered are displayed.
u Related topics
• Manually selecting reagent cassettes for unloading
from the e 801 module (412)
e 801 module (411)
Changing up to 5 reagent cassettes on the e 801 module in Standby mode

5 Reagents
To load up to 5 reagent cassettes and process them

immediately in Standby mode, you press the load button
for less than 2 seconds.

Roche Diagnostics
r To change up to 5 reagent cassettes

at once
1

or the unloading.
A B C 3
2
cassette is empty.
regulations.
unloading before.
flashing yellow
5 Reagents
Roche Diagnostics
A B C D E 4
reagent loader.
loader.

reagent cassettes.
6
6 To finish loading, press the load button B for more than
2 seconds.
reagent disk. The reagent loader stays lowered. All
reagent cassettes are processed now.
A B
A Status indicator lighting up green 7 If the reagent loader has transported the reagent
B Load button
• Unload inversely loaded reagent cassettes from the
reagent loader immediately. The reagent loader will
move down after 2 minutes. Inversely loaded
reagent cassettes might damage the instrument.
5 Reagents

empty.
regulations.
Roche Diagnostics
8
and registered, the instrument changes from
Reagent Registration mode back to Standby mode.
f On the Reagent > Setting menu, the reagent
cassettes that were registered are displayed.
u Related topics
e 801 module (411)
Changing reagent cassettes for later processing on the e 801 module in

Operation mode
To load reagent cassettes in Operation mode that you do
not require urgently, you press the load button for less
than 2 seconds.
The reagent cassettes are processed when at least

3 empty sampling cycles are available.


for later processing
1

or the unloading.
5 Reagents
Roche Diagnostics
A B C 3
2
cassette is empty.
regulations.
unloading before.
flashing yellow
A B C D E 4
reagent loader.
loader.

reagent cassettes.
5 Reagents
Roche Diagnostics
6
6 To finish loading, press the load button B for less than
2 seconds.
green. The reagent loader stays lowered. Those
reagent cassettes that can be registered stay in the
reagent loader until at least 3 empty sampling
cycles are available. When at least 3 empty
sampling cycles are available, these reagent
cassettes are transferred to the reagent disk and
processed.
A B
A Status indicator lighting up green corresponding reagent cassette cannot be
B Load button registered. Then, all reagent cassettes are
7 If the reagent loader has transported the reagent

empty.
regulations.
8
8 You can continue with any other task that is possible in
Operation mode.
f The reagent cassettes stay in the reagent loader
and wait to be processed.
f While processing and registering the reagent
cassettes, the instrument stays in Operation mode.
and registered, the reagent cassettes are displayed
on the Reagent > Setting menu.
5 Reagents
u Related topics
e 801 module (411)
Roche Diagnostics
Changing reagent cassettes on the e 801 module for immediate processing

in Operation mode
To load and immediately process reagent cassettes in
Operation mode, you press the load button for more than
2 seconds.
The current sampling cycle is interrupted and the reagent

cassettes are processed as soon as possible.


for immediate processing
1

or the unloading.
A B C 3
2
cassette is empty.
regulations.
5 Reagents

unloading before.
flashing yellow
Roche Diagnostics
A B C D E 4
reagent loader.
loader.

reagent cassettes.
6
6 To finish loading, press the load button B for more than
2 seconds.
green. The reagent loader stays lowered. These
reagent cassettes are transferred to the reagent
disk and processed as soon as possible.
A B
A Status indicator lighting up green 7 If the reagent loader has transported the reagent
B Load button
5 Reagents

empty.
regulations.
Roche Diagnostics
8
f While processing and registering the reagent
cassettes, the instrument stays in Operation mode.
and registered, the reagent cassettes are displayed
on the Reagent > Setting menu.
u Related topics
e 801 module (411)
5 Reagents
Roche Diagnostics

e 801 module
Measurement of certain analytes requires dissociation
from binding proteins. To prepare the sample for
measurement, some immunology tests use a pretreatment
procedure.
Pretreatment reagents are provided in separate reagent

cassettes. You must make sure that the instrument links a
given pretreatment reagent cassette to the corresponding
assay reagent cassette.
In this section
About pretreatment reagents and the PT link function on
e 801 module (426)
About pretreatment reagents and the PT link function on the e 801 module
A pretreatment and an assay reagent cassette form a pair.
The linkage is established during reagent loading following
a set of rules. Mainly, the link status of a reagent cassette
indicates the possibility to link the corresponding
pretreatment and assay reagent cassettes.
After registration, a pretreatment reagent cassette always

forms a pair with an assay reagent cassette of the same
test and the same lot. This function is called PT link. The
linkage is required for reasons of stability.
The instrument registers a pretreatment reagent cassette

automatically and links it to the assay reagent cassette
while both have the link status Free.
A B Both reagent cassettes, pretreatment and assay, can have

one of the following link statuses:
A Assay reagent B Pretreatment reagent

cassette cassette
5 Reagents
Roche Diagnostics
Link status Explanation

Free The pretreatment or assay reagent cassette is not yet linked to
another reagent cassette. Free reagent cassettes are not
available for measurement.
Linked The pretreatment or assay reagent cassette is available for

measurement.
Empty One or both of the linked reagent cassettes are empty.
Reagent cassettes that are not linked have become empty for
some reason.
y Explanation of the link statuses
For linking, the following rules apply:

• If the instrument recognizes an assay reagent cassette
with the link status Free, the instrument tries to find a
pretreatment reagent cassette available for linking.
• The linkage is stored at the registration time of the
assay reagent cassette and/or the pretreatment
reagent cassette.
• Once an assay reagent cassette and a pretreatment
reagent cassette are linked, neither can be linked to
another reagent cassette.
• The lower number of remaining tests in one of the linked
reagent cassettes determines the number of available
tests.
• When one of the 2 reagent cassettes is empty, both
reagent cassettes cannot be used anymore.
Linking pretreatment and assay reagent cassettes on the e 801 module

The instrument links pretreatment reagent cassettes and
assay reagent cassettes automatically while the reagent
cassettes have the link status Free. You only need to load
the corresponding reagent cassettes at the same time.
5 Reagents
j m The lot number of the pretreatment reagent cassette is

identical to the lot number of the assay reagent
cassette.
m Both reagent cassettes are new and thus, have the link
status Free.
Roche Diagnostics
r To link pretreatment and assay

reagent cassettes
1 Load the pretreatment reagent cassette.
2 Load the assay reagent cassette.

f The instrument recognizes that both reagent
cassettes have the link status Free. Then, the
instrument links both reagent cassettes.
3
3 On the Reagent > Setting menu, find both reagent
cassettes and remember their positions.
4
4 To display the Detail dialog box for these reagent
cassettes, choose Overview > and click on the
segments of the reagent disk with the positions you
remembered.
f The Type field shows if the selected reagent
cassette is a pretreatment reagent cassette or
f The PT-Link table shows the link status of the
selected reagent cassette and information about
the other linked reagent cassette.
u Related topics

e 801 module
5 Reagents
The instrument links reagent cassettes that are part of

linked kits automatically. You only need to load the
corresponding reagent cassettes at the same time.
The instrument supports linkage of up to 10 individual

reagent cassettes. If 1 of the individual reagent cassettes
is empty, all individual reagent cassettes of that linked kit
are marked empty.
Roche Diagnostics
j m The lot numbers of the reagent cassettes that are part

of the linked kit are identical.
m All reagent cassettes are new.
r To link reagent cassettes as part of

linked kits
1 Load the reagent cassettes that are part of the linked

kit.
f The instrument recognizes that the reagent
cassettes are part of a linked kit and new. Then, the
instrument links the reagent cassettes.
2
2 On the Reagent > Setting menu, find the reagent
cassettes of the linked kit and choose any one of the
reagent cassettes.
I In the Mark column, reagent cassettes that are part
of linked kits have an @ mark.
3
3 Choose the R. Pack Set Information button.
4
4 Verify that the status of the linked kit is Complete.
u Related topics
5 Reagents
Changing system reagents on the e 801 module

When a system reagent is empty, you change it to ensure
measurement.
Roche Diagnostics
A B Green illuminated push buttons indicate the following

status of the PreClean II M, ProCell II M, and CleanCell M
bottles:
OFF This bottle is in use.

Do not change it.
ON This bottle is in standby.

Do not change it.
Flashing This bottle is empty or air bubbles have been

detected.
It is safe to change it.
u Air bubbles in syringes (1269)
C D E
A Green buttons for D ProCell II M bottles
PreClean II M u Skin inflammation or injury
B Green buttons for E CleanCell M bottles u Infectious waste
ProCell II M and
CleanCell M u Expired reagents or mixing reagents
C PreClean II M bottles u Incorrect reagent volume

! WARNING
Incorrect results or delayed results may occur due
to errors when replacing system reagent bottles
If you press a green button without having changed the
corresponding bottle, the volume available for pipetting
may be less than expected by the instrument. This
difference can cause deterioration in measurement
accuracy. If the instrument detects reagent shortage, an
instrument alarm is issued.
r Only change a bottle if the green button is flashing, or if
the system reagent is expired or the onboard stability
has been exceeded.
r Always replace empty system reagents with new and
full bottles.
r After you have changed a system reagent bottle, press
the corresponding green button.
5 Reagents
Roche Diagnostics
! CAUTION
mechanism
in personal injury.
parts specified.
In this section
Changing ProCell II M and CleanCell M bottles on the e 801
module (430)
Changing PreClean II M bottles on the e 801 module (433)
Changing ProCell II M and CleanCell M bottles on the e 801 module

When a ProCell II M or CleanCell M bottle is empty, you
change it to ensure measurement.
When the onboard stability of a ProCell II M bottle is

exceeded, the system masks the ProCell II M bottle.
While you change the bottle, the e 801 module can

continue operating with the second bottle.
! WARNING
Touching the aspiration pipes or aspiration filters
may lead to contamination and instability of the
system reagents.
r Do not touch the aspiration pipes or aspiration filters.
r Use a cloth moistened with alcohol if you touched the
aspiration pipes or aspiration filters accidentally.
d m Lint-free cloth pads

m A new and full ProCell II M bottle or CleanCell M bottle
j m The green button above the bottle that you want to

5 Reagents
change is flashing.
Roche Diagnostics
r To change ProCell II M or CleanCell M

bottles
1
2
2 To secure the aspiration pipe B on the notch A, pull it
up and to the left.
A
B
A Notch B Aspiration pipe
5 Reagents
Roche Diagnostics
3
3 Absorb liquid from the filter A with lint-free cloth pads.
A
A Filter
4
4 Remove and dispose of the empty bottle according to
local regulations.
5
bottles.
5 Place the new bottle onto the correct bottle position.
6 Remove the cap.

5 Reagents
Roche Diagnostics
7
7 WARNING! Incorrect results may occur when the filter
at a ProCell/CleanCell aspiration pipe is loose or lost.
Check that the filter is fixed at the lower end of the
aspiration pipe. WARNING! Incorrect results due to
system reagent shortage in the PC/CC cups if the filter
is not submerged inside the bottle.
7 Unhook the aspiration pipe and carefully lower it into
the new bottle.
f The slider cap closes the bottle.
8 To prevent evaporation, make sure that the bottle is

closed properly by the slider cap.
9
9 Press the flashing green button corresponding to the
new bottle.
f The button stops flashing and stays on, indicating
that this bottle is a standby bottle.
f For ProCell II M bottles, the date and time of
registration and the status Used are written to the
RFID tag. Therefore, these ProCell II M bottles
cannot be used on another system.
q On the e 801 module, the RFID tag on the

ProCell II M bottle contains the lot number. Unlike with
the e 602 module, you do not need to enter a new lot
number manually.

foam in PreClean II M bottles.
Changing PreClean II M bottles on the e 801 module

When a PreClean II M bottle is empty, you change it to
ensure measurement.

continue operating with the second bottle of PreClean II M.

5 Reagents
m A new and full PreClean II M bottle

change is flashing.
Roche Diagnostics
r To change PreClean II M bottles
1
A 2 To secure the aspiration pipe B on the notch A, pull it

up and turn it slightly.
B
A Notch B Aspiration pipe
3
3 NOTICE Instrument damage when a PreClean aspiration
pipe is secured on the notch.
Do not close the front door until you have lowered the
aspiration pipes into the bottles again.
3 Absorb liquid from the filter with lint-free cloth pads.
5 Reagents
Roche Diagnostics
4
4 To remove the empty bottle, tilt the top of the bottle
forward and lift the bottle.
5 Dispose of the empty bottle according to local

regulations.
6
6 WARNING! Incorrect results due to foam. Handle the
new PreClean II M bottle gently to avoid the formation
of foam. WARNING! Incorrect results may occur due to
bottles.
6 Place the new PreClean II M bottle gently onto the
bottle stand.
7
at a PreClean II M aspiration pipe is loose or lost.
aspiration pipe.
the new bottle.

9
position of the new bottle.
5 Reagents

Roche Diagnostics
Replacing consumables and changing solid waste boxes

on the e 801 module
Consumables are AssayTips and AssayCups. AssayTips are
used for pipetting, and AssayCups are used for incubating.
AssayTips and AssayCups are provided to the instrument in
magazines. When AssayTips and AssayCups have been
consumed, you replace them and empty the waste.
The AssayTips and the magazines for the e 801 module

differ from those of the e 602 module while the AssayCups
are identical.
Used AssayTips and AssayCups are collected in the solid

waste boxes. Empty magazines are collected in the
magazine waste compartment.
A B C
You access the magazines and solid waste by opening the
magazine drawer. The status indicator of the magazine
drawer indicates whether you can open the magazine
drawer:
Off Operating
Do not open the magazine drawer.
Flashing About to operate

On The magazine drawer is safe to open.
The green buttons indicate the status of the solid waste

boxes:
A Status indicator of C Green buttons for solid Off The solid waste box is in use.
magazine drawer waste boxes Do not replace it.
B Handle of the
magazine drawer On The solid waste box is empty and in standby.
Do not replace it.
Flashing The solid waste box is full and safe to

replace.
Empty it immediately.

u Infectious waste
5 Reagents
u Excessive weight on magazine drawer
In this section
Replacing consumables on the e 801 module (437)
Changing solid waste boxes on the e 801 module (438)
Roche Diagnostics
Replacing consumables on the e 801 module

When AssayTips and AssayCups have been consumed, you
replace them and remove the empty magazines.
To check for consumables to replace, you can print a

d m AssayTip/AssayCup magazines
j m The green status indicator at the top of the magazine

drawer is on, not flashing.
r To replace consumables
1
1 Pull out the magazine drawer all the way.
2 Take out the empty magazines.
3 Dispose of the empty magazines according to local

regulations.
4 Close the magazine drawer and make sure that the

magazine drawer is fully closed.
5
transparent door.
7 Close the door and make sure that the door is fully
closed.
5 Reagents
u Related topics
• Changing solid waste boxes on the e 801 module (438)
Roche Diagnostics
Changing solid waste boxes on the e 801 module

When AssayTips and AssayCups have been consumed and
disposed of, you change the solid waste boxes.
A solid waste box is also called Wasteliner. If the green

button for one or both solid waste boxes is flashing, you
change the full solid waste boxes for new empty ones.
When to change the solid waste boxes is indicated on the

Reagent Overview dialog box or by an instrument alarm.
d m Wasteliner
j m The green button for the solid waste box that you want
to change is flashing.
m The green status indicator at the top of the magazine
r To change solid waste boxes
1
2 Change one or both solid waste boxes A as indicated by

the flashing green buttons B.
3 Dispose of the solid waste boxes according to local

regulations.

A B
A Two solid waste boxes B Two green buttons for
the solid waste boxes
5 Reagents
Roche Diagnostics
5
transparent door.
6
changed solid waste box.
that this solid waste box is in standby.
closed.
A B
A Position 1: Green B Position 2: Green

button for left solid button for right solid
waste box waste box
5 Reagents
Roche Diagnostics
440 Reagents and consumables on the e 602 module
Reagents and consumables on the e 602

module
The e 602 module requires specific reagents and
consumables to operate.
In this section
About e 602 module reagents and consumables (440)
module (444)
Changing reagent cassettes on the e 602 module (445)
e 602 module (448)
Changing system reagents on the e 602 module (452)
Replacing consumables and changing solid waste boxes on
About e 602 module reagents and consumables

Reagents of the e 602 module are either supplied in
Reagent cassettes for e 602 modules The cobas e pack for e 602 modules is the principal
reagent cassette.
The barcode label on the reagent cassette contains

information about the reagent, e.g.:
• Test name, e.g., TSH
• Lot number
• Expiry date
A reagent cassette for e 602 modules consists of one to

3 capped reagent bottles.
The following reagent types are provided in reagent

5 Reagents
A B C cassettes:
A Reagent 2 (R2) C Microbeads

B Reagent 1 (R1)
Roche Diagnostics
Reagents and consumables on the e 602 module 441
Reagent type Configuration of reagent cassette

Assay Three reagent bottles
Diluent One or 2 reagent bottles
Pretreatment (sample One or 2 reagent bottles
pretreatment used for
specific immunology
tests)
y Reagent types in reagent cassettes
Microbeads are necessary for every immunology test.

Microbeads are always supplied in assay reagent
cassettes.
Diluents Dilution of samples is necessary if the analyte

concentrations exceed the measuring range of the
respective immunology test method. In addition, general
predilution of samples is specified for some immunology
tests.
Examples of diluents are:

• Diluent Universal
• Diluent MultiAssay
u Instructions for Use of the respective application
Calibrators and QC material There are specific calibrators for each immunology test.
Some immunology tests use inpack calibrators. Inpack

calibrators are delivered within the reagent package.
For QC, there is QC material that covers multiple

immunology tests and QC material that is specific for only
a single immunology test.
Calibrators and QC material can sometimes be provided in

pre-barcoded vials. Often calibrators and QC material are
provided as a lyophilisate. You dissolve the lyophilisate and
transport it into a vial that you barcode yourself.
Barcodes can be single barcodes or dual barcodes for

different systems.
5 Reagents
For details, refer to the Instructions for Use of the

respective calibrator or QC material.
u Instructions for Use of the corresponding assay
reagent
Roche Diagnostics
Consumables
Single-use tips, called AssayTips, are used for sample

pipetting. Single-use reaction vessels, called AssayCups,
are used for incubating.
AssayTips and AssayCups are called consumables and

provided to the instrument in magazines. The magazines
are specific for the e 801 and the e 602 module,
respectively, and are not interchangeable.
Manual registration
A manual registration of reagent cassettes is not possible.
About e 602 module system reagents

The e 602 module requires e 602 system reagents for
supportive processes of the measurements.
The e 602 module uses the following system reagents:

• ProCell M solution
• CleanCell M solution
• PreClean M solution
• ProbeWash M solution
• ISE Cleaning Solution/Elecsys SysClean (not on the
instrument)
A B C
A Two PreClean M C Two CleanCell M

bottles bottles
B Two ProCell M bottles
5 Reagents
ProCell M solution The instrument requires ProCell M solution for the

following purposes:
• Transport of the assay reaction mixture
• Washing of the microbeads
• Signal generation
Roche Diagnostics
CleanCell M solution The instrument requires CleanCell M solution for cleaning

the tubing system and measuring cells and for conditioning
the electrodes.
PreClean M solution The instrument requires PreClean M solution to remove

potentially interfering substances before signal
generation.
Only certain immunology tests require this step. The

Instructions for Use of the respective assay reagent
indicate the use of PreClean M solution.
ProbeWash M solution To prevent carryover, the instrument requires

ProbeWash M solution for special washes of the reagent
probe.
The ProbeWash M bottles are located near the reagent

probe rinse station next to the reagent disk.
About 350 tests with carryover washes can be performed

from one ProbeWash M bottle. For finalization, about
200 µL of ProbeWash M solution are required.
A B
A Reagent probe rinse B Two ProbeWash

station bottles
ISE Cleaning Solution/Elecsys SysClean You use SysClean solution for cleaning the ECL flow path in
a maintenance action.
SysClean solution is not permanently on the instrument.

u Cleaning the ECL flow path of the e 602 module (1127) 5 Reagents
Roche Diagnostics
ProCell M CleanCell M PreClean M ProbeWash M

Number of tests per bottle ≥ 1000 ≥ 1000 ≥ 1200 approx. 350
Dead volume 20 mL 20 mL 3 mL
y Specifications of system reagents
! WARNING
system reagents
Results based on expired system reagents are not reliable.
r Do not use system reagents that have exceeded their
expiry date or onboard stability.

changing reagent cassettes on the e 602 module.
Barcode scans Each reagent cassette is labeled with 2 matrix barcodes.

The barcode reader scans only the barcode facing the
center of the reagent disk, the other barcode is used by
other analyzers. The instrument receives the
corresponding parameters from the data manager.
Priority of reagent cassettes If there are multiple reagent cassettes for one application
on an e 602 module, these reagents are used up in the
following order:
1. Current reagent cassette
2. Reagent cassette with the same lot number as the last
used reagent cassette
3. Reagent cassette of lot that expires first
4. Within the same lot: The reagent cassette with the
oldest registration date
5. Within the same lot: Reagent cassette with the least
remaining volume
6. Within the same lot: Reagent cassette in the lowest
position
5 Reagents
Generally speaking, the older reagent takes precedence

over the newer one.
Roche Diagnostics
Remaining volume control After a reagent cassette has been registered, the
instrument counts every pipetting out of this reagent
cassette. Thus, the reagent cassette’s initial number of
remaining tests is counted down. Irrespectively, a liquid
level detection is performed for accurate pipetting. The
instrument does not update the remaining volumes with
liquid level detection results.
If the total number of available tests for an application on

one module is lower than a defined limit, the instrument can
issue an alarm. Therefore, the yellow and purple warning
levels must be set for each application. When the number
of available tests is 0, a red alarm is issued. The test is
masked unless another reagent cassette is available as a
standby reagent or on a second module.
Changing reagent cassettes on the e 602 module

When the remaining volume of a reagent cassette is low, or
the expiry date has been exceeded, you change it to
ensure correct measurement.
You can remove and later reuse reagent cassettes.

Storage conditions of used reagent cassettes are
described in the Instructions for Use of the respective
immunology test.
The instrument monitors the remaining volumes by

counting down. After loading new reagent cassettes, the
instrument starts counting at the initial number of available
tests. After loading reagent cassettes that have already
been used before, the instrument continues counting at
the last monitored number of available tests.
If a reagent is empty, missing, or below a set volume level,

the Reagent Preparing button and the Reagent Overview
button change their color to red, yellow, or purple.

5 Reagents

Roche Diagnostics
! WARNING
reagent temperature
Taking reagent cassettes directly from the refrigerator
may cause incorrect results.
r Only insert reagent cassettes at the correct
temperature of 20 °C ± 3 °C (68 °F ± 5.4 °F).
q A used reagent cassette can be loaded onto another

module within the same system.

u Moving parts
r To change reagent cassettes
1
1 Lift off the reagent disk cover.
5 Reagents
Roche Diagnostics
2
2 Fully close the reagent cassettes (A) to be removed.
A B C
A Fully closed C Soft-closed

B Open
3
3 Remove the reagent cassettes from the reagent disk.

• If the reagent cassette is empty or expired, dispose
of it according to local regulations.
• If you want to reload the reagent cassette later,
close the caps fully and store it in the refrigerator
according to the Instructions for Use.
5 To load a reagent cassette, open the caps and ensure

that there is no foam inside the bottles of the reagent
cassette.
6
6 Put the caps of the reagent bottles to soft-close
position.
5 Reagents
Roche Diagnostics
7 Place the reagent cassette onto the reagent disk:

7
• Ensure the correct orientation of the reagent
cassettes with the white or clear bottles facing
outwards and the black bottles facing inwards.
• Place reagent cassettes with only one or 2 reagent
bottles at the inside of the reagent disk.
I The reagent disk has pins that snap into semicircular
openings in the reagent cassettes if the reagent
cassettes are correctly oriented.
If the pins do not snap in, the reagent cassettes are
not correctly oriented.
8 Close the cover of the reagent disk.

f A reagent scan is activated and the Reagent
Overview dialog box is updated.

e 602 module
Measurement of certain analytes requires dissociation
from binding proteins. To prepare the sample for
measurement, some immunology tests use a pretreatment
procedure.
Pretreatment reagents are provided in separate reagent

cassettes. You must make sure that the instrument links a
given pretreatment reagent cassette to the corresponding
In this section
About pretreatment reagents and the PT link function on
e 602 module (450)
5 Reagents
Roche Diagnostics
About pretreatment reagents and the PT link function on the e 602 module
Pretreatment and assay reagent cassettes form a pair. The
linkage is established during reagent loading following a
set of rules. Mainly, the link status of a reagent cassette
indicates the possibility to link the corresponding
pretreatment and assay reagent cassettes.
After registration, a pretreatment reagent cassette always

forms a pair with an assay reagent cassette of the same
test and the same lot. This function is called PT link. This
linkage is required for reasons of stability.
The instrument registers a pretreatment reagent cassette

automatically and links it to the assay reagent cassette
while both reagent cassettes have the link status Free.
A B
Both reagent cassettes, pretreatment and assay, can have
A Assay reagent B Pretreatment reagent
cassette cassette one of the following link statuses:
Link status Explanation

Free The pretreatment or assay reagent cassette is not yet linked
to another reagent cassette. Free reagent cassettes are not
available for measurement.
Linked The pretreatment or assay reagent cassette is available for

measurement.
Empty One or both of the linked reagent cassettes are empty.
Reagent cassettes that are not linked have become empty for
some reason.
y Explanation of the link statuses 5 Reagents
Roche Diagnostics
For linking, the following rules apply:

• If the instrument recognizes an assay reagent cassette
with the link status Free, the instrument tries to find a
pretreatment reagent cassette available for linking.
• The linkage is stored at the registration time of the
assay reagent cassette and/or the pretreatment
reagent cassette.
• Once an assay reagent cassette and a pretreatment
reagent cassette are linked, neither can be linked to
another reagent cassette.
• The lower number of remaining tests in one of the linked
reagent cassettes determines the number of available
tests.
• When one reagent cassette in the pair is empty, both
reagent cassettes cannot be used anymore.
Linking pretreatment and assay reagent cassettes on the e 602 module

The instrument links pretreatment reagent cassettes and
assay reagent cassettes automatically while reagent
cassettes have the link status Free. You only need to load
the corresponding reagent cassettes at the same time.
j m The lot number and ACN of the pretreatment reagent

cassette are identical to the lot number and ACN of the
m Both reagent cassettes are new and thus, have the link
status Free.
r To link pretreatment and assay

reagent cassettes
1 Load the new pretreatment reagent cassette and

remember the position on the reagent disk.
2 Load the new assay reagent cassette and remember

the position on the reagent disk.
f The instrument recognizes that both reagent
cassettes have the link status Free. Then the
5 Reagents
instrument links both reagent cassettes.
Roche Diagnostics
3
3 To display the Detail dialog box for a reagent cassette,
choose Overview > and click the segments of the
reagent disk with the positions you remembered.
f The Type row displays whether the selected reagent
cassette is a pretreatment reagent cassette or an
f The PT Link Status and subsequent rows display the
link status, sequence number and position of the
linked reagent cassette.
u Related topics
5 Reagents
Roche Diagnostics
Changing system reagents on the e 602 module

When a system reagent is empty, you change it to ensure
measurement.
A Green illuminated push buttons indicate the following

status of the PreClean M, ProCell M, and CleanCell M
bottles:
OFF This bottle is in use.

Do not change it.
ON This bottle is full and in standby.

Do not change it.
Flashing This bottle is empty, or air bubbles have

been detected.
It is safe to change it.
u Air bubbles in syringes (1269)
B C D
A Green buttons for C ProCell M bottles u Skin inflammation or injury
ProCell and CleanCell
u Infectious waste
B PreClean M bottles D CleanCell M bottles
! WARNING
Incorrect results or delayed results may occur due
to errors when replacing system reagent bottles
If you press a green button without having changed the
corresponding bottle, the volume available for pipetting
may be less than expected by the instrument. This
difference can cause deterioration in measurement
accuracy. If the instrument detects reagent shortage, an
r Only change a bottle if the green button is flashing, or if
the system reagent is expired or the onboard stability
has been exceeded.
r Always replace empty system reagents with new and
full bottles.
5 Reagents
r After you have changed a system reagent bottle, press

the corresponding green button.
Roche Diagnostics
! CAUTION
mechanism
in personal injury.
parts specified.
In this section
Changing ProCell M and CleanCell M bottles on the e 602
module (453)
Changing PreClean M bottles on the e 602 module (456)
Changing ProbeWash M bottles on the e 602 module (458)
Changing ProCell M and CleanCell M bottles on the e 602 module

When a ProCell M or CleanCell M bottle is empty, you
change it to ensure measurement.


change is flashing.
5 Reagents
Roche Diagnostics
r To change ProCell M or CleanCell M

bottles

2
2 To secure the aspiration pipe on the notch, pull it up
and to the left.
A B
A Aspiration pipe B Notch
3
3 Absorb liquid from the filter with lint-free cloth pads.
A
A Filter
4
local regulations.
5 Reagents
Roche Diagnostics
5
misplaced ProCell M/CleanCell M bottles.
5 Place the new bottle onto the correct bottle position.
6
6 Remove the cap.
7
aspiration pipe.
the new bottle.

9
new bottle.
5 Reagents

Roche Diagnostics
11
11 If you have loaded a ProCell M bottle with a new lot
number, enter this new lot number as follows:
• Mask the module and wait for the module to enter
Standby mode.
• In Reagent > Status, choose the Inventory Setting
button.
• In the Inventory Set dialog box, enter the new lot
number into the corresponding field for ProCell
Position 1 or 2.
• Choose the OK button.
u Related topics
• Masking a module for background maintenance (775)
Changing PreClean M bottles on the e 602 module

When a PreClean M bottle is empty, you change it to
ensure that measurement can be performed.
! CAUTION
Personal injury due to contact with PreClean probes
Touching the PreClean probes may lead to injuries.
r Do not put your fingers into the PreClean bottle stand.
r Only change a bottle if the green button is flashing.

You can change a PreClean M bottle in Operation mode.

But you can inform the instrument that a new bottle has
been loaded (by pressing the green button) only in Standby
mode.
5 Reagents

change is flashing.
Roche Diagnostics
r To change PreClean M bottles

2
local regulations.
3
3 WARNING! Incorrect results may occur due to errors
when changing PreClean bottles.
If you do not properly load the PreClean bottles or load
them without checking, the volume available for
pipetting may be less than expected by the instrument.
3 Place a full PreClean M bottle gently onto the bottle
stand to avoid the formation of foam. Make sure that
the new bottle is firmly in place, and that the probe has
pierced the bottle.
4
4 To allow air into the PreClean M bottle, loosen the cap.
5 Reagents
Roche Diagnostics
5
5 When the module is in Standby mode, press the flashing
green button corresponding to the position of the new
bottle.

Changing ProbeWash M bottles on the e 602 module

When a ProbeWash M bottle is empty, you change it to
ensure that measurement can be performed.
You can simply change the 2 ProbeWash M bottles when

necessary. The reagent probe is equipped with a liquid
level sensor. The liquid level sensor detects the remaining
volume.
r To change ProbeWash M bottles
1
1 Remove and dispose of the empty ProbeWash M bottle
2 Take off the cap of the new ProbeWash M bottle.
3 Place the new ProbeWash M bottle into the module.

f The level is checked, and the inventory is
5 Reagents
A B
A Reagent probe rinse B Two ProbeWash

station bottles
Roche Diagnostics
Replacing consumables and changing solid waste boxes

on the e 602 module
Consumables are AssayTips and AssayCups. AssayTips are
used for pipetting, and AssayCups are used for incubating.
AssayTips and AssayCups are provided to the instrument in
magazines. When AssayTips and AssayCups have been
consumed, you replace them and empty the waste.
The AssayTips and the magazines for the e 602 module

differ from those of the e 801 module while the AssayCups
are identical.
Used AssayTips and AssayCups are collected in the solid

waste boxes. Empty magazines are collected in the
magazine waste compartment.
A B C You access the magazines and solid waste by opening the

magazine drawer. The status indicator of the magazine
drawer indicates whether you can open the magazine
drawer:
Off Operating
Flashing About to operate

On The magazine drawer is safe to open.
The green buttons indicate the status of the solid waste

boxes:
A Status indicator of C Green buttons for solid Off The solid waste box is in use.
magazine drawer waste boxes Do not replace it.
B Handle of the
magazine drawer On The solid waste box is empty and in standby.
Do not replace it.
Flashing The solid waste box is full and safe to

replace.
Empty it immediately.

u Infectious waste
5 Reagents
u Excessive weight on magazine drawer
In this section
Replacing consumables on the e 602 module (460)
Changing solid waste boxes on the e 602 module (461)
Roche Diagnostics
Replacing consumables on the e 602 module

When AssayTips and AssayCups have been consumed, you
replace them and remove the empty magazines.
To check for consumables to replace, you can print a

d m AssayTip/AssayCup magazines
j m The green status indicator at the top of the magazine

r To replace consumables
1
2 Take out the empty magazines.

1
regulations.
2
5
transparent door.
closed.
5
5 Reagents
u Related topics
• Changing solid waste boxes on the e 602 module (461)
Roche Diagnostics
Changing solid waste boxes on the e 602 module

When AssayTips and AssayCups have been consumed and
disposed of, you change the solid waste boxes.
A solid waste box is also called Wasteliner. If the green

button for one or both solid waste boxes is flashing, you
change the full solid waste boxes for new empty ones.
When to change the solid waste boxes is indicated on the

Reagent Overview dialog box or by an instrument alarm.
d m Wasteliner
j m The green button for the solid waste box that you want
to empty is flashing.
m The green status indicator at the top of the magazine
r To change solid waste boxes
1
2 Change one or both solid waste boxes A as indicated by

the flashing green buttons B.
3 Dispose of the solid waste boxes according to local

regulations.

A B
A Two solid waste boxes B Two green buttons for

the two solid waste
boxes
5 Reagents
Roche Diagnostics
5
transparent door.
6
changed solid waste box.
that this solid waste box is in standby.
closed.
A B
A Position 1: Green B Position 2: Green

button for left solid button for right solid
waste box waste box
5 Reagents
Roche Diagnostics
463
Table of contents
Calibration 6
In this chapter 6
Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465
About calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465
About lot and cassette calibration . . . . . . . . . . . . . 467
About calibration methods . . . . . . . . . . . . . . . . . . . . 468
About calibration methods for photometric
tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 469
About calibration methods for ISE tests. . . . . . 470
About calibration methods for immunology
tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 471
About recommended calibration. . . . . . . . . . . . . . . 472
About manual calibration . . . . . . . . . . . . . . . . . . . . . 474
Performing recommended calibration . . . . . . . . . . 474
Performing manual calibration. . . . . . . . . . . . . . . . . 477
Creating a start-up group . . . . . . . . . . . . . . . . . . . . . 480
Checking and viewing calibration results . . . . . . . . 481
Checking calibration . . . . . . . . . . . . . . . . . . . . . . 481
Viewing calibration results . . . . . . . . . . . . . . . . . 482
Viewing calibration curves of photometric
tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483
Viewing photometric calibrator values . . . . . . . 484
Viewing recent calibrations . . . . . . . . . . . . . . . . 485
Handling calibrator data . . . . . . . . . . . . . . . . . . . . . . 486
Checking calibrator data . . . . . . . . . . . . . . . . . . 486
Installing calibrator data from the data
manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 488
Installing calibrator data manually . . . . . . . . . . 490
Editing calibrator concentration values on
cobas c modules . . . . . . . . . . . . . . . . . . . . . . . . . 491
Deleting calibrator data . . . . . . . . . . . . . . . . . . . 493
Assigning non-barcoded calibrators to rack
positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 494
Setting calibration auto-masking. . . . . . . . . . . . . . . 495
6 Calibration
Calibrating tests on the ISE and cobas c modules . . . 498

About loading photometric and ISE calibrators . . 498
About calibration of photometric tests. . . . . . . . . . 499
Loading calibrators for photometric and ISE tests 499
Calibrating tests on the cobas e modules . . . . . . . . . . 502
About calibration of immunology tests. . . . . . . . . . 502
About calibration of tests on the e 801 module 504
About calibration of tests on the e 602 module 505
Roche Diagnostics
464
Table of contents
About loading calibrators for immunology tests . . 506

Loading calibrators for immunology tests . . . . . . . 508
6 Calibration
Roche Diagnostics
Calibration 465
Calibration
In this section
About calibration (465)
About lot and cassette calibration (467)
About calibration methods (468)
About recommended calibration (472)
About manual calibration (474)
Performing recommended calibration (474)
Performing manual calibration (477)
Creating a start-up group (480)
Checking and viewing calibration results (481)
Handling calibrator data (486)
Assigning non-barcoded calibrators to rack positions (494)
Setting calibration auto-masking (495)
About calibration
The purpose of calibration is to assure accurate measuring
for all tests. Each test is calibrated to determine a valid
calibration factor. The measured values depend on the
measuring system and the reagents, and they may deviate
over time. Therefore it is necessary to repeat calibrations
regularly. However, the system provides a high calibration
stability to obtain long calibration intervals.
The instrument automatically recommends tests that must

be calibrated. You must perform this recommended
Calibration calibration before starting operation to avoid interruption
of operation. Additionally, you can choose individual tests
for manual calibration.
Calibration is specific for each module, reagent disk, and

Recommended Manual
measuring channel. Each module, reagent disk, and
measuring channel must be calibrated separately.
Recommended calibration If a test requires calibration, the instrument automatically

recommends calibrating this test. Before starting
operation, you must request all recommended tests for
6 Calibration
calibration. Depending on the specified calibration interval,

you may also need to calibrate tests that are
recommended during operation.
Manual calibration A request for calibration that is not recommended by the

instrument, is a manual calibration.
If you decide to perform a manual calibration, you must
individually select the tests to be calibrated and the
calibration method.
Roche Diagnostics
466 Calibration
Start-up calibration If you have to request a set of tests for manual calibration
regularly, you can create a start-up group. In this start-up
group, you define the tests and the calibration methods. By
choosing this start-up group, all defined tests are
requested for calibration.
Additionally, you must request tests that are
recommended for calibration.
QC after calibration If QC is activated and the QC racks follow the calibrator

racks directly, QC measurements are performed for all
tests that are newly calibrated. You do not have to request
this QC.
Calibration results When the set calibration quality criteria are met, the
calibration is considered successful. Otherwise, the
calibration has failed.
The instrument checks each calibration automatically. If

the calibration has been successful, the calibrated tests
are valid and the instrument continues operation. If the
instrument detects an irregular condition or result, an
alarm is issued, and the calibration is classified as failed
and recommended to be repeated.
You can check the results on the monitor, on the printed

output, or within TraceDoc on the data manager.
Calibration masking If no valid calibration is available for a test, calibration

masking ensures that this test is not measured.
The test can be masked separately for each particular
module.
If calibration masking is not activated, this test is measured
and a data alarm is attached to the results.
u Related topics
• Checking calibration (481)
• About calibration of tests on the e 801 module (504)
• Calib. and QC Settings window (1727)
6 Calibration
Roche Diagnostics
Calibration 467
About lot and cassette calibration

Each reagent cassette used for measuring must have a
valid calibration. The calibration data can be valid for a
particular reagent cassette (cassette calibration) or for an
entire lot (lot calibration).
New reagent cassette
No Yes
Lot calibration? Lot calibration Newest calibration
No Yes
Reagent cassette
< 24 h on board?
Calibrate Calibrate
No Yes
Calibration ok? Lot calibration Newest calibration
No Yes
Calibration ok? Cassette calibration Newest calibration
When you use a new reagent cassette, the instrument

checks the calibration status. If a valid lot calibration
exists, the reagent cassette is ready for photometric
measuring. If not, the reagent cassette must be calibrated.
Depending on how long the reagent cassette has been
loaded to the instrument, the calibration data can become
6 Calibration
the valid calibration data for the entire lot or for the
reagent cassette only.
Lot calibration If you calibrate a reagent cassette that has been loaded on
the instrument for less than 24 hours, the calibration is
valid for this reagent cassette and all reagent cassettes
belonging to the same reagent lot which are loaded after
this calibration.
Roche Diagnostics
468 Calibration
Cassette calibration The cassette calibration provides reagent disk and

measuring channel-specific calibration data for reagent
cassettes. If you calibrate a reagent cassette that has
been loaded to the instrument for more than 24 hours, the
calibration is valid only for the particular reagent cassette.
Expired reagent cassettes can only generate a cassette

calibration, no lot calibration. Exception: If the Reagent
Expired Mask check box is selected, the e 801 module
cannot use expired reagents for the measurement.
Newest calibration (cobas c modules only) When you load a new reagent cassette of a new lot on the
instrument, no applicable calibration data exists. In this
case, the data of the last valid lot calibration of the test
(newest calibration) is transferred to the reagent cassette
during registration.
u Related topics
• About calibration (465)
About calibration methods

Depending on the test and on the module, there are
different calibration methods.
In this section
About calibration methods for photometric tests (469)
About calibration methods for ISE tests (470)
About calibration methods for immunology tests (471)
6 Calibration
Roche Diagnostics
Calibration 469
About calibration methods for photometric tests

Photometric tests can be calibrated with up to 4 different
calibration methods, differing in the calibration curve and
the number of calibrators used: blank, 2-point, full, and
span calibration.
For recommended calibration, the instrument determines

the calibration method automatically. When calibrating
tests manually, you must select a calibration method.
Blank
The calibrator of the lowest analyte concentration is used

for calibration:
• Calibrator 1, for example, H2O.
Absorbance
The calibration curve is adapted without changing the

K-factor.
Concentration
2-point
2 calibrators are used for this calibration:

• Calibrator 1, for example, H2O, and a second
calibrator, for example, C.f.a.s.
Absorbance
The calibration curve is adapted by recalculating the

K-factor.
Concentration
Full
All calibrators are used for this nonlinear calibration:

• All calibrators defined for this test.
6 Calibration
Absorbance
The calibration curve is adapted by recalculating all

K-factors.
Concentration
Roche Diagnostics
470 Calibration
Span
1 calibrator is used for this calibration:

• One calibrator out of Calibrator 2 to 6.
Absorbance
The calibration curve is adapted by recalculating the

K-factor.
q This calibration method can only be applied to defined

tests.
Concentration
u Refer to the Instructions for Use for information about the
recommended calibration method for the test.
u For more information about the calibration curve types

and the K-factor, refer to Calibration principles in the
Online Help.
u Related topics
• About calibration curve types (1957)
• About the K-factor (1969)
About calibration methods for ISE tests
In the ISE unit, Na+, K+, and Cl- must be calibrated with the
full calibration method every 24 hours. Additionally, ISE
Internal Standard (IS) is measured during calibration, as
well as before and after each routine sample.
For each calibration, the calibrator solutions are aspirated

into the electrode and the electromotive force is
measured.
When starting the operation 24 hours after the last ISE

calibration, the full ISE calibration is automatically
recommended, if the Timeout setting under Utility
> Application is set accordingly.
When starting operation within 24 hours after the last ISE

6 Calibration
calibration, we recommend to manually request ISE

calibration. That way, you do not have to interrupt
operation.
Roche Diagnostics
Calibration 471
Full
All ISE calibrators are used for a full calibration:

• Calibrator 1: ISE Standard Low
• Calibrator 2: ISE Standard High (S2)
EMF [mV]
• Calibrator 3: ISE Standard High (S3) used as

compensator
The calibration curve is adapted by recalculating all

K-factors.
log Concentration
u For more information about ISE calibration, refer to
Calibration principles in the Online Help.
u Related topics
• About calibration methods of ISE tests (1952)
About calibration methods for immunology tests

A lot-specific master calibration curve is generated at
Roche Diagnostics during production of the reagent. You
must adapt these master calibration data to routine
laboratory conditions on site.
The master calibration curve is generated using lot-

specific test kit reagents and 5 or 6 master calibrators. The
instrument downloads the lot-specific calibration data
automatically from the data manager during reagent
registration.
To adapt the calibration data, you have to perform a

calibration on site. The calibration method to be used is
defined during the test development. You cannot choose
the calibration method.
The lot-specific master calibration uses a calibration factor

of 1. For all subsequent cassette calibrations, a new
calibration factor (also called factor) is calculated
according to the current lot calibration.
6 Calibration
Roche Diagnostics
472 Calibration
Full
On the e 602 module 2 calibrators are used to adjust the

master calibration curve (signal correction).
On the e 801 module 2, 4, or 5 calibrators can be used.

Response
Only for cassette calibration, the calibration curve is

adapted by recalculating the factor.
u For more information about the calibration methods,
Concentration refer to Calibration principles in the Online Help.
u Related topics
• Calibration of immunology tests (1979)
About recommended calibration

The instrument automatically recommends all tests that
require calibration. The tests recommended by the
instrument must be calibrated to ensure that the analytical
unit measures accurately. This recommended calibration is
performed before operation starts, and whenever tests
require calibration during operation.
If the Calib. and QC Select button turns yellow, calibration

of one or more tests is recommended. You must request
these tests for calibration before starting operation or as
soon as it fits into your operation workflow. Calibration is
performed for these tests with a preset calibration
method. Calibration and QC must be completed
successfully before operation.
In Calibration > Status, the reason of calibration is

displayed in the Cause column.
The instrument recommends calibration in the following

cases:
• Failed
6 Calibration
• Changeover
• Timeout
• QC Violation (recommended by the data manager)
• Calib Now
Roche Diagnostics
Calibration 473
Failed Recalibration must be performed when the calibration has

failed one or more calibration quality criteria.
u Overview of calibration quality criteria for ISE
tests (1954)
Overview of calibration quality criteria for photometric
tests (1976)
Overview of calibration quality criteria for immunology
tests (1981)
Changeover Calibration must be performed when you load a reagent

cassette without valid calibration:
• You load a reagent cassette of a new installed test.
• You load a reagent cassette with a new lot number.
• The Changeover Reagent Pack check box is selected
and you load a reagent cassette for this test
- For cobas c modules:
Utility > Application > Chemistry > Calib.
- For cobas e modules:
Utility > Application > Immune > Calib.
Calibration must also be performed when existing

calibration data cannot be transferred, as in the following
cases:
• You load a reagent cassette to another module.
• For c 701 and c 702 modules: You load a reagent
cassette to another reagent disk.
• You remove a reagent cassette which has been
registered but not calibrated. When you reload this
reagent cassette after a lot calibration, the lot
calibration data is not transferred (no back transfer of
calibration data).
Timeout Calibration must be performed at regular intervals to

compensate for changes in the reagents and/or in the
measuring system due to the course of time.
QC Violation Calibration must be performed when the QC results are

outside the limits.
Calib Now
6 Calibration
If a calibration is due within the time set in Calibration

> Status in the Remaining Time field, you can perform
calibration in advance. This ensures, that you do not have
to interrupt the operation for calibrating due tests.
Roche Diagnostics
474 Calibration
In the Overview menu, the Preventive Action check box

must be selected.
u Related topics
• Performing recommended calibration (474)
• Status submenu (1581)
About manual calibration

You can request a manual calibration by choosing
individual tests to be calibrated. These individual selected
tests can be based on laboratory regulations or objective
decisions. For example, your laboratory regulations may
require to calibrate every reagent cassette after loading,
even if it has a valid calibration.
Although a recommended calibration has been performed,

you can additionally perform manual calibration of any
test. To perform a manual calibration, you have to interrupt
the routine operation of the instrument.
For each manually requested calibration, you must

determine the calibration method.
You can define a start-up group for tests that regularly

must be calibrated manually.
In Calibration > Status, Manual is displayed in the Cause

column. The selected calibration method is displayed in the
Method column.
u Related topics
• About calibration methods for photometric tests (469)
Performing recommended calibration

6 Calibration
The instrument automatically recommends all tests that

must be calibrated. To ensure the accuracy of the
measured results, you must request all recommended
tests.
If a start-up group is defined for this working shift, you must

additionally calibrate this preset group of tests.
Roche Diagnostics
Calibration 475
The yellow Calib. and QC Select button indicates that

calibration and/or QC are recommended.

c • Before starting operation

• If necessary, during operation: when a reagent
cassette with no valid calibration is requested, at set
time intervals, or when a calibration has failed.
d m Calibrators
r To perform recommended calibration
1
1 Choose the Calib. and QC Select button.
2
2 To request recommended calibration, choose the
Recommended button in the Calibration group field.
f The required calibration tests are now requested.
f If the calibrators are loaded, the requested
calibration tests will be performed at the beginning
of the next run.
3 If you request recommended calibration at the

beginning of your work shift, also perform one of the
following steps:
6 Calibration
• If a start-up group is defined for this work shift, you

must manually request this start-up group for
calibration.
• If your work shift starts within less than 24 hours
since the last work shift, you must manually request
the ISE calibration.
4 To print the calibration load list, choose the Load List

Print button in the Calibration group field.
Roche Diagnostics
476 Calibration
6
7
7 Load the calibrator rack onto a rack tray.
8
8 At the rack input buffer, check that the green status
indicators are on.
9 Place the rack tray into the input buffer.
10 To start the measurement, choose the Start button.
12
12 In the Cause column, check the calibration results:
6 Calibration

regulations.
• If the calibration has failed, check the data alarms
and troubleshoot. Repeat the calibration for these
tests.
Roche Diagnostics
Calibration 477
u Related topics
• Measuring calibrators and QC material (295)
positions (494)
• Loading calibrators for immunology tests (508)
Performing manual calibration

Independent of the calibration recommended
automatically by the instrument, you can request manual
calibration for individual tests. For manually calibrated
tests, you have to select the calibration methods.
A full calibration of all ISE tests is required every 24 hours.
You can configure the calibration interval in Utility

> Application. When starting operation within 24 hours
after the last ISE calibration, you must manually request
ISE calibration. That way, you do not have to interrupt
operation.

c • Photometric tests: individual time interval

• ISE tests: when restarting operation within 24 hours
6 Calibration
d m Calibrators
Roche Diagnostics
478 Calibration
r To perform manual calibration
2
2 From the Test column, select the test to be calibrated.
3 From the drop-down list in the Method column, choose

the test-specific calibration method.
I For immunology test calibration and ISE calibration,
you must choose the Full option.
f The selected calibration method is displayed in the
Method column.
f In the Cause column, Manual is displayed and
highlighted blue.
f The Save button turns yellow.
4
4 If you have to cancel a calibration request, go on as
follows:
• Select the requested test to be canceled.
• From the drop-down list in the Method column,
choose the None option.
f In the Method column, None is displayed.
f In the Cause column, Manual disappears.

f All tests with a blue highlighted entry in the Cause
column are requested for calibration.
6 Print the calibration load list.
7
6 Calibration
Roche Diagnostics
Calibration 479
8
9
9 At the rack input buffer, check that the green status
indicators are on.
13
13 In the Cause column, check the calibration results:
regulations.
tests.
u Related topics
6 Calibration

positions (494)
Roche Diagnostics
480 Calibration
Creating a start-up group

You can select tests for manual calibration and define
them in a start-up group. This group of tests is requested
for calibration when choosing Overview > Calib. and QC
Select > .
r To create a start-up group
1
1 In Calibration > Status, choose the Start Up Setting
button.
2
2 Choose a test.
3 In the Method column, choose the appropriate

calibration method.
• For e 602 and e 801 modules, choose the Full
option.
• For ISE calibration, choose the Full option.
f The selected calibration method is displayed with
the test and the OK button turns yellow.
4 Repeat the steps 2 to 3 for the tests you want to define

in the start-up group.
u Related topics
• About calibration (465)
6 Calibration
Roche Diagnostics
Calibration 481
Checking and viewing calibration results

After calibration has been performed, you must check if
the calibration has been successful. You can also view
detailed information on the current calibration data, on the
measured values, and on the latest calibrations.
The current calibration data is monitored together with the

recent measurement data. With the Monitor button, you
can view the current calibration data.
The current calibration data is automatically available on

Print > History. On the calibration monitor report, you can
view the calibration results and check for calibration
alarms.
In this section
Checking calibration (481)
Viewing calibration results (482)
Viewing calibration curves of photometric tests (483)
Viewing photometric calibrator values (484)
Viewing recent calibrations (485)
Checking calibration
After calibration has been performed, you must check if
the calibration has been successful.
The instrument only uses tests with a valid calibration.
If the calibration of a reagent cassette fails, calibration is

automatically rejected by the software. Before
recalibrating, you must troubleshoot.
r To check calibration
2
2 In the Cause column, check if the calibration has been
6 Calibration
performed successfully:
• If the column is blank, the calibration has been
successful.
• If Failed is displayed in the column, the calibration
result of the corresponding test is not valid. This
test is recommended for calibration again.
Roche Diagnostics
482 Calibration
3 If the calibration has failed, do the following:

• View the calibration results.
• Check the alarms.
• Troubleshoot.
• Repeat the calibration for this test.
u Related topics
Viewing calibration results

Calibration results are displayed in the Print > History
window as soon as they are available. If you want to check
calibration results at a later stage or for specific modules,
use the following procedure.
r To view calibration results
1
2 If you want to display tests of a specific module, choose

a module in the Module drop-down list.
3 Choose the test.
4
4 Choose the Calibration Result button.
5
5 View the current calibration data on the selected test.
f The Calibration Result dialog box and the displayed
calibration data differ depending on the module
type on which the test is performed.
6 Calibration
6 Choose the Cancel button.
u Related topics
• Calibration Result (ISE) window (1593)
• Calibration Result (Photometry) window (1595)
• Calibration Result (Immune) window (1599)
Roche Diagnostics
Calibration 483
Viewing calibration curves of photometric tests

After calibration has been performed, you can view the
calibration curves of the calibration of photometric tests.
r To view calibration curves of

photometric tests
1

the module in the Module drop-down list.
3 Choose a photometric test.
4
4 Choose the Calibration Result button.
5
5 Choose a test.
6 Choose the Working Information button.
7
7 View the calibration curve of the selected test.
f The measured absorbance values (Y axis) can be
referred to concentration values (X axis).
6 Calibration
u Related topics
• Working Information window (1604)
Roche Diagnostics
484 Calibration
Viewing photometric calibrator values

After calibration has been performed, you can view
detailed information on the current photometric calibrator
absorbance values.
r To view photometric calibrator

values
1
2 To display tests of a specific module, choose the

module in the Module drop-down list.
3 Choose the photometric test.
4
4 Choose the Reaction Monitor button.
5
5 From the drop-down list above the chart, choose the
calibrator.
I The extensions 1st and 2nd refer to the first and
second measurement with the calibrator.
f In the chart, the latest measured absorbance values
of the selected calibrator are displayed.
6
6 To view the absorbance value measured at a specific
time, select the corresponding measuring point in the
6 Calibration
chart.
f The measured absorbance value is displayed in the
table below the chart.
u Related topics
• Reaction Monitor window (1608)
Roche Diagnostics
Calibration 485
Viewing recent calibrations

After calibration has been performed, you can view
detailed information on the most recent calibrations of
photometric, ISE, and immunology tests.
r To view the most recent calibrations
1

a module in the Module drop-down list.
3 Choose a test.
4
4 Choose the Calibration Trace button.
f The values of the 50 most recent calibrations for
the selected test are displayed.
5
5 If you want to view the most recent calibrations of
another test, choose the test in the Test/Module drop-
down list.
6
6 To view detailed information on a specific test
calibration, select the corresponding measuring point
in the chart.
6 Calibration
f The calibration data for the selected test is

displayed in the table below the chart.
u Related topics
• Calibration Trace window (1586)
Roche Diagnostics
486 Calibration
Handling calibrator data

Each Roche calibrator is specified by its calibrator data. A
file containing the calibrator data (calibrator code, lot
number, expiry date, and concentration value) can be
downloaded to the instrument from the data manager. The
data manager receives the calibrator file via an automatic
update function from cobas® link.
On cobas c modules, up to 160 calibrators can be

installed.
On cobas e modules, up to 100 calibrators can be

installed.
In this section
Checking calibrator data (486)
Installing calibrator data manually (490)
Editing calibrator concentration values on cobas c
modules (491)
Deleting calibrator data (493)
Checking calibrator data

You must check the registered calibrator data before
updating calibrator data.
r To check registered calibrator data
1
1 Choose Calibration > Install.
2 From the drop-down list above the list, choose one of

the options:
• To display photometric and ISE calibrators, choose
the Chemistry option.
• To display calibrators for immunology tests, choose
the Immune(e602) option or the Immune(e801)
option.
6 Calibration
Roche Diagnostics
Calibration 487
3
3 In the left list, choose a calibrator.
f The right list displays the corresponding calibrator
concentration values.
4 To view more information on the calibrator, choose the

Detail button.
5
5 To ensure that the latest released version is installed,
check the following calibrator data:
• Version
• Release Date
6
6 To view the assigned rack position, calibrator code, lot
number, or expiry date, choose Calibration
> Calibrators.
6 Calibration
Roche Diagnostics
488 Calibration
Installing calibrator data from the data manager

If you use a new calibrator, you must install the new
calibrator data. If the calibrator data, the calibrator
concentration value, or the decimal places of a calibrator
concentration value have changed, you install calibrator
data for an update.
You can download the current calibrator data to the

system from the data manager or install the calibrator data
manually. The data manager receives the data via an
automatic update function from cobas® link.
q You do not need to delete an installed calibrator

before you download a new calibrator lot or new version
number of the same calibrator lot.
However, if the measurement unit changes with the
download, you must delete the corresponding application
before updating. That way you ensure that the new data is
installed properly.

m You need supervisor or administrator access rights.
Administrators can download the calibrator data of a
new calibrator, of a new calibrator lot, or the newest
version of an installed calibrator lot.
Supervisors can download the calibrator data for the
newest version of a calibrator lot or for a different
calibrator lot with the same code.
r To download calibrator data
1
6 Calibration
2
2 If the measurement unit changes, delete the existing
calibrator data.
• In the left list, choose the calibrator to be deleted.
• Choose the Delete button and confirm the following
message.
Roche Diagnostics
Calibration 489
3
3 Choose the Download button.
4
4 Search for the calibrator to be downloaded:
• In the Search Using: check box, choose the Lot ID
option.
• In the Lot ID field, enter the calibrator lot number.
• Choose the Search button.
f The search results are displayed in the Result group
box.
5 In the Selection column, select the check box of the

calibrator you want to download.

f The Confirmation dialog box displays the calibrator
data for all modules using this calibrator.
7
7 Check and complete the following settings:
• Current Release Date field: Refers to the calibrator
lot currently on board. This is only available if you
request the same calibrator lot for download.
• Addition Release Date option: Shows the date of the
release that will be newly installed.
• Update Release Date option: Only displayed if you
update an existing calibrator.
I If you want to skip downloading calibrator data for a
specific module, choose the None option.
8 To start the download of the calibrator data, choose

the OK button and follow the instructions on the
screen.
f Existing calibrator data is overwritten.
10
10 In Calibration > Install, check if the calibrator data has
been downloaded correctly.
6 Calibration
11 If you work with non-barcoded calibrators, assign a rack

ID and rack position.
12 After downloading calibrator data, calibrate the

affected tests with the highest applicable calibration
method.
Roche Diagnostics
490 Calibration
u Related topics
• Deleting calibrator data (493)
positions (494)
• Install submenu (1621)
Installing calibrator data manually

If the calibrator data cannot be downloaded from the data
manager, you can manually add photometric or ISE
calibrators. Calibrators for immunology tests cannot be
installed manually.
After installing new calibrator data, you must attach the

barcode label to the calibrator or assign the calibrator to a
fixed rack position.
j m You need supervisor or administrator access rights.
r To install calibrators manually
1
2 From the drop-down list, choose the Chemistry option.
3
6 Calibration
Roche Diagnostics
Calibration 491
4
4 Fill in the necessary fields.
• The code must have a value from 1 through 998.
• In the Exp.Date: field, fill in first the year, then the
month of expiry.
5 Choose the OK button and confirm the caution

messages.
f The new calibrator appears on the left list.
6 Enter the calibrator concentration values.
u Related topics
• Checking calibrator data (486)
• Editing calibrator concentration values on cobas c
modules (491)
Editing calibrator concentration values on cobas c modules

On cobas c modules, you can manually change the current
concentration value of a calibrator. If you add calibrator
data manually, you must also enter the set calibrator
concentration values manually before calibrating.
You find the set calibrator concentration values in the

Instructions for Use.
When you download the same version of an e-barcode,

manually entered values are overwritten.
r To enter concentration values of a

calibrator on cobas c modules
1
2 From the drop-down list, choose the Chemistry option.

6 Calibration
3 In the left list, choose a calibrator.
Roche Diagnostics
492 Calibration
4
4 Choose the Edit button.
5
5 Choose the test.
6 In the Std Concentration group box, fill in the

concentration values into the corresponding fields.
• For cobas c modules, use the Std(1) field.
I Observe the measurement unit displayed below the
Std Concentration group box.
7 To complete the input, choose the Update button.
8 To enter concentration values for additional tests,

repeat steps 5 to 7.
9 To save all entries, choose the OK button.
10 WARNING! Incorrect results may occur due to wrong

calibration.
When changing the concentration value of a calibrator,
the calibration curve might be updated even before the
calibration measurement is performed.
10 Recalibrate all tests assigned to the calibrator to
obtain a lot calibration for the existing reagent lot and
for any previously registered reagent lots still in use.
• You must recalibrate all reagent cassettes currently
in use as well as those temporarily unloaded.
• If you want to change the number of decimal places,
choose Utility > Application > Range instead of
changing the concentration values.
11 Perform a QC measurement for the test.
u Related topics
• Defining decimal places (737)
• Deleting calibrator data (493)
6 Calibration

positions (494)
Roche Diagnostics
Calibration 493
Deleting calibrator data

Before you download a new calibrator lot, you can delete
the calibrator data of existing calibrator lots.

However, if the measurement unit changes with the
download, you must delete the corresponding application
before updating. That way you ensure that the new data is
installed properly.

r To delete calibrator data
1
2 From the left list, choose the corresponding calibrator.

I Do not delete the calibrator H20 (Code 901).
3
3 Choose the Delete button and confirm the following
message.
u Related topics
6 Calibration
Roche Diagnostics
494 Calibration
Assigning non-barcoded calibrators to rack positions

You can calibrate with barcoded and non-barcoded
calibrators at the same time. If you work with a non-
barcoded calibrator, or if the barcode cannot be read, you
must assign the calibrator to a rack ID and rack position.
q You cannot work with a mixture of barcoded and non-

barcoded containers on the same rack. Putting a barcoded
container on a manually assigned position, blocks the
measurement.
If you must manually assign a calibrator or QC container
(for example, due to an unreadable barcode), do not place
any container with a barcode in a manually assigned
position.
o Do not assign a position for a barcoded container.
o Assign a position for a non-barcoded container only.
o Assign separate racks for multi-calibrators (e 801
module) and single calibrators.
o Load e 602 calibrators and e 801 calibrators onto
separate racks.
You can view the current calibrator rack ID and rack

position assignments in Calibration > Calibrators.
r To assign non-barcoded calibrators

to rack IDs and rack positions
1
1 Choose Calibration > Calibrators.
6 Calibration
2
2 Choose the Rack Assign button.
Roche Diagnostics
Calibration 495
3
3 In the left list, choose a non-barcoded calibrator.
4
4 In the right list, choose a free rack ID and rack position.
• For e 801 and e 602 modules: Place all calibrators
for one test on the same rack and position them
next to each other.
• For ISE modules: Place all ISE calibrators on the
same rack and position them in the following order:
(ISELOW) directly before ISE Standard High
(ISEHIGH), and ISE Standard High (ISECOMP) after
ISE Standard High (ISEHIGH).
6
6 If you want to cancel an existing assignment, perform
the following steps:
• From the right list, select the assigned rack ID and
rack position.
• Choose the Remove button.
7 To save the changes, choose the OK button.
u Related topics
Setting calibration auto-masking

If a test has no valid calibration and the calibration auto-
6 Calibration
masking function is set, the test is masked. You must

calibrate this test. When the test has been calibrated
successfully, the test is unmasked automatically.
A test can be masked separately for each particular

module.
First, you must set the calibration auto-masking function

for the entire instrument. Then, you can set the calibration
auto-masking function for each test individually.
Roche Diagnostics
496 Calibration
If calibration auto-masking is set, a test is masked

automatically in the following cases:
• Failed calibration
• Invalid calibrations if there is a changeover calibration
request
In Workplace > Test Selection, masked tests are displayed

with a purple bar on the corresponding buttons.
On cobas e modules, a test is masked if the test has no

valid calibration before starting operation.
However, if a test loses valid calibration after starting
operation, for example by failed calibration, the test which
has been pipetted before masking continues to be
analyzed. The data alarm Cal.E is added to the result.
Auto-masking off
If calibration auto-masking is not activated, this test is

measured and a data alarm is attached to the result.
Calibrate the test.
However, no data alarm is attached to the result if

changeover calibration is set for reagent cassette
changes. After a reagent cassette changeover takes
place, you must calibrate the test.

m You need administrator access rights.
r To set calibration auto-masking for

the entire instrument
1
1 Choose Utility > System > Calib. and QC Settings.
6 Calibration
Roche Diagnostics
Calibration 497
2
2 Select the Auto. Masking check box.
r To set calibration auto-masking for

each test individually
1
1 Choose Utility > Application > Calib..
2 From the left list, choose the test to be configured.
3
3 Select the Auto. Masking check box.
6 Calibration
Roche Diagnostics
498 Calibrating tests on the ISE and cobas c modules
Calibrating tests on the ISE and cobas c

modules
In this section
About loading photometric and ISE calibrators (498)
About calibration of photometric tests (499)
Loading calibrators for photometric and ISE tests (499)
About loading photometric and ISE calibrators

To make sure that calibration is performed, you must follow
certain rules when loading the calibrators. There are
different rules for different modules.
The following rules are valid for both photometric and ISE
modules:
• Calibrators are positioned in black calibrator racks.
• Calibrator racks must be loaded in series on the
instrument.
• Calibrator racks for two or more modules can be
sequenced for the individual modules.
• Barcoded and non-barcoded calibrators must be
positioned on separate racks.
• Standard containers are used as calibrator containers.
• Micro cups may not be used as calibrator containers.
• The standard containers can be mixed within a rack.
ISE calibrators If you load ISE calibrators, you must place all ISE
calibrators on the same rack and position them in the
following order: ISE Standard Low directly before
ISE Standard High (S2), and ISE Standard High (S3) after
ISE Standard High (S2).
u About ISE reagents (316)
6 Calibration
Roche Diagnostics
Calibrating tests on the ISE and cobas c modules 499
About calibration of photometric tests

To guarantee a smooth test workflow, all tests must have a
valid calibration on each module.
Lot and cassette calibration If you calibrate a reagent cassette that has been in the
instrument for less than 24 hours, the calibration is valid
for all reagent cassettes belonging to the same reagent lot
(lot calibration).
A lot calibration is module-specific. On the same module, a

lot calibration can be transferred to a newly loaded
reagent cassette with the same test and lot number under
the listed conditions:
• The reagent cassette has been registered at the same
time or later than the reagent cassette with the existing
lot number.
• No QC has been performed with the reagent cassette.
• No sample pipetting has been performed with the
reagent cassette.
If you calibrate a reagent cassette that has been in the

instrument for more than 24 hours, the calibration is only
valid for the particular reagent cassette (cassette
calibration).
Loading calibrators for photometric and ISE tests

You can use barcoded or non-barcoded calibrators. To
ensure correct pipetting, the calibrators must be placed
correctly in the calibrator racks before loading.
There are 2 types of calibrators:

• Calibrators that come in vials and are ready to use.
• Calibrators that must be prepared according to the
Instructions for Use before use, for example, lyophilized
calibrators.
6 Calibration

d m Calibrators
Roche Diagnostics
500 Calibrating tests on the ISE and cobas c modules
j m The green status indicators at the rack input buffer are

lighting.
r To load calibrators for photometric

and ISE tests
1
1 If necessary, prepare the calibrators in standard
containers according to the Instructions for Use.
I Do not use expired calibrators.
2
2 If you want to use barcoded calibrators, label the
calibrator containers:
• From the calibrator kit, take the correct barcode
label.
• Label the barcode onto the calibrator container.
3
3 If you use calibrators without barcode, assign each
calibrator to a rack ID and rack position.
I Place non-barcoded calibrators correctly in the
rack to the assigned rack ID and rack position.
6 Calibration
4
4 Print a load list.
Roche Diagnostics
Calibrating tests on the ISE and cobas c modules 501
5
misplaced ISE calibrators.
Place ISE Standard Low (S1) directly before
ISE Standard High (S2), and ISE Standard High (S3)
after ISE Standard High (S2) on the same rack.
5 According to the calibration load list, position the
calibrator containers correctly in black calibrator racks:
• Ensure that the center of the barcode label and the
open slot of the calibrator rack are in line.
• Place calibrators for the same test next to each
other in the rack.
• Do not place barcoded and non-barcoded
containers on the same rack.
6
7
I Only load or unload racks when the green status
u Related topics
6 Calibration
Roche Diagnostics
502 Calibrating tests on the cobas e modules
Calibrating tests on the cobas e modules

cobas e modules are e 801 modules or e 602 modules.
In this section
About loading calibrators for immunology tests (506)
Loading calibrators for immunology tests (508)
About calibration of immunology tests

To guarantee a smooth test workflow, all immunology tests
must have a valid calibration.
Each module and measuring channel must be calibrated

separately. If there are 2 measuring channels to be
calibrated, both are calibrated with the same calibrator.
Lot and cassette calibration If you calibrate a reagent cassette that has been loaded on
the instrument for less than 24 hours, the calibration is
valid for all reagent cassettes belonging to the same
reagent lot (lot calibration).
Exception: Some immunology tests require a cassette

calibration even though the reagent cassettes are of the
same lot. The cassette calibration is only valid for the
particular reagent cassette.
For these tests, in Utility > Application > Calib., the Reagent
Pack check box for changeover must be selected.
A lot calibration is module-specific. On the same module, a

lot calibration can be transferred to a newly loaded
reagent cassette with the same test and lot number under
the listed conditions:
• The reagent cassette has been registered at the same
time or later than the reagent cassette with the existing
lot number.
• No QC has been performed with the reagent cassette.
• No sample pipetting has been performed with the
6 Calibration
reagent cassette.
If you calibrate a reagent cassette that has been loaded on

the instrument for more than 24 hours, the calibration is
only valid for the particular reagent cassette (cassette
calibration).
Calibration method Immunology tests are calibrated with the full calibration
method.
Roche Diagnostics
Calibrators All calibrators must be mounted on black calibrator racks.
You can install up to 100 calibrators and up to 10 different

lots per assay. To install a calibrator, you must download
the calibrator data via the data manager.
Barcoded calibrator vials for immunology tests can be

used for a maximum of 4 calibrations.
There are 2 types of calibrators:

• Calibrators that come in vials and are ready to use.
• Calibrators that must be prepared according to the
Instructions for Use, and then transferred to empty
calibrator vials, for example, lyophilized calibrators.
For immunology tests, routine and inpack calibrators are

used:
• Routine calibrators are identified by the calibrator
code. The lot numbers of calibrator and reagent
cassette must not correspond.
• Inpack calibrators are delivered within the reagent
package. They are identified by the calibrator code and
the lot number. The lot number of calibrator and
reagent cassette must correspond.
Calibrator set All calibrators necessary for one immunology test.
Calibration masking You can activate calibration masking for the entire
instrument and separately for each test. Only tests with a
valid calibration are measured. Tests with a failed
calibration are masked.
If calibration masking is not activated, the test is measured

and a data alarm is attached to the results.
A test can be masked separately for each particular

module, or measuring channel.
In this section
6 Calibration
Roche Diagnostics
About calibration of tests on the e 801 module

A reagent cassette on the e 801 module can have up to
4 different ACNs corresponding to 4 different tests. A test
can be a single test or a test embedded in a testing
process (cobas e flow test).
Each test must have a valid calibration. On the e 801

module, an individual test of a reagent cassette has a valid
calibration if the test is calibrated successfully, or if the
valid calibration is copied from the master application
(copy calibration).
cobas e flow tests A cobas e flow test combines several embedded tests in a
defined testing process.
All embedded tests must have a valid calibration. They
have to be calibrated individually or the calibration curve
of a master application can be copied to an additional
application.
You must calibrate all embedded tests individually. You

cannot calibrate cobas e flow test as a whole.
Copy calibration Depending on the test, you can use up to 4 different ACNs
with one reagent cassette.
Copy calibration
1 2 3
Up to four (4) applications &opy calibration data to
&alibration measurement
assigned to reagent cassette additional applications
Master application Master application

When calibrating, one code is the master application, the

other codes of the same test and the same reagent
cassette are additional applications. The calibration
6 Calibration
results of the master application are automatically copied

to the additional applications. In Calibration > Status in the
Calib. Type column, a copied calibration is marked with
Copy- before the test name of the master application.
The master application and all additional applications must

use the same measurement unit. If you change the
measurement unit for one application, you must change it
for all corresponding applications. This is necessary to
enable copy QC on the data manager because the
additional applications use the same control ranges.
Roche Diagnostics
Calibrators Calibrators for the e 801 module are single or multi-

calibrators:
• A single calibrator is used for one specific ACN.
• A multi-calibrator is used for multiple ACNs.
Calibration method The number of used calibrators and the calibration quality
criteria differ for qualitative and quantitative tests:
• For the calibration of qualitative tests, 2 calibrators are
used.
• For the calibration of quantitative tests, on all modules
except the e 801 module two calibrators are used. On
the e 801 module, 2, 4, or 5 calibrators are used to
calibrate quantitative tests.
With multi-calibrators, also 2-point, 4-point, and 5-point-

calibration are supported.
Calibrator set All calibrators necessary for one immunology test. Single
calibrators or multi-calibrators can build a calibrator set.
Single and multi-calibrators cannot be mixed in one
calibrator set.
Calibration masking If one application of a linked kit or linked test is masked, the
entire linked kit or linked test is masked.
u Related topics
• Setting calibration auto-masking (495)
• Overview of calibration quality criteria for immunology
tests (1981)
About calibration of tests on the e 602 module

If an individual test of a reagent cassette is calibrated
successfully on the e 602 module, it has a valid calibration.
Calibrators Calibrators for the e 602 module are single calibrators.

6 Calibration
Roche Diagnostics
About loading calibrators for immunology tests

To make sure that calibration is performed, you must follow
certain rules when loading the calibrators. There are
different rules for different modules, for calibrator sets,
and for single/multi-calibrators.
The following rules are valid for both the e 801 module and
the e 602 module:
• Calibrators are positioned in black calibrator racks.
• Calibrator racks must be loaded in series on the
instrument.
• Calibrator racks for two or more modules can be
sequenced for the individual modules.
• Barcoded and non-barcoded calibrators must be
positioned on separate racks.
e 801 modules Since the system differs between single and multi-
calibrators when operating calibrator racks, you must
position multi-calibrators and single calibrators on
separate racks. Otherwise, calibration is not performed
and an instrument alarm is issued.
Calibrator sets on e 801 modules You must position a set of single calibrators in consecutive
positions on one rack.
A set of multi-calibrators must be positioned as described

below:
• No consecutive order is required.
• Distribution on different racks is possible.
• Empty rack positions between the set of multi-
calibrators are possible.
• No other calibrators between the set of multi-
calibrators are allowed.
6 Calibration
Roche Diagnostics
Example 1: Calibration with a calibrator set of multi-

Cal 1 Cal 2 calibrators (Calibrator 1 and Calibrator 2) is requested for
Code: 12221 Code: 12221
5 tests (ACN1-5) on both measuring cells. Assuming a
Lot: 234567 Lot: 234567
maximum of 4 calibrations per vial, you must load 3 vials of
each calibrator to perform the 10 calibrations. The graphic
1 2 shows a possible loading position of the calibrator sets.
Reference No.: 0 Reference No.: 1
$&1¬/HYHO¬ $&1¬/HYHO¬
$&1¬/HYHO¬ $&1¬/HYHO¬
$&1¬/HYHO¬ $&1¬/HYHO¬
$&1¬/HYHO¬ $&1¬/HYHO¬
$&1¬/HYHO¬ $&1¬/HYHO¬
2 1 2 1 2 1
$&1¬ $&1¬ $&1¬

+ +
$&1¬ $&1¬
Example 2: Calibration with a calibrator set of multi-

calibrators (Calibrator 1, Calibrator 2, and Calibrator 3) is
&DO &DO &DO
&RGH &RGH &RGH requested for 2 tests (ACN1+2) on 2 measuring cells.
/RW /RW /RW Assuming a maximum of 4 calibrations per vial, you must
load one vial of each calibrator to perform the
4 calibrations. The graphic shows a possible loading
position.
5HI1R 5HI1R 5HI1R
$&1¬/HYHO¬ $&1¬/HYHO¬ $&1¬/HYHO¬

$&1¬/HYHO¬

$&1¬
$&1¬
$&1¬
+
$&1¬
FREDV¬H¬SDFNV
6 Calibration
e 602 modules You can position calibrators for different tests in any order.
Calibrator sets on e 602 modules You must position a set of single calibrators next to each
other on one rack.
You cannot use multi-calibrators.
Roche Diagnostics
Loading calibrators for immunology tests

The calibrators for immunology tests must be in calibrator
vials, either barcoded, or non-barcoded with assigned rack
positions. Some calibrators are ready for use, some must
be prepared according to the Instructions for Use. To
ensure correct pipetting, the calibrator vials must be
placed correctly in the calibrator racks before loading.
You can load calibrators for immunology tests on the e 801

module or on the e 602 module.
Calibrators on the e 801 module can be single or multi-

calibrators. Single and multi-calibrators must be positioned
on different racks.
Calibrators on the e 602 module are single calibrators.
Do not place calibrators for e 801 and e 602 modules on

the same rack.

d m Calibrators for immunology tests
j m The green status indicators at the rack input buffer are

lighting.
r To load calibrators for immunology

tests
1
1 If necessary, prepare the calibrators in calibrator vials
according to the Instructions for Use.
I Do not use expired calibrators.
6 Calibration
Roche Diagnostics
2
2 Label the calibrator vials:
• Take the correct yellow barcode label with the dual
barcode from the calibrator kit.
• Label the barcode onto the calibrator vials.
3
3 Print a calibration load list.
4
4 According to the calibration load list, position the
calibrator vials correctly in black calibrator racks:
• Manually open the lids of the calibrator vials.
• Make sure that the center of the dual barcode on
the yellow barcode label and the open slot of the
calibrator rack are in line.
• Make sure that the open lid does not overlap the
rack.
• Make sure that the position of the open lid is vertical
to the rack.
• Place calibrators for the same test next to each
other in the rack.
• For e 801 modules: Position multi-calibrators and
single calibrators on separate racks.
I Empty rack positions between multi-calibrators are
possible.
5
6 Calibration
Roche Diagnostics
6
I Only load or unload racks when the green status
u Related topics
6 Calibration
Roche Diagnostics
511
Table of contents
Quality control 7
In this chapter 7
About quality control (QC) . . . . . . . . . . . . . . . . . . . . . . . 513
About QC types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515
About automated third-party QC materials . . . . . . . . . 517
Performing routine QC . . . . . . . . . . . . . . . . . . . . . . . . . . 519
Performing QC for standby reagents . . . . . . . . . . . . . . 521
Performing timeout QC . . . . . . . . . . . . . . . . . . . . . . . . . . 523
Performing QC after calibration. . . . . . . . . . . . . . . . . . . 525
Performing manual QC . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Checking QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Installing QC material data from the data manager . . 531
Deactivating tests for QC material . . . . . . . . . . . . . . . . 534
Assigning non-barcoded QC material to rack
positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535
Unloading auto QC racks from the auto QC
compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
7 Quality control
Roche Diagnostics
512
Table of contents
7 Quality control
Roche Diagnostics
About quality control (QC) 513
About quality control (QC)

The purpose of QC measurements is to monitor the
instrument performance. You can perform QC
automatically or manually.
Auto QC racks It is possible to keep QC racks in the auto QC

compartment, in the module sample buffer. The instrument
can use auto QC racks for automatic QC measurements at
any time.
QC samples for auto QC measurements are defined by a

range of rack IDs. You specify the range on Utility > System
> Rack Assignment.
An asterisk (*) in the second column of the QC > Status

submenu indicates which QC materials are used as
automatic QC and are loaded onto the instrument.
Manual QC request QC measurements are typically requested manually. There

are different reasons to perform manual QC
measurements:
• If a QC measurement must be performed and there are
no suitable QC materials in the auto QC compartment.
• If a QC result is out of range, you can perform the QC
measurement again.
• At the end of an operation, you can perform QC
measurements for those tests on which you have been
working.
Automatic QC request Depending on the configuration, QC measurements can be

requested automatically by the system. If a QC rack with
the suitable QC material is in the auto QC compartment,
the system performs QC measurements without any
further request.
Validation of QC After measurement of QC samples, the results are

displayed on the Workplace > Data Review submenu and
transferred to the data manager. On the data manager, QC
7 Quality control
statistics are calculated. The validated QC results are

transferred back to the control unit and displayed on the
QC > Run Status submenu.
u Refer to the QC routine component in the data
manager.
Suitable containers for QC samples All QC samples must be loaded in white QC racks only.
u Specifications of containers (2031)
Roche Diagnostics
514 About quality control (QC)
Barcoded or non-barcoded QC QC material can be used either with or without barcodes.
Do not mix barcoded and non-barcoded QC material within

a rack. Be consistent with the settings on QC > Controls.
Do not mix different container types, such as standard

containers, non-standard tubes, or false bottom tubes. Be
consistent with the settings on Utility > System > Rack
Assignment.
Expired QC lots If a QC lot is expired, you cannot use it any more.
QC for cobas e flow tests (e 801 module) You cannot perform a QC measurement for a whole
cobas e flow test. You must always request QC
measurements for each embedded test.
Copy QC (e 801 module) For the e 801 module, you can assign one reagent to multi-
applications. Each application needs a valid QC. Copy QC
means that the data manager applies QC results of the
master application to up to 3 additional ACNs of the same
application.
You can view the results of the copy QC on the data

manager, but not on the QC > Run Status submenu. Copy
QC is possible for current and standby reagent cassettes.
Calculated QC (e 801 module) Linked kits and linked tests may provide a calculated QC
result. This QC result is based on individual tests from the
same lot and the same run. QC calculation is only
successful if QC results are available for all individual QC
tests.
u Related topics
• Performing routine QC (519)
• Performing QC for standby reagents (521)
• Performing timeout QC (523)
• Performing QC after calibration (525)
• Performing manual QC (527)
7 Quality control
Roche Diagnostics
About QC types 515
About QC types
To perform automatic or manual QC, you can use
5 different QC types for different cases.
In the following cases, you must perform QC

measurements:
• Each day before operation and at the end of operation
to ensure measurement accuracy during the entire
operation.
• When a new reagent cassette is loaded to check the
reagent.
• After troubleshooting to check the instrument
performance.
In addition, you can perform QC measurements anytime

during routine operation. To do that, you select the QC
types that meet the requirements of your workflow.
The following table shows, at which phase you typically

perform which QC type during a work shift but they can be
performed at any time:
Routine QC Standby bottle QC after Timeout QC Manual QC

QC calibration
Automatic QC requests l(1) l l
Manual QC requests l l l
At the beginning
Phase during work shift During workshift
At the end
y QC types for automatic and manual QC requests

(1) On c 702 and e 801 modules only.
Routine QC With routine QC, you can request QC measurements for all
7 Quality control
reagent cassettes that are in use. Routine QC comprises

all activated tests of all installed QC materials and is
usually performed before operation.
Roche Diagnostics
516 About QC types
Standby bottle QC With standby bottle QC, you can request QC

measurements for standby reagents manually. Standby
reagents are reagent cassettes that are already on board
but not in use.
For standby reagents, we recommend requesting QC

measurements together with the routine QC at the
beginning of a work shift. In this case, you do not need to
perform a QC measurement during operation when the
status of the standby reagent changes.
On the c 702 and e 801 modules, the instrument can

perform standby bottle QC measurements automatically,
on loading a new standby reagent cassette. To achieve
this, on the Utility > System > Calib. and QC Settings
submenu, you must select the Auto. QC Request to Loading
R. Pack check box.
QC after calibration If you place a QC rack (white) directly after a calibrator

rack (black), QC measurements are requested for the
calibrated tests. If a QC rack with suitable QC material is in
the auto QC compartment, the instrument automatically
performs the requested QC measurements.
Timeout QC QC measurements can be performed at predefined (test-

specific) time intervals. When the time interval has elapsed,
the system issues a recommendation for a QC
measurement. This recommendation is indicated in the
Overview menu by the Calib. and QC Select button turning
yellow.
On the QC > Status submenu, the word Timeout in the

Cause column also indicates a recommendation for a QC
measurement.
If a QC rack with suitable QC material is in the auto QC

compartment, the instrument automatically performs
necessary QC measurements for the active reagent
cassettes.
Manual QC QC measurements can be requested manually for a single

7 Quality control
test or for multiple tests. For example if a QC measurement

fails, select this QC material on the QC > Status submenu
and start a new QC measurement.
On the QC > Status submenu, the word Manual in the Cause

column indicates a manual QC request.
u Related topics
• Performing routine QC (519)
• Performing QC for standby reagents (521)
• Performing timeout QC (523)
• Performing QC after calibration (525)
Roche Diagnostics
About automated third-party QC materials 517
About automated third-party QC materials

Automated third-party QC materials are non-Roche QC
materials where the parameter file is downloaded from
cobas® link. The system handles automated third-party QC
results in the same way as QC results from Roche QC
materials provided that you observe specific rules for rack
loading and container type.
Automated third-party QC materials can be used on

multiple systems throughout the laboratory.
Limitation: The e 602 module does not support automated

third-party QC materials.
Container types and barcodes
For both clinical chemistry and immunology tests, use only

the original ∅13 mm x 75 mm tubes that the automated
third-party QC materials come in.
• The system automatically recognizes the original third-
party barcoded tubes so you can use automated third-
party QC materials without the need for additional
settings.
• If the original barcode is damaged or unreadable, use
the original tube as if it was a non-barcoded tube and
manually assign the rack ID and position.
QC racks Always use separate QC racks for automated third-party

QC materials.
Do not load different QC material types (automated third-

party QC, Roche QC, non-Roche QC) on the same rack. In
this case the system generates an alarm, unloads the rack,
and QC measurement does not take place.
Automatic QC container changeover If the remaining volume in a single tube of an automated

third-party QC material is insufficient to conduct all QC
measurements, before the run, load a second tube of the
7 Quality control
same lot into the next position on the same rack. Do not
leave an empty rack position between the two tubes of the
same material and lot. The analyzer automatically pipettes
from the second tube when the first tube runs empty.
Note: Automatic QC changeover rules do not apply to auto

QC racks.
Roche Diagnostics
518 About automated third-party QC materials
Download of parameter file Download the parameter file for the automated third-party
QC material from cobas® link.
q If for a specific assay the target value or QC range of

an automated third-party QC material is incompatible with
the system, determine and overwrite with custom values in
the data manager, if appropriate, to permit QC evaluation.
7 Quality control
Roche Diagnostics
Performing routine QC 519
Performing routine QC
Each test has one or more QC materials assigned to it.
Routine QC comprises all activated tests of all installed QC
materials for the selected modules.
If you do not want to perform a QC measurement for a test,

you can inactivate this test.
u Deactivating tests for QC material (534)

c At the beginning of a work shift
d m QC material
r To perform routine QC
1
1 Choose QC > Status.
2 Choose a module from the Module drop-down list.
7 Quality control
3
3 Choose the Routine QC Assign button.
f All rows are selected.
4 To request the selected QC material for measurement,

choose the Save button.
5 Print the QC load list.
Roche Diagnostics
520 Performing routine QC
6
6 Load the QC material onto the instrument, as directed
by the QC load list.
8
8 On QC > Run Status, check the QC results.
• If one QC result is out of range, you must check the
QC material, the instrument, or the reagent.
hold back the sample results until the cause for the
wrong QC results is known.
u Related topics
7 Quality control
Roche Diagnostics
Performing QC for standby reagents 521
Performing QC for standby reagents

You can perform QC measurements for standby reagents.
Standby reagents are reagent cassettes already on board,
but not currently in use.

c • At the beginning of a work shift, together with routine

QC.
• During operation if you have loaded a new reagent as a
standby reagent onto the instrument. On the c 702 and
e 801 module a QC is performed automatically if a
suitable QC material is in the auto QC compartment.
d m QC material
j m The instrument is in Operation mode or in Standby

mode.
r To perform QC for standby reagents
1
1 On QC > Status, choose the Stand By Bottle QC button.
2 In the Select column, select the row containing the

7 Quality control
2
desired module, test, and QC material. You can select
multiple rows.
3 To request the selected QC material for measurement,

choose the OK button.
Roche Diagnostics
522 Performing QC for standby reagents
5
7
u Related topics
7 Quality control
Roche Diagnostics
Performing timeout QC 523
Performing timeout QC
The instrument recommends timeout QC when the
predefined test-specific time interval has elapsed. You
must perform the recommended QC measurements.
The recommendations for timeout QC are bundled

together in QC events. After operation has been started,
once every hour the instrument requests the timeout QC
from the QC events. If suitable QC materials are in the auto
QC compartment, the requests are performed
automatically.

d m QC material
r To perform timeout QC
1
1 From the Overview menu, choose the Calib. and QC
Select button if it is highlighted in yellow.
2
2 In the QC group box, do the following:
• Choose the Recommended button.
• Choose the Load List Print button.

7 Quality control
Roche Diagnostics
524 Performing timeout QC
4
6
u Related topics
7 Quality control
Roche Diagnostics
Performing QC after calibration 525
Performing QC after calibration

You can perform QC measurements after calibration
automatically. To do that, you must load QC racks with
suitable QC material onto the instrument directly after the
calibrator racks. The instrument can automatically perform
QC after calibration if QC racks with suitable QC material
are in the auto QC compartment.

c • At the beginning of a work shift if a calibration is

necessary.
• During operation, when a new reagent cassette with no
valid calibration is loaded onto the instrument.
r To perform QC after calibration
1
1 In the Overview menu, choose the Calib. and QC Select
button.
2
2 In the Calibration group box, do the following:
• Choose the Recommended button.
• Choose the Load List Print button.
7 Quality control
3
3 In the QC group box, choose the Load List Print button.
4 Print the calibrator load list and the QC load list.
Roche Diagnostics
526 Performing QC after calibration
5
5 Load the calibrator and QC racks onto the instrument,
as directed by the calibrator load list and the QC load
list.
7
7 On Calibration > Status, check the calibration results.
regulations.
tests.
8
QC material, the system, or the reagent.
u Related topics
7 Quality control
Roche Diagnostics
Performing manual QC 527
Performing manual QC
You can perform manual QC measurements for single tests
or multiple tests on the QC > Status menu.

c At any time:
• If you want to perform QC only for some individual
tests.
• If a QC result is out of range, you can perform this QC
measurement again.
j m The instrument is in Operation mode or in Standby

mode.
r To perform manual QC for individual

tests
2
2 In the Select column, select the row containing the
desired module, test, and QC material.
f In the Cause column, Manual is displayed.
3 To request the selected QC materials for

measurement, choose the Save button.

7 Quality control
5
5 Load the racks with the QC materials onto the
instrument, as directed by the QC load list.
Roche Diagnostics
528 Performing manual QC
7
QC material, the system, or the reagent.
u Related topics
7 Quality control
Roche Diagnostics
Checking QC results 529
Checking QC results
On the QC > Run Status submenu, you get a complete
overview of whether your QC results are within the
corresponding limits. The results are calculated on the
data manager before they are transferred back to the
control unit.
The QC results must be within the limits of ± 3 SD, except

for the standby bottle QC of the cobas c modules. These
results must be within ± 2 SD.
If the QC results are within the QC limits, everything is in

order with the QC material, the reagent, and the
instrument. If the QC results fall out of the QC limits, you
must check the QC material, the reagent, and/or the
system. If most of the QC results are out of range, you
must hold back the sample results until the cause for the
Asymmetric QC (e 801 module) Asymmetric QC means, that the upper and lower limit of
the QC results can be different. These limits are defined as
absolute values, not as QC limits, so that asymmetric limits
can be defined for the upper and lower limit. The control
parameter file defines if symmetric or asymmetric QC is
used for the test. You cannot change this setting.
To view whether symmetric or asymmetric QC is used, refer

to the QC material component on the data manager. The
values of the limits are shown on the Run Status screen.
r To check QC results on QC > Run

Status
1
1 Choose QC > Run Status.
2 From the Test drop-down list, choose one of the

following options:
7 Quality control
• To view the results of the last 500 QC

measurements, choose the All option.
• To view the results of a test, choose the
corresponding test.
Roche Diagnostics
530 Checking QC results
3
3 Check if all QC results are displayed in green (today’s
QC results within the SD limits).
4 If a QC result is displayed in red (today’s QC results

outside the SD limits), perform the following:
• Check whether the QCErr data alarm occurred.
• Perform the remedies described.
• Repeat the QC measurement.
u Related topics
• Data alarm for QC materials (1221)
7 Quality control
Roche Diagnostics
Installing QC material data from the data manager 531
Installing QC material data from the data

manager
If you use a new QC lot, you must install the data of the
newest release version. You can download the QC material
data for all available applications to the instrument from
the data manager. If QC material data have been changed
by Roche, download the updated target values.
If the Parameter Download button in the Overview menu

changes color, new target values for a QC material are
available. In this case, you must update the QC values on
the instrument with a download from the data manager.
The new QC values overwrite the old QC values after
confirmation.
You cannot add QC material manually to the instrument.

You must always download the QC material data from the
data manager using the Download button.
You can install up to 100 QC materials on the instrument.

For non-Roche QC material, you must use the QC material
component on the data manager.

Administrators can download the QC material data of a
new QC material, of a new QC lot, or the newest version
of an installed QC lot.
Supervisors can download the QC material data for the
newest version of a QC lot or for a different QC lot with
the same QC catalog number.
r To download QC material data from

the data manager
7 Quality control
1
1 Choose QC > Install.
Roche Diagnostics
532 Installing QC material data from the data manager
2
3
3 In the Search Using group box, choose one of the
available search options, for example:
• Required Item option: QC materials that are on
board but for which the QC material data was not
yet downloaded.
• Lot ID option: Recommended search option. Always
enter 8 digits. The last 2 digits are zeros
(XXXXXX00).
4 To start searching for the selected criteria, choose the

Search button.
f In the Result group box, the search results are
displayed.
5
5 In the Selection column, select the list item to be
downloaded.

f The Confirmation dialog box is displayed. It shows
the module types for which the QC material is
available.
7
7 Check and complete the following settings:
• Current Release Date field: Refers to the QC lot
currently on board. This is only available if you
request the same QC lot for download.
• Addition Release Date option: Shows the date of the
release that will be newly installed.
Choose the None option from the drop-down list if
7 Quality control
you want to skip downloading the parameters for a

specific module.
• Update Release Date option: Only displayed if you
update an existing QC material data.
8 To confirm the settings and to download the QC

material data, choose the OK button and follow the
instructions on the screen.
Roche Diagnostics
Installing QC material data from the data manager 533
9
9 To return to the QC > Install submenu, choose the Close
button.
10 Verify whether the downloaded information has been

registered correctly.
11
11 If you do not want to perform all tests with the newly
installed QC material, inactivate these tests.
u Related topics
• Deactivating tests for QC material (534)
• Installing applications (704)
• Searching for QC Value Sheets for systems connected
to a LIS (252)
7 Quality control
Roche Diagnostics
534 Deactivating tests for QC material
Deactivating tests for QC material

All tests on board are automatically activated once the QC
material data is installed. If you do not want to perform a
QC measurement for a test, you can manually deactivate
this test.
c After installing QC material data

r To deactivate tests for QC material
1
1 Choose QC > Install.
2 From the left list, choose the appropriate QC material

name.
3
3 From the right list, choose the test to be deactivated.
I An activated test is highlighted in blue.
4
4 Choose the Inactivate Test button.
f The Inactivate Test button toggles to Activate Test.
7 Quality control
5 Repeat steps 2 to 4 for all QC materials.
Roche Diagnostics
Assigning non-barcoded QC material to rack positions 535
Assigning non-barcoded QC material to

rack positions
If you work with non-barcoded QC material, you must
assign each QC material to a rack ID and rack position. QC
> Controls shows the current rack position assignment.

q If you work with non-barcoded QC material, ensure

correct positions of the QC material.
Assign a rack ID and position for a non-barcoded container
only.
r To assign rack positions to QC

material
1
1 Choose QC > Controls.
2
2 Choose the Rack Assign button.
7 Quality control
Roche Diagnostics
536 Assigning non-barcoded QC material to rack positions
3
3 If you want to register a new assignment, perform the
following steps:
• From the left list, choose a QC material.
• From the right list, choose an unassigned rack ID
and rack position.
• Choose the Add button.
4
4 If you want to remove an existing assignment, perform
the following steps:
• From the right list, choose the assigned rack ID and
rack position.
• Choose the Remove button.
5 To save the changes, choose the OK button.
u Related topics
7 Quality control
Roche Diagnostics
Unloading auto QC racks from the auto QC compartment 537
Unloading auto QC racks from the auto QC

compartment
When an auto QC sample has expired, you unload the auto
QC rack manually. Replace the expired QC material and
reload the rack onto the instrument.
Only when the auto QC onboard stability has expired for all
QC samples on the rack, the instrument unloads the auto
QC rack automatically.
If the onboard stability set on the Utility > Application

> Range submenu is expired for a QC material, the system
issues a yellow alarm. Additionally, on the QC > Status
submenu, the * column (second column) of the
corresponding QC material turns yellow. No measurements
are performed with QC material from auto QC racks whose
onboard stability has expired.
Priority of QC materials If there is more than one QC material of one lot available
for a QC measurement, the instrument uses the QC
material with the longest onboard stability.
r To unload auto QC racks from the

auto QC compartment
1
7 Quality control
2
2 Choose the Unloading button.
Roche Diagnostics
538 Unloading auto QC racks from the auto QC compartment
3
3 Choose the rack(s) to be unloaded.
5 Unload the QC rack.
6 Dispose of the QC samples according to local

regulations.
7 Quality control
Roche Diagnostics
539
Table of contents
Orders and results 8
In this chapter 8
About sample processing . . . . . . . . . . . . . . . . . . . . . . . . 541
About data distribution . . . . . . . . . . . . . . . . . . . . . . . . . . 542
About barcode and non-barcode mode . . . . . . . . . . . . 544
Switching between barcode and non-barcode mode. 546
About the Rack Reception mode . . . . . . . . . . . . . . . . . . 548
Ordering tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
About the Test Selection submenu . . . . . . . . . . . . . 550
About pipetting volumes and dilution factors . . . . 552
Ordering routine samples manually . . . . . . . . . . . . 554
Ordering STAT samples manually . . . . . . . . . . . . . . 555
Checking single registered orders. . . . . . . . . . . . . . 556
Correcting registered orders manually. . . . . . . . . . 557
Working with barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . 559
Placing barcode labels on sample tubes . . . . . . . . 559
Entering unreadable sample barcodes or sample
IDs for non-barcoded samples. . . . . . . . . . . . . . . . . 560
Loading samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 562
About loading samples . . . . . . . . . . . . . . . . . . . . . . . 562
About selecting the right container type and rack
range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 565
About mixing different sample types and
container types on a rack . . . . . . . . . . . . . . . . . . . . . 567
Loading routine samples. . . . . . . . . . . . . . . . . . . . . . 568
Loading STAT samples. . . . . . . . . . . . . . . . . . . . . . . . 570
8 Orders and results
Loading additional samples . . . . . . . . . . . . . . . . . . . 572
Processing samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 574
Starting analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 574
Tracking samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 575
Changing the priority of sample racks . . . . . . . . . . 576
Masking tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 577
Masking tests for every measurement . . . . . . . 578
Masking tests for sample measurement . . . . . . 579
Unmasking tests. . . . . . . . . . . . . . . . . . . . . . . . . . 580
Working with sample results . . . . . . . . . . . . . . . . . . . . . . 581
About the sample selection list . . . . . . . . . . . . . . . . 581
About the test result list . . . . . . . . . . . . . . . . . . . . . . 584
About the Search Sample dialog box . . . . . . . . . . . 585
About the Filter dialog box . . . . . . . . . . . . . . . . . . . . 587
Roche Diagnostics
540
Table of contents
About the Test Review dialog box . . . . . . . . . . . . . . 588

Deleting samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591
Editing a sample result . . . . . . . . . . . . . . . . . . . . . . . 592
Deleting a sample result . . . . . . . . . . . . . . . . . . . . . . 593
Displaying archived sample data . . . . . . . . . . . . . . . 593
Processing rerun tests. . . . . . . . . . . . . . . . . . . . . . . . . . . 595
Processing manual rerun tests. . . . . . . . . . . . . . . . . 595
About processing manual rerun tests in
barcode mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 595
Assigning a sample to a rerun rack in non-
barcode mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 595
Deleting a rerun rack assignment in non-
barcode mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 596
Processing automatic rerun . . . . . . . . . . . . . . . . . . . 597
About automatic rerun . . . . . . . . . . . . . . . . . . . . 597
Activating automatic rerun system-wide. . . . . . 598
Activating automatic rerun for each
application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 599
Unloading samples manually . . . . . . . . . . . . . . . . . . . . . 600
About the Calibration Review submenu . . . . . . . . . . . . 601
About the calibrator selection list . . . . . . . . . . . . . . 601
About the test results list . . . . . . . . . . . . . . . . . . . . . 602
Roche Diagnostics
About sample processing 541
About sample processing

This workflow shows the basic sequence of sample
processing.
Sample processing
Ordering tests
Loading routine samples and

STAT samples
Starting measurement
STAT samples or No
additional samples during
operation?
Performing rerun Yes
Loading STAT samples or

additional samples during
operation
Yes
Results with data alarms?
No
Unloading samples 8 Orders and results
w Sample processing workflow
Roche Diagnostics
542 About data distribution
About data distribution

Data is distributed between the host, the data manager,
and the instrument. The data manager downloads data
over the Internet from cobas® e-services.
Data distribution of the system It can be helpful for you to understand where to find which
information.
The following chart gives a general orientation of the types

of data, their processing, and their distribution.
cobas® e-services
Results Results
• Calibrator • Calibrator Instrument
• QC material • QC material
Host • Sample • Sample
Data manager
Orders Orders
w Data distribution of the system
Online access to the cobas® e-services ensures the

receiving of new data (application settings, calibrator data,
and QC material data) and the update of current data.
Data types and the role of the data manager As part of the overall laboratory workflow, the data
manager processes data in real time between the
instrument and the host of your laboratory.
The following workflow presents an overview about the

types of data, their origin, and their potential target.
Orders Orders Orders

• Sample • Sample • Sample
• QC material
• Calibrator
Results Results Results
• Sample • Sample • Sample
• QC material • QC material • QC material
• Calibrator • Calibrator
Host Data manager Control unit Instrument
Alarms Alarms
• Data alarms • Data alarms
• Instrument alarms • Instrument alarms
w The data manager and its related data distribution
Roche Diagnostics
About data distribution 543
The data manager processes orders from the host and is

able to transfer sample results from the system to the
host.
The data manager manages and displays QC results and

sample results. You can also use the data manager for
traceability purposes.
Roche Diagnostics
544 About barcode and non-barcode mode
About barcode and non-barcode mode

In barcode mode, the instrument uses barcodes to identify
samples. You employ the same barcodes throughout your
whole laboratory workflow to track the samples’ identities.
In non-barcode mode, the instrument identifies samples by
the sequence that you place samples on racks. You must
organize this sequence of the samples manually or with
your host to track the samples’ identities.
Barcode mode Barcodes are used for identifying samples, calibrators, and
QC material. In barcode mode, the barcode number is the
sample ID.
Barcodes for samples can be generated by your

laboratory-wide barcode labeling and printing system.
Barcodes for calibrators and QC material are supplied in-
pack.
To minimize the risk of confusing samples, we strongly

recommend operating the instrument in barcode mode.
If the barcode mode is activated, it is still possible to

process single samples without barcodes. In this case, you
use the Barcode Read Error dialog box to enter a rack ID
and rack position for these samples.
If non-barcoded samples have been aliquoted on a pre-

analytical system, the barcode mode is also used. In this
case, the instrument receives the sample ID, rack ID, and
rack position number together with the test order.
u Specifications of barcodes (2038)
Entering unreadable sample barcodes or sample IDs for
non-barcoded samples (560)
Non-barcode mode The instrument uses an internal worklist to track the

sequence of samples. On the worklist, samples are
sequentially numbered and assigned to racks by rack ID

and rack position.
You can generate a worklist manually by ordering tests on

the Test Selection submenu and entering a sample
sequence number. Also, the worklist can be generated by
the host.
The requisition list represents the internal worklist.
The instrument uses only the sample sequence number to

identify samples. Optionally, you can still assign a sample
ID, which can be text, to help identify samples.
u Ordering routine samples manually (554)
Roche Diagnostics
About barcode and non-barcode mode 545

u Related topics
• Switching between barcode and non-barcode
mode (546)
Roche Diagnostics
546 Switching between barcode and non-barcode mode
Switching between barcode and

non-barcode mode
Before switching from barcode to non-barcode mode or
vice versa, you must delete all affected samples
beforehand from the instrument, from the respective data
manager, and also from the host. Therefore, you must first
evaluate the pros and cons of deleting all samples, and you
must archive all test results.
The sample ID, which is identical to the barcode number in

barcode mode, is used to identify each sample. Each
sample is included in the sample databases of the
instrument, of the data manager, and of the host.
Therefore, you cannot easily switch between barcode
mode and non-barcode mode without risking duplicate
sample IDs in one of the databases.
u About barcode and non-barcode mode (544)

j m You have archived all test results.

m You have determined whether deleting affected
samples from the host is required, and if so, you have
deleted all affected samples from the host.
m You have deleted all samples from the respective data
manager.
u Performing data backup and archiving (610)
Archiving test results (611)
Operator’s Manual of your host
Operator’s Manual of data manager
r To switch between barcode mode and

non-barcode mode
1
1 Choose Workplace > Data Review.
Roche Diagnostics
Switching between barcode and non-barcode mode 547
2
2 Choose the Delete All button and confirm the message
which is displayed.
3
3 Choose Utility > System > Barcode Settings.
4
4 Activate or deactivate barcode mode for samples
(Routine/Stat check box), calibrators (Calibrator check
box), or QC material (Control check box) as required.
Roche Diagnostics
548 About the Rack Reception mode
About the Rack Reception mode

The Rack Reception mode extends the period for which the
system remains in Operation mode after all current
determinations are finished. This function is used if many
sample requests are outside of the routine operation.
! WARNING
Incorrect results may occur due to interruption of
operation
By pressing the Stop button, operation stops on all
modules. Results being processed would be lost! All
pipetted samples would be lost and must be reloaded.
Furthermore, reaction cells would not be washed and, on
e 602 modules, finalization would not be performed.
r To terminate Rack Reception mode, choose the Change
button in the Start dialog box and clear the
corresponding check box. Then the instrument goes
into Standby mode and you may start performing
maintenance, for example.
r Never choose the Stop button to terminate Rack
Reception mode.
The period is specified in the Utility > System > Rack

Reception.
The operator with administrator access rights can set the

period according to the routine workflow policy of the
laboratory.
On The system changes from Operation mode

to Standby mode after passing a specified
period since power-on.
Off The system stops Operation mode and

changes to Standby mode after all current
samples have been processed.
You can restart the system during operation. When the

period of the Rack Reception mode option expires, the
system stops and changes to Standby mode. Only current
sample orders are finished. New sample orders and those
samples that were not started are not processed.
q For instruments without a e 602 module, Rack

Reception mode is no longer necessary. The quick start
mode of the e 801 module reduces the time from Standby
mode to Operation mode to approximately 6:30 minutes.
Roche Diagnostics
About the Rack Reception mode 549
u Related topics
• Activating Rack Reception mode (688)
• About the quick start mode on the e 801 module (696)
Roche Diagnostics
550 Ordering tests
Ordering tests
If you use a host, orders are downloaded from the host. In
addition, you can manually order routine or STAT samples
on the control unit. You can also check and correct orders
manually on the control unit.
In this section
About the Test Selection submenu (550)
About pipetting volumes and dilution factors (552)
Ordering routine samples manually (554)
Ordering STAT samples manually (555)
Checking single registered orders (556)
Correcting registered orders manually (557)
About the Test Selection submenu
Sample ID and sample sequence number In barcode mode, the instrument identifies samples by the
sample ID. In barcode mode, the sample ID corresponds to
the number that is encoded in the barcode.
In non-barcode mode, the instrument identifies samples by

the sequence that the samples are placed on the racks.
The instrument does not use the sample ID in non-barcode
mode to identify the samples. However, you can use the
sample ID also in non-barcode mode as operator-readable
information.
Roche Diagnostics
Ordering tests 551
Racks The instrument identifies priorities, samples (in non-

barcode mode), and sample types through the racks.
Racks are differentiated by classes, for example racks for

A B
routine samples, STAT samples, or rerun samples. To avoid
ambiguity, racks are sequentially numbered. This
numbering is essential for non-barcode mode. Within one
rack class, you can specify rack ranges, ranges of rack IDs,
for different sample types.
You can identify racks by their 4-digit rack ID. In the

software, rack IDs are mapped to a different ID range with
5 digits.
The racks with and without stabilizers share part of the

same rack range. Therefore, only one type can be used
within the same rack range, either racks with or without
stabilizers.
C
The rack positions are numbered 1–5.

A Rack position C Barcoded rack ID
B Operator-readable
If you load a rack into the instrument and another rack with
rack ID
the same rack ID is already being processed, the samples
on the second rack are not processed.
u List of racks with stabilizers (2027)
List of racks without stabilizers (2028)
u Rack assignment (670)
Tests and test profiles On Workplace > Test Selection, the test selection matrix
displays the test keys for selection.
You can freely configure this test selection matrix to your

needs. Test keys can represent single tests or a
combination of tests, which you order in combination
regularly. These combinations of tests are called test
profiles.
q You can view embedded tests for e 801 modules only

on the data manager, but not in Workplace > Test Selection.
u Assigning tests and test profiles to test keys (682)
u Related topics
• About barcode and non-barcode mode (544)
• General specifications of the ISE module (2015)
modules (2018)
• Specifications of the sampling system of cobas e
modules (2022)
• About pipetting volumes and dilution factors (552)
Roche Diagnostics
552 Ordering tests
About pipetting volumes and dilution factors

You can measure tests with pre-defined dilution factors,
with normal, decreased, or increased pipetting volumes, or
with a manual predilution.
Application of pipetting volumes and dilution There are different ways pipetting volumes and dilution
factors factors can be applied:
• Pipetting volumes and dilution factors can be
programmed in the application file and be applied
automatically.
• You can request pipetting volumes and dilution factors
manually.
• Pipetting volumes and dilution factors can be
requested by the host.
• You can predilute a sample manually.
u Operator’s Manual of your host
Operator’s Manual of data manager
Available pipetting volumes and dilution The following pipetting volumes and dilution factors are
factors available:
ISE module cobas c modules cobas e modules

Normal pipetting volume l l l
Decreased pipetting volume – l l(1)
Increased pipetting volume – l l
Diluted sample – l l
y Available pipetting volumes
(1) If Decrease is selected in the Test Selection submenu and in the data manager, the dilution factor defined on Utility > Application > Range is used.
Available dilution factors

For clinical chemistry tests From 1:3 to 1:50
For tests on e 801 modules From 1:1.1 to 1:27 000
For tests on e 602 modules From 1:2 to 1:400
y Available dilution factors
q The option 1:1 from the Sample Volume/Dilution drop-

down list is used to override any pre-configured first run
dilution.
u For recommended dilution factors, refer to the

Instructions for Use of the respective application
Roche Diagnostics
Ordering tests 553
Manual predilution Manually prediluted samples are samples that you have
prediluted before you put the samples on the instrument.
Manual predilution is not to be confused with manually
requested dilution factors. Manually requested dilution is
performed by the instrument.
The dilution factor for a manual predilution is not taken into

consideration. On the printed report, results are shown
with a P. In Workplace > Data Review, there is a mark in the
Dil. column.
Note that the dilution status set on the Data Manager and
the Host should be the same. Otherwise, reports may
contain errors.
It is your responsibility to calculate the final result.
Dilution factors for rerun tests Individual tests can be configured with a dilution for rerun
tests. The instrument automatically performs the dilution
factors pre-defined in Utility > Application. To define these
dilution parameters, you require administrator level
access.
In the following case, the dilution factor that was used in

the first run and the dilution factor that is defined in Utility
> Application > Analyze for the rerun test are compared.
• The first run was measured with a manually requested
dilution, for example, of 1:10.
• Also, the data alarm >Test was generated and caused
an automatic rerun with a pre-defined dilution, for
example, of 1:2.
In this example, the dilution factor of the first run (1:10) is

higher than the application setting for rerun test (1:2).
Therefore, the rerun test is automatically performed with
the higher dilution factor (in this example, 1:10).
Roche Diagnostics
554 Ordering tests
Ordering routine samples manually

Usually, orders are downloaded from the host. In addition,
you can order routine samples manually.

r To order a routine sample manually
1
1 Choose Workplace > Test Selection.
2 From the S. Type drop-down list, choose the sample

type.
3 In the Sample area, choose the Routine option.
4 Depending on whether the instrument is in barcode

mode or non-barcode mode, do one of the following:
• In barcode mode, type the sample ID in the Sample
ID field and press the Enter key.
• In non-barcode mode, type the sample sequence
number in the Sequence No. field and press the
Enter key.
5 If you have manually diluted the sample, select the Pre-

dilution check box.
6
6 From the Sample Cup drop-down list, choose the
container type of the sample.
7
7 If necessary, choose the dilution from the Sample
Volume/Dilution drop-down list.
I This dilution setting refers to the dilution that the
instrument applies, not the manual predilution.
Roche Diagnostics
Ordering tests 555
8
8 Select the desired test keys or test profile keys.
f Selected test keys and test profile keys are
highlighted with a blue border.
u Related topics
Ordering STAT samples manually

STAT orders are downloaded from the host, or you order
STAT samples manually on the control unit.
In barcode mode, samples on the red STAT racks are

identified by the barcode. In non-barcode mode, you
specify the rack ID and rack position for a given sample.
Thus, in non-barcode mode, you must have the red STAT
rack that you want to use at hand when you order the STAT
sample.
Never use STAT samples if you are working in non-barcode

mode.

d m Red STAT rack
r To order a STAT sample manually
1
1 Choose Workplace > Test Selection. 8 Orders and results
type.
3 In the Sample area, choose the STAT option.

• In barcode mode, go to step 7.
• In non-barcode mode, proceed with step 5.
5 In the Rack No. field, type the rack ID of the sample and
press the Enter key.
6 In the Pos. field, type the rack position number of the

sample and press the Enter key.
Roche Diagnostics
556 Ordering tests
7
7 In the Sample ID field, type the sample ID and press the
Enter key.
I For STAT samples, the sample ID is used in barcode
mode and in non-barcode mode.
8 If you have manually diluted the sample, select the Pre-

dilution check box.
9
9 From the Sample Cup drop-down list, choose the
container type of the sample.
10
10 If necessary, choose the dilution from the Sample
Volume/Dilution drop-down list.
I This dilution setting refers to the dilution that the
instrument applies, not the manual predilution.
11
11 Select the desired test keys or test profile keys.
displayed with a blue border.
u Related topics
• Loading STAT samples (570)
Checking single registered orders

To check single registered orders quickly, look at the Data
Review submenu.
For a complete overview of registered orders, you print a

requisition list on Print > Workplace > Requisition List.
Roche Diagnostics
Ordering tests 557
r To check single registered orders
1
2
2 Choose the respective sample.
I You can sort the list by clicking the column title. You
can sort by sample sequence number (in non-
barcode mode only), sample ID, comment, and
date/time. You can also search for the sample by
choosing the Search button.
3
3 Check the orders that are registered for this sample.
u Related topics
• Correcting registered orders manually (557)
Correcting registered orders manually

Registered orders can be corrected by the host. In
addition, you can correct registered orders manually.
j m You have printed a requisition list.
Roche Diagnostics
558 Ordering tests
r To correct registered orders

manually
1
2 On the requisition list, find the respective sample and

remember the sample ID or sample sequence number,
respectively.

• In barcode mode, type the sample ID of the
respective sample in the Sample ID field and press
the Enter key.
• In non-barcode mode, type the sample sequence
number of the respective sample in the Sequence
No. field and press the Enter key.
f In the test selection matrix, the registered orders
are highlighted with a blue border.
4
4 To correct registered orders, select or deselect the
desired tests or test profiles.
highlighted with a blue border.

Roche Diagnostics
Working with barcodes

To prevent barcode read errors, you must place barcode
labels correctly on sample tubes. If a barcode read error
still occurs, you can enter the barcode manually.
In this section
Placing barcode labels on sample tubes (559)
Placing barcode labels on sample tubes

When you place barcode labels on sample tubes manually,
you must ensure the correct position and orientation to
prevent barcode read errors.
r To place barcode labels on sample

tubes
1 To ensure the correct orientation, place the barcode

vertically aligned with the sample tube.
A B 2
2 To ensure the correct position, place the barcode in
the blue marked barcode scan zone. Maintain the given
PP
distances to the top and bottom of the sample tube.
PP

PP PP
A 100 mm tube B 75 mm tube
Roche Diagnostics
560 Working with barcodes

non-barcoded samples
Unreadable sample barcodes can be entered manually.
You can also enter a sample ID for individual non-barcoded
samples.
If you enter unreadable sample barcodes manually, you

must be certain about the sample’s identity. For that, you
unload the respective sample and visually inspect the
barcode.
! WARNING
Incorrect results may occur due to sample mismatch
Putting a container with a manually entered sample ID on a
wrong rack position or rack may lead to incorrect results.
r When registering samples manually, make sure to
select the correct sample.
r Check the rack ID and rack position number of the
affected sample.
j m The instrument has issued a “Sample Barcode Reading

Error” alarm.
m Or you want to process a non-barcoded sample in
barcode mode.
r To enter an unreadable sample

barcode or a sample ID for a non-
barcoded sample
1 If no “Sample Barcode Reading Error” alarm was issued,

and you want to process a non-barcoded sample in
barcode mode, go to step 8.
2 Choose the Alarm button.
3
3 Find the “Sample Barcode Reading Error” alarm and
remember the rack ID and rack position that is given in
the alarm code.
5 Wait for the measurement of the other samples on the

rack in question to be completed.
f The rack in question is unloaded automatically.
6 Find the rack and the sample in question with the rack
ID and rack position that you remembered in step 3.
Roche Diagnostics
7 Visually inspect the barcode.

• If you are certain about the sample’s identity,
proceed with step 8.
• If you are doubtful about the sample’s identity, you
must dispose of the sample according to local
regulations.
8
9
9 Choose the Barcode Read Error button.
10
10 Choose the Routine option or STAT option according to
the respective sample.
11 Choose the sample type from the Sample Type drop-

down list.
12 Enter the rack ID and rack position that you intend to

place the sample on.
I This rack can be the same rack that you unloaded
before.
13 Enter the correct sample ID.
15 Choose the OK button. 8 Orders and results

u Related topics
• Loading samples (562)
Roche Diagnostics
562 Loading samples
Loading samples
You load routine samples and STAT samples before
starting analysis. You can also load STAT samples and
additional samples during operation.
In this section
About loading samples (562)
About selecting the right container type and rack
range (565)
About mixing different sample types and container types
on a rack (567)
Loading routine samples (568)
Loading STAT samples (570)
Loading additional samples (572)
About loading samples

When loading samples you must observe the correct
alignment of sample tubes on racks and of barcodes. You
must also observe the correct orientation of racks on rack
trays and of rack trays in the core unit.
! WARNING
Incorrect results may occur due to the use of micro
cups on e 602 modules
When the tip of the sample probe touches the inner wall of
a micro cup, an improper sample aspiration may result.
r Do not use micro cups for samples to be processed on
e 602 modules.
Roche Diagnostics
Loading samples 563
Correct alignment of sample tubes on a rack Take special care to place sample tubes correctly on the
rack.
A B Correct placement is especially important for 13 mm

sample tubes, which are narrower and more likely to tilt if
incorrectly positioned. If the sample tubes are not in a
correct upright position on the rack, the sample probe may
attempt to sample outside the sample tube. Also, the
sample probe may hit the side of the sample tube, causing
errors and incorrect results.
The sample tube position must be vertically straight for

correct sampling. The vertical position also reduces
possible barcode reading problems.
! WARNING
Incorrect results may occur if tubes are not aligned
vertically
A Incorrect—sample tube B Correct—sample tube
misaligned vertically aligned Incorrect placement of tubes on racks may cause incorrect
pipetting, which may lead to false results.
r Ensure that tubes and cups are always placed vertically
and are inserted fully in the racks.
r Only use tubes specified for the use with the
instrument.
Readability of barcodes
To prevent barcode read errors, it is necessary to place

the barcode labels on the tubes correctly and to align the
tubes into the rack correctly.
You must place the tube with the barcode label facing the
A B B B A side with the open slot. If a tube in a rack with stabilizers is
rotated outside the barcode reading area, the barcode
label cannot be read.
! WARNING
Incorrect results may occur due to misplaced
barcode label
Barcode read errors could potentially go undetected when
a barcode label is attached wrongly.
r Observe the designated scan range. Keep at least
5 millimeter distance between the barcode label and
the top of the sample tube.
r Attach the barcode label upright to the sample tube
(max. 5° inclination). Do not overlap barcode labels.
A Barcode labels in line B Barcode labels out of
line
r Do not use a wet barcode label or a barcode label with
any writing on it.
Roche Diagnostics
564 Loading samples
Handling samples In accordance with Good Laboratory Practice, observe the

following:
• Keep the cover of the core unit closed during routine

laboratory procedures. Keeping the cover closed
A protects samples in this section from being
C contaminated.
• Before placing any rack, ensure the correct position of
all barcode labels to minimize errors during barcode
readings. This check should be part of any pre-routine
process.
• Before placing a rack tray, ensure the correct
orientation of the racks and the rack tray. The narrow
end of the racks C and the rack tray handle A must be
on the right.
• To prevent splashing between samples and carryover,
B D
always move rack trays with great care.
• After loading a rack tray on the input buffer, move the
racks to the front of the tray and ensure there are no
gaps between the individual racks E.
A/E
u Related topics
• Specifications of racks (2024)
• Specifications of barcodes (2038)
A Handle of the rack tray D Input buffer

on the right
B Output buffer E No gaps between the
C Narrow end of the rack racks on the tray
on the right
Roche Diagnostics
Loading samples 565
About selecting the right container type and rack range

You must load samples in containers and racks that are
appropriate for the respective application, i.e., the sample
type and the application settings.
Standard containers Standard containers are primary tubes, cups, and

calibrator/QC vials that comply with the specifications in
this publication.
The instrument recognizes all standard containers except

micro cups by their dimensions. For micro cups, you must
select Micro cup in Workplace > Test Selection or on the
host.
• Choose a rack with a rack ID that is assigned for the

respective sample type on the Standard tab of Utility
> System > Rack Assignment.
• You can mix all types of primary tubes and cups on a
rack. Use separate racks for calibrator/QC vials.
• To mix different sample types on a rack, choose a rack
assigned in the None fields of the Standard tab.
A B C D E F • Do not use micro cups for tests on e 602 modules.
• You can place standard cups or micro cups on 16 mm
A Standard cup D 16 x 100 mm tube tubes (cup on tube) or directly on racks. If you use micro
B 16 x 75 mm tube E Standard cup on 16 x cups on 16 mm tubes (cup on tube), the 16 mm tube
100 mm tube must have an inner diameter of ≤13.0 mm.
C Standard cup on 16 x F Rack with calibrator
u List of standard containers (2031)
75 mm tube vials or QC vials
Non-standard tubes The instrument cannot detect non-standard tubes and

false bottom tubes (FBT) based on their height.
The instrument recognizes non-standard tubes by the rack

ID. You must use racks from the rack ID range assigned for
the respective container type.
Administrators can change the rack assignment in Utility

> System > Rack Assignment.
Roche Diagnostics
566 Loading samples
• The rack must be assigned on the Non-Standard tab of

Utility > System > Rack Assignment.
• You can mix different non-standard tubes on the same
rack.
• The instrument handles all containers on this rack as
non-standard tubes, regardless of their height.
• Cups on non-standard tubes must be assigned as false
bottom tubes.
u List of non-standard tubes (2033)
False bottom tubes The instrument recognizes false bottom tubes by the rack
ID.
• The rack must be assigned on the False Bottom 1 tab of

Utility > System > Rack Assignment.
• The instrument handles all containers on this rack as
false bottom tubes, regardless of their height.
• On the c 701, c 702, and e 801 modules, you can use
3 different types of false bottom tubes.
• On the c 502 and e 602 module, you can only use
1 type of false bottom tubes as specified on the False
Bottom 1 tab.
• You must enter the dimensions of the container.
• You can only use one container type on one rack.
u Related topics
• About mixing different sample types and container
• Rack assignment (670)
Roche Diagnostics
Loading samples 567
About mixing different sample types and container types

on a rack
You can mix different sample types on a single rack if you
observe certain rules. This is called sample consolidation.
Sample consolidation can be useful, for example, if the

instrument is connected with a CLAS. The CLAS can use
the same rack range for pre-processing different sample
types.
To load different sample types on one rack, you must use a

rack whose rack ID is assigned to the sample type None
fields on Utility > System > Rack Assignment.
For each sample, you must select the sample type on the
data manager or LIS and assign a unique sample ID.
The information about the sample type is sent via HL7

protocol as segment SPM-4 to the control unit. If
necessary, the information about the container type
(segment SPM-27) is also sent via HL7 protocol.
Standard tab You can mix different sample types and container types on
one rack with standard containers. Any possible
combination is allowed. The instrument can detect all
types of standard containers except micro cups by their
dimensions. Thus, you do not need to specify the container
type at the data manager or LIS for standard containers.
However, if you use cups, you must specify the cup type
(Normal or Micro cup) at the data manager or LIS.
If you use non-standard or false bottom tubes on a rack

assigned on the Standard tab, you must specify the
container type in the data manager (False bottom tube 1-3
or Non-Standard Tube 0).
Prerequisites for using all types of sample containers
(including non-standard and false bottom tubes):
1. On the Standard tab, define the rack range for the
sample type None.
2. Specify the container type at the data manager or LIS
(False bottom tube 1–3, Non-Standard Tube 0, Normal,
or Micro cup) as well as the sample type.
3. If you use different false bottom tubes also define their
dimensions on the corresponding False Bottom tabs
without assigning a separate rack range.
Roche Diagnostics
568 Loading samples
Non-Standard tab and False Bottom tabs To mix different sample types on a rack with only non-
standard tubes or false bottom tubes, choose the sample
type None for the rack range definition.
You do not need to specify the container type on the data

manager but you must use the container according to the
dimensions set in the Rack Assignment dialog box.
u Related topics
• About selecting the right container type and rack
range (565)
• Rack assignment (670)
Loading routine samples

You load routine samples before starting analysis.

u Infectious samples
u Infectious waste
u Contaminated samples
u Incorrect results may occur due to interruption of
operation
d m Sample racks
m Rack trays
j m You have prepared sample racks with the correct rack

ID ranges according to the sample types.
m You have printed a requisition list.
u To assign a rack number range to a sample type, see

Rack assignment (670)
u Specifications of racks (2024)
r To load routine samples
1
1 Place the samples into the racks.
2 If you do not use automatic tube rotation and rack

without stabilizers, make sure that the sample barcodes
are facing the open slot in the rack.
Roche Diagnostics
Loading samples 569
3
3 Place the racks on the rack trays.
4
4 Make sure that the green status indicators are on.
I If necessary, wait for the core unit to process rack
trays that have already been loaded. The green
status indicator will turn on after the other rack
trays have been processed.
5
5 Load the prepared rack trays and make sure that the
racks have the correct orientation.
I The narrow end of the racks and the handle of the
rack tray must be on the right.
6
6 Move the racks to the front of the tray and ensure there
are no gaps between the individual racks.
f If the instrument is in Operation mode, it processes
the samples without any further action.
7 If the instrument is not already in Operation mode, start

analysis.
u Related topics
range (565)
• Starting analysis (574)
Roche Diagnostics
570 Loading samples
Loading STAT samples

You load samples from emergency patients as STAT
samples. STAT samples are processed more quickly
between routine samples.
! WARNING
Incorrect results may occur due to sample mismatch
when operating STAT samples in non-barcode mode
r Only load STAT racks into the STAT port when you
operate in non-barcode mode. Observe the requisition
list provided by the instrument.
r Do not insert any sample rack into the STAT port
because the predefined sequence of samples would
get disrupted.
NOTICE
Instrument damage due to improperly oriented
racks in the STAT port
The instrument normally issues an alarm if a rack has been
inserted wrongly in the STAT port. However, under certain
circumstances a wrong rack direction cannot be detected,
which may lead to instrument damage.
r Ensure the correct orientation of the rack when loading
it into the STAT port.
The STAT racks without stabilizers have a rack range

overlapping with the rack range of the red standard STAT
racks. Therefore, either STAT racks without stabilizers or
standard STAT racks can be used in the same rack range.

u Infectious waste
operation
d m Red STAT rack
Roche Diagnostics
Loading samples 571
j m All test selections have been made on the host.

m Or you have made all test selections manually on the
control unit.
r To load STAT samples
1
1 Place the samples into the rack.

3
3 Load the rack into the STAT port and make sure that
the rack is in correct orientation. The barcodes must be
facing to the right.

analysis.
u Related topics
Roche Diagnostics
572 Loading samples
Loading additional samples

You can load additional samples at any time.

u Infectious waste
operation
d m Sample racks or pink rerun racks

m Rack trays
j m All test selections have been made on the host.

m You have prepared sample racks with the correct rack
ID ranges according to the sample types.
m You have assigned samples to pink rerun racks.
u Assigning a sample to a rerun rack in non-barcode
mode (595)
r To load additional samples
1
1 Place the additional samples into the racks.

3
3 If you want to load additional samples at the STAT port,
do the following:
• Load the rack into the STAT port and make sure that
the rack is in correct orientation. The barcodes must
be facing to the right.
• If the instrument is in Operation mode, it processes
I All racks loaded via the STAT port are processed
with STAT priority. STAT racks loaded via rack tray
have second priority.
Roche Diagnostics
Loading samples 573
4
4 If you want to load additional samples into the input
buffer, do the following:
• Place the racks on the rack trays.
• Make sure that the green status indicators are on.
• Load the prepared rack trays and make sure that
the racks have the correct orientation.
5
5 Move the racks to the front of the tray and ensure there
are no gaps between the individual racks.

analysis.
u Related topics
Roche Diagnostics
574 Processing samples
Processing samples
After ordering and loading samples, samples are
processed.
In this section
Starting analysis (574)
Tracking samples (575)
Changing the priority of sample racks (576)
Masking tests (577)
Starting analysis
To begin processing samples, you start analysis.

u Infectious waste
u Moving parts
operation
j m Orders have been downloaded from the host, or you

have ordered samples manually.
m You have loaded samples.
u Ordering tests (550)
Loading samples (562)
r To start analysis
1 Choose the Start button.
2
2 In non-barcode mode only, if you have sorted the
samples on the racks by sample type, enter the first
sample sequence number for each sample type.
I If you have not sorted the samples on the rack by
sample type, the sequence number range can be
identical for all sample types.
Roche Diagnostics
Processing samples 575
3
3 Verify the settings.
I These settings are configuration settings that you
can change from analysis to analysis.
u Related topics
• Using the Start Up Pipe function (791)
• Processing automatic rerun (597)
• Time To Unload window (c 702 module) (1479)
• Rack Reception Mode window (1480)
• CLAS Connection window (1481)
• Defining settings for rack delivery (691)
Tracking samples
The Sample Tracking dialog box provides an overview of the
samples in the output buffer. The search function allows
you to search for samples on the instrument including the
samples that are already in the output buffer.
You use this function to find a sample on its rack. To find a

sample in the database and access its orders and results,
use the Search Sample dialog box.
u About the Search Sample dialog box (585)
r To track a sample
1
1 On the Overview menu, choose the Sample Tracking
button.
2
2 In the Sample Search area, choose the Stat option or
the Routine option, depending on the type of sample or
rack that you want to search for.
3 In the S. Type drop-down list, choose the correct

sample type of the sample or rack that you want to
search for.
Roche Diagnostics
4 Choose from the following search options:

4
• To search by sample ID in barcode mode, select the
S. ID check box and enter the sample ID in the S. ID
field.
• To search by sample sequence number in non-
barcode mode, select the Seq. No. check box and
enter the sample sequence number in the Seq. No.
field.
• To search by rack ID, select the Rack No. check box
and enter the rack ID in the Rack No. field.
I You can combine a search for either a sample ID or a
sample sequence number with a search for a rack
ID.
In all cases, the selected STAT or Routine priority
and the chosen sample type must correspond to the
parameters that you search for. Otherwise, the
search fails.
Also, the location of a sample is indicated only until
the sample is removed from the output buffer.
5 Choose the Search button.

f The search result is highlighted in the Rack Monitor
area and in the Rack Information area.
Changing the priority of sample racks

For urgently needed results, you can increase the priority
of individual sample racks or rerun racks.
The samples on the selected racks are processed with

STAT priority. The rack type remains unchanged.
j m The system is in Operation mode or Rack Reception

mode.
m The respective rack is a sample rack or rerun rack, not a

STAT rack, calibrator rack, or QC rack.
m The respective rack has been loaded via the input
buffer, not via the STAT port.
Roche Diagnostics
r To change the priority of a sample

rack

1
2 Choose the sample you want to be treated as a STAT

sample.
3 Choose the Change Priority button.

3
4
f On the Data Review submenu, the samples on the
prioritized rack are highlighted in red.
Masking tests 8 Orders and results

To optimize your laboratory workflow, you can mask tests,
for example, at times with reduced throughput.
In this section
Masking tests for every measurement (578)
Masking tests for sample measurement (579)
Unmasking tests (580)
Roche Diagnostics
Masking tests for every measurement

To save calibrators, QC material, and time, you can mask
specific tests, for example, at times with reduced
throughput like evenings and weekends. The masked tests
are excluded from the current analysis.
Tests can be masked completely or just for specific

modules and measuring channels.

m Or, in Operation mode: The samples to which you want
to apply this setting have not been loaded yet.
r To mask tests for every measurement
2
2 Choose the Masking button.
3
3 To mask a test on all modules, do the following:
• In the Test column, choose the test.
• To switch to test masking, choose the test
repeatedly until T.Mask is displayed in each
corresponding table cell.
4
4 To mask a test on a specific module or measuring
channel, do the following:
• Choose the table cell corresponding to the test and
the module or measuring channel.
• To switch to test masking, choose the
corresponding table cell repeatedly until T.Mask is
displayed.
5 For e 801 and e 602 modules: Use the Mask on

scheduling within module check box to define whether a
measuring cell (MC) is masked immediately or after the
already scheduled tests have been processed.
Roche Diagnostics
Masking tests for sample measurement

To save time, you can patient-mask specific tests, for
example, at times with reduced throughput like evenings
and weekends. The patient masked tests are excluded
from the current analysis. Calibration and QC
measurement continues.
Tests can be masked completely or just for specific

modules and measuring channels.
The masked tests are displayed as masked (M) in Workplace

> Data Review > Test Review.

m Or, in Operation mode: The samples to which you want
to apply this setting have not been loaded yet.
r To work with patient masking
2
3
3 To mask a test on all modules, do the following:
• To switch to patient masking, choose the test
repeatedly until P.Mask is displayed in each table
cell corresponding to the test.
4
4 To mask a test on a specific module or measuring
• To switch to patient masking, choose the
corresponding table cell repeatedly until P.Mask is
displayed.
Roche Diagnostics
5 For e 801 and e 602 modules: Use the Mask on

scheduling within module check box to define whether a
measuring cell (MC) is masked immediately or after the
already scheduled tests have been processed.
Unmasking tests
To continue measuring tests that were excluded from
analysis, you must remove the test masking or patient
masking.
r To remove test masking or patient

masking
2
3
3 To unmask a test on all modules, do the following:
• Choose the test repeatedly until Unmask is
displayed in each table cell corresponding to the
test.
4 To unmask a test on a specific module or measuring

4
• Choose the corresponding table cell repeatedly
until Unmask is displayed.
Roche Diagnostics
Working with sample results 581
Working with sample results

The Workplace > Data Review submenu displays sample
results and offers various ways to manage and work with
samples and sample results.
In this section
About the sample selection list (581)
About the test result list (584)
About the Search Sample dialog box (585)
About the Filter dialog box (587)
About the Test Review dialog box (588)
Deleting samples (591)
Editing a sample result (592)
Deleting a sample result (593)
Displaying archived sample data (593)
About the sample selection list

The sample selection list on the left side of the screen
displays the samples registered by the system. In non-
barcode mode, one more column is displayed than in
barcode mode.
In barcode mode, the sample selection list consists of

8 columns that can be sorted by S. ID (for sample ID),
Comment, and Date/Time. In non-barcode mode, the list
consists of 9 columns (S. No. for sample sequence number
is added), which can be sorted by S. No., S. ID, Comment,
and Date/Time.
Roche Diagnostics
582 Working with sample results
If you choose a sample in the sample selection list on the

left, the results for this sample are displayed in the result
list on the right.
u About the test result list (584)
Most columns are self-explanatory. Columns are only

described where necessary.
DM This column displays whether results have been sent to the

data manager or not.
No symbol Results have not been sent to the data

manager yet.
H Results have been sent to the data

manager.
C. E. This column displays whether a special wash of the sample

probe has been performed before pipetting of the sample
(C.E. = carryover evasion = special wash).
No symbol Sample has not been pipetted yet.

OR: Sample was pipetted only on
e 801/e 602 modules
# Sample has been pipetted on ISE or

cobas c module.
Additional measurements on
e 801/e 602 modules might be affected
by carryover (see following note).
b A special wash on the sample probe has

been performed before the sample was
pipetted on ISE and/or cobas c module.
Roche Diagnostics
q The # in the C. E. column indicates the risk of potential

carryover for additional or rerun requests from this sample
container.
Immunology applications that are sensitive to sample
carryover are defined as high-priority immunology tests
(HPI). If you request HPI for a sample, this sample is
pipetted on the e 801/e 602 module before pipetting on
the ISE or cobas c modules.
Once a sample has been processed on the ISE or a cobas c
module, a # is displayed in the C. E. column. This sample is
masked and cannot be processed for additional or rerun
HPI requests.
o If a # is displayed, always use newly aliquoted samples
to repeat high-priority immunology tests.
o If a sample has already been processed on the ISE or a
cobas c module and the sample is still on board, and if
an HPI has been sent as a reflex test, the HPI will be
masked and not performed because of possible sample
contamination.
St. This column displays the sample status codes.
No character Sample has been successfully

(Complete) processed. All test results are available
without a data alarm.
O (Ordered) Sample has been requested or

registered but not pipetted yet or an
open order exists for this sample.
Examples of reasons for open orders: All
tests requested were masked or an
automatic rerun test was requested due
to a data alarm.
P (Processing) Sample is being processed.
I (Incomplete) A data alarm occurred on processing the

sample, or one or more tests were
masked.
Roche Diagnostics
About the test result list

This list on the right of the screen displays the results for
the sample that is selected in the sample selection list on
the left.
The result list consists of 9 columns. Unlike the sample

selection list, you cannot sort the result list.
If you choose a sample in the sample selection list on the

left, the results for this sample are displayed in the result
list on the right.
u About the sample selection list (581)

C. E. This column displays whether the special wash specified

has been performed before pipetting.
# Special wash required for this test has not been

performed.
Dil. This column displays a symbol for the sample dilution

factor used for the measurement. The pipetting volumes
are defined on Utility > Application > Analyze. The
instrument performs application-specific dilutions
automatically.
The test was measured with normal pipetting volume.

The test was measured with an increased sample

concentration. This symbol applies to photometric tests
only.
The test was measured with a decreased sample

and ISE tests only. For ISE tests, only urine samples can
be run with decreased volume.
The test was measured with a diluted sample. The number

displays the dilution factor selected in the Workplace
> Test Selection submenu.
The symbols for the dilution are displayed on Workplace

> Data Review if the Print Dilution Ratio check box is
selected on Utility > System > Print Settings.
Roche Diagnostics
A. U. This column displays the analytical unit, e.g., A1, A2, A3.
Separated by a dash, for cobas c modules, the reagent disk
is indicated, e.g., A1-A, A2-B. For cobas e modules, the
measuring channel is given, e.g., A3-1, A4-2. For the ISE
module, the measuring area is indicated, e.g., I1, I2.
Rg. St. For QC samples, this column displays which reagent

cassette was used for the QC measurement:
Current Reagent cassette currently in use
- The current reagent cassette has been used

up since the barcode of the QC sample was
read by the core unit. The QC measurement
was performed using the first standby
reagent cassette.
SB1 The first standby reagent cassette after the

currently used reagent cassette
SB2 The second standby reagent cassette
SBn There can be multiple standby reagent

cassettes SB1 to SBn.
About the Search Sample dialog box

You use this function to search for a sample in the
database and access its orders and results.
To find the sample physically on its rack, you use the

sample tracking function.
u Tracking samples (575)
Search button The Search Sample dialog box is displayed in the Data
Review submenu.
You use the Search button to display the Search Sample

dialog box.
Search Sample dialog box The Search Sample dialog box is an overlay on the right-
hand side of the Data Review submenu. This dialog box
allows you to view both the dialog box and the search
results at the same time.
Roche Diagnostics
Barcode mode and non-barcode mode In barcode mode, you can search by sample ID and
comment. In non-barcode mode, you can additionally
search by sample sequence number.
w Search Sample dialog box, left: barcode mode, right: non-barcode mode
Fields and buttons You use the following fields and buttons to perform your
search:
Find In this field, you enter the respective sample

sequence number, sample ID, or comment.
The drop-down list contains sample
sequence numbers, sample IDs, and
comments that you have entered before.
Search Option You select the Match Case check box to

specify capitalized or non-capitalized
letters.
Focus Move You choose the search direction for the

sample selection list on the left side.
Roche Diagnostics
About the Filter dialog box

You use this dialog box to define filter criteria used to filter
the information displayed in the sample selection list.
Filter button You use this button at the top of the Data Review submenu
to display the Filter dialog box.
Filter options You use the check boxes in this dialog box to set your filter
options.
Most of these options are self-explanatory.
The DM Status group box has a check box for the data
manager status. With this DM Sent check box, you can
search for sample results that have already been sent to
the data manager or host, respectively.
In the Arrived Date fields, you specify a date range. The

date format is defined on Utility > System > Display Settings.
In the Arrived Time fields, you specify a time range. The

time format is hh:mm.
q The filters work individually, i.e. the conditions are not

AND-linked.
If you select the Analyzed Unit and Analyzed Test options,
for example, all samples are displayed that have been
processed on this analytical unit. In addition, all samples
are displayed for which this test has been measured.
Roche Diagnostics
On/Off options You use these options at the top of the Data Review
submenu to toggle the filter on and off.
About the Test Review dialog box

You use the Test Review dialog box to review, delete, and
edit test results for samples or to review QC results.
The Test Review dialog box consists of a sample

information area in the upper part, the test result list, and
buttons.
Test result list This list shows all tests of the sample or QC material
selected on Workplace > Data Review. For samples, the list
is divided into 1st Result and Rerun Result.

R.M. This column displays a result message (Reac, NonReac, or

Border).
Reac Positive result of a qualitative test, for

(reactive) example, for an infectious disease
NonReac Negative result of a qualitative test, for

(non-reactive) example, for an infectious disease
Border Result in a gray zone around cutoff value = 1.

(borderline) This means that no determination regarding
reactive or non-reactive results can be
made.
Roche Diagnostics
Dil. This column displays a symbol for the sample dilution

factor used for the measurement. The pipetting volumes
are defined on Utility > Application > Analyze. The
instrument performs application-specific dilutions
automatically.

only.





e 801/e 602 modules

cobas c module.

Roche Diagnostics
q The # in the C. E. column indicates the risk of potential

carryover for additional or rerun requests from this sample
container.
Immunology applications that are sensitive to sample
HPI requests.
contamination.


manager yet.

manager.
St. This column displays the following statuses:
O (Ordered) Test has been requested but not

pipetted yet.
P (Processing) Test is being processed.
No character Test has been successfully processed.

(Complete) QC result was successfully validated by

the data manager.

masked.
QC result violates a QC rule or no QC
rule was assigned on the data manager.
Roche Diagnostics
V (Validation) QC result has been sent to the data

manager, but validation is not completed
yet.
M (Mask Test) Test has been masked due to an

abnormality during processing.
Displayed only on Workplace > Data
Review > Test Review.
Possible reasons: Auto masking due to
failed calibration, reagent cassette is
masked (empty or not on board),
pretreatment or diluent required by
immunology test is not on board, test is
manually masked, measuring channel is
masked, dilution step is selected but
cannot be carried out, hardware
problems.
E (Edited Test) Test result has been manually edited on

Workplace > Data Review > Test Review.
Deleting samples
If necessary, you can delete a whole sample.
r To delete a sample
1
2
2 If you want to delete an individual sample or a number
of samples, do the following:
• Choose an individual sample or a number of
samples.
• Choose the Delete Record button and confirm the
message which is displayed.
3
3 If you want to delete all samples, choose the Delete All
button and confirm the message which is displayed.
Roche Diagnostics
Editing a sample result

If necessary, you can manually edit a sample result.
After editing a sample result, Edited is displayed in the

Alarm column in any result list on the instrument or host, or
in any printed report.
r To edit a sample result
1
2 Choose a sample.
f The test results list on the right displays the most
recent results.
3
3 Choose the Test Review button.
4
4 In the Result field, enter the new result.
f The Update button turns yellow.
5
• To save the changes and overwrite the previous
result, choose the Update button and confirm the

• To reset the original value, choose the Cancel
button.
f If you have chosen the Update button, edited is
displayed in the Alarm column and E in the St.
column.
Roche Diagnostics
Deleting a sample result

If necessary, you can delete individual results from a
sample.
r To delete a sample result
1
2 Choose a sample.
f The test results list on the right displays the most
recent results.
3
3 Choose the Test Review button.
4
4 Choose the test result.
5
5 Choose the Delete Test button and confirm the
Displaying archived sample data

You can use the Data Review submenu to view archived
sample data.
d m DVD with archived sample data in the binary format

(*.mdf format)
Roche Diagnostics
r To display archived sample data
1 Insert the DVD into the DVD drive.
2
3 Choose the Backup View option.
4
4 Choose the button.
f The Open File dialog box is displayed.
5 Choose the disk drive and the desired archive file.

I Data backup files have the file extension *.mdf.

f The archived sample data is displayed in the Data
Review submenu.
u Related topics
• Performing data backup and archiving (610)
Roche Diagnostics
Processing rerun tests 595
Processing rerun tests

If a data alarm is attached to a test result, the sample may
have to be measured again in a rerun test.
In this section
Processing manual rerun tests (595)
Processing automatic rerun (597)
Processing manual rerun tests

You can also process rerun tests manually although you
have activated and configured automatic rerun. If you have
not activated and configured automatic rerun, you process
rerun tests only manually.
u About automatic rerun (597)
Also, you may prefer to verify a result by a manual rerun

test sometimes.
About processing manual rerun tests in barcode mode

In barcode-mode, you can request a manual rerun test for
routine and for STAT samples like a normal test request.
u Ordering tests (550)
Assigning a sample to a rerun rack in non-barcode mode

Before you can load a sample for a manual rerun test in
non-barcode mode, you must assign the sample to a rerun
rack.
If the sample has been assigned to a rerun rack before, you
must first delete the old assignment.

d m One pink rerun rack
j m You have deleted the old rerun rack assignment.

u Deleting a rerun rack assignment in non-barcode
mode (596)
Roche Diagnostics
596 Processing rerun tests
r To assign a sample to a rerun rack
1

• In barcode mode, type the desired sample ID in the
Sample ID field and press the Enter key.
• In non-barcode mode, type the desired sample
sequence number in the Sequence No. field.
3 Choose the Rerun Rack Assignment button.
4
4 Make sure that you chose the correct sample by
checking the sample ID or sample sequence number.
5 Enter the rack ID and rack position of the pink rerun

rack.
u Related topics
• Loading additional samples (572)
Deleting a rerun rack assignment in non-barcode mode

If the sample was assigned to a rerun rack before, you must
first delete the old assignment before you can assign the
rerun rack again.
r To delete a rerun rack assignment

1

• In barcode mode, type the desired sample ID in the
Sample ID field and press the Enter key.
• In non-barcode mode, type the desired sample
sequence number in the Sequence No. field.
3 Choose the Rerun Rack Assignment button.
Roche Diagnostics
4
4 Choose the Delete button.
f The rerun rack assignment for this sample is
deleted.
5 To close the Rerun Rack Assignment dialog box, choose

the Cancel button.
u Related topics
• Assigning a sample to a rerun rack in non-barcode
mode (595)
Processing automatic rerun

You can use automatic rerun to optimize your laboratory
workflow. You activate automatic rerun both, system-wide
and for each application.
About automatic rerun

You must activate automatic rerun system-wide and for
each application. Then the instrument performs rerun tests
automatically in the same run.
If automatic rerun is activated system-wide and

application-specific, the sample remains on the module
sample buffer until the results of the sample are available.
If a data alarm is attached to a test result, this sample is
automatically measured again in the same run.
Automatic rerun can be performed for most of the data

alarms, except for some alarms according to the rerun test
list.
If the order includes high-priority immunology tests (HPI),
sample special wash applies. To evade sample carryover, a
sample that is measured on a cobas e module does not go
to a cobas c module before the immunology tests are
complete.
u Rerun test list (1228)
The following table shows whether an automatic rerun is

performed or solely requested depending on the system-
wide and application-specific setting:
Roche Diagnostics
598 Processing rerun tests
Automatic rerun settings Rerun test

System-wide activation Application-specific Rerun test is requested Rerun test is performed
configuration
YES YES l l
YES NO l(1) –
NO YES l(1) –
NO NO l(1) –
y Correlation between the system-wide and the application-specific rerun test setting
(1) The sample status changes back to Ordered (O). A rerun test can be performed by restarting the measurement.
If a data alarm is attached to a test result, a rerun test is

requested automatically and irrespective of the system-
wide and application-specific settings.
Only if both settings are activated and configured, a rerun

test is performed automatically in the same run.
Activating automatic rerun system-wide

The system-wide activation of automatic rerun is a
prerequisite for automatic rerun in general.
You can also use this system-wide setting to deactivate

automatic rerun globally without changing each
application-specific setting.
r To activate automatic rerun system-

wide
2
2 In the Automatic Rerun area, choose the Change
button.
3
3 Select the Routine check box and the Stat check box.
5 To close the Start dialog box, choose the Cancel

button.
f The automatic rerun setting is saved, although you
choose the Cancel button.
Roche Diagnostics
Activating automatic rerun for each application

With this application-specific setting for automatic rerun,
you can include and exclude individual applications.
r To activate automatic rerun for each

application
1
1 Choose Utility > Application > Range.
2 Select the test that you want to edit.
3
3 To activate automatic rerun for this application, select
the Automatic Rerun check box.
u Related topics
• Data alarms (1153)
Roche Diagnostics
600 Unloading samples manually
Unloading samples manually

If you must check a routine sample, rerun sample, or STAT
sample visually, you can unload sample racks manually.
Calibrator racks and QC racks cannot be unloaded
manually.
This list describes how the instrument unloads the sample

after you have completed the unloading request:
• If the rack is in a module sample buffer, or in the input
buffer or output buffer, the remaining test orders for
samples on the selected rack are masked (in the St.
column in the Data Review submenu, M is displayed).
• If the rack is in a module, the test orders on this module
are measured. Remaining test orders for other modules
are suspended and are also indicated as masked (in the
St. column in the Data Review submenu, M is displayed).
• The instrument unloads the rack into the output buffer
regardless of the rack supply source.
• When you reload the sample to the instrument, the
masked tests are processed without reordering.
u Top view of the core unit (113)
r To unload samples manually

1
2 Choose a sample.
3 Choose the Unload Rack button and confirm the

3
f In the sample selection list, all samples on the racks
that are to be unloaded are highlighted in blue.
f The racks are unloaded as quickly as possible.
f Remaining test orders for all samples on these racks
are masked.
Roche Diagnostics
About the Calibration Review submenu 601
About the Calibration Review submenu

Use the Workplace > Calib. Review submenu to review the
status of the calibrators used during operation.
The data displayed on this submenu is updated every few

seconds. The data is automatically deleted when the
instrument is powered off.
In this section
About the calibrator selection list (601)
About the test results list (602)
About the calibrator selection list

The calibrator selection list displays the calibrators
registered by the system.
The calibrator selection list is the list on the left.
The list can be sorted by Rack No.-Pos. or by Calibrator.

St. The St. column displays the calibrator status codes:

P (Processing) The instrument has registered the
calibrator (barcode was already read).
At least one calibration is running for the
calibrator.
F (Failed) At least one calibration performed with

this calibrator could not generate a valid
calibration.
S (Successful) Calibrator successfully processed. All

calibrations performed with this
calibrator have generated valid
calibration results.
Roche Diagnostics
602 About the Calibration Review submenu
Buttons You can use the Delete Calibrator button to delete any
calibrator selected in the calibrator selection list.
After powering on the instrument, the Calib. Review

submenu is reset and all data is deleted automatically.
The manual deletion of data with the Delete Calibrator

button and the Delete Test button may be useful after a
change of the calibrator lot or if you need racks for
additional calibrators.
u About the test results list (602)
About the test results list

The test results list on the right side displays details of the
tests performed with the calibrator currently selected in
the list on the left.
Unlike the calibrator selection list, you cannot sort the test
results list.

No character The calibration measurement was not

successfully performed so far.

Calibration might be canceled, for
example, as a result of a sample clot or
not enough sample.

calibrator (barcode was already read)
and at least one calibration is requested
for this calibrator. If the calibrator has
already been pipetted by the module, a
pipetting date and time is available.
F (Failed) No valid calibration has been generated

for the test.
S (Successful) A valid calibration has been generated

for the test.
Roche Diagnostics
About the Calibration Review submenu 603
Buttons You can use the Delete Test button to delete any test of a
calibrator selected in the test result list.
After powering on the instrument, the Calib. Review

submenu is reset and all data is deleted automatically.
The manual deletion of data with the Delete Calibrator

button and the Delete Test button may be useful after a
change of the calibrator lot or if you need racks for
additional calibrators.
u About the calibrator selection list (601)
Roche Diagnostics
604
8 Orders and results About the Calibration Review submenu
Roche Diagnostics
605
Table of contents
After operation 9
At the end of the work shift
In this chapter 9
Performing manual finalization on cobas e modules. . 607
Performing data backup and archiving . . . . . . . . . . . . . 610
About data backup and archiving . . . . . . . . . . . . . . 610
Archiving test results. . . . . . . . . . . . . . . . . . . . . . . . . 611
About archiving output formats. . . . . . . . . . . . . 612
Archiving test results. . . . . . . . . . . . . . . . . . . . . . 612
Archiving and deleting reports. . . . . . . . . . . . . . . . . 614
Archiving reports . . . . . . . . . . . . . . . . . . . . . . . . . 614
Deleting reports . . . . . . . . . . . . . . . . . . . . . . . . . . 616
Saving system parameters . . . . . . . . . . . . . . . . . . . . 617
Restoring system parameters . . . . . . . . . . . . . . . . . 618
List of compatible DVD media . . . . . . . . . . . . . . . . . 619
Formatting DVDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 620
Preparing the instrument for powering off . . . . . . . . . . 622
Powering off the instrument . . . . . . . . . . . . . . . . . . . . . . 623
Powering off automatically. . . . . . . . . . . . . . . . . . . . 624
9 After operation
Powering off automatically with the wash rack . . . 625

Powering off e 801 modules for 64 hours to
17 days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 628
17 days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 632
Powering off manually. . . . . . . . . . . . . . . . . . . . . . . . 636
Roche Diagnostics
606
Table of contents
9 After operation
Roche Diagnostics
Performing manual finalization on cobas e modules 607
Performing manual finalization on cobas e

modules
If a run was interrupted or if finalization did not complete
and the instrument stands unused for several hours, you
must perform finalization manually.
Usually, finalization is performed automatically after

completion of measurement. The Post Operation mode is
displayed during finalization.
Always start a finalization in combination with the

maintenance actions reagent prime and reagent capping.
Never perform finalization alone.
We recommend performing finalization within a

maintenance pipe.

u Infectious waste
u Moving parts
j m The respective modules are masked and in Standby

mode.
r To perform a reagent prime
1
2 Choose the (8) Reagent Prime option. 9 After operation
3
Roche Diagnostics
608 Performing manual finalization on cobas e modules
4
4 Select the desired cobas e modules.
5
5 In the desired Prime Item drop-down list, choose the
Reagent option.
6 In the desired Cycles field, enter “1” cycles.

f The instrument returns to Standby mode.
r To perform finalization
1
2 Choose the (31) Finalization option.
3
4
4 Select the desired cobas e modules.
9 After operation
5
5 In the desired Channel drop-down list, choose the
Ch 1,2 option.

f The instrument returns to Standby mode.
Roche Diagnostics
Performing manual finalization on cobas e modules 609
r To perform reagent capping (e 602

module)
1
2 Choose the (34) Reagent Capping option.
3
4
4 Select the desired e 602 modules.
9 After operation
Roche Diagnostics
610 Performing data backup and archiving
Performing data backup and archiving

To protect data from accidental loss and to comply with
regulatory requirements for long-term retention, you must
store system data.
q Back up your data (test results and system

parameters) at regular intervals.
In this section
About data backup and archiving (610)
Archiving and deleting reports (614)
Saving system parameters (617)
Restoring system parameters (618)
List of compatible DVD media (619)
Formatting DVDs (620)
About data backup and archiving

The system software works with different data types
requiring different storage routines.
Some data is stored by backup, some by archiving:

• A backup allows the system to recover deleted or
destroyed data.
• Archiving data provides access to data for a long time.
Some data types are stored on the data manager, some on

an external storage medium, for example, DVD.
To minimize the risk of data loss, the system software

provides the following storage routines:
• Test results: Archiving all patient data on the data
9 After operation
manager and/or the host.

Additionally, you can make backup copies on an
external storage medium, e.g., DVD.
• Essential information upload: Performing a backup
regularly in a maintenance pipe to store relevant data
on the hard disk of the data manager.
• Reports: Archiving reports on an external storage
medium, e.g., DVD.
• System parameters: Performing a backup to store
system parameters, for example, application
parameters, on an external storage medium, e.g., DVD.
Roche Diagnostics
Performing data backup and archiving 611
Data backup and archiving
Test results Essential information upload Reports System parameters

Control unit
Archiving Backup Archiving Backup
Automatically by daily
Upload
Optional Optional After (re-)programming

maintenance pipe
External storage device External storage device External storage device
Archiving by TraceDoc
Data manager
Weekly by default
External storage device Hard disk
w System storage routines
u For more information about TraceDoc, refer to the

Operator‘s Manual of the data manager.
u Related topics
• Archiving test results (611)
• Archiving reports (614)
• List of maintenance checks (807)
• Saving system parameters (617)
9 After operation
Archiving test results

You can archive the test results of the samples for short
term or long term.
In this section
About archiving output formats (612)
Roche Diagnostics
About archiving output formats

The output format for archiving depends on the target
system you want to view the data on.
Binary archive The data is archived in binary format. This format can only
be restored to the instrument. Other PC systems cannot
read this format. On the screen of the control unit, you
choose this output format with the Data Backup option.
Long-term archive Comma-separated values (CSV) are a standardized format.

This format is suitable for long-term archiving. Other PC
systems can also read this format. However, this format
cannot be restored to the instrument. On the screen of the
control unit, you choose this output format with the Results
(CSV) or Reaction Data (CSV) option.
Archiving test results

After operation, you must archive the test results of the
samples on a storage medium, for example, a DVD.
d m Formatted DVD

u Formatting DVDs (620)
r To archive test results
1
2 Choose an individual sample or a number of samples.

9 After operation
3
3 Choose the Backup Data button.
Roche Diagnostics
4
4 Choose the output format.
5
5 Into the DVD drive of the control unit, insert a formatted
and ready for use DVD.
f The access lamp at the DVD drive starts blinking.
A DVD drive of the control unit
6
6 Choose the button.
f The Save As window opens.
7 Choose the disk drive and folder, enter a file name, and
choose the Save button.
8 Wait for the access lamp to stop blinking.
10 Wait for the archiving to finish.

9 After operation
11 To guarantee a secure backup, remove the DVD from

the DVD drive before shutting down the instrument.
u Related topics
• About archiving output formats (612)
Roche Diagnostics
Archiving and deleting reports

After operation, you must decide which reports you want to
archive and which can be deleted.
By default, reports remain available after power-off.

To minimize the data volume on the instrument, you must
regularly archive reports that may be reused later and
delete unused reports.
In this section
Archiving reports (614)
Deleting reports (616)
Archiving reports
To archive reports, you make backup copies on an external
storage medium, for example, DVD. You must format the
DVD before use.
d m Formatted DVD

u Formatting DVDs (620)
r To archive reports
2
2 Choose the History menu.
9 After operation
Roche Diagnostics
3
3 Into the DVD drive of the control unit, insert a formatted
and ready for use DVD.
f The access lamp at the DVD drive starts blinking.
4
4 From the left list, choose the reports to be archived.
5 Wait for the access lamp to turn off.
6
6 Choose the Backup button.
7 To guarantee a secure backup, remove the DVD from

the DVD drive before shutting down the instrument.
9 After operation
Roche Diagnostics
Deleting reports
You can delete reports manually or configure the
instrument so that the reports are deleted automatically at
shutdown.
If you want the instrument to delete the reports

automatically, you must select the Data Initialization check
box in Utility > System > Print Settings.
r To delete reports manually
2
2 Choose the History menu.
3
3 If you want to delete selected reports from the list, do
the following:
• Choose the reports to be deleted.
• Choose the Delete button.
4
4 If you want to delete all reports from the list, choose
the Delete All button.
9 After operation
u Related topics
• Formatting DVDs (620)
Roche Diagnostics
Saving system parameters

Use the following procedure to make a backup of system
parameters on a storage medium (DVD).
The following system parameters are written using the

Parameter Write option:
• Special wash settings
• System settings
• Data manager communication settings
• Maintenance pipe settings
• Profile settings
• Utility reagent settings
• Start settings
• Key settings
• Channel assignment parameters
• Calculated and compensated test settings
• Alarm settings
• Comment settings
• Operator ID setting parameters
• Barcode check digit settings
• Power up pipe settings
• Scale settings for each graph
• Data manager settings
• Pre-analytical system settings
• Module settings
q Restoring the system parameters:

The system parameters can only be restored to the same
instrument. Use the Parameter Read option in the
Parameter Read/Write window.
u Restoring system parameters (618) 9 After operation
Roche Diagnostics
r To save system parameters on a

storage medium
1 Insert an appropriate storage medium into the disk

drive.
2
3 Choose the (14) Parameter Read/Write option.
4
5
5 Choose the Parameter Write option.

f The parameters are saved to the storage medium.
7 When processing is complete, remove the storage

medium from the disk drive.
Restoring system parameters

Use the following procedure to restore system parameters
from a storage medium. The system parameters can only
be restored to the same instrument.
9 After operation
r To restore system parameters to the

system
1
2 Choose the (14) Parameter Read/Write option.
Roche Diagnostics
3
4 Insert an appropriate storage medium into the disk

drive.
5
5 Choose the Parameter Read option.
7 To start loading the data, choose the Yes button.
List of compatible DVD media

The control unit is equipped with a DVD drive. The DVD
drive can be used for installing software updates, archiving
data, and restoring data.
DVD media types
Media type Explanation When to use

DVD+R Each burn is permanent. You cannot If you perform subsequent backups
(recordable media) reformat and rewrite R media. When using without removing the DVD from the
packet writing, you can delete files. control unit, R media can be used.
However, deletion does not free up
storage space (the storage space
becomes inaccessible instead).
DVD-RW, DVD+RW You can delete unwanted files from If you want to use a DVD on other
(rewritable media) RW media to free up storage space. computers and then add backups at the
control unit, RW media are required.
DVD-RAM DVD-RAMs have the same features as If you want to use a DVD on other
(random-access memory media) DVD+RWs and DVD-RWs, but have some computers and then add backups at the
advantages for data backups: High control unit, RAM media are an option. If
reliability, disc defect management, long you need high and long reliability,
life, and they can be rewritten over RAM media are required.
100 000 times. Note: DVD-RAMs can only be read in DVD-
RAM drives.
9 After operation
y DVD media types compatible with the instrument
Roche Diagnostics
Formatting DVDs
All DVD media must be formatted with UDF (Universal Disc
Format) Version 2.0 before use.
You can format DVD+RW, DVD-RW, and DVD-RAM media

several times. DVD+R media can only be formatted once.
You must use the control unit for formatting. The control
unit may not be able to read a DVD formatted on other
computers.
q Formatting deletes all data on the medium.

Before formatting, make sure that no important data is
stored on the DVD.
d m DVD
r To format a DVD
1
1 Insert the DVD into the DVD drive of the control unit.
2 Wait for the access lamp at the DVD drive to turn off.
A
9 After operation
3
3 To display the Format (Option) menu, press Ctrl+F7.
4 Choose the Quick Format option.

I Depending on the media type, only the Full option is
available.

f The DVD is formatted. Formatting may take several
minutes.
Roche Diagnostics
6 Wait until the dialog box disappears.

f The DVD is ready for archiving.
q It is not necessary to make the DVD compatible

with other computers. The DVD is automatically
compatible with other computers when you remove it
from the DVD drive of the control unit.
The DVD might not be readable on operating systems
previous to Windows 7.
u Related topics
• Performing data backup and archiving (610)
9 After operation
Roche Diagnostics
622 Preparing the instrument for powering off
Preparing the instrument for powering off

To ensure proper performance of the instrument and to
minimize the risk of data loss, you must prepare the
instrument for powering off.
r To prepare the instrument for

powering off
1
1 If there are still racks placed in the output buffer,
remove the racks while the status indicators are on.
2 Dispose of samples according to local regulations.
A Status indicators
3
3 On the c 502 module, make sure that all reagent
cassettes are removed from the disposal port.
4 Dispose of reagent cassettes according to local

regulations.
5 If you have not performed scheduled maintenance

(e.g., daily, weekly) at the beginning of the work shift,
perform scheduled maintenance now.
9 After operation
6 If you have defined a maintenance pipe for the next

day, make sure that sufficient amounts of the required
reagents are on board:
A I For the c 702 module at least 15 mL ECO-D. For the
c 502 module at least 8 mL ECO-D.
A Disposal port for reagent cassettes (c 502 module)
u Related topics
• Performing daily maintenance (285)
Roche Diagnostics
Powering off the instrument 623
Powering off the instrument

After routine operation is finished and after preparing the
instrument for powering off, you can power off the
instrument.
Power-off Extended power-off

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Automatic and manual power-off You can power off the instrument automatically or
manually.
You can power off the instrument manually using the OFF
button. You can also create a maintenance pipe that
powers off the instrument automatically.
9 After operation
If your instrument contains cobas e modules that are not

used for more than 64 hours, you must power-off the entire
instrument following the corresponding procedure.
Powered off When the instrument is powered off, the analytical

modules and the control unit are disconnected. However,
power for cooling reagents and auto QC materials is still
supplied.
Roche Diagnostics
624 Powering off the instrument
Automatic power-up The time switch at the front panel of the core unit allows
you to power up the instrument at a set time each day. The
instrument can then perform a maintenance pipe with the
Power Up Pipe function.
This way, the instrument can perform initialization and

maintenance actions during your absence before the
beginning of a work shift. By the time you arrive, the
instrument is ready for operation.
u Using the Power Up Pipe function (789)
u Powering on the instrument automatically (262)
In this section
Powering off automatically (624)
Powering off automatically with the wash rack (625)
Powering off e 801 modules for 64 hours to 17 days (628)
Powering off e 602 modules for 64 hours to 17 days (632)
Powering off manually (636)
Powering off automatically

You can power off the instrument using a maintenance pipe
with the Power Off check box selected.
To use this powering off procedure, you must create an

appropriate maintenance pipe and group the maintenance
pipe into a maintenance type first.
u Creating a maintenance type (795)
r To power off automatically

9 After operation
1
2 Select the power-off pipe.
3

f After the maintenance pipe is performed, the
Roche Diagnostics
Powering off automatically with the wash rack

If your instrument contains ISE or cobas c modules, you
must process the wash rack each day. You can power off
the entire instrument automatically and process the wash
rack in a maintenance pipe.
Processing the wash rack is a combined maintenance

action for the ISE module and the cobas c modules. The
inner wall of the sample probe and the liquid waste flow
path are cleaned as well as the ISE flow path, the ISE
dilution vessel, and the electrodes. After cleaning, the
electrodes are reconditioned with Activator.
Ways of processing the wash rack We recommend processing the wash rack within a
maintenance pipe with the Power Off check box selected.
This way, you save time at the end of a day because the
instrument is powered off automatically after the
completion of the maintenance pipe.
If the instrument is operated continuously for more than

8 hours a day, you can also process the wash rack during
operation.
operation (899)
Required reagent volumes on You must place system reagents on the wash rack as
the wash rack follows. The number of wash cycles must be set by a
system administrator in Utility > System > Wash Racks.
Rack position System reagent Wash cycles ISE c 701, c 702 c 502 module
modules
(2 units) (per module)
1 SmpCln1 5 600 µL 225 µL
2 SysClean 15 600 µL – –
3 Activator 15 600 µL – –
y Required reagent volumes
9 After operation
Only 300 µL are required for an ISE module with one

measuring unit.
You must take into account the dead volume of the used
containers.
Example: c 701–c 502–c 502 module combination:
600 µL + 450 µL SmpCln1 = 1050 µL + 100 µL (dead
volume of standard cup).
Minimum volume = 1150 µL.
Roche Diagnostics

u Infectious waste
u Moving parts
c • At the end of a work shift each day

• At least once every 24 hours
n • Operator time: approximately 3 minutes

• System time: approximately 21 minutes
d m SmpCln1 (only required for c 502, c 701, and c 702

modules)
m SysClean solution
m Activator
m NaOHD reagent cassettes on both reagent disks of the
c 701 and c 702 modules (D1, approx. 7.6 mL)
m ISE Internal Standard, approx. 54 mL
m ISE Diluent, approx. 20 mL
m ISE Reference Electrolyte, approx. 17 mL

m A maintenance pipe for the wash rack is configured.
r To prepare the wash rack
1
1 Place sample tubes or cups into positions 1–3 on a
wash rack.
A
2 Pipette suitable amounts of the prescribed system
B
reagents into the sample tubes.
C I Take into account the dead volume of the used
9 After operation
containers.
3 Make sure that the sample tubes or cups are positioned

as instructed.
I If the sample tubes or cups are not positioned
correctly, no sampling or washing will be performed.
A Position 1: SmpCln1 C Position 3: Activator

B Position 2: SysClean
Roche Diagnostics
r To start the wash rack maintenance

pipe
1
1 Make sure that the green status indicators of the input
buffer are on.
A Green status indicators of the input buffer
2
2 Place a rack tray with the wash rack into the input
buffer.
I Make sure that the wash rack is in the correct
orientation.
3 Close the cover of the input buffer.
4
5 Select the wash rack maintenance pipe.

9 After operation
6

f After the maintenance pipe is performed, the
Roche Diagnostics
8 Do the following:
• Make sure that you calibrate all ISE tests when you
start the instrument again.
• Check the calibration and QC results for ISE before
you load samples with ISE requests.
I After processing the wash rack all ISE tests must be
calibrated. Do not load samples with ISE requests
before you have checked the calibration and QC
results for ISE.
9 If washing is interrupted for some reason, do the

following:
• Perform the maintenance action wash reaction
parts.
• Perform the maintenance action cell blank
measurement.
• For the ISE modules, perform the maintenance
action reagent prime with the All option.
u Related topics
Powering off e 801 modules for 64 hours to 17 days

If you plan not to use the instrument for more than
64 hours, you must prepare the e 801 module for power-
off by performing specific maintenance actions. If you plan
not to use the system for more than 17 days, contact your
To perform all maintenance actions with their specific

options, you can group the maintenance actions in a
maintenance pipe and start the maintenance pipe.
The maintenance pipe for extended power-off must

contain the following maintenance actions:
9 After operation
Maintenance action Cycles Module

(8) Reagent Prime Reagent option e 801, e 602
5 cycles
5 cycles
(32) Empty PC/CC Reservoir - e 602
(23) Sipper Air Purge 10 cycles e 801, e 602
y Recommended maintenance actions for extended power-off
Roche Diagnostics
Even when the instrument is powered off, the reagent

storage is cooled on the e 801 module. If you plan to
disconnect the power cable or to turn off the circuit
breaker at a module, you must unload the reagent
cassettes from the corresponding module.
n Approximately 30 minutes

m A maintenance pipe for extended power-off is
configured.
m All daily, every 2 weeks, and other required
maintenance actions are performed.
m There is no media in the DVD drive.
r To perform the extended power-off

pipe
1
2 Select the extended power-off pipe.
r To remove liquid from the flow path

of the measuring cell and remove
consumables
1
1 Perform (25) MC Exchange.
• Choose Utility > Maintenance > Maintenance.
9 After operation
• Choose the (25) MC Exchange option.

• Choose the Select button.
• Select the e 801 modules.
• Choose the Ch 1,2 option.
• Enter “1” cycle.
Roche Diagnostics
2
transparent door.
3 Remove all magazines from the magazine lifter and

store them dust free.
4 Close the transparent door.
5
5 If the status indicator on the magazine drawer is on,
fully open the magazine drawer of the e 801 module.
6 From the magazine waste compartment, remove all

empty magazines.

regulations.
9 After operation
Roche Diagnostics
r To power off the instrument and turn

off the external water supply
1
1 To power off the instrument, press the power-off
button.
• The instrument is switched off, except for the
reagent cooling unit. Shortly afterwards the control
unit will shut down.
I Before you begin, ensure that you know your user
name and password for the data manager and the
control unit.
A Power-off button
2
2 When the system is powered off, turn off the external
water supply.
9 After operation
3
3 If necessary, turn off the timer toggle switch.
u Related topics
• Powering off a specific module completely (1235)
Roche Diagnostics
Powering off e 602 modules for 64 hours to 17 days

If you plan not to use the instrument for more than
64 hours, you must prepare the e 602 module for power-
off by performing specific maintenance actions. If you plan
not to use the system for more than 17 days, contact your
To perform all maintenance actions with their specific

options, you can group the maintenance actions in a
maintenance pipe and start the maintenance pipe.
The maintenance pipe for extended power-off must

contain the following maintenance actions:

5 cycles
5 cycles

u Infectious waste
u Moving parts

m A maintenance pipe for extended power-off is
9 After operation
configured.
m All daily, weekly, and other required maintenance
actions are performed.
m There is no media in the DVD drive.
Roche Diagnostics
r To perform the extended power-off

pipe
1
2 Select the extended power-off pipe.
r To remove liquid from the flow path

of the measuring cell and remove
consumables
1
1 Perform (25) MC Exchange.
• Choose the (25) MC Exchange option.
• Select the e 602 modules.
• Choose the Ch 1,2 option.
• Enter “1” cycle.
2
transparent door.
3 Remove all magazines from the magazine lifter and

store them dust free.
4 Close the transparent door.
5 If the status indicator on the magazine drawer is on,

fully open the magazine drawer of the e 602 module.
6 From the magazine waste compartment, remove all

empty magazines.
A B
9 After operation

A Magazine lifter B Magazine waste
regulations.
compartment
8 Close the magazine drawer of the e 602 module.
Roche Diagnostics
r To remove reagents
1
1 Remove all reagent cassettes from the reagent disk of
e 602 modules.
2 Fully close all reagent cassettes.

2
3 Refrigerate the reagent cassettes.

I You can use the reagent cassettes again.
A B C

B Open
9 After operation
Roche Diagnostics
r To power off the instrument and turn

off the external water supply
1
button.
control unit.
A Power-off button
2
2 When the system is powered off, turn off the external
water supply.
9 After operation
3
3 If necessary, turn off the timer toggle switch.
u Related topics
• Powering off a specific module completely (1235)
Roche Diagnostics
Powering off manually

Use this power-off procedure if the instrument is not used
for 64 hours or less (for example, a weekend).
During power-off, the reagent storages continue to be

cooled.
c We recommend powering off the instrument at least once a

week. Start it up again afterwards.
r To power off the instrument manually

for 64 hours or less
1
button.
control unit.
A Power-off button
9 After operation
2
2 If you start the instrument manually at the beginning of
the next work shift, turn off the external water supply.
Roche Diagnostics
637
Table of contents
Special operation 10
In this chapter 10
Overview of masking functions . . . . . . . . . . . . . . . . . . . 639
Operating with a pre-analytical system . . . . . . . . . . . . 641
About connecting a pre-analytical system. . . . . . . 641
Processing samples with a pre-analytical system . 643
Operating the instrument in backup operating mode . 644
Activating backup operating mode . . . . . . . . . . . . . 644
Measuring samples in backup operating mode . . . 646
Deactivating backup operating mode . . . . . . . . . . . 649
10 Special operation
Roche Diagnostics
638
Table of contents
Roche Diagnostics
Overview of masking functions 639
Overview of masking functions

While an element or function is masked, it is excluded from
analysis.
There are manual and automatic masking functions:

• Some masking functions are set automatically by the
instrument, depending on specific conditions.
• You can use manual masking functions to exclude, e.g.,
a specific test or reagent from analysis temporarily.
Automatic masking functions
Masking function Description Unmasking

Masking tests for If Automated Patient masking when QC Error is configured on First, you validate the QC result.
sample the data manager and a QC error has occurred, the system Then, in Start > Masking, you
measurement masks the test. No samples are measured. unmask the patient masking.
(Patient masking) On Workplace > Data Review > Test Review in the St column,
“M” is indicated.
Reagent masking If one of the following conditions is met, the system masks the The test is unmasked automatically
test: as soon as you load a new reagent
o A required reagent is empty and no standby reagent is on cassette or the foam has gone.
board (red alarm).
o A reagent has been open for a long time (e 602 module).
o A reagent is expired (e 801 module).
o A reagent has foam (c 701/c 702/e 602 module).
o An assay or pretreatment reagent cassette could not be
linked to the required partner reagent cassette (link status
Free), or the partner reagent is not on board (e 801/e 602
module).
On Workplace > Test Selection, a red bar is displayed.
On Workplace > Data Review > Test Review in the St column,
Calibration auto- If calibration auto masking is activated and the calibration of a The test is unmasked automatically
masking test has failed or is invalid, the system masks the test. as soon as calibration is performed
On Workplace > Test Selection, a purple bar is displayed. successfully.
On Workplace > Data Review > Test Review in the St column,
y Overview of automatic masking functions 10 Special operation
Roche Diagnostics
640 Overview of masking functions
Manual masking functions
Masking function Description Masking/unmasking

Masking tests for To exclude a specific test from the current analysis, you mask a In Start > Masking, you mask or
every measurement test. No samples are measured, no QC nor calibration is unmask the test.
(Test masking) performed. Test masking is used, for example, at times with
reduced throughput to save calibrators, QC materials, or time.
On Workplace > Test Selection, a yellow dot is displayed.
On Workplace > Data Review > Test Review in the St column, “M”
is indicated.
You can also activate test masking from the data manager.
Masking tests for To exclude a specific test from the current analysis, you mask a In Start > Masking, you mask or
sample test. No samples are measured. Patient masking is used, for unmask the test.
measurement example, to save sample material.
(Patient masking) On Workplace > Data Review > Test Review in the St column, “M”
is indicated.
You can also activate patient masking from the data manager.
Module masking You mask a module if you want to perform one of the following In Start > Masking > Module
actions: Masking, you mask or unmask the
o You want to perform background maintenance on one module.
module while the system is operating.
o You want to load reagents on the masked module (c 701
module, e 602 module, ISE module).
The masked module switches to Standby mode.
If a test cannot be measured since the module is masked, on
Workplace > Data Review > Test Review in the St column, the
status of the test is indicated as “M”.
Reagent cassette If you do not perform a test daily, you can temporarily mask a When in Standby mode or in
masking specific reagent cassette. Operation mode, in the Overview
On Workplace > Test Selection, a red bar is displayed if all menu, you choose the module.
reagent cassettes of a test are masked. For example, if the In the Reagent Overview menu,
current and SB1 cassette are on the system and both are you choose the corresponding
masked, a red bar is displayed. reagent cassette.
If a test with reagent cassette masking has already been To mask the reagent cassette, in
requested, the status of the test is indicated as “M” in the St the Detail dialog box you choose
column on Workplace > Data Review > Test Review. the R. Pack Mask button.
To unmask the reagent cassette,
the system must be in Standby
mode. Then, in the Detail dialog
box you choose the R. Pack
Unmask button.
Masking module Mask parts of a module, i.e., measuring channel, ISE unit, or You unmask the corresponding
parts reagent disk A or B, if you want to perform one of the following part in Start > Masking.
actions:
o You want to print a Precision Check report of the unmasked
module parts.
o You want to troubleshoot on the masked module parts.
On Workplace > Data Review > Test Review in the St column, “M”
is indicated.
y Overview of manual masking functions
u Masking tests for sample measurement (579)

u Removing reagent masking (312)
u Setting calibration auto-masking (495)
u Masking tests for every measurement (578)
u Masking and unmasking reagent cassettes (314)
Roche Diagnostics
Operating with a pre-analytical system 641
Operating with a pre-analytical system

A pre-analytical system takes over time-consuming tasks
prior to testing. Examples for a pre-analytical system are
the MODULAR PRE-ANALYTICS (MPA) or the cobas® 8100
automated workflow series.
In this section
About connecting a pre-analytical system (641)
Processing samples with a pre-analytical system (643)
About connecting a pre-analytical system

The system can be connected to a pre-analytical system.
q If you use a pre-analytical system, you cannot select

Rack Reception mode for the instrument.
w The cobas® 8000 modular analyzer series connected to an MPA
Roche Diagnostics
642 Operating with a pre-analytical system
A pre-analytical system can take over the following pre-

and post-analytic tasks:
• Sorting and centrifuging samples
• Taking aliquot samples for connected instruments
• Taking secondary tubes for other targets
• Printing barcode labels and labeling the sample tubes
• Archiving samples
q Only Roche Service representatives are authorized to

install and configure the connection to a pre-analytical
system.
Clas Connect. button
In Overview > Module Overview, the Clas Connect. button is

displayed if the system is connected to a pre-analytical
system.
The Clas Connect. button displays the status of the

connection to the pre-analytical system:
The connection to the pre-analytical system or the pre-

analytical system itself is in an alarm status higher than
caution level.
The connection to the pre-analytical system or the pre-

analytical system itself is in the alarm status of caution
level.
The connection to the pre-analytical system is online.

The connection to the pre-analytical system is offline.
Sample processing If there is a connection to a pre-analytical system, the

function of the STAT port changes. The STAT port is used
to transport routine samples from the pre-analytical
system to the instrument. STAT samples must be
positioned in red STAT racks and placed into the rack input
buffer of the core unit or to the STAT port of the pre-
analytical system.
Routine samples are transferred from a pre-analytical
system to the instrument memorizing the rack and the rack
position number. They need not be barcoded.
Nevertheless, barcodes optimize the identification of
samples throughout the workflow.
Roche Diagnostics
Operating with a pre-analytical system 643
Processing samples with a pre-analytical system

The pre-analytical system interacts with the host and the
data manager. Therefore, operating with a pre-analytical
system requires a different sample processing than
operating without a pre-analytical system.
r To process samples with a

pre-analytical system
1 At the host, choose the required tests using the sample

ID, rack ID, and rack position number.
2
2 Load routine samples into the pre-analytical system.
3
3 Load STAT samples directly into the rack input buffer of
the core unit or into the STAT port of the pre-analytical
system.

f The control unit requests the selected tests from
the host.
u Related topics 10 Special operation

• About connecting a pre-analytical system (641)
• Loading routine samples (568)
• Loading STAT samples (570)
A
• List of reformatter racks (2029)
A Rack input buffer of the instrument
Roche Diagnostics
644 Operating the instrument in backup operating mode
Operating the instrument in backup

operating mode
If racks cannot be conveyed to the analytical modules, the
Backup Operation mode enables you to continue sample
measurement on the modules.
To process samples in Backup Operation mode, you must

activate the Backup Operation mode.
Backup Operation mode is only possible in barcode mode.
Barcoded routine and STAT samples can be placed

manually in the module sample buffers (MSBs).
Backup operation is possible on all modules at the same

time.
In this section
Activating backup operating mode (644)
Measuring samples in backup operating mode (646)
Deactivating backup operating mode (649)
Activating backup operating mode

Before measuring samples in Backup Operation mode, you
must switch the instrument to Backup Operation mode and
set up the container height used.
j m The instrument must be in barcode mode.

m Barcoded samples
r To activate backup operating mode
1
1 Choose Utility > System > Rack Delivery.
Roche Diagnostics
Operating the instrument in backup operating mode 645
2
2 From the Backup Operation Sample Height drop-down
list, choose the container type to be used.
I You must choose a container type because the
container height cannot be detected in Backup
Operation mode.
4
5
5 Choose the MSB button corresponding to the module
on which you want to process the samples.
6
6 In the Module dialog box, choose the Backup Operation
button.
7
7 Wait for the instrument to switch to Backup Operation
mode.
f The Backup Operation mode is displayed in the
status line.
f The instrument is ready to measure samples.
Roche Diagnostics
Measuring samples in backup operating mode

When operating in Backup Operating mode, you must load
the racks in the backup operation port of the MSB.
To use the backup operation port on the MSB of a c 702

module, you must remove the preparation table at the
MSB.

u Moving parts
operation
A B
A Module sample buffer B Backup operation port

(MSB)
j m Backup Operating mode activated.
r To measure samples in backup

operating mode
1
1 From Workplace > Test Selection or from the data
manager, choose the test.
2 To print a list of samples to be loaded, choose Print

2
> Workplace > Requisition List.
Roche Diagnostics
3
3 Prepare the racks:
• Prepare sample racks for routine samples.
• Prepare red racks for STAT samples.
• Choose the rack ID according to the sample type,
e.g., Ser/Pl, Urine, CSF.
4 With the barcode facing the open slot in the rack, place
barcoded samples into the rack.
A B A C
A Rack number C Red STAT rack

B Gray routine rack
5
5 Check that the green status indicator of the MSB is
lighting.
6
6 Open the backup operation port.
7 WARNING! Incorrect results may occur by racks

inserted the wrong way.
NOTICE! Instrument damage by racks inserted the
wrong way.
7 Load the rack into the backup operation port:
• Observe the direction of the rack.
• Align the rack to the right and the rear side of the
backup operation port.
8 Close the cover of the backup operation port.

A
A Backup operation port
9
Roche Diagnostics
10
on which you process the samples.
11
11 To start measuring, choose the Backup Analyze button.
f After all requested tests have been measured, in
the Module dialog box, the Backup Collect button is
available.
12
12 Before unloading racks from the backup operation port,
check that the green status indicator on the MSB is
flashing.
13
13 To unload racks, choose the Backup Collect button.
14 Unload the racks from the backup operation port.

u Related topics
Roche Diagnostics
Deactivating backup operating mode

After operating in Backup Operating mode, you must
unload the racks and deactivate the Backup Operating
mode.
r To deactivate backup operating mode
1
2
on which you want to stop the Backup Operating mode.
I You can also choose the Stop button to deactivate
the Backup Operating mode. In that case, however,
all functions on all modules are stopped.
3
3 In the Module dialog box, choose the Cancel
Maintenance button.
4
f The module returns to Standby mode.
Roche Diagnostics
650
10 Special operation Operating the instrument in backup operating mode
Roche Diagnostics
651
Table of contents
Configuration 11
In this chapter 11
Overview of configuration. . . . . . . . . . . . . . . . . . . . . . . . 655
Setting the time switch . . . . . . . . . . . . . . . . . . . . . . . . . . 656
Setting the day and time on the time switch . . . . . 657
Setting the start-up time on the time switch . . . . . 659
Setting holidays on the time switch. . . . . . . . . . . . . 662
Checking the programs on the time switch . . . . . . 664
Deleting programs on the time switch . . . . . . . . . . 665
Defining system settings . . . . . . . . . . . . . . . . . . . . . . . . . 667
Creating operator IDs . . . . . . . . . . . . . . . . . . . . . . . . 668
Rack assignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 670
About rack assignment . . . . . . . . . . . . . . . . . . . . 670
About the rack assignment tables. . . . . . . . . . . 672
Assigning sample racks for standard
containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 675
Assigning sample racks for non-standard
tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 676
Assigning sample racks for false bottom tubes 677
Assigning sample racks for Sarstedt micro
tubes on the e 801 module . . . . . . . . . . . . . . . . 679
Assigning calibrator and QC racks to modules 680
Assigning QC racks for automatic QC. . . . . . . . 681
Assigning tests and test profiles to test keys. . . . . 682
Setting the date and time on the instrument . . . . . 687
Activating Rack Reception mode . . . . . . . . . . . . . . . 688
Defining settings for the incubators of cobas c
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 690
Defining settings for rack delivery. . . . . . . . . . . . . . 691
Defining settings for the reagent manager of the
11 Configuration
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 693

Defining settings for the e 801 module . . . . . . . . . 695
About the quick start mode on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 696
About reagent expired masking on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 697
Defining quick start mode and masking of
expired reagents on the e 801 module. . . . . . . 698
About foam detection on the e 801 module . . 699
Defining reagent levels for yellow and purple
reagent alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700
Defining reagent levels for reagent loading on the
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 702
Roche Diagnostics
652
Table of contents
Installing applications . . . . . . . . . . . . . . . . . . . . . . . . . . . 704

Installing new applications (overall presentation) . 704
Downloading and updating application settings . . 710
Downloading new application settings . . . . . . . 710
Downloading application settings for diluents
and detergents for cobas c modules . . . . . . . . 713
About updating application settings. . . . . . . . . 715
List of editable application settings . . . . . . . . . 716
Updating application settings on cobas c
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717
Updating application settings on cobas e
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 719
About development channel applications . . . . . . . 720
About the HbA1c test on the c 502 module . . . . . 721
About result calculation of the HbA1c test . . . . . . 722
Installing the HbA1c test on the c 502 module. . . 723
Installing the serum index application on cobas c
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 728
Defining application settings . . . . . . . . . . . . . . . . . . . . . 731
Configuring analyze parameters . . . . . . . . . . . . . . . 731
Defining dilution factors for cobas e modules. 731
Configuring calibration parameters . . . . . . . . . . . . 733
Configuring automatic calibration. . . . . . . . . . . 733
Defining the duplicate limit for the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 735
Configuring range parameters. . . . . . . . . . . . . . . . . 737
Defining decimal places . . . . . . . . . . . . . . . . . . . 737
Defining automatic rerun tests. . . . . . . . . . . . . . 739
Configuring automatic QC . . . . . . . . . . . . . . . . . 740
About technical limits . . . . . . . . . . . . . . . . . . . . . 743
Defining technical limits for tests on the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 744
Defining the repeat limit . . . . . . . . . . . . . . . . . . . 745
Configuring qualitative result reporting for
cobas c modules . . . . . . . . . . . . . . . . . . . . . . . . . 747
Configuring qualitative evaluation of
quantitative tests for e 602 modules . . . . . . . . 748
About other parameters on cobas c and ISE
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 749
About formula parameters on cobas c, ISE and
11 Configuration
e 602 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 750

Defining special wash data . . . . . . . . . . . . . . . . . . . . . . . 751
Downloading special wash data. . . . . . . . . . . . . . . . 752
Configuring special washes for cobas c modules. 753
Configuring a reagent probe wash for cobas c
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 753
Configuring a reaction cell wash for cobas c
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 755
Configuring a sample probe wash for cobas c
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 757
Configuring a reagent probe wash for the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 759
Deleting special wash data for cobas c modules . 761
Roche Diagnostics
653
Table of contents
Assigning tests to modules. . . . . . . . . . . . . . . . . . . . . . . 762

Assigning tests to the ISE module . . . . . . . . . . . . . . 762
Assigning tests to cobas c modules . . . . . . . . . . . . 763
Assigning tests to cobas e modules . . . . . . . . . . . . 764
11 Configuration
Roche Diagnostics
654
Table of contents
11 Configuration
Roche Diagnostics
Overview of configuration 655
Overview of configuration
Your Roche Service representative has configured the
system according to your specifications. If you are an
administrator and must adjust a setting, follow the
procedures in this chapter.
q If you have any questions, contact your Roche Service

representative.
11 Configuration
Roche Diagnostics
656 Setting the time switch
Setting the time switch

If you want the instrument to start up automatically, you
must set the time switch on the front panel of the core unit.
B C
A Time switch D Mode switch F OUT1 / OUT2 switches

B Timer toggle switch E Day keys G OUT switches
C Lid (open)
To activate the time switch, you must set the timer toggle
switch to ON.
11 Configuration
In this section
Setting the day and time on the time switch (657)
Setting the start-up time on the time switch (659)
Setting holidays on the time switch (662)
Checking the programs on the time switch (664)
Deleting programs on the time switch (665)
u Related topics
• Setting the date and time on the instrument (687)
Roche Diagnostics
Setting the time switch 657
Setting the day and time on the time switch

To synchronize the time switch, you must set the current
time and day of the week.
u Setting the time switch (656)
j m The OUT1 and OUT2 switches are set to AUTO.

m The OUT switches are set to PULSE.
r To set the day and time on the time

switch
1
1 Open the front panel of the core unit.
2
2 Set the timer toggle switch to OFF.
3 Open the lid.

11 Configuration
Roche Diagnostics
4
4 Set the mode switch to RUN.
5 Press the TIME ADJ key for 2 s or longer.

f On the display, the clock symbol starts flashing.
6
6 To set the day, press the day key of the current day, for
example, WED for Wednesday.
f On the display, the selected day is marked with a
bar (–).
7
7 Set the time:
• To increase the value, press the h or the min key.
• To decrease the value, press the HOLIDAY/ key
together with the h or the min key.
11 Configuration
8
8 To save the settings, press the WRITE key.
f The day and time are set.
Roche Diagnostics
Setting the start-up time on the time switch

To start up the instrument with the time switch, you must
program a start-up time for each work day.
j m The OUT1 and OUT2 switches are set to AUTO.

m The OUT switches are set to PULSE.
r To set the start-up time on the time

switch
1
1 Open the front panel of the core unit.
2
2 Set the timer toggle switch to OFF.
3 Open the lid.

11 Configuration
Roche Diagnostics
4
4 Set the mode switch to P1.
f If one or more programs are already set, they are
displayed.
f If no program is set yet, --:-- is displayed.
5 To add a new program, press the WRITE key repeatedly

until --:-- is displayed.
6
6 To select the days for a specific start-up time, press the
corresponding day keys.
f On the display, the selected days are marked with a
bar (–).
7
7 Set the start-up time:
• To increase the value, press the h or the min key.
• To decrease the value, press the HOLIDAY/ key
together with the h or the min key.
11 Configuration
8
8 To save the settings, press the WRITE key.
Roche Diagnostics
9
9 To increase the pulse duration to 5 s, press the
min/PULSE key.
f A delay of 5 s between the activation of the time
switch and the startup is set.
10
10 Press the WRITE key.
11 If you need different start-up times for different days of

the week, repeat steps 7 to 10 for the remaining days of
the week.
12
13 Close the lid.
13
11 Configuration
14
14 To activate the time switch, set the timer toggle switch
to ON.
Roche Diagnostics
15
16 Make sure that the instrument has been inspected since

the last power-off.
17
17 Power off the instrument.
f The time switch starts up the instrument at the set
time.
f After startup, if a power-on maintenance pipe is
configured, the instrument performs software-
controlled maintenance actions.
u Related topics
• Using the Power Up Pipe function (789)
A Power-off button
Setting holidays on the time switch

11 Configuration
You can set exceptions from the regular program, for

example, for public holidays.
Exceptions can be programmed up to 6 days in advance.

After the day with the exception has passed, the exception
is deleted automatically.
Roche Diagnostics
r To set holidays on the time switch
1
2 Press the HOLIDAY/ key for at least 2 s.

f The holiday setting mode is started.
3
3 To disable the automatic startup for a day, press the
respective day key.
f On the display, the bar (–) for this day is cleared.
4
4 Press the WRITE key.
f The automatic startup for this day will be canceled.
11 Configuration
Roche Diagnostics
Checking the programs on the time switch

You can check the programmed start-up times individually
for each day.
r To check the programming of the time

switch
1
2 Press the day key of the day you want to check for at
least 2 s.
f CHEC is displayed and flashes.
3
3 Check the displayed start-up time.
4 To display the pulse duration value, press the WRITE

key.
5
5 Make sure that the pulse duration is set to 5 s.
6 Press the WRITE key again.

11 Configuration
f END is displayed.
f The display returns to the initial state.
Roche Diagnostics
Deleting programs on the time switch

You can delete a single program or all programs at once.
q You cannot delete single days from a program.
r To delete programs on the time

switch
1
1 Open the lid.
2
2 Set the mode switch to P1.
11 Configuration
3
3 To select a single program for deletion:
• To select the program, press the WRITE key
repeatedly.
• Press the CLEAR key briefly.
f CLR - STEP is displayed.
Roche Diagnostics
4
4 To select all programs for deletion:
• Press the CLEAR key for at least 1 s.
f CLR - ALL is displayed.
5
5 To delete the selected programs, press the WRITE key.
I If you want to cancel the selection, press the CLEAR
key while CLR - STEP or CLR - ALL is displayed.
6
11 Configuration
Roche Diagnostics
Defining system settings 667
Defining system settings

This section describes the more frequently used
configuration buttons on the Utility > System submenu.
To access this submenu, you need administrator access

rights.
The other buttons are described in the Online Help of the

Utility menu.
u Utility menu (1657)
w Configuration buttons described in this section

11 Configuration
Roche Diagnostics
668 Defining system settings
q After changing any of the system settings, we

recommend creating a backup disk.
In this section
Creating operator IDs (668)
Rack assignment (670)
Assigning tests and test profiles to test keys (682)
Setting the date and time on the instrument (687)
Activating Rack Reception mode (688)
Defining settings for the incubators of cobas c
modules (690)
Defining settings for rack delivery (691)
Defining settings for the reagent manager of the c 702
module (693)
Defining settings for the e 801 module (695)
Defining reagent levels for yellow and purple reagent
alarms (700)
Defining reagent levels for reagent loading on the c 702
module (702)
Creating operator IDs

To access the instrument, each user and administrator
needs a unique operator ID and password.
Operator ID The instrument supports up to 40 operator IDs.
Delete operator IDs from the system for users who no

longer work on the system.
Password When a user logs on for the first time, the instrument asks
to enter an initial password (up to 16 characters). The
instrument links the user’s password to the operator ID.
q If a user forgets the password, the administrator must

11 Configuration
delete the operator ID and create it again.
Access levels Administrators can assign one of the following access

levels to each operator ID:
Roche Diagnostics
Access level Access rights

Administrator Full access including configuration and
maintenance settings
Supervisor Access to the basic system and
application settings as well as operator
access rights
Operator Access to the daily operation tasks and
maintenance functions only
y Access levels
q Assign access rights to each user only as high as

required for the user’s tasks.
u Access levels of each menu and window (1666)
r To create operator IDs
1
1 Choose Utility > System > Operator List.
2
2 Select an empty line.
11 Configuration
Roche Diagnostics
4
4 Enter an operator ID and select an access level.
6 If you need another operator ID, repeat steps 2 to 5.
u Related topics
• Input Operator ID window (1664)
• Password Protection window (1676)
Rack assignment
Rack assignment provides the following information to the
system:
• Container types used on the different racks
• Sample types allowed on the different racks
• Rack IDs of racks used for special purposes
(e.g., priority calibrator racks for specific modules)
In this section
About rack assignment (670)
About the rack assignment tables (672)
Assigning sample racks for standard containers (675)
Assigning sample racks for non-standard tubes (676)
Assigning sample racks for false bottom tubes (677)
Assigning sample racks for Sarstedt micro tubes on the
e 801 module (679)
Assigning calibrator and QC racks to modules (680)
Assigning QC racks for automatic QC (681)
About rack assignment

For each rack that you use, you must assign its rack ID or
11 Configuration
the rack ID range it belongs to, to a cell in the rack

assignment tables.
The system derives the following information from the

position of rack IDs in the rack assignment tables:
Information Examples
The container type on this rack Primary tube, non-standard tube, false bottom tube,
Sarstedt micro tube
The container geometry on this rack Height, bottom level, conical bottom (only false bottom tubes)
The sample type on this rack Serum/plasma or urine, for example
This rack is a priority calibrator rack for a specific module
y Information derived from the position of a rack ID in the rack assignment tables
Roche Diagnostics
Information Examples
This rack is a priority QC rack for a specific module
This rack carries QC material for automatic QC
y Information derived from the position of a rack ID in the rack assignment tables
q You must load a rack only with the containers and

sample types specified in the rack assignment tables.
The information derived from the rack assignment tables

complements the rack class information encoded in the
rack ID ranges.
The instrument needs all this information to process the

racks and the containers on them adequately, for example:
• To process STAT racks with priority
• To avoid crashing the sample probe into the bottom of
a false bottom tube
u Related topics
• Specifications of racks (2024)
range (565)
11 Configuration
Roche Diagnostics
About the rack assignment tables

The position of a rack ID in the rack assignment tables
(Utility > System > Rack Assignment) delivers information to
the system about the rack and the containers used on it.
w Rack assignment table for primary tubes and cups on primary tubes
q If there are routine or STAT samples in the database,

you cannot assign rack IDs. Before rack assignment, you
must delete the samples in Workplace > Data review.
About the tabs for container types

11 Configuration
You use the following tabs to assign different container

types to sample racks:
Tab Container type

Standard Primary tubes, cups on primary tubes
Non-Standard Non-standard tubes
y Tabs for assigning container types to sample racks
Roche Diagnostics
Tab Container type

False Bottom 1 False bottom tubes
Cups on non-standard tubes
Sarstedt micro tube
Sarstedt micro tube
y Tabs for assigning container types to sample racks
About the columns for racks with stabilizers
If you use racks with stabilizers, you must use the columns
on the left to enter their rack IDs. Racks with stabilizers do
not allow tube rotation.
About the columns for racks without

stabilizers
If you use racks without stabilizers, you must use the

columns on the right to enter their rack IDs. Racks without
stabilizers allow tube rotation.
q For tube rotation, the instrument must be equipped

with a tube rotation unit. You allow tube rotation in the
Rack Delivery dialog box.
u Defining settings for rack delivery (691)

11 Configuration
Roche Diagnostics
About the lines for sample types
Depending on the module, you can use several or all lines in

the rack assignment tables to assign sample types to
racks.
The following table specifies the possible sample types for

each module.
Line Sample type ISE module cobas c modules e 801 module e 602 module
1 Ser/Pl Serum/plasma l l l l
2 Urine Urine l l l l
3 CSF Cerebrospinal fluid l l l –
4 Suprnt (1) Supernatant l l l –
5 Others(2) Others l l l l
6 WhlBld Whole blood – – l –
7 OraFlu Oral fluid – – l –
8 Hemoly Hemolysate – – l –
9 AmniF Amniotic fluid – – l –
10 Stool Processed stool – – l –
y Possible sample types for each module
(1) On the c 502 module, this line is also used for whole blood.
(2) The sample type is designed for other body fluids than those mentioned for the specific module.
If you want to mix different sample types on one rack, use

the None fields to assign the respective rack ID range. In
this case, the host must send the sample type information.
About the columns for rack classes

(Routine/Rerun/STAT)
Each rack class has a specific rack ID range. You must use
11 Configuration
valid rack ID ranges, for example, 50001-50999 for sample

racks.
You can split up a rack ID range and assign subsets to

different sample types, for example:
• 50001–50160 for serum/plasma routine samples
• 50161–50180 for hemolysate routine samples
You only must assign rerun racks if you do manual rerun

tests in non-barcode mode.
Roche Diagnostics
About special calibrator and QC racks The system identifies the calibrator and QC racks by their
rack IDs, for example:
• 20001–20999 for calibrator racks (black)
• 30001–30999 for QC racks (white)
On the Module Settings tab, you can assign calibrator and

QC racks to specific modules in order to have these racks
transported directly to the assigned modules.
On the Module Settings tab, you can assign QC racks for

automatic QC.
u Related topics
• Rack Assignment window (1677)
• List of racks with stabilizers (2027)
• List of racks without stabilizers (2028)
Assigning sample racks for standard containers

The instrument recognizes all standard containers except
micro cups by their dimensions.
The following containers are standard containers:

• Primary tubes (∅13 mm or 16 mm, height 75 mm or
100 mm)
• Sample Cups
• Micro cups
• Sample Cups or micro cups on primary tubes
q The instrument cannot detect micro cups by their

dimension. You must select the Micro option in Workplace
> Test Selection or on the host.
11 Configuration

m All routine and STAT samples have been deleted from
the database.
Roche Diagnostics
r To assign sample racks for standard

containers
1
1 Choose Utility > System > Rack Assignment.
2
2 On the Standard tab, enter the rack ID ranges of the
sample racks you want to use for standard containers.
I The routine, rerun, and STAT rack classes each have
their own rack ID ranges. Make sure that you enter
valid rack ID ranges in the corresponding columns.
u Related topics
range (565)
• List of standard containers (2031)
Assigning sample racks for non-standard tubes

The instrument does not recognize the height of non-
standard tubes automatically. You must assign a rack ID
range for non-standard tubes. Then the instrument
determines all containers on these racks as non-standard
tubes, regardless of their height.
Non-standard tubes are tubes that comply to the

specifications for non-standard tubes.
11 Configuration

the database.
Roche Diagnostics
r To assign sample racks for non-

standard tubes
1
2
2 On the Non-Standard tab, enter the rack ID ranges of
the sample racks you want to use for non-standard
tubes.
valid rack ID ranges into the corresponding
columns.
u Related topics
• List of non-standard tubes (2033)
Assigning sample racks for false bottom tubes

To prevent the sample probe from crashing into the bottom
of a false bottom tube, you must provide the dimensions of
the false bottom tube. The instrument recognizes the type
of false bottom tube by the rack ID.
Cups on non-standard tubes must be assigned as false

bottom tubes.
On the c 701, c 702, and e 801 modules, you can use

3 different types of false bottom tubes. However, if a
c 502 or e 602 module is part of the instrument, you can
only use one type of false bottom tube.
11 Configuration
You must use only one type of false bottom tube on each
sample rack.
q If you want to use false bottom tubes either for auto

QC racks or for manual QC measurements, contact your

the database.
Roche Diagnostics
r To assign sample racks for false

bottom tubes
1
2
2 On the False Bottom 1 tab, enter the rack ID ranges for
a specific type of false bottom tube or cup on a non-
standard tube.
valid rack ID ranges into the corresponding
columns.
3
3 Choose the False Bottom Settings button.
4
4 Measure the container height (A) and the bottom level
(C) of the false bottom tube.
I Bottom level: Distance from the base position below
the rack rubber disk to the bottom level inside the
tube.
C
11 Configuration
A Container height C Bottom level

B Rack rubber disk (inside sample rack)
Roche Diagnostics
5
5 In the False Bottom Settings dialog box, enter the
container height and the bottom level of the false
bottom tube.
I Make sure that you enter the correct dimensions.
Otherwise, the sample probe might crash into the
bottom of the tube.
6 If the false bottom tube has a conical bottom, select

the Conical Bottom check box.
8
8 If you want to use more than one type of false bottom
tube, repeat steps 2 to 7 on the False Bottom 2 tab or
the False Bottom 3 tab. You can use up to 2 more types
of false bottom tubes.
I If a c 502 or e 602 module is part of the instrument,
you can use only one type of false bottom tube.
u Related topics
• List of false bottom tubes (2034)
Assigning sample racks for Sarstedt micro tubes on the e 801 module
The Sarstedt micro tubes are only used on the e 801
module.

the database.
r To assign sample racks for Sarstedt

micro tubes on the e 801 module
11 Configuration
1
Roche Diagnostics
2
2 On the False Bottom 2 tab, enter the rack ID ranges of
the sample racks you want to use for the Sarstedt micro
tubes.
I You must use a different tab each for Sarstedt
micro tube 0.5 mL and Sarstedt micro tube 2 mL.
3
3 Choose the False Bottom Settings button.
4
4 Select the Special micro cup (only e 801) check box.
5 Select the type of Sarstedt micro tube you want to use.
7
7 If you want to use the other type of Sarstedt micro tube
also, repeat steps 2 to 6 on the False Bottom 3 tab.
u Related topics
• List of Sarstedt micro tubes (2035)
Assigning calibrator and QC racks to modules

To assign specific calibrators or QC materials directly to a
single module, you must define module-specific calibrator
and QC racks.
11 Configuration
You cannot use the same rack range for module-specific

calibrator and QC racks on multiple modules.

the database.
Roche Diagnostics
r To assign calibrator and QC racks to

modules
1
2
2 Choose the Module Settings tab.
3
3 If you want specific calibrator racks to be transported
directly to specific modules, in the Calibrator columns,
enter the respective rack ID ranges.
I Valid calibrator rack IDs are 20001-20999.
4 If the calibrator racks can be processed on any module,

enter “0” in all fields of the Calibrator columns.
5
5 If you want specific QC racks to be transported directly
to specific modules, in the Control columns, enter the
respective rack ID ranges.
I Valid QC rack IDs are 30001-30999.
6 If the QC racks can be processed on any module, enter

“0” in all fields of the Control columns.
u Related topics
11 Configuration
Assigning QC racks for automatic QC

To use auto QC, you must define auto QC racks.
The following types of sample containers should be used

for Auto-QC samples:
• 75-100 mm tube
• RD control vial
u List of standard containers (2031)
Roche Diagnostics

the database.
r To assign QC racks for automatic QC
1
2
2 Choose the Module Settings tab.
3
3 In the Auto QC Racks group box, enter the rack ID range
of the QC racks you want to use for automatic QC.
I Valid QC rack IDs are 30001-30999.
u Related topics
• Configuring automatic QC (740)
Assigning tests and test profiles to test keys

To be able to select tests and test profiles on the
Workplace > Test Selection submenu, you must assign test
11 Configuration
keys to them.
Test keys The test keys are arranged on sheets. For each sample
type, there are 6 sheets with 32 test keys each (192 test
keys per sample type).
You can use the sheets for groups of tests. You can name
the tag of each sheet, for example, Hormones, Thyroid, or
Tumor Markers.
Roche Diagnostics
Test profiles A test profile is a set of tests that are selected together
using only one test key.
In the Start > Default Profile dialog box, you can assign a
default test profile to each sample type. The default test
profile is used if no tests have been selected for a sample.
u Default Profile window (1486)
r To define a group name for a test

selection sheet
1
1 Choose Utility > System > Key Settings.
2
2 From the Type drop-down list, choose a sample type,
for example, Ser/Pl.
3
3 Choose a sheet tab, for example, the Sheet 4 tab.
11 Configuration
4
4 In the Group Name field, enter a group name, for
example, “Thyroid”.
Roche Diagnostics
5
r To define a test profile
1
2
2 From the Type drop-down list, choose a sample type,
for example, Ser/Pl.
I Test profiles are sample type specific.
3
3 Choose the Profile Setting button.
4
4 In the Profile List list, select an empty line.
I You can define up to 20 test profiles.
11 Configuration
5
5 In the Profile Name field, enter the name of the test
profile, for example, TFT.
Roche Diagnostics
7
7 In the Profile Setting Menu group box, add tests to the
test profile, for example, TSH and A-TSHR.
I When adding serum index tests, add the S.IND test.
Do not add the SI or S-SI2 tests.
r To assign a test or test profile to a

test key
1
2
2 Choose a test key.
3
3 In the Test Key Setting dialog box, choose a test or test
profile, for example, TFT.
I If you want to delete a key assignment, choose
None.

11 Configuration
I Test keys with test profiles are displayed with a

brown bar.
Roche Diagnostics
5
5 To assign more tests or test profiles to test keys,
repeat steps 2 to 4.
6
u Related topics
• Key Settings window (1695)
11 Configuration
Roche Diagnostics
Setting the date and time on the instrument

To synchronize the instrument with the data manager and
the time switch, you must set the date and time on it.
q You must first set the date and time on the data
manager.

m The date and time on the data manager are set.
u Operator’s Manual of the data manager
r To set the date and time on the

instrument
1
1 Choose Utility > System > Display Settings.
2
2 Choose a date format and set the date and time.
11 Configuration
Roche Diagnostics
4
I The date and time are set when the instrument is
powered on again.
u Related topics
• Setting the time switch (656)
• Display Settings window (1702)
A Power-off button
Activating Rack Reception mode

If you do not want the instrument to return to Standby
mode after each analysis run, you must activate Rack
Reception mode. In this case, the instrument stays ready to
process further sample racks immediately.
q You can temporarily disable Rack Reception mode in

the Start dialog box.
u Start window (1473)

11 Configuration
m The instrument is not connected to a pre-analytical

system
Roche Diagnostics
r To activate Rack Reception mode
1
1 Choose Utility > System > Rack Reception.
2
2 Select the Rack Reception Mode check box.
I If the instrument is connected to a pre-analytical
system, the check box is disabled.
3
3 From the Hours drop-down list, choose a time period for
the remaining time until the instrument shall switch to
Standby mode.
I The remaining time in Rack Reception mode is
displayed in the status line.
4
4 If you want the instrument to stop washing the reaction
cells of the cobas c modules during Rack Reception
mode, select the Stop Washing check box.
I When you press the Start button during Rack
Reception mode with the Stop Washing check box
11 Configuration
selected, wait for at least 6 seconds before you

press the Start button again.
If your system does not have a cobas e module, it is
not necessary to set stop washing ON.
5
5 If you want the instrument to wash the reaction cells of
the cobas c modules continuously during Rack
Reception mode, clear the Stop Washing check box.
I If auto QC materials are measured during Rack
Reception mode, you must not select the Stop
Washing check box. The instrument resumes
washing reaction cells with the next analysis run.

Roche Diagnostics
u Related topics
• Rack Reception window (1704)
Defining settings for the incubators of cobas c modules

For the cobas c modules, you must define the reaction cell
in the incubator at which the instrument starts measuring.
To prevent contamination of the incubation bath, you must
adjust the incubation bath exchange rate to the quality of
the deionized water supply.
r To define settings for the incubator
1
1 Choose Utility > System > Analyzer Settings.
2
2 If you want the cobas c modules to start measuring at
the reaction cell next to the reaction cell last used,
select the Variable Start Cell No. check box.
f The Reset button is now enabled. With the Reset
button you can reset the start reaction cell number
for the next analysis run to 1.
11 Configuration
3
3 If you want the cobas c modules to start measuring at
reaction cell 1 always, clear the Variable Start Cell No.
check box.
Roche Diagnostics
4
4 If the deionized water quality is not satisfactory in terms
of bacteria, select the Incubation Water Exchange
check box.
f The incubation baths are exchanged more often
and with more ECO-D added.
5
5 If the deionized water supply is bacteria-free, clear the
Incubation Water Exchange check box.
I Only clear the Incubation Water Exchange check
box if the incubation bath is exchanged daily and
the incubator is cleaned at least once a month.
6
6 From the drop-down list, choose the Ecotergent option.
u Related topics
consumption (2009)
• Analyzer Settings window (1706)
Defining settings for rack delivery

To enable fast processing of STAT racks, you must reserve
positions for them on the module sample buffers (MSB). If
you use racks without stabilizers, you must activate tube
rotation. For backup operation, you must specify a
container type. To optimize the turnaround time of
11 Configuration
samples, you can reduce the number of racks admitted to

the instrument.
Roche Diagnostics
r To define settings for rack delivery
1
1 Choose Utility > System > Rack Delivery.
2
2 In the Stat Rack Number field, enter a number from
1 to 17 to define the total number of positions on the
MSBs reserved for STAT racks.
I You must reserve at least one position for STAT
racks. Otherwise, the MSBs may be full and the
STAT rack must wait until a rack is transported to
the output buffer.
3
3 If the instrument receives racks without stabilizers from
a pre-analytical system, select the Sample Tube
Rotation check box to activate tube rotation.
4
4 If you use racks with stabilizers, clear the Sample Tube
Rotation check box.
11 Configuration
Roche Diagnostics
5
5 From the Backup Operation Sample Height drop-down
list, choose a primary tube, cup, or cup on primary tube
to specify the container type for backup operation.
I During backup operation, the instrument cannot
distinguish between different standard containers.
If you use a wrong container, the sample probe may
crash into the bottom of the container.
Make sure, you only use the container specified for
backup operation.
6
6 To optimize the throughput of the instrument, choose a
percentage from the Loading Rack Limit drop-down list
to reduce the number of racks admitted to the
instrument.
I The default percentage is 100%. We recommend
reducing the percentage step by step until you are
satisfied with the turnaround time of racks.
u Related topics
mode (644)
• Rack Delivery window (1708)
Defining settings for the reagent manager of the c 702

module
For the c 702 module, you can set a time at which the
reagent manager unloads the reagent cassettes due for
unloading in the reagent disk.
11 Configuration
q In the Start dialog box, you can disable the automatic

unloading of reagent cassettes.
u Start window (1473)
For automatic loading during Operation mode, you can

reserve a number of positions per reagent disk to remain
empty for new reagent cassettes.
Roche Diagnostics
Automatic loading during Operation mode is triggered by

reagent cassettes which are in one of the following
conditions:
• Reagent cassette with a remaining volume < 15 tests
• Reagent cassette selected for loading on the reagent
manager
• Reagent cassette loaded with caps removed
• Reagent cassette with onboard stability ≤ 0
r To define settings for the reagent

manager of the c 702 module
1
1 Choose Utility > System > Reagent Manager Settings.
2
2 If you want the reagent manager of the c 702 module
to unload reagent cassettes due for unloading at a set
time, select the Time to Unload Mode check box.
3 In the Set Time fields, enter the time (hh:mm) at which

the reagent manager is supposed to start unloading.
I The reagent manager only starts unloading if the
c 702 module is not in Operation mode, for example,
in Rack Reception mode.
4 To reserve a number of positions per reagent disk for

new reagent cassettes loaded during automatic
11 Configuration
loading, enter the number of positions in the Vacant

Slot field.
I In addition to this number, the instrument always
retains one position on each reagent disk reserved
for the normal loading/unloading of reagent
cassettes.
Roche Diagnostics
u Related topics
• About changing reagent cassettes on the c 702
module (346)
• Reagent Manager Settings window (c 702
module) (1718)
Defining settings for the e 801 module

By selecting the Quick Start Mode check box, you can
reduce the time for starting a measurement from Standby
mode to typically 6:30 minutes.
By selecting the Reagent Expired Mask check box, you can

mask expired reagent cassettes and expired ProCell II M
bottles (lot expired).
Expired reagent cassettes are selected for unloading and

not used for tests anymore. Expired ProCell II M bottles are
not used for tests anymore.
q This selection is invalid for items not permitted in the

application file.
With the Foam Detection check boxes, you can enable or

disable image processing in the camera and
communication to the analyzer.
In this section
About the quick start mode on the e 801 module (696)
About reagent expired masking on the e 801 module (697)
Defining quick start mode and masking of expired reagents
About foam detection on the e 801 module (699)
11 Configuration
Roche Diagnostics
About the quick start mode on the e 801 module

It takes approximately 12 minutes to start a measurement
from Standby mode because the instrument passes the
Preparation mode first. To shorten the time until
measurement begins, choose the quick start mode for the
e 801 module.
Functionality of the quick start mode
When you select the Quick Start Mode check box on Utility
2SHUDWLRQZRUNÁRZ > System > Immune Analyzer Settings, the instrument skips
some steps in Preparation mode and Post Operation mode,
Quick Start Mode for example, the maintenance action reagent prime. This
functionality enables the instrument to switch from
On Off Standby mode into Operation mode in approximately
6:30 minutes. With the quick start mode enabled, the
1
Power On reagent prime is only performed once in the Initialize mode.
In some cases, it may take longer than 6:30 minutes to

Initialize mode
reach Operation mode. Examples of reasons: You open and
12 min 9 min
close the top cover during Initialize mode, or you have
Standby mode
recently replaced a system reagent bottle.
If the instrument has been in Standby mode for more than

2
Operation Start 8 hours, the reagent prime is performed during Preparation
mode. Then the instrument switches to Operation mode in
approximately 12 minutes.
Preparation mode
6:30 min 12 min
u Related topics
Operation mode
Post Operation mode
Standby mode
3
Power Off
11 Configuration
Roche Diagnostics
About reagent expired masking on the e 801 module

If the Reagent Expired Mask check box is selected, the
e 801 module cannot use expired reagents for the
measurement, and expired reagents are automatically
selected for unloading.
The Reagent Expired Mask check box applies to the

following:
• The expiry date, not the onboard stability
• Assay reagents and linked pretreatments reagents
• Linked reagents that are part of linked kits
• ProCell II M bottles
! WARNING
reagents
Results based on expired reagents are not reliable.
r Do not use reagents that have exceeded their expiry
date or onboard stability.
r If you clear the Reagent Expired Mask check box, select
the Expired Reagent Flag check box in Utility > System
> Alarm Settings. Then the data alarm ReagEx is
attached to results based on expired reagents.
u Related topics
• Immune Analyzer Settings (e 801 module) (1719)
11 Configuration
Roche Diagnostics
Defining quick start mode and masking of expired reagents on the e 801
module
For the e 801 module, you can reduce the transfer time
from Standby mode to Operation mode from 12 minutes to
6:30 minutes. You can also make the instrument mask
expired reagent cassettes and ProCell II M bottles.
q Expired reagents are not automatically selected for

unloading and may still be used for tests if not masked.
r To define settings for the e 801

module
1
1 Choose Utility > System > Immune Analyzer Settings.
2
2 If you want the e 801 module to transfer from Standby
mode to Operation mode in only 6:30 minutes instead
of 12 minutes, select the Quick Start Mode check box.
f The e 801 module skips the reagent prime during
Preparation mode. However, if the module has not
been in Operation mode for more than 8 hours, the
reagent prime is performed.
11 Configuration
3
3 To mask expired reagent cassettes and expired
ProCell II M bottles (lot expired), select the Reagent
Expired Mask check box.
I This selection overrules masking information
encoded in the application files.
f Expired reagent cassettes and ProCell II M bottles
are selected for unloading and not used for tests
anymore.
Roche Diagnostics
u Related topics
• About the quick start mode on the e 801 module (696)
• About reagent expired masking on the e 801
module (697)
About foam detection on the e 801 module

Administrators can enable or disable image processing for
foam detection in the camera and the communication to
the analyzer.
You can select the Foam Detection check boxes for each
sample container type separately.
• If the check box is selected and foam is detected in the
sample container, no measurement of the affected
sample is performed. In addition, an instrument alarm is
issued and the data alarm Samp.B is attached to the
order.
• If the check box is not selected, the result of the foam
detection remains unconsidered. No data alarm is
attached to the results.
q Foam detection can be used for the following sample

containers:
o Standard containers with or without cups (Sample Cup
or Hitachi Micro-Sample Cup)
o 0.5 or 2.0 mL Sarstedt micro tubes on 13 x 82 mm
tubes
o False bottom tubes
q For non-standard tubes, calibrator and QC vials, the

foam detection is always inactive.
11 Configuration
Roche Diagnostics
Defining reagent levels for yellow and purple reagent

alarms
To ensure a sufficient reagent supply during operation, you
must define 2 reagent levels for each reagent. The reagent
levels trigger a yellow or a purple reagent alarm
respectively.
q If a diluent is empty or not on board, tests that need

the diluent are not masked. We recommend assigning
reagent alarm levels to diluents.
Reagent level For test reagents, the reagent level is the number of
remaining tests in the reagent cassette. For diluents, wash
solutions, and ECO-D, the reagent level is the volume in mL
remaining in the respective container.
For immunology tests with linked reagent cassettes, the

reagent level is the lowest number of remaining tests in the
reagent cassettes involved.
On the e 801 module, you can set the reagent level

separately for each type of diluent and system reagent.
Reagent alarms The alarm colors of the reagent alarms indicate the
following:
Alarm color Meaning Required action

The reagent level is below the At the beginning of the work shift, you must provide enough
daily requirement. reagent cassettes for the day.
The reagent level is below the You must provide a new reagent cassette as soon as possible.
caution level.
The reagent is empty or You must provide a new reagent cassette immediately.
missing.
y Alarm colors of reagent alarms
q To display the purple reagent alarms, on the Overview

11 Configuration
menu, choose the Preventive Action check box.

Reagent alarms are issued on the following menus and

submenus:
• Overview
• Reagent > Setting
• Reagent > Status
Roche Diagnostics
r To define reagent levels for yellow

and purple reagent alarms
1
1 Choose Utility > System > Reagent Level.
2
2 Choose a test, wash solution, or diluent.
3
3 In the Yellow Alarm group box, select the Activate Alarm
check box.
4 In the Activate Alarm field, enter a reagent level:

• For a test reagent, enter the number of remaining
tests below which the system shall issue a yellow
reagent alarm.
• For system reagents, diluents, wash solutions, and
ECO-D, enter a volume in mL.
5
5 In the Purple Alarm group box, select the Activate Alarm
check box.
6 In the Purple Alarm field, enter a reagent level:

• For a test reagent, enter the number of remaining
tests below which the system shall issue a purple
reagent alarm.
11 Configuration
• For system reagents, diluents, wash solutions, and

ECO-D, enter a volume in mL.
8 Repeat steps 2 to 7 to define more reagent levels for

yellow and purple reagent alarms.
Roche Diagnostics
Defining reagent levels for reagent loading on the c 702

module
On the c 702 module, you can define reagent levels that
trigger reagent loading outside Operation mode. This
ensures the timely supply of reagents to the reagent disks
without the reagent manager disrupting operation.
If the number of remaining tests in a reagent cassette is

below 15, the reagent manager loads a replacement
reagent cassette even if the module is in Operation mode.
Reagent level For test reagents, the reagent level is the number of
remaining tests in the reagent cassette. For diluents, wash
solutions, and ECO-D, the reagent level is the remaining
volume in mL.
You must define the following reagent levels:
Reagent level Triggers the following function

Yellow Loading Limit The reagent manager loads
the reagent cassette as soon
as the module is in Standby
mode or Rack Reception mode.
The reagent cassette must be
available on the rotor of the
reagent manager.
Initial Loading Limit The reagent is added to the
reagent load/unload list. You
must load those reagents at
the loading port of the reagent
manager.
y Reagent levels on the c 702 module
The value of the Initial Loading Limit must be greater than

the value of the Yellow Loading Limit. Then you have time to
load the required reagent cassettes at the loading port
before the reagent manager transports them to the
reagent disks.
j
11 Configuration
r To define reagent levels for reagent

loading on the c 702 module
1
1 Choose Utility > System > Reagent Loading Level.
Roche Diagnostics
2
2 From the list, choose a test, wash solution, or diluent.
3
3 In the Yellow Loading Limit group box, enter the reagent
levels below which the reagent manager must load a
new reagent cassette.
• For test reagents, enter the number of remaining
tests.
• For diluents, wash solutions, and ECO-D, enter a
volume in mL.
I The reagent cassettes are loaded at the next
opportunity outside Operation mode.
4
4 In the Initial Loading Limit group box, enter the reagent
levels below which the system must add the respective
reagent to the reagent load/unload list.
I The value of the Initial Loading Limit must be greater
than the value of the Yellow Loading Limit.
6 Repeat steps 2 to 5 for the other reagents.
u Related topics
• About changing reagent cassettes on the c 702
module (346) 11 Configuration
Roche Diagnostics
704 Installing applications
Installing applications
Before you load the corresponding reagent cassette for a
new application, you must install all necessary data.
Installing applications
In this section
Installing new applications (overall presentation) (704)
1
Download a new
1
Update an existing
Downloading and updating application settings (710)
application application About development channel applications (720)
About the HbA1c test on the c 502 module (721)
2 About result calculation of the HbA1c test (722)
&RQÀJXUHWKHDSSOLFDWLRQ
Installing the HbA1c test on the c 502 module (723)
Installing the serum index application on cobas c
• Calibrator data modules (728)
• QC material data
• Additional settings
3
)LQDOL]HWKHLQVWDOODWLRQ
• Load reagent cassettes

• Calibrate the test
• Perform QC measurement
Installing new applications (overall presentation)

To install a new application, you must first download all
necessary data from cobas® link via the data manager.
Then, you must configure the application settings, the
calibrator data, the QC material data, and necessary
additional settings.
q You can also install new applications for embedded

tests on the e 801 module.
11 Configuration
u Overview of cobas® link (246)

Administrators can download the application settings
of any application and release.
Supervisors can only download the application settings
of the newest and the current release of an already
installed application.
Roche Diagnostics
Installing applications 705
r To configure new application settings
1
1 In Utility > Application > Download, download the new
application settings.
2
2 If necessary, configure the application settings on
Utility > Application.
3
3 In Utility > System Configuration > Test Assignment,
assign the application to a module.
4
4 In Utility > System > Key Settings, assign the application
to a test key or profile.
11 Configuration
5
5 In Utility > System > Reagent Level, define the reagent
warning levels.
I For c 702 modules, we recommend defining an
initial loading limit in Utility > System > Reagent
Loading Level.
Roche Diagnostics
6
6 For cobas c modules: In Utility > Application > Chemistry,
choose the Download button to download the diluent
and wash solution data.
I Only for the first registration of diluents or wash
solutions, a download is required.
7
7 For cobas c modules: In Calibration > Status
> Instrument Factor, define an application-specific
instrument factor for certain applications, as
recommended in the Instructions for Use.
r To configure calibrator data
1
1 In Calibration > Install, download the calibrator data.
2
2 On Utility > Application > Other, check that volumes are
defined for each calibrator.
I For cobas c modules: If an application misses these
calibrator data, a red alarm (Calibration Parameter
Error) is issued.
11 Configuration
3 For non-barcoded calibrators, assign a rack ID and rack

3
position on Calibration > Calibrators > Rack Assign.
I For cobas c modules: If an application misses these
calibrator data, a red alarm (Calibration Parameter
Error) is issued.
Roche Diagnostics
r To configure QC material data
1
1 In QC > Install, download the QC material data.
2 For non-barcoded QC material, assign a rack ID and

2
rack position on QC > Controls > Rack Assignment.
3
3 If necessary, configure automatic QC measurement:
• Choose Utility > System > Calib. and QC Settings.
• In the QC Settings group box, select the
corresponding check box for automatic QC
measurement.
4
4 If you work with non-Roche QC material, do the
following:
• On the data manager, configure the QC material
data using the QC material component.
• Download the non-Roche QC material data to the
11 Configuration
instrument.
5 On the data manager, assign a QC rule using the

Westgard rule assignment component.
I QC rules are used to validate QC results. For a test,
you can create and evaluate several QC rules, for
example, Westgard rules, in parallel.
Roche Diagnostics
r To configure additional settings
1
1 If necessary, configure a special wash on Utility
> Special Wash:
• Program a special wash: In the Reagent Probe
submenu in the User Rule list, select a row and
choose the Edit button.
• From the data manager, download and install a
special wash: Choose the Download button and
select the special wash rule to be downloaded.
2
2 If necessary, perform the following settings on the data
manager:
• Configure a formula.
• Program a validation range.
• Program actions, for example, reflex tests.
• Select or clear the Ignore validation range check
box.
• Select or clear the Validate repetitions check box.
• Deactivate the Automatic patient masking when QC
error option.
• Activate or deactivate the Relevant for validation
option.
r To finalize the installation
1
1 Load the reagent cassettes.
11 Configuration
Roche Diagnostics
2
2 To calibrate the tests, do the following:
• Choose Overview > Calib. and QC Select.
• In the Calibration group box, choose the
Recommended button.
3 To perform QC measurements, do the following:

• Choose Overview > Calib. and QC Select.
• In the QC group box, choose the Recommended
button.
4
4 To perform a backup of the system parameters, in
Utility > Maintenance > Maintenance, choose the
(14) Parameter Read/Write option.
u Related topics
- Downloading new application settings (710)
- Assigning tests to the ISE module (762)
- Assigning tests and test profiles to test keys (682)
- Defining reagent levels for yellow and purple
reagent alarms (700)
• Calibrator data
- Installing calibrator data from the data
manager (488)
- Assigning non-barcoded calibrators to rack
positions (494)
• QC material data
- Installing QC material data from the data
manager (531)
- Assigning non-barcoded QC material to rack
positions (535)
• Diluent and wash solution data:
- Downloading application settings for diluents and
detergents for cobas c modules (713)
• Downloading special wash data (752)
• Operator’s Manual or the Online Help of the data
manager
11 Configuration
• Saving system parameters (617)

• Defining reagent levels for reagent loading on the
c 702 module (702)
Roche Diagnostics
Downloading and updating application settings

Before you load the corresponding reagent cassette for a
new application, you must download and install all
necessary data.
When you update an already installed application, you

must take some measures before and after downloading
the new application settings.
In the Overview menu, the Parameter Download button

indicates that new parameters are available for download
from cobas® link via the data manager.
Updated or new parameters are available for installed

applications.
Important parameters are required by the instrument.
In this section
Downloading new application settings (710)
Downloading application settings for diluents and
detergents for cobas c modules (713)
About updating application settings (715)
List of editable application settings (716)
Updating application settings on cobas c modules (717)
Updating application settings on cobas e modules (719)
Downloading new application settings

When you install a new application, you must first
download all necessary data from cobas® link via the data
manager.
You can install up to 4 applications per cobas c pack on the

instrument, for example, the Ca standard application
11 Configuration
(ACN 8706, 10 min) and the corresponding STAT

application (ACN 8726, 3 min).
For regular immunology tests, each reagent cassette is

dedicated to an application. For multi-application tests on
the e 801 module, you can install up to 4 applications per
cobas e pack green.
Roche Diagnostics

r To download application settings
1
1 Choose Utility > Application > Download.
2
2 To preselect the applications, choose one of the
following Search Using options:
• To get a list of all applications, choose the All Item
option.
• To get a list of onboard reagents for which the
application settings have not yet been downloaded,
choose the Required Item option.
• To display the Application Code field, choose the
Application Code option.
• To display the Application Name drop-down list,
choose the Application Name field.
• To display the R. Pack ID field for entering the
reagent cassette number, choose the R. Pack ID
option.
Different terms are used for reagent cassette
number. In the software, the reagent cassette
number is called R. Pack ID. On the reagent
cassettes, the reagent cassette number is called
System-ID.
I If you know the ACN, we recommend using the
Application Code option.
11 Configuration
The ACN is available in the Instructions for Use of

the corresponding reagent cassette.
Up to 4 applications per reagent cassette are
possible.
3
Roche Diagnostics
4
4 In the Result list, select the application to be
downloaded.
5
6
6 In the Confirmation dialog box, check the following
application settings:
• From the Test No. drop-down list, check that the
test number is correct.
• In the Application Name field, check that the
application name is correct.
• If you download an immunology application, check
that the Sample Type is correct.
• From the Unit drop-down list, check that the
measurement unit is correct. For copy calibrations
on e 801 modules, select the same measurement
unit for the master application and all additional
applications. This is necessary to enable copy QC
on the data manager because the additional
applications use the same control ranges.
• If a reagent lot is on board and you request the
corresponding application for download, choose
the release in the Current Release Date drop-down
list.
• If you install a new application and you have
administrator access rights, choose the release in
the Addition Release Date drop-down list.
• If you update an existing application and you have
administrator access rights, choose the release in
the Update Release Date drop-down list.
11 Configuration
I Once the application settings have been

downloaded, the application name and the
measurement unit cannot be changed. To change
the application name or the measurement unit, you
must delete and again download the application
settings.
For copy calibrations, the master application and all
additional applications must use the same
measurement unit. If you change the measurement
unit for one of the applications (master or additional
application), you must change it for all other
applications that use the same copy calibration.
Therefore, you need to reinstall the applications.
Roche Diagnostics
7 To start the download, choose the OK button.

f The screen is unavailable until the download is
finished.
9
9 On Utility > Application > Other, check the following
settings:
• In the Sample Volume fields, check that volumes are
defined for each calibrator.
• In the Rack Assign fields, check that Assigned is
displayed for each non-barcoded calibrator.
f If one of these parameters is missing for a
photometric application, a red alarm (Calibration
Parameter Error) occurs.
u Related topics
• Installing new applications (overall presentation) (704)
• About updating application settings (715)
• Updating application settings on cobas c
modules (717)
• Updating application settings on cobas e
modules (719)
Downloading application settings for diluents and detergents for cobas c

modules
When you install new diluents and wash solutions supplied
in reagent cassettes, you must first download the
respective application settings from cobas® link via the
data manager.
q For diluents on cobas e modules, application settings

cannot be downloaded.
Type Short name ACN

Detergent 1 NaOHD 947
11 Configuration
Detergent 2 SMS 948

Detergent 3 SCCS 949
Diluent NACL 951
Diluent A1CD2 952
y Downloadable diluents and wash solutions
Roche Diagnostics

r To download application settings for

diluents and detergents
1
1 Choose Utility > Application > Chemistry > Download.
2
2 Choose the Application Code option.
3 In the Application Code field, enter the ACN of the

diluent or wash solution.
4
5
5 In the Result list, select the check box of the application
to be downloaded.
11 Configuration
6
f The screen is unavailable until the download is
finished.

f On Utility > System > Utility Reagent Settings, the
downloaded data on registered diluents and wash
solutions is displayed.
Roche Diagnostics
u Related topics
• Downloading new application settings (710)
• Configuring a reagent probe wash for cobas c
modules (753)
• Configuring a reaction cell wash for cobas c
modules (755)
• Configuring a sample probe wash for cobas c
modules (757)
• Configuring special washes for cobas c modules (753)
About updating application settings

When you update an application, you can opt for
overwriting all application settings or for retaining all
application settings that can be customized.
• To download the new application with all new settings,
choose Overwrite. You do not need to delete the
application beforehand.
However, you must unload all corresponding reagent
cassettes beforehand.
• To retain all editable application settings, choose
Partial Overwrite.
• Check the application settings after download.
• Calibrate the test if this is indicated by the software.
In previous software versions (before 05-01), the updated

application did not change any editable application
settings.
Identification of application settings When you update an application, the ACN and the
application name remain unchanged. Therefore, installed
application settings are overwritten by updates.
The table shows which application settings are changed by

updates and how you can identify the latest version of an
application.
Application Changed by Indication of latest
11 Configuration
settings updates application settings

ACN Not changed
Application name Not changed
Version(1) Changed Highest version
number
Release date(1) Changed Latest release date
y Updates of applications
(1) Displayed in the Confirmation dialog box after the application has
been selected for download.
u Related topics
• List of editable application settings (716)
Roche Diagnostics
List of editable application settings

You can edit a number of application settings, others are
fixed. When you update an application, the instrument
treats editable and fixed application settings differently.
This is regardless of whether this application setting has
been edited or not.
If you choose the Partial Overwrite button before

downloading an updated application, all editable
application settings will be retained in the new version.
q The serum index is an exception. This is an editable

parameter but it is also overwritten if Partial Overwrite is
selected.
Utility Editable application settings

> Application
Application short name (Test column)
Analyze Sample Volume area:
o Dec.
o Sample volume
o Diluted sample volume
o Diluent volume
o Stirring level
Calib. Auto. Calibration area:
o Changeover of lot (chemistry)
o Changeover of reagent cassette
o Timeout of lot
o Timeout of reagent cassette
Auto. Masking check box
SD Limit (chemistry)
Duplicate Limit
Sensitivity Limit (chemistry)
S1 Abs. Limit (chemistry)
Range Control Interval check box and time setting
Technical Limit (chemistry)
Repeat Limit
Qualitative check box and settings
(chemistry)
Test Priority (immune)
11 Configuration
Serum Index Check Value for L, H, I

(chemistry and immune)
y List of editable application settings
Roche Diagnostics
Updating application settings on cobas c modules

When you update application settings, you must take some
module-specific measures before and after downloading
the new application settings from the data manager.

r To update application settings on

cobas c modules
1
1 If you have edited application settings manually, note
down your customized application settings on Utility
> Application.
2
2 Unload the reagent cassettes:
• For c 702 modules:
Unload the reagent cassettes for the corresponding
application.
11 Configuration
• For c 502 modules:

Unload and dispose of used and standby reagent
cassettes according to local regulations.
Roche Diagnostics
3
4
4 Choose one of the following:
• If you want to overwrite all parameters with the new
setting, choose the Overwrite button.
• If you want to overwrite only parameters that are
not editable, choose the Partial Overwrite button.
All editable parameters will retain their current
settings.
I Refer to the Application Sheet or Customer
Information letters whether partial overwrite is
recommended for this release.
5 If you have overwritten manually edited application

settings, reenter the customized application settings.
6
6 Load the reagent cassettes for the corresponding
application.
7 For c 701 and c 702 modules: Perform a reagent

registration.
8 If the Parameter Download button turns yellow, install

the updated calibrator data or QC material data from
the data manager.
9 Calibrate the newly loaded reagent cassettes.
10 If necessary, reassign the customized application

settings.
u Related topics
11 Configuration

manager (531)
Roche Diagnostics
Updating application settings on cobas e modules

When you update application settings, you must take some
module-specific measures before and after downloading
the new application settings from the data manager.

r To update application settings on

cobas e modules
1
1 Select the application settings:
• Choose Utility > Application.
• From the left list, choose the corresponding
application.
I Check the Application Sheet or Customer
Information letters whether deletion, overwriting or
partial overwriting are recommended for this
release.
2
• If you want to delete the application, choose the
Delete button. (u 710)
• If you want to overwrite or partial overwrite the
application, choose the Download button.
3
• If you want to overwrite all parameters with the new
setting, choose the Overwrite button.
• If you want to overwrite only parameters that are
11 Configuration
not editable, choose the Partial Overwrite button.

All editable parameters retain their current settings.
Roche Diagnostics
4
4 Load the reagent cassettes for the corresponding
application.
5 If the Parameter Download button turns yellow, install

the updated calibrator data or QC material data from
the data manager.
6 Calibrate the newly loaded reagent cassettes.

I For immunology tests, the software does not
request calibration. However, we recommend
calibrating the tests.
Former calibrations are deleted.
u Related topics
manager (531)
About development channel applications

To install a development channel application, you must
first install the application data from the respective CD to
the cobas® 8000 data manager. Subsequently, you must
download the application from the data manager to the
control unit and then configure the application settings,
calibrator data, QC material data, and necessary
additional settings.
In Utility > Application, all application fields are accessible

and you can enter parameters manually.
! WARNING
Incorrect results may occur when using
development channel applications
11 Configuration
r When using a non-Roche reagent, follow the instruction

of the non-Roche reagent supplier. For change of assay
parameters, consult with the non-Roche reagent
supplier.
Roche is not responsible for parameters that are not
correct.
Roche Diagnostics
q The installation of development channel applications

is described in the Instructions for Use of the cobas c pack
more information.
About the HbA1c test on the c 502 module

To monitor the long term concentration of glucose in the
blood, or to diagnose diabetes, the Hemoglobin A1c test
(HbA1c test) is performed.
Necessary applications To perform the HbA1c test, the A1C-3 whole blood
application with the following applications/reagents must
be installed.
Application/Reagent Short name ACN

Hemoglobin (Hb) HB-W3 871
Hemoglobin A1c (HbA1c) A1-W3 881
Ratio % HbA1c (acc. to DCCT/NGSP) RWD3 891
Hemolyzing reagent A1CD2 952
y Applications and reagents of the A1C-3 application
Sample type The supernatant (Suprnt) sample type is used for the
HbA1c whole blood test.
Clot detection is automatically deactivated when pipetting

whole blood samples.
q We recommend mixing whole blood samples manually

before loading to ensure accurate pipetting.
For the use of blood collection systems as sample tubes,
Containers for the HbA1c test For running the HbA1c test, only tubes with the following
specifications can be used:
11 Configuration
Container Rack assignment Diameter × length Dead volume

Sample tube Standard 13 mm × 75 mm 500 µL
(Primary tube) Standard 13 mm × 100 mm 500 µL
Standard 16 mm × 75 mm 1000 µL
Standard 16 mm × 100 mm 1000 µL
Sarstedt Monovette 2.7 mL Non-Standard 11 mm × 66 mm 1000 µL
Non-standard tubes Non-Standard 11–16 mm x 63–102 mm 1000 µL
Inner diameter > 9.7 mm
y Sample tubes for the HbA1c test
Roche Diagnostics
Container Rack assignment Diameter × length Dead volume

BD vacutainer 3.0 mL Standard 12 mm × 75 mm 600 µL
Sarstedt tube 5.0 mL Standard 13 mm × 75 mm 650 µL
Sarstedt tube 13.0 mL Standard 16 mm × 100 mm 1000 µL
y Sample tubes for the HbA1c test
For HbA1c whole blood QC measurements, Sample Cups

can be used. The Sample Cups must be placed directly on a
QC rack.
Reaction course After the hemolyzing process, first the quantitative amount
of hemoglobin and then the quantitative amount of HbA1c
is measured.
A B C D
70 %
30 %
Absorbance
C D
S, R1 R3
0 34 Cycle (time) 70
w Reaction course of the HbA1c application

A Sample pipetting For pipetting an EDTA whole blood sample, the sample probe is lowered to 70 % of the filling
volume.
B Hemolyzing process EDTA whole blood sample is pipetted into the predilution reaction cell and is hemolyzed with
hemolyzing reagent (A1CD2).
C Hemoglobin test Hemolyzed (prediluted) sample (S) and HB-W3 reagent (R1) are pipetted into the reaction cell
(1-point test, cycles 1–34).
D HbA1c test A1-W3 reagent (R3) is added (2-point test, cycles 34–70).
11 Configuration
About result calculation of the HbA1c test

The HbA1c test result is calculated according to IFCC
standardization. To calculate the HbA1c test results, you
must download the RWD3 application from Roche
Diagnostics.
You can select whether the results are reported as IFCC

values (mmol/mol Hb) or as DCCT/NGSP values (% Hb A1c).
Roche Diagnostics
To report the results according to IFCC or DCCT/NGSP,

refer to the installation procedure:
u Installing the HbA1c test on the c 502 module (723)
In step 6 of the installation procedure you program a

calculated test using the following formulas.
IFCC result report To report the results according to the IFCC

standardization, you must add a new supernatant sample
type test on the data manager under Test configuration
> Component > Test / reference ranges.
Enter the following formula in the Formula definition dialog

box:
A1-W3
z1 RWD3 = ------------------ ⋅ 1000
HB-W3
DCCT/NGSP result report To report the results according to the DCCT/NGSP

standardization, make sure that the following formula is
displayed in Utility > Application > Formula:
A1-W3
z2 RWD3 = ------------------ ⋅ 91.5 + 2.15
HB-W3
q For results according to the DCCT/NGSP

standardization, no settings are required on the data
manager.
Installing the HbA1c test on the c 502 module

To ensure accurate measuring for the HbA1c test and to
obtain results according to the IFCC or DCCT/NGSP
reporting range, you must install the HbA1c test according
to the following procedure.
d m Method Sheet of the A1C-3 application

11 Configuration
Roche Diagnostics
r To install the HbA1c test on c 502

modules
1
1 Download the application settings for the following
tests:
• Hemoglobin (HB-W3)
• Hemoglobin A1c (HbA1c) (A1-W3)
• Ratio % HbA1c (acc. to DCCT/NGSP) (RWD3)
• Hemolyzing reagent (A1CD2)
2 For the RWD3 whole blood application, in Utility

2
> Application > Range, clear the Automatic Rerun check
box.
3
3 In Calibration > Install > Download, download the
required calibrator data recommended in the
4
4 In QC > Install > Download, download the QC material
data according to the Instructions for Use.
11 Configuration
5
5 In Utility > Application > Range, define the decimal
places for the test result report of the calculated test
RWD3.
I We recommend reporting the results to an accuracy
of 1 decimal.
Roche Diagnostics
6 To report results, define a calculated test:

• To report results according to DCCT/NGSP
standardization, in Utility > Application > Formula,
enter RWD3 as calculated test.
• To report results according to IFCC standardization,
program a test on the data manager under Test
configuration > Test / reference ranges.
I Refer to the Operator’s Manual of the data
manager.
7
7 To assign the RWD3 test to a module, choose Utility
> System Configuration > Test Assignment > c502.
8
8 To assign the RWD3 test to a test key on the Suprnt tab
(supernatant), choose Utility > System > Key Settings
> Profile Setting.
9
9 To assign a rack range, do the following:
• Choose Utility > System > Rack Assignment.
• Choose the tab corresponding to the used sample
tubes.
• In the Suprnt field, enter the rack range.
I For the Sarstedt Monovette 2.7 mL tubes, the rack
range must be defined for non-standard tubes.
10 For Sarstedt Monovette 2.7 mL tubes, prepare the

racks:
• From the rack, remove the rack rubber disks.
11 Configuration
• To align the tubes vertically, use cup adapters.
Roche Diagnostics
11
11 Load the reagent cassettes for the following
applications:
• A1C-3: Hemoglobin (HB-W3) / HbA1c (A1-W3)
• A1CD2: Hemolyzing reagent
12
12 In Utility > Special Wash > Sample Probe > Edit and/or
Utility > Special Wash > Cell > Edit, program special
A washes for the sample probe and/or the reaction cells
as stated in the special wash list.
B I The special wash list is available in the cobas®
e-library.
13 Perform calibration and QC measurements for the

C following tests:
• HB-W3
• A1-W3
A Special wash before C Special wash for the

sampling reaction cell that
contained the
hemolyzed sample and
HbA1c reagent
B Special wash after D Special wash for the
sampling whole blood predilution reaction
cell that contained
hemolyzed whole
blood
11 Configuration
Roche Diagnostics
u Related topics
• Installing data:
- Installing calibrator data from the data
manager (488)
- Installing QC material data from the data
manager (531)
• Defining settings:
- Defining automatic rerun tests (739)
- Defining decimal places (737)
• About formula parameters on cobas c, ISE and e 602
modules (750)
• Operator’s Manual or the online help of the data
manager
• Assigning sample racks:
- Assigning sample racks for standard
containers (675)
- Assigning sample racks for non-standard
tubes (676)
• Assigning tests:
- Assigning tests to the ISE module (762)
- Assigning tests and test profiles to test keys (682)
• Configuring a special wash:
- Configuring a reaction cell wash for cobas c
modules (755)
- Configuring a sample probe wash for cobas c
modules (757)
- Configuring special washes for cobas c
modules (753)
11 Configuration
Roche Diagnostics
Installing the serum index application on cobas c modules

To ensure accurate measurement of samples, you can
install serum index values for lipemia (L), hemolysis (H), and
icterus (I).
Serum index values Lipemia, hemolysis, and icterus can interfere with the
measurement of samples. The serum index values are used
to indicate any interference.
Serum index value Meaning Measurement interference

L Lipemic index Turbidity
H Hemolysis index Concentration of hemoglobin
I Icterus index Estimated concentration of total bilirubin
y Serum index values
In Utility > Application > Chemistry > L, H, or I, you can enter

only one set of factors in the A to F fields for the serum
index values. The factors for the serum index values are
identical for lipemia, hemolysis, and icterus.
The recommended factors for the serum index values for

c 701 or c 702 modules are different from the
recommended factors for c 502 modules. For this reason,
the serum index application can either be run on c 701 and
c 702 modules, or on c 502 modules.
q You can also install a STAT serum index application

(3 min).
u Measurement of serum indices (1938)
Serum index value limits
Each photometric test has specific interference limits. On

Application > Range > Serum Index Check Value, you set the
interference limits for the serum index values in the L, H,
and I fields.
If a serum index value is outside the application-specific

11 Configuration
serum index value limit, there is a problem with the sample

and a data alarm is issued.
In all application settings, the serum index value limits for L,

H, and I are implemented in conventional measurement
units.
Roche Diagnostics
If you use the international measurement units for the H

and I serum index values, you must recalculate and change
the respective serum index value limits in all applications.
For recalculating, you must use the following conversion
factors:
• Serum index value H:
Limit H (international measurement units) = Limit H
(conventional measurement units) x 0.621
• Serum index value I:
Limit I (international measurement units) = Limit I
(conventional measurement units) x 17.1
r To install the serum index application

on cobas c modules
1
1 In Utility > Application > Download, download the
application settings for the serum index application SI2.
2 Choose Utility > Application > Chemistry.
3
3 From the left list, choose the L option.
11 Configuration
Roche Diagnostics
4
4 From the Test drop-down list, choose the SI2 option.
f The serum index applications L, H, and I are linked to
the SI2 reagent.
5
5 In the A to F fields, enter the factors for the serum index
values.
I For the recommended factor values, refer to the
Instructions for Use for the SI2 reagent.
The factor values recommended for c 701 and
c 702 modules are different from the factor values
recommended for c 502 modules.
The factors are identical for L, H, and I.
6
6 To configure the qualitative result reporting, select the
Qualitative check box.
8
8 In Utility > System Configuration > Test Assignment,
assign the serum index application to a module.
9
9 In Utility > System > Key Settings, assign the S.IND test
to a test key.
I Do not choose the SI2 test for the key setting.
11 Configuration
10 For the SI2 test, perform a blank calibration.
u Related topics
• Assigning tests to cobas c modules (763)
• Assigning tests and test profiles to test keys (682)
Roche Diagnostics
Defining application settings 731
Defining application settings

For each application, the system requires application
settings, calibrator data, and QC material data. In Utility
> Application, you can add new applications and configure
specific application settings.
In this section
Configuring analyze parameters (731)
Configuring calibration parameters (733)
Configuring range parameters (737)
About other parameters on cobas c and ISE modules (749)
About formula parameters on cobas c, ISE and e 602
modules (750)
Configuring analyze parameters

To suit individual laboratory practice, you can change
some of the parameters that have been preset with an
application.
q Changing an application setting may affect the

validity of results.
Check the new settings before using them.
If you choose Utility > Application > Analyze, the set

sampling parameters are displayed. You can check the
settings or configure new parameters.
Depending on the selected test and module, the screen

displays different analyze parameters.
In this section
Defining dilution factors for cobas e modules (731)
11 Configuration
Defining dilution factors for cobas e modules

For each test, you can define the dilution factor for the
first measurement and for rerun test measurements.
You must define the dilution factor for the first test
measurement only if high concentrations can be expected
in advance, for example, samples of tumor patients.
The dilution factor set by default is 1. If you choose, for

example, the dilution factor 2 in the list box, the sample is
diluted with the factor 1:2.
Roche Diagnostics
732 Defining application settings

r To define dilution factors for cobas e

modules
1
1 Choose Utility > Application > Immune > Analyze.
2
3
3 In the Default Dilution Ratio group box, choose the
dilution according to the Instructions for Use:
• From the For 1st drop-down list, choose the dilution
factor for the first test.
• From the For Rerun drop-down list, choose the
11 Configuration
dilution factor for rerun tests.
Roche Diagnostics
Configuring calibration parameters

some of the parameters that have been preset with an
application.

If you choose Utility > Application > Calib., the set

calibration parameters are displayed. You can check the

displays different calibration parameters.
u Setting calibration auto-masking (495)
In this section
Configuring automatic calibration (733)
Defining the duplicate limit for the e 602 module (735)
Configuring automatic calibration

Depending on the configuration, calibration is
recommended automatically. For each test, you can define
changeover and/or timeout parameters for recommended
calibration.

m For immunology tests: You must be familiar with the
Instructions for Use (available on the e-library).
11 Configuration
Roche Diagnostics
r To define recommended calibration

after timeout
1
2
11 Configuration
Roche Diagnostics
3
3 In the Preference Calibration Settings group box,
A configure the timeout parameters:
• For ISE modules:
From the Timeout drop-down list, choose the
calibration method and enter the value for the
timeout.
B
• For cobas c modules:
From the Lot drop-down list and/or from the R.Pack
drop-down list, choose the calibration method and
enter the value for the timeout.
• For cobas e modules:
Select the Reagent Pack Stability check box and/or
C the Lot Stability check box and enter the value for
the timeout.
• For e 801 modules:
Choose the QC violation option to turn off timeout
settings on the control unit.
If you set the QC violation settings on the data
manager, the data manager recommends
calibration when QC results are outside the limits.
A Preference calibration C Preference calibration

settings of the ISE settings of the cobas e
module module
B Preference calibration
settings of the cobas c
module
Defining the duplicate limit for the e 602 module

Calibrators are run in duplicate. To check the result of
duplicated calibration, you define the maximum tolerated
difference between the first and the second measurement
(duplicate limit) for each test.
If duplicate calibration results are outside the duplicate

limit, an alarm is issued and the calibration is flagged as
11 Configuration
unsuccessful.
q For the e 801 module, the duplicate limit is set in the

application and cannot be changed.

Roche Diagnostics
r To define the duplicate limit value for

e 602 modules
1
2
3
3 In the Duplicate Limit field, enter the duplicate limit
value.
I The duplicate limit value is from 0 through 64 %.
u Related topics
11 Configuration
• Duplicate error (1209)
Roche Diagnostics
Configuring range parameters

some of the parameters which have been preset with an
application.

If you choose Utility > Application > Range, the range

parameters are displayed. Range parameters are, for
example, application code, control intervals, technical
limit, and repeat limit for each test. You can check the

displays different range parameters.
In this section
Defining decimal places (737)
Defining automatic rerun tests (739)
Configuring automatic QC (740)
About technical limits (743)
Defining technical limits for tests on the ISE module (744)
Defining the repeat limit (745)
Configuring qualitative result reporting for cobas c
modules (747)
Configuring qualitative evaluation of quantitative tests for
e 602 modules (748)
Defining decimal places

For each clinical chemistry test, you can define the number
of digits (0-3) after the decimal point.
11 Configuration
For immunology tests, the number of decimal places is

fixed and depends on the level of the test result:
On the e 602 module up to three digits can be used after

the decimal point, for example, 0.123, 12.34, 123.4, or
1234.
On the e 801 module up to six digits can be used after the

decimal point, for example, 0.000123, 0.00123, 0.0123,
0.123, 1.23, 12.3, or 123.

Roche Diagnostics
r To define the number of decimal

places
1
1 Choose Utility > Application > Chemistry > Range.
2
3
3 In the Decimal Places field, enter the number of digits.

f The results are reported with the defined number of
decimal places.
q A new calibration is not required.

11 Configuration
Roche Diagnostics
Defining automatic rerun tests

You can define an automatic rerun for each test. If a data
alarm is attached to a test result and the Automatic Rerun
check box is selected, the sample remains on the module
sample buffer until the results of the sample are available.
Embedded tests on e 801 module
If you choose an embedded test, the Embedded Test check

box is automatically selected. In this case, you cannot
select the Automatic Rerun check box.
cobas e flow tests on e 801 module If you choose a linked test, the Embedded Test check box is
automatically selected. In this case, you cannot select the
Automatic Rerun check box.
If you choose a linked test, the Linked Test list is

automatically displayed showing the involved tests.

r To define automatic rerun tests
1
11 Configuration
Roche Diagnostics
2
3
3 Select the Automatic Rerun check box.
6
6 In the Automatic Rerun group box, choose the Change
button.
7
7 In the Automatic Rerun dialog box, select the Routine
and the Stat check box.
u Related topics
11 Configuration
Configuring automatic QC
For each test, you can configure that a QC is performed
automatically in set time intervals.
For the QC material used, you can define a time period for
the onboard stability. If the onboard stability expires, the
QC material cannot be used anymore.
Roche Diagnostics

r To configure automatic QC
1
2
3
3 Select the Control Interval check box.
4 In the Control Interval field, enter the time interval.

I The time interval can be set from 1 to 1000 hours.

11 Configuration
6
6 Choose Utility > System > Rack Assignment > Module
Settings.
Roche Diagnostics
7
7 To assign QC racks for automatic QC, enter the rack IDs
in the Auto. QC field.

f At the end of the time interval, QC is automatically
recommended.
f If auto QC racks with suitable QC material are
located in the auto QC compartment, QC is
automatically performed with the active (in use)
reagent cassettes.
r To define the onboard stability
1
2
11 Configuration
3
3 Select the Auto. QC On Board Stability Time check box.
4 In the Auto. QC On Board Stability Time field, enter the

time interval.
I The time interval can be set from 1 to 99 hours.
f If the onboard stability is exceeded, the QC material
expires.
Roche Diagnostics

I If auto QC racks are used and the QC material
expires, a yellow alarm is displayed. The QC material
cannot be used anymore. In QC > Status
> Unloading, a red bar indicates the expired QC
material.
u Related topics
• Assigning QC racks for automatic QC (681)
• Unloading auto QC racks from the auto QC
compartment (537)
About technical limits

A lower and upper technical limit is set for each test. Within
the technical limits, the measured signal corresponds to a
defined analyte concentration.
If results are outside the technical limits, an automatic

rerun test can be the consequence. Whether an automatic
rerun test is performed or not, depends on the result and
the module.
Result > technical limit Result < technical limit

(>Test data alarm) (<Test data alarm)
Photometric tests Automatic rerun test with decreased Automatic rerun test with increased
volume is possible. volume is possible.
Immunology tests Automatic rerun test with decreased No automatic rerun test is possible.
volume is possible.(1)
(2)ISE tests For serum/plasma samples: Automatic For serum/plasma samples: Automatic
rerun test with normal volume (15 µL) is rerun test with normal volume (15 µL) is
possible. possible.
However, in most cases it is appropriate
that you dilute the sample manually and
repeat the measurement.
y Consequences if a result is outside the technical limit
(1) The dilution factor defined on Utility > Application > Analyze is used.
(2) Technical limit is not used for urine samples.
11 Configuration
u Processing automatic rerun (597)

u Defining dilution factors for cobas e modules (731)
Photometric tests The technical limits are set for each photometric test and
must not be changed. The technical limits are included in
the application file and transferred from the data manager.
Immunology tests The technical limits are set for each immunology test,
although they are not displayed in the Range panel.
ISE tests To define technical limits for ISE tests with the sample type
serum/plasma, you must enter the technical limits in the
Technical Limit fields.
Roche Diagnostics
u Related topics
• Rerun test list (1228)
Defining technical limits for tests on the ISE module

For tests with the sample type serum/plasma, you must
enter the measuring range in the Technical Limit fields. For
tests with the sample type urine, the technical limit is not
required and not used as long as the default values are
displayed in the Technical Limit fields.
Sample type Measuring range Technical limits

Serum/plasma Na + 80–180 mmol/L Must be set within the measuring range.
K+ 1.5–10.0 mmol/L
Cl- 60–140 mmol/L

Urine Na+ 20–350 mmol/L(1) Not required. Not used as long as the default values
(-99999 and 999999) are entered.
K+ 3–100 mmol/L
Cl- 20–350 mmol/L(1)

Supernatant Not required
CSF Not required
y Measuring ranges and technical limits of tests on the ISE module
(1) From 20–60 mmol/L, only increased sample pipetting volume (15 µL) is effective.
If the result is outside the measuring range, the data alarm

< >Test (ISE sample range over) is attached.

r To define technical limits for ISE tests

11 Configuration
1
Roche Diagnostics
2
3
3 Define the technical limits:
• In the left Technical Limit field, enter the lower
technical limit.
• In the right Technical Limit field, enter the upper
technical limit.
Defining the repeat limit

A lower and upper repeat limit can be set for each test.
Within the repeat limits, a clinically relevant concentration
range is defined.
If the result is outside the repeat limit but inside the

technical limit, the test is repeated using the same sample
pipetting volume and dilution as in the first run. In Utility
> System > Alarm Settings, you can configure an automatic
rerun test.
u Processing automatic rerun (597)
11 Configuration

Roche Diagnostics
r To define the repeat limit
1
2
3
3 Define the repeat limits:
• In the left Repeat Limit field, enter the lower repeat
limit.
• In the right Repeat Limit field, enter the upper
repeat limit.
I For photometric tests, the repeat limits must be
within the technical limits.

11 Configuration
Roche Diagnostics
Configuring qualitative result reporting for cobas c modules

This function is important for drug abuse testing in
particular. For each photometric test, you can select
qualitative result reporting. You can set up to 5 upper limits
to define the measuring range.
In the fields of the left column (1 to 5), you enter the upper
limit of the measuring range.
In the fields of the right column (1 to 6), you enter the
characters to be printed on the report.
If the result is equal to or lower than the upper limit defined

in (1 to 5), the characters defined in the right column
(1 to 5) are printed in the report.
If the result is higher than the upper limit defined in (5), the
characters defined in the right column (6) are printed on
the report.

r To configure qualitative evaluation

for cobas c modules
1
2
11 Configuration
Roche Diagnostics
3
3 To activate qualitative evaluation, select the Qualitative
check box.
4 For all concentration ranges to be defined, set the

measuring range:
• In the left Qualitative field, enter the upper limit.
• In the right Qualitative field, enter the characters to
be printed on the report.
Configuring qualitative evaluation of quantitative tests for e 602 modules

This function applies only to quantitative infectious disease
tests, for example, anti-HBs. Based on the test result, an
additional result message indicates whether the result is
reactive, non-reactive, or in the border range. The fields
are visible for specific infectious disease assays, which are
available in the United States only.
The Cut Off Target field defines the reference value for this
test, while the Cut Off Limit fields define the lower and
upper limit for the border range.
Example: The Cut Off Target is set to 20 (concentration

units, e.g., IU/L), the lower Cut Off Limit is set to 10 (%), and
the upper Cut Off Limit is set to 10 (%.)
Cut off Result message

18–22 Border: Result in a gray zone. No
determination whether reactive or non-
reactive can be made.
< 18 NonReac is attached to the test result
> 22 Reac is attached to the test result
y Result messages attached in this example
q On e 801 modules, you can neither view nor change

these fields in the user interface. The result message is
reported as a numeric cut off index value (COI) to the data
11 Configuration
manager.

Roche Diagnostics
r To configure qualitative evaluation of

quantitative tests for e 602 modules
1
1 Choose Utility > Application > Immune > Range.
3
3 Enter the target concentration into the Cut Off Target
field.
• In the left Cut Off Limit field, enter the lower limit of
the border range.
• In the right Cut Off Limit field, enter the upper limit
of the border range.

f You can view the result message, for example, in the
R.M. column on Workplace > Data Review > Test
Review.
About other parameters on cobas c and ISE modules

application.

If you choose Utility > Application > Chemistry > Other,

additional calibrator information is displayed, for example,
calibrator code, sample (calibrator) volumes, diluent
11 Configuration
volumes, and diluted pipetting volumes.

displays different calibrator parameters.
If at least one rack position has been assigned to a

A Other parameters for tests on cobas c modules
calibrator, Assigned is displayed in the corresponding Rack
Assign field. In Calibration > Calibrators > Rack Assign, you
can assign multiple positions for one calibrator code.
Roche Diagnostics
About formula parameters on cobas c, ISE and e 602

modules
application.

If you choose Utility > Application > Formula, formulas

based on test results are displayed. You can check the
settings or configure new formulas to program
compensated tests.
A Formula parameters
Compensated tests A compensated test is a test whose result is modified by a

formula.
You can program compensated tests on the instrument or

on the data manager.
On the instrument, you program compensated tests on

Utility > Application > Formula.
11 Configuration
On the data manager, you program compensated tests on

Test Configuration > Test/reference ranges.
Calculated tests A calculated test is a test whose result is calculated from

different individual analytical methods with a given formula
such as ratio A/B.
You must program calculated tests on the data manager

on Test Configuration > Test/reference ranges.
The result calculated by the instrument is not displayed in

the data manager.
Roche Diagnostics
Defining special wash data 751
Defining special wash data

To avoid carryover between tests, you can install or
program special wash data for reagent probes, sample
probes, and reaction cells.
You can define combinations of reagents or samples that

can cause carryover. When one of these combinations is
encountered during a run, the special wash is performed.
In Utility > Special Wash > Download, you can download the
special wash data recommended for the installed
application from the data manager.
To ensure that for the installed applications, the
programmed special washes are correct and complete,
you must regularly use the download function.
In Utility > Special Wash > Reagent Probe, Cell, or Sample

Probe, in the Manufacturer Rule list, the downloaded
special wash data is displayed.
In Utility > Special Wash > Reagent Probe, Cell, or Sample

Probe, in the User Rule list, you can program further special
washes. If you have programmed special washes, they are
displayed in the User Rule list.
You must ensure that the programmed special washes for

the installed applications are correct and complete:
• To regularly download the current special wash data,
you must choose Overview > Parameter Download
> Special Wash > Download.
• In the cobas® e-library, you must observe the Carry over
evasion list.
q For the e 801 module, no special wash is needed and

the Special Wash submenu is not available. After each
reagent pipetting step, a reagent probe wash is performed
11 Configuration
automatically.
In this section
Downloading special wash data (752)
Configuring special washes for cobas c modules (753)
Configuring a reagent probe wash for the e 602
module (759)
Deleting special wash data for cobas c modules (761)
Roche Diagnostics
752 Defining special wash data
Downloading special wash data

When you install a new application, you must download all
necessary special wash data from cobas® link via the data
manager.

Administrators can download special wash data
regardless of the currently installed release.
Supervisors can only download the special wash data
of the newest and the current release for the same
wash type and module type.
r To download special wash data
1
1 Choose Utility > Special Wash > Download
2
2 To preselect the available special wash data, choose
one of the following Search Using options:
• To display a list of all special wash data, choose the
All Item option.
• To display a list of the necessary data, choose the
Required Item option.
• To display special wash data for a module type, for
example, c 701 module, choose the Module Type
option.
• To display special wash data released in the
relevant interval, choose the Release Date field.

f A list of items that meet the selected search criteria
is displayed in the Result list.
11 Configuration
4 In the Result list, select the special wash data to be

downloaded.
5 Choose the Download button and confirm.
u Related topics
Roche Diagnostics
Configuring special washes for cobas c modules

In this section
Configuring a reagent probe wash for cobas c
modules (753)
Configuring a reaction cell wash for cobas c modules (755)
Configuring a sample probe wash for cobas c
modules (757)
Configuring a reagent probe wash for cobas c modules
The reagent probes dip into the reagents when aspirating.

To avoid reagent carryover, you must download or
program a special wash for the reagent probe.
r To configure a reagent probe wash

for cobas c modules
1
1 Choose Utility > Special Wash > Reagent Probe.
2
2 From the Module Type drop-down list, choose the
corresponding cobas c module.
11 Configuration
3
3 From the User Rule list, choose a line:
• To add a new reagent probe wash, choose an empty
line.
• To edit an existing reagent probe wash, choose the
corresponding line.
Roche Diagnostics
5
5 To determine which reagent probe is washed, from the
Probe drop-down list, choose R1 or R2.
6
6 In the From Reagent column, do the following:
• From the Test drop-down list, choose the test that
can cause carryover.
• From the Type drop-down list, choose the reagent
type R1, R2, or R3.
7
7 In the To Reagent column, do the following:
• From the Test drop-down list, choose the test name
of the corresponding test.
• From the Type drop-down list, choose the reagent
type R1, R2, or R3.
8
8 In the Detergent column, do the following:
• From the Type drop-down list, choose the detergent
used for washing: D1=NaOHD, D2=SMS, D3=SCCS,
or water.
• In the Volume field, enter the wash solution volume
(20–180 µL).

f If the reagent probe wash is new, it is added to the
User Rule list.
f If the reagent probe wash exists, it is reconfigured.
10
10 To activate the new reagent probe wash, do the
following:
• Select the check box of the reagent probe wash.
11 Configuration
Roche Diagnostics
11
11 On Reagent > Status, check the amount of detergent
remaining on the instrument.
u Related topics
• Deleting special wash data for cobas c modules (761)
Configuring a reaction cell wash for cobas c modules

To avoid carryover of traces of the test mixture from one
test to the next test measured in the same reaction cell,
you can program a special wash for the reaction cell.
r To configure a reaction cell wash for

cobas c modules
1
1 Choose Utility > Special Wash > Cell.
2
11 Configuration
3
3 In the User Rule list, do the following:
• To add a new reaction cell wash, choose an empty
line.
• To edit an existing reaction cell wash, choose the
corresponding line.
Roche Diagnostics
5
5 From the Test drop-down list, choose a test that may
cause carryover.
I For the HbA1c test: On the Edit (Cell) dialog box, the
After Sampling group box is displayed. In the After
Sampling group box, you can define reaction cell
washes for reaction cells that are used for
predilution of HbA1c whole blood tests. If you
select the reaction cell wash, the reaction cell wash
is performed after the corresponding test.
6
6 In the R1 column, do the following:
used for washing (D1 = NaOHD, D2 = SMS,
D3 = SCCS, or water).
• In the Volume field, enter the detergent volume
(20-180 µL).
7
7 In the R2/3 column, do the following:
used for washing (D1 = NaOHD, D2 = SMS,
D3 = SCCS, or water).
• In the Volume field, enter the detergent volume
(20-180 µL).
9
9 To activate the new reaction cell wash, do the
following:
• Select the check box of the reaction cell wash.
10
u Related topics
• Installing the HbA1c test on the c 502 module (723)
11 Configuration
Roche Diagnostics
Configuring a sample probe wash for cobas c modules

The sample probes dip into the samples to aspirate sample
liquid. To avoid carryover of sample liquid to a test that is
sensitive to sample residue, you must program a special
wash for the sample probe.
r To configure a sample probe wash for

cobas c modules
1
1 Choose Utility > Special Wash > Sample Probe.
2
2 From the Sample Type drop-down list, choose the
corresponding sample type.
3
3 In the User Rule list do the following:
• To add a new sample probe wash, choose an empty
line.
• To edit an existing sample probe wash, choose the
corresponding line.
11 Configuration
5
5 From the Test drop-down list, select a test that is
sensitive to sample residue.
Roche Diagnostics
6
type.
7
7 From the Type drop-down list, choose the detergent
used for washing.
The following detergents are used for washing the
sample probe:
• SmpCln1
• SmpCln2
• SmpCln1 + SmpCln2
• Water
I The detergent aspiration volume is 60 µL.
9
9 To activate the new sample probe wash, do the
following:
• Select the check box of the sample probe wash.
10
10 On the instrument, check that the appropriate wash
solution is in the correct position.
11 Configuration
A B
A Position 1 = SmpCln1 (basic wash)

B Position 2 = SmpCln2 (acid wash)
Roche Diagnostics
11
u Related topics
Configuring a reagent probe wash for the e 602 module

When aspirating, the reagent probes dip into the reagents.
To avoid carryover of reagent to other tests, on an e 602
module, you must program a special wash for the reagent
probe. On the e 602 module, you can only configure a
special wash for reagent probes.
In the context of special washes on e 602 modules, the

term sample probe refers to the sample probe of a cobas c
module, not to the sample probe of an e 602 module.
Before pipetting the photometric test, the sample probe of
the c 701, c 702, or c 502 modules is washed with the
specified detergent if a test is requested on the e 602
module afterwards.
u Configuring a sample probe wash for cobas c
modules (757)
q If on a cobas c module, a sample has been processed

and a sample probe wash has been performed before an
e 602 test is performed, a “b” is displayed for this sample in
11 Configuration
the C.E. column on the Data Review submenu.
Roche Diagnostics
r To configure a reagent probe wash

for the e 602 module
1
1 Choose Utility > Special Wash > Reagent Probe.
2
2 From the Module Type drop-down list, choose the e 602
module.
3
3 From the User Rule list, choose a line:
• To add a new reagent probe wash, choose an empty
line.
• To edit an existing reagent probe wash, choose the
corresponding line.
5
5 In the From Reagent column, do the following:
• From the Test drop-down list, choose the test that
can cause carryover.
• From the Step drop-down list, choose step 0, 1,
or 2.
I Step 0: Pipetting step for pretreatment or diluent.
Step 1: Pipetting step before the first incubation.
Step 2: Pipetting step before the second
incubation.
6
6 In the To Reagent column, do the following:
• From the Test drop-down list, choose the test name
of the corresponding test.
11 Configuration
• To activate a reagent probe wash after a pipetting

step (0, 1, or 2), choose ON or OFF from the
corresponding Step drop-down lists.

f If the reagent probe wash is new, it is added to the
User Rule list.
f If the reagent probe wash exists, it is reconfigured.
8
8 To activate the new reagent probe wash, do the
following:
• Select the check box of the reagent probe wash.
Roche Diagnostics
u Related topics
Deleting special wash data for cobas c modules

After changing a reagent probe wash, reaction cell wash,
or sample probe wash, you can delete the preceding
special wash data.
r To delete special wash data for

cobas c modules
1 Choose Utility > Special Wash.
2
2 Depending on the special wash data to be deleted,
choose one of the following buttons:
• Reagent Probe
• Cell
• Sample Probe
3
4
4 From the User Rule list, choose the line that you want to
delete.
5 Choose the Delete button and confirm.

11 Configuration
Roche Diagnostics
762 Assigning tests to modules
Assigning tests to modules

On Utility > System Configuration, you can assign tests to a
specific module, power off a module, or configure a pre-
analytical system.
u Powering off a specific module completely (1235)
u Operating with a pre-analytical system (641)
q If you assign a test to a different module, you change

the test assignment. Afterwards, you must check all
application settings and set up the QC material data and
calibrator data.
In this section
Assigning tests to the ISE module (762)
Assigning tests to cobas c modules (763)
Assigning tests to cobas e modules (764)
Assigning tests to the ISE module

Before you perform a test on the ISE module, you must
assign the test to the ISE module.
r To assign tests to the ISE module
1
1 Choose Utility > System Configuration > Test
Assignment.
11 Configuration
2
2 Choose the ISE button.
Roche Diagnostics
Assigning tests to modules 763
3
3 In the Test Assignment (ISE) dialog box, choose one of
the following options:
• To allow sodium (Na+), potassium (K+), and chloride
(Cl-) ion testing on the ISE module, choose the Na, K,
Cl option.
• To allow only sodium (Na+) and potassium (K+)
testing on the ISE module, choose the Na, K option.
Assigning tests to cobas c modules

Before you perform a test on a cobas c module, you must
assign the test to the cobas c module.
r To assign tests to cobas c modules
1
Assignment.
2
2 Choose the button of the corresponding cobas c
module.
f The Test Assignment dialog box of the
corresponding cobas c module is displayed.
11 Configuration
Roche Diagnostics
3
3 From the Test list, choose a test.
4
4 If the reagent must be on board all the time, select the
Mandatory check box.
I If the reagent cassette of a mandatory test is not on
board, the corresponding reagent overview button
of the module is displayed in red on the Overview
menu. Nevertheless, operation of the module can
start.
f The Test list is updated immediately.
Mandatory tests are displayed with an asterisk.
5 To assign the test to reagent disk A, B, or both, select

the Reagent Disk A check box and/or the Reagent Disk B
check box.
Unassigned tests are unavailable.
Tests assigned on a c 701 or c 702 module to
reagent disk A, B or both are displayed with an A, B
or AB.

11 Configuration
Assigning tests to cobas e modules

Before you perform a test on a cobas e module, you must
assign the test to the cobas e module.
Roche Diagnostics
Assigning tests to modules 765
r To assign tests to cobas e modules
1
Assignment.
2
2 Choose the button of the corresponding cobas e
module.
f The Test Assignment dialog box of the
corresponding cobas e module is displayed.
3
3 From the Test list, choose a test.
I For the e 801 module: If the selected test is part of
a linked test or a linked kit, the Linked Test group
box displays information about the linked
application.
4
4 If the reagent must be on board all the time, select the
Mandatory check box.
I If the reagent cassette of a mandatory test is not on
board, the corresponding reagent overview button
of the module is displayed in red on the Overview
menu. Nevertheless, operation of the module can
11 Configuration
start.
A test that is not assigned to any of the measuring
channels must not be loaded on the system.
Mandatory tests are displayed with an asterisk.
Roche Diagnostics
5
5 To assign the test to measuring channel 1, 2, or both,
select the Ch.1 check box and/or the Ch.2 check box.
Unassigned tests are unavailable.
Tests assigned to measuring channel 1, 2 or both
are displayed with a 1, 2 or B.

11 Configuration
Roche Diagnostics
Maintenance
12 Overview of maintenance ................................................................... 769

13 Maintenance of the core unit and the MSBs....................................... 821
14 Maintenance of the ISE module.......................................................... 839
15 Maintenance of the c 701 and c 702 modules................................... 895
16 Maintenance of the c 502 module...................................................... 973
17 Maintenance of the e 801 module ................................................... 1049
18 Maintenance of the e 602 module ................................................... 1103
Roche Diagnostics
769
Table of contents
Overview of maintenance 12
In this chapter 12
Maintenance definitions . . . . . . . . . . . . . . . . . . . . . . . . . 771
About performing maintenance . . . . . . . . . . . . . . . . . . . 773
About modes for maintenance. . . . . . . . . . . . . . . . . . . . 774
Masking a module for background maintenance . . 775
Unmasking a module . . . . . . . . . . . . . . . . . . . . . . . . . 777
Performing parallel maintenance . . . . . . . . . . . . . . 778
Terminating software-controlled maintenance . . . 779
List of modes for maintenance . . . . . . . . . . . . . . . . 780
Putting a module in manual cleaning (Maintenance
mode). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 783
Terminating manual cleaning (Maintenance mode) 784
About maintenance pipes and maintenance pipe
functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 786
Creating a maintenance pipe . . . . . . . . . . . . . . . . . . 787
Using the Power Up Pipe function . . . . . . . . . . . . . . 789
Using the Start Up Pipe function . . . . . . . . . . . . . . . 791
List of recommended maintenance pipes . . . . . . . 792
Creating a maintenance type . . . . . . . . . . . . . . . . . . . . . 795
Checking maintenance due time . . . . . . . . . . . . . . . . . . 798
12 Overview of maintenance
Checking maintenance status . . . . . . . . . . . . . . . . . . . . 799
Requesting a maintenance report . . . . . . . . . . . . . . . . . 800
List of maintenance actions . . . . . . . . . . . . . . . . . . . . . . 802
List of maintenance checks . . . . . . . . . . . . . . . . . . . . . . 807
List of maintenance schedules for all modules . . . . . . 811
List of cleaning solutions . . . . . . . . . . . . . . . . . . . . . . . . 815
List of spare parts and replacement intervals . . . . . . . 816
List of maintenance videos. . . . . . . . . . . . . . . . . . . . . . . 818
Roche Diagnostics
770
Table of contents
Roche Diagnostics
Maintenance definitions 771
Maintenance definitions
Maintenance is divided into software-controlled
maintenance and manual maintenance. Software-
controlled maintenance actions can be grouped using
maintenance types. Software-controlled maintenance
actions can be automated using maintenance pipes.
Manual maintenance Maintenance actions that require operator interaction (for

example, cleaning the reaction cell rinse nozzles).
Software-controlled maintenance Maintenance actions that are performed by the instrument

without further operator interaction.
A Maintenance types B Maintenance actions
Maintenance action A single software-controlled maintenance action.

Maintenance actions can be performed manually by
selecting them in the software of the instrument.
Maintenance actions can also be part of a maintenance
pipe.
Roche Diagnostics
772 Maintenance definitions
Maintenance type A set of maintenance actions and maintenance pipes

grouped according to certain functions (for example, daily
maintenance).
u Checking maintenance due time (798)
Maintenance pipe A group of maintenance actions that can be performed by

the instrument automatically without operator interaction.
Maintenance pipe function The ability of the instrument to start a maintenance pipe at
a particular time.
u Using the Start Up Pipe function (791)
Roche Diagnostics
About performing maintenance 773
About performing maintenance

You can perform maintenance at different time points
during a shift.
We recommend performing maintenance actions at the

following time points:
• Perform software-controlled maintenance at the
beginning of pre-routine operation.
• Perform manual maintenance before powering off.
• To power on and off the instrument, perform the
recommended maintenance pipes with maintenance
pipe functions.
Additionally, you can perform manual maintenance on a

single module, as part of background maintenance during
routine operation.
The following graph shows the possibilities for performing

maintenance:
Performing maintenance during a shift
Manual power-on Maintenance pipe
Pre-routine operation Automatic maintenance
Background maintenance
Routine operation
Manual maintenance
Manual power-off Maintenance pipe
u Related topics
• List of recommended maintenance pipes (792)
Roche Diagnostics
774 About modes for maintenance
About modes for maintenance

You must perform maintenance actions in the appropriate
mode. This mode can either apply to the whole instrument
or a single module. If you apply a mode to a module, only
the mode of this module is changed. The rest of the
instrument maintains its mode.
If the e 801 module remains in Standby mode for 3 hours,

the instrument changes to Maintenance mode for
30 seconds. The ECL flow path is supplied with deionized
water to avoid the drainage of the measuring cells. You
cannot start operation during this period. The instrument
repeats this procedure every 3 hours as long as the e 801
module remains in Standby mode.
Instrument modes
Standby mode Mode when the instrument or module
does not perform any measurement
activities.
Powered off Analytical modules and the control

unit are disconnected and the
power-off button is switched off.
However, power for cooling the
reagents and auto QC materials is
still supplied.
Module modes
Standby mode If a module is masked, the mode of
(module masked) this module changes to Standby
mode. You can then perform
maintenance on this module while
operation can be performed on

other modules (background
maintenance).
Maintenance mode The motors of the selected module

(manual cleaning) are switched off. You can then
manually move different parts of the
module, such as the pipetter probes,
for cleaning purposes.
In this section
Masking a module for background maintenance (775)
Unmasking a module (777)
Performing parallel maintenance (778)
Terminating software-controlled maintenance (779)
List of modes for maintenance (780)
Putting a module in manual cleaning (Maintenance
mode) (783)
Terminating manual cleaning (Maintenance mode) (784)
Roche Diagnostics
Masking a module for background maintenance

To perform maintenance on one module while the system is
operating, you can mask this module. A masked module is
unavailable for operation.
Each module can be masked and unmasked separately.

The instrument can be in Standby mode, but masking is also
possible during most operational and maintenance modes.
A module can be masked without the MSB. This way the
MSB can operate while the module is masked.
However, water and vacuum are supplied to the ISE module

by the first c 701 or c 702 module of the system.
Therefore, their operation or maintenance is limited by the
supply situation of water and vacuum. For this reason,
some maintenance actions cannot be performed on the
first analytical module while the ISE module is operating or
performing an ISE check.
The following maintenance actions are subject to this

limitation:
• Incubation water exchange
• Incubator bath cleaning
• Manual cleaning
• Change reaction cell
• Change photometer lamp
To perform these maintenance actions, you must mask the

ISE module together with the first analytical module.
Maintenance pipes cannot be performed as background
maintenance. You must perform all maintenance actions
individually.

u Maintenance or cleaning
Roche Diagnostics
r To mask a module for background

maintenance
2
3
3 Choose the Module Masking button.
4
4 Choose the modules to be masked.
f The module buttons toggle between Module Mask,
Service Mask, and Unmask. When a module is
masked, it is crossed out on the display.

f Before masking, the module completes any samples
assigned to it. Therefore, the masking process can
take a couple of minutes.
6
6 To make sure that the module is in Standby mode,
choose the Overview menu.
f During the masking process, a dotted gray cross is
displayed on the module button and the module
mode cannot be changed.
7 Perform the desired maintenance actions and

maintenance checks.
Roche Diagnostics
Unmasking a module
To continue operation after performing background
maintenance, you must unmask this module.

j m The module is in Standby mode.
r To unmask a module
1 If a maintenance action is performed on the desired

module, terminate the maintenance action or check.
I Pressing the Stop button would stop all functions in
all modules. To terminate the maintenance action or
check, choose the Cancel Maintenance button.
3
4 Choose the Module Masking button.

4
Roche Diagnostics
5
5 Choose the modules to be unmasked.
f The module buttons toggle between Module Mask,
Service Mask, and Unmask.

f The module automatically joins the mode of the
system after unmasking.
u Related topics
• Terminating software-controlled maintenance (779)
Performing parallel maintenance

To perform different maintenance actions on different
modules, you can use parallel maintenance.
Maintenance pipe functions cannot be performed as

parallel maintenance. You must perform all maintenance
actions individually.
You can terminate maintenance actions performed on a

specific module.
u Terminating software-controlled maintenance (779)
r To perform parallel maintenance

1
2
2 Select the desired maintenance action.
Roche Diagnostics
3
4
4 Select the desired module.
6 To perform another maintenance action on another

module, repeat steps 2 to 5.
u Related topics
• List of modes for maintenance (780)
Terminating software-controlled maintenance

If you want to terminate maintenance actions performed
on a specific module, you must use the following
procedure.
Not all maintenance actions can be stopped once started.
q Pressing the Stop button would stop all functions in all

modules. All pipetted samples would be lost and must be
reloaded.
To terminate the maintenance action or check, choose the
Cancel Maintenance button.
r To terminate maintenance actions or

checks
1
2
Roche Diagnostics
3
3 Choose the Cancel Maintenance button.
4
f The module returns to Standby mode.
List of modes for maintenance

The following tables indicate the instrument or module
mode in which the maintenance actions and checks can be
performed.
Abbreviations used in the following tables:
l This maintenance action can be performed

SB Standby mode
B Background maintenance (module is masked)
P Parallel maintenance on different modules

(instrument in Standby mode)
Maintenance action ISE module c 701, c 702 c 502 module e 801 module e 602 module
modules
SB B P SB B P SB B P SB B P SB B P
(1) Reset l l l l l l l l l l l l l l l
(2) Rack Reset
(3) Photometer Check l l l l l l
(4) Cell Blank Measurement l l l l l l
(5) Incubation Water Exchange l(1) l(1) l(1) l l(2) l(2) l l l
y Available instrument modes for maintenance actions
Roche Diagnostics
Maintenance action ISE module c 701, c 702 c 502 module e 801 module e 602 module
modules
(6) Air Purge l l l l l l l l l
(7) Wash Reaction Parts l l (3)
l (3) l l (3)
l(3)
(8) Reagent Prime l l l l l l l l l
(9) Cell Detergent Prime l l l l l l
(10) Incubator Bath Cleaning l l(2) l(2) l l
(11) Manual Cleaning l l(2) l(2) l l l l l l
(12) Change Reaction Cell l l(2) l(2)
(13) Change Photometer Lamp l l(2) l(2)
(14) Parameter Read/Write
(15) Test Count Write
(16) QC Timer Reset
(17) System Wash l l l l l l l l l
(18) Sample Probe Wash l l l l l l l
(19) Reagent Probe Wash l l l l l l
(20) Bead Mixer Rinse l l l l l l
(21) e602/e801 Reagent Wash l l l l l l
(22) Pipetter Air Purge l l l l l l
(23) Sipper Air Purge l l l l l l
(24) MC Preparation l l l l l l
(25) MC Exchange l l l l l l
(26) Liquid Flow Cleaning l l l l l l
(27) Inventory Update l l l l l l
(28) ISE System Wash l
(29) Pre-wash Sipper Rinse l l l l l l
(30) Pre-wash Sipper Air Purge l l l l l l
(31) Finalization l l l l l l
(32) Empty PC/CC Reservoir l l l l l l
(33) Initial Bead Mixing l l l
(34) Reagent Capping l l l
(35) AssayCup Discarding l l l l l l
(36) System Air Purge (e602/e801) l l l l l l
(37) System Prime (e602/e801) l l l l l l
y Available instrument modes for maintenance actions
(1) ISE support box only
(2) This maintenance action cannot be performed on the c 701/c 702 module closest to the ISE module while the ISE module is operating or
performing an ISE check.
(3) Except for the sample probes
Roche Diagnostics
Maintenance check ISE module c 701, c 702 c 502 module e 801 module e 602 module
modules
(1) Disk Check
(2) ISE Check l l(1) l(1)
(3) Mechanism Check l l l l l l l l l l l l l l l
(4) Probe Check l l l l l l
(5) ISE Probe Check l
(6) Sample Barcode Reader Check l l
(7) Reagent ID Reader Check l l l l l l l l l l l l
(8) R. Pack Loading Check l(2) l(2) l(2) l l l
(9) Cuvette Mixing l l l l l l
(10) Reagent Short Sensor Check l l l l l l
(11) Sample Pipetting Check l l l l l l
(12) Reagent Pipetting Check l l l l l l
(13) Cap Opener Check l l l l l l
(14) Bead Mixer Check l l l l l l
(15) Gripper Check l l l l l l
(16) Magazine Exchange Check l l l l l l
(17) Sipper Check l l l l l l
(18) Pre-wash Probe Check l l l l l l
(19) Pre-wash Gripper Check l l l l l l
(20) Sipper Gripper Check l l l
(21) Reagent Loader Check l l l
(22) Reagent Handling Check l l l
(25) Urgent Information
(26) Essential Information Upload
(27) Database Backup
(50) Program Update
y Available instrument modes for maintenance checks

(1) This maintenance action cannot be performed while the c 701/c 702 module closest to the ISE module is performing an incubation water
exchange, incubator bath cleaning, manual cleaning, change reaction cell, or change photometer lamp maintenance action.
(2) Not available on c 701 modules. Only available if the MSB and c 702 module are masked.
Roche Diagnostics
Putting a module in manual cleaning (Maintenance mode)

To move different parts manually for cleaning purposes,
without having to power off the instrument, you can put a
module in manual cleaning (Maintenance mode).
In manual cleaning (Maintenance mode), the motors of the

selected module are switched off.
The ISE and the first module cannot be selected at the

same time for manual cleaning (Maintenance mode).
The ISE module, the c 502 module, and the e 801 module
have an interlock cover. If you open the top cover, you can
move the probes for cleaning. You do not need to put
these modules into manual cleaning (Maintenance mode).
j m The complete instrument is in Standby mode.

m Or: The respective module is masked and in Standby
mode.
r To put a module in manual cleaning

(Maintenance mode)
1
2
2 Choose the (11) Manual Cleaning option.
4
4 Select the desired modules.
5 Clear the check boxes for the ISE module, c 502

module, and the e 801 module.

f The probes on the selected modules move to their
cleaning positions.
Roche Diagnostics
7
7 To check that the module is in manual cleaning
(Maintenance mode), choose the Maintenance Monitor
button.
Terminating manual cleaning (Maintenance mode)

To continue operation, you must terminate manual
cleaning (Maintenance mode) properly.
q Pressing the Stop button would stop all functions in all

modules. All pipetted samples would be lost and must be
reloaded.
o Choose the Cancel Maintenance button to terminate
manual cleaning (Maintenance mode).
o Choose the Stop button only if no other module is
operating or performing background maintenance.
r To terminate manual cleaning

(Maintenance mode)
1
2
3
Roche Diagnostics
4
5
6
8
10
10 On c 701 and c 702 modules, additionally perform a
reagent registration:
• Select the c 701 and the c 702 modules.
I Instead of starting the reagent registration
manually, you can include it in a maintenance pipe
together with the reset.
f An LLD and a foam detection are performed by the
reagent probes for each reagent. If foam is
detected in a reagent cassette, this reagent
cassette is masked and an alarm is issued.
Roche Diagnostics
786 About maintenance pipes and maintenance pipe functions
About maintenance pipes and maintenance

pipe functions
You can group maintenance actions into maintenance
pipes. The instrument can then perform all maintenance
actions in the maintenance pipe automatically without
operator intervention.
By default, there are no predefined maintenance pipes on

the instrument. However, we recommend using
maintenance pipes for automating instrument care.
Maintenance pipes can be executed in 2 different ways:

• Manually by the user
• Automatically with maintenance pipe functions
To perform a maintenance pipe manually, you must group

the maintenance pipe into a maintenance type first.
You can power off the instrument automatically after

completion of a maintenance pipe. However, if the
maintenance pipe is executed with a maintenance pipe
function, the instrument is not powered off.
A Maintenance type B Maintenance pipe

Maintenance pipe function The instrument is able to start a maintenance pipe at a

particular time using maintenance pipe functions. There
are 2 maintenance pipe functions:
• Power Up Pipe function: Starts the maintenance pipe at
power-up
• Start Up Pipe function: Starts the maintenance pipe
before start of analysis
q Do not mix maintenance pipes with maintenance pipe

functions, particularly since names of maintenance pipes
are freely definable.
Roche Diagnostics
About maintenance pipes and maintenance pipe functions 787
Example: Maintenance pipes and maintenance

pipe functions
You have created a maintenance pipe which contains

Maintenance pipe several maintenance actions. You have named the
maintenance pipe Daily pipe. This maintenance pipe can be
Daily pipe executed manually or automatically with a maintenance
• (6) Air Purge pipe function. To execute the maintenance pipe
• (5) Incubation Water Exchange
• (8) Reagent Prime
automatically, you can either use the maintenance pipe
• (3) Photometer Check function called Start Up Pipe or the maintenance pipe
function called Power Up Pipe. These names are fixed.
Automatic Manual In this section

Creating a maintenance pipe (787)
Power Up Pipe
function
Using the Power Up Pipe function (789)
Using the Start Up Pipe function (791)
Start Up Pipe
List of recommended maintenance pipes (792)
function
Creating a maintenance pipe

To let the instrument automatically perform a group of
maintenance actions, you can group maintenance actions
into a maintenance pipe.
You can create up to 20 maintenance pipes. Each

maintenance pipe can have up to 10 maintenance actions
including parameters belonging to them. The name of a
maintenance pipe is freely definable.
Maintenance actions in a maintenance pipe are performed
in the order in which they are listed in the maintenance
pipe.
r To create a maintenance pipe
1
1 Choose Utility > System > Pipe Settings.
Roche Diagnostics
2
2 Select the first blank line.
4
4 Enter a name for the new maintenance pipe.
5 To add a maintenance action to the maintenance pipe,

select the maintenance action and choose the Add
button.
6
6 To change the position of the maintenance action in the
maintenance pipe, select the maintenance action and
choose the appropriate Handing Order button.
7 If you want to select specific modules or create

parameters for the maintenance action, choose the
Parameter button.
8 Repeat steps 5 to 7 for all maintenance actions you

want to include in the maintenance pipe.
9
9 If you want to power off the instrument automatically
after completion of the maintenance pipe, select the
Power Off check box.
I If the maintenance pipe is executed with a
maintenance pipe function, the instrument is not
powered off.
Roche Diagnostics
10
10 If you want the instrument to execute washing with a
wash rack, select the Wash Rack check box.
I Before performing this maintenance pipe, you must
load the wash rack into the input buffer.
f The maintenance actions of this maintenance pipe
will be executed after the washing procedure.
11
11 If you want to register reagents on c 701/c 702
modules after the maintenance pipe, select the
Reagent Registration check box. The maintenance
action inventory update on e 602 modules is also
included.
I Reagent registration is necessary on c 701/c 702
modules, for example, after using manual cleaning
(Maintenance mode) or if you want to perform a
maintenance action that requires reagents.
12
12 If you want to include a maintenance action or
maintenance check at the end of the maintenance pipe,
select the corresponding check boxes.

f The maintenance pipe is displayed in the Pipe list.
u Related topics
Using the Power Up Pipe function
To let the instrument automatically perform a maintenance
pipe at power-up, you can use the Power Up Pipe function.
You can create a different maintenance pipe for each day

of the week. You can power on the instrument manually or
automatically by setting the time switch on the core unit. In
both cases, the maintenance pipe will be performed after
the initialization process.
Roche Diagnostics
r To use the Power Up Pipe function
1
1 Choose Utility > System > Pipe Settings.
2
2 Choose the Power Up Pipe button.
3
3 Set the maintenance pipe to be performed at power-up
for each day of the week:
• Select the check box for the desired day.
• Choose the maintenance pipe for the desired day.

f If you have set the time switch on the core unit to
power on the instrument automatically, the
analytical units are initialized 10 minutes before the
specified time. The maintenance pipe is performed
afterwards.
Roche Diagnostics
Using the Start Up Pipe function

To let the instrument automatically perform a maintenance
pipe before the start of analysis, you can use the Start Up
Pipe function.
r To use the Start Up Pipe function
2
2 Choose the Change button.
3
3 Choose the maintenance pipe to be performed before
the start of analysis.

f The chosen maintenance pipe is displayed in the
Start Up Pipe Setting group box. If no maintenance
pipe is selected, Cancel is displayed.
f The chosen maintenance pipe is performed.
Analysis starts automatically afterwards.
Roche Diagnostics
List of recommended maintenance pipes

We recommend using several maintenance pipes for
proper instrument care. However, there are no predefined
maintenance pipes on the instrument by default. For the
maintenance pipe to be performed correctly, you must
program the maintenance actions in the order listed below.
We also recommend using maintenance pipe functions to

perform maintenance pipes automatically. This action
ensures a maximum of instrument care with minimal
operator intervention.
u Using the Start Up Pipe function (791)
Daily maintenance pipe We recommend performing this maintenance pipe with the
Power Up Pipe function after initialization of the
instrument.

(6) Air Purge ALL option ISE, c 701, c 702
(5) Incubation Water Exchange c 701, c 702, c 502,
ISE support box
(8) Reagent Prime ALL option ISE
(3) Photometer Check c 701, c 702, c 502
y Recommended maintenance actions for the daily maintenance pipe
If a wash rack is processed in the daily maintenance pipe, it

is not necessary to perform a reagent prime. However, a
wash rack cannot be processed in a maintenance pipe if
that maintenance pipe uses the Power Up Pipe function or
Start Up Pipe function.
Although a maintenance pipe can be executed

automatically, some maintenance actions require visual
checks with the top cover closed.
u Checking the instrument performance (267)
u Powering on the instrument automatically (262)
Wash rack maintenance pipe If you process the wash rack at the end of analysis each
day, we recommend using a maintenance pipe with the
Power Off check box and the Wash Rack check box
selected. Load the wash rack before executing the
maintenance pipe. Perform a full calibration of all ISE tests
the next day.
Roche Diagnostics
Weekly maintenance pipe We recommend performing this maintenance pipe every

week before powering off or after startup.
q Before you power off the instrument, check the cell

blank measurement report (Print > Utility > Cell Blank
Measurement). The reaction cell blank values will be lost
after powering off.
u Washing the reaction parts of the c 701 and c 702
module (907)

(7) Wash Reaction Parts NaOHD reagent cassette c 701, c 702, c 502
required
(4) Cell Blank Measurement
(26) Essential Information Upload all modules
y Recommended maintenance actions for the weekly maintenance pipe
Finalization maintenance pipe If a run on the e 602 or e 801 module is interrupted, the
(after interruption of analysis) following maintenance pipe must be executed.

1 cycle
(31) Finalization Ch 1,2 option
(34) Reagent Capping e 602
y Recommended maintenance actions for the finalization maintenance pipe
Extended power-on 1
(after 24–64 hours powered off)
5 cycles
5 cycles
5 cycles
5 cycles
Extended power-on 2
(after 64 hours to 17 days powered off)
5 cycles
5 cycles
5 cycles
30 cycles
Roche Diagnostics
Extended power-off (for 64 hours to 17 days) We recommend performing this maintenance pipe with the
Power Off check box selected.

5 cycles
5 cycles
Roche Diagnostics
Creating a maintenance type 795
Creating a maintenance type

To group maintenance actions and maintenance pipes
according to certain functions (for example, daily
maintenance), you can use maintenance types.
Within a maintenance type, you can assign a period (due

time) and a warning level to each maintenance action and
maintenance pipe. The instrument then shows you when
you must perform a maintenance action or maintenance
pipe. Thus, you can create and customize a maintenance
schedule for every periodic maintenance action.
u Checking maintenance due time (798)
2 maintenance types are predefined:

• Maintenance: Contains all available software-
controlled maintenance actions except maintenance
checks and service routines.
• Check: Contains all maintenance checks.
A Predefined maintenance types
r To create a maintenance type
1
1 Choose Utility > System > Maintenance Settings.
Roche Diagnostics
796 Creating a maintenance type
2
2 Select the first blank line.
4
4 Enter a name for the new maintenance type.
5
5 Choose a maintenance action or maintenance pipe you
want to add to the maintenance type.
6
6 If you want to track the chosen maintenance action,
select the Period check box. Enter a period and choose
a period time (hours, days, month).
7
7 If you have entered a period, choose a timer:
• Realtime option: The actual time
• Power On option: Cumulative power-on time of the
instrument
• Operation option: Cumulative operation time
I You can check the power-on time and the operation
time in the maintenance report (Print > Utility
> Maintenance Report).
Roche Diagnostics
Creating a maintenance type 797
8
8 If you want a warning to be issued after a certain
percentage of your defined period has elapsed, select
the Warning Level check box. Enter a warning level.
I Example: You define a period of 10 hours in real
time and a warning level of 90%. The instrument will
remind you to perform the maintenance action or
maintenance pipe after 9 hours.
9
9 If you want to add a comment when executing the
maintenance action, select the Comment check box.
I The comment is printed in the maintenance report.
10
10 To add the maintenance action to the maintenance
type, choose the Update button.
f The maintenance action is displayed in the
Maintenance list on the left.
11 Repeat steps 5 to 10 for all maintenance actions you

want to include in the maintenance type.
Roche Diagnostics
798 Checking maintenance due time
Checking maintenance due time

The instrument can display the due time for a maintenance
action or maintenance pipe within a maintenance type.
The instrument only displays the due time if you assign a

period and a warning level to a maintenance action or
maintenance pipe within a maintenance type.
The instrument displays the due time for maintenance

types, maintenance actions, and maintenance pipes with
the following colors:
Color Meaning
Maintenance Type A maintenance action or maintenance
pipe of this maintenance type
exceeded its warning level.
A maintenance action or maintenance
pipe of this maintenance type
exceeded its maintenance interval.
Maintenance action/pipe This maintenance action or
maintenance pipe exceeded its
warning level.
This maintenance action or
maintenance pipe exceeded its
maintenance interval.
y Colors for maintenance due time
r To check maintenance due time

1
2 Check if any maintenance types are highlighted in

yellow or red.
3
3 Select a maintenance type.
4 Check if any maintenance actions are highlighted in

yellow or red:
• The Date/Time column displays when the
maintenance action or maintenance pipe was last
started.
• If the maintenance action or maintenance pipe is
due, the date is highlighted in yellow or red.
Roche Diagnostics
Checking maintenance status 799
Checking maintenance status

To check the status of the maintenance action currently
performed, you can use the Maintenance Monitor dialog
box.
The Maintenance Monitor dialog box displays the status of

the module on which the maintenance action is performed.
The dialog box also displays the remaining time for most
r To check the maintenance status
1
2
f The status of the current maintenance actions is
displayed.
Roche Diagnostics
800 Requesting a maintenance report
Requesting a maintenance report

To view the record of the execution of all maintenance
actions or a selected maintenance action, you can request
a maintenance report.
The maintenance report lists the date, time, operator ID,

and comments of the selected maintenance actions.
When a maintenance action is performed as part of a

maintenance pipe, an asterisk (*) appears on the left side
of the date in the maintenance report.
r To request a maintenance report
1
2
2 Select the maintenance type that contains the desired
maintenance action or checks.
3
3 If you want to request the maintenance report for a
specific maintenance action, select the respective
maintenance action.
4
4 Choose Print > Utility > Maintenance Report.
Roche Diagnostics
Requesting a maintenance report 801
5
5 Choose one of the following options:
• To print the maintenance report for all maintenance
actions of the selected maintenance type, choose
the All option.
• To print the maintenance report for only the
selected maintenance action, choose the Selected
option.
6 To print the maintenance report for only the modules

desired, select the respective check boxes.
7
7 Choose one of the following options:
• To print the maintenance report for all maintenance
actions performed, choose the All option.
• To print the maintenance report for only the last
maintenance actions performed, choose the Last
option.
• To print the maintenance report for a range of
dates, choose the Range option. In the Start field
and End field, type the first and last date and time of
the date range.
I You can define the date format in the Date format
drop-down list (Utility > System > Display Settings).
8 Choose the Preview button.

f The icon on the Print button starts flashing.
9
9 When the icon stops flashing, choose the History menu.
10 Check that the desired report is chosen.
11
11 Choose the Print Out button.
Roche Diagnostics
802 List of maintenance actions
List of maintenance actions

Maintenance actions are single software-controlled
maintenance actions. Some maintenance actions only
apply to particular modules.
The time required for a specific maintenance action

depends on the module configuration, the software
version, and the selected settings. For most maintenance
actions, the required time is displayed by the maintenance
status.

u Checking maintenance status (799)
(1) Reset Mechanical parts of the selected modules are reset to their
home positions.
(2) Rack Reset For core unit, MSB: Mechanical parts are reset to their
home positions. All racks including STAT racks are
transported to the output buffer. Auto QC racks and racks
in the MSB remain in the MSB unless the corresponding
check boxes are selected.
(3) Photometer Check For c 701, c 702, c 502 modules: Photometer output is
checked by measuring the cell blank value of reaction cell
no. 1.
(4) Cell Blank Measurement For c 701, c 702, c 502 modules: Cell blank values of all
reaction cells are measured. If there is a difference greater
than 0.1 absorbance units in the results for 1 reaction cell

compared to the reaction cell no. 1, it will be reported in
the list in the cell blank measurement report.
(5) Incubation Water Exchange For c 701, c 702, c 502 modules, ISE support box:
Incubation bath water is exchanged and ECO-D is added.
(6) Air Purge For ISE, c 701, c 702, c 502 modules: Any air is purged
which may have become trapped in the sample and
reagent syringes. Water as well as air are discharged at the
rinse stations.
(7) Wash Reaction Parts For c 701, c 702, c 502 modules: The reagent probes and
all reaction cells are washed with wash solution from an
NaOHD reagent cassette. With the Reagent Probe and Cell
check boxes selected, the NaOHD consumption is
approximately 63 mL per reagent disk on c 701/c 702
modules and 58 mL on c 502 modules.
If the remaining volume is below 70 mL on c 701/c 702

modules, load another NaOHD reagent cassette before
starting this maintenance action.
Roche Diagnostics
List of maintenance actions 803
(8) Reagent Prime For ISE module: Reagents are primed according to the
option chosen (default: ALL option, 20 cycles). Reagent
consumption 400 µL per cycle.
For e 801, e 602 modules: Pre-wash option: The flow path

from the PreClean aspiration tubing to the PreClean supply
nozzle and pre-wash sipper nozzle is primed. Reagent
option: The flow paths from the ProCell and CleanCell
aspiration pipes to the supply nozzles are primed. The
PC/CC cups are refilled. On e 801 modules, the flow path
from the CleanCell aspiration pipes to the reagent probes
rinse station is also primed.
(9) Cell Detergent Prime For c 701, c 702, c 502 modules: The aspiration tubings
for reaction cell wash solution (CellCln1 and CellCln2) are
primed. The aspiration tubings are purged of air and
reaction cells are filled up and emptied by vacuum. You can
select which wash solutions must be primed.
(10) Incubator Bath Cleaning For c 701, c 702, c 502 modules: The photometer lamp is
switched off and the incubation bath water is automatically
drained.
(11) Manual Cleaning For c 701, c 702, c 502, e 801, e 602 modules: In manual
cleaning (Maintenance mode), the motors of the selected
module are switched off. Use this maintenance action to
move different parts, for example, the pipetter probes,
manually for cleaning purposes, without having to power
off the instrument.
After manual cleaning (Maintenance mode), you must

perform a reagent registration for c 701/c 702 modules.
Instead of performing the reagent registration manually
(Reagent > Setting > Reagent Registration), you can include
it in a maintenance pipe.
(12) Change Reaction Cell For c 701, c 702, c 502 modules: The motor of the
reaction disk of the specified module is switched off and
the reaction disk can be moved freely. Use this
maintenance action to exchange reaction cells without
having to power off the instrument.
(13) Change Photometer Lamp For c 701, c 702, c 502 modules: The photometer lamp is
switched off. Use this maintenance action to exchange the
photometer lamp without having to power off the
instrument.
(14) Parameter Read/Write For control unit: The settings of the system parameters are
read from or written on a storage medium (DVD). The
system parameters can only be restored to the same
instrument.
(15) Test Count Write For core unit: Test count is written on a storage medium
(DVD). Note: Insert the storage medium into the drive
before you execute this maintenance action.
Roche Diagnostics
(16) QC Timer Reset For core unit: Resets the QC interval timer. For example,
the QC interval timer is set to 10 hours. When 5 hours are
left, you can reset the timer to 10 hours.
(17) System Wash For c 701, c 702 modules: All reaction cells and reagent
probes are washed with NaOHD from a reagent cassette.
The sample probes are washed with SmpCln1 (basic wash)
from the 20 mL bottle (approx. 300 µL).
For e 801, e 602 modules: Combination of maintenance

actions reagent probe wash, microbead mixer rinse,
pre-wash sipper rinse, and reagent wash. This combination
is performed as many times as specified.
(18) Sample Probe Wash For ISE, c 701, c 702, c 502 modules: The sample probes
are washed with SmpCln1 (basic wash) from the 20 mL
bottle (approx. 300 µL). Use this maintenance action if
there is a clogged probe.
(19) Reagent Probe Wash For e 801, e 602 modules: Both the inside and outside of
the reagent probe is washed with CleanCell M (e 801
module)/ProbeWash M (e 602 module) and deionized water
as many times as specified.
(20) Bead Mixer Rinse For e 801, e 602 modules: The microbead mixer is rinsed
with deionized water as many times as specified.
(21) e602/e801 Reagent Wash For e 801, e 602 modules: The ECL flow paths and the
PC/CC cups are rinsed and filled with deionized water.
(22) Pipetter Air Purge For e 801, e 602 modules: Sample pipetter and reagent
pipetter flow paths are purged of air as many times as
specified.
(23) Sipper Air Purge For e 801, e 602 modules: Sipper flow paths are purged of
air as many times as specified.
For e 801 modules: The ProCell flow path is purged of air
(24) MC Preparation For e 801, e 602 modules: Measuring cells are conditioned
(25) MC Exchange For e 801, e 602 modules: ECL flow paths are rinsed with
deionized water as many times as specified and then
emptied to be prepared for a measuring cell exchange.
Roche Diagnostics
List of maintenance actions 805
(26) Liquid Flow Cleaning For e 801 modules: With the Reservoir option, the ECL flow
paths in the detection unit are washed with SysClean
solution. With the PreWash option, the flow path of the
pre-wash sipper nozzle is washed with SysClean solution.
Liquid flow path cleaning must be performed after
10 000 measurements for each ECL flow path and after
20 000 measurements for the pre-wash flow path. The
instrument issues an alarm when one of the intervals is
exceeded. The control unit resets the test counter for
checking the liquid flow cleaning interval when you perform
liquid flow path cleaning.
For e 602 modules: The ECL flow paths are washed with
SysClean solution.
Liquid flow path cleaning must be performed at least once
every 2 weeks or after 2500–3000 tests per measuring
channel.
(27) Inventory Update For e 801, e 602 modules: The remaining amount of
ProbeWash solution is updated (e 602 module only). The
number of full and empty magazines is updated in the
software of the control unit. The number of AssayCups and
AssayTips is verified in the current magazine.
If the number is lower than expected by the software, the

AssayCups or AssayTips are discarded from the current
magazine. Then, a full magazine is lifted to the top. A
reagent RFID check (e 801 module)/reagent registration
(e 602 module) can be performed additionally.
(28) ISE System Wash For ISE module: The ISE flow path is washed with 200 mL
SysClean solution (10 mL SysClean solution diluted 1:20
with deionized water), which must be prepared in a
separate container.
(29) Pre-wash Sipper Rinse For e 801, e 602 modules: Pre-wash sipper flow path is
rinsed with deionized water as many times as specified.
(30) Pre-wash Sipper Air Purge For e 801, e 602 modules: Pre-wash sipper flow paths are
purged of air.
(31) Finalization For e 801 modules: Finalization routine is carried out on

sample pipetter, reagent pipetter, ECL sipper nozzles,
PreClean supply nozzle, pre-wash sipper nozzle, detection
unit, and system reagents. The module replaces system
reagents in the PC/CC cups and fills the measuring cells
For e 602 modules: Finalization routine is carried out on

sample pipetter, reagent pipetter, ECL sipper nozzles,
detection unit, and system reagents. The module replaces
system reagents in the PC/CC cups and fills the measuring
cells with deionized water.
(32) Empty PC/CC Reservoir For e 801, e 602 modules: PC/CC cups are drained.
Roche Diagnostics
(33) Initial Bead Mixing For e 602 module: Microbeads are mixed for 15 seconds in
all except the empty reagent cassettes.
(34) Reagent Capping For e 602 module: All open reagent cassettes are closed.
(35) AssayCup Discarding For e 801, e 602 modules: All AssayCups are removed
from the incubator disk, the vortex mixers, the separation
stations, and AssayCup holders and discarded. If
AssayCups remain on the module, for example, after an
E.Stop, you can use this maintenance action.
(36) System Air Purge (e602/e801) For e 801, e 602 modules: The following maintenance
actions are performed simultaneously:
• Pipetter air purge
• Sipper air purge
• Pre-wash sipper air purge
(37) System Prime (e602/e801) For e 801, e 602 modules: ProCell and CleanCell
aspiration pipes and the pre-wash aspiration tubings are
primed simultaneously.
Roche Diagnostics
List of maintenance checks 807
List of maintenance checks

With maintenance checks, you can test the functionality of
several hardware components. Some maintenance checks
only apply to particular modules.
(1) Disk Check For control unit: Files are checked on hard disk and a
directory listing is printed. If a malfunction occurs, the
system issues an alarm. The software version of the
instrument is listed at the end of the report.
(2) ISE Check The output of ISE electrodes (Na, K, Cl, and reference
electrodes) is measured with ISE Internal Standard
(30 cycles). A listing of the measured voltages is printed.
(3) Mechanism Check Performs a functional check of mechanical parts of the

selected modules.
(4) Probe Check For c 701, c 702, c 502 modules: Puts the module in probe
check mode. In this mode, the selected sample probe,
reagent probe, or reaction cell rinse units can be moved to
designated positions with a push button. For the c 701 and
c 702 modules, the push button is located behind the front
door. For the c 502 module, the push button is located
next to the EcoTergent pipetter and must only be operated
by users who have received training for the extended
maintenance actions that require the interlock release
tool.
(5) ISE Probe Check For ISE module: Puts the module in probe check mode. In
this mode, the sample probe can be moved to designated
positions with the Next button.
(6) Sample Barcode Reader Check For core unit, ISE, c 701, c 702, c 502, e 801, e 602
modules: Checks the sample barcode readers on the
modules by scanning a rack with barcoded samples. After
choosing the Stop button, the data is printed for
verification.
(7) Reagent ID Reader Check The reagent barcode reader or RFID readers are checked
according to the entered number of cycles.
For c 701 module: The performance of the RFID readers is

checked.
For c 702, c 502 modules: After starting the reagent id

reader check, a reagent cassette must be inserted in the
loading port. The RFID tag information (c 502 module:
barcode information) is read from the reagent cassette
label according to the input number of cycles. Finally the
reagent cassette is ejected and can be removed.
Roche Diagnostics
808 List of maintenance checks
For e 801 modules: The RFID tags on reagent cassettes

and the ProCell II M bottles are read. After starting the
reagent id reader check, 5 reagent cassettes must be
inserted in the reagent loader. The RFID tag information is
read from the reagent cassette label according to the
input number of cycles. Finally the reagent cassettes are
ejected and can be removed. To finish the check, press the
load button.
For e 602 modules: The barcodes of the loaded reagent

cassettes are scanned.
u For information on performing the reagent ID reader
check, see: Problem with a loading port due to RFID
reading errors on the e 801 module (1260)
(8) R. Pack Loading Check For c 702 module: The reagent cassette gripper and other
reagent cassette loading components are checked
according to the number of reagent cassettes loaded.
For c 502 module: The reagent cassette loading

mechanism is checked as well as the movement of the
reagent cassette gripper and reagent cassette piercer.
The check is performed according to the input number of
cycles (minimum: 5 cycles).
(9) Cuvette Mixing For c 701, c 702, c 502 modules: Performs a functional
check (10 cycles) on the ultrasonic mixers—optionally with
reaction cell wash.
The reagent probe pipettes deionized water into the

corresponding reaction cell for R1, R2, and R3 mixers.
Then the reaction cell turns to the mixing position and
ultrasonic mixing is executed. On c 701 and c 702
modules, the proper operation of the corresponding mixer

can be checked visually. The water in the reaction cell is
vibrating when the mixer is operating. On c 502 modules,
the visual check is not necessary.
(10) Reagent Short Sensor Check For e 801, e 602 modules: The sensors in the aspiration
pipes of the PreClean, ProCell, and CleanCell bottles are
checked.
(11) Sample Pipetting Check For e 801, e 602 modules: The movement of the sample
pipetter and its liquid level detection and clot detection
function are checked.
(12) Reagent Pipetting Check For e 801, e 602 modules: The movement of the reagent
pipetters is checked.
(13) Cap Opener Check For e 801, e 602 modules: The movement of the cap
opener is checked.
(14) Bead Mixer Check For e 801, e 602 modules: The movement of the microbead
mixer is checked.
Roche Diagnostics
List of maintenance checks 809
(15) Gripper Check For e 801, e 602 modules: The movement of the magazine
gripper and its AssayTip/AssayCup handling function are
checked.
(16) Magazine Exchange Check For e 801, e 602 modules: The movement of the magazine
lifter and magazine feeder are checked.
(17) Sipper Check For e 801, e 602 modules: The movement of the ECL
sipper nozzles and their liquid level detection function are
checked.
(18) Pre-wash Probe Check For e 801, e 602 modules: The movement and function of
the PreClean supply nozzle is checked. The PreClean
supply nozzle aspirates and discharges PreClean solution
during this procedure.
(19) Pre-wash Gripper Check For e 801, e 602 modules: The movement and the
AssayCup handling function of the pre-wash gripper are
checked.
(20) Sipper Gripper Check For e 801 module: The movement of the sipper gripper and
its AssayCup handling function are checked.
(21) Reagent Loader Check For e 801 module: The instrument checks the movement of
the reagent loader without moving reagent cassettes. The
sensors and RFID readers are checked.
u For information on performing this check, see: Problem
with the reagent loader on the e 801 module (1263)
(22) Reagent Handling Check For e 801 module: The instrument checks all components
used for reagent cassette handling.
u For information on performing this check, see: Problem
with the reagent cassette handling on the e 801
module (1264)
(25) Urgent Information This function initiates parameter synchronization between

the data manager and the control unit. New or updated
parameters for applications, calibrators, QC materials, and
special washes are then available in Overview > Parameter
Download. This function can only be performed in Standby
mode.
If you do not execute this maintenance check, the

parameters are only synchronized when you power on or
reboot the control unit.
Roche Diagnostics
810 List of maintenance checks
(26) Essential Information Upload This function saves the complete control unit database
including sample, calibrator, and QC material data as a
backup file to the data manager. The last 3 backups are
stored, the oldest backup is overwritten with the newest
backup. Hence, the last 3 backups are available to restore
to the instrument if necessary (for example, after a hard
disk failure).
This function can only be performed in Standby mode.
(27) Database Backup This function creates a GetLog file of the instrument
database and transfers it to the data manager. Select this
function in order to investigate instrument problems or
failures. This function can only be performed in Standby
mode.
The GetLog file must be exported to Roche by creating an

issue report from the data manager. Contact your Roche
(50) Program Update This function allows you to update the software of the
control unit via the data manager. Language versions
(including Online Help and alarm database) of the software
and maintenance videos for the Online Help can also be
installed using this function.
Roche Diagnostics
List of maintenance schedules for all modules 811
List of maintenance schedules for all

modules
Maintenance is required to ensure that the instrument
works properly and to keep the risk of contamination low.
You must observe the maintenance intervals listed in the
table.
The listed maintenance intervals are independent of the

operating time unless otherwise noted. That is, a few
maintenance intervals for the replacement of spare parts
are based on test count or operating time.
We recommend letting the software of the instrument

remind you of all periodic maintenance actions by
configuring maintenance types.
– This action is not performed or not available for this

module.
l This action is performed.

u Regular cleaning and maintenance
Roche Diagnostics
812 List of maintenance schedules for all modules
Daily
Procedure Core ISE c 701 c 702 c 502 e 801 e 602
Washing with the wash rack during continuous operation l l l l
Cleaning the sample probe of the ISE module l
Cleaning the drain ports of the ISE module l
Emptying and cleaning the concentrated liquid waste container l
Cleaning the pipetter probes l l l
Cleaning the reaction cell rinse nozzles l l l
Cleaning probes and nozzles l l
Emptying and cleaning the concentrated waste container l
y Daily maintenance actions
Weekly
Cleaning the rinse stations l l l l l
Washing the reaction parts l l l
Cleaning the cell covers l l l
Cleaning the discharge chute for reagent caps on the c 702 l
module
Checking the reagent cassette gripper on the c 702 module l
Cleaning ProCell/CleanCell supply nozzles and replacing l
PC/CC cups of the e 602 module
Cleaning the vortex mixers and separation stations of the e 602 l
module
Cleaning the incubator disk of the e 602 module l
Cleaning the microbead mixer of the e 602 module l
y Weekly maintenance actions
Every 2 weeks
Cleaning ProCell aspiration pipes of the e 801 module l

Cleaning ProCell/CleanCell supply nozzles and replacing l
Cleaning the vortex mixers and separation stations of the e 801 l
module
Cleaning the incubator disk of the e 801 module l
Cleaning the microbead mixer of the e 801 module l
Cleaning the rinse stations of the e 801 module l
Cleaning the ECL flow path of the e 602 module l
y Every 2 weeks maintenance actions
Roche Diagnostics
List of maintenance schedules for all modules 813
Monthly
Cleaning the water containers l
Checking the dilution vessel of the ISE module l
Cleaning the reagent aspiration filters of the ISE module l
Cleaning the ECO-D aspiration filter of the ISE support box l(1)
Replacing reaction cells and cleaning the incubation bath l l l
Replacing reaction cells and cleaning the incubation bath with l l l
the instrument powered off
Cleaning the aspiration filters l l l
Cleaning the filters behind the front doors l l l
y Monthly maintenance actions
Every 2 months
Replacing the Na, K and Cl electrodes l
y Every 2 months maintenance actions
Quarterly
Washing the ISE flow paths of the ISE module l
Replacing the pinch valve tubing of the ISE module l
Cleaning the ultrasonic mixers l l l
Cleaning the filter of the solenoid valve l l
Replacing the pinch valve tubing of the e 602 module l
y Quarterly maintenance actions
Every 6 months
Replacing the reference electrode l
Replacing the photometer lamp l l l
y Every 6 months maintenance actions
Roche Diagnostics
814 List of maintenance schedules for all modules
As required
Draining the degasser water trap container on the c 701 and l
c 702 modules
Draining the degasser water trap of the ISE support box l(1)
Draining the vacuum tank of the ISE support box l(1)
Cleaning the module surfaces l l l l l l l
Cleaning the dilution vessel of the ISE module l
Replacing the sample probe of the ISE module l
Eliminating clogging of the sample probe l
Eliminating clogging of the reaction cell rinse nozzles l l l
Replacing nozzle tips on reaction cell rinse nozzles l l l
Draining the vacuum tank l l l
Replacing the pipetter probes l l l
Eliminating clogging of pipetter probes l l l
Cleaning the cap waste box on the c 702 module l
Cleaning the reagent cassette gripper on the c 702 module l
Cleaning the ECL and pre-wash flow paths of the e 801 module l
Cleaning CleanCell aspiration pipes and bottle stand l
Cleaning PreClean aspiration pipes and bottle stands of the l
e 801 module
Checking and cleaning the magazine drawer of the e 801 module l
Cleaning ProCell/CleanCell aspiration pipes and bottle stand l
Cleaning the magazine drawer of the e 602 module l
Cleaning the reagent disk and reagent storage l
Cleaning racks l
Cleaning the rack tray l
Checking/cleaning the cooling unit filter of the e 801 module l
y As required maintenance actions
Roche Diagnostics
List of cleaning solutions 815
List of cleaning solutions

When cleaning or decontaminating the system, use the
recommended substances listed below.
Repeated use of alcohol or bleach on the instrument

surface may damage the surface finish. For this reason,
use alcohol and bleach only to clean up spills, but not for
regular cleaning.
For regular cleaning, such as cleaning the instrument

surface from dust, use deionized water only.
• Alcohol (e.g., isopropyl alcohol or ethanol)
- Recommended concentration: 70%
- Note: Alcohol solutions between 60 and 80% are
known to be rapidly antimicrobial against bacteria,
fungi, and viruses. Alcohol solutions with a
concentration below 50% or above 90% are not
suitable.
• 2% ECO-D solution
- ECO-D is supplied concentrated. You must dilute it
at a ratio of 1:50 to a 2% solution.
- Diluted ECO-D solutions are stable for 3 weeks.
• ISE Cleaning Solution/Elecsys SysClean solution
• Laboratory disinfectant
• Deionized water
• Tap water
• Bleach
q If local regulations prohibit the use of one of the
recommended cleaning solutions, use a comparable
cleaning solution that meets your local regulations.
Roche Diagnostics
816 List of spare parts and replacement intervals
List of spare parts and replacement

intervals
Some parts require periodic replacement for preventive
maintenance. Replacement is either based on given
intervals, on test count, or operating time.
Replace the listed parts regularly and in accordance with

your workload and the recommendations given in this
document.
q For proper instrument care, use only original spare

parts provided by Roche.
o The necessary spare parts are listed in the description
of the corresponding maintenance action.
o For ordering information, contact your local Roche
Sales representative or go to eLabDoc on the Roche
DiaLog website: dialog.roche.com.
Item Replacement interval

ISE module ISE electrodes (Cl, K, Na) o 2 months
o After measuring 9000 samples
ISE pinch valve tubing o 3 months
Reference electrode o 6 months
Sample probe o As required: if the sample probe is bent or otherwise
damaged
cobas c modules Reaction cells(1) o Monthly
Photometer lamp o 6 months
o If photometer check value exceeds 14 000 absorbance
units at any wavelength

o When used for more than 750 hours of power-on time.
To display when you must replace the photometer lamp,
you can assign a period and a warning level to the
maintenance action (3) Photometer Check with the
following settings:
o Period: 750 hours
o Timer: Power On
o Warning Level: 99 %
Sample and reagent probe o As required: if the sample probe is bent or otherwise
damaged
Nozzle tips o As required: if the corner or bottom of a nozzle tip is worn
so that water remains in the reaction cell
e 602 module Pinch valve tubing o 3 months, or
o After measuring 25 000 tests per measuring cell,
whichever comes first
y Replacement intervals of parts
(1) Storage temperature: 7-40 °C (44.6-104.0 °F). For details about the expiration date, refer to the product label.
Roche Diagnostics
List of spare parts and replacement intervals 817
To view the total test count per measuring channel, choose

Print > Utility > Cumulative Operation List. We recommend
that you note down the test counts when replacing spare
parts.
u Related topics
• List of maintenance schedules for all modules (811)
Roche Diagnostics
818 List of maintenance videos
List of maintenance videos

The online help system contains video clips that show you
how to perform specific maintenance actions.
The video clips are only available if the instrument is in

Standby mode.
The video clips are intended to complement the textual

description of the maintenance actions, but they cannot
replace the description.
– A video clip is not available for this maintenance

action.
l A video clip is available for this maintenance action.

Roche Diagnostics
List of maintenance videos 819
Maintenance action Core ISE c 701/c 702 e 801 e 602

Cleaning the water containers of the core unit and the MSBs l – – – –
Replacing the Na, K and Cl electrodes of the ISE module – l – – –
Replacing the reference electrode of the ISE module – l – – –
Cleaning the reaction cell covers of the c 701 and c 702 module – – l – –
Removing the reaction cells of the c 701 and c 702 modules – – l – –
Cleaning the incubation bath of the c 701 and c 702 modules – – l – –
Reinstalling the reaction cells of the c 701 and c 702 modules – – l – –
Replacing the photometer lamp of the c 701 and c 702 modules – – l – –
Replacing nozzle tips on reaction cell rinse nozzles of the c 701 and c 702 – – l – –
modules
Detaching a sample or reagent probe of the c 701 and c 702 modules – – l – –
Reattaching a sample or reagent probe of the c 701 and c 702 modules – – l – –
Eliminating clogging of pipetter probes of the c 701 and c 702 modules – – l – –
Cleaning ProCell/CleanCell supply nozzles and replacing PC/CC cups of – – – l –
the e 801 module
Cleaning the vortex mixers and separation stations of the e 801 module – – – l –
Cleaning the incubator disk of the e 801 module – – – l –
Cleaning the microbead mixer of the e 801 module – – – l –
Cleaning the rinse stations of the e 801 module – – – l –
Cleaning the ECL and pre-wash flow paths of the e 801 module – – – l –
Checking and cleaning the magazine drawer of the e 801 module – – – l –
Cleaning ProCell/CleanCell supply nozzles and replacing PC/CC cups of – – – – l
the e 602 module
Cleaning the vortex mixers and separation stations of the e 602 module – – – – l
Cleaning the incubator disk of the e 602 module – – – – l
Cleaning the microbead mixer of the e 602 module – – – – l
Cleaning the rinse stations of the e 602 module – – – – l
Cleaning the ECL flow path of the e 602 module – – – – l
Replacing the pinch valve tubing of the e 602 module – – – – l
Cleaning the reagent disk and reagent storage – – – – l
Cleaning the magazine drawer of the e 602 module – – – – l
y Maintenance actions with videos
Roche Diagnostics
820
12 Overview of maintenance List of maintenance videos
Roche Diagnostics
821
Table of contents
Maintenance of the core unit and

the MSBs 13
In this chapter 13
List of maintenance actions on the core unit and the
MSBs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 823
Daily maintenance of the core unit and the MSBs. . . . 824
Emptying and cleaning the concentrated waste
container of the core unit and the MSBs . . . . . . . . 824
Monthly maintenance of the core unit and the MSBs . 826
Cleaning the water containers of the core unit and
13 Maintenance of the core unit and the MSBs

the MSBs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 826
Maintenance as required on the core unit and the
MSBs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 832
Draining the degasser water trap container on the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . . . . 832
Cleaning the surface of the core unit . . . . . . . . . . . 833
Cleaning racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 834
Cleaning the rack tray . . . . . . . . . . . . . . . . . . . . . . . . 835
Roche Diagnostics
822
Table of contents
Roche Diagnostics
List of maintenance actions on the core unit and the MSBs 823
List of maintenance actions on the core

unit and the MSBs
table.

The following abbreviations are used:
PO Powered off
SB Standby mode
MM Module masked (Standby mode)
Interval Maintenance actions Instrument mode

Daily Emptying and cleaning the concentrated waste container of PO/SB/MM
the core unit and the MSBs (824)
Monthly Cleaning the water containers of the core unit and the PO
MSBs (826)
As needed Draining the degasser water trap container on the c 701 and PO
c 702 modules (832)
Cleaning the surface of the core unit (833) PO/SB
Cleaning racks (834) -
Cleaning the rack tray (835) -
y List of maintenance actions of the core unit and the module sample buffers
u Related topics
Roche Diagnostics
824 Daily maintenance of the core unit and the MSBs
Daily maintenance of the core unit and the

MSBs
You must perform the following maintenance actions every
day.
In this section
Emptying and cleaning the concentrated waste container
of the core unit and the MSBs (824)

of the core unit and the MSBs
If you dispose of highly concentrated waste, you must
empty each container at the end of each shift. If the
instrument is connected to a drainage system, no action is
required.
The concentrated waste containers are located at the rear

of the ISE module and each cobas c and cobas e module.
The instrument issues an alarm if you must empty a

concentrated waste container. To prevent disruption of
the daily routine, make sure that the containers are empty
at the beginning of a shift.
If necessary, clean the concentrated waste container.
q You can neutralize unpleasant odors emitted from the

concentrated waste of the cobas e 801 module using citric
acid, for example, 1 g citric acid monohydrate per 1 liter of
concentrated waste.

u Infectious waste
u Environmental harm
u Infection by an infectious instrument
n Approximately 1 minute
Roche Diagnostics
Daily maintenance of the core unit and the MSBs 825
d m Water
m Disinfectant
m Paper towels

m Or: The instrument is powered off.
r To empty and clean the concentrated

waste container
1
1 Lift the liquid level sensor assembly from the
concentrated waste container and place it on paper
towels.
2
2 Remove the water tubing from the concentrated waste
container and put paper towels under the water tubing.

3 Dispose of the contents of the concentrated waste
container according to your laboratory's biohazardous
waste disposal regulations.
4 Rinse the concentrated waste container thoroughly

AB C with water and dispose of the rinse water according to
A Concentrated liquid C Liquid level sensor your laboratory's biohazardous waste disposal
waste container assembly regulations.
B Tubing
5 Prepare the disinfectant according to the
manufacturer’s instructions. Pour it into the
concentrated waste container.
6 After a suitable time provided by the disinfectant

manufacturer’s product description dispose of the
disinfectant according to your laboratory’s
biohazardous waste disposal regulations.
7
7 Place the concentrated waste container back in its
original position.
8 Return the liquid level sensor assembly and the water

tubing to the concentrated waste container.
9 Dispose of the paper towels according to your

laboratory's biohazardous waste disposal regulations.
10 Disinfect the work area.
11 If the module is masked, unmask it.
Roche Diagnostics
826 Monthly maintenance of the core unit and the MSBs
Monthly maintenance of the core unit and

the MSBs
Perform these maintenance actions at least once a month.
In this section
Cleaning the water containers of the core unit and the
MSBs (826)
Cleaning the water containers of the core unit and the

MSBs
To prevent contamination of the entire flow path, you must
clean the black water containers.
The water containers are at the rear of each MSB.


u Fire and burns
u Spilled liquid
Videos • Disconnecting the water container

• Reconnecting the water container
n Approximately 8 minutes per module
d m Alcohol
m Deionized water
m Lint-free cloth
m Paper towels
m Gloves, arm-length

Roche Diagnostics
Monthly maintenance of the core unit and the MSBs 827
r To disconnect the water container
1
1 Turn off the external water supply.
I Depending on your laboratory setup, other
instruments might be connected to the same water
supply. Be careful not to accidentally cut off the
water supply to other instruments.
2 Remove the stopcock cover.

2

3
3 Close the stopcock at the outlet of the water container.
Roche Diagnostics
4
4 To absorb spilled water, place paper towels under the
tubing connector.
5 Turn the ring of the tubing connector until the markings

5
align (unlocked position).
A Unlocked position
6
6 Disconnect the tubing connector.
7
6
7 Lift the liquid level sensor assembly out of the water
container. Wait a moment to let water run out of the
tubings. Place the assembly on a number of paper
towels.
Roche Diagnostics
8
8 Wipe the liquid level sensor assembly thoroughly with
lint-free cloth moistened with alcohol.
9 Let the liquid level sensor assembly dry for 1 minute

and then wipe it with a lint-free cloth moistened with
deionized water.
10 Ensure that no lint remains on the liquid level sensor

assembly.
r To clean the water container
1
1 Pull off the assembly adapter from the water container
for easy access to the interior of the container.

2
2 Empty the water from the container.
3
3 Remove residual water by wiping the interior surface
with a dry lint-free cloth.
4 Clean the interior surface of the container and the

assembly adapter by wiping them thoroughly with a
lint-free cloth moistened with alcohol.
5 Let the container dry for 1 minute.
6 Rinse the container 3 times with deionized water.
Roche Diagnostics
r To reconnect the water container
1 Reattach the assembly adapter to the water container.
2 Fill the container at least 1/3 full with deionized water.
3
3 Put the liquid level sensor assembly back into the water
container.
4
4 NOTICE Instrument damages due to leaking water.
If the tubing connector of the water container is not
5 connected properly, water may leak out.
4 Reconnect and lock the tubing connector.
5 Open the water stopcock.
A Lock of the tubing connector
6 Return the stopcock cover.

6
Roche Diagnostics
7
Roche Diagnostics
832 Maintenance as required on the core unit and the MSBs
Maintenance as required on the core unit

and the MSBs
Perform these maintenance actions as required.
In this section
Draining the degasser water trap container on the c 701
Cleaning the surface of the core unit (833)
Cleaning racks (834)
Cleaning the rack tray (835)
Draining the degasser water trap container on the c 701

and c 702 modules
To ensure that the degasser performs effectively, the
connected water container of the MSB should be regularly

drained.
Drain the water when an alarm is issued.
n Approximately 1:30 minutes per MSB
d m 500 mL beaker

Roche Diagnostics
Maintenance as required on the core unit and the MSBs 833
r To drain the degasser water trap

container
1 Place a beaker beneath the outlet of the water

container tubing.
2
2 Turn the outlet cap counterclockwise and disconnect.
3 Drain the water into the beaker.
4 Reconnect the outlet cap and tighten it securely.
Cleaning the surface of the core unit

Spills on the analytical unit’s surface can be biohazardous.
Clean up all spills immediately.
Repeated use of alcohol or bleach on the surfaces of the

analyzer may damage the surface finish. For this reason,
use disinfectants containing alcohol or bleach only to
clean up potentially biohazardous spills, but not for regular
cleaning.
For regular cleaning, such as cleaning the surface from

dust, use deionized water only.

u Moving parts
operation
d m Disposable lint-free cloth or paper towels

m Laboratory disinfectant, alcohol, or bleach
m Deionized water
j m The instrument or module is in Standby mode

Roche Diagnostics
r To clean the module surface
1
1 Clean the surface using lint-free cloth or paper towels
moistened with deionized water or disinfectant.
I If necessary, move the movable parts manually to
clean the surface.
2 To avoid damages of the surface, remove residual

disinfectant by wiping the surface with a lint-free cloth
moistened with deionized water.
Cleaning racks
Spills or sample material on a rack can be hazardous. If a
rack is dirty, clean it.

d m 2% EcoTergent solution (1:50 dilution)

m Cotton swabs
m Lint-free cloth
j m The rack is removed from the instrument.
r To clean a rack
1
1 Wipe all surfaces of the rack with a lint-free cloth
moistened with a 2% EcoTergent solution.
I Take care when cleaning the barcode label on the
rack. Wipe the surface of the barcode label only
carefully.
When you clean the rack, make sure that you do not
damage the metal springs.
2 To clean areas of the rack that you cannot reach with

the lint-free cloth, use a cotton swab moistened with a
2% EcoTergent solution.
Roche Diagnostics
3 Wipe off the 2% EcoTergent solution from all surfaces

with a lint-free cloth moistened with deionized water or
a cotton swab moistened with deionized water.
4 Dry all surfaces of the rack with a lint-free cloth or a

cotton swab.
5
5 Visually check the rack:
• Make sure that there is no textile remaining on the
rack.
• Check whether the rack is damaged, for example,
missing rack rubber disks.
• Check whether the barcode label on the rack is
damaged or peeling off.
• If you find any damages, do not try to repair the rack
but replace it.
Cleaning the rack tray

Spills on the rack tray surface can be biohazardous. Clean
up all spills. The cleaning procedure described below is the
same for all types of rack trays.
! WARNING
Personal injury and infection due to edges on the
rack tray’s center guide rail.
The edges on the rack tray’s center guide rail may cause
personal injury and infection.
r Avoid contact with all edges, even when wearing lab
gloves.
r Wear protective equipment such as lab gloves.
r Carefully observe all instructions given in this task.

u Fire and burns
d m Lint-free cloth
m Cotton swab
m Alcohol
m Personal protective equipment such as lab gloves, lab
coat, and eye protection
j m The rack tray is removed from the instrument.
Roche Diagnostics
r To clean the rack trays
1
1 Use personal protective equipment when cleaning the
rack trays.
A B C D
A Rail edge C Rail center

B Rail groove D Rack tray
2
2 Wipe the rail center in both directions with a cotton
swab moistened with alcohol.
• If there is sticking and crystallized dirt on the rack

tray, scrape it with a cotton swab.
I Take care not to sustain injuries by coming into
contact with the edges.
3
3 Wipe the rail edge in both directions with a cotton swab
moistened with alcohol.
Roche Diagnostics
4
4 Wipe the rail groove in both directions with a cotton
5
5 Wipe the edges on the bottom of the rack tray in both
directions with a cotton swab moistened with alcohol.

6
6 Wipe the surface of the rack tray, starting from the
center in both directions with an at least 10 mm thick
pile of lint-free cloth moistened with alcohol.
• For rack tray shapes 1 and 2, hold the pile of lint-
free cloth with your fingers and wipe the surface of
the rack tray.
• For rack tray shapes 3 and 4, hold the rack tray with
one hand, the pile of lint-free cloth with your
fingers, and wipe the surface of the rack tray.
7
7 Wipe the rear surface of the rack tray, starting from the
center in both directions with an at least 10 mm thick
pile of lint-free cloth moistened with alcohol.
the rack tray.
Roche Diagnostics
8
8 Wipe the bottom surface of the rack tray, starting from
the center in both directions with an at least 10 mm
thick pile of lint-free cloth moistened with alcohol.
the rack tray.
9 Visually check the rack trays.

• Make sure that there is no textile remaining on the
rack tray.
• Make sure that there are no wet areas on the rack
tray.
Roche Diagnostics
839
Table of contents
Maintenance of the ISE module 14
In this chapter 14
List of maintenance actions on the ISE module. . . . . . 841
Daily maintenance of the ISE module . . . . . . . . . . . . . . 843
Washing with the wash rack during continuous
operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 843
Cleaning the sample probe of the ISE module . . . 847
Cleaning the drain ports of the ISE module . . . . . . 848
Emptying and cleaning the concentrated waste
container of the ISE module . . . . . . . . . . . . . . . . . . . 850
Weekly maintenance of the ISE module . . . . . . . . . . . . 852
Cleaning the rinse stations of the ISE module . . . . 852
Monthly maintenance of the ISE module . . . . . . . . . . . 855
Checking the dilution vessel of the ISE module. . . 855
Cleaning the reagent aspiration filters of the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 856
Cleaning the ECO-D aspiration filter of the
ISE support box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 860
Every 2 months maintenance of the ISE module . . . . . 862
14 Maintenance of the ISE module

Replacing the Na, K and Cl electrodes of the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 862
Quarterly maintenance of the ISE module . . . . . . . . . . 868
Washing the ISE flow paths . . . . . . . . . . . . . . . . . . . 868
Replacing the pinch valve tubing of the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 871
Every 6 months maintenance of the ISE module . . . . . 874
Replacing the reference electrode of the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 874
Maintenance as required on the ISE module . . . . . . . . 878
Cleaning the dilution vessel of the ISE module . . . 878
Replacing the sample probe of the ISE module . . 881
Detaching the sample probe of the ISE module 882
Reattaching the sample probe of the ISE
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 884
Checking the sample probe of the ISE module 886
Eliminating clogging of the sample probe . . . . . . . 888
Cleaning the surface of the ISE module . . . . . . . . . 890
Draining the degasser water trap of the
ISE support box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 891
Draining the vacuum tank of the ISE support box . 893
Roche Diagnostics
840
Table of contents
Roche Diagnostics
List of maintenance actions on the ISE module 841
List of maintenance actions on the ISE

module
Maintenance is required to ensure that the module works
properly and to keep the risk of contamination low. You
must observe the maintenance intervals listed in the table.

operating time unless otherwise noted.
The instrument mode column lists the required module

mode at the beginning of the maintenance action. That is,
the required module mode can change throughout a
maintenance action.

PO Powered off
SB Standby mode
MC Manual cleaning (Maintenance mode)

Interval Maintenance action Instrument mode
Daily Washing with the wash rack during continuous operation (843) SB(1)
Cleaning the sample probe of the ISE module (847) SB/MM/PO
Cleaning the drain ports of the ISE module (848) SB/MM/PO
Emptying and cleaning the concentrated waste container of PO or SB or MM
the ISE module (850)
Weekly Cleaning the rinse stations of the ISE module (852) MC/PO
Monthly Checking the dilution vessel of the ISE module (855) SB/MM/PO
Cleaning the reagent aspiration filters of the ISE module (856) SB/MM/PO
Cleaning the ECO-D aspiration filter of the SB/MM/PO
ISE support box (860)
Every 2 months(2) Replacing the Na, K and Cl electrodes of the ISE module (862) SB/MM/PO
Quarterly Washing the ISE flow paths (868) SB/MM
Replacing the pinch valve tubing of the ISE module (871) SB/MM/PO
Every 6 months Replacing the reference electrode of the ISE module (874) SB/MM/PO
y Maintenance actions – ISE module
Roche Diagnostics
842 List of maintenance actions on the ISE module

As required Cleaning the dilution vessel of the ISE module (878) SB/MM/PO
Replacing the sample probe of the ISE module (881) PO
Eliminating clogging of the sample probe (888) SB/MM/PO
Cleaning the surface of the ISE module (890) SB/MM/PO
Draining the degasser water trap of the ISE support box (891) SB/MM/PO
Draining the vacuum tank of the ISE support box (893) SB/MM/PO
y Maintenance actions – ISE module
(1) Or from any operational status such as Rack Reception or within a maintenance pipe.
(2) Or after measuring 9000 samples.
u Related topics
Roche Diagnostics
Daily maintenance of the ISE module 843
Daily maintenance of the ISE module

Perform these maintenance actions daily.
In this section
operation (843)
Cleaning the sample probe of the ISE module (847)
Cleaning the drain ports of the ISE module (848)
of the ISE module (850)
Washing with the wash rack during continuous operation

To prevent contamination of the entire flow path or the
sample probe, you must wash with the wash rack.

action for the ISE module and the c modules. The inner wall
of the sample probe and the liquid waste flow path are
cleaned as well as the ISE flow path, the ISE dilution vessel,
and the electrodes. After cleaning, the electrodes are
reconditioned with Activator.
Ways of processing the wash rack You can process the wash rack within a maintenance pipe
with the power-off function selected. This way, you save

time at the end of a day because the instrument is powered
off automatically after the completion of the maintenance
pipe.
You cannot process a wash rack within a maintenance pipe

with the Power Up Pipe function or Start Up Pipe function.
You can also process the wash rack prior to regular daily
calibration. A full calibration of the ISE tests is required
after the washing procedure.
Roche Diagnostics
844 Daily maintenance of the ISE module

operation. You can activate this function by selecting
Utility > System > Wash Racks.
• The instrument must not be in the Standby mode when
this function is activated.
• It is possible to load any other rack together with the
wash rack.
• During the washing procedure, ISE tests must be
masked (P.Mask). Only photometric and immunology
tests can be processed. Do not load any samples with
ISE requests. If you load samples with ISE requests, the
ISE requests cannot be processed until ISE tests are
unmasked again.
• Samples with open ISE requests that were registered
before masking the ISE tests are unloaded. You must
reload these samples after processing the wash rack.
u Powering off automatically with the wash rack (625)
operation (843)
Rack position System reagent Wash cycles ISE c 701/c 702 c 502
Only 300 µL are required for an ISE module with 1 ISE

measuring unit.
containers.
Example: c 702–c 502–c 502 combination:
volume of Sample Cup).
u Specifications of containers (2031) (dead volume)
Roche Diagnostics

u Infectious waste
u Moving parts
! WARNING
Incorrect results may occur due to shortage of ISE
system reagents
The conditioning and cleaning of the ISE units requires
sufficient volumes of Activator and SysClean solution.
r Fill sufficient volume of Activator and SysClean solution
into the cups.
r Place the cups into their correct positions on the wash
rack.
r If an alarm indicating an insufficient volume of Activator
or SysClean solution appears, rerun all ISE samples.

modules)
m SysClean
m Activator


Roche Diagnostics
1
1 Place sample tubes or cups into positions 1–3 on a
wash rack.
A 2 Pipette suitable amounts of the prescribed system

B reagents into the sample tubes.
C
I Take into account the dead volume of the used
containers.

as instructed.

r To perform washing with the wash

rack during operation
2
3 To mask the tests of the ISE module, do the following:

• Choose the cell corresponding to the test and the
ISE module. To switch to patient masking, choose
the corresponding cell repeatedly until P.Mask is
displayed.
4 Request a full calibration for all ISE tests.

results for ISE.
5 Place the racks in the following sequence into the input

buffer on the same rack tray: Wash rack, calibrator rack
containing the ISE calibrators, QC rack containing the
QC materials for ISE tests. To start the washing
procedure, choose Start > Start.
6 Check the results for calibration and QC.
7 If the analyzer has generated a valid calibration and the

QC results are good, unmask the ISE tests.
Roche Diagnostics
u Related topics
• Washing with the wash rack during continuous
operation (843)
• Masking tests for every measurement (578)
Cleaning the sample probe of the ISE module

To prevent build-up of residual solution and precipitation,
clean the outside of the sample probe.

u Moving parts
u Fire and burns
operation
d m Alcohol
m Lint-free cloth
m Paper towels

r To clean the outside of the probe
1
I The ISE module has an interlock cover that allows
the probe to be moved for cleaning when the top
cover is opened.
Roche Diagnostics
2
2 Cover the openings of the ISE dilution vessels with a
paper towel. Make sure no alcohol drips into the ISE
dilution vessels.
3 Move the sample probe by hand to an accessible

position.
4 Wipe the outside of the sample probe with a lint-free

cloth moistened with alcohol.
• Always wipe from top to bottom.
• Hold the pipetter arm with 1 hand and wipe with the
other.
I Do not place a lint-free cloth moistened with alcohol
on the module surface as the finish may be
damaged.
5 Remove the paper towel from the ISE dilution vessels.
6
6 Close the top cover.
7 If the module was masked, unmask it.
u Related topics
Cleaning the drain ports of the ISE module

To prevent the accumulation of crystals and clogging of
the drain ports, you must clean them. The liquid waste from
each ISE unit is drained through a separate drain port to
the concentrated liquid waste container. White crystals on
a drain port can reduce the electrode insulation and
therefore may lead to inaccurate test results.

u Infectious waste
u Moving parts
Roche Diagnostics
d m Lint-free cloth
m Deionized water

r To clean the outlets of the drain ports

for highly concentrated waste
1

2
2 Clean the drain ports and the bottom of the outlets with
deionized water.
A B
A Outlets B Drain ports
Roche Diagnostics
3
3 WARNING! Incorrect results due to opened front door
during analysis. Touching drain port components during
operation may cause noise and lead to inaccurate
measurement results. Do not touch the drain port
components during operation.
3 If any crystals are still present, remove the drain plates:
• Loosen the thumbscrews of the drain plates. To
remove all crystals, wipe the bottom of the drain
plates using a lint-free cloth moistened with
deionized water. Replace the drain plates.
4 Close the front door.
A B 5 If the module was masked, unmask it.

A Thumbscrews of drain plates
u Related topics
B Drain plate
• Replacing the sample probe of the ISE module (881)
• Checking the sample probe of the ISE module (886)

of the ISE module
If you dispose of highly concentrated waste, you must
empty each container at the end of each shift. If the
instrument is connected to a drainage system, no action is
required.
The concentrated waste containers are located at the rear

of the ISE module.
The instrument issues an alarm if you must empty a

concentrated waste container. To prevent disruption of
the daily routine, make sure that the containers are empty
at the beginning of a shift.
If necessary, clean the concentrated waste container.

u Infectious waste
u Moving parts
u Harmful fumes
Roche Diagnostics
d m Water
m Disinfectant
m Paper towels

r To empty and clean the concentrated

waste container
1
1 Lift the liquid level sensor assembly from the
concentrated waste container and place it on paper
towels.
2 2 Remove the water tubing from the concentrated waste

container and put paper towels under the water tubing.
3 Dispose of the contents of the concentrated waste

container according to your laboratory's biohazardous
waste disposal regulations.
4 Rinse the concentrated waste container thoroughly

AB C with water and dispose of the rinse water according to
A Concentrated liquid C Liquid level sensor your laboratory's biohazardous waste disposal

waste container assembly regulations.
B Tubing
5 Prepare the disinfectant according to the
manufacturer’s instructions. Pour it into the
concentrated waste container.
6 After a suitable time provided by the disinfectant

manufacturer’s product description dispose of the
disinfectant according to your laboratory’s
biohazardous waste disposal regulations.
7
7 Place the concentrated waste container back in its
original position.
8 Return the liquid level sensor assembly and the water

tubing to the concentrated waste container.
9 Dispose of the paper towels according to your

laboratory's biohazardous waste disposal regulations.
10 Disinfect the work area.
Roche Diagnostics
852 Weekly maintenance of the ISE module
Weekly maintenance of the ISE module

Perform these maintenance actions weekly.
In this section
Cleaning the rinse stations of the ISE module (852)
Cleaning the rinse stations of the ISE module

To prevent bacterial growth or precipitation that may clog
the rinse station, you must clean the rinse station of the
sample probe.

u Infectious waste
u Moving parts
u Fire and burns
u Spilled liquid
operation
d m Wash bottle
m Cotton swabs
m 2% ECO-D solution
m Deionized water
j m Instrument is in manual cleaning (Maintenance mode).

u Putting a module in manual cleaning (Maintenance
mode) (783)
Roche Diagnostics
Weekly maintenance of the ISE module 853
r To clean the rinse station
1
2
2 Move the sample probe to a position that leaves the
rinse station easily accessible.
3 Clean the inside of the rinse station using cotton swabs

moistened with 2% ECO-D solution.

A Rinse station
4
4 Inject about 10 mL of 2% ECO-D solution into the rinse
station.
I Immediately clean any ECO-D spills from the
surface.
5 Inject about 100 mL of deionized water into each rinse

station.
Roche Diagnostics
854 Weekly maintenance of the ISE module
6
u Related topics
Roche Diagnostics
Monthly maintenance of the ISE module 855
Monthly maintenance of the ISE module

Perform these maintenance actions monthly.
In this section
Checking the dilution vessel of the ISE module (855)
module (856)
Checking the dilution vessel of the ISE module

To avoid inaccurate test results due to contamination of
the ISE dilution vessel, you must check the ISE dilution
vessel for crystallization and contamination.

u Moving parts
operation

r To check the ISE dilution vessel
1
1 Remove the covers of the ISE units.
Roche Diagnostics
856 Monthly maintenance of the ISE module
2
2 Check the ISE dilution vessel. For a better view inside
C B the vessel, the vacuum nozzle and the ISE sipper nozzle
can be removed.
3 If crystallization or contamination are visible, perform

the cleaning procedure for the ISE dilution vessel.
4 Close the covers of the ISE units.
u Related topics
B C • Cleaning the dilution vessel of the ISE module (878)
A
A Dilution vessel
B Vacuum nozzle and retaining screw
C ISE sipper nozzle and retaining screw
Cleaning the reagent aspiration filters of the ISE module

To retain the efficiency of reagent aspiration and thus
result reliability, you must clean the reagent aspiration
filters of the ISE module.


u Moving parts

• System time: approximately 4 minutes for (8) Reagent
Prime
d m Deionized water
m Paper towels

Roche Diagnostics
r To clean the reagent aspiration filters

of the ISE module
1
2
2 Pull out the drawer with the reagent bottles.
3 Unscrew the bottle cap of the first reagent bottle.
4 Remove the tubing.
5
5 Unscrew the reagent aspiration filter from the end of
the tubing. 14 Maintenance of the ISE module
Roche Diagnostics
6
6 Clean and rinse the filter with deionized water.
7
7 Screw the filter onto the end of the tubing and place it
back into the bottle.
8 Replace the bottle.
9 Repeat steps 3 to 8 for each aspiration filter.
10 Push in the drawer and close the front door.
r To prime and calibrate the ISE module

1
1 To prevent blocking by the interlock function, make
sure that the top cover is locked.
2 By masking the module, make sure that the instrument

or the module is in Standby.
3
Roche Diagnostics
4
4 Choose the (8) Reagent Prime option.
6
6 Select the ISE module.
7 7 Choose ALL (or IS+DIL if only the ISE dilution vessel was
cleaned) from the drop-down list.
8 Enter “20” cycles.

f The prime is complete when the instrument returns
to Standby mode.
11 Calibrate the ISE module before processing routine

samples.
u Related topics

Roche Diagnostics

ISE support box
To retain the efficiency of ECO-D aspiration and thus result
reliability, you must clean the ECO-D aspiration filter of the
ISE support box.

u Moving parts

Prime
d m Deionized water
m Paper towels

r To clean the ECO-D aspiration filter

of the ISE support box
1
1 Open the front door of the ISE support box.
I The ECO-D bottle is stored in the drawer.
2 Unscrew the bottle cap of the ECO-D bottle.
3 Remove the tubing.
A ECO-D
Roche Diagnostics
4
4 Unscrew the ECO-D aspiration filter from the end of the
tubing.
5
5 Clean and rinse the filter with deionized water.
6 Finally, screw the filter on the tubing end and place it

back into the bottle.
7 Close the front door of the ISE support box.
u Related topics
Roche Diagnostics
862 Every 2 months maintenance of the ISE module

module
Perform these maintenance actions at least every
2 months.
In this section
Replacing the Na, K and Cl electrodes of the ISE
module (862)
Replacing the Na, K and Cl electrodes of the ISE module

To ensure the measurement accuracy of the ISE unit, you
must replace the ISE electrodes either every 2 months or
after 9000 tests, whichever occurs first.

u Moving parts
operation
Video Replacing the Na, K and Cl electrodes
n • Operator time: approximately 5 minutes, plus 2 minutes

for ISE calibration
Prime, approximately 14 minutes for (2) ISE Check,
approximately 8 minutes for ISE calibration
d m Sodium (Na+) electrode (yellow)

m Potassium (K+) electrode (red)
m Chloride (Cl-) electrode (green)
m O-rings (on the electrodes)
m Lint-free cloth
m Forceps

Roche Diagnostics
Every 2 months maintenance of the ISE module 863
r To replace ISE electrodes
1
2
2 Disconnect the electrode cords from the electrodes.

A Electrode cord
3
3 To loosen the electrodes from the mounting block, pull
the lever toward the RELEASE position.
I The lever is equipped with a spring. Take care with
your fingers.
A Lever
Roche Diagnostics
4
4 To lock the lever, press the metal clip near the
reference electrode.
A Metal clip
5
5 Remove each of the ISE electrodes.
6 During the electrode removal, use cotton swabs or a

lint-free cloth to wipe up any liquid spilled in the
electrode area or liquid adhering to connecting parts.
• If an O-ring from the electrodes remains inside the
ISE unit, use forceps to remove it.
I Any remaining liquid on ISE electrodes may lower
measurement accuracy.
7
7 Remove the protective caps from both sides of the new
electrodes.
I The connecting part and the new electrodes should
be provided with O-rings.
8 Insert the new electrodes, one after the other, into the
matching color-coded positions of the ISE unit.
A O-ring
Roche Diagnostics
9
9 To fasten the electrodes, pull the lever first to the right
in order to unlock it, and then set it back to LOCK
position.
10 Reconnect the color-coded electrode cords. Verify

that the color of each cord matches the color of the
connected electrode.
A
A Lever
11
r To prime tubings and check

connections
1 Make sure that the top cover is locked, otherwise the

1
interlock function blocks operation.
2
Roche Diagnostics
3
3 Choose the (8) Reagent Prime option.
5
6 6 Choose All in the Prime Item area.

I The prime is complete when the instrument returns
to Standby mode.
9 With the top cover closed, check the connections

inside the ISE units.
I Make sure that no air bubbles enter the system from
the connecting parts and that there is no liquid
leaking inside the ISE units.

11
Roche Diagnostics
r To perform an ISE check and calibrate

the ISE units
1
1 Choose Utility > Maintenance > Check.
2
2 Choose the (2) ISE Check option.

f The measured voltages for ISE Internal Standard
solution are printed 30 times for each electrode.
However, the results at this point can be ignored
because the electrodes are in the process of
conditioning.
6 Wait for 10 minutes and repeat steps 2 to 5.
7 Check the results of the ISE check in the Monitor

window.
8 Make sure that there is no alarm and the difference of

the measured voltages for each of the Na+, K+, Cl-
electrodes stays within the following criteria:

• ± 0.2 mV from cycle to cycle after the first 10 cycles
among 30 cycles.
9 If the difference of the measured voltages is greater

than ± 0.2 mV, perform another ISE check.
11 Calibrate the ISE units before you resume routine

analysis.
u Related topics
• Replacing the Na, K and Cl electrodes of the ISE
module (862)
Roche Diagnostics
868 Quarterly maintenance of the ISE module
Quarterly maintenance of the ISE module

Perform these maintenance actions at least once every
3 months.
In this section
Washing the ISE flow paths (868)
Replacing the pinch valve tubing of the ISE module (871)
Washing the ISE flow paths

To prevent build-up of protein material and bacterial
growth, you must wash the flow paths of the ISE module,
extending from the reagent bottles to the ISE dilution
vessels.

u Moving parts
u Insufficient amount of ECO-D

for ISE calibration
• System time: approximately 12 minutes for (28) ISE
System Wash, approximately 3 minutes for (2) ISE

Check, approximately 8 minutes for ISE calibration
d m 200 mL SysClean solution

(10 mL SysClean diluted 1:20 with deionized water)
m Lint-free cloth
m Deionized water
Roche Diagnostics
Quarterly maintenance of the ISE module 869
r To wash the ISE flow paths
1
2
2 Pull out the reagent aspiration tubing from the ISE
Internal Standard and ISE diluent bottles and insert
them into a bottle filled with the diluted SysClean
solution.
• Be careful not to drip solution from the tubing into
another reagent bottle.
• The reagent aspiration filters must be completely
immersed in the diluted solution.

3
4 4 Choose the (28) ISE System Wash option.
Roche Diagnostics
6 6 Select the ISE module.

I A confirmation window is displayed.
8 Follow the instructions in the confirmation window.

I The Start button is displayed as soon as the
preparation is completed.
9
9 Remove the aspiration tubings from the SysClean
solution.
10 Rinse the reagent aspiration filters with deionized water

and dry them well.
11 Thoroughly remove the wash solution from the tubing

surface using a lint-free cloth moistened with deionized
water.

12 Return the reagent aspiration tubings to their original
reagent bottles.
13 Follow instructions on screen.

f The instrument performs a reagent prime
automatically.
14 Wait until the reagent prime has been completed

before continuing with an ISE check.
r To perform an ISE check
1
2
2 Choose the (2) ISE Check option.

I The electrode voltage is measured 30 times for
each electrode (Na+, K+, Cl- and Ref) and the results
are displayed in the ISE Check report.
Roche Diagnostics
6 Confirm that the measured voltages for ISE Internal

Standard solution are normal and that the difference in
data for the same electrode before and after the check
is stable within the range of 0.2 mV.
8 Calibrate the ISE module before processing routine

samples.
u Related topics
module (862)
Replacing the pinch valve tubing of the ISE module

To prevent inaccuracy of sample aspiration due to the
wearing out of the tubing, you must replace the ISE pinch
valve tubing.

u Moving parts

operation

for ISE calibration
• System time: approximately 2 minutes for (2) ISE Check,
d m Pinch valve tubing

m Forceps

Roche Diagnostics
r To replace the ISE pinch valve tubing
1
2
2 Gently remove both ends of the pinch valve tubing from
the connectors and remove the tubing from the pinch
valve. Discard the old tubing.
A B
A Pinch valve tubing

B Pinch valve
3
3 Insert the new tubing through the pinch valve and
attach both ends of the tubing to the connectors.
Roche Diagnostics
5
6 Perform maintenance action (2) ISE Check (30 cycles).
7 Calibrate the ISE units before you resume routine

analysis.
8 Open the covers of the ISE units and check the

connections.
I Make sure that no air bubbles enter the system from
the connecting parts and there is no liquid leaking
inside the ISE units.
u Related topics
Roche Diagnostics

module
6 months.
In this section
Replacing the reference electrode of the ISE module (874)
Replacing the reference electrode of the ISE module

To ensure the measurement accuracy of the ISE unit, you
must replace the reference electrode.

u Moving parts
operation
Video Replacing the reference electrode


Prime, approximately 2 minutes for (2) ISE Check,
d m Reference electrode
m O-rings (on the electrodes)
m Lint-free cloth
m Forceps
m Cotton swabs

Roche Diagnostics
r To replace the reference electrode
1
2

3
3 Disconnect the electrode cord attached to the
reference electrode.
4
4 Pull the lever towards the RELEASE position and hold it
in this position.
I The lever is equipped with a spring. Take care with
your fingers.
A Lever
Roche Diagnostics
5
5 Press the metal clip near the reference electrode down
and return the lever to the LOCK position.
6 Remove the reference electrode by gently pulling it

back and forth.
7 During the electrode replacement, use cotton swabs or

a lint-free cloth to wipe up any liquid spilled in the
electrode area or liquid adhering to connecting parts.
• If an O-ring from the electrode remains inside the
ISE unit, use forceps to remove it.
I Any remaining liquid on reference electrodes may
lower measurement accuracy.
A
A Metal clip
8
8 Remove the protective caps from both sides of the new
electrode.
9 Verify that the connecting part and the new electrode

are provided with O-rings.
A O-ring
10
10 Insert the new reference electrode in the ISE unit.
Roche Diagnostics
11
11 Pull the lever half-way to the RELEASE position so that
the metal clip can return to its original position.
I The lever will automatically jump back to the LOCK
position.
A
A Lever
12
12 Reconnect the electrode cord to the electrode.
14
15 If the module was masked, unmask it. After installing

the new reference electrode, prime the tubings, check

the connection, perform an ISE check and calibrate the
ISE units.
u Related topics
module (862)
Roche Diagnostics
878 Maintenance as required on the ISE module
Maintenance as required on the ISE module

In this section
Cleaning the dilution vessel of the ISE module (878)
Replacing the sample probe of the ISE module (881)
Eliminating clogging of the sample probe (888)
Cleaning the surface of the ISE module (890)
Draining the degasser water trap of the
Draining the vacuum tank of the ISE support box (893)
Cleaning the dilution vessel of the ISE module

If you observe crystallization and contamination in the ISE
dilution vessel of the ISE module, you must clean it.

u Moving parts
operation
n
• Operator time: approximately 5 minutes

Prime (IS+DIL, 20 cycles)
d m Wash bottle
m Pipette
m Cotton swabs
m Deionized water
m Nozzle receptacle

Roche Diagnostics
Maintenance as required on the ISE module 879
r To clean the ISE dilution vessel
1
2

3
3 Loosen the retaining screws of the vacuum nozzle and
the ISE sipper nozzle.
A B
A Retaining screw of vacuum nozzle

B Retaining screw of ISE sipper nozzle
Roche Diagnostics
4
4 Carefully remove both nozzles and place them into the
nozzle receptacle.
A
A Nozzle receptacle
5
5 To rinse off crystals, inject deionized water into the ISE
dilution vessel and the surrounding area.
A
A Dilution vessel
6
6 Clean the inside of the ISE dilution vessel using cotton
swabs. Avoid bending the small nozzles inside the ISE
dilution vessel. Do not clean the area near the nozzles
with cotton swabs.
• If the nozzles are accidentally bent, contact your
Roche Service representative or technical support.
7 Aspirate the contents of the ISE dilution vessel with a

pipette.
8 Dispose of the contents as liquid waste.
Roche Diagnostics
9
9 Reattach the ISE sipper nozzle and the vacuum nozzle.
A B
A Vacuum nozzle
B ISE sipper nozzle
10
10 Dispose of the nozzle receptacle and insert a new one.
11 Close the ISE unit covers.

A
A Nozzle receptacle
12
13 Perform a reagent prime. Perform an ISE calibration.

I If you continue with the next maintenance action
cleaning the ISE reagent aspiration filters, the
reagent prime can also be performed afterwards.
u Related topics
• Performing a reagent prime on the ISE module (321)
• Cleaning the reagent aspiration filters of the ISE
module (856)
Replacing the sample probe of the ISE module

If the sample probe is bent or otherwise damaged, you
must replace it.
Roche Diagnostics
Detaching the sample probe of the ISE module

To replace the sample probe or to eliminate clogging, you
must remove the probe first.

u Moving parts
n • Approximately 5 minutes

r To detach the sample probe
1
2
2 Remove the pipetter arm cover by pressing the pipetter
arm cover releases on either side and gently lift the
cover.
I When detaching the tubing, water is flowing out of
the tip of the sample probe. Be sure to work above
the rinse station.
Roche Diagnostics
3
3 Unscrew the tubing from the sample probe.
A Tubing
4
4 Locate the probe seal either on the end of the tubing or
in the retaining nut.

A
A Probe seal
5
5 Disconnect the connector of the liquid level sensor.
A Connector of the liquid level sensor
Roche Diagnostics
6
6 Lift the sample probe from the pipetter arm.
Reattaching the sample probe of the ISE module

After having removed the sample probe to replace or
eliminate clogging, you must then reattach the probe.

u Moving parts
n • Approximately 5 minutes

r To reattach the sample probe
1
1 Insert the sample probe into the pipetter arm.
I To ensure proper alignment, the tab on the probe
must slide into the holding slot of the pipetter arm.
Roche Diagnostics
2
2 Reconnect the connector of the liquid level sensor.
3
3 When reconnecting the tubing, make sure a new probe
seal is in place.
I A probe seal, once pulled off, should not be reused
since the edge is deformed. A new probe always
comes with a new seal.
A Probe seal

4
4 Reattach the pipetter arm cover; the rear section first
and then the front section.
A Pipetter arm cover
Roche Diagnostics
5
6 Power on the instrument or the module.
7 Before you resume routine operation, carry out the

3 next procedures:
To check the horizontal alignment of a probe, To
perform an air purge and check the operation of the
probe, and To perform a mechanism check.
u Related topics
Checking the sample probe of the ISE module

To ensure proper operation of the sample probe, you must
check the probe after installation.

u Moving parts

r To check the horizontal alignment of

the ISE sample probe
1
2
2 Choose the (5) ISE Probe Check option.

f The sample probe moves to its first stop position
(e.g., the rinse station).
5 Choose the Next button.
6 Visually check the alignment of the sample probe

through the top cover of the module. The probe tip
must be centered above the ISE dilution vessel.
Roche Diagnostics
7 To manually adjust the position, firmly hold the pipetter

arm and gently bend the sample probe over its entire
length in an arc.
8 Choose the Next button.
9 To terminate the ISE probe check mode, choose the

Stop button in the Confirmation window.
r To perform an air purge and check the

operation of the ISE sample probe
1
2
2 Choose the (6) Air Purge option.
4
I To select only particular modules, clear the SU
check box.

5
5 Choose the syringe (or all syringes) to be purged of air.

f The maintenance action is finished when the
instrument returns to Standby mode.
r To perform a mechanism check
1
Roche Diagnostics
2
2 Choose the (3) Mechanism Check option.
4
5
5 Choose the Limit Cycles option and enter “10” cycles.
7 Visually check through the closed top cover that the

following conditions are maintained:
• The sample probe descends into the center of the
ISE dilution vessels.
• The sample probe does not touch any other parts.
• At the rinse stations, the outside of the sample
probe is rinsed with water.
I After the mechanism check, the instrument returns
to Standby mode. If an error is detected, an
Eliminating clogging of the sample probe

If you detect inaccurate pipetting, you must eliminate
clogging inside the sample probe.
If a sample aspiration error occurs, perform a sample

probe wash. If clogging cannot be eliminated by this
maintenance action, the sample probe must be detached
and cleaned manually. A sample probe must be replaced if
it is bent or damaged. Positional adjustment is required
afterwards.

u Moving parts

• System time: approximately 18 minutes (6 minutes for
(18) Sample Probe Wash, 2 minutes for (6) Air Purge,
10 minutes for (3) Mechanism Check)
Roche Diagnostics
d m Cleaning wire (stainless steel) 0.2 mm diameter

m Lint-free cloth
m Deionized water

r To perform a sample probe wash
1
2
2 Choose the (18) Sample Probe Wash option.

• If the sample probe is still clogged, continue with
the next procedures.
• If sample aspiration errors occur frequently or if an
alarm for clogging of the sample probe occurs and
is not reset after cleaning (maintenance action

(18) Sample Probe Wash), the sample probe must
be detached and clogging must be eliminated.
I The inside of the sample probe is washed with
SmpCln1 (basic wash).
Roche Diagnostics
r To eliminate clogging
1
1 To eliminate clogging, use cleaning wire (stainless
steel) with 0.2 mm diameter.
2 Insert the cleaning wire into the probe tip and run it
through the probe.
3 Rinse the inside of the probe thoroughly with deionized

water, then wipe the probe with lint-free cloth.
u Related topics
• Detaching the sample probe of the ISE module (882)
• Reattaching the sample probe of the ISE module (884)
A Cleaning wire
Cleaning the surface of the ISE module



cleaning.


u Moving parts
operation
Roche Diagnostics

m Deionized water

r To clean module surface

I If necessary, move the pipetters and other movable
parts manually to clean the surface.

u Related topics
Draining the degasser water trap of the ISE support box

An alarm is issued (“Full Degasser Trap Tank”) when there is
water or liquid waste in the degasser water trap. If this
alarm appears, you must drain the degasser water trap.
If an alarm is issued frequently, contact your Roche Service

representative.

u Infectious waste
d m Beaker
Roche Diagnostics

r To drain the degasser water trap of

the ISE support box
1
1 Locate the drain tubing of the degasser water trap on
the rear side of the ISE support box.
2 Detach the drain tubing of the ISE support box.
A Drain tubing of the degasser water trap
3
3 Drain the liquid waste into a beaker.
4 Reattach the drain tubing of the ISE support box.
5 Dispose of the contents of the beaker according to

your laboratory’s biohazardous waste disposal
regulations.
u Related topics
Roche Diagnostics
Draining the vacuum tank of the ISE support box

An alarm is issued (“liquid in vacuum tank”) when there is
water or liquid waste in the vacuum tank. If this alarm
appears, you must drain the vacuum tank.

representative.

u Infectious waste
d m Beaker

r To drain the vacuum tank of the

ISE support box
1
1 Locate the drain tubing of the vacuum tank on the rear
side of the ISE support box.
2 Detach the drain tubing of the ISE support box.
A Drain tubing of the vacuum tank
Roche Diagnostics
3
4 Reattach the drain tubing of the ISE support box.

regulations.
u Related topics
Roche Diagnostics
895
Table of contents
Maintenance of the c 701 and c 702

modules 15
In this chapter 15
List of maintenance actions on the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 897
Daily maintenance of the c 701 and c 702 modules . 899
operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 899
Cleaning the pipetter probes of the c 701 and
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 902
15 Maintenance of the c 701 and c 702 modules

Cleaning the reaction cell rinse nozzles of the
c 701 and c 702 module. . . . . . . . . . . . . . . . . . . . . . 905
Weekly maintenance of the c 701 and c 702 modules 907
Washing the reaction parts of the c 701 and
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 907
Cleaning the reaction cell covers of the c 701 and
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 909
Cleaning the rinse stations of the c 701 and c 702
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 912
Cleaning the discharge chute for reagent caps on
the c 702 module. . . . . . . . . . . . . . . . . . . . . . . . . . . . 914
Checking the reagent cassette gripper on the
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 917
Monthly maintenance of the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 919
Replacing reaction cells and cleaning the
incubation bath of the c 701 and c 702 modules . 919
Preparing the incubator bath cleaning of the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . 920
Removing the reaction cells of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . 921
Cleaning the incubation bath of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . 923
Reinstalling the reaction cells of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . 925
Completing the incubator bath cleaning of the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . 927
incubation bath of the c 701 and c 702 modules
with the instrument powered off . . . . . . . . . . . . . . . 929
Roche Diagnostics
896
Table of contents
Cleaning the aspiration filters of the c 701 and

c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 932
Cleaning the filters behind the front doors of the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . . . . 934
Quarterly maintenance of the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 936
Cleaning the ultrasonic mixers of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 936
Cleaning the solenoid valve filter of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 940
Every 6 months maintenance of the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 941
Replacing the photometer lamp of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 941
Maintenance as required on the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 947
Eliminating clogging of the reaction cell rinse
nozzles of the c 701 and c 702 modules . . . . . . . . 947
Replacing nozzle tips on reaction cell rinse
nozzles of the c 701 and c 702 modules . . . . . . . . 949
Draining the vacuum tank of the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 953
Replacing the pipetter probes of the c 701 and
c 702 modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 955
Detaching a sample or reagent probe of the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . 955
Reattaching a sample or reagent probe of the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . 958
Checking the sample and reagent probes of
the c 701 and c 702 modules . . . . . . . . . . . . . . 960
Eliminating clogging of pipetter probes of the
c 701 and c 702 modules. . . . . . . . . . . . . . . . . . . . . 965
Cleaning the surface of the c 701 and c 702
modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 967
Cleaning the cap waste box on the c 702 module 968
Cleaning the reagent cassette gripper on the
c 702 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 970
Roche Diagnostics
List of maintenance actions on the c 701 and c 702 modules 897
List of maintenance actions on the c 701

and c 702 modules
table.


PO Powered off
SB Standby mode

Interval Maintenance actions c 701 c 702 Instrument mode

Daily Washing with the wash rack during continuous l l -(1)
operation (899)
Cleaning the pipetter probes of the c 701 and c 702 l l MC/PO
module (902)
Cleaning the reaction cell rinse nozzles of the c 701 and l l SB/MM/PO
c 702 module (905)
Weekly Washing the reaction parts of the c 701 and c 702 l l SB/MM
module (907)
Cleaning the reaction cell covers of the c 701 and l l SB/MM/PO
c 702 module (909)
Cleaning the rinse stations of the c 701 and c 702 l l MC/PO
module (912)
Cleaning the discharge chute for reagent caps on the - l SB/MM/PO
c 702 module (914)
Checking the reagent cassette gripper on the c 702 - l MC/PO
module (917)
Monthly Replacing reaction cells and cleaning the incubation l l SB
bath of the c 701 and c 702 modules (919) or
Replacing reaction cells and cleaning the incubation l l PO
bath of the c 701 and c 702 modules with the
instrument powered off (929)
Cleaning the aspiration filters of the c 701 and c 702 l l SB/MM/PO
modules (932)
Cleaning the filters behind the front doors of the c 701 l l SB/MM/PO
y Overview of maintenance actions
Roche Diagnostics
898 List of maintenance actions on the c 701 and c 702 modules
Interval Maintenance actions c 701 c 702 Instrument mode

Quarterly Cleaning the ultrasonic mixers of the c 701 and c 702 l l PO/SB/MM
modules (936)
Cleaning the solenoid valve filter of the c 701 and c 702 l l PO
modules (940)
Every 6 months Replacing the photometer lamp of the c 701 and c 702 l l PO
modules (941)(2)
As required Eliminating clogging of the reaction cell rinse nozzles of l l SB/MM/PO
Replacing nozzle tips on reaction cell rinse nozzles of l l SB/MM/PO
Draining the vacuum tank of the c 701 and c 702 l l SB/MM/PO
modules (953)
Replacing the pipetter probes of the c 701 and c 702 l l PO
modules (955)
Eliminating clogging of pipetter probes of the c 701 and l l PO
c 702 modules (965)
Cleaning the surface of the c 701 and c 702 l l SB/MM/PO
modules (967)
Cleaning the cap waste box on the c 702 module (968) - l SB/MM/PO
Cleaning the reagent cassette gripper on the c 702 - l MC/PO
module (970)
(1) From any operating mode such as Standby or Rack Reception mode, or within a maintenance pipe.
(2) Or if the photometer check value exceeds 14 000 or when used for more than 750 hours of power-on time.
u Related topics
Roche Diagnostics
Daily maintenance of the c 701 and c 702 modules 899
Daily maintenance of the c 701 and c 702

modules
You must perform these maintenance actions every day.
Contamination of flow paths or probes may cause

incorrect test results or clogging. Therefore, regularly
perform the stated maintenance actions.
In this section
operation (899)
Cleaning the pipetter probes of the c 701 and c 702
module (902)
Cleaning the reaction cell rinse nozzles of the c 701 and
c 702 module (905)


pipe.

You can also process the wash rack prior to regular daily
calibration. A full calibration of the ISE tests is required
after the washing.
Roche Diagnostics
900 Daily maintenance of the c 701 and c 702 modules

wash rack.
• During the washing, ISE tests must be masked (P.Mask).
Only photometric and immunology tests can be
processed. Do not load any samples with ISE requests.
If you load samples with ISE requests, the ISE requests
cannot be processed until ISE tests are unmasked
again.
operation (899)
Only 300 µL are required for an ISE module with one

detection unit.
containers.
volume of standard cup).
Roche Diagnostics

modules)
m SysClean
m Activator

1
1 Place sample tubes or cups into rack positions 1 to 3 on
a wash rack.

A 2 Pipette suitable amounts of the system reagents into
B the sample tubes.
C
containers.

as instructed.

r To wash with wash rack during

operation
Roche Diagnostics
2

displayed.

results for ISE.

buffer on the same magazine: Wash rack, calibrator
rack containing the ISE calibrators, QC rack containing
the QC materials for ISE tests. To start the washing,
choose Start > Start.


u Related topics
operation (899)
Cleaning the pipetter probes of the c 701 and c 702

module
To ensure optimal condition of all probes and
measurement accuracy of the module, you must clean the
outside of the reagent probe and sample probe.
q Do not bend or damage the lower end of the probes

during cleaning. Move the pipetter arm gently. Do not move
it up or down.

u Moving parts
u Fire and burns
operation
Roche Diagnostics
c At the end of analysis each day
n • Operator time: approximately 3 minutes per module

• System time: approximately 1 minute for (1) Reset
d m Alcohol
m Lint-free cloth
m Paper towels

mode) (783)
r To clean the outside of the sample

probes
1
A Rear cover
Roche Diagnostics
2
2 Remove the plexiglass cover.
3 Move the sample probes to an accessible position.
A Plexiglass cover
4
4 Wipe the outside of each sample probe with a lint-free
cloth moistened with alcohol:
• Hold the pipetter arm with one hand and wipe with
the other.
on the instrument surface as the finish may be

damaged.
5 Reattach and close all covers.
r To clean the outside of the reagent

probes
1
1 Move the reagent probes by hand to an accessible
position.
2 Wipe the outside of the reagent probe with a lint-free

cloth moistened with alcohol:
• Always wipe from top to bottom
the other.
• To prevent carryover, use a new lint-free cloth for
each probe.
damaged.
3 Reattach and close all covers.
4 Terminate manual cleaning (Maintenance mode).
5 Perform a reagent registration via Reagent > Setting

> Reagent Registration.
Roche Diagnostics
u Related topics
• Detaching a sample or reagent probe of the c 701 and
c 702 modules (955)
• Reattaching a sample or reagent probe of the c 701
Cleaning the reaction cell rinse nozzles of the c 701 and

c 702 module
To ensure accurate results and no water overflow from
reaction cells, you must clean the reaction cell rinse
nozzles. Regular cleaning prevents contamination, crystal

formation, and clogging.
Replace a nozzle tip if its corner or bottom is worn.

u Replacing nozzle tips on reaction cell rinse nozzles of

u Infectious waste
u Moving parts
operation
n • Approximately 5 minutes per module

• Approximately 1 minute for (1) Reset
d m Deionized water
m Lint-free cloth

Roche Diagnostics
r To clean the reaction cell rinse

nozzles
1
1 Lift off the entire unit by loosening the retaining screw
of the reaction cell rinse unit.
I There are 3 reaction cell rinse units.
A B C
A Reaction cell rinse unit 3

B Reaction cell rinse unit 2
C Reaction cell rinse unit 1
2
2 Wipe the nozzles in a downward motion with a lint-free
cloth moistened with deionized water.
3 Put the reaction cell rinse units back in place and fasten
the retaining screws.
u Related topics
Roche Diagnostics
Weekly maintenance of the c 701 and c 702

modules
In this section
Washing the reaction parts of the c 701 and c 702
module (907)
Cleaning the reaction cell covers of the c 701 and c 702
module (909)
Cleaning the rinse stations of the c 701 and c 702
module (912)
Cleaning the discharge chute for reagent caps on the
c 702 module (914)
Checking the reagent cassette gripper on the c 702
module (917)

Washing the reaction parts of the c 701 and c 702 module
To prevent contamination of the reaction cells or the liquid
waste flow path, you must wash the reagent probes and
reaction cells.

u Infectious waste
u Moving parts

• System time: approximately 27 minutes for (7) Wash
Reaction Parts plus 15 minutes for (4) Cell Blank
Measurement
d • NaOHD reagent cassettes (70 mL minimum volume on

each reagent disk; consumption 63 mL)
m SmpCln1 (approx. 1 mL)

Roche Diagnostics
908 Weekly maintenance of the c 701 and c 702 modules
r To wash the reaction parts
1
1 Make sure that the NaOHD volume is sufficient:
• Select the corresponding module.
• Check the total remaining volume of all NaOHD
reagent cassettes per reagent disk.
• If the remaining volume is below 70 mL on a reagent
disk, load another NaOHD reagent cassette.
2
3
3 Choose the (7) Wash Reaction Parts option.

5

f The maintenance action is finished when the module
returns to Standby mode.
r To perform a cell blank measurement
1
2
2 Choose the (4) Cell Blank Measurement option.
Roche Diagnostics
4
r To view the cell blank test results
1 To view the recent cell blank measurement report,

choose Print > History.
2
2 Check if any reaction cells are listed in the Abnormal
Cell List report:
• If no reaction cells are listed in the abnormal cell
list, you can continue without any further action.
• If reaction cells are listed in the abnormal cell list,
replace all listed reaction cells by new ones.

u Related topics
• Changing reagent cassettes on the c 701 module (330)
• Preparing the incubator bath cleaning of the c 701 and
c 702 modules (920)
bath of the c 701 and c 702 modules with the
A
instrument powered off (929)
A Reaction cells
Cleaning the reaction cell covers of the c 701 and c 702

module
To ensure that the reaction cell covers remain free of
reagent and reaction mixture, you must clean them as well
as the ultrasonic mixer covers.

u Infectious waste
u Moving parts
u Fire and burns
Roche Diagnostics
Video Cleaning the reaction cell covers
d m Cotton swabs
m Lint-free cloth
m Alcohol
m Deionized water

r To clean the reaction cell covers

1 1 Remove the reaction cell covers above the ultrasonic

mixers by unscrewing the 4 highlighted screws.
A Reaction cell covers
2
2 Remove all remaining reaction cell covers.
I To lock or unlock the bayonet cap, you must push
down and rotate the caps.
A B
A Reaction cell cover

B Bayonet caps (only on the leftmost reaction cell
cover)
Roche Diagnostics
3
3 Wipe the front and rear of all reaction cell covers using
a lint-free cloth moistened with alcohol.
I Take care not to splash alcohol into the reaction
cells.
Do not place a lint-free cloth moistened with alcohol
damaged.
4
4 Pinch the sides of the ultrasonic mixer covers and pull
them off the reaction cell covers.
5 Wash the ultrasonic mixer covers with deionized water.
6 If dust and dirt remain, wipe the ultrasonic mixer covers

using a cotton swab moistened with alcohol.

7 Reattach the dried ultrasonic mixer covers.
I If you are also performing monthly maintenance, we
recommend that you replace reaction cells and
clean incubation bath.
8 Put the reaction cell covers back in place.
u Related topics
• Preparing the incubator bath cleaning of the c 701 and
c 702 modules (920)
Roche Diagnostics
Cleaning the rinse stations of the c 701 and c 702 module

the rinse station, you must clean the rinse stations of the
sample and reagent probes.

u Infectious waste
u Moving parts
u Fire and burns

d
m Wash bottle
m Cotton swabs
m Alcohol
m 2% ECO-D solution
m Deionized water

mode) (783)
r To clean the rinse stations
1
1 Open the top cover, rear cover, and the plexiglass
cover of the module.
Roche Diagnostics
2
2 Move the pipetter probes to positions that leave the
rinse stations easily accessible.
A 4 rinse stations for reagent probes
3
3 Dilute the 100% ECO-D solution to a 2% solution.
surface.

4
4 Clean the inside of the rinse stations using cotton
swabs moistened with 2% ECO-D solution.
Roche Diagnostics
5
5 Inject about 10 mL of 2% ECO-D solution into each
rinse station.

station.
7 Return the sample and reagent probes to their original

positions.
8 Close all covers of the module.
9 If instrument was in manual cleaning (Maintenance

mode), terminate manual cleaning (Maintenance mode).
u Related topics
Cleaning the discharge chute for reagent caps on the

c 702 module
To prevent spills from reagent caps, you must clean the

inner surfaces and the base plate of the discharge chute.

u Moving parts
n Approximately 3 minutes per c 702 module
d m Cotton swabs
m Lint-free cloth
m Deionized water

r To clean the discharge chute for

reagent caps
1
1 Choose Overview.
Roche Diagnostics
2
2 Choose the Reagent Manager Overview button .
3
3 Make sure that there are no reagent cassettes in the
buffer rotor.
4 If the buffer rotor is not empty, do one of the following:

• Manually control reagent cassettes on the buffer
rotor.
• Unload reagent cassettes from the buffer rotor.

5
5 Take out the cap waste box and dispose of the reagent
caps.
A
A Cap waste box
Roche Diagnostics
6
6 Remove the cover by loosening the retaining screw at
the discharge chute.
I Do not insert your hands or fingers deeply into the
opening. Use a long cotton swab.
A B
A Retaining screw B Cover
7
7 Clean the inner surfaces of the discharge chute with
lint-free cloths and cotton swabs moistened with
deionized water.
8 Return the cover and fasten the retaining screw at the

discharge chute.
9 Return the cap waste box back in place.
A Inner surfaces of discharge chute
10
10 If you have emptied the cap waste box, to reset the cap
counter to 0 choose the Waste Box Reset button.
11 Unmask the module if it was masked.
u Related topics
Roche Diagnostics
Checking the reagent cassette gripper on the c 702

module
To ensure that the bottom side of the reagent cassette
gripper is free of reagent splashes, you must clean the
bottom side of the reagent cassette gripper.

u Moving parts
d m Cotton swabs
m Deionized water

m Instrument is in manual cleaning (Maintenance mode).
mode) (783)
r To check the bottom side of the

reagent cassette gripper on the c 702
module for reagent splashes
1
1 Move the reagent cassette gripper with your hand to an
accessible position.
Roche Diagnostics
2
2 Check the bottom side of the reagent cassette gripper
for reagent splashes.
3 If there are any splashes on the surface, clean the

surface with cotton swabs moistened with deionized
water.
4 Manually move the reagent cassette gripper either to

the leftmost or the rightmost position of the module.
I If the reagent cassette gripper is not moved to the
leftmost or rightmost position, the module will not
A resume operation and an alarm will be issued.
A Bottom side of reagent cassette gripper 5 Close the top cover.
u Related topics
• Cleaning the reagent cassette gripper on the c 702
module (970)
Roche Diagnostics
Monthly maintenance of the c 701 and c 702 modules 919
Monthly maintenance of the c 701 and c 702

modules
In this section
Replacing reaction cells and cleaning the incubation bath
of the c 701 and c 702 modules (919)
of the c 701 and c 702 modules with the instrument
powered off (929)
Cleaning the aspiration filters of the c 701 and c 702
modules (932)
Cleaning the filters behind the front doors of the c 701 and
c 702 modules (934)

of the c 701 and c 702 modules
The reaction cells gradually deteriorate with use.
Contamination inside the incubation bath or on the
photometer window will reduce the reproducibility of
measurement results.
To ensure the reproducibility of test results, you must

replace the reaction cells and clean the incubation bath at
least once a month.
Roche Diagnostics
920 Monthly maintenance of the c 701 and c 702 modules
Preparing the incubator bath cleaning of the c 701 and c 702 modules
To replace the reaction cells and clean the incubation
bath, you must first perform the maintenance action
(10) Incubator Bath Cleaning.
The incubation bath can only be cleaned on one module

type at a time. Therefore select either c 701/c 702
modules or c 502 modules.
! WARNING
Incorrect results due to shortage of ECO-D
A reduced concentration of ECO-D may cause bacterial
growth in the incubation bath and may thus lead to
decreased measurement accuracy.
r Do not mix ECO-D with other solutions.

r To perform incubator bath cleaning
1
1 In Reagent > Status check the remaining volume of
ECO-D.
2
Roche Diagnostics
3
3 Choose the (10) Incubator Bath Cleaning option.
5

f The water is drained from the incubation bath.
7

8
8 Wait until Incubator Bath Cleaning (Wait) is displayed
before starting with the next maintenance action.
Removing the reaction cells of the c 701 and c 702 modules

To clean the incubation bath, you must first remove the
reaction cells.

u Infectious waste
u Moving parts
u Spilled sample
Video Removing the reaction cells
j m The instrument or module is in Maintenance mode.

Roche Diagnostics
r To remove the reaction cells
1
1 Remove all reaction cell covers.
I To lock or unlock the bayonet caps, you must push
down and rotate the caps.
A B
A Reaction cell cover

B Bayonet caps (only on the leftmost reaction cell
cover)
2
2 Remove all reaction cell rinse units.
A B C D

D Retaining screw
Roche Diagnostics
3
3 Remove the reaction cells from the reaction disk.
I Do not touch the surfaces of reaction cells that will
be used again.
4 Discard the used reaction cells.
A Reaction cells

Cleaning the incubation bath of the c 701 and c 702 modules
Before inserting the new reaction cells, you must clean the
incubation bath.

u Infectious waste
u Moving parts
u Spilled sample
Video Cleaning the incubation bath
d m Deionized water
m 2% ECO-D
m Cotton swabs
m Lint-free cloth

Roche Diagnostics
r To clean the incubation bath
1
1 Wipe the inner surfaces of the incubation bath with a
clean lint-free cloth.
2
2 Wipe the indented parts near the ultrasonic mixers with
a cotton swab.
A Indented parts near ultrasonic mixers
3
3 Carefully wipe the photometer windows with a clean
lint-free cloth (or a cotton swab) moistened with
deionized water.
I Do not scratch the photometer windows when
cleaning. Use only lint-free cloth immersed in
deionized water.
Roche Diagnostics
4
4 Remove the incubation bath drain filters by grasping
them by their handle with the filter removal tool.
I The modules are equipped with 2 drain filters.
5 Clean and rinse the filters with deionized water and

return them to their place.
A B
A Filter removal tool

B Drain filter
Reinstalling the reaction cells of the c 701 and c 702 modules

After having cleaned the incubation bath, you must
reinstall the reaction cells.

u Infectious waste
u Moving parts
u Spilled sample
Video Reinstalling the reaction cells
n Approximately 10-15 minutes
d m Reaction cells

Roche Diagnostics
r To reinstall the reaction cells
1
1 Insert all reaction cells segments.
A Reaction cells
2
2 Rotate the reaction disk by hand.
I Make sure that the bottoms of the reaction cells do
not touch the incubation bath drain filters.
3 Return the reaction cell covers.
4 Return the reaction cell rinse units ensuring that the

reaction cell rinse units are correctly aligned.
5 Close the top cover of the module.
A Reaction disk
Roche Diagnostics
Completing the incubator bath cleaning of the c 701 and c 702 modules
After having reinstalled the reaction cells, you must
complete incubator bath cleaning.
Consumption of ECO-D The following table shows the consumption of ECO-D and
the time required for exchanging the incubation water
depending upon the setting of the exchange rate.
You can select the water exchange rate on Utility > System
> Analyzer Settings. To select the low water exchange rate,
you must clear the Incubation Water Exchange check box.
Only if the water quality is good use low water exchange
rate.
High exchange rate (long mode) Low exchange rate (short mode)
Consumption of ECO-D (approx.) 15 mL 12 mL
Runtime (approx.) 17 min 9 min
y High exchange rate vs. low exchange rate
! WARNING

n Approximately 5-20 minutes for refilling the incubation

bath (depending on module and water exchange rate),
27 minutes for (7) Wash Reaction Parts, 15 minutes for
d m ECO-D (see table above for consumption)

• NaOHD reagent cassettes (70 mL minimum volume on
m Deionized water
Roche Diagnostics
r To complete incubator bath cleaning
1
1 Press the F1 button behind the front doors.
f The incubation bath is filled with water again and
ECO-D is added. The instrument then returns to
Standby mode.
2
3
5
7


Cell List report:
Roche Diagnostics
u Related topics
• Washing the reaction parts of the c 701 and c 702
module (907)
• Cleaning the incubation bath of the c 701 and c 702
modules (923)

of the c 701 and c 702 modules with the instrument
powered off
As an alternative to cleaning the incubation bath in
Standby mode, you can also clean the incubation bath
while the instrument is powered off.

u Sharp objects
u Infectious waste
u Moving parts
u Spilled sample
! WARNING
n • Operator time: approximately 16 minutes per c 701,

20 minutes per c 702 module
• System time: approximately 2 minutes for draining the
incubation bath, 6 minutes for (5) Incubation Water
Exchange, 27 minutes for (7) Wash Reaction Parts, and
15 minutes for (4) Cell Blank Measurement
Roche Diagnostics
d m ECO-D
• NaOHD reagent cassettes (70 mL minimum volume on
m Cotton swabs
m Lint-free cloth
m Deionized water or 2% ECO-D solution

r To drain the incubation bath
1
1 Turn the incubation bath drain tap, located behind the
front door, to the DRAIN position and drain the
incubation bath.
• Do not let all the water drain.
• Leave a small amount of water to just cover the
bottom of the incubation bath.
2 To stop draining, turn the incubation bath drain tap

back to its OPERATION position.
A Incubation bath drain tap
1 Remove all the reaction cells.
2 Clean the incubation bath.
3 Reinstall the reaction cells.
1 Gradually pour about 500 mL of deionized water into

2
Roche Diagnostics
3 3 Choose the (5) Incubation Water Exchange option.
4 Choose the Select option.
5
7

8
9
11
13

Roche Diagnostics

Cell List report:
u Related topics
• Removing the reaction cells of the c 701 and c 702
modules (921)
• Cleaning the incubation bath of the c 701 and c 702
modules (923)
• Reinstalling the reaction cells of the c 701 and c 702
modules (925)
Cleaning the aspiration filters of the c 701 and c 702

modules
To prevent clogging of the aspiration filters which may lead
to insufficient reaction cell cleaning, you must clean the
aspiration filters of the CellCln1 and CellCln2 bottles.

u Infectious waste

• System time: approximately 6 minutes for (9) Cell
Detergent Prime
d m Deionized water
m Paper towels

Roche Diagnostics
r To clean the aspiration filters
1
2
2 Take out the wash solution bottles.
3 Remove the tubing from the wash solution bottles and

unscrew the aspiration filter from the tubing end.
4 Clean and rinse the aspiration filter with deionized

water.
A B
A Aspiration filter B Wash solution bottle
5
5 Screw the aspiration filter onto the tubing end and
place it back into the bottle.
6 Return the bottle.
Roche Diagnostics
9
9 If you have replaced a wash solution bottle, do the
following:
• Choose Reagent > Status.
• Choose the Reagent Volume Reset button.
r To perform a cell detergent prime
1
2 2 Choose the (9) Cell Detergent Prime option.
4

I The maintenance action is finished when the module
Cleaning the filters behind the front doors of the c 701

and c 702 modules
To prevent dust or dirt accumulating in the filters leading
to faulty temperature control of the instrument, you must
clean the filters.
Roche Diagnostics
d m Paper towels
m Water for rinsing
m Vacuum cleaner

r To clean the cooling unit filters

behind the front doors
1

2
2 CAUTION! Burns due to contact with the radiator
behind the filter.
Avoid touching the radiator when removing the filter.
2 Remove the cooling unit filters by pulling them forward
from the filter retaining brackets.
3 Vacuum the cooling unit filters.
4 If the cooling unit filters are visibly contaminated, rinse

them with water and blot dry with paper towels.
5 Reinstall the cooling unit filters.
6 Close the front doors of the module.
u Related topics
Roche Diagnostics
936 Quarterly maintenance of the c 701 and c 702 modules
Quarterly maintenance of the c 701 and

c 702 modules
3 months.
In this section
Cleaning the ultrasonic mixers of the c 701 and c 702
modules (936)
Cleaning the solenoid valve filter of the c 701 and c 702
modules (940)
Cleaning the ultrasonic mixers of the c 701 and c 702

modules
To prevent contamination and precipitation on the surface
of the ultrasonic mixers leading to inaccurate results, you

must clean the ultrasonic mixers.

u Electric shock
u Infectious waste
u Moving parts

incubation bath; 18 minutes for refilling the incubation
bath; 3 minutes for (9) Cuvette Mixing check
d m 2% ECO-D solution
m Deionized water
m Cotton swabs

Roche Diagnostics
Quarterly maintenance of the c 701 and c 702 modules 937
r To clean the surface of the ultrasonic

mixer
1
2
4

f The water drains from the incubation bath.

6
7
7 Wait until Incubator Bath Cleaning (Wait) is displayed.
8
8 Remove the reaction cell covers above the ultrasonic
mixers by unscrewing the 4 highlighted screws.
A Reaction cell covers
Roche Diagnostics
9
9 Remove the reaction cells near the ultrasonic mixers (at
least 3 reaction cell segments).
I Do not to touch the surfaces of reaction cells.
A Ultrasonic mixer
10
11
11 Gently wipe the surface of the ultrasonic mixers with
cotton swabs moistened with 2% ECO-D solution.
12 Wipe off the wash solution with cotton swabs

13 Return the removed sections of reaction cells.
Roche Diagnostics
Quarterly maintenance of the c 701 and c 702 modules 939
16
16 To terminate incubator bath cleaning, press the F1
button behind the front doors.
f The incubation bath fills with water and ECO-D is
added to the water. The instrument returns to
Standby mode.
r To check the intensity of the

ultrasonic output
1

2
2 Choose the (9) Cuvette Mixing option.
4
5
5 Clear the With Cell Wash check box.
I If selected, it would rinse all reaction cells prior to
the check.
Roche Diagnostics
Cleaning the solenoid valve filter of the c 701 and c 702

modules
To prevent contaminants entering the solenoid valve unit
when the valve opens for air, you must clean the filter of
the solenoid valve unit and the inner walls.

u Moving parts

r To clean the solenoid valve filter

1
2
2 Turn the filter cover to remove it and pull out the
sponge.
3 If the sponge is dirty, wash it with tap water.
4 Dry the sponge well and reinstall it.
6 Start up the instrument again.
u Related topics
Roche Diagnostics
Every 6 months maintenance of the c 701 and c 702 modules 941
Every 6 months maintenance of the c 701

and c 702 modules
6 months.
In this section
Replacing the photometer lamp of the c 701 and c 702
modules (941)
Replacing the photometer lamp of the c 701 and c 702

modules
To ensure reproducibility of measurement, you must
replace the photometer lamp.

The total power-on time is displayed on the cumulative
operation list. You can view this list via Print > Utility
> Cumulative Operation List.

u Infectious waste
u Moving parts
u Fire and burns
Videos • Removing the photometer lamp

• Installing a new photometer lamp
c • If the photometer lamp has been used for more than

6 months (or 750 hours of power-on time) or if the
photometer check value exceeds 14 000 absorbance
units.

• System time: approximately 3 minutes for
(3) Photometer Check; 30 minutes waiting for lamp to
cool down; 30 minutes waiting for lamp stabilization;
d m Alcohol
m Lint-free cloth
m Photometer lamp
Roche Diagnostics
942 Every 6 months maintenance of the c 701 and c 702 modules
j m For checking the light intensity: The instrument or

module is in Standby mode.
m The instrument is powered off.
r To check the light intensity
1 Make sure that the instrument or module is in Standby

mode.
2
3
3 Choose the (3) Photometer Check option.
5

f Water is injected from the rinsing mechanism into
reaction cell no. 1 and the absorbance of the water
is measured for each available wavelength.
7 Choose Print > History.
8 Choose the Photometer Check report.
9 Check the absorbance values in the photometer check

report.
If the readings exceed 14 000 absorbance units at
340 nm, or if the readings are different from the
previous one, do the following:
• Verify that the reaction cells, the incubation bath,
and the photometer windows are free of
• Verify that the reaction cells are not scratched or
cracked. Verify that the reaction cells are at least
half filled with water.
• If the results do not improve, replace the
photometer lamp.
Roche Diagnostics
r To remove the photometer lamp
1 Make sure that the instrument or module is powered

off.
2
3 3 Choose the (13) Change Photometer Lamp option.
5

f The power supply to the photometer lamp is

switched off during the execution of the
maintenance action (13) Change Photometer Lamp.
7 CAUTION! Burns due to hot surface of the photometer

lamp unit.
Check that the photometer lamp unit has cooled down
before replacing the lamp.
7 Wait about 30 minutes for the photometer lamp and
lamp housing to cool down.
8
9 Open the right front door.
A B
A Top cover
B Right front door
Roche Diagnostics
10
10 Open the photometer lamp cover.
11 Disconnect the connector of the photometer lamp

cables.
12 Loosen the cables from the cable clip.
13 Take out the photometer lamp by loosening both

retaining screws.
14 Remove the retaining screws from the photometer

lamp.
A B C D
I The retaining screws are used to install a new
A Retaining screws C Connector photometer lamp.
B Cable clip D Photometer lamp
cover
r To install a new photometer lamp
1 Make sure that the instrument or module is powered

off.
2
2 Insert the retaining screws from the old photometer
lamp into the new photometer lamp.
3 Insert the new photometer lamp:

A • Align the pin hole in the photometer lamp base with
B the guide pin of the photometer lamp housing.
• Tighten the 2 photometer lamp retaining screws.
C
I Be careful not to touch the glass part of the new
photometer lamp. If you do touch the glass, wipe it
D
off with a lint-free cloth moistened with alcohol.
A Guide pin C Retaining screws

B Pin hole D Connector
Roche Diagnostics
4
4 Secure the photometer lamp cables with the cable clip.
5 Plug in the connector.
6 Close the cover of the photometer lamp.
7 Close the front door of the module.
8 Close the covers of the module.
10 Wait about 30 minutes for the photometer lamp to

stabilize.
A B
A Photometer lamp B Cable clip

cables
11

12
I A cell blank measurement is necessary to
compensate for a possible change in light intensity.
14

Roche Diagnostics
17
17 Check if any cells are listed in the Abnormal Cell List
report:
u Related topics
module (907)
A Reaction cells
Roche Diagnostics
Maintenance as required on the c 701 and c 702 modules 947
Maintenance as required on the c 701 and

c 702 modules
In this section
Eliminating clogging of the reaction cell rinse nozzles of
Replacing nozzle tips on reaction cell rinse nozzles of the
c 701 and c 702 modules (949)
Draining the vacuum tank of the c 701 and c 702
modules (953)
Replacing the pipetter probes of the c 701 and c 702
modules (955)
Eliminating clogging of pipetter probes of the c 701 and
c 702 modules (965)
Cleaning the surface of the c 701 and c 702 modules (967)
Cleaning the cap waste box on the c 702 module (968)

Cleaning the reagent cassette gripper on the c 702
module (970)

the c 701 and c 702 modules
If reaction mixture remains in the reaction cells or water
overflows from reaction cells, you must clean the reaction
cell rinse nozzles.

u Infectious waste
u Moving parts

d m Cleaning wire (stainless steel, 0.5 mm diameter)
Roche Diagnostics
948 Maintenance as required on the c 701 and c 702 modules

r To unclog the reaction cell rinse

nozzles
1
of the affected reaction cell rinse unit.
A B C D

D Retaining screw
2
2 Insert the cleaning wire into the nozzle tips and run it
through the nozzles.
Roche Diagnostics
3
3 Reattach the reaction cell rinse unit.
4 Repeat steps 1 to 3 for all affected reaction cell rinse

units.
u Related topics

c 701 and c 702 modules
If the corner or bottom of a nozzle tip is worn so that water
remains in the reaction cell, you must replace the nozzle

tip. This occurs typically every 1 or 2 years.
Nozzle tips are found only on reaction cell rinse unit 2.

u Infectious waste
u Moving parts
Video Replacing nozzle tips on reaction cell rinse nozzles

• System time: approximately 2 minutes for (4) Probe
Check; 1:30 minutes for (3) Mechanism Check
(30 cycles)
d m Needle-nose pliers or radio pliers

m Nozzle tips

Roche Diagnostics
r To replace the nozzle tips
1
of reaction cell rinse unit 2.
A B C

2
2 Grip the nozzle tip with pliers and pull it off.
I Be careful not to bend the nozzle.
A Nozzle tip
3
3 Attach a new nozzle tip by hand and align it with the
guide bars.
A B C
A Nozzle tip C Reaction cell

B Guide bars
Roche Diagnostics
4
4 Attach the reaction cell rinse unit.
5
5 Make sure that the nozzle tip is correctly aligned with
the reaction cell.
A
B 6 Close the top cover.

A Reaction cell C Incorrect alignment
B Correct alignment
r To check the alignment of the nozzle

tips
1
2
2 Choose the (4) Probe Check option.
Roche Diagnostics
4
5
5 Choose the Rinse 2 option.
7
7 Visually check the alignment of the nozzle tips.
The reaction cell rinse unit can be moved to 3 positions
by pressing the F1 button:
• To move the reaction cell rinse unit to a position
directly above the reaction cells, press F1 once.
• Make sure that the nozzle tips are aligned properly.
• To move the reaction cell rinse unit into the reaction
cells, press F1 again.
• To move the reaction cell rinse unit to the upper
position (home position), press F1 again.

• To terminate the probe check, choose the Cancel
Maintenance button.
8
8 To check the movement of the mechanical
components, choose Utility > Maintenance > Check.
9
11
11 To select only particular modules, clear the SU check
box.
12

I All mechanisms of the selected module operate.
Roche Diagnostics
14 Make sure that the nozzle tips descend into the center
of the reaction cells.
f After the mechanism check, the instrument returns
instrument alarm will be issued.
u Related topics
Draining the vacuum tank of the c 701 and c 702 modules


representative.

u Infectious waste
d m Beaker

Roche Diagnostics
r To drain the vacuum tank
1
2
2 Locate the drain tubing of the vacuum tank.
A B B
A Vacuum tank (behind cover)

B Drain tubing of vacuum tank
3
3 Detach the upper caps of the drain tubing.
5 Reattach the caps to secure the drain tubing.

regulations.
u Related topics
Roche Diagnostics
Replacing the pipetter probes of the c 701 and c 702

modules
If sample and reagent probes are bent or otherwise
damaged, you must replace them.
Detaching a sample or reagent probe of the c 701 and c 702 modules

To replace the sample or reagent probe or to eliminate
clogging, you must remove the probe first.

A B C D
A Sample probe B C Reagent probe disk A
B Sample probe A D Reagent probe disk B

u Infectious waste
u Moving parts
Videos • Detaching a sample probe

• Detaching a reagent probe
n Approximately 4 minutes per pipetter probe

Roche Diagnostics
r To detach a sample or reagent probe
1
1 If you want to replace the sample probes, do the
following:
• Open the rear cover of the module.
• Remove the plexiglass cover.
A Plexiglass cover
2
2 If you want to replace the reagent probes, open the top
cover of the module.
3
arm cover releases on either side and gently lifting the
cover.
I When detaching the tubing, water flows out of the
tip of the sample probe. Be sure to work above the
rinse station.
Roche Diagnostics
4
4 Unscrew the tubing from the probe.
A Tubing
5

A B
A Retaining nut B Probe seal
6
Roche Diagnostics
7
7 Lift the probe from the pipetter arm.
u Related topics
Reattaching a sample or reagent probe of the c 701 and c 702 modules

After having removed the sample or reagent probe to
replace or eliminate clogging, you must then reattach the
probe.

u Infectious waste
u Moving parts
Videos • Reattaching a sample probe

• Reattaching a reagent probe
d m Sample or reagent probes (in case replacement is

required)

Roche Diagnostics
r To reattach the sample or reagent

probe
1
1 Insert the probe into the pipetter arm.
2

A
3
3 Reattach the probe to the tubing:
• Make sure that the probe seal is in place.
• Do not reuse the old probe seal.
A Probe seal
Roche Diagnostics
4
4 Reattach the pipetter arm cover; the rear section first
and then the front section.
A Pipetter arm cover
5
5 If you have replaced the sample probes, reattach the
plexiglass cover above the sample probes.

8 Check the sample probe.
A Plexiglass cover
Checking the sample and reagent probes of the c 701 and c 702 modules
To ensure that the sample and reagent probes are not
clogged, aligned correctly and that there are no leakages
in the tubing, you must carry out various maintenance
checks.

u Moving parts
n • Operator time: approximately 4 minutes per pipetter

probe
Check; 2 minutes for (6) Air Purge; 2 minutes for
(3) Mechanism Check (30 cycles)

Roche Diagnostics
r To check the tubing system for

leakage
1
1 Remove the plexiglass cover.
A Plexiglass cover
2
2 Detach the pipetter arm covers of the pipetters.

3
3 Visually check for any water leakage from the tubing
connection inside and around the pipetter arms.
A
• If there is a leak, wipe it up and reattach the
B retaining nut.
• Start up the instrument and check again.
• Reattach the pipetter arm covers.
A Tubing B Retaining nut
Roche Diagnostics

a probe
1
1 Make sure that all covers monitored by the interlock
function are closed.
2
3
5
5 Select the module.
6
6 Select the probe that needs to be checked.
I During and at the completion of probe check mode,
be careful not to come in contact with a moving
probe.
Roche Diagnostics
8
8 To move the probe horizontally, press the F1 button.
9 Move the probe by pressing repeatedly the F1 button.
10 Verify the positional accuracy at each stop.

I The correct alignment of the probe is critical for
proper functioning of the instrument. If you are
having problems with alignment of the probe, we
recommend that you contact your Roche Service
representative.
11 If necessary, firmly hold the pipetter arm and gently

bend the probe over its entire length in an arc to
manually adjust the position.

operation of the probes

1
2
4
5

f The air purge is performed with the corresponding
pipetter. At the rinse station, water as well as any air
which may have become trapped are discharged.
Roche Diagnostics
7
7 With the plexiglass cover closed, visually check that
water is dispensed from the tip of the probe in a
straight flow.
I If the flow is not straight, the probe may be clogged.
1
2
4
check box.
5

7 Make sure that the following conditions are maintained:

• The probes descend into the center of the reaction
cells.
• The probes do not touch any other parts.
• At the rinse stations, the outside of each probe is
rinsed with water.
instrument alarm will be issued.
Roche Diagnostics
u Related topics
• Detaching a sample or reagent probe of the c 701 and
c 702 modules (955)
Eliminating clogging of pipetter probes of the c 701 and

c 702 modules
To eliminate clogging, you must clean the probes. Replace
a reagent or sample probe when it is bent or otherwise
damaged.
You can first try to wash the sample probe with the
maintenance action (18) Sample Probe Wash. If the sample
probe is still clogged, you must eliminate clogging with the
cleaning wire.

u Infectious waste
u Moving parts
Videos • Eliminating clogging of sample probes

• Eliminating clogging of reagent probes

• System time: approximately 6 minutes for (18) Sample
Probe Wash
d m Sample or reagent probes (in case replacement is

required)
m Cleaning wire (stainless steel, 0.2 mm and 0.5 mm
diameter for sample and reagent probes respectively)
m Lint-free cloth
m Deionized water

Roche Diagnostics
1
2
4

I If sample aspiration errors occur frequently or if an
is not reset after performing a sample probe wash,
you must eliminate clogging of the sample probe.
f The inside of the sample probe is washed with

1 Detach the pipetter probe.
2
through the probe.

water.
4 Wipe the probe with lint-free cloth.
5 Reattach the sample probe.
6 Check the sample probe.
A u Related topics
A Cleaning wire • Detaching a sample or reagent probe of the c 701 and
c 702 modules (955)
• Reattaching a sample or reagent probe of the c 701
Roche Diagnostics
Cleaning the surface of the c 701 and c 702 modules


cleaning.


u Moving parts

m Disposable lint-free cloth or paper towels
m Deionized water

r To clean module surface
1

u Related topics
Roche Diagnostics
Cleaning the cap waste box on the c 702 module

To ensure no contamination in the cap waste box for
reagent caps, clean the entire cap waste box.

d m Paper towels

r To clean the cap waste box
1
1 Choose Overview.
2
2 Choose the Reagent Manager Overview button .
Roche Diagnostics
3
3 Make sure that there are no reagent cassettes in the
buffer rotor.
4 If the buffer rotor is not empty, do one of the following:

• Manually control reagent cassettes on the buffer
rotor.
• Unload reagent cassettes from the reagent
manager buffer rotor.
5
5 Take out the cap waste box from the compartment.
Empty the container if necessary.
6 Rinse the cap waste box completely with tap water.
7 Dry the cap waste box with paper towels.

8 Return the cap waste box back in place.
A Cap waste box
9
9 If you have emptied the cap waste box, choose the
Waste Box Reset button in the Reagent Manager
Overview work area.
10 Unmask the module if it was masked.
u Related topics
Roche Diagnostics
Cleaning the reagent cassette gripper on the c 702

module
To ensure that the bottom side of the reagent cassette
gripper remains free of reagent splashes, you must clean
the bottom side of the reagent cassette gripper.

u Moving parts
d m Cotton swabs
m Deionized water
j
m The instrument is in manual cleaning (Maintenance

mode).
mode) (783)
r To clean the bottom side of the

reagent cassette gripper
1 Move the reagent cassette gripper with your hand to an

accessible position.
2
2 Clean the bottom side of the reagent cassette gripper
thoroughly with cotton swabs moistened with deionized
water.
I Be careful as there are sharp edges at the bottom
side of the reagent cassette gripper.

I If the reagent cassette gripper is not moved to the
leftmost or rightmost position, the module will not
resume operation and an alarm will be issued.
A
A Bottom side of reagent cassette gripper
Roche Diagnostics
u Related topics
• Checking the reagent cassette gripper on the c 702
module (917)
Roche Diagnostics
972
15 Maintenance of the c 701 and c 702 modules Maintenance as required on the c 701 and c 702 modules
Roche Diagnostics
973
Table of contents
Maintenance of the c 502 module 16
In this chapter 16
List of maintenance actions on the c 502 module . . . 975
Daily maintenance of the c 502 module . . . . . . . . . . . . 977
operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 977
Cleaning the pipetter probes of the c 502 module 980
Cleaning the reaction cell rinse nozzles of the
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 982
Weekly maintenance of the c 502 module . . . . . . . . . . 984
Washing the reaction parts of the c 502 module . 984
Cleaning the reaction cell covers of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 986
Cleaning the rinse stations of the c 502 module . 988
Monthly maintenance of the c 502 module . . . . . . . . . 991
incubation bath of the c 502 module . . . . . . . . . . . 991
Preparing the incubator bath cleaning of the
16 Maintenance of the c 502 module

c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 991
Removing the reaction cells of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 993
Cleaning the incubation bath of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 995
Reinstalling the reaction cells of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 997
Completing the incubator bath cleaning of the
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 999
incubation bath of the c 502 module with the
instrument powered off. . . . . . . . . . . . . . . . . . . . . . . 1001
Cleaning the aspiration filters of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1004
Cleaning the filters behind the front doors of the
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1007
Quarterly maintenance of the c 502 module. . . . . . . . 1009
Cleaning the ultrasonic mixers of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1009
Every 6 months maintenance of the c 502 module . . 1013
Replacing the photometer lamp of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1013
Roche Diagnostics
974
Table of contents
Maintenance as required on the c 502 module . . . . . . 1019

Eliminating clogging of the reaction cell rinse
nozzles of the c 502 module . . . . . . . . . . . . . . . . . . 1019
Draining the vacuum tank of the c 502 module. . . 1020
Cleaning the inside of the pipetter probes of the
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1022
Eliminating clogging of pipetter probes of the
c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1023
Cleaning the module surfaces . . . . . . . . . . . . . . . . . 1025
Maintenance as required on the c 502 module (with
interlock release tool) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1027
Replacing nozzle tips on reaction cell rinse
nozzles of the c 502 module . . . . . . . . . . . . . . . . . . 1027
Replacing the pipetter probes of the c 502
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1033
Detaching a sample, EcoTergent, or reagent
probe of the c 502 module. . . . . . . . . . . . . . . . . 1033
Reattaching a sample, EcoTergent, or reagent
probe of the c 502 module. . . . . . . . . . . . . . . . . 1038
Checking the sample, EcoTergent, and
reagent probes of the c 502 module . . . . . . . . 1041
Roche Diagnostics
List of maintenance actions on the c 502 module 975
List of maintenance actions on the c 502

module
table.


PO Powered off
SB Standby mode

Daily Washing with the wash rack during continuous operation (977) - (1)
Cleaning the pipetter probes of the c 502 module (980) MC/PO
and then
Checking the sample, EcoTergent, and reagent probes of the
c 502 module (1041)
Cleaning the reaction cell rinse nozzles of the c 502 SB/MM/PO
module (982)
Weekly Washing the reaction parts of the c 502 module (984) SB/MM
Cleaning the reaction cell covers of the c 502 module (986) SB/MM/PO
Cleaning the rinse stations of the c 502 module (988) MC/PO
Monthly Replacing reaction cells and cleaning the incubation bath of SB
Replacing reaction cells and cleaning the incubation bath of PO
the c 502 module with the instrument powered off (1001)
Cleaning the aspiration filters of the c 502 module (1004) SB/MM/PO
Cleaning the filters behind the front doors of the c 502 SB/MM/PO
module (1007)
Quarterly Cleaning the ultrasonic mixers of the c 502 module (1009) PO/SB/MM
Every 6 months Replacing the photometer lamp of the c 502 module (1013) (2) SB/MM
(PO required during this
maintenance action)
Roche Diagnostics
976 List of maintenance actions on the c 502 module

As required Eliminating clogging of the reaction cell rinse nozzles of the SB/MM/PO
c 502 module (1019)
Draining the vacuum tank of the c 502 module (1020) SB/MM/PO
Cleaning the inside of the pipetter probes of the c 502 PO
module (1022)
Eliminating clogging of pipetter probes of the c 502 PO
module (1023)
Cleaning the module surfaces (1025) SB/MM/PO
As required (with Replacing nozzle tips on reaction cell rinse nozzles of the SB/MM/PO
interlock release tool) c 502 module (1027)
Replacing the pipetter probes of the c 502 module (1033) PO
(1) From any operating mode such as Standby or Rack Reception mode, or within a maintenance pipe.
(2) Or if the photometer check value exceeds 14 000 absorbance units or when used for more than 750 hours of power-on time.
u Related topics
Roche Diagnostics
Daily maintenance of the c 502 module 977
Daily maintenance of the c 502 module

You must perform these maintenance actions every day.
Contamination of flow paths or pipetter probes may cause

incorrect measurement results or clogging. Therefore,
regularly perform the stated maintenance actions.
In this section
operation (977)
Cleaning the pipetter probes of the c 502 module (980)
Cleaning the reaction cell rinse nozzles of the c 502
module (982)



pipe.

A full calibration of the ISE tests is required after the

washing procedure.
Roche Diagnostics
978 Daily maintenance of the c 502 module

wash rack.
• During the washing procedure, ISE tests must be
masked (P.Mask). Only photometric and immunology
tests can be processed. Do not load any samples with
ISE requests. If you load samples with ISE requests, the
ISE requests cannot be processed until ISE tests are
unmasked again.
operation (843)
Only 300 µL are required for an ISE module with 1

detection unit.
containers.
volume of Sample Cup).
Roche Diagnostics

modules)
m SysClean
m Activator

1
1 Place sample tubes or cups into rack positions 1 to 3 on
a wash rack.
A 2 Pipette suitable amounts of the system reagents into

B the sample tubes.
C
containers.

as instructed.


Roche Diagnostics
r To wash with wash rack during

operation
2
1

displayed.

I After processing the wash rack, all ISE tests must be
results for ISE.

buffer on the same magazine: Wash rack, calibrator
rack containing the ISE calibrators, QC rack containing
the QC materials for ISE tests. To start the washing
procedure, choose Start > Start.

u Related topics
operation (843)
Cleaning the pipetter probes of the c 502 module

To ensure optimal condition of all probes and
measurement accuracy of the module, you must clean the
outside of the reagent probe and sample probe.
q The c 502 module has an interlock cover that allows

the probes to be moved for cleaning when the top cover is
opened.
Roche Diagnostics
q Do not bend or damage the lower end of the probes

during cleaning. Move the pipetter arm gently. Do not move
it up or down.

u Moving parts
u Fire and burns
operation

d m Alcohol
m Lint-free cloth
m Paper towels
j m The instrument is in manual cleaning mode.


r To clean the outside of the sample
and reagent probes
1
I As the interlock function monitors the top cover,
alarms are issued.
2 Move the sample and reagent probes to an accessible

position.
Roche Diagnostics
3
4
3 Wipe the outside of the sample and reagent probe with
a lint-free cloth moistened with alcohol:
the other.
damaged.
4
4 Wipe the inside of the shield pipe using a lint-free cloth
damaged.
5 Close all covers.
u Related topics
• Cleaning the inside of the pipetter probes of the c 502
module (1022)
A
A Shield pipe
Cleaning the reaction cell rinse nozzles of the c 502

module
To ensure accurate results and no water overflow from
reaction cells, you must clean the reaction cell rinse
nozzles. Regular cleaning prevents contamination, crystal
formation, and clogging.
Replace a nozzle tip if a corner or its bottom is worn.

u Replacing nozzle tips on reaction cell rinse nozzles of

u Infectious waste
u Moving parts
operation
Roche Diagnostics

d m Deionized water
m Lint-free cloth

r To clean the reaction cell rinse

nozzles
1
1 Move the reaction cell rinse unit to an accessible
position by loosening the retaining screw.

A B
A Retaining screw B Reaction cell rinse unit
2
2 Wipe the nozzles in a downward motion with a lint-free
3 Put the reaction cell rinse unit back in place and fasten
the retaining screw.
u Related topics
Roche Diagnostics
984 Weekly maintenance of the c 502 module
Weekly maintenance of the c 502 module

In this section
Washing the reaction parts of the c 502 module (984)
Cleaning the reaction cell covers of the c 502
module (986)
Cleaning the rinse stations of the c 502 module (988)
Washing the reaction parts of the c 502 module

To prevent contamination of the reaction cells or the liquid
waste flow path, you must wash the reagent probes and
reaction cells.

u Infectious waste
u Moving parts
operation

• System time: approximately 27 minutes for (7) Wash
Reaction Parts plus 15 minutes for (4) Cell Blank
Measurement
d m NaOHD reagent cassettes (58 mL per module)

m SmpCln1 (approx. 1 mL)

r To wash the reaction parts
1
Roche Diagnostics
Weekly maintenance of the c 502 module 985
2
4

f The maintenance action is finished when the module
r To perform a cell blank measurement
1
2

4
r To view the cell blank test results

2 Check if any cells are listed in the Abnormal Cell List

report:
Roche Diagnostics
u Related topics
bath of the c 502 module (991)
bath of the c 502 module with the instrument powered
off (1001)
Cleaning the reaction cell covers of the c 502 module

To ensure that the reaction cell covers remain free of
reagent and reaction mixture, you must clean them as well
as the ultrasonic mixer covers.

u Infectious waste
u Moving parts
u Fire and burns
operation
! CAUTION
Personal injury due to square shape on the cell

covers
The square shape may lead to personal injury during
replacing or cleaning.
r Be careful not to be hurt by the square shape of cell
covers.
r Take extra care when unscrewing the screws and
removing the cell cover above the ultrasonic mixers.
d m Cotton swabs
m Lint-free cloth
m Alcohol
m Deionized water

Roche Diagnostics
r To clean the reaction cell covers
1
alarms are issued.
2
2 Remove the reaction cell cover above the ultrasonic
mixers by unscrewing and removing the retaining
screws.

3
3 Wipe the front and rear of all reaction cell covers using
I Take care not to splash alcohol into the reaction
cells.
damaged.
4 Put the reaction cell covers back in place.
u Related topics
Roche Diagnostics
Cleaning the rinse stations of the c 502 module

the rinse station, you must clean the rinse stations of the
sample and reagent probes.

u Infectious waste
u Moving parts
u Fire and burns
operation

d m Wash bottle
m Cotton swabs
m Alcohol
m 2% ECO-D solution
m Deionized water

mode) (783)
1
alarms are issued.
Roche Diagnostics
2
2 Move the pipetter probes to positions that leave the
rinse stations easily accessible.
A B
A Rinse station B Sample probe
3
surface.

4
4 Clean the inside of the rinse stations using cotton
swabs moistened with 2% ECO-D solution.
Roche Diagnostics
5
5 Inject about 10 mL of 2% ECO-D solution into each
rinse station.

station.
7
7 Wipe the drying cylinder in the sample probe rinse
station using a cotton swab moistened with alcohol.
8 Return the sample and reagent probes to their original

positions.
10 If instrument was in manual cleaning (Maintenance

mode), terminate manual cleaning (Maintenance mode).
u Related topics
Roche Diagnostics
Monthly maintenance of the c 502 module 991
Monthly maintenance of the c 502 module

In this section
of the c 502 module (991)
of the c 502 module with the instrument powered
off (1001)
Cleaning the aspiration filters of the c 502 module (1004)
module (1007)

of the c 502 module
To ensure the reproducibility of test results, you must
replace the reaction cells and clean the incubation bath.
Preparing the incubator bath cleaning of the c 502 module

To replace the reaction cells and clean the incubation
bath, you must first perform the maintenance action
(10) Incubator Bath Cleaning.
The incubation bath can only be cleaned on 1 module type

at a time. Therefore select either c 701/c 702 modules or
c 502 modules.

u Infectious waste
u Moving parts
u Spilled sample
operation
Roche Diagnostics
992 Monthly maintenance of the c 502 module
! WARNING

r To perform incubator bath cleaning
1
1 In Reagent > Status check the remaining volume of
ECO-D.
2
3
5

f The water is drained from the incubation bath.
7 Wait until the Continue button is active (black) before

starting with the next procedure.
Roche Diagnostics
Removing the reaction cells of the c 502 module

To clean the incubation bath, you must first remove the
reaction cells.

u Infectious waste
u Moving parts
u Spilled sample
operation
! CAUTION
covers
covers.


r To remove the reaction cells
1
alarms are issued.
Roche Diagnostics
2
2 Remove all reaction cell covers.
A B B B
A Reaction cell rinse unit B Reaction cell covers
3
3 Remove the reaction cell rinse unit.
4
4 Remove the complete reaction disk by loosening the
retaining nut.
I Take care that the reaction disk stays upright and
that reaction cells do not get scratched.
A B
A Retaining nut
B Reaction disk
Roche Diagnostics
5
5 Remove the reaction cells that are to be discarded
from the reaction disk.
I Do not touch the surfaces of reaction cells that will
be used again.
6 Discard the used reaction cells.
A Reaction cells
Cleaning the incubation bath of the c 502 module

Before inserting the new reaction cells, you must clean the
incubation bath.

u Infectious waste
u Moving parts

u Spilled sample
operation
d m Deionized water
m 2% ECO-D
m Cotton swabs
m Lint-free cloth

Roche Diagnostics
1
1 Wipe the inner surfaces of the incubation bath with a
clean lint-free cloth.
2 Wipe the indented parts near the ultrasonic mixers with

a cotton swab.
A B
A Inner surface of incubation bath

B Indented parts near ultrasonic mixers
3
3 Carefully wipe the photometer windows using a clean
lint-free cloth (or a cotton swab) moistened with
deionized water.
I Do not scratch the photometer windows when
cleaning. Use only lint-free cloth immersed in
deionized water.
4
4 Remove the drain filter of the incubation bath by
grasping it with the filter removal tool.
5 Clean and rinse the filter with deionized water and

return it to its place.
Roche Diagnostics
Reinstalling the reaction cells of the c 502 module

After having cleaned the incubation bath, you must
reinstall the reaction cells.

u Infectious waste
u Moving parts
u Spilled sample
operation
! CAUTION
covers
covers.

n Approximately 10-15 minutes
d m Reaction cells

Roche Diagnostics
r To reinstall the reaction cells
1
1 Reinstall the reaction disk back into the analyzer.
A Reaction cells
2
2 Insert all reaction cells segments onto the reaction
disk.
3
3 Rotate the reaction disk by hand.
I Make sure that the bottoms of the reaction cells do
not touch the incubation bath drain filter.
5 Return the reaction cell rinse unit ensuring that the

reaction cell rinse unit is correctly aligned.
Roche Diagnostics
Completing the incubator bath cleaning of the c 502 module

After having reinstalled the reaction cells, you must
complete incubator bath cleaning.
Consumption of ECO-D The following table shows the consumption of ECO-D and
the time required for exchanging the incubation bath water
depending upon the setting of the exchange rate.
You can select the water exchange rate on Utility > System
> Analyzer Settings. To select the low water exchange rate,
you must clear the Incubation Water Exchange check box.
Only if the water quality is good use low water exchange
rate.
High exchange rate (long mode) Low exchange rate (short mode)
Consumption of ECO-D (approx.) 8 mL 4 mL
Runtime (approx.) 19 min 5 min
y High exchange rate vs. low exchange rate

u Infectious waste
u Moving parts
u Spilled sample

operation
! WARNING
n Approximately 5-20 minutes for refilling the incubation

bath (depending on module and water exchange rate),
27 minutes for (7) Wash Reaction Parts, 15 minutes for
d m ECO-D (see table above for consumption)

m Deionized water
Roche Diagnostics
1 Choose the Continue button.

f The incubation bath is filled with water again and
ECO-D is added. The instrument then returns to
Standby mode.
2
3
5

7


Cell List report:
u Related topics
• Washing the reaction parts of the c 502 module (984)
Roche Diagnostics

of the c 502 module with the instrument powered off
As an alternative to cleaning the incubation bath in
Standby mode, you can also clean the incubation bath
while the instrument is powered off.

u Infectious waste
u Moving parts
u Spilled sample
operation
! WARNING


• System time: Approximately 2 minutes for draining the
incubation bath, 6 minutes for (5) Incubation Water
Exchange and 15 minutes for (4) Cell Blank
Measurement
d m ECO-D
m Cotton swabs
m Lint-free cloth
m Deionized water or 2% ECO-D solution

Roche Diagnostics
r To drain the incubation bath
1
1 Turn the incubation bath drain tap, located at the rear
of the module, to the DRAIN position and drain the
incubation bath.
• Do not let all the water drain.
• Leave a small amount of water to just cover the
bottom of the incubation bath.
2 To stop draining, turn the incubation bath drain tap

back to its OPERATION position.
A Incubation bath drain tap
1 Remove all the reaction cells.
2 Clean the incubation bath.
3 Reinstall the reaction cells.

1 Gradually pour about 500 mL of deionized water into

2
3 3 Choose the (5) Incubation Water Exchange option.
4 Choose the Select option.
5
Roche Diagnostics
7
8
9
11

13


Cell List report:
Roche Diagnostics
u Related topics
• Removing the reaction cells of the c 502 module (993)
• Cleaning the incubation bath of the c 502 module (995)
• Reinstalling the reaction cells of the c 502
module (997)
Cleaning the aspiration filters of the c 502 module

To prevent clogging of the aspiration filters which may lead
to insufficient reaction cell cleaning, you must clean the
aspiration filters of the CellCln1 and CellCln2 bottles.

u Infectious waste

• System time: approximately 6 minutes for (9) Cell
Detergent Prime
d m Deionized water
m Paper towels

Roche Diagnostics
r To clean the aspiration filters
1
2
2 Take out the wash solution bottles.
3 Remove the tubing from the wash solution bottles and

unscrew the aspiration filter from the tubing end.

4
4 Clean and rinse the aspiration filter with deionized
water.
Roche Diagnostics
5
5 Screw the aspiration filter onto the tubing end and
place it back into the bottle.
6 Return the bottle.
9
9 If you replaced a wash solution bottle, do the following:
• Choose Reagent > Status.
• Choose the Reagent Volume Reset button.
r To perform a cell detergent prime
1
2 2 Choose the (9) Cell Detergent Prime option.
4
5 To specify which line is to be primed, choose an option.

I The Detergent 1 option corresponds to CellCln1
(basic). The Detergent 2 option corresponds to
CellCln2 (acid).
Roche Diagnostics

I The maintenance action is finished when the module

module
To prevent dust or dirt accumulating in the filters leading
to faulty temperature control of the instrument, you must
clean the filters.
d m Paper towels
m Water for rinsing
m Vacuum cleaner


r To clean the filters behind the front
doors
1
Roche Diagnostics
2
2 Remove the circuit board rack filter (A) and the power
supply filter (B).
A B C
A Circuit board rack filter

B Power supply filter
C Cooling unit filter
3
3 CAUTION! Burns due to contact with the radiator
behind the cooling unit filter.
Avoid touching the radiator when removing the cooling
unit filter.
3 Remove the cooling unit filter by pulling it forward from
the filter retaining bracket.
4 Vacuum all filters.
5 If a filter is visibly contaminated, rinse it with water and

blot dry with paper towels.
A B
6 Reinstall all filters.
B Filter retaining bracket 7 Close the front doors of the module.
u Related topics
Roche Diagnostics
Quarterly maintenance of the c 502 module 1009
Quarterly maintenance of the c 502 module

3 months.
In this section
Cleaning the ultrasonic mixers of the c 502 module (1009)
Cleaning the ultrasonic mixers of the c 502 module

To prevent contamination and precipitation on the surface
of the ultrasonic mixers leading to inaccurate results, you
must clean the ultrasonic mixers.

u Electric shock
u Infectious waste
u Moving parts
operation
CAUTION

!

covers
covers.

incubation bath; 18 minutes for refilling the incubation
bath; 3 minutes for (9) Cuvette Mixing check
d m 2% ECO-D solution
m Deionized water
m Cotton swabs
Roche Diagnostics
1010 Quarterly maintenance of the c 502 module

r To clean the surface of the ultrasonic

mixer
1
2
4

f The water drains from the incubation bath.
f A confirmation window appears.
6 Wait until the Continue button is active (black).

alarms are issued.
8
8 Remove the reaction cell cover above the ultrasonic
mixers by unscrewing and removing the retaining
screws.
9 Remove the reaction cells near the ultrasonic mixers (at

least 3 reaction cell segments).
I Do not to touch the surfaces of reaction cells.
Roche Diagnostics
Quarterly maintenance of the c 502 module 1011
10
11
11 Carefully wipe the surface of the ultrasonic mixers
using cotton swabs moistened with 2% ECO-D solution.
12 Wipe off the wash solution using cotton swabs

13 Return the removed sections of reaction cells to the

same positions.
I If the reaction cells are not returned to the same
positions, then a cell blank measurement must be
performed.
14 Return the reaction cell cover.

16 To terminate incubator bath cleaning, choose the
Continue button.
r To check the intensity of the

ultrasonic output
1
2
2 Choose the (9) Cuvette Mixing option.
Roche Diagnostics
1012 Quarterly maintenance of the c 502 module
4
5
5 Clear the With Cell Wash check box.
I If selected, it would rinse all reaction cells prior to
the check.

Roche Diagnostics
Every 6 months maintenance of the c 502 module 1013
Every 6 months maintenance of the c 502

module
6 months.
In this section
Replacing the photometer lamp of the c 502
module (1013)
Replacing the photometer lamp of the c 502 module

To ensure reproducibility of measurement, you must
replace the photometer lamp.
We recommend combining this maintenance action with

the monthly cleaning of the incubation bath.

u Infectious waste
u Moving parts

u Fire and burns
operation
! CAUTION
covers
covers.
c If the photometer lamp has been used for more than

6 months (or 750 hours of power-on time) or if the
photometer check value exceeds 14 000 absorbance
units.
The total power-on time is displayed on the cumulative
operation list. You can view this list via Print > Utility
> Cumulative Operation List.
Roche Diagnostics
1014 Every 6 months maintenance of the c 502 module

• System time: approximately 3 minutes for
(3) Photometer Check; 30 minutes waiting for lamp to
cool down; 30 minutes waiting for lamp stabilization;
d m Alcohol
m Lint-free cloth
m Photometer lamp

r To check the light intensity
1
2
2 Choose the (3) Photometer Check option.

4

f Water is injected from the rinsing mechanism into
reaction cell no. 1 and the absorbance of the water
is measured for each available wavelength.
6 Choose Print > History.
7 Choose the Photometer Check report.
Roche Diagnostics
8 Check the absorbance values in the photometer check

report.
If the readings exceed 14 000 absorbance units at
340 nm, or if the readings are different from the
previous one, do the following:
• Verify that the reaction cells, the incubation bath,
and the photometer windows are free of
• Verify that the reaction cells are not scratched or
cracked. Verify that the reaction cells are at least
half filled with water.
• If the results do not improve, replace the
photometer lamp.
r To remove the photometer lamp
1
2 2 Choose the (13) Change Photometer Lamp option.

4

f The power supply to the photometer lamp is
switched off during the execution of the
maintenance action (13) Change Photometer Lamp.
6 CAUTION! Burns due to hot surface of the photometer

lamp unit.
Check that the photometer lamp unit has cooled down
before replacing the lamp.
6 Wait about 30 minutes for the photometer lamp and
lamp housing to cool down.

alarms are issued.
Roche Diagnostics
8
8 Remove the reaction cell rinse unit.
9 Lift up or remove all reaction cell covers.
10
10 Remove the reaction disk including the reaction cells
from the module by loosening the retaining nut.
I Take care not to touch the optical surfaces. An
alarm is issued if water drops adhering to the
outside of the reaction cells drip onto components.
A B
A Retaining nut B Reaction disk
11
11 Loosen the photometer lamp cable from the cable clip.
12 Rotate the connector cover and disconnect the

connector of the photometer lamp cable.
13 Take out the photometer lamp by loosening both

retaining screws.
14 Remove the retaining screws from the photometer

lamp.
I The retaining screws are used to install a new
photometer lamp.
A B B C D E
A Photometer housing D Connector

B Retaining screws E Connector cover
C Cable clip
Roche Diagnostics
r To install a new photometer lamp
1
1 Insert the retaining screws from the old photometer
lamp into the new photometer lamp.
2 Insert the new photometer lamp:

A • Align the pin hole in the photometer lamp base with
B the guide pin of the photometer lamp housing.
• Tighten the 2 photometer lamp retaining screws.
C
I Be careful not to touch the glass part of the new
photometer lamp. If you do touch the glass, wipe it
D
off with a lint-free cloth moistened with alcohol.
A Guide pin C Retaining screws

B Pin hole D Connector
3
3 Plug in the connector and rotate back the connector
cover.
4 Secure the photometer lamp cable with the cable clip.

A B C D
A Photometer lamp cable C Connector

B Cable clip D Connector cover
5
5 Reinstall the reaction disk including reaction cells and
tighten the retaining nut.
A B
A Retaining nut B Reaction disk
Roche Diagnostics
6
6 Reinstall the reaction cell covers.
7 Return the reaction cell rinse unit ensuring that the

reaction cell rinse unit is correctly aligned.
8 Close the covers of the module.
10 Wait about 30 minutes for the photometer lamp to

stabilize.
11
12
I A cell blank measurement is necessary to
compensate for a possible change in light intensity.
14


Cell List report:
u Related topics
• Reinstalling the reaction cells of the c 502
module (997)
Roche Diagnostics
Maintenance as required on the c 502 module 1019
Maintenance as required on the c 502

module
In this section
Draining the vacuum tank of the c 502 module (1020)
Cleaning the inside of the pipetter probes of the c 502
module (1022)
Eliminating clogging of pipetter probes of the c 502
module (1023)
Cleaning the module surfaces (1025)

the c 502 module
If reaction mixture remains in the reaction cells or water
overflows from reaction cells, you must clean the reaction
cell rinse nozzles.

u Infectious waste
u Moving parts
operation

d m Cleaning wire (stainless steel, 0.5 mm diameter)

Roche Diagnostics
1020 Maintenance as required on the c 502 module
r To unclog the reaction cell rinse

nozzles
1
1 Loosen the retaining screw of the reaction cell rinse
unit and lift off the entire unit.
A B
2
2 Insert the cleaning wire into the nozzle tips and run it
through the nozzles.
3 Reattach the reaction cell rinse unit.

u Related topics
Draining the vacuum tank of the c 502 module


representative.

u Infectious waste
Roche Diagnostics
d m Beaker

r To drain the vacuum tank
2
2 Locate the drain tubing of the vacuum tank.
A Drain tubing of vacuum tank

3
3 Detach the upper cap of the drain tubing.
5 Reattach the cap to secure the drain tubing.

regulations.
u Related topics
Roche Diagnostics
Cleaning the inside of the pipetter probes of the c 502

module
To eliminate clogging, you must clean the inside of the
probes. Replace a sample, EcoTergent, or reagent probe if
it is bent or otherwise damaged.
You can first try to wash the sample probe with the
maintenance action (18) Sample Probe Wash. If the sample
probe is still clogged, you must eliminate clogging with a
cleaning wire.
u Eliminating clogging of pipetter probes of the c 502
module (1023)
u Replacing the pipetter probes of the c 502
module (1033)
n • System time: approximately 6 minutes for (18) Sample

Probe Wash

1
2
4

I If sample aspiration errors occur frequently or if an
is not reset after performing a sample probe wash,
you must eliminate clogging of the sample probe.
f The inside of the sample probe is washed with
Roche Diagnostics
Eliminating clogging of pipetter probes of the c 502

module
To eliminate clogging, you must clean the inside of the
probes. Replace a probe if it is bent or otherwise damaged.
q You can first try to wash the sample probe with the
maintenance action sample probe wash. If the sample
probe is still clogged, you must eliminate clogging with the
cleaning wire.
u Cleaning the inside of the pipetter probes of the c 502
module (1022)

u Sharp objects
u Infectious waste
u Moving parts
d m Sample, EcoTergent, or reagent probes (in case

replacement is required)
m Cleaning wire (0.2 mm diameter for sample probe)
m Cleaning wire (0.5 mm diameter for EcoTergent and
reagent probes)
m Lint-free cloth
m Deionized water

Roche Diagnostics
1
1 Open the top cover.
2 2 If you need to eliminate clogging in a sample or

EcoTergent probe, detach the pipetter arm covers of
the pipetters.
3
3 If you need to eliminate clogging in a reagent probe:
• Loosen the knurled counter nut by turning it
counterclockwise.
• Loosen the lower probe retaining nut by turning it
clockwise.
4 Detach the pipetter probe.
Roche Diagnostics
5
through the probe.

water.
7 Wipe the probe with lint-free cloth.
8 Reattach the probe.
9 Check the probe.
A u Related topics
• Detaching a sample, EcoTergent, or reagent probe of
A Cleaning wire
• Reattaching a sample, EcoTergent, or reagent probe of
• Checking the sample, EcoTergent, and reagent probes
Cleaning the module surfaces


cleaning.


u Moving parts
operation

m Deionized water
Roche Diagnostics

r To clean module surfaces
1

u Related topics
Roche Diagnostics
Maintenance as required on the c 502 module (with interlock release tool) 1027
Maintenance as required on the c 502

module (with interlock release tool)
The interlock release tool is used to operate the system
while the top cover is open. You must have received
training for the extended maintenance actions that require
the interlock release tool.
In this section
c 502 module (1027)
Replacing the pipetter probes of the c 502 module (1033)

c 502 module
If a corner or the bottom of a nozzle tip is worn so that
water remains in the reaction cell, you must replace the
nozzle tip, typically every 1 or 2 years.
Observe the following guidelines when using the interlock

release tool in a maintenance task.

• Use the interlock release tool only if you have received
training for the extended maintenance actions that
require this tool.
• Use the interlock release tool only when explicitly
specified in a maintenance action.
• Remove the interlock release tool immediately after
finishing the maintenance action.
• Do not pass on the interlock release tool to operators
who have not been trained.

u Sharp objects
u Infectious waste
u Moving parts

• System time: approximately 1:30 minutes for
d m Needle-nose pliers or radio pliers

m Nozzle tips
Roche Diagnostics
1028 Maintenance as required on the c 502 module (with interlock release tool)

r To deactivate the safety interlock of

the top cover
1
alarms are issued.
2
2 Insert the interlock release tool into the interlock switch
box.
I If the interlock release tool is inserted into the
interlock switch box, the analyzer control does not
detect that the top cover is open.
Roche Diagnostics
3
3 Turn the interlock release tool clockwise by 90°.
I Now the interlock function is deactivated.
r To replace the nozzle tips
1
1 Loosen the retaining screw of the reaction cell rinse
unit and lift off the entire unit.

A B
2
2 Grip the nozzle tip with pliers and pull it off.
I Be careful not to bend the nozzle.
A Nozzle tip
Roche Diagnostics
3
3 Attach new nozzle tips by hand and align them with the
guide bars.
A B C
A Nozzle tip C Reaction cell

B Guide bars
4
4 Attach the reaction cell rinse unit and tighten the
retaining screw.
A B
r To check the alignment of the nozzle

tips
1 Make sure that the nozzle tips are correctly aligned with
1
the reaction cells.
A
A Reaction cell C Incorrect alignment

B Correct alignment
Roche Diagnostics
2
2 To check the movement of the mechanical
components, choose Utility > Maintenance > Check.
3
5
check box.
6

8 Make sure that the nozzle tips descend into the center
of the reaction cells.

r To activate the safety interlock of

the top cover
1
1 Remove the interlock release tool.
Roche Diagnostics
2
2 Close and lock the top cover.
3 Delete any alarms concerning the opened cover.
4
5
7
u Related topics
Roche Diagnostics
Replacing the pipetter probes of the c 502 module

If pipetter probes are bent or otherwise damaged, you
must replace them.
Observe the following guidelines when using the interlock

release tool in a maintenance task.
• Use the interlock release tool only if you have received
training for the extended maintenance actions that
require this tool.
• Use the interlock release tool only when explicitly
specified in a maintenance action.
• Remove the interlock release tool immediately after
finishing the maintenance action.
• Do not pass on the interlock release tool to operators
who have not been trained.
Detaching a sample, EcoTergent, or reagent probe of the c 502 module

To replace the sample, EcoTergent, or reagent probe or to
eliminate clogging, you must remove the probe first.
The replacement of a probe can only be performed by

operators who have been trained for such extended

u Sharp objects
u Infectious waste
u Moving parts

Roche Diagnostics
r To detach a sample or EcoTergent

probe
1
2
arm cover releases on either side and gently lifting the
cover.
I When detaching the tubing, water flows out of the
tip of the sample probe. Be sure to work above the
rinse station.
3
3 Unscrew the tubing from the probe.
A Tubing
Roche Diagnostics
4
A B
A Retaining nut B Probe seal
5

6
Roche Diagnostics
r To detach a reagent probe
1
2
2 Loosen the knurled counter nut by turning it
counterclockwise and the lower probe retaining nut by
turning it clockwise.
3
3 Disconnect the tubing connector of the reagent tubing.
Roche Diagnostics
4
u Related topics
module (1023)
Roche Diagnostics
Reattaching a sample, EcoTergent, or reagent probe of the c 502 module

After having removed a sample, EcoTergent, or reagent
probe in order to replace it or to eliminate clogging, you
must reattach the probe.

u Sharp objects
u Infectious waste
u Moving parts
d m Sample, EcoTergent, or reagent probes (in case

replacement is required)

r To reattach a sample or EcoTergent

probe
1
To avoid sampling problems, ensure that the sample
probe is routed correctly through the foam support.
Roche Diagnostics
2
3
3 Reconnect the probe to the tubing:
• Make sure that the probe seal is in place.
• Do not reuse the old probe seal.

A Probe seal
4
4 Reattach the pipetter arm cover: first the rear section,
then the front section.
7 Check the probe (u 1041).
Roche Diagnostics
r To reattach a reagent probe
1
2
2 Tighten the probe retaining nut by turning it
counterclockwise followed by the knurled counter nut
by turning it clockwise.
3
3 Reconnect the tubing connector of the reagent tubing.
6 Check the reagent probe (u 1041).
u Related topics
module (1023)
Roche Diagnostics
Checking the sample, EcoTergent, and reagent probes of the c 502 module
To ensure that the sample, EcoTergent, and reagent
probes are not clogged, aligned correctly and that there
are no leakages in the tubing, you must carry out various
checking procedures.

u Sharp objects
u Moving parts
n • Operator time: approximately 4 minutes per pipetter

probe
Check; 2 minutes for (6) Air Purge; 2 minutes for

r To deactivate the safety interlock of

the top cover

1
alarms are issued.
Roche Diagnostics
2
2 Insert the interlock release tool into the interlock switch
box.
I If the interlock release tool is inserted into the
interlock switch box, the analyzer control does not
detect that the top cover is open.
3
3 Turn the interlock release tool clockwise by 90°.
I Now the interlock function is deactivated.
r To check the tubing system for

leakage
1 1 If you need to check the tubing of a sample or

EcoTergent probe, detach the pipetter arm covers of
the pipetters.
Roche Diagnostics
2
2 If you need to check the tubing of a reagent probe:
• Loosen the knurled counter nut by turning it
counterclockwise.
• Loosen the lower probe retaining nut by turning it
clockwise.
3 Visually check for any water leakage from the tubing

connection inside and around the pipetter arms.
• If there is a leak, power off the instrument or module
temporarily.
• Wipe up the leaked water and eliminate the leak.
• Start up the instrument and check again.
• Reattach the pipetter arm covers.

a probe
1
2

4
4 WARNING! Infection and injury due to contact with
moving parts. During and at the completion of the
probe check, be careful not to come in contact with a
moving probe.
4 Select the module and the probe to be checked.
Roche Diagnostics
6
6 To move the probe horizontally, press the maintenance
button.
7 Move the probe by pressing repeatedly the

maintenance button.
8 Verify the positional accuracy at each stop.

I The correct alignment of the probe is critical for
proper functioning of the instrument. If you are
having problems with alignment of the probe, we
recommend that you contact your Roche Service
representative.
A 9 If necessary, firmly hold the pipetter arm and gently

A Maintenance button bend the probe over its entire length in an arc to
manually adjust the position.
10 To terminate the probe check, choose the Stop button.

operation of the probes
1
2
4
5

f The air purge is performed with the corresponding
pipetter. At the rinse station, water as well as any air
which may have become trapped are discharged.
Roche Diagnostics
7 Visually check that water is dispensed from the tip of

the probe in a straight flow.
I If the flow is not straight, the probe may be clogged.
1
2
4

5

7 Make sure that the following conditions are maintained:

• The probes descend into the center of the reaction
cells.
• The probes do not touch any other parts.
• At the rinse stations, the outside of each probe is
rinsed with water.
Roche Diagnostics
r To activate the safety interlock of

the top cover
1
1 Remove the interlock release tool.
2
2 Close and lock the top cover.
3 Delete any alarms concerning the opened cover.

4
5
7
Roche Diagnostics
u Related topics
module (1023)
Roche Diagnostics
1048
16 Maintenance of the c 502 module Maintenance as required on the c 502 module (with interlock release tool)
Roche Diagnostics
1049
Table of contents
Maintenance of the e 801 module 17
In this chapter 17
List of maintenance actions on the e 801 module . . . 1051
Daily maintenance of the e 801 module . . . . . . . . . . . . 1053
Cleaning probes and nozzles of the e 801 module 1053
Every 2 weeks maintenance of the e 801 module. . . . 1058
Cleaning ProCell aspiration pipes of the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1058
Cleaning ProCell/CleanCell supply nozzles and
replacing PC/CC cups of the e 801 module. . . . . . 1062
Cleaning the vortex mixers and separation
stations of the e 801 module . . . . . . . . . . . . . . . . . . 1066
Cleaning the incubator disk of the e 801 module . 1070
Cleaning the microbead mixer of the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1072
Cleaning the rinse stations of the e 801 module . 1075
Maintenance as required on the e 801 module . . . . . . 1080
Cleaning the ECL and pre-wash flow paths of the
17 Maintenance of the e 801 module

e 801 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1080
Cleaning CleanCell aspiration pipes and bottle
stand of the e 801 module . . . . . . . . . . . . . . . . . . . . 1087
Cleaning PreClean aspiration pipes and bottle
stands of the e 801 module . . . . . . . . . . . . . . . . . . . 1091
Checking and cleaning the magazine drawer of
the e 801 module. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1095
Cleaning the surface of the e 801 module . . . . . . 1098
Checking and cleaning the cooling unit filter of
the e 801 module. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1100
Roche Diagnostics
1050
Table of contents
Roche Diagnostics
List of maintenance actions on the e 801 module 1051

module
Periodic maintenance ensures that the module works
properly and minimizes the risk of contamination. You must
observe the maintenance intervals in the following table.

u Open cover
The maintenance intervals are independent of the

The instrument mode column lists the required module

mode at the beginning of the maintenance action. That is,
the required module mode can change throughout a
maintenance action.
PO Powered off
SB Standby mode

Daily maintenance Cleaning probes and nozzles of the e 801 module (1053) SB/MM/PO
Every two weeks Cleaning ProCell aspiration pipes of the e 801 module (1058) SB/MM/PO
maintenance Cleaning ProCell/CleanCell supply nozzles and replacing SB/MM
PC/CC cups of the e 801 module (1062)
Cleaning the vortex mixers and separation stations of the SB/MM/PO
e 801 module (1066)
Cleaning the incubator disk of the e 801 module (1070) SB/MM/PO
Cleaning the microbead mixer of the e 801 module (1072) SB/MM/PO
Cleaning the rinse stations of the e 801 module (1075) SB/MM/PO
Maintenance as required Cleaning the ECL and pre-wash flow paths of the e 801 SB/MM/PO
module (1080)
Cleaning CleanCell aspiration pipes and bottle stand of the SB/MM/PO
e 801 module (1087)
Cleaning PreClean aspiration pipes and bottle stands of the SB/MM/PO
e 801 module (1091)
Checking and cleaning the magazine drawer of the e 801 SB/MM/PO
module (1095)
Cleaning the surface of the e 801 module (1098) SB/MM/PO
Checking and cleaning the cooling unit filter of the e 801 SB/MM/PO
module (1100)
y List of maintenance actions of e 801 module
Roche Diagnostics
1052 List of maintenance actions on the e 801 module
u Related topics
Roche Diagnostics
Daily maintenance of the e 801 module

day.
After maintenance, if the instrument will be powered off or

remain in Standby mode for an extended time, you must
perform manual finalization. If you process further
samples, finalization is not necessary.
u Performing manual finalization on cobas e
modules (607)
In this section
Cleaning probes and nozzles of the e 801 module (1053)
Cleaning probes and nozzles of the e 801 module

To ensure that the instrument measures accurately, you
must clean the sample probe, reagent probes, the nozzles
of the pre-wash area, and the ECL sipper nozzles.


u Infectious waste
u Moving parts
u Fire and burns
! WARNING
Incorrect results may occur when parts in the
detection unit are damaged during cleaning or
maintenance
r Do not damage the black LLD wires, the liquid level
sensors, and ECL sipper nozzles.
r If you notice any damages, contact your Roche Service
representative.
d m Alcohol
m Deionized water
m Lint-free cloth
m Paper towels
Roche Diagnostics
1054 Daily maintenance of the e 801 module

r To clean probes and nozzles
1
1 To discharge any static charge which may have built up
on you, do the following:
• Open the cover of the backup operation port at the
module sample buffer.
• Touch a screw inside the backup operation port.
A Screws inside the backup operation port
2
2 WARNING! Incorrect results may occur due to improper
A
cleaning or due to a deformed probe.
Use a new lint-free cloth for each probe to prevent

carryover.
Do not bend or damage the probes during cleaning.
Move the pipetter arm gently. Do not move it up or
down.
Ensure that no cleaning material falls into AssayTips or
AssayCups. Keep the magazine cover closed during
cleaning.
2 Wipe the outside of the sample probe from top to
bottom with a lint-free cloth moistened with deionized
water.
3 If the sample probe still appears dirty, do the following:

A Magazine cover
• Wipe the outside from top to bottom with a lint-free
• Immediately afterwards, wipe the outside from top
to bottom with a lint-free cloth moistened with
deionized water.
damaged.
Roche Diagnostics
4
4 NOTICE Instrument damage when placing or removing
the paper towel. The gap between the reagent
pipetting positions and the reagent pipetters and the
microbead mixer respectively is small. The paper towel
may damage the pipetters or the microbead mixer.
4 To ensure that no object or fluid drops into the reagent
disk, carefully place a paper towel over the reagent
pipetting positions.
5
5 To facilitate maintenance, hold the metal plate of the
reagent pipetting mechanism and move it to the left.
6
6 Clean the outside of the reagent probes:

• Wipe each probe from top to bottom with a lint-free
• Wipe each probe from top to bottom with a lint-free
• After cleaning, perform a visual check to ensure
that none of the reagent probes are damaged.
7
7 To facilitate maintenance, hold the metal plate of the
pre-wash pipetting mechanism and move it to the
separation stations.
Roche Diagnostics
8
8 Clean the outside of the nozzles of the pre-wash area:
• Wipe each nozzle from top to bottom with a lint-free
9
9 Open the cover of the sipper station.
10
10 Clean the outside of the ECL sipper nozzles and liquid
level sensors:
• Wipe both nozzle and liquid level sensor from top to
bottom with a cotton swab moistened with alcohol.
• Wipe both nozzle and liquid level sensor from top to
bottom with a cotton swab moistened with
deionized water.
A B C D
A Channel 1: ECL sipper C Channel 2: ECL sipper
nozzle nozzle
B Channel 1: liquid level D Channel 2: liquid level
sensor sensor
Roche Diagnostics
11
11 Close the cover of the sipper station.

12 Carefully remove the paper towel from the reagent
u Related topics
Roche Diagnostics
1058 Every 2 weeks maintenance of the e 801 module

module
You must perform the following maintenance actions at
least every 2 weeks.
In this section
Cleaning ProCell aspiration pipes of the e 801
module (1058)
Cleaning ProCell/CleanCell supply nozzles and replacing
Cleaning the vortex mixers and separation stations of the
e 801 module (1066)
Cleaning the incubator disk of the e 801 module (1070)
Cleaning the microbead mixer of the e 801 module (1072)
Cleaning the rinse stations of the e 801 module (1075)
Cleaning ProCell aspiration pipes of the e 801 module

To prevent incorrect results, you must clean the ProCell
aspiration pipes.
! WARNING
Touching the aspiration pipes or aspiration filters
may lead to contamination and instability of the
system reagents.
r Do not touch the aspiration pipes or aspiration filters.
r Use a cloth moistened with alcohol if you touched the
aspiration pipes or aspiration filters accidentally.

u Infectious waste
u Moving parts

Roche Diagnostics
Every 2 weeks maintenance of the e 801 module 1059
d m Lint-free cloth
m Caps of ProCell II M bottles
m Paper towels
m Deionized water
m Alcohol

r To clean ProCell aspiration pipes
1
1 Open the front door gently to avoid the formation of

A
A ProCell II M bottles
2
2 Pull up the ProCell aspiration pipes and to the left to
hook them on their respective notches.
I ProCell II M solution may trickle down. Wipe up the
liquid with paper towels or a lint-free cloth.
A B C
A Aspiration pipe C Notch
B Aspiration filter
Roche Diagnostics
3
3 Close the ProCell II M bottles with bottle caps.

interchanged bottles of the same system reagent,
leading to incorrect inventory information.
Before removing the bottles, mark the bottle position
(left/right) on each bottle.
4 Remove the ProCell II M bottles from the module.
5
5 Clean the aspiration pipes:
• Wipe the aspiration pipes with a lint-free cloth
• Let the aspiration pipes dry for 1 minute.
6

bottles.
6 Place the ProCell II M bottles on their original positions
on the bottle stand.
7 Remove the bottle caps from the bottles.
Roche Diagnostics
8
8 Unhook the aspiration pipes and carefully lower them
into the bottles.
f The slider caps close the bottles.
9 To prevent evaporation, make sure that the bottles are

closed properly by the slider caps.

10
11 Perform a reagent prime:
• Choose the (8) Reagent Prime option.
• Select the desired module.
• From the e 801 Prime Item drop-down list, choose
the Reagent option.
• In the Cycles field, enter “1” cycle.

12 If you are not going to process further samples,
perform the maintenance action finalization.
u Related topics
• Performing manual finalization on cobas e
modules (607)
• Cleaning CleanCell aspiration pipes and bottle stand of
Roche Diagnostics

To prevent the accumulation of crystals, you must clean
the ProCell/CleanCell supply nozzles and replace the
PC/CC cups.

u Infectious waste
u Moving parts
! WARNING
maintenance
representative.
Videos • Cleaning ProCell/CleanCell supply nozzles

• Cleaning or replacing PC/CC cups

d m Cotton swabs
m Deionized water
m Four PC/CC cups
m Lint-free cloth

r To empty PC/CC cups
1
Roche Diagnostics
2
4

r To clean ProCell/CleanCell supply

nozzles
1

2
2 Wipe each ProCell/CleanCell supply nozzle with a
cotton swab moistened with deionized water.
A
A ProCell/CleanCell supply nozzles
Roche Diagnostics
r To clean or replace PC/CC cups
1
1 Carefully remove the PC/CC cups from their holders.
A B C D E F
A Channel 1: CC cup D Channel 2: CC cup
B Channel 1: PC cup E Channel 2: PC cup
C Channel 1: SysClean F Channel 2: SysClean
adapter adapter
2
2 Wipe each PC/CC cup holder with a cotton swab
3
3 Wipe each AssayCup holder and the area around the
PC/CC cup holders with a cotton swab moistened with
deionized water.
A AssayCup holder
Roche Diagnostics
4
4 Clean the PC/CC cups:
• Rinse the PC/CC cups with deionized water.
• Dry the PC/CC cups with a dry lint-free cloth.
5
5 Replace the PC/CC cups:
• If the PC/CC cups appear clean, place them in the
cup holders.
• If the PC/CC cups still appear dirty or if they are
otherwise damaged, place new PC/CC cups in the
cup holders. Dispose of the used PC/CC cups
6

8
the Reagent option.
Roche Diagnostics
u Related topics

e 801 module
Spills on the vortex mixers or separation stations can cause
a gripper movement alarm. You must clean the vortex
mixers and separation stations regularly.
NOTICE
Damage to aluminum parts due to the use of acid or
alkaline cleaning solutions
r Do not clean the incubator or the vortex mixers with an
acid or alkaline solution. Such solutions may degrade
the aluminum.
r Use deionized water only to clean aluminum parts.

u Infectious waste
u Moving parts
Video Cleaning the vortex mixers and separation stations
d m Cotton swabs
m Lint-free cloth
m Deionized water
m Paper towels

Roche Diagnostics
r To clean the vortex mixers and

separation stations
1
A Screws inside the backup operation port.
2

I Do not bend or damage the probes during cleaning.
Move the pipetter arm gently.
3
3 To access the pre-wash area, move the reagent
pipetting mechanism to the left.
I Do not move the pipetter arm up or down.
If you accidentally move the arm down, be sure to
move it up to the upper limit position before starting
operation. Additionally, perform the maintenance
action reset.
4 To access the pre-wash area, move the pre-wash

gripper to the right.
5 To access the consumables area, remove the magazine

cover:
• Loosen the retaining screw of the magazine cover.
• Lift the magazine cover and move it to the right.
Roche Diagnostics
6
6 Clean the surfaces of all vortex mixers and separation
stations with a lint-free cloth moistened with deionized
water.
7 If the surfaces of the vortex mixers and separation

stations are still dirty, scrub them gently with the
moistened lint-free cloth.
A B
C
A Pre-wash area: vortex mixers

B Pre-wash area: separation stations
C Consumables area: vortex mixer
Roche Diagnostics
8
8 Clean the openings of the vortex mixers and separation
stations with cotton swabs moistened with deionized
water.
9
9 Dry the vortex mixers and separation stations with a dry
lint-free cloth and cotton swabs.

I Make sure that the surfaces and the openings of the
vortex mixers and separation stations are dry and
not clogged by reagent or sample spills. Otherwise,
an instrument alarm concerning the grippers may be
issued when operation is resumed.
10 Reattach the magazine cover:

• Insert the tenon of the magazine cover into the
mortise.
• Fasten the retaining screw of the magazine cover.
11 Move the pre-wash gripper to the left in its original

position.
12 Move the reagent pipetting mechanism to the right in its

original position.
action reset.
Roche Diagnostics

u Related topics
Cleaning the incubator disk of the e 801 module

To prevent gripper movement alarms, you must clean the
incubator disk.
NOTICE
the aluminum.

u Moving parts
u Infectious waste
Video Cleaning the incubator disk
d m Lint-free cloth
m Cotton swabs
m Deionized water
Roche Diagnostics

r To clean the incubator disk
1
2 To access the consumables area, remove the magazine

cover:
• Loosen the retaining screw of the magazine cover.
• Lift the magazine cover and move it to the right.
3 To access the consumables area, move the magazine

gripper down.
A
4
4 If the incubator cover is dirty, clean the incubator
cover:

• Clean the incubator cover with a lint-free cloth
• If the incubator cover is still dirty, scrub it gently
with the moistened lint-free cloth.
5
5 To clean the top of the incubator disk, do the following:
• Manually rotate the incubator disk.
• Clean the top of the incubator disk with a lint-free
• If the incubator disk appears dirty, scrub it gently
Roche Diagnostics
6
6 Clean each of the 94 positions on the incubator disk
with cotton swabs moistened with deionized water.
7
7 Dry the incubator disk with a dry lint-free cloth and
cotton swabs.
I Make sure that the incubator disk and its positions
are dry and not clogged by reagent or sample spills.
Otherwise, an instrument alarm concerning the
grippers may be issued when operation is resumed.
8 Move the magazine gripper up in its original position.
9 Reattach the magazine cover:

• Insert the tenon of the magazine cover into the
mortise.
• Fasten the retaining screw of the magazine cover.

u Related topics
Cleaning the microbead mixer of the e 801 module

To prevent incorrect results, you must clean the microbead
mixer.

u Infectious waste
u Moving parts
u Fire and burns
Video Cleaning the microbead mixer
Roche Diagnostics
d m Lint-free cloth
m Alcohol
m Deionized water
m Small brush
m Paper towels

r To clean the microbead mixer
1

A
2
Roche Diagnostics
3
3 To facilitate maintenance, move the microbead mixer
mechanism to the right by pushing the metal plate.
4
4 Carefully wipe the microbead mixer paddle from top to
bottom with a lint-free cloth moistened with alcohol.
I Ensure that the microbead mixer paddle is not
damaged.
damaged.
5
5 Clean the 4 propeller blades with a brush moistened
with alcohol.
6 Repeat steps 4 to 5 with deionized water instead of

alcohol.
7 Move the microbead mixer mechanism to the left in its

original position.

Roche Diagnostics
r To check the microbead mixer
1
2
2 Choose the (14) Bead Mixer Check option.
4
5 Enter “1” cycle.
7 During bead mixer check, check for abnormal sound

caused by mechanical interference of a bent or
damaged microbead mixer.
8 If an instrument alarm occurs, contact your Roche


u Related topics
Cleaning the rinse stations of the e 801 module

To prevent contamination, you must clean the rinse
stations of the reagent probes, the microbead mixer, and
the ECL sipper nozzles.

u Infectious waste
u Moving parts
u Fire and burns
Roche Diagnostics
! WARNING
maintenance
representative.
Videos • Cleaning the rinse stations part 1

• Cleaning the rinse stations part 2
d m Cotton swabs
m Alcohol
m 2% ECO-D solution
m Deionized water
m 50 mL syringe with tubing or wash bottle
m Paper towels


1
Roche Diagnostics
2
3
3 To facilitate maintenance, move the reagent pipetting
mechanism gently to the left.
I Be careful not to bend or damage the reagent
probes during cleaning.
Do not move the pipetter arm up or down.
operation.
4
4 Clean the inside of the rinse station for the reagent

probes:
• Wipe the inside of the rinse station with a cotton
swab moistened with deionized water.
5
Roche Diagnostics
6
6 Inject 50 mL of 2% ECO-D solution into the drain of the
rinse station for the reagent probes.
7 Inject 50 mL of deionized water into the drain of the

rinse station for the reagent probes.

original position.
action reset.
9
9 To facilitate maintenance, move the microbead mixer
mechanism to the right by pushing the metal plate.
10 Repeat steps 4 to 7 for the rinse station of the

10
microbead mixer.
11 Move the microbead mixer mechanism to the left in its

original position.
12
Roche Diagnostics
13
13 To improve accessibility, do the following:
• Lower the sipper turntables to the lowest position.
• To move the rinse stations to the front, rotate the
sipper turntables 270° clockwise.
A B
A Channel 1: Sipper B Channel 2: sipper
turntable turntable
14
14 Repeat steps 4 to 7 for both rinse stations of the sipper
station.
I To facilitate cleaning, bend a cotton swab into the
shape of an L.
Clean up spills immediately.

15

u Related topics
Roche Diagnostics
1080 Maintenance as required on the e 801 module

module
You must perform the following maintenance actions as
required.
In this section
Cleaning the ECL and pre-wash flow paths of the e 801
module (1080)
Cleaning CleanCell aspiration pipes and bottle stand of the
e 801 module (1087)
Cleaning PreClean aspiration pipes and bottle stands of
Checking and cleaning the magazine drawer of the e 801
module (1095)
Cleaning the surface of the e 801 module (1098)
Checking and cleaning the cooling unit filter of the e 801
module (1100)
Cleaning the ECL and pre-wash flow paths of the e 801

module
If the number of measurements performed for each flow

path exceeds the values listed below, the instrument issues
an alarm. Then you must clean the ECL flow paths and the
pre-wash flow path.

u Infectious waste
u Moving parts
! WARNING
maintenance
representative.
Videos • Preparing the ECL flow path cleaning

• Removing reagents and consumables
Roche Diagnostics
Maintenance as required on the e 801 module 1081
c The instrument issues an alarm:

• After 10 000 measurements for each ECL flow path.
• After 20 000 measurements for the pre-wash flow
path, whichever comes first.

d m Paper towels
m 3 SysClean adapters:
Two adapters for the ECL flow paths and one adapter
for the pre-wash flow path
m LFC tool
m ISE Cleaning Solution/Elecsys SysClean solution

r To prepare flow path cleaning

1
1 Fill the SysClean adapters with SysClean solution:
• Fill the 2 adapters for the ECL flow paths with 5 mL.
• Fill the adapter for the pre-wash flow path with
3 mL.
Roche Diagnostics
2
3
• To move the SysClean adapters to the front, rotate
the sipper turntables 90° clockwise.
A B
A Channel 1: SysClean B Channel 2: SysClean

adapter adapter
4
4 Insert the filled SysClean adapters for the ECL flow
paths into their holders.
5 To move the SysClean adapters back in their original

position, rotate the sipper turntables 90°
counterclockwise.
Roche Diagnostics
6
7
8

action reset.
9
9 Insert the SysClean adapter for the pre-wash flow path
into the LFC tool:
• Move the rubber lid of the LFC tool aside.
• Insert the SysClean adapter into the LFC tool.
• Close the SysClean adapter with the rubber lid.
Roche Diagnostics
10
10 Insert the LFC tool with the filled SysClean adapter for
the pre-wash flow path into its position.
I If you spill SysClean solution, clean it up
immediately with a lint-free cloth moistened with
deionized water.

original position.
action reset.

14 If the instrument is powered off, start the instrument.
r To perform flow path cleaning


mode.
2
3
3 Choose the (26) Liquid Flow Cleaning option.
5
Roche Diagnostics
6
6 Choose the Ch 1,2 option.

f The instrument returns to Standby mode after
r To remove reagents and consumables
1
2

action reset.
3
Roche Diagnostics
4
• To move the SysClean adapters to the front, rotate
the sipper turntables 90° clockwise.
5
5 Remove all SysClean adapters from the module.
I Remove the SysClean adapter for the pre-wash flow
path together with the LFC tool.
6 To move the sipper turntables back in their original

position, rotate the sipper turntables 90°
counterclockwise.
7 Dispose of any remaining SysClean solution according

to local regulations.

original position.

action reset.

10
Roche Diagnostics
12
12 Rinse the SysClean adapters thoroughly with deionized
water.
u Related topics
Cleaning CleanCell aspiration pipes and bottle stand of

the e 801 module
If you detect crystals on the CleanCell aspiration pipes or
the bottle stand, you must clean the aspiration pipes or the
bottle stand.
You do not have to clean the ProCell aspiration pipes

during this maintenance action since the ProCell aspiration
pipes are cleaned every 2 weeks.

Take extra care: CleanCell causes severe burns!
u Infectious waste
u Moving parts

d m Lint-free cloth
m Caps of ProCell II M and CleanCell M bottles
m Paper towels
m Deionized water

Roche Diagnostics
r To clean CleanCell aspiration pipes

and bottle stand
1
A
A CleanCell M bottles
2
2 Pull up the aspiration pipes and to the left to hook them
on their respective notches.
I ProCell II M and CleanCell M solution may trickle
down. Wipe up the liquid with paper towels or a lint-
free cloth.
A B
A Notch
3
3 Close the ProCell II M and CleanCell M bottles with
bottle caps.

4 Remove the bottles from the module.
Roche Diagnostics
5
5 Clean the CleanCell aspiration pipes:
• Let the aspiration pipes dry for 1 minute.
6
6 Remove the bottle stand from the module.

A Bottle stand for ProCell II M and CleanCell M bottles
7
7 Clean the bottle stand:
• Wipe the bottle stand with a lint-free cloth
• Dry the bottle stand with a dry lint-free cloth.
Roche Diagnostics
8
8 If necessary, clean the metal sheets at the bottom of
the instrument:
• Wipe the metal sheets with a lint-free cloth
• Dry the metal sheets with a dry lint-free cloth.
9
bottles.
9 Place the bottle stand into the module.
10
10 Place the ProCell II M and CleanCell M bottles on their
original positions on the bottle stand.
11
12
into the bottles.

Roche Diagnostics

14
the Reagent option.

u Related topics
modules (607)
• Cleaning ProCell aspiration pipes of the e 801
module (1058)

Cleaning PreClean aspiration pipes and bottle stands of
the e 801 module
If you detect crystals on the bottle stands for the
PreClean II M bottles, you must clean the bottle stands.

u Infectious waste
u Moving parts

d m Lint-free cloth
m Caps of PreClean II M bottles
m Paper towels
m Deionized water
Roche Diagnostics

r To clean PreClean aspiration pipes

and bottle stand
1
2
2 Pull the aspiration pipes up and back to hook them on
their respective notches.
I PreClean II M solution may trickle down when you
remove the bottles. Wipe up the liquid with paper
towels or a lint-free cloth.
3
3 Absorb liquid from the filter with a lint-free cloth.
4 Before removing the PreClean II M bottles, mark the

bottle position (left/right) on each bottle.
Roche Diagnostics
5
5 Remove the PreClean II M bottles gently from the
module to avoid the formation of foam.
6
6 Close the PreClean II M bottles with bottle caps.
7

• Dry the aspiration pipes with a dry lint-free cloth.
8
8 Clean the bottle stands:
• Wipe the bottle stands with a lint-free cloth
• Dry the bottle stands with a dry lint-free cloth.
Roche Diagnostics
10
bottles.
10 Place the bottles gently into the bottle stands.
11
at a PreClean II M aspiration pipe is loose or lost.
aspiration pipe.
into the bottles.


14
the Pre-wash option.

u Related topics
modules (607)
Roche Diagnostics
Checking and cleaning the magazine drawer of the e 801

module
You must check the magazine drawer for spills and dirt. If
the magazine drawer is dirty, you must clean it.

u Infectious waste
Video Checking and cleaning the magazine drawer
d m Lint-free cloth
m Deionized water
m Two solid waste boxes (Wasteliner)


r To clean the magazine drawer
1
1 Make sure that the status indicator is on.
2 Pull out the magazine drawer.

2
A B
A Status indicator B Handle of the
magazine drawer
Roche Diagnostics
3
3 Remove both solid waste boxes from the solid waste
containers and dispose of them according to local
regulations.
4 Remove the empty magazines from the magazine waste

compartment and dispose of them according to local
regulations.
A B C D
A Solid waste box C Empty magazines
B Solid waste container D Magazine waste
compartment
5
5 Wipe the inside and outside of the solid waste
containers and of the magazine waste compartment
with a lint-free cloth moistened with disinfectant.

with a lint-free cloth moistened with deionized water.
7 Dry the solid waste containers and the magazine waste

compartment with a dry lint-free cloth.
8
8 If the area surrounding the solid waste containers is
dirty, repeat steps 5 to 7 for this area.
Roche Diagnostics
9
9 Place new solid waste boxes into the solid waste
containers.
10 Close the magazine drawer.
11
11 Open the front door of the magazine drawer.
12
12 To update the inventory, press the buttons

corresponding to the emptied solid waste containers.
f The buttons flash for a moment and then turn on.
The inventory update is displayed in the Reagent
Overview dialog box.
13 Close the front door of the magazine drawer.

I If the door is not fully closed, the module cannot
operate.
u Related topics
A B • About reagent statuses (307)
A Button for left solid B Button for right solid • Unmasking a module (777)
waste container waste container
Roche Diagnostics
Cleaning the surface of the e 801 module


cleaning.


u Infectious waste
u Moving parts

m Deionized water
m Cotton swabs

1
Roche Diagnostics
2
3
3 Clean the reagent loading ports with lint-free cloth or
paper towels moistened with deionized water or
disinfectant.
4
4 Clean the cap pre-opener area with cotton swabs

5
5 Clean the areas around the reagent pipetting positions
with lint-free cloth or paper towels moistened with
deionized water or disinfectant.

Roche Diagnostics
u Related topics
Checking and cleaning the cooling unit filter of the e 801

module
To prevent the accumulation of dust and dirt, you must
check the cooling unit filter and clean it if it is dirty.
d m Paper towels
m Water for rinsing
m Vacuum cleaner

r To check/clean the cooling unit filter
1
Roche Diagnostics
2
2 Detach the cooling unit filter by pulling it upward.
3
3 Vacuum the cooling unit filter.
4
4 If the cooling unit filter is visibly contaminated, rinse the

cooling unit filter with water and dry it with paper
towels.
5
5 Reinstall the cooling unit filter.

u Related topics
Roche Diagnostics
1102
17 Maintenance of the e 801 module Maintenance as required on the e 801 module
Roche Diagnostics
1103
Table of contents
Maintenance of the e 602 module 18
In this chapter 18
List of maintenance actions on the e 602 module . . . 1105
Daily maintenance of the e 602 module . . . . . . . . . . . . 1106
Cleaning probes and nozzles of the e 602 module 1106
Weekly maintenance of the e 602 module . . . . . . . . . . 1110
replacing PC/CC cups of the e 602 module. . . . . . 1110
Cleaning the vortex mixers and separation
stations of the e 602 module . . . . . . . . . . . . . . . . . . 1114
Cleaning the incubator disk of the e 602 module . 1117
Cleaning the microbead mixer of the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1120
Cleaning the rinse stations of the e 602 module . 1123
Every 2 weeks maintenance of the e 602 module. . . . 1127
Cleaning the ECL flow path of the e 602 module . 1127
Quarterly maintenance of the e 602 module. . . . . . . . 1131
Replacing the pinch valve tubing of the e 602

module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1131
Maintenance as required on the e 602 module . . . . . . 1137
Cleaning ProCell/CleanCell aspiration pipes and
bottle stand of the e 602 module . . . . . . . . . . . . . . 1137
Cleaning the reagent disk and reagent storage . . 1141
Cleaning the magazine drawer of the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1146
Cleaning the surface of the e 602 module . . . . . . 1149
Roche Diagnostics
1104
Table of contents
Roche Diagnostics
List of maintenance actions on the e 602 module 1105

module
Periodic maintenance ensures that the module works
properly and minimizes the risk of contamination. You must
observe the maintenance intervals in the following table.
The maintenance intervals are independent of the

PO Powered off
SB Standby mode

Daily maintenance Cleaning probes and nozzles of the e 602 module (1106) MC/PO
Weekly maintenance Cleaning ProCell/CleanCell supply nozzles and replacing SB/MM
Cleaning the vortex mixers and separation stations of the MC/PO
e 602 module (1114)

Cleaning the incubator disk of the e 602 module (1117) SB/MM/PO
Cleaning the microbead mixer of the e 602 module (1120) MC/PO
Cleaning the rinse stations of the e 602 module (1123) MC/PO
Every two weeks Cleaning the ECL flow path of the e 602 module (1127) SB
maintenance
Quarterly maintenance Replacing the pinch valve tubing of the e 602 module (1131)(1) SB/MM
(PO required during this
maintenance action)
Maintenance as required Cleaning ProCell/CleanCell aspiration pipes and bottle stand SB/MM/PO
of the e 602 module (1137)
Cleaning the reagent disk and reagent storage (1141) SB/MM
Cleaning the magazine drawer of the e 602 module (1146) SB/MM/PO
Cleaning the surface of the e 602 module (1149) SB/MM/PO
y List of maintenance actions of e 602 module
(1) Every 3 months, or after measuring 25 000 tests per measuring cell, whichever comes first.
u Related topics
Roche Diagnostics
Daily maintenance of the e 602 module

day.
After maintenance, if the instrument is going to be

powered off or remain in Standby mode for an extended
time, you must perform manual finalization. If you process
further samples, finalization is not necessary.
u Performing manual finalization on cobas e
modules (607)
In this section
Cleaning probes and nozzles of the e 602 module (1106)
Cleaning probes and nozzles of the e 602 module

To ensure that the instrument measures accurately, you
must clean the sample probe, reagent probe, the nozzles
of the pre-wash area, and the ECL sipper nozzles.

u Infectious waste
u Moving parts
u Fire and burns
d m Alcohol
m Deionized water
m Lint-free cloth
m Paper towels
j m The module is in manual cleaning (Maintenance mode).

mode) (783)
Roche Diagnostics
r To clean probes and nozzles
1
2
2 WARNING! Incorrect results may occur due to improper
cleaning or due to a deformed probe.
Use a new lint-free cloth for each probe to prevent
carryover.
Do not bend or damage the probes during cleaning.
Move the pipetter arm gently. Do not move it up or
down.
Ensure that no cleaning material falls into AssayTips or
AssayCups. Keep the magazine cover closed during

cleaning.
2 Wipe the outside of the sample probe from top to
bottom with a lint-free cloth moistened with deionized
water.
3 If the sample probe still appears dirty, do the following:

• Wipe the outside from top to bottom with a lint-free
• Immediately afterwards, wipe the outside from top
to bottom with a cloth moistened with deionized
water.
damaged.
Roche Diagnostics
4
disk, place a paper towel over the reagent pipetting
positions.
5
5 Clean the outside of the reagent probe:
• Wipe the probe from top to bottom with a lint-free
• Wipe the probe from top to bottom with a lint-free
6
6 Clean the outside of the nozzles of the pre-wash area:

7
7 Clean the outside of the ECL sipper nozzles:
8 Remove the paper towel from the module.
9 Close the top cover and lock it with the key.
Roche Diagnostics
r To check the sample probe and

reagent probe

mode.
2
3
3 Choose the (36) System Air Purge (e602/e801) option.
5
6

9 During system air purge, visually check that the sample

and reagent probe discharge water in a straight flow.
u Related topics
Roche Diagnostics
1110 Weekly maintenance of the e 602 module
Weekly maintenance of the e 602 module

least once every week.
In this section
e 602 module (1114)
Cleaning the incubator disk of the e 602 module (1117)
Cleaning the microbead mixer of the e 602 module (1120)
Cleaning the rinse stations of the e 602 module (1123)

To prevent the accumulation of crystals, you must clean
the ProCell/CleanCell supply nozzles and replace the
PC/CC cups.


u Infectious waste
u Moving parts
Videos • Cleaning ProCell/CleanCell supply nozzles and liquid

level sensors
• Replacing PC/CC cups

d m Cotton swabs
m Deionized water
m Two PC/CC cups

Roche Diagnostics
r To empty PC/CC cups
1
2
4

r To clean ProCell/CleanCell supply

nozzles and liquid level sensors

1
Roche Diagnostics
2
2 To facilitate maintenance, manually move the ECL
sipper nozzles over the incubator disk.
I Do not bend or damage the lower end of the ECL
sipper nozzles and liquid level sensors. If they are
bent, contact your Roche Service representative.
3
3 Carefully pull up the ProCell/CleanCell filling unit to the
stop/hold position using the black handle.
4
4 Wipe each ProCell/CleanCell supply nozzle with a
cotton swab moistened with deionized water.
5 Wipe each liquid level sensor with a cotton swab

A B A
A ProCell/CleanCell B Liquid level sensors
nozzles
Roche Diagnostics
r To replace PC/CC cups
1
1 Carefully remove the PC/CC cups by pulling them
upwards and to the left.
I Make sure that the liquid level sensors are not bent.
2 Dispose of the PC/CC cups according to local

regulations.
3
3 Wipe the PC/CC cup positions with a cotton swab

4
4 Place new PC/CC cups into the PC/CC cup positions.
Roche Diagnostics
5
5 Carefully push the PC/CC filling unit back into place.
7
the Reagent option.
u Related topics

e 602 module
Spills on the vortex mixers or separation stations can cause
a gripper movement alarm. You must clean the vortex
mixers and separation stations regularly.

u Infectious waste
u Moving parts
Roche Diagnostics
NOTICE
the aluminum.
Video Cleaning the vortex mixers and separation stations
d m Cotton swabs
m Lint-free cloth
m Deionized water
m Paper towels

mode) (783)

r To clean the vortex mixers and
separation stations
1
Roche Diagnostics
2
2 Clean the surfaces of all vortex mixers and separation
stations with a lint-free cloth moistened with deionized
water.
I Do not bend or damage the nozzles of the pre-wash
area.
3 If the surfaces of the vortex mixers and separation

stations are still dirty, scrub them gently with the
moistened lint-free cloth.
4
4 Clean the openings of the vortex mixers and separation
stations with cotton swabs moistened with deionized

water.
Roche Diagnostics
5
5 Dry the vortex mixers and separation stations with a dry
lint-free cloth and cotton swabs.
I Make sure that the surfaces and the openings of the
vortex mixers and separation stations are dry and
not clogged by reagent or sample spills. Otherwise,
an instrument alarm concerning the grippers may be
issued when operation is resumed.
u Related topics

Cleaning the incubator disk of the e 602 module
To prevent gripper movement alarms, you must clean the
incubator disk.

u Infectious waste
NOTICE
the aluminum.
Video Cleaning the incubator disk
Roche Diagnostics
d m Lint-free cloth
m Cotton swabs
m Deionized water

r To clean the incubator disk
1
2
2 If necessary, turn the pre-wash gripper towards the
pre-wash area, to allow the incubator cover to be
removed.
A
A Pre-wash gripper
Roche Diagnostics
3
3 Remove the cover of the incubator.
4
4 To clean the incubator cover, do the following:
• Clean the incubator cover with a lint-free cloth
• If the incubator cover is still dirty, scrub it gently
5
5 To clean the top of the incubator, do the following:

• Clean the top of the incubator with a lint-free cloth
• If the top of the incubator is still dirty, scrub it gently
6
6 Clean each of the 54 positions on the incubator disk
with cotton swabs moistened with deionized water.
Roche Diagnostics
7
7 Dry the incubator disk and its positions with a dry lint-
free cloth and cotton swabs.
I Make sure that the incubator disk and its positions
are dry and not clogged by reagent or sample spills.
Otherwise, an instrument alarm concerning the
grippers may be issued when operation is resumed.
8 Replace the incubator cover.
11
11 If you have moved the pre-wash gripper manually,
perform the maintenance action reset:
• Choose the (1) Reset option.
• Select the affected module.
u Related topics
Cleaning the microbead mixer of the e 602 module

To ensure that the module measures accurately, you must
clean the microbead mixer.

u Infectious waste
u Moving parts
u Fire and burns
Video Cleaning the microbead mixer
Roche Diagnostics
d m Lint-free cloth
m Alcohol
m Deionized water
m Small brush
m Paper towels

mode) (783)
r To clean the microbead mixer
1

A
2
disk, place paper towels over the reagent pipetting
positions and the microbead mixing position.
Roche Diagnostics
3
3 Carefully wipe the microbead mixer paddle from top to
bottom with a lint-free cloth moistened with alcohol.
I Ensure that the microbead mixer paddle is not
damaged.
damaged.
4
4 Clean the 4 propeller blades with a brush moistened
with alcohol.
5 Repeat steps 3 to 4 with deionized water instead of

alcohol.

6 Remove the paper towels from the reagent pipetting
positions and the microbead mixing position.

r To check the microbead mixer

mode.
2
3
3 Choose the (14) Bead Mixer Check option.
Roche Diagnostics
5
u Related topics
Cleaning the rinse stations of the e 602 module

To prevent contamination, you must clean the rinse
stations of the reagent probe, the microbead mixer, the
nozzles of the pre-wash area, and the ECL sipper nozzles.
A B C D
A Microbead mixer rinse station C Reagent probe rinse station

B Rinse station of the nozzles of the pre-wash area D ECL sipper nozzles rinse station

u Infectious waste
u Moving parts
u Fire and burns
Roche Diagnostics
Video Cleaning the rinse stations
d m Paper towels
m Cotton swabs
m Alcohol
m 2% ECO-D solution
m Deionized water
m 50 mL syringe with tubing or wash bottle

mode) (783)
1
Roche Diagnostics
2
disk or the ProbeWash bottles, place paper towels over
the reagent pipetting positions and the ProbeWash
bottles.
3
3 Clean the inside of the reagent probe rinse station:
swab moistened with deionized water.
4
5
5 Inject 50 mL of 2% ECO-D solution into the drain of the
reagent probe rinse station.
6 Inject 50 mL of deionized water into the drain of the

reagent probe rinse station.
7 Repeat steps 3 to 6 for the rinse stations of the

microbead mixer, the nozzles of the pre-wash area, and
the ECL sipper nozzles.
8 Remove the paper towels from the reagent pipetting

positions and the ProbeWash bottles.
Roche Diagnostics
u Related topics
Roche Diagnostics

module
least every 2 weeks.
In this section
Cleaning the ECL flow path of the e 602 module (1127)
Cleaning the ECL flow path of the e 602 module

To ensure the instrument measures accurately, you must
clean the ECL flow path.

u Infectious waste
u Moving parts
Video Preparing the ECL flow path cleaning

c • Every 2 weeks, or
• After 2500–3000 measurements per measuring
channel, whichever comes first.

that you note down the test counts when performing this
maintenance.

d m Two SysClean adapters

m ISE Cleaning Solution/Elecsys SysClean solution
Roche Diagnostics
r To prepare the ECL flow path

cleaning
1
1 Take out both SysClean adapters.
2
2 Fill the 2 SysClean adapters each with 9 mL of
SysClean solution (up to the lower line).
3
3 Insert the filled SysClean adapters into their positions.
I If you spill SysClean solution, clean it up
immediately with a lint-free cloth moistened with
deionized water.
r To perform liquid flow cleaning
1
Roche Diagnostics
2
2 Choose the (26) Liquid Flow Cleaning option.
4
5

f The instrument returns to Standby mode after
r To remove reagents and consumables

1
1 Remove both SysClean adapters from the module.
2 Dispose of any remaining SysClean solution according

Roche Diagnostics
4
4 Rinse the SysClean adapters thoroughly with deionized
water.
Roche Diagnostics
Quarterly maintenance of the e 602 module 1131
Quarterly maintenance of the e 602 module

least every 3 months.
In this section
Replacing the pinch valve tubing of the e 602
module (1131)
Replacing the pinch valve tubing of the e 602 module

To ensure proper functionality of the pinch valves, you
must replace the pinch valve tubing.

u Infectious waste
u Moving parts
Video Replacing the pinch valve tubing
c • Every 3 months, or

• After 25 000 measurements per measuring channel,
whichever comes first.

that you note down the test counts when performing this
maintenance.

d m Four pieces of pinch valve tubing

m Lint-free cloth

Roche Diagnostics
1132 Quarterly maintenance of the e 602 module
r To perform MC exchange
1
2
2 Choose the (25) MC Exchange option.
4
5


Roche Diagnostics
r To replace the pinch valve tubing
2
A
A Pinch valves and tubing
3
3 WARNING! Liquid from the pinch valve tubing and the
C D
acrylic block comes from the measuring cells and is
potentially biohazardous.
Wear gloves when removing the tubings. Wipe up all
spills immediately.
3 Carefully remove all 4 pieces of pinch valve tubing by
pulling them from the tube fittings.

4 Dispose of the pieces of pinch valve tubing according
A B
A Acrylic block C Pinch valve

B Tube fitting D Pinch valve tubing
5
5 Absorb liquid from the acrylic block or from the tubing
with a dry lint-free cloth.
Roche Diagnostics
6
6 Insert new pieces of pinch valve tubing through the
pinch valves.
7
7 Slide the ends of the pinch valve tubing over each tube
fitting.
r To perform a sipper air purge
1 Start the instrument.

f After approx. 9–12 minutes, the Standby mode is
displayed.
2
3
3 Choose the (23) Sipper Air Purge option.
Roche Diagnostics
5
6
I If only one piece of pinch valve tubing has been
replaced, choose the corresponding measuring
channel.
9
9 While the maintenance action is executed, inspect the
syringes:
• If air bubbles remain in a syringe, remove them by
A lightly tapping the syringe while the liquid is flowing.
If you cannot remove the air bubbles, contact your
B Roche Service representative.
A • If a leak is visible on one of the syringe connectors,
try to tighten the connection.
• If a leak is visible at the bottom of one of the
syringes, contact your Roche Service
representative.

C
A Syringe connectors C Bottom of the syringe
B Syringe
10
10 While the maintenance action is executed, make sure
that enough water is discharged from the ECL sipper
nozzles.
I The amount of water is sufficient when air bubbles
are no longer visible.
Roche Diagnostics
r To perform MC preparation
1
2
2 Choose the (24) MC Preparation option.
4
5
I If only one piece of pinch valve tubing has been
replaced, choose the corresponding measuring
channel.
8
8 While the maintenance action is executed, inspect the
syringes:
• If a leak is visible on one of the syringe connectors,
A try to tighten the connection.
• If a leak is visible at the bottom of one of the
B
syringes, contact your Roche Service
A representative.

u Related topics
C
A Syringe connectors C Bottom of the syringe
B Syringe
Roche Diagnostics

module
You must perform the following maintenance actions as
required.
In this section
Cleaning ProCell/CleanCell aspiration pipes and bottle
stand of the e 602 module (1137)
Cleaning the reagent disk and reagent storage (1141)
Cleaning the magazine drawer of the e 602 module (1146)
Cleaning the surface of the e 602 module (1149)
Cleaning ProCell/CleanCell aspiration pipes and bottle

stand of the e 602 module
If you detect crystals on the bottle stand for the
ProCell M/CleanCell M bottles, you must clean the bottle
stand.

Take extra care: CleanCell causes severe burns!
u Infectious waste
u Moving parts

d m Lint-free cloth
m Caps of ProCell M and CleanCell M bottles
m Paper towels
m Deionized water

Roche Diagnostics
r To clean ProCell/CleanCell aspiration

pipes and bottle stand
1
2
2 Pull up the aspiration pipes and to the left to hook them
on their respective notches.
I ProCell M and CleanCell M solution may trickle
down. Wipe up the liquid with paper towels or a lint-
free cloth.
A B C
A Aspiration pipe C Notch
B Aspiration filter
3
3 Close the ProCell M and CleanCell M bottles with bottle
caps.

4
4 Remove the bottles from the module.
Roche Diagnostics
5
• Dry the aspiration pipes with a dry lint-free cloth.
6
6 Remove the bottle stand from the module.

A Bottle stand for ProCell M and CleanCell M bottles
7
7 Clean the bottle stand:
• Wipe the bottle stand with a lint-free cloth
• Dry the bottle stand with a dry lint-free cloth.
Roche Diagnostics
8
8 If necessary, clean the metal sheets at the bottom of
the instrument:
• Wipe the metal sheets with a lint-free cloth
• Dry the metal sheets with a dry lint-free cloth.
9
9 CAUTION! Incorrect results may occur due to misplaced
ProCell M/CleanCell M bottles.
9 Place the bottle stand into the module.
10
10 Place the ProCell M and CleanCell M bottles on their
original positions on the bottle stand.
11
12
aspiration pipe.
into the bottles.

Roche Diagnostics

14
the Reagent option.

u Related topics
modules (607)
Cleaning the reagent disk and reagent storage

If the reagent disk or the reagent storage are dirty, you
must clean them. You must clean up reagent spills
immediately.

u Infectious waste
u Moving parts
u Fire and burns
Videos • Removing the reagent disk

• Cleaning the reagent disk and reagent storage
• Reinstalling the reagent disk
d m Lint-free cloth
m Alcohol
m Deionized water
Roche Diagnostics

r To remove the reagent disk
1
1 Unlock and lift the reagent disk cover.
I Do not bend the microbead mixer. If the microbead
mixer is bent, contact your Roche Service
representative.
2
2 Fully close all reagent cassettes on the reagent disk
positions.
A B C

B Open
3
3 Remove all reagent cassettes from the reagent disk
and store them in a refrigerator.
I For information about the onboard stability of
reagents, refer to the Instructions for Use.
Roche Diagnostics
4
4 Loosen and remove the black thumbscrews.
5
5 Remove the empty reagent disk from the reagent
storage.

r To clean the reagent storage
1
1 Wipe the reagent storage with a lint-free cloth
I Do not scratch or smear the barcode reader window
as this may cause barcode read errors.
2 If the reagent storage still appears dirty, do the

following:
• Wipe the reagent storage with a lint-free cloth
• Afterwards, wipe the reagent storage with a lint-
free cloth moistened with deionized water.
A damaged.
A Barcode reader window
3 Dry the reagent storage with a dry lint-free cloth.
Roche Diagnostics
r To clean and reinstall the reagent

disk
1
1 Wipe the inside and outside of the reagent disk with a
lint-free cloth moistened with deionized water.
2 If the reagent disk still appears dirty, do the following:

• Wipe the inside and outside of the reagent disk with
• Afterwards, wipe the inside and outside of the
reagent disk with a lint-free cloth moistened with
deionized water.
damaged.
3 Dry the reagent disk with a dry lint-free cloth.
4
4 Insert the reagent disk into the reagent storage.
I Make sure that the alignment pin on the center plate
is aligned with the opening on the disk.
A Alignment pin
Roche Diagnostics
5
5 Insert and tighten the black thumbscrews.
6 Return the reagent cassettes to the reagent disk:

6
• Open the caps of the reagent cassettes and put
them to soft-close position. Make sure that the caps
are almost closed, but not tightly closed.
• Ensure the correct orientation of the reagent
cassettes with the white or clear bottles facing
outwards and the black bottles facing inwards.
• Place reagent cassettes with only one or 2 reagent
bottles at the inside of the reagent disk.
I The reagent disk has pins that snap into semicircular
openings in the reagent cassettes if the reagent
cassettes are correctly oriented.
If the pins do not snap in, the reagent cassettes are
not correctly oriented.

7
7 Return and lock the reagent disk cover.
f The reagent cassettes are opened and the reagents
are registered automatically.
u Related topics
Roche Diagnostics
Cleaning the magazine drawer of the e 602 module

If the magazine waste compartment or the solid waste
containers are dirty, you must clean them.

u Infectious waste
Videos • Removing solid waste boxes and empty magazines

• Cleaning the solid waste containers and the magazine
waste compartment
• Placing new solid waste boxes into the solid waste
containers
d m Lint-free cloth
m Deionized water
m Two solid waste boxes (Wasteliner)
j

r To clean the magazine drawer
1
1 Make sure that the status indicator is on.
2 Pull out the magazine drawer.
A B
A Status indicator B Handle of the
magazine drawer
Roche Diagnostics
3
3 Remove both solid waste boxes from the solid waste
containers and dispose of them according to local
regulations.
4 Remove the empty magazines from the magazine waste

compartment and dispose of them according to local
regulations.
A B C D
A Solid waste box C Magazine waste
compartment
B Solid waste container D Empty magazines
5
with a lint-free cloth moistened with disinfectant.

with a lint-free cloth moistened with deionized water.
7 Dry the solid waste containers and the magazine waste

compartment with a dry lint-free cloth.

8
8 If the area surrounding the solid waste containers is
dirty, repeat steps 5 to 7 for this area.
Roche Diagnostics
9
9 Place new solid waste boxes into the solid waste
containers.
10
10 Close the magazine drawer.
11
11 Open the front door of the magazine drawer.
Roche Diagnostics
12
12 To update the inventory, press the buttons
corresponding to the emptied solid waste containers.
f The buttons flash for a moment and then turn on.
The inventory update is displayed in the Reagent
Overview dialog box.
13 Close the front door of the magazine drawer.

I If the door is not fully closed, the module cannot
operate.
u Related topics
A B • About reagent statuses (307)
A Button for left solid B Button for right solid • Unmasking a module (777)
waste container waste container
Cleaning the surface of the e 602 module



cleaning.


u Infectious waste
u Moving parts

m Deionized water

Roche Diagnostics
1
2

u Related topics
Roche Diagnostics
Troubleshooting
19 Data alarms....................................................................................... 1153

20 Troubleshooting................................................................................ 1231
Roche Diagnostics
1153
Table of contents
Data alarms 19
In this chapter 19
About data alarms and instrument alarms . . . . . . . . . . 1157
List of data alarms for tests . . . . . . . . . . . . . . . . . . . . . . 1159
Data alarms of ISE module tests . . . . . . . . . . . . . . . . . . 1161
ADC.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1161
Calc.?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1161
Cal.E (for samples). . . . . . . . . . . . . . . . . . . . . . . . . . . 1162
Cal.I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1162
ClcT.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1163
CmpT.? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1163
CmpT.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1164
Edited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1164
< >ISE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1165
>I.H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1165
>I.HI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1165
>I.I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1166
>I.L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1166
>I.LH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1166
>I.LHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1166
>I.LI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1167
19 Data alarms
ISE.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1167
ISE.N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1168
na.LHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1169
Over.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1169
Reag.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1170
>Rept/<Rept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1170
Samp.C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1171
Samp.O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1171
Samp.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1171
< >Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1172
>Test/<Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1173
Roche Diagnostics
1154
Table of contents
Data alarms of photometric tests . . . . . . . . . . . . . . . . . 1174

>Abs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1174
ADC.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1175
Calc.?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1176
Cal.E (for samples). . . . . . . . . . . . . . . . . . . . . . . . . . . 1176
Cal.I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1176
ClcT.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1177
CmpT.? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1177
CmpT.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1178
>Cuvet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1178
Det.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1180
Edited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1180
>I.H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1180
>I.HI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1180
>I.I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1181
>I.L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1181
>I.LH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1181
>I.LHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1182
>I.LI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1182
>Kin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1182
>Lin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1182
MIXLOW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1183
MIXSTP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1184
na.LHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1184
OBS.RM (c 702 module only) . . . . . . . . . . . . . . . . . . 1184
OBS.RR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1185
Over.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1185
>Proz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1185
>React . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1186
ReagEx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1186
Reag.S (c 701/c 702 modules only) . . . . . . . . . . . . 1187
>Rept/<Rept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1187
Samp.?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1188
Samp.C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1188
Samp.O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1188
Samp.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1189
>Test/<Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1189
Data alarms of immunology tests . . . . . . . . . . . . . . . . . 1190
ADC.E (e 602 module only). . . . . . . . . . . . . . . . . . . . 1190
Calc.?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1191
19 Data alarms
Cal.E (for samples). . . . . . . . . . . . . . . . . . . . . . . . . . . 1191

Cal.I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1191
CarOvr . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1192
Cell.T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1192
Clot.E (e 602 module only) . . . . . . . . . . . . . . . . . . . . 1193
>Curr . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1193
Edited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1193
>I.H (e 602 module only) . . . . . . . . . . . . . . . . . . . . . . 1194
>I.HI (e 602 module only) . . . . . . . . . . . . . . . . . . . . . 1194
>I.I (e 602 module only) . . . . . . . . . . . . . . . . . . . . . . . 1194
>I.L (e 602 module only) . . . . . . . . . . . . . . . . . . . . . . 1195
>I.LH (e 602 module only) . . . . . . . . . . . . . . . . . . . . . 1195
Roche Diagnostics
1155
Table of contents
>I.LHI (e 602 module only) . . . . . . . . . . . . . . . . . . . . 1195

>I.LI (e 602 module only). . . . . . . . . . . . . . . . . . . . . . 1195
Inc.T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1196
na.LHI (e 602 module only) . . . . . . . . . . . . . . . . . . . 1196
OBS.RR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1197
Over.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1197
ReagEx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1197
Reag.F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1198
Reag.H. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1198
Reag.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1198
Reag.T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1199
>Rept/<Rept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1199
Samp.B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1200
Samp.C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1201
Samp.O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1201
Samp.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1201
<SigL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1202
SLLD.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1202
SLLD.N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1203
SysR.S (e 602 module only) . . . . . . . . . . . . . . . . . . . 1203
SysR.T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1203
>Test/<Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1204
WB.S (e 602 module only) . . . . . . . . . . . . . . . . . . . . 1204
WBSS.T (e 801 module only) . . . . . . . . . . . . . . . . . . 1205
WB.T. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1205
Alarms for calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . 1206
Cal.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1207
Cond.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1208
Diff.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1209
Duplicate error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1209
Dup.E (cobas c modules) . . . . . . . . . . . . . . . . . . 1209
Dup.E (cobas e modules) . . . . . . . . . . . . . . . . . . 1210
IStd.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1211
MAX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1212
MIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1212
Mono.E (e 602 module only). . . . . . . . . . . . . . . . . . . 1212
Prep.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1213
Rsp1.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1213
Rsp2.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1214
S1A.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1214
19 Data alarms
SD.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1215
Sens.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1215
>Sig . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1216
<Sig . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1216
Sig.E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1217
Slop.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1217
Std.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1218
Std.E (ISE module) . . . . . . . . . . . . . . . . . . . . . . . . 1218
Std.E (cobas c modules) . . . . . . . . . . . . . . . . . . . 1219
Sys.E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1220
Roche Diagnostics
1156
Table of contents
Data alarm for QC materials . . . . . . . . . . . . . . . . . . . . . . 1221

QCErr. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1221
List of data alarms for QC measurements . . . . . . . 1222
Data problems without alarm . . . . . . . . . . . . . . . . . . . . . 1224
Drift of result data . . . . . . . . . . . . . . . . . . . . . . . . . . . 1224
Erroneous operation . . . . . . . . . . . . . . . . . . . . . . . . . 1224
Poor reproducibility . . . . . . . . . . . . . . . . . . . . . . . . . . 1225
High test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1225
Low test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1226
Problems due to the properties of a reagent. . . . . 1226
Problems with every test. . . . . . . . . . . . . . . . . . . . . . 1226
Problems on all analytical modules. . . . . . . . . . . . . 1227
Problems on both measuring channels on the
same module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1227
Rerun test list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1228
19 Data alarms
Roche Diagnostics
About data alarms and instrument alarms 1157
About data alarms and instrument alarms

If any abnormality occurs while the system is switched on,
the system notifies the operator of the potential problem
by issuing an alarm.
Alarm types and levels Alarms are classified into different types and levels:
• Data alarms refer to irregular measuring results or
conditions.
• Instrument alarms refer to irregular system conditions.
Type Level Meaning

Data alarms:
Data alarm This alarm is related to the results of calibrations, QC, or
samples. The instrument does not stop operation.
Instrument alarms:
Caution This alarm is generated by data alarms or problems with the
instrument. If this alarm occurs during operation, the
instrument does not stop operation. The operator must judge
whether to continue or interrupt the measurement.
S.Stop This alarm is related to problems with the instrument. For
(Sampling stop) pipetted samples, the measurement continues.
Stop This alarm is related to problems with the instrument. The
corresponding module or the entire instrument stops
operation. For the sample under measurement, no result data
is obtained and the measurement must be repeated.
E.Stop This alarm is generated by hardware failures or if any of the
(Emergency stop) safety devices requested an emergency stop. The system
requires either complete power off, or at least a reset to
resume normal operation.
y Alarm types and levels
Data alarms Data alarms are indicated on the Workplace > Data Review
submenu, on the Test Review window (Workplace > Data
Review > Test Review), and on printed reports. If a data
alarm occurs, the data alarm is attached to the test result
and indicated in the user interface and on reports.
For QC and samples, a data alarm consists of an alarm

message and a result message. The result messages are
specific to the tests.
19 Data alarms
Automatic rerun: Some data alarms trigger an automatic

rerun test. If such a data alarm occurs on a test for which
automatic rerun is selected (check box on Utility
> Application > Range), a rerun test is automatically
requested. For execution of the automatic rerun during
measurement, however, automatic rerun needs to be
activated on the Start window as well.
u Rerun test list (1228)
u List of data alarms for tests (1159)
Roche Diagnostics
1158 About data alarms and instrument alarms
Instrument alarms Instrument alarms are indicated by the Alarm button on the
Overview menu. An audible alarm can be activated
additionally.
If an alarm occurs, the Alarm button lights up. Its color

indicates the alarm level:
Color Meaning
Yellow indicates caution level.
Red indicates any alarm above caution

level (S.Stop, Stop, or E.Stop).
y Colors for instrument alarm levels
If there is an alarm, choose the Alarm button to open the

Alarm window. This window provides an alarm list and
descriptions and remedies for each listed alarm.
u Alarm window (1366)
Sound window (1369)
19 Data alarms
Roche Diagnostics
List of data alarms for tests 1159
List of data alarms for tests

The following table displays the data alarms applicable to
test results, and their long name used in the data manager.
q Calibration and QC alarms are not included in the

table below.
u Alarms for calibrations (1206)
Data alarm for QC materials (1221)
Data alarm Data alarm (long name) ISE c 701 c 702 c 502 e 801 e 602
>Abs ABS over – l l l – –
ADC.E ADC abnormal l l l l – l
Calc.? Calculation not possible l l l l l l
Cal.E (for samples) Calibration result abnormal (for samples) l l l l l l
Cal.I Calibration result invalid l l l l l l
CarOvr Potential carryover – – – – l l
Cell.T Cell temperature – – – – l l
ClcT.E Calculation test error l l l l – –
Clot.E Clot pressure abnormal – – – – – l
CmpT.? Unable to calculate comp. test (compensation test) l l l l – –
CmpT.E Data error in comp. test (compensation test) l l l l – –
>Curr Current range over – – – – l l
>Cuvet ABS Cell blank abnormal – l l l – –
Det.S Carryover detergent short – l l l – –
Edited Edited test l l l l l l
< >ISE ISE range over l – – – – –
>I.H Serum index interference hemolysis l l l l – l
>I.HI Serum index interference hemolysis/icteric l l l l – l
>I.I Serum index interference icteric l l l l – l
>I.L Serum index interference lipaemia l l l l – l
>I.LH Serum index interference lipaemia/hemolysis l l l l – l
>I.LHI Serum index interference lipaemia/hemolysis/icteric l l l l – l
>I.LI Serum index interference lipaemia/icteric l l l l – l
Inc.T Incubator temperature – – – – l l
ISE.E ISE voltage level error l – – – – –
19 Data alarms
ISE.N ISE noise error l – – – – –

>Kin Kinetic unstable (Prozone error 2) – l l l – –
>Lin Linearity abnormal – l l l – –
MIXLOW Mixing current low – l l l – –
MIXSTP Stop mixing – l l l – –
na.LHI Serum index measurement not performed l l l l – l
OBS.RM On-board stability limit over on reagent manager – – l – – –
OBS.RR On-board stability limit over on reagent rotor – l l l l l
Over.E Overflow l l l l l l
y List of data alarms for tests
Roche Diagnostics
1160 List of data alarms for tests
>Proz Prozone error – l l l – –
>React Reaction limit over – l l l – –
ReagEx Reagent expired date – l l l l l
Reag.F Reagent film or foam detection – – – – l l
Reag.H Reagent hovering – – – – l l
Reag.S Reagent short l l l – l l
Reag.T Reagent disk temperature – – – – l l
>Rept/<Rept Repeat limit over (upper)/(lower) l l l l l l
Samp.? ABS maximum over (non-lin curve) – l l l – –
Samp.B Sample air bubble – – – – l l
Samp.C Sample clot l l l l l l
Samp.O Sample carryover for modules l l l l l l
Samp.S Sample short l l l l l l
<SigL Minimum signal – – – – l l
SLLD.E Sample LLD abnormal – – – – l l
SLLD.N Sample LLD noise – – – – l l
SysR.S System reagent short – – – – – l
SysR.T System reagent temperature – – – – l l
< >Test ISE sample range over l – – – – –
>Test/<Test Technical limit over (upper)/(lower) l l l l l l
WB.S Washing buffer short – – – – – l
WBSS.T Washing buffer SS temperature – – – – l –
WB.T Washing buffer temperature – – – – l l
19 Data alarms
Roche Diagnostics
Data alarms of ISE module tests
Data alarm ISE Data alarm ISE

ADC.E l >I.LHI l
Calc.? l >I.LI l
Cal.E (for samples) l ISE.E l
Cal.I l ISE.N l
ClcT.E l na.LHI l
CmpT.? l Over.E l
CmpT.E l Reag.S l
Edited l >Rept/<Rept l
< >ISE l Samp.C l
>I.H l Samp.O l
>I.HI l Samp.S l
>I.I l < >Test l
>I.L l >Test/<Test l
>I.LH l
y Data alarm list ISE module
ADC.E
Alarm ADC abnormal
Description The analog/digital converter is not working normally.
Cause Numerical conversion of the electromotive force is

abnormal.
Remedy 1. If there are other instrument alarms at the same time,

correct those alarms and resume operation.
2. Choose Utility > Maintenance and perform the
maintenance action reset. If the alarm recurs, contact
19 Data alarms
Calc.?
Alarm Calculation not possible
Description The denominator becomes 0 in calculation.

1. During calculation, the denominator became 0.
2. An overflow occurred in logarithmic or exponential
calculation.
3. Result was left blank.
Roche Diagnostics
1162 Data alarms of ISE module tests
Cause Internal calculation error has occurred.
Remedy 1. Check the test that is indicated with an error message

in the calculation.
2. Resume operation. If the data alarm recurs, contact
3. Recalibrate the test.
Cal.E (for samples)

Alarm Calibration result abnormal (for samples)
Description No calibration data or previous calibration data used.
q Cal.E appears on each QC result and test result for

the affected test until the problem is resolved.
Cause An alarm, for example, Std.E, ISE.E, ISE.N, occurred during

calibration.
Remedy 1. Correct the condition that occurred during the latest

calibration and caused the alarm.
2. Recalibrate the test.
Cal.I
Alarm Calibration result invalid
Description The result was generated with an invalid transferred

calibration.
Cause The instrument requested a changeover calibration due to

a change in a reagent cassette for this test, but the
calibration was not performed. Therefore, the reagent
cassette has an invalid calibration until the calibration is
performed.
19 Data alarms
This data alarm is attached to results if a test requires to

be calibrated after replacement of a reagent cassette and
the automatic calibration masking is switched off.
Remedy Calibrate this reagent cassette.
Roche Diagnostics
ClcT.E
Alarm Calculation test error
Description Calculation error has occurred.
Cause A data alarm has occurred for a test needed in the

calculation. However, the ClcT.E alarm is not attached to
the calculated test if one of the following alarms occurred
for a test needed in the calculation:
• Overflow (Over.E)
• Sample carryover for modules (Samp.O)
• Reagent expired date (ReagEx)
• On-board stability limit over on reagent manager
(OBS.RM)
• On-board stability limit over on reagent rotor (OBS.RR)
• Serum index data alarms
Remedy 1. Check the data alarm of the test to be used for the
calculation.
2. Repeat the test.
CmpT.?
Alarm Unable to calculate comp. test (compensation test)
Description During test-to-test compensation calculation, the

denominator became 0. Blank space is left in the report.
Cause 1. The test used for test-to-test compensation has not

been measured yet.
2. A test used for test-to-test compensation has a data
alarm Calculation not possible (Calc.?) or Data error in
comp. test (compensation test) (CmpT.E).
3. A test used in the compensation formula has a data
alarm that leaves the result blank (for example, Samp.S,
Reag.S).
19 Data alarms
Remedy 1. Check the data alarm of the test to be used for

compensation.
2. Repeat the test.
Roche Diagnostics
CmpT.E
Alarm Data error in comp. test (compensation test)
Description 1. In test-to-test compensation calculation, a data alarm

other than those shown below is indicated for the
compensation test data.
2. Calculation not possible, Unable to calculate comp.
test (compensation test), Overflow, QC error, and
outside of expected value.
Cause The test to be used for compensation has a data alarm.
Remedy 1. Check the data alarm on the test to be used for

compensation.
2. Repeat the test.
Edited
Alarm Edited test
Description An edited first result or rerun test result is marked with an

Edited alarm on the Data Review submenu. The alarm is
also printed on the patient report.
Cause The result has been manually changed.
Remedy Check the test result.

19 Data alarms
Roche Diagnostics
< >ISE
Alarm ISE range over
Description If the result is inside the following ranges, the < >ISE data
alarm is attached to the result. This alarm is effective for
urine sample only.
Na+ 10–60 mmol/L
K+ This alarm is not issued.
Cl- 10–60 mmol/L
Cause The sample concentration is low.
Remedy 1. Rerun the test with increased pipetting volume.

The instrument may also be programmed to rerun such
tests automatically.
2. Perform the maintenance action sample probe wash.
3. Clean the outside of the sample probe manually.
4. If the alarm recurs, contact your Roche Service
representative.
>I.H
Alarm Serum index interference hemolysis
Description The hemolytic value is greater than the specified reference

value.
Cause A highly hemolytic sample was measured.
Remedy 1. Check the test results.

2. Repeat the test with new sample material.
>I.HI
19 Data alarms
Alarm Serum index interference hemolysis/icteric
Description The hemolytic and icteric values are greater than the
specified reference values.
Cause A highly hemolytic and icteric sample was measured.

Roche Diagnostics
>I.I
Alarm Serum index interference icteric
Description The icteric value is greater than the specified reference

value.
Cause A highly icteric sample was measured.

>I.L
Alarm Serum index interference lipaemia
Description The lipemic value is greater than the specified reference

value.
Cause A highly lipemic sample was measured.

>I.LH
Alarm Serum index interference lipaemia/hemolysis
Description The lipemic and hemolytic values are greater than the
Cause A highly lipemic and hemolytic sample was measured.

19 Data alarms
>I.LHI
Alarm Serum index interference lipaemia/hemolysis/icteric
Description The lipemic, hemolytic and icteric values are greater than
the specified reference values.
Roche Diagnostics
Cause A highly lipemic, hemolytic, and icteric sample was

measured.

>I.LI
Alarm Serum index interference lipaemia/icteric
Description The lipemic and icteric values are greater than the
Cause A highly lipemic and icteric sample was measured.

ISE.E
Alarm ISE voltage level error
Description During measurement of internal reference, the measured

voltages were not within the following ranges for ISE
Internal Standard:
Na+ -90.0 mV to -10 mV
K+ -90.0 mV to -10 mV
Cl- 80.0–160 mV
If an ISE.E data alarm is detected during an ISE

measurement, the results of the 2 other ISE tests may also
be effected. Therefore, the ISE.E data alarm is attached to
all ISE test results for this sample.
Cause • The reference electrode is deteriorated.

19 Data alarms
• Insulation is poor due to liquid leakage from the

reference electrode mounting section.
• ISE Internal Standard is deteriorated.
Roche Diagnostics
Remedy 1. Replace the reagent and perform the maintenance

action reagent prime for the ISE module.
2. Replace the ISE electrodes and perform the
maintenance action reagent prime for the ISE module.
3. Make sure that the O-ring is attached to the reference
electrode joint and then perform the maintenance
action reagent prime for the ISE module.
4. Replace the ISE Internal Standard bottle and perform
the maintenance action reagent prime for the ISE
module.
5. Check that the reference electrode cords are correctly
connected.
ISE.N
Alarm ISE noise error
Description In ISE measurement, the fluctuation in electromotive force

exceeds the following value:
Na+ 0.7 mV
K+ 1.0 mV
Cl- 0.8 mV
If an ISE.N data alarm is detected during an ISE

measurement, the results of the 2 other ISE tests may also
be effected. Therefore, the ISE.N data alarm is attached to
all ISE test results for this sample. The ISE.N data alarm
takes priority over ISE.E.
Cause • Entry of air bubbles for lack of reagent

• Entry of air bubbles due to improper attachment of ISE
electrode
• Entry of air bubbles through aspiration tubing
• Poor insulation of drain port
• Poor insulation due to liquid leakage from ISE sipper
nozzle
19 Data alarms
Roche Diagnostics
Remedy 1. Check for sufficient reagent volume, make sure that the
tubing sits correctly in the ISE Reference Electrolyte
bottle, and perform the maintenance action reagent
prime for the ISE module (All).
2. Make sure that the O-ring is attached to the ISE
electrode joint and perform the maintenance action
reagent prime for the ISE module (All).
3. Replace the aspiration tubing and perform the
maintenance action reagent prime for the ISE module
(All).
4. Eliminate deposits.
5. Perform cleaning, checkup, and maintenance of the ISE
sipper syringe.
na.LHI
Alarm Serum index measurement not performed
Description The serum index measurement could not be performed for

the test.
Cause The serum index measurement could not be performed for

the test for some reason.
Example 1: The remaining reagent volume for serum index

testing is insufficient.
Example 2: The test is a high-priority immunology test and

the system is in the automatic rerun mode. In that case, the
serum index measurement cannot be performed before the
measurement of the high-priority immunology test.
Remedy 1. Check the remaining amount of reagent for serum index

testing. Replace low reagent, as necessary.
2. If the data alarm is attached to a high-priority
immunology test and the system is in the automatic
rerun mode, rerun the serum index measurement.
19 Data alarms
Over.E
Alarm Overflow
Description Display is not possible because the result exceeds 6 digits

including the decimal point and minus sign.
Roche Diagnostics
Cause The result contains more than 6 digits including the

decimal point and minus sign.
Examples for the maximum number of digits that can be

presented: -0.001 or 123.45 or 123456.
Remedy 1. Check the number of digits of the result. Only 6 digits

including the minus sign and the decimal point are
displayed.
2. Check that the number of decimal places in the
application is appropriate.
3. Dilute the sample and rerun the test.
Reag.S
Alarm Reagent short
Description There is insufficient ISE reagent volume. The liquid level

cannot be detected in the reagent bottle.
Cause There is not enough reagent in the reagent bottle.
Remedy 1. Verify adequate reagent volumes. Replace low reagent,

as necessary. Prime new reagent (if needed) and
recalibrate.
2. If adequate reagent volumes are present, verify
volumes on the Reagent menu. Repeat the test.
3. Resume operation. If the alarm recurs, contact your
>Rept/<Rept
Alarm Repeat limit over (upper)/(lower)
Description The result falls outside the repeat limit range programmed
on Utility > Application > Range.
19 Data alarms
Cause The sample concentration is higher (>Rept) or lower (<Rept)

than the set value.
Remedy This alarm can be activated on Utility > System > Alarm
Settings. If activated, the instrument may also be
programmed to automatically rerun this test with normal
pipetting volume.
Roche Diagnostics
Samp.C
Alarm Sample clot
Description The specified volume of sample is not aspirated.
Cause A clot is detected.
Remedy 1. Perform the maintenance action sample probe wash.

2. Check if there are clots in the sample.
3. If necessary, remove the clots from the sample and
repeat the test.
representative.
Samp.O
Alarm Sample carryover for modules
Description Possible sample carryover must be considered when you

check the results of the additional test(s) because special
wash was not performed in the first run.
Cause An additional test that requires a special wash was

performed and the module did not perform any special
wash for the sample in the first run.
Remedy Repeat the test with a new sample aliquot.
q The second measurement will still have the Samp.O

data alarm if you repeat the test using the same sample ID.
Results with Samp.O data alarms are acceptable when
repeated with a new sample aliquot.
Samp.S
19 Data alarms
Alarm Sample short
Description The liquid level cannot be detected in the sample

container.
Cause The pipetting volume is insufficient in the sample container.
Remedy 1. Add sample and repeat the test.

Roche Diagnostics
< >Test
Alarm ISE sample range over
Description If the result is outside the following ranges, the ISE sample
range over data alarm is issued.
For serum/plasma samples:
Na+ 10–250 mmol/L
K+ 1–100 mmol/L
Cl- 10–250 mmol/L
For urine samples with normal pipetting volume:
Na+ 10–350 mmol/L
K+ 3–100 mmol/L
Cl- 10–350 mmol/L
For urine samples with increased pipetting volume:
Na+ 20–60 mmol/L
K+ The alarm is always attached independent of the

result level.
Cl- 20–60 mmol/L
Cause • The ISE electrode is deteriorated.

• The flow path is contaminated.
• Sample concentration is too high or too low.
Remedy 1. Are QC materials in range?

If Yes, go to 2.
If No, go to 3.
2. Continue with routine analysis. Continue with step 3 at
the end of the day.
19 Data alarms
3. Replace the appropriate ISE electrode.

u Related topics
module (862)
Roche Diagnostics
>Test/<Test
Alarm Technical limit over (upper)/(lower)
Description The sample concentration is outside the technical limit

entered on Utility > Application > Range (ISE tests only).
For serum/plasma samples:

• Over the technical limit: If the result is greater than the
upper limit, a >Test data alarm is attached to the result.
• Under the technical limit: If the result is less than the
lower limit, a <Test data alarm is attached to the result.
• In both cases, a rerun test selection is generated and
an automatic rerun is executed with normal pipetting
volume (15 µL).
For urine samples, this alarm is not generated as long as no

values are entered in the Technical Limit fields on Utility
> Application > Range. Instead, an < >ISE alarm is attached
if the result is outside the measuring range.
Cause Sample concentration is too high or too low.
Remedy 1. Manually dilute the sample and rerun the test with
diluted sample until the measured concentration is
within the specified range. Be sure to calculate the
original concentration from the measured value, using
the correct dilution factor.
3. Clean the outside of the sample probe manually.
If the alarm recurs, contact your Roche Service
representative.
19 Data alarms
Roche Diagnostics
1174 Data alarms of photometric tests
Data alarms of photometric tests
Data alarm c 701/c 702 c 502 Data alarm c 701/c 702 c 502
>Abs l l >Kin l l
ADC.E l l >Lin l l
Calc.? l l MIXLOW l l
Cal.E (for samples) l l MIXSTP l l
Cal.I l l na.LHI l l
ClcT.E l l OBS.RM c 702: l –
c 701: –
CmpT.? l l OBS.RR l l
CmpT.E l l Over.E l l
>Cuvet l l >Proz l l
Det.S l l >React l l
Edited l l ReagEx l l
>I.H l l Reag.S l –
>I.HI l l >Rept/<Rept l l
>I.I l l Samp.? l l
>I.L l l Samp.C l l
>I.LH l l Samp.O l l
>I.LHI l l Samp.S l l
>I.LI l l >Test/<Test l l
y Data alarm list c 701/c 702 and c 502 modules
>Abs
Alarm ABS over
Description The absorbance value is checked for each wavelength. If a

measured absorbance is beyond the limit of 33 000
absorbance units, this data alarm is attached to the result.
Cause • The sample concentration is too high or the sample is

lipemic.
19 Data alarms
• The reagent has not been stored or handled properly.

• Obstructions are in the optical path of the photometer.
Roche Diagnostics
Remedy • If only one sample is affected: Check whether the

sample is grossly lipemic or has a high value. Follow
your laboratory protocol for this situation.
• If only one application is affected: Check reagent
storage and handling for that test.
• If all samples are affected:
- Remove any obstructions in the optical path of the
photometer. Make sure that the lamp is on.
- Choose Utility > Maintenance and perform the
maintenance action incubation water exchange.
- Clean the incubation bath if it is contaminated.
• Choose Utility > Maintenance and perform the
maintenance action photometer check.
• Check the photometer check results on the printout
(Abs < 14 000).
• Replace the photometer lamp, if necessary.
• Resume operation. If the alarm recurs, contact your
• If all samples are affected intermittently:
For example, if any reaction cell is scratched, replace
the reaction cell.
u Related topics
ADC.E
Alarm ADC abnormal
Description The analog-digital converter is not working normally.
Cause 1. Numerical conversion is abnormal.

2. The reaction cell count is abnormal.
Remedy 1. If other instrument alarms exist, correct those alarms

19 Data alarms
and resume operation.

maintenance action reset.
3. If the alarm recurs, remove the reaction disk and check
for water droplets or dust on sensors. Clean if
necessary.
4. If the alarm recurs contact your Roche Service
representative.
Roche Diagnostics
Calc.?

• During calculation the denominator became 0.
• An overflow occurred in logarithmic or exponential
calculation.
• Result was left blank.
Cause Internal calculation error has occurred.
Remedy 1. Check the test that is indicated with an error message

in the calculation. Dilute the sample and rerun the test.
2. Check the Type drop-down list in the Calibration Method
area on Utility > Application > Calib..
3. Resume operation. If the data alarm recurs, contact
Cal.E (for samples)


Cause Any alarm (for example, Std.E) occurred during calibration.
Remedy 1. Correct the condition causing the alarm that occurred

during the latest calibration.
2. Recalibrate.
Cal.I
19 Data alarms

calibration.
Roche Diagnostics

performed.

ClcT.E
Alarm Calculation test error
Description Calculation error has occurred.
Cause A data alarm has occurred for a test needed in the

calculation. However, the ClcT.E alarm is not attached to
the calculated test if one of the following alarms occurred
for a test needed in the calculation:
• Overflow (Over.E)
• Sample carryover for modules (Samp.O)
• Reagent expired date (ReagEx)
• On-board stability limit over on reagent manager
(OBS.RM)
• On-board stability limit over on reagent rotor (OBS.RR)
• Serum index data alarms
Remedy 1. Check the data alarm of the test to be used on the

calculation.
2. Recalibrate.
CmpT.?
19 Data alarms
Alarm Unable to calculate comp. test (compensation test)
Description During test-to-test compensation calculation, the

denominator became 0. Blank space is left in the report.
Roche Diagnostics
Cause 1. The test used for test-to-test compensation has not

been measured yet.
2. A test used for test-to-test compensation has a data
alarm Calculation not possible (Calc.?) or Data error in
comp. test (compensation test) (CmpT.E).
3. A test used in the compensation formula has a data
alarm that leaves the result blank (for example, Samp.S,
Reag.S).
Remedy 1. Check the data alarm of the test to be used for

compensation.
2. Repeat the test.
CmpT.E
Alarm Data error in comp. test (compensation test)
Description 1. In test-to-test compensation calculation, a data alarm

for the compensation test data is indicated.
2. Calculation not possible, Unable to calculate comp.
test (compensation test), Overflow, QC error and
outside of expected value.
Cause The test to be used for compensation has a data alarm.
Remedy 1. Check the data alarm on the test to be used for

compensation.
2. Repeat the test.
>Cuvet
Alarm ABS Cell blank abnormal
Description For a diluted test, the cell blank value of the second
reaction cell exceeds the reference by more than 0.1 Abs.
The reference is the stored value from the cell blank
measurement.
19 Data alarms
If a reaction cell fails the cell blank measurement, the

system excludes it from any measurements.
Roche Diagnostics
For diluted tests, however, the system uses 2 reaction

cells:
• first reaction cell: Contains sample and diluent.
• second reaction cell: Used for discharging diluted
sample from the first reaction cell, adding reagent, and
performing the measurement.
The >Cuvet alarm indicates a failed cell blank measurement

for the second reaction cell.
Cause Reaction cells are contaminated or damaged.
Remedy 1. Check that the reaction cell is not contaminated or

cracked.
maintenance action wash reaction parts.
3. Ensure that there is no excessive foaming or particles in
the incubation bath. If you notice excessive foaming or
particles, perform the maintenance action incubation
water exchange.
4. Wipe the outside of the reaction cells with a gauze pad
moistened with incubation bath water. Perform the
maintenance action incubation water exchange.
5. Resume operation. If the alarm recurs, ensure that
there is adequate rinse water and cell blank water from
the rinse mechanism. The reaction cells must be
completely filled.
6. Resume operation. If the alarm recurs, choose Utility
> Maintenance and perform the maintenance action cell
blank measurement.
If reaction cells are listed in the section abnormal cell
list of the cell blank measurement report, the cell blank
measurement failed. For the reaction cells listed in the
abnormal cell list, the cell blank value differs more than
± 1000 (± 0.1 Abs) compared to reaction cell no. 1.
These reaction cells need to be inspected (or replaced)
and the cell blank measurement must be performed
again.
19 Data alarms
u Related topics
module (907)
Roche Diagnostics
Det.S
Alarm Carryover detergent short
Description If a special wash for the reagent probe is defined, the

reagent probe is immersed in the specified wash solution
cassette. This alarm occurs if the test is carried out even
though the wash solution volume is insufficient.
Cause The remaining volume of the special wash solution is

insufficient.
Remedy 1. Load a new reagent cassette with the wash solution.

2. Check the results of the measurement and repeat the
test if necessary.
Edited
Alarm Edited test

Edited alarm on the Data Review submenu. This is also
printed on the patient report.
>I.H
Description The hemolytic value is larger than the specified reference

value.

19 Data alarms

>I.HI
Description The hemolytic and icteric values are larger than the
Roche Diagnostics

>I.I
Description The icteric value is larger than the specified reference

value.

>I.L
Description The lipemic value is larger than the specified reference

value.

>I.LH
Description The lipemic and hemolytic values are larger than the
19 Data alarms

Roche Diagnostics
>I.LHI
Description The lipemic, hemolytic and icteric values are larger than

measured.

>I.LI
Description The lipemic and icteric values are larger than the specified
reference values.

>Kin
Alarm Kinetic unstable (Prozone error 2)
Description The prozone check value exceeds the specified limit value.
(Reaction rate method)
Cause • The sample concentration is too high. The monotone

kinetic check value exceeds the specified limit for other
tests.
• The limit value is not set properly.
19 Data alarms
Remedy Dilute the sample and rerun the test or rerun the test with a
decreased pipetting volume.
>Lin
Alarm Linearity abnormal
Description In a rate assay, the reaction linearity exceeds the specified

limit value.
Roche Diagnostics
Cause • The photometer lamp has deteriorated.

• The Linearity Limit fields are not set properly in Utility
> Application > Analyze.
• The sample is lipemic.
• The ultrasonic mixers are defective.
• Debris in the incubation bath.
Remedy 1. Check the photometer lamp.

3. Choose Utility > Application > Analyze to check the
settings in the Linearity Limit fields.
4. Choose Utility > Maintenance > 2 Check (on Maintenance
Type list) and perform the maintenance check cuvette
mixing to check the ultrasonic mixing mechanisms.
5. Ensure that the incubation bath is free of debris. Clean
the incubation bath, if necessary.
u Related topics
MIXLOW
Alarm Mixing current low
Description The ultrasonic monitor value is lower than the reference

value.
Cause The ultrasonic mixer is deteriorated.
Remedy 1. Clean the surface of the ultrasonic mixers.

2. Contact your Roche Service representative.
u Related topics
19 Data alarms
• Cleaning the ultrasonic mixers of the c 701 and c 702

modules (936)
• Cleaning the ultrasonic mixers of the c 502
module (1009)
Roche Diagnostics
MIXSTP
Alarm Stop mixing
Description There is no ultrasonic output for mixing.
Cause • The water level in the incubation bath is too low.

• The water level sensor of the incubation bath is
abnormal.
Remedy 1. Supply water to the incubation bath.

2. Contact your Roche Service representative.
na.LHI

the test.




19 Data alarms
OBS.RM (c 702 module only)

Alarm On-board stability limit over on reagent manager
Description The onboard stability for reagent cassettes in the buffer

rotor is set on Utility > Application > Range. The setting is
fixed for each test, for example, 24 hours (which is the
upper limit). The OBS.RM alarm is attached to results if the
onboard stability of a reagent used for this test expired for
more than 30 minutes (e.g., 24 hours + 30 minutes).
Roche Diagnostics
Cause The system detected that the onboard stability of the

reagent cassette on the reagent manager expired.
Remedy 1. Exchange the expired reagent cassette.

2. Check the test results and repeat the test if necessary.
OBS.RR
Alarm On-board stability limit over on reagent rotor
Description The onboard stability of the reagent cassette used for this
test has expired while it was on the reagent disk.
Cause The system detected that the onboard stability of the

reagent cassette expired.

Over.E
Alarm Overflow

including the decimal point and minus sign.
Cause • The K-factor has more than 6 digits due to the use of a
wrong calibrator decimal point.
• The result contains more than 6 digits including the
presented: -0.001 or 123.45 or 123456.

including the minus sign and the decimal point are
displayed.
19 Data alarms
>Proz
Alarm Prozone error
Description The prozone check result exceeds the specified limit.

(Antigen readdition method)
Roche Diagnostics
Cause • The sample concentration is too high.

• The Prozone Limit fields are not set properly.
Remedy 1. Check the reagent preparation.

2. Dilute the sample and rerun the test or rerun the test
with decreased pipetting volume.
3. Choose Utility > Application > Chemistry > Analyze to
check the upper Prozone Limit fields.
>React
Alarm Reaction limit over
Description In a rate assay, the rate of change in main wavelength

absorbance exceeds the automatically corrected limit
value.
Cause • The sample concentration is too high.

• The reagent has been prepared improperly or
deteriorated.
• At Utility > Application > Analyze, there is an improper
setting in the Abs. Limit field or drop-down list.
Remedy 1. Verify the setting in the Abs. Limit field and drop-down
list on Utility > Application > Analyze.
2. Dilute the sample and rerun the test or rerun the test
with a decreased pipetting volume.
3. Prepare fresh reagent.
4. Check the stability and preparation of the reagent.
5. Replace the reagent if necessary.
u Related topics
• About the reaction limit check (>React) (1999)
19 Data alarms
ReagEx
Alarm Reagent expired date
Description The alarm indicates that an expired reagent was used; the
test result is not guaranteed. The alarm can be inactivated
in Utility > System > Alarm Settings.
Cause The system detected an expired reagent on board the

instrument.
Roche Diagnostics
Remedy 1. Check the Reagent Overview dialog box for expired

reagents.
2. Exchange expired reagents.
u Related topics
• Reagent Overview window (ISE module) (1310)
• Reagent Overview window (c 701/c 702 module) (1314)
• Reagent Overview window (e 602 module) (1345)
Reag.S (c 701/c 702 modules only)

Alarm Reagent short
Description For photometric tests, there is insufficient reagent volume

in the reagent cassette, or the liquid level cannot be
detected in the reagent cassette.
Cause • The reagent volume remaining on board is insufficient.

• The reagent probe is not correctly aligned.
• The reagent probe wire is not correctly attached.
Remedy 1. Verify adequate reagent volumes. Replace low reagent,

as necessary. Prime new reagent (if needed) and
recalibrate.
2. If adequate reagent volumes are present, verify
volumes on the Reagent menu.
3. If alarm reoccurs, ensure that the reagent probe is
correctly aligned and the probe wire is attached
correctly.
4. Repeat the test.
>Rept/<Rept
19 Data alarms
Description The result falls outside the repeat limit range programmed
Cause The sample concentration is higher (>Rept) or lower (<Rept)

than the set value.
Remedy This alarm can be activated on Utility > System > Alarm
Settings. If activated, the system may also be programmed
to automatically rerun this test with normal pipetting
volume.
Roche Diagnostics
Samp.?
Alarm ABS maximum over (non-lin curve)
Description The absorbance of a sample is found to be equal or greater

than the theoretical maximum absorbance (for infinite
analyte concentration). The result field is left blank on the
report and Data Review submenu.
Cause The sample concentration is too high.
Remedy Dilute the sample and rerun the test. If automatic rerun is
programmed, the test will be rerun with a decreased
pipetting volume.
Samp.C
Alarm Sample clot
Description The specified volume of sample is not aspirated.

u For more information see Samp.C (1171).
Samp.O
Alarm Sample carryover for modules.

check the results of the additional test(s) because special
wash was not performed in the first run.
Cause An additional test that requires a special wash was

wash for the sample in the first run.

19 Data alarms

Roche Diagnostics
Samp.S
Alarm Sample short

container.
u For more information see Samp.S (1171).
>Test/<Test
Description The sample concentration is outside the technical range

entered on Utility > Application > Range.
• Over the technical limit: Value is greater than the upper
limit (>Test).
• Under the technical limit: Value is less than the lower
limit (<Test).
Cause Sample concentration is too high or too low.
Remedy 1. If >Test appears, decrease pipetting volume for rerun

test.
2. If <Test appears, increase pipetting volume for rerun
test.
3. Choose Utility > Application > Range to check the
Technical Limit fields.
19 Data alarms
Roche Diagnostics
1190 Data alarms of immunology tests
Data alarms of immunology tests
Data alarm e 801 e 602 Data alarm e 801 e 602

ADC.E - l ReagEx l l
Calc.? l l Reag.F l l
Cal.E (for samples) l l Reag.H l l
Cal.I l l Reag.S l l
CarOvr l l Reag.T l l
Cell.T l l >Rept/<Rept l l
Clot.E – l Samp.B l l
>Curr l l Samp.C l l
Edited l l Samp.O l l
>I.H – l Samp.S l l
>I.HI – l <SigL l l
>I.I – l SLLD.E l l
>I.L – l SLLD.N l l
>I.LH – l SysR.S – l
>I.LHI – l SysR.T l l
>I.LI – l >Test/<Test l l
Inc.T l l WB.S – l
na.LHI – l WBSS.T l –
OBS.RR l l WB.T l l
Over.E l l
y Data alarm list for e 801/e 602 modules
ADC.E (e 602 module only)

Alarm ADC abnormal
Description The analog/digital converter is not working normally.
Cause Numerical conversion of the output from the

photomultiplier in a measuring channel is abnormal.
19 Data alarms
Remedy 1. If there are other instrument alarms at the same time,

correct those alarms and resume operation.
maintenance action reset. If the alarm recurs, contact
Roche Diagnostics
Calc.?
Cause Internal calculation error occurred.
Remedy Repeat the test.
Cal.E (for samples)


Cause • There is no valid calibration stored in the system.

• The attempted calibration has failed.
• Previous calibration data was used to calculate this
result.
Remedy 1. Correct the condition causing the alarm that occurred

during the latest calibration.
2. Check the calibrators and the reagent cassette and
repeat the calibration.
3. Replace with new calibrators and a new reagent
cassette, if necessary. Repeat the calibration.
4. Repeat the test.
19 Data alarms
Cal.I

calibration.
Roche Diagnostics

performed.

CarOvr
Alarm Potential carryover
Description The signal level of this sample is low, a carryover in the

measuring cell may have occurred.
Cause Microbead carryover from the previous test may have

occurred.
Exception: The potential microbead carryover data alarm

was set, yet had no impact on a clinical decision.
Remedy 1. Repeat the test.

2. Exception only in one of the following cases:
1) Qualitative test results are below cutoff
2) Quantitative test results are below the lower limit of
the clinical decision
Cell.T
Alarm Cell temperature
Description Measuring cell temperature is out of range. The system

performs an initial check 30 minutes after startup. The
19 Data alarms
temperature is checked continuously thereafter.
Cause • The reagent disk cover is open. Radiation of heat does

not work normally.
• The room temperature is out of range.
Remedy 1. Verify the temperature of ProCell/CleanCell solution.

Check that the fans at the rear of the module are
operating normally and are unobstructed.
2. Check that room temperature is 18–32 °C.
representative.
Roche Diagnostics
Clot.E (e 602 module only)

Alarm Clot pressure abnormal
Description In checking the pressure sensor, overflow data is detected.
Cause There are air bubbles in the water flow tubing.
Remedy 1. Choose Utility > Maintenance and perform the

maintenance action pipetter air purge (10 cycles).
2. Repeat the test with new sample material. Or
centrifuge the sample and then repeat the test.
representative.
>Curr
Alarm Current range over
Description The current from the measuring cell is out of range when
checked during operation.
Cause Abnormal measuring cell condition.

• There are air bubbles in the PC cup.
• The electrode of the measuring cell is contaminated or
deteriorated.
Remedy 1. Check for air bubbles in the PC cup.

2. Replace with a new ProCell bottle, if necessary.
maintenance action liquid flow cleaning (1 cycle).
During operation:
maintenance action MC preparation (10 cycles).
2. Repeat the test.
3. If the alarm recurs immediately, contact your Roche
19 Data alarms
Edited
Alarm Edited test

Edited alarm on the Data Review submenu. This is also
printed on the patient report.
Roche Diagnostics
>I.H (e 602 module only)

Description The hemolytic value is greater than the specified reference

value.

>I.HI (e 602 module only)

Description The hemolytic and icteric values are greater than the

>I.I (e 602 module only)

Description The icteric value is greater than the specified reference

value.
19 Data alarms

Roche Diagnostics
>I.L (e 602 module only)

Description The lipemic value is greater than the specified reference

value.

>I.LH (e 602 module only)

Description The lipemic and hemolytic values are greater than the

>I.LHI (e 602 module only)

Description The lipemic, hemolytic, and icteric values are greater than

measured.

19 Data alarms
>I.LI (e 602 module only)

Description The lipemic and icteric values are greater than the
Roche Diagnostics

Inc.T
Alarm Incubator temperature
Description The temperature of the incubator disk is out of range. The

system performs an initial check 30 minutes after startup.
The temperature is checked continuously thereafter.
Cause • Radiation of heat does not work normally.

Remedy 1. Check the fans at the rear of the module are operating
normally and are unobstructed.
3. Repeat the test.
representative.
na.LHI (e 602 module only)


the test.



19 Data alarms


Roche Diagnostics
OBS.RR
Alarm On-board stability limit over on the reagent cassettes
Description The on-board stability of a reagent cassette (e 801 or

e 602 module) used for this test has expired.
Cause The system has detected that the on-board stability of a

reagent cassette has expired.

Over.E
Alarm Overflow

(e 602 module) or 8 digits (e 801 module) including the
Cause The result contains more than 7 digits (e 602 module) or

8 digits (e 801 module) including the decimal point and
minus sign.

presented:
• e 602 module: -0.0012 or 12.3456 or 1234567
• e 801 module: -0.00123 or 12.34567 or 12345678

(e 602 module) or 8 digits (e 801 module) including the
minus sign and the decimal point are displayed.
19 Data alarms
ReagEx
Alarm Reagent expired date
Description The alarm indicates that an expired reagent was used; the
test result is not guaranteed. The alarm can be inactivated
in Utility > System > Alarm Settings.
Roche Diagnostics
Cause The system detected an expired reagent onboard the

instrument.
Remedy 1. Expired reagents are listed in the Reagent Load/Unload

List as Expired in the Reason column.
2. Exchange expired reagents.
Reag.F
Alarm Reagent film or foam detection
Description The reagent probe detects a film or air bubbles in the

reagent cassette.
Cause There is foam or film in the reagent cassette, the diluent

cassette, or the pretreatment cassette.
Remedy Remove foam or film with a stick made of non-absorbent

material, e.g., a pipette (without aspirating reagent), or
wait until the foam disappears. Avoid losing reagent
volume. Otherwise, the reagent cassette may not be
accepted by the system.
Reag.H
Alarm Reagent hovering
Description The reagent probe hovers over the reagent disk.
Cause A premature LLD signal is detected during reagent

pipetting.
Remedy 1. Dry the lids on the affected reagent cassette.

2. Check for air bubbles in the affected reagent cassette.
maintenance action reset.
19 Data alarms
representative.
Reag.S
Alarm Reagent, diluent, or pretreatment short
Description The liquid level cannot be detected in the reagent

cassette.
Roche Diagnostics
Cause • There is no reagent in the reagent cassette.

• The volume of diluent or pretreatment is insufficient.
• The lead wire for the liquid level sensor is disconnected.
Remedy 1. Verify that reagent, diluent, and pretreatment are

adequate.
1) If the volume is not adequate, replace the low
reagent cassette and perform a reagent scan.
2) If the volume is adequate, verify volumes on the
Reagent Overview dialog box.
2. Verify that the lead wire is connected.
3. Resume operation and repeat the test.
representative.
Reag.T
Alarm Reagent disk temperature
Description Reagent disk temperature is out of range. The system

Cause • Radiation of heat does not work normally.

Remedy 1. Verify that the reagent disk cover is securely in place.

2. Check that the fans at the rear of the module are
representative.
>Rept/<Rept
19 Data alarms
Description The result is greater than the specified upper limit (>Rept)
or smaller than the lower limit (<Rept) programmed on
Utility > Application > Range.
Roche Diagnostics
Cause • The sample concentration is higher than the set value

(>Rept).
• The sample concentration is lower than the set value
(<Rept).
• An improper repeat limit range is specified.
Remedy 1. Rerun the test and check the measured value.

2. Specify a proper range in the Repeat Limit fields on
Utility > Application > Range.
Samp.B
Alarm Sample air bubble
Description • Air bubble/foam is detected in the sample when the

sample is aspirated.
• Air bubble is detected in the sample syringe flow path
when the sample is aspirated (e 602 module only).
• Foam is detected in the sample with the camera (e 801
module only).
Cause • There are air bubbles/foam in the sample container.

• There are droplets on the sample container wall.
• There are air bubbles/foam in the water flow tubing.
• There are clots or other particles in the sample
container (e 801 module only).
• The sample volume is insufficient.
• The sample container type is not supported.
• The sample container is tilted or not centered.
Remedy 1. Please check alarm message.

2. Remove air bubbles/foam, clots or other particles from
the sample tube with a cotton swab or pipette.
3. Check the positioning of the sample container on the
rack and tube.
4. Check the volume in the sample container.
5. Check the sample container type.
19 Data alarms
6. If the alarm recurs, choose Utility > Maintenance and

perform the maintenance action (22) Pipetter Air Purge
(10 cycles).
7. Repeat the tests.
8. If the alarm recurs, contact your Roche service
representative.
Roche Diagnostics
Samp.C
Alarm Sample clot
Description A sample clot is detected during aspiration.
Cause • The pipetting volume is insufficient.

• There are clots in the sample.
Remedy 1. Fill the required volume into the sample container.

2. Check sample for fibrin.
3. Remove any clots or centrifuge the sample and then
repeat the test.
4. If clots could not be removed, rerun the test with new
sample material.
Samp.O
Alarm Sample carryover for modules.

check the results of the additional test(s) because no
special wash was performed in the first run.
Cause • An additional test that requires a special wash was

wash for the sample in the first run, or the sample has
been processed on the ISE module or a clinical
chemistry module.
• A high priority immunology test is run manually after the
sample has already been processed on the ISE module
or a clinical chemistry module.

19 Data alarms
Samp.S
Alarm Sample short

container.
Roche Diagnostics
Cause • The pipetting volume in the sample container is

insufficient.
• The sample container is missing on the rack.
Remedy 1. Load the sample, if it is not on board.

2. Check the pipetting volume, add the required sample
volume, and repeat the test.
3. Resume operation.
representative.
<SigL
Alarm Minimum signal
Description The signal level is extraordinarily low.
Cause • The volume of the reaction mixture in the AssayCup is

insufficient
• Reaction mixture contains clots
• Extremely high sample concentration for a competitive
assay
• Abnormal measuring cell condition of detection unit
(sipper/tubing/MC)
• ProCell is expired
Remedy 1. Repeat the test.

OR: Rerun the test with manually diluted sample.
2. Replace ProCell if expired.
representative.
SLLD.E
Alarm Sample LLD abnormal
19 Data alarms
Description The sample probe does not start LLD or LLD is not
completed.
Cause 1. The tip of the sample probe is dirty.

2. The tip of the sample probe is wet.
Roche Diagnostics
Remedy 1. Clean the tip of the sample probe and repeat the test. If
the alarm recurs, contact your Roche Service
representative.
2. Dry the tip of the sample probe and repeat the test. If
the alarm recurs, contact your Roche Service
representative.
SLLD.N
Alarm Sample LLD noise
Description The sample probe detects noise or air bubbles on the

sample.
Cause 1. The pipetting volume is insufficient.

2. There are air bubbles in the sample container.
Remedy 1. Check pipetting volume.

2. Remove the air bubbles with a cotton swab.
3. Repeat the test.
SysR.S (e 602 module only)
Alarm System reagent short
Description The counted remaining number becomes 0 or a liquid short

signal is detected.
Cause The remaining volume in the ProCell and/or CleanCell

bottles is insufficient.
Remedy 1. Check the volumes in the ProCell/CleanCell bottles and

replace, if necessary.
3. Repeat the test.
19 Data alarms
SysR.T
Alarm System reagent temperature
Description ProCell/CleanCell temperature is out of range. The system

Roche Diagnostics
Cause 1. Radiation of heat does not work normally.

2. The room temperature is out of range.
Remedy 1. Check the fans at the rear part of the module are
operating normally and are free of obstructions.
representative.
>Test/<Test
Description • Upper technical limit exceeded:

The measured value is higher than the measuring range
(>Test).
• Lower technical limit exceeded:
The measured value is lower than the measuring range
(<Test).
Cause • The sample concentration is above the upper limit of

the measuring (reportable) range (>Test).
• The sample concentration is below the lower limit of the
measuring (reportable) range (<Test).
Remedy 1. If >Test, rerun the test using the recommended dilution

factor and check the test result.
2. If <Test, report the test result as less than the limit of
detection of the test. Rerun test is not requested.
WB.S (e 602 module only)

Alarm Washing buffer short
Description The remaining volume for PreClean is 0, or liquid short

19 Data alarms
signal is detected.
Cause The remaining volume in the PreClean bottles is

insufficient.
Remedy 1. Replace with a new PreClean bottle.

3. Repeat the test.
Roche Diagnostics
WBSS.T (e 801 module only)

Alarm Washing buffer SS temperature
Description The temperature of PreClean II M solution at the

separation station is out of range. The instrument performs
an initial check 30 minutes after startup. The temperature
is checked continuously thereafter.

Remedy 1. Check that the fans at the rear of the module are
representative.
WB.T
Alarm Washing buffer temperature
Description PreClean temperature is out of range. The instrument


Remedy 1. Check that the fans at the rear of the module are
representative.
19 Data alarms
Roche Diagnostics
1206 Alarms for calibrations
Alarms for calibrations

The following table displays all calibration data alarms
applicable for the modules. Most of the alarms indicate
that one calibration quality criterion has not been met.
Indication of calibration data alarms Calibration data alarms are indicated on the Calibration
Trace dialog box and on the calibration monitor report.
For the e 801/e 602 module, calibration alarms are always

indicated by an asterisk (*) on the Calibration Trace dialog
box. This is used as a wildcard for all calibration data
alarms. Check the calibration monitor report to find out
which calibration data alarm occurred.
u Automatic Calibration Monitor report (1454)
Calibration Monitor report (cobas e modules) (1459)
Data alarm Data alarm (long name) ISE c 701/c 702 c 502 e 801 e 602
Cal.E CALIB error (for calibrations) l l l – –
Cond.E Conditioning (ISE) abnormal l – – – –
Diff.E Minimum acceptable difference – – – l l
Dup.E Duplicate error – l l l l
IStd.E IS concentration abnormal l – – – –
MAX Maximum Signal – – – l –
MIN Minimum Signal – – – l –
Mono.E Monotony of curve – – – – l
Prep.E Preparation abnormal l – – – –
Rsp1.E Response (ISE) abnormal 1 l – – – –
Rsp2.E Response (ISE) abnormal 2 l – – – –
S1A.E S1ABS abnormal – l l – –
SD.E SD limit error – l l – –
Sens.E Sensitivity error – l l – –
>Sig Maximum Signal – – – – l
<Sig Minimum Signal – – – – l
Sig.E Minimum/Maximum Signal – – – l l
Slop.E Slope abnormal l – – – –
Std.E Standard error l l l – –
Sys.E System errors – – – l l
19 Data alarms
y Data alarm list
u Overview of calibration quality criteria for ISE

tests (1954)
Overview of calibration quality criteria for photometric
tests (1976)
tests (1981)
Roche Diagnostics
Cal.E
Alarm CALIB error (for calibrations)
Displayed in Calibration > Status > Calibration Trace.
Description The current slope value differs from the previous one by
more than the specified compensated limit on Utility
> Application > Calib.. The Compensated Limit field is a limit
for the difference
| previous value – current value | expressed as percentage
of the average (previous value + current value)/2.
For ISE calibrations, the S3 concentration is checked

additionally by applying a limit to the Compensated Limit
field multiplied by a factor of 0.25. If this check fails, the
Cal.E alarm is also issued.
q The Cal.E alarm is a warning only, and does not

necessarily indicate a calibration problem. Check the test’s
control recovery before accepting the new calibration
result.
Cause • The calibrator solution or reagent is not placed in

proper position.
• The reagent has deteriorated or the calibrator solution
has become concentrated due to evaporation.
Remedy 1. Correct any other instrument and/or data alarms.

2. Check calibrators, reagents, and QC materials. If QC
materials are in range, and calibrators and reagents are
acceptable, resume operation. Otherwise, correct
abnormalities and recalibrate.
3. For ISE, check the set Compensated Limit field on Utility
> Application > Calib..
19 Data alarms
Roche Diagnostics
Cond.E
Alarm Conditioning (ISE) abnormal
Description The slope value is 68.1 mV or greater for Na+ or K+

electrodes, or it is -68.1 mV or less for the Cl- electrode.
The conditioning is inadequate.
Slope value Alarm message

- + +
Cl K Na
-68.1 mV or less 68.1 mV or more 68.1 mV or more Conditioning inadequate Cond.E
-68.0 mV to -40.0 mV 68.0 mV to 50.0 mV 68.0 mV to 50.0 mV (Normal range)
-39.9 mV to -35.0 mV 49.9 mV to 45.0 mV 49.9 mV to 45.0 mV ISE prepare error Prep.E
-34.9 mV or more 44.9 mV or less 44.9 mV or less ISE slope error Slop.E
y Slope values for ISE electrodes
Na+, K+
Slope.E Prep.E (Normal range) Cond.E
+40 +45 +50 +55 +60 +65 +68 mV
Cl-
Cond.E (Normal range) Prep.E Slope.E
-68 -65 -60 -45 -40 -35 -30 mV
w ISE data alarms and corresponding slope values (electrode voltage)
q Judgment on ISE electrode replacement

o If one of the alarms Preparation abnormal (Prep.E) or
ISE slope error (Slop.E) appear during calibration,
replace the ISE electrodes at once.
o Normally, the slope values slightly decrease with time
and use. If there is a large change compared to the
value of the previous day, the cause may be other than
deteriorated ISE electrodes. Check for air bubbles in or
leakage from the flow path, an error in substitution of
ISE Standard Low and ISE Standard High solution,
contamination of the flow path, etc.
19 Data alarms
Cause • Conditioning of a new ISE electrode is unsatisfactory.

• The concentration of ISE calibrators is improper.
Remedy 1. Perform washing with wash rack with Activator on the

third position.
2. Pour fresh calibrators ISE Standard Low and
ISE Standard High into containers. Place containers on
calibrator rack and recalibrate the ISE units.
Roche Diagnostics
Diff.E
Alarm Minimum acceptable difference
Description If the difference between the mean of calibrator 1 and

calibrator 2 is below the permissible value, the calibration
is failed.
Cause • ProCell is expired.

• The calibrator does not reach room temperature.
Remedy 1. Replace ProCell.

2. Set the calibrator appropriately.
3. Recalibrate.
Duplicate error
This section describes the duplicate error for cobas c
modules and for cobas e modules.
Dup.E (cobas c modules)

Alarm Duplicate error
Displayed on Calibration > Status > Calibration Trace.
Description The difference between the first and second measurement

(absorbance) of a calibrator is outside the specified range.
The following steps describe how a decision is made to

mark a calibration for violating the duplicate limit.
1. The absorbance for a calibrator (N) is measured twice.
2. The % of error and absorbance error are computed.
3. Is the absorbance error smaller than the set Duplicate
Limit Abs. field on Utility > Application > Calib.?
If no, go to step 5.
19 Data alarms
If yes, go to step 4.
4. Continue with result calculations. No Dup.E alarm is
issued.
5. Is the % error < the % Duplicate Limit?
If no, go to step 6.
If yes, go to step 4.
6. Dup.E alarm is issued for this result.
Roche Diagnostics
Cause The difference between the first and second measurement

(absorbance) of a calibrator is greater than Duplicate Limit
Abs and greater than the % Duplicate Limit.
Remedy 1. Recalibrate.
2. Check reagent storage, handling, and expiry date.
Replace the reagent if necessary and recalibrate.
representative.
q If this alarm occurs, a Std.E alarm is issued. The Std.E

alarm prevents updating of calibration for the affected
test.
Dup.E (cobas e modules)

Alarm Duplicate error (e 801/e 602)
Displayed on Calibration > Status > Calibration Result.
Description The difference between the first and second measured

signal of the calibrator is out of the specified range.
For e 801 modules: The duplicate limit is defined lot-
specific in the container parameter file.
For e 602 modules: The duplicate limit is defined on Utility
Cause • Air was aspirated during the first measurement due to

air bubbles on the corresponding calibrator. During the
second measurement, no air was aspirated.
• Consequence: The signal values of the first and second
measurement differ more than the specified
percentage.
Remedy Verify that there are no air bubbles on the surface of the
calibrator and perform a new calibration.
19 Data alarms
Roche Diagnostics
IStd.E
Alarm IS concentration abnormal
Description The concentration of the ISE Internal Standard solution

was not within the following ranges:
Na+ 120.0–160.0 mmol/L
K+ 3.0–7.0 mmol/L
Cl- 80.0–120.0 mmol/L
Cause • The flow path is contaminated.

• The reagent has deteriorated.
Remedy 1. If the measured voltage of ISE Internal Standard

(IS EMF) is abnormal on the calibration monitor report,
check the reagent volume of ISE Internal Standard. If
necessary, perform a reagent prime and recalibrate.
2. If the measured voltage of ISE Internal Standard
(IS EMF) is normal on the calibration monitor report,
check ISE reagent syringe. The measured voltage of ISE
Internal Standard ideally lies midway between
ISE Standard Low and ISE Standard High. The ideal
concentration values of ISE Internal Standard are: Na+:
140 mmol/L; K+: 5 mmol/L; Cl-: 100 mmol/L.
3. Perform the maintenance action reagent prime for the
ISE module to wash the flow path.
4. Replace the ISE Internal Standard bottle and
recalibrate.
19 Data alarms
Roche Diagnostics
MAX
Alarm Maximum Signal
Description The calibrator signal is greater than the specified upper

limit.
For e 801 modules: For qualitative and quantitative

immunology tests.

• The calibrator was mixed up.
Remedy 1. Replace the ProCell bottle.

2. Place the calibrator appropriately.
3. Recalibrate.
MIN
Alarm Minimum Signal
Description The calibrator signal is lower than the specified lower limit.
For qualitative and quantitative assays.

• Failure during reconstitution of the calibrator.

3. Recalibrate.
Mono.E (e 602 module only)

Alarm Monotony of curve
19 Data alarms
Description The working curve is not monotonically increasing or

monotonically decreasing.
This is a calibration quality criterion only for quantitative

immunology tests.

• The calibrator did not reach room temperature.
Remedy 1. Replace ProCell.

Roche Diagnostics
Prep.E
Alarm Preparation abnormal
Description The slope value is within the following range: 45.0-49.9 mV

for Na+ or K+ electrodes, -39.9 mV to -35.0 mV for the Cl-
electrodes. This alarm causes a failed calibration.
Na+, K+
+40 +45 +50 +55 +60 +65 +68 mV
Cl-
-68 -65 -60 -45 -40 -35 -30 mV

• The flow path is contaminated.
Remedy 1. Replace the ISE electrode.

2. Perform the maintenance action reagent prime to prime
the reagent tubings.
3. Prepare fresh calibrator; place on calibrator rack and
recalibrate the ISE units.
u For more information on ISE calibration alarms, see:
Cond.E (1208).
Rsp1.E
Alarm Response (ISE) abnormal 1
19 Data alarms
Description The compensation factor is over the limits (narrower

range).

• The ISE electrode is contaminated or deteriorated.
Roche Diagnostics
Remedy 1. Check QC materials for correct fill levels.

2. If incorrect, go to step 3 before continuing routine
analysis.
If correct, go to step 3 after finishing routine analysis at
the end of the day.
3. To wash the flow path, choose Utility > Maintenance and
perform the maintenance action ISE system wash.
4. Perform washing with wash rack with SysClean (pos. 2)
and Activator (pos. 3).
recalibrate the ISE units.
6. Resume operation. If the alarm recurs, repeat steps 3
to 5 a maximum of 2 times. If the alarm recurs, replace
the ISE electrodes.
Rsp2.E
Alarm Response (ISE) abnormal 2
Description The compensation factor is over the limits (wider range).

• The ISE electrode is contaminated or deteriorated.
Remedy u See Rsp1.E (1213).
S1A.E
Alarm S1ABS abnormal
Description During calibration, expected absorbance is outside the S1

Abs Limit. S1 is read bichromatically for endpoint assays,
monochromatically for rate assays.
19 Data alarms
Cause • The reagent has been stored or handled improperly or

has deteriorated.
• An improper absorbance range is specified for
calibrator 1.
Remedy 1. Check reagent storage and handling and calibrator

preparation, if applicable.
2. Recalibrate.
3. Check the values in the S1 Abs. Limit fields on Utility
Roche Diagnostics
SD.E
Alarm SD limit error
Description During nonlinear or multi-point linear calibration, the

SD value was greater than the SD limit programmed on
Utility > Application > Calib..
Cause • The calibrator is not placed in a correct position.

• An improper SD limit value is specified.
Remedy 1. Check calibrator positions on Calibration > Calibrators.

2. Choose Utility > Application > Calib. to check the SD
Limit field.
3. Check reagent storage and handling and calibrator
preparation. Recalibrate the affected test.
4. Check the calibrator concentrations on Calibration
> Install. For a calibration with automatic calibrator
dilution, check whether the ratio between calibrator
concentration, calibrator volume, diluent volume, and
diluted calibrator volume is correct on Utility
> Application > Other.
Sens.E
Alarm Sensitivity error
Description Sensitivity is checked for linear (2–6 points), nonlinear, or

isozyme-P calibration. This alarm is indicated if the
sensitivity value obtained in a calibration falls out of the
Sensitivity Limit fields specified on Utility > Application
> Calib..
q For span calibration, the previous S1 Abs (linear) or

previous mean absorbance (nonlinear) of calibrator (1) is
used for the sensitivity limit check.
19 Data alarms
Cause • The calibrator is not placed in a proper position.

• The reagent has been prepared improperly or has
deteriorated.
• An improper sensitivity limit is specified.
Roche Diagnostics
Remedy 1. Check preparation and expiry dates of calibrators and

reagents. Recalibrate the affected test.
2. Check sample pipetter for leaks and recalibrate the
affected test.
3. Choose Utility > Application > Calib. to check the
Sensitivity Limit fields and recalibrate the affected test.
>Sig
Alarm Maximum Signal
Description The calibrator signal is greater than the specified upper

limit.
For e 602 modules: Only for qualitative immunology tests.


3. Recalibrate.
<Sig
Alarm Minimum Signal
Description The calibrator signal is lower than the specified lower limit.
For qualitative and quantitative assays.

• Failure during reconstitution of the calibrator.
19 Data alarms

3. Recalibrate.
Roche Diagnostics
Sig.E
Alarm Minimum/Maximum Signal
Description The measured signal of a calibrator for a qualitative test

should fall between the designated minimum and maximum
signal. If one or more values fall out of the allowable
minimum/maximum signal range, the calibration fails.
Cause The measured signal of a calibrator for a qualitative test

lies outside the designated minimum/maximum signal
range.
Remedy 1. Check the calibrators and reagents and repeat the

calibration.
2. Set new calibrators and a new reagent cassette, if
necessary, and repeat calibration.
Slop.E
Alarm Slope abnormal (ISE only)
Description The slope value is less than 45.0 mV for Na+ or K+

electrodes, or greater than -35 mV for the Cl- electrode.
This alarm causes a failed calibration.
Na+, K+
+40 +45 +50 +55 +60 +65 +68 mV
Cl-
-68 -65 -60 -45 -40 -35 -30 mV

19 Data alarms

• ISE Standard Low and ISE Standard High are not placed
in the proper positions.
• The sample probe is clogged.
Roche Diagnostics
Remedy 1. Replace the appropriate ISE electrode before

continuing routine analysis.
2. Perform washing with wash rack with Activator on the
third position.
recalibrate the ISE module.
u For more information on ISE calibration alarms, see:
Cond.E (1208).
Std.E
This section describes the Std.E data alarm for the ISE
module and for cobas c modules.
Std.E (ISE module)

Alarm Standard error
Description Two cases must be distinguished:

• Case 1: During ISE calibration, one of the alarms listed
in table occurred.
• Case 2: During calibration, calculation was disabled.
Table for case 1:

Data alarm (long name) Data alarm
ADC abnormal ADC.E
Calculation not possible Calc.?
ISE voltage level error ISE.E
ISE noise error ISE.N
Mixing current low MIXLOW
Sample short Samp.S
y Data alarms causing a Std.E alarm when occurring in
calibration
19 Data alarms
q The calibration is not updated if this alarm is issued;

i.e., the prior calibration remains in effect.
Cause • The reagent is empty and has to be replaced.

• The concentration of calibrator is incorrect or the
calibrator is not placed in the proper position.
• An improper check value is specified.
Roche Diagnostics
Remedy 1. Correct all other instrument and/or data alarms.

2. Prepare fresh calibrator, place on the rack, and
recalibrate.
3. Replace reagent, prime, and recalibrate.
calibration parameters.
Std.E (cobas c modules)

Alarm Standard error
Description Three cases must be distinguished:

• Case 1: During photometric calibration, one of the
alarms listed in the table occurred.
• Case 2: During calibration, calculation was disabled.
• Case 3: During nonlinear calibration, an extreme value
appeared.
Table for case 1:

Data alarm (long name) Data alarm
ABS over >Abs
ADC abnormal ADC.E
Calculation not possible Calc.?
ABS Cell blank abnormal >Cuvet
Duplicate error Dup.E
Linearity abnormal >Lin
Mixing current low MIXLOW
Stop mixing MIXSTP
Prozone error, Kinetic unstable >Proz, >Kin(1)
(Prozone error 2)
Reaction limit over >React
Reagent short Reag.S
S1ABS abnormal S1A.E
Sample short Samp.S
y Data alarms causing a Std.E alarm when occurring in
19 Data alarms
calibration
(1) Not for Std.1
q The calibration is not updated if this alarm is issued;

i.e., the prior calibration remains in effect.
Roche Diagnostics
Cause • The reagent has not been stored or handled properly or

is empty and has to be replaced.
• The concentration of calibrator is incorrect or the
calibrator is not placed in the proper position.
• An improper check value is specified.
Remedy 1. Correct all other instrument and/or data alarms.

2. Prepare fresh calibrator, place on the rack, and
recalibrate.
3. Replace reagent and recalibrate.
calibration parameters.
Sys.E
Alarm System errors
Description An error occurred on the system during measurement.
Cause Check the Alarm window.
Remedy 1. Eliminate problems with the instrument, referring to the

Alarm window.
representative.
19 Data alarms
Roche Diagnostics
Data alarm for QC materials

QC results are validated on the data manager regarding
the set rules. After validation is performed, the QC results
are transferred back to the instrument.
q On the instrument, invalid QC results are always

attached with the QCErr data alarm. Check the data
manager for details.
Data alarm Alarm ISE c 701/c 702 c 502 e 801/e 602

QCErr QC error l l l l
y Data alarm list
QCErr
Alarm QC error
Description • The QC result is not within the defined range.

• No QC rule is assigned to the test.
• There are not enough QC values available for applying
the assigned QC rule.
Cause • Reagent is deteriorated.

• Poor precision due to leakage of the pipetter joint.
• Proper QC values (mean value, standard deviation) are
not specified.
• Improper preparation or storage of QC materials.
• Missing QC rule assignment.
• Missing QC values.
Remedy 1. Check that the QC materials are properly prepared,

positioned, and stored.
2. Check that the target value and SD for the specified
test are entered correctly on the data manager
component QC Parameter.
19 Data alarms
3. Register a new reagent cassette.

4. Prepare new QC materials.
5. Assign a QC rule to the test.
6. Perform more QC measurements.
Roche Diagnostics
1222 Data alarm for QC materials
List of data alarms for QC measurements

The following table displays the data alarms that can be
attached to QC results in addition to the QCErr alarm.
>Abs ABS over – l l l – –
ADC.E ADC abnormal l l l l – l
Calc.? Calculation not possible l l l l l l
Cal.E (for samples) Calibration result abnormal (for samples) l l l l l l
Cal.I Calibration result invalid l l l l l l
CarOvr Potential carryover – – – – l l
Cell.T Cell temperature – – – – l l
ClcT.E Calculation test error l l l l – –
Clot.E Clot pressure abnormal – – – – – l
CmpT.? Unable to calculate comp. test (compensation test) l l l l – –
CmpT.E Data error in comp. test (compensation test) l l l l – –
>Curr Current range over – – – – l l
>Cuvet ABS Cell blank abnormal – l l l – –
Det.S Carryover detergent short – l l l – –
Inc.T Incubator temperature – – – – l l
ISE.E ISE voltage level error l – – – – –
ISE.N ISE noise error l – – – – –
>Lin Linearity abnormal – l l l – –
MIXLOW Mixing current low – l l l – –
MIXSTP Stop mixing – l l l – –
OBS.RM On-board stability limit over on reagent manager – – l – – –
OBS.RR On-board stability limit over on reagent rotor – l l l l l
Over.E Overflow l l l l l l
>React Reaction limit over – l l l – –
ReagEx Reagent expired date – l l l l l
Reag.F Reagent film or foam detection – – – – l l
Reag.H Reagent hovering – – – – l l
Reag.S Reagent short l l l – l l
Reag.T Reagent disk temperature – – – – l l
19 Data alarms
Samp.? ABS maximum over (non-lin curve) – l l l – –

Samp.B Sample air bubble – – – – l l
Samp.C Sample clot l l l l l l
Samp.O Sample carryover for modules l l l l l l
Samp.S Sample short l l l l l l
<SigL Minimum signal – – – – l l
SLLD.E Sample LLD abnormal – – – – l l
SLLD.N Sample LLD noise – – – – l l
SysR.S System reagent short – – – – – l
SysR.T System reagent temperature – – – – l l
Roche Diagnostics
< >Test ISE sample range over l – – – – –
>Test/<Test Technical limit over (upper)/(lower) – – – – l l
WB.S Washing buffer short – – – – – l
WBSS.T Washing buffer SS temperature – – – – l –
WB.T Washing buffer temperature – – – – l l
19 Data alarms
Roche Diagnostics
1224 Data problems without alarm
Data problems without alarm

This chapter provides general information about data
problems on the instrument without alarm.
Drift of result data

Cause • Concentration or deterioration of sample
• The calibrator is concentrated or deteriorated.
• The ISE flow path is contaminated. (ISE module)
Remedy 1. Avoid leaving the sample in the container for extended

periods.
2. Perform the maintenance action ISE system wash.
Erroneous operation
Cause • Neglect of preliminary or periodical check(s).
• Carryover between tests.
• Fibrin contained in sample or dust contained in reagent.
• The sample container used was not recommended.
Remedy 1. Carry out preliminary and/or periodical check

according to the specified procedure.
2. Change the measuring channel, use the wash program,
or take any other measure after consulting with the
reagent manufacturer.
3. Eliminate fibrin or dust. Be sure to check the sample
and reagent before setting them.
5. Use the recommended sample container.
19 Data alarms
Roche Diagnostics
Poor reproducibility
Cause • A maintenance action is overdue.
• Deterioration of reagent or precipitation of insoluble
matter.
• Deterioration of ProCell, CleanCell, or PreClean.
• Poor deionized water quality.
• Incorrect reagent handling.
• Test parameters are not set properly.
Remedy 1. Carry out daily checks and periodical maintenance

according to the specified maintenance action.
2. Replace with a new reagent cassette. Do not add or mix
old and new reagent.
3. Replace with new ProCell/CleanCell or PreClean
bottles (e 801/e 602 modules).
4. The water quality must be 1 µS/cm (microsiemens per
cm) or less.
5. Handle reagents according to manufacturer’s
recommendation.
6. Check the completeness of the special wash list (not
applicable to e 801 modules). If necessary, install the
special wash list according to the recommendation of
the manufacturer.
7. Check the application setting in the Cap Open/Close
Mode area on Utility > Application > Analyze (e 602
module only). We recommend using the Open Upon
Pipetting option for all tests in order to guarantee
maximum reagent stability.
High test results

Cause • Concentration of QC material or sample.
• Deterioration of calibrator.
• Deterioration of ProCell or CleanCell or PreClean
(e 801/e 602 modules).
• The reagent, QC material, or calibrator handling was
19 Data alarms
not done as recommended.
Remedy 1. Avoid leaving the sample or QC material in the

container for extended periods.
2. Avoid leaving the calibrator cup open for extended
periods.
3. Replace with new ProCell/CleanCell/PreClean bottles
4. Handle reagents, calibrators, and QC materials
according to manufacturer’s recommendation.
Roche Diagnostics
1226 Data problems without alarm
Low test results

Cause • Concentration of calibrator.
• Reagent was not stored or handled as recommended.
• The test parameters are not set properly.
• Deterioration of ProCell or CleanCell or PreClean
Remedy 1. Use the calibrator immediately after opening the cap of

the calibrator vial.
2. Replace the reagent.
3. Set the concentration of calibrator properly (not for
e 801/e 602 modules).
4. Replace with new ProCell/CleanCell/PreClean bottles
Problems due to the properties of a reagent

Cause • Carryover (upper limit, lower limit)
• Coloring matter adheres to the reaction cell.
Remedy 1. Perform the maintenance action wash reaction parts.

2. Check whether the special wash list is complete. Install
the special wash list according to the manufacturer’s
recommendations.
u Related topics
module (907)
• Defining special wash data (751)
Problems with every test

Cause • Improper preparation or management of calibrator or
19 Data alarms
QC material (upper limit, lower limit).

• Improper management of reagent (lower limit).
Remedy 1. Prepare a new calibrator or QC material.

2. Replace with a new reagent cassette.
3. Set the test parameters properly according to the
setting table given by the reagent manufacturer.
Roche Diagnostics
Problems on all analytical modules

Cause • Air bubbles in the sample or reagent syringe (poor
reproducibility).
• Liquid leakage from sample or reagent syringe (poor
reproducibility).
• Deterioration of ProCell, CleanCell, or PreClean
Remedy 1. Carry out maintenance and inspection.

2. Replace with new ProCell/CleanCell or PreClean
bottles (e 801/e 602 modules).
Problems on both measuring channels on the same module

Cause • Air bubbles in the sipper syringe (poor reproducibility).
• Liquid leakage from sipper syringe (poor
reproducibility).
• The electrode of the measuring cell is contaminated or
deteriorated (upper limit or lower limit).
Remedy 1. Contact your Roche Service representative.

2. Perform the maintenance action liquid flow cleaning
according to the specified procedure.
19 Data alarms
Roche Diagnostics
1228 Rerun test list
Rerun test list

The following table indicates whether a rerun test is
automatically requested by the system when a data alarm
is attached to a test result. The rerun test conditions are
displayed for each module. The automatic rerun column
indicates whether a rerun test is automatically performed
by the system.
I Test is rerun with an increased pipetting volume.
N Test is rerun with the same (normal) pipetting

volume (repeat test).
D Test is rerun with a decreased pipetting volume.
NR No test rerun is performed on this module.
- Not applicable
Data alarm Data alarm (long name) ISE c 701 c 702 c 502 e 801 e 602 Automatic rerun
>Abs ABS over - D D D - - Yes
ADC.E ADC abnormal N N N N - - Yes
Calc.? Calculation not possible N N N N - N Yes
Cal.E (for Calibration result abnormal (for samples) N N N N N N No
samples)
Cal.I Calibration result invalid N N N N N N No
CarOvr Potential carryover - - - - N N Yes
Cell.T Cell temperature - - - - N N Yes
ClcT.E Calculation test error N N N N - - Yes
Clot.E Clot pressure abnormal - - - - N N Yes
CmpT.? Unable to calculate comp. test N N N N - - Yes
(compensation test)
CmpT.E Data error in comp. test (compensation test) N N N N - - Yes
>Curr Current range over - - - - N N Yes
>Cuvet ABS Cell blank abnormal - N N N - - Yes
Det.S Carryover detergent short - N N N - - No
Edited Edited test NR NR NR NR NR NR No
< >ISE ISE range over I(1) - - - - - Yes
19 Data alarms
>I.H Serum index interference hemolysis NR NR NR NR - NR No

>I.HI Serum index interference hemolysis/icteric NR NR NR NR - NR No
>I.I Serum index interference icteric NR NR NR NR - NR No
>I.L Serum index interference lipaemia NR NR NR NR - NR No
>I.LH Serum index interference lipaemia/hemolysis NR NR NR NR - NR No
>I.LHI Serum index interference NR NR NR NR - NR No
lipaemia/hemolysis/icteric
>I.LI Serum index interference lipaemia/icteric NR NR NR NR - NR No
Inc.T Incubator temperature - - - - N N Yes
ISE.E ISE voltage level error N - - - - - Yes
y Rerun test list
Roche Diagnostics
Rerun test list 1229
Data alarm Data alarm (long name) ISE c 701 c 702 c 502 e 801 e 602 Automatic rerun
ISE.N ISE noise error N - - - - - Yes
>Kin Kinetic unstable (Prozone error 2) - D D D - - Yes
>Lin Linearity abnormal - N N N - - Yes
MIXLOW Mixing current low N N N N - - Yes
MIXSTP Stop mixing N N N N - - Yes
na.LHI Serum index measurement not performed NR NR NR NR - NR No
OBS.RM On-board stability limit over on reagent - - NR - - - No
manager
OBS.RR On-board stability limit over on reagent rotor - NR NR NR NR NR No
Over.E Overflow - NR NR NR NR NR No
>Proz Prozone error - D D D - - Yes
>React Reaction limit over - D D D - - Yes
ReagEx Reagent expired date - NR NR NR NR NR No
Reag.F Reagent film or foam detection - - - - N N Yes
Reag.H Reagent hovering - - - - N N Yes
Reag.S Reagent short N N N N N N No
Reag.T Reagent disk temperature - - - - N N Yes
>Rept/<Rept Repeat limit over (upper)/(lower) N N N N N N Due to setting
Samp.? ABS maximum over (non-lin curve) - D D D - - Yes
Samp.B Sample air bubble - - - - N N Yes
Samp.C Sample clot N N N N N N No
Samp.O Sample carryover for modules NR NR NR NR NR NR No
Samp.S Sample short N N N N N N No
<SigL Minimum signal - - - - N N Yes
SLLD.E Sample LLD abnormal - - - - N N Yes
SLLD.N Sample LLD noise - - - - N N Yes
SysR.S System reagent short - - - - - N Yes
SysR.T System reagent temperature - - - - N N Yes
< >Test ISE sample range over N - - - - - No
>Test Technical limit over (upper) N(2) D D D D D Yes
<Test Technical limit over (lower) N(2) I I I NR NR ISE: Yes
c 701/c 702/
c 502: Yes
e 801/e 602: No
WB.S Washing buffer short - - - - N N Yes
WBSS.T Washing buffer SS temperature - - - - N - Yes
19 Data alarms
WB.T Washing buffer temperature - - - - N N Yes

y Rerun test list
(1) Increased pipetting volume for Na+ and Cl- tests. This alarm is effective for urine samples only and is not applicable to K+ tests.
(2) Normal pipetting volume for serum/plasma samples. For urine samples, it depends on the technical limit setting whether a rerun test is requested
with normal pipetting volume or whether this alarm is issued at all.
u Related topics
Roche Diagnostics
1230
19 Data alarms Rerun test list
Roche Diagnostics
1231
Table of contents
Troubleshooting 20
In this chapter 20
General troubleshooting information . . . . . . . . . . . . . . 1233
Overview of troubleshooting areas . . . . . . . . . . . . . 1233
Operator's responsibility. . . . . . . . . . . . . . . . . . . . . . 1233
Contacting your Roche Service representative. . . 1234
Problem with a clinical chemistry test . . . . . . . 1234
Problem with an immunology test . . . . . . . . . . . 1235
Problems with the instrument . . . . . . . . . . . . . . 1235
Powering off a specific module completely . . . 1235
Powering on a specific module . . . . . . . . . . . . . 1237
General troubleshooting of the instrument . . . . . . . . . 1238
Problems with powering on the instrument . . . . . . 1238
General instrument troubleshooting . . . . . . . . . . . . 1238
Mechanical problems . . . . . . . . . . . . . . . . . . . . . 1239
No electric power . . . . . . . . . . . . . . . . . . . . . . . . 1239
Unable to access a software menu . . . . . . . . . . 1240
Non-responding touch screen . . . . . . . . . . . . . . 1240
Illegible touch screen . . . . . . . . . . . . . . . . . . . . . 1241
20 Troubleshooting
Non-descending sample probes to liquid
surface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1241
Selecting samples to compare the reaction
curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1242
Troubleshooting on the ISE module. . . . . . . . . . . . . . . . 1243
Only one ISE unit shows erratic results. . . . . . . . . . 1243
All results are erratic . . . . . . . . . . . . . . . . . . . . . . . . . 1244
Other causes for erratic test results . . . . . . . . . . . . 1245
High or low ISE Internal Standard values . . . . . . . . 1246
High sodium or low chloride test results. . . . . . . . . 1247
Low test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1247
Air bubbles in syringes . . . . . . . . . . . . . . . . . . . . . . . 1248
Roche Diagnostics
1232
Table of contents
Troubleshooting on cobas c modules . . . . . . . . . . . . . . 1249

High test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1249
Low test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1250
Erratic test results . . . . . . . . . . . . . . . . . . . . . . . . . . . 1251
Erratic or biased test results . . . . . . . . . . . . . . . . . . 1253
Problems with a single sample or with QC material 1254
Problems with a single test or one reagent
cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1255
Problems with tests that use more than one
calibration point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1256
Problems with multiple photometric tests or more
than one reagent cassette . . . . . . . . . . . . . . . . . . . . 1256
Problems with all photometric tests . . . . . . . . . . . . 1257
Biased enzyme results. . . . . . . . . . . . . . . . . . . . . . . . 1258
Reagent cassette gripper of the c 702 module
stops during operation . . . . . . . . . . . . . . . . . . . . . . . 1259
Troubleshooting on cobas e modules . . . . . . . . . . . . . . 1260
Problems loading reagents cassettes on the
e 801 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1260
Problem with a loading port due to RFID
reading errors on the e 801 module . . . . . . . . . 1260
Reagent registration stopped on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1262
Problem with the reagent loader on the e 801
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1263
Problem with the reagent cassette handling
on the e 801 module . . . . . . . . . . . . . . . . . . . . . . 1264
Problems with opening/closing of the e 602
module reagent disk cover . . . . . . . . . . . . . . . . . . . . 1266
Problems replacing ProCell/CleanCell bottles . . . 1267
Problems replacing PreClean bottles on the e 602
module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1267
Drift of QC results or test results. . . . . . . . . . . . . . . 1268
Erratic test results . . . . . . . . . . . . . . . . . . . . . . . . . . . 1268
Calibration problems . . . . . . . . . . . . . . . . . . . . . . . . . 1270
Unable to run a calibration . . . . . . . . . . . . . . . . . 1270
20 Troubleshooting
Calibration not released . . . . . . . . . . . . . . . . . . . 1271

Duplicate calibration measurements are out of
limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1271
Monotony criteria not fulfilled in calibration
results on e 602 modules . . . . . . . . . . . . . . . . . . 1271
Problems with missing calibration results. . . . . 1272
Calibration results are out of limits . . . . . . . . . . 1272
Calibration factor is out of limits . . . . . . . . . . . . 1273
QC values are out of limits . . . . . . . . . . . . . . . . . . . . 1274
Problems with intra-test precision . . . . . . . . . . . . . . 1275
Problems with inter-test precision for both
measuring channels. . . . . . . . . . . . . . . . . . . . . . . . . . 1275
Deviation of test results on different modules. . . . 1276
Deviation of method comparison results . . . . . . . . 1276
Roche Diagnostics
General troubleshooting information

This chapter provides general information about
troubleshooting problems on the instrument.
Overview of troubleshooting areas

To identify and isolate problems effectively, you must
understand the theory of operation, operating procedures,
emergency procedures, and test reaction descriptions
covered in this manual. The following areas are covered:
Application problems • Photometric, immunology, or ISE test

• Reagents
• Samples, QC materials, or calibrators
• Operator error
Instrument problems • Electrical/electronic

• Mechanical
• Operator error
Computer problems • Problems during download procedure, incorrect

parameters
• System parameter reading
• Operator error
Facility problems • Heat

• Humidity
• Power supply
• Water supply
• Drain
20 Troubleshooting
Operator's responsibility
• Reagent, calibrator, and QC material preparation and
storage
• Sample preparation
• Instrument mechanical alignments and adjustments
• Computer parameters and general computer
input/output operations
• Basic component replacement
• Basic operator technique, including computer
operation
• Maintenance
Roche Diagnostics
1234 General troubleshooting information
q The basic operator is not responsible for

troubleshooting electrical problems except as covered in
this part of the Operator’s Manual: Do not attempt removal
of printed circuit boards unless instructed to do so by a
When troubleshooting, observe and record the alarms and

isolate the problem to the area denoted by the alarms. In
many cases, you are able to find the problem, correct it
and then resume processing. The remainder of this chapter
provides instructions and guidelines to aid in isolating
problems.
Contacting your Roche Service representative

If you need to contact your Roche Service representative
to troubleshoot a test or instrument problem, be prepared
with the following information:
u The items are divided into the following categories:
Problem with a clinical chemistry test (1234)
Problem with an immunology test (1235)
Problems with the instrument (1235)
Problem with a clinical chemistry test

• Account number/customer ID number
• Instrument serial number
• Module type and serial number
• Software version
• Description of the problem including relevant alarm(s)
and alarm code numbers
• Test(s) affected and other tests on board
20 Troubleshooting
• Special wash programming

• Catalog number, lot numbers, and expiry dates of
reagents
• Catalog number, lot numbers, and expiry dates of
calibrators and QC materials
• Lot number of ISE electrodes
• Calibration absorbance values from the last few
calibrations performed
• QC results from the last few QC measurements
performed
• Patient results (with correlation results, if relevant)
• Reaction monitor report for affected test(s)
Roche Diagnostics
Problem with an immunology test

• Instrument serial number and module serial number
• Software version
• Description of the problem including relevant alarm(s)
and alarm code numbers
• Is the problem specific to the module or measuring
channel
• One or more tests affected and other tests on board
• When problem first occurred
• Special wash programming
• Catalog numbers, lot numbers, and expiry dates of
reagents
• Catalog numbers, lot numbers, and expiry dates of
calibrators and QC materials
• Calibration results from the last few calibrations
performed
• QC results from the last few QC measurements
performed
• Patient results (with correlation results, if relevant)
Problems with the instrument

• Instrument serial number
• Software version and installed language
• Installation date of instrument and software
• Detailed description of the problem including any form
of evidence (e.g., screenshots, photos, or printed data)
- Frequency and circumstances of occurrence
- Alarm(s) and alarm code numbers
- Alarm trace of the date in question
• Other instrument or maintenance-related information
20 Troubleshooting
Powering off a specific module completely

To identify and isolate problems effectively, you can turn
off the power supply for selected modules.
If you turn off the circuit breaker at the rear of a module,

also the power for cooling reagents and auto QC materials
is turned off.
Roche Diagnostics
1236 General troubleshooting information
j m You need supervisor or administrator access rights.

m The complete instrument is in Standby mode.
m Or: The respective module is masked and in Standby
mode.
r To power off a specific module
1 Unload the reagents from the module. Store the

reagents as specified in the Instructions for Use.
2
2 Choose Utility > System Configuration > Module
Settings.
3
3 Choose the desired module.
5
5 CAUTION! Personal injury due to accidentally restarted
instrument.
If the instrument is restarted accidentally by a third
person during the replacement of parts, personal injury
may result.
5 Turn off the circuit breaker at the rear of the module.
u Related topics
• Unloading reagent cassettes from the c 502
20 Troubleshooting
module (380)
Roche Diagnostics
Powering on a specific module

To continue operating on a powered-off module, you must
power on the module properly.
r To power on a specific module
1
1 Switch on the circuit breaker at the rear of the module.
2
2 Choose Utility > System Configuration > Module
Settings.
3
5 Load the reagent cassettes onto the module again.
6
6 On the Overview menu, ensure that the Inc. fields and
the Reac. fields display incubator temperatures of
37 °C ± 0.1 °C before you start measurement.
20 Troubleshooting
u Related topics
Roche Diagnostics
1238 General troubleshooting of the instrument
General troubleshooting of the instrument

This chapter provides information about troubleshooting
procedures for the system as a whole. Procedures for
troubleshooting general instrument problems as well as
problems during power-up are described.
Problems with powering on the instrument

Conditions that can affect instrument power-up are
presented in the table below.
To troubleshoot a problem, determine the category below

that best describes the problem, and follow the
recommended remedy. If all remedies are unsuccessful,
PROBLEM: The instrument does not power up when the operation

power switch (on the front side of the core unit) is pressed.
q The instrument must only be connected to a power

supply source with the specified power cable and by
trained personnel.
Always make sure that the power switch is in the off
position before plugging in the instrument.
Cause or description Remedy

o Instrument is unplugged. Plug instrument power cable into socket.
o Circuit breaker at the rear of the core unit is in OFF position. Switch circuit breaker to the ON position.
o The circuit breaker for one of the modules is switched off. Switch the circuit breaker to the ON position.
o A circuit breaker in your laboratory is in the OFF position. Have your facility electrician check the appropriate circuit
breaker.
o At the core unit, the power outlet to the control unit is Plug the power cable into the core unit. If the instrument still
unplugged. does not power up, contact your Roche Service representative.
20 Troubleshooting
y Troubleshooting at power-up
General instrument troubleshooting

procedures for general instrument problems.
To troubleshoot a problem, determine the category below

that best describes the problem, and follow the
recommended remedy. If all remedies are unsuccessful,
Roche Diagnostics
Mechanical problems
The control unit controls and monitors all mechanical
functions of the instrument. When a mechanical problem
arises within the instrument, it is immediately recognized by
the system. The alarm indicator on the global Alarm button
lights up, alerting you to the problem. Touch Alarm to
display the Alarm window with the specific alarm code,
date and time the alarm occurred and a description of the
alarm. Touch a specific alarm to display the alarm details
and appropriate remedy.
For certain problems affecting the instrument

performance, the system terminates the Operation mode
and enters the S. Stop (Sampling stop) or Stop mode. In the
S. Stop mode, the system allows completion of the
samples in process unaffected by the failure. If the
problem affects all samples in process, the computer
immediately terminates the Operation mode with a Stop or
E.Stop (emergency stop).
q Certain instrument problems may arise that the

instrument does not monitor. If so, no alarm will be issued
to alert the operator. Such problems may include worn
parts, air leaks in the syringe system, reagent
contamination, etc.
When you encounter these types of problems, you must
decide whether to continue to process samples or
terminate the operation, depending on the possibility of
causing damage to the instrument or reporting erroneous
test results.
No electric power
If you are having problems powering the instrument on,
follow this procedure:
20 Troubleshooting
r To troubleshoot problems with the

electrical power
1 Ensure that the power-on button at the core unit is

switched on.
2 Ensure that the circuit breakers at the rear of each

module are switched on.
3 If the power cable is disconnected at either the

instrument or the outlet, firmly connect the power
cable.
Roche Diagnostics
4 Ensure that the power distribution in the laboratory is

working.
5 Ensure that line voltage is adequate.
6 If you are still experiencing problems, contact your

Unable to access a software menu

If you are unable to access another software submenu,
r To troubleshoot problems accessing

another software submenu
1 Power OFF the instrument at the circuit breaker.
2 Check the cabling between the touch screen and the

instrument.
3 Power ON the instrument at the circuit breaker. If you

are still unable to access another submenu, contact
Non-responding touch screen

If you are having problems with the touch screen, follow
this procedure:

touch screen
20 Troubleshooting
1 Is the operation ON/OFF switch on the front of the

touch screen switched OFF?
• If yes, then go to step 2.
• If no, then go to step 3.
2 Switch the operation switch ON.
3 Is the cable between the touch screen and the

instrument disconnected?
4 Firmly connect the cable.
Roche Diagnostics

Illegible touch screen

If the content of the touch screen is difficult to see, follow
this procedure:

touch screen
1 Is the touch screen dirty?

2 Gently wipe the surface with a dry cloth.
3 Is the ambient lighting too bright?

4 Either reduce the brightness of the ambient lighting or

change the direction of the monitor.

Non-descending sample probes to liquid surface

If the sample probes do not descend to the liquid surface,

20 Troubleshooting
descending of the probes
1 Are there air bubbles on the liquid surface?

2 Eliminate the air bubbles in the sample container with a

cotton swab.
3 If the probe tip touched something during descent,

remove the obstacle.
Roche Diagnostics
Selecting samples to compare the reaction curves

With the Overlay window, you can select up to 5 samples or
QC materials of a specific test to compare the reaction
curves. The results show the relationship from one sample
or QC material to another for a given test. This can assist in
troubleshooting potential system or sample problems.
r Comparing reaction curves of up to

5 samples for a specific test
1 Choose Workplace > Data Review > Reaction Monitor

> Overlay.
2 Select a sample to be added to the lower list.
3 Select a symbol in the lower list.
4 Choose the Add button to add this sample to the lower

list.
f The symbol is displayed in the upper list box in the
Assort column.
5 Repeat steps 2 to 4 to select further samples. Up to

5 samples can be selected to overlay.
f The reaction graphs then overlay each other and
display on the Reaction Monitor window.
20 Troubleshooting
Roche Diagnostics
Troubleshooting on the ISE module

procedures specific to the ISE module.
Only one ISE unit shows erratic results
r Only one ISE unit shows erratic

results on one or more samples
1 Check if the wrong sample container was used (for

example, heparin sample tubes).
2 Check for contamination of sample containers.
r Only one ISE unit shows erratic

results that are not repeated
1 Check for small air bubbles in the ISE Reference

Electrolyte, ISE Diluent and or ISE Internal Standard
aspiration tubings.
• If air bubbles are present, choose Utility
> Maintenance and perform the maintenance action
reagent prime (All).
• If air bubbles are still visible, check if reagents were
allowed to reach room temperature before being
used.
2 Check if the signal cable connection of the affected

measuring channel is loose or has a salt bridge.
• If a salt bridge is present, check the reference
20 Troubleshooting
electrode compartment for leaks.
• If only one ISE unit shows erratic results on all
samples, follow the next steps of this procedure.
3 Check for contamination and use of the correct sample

containers.
4 Perform a calibration and QC.

I If the calibration and QC data of the affected ISE
unit show irregularities and/or data alarms, follow
the remedy described in the data alarm list.
Roche Diagnostics
1244 Troubleshooting on the ISE module
All results are erratic
r Problems with erratic ISE results
1 Check reagent volumes in reagent containers.

• If reagent volumes are not sufficient, replenish
reagent.
• Make sure the ISE Reference Electrolyte aspiration
tubing touches the bottom of the bottle.
maintenance action reagent prime on the ISE
module; select All and enter 20 cycles.
2 Check whether the system is leaking.

• Check all tubings and connectors for leaks.
• Tighten loose fittings.
• Check seals of the syringes.
3 Check whether the measuring electrodes are placed

properly.
• If not, place the electrodes in correct position.
4 Check whether the reference electrode is placed

properly.
• If not, place the reference electrode in its proper
position.
20 Troubleshooting
5 If problem recurs, contact your Roche Service

representative.
Roche Diagnostics
Other causes for erratic test results
r Problems with erratic ISE test results
1 Is the ISE Reference Electrolyte aspiration tubing

correctly placed in the bottle?
• If no, check placement of aspiration tubing, prime
reagents and repeat tests.
2 Is there salt buildup on electrodes or syringes or are

there any loose connectors?
• If yes, tighten any loose or leaky connectors, then
clean all salt buildup with wet gauze and repeat
tests.
3 Check tubing of ISE sipper nozzle for kinks or occlusions

and remove them.
4 Perform the maintenance check ISE check (30 cycles).

• If results are not within range, replace reference
electrode.
module; select All and enter 20 cycles. Then,
recalibrate and repeat tests.
I The measurement-to-measurement difference after
the first 10 cycles within the 30 cycle interval
should not be greater than ± 0.2 mV for the Na+, K+,
and Cl- electrodes.
5 Are there air bubbles in the ISE sipper syringe?

• If yes, replace seal in the ISE sipper syringe and
prime the ISE Internal Standard solution.
module.
20 Troubleshooting
6 Verify that microbial growth is not present in the

reagent system. If necessary, clean the ISE flow path.

representative.
u Related topics
operation (843)
Roche Diagnostics
High or low ISE Internal Standard values
r Problems with high/low values of ISE

Internal Standard
1 Is the measured voltage for ISE Internal Standard and

the ISE Internal Standard concentration value higher
than normal?
• If yes, go to step 2.
• If no, go to step 5.
I The measured voltage for ISE Internal Standard
deviated ± 2 mV maximum from the mean value
between the ISE Standard Low and
ISE Standard High. The ideal concentration of ISE
Internal Standard is:
Na+: 130–150 mmol/L
K+: 4.6–5.4 mmol/L
Cl-: 90–110 mmol/L
2 Check that ISE Internal Standard is correctly placed on

the system.
• Replace ISE reagents if necessary.
3 Check that fresh ISE calibrators are used and that they
are placed in the correct positions of the calibrator
rack.
• Replace ISE calibrators if necessary.
4 Check the ISE sipper syringe assembly. Are there leaks?

• If yes, call your Roche Service representative.
5 Perform the maintenance check ISE Check.

• If all values (Na+, K+, and Cl-) are too high or too low,
replace the reference electrode. An ISE.E data
alarm is displayed in the printout adjacent to the
respective measured voltage if the following limits
20 Troubleshooting
are exceeded: K+: -90 mV to -10 mV Na+: -90 mV to

-10 mV Cl-: 80–160 mV
• If only single values (Na, K or Cl) are outside the
range, replace the respective electrode.

representative.
u Related topics
• Changing ISE module reagents (318)
module (862)
• Replacing the reference electrode of the ISE
module (874)
Roche Diagnostics
High sodium or low chloride test results
r Problems with high sodium and low

chloride values
1 Were fresh ISE Standard Low and ISE Standard High

used?
• If no, recalibrate with fresh calibrators and repeat
the test.
2 Prepare fresh ISE Internal Standard and ISE Diluent

reagents.
• Replace old ISE Internal Standard and ISE Diluent
reagents with the fresh reagent.
• Prime the fresh reagent: Choose Utility
reagent prime on the ISE module; select All and
enter 20 cycles.
• Recalibrate 2 times with fresh reagents and
calibrators.
• Repeat the test.

representative.
Low test results
r Problems with low ISE values
1 Were fresh ISE Standard Low and ISE Standard High

used?
• If no, recalibrate with fresh calibrators and repeat
20 Troubleshooting
the test.
2 Were fresh ISE reagents used? If no, prepare fresh ISE

Internal Standard and ISE Diluent:
• Replace old ISE Internal Standard and ISE Diluent
reagents with the fresh reagent.
• Prime the fresh reagent: Choose Utility
reagent prime on the ISE module; select All and
enter 20 cycles.
• Recalibrate 2 times with fresh reagents and
calibrators.
• Repeat the test.
Roche Diagnostics
3 On Calibration > Install, ensure that the correct

compensator values for ISE Standard High (S3)
(ISECOMP) are entered in the Std(3) field.

representative.
Air bubbles in syringes

If you see air bubbles in either the reagent syringes and/or
sample syringe, follow the corresponding procedure:
r To troubleshoot problems with air

bubbles in DIL, IS or REF syringes
1 Choose Utility > Maintenance and select (8) Reagent

Prime from the Maintenance list.
2 Select All from the Prime Item box and enter 20 cycles.
3 If there are still air bubbles in the syringe, repeat this

process for the syringe concerned.
4 If air bubbles remain in the syringe after the second

pipetter prime, contact your Roche Service
representative.

bubbles in the sample syringe
1 Choose Utility > Maintenance and select (6) Air Purge

from the Maintenance list.
20 Troubleshooting
2 Select the ISE module and choose Execute.

process.
4 If air bubbles remain in the syringe after the second air

purge, contact your Roche Service representative.
Roche Diagnostics
Troubleshooting on cobas c modules

procedures specific to the c 701/c 702 and c 502
modules.
High test results

The following may cause high test results on cobas c
modules. Identify the module(s) giving high test results and
r To troubleshoot problems with high

test results

to false results.
1 Incubation bath temperature is incorrect.
• If the incubation bath temperature does not read
37 °C ± 0.1 °C, contact your Roche Service
representative.
2 Poor calibration results.

• Check calibrator preparation.
• Check proper calibration programming and
calibration results. Repeat calibration if necessary.
3 Calibrators were not properly prepared.

20 Troubleshooting
• Check calibrator preparation and calibration
results. Repeat calibration.
4 Evaporation of sample, calibrator, or QC material.

• Repeat analysis with fresh sample, calibrator and/or
QC material.
• If calibrators and QC materials have been loaded on
the racks for more than 2 hours, evaporation of
calibrator may lead to lower results for samples.
5 Reagents were not properly prepared.

• Check reagent preparation and expiry date.
Roche Diagnostics
1250 Troubleshooting on cobas c modules
6 Information is not correct on Calibration > Install.

• Verify the calibration points on Calibration > Install
and compare the displayed data with the
documentation for a specific test.
• Verify the calibration pipetting volume in the
7 Incorrect sampling or dilution of sample.

• Check correct assembly of the sample pipetter.
• Check all fittings and syringes for leaks. If there are
leaks, call your Roche Service representative.
8 Insufficient reagent volume.

• Check reagent pipetting system for leaks.
• Replace reagent cassette and repeat analysis.

Low test results

The following may cause low test results on cobas c
modules. Identify the module(s) giving low test results and
r To troubleshoot problems with low

test results
1 Reagents are expired.

• Prepare new reagents (see Instructions for Use for
the stability of the prepared reagent).
2 Reagents were not properly stored.

20 Troubleshooting
proper storage).
3 Reagents were not properly prepared.

proper preparation instructions).
Roche Diagnostics

to false results.
4 Incubation bath temperature is incorrect.
• If the incubation bath temperature does not read
37 °C ± 0.1 °C, contact your Roche Service
representative.
5 Calibrators were not properly prepared.

• Check calibrator preparation and repeat the
calibration with fresh calibrators.

• Check Calibration > Install and compare the
displayed data with the documentation for a
specific test.
• Verify the calibration pipetting volume in the
7 Ensure that there is sufficient sample in the container.

Check instrument specifications for minimum pipetting
volumes.
8 Check sample for fibrin clotting.
9 Check sample pipetting systems for leaks and air

bubbles.
10 Check sample probe for contaminants and

obstructions.
11 Repeat analysis with appropriate pipetting volume.
12 Check if the reaction cell rinse nozzles are dripping. 20 Troubleshooting

13 Check that ultrasonic mixers are operating properly.

Erratic test results

The following may cause erratic test results on cobas c
modules. Identify the module(s) giving erratic test results
and follow this procedure:
Roche Diagnostics
r To troubleshoot problems with

erratic test results
1 Fibrin clot in 1 sample container or in sample probe (if

low values printed for several samples).
• Check sample for fibrin clot; remove fibrin and
repeat analysis.
• Check sample probe for fibrin clot; clean probe
(perform maintenance action sample probe wash)
and perform an air purge.
• Replace sample probe and sample probe seal.
2 Sample probe does not reach the bottom of the

reaction cell when dispensing sample.
• Perform mechanism check and verify that the probe
reaches the bottom of the reaction cell.
• Check the spring mechanism to make sure the probe
moves up and down freely.
• The sample probe tip may be damaged. Replace the
sample probe.
3 Maintenance was not performed properly or at the

recommended intervals on sample or reagent pipetters
or probes.
• Check the Maintenance submenu and perform any
overdue maintenance functions.
4 If maintenance was recently performed on the sample

probe(s), reagent probe(s), reaction cells, reaction cell
rinse nozzles, or any pipetters:
• Was an air purge performed after maintenance?
• Were all parts correctly assembled?
• Have all tubing and seals been checked for air
leaks?
• Were sample and reagent probe seals replaced?
5 Insufficient pipetting volume.

20 Troubleshooting
• Repeat analysis with sufficient sample.
6 Contaminated incubation bath.

• Check for particles in the incubation bath. If
particles exist, perform the incubator bath cleaning
procedure.
• Check for foaming, perform maintenance action
incubation water exchange.
• Check that the remaining volume of ECO-D on the
module is sufficient. Perform incubation water
exchange.
7 Check for sufficient volumes of reaction cell wash

solutions.
Roche Diagnostics
8 Check the reaction cell rinse unit for contamination and

clean the reaction cell rinse nozzles if necessary.

u Related topics
• Cleaning the pipetter probes of the c 701 and c 702
module (902)
• Cleaning the pipetter probes of the c 502 module (980)
• Cleaning the reaction cell rinse nozzles of the c 701
and c 702 module (905)
• Cleaning the reaction cell rinse nozzles of the c 502
module (982)
Erratic or biased test results

For problems with erratic or biased test results, identify the
cobas c module(s) having problems and follow this
procedure:

erratic or biased test results
1 Verify that the deionized water supply is free from

contamination.
2 Check calibrators used on all modules.

• Calibrators were not properly prepared. Repeat
calibration with fresh calibrator.
20 Troubleshooting
• Check calibrator preparation.

• Verify the calibration points on Calibration > Install
and compare the displayed data with the
documentation for a specific test.
• Check that the calibration pipetting volume in the
application settings is correct.
4 Check sample for fibrin clotting.
Roche Diagnostics
5 Ensure that there is sufficient sample in the container.

Check instrument specifications for minimum pipetting
volumes.
• Repeat analysis with appropriate pipetting volume.


If you see air bubbles in any of the syringes of a cobas c
module, follow this procedure:

bubbles in the syringes
1 Choose Utility > Maintenance and select (6) Air Purge

from the Maintenance list.
3 In the Syringe area, select the syringe to be purged of

air (or all syringes).

process for the syringe concerned.
5 If air bubbles remain in the syringe after the second air

purge, contact your Roche Service representative.
Problems with a single sample or with QC material

For problems with a single sample or QC material, identify
20 Troubleshooting
the cobas c module(s) having problems and follow this

procedure:
Roche Diagnostics
r To troubleshoot problems with a

single sample or QC material
1 Verify that samples and QC materials are placed in the

proper rack and rack positions. If necessary, correct
the placement and repeat the test.
2 Verify the QC values and lot numbers in QC > Install. If

necessary, correct the QC values or lot numbers on the
data manager (QC Parameter) and then download the
modified control data to the control unit.
3 Verify the volume of the sample and/or QC material is

sufficient. Verify the selected container on Workplace
> Test Selection.
4 Verify that the sample integrity is acceptable (fibrin,

lipemia, hemolysis, icterus). If necessary, collect fresh
sample and repeat the test.
5 Verify that the appropriate sample type is selected

(serum/plasma, CSF, urine, supernatant, other) and the
sample is collected appropriately. If necessary, correct
the sample type; check the Instructions for Use for
acceptable sample types. Check the sample collection;
check the Instructions for Use for acceptable sample
collection methods.
6 Verify the collection date and time of the sample are

correct. If necessary, collect fresh sample.
7 Verify that correct test selections were made on

Workplace > Test Selection. If necessary, correct
selections and repeat the test.

20 Troubleshooting
Problems with a single test or one reagent cassette

For repeated or consistent problems with a single
photometric test, identify the module having problems and
Roche Diagnostics
r To troubleshoot problems with a

single test (1 reagent cassette)
1 Verify that reagents have not expired or are not

contaminated or discolored. If necessary, insert a new
reagent cassette.
2 Verify that the correct calibrator code and setpoints

are used. If necessary, correct the calibrator code and
setpoints and repeat the calibration.
3 Verify the special wash programming, if applicable.

Problems with tests that use more than one calibration

point
For problems with photometric tests with more than
1 calibration point, identify the module(s) having problems
and follow this procedure:
r To troubleshoot problems of tests

with more than 1 calibration point
1 Verify that calibrators were properly prepared and

stored. If necessary, prepare new calibrators and
recalibrate.
2 Verify that the assigned calibrators are in the correct

positions. If necessary, place calibrator(s) in correct
position(s), recalibrate and repeat tests. Verify that
required diluents are on board.
20 Troubleshooting

Problems with multiple photometric tests or more than

one reagent cassette
For problems with multiple photometric tests, follow this
procedure:
Roche Diagnostics

multiple photometric tests (more
than 1 reagent cassette)
1 Verify that there are sufficient volumes of special wash

solutions and wash solutions. If necessary, replace the
respective wash solution and rerun the tests needed.
2 Check the reagent probes for barbs, obstructions, or

leaks.
3 Verify that the R1 system is not leaking. Perform an air

purge. If the system is leaking, check connectors in the
R1 pipetter arm and check connectors in the R1
syringe(s).
4 Verify that the incubation bath is free of debris and

foam. If necessary, perform the maintenance action
incubator bath cleaning.
5 Perform a photometer check. Verify that the

photometer check report is within the acceptable limit
(< 14 000). If it is not, replace the photometer lamp.
Perform a cell blank measurement. Calibrate all
photometric tests.
6 Verify the R2/R3 probe(s) is aligned properly. If

necessary, perform a reagent probe check.
7 Verify the R2/R3 probe system(s) is not leaking. Check

connectors in the R2/R3 delivery system(s). Check
syringe connectors. Perform an air purge.

Problems with all photometric tests

20 Troubleshooting
For problems with photometric tests, identify the module(s)

having problems and follow this procedure:
Roche Diagnostics
r To troubleshoot problems with all

photometric tests
1 Verify the sample probe(s) is not blocked or does not

have barbs at the tip. If necessary, clean or replace the
probe(s). Perform an air purge.
2 Verify the sample system(s) is not leaking. If necessary,

check tubing and connectors. Perform an air purge and
check if there are air bubbles in the syringe.
3 Verify that calibrators and QC materials were properly

prepared and stored. If necessary, prepare new
calibrators or QC materials.
4 Check that ultrasonic mixers are operating properly.

Biased enzyme results

For problems with biased enzymes, identify the cobas c
module(s) having problems and follow this procedure:

biased enzymes
1 Verify that the incubation water level is above the

photometer lens.

to false results.
20 Troubleshooting

2 Verify the incubation bath temperature displayed on
the Overview menu is 37 °C ± 0.1 °C. Verify that there is
no incubation bath temperature alarm present.
• If the temperature is out of range, perform an
incubation water exchange, allow the temperature
to stabilize and recheck the incubation bath
temperature.
• If the temperature is still unacceptable, contact
Roche Diagnostics
3 Verify that the sample and reagent syringe seals are in

good condition.
• If no, call your Roche Service representative for
replacement.
4 Verify that the syringe fittings are not loose. If

necessary, correct any loose fittings.
5 Verify that QC materials were prepared using

volumetric pipettes. If not, prepare new QC materials
using a volumetric pipette.
6 Perform a full calibration or blank update.
7 Perform a photometer check. Verify that the

photometer check report is within acceptable limit
(< 14 000). If not, replace the photometer lamp.
Perform a cell blank measurement. Calibrate all
photometric tests.

Reagent cassette gripper of the c 702 module stops

during operation
The home position of the reagent cassette gripper is the
leftmost position of the c 702 module. If the system has
stopped during operation for some reason and the reagent
cassette gripper stopped somewhere other than at the
home position, perform the following procedure.
Otherwise, the module will not resume operation and an
alarm will be issued.
r To move the reagent cassette gripper

20 Troubleshooting
to its home position
1 Verify that the instrument is in Standby mode or the

c 702 module is masked.

5 Restart operation.
Roche Diagnostics
1260 Troubleshooting on cobas e modules
Troubleshooting on cobas e modules

procedures specific to the e 801/e 602 modules.
Problems loading reagents cassettes on the e 801 module

If you are having problems loading reagent cassettes,
follow the corresponding procedure.
In this section
Problem with a loading port due to RFID reading errors on
Reagent registration stopped on the e 801 module (1262)
Problem with the reagent loader on the e 801
module (1263)
Problem with the reagent cassette handling on the e 801
module (1264)
Problem with a loading port due to RFID reading errors on the e 801 module
If you try to load a reagent cassette with a damaged RFID
tag, the instrument issues the RFID reading error alarm.
The status indicator for the corresponding loading port is
flashing yellow.
If the RFID reading error alarm occurs twice for the same
loading port, this loading port is masked.
j m No reagent cassettes are in the reagent loader.

20 Troubleshooting
r To unmask a loading port after RFID

reading errors occurred
1 Prepare a reagent cassette that can be loaded

temporarily for the check. Use a new reagent cassette
from the refrigerator.
I After the check, you can still use the reagent
cassette as a new one. The instrument will not
register the reagent cassette; the onboard stability
time will not start.
Roche Diagnostics
2
2 Choose Utility > Maintenance > Check and choose the
(7) Reagent ID Reader Check option.
• In the e 801 check box, choose the Loader option.
f The instrument resets mechanical components,
which takes approximately 50 seconds.
3 After the reset is finished, fully insert the reagent

cassette into the reagent loader port whose status
indicator is yellow.
4
4 Press the load button.
f The reagent ID reader check starts. The load button
is flashing during the check.
5 When the reagent loader has transported the reagent

cassette back up, remove the reagent cassette. Store
the reagent cassette according to the Instructions for
Use for later use.
6 To lower the reagent loader, press the load button.
7 Make sure that none of the status indicators is flashing;

otherwise check the alarm description and follow the
remedy.
u Related topics
e 801 module (411)
20 Troubleshooting
Roche Diagnostics
Reagent registration stopped on the e 801 module

You try to load a reagent cassette in Standby mode (initial
loading mode). If the instrument detects insufficient
CleanCell M solution during an initial volume check, an
alarm is issued. The reagent registration is stopped.
r To restart reagent registration when

CleanCell M was insufficient
1
1 Replace the CleanCell M bottles.
2
2 Choose Utility > Maintenance > Maintenance and choose
the (8) Reagent Prime option.
the Reagent option.
3
3 To restart reagent registration, press the load button
on the reagent loader.
20 Troubleshooting
u Related topics
• Changing ProCell II M and CleanCell M bottles on the
e 801 module (430)
e 801 module (411)
Roche Diagnostics
Problem with the reagent loader on the e 801 module

If the reagent loader cannot load reagent cassettes
properly, you can perform a reagent loader check.
j m There are no reagent cassettes in the reagent loader

and the loading ports.
r To perform a reagent loader check
1
1 To empty a specific position on the reagent disk for the
check, choose Reagent > Setting.
• Select the reagent cassette on position 48 of the
desired e 801 module.
• Choose the R. Pack Unloading button.
• Choose the Select R. Pack option.
2
2 Unload the reagent cassette:
• Press the load button.
• Take out the reagent cassette from the reagent
loader.
• Store the reagent cassette according to the
Instructions for Use for later use.
• Press the load button again.
3 Prepare up to 5 reagent cassettes that can be loaded

temporarily for a check. Use new reagent cassettes
cassettes as new reagent cassettes. The instrument
will not register the reagent cassettes; the onboard
20 Troubleshooting
stability time will not start.
4
(21) Reagent Loader Check option.
Roche Diagnostics
5
5 After the reset is finished, press the load button.
6 Load the reagent cassettes into the reagent loader.
7
f The reagent loader check starts. The load button is
flashing during the check.

cassettes back up, remove the reagent cassettes.
Store the reagent cassettes according to the

remedy.
u Related topics
e 801 module (411)
Problem with the reagent cassette handling on the e 801 module

20 Troubleshooting
If the reagent cassette handling does not work properly,

you can perform a reagent handling check.
This check includes a loading check, rotor movement

check, reagent shifter check, cap opener check, and
unloading check.
j m There are no reagent cassettes in the reagent loader

and the loading ports.
Roche Diagnostics
r To perform a reagent handling check
1
1 To empty specific positions on the reagent disk for the
check, choose Reagent > Setting.
• Select the reagent cassette on position 1 of the
desired e 801 module.
• Choose the R. Pack Unloading button.
• Choose the Select R. Pack option.
• In the same way, select the reagent cassettes on
the positions 10, 20, 30 and 40 for unloading.
2
2 Unload the selected reagent cassettes:
• Press the load button.
• Take out the reagent cassettes from the reagent
loader.
• Store the reagent cassettes according to the
• Press the load button again.
3 Prepare up to 5 reagent cassettes that can be loaded

temporarily for a check. Use new reagent cassettes
cassettes as new reagent cassettes. The instrument
will not register the reagent cassettes; the onboard
stability time will not start.
4
(22) Reagent Handling Check option.
5
5 After the reset is finished, press the load button.
6 Load the reagent cassettes into the reagent loader.

20 Troubleshooting
Roche Diagnostics
7
f The reagent handling check starts. The load button
is flashing during the check.

cassettes back up, remove the reagent cassettes.
Store the reagent cassettes according to the

remedy.
u Related topics
e 801 module (411)
Problems with opening/closing of the e 602 module

reagent disk cover
If you are having problems opening or closing the reagent
disk cover, follow this procedure:
r To troubleshoot problems opening or

closing the reagent disk cover
1 The reagent disk cover is keyed. Is the reagent disk

cover properly oriented for placement?
20 Troubleshooting

2 Make sure that the reagent disk cover fits into the key
before locking.
3 Is there an obstacle around the cover?

4 Remove the obstacle.

Roche Diagnostics
Problems replacing ProCell/CleanCell bottles

If you are having problems replacing a ProCell or CleanCell
bottle, follow this procedure:
r To troubleshoot problems replacing a

ProCell or CleanCell bottle
1 The ProCell and CleanCell bottles are keyed for proper

placement.
For the e 801 module, the ProCell II M bottle with

readable RFID tag is keyed for proper registration.
Are you placing the bottle in its appropriate position?

• If no, then go to step .2
2 Remove the bottle and check the position before

placing the reagent in its proper place.
For the e 801 module, remove the bottle and replace it

with another bottle in its proper place.
3 Is there an obstacle beneath the system reagent

bottle?
4 Remove the obstacle.

u Related topics
• Changing ProCell II M and CleanCell M bottles on the
20 Troubleshooting
e 801 module (430)
• Changing ProCell M and CleanCell M bottles on the
e 602 module (453)
Problems replacing PreClean bottles on the e 602 module

If you are having problems replacing a PreClean bottle,
Roche Diagnostics
r To troubleshoot problems replacing a

PreClean bottle
1 Ensure PreClean bottles are fully inserted.
2 Ensure that the caps have been slightly opened after

insertion.

u Related topics
• Changing PreClean II M bottles on the e 801
module (433)
• Changing PreClean M bottles on the e 602
module (456)
Drift of QC results or test results

QC material or sample shows drift over a time.
Causes • Evaporation or incorrect storage conditions of reagent

cassettes.
• The reagent cassettes are not at the proper
temperature.
• Recommended calibration interval not used.
• Recommended handling of QC materials and/or
samples not followed (stability and evaporation).
r To troubleshoot problems with drift

of QC materials or samples
1 Did you handle the reagents, calibrators, and/or

QC materials according to the Instructions for Use?
20 Troubleshooting
2 Perform recommended maintenance actions.

Erratic test results

Causes • Foam on sample
• Foam on test reagents
• Foam on QC materials
• Non-recommended sample container used
Roche Diagnostics

erratic test results
1 Did you handle the reagents, samples, and

QC materials according to Instructions for Use?
2 Perform the recommended maintenance actions.


If you see air bubbles in any of the syringes, follow this
procedure:

bubbles in syringes
1 Choose Utility > Maintenance and select (36) System Air

Purge (e602/e801) from the Maintenance list.
• Select both measuring channels and enter 1 cycle.
• If only one syringe is affected, you can also select
the corresponding air purge:
Pipetter air purge
Sipper air purge
Pre-wash sipper air purge
2 Choose Utility > Maintenance and select (37) System

Prime (e602/e801) from the Maintenance list. Select the
desired e 801/e 602 module and enter 1 cycle.

process.
20 Troubleshooting
4 If air bubbles remain in the syringe after twice
performing system air purge (e602/e801) and system
prime (e602/e801), contact your Roche Service
representative.
Roche Diagnostics
Calibration problems
This section provides information about troubleshooting
procedures for problems with calibrations.
To resolve a problem, determine the category below that

best describes the problem and follow the recommended
remedy. If all remedies are unsuccessful, contact your
Unable to run a calibration

Causes • Calibrator vial previously used on the instrument.
• More than 4 calibrations out of one calibrator vial
(calibrators can be pipetted up to 4 times from the
same calibrator vial).
• The reagent cassette or calibrator not on board.
• Calibrator is not installed in the software.
• Calibrator expiry date exceeded.
• Invalid or unreadable calibrator vial barcode, or
calibrator lot-specific data not downloaded.
• Data link not available for combination of reagent
cassette and CalSet.
• Calibrators 1 and 2 not on the same rack or empty
position between calibrators.
• Barcoded calibrator vial placed on a rack with manually
assigned positions.
• A single calibrator set and a multi calibrator set are
placed on the same rack.

calibrations
1 Check position of barcode of calibrator vial and

20 Troubleshooting
reagent cassette or if barcode is damaged.
2 Check if calibrator lot-specific data has been

downloaded.
3 Wipe off the dust on the surface of the barcode reader.
4 Dry the calibrator vial if it is wet.
5 Check calibrator position.

Roche Diagnostics
Calibration not released

u For more information about not released calibration,
see:
Duplicate calibration measurements are out of
limits (1271)
Monotony criteria not fulfilled in calibration results on
e 602 modules (1271)
Problems with missing calibration results (1272)
Calibration results are out of limits (1272)
Calibration factor is out of limits (1273)
Duplicate calibration measurements are out of limits

Causes Foam on calibrator or test reagents.

duplicates out of limits
1 Did you handle the reagents and calibrators according

to the Instructions for Use?
2 Perform a new calibration using a new calibrator vial.

Monotony criteria not fulfilled in calibration results on e 602 modules

Causes Calibrators not transferred to the correct barcoded
calibrator vials. 20 Troubleshooting
r To troubleshoot monotony problems

on e 602 modules

2 Perform a new calibration using a new calibrator vial.

Roche Diagnostics
Problems with missing calibration results

Causes • Empty calibrator.
• Insufficient volume of calibrator or reagents.

missing values

2 Perform a new calibration using a new calibrator vial

and/or new reagent.

Calibration results are out of limits

Values below minimum signal or signal difference between
CalSet 1 and CalSet 2 or maximum signal out of limits
(latest criteria valid for qualitative tests only).
Causes • Possible causes in connection with reagent handling:

- Reagent cassette not at correct temperature.
- Reagent cassette not within allowed stability after
opening.
- Reagent cassette expiry date exceeded.
- Reagent cassette stressed (storage or transport
conditions not as recommended, for example,
temperature, upright position).
- Foam on test reagents.
• Possible causes in connection with calibrator handling:
- Calibrator not at correct temperature.
20 Troubleshooting
- Foam on calibrator.
- Calibrator handling not as recommended.
- Calibrator transferred to the incorrect calibrator
vial. For example, CalSet 1 transferred to CalSet 2
vial.
- Calibrators not within allowed stability after
opening and/or reconstitution.
Roche Diagnostics
r To troubleshoot problems with values

out of limits

2 Perform a new calibration using a new calibrator vial or

reagent cassette.

Calibration factor is out of limits

Only valid for quantitative tests.
Causes • Possible causes in connection with reagent handling:

opening.
- Foam on test reagents.
- Calibrator not at correct temperature.
- Foam on calibrator
- Calibrator handling not as recommended.
- Calibrator transferred to the incorrect calibrator
vial. For example, CalSet 1 transferred to CalSet 2
vial.
- Calibrators not within allowed stability after
opening and/or reconstitution.
20 Troubleshooting

calibration factor out of limits

2 Perform a new calibration using a new calibrator vial or

reagent cassette.
Roche Diagnostics

QC values are out of limits

QC values out of range
Causes • Possible causes in connection with handling of

QC material:
- QC materials not at correct temperature.
- QC material not within allowed stability after
opening or reconstitution.
- Expiry date exceeded.
- Foam on QC materials.
- Handling of QC material not as recommended.
• Possible causes in connection with reagent handling:
opening.
- Foam on test reagents or system reagents.
- Recommended calibration interval not followed.
r To troubleshoot problems with QC

values out of range

20 Troubleshooting
2 Use another calibrator/QC vial or cup.
3 Perform a new calibration using a new calibrator vial

and reagent cassette.

Roche Diagnostics
Problems with intra-test precision

Intra-test precision out of reference range
Causes • Foam on test reagents.

• Reagent cassette and/or sample not at correct
temperature.
• Reagent cassette stressed (storage or transport
r To troubleshoot problems with intra-

test precision
1 Have you handled the reagents, calibrators, and/or


Problems with inter-test precision for both measuring

channels
Inter-test precision out of reference range
Causes • Reagent cassette and/or sample not at correct

temperature.
• Reagent cassette stressed (storage or transport
• Foam on test reagents.
20 Troubleshooting
• Calibration not carefully carried out.
• Recommended calibration interval not followed.
r To troubleshoot problems with inter-

test precision


Roche Diagnostics
Deviation of test results on different modules

Deviation of QC materials and samples when measured
with different modules.
Causes • Recommended handling of test reagents, system

reagents and calibrators, QC materials not followed
(for example, stability, evaporation).
• Calibration not carefully carried out.

module to module variance
1 Did you handle the reagents, system reagents,

calibrators, and/or QC materials according to the
Instructions for Use?

Deviation of method comparison results

Deviation of method comparison when compared with
competitors (internal, external)
Causes • Different standardizations (reference material).

• Different antibodies (for example, HCG on Elecsys).
• Different methods (RIA/ELISA etc.).
• Different measurement units (conversion factor
between units sometimes different from competitor to
competitor).
• Different sample material +/- anticoagulants.
20 Troubleshooting
• Recommended calibration interval not followed.

• Calibration handling not as recommended.
• The number of samples is too small and/or all results
are within a limited range compared to the measuring
range of the test.
• Reagent lot to reagent lot variance.
• System to system variance.
Roche Diagnostics
r To troubleshoot problems


20 Troubleshooting
Roche Diagnostics
1278
20 Troubleshooting Troubleshooting on cobas e modules
Roche Diagnostics
Software description
21 Overview menu ................................................................................. 1281

22 Global buttons and windows ............................................................ 1355
23 Workplace menu ............................................................................... 1489
24 Reagent menu .................................................................................. 1547
25 Calibration menu .............................................................................. 1579
26 QC menu........................................................................................... 1633
27 Utility menu....................................................................................... 1657
Roche Diagnostics
1281
Table of contents
Overview menu 21
The Overview menu is the central menu used for performing

daily operation. From here you can view the status of all
modules, check the amount of reagents available and
perform all steps that are necessary for trouble-free daily
operation.
In this chapter 21
Overview menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1283
Sample Data Clear window . . . . . . . . . . . . . . . . . . . . . . . 1291
Reagent Preparing window . . . . . . . . . . . . . . . . . . . . . . . 1292
Reagent Detergent Volume Reset window . . . . . . . . . . 1294
Inventory Set window. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1295
Calib. and QC Select window . . . . . . . . . . . . . . . . . . . . . 1296
Parameter Download window . . . . . . . . . . . . . . . . . . . . . 1298
Sample Tracking window . . . . . . . . . . . . . . . . . . . . . . . . . 1301
Data Manager window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1305
Communication Setting window. . . . . . . . . . . . . . . . . . . 1306
21 Overview menu
Module window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1307

Cancel Maintenance window . . . . . . . . . . . . . . . . . . . . . 1309
Reagent Overview window (ISE module) . . . . . . . . . . . . 1310
Reagent Overview window (c 701/c 702 module) . . . . 1314
Detail area (c 701/c 702 module) . . . . . . . . . . . . . . . . . 1318
Reagent Manager Overview window (c 702 module) . 1320
Detail window (c 702 module) . . . . . . . . . . . . . . . . . . . . 1324
Take Out window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1326
Reagent Pack Unloading Area window (c 702 module) 1327
Reagent Overview window (c 502 module) . . . . . . . . . 1329
Roche Diagnostics
1282
Table of contents
Detail area (c 502 module) . . . . . . . . . . . . . . . . . . . . . . . 1333

Reagent Overview window (e 801 module) . . . . . . . . . 1335
Detail area (e 801 module) . . . . . . . . . . . . . . . . . . . . . . . 1340
Temperature window (e 801 module) . . . . . . . . . . . . . . 1343
Reagent Overview window (e 602 module) . . . . . . . . . 1345
Detail area (e 602 module) . . . . . . . . . . . . . . . . . . . . . . . 1350
Temperature window (e 602 module) . . . . . . . . . . . . . . 1353
21 Overview menu
Roche Diagnostics
Overview menu 1283
Overview menu
f Overview
f Press F12
This menu starts automatically after log-on.
The Overview menu has a central role within the graphical

user interface. From here the user has an overview of the
whole system at any given time. It displays the status of
each completed sample, and the modules can be prepared
for daily routine operation.
Work Flow Guide area
The Work Flow Guide area guides the user through the daily
routine. This area consists of 6 buttons, whose colors vary
depending on their status. By choosing these buttons,
menus and windows are displayed that enable the user to
take actions appropriate to the situation.
21 Overview menu
w Work Flow Guide area
The Work Flow Guide area uses a color scheme to display

the status of the system. The color scheme is different
when preventive action is activated (the Preventive Action
check box is selected). A table describes the meaning of
the color scheme for each button of the Work Flow Guide.
u Preparing the instrument for operation (285)
Colors in the Work Flow Guide (1285).
Roche Diagnostics
1284 Overview menu
Preventive Action Preventive action informs the user in advance what is

required for the daily routine. For example, which reagents
should be replenished and which calibrations will expire
during the day due to expiration of a test-specific timer.
When Preventive Action is activated, the buttons

concerned on the Overview menu turn purple based on
reagent status. The values for preventive action are
defined in Reagent Level window. The remaining time for
calibration is defined on the Calibration > Status submenu.
Daily Maintenance Use the Daily Maintenance button to execute maintenance

actions or maintenance pipe functions. Choosing this
button displays the Utility > Maintenance submenu.
u See Maintenance submenu (1744).
Sample Data Clear The Sample Data Clear button can be yellow or red. It turns
yellow when the hard disk is nearly full and red when it is
full (12 000 samples). When the Sample Data Clear button
is yellow, it is recommended that the operator deletes the
results. When it is red, the operator must delete all results
from the hard disk otherwise no additional samples can be
processed.
u See Sample Data Clear window (1291).
Reagent Preparing Choose this button to display the Reagent Preparing

window. It turns the color depending on the number of
tests remaining for a reagent and the alarm level for the
reagent.
u See Reagent Preparing window (1292).
Calib. and QC Select This button is yellow if a calibration or QC measurement

needs to be performed. Choose this button to display the
Calib. and QC Select window. Use this window to select the
type of calibration and QC you wish to perform and to print
Calibration and QC Load Lists.
u See Calib. and QC Select window (1296).
21 Overview menu
Parameter Download Choose this button to display the Parameter Download

window.
Yellow indicates that updated or new information is

available for download.
Red indicates that important information is required by the

instrument. Maybe a reagent cassette, calibrator, or QC
was loaded onto the instrument, which has not been
installed before. New information for applications,
calibrators, controls, or special washes must be
downloaded.
u See Parameter Download window (1298).
Roche Diagnostics
Overview menu 1285
Sample Tracking Choose this button to display the Sample Tracking window.
This window displays the status of the racks and sample
tubes currently in the rack unloading area. It provides an
overview of the samples in the rack unloading area.
u See Sample Tracking window (1301).
Colors in the Work Flow Guide
w Work Flow Guide area
Button in Work Flow Guide area Color Meaning

A maintenance item has expired.
A maintenance item has exceeded the warning level.
The number of samples or the number of results has exceeded the

specified limit. No additional samples can be processed until hard disk is
cleared.
The database is nearly full. The number of samples or the number of
results has exceeded the warning level.
Reagent for at least one test or detergent required for the test is not on
board (mandatory) or is empty.
The number of tests remaining for a reagent is less than the yellow
alarm level.
The number of tests remaining for a diluent, test reagent or detergent
volume is less than the purple alarm level (daily requirement) - only
applicable when Preventive Action check box is selected.
The system has recommended a calibration or quality control.
An unknown cassette, calibrator or control was loaded and read by

barcode reader or RFID reader. In order to run that parameter you need
21 Overview menu
to download the according file.
Updated or new information is available for an already downloaded
parameter, for example calibrator values.
No color scheme available.
y Color scheme Work Flow Guide area
Roche Diagnostics
1286 Overview menu
Module Overview area
The Module Overview area provides a view of the current

status of the modules and components (for example, data
manager, control unit, ISE, c 701/c 702, e 801, rack
loading/unloading area) of the system. Each module or
component is represented by a button.
The status of each module is displayed above or next to

the corresponding module or component button.
Additionally the Module Overview area uses a color scheme

to display the status of the system. The color scheme is
different when preventive action is activated (the
Preventive Action check box is selected).
u For more information, see:
Module and component buttons (1288)
Symbol buttons (1289)
Temperature indicator fields (1290).
Colors in the Module Overview area (1287)
Data Manager
This field displays the status of the data manager

connection (Online or Offline) or the alarm level.
For users with Administrator access, the button Data
Manager is available. Choose this button to display more
detailed information about the communication status.
u See Data Manager window (1305).
Control Unit
This field displays the status of the control unit (Standby or

Operation) or the alarm level.
CLAS connect.
If the system is connected to a CLAS (clinical laboratory

21 Overview menu
automation system), this field displays the status of the

connection.
Roche Diagnostics
Overview menu 1287
Colors in the Module Overview area
w Module Overview area of the Overview menu
Button in Module Overview Color Meaning

Communication error or the data manager itself is in an error status
above caution level (S.Stop, Stop, or E.Stop).
Communication error or the data manager itself is in alarm status of
caution level.
Communication online
Communication offline
An instrument alarm above caution level (S.Stop, Stop, or E.Stop).
An instrument alarm with caution level.
Indicates Standby mode.
Indicates a status other than Standby (e.g., Operation or Maintenance).
Connection to CLAS (clinical laboratory automation system) or the

CLAS itself is in an error status above caution level.
Connection to CLAS or the CLAS itself is in an error status of caution
level.
CLAS connection online
CLAS connection offline (e.g., disabled in Start window)
Indicates the module is powered off. 21 Overview menu
y Color scheme Module Overview area
Roche Diagnostics
1288 Overview menu
Button in Module Overview Color Meaning

An instrument alarm above caution level.
An instrument alarm with caution level.
Indicates the module is powered off.
A reagent is empty and there is no second reagent cassette on this

particular module. A mandatory reagent does not exist in the module.
The number of tests remaining for a reagent is less than the yellow
alarm level.
The number of tests remaining for a diluent, test reagent or detergent
volume is less than the purple alarm level (daily requirement) - only
applicable when Preventive Action check box is checked.
No color scheme available.
y Color scheme Module Overview area
Module and component buttons
These buttons display the color corresponding to the

highest priority alarm of the module or component. Use
these buttons to display the Module window for the module
or component currently selected. Use the Module window
to open either the Alarm window or the Cancel Maintenance
window. In the Module window of a module sample buffer
further buttons for Backup Operation are available.
The alarms correspond to the module or component

currently selected.
21 Overview menu
Cancel Maintenance is used to force some maintenance

items running on the currently selected module to stop
after confirmation.
q Some maintenance items cannot be stopped once

they have begun.
Roche Diagnostics
Overview menu 1289
Backup Operation is used if the rack loading/unloading

area or the transportation line can not convey any
samples. This mode enables sample measurement on
modules to continue.
Module window (1307)
Alarm window (1366)
Cancel Maintenance window (1309)
Operating the instrument in backup operating
mode (644)
Symbol buttons
These buttons display different colors depending on the

status of the module or component. If more than one color
applies, the color with the highest priority is displayed.
Choose a button of a module to display the corresponding
Reagent Overview window or choose the button of the rack
loading/unloading area to display the Sample Tracking
window.
Symbol buttons Module Description

Core unit Choose this button to display the Sample Tracking window. This
window displays the status of the racks and sample tubes
currently in the rack unloading area. It provides an overview of
the samples in the unloading area and also allows you to search
for any sample on the instrument as soon as it is registered by
the instrument.
u See Sample Tracking window (1301).
ISE Choose this button to display the Reagent Overview window.
This window displays an overview of the ISE reagents loaded on
the module.
u See Reagent Overview window (ISE module) (1310).
c 701/c 702 Choose this button to display the Reagent Overview window.
This window displays an overview of the reagents loaded on the
module currently selected.
u See Reagent Overview window (c 701/c 702
module) (1314).
c 502/e 801/ Choose this button to display the Reagent Overview window.
21 Overview menu
e 602 This window displays an overview of the reagents loaded on the

module currently selected.
u See Reagent Overview window (c 502 module) (1329)
Reagent Overview window (e 801 module) (1335)
Reagent Overview window (e 602 module) (1345).
y Description of symbol buttons
Roche Diagnostics
1290 Overview menu
Symbol buttons Module Description

c 702 Choose this button to display the Reagent Manager Overview
window. This window displays the reagent cassettes on the
buffer rotor in the reagent manager of the selected c 702
module.
u See Reagent Manager Overview window (c 702
module) (1320).
c 702 Choose this button to display the Reagent Pack Unloading Area
window. This window displays the reagent cassettes on the
unloading tray of the selected c 702 module.
u See Reagent Pack Unloading Area window (c 702
module) (1327).
e 801/e 602 Choose this button to display the Temperature window. This
window displays actual temperatures in the module currently
selected.
u See Temperature window (e 801 module) (1343)
Temperature window (e 602 module) (1353).
y Description of symbol buttons
Temperature indicator fields
These fields display the temperatures of the module

components.
Module Abbreviation Temperature inside

MSB of c 702 MSB Cooling unit for auto QCs
RMr Buffer rotor in the reagent manager
MSB (other modules) - Cooling unit for auto QCs
c 701/c 702 Reac. Reaction disk (incubation bath)
Disk A/B Reagent disk A/B
c 502 Reac. Reaction disk (incubation bath)
e 801/e 602 Inc. Incubator
Ch. 1/2 Measuring channel 1/2
ISE support box Inc. Incubator
y Abbreviations of temperature indicators
21 Overview menu
Roche Diagnostics
Sample Data Clear window 1291
Sample Data Clear window

f Overview > Sample Data Clear
Use the Sample Data Clear button to delete the sample

results. If Sample Data Clear is executed, all records of the
samples are deleted. Less sample data on the hard disk
allows faster access to the data. Backing up on a periodic
basis is recommended.
q It is strongly recommended that a Sample Data Clear

is performed daily.
u See Archiving test results (611).
Clear Select this option and choose OK to clear the hard disk
without saving any data after confirmation.
Backup and Clear Select this option and choose OK to back up the data
stored on the hard disk before it is cleared. The Backup
Data window is displayed.
u See Backup Data window (1520).
21 Overview menu
Roche Diagnostics
1292 Reagent Preparing window
Reagent Preparing window

f Overview > Reagent Preparing
w Reagent Preparing window
Use this window to print a Reagent Load/Unload List and to

open the Reagent Detergent Volume Reset window,
Reagent Prime window, Manual Registration window, or
Development Channel window.
q The buttons available on this window depend on the

module configuration.
Reagent Load Unload List Use this button to provide a list of reagents that need to be
loaded on to the modules in order to carry out the daily
routine. Use this button to print the Reagent Load/Unload
List.
If the Including Reagent Manager check box (c 702 only) is

selected, the reagent cassettes on the buffer rotor are
taken into account when generating the Reagent
Load/Unload List.
u See Printing a load list and preparing the
21 Overview menu
reagents (288)
Reagent Detergent Volume Reset (ISE and Use this button to display the Reagent Detergent Volume
photometric modules) Reset window. Use this window to reset the volumes for
detergents and system reagents.
u See Reagent Detergent Volume Reset window (1294)
Reagent Prime (ISE, e 801, e 602 modules) Use this button to display the Reagent Prime window. Use
this window to perform a reagent prime.
u See Reagent Prime window (1560).
Roche Diagnostics
Reagent Preparing window 1293
Inventory Setting (e 602 module) Use this button to display the Inventory Set window. Use
this window to enter the ProCell M lot numbers.
u See Inventory Set window (1578).
Manual Registration (c 701 module) Use this button to display the Manual Registration window.
Use this window to manually register reagents for
Development Channel applications.
u See Manual Registration (C Module) window (1563).
Development Channel (c 702 or c 502 module) Use this button to display the corresponding Development
Channel window. Use this window to assign a
cobas c pack MULTI to an already installed development
channel application (open channel). This must be done
before loading the corresponding cobas c pack MULTI.
u See Development Channel window (1570).
21 Overview menu
Roche Diagnostics
1294 Reagent Detergent Volume Reset window
Reagent Detergent Volume Reset window

f Overview > Reagent Preparing > Reagent Detergent
Volume Reset
w Reagent Detergent Volume Reset window
Use this window to reset the reagent volume counters on

multiple modules at the same time.
List of detergents and reagents Select the check boxes of the bottles that have been
replaced and choose Reset.
21 Overview menu
Roche Diagnostics
Inventory Set window 1295
Inventory Set window

f Overview > Reagent Preparing > Inventory Setting
w Inventory Set window
Use this window to specify the lot numbers for ProCell M

bottles loaded on an e 602 module.
Module Use this list to select the e 602 module to specify the
ProCell lot numbers for.
ProCell Position1/2 This area contains 2 text boxes, ProCell Position 1, for the
ProCell lot number of position 1, and ProCell Position 2, for
the ProCell lot number of position 2.
21 Overview menu
Roche Diagnostics
1296 Calib. and QC Select window
Calib. and QC Select window

f Overview > Calib. and QC Select
w Calib. and QC Select window
Use this window to select calibrations and quality control

to be performed.
The Calib. and QC Select button on the Overview menu

turns yellow indicating a warning has been issued which
can be due to the following:
• The system has recommended a calibration or QC
measurement
• A calibration or QC measurement has failed the
validation criteria
The load lists for calibrators, controls or both can also be

printed from this window.
Calibration (465)
Calibration area
When a calibration is required, use this area to select

calibrations to be performed.
Start up Choose this button to select all tests predefined as a start-

21 Overview menu
up calibration in the Calibration > Status > Start Up Setting

window.
Recommended Choose this button to select the test(s) recommended for

calibration by the system.
Roche Diagnostics
Calib. and QC Select window 1297
This button turns yellow due to the following reasons:

• A test needs to be calibrated and is recommended by
the system (e.g., in case of a new lot number).
• A new reagent pack that does not have a valid
calibration. Therefore, a changeover calibration is
recommended by the system.
• A calibration of a reagent pack fails the calibration
criteria and a new calibration is recommended.
• A lot calibration or reagent pack calibration has expired
and a timeout calibration is recommended.
• If the remaining time is less than the time made for the
preventive action, the reagent pack is then
recommended to be calibrated (Calib. Now).
Load List Print After selecting the calibration to process, load lists can be
used as an aid when loading the required calibrators into
the rack loading area. Choose this button to print a load list
for calibrators recommended by the system.
u See Calibrator Load List (1400).
QC area
When a control is required, use this area to select the

method of control to be performed.
Routine QC Routine QC performs controls for all activated tests of all

installed controls. Choose this button to perform the
routine QC.
Stand By Bottle QC Stand By Bottle QC performs controls for all standby

reagents selected on the Stand By Bottle QC window.
u See Stand By Bottle QC window (1638)
Recommended This button turns yellow, if the time of a control interval

21 Overview menu
from one test has been exceeded. Choose this button to

perform the timeout QC. Timeout QC performs controls for
all tests whose control interval has been exceeded
(defined on the Utility > Application > Range).
Configuring range parameters (737)
Load List Print After selecting the QC to process, load lists can be used as
an aid when loading the required controls into the rack
loading area. Choose this button to print a load list for
controls recommended by the system.
u See QC Load List (1418).
Roche Diagnostics
1298 Parameter Download window
Parameter Download window

f Overview > Parameter Download
w Parameter Download window
The Parameter Download button turns yellow or red to

indicate that there are parameters available for download
from the data manager:
• Yellow: New information is available for download (e.g.,
an update of an application). It is recommended to
download the respective file.
• Red: Important information is required by the
instrument. Maybe a reagent cassette, calibrator, or
QC was loaded onto the instrument, which has not been
installed before.
Choose Parameter Download when the button is yellow or

red to open the Parameter Download window.
Select the tab containing the requested information.

21 Overview menu
u Downloading parameters from the data manager (290)
Application tab
Use the Application tab to download application

parameters.
u Work Flow Guide area (1283)
Info The Info column is left blank for application parameters

which are available for download. An asterisk (*) in this
column indicates that this parameter is missing on the
instrument. The corresponding reagent is on board, so this
download is required.
Roche Diagnostics
Parameter Download window 1299
Module This column displays the module type which requires the
parameter.
Application This column displays the name of the application.
App. Code This column displays the code of the application.
R.Pack ID This column displays the reagent cassette ID.
Calibrator tab
Use the Calibrator tab to download calibrator parameters.
Info The Info column is left blank for calibrator parameters

column indicates that this parameter is missing on the
instrument. The corresponding calibrator is on board, so
this download is required.
Calibrator This column displays the name of the calibrator.
Lot ID This column displays the lot number of the calibrator.
Control tab
Use the Control tab to download control parameters.
Info The Info column is left blank for control parameters which
are available for download. An asterisk (*) in this column
indicates that this parameter is missing on the instrument.
The corresponding control is on board, so this download is
required.
Control This column displays the name of the control.
Lot ID This column displays the lot number of the control. 21 Overview menu
Special Wash tab
Use the Special Wash tab to download special wash

settings.
Info The Info column is left blank for special wash settings
column indicates that this setting is missing on the
instrument.
Special Wash Type This column displays the name of the special wash type
(reagent probe wash, cell wash, sample probe wash).
Module Type This column displays the module type.
Roche Diagnostics
1300 Parameter Download window
Buttons
Download Choose this button to download the selected item from the
data manager.
Delete Choose this button to delete the selected item from the
Parameter Download window.
21 Overview menu
Roche Diagnostics
Sample Tracking window

f Overview > Sample Tracking
f Overview > Symbol button
Select the button for rack loading/unloading area.
w Sample Tracking window
The Sample Tracking window provides an overview of the

samples in the unloading area. The search function allows
you to search for samples which are already in the rack
unloading area.
q The location of a sample is indicated only as long as

the sample tray has not been removed from the unloading
area.
u For more information, see Tracking samples (575).

21 Overview menu
Rack Monitor area
This area displays information on each sample in the

sample rack (1 to 30) in the specified tray of the unloading
area.
The first column, 1–15, corresponds to the order of the

racks in the tray.
The second column displays the color of the rack and the
rack number, for example, S0001. The first character can
be any of the following:
Roche Diagnostics
1302 Sample Tracking window
No character Normal/routine (gray rack)
S STAT/Emergency (red rack)
R Rerun (pink rack)
Q Quality Control (white rack)
C Calibrator (black rack)
W Wash rack (green rack)
? Rack not processed due to a rack ID read

error.
The third column displays the positions 5 to 1 for each

rack. The symbol shows the status of the results for each
sample (position 5 to 1) in each rack. A legend of symbols
and colors is displayed in the Position Status area on the
top of the Sample Tracking window.
Position Status area
The Position Status area displays a legend that defines the

symbols and colors used in the Sample Tracking window. If
a symbol is marked with a check mark, it can be displayed in
the Rack Monitor area. If a symbol is not selected, it is not
displayed in the Rack Monitor area.
The following explains the Position Status legend:
Failed
Measurement of this sample is completed and one or
more results have a data alarm.
Or: A test could not be processed (e.g., due to an empty
reagent or any other type of masking).
Barcode Error
The barcode could not be read and there is no sample
assignment for the rack position.
21 Overview menu
Sample Error
Sampling could not be performed for this sample due to
one of the following reasons:
o Sample volume is too low
o Sample clot
o Air bubbles
If the alarm sample short, sample clot, or sample air
bubble occurs, all subsequently ordered tests for this
particular sample are canceled. Test remains requested.
Empty
The sample position in the rack is empty, or a sample
could not be detected.
Roche Diagnostics
Cup Present
A cup is present but no request has been made.
Completed
The measurement is completed; test results are available
without any data alarm.
Processing
The sample is being processed.
Rack Information area
This area displays detailed information about the sample

results of the rack currently selected in the Rack Monitor
area. The column for positions 1 to 5 of the currently
selected rack in the Rack Monitor area is highlighted in
blue.
w Rack Information area
Pos. This column displays the position (1 to 5) of the sample in

the rack.
Seq. No. This column displays the sequence number that identifies
the sample.
S. Type This field displays the sample type of the sample selected
from the rack.
S. ID This column displays the ID number of the sample.

21 Overview menu
Comment This column displays comments for the sample entered on
the Sample Information window.
u See Sample Information window (1499).
Status This column displays the status of the results for each
sample. A legend of symbols and colors is displayed in the
Position Status area on the top of the Sample Tracking
window.
Data Review Use this button to display the Workplace > Data Review
submenu to view the result from the selected sample. Use
this submenu to perform tasks related to reviewing and
editing routine and STAT results. Control results can also
be viewed from the Workplace > Data Review submenu.
Roche Diagnostics
1304 Sample Tracking window
q Control and calibrator information is not displayed on

the Sample Tracking window. But controls are displayed on
the Data Review submenu.
u See Data Review submenu (1504).
Sample Search area
w Sample Search area (barcode mode)
Use this area to search the database using specified

criteria for information on a specific sample.
The Sample Search area provides 2 options:

• STAT: Use this option to search the database for
specific STAT samples.
• Routine: Use this option to search the database for
specific routine samples.
S. Type Use this list box to specify the sample type to be used in
the search criteria. Choose the list box and select the
sample type (for example, Ser/Pl, Urine, CSF).
Seq. No. (non-barcode mode) Select this check box to enable the adjacent text box in
which to enter a sequence number as a search criterion.
S. ID (barcode mode) Select this check box to enable the adjacent text box in
which to enter a sample ID number as a search criterion.
21 Overview menu
Rack No. Select this check box to enable the adjacent text box in
which to enter a rack number as a search criterion.
Search Choose this button to search the database for information

on a sample with the specified search criteria.
Roche Diagnostics
Data Manager window 1305
Data Manager window

f Overview > Data Manager
w Data Manager window
This window displays the status of the communication to

the data manager. The colored fields indicate which
communication channels are currently online.
q If one of the fields in the Data Manager window is gray

(Wait) or black (Offline), check the network connections
and the settings on the Communication Setting window, or
contact your technical support.
u Further information for host communication specialists

is available in the Host Interface Manual.
HL7 Communication This area indicates the status of the communication

between the data manager and the control unit. The
different fields indicate different communication channels.
The abbreviation HL7 stands for Health Level 7, a standard
protocol used for communication between healthcare
applications.
21 Overview menu
Control Communication This area indicates the general status of the

communication between the data manager and the control
unit.
Communication Setting Choose this button to enable or disable the communication

between the data manager and the control unit.
u See Communication Setting window (1306).
Roche Diagnostics
1306 Communication Setting window
Communication Setting window

f Overview > Data Manager > Communication Setting
w Communication Setting window
This window allows to temporarily disable the

communication to the data manager.
HL7 Communication Use this option to temporarily disable the communication

channels between the data manager and the control unit.
The abbreviation HL7 stands for Health Level 7, a widely-
used standard protocol used for communication between
healthcare applications.
Control Communication Use this option to temporarily disable the general

communication between the data manager and the control
unit.
21 Overview menu
Roche Diagnostics
Module window 1307
Module window
f Overview > Module or Component button
w Module window
Use this window to open either the Alarm window or the

Cancel Maintenance window for the module or component
currently selected or to activate the Backup Operation
mode.
Module This field displays the selected module or component.
Alarm Use this button to display the Alarm window. The Alarm
window is sorted by module or component currently
selected.
u See Alarm window (1366).
Cancel Maintenance Use this button to display the Cancel Maintenance window.
Cancel maintenance is used to force some maintenance
items running on the currently selected module to stop
after confirmation.

they have begun.
u See Cancel Maintenance window (1309).
Backup Operation Use this button to activate the Backup Operation mode.
This mode enables sample measurement on modules to
21 Overview menu
continue, if the rack loading/unloading area or the

transportation line can not convey any samples.
q The Backup Operation mode is unavailable for

calibrators and controls.
u For more information, see Operating the instrument in

backup operating mode (644).
Backup Analyze Use this button to start the processing in Backup

Operation.
u For more information, see Measuring samples in backup
operating mode (646).
Roche Diagnostics
1308 Module window
Backup Collect Use this button to unload racks from the backup operation
port.
21 Overview menu
Roche Diagnostics
Cancel Maintenance window 1309
Cancel Maintenance window

f Overview > Module or Component > Cancel Maintenance
w Cancel Maintenance window
Use this window to cancel a selected maintenance function

performed on the module selected. Confirm with OK to
stop the action.

they have begun.
u For more information, see: Terminating software-

controlled maintenance (779).
Module This field displays the selected module for example ISE,
C7-1, or MSB2.
21 Overview menu
Roche Diagnostics
1310 Reagent Overview window (ISE module)
Reagent Overview window (ISE module)

Select button for reagent overview on ISE module.
w Reagent Overview window (ISE module)
Use this window to view the status of the ISE reagents

loaded on the module selected in the Module Overview
area on the Overview menu.
Abbreviation Unit Description

IS mL ISE Internal Standard
DIL mL ISE Diluent
REF mL ISE Reference Electrolyte (KCl)
EcoTergent mL ECO-D for incubation bath(1)
SmpCln1 mL Sample Cleaner 1 (basic wash)
SmpCln2 mL Sample Cleaner 2 (acid wash)
y ISE reagent types
21 Overview menu
During installation of the system, reagent level checks for

daily consumption (purple alarm) are defined for all
reagents.
If a reagent is required, this is indicated by the Reagent

Preparing button on the Overview menu turning yellow, red
or purple.
u For information, see:
Reagent Level window (1729)
Reagents of the ISE module (316)
Roche Diagnostics
Contents area
The Contents area explains the colors of the boxes below

each bar chart in the Reagent area and the Inventory area.
• R. P.: Remaining reagent volume (first colored box)

• Cal.: Calibration status (second colored box)
• QC: QC status (third colored box)
R. P. (first colored box) The colors of the R. P. box have the following meaning:
Active
Bottle currently in use.
Preparation
Remaining volume in this bottle is below purple alarm
level (Utility > System > Reagent Level).
New reagent should be prepared.
Warning
Remaining volume in this bottle is below yellow alarm
level (Utility > System > Reagent Level).
Caution
There is no more reagent available.
Cal. (second colored box) The colors of the Cal. box have the following meaning:
Valid
A valid calibration is available.
Requested
The reagent is requested or recommended for
calibration.
Failed
Calibration of the reagent has failed or has a changeover
21 Overview menu
request.
QC (third colored box) The colors of the QC box have the following meaning:
Valid
QC result is within the rules defined on the data manager.
Requested
Requested or recommended for QC measurement.
Roche Diagnostics
1312 Reagent Overview window (ISE module)
Failed
QC result is outside the rules defined on the data
manager.
N.A.
Not applicable.
Reagent area
The Reagent area displays the remaining volume by using

bar charts. The first colored box below each bar chart
indicates the remaining volume of the ISE reagent. The two
lower color-coded boxes provide additional information on
the statuses of calibration and QC.
Reset Use these buttons to reset the remaining volume of the

corresponding reagent or detergent.
Inventory area
The Inventory area displays the remaining amount of the

sample probe cleaners: SmpCln1 (basic wash), SmpCln2
(acid wash) and ECO-D.
21 Overview menu
Volume OK
Volume < purple alarm level
Roche Diagnostics
Volume < yellow alarm level
Container empty

Button
Reagent Prime Use this button to display the Reagent Prime window. Use
this window to perform a reagent prime.
21 Overview menu
Roche Diagnostics
1314 Reagent Overview window (c 701/c 702 module)
Reagent Overview window (c 701/c 702

module)
Select button for reagent overview on c 701/c 702
module.
w Reagent Overview window (c 701/c 702 module)
Use this window to view the status of the reagents loaded

on the module selected in the Module Overview area of the
Overview menu.

reagents.

21 Overview menu
or purple.
u For information, see:
Reagents of the c 701 module (326)
Contents area
The Contents area at the top of the window explains the

colors represented in the segments of the graphic in the
Reagent area.
Roche Diagnostics
Reagent Overview window (c 701/c 702 module) 1315
• R. P.: Reagent cassette status (inner segment)

• Cal.: Calibration status (middle segment)
• QC: QC status (outer segment)
R. P. (inner segment) The colors of the R. P. segment have the following

meaning:
Active
Reagent cassette currently in use for this test.
Preparation
Remaining tests in this reagent cassette are below the
purple alarm level (Utility > System > Reagent Level).
New reagent cassette should be prepared.
Warning
yellow alarm level (Utility > System > Reagent Level).
Caution
There is no more reagent available for this assay on this
module.
Stand-by
This is a standby reagent cassette.
Cal. (middle segment) The colors of the Cal. segment have the following meaning:
Valid
Requested
calibration.
Failed
Calibration of the reagent has failed.
21 Overview menu
QC (outer segment) The colors of the QC segment have the following meaning:
Valid
Roche Diagnostics
1316 Reagent Overview window (c 701/c 702 module)
Requested
The reagent is requested or recommended for QC
measurement.
Failed
manager.
N.A.
Not applicable.
Colors for all 3 segments The following colors are shown in all three segments:
Zero Tests (Used Up)

The reagent cassette has been used up and is empty.
Reagent is still available in another reagent cassette on
this module.
Free Pos.
There is no reagent cassette in this position.
Invalid
The reagent has exceeded its expiry date (shelf life) or
the onboard stability time has been exceeded.
Reagent area
Use this area to view the status of the reagent cassettes

loaded on the two reagent disks. This area comprises a
graphic representing the reagent disks A and B.
Each reagent disk is represented by two rings. The inner

ring has 10 positions for reagent cassettes and the outer
ring 25 positions; that means, 70 positions on one module.
Each reagent cassette is subdivided into three segments.

The colors of each segment correspond to the following
statuses:

21 Overview menu

Choose a reagent disk (A or B) to magnify the graphic of

the selected reagent disk.
Choose a single reagent cassette by choosing a segment.

Detailed information about the reagent cassette (e.g.,
Position, Test Name, Remaining Tests, and Calibration Date)
is displayed next to the graphic.
u See Detail area (c 701/c 702 module) (1318)
Roche Diagnostics
Reagent Overview window (c 701/c 702 module) 1317
Temperature The field below each graphic of the reagent disks displays
the temperature of the corresponding reagent disk.
Inventory area
The Inventory area displays the amount of system reagents

on the selected module:
• CellCln1 (NaOH-D) and CellCln2 (acid wash): Cell
cleaner
• SmpCln1 and SmpCln2: Sample probe cleaner
Volume OK
Container empty

21 Overview menu
Roche Diagnostics
1318 Detail area (c 701/c 702 module)
Detail area (c 701/c 702 module)

This area displays information about the selected reagent.
w Detail area for a selected reagent cassette
Upper section
Position This field displays the position of the reagent cassette

(A = left, B = right reagent disk).
Type This field displays the type of reagent. The type of reagent
depends on the module selected.
Name This field displays the name of the system reagent.
R. Pack Lot ID This field displays the reagent lot number.
R. Pack Seq. No. This field displays the reagent cassette sequence number.
First Registration Date and Time This field displays the date and time when the reagent was
21 Overview menu
first registered.
Exp. Date This field displays the expiry date of the reagent in the
corresponding position.
Status This field displays a reagent’s status of precedence.

Possible values are Current, SB1, SB2, SB3…
Roche Diagnostics
Detail area (c 701/c 702 module) 1319
Current Reagent cassette currently in use.
SB1 Standby reagent 1

The reagent which will be used after the
current reagent.

The reagent which will be used after SB1
reagent.
Remaining Volume If a reagent is used for multiple applications, this field

displays the remaining volume of the corresponding
reagent.
Lower section
The appearance of this section depends on the selected

reagent cassette. For detergents, only a list of tests is
displayed. For reagents, a table is displayed that shows
details about the tests for which this reagent is being used.
Test This field displays the name(s) of the application(s) using

this reagent.
Remaining Tests This field displays the number of tests remaining for the
corresponding reagent.
Calibration Date This field displays the date of calibration.
Calibration Type This field displays whether a calibration is a lot or a reagent

cassette calibration.
Button
R. Pack Mask/R. Pack Unmask Use this button to mask a selected reagent cassette
temporarily. This reagent cassette will not be used for
analysis. For masked reagent cassettes, the button
toggles to R. Pack Unmask. Masked reagent cassettes are
21 Overview menu
indicated in red (Caution) because the reagent is
unavailable at the moment.
q R. Pack Unmask cannot be carried out during

operation.
u Masking and unmasking reagent cassettes (314)
Roche Diagnostics
1320 Reagent Manager Overview window (c 702 module)
Reagent Manager Overview window (c 702

module)
Select button for reagent manager of c 702 module
sample buffer.
f Reagent > Setting > Reagent Manager Overview
w Reagent Manager Overview window (c 702 module)
Use this window to view the status of the reagent cassettes

present on the buffer rotor of the reagent manager.
Additionally, this window allows you to control these
reagent cassettes manually and to reset the cap counter
of the cap waste box.
Select one of the charts in the lower area to select a

reagent cassette.
21 Overview menu
u For a description of tasks performed from this window,

see:
Emptying the cap waste box of the c 702 module (361).
Upper area (status and legend area)
From left to right, the upper area consists of the following

three sections:
• A graphic legend for the reagent cassette charts below
• A status indicator of the cap waste box
• A graphic status indicator of the buffer rotor
Roche Diagnostics
Reagent Manager Overview window (c 702 module) 1321
A B C
A Graphic legend for reagent cassette charts B Status indicator of waste box
C Status indicator of buffer rotor
w Upper area
Graphic legend for reagent cassette charts This chart explains the elements used on the reagent
cassette charts in the lower area. The following elements
are indicated:
Open/Close Chart that explains the colors of the

reagent caps:
o Cap opened: White
o Cap closed: Blue
OBS Remaining onboard stability time (OBS)

in hh:mm;
the urgency of OBS is indicated by
colors:
o More than 2 hours: None (white)
o Less than 2 hours: Warning (yellow)
o Less than 0 hours: Caution (red)
Cap Color of the two reagent caps:

o Cap opened: White
o Cap closed: Blue
Pos Position number in the buffer rotor
Square fields Assay names available for this reagent

cassette (up to 4 assay names), and
number of remaining tests or volume
Calib. Availability of a valid calibration for this

reagent cassette:
o Valid calibration available: White
21 Overview menu
o Valid calibration not available:
Yellow
Waste Box – Number of caps This field indicates the number of reagent caps currently
collected in the cap waste box.
Graphic status indicator of buffer rotor This chart displays the reagent cassette positions on the
buffer rotor. Positions currently occupied are displayed
with a white background. Empty positions are displayed
with a black background. In the center of the chart, the
temperature inside the buffer rotor is displayed.
Roche Diagnostics
1322 Reagent Manager Overview window (c 702 module)
Lower area (reagent cassette charts)
The lower area shows the status of each reagent cassette

on the buffer rotor using graphic charts. Select one of the
charts to control this reagent cassette manually.
Reagent disk selection list box This list box allows the manual change of the target
reagent disk for the corresponding reagent cassette if it
was loaded in Buffering mode.
q The list box can only be changed if the following

conditions are met:
o The reagent cassette was loaded in Buffering mode.
o The module is in Standby or Operation mode.
o The test(s) was/were assigned to both reagent disks.
o The status shown below the list box is not Loading… or
Take out….
The text field below displays the current status of the

reagent cassette. The possible statuses are:
• Buffering: The reagent cassette will remain in the
reagent manager until needed.
• Direct: The reagent cassette will be loaded as soon as
possible.
• Reserve: The reagent cassette is reserved for loading
during the next transfer session.
• Loading …: The reagent cassette is currently loading.
• Take out (displayed in black): The reagent cassette is
reserved for unloading (initiated by user).
• Take out (displayed in red): The reagent cassette is
reserved for unloading and waiting for any reason
(unloading was initiated by the system).
• Take out …: The reagent cassette is currently unloaded.
q Be sure to choose the Update button after you have

21 Overview menu
manually selected or changed a reagent disk for a reagent

cassette.
Buttons
Waste Box Reset Use this button to reset the counter after you have
emptied the cap waste box.
u See Emptying the cap waste box of the c 702
module (361)
Roche Diagnostics
Reagent Manager Overview window (c 702 module) 1323
Update Use this button to save any changes.

• After selecting or changing the target reagent disk
• After choosing the Loading Reserve button or Loading
button
Loading Reserve Use this button to load the selected reagent cassette(s)
during the next transfer session (together with other
reagent cassettes) to the specified reagent disk. Be sure to
choose the Update button after choosing this button.
Loading Reserve Cancel This button is only displayed if Loading Reserve was
selected for a reagent cassette. Use this button to cancel
the loading reserve for selected reagent cassette(s). Be
sure to choose the Update button after choosing this
button.
Loading Use this button to load the selected reagent cassette(s)

immediately to the specified reagent disk. Be sure to
choose the Update button after choosing this button.
q If Loading is not available (message “This function

cannot be performed in the current system mode.”
appears), choose Loading Reserve. Afterwards Loading
can be ordered.
Take Out Use this button to eject the selected reagent cassette(s)
from the buffer rotor.
Detail Use this button to display the Detail area where you can
view details about the selected reagent cassette.
u See Detail window (c 702 module) (1324)
21 Overview menu
Roche Diagnostics
1324 Detail window (c 702 module)
Detail window (c 702 module)

f Overview > Symbol button > Detail
On Overview menu, select the symbol for reagent
manager of c 702 module.
f Reagent > Setting > Reagent Manager Overview > Detail
w Detail window for a selected reagent cassette
This window displays information about a selected reagent

cassette on the reagent manager.
Upper section
R.Pack Set Grouped Pairing Position If the reagent cassette is part of a reagent kit, this field
displays the position of the second reagent cassette.
Position This field displays the position of the reagent cassette on

the buffer rotor.
Type This field displays the type of reagent (assay reagent,

21 Overview menu
detergent, or diluent).
Name This field displays the name of detergents or diluents.

reagent.
Roche Diagnostics
Detail window (c 702 module) 1325
Lower section


this reagent.
Type This field displays the type of reagent. For assay reagents,
the pipetting time points R1/R2/R3 are displayed.
Calibration Succeed This field displays whether a lot calibration or other

calibration is available for reagent disk A or B.
21 Overview menu
Roche Diagnostics
1326 Take Out window
Take Out window

f Overview > Symbol button > Take out
On Overview menu, select the symbol for reagent
manager of c 702 module.
f Reagent > Setting > Reagent Manager Overview > Take
out
w Take out window
This window allows to eject the selected reagent

cassette(s) from the buffer rotor.
u See Unloading reagent cassettes from the c 702
module reagent manager (359).
Select R. Pack Select this option to unload the previously selected

reagent cassette from the buffer rotor to the return port.
All R. Pack Select this option to unload all reagent cassettes from the
buffer rotor to the return port.
21 Overview menu
Roche Diagnostics
Reagent Pack Unloading Area window (c 702 module) 1327
Reagent Pack Unloading Area window

(c 702 module)
Select button for reagent pack unloading area.
Use this window to view the status of the reagents present

on the unloading tray of the c 702 module. On the left side,
this window displays the reagent cassettes on the reagent
disks that are reserved for transfer to the unloading tray.
A B
A Left lane of unloading B Right lane of unloading
tray tray
Reservation R. Pack area
Test list This list displays the reagent cassettes that will be
transferred to the unloading tray during the next transfer
session.
Receive R. Pack area
The Receive R. Pack area shows graphic charts for the

reagent cassettes present on the unloading tray. If there is
21 Overview menu
a reagent cassette containing reagent, it is displayed in the
right column along with the cause.
Test This field displays the assay names this reagent cassette
was used for.
Roche Diagnostics
1328 Reagent Pack Unloading Area window (c 702 module)
Cause This field is displayed only if the reagent cassette was

unloaded for a reason other than that it is empty. Possible
causes are:
Manual Manually unloaded by the operator for

some reason
Foam Foam detected inside this reagent

cassette
(Foam) Foam detected in the other reagent

cassette of this reagent kit
Break Up Reagent kit was split up

21 Overview menu
Roche Diagnostics
Reagent Overview window (c 502 module)

Select button for reagent overview on c 502 module.
w Reagent Overview window (c 502 module)

Overview menu.

reagents.
u See Reagent Level window (1729).

21 Overview menu
or purple.
reagents (288).
u For information about photometric reagents, see:
Contents area

Reagent area.
Roche Diagnostics
1330 Reagent Overview window (c 502 module)


meaning:
Active
Preparation
Warning
Caution
There is no more reagent available for this assay on this
module.
Stand-by
Valid
Requested
calibration.
Failed
Valid
21 Overview menu
Requested
measurement.
Failed
manager.
N.A.
Not applicable.
Roche Diagnostics

this module.
Free Pos.
Invalid
Reagent area

loaded on the reagent disk. This area comprises a graphic
representing the reagent disk.
The reagent disk is represented by a ring. The inner ring

has 24 positions for reagent cassettes and the outer ring
36 positions; that means, 60 positions on one module.
Each reagent cassette is subdivided into three segments.

The colors of each segment correspond to the following
statuses:

Detailed information about a reagent Choose a single reagent cassette by choosing a segment.
cassette Detailed information about the reagent cassette (e.g.,
Position, Test Name, Remaining Tests, and Calibration Date)
21 Overview menu
Roche Diagnostics
1332 Reagent Overview window (c 502 module)
w Detail window for a selected reagent cassette
u See Detail area (c 502 module) (1333)
Inventory area
The Inventory area displays the amount of system reagents

on the selected module.
• CellCln1 (NaOH-D) and CellCln2 (acid wash): Cell
cleaner
• SmpCln1 (basic wash) and SmpCln2 (acid wash):
Sample probe cleaner
• ECO-D
Volume OK

21 Overview menu
Container empty

Roche Diagnostics
Detail area (c 502 module) 1333
Detail area (c 502 module)

w Detail area for a selected cobas c pack
Upper section
Position This field displays the position of the reagent cassette.
Type This field displays the type of reagent. The type of reagent
depends on the module selected.
Name This field displays the name of the system reagent.
first registered.
21 Overview menu

Current Reagent (cobas c pack) currently in use.
SB1 (Standby reagent 1) The reagent which

will be used after the current reagent.

will be used after SB1 reagent.
Roche Diagnostics
1334 Detail area (c 502 module)

reagent.
Lower section


this reagent.
Calibration Date This field displays the date of calibration.
Calibration Type This field displays whether a calibration is a lot or a reagent

cassette calibration.
Button

operation.
u See Working with reagent masking (312).

21 Overview menu
Roche Diagnostics
Reagent Overview window (e 801 module)

Select button for reagent overview on e 801 module.
w Reagent Overview window (e 801 module)

Overview menu.

reagents.

21 Overview menu
or purple.
reagents (288).
u For information about reagents for the e 801 module,
see:
Reagents and consumables of the e 801 module (390)
Contents area

Reagent area.
Roche Diagnostics
1336 Reagent Overview window (e 801 module)


meaning:
Active
Preparation
Warning
Caution
There is no more reagent, diluent, or pretreatment
available for this test on this module.
An assay or pretreatment reagent cassette could not be
linked to required partner reagent cassette (link status
Free). Partner reagent cassette is not on board.
Stand-by
Valid
Requested
calibration.
Failed
21 Overview menu
Valid
Requested
measurement.
Failed
manager.
N.A.
Not applicable.
Roche Diagnostics

this module.
Free Pos.
Invalid
Reagent area

representing the reagent disk by a ring with 48 positions
for reagent cassettes.
Each reagent cassette is subdivided into three main

segments. The middle and outer segments are subdivided
in two subsections corresponding to the two measuring
channels. The colors of each segment correspond to the
following statuses:

Temperature The field at the bottom right of the graphic of the reagent
disk displays the temperature inside the reagent disk.
21 Overview menu
Roche Diagnostics
Position, Test Name, Remaining Tests, Calibration Date, …)
w Detail window for a selected assay reagent cassette
u See Detail area (e 801 module) (1340)
Inventory area
The Inventory area displays the amount of system

reagents, magazines, magazine waste and solid waste on
the selected module. The abbreviations have the following
meaning:
• PC1/PC2 (top): ProCell II M bottles 1 and 2
• CC1/CC2: CleanCell M bottles 1 and 2
• PreClean 1/2: PreClean II M bottles 1 and 2
• PC1/PC2 (bottom): Expiry date and onboard stability in
days for ProCell II M bottles 1 and 2
21 Overview menu
• Magazine: Full magazines with AssayTips and

AssayCups
• Magazine waste: Empty magazines
• Waste 1/2: Solid waste for AssayTips and AssayCups
Roche Diagnostics
Magazine Magazine Waste Waste
Each green segment of the bar represents:

One full magazine The place for one empty magazine The cups/tips from one magazine
Examples:
The number 4 indicates that 4 full The number 8 indicates that there is The numbers 14 and 15 indicate that 14
magazines are onboard. space for 8 additional empty magazines or 15 additional magazines can be
(7 magazines are already in the exchanged before the Wasteliner is full.
compartment).
y Explanation of bar charts
PC1/PC2, CC1/CC2 PreClean Magazine Magazine Waste Waste

Volume OK
One bottle ≤ 20 % One bottle empty One magazine Only place for 1 empty Only place for the tips
remaining magazine and cups from
1 magazine
Both bottles empty Both bottles empty Magazine empty Magazine waste full Solid waste container
full
y Color scheme for Inventory area
Button
Inventory Update Use the Inventory Update button to execute an inventory

update for an e 801 module. This button is a short cut to
the Inventory Update maintenance window.
u See Inventory Update window (1776).
21 Overview menu
Roche Diagnostics
1340 Detail area (e 801 module)
Detail area (e 801 module)

w Detail area for a selected diluent reagent cassette

21 Overview menu
w Detail windows for two linked assay reagent cassettes as part of a linked kit
Upper section
Roche Diagnostics
Type This field displays the type of reagent: Assay, diluent (DIL),
or pretreatment (PRE).
u See Abbreviations of reagents (1556).
Name This field displays the name of the test using this reagent.

Current Reagent (cobas e pack) currently in use.


R. Pack Lot ID This field displays the reagent cassette lot number.
u For information about the priority of reagent cassettes,
see Priority of reagent cassettes (406).
Exp. Date This field displays the expiry date of the reagent or diluent.
(Remaining Volume) corresponding reagent or pretreatment. For diluents, this
field displays the remaining volume of this reagent
cassette.
first registered.
Lower section
Calibration This table lists all tests which use this reagent cassette and
their respective calibration data. The date and type given
refer to the last successful calibration for measuring
channel 1 and 2.
21 Overview menu
Roche Diagnostics
PT-Link This table lists those tests from the Calibration table which
require pretreatment. The columns of this table display
information about linked pretreatment and assay reagent
cassettes. The rows of this table correspond to the rows of
the Calibration table above.
PT Link Status This column displays whether an assay

reagent cassette is linked with a
pretreatment reagent cassette (Linked)
or not (Free).
PRE R. Pack Seq. For assay reagent cassettes, this

No. column displays the sequence number of
(ASSAY R. Pack the linked pretreatment reagent
Seq. No.) cassette and vice versa.
PRE Position For assay reagent cassettes, this

(ASSAY Position) column displays the position of the
linked pretreatment reagent cassette
and vice versa.
u See Linking pretreatment and assay reagent cassettes

Linked Kit If the selected reagent cassette is part of a linked kit, this
table specifies the other test of this linked kit. The columns
of this table display information about the linked reagent
cassette.
ASSAY R. Pack This column displays the sequence

Seq. No. number of the linked reagent cassette.
Position This column displays the position of the

linked reagent cassette.
u Linked kits for cobas e flow duo tests (394)

e 801 module (427)
Test name For diluents, this list displays the assay names for which
this diluent is used.
21 Overview menu
Button

operation.
Roche Diagnostics
Temperature window (e 801 module)

Select button for temperature.
w Temperature window (e 801 module)
The Temperature window displays the temperature of the

listed components of the selected e 801 module. When a
temperature value is invalid, “----” is displayed.
Actual This table column displays the current temperatures of the

following sensors:
Reagent Disk Reagent storage temperature
Incubator Incubator temperature
PC/CC Temperature of the preheater for

ProCell II M and CleanCell M solution in
the detection unit
21 Overview menu
Detection Unit 1/2 Temperature in the measuring channel 1

or 2
PreClean Temperature of the preheater for

PreClean II M solution
PreWash Unit Temperature at the pre-wash station
Reservoir Temperature at the PC/CC cups in the

detection unit
Ambient This field displays the room temperature.
Roche Diagnostics
1344 Temperature window (e 801 module)
Reagent Cooling Unit This field indicates the status of the reagent cooling unit.
The following status values are displayed:
• Normal: The temperature is controlled and monitored
within the target temperature range.
• Preparation: The temperature of the reagent cooling
unit has not reached the target temperature yet.
• Thermistor is abnormal: Malfunction of the temperature
sensor. Contact your Roche Service representative.
• Temperature is abnormal: The temperature is outside
the control range. Contact your Roche Service
representative.
• Power off
21 Overview menu
Roche Diagnostics
Reagent Overview window (e 602 module)

Select button for reagent overview on e 602 module.
w Reagent Overview window (e 602 module)

Overview menu.

reagents.

or purple.
21 Overview menu
reagents (288).
u For information about reagents for the e 602 module,
see:
Reagents and consumables on the e 602 module (440)
Contents area

Reagent area.
Roche Diagnostics


meaning:
Active
Preparation
Warning
Caution
There is no more reagent, diluent, or pretreatment
available for this test on this module.
An assay or pretreatment reagent cassette could not be
linked to required partner reagent cassette (link status
Free). Partner reagent cassette is not on board.
Stand-by
Valid
Requested
calibration.
Failed
21 Overview menu
Valid
Requested
measurement.
Failed
manager.
N.A.
Not applicable.
Roche Diagnostics

this module.
Free Pos.
Invalid
Reagent area

representing the reagent disk by a ring with 25 positions
for reagent cassettes.
Each reagent cassette is subdivided into three main

segments. The middle and outer segments are subdivided
in two subsections corresponding to the two measuring
channels. The colors of each segment correspond to the
following statuses:
• Reagent cassette status (inner segment)

• Calibration status (middle segment)
• QC status (outer segment)
21 Overview menu
Roche Diagnostics
Position, Test Name, Remaining Tests, Calibration Date, …)
w Detail window for a selected assay reagent cassette
u See Detail area (e 602 module) (1350)
Inventory area
The Inventory area displays the amount of system

reagents, magazines, magazine waste and solid waste on
the selected module. The abbreviations have the following
meaning:
• PC1/PC2: ProCell M bottles 1 and 2
• CC1/CC2: CleanCell M bottles 1 and 2
• PreClean 1/2: PreClean M bottles 1 and 2
• ProbeWash 1/2: ProbeWash M bottles 1 and 2
• Magazine: Full magazines with AssayTips and
AssayCups
21 Overview menu
• Magazine waste: Empty magazines

• Waste 1/2: Solid waste for AssayTips and AssayCups
Roche Diagnostics
Magazine Magazine Waste Waste
Each green segment of the bar represents:

One full magazine The place for one empty magazine The cups/tips from one magazine
Example: The number 7 indicates that …
… 7 full magazines are onboard. … there is space for 7 additional empty … 7 additional magazines can be
magazines (5 magazines are already in the exchanged before the Wasteliner is full.
compartment).
y Explanation of bar charts
PC1/PC2, CC1/CC2 PreClean, ProbeWash Magazine Magazine Waste Waste

Volume OK
One bottle ≤ 20 % One bottle empty One magazine Only place for 1 empty Only place for the tips
remaining magazine and cups from
1 magazine
Both bottles empty Both bottles empty Magazine empty Magazine waste full Solid waste container
full
y Color scheme for Inventory area
Button
Inventory Update Use the Inventory Update button to execute an inventory

update for an e 602 module. This button is a short cut to
the Inventory Update maintenance window.
u See Inventory Update window (1776).
21 Overview menu
Roche Diagnostics
Detail area (e 602 module)

w Detail area for a selected assay reagent cassette

21 Overview menu
w Detail window for a selected pretreatment reagent cassette (left) and the linked assay reagent cassette (right)
Upper section
Type This field displays the type of reagent: Assay, diluent (DIL),
or pretreatment (PRE).
u See Abbreviations of reagents (1556).
Name This field displays the name of the test using this reagent.
Roche Diagnostics
R. Pack Lot ID This field displays the reagent cassette lot number.
u For information about the priority of reagent cassettes,
see Priority of reagent cassettes (444).
first registered.
Exp. Date This field displays the expiry date of the reagent or diluent.

Current Reagent (cobas e pack) currently in use.


(Remaining Volume) corresponding reagent or pretreatment. For diluents, this
field displays the remaining volume of this reagent
cassette.
PT Link Status This field displays whether an assay reagent cassette is

linked with a pretreatment reagent cassette (Linked) or not
(Free).
u See Linking pretreatment and assay reagent cassettes
PRE R. Pack Seq. No. For assay reagent cassettes, this field displays the
(ASSAY R. Pack Seq. No.) sequence number of the linked pretreatment reagent
cassette and vice versa.
PRE Position For assay reagent cassettes, this field displays the position
(ASSAY Position) of the linked pretreatment reagent cassette and vice
versa.
21 Overview menu
Lower section
Calibration Date These fields display the date and time of the last
successful calibration for measuring channel 1 and 2.
Calibration Type These fields display the calibration type of the

corresponding reagent for measuring channel 1 and 2.
Test name For diluents, this field displays the assay names for which
this diluent is used.
Roche Diagnostics
Button

operation.

21 Overview menu
Roche Diagnostics
Temperature window (e 602 module)

Select button for temperature.
w Temperature window
The Temperature window displays the temperature of the

listed components of the selected e 602 module. When a
temperature value is invalid, “----” is displayed.
Ambient This column displays the room temperature.
Actual This table column displays the current temperature of the

corresponding sensor.
21 Overview menu
Roche Diagnostics
1354
21 Overview menu Temperature window (e 602 module)
Roche Diagnostics
1355
Table of contents
Global buttons and windows 22
This chapter provides a detailed description of the global

buttons and global windows, such as the Stop, Alarm, Print
and Start windows.
The functions of the global windows relate to the system
as a whole. You can access the global windows via the
global buttons on the right-hand side of the screen at any
time regardless of which part of the software is currently
displayed.
In this chapter 22
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1357
Stop window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1362
Logoff window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1363
22 Global buttons and windows

Logon window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1364
S. Stop window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1365
Alarm window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1366
Sound window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1369
Monitor window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1370
Print window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1372
History window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1374
Print Range window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1377
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1378
Workplace print window . . . . . . . . . . . . . . . . . . . . . . . . . 1379
Result List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1379
Reaction Monitor List . . . . . . . . . . . . . . . . . . . . . . . . 1383
Requisition List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1388
Precision Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1391
Reagent print window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1393
Reagent Load/Unload List . . . . . . . . . . . . . . . . . . . . 1393
Reagent Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1397
Roche Diagnostics
1356
Table of contents
Calibration print window . . . . . . . . . . . . . . . . . . . . . . . . . 1400

Calibrator Load List . . . . . . . . . . . . . . . . . . . . . . . . . . 1400
Calibration Reaction Monitor List . . . . . . . . . . . . . . 1403
Calibration Trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1407
Calibration Result List . . . . . . . . . . . . . . . . . . . . . . . . 1414
Calibration Request List . . . . . . . . . . . . . . . . . . . . . . 1416
QC print window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1418
QC Load List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1418
QC Request List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1420
Utility print window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1422
Alarm Trace. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1422
Communication Trace . . . . . . . . . . . . . . . . . . . . . . . . 1428
Operator ID Trace. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1430
Cumulative Operation List . . . . . . . . . . . . . . . . . . . . 1432
Application Parameters. . . . . . . . . . . . . . . . . . . . . . . 1437
Profile List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1439
Rack Archival Report . . . . . . . . . . . . . . . . . . . . . . . . . 1440
Cell Blank Measurement . . . . . . . . . . . . . . . . . . . . . . 1443
Maintenance Report . . . . . . . . . . . . . . . . . . . . . . . . . 1444
Cuvette History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1448
Rack Delivery Trace . . . . . . . . . . . . . . . . . . . . . . . . . . 1452
Automatic Calibration Monitor report . . . . . . . . . . . . . . 1454
Automatic Maintenance reports . . . . . . . . . . . . . . . . . . 1463
Start window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1473
Start Up Pipe Setting window. . . . . . . . . . . . . . . . . . . . . 1477
Automatic Rerun window. . . . . . . . . . . . . . . . . . . . . . . . . 1478
Time To Unload window (c 702 module) . . . . . . . . . . . . 1479
Rack Reception Mode window . . . . . . . . . . . . . . . . . . . . 1480

CLAS Connection window. . . . . . . . . . . . . . . . . . . . . . . . 1481
Masking window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1482
Module Masking window . . . . . . . . . . . . . . . . . . . . . . . . . 1484
Default Profile window. . . . . . . . . . . . . . . . . . . . . . . . . . . 1486
Confirmation window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1487
No help available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1488
Roche Diagnostics
Overview 1357
Overview
A C
B
A Status line C Help buttons

B Main menu tabs and Overview button D Global buttons
In the user interface, the following buttons and functions

are displayed all the time:
• Status line
Use the status line to view information about the
current system condition.
• Main menu tabs and Overview button
Use the main menu tabs to access the corresponding

submenus.
• Help buttons
Use these buttons to get more information about the
system.
• Global buttons
Use these buttons to access the global windows.
Global windows provide access to essential processes
such as system stop, alarm handling, printing of
reports, and starting routine operation.
The help and global buttons are accessible all the time -
regardless of the current screen display.
Main menu tabs and Overview button (1358)
Help buttons (1359)
Global buttons (1359)
Work Flow Guide area (1283)
Module Overview area (1286)
Roche Diagnostics
1358 Overview
Main menu tabs and Overview button
The main menu tabs provide access to the submenus of the

main menu.
Workplace Use the Workplace menu to select tests, comments, assign

sample ID numbers and position numbers to samples, as
well as review, backup, edit, delete, and send data to the
data manager. The Workplace menu consists of the Test
Selection submenu, the Data Review submenu, and the
Calib. Review submenu. Use the tabs at the top left of the
Workplace menu to switch between the 3 submenus.
Reagent Use the Reagent menu to view detailed reagent information

and to manually add and remove reagents. This menu
consists of 2 submenus, the Setting and Status submenus.
Calibration Use the Calibration menu to request calibrations and to

define calibrators. It is also used to view the reaction
curves for the most recent calibration performed. The
calibration mode for the next start-up calibration or for an
intermediate calibration can be determined from here. If an
intermediate calibration is necessary, it can be requested
by test, calibration type and by detector channel. The
Calibration menu consists of 3 submenus, Status,
Calibrators, and Install, which can be activated by using the
corresponding tabs along the top of the menu.
QC Use the QC menu to install controls or view control results.

It consists of 4 submenus, Status, Run Status, Controls, and

Install, which can be activated by using the corresponding
tabs along the top of the QC menu.
Utility The Utility menu is used to enter system parameters,

application parameters, maintenance settings, and system
settings. It consists of 5 submenus (System, Maintenance,
Application, Special Wash, and System Configuration) that
are displayed by using the corresponding tabs along the
top of the menu.
Overview The Overview menu is the central menu used for daily
operations. From here you can view the status of all
modules, check the amount of reagents available, and
perform all steps that are necessary for trouble-free daily
operation.
Roche Diagnostics
Overview 1359
Help buttons
Direct Help
Choose the Direct Help button and then an element of

interest on the screen to get information about this
element.
F1 Help
Use this button to open the Help window. The context-

sensitive entry displays text relating to your current
location in the software.
Global buttons
The buttons on the right of the user interface are referred

to as global buttons because they can be accessed
regardless of which part of the software is currently
displayed.
Stop (global button) Use this button to terminate a maintenance function or to

interrupt a running analysis and force all modules to stop
processing at the end of the current mechanical cycle.
u For more information, see Stop window (1362).
Logoff (global button) The analyzer remains powered on and in operation after

you have logged off. It is possible to print a trace of the
operators who have used the analyzer.
Logoff window (1363)
Operator ID Trace report (1431)
S. Stop (global button) Use this button to stop further sample processing. After
confirmation, the instrument goes into S. Stop (sampling
stop) status. New samples and samples already on the
MSBs will not be processed. Processing of the samples on
the analyzer modules is continued until results are
available.
u For more information, see S. Stop window (1365).
Alarm (global button) Use this button to view instrument alarm information. If an
alarm was issued, the Alarm global button flashes. In this
case it is necessary to open the Alarm window to view the
alarm. The Alarm window identifies any instrument alarm
conditions.
u For more information, see Alarm window (1366).
Roche Diagnostics
1360 Overview
Monitor (global button) Use this button to open the Monitor window. In this window
sample and control results can be checked, as well as the
Calibration Monitor report.
u For more information, see Monitor window (1370).
Print (global button) Use this button to open the Print window and select reports
or lists to be printed or viewed. The software is context-
sensitive and automatically displays the Print window
corresponding to the software area currently displayed.
u For more information, see Print window (1372).
Start (global button) Use this button to open the Start window and start an
analysis run or to select specific operating parameters
(e.g., Masking, Time To Unload or Clas Connection).
u For more information, see Start window (1473).
OK, Cancel, Execute, Update, and other standard buttons
The following buttons are used throughout the software.

These buttons are explained below.
OK
Accept the changes and entries made in a window and

close the window.
Cancel
Close the window without saving the changes and entries

made in a window.
Yes
Accept the changes made in a window, execute the action

of the window (e.g., Delete) and close the window.
No
Close the window without saving the changes made in a

window or without executing the function of the window
(e.g., Delete).
Close
Close the window.
Roche Diagnostics
Overview 1361
Save
Save the changes made to the submenu/window currently

displayed. When changes have been made, this button
turns yellow.
Update
Update the changes made to the submenu/window

currently displayed. When changes have been made, this
button turns yellow.
Execute
Accept the changes made in a window, execute the action

of the window and close the window.
Roche Diagnostics
1362 Stop window
Stop window
f Stop
f Press F4
Use this window to force all modules to stop processing at

the end of the current mechanical cycle. The Stop window
asks for confirmation before sending the Stop command.
Choose Yes to confirm or choose No to cancel the
command.
q All sampling and sample processing will be stopped

and results in process will be lost.
Only stop the operation if there is no other option.
Roche Diagnostics
Logoff window 1363
Logoff window
f Logoff
Use this window if the operator changes.
The user interface is faded out for a moment and faded in

for the next operator to log on. The instrument remains
powered on and in operation after you have logged off. It is
possible to print a trace of the operators who have used
the system.
Logon window (1364)
Add window (1675).
Roche Diagnostics
1364 Logon window
Logon window
If the system is in password protection mode, the Logon
window is displayed whenever the system is powered on or
whenever a logoff has been performed in the Logoff
window.
Operator ID Type the operator ID in the Operator ID text box. The

operator ID is defined in Utility > System > Operator List.
u See Operator List window (1665).
Password Type the password in the Password text box (up to

16 characters, upper or lower case). The password is
defined the first time an operator ID is used.
Logon Choose Logon to log on to the system.
q It is possible to print a trace of the operators who

have used the system.
Roche Diagnostics
S. Stop window 1365
S. Stop window
f S. Stop
f Press F3
Use this window to perform a sample stop. The S. Stop

window asks for confirmation before sending the S. Stop
command. Choose Yes to confirm or choose No to cancel
the command.
After confirmation, the instrument goes into S. Stop

(sampling stop) status and reacts in the following way:
• New racks are not loaded to the instrument.
• Sample processing from racks in the analyzer modules
is continued. When sampling is completed, the racks
are moved to the rack unloading area.
• However, racks in the module sample buffers (MSB) are
not processed but moved to the rack unloading area
automatically.
After all racks have been moved to the unloading area, the
instrument goes into Standby.
q A sample stop can only be performed when the

system is in operation.
Roche Diagnostics
1366 Alarm window
Alarm window
f Alarm
f Press F11
f Overview > Module or Component button > Alarm
Use this window to view instrument alarm information and

to change the sound of the audible alarms. The
Maintenance submenu can also be accessed from this
window if maintenance is required as indicated by an alarm.
All alarms are stored on the system hard disk and can be
printed via the Alarm Trace report from the Print window
Utility tab.
q Alarm codes are not duplicated. If an alarm is issued

with the same alarm code and subcode more than once,
the alarm is not updated with the new information.
Therefore, delete each alarm after remedying the
situation.
If an instrument alarm is displayed in the Alarm List, follow
the remedy in the Remedy field to troubleshoot the alarm.
Only after completing the remedy described should the
alarm be deleted.
Instrument alarms are only displayed in the user interface.
They are neither described nor listed in the Operator’s
Manual or Online Help.

Troubleshooting system alarms (284)

Alarm Trace (1422)
Alarm list
Use this list to view all alarms issued. The alarm list can be
sorted by any of its 5 columns: Code, Module, Level, Alarm
(Name), and Date/Time. An arrow in the appropriate column
header distinguishes the selected column and sorting
order.
Code This column displays the alarm code and subcode. Choose
the column header to sort the list numerically by alarm
code.
Roche Diagnostics
Alarm window 1367
q It is important to note the alarm code in case you have

to contact technical support. You can print deleted
instrument alarms from the Alarm window via Print > Utility
> Alarm Trace.
u See Alarm Trace (1422).
Module This column displays the module for which the alarm code
was issued. Choose the column header to sort the list by
module.
Level This column displays the level of each alarm. Choose the
column header to sort by alarm level, with the highest level
alarms displayed first (i.e., Stop, S. Stop, Caution).
Alarm This column displays the name of the alarm. Choose the
column header to sort the list alphabetically by alarm
name.
Date/Time This column displays the date and time the alarm occurred.
Choose the column header to sort the list by date and time.
Fields
These fields display the alarm, alarm code, module, level,

description and remedy of the alarm selected in the Alarm
List.
Alarm This field displays the name of the selected alarm.

Code This field displays the code and subcode of the selected
alarm.
Module This field displays the module of the selected alarm.
Level This field displays the level of the selected alarm.
Description This field displays the description for the selected alarm.
Remedy This field displays the remedy for the selected alarm.
Follow the steps in this field to troubleshoot the alarm.
q It may be helpful, when performing a remedy, to print

a screenshot of the Alarm window and an Alarm Trace
report.
To print a screenshot, press the Shift and Print Screen key
at the same time.
u See Alarm Trace (1422).
Roche Diagnostics
1368 Alarm window
Buttons
Maintenance If maintenance is required, use this button to initiate the

required maintenance.
u See Maintenance submenu (1744).
Delete Use this button to delete the alarm selected in the Alarm
List. Single alarms, a range of alarms, or nonconsecutive
alarms may be selected and deleted.
New Alarm Use this button to display any new alarms that occur while
viewing the Alarm window. If a new alarm occurs, this
button turns yellow or red, depending on the alarm level.
After choosing the New Alarm button, the screen is
refreshed and the new alarm(s) is displayed.
Sound Use this button to set alarm patterns and tones for the
different alarm levels. Also, use this button to enable and
disable audible alarms. Choosing this button displays the
Sound window.
u See Sound window (1369).
Roche Diagnostics
Sound window 1369
Sound window
f Alarm > Sound
Use this window to turn audible alarms on or off on the

control unit. The sound of the audible alarms can also be
changed.
u See Alarm Settings window (1722).
Sound Select this check box to activate the control unit audible
alarm. When the Sound check box is selected, the Tone and

Pattern controller are enabled.
Level This information column displays the different alarm levels

to which audible alarms can be assigned. The levels are
E.Stop (emergency stop), Stop, S.Stop (sampling stop) and
Caution.
u See Alarm types and levels (1157).
Sounds Use the corresponding controller to select the desired

sounds for the audible alarms on the control unit. There
are 10 sounds to choose from (1–10).
Test Use this column to test the sounds selected in the Tone
controller. Choose the play button to listen to a preview of
the selected tone and pattern. This button changes to stop
when the alarm is sounding. Choose the stop or OK button
to end the preview.
Roche Diagnostics
1370 Monitor window
Monitor window
f Monitor
f Press F10
This window is used to view latest measurement data, such

as patient, calibration, and QC results.
Routine Data This report field is the header for test results. It contains
data such as sample type, date, time, and operator ID.
Calibration Data This report field lists the calibration information on the
most recent calibration for the tests selected.
The calibration information is also printed in the Calibration

Monitor report in the History window.
u For more information, see Automatic Calibration
Monitor report (1454).
Control Data This report field is the header for QC results. It contains
data such as the sample type, date, time, control name,
and operator ID.
Final Data This report field lists the test results. It contains data such
as test name, module name, result, and existing alarm.
For control data it contains also the reagent pipetting time,

the control lot number and the control sequence number.
Sample x/x This field displays the current sample/total samples.
Roche Diagnostics
Monitor window 1371
Buttons
Refresh Use this button to refresh the Monitor window.
Previous Use this button to display the previous page.
Next Use this button to display the next page.
Delete Use this button to delete the selected page(s).
Roche Diagnostics
1372 Print window
Print window
f Print
f Press Print
w Print window (example)
Use the Print window to select the report to be printed or

viewed. The software is context-sensitive and
automatically displays the Print window corresponding to
the software area currently displayed.
u For information about printing a report, see:

Requesting a maintenance report (800).
The Print window displays the tabs: Workplace, Reagent,

Calibration, QC, and Utility. Selecting one of these tabs
displays the corresponding reports available. Select the
report to be printed or viewed from the list. Some reports
may require that specific parameters be defined prior to
viewing or printing.
Workplace print window (1379)
Reagent print window (1393)
Calibration print window (1400)
QC print window (1418)
Utility print window (1422)
Roche Diagnostics
Print window 1373
Tabs
Workplace Choose this tab to display the list of available reports

corresponding to the Workplace menu. Report options
include: Result List, Reaction Monitor List, Requisition List,
and Precision Check.
u See Workplace print window (1379).
Reagent Choose this tab to display the list of available reports

corresponding to the Reagent menu. Report options
include: Reagent Load/Unload List and Reagent Status.
u See Reagent print window (1393).
Calibration Choose this tab to display the list of available reports

corresponding to the Calibration menu. Report options
include: Calibrator Load List, Calibration Reaction Monitor
List, Calibration Trace, Calibration Result List and
Calibration Request List.
u See Calibration print window (1400).
QC Choose this tab to display the list of available reports

corresponding to the QC menu. Report options include: QC
Load List and QC Request List.
u See QC print window (1418).
Utility Choose this tab to display the list of available reports

corresponding to the Utility menu. Report options include:
Alarm Trace, Communication Trace, Operator ID Trace,
Cumulative Operation List, Application Parameters, Profile
List, Rack Archival Report, Cell Blank Measurement,

Maintenance Report, Cuvette History, and Rack Delivery
Trace.
u See Utility print window (1422).
Buttons
History Choose this button to display the History window. Use this
window to view and/or print reports currently in the print
buffer.
u See History window (1374)
Delete All This button is only available for some reports selected on
the Utility tab. Choose this button to delete the selected
report after confirmation.
Preview Choose Preview to store and display a preview of the

currently selected report in the History window.
Close Choose Close to close the Print window.
Roche Diagnostics
1374 History window
History window
f Print > History
Use this window to display the reports currently in the print

buffer. Select the appropriate report from the Report
Name list to display the desired report in the area on the
right side.
The number of pages that are stored of a report depends

on the file size of the report. If the storage capacity of the
print buffer is exhausted, the first page of the report is

deleted for every page that is added.
q The information is deleted from the History window

when you use one of the delete buttons.
u For an explanation of the reports, see:

Reports (1378)
Report Name list
Report Name This column displays the names of the reports stored in the
print buffer. Select a report to display it in the Preview area
on the right side of the window.
Date/Time This column displays the date and time when the report
was stored to the History window.
Roche Diagnostics
History window 1375
Preview area
This area displays a preview of a report currently selected

in the Report Name list. Use the scroll bars to view the
entire page of the report. Use the buttons below to move
between all viewable pages of the report.
Use this button to display the first page of the report

currently selected in the Report Name list.
Use this button to display the previous page of the report

currently displayed in the Preview area.
This field displays the number of the page currently

displayed in the Preview area and the number of pages for
the report selected in the Report Name list. If you want to
display a particular page of a report, enter the number of
the page in the text box and press the Enter key.
Use this button to display the next page of the report

currently displayed in the Preview area.
Use this button to display the last page of the report

currently selected in the Report Name list.
Use this button to zoom in or out of the page currently

displayed in the Preview area.
Buttons
Refresh When the print buffer is updated, this button turns yellow.

Choose the Refresh button when it is yellow to update the
History window with the updated information in the print
buffer.
Delete Use this button to delete one or more reports currently

selected in the Report Name list. Choosing this button
displays the Delete window. Choose Yes to confirm or
choose No to cancel the command.
Delete All Use this button to delete the entire contents of the Report
Name list. Choosing this button displays the Delete All
window. Choose Yes to confirm or choose No to cancel the
command.
Backup Use this button to backup one or more reports currently

selected in the Report Name list. This is only possible if a
storage medium (DVD) is inserted in the control unit. The
reports are saved as PDFs. Choosing the Backup button
displays the Backup window. Choose Yes to confirm or
choose No to cancel the command.
u See Archiving and deleting reports (614)
Roche Diagnostics
1376 History window
Print Out Use this button to print pages displayed in the Preview area
on the right side of the History window. Choosing this
button displays the Print Range window. Use this window to
define the pages to be printed from the print buffer.
u See Print Range window (1377).
Roche Diagnostics
Print Range window 1377
Print Range window

f Print > History > Print Out
Use this window to define the page(s) to be printed.
Page Range
Current Page Choose this option to print the page currently displayed in
the Preview area.
All Choose this option to print all pages of the report.
Pages Choose this option to print a range of pages of the report.

If this option is selected, the adjacent text boxes are
available. Enter the first number of the page range in the
first text box and the last number of the page range in the
second text box.
Button

Print Out Choose this button to print the selected pages of the
report.
Roche Diagnostics
1378 Reports
Reports
Several reports are generated by the system. This chapter
contains examples of the various reports and discusses
their content and use.
Some reports, such as the Photometer Check report, are

printed automatically by the system, whereas others are
selected manually from the global Print window.
Area Name Printed From

Workplace Result List (1379) Print > Workplace
Reaction Monitor List (1383) Print > Workplace
Requisition List (1388) Print > Workplace
Precision Check (1391) Print > Workplace
Reagent Reagent Load/Unload List (1393) Print > Reagent
Reagent Status (1397) Print > Reagent
Calibration Calibrator Load List (1400) Print > Calibration
Calibration Reaction Monitor List (1403) Print > Calibration
Calibration Trace (1407) Print > Calibration
Calibration Result List (1414) Print > Calibration
Calibration Request List (1416) Print > Calibration
QC QC Load List (1418) Print > QC
QC Request List (1420) Print > QC
Utility Alarm Trace (1422) Print > Utility
Communication Trace (1428) Print > Utility
Operator ID Trace (1430) Print > Utility
Cumulative Operation List (1432) Print > Utility
Application Parameters (1437) Print > Utility

Profile List (1439) Print > Utility
Rack Archival Report (1440) Print > Utility
Maintenance Report (1444) Print > Utility
Cuvette History (1448) Print > Utility
Rack Delivery Trace (1452) Print > Utility
Automatic Calibration reports Calibration Monitor report (ISE module) (1454) Automatically
Calibration Monitor report (photometric modules) (1456) Automatically
Calibration Monitor report (cobas e modules) (1459) Automatically
Automatic Maintenance Photometer Check report (1463) Utility > Maintenance
reports Cell Blank Measurement report (1464) Utility > Maintenance
Disk Check report (1466) Utility > Maintenance
ISE Check report (1468) Utility > Maintenance
Sample Barcode Reader Check report (1469) Utility > Maintenance
Reagent ID Reader Check report (1470) Utility > Maintenance
y Available reports
Roche Diagnostics
Workplace print window 1379
Workplace print window

f Print > Workplace
The Workplace print window displays a list of reports

relating to the Workplace menu. The window changes
depending on the report selected and whether the system
is in barcode mode or non-barcode mode.
Result List
f Print > Workplace > Result List

Prior to printing or viewing this report, select the desired
data on Workplace > Data Review.
Select Result List to print the measured data for the

selected samples.
Data Type area
Use this area to select the data type for printout.
1st Select this option to print the report for the first run
results.
Rerun Select this option to print the report for the rerun results.
Both Select this option to print the report for both the first run
and the rerun results.
Roche Diagnostics
1380 Workplace print window
Chosen Select this option to print the report for the chosen results.
In case two results are available for one test, it is possible
to mark the one which should be printed out. This can be
done in the Test Review window by choosing the box in the
first column of the first or second result.
u See Test Review window (1522).
Print Data area
Use this area to select the print data.
All Select this option to print all results, including edited

results.
Edited Select this option to print only the edited results.

Roche Diagnostics
Result List report
The Result List displays the measurement results of

samples selected on the Data Review submenu.
A B C D E F G
Operator ID: admin 2009/ 09/ 15 16:46

Dat a T ype: 1s t Print Data: A ll
S. Type Seq. No. Rack No. - Pos. Sample ID / Control Lot ID Pre-diluted Arrived Date/Time
Comment Operator ID
T es t A. U. Result Dil. Alarm Rg. St. R. P. Lot ID R. P. Seq. No.
Ser/Pl 50445-4 ID : 174 2009/06/24 14:45:07

Comment-001 : Jana
ALTL ( C2-B ) 71.7 ReagEx
ALTLP ( C2-B ) 81.7 ReagEx
ASTL ( C2-A ) 86.7 ReagEx
ASTLP ( C2-A ) 93.7 ReagEx
CA ( C2-A ) 1.40 ReagEx
CHO2A ( C2-B ) 2.98 ReagEx
CHO2I ( C2-A ) 2.94 ReagEx
CK ( C2-B ) 272 ReagEx
Cl ( I1 ) 70
GGTI2 ( C2-A ) 117 >Test
+ GGTI2 ( C2-A ) 118 >Test
GGTS2 ( C2-A ) 103
GLUC3 ( C2-B ) 7.87 ReagEx
H ( C2-B ) 0
I ( C2-B ) 2
K ( I1 ) 4
L ( C2-B ) 12

H I J K L M N O P Q R S
A S. Type H Comment O Rg. St.

B Seq. No. I Test P Reagent position
C Rack No. – Pos J A. U. Q Reagent timing
D Sample ID/Control Lot ID K Results R R. P. Lot ID
E Pre–diluted L Dil. S R. P. Seq. No.
F Arrived Date/Time M Alarm
G Operator ID N COI/RM
w Result List report
Field or column Explanation

A S. Type Type of sample material tested (for example, Ser/Pl, Urine, or CSF)
For controls, nothing is displayed.
B Seq. No. Sequence number of the sample
This information is specified on Workplace > Test Selection for instruments not using a
(non-barcode mode) sample barcode reader.
y Fields and columns in the Result List report
Roche Diagnostics

C Rack No. – Pos Rack number (first 5 digits) and position number (last digit) for the selected sample
Routine: RRRRR – P
STAT: S RRRRR – P
Rerun: R RRRRR – P
Quality Control: Q RRRRR – P
Calibrator: C RRRRR – P
D Sample ID/Control Lot ID Sample identification number
This number indicates the barcode number if the sample barcode reader is used, or manual
entry if the barcode reader is not used.
For controls, the lot number is displayed.
E Pre–diluted This field indicates whether a sample was pre-diluted or not.
Pre – diluted Sample was pre-diluted
F Arrived Date/Time Date and time when the sample was registered by the system
G Operator ID Operator ID of the operator logged on when the sample was measured.
H Comment Main comment title and text entered on the Sample Information window.
Comment Titles window (1701)
Sample Information window (1499)
I Test The short names of the tests are displayed.
+ Indicates that this is a rerun result.
J A. U. Short name of the module (analytical unit) and reagent disk or measuring cell on which the
test was performed.
K Results Results for the selected sample
L Dil. Used dilution ratio (if applicable)
It is only displayed if the Print Dilution Ratio check box is selected on the Print Settings
window.
Inc The test was run with an increased sample volume.
Dec The test was run with a decreased sample volume.
x The test was run with a diluted sample volume. The number (x)
displays the dilution ratio selected in the Workplace > Test
Selection submenu.
M Alarm This column displays the existing data alarms for each test.
N COI/RM The cutoff value for qualitative assays on cobas e modules.
OR:
The result message for quantitative assay on cobas e modules.
O Rg. St. The reagent status (current or standby) of the reagent cassette is displayed to the right of
the Alarm column.
P Reagent position Position of the reagent cassette in the module (for example, A–23)
Q Reagent timing The reagent timing R1, R2, R3 (only for c 701/c 702).
R R. P. Lot ID Lot number of the reagent cassette
S R. P. Seq. No. Sequence number of the reagent cassette
y Fields and columns in the Result List report
Roche Diagnostics
Reaction Monitor List

f Print > Workplace > Reaction Monitor List

Select Reaction Monitor List in the report list to print the

Reaction Monitor List report for the selected samples.
Data Type area

Use this area to select the data type for printout.
1st Select the 1st option to print the report for the first run
results.
Rerun Select the Rerun option to print the report for rerun
results.
Roche Diagnostics
Wavelength area
Use this area to select the wavelength for printout.
Primary, Secondary Use this option to print the primary and secondary
wavelength data.
(Primary) - (Secondary) Use this option to print the difference of the primary
wavelength data minus the secondary wavelength data.
Test area
Select the desired test for the report from the list box.
Roche Diagnostics
Reaction Monitor List report
The Reaction Monitor List displays information about the

reaction process.
A B C D E F G H I J K

Data Type: 1st
50445-4 ID : 174 Ser/Pl C2-B Cell : 274
2009/06/24 14:50:52 GLUC3 7.87 ReagEx
Chart ( Primary - Secondary )
10000
8000
6000
4000
2000
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38
Primary
CB1-4 1-10 11-20 21-30 31-40 41-50 51-60 61-70

14492 1384 1273 4634 6197
14471 1345 1276 5760 6200
14483 1300 1268 6073 6198
1285 1275 6165 6196
1281 1276 6193 6199
1274 1272 6196 6194
1273 1274 6196 6200
1269 1272 6199 6198
1273 1275 6197
1274 1860 6197
Secondary
CB1-4 1-10 11-20 21-30 31-40 41-50 51-60 61-70
9687 4 -2 -2 -8
9684 12 1 3 -6
A Seq. No. E Test I S. Type

B Rack No. – Pos. F Result J Module
C ID number/Control Lot ID G Alarm K Cell
D Date/Time H Prozone Value L Absorbance values
w Reaction Monitor List report– c 701/c 702 monochromatic measurement
Roche Diagnostics
A B C D E F G H I J K

Data Type: 1st
50445-4 ID : 174 Ser/Pl C2-B Cell : 274
2009/06/24 14:50:52 GLUC3 7.87 ReagEx
10000
8000
6000
4000
2000
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38
Primary - Secondary
CB1-4 1-10 11-20 21-30 31-40 41-50 51-60 61-70
4805 1380 1275 4636 6205
4787 1333 1275 5757 6206
4800 1298 1273 6081 6205
1284 1279 6173 6203
A Seq. No. E Test I S. Type

B Rack No. – Pos. F Result J Module
C ID number/Control Lot ID G Alarm K Cell
D Date/Time H Prozone Value L Absorbance values
w Reaction Monitor List report – c 701/c 702 bichromatic measurement
Field Explanation
A Seq. No. Sequence number of the sample
(non-barcode mode) This information is specified on Workplace > Test Selection for instruments not using a
sample barcode reader.
B Rack No. – Pos. Rack number (first 5 digits) and position number (last digit) for the selected sample
STAT: S RRRRR – P
C ID number/Control Lot ID Sample identification number
For controls, the lot number is displayed.
D Date/Time Date and time when the sample was pipetted
y Fields in the Reaction Monitor List report
Roche Diagnostics
Field Explanation
E Test Test name
F Result Calculated result
G Alarm If a data alarm exists, it appears to the right of the numeric result
H Prozone Value Prozone check value
I S. Type Type of sample material tested (for example, Ser/Pl, Urine, or CSF)
For controls, nothing is displayed
J Module Short name of the module and reagent disk on which the test was performed
K Cell The reaction cell that contained the chemical reaction whose results are displayed on
the report
L Absorbance values For the specified sample number, the absorbance values are printed, either primary,
secondary, or primary – secondary (bichromatic) wavelengths.
(Primary, Secondary, or The first line gives the cycle number during which the readings occurred.
Primary - Secondary) The first column contains the cell blank readings (CB1-4).
The other columns contain the reaction absorbance values obtained with each pass
through the photometer read window.
y Fields in the Reaction Monitor List report
Roche Diagnostics
Requisition List
f Print > Workplace > Requisition List

Select Requisition List from the report list to print the

Requisition List report for the specified samples.
Roche Diagnostics
Requisition List report
The Requisition List displays the tests and the kind of

sample volume required for the measurement.
A B C D E F
Operator ID: admin 2009/09/16 14:55

S. Type Seq. No. Rack No. - Pos. Sample ID Pre-dilution
S. Cup Comment-001
Test Dil.
Ser/Pl 50050-1 296
+ ALTL + AL T L P + AS T L P + C HO2A + CREJ 2

+ GGTI2 ( Dec ) + G L UC 3
Ser/Pl 50050-2 297
+ ALTLP + AS T L + CA + C HO2I + G G T I2
+ GGTS2
Ser/Pl 50050-3 298
+ ALTL + AL T L P + AS T L P + C HO2A + CREJ 2

+ GGTI2 ( Dec ) + G L UC 3
Ser/Pl 50050-4 299
+ ALTLP + AS T L + CA + C HO2I + G G T I2
+ GGTS2

G H I J
K L
Test Count
Test Count
ALTL 3 ALTLP 5 ASTL 2 ASTLP 3 CA 3
CHO2A 3 CHO2I 3 CREJ2 3 GGTI2 7 GGTS2 2
GLUC3 2
System Name: C8000 3 of 3
A S. Type E Pre-dilution I Test

B Seq. No. F Comment J Dil.
C Rack No. – Pos. G S.Cup K Test
D Sample ID H Rerun flag L Count
w Requisition List report
Roche Diagnostics
Field Explanation
A S. Type Type of sample material tested (for example, Ser/Pl, Urine, or CSF)
For controls, nothing is displayed.
B Seq. No. Sequence number of the sample
C Rack No. – Pos. Rack number (first 5 digits) and position number (last digit) for the selected sample
STAT: S RRRRR – P
D Sample ID Sample identification number
E Pre-dilution This field indicates whether a sample was pre-diluted or not.
Pre–diluted The sample was pre-diluted.
F Comment Main comment title and text entered on the Sample Information window.
G S.Cup This column displays if a micro cup was programmed for this sample.
Micro A micro cup was programmed
A standard cup was used
Note: Micro cups are not to be used on the e 602 module
H Rerun flag This field displays if the sample is selected for rerun.
+ The sample is selected for rerun.
(a plus)
I Test Test name requested for the specific sample
Tests are listed in the order selected in the Display Settings window.
J Dil. Used dilution ratio (if applicable)
It is only displayed if the Print Dilution Ratio check box is selected on the Print Settings
window.
Inc The test was run with an increased sample volume.
Dec The test was run with a decreased sample volume.
x The test was run with a diluted sample volume. The number
displays the dilution ratio selected in the Workplace > Test
Selection submenu.
y Fields in the Requisition List report
Test Count There are 2 columns in the Test Count area that list the test
name and a count.
Column Explanation
K Test Short test name
L Count Cumulative number of times each test is requested for the range of samples included in
the printout.
y Columns in the Test Count area
Roche Diagnostics
Precision Check
f Print > Workplace > Precision Check

Select Precision Check from the report list to print the

Precision Check report for the selected samples. This
report can be used to troubleshoot application problems
or verify precision, particularly after performing
maintenance.

Module Select the desired module(s) for the precision check
report.
Comment Type a comment with up to 80 characters.
Roche Diagnostics
Precision Check report
The Precision Check displays information about statistical

items for each test.
A B

Comment:
Module C4-A
Test N Mean Unit Range Max MiN SD CV(%)
FERR3 00107 31.85 μg/L 8.9 36.6 27.7 1.38 4.34
H 00025 0.0 0 0 0 0.0
I 00025 3.0 0 0 0 0.0 0.00
IGA-2 00107 0.776 g/L 0.13 0.86 0.73 0.033 4.21
IGG-2 00107 3.916 g/L 0.45 4.18 3.73 0.116 2.95
IGM-2 00107 0.401 g/L 0.07 0.44 0.37 0.019 4.83
L 00025 11.5 8 15 7 2.0 17.02
MG2 00107 1.033 mmol/L 0.12 1.09 0.98 0.032 3.10
PHOS2 00107 1.229 mmol/L 0.12 1.29 1.17 0.031 2.55
UA2 00107 6.54 mg/dL 0.6 6.9 6.3 0.16 2.49
C D E F G H I J K
A Comment E Mean I Min

B Module F Unit J SD
C Test G Range K CV(%)
D N H Max
w Precision Check report


A Comment The comments entered on the Precision Check print window appear just below the report
title.
If no comment is entered on the Precision Check print window, nothing is printed here.
B Module Short name of the module and reagent disk on which the test was performed
C Test Test names included in the specified range of samples
D N Number of results included in the calculation for the corresponding test
E Mean Calculated mean for each test
F Unit Measurement unit for each test
G Range Difference between the highest and lowest results for each test
H Max Maximum value for each test
I Min Minimum value for each test
J SD Calculated standard deviation for each test
K CV(%) Calculated percent coefficient of variation (CV) for each test
y Fields and columns in the Precision Check report
Roche Diagnostics
Reagent print window 1393
Reagent print window

f Print > Reagent
The Reagent print window displays a list of reports relating

to the Reagent menu. The window changes depending on
the selected report.
Reagent Load/Unload List

f Print > Reagent > Reagent Load/Unload List

Select Reagent Load/Unload List from the report list to
print a list that comprises all reagents that need to be
loaded and those that need to be removed from the
instrument.
Including Reagent Manager (c 702) Select this check box if the reagent cassettes present on
the buffer rotor should be taken into account when printing
the Reagent Load/Unload List.
Reagent Load/Unload List report
The Reagent Load/Unload List displays the reagents

loaded on the system including the number of remaining
tests, any applicable alarm (purple, yellow or red), and any
mandatory reagents that are not loaded. In addition, the
reagents currently loaded on the system that are not
available for further tests and therefore need to be
unloaded are displayed.
Roche Diagnostics
1394 Reagent print window
A B C D E F G H
C I G J K L M N
Reagent Unload List

Pos. Test Reason Type
A- 1 ALB2 R 1- R 2
A- 2 TP2 R 1- R 2
A- 3 IRON2 R 1- R 3
A- 4 PHOS2 R 1- R 2
A-5 ALTL Yellow R1-R2
A-6 CHO2A Yellow R1

A- 6 CHO2I R1
A- 7 GGTI2 R 1- R 2
A- 7 GGTS2 R 1- R 2
A- 8 UREAL R 1- R 2
K C I J
A Module F R. Disk K Pos.

B Including Reagent Manager G Available Tests L Remaining
C Test H Initial Loading Limit M Lot ID
D R. Pack I Reason N Exp. Date
E Ratio J Type
w Reagent Load/Unload List report
The Reagent Initial Load List at the top of the report shows
the ratio of the remaining number of tests to the set Initial
Loading Limit.
Roche Diagnostics
Example: GLUC3 on reagent disk A (see figure above):

The Initial Loading Limit was set to 5000 tests and
4318 tests are currently available at the time of printing
the report, so the ratio is 86%. The 4318 tests consist of
two reagent cassettes: 2122 tests on disk position A-6 and
2196 on A-10.
• If an additional GLUC3 reagent cassette were available
on the buffer rotor, GLUC3 would not have been listed
in the Reagent Initial Load List area of the report. The
amount of reagent in the buffer rotor would be added.
• If the Including Reagent Manager check box were not
selected, the result would have been the same as
shown in the figure (4318 tests, 86%), even if a GLUC3
pack was on the buffer rotor.

A Module Short name of the module on which the test is performed
B Including Reagent Manager If Including Reagent Manager is displayed on the report, the reagent cassettes on the
buffer rotor are taken into account when calculating the remaining amount of reagent.
C Test Name of a test, detergent, or diluent
D R. Pack Number of reagent cassettes that have to be loaded on the reagent disk for the days
work.
E Ratio The ratio of the number of currently available tests to the set Initial Loading Limit defined
on Utility > System > Reagent Loading Level. The percentage value shows how much
reagent is available in relation to the daily workload.
F R. Disk The reagent disk containing the reagent cassette.
G Available Tests Total number of tests remaining in the reagent cassette or the total number of mL
remaining for special reagent, diluent, or detergent.
H Initial Loading Limit Displays the Initial Loading Limit defined on Utility > System > Reagent Loading Level.
I Reason The reason (for example, an alarm about remaining volume), why a reagent has to be
loaded.

Mandatory A mandatory reagent is missing on the module.
Expired The onboard stability time or the expiry date have been
exceeded.
Purple The remaining volume is lower than the purple reagent level
check value.
Yellow The remaining volume is lower than the yellow reagent level
check value.
Red The remaining volume is 0. Also used if all reagent cassettes
for a test are masked.
Red (Dil) The solution for the dilution of an immunity test is missing.
Red (Pre) The pretreatment reagent for an immunity test is missing.
Only one reason for a test can be displayed. It is displayed in the following priority:
Mandatory > Red > Expired > Yellow > Purple.
Purple is only displayed if the Preventive Action check box on the Overview menu is
selected.
J Type Type of the reagent (for example R1, DIL, SPR, or ECO-D)
K Pos. Position of the reagent on the reagent disk
L Remaining Number of remaining tests in the corresponding reagent cassette or the number of mL
remaining for ISE reagent, special reagent, diluent, or detergent in the corresponding
reagent container
y Fields and columns in the Reagent Load/Unload List report
Roche Diagnostics

M Lot ID Lot number of the reagent cassette
N Exp. Date Two expiry dates are displayed:
o The first one: expiry date of the reagent cassette in the corresponding position.
o The second one (number in parentheses): onboard stability time of the reagent (in
days).
y Fields and columns in the Reagent Load/Unload List report
Roche Diagnostics
Reagent Status
f Print > Reagent > Reagent Status
Select Reagent Status from the report list to print a list that
comprises all reagents and their status for the various
instrument modules including system reagents.
Including Reagent Manager (c 702) Select this check box if the reagent cassettes present on
the buffer rotor should be taken into account when printing
the report.
Roche Diagnostics
Reagent Status report
The Reagent Status displays the reagent and the inventory

information for each reagent on the system including the
number of remaining tests and any applicable alarm
(purple, yellow or red).
A B

Module C1
Test Reason Available Tests Type Pos. Remaining Lot ID Exp. Date
AL T L 1686 R1-R3 A-1 852 613095 2010/08 (0)
AL T L P 1686 R1-R3 A-1 852 613095 2010/08 (0)
CREJ 2 2390 R1-R3 A-2 1231 612853 2011/02 (0)
C R J 2U 2390 R1-R3 A-2 1231 612853 2011/02 (0)
G G T I2 1886 R1-R3 A-3 942 611554 2009/12 (0)
GGT S 2 1886 R1-R3 A-3 942 611554 2009/12 (107)
IG G - 2 663 R1-R3 A-4 34 613152 2010/ 10 (0)
IG G - 2 663 R1-R3 A-5 316 613152 2010/10 (0)
L DHI2 1492 R1-R3 A-6 746 612856 2010/05 (0)
CK 1342 R1-R3 A-7 665 612902 2010/05 (0)
AS T L 1460 R1-R3 A-8 723 607616 2010/03 (0)
AS T L P 1460 R1-R3 A-8 723 607616 2010/03 (0)
C HO2A 2608 R1-R1 A-9 29 605568 2009/ 09 (0)
C HO2I 2608 R1-R1 A-9 29 605568 2009/ 09 (0)
C HO2A 2608 R1-R1 A-10 1264 605568 2009/09 (0)
C HO2I 2608 R1-R1 A-10 1264 605568 2009/09 (0)
A-11 178 605575 2009/12 (0)
C D E F G H I J
A Module E Available Tests I Lot ID

B Including Reagent Manager F Type J Exp. Date
C Test G Pos.
D Reason H Remaining
w Reagent Status report

A Module Short name of the module that contains the reagent
B Including Reagent Manager If Including Reagent Manager is displayed in the report, the number of tests or the volume
available were added to the total number of tests or total volume available on the
corresponding c 702 module.
C Test Name of a test, detergent, or diluent
y Fields and columns in the Reagent Status report
Roche Diagnostics

D Reason Alarm about remaining volume
Expired The onboard stability has expired or the expiry date has been
exceeded.
Purple The remaining volume is lower than the purple reagent level
check value.
Yellow The remaining volume is lower than the yellow reagent level
check value.
Red The remaining volume is 0.
Purple is only displayed if the Preventive Action check box on the Overview menu is
selected.
E Available Tests Total number of remaining tests in the reagent cassette or the total number of mL
remaining for special reagent, diluent, or detergent
F Type Type of the reagent (for example R1, DIL, SPR, or ECO-D)
G Pos. Position of the reagent on the reagent disk
H Remaining Number of remaining tests in the corresponding reagent cassette or the number of mL
remaining for ISE reagent, special reagent, diluent, or detergent in the corresponding
reagent container
* The number of remaining tests number is 0 or the remaining
(asterisk) volume is less than 1 mL.
I Lot ID Lot number of the reagent cassette
J Exp. Date Two expiry dates are displayed:
o The first one: expiry date of the reagent cassette in the corresponding position.
o The second one (number in parentheses): onboard stability of the reagent (in days). 0
indicates that the onboard stability has been exceeded.
y Fields and columns in the Reagent Status report
Roche Diagnostics
1400 Calibration print window
Calibration print window

f Print > Calibration
The Calibration print window displays a list of reports

relating to the Calibration menu. The window changes with
the selected report.
Calibrator Load List

f Print > Calibration > Calibrator Load List
Select Calibrator Load List from the report list to print a

detailed list of the location for required standards.
Roche Diagnostics
Calibration print window 1401
Calibrator Load List report
The Calibrator Load List displays a detailed description of

where to place standards on the rack.
A B

Module Specific Rack
Module Rack Range
C1 C20004 - C20004
C2 C20005 - C20005
C3 C20006 - C20006
C4 C20007 - C20007
ISE -
Calibrators
Calibrator Code Lot ID Rack No. - Pos. Event
C F AS 00401 181260 C 20003- 2 18
C20004-2
C20005-2
C20006-2
C20007-2
H2O 00901 999999 C 20003- 1 38
C20004-1
C20005-1
C20006-1
C20007-1

C D E F G H
A Module D Code G Event

B Rack Range E Lot ID H Volume
C Calibrator F Rack No. – Pos.
w Calibrator Load List report
Module Specific Rack area This area provides details specific to the individual
modules.
Column Explanation
A Module Short name of the module on which the calibrator is located
B Rack Range Rack range for the corresponding module defined on Utility > System > Rack Assignment
> Module Settings.
u See Module Settings tab (1684).
y Columns in the Module Specific Rack area
Roche Diagnostics
Calibrators area This area provides details specific to the individual

calibrators.
Column Explanation
C Calibrator Name of each calibrator.
For cobas e modules, the calibrator level (for example, T4-L2 for an immunology test
name T4, calibrator level 2) is displayed to the right of the calibrator name.
D Code Code of the calibrator
E Lot ID Lot number of each calibrator
F Rack No. – Pos. Assigned position of each standard on the calibrator racks
G Event Number of times a calibrator will be sampled.
H Volume Volume of calibrator required
This element is displayed only for immune tests.
y Columns in the Calibrators area
Roche Diagnostics
Calibration Reaction Monitor List

f Print > Calibration > Calibration Reaction Monitor List

data on Calibration > Status.
Select Calibration Reaction Monitor List in the report list to

print the Calibration Reaction Monitor List report for the
selected calibrations.

Std. area
Use these two list boxes to specify a standard range to be

printed. Select Std (1) through Std (6) from the first list box
and press the Enter key. Select Std (1) through Std (6) from
the second list box and press Enter.
Abs. Data area
Use this area to select the absorbance data for printout.
1st Select the 1st option to print the first result for the
standard(s) selected.
2nd Select the 2nd option to print the second or duplicate

result for the standard(s) selected.
Both Select the Both option to print first and duplicate

Roche Diagnostics
Wavelength area
Use this area to select the wavelength for printout.
Primary, Secondary Use this option to print the absorbance data for the
primary and secondary wavelengths.
(Primary) - (Secondary) Use this option to print only the bichromatic readings.
Calibration Reaction Monitor List report
The Calibration Reaction Monitor List displays information

about the calibration reaction process.
A B C D E F G H I

Std(1) 1st 999999 C3-A Cell : 93 GLUC3 64.00
2000
1600
1200
800
400
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38
Primary - Secondary
CB1-4 1-10 11-20 21-30 31-40 41-50 51-60 61-70
14586 1127 1028 924 936
14601 1064 1032 932 934
14590 1057 1034 932 938
1044 1030 935 937
1035 1032 933 934
1036 1031 935 934
938
A Std No. E Cell H Alarm

B Calib count F Test I Prozone Value
C Lot No. G Result J Absorbance values
D Module
w Calibration Reaction Monitor List report – bichromatic measurement
Roche Diagnostics
A B C D E F G H I

Std(1) 1st 999999 C3-A Cell : 93 GLUC3 64.00
2000
1600
1200
800
400
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38
Primary
CB1-4 1-10 11-20 21-30 31-40 41-50 51-60 61-70
14586 1119 1014 911 924
14601 1066 1020 921 921
14590 1047 1020 920 924
1037 1018 927 927
1026 1020 921 921
1025 1018 922 921
1020 1017 921 926
1025 1018 924 926

1015 1016 921
1025 901 925
Secondary
CB1-4 1-10 11-20 21-30 31-40 41-50 51-60 61-70
9677 -8 - 14 - 13 - 12
9671 2 -12 -11 -13
-14
A Std No. E Cell H Alarm

B Calib count F Test I Prozone Value
C Lot No. G Result J Absorbance values
D Module
w Calibration Reaction Monitor List report - monochromatic measurement
Field Explanation
A Std No. The standard – Std (1) to Std (6) is displayed
B Calib count Number of times a standard is measured (1st and 2nd)
C Lot No. Lot number of the calibrator
D Module Short name of the module and reagent disk on which the test was performed
y Fields in the Calibration Reaction Monitor List report
Roche Diagnostics
Field Explanation
E Cell The reaction cell that contained the chemical reaction whose results are displayed on
the report
F Test Test name
G Result Calculated result
H Alarm If a data alarm exists, it appears to the right of the numeric result
I Prozone Value Prozone check value
J Absorbance values For the specified sample number, the absorbance values are printed, either primary,
secondary, or primary – secondary (bichromatic) wavelengths.
(Primary, Secondary, or The first line gives the cycle number during which the readings occurred.
Primary - Secondary) The first column contains the cell blank readings (CB1-4).
The other columns contain the reaction absorbance values obtained with each pass
through the photometer read window.
y Fields in the Calibration Reaction Monitor List report
Roche Diagnostics
Calibration Trace
f Print > Calibration > Calibration Trace

data on Calibration > Status.
Select Calibration Trace from the report list to print the

Calibration Trace report for all calibrators.
Data Selection area

Use this area to select the data for printout.
All Select this option to print a Calibration Trace report for all
dates.
Range Select the Range option to print the report for a range of
dates. If selected, the Start and End date text boxes are
activated. The date format (dd/mm/yy, mm/dd/yy,
yy/dd/mm, or yy/mm/dd) is defined on Utility > System
> Display Settings.
u See Display Settings window (1702).
Date Range area
Use this area to enter the date range for printout.
Start Enter the first date of the date range to be printed on the
report.
Roche Diagnostics
End Enter the last date of the date range to be printed on the
report.
Calibration Trace report (ISE module)
The Calibration Trace displays the absorbance values of

the 50 most recent calibrations for a specific test.
A B

Na Module I1- A
200 100
160 80
120 60
80 40
40 20
0 0
1 2 3 4
Compensator Slope Result
Date Time Compensator Slope

Operator ID Conc. Lot ID Result High Lot ID Low Lot ID
2009/05/29 15:19 142 152250 56.8 607084 601878
admin Cal.E Cal.E
2009/05/29 16:41 142 152250 56.8 607084 601878
admin
2009/05/29 17:56 141 152250 56.0 607084 601878
admin
C D E F G H I J
A Test E Operator ID I High Lot ID (Slope)

B Module F Conc. (Compensator) J Low Lot ID (Slope)
C Date G Lot ID (Compensator)
D Time H Result (Slope)
w Calibration Trace report – ISE module

A Test The short test name is printed below the report name
y Fields and columns in the Calibration Trace report – ISE module
Roche Diagnostics

C Date The date (as defined on Utility > System > Display Settings) the calibration was performed
D Time The time (hh:mm) the calibration was performed
E Operator ID Operator ID of the operator logged on when the calibration was performed
F Conc. (Compensator) Concentration results
The results are printed in mmol/L. The number of decimal places is displayed as defined
If a data alarm for the compensator (ISE Standard High, used as calibrator 3) is issued
during calibration, it is displayed below the concentration results
G Lot ID (Compensator) Lot number of the ISE Standard High, used as calibrator 3
H Result (Slope) Slope results
If a data alarm for the slope is issued during calibration, it is displayed below the slope
result
I High Lot ID (Slope) Lot number of the aqueous High ISE standard
J Low Lot ID (Slope) Lot number of the aqueous Low ISE standard
Comment Comments entered on the Comment window in Calibration > Status > Calibration Trace are
printed at the bottom of the report
y Fields and columns in the Calibration Trace report – ISE module
Roche Diagnostics
Calibration Trace report (photometric modules)

A B

GGTI2
GGTI2 Module C2-B C2-B
STD 1 Result STD N Result
Date Time STD 1 STD 2-6 R. Pack

Operator ID Result Lot ID Result Lot ID Lot ID Seq. No.
09/09/2009 13:18 2588 999999 144 181445 R1 611554 0000007
admin Cal.E Cal.E R3 611554 0000007

09/09/2009 13:18 2246 999999 143 181445 R1 611554 0009438*
admin Cal.E Cal.E R3 611554 0009438*
15/09/2009 13:40 2586 999999 143 181445 R1 611554 0000007*
admin R3 611554 0000007*
15/09/2009 13:40 2588 999999 143 181445 R1 611554 0009438*
admin R3 611554 0009438*
17/09/2009 15:47 2597 999999 143 181445 R1 611554 0000007*
admin R3 611554 0000007*
17/09/2009 15:47 2264 999999 143 181445 R1 611554 0009438*
admin R3 611554 0009438*
145 181260 R1 611554 0000007*
C D E F G F G H I J
A Test E Operator ID I Lot ID (R. Pack)

B Module F Result J Seq. No. (R. Pack)
C Date G Lot ID
D Time H Type (R. Pack)
w Calibration Trace report – cobas c modules
Roche Diagnostics

F Result Absorbance (x 10⁴) results for Std 1 and Std 2 to 6 are listed here. The absorbance of the
highest standard is printed for nonlinear tests.
(STD 1 or STD 2–6) In case of a rate assay, it indicates the primary wavelength absorbance at photometric
measuring point 1 of Std (1).
If a data alarm for the standard is issued during calibration, it is displayed below the
absorbance results
* (asterisk) Another calibration method than the recommended method
was performed. Example: A full calibration is recommended
and a 2-point calibration was performed
G Lot ID Lot number of the standard (Std 1 or Std 2 to 6)
(STD 1 or STD 2–6)

H Type (R. Pack) Reagent type R1, R2, or R3
I Lot ID (R. Pack) Lot number of the reagent cassette that was used for calibration
* (asterisk) The Lot ID is different from the Lot ID with which the previous
data is measured
J Seq. No. (R. Pack) Sequence number of the reagent cassette that was used for calibration
* (asterisk) A reagent cassette changeover
printed at the bottom of the report
y Fields and columns in the Calibration Trace report – cobas c modules
Roche Diagnostics
Calibration Trace report (cobas e modules)

A B

PROG Module A3-1
200000 5000
160000 4000
120000 3000
80000 2000
40000 1000
0 0
1 2 3
MIN Result MAX Result
Date Time Calib. Lot ID S ignal R . P ac k

Operator ID Min Max Lot ID Seq. No.
01/12/2009 16:30 156088 169856 4700 15609000 000002
admin
02/12/2009 12:46 156088 167545 4316 15609000 000002
admin
02/12/2009 12:48 156088 145348 4026 15609000 000004*
C D E F G H I J
A Test E Operator ID I Lot ID (R. Pack)

B Module F Calib. Lot ID J Seq. No. (R. Pack)
C Date G Min (Signal)
D Time H Max (Signal)
w Calibration Trace report – cobas e modules

B Module Short name of the module and measuring channel on which the test was performed
y Fields and columns in the Calibration Trace report – cobas e modules
Roche Diagnostics

F Calib. Lot ID Lot number of the calibrator
G Min (Signal) Measured signal for the calibrator minimum level
The number of decimal places is displayed as defined on Utility > Application > Range.
If a data alarm is issued during the duplicate measurement of the calibrator it is displayed
below the signal.
* (asterisk) A data alarm is issued during the duplicate measurement of the
calibrator.
H Max (Signal) Measured signal for the calibrator maximum level
The number of decimal places is displayed as defined on Utility > Application > Range.
If a data alarm is issued during the duplicate measurement of the calibrator it is displayed
below the signal.
* (asterisk) A data alarm is issued during the duplicate measurement of the
calibrator.
I Lot ID (R. Pack) Lot number of the reagent cassette that was used for calibration
* (asterisk) The Lot ID is different from that which the previous data is
measured with.
J Seq. No. (R. Pack) Sequence number of the reagent cassette that was used for calibration
* (asterisk) A reagent cassette changeover
printed at the bottom of the report.
y Fields and columns in the Calibration Trace report – cobas e modules
Roche Diagnostics
Calibration Result List

f Print > Calibration > Calibration Result List
Select Calibration Result List from the report list to print a

detailed list of calibration results for photometric tests. No
criteria need to be selected in order to print this report.
Roche Diagnostics
Calibration Result List report
The Calibration Result List displays the results of the most

recent calibrations measured.

Module C1-A
Test S1 Abs. K A B C L H I
ALTL 5 -24477
ALTLP 6 -28868
ASTL 7 -24460
ASTLP 5 -30205
CA 352 2331
CHO2A 1593 1058
CHO2A 1638 1062
CHO2I 1586 1063
CHO2I 1630 1072
CK 3 6265
CREJ2 1 15489
CRJ2U 1 350211
GGTI2 3 7721
GGTS2 2 6259
GLUC3 47 1593
IGG-2 59 5.223E+1 1.031E+0 2.669E+4
IGG-2 57 5.724E+1 1.023E+0 2.722E+4
LDHI2 7 6423
LIPC 10 16774
SI2 5 10000 1 0 -1

B C D E F G H I J
A Module E A H L
B Test F B I H
C S1Abs. G C J I
D K
w Calibration Result List report

A Module Short name of the module and reagent disk on which the calibration was performed
B Test Short test name for the application
C S1Abs. Absorbance (x 10⁴) of standard (1)
For the calibration type spline or line graph, this column displays the absorbance (x 10⁴)
of Std (n) (n = 1–6).
D K Reciprocal of the calibration slope (K-factor)
For the calibration type spline or line graph, this column displays the result of K (n)
(n = 1–5).
E A Result of the nonlinear coefficient A (slope)
F B Result of the nonlinear coefficient B (intercept)
G C Result of the nonlinear coefficient C (cubic spline exponential)
H L Bichromatic absorbance difference of the lipemic index
y Fields and columns in the Calibration Result List report
Roche Diagnostics

I H Bichromatic absorbance difference of the hemolysis index
J I Bichromatic absorbance difference of the icterus index
y Fields and columns in the Calibration Result List report
Calibration Request List

f Print > Calibration > Calibration Request List
Select Calibration Request List from the report list to print

a detailed list of reagent cassettes selected for
calibration. No criteria need to be selected in order to print
this report.
Roche Diagnostics
Calibration Request List report
The Calibration Request List gives a description of

requested calibrations.
A B C D E F

Module C1-A
Test R. Pack Lot ID R. Pack Seq. No. Method
CA R1 605589 0000116 2Point
R3 605589 0000116
CHO2A R1 605568 0000114 Blank
CHO2A R1 605568 0000106 Blank
CHO2I R1 605568 0000114 Blank
CHO2I R1 605568 0000106 Blank
CREJ2 R1 612853 0000025 2Point
R3 612853 0000025
CRJ2U R1 612853 0000025 2Point
R3 612853 0000025
Module C1-B
Test R. Pack Lot ID R. Pack Seq. No. Method
CA R1 605589 0000104 2Point
R3 605589 0000104
CHO2A R1 605568 0000101 Blank
CHO2A R1 605568 0000107 Blank
CHO2I R1 605568 0000101 Blank
CHO2I R1 605568 0000107 Blank
CREJ2 R1 612853 0000026 2Point
R3 612853 0000026
CRJ2U R1 612853 0000026 2Point

R3 612853 0000026
A Module C Type E R. Pack Seq. No.

B Test D R. Pack Lot ID F Method
w Calibration Request List report

A Module Short name of the module and reagent disk on which the calibration was performed
For the ISE module, ISE1 or ISE2 is displayed.
C Type Reagent type R1, R2 or R3.
D R. Pack Lot ID Lot number of the reagent cassette that was used for calibration
E R. Pack Seq. No. Sequence number of the reagent cassette that was used for calibration
F Method For ISE and photometric calibrations, the different calibration methods are displayed.
For immunoassay calibrations, this column displays the order in which the measuring
channels are calibrated. CH1 CH2, for example, means channel 1 followed by channel 2.
y Fields and columns in the Calibration Request List report
Roche Diagnostics
1418 QC print window
QC print window
f Print > QC
The QC print window displays a list of reports relating to

the QC menu. The window changes with the selected
report.
QC Load List
f Print > QC > QC Load List
Select this item from the report list to print the QC Load
List. If Routine QC Test Selection is enabled and nothing is
selected on the QC > Status submenu, default QC controls
are printed on the QC Load List report.
Roche Diagnostics
QC Load List report
The QC Load List displays information about requested

measurements for each control and all QC after calibration
measurement requests. It also provides details specific to
individual modules.
A B C
䣑䣲䣧䣴䣣䣶䣱䣴䢢䣋䣆䢼䣣䣦䣯䣫䣰䢳䢷䢱䢲䢷䢱䢴䢲䢳䢹䢲䢷䢼䢷䢷
䣃䣷䣶䣱䣯䣣䣶䣫䣥䢢䣓䣅䢢䣔䣣䣥䣭䣓䢵䢲䢲䢲䢷䢯䣓䢵䢲䢲䢲䢷
䣏䣱䣦䣷䣮䣧䢢䣕䣲䣧䣥䣫䣨䣫䣥䢢䣔䣣䣥䣭
䣏䣱䣦䣷䣮䣧䣔䣣䣥䣭䢢䣔䣣䣰䣩䣧
䣥䢷䢯
䣧䢺䢯
䣋䣕䣇䢯
䣕䣻䣵䣶䣧䣯䢢䣓䣅
䣅䣱䣰䣶䣴䣱䣮䣕䢰䢢䣖䣻䣲䣧䣏䣣䣶䣧䣴䣫䣣䣮䢢䣐䣱䢰䣎䣱䣶䢢䣋䣆䣔䣣䣥䣭䢢䣐䣱䢰䢢䢯䢢䣒䣱䣵䢰䣇䣸䣧䣰䣶䣘䣱䣮䣷䣯䣧
䣒䣐䣗䣕䣧䣴䢱䣒䣮䢲䢲䢵䢲䢲䢳䢺䢸䢶䢵䢸䣓䢵䢲䢲䢲䢴䢯䢳䢳䢳䢷䢲
䣒䣒䣗䣕䣧䣴䢱䣒䣮䢲䢲䢵䢲䢳䢳䢹䢸䢵䢹䢳䢳䢳䢶䢵
䣒䣅䢢䣗䢳䣕䣧䣴䢱䣒䣮䢲䢲䢲䢲䢳䢳䢺䢸䢴䢸䢴䣓䢵䢲䢲䢲䢷䢯䢳䢷䢹䢺
䣒䣅䢢䣗䢴䣕䣧䣴䢱䣒䣮䢲䢲䢲䢲䢴䢳䢺䢸䢴䢸䢷䣓䢵䢲䢲䢲䢷䢯䢴䢶䢹䢴
䣒䣅䢢䣖䣐䢳䣕䣧䣴䢱䣒䣮䢲䢲䢲䢶䢷䢳䢺䢸䢷䢲䢵䣓䢵䢲䢲䢲䢳䢯䢳䢺䢴䢶䢲
䣒䣅䢢䣖䣐䢴䣕䣧䣴䢱䣒䣮䢲䢲䢲䢶䢸䢳䢺䢸䢷䢲䢶䣓䢵䢲䢲䢲䢳䢯䢴䢺䢴䢶䢲
䣓䣅䢢䣖䣕䣊䢳䣕䣧䣴䢱䣒䣮䢴䢷䢷䢷䢷䢳䢴䢵䢶䢷䢸䢴䢸䢲
䣓䣅䢢䣖䣕䣊䢴䣕䣧䣴䢱䣒䣮䢴䢷䢸䢸䢸䢴䢵䢶䢷䢸䢹䢴䢸䢲

D E F G H I J
A Automatic QC Rack E S. Type H Rack No. – Pos.

B Module F Material No. I Event
C Rack Range G Lot ID J Volume
D Control
w QC Load List report
Automatic QC Rack This area provides details about the automatic QC rack
range.
Field Explanation
A Automatic QC Rack Rack range for auto. QC racks defined on Utility > System > Rack Assignment > Module
Settings.
y Field in the Automatic QC Rack area
Roche Diagnostics
1420 QC print window
Module Specific Rack This area provides details specific to the individual
modules.
Column Explanation
B Module Short name of the module on which the control is located
C Rack Range Rack range for the corresponding module defined on Utility > System > Rack Assignment
> Module Settings.
u See Module Settings tab (1684)
y Columns in the Module Specific Rack area
System QC This list displays the controls and corresponding

information needed to perform the requested QC
measurements.
Column Explanation
D Control Name of each control
E S. Type Sample type of the control
F Material No. Code number of the control
G Lot ID Lot number of each control
H Rack No. – Pos. Assigned position of each control on the QC rack
I Event Number of times a control will be sampled
J Volume Volume of control material required
y Columns in the System QC area
QC Request List
f Print > QC > QC Request List
Select QC Request List from the report list to print a

detailed list of tests selected for QC. No criteria need to be
selected in order to print this report.
Roche Diagnostics
QC Request List report
The QC Request List displays information about the

requested measurement for each test.
A B C D E F
O perator ID: admin 2009/ 09/ 16 15:49

Module C1-A
Test Rg. St. Control Material No. Lot ID
ALTL Current PNU 00300 150403
ALTL Current PPU 00301 150415
Module C3-A
Module C4-A
Module I1
Cl PNU 00300 150403
Cl PPU 00301 150415
K PNU 00300 150403
00301 150415
A Module C Rg. St. E Material No.

B Test D Control F Lot ID

w QC Request List report

A Module Name of the module and reagent disk for which QC has been requested
C Rg. St. The status (current or standby) of the reagent cassette for which QC has been
requested.
D Control Name of each control
E Material No. Code number of the control
F Lot ID Lot number of the control for which QC has been requested
y Fields and columns in the QC Request List report
Roche Diagnostics
1422 Utility print window
Utility print window

f Print > Utility
The Utility print window displays a list of reports relating to

the Utility menu. The screen changes with the selected
report.
Alarm Trace
f Print > Utility > Alarm Trace
Select Alarm Trace from the report list to print or delete

the Daily or Cumulative alarm trace.
Alarm Trace area
Use this area to select Daily Alarm Trace or Cumulative

Alarm Trace.
Daily Select this option to print Daily Alarm Trace.
Cumulative Select this option to print Cumulative Alarm Trace.
Roche Diagnostics
Utility print window 1423
Data Selection area
All Select this option to print an Alarm Trace report for all
dates.
Date Range Select this option to print the report for a range of dates. If
selected, the Start and End date text boxes are activated.
The date format is defined on Utility > System > Display
Settings.
Start Enter the first date and time of the date range to be
printed on the report.
End Enter the last date and time of the date range to be printed
on the report.
Roche Diagnostics
Daily Alarm Trace report
The Daily Alarm Trace displays information about alarm,

retry, or event.
A B C D E F G
A Date and Time D Alarm (A), Retry (R), or Event (E) F Code
Information
B Status Code E Module G Data

C Count
w Daily Alarm Trace report
Column Explanation
A Date and Time The date (as defined on Utility > System > Display Settings) and time (hh:mm) when the
alarm occurred.
B Status Code Status code of the system when the alarm occurred
C Count Number of successive cycles during which each alarm occurred since Power On.
D Alarm (A), Retry (R), or Event The letter in the fifth column indicates the following:
(E) Information A Instrument alarm
R Retry code
Retry codes document system functions as monitored by the central
processing unit (CPU). Not all retry codes indicate an abnormality. Retry
codes are intended for service use only and are not listed in this manual.
E Event code
E Module Short name of the module on which the alarm occurred
y Columns in the Daily Alarm Trace report
Roche Diagnostics
Column Explanation
F Code The codes for alarm, retry, and event. The code can be composed of 3 parts:
Part 1 2 3
A Code for the major Code for the minor Code for the
(type) alarm (number) alarm occurrence time
within the time period
(cycle)
R Code for retry Code for the Code for the
occurrence time of occurrence time
retry generating within the time period
(cycle)
E Code for event Code for the Code for the
occurrence time of occurrence time
event generating within the time period
(cycle)
G Data The alarm message, retry name, or event name appears to the right of each code.
y Columns in the Daily Alarm Trace report
Roche Diagnostics
Cumulative Alarm Trace report
A B C
D E F G
A Date D Alarm (A), Retry (R), or Event (E) F Code

Information
B Power Up Time E Module G Data
C Last Alarm Time
w Cumulative Alarm Trace report
Column Explanation
A Date The date the instrument is powered up.
B Power Up Time The time (hh:mm) the instrument is powered up, as determined by the realtime clock.
--"-- : --"-- The instrument is permanently on
C Last Alarm Time The time (hh:mm) at which the last alarm occurred, as determined by the realtime clock.
y Columns in the Cumulative Alarm Trace report
Roche Diagnostics
Column Explanation
D Alarm (A), Retry (R), or Event The letter in the fourth column indicates the following:
(E) Information A Instrument alarm
R Retry code
Retry codes document system functions as monitored by the central
processing unit (CPU). Not all retry codes indicate an abnormality. Retry
codes are intended for service use only and are not listed in this manual.
E Event code
E Module Short name of the module on which the alarm occurred
F Code The codes for alarm, retry, and event. The code can be composed of 3 parts:
Part 1 2 3
A Code for the major Code for the minor Code for the
(type) alarm (number) alarm occurrence time
within the day
R Code for retry Code for the
occurrence time
within the day
E Code for event Code for the
occurrence time
within the day
G Data The alarm message, retry name, or event name appears to the right of each code.
y Columns in the Cumulative Alarm Trace report
Roche Diagnostics
Communication Trace
f Print > Utility > Communication Trace
Select this item from the report list to print or delete the
Communication Trace.
Data Selection area

Date Range Select this option to print or delete a report for a date
range. If selected, the Start and End date text boxes are
activated. The date format is defined on Utility > System
> Display Settings.
Detail Select this option to print or delete a report for detail

dates. If selected, the Start text boxes are activated. The
on the report.
Roche Diagnostics
Communication Trace report
The Communication Trace displays information about the

communication between the instrument and the data
manager.
A B C D E
A Date C Code E Data

B Time D Size
w Communication Trace report
Column Explanation
A Date Communication date (as defined on Utility > System > Display Settings)
B Time Communication time (hh:mm:ss:sss)
C Code Transceiver code:
S transmitting
R receiving
E alarm

D Size Size of data (Byte)
E Data The information (character string) from the transceiver.
In case of an alarm, an alarm code and alarm name are displayed.
y Columns in the Communication Trace report
For information concerning interpretation of this report,

contact technical support.
Roche Diagnostics
Operator ID Trace
f Print > Utility > Operator ID Trace
Select this item from the report list to print the Operator ID
Trace.
Data Selection area

All Select this option to print Operator ID Trace for all dates.
Date Range Select this option to print or delete a report for a range of
> Display Settings.
on the report.
Roche Diagnostics
Operator ID Trace report
The Operator ID Trace report indicates the dates and times

each operator has logged on to and off the system for the
specified date range.

Date Operator ID Logon Logoff Operator ID Logon Logoff
2009/05/27 admin 16:17 ** admin 16:29 **
John 16:42 ** Toni 17:16 **
2009/05/28 Marie 08:57 ** admin 13:48 **
John 14:08 ** Toni 14:21 **
2009/06/08 Toni 13:22 ** admin 14:36 14:39
oper 14:39 14:40 admin 14:40 17:43
A B C D
A Date C Logon
B Operator ID D Logoff
w Operator ID Trace report
Column Explanation
A Date Date of the logon activity
B Operator ID ID of the operator logged on to the system at the given date.
C Logon The time the operator logged on to the system.
D Logoff The time the operator logged off the system.
** For a logoff that occurs automatically by the system instead of
(a double asterisk) the operator logging off (for example, during a power loss).

-- For the operator logged on during printing this report
(a double dash)
y Columns in the Operator ID Trace report
Roche Diagnostics
Cumulative Operation List

f Print > Utility > Cumulative Operation List
Select this item from the report list to print the Cumulative
Operation List. No criteria need to be selected in order to
print this report.
Roche Diagnostics
Cumulative Operation List report
The Cumulative Operation List report gives the test count

of the number of each test performed by the system as
well as the power on time and the time in Operation.

D E F G H I J K
A Power On Time E Code I Calib.

B Operation Time F Routine J Control
C Module G Rerun K Total
D Test H STAT
w Cumulative Operation List report – Test Count
Field Explanation
A Power On Time The total time (hours) the system was powered on. This includes Standby and Operation.
B Operation Time The total time (hours) the system has been in Operation.
y Fields in the Cumulative Operation List report
Roche Diagnostics
Test Count This table includes the test count of routine, rerun, STAT,
calibrator, and control samples for each module in order of
application code.

C Module Short name of the module and reagent disk (-A/-B) on which the test was performed. For
immunological modules the measuring channel is displayed (-1/-2).
D Test Short test name.
E Code Application code
F Routine Sum of measured routine samples for each test
G Rerun Sum of measured rerun samples for each test
H STAT Sum of measured STAT samples for each test
I Calib. Sum of measured calibrator samples for each test
J Control Sum of measured control samples for each test
K Total The Total column displays the sum of all measured samples for each test.
The Total row after each module displays the sum of the measured samples for each
column.
The Total row after the last module displays the sum of the measured samples for each
column of all modules.
y Fields and columns in the Test Count area
Roche Diagnostics
No. of Sample This table includes the total number of routine, rerun, and
STAT samples as well as the grand total.
A B C D E
Operator ID: admin 2014/09 /08 20:40

No. of Sample
Module Routine Rerun Stat Total
A1- A 35 0 2 37
A1- B 42 0 2 44
A2- A 21 0 1 22
A2- B 51 0 1 52
A3- A 67 0 2 69
A4- 1 16 0 1 17
A4- 2 16 0 1 17
I1 60 0 2 62
I2 59 0 1 60
Total 367 0 13 380
A Module C Rerun E Total

B Routine D STAT
w Cumulative Operation List report – No. of Sample

A Module Short name of the module and reagent disk (-A/-B) on which the test was performed. For
immunological modules the measuring channel is displayed (-1/-2).
B Routine Sum of measured routine samples for each module
C Rerun Sum of measured rerun samples for each module
D STAT Sum of measured STAT samples for each module
E Total The Total column displays the sum of all measured routine, rerun, and STAT samples for

each module.
The Total row displays the sum of each column.
y Fields and columns in the No. of Sample area
Roche Diagnostics
No. of Detection Channel This table indicates the total number of measurements
each measuring channel was used for.
A B C
No. of Detection Ch.

Module No. After Clear Total
A 3- 1 552 552
A 3- 2 567 567
A 4- 1 224 224
A 4- 2 227 227
System Name: c8000 3 of 3
A Module B No. After Clear C Total
w Cumulative Operation List report – No. of Detection Channel
Column Explanation
A Module Short name of the module and detection channel
B No. After Clear Test count for each measuring channel after reset
The test count should be cleared by service personnel when the measuring cell is
exchanged.
C Total Test count for each measuring channel
y Columns in the No. of Detection Channel area
Roche Diagnostics
Application Parameters
f Print > Utility > Application Parameters

application and module from the Test list on Utility
> Application. You can select multiple applications using
the CTRL key.
Select Application Parameters from the report list to print

the application parameters for the selected test(s).
Roche Diagnostics
Application Parameters report
Test No. 1
Test Name Na
Application Code 989
Module ISE
Sample Type Ser/Pl
Calib.
Changeover To Bottle Full
Timeout To Bottle Cancel
Timeout To Bottle Expiration Date
Auto. Masking Yes
Compensated Limit 20.0
Range
Unit mmol/L
Decimal Places 0
Automatic Rerun No
Control Interval Time No
Auto. QC On Board Stability Time No
Technical Limit (lower limit) -99999

Technical Limit (upper limit) 999999
Repeat Limit (lower limit) -99999
999999
w Application Parameters report for an ISE test as an example
The application parameters listed in this report depend on

module(s) selected from the Test list on Utility
> Application.
The report contains all parameter settings of the selected

test(s).
Photometric tests u For the explanation of the application parameters, see:

Analyze (photometric tests) (1819)
Calib. (photometric tests) (1830)
Range (1837)
Other (photometric tests) (1842)
Immune tests u For the explanation of the application parameters, see:

Analyze (immune tests) (1827)
Calib. (immune tests) (1834)
Range (1837)
ISE tests u For the explanation of the application parameters, see:

Calib. (ISE tests) (1828)
Range (1837)
Other (ISE tests) (1841)
Serum indices u For the explanation of the application parameters, see:

Analyze (serum indices) (1825)
Compensated tests u For the explanation of the application parameters, see:

Formula (Compensated Test) (1844)
Roche Diagnostics
Profile List
f Print > Utility > Profile List
Select this item from the report list to print the Profile List
report.
Profile List report
The Profile List contains the names of each profile and the

tests assigned to each profile programmed on the system.
A B C D

Ser/Pl
No. Name Test
2 ernst ALTL CA
3 LIPC ALTL ASTL CHO2A LIPC
19 Na_K K Na
20 ISE Cl K Na
Urine
No. Name Test
1 ISE Cl K Na
A Sample Type C Name

B No. D Test
w Profile List report
Roche Diagnostics

A Sample Type Sample type selected for the profile
B No. Profile numbers 1–20
C Name Name of each profile
* In front of the profile name indicates the currently used routine
(asterisk) default profile selected on Start > Default Profile.
# In front of the profile name indicates a STAT default profile.
(pound sign)
D Test The short test name of each test in a profile is displayed in up to 7 columns from left to
right.
y Fields and columns in the Profile List report
Rack Archival Report

f Print > Utility > Rack Archival Report
Rack Archival Report.
Data Selection area
All Select this option to print a Rack Archival Report for all
dates.
Roche Diagnostics
Settings.
on the report.
Rack Archival Report
The Rack Archival Report lists archived racks.
A B C D E

Data Range: 2009/06/02 11:08 - 2009/06/02 11:12
Tray No. : 1 Archival Date: 2009/06/02 11:08 - 2009/06/02 11:09
Operator ID :
System Name : C8000 Serial No. : 0800-14
Tray
Tray Pos.: 2
R ac k No. - P os . S eq. No. S ample ID S . T ype C omment- 001
C20002-1 00502000000601878 ISELOW
C20002-2 00503000000607084 ISEHIGH

C20002-3 00504000000152250 ISECOMP
C20002-4
C20002-5
Tray Pos.: 3
R ac k No. - P os . S eq. No. S ample ID S . T ype C omment- 001
C20006-1 00901000000999999 H2O
C20006-2 00401000000181260 CFAS
C20006-3 00656000000150501 CF P
C20006-4
C20006-5
F G H I J K
A Tray No. E Serial No. I Sample ID

B Archival Date F Tray Pos. J S. Type
C Operator ID G Rack No. – Pos. K Comment
D System Name H Seq. No.
w Rack Archival Report
Roche Diagnostics

A Tray No. Tray number
B Archival Date Range of date and time covered by the report
C Operator ID ID of the operator logged on when the last tray was on the system
D System Name Name of the system
E Serial No. ID number of the instrument
F Tray Pos. Tray position
G Rack No. – Pos. Rack number (first 5 digits) and position number (last digit) for the sample
STAT: S RRRRR – P
Wash: W RRRRR – P
H Seq. No. Sequence number of the sample
I Sample ID Sample identification number
J S. Type Sample material type
For Calibrator, QC and Wash racks, nothing is displayed.
K Comment The display of this column differs depending on the rack type.
Rack Comment
Routine, Rerun, STAT The main comment title and text entered on the Sample
Information window is displayed.
QC The control name is displayed
Calibrator For chemistry tests, the calibrator name is displayed.

For immune tests, the test name and level is displayed.
Wash -
y Fields and columns in the Rack Archival Report
Roche Diagnostics
Cell Blank Measurement

f Print > Utility > Cell Blank Measurement
Select this item from the report list to print the Cell Blank
Measurement report.
Module Select the check box for the desired module. If selected,
the Start Cell and End Cell text boxes are activated.
Start Cell/End Cell Enter the starting and ending cell numbers for each
module in the report. The range of each entry is 1 to 406

for the c 701/c 702 modules and 1 to 160 for the c 502
module.
For a description of the report sheet see:

u See Cell Blank Measurement report (1464).
Roche Diagnostics
Maintenance Report
f Print > Utility > Maintenance Report

Maintenance Type from Utility > Maintenance.
Select Maintenance Report from the report list to print a list

containing date, time, operator ID, and comments for the
selected maintenance items. Specific maintenance items
can be printed on the Maintenance Report if previously
selected from the Maintenance list on Utility > Maintenance.
Maintenance area
Use this area to print a Maintenance Report for all

maintenance items or only for selected maintenance items.
All Select the All option to print the Maintenance Report for all
maintenance items of the selected Maintenance Type
performed on the system.
Selected Select the Selected option to print the Maintenance Report

for only the maintenance items selected on Utility
> Maintenance.
Module area
Select the Module check box(es) to print the Maintenance

Report for only the modules selected. Select the check box
of the desired module. The check boxes available vary
depending on your system configuration.
Roche Diagnostics
Date Range area
Use this area to enter the date range for printout.
All Select the All option to print the Maintenance Report for all
maintenance performed.
Last Select the Last option to print the Maintenance Report for
only the last maintenance item performed.
Range Select the Range option to print the report for a range of
> Display Settings.
on the report.
Roche Diagnostics
Maintenance Report
The Maintenance Report provides a log showing each

maintenance activity performed on the system. Each
maintenance item is listed, followed by the date, the time,
the operator ID of the person who initiated the
maintenance activity, and any pertinent comments. The
activities are presented in chronological order with the
most recent activity at the top.
A
B
Power On Time 296 Hours
Operation Time 44 Hours
C
Maintenance Type : Maintenance
Module : C7-1
D Cell Detergent Prime
Date Time Operator ID Comment
E
* 2009/06/24 09:29:44 bmserv
* 2009/06/23 17:31:00 SYSTEM
* 2009/06/23 08:51:58 bmserv
* 2009/06/22 06:39:55 SYSTEM
* 2009/06/19 09:25:31 SYSTEM
* 2009/06/18 06:39:04 SYSTEM
* 2009/06/17 07:54:16 SYSTEM
* 2009/06/16 08:54:06 SYSTEM
* 2009/06/11 06:38:55 SYSTEM
* 2009/06/09 06:39:02 SYSTEM
* 2009/06/08 06:42:41
* 2009/06/05 09:19:22
* 2009/06/04 16:27:24
* 2009/06/04 11:22:36
* 2009/06/03 09:45:26
* 2009/06/02 07:53:30
F G H I J
A Power On Time E Maintenance name H Time

B Operation Time F Status I Operator ID
C Maintenance Type G Date J Comment
D Module
w Maintenance Report

A Power On Time The total time (hours) the system was powered on.
This includes Standby and Operation.
B Operation Time The total time (hours) the system has been in Operation.
C Maintenance Type The type of maintenance activity included in the report.
Valid entries include Maintenance and Check.
D Module Name of the module and reagent disk on which the maintenance activity was performed
------- is printed for a maintenance pipe
y Fields and columns in the Maintenance Report
Roche Diagnostics

E Maintenance name Name of the maintenance activity
Maintenance item windows (1747)
Maintenance check windows (1787)
F Status * (asterisk) is displayed when a maintenance item is performed as a part of
maintenance pipe.
G Date The date the maintenance activity was performed.
H Time The time the maintenance activity was performed
I Operator ID ID of the operator who initiated the maintenance activity
J Comment Comments entered on the corresponding maintenance item or maintenance check
window.
y Fields and columns in the Maintenance Report
Roche Diagnostics
Cuvette History
f Print > Utility > Cuvette History
Select this item from the report list to print the Cuvette
History report.
Module Select the check box for the desired module. If selected,
the Series text box is activated.
Series Enter the cuvette series number (1 to 20). A series is one

use of reaction cells on the reaction disk. Series 1 is the
most recent use, Series 2 is previous to Series 1, with

Series 20 being the oldest.
Roche Diagnostics
Cuvette History report
The Cuvette History report displays a list of tests

performed in each cuvette on photometric modules.
A B C D

Module C1
Series 1
Unit C ell S eq. No. S ample ID T es t B lank / L ot ID S . T ype R . Type
Cycle 001 Time ---------- -----
Cycle 002 Time 06/10/2009 13:38:16

R2A 065 100080 CREJ2 612853 ------ R3
Cycle 003 Time 06/10/2009 13:38:18

M31 065 100080 CREJ2 ------ 10
Cycle 004 Time 06/10/2009 13:38:20

R2A 155 100080 CA 613143 ------ R3
M32 065 100080 CREJ2 ------ 10
Cycle 005 Time 06/10/2009 13:38:21

M31 155 100080 CA ------ 10
Cycle 006 Time 06/10/2009 13:38:23

M32 155 100080 CA ------ 10
E F G H I J K L

A Module E Unit I Test
B Series F Cell J Blank/Lot ID
C Cycle G Seq. No. K S. Type
D Time H Sample ID L R. Type
w Cuvette History report

A Module Short name of the module on which the actions were performed
B Series Series number (1–20) for the reported actions
C Cycle Number of the cycle (1–406) when the action was performed
D Time Date and time of the cycle when the action was performed
---------- ----- Empty cuvette
y Fields and columns in the Cuvette History report
Roche Diagnostics

E Unit Name of the unit that performed the action in the reaction cell
SA Sample pipetting unit A
SB Sample pipetting unit B
R1A Reagent 1 pipetting unit A
R2A Reagent 2 pipetting unit A
R1B Reagent 1 pipetting unit B
R2B Reagent 2 pipetting unit B
M11 Ultrasonic mixing unit 1 (R1 mixing – first time)
M12 Ultrasonic mixing unit 1 (R1 mixing – second time)
F Cell Reaction cell number:
On c 701/c 702, the number ranges from 001 to 406.
On c 502, the number ranges from 001 to 160.
G Seq. No. Kind of sample and sequence number that was used
Format Definition Sequence number
Empty cuvette
N Routine 000 001 to 060 000
E STAT 000 001 to 010 000
NR Rerun 000 001 to 060 000
ER Rerun STAT 000 001 to 010 000
C Control 001 to 100
S Calibrator x (standard series: 1 to 6)
y (pipetting series: 1 or 2)
R. Wash Reagent Probe Wash
C. Wash Cell Wash

Clot. Wash Wash after clot detection
For patient samples in barcode mode, only the code is displayed. In non-barcode mode,
the sequence number is attached to the code.
H Sample ID Sample identification number
For controls, the material number and control lot number is displayed.
For calibrators, the calibrator code and calibrator lot number is displayed.
I Test Short name of the test performed in the cuvette
* (asterisk) A serum index was measured for the test in the cuvette
J Blank/Lot ID Cell blank value when sample is pipetted in the corresponding cuvette
OR:
Reagent lot number when reagent is pipetted in the corresponding cuvette
K S. Type Samp.S A sample shortage is detected for a sample cup.
Samp.C A sample clot is detected for a sample cup.
D A sample was automatically diluted.
------ The cuvette is on a reagent unit
Roche Diagnostics

L R. Type --- The cuvette is on sample pipetting unit
The reagent, diluent, or wash solution type used in the cuvette:
R1 Reagent 1
R2 Reagent 2
R3 Reagent 3
Dil Diluent
D1 Detergent 1
D2 Detergent 2
D3 Detergent 3
W System water
If a number (1–16) is displayed in this column, it indicates the mixing level of the ultrasonic
mixing unit:
1–15 Photometric mixing levels
16 Sample dilution mixing level
Roche Diagnostics
Rack Delivery Trace

f Print > Utility > Rack Delivery Trace
Rack Delivery Trace.
Data Selection area
Use this area to select printing Rack Delivery Trace for all
racks, a specific rack, or for racks within a range of dates.
All Select this option to print Rack Delivery Trace for all dates.
Rack Select this option to print the Rack Delivery Trace report
for a specific rack. If this option is selected, the Rack text
box is activated.
Settings.
Rack Enter the rack number for the Rack Delivery Trace report.
on the report.
Roche Diagnostics
Rack Delivery Trace report
A B C D E

Dat e T ime R ac k No. E vent Detail
2009/ 05/ 29 15:16 C 20002 R ac k L oad P os .1 P os .2 P os .3
2009/ 05/ 29 15:16 C 20002 Search Sample TS P os .1 P os .2 P os .3
2009/ 05/ 29 15:16 C 20002 Rack Path Select (Order) 05
2009/ 05/ 29 15:17 C 20003 R ac k L oad P os .1 P os .2 P os .3 P os .4
2009/ 05/ 29 15:17 C 20003 Search Sample TS P os .1 P os .2 P os .3 P os .4
2009/ 05/ 29 15:17 C 20002 Tranceport Module ISE Pos.1 Pos. 2 Pos. 3
Cl K Na
2009/ 05/ 29 15:17 C 20003 Rack Path Select (Order) 01
2009/ 05/ 29 15:17 C 20002 Arrived Module ISE
2009/ 05/ 29 15:17 C 20003 Tranceport Module C1 Pos.1 Pos. 2 Pos. 3
ALTL ASTL CA CHO2A CHO2I CK CREJ2
CRJ2U GGTI2 GGTS2 GLUC3 IGG-2 LDHI2
A Date C Rack No. E Detail

B Time D Event
w Rack Delivery Trace report
Column Explanation
A Date The date of occurrence of event.
B Time The time the event was generated.
C Rack No. Rack number read from the labels on the rack.
Routine: RRRRR
STAT: S RRRRR

Rerun: R RRRRR
Quality Control: Q RRRRR
Calibrator: C RRRRR
Wash: W RRRRR
D Event The event information is printed.
E Detail Detailed information of an event is printed. If two or more details are printed, they are
separated with a space.
y Columns in the Rack Delivery Trace report
Roche Diagnostics
1454 Automatic Calibration Monitor report
Automatic Calibration Monitor report

The Calibration Monitor report includes calibration
information on the most recent calibration for the selected
tests. The report differs depending on the type of module
that was calibrated (ISE, photometric, or immunology).
u For individual report examples and explanations, see:
Calibration Monitor report (ISE module) (1454)
Calibration Monitor report (photometric
modules) (1456)
Calibration Monitor report (cobas e modules) (1459)
The report is automatically displayed on the History

window upon completion of the calibration.
u See History window (1374).
Calibration Monitor report (ISE module)
A B C D E
G
J
K
L
M
A Measurement Date F IS EMF J Slope

B Module G Std (1) Low EMF K IS Conc.
C Test H Std (2) High EMF L Std (3) Comp. Conc.
D Operator ID I Std (3) Comp. EMF M Comp. Value
E Calib. Alarm
w Calibration Monitor report – ISE test
Roche Diagnostics
Automatic Calibration Monitor report 1455

A Measurement Date The date and time when the calibration was performed on the system.
B Module The short name of the module on which the calibration was performed.
C Test The short test names.
D Operator ID The operator ID of the operator logged on when the calibration was performed.
E Calib. Alarm If a data alarm is issued during calibration, it is displayed after the result.
F IS EMF The measured voltage (or electromotive force, EMF) generated by the internal reference
solution at the specified electrode. The value is printed in millivolts (mV).
G Std (1) Low EMF The measured voltage generated by calibrator 1 (ISE Standard Low) at the specified
electrode.
H Std (2) High EMF The measured voltage generated by the calibrator 2 (ISE Standard High) at the specified
electrode.
I Std (3) Comp. EMF The measured voltage generated by the compensator (ISE Standard High, used as
calibrator 3) at the specified electrode.
J Slope The sensitivity of the specified electrode. The slope should gradually decrease with time,
reflecting the aging of the electrode.
If the slope falls outside of the optimal slope range values, a warning and an instrument
alarm are issued.
u About slope calculation (1951)
Overview of calibration quality criteria for ISE tests (1954)
K IS Conc. The measured concentration (mmol/L) of the internal standard determined during
calibration.
L Std (3) Comp. Conc. The measured concentration (mmol/L) of the compensator determined during
calibration.
M Comp. Value The compensation value (mmol/L) determined during calibration. This value is the
difference between the measured concentration of Std 3 shown in the S3 Conc. column
and the actual value of Std 3 (as entered in Calibration > Install). This value is added to or
subtracted from all subsequent control and patient values.
y Fields and columns in the Calibration Monitor report – ISE test
Roche Diagnostics
Calibration Monitor report (photometric modules)
w Calibration Monitor report – photometric test
This report provides a lot of details. The figure above

shows the complete report. The following cutouts of the
report are used for explanation of details.
Calibration Information This section displays general information about the

calibration such as measurement date or the test name.
A B C
D E F
A Measurement Date C Operator ID E SD Value

B Module D Test F Calib. Alarm
w Calibration Monitor report – photometric test (calibration information)
Roche Diagnostics
Field Explanation
A Measurement Date Date and time when the calibration was performed on the system.
B Module Short name of the module and reagent disk on which the calibration was performed.
C Operator ID ID of the operator logged on when the calibration was performed.
D Test Short test name
E SD Value SD value for the specified test
F Calib. Alarm Data alarm for the specified test issued during calibration.
y Fields in the Calibration Information area
Calibration Result and Calibration Factor Absorbance measurements (1 x 10⁴) for standards
1 through 6 are printed in separate rows.
A B C D E F G H
A Calibrator D Abs. 2 G Alarm

B Lot ID E Initial Abs. 1 H Calibration Factor
C Abs. 1 F Initial Abs. 2
w Calibration Monitor report – photometric test (Calibration result and Calibration factor)

A Calibrator Calibrator names of standards 1 through 6.
B Lot ID Lot numbers of standards 1 through 6.
C Abs. 1 Bichromatic absorbance of standards 1 through 6, replicate 1
D Abs. 2 Bichromatic absorbance of standards 1 through 6, replicate 2.
E Initial Abs. 1 Monochromatic absorbance of standards 1 through 6, replicate 1.
F Initial Abs. 2 Monochromatic absorbance of standards 1 through 6, replicate 2.
G Alarm Data alarm for Std(1) to Std(6)
If a data alarm is issued for both primary and secondary absorbance values, the alarm for
primary is displayed.
H Calibration Factor Calibration curve parameters such as S1Abs., K, A, B
y Fields and columns in the Calibration Result and Calibration Factor area
u Overview of calibration quality criteria for photometric

tests (1976)
Roche Diagnostics
Reagent Pack and Update Factor This area provides details specific to the reagent cassette
and the update factor.
A Reagent Pack
R1 R2 R3
B Lot ID 612854 612854
0001015 0001015
C Seq. No.
Update Factor
Factor 1
D
Factor 2
A Reagent C Seq. No. D Update Factor

B Lot ID
w Calibration Monitor report – photometric test (Reagent Pack and Update Factor)
Field Explanation
A Reagent Reagent pipetting time R1, R2, R3
B Lot ID Lot ID of the reagent cassette used at the pipetting time
C Seq. No. Sequence number of the reagent cassette used at the pipetting time
D Update Factor Update factor 1 and 2 derived from the calculation of calibration update
y Fields in the Reagent Pack and Update Factor area
Roche Diagnostics
Calibration Monitor report (cobas e modules)
Quantitative tests
A B C D E F G H
Calibration Monitor Operator ID: admin 09/ 04/ 2010 09:32

09/04/2010 09:32:50 A3-2 admin
Test Unit Calib. Lot ID Lot ID Seq. No.
CEA ng/mL 154433 15588000 033793
I
Evaluation Result Message
L-Calib. could not be generated
Released as R-Calib. By System
J Calibration Result
Level 1 Level 2
K Target 4.33 49.40
Signal 1 3451 29647
Signal 2 3465 29587
L _ _
Signal 3
Signal 4 _ _
Monotony _ _
M Diff. _ _
Dupl. _ _
N _ _
Sys. Err.
O
Factor
P 0.83

A Test G Lot ID M Monotony (e 602 modules only)
B Measurement Date H Seq. No. N Diff.
C Unit I Evaluation Result Message O Dupl.
D Module J Calibrator level L1–L5 P Sys.Err
E Operator ID K Target Q Factor
F Calibrator Lot L Signal 1-4
w Calibration Monitor report – immunology test (quantitative)
Field Explanation
A Test The short name of the test is displayed.
B Measurement Date The date and time when the calibration was performed on the system.
C Unit The measurement unit for specified test as defined on Utility > Application.
D Module The short name of the module and measuring channel on which the calibration was
performed.
E Operator ID The operator ID of the operator logged on when the calibration was performed.
F Calibrator Lot The lot number of the calibrator used for the calibration.
G Lot ID The lot number of the reagent cassette used for the calibration.
H Seq. No. The sequence number of the reagent cassette used for the calibration.
y Fields in the Calibration Monitor report – immunology test (quantitative)
Roche Diagnostics
Field Explanation
I Evaluation Result Message The message of the evaluated calibration is displayed.
If the calibration was performed with an expired reagent cassette, the expiry date is
displayed below the validation message.
J Calibrator level L1–L5 These columns display the values of the calibration criteria. For a qualitative calibration
L1 and L2 are used. For a quantitative calibration L1 to L5 are used.
K Target The target values of the calibrator, downloaded from the data manager.
L Signal 1-4 The measured signal level of the 1st, 2nd, … measurement of calibrator 1 or 2. For the
calculation of the calibration curve, the mean of the 1st and 2nd measurement is used.
Min is displayed on the report next to the signal if it is outside the test-specific limits.
Additionally, the <Sig flag is attached to the calibration result.
NG is displayed if no signal is available.
M Monotony (e 602 modules All measured calibrator values must fall in ascending (sandwich or bridging principle) or
only) descending (competition principle) order. This is called monotony.
NG is displayed if monotony is violated (Mono.E flag). The result is a failed calibration.
Troubleshooting tip: If calibrator was reconstituted or aliquoted, make sure calibrator 1
was placed in a white vial and calibrator 2 was placed in black vial.
N Diff. The difference in percent of the values between calibrator 1 and 2 is checked.
NG is displayed if the difference is below the permissible value (Diff.E flag).
Troubleshooting tips: Check if reagent and calibrators were at room temperature. Was
the calibrator reconstituted correctly or mixed up?
O Dupl. The deviation of the duplicate measurements of the signal values is checked.
NG is displayed if the difference between the duplicate measurements is too large (Dup.E
flag).
Troubleshooting tip: Check if reagent and calibrators were at room temperature.
P Sys.Err NG is displayed if a hardware error occurred during calibration measurement (Sys.E flag).
The result is a failed calibration.
Q Factor Each new lot calibration sets the calibration factor to 1.00. For all subsequent reagent
cassette calibrations, a new calibration factor is calculated. The calibration factor is the
quotient of the slopes of the currently performed calibration and the related stored
calibration.
A successful reagent cassette calibration has a calibration factor between 0.8 and 1.2
(otherwise Factor flag).
y Fields in the Calibration Monitor report – immunology test (quantitative)
u Overview of calibration quality criteria for immunology

tests (1981)
Roche Diagnostics
Qualitative tests
A B C D E F G H
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I
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K 䎶䏌䏊䏑䏄䏏䎃䎖䎐䎐䎐䎐
䎶䏌䏊䏑䏄䏏䎃䎗䎐䎐䎐䎐
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L
M 䎧䏌䏉䏉䎑䎶䏏䏒䏓䏈䎦䏘䏗䎃䎲䏉䏉䎥䏒䏕䏇䏈䏕䎃䏄䏕䏈䏄

䎐䎐䎐䎐䎓䎑䎓䎓䎓䎑䎜䎓䎐䎔䎑䎓䎓
N O P Q
A Test G Lot ID M Sys.Err

B Measurement Date H Seq. No. N Diff.
C Unit I Evaluation Result Message O Slope
D Module J Calibrator level L1–L5 P CutOff
E Operator ID K Signal 1-4 Q Border area

F Calibrator Lot L Dupl.
w Calibration Monitor report – immune test (qualitative)
Field Explanation
A Test The short name of the test is displayed.
B Measurement Date The date and time when the calibration was performed on the system.
C Unit The measurement unit for specified test as defined on Utility > Application.
D Module The short name of the module and measuring channel on which the calibration was
performed.
E Operator ID The operator ID of the operator logged on when the calibration was performed.
F Calibrator Lot This column displays the lot number of the calibrator used for the calibration.
G Lot ID The lot number of the reagent cassette used for the calibration.
H Seq. No. The sequence number of the reagent cassette used for the calibration.
I Evaluation Result Message The message of the evaluated calibration is displayed.
If the calibration was performed with an expired reagent cassette, the expiry date is
displayed below the validation message.
J Calibrator level L1–L5 These columns display the values of the calibration criteria. For a qualitative calibration
L1 and L2 are used. For a quantitative calibration L1 to L5 are used.
y Fields in the Calibration Monitor report – immune test (qualitative)
Roche Diagnostics
Field Explanation
K Signal 1-4 The measured signal level of the 1st, 2nd, … measurement of calibrator 1 or 2. For the
calculation of the calibration curve, the mean of the 1st and 2nd measurement is used.
Min or Max is displayed on the report next to the signal if it is outside the test-specific
limits. Additionally, the >Sig or <Sig flag is attached to the calibration result.
NG is displayed if no signal is available.
L Dupl. The deviation of the duplicate measurements of the signal values is checked.
NG is displayed if the difference between the duplicate measurements is too large (Dup.E
flag).
Troubleshooting tip: Check if reagent and calibrators were at room temperature.
M Sys.Err NG is displayed if a hardware error occurred during calibration measurement (Sys.E flag).
The result is a failed calibration.
N Diff. The difference in percent of the values between calibrator 1 and 2 is checked.
NG is displayed if the difference is below the permissible value (Diff.E flag).
Troubleshooting tips: Check if reagent and calibrators were at room temperature. Was
the calibrator reconstituted correctly or mixed up?
O Slope All measured calibrator values must fall in ascending (sandwich or bridging principle) or
descending (competition principle) order.
NG is displayed if slope is violated. The result is a failed calibration.
Troubleshooting tip: If calibrator was reconstituted or aliquoted, make sure calibrator 1
was placed in a white vial and calibrator 2 was placed in black vial.
P CutOff The calculated cutoff value for this sample. The cutoff value allows to classify the result
as being reactive or non-reactive.
Q Border area The lower and upper limit of the gray zone displayed in the units of the cutoff value. In the
gray zone (around cutoff value = 1) you cannot classify the result as being reactive or
non-reactive.
y Fields in the Calibration Monitor report – immune test (qualitative)

tests (1981)
u For a description of the calibration alarms, see:
Alarms for calibrations (1206).
Roche Diagnostics
Automatic Maintenance reports 1463
Automatic Maintenance reports

The reports discussed in this section are automatically
displayed on the History window upon completion of the
selected maintenance check.
Photometer Check report
The Photometer Check report can be printed upon

completion of the Photometer Check maintenance
function.
Choose Utility > Maintenance > Maintenance

> (3) Photometer Check and then choose Select to display
the Photometer Check window. Select one or more
photometric modules and then choose Execute to start the
photometer check.
q The Photometer Check report is displayed in Print

> History when complete.
The Photometer Check report displays the absorbance of

reaction cell no. 1 at all 12 wavelengths for the selected
photometric module. These absorbance readings are
taken with the reaction cell filled with water.
A B C D
A Module C Current Data

B Previous Data D Date and Time
w Photometer Check report
Roche Diagnostics
1464 Automatic Maintenance reports
Field Explanation
A Module Name of the module on which the check was performed
B Previous Data Absorbance of the last check
C Current Data Absorbance of the current check
D Date and Time Date and time when the check was performed
y Fields in the Photometer Check report
Cell Blank Measurement report
The Cell Blank Measurement report can be printed upon

completion of the Cell Blank Measurement maintenance
function.
Choose Utility > Maintenance > Maintenance > (4) Cell Blank
Measurement and then choose Select to display the Cell
Blank Measurement window. Select one or more
photometric modules and then choose Execute to start the
cell blank measurement.
q The Cell Blank Measurement report is displayed in Print

> History when complete.
The Cell Blank Measurement report displays the

absorbance of the selected range of reaction cells at all
12 wavelengths for photometric modules. These
absorbance readings are taken with the reaction cells filled
with water.
Roche Diagnostics
A B C D

Module AU2 C ell No. 1 - 406
Abnormal Cell List
244
Cell Blank Abs. 2009/06/24 09:50

Cell No. Wavelength (nm)
340 376 415 450 480 505 546 570 600 660 700 800
1 15093 13901 13041 12364 11882 11597 11188 10839 10689 10177 10004 9567
2 15405 14244 13346 12650 12158 11860 11433 11073 10919 10384 10202 9741
3 15051 13882 13013 12340 11861 11576 11173 10823 10674 10160 9988 9531
4 15018 13812 12992 12326 11855 11573 11170 10824 10678 10173 10007 9581
5 15087 13874 13039 12368 11892 11608 11199 10851 10701 10191 10020 9590
6 15071 13859 13028 12358 11881 11598 11193 10847 10698 10188 10019 9587
7 15127 13915 13055 12378 11901 11615 11206 10855 10700 10182 10005 9554
8 15200 13994 13117 12433 11948 11658 11244 10891 10740 10219 10045 9602
11980 11687 11267 10913 10759 10234 10059 9612
E F
A Module C Abnormal Cell List E Cell No.

B Cell No. D Date and Time F Wavelength (nm)
w Cell Blank Measurement report

A Module Name of the module on which the cell blank measurement was performed
B Cell No. Selected range of reaction cells for the corresponding module
C Abnormal Cell List If there are cells for which the cell blank measurement yields abnormal results, the

numbers of the respective reaction cells are listed here.
D Date and Time The date and time the last cell blank was performed.
E Cell No. Reaction cell number.
F Wavelength (nm) Absorbance (× 10⁴) readings of each reaction cell at each of 12 wavelengths (340, 376,
415, 450, 480, 505, 546, 570, 600, 660, 700, 800) are printed. This information is
automatically written to the hard disk as the cells are blanked.
Note: Results for reaction cells must be < 15 500.
y Fields and columns in the Cell Blank Measurement report
q If any result exceeds the result of cell no. 1 ± 1000,

refer to the Troubleshooting Guide for proper corrective
procedures.
u For module-specific information about troubleshooting

procedures, see:
Troubleshooting on cobas c modules (1249)
Roche Diagnostics
Disk Check report
The Disk Check report can be printed upon completion of

the Disk Check maintenance function.
Choose Utility > Maintenance > 2 Check > (1) Disk Check and
then choose Select to display the Disk Check window.
Choose Execute to start the check disk function.
q The Disk Check report is displayed in Print > History

when complete.
The Disk Check report lists the contents of the hard disk,
the system program version, and the check sum of the
instrument RAM and ROM for both the core and control unit
hard disks.
A B C D E F G
H Total
Total Files: 204 File (s)
I Total Size: 56401594 Byte (s)
Total Sum 8ffe
J
System Program Version 73457001-D1-02
K
A Directory D Size H Total Files

B File No. E Date I Total Size
C File Name F Time J Total Sum
G Sum K System Program Version
w Disk Check report
Roche Diagnostics

A Directory Directory name
B File No. Sequential number that the system assigns to the files on the hard disk
C File Name The file name
D Size The size (Bytes) of the file
E Date The date the file was last updated
F Time The time the file was last updated
G Sum Sum of each file
H Total Files Total number of files found on the hard disk.
I Total Size Total size (Bytes) of all the files found on the hard disk
J Total Sum Total sum of the files
K System Program Version Installed software version
y Fields and columns in the Disk Check report
Roche Diagnostics
ISE Check report
The ISE Check report can be printed upon completion of

the ISE Check maintenance function.
Choose Utility > Maintenance > 2 Check > (2) ISE Check and
then choose Select to display the ISE Check window. Enter
the cycles and then choose Execute to start the ISE check.
q The ISE Check report is displayed in Print > History

when complete.
The ISE Check report displays the ISE electrodes (Na, K, Cl,
and REF electrodes) and the corresponding measured
voltages.
A B C D E F
A Module C Na EMF E Cl EMF

B No. D K EMF F Ref. EMF
w ISE Check report

B No. Number of the ISE checks
C Na EMF The mean of measured voltage generated at the specified electrode.
A data alarm for Na issued during the check is displayed next to the measured voltage.
D K EMF The mean of measured voltage generated at the specified electrode.
A data alarm for K issued during the check is displayed next to the measured voltage.
E Cl EMF The mean of measured voltage generated at the specified electrode.
A data alarm for Cl issued during the check is displayed next to the measured voltage.
F Ref. EMF The mean of measured voltage generated at the specified electrode.
A data alarm for Ref issued during the check is displayed next to the measured voltage.
y Fields and columns in the ISE Check report
Roche Diagnostics
Sample Barcode Reader Check report
The Sample Barcode Reader Check report can be printed

upon completion of the Sample Barcode Reader Check
maintenance function.
Choose Utility > Maintenance > 2 Check > (6) Sample

Barcode Reader Check and then choose Select to display
the Sample Barcode Reader Check window. Choose
Execute to start the barcode reader check.
q The Sample Barcode Reader Check report is displayed

in Print > History when complete.
A B C

A Module B Rack C Pos.1 to Pos.5
w Sample Barcode Reader Check report

B Rack Rack number read from the labels on the rack
????? Barcode read error
y Fields and columns in the Sample Barcode Reader Check report
Roche Diagnostics

C Pos.1 to Pos.5 Sample barcode number read for each position in the rack
* ---------------------- Positions do not contain samples
(an asterisk and 22
dashes)
---------------------- Barcode read error
22 dashes
y Fields and columns in the Sample Barcode Reader Check report
Reagent ID Reader Check report
The Reagent ID Reader Check report can be printed upon

completion of the Reagent ID Reader Check maintenance
function.
Choose Utility > Maintenance > 2 Check > (7) Reagent ID

Reader Check and then choose Select to display the
Reagent ID Reader Check window. Select one or more
modules, enter the number of cycles and then choose
Execute to start the reagent ID reader check.
q The Reagent ID Reader Check report is displayed in

Print > History when complete.
Roche Diagnostics
Reagent ID Reader Check report (photometric

modules)
A B C
OK NG
Total 19 0
System Name: c8000 2 of 2

D
A Module C Result D Total

B Pos.
w Reagent ID Reader Check report – cobas c modules

A Module Name of the module on which the check is performed
B Pos. Position number of the reagent disk that was checked
C Result Reagent cassette of the corresponding position.
The identification number was read either from the barcode label or from the RFID tag on
the reagent cassette.
(space) Read error for the corresponding position
D Total Total sum of reader checks
OK The total sum of the reader checks that have no problems.
NG The total sum of the reader checks that have problems.
y Fields and columns in the Reagent ID Reader Check report – cobas c modules
Roche Diagnostics
Reagent ID Reader Check report (cobas e

modules)
A B C
Reagent ID Reader Check Operator ID: admin 09/ 04/ 2010 09:32
Module A3-1
Pos. Result Pos. Result Pos. Result Pos. Result Pos. Result
1 OK 8 OK 15 - 22 - 4 OK
OK NG
Total 3 0
A Module C Result D Total

B Pos.
w Reagent ID Reader Check report – cobas e modules
Field Explanation
A Module Name of the module and channel on which the check is performed
B Pos. Position number for the reagent that was checked (e 602 module: 1–25, e 801 module:
1–48)
C Result Result of reader check for the corresponding position is displayed
OK Reader check is normal, no problems
NG Read error
-- Non-installed reagent
(double dashes)
D Total Total sum of reader checks.

OK The total sum of the reader checks that have no problems.
NG The total sum of the reader checks that have problems.
y Fields in the Reagent ID Reader Check report – cobas e modules
u Related topics
• History window (1374)
Roche Diagnostics
Start window 1473
Start window
f Start
f Press F2
w Start window (barcode mode)
Use this window to define or request operating parameters

such as start up pipe setting, rerun mode, Rack Reception
mode, masking, and default profile.
u For more information on each of these items, see:

Start Up Pipe Setting area (1474)
Automatic Rerun area (1474)
Rack Reception area (1475)
CLAS Connection area (1476)
Masking (1476)
Default Profile (1476)
u For detailed operation procedures, see:
Processing samples (574)
u For detailed information about masking, see:
Masking tests for sample measurement (579)
Masking tests for every measurement (578)
Roche Diagnostics
1474 Start window
Start Sample No. area (non-barcode mode)
Use this area to enter the start sample number (sequence

number) for each sample type. The sequence number can
be identical for all sample types or different if different
racks are used for each sample type.
The hard disk holds up to 12 000 sample records, which

can be numbered from 1 to 60 000.
q Once the hard disk is full, no more sample data can be

saved. In the Overview menu the Sample Data Clear button
turns red. To save further data, the hard disk must be
cleared.
The operator is required to clear the database daily.
Start Up Pipe Setting area
This area displays the currently selected start up pipe

name. If no start up pipe is selected, Cancel is displayed in
the Start Up Pipe Setting area.
Pipe functions are defined on Utility > System > Pipe

Settings.
u See Pipe Settings window (1713).
Change Choose Change to select the desired start up pipe from

the list box.
u See Start Up Pipe Setting window (1477).
Automatic Rerun area
This area indicates whether the automatic rerun setting is

active for routine and/or STAT samples (system-wide
setting for all tests). Yes indicates that reruns will be
performed if the application-specific rerun setting for a
test is enabled additionally. No indicates that reruns will
only be requested but not performed automatically.
q If a result is flagged with a data alarm, a rerun test is

wide and application-specific settings. Only if both settings
are enabled a rerun test of this test is performed
automatically.
u For detailed information about automatic reruns, see

Processing rerun tests (595).
Roche Diagnostics
Start window 1475
Change Choose Change to display the Automatic Rerun window.

u See Automatic Rerun window (1478).
Time To Unload area
This area displays the time when all reagent cassettes,

which are reserved for unloading, are automatically
transferred from the reagent disks to the unloading tray. If
the module is in Operation at this time, unloading is
performed after the module goes in Rack Reception mode.
The Time to Unload settings are defined on Utility > System

> Reagent Manager Settings.
Change Choose the Change button to display the Time To Unload

window.
u See Time To Unload window (c 702 module) (1479).
Rack Reception area
For the Rack Reception mode to be available for an

analysis, it is necessary to activate and configure this
mode on Utility > System > Rack Reception. If this is the
case, you can choose to use the Rack Reception mode for
the current analysis here on the Start dialog box.
If Yes is displayed in the Rack Reception area, the mode is

used for the current analysis. If No is displayed, the mode is

inactive.
q Pressing the Stop (global button) would stop

operation on all modules. Results currently being
processed would be lost! All pipetted samples would be
lost and must be reloaded. Furthermore, reaction cells
would not be washed and, on cobas e modules, finalization
would not be performed.
o To terminate the Rack Reception mode, choose the
Change button in the Start dialog box. Then the
instrument will go into Standby mode and you may start
performing maintenance, for example.
o Never choose Stop (global button) to terminate Rack
Reception mode.
u For information on how to change the system settings

for the Rack Reception mode, see Rack Reception
Mode (1704).
Roche Diagnostics
1476 Start window
Change Choose the Change button to clear or select the check box
in the Rack Reception window.
u See Rack Reception Mode window (1480)
CLAS Connection area
This area displays when the connection to a Clinical

Laboratory Automation System (CLAS) is enabled. If
enabled, Yes is displayed. If No is displayed, the function is
disabled.
The CLAS settings are defined on Utility > System

Configuration > CLAS Settings.
Change Choose the Change button to temporarily disable the

connection to a Clinical Laboratory Automation System
(CLAS), like MODULAR PRE-ANALYTICS (MPA).
u See CLAS Connection window (1481)
Buttons
Start Use this button to start an analysis run.
Masking Use this button to manually mask/unmask tests and

modules.
u See Masking window (1482).
Default Profile Use this button to define the profile and sample types to be
used as the default if no test selections are made for a

sample.
u See Default Profile window (1486).
Roche Diagnostics
Start Up Pipe Setting window 1477
Start Up Pipe Setting window

f Start > Change (Start Up Pipe Setting area)
Use this window to select the desired Start Up Pipe from

the list box. The maintenance items included in the
selected Start Up Pipe will be executed automatically
before start of analysis.
OK Choose OK to accept the change.
Cancel Choose Cancel to close the window without saving any

changes.
No Pipes are displayed if no maintenance pipe has been

defined. At least one maintenance pipe must have been
defined on Utility > System > Pipe Settings first.
u For more information about maintenance pipes, see
Pipe Settings window (1713).
Roche Diagnostics
1478 Automatic Rerun window
Automatic Rerun window

f Start > Change (Automatic Rerun area)
Use this window to select or clear Routine and/or STAT

samples for automatic rerun. This is the system-wide rerun
setting for all tests.
By means of the application-specific setting you can

exclude tests from the automatic rerun (Utility > Application
> Range).
q If a result is flagged with a data alarm, a rerun test is

wide and application-specific settings. Only if both settings
are enabled a rerun test of this test is performed
automatically.
u For detailed information about automatic reruns, see

Processing rerun tests (595).
Cancel Choose Cancel to close the window without any changes.

Roche Diagnostics
Time To Unload window (c 702 module) 1479
Time To Unload window (c 702 module)

f Start > Change (Time To Unload area)
Use this window to enable or disable the Time To Unload

Mode. Select the Time To Unload Mode check box to use
this mode for the next analysis.
u For information about unloading reagent cassettes,
see Unloading reagent cassettes from the c 702
module unloading tray (353).
u For information about configuration, see Reagent
Manager Settings window (c 702 module) (1718).
Set Time Use these text boxes to specify a time when all reagent
cassettes selected for unloading should be automatically
transferred from the reagent disks to the unloading trays
of the c 702 modules.
Roche Diagnostics
1480 Rack Reception Mode window
Rack Reception Mode window

f Start > Change (Rack Reception area)
Use this window to enable or disable Rack Reception mode

for the current analysis. The duration of the Rack
Reception mode – from start of analysis to Standby – is
displayed in the Start window.
The Rack Reception mode must have been activated and

configured on Utility > System > Rack Reception. If this is
the case, you can enable or disable the Rack Reception
mode for the current analysis here.
This check box can be selected or cleared in each status

except the Post Operation status.
q Pressing the Stop (global button) would stop

operation on all modules. Results currently being
processed would be lost! All pipetted samples would be
lost and must be reloaded. Furthermore, reaction cells
would not be washed and, on cobas e modules, finalization
would not be performed.
o To terminate the Rack Reception mode, choose the
Change button in the Start dialog box. Then the
instrument will go into Standby mode and you may start
performing maintenance, for example.
o Never choose Stop (global button) to terminate Rack
Reception mode.
u For information on how to change the system settings

for the Rack Reception mode, see Rack Reception
window (1704).
Roche Diagnostics
CLAS Connection window 1481
CLAS Connection window

f Start > Change (CLAS Connection area)
Use this window to enable or disable the connection

temporarily.
CLAS Connection Select this check box to enable the connection to a CLAS
(clinical laboratory automation system) like the MODULAR
PRE-ANALYTICS (MPA).
Operating with a pre-analytical system (641)
Roche Diagnostics
1482 Masking window
Masking window
f Start > Masking
Use this window to manually Test Mask, Patient Mask or

Unmask tests and to access the Module Masking window.
Manually masked tests and modules are not used in the
current analysis.
u Overview of masking functions (639).
Test This table displays all tests that are assigned on each
module.
Select a test(s) to mask or unmask the test(s). Any number

of tests can be masked. Tests can be masked completely
or just for individual modules and channels.
Unmask/Test Mask/ These fields display the color for Unmask, Test Mask,
Patient Mask/Module Mask Patient Mask, and Module Mask.
There are two possibilities to mask a test:

• If Test Mask is selected, no patient samples, no
controls, and no calibrations can be performed.
• If Patient Mask is selected, the test is masked for
patient samples only—calibration and QC can be
performed.
Test is unmasked
Test is masked for any kind of sample (Test Mask)
Roche Diagnostics
Masking window 1483
Test is masked only for patient samples (Patient Mask)
Module is masked on the Module Masking window
q The system does not need to be in Standby to mask or

unmask a test.
Masking performed at the control unit is reflected in the
data manager and vice versa.
Mask on scheduling within module Use this check box to define the time at which a measuring
cell (MC) of an e 801 or e 602 module is masked.
• If the check box is selected, the MC is masked
immediately and scheduled samples are not processed.
Scheduled test orders that have not been processed
are flagged "M" (masked) in the Test Review window.
• If the check box is not selected, the MC is not masked
immediately and already scheduled samples are
processed to completion. However, samples that were
not yet scheduled will be masked as soon as they are
scheduled.
q Scheduled samples are never transferred to another

measuring cell (MC) regardless of whether the check box is
selected or not.

Button
Module Masking Choose the Module Masking button to display the Module
Masking window. Use this window to mask an individual
module so certain maintenance items can be performed on
the masked module while the other modules are still
processing samples.
u See:
Module Masking window (1484)
Roche Diagnostics
1484 Module Masking window
Module Masking window

f Start > Masking > Module Masking
Use this window to mask an individual module so certain

maintenance items can be performed on the masked
module while other modules are still processing samples
(background maintenance).
q Prior to masking, the module completes any samples

assigned to it. The masking process can take a couple of
minutes depending on the number of samples and the tests
selected. During the masking process, a dotted gray cross
is displayed on the module button and the module status
can not be changed.
Then the status of the module changes to Standby.
u For detailed instructions, see Masking a module for

background maintenance (775).
Module buttons Choose the corresponding button to mask or unmask a

module. The symbol on the button indicates the current
status of the module. Choose the module button again to
toggle between Module Mask, Service Mask, and Unmask.
Afterwards, choose Execute to allow the changes to take
effect.
q The module can be masked/unmasked only when the

system is either in Standby or Operation. If the first module
is masked, the ISE module is automatically masked as well.
If an ISE support box is part of the instrument and the first
module is masked, only the ISE module is masked and not
the ISE support box.
Service mask is used by Roche service personnel only.
Roche Diagnostics
Module Masking window 1485
Legend
The legend is located at the top right of the window. The

legend explains the possible statuses of the module
buttons.
Masking The module is currently in the process of changing from

unmask to mask. Then the status of the module will change
to Standby.
Unmasking The module is currently in the process of changing from

mask to unmask.
Module Mask The module is unavailable for operation. This status may be
used to replace reagents or to perform background or
parallel maintenance.
Service Unmasking The module is currently in the process of changing from

service mask to unmask.
Service Mask The module is unavailable for use (must only be used by
Roche service personnel). The module can only be
accessed by Roche service PCs.
Roche Diagnostics
1486 Default Profile window
Default Profile window

f Start > Default Profile
This window can be accessed by operators with

administrator level password only.
Use this window to define the profile for a sample type to

be used as the default if no test selections are made for a
sample.
q Profiles are defined on Utility > System > Key Settings

> Profile Setting.
Routine/STAT Default profiles are defined separately for STAT and

routine samples. Therefore use both areas with the profile
lists.
Sample Type/Profile List Next to the sample types, the corresponding profile lists
are displayed. These lists display the available profiles for
the corresponding sample type. Use these lists to select

the profile that is to be used for the corresponding sample
type as the default.
q The OK button turns yellow when any changes are

made.
Roche Diagnostics
Confirmation window 1487
Confirmation window
Use the buttons on the Confirmation window to continue
with the action or to stop the action.
Yes/OK/Execute Choose Yes, OK, or Execute to start or complete the

action.
No/Cancel/Close Choose No, Cancel, or Close to stop or cancel the action.
Roche Diagnostics
1488 No help available
No help available
For this topic, there is no help available.
Roche Diagnostics
1489
Table of contents
Workplace menu 23
Use the Workplace menu to make test selections, specify

sample information, assign patient ID numbers and position
numbers to samples, as well as review, backup, edit, delete
and send data to the data manager.
In this chapter 23
Test Selection submenu . . . . . . . . . . . . . . . . . . . . . . . . . 1491
Sample Information window . . . . . . . . . . . . . . . . . . . . . . 1499
Barcode Read Error window (barcode mode) . . . . . . . 1500
Rerun Rack Assignment window (non-barcode mode) 1502
Repeat window (non-barcode mode) . . . . . . . . . . . . . . 1503
Data Review submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . 1504
Read Backup window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1511
Filter window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1512
Search Sample window . . . . . . . . . . . . . . . . . . . . . . . . . . 1514
Unload Rack window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1516
23 Workplace menu
Change Priority window . . . . . . . . . . . . . . . . . . . . . . . . . 1517
Send to DM window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1518
Backup Data window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1520
Test Review window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1522
Reagent Detail window . . . . . . . . . . . . . . . . . . . . . . . . . . 1528
Original Data window. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1529
All Results window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1533
Reaction Monitor window . . . . . . . . . . . . . . . . . . . . . . . . 1537
Scale Setting window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1540
Roche Diagnostics
1490
Table of contents
Overlay window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1541

Calib. Review submenu . . . . . . . . . . . . . . . . . . . . . . . . . . 1544
23 Workplace menu
Roche Diagnostics
Test Selection submenu 1491
Test Selection submenu

f Workplace > Test Selection
w Test Selection submenu (barcode mode)
23 Workplace menu
w Test Selection submenu (non-barcode mode)
Roche Diagnostics
1492 Test Selection submenu
Test selections (or orders) are usually downloaded from

the LIS (host) via the data manager. As an alternative, test
selections may be entered manually in the data manager or
the Test Selection submenu, for example, when operating
without LIS connection.
u For information about sample processing, see:
About sample processing (541)
Ordering tests (550)
Working with barcodes (559)
Processing samples (574)
Processing rerun tests (595)
u For information on sample processing from the data
manager, please refer to the component Host backup in
the Operator’s Manual or the Online Help of the data
manager.
Use the Test Selection submenu to enter test selections

and information for a sample. After entries have been
made on the Test Selection submenu, choose the Save
button to save the test selections.
Fields
S. Type Use this list box to select the sample type. The following
sample types are available on the different modules.
Sample type name Short ISE and e 801 e 602 Comment

name cobas c module module
modules
Serum/Plasma Ser/Pl l l l
Urine Urine l l l
Cerebrospinal Fluid CSF l l –
Supernatant Suprnt l l – Use this sample type for
supernatants or for whole blood on
c 502 modules.
Others Others l l l If you select the sample type Others,
the instrument always takes the
23 Workplace menu
application data of Ser/Pl set in Utility

> Application. The application must
be available for Ser/Pl.
Whole Blood WhlBld – l –
Oral Fluid OraFlu – l –
Hemolysate Hemoly – l –
Amniotic Fluid AmniF – l –
Processed Stool Stool – l –
y Sample types
Sample ID Use this text box to define a sample ID number of up to

22 characters. Press the Tab key to move the cursor to
Sample.
Roche Diagnostics
q If the instrument is connected to an LIS (host), this

information is downloaded automatically and no entry is
necessary.
Sample Use one option (Routine or STAT) to select the sample class
for which details are to be entered.
• Routine
Select this option to enter test selections for a routine
sample.
• STAT
Select this option to enter test selections for a STAT
sample.
u Ordering routine samples manually (554)
u Ordering STAT samples manually (555)
Sequence No. Use this text box to enter the sequence number. The
(non-barcode mode) sequence number is used by the system to associate test
selections to a sample when the system is operating in non-
barcode mode. Type a sequence number in the text box
(1 to 60 000). Press Tab to move the cursor to Pre-dilution.
q This function is only available when Routine is

selected in the Sample area.
A sequence number is not required for STAT samples.
Rack No. - Pos. Use these text boxes to enter the rack number and the
(non-barcode mode) position of the sample tube in the rack for STAT samples.
Type the rack number in the first text box. Type the position
number (1 to 5) corresponding to the sample position in the
rack in the second text box.
q If samples are not properly placed in the rack

according to position assignment, sample results will be
23 Workplace menu
incorrect. When loading samples in racks, make sure that
the samples placed correspond with the positions entered.
u For more information about racks, see:

Loading samples (562)
Unloading samples manually (600)
Specifications of racks (2024)
Pre-dilution Select this check box if the sample has been manually
diluted. Press Tab to move the cursor to Sample Cup.
Sample Cup Use this list box to define the sample cup type, Normal or
Micro, used for the current sample. Select the appropriate
sample cup type from the list. Press Tab to move the cursor
to Sample Volume/Dilution.
Roche Diagnostics
q Micro cups are not to be used on the e 602 module.

Sample Volume/Dilution Use this list box to select the dilution ratio for the current
sample (Normal, Decrease, Increase). These volumes are
defined on Utility > Application > Analyze.
q Application-specific dilutions are performed

automatically by the system.
Sample dilutions differ in the different modules as follows:
o The c 701/c 702 modules perform dilutions and can
pipette increased or decreased sample volumes for the
specific test.
o The e 801/e 602 modules cannot pipette increased or
decreased sample volumes but are able to perform
dilutions. Not all dilution factors are available for all
e 801/e 602 tests.
o If the sample volume of a test is higher than 15 µL on
c 701/c 702 modules (20 µL on c 502 modules), a
manual dilution request is not accepted and a pop-up
window is displayed.
o If you choose a dilution ratio in the Sample
Volume/Dilution field, this selection will override the
pre-programmed dilution ratio indicated in the Utility
> Application > Analyze submenu.
To apply sample volume or dilution to a test, first select the

required volume/dilution, then select the test.
If a sample is analyzed with several tests, a different

volume can be defined for each test performed.
q All manual selections such as sample type and dilution

ratio remain selected until they are manually changed.
23 Workplace menu
Sample Status This field displays the status of the selected sample.
Possible statuses include:
Roche Diagnostics
blank Sample has been requested but not

registered yet.
Ordered Sample has been registered but not

pipetted yet, or an open order exists for
this sample.
Reasons for open orders (examples):
Test was masked, or a data alarm is
present and an automatic rerun is
requested.
Processing Sample is being processed.
Complete Sample successfully processed.
H Upload to Host
Sample results have been sent to the
data manager.
Incomplete Sample processed, but a data alarm is

present.
V Validation
Result is in the process of validation
(control results only).
Record Space This field displays the number of available records for
patient programming. 12 000 STAT and routine patient
records can be stored.
Test matrix
23 Workplace menu
A maximum of 192 test keys can be programmed on the

system. The test matrix has 32 keys in each group and up
to 6 groups of test keys can be programmed. One group at
a time is displayed in the Test Selection submenu. Use the
tabs above the test matrix to switch between the groups.
Group names and test keys are defined on Utility > System
> Key Settings. In addition, test profiles can be
programmed on Utility > System > Key Settings > Profile
Setting.
u See Key Settings window (1695).
Roche Diagnostics
Markings One test or profile can be assigned to each key. The test
keys display special markings depending on the test status
or programming. The different markings and their meanings
are outlined below:
Blank test key indicates no test is assigned.
Test key with a test or profile name and no masking

indicators. The test can be requested; additional settings
are not required. The reagent is on board and registered.
Mask: The test can be requested but is not measured

because the module or test is masked (Start > Masking).
The test will be measured after masking is manually
removed.
o Module Masked: Module is in Standby status to allow
performing maintenance or loading reagents.
o Patient Masked: Prevents patient samples from
running but the operator can still calibrate and
perform QC.
o Test Masked: Prevents the processing of calibration,
QC, and patient samples. The test is turned off.
Reagent mask (no reagent available)

Test is automatically masked by the system. The test
reagent is either empty or not present on the instrument.
The test can be requested; however, the test is
performed only if a new reagent is placed on the
instrument.
For cobas e modules: The test is also masked if a
pretreatment or diluent required by this test is empty or
not on board.
For all modules: The red bar is not displayed on the test
key (test is not masked) in the following cases:
o The corresponding reagent is available on another
module.
o Another diluent or a detergent is empty or missing (for
example SmpCln1, CellCln1, ECO-D or ProbeWash).
Calibration mask (calibration failed)

Test is automatically masked by the system if no valid
23 Workplace menu
calibration is available and the test requires a calibration.

The purple bar is not displayed on the test key in the
following cases:
o Calibration auto masking setting for the individual test
is not selected on Utility > Application > Calib..
o Calibration auto masking setting for the instrument is
not selected on Utility > System > Calib. and QC
Settings.
o The test has a valid calibration on another module.
Increase
o Test will be run with the increased sample
concentration set on Utility > Application > Analyze.
Roche Diagnostics
Decrease
o Test will be run with the decreased sample
concentration set on Utility > Application > Analyze.
Dilution Ratio
o Test will be run with a dilution. The number after the
triangle indicates the ratio of the dilution (for
example, 3 is 1:3).
o For cobas e modules: Test will be run with the
recommended dilution ratio set on Utility > Application
> Analyze.
Profile
o A brown bar on the key indicates a profile has been
assigned to the key. When selected, all tests assigned
to that profile are displayed with a blue border.
q If the reagent for a test is not on board, the

corresponding test key is marked with the reagent mask
symbol.
Colors The test keys display different colors to indicate the status
of the test for the sample ID in the Sample ID text box. The
following colors are available:
This test has been selected.
This test has been performed and a result is available.

The test may be reordered again.
Buttons
Sample Information Choose this button to display the Sample Information

window. Use this window to enter and view sample
information as well as the draw date and time. 23 Workplace menu
q This button is only active after a sample ID (barcode

mode) or a Rack ID and Position (non-barcode mode) have
been entered.
Barcode Read Error Choose this button to display the Barcode Read Error
(barcode mode) window. Use this window to enter information for a non-
readable barcode or a sample without a barcode.
u See Barcode Read Error window (barcode
mode) (1500).
Roche Diagnostics
Rerun Rack Assignment Choose this button to display the Rerun Rack Assignment
(non-barcode mode) window. Use this window to assign reruns to a particular
rack number and position. The assigned rack number and
position are displayed in the Rack No. -Pos. column on the
Data Review submenu.
u See Rerun Rack Assignment window (non-barcode
mode) (1502).
Repeat Choose this button to display the Repeat Test Selection

(non-barcode mode) window. Use this window to assign the same test selections
to several samples in sequence.
u See Repeat window (non-barcode mode) (1503).
Previous Use this button to display the previous sample number

stored on the system. The Test Selection submenu displays
the test assignment and all other settings relating to this
sample.
Next Use this button to display the next sample number stored
on the system. The Test Selection submenu shows the test
assignment and all other settings relating to this sample.
Save Use this button to save the changes. This button turns
yellow after entries have been made.
23 Workplace menu
Roche Diagnostics
Sample Information window 1499
Sample Information window

f Workplace > Test Selection > Sample Information
f Workplace > Data Review > Sample Information
Use this window to enter and view sample information

about the selected sample. The Sample Information
window is available for both STAT and routine samples.
Comment titles are defined on Utility > System > Comment
Titles.
q Sample information cannot be entered or changed

while the sample is processing.
u See Comment Titles window (1701).
Sample This field displays whether the sample is a Routine or STAT

sample.
Sequence No. This field displays the Sequence number in non-barcode

mode.
Sample ID This field displays the Sample ID number in barcode mode.
S. Type This field displays the Sample type, for example Ser/Pl.
Rack No. - Pos. This field displays the Rack No. and position of the sample.
Draw Date/Time Use these 5 text boxes to enter the date and time the
sample was collected. The date/time format is defined on
Utility > System > Display Settings. After entering a value in
23 Workplace menu
each text box, press Tab to move to the next.
Sample Info. Use this area to enter details about the sample.
Information entered here can appear on reports and in
other windows or menus.
A maximum of 30 characters can be entered in the first text

box, 25 in the second, 20 in the third, 15 in the fourth and
10 in the fifth. After completing each text box, press Tab to
move to the next.
The title for the comment text box is defined on Utility

> System > Comment Titles.
Roche Diagnostics
1500 Barcode Read Error window (barcode mode)
Barcode Read Error window (barcode

mode)
f Workplace > Test Selection > Barcode Read Error
Use this window to enter information for a sample with no

barcode or an unreadable barcode.
u Entering unreadable sample barcodes or sample IDs for
Fields
Sample Use this area to indicate whether the sample is a STAT or a

routine sample.
Sample Type Use this list box to select the sample type.
Rack No. - Pos. Use these text boxes to define the rack number and the
rack position. Type a rack number in the first text box. Type
the sample position number (1 to 5) in the second text box.
u For information on the possible rack number ranges,
see:
23 Workplace menu
List of racks with stabilizers (2027)

List of racks without stabilizers (2028)
Sample ID Use this text box to enter the sample ID number (maximum
22 characters). If the sample barcode is unreadable, enter
the sample barcode number here.
Sample list The sample list displays sample data which has been
entered in the Data Entry area. This list can be sorted by
type, rack no./pos. or sample ID. An arrow in the
appropriate column header distinguishes the selected
column.
Roche Diagnostics
Barcode Read Error window (barcode mode) 1501
Buttons
Add Use this button to add data entered in the Data Entry area
to the sample list. After adding a sample to the sample list,
the OK button turns yellow.
Delete Use this button to delete the sample data currently

selected in the sample list after confirmation. After
confirmation, the OK button turns yellow.
q The non-read position assignments are deleted once

the rack(s) to which samples are assigned are scanned by
the rack ID reader. Therefore, once the rack is read, it can
be re-used for different samples. If it is necessary to run
these samples again, the position assignment must be re-
entered.
23 Workplace menu
Roche Diagnostics
1502 Rerun Rack Assignment window (non-barcode mode)
Rerun Rack Assignment window (non-

barcode mode)
f Workplace > Test Selection > Rerun Rack Assignment
Use the Rerun Rack Assignment window to assign samples

that require a rerun to a rerun rack and a position.
u Assigning a sample to a rerun rack in non-barcode
mode (595)
Type This field displays the type of sample selected on

Workplace > Test Selection.
Sequence No. This field displays the sequence number previously entered
in the Workplace > Test Selection.
Sample ID This field displays the ID number of the sample selected on

Workplace > Test Selection.
Comment This field displays the comment entered for the sample on
the Sample Information window.
Rack No. - Pos. Use these 2 text boxes to enter the rack number and
sample position for the rerun sample. Type a rack number
23 Workplace menu
in the first text box and the sample position number (1 to 5)

in the second text box.
q You must use pink racks for manual rerun tests in non-
barcode mode.
Roche Diagnostics
Repeat window (non-barcode mode) 1503
Repeat window (non-barcode mode)

f Workplace > Test Selection > Repeat
w Repeat window (Routine)
w Repeat window (STAT)
Use this window to assign the same test selections to

several samples performed in sequence. Identical test
selections are programmed for the specified number of
samples.
Last Sequence No. Use this text box to enter the sequence number of the last
sample to be assigned to the repeat test selection. For
example, if the sequence number on Workplace > Test
Selection is 1201 and you wish to program 20 more
samples with the same tests, enter 1221 in this text box.
The maximum number to repeat is 300.
Last Rack No. - Pos. Use these text boxes to enter the rack number and position
number of the last sample to be assigned to the repeat
test selection.
23 Workplace menu
Roche Diagnostics
1504 Data Review submenu
Data Review submenu

f Workplace > Data Review
w Data Review submenu (barcode mode)
Use this submenu to perform tasks related to reviewing and

editing routine and STAT results. Control results can also
be viewed here. Additionally, use the Test Review window
to view the details of results and the Reaction Monitor
window to view absorbance values and reaction points.
Other tasks that can be performed from this submenu

include editing sample information, sending data to the
data manager, editing, searching, filtering, and deleting
data individually or in batches, and backing up data.
23 Workplace menu
Roche Diagnostics
Data Review submenu 1505
Upper buttons and fields
Data The information displayed in the sample selection list can

be read from the file, where the data is stored. Use this list
box to select the medium from which data is to be read.
• Routine View
Select this option to display data from the hard disk of
the instrument. This is the default.
• Backup View
Select this option to read and display data from a
backup file. Selecting this option will display the Read
Backup window. Use this window to specify the file
name and location from which patient data is to be
read.
u See Read Backup window (1511).
Filter ON/OFF Information that is displayed in the sample selection list

can be filtered by criteria defined on Workplace > Data
Review > Filter. Select the ON or OFF options in the Filter
area to toggle the filter on or off, respectively.
u See Filter window (1512).
Filter Choose this button to display the Filter window. Use this
window to define criteria to filter information displayed on
the sample selection list.
u See Filter window (1512).
Search Choose this button to display the Search Sample window.

Use this window to search for a sample using specified
search criteria.
u See Search Sample window (1514).
Sample Count This field displays the number of routine, control and STAT
sample records stored in the appropriate data base.
23 Workplace menu
Sample selection list
This list on the left side of the screen displays the samples
registered by the system. Its content varies depending on
whether barcode, or non-barcode mode is selected on
Utility > System > Barcode Settings.
The sample selection list consists of 8 columns that can be

sorted by S. ID, Comment, and Date/Time. An arrow in the
column. In non-barcode mode the list consists of 9 columns
(S. No. is added) that can be sorted by S. No., S. ID,
Comment, and Date/Time.
Roche Diagnostics
q The width of the individual columns can be adjusted by

clicking the column dividers in the list box head and
dragging them to the left or right.


manager yet.

manager.


e 801/e 602 modules

cobas c module.

q Immunology applications that are sensitive to sample

23 Workplace menu
HPI requests.
contamination.
St. This column displays the sample status codes.
Roche Diagnostics
No character Sample has been successfully

(Complete) processed. All test results are available
without a data alarm.
O (Ordered) Sample has been requested or

registered but not pipetted yet or an
open order exists for this sample.
Examples of reasons for open orders: All
tests requested were masked or an
automatic rerun test was requested due
to a data alarm.
P (Processing) Sample is being processed.

masked.
Seq. No. (non-barcode mode) Choose this column header to sort the list by sequence
number. The first character of the sequence number
indicates the rack type where the sample was placed—
S for STAT, and Q for quality control. The remaining
characters represent the sequence number of the sample.
For example: 50203 identifies the sample as a routine

sample with sequence number 203.
u List of racks with stabilizers (2027)
S. ID This column displays the sample ID number and for

controls, the short name. Choose this column header to
sort the list by sample ID.
Rack No. - Pos. This column displays the rack number and sample position
within the rack for the current sample.
S. Type This column displays the sample type.
Comment This column displays the main comment entered for the
sample. Choose this column header to sort the list by the
main comment. 23 Workplace menu
Date/Time Choose this column header to sort the list by the date and
time the samples were registered by the system. The
format is defined on Utility > System > Display Settings.
Test results list
This list on the right side of the screen displays the results
of the tests performed on the sample currently selected in
the left list.
Roche Diagnostics
C. E. This column displays whether the special wash specified

has been performed before pipetting.
# Special wash required for this test has not been

performed.
Dil. In this column a symbol for the sample volume to be used is

displayed. The sample volumes are defined on Utility
> Application > Analyze. Application-specific dilutions are
performed automatically by the system.
The test was measured with normal sample volume.

only.


displays the dilution ratio selected in the Workplace

q The c 701/c 702 modules perform dilutions and can

pipette increased or decreased sample volumes for the
specific test.
The e 801/e 602 module cannot pipette increased or
decreased sample volumes but is able to perform dilutions.
Not all dilution factors are available for all e 801/e 602
tests.
23 Workplace menu
Test This column displays the test processed for the currently
selected sample.
Result This column displays the results for the selected sample. If
a test has already run twice and a third request is made,
the result of the second run is replaced by the result of the
third run.
Unit This column displays the unit (for example, g/L or U/L) of
the test for the selected sample.
Alarm This column displays any data alarm associated with the
result of the test for the selected sample.
Roche Diagnostics
q If a result is edited in the Test Review window, Edited is

displayed in the Alarm column.

- The current reagent cassette has been

used up since the barcode of the QC
sample was read by the core unit. The
QC measurement was performed using
the first standby reagent cassette.
SB1 The first standby reagent cassette after

the currently used reagent cassette

3rd This column displays the sample concentration for the 3rd
order.
The test is to be run with normal sample concentration.
The test is to be run with an increased sample

concentration. This applies to photometric assays only.
The test is to be run with a decreased sample

concentration. This applies to photometric assays and
ISE tests only. For ISE tests, only urine samples can be
run with decreased volume.
23 Workplace menu
The test is to be run with a diluted sample.
Samp. Pos. This column displays the position of the control in the rack.
Lower Buttons

information as well as the draw date and time. A sample
must be selected from the sample selection list for the
Sample Information button to be active.
Roche Diagnostics
Unload Rack Choose this button to unload a sample rack selected

before. A confirmation window appears. Choose Yes to
unload the displayed rack. Choose No to close the window
without unloading.
u See Unload Rack window (1516).
Change Priority Choose this button to process the selected sample rack
with STAT priority. A confirmation window appears. Choose
Yes to prioritize the displayed rack. Choose No to close the
window without any changes.
u See Change Priority window (1517).
Send to DM Choose this button to display the Send to DM window. Use

this window to define the data to send to the data
manager.
u See Send to DM window (1518).
Delete Record Choose this button to delete sample records, including

results and test selections, after confirmation.
Delete All Choose this button to delete all sample records, including
results and test selections. After confirmation, the sample
count is reset to 0.
Backup Data Choose this button to display the Backup Data window. Use
this window to store data.
Test Review Choose this button to open the Test Review window. Use
this window to review and edit test results.
u See Test Review window (1522).
Reaction Monitor Choose this button to display the Reaction Monitor window.
Use this window to view the reaction graph for a specific
test on a specific sample.
u See Reaction Monitor window (1537).
23 Workplace menu
Roche Diagnostics
Read Backup window 1511
Read Backup window

f Workplace > Data Review > Data > Backup view
Use this window to enter the backup file name on the

storage medium (DVD).
q Only data saved in binary format can be read by the

system. Use the Data Backup option from Workplace > Data
Review > Backup Data.
File Name Use this text box to enter the backup file name to be read
from the storage medium or choose the button next to it to
display the Open File window and search for the file to be
read.
23 Workplace menu
Roche Diagnostics
1512 Filter window
Filter window
f Workplace > Data Review > Filter
Use this window to define filter criteria used to filter the

information displayed in the sample selection list.
q The filters work individually, i.e. the conditions are not

AND-linked.
If you select the Analyzed Unit and Analyzed Test options,
for example, all samples are displayed that have been
processed on this analytical unit. In addition, all samples
are displayed for which this test has been measured.
The filter can be toggled on and off in the Filter area at the
top left corner of the Data Review submenu.
u See Filter ON/OFF (1505).
Sample Use this area to filter results by sample classes. The

available options are: Routine, STAT and Control.
Sample Status Use this area to filter results by status of sample

processing.
S. Type Use this area to filter results by sample material.
DM Status Use this area to filter results by DM Sent status.
Analyzed Unit Use this option to filter results by module. For e 801/e 602
modules, the measuring channel is also displayed. Select
23 Workplace menu
the check box to activate the adjacent list box.
Analyzed Test Use this option to filter results by test. Select the check
box to activate the adjacent list box. All tests available on
the system are displayed in this list box.
Result with Rerun Only Use this option to filter results with reruns only.
Arrived Date Use this option to filter results within a defined arrival date
range. To define the range, enter the start date in the first
3 text boxes and the end date in the final 3 text boxes (the
date format is defined on Utility > System
> Display Settings).
Roche Diagnostics
Filter window 1513
Arrived Time Use this option to filter results within a defined arrival time
range. To define the range, enter the start time in the first
2 text boxes and the end time in the final 2 text boxes (the
time format is hh:mm).
23 Workplace menu
Roche Diagnostics
1514 Search Sample window
Search Sample window

f Workplace > Data Review > Search
w Search Sample window, left: barcode mode, right: non-barcode mode
Use this window to search for a sample in the database.

Search criteria and options, such as the sequence number
or sample number, are defined using this window.
Find Use this area to select the search option Sample ID,
Sequence No. or Comment-001 and to enter a search
string.
• Sample ID
Select the Sample ID option to search by sample
number. Select the sample number from the list below,
or enter the sample number or a part of the sample
number to be searched for.
• Sequence No. (non-barcode mode)
Select the Sequence No. option to search for a sample
23 Workplace menu
by sequence number. Select the sequence number

from the list below, or enter all or a part of the
sequence number to be searched for.
• Comment-001
Select the Comment-001 option to search by comment.
The Comment-001 title is defined on Utility > System
> Comment Titles. Enter the comment or a part of the
comment to search for in the list box below.
Search Option Select the Match Case check box to specify capitalized or
non-capitalized letters.
Roche Diagnostics
Search Sample window 1515
Comment-001 This field displays the comment of the sample found in the
sample selection list.
Focus Move Use the buttons in this area to search the sample.
• Down
Choose the Down button to search the sample
selection list of the Data Review submenu down from
current selected sample.
• Up
Choose the Up button to search the sample selection
list of the Data Review submenu up from current
selected sample.
23 Workplace menu
Roche Diagnostics
1516 Unload Rack window
Unload Rack window

f Workplace > Data Review > Unload Rack
Use this window to check that the correct rack is selected

for unloading. If you confirm with Yes, the rack will be
unloaded to the unloading tray regardless of the rack
supply source. Remaining test orders are masked. After the
sample is reloaded, remaining test orders will be measured
without reordering.
On the Data Review submenu, the samples on the rack

currently being unloaded are displayed in blue.
q An unloading process takes about 15 minutes on

average.
Once you have requested the unloading of a rack, the
unloading process cannot be stopped.
u For more information, see Unloading samples

manually (600).
Rack No. This field displays the number of the rack that was selected
for unloading.
Pos. This column displays the sample position within the rack.
Status This column displays the status of the sample.
S. ID This column displays the sample identification number.

23 Workplace menu
Roche Diagnostics
Change Priority window 1517
Change Priority window

f Workplace > Data Review > Change Priority
Use this window to increase the priority of the selected

routine or rerun rack. If you confirm with Yes, the rack will
be processed with STAT priority. This function is not
applicable to STAT, calibrator, and control racks.
Racks supplied via the STAT port are already processed

with STAT priority. The priority of these racks cannot be
increased by this function.
On the Data Review submenu, the samples on the

prioritized rack are displayed in red.
u For more information, see Changing the priority of
sample racks (576).
Rack No. This field displays the number of the rack that was selected
on Workplace > Data Review.
Pos. This column displays the sample position within the rack.
Status This column displays the status of the sample.
S. ID This column displays the sample identification number.
23 Workplace menu
Roche Diagnostics
1518 Send to DM window
Send to DM window
f Workplace > Data Review > Send to DM
f Workplace > Data Review > Reaction Monitor > Send to
DM
Use this window to send data to the data manager.
q Highlight the samples to be sent to the data manager

in the sample selection list on Workplace > Data Review,
then choose Send to DM.
Data Type
Use this area to select which data is to be sent to the data

manager.
Result Select the Result option to send the final result to the data
manager. When this option is selected, the Test DM Status
area is enabled and the Test list box is disabled.
Reaction Monitor Select the Reaction Monitor option to send results of

chemistry modules with raw absorbance data to the data
manager. When the Reaction Monitor option is selected,
the Test list box is enabled.
Raw Data Select the Raw Data option to send results of immune
modules with concentration to the data manager. When
23 Workplace menu
the Raw Data option is selected, the Test list box is

enabled.
Test DM Status
Use this area to select which results are to be sent to the

data manager.
q This area is active only if Result has been selected in

the Data Type area.
All Select this option to send all data to the data manager.
Roche Diagnostics
Send to DM window 1519
Not Sent to DM Select this option to send only results that have not
already been sent to data manager.
Run Type and Test areas
Use this area to select which results are to be sent to the

data manager.
u For more information see Test results list (1507)
1st Select this option to send first run results to the data
manager.
Rerun Select this option to send rerun results to the data

manager.
Chosen Select this option to send results - first run or rerun

selected in the Test Review window - to the data manager.
Test Use this list box to specify a reaction monitor to be sent to

the data manager. This list box is available only if Reaction
Monitor or Raw Data are selected in the Data Type area.
Select the test from the list box whose reaction monitor is
to be sent.
u See Data Type (1518).
Buttons
Send Use this button to start the transmission of the specified

sample results or reaction monitor data to the data
manager.
Close Use this button to close the window without sending any
data to the data manager.
23 Workplace menu
Roche Diagnostics
1520 Backup Data window
Backup Data window

f Workplace > Data Review > Backup Data
Use this window to copy results selected in the sample

selection list on Workplace > Data Review to a special file
format onto a DVD.
q Only data saved in binary format can be restored

using Workplace > Data Review > Read Backup.
u See Read Backup window (1511).
u For more information, see

List of compatible DVD media (619)
Output Use this area to select data and format for backup.
• Data Backup
Use this option to write all data to a storage medium in
binary format. This format cannot be read by other PC
23 Workplace menu
systems but can be restored to the instrument.

• Results (CSV)
Select this option to write patient results to a storage
medium in CSV (comma separated values) format. This
is a flexible format that can be used by other PC
systems, for example, in a spread sheet program, but
cannot be restored to the instrument.
• Reaction Data (CSV)
Select this option to write reaction data to a storage
medium in CSV format. This is a flexible format that can
be used by other PC systems, for example, in a spread
sheet program, but cannot be restored to the
instrument.
Roche Diagnostics
Backup Data window 1521
With Double Quotation Marks Select this option to use double quotation marks as text
separators in the generated CSV file.
File Name Use this text box to define the file name under which the
results are saved. Or: Use the button next to the File Name
text box to display the Save As window and search for an
appropriate folder for the file.
23 Workplace menu
Roche Diagnostics
1522 Test Review window
Test Review window

f Workplace > Data Review > Test Review
Use this window to review, delete and edit test results for
patient samples or to review controls.
Sample Information area
Sample This field displays the sample class (for example, STAT,
Routine, Control) selected on Workplace > Data Review.
Sequence No. This field displays the sequence number of the control
(barcode mode) selected on Workplace > Data Review. It is only displayed
for QC samples.
Sequence No. This field displays the sequence number of the sample or
(non-barcode mode) the control selected on Workplace > Data Review.
23 Workplace menu
Rack No. - Pos. This field displays the rack ID and the position of sample
selected on Workplace > Data Review.
S. Type This field displays the sample material of the sample

Control Lot ID This field displays the control lot number of the sample
Sample ID This field displays the sample ID number of the sample

Status This field displays the sample status. The sample status is
identical to the status on the Data Review submenu.
Roche Diagnostics
Test Review window 1523
Carryover Evasion This field displays the detergents for the special wash (for
example SmpCln1, SmpCln2, or water).
u For more information see Special Wash submenu
(photometric and e 602 tests) (1855)
u See Defining special wash data (751).
Pre-dilution This check box is selected if the sample was defined as pre-
diluted on Workplace > Test Selection.
Test result list
This list shows all tests of the sample or control selected

on Workplace > Data Review. For samples, the list is divided
into 1st Result and Rerun Result.
Select Result In this column, operators can select the result to report, if
both the 1st and rerun results are available. For controls,
only one result is displayed.
• 1st
The 1st result is selected to report.
• Rerun
The rerun result is selected to report.
• No Select
No result is available or no result is selected to report.
Test This column displays the short name of the test.
Result This column displays the test result.
q Values in the Result column can be edited. If a result is

edited, Edited is displayed in the Alarm column
23 Workplace menu
Alarm This column displays any data alarms associated with the
test result.
u See List of data alarms for tests (1159).
R.M. This column displays a result message (r, n or b). The r

(reactive) or n (non reactive) indicates if a test for an
infectious disease (qualitative assay) has a positive or
negative result, respectively. The b indicates that the
result is in a gray zone around cutoff value = 1. This means
no determination regarding reactive or non-reactive
results can be made.
Roche Diagnostics
Dil. This column displays the sample dilution factor used to

produce the test result.

only.



Time This column displays the date and time the test was
sampled.


e 801/e 602 modules

23 Workplace menu
cobas c module.

Roche Diagnostics

HPI requests.
contamination.


manager yet.

manager.
St. This column indicates the status of each test.

pipetted yet.

the data manager.

23 Workplace menu
masked.
Roche Diagnostics

yet.

problems.


- The current reagent cassette has been

used up since the barcode of the QC
sample was read by the core unit. The
QC measurement was performed using
the first standby reagent cassette.
SB1 The first standby reagent cassette after

the currently used reagent cassette

Sampling Pos. (for QC material) This column displays the position of the QC material on the
rack.
23 Workplace menu
Buttons

information as well as the draw date and time for the
current sample. A sample must be selected from the
sample selection list for the Sample Information button to
be active.
Roche Diagnostics
Reagent Detail Choose this button to open the Reagent Detail window.
This window displays detailed information about the
selected test.
u See Reagent Detail window (1528).
Original Data Choose this button to open the Original Data window. This
button is only available for compensated and calculated
tests. Use this window to review details of the first run and
rerun measurement of calculated tests. Use it also to
review supplementary items used for the measuring of
compensated tests.
u See Original Data window (1529)
All Results Choose this button to open the All Results window. This
(for patient samples only) button is only available if samples are shown in the test
result list. Use this window to view all results for a test
selected on the Test Review window.
u See All Results window (1533)
Delete Test Choose this button to delete the selected test results after
(for patient samples only) confirmation.
Update Choose this button when it is highlighted in yellow to

update the data in the Test Result list.
Cancel Choose this button to reset edited data to the original

value before choosing Update.
Previous Use this button to display the test results for the previous
sample.
Next Use this button to display the test results for the next
sample.
23 Workplace menu
Roche Diagnostics
1528 Reagent Detail window
Reagent Detail window

f Workplace > Data Review > Test Review > Reagent Detail
w Reagent Detail window
Use this window to review details of the test results

currently selected in the Test Review window. In the upper
area, the window displays the details for the first result and
in the lower area, for the rerun result measured for the
test.
Analyzed Unit This field displays the analytical unit and the reagent disk
for the test of the selected sample or the measuring
channel on an e 801/e 602.
Sampling Date/Time This field displays the date and time the test was pipetted.
Effective Signal This field appears in an e 801/e 602 test review only; it
displays the effective signal measured.
23 Workplace menu
Used Reagents This field displays the lot number and the sequence
number of the reagent used for the measurement. For
tests performed on an e 801/e 602 module, the ProCell lot
number is also displayed. The position number refers to the
ProCell II M/ProCell M bottle used.
Calibration ID On c 701/c 702 modules and e 801 module, this field

displays the sequence number of the calibration used for
calculating the result.
Roche Diagnostics
Original Data window 1529
Original Data window

f Workplace > Data Review > Test Review > Original Data
Use this window to review details of the first run and rerun
measurement of calculated tests. Use it also to review
supplementary items used for the measuring of
compensated tests.
Processed Data area
This area displays the processed data of the test selected

in the Test Review window
Test This field displays the short name of the test selected in
Test Review window.
1st Result This field displays the 1st test result of the test selected in
Test Review window.
23 Workplace menu
1st Alarm This field displays the alarm associated with the 1st test
result of the test selected in Test Review window.
Rerun Result This field displays the rerun test result of the test selected
in Test Review window.
Rerun Alarm This field displays the alarm associated with the rerun test
result of the test selected in Test Review window.
Roche Diagnostics
1530 Original Data window
Original Data list
Use this list to review the original data of the first run and
rerun measurement. The list is divided into 1st Result and
Rerun Result.
Test This column displays the short name of the test.
test result.



only.

23 Workplace menu


sampled.
Roche Diagnostics
Original Data window 1531


e 801/e 602 modules

cobas c module.


HPI requests.
contamination.

23 Workplace menu
pipetted yet.

the data manager.

masked.
Roche Diagnostics
1532 Original Data window

yet.

problems.

Buttons
selected test.
23 Workplace menu
Roche Diagnostics
All Results window 1533
All Results window

f Workplace > Data Review > Test Review > All Results
Use this window to review all results of a test currently

selected in the Test Review window. Up to 400 results can
be displayed.
Test This field displays the short name of the test.
Unit This field displays the unit (for example, g/L or U/L) of the
test for the selected sample.
Result list
Use this list to review all results of a test currently selected

in the Test Review window. Up to 400 results can be
displayed. 23 Workplace menu
Run This column displays the sequence of measurements.
test result.

Roche Diagnostics
1534 All Results window


only.



sampled.


e 801/e 602 modules

23 Workplace menu
cobas c module.

Roche Diagnostics
All Results window 1535

HPI requests.
contamination.

pipetted yet.

the data manager.

masked.

yet.

23 Workplace menu
problems.

Roche Diagnostics
1536 All Results window
Buttons
selected test.
Original Data Choose this button to open the Original Data window. This
button is only available for compensated and calculated
tests. Use this window to review details of the first run and
rerun measurement of calculated tests. Use it also to
review supplementary items used for measuring of
compensated tests.
u See Original Data window (1529)
23 Workplace menu
Roche Diagnostics
Reaction Monitor window

f Workplace > Data Review > Reaction Monitor

test for the selected sample. The graph displayed
represents the sample and test selected on the Data
Review submenu. Both the original and rerun results for
patient samples can be viewed. Different tests for the
selected sample may be viewed using the Test list box.
Upper area
Test Use this list box to select the test to be displayed on the
graph. The test selected on the Data Review submenu is
automatically displayed. Select the desired test from the
list box.
Run Type The Run Type options are only available for Routine or
23 Workplace menu
STAT samples.
• 1st
Select this option to view the reaction graph for the
results from the first run of the specified test.
• Rerun
Select this option to view the reaction graph for the
results from the rerun of the specified test.
Scale This field displays the scale, Automatic or Manual, selected

on the Scale Setting window.
Roche Diagnostics
1538 Reaction Monitor window
Graph area
This area displays the graph of the selected test.
Arrow buttons Use the arrow buttons at the left and right side below the
graph to move to and display the information for the
selected point.
Reaction information
This area displays detailed information for the selected

test.
Point This column shows the individual measuring point selected

in the graph.
Abs. This column displays the absorbance value for the

measuring point displayed in the Point column and selected
on the graph.
Conc. This column displays the result (concentration) of the

selected test.
Prozone This column displays the prozone check value.
Limit This column displays the calculated, sample-specific

absorbance limit. The absorbance limit is used for the
calculation of the reaction limit check data alarm (>React).
u About the reaction limit check (>React) (1999)
Cell No. This column displays the reaction cell number where the
reaction took place.
23 Workplace menu
Run Type This column displays the run type (1st or Rerun).
(for routine and STAT samples)
Reagent Status This column displays a reagent’s status of precedence.

(for QC material) Possible values are Current, SB1, SB2, SB3 …
Current Reagent currently in use

current is named SB1

is named SB2
Roche Diagnostics
The order of precedence of standby reagents within the

same lot is assessed by the reagents’ time of registration;
the oldest reagent is used first.
Reagent This column displays the reagent type (R1–R3).
R. Pack Lot ID This column displays the lot number of the reagent
cassette.
R. Pack Seq. No. This column displays the sequence number of the reagent
cassette.
Buttons
Scale Choose this button to display the Scale Setting window.

Use the Scale Setting window to define the lower and upper
limits of the absorbance range shown on the Y-axis of the
graph. This window is described in detail later in this
section.
u See Scale Setting window (1540).
Overlay Choose this button to display the Overlay window. Use the
Overlay window to select up to 5 samples or controls for a
specified test. The reaction graphs then overlay each
other and display on the Reaction Monitor window. This
window is described in detail later in this section.
u See Overlay window (1541).
Send to Host Choose this button to display the Send to DM window. Use
the Send to DM window to send reaction monitor data to
the data manager. This window has already been described
in detail earlier in this section.
u See Send to DM window (1518).
23 Workplace menu
Roche Diagnostics
1540 Scale Setting window
Scale Setting window

f Workplace > Data Review > Reaction Monitor > Scale
Use the Scale Setting window to define the lower and upper
limits of the absorbance range that is shown on the Y-axis
of the graph.
Automatic Select this option to allow the system to automatically set

the scale.
Manual Select this option to set the scale manually. Setting the
scale manually improves the resolution of the graph.
Type the value of the lower limit of the scale (-10 000 to
40 000) in the first text box. Type the value of the upper
limit of the scale (-10 000 to 40 000) in the second text
box.
23 Workplace menu
Roche Diagnostics
Overlay window 1541
Overlay window
f Workplace > Data Review > Reaction Monitor > Overlay
Use the Overlay window to select up to 5 samples for a

specified test. The reaction graphs then overlay each
other and display on the Reaction Monitor window.
This window is useful for comparing reaction curves of up

to 5 samples or controls for a specific test. The results can
assist in troubleshooting potential system or sample
problems by showing the relationship of results from one
sample or control to another for a given test.
u For more information about selecting samples in the
Overlay window, see: Selecting samples to compare the
reaction curves (1242)
Test This field displays the name of the test for which reaction
23 Workplace menu
graphs are being selected for overlay.
Roche Diagnostics
1542 Overlay window
Upper list
Use this list to select a sample to be added to the lower list.

Select a symbol in the lower list. Choose the Add button to
add this sample to the lower list. The symbol is displayed in
the upper list in the column Assort. You can choose up to
5 samples to overlay by selecting a new symbol for each
sample.
Assort This column displays 5 different symbols for the samples to

overlay in the Reaction Monitor window.
Rack No. - Pos. This column displays the rack ID number and position on
the rack of the sample selected for overlay.
Sample ID This column displays the patient ID of the sample selected

for overlay.
S. Type This column displays the sample type (Ser/Pl, Urine, CSF,
Suprnt or Other) of the sample selected for overlay.
Run Type (for routine and STAT samples) This column displays the run type of the selected sample.
Reagent Status (for QC material) This column displays a reagent’s status of precedence.
Possible values are Current, SB1, SB2, SB3 …
Sampling Date/Time This column displays the time when the sample passed the
barcode reader.
Lower list
This list contains the same columns as the upper list. Use
23 Workplace menu
this list to select a symbol to be added to a sample in the

upper list.
You can choose up to 5 samples to overlay by selecting a

new symbol for each sample. The lower list assigns a
symbol to the reaction graph for interpretation on the
Reaction Monitor window.
Roche Diagnostics
Overlay window 1543
Buttons
Add Use this button to add a sample selected from the upper
list to the lower list. Choose the desired symbol in the lower
list. Choose the desired sample in the upper list, then
choose the Add button to add the sample to the lower list.
Repeat up to 4 times.
Once the sample is added to the lower list, the symbol is

also displayed in the upper list.
Remove Use this button to remove a sample listed in the lower list.
Choose the desired sample in the lower list, then choose
the Remove button to delete the sample from the lower list.
The symbol is also removed from the sample in the upper

list.
23 Workplace menu
Roche Diagnostics
1544 Calib. Review submenu
Calib. Review submenu

f Workplace > Calib. Review
Use this submenu to review the status of the calibrators

used during operation. Select the calibrator in the left list
to review the status of the calibrations performed for each
test.
The data displayed on this submenu is automatically

deleted when the instrument is powered off. The data is
updated every 5.4 s.
During Standby, it is possible to delete a calibrator with the

Delete Calibrator button or a calibration test with the
Delete Test button.
u About the Calibration Review submenu (601)
u For information about the calibration workflow, see:
23 Workplace menu

Calibration (465)
Calibrator selection list
The list on the left side of the screen displays the

calibrators registered by the system. Up to 100 calibrators
can be registered. The list can be sorted by Rack No.-Pos.
or by Calibrator.
q The width of the individual columns can be adjusted by

clicking the column dividers in the column header and
dragging them to the left or right.
Roche Diagnostics
Calib. Review submenu 1545

calibrator (barcode was already read).
At least one calibration is running for the
calibrator.
F (Failed) At least one calibration performed with

this calibrator could not generate a valid
calibration result.
S (Successful) Calibrator successfully processed. All

calibrations performed with this
calibrator have generated valid
Rack No. - Pos. This column displays the rack number and position within
the rack of the particular calibrator. The calibrator position
on the rack is only displayed in case of ISE or photometric
tests.
Calibrator This column displays the name of the calibrator.
Test results list
The list on the right side of the screen displays details of

the tests performed with the calibrator currently selected
in the list on the left. Only the last calibration for each test
is shown.
q If a calibration for the same test and for the same

reagent is measured again, the information in the row of
this test will be overwritten.
St. The St. column displays the calibrator status codes: 23 Workplace menu
No character The calibration measurement was not
successfully performed so far.
Calibration might be canceled, for
example, as a result of a sample clot or
not enough sample.

calibrator (barcode was already read)
and at least one calibration is requested
for this calibrator. If the calibrator has
already been pipetted by the module, a
pipetting date and time is available.
F (Failed) No valid calibration has been generated

for the test.
S (Successful) A valid calibration has been generated

for the test.
Roche Diagnostics
1546 Calib. Review submenu
Test This column displays the test name processed for the
currently selected calibrator.
For ISE tests, this column displays the ISE type (ISE-A or
ISE-B).
Pip. Time This column displays the latest pipetting date and time of
the test if the calibrator has already been pipetted. The
The date and time are updated by each new pipetting of
the calibrator.
cassette used for the test. For ISE tests, no information is
displayed.
cassette used for the test. For ISE tests, no information is
displayed.
Reagent Status This column displays the status (Current or stand by SB1,
SB2, …) of the reagent used for the test. This information is
updated if the calibration for the reagent cassette is
measured again and the status is changed (e.g., from SB to
Current).
For ISE tests, no information is displayed.
Calib. Type This column displays the calibration type: Lot for a lot
calibration or R.Pack for a reagent cassette calibration. For
ISE tests, no information is displayed.
23 Workplace menu
Buttons
The deletion of data may be useful after a change of the

calibrator lot or if you need room for additional calibrators.
Delete Calibrator Use this button to delete any calibrator selected in the
calibrator selection list.
Delete Test Use this button to delete any test of a calibrator selected
in the test result list.
Roche Diagnostics
1547
Table of contents
Reagent menu 24
Use the Reagent menu to view detailed reagent information

and to register loaded reagents. This menu consists of two
submenus, the Setting and the Status submenu.
In this chapter 24
Setting submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1549
Abbreviations of reagents. . . . . . . . . . . . . . . . . . . . . . . . 1556
Reagent Registration window. . . . . . . . . . . . . . . . . . . . . 1558
Reagent Prime window . . . . . . . . . . . . . . . . . . . . . . . . . . 1560
Manual Registration (C Module) window . . . . . . . . . . . . 1563
R. Pack Set Information window (c 702/c 701 module) 1564
R. Pack Set Information window (e 801 module) . . . . . 1566
R. Pack Unloading window (c 702 module). . . . . . . . . . 1567
R. Pack Unloading window (c 502 module). . . . . . . . . . 1568
R. Pack Unloading window (e 801 module). . . . . . . . . . 1569
Development Channel window . . . . . . . . . . . . . . . . . . . . 1570
Status submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1572
24 Reagent menu
Inventory Set window. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1578
Roche Diagnostics
1548
Table of contents
24 Reagent menu
Roche Diagnostics
Setting submenu 1549
Setting submenu
f Reagent > Setting
w Setting submenu for a cobas c module
24 Reagent menu
Roche Diagnostics
1550 Setting submenu
w Setting submenu for the e 801 module
Use the Setting submenu to view details of reagents

currently loaded on the modules. The compiled data
include reagent code, lot number, expiry date (shelf life) as
well as the onboard stability of the reagents (in days). The
buttons at the bottom of the screen allow you to register
newly loaded reagents or to execute a reagent prime, for
example.
u For information about the reagents used and loading
the reagents onto the modules, see:
Module list box Use this list box to select the module. Only reagents on the
specified module will be displayed in the Setting list.
Including Reagent Manager check box (c 702 Select this check box if the reagent cassettes present on
only) the buffer rotor should be taken into account when
displaying the Setting submenu. In this case the number of
tests or the volume available are added to the total
24 Reagent menu
number of tests or total volume available on the selected

module.
Setting list
This list displays information about all reagents on the

module selected in the Module list box. The list is sorted by
the Position column and then by the Test column. It can
NOT be sorted in other manners by clicking on column
headers.
Roche Diagnostics
Mark This column displays information related to the reagent

registration.
An asterisk (*) indicates manually registered reagents

which are used for Development Channel applications.
For c 702 and e 801 modules only: A minus sign (-)

indicates that the reagent cassette is reserved for
unloading.
For e 801 modules only: An at sign (@) indicates that the

test is a linked test or that the test and the reagent
cassette are part of a linked kit.
u For more information on manually registered reagents,
see:
module (334)
module (363)
module (382)
Position This column displays the reagent positions on the module

currently selected in the Module list box. On c 701/c 702
modules, the positions A-1 to A-35 refer to the left reagent
disk, while B-1 to B-35 refer to the right reagent disk.
On c 702 modules only, M-1 to M-10 refers to the reagent

manager.
Test This column displays the short test name of the reagent
currently loaded in the corresponding reagent position.
A question mark appears in this column if a reagent was

registered by the RFID or barcode reader and the
application parameters are not on the instrument.
For ISE modules, ISE1 or ISE2 are displayed in the Test

column to indicate ISE applications and the ISE unit.
The test names may be highlighted with colors to indicate

24 Reagent menu
low reagent levels.

u For information on the color scheme in the Test column,
see:
Color scheme of Setting and Status submenus (1553).
Available Tests This column displays the total number of tests available for
all reagent cassettes of a specific test which are currently
loaded on the module.
The number in parentheses (if present) represents the level
set for the purple alarm.
If no reagent is available for this test, a red “0” is displayed

in this column.
Roche Diagnostics
Masked reagent cassettes are taken into account for the

number of Available Tests. If all reagent cassettes for a
test are masked, a red “0” is displayed in this column.
q While the column Remaining displays the number of

tests remaining for a single reagent cassette, the column
Available Tests displays the sum of tests available for all
reagent cassettes of the same test currently loaded on the
module.
u For information about setting the alarm levels, see

Reagent Level window (1729).
Type This column displays the type of reagent. The type of

reagent depends on the module selected in the Module list
box. For photometric modules, the pipetting time points
R1/R2/R3 are displayed.
u See Abbreviations of reagents (1556)
u For more information on the pipetting time points on
photometric modules, see:
Specifications of the reagent system of cobas c
modules (2018)
Remaining This column displays the number of tests remaining for a

single reagent cassette. For diluents and system reagents,
the remaining volume is displayed.
R. Pack ID This column displays the reagent code of the reagent in

the corresponding position. The reagent code is also
printed on the reagent cassette as System-ID.
cassette.
u Priority of reagent cassettes (406).
cassette.
Exp. Date This column displays two expiry dates: The first one
24 Reagent menu
displays the expiry date (shelf life) of the reagent in the

The second one (number in parentheses) displays the
onboard stability of the reagent (in days).
Roche Diagnostics
The expiry date is displayed in red if the onboard stability

time has been exceeded (indicated by a red (0)), or if the
shelf life has expired (indicated by a red bar).

B u Expired reagents or mixing reagents
u For more information about the onboard stability, see:
A Analyze (photometric tests) (1819).
A Shelf life of reagent B Onboard stability
expired (ReagEx flag exceeded on reagent
attached to result) disk (OBS.RR flag
attached to result)
Color scheme of Setting and Status submenus
The following colors are used on the Reagent submenus to

indicate low reagent levels:
A reagent, diluent, or pretreatment is empty on this

module. The corresponding tests cannot be performed
(reagent masking) until the reagent is loaded.
For cobas e modules: An assay or pretreatment reagent
cassette could not be linked to the required partner
reagent cassette (link status Free). Partner reagent is not
on board.
For e 801 modules only: The required second reagent
cassette of a linked kit is not on board.
The number of tests remaining for a reagent is less than

the yellow alarm level. Levels are defined in Utility
> System > Reagent Level.
For c 702 only: Reagent cassettes on the buffer rotor are
taken into account when calculating the remaining
reagent of a test. If the total remaining reagent on a
reagent disk or on the entire module is lower than the
yellow limit, a yellow alarm is issued.
The number of tests remaining for a reagent is less than

the purple alarm level (daily requirement). Only applicable
24 Reagent menu
if the Preventive Action check box on the Overview menu

is selected.
The amount of reagent on this module is sufficient.
Roche Diagnostics
The reagent alarm levels can be programmed separately

for each reagent. The levels are defined in Utility > System
> Reagent Level (administrator access required). A red
alarm for tests can be activated with the Mandatory check
box in Utility > System Configuration > Test Assignment.
u For information on reagent level check alarm settings,
see:
Reagent Loading Level window (c 702) (1741)
Buttons
Reagent Manager Overview (c 702 module) Use this button to display the Reagent Manager Overview
window and view the status of the reagents loaded on the
buffer rotor of the reagent manager. The Reagent Manager
Overview window belongs to the module selected in the
Module list.
u See Reagent Manager Overview window (c 702
module) (1320)
Reagent Registration (c 701/c 702 module) Use this button to start registering reagents after new
cobas c packs have been loaded. During reagent
registration, the module scans the cobas c pack’s
identification number (RFID tag) and performs a liquid level
detection.
u See Reagent Registration window (1558).
Reagent Prime (ISE, e 801, e 602 module) Use this button to prime the reagents either of ISE modules
(ISE Internal Standard, ISE Diluent, ISE Reference
Electrolyte), of the e 801 modules (ProCell II M,
CleanCell M, PreClean II M), or of e 602 modules
(ProCell M, CleanCell M, PreClean M).
u For more information on the system reagents, see:
24 Reagent menu
Manual Registration (c 701) Use this button to enter a reagent cassette’s identification
number manually. This is required for Development
Channel applications on c 701 modules.
u See Manual Registration (C Module) window (1563).
Reagent Volume Reset (ISE, c 701/c 702, and Use this button to reset the remaining volume after
c 502 modules) replacement of ISE reagents or photometric system
reagents.
A confirmation window appears. Choose Yes to reset the

remaining volume of the selected reagent. Choose No to
close the window without resetting.
Roche Diagnostics
Delete (c 701 module) Use this button to delete a reagent manually to remove it
from the instrument. This is only required for manually
registered reagents.
A confirmation window appears. Choose Yes to delete the

selected reagent. Choose No to close the window without
deleting.
R. Pack Set Information (c 701/c 702 and e 801 Use this button to display information about the selected
module) reagent or set of reagent cassettes. For the
c 701/c 702 modules, the R. Pack Set Information window
can also be used to break up empty reagent kits before
removal from the reagent disk.
u See R. Pack Set Information window (c 702/c 701
module) (1564)
R. Pack Set Information window (e 801 module) (1566).
R. Pack Unloading (c 702, c 502, and e 801 Choose this button to unload a reagent cassette.
module)
u See R. Pack Unloading window (c 702 module) (1567)
R. Pack Unloading window (c 502 module) (1568)
R. Pack Unloading window (e 801 module) (1569).
Development Channel (c 702 and c 502 Use this button to reserve test applications for
module) Development Channels on c 702 or c 502 modules.
u See Development Channel window (1570).
24 Reagent menu
Roche Diagnostics
1556 Abbreviations of reagents
Abbreviations of reagents
The following names and abbreviations are used for the
reagent types in the software:
Module Name or abbreviation in user Description

interface
ISE IS Internal standard solution for ISE unit 1/2
DIL Diluent for ISE unit 1/2
REF Reference solution KCL for ISE unit 1/2
SmpCln 1 Sample probe wash solutions (SmpCln1 = basic wash,
SmpCln 2 SmpCln2 = acid wash)
ECO-D ECO-D (surfactant for the incubation bath)
(for ISE support box)
c 701/c 702/c 502 R1, R2, R3 Test reagent; the number stands for the pipetting time-point
(R1, R2, or R3)
CellCln 1 Cell wash solutions (CellCln1 = NaOH-D, CellCln2 = acid wash)
CellCln 2
D1 (NAOHD) Detergent/NaOHD for washing the reagent probes and reaction
cells when using maintenance action (7) Wash Reaction Parts
and if programmed for special washes
D2 (SMS) Detergent/SMS for washing the reagent probes if programmed
for special washes
D3 (SCCS) Special Cell Cleaning Solution for c 502 modules
DIL (NACL) Diluent/NaCl
ECO-D ECO-D (surfactant for the incubation bath)
SmpCln1 Sample probe wash solutions (SmpCln1 = basic wash,
SmpCln2 SmpCln2 = acid wash)
SPR Special reagent (c 701/c 702 only), can be used by multiple
applications as third reagent
e 801/e 602 ASSAY Assay reagent cassette (current or standby)
DIL Diluent reagent cassette
PRE Pretreatment reagent cassette
Magazine Full magazine with AssayTips and AssayCups
MagWaste Empty magazines
SolidWaste (Waste) Solid waste containers (WasteLiner) for used AssayTips and
AssayCups
e 801 ProCell (PC) ProCell II M bottles 1 and 2: Signal generating buffer for the ECL
24 Reagent menu
detection
CleanCell (CC) CleanCell M bottles 1 and 2: Wash solution for measuring cells
after measurement also used as wash solution for the reagent
probe to prevent carryover
PreClean PreClean II M bottles 1 and 2: Wash solution for microbeads (for
certain assays only)
y Reagent types
Roche Diagnostics
Abbreviations of reagents 1557
Module Name or abbreviation in user Description

interface
e 602 ProCell (PC) ProCell M bottles 1 and 2: Signal generating buffer for the ECL
detection
CleanCell (CC) CleanCell M bottles 1 and 2: Wash solution for measuring cells
after measurement
PreClean PreClean M bottles 1 and 2: Wash solution for microbeads (for
certain assays only
ProbeWash ProbeWash M bottles 1 and 2: Wash solution for the reagent
probes to prevent carryover
y Reagent types
24 Reagent menu
Roche Diagnostics
1558 Reagent Registration window
Reagent Registration window

f Reagent > Setting > Reagent Registration
This window is used to perform reagent registration. The

actions performed by the system depend on the selected
module. As a result, reagents are ready for calibration.
Reagent registration c 701 module For the c 701 module, reagent registration includes the
following steps:
• The RFID tags of the manually loaded reagent
cassettes are read and the availability of the
corresponding test applications and reagent container
files is checked. The reagent container files are stored
on the data manager. Reagents are only accepted if
the information on the RFID tag matches the
information in the corresponding reagent container file.
• The reagent probes perform a liquid level detection and
foam detection for each reagent bottle.
If reagent cassettes are loaded during Standby mode,

24 Reagent menu
reagent registration must be started manually. If

registration was not started manually, it will be performed
automatically during Preparation mode. Only successfully
registered reagent cassettes are displayed on Calibration
> Status and can be calibrated.
u Changing reagent cassettes on the c 701 module (330)
Roche Diagnostics
Reagent Registration window 1559
Reagent registration c 702 module On the c 702 module, if reagent cassettes are loaded
during Operation mode, the reagent manager
automatically registers the new reagent cassettes, the
reagent cassette gripper transfers the reagent cassettes
to the reagent disks, and the reagent probes automatically
perform the following checks:
• Liquid level detection and foam detection for each
reagent bottle on a new reagent cassette.
If the reagent cassettes are loaded during Standby mode,

observe the following:
• If you start operation after loading reagent cassettes,
reagent registration will be performed automatically
during Preparation or Operation mode.
• If you perform a maintenance item that requires
reagents (e.g., (5) Incubation Water Exchange) after
loading reagent cassettes, you must start the reagent
registration either manually or by a maintenance pipe.
New reagent cassettes are displayed on Calibration

> Status and are thus available for calibration after reagent
registration has been performed.
u Loading reagent cassettes on the c 702 module (349)
24 Reagent menu
Roche Diagnostics
1560 Reagent Prime window
Reagent Prime window

f Reagent > Setting > Reagent Prime
f Reagent > Status > Reagent Prime
f Overview > Reagent Preparing > Reagent Prime
This window is used to initiate a reagent prime on the

selected modules. Performing a prime ensures no air is in
the reagent tubing.
For ISE module: Reagents are primed according to the

option chosen (default: ALL option, 20 cycles). Reagent
consumption 400 µL per cycle.
For e 801, e 602 modules: Pre-wash option: The flow path

from the PreClean aspiration tubing to the PreClean supply
nozzle and pre-wash sipper nozzle is primed. Reagent
option: The flow paths from the ProCell and CleanCell
aspiration pipes to the supply nozzles are primed. The
PC/CC cups are refilled. On e 801 modules, the flow path
from the CleanCell aspiration pipes to the reagent probes
24 Reagent menu
rinse station is also primed.
Roche Diagnostics
Reagent Prime window 1561
q Whenever you replace any ISE reagent container, a

reagent volume reset, a reagent prime, and an ISE
calibration must be carried out. After cleaning the reagent
aspiration filters, a reagent prime is also required.
u Performing a reagent prime on the ISE module (321)

module (856)
u Cleaning ProCell/CleanCell supply nozzles and
replacing PC/CC cups of the e 801 module (1062)
replacing PC/CC cups of the e 602 module (1110)
ISE area
The ISE area allows selection of the ISE module and the ISE
reagent to be primed.
ISE Module Select a single ISE unit to be primed, or both units.
Prime Item Select the type of prime to be performed.

• IS: ISE Internal Standard
• DIL: ISE Diluent
• IS+DIL: Internal standard and diluent
• Ref: ISE Reference Electrolyte
• All: All ISE reagents
Cycles Enter the number of reagent prime cycles. For all ISE items
20 cycles are recommended.
e 801 area
e 801 Prime Item Select the system reagent that is to be primed.

• Pre-wash: Select this option to prime the flow path from
the PreClean aspiration tubing to the PreClean supply
24 Reagent menu
nozzle and pre-wash sipper nozzle.

• Reagent: Select this option to prime the flow path from
the ProCell and CleanCell aspiration pipes to the
supply nozzles. The PC/CC cups are refilled. The flow
path from the CleanCell aspiration pipes to the reagent
probes rinse station is also primed.
Roche Diagnostics
1562 Reagent Prime window
Cycles Use this text box to enter the number of reagent prime
cycles (1 to 10) and the number of pre-wash sipper cycles
to be performed. For e 801 modules, 1 cycle is sufficient
for finalization or other normal priming purposes. Within
extended power OFF/ON procedures, 5 cycles are
recommended.
off (270)
17 days (628)
17 days (632)
Comment Use this text box to enter a comment regarding the

execution of this maintenance item. Information entered
here appears on the Maintenance Report.
e 602 area
e 602 Prime Item Select the system reagent that is to be primed.

• Pre-wash: Select this option to prime the flow path from
the PreClean aspiration tubing to the PreClean supply
nozzle and pre-wash sipper nozzle.
• Reagent: Select this option to prime the flow path from
the ProCell and CleanCell aspiration pipes to the
supply nozzles. The PC/CC cups are refilled.
Cycles Use this text box to enter the number of reagent prime
cycles (1 to 9999) and the number of pre-wash sipper
cycles to be performed. For e 602 modules, 1 cycle is
sufficient for finalization or other normal priming purposes.
Within extended power OFF/ON procedures, 5 cycles are
recommended.
off (270)
17 days (628)
24 Reagent menu
17 days (632)
Comment Use this text box to enter a comment regarding the

execution of this maintenance item. Information entered
here appears on the Maintenance Report.
Roche Diagnostics
Manual Registration (C Module) window 1563
Manual Registration (C Module) window

f Reagent > Setting > Manual Registration
This window is used to manually register reagents for

Development Channel applications. On the Reagent
> Setting submenu, the position of a manually registered
reagent is indicated with an * symbol in the Mark column.
The reagent information, such as Test Name and Position,

must have been registered manually before the
cobas c pack MULTI can be loaded onto the module.
u For more information on manual registration on the
c 701 module, see:
module (334)
Position This is the position for the reagent selected on the Reagent
> Setting submenu.
Test Choose this list box to select the short test name of the
reagent to be registered.
Type Choose this list box to select the type of reagent in the
reagent cassette. For c 701/c 502 modules, the pipetting
times R1/R2/R3 are selected.
u For more information on the pipetting time points, see:
Overview of the photometric analysis workflow on the
c 701 and c 702 modules (1900).
24 Reagent menu
Roche Diagnostics
1564 R. Pack Set Information window (c 702/c 701 module)
R. Pack Set Information window

(c 702/c 701 module)
f Reagent > Setting > R. Pack Set Information
This window is used to display information about the

selected reagent cassette. If this reagent cassette is part
of a reagent kit, the other reagent cassette is also
displayed. It shows their position on the disk, their ID and
lot number, sequence number, expiry date, and onboard
stability.
u For more information on breaking-up a reagent kit, see:
Reagent kits (327)
Changing reagent cassettes on the c 701
module (330).
Manually selecting reagent cassettes for unloading
R. Pack Set Grouped If the reagent for a test is provided in separate reagent
cassettes, they are grouped together into a set called
reagent kit.
Type This column displays the type of reagent in this reagent

cassette. For c 701/c 702 modules, the pipetting time
points R1/R2/R3 are displayed.
u For more information on the pipetting time points, see:
Overview of the photometric analysis workflow on the
c 701 and c 702 modules (1900).
Position This column displays the reagent positions on the module.
R. Pack ID This column displays the reagent code of the reagent in

the corresponding position. The reagent code is also
printed on the reagent cassette as System-ID.
cassette.
24 Reagent menu
cassette.
Exp. Date This column displays two expiry dates: The first one is the
expiry date (shelf life) of the reagent in the corresponding
position.
The second one (number in parentheses) indicates the

time has been exceeded (indicated by a red (0)) or if the
Roche Diagnostics
R. Pack Set Information window (c 702/c 701 module) 1565
Button
Break Up Use this button to split the set before removing one
reagent cassette from the instrument, e.g. when foam was
detected in one reagent cassette.
A confirmation window appears. Choose Yes to delete the

set and to remove the reagent cassettes. Choose No to
close the window without deleting.
q After breaking-up, the number of available tests for

these reagent cassettes is set to zero (0). The reagent
cassettes must be removed.
24 Reagent menu
Roche Diagnostics
1566 R. Pack Set Information window (e 801 module)
R. Pack Set Information window (e 801

module)
f Reagent > Setting > R. Pack Set Information
If a reagent cassette is part of a linked kit or linked test,

this window displays information about the selected
reagent cassette and its partner reagent cassettes. The
window shows their position on the reagent disk, their lot
number, sequence number, expiry date, and onboard
stability.
Module This field indicates the module on which the linked kit or
linked test is located.
Status This field indicates the link status of this reagent cassette
configuration, either Complete or Incomplete.
Test Name This column displays the test names of the reagent
cassette and its partner reagent cassettes.
Position This column displays the reagent positions on the module.
Type This column displays the type of reagent in this reagent

cassette. For e 801 modules, only pretreatment and assay
reagent cassettes are displayed.
cassette.
cassette.
24 Reagent menu
position.

Roche Diagnostics
R. Pack Unloading window (c 702 module) 1567
R. Pack Unloading window (c 702 module)

f Reagent > Setting > R. Pack Unloading
This window is used to unload reagent cassettes from the

reagent disks. Empty reagent cassettes are unloaded
automatically from the c 702 module. Therefore, this
window is either used to unload filled reagent cassettes, or
all reagent cassettes.
u For information about unloading procedures, see:
Manually selecting reagent cassettes for unloading
Select R. Pack Select this option to transfer the selected cobas c pack to
the unloading tray. This option is used to unload a reagent
cassette that contains remaining reagent.
All R. Pack Select this option to transfer all cobas c packs to the
unloading tray.
24 Reagent menu
Roche Diagnostics
1568 R. Pack Unloading window (c 502 module)
R. Pack Unloading window (c 502 module)

This window is used to unload reagent cassettes from the

reagent disk, either via the loading port or to the reagent
cassette disposal.
Unload Select this option to unload the reagent cassette via the
loading port. Wait at least 5 seconds after the reagent
cassette was pushed out of the loading port before you
place any reagent cassette into the port.
Dump Select this option to discard the reagent cassette, so that

you cannot register it again. The reagent cassette is sent
to the reagent cassette disposal.
q If you use the option Dump for unloading a reagent

cassette, it cannot be reloaded.
u For information about unloading reagent cassettes,

see:
module (380).
Pos. This field displays the position of the selected reagent

cassette on the corresponding module.
Test This field displays the test selected on the Reagent >
Setting submenu.
R. Pack Lot ID This field displays the lot number of the selected reagent
24 Reagent menu
cassette on the module.
Roche Diagnostics
R. Pack Unloading window (e 801 module) 1569
R. Pack Unloading window (e 801 module)

This window is used to manually unload selected or all

reagent cassettes which are not unloaded automatically
from the reagent disk.
The instrument automatically selects reagent cassettes

for unloading under the following conditions:
• Reagent cassettes in which foam or air bubbles were
detected
• Reagent cassettes in which evaporation was detected
during the initial volume check
• Expiry masked reagent cassettes
Select R. Pack Select this option to select the reagent cassette for
unloading. This option is used to unload a reagent cassette
that contains remaining reagent.
All R. Pack Select this option to select all reagent cassettes for
unloading.
24 Reagent menu
Roche Diagnostics
1570 Development Channel window
Development Channel window

f Reagent > Setting > Development Channel
w Development Channel window (c 702 and c 502 module)
This window is used to assign a cobas c pack MULTI to an

already installed development channel application (open
channel). This must be done before loading the
corresponding cobas c pack MULTI.
u For information on loading a cobas c pack MULTI, see:
module (363)
module (382).
For development channel applications,

cobas c pack MULTI are available. The cobas c pack MULTI
is an empty reagent cassette, labeled with a development
channel barcode.
Since the same development channel barcode is used for

all development channel applications, the
cobas c pack MULTI has to be assigned to a development
channel application before loading onto the analyzer.
24 Reagent menu
q A description for loading Development Channel

applications is available on cobas® link. Refer to the
Instructions for Use for the cobas c pack MULTI. Please
contact your technical support for more information.
Table of Development Channel applications
The table displays all test and diluent informations of the

development channel applications installed on the
analyzer.
Roche Diagnostics
Development Channel window 1571
Test This column displays the name of the test or DIL for diluent.
App. Code This column displays the application code of the test or the
diluent.
Type (c 702 only) This column displays the reagent type of the test or the
diluent.
Status This column displays the status of the development

channel application:
• Reserved
If you choose the Reserve button, the selected test is
reserved for the next cobas c pack MULTI that is loaded
on the analyzer.
• Assigned
If you then load a cobas c pack MULTI, it is assigned to
the reserved test.
Buttons
Reserve Choose this button to reserve a test. If you then load a

cobas c pack MULTI, it is assigned to the reserved test.
Delete Choose this button to cancel a development channel

reservation.
24 Reagent menu
Roche Diagnostics
1572 Status submenu
Status submenu
f Reagent > Status
B
A
A Test list C Inventory list: System reagents and consumables provided in

bottles or containers
B R. Pack list: Reagents provided in reagent cassettes
Use the Status submenu to view the status of the reagents

currently loaded on the instrument. The data is sorted
according to the names of the applications and displayed
either for all modules or for one specified module.
Moreover, there is an additional list, which provides
information about system reagents.
u For information on colors and abbreviations used in the
submenu, see:
Color scheme of Setting and Status submenus (1553)
Abbreviations of reagents (1556).
u For information about resetting the reagent volume,
24 Reagent menu
see:
module (324)
module (337)
module (340)
Roche Diagnostics
Status submenu 1573
Module list box Use this list box to select a module or all modules for which
the available tests are to be displayed in the test list.
Including Reagent Manager check box (c 702 Select this check box if the reagent cassettes that are
only) present on the buffer rotor should be taken into account
when displaying the Status submenu. In this case the
number of tests or the volume available are added to the
total number of tests or total volume available on the
selected module.
Lists on the Status submenu The three lists provide the following information:
• Test list: Displays all tests and system reagents (in
reagent cassettes) that are currently loaded on the
selected module and the total number of tests or
volume available (sum of all reagent cassettes for each
test).
• R. Pack list: Displays reagent details of the test
currently selected.
• Inventory list: Displays the statuses of ISE reagents,
system reagents (in bottles), and consumables (such as
AssayCup and AssayTip magazines).
Test list
Use this list in the left pane of the Reagent > Status
submenu to select a test whose reagent details are to be
displayed in the R. Pack list.
This list can be sorted by Test Name or Available Tests by

choosing the appropriate column header. An arrow in the
column and sorting order.
Test This column displays the short test name. The test names
may be highlighted with colors to indicate low reagent
levels.
u For information on the color scheme in the Test column,
see:
24 Reagent menu
Color scheme of Setting and Status submenus (1553).
Available Tests This column displays the total number of tests or volume
available on the selected module (Module list box). The
second number in parentheses (if displayed) represents
the level set for the purple alarm.
For example, 248(310): 248 tests are available on the

module, the purple alarm level is set to 310 tests.
When no reagent is available for the test, a red (0) is

displayed in this column. This is also applied if all reagent
cassettes for a test are masked.
Roche Diagnostics
1574 Status submenu
q The number of available tests is the sum of all

remaining tests of reagent cassettes or containers for the
specified test currently loaded on the module.

Reagent Level window (1729).
R. Pack list
Use this list in the upper right pane of the Reagent > Status
submenu to view details about the reagents loaded on the
instrument. The details displayed here correspond to the
test currently selected in the Test list.
Module This column displays the module on which the reagent is

loaded.
Type This column displays the type of reagent. The type of

reagent depends on the module selected in the Module list
box. For c 702/c 701/c 502 modules, the pipetting time
points R1/R2/R3 are displayed.
u For information on the abbreviations used, see:
Position This column displays the position of the respective reagent

on the reagent disk.
Remaining Depending on the type of reagent, this column displays the

remaining number of tests or the remaining reagent
volume.
• If a reagent is selected, the number of remaining tests
is displayed.
• If a diluent or detergent is selected, the remaining
volume is displayed.
position.
24 Reagent menu


u For more information about the onboard stability, see:
Analyze (photometric tests) (1819).
Roche Diagnostics
Status submenu 1575
Inventory list
Use this list in the lower right pane of the Reagent > Status
submenu to view the system reagents, solid consumables
and waste levels of the module currently selected in the
Module list box.
Module This column displays the module on which the system

reagents and consumables are loaded.
Type This column displays the type of reagent or consumables.

u For information on colors and abbreviations used in the
submenu, see:
Color scheme of Setting and Status submenus (1553)
Position This column displays the position of the reagent container

(1 or 2) or of the solid waste container (only available on
e 801/e 602 modules).
R. Pack Lot ID This column displays the reagent lot number (only available
on e 801/e 602 modules).
Remaining This column displays the remaining amount of the reagent,

expressed in mL or number of items. When empty, a red 0 is
displayed in this column.
If the Preventive Action check box on the Overview menu is
selected, the remaining volume is displayed with the value
that has been set in Utility > System > Reagent Level.
Color scheme (Inventory list)
The following colors are used in the Test column to indicate

low levels of system reagents or consumables on the
modules:
The amount of reagent is below the purple alarm level.

24 Reagent menu
Roche Diagnostics
1576 Status submenu
The amount of reagent or consumables is below the

yellow alarm level.
e 801/e 602
o 1 of the 2 bottles on the module is empty for ProCell,
CleanCell, PreClean, or ProbeWash (e 602 only).
o 1 magazine is remaining on the magazine lifter.
o 1 of the 2 solid waste boxes is full.
This reagent or consumable is empty.
e 801/e 602
o Both of the bottles on the module are empty for
ProCell, CleanCell, PreClean, or ProbeWash (e 602
only).
o No magazines are remaining on the magazine lifter.
o Both solid waste boxes are full.
o The magazine waste is full.
The programmed yellow and purple alarm levels of each

reagent can be defined in Utility > System > Reagent Level.
u For information on reagent level check alarm settings,
see:
Buttons
Inventory Setting (e 602) Choose this button to display the Inventory Set window.
Use this window to enter the lot numbers of the ProCell M
bottles.
u See Inventory Set window (1578).
Reagent Prime (ISE, e 801/e 602 module) Use this button to prime the reagents of either the ISE
module (ISE Internal Standard, ISE Diluent, ISE Reference
Electrolyte), the e 801 modules (ProCell II M, CleanCell M,
PreClean II M), or the e 602 modules (ProCell M,
CleanCell M, PreClean M).
24 Reagent menu
u For more information on the e 801 and e 602 system

reagents, see:
About e 602 module system reagents (442).
Reagent Volume Reset After replacement of a reagent container, choose this

(ISE, c 701/c 702, c 502) button to reset the remaining volume of detergents
(photometric modules) or ISE reagents.
Roche Diagnostics
Status submenu 1577
A confirmation window appears. Choose Yes to reset the

remaining volume. Choose No to close the window without
any change.
u For information about resetting the reagent volume,
see:
module (324)
module (337)
module (340)
24 Reagent menu
Roche Diagnostics
1578 Inventory Set window
Inventory Set window

f Reagent > Status > Inventory Setting
On Status submenu, select e 602 from Module list box.
Use this window to specify the lot numbers for ProCell

loaded on an e 602 module.
ProCell Position1/2 This area contains 2 text boxes, ProCell Position 1, for the
ProCell lot number of position 1, and ProCell Position 2, for
the ProCell lot number of position 2.
24 Reagent menu
Roche Diagnostics
1579
Table of contents
Calibration menu 25
This chapter describes in detail the Calibration menu and

the windows accessed from it. From the Calibration menu
you can view the tests that require calibrations and
request the calibrations. In addition, you can view the
measured results and the reaction curves of current valid
calibrations. Information about calibrations is also entered
via this menu.
In this chapter 25
Status submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1581
Calibration Trace window . . . . . . . . . . . . . . . . . . . . . . . . 1586
Scale window - Calibration Trace. . . . . . . . . . . . . . . . . . 1591
Comment window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1592
Calibration Result (ISE) window . . . . . . . . . . . . . . . . . . . 1593
Calibration Result (Photometry) window. . . . . . . . . . . . 1595
Calibration Result (Immune) window . . . . . . . . . . . . . . . 1599
Working Information window. . . . . . . . . . . . . . . . . . . . . . 1604 25 Calibration menu
Scale window - Working Information . . . . . . . . . . . . . . . 1607
Reaction Monitor window . . . . . . . . . . . . . . . . . . . . . . . . 1608
Scale window - Reaction Monitor. . . . . . . . . . . . . . . . . . 1611
Instrument Factor window. . . . . . . . . . . . . . . . . . . . . . . . 1612
Start Up Setting window . . . . . . . . . . . . . . . . . . . . . . . . . 1614
Calibrators submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1616
Rack Assign window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1619
Install submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1621
Add window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1624
Detail window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1625
Roche Diagnostics
1580
Table of contents
Edit window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1626

Download window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1628
25 Calibration menu
Roche Diagnostics
Status submenu 1581
Status submenu
f Calibration > Status
Use the Status submenu to view detailed information about

the calibration status of the tests on the modules selected
in the Module list box. Use this submenu also to select tests
for start-up, timeout, changeover or manual calibrations.
u For information about the calibration workflow, see:
u For detailed information on special operations, see:
About lot and cassette calibration (467)
About calibration methods (468)
Module The Module list box contains all modules available on the
instrument. Select the module to be displayed in the status
25 Calibration menu
list or select All to display calibration information for all
modules. The content of the status list changes
accordingly.
Remaining Time This text box is used to set the timeout criteria (0-9999
hours). Any test that times out during this period is
recommended for a calibration and will be automatically
highlighted yellow in the Cause column if Preventive Action
is activated. The cause Calib. Now will be displayed in the
Cause column.
u See Preventive Action (1284).
Roche Diagnostics
1582 Status submenu
Color scheme
The following colors are used in the calibration status list:
Position
The latest calibration for a reagent failed.
Or: A reagent has no valid calibration.
Cause
The instrument has recommended this test for
calibration.
Cause
The test has been requested for calibration.
Status list
The status list in the center of the screen consists of 7

columns showing detailed information about the
calibration status of the tests on the modules selected in
the Module list box. It can be sorted by Position, Test,
Cause or Method by choosing the appropriate column
header. An arrow in the appropriate column header
distinguishes the selected column and sorting order.
Module This column displays the module for the corresponding

test. For immune modules, this column displays the module
and the measuring channel (1 or 2).
Position This column displays the reagent position on the

instrument. If the latest calibration for a test fails or no
calibration exists, the column turns red. Choose the
column header to sort the list by position.
Status This column displays each reagent’s status of precedence.

Currently used reagents are indicated by Current, standby
25 Calibration menu
reagents are indicated by SB1, SB2, … SBn.

The reagent which will be used after the Current is named
SB1, the reagent which will be used after SB1 is named SB2
and so on. The order of precedence of standby reagents
within the same lot is assessed by the reagents’ time of
registration; the oldest reagent is used first.
Test This column displays the test name. Choose the column
header to sort the list by test name.
Calib. Type This column displays whether a calibration is a lot

calibration (Lot) or a reagent cassette calibration (R. Pack).
There is no indication (blank space) for ISE tests.
Additionally for e 801, the calibration type can be a copy

calibration (Copy).
Roche Diagnostics
Status submenu 1583
For recommended and requested calibrations, the entry in

Calib. Type refers to the upcoming calibration. After a
calibration is successfully performed—Method and Cause
are blank—the entry in Calib. Type refers to the existing
calibration.
u Copy calibration (504)
Cause This column displays the reason for the calibration to be

carried out. Possible reasons include Changeover, Timeout,
Calib. Now, Failed, QC Violation and Manual. Choose the
column header to sort the list by cause.
When the calibration is highlighted yellow, the instrument

has recommended this test for calibration. When
highlighted blue, the test has been requested for
calibration.
Cause Occurrence
Changeover A new reagent cassette or a reagent
cassette of a new lot number is added
to the instrument.
Timeout The timeout period of the reagent is
exceeded.
Calib. Now The test times out during the period
specified in the Remaining Time box;
displayed only if Preventive Action is
activated.
Failed A calibration has failed and needs to
be repeated.
QC Violation When the test is configured for QC-
triggered calibration and a QC result is
outside of the defined range in the
data manager specified for this test.
Manual Calibration is manually requested by
the operator.
y Calibration causes
u For more information on calibration causes, see:

About recommended calibration (472) 25 Calibration menu
Method This column displays the calibration method selected in the
Method list box. Choose the column header to sort the list
by calibration method.
In the Method list box, different options for selecting the
calibration method are available. Options, depending on
modules and tests, are: None, Blank, 2 Point, Span and Full.
Method Occurrence
None Select this option for no calibration.
Blank Select this option for a calibration
recommendation for a blank
calibration.
y Calibration methods
Roche Diagnostics
1584 Status submenu
Method Occurrence
2 Point Select this option for a calibration
recommendation for a 2-point
calibration.
Span Select this option for a calibration
recommendation for a span
calibration.
Full Select this option for a calibration
recommendation for a full calibration.
Buttons
Start Up Use this button to select tests for calibration as defined on

the Start Up Setting window.
u See Start Up Setting window (1614).
Reject Use this button to reject a failed calibration after

confirmation.
• If auto masking is activated, no control or patient
sample can be measured with this reagent. Using the
Reject button, in this case, unmasks the test; results are
calculated with the previous valid calibration curve and
no Cal.E alarm is attached to the results.
• If auto masking is not activated, controls and patient
samples are measured but the results are calculated
with the previous calibration curve and a Cal.E alarm is
attached to the results. Using the Reject button, in this
case, deletes the calibration recommendation and no
Cal.E alarm is attached to the results.
Calibration Trace Choose this button to display the Calibration Trace

window. Use this window to view the plotted absorbance
values of the 50 most recent calibrations for a specific
test.
25 Calibration menu
q Absorbance values are produced by the

c 701/c 702/c 502 and counts (signal) by the e 801 and
e 602 modules.
u See Calibration Trace window (1586).
Roche Diagnostics
Status submenu 1585
Calibration Result Choose this button to display the Calibration Result

window. Use this window to view the results from the most
recent successful calibration for the test selected in the
status list. This window differs depending on the module,
ISE, c 701/c 702, c 502 or e 801/e 602 on which the test is
performed.
u See Calibration Result (ISE) window (1593).
u See Calibration Result (Photometry) window (1595).
u See Calibration Result (Immune) window (1599).
Use this window to view the reaction curve of the
calibration selected in the status list.
Instrument Factor Choose this button to display the Instrument Factor

window. Use this window to view the instrument factors for
the selected test. It is possible to edit the factors, if
necessary.
u See Instrument Factor window (1612).
Start Up Setting Choose this button to display the Start Up Setting window.
Use this window to select tests for a start up calibration.
u See Start Up Setting window (1614).
Save Choose this button to save the changes.
25 Calibration menu
Roche Diagnostics
1586 Calibration Trace window
Calibration Trace window

f Calibration > Status > Calibration Trace
w Calibration Trace window for ISE calibrations

25 Calibration menu
w Calibration Trace window for photometric calibrations
Roche Diagnostics
Calibration Trace window 1587
w Calibration Trace window for a calibration with a single calibrator on the e 801 module (empty Ref. column)
w Calibration Trace window for a calibration with a multi-calibrator on the e 801 module (multi-calibrators referenced in the Ref.
column to the calibrator levels)
25 Calibration menu
w Calibration Trace window for calibrations on the e 602 module
Roche Diagnostics
This window is used to review the absorbance values of the

50 most recent calibrations for a specific test on a specific
module and measuring channel.
The calibration data is plotted on the x-axis by date, with

the oldest calibration beginning at the left.
The left and right y-axes are scaled independently. They

can be scaled automatically or manually using the Scale
window.
Test/Module This list box displays the test and module combination
selected in the status list on the Status submenu. If you
select a different combination from this list box, the data in
this window will reflect the information for the combination
selected.
Scale This field displays the mode (Manual or Automatic) used to

set the scale for the calibration graph area. The scale
mode is defined on the Scale window accessible with the
Scale button.
u See Scale window - Calibration Trace (1591).
Period This field displays the date range represented by the

calibration points in the graph area.
Graph area
The graph area shows different information depending on

the selected test (photometric, ISE, immunology). The left
and right y-axes are scaled independently. They can be
scaled automatically or manually using the Scale window.
u See Scale window - Calibration Trace (1591).
Left axis For photometric and immunology tests, the concentration

values for the lowest concentrated calibrator is plotted on
the left axis ( ). For ISE tests, it refers to the calibrator 3
25 Calibration menu
(compensator).
Right axis For photometric and immunology tests, the concentration

values for the higher concentrated calibrators are plotted
on the right axis ( ). For ISE tests, the slope value is
plotted on the right axis.
Photometric tests The graph shows calibration results for the selected
photometric test. It displays the measured absorbance
values for both the Std (1) calibrator and the calibrator
with the maximum concentration Std (2)-Std (6) on one
plot.
Roche Diagnostics
Calibration Trace window 1589
The left and right y-axes are scaled independently:

• The left axis refers to the Std (1) calibrator represented
by .
In the case of a rate assay, it indicates the primary
wavelength absorbance at photometric measuring
point 1 of Std (1).
• The right axis refers to the maximum calibrator
Std (2)-(6) represented by .
In the case of a multi-point calibration, the absorbance
value of the highest calibrator is shown.
ISE tests The graph shows calibration results for the selected ISE
test. The left and right y-axes are scaled independently:
• The left axis refers to the measured concentration
values of the calibrator 3 (compensator) represented
by .
• The right axis refers to the calculated slope values
represented by .
Immunoassays The graph shows calibration results for the selected test; it
displays the measured signal values for both the low
concentration calibrator, Std (min), and the high
concentration calibrator, Std (max), on one plot.
The left and right y-axes are scaled independently:

• The left axis refers to the Std (min) calibrator
represented by .
Std (min) represents calibrator 1.
• The right axis refers to the Std (max) calibrator
represented by .
Std (max) represents calibrator 2, 4, or 5.
Calibration information
This area displays detailed information about the

25 Calibration menu
calibration point selected in the graph area.
Marker This field displays the marker for the calibrator in the graph
area.
Calibrator This column displays the calibrator type for the selected
calibration.
Level (e 801/e 602) This column displays the level used in the selected
calibration.
Ref. (e 801) This column references a multi-calibrator number to the

calibrator level that it was used for. If you use a single
calibrator for a given test, this column does not apply and a
- (minus) mark is displayed.
Roche Diagnostics
Code This column displays the calibrator code for this

calibration.
Calib. ID This column displays the calibration ID of the selected

calibration. The calibration ID is only available on ISE,
c 701/c 702, and e 801 modules.
Data This column displays the measured data for the selected
calibration, for example, the absorbance for photometric
modules.
For e 801/e 602, it displays the measured data for the
selected calibration in counts.
Alarm This column displays the alarm code for the selected
calibration if applicable. Please check the Calibration
Monitor report to find out which calibration alarm occurred.
For photometric modules, an asterisk (*) is displayed when

the data is adjusted or compensated.
For e 801/e 602, an asterisk (*) is displayed if an alarm
occurred while the calibrator was being measured.
Date This column displays the date and time when the selected
calibration was performed.
R1 R. P. Lot ID - R3 R. P. Lot ID This column displays the lot number of the reagent used to
perform the selected calibration.
R1 R. P. Seq. No. - R3 R. P. Seq. No. This column displays the sequence number of the reagent
used for the selected calibration.
Buttons
Previous
Choose this button to move the focus to the previous

result.
25 Calibration menu
Next
Choose this button to move the focus to the next result.
Scale Choose this button to display the Scale window. This

window is used to set the scale of the calibration trace.
u Scale window - Calibration Trace (1591).
Comment Choose this button to display the Comment window. This

window is used to enter a user-defined comment of up to
600 characters for the selected calibration.
Roche Diagnostics
Scale window - Calibration Trace 1591
Scale window - Calibration Trace

f Calibration > Status > Calibration Trace > Scale
This window is used to define the scaling of the graphics in

the Calibration Trace window.
Automatic Select this option to display the calibration trace with

automatic scaling. In this case, the system determines the
appropriate scaling necessary to display the calibration
values automatically.
Manual Select this option to define the scaling manually. Defining

the scaling manually can improve the resolution of the
graph.
Use the text boxes, to enter values for the lower and upper
limits of the scale.
You can define an individual scaling for each y-axis:

• The values of the left axis are represented by .
• The values of the right axis are represented by .
For the ISE module, the values represent concentration.

For photometric modules, the values represent
absorbance. For the e 801 and e 602 modules, the values
represent counts.
25 Calibration menu
Roche Diagnostics
1592 Comment window
Comment window
f Calibration > Status > Calibration Trace > Comment
This window is used to enter a user-defined comment of up

to 600 characters for the selected calibration. Comments
entered here will be included in the Calibration Trace
report.
25 Calibration menu
Roche Diagnostics
Calibration Result (ISE) window 1593
Calibration Result (ISE) window

f Calibration > Status > Calibration Result
This window is password protected. It can be viewed by an

operator with operator level password. A password level of
supervisor (or higher) is required to edit the data.
q It is not recommended to change the compensated

values.
Use this window to display the results of the most recent

successful calibration for the test selected in the status
list on the Calibration > Status submenu. The Calibration
Result window differs depending on the type of module on
which the test is performed.
Test This field displays the test name selected in the status list
on the Calibration > Status submenu.
25 Calibration menu
Module This field displays the module used to perform the

calibration.
u See also:
About calibration methods for ISE tests (470)
ISE Calib. Settings window (1740)
Calibration Result list
This list displays the results of the most recent successful

calibration for the test selected in the status list on the
Calibration > Status submenu.
Roche Diagnostics
1594 Calibration Result (ISE) window
Calib ID This field displays the calibration ID of the displayed

calibration.
IS EMF This field displays the electrical potential (electromotive

force) of the internal standard solution in millivolts (mV) for
Na+, K+ and Cl-.
Std (1) Low EMF This field displays the electrical potential (electromotive
force) of ISE calibrator Std (1) (LOW standard) for Na+, K+
and Cl-.
Std (2) High EMF This field displays the electrical potential (electromotive
force) of ISE calibrator Std (2) (HIGH standard) for Na+, K+
and Cl-.
Std (3) Compensator EMF This field displays the electrical potential (electromotive
force) of ISE calibrator Std (3) for Na+, K+ and Cl-.
Slope This field displays the calculated slope of each electrode

cartridge for Na+, K+ and Cl-.
IS Conc. This field displays the calculated concentration of the

internal standard solution as determined during calibration
for Na+, K+ and Cl-.
Std (3) Comp Conc. This field displays the measured concentration of the ISE
calibrator Std (3) as determined during calibration for Na+,
K+ and Cl-.
Compensated Value These three text boxes display the difference between the
target value of the ISE calibrator Std (3) and its measured
value for Na+, K+ and Cl-. The compensated value can range
from -99999 to 999999. The difference is added to all
measured controls and patients to compensate for the
fact that the ISE calibrators Std (1) and Std (2) are aqueous
based and the measured samples are not.
25 Calibration menu
q It is recommended not to change the calculated

difference (the compensated values). However, for
research or special investigative studies, the compensated
values can be changed provided that the ISE units are fully
recalibrated before measuring and reporting control and
patient results.
Roche Diagnostics
Calibration Result (Photometry) window 1595
Calibration Result (Photometry) window

This window is password protected. It can be viewed by an

operator with operator level password. A password level of
supervisor (or higher) is required to edit the data.
For tests performed on photometric modules, the

Calibration Result window displays a summary of
calibration information for all photometric tests available
on the instrument.
u See also:
Calibrating tests on the ISE and cobas c modules (498)
Automatic Calibration Monitor report (1454)
Calibration information 25 Calibration menu

This list displays calibration information for the test
selected in the Calibration Result list.
Calibration Type This field displays the calibration curve type for the
selected test. The calibration method is programmed on
the Utility > Application > Calib. screen. The options are:
Linear, Spline, Line Graph, RCM, RCM2T1, RCM2T2.
u Overview of calibration curve types (1958)
Calib ID This field displays the calibration ID of the displayed

calibration.
R1 R. P. Lot ID - R3 R. P. Lot ID This field displays the lot number of the reagent used for
the currently selected calibration.
Roche Diagnostics
1596 Calibration Result (Photometry) window
R1 R. P. Seq. No. - R3 R. P. Seq. No. This field displays the serial number of the reagent used for
This list displays a summary of calibration information for

all photometric tests available on the instrument.
Test This column displays the short name of all the photometric
tests available on the instrument.
Module This column displays the module to which the test is

assigned.
Position This field displays the position where the reagent cassette
is located.
S1 Abs. This column displays the mean absorbance (× 10⁴) of

standard (1). The number can be changed by using the text
box below the list. Use the text box to define the values of
the S1 absorbance. Edit the value in the text box and press
Enter to change the value.
If standard (1) to standard (6) is used, this column displays

one absorbance value below the other.
K This column displays the reciprocal of the calibration slope

(K-factor). The number can be changed by using the text
box below the list. Use the text box to define the
coefficient. Edit the value in the text box and press Enter to
change the value.
If standard (1) to standard (6) is used, this column displays

one K-factor below the other.
A This column displays the nonlinear coefficient A (slope).

The number can be changed by using the text box below
the list.
25 Calibration menu
B This column displays the nonlinear coefficient B (intercept).

The number can be changed by using the text box below
the list.
L This column displays the bichromatic absorbance

difference of the lipemic index. The number can be
changed by using the text box below the list.
H This column displays the bichromatic absorbance

difference of the hemolysis index. The number can be
I This column displays the bichromatic absorbance

difference of the icterus index. The number can be
Roche Diagnostics
Calibration Result (Photometry) window 1597
Lot Calibration Result text boxes
In the Calibration Result list some values can be edited. The

Lot Calibration Result text boxes display the original values
for a lot calibration.
S1 Abs This box displays the mean absorbance (× 10⁴) of standard

(1).
S2 Abs - S6 Abs These boxes display the absorbance (× 10⁴) of standard (2)
to standard (6).
K This box displays the reciprocal of the calibration slope

(K-factor).
K2–K5 These boxes display the K-factor for the corresponding

standard.
A This box displays the nonlinear coefficient A (slope).
B This box displays the nonlinear coefficient B (intercept).
L This box displays the bichromatic absorbance difference of

the lipemic index.
H This box displays the bichromatic absorbance difference of

the hemolysis index.
I This box displays the bichromatic absorbance difference of

the icterus index.
Newest Calibration Result text boxes
In the Calibration Result list some values can be edited. The

Newest Calibration Result text boxes display the original
values for the newest calibration.
S1 Abs This box displays the mean absorbance (× 10⁴) of standard

25 Calibration menu
(1).
S2 Abs - S6 Abs These boxes display the absorbance (× 10⁴) of standard (2)
to standard (6).
K This box displays the reciprocal of the calibration slope

(K-factor).
K2–K5 These boxes display the K-factor for the corresponding

standard.
A This box displays the nonlinear coefficient A (slope).
B This box displays the nonlinear coefficient B (intercept).
Roche Diagnostics
1598 Calibration Result (Photometry) window
L This box displays the bichromatic absorbance difference of

the lipemic index.
H This box displays the bichromatic absorbance difference of

the hemolysis index.
I This box displays the bichromatic absorbance difference of

the icterus index.
Button
Working Information Choose this button to display the Working Information

window. This window is used to display the calibration
curve for the test selected in the Calibration Result list.
u For more information see Working Information
window (1604).
25 Calibration menu
Roche Diagnostics
Calibration Result (Immune) window 1599
Calibration Result (Immune) window

w Calibration Result window for the e 801 module
25 Calibration menu
w Calibration Result window for the e 602 module
This window differs depending on the type of calibration

performed (qualitative or quantitative).
Roche Diagnostics
1600 Calibration Result (Immune) window
For the calibration of qualitative tests, two calibrators are

used. For the calibration of quantitative tests, two, four, or
five calibrators are used.
Use this window to view the results from the most recent
successful calibration for the test selected in the status
list on the Calibration > Status submenu. The Calibration
Result window differs depending on the type of module and
measuring cell on which the test is performed. The type of
module and measuring cell is displayed at the top of the
window.
Calibration Information

selected in the Calibration > Status submenu.
Calib. ID For e 801 modules, this field displays the calibration ID of

the selected calibration. For e 602 modules, no data is
displayed in this field.
Test This field displays the test selected from the Calibration
> Status submenu.
Module This field displays the name of the module and the
measuring channel on which the selected test was
performed, e.g., e2-1 for the second e 801 or e 602
module, measuring channel 1.
Calibration Type This field displays the calibration curve-type for the
selected test. The calibration method is either Rodbard,
Linear or Linear Reciprol (reciprocal) for quantitative
assays, or Cutoff, for qualitative assays.
Unit This field displays the unit of measurement for each test as
defined on Utility > Application.
Date This field displays the date when the currently selected
25 Calibration menu
Time This field displays the time when the currently selected
Calibrator Lot ID This field displays the lot number of the calibrator used for
R. Pack Lot ID This field displays the lot number of the reagent cassette
used for the currently selected calibration.
R. Pack Seq. No. This field displays the sequence number of the reagent
cassette used for the currently selected calibration.
Roche Diagnostics
Status Messages Messages describing the status of the calibration may

appear. One of the following messages will be displayed
directly above the calibration result table:
• L-Calib. = Lot calibration
• R-Calib. = Reagent cassette calibration
Status message Explanation

“L-Calib. was generated!” The reagent cassette was
calibrated within 24 hours on
board.
“L-Calib. could not be The reagent cassette was
generated! Released as R- calibrated after 24 hours on
Calib.” board.
“L-Calib. could not be With expired reagent only
generated! Calib. with expired reagent cassette calibration
Rack Pack.” can be generated.
“L-Calib. could not be The calibration failed. Check
generated!” the calibration quality criteria
to determine the reason for
the calibration failure.
y Explanation of the status messages
This list displays calibration details, including the

calibration quality criteria for the last calibration
performed. The following fields may or may not be present
in the table depending on the type of assay (qualitative or
quantitative).
q On the Calibration Result window, only the calibration

criteria listed below are displayed. In addition, the
following calibration flags can be attached to the results:
NG, >Sig, <Sig, and Sig.E.
tests (1981)
25 Calibration menu
Level These columns display the values for the different
calibrator levels.
Target This line displays the target value for the corresponding
calibrator level.
Signal 1 … Signal 4 These lines display the signals measured for each of the
measuring channels for the corresponding calibrator level.
The measured signal of the calibrator should fall between
the designated minimum and maximum signal. Minimum and
maximum signals are test dependent.
Roche Diagnostics
1602 Calibration Result (Immune) window
The following calibration alarms may be displayed instead

of a signal value:
• Sig.E: The calibrator signal is outside the designated
minimum/maximum signal range.
• NG: No calibrator signal was detected by the measuring
cell.
u For more information, see
Alarms for calibrations (1206)
tests (1981)
Flags for Monotony, Diff., Dupl., and Sys. Err. These lines display short names of the calibration quality
criteria for the last calibration performed. The following
flags are displayed for each criterion:
• If the criterion is met, -- is displayed.
• If the criterion is not met, NG is displayed in the
Calibration Result window and the corresponding
calibration flag is attached to the result.
Monotony Criterion: All measured calibrator values fall in ascending

(quantitative tests on e 602 only) or descending order (monotony of curve). Corresponds to
the calibration flag Mono.E.
Slope Criterion: All measured calibrator values fall in ascending

(qualitative tests on e 602 only) or descending order (monotony of curve). Corresponds to
the calibration flag Slop.E.
Diff. Criterion: The difference between the level 1 and level 2

calibrator values must be above the permissible value.
Otherwise, the curve is too flat (Diff.E flag).
Dupl. Criterion: The deviation of duplicate measurements for the

corresponding calibrator level lies within the range defined
on Utility > Application > Calib.. Otherwise, the calibration is
failed (Dup.E flag).
The range is downloaded with the application. For most of

the assays, the range is set to 10%. For a few assays, the
25 Calibration menu
range must be manually edited according to the

Sys. Err. Criterion: No error occurred during the calibration.

• If the calibration failed, NG is displayed and the Sys.E
data alarm is attached to the result.
Below the Calibration Result list
The fields displayed below the list differ between

qualitative and quantitative tests.
Roche Diagnostics
Calculation Result (4, 5 point) (quantitative This field applies to Rodbard 4- or 5-point calibrations. If an
tests on e 801 modules) error occurred in the calculation process, NG is displayed.
If the calculation was successful, -- is displayed.
Factor (e 801 modules and for quantitative The factor of a lot calibration (L-Calib.) is 1.00. The factor
tests on e 602 modules) of a reagent cassette calibration (R-Calib.) must lie
between 0.8 and 1.2. Otherwise, the calibration is failed
and the corresponding message is displayed in the header
of the report (Factor flag). If the calibration factor is not
calculated, 0.000000 for e 801 modules or 0.000 for
e 602 modules is displayed in this field.
The calibration factor criterion is only used for validating

cassette calibrations.
Diff. (qualitative tests) This field displays the result of the minimum difference
check between calibrator 1 and 2. If the minimum
difference check fails, NG is displayed. If the check was
successful, -- is displayed.
Cutoff. (qualitative tests) This field displays the calculated cutoff value for this
sample. The cutoff value allows to classify the result as
being reactive or non-reactive.
Border Area (qualitative tests) This field displays the gray zone related to the cutoff value.
In the gray zone (around cutoff value = 1) you cannot
classify the result as being reactive or non-reactive.
u Related topics
• Calibration of immunology tests (1979)
• Factors for calculation of calibration quality criteria for
qualitative tests (1982)
• Alarms for calibrations (1206)
25 Calibration menu
Roche Diagnostics
1604 Working Information window
Working Information window

f Calibration > Status > Calibration Result > Working
Information
On the Status submenu, select a photometric test.
Use this window to display the calibration curve for any

photometric assay.
The absorbance is plotted on the Y axis. The concentration

or log of the concentration, based on the calibration type,
is plotted on the X axis.
Information list

selected in the Calibration Result window.
25 Calibration menu
Result window. The calibration curve for this test is shown

in the graph.
Module This field displays the name of the analytical module and
the position where the test is assigned.
Calibration Type This field displays the calibration method for the selected
test. The calibration method is programmed on the Utility
> Application > Calib.. The options are: Linear, Spline, Line
Graph, RCM, RCM2T1, RCM2T2.
u Overview of calibration curve types (1958)
R1 R. P. Lot ID - R3 R. P. Lot ID This field displays the lot number of the reagent cassette
used for the currently selected calibration.
Roche Diagnostics
Working Information window 1605
R1 R. P. Seq. No. - R3 R. P. Seq. No. This field displays the ID bottle number of the reagent used
for the currently selected calibration.
Result list
This list displays the calibration result for the test selected
in the Calibration Result window.
S1 Abs. This field displays the absorbance (x 10⁴) of standard (1).
S2 Abs. - S6 Abs. These fields display the absorbance (x 10⁴) of standards (2)
- (6), if necessary.
K1–K5 These fields display the reciprocal of the calibration slope

(K-factor). For tests using other calibration methods, this
number is automatically updated following each successful
calibration or Calib flagged calibration.
A This field displays the nonlinear coefficient A (slope).
B This field displays the nonlinear coefficient B (intercept).
L This field displays the bichromatic absorbance difference

of the lipemic index.
H This field displays the bichromatic absorbance difference

of the hemolysis index.
I This field displays the bichromatic absorbance difference

of the icterus index.
Scale This field displays whether the absorbance range plotted

on the Y axis is set automatically by the system or manually
by the user.
Absorbance list 25 Calibration menu

This list displays the absorbance for the measuring point
selected.
Point This field displays the measuring point for the absorbance
value.
Abs. 1 This field displays the first replicate absorbance result for
the selected calibrator.
Abs. 2 This field displays the second replicate absorbance result

for the selected calibrator.
Update Factor 1/Update Factor 2 This field displays the update factor for the selected
calibrator.
Roche Diagnostics
1606 Working Information window
Buttons
Previous
Choose this button to move the focus to the previous

result.
Next
Choose this button to move the focus to the next result.
Scale Choose this button to display the Scale window. Use the
Scale window to choose automatic scale settings or to set
the scale setting for the calibration manually.
u See Scale window - Working Information (1607).
25 Calibration menu
Roche Diagnostics
Scale window - Working Information 1607
Scale window - Working Information

f Calibration > Status > Calibration Result > Working
Information > Scale
Use the Scale window to choose automatic scale settings

or to set the scale settings manually. Use the Scale window
to change the format of the working information graph. By
adjusting the scale to be viewed, you can focus on specific
points in the calibration curve.
Automatic Choose this option for automatic scale setting. This option
allows the instrument to determine the appropriate scale
setting necessary to display the values in the graph.
Manual Choose this option to define scale settings manually. If the

Manual option is selected, two text boxes are enabled.
Type the lower scale limit (-40 000 to 40 000) in the first
text box and press the Tab key. Type the upper scale limit
(-40 000 to 40 000) in the second text box and press the
Tab key.
25 Calibration menu
Roche Diagnostics
Reaction Monitor window

f Calibration > Status > Reaction Monitor

test on the most recent calibration. The absorbance values
for the reaction (Abs × 10⁴) are plotted on the Y axis and
the measuring points for the time of reaction are plotted
on the X axis.
Data list
This list displays data of the test selected in the Calibration

> Status submenu.
> Status submenu.
25 Calibration menu
Module This field displays the name of the analytical module and
the position where the test is assigned.
Conc. This field displays the absorbance of the final reaction

product.
Prozone This field displays a prozone value if applicable to the

assay type.
Limit This column displays the test-specific S1 absorbance limit.
Cell No. This field displays the number of the reaction cell where
the reaction occurred.
Reagent This field displays the reagent R1–R3.
Roche Diagnostics
R. Pack Lot ID This field displays the lot number of the cobas c pack.
R. Pack Seq. No. This field displays the sequence number of the
cobas c pack.
Std Choose this list box to select the standards (1st or 2nd
replicates) to graph. Select the desired standard from the
list and press Enter.
Scale This field displays the type of scale setting used.
Absorbance list
This list displays the absorbance for the measuring point

selected.
Point This field displays the measuring point for the absorbance
value. 1 to 38 (c 701/c 702) or 1 to 70 (c 502) measuring
points can be displayed in accordance with the individual
reaction times.
Abs. This field displays the absorbance value for the displayed
measuring point.
Graph area
This area displays the graph of the selected test. Use the
scroll bar to move to and display the information for the
selected point on the graph.
Buttons
Previous
Choose this button to move the focus to the previous 25 Calibration menu
point.
Next
Choose this button to move the focus to the next point.
Send to DM Choose this button to send the results to the data

manager.
Previous Choose this button to display the reaction graph displayed

immediately prior to the current one.
Roche Diagnostics
Scale Choose this button to display the Scale window. Use this
window to adjust the scale of the reaction monitor graph.
u See Scale window - Reaction Monitor (1611).
25 Calibration menu
Roche Diagnostics
Scale window - Reaction Monitor 1611
Scale window - Reaction Monitor

f Calibration > Status > Reaction Monitor > Scale
Use the Scale window to choose automatic scale settings

or to set the scale settings manually.
Automatic Choose this option for automatic scale settings. This

option allows the instrument to determine the appropriate
scale setting necessary to display the reaction monitor.
Manual Choose this option to define scale settings manually. If the

Manual option is selected, two text boxes are enabled.
Type the lower scale limit (-10 000 to 40 000) in the first
text box and press the Tab key. Type the upper scale limit
(-10 000 to 40 000) in the second text box and press the
Tab key.
25 Calibration menu
Roche Diagnostics
1612 Instrument Factor window
Instrument Factor window

f Calibration > Status > Instrument Factor
This window can be viewed by an operator with operator

level password, but a password level of supervisor (or
higher) is required to edit the data.
This window shows the instrument factors for all tests

defined on the instrument.
q The use of the Instrument Factor window for

immunoassays is not supported by Roche. The use is
entirely within the responsibility of the customer.
u About linear calibration (1959)
Factors list
This list shows all test and module combinations with their
corresponding instrument factors defined on the
instrument. The factors correspond to the slope (factor a)
and the intercept (factor b) of the graph defined by the
linear equation, Y = aX + b.
Test This column displays the name of the test.
Module This column displays the module and the reagent disk
(c 701/c 702: A or B). For e 801/e 602 modules, this
column displays the module and the measuring channel
25 Calibration menu
(1 or 2).
Factor (a) This column displays the factor (a) representing the slope
(-99999 to 999999).
Factor (b) This column displays the factor (b) representing the
intercept (-99999 to 999999).
Roche Diagnostics
Instrument Factor window 1613
Y = aX + b area
This area contains 2 text boxes that display the values for
the test/module combination currently selected in the
factors list. To edit the values for a specific test/module
combination, select the appropriate entry in the factors list
and enter the new values for a and b in the corresponding
text boxes.
a This text box is used to enter the value for factor a (slope,
-99999 to 999999).
b This text box is used to enter the value for factor b

(intercept, -99999 to 999999).
For immunology tests, you must enter the intercept in the
default unit of the analyte.
For photometric tests, you must enter the intercept in the
measuring unit currently used for the analyte.
Button
Update Choose this button to update the display of the factors in

the list.
25 Calibration menu
Roche Diagnostics
1614 Start Up Setting window
Start Up Setting window

f Calibration > Status > Start Up Setting
Use this window to select tests and their methods for a

start-up calibration.
u For more information on start-up calibration, see:
Creating a start-up group (480)
A start-up calibration may be performed for the selected

tests at the beginning of a work shift. A start-up calibration
overrides selections appearing on the Calibration > Status
submenu.
q A start-up calibration may also be performed during a

routine run by selecting the Start Up button on the
Calibration > Status submenu and loading the required
calibrator rack(s).
Start Up list
This list displays all the tests available on the instrument

and their start up calibration method. It can be sorted by
Module or Test by choosing the appropriate column
Module This column displays the module and reagent

disk/measuring channel for the corresponding test name.
Choose the column header to sort the list by module.
Test This column displays the test name. Choose the column
header to sort the list by test name.
25 Calibration menu
Method This column displays the calibration method selected.
In the Method list box different options for selecting the

calibration method are available. Options, depending on
modules and tests, are: None, Blank, 2 Point, Span and Full.
q For e 801/e 602, only Full is available as a calibration

method.
Roche Diagnostics
Start Up Setting window 1615
Method Occurrence
None Select this option for no calibration.
Blank Select this option for a calibration
recommendation for a blank
calibration.
2 Point Select this option for a calibration
recommendation for a 2-point
calibration.
Span Select this option for a calibration
recommendation for a span
calibration.
Full Select this option for a calibration
recommendation for a full calibration.
25 Calibration menu
Roche Diagnostics
1616 Calibrators submenu
Calibrators submenu
f Calibration > Calibrators
This submenu can be viewed by an operator with operator

higher) is required to assign the rack and position.
w Calibrators submenu with clinchem and e 602 calibrators (single calibrators only ending L1 and L2)
25 Calibration menu
w Calibrators submenu with e 801 single calibrators (ending L1 and L2) and multi-calibrators (ending R1 and R2)
Roche Diagnostics
Calibrators submenu 1617
Use the Calibrators submenu to view information about

already registered calibrators and the current rack
assignment.
If you are using calibrators without a barcode, you must

assign each calibrator to a rack number and position.
u For information about particular tasks associated with
this submenu, see:
Assigning non-barcoded calibrators to rack
positions (494)
Calibrator list
This list displays the position assigned to the calibrator,

the calibrator name, rack and position number, code
number, lot number and expiry date. It can be sorted by
Calibrator or Rack No. - Pos. by choosing the appropriate
column header. An arrow in the appropriate column header
Calibrator This column displays the calibrator name. For e 602

modules and for single calibrators on e 801 modules, the
column displays the calibrator level additionally. For
example, -L2 stands for the calibrator 2 or Std (2).
For multi-calibrators on e 801 modules, reference numbers
indicate for which calibrator level the calibrator is used for
the respective test. For example, -R2 is the reference
number for calibrator 2.
Rack No. - Pos. This column displays the rack number and position of the
calibrator (e.g., C12345-3 for rack no. C12345, position
3). Choose the column header to sort the list by rack
number.
Code This column displays the calibrator code number. The Code
column is empty for e 602 tests: calibrator codes are not 25 Calibration menu
used for e 602 calibrators.
Exp. Date This column displays the expiry date of the calibrator lot.
q The Exp. Date column is highlighted in red, if the

corresponding calibrator has expired.
Roche Diagnostics
1618 Calibrators submenu
Button
Rack Assign Choose this button to display the Rack Assign window. Use
this window to assign a position to a calibrator.
u See Rack Assign window (1619).
25 Calibration menu
Roche Diagnostics
Rack Assign window 1619
Rack Assign window

f Calibration > Calibrators > Rack Assign
This window is used to assign a calibrator to a position.
q Do not use barcoded calibrators on racks that have

been assigned for non-barcoded calibrators. In this case
no calibration is performed. The rack is passed through to
the rack unloading area.
Calibrator list
This list, on the left side of the window, displays all

calibrators installed on the instrument.
Calibrator This column displays the name of the calibrator and its 25 Calibration menu
level. For example, -L2 stands for the calibrator 2 or
Std (2).
Code This column displays the calibrator code number. The Code
column is empty for e 602 tests: calibrator codes are not
used for e 602 calibrators.
Rack No. and position list
This list, on the right side of the window, displays all

possible rack numbers and positions.
Rack No. - Pos. This column displays the rack number and position.
Roche Diagnostics
1620 Rack Assign window
Calibrator This column displays the name of the calibrator and its
level assigned to the corresponding position, if one is
assigned.
Code This column displays the code of the calibrator assigned to

this position, if one is assigned.
Lot ID This column displays the lot number of the calibrator

assigned to this position, if one is assigned.
Buttons
Add > Choose this button to add the calibrator currently selected
in the calibrator list to the position currently selected in the
position list.
< Remove Choose this button to remove the calibrator assigned to

the position selected in the position list from that position.
25 Calibration menu
Roche Diagnostics
Install submenu 1621
Install submenu
f Calibration > Install
This submenu can be viewed by an operator with operator

higher) is required to edit the data.
The Install submenu is divided into two options, Chemistry

and Immune. Choose the corresponding option from the list
box to access the respective submenu.
Use the Chemistry option to download, add and delete

calibrators for tests performed on a photometric or ISE
module, and to assign calibrator values. You can also see
the details for the selected calibrator.
Use the Immune option to delete calibrators or to

download calibrator information for tests performed on
25 Calibration menu
the e 801/e 602 module. You can also see the details for
the selected calibrator.
u For information about particular tasks associated with
this submenu, see:
Installing calibrator data manually (490)
Calibrator list
The list on the left displays information for all chemistry or

immune calibrators entered in the instrument.
Roche Diagnostics
1622 Install submenu
No. This column displays the number of calibrators on the

instrument. Up to 160 chemistry calibrators and
100 immune calibrators can be installed on the instrument.
Calibrator This column displays the name of each calibrator.
Code This column displays the calibrator code for each

(Chemistry and e 801) calibrator installed on the instrument.
Lot ID This column displays the lot number of each calibrator.
Test list
The list on the right displays details about the tests

assigned to the calibrator highlighted in gray in the
calibrator list.
Test This column displays the test name.
Module This column displays the module for the corresponding

test.
Std (1) … Std (6) For chemistry calibrators, the set point for each standard
is displayed in the appropriate column.
For immune calibrators, the level for each calibrator is

displayed in the appropriate column.
q Qualitative and quantitative immunology tests

performed on the e 602 module use 2 single calibrators for
calibration (Std (1) and Std (2)).
The e 801 module uses single and multi-calibrators for 2-,
4- and 5-level calibrations (Std (1) through Std (5)). In the
Std (1) through Std (5) columns multi-calibrators are
referenced to the level that these calibrators are used for.
25 Calibration menu
Buttons
Add Select an empty position and choose this button to display

(Chemistry only) the Add window. Use the Add window to add a calibrator to
the instrument (supervisor level).
u See Add window (1624).
Delete Use this button to delete the selected calibrator(s) after

confirmation.
Detail Use this button to display details about a calibrator

selected from the left list.
u See Detail window (1625)
Roche Diagnostics
Edit Select the calibrator to be edited and choose this button

(Chemistry only) to display the Edit window. Use the Edit window to assign
calibrator set point values for calibrators (supervisor level).
u See Edit window (1626).
Download Use this window to download calibrator data from the data
manager (supervisor level).
u See Download window (1628).
25 Calibration menu
Roche Diagnostics
1624 Add window
Add window
f Calibration > Install > Chemistry > Add
Use the Add window to add a calibrator to the instrument

or to change calibrator data from an existing calibrator. If
you try to add a calibrator that is already defined in the
instrument, you receive a message. Two lots of the same
calibrator cannot be installed at one time.
u Installing calibrator data manually (490)
Calibrator Use this text box to define a name for the calibrator. Type
in the name (up to 8 characters) and press the Tab key.
Code Use this text box to enter the code number associated with
the calibrator. Type in the code (1 to 32 000) and press
Tab.
Lot ID Use this text box to define a lot number for the calibrator.
Type in the lot number (up to 8 characters) and press Tab.
Exp. Date Use these 2 text boxes to define the expiry date of the
calibrator. One text box is used for the year (0 to 99), the
other is used for the month (1 to 12). The use of each text
box depends on the date settings. In the guidance prompt
you can see which text box is used for the year and which
one for the month.
25 Calibration menu
Roche Diagnostics
Detail window 1625
Detail window
f Calibration > Install > Detail
Use this window to display details about a calibrator

selected on the Calibrator > Install submenu. The window
shows details for all module types on which the calibrator
with the same Code and Lot ID is registered.
Calibrator This field displays the name of the selected calibrator.
Code (chemistry and immunology) This field displays the calibrator code of the calibrator.
Lot ID This field displays the lot number of the calibrator.
Module Type This field displays on which module types the calibrator
with the same Code and Lot ID is registered.
Exp. Date This field displays the expiry date of the calibrator lot (shelf
life). 25 Calibration menu
Version This field displays the version number of the registered
calibrator.
Release Date This field displays the date when this version of the
calibrator was released.
Roche Diagnostics
1626 Edit window
Edit window
f Calibration > Install > Chemistry > Edit
Use the Edit window to assign calibrator set point values

for calibrators. Highlight each test and enter the
concentration. You may enter a value for the first time or
edit an existing value.
u Editing calibrator concentration values on cobas c
modules (491).
q When changing the concentration value of a

calibrator, the calibration curve might be updated even
before the calibration measurement is performed.
o In order to avoid incorrect results, the number of
decimal places shall be changed in Utility > Application
> Range if required.
o Always re-calibrate the test to obtain a lot calibration in
25 Calibration menu
order to ensure no incorrect results have been

reported for the current reagent lot or for all previously
registered reagents lots that will be used. In addition,
reagent cassettes currently in use must be re-
calibrated.
o Make sure to perform the calibration measurements
prior to any other determinations.
Calibrator This field displays the name of the calibrator.
Code This field displays the calibrator code.
Lot ID This field displays the lot number of the calibrator.
Roche Diagnostics
Edit window 1627
Test list
The list displays details about the tests assigned to the

calibrator and the set points assigned.
Test This column displays the test name.
Module This column displays the module to which the test is

assigned.
Std (1) … Std (6) The set point for each standard is displayed in the
appropriate column. For ISE, Std(1) = Low, Std(2) = High,
and Std(3) = Comp. The standard concentration must be
entered manually via the Std Concentration area.
Std Concentration
For the ISE tests the area contains 3 text boxes labeled
Low, High and Comp.
For photometric tests, the area contains 6 text boxes
labeled Std (1) through Std (6). Use these text boxes to
enter the standard concentration (0 to 999999) of the
selected test.
Unit This field displays the unit of measure used for the test
selected in the Test list.
Button
Update Choose this button to update the changes into the list.
q Note for spline calibrations:

When a new concentration value of a new calibrator is
entered into the instrument, the calibration curve is
immediately updated, that is, even before the actual
calibration measurement is performed.
25 Calibration menu
Make sure to perform the calibration measurement prior to
any other determinations.
Roche Diagnostics
1628 Download window
Download window
f Calibration > Install > Download
This window can be accessed by an operator with

supervisor (or higher) level password only.
Use this window to download new calibrator data or update

existing calibrator data from the data manager.
u Installing calibrator data from the data manager (488)
Supervisors may download parameters for the newest and

the current release of an installed calibrator. Supervisors
can neither download parameters for an older release nor
parameters for a different calibrator. Administrators may
download any available calibrator parameters.
Supervisor Administrator
Update calibrator lot to newest release l l
25 Calibration menu
Download current release of calibrator lot again l l

Download different calibrator lot for an already l l
installed calibrator (same code)
Download any calibrator and release – l
y User rights for downloading calibrator parameters

Search Using area
This area displays the search criteria.
Roche Diagnostics
All Item Search for all calibrator parameters. Only the calibrators
for the installed tests are displayed.
Required Item This search option lists all calibrators that are on board but
for which the calibrator information was not yet
downloaded. This function works identical to the Parameter
Download window.
Calibrator This search option displays the Calibrator list box. Select
the desired calibrator from the list box.
Lot ID This search option displays the Lot ID text box. Enter the
lot number of the calibrator you are searching for.
Result area
This area displays the results that match the search

criteria.
Selection This column indicates whether the corresponding

calibrator is selected for downloading. If selected, a check
mark appears in this column.
Calibrator This column displays the name of the calibrator. Choose

the column header to sort the list by calibrator name.
Buttons
Search Use this button to search for calibrator parameters with

the selected search options.
Download Use this button to download the calibrator parameters

from the data manager.
25 Calibration menu
Roche Diagnostics
1630 Confirmation window
Confirmation window
f Calibration > Install > Download > Download
Use this window to verify the selection before the

calibrator parameters are downloaded. With an
administrator level password, you can select the desired
release of the calibrator parameters.
u Installing calibrator data from the data manager (488)
Calibrator This line displays the name of the calibrator.
Code This line displays the calibrator code.
Lot ID This line displays the lot number of the calibrator.
Module Type This line displays the module types for which the calibrator
with the same Code and Lot ID can be downloaded.
Exp. Date This line displays the expiry date of the calibrator lot.
25 Calibration menu
Version This line displays the version number of the calibrator

parameters.
Current Release Date This line displays the release date of the calibrator lot
currently on board. This is only available if the same
calibrator lot is requested for download.
Roche Diagnostics
Addition Release Date/ This list box displays the release that will be newly
Update Release Date installed. Administrators may select other available
releases. The newest one is always on top. Select None
from the list box if you want to skip downloading the
parameters for a specific module.
The Addition Release Date list box is only displayed if a new
calibrator lot is added.
The Update Release Date list box is only displayed if an
existing calibrator lot is updated.
25 Calibration menu
Roche Diagnostics
1632
25 Calibration menu Confirmation window
Roche Diagnostics
1633
Table of contents
QC menu 26
This chapter describes in detail the Quality Control menu

and the windows accessed from it. From the QC menu you
can view which controls need to be measured and request
them for measurement. Controls can be installed or
deleted via this menu. Information about quality controls
and to which test they apply is also entered via this menu.
In this chapter 26
Status submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1635
Stand By Bottle QC window . . . . . . . . . . . . . . . . . . . . . . 1638
Unloading window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1640
Run Status submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1641
Controls submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1644
Rack Assign window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1646
Install submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1648
Add window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1650
Detail window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1651
Download window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1652
26 QC menu
Roche Diagnostics
1634
Table of contents
26 QC menu
Roche Diagnostics
Status submenu 1635
Status submenu
f QC > Status
Use the Status submenu to view detailed information about

the QC status of the tests on the modules selected in the
Module list box. Use this submenu also to select tests for
manual QC or to unload QC racks from the auto QC
compartment.
The list can be sorted by each of its columns. Select or

deselect a test for QC in the Select column of the
corresponding test. Selected tests have a check mark in
the Select column. Choose Save to request QC
measurements for the selected tests.
u For more information on special operations, see:
About QC types (515)
Performing routine QC (519)
Performing QC for standby reagents (521)
Module Select a module from this list box to view information about
the controls on this module.
Color scheme The following colors are used in the QC Status list:
26 QC menu
Color Column Meaning

* The onboard stability is exceeded for controls in the auto QC
compartment.
Cause The instrument has recommended this test for QC
measurement.
y Color scheme for Status list
Roche Diagnostics
1636 Status submenu
Status list
This list displays information about controls currently

active on the system. The list can be sorted by each of its
columns by choosing the appropriate column header. An
arrow in the appropriate column header distinguishes the
selected column and sorting order.
Select This column displays a check mark when the corresponding

test has been selected for QC. Select or deselect a test for
QC in the Select column of the corresponding test.
* This column displays an asterisk (*) to denote which control

is used as automatic QC. Expired controls (the onboard
stability is exceeded) show a yellow background and the
system issues a yellow alarm. Choose the column header
to sort the list by automatic QC.
u About QC types (515)
Performing timeout QC (523)
Performing QC after calibration (525)
Module This column displays the module name and reagent disk
(photometric modules) or measuring channel (immune
modules) to which the control is assigned. The displayed
modules can be selected in the Module list box above.
Choose the column header to sort the list by module name.
Test This column displays the short test name of a test that has
been activated in the Install submenu for QC. Choose the
column header to sort the list by test name.
Control This column displays the name of the control used for the
test. Choose the column header to sort the list by control
name.
S. Type This column displays the sample type. Choose the column
header to sort the list by sample type.
Lot ID This column displays the lot number of the control for the
selected test. Choose the column header to sort the list by
lot no.
Cause This column displays the cause for the QC selection. It

turns yellow if a QC is recommended (timeout) by the
26 QC menu
system. Choose the column header to sort the list by

cause.
The following causes are available in descending priority:
Cause Occurrence
Timeout Control interval time expired (QC
measurement is recommended)
Manual QC has been manually selected
y QC causes
Roche Diagnostics
Status submenu 1637
Buttons
Routine QC Assign Use this button to request QC measurements for all

reagent cassettes currently active on the system. Controls
are activated on the QC > Install submenu.
Stand By Bottle QC Use this button to display the Stand By Bottle QC window.
This window is used to select reagent cassettes for
standby QC.
u Stand By Bottle QC window (1638).
Unloading Use this button to unload auto QC racks from the auto QC
compartment. In the Unloading window select the rack(s) to
be unloaded and then choose Execute.
u Unloading auto QC racks from the auto QC
compartment (537)
Save Use this button to update the QC > Status submenu and to
request QC measurements for the selected tests.
26 QC menu
Roche Diagnostics
1638 Stand By Bottle QC window
Stand By Bottle QC window

f QC > Status > Stand By Bottle QC
Use this window to select standby reagent cassettes

currently on a module for QC processing. All tests and
controls for standby reagent cassettes are displayed.
This list displays information for all standby reagent

cassettes currently loaded on the modules. The list can be
sorted by any column by choosing the appropriate column
Select This column displays if the corresponding standby reagent

cassette is selected for QC. If selected, a check mark
appears in this column. Choose the column header to sort
the list by selection.
Module This column displays the module name on which the

corresponding standby reagent cassette is loaded. For the
e 801/e 602, the measuring channel is also displayed.
Choose the column header to sort the list by module name.
Position This column displays the reagent position on which the

26 QC menu
corresponding standby reagent cassette is loaded.

Choose the column header to sort the list by position.
Roche Diagnostics
Stand By Bottle QC window 1639
Status This column displays each reagent’s status of precedence.

Reagents are indicated by SB1, SB2, … SBn, where the
numbers 1, 2, … n refer to the order of registration on the
instrument. The reagent which will be used after the
Current is named SB1, the reagent which will be used after
SB1 is named SB2 and so on. Choose the column header to
sort the list by status.
u For information on the priority of reagent cassettes,
see:
module (403)
module (444)
Test This column displays the short name of the test

corresponding to the standby reagent cassette. Choose
the column header to sort the list by test name.
Control This column displays the name of the control

corresponding to the standby reagent cassette. Choose
the column header to sort the list by control name.
S. Type This column displays the sample type. Choose the column
header to sort the list by sample type.
Lot ID This column displays the lot number of the corresponding

QC material. Choose the column header to sort the list by
lot number.
26 QC menu
Roche Diagnostics
1640 Unloading window
Unloading window
f QC > Status > Unloading
Use this window to select the auto QC rack(s) to be

unloaded. Choose the column header to sort the list by the
Rack No.- Pos. or Control column, respectively.
Select This column displays if the corresponding control is

selected for unloading. If selected, a check mark appears
in this column.
Position This column displays the position of the rack in the auto QC
compartment.
QC material (e.g., Q30016-4 for QC rack Q016, position 4).
A red background indicates that the QC material is expired
(onboard stability is exceeded).
Control This column displays the name of the QC material

corresponding to the auto QC.
26 QC menu
Roche Diagnostics
Run Status submenu 1641
Run Status submenu

f QC > Run Status
The Run Status submenu displays the control results

processed on the data manager. Use the Run Status
submenu to get an overview of the last 500 QC
measurements performed on the instrument or to view the
most recent QC measurements for one particular test
specified.
Use the Test box to select all tests or one specific test to
be displayed on the chart. Use the scroll bar at the bottom
of the chart to move the focus from one result to the next.
Test Select a test from this list box to view information on the
most recent QC measurements for one particular test.
u For further information, see:
Details area (1641)
Chart (1643)
Details area
26 QC menu
The Run Status submenu consists of a details area in the

upper part of the screen and a chart in the lower part of
the screen. The details area in the upper part of the Run
Status submenu displays the following information, which
relates to the QC measurement selected on the run status
chart.
Control This field displays the name of the quality control material.
Roche Diagnostics
1642 Run Status submenu
Lot ID This field displays the lot number of the quality control
material.
Test This field displays the name of the test for which the QC
has been performed.
Module This field displays the module name and reagent disk to
which the reagent cassette is assigned.
R1 R. P. Lot ID - R3 R. P. Lot ID These fields display the lot number of the reagent
cassette.
R1 R. P. Seq. No. - R3 R. P. Seq. No. These fields display the sequence number of the reagent
cassette.
Pos. This field displays the reagent’s position in the reagent

compartment.

Possible values are Current, SB1, SB2, SB3 …
Current Reagent currently in use

current is named SB1

is named SB2
The order of precedence of standby reagents within the

same lot is assessed by the reagents’ time of registration;
the oldest reagent is used first.
Date This field displays the date when the control was
measured.
Time This field displays the time when the control was measured.
SD (High) This field displays the SD upper limit for the selected test.
SD (Low) This field displays the SD lower limit for the selected test.
SD (Value) This field displays the plotted SD-value.

26 QC menu
Result This field displays the result of the QC measurement.
Unit This field displays the unit of measure for result of the QC
measurement.
Roche Diagnostics
Run Status submenu 1643
Chart
The chart in the Run Status submenu displays up to

500 results of QC measurements. The vertical axis of the
graph shows the SD value and the horizontal axis shows the
measurement time by the sequence from left to right.
When there are multiple data of the same time span, the
data is displayed in the sequence of module number.
QC results in the chart The indication of results in the chart is based on the
standard deviation (SD):
• For clinical chemistry:
- Current QC ± 3 SD value range is displayed.
- Standby Bottle QC ± 2 SD value range is displayed
(default value).
• For immunochemistry:
- Current QC ± 3 SD value range is displayed.
- Standby Bottle QC ± 3 SD value range is displayed
(default value).
u For information about asymmetric QC on the e 801
module, see: Checking QC results (529)
Color Red and yellow denote a QC result that falls outside of

relevant limits. Green and blue symbols are used for results
within the relevant limits.
Today
QC result is outside the SD (High/Low) value range.
Today
QC result is within the SD (High/Low) value range.
Past day
QC result is outside the SD (High/Low) value range.
Past day
QC result is within the SD (High/Low) value range.
26 QC menu
Roche Diagnostics
1644 Controls submenu
Controls submenu
f QC > Controls
Use the Controls submenu to view information about

already registered controls and the current rack
assignments.
If you are using controls without a barcode, you must

assign each control to a rack number and position.
u Assigning non-barcoded QC material to rack
positions (535)
q Do not use barcoded controls on racks that have been

assigned for non-barcoded controls. In this case no QC
measurement is performed. The rack is passed through to
Control list
This list displays the rack number and position the control
26 QC menu
is assigned to, the control name, sample type, lot number

and expiry date. It can be sorted by Control or
Rack No. - Pos. by choosing the corresponding column
header.
Control This column displays the control name. Choose the column
header to sort the list by control name.
Roche Diagnostics
Controls submenu 1645
control on the rack (e.g., Q30016-4, for QC rack Q016,
position 4). Choose the column header to sort the list by
rack number.
S. Type This column displays the sample type assigned to the

control.
Lot ID This column displays the lot number of the control.
Exp. Date This column displays the expiry date of the control. Expired
controls show a red background.
Button
Rack Assign Choose this button to display the Rack Assign window. Use
this window to assign a position to a non-barcoded control
(supervisor level).
26 QC menu
Roche Diagnostics
1646 Rack Assign window
Rack Assign window

f QC > Controls > Rack Assign
This window can be accessed by an operator with a

Use this window to assign a control to a rack position.
q Do not use barcoded controls on racks that have been

assigned for non-barcoded controls. In this case no QC
measurement is performed. The rack is passed through to
Control list
Use this list on the left to select the control to be assigned

to the position selected in the rack list.

26 QC menu
Rack No. and position list
Use this list on the right to select a specific rack number

and position. It can be sorted by Rack No. - Pos. or Control.
Rack No. - Pos. This column displays the rack number and position (e.g.,
Q30016-4 for control rack number Q016, position 4).
Choose the column header to sort the list by rack number.
Roche Diagnostics
Rack Assign window 1647
Control This column displays the name of the control currently

assigned to the rack number and position. Choose the
column header to sort the list by control name.
Lot ID This column displays the lot number of the control

assigned to the rack number and position.
Buttons
Add > Choose this button to assign the selected control from the
control list on the left to the selected rack number and
position from the rack list on the right.
< Remove Choose this button to remove the control from the
selected rack number and position.
q A control can be assigned to or removed from more

than one position.
26 QC menu
Roche Diagnostics
1648 Install submenu
Install submenu
f QC > Install
This submenu can be accessed by an operator with a

Use the Install submenu to download controls from the

data manager or delete controls from the instrument.
Furthermore, you can inactivate or activate tests for the
controls.
q It is not possible to add a control manually to the

instrument. The control data must always be downloaded
from the data manager using the Download button.
u For details on the control data, for example, the target mean
values, use the data manager component Control material.
u Installing QC material data from the data

manager (531)
Deactivating tests for QC material (534)
26 QC menu
Control list
The list on the left of the screen displays all controls

installed on the instrument. Up to 100 controls can be
installed on the system.
No. The first column displays a management number.
Roche Diagnostics
S. Type This column displays the sample type assigned to the

control.
Material No. This column displays the code number of the control.
Exp. Date This column displays the expiry date of the control.
Test list
The list on the right of the screen displays whether the

tests are assigned and activated to the control selected on
the left.
Test This column displays the test name. Activated tests show a
blue background.
Buttons
Add Do NOT use this button to add a control to the system. Use
the Download button to install controls.
u See Download window (1652)
u For information on creating a non-Roche control,
please refer to the data manager component Control
material in the Operator’s Manual or the Online Help of
the data manager.
Delete Use this button to delete the selected control(s) after

confirmation.
Detail Use this button to display details about a control selected

from the left list.
u See Detail window (1651)
Download Choose this button to display the Download window used

to add new controls.
Activate Test/Inactivate Test Use this button to activate/inactivate the selected test for
26 QC menu
the selected control. This button toggles between Activate

Test and Inactivate Test depending on the operator
selection. Inactive controls remain in the system but do not
display on the QC charts.
u Deactivating tests for QC material (534)
Roche Diagnostics
1650 Add window
Add window
f QC > Install > Add

Do NOT use this window to add a control to the system. Use

the Download button to install controls.
u For information on creating a non-Roche control,
please refer to the data manager component Control
material in the Operator’s Manual or the Online Help of
the data manager.
q If a line already assigned to a Roche control is

selected, it is possible to edit the current name. No other
details can be edited.
The control data, for example the target mean values, must
always be downloaded from the data manager.
Control Use this text box to enter the control name (up to
10 characters).
S. Type Use this list box to select the sample type to be associated
with the control.
Material No. Use this text box to enter the code number of the control
(801 to 999 or 25 000 to 32 000).
Lot ID Use this text box to enter the control lot number (up to
6 characters).
Exp. Date Use these 2 text boxes to define the expiry date of the
control. One text box is used for the year (0 to 99), the
other is used for the month (1 to 12). The use of each text
box depends on the date settings. In the guidance prompt
you can see which text box is used for the year and which
one for the month.
26 QC menu
Roche Diagnostics
Detail window 1651
Detail window
f QC > Install > Detail
Use this window to display details about a control selected

on the QC > Install submenu. The window shows details for
all module types on which the control with the same Code
and Lot ID is registered.
Control This field displays the name of the selected control.
Material No. This field displays the code number of the control.
Lot ID This field displays the lot number of the control.
Module Type This field displays on which module types the control with
the same Material No. and Lot ID is registered.
Exp. Date This field displays the expiry date of the control.
Version This field displays the version number of the control

parameters.
Release Date This field displays the date when this version of the control
was released.
26 QC menu
Roche Diagnostics
1652 Download window
Download window
f QC > Install > Download

Use this window to download new control data or update

control data from the data manager.
manager (531)
Supervisors may download parameters for the newest and

current release of an already installed control. Supervisors
can neither download parameters for an older release nor
parameters for a different control. Administrators may
download any available control parameters.
Supervisor Administrator
Update control lot to newest release l l
Download current release of control lot again l l
Download different control lot for an already installed l l
control (same material number)
Download any control and release – l
26 QC menu
y User rights for downloading control parameters
Search Using area
This area displays the search criteria.
All Item Select the control directly from a list of all controls. Only
the controls for the installed tests are displayed.
Roche Diagnostics
Required Item This search option lists all controls that are on board but
for which the control information was not yet downloaded.
This function works identical to the Parameter Download
window.
Control This search option displays the Control list box. Select the
desired control from the list box.
Lot ID This search option displays the Lot ID text box. Enter the
lot number of the control you are searching for.
Result area
This area displays the results that match the search

criteria.
Selection This column displays whether the corresponding control is

selected for downloading. If selected, a check mark
appears in this column.
Control This column displays the name of the control. Choose the
column header to sort the list by control name.
Buttons
Search Use this button to search for control parameters with the
selected search options.
After a successful search, a table appears in the Result

area. This table displays all controls that match the search
criteria.
Download Use this button to download the control parameters from

the data manager. 26 QC menu
Roche Diagnostics
1654 Confirmation window
Confirmation window
f QC > Install > Download > Download
Use this window to verify the selection before the control

parameters are downloaded. With an administrator level
password, you can select the desired release of the
control parameters.
manager (531)
Control This line displays the name of the control.
Material No. This line displays the code number of the control.
Lot ID This line displays the lot number of the control.
Module Type This line displays for which module types the control with
the same Material No. and Lot ID can be downloaded.
Exp. Date This line displays the expiry date of the control lot.
Version This line displays the version number of the control

parameters.
26 QC menu
Current Release Date This field displays the release date of the control lot
currently on board. This is only available if the same control
lot is requested for download.
Roche Diagnostics
Addition Release Date/ This list box displays the release that will be newly
Update Release Date installed. Administrators may select other available
releases. The newest one is always on top. Select None
from the list box if you want to skip downloading the
parameters for a specific module.
The Addition Release Date list box is only displayed if a new
control is added.
The Update Release Date list box is only displayed if an
existing control is updated.
26 QC menu
Roche Diagnostics
1656
26 QC menu Confirmation window
Roche Diagnostics
1657
Table of contents
Utility menu 27
This chapter provides a detailed description of the Utility

menu and the windows accessed from it. All system and
application parameters are set via the Utility menu. In
addition, maintenance functions, such as pipes, as well as
the individual maintenance actions are accessed from this
menu.
In this chapter 27
System submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1661
Input Operator ID window . . . . . . . . . . . . . . . . . . . . . . . . 1664
Operator List window. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1665
Access levels of each menu and window . . . . . . . . . . . 1666
Add window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1675
Password Protection window . . . . . . . . . . . . . . . . . . . . . 1676
Rack Assignment window . . . . . . . . . . . . . . . . . . . . . . . . 1677
Standard tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1679
Non-Standard tab . . . . . . . . . . . . . . . . . . . . . . . . . . . 1680
False Bottom tabs 1, 2, 3 . . . . . . . . . . . . . . . . . . . . . 1682
Module Settings tab . . . . . . . . . . . . . . . . . . . . . . . . . 1684
False Bottom Settings window . . . . . . . . . . . . . . . . . . . . 1686
27 Utility menu
Barcode Settings window . . . . . . . . . . . . . . . . . . . . . . . . 1688

Data Manager Settings window . . . . . . . . . . . . . . . . . . . 1690
Communication Settings tab . . . . . . . . . . . . . . . . . . 1691
Text Settings tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1692
Test Selection Inquiry Settings tab . . . . . . . . . . . . . 1693
Key Settings window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1695
Test Key Setting window . . . . . . . . . . . . . . . . . . . . . . . . . 1697
Profile Setting window. . . . . . . . . . . . . . . . . . . . . . . . . . . 1698
Print Settings window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1700
Roche Diagnostics
1658
Table of contents
Comment Titles window . . . . . . . . . . . . . . . . . . . . . . . . . 1701

Display Settings window . . . . . . . . . . . . . . . . . . . . . . . . . 1702
Rack Reception window . . . . . . . . . . . . . . . . . . . . . . . . . 1704
Analyzer Settings window . . . . . . . . . . . . . . . . . . . . . . . . 1706
Wash Racks window (chemistry). . . . . . . . . . . . . . . . . . . 1707
Rack Delivery window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1708
Maintenance Settings window . . . . . . . . . . . . . . . . . . . . 1710
Edit window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1711
Pipe Settings window. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1713
Edit window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1715
Power Up Pipe window. . . . . . . . . . . . . . . . . . . . . . . . . . . 1717
Reagent Manager Settings window (c 702 module) . . 1718
Immune Analyzer Settings (e 801 module). . . . . . . . . . 1719
Alarm Settings window . . . . . . . . . . . . . . . . . . . . . . . . . . 1722
Result Upload Settings window . . . . . . . . . . . . . . . . . . . 1725
Calib. and QC Settings window . . . . . . . . . . . . . . . . . . . 1727
Reagent Level window. . . . . . . . . . . . . . . . . . . . . . . . . . . 1729
Utility Reagent Settings window (photometric) . . . . . . 1731
Special Reagent tab . . . . . . . . . . . . . . . . . . . . . . . . . 1731
Dilution tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1733
Detergent tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1734
R. Packs Setting window (c 701/c 702 module). . . . . . 1736
R. Packs Setting window (c 502) . . . . . . . . . . . . . . . . . . 1738
ISE Calib. Settings window . . . . . . . . . . . . . . . . . . . . . . . 1740
Reagent Loading Level window (c 702) . . . . . . . . . . . . 1741
Maintenance submenu . . . . . . . . . . . . . . . . . . . . . . . . . . 1744
Maintenance Monitor window. . . . . . . . . . . . . . . . . . . . . 1746
Maintenance item windows. . . . . . . . . . . . . . . . . . . . . . . 1747
Reset window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1748
Rack Reset window . . . . . . . . . . . . . . . . . . . . . . . . . . 1749
27 Utility menu
Photometer Check window. . . . . . . . . . . . . . . . . . . . 1750

Cell Blank Measurement window . . . . . . . . . . . . . . . 1751
Incubation Water Exchange window . . . . . . . . . . . . 1752
Air Purge window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1753
Wash Reaction Parts window . . . . . . . . . . . . . . . . . . 1754
Reagent Prime window . . . . . . . . . . . . . . . . . . . . . . . 1755
Cell Detergent Prime window . . . . . . . . . . . . . . . . . . 1757
Incubator Bath Cleaning window . . . . . . . . . . . . . . . 1758
Manual Cleaning window . . . . . . . . . . . . . . . . . . . . . 1759
Change Reaction Cell window . . . . . . . . . . . . . . . . . 1761
Change Photometer Lamp window . . . . . . . . . . . . . 1762
Parameter Read/Write window. . . . . . . . . . . . . . . . . 1763
Roche Diagnostics
1659
Table of contents
Test Count Write window. . . . . . . . . . . . . . . . . . . . . . 1764

QC Timer Reset window . . . . . . . . . . . . . . . . . . . . . . 1765
System Wash window . . . . . . . . . . . . . . . . . . . . . . . . 1766
Sample Probe Wash window. . . . . . . . . . . . . . . . . . . 1767
Reagent Probe Wash window . . . . . . . . . . . . . . . . . . 1768
Bead Mixer Rinse window . . . . . . . . . . . . . . . . . . . . . 1769
e 602/e 801 Reagent Wash window . . . . . . . . . . . . 1770
Pipetter Air Purge window . . . . . . . . . . . . . . . . . . . . 1771
Sipper Air Purge window . . . . . . . . . . . . . . . . . . . . . . 1772
MC Preparation window. . . . . . . . . . . . . . . . . . . . . . . 1773
MC Exchange window . . . . . . . . . . . . . . . . . . . . . . . . 1774
Liquid Flow Cleaning window . . . . . . . . . . . . . . . . . . 1775
Inventory Update window . . . . . . . . . . . . . . . . . . . . . 1776
ISE System Wash window . . . . . . . . . . . . . . . . . . . . . 1777
Pre-wash Sipper Rinse window. . . . . . . . . . . . . . . . . 1778
Pre-wash Sipper Air Purge window . . . . . . . . . . . . . 1779
Finalization window . . . . . . . . . . . . . . . . . . . . . . . . . . 1780
Empty PC/CC Reservoir window. . . . . . . . . . . . . . . . 1781
Initial Bead Mixing window . . . . . . . . . . . . . . . . . . . . 1782
Reagent Capping window . . . . . . . . . . . . . . . . . . . . . 1783
AssayCup Discarding window. . . . . . . . . . . . . . . . . . 1784
System Air Purge (e 602/e 801) window. . . . . . . . . 1785
System Prime (e 602/e 801) window . . . . . . . . . . . . 1786
Maintenance check windows . . . . . . . . . . . . . . . . . . . . . 1787
Disk Check window. . . . . . . . . . . . . . . . . . . . . . . . . . . 1788
ISE Check window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1789
Mechanism Check window . . . . . . . . . . . . . . . . . . . . 1790
Probe Check window . . . . . . . . . . . . . . . . . . . . . . . . . 1791
ISE Probe Check window. . . . . . . . . . . . . . . . . . . . . . 1793
Sample Barcode Reader Check window . . . . . . . . . 1794
Reagent ID Reader Check window. . . . . . . . . . . . . . 1795
R. Pack Loading Check window . . . . . . . . . . . . . . . . 1796
Cuvette Mixing window . . . . . . . . . . . . . . . . . . . . . . . 1797
Reagent Short Sensor Check window. . . . . . . . . . . 1798
Sample Pipetting Check window . . . . . . . . . . . . . . . 1799
Reagent Pipetting Check window . . . . . . . . . . . . . . 1800
Cap Opener Check window . . . . . . . . . . . . . . . . . . . 1801
Bead Mixer Check window . . . . . . . . . . . . . . . . . . . . 1802
Gripper Check window . . . . . . . . . . . . . . . . . . . . . . . 1803
Magazine Exchange Check window. . . . . . . . . . . . . 1804
27 Utility menu
Sipper Check window . . . . . . . . . . . . . . . . . . . . . . . . 1805

Pre-wash Probe Check window . . . . . . . . . . . . . . . . 1806
Pre-wash Gripper Check window . . . . . . . . . . . . . . . 1807
Sipper Gripper Check window . . . . . . . . . . . . . . . . . 1808
Reagent Loader Check window . . . . . . . . . . . . . . . . 1809
Reagent Handling Check window . . . . . . . . . . . . . . 1810
Urgent Information window. . . . . . . . . . . . . . . . . . . . 1811
Essential Information Upload window . . . . . . . . . . . 1812
Database Backup window . . . . . . . . . . . . . . . . . . . . . 1813
Program Update window . . . . . . . . . . . . . . . . . . . . . . 1814
Roche Diagnostics
1660
Table of contents
Application submenu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1816

Options, lists, buttons . . . . . . . . . . . . . . . . . . . . . . . . 1817
Analyze (photometric tests) . . . . . . . . . . . . . . . . . . . 1819
Analyze (serum indices). . . . . . . . . . . . . . . . . . . . . . . 1825
Analyze (immune tests) . . . . . . . . . . . . . . . . . . . . . . . 1827
Calib. (ISE tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1828
Calib. (photometric tests) . . . . . . . . . . . . . . . . . . . . . 1830
Calib. (immune tests) . . . . . . . . . . . . . . . . . . . . . . . . . 1834
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1837
Other (ISE tests). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1841
Other (photometric tests). . . . . . . . . . . . . . . . . . . . . 1842
Formula (Compensated Test) . . . . . . . . . . . . . . . . . . 1844
R. Packs Setting window (c 701/c 702). . . . . . . . . . . . . 1846
R. Packs Setting window (c 502) . . . . . . . . . . . . . . . . . . 1848
Download window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1850
Special Wash submenu (photometric and e 602 tests) 1855
Reagent Probe window (photometric). . . . . . . . . . . . . . 1857
Edit (Reagent Probe) window (photometric). . . . . . . . . 1860
Reagent Probe window (e 602) . . . . . . . . . . . . . . . . . . . 1862
Edit (Reagent Probe) window (e 602) . . . . . . . . . . . . . . 1865
Cell window (photometric) . . . . . . . . . . . . . . . . . . . . . . . 1867
Edit (Cell) window (photometric) . . . . . . . . . . . . . . . . . . 1870
Sample Probe window . . . . . . . . . . . . . . . . . . . . . . . . . . . 1871
Edit (Sample Probe) window . . . . . . . . . . . . . . . . . . . . . . 1873
Download window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1874
System Configuration submenu . . . . . . . . . . . . . . . . . . . 1876
Test Assignment window . . . . . . . . . . . . . . . . . . . . . . . . . 1877
Test Assignment (ISE) window . . . . . . . . . . . . . . . . . . . . 1878
Test Assignment (c 701/c 702) window . . . . . . . . . . . . 1879
Test Assignment (c 502) window . . . . . . . . . . . . . . . . . . 1881
Test Assignment (e 801) window . . . . . . . . . . . . . . . . . . 1882
27 Utility menu
Test Assignment (e 602) window . . . . . . . . . . . . . . . . . . 1884

Module Settings window . . . . . . . . . . . . . . . . . . . . . . . . . 1886
CLAS Settings window. . . . . . . . . . . . . . . . . . . . . . . . . . . 1887
Roche Diagnostics
System submenu 1661
System submenu
f Utility > System
This submenu is used to define system settings. An

Administrator level password is required to display the
Utility > System submenu.
The Utility > System submenu consists of two areas:

• System Settings Menu (upper area)
• Analytical Settings Menu (lower area)
Buttons – System Settings Menu area
Operator List Choose this button to assign user IDs and the
corresponding access levels. The Operator List window
provides a list of all currently assigned users.
If password protection is off (which is not recommended),

you do not have to enter a logon name and password to
access the software. In this case the Input Operator ID
window is displayed when choosing the Operator List
button.
27 Utility menu
When password protection is off, the operator level is

Administrator.
u Operator List window (1665)
Rack Assignment Choose this button to assign rack ranges and tube types
(standard, non-standard, or false bottom tube) for each
sample type (Ser/Pl, Urine, CSF…). Furthermore, calibrator
and control racks may optionally be assigned to specific
modules.
u Rack Assignment window (1677)
Roche Diagnostics
1662 System submenu
Barcode Settings Choose this button to enable/disable barcode check digits

and to specify the type(s) of check digit(s).
u Barcode Settings window (1688)
Data Manager Settings Choose this button to set the data manager interface
parameters.
u Data Manager Settings window (1690)
Key Settings Choose this button to assign up to 6 groups of 32 tests

and to assign profiles to the various sample types.
u Key Settings window (1695)
Print Settings Choose this button to define the paper format and to
select information to be included in the printouts.
u Print Settings window (1700)
Comment Titles Choose this button to define the titles for the
5 demographic comments. These comments appear, for
example, on the Sample Information windows of the Test
Selection and Data Review submenus. The main comment is
also defined here.
u Comment Titles window (1701)
Display Settings Choose this button to set the date and time of the control
unit computer and to define display settings.
u Display Settings window (1702)
Rack Reception Choose this button to activate or cancel Rack Reception

mode and Photometric Stop Washing and to set the time
period.
u Rack Reception window (1704)
Analyzer Settings (chemistry) Choose this button to specify the reaction cell that is used
for the next analysis run.
u Analyzer Settings window (1706)
Wash Racks (chemistry) Choose this button to specify the number of washing
cycles for the sample probe and the ISE flow path.
27 Utility menu
u Wash Racks window (chemistry) (1707)
Rack Delivery Choose this button to set the number of slots reserved for
STAT racks and to activate the sample tube rotation
function. Choose this button also to set the height for the
backup operation tubes and to limit the number of racks to
be loaded onto the instrument.
u Rack Delivery window (1708)
Maintenance Settings Choose this button to define maintenance types, or to

delete or edit existing ones.
u Maintenance Settings window (1710)
Roche Diagnostics
System submenu 1663
Pipe Settings Choose this button to create a new maintenance pipe, or

to edit or delete an existing one. Select the maintenance
pipe to be performed at power on by day of week.
u Pipe Settings window (1713)
Reagent Manager Settings (c 702 module) Choose this button to define the settings of the reagent
manager and to set the number of slots for reagent
cassette transfer on the reagent disk.
u Reagent Manager Settings window (c 702
module) (1718)
Immune Analyzer Settings (e 801 module) Choose this button to activate the quick start mode and to
define the reagent expired mask settings.
u Immune Analyzer Settings (e 801 module) (1719)
Buttons – Analytical Settings Menu area
Alarm Settings Choose this button to define alarm parameters.

u Alarm Settings window (1722)
Result Upload Settings Choose this button to define the upload settings used for
the transfer of result data from the instrument to the data
manager.
u Result Upload Settings window (1725)
Calib. and QC Settings Choose this button to define QC settings and to activate
calibration masking.
u Calib. and QC Settings window (1727)
Reagent Level Choose this button to define the level of reagent at which a
yellow or purple reagent level alarm is issued.
u Reagent Level window (1729)
Utility Reagent Settings (c 701, c 702, c 502 Choose this button to confirm and update the registration
module) status of system reagents.
u Utility Reagent Settings window (photometric) (1731)
27 Utility menu
ISE Calib. Settings (ISE module) Choose this button to set an ISE calibration curve that is
used for the different sample types. On the instrument, two
calibration curves can be measured.
u ISE Calib. Settings window (1740)
Reagent Loading Level (c 702 module) Choose this button to define the Yellow Loading Limit and
the Initial Loading Limit for tests on each reagent disk.
u Reagent Loading Level window (c 702) (1741)
Roche Diagnostics
1664 Input Operator ID window
Input Operator ID window

f Utility > System > Operator List
The Input Operator ID window is only displayed if password

protection is switched off. (In case it is switched on, the
Operator List window is displayed.)
When password protection is off, the operator level is

Administrator.
Use this window in order to activate password protection.

After confirmation with OK, the Password Protection
window is displayed.
u Password Protection window (1676)
Operator ID Use this text box to enter your operator ID.
Password Use this text box to enter your password. Confirm with OK.
u Related topics
• Operator List window (1665)
• Access levels of each menu and window (1666)
27 Utility menu
Roche Diagnostics
Operator List window 1665
Operator List window

f Utility > System > Operator List
q Losing access to the instrument.

At least one administrator level logon ID must remain in the
control unit at all times.
This window is used to assign operator IDs and access

levels (security levels).
q Once an operator ID is established, the password that

the operator uses to log on for the first time remains
permanently linked to this operator ID.
Therefore, if the password for an existing operator gets
lost, this ID must be deleted and reprogrammed.
Operator List This list displays IDs with their access levels currently
defined on the system. Levels include Administrator,
Supervisor and Operator and allow the user different
access rights to menus, windows, and other functions in
the software. Up to 40 IDs can be defined.
u Access levels of each menu and window (1666)
Buttons
Add Use this button to display the Add window. This window is
used to add a new operator ID to the system.
u Add window (1675)
Delete Use this button to delete the selected ID from the system
after confirmation.
27 Utility menu
Delete operator IDs from the system for users who no

longer work on the system.
Password Protection Use this button to switch password protection on or off.

This button is not available for administrators. If you want
to deactivate password protection, please contact your
local Roche service representative.
u Password Protection window (1676)
Roche Diagnostics
1666 Access levels of each menu and window
Access levels of each menu and window

The instrument software provides 3 levels of access, which
are shown in the following table.
q Assign access rights to each user only as high as

necessary.
Access level Access rights

Administrator System configuration and maintenance settings
Administrator
Supervisor Basic system and application settings
Supervisor Operator Access to routine operation and maintenance functions without
system settings
Operator
y Access levels
Abbreviations These abbreviations are used in the following access level

tables.
Access level O: Operator

S: Supervisor
A: Administrator
Access rights -: not accessible

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
Access levels of each menu and window 1667
Workplace menu
Submenu Button/window Purpose O S A

Test Selection Register sample test and check/change rerun item e e e
Sample Information Enter demographic data e e e
Barcode Read Error Enter sample data in case of barcode read error e e e
Rerun Rack Assignment Assign rerun rack no. and position (non-barcode mode) e e e
Repeat Assign same request for multiple samples e e e
Data Review Check measurement result e e e
Data Select the data base to be displayed e e e
Sample Information Enter demographic data e e e
Search Search for the sample result e e e
Filter Filter sample results e e e
Send to DM Transmit results to data manager system e e e
Delete Record Delete individual results e e e
Delete All Delete all results e e e
Backup Data Save results to disk e e e
Test Review Check and edit sample results e e e
o Reagent Detail e e e
o Original Data e e e
o All Results e e e
Reaction Monitor View photometric reaction curve e e e
o Scale e e e
o Overlay e e e
y Access levels of the windows in the Workplace menu
Abbreviations
S: Supervisor
A: Administrator

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
Reagent menu

Setting Check reagent setting e e e
Reagent Manager Overview View status of reagent cassettes on the reagent manager and e e e
control these reagent cassettes manually
Reagent Registration e e e
Reagent Prime Reagent exchange e e e
Manual Registration Manual registration of reagent e e e
Reagent Volume Reset e e e
Delete Delete reagent from list e e e
R. Pack Set Information e e e
R. Pack Unloading Unload a reagent cassette manually e e e
Development Channel Assign a cobas c pack MULTI to a Development Channel e e e
application
Status Check reagent status e e e
Inventory Setting Enter ProCell lot No. e e e
Reagent Volume Reset Reset the remaining volume of detergents (photometric e e e
modules) or ISE reagents.
y Access levels of the windows in the Reagent menu
Abbreviations
S: Supervisor
A: Administrator

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
Calibration menu

Status Save, check and change test calibrations e e e
Reject Reject calibration result e e e
Calibration Trace Trace of calibration result e e e
o Scale e e e
o Comment e e e
Calibration Result (Photometry) Display a list of calibration results r e e
o Working Information Display the calibration curve r e e
Calibration Result (ISE) Display the results from the most recent successful calibration e e e
Calibration Result (Immune) Display the results from the most recent calibration r e e
Reaction Monitor View photometric reaction curve e e e
o Send to DM e e e
o Scale e e e
Instrument Factor Enter a coefficient for correction of difference between r e e
instruments
Start up Setting Check and save startup calibrations r e e
Calibrators Check and add rack to set calibrator e e e
Rack Assign Add and delete rack no. and position r e e
Install Chemistry Addition and change of test for each calibrator e e e
o Add Add calibrator r e e
o Delete Delete calibrator r e e
o Edit Edit calibrator r e e
o Download Download calibrator information r e e
Immune Addition and deletion of calibrators e e e
o Delete Delete calibrator r e e
o Download Download calibrator information r e e
y Access levels of the windows in the Calibration menu
Abbreviations
S: Supervisor
A: Administrator

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
QC menu

Status Save, check and change test quality control e e e
Stand By Bottle QC Set QC for standby reagent cassette e e e
Unloading Unloads automatic QC racks e e e
Run Status e e e
Controls Check and add rack to set control e e e
Rack Assign Add and delete rack no. and position - e e
Install Add and change test for QC sample - e e
Add Add new QC sample manually - e e
Delete Delete QC sample - e e
Download Download new QC sample - e e
Inactivate/Activate Test Select test for QC sample - e e
y Access levels of the windows in the QC menu
Abbreviations
S: Supervisor
A: Administrator

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
Utility menu

System > System Configure instrument - - e
Settings Menu Operator List Assign operator IDs - - e
o Add - - e
o Delete - - e
o Password Protection - - r
Rack Assignment Change rack assignment - - e
o False Bottom Settings - - e
Barcode Settings Change barcode settings - - e
Data Manager Settings Configure data manager communication parameters - - e
Key Settings Set test groups and test key - - e
o Test Key Settings - - e
o Profile Setting - - e
Print Settings Set parameters for printouts - - e
Comment Titles Define comment titles - - e
Display Settings - - e
Rack Reception Set Rack Reception mode - - e
Analyzer Settings Reset start cell number - - e
(Variable Start Cell No.)
Wash Racks Set parameters for washing with green rack - - e
Rack Delivery Set STAT rack number, activate sample tube rotation function, - - e
and define sample tube height for backup operation.
Maintenance Settings View maintenance item - - e
o Edit Define maintenance item parameters - - e
Pipe Settings Define maintenance pipes - - e
o Edit Define pipe item parameters - - e
o Parameter - - e
o Power Up Pipe Set maintenance pipe for power up - - e
Reagent Manager Settings Define reagent manager settings - - e
System > Analytical Alarm Settings Set alarm settings - - e
Settings Menu Result Upload Settings Define timing for upload to the data manager - - e
Calib. and QC Settings Set automatic masking for calibration and auto QC - - e
Reagent Level Set reagent check levels - - e
Utility Reagent Settings Confirm the registration status of diluents and cleaners - - r
Development Channel - - e
27 Utility menu
R. Pack Setting - - r
ISE Calib. Settings Set an ISE calibration curve - - e
Reagent Loading Level Set reagent check levels - - e
Maintenance Execute maintenance e e e
Maintenance Monitor Monitor current maintenance action e e e
Select Specify module for maintenance e e e
y Access levels of the windows in the Utility menu
Roche Diagnostics

Application Register application parameters - r r
Development Channel - r e
R. Packs Setting - - r
Delete Delete application - - e
Download Download new applications - - e
Special Wash Define carryover evasion actions - r e
Reagent Probe (Photometric) - e e
o Edit Edit Reagent - r e
o Delete Delete Reagent - r e
Reagent Probe (Immune) Define carryover evasion actions - r e
o Edit Edit Reagent and Sample - - e
o Delete Delete Reagent and Sample - - e
Cell - e e
o Edit Edit Cell - r e
o Delete Delete Cell - r e
Sample Probe - e e
o Edit Edit Sample - r e
o Delete Delete Sample - r e
Download - - e
System Configuration Set module operating conditions - - e
Test Assignment Assign parameters to modules - - e
Module Settings Set module masking - - e
CLAS Settings Set connection to laboratory automation system - - r
y Access levels of the windows in the Utility menu
Abbreviations
S: Supervisor
A: Administrator

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
Overview menu
Area Button/window Purpose O S A

Work Flow Guide Perform pre-routine tasks and indicate status of modules e e e
Daily Maintenance Jump to Maintenance menu e e e
Sample Data Clear Delete all sample data e e e
Reagent Preparing Print Reagent Load/Unload List or perform a reagent prime e e e
o Reagent Detergent Reset detergent volumes after replacement
Volume Reset
Calib. and QC Select Request calibration and QC and print load lists e e e
Parameter Download Download parameters from the data manager r e e
Sample Tracking Check sample status e e e
Module Overview Module Alarm List and Cancel Maintenance for this module e e e
Reagent Overview Indicate status of reagents and inventory e e e
Reagent Manager Overview View status of reagent cassettes on the reagent manager and e e e
control these reagent cassettes manually
Reagent Pack Unloading Area View status of reagents on the unloading tray of the reagent e e e
manager
Temperature (e 801/e 602) Show temperature values r r r
y Access levels of the windows in the Overview menu
Abbreviations
S: Supervisor
A: Administrator

r: Read only
e: Edit
27 Utility menu
Roche Diagnostics
Global buttons and windows
Window Button/window Purpose O S A

Stop Specify operation stop e e e
Logoff e e e
Logon e e e
S. Stop Specify sample stop e e e
Alarm Review alarm list and remedy e e e
Maintenance Jump to Maintenance menu e e e
Delete Delete alarm e e e
New Alarm Update alarm list e e e
Sound Adjust buzzer sounds e e e
Monitor View results e e e
Print Print reports for each menu e e e
Workplace Print routine measurement data e e e
Reagent Print reagent data e e e
Calibration Print calibration data e e e
QC Print QC data e e e
Utility Print utility data e e e
History Display reports on screen e e e
Backup Backup reports e e e
Print Out e e e
Start Enter analysis start conditions e e e
Change (Start Up Pipe Setting) e e e
Change (Automatic Rerun) - e e
Change (Time To Unload) Set time for unloading reagent cassettes from c 702 e e e
Change (Rack Reception) e e e
Change (CLAS Connection) Disable connection to laboratory automation system e e e
Masking Mask test per channel e e e
Module Masking e e e
Default Profile Define default profiles - - e
y Access levels of the global windows
Abbreviations
S: Supervisor
A: Administrator
27 Utility menu

r: Read only
e: Edit
Roche Diagnostics
Add window 1675
Add window
f Utility > System > Operator List > Add
Use this window to add a new operator ID to the system. Up

to 40 IDs can be assigned.
Operator ID Use this text box to enter an operator ID (up to

16 characters).
Level Use this list box to select the access level for the new
operator ID. Levels include Administrator, Supervisor and
Operator (in descending order of access rights). When
assigning operator IDs, it is important to provide the user
with the correct access level for the tasks to be performed.
u Related topics
• Access levels of each menu and window (1666)
27 Utility menu
Roche Diagnostics
1676 Password Protection window
Password Protection window

f Utility > System > Operator List > Password Protection
Use this window to switch password protection on or off for

all users. When the setting is changed, the instrument
software will be restarted.
When password protection is off (which is not

recommended), the operator level is Administrator.
u Related topics
• Input Operator ID window (1664)
• Operator List window (1665)
27 Utility menu
Roche Diagnostics
Rack Assignment window 1677
Rack Assignment window

f Utility > System > Rack Assignment
Use the Rack Assignment window to assign rack ranges for

routine, rerun and STAT samples for each sample type
(Ser/Pl, Urine, CSF, …). The rack assignment must be done
for standard tubes, non-standard tubes, and false bottom
tubes.
The assignment is used to determine the sample type and

the classification (routine, rerun, STAT) when the rack
number is read after loading.
S. Type The following table specifies the possible sample types for
each module.
Line Sample type ISE module cobas c modules e 801 module e 602 module
1 Ser/Pl Serum/plasma l l l l
2 Urine Urine l l l l
3 CSF Cerebrospinal fluid l l l –
4 Suprnt(1) Supernatant l l l –
27 Utility menu
5 Others(2) Others l l l l
6 WhlBld Whole blood – – l –
7 OraFlu Oral fluid – – l –
8 Hemoly Hemolysate – – l –
9 AmniF Amniotic fluid – – l –
10 Stool Processed stool – – l –
y Possible sample types for each module
(1) On the c 502 module, this line is also used for whole blood.
(2) The sample type is designed for other body fluids than those mentioned for the specific module.
Roche Diagnostics
1678 Rack Assignment window
• Suprnt: Use this sample type for supernatants or for

whole blood on c 502 modules.
• Others: Use this sample type for other body fluids than
mentioned above. If you select the sample type Others,
the instrument always takes the application data of
Ser/Pl set in Utility > Application. The application must
be available for Ser/Pl.
q For each test, only four sample types can be defined.
If you want to mix different sample types on one sample

rack, use the None fields to assign the respective rack ID
range. In this case, the host must send the sample type
information.
Specifications of containers (2031)
Furthermore, use the Module Settings tab for an optional

assignment of calibrator racks and control racks to each
module.
q If data is remaining on the Data Review submenu, you

are prompted to perform a Sample Data Clear prior to
making changes.
In this section
Standard tab (1679)
Non-Standard tab (1680)
False Bottom tabs 1, 2, 3 (1682)
Module Settings tab (1684)
27 Utility menu
Roche Diagnostics
Standard tab
f Utility > System > Rack Assignment
Use the Standard tab to assign rack ranges for routine

testing, rerun, and STAT measurements and for all sample
types (Ser/Pl, Urine, CSF…) used.
The following containers are standard containers:

• Primary tubes (∅13 mm or 16 mm, height 75 mm or
100 mm)
• Sample Cups
• Micro cups
• Sample Cups or micro cups on primary tubes
q The instrument cannot detect micro cups by their

dimension. You must select the Micro option in Workplace
> Test Selection or on the host.
q The rack ranges within a run type (routine, rerun,

27 Utility menu
STAT) must be unique for each sample type (Ser/Pl, Urine,

CSF…).
No Rotation, Rotation areas
No Rotation Use this area to assign rack ranges for standard racks.
When using standard racks, ensure that the center of the
barcode label and the open slot are always in line. The
system can only read the barcode if the label is correctly
positioned. Otherwise, a barcode read error will be issued.
Roche Diagnostics
Rotation Use this area to assign rack ranges for racks without
stabilizers. When using racks without stabilizers the system
rotates the sample tubes to read the barcode. This is only
possible if Sample Tube Rotation is activated on Utility
> System > Rack Delivery.
Routine, Rerun, STAT areas
For each run type (routine, rerun, STAT), the first text box is
used for the first rack number of the range and the second
text box for the last rack number of the range.
Routine Use these text boxes to assign rack ranges (50 001 to
50 999, 60 000 to 60 999, 70 000 to 70 999, or 80 000 to
80 999) to each sample type for routine testing.
Rerun Use these text boxes to assign rack ranges (1 to 999) to

each sample type for rerun testing in non-barcode mode.
STAT Use these text boxes to assign rack ranges (40 001 to
40 999) to each sample type for STAT testing.
u Related topics
range (565)
Non-Standard tab
f Utility > System > Rack Assignment > Non-Standard
27 Utility menu
Roche Diagnostics
Use the Non-Standard tab to assign rack ranges for routine

testing, rerun, and STAT measurements and for all sample
types (Ser/Pl, Urine, CSF, …) used. Racks assigned in this
tab must be used with non-standard sample tubes only.
Please contact your Roche representative for more

information about the use of non-standard tubes and other
sample containers.
Racks assigned in this tab must be used with non-standard

sample tubes. It is possible to use different kinds of non-
standard tubes and to mix these on a rack. However, it is
not permissible to use cup-on-tube on the racks specified
here.
50 999, 60 000 to 60 999, 70 000 to 70 999, or 80 000 to
80 999) to each sample type for routine testing. The racks
27 Utility menu
within these ranges must be used with non-standard

sample tubes.

The racks within these ranges must be used with non-
standard sample tubes.
40 999) to each sample type for STAT testing. The racks
within these ranges must be used with non-standard
sample tubes.
Roche Diagnostics
False Bottom tabs 1, 2, 3

f Utility > System > Rack Assignment > False Bottom 1, 2, 3
Racks assigned in these tabs must be used with false

bottom tubes only.
There are some module-specific differences regarding the

use of false bottom tubes:
• For c 701/c 702 and e 801 modules: Three different
FBT types can be defined for patient samples (see
exception below).
- Alternatively, the whole instrument can be
configured to use 1 FBT type either for auto QCs or
for manual QCs (False Bottom 1 tab).
- In this case, only the False Bottom 2 and False
Bottom 3 tabs can be used for patient samples.
- The usage of FBT for controls can be configured
only by Roche Service representatives or technical
support.
• For c 502 and e 602 modules:
27 Utility menu
- Only 1 FBT type can be used, which is defined on

Utility > System > Rack Assignment > False Bottom 1.
- For c 701/c 702 modules, the FBT type can be used
for patient samples, or if configured by Roche, for
auto QCs or for manual QCs.
If you use cups on non-standard tubes, it is important to

use only one type of non-standard tubes. For the
instrument and the software configuration, it does not
matter whether you use cups on non-standard tubes.
Roche Diagnostics
The tube specifications must be entered in the False

Bottom Settings window. To open this window, choose the
False Bottom Settings button.
u False Bottom Settings window (1686)
50 999, 60 000 to 60 999, 70 000 to 70 999, or 80 000 to
80 999) to each sample type for routine testing. The racks
within these ranges must be used with cups on false
bottom tubes only.

The racks within these ranges must be used with cups on
false bottom tubes only.
40 999) to each sample type for STAT testing. The racks
within these ranges must be used with cups on false
27 Utility menu
bottom tubes only.
Button
False Bottom Settings Choose this button to make settings for false-bottom
tubes or cups on non-standard tubes. These include
settings for container height and bottom level.
u False Bottom Settings window (1686)
Roche Diagnostics
Module Settings tab

f Utility > System > Rack Assignment > Module Settings
Use these text boxes to assign rack ranges to calibrators

and controls for each module. These fields may be used to
optimize calibrator and QC rack handling.
Module Specific Racks area
These are optional fields to be used to force a calibrator or

control rack to a certain module.
For each module, the first text box is used for the first rack
number of the range and the second text box for the last
rack number of the range.
Module This column displays the name of each module installed on

the system.
Calibrator Use these text boxes to assign rack ranges (20 001 to
20 999) for calibrator racks for a particular module. If 0 - 0
is entered in all Calibrator fields, any calibrator rack
27 Utility menu
number can be processed on any module.
Control Use these text boxes to assign rack ranges (30 001 to
30 999) for control racks for a particular module. If 0 - 0 is
entered in all Control fields, any control rack number can
be processed on any module.
Roche Diagnostics
Auto. QC Racks area
QC racks assigned here will remain in the auto QC buffer

and get used whenever a QC measurement is requested
and the auto QC rack holds the appropriate control
material.
Auto. QC Use these text boxes to specify the range of rack numbers
(30 001 to 30 999) for racks that are to be used for auto
QC measurements.
The first text box is used for the first rack number of the
range and the second text box is used for the last rack
number of the range.
positions (535)
u Related topics
• About QC types (515)
• Unloading auto QC racks from the auto QC
compartment (537)
27 Utility menu
Roche Diagnostics
1686 False Bottom Settings window
False Bottom Settings window

f Utility > System > Rack Assignment > False Bottom
> False Bottom Settings
Use this window to define the dimensions of false bottom

tubes/cup on non-standard tubes. The following
dimensions must be defined:
Container Height
Use this text box to enter the length of the tube. Applicable
range: 63.0 mm - 102.0 mm.
u See figure, container height (A)
A Container height C Bottom Level (15 mm

B Rubber holder for the for example)
tube (inside the rack)
Bottom Level Use this text box to enter the distance between the outer
and the inner bottom of the tube. The distance between
the upper edge of the tube and the bottom level must be
27 Utility menu
more than 35.5 mm.

u See figure, bottom level (C)
Conical bottom Select this check box if you use tubes with a conical
bottom.
For exact specifications of the sample containers, please

contact the manufacturer.
Roche Diagnostics
False Bottom Settings window 1687
Special micro cup (only e 801)
If you open the False Bottom Setting window from the False
Bottom 2 tab or the False Bottom 3 tab, the Special micro
cup (only e 801) check box is available.
Select this check box if you use Sarstedt micro tubes.

Select the Sarstedt micro tube that you use from the
following options:
• Cryo Cup 0.5 mL: Sarstedt micro tube 0.5 mL (Mat. No.
72.730)
• Cryo Cup 2.0 mL: Sarstedt micro tube 2.0 mL (Mat. No.
72.664)
Place Sarstedt micro tubes on 13 x 82mm tubes (e.g.,

Sarstedt 60.550). If you use other carriers, you must enter
the Container Height and Bottom Level fields manually.
u List of Sarstedt micro tubes (2035)
27 Utility menu
Roche Diagnostics
1688 Barcode Settings window
Barcode Settings window

f Utility > System > Barcode Settings
This window is used to view and specify barcode settings.
q Before you can change the barcode mode settings, all

samples must be deleted from the Data Review submenu
and the data manager. This prevents the risk of duplicate
sample IDs in the database.
Please also consider to clear the database of the LIS.
Upper area
Routine/STAT Select this check box to enable barcode mode, or clear it

to enable non-barcode mode for routine and STAT
samples.
Calibrator Select this check box to enable barcode mode, or clear it

to enable non-barcode mode for calibrators.
If calibrators are processed without barcode, it is

necessary to assign a rack number and rack position for
each calibrator (Calibration > Calibrators > Rack Assign).
u Assigning non-barcoded calibrators to rack
positions (494)
Control Select this check box to enable barcode mode, or clear it

to enable non-barcode mode for controls.
If controls are processed without barcode, it is necessary

to assign a rack number and rack position for each control
(QC > Controls > Rack Assign).
27 Utility menu

positions (535)
Sample Barcode Check Digit area
This area is used to enable or disable barcode check digits.

Check digits are used to detect barcode read errors. Any
combination of the three barcode checks can be selected.
Code 39 Select this check box to enable, or clear it to disable check

digits for Code 39 type barcodes.
Roche Diagnostics
Barcode Settings window 1689
NW 7 Select this check box to enable, or clear it to disable check

digits for NW 7 type barcodes. When the check box is
selected, a list box appears to the right of the check box.
Select the method of check digit from the list box.
Options include: Modulus 16, Modulus 11, Modulus 10/2

Weight, Modulus 10/3 Weight, 7 Check DR, Weight
Modulus 11 and Modulus 10/2 Weight-A.
ITF Select this check box to enable, or clear it to disable check

digits for ITF type barcodes.
u Related topics
• Specifications of sample barcodes (2039)
27 Utility menu
Roche Diagnostics
1690 Data Manager Settings window
Data Manager Settings window

f Utility > System > Data Manager Settings
This window is used to define all data manager interface

parameters.
It is divided into 3 tabs, which are described in the next

sections.
u For detailed information about the communication
settings, please refer to the Host Interface Manual of
the system.
In this section
Communication Settings tab (1691)
Text Settings tab (1692)
Test Selection Inquiry Settings tab (1693)
27 Utility menu
Roche Diagnostics
Data Manager Settings window 1691
Communication Settings tab

f Utility > System > Data Manager Settings
> Communication Settings
Use this tab to define the communication settings.

u For detailed information about the communication
settings, please refer to the Host Interface Manual of
the system.
System Name Use this text box to define the instrument name (up to
30 characte

Cobas® 8000 Modular Analyzer Series: Complete User Documentation - Version 5.7 Software Version 06-09

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cobas® 8000 modular analyzer

Publication version Software version Revision date Change description

Publication version Software version Revision date Change description

The cobas® 8000 modular analyzer series is composed of

Every effort has been made to ensure that all the

The Safety Guide contains important safety information.

The Operator’s Manual focuses on routine operation and

The Quick Reference Guide provides you with an overview

cobas® e-library provides access to important updates,

A separate Operator’s Manual is available for the

The PC manufacturer’s manual contains all information

The original version of this document is in English. All

Contact your local affiliate or Roche Service

cobas® 8000 modular analyzer series can be used with all

Training Do not carry out operation tasks or maintenance actions

Images The images in this publication have been added exclusively

Warranty Any customer modification to the system renders the

For conditions of warranty, contact your local sales

Always leave software updates to a Roche Service

Copyright © 2007–2022, Roche Diagnostics GmbH.

License information cobas® 8000 modular analyzer series software is

You can redistribute the software and/or modify it under

The software is distributed without warranty. There is no

The source code for the software is stored on the control

This open source and commercial software and

Note that the respective authorization is no longer valid

CPS Security API Copyright © 2017 F. Hoffmann-La Roche Ltd.

The CPS Security API is protected by contract law,

The CPS Security API is licensed for use between

Other product names and trademarks are the property of

CPS Security API might contain components or modules

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, COBAS INTEGRA, and LIFE

All other trademarks are the property of their respective

Approvals The cobas® 8000 modular analyzer series complies with

Directive 98/79/EC of the European Parliament and of the

Regulation (EU) 2017/746 of the European Parliament and

Directive 2011/65/EU of the European Parliament and of

Directive (EU) 2015/863 of 31 March 2015 amending

Directive 2014/53/EU of the European Parliament and of

Regulation (EU) No 517/2014 of the European Parliament

Compliance of specific instruments with the respective

Check the serial number of the instruments to identify the

Fluorinated greenhouse gases specifications can be found

All documents are available under eLabDoc on the Roche

If you are unable to access Roche DiaLog, contact your

Compliance is provided by means of the Declaration of

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

Issued by Intertek for Canada and the US.

Instrument approvals Furthermore, the instrument is manufactured and tested

The instrument complies with the emission and immunity

Inside the European Union and

Manufacturer of the Hitachi High-Tech Corporation

Authorized Roche Diagnostics GmbH

Outside the European Union and

Manufactured by: Hitachi High-Tech Corporation

Manufactured for: Roche Diagnostics GmbH