Cobas E411 ServiceManual v1.0

Roche Diagnostics / Hitachi
cobas e 411
Service Manual Version 1.0

May 2006
Service Manual
for
cobas e411
Immunoassay
System
Revision Record
Date Number Version New Chapter
January 2006 Draft

May 2006 1.0
Note
Part No. and Part name are different depending on the manufacturing time.
Please refer to Parts List for details.
RD/Hitachi Immunoassay System cobas e411 Service
Manual
1. Application/Introduction
1.1 Instrument
1.2 Specifications
1.3 Operating Precautions and Hazards
1.4 Service Concept
1.5 Rack Sampler/Rack Conveyor System
2. Installation / Set Up
2.1 Site Requirements
2.2 Inventory
2.3 Analyzer Installation
2.4 Software Installation
2.5 Rack Sampler Connected to CLAS 1 System Installation
2.6 Check/Adjustment During Installation
3. Fludics
3.1 Description of Flow Path
3.2 System Volume
3.3 Cleaning Procedures
3.4 SysWash
4. Mechanics
4.1 Overview
4.2 Location of Mechanisms
4.3 List of Motors, Sensors and Other Mechanisms
4.4 Detailed Explanation of Each Mechanism
4.5 Mechanical Adjustment
4.6 Rack Sampler System
5. Electronics
5.1 Boards
5.2 Power Source
5.3 Electronic Modules
5.4 Printed Circuit Boards
5.5 Cross Wiring Diagrams
5.6 How to Check Photo Interrupters
6. Service Software
6.1 Overview
1
7. Troubleshooting
7.1. Alarms List
7.2 Data Alarms
7.3 Troubleshooting List
7.4 Data File Load Errors
7.5 Quality Control Check
8. Spare Parts/Recommended Parts

8.1 Special Service Tools
8.2 Complete Recommended Parts List
8.3 Printed Circuit Boards List
9. Host Interface (not applicable)
10. Maintenance
10.1 Operator Maintenance
10.2 Preventive Maintenance
10.3 Maintenance Material
Appendix
Timing Chart Tables
Assay Timetable
2
System Description
Chapter 1 System Description
1.1 INSTRUMENT ..............................................................................................................................................1 - 1

1.1.1 System Configuration ........................................................................................................................ 1 - 1
1.1.2 System Introduction........................................................................................................................... 1 - 2
1.1.3 Control Unit Components ................................................................................................................. 1 - 5
1.1.4 Sample/Reagent Area Components ................................................................................................... 1 - 7
1.1.5 Consumables Area Components...................................................................................................... 1 - 22
1.1.6 Measuring Area Components.......................................................................................................... 1 - 27
1.1.7 Power Components ......................................................................................................................... 1 - 33
1.1.8 Mechanical Theory.......................................................................................................................... 1 - 35
1.1.9 Detailed Assay Sequence................................................................................................................. 1 - 38
1.1.10 Dilution Steps ................................................................................................................................ 1 - 47
1.1.11 Analyzer Status Conditions ........................................................................................................... 1 - 48
1.2 TECHNICAL DATA ....................................................................................................................................1 - 52
1.2.1 Technical Data for Operation of Instrument................................................................................... 1 - 52
1.3 POTENTIAL HAZARD AND SAFETY PRECAUTIONS ....................................................................................1 - 61
1.3.1 Safety Classifications ...................................................................................................................... 1 - 61
1.3.2 Safety Information........................................................................................................................... 1 - 62
1.3.3 Safety Labels on the cobas e411...................................................................................................... 1 - 68
1.3.4 Approvals ........................................................................................................................................ 1 - 70
1.4 SYSTEM LABEL ........................................................................................................................................1 - 71
1.4.1 Disk System ..................................................................................................................................... 1 - 71
1.4.2 Rack System..................................................................................................................................... 1 - 73
Contents - 1
Installation / Set Up
Chapter 2 Installation / Set Up
2.1 SITE REQUIREMENTS ..................................................................................................................................2 - 1

2.1.1 Delivery Space Requirements............................................................................................................ 2 - 1
2.1.2 Physical Space and weighs Requirements......................................................................................... 2 - 1
2.1.3 Ambient Condition Requirements...................................................................................................... 2 - 3
2.1.4 Electrical Requirements .................................................................................................................... 2 - 3
2.1.5 Water Requirements .......................................................................................................................... 2 - 3
2.2 INVENTORY ................................................................................................................................................2 - 4
2.3 ANALYZER INSTALLATION .........................................................................................................................2 - 7
2.3.1 Unpacking ......................................................................................................................................... 2 - 7
2.3.2 Explanation of Packaging Position in the System ........................................................................... 2 - 14
2.3.3 Panel PC Installation and confirmation of AC Power Supply ........................................................ 2 - 21
2.3.4 Setup................................................................................................................................................ 2 - 25
2.3.5 Mounting a Measuring Cell ............................................................................................................ 2 - 25
2.3.6 Installation of System Software ....................................................................................................... 2 - 26
2.3.7 Fill Liquid System ........................................................................................................................... 2 - 26
2.3.8 Adjustments to be Checked During Installation and After Replacement......................................... 2 - 26
2.3.9 Measuring Cell Preparation ........................................................................................................... 2 - 27
2.3.10 System Volume Check.................................................................................................................... 2 - 28
2.3.11 High Voltage Check/Adjustment ................................................................................................... 2 - 28
2.3.12 Initial BlankCell Calibrations ....................................................................................................... 2 - 35
2.3.13 Instrument Checks......................................................................................................................... 2 - 39
2.3.14 Assay Calibration.......................................................................................................................... 2 - 51
2.3.15 Installation Procedures Overview / Checklist ............................................................................... 2 - 51
2.3.16 Procedure for Multiple Installations............................................................................................. 2 - 51
2.4 SOFTWARE INSTALLATION .......................................................................................................................2 - 53
2.4.1 Application Instruction.................................................................................................................... 2 - 53
2.4.2 Printer Driver Instruction ............................................................................................................... 2 - 58
2.4.3 System Parameter Setup.................................................................................................................. 2 - 69
2.5 RACK SAMPLER SYSTEM INSTALLATION..................................................................................................2 - 70
2.5.1 Rack Sampler System Installation ................................................................................................... 2 - 70
2.6 CHECKS/ADJUSTMENTS DURING INSTALLATION .....................................................................................2 - 84
2.6.1 Bead Mixer ...................................................................................................................................... 2 - 84
2.6.2 Pipetter Adjustment......................................................................................................................... 2 - 86
2.6.3 Sipper adjustment............................................................................................................................ 2 - 86
2.6.4 Electronic adjustments .................................................................................................................... 2 - 86
2.6.5 Rack Sampler adjustments .............................................................................................................. 2 - 86
2.7 TABLE OF CONTENTS ...............................................................................................................................2 - 92
2.7.1 Method to detach the external covers.............................................................................................. 2 - 92
2.7.2 Method to attach the external covers .............................................................................................. 2 - 99
2.7.3 Mmethod to detach the PC Unit .................................................................................................... 2 - 107
2.7.4 Method to attach the PC Unit ....................................................................................................... 2 - 109
Contents - 1
Fluidics
Chapter 3 Fluidics
3.1 DESCRIPTION OF FLOW PATH .....................................................................................................................3 - 1

3.1.1 Overall Piping Diagram.................................................................................................................... 3 - 2
3.1.2 List of Parts ....................................................................................................................................... 3 - 3
3.2 SYSTEM VOLUME .......................................................................................................................................3 - 3
3.2.1 Definition of System Volume ............................................................................................................. 3 - 3
3.2.2 Determination of System Volume ...................................................................................................... 3 - 3
3.2.3 Storage of the System Volume Value / Data Handling...................................................................... 3 - 4
3.3 CLEANING PROCEDURES ............................................................................................................................3 - 5
3.3.1 Liquid Flow Cleaning ....................................................................................................................... 3 - 5
3.3.2 Cleaning Procedure for Fluidics System........................................................................................... 3 - 6
3.4 SYSWASH ..................................................................................................................................................3 - 8
3.4.1 Introduction....................................................................................................................................... 3 - 8
3.4.2 SysWash Rinsing Procedure.............................................................................................................. 3 - 8
Contents - 1
Mechanics
Chapter 4 Mechanics
4.1 OVERVIEW .................................................................................................................................................4 - 1

4.1.1 Location ............................................................................................................................................ 4 - 1
4.1.2 Outline of Mechanical Units ............................................................................................................. 4 - 1
4.2 LOCATION OF MECHANISMS ......................................................................................................................4 - 3
4.2.1 Analyzer ............................................................................................................................................ 4 - 3
4.2.2 Rack Sampler System ........................................................................................................................ 4 - 6
4.3 LIST OF MOTORS, SENSORS, AND OTHER MECHANISMS ..........................................................................4 - 10
4.3.1 List of Motors .................................................................................................................................. 4 - 10
4.3.2 Motor Reference List....................................................................................................................... 4 - 10
4.3.3 List of Sensors ................................................................................................................................. 4 - 10
4.3.4 List of Peltier, Heater and Fan Motor ............................................................................................ 4 - 11
4.3.5 List of Motors for Rack Sampler System ......................................................................................... 4 - 12
4.3.6 List of Sensors for Rack Sampler System ........................................................................................ 4 - 12
4.3.7 List of LEDs and Fan Motor for Rack Sampler System .................................................................. 4 - 12
4.4 DETAILED EXPLANATION OF EACH MECHANISM .....................................................................................4 - 13
4.4.1 Sample Disk Drive Mechanism ....................................................................................................... 4 - 13
4.4.2 Reagent Disk Drive Mechanism ...................................................................................................... 4 - 19
4.4.3 Cap Open/Close Mechanism........................................................................................................... 4 - 28
4.4.4 Beads Mixer Mechanism ................................................................................................................. 4 - 33
4.4.5 Pipetter Mechanism ........................................................................................................................ 4 - 40
4.4.6 Gripper Mechanism ........................................................................................................................ 4 - 52
4.4.7 Sipper Mechanism........................................................................................................................... 4 - 66
4.4.8 System Reagent Mechanism ............................................................................................................ 4 - 74
4.4.9 Syringe Mechanism ......................................................................................................................... 4 - 77
4.4.10 System Water Container (Float SW) Mechanism / Pump Assembly.............................................. 4 - 81
4.4.11 Liquid Waste Container Mechanism ............................................................................................. 4 - 87
4.4.12 Solid Waste Mechanism ................................................................................................................ 4 - 91
4.4.13 Detection Unit ............................................................................................................................... 4 - 94
4.4.14 Magnet Drive Mechanism ........................................................................................................... 4 - 105
4.4.15 Matrix BCR Mechanism .............................................................................................................. 4 - 110
4.4.16 SIPPER SAFETY COVER (INTER ROCK Mechanism).............................................................. 4 - 121
4.5 MECHANICAL ADJUSTMENT ...................................................................................................................4 - 123
4.5.1 Overview ....................................................................................................................................... 4 - 123
4.5.2 Mechanical Adjustment Procedure ............................................................................................... 4 - 123
4.5.3 Mechanical Adjustment Procedure for Rack Sampler .................................................................. 4 - 129
4.6 RACK SAMPLER SYSTEM ........................................................................................................................4 - 132
4.6.1 Overview ....................................................................................................................................... 4 - 132
4.6.2 Rack Sampler Movement............................................................................................................... 4 - 132
4.6.3 A Line ............................................................................................................................................ 4 - 133
4.6.4 B Line ............................................................................................................................................ 4 - 134
4.6.5 C Line............................................................................................................................................ 4 - 137
Contents - 1
Electronics
Chapter 5 Electronics
5.1 BOARDS .....................................................................................................................................................5 - 1

5.1.1 System Overview ............................................................................................................................... 5 - 1
5.1.2 Location of Boards............................................................................................................................ 5 - 2
5.2 POWER SOURCE .......................................................................................................................................5 - 10
5.2.1 AC Power ........................................................................................................................................ 5 - 10
5.2.2 DC Power Supply............................................................................................................................ 5 - 11
5.3 ELECTRONIC MODULES / ELECTRONIC ADJUSTMENTS .............................................................................5 - 17
5.3.1 Principle of Temperature Control................................................................................................... 5 - 17
5.3.2 Principle of LLD ............................................................................................................................. 5 - 18
5.3.3 Principle of Clot Detection ............................................................................................................. 5 - 20
5.3.4 Adjustment / Check Procedure of LLD/Clot Detection ................................................................... 5 - 20
5.3.5 Functional Details of FRONT SW (Operation Switch) ................................................................... 5 - 27
5.3.6 Details of Temperature Control / Troubleshooting of Temp. Units ................................................ 5 - 28
5.3.7 Serial Data Communication............................................................................................................ 5 - 31
5.3.8 Adjustment of Mixer Speed.............................................................................................................. 5 - 32
5.4 PRINTED CIRCUIT BOARDS .......................................................................................................................5 - 33
5.4.1 ECPU550 Board ............................................................................................................................. 5 - 33
5.4.2 EECL300 Board .............................................................................................................................. 5 - 36
5.4.3 EMOT300 Board............................................................................................................................. 5 - 38
5.4.4 EIO3 Board ..................................................................................................................................... 5 - 42
5.4.5 DO1 Board...................................................................................................................................... 5 - 44
5.4.6 DO2 Board...................................................................................................................................... 5 - 47
5.4.7 DO3 Board...................................................................................................................................... 5 - 48
5.4.8 DIST-PA Board ............................................................................................................................... 5 - 50
5.4.9 DIST-SA Board................................................................................................................................ 5 - 51
5.4.10 DIST-TVA Board........................................................................................................................... 5 - 52
5.4.11 DIST-F Board................................................................................................................................ 5 - 52
5.4.12 DIST-F3 Board.............................................................................................................................. 5 - 54
5.4.13 DIST232C Board........................................................................................................................... 5 - 55
5.4.14 ANG-EP2 Board............................................................................................................................ 5 - 56
5.4.15 PMT-SHV2 Board ......................................................................................................................... 5 - 59
5.4.16 L-AMP(3) Board ........................................................................................................................... 5 - 60
5.4.17 LLD-SA Board............................................................................................................................... 5 - 62
5.4.18 LLD-P3 Board............................................................................................................................... 5 - 63
5.4.19 UIRS-C Board ............................................................................................................................... 5 - 64
5.4.20 MVLB110 Board ........................................................................................................................... 5 - 65
5.4.21 S.AB-CE Board ............................................................................................................................. 5 - 66
5.4.22 DET-A Board ................................................................................................................................ 5 - 67
5.4.23 DET-B Board ................................................................................................................................ 5 - 68
5.4.24 DET-C Board ................................................................................................................................ 5 - 68
5.4.25 DETECT1 Board........................................................................................................................... 5 - 69
5.4.26 RS CONTD Doard......................................................................................................................... 5 - 69
5.4.27 PS CONTA Board ......................................................................................................................... 5 - 71
5.4.28 DO4A Board ................................................................................................................................. 5 - 73
5.4.29 BCR Board .................................................................................................................................... 5 - 75
5.4.30 PH-D Board .................................................................................................................................. 5 - 76
5.4.31 PH-T Board................................................................................................................................... 5 - 76
5.5 CROSS WIRING DIAGRAMS ......................................................................................................................5 - 77
5.5.1 Cross Wiring Diagrams for Rack Sampler System.......................................................................... 5 - 77
5.5.2 Cross Wiring Diagrams for Rack Sampler...................................................................................... 5 - 77
5.6 HOW TO CHECK PHOTO INTERRUPTERS ...................................................................................................5 - 78
5.6.1 Photo Interrupters........................................................................................................................... 5 - 78
5.6.2 How to check the PCPs ................................................................................................................... 5 - 80
Contents - 1
Service Software
Chapter 6 Service Software
6.1 OVERVIEW .................................................................................................................................................6 - 1

6.1.1 Utility Screen of Print ....................................................................................................................... 6 - 4
6.1.2 Interface Setup ................................................................................................................................ 6 - 10
6.1.3 System Setup.................................................................................................................................... 6 - 13
6.1.4 Storage Utility ................................................................................................................................. 6 - 15
6.1.5 Documentation and Printer Setting................................................................................................. 6 - 18
6.1.6 Keep Function Setup ....................................................................................................................... 6 - 20
6.1.7 Retry Function Setup....................................................................................................................... 6 - 20
6.1.8 Sample Reception Mode .................................................................................................................. 6 - 21
6.2 MAINTENANCE .........................................................................................................................................6 - 22
6.2.1 Detailed Description of Each Maintenance Function..................................................................... 6 - 24
6.3 MECHANISM CHECK ................................................................................................................................6 - 27
6.3.1 System Volume Check...................................................................................................................... 6 - 31
6.3.2 Assay Performance Check............................................................................................................... 6 - 31
6.3.3 Voltage Monitor .............................................................................................................................. 6 - 39
6.3.4 Temperature Monitor ...................................................................................................................... 6 - 40
6.3.5 Sensor Monitor................................................................................................................................ 6 - 41
6.4 SERVICE ...................................................................................................................................................6 - 43
6.4.1 Manual Adjustment ......................................................................................................................... 6 - 44
6.4.2 Adjustment Rack.............................................................................................................................. 6 - 47
6.4.3 BCR Setup ....................................................................................................................................... 6 - 49
6.4.4 Service Setup ................................................................................................................................... 6 - 52
6.4.5 Service Maintenance ....................................................................................................................... 6 - 53
6.4.6 Alarm Setting................................................................................................................................... 6 - 55
6.4.7 Initial Blank Cell ............................................................................................................................. 6 - 56
6.4.8 Automatic Adjustment ..................................................................................................................... 6 - 59
Contents - 1
Troubleshooting
Chapter 7 Troubleshooting
7.1 ALARM LIST ...............................................................................................................................................7 - 1

7.2 DATA ALARM LIST ....................................................................................................................................7 - 2
7.3 TROUBLESHOOTING LIST ............................................................................................................................7 - 4
7.3.1 Reagent Disk ..................................................................................................................................... 7 - 4
7.3.2 Cap Opener ....................................................................................................................................... 7 - 5
7.3.3 Beads Mixer ...................................................................................................................................... 7 - 6
7.3.4 Barcode Reader Mechanism ............................................................................................................. 7 - 8
7.3.5 Sample Disk Mechanism ................................................................................................................... 7 - 8
7.3.6 Pipetter Mechanism .......................................................................................................................... 7 - 9
7.3.7 Pipetter / Sipper Syringe ................................................................................................................. 7 - 11
7.3.9 Solid Waste...................................................................................................................................... 7 - 15
7.3.10 Sipper Mechanism......................................................................................................................... 7 - 16
7.3.11 Magnet Drive Mechanism ............................................................................................................. 7 - 17
7.3.12 Pipetter Buffer............................................................................................................................... 7 - 18
7.3.13 Distilled Water Float Switch ......................................................................................................... 7 - 18
7.3.14 System Reagent Unit ..................................................................................................................... 7 - 19
7.3.15 Liquid Waste Mechanism .............................................................................................................. 7 - 19
7.3.16 Rack Sampler System .................................................................................................................... 7 - 21
7.3.17 CF card problem ........................................................................................................................... 7 - 22
7.4 QUALITY CONTROL CHECK......................................................................................................................7 - 26
7.4.1 Covers ............................................................................................................................................. 7 - 26
7.4.2 Sample/Assay Reagent Rotation Mechanism................................................................................... 7 - 26
7.4.3 Cap Open/Close Mechanism........................................................................................................... 7 - 26
7.4.4 Beads Mixer Mechanism ................................................................................................................. 7 - 26
7.4.5 Barcode Reader Mechanism ........................................................................................................... 7 - 26
7.4.6 Pipetter, Sipper Mechanism ............................................................................................................ 7 - 27
7.4.7 Syringes Mechanism (after exchange); ........................................................................................... 7 - 27
7.4.9 solid Waste Mechanism................................................................................................................... 7 - 27
7.4.10 1Incubation Unit ........................................................................................................................... 7 - 27
7.4.11 1Detection Unit ............................................................................................................................. 7 - 28
7.4.12 1Pump Module (after exchange);.................................................................................................. 7 - 28
Contents - 1
Spare Parts/Recommended Parts
Chapter 8 Spare Parts/Recommended Parts
8.1 SPECIAL SERVICE TOOLS ...........................................................................................................................8 - 1

8.2 COMPLETE PARTS LIST ..............................................................................................................................8 - 2
Contents - 1
Host Interface
Chapter 9 Host Interface
9.1 HOST INTERFACE .......................................................................................................................................9 - 1
Contents - 1
Maintenance
Chapter 10 Maintenance
10.1 MAINTENANCE PROCEDURE OVERVIEW ................................................................................................10 - 6

10.1.1 Replace pipettor tube 510 ............................................................................................................. 10 - 8
10.1.2 Replace pipettor tube 465 with nozzle seal ................................................................................. 10 - 10
10.1.3 Replace Pinch Valve Tubing ....................................................................................................... 10 - 13
10.1.4 Replace Pipettor Seals ................................................................................................................ 10 - 15
10.1.5 Exchange packings for sipper & pipettor syringe ....................................................................... 10 - 22
10.1.6 Clean Rinse Stations for S/R Probe, Mixer and Sipper Probe .................................................... 10 - 24
10.1.7 Clean Sipper and S/R probe ........................................................................................................ 10 - 26
10.1.8 Clean water filter main pump...................................................................................................... 10 - 29
10.1.9 Clean System Water Container ................................................................................................... 10 - 31
10.1.10 Clean Liquid Waste Container .................................................................................................. 10 - 33
10.1.11 Clean ProCell/CleanCell Compartments .................................................................................. 10 - 34
10.1.12 Clean Reagent Disk and Compartment ..................................................................................... 10 - 35
10.1.13 Check drain tubes for contamination and exchange if necessary ............................................. 10 - 37
10.1.14 Drain the outlet pipettor wash station and waste pipe.............................................................. 10 - 39
10.1.15 Perform Liquid Flow Cleaning ................................................................................................. 10 - 39
10.1.16 Perform system volume check ................................................................................................... 10 - 41
10.1.17 Exchange mixer belt S ............................................................................................................... 10 - 41
10.1.18 Clean mixer paddle ................................................................................................................... 10 - 42
10.1.19 Check mixer speed; adjust if necessary..................................................................................... 10 - 43
10.1.20 Check / Clean gripper finger..................................................................................................... 10 - 44
10.1.21 Clean light barriers and mechanic parts................................................................................... 10 - 45
10.1.22 Clean Incubator and Aspiration Station.................................................................................... 10 - 45
10.1.23 Check LLD voltage pipettor ...................................................................................................... 10 - 47
10.1.24 Check LLD voltage sipper......................................................................................................... 10 - 47
10.1.25 Check clot voltage ..................................................................................................................... 10 - 47
10.1.26 Check Temperature Monitor for Detection unit ........................................................................ 10 - 47
10.1.27 Check Temperature Monitor for Incubator............................................................................... 10 - 47
10.1.28 Check Temperature Monitor for Reagent.................................................................................. 10 - 47
10.1.29 Check Temperature Monitor for PC / CC ................................................................................. 10 - 47
10.1.30 Clean peltier elements from dust if necessary ........................................................................... 10 - 47
10.1.31 Clean BCR window and window reagent disk .......................................................................... 10 - 49
10.1.32 Perform artificial media check.................................................................................................. 10 - 50
10.1.33 Perform TSH assay test ............................................................................................................. 10 - 50
10.1.34 Perform initial blank cell .......................................................................................................... 10 - 50
10.1.35 Perform assay calibration......................................................................................................... 10 - 50
10.1.36 Perform assay control ............................................................................................................... 10 - 50
10.1.37 Exchange measuring cell .......................................................................................................... 10 - 51
10.1.38 Exchange tube B for MC ........................................................................................................... 10 - 52
10.1.39 Exchange tube B for sipper with nozzle seal ............................................................................. 10 - 54
10.1.40 Exchange tube B for sipper syringe .......................................................................................... 10 - 56
10.1.41 Clean the valve body on the system water container................................................................. 10 - 58
10.1.42 Exchange O-ring SV 1 / 2 / 5 / 6 / 7 .......................................................................................... 10 - 59
10.1.43 Exchange sipper wash station ................................................................................................... 10 - 61
10.1.44 Exchange the spring at the gripper finger................................................................................. 10 - 64
10.2 OPERATOR MAINTENANCE...................................................................................................................10 - 66
10.3 MAINTENANCE MATERIALS .................................................................................................................10 - 67
Contents - 1
RD/Hitachi cobas e411 Service Manual
1.1 Instrument
1.1.1 System Configuration
Figure 1.1-1 cobas e411 disk system
Figure 1.1-2 cobas e411 rack system
Version 1.0 – May 2006 1-1 Chapter 1.1

1.1.2 System Introduction

The Roche Diagnostics cobas e411 Immunoassay System is a fully automated, software-controlled
system for immunoassay analysis. It is designed for both quantitative and qualitative in vitro
determinations using a large variety of tests for analysis.
To assist you in quickly identifying which component is specific to either the disk or rack system, one
of the following graphics appears to the right of the subsection header. If no graphic appears next to
the header, then that component is common to both systems.
Figure 1.1-3 Disk
Figure 1.1-4 Rack
1.1.2.1 The Control Unit

The control unit of the e411 analyzer is a touchscreen, no-keyboard type computer, which is located
on the left-center of the analyzer unit. This monitor unit contains the controlling software and also has
an on-screen keyboard function.
Figure 1.1-5 Control unit

1.1.2.2 The Analyzer Unit
Figure 1.1-6
The analyzer unit on the disk system consists of the:

• sample/reagent area
• consumables area
• measuring area
• operation switch
The only difference on the rack system is in the sample area. The sample disk is replaced by a rack
sampling unit.
Refer to the photo below.
Figure 1.1-7

1.1.2.3 Sample/Reagent Area

The sample/reagent area comprises the left half of the analyzer and consists of a sample disk or rack
sampler (rack system), rack bar code reader (rack system), sample/reagent (S/R) probe, bar code
reader, bar code card reading station, reagent disk, a cap open/close mechanism, a microparticle
mixer, probe/ mixer rinse station and sample/reagent (S/R) pipettor.
The sample disk accommodates up to 30 samples. The A-Line of the rack sampler accommodates 75
samples on a single tray (15 racks at a time; each rack with five positions) and 25 samples in the input
buffer for a total capacity of 100 samples. The reagent disk, temperature controlled at 20 ± 3 °C,
accommodates up to 18 reagent packs.
1.1.2.4 Consumables Area

The consumables area is on the right of the analyzer, consisting of three tip trays, three AssayCup
trays, a gripper unit, cup disposal opening, liquid waste container, solid waste tray and liner and
system water container.
1.1.2.5 Measuring Area

The measuring area includes the incubator, the sipper probe, sipper rinse station, system reagents
(ProCell and CleanCell), an aspiration station, sipper pipettor and the detection unit. The sipper probe
aspirates the incubated reaction mixture into the detection unit for result determination.
1.1.2.6 Operation Switch

The operation ON/OFF switch is located on the front left of the analyzer. In addition, there is a circuit
breaker for the analyzer located on the right side panel and a rack sampler circuit breaker located on
the left side of the rack sampler.

1.1.3 Control Unit Components

The control unit consists of a color touchscreen monitor, host interface and external printer.
1.1.3.1 Touchscreen Monitor

The touchscreen monitor is located on the left-center of the analyzer and displays the software. For
details on the cobas e411 software, refer to the Software Guide.
Figure 1.1-8 Touchscreen monitor

1.1.3.2 On-screen Keyboard

The e411 software has an on-screen keyboard. For details refer to the Software Guide.
Figure 1.1-9 On-screen keyboard
1.1.3.3 External Printer

The instrument uses an 80-column, graphics-capable, dot matrix printer.
The printer is connected to the analyzer via a USB port. The analyzer has two USB ports on its left
side.
Figure 1.1-10 Location of the USB ports and Host port
1.1.3.4 Host Interface

The instrument can be bidirectionally interfaced with a host computer.
Please refer the Host Interface manual in detail.

1.1.4 Sample/Reagent Area Components

The sample/reagent area consists of a sample disk or rack sampler (rack system), rack ID bar code
reader (rack system), sample/reagent (S/R) probe, bar code reader, bar code card reading station,
reagent disk, cap open/close mechanism, microparticle mixer, probe/mixer rinse station and
sample/reagent (S/R) pipettor.
Figure 1.1-11 Sample Disk
The sample disk has 30 positions for samples, calibrators and controls. Patient samples may be
placed in either primary sample tubes or sample cups. Built-in adapters allow intermixing of different
size primary sample tubes.
Sample tubes that may be used are listed in chapter 2.7 Technical Data.
Sample cups [2 mL (Standard) Hitachi cups only] may be placed directly on the sample disk or on top
of 16 mm primary sample tubes.
Figure 1.1-12 Sample disk
CAUTION
Micro cups cannot be used on the
e411 analyzer!

Note: How to raise the sample disk protective cover

To take out the sample disk, first you must raise the sample disk protective cover. The cover can be
held at a certain angle. To lay the cover down, release the hold by raising the cover up to its limit
angle. Be sure to lay it down before you start operation.
Figure 1.1-13 Sample disk protective cover
Figure 1.1-14 n Raising the sample disk protective cover

Figure 1.1-15 Standing angle
Figure 1.1-16 Limit angle
CAUTION
Be sure to lay down the sample disk
protective cover before you start
operation.

Figure 1.1-17
Rack Sampler
The rack sampler consists of an A-Line, B-Line, C-Line and STAT position.
1.1.4.1 A-Line
Specimens are placed in 5-position sample racks and are loaded onto a tray. Once a tray is loaded,
additional racks can be added to the tray one at a time during Operation, provided the tray indication
light is green (ON). If the light is out (OFF), the pusher arm is preparing to move. The pusher arm is
located at the far left of the A-Line and pushes the sample racks forward and onto the B-Line.
The A-Line holds a tray that accommodates 15 racks at one time. Another five racks can be in the
input buffer. Therefore, you can have a total of 100 specimens loaded at any one time. Refer to the
photo and graphic below.
Figure 1.1-18
Version 1.0 – May 2006 1 - 10 Chapter 1.1

Figure 1.1-19
1.1.4.2 B-Line
The B-Line transports the sample racks, single file, first to the rack bar code reader. Here each
position in the rack is scanned for a sample bar code. After the last position is scanned, the bar code
reader scans the rack ID. After the last specimen is sampled, the rack is transferred via the output
buffer onto the tray on the C-Line. Refer to the photo and graphic below.
Figure 1.1-20

Figure 1.1-21 B-Line of the rack sampler
1.1.4.3 Rack Bar Code Reader

The rack bar code reader reads both sample bar code labels and the rack bar code label. The bar
code reader is auto-discriminating, allowing the use of various types of bar codes during operation.
Bar code symbologies read include:
• NW7 (Codabar)
• Code 39
• Code 128
• Interleaved 2 of 5
Figure 1.1-22 Rack bar code reader

1.1.4.4 C-Line
Racks are off-loaded from the B-Line into the output buffer. If there is no tray, up to 5 racks can enter
the output buffer, thereafter the sampling procedure is stopped. When the sixth rack is moved into the
output buffer, a rack is pushed onto the tray on the C-Line. You can remove the tray from the C-Line
any time the tray indication light is green (ON). If the light is out (OFF), the system is preparing to push
a rack onto the C-Line tray. You cannot remove single racks from the C-Line. You must remove an
entire tray at one time.
Figure 1.1-23
Figure 1.1-24 C-Line of the rack sampler
If the tray is removed, the system continues to push racks into the output buffer. If the buffer fills and
there is no tray, the analyzer issues an alarm and stops sampling racks.

Figure 1.1-25 Output buffer with racks
1.1.4.5 STAT Position

The STAT position is located at the front of the analyzer and is in line to feed directly onto the B-Line.
Place a rack in the position as directed on the label and press the STAT key. When the rack currently
being sampled is completed, the STAT rack is pushed onto the B-Line and is sent on to the rack bar
code reader and sampling position.
Figure 1.1-26

Figure 1.1-27 STAT position of the rack sampler
1.1.4.6 Sample Rack

Sample cups, primary sample tubes, calibrator or control vials are placed in sample racks shown
below. Each sample rack holds a maximum of five samples. Each tube slot contains adapters that
allow the rack to hold different sizes of primary sample tubes. Each rack has a unique ID found on the
bar code label on the back end of the rack. This rack ID is read by the bar code reader and transferred
to the system. This ID appears on the screens in the software and on the reports.
Figure 1.1-28 Sample rack
1.1.4.7 Sample/Reagent (S/R) Probe

The sample/reagent probe is located on the back left wall of the analyzer and is mounted on an arm
(S/R arm) that moves horizontally between the sample and reagent disk. The probe uses disposable
tips to avoid sample carryover, and has liquid level and clot detection for accurate pipetting. Liquid
level detection is accomplished by capacitance measurement. Clot detection is accomplished by a
pressure transducer.
A new AssayTip is utilized with every new pipetting sequence. For example, TSH = 1 tip for R1, R2
and sample, then one new tip for microparticles. The tip is washed externally at the rinse station
between each aspiration. Additional tips are used for sample dilutions or pretreatment.

Figure 1.1-29 S/R probe with tip
Note: Ensure that there is no foam on the surface of the sample.

1.1.4.8 Bar Code Reader

During a sample scan, the bar code reader scans the information on the bar code-labeled primary
sample tubes, calibrators or controls, and transmits it to the software. During a reagent scan, the
reader rotates to the reagent disk side to read the 2-dimensional bar code labels on the reagent packs.
The bar code reader is located toward the back wall of the analyzer.
Figure 1.1-30 On the disk system:
• it can be seen when either the sample disk or reagent disk is removed.
• to read bar code labels, the bar code reader rotates between the sample and reagent disks, and
the card reading station.
Figure 1.1-31
On the rack system:
• it can only be seen when the reagent disk is removed.

• to read bar code labels, the bar code reader rotates between the reagent disk and the card
reading station.
• A second bar code reader scans sample bar codes and rack ID bar codes.
The bar code reader is auto-discriminating, allowing the use of various types of bar codes during
operation. In addition, this bar code reader also reads PDF417.
Note: PDF417 can only be used for reagent bar codes and bar code cards.
Figure 1.1-32 Bar code reader (sample disk side)

Figure 1.1-33 Bar code reader (reagent disk side)
1.1.4.9 Bar Code Card Reading Station

At this station, the bar code reader scans calibrator and control information from the calibrator or
control bar code card. These cards are packed in calibrator or control kits.
Figure 1.1-34
On the disk system:
• it is located between the sample disk and reagent disk.
Figure 1.1-35
On the rack system:
• it is located to the back left of the reagent disk.
Figure 1.1-36 Bar code card reading station

1.1.4.10 Reagent Disk

The reagent disk contains 18 positions for assays, diluent or pretreatment reagent. These 18 positions
can be used in any combination, with the following restrictions: max. 18 assays, max. 8 diluents, max.
9 pretreatments.
The reagent disk is temperature controlled at 20 ± 3 °C.
Note: Diluents or pretreatment reagents can be placed in ANY position on the reagent disk. More
than one reagent pack can be loaded on the reagent disk for each test.
Figure 1.1-37 Reagent disk
1.1.4.11 Reagent Cap Open/Close Mechanism

To prevent reagents from evaporating, and to promote ease of use for the operator, the reagent disk
utilizes a reagent cap open/close mechanism during reagent pipetting. The mechanism is located on
the back wall of the reagent disk compartment and emerges when reagents need to be opened or
closed. Caps are opened prior to pipetting or mixing the specific reagent (e.g., M, R1 or R2) and are
closed when pipetting or mixing for the specific reagent (e.g., M, R1 or R2) is completed.
Figure 1.1-38 Reagent cap open/close mechanism

1.1.4.12 Microparticle Mixer

The mixer is utilized to mix the microparticles to ensure a homogeneous suspension before aspiration.
The mixer is located to the right of the reagent disk. In its home position, it occupies the space directly
to the left of the S/R probe.
Figure 1.1-39 Microparticle mixer
1.1.4.13 Probe/Mixer Rinse Station

The rinse station rinses the AssayTip or mixer externally with system water between aspirations, or
before and after microparticle mixing. The rinse station is located below the S/R probe and mixer
when the probe is in its Stand-by position and the mixer is in its home position.
Figure 1.1-40 Rinse station

1.1.4.14 Sample/Reagent (S/R) Pipettor

The S/R pipettor is located on the back right of the analyzer. The pipettor is filled with system water
and uses positive displacement to aspirate and dispense from the S/R probe.
Figure 1.1-41 Sample/reagent pipettor

1.1.5 Consumables Area Components

The consumables area consists of three AssayCup trays, three tip trays, gripper, incubator, cup
disposal opening, pipetting station, liquid waste container, system water container and solid waste tray
and liner.
One tip tray holds up to 120 tips, and one cup tray holds up to 60 cups. Therefore, a total of 360 tips
and 180 cups can be placed on the analyzer.
Figure 1.1-42 Tip tray and cup tray

1.1.5.1 Gripper
The gripper can move in three directions:
• X (left and right)
• Y (forward and back)
• Z (up and down)
It is also equipped with gripping fingers for gripping a tip or AssayCup. The gripping fingers grip a tip
from the tip tray, or a cup from the cup tray and deliver it to the pipetting station. Then, at the
appropriate time, the gripper moves the AssayCup to the incubator, then to the aspiration station, and
finally to the cup disposal opening.
During operation, the analyzer starts utilizing tips and cups from tray 1, position 1. As soon as tray 1 is
empty, the analyzer starts using tray 2. As soon as tray 2 is empty, the analyzer continues with tray 3.
When tray 3 is empty, the analyzer returns to tray 1, if a new tray has been reloaded.
Figure 1.1-43 Gripper and trays
1.1.5.2 Cup Disposal Opening

AssayCups are discarded through a cup opening located directly to the left of the incubator.
Figure 1.1-44 Cup disposal opening

1.1.5.3 Pipetting Station

A five position pipetting station is located to the upper left of the incubator. AssayCups and tips are
moved by the gripper to this location for sample and reagent pipetting, sample dilution and sample
pretreatment. The AssayTips are discarded at the tip eject station at the far right of the station.
Positions 1 and 2 are used for tips and positions 3 and 4 are used to hold cups for dilution or
pretreatment. Position 5 is the position where the S/R probe pipettes sample and reagent.
Figure 1.1-45 Pipetting station
1.1.5.4 System Water Container

The system water container is located in front of the pipettors and to the right of the liquid waste
container. It holds three liters of system water. An alarm is issued when the system water container is
empty. A float mechanism sensor located beneath the aspiration inlet, triggers the alarm on the
System Overview screen.
Note: Removing the system water container while the analyzer is in Operation causes the
analyzer to enter P. Stop status.
Figure 1.1-46 System water container

1.1.5.5 Liquid Waste Container

The liquid waste container is located in front of the ProCell and CleanCell reagents. It holds four liters
of waste and issues an alarm when approximately three-quarters full. The alarm is triggered by a
weight-sensitive mechanism that activates a photosensor located in the compartment holding the
container. An alarm is also issued when the container is improperly positioned. This alarm is triggered
by a plate mechanism that activates a photosensor located at the front of the compartment.
Note: Removing the liquid waste container while the analyzer is in Operation or an improperly
positioned container causes the analyzer to enter E. Stop status.
Figure 1.1-47 Liquid waste container

1.1.5.6 Solid Waste Tray and Liner

The solid waste tray and liner is located behind the front access door on the analyzer. Used
AssayCups and tips are discarded into the waste tray during operation.
A disposable liner (Clean-Liner) made of polystyrene is placed inside the solid waste tray. The Clean-
Liner has a sliding cover to reduce potential splashing and to prevent tips and cups from falling out of
the tray upon removal from the analyzer. During operation, the sliding cover must be open. The tray
shakes periodically during operation so that used tips and cups do not accumulate at one end of the
tray.
An alarm is issued when either the tray is full (max. 1100 tips and cups) or if the tray and liner are
missing. The presence of a tray is monitored by a photosensor.
Note: Removing the solid waste tray while the analyzer is in Operation causes the analyzer to
enter E. Stop status.
Figure 1.1-48 Solid waste tray and liner

1.1.6 Measuring Area Components

The measuring area includes the incubator, aspiration station, sipper probe, sipper rinse station,
sipper pipettor, system reagents (ProCell and CleanCell) and the detection unit.
1.1.6.1 Incubator
The incubator is maintained at a specific temperature (37.0 °C ± 0.3° C) for the reaction of the sample
and the reagents that have been dispensed into a cup. The incubator is equipped with 32 positions.
When an assay is ready for measurement, the AssayCup is transferred by the gripper to the aspiration
station, and the sipper probe aspirates the reaction mixture for measurement. The aspiration station,
located in the lower right corner of the incubator, is not temperature controlled.
Figure 1.1-49 Incubator

1.1.6.2 Sipper Probe

The sipper probe aspirates the reaction mixture into the measuring cell. ProCell and CleanCell are
also aspirated by the sipper probe. The sipper probe is located to the right of the incubator. The sipper
rinse station externally washes the sipper probe with system water between measurements. When the
sipper probe is in its Stand-by position, the probe is located directly above the rinse station.
Figure 1.1-50 Sipper probe and rinse station

1.1.6.3 Sipper Pipettor

The sipper pipettor is located directly to the right of the sample/reagent syringe. They use positive
displacement of water to aspirate and dispense from the sipper probe.
Figure 1.1-51 Sipper pipettor

1.1.6.4 System Reagents (ProCell and CleanCell)

ProCell and CleanCell are located behind the liquid waste container. ProCell is the buffer solution
containing tripropylamine (TPA). These bottles are identified with white caps.
CleanCell is the cleaning solution used to clean the measuring cell after measurement. CleanCell
bottles are identified with black caps.
The reagent compartment is keyed to ensure the correct reagent is placed in the proper position. Two
bottles of each reagent are stored on the analyzer, temperature controlled at 28.0 °C ± 2.0 °C.
Figure 1.1-52 ProCell (PC) and CleanCell (CC)
When starting from Stand-by, the sipper probe always attempts to first use ProCell and CleanCell from
bottle set 2. If the quantity is insufficient, bottle set 1 is used. When starting from S. Stop or R. Stop,
the bottle set in use when the analyzer was previously in Operation is pipetted.
The analyzer can operate with one bottle set of ProCell and CleanCell reagent, but they must be
placed in positions 1 & 2 or 3 & 4. Refer to the photograph above.
Note: To have access to system reagent bottles, you must open the sipper safety cover. To open
this cover, push the cover’s metal part as shown in the picture below to release the hold. To
close the cover, push the same part until a click is heard.
Note: How to open the sipper safety cover
Figure 1.1-53 Opening/closing the sipper safety cover (Push the circled point)

Figure 1.1-54 Sipper safety cover (when opened)
CAUTION
• Do not open the sipper safety cover while the analyzer is in Operation.
Otherwise, the operation will stop.
• Be sure to close the cover after you placed/replaced system reagents, or

performed maintenance. Otherwise, the instrument will not operate.

1.1.6.5 Detection Unit

The detection unit is the core of the cobas e411 system. The detection unit contains the
photomultiplier tube, peltier, flow-through measuring cell, magnet drive assembly and an amplifier
circuit board. The temperature is maintained at 28.0 °C ± 0.3 ° C.
Figure 1.1-55 Measuring cell of the detection unit

1.1.7 Power Components
1.1.7.1 Operation Switch

The operation switch is located on the lower left front side of the analyzer. Use this switch to turn OFF
the analyzer to perform certain maintenance procedures or when the system is not in use for extended
periods of time (e.g., overnight).
Provided the circuit breaker is ON, the reagent disk and system reagent compartment temperatures
are maintained while the operation switch is OFF.
Figure 1.1-56 Operation ON/OFF switch
1.1.7.2 Circuit Breaker

The circuit breaker is located on the right side panel of the analyzer above the power supply cord. The
circuit breaker controls the power supplied to the temperature controlled reagent compartments when
the operation switch is OFF. The circuit breaker must be in the I (ON) position whenever reagents are
stored on the analyzer and to maintain liquid in the measuring cell.
When connecting or disconnecting the host cable, power the analyzer off at the circuit breaker only
Note: To disconnect the analyzer from the supply source, the circuit breaker must be in the O
(OFF) position and the power cord must be removed.
Figure 1.1-57 Circuit breaker

Figure 1.1-58
1.1.7.3 Rack Circuit Breaker

There is a circuit breaker located on the left side of the rack sampler. This controls power to the
sampler unit. The circuit breaker should be kept in the I (ON) position at all times. Use the operation
switch to power ON and OFF the rack system.
Note: To disconnect the analyzer from the supply source, the circuit breaker must be in the O
(OFF) position and the power cord must be removed.
Figure 1.1-59 Rack circuit breaker

1.1.8 Mechanical Theory
1.1.8.1 Introduction
The cobas e411 analyzer automates the immunoassay reactions utilizing electrochemiluminescence
(ECL). These reaction methods are described in detail in Chapter 4, ECL Technology. The individual
test steps and how the system performs the necessary procedures are discussed here.
1.1.8.2 Test Protocols

There are 28 test protocols or test steps that can be used on the analyzer. These protocols are
predefined by Roche Diagnostics for each test and cannot be changed by the operator.
1.1.8.3 General Assay Sequence

An immunological ECL test is made up of various pipetting steps, at least one incubation period and a
measurement step. Generally at least three test components (sample, reagent and microparticles) are
pipetted into an AssayCup. After the appropriate incubation period, the reaction mixture is aspirated
into the measuring cell where the measurement process takes place. Each of the required pipetting
cycles is performed within a defined period (42 seconds).
The number of pipetting steps, as well as the make up of the reaction mixture are dependent on the
test method (1 or 2 step test). For some methods, predilution with diluent and/or pretreatment with a
special reagent is necessary. Thus the number of pipetting steps is increased.
After each pipetting step the sample/reagent (S/R) probe tip is cleaned and, if necessary, the
microparticle mixer and sipper probe are also cleaned.
The following steps apply in principle to all methods. The sequence of the individual processes differ
from test to test.
1.1.8.4 Preparative Operations

Once the analyzer's power is switched ON, the initialization process is started. During initialization, the
mechanisms are reset to their home positions.
1.1.8.5 Run Operation

After the appropriate test selections are made in the software for patient samples, operation is started
according to the predetermined test protocol for each assay selected. Initially, at least one reagent (R1
or R2) and the sample or microparticles (M) are aspirated one after another by the S/R probe. After
each aspiration, the outside of the S/R probe tip is cleaned at the rinse station. The sample and
reagents are dispensed into a new AssayCup and the AssayTip is ejected into the solid waste tray.
For some tests that require sample dilution or pretreatment, diluent or pretreatment reagent is pipetted
together with sample into an AssayCup. An aliquot of the diluted/pretreated sample is then dispensed
with reagent into a second AssayCup. Therefore, certain tests with predilution/pretreatment may
require two or more AssayCups.
1.1.8.6 First Incubation at 37 °C

The incubation times are 4.5 or 9 minutes long, depending on the test. Some tests require only two
incubation periods, whereas tests with pretreatment tests can require three incubation periods. During
the incubation step(s) the immune complex products are formed.

1.1.8.7 Additional Reagent Pipetting

Some assays (usually those with multiple incubation steps) require additional reagent pipetting. As in
the initial reagent pipetting step, a new pipette tip is picked up prior to reagent aspiration. The S/R
probe tip is washed at the rinse station after each liquid aspiration. The liquid is then dispensed into
the corresponding AssayCup where the sample and other liquids were dispensed in the first pipetting
step.
The probe rises while dispensing the reaction mixture back into the cup, thereby mixing the solution
and accelerating the reaction in the cup. The pipette tip is ejected into the solid waste tray when
pipetting is complete.
1.1.8.8 Second Incubation at 37 °C

If necessary, a second incubation step (4.5 or 9 minutes) occurs.
If using a pretreatment assay, the second incubation is similar to that described above for "First
Incubation at 37 °C".
1.1.8.9 Additional Reagent Pipetting (Pretreatment assays)

For pretreatment assays, reagent pipetting similar to that described above for “Additional Reagent
Pipetting” occurs.
1.1.8.10 Third Incubation at 37 °C (Pretreatment assays)

If necessary, a third incubation step (9 minutes) occurs for pretreatment assays.
1.1.8.11 Reaction Mixture Aspiration and Measurement

In this process the sipper probe first aspirates ProCell (tripropylamine solution, TPA) to prepare the
measuring cell. Then, the sipper probe aspirates the reaction mixture from the AssayCup and
transfers it to the measuring cell. The sipper probe is washed at the rinse station and ProCell is
aspirated again to rinse away the unbound reagent and sample constituents. Next, the ECL reaction in
the measuring cell occurs.
1.1.8.12 Measuring Cell Cleaning

Once the measurement is complete, the measuring cell is cleaned with CleanCell and prepared for a
new measurement process.
It takes 42 seconds (one pipetting cycle) from the aspiration of the reaction mixture by the sipper
probe until the measuring cell is filled with ProCell and ready for the next sample.
1.1.8.13 Finalization
30 Minutes after documentation of the last result, the sipper pipettor flushes system water through the
sipper probe, and then fills the measuring cell with ProCell before the analyzer returns to Stand-by.
After this procedure periodically all 30 minutes the waste pump of the S/R rinse station is running for 2
seconds (waste consumption approx. 12 mL). This procedure will be stopped after you switch off the
operation switch.

1.1.8.14 Operation Flow in Analysis

An operational flow chart is shown below.
Figure 1.1-60 Operational flow chart

1.1.9 Detailed Assay Sequence

The mechanical process of the instrument is described below using a sandwich test, TSH, as an
example. This example assumes that the reagent pack was already registered by the analyzer and
does not need calibration. All results are calculated based on an existing lot calibration.
1.1.9.1 Preoperation Steps

When START (the Start Conditions screen) is pressed from Stand-by, the following preoperative steps
occur.
A. The analyzer resets all mechanisms to their respective home positions. Next, the S/R pipettor
primes the S/R probe.
B. The gripper checks for a tip in position number 1 of the tip trays. If this position is empty, the gripper
remembers where it last left off and checks that position. If this position is empty, the gripper considers
the whole tray empty and the System Overview screen is updated accordingly.
Note: If the analyzer is in S. Stop, the gripper remembers where it last left off and checks for a tip
in that position.
1. During the tip check, the S/R probe is checked for the presence of a tip. The probe moves to the
tip eject station and performs the movements to eject a tip. If a tip is present it is ejected.
2. After the tip check is complete, the AssayCups are checked in the same manner. During the cup
check, the analyzer finishes priming the probes.
3. Next, the gripper checks the last three of the five positions on the pipetting station. If a cup is
present, the analyzer goes through the steps of a cup disposal. The gripper places a tip in position
1 of the pipetting station. Then, the S/R probe picks up the tip in position 1 of the pipetting station.
The S/R probe descends into the AssayCup and attempts to aspirate any possible liquid from the
cup. The gripper picks up the cup and discards it into the cup disposal opening. As the cup is
disposed, the S/R probe moves to the rinse station and dispenses any aspirated liquid. The tip is
then washed and discarded.
4. The gripper moves to the incubator where it checks all 32 incubator positions. If a cup is present,
the gripper moves the cup to position 5 on the pipetting station and uses the same procedure
listed in step 3 to discard the cup.
5. The S/R probe tip is ejected after all the incubator positions are checked.
Figure 1.1-61
Dispense Reagent 1, Reagent 2 and Sample
A TSH sample is present on position 1 of the sample disk.
1. After preoperation functions are complete, the gripper takes a tip from the tip tray and transports it
to position 1 of the pipetting station. The gripper returns to its Stand-by position.
2. The sample disk rotates until position 1 is in the sampling position.
3. The S/R probe moves to position 1 of the pipetting station, descends to obtain the tip, rises and
returns to its Stand-by position.
4. During this time, the reagent disk rotates until the TSH reagent pack is at the cap open/close
mechanism. The mechanism moves forward and opens the caps on the reagent pack. The disk
rotates again to move the TSH reagent to the R1 position.
5. The S/R probe moves from its Stand-by position to the R1 aspiration position. While activating
liquid level detection, the probe descends until it is 2 mm below the reagent surface and aspirates
60 µL of R1.

Note: The lowest allowable point the S/R probe can descend to is 1.3 mm above the bottom of the
reagent pack.
Figure 1.1-62
While aspirating R1, the gripper puts another tip in position 1 of the pipetting station.
6. If the S/R probe does not detect liquid during descent, no reagent aspiration can occur, an alarm
is generated.
7. After R1 aspiration, the S/R probe rises and moves to the rinse station. To prevent the aspirated
R1 from contacting the water in the rinse station, the probe aspirates 10 µL of air. The rinse
station externally washes the tip.
8. During step 7, the reagent disk rotates until the TSH reagent pack is in the R2 position.
9. The S/R probe moves from the rinse station to the R2 position while aspirating another 10 µL of
air. This air layer prevents R1 from mixing with R2. While activating liquid level detection, the
probe descends until it is 2 mm below the reagent surface and aspirates 50 µL of R2. While
aspirating R2 the gripper moves an AssayCup to position 5 of the pipetting station.
10. Upon completion of R2 aspiration, the S/R probe rises and moves to the rinse station. To prevent
the aspirated R2 from contacting the water in the rinse station, the probe aspirates another 10 µL
of air. The rinse station externally washes the tip.
11. After R2 aspiration, the reagent disk rotates until the TSH reagent pack is at the cap open/close
mechanism. The mechanism moves out and closes the caps.
12. The S/R probe moves from the rinse station to the sampling position while aspirating another 10
µL of air. While activating liquid level detection, the probe descends until it is 2 mm below the
sample surface and aspirates 50 µL of sample. During sample aspiration, clot detection is
activated.

Figure 1.1-63
Figure 1.1-64
Note: Depending on the sample volumes and the type of vials used (e.g. primary sample tube or
sample cup), the sample/reagent (S/R) probe can, when necessary, be lowered further to
prevent air being aspirated. With some low capacity vials, the inside diameter is relatively
small, which means the level of the liquid sinks when the liquid is being aspirated.
13. The S/R probe moves from the sampling position to position 5 of the pipetting station. The probe
descends until the tip reaches 2 mm below where the calculated level of the reaction mixture
surface should be and dispenses the sample, R2 and R1. The probe's downward displacement is
determined by calculating the reaction mixture volume for the sample and utilizing downward
displacement tables in the software. The probe does not rise during dispense.
14. After dispense, the S/R probe moves to the tip eject position and ejects the tip.

Figure 1.1-65
Dispense Reagent 1, Reagent 2 and Sample
A TSH sample is present on position 1 of the sample rack.
1. After preoperation functions are complete, the gripper takes a tip from the tip tray and transports it
to position 1 of the pipetting station. The gripper returns to its Stand-by position.
2. The pusher arm pushes the racks in the A-Line forward to the B-Line. The arm returns to its home
position. The first rack loads on the B-Line.
3. As the rack incrementally moves on the B-Line, the rack bar code reader scans all five rack
positions and rack ID. When scanning is complete, position 1 of the rack is in the sampling
position.
4. The S/R probe moves to position 1 of the pipetting station, descends to obtain the tip, rises and
returns to its Stand-by position.
5. During this time, the reagent disk rotates until the TSH reagent pack is at the cap open/close
mechanism. The mechanism moves forward and opens the caps on the reagent pack. The disk
rotates again to move the TSH reagent to the R1 position.
6. The S/R probe moves from its Stand-by position to the R1 aspiration position. While activating
liquid level detection, the probe descends until it is 2 mm below the reagent surface and aspirates
60 µL of R1.
Figure 1.1-66
Note: The lowest allowable point the S/R probe can descend to is 1.3 mm above the bottom of the
reagent pack.
While aspirating R1, the gripper puts another tip in position 1 of the pipetting station.
7. If the S/R probe does not detect liquid during descent, no reagent aspiration can occur, an alarm
is generated.
8. After R1 aspiration, the S/R probe rises and moves to the rinse station. To prevent the aspirated
R1 from contacting the water in the rinse station, the probe aspirates 10 µL of air. The rinse
station externally washes the tip.
9. During step 8, the reagent disk rotates until the TSH reagent pack is in the R2 position.
10. The S/R probe moves from the rinse station to the R2 position while aspirating another 10 µL of
air. This air layer prevents R1 from mixing with R2. While activating liquid level detection, the
probe descends until it is 2 mm below the reagent surface and aspirates 50 µL of R2. While
aspirating R2 the gripper moves an AssayCup to position 5 of the pipetting station.

Figure 1.1-67
11. Upon completion of R2 aspiration, the S/R probe rises and moves to the rinse station. To prevent
the aspirated R2 from contacting the water in the rinse station, the probe aspirates another 10 µL
of air. The rinse station externally washes the tip.
12. After R2 aspiration, the reagent disk rotates until the TSH reagent pack is at the cap open/close
mechanism. The mechanism moves out and closes the caps.
13. The S/R probe moves from the rinse station to the sampling position while aspirating another 10
µL of air. While activating liquid level detection, the probe descends until it is 2 mm below the
sample surface and aspirates 50 µL of sample. During sample aspiration, clot detection is
activated.
Figure 1.1-68
Note: Depending on the sample volumes and the type of vials used (e.g. primary sample tube or
sample cup), the sample/reagent (S/R) probe can, when necessary, be lowered further to
prevent air being aspirated. With some low capacity vials, the inside diameter is relatively
small, which means the level of the liquid sinks when the liquid is being aspirated.
14. The S/R probe moves from the sampling position to position 5 of the pipetting station. The probe
descends until the tip reaches 2 mm below where the calculated level of the reaction mixture
surface should be and dispenses the sample, R2 and R1. The probe's downward displacement is
determined by calculating the reaction mixture volume for the sample and utilizing downward
displacement tables in the software. The probe does not rise during dispense.
15. After dispense, the S/R probe moves to the tip eject position and ejects the tip.

1.1.9.2 First Incubation

1. The gripper grasps and transports the cup containing the reaction mixture from the pipetting
station to the incubator.
2. The cup is incubated at 37 °C for 9 minutes.
3. During incubation, the analyzer continues to perform operations for other test(s) or sample(s), if
necessary.
1.1.9.3 Microparticle Preparation

Before the first incubation is completed, the TSH microparticles are mixed to facilitate microparticle
aspiration and dispense.
1. The reagent disk rotates until the TSH reagent pack is at the reagent cap open/close mechanism.
The mechanism moves out and opens the cap. The disk moves the reagent pack to the mixing
position.
2. The mixer moves over the reagent disk and descends into the microparticles to a level 1.4 mm
above the bottom of the bottle.
Figure 1.1-69
Note: The mixer descends to this level regardless of the volume of microparticles in the bottle.
3. The mixer stirs the microparticles for approximately 4 seconds to obtain a homogeneous
suspension. During the mixing, the gripper obtains a fresh AssayTip and transports it to position 2
of the pipetting station.
4. When mixing is complete, the mixer rises and returns to the rinse station where it descends and
rotates in the rinse station for washing.
5. At the same time, the reagent disk rotates the TSH reagent pack to the microparticle pipetting
position.
1.1.9.4 Microparticle Aspiration and Dispense

1. The gripper grasps the incubating cup and transports it to position 5 of the pipetting station.
2. The S/R probe moves to the pipetting station and obtains the fresh tip and moves to the
microparticle pipetting position.
3. While activating the liquid level detection, the S/R probe descends to 2 mm below the reagent
surface and aspirates 40 µL of microparticles.
4. After reagent aspiration, the S/R probe rises, moves to position 5 of the pipetting station and
descends to dispense the microparticles.
5. After dispense, the S/R probe descends further until it is 0.8 mm above the bottom of the cup and
aspirates the entire volume of reaction mixture. The probe rises while dispensing the reaction
mixture back into the cup, thereby mixing the solution and accelerating the reaction in the cup.
This mixing takes place only once.

6. The S/R probe moves to the tip eject position and discards the tip.
Figure 1.1-70
1.1.9.5 Second Incubation

1. The gripper grasps the cup containing the mixed reaction mixture and returns it to the incubator.
2. The cup is incubated at 37 °C for 9 minutes.
3. During incubation, the analyzer continues to perform operations for other test(s) or sample(s), if
necessary.

1.1.9.6 Measurement Process Preparations

Before the second incubation is completed, the sipper probe aspirates ProCell into the measuring cell
to facilitate measurement.
1. The sipper probe moves from its home position to a ProCell bottle and descends to 2 mm below
the solution level and aspirates ProCell into the measuring cell. During descent, liquid level
detection is activated.
Note: The sipper probe can descend as low as 1.3 mm above the bottom of the ProCell bottle.
2. The sipper probe rises.
1.1.9.7 Measurement Process

1. The gripper grasps and transports the cup that has completed its second incubation from the
incubator to the aspiration station.
2. The sipper probe moves to the aspiration station and descends into the cup until it is 0.8 mm
above the cup bottom. This descent is independent of the reaction mixture volume.
3. When the sipper probe detects the reaction mixture in the cup, it aspirates 150 µL.
4. After aspiration, the sipper probe rises, aspirates 10 µL of air and moves to the sipper rinse station
to descend for rinsing.
5. The gripper grasps the cup from the aspiration station, transports it to the cup disposal opening
and discards the cup.
6. The sipper probe is rinsed.
7. The sipper probe rises and moves to the ProCell position, descends into the bottle and aspirates
ProCell in a set aspiration/dispense sequence. The immune complex is captured by the magnet
onto the electrode of the measuring cell. The ProCell washes away all unbound reagent and
serum constituents.
8. After the bound-free separation, a voltage is applied between the working electrode and the
counter electrode. The ECL reaction is initiated and measured by the photomultiplier.
9. After measurement, the sipper probe rises and moves to the CleanCell position and aspirates 20
µL of air. The probe then descends into the CleanCell bottle and aspirates reagent. This
procedure is repeated eight times. The alternate flow of air and cleaning solution washes the
measuring cell. During this washing process, a voltage is applied between the electrodes, which
aids in the cleaning process.
10. The sipper probe moves to the sipper rinse station, aspirates 20 µL of air and descends into the
rinse station for washing.
11. Finally, the sipper probe rises and moves to the ProCell bottle. The probe descends into the bottle
and aspirates 500 µL of ProCell. Next, the probe aspirates 90 µL of ProCell and moves to the
rinse station. At the rinse station, the probe dispenses 35 µL to flush the probe and prepare it for
the next sample. During the aspirations of the ProCell, a sequence of voltages is applied three
times to prepare the electrodes for the next measurement. One cycle of the measurement process
consumes approximately 2 mL each of ProCell and CleanCell.

1.1.9.8 Signal Detection and Conversion

The measuring cell is kept at a constant 28 °C throughout the measurement process. The
photomultiplier tube detects and converts the ECL signal into an electric signal from which the e411
calculates assay results. For details on this process, refer to Chapter 4, ECL Technology.
1.1.9.9 Automatic Analyzer Cycles

There are certain analyzer functions that occur automatically while the analyzer is powered ON.
• While in Operation, the solid waste tray periodically shakes for 1.5 seconds.
• While in Stand-by, the reagent disk turns 90° every 30 minutes.
• While in Stand-by, the rinse stations for the S/R probe and sipper probe are switched on for 3
seconds every 30 minutes.
• Microparticles undergo a long mix when starting from Stand-by and then every 90 minutes, when
pipetting not yet started.
• Microparticles undergo a short mix (approx. 4 seconds) and then a short mix every 60 minutes for
each reagent pack.

1.1.10 Dilution Steps

The following is a description of how an assay with a dilution is performed, including the number of
AssayTips and AssayCups used in the process.
1.1.10.1 Assay With One Step Dilution (1:2, 1:5, 1:10, 1:20)
Tip 1 -> diluent (wash)* + sample -> cup 1
Tip 2 -> R1 (wash)* + R2 (wash)* + diluted sample from cup 1 -> cup 2 ... 1st incubation
Tip 3 -> M (wash)* -> cup 2 ... 2nd incubation
Detection
* (wash) = the outside of the AssayTip is washed.
R1 = Reagent 1
R2 = Reagent 2
M = Microparticles
1.1.10.2 Assay With Two Step Dilution (1:20, 1:50, 1:100, 1:400)
Tip 1 -> diluent (wash)* + sample -> cup 1
Tip 2 -> R1 (wash)* + diluted sample from cup 1 -> cup 2
Tip 3 -> R1 (wash)* + R2 (wash)* + diluted sample from cup 2 -> cup 3 … 1st incubation
Tip 4 -> M (wash)* -> cup 3 … 2nd incubation
Detection
R1 = Reagent 1
R2 = Reagent 2
M = Microparticles
1.1.10.3 Pretreatment Steps

In certain test protocols, pretreatment reagent is added prior to R1, R2 or M.
Pretreatment Assay (3 tips and 1 cup)

Tip 1 -> PT1 (wash)* + PT2 (wash)* + sample -> cup 1 1st incubation
Tip 2 -> R1 + pretreated sample in cup 1 -> cup 1 2nd incubation
Tip 3 -> M (wash)* + R2 + reaction mixture in cup 1 -> cup 1 3rd incubation
Detection
PT1 = Pretreatment 1
PT2 = Pretreatment 2
R1 = Reagent 1
R2 = Reagent 2
M = Microparticles

1.1.11 Analyzer Status Conditions
The e411 analyzer can occupy a number of status conditions. A table of the status conditions you
normally see during routine operation or maintenance procedures is listed below. There are several
other conditions that exist; however, most of these status conditions are seen during various
adjustment or maintenance procedures performed by a Roche Diagnostics representative. These
additional status conditions are not included in the table below.
Figure 1.1-71
1.1.11.2 A. Stop (Analyzer Stop)

The analyzer is no longer able to continue operation. An alarm was issued. Take the appropriate
measures to resolve the problem. For further details on A. Stop, refer to Chapter 7, Instrument Alarms
- List.
Figure 1.1-72
1.1.11.3 A. Stop/L. Stop (Analyzer Stop/Line Stop)

The analyzer is already in A. Stop status when the lines stop operation. For further details on A. Stop
and L. Stop, refer to Chapter 7, Instrument Alarms – List.
Figure 1.1-73
1.1.11.4 A. Stop/R. Stop (Analyzer Stop/Rack Stop)

The analyzer is already in A. Stop status when the A-Line stops supplying racks to the B-Line. For
further details on A. Stop and R. Stop, refer to Chapter 7, Instrument Alarms - List
1.1.11.5 BC card scan

This status is seen when a bar code card scan is initiated from the BC Read pop-up window
(QC/Calibration -> Install -> touch the Scan BC Card button).
1.1.11.6 E. Stop (Emergency Stop)

An emergency stop condition exists. An alarm was issued. Take the appropriate measures to resolve
the problem. For further details on E. Stop, refer to Chapter 7, Instrument Alarms - List.
1.1.11.7 Finalization
The status of the analyzer when it is between the status conditions S. Stop and Stand-by.

1.1.11.8 Finalization maint.

This status occurs when Finalization Maintenance is initiated from the Finalization Maintenance pop-
up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select
“Finalization Maintenance” from the maintenance items list -> then touch the Select button).
1.1.11.9 Initialization
This status is seen when the e411 is powered ON or when START is pressed from Stand-by.
Figure 1.1-74
1.1.11.10 L. & A. reset all (Line & Analyzer)

L. and A. reset all status occurs when the corresponding function is initiated from the L. and A. Rest
All pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list ->
select “L. And A. Reset All” from the maintenance items list -> then touch the Select button). This
function resets the analyzer and the lines.
Figure 1.1-75
1.1.11.11 L. Stop (Line Stop)

All lines stop operation. An alarm was issued. Take the appropriate measures to resolve the problem.
For further details on L. Stop, refer to Chapter 7, Instrument Alarms – List.
1.1.11.12 Liquid flow cleaning

Liquid flow cleaning occurs when this function is initiated from the Liquid Flow Cleaning pop-up
window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select
“Liquid Flow Cleaning” from the maintenance items list -> then touch the Select button).
1.1.11.13 M. Cell preparation

Measuring cell (M. Cell) preparation occurs when this function is initiated from the Measuring Cell
Preparation pop-up window (Utility -> Maintenance -> select “Maintenance” from the maintenance
type list -> select “Measuring Cell Preparation” from the maintenance items list -> then touch the
Select button).
1.1.11.14 Operation
This is the status during which the e411 performs its routine operations.
1.1.11.15 P. Stop (Partial Stop)

A partial stop condition exists. An alarm was issued. Take the appropriate measures to resolve the
problem. For further details on P. Stop, refer to Chapter 7, Instrument Alarms - List.
Figure 1.1-76

1.1.11.16 R. Stop (Rack Stop)

This status occurs when there are no more racks to process on the A-Line or B-Line.
Figure 1.1-77
1.1.11.17 Rack clear

Rack clear status occurs when the corresponding function is initiated from the Rack Clear pop-up
window (Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Rack
Clear” from the maintenance items list -> then touch the Select button). This function clears any
remaining racks on the A-, B- or C-Lines.
1.1.11.18 Reagent scan

This status is seen when a reagent scan is initiated from the RScan pop-up window (Reagent ->
Setting -> RScan button).
1.1.11.19 S/R pipettor prime

This status occurs when the S/R pipettor prime is initiated from the S/R Pipettor Prime pop-up window
(Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “S/R Pipettor
Prime” from the maintenance items list -> then touch the Select button).
1.1.11.20 S/R probe LLD volt.

This status is seen when the analyzer is monitoring the liquid level detection voltage of the S/R probe.
The check is initiated from the S/R Probe LLD Check pop-up window (Utility -> Maintenance -> select
“Check” from the maintenance type list -> select “S/R Probe LLD Check” from the maintenance items
list -> then touch the Select button).
Figure 1.1-78
1.1.11.21 S. Stop (Sampling Stop)

This status occurs when the S. Stop global button is pressed or when sampling is complete.
Figure 1.1-79
1.1.11.22 S. Stop-S. Scan

The analyzer is in S. Stop and a sample scan is requested from the Sample Tracking screen.
Figure 1.1-80
1.1.11.23 Sample scan

This status occurs when a sample scan is initiated from the Sample Tracking screen.

1.1.11.24 Sipper LLD volt.

The analyzer is monitoring the liquid level detection voltage of the sipper probe. The check is initiated
from the Voltage Monitor pop-up window (Utility -> Maintenance -> select “Maintenance” from the
maintenance type list -> select “Voltage Monitor” from the maintenance items list -> then touch the
Select button).
1.1.11.25 Sipper pipet. prime

This status occurs when the sipper prime is initiated from the Sipper Pipettor Prime pop-up window
(Utility -> Maintenance -> select “Maintenance” from the maintenance type list -> select “Sipper
Pipettor Prime” from the maintenance items list -> then touch the Select button).
1.1.11.26 Stand-by
The analyzer is not performing any operations.
1.1.11.27 Stop
This status occurs when the Stop global button is pressed or when a Stop alarm condition exists. If an
alarm exists, take the appropriate measures to resolve the problem. For further details on Stop, refer
to Chapter 7, Instrument Alarms - List.
1.1.11.28 System reset

A system reset is initiated from the System Reset pop-up window (Utility -> Maintenance -> select
“Maintenance” from the maintenance type list -> select “System Reset” from the maintenance items
list -> then touch the Select button).

1.2 Technical Data
1.2.1 Technical Data for Operation of Instrument
1.2.1.1 Instrument Dimensions

Analyzer Height Depth Width Weight
31.4 in 29.4 in 47.2 in 375 lbs
80 cm 74.5 cm 120 cm 170 kg
[43 in, 109 cm with
top cover opened]
[24.2 in, 61.5 cm
without control unit]
31.4 in 37.4 in 67 in 529 lbs

80 cm 95 cm 170 cm 240 kg
[43 in, 109 cm with
top cover opened]
[24.2 in, 61.5 cm
without control unit]
1.2.1.2 Electrical
Installation requirements Pollution degree: 2 (IEC 61010-1)
Overvoltage category: II (IEC 664)
The cobas e411 analyzer must be connected to a three-wire
power supply cord with a safety ground.
AC Cord
For countries which require UL and A UL-listed and CSA-certified AC cord set must be used.
CSA compliance (A cord with a plug and a connector)
Recommended rate
Supply voltage : 115 V AC125V-15A / SJT type 3×14AWG
Supply voltage : 208 or 240 V AC250V-10A / SJT type 3×16AWG
Temperature rate Min 60°C
Whole length 2500±50mm
Safety Standard UL817 / CSA C22.2 No.21
For European countries An HAR-certified AC cord must be used.
(A cord with a plug and a connector)
Recommended rate
Supply voltage : 220 to 240 V AC250V-10A / 3×1.0 mm2
Temperature rate Min 60°C
Whole length 2500±50mm
Safety Standard CENELEC HD21
Connector Type connected to IEC320 / EN60320 type
e411 inlet
Supply voltage/frequency 100-240 VAC 50/60 Hz Single-phase

The ratings of the AC cord set to be used must be consistent
with the ratings of the customer equipment.
Power consumption Disk system: 1000VA
Rack system: 1250VA (Rack sampler unit: 250VA)
Heat generation Analyzer unit: approx. 2,879 kJ/hr resp.

688 kcal/hr resp. 2,730 Btu/hr

Rack sampler unit: approx. 899 kJ/hr resp.
215 kcal/hr resp. 853 Btu/hr
Main supply voltage fluctuation ±10% of nominal voltage (90 VAC to 264 VAC)
1.2.1.3 Environmental Conditions

Temperature During measurement During transportation and
storage
18 °C to 32 °C (64.4 °F to 89.6 °F) -20 °C to 75 °C (-4 °F to 167 °F)
Temperature variation Max. ± 2 °C/hour (Max. ± 3.6 °F/hour)
Humidity 20% to 80% 5% to 95%
Indoor use only
Altitude up to 2000m
1.2.1.4 Noise Level (DIN 43635)

Stand-by level 60 dBA
Operation level (average) 63 dBA
Operation level (maximum) 70 dBA
1.2.1.5 Water Supply

Water container 3 Liters
Water requirements < 10 µS/cm or > 0.1 megohm, bacteria-free
Water consumption approx. 3 L for 250 tests
approx. 12 mL/cycle
1.2.1.6 Liquid Waste

Liquid waste container 4 Liters
1.2.1.7 Throughput Rate

Assay measurements max. 85 tests/hour

1.2.1.8 Sampling System

Sample/Reagent pipettor principle conductive disposable tip handling
Sample volume per test 10 µL to 50 µL
Sample detection Liquid level detection and clot detection
Sample loading capacity
Figure 1.2-1
30 positions for samples, controls and calibrators
Figure 1.2-2
tray - 15 racks with 5 positions each for samples, controls and
calibrators = 75
tray with input buffer - 20 racks with 5
positions each = 100
STAT capacity
Figure 1.2-3
any unoccupied position on the sample disk
Figure 1.2-4
STAT position at the front of the analyzer
Bar code symbologies PDF417
NW7 (Codabar)
Code 39
Code 128
Interleaved 2 of 5
AssayTips 360 tips (3 trays; 120 tips/tray)
AssayCups 180 cups (3 trays; 60 cups/tray)
Sample cups 2 mL (Standard) Hitachi cup; NO micro cups
Primary sample tubes 13 x 75 mm 16 x 75 mm
(external diameter x height): 13 x 100 mm 16 x 100 mm

1.2.1.9 Sample Barcode Specification

Table 1.2-1 No. of ID digits
Code symbol No. of ID digits Check character format
NW7: 3 to 13 digits (w/o check digit) Modulus 16, Modulus 11,
6 digits + 1 digit (with check digit) Weight Modulus 11, Modulus
10/2 Weight, Modulus 10/2
Weight-A, Modulus 10/3
Weight and 7 check
DR;Configurable via software.
Code 39: 3 to 13 digits (w/o check digit) Modulus 43
3 to 13 digits + 1 digit (with check digit)
Interleaved2 to 5: 4 to 12 digits (w/o check digit) Modulus 10 alternate 1, 3
3 to 13 digits + 1 digit (with check digit) weight
Code 128: Set C; 4 to 12 digits + 2 digits (with Modulus 103
check digit)
“NW 7” allows the use of 6 digits + 1 digit with check digit.
In case of “Interleaved 2 to 5”, the number of ID digit is fixed (at an even number of digit).
For “Code 128”, the check digit should be always given.
With or w/o check digit has to be chosen. Mixed use is not available.
Table 1.2-2 Character usable for ID

NW7: 0 to 9 (w/o check digit)
0 to 9, -, /, ., $, :, + (with check digit)
Code 39: 0 to 9, A to Z, -, /, ., +, [space], $, %
Interleaved 2 to 5: 0 to 9
Code 128: Alphanumeric characters, excluding Non-data function
characters and code set selection characters.
Label size
The label size when attaching it with reference to the uppermost edge of the test tube mouth is shown
in Figure 1.2-6.
A quiet zone of more than 5mm should be provided at both ends of the symbol as shown in Figure
1.2-5.
However, for RD calibrator/control vials, a quiet zone of more than 3mm should be provided at both
ends of the symbol as shown in Figure 1.2-6.
Bar and Space

Minimum bar (space) width: >0.19mm
Ratio of narrow bar (space) to wide bar 1 : 2.5 to 3
(space):
Reference and PCS value (The values comply with the ANSI X3.182:Bar Code Quality Guideline)
Reference of space: 70% or higher
PCS value: 0.7 or more
Color
Bar: Black
Space: White

Figure 1.2-5 Bar code label
Figure 1.2-6 Bar code read zone

The bar code label must be attached to each test tube in bar code zone as shown in Figure 1.2-7.
Figure 1.2-7 Attachment of Bar code label to Test Tube and vial
1 Test tube
2 Bar code zone
3 Vial
4 Bar code label

Sample ID, when using the secondary tube for sample vessel, is by putting sample cup on the test
tube with bar code label (Cup on Tube) as shown in Figure 1.2-8, Figure 1.2-9.
Setting Procedure 1 Setting Procedure 2
Method Sample Cup + Test Tube Test Tube alone
Assembly
Figure 1.2-9 Sample ID by Cup on

Figure 1.2-8 Sample ID by Cup on Tube
Tube
1 Test tube
1 Sample cup
2 Test Tube
3 Bar code label
Figure 1.2-10
Sample Disk dead volume

"Normal" dead "Reduced" dead
Sample Container Tube height
volume volume
standard Hitachi cup directly on the sample -- 200 µL 100 µL
disk
standard Hitachi cup on top of a primary 75 mm 200 µL 150 µL
sample tube (o = 16 mm)
primary sample tube (o = 13 mm) 75 mm 600 µL --
calibrator/control vial -- 150 µL
∗ 1: There is no assignation of “Normal” or “Reduced (Others)” for the dead volume of RD Calibrator/Control vial.
CAUTION
A reduced dead volume may only
be used with Hitachi standard cups
(not with primary or secondary
cups).
Figure 1.2-11
Table 1.2-3 Sample Rack dead volume

"Normal" dead "Reduced" dead

Sample Container Tube height
volume volume
standard Hitachi cup directly on the sample -- 200 µL 100 µL
rack
primary sample tube (o = 13 mm) 100 mm 600 µ --
calibrator/control vial -- 150 µL
∗ 1: There is no assignation of “Normal” or “Reduced (Others)” for the dead volume of RD Calibrator/Control vial.

Reagent System
Reagent disk temperature 20 °C ± 3 °C (68 °F ± 5.4 °F)
Reagent capacity in any combinations in 18 reagent positions with the
exception of the following restrictions: At the same time not
more than 18 tests, 9 pretreatments or 8 diluents.
R1/R2 consumption 50 to 80 µL per reagent dependent upon the assay
Microparticle consumption 30 to 50 µL dependent upon the assay
Reagent detection liquid level detection
Positive reagent identification 2-dimensional bar code (PDF417)
Automatic dilution available up to 1:400
Evaporation protection reagents are automatically opened and closed
Inventory control automatic based on counting (reagent disk) or liquid level
detection (ProCell/CleanCell)
Incubation System
Incubator capacity 32 AssayCups
Volume of AssayCups 200 µL
Incubation temperature 37.0 °C ± 0.3 °C (98.6 °F ± 0.5 °F)
Measuring System
Measuring method integral measuring of an electrochemiluminescence signal
Calibration mode 2-point calibration
Test protocols 28 test methods
ProCell consumption approx. 2 mL per cycle
CleanCell consumption approx. 2 mL per cycle
Cycle time 42 sec.
Control Unit
Compact flash card
Host interface CCITT V. 24/RS-232-C (bidirectional)
The host computer should comply with the requirements of
IEC (60950).
External printer Connected via the USB port
Optional module Laboratory System Manager (LSM)
Touchscreen monitor 38 cm (15 in) color TFT-LCD, XGA

1.3 Potential Hazard and Safety Precautions
1.3.1 Safety Classifications

Before operating with the cobas e411, it is essential that the warnings, cautions, and safety
requirements contained in this manual, as well as the explanation of warning and biohazard symbols
marked on the analyzer are read and understood by the service engineer.
This section explains how precautionary information is formatted in this manual.
See 1.3.3 “Safety Labels of the System” in this chapter.
The safety precautions and important user notes are classified according to ANSI Z535 standards.
Familiarize yourself with the following meanings and icons:
WARNING
Indicates a possibly hazardous
situation which, if not avoided,
may result in death or serious
injury.
Indicates documentation must
be consulted in all cases where
this symbol is marked.
WARNING
Indicates that samples containing
material of human origin must be
treated as potentially infectious. The
relevant laboratory guidelines on
safe use must be observed.
CAUTION
Indicates a possibly hazardous
situation which, if not avoided,
may result in slight or minor
injuries, damage to equipment,
inaccurate results or loss of
result data.
“Minor injury” refers to injuries
that may require medical
assistance.
“Equipment” refers to extended
damage to buildings, furniture,
and so on.
Note: Notes contain information about a topic in the text.

1.3.2 Safety Information

Make sure that you follow the safety precautions and instructions described in this manual. Otherwise,
personal injuries, damage to the instrument or malfunctions may result.
For corresponding labels and their positions, see Safety Labels on the cobas e411.
• DO NOT open the back cover and service cover with the power switch or circuit
breaker turned on. Otherwise, you may receive an electrical shock.
• DO NOT open the Detection unit cover with the power switch or circuit breaker
turned on. Otherwise, you may receive an electrical shock. Corresponding label: L
• DO NOT open the cover of the PMT high voltage supply circuit board with the
power switch or circuit breaker turned on. Touching the board may cause death
or severe injury. Corresponding label: K
• Before starting operation or after maintenance/checks, be sure that all analyzer

covers are closed. DO NOT open the analyzer covers while the analyzer is in
operation.
• Avoid touching the A-, B-, or C-Lines, sample/reagent probe mechanism, sipper
probe mechanism, gripper (tip/cup carrier) mechanism, beads mixing
mechanism, cap opener mechanism, and other moving parts while the analyzer is
operating. therwise, personal injury may result. Corresponding label: C (for the
cap opener mechanism)
• Make sure the analyzer is in S. Stop status when you load additional samples
onto the sample disk or remove processed samples from the sample disk while
the analyzer is operating. Otherwise, personal injury may result.
• Verify there is no rack movement and rack indication light is green when you load
additional sample racks on the A-Line or remove processed sample racks from
the C-Line while the analyzer is operating. Otherwise, personal injury may result.
• DO NOT wear loose garments or jewelry that could catch in moving mechanisms
and cause you to hit other mechanisms.
• Before placing additional samples onto the sample disk, or replacing the sample
disk during operation, make sure that the analyzer is in S. Stop status. And then
be sure to raise the sample disk protective cover before placing the samples or
taking out the disk.
• Avoid touching the cooling fan of the detection unit while the analyzer is
operating. Otherwise, personal injury may result. To clean the fan, be sure to turn
OFF the analyzer.
• DO NOT insert your finger into the openings on the reagent disk cover.
Otherwise, personal injury may result.
• Open/close the analyzer top cover quietly. Otherwise, personal injury may result.

• Use the personal protective equipment (such as rubber gloves, lab coat, safety
glasses, etc.) recommended by your facility when handling biohazardous
materials.
• Be sure to wear personal protective equipment (such as rubber gloves, lab

coat, safety glasses, etc.) before performing any maintenance/checks, and
follow the procedure described in this manual.
• Avoid direct contact with samples, which may be biohazardous materials. If

sample spills on the analyzer, wear protective equipment and wipe it off
immediately and apply disinfectant.
• Avoid direct contact with the sample/reagent probe, sample disk protective
cover, sipper probe, and rinse stations. Treat these components as potentially
biohazardous area. Corresponding label: A, B and E
• Avoid direct contact with waste solution and/or solid waste. Both should be
handled as potentially biohazardous materials. Corresponding label: H and I
• Before any maintenance/checks, be sure to wear protective equipment (such

as rubber gloves, lab coat, safety glasses, etc.) and follow the instruction
specified in this operational manual.
• Direct contact with sample may result in infection. Be sure to wear protective
equipment and follow the instruction specified in this operational manual.
• If sample or reagent contacts your skin, wash it off immediately with water and
apply a disinfectant. Consult a physician.
• DO NOT wear loose garments or jewelry that could catch in moving

mechanisms and cause you to make contact with the sipper or S/R probe and
lead you to infection. Corresponding label: A and E
• Avoid direct contact with CleanCell. Direct contact with the reagent may result
in skin irritation or damage. Refer to the CleanCell box label for specific
instructions. Corresponding label: G
• Avoid direct contact with reagents. Direct contact with reagents may result
irritation or damage in the skin. Refer to the reagent kit box labels for
instructions.
DO NOT add bleach or strong alkaline disinfectants (pH > 9.5) to the liquid waste
container. Disinfectants combined with the contents of the liquid waste could cause
potentially harmful fumes.
Avoid using dangerous flammables around the instrument. Fire or explosion may
be caused by ignition.

Isopropyl alcohol is a highly flammable material. When performing maintenance

using isopropyl alcohol, make sure there are no open flames around. Otherwise, a
fire and severe burns may result.
• Dispose of waste solution and/or solid wastes according to the relevant

governmental regulations
• Consult the reagent manufacturer for information on the concentrations of

heavy metals and other toxic constituents in each reagent.
• Avoid all kinds of liquid spillage on the instrument.
Power must be off to move mechanical components. If power is on, the motors are
engaged and attempted movement may damage these components.
• DO NOT touch the sampling, sipper, gripper, or microparticle mixer

mechanisms until the analyzer enters S. Stop status. Instrument malfunctions
or damage may result.
• Be careful not to damage the lower end of the S/R probe during cleaning.
Make sure the analyzer is in S. Stop status when you load additional samples onto
the sample disk or remove processed samples from the sample disk while the
analyzer is operating. Otherwise, the instrument may be damaged or operation may
be stopped.
• DO NOT touch the reagent disk while the analyzer is in operation. Otherwise,
the instrument may be damaged, or operation may be stopped.
• DO NOT open the reagent disk cover, except for replacement of reagents.
Otherwise, this may compromise the cooling efficiency or cause deterioration of
the reagents. Opening of the cover during analysis also causes an instrument
alarm.
• Be sure to put the cover on the reagent disk before you start operation or after
you placed/replaced reagents. Otherwise, operation will not start.
Verify that the lights on the rack sampler is green, prior to adding a new rack or tray
to the A-Line or removing a tray of processed samples from the C-Line while the
analyzer is in Operation. Otherwise, the instrument may be damaged or operation
may be stopped.

Be careful not to bend the microparticle mixer. A bent mixer could lead to
inaccurate results.
Be careful not to damage the lower end of the sipper probe during cleaning.
• Do not open the sipper safety cover while the analyzer is in operation.
Otherwise, the operation will stop. DO NOT open the sipper safety cover unless
the analyzer is in Stand-by.Corresponding label: F
• Be sure to close the cover after you placed/replaced system reagents, or

performed maintenance. Otherwise, the analyzer will not operate.
Corresponding label: F
• To open/close the sipper safety cover, press the proper spot that is indicated in
this manual. See 1.1.6 Measuring Area Component.
Insoluble contaminants such as fibrin and dust in samples may cause probe
clogging and thus lead to pipetting volume shortage and deterioration in
measurement accuracy. When loading samples on the analyzer, make sure that
samples contain no insoluble contaminants such as fibrin or dust.
On occurrence of momentary power voltage drop due to power interruption or

lightning, the control unit of the instrument may become faulty, or the system
software, application software or data may damaged. In addition, instrument
malfunctions or operating errors may cause damage to result data or assay
parameters. To prevent such losses, be sure to back up result data and assay
parameters periodically.
Sample or reagent spillage on the instrument surface may cause instrument
malfunctions. DO NOT place samples or reagents on the instrument unless
otherwise indicated.
If a malfunction occurs in the touch screen monitor and you cannot use it, contact a
Roche Diagnostics service representative. And in such cases, please use the
auxiliary USB mouse to operate the instrument until the service representative
arrives.
• For proper use of the instrument, measure control samples and monitor the
instrument during operation.
• An incorrectly measured result may lead to an error in diagnosis, therefore

posing danger to the patient.
• Do not use reagents that are expired. Otherwise, inaccurate data may be
obtained.
• Films or bubbles in sample or reagent may cause pipetting volume shortages

and thus lead to inaccurate measurement results. Before you set samples or
reagents, check if there are films or bubbles in them.

• This instrument is designed for clinical immunological test analysis using

water-soluble samples and reagents.
• Please note that other analyses may not be applicable to this instrument.
• Operation should be conducted under the management of a technician who

has undergone training at the facility specified by the sales agent. ( For clinical
tests, the instrument should be used under the management of a doctor or
clinical inspector.
• During operation and maintenance of the instrument, proceed according to the

instructions and do not touch any parts of the instrument other than those
specified.
• Carefully follow the procedures specified in the operator’s manual and this
manual for maintenance of the analyzer.
• AssayCups, AssayTips, the detection unit and liquid waste container or solid
waste tray and liner are not guaranteed to be chemically resistant against
organic solvents. Therefore, do not use organic solvents on these parts.
• Avoid using samples and reagent solutions that are likely to adhere to
AssayTips, AssayCups, the liquid waste container or detection unit.
Never switch on the power within one second of switching it off.
If the instrument will not be used for a long period of time (i.e., > 7 days), Different
shutdown procedures are recommended depending upon the duration of inactivity.
Devices that emit electromagnetic waves may affect measured data, or cause
the instrument to malfunction. DO NOT operate the following devices in the
same room where the instrument is installed:
Mobile phones, cordless phones, other electrical devices that generate
electromagnetic waves.
• Only trained Roche Support personnel, or similarly qualified personnel

supervised by authorized service agents of Roche Diagnostics, are qualified
to install, transport, and dispose of the cobas e411.
• At least two persons must carry the instrument, by holding the base plates
on the left side and right side of the analyzer. Be careful not to hurt your
hands or fingers when putting the instrument in place.
• Follow the specified installation conditions carefully. Otherwise, inaccurate

results or damage to the analyzer may occur.
• The cobas e411 is provided with more than one power supply cords. Make

sure that all the power supply cords are removed when disconnecting the
instrument from the main supply source.
A reduced dead volume may only be used with Hitachi standard cups (not with
primary or secondary cups).
Micro cups cannot be used on the e411 analyzer!
Be sure to lay down the sample disk protective cover before you start operation.
If you load additional AssayTip/Cup trays onto the analyzer while the analyzer is
in operation, be sure to place them only in the positions indicated by the software
screen as accessible.
When loading a rack into the STAT position, check the orientation of the rack.
An improperly oriented rack may cause instrument damage.
Corresponding label: J

1.3.3 Safety Labels on the cobas e411
Figure 1.3-1
Figure 1.3-2

Figure 1.3-3
Table 1.3-1
Symbol Validity Position Symbol Validity Position
S/R Probe A Sipper Safety Cover F
Sample Disk B S/R Probe, Sipper D

Protective Cover Probe
Sipper Probe E Cover of the PMT high K
voltage supply circuit
board
Liquid Waste Tank H Cover of Detection L
Unit
Solid Waste Tray I
Cap Opener C Liquid Waste Tank G
STAT position J

1.3.4 Approvals
The cobas e411 analyzer meets the requirements stated in Directive 98/79/EC of the European
Parliament and the Council of the European Union (EU) on in vitro diagnostic medical devices.
Furthermore, the cobas e411 analyzer is manufactured and tested according to International Standard
IEC 61010-1, "Safety requirements for electrical equipment for measurement, control and laboratory
use, Part 1: General requirements". This International Standard is equivalent to the national standards
Underwriters Laboratories (UL) 61010-1 for the USA, CSA CSA 22.2 No. 61010-1-4 for Canada.
Compliance is demonstrated by the following marks:
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the USA.

1.4 System Label
1.4.1 Disk System
Figure 1.4-1

Figure 1.4-2

1.4.2 Rack System
Figure 1.4-3

Figure 1.4-4

2.1 Site Requirements
2.1.1 Delivery Space Requirements
2.1.1.1 Receiving
A loading dock or other suitable facility is needed to allow the analyzer to be safely unloaded.
2.1.1.2 Routing
It is necessary to move the analyzer safely from the unloading point to the proposed point of operation.
Following spaces are required:
• Minimum door width is 91 cm or more (36 in. or more).
• Loading size & capacity of elevator, if required, are 135 cm x 91 cm (54 in x 36 in) or more and
207 kg (595 lbs).
• Minimum turning radius is 163 cm (65 in).
Note: The size and weight in the packing of e411 are as following
Table 2.1-1
LxWxH Weight
Packed e411(main body only) 135 x 91 x 86 cm (54 x 36 x 34 207 kg (595 lbs)
in)
Packed Rack Sampler 110 x 82 x 60 cm (44 x 33 x 24 69 kg (152 lbs)
in)
2.1.2 Physical Space and weighs Requirements

To install the cobas e411 analyzer, you are required to provide:
• A firm table and floor that is level and solid enough to bear the weight of the instrument.
The disk system weighs approximately 180 kg (397 lbs).

The rack system weighs approximately 250 kg (551 lbs).
• Adequate space around the instrument for ventilation, maintenance and easy access to power
inlets:
For the disk system, allow at least 100 cm (39.3 in) on the front,
10 cm (3.9 in) on the rear
50 cm (19.6 in) on the right side,
and 10 cm (3.9 in) on the left side of the instrument.
For the rack system, allow at least 100 cm (39.3 in) on the front,
10 cm (3.9 in) on the rear,
50 cm (19.6 in) on the right side,
and 50 cm (19.6 in) on the left side of the instrument.
Note: Please refer to Figure 2.1-1.

2.1.2.1 Installation diagram
Figure 2.1-1

• An appropriate grounding system
The installation site must have a grounding system with less than 10 ohms of resistance.
Grounding
Figure 2.1-2
2.1.3 Ambient Condition Requirements

See Chapter 1.2.1 Technical Data for Operation of Instrument
2.1.4 Electrical Requirements

2.1.5 Water Requirements


2.2 Inventory
Note: The current Inventory List is packed with the instrument. Please check the parts according to
this list when unpacking the instrument.
Please see the list below as example.

741-0050 : IMMUNOASSY SYSTEM cobas e411(FOR RDG/RDC)
741-0051 : IMMUNOASSY SYSTEM cobas e411(R/S SYSTEM FOR RDG/RDC)
741-8650 : e411ACCESSORY PARTS
Figure 2.2-1

Figure 2.2-2

Figure 2.2-3

2.3 Analyzer Installation
General
Installation is performed by an engineer of Roche Diagnostics representative.

When installing the cobas e411 we highly recommend that you follow the instructions in this Chapter.
2.3.1 Unpacking
• Make sure that the counter on which you will set the instrument satisfies the set up requirements.
Refer to Chapter 2.1.
• Unpack the cobas e411, and make sure that all accessories are in the box. Refer to the Inventory
list packed with the instrument.
• After complete unpacking of the instrument, remove all the safety devices from bead mixer,
pipetter, gripper, sipper, magnet drive and liquid waste container. See Figure 2.3-13 to Figure 2.3-
20.
• Check if there is any transport damage and please report details in case of transport damaged via
Roche Diagnostics GmbH to Hitachi High-Technologies Corporation..
• Place the plate (P/N 741-1770) on the counter top under the cobas e411 and verify that all the feet
of the cobas e411 are on the plate.
• Please refer the notice sheet to install the system that attached in the box. (See the next page)
Figure 2.3-1

Figure 2.3-2 Notice Sheet

Figure 2.3-3 Notice Sheet
Note: We offer a special table (Systable) on which to place the system, on stock.
Note: A side extension can also be ordered for Rack instruments.

When you move or lift up the instrument by using your hands, lift it by using the 4 points hand
positions indicated in following position.
Figure 2.3-4 General view of the instrument
Figure 2.3-5 Expansion of a part
Figure 2.3-6 Hand positions

• Place the two rubber plates (P/N 741-1760) under the front two leveling feet.
Figure 2.3-7
• Please match stability with a level.

• Please confirm that an analyzer is stable enough.

When you move or lift up the Rack system by using your hands, lift it by using the 4 points hand
positions indicated in following position.
Figure 2.3-8 General view of the Rack system
Figure 2.3-9 left side from the front
Figure 2.3-10 right side from the front

Figure 2.3-11 Expansion of a part
Figure 2.3-12
• Please match stability with a level.

• Please confirm that a rack syastem is stable enough.

2.3.2 Explanation of Packaging Position in the System

The arrangement of the parts and packaging is shown in the following figures
Figure 2.3-13
1 741-0119 BEADS MIXER ASSY

2 741-0302 WATER RESERVOIR ASSY
3 741-1510 L WATER TANK
4 741-0627 R DISK ASSY
5 741-0117 S DISK ASSY

2.3.2.1 Packing of S Disk Assy

The S Disk Assy is held with a cushion and fixed with a tape at one position.
Figure 2.3-14
1 741-0117 S Disk Assy

2 Cushion
3 Tape
Figure 2.3-15
1 Tape
2 Cushion
3 741-0117 S Disk Assy

2.3.2.2 Packing of R Disk Assy

The R Disk Assy is fixed with tapes at two positions.
Figure 2.3-16
1 Tape
2 741-0627 R Disk Assay

2.3.2.3 Packing of L Waste Tank

The L Waste Tank is held with a cushion and fixed with a tape at one position.
Figure 2.3-17
1 741-1510 L Waste Tank

2 Cushion
3 Tape

2.3.2.4 Packing of Water Reservoir Assy

The connection part of Buffer Tank Assy and Water Reservoir Assy is covered with a vinyl resin bag.
A cushion is placed on the Buffer Tank Assy, and the Water Reservoir Assy is placed on it; they are
fixed with a tape at one position. Water Reservoir Assy is placed so that the lid is on the front side.
Figure 2.3-18
1 Lid
2 Tape
3 741-0302 Water Reservoir Assy
4 Vinyl resin bag
5 741-0561 Buffer Tank Assy

2.3.2.5 Packing of Beads Mixer Assy

The Beads Mixer Assy is held with a cushion, and fixed with tapes at two positions.
Figure 2.3-19
1 741-0119 Beads Mixer Assy

2 Cushion
3 Tapes
4 Tape
Note: The mixing paddle (P/N741-0516) is detached from the head of beads mixer and is packed
with two (2) hex screws in a box together with the accessory parts.

2.3.2.6 Packing of R/S Cover
Figure 2.3-20
1 Tape

2.3.3 Panel PC Installation and confirmation of AC Power Supply

Please follow this procedure to attach the Panel PC to the instrument..
Follow this procedure to attach the Panel PC to the instrument.

1 ► Take out the main instrument body and Panel PC from the packing box.
Figure 2.3-21 Mooting position for PC
Figure 2.3-22 Front view of the panel PC
2 ► Attach the Panel PC to the instrument as shown in Figure 3 and 4. First, fold the BASE
PLATE and insert the Hook part to the main unit body and then, using three screws, fix the
PC in the three points indicated in the figure below.

Figure 2.3-23 General view of the installment
Figure 2.3-24 Screw positions
Figure 2.3-25 Cap positions

3 ► As shown in Figure 2.3-25, route the PC wires through the cramp on the back of the Panel
PC. Finally, connect the wires to the Panel PC as shown in Figure 2.3-26.
Figure 2.3-26 Wiring through cramp
Figure 2.3-27 Wire connection
4 ► Connect AC power cable
ο Make sure that the AC power voltage is between 100 and 240 V.
ο Make sure capacity of AC breaker at customer.
ο Refer to chapter 1.2.1 Technical Data for Operation of Instrument in detail.
ο Please follow this procedure to connect power cables.
ο Refer to chapter 1.1.7 Power Components.
Circuit Breaker
• Make sure that circuit breaker is “OFF” as shown in below.

• Please connect AC cable as shown in below.

Figure 2.3-28
Rack Circuit Breaker
• Make sure that circuit breaker is “OFF” as shown in below.

• Please connect AC cable as shown in below.
Figure 2.3-29
Attention
When PLUG / UNPLUG Connector for HOST, turn off the Circuit Breaker of instrument.
If PLUG / UNPLUG Connector for HOST with turn on the Circuit Breaker, not only e411 main unit but
also External Host may be damaged.

2.3.4 Setup
For Rack system, first refer to Chapter 2.5.1.
Mount the following items on the instrument.
• Reagent disk, sample disk

• Liquid waste container (empty)
• System water container filled with system water (Max. 3.0 L).
• Solid Waste Tray with a CleanLiner.
• Two sets of system reagent ProCell/CleanCell bottles.
• Three tip trays and three Assaycup trays on a magazine tray.
Check the following items before you switch the instrument on.
• S/R probe and Sipper probe are attached straight and vertically.
• Mixer paddle is attached straight and tightly to the part of Bead Mixer.
• Please never put an irrelevant thing on a instrument.
• Sample disk, reagent disk, Assay cup trays/Tip trays and system reagents.
• Solid Waste Tray with a CleanLiner is attached correctly to the container.
• Liquid waste container is mounted correctly.
2.3.5 Mounting a Measuring Cell

• Unpack Reference Electrode (RE) and Cell Body.
• Uncap the reference electrode and verify that there are the O ring at the junction of MC.
• Soak a reference electrode in distilled water during about 30 minutes
• Shake the reference electrode vigorously about 10 times to wet the ceramic junction.
• Tap the reference electrode gently on a hard surface.
• Attach the reference electrode into the cell body by screwing firmly.
• Mount the measuring cell (for mechanical details and mounting description refer to Chapter
4.4.13.3, using the two screws that taped to the bottom of the Detection unit.
• Attach the inlet/outlet tube for MC.
• Connect a connector (J610). Make sure that the cable cannot be jammed between the MC body
and the magnet arm by placing the cable across the reference electrode.

2.3.6 Installation of System Software

Install current system software (use only original software package, released by Roche Diagnostics
GmbH) even if a software version has already been installed on the system.
Refer to Chapter 2.4 Software Installation.
2.3.7 Fill Liquid System

Note: If water is not rinsed after the start of the priming function, the pump may run in air. To
remove this air, detach the pipe from the main pump (located on the right side below drain
cover). Make sure that no bubbles are left in the syringes or tube after priming function.
2.3.7.1 Pipetter/Sipper Priming

Make sure that the instrument is in standby status.
Concerning pipetter priming/sipper priming, refer to Chapter 6.2 Maintenance.
Carry out pipetter priming until water comes out of the pipetter probe.
Carry out sipper priming until water comes out of the sipper probe.
2.3.7.2 Beads Mixing

Concerning beads mixing, refer to Chapter 6.3 Mechanism Check.
Carry out beads mixing mechanism check until the bead mixer wash station fills with water.
2.3.8 Adjustments to be Checked During Installation and After

Replacement
Refer to Chapter 2.6 for adjustments to be checked during installation for Disk and Rack System and
confirm the positions described.

2.3.9 Measuring Cell Preparation

Introduction of MC
All measuring cells (MC) have been checked by HHT.
For storage and transportation, the MCs are dried again after having been checked at HHT.
The reference electrodes (RE) are packed with the MCs. To prepare the measuring cell the two
components have to be treated as follows to ensure good measuring results.
2.3.9.1 Preparation
Place the system reagent bottles in the appropriate positions.
Place two sets of system reagent ProCell/CleanCell bottles filled with
ProCell/CleanCell at Position 1 and Position 2.
Make sure the liquid waste container is empty.
Fill the system water container with system water (max. 3.0 liters).
2.3.9.2 Procedure of MC Preparation

Touch the [Utility] [Maintenance] [Measuring Cell Preparation] button in the Main screen.
Having touched the button in the screen, you will see a popup.
Input the number of repetitions in the screen. The number of cycles depends on the type of MC.
Input 30 under the present conditions, and please carry out.
Touch the START button in the screen.

2.3.10 System Volume Check
2.3.10.1 Preparation
• Place the system reagent bottles in the appropriate positions.
• Place two sets of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell at
Position 1 and Position 2.
• Make sure the liquid waste container is empty.
• Fill the system water container with system water (max. 3.0 liters).
2.3.10.2 Procedure
• Make sure that the instrument is in standby status.
• Touch the [Utility] [Maintenance] [Check] [System Volume Check] button in the Main screen.
• Touch the START button in the screen.
The system volume will be determined (for details refer to Chapter 3.4).
Note: After the procedure has been finished successfully, the status of instrument returns to Stand-
By. When alarm message occurred, check the liquid flow path (sipper side) for possible
leakage.
2.3.11 High Voltage Check/Adjustment
Introduction
Each MC in combination with a PMT represents a complete detection unit, which has to be adjusted
correctly. The high voltage adjustment should be carried out after measuring cell preparation to obtain
initial information about the instrument signal level.
The high voltage value has been adjusted initially in the quality control department at Hitachi in the
course of checks on the instrument, but not for some MC/PMT combinations. With the high voltage
adjustment (check) the field engineer should make sure that the combination of instrument
(photomultiplier tube, electronic components) and measuring cell work in the expected signal range.
If the signal is not in the required range, the photomultiplier tube (PMT) voltage has to be adjusted to
make the signal levels comparable between the different instruments. BlankCell reagent is used to
check the signal level (refer also to Chapter 6, Assay performance explanation, for more details).
Note: The [PMT high voltage adjustment] run only checks the current signal level of instrument
Calibrator BlankCell reagent. The high voltage adjustment to the correct signal range then
has to be carried out manually by the field engineer.
Figure 2.3-30

Figure 2.3-31 Assay Performance Check screen
2.3.11.1 Preparations
1 ► Place system reagent bottles in the appropriate positions.
2 ► Place the BlankCell reagent pack as shown below:
Table 2.3-1
Reagent rotor
RackPack Beads R1 R2
Pos. No.
2 BlankCell BCR1 BCR2 -
set
3 ► Sample arrangement
Table 2.3-2 For Disk System:

Cup in rotor
Run Liquid
pos.
PMT High Voltage Stop BC in –
Adjustment Pos. 4
Table 2.3-3 For Rack Sampler (R/S):
Racks in A Cup in rack
Run Liquid
line pos.
PMT High Voltage 1 1, 2, 3 –
Adjustment
► Use Hitachi normal sample cups.
► Remove all tips and cups from the incubator and the buffer plate.
► Place a full magazine with tips and cups in the front position on the tray.
2.3.11.2 Check Procedure

• Select [PMT HV adjustment] in the [Assay Performance Check] screen (Figure 2.3-32).

• Start the measurement by pressing the start button in the popup.
Figure 2.3-32 Popup screen of PMT High Voltage Adjustment
2.3.11.3 Evaluation of the PMT HV Adjustment Run

• Check the result in the [PMT High Voltage adjustment] popup after the run has finished (Figure
2.3-33).

Figure 2.3-33 Result screen of PMT High Voltage Adjustment
• Calculate the mean value of the BCR2 effective signals from the Result screen.
• Note the target value from the package insert of the BlankCell lot used.
• Compare the mean value of the BCR2 counts with the target. It should be in the range of ± 5% of
the target value.
Over time, the BCR2 level should be in the range of ± 10% (refer to Maintenance).
• If the current mean is outside the range, you may readjust the high voltage (refer to 2.3.11.5).
Note: We highly recommend that the high voltage is not changed in the first step if the signal level
of the BCR2 mean is outside the range of ± 7% of the target value.
First of all, the measuring cell preparation should be extended by another 30 or 50

measuring cell preparation cycles (refer to Chapter 2.3.9). In the second step make
sure that the measuring cell is mounted properly and that the BlankCell reagent is
O.K. Refer also to Chapters Troubleshooting of Assay Performance Check
The second row of values in the Result popup shows the dark level of the photomultiplier
tube. The dark level should be between 625 and 635 counts.

2.3.11.4 Restore Parameter

Carry out "RESTORE PARAMETER" after you have performed or even selected any assay
performance check (APC).
Select the [Restore Parameter] button in the [Assay Performance] check screen if you have finished
the assay performance section. You do not need to restore if you want to perform another APC run.
2.3.11.5 Adjustment of High Voltage

• Note the current high voltage by measuring the control voltage signal (CVS) between TP1 (GND)
and TP2 (CVS) on the PMT-SHV PCB (refer to Chapter 5.4.13 for details).
• Calculate the corresponding high voltage using the formula:
Figure 2.3-34
• Calculate the new PMT HV voltage using the following formula.
Figure 2.3-35
Vnew: PMT HV voltage that will be applied after measurement.
Vold: PMT HV voltage that was applied previously. (See the PMT HV record
label on the PMT SHV cover).
BCR2 Target: BCR2 value specified by RD.
• Calculate the new control voltage relative to the PMT HV voltage using the following formula.
Figure 2.3-36
• Adjust the voltage between TP1 (GND) and TP2 (control voltage signal) by changing the
resistance of the corresponding variable resistor (VR1, VR2 or VR3) according to the calculated
control voltage. The resistor is chosen by the jumper setting of JP1 (Pos.1, 2 or 3; refer to Chapter
5.4.13 for details).
• If the new high voltage value is outside the selected range you have to change the setting of
JP1then repeat the procedure, return to 2.3.11.2
• If the new high voltage value is the O.K., change the PMT HV record (the label is on the PMT SHV
cover).
Note: In case of problems make sure that LED1 located on the PMT-SHV2 PCB is lit. Check
connection J400.
Hint: A simplified calculation for determining the new High Voltage is shown in the example below.
Comment:On the high voltage side (HV voltage)

1 V ≈ 1000 counts
On the low voltage side (control voltage)

0.005 V ≈ 1000 counts
Example:
To change the BRC2 count result from 100,000 to 105,000 counts (ca. 5000 counts difference), the
HV voltage has to be increased by 5 V (+5 V ≈ 5000 counts difference). To adjust the value, change
the control voltage by + 0.025 V ≈ 5000 counts.

2.3.11.6 Adjustment of HV in Practice

• Select [PMT HV adjustment] in the [Assay Performance Check] screen.
• Start the program by pressing the [start] button in the popup window.
• Select the [Data Review] screen, the values of 20 determinations is shown in real time. Increase
the sequence No. after 7 determination to display the next results.
• Carry out the adjustment by turning the corresponding variable resistor during the run. Turn
clockwise for decreasing and counter clockwise for increasing the signal.
• The values (BCR2) should be in the range of ± 5% of the target value. The target value from the
BlankCell is written on the package insert.
• After the determination press the [Stop] button to switch the instrument from the Operation to the
Stand by mode.
• Carry out [Restore Parameter] after you have performed the HV adjustment.
Figure 2.3-37 Test Review Screen

2.3.12 Initial BlankCell Calibrations
Introduction
After the measuring cell has been prepared and it has been checked that the signal level is in the
expected signal range by means of the high voltage adjustment, the initial BlankCell calibration has to
be performed. The instruments are calibrated to give the same homogeneous signal level.
The initial BlankCell measurement is the first calibration done on the instrument before other assays
can be calibrated. Each measured signal will first be BlankCell-corrected (parameters a (intercept) and
b (slope)). The corresponding concentration is then read from the specific assay calibration.
• Initial Calibration
Determine factors (a) and (b)
Figure 2.3-38
2.3.12.1 Concept of BlankCell Calibration

• Target values of BlankCell R1 and R2, measured in the standardization department, are stored in
the barcode.
• Three determinations of BlankCell R1 and R2 are measured and the medians of BlankCell R1 and
R2 are calculated.
• Calculation of the BlankCell correction parameters
Calculation of BlankCell correction parameters - factors a and b:
Figure 2.3-39
Each calibrator, control and sample signal measured is corrected by the BlankCell correction
parameters as shown below.
Figure 2.3-40

2.3.12.2 Preparation
1 ► Place BlankCell reagent pack in reagent rotor .
Table 2.3-4
Reagent
rotor RackPac
Beads R1 R2
k
Pos. no.
in any BlankCell BCR1 BCR2 -
position set
2 ► Sample arrangement
Note: Samples need not be placed to perform Initial BlankCell.

1 ► After boot up the e411 or Logoff the e411, a pop-up window appears as shown in Figure
2.3-41. The Operation ID and Password are following.
Operator ID : bmserv
Password : nakakojo
Figure 2.3-41 Logon window
2 ► Select Initial Blank Cell Calibration item in the Service screen

3 ► Set to “ON” on Blank Set Option
Note: if you want to measure “Initial Blank Cell Calibration”, you must set the ”ON” button.
Otherwise e411 will measure “Blank Cell Calibration”

Figure 2.3-42 Initial Blank Cell Calibration screen
4 ► Start Reagent Scan (Reagent Screen )

5 ► After the scan the BLANK CELL is requested by the instrument.
6 ► Press the Start button.
7 ► After the Blank Cell procedure has finished, check the printout of the results carefully. The
quality criteria should look the same as in the specimen printout. See attached printout of
successful Initial Blank Cell (specimen).

Figure 2.3-43 Example for printout :
8 ► It is very important that the Initial Blank Cell is successful. If not, repeat the process until it is
successful, otherwise all results may not be corrected properly. Refer to Chapter 2.3.12.3
for current result targets. (If necessary start procedure once more. Go back to point 3.)
9 ► If the Initial Blank Cell was successful, remove the BLANK CELL RackPack. This is very
important, otherwise the instrument will do the periodic blank cell automatically.
10 ► Start Reagent scan.
2.3.12.4 Evaluation of Initial BlankCell

• Compare the mean value of the BCR1 (all values are on the printout) counts with the target. It
should be : BCR1 Target range 120 to 400 counts
• Check the slope value from Initial BlankCell screen: BCR2 Slope should be 1.0 ± 0.05 (=
parameter (b)).
• If one of the targets is outside these limits refer to the recommendations given and repeat the
procedure until the targets are reached.

2.3.13 Instrument Checks

Finally, we recommend that the Artificial Media Test and the TSH assay test are performed to check
the instrument performance. To perform the runs you need the Elecsys check reagents.
2.3.13.1 Artificial Media Test (AM Test)
Introduction
The Artificial Media Test is a button in the menu [Assay Performance Check] in the [Utility] screen. It is
a short instrument check and principally measures the same criteria as the RD internal instrument
check.
Homogeneous Determination
With homogeneous determination magnetic separation is not used. A solution of free label is
transported inside the measuring cell and the performance of the detection unit (MC/PMT) can be
analyzed. With equal height of BCR2 1:20, the performance of the pipetter side can be analyzed.
Heterogeneous Determination
The heterogeneous determination simulates an assay. The iSAP test uses beads and a biotinylated
and ruthenium-labeled antibody. An immuno-independent bead/antibody complex is generated to
analyze the detection unit, measuring cell and magnet function.
If all performance data for the homogenous determination are in order, then disturbance in the
heterogeneous determination can only be caused by the liquid flow system (tubing/fittings, connectors,
sipper),the magnet or the MC
BCR1, BCR2 and BCR2 1:20 are homogeneous, ProCell, iSAP and TSH are heterogeneous.
The test takes about 45 min.
Table 2.3-5 Materials Required

RackPack name Amount Material No.
BlankCell 2 1729306-122
CellCheck 2 1820451-122
SAP 1 1820435-122
Table 2.3-6 Samples Required
Sample name Amount
ProCell 7 ml
BCR2 1 ml
Preparations
Place system reagent bottles in the appropriate positions.

Set reagent rack packs in reagent disk positions 1 to 5 as follows:
Table 2.3-7
Pos. No. RackPack Beads R1 R2
1 BlankCell set BCR1 BCR2 -
3 CellCheck ProCell ProCell ProCell

Pos. No. RackPack Beads R1 R2

5 SAP test Beads Buffer FC
Sample arrangement
For Disk System:
Table 2.3-8
Run Cup in Rotor pos. Liquid
Artificial Media Check. 3 BCR2 (1 ml)
4 to 10 ProCell (1 ml)
Use Hitachi normal sample cups.

Pipette 1 ml of BCR2 into sample disk position 3 and 1 ml of ProCell into each sample disk position
from 4 to 10.
Place a stop Bar code in Pos. 11.
Remove all tips and cups from the incubator and the buffer plate.
Place a full magazine with tips and cups in the front position on the tray.
For Rack Sampler:
To perform the AM test with the R/S you need at least two racks.
Table 2.3-9
Run Rack in A line No. Cup in rack pos. Liquid
Artificial Media Check 1 1, 2 Empty cups
3 BCR2 (1 ml)
4, 5 ProCell (1 ml)
2 1 to 5 ProCell (1 ml)
Use Hitachi normal sample cups.

Pipette 1 ml of BCR2 into rack no. 1 position and 3, 1 ml of ProCell into rack 1 positions 4 and 5 and
rack 2 positions 1 to 5.
Check Procedure
For Disk System:
After touching the [Artificial Media Test] button in the [Assay Performance Check] screen, start the
measurement by pressing the start button.
For Rack Sampler:
On the rack sampler simply place rack 1 and rack 2 in the A line and start the [Artificial media test]
button in the [Assay Performance Check] screen.

Artificial Media (AM) Test parameters
Table 2.3-10
R. Disk
Reagent Assay Assay parameters
Pos. No.
1 BlankCell BCR1 Assay protocol 24
Incubation time [cycles] i1 1
i2 1
Pipetting volume [µL] R1 200
R2 0
B 0
S 0
Detection Cycle Check
2 BlankCell BCR2 Assay protocol 26
i2 1
R2 200
B 0
S 0
3 CellCheck BCR2-D Assay protocol 0
i2 1
R2 95
B 0
S 10
4 CellCheck AB3 Assay protocol 2
i2 13
R2 100
B 0
S 0
Detection Cycle Normal
5 iSAP iSAP Assay protocol 2
i2 13
R2 60
B 35
S 0
Test items performed by the artificial media check
Table 2.3-11
For For
Rack Disk
Pos. Pos. Sampl Item 1 Item 2 Item 3 Item 4 Item 5 Item 6 Item 7 Item 8 Item 9 Item
No. No. e 10
1 1 - BCR1 BCR1 BCR1 BCR1 BCR1
2 2 - BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2
3 3 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2 BCR2
-D -D -D -D -D -D -D -D -D -D
Rack Rack 1
4 4 ProCell AB3 AB3 AB3 AB3 AB3

5 5 ProCell iSAP
1 6 ProCell AB3
(CO)
2

For For
Rack Disk
2 7 ProCell iSAP
3 8 ProCell AB3
(CO)
4 9 ProCell iSAP
5 10 ProCell AB3
(CO)
Evaluation of the AM Test
The instrument can automatically calculate the results.

Press the [Print result] button in the [Assay performance] screen.
To evaluate the results use the parameters and acceptable ranges for the artificial media test given in
the table.
(For target values refer to table Table 2.3-13 “APC test; Targets, AM test”).
If troubleshooting is necessary refer to the charts given in 2.3.13.3.
Note: If a result is missing, the mean and CV are calculated wrongly. In such cases calculate the
corresponding result manually with the formulas given in Calculation Formulas
• The BCR (BlankCell reagent) target value should be reached; this is used for the instrument
calibration. The determination of BCR1 means the lower, BCR2 the higher calibration value. This
reflects the recovery and the variance of the target value.
Note: None of the measured counts with tests from the Assay Performance Checks are connected
with the instrument calibration factor.
• BCR2 is used to adjust the PMT-HV and indicates problems with the PMT and excitation.
• BCR2-D is a dilution of BCR2 with BCR1 and shows the functionality of the pipetter, the pipetter
precision and general problems with the liquid handling.
• AB3(CO) is determined using the measuring cycle for heterogeneous assays. These values are
the basic values used for calculating carryover.
• iSAP is a model assay based on streptavidin beads. iSAP facilitates the evaluation of the
complete LFS (liquid flow, magnet, capturing, detection) in a routine assay.
• Carryover is the measurable influence on the assay performance and is the consequence of
carryover of beads into the measuring cell in this case.
Calculation Formulas
cobas e411 instrument in which all items listed in list below meet the criteria passes Assay
Performance Check.
• The normalization of items is carried out with BCR2 measured value
Figure 2.3-44
• BCR2 target value, concentration values for TSH Cal1and Cal2, and LO factor (LOF) are provided
for each lot by RD.
• LOF is defined as ratio: (tangent new rackpack lot) / (tangent frozen reference lot) That factor is
corrected by the typical coefficient of reagent aging on a monthly base. That typical coefficient of
reagent aging is calculated as the median monthly decay over several lots. LOF and its aging
forecast are transferred from RD.
Table 2.3-12 Please Enter a Table Caption

Item Calculation
BCR1/ Average
BCR2N
BCR2 Average average of 10 values of BCR2 [counts]

CV CV of 10 values of BCR2
BCR2(1:20) CV CV of 10 values of BCR2-D
iSAP/ Average
BCR2N
Figure 2.3-45
Carry over (CO)
Figure 2.3-46
Restore Parameter
Select the [Restore Parameter] button in the [Assay Performance Check] screen if you have finished
the Assay performance section. You do not need to restore if you want to perform another APC run.
Table 2.3-13 APC Tests; Targets (AM test)

No. Parameter Unit Range
1 BCR1 signal average [ counts ] 120 - 400
2 BCR2 signal average [ counts ] Target ± 10%
3 BCR2 precision [ CV ] ≤ 2.0% cobas e411
4 BCR2 –Dil (1:20) precision [ CV ] ≤ 2.5%
5 iSAP/BCR2N [ counts ] 0.85 to 1,3 Mio
6 Carry over ( CO ) [ ppm ] ≤ 90
Instrument released, if all values are in the range.
2.3.13.2 TSH Assay Test

TSH assay (heterogeneous determination) is a button in the menu [assay performance check]. Unlike
to the artificial media test, the customer as a matter of routine performs this immunoassay.
The TSH assay is a necessary service tool as it reveals problems in the assay performance that occur
in determinations where high dynamic, very low LDL (lower detection limit) and very high precision are
required. For instrument/instrument performance criteria we have to use more detailed checks. There,
the calibration also plays a role.
The test takes about 45 min.
Table 2.3-14 Materials required

Rack pack name Amount Material No.
TSH 1 1731459-122
CellCheck 1 1820451-122
Table 2.3-15 Required samples:
Sample name Amount Material No.
ProCell 1 ml
TSH Cal 1 650 µl 1731483-122
TSH Cal 2 400 µl 1731483-122

Preparations:
Set reagent racks for TSH assay test in reagent disk positions 6 and 7.
Table 2.3-16
Pos. No. RackPack Beads Reagent 1 Reagent 2
7 TSH Beads R01 R02
Sample arrangement
For Disk-System:
Table 2.3-17
Run Cup in rotor pos. Liquid
TSH assay test 15 ProCell (1 ml)
16 TSH Cal1
17 TSH Cal2
Use Hitachi normal cups and RD calibrator vials.
For Rack Sampler:
Table 2.3-18
Run Rack in A line No. Cup in rack pos. Liquid
TSH assay test 1 1 ProCell (1 ml)
2 TSH Cal1
3 TSH Cal2
Use Hitachi normal cups and RD calibrator vials.
Check Procedure
For Disk System:
After touching the [TSH assay test] button in the [Assay Performance Check] screen, start the
measurement by pressing the start button
For Rack Sampler:
On the rack sampler simply place rack 1 in the A line and start the TSH test by pressing the [TSH
assay test] button in the [Assay Performance Check] screen.

TSH Assay Test parameters
Table 2.3-19
R. Disk
Reagent Assay Assay parameters
Pos. No.
6 CellCheck AB2 Assay protocol 2
i2 12
R2 50
B 40
S 50
7 TSH TSH Assay protocol 2
i2 12
R2 50
B 40
S 50
Test items performed by the TSH assay test
Table 2.3-20
Pos. Item
Sample Item 1 Item 2 Item 3 Item 4 Item 5 Item 6 Item 7 Item 8 Item 9
No. 10
1/15 ProCell AB2 AB2 AB2
2/16 TSH TSH TSH TSH TSH TSH TSH TSH TSH TSH TSH
Cal1
3/17 TSH TSH TSH TSH TSH TSH
Cal2
2.3.13.3 Evaluation of the TSH Assay Test

The instrument can automatically calculate the results.
Press the [Print result] button in the [Assay performance check] screen.
To evaluate the results use the parameters and acceptable ranges for the TSH assay test given in
Table 2.3-21 on the next page (APC tests; Targets, TSH test)
If troubleshooting is necessary refer to the charts in 2.3.13.3.
Note: If a result is missing, the mean and CV are calculated wrongly. In such cases calculate the
corresponding result manually using the formulas given in Test items performed by the TSH
assay test
The tangent (TSH Cal2) describes concentration-independent dynamics. A tangent value

outside target indicates problems with the measuring cell, LFS and MC or the magnet.
The LDL (lower detection limit) is the lowest value that differs significantly from the
concentration of 0 µU/ml. Dynamics and precision in the lower range influence the LDL.
Apart from problems with the measuring cell, the pipetter or the magnet, problems with
the sipper, liquid handling and liquid flow ( tubing, foam, bubbles ) and temperature
influences increase the LDL, i.e. give poorer assay performance.
An increased first value of the TSH Cal1 (TSH Cal1 1st value high) is seen in the event of
a preceding homogeneous determination (e.g. ProCell, Prepare, Idle). In most cases it is
related to the performance of the measuring cell. A high first value is only observed if a
ProCell/Prepare cycle is run before a very low signal in a heterogeneous determination.

2.3.13.4 Calculation Formulas

Cal1/ Average
BCR2
N
Figure 2.3-47
CV CV of 10 values of TSH Cal1
Cal2 CV CV of 5 values of TSH Cal2
Tangent
Figure 2.3-48
Cal1 first
value high (FVH)
Figure 2.3-49
Low Detection
Limit (LDL)
Figure 2.3-50

Select the [Restore Parameter] button in the [Assay Performance check] screen if you have finished
the Assay performance section. You do not need to restore if you want to perform another APC run.
Table 2.3-21 APC tests, Targets (TSH test)

No. Parameter Unit Range
1 Cal1/BCR2N [counts] ≤ 1300
2 TSH Cal 1 precision [CV] ≤ 4.0%
3 TSH Cal 2 precision [CV] ≤ 2.0% cobas e411
4 Lower detection limit (LDL) [µU/ml] ≤ 0.005
5 Tangent TSH Cal2 [counts] ≥ 12 000
6 Cal 1 first value high [counts] ≤ +8.0%
Instrument released, if all values are in the range.

2.3.13.6 Assay Performance Check Troubleshooting
Flow Diagram
Figure 2.3-51
Legend
CV = Coefficient of Variation HW = Hardware
MC = Measuring Cell BCR = BlankCell Reagent
RE = Reference Electrode PMT = Photomultiplier Tube
HV = High Voltage LF(C) = Liquid Flow (Cleaning)
LFS = Liquid Flow System LH = Liquid Handling

Figure 2.3-52
Legend
SAP = Special service reagent TSH = Thyroid-specific Hormone
MC = Measuring Cell RE = Reference Electrode
PMT = Photomultiplier Tube HV = High Voltage
LF(C) = Liquid Flow (Cleaning) LFS = Liquid Flow System
LH = Liquid Handling BCR = Blank Cell Reagent

Figure 2.3-53
Legend
SAP = Special service reagent TSH = Thyroid-specific Hormone
MC = Measuring Cell BCR = Blank Cell Reagent
LFC = Liquid Flow Cleaning LFS = Liquid Flow System
LH = Liquid Handling
Troubleshooting of Assay Performance Check
Table 2.3-22
Check items Phenomenon Possible cause Remedy
PMT HV Signal≅0, 1. HV connector is not 1.Confirm the following connections:
adjustment DL=625 connected
• between P400 and J400 on PMT-SHV board.
2.PMT connector is not
connected.
• between P401 and J401 on PMT-SHV board.
• between P610 and J610 in Detection Unit.
2.Others, refer to the Cross Wiring Diagrams for details.

3.Connector of L-Amp. Confirm the following connections:
board
is not connected. • between P430 and J430 on L-AMP board.
4.Shield plug is not
connected. • P/J431 on L-AMP board or P/J119 on EECL board.
5.PMT or L-Amp board Replace the PMT or L-Amp board.

is
to be defected.
6.Shield cable is open- Confirm the following connection.
circuited.
• between P430 and J430 on L-AMP board.
• P/J431 on L-AMP board or P/J119 on EECL board.
Signal≅0, 1.Measuring cell is not 1.Confirm no ADC alarm 31-02-01 or 31-02-02 takes


DL>625 mounted. place.
2.Connector of 2. Confirm the following connection:
measuring cell is not
connected. • between P610 and J610 in detection unit.
3.Liquid leakage occurs Check the sipper flow system.

in sipper flow system.
4.Liquid leakage occurs Check the pipetter flow system.
in pipetter flow system.
Signal<70,000, 1.Wrong reagent or 1.Confirm that the Reagent Lot is valid.
DL>625 reagent position. 2.Replace the reagent.
2.Measuring cell is not Confirm position of the measuring cell relative to PMT.
mounted correctly.
3.PMT is not mounted
correctly.
5.Liquid leakage occurs Check the pipetter flow system.
in pipetter flow system.
PMT HV Signal is not 1.Shading to the 1.Confirm the dark level value is lower than 640.
adjustment stable. detection unit is not 2.Confirm that the sponge lid between PMT and the plug
sufficient. P401 has not become detached.
2.Shield plug is not 1.Confirm the connection between P430 and J430 on L-
connected correctly. AMP board.
2. P/J431 on L-AMP Board or P/J119 on EECL board.
4.Temperature control Confirm temperature of the detection unit on the
of the detection unit is temperature monitor screen, refer to Chapter 6.
not sufficient.
AM test Normalized 1.Wrong reagent or 1.Confirm that the Reagent Lot is valid.
BCR1>400 reagent position. 2.Replace the reagent.
2. L-AMP board is Replace the L-AMP board.
defective.
3. Active bleeder is Replace the PMT.
defective.
BCR2 CV% >2% 1. System volume Perform system volume check.
check not done.
2. Liquid leakage occurs Check of the sipper flow system.
3. Number of MC Repeat MC preparation again at least 30 times as
preparations is not described in Chapter 2.
sufficient.
4. Measuring cell is Replace the measuring cell as described in Chapter 4.
defective.
BCR2(1:20) CV% 1. Liquid leakage occurs Check the pipetter flow system.
>5%, in
pipetter flow system.
2.Dust on pipetter probe Use gauze moistened with distilled water to clean the end
end. of the pipetter probe.
3.Height of pipetter Adjust the Z axis position of pipetter according to Chapter
probe, Z axis position is 4.
not correct.
Carryover >100 1. Liquid leakage occurs Check the sipper flow system.
ppm in sipper flow system.
2.Position of magnet Use the magnet drive tool, adjust the position by referring
relative to the to
Measuring cell is not Chapter 4.
sufficient.
3. Measuring cell is Replace the measuring cell as described in Chapter 4.
defective.
Sensitivity >6E- 1. Anode dark current of 1.Confirm the dark level value. If the value is more than
15W PMT is bigger than 640, leave the PMT in instrument standby status overnight.
usual value.
2.Shading to the 2. Confirm that the sponge lid between PMT and the plug
detection unit is not P401 has not become detached.
sufficient.
3. Number of MC Repeat MC preparation again at least 30 times as


preparations is not described in Chapter 2.
sufficient.
4.Measuring cell is Replace the measuring cell as described in Chapter 4.
defective.
TSH assay test Tangent <11000 1.Magnet itself is Confirm iSAP signal value. If the value is lower than 1.2E
Tangent/CAL defective. 6, replace the magnet or check position of magnet relative
1<10 to the measuring cell.
2.Temperature control Confirm temperature of the detection unit on the
of the detection unit is temperature monitor screen, refer to Chapter 6.
not sufficient.
3.Measuring cell is Replace the measuring cell as described in Chapter 4.
defective.
4.L-AMP board is Replace the L-AMP board.
defective.
CAL 2 CV% >2% 1. Liquid leakage Check the pipetter flow system.
LDL >0.005 occurs in pipetter flow
system.
2.Dust on pipetter probe Use gauze moistened with distilled water to clean the end
end. of the pipetter probe.
3.Height of pipetter Adjust the Z axis position of pipetter according to Chapter
probe, Z axis 4.
position is not correct.
CAL 1 signal Measuring cell is Replace the measuring cell as described in Chapter 4.
>1200 defective.
1st value >8%
2.3.14 Assay Calibration

After the procedures described above have been finished successfully, we recommend that the field
engineer carries out at least one or two assay calibrations.
To check the installation in routine some controls should be performed finally. We recommend running
PCU1/PCU2 for the TSH assay.
2.3.15 Installation Procedures Overview / Checklist

Note: You may copy the following table and use it as an installation checklist
Table 2.3-23
Refer to
Step Procedure DONE
chapter
1 Unpacking 2.3.1
2 PC installation and AC power supply confirmation 2.3.3
3 Setup 2.3.4
4 Mounting a measuring cell 2.3.5
5 Installation of system software 2.3.6; 2.4
6 Fill liquid system 2.3.7
7 Check important adjustments 2.6
8 Measuring cell preparation 2.3.9
9 System volume check 2.3.10
10 High voltage check/adjustment 2.3.11
11 Instrument checks 2.3.13, 2.3.13.1
-Artificial media check 2.3.13.2
-TSH assay test
12 Initial BlankCell calibration 2.3.12
13 Assay calibration 2.3.14
2.3.16 Procedure for Multiple Installations

In the event of multiple instrument installations, the following results should be compared.
Precondition: Individual results for AM, TSH and PCU1/PCU2 must be determined on the instruments.

Table 2.3-24
Refer to
Step Procedure Done
chapter
14 Instrument checks 2.3.13
-TSH assay test
• Targets as described in this chapter (Targets/Ranges of APC Tests).
• SAP signals and or Calset 1 and 2-signal difference should be max. 10%
between systems.
ο Change measuring cell and restart with point 8 if the signal difference is
not within the limits.
ο Change system and restart with point 1 if the signal difference is not
within limits after exchanging the measuring cell.
15 Carry out Assay Calibration for TSH and measure Precicontrol Universal as sample.
• Control concentration difference should be max. 5% between systems
ο Change measuring cell and restart with point 8 if the concentration

difference is not within the limits.
ο Change system and restart with point 1 if the concentration difference is

not within the limits after exchanging the measuring cell.

2.4 Software Installation
2.4.1 Application Instruction

It is described the specification of the installer that install a cobas e 411 system software to the
instrument.
The installer is offered by installation CD and copies a cobas e 411 system software file to a fixed
directory (CF memory).
Figure 2.4-1

2.4.1.1 Install function

The installation function executes the processing of the following each item one by one.
However, it can be executed by selecting the installation of a cobas e 411 application and the
installation of the multi national language file with the external definition file.
Figure 2.4-2
1 ► Logoff of e411 application. Push Logoff button and display Logoff dialog screen, then push
Shutdown button.

Figure 2.4-3
2 ► Switch on the Main Power

3 ► Close the cmd.exe when e411 system boot up. Push close button on cmd.exe screen.
Figure 2.4-4
4 ► Extracting the Application File

4.1 ► Connect the external media to a USB port on the left side of the analyzer.
4.2 ► Set CD include e411 application program in external media.
5 ► Select “Start -> My Computer”
Figure 2.4-5

6 ► Installation of e411 application program
This installation program doesn't have the difference between a new installation and the update.
6.1 ► Connect the DVD drive with the USB port.

6.2 ► Insert installation CD in the DVD drive, then the following screens are displayed.
Figure 2.4-6
When installing, it displays the dialog whether to initialize data. If select “YES”, it initializes data. If
select “NO”, the file in the data directory is not changed. When you select Yes or No and push “NEXT”,
the go to next screen. If you push “Cancel”, the installer is ended without processing anything.
Note) If you insert CD, and the above screen doesn't display, double-click E:\setup.exe from “My
Computer”(see “5)”).
6.3 ► Push “NEXT”, then the following screens are displayed.
Figure 2.4-7
You select whether to copy it to the directory for which the system software is specified with the
external definition file. When you select Yes or No and push “NEXT”, the go to next screen. If you
push “Cancel”, the installer is ended without processing anything.
6.4 ► Push “NEXT”, then the following screens are displayed.

Figure 2.4-8
You finally confirm the installation. When you copy the selected file to the preceding clause, push the
“OK” button. If you push “Cancel”, the installer is ended without processing anything.
6.5 ► Push “OK” and the installation ends, and then the following screens are displayed.
Figure 2.4-9
If the installation fails, the installation failure message is displayed and the installer is ended.
Figure 2.4-10
If you failed in the installation of the application, it is necessary to do over again from procedure 6.2 ►.
7 ► Shut down of PC and Main Power

7.1 ► Select Shut Down from Start menu and Switch off the Main Power
9 ► System Setup
9.1 ► Confirm the following items.
1. Confirm the Date and Time

2. Confirm the Software Version

3. Confirm the Check Sum of AU and PC
Figure 2.4-11
Refer to Chapter 6.1.3 System Setup for details.
2.4.2 Printer Driver Instruction

2 ► Close the cmd.exe when e411 system boot up
2.1 ► Push close button on cmd.exe screen.
Figure 2.4-12
3 ► Disabling the Write Protection

3.1 ► Select ControlPanel

Figure 2.4-13
3.2 ► Run “Drive Protect” (double click)
Figure 2.4-14
3.3 ► Select Setting tab and set password “1234” and uncheck “Protect ON”
Figure 2.4-15
3.4 ► Reboot

Figure 2.4-16
3.5 ► Select “No” after reboot.
Figure 2.4-17
4 ► Deleting Already-installed Printer Settings

4.1 ► Select Start -> Printers and Faxes.
Figure 2.4-18
4.2 ► If there are already-installed printers, select the file and then right-click on it, and select
“Delete” from the pop-up menu (or select File -> Delete).
Figure 2.4-19
4.3 ► When the following dialogs appear, touch the Yes button, and then the OK button.

Figure 2.4-20
Figure 2.4-21
5 ► Extracting the Driver File

5.1 ► Connect the external media to a USB port on the left side of the analyzer.
5.2 ► Start Explorer and see the contents of the external media. And double-touch the obtained
file, “lj1320PCL6win2kxp2003-en.exe”.
5.3 ► Follow the steps below to extract the contents to a default folder.
Figure 2.4-22
Figure 2.4-23
6 ► Installing the HP1320 Printer Driver

6.1 ► Connect the printer and turn the power on. And install the printer driver according to the
following procedure.
Note: This is a procedure for the HP1320 Printer Driver. If you use other Printer Driver defined by
the e411, the procedure will be shown in other Printer Driver.
6.2 ► When the following dialog appears, check the “Install from a list or specific location
(Advanced)” radio button. Then touch the Next button.

Figure 2.4-24
6.3 ► When the following dialog appears, check the “Don’t search. I will choose the driver to
install” radio button. Then touch the Next button.
Figure 2.4-25
6.4 ► Touch the Have Disk… button.
Touch Figure 2.4-26
6.5 ► When the following dialog appears, touch the Browse… button.

Figure 2.4-27
6.6 ► Select “C:/Program Files/Hewlett-Packard/LaserJet 1320 Drivers”, and touch the Open
button.
Select
Figure 2.4-28
6.7 ► Select “hpc1320c.inf”, and touch the Open button.
Figure 2.4-29
6.8 ► Touch the OK button.
Figure 2.4-30

6.9 ► Touch the Next button.
Figure 2.4-31
Touch
Figure 2.4-32
6.11 ► Select “C:/WINDOWS/system32”, and touch the Open button.
Figure 2.4-33
Figure 2.4-34

6.13 ► Select “C:/Program Files/Hewlett-Packard/LaserJet 1320 Drivers”, and touch the Open
button.
Figure 2.4-35
Figure 2.4-36
6.15 ► Touch the Finish button.

Figure 2.4-37
6.17 ► Select “C:/WINDOWS/system32” and touch the Open button.

Figure 2.4-38
Figure 2.4-39
6.19 ► If the following dialog appears, touch the Browse…” button.
Figure 2.4-40
6.20 ► Select “C:/Program Files/Hewlett-Packard/LaserJet 1320 Drivers” and touch the Open
button.

Select
Figure 2.4-41
Figure 2.4-42
6.22 ► Select Start -> Printers and Faxes, and check if the installation went successful.
Figure 2.4-43
This ends the procedure for installing the printer driver.
7 ► Enabling the Write Protection

7.1 ► Select ControlPanel

Figure 2.4-44
7.2 ► Run “Drive Protect”
Figure 2.4-45
7.3 ► Select Setting tab, and check “Protect ON”
Figure 2.4-46
7.4 ► Select “OK” after reboot.

Figure 2.4-47
8 ► Shut down of PC and Main Power

8.1 ► Select Shut Down from Start menu and Switch off the Main Power
10 ► Push “Print Screen” button
10.1 ► Confirm whether the device can be printed.
2.4.3 System Parameter Setup

After install, you need to set up the system parameter.
See Chapter 6.1.4.
Figure 2.4-48 Storage Utility Screen

2.5 Rack Sampler System Installation
2.5.1 Rack Sampler System Installation

∗ Procedures 3 to 5 are required for upgrading from the Disk System to the Rack Sampler When install the Rack
Sampler System, Procedures 3 to 5 are not required
1. Setting Up cobas e411

1) Preparing cobas e411 main unit: Figure 2.5-1
• Remove the rear cover.

• Remove the cover for gripper.
• Remove the R. lid.
• Remove the table cover L.
• Remove the front cover.
• Remove the S jacket assembly with the ground wire.
• Remove the S disk driving unit.
• Remove the side base.
• Connect a dummy connector to the connector from which the S disk driving unit has been
removed. (P510, P511)
2. Setting Up the Rack Sampler Unit
• Set the rack sampler unit in the position to be installed.

• Remove the loader cover (2 screws M4, top surface,2 screws M4, left side) : Figure 2.5-2
• Remove the sampler rear cover (2 screws M4, front surface, 2 screws M4, left side)
• Remove 3 bushes for fixing slide unit.
• Slide the base to the left by 160 mm, and fix it with 1 bush. : Figure 2.5-3
ο ! When sliding the base, be sure to hold the handle of the base to slide.
ο ! When mounting the bush, take care not to catch the wire.
• Remove the coupling plate. (2 screws M6, pan-head screws)
3. Adding PC Board, and Setting DIP Switches
• Remove the cover for PCB rack (P/N 741-4541).

• Remove all the connectors at the upper part of PCB rack.
• Remove the cover for circuit board (P/N 741-1583).
• Remove the EIO3 PC board (P/N 741-5080) from the PCB rack.
• Connect the RS CONT D PC board (P/N 741-5074) through spacer. : Figure 2.5-4
• Set the DIP switches on the RS CONT D PC board.
Set all the DSW2 to Off.
• Attach the EIO 3 PC board to which the RS CONT D PC board is attached to the PCB rack.
• Attach the cover for circuit board (P/N 741-1583).
4. Connecting Communication Cable: Figure 2.5-5
• Remove the DIST-F PC board (P/N 741-5028).

• Connect the communication cable to the J900 connector on the RS CONT D PC board.
• Change the nylon clamp (HP-5N ⇒ HP-10N), bundle the communication cable with the existing
cable.
• Connect the BRC cable to the J343 connector on the UIRS-C PC board (P/N741-5081) : Figure
2.5-5
• Pass the communication cable through the side hole of the cobas e411 main unit.
• Attach the connector of the upper part of PCB rack.
• Attach the cover for PCB rack (P/N 741-4541).
• Attach the DIST-F PC board.

5. Attaching BCR Assembly, and Connecting BCR Cable: Figure 2.5-5
• Attach the BCR assembly to the cobas e411 main unit.

• Attach the ground wire.
• Connect the BCR cable to the connector on the BCR PI PC board (P/N 741-5056).
• Refer to chapter 2.6.5.3 for the BCR adjustment.
6. Connecting Rack Sampler Unit to Main Unit
• Attach the coupling plate to the aluminum base of the cobas e411 main unit. (3 screws M5, pan
head screws).
• Put the communication cable between the main unit and the coupling plate.
• Connect the rack sampler unit to the cobas e411 main unit. : Figure 2.5-6
ο ! When connecting, make sure that the couple blocks meet each other so that there is no gap
between the “A” plane and “B” plane, and fix them with screws.
7. Wiring between Units
Connect the communication cable from the cobas e411 to the J908 connector on the rack sampler PC
board. Arrange wiring as shown in the figure, fasten the cable with clamps at five positions. : Figure
2.5-7
8. Fixing Rack Sampler Unit
• Remove the bush attached in procedure 2-5, slide the rack sampler unit onto the cobas e411 main
unit.
• Attach the 3 bushes removed in procedure 2-4, fix the unit.
9. Height Adjustment
• Loosen the lock nut of the adjuster (×2). Then, while checking levelness using a level gauge, turn
the adjuster to adjust the height as shown in Figure 2.5-8.
• When good levelness is obtained, tighten the lock nut to fix the adjuster.
10. Attaching Cover: Figure 2.5-7
• Attach the front cover and rear cover to the cobas e411 main unit.
• Attach the cover for rack sampler unit by following the procedure for removal in reverse (refer to
Procedure 2).
• Attach the Stat cover. (2 screws M4, top surface)
• Attach the screw lids to the rack sampler unit and cobas e411 main unit.
• Attach label. (Only if the cobas e411 main unit has a molded base.)
• Figure 2.5-9 shows dimensions.
Note: Be careful not to detach the photocoupler PI213 located at the Stat position from the plate of
the B line.
11. Adjusting Sampling Position (refer also to Chapter 2.6.5.2)
After turning on the power of the instrument, wait until it goes into Stand-by and perform the sampling
position adjustment by following the following procedures.
1 ► Fix the test tube guide with tape so that it stays open.
2 ► Press the B line Sampling Pos key on the adjustment rack.(Put 13mm diameter test tubes
onto the rack, and attach tip to P nozzle.) Check roughly how far the tip of the Tip is from the
center position of the container. : Figure 2.5-10
3 ► Loosen the sensor fixing screws (2 screws M4, 1 screw M3), shift the sensor fixing plate by
about the same distance as checked in 2 ►, and fix the plate. : Figure 2.5-10
4 ► Perform 2 ► again.

5 ► If the tip of the tip shifts by a large amount from the center position of the container, perform
3. again.
6 ► Press the [Service] [Adjustment S/R Probe, R.Disk, Mix] [S/R Probe-X Rack Sampling] key
to perform fine adjustment in the moving direction of pipetter. (The same as sampling
position adjustment of the main unit).
7 ► When the tip of the tip has been adjusted to be roughly in the center of the container by
procedures 1 - 6, perform 2 ►. again to adjust finely the flow direction of the rack. (If fine
adjustment is not required, you do not need to perform 7 ► and 8 ►..)
8 ► Press the Front key or Back key on Panel PC screen to perform fine adjustment of rack stop
position. (Moving forward and backward for 5 pulses can be performed, resolution: 0.15
mm/pulse)
8.2 ► After completion, press the OK key to finish adjustment.
9 ► Remove the fixing of the test tube guide performed in 1 ►..
10 ► Perform 2 ►again.
11 ► Loosen the test tube guide fixing screws (4 screws, M4) and adjust the fixing position so that
all 4 resin rollers of the test tube guide can touch the test tube. : Figure 2.5-11
12 ► Attach the table cover L2. (3 screws M4, top surface).

Figure 2.5-1 Setting up the cobas e411
1 Cover for Gripper

2 R.Lid
3 S.Disk
4 Front Cover Assy
5 Rear Cover
6 Side Base
7 S Jacket Assy
8 S Disk Drive Assy
9 Table Cover L

Figure 2.5-2 Remove Three Bushes
1 Bush
2 Rear Cover for Sampler
3 Loader Cover

Figure 2.5-3 Removing the Coupling Plate
1 Pull
2 Bush
3 M6 Screw
4 Coupling Plate

Figure 2.5-4 Setting up the PCB and DSW
1 Cover for PCB Rack (P/N 741-4541)

2 PCB Rack Assy
3 PCB Rack Assy
4 Cover for Circuit Board (P/N 741-1583)
5 Spacer
6 Nut M3 Spring Washer 3
7 Screw M3×6 Washer 3 Spring Washer
8 DIP Switch
9 RS CONT DCircuit Board Assy (P/N 741-5074)
10 PCB Rack Assy

Figure 2.5-5 Connection of the Cable
1 BCR Cable
2 Earth
3 BCR
4 BCR Circuit Board Assy
5 P510, P511 Connector
6 M5 Screw
7 Coupling Plate
8 Cable
9 J900
10 Clamp(HP-10N)
11 DIST-F Circuit Board (P/N:741-5028)
12 Coupling Plate
13 UIRS-C Circuit Board Assy (P/N:741-5081)
14 J343 Connector
15 J342

Figure 2.5-6 Connection to the Instrument
1 Screw
2 Couple Block 2
3 Couple Block 1

Figure 2.5-7 Installation of Covers
1 Acryl Cover Assy

2 J908
3 Rear Cover for Sampler
4 Clamp
5 The Communication Cable
6 Label
7 Rear Cover
8 Front Cover Assy
9 Table Cover L2
10 Stat Cover
11 Loader Cover

Figure 2.5-8 Height Adjustment
1 Adjuster
2 Water Level
3 Lock Nut

Figure 2.5-9 Rack Sampler System

Figure 2.5-10 B Line (Top View)
1 Test Tube Guide Open/Close direction

2 Test Tube Guide
3 Sensor fixing screw (M3)
4 Sampling position Sensor fixing plate
5 B line
6 A line

Figure 2.5-11 B Line (Side View)
1 Test Tube Guide Fixing Screw (M4) (Opposite side, too)

2 Roller made of resin (Opposite side, too)

2.6 Checks/Adjustments During Installation

The following adjustments should be checked during analyzer installation because they are very
import for good instrument performance. The instrument should always be observed during the initial
operations.
Refer to Chapter 4.5.2 with regard to any other positions that need to be adjusted.
2.6.1 Bead Mixer
2.6.1.1 Check Mixer Speed (see also Chapter 5.3.8)

To check the mixer speed, use one of the following procedures:
Place reagent packs in positions 1 to N .
Start the Mixing Check ( [Maintenance][Check][Mixing Check] ) and enter < N > repititions.
Confirm the following mixer speeds using an rpm meter :
Table 2.6-1
In air In liquid
2050 rpm ± 100 rpm 2000 rpm ± 100 rpm
2.6.1.2 Mixer Adjustment

Table 2.6-2
Adjusted item Item to be confirmed How to adjust
1 Beads Mixer Carry out the
1 ► Make sure that the mixing paddle is straight.
Rinse Station “Mixer-Horiz.Rinse” function
in the “Adjustment S/R Probe
2 ► Confirm visually that when the beads mixer is in the R.Disk Mixer” screen.
horizontal home position, there is a distance of 2 mm
or more between the mixing arm and the end of the (See Chapter 4.4.4. Service
U-shaped cut of the table cover and that the mixing Manual )
arm is located approximately in the middle of the U-
shaped cut. If not, adjust the beads mixer and/or
relevant units referring to the procedures described in
the latter half of 3 ►.
3 ► Confirm visually that the mixing paddle is adjusted as

concentrically as possible with the washing station
Note:. If not, adjust the beads mixer and/or relevant
units by applying one or more of the following three
options.
3.2 ► Adjust the table cover mechanically.
3.3 ► Carry out the " Mixer-Horiz.Rinse " function in the "
Adjustment S/R Probe R.Disk Mixer " screen.
3.4 ► Adjust mechanically the beads mixer head rotational

angle around the arm.
4 ► Make sure that the mixing arm in home pos. does not
interfere with the pipetter.
2 Beads Mixer-R Mix Carry out the “Mixer-

1 ► Attach the reagent disk cover.
Horiz.Reag.Mix” function in
the “ Adjustment S/R Probe
1.2 ► Confirm visually that the mixing paddle is adjusted as R.Disk Mixer ” screen.
concentrically as possible with the reagent disk cover
hole.
3 Beads Mixer Carry out the “Mixer Up/Down”

Up/Down • Detach the reagent disk cover. function in the “Adjustment
S/R Probe R. Disk Mixer”

Adjusted item Item to be confirmed How to adjust

screen.
• Place a RackPack in pos. 1 of the reagent disk.
1 ► Confirm visually that the mixing paddle lower end is

just level with the upper edge of the opening of the
RackPack Note:.
Note: You may manually push down the mixing arm to allow easier confirmation.
Note: You may put a thin sheet of paper on the RackPack opening to allow easier confirmation
(paddle top should touch the paper).
2.6.1.3 Mixer Paddle Shape
Examination of Paddle Shape
1 ► To examine the mixing effect, a new or used RackPack (not mixed for at least 20 hours)
should be placed in reagent rotor pos. 1.
2 ► Start the Running Test from [Assay performance check] screen because the RackPack will
be mixed initially (15 s). The initial mixing should create a homogeneous solution of
microparticles.
3 ► Stop the running test after mixing and check the bead solution: No foam should be visible on
the reagent surface (only valid for 3 to 5 ml filling volume). No bead sediment should be
visible at the bottom of the bottle (check from below, see Figure 2.6-1 and Figure 2.6-2)
Note: Perform restore parameter after running test has been stopped
Figure 2.6-1
No bead sediments visible at the bottom of the bottle (seen from below): PADDLE OK
Figure 2.6-2
Bead sediments visible at the bottom of the bottle (seen from below): PADDLE NOT OK

2.6.2 Pipetter Adjustment

Table 2.6-3
Adjusted item Procedure How to adjust
1 Pipetter-Z C/T Buffer Detach the tip, if any from the pipetter probe. Carry out the "S/R Probe-Z
Confirm visually that pipetter probe end with no tip C/T Buffer" function in the
is pretty level with the buffer station surface at the "Adjustment S/R Probe R Disk
tip eject position. Mixer" screen.
2 Pipetter-Z C/T Buffer Bottom Detach the tip, if any from the pipetter probe. Carry out the "S/R Probe-Z
Place a tip in Tip Pos. 1 of the buffer station. C/T Buffer Bottom" function in
Confirm visually that the pipetter probe end with no the " Adjustment S/R Probe R
Disk Mixer " screen.
tip is pretty level with the buffer station surface at
the tip eject position.
3 Pipetter-Z Beads Bottom Attach a tip to the pipetter probe. Carry out the "S/R Probe-Z
Place an empty RackPack in pos. 1 of the reagent Beads Bottom" function in the
disk. " Adjustment S/R Probe R
Automatically checked ! Disk Mixer " screen.
4 Pipetter-Z S.Cup Bottom Attach a tip to the pipetter probe. Carry out the "S/R Probe –Z
Place a Hitachi sample cup in Pos. 1 of the sample S.Cup Bottom" function in the
disk or Pos. 1 of a rack in STAT pos. " Adjustment S/R Probe R
Automatically checked ! Disk Mixer " screen.
2.6.3 Sipper adjustment

Table 2.6-4
Adjusted item Procedure How to adjust
Sipper Z adjustment The sipper Z adjustment has to be done without a bottle in place.
1 Sipper-Z Incubator Confirm visually that the sipper probe Carry out the “Sipper-Z
end is just level with the upper surface of Incubator” function in the
the holder in the sipping position. “Adjustment Sipper Cap O/C
BCR” screen.
2 Sipper-Z Inc. Bottom Take PC1 bottle and CC2 bottle off. Carry out one of the following
Sipper-Z PC1 Bottom Automatically checked ! functions in the “Adjustment
Sipper Cap O/C BCR ”.
Sipper-Z CC2 Bottom
1. Sipper-Z Inc. Bottom
2. Sipper-Z PC1 Bottom
3. Sipper-Z CC2 Bottom
2.6.4 Electronic adjustments

The following electronic checks should be done:
Table 2.6-5
Unit How to Adjust
1 Pipettor LLD Refer to chapter 5.3 for adjustment procedure of Pipettor LLD, Sipper LLD
2 Sipper LLD and Clot.
3 Pressure sensor
2.6.5 Rack Sampler adjustments
2.6.5.1 Adjustment table

In case of Rack Sampler installation we recommend that all positions are checked. Refer also to
Chapter 4.5.2.2.
Table 2.6-6
Unit Adjusted Item Item to be Confirmed How to Adjust

Unit Adjusted Item Item to be Confirmed How to Adjust

1 A Line Not applicable ---
1. Belt tension.
The rack guide and the rack feed arm on the Mechanical adjustment
2. Mounting position of
rack tray must be at right angles.
the rack feed arm.
The center of the rack guide on the rack tray Mechanical adjustment
3. Position of the rack
must correspond with the center of the rack
guide at the buffer
guide on the buffer base.
base.
The space between the rack feed arm and the Carry out the “A Line Loading
rack must be 1 to 2 mm when the rack is Pos.” function in the “Adjustment
feed end.
pressed against the rack rail on the B Line. Rack” Screen.
2 B Line Not applicable ---
1. Belt tension.
The tip must be in the center of the tubes (within Carry out the “B Line Sampling
2. Sampling position.
±1 mm). Pos.” function in the “Adjustment
Rack” Screen.
The center of the notch to prevent the rack from Carry out the “B Line Unloading”
toppling must correspond with the center of the function in the “Adjustment Rack”
feed end.
rack guide on the buffer base of the C Line Screen.
(within ±1mm).
Automatically determines the reading position. Carry out the “B Line B.C.R. Auto”
4. BCR Reading Position.
function in the “Adjustment Rack”
Screen.
3 C Line Not applicable. ---
1. Belt tension
The rack guide and the rack feed arm on the Mechanical adjustment
2. Mounting position of
the rack feed arm. rack tray must be at right angles (within ±1 mm).
The center of the rack guide on the rack tray Mechanical adjustment
3. Position of rack guide
must correspond with the center of the rack
at the buffer base.
guide on the buffer base (within ±5 mm).

2.6.5.2 Explanation Adjustment Sample Position

Place a rack with a primary tube (diameter 10 or 13 mm) in rack position one at the STAT position of
rack sampler unit.
Carry out "B line sampling pos." from the screen "Adjustment Rack".
Check the current sample position adjustment!
If the pipetter needs correction to left/right (x-axis, see Figure 2.6-3), quit the current screen with
"Cancel" key, change to the "Adjustment S/R Probe R.Disk Mixer" screen and carry out "S/R Probe-X
Rack Sampling" from the screen.
B line sample position
Figure 2.6-3
If the pipetter needs correction in up/down direction (y-axis, see Figure 2.6-3), change the rack
position with "Forward" or "Backward" key.
Note: The hook will only move the rack backwards (see Figure 2.6-3). For forward hook
movement, you have to push the rack by hand to get the actual position.The range of
software adjustment for B line sample pos. is only ± 5 steps because of the design of the
racks (Figure 2.6-4).

cobas e411 rack
Figure 2.6-4
If the range of software adjustment for B line sample pos. is not sufficient, change the sample position
manually. To adjust manually, move the whole sample detector B assembly (see Figure 2.6-5) in the
corresponding direction. The detector B assembly is fastened with two screws on the left and one
screw on the right. After changing the position manually, optimize again with the software (as
described above).
B line sample position, adjustment possibilities
Figure 2.6-5
2.6.5.3 Adjustment the Barcode Reader Position
Adjusting the Barcode Reader Base Position
Adjust the BCR base position according to Figure 2.6-6.
Detail:

Adjust the position of BASE (P/N741-7641) so that the distance between Surface A of the notch
located on BASE and Surface B of the readout window becomes 38.5 ± 1mm.
Figure 2.6-6 Adjusting BASE position
Figure 2.6-7 How to adjust the BCR position – Reference 1

Figure 2.6-8 How to adjust the BCR position – Reference 2
Automatic Adjustment of BCR Readout Position
Perform automatic adjustment of BCR readout position according to the following.
1 ► Attach all COVER ASSY on the analyzer body.

2 ► Attach COVER on the rack sampler body.
3 ► Open Front top COVER on the analyzer body and on the rack sampler body.
4 ► Perform automatic adjustment of the BCR readout position. Use calibrator and control vials
to perform the adjustment.

RD/Hitachi coban e411 Service Manual
2.7 Table of Contents
2.7.1 Method to detach the external covers

1. Detaching the REAR COVER (P/N: 741-8065)
1 ► Detach the REAR COVER by removing the two SCREWS (M641007: M4×6 TP screw) that
fix it.
Figure 2.7-1
2. Detaching the PC Unit (P/N: 741-0231)
1 ► Remove the two SCREW COVERS (E)(P/N 741-8080).
Figure 2.7-2
2 ► Detach the WIRE COVER (1) by unfastening the two SCREWS (M641051: M4×6 Terminal
screw) that fix it and then shifting it leftward.

Figure 2.7-3
3 ► Unlock each of the eight CRAMPS (P/N: 731-1415, J839403, J839411) and release the PC
wires
Figure 2.7-4
4 ► Pull out the PC wires from the Wire-fix of the FRONT COVER S1 (P/N: 741-8051) to
slacken them.
Figure 2.7-5
5 ► Remove the three HEXAGON SOCKET HEAD CAP BOLTS (M330621: M4×16) that fix the
PC unit and then remove the PC unit shifting it in the direction indicated in the figure below.

Figure 2.7-6
6 ► Place the PC UNIT temporarily on the left area of the instrument. When doging this, keep
the base part of the UNIT opened.
Figure 2.7-7
3. Detaching the TOP COVER (P/N: 741-8053)
1 ► Open the TOP COVER, and unfasten the two SCREWS (M641009: M4×8 TP screw) that fix
the left part of the GUIDE COVER (P/N: 741-8070)
Figure 2.7-8
2 ► Remove the two SCREWS (M641009: M4×8 TP screw) that fix the right part of the GUIDE
COVER.
Figure 2.7-9
3 ► Detach the GUIDE COVER by shifting it rightward.

Figure 2.7-10
4 ► Fix the SCREWS unfastened in 1 ►(Figure 2.7-8) and also the SCREWS detached in 2
►(Figure 2.7-9), to the TOP COVER
Figure 2.7-11
5 ► Remove the eight SCREWS (M641136: M4×10 SCREW WITH SPRING WASHER,
M871105: SCREW WITH WASHER) that fix the TOP COVER.
Figure 2.7-12
6 ► Lift the TOP COVER upward to disconnect it from HINGE PLATES (P/N: 741-8074)
Figure 2.7-13
4. Detaching the FRONT COVER S3 (P/N: 741-8064)
1 ► Remove the two SCREW CAPS (E)(P/N: 741-8080)

Figure 2.7-14
2 ► Remove the two SCREWS (M641009: M4×8 TP screw) that fix the FRONT COVER S3 and
detach it by lifting it upward.
Figure 2.7-15
1 ► Remove the three SCREW COVERS (E)(P/N: 741-8080).
Figure 2.7-16
2 ► Remove the three SCREWS (M641009: M4×8 TP screw, M641056: M4×16 Terminal screw)
that fix the FRONT COVER S2. And remove the FRONT COVER S2 by pulling it frontward.

Figure 2.7-17

1 ► Remove the three SCREWS (M641052: M4×8 Terminal screw, M641054: M4×12 Terminal
screw, M641056: M4×16 Terminal screw) that fix the FRONT COVER S1. And remove the
FRONT COVER S1 by lifting it upward. When doing this, be careful not to hurt the inside
surface of the FRONT COVER S1.
Figure 2.7-18

2.7.2 Method to attach the external covers

1. Attaching the FRONT COVER S1 (P/N: 741-8051)
1 ► Bring the FRONT COVER S1 above the mounting position, and lower it carefully paying
attention to its alignment. When doing this, be careful not to hurt the inside surface of the
FRONT COVER S1. After placing it on the main unit base, temporarily fix the FRONT
COVER S1 to the main unit base using three SCREWS (M641052: M4×8 Terminal screw,
M641054: M4×12 Terminal screw, and M641056:M4×16 Terminal screw)
Figure 2.7-19

1 ► Shift the FRONT COVER S2 in the direction indicated in the figure below. After inserting the
pins of the FRONT COVER S2 into the receptive holes on FRONT COVER S2 (on both right
and left sides), fix the FRONT COVER S2 to the main unit base using three SCREWS
(M641009: M4×8 TP screw, M641056: M4×16 Terminal screw). When doing this, keep the
FRONT COVER S2 pressed in the direction indicated in the figure below.
Figure 2.7-20
2 ► Attach the three SCREW COVERS (E)(P/N: 741-8080).
Figure 2.7-21

3. Adjusting the Mounting Position of the FRONT COVER S1
1 ► Keeping the FRONT COVER S1 pressed to the FRONT COVER S2, fasten tightly the three
SCREWS that were fastened temporarily in 1 ► (Figure 2.7-19), to fix the FRONT COVER
S1 to the main unit base. When doing this, pay attention to minimize the gap between the
mating faces of the FRONT COVER S1 and FRONT COVER S2 (on both right and left
sides).
Figure 2.7-22
1 ► Place the FRONT COVER S3 in the mounting position and fix it to the FRONT COVER S2
using two SCREWS (M641009: M4×8 TP screw).
Figure 2.7-23
2 ► Attach the two SCREW COVERS(E)(P/N: 741-8080).
Figure 2.7-24

5. Attaching the TOP COVER (P/N: 741-8053)
1 ► Using your hand, raise the two HINGE PLATES (P/N: 741-8074) so that they stand vertical
to the Side A (see the figure below) of the FRONT COVER S1.
Figure 2.7-25
2 ► Insert the two HINGE PLATES into the TOP COVER’s receptive holes and fix it temporarily
by using eight SCREWS (M641136: M4×10 SCREW WITH SPRING WASHER, M871105:
SCREW WITH WASHER).
Figure 2.7-26

3 ► Adjust the position of the TOP COVER as follows:

3.2 ► Adjust the position of the TOP COVER so that Side B of the FRONT COVER S1 does not
interfere with Side C of the TOP COVER. (i.e., Match Side D of the FRONT COVER with
Side E of the TOP COVER)
Figure 2.7-27
3.3 ► Fasten tightly the SCREWS that were fasten temporarily in 2 ►(Figure 2.7-25) to fix the
TOP COVER to the main unit base.
4 ► Open the TOP COVER, and unfasten the two SCREWS (M641009: M4×8 TP screw) that fix
the left part of the HINGE GUIDE 1 (P/N: 741-8061)
Figure 2.7-28

5 ► Remove the two SCREWS (M641009: M4×8 TP screw) that fix the right part of the HINGE
GUIDE 1.
Figure 2.7-29
6 ► Shift the GUIDE COVER (P/N: 741-8070) in the direction indicated in the figure below.
Using the SCREWS you have removed in 5 ►(Figure 2.7-29), fix the GUIDE COVER to the
TOP COVER.
Figure 2.7-30

6. Attaching the PC Unit (P/N: 741-0231)
1 ► Shift the PC unit with its base part closed in the direction indicated in the figure below, and
place it on the FRONT COVER S1. Using three HEXAGON SOCKET HEAD CAP BOLTS
(M330621: M4×16), fix the PC unit to the FRONT COVER S1.
Figure 2.7-31
2 ► Properly route the PC wires through the eight CRAMPS and the Wire-fix of the FRONT
COVER S1 to secure them.
Figure 2.7-32

3 ► Shift the WIRE COVER (1) (P/N: 741-8069) in the direction indicated in the figure below and
place it on the FRONT COVER S1. Using two SCREWS (M641051: M4×6 Terminal screw),
fix the WIRE COVER (1) to the FRONT COVER S1.
Figure 2.7-33
4 ► Attach the two SCREW COVERS (E)(P/N: 741-8080).
Figure 2.7-34
7. Attaching the REAR COVER (P/N: 741-8065)
1 ► Place the REAR COVER in the mounting position and fix it to the main base unit using two
SCREWS (M641007: M4×6 TP screw). When doing this, be careful no to sandwitch the PC
wires you have routed in 2 ► (Figure 2.7-32).
Figure 2.7-35

2.7.3 Mmethod to detach the PC Unit

1. Detaching the REAR COVER (P/N: 741-8065)
1 ► Detach the REAR COVER by removing the two SCREWS (M641007: M4×6 TP screw) that
fix it.
Figure 2.7-36
2. Detaching the PC Unit (P/N: 741-0231)
1 ► Remove the two SCREW COVERS (E)(P/N: 741-8080).
2 ► Detach the WIRE COVER (1) (P/N: 741-8069) by removing the two SCREWS (M641051:
M4×6 Terminal screw) and then shift it leftward.
Figure 2.7-37

3 ► Unlock each of the eight CRAMPS (P/N: 731-1415, J839403, J839411) and release the
wires that run through them.
Figure 2.7-38
4 ► Pull out the PC wires from the Wire-fix of the FRONT COVER S1 (P/N: 741-8051) to
slacken them.
Figure 2.7-39
5 ► Remove the three HEXAGON SOCKET HEAD CAP BOLTS (M330621: M4×16) and detach
the PC Unit by shifting it in the direction indicated in the figure below.
Figure 2.7-40

6 ► Place the PC unit temporarily on the left of the instrument keeping the base part of the unit
opened.
Figure 2.7-41
2.7.4 Method to attach the PC Unit

1. Attaching the PC Unit (P/N: 741-0231)
1 ► Shif the PC unit in the direction indicated in the figure below and place it on the FRONT
COVER S1. Fix the PC unit to the FRONT COVER S1 using three HEXAGON SOCKET
HEAD CAP BOLTS (M330621:M4×16)
Figure 2.7-42

2 ► Properly route the PC wires through the eight CRAMPS and the Wire-fix of the FRONT
COVER S1 to secure them.
Figure 2.7-43
3 ► Shift the WIRE COVER (1) (P/N: 741-8069) and place it on the FRONT COVER S1. After
that, fix them using two SCREWS (M641051: M4×6 Terminal screw)
Figure 2.7-44
4 ► Attach the two SCREW CAPS (E)(P/N: 741-8080)
Figure 2.7-45
2. Attaching the REAR COVER (P/N: 741-8065)
1 ► Place the REAR COVER on the mouting position and fix it to the main unit base using two
SCREWS (M641007: M4×6 TP). When doing this, be careful no to sandwitch the PC wires
you have routed in 2 ►(Figure 2.7-43).

Figure 2.7-46

3.1 Description of Flow Path

• System water is supplied by the water supply bottle (capacity: 3.5 liters) and the water level is
monitored by a float switch.
• Water is pumped by a magnet pump and distributed to the pipetter and sipper inside/outside wash
and also to the mixing paddle wash via a branch pipe and the solenoid valves (SV).
• The pipetter line has clot detection (Refer to Chapter 5.3.4 for principle of clot detection), and
checks for blood clots and serum gel separator clots, etc.
• Reacted solution is sipped into the measuring cell in the detection unit by means of the sipper
probe; waste is transferred to the waste solution bottle after measuring. All system water that is
used for washing (P) & (S) probes and paddle is collected in the waste solution bottle via the
cleaning path (P), & (S). The waste bottle has a capacity of 4 liters. A mechanical switching unit
detects whether the bottle is full and causes the instrument to go into sampling stop.
• System water quality requires less than 10µS/cm conductivity. If water conductivity is higher, liquid
level detection fails will occur because the detection method relies on a capacitance principle.
• Refer to the overall piping diagram for details of the flow path.

3.1.1 Overall Piping Diagram

See pdf\OverallPipingDiagram.pdf for more details

3.1.2 List of Parts

Table 3.1-1 List of Valves and Pumps
SV/Pump
Part Name Type Voltage Application Part No.
No.
SV1 Solenoid Valve UDV Assy UDV-2-M6C 24VDC For Pipetter Syringe 741-0830
SV2 ↑ ↑ ↑ For Sipper Syringe 741-0830
SV3 Pinch Valve 2 Assy AP-2602-13-HA ↑ For Sipper Line Probe 741-0833
SV4 ↑ ↑ ↑ For Sipper line Drain 741-0833
SV5 Solenoid Valve UDV Assy UDV-2-M6C ↑ For External Washing of 741-0830
Pipetter Tip
SV6 ↑ ↑ ↑ For Washing Beads 741-0830
Mixing Paddle
SV7 ↑ ↑ ↑ For External Washing of 741-0830
Sipper Probe
Pump DC Magnet Pump Assy MD-6Z-DC-7 ↑ Water Supply 741-0832
Table 3.1-2 List of Tubes

No. Part Name Material, Length Part No. Roche ID Remarks
0 Tube B for Sipper Syringe 741-0821
1 Tube 1 741-0807
2 Tube 2 741-0808
3 Sipper Drain Tube Tygon Tube R3603 T3604-23-1

3.17ID x 3.35OD L=750
4 Drain Tube SR Tube 8x12 FB G153177
Cleaning Bath (S) L=150
5 Tube for Tip Wash L=930 T3604-23-1
6 Tube for Mixer Bath L=760 T3604-23-1
7 Tube 7 741-0809
8 Tube 8 741-0543
9 Tube 9 741-0803
10 Water Return Tube SR Tube 4x8 FB G153176

L=350
11 Water Supply Tube Silastic Tube 8ID x 3T G153171
L=150
12 Pump Out Tube L=50 G153171
13 Joint Tube L=80 G153171
14 Ventilation Tube SR Tube 4x8 FB G153176

L=300
15 Tube B for Measuring Cell 741-0822
16 Tube B for Sipper 741-0820
17 Tube Set IH L=180 ( 2 PCS ) 741-0941

(Pinch Tube)
18 Tube 510 741-1778
19 Tube 465 741-1775

No. Part Name Material, Length Part No. Roche ID Remarks

20 Heat pipe (Line heater) 741-0967

3.2 System Volume
Introduction
The system volume value is needed by the system to ensure that the sample is transported to the
measuring cell working electrode surface. If the system volume is wrong the results may vary. (Bad
CV´s )
Note: Whenever a part on the sipper line (excluding the measuring cell ) is exchanged the system
volume has to be determined.
3.2.1 Definition of System Volume

The volume between the sipper needle top and the measuring cell outlet.
The mean system volume of the e411 is 460 µl ± 30 µl.
The measuring cell itself has a volume of 60 µl ± 5 µl.
3.2.2 Determination of System Volume

Preparation
Place 1 (one) set of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell at Position
1, right side in the system reagent container.
3.2.2.1 Procedure
► Make sure that the instrument is in standby status.
► Touch the [Utility] button.
► Touch the [Maintenance] button.
► Touch the [Service] button.
► Touch the [System Volume Check] button and Touch the [Select] button.
► Touch the START button in the screen.
The system volume is determined as follows:

The sipper line is first filled with ProCell. An air bubble of 100 µl is set. The air bubble is transported to
the measuring cell. Before the bubble arrives at the cell the measuring cell voltage is switched on. The
bubble separates the reference electrode (RE) from the counter electrode (CE) and working electrode
(WE). When the bubble leaves the cell a current peak is created, and this peak is measured to
calculate the volume (refer to Figure 3.2-1 and Figure 3.2-2).
Note: After the procedure has been finished successfully the instrument returns to Standby. If an
error message appears, refer to troubleshooting. The system volume value is not displayed.

Figure 3.2-1
Figure 3.2-2
3.2.3 Storage of the System Volume Value / Data Handling

The determined system volume is stored as a value between 1 to 7 in the static SRAM of the CPU.
The value is also stored on the database file.
When the instrument is switched on (main switch), the value is loaded from the static SRAM (like
adjustment data) and CF.

3.3 Cleaning Procedures
Introduction
Two cleaning procedures are recommended for the e411 flowpath.

Liquid flow cleaning (see Chapter 3.3.1)
This cleaning procedure is also part of the customer maintenance (see Operator’s Manual) and should
be carried out frequently.
Service liquid flow cleaning (equivalent to 3 customer cleanings) should only be performed in the event
of high grade contamination problems (e.g. heat pipe blockage)
Cleaning for Fluidics System (see Chapter 3.3.2)

This procedure cleans tubings and the washing stations, but not the sipper line.
3.3.1 Liquid Flow Cleaning
Introduction
Contamination in the sipper system could potentially degrade sample accuracy and precision, or
possibly block the measuring cell flow path. Liquid flow cleaning keeps the sipper liquid flow path clean
and maintains the integrity of the measuring cell.
The customer should perform LFC on a frequent basis. Please train all your customers according to
the procedure described below and inform them about the importance of keeping the liquid flow path
clean and the measuring cell at the best performance level.
If operators perform this procedure frequently it will lead to fewer customer complaints.
Required materials:SysClean adapter Ident. No.: 1933159.910
SysClean Solution Ident. No.: 1298500
Recommended frequency*: Every two weeks or after 2500 - 3000 cycles
∗ If customer maintenance has been done as recommended, it is only necessary to carry out an additional customer
cleaning at the PM visit. The service LFC is only necessary during PM if the sipper line is highly contaminated or if
LFC has not been carried out regularly by the customer.
Operator time: Approx. 3 minutes
Analyzer time: User LFC: Approx. 16 minutes (user)
Service LFC: Approx. 32 min + time for MC prepare cycles
Precautions: The cleaning solution is corrosive. Wear protective gloves and
glasses when handling this solution.
Procedure for Customer / Service

1. User Replace the PC bottle at position 3 by the SysClean adapter (keep
the CC bottle in position).
Figure 3.3-1

Insert the adapter with the marking "USER" in direction towards the
back of the instrument. Fill the SysClean solution to the edge of the fill
mark on the adapter (approx. 9 ml). PC/CC bottle has to be placed at
the left side.
2. Service Same procedure as for customers but using the Service position of
the adapter.
3. User Touch the Liquid Flow Cleaning button on the screen (Screen: Util /
/Service Maintenance).
4. User The number of LFCs should be 1 for User maintenance.
5. Service The number of LFCs should be 3 for service.
Take out the SysClean adapter and place ProCell and CleanCell
bottles in all positions.
Perform Measuring Cell Preparation cycles. [Press ”MC
Preparation” in Maintenance screen; select number of cycles]
Start the LFC procedure shortly after filling up the SysClean solution.
After the instrument returns to Stand by remove the SysClean adapter and discard the remaining ISE
solution.
To avoid an unpleasant odor, please empty the waste container at the end of the liquid flow cleaning
procedure.
After a Service LFC has been performed customers should check all controls and carry out a
calibration if necessary. This is not necessary for normal routine with customer LFC.
3.3.2 Cleaning Procedure for Fluidics System

The fluidics system consists of the tubing system, the pipettor, all wash stations except the part
between the sipper probe and SV3) The cleaning procedure is a function to be carried out when
frequent high water conductivity errors happen and if the system is contaminated with bacteria, algae,
etc. Contamination can lead to problems with the pipetting or washing processes, thereby degrading
the sample accuracy and precision.
Note: This is not a part of the routine maintenance for the e411. This procedure should only be
used if contamination has occurred.
3.3.2.1 Required materials

- 30 % Perhydrol-Solution; Fa. Merck Cat. No.: 1.07209.1000
Procedure
1 ► Remove the system water container. Fill with 3% Perhydrol solution and empty the
liquid waste container.(Put about 100 ml 30 % Perhydrol solution in the tank, and fill
up with purified water to the 3 L mark. (3.5L volume). Mix carefully. Replace the
system water container.
2 ► Touch the Maintenance button on the screen.
3 ► Touch the Service Cleaning button on the screen.
4 ► Start. The procedure takes 50 min and consumes about 2.8 L. When cleaning is
finished the status changes to Stand-by. Allow the solution to react for 20 min.
5 ► Empty the liquid waste container.
6 ► Clean the system water container and refill with system water. Replace the container
on system.
7 ► Touch the Cleaning button again. Rinsing with system water starts (50 min).

8 ► Repeat points 5 to 7 twice to guarantee that the whole system is filled with system
water.
9 ► After finishing, the top of the screen changes to Stand-by. Please empty the liquid
waste container and refill the system water container with system water. The system
is now ready for the normal routine.
In case of frequent high water conductivity errors, check that the pipettor LLD voltage is 1.5 V or lower.
Otherwise, repeat the cleaning process with system water until the voltage is reduced to 1.5 V.
In case of strong contamination repeat the whole cleaning procedure again.
Note: There are some instruments that generate the alarm "Distilled Water: 25-01-01" during
Cleaning and the status shifts to Stand-by. However there is no problem with the
performance of cleaning function if enough system liquid (around 3 L) has run.

3.4 SysWash
3.4.1 Introduction
SysWash is used as an additive to the wash water in the e411. SysWash increases the rinsing
efficiency between pipetting steps.
SysWash also contains a preservative to protect the system from contamination (e.g. by bacteria).
The detergent solution is particularly necessary when performing analyses using e411 infectious
disease assays, but can also be used for the other parameters.
Before SysWash is regularly used on the instrument, service has to carry out the Rinsing procedure
(see below).
After the rinsing procedure has been finished, SysWash has to be used in the system water in the
recommended concentration (prepared working solution contains 0.075% detergent).
Note: The SysWash is recommended for use in all e411 systems.

For further details refer to “Product Information” inside the SysWash package.
SysWash Cat No. 1930346 1 x 500mL
3.4.2 SysWash Rinsing Procedure

1 ► Preparing the Mixture in the System Water Container
1.1 ► Take 35 mL of SysWash and pour it into the empty e411 wash water container. Fill the
container with distilled water to the highest mark (dilution ratio is now 1 + 100).
Note: When pouring in the water make sure that it flows quickly enough, but avoid the formation of
foam. This ensures that the additive will be dispersed evenly in the wash water, so no
additional mixing will be necessary.
2 ► Analyzer Rinsing Procedure

2.1 ► Proceed as follows to ensure that the active component is present in the tip wash station for
the first determination: Start CLEANING-function ([Util] [Maintenance] [Service Cleaning]
[Start])
2.2 ► Run the CLEANING-function 2-3 times. Make sure that the total rinse volume is ≥ 5 L
*.*This amount is necessary to replace the volume in the buffer container below the system
water container.

4.1 Overview
4.1.1 Location
See Chapter 4.2.
4.1.2 Outline of Mechanical Units
4.1.2.1 Sample Disk Mechanism

The sample disk mechanism rotates the sample disk to position the sample in the pipetting position.
4.1.2.2 Reagent Disk Mechanism

The reagent disk mechanism consists of the following two units:
1. Reagent Disk Mechanism: The reagent disk mechanism causes the rotation of the reagent disk to
bring the reagent in the pipetting position.
2. Reagent Cooling Unit: The reagent cooling unit is a Peltier-element temperature controller that
controls the reagent temperature.
4.1.2.3 Cap Open/Close Mechanism

The cap open/close mechanism has three separate hooks. Using these hooks, the mechanism opens
and closes the snap-in cap of the rack pack, coinciding with pipetting the reagent or stirring by the
beads.
4.1.2.4 Beads Mixer Mechanism

The beads mixer stirs the beads in the reagent rack pack right before pipetting the reagent.
4.1.2.5 Pipetter Mechanism

The pipetter is a unit that picks up the disposable tip using the X-Z mechanism, aspirates a sample,
calibrator, reagent (beads, R1, and R2), and diluent, and injects the material into the reaction vessel.
4.1.2.6 Buffer Station

The buffer station is a picking-up position of tips for the pipetter and an injection position for sample
and reagent into the reaction vessel.
4.1.2.7 Gripper Mechanism

The gripper consists of the following three units. It carries the tip/vessel from the container to buffer
station and from the buffer station to the incubator.
1. Tip/Vessel Carrier - Transports the tip/vessel by using the X/Y/Z/Grip mechanism.

2. Container Station - Capable to carry up to three tip containers and three vessel containers.
3. Incubator Station - On its heat blocks are 32 incubator stations and 1 sipping station.
4.1.2.8 Sipper Mechanism

The sipper carries the probe that is connected to the syringe with a tube to each station throught the
measuring cell.

4.1.2.9 System Reagent Mechanism

The system reagent mechanism is a unit that keeps the liquid temperature constant inside the AB and
CC bottles. It has a case that has grooves for an AB bottle and a CC bottle. By setting an AB bottle
and a CC bottle, one at a time, it adjusts the case temperature by using a Peltier temperature
controller.
4.1.2.10 Syringe Mechanism

The syringe consists of the two systems below. It moves the liquid by pumping it up with the force
driven by the plunger’s up-and-down movement and by the shift of the position of the probe in each
system.
1. Pipetter Syringe (on the left side) - Aspirates and pipettes a specified amount of each sample,
reagent, or beads using the pipetter probe and tube.
2. Sipper Syringe (on the right side) - Aspirates the reaction mixture through the sipper probe, tube,
and measuring cell.
4.1.2.11 System Water Container (Float SW)

The system water container consists of the following two units. Driven by the pump and valve, it
provides system water to each wash bath and syringe.
1. System Water Container - Capacity: 3 liters

2. Buffer Tank - Capacity: 1 liter, with float SW.
4.1.2.12 Liquid Waste Container

The liquid waste container consists of the following two units. It collects the wash solution and reaction
mixture.
1. Liquid Waste Container - Capacity 4 liters.

2. Container Station (with a fill-level detector with a detection level: 3.5 liters)
4.1.2.13 Solid Waste Mechanism

The solid waste mechanism vibrates the waste box to smooth the used tips and vessels piled up in the
waste box so that the space to collect the tips and vessels is maximized.
4.1.2.14 Magnet Drive Mechanism

The magnet drive mechanism is located in the detection unit below the measuring cell. In the analyzer,
it is used for positioning the magnet in the detection point of the measuring cell and for taking the
magnet away from the cell.
4.1.2.15 Matrix BCR Mechanism

The matrix BCR mechanism is a unit that contains a rotating mechanism that is used for scanning bar-
coded data with a bar-code reader. The bar-code reader scans a bar code attached to a sample tube,
or a reagent rack pack, or scans a bar-code card that carries the information of these three in
combination

4.2 Location of Mechanisms
4.2.1 Analyzer
Figure 4.2-1
1 Pipetter Mechanism
2 Cap Open/Close Mechanism
3 Beads Mixer Mechanism
4 System Reagent Mechanism
5 Sipper Mechanism
6 Sipper Safety Cover
7 Syringe Mechanism
8 Gripper Mechanism
9 Solid Waste Mechanism
10 Reagent Disk Mechanism

Figure 4.2-2
1 BCR Mechanism
2 Cap Open/Close Mechanism
3 Reagent Disk Mechanism
4 Sample Disk Mechanism

Figure 4.2-3
1 Detection Mechanism
Figure 4.2-4
1 System Water Container

2 Liquid Waste Mechanism

4.2.2 Rack Sampler System
Figure 4.2-5 Rack Sampler Unit
1 C Line
2 BCR & BCR Board(P/N741-5056) in the Analyzer
3 STAT Sample Position
4 B Line
5 A Line

Figure 4.2-6 Overview of the A Line
1 LED201
2 PI202 (A Line Rack Feed End Position)
3 PI201 (A Line HOME Position)
4 PI200 (A Line Tray Detection)
5 Motor SM200

Figure 4.2-7 Overview of the B Line
1 PI213 (B Line STAT Position)

2 PI210 (B Line HOME Position)
3 PI216 (B Line BCR Read Position)
4 PI211 (B Line Rack Feed End Position)
5 PI212 (B Line Rack Detection)
6 PI217(B Line cup Detection)
7 PI215 (B Line Sampling Position)

Figure 4.2-8 Overview of the C Line
1 LED202
2 PI224 (C Line Tray Detection)
3 PI226 (C Line Tray Full 2 Detection)
4 PI225(C Line Tray Full 1 Detection)
5 PI223 (C Line Rack Full Detection)
6 Rack Feed Arm
7 PI222(C Line Rack Feed End Position)
8 PI221(C Line HOME Position)

4.3 List of Motors, Sensors, and Other Mechanisms
4.3.1 List of Motors

Table 4.3-1
No. Unit Type Part No. Drive PCB Control PCB
1 Sample Disk KP56KM1-014 741-0550 DO1 GPCONT1
2 Reagent Disk KH56LM2-027 741-0551 DO2 GPCONT1
3 Cap Open Close Mecha. (F/B) KH56HM2-016 741-4257 DO1 GPCONT2
4 Cap Open Close Mecha (O/C) PH264-01-C97 741-4255 DO1 GPCONT2
5 Beads Mixer (Rotation) PX244M-02A 741-0601 DO1 GPCONT3
6 Beads Mixer (U/D) KH42HM2-052 741-0603 DO1 GPCONT3
7 Beads Mixer (Mix.) 16CL-2524 741-0725 EIO3 GMCONT
8 Pipetter (X-axis) KH56LM2-027 741-4244 DO1 GPCONT5
9 Pipetter (U/D) KH42HM2-052 741-4245 DO1 GPCONT5
10 Gripper (X-axis) KH42JM2-011 741-4320 DO1 GPCONT7
11 Gripper (Y-axis) KH56LM2-049 741-4319 DO1 GPCONT8
12 Gripper (U/D) PF25-48D4 741-4321 DO1 GPCONT7
13 Gripper Solenoid 2ER45-33x3x9 741-4322 EIO3 GMCONT
14 Pipetter Syringe PH265M-33-C3 741-0804 DO1 GPCONT9
15 Sipper Syringe KH56KM2-016 741-0806 DO2 GPCONT9
16 Sipper (X-axis) KH56LM2-027 741-4248 DO1 GPCONT6
17 Sipper (U/D) KH42HM2-052 741-4249 DO2 GPCONT6
18 D Unit (Mag. Drive) KH42HM2-052 741-8551 DO2 GPCONT8
19 Solid Waste KH56HM2-016 741-0581 DO1 GPCONT4
20 BCR Rotate KH42HM2-052 741-0600 DO2 GPCONT4
4.3.2 Motor Reference List

This is a cross-reference list for motors used in the cobas e411 instrument. The part numbers in the
current pasts list mainly include motors with connected wires. Due to the fact that we only stock single
motors, the part numbers cannot be used for ordering purposes.
Table 4.3-2
Part number Part number
Page of Parts Part name
(motor with lead (motor itself, without
List (motor itself, without lead wires)
wires) lead wires)
8 741-0551 741-1120 Pulse Motor KH56LM2-027
11 741-4244 741-1120 Pulse Motor KH56LM2-027
13 741-4247 741-1049 Pulse Motor KH42HM2-052
20 741-4320 K591137 Pulse Motor KH42JM2-011
24 741-4319 741-3132 Pulse Motor KH56LM2-049
26 741-4257 741-1048 Pulse Motor KH56HM2-016
28 741-4248 741-1120 Pulse Motor KH56LM2-027
29 741-4251 741-1049 Pulse Motor KH42HM2-052
32 741-0806 741-1560 Pulse Motor KH56KM2-016
37 741-8551 741-1049 Pulse Motor KH42HM2-052
41 741-0603 741-1049 Pulse Motor KH42HM2-052
43 741-0600 741-1049 Pulse Motor KH42HM2-052
44 741-0581 741-1048 Pulse Motor KH56HM2-016
4.3.3 List of Sensors

Table 4.3-3
No. Item Description Type Part No. Bright/Dark
1 Photo-Coupler S.Disk Home P GP1A34LC J339165 Dark
2 Photo-Coupler S.Disk Stop P GP1A34LC ↑ Bright

No. Item Description Type Part No. Bright/Dark

3 Photo-Coupler R.Disk Home P GP1A34LC ↑ Dark
4 Photo-Coupler R.Disk Stop P GP1A34LC ↑ Bright
5 Photo-Coupler BCR Home P GP1A34LC ↑ Dark
6 Photo-Coupler Cap Opener F/B Home.P GP1A34LC ↑ Dark
7 Photo-Coupler Cap Opener F/B Stop.P GP1A34LC ↑ Dark
8 Photo-Coupler Cap Opener O/C Home P GP1A34LC ↑ Dark
9 Photo-Coupler Pipetter U/D UDP GP1A34LC ↑ Dark
10 Photo-Coupler Pipetter X-axis Home P GP1A34LC ↑ Dark
11 Photo-Coupler Pipetter X-axis End P GP1A34LC ↑ Dark
12 Photo-Coupler Pipetter Z-axis Abnormal D TLP830 J339168 Bright
13 Photo-Coupler Beads Mixer Arm Home P GP1A34LC J339165 Dark
14 Photo-Coupler Beads Mixer Arm End P GP1A34LC ↑ Dark
15 Photo-Coupler Beads Mixer U/D UDP GP1A34LC ↑ Dark
16 Photo-Coupler Solid Waste Home P GP1A34LC ↑ Dark
17 Photo-Coupler Solid Waste Box Det. DET-C 741-5026 Dark
18 Photo-Coupler Sipper U/D UDP GP1A34LC J339165 Dark
19 Photo-Coupler Sipper X-axis Home P GP1A34LC ↑ Dark
20 Photo-Coupler Sipper X-axis End P GP1A34LC ↑ Dark
21 Photo-Coupler Sipper Z-axis Abnormal D TLP830 J339168 Dark
22 Photo-Coupler Magnet Drive Home P GP1A34LC J339165 Dark
23 Photo-Coupler Pip. Syringe UDP DETECT1 741-0810 Dark
24 Photo-Coupler Sip Syringe UDP DETECT1 ↑ Dark
25 Photo-Coupler Gripper U/D UDP TLP830 J339168 Dark
26 Photo-Coupler Gripper X-axis Home P TLP830 ↑ Dark
27 Photo-Coupler Gripper Y-axis Home P TLP830 ↑ Dark
28 Photo-Coupler Gripper Y-axis End P TLP830 ↑ Dark
29 Photo-Coupler Gripper Y-axis Rest P TLP830 ↑ Dark
30 Photo-Coupler Gripper Solenoid Abnormal D TLP830 ↑ Dark
31 Photo-Coupler Gripper Solenoid Grip D TLP830 ↑ Bright
32 Photo-Coupler Waste Tank Detection GP1A34LC J339165 Bright
33 Photo-Coupler Waste Tank Full GP1A34LC ↑ Bright
34 Float Switch Distilled Water Level OLV-5-1 741-0563 -
35 Photo-Coupler Tip Buffer 1 PLI-523 741-4318 Dark
36 Photo-Coupler Tip Buffer 2 PLI-523 ↑ Dark
37 Photo-sensor System Reagent Bottle EE-Spy412 741-1385 Presence
38 Thermistor R.Disk Temp. Control - 741-0554 -
39 Thermistor Incubator Temp Control - 741-0582 -
40 Thermistor D.Unit Temp. Control - 741-8551 -
41 Thermistor S.Reagent Temp Control - 741-0548 -
42 Photo-Coupler Sipper Safety Cover DET-C 741-5026 Dark
4.3.4 List of Peltier, Heater and Fan Motor

Table 4.3-4
No. Item Application Type Parts No. Voltage
1 Peltier Reagent Disk Jacket EC-50FH 741-1216 ±15V
2 Peltier Reagent Disk Jacket EC-50FH ↑ ↑
3 Peltier System Reagent EC-50FL 741-1202 ↑
4 Peltier Detection Unit EC-50FL ↑ ↑
5 Fan Motor Reagent Disk Jacket 109P0912H402 741-1216 12V
6 Fan Motor Reagent Disk Jacket 109P0912H402 ↑ ↑
7 Fan Motor System Reagent 0915-12 741-1202 ↑
8 Fan Motor Detection Unit 0915-12 ↑ ↑
9 Fan Motor PCB Rack 109P1212H402 L542164 ↑
10 Fan Motor Cooling of Instrument 109P1212H402 ↑ ↑
11 Fan Motor Cooling of Instrument 109P1212H402 ↑ ↑
12 Heater Incubator SD-124--520 J864036 ↑

4.3.5 List of Motors for Rack Sampler System

No. Unit Type Part No. Drive PCB Control PCB
1 A Line C7640-9212K 741-7258 DO4A GPCONT12
2 B Line KP56KM1-014 K591127 DO4A GPCONT13
3 C Line A3339-9212 K591271 DO4A GPCONT12
4.3.6 List of Sensors for Rack Sampler System

No. Item Description Type Parts No. Bright/Dark
1 Photo-Coupler PI200 A Line Tray Detection PM2-LF10HH J684019 Dark
2 Photo-Coupler PI201 A Line Home Pos. GP1A34LC J339165 Dark
3 Photo-Coupler PI202 A Line Rack Feed End Pos. GP1A34LC ↑ Dark
4 Photo-Coupler PI210 B Line Home Pos. GP1A34LC ↑ Bright
5 Photo-Coupler PI211 B Line Rack Feed End Pos. GP1A34LC ↑ Dark
6 Photo-Coupler PI212 B Line Rack Detection PM2-LF10HH J684019 Dark
7 Photo-Coupler PI213 B Line STAT Pos. GP1A34LC J339165 Dark
8 Photo-Coupler PI215 B Line Sampling Pos. PH-D 741-5053 Bright
PH-T 741-5054
9 Photo-Coupler PI216 B Line BCR Read Pos. GP1A34LC J339165 Dark
10 Photo-Coupler PI217 B Line Cup Detection PM2-LF10HH J684019 Dark
11 Photo-Coupler PI221 C Line Home Pos. GP1A34LC J339165 Dark
12 Photo-Coupler PI222 C Line Rack Feed End Pos. GP1A34LC ↑ Dark
13 Photo-Coupler PI223 C Line Rack Full Detection PM2-LF10HH J684019 Dark
14 Photo-Coupler PI224 C Line Tray Detection PM2-LF10HH ↑ Dark
15 Photo-Coupler PI225 C Line Tray Full(1) Detection PM2-LF10HH ↑ Dark
16 Photo-Coupler PI226 C Line Tray Full(2) Detection PM2-LF10HH ↑ Dark
4.3.7 List of LEDs and Fan Motor for Rack Sampler System
No. Item Description Type Parts No. Voltage
1 LED201 A Line Tray Exchange BD-703G J853635 5V
2 LED202 C Line Tray Exchange BD-703G ↑ 5V
3 Fan Motor Cooling of DC Power Supply MD825BM-24 L542069 24V

Note: Part No. and Part name of each mechanism are different depending on the manufacturing
time. Please refer to Parts List for details.
4.4.1 Sample Disk Drive Mechanism
4.4.1.1 Overview
The sample disk drive mechanism is a unit that activates the rotation movement of sample disk
and transfers samples to the pipetting position.
4.4.1.2 Location
See Chapter 4.2.
4.4.1.3 Function Explanation Details
This unit consists of the following parts:
• Sample Disk
• Rotation Mechanism
Sample Disk
The sample disk can have positions for thirty (30) samples and controls and be removed from the
device in a single operation. Upon delivery, the Sample Disk is wrapped independently from the
main body as an accessory.
Suitable test tubes for the sample disk:
• Φ13mm x 75 mm
• Φ13mm x 100 mm
• Φ16mm x 75 mm
• Φ16mm x 100 mm
Suitable sample cups for the sample disk:
• HITACHI sample cup
The 2~3 ml calibrator bottle can be used for the sample disk.
Table diameter: Φ219 mm,Table height: 100 mm
Rotation Mechanism

The rotation mechanism is a mechanism activated by the timing belt and the motor that activates
the rotation movement of the sample disk.
• Speed reduction comparison: 1:10

• Step angle after speed reduction: 0.045º
4.4.1.4 Explanatory Diagram
Figure 4.4-1

Figure 4.4-2

Figure 4.4-3

4.4.1.5 Parts List
Table 4.4-1
Pos. No. Part Name Part No.

1 MOTOR S ASSY 741-0550
2 SPRING S ASSY 741-0556
3 PULLEY ASSY 741-0639
4 BASE 741-1185
5 TIMING BELT SR 741-1211
6 HOLDER 2 741-2158
7 GND RING R 741-2159
8 SPRING 741-2166
9 CORD J511 741-4300
10 SENSOR GP1A34LC J339165
11 WIRE BINDER TY-23M J839050
13 BALL BEARING 6002ZZ L111060
14 PULLEY L237010
4.4.1.6 Disassembly and Assembly Procedures
Removing the units
Remove the parts in the following order:
1 ► Remove waste tank and water supply tank.

2 ► Take out the R lid, reagent disk, and sample disk.
3 ► Take out cover Y (side cover of the gripper).
4 ► Take out rear cover.
5 ► Take out front cover.
6 ► Take out table cover.
7 ► Unscrew the M4 screw that press-fixes the GND stopper (S) assembly.
8 ► Remove the sample jacket.
9 ► Remove the connectors (J510 and J511) and the GND wire.
10 ► Pull out the sample disk drive unit.
Disassembly and Assembly of Unit
Rotation Motor

Disassembly
1 ► Remove the motor
• Unscrew the M4 Screw that secures the motor.
Assembly
1 ► Temporarily fix the motor with the M4 screw, and put the timing belt on the small pulley
for the motor.
2 ► Put the timing belt SR on the big pulley, then rotate the pulley by a small amount (2 or 3
teeth) in either direction to ensure a solid fit.
3 ► Adjust the belt tension. The belt tension is indicated in the figure below.
Figure 4.4-4
Big Pulley
Disassembly
When removing the big pulley, remove it before dismounting the unit from the main body.

2 ► Detach the center holder 2.
3 ► Take out the GND ring and GND spring 1.
4 ► Remove the timing belt SR.
5 ► Pull out the big pulley (the small bearing does not need to be removed.).
• Support the outer circumference by hand
Assembly
Assemble after dismounting the motor for rotation.
1 ► Put the big pulley horizontally on the bearing, and push firmly to set.
2 ► Insert the small bearing, GND spring, GND ring, and center holder 2 sequentially and fix
with the screw.
3 ► Install the rotation motor.
4 ► Adjust the belt tension as described above.
Home Position Sensor and Position Sensor

Disassembly
1 ► Pull out the big pulley.

2 ► Unhook the hook of the sensor from the back of the unit.
3 ► Pull out the connector of the sensor.
Assembly
1 ► Insert the sensor and install the connector.

2 ► Install the big pulley.
3 ► Mount the rotation motor.
4.4.1.7 The Motion and Motion Check Method
Check the motion via Reset Motion and confirm that Position No. 1 stops at the sampling position.
4.4.2 Reagent Disk Drive Mechanism
4.4.2.1 Overview
The reagent disk drive mechanism is a unit that activates the rotation movement of reagent disk
and transfers reagents to the pipetting positions.
4.4.2.2 Location
See Chapter 4.2.
4.4.2.3 Functional Details
• Reagent Disk
1. Reagent Disk
The reagent disk can be used to set more than eighteen (18) reagent rack packs on the
circumference. On delivery, the reagent disk is packaged independently from the main body as
an accessory.
2. Rotation Mechanism
The rotation mechanism is activated by the timing belt and the motor that activates the rotation
movement of the reagent disk.

• Step angle after speed reduction: 0.18° / step (during operation), 0.0225° / step (during
initialization)

Figure 4.4-5
Figure 4.4-6

4.4.2.5 Parts List

1 Base 741-1185
2 Pulley Assy 741-0639
3 Holder 1 741-1193
4 Ring 741-1197
5 Spring 1 741-1195
6 Spring R Assy 741-0557
7 Ball Bearing 6002ZZ L111060
8 Timing Belt SR 741-1211
9 Pulley L237010
10 Sensor GP1A34LC J339165
11 Motor R Assy 741-0551
12 Cord J521 741-4301
13 Rubber Washer 707-2007
14 Washer R 741-1217
15 Clamp CKS-05-H J839408
16 Set Plate 741-0598
17 R Disk Assy 741-0627
18 Lock Knob 741-1199
Removing the Units

6 ► Take out table cover L and table cover R.
7 ► Remove the set plate.
8 ► Remove the reagent cooler unit.
• Take out connectors J520, J521, and the GND wire.
9 ► Dismount the reagent disk drive unit.

Note: Part No. and Part name of each mechanism are different depending on the manufacturing
time. Please refer to Parts List for details.
4.4.1 Sample Disk Drive Mechanism
4.4.1.1 Overview
The sample disk drive mechanism is a unit that activates the rotation movement of sample disk
and transfers samples to the pipetting position.
4.4.1.2 Location
See Chapter 4.2.
• Sample Disk
Sample Disk
The sample disk can have positions for thirty (30) samples and controls and be removed from the
device in a single operation. Upon delivery, the Sample Disk is wrapped independently from the
main body as an accessory.
Suitable test tubes for the sample disk:
• Φ13mm x 75 mm
• Φ13mm x 100 mm
• Φ16mm x 75 mm
• Φ16mm x 100 mm
Suitable sample cups for the sample disk:
• HITACHI sample cup
The 2~3 ml calibrator bottle can be used for the sample disk.
Table diameter: Φ219 mm,Table height: 100 mm

Rotation Mechanism
The rotation mechanism is a mechanism activated by the timing belt and the motor that activates
the rotation movement of the sample disk.

• Step angle after speed reduction: 0.045º
Figure 4.4-1

Figure 4.4-2

Figure 4.4-3

4.4.1.5 Parts List
Table 4.4-1

1 MOTOR S ASSY 741-0550
2 SPRING S ASSY 741-0556
3 PULLEY ASSY 741-0639
4 BASE 741-1185
5 TIMING BELT SR 741-1211
6 HOLDER 2 741-2158
7 GND RING R 741-2159
8 SPRING 741-2166
9 CORD J511 741-4300
10 SENSOR GP1A34LC J339165
13 BALL BEARING 6002ZZ L111060
14 PULLEY L237010
Removing the units

6 ► Take out table cover.
7 ► Unscrew the M4 screw that press-fixes the GND stopper (S) assembly.
9 ► Remove the connectors (J510 and J511) and the GND wire.
10 ► Pull out the sample disk drive unit.

Rotation Motor
Disassembly
• Unscrew the M4 Screw that secures the motor.
Assembly
for the motor.
2 ► Put the timing belt SR on the big pulley, then rotate the pulley by a small amount (2 or 3
teeth) in either direction to ensure a solid fit.
Figure 4.4-4
Big Pulley
Disassembly

2 ► Detach the center holder 2.
5 ► Pull out the big pulley (the small bearing does not need to be removed.).
• Support the outer circumference by hand
Assembly
Assemble after dismounting the motor for rotation.
1 ► Put the big pulley horizontally on the bearing, and push firmly to set.
with the screw.

4 ► Adjust the belt tension as described above.
Disassembly

Assembly

Check the motion via Reset Motion and confirm that Position No. 1 stops at the sampling position.
4.4.2 Reagent Disk Drive Mechanism
4.4.2.1 Overview
The reagent disk drive mechanism is a unit that activates the rotation movement of reagent disk
and transfers reagents to the pipetting positions.
4.4.2.2 Location
See Chapter 4.2.
• Reagent Disk
1. Reagent Disk
The reagent disk can be used to set more than eighteen (18) reagent rack packs on the
circumference. On delivery, the reagent disk is packaged independently from the main body as
an accessory.
2. Rotation Mechanism
The rotation mechanism is activated by the timing belt and the motor that activates the rotation
movement of the reagent disk.


• Step angle after speed reduction: 0.18° / step (during operation), 0.0225° / step (during
initialization)
Figure 4.4-5

Figure 4.4-6
4.4.2.5 Parts List

1 Base 741-1185
2 Pulley Assy 741-0639
3 Holder 1 741-1193
4 Ring 741-1197
5 Spring 1 741-1195
6 Spring R Assy 741-0557
7 Ball Bearing 6002ZZ L111060
8 Timing Belt SR 741-1211
9 Pulley L237010
11 Motor R Assy 741-0551


12 Cord J521 741-4301
13 Rubber Washer 707-2007
14 Washer R 741-1217
15 Clamp CKS-05-H J839408
16 Set Plate 741-0598
17 R Disk Assy 741-0627
18 Lock Knob 741-1199
Removing the Units

7 ► Remove the set plate.
8 ► Remove the reagent cooler unit.
• Take out connectors J520, J521, and the GND wire.
9 ► Dismount the reagent disk drive unit.
Rotation Motor
Disassembly
• Unscrew the M4 screw that secures the motor.
Assembly
for the motor.
2 ► Put the timing belt SR on the big pulley, and turn the pulley a small amount (2 or 3
teeth) in either direction to ensure a solid fit .

Figure 4.4-7
Big Pulley
Disassembly
1 ► Remove center holder 1.

• Support the outer edge by hand. (The small bearing does not need to be removed.)
Assembly
Assemble after dismounting the rotation motor.
1 ► Put the big pulley horizontally on the bearing and insert it firmly.
with the screw.
4 ► Adjust the belt tension.
Disassembly

Assembly

Check the motion via Reset Motion and confirm that Position No.1 stops at the Cap O/C position.

4.4.2.8 Reagent Cooler Unit
Overview
The reagent cooler unit is a reagent-temperature control unit by Peltier element.
Location
See Chapter 4.2.
Functional Details
• Peltier cooling unit

• Copper jacket part
• R. lid (cover at the top part)
• Window section to read bar code
• R. lid O/C sensor part
1. Peltier Cooling Unit
The Peltier cooling unit consists of a Peltier element, cooling fin, and DC fan. It maintains the
reagent temperature at 20°C ± 3°C using two (2)sets.
2. Copper Jacket Part
The copper jacket part consists of a pot-shaped copper jacket and insulating material that covers
the round copper plate (THK: 5mm) and maintains a constant internal temperature.
3. R. Lid
The R. lid prevents temperature increases via the top of the reagent cooler unit.
4. Window Section to Read Bar Code
This window allows the labels on reagent bottles to be read by the two-dimensional bar-code
reader. The heater prevents condensation.
5. R. Lid O/C Sensor Part
The R. lid O/C Sensor part detects opening/closing of the R lid via a microswitch.

Explanatory Diagram
Figure 4.4-8
Parts List
Pos. No. Part Name Part No

1 THERMISTOR R ASSY 741-0554
2 COVER SW ASSY 741-0555
3 MICRO-COOLER S3 ASSY 741-0750
4 INNER RING 741-1188
5 CUP 741-1190
6 TEMP JACKET 741-1200
7 PACKING 741-1210
8 PLATE 741-1219

Pos. No. Part Name Part No

9 BUSH B 741-1383
10 OUTER RING 741-8507
11 PACKING S 768-3116
Disassembly and Assembly Procedures
Removing the Units
Remove the parts in the following order (start with covers):

7 ► Remove P plate cover.
8 ► Take out the following connectors: J523, J524, and J525.
9 ► Remove set plate.
10 ► Dismount reagent cooler unit.
Disassembly and Assembly of Units
• Microcooler assembly
• Thermistor R assembly
• Outer ring, inner ring
• Window heater
• R. lid
1. Microcooler Assembly
Disassembly
1 ► Take out the two (2) packing S.

2 ► Unscrew the two (2) screws of the thermostat.
3 ► Remove the J523 connector.
4 ► Pull out #3 and #6 pins (for window heater) of J523 connector.
• Use tweezers to pull out the pins.
5 ► Release two (2) microcoolers.

Assembly
1 ► Apply a thin coat of silicone grease (heat-conducting) to the cooling surface of the
microcooler.
2 ► Fix the two (2) microcoolers evenly using screws.
3 ► Push the pins for window heater to #3 and #6 of J523 connector (no polarity in the
window heater).
4 ► Assemble the thermostat, packing S, and J523 connector.
2. Thermistor R. Assembly
Disassembly
1 ► Remove the microcooler assembly.

2 ► Take out insulation cup.
3 ► Remove thermistor R assembly.
Assembly
To assemble the thermistor R assembly, re-install the parts removed during disassembly
procedures (see above) in the reverse order.
3. Outer Ring, Inner Ring
Disassembly
1 ► Dismount the microcooler assembly.

3 ► Remove thermistor R assembly.
4 ► Remove outer ring and inner ring.
Assembly
To assemble the outer ring and inner ring, re-install the parts removed during disassembly
procedures (see above) in the reverse order.
4. Window Heater
Disassembly
1 ► Remove the microcooler assembly.

3 ► Remove thermistor R. assembly.
4 ► Remove outer ring.
5 ► Remove the heater holder.
6 ► Remove window heater.

Assembly
To assemble the window heater, re-install the parts removed during disassembly procedures (see
above) in the reverse order.
5. R. Lid
Disassembly
1 ► Pull out the lock knob.
Assembly
1 ► Apply a very thin coat of silicone grease (heat-conducting) to the tip of the lock knob.
2 ► Push and insert the hold rubber in the R. lid.
3 ► Turn the lock knob to insert it into the R. lid.
4.4.3 Cap Open/Close Mechanism
4.4.3.1 Overview
The cap open/close mechanism is a unit that opens/closes the snap cap of RackPacks according
to the timing of beads stirring or reagent pipetting by means of three (3) independent hooks.
4.4.3.2 Location
See Chapter 4.2.
• Rotation mechanism
• Front-rear mechanism
• RackPack stopper
Rotation Mechanism
The rotation mechanism activates three (3) hooks to start rotation movement to open the cap.
The rotation mechanism constitutes the crank mechanism with the fork link that rotates around
the center of a spinning fulcrum of hook and the drive link installed to the motor shaft with speed
reduction control. The three (3) hooks are installed in a special manner:
1. The hooks are attached to the hook plate by a coil spring.

2. Each hook can independently work on the hook-plate that moves following the motion of fork
link.
Speed reduction comparison: 1:10

Step angle after speed reduction: 0.18° / step
Stroke: 51.1° / step
Front-Rear Mechanism
The front-rear mechanism activates the rotation mechanism in a front-rear movement. It

constitutes the straight-line movement mechanism by the timing belt and the stepping motor
installed at the base of the unit.
Step angle: 0.9°

Stroke: 113 mm
RackPack Stopper
The RackPack stopper is a rod-shaped mechanism that initiates front-rear movement at the same
time as the rotation mechanism part executes front-rear movement. Upon opening the cap, the
RackPack stopper prevents the rack pack from rising.
Stroke: 58.2mm

Figure 4.4-9
4.4.3.5 Parts List

1 Pulse Motor Assy 741-4257
2 Pulse Motor PH264-C97 Assy 741-4255
3 Gear Head H0051-122 741-1262
4 Pulley 5M 741-1121
5 Timing Belt 741-1267

Removing and Mounting of Unit
If removing from the front cover.
Removal:
1 ► Remove the following covers:
• Rear cover
• R. lid
• Y cover
• Front cover assembly
• Table cover R
• Table cover L
2 ► Take out R. disk.
• See 4.4.2.
3 ► Dismount the unit with base sheet assembly.
• Unscrew the two (2) M4 x 6 screws.
4 ► Remove the unit from the base sheet assembly.
• Unscrew the two (2) M4 x 6 screws.
Mounting
Mount the units by re-installing the parts removed during the removal procedures (see above) in
the reverse order.
If removing from the rear cover
Removal
1 ► Remove the rear cover.

2 ► Dismount the unit.
• Unscrew the M4 x 6 screw.
Mounting
Assemble the units by re-installing the parts removed during the removal procedures (see above)
in the reverse order.
Disassembly and Assembly of Units
• Rotation mechanism

• Front-rear mechanism
1. Rotation mechanism (link mechanism assembly)
Disassembly
1 ► Unscrew the M4 x 6 screws that fix the clamp on the plug (J532) side.
2 ► Remove the tie wraps that fix the CAP O/C cord assembly and the J532 cord assembly.
3 ► Take out the P532 socket.
4 ► Dismount the photo interrupter (PI033) and the cord together.
• You can replace the photo interrupter (PI033) by removing the connector.
5 ► Detach the E-type fix ring 4 located at the tip of the rear part of the RackPack stopper
assembly.
6 ► Pull out the RackPack stopper assembly. Do not misplace the dumping spring.
7 ► Detach the E-type fix ring 6 attached to the inside of the cap open/close mechanism
base from the two (2) slick shafts.
8 ► Support the link mechanism assembly and pull out the two (2) slick shafts.
9 ► Remove the timing belt from the motor bracket.
10 ► Unscrew the two (2) M4 x 4 point screws that fix the link pin assembly.
11 ► Pull out the J532 cord assembly.
• Unscrew four (4) M4 x 40 screws.
12 ► Remove speed reduction control H0051.
Assembly
1 ► Assemble the unit by re-installing the parts removed during the disassembly procedure
(see above) in the reverse order.
2 ► Fix the link assembly by adjusting bearing to fork link assembly.
2. Front-Rear Mechanism
Disassembly
1 ► Unscrew the two (2) M4 x 6 screws that fix the pulley base.
2 ► Remove the timing belt from the motor bracket.
3 ► Detach one (1) E-type fix ring 4 from the pulley shaft (See Figure**), and remove pulley
S5M and timing belt.
4 ► Remove the photo interrupters (PI031, PI032) and the cord together.
• You can replace the photo Interrupters (PI031, PI032) by removing the connector.
5 ► Unplug plugs (J530, J531) from the cap open/close mechanism base.
6 ► Unscrew the two (2) M4 x 6 screws that fix the clamp.
7 ► Take out the tie wraps that fix the CAP O/C cord assembly and the J532 cord assembly.

8 ► Remove P532 socket.

9 ► Remove the photo interrupter (PI033) and the cord together.
• You can replace the photo interrupter (PI033) by removing the connector.
10 ► Pull out the cord from the clamp that fixes the cord.
11 ► Unscrew the two (2) M4 x 16 screws that fix stepping motor KH56.
12 ► Unscrew two (2) M4 x 4 W point screws, and remove pulley S5M.
Location of PCP
Figure 4.4-10
1 Open/Close HOME PCP

2 F/B HOME PCP
3 F/B STOP PCP
4.4.4 Beads Mixer Mechanism
4.4.4.1 Overview
The beads mixer mechanism is a mechanism that stirs the beads inside the reagent rack pack
immediately before the pipetting of the reagent.
4.4.4.2 Location
See Chapter 4.2.
The beads mixer mechanism consists of the following components:
• Stirrer head vertical movement mechanism

• Stirrer head rotating mechanism

• Stirring paddle rotating mechanism
Stirrer Head Vertical Movement Mechanism
The Stirrer Head Vertical Movement Mechanism moves the stirring paddle up and down over the
RackPack with its cap open and over the wash bath. The stirrer head that supports the stirring
paddle and the vertical movement mechanism are vertically connected with an arm pipe. A nut
holder and slide guide that are installed on the inner and outer rings of the ball bearings are
installed in the vertical movement mechanism. A spline nut is inserted in the nut holder. The slide
guide and the nut holder shift up and down guided by the spline shaft and guide shaft; the slide
guide stops the rotation and the vertical movement, and the nut holder controls the rotation
triggered by the rotation of the spline shaft and makes vertical movement.
Pulleys are positioned above and below the moving parts keeping a sufficient axle distance from
the stirring paddle so that they will not contact with each other when the stirring paddle makes
strokes. The slide guide, which is hooked up to the timing belt, is moved vertically, driven by the
stepping motor.
Slow down rate 1:1
Motor step angle 0.9°/step
Shift range 0.1 mm/step
Stirrer Head Rotating Mechanism
A nut holder is fixed on the inner ring of the ball bearings and a slide guide on the outer ring. An
arm pipe that secures the stirrer head is fixed to the nut holder. The ball bearings guide the arm
pipe and nut holder to swing together within a range limited by the stopper that is installed on the
slide guide.
Driven by the stepping motor, the moving parts cause rotation of the pulley that is attached to the
bottom of the spline shaft. The rotating force is conveyed to the pulley via the timing belt.
Slow down rate 1:1
Motor stepping angle 0.45°/step
Shift range 0.235 mm/step

Stirring Paddle Rotating Mechanism
The stirring paddle rotating mechanism is driven by a DC motor and its pulley causes the rotation
of the pulley that is attached to one end of the stirring paddle. The rotating force is conveyed to
the rotation pulley via the rectangular elastic belt connected to it.
Slow down rate 1:1
Applied voltage 4.8 V (adjustable)
Rotation 2050 ± 100 rpm in air
2000 ± 100 rpm in liquid (refer to Chapter 5.3.8

for details)
Figure 4.4-11

4.4.4.4 Parts List

1 Frame 741-1220
2 Guide 741-1221
3 Holder 741-1222
4 Arm 741-0576
5 Ball Bearing 6804ZZ 741-1244
6 Spline L142042
7 Guide Shaft 741-1224
8 Timing Belt M 741-1243
9 Pulley S 741-0549
10 Motor Z Assy 741-0603
11 Motor M Assy 741-0601
12 Timing Belt S(Z) 741-1338
13 Arm Head 2 741-8552
14 Arm Cover 2 741-8554
15 Pulley 2 741-1461
16 Shaft A 741-1234
17 Ball Bearing DDRFW-830ZZ L111270
18 Joint 2 741-3050
19 Belt 741-2244
20 Mixing Motor 741-0725
21 Dish 741-1230
22 Mixing Paddle With Screw 741-0934
23 W Point Screw M731021
24 Snap Ring E IN 2 SUS304 M883003
25 CordJ541* *Refer to Chapter 10, 741-4303
Maintenance
Removing the Beads Mixer Unit
First remove the reagent disk mechanism (see Chapter 4.4.2.6). After removing the reagent disk,
unscrew three (3) screws, two (2) connectors (P540 and P541), and one (1) grounding terminal
set screw to remove the beads mixer unit from the main unit base.

Disassembly and Assembly of the Beads Mixer Unit
• Stirrer head vertical movement / rotating mechanism

• Moving parts
• Stirring arm head
1. Stirrer Head Vertical Movement / Rotating Mechanism
Disassembly Procedure
1 ► Remove the stirrer arm head from the arm pipe.
► Take out the head cover and pull out the DC motor wiring connector pin inside.
► Unscrew two (2) W point screws on the side of the stirrer arm head.
2 ► Pull out the guide shaft.
► Remove two (2) E rings.
3 ► Remove the mechanism that is installed in the spline hut and the ball spline shaft
together.
► Remove two (2) E rings.

► Unscrew two (2) W point screws on the timing pulley.
► Unhook the belt off the belt hook of the slide guide.
► Lift the spline shaft with the bearings on its top by about 20 mm and remove the spline
shaft from the timing pulley.
► Remove the spline shaft and spline nut mechanism by pulling them downward. Note: Be
careful not to pull the spline nut mechanism off the shaft.
4 ► Remove the slide guide.
► Remove the C ring.
5 ► Remove the nut holder.
► Remove the four (4) screws from the spline nut.
6 ► Remove the lead wire and grounding wire from the DC motor.
► To remove the lead wire from the DC motor, disconnect the connector terminal from
connector J541 and pull the wire through the arm pipe.
► To remove the grounding wire, remove the screw from the terminal attached to the hut
holder and remove the wire from the O ring.
Assembly Procedure
Assemble the mechanism by re-installing the parts removed during the disassembly procedure

2. Moving Parts (Vertical, Rotating)
1 ► Remove the stepping motor.
► Remove the two (2) screws.
2 ► Remove the timing belt.
Assembly Procedure
Assemble the moving parts by re-installing the parts removed during the disassembly procedure
Adjusting the Belt Tension
► Adjust the belt by sliding the stepping motor (see Figure 4.4-12, Adjustment of Belt
Tension).
3. Stirrer Arm Head
1 ► Remove the stirrer belt (a rectangular elastic belt) from the pulley.
2 ► Remove the mixing motor assembly.
► Unscrew the two screws that secure the motor plate.
3 ► Remove the stirring paddle.
► Loosen the bottom parts of the two W point screws of the joint.
4 ► Pull out the stirrer pulley and shaft from the bearings.
► Loosen the top parts of the two W point screws of the joint and remove them.
► Remove the E ring.
Assembly Procedure
Assemble the stirrer arm head by re-installing the parts removed during the disassembly
procedure (see above) in the reverse order.

Figure 4.4-12 Adjustment of Belt Tension
Location of PCP
Figure 4.4-13

4.4.5 Pipetter Mechanism
4.4.5.1 Overview
The pipetter mechanism is a mechanism that picks up disposable tips and pipettes sample,
calibrator, reagent (beads, R1, R2 and diluent, etc.) into the reaction vessel by means of an X-Z
moving mechanism.
4.4.5.2 Location
See Chapter 4.2.
The pipetter mechanism consists of the following components:
• X-Axis movement mechanism

• Z-Axis movement mechanism
• Tip/Vessel buffer
• Pressure (clot) sensor
X-Axis Movement Mechanism
The X-axis movement mechanism moves the pipetter probe to each sampling position and
replaces the disposable tip. The X-axis movement mechanism drives Z-axis mechanism that is
mounted on the timing belt with a stepping motor.
Z-Axis Movement Mechanism
The Z-axis movement mechanism moves the pipetter probe and disposable tip to each sampling
height position, and drives the nozzle head that is mounted on the timing belt with a stepping
motor via the LM guide.
Tip/Vessel Buffer
• The tip/vessel buffer is the area where the gripper places the disposable tips and the reaction
vessels so that the pipetter probe has access to them.
• There are sensors in the first two positions to detect the presence of a tip; the gripper
mechanism also checks the tip and vessel placement
• The tip eject position is at the edge of tip/vessel buffer.
Pressure (Clot) Sensor
This detects clots in sample, calibrator, reagent or diluent during piping by monitoring pressure
changes inside the tube.

Figure 4.4-14

Figure 4.4-15
4.4.5.5 Parts List
Table 4.4-2

1 Cord FPC P 741-4503
2 Motor X Assy 741-4244
3 Cord P557 741-4247
4 Circuit Board Assy LLD-P3 741-5048
5 Timing Belt P (X) 741-1062
6 Timing Belt P (Z) 741-1063
7 P Nozzle Box 3 Assy 741-8820


8 Circuit Board Assy DIST-PA 741-5045
11 Tube 510 741-1778
12 Tube 465 741-1775
13 P-Sensor 2 Assy 741-2267
14 Twin Detector Assy 741-4318
Note: Shape of the tip of P.Nozzle is different between E2010 and e411. In addition, shape of the
tip of e411 P.Nozzel is similar to E170 P.Nozzle. But internal structure is different
Figure 4.4-16
1. Removing the Pipetter Mechanism
► Remove the rear cover.

► Remove cover Y from gripper.
► Remove the reagent disk cover.
► Remove the table cover L.
► Remove the front cover.
► Remove the connector of the pressure sensor.
► Remove the syringe tube of pressure detecting part.
► Unscrew the screw fixing the pipetter mechanism.
2. Disassembly and Assembly of each Unit

1) X-axis movement mechanism
2) Z-axis movement mechanism
3) FPC cable
4) Tube
5) Photo interrupter
6) Pressure (clot) sensor

7) Tip/vessel buffer
X-Axis Movement Mechanism- - - - - - -Replacement of Motor and Timing Belt
► Remove the fixing screw which is located on the right side of center cover.
► Remove the motor bracket and X pulley from P side base.
► Remove the timing belt.
Assembly Procedure
► Assemble in reverse order of disassembly procedure (see above).

► Adjust the timing belt tension.
Tension : Press middle of the timing belt with a vertical force of 2±0.5 N, then adjust pulley
position by loosening the X pulley screw as shown in the diagram below.
Figure 4.4-17
Z-Axis Movement Mechanism - - - - - - -Replacement of Motor and Timing Belt.
► Remove the P carrier cover.

► Remove the Z-axis stepping motor.
Assembly Procedure
► Adjust the timing belt tension.
Tension: Push middle of the timing belt with a vertical force of 1.5±0.3 N, then adjust motor
position by loosening the motor fixing screw as shown in the diagram below.
Figure 4.4-18

Disassembly Procedure for Z-Axis Photo Interrupter
► Remove the photo interrupter from the bracket of the Z-axis movement unit, and pull out
to the side.
Assembly Procedure
Disassembly Procedure of Probe Abnormal Descent Photo Interrupter
► Refer to FPC cable disassembly procedure.
Assembling Procedure
► Refer to FPC Cable assembly procedure.
Pressure (Clot) Sensor (X Axis, Z Axis, Probe Abnormal Detection)
► Loosen the screw of the driver base.

► Remove the pressure sensor cable from ANG-EP PCB and the rear cover of the
pipetter mechanism.
► Remove the rear cover of the pipetter mechanism.
► Disconnect the pressure sensor from the tube joint, and put cap or cover on the top.
Note: Do not touch the top of the screw part of the pressure sensor with your fingers.
Assembly Procedure
► Attach about 70mm spiral tube onto the pressure sensor cable.
► Remove cap or cover from top of the pressure sensor.
► Put seal packing on the screw part of the pressure sensor, and attach to the tube joint.
► Mount the rear cover of the pipetter mechanism.
► Fix the spiral tube part of the pressure sensor cable taking care not to catch the cable in
the open close mechanism.
► Fix the pressure sensor cable to the rear cover.
► Connect the cable to ANG-EP PCB.
► Tighten the screw of the driver base.
FPC Cable
► Remove the PK cover.

► Remove the FPC cable from PCB.

► Pull out the FPC cable from the Z-axis movement unit.
► Remove the P arm cover.
► Pull out FPC holder.
► Remove PCB from the P arm, and pull out the FPC cable from the PCB.
Assembly Procedure
Tube (L1=465, L2=510)
Disassembly Procedure for L1
► Remove the P arm cover.

► Disconnect the tube nipple from the probe.
Assembly Procedure
► Attach the tube nipple to the probe. (tightening torque is 2.5 kgf·cm).
► Tubing as original.
► Confirm that P arm moves smoothly without catching.
Disassembly Procedure for L2
► Remove P plate.
► Cut the tie-wrap tube clamping.
► Disconnect the tube nipple the tube joint.
Assembly Procedure
► Attach the tube nipple to the tube joint.

► Fix the tube with tie-wrap.
► Move the Z-axis movement unit to the left and right and confirm that the tube does not
come out from between the tube guide and the rear cover.
Photo Interrupter (X Axis, Z Axis, Probe Abnormal Detection)
Disassembly Procedure for X-Axis Photo Interrupter
► Remove the bracket of the photo interrupter from left and right of pipetter mechanism
side frame.
► Disconnect the connector.
► Remove the photo interrupter from bracket.

Assembly Procedure
Disassembly Procedure for Z-Axis Photo Interrupter
► Remove the photo interrupter from the bracket of the Z-axis movement unit, and pull out
to the side.
Assembly Procedure
Disassembly Procedure of Probe Abnormal Descent Photo Interrupter
► Refer to FPC cable disassembly procedure.
Assembling Procedure
► Refer to FPC Cable assembly procedure.
Pressure (Clot) Sensor (X Axis, Z Axis, Probe Abnormal Detection)
► Loosen the screw of the driver base.

► Remove the pressure sensor cable from ANG-EP PCB and the rear cover of the
pipetter mechanism.
► Remove the rear cover of the pipetter mechanism.
► Disconnect the pressure sensor from the tube joint, and put cap or cover on the top.
Note: Do not touch the top of the screw part of the pressure sensor with your fingers.
Assembly Procedure
► Attach about 70mm spiral tube onto the pressure sensor cable.
► Remove cap or cover from top of the pressure sensor.
► Put seal packing on the screw part of the pressure sensor, and attach to the tube joint.
► Mount the rear cover of the pipetter mechanism.
► Fix the spiral tube part of the pressure sensor cable taking care not to catch the cable in
the open close mechanism.
► Fix the pressure sensor cable to the rear cover.
► Connect the cable to ANG-EP PCB.
► Tighten the screw of the driver base.

4.4.5.7 Procedure for exchanging TUBE 465
TUBE 465
How to remove TUBE 465
1 ► Remove two (2) screws A from PR cover (refer to Figure 4.4-20).

2 ► Move P carrier to the left end, and remove TUBE 465 from tube joint 2 (refer to Figure
4.4-23).
3 ► Remove the P arm cover, and remove tube holder from both the P arm cover and the P
arm internal cover (refer to Figure 4.4-25).
4 ► Remove TUBE 465 from P nozzle (refer to Figure 4.4-25). Be careful not to lose the
nozzle seal between the nipple and the P nozzle.
How to attach TUBE 465
1 ► Insert TUBE 465 into the P nozzle. Make sure that there is a nozzle seal between TUBE
465 and the P nozzle. Note that the torque of screwing the nipple should be 0.25 Nm.
2 ► Set the tube holder into both the P arm internal cover and the P arm cover, and attach
the P arm cover.
3 ► Arrange TUBE 465 as shown in Figure 4.4-24, and insert into tube joint 2 (refer to
Figure 4.4-25). Note that the torque of screwing the nipple should be 0.25 Nm.
4 ► Attach screw A of the PR cover.
5 ► Make sure that the tube moves smoothly when the P arm is moved vertically.
TUBE 510
How to remove TUBE 510
1 ► Remove the tube guide assembly (refer to Figure 4.4-19).

2 ► Remove two (2) screws A from the PR cover (refer to Figure 4.4-20).
3 ► Move the P Carrier to the left end, and cut the two (2) tie wraps that fix TUBE 510.
4 ► Remove TUBE 510 from the tube joint (refer to Figure 4.4-21 and Figure 4.4-22).
5 ► Remove TUBE 510 from tube joint 2 (refer to Figure 4.4-23).
How to attach TUBE 510
1 ► Insert TUBE 510 into both tube joint and tube joint 2. Note that the torque of screwing
the nipple should be 0.25Nm.
2 ► Fix TUBE 510 with two (2) tie wraps (Refer to Figure 4.4-21, Figure 4.4-22 and Figure
4.4-23). Ensure that the direction of the nail of the tie wrap is the same as in the figures.
Be careful not to twist the tube.
3 ► Attach the tube guide assembly. Be careful not to nip the GNP line.
4 ► Attach screw A of the PR cover.

Figure 4.4-19 Pipetter Unit
Figure 4.4-20 Pipetter Unit
1 PR cover
2 M4 screws
3 Tube Joint
4 Pressure Sensor

Figure 4.4-21 Back
1 Guide (P/N: 741-0895)

2 PR cover
3 Tube 510
4 Tube Joint
Figure 4.4-22 Tube510
1 Wrap tie
2 Tube510
3 Nipple
4 Inner Tube
5 Outer Tube

Figure 4.4-23 Tube Joint
1 Railbase
2 Tube Joint 2
3 Tube 465
4 Ty-rap
5 Tube 510
6 Nipple
Figure 4.4-24 TUBE 465

1 P Arm Cover
2 P Arm Inside Cover
3 Tube holder
4 Nozzle seal
5 P Nozzle
6 Nipple
7 Tube 465
Figure 4.4-25 P Carrier left side
1 Tube Joint 2
2 Tube 465
3 P Arm Cover
4.4.6 Gripper Mechanism
4.4.6.1 Overview
The gripper mechanism consists of the following 3 components and transfers tips/vessels
between the container station, buffer station, and incubator.
1. Gripper --- transfers tips/vessels via X/Y/Z grip mechanism.

2. Container station --- can hold 3 tip containers and 3 vessel containers.
3. Incubation station --- There are 32 incubator stations and one sipping station on the heat
block.
4.4.6.2 Location
See Chapter 4.2.
4.4.6.3 Detailed Function
This unit consists of the following components:
• Base frame
• Y carriage
• X carriage
• Grip part
• Container station
• Incubator station
Base Frame
Base frame is fixed on the four (4) pillars that are secured to the main base. The carrier
mechanisms such as the Y carriage, container station, and incubator station, are attached to the
base frame.
Y Carriage
The Y carriage contains the X carriage (mentioned below). It is driven in the Y direction (back and
forth movement) and placed (at 0.25 mm/step) via the stepping motor and the pulley belt
mechanism. The Y carriage is supported by the following bearings:
• On the right side: Two (2) linear bearings that are guided by a shaft
• On the left side: One (1) radial bearing that is guided by the channel
A shielding plate on the right of the Y carriage passes via three (3) photo interrupters fixed on the
base frame and detects home position, rest position, and end position (the order starts from the
front).
X Carriage
The X carriage contains the grip parts described below. It is driven in the X direction (left and right
movement) and placed (at 0.125 mm/step) via the stepping motor and the pulley belt mechanism.
A shielding plate on right of the X carriage passes via 3 photo interrupters on the right side of the
Y Carriage and detects home position.
Grip Part
The grip part consists of the Z-driving part and the grip-driving part. The grip-driving part consists
of a rack gear driven in the Z direction (up and down shift) and placed (at 0.2 mm/step) via the
stepping motor and the Z-drive part of the rack/pinion mechanism. The grip-drive part is

supported by a linear guide fixed to the X carriage and is pulled up via a spring. A shielding plate
secured on the upper side of the grip-drive part passes via 3 photo interrupters at the upper side
of the X carriage and detects home position.
The grip-drive part is driven to open/close via a cam rotated by a rotary solenoid and a pair of
arms with a grip nail positioned to catch the cam. The tip/vessel is gripped at the nail by the
power of pull-spring attached to close a pair of arms and is positioned on X & Y where the back
arm is pushed by the cam. A shielding plate located at the tip of the front arm passes via Photo
Interrupter under the condition w/o tip/vessel and detects “None.” Also, a pair of arms are
supported and guided to up and down shift as well as holder which retains the arms above and
below and positioned to the lower edge by two (2) push-springs. If Grip-drive part is lowered to
abnormal positions on XY, the head part of tip/vessel halts the down movement of a grip nail,
arms, and a holder. A shielding plate located at the bottom side of Grip-drive part passes via
Photo Interrupter secured to the holder and detects “Abnormal Down Position.”
Container Station
The container station has a partition to hold three (3) tip containers and three (3) vessel
containers and is positioned at the base frame via two (2) pins located at the bottom side and
secured by four (4) screws.
Incubator Station
Incubator Station consists of the heat block with thirty-two (32) storage holes for vessel incubation
with one (1) vessel storage hole sipping, heater, and thermistor. It is secured to the base frame
by two (2) screws.

4.4.6.4 Explanatory Figures
Figure 4.4-26

Figure 4.4-27

Figure 4.4-28

4.4.6.5 Parts List
Table 4.4-3
Part name
Position No. Short Name Material number Part number
Comment
1 T/V CARRIER 741-0409
ASSY
2 PM062 Motor Y assy 741-4319
Motor Y assy;
motor & cable &
pully & dumper
3 PI063 CORD P563 Y- 741-4306
HP; PI 063
4 PI064 PI065 CORD P5634 Y- 741-4307
EP-RP; PI
064/65
5 Circuit Board 741-5047
Assy DIST-TVA
6 PM061 Motor C Assy 741-4320
with PULSE K591137
MOTOR
KH42JM2-011
Motor C assy,
motor x-move
7 Motor Cover X 741-8530
8 Holder C 741-1139
9 PM063 Pulse Motor 741-4321
PF25-48D4 Assy
Gripper-Z; UP
DOWN PF25;
motor
10 Cover Z 741-8534
11 Carrier Z assy / 741-0412 / 741-
Plate 8533
12 SOL Rotary solenoid 741-4322
2ER45-33 assy
13 FPC-C1 Cord FPC C1 741-4323

Part name
Comment
From Dist-TVA to
Gripper-Z
14 FPC-C2 Cord FPC C2 741-4324
From Dist-TVA to
carrier x-motor
15 FPC-C11 Cord FPC C11 741-4325
Gripper-Z;
open/close
PI068; Abn.
PI067
16 FPC-C21 Cord FPC C21 741-4326
Gripper-Z; UP
DOWN PF25;
PI066
17 Thermostat INC 741-0761
Assy
18 Thermistor I 741-0582
19 Timing Belt C(X) 741-1143
Gripper X-belt
20 Timing Belt C(Y) 741-1124
Gripper Y-belt
Sensor
TLP830 PCB ASSY J339168
DETECT 3
TLP830
Signal photo
coupler used in
Gripper assy;
see list of
Sensors SM
chapter 4.3.2
Tool gripper 741-1471
adjustment
Gripper sensor 741-2022
tool

Part name
Comment
Tool transport 741-2154
module
adjustment
For automatic
adjust
Note: Do not damage the FPC cable, handle with care.
Note: When removing the FPC cable from the connector, move the slide lock of the connector
towards the cable and take out the cable.
Note: When mounting the FPC cable, mount it in the right direction and lock it.
Note: When peeling double-sided tape from the FPC cable, hold the cable so that no extra tension
is placed on the corner and peel slowly.
Removing the Units
Remove the following covers:
• Rear cover
• Gripper Y cover
• Front cover
• Table cover R
• Sipper front cover
• S guide plate/board cover (at the right side of solid waste)
• Unscrew four (4) screws and four (4) connectors to remove the unit from the main base pillars.
• Assemble the units by re-installing the units removed during the disassembly procedure (see
above) in the reverse order.
• However, position-teaching adjustment is required after assembly. See Adjustment Operation.
Disassembly and Assembly of the Units
1. Y motor assembly
2. P563, P564 cord assembly (Y-axis photo interrupter board)
3. DIST-TV board assembly
4. X motor assembly
5. Z motor assembly
6. Solenoid assembly

7. FPC cable C1, C2, C11, C21 assemblies (including X axis, Z axis, and photo interrupter at
grip).
8. X carriage assembly
9. Heater I assembly (including thermostat).
10. Thermistor I assembly
Y Motor Assembly
1 ► Remove the Y motor.

1.1 ► Unscrew two (2) screws.
2 ► Pull out cords.
2.1 ► Remove two (2) clamps, FPC holder, FPC connector, DIST-TV board connector.
Assembly:
1 ► Assemble the motor by re-installing the parts removed during the disassembly
2 ► Fix the belt at the position where the tension of the belt satisfies the conditions shown in
the following figure.
3 ► The cable should be straight.
Figure 4.4-29
P563, P564 Cord Assembly (Photo Interrupter Board for Y Axis)
Disassembly
1 ► Remove DET-A (Y-HP), DET-B (Y-RP/EP) board.

1.1 ► Unscrew two (2) screws from each.
2 ► Pull out the cord.
2.1 ► Release four (4) tie wraps, three (3) clamps.
2.2 ► Unscrew the DIST-TV board connector.
Assembly
► Assemble the cord assembly by re-installing the parts removed during the disassembly
DIST-TVA Board Assembly
Disassembly
1 ► Remove the DIST-TVA board assembly

1.1 ► Unscrew two (2) screws and five (5) connectors.
Assembly
1 ► Assemble the DIST-TVA board assembly by re-installing the parts removed during the
disassembly procedure (see above) in the reverse order.
X Motor Assembly
Disassembly
1 ► Take out the X motor cover.

2 ► Remove the X motor holder.
Assembly
1 ► Assemble the X motor assembly by re-installing the parts removed during the
2 ► Fix the belt at the position where the belt tension satisfies the following conditions.
Figure 4.4-30
Z Motor Assembly
Disassembly
1 ► Take out the Z cover.

2 ► Take out blind plate.
3 ► Remove the Z motor assembly.
3.1 ► Unscrew two (2) screws and a connector.
Assembly
1 ► Assemble the Z motor assembly by re-installing the parts removed during the
2 ► Fix the Z motor and the opponent rack where backlash of the rack gear and pinion of
the motor is 0.1 ~ 0.2 mm.
3 ► Hold the pinion with fingers, and confirm the backlash.

Solenoid Assembly
Disassembly
1 ► Take out the Z cover .

2 ► Remove lead wire from the solenoid.
2.1 ► Release two (2) tie wraps and two (2) ‘1P’ connectors.
3 ► Remove grip/trouble detect board of FPC cable C11 assembly.
4 ► Dismount grip-drive assembly.
4.2 ► Unhook lower hook of spring.
5 ► Rotate half and remove solenoid assembly.
5.1 ► Unscrew two (2) nuts.
Assembly
1 ► Assemble the solenoid assembly by re-installing the parts removed during the
2 ► Fix grip/trouble detect board at the position where the shielding plate is centered in
photo interrupter.
FPC cable C1, C2, C11, C21 assemblies (including X axis, Z axis, and photo interrupter at grip.
(See Handling Note for FPC Cable)
Disassembly
1 ► Take out the X motor cover.

2 ► Take out the X Cover
3 ► Take out the Z Cover
4 ► Remove the cable (Y driving part) between the Y carriage and the DIST-TV board.
4.1 ► Remove two (2) FPC holders, two (2) board connectors, and tape-glued part.
5 ► Dismount the X motor connector board
5.1 ► Unscrew two (2) screws and a connector.
5.2 ► Release tie wrap.
5.3 ► Remove a board connector and tape-glued part.
6 ► Remove the X motor holder.
6.2 ► the See section on X motor assembly.
7 ► Remove FPC holders located at the upper right side of Y carriage.
7.1 ► Unscrew four (4) screws.

8 ► Dismount the relay connector board.
8.1 ► Unscrew each screw and a connector.
8.2 ► Then remove FPC cable C1, C2 assembly.
9 ► Remove the cable (X-driving part) between relay connector and X carriage.
9.1 ► Release 2 saucer screws and FPC holder fixtures,.
9.2 ► Pull out the cable.
10 ► Take out the FPC holder at the upper part of the Z motor.
10.1 ► Unscrew one (1) screw.
11 ► Dismount the Z motor connector board.
12 ► Remove the Z-HP photo interrupter board.
12.1 ► Unscrew one (1) screw.
13 ► Take out the grip/trouble detect board.
13.2 ► Release tie wrap and connector.
13.3 ► See the section on solenoid assembly.
Assembly
► Assemble the FPC Cable C1, C2, C11, C21 Assemblies by re-installing the parts
removed during the disassembly procedure (see above) in the reverse order.
X Carriage Assembly
Disassembly
1 ► Take out the X cover.

2 ► Release FPC cable C11, C21 assemblies from relay connector and FPC holder
2.1 ► Unscrew two (2) saucer screws.
2.2 ► Pull out the cable.
3 ► Remove X carriage assembly.
3.1 ► Unscrew two (2) back-lower screws.
3.2 ► Release gear of the belt.
Assembly
1 ► Assemble the X carriage assembly by re-installing the parts removed during the
2 ► Fix the X carriage assembly on the tip container in the position where the left surface of
the X carriage assembly and the top side of the tip container satisfy the perpendicular
angle 0.2 mm/100mm.

Heater I Assembly (including thermostat)
Disassembly
1 ► Dismount the incubator station from the base frame.

2 ► Remove the J570 connector.
2.1 ► Take out tie wrap and clamps.
3 ► Remove heater and thermostat.
3.1 ► Unscrew two (2) screws from each.
Assembly
1 ► Assemble the heater I assembly by re-installing the parts removed during the
2 ► Apply sufficient Amicon epoxy resin to the heater part.
Thermistor I Assembly
Disassembly
1 ► Dismount the incubator station from the base frame.

2 ► Take out the J571 connector.
2.1 ► Remove tie wrap and clamps.
3 ► Remove the heat block from the base.
3.1 ► Unscrew three (3) bottom screws.
4 ► Peel off insulation packing.
5 ► Peel off aluminum tape.
6 ► Remove the thermistor I assembly.
Assembly
1 ► Assemble the thermistor I assembly by re-installing the parts removed during the
2 ► Apply sufficient Amicon epoxy resin to the heater part.

Detail of incubator
Figure 4.4-31
1 Heater
2 Thermistor
3 Incubator Thermostat
4.4.7 Sipper Mechanism
4.4.7.1 Overview
The sipper transports the probe that is connected to the syringe with tubes from one station to
another via the measuring cell.
4.4.7.2 Location
See Chapter 4.2.

The sipper unit consists of the following:
• Base Frame
• X Carriage
• Z Carriage

Base Frame
The base frame is fixed on the platform that is secured on the top part of the main unit base. The
X carriage and Z carriage are installed on the base frame.
X Carriage
The X carriage contains the Z carriage, which is explained below. The X carriage shifts
horizontally at a speed of 0.3 mm/step to its position, and is driven by the stepping motor and
pulley / belt mechanism. At its top, the X carriage is held up by two linear bearings that are
supported by the shaft, and at the bottom the X carriage is supported by two radial bearings.
There are two photo interrupters on the base frame. The home position sensor is on the right and
the end position sensor is on the left (as viewed from the front of the cobas e411). The X carriage
stops in six positions: CC2, AB2, CC1, AB1, Washing Pos., and Sipping Pos. in a normal
operation.
Z Carriage
The Z carriage shifts vertically at a speed of 0.1 mm/step (during the aspiration of the reaction
agent at 0.025 mm/step) to its position, and is driven by the stepping motor and the pulley / belt
mechanism. The Z carriage is supported by the linear guide that is installed on the X carriage.
The shielding plate that is installed on the right side of the Z carriage passes the photo interrupter
above the top of the X carriage and detects the home position. The probe inside the Z carriage is
moved vertically and is positioned to the bottom end by a spring. If the Z carriage descends from
an abnormal position, the mechanism interrupts the descent of the probe and the shielding plate
interrupts the beam from the photo interrupter that is installed on the Z carriage. This leads to an
error, “Abnormal Descending.”

4.4.7.4 Detailed Diagrams
Figure 4.4-32

Figure 4.4-33

Figure 4.4-34
4.4.7.5 Parts List
Table 4.4-4

1 Sipper Z Assy 741-0416
2 X Motor Assey 741-4248*
4 Front Cover 741-8547
5 Suppot S 741-8182


6 Cover S 741-8181
7 Cord P587 Assy With Motor 741-4251*
8 Cover R 741-8542
9 Cover L 741-8543
10 Bracket 741-1474
11 S Nozzle Box Assy 741-0933
12 Cover 741-8541
13 Circuit Board Assy DIST-SA 741-5046
14 Cord FPC S 741-4253
15 Fixing Plate 741-1481
16 Base 741-8540
17 SS COVER ASSY 741-0350
∗ Refer to Motor Reference List, Chapter 4.3.1
Removing the Sipper Unit
First remove the following covers:
• Rear cover
• Gripper Y cover
• Front cover
Then remove the following parts from the sipper unit and take out the sipper from the main unit
platform:
• Four screws
• One tube
• Three connectors
• One grounding wire
To reassemble the sipper unit, you can re-install the parts removed in the above procedure in the
reverse order. Be sure to position the unit so that the tip of the probe passes the center of the
sipper position vessel and the reagent container cap. Also, adjust its position by tapping,
following the procedure in the adjustment procedure that is described separately.
Disassembly and Assembly Procedures
• X Motor Assembly & Photo Interrupter

• Z Motor Assembly & Photo Interrupter
• Probe Assembly
• DIST-S PCB Assembly
• FPC Cable S Assembly
1. X Motor Assembly and Photo Interrupter
Disassembly
1 ► Remove the front cover by unscrewing three (3) screws.

2 ► Remove the FPC holder by unscrewing three (3) screws.
3 ► Remove the top cover by unscrewing one (1) screw.
4 ► Remove the X motor assembly by removing two (2) screws and connector P585.
5 ► Remove the photo interrupter by removing the connector and pushing the hook on its
back.
Assembly
Re-install all the parts removed in the disassembly procedure in the reverse order. When
installing the X motor assembly, secure the part at the position where the belt tension satisfies the
specifications below.
Figure 4.4-35
2. Z Motor Assembly and Photo Interrupter
Disassembly
1 ► Remove X carriage covers (R), (L) by unscrewing two (2) screws each.
2 ► Remove the Z motor assembly by removing two (2) screws, motor connector, and tie-
wraps.
3 ► Remove the photo interrupter holder by removing two (2) screws.
4 ► Remove the photo interrupter by removing the connector and pushing the hook on its
back.
Assembly
Re-install all the parts removed in the disassembly procedure in the reverse order. When re-
installing the Z motor assembly, be sure that the belt tension meets the specifications described
in the figure above.

3. Probe Assembly
Disassembly
1 ► Remove the Z carriage cover by pushing the hook on the bottom.

2 ► Take out the probe assembly by removing the 1P connector.
Assembly
Re-install the parts removed in the disassembly procedure in the reverse order.
4. DIST-S Board Assembly
Disassembly
Remove the DIST-S PCB assembly by unscrewing by two (2) screws and four (4) connectors and
then release the sliding lock of the connector to the cable side, and taking out the DIST-S board.
Assembly
Re-install all the parts removed in the disassembly procedure in the reverse order.
5. FPC Cable 3 Assembly
CAUTION
Be careful not to damage the cable.
Disassembly
1 ► Remove the FPC holder by unscrewing three (3) screws.

2 ► Remove the top cover by unscrewing three (3) screws.
3 ► Release the sliding lock and disconnect the cable from the DIST-S board connector.
4 ► Remove the connector which side of Z motor cord.
5 ► Remove the holder from the relay board by unscrewing two (2) screws.
6 ► Remove the double-sided tape and the cable from the left side of the holder.
7 ► Remove the FPC holder of the Z carriage (by unscrewing one (1) screw) and take out
the Z carriage.
8 ► Slide out the failure-detection photo interrupter board.
9 ► Remove the 1P connector from the Z carriage base by pushing it up from the bottom
with tweezers.
Assembly
Re-install all the parts removed in the disassembly procedure in the reverse order. Make sure that
none of the cables are entangled.

4.4.8 System Reagent Mechanism
4.4.8.1 Overview
The system reagent mechanism is a unit that keeps the liquid temperature constant inside the AB
and CC bottles. The case of the system reagent mechanism has grooves for an AB bottle and a
CC bottle. By setting an AB bottle and a CC bottle, one at a time, it adjusts the case temperature
by means of a Peltier temperature controller.
4.4.8.2 Location
See Chapter 4.2.
The System Reagent Mechanism consists of the following components:
• Bottle Heating Unit

• Case Heating Unit
• Thermostat
Bottle Heating Unit
The bottle heating unit is a die-cast product made of flat aluminum (5mm thick). Its function is to
keep the liquid temperature inside the AB and CC bottles at 28 C. This aluminum case detects
the signals from the sipper probe when the sipper probe detects the liquid level in the bottle, and
is therefore insulated from other parts and the main unit base.
Case Heating Unit
Insulating material is attached to the bottom and sides of the aluminum case and, in addition, the
case is enclosed in a steel case frame so that the bottles inside the case are not be subject to the
ambient temperature. In order to secure the thermostat, the case frame is installed on the main
unit base and is fixed to the cooling unit holder. The case frame is also used as a holder for the
sipper probe wash bath.
Thermostat
A Peltier element thermostat is installed on the outside bottom of the aluminum case. A thermistor
is installed in the space between the case surface and the side of the case. It measures the
difference between the ambient temperature and the case temperature, and the thermostat
regulates the case temperature.

4.4.8.4 Detailed Diagram
Figure 4.4-36
4.4.8.5 Parts List
Table 4.4-5

1 Case 741-1379
2 Holder R 741-8659
3 Case S 741-8153
4 Cover 741-1387


5 Bush A 741-1382
6 Bush B 741-1383
7 Micro-Cooler SR Assy 741-0756
8 Thermistor Assy 741-0548
9 Wave Washer WW-5 M874001
10 Sensor SR Assy 741-0663
Removing the System Reagent Unit
To remove the system reagent unit, first remove the following covers:
• Rear Cover
• Gripper Y Cover
• Front Cover
• SR Cover
Then, remove two (2) screws and three (3) connectors (P660, P661, and P662). Also, pull out the
fixtures of the cooling unit holder from the case table installed on the main unit base.
Disassembly and Assembly of the System Reagent Unit
1 ► Remove the steel plate around the case cover assembly and case frame assembly.
1.1 ► Remove the sockets from connectors J660, J661, and J662.
1.2 ► Remove the four (4) screws from each.
2 ► Turn the unit upside down.
3 ► Remove the thermostat.
3.1 ► Remove the four (4) screws.
4 ► Remove the cooling unit holder.
Assembly Procedure
Assemble the system reagent unit by re-installing parts removed during the disassembly
procedure (see above) in the reverse order. When installing the thermostat, apply heat-
conducting grease to the surface that is contact with the aluminum case. Since the unit is
installed through the cooling unit holder, install bush A, bush B, and washer in this order as
shown in the figure below:

Figure 4.4-37
4.4.9 Syringe Mechanism
4.4.9.1 Overview
The syringes consist of the two systems described below. The syringes transport liquid, driven by
the pumping force generated by the up and down movement of the plunger and by the movement
of the probe of each system.
1. Pipetter Syringe (Left): Aspirates and pipettes specified amounts of the sample, reagent, and
beads via the pipetter probe and tube.
2. Sipper Syringe (Right): Aspirates specified amounts of the reaction mixture via the sipper
probe, tube, and measuring cell.
4.4.9.2 Location
See Chapter 4.2.
Each syringe consists of the following components:
• Base Frame
• Syringe Motor
• Flow Route Switch
Base Frame
The base frame is fixed to the main unit base. The syringe motor and the flow route switch are
installed on the base frame.
Syringe Motor
In the syringe motor, the slider that moves the syringe plunger moves in the vertical direction is
driven by the stepping motor and pulley / belt mechanism to a specified position. The slider is
supported by two linear bearings that are guided by the shaft. A shielding plate is installed on the
back of the slider, and when the slit passes by the photo interrupter that is located above it the
home position is detected. On the slider is the plunger assembly, which is supported by the
sealing inside the sealing body, the O ring, and the syringe, mounted in this order. These parts

are secured at the top with a nut and connected with each other by tubing. The plunger assembly,
O ring, and syringe are different in the two syringe systems. The parts for the sipper syringe (on
the right side) have larger diameters.
Flow Route Switch
The sipper syringe system is connected with pinch valves SV3 (at the measuring cell) and SV4
(at the liquid waste container) by tubing.
Figure 4.4-38

4.4.9.5 Parts List
The parts for the pipetter syringe system are installed on the left side of the unit, those for the
sipper syringe system on the right side.
Table 4.4-6

1 Base N 741-8037
2 Syringe PS Assy 741-0418
3 Pulse Motor PH265M33 Assy 741-0804
(Pip, PH265M-33-C3)
4 Motor S Assy (Sip, KH56KM2- 741-0806*
016)
5 Detect 3 PCB 130T Assy 741-0810
6 Syringe P Assy (Pip) 741-0801
7 Syringe S Assy (Sip) 741-0802
8 Syringe (Pip) G825045
9 Syringe S (Sip) 741-1313
10 Pinch Valve 2 Assy 741-0833
∗ Refer to Motor Reference List, Chapter 4.3.1.
CAUTION
Before removing the flow route tubing, prepare a
beaker, a syringe, and a cloth wiper. Drain water from
the tubing, and wipe up any spillage.
Removing the Syringes
• Rear cover
• Gripper Y cover
• Front cover
• Sipper FPC holder (secured with 3 screws)
• Sipper top cover (secured with 1 screw)
• Sipper bottom cover (secured with 2 screws)
Then, remove the three (3) screws, four (4) tubes (two small tubes, one small black tube, and one
big tube), five (5) connectors (P622, P591, P592, P593, J630), and finally remove the syringes
from the main unit base.

Disassembly and Assembly of Syringes
• Syringe Motor Assembly, Motor Assembly, Photo Interrupter Assembly

• Syringe Plunger Assembly
• Pinch Valve Assembly
Syringe Motor Assembly, Motor Assembly, and Photo Interrupter Assembly
1 ► Remove the syringe motor assembly by unscrewing the upper and lower screws and
removing the tube and lead wire from the clamp.
2 ► Remove the motor assembly by unscrewing two (2) screws, removing the lead wire
from the clamp, and removing the connector and contact.
3 ► Remove the photo interrupter assembly by unscrewing one (1) screw, removing the
lead wire from the clamp, and removing the connector and contact.
Assembly Procedure
Reassemble the unit by following the disassembly procedure in the reverse order.
Note: If you have loosened the belt, readjust the belt tension by (1) loosening the tension bolt, (2)
adjusting the tension axle phase, and (3) securing the tension bolt again. (See the figure
below.)
Figure 4.4-39
1 Timing Belt
2 Tension Belt
3 Tension Axle
4 Tension Gauge (a tension of 1.67N)
5 Red mark
Adjusting the Timing Belt Tension

As shown in the above figure, press the gauge against the belt, adjust the tension axle until the
gauge shaft is aligned with the red marking, and tighten the tension bolt to secure the belt.

Syringe Plunger Assembly
1 ► Remove the two (2) tubes, one upper and one lower.
2 ► Loosen the clamp nut on the top of the unit.
3 ► Remove the syringe plunger assembly.
Assembly Procedure
Reassemble the unit by re-installing the parts removed in the disassembly procedure in the
reverse order.
Pinch Valve Assembly
► Remove pinch valves SV3 and SV4 by removing two (2) screws, a tube, a connector,
and a contact.
Assembly Procedure
► Reassemble the unit by re-installing the parts removed in the disassembly procedure in
the reverse order.
4.4.10 System Water Container (Float SW) Mechanism / Pump Assembly
4.4.10.1 Overview
The system water container contains system water for each wash bath and syringe. It consists of
the following two parts.
1. System Water Container (capacity: 3 liters)

2. Buffer Tank (capacity: 200 mL, with float SW)
4.4.10.2 Location
See Chapter 4.2.
The system water container consists of the following components:
• System Water Container

• Buffer Tank
System Water Container
The system water container has a handle and a cap on its upper part and a plug in its bottom part.
It is filled with system water and is connected to the piping when positioned as specified.

Buffer Tank
The buffer tank is installed on the main unit base. It has a guide for container installation and a
plug that faces the plug of the system water container. It also has a float SW and a degassing
tube in its inside upper corner. A tube for connection to the pump and a tube for connection to the
valve are connected on the back of the tank.
Figure 4.4-40
4.4.10.5 Parts List
Table 4.4-7

1 Water Reservoir Assy 741-0302
2 Buffer Tank Assy 741-0561
3 Cap D Assy 741-0560
4 Buffer Tank Cover 741-1502
5 Float Switch Assy 741-0563
6 Filter Cup 741-1505
7 Filter L472061

CAUTION
Before removing the flow route tubing, prepare a
beaker, a syringe, and a wiper. Drain water from the
tubing, and wipe up any spillage.
Removing the System Water Container Unit
• Rear cover
• Gripper Y cover
• Front cover
Then remove the three (3) screws, three (3) tubes. Finally, remove the system water container
unit from the main unit base.
Disassembly and Assembly of the Unit
• Ball sealing assembly of system water container

• Buffer tank assembly, ball sealing assembly, and float SW
Ball sealing assembly of system water container
► Remove the ball sealing assembly that is secured with a closed nut. When you remove
the inner closed nut, you will find a filter, a spring, ball, and an O ring installed over the
nut and packing outside the nut.
Assembly Procedure
► Reassemble the unit by re-installing the parts removed in the disassembly procedure
Buffer tank assembly, ball sealing assembly, float SW
1 ► Remove the tank lid by unscrewing the seven (7) screws. When you turn the tank
upside down and remove the closed nut of the ball sealing assembly, you will find a filter,
a spring, ball, and an O ring installed over the nut.
2 ► Remove the float SW that is secured with a nut.
Assembly Procedure
4.4.10.7 Pump Assembly
Overview
The pump assembly supplies system water from the system water container to the wash baths
and syringes via the valve block.
Functional Details
The pump assembly consists of the following components.
• Drain pipe
• DC magnet pump
• Valve block
For further details, refer to Chapter 3, Fluidics.
Detailed Diagram / Parts List
741-2171 Filter ( Water pump )

Figure 4.4-41

Figure 4.4-42
4.4.10.8 Parts List
Table 4.4-8

1 CHOKE PIECE S10 714-1257
2 SOLENOID VALVE UDV ASSY 741-0830
3 DC MAGNET PUMP ASSY 741-0832
4 JOINT 741-1602
5 PIPING BLOCK 741-1603
6 NIPPLE 741-1606
7 PIPE M2 741-2190
8 BASE R 741-8654
9 SUPPORT R 741-8661
10 PLATE R 741-8669
11 TYGON TUBE R3603 3.17IDX6.35OD G153001
12 SILASTIC TUBE 8IDX14OD G153171
13 SOCKET CONTACT DF1BA-4DEP-2.5RC J830575
14 PLUG DF1BA-10DEP-2.5RC J830577
17 ELBOW JOINT 198-19-23-05E L369125
18 O-RING NBR P4 L456001
19 O-RING NBR P5 L456002
20 MARK BAND KL-1 5 L991365


21 MARK BAND KL-1 6 L991366
4.4.11 Liquid Waste Container Mechanism
4.4.11.1 Overview
The liquid waste container consists of the following two units. It collects wash liquid and reaction
waste.
1. Liquid waste container (capacity: 4 liters)

2. Container station (capacity: 3.5 liters, with fill level detector; also detects whether or not the
container is installed.)
4.4.11.2 Location
See Chapter 4.2.
The liquid waste container consists of the following components:
• Liquid waste container

Liquid Waste Container
The liquid waste container has a handle and a cap on its upper part. Remove the cap and
position the liquid waste container in the specified position.
Container Station
The container is located in the inner station of the container station. The inner station is attached
to the outer station that is installed in the main unit base and is pushed up by a shaft on the back
and by a spring in the front. A shielding plate is installed in the inner station. This shielding plate
is depressed as the waste liquid level increases. When it is depressed, it passes the beam from
the photo interrupter installed in the outer station and thus indicates when the waste liquid
container is full. A pressure plate with a shaft and coil spring is attached to the front of the inner
station. This pressure plate is installed so that it pushes in the container. A shielding plate is
installed on one end of the pressure plate. If a container is not installed, the pressure plate will
cause the photo interrupter beam to come through the shielding plate and the “no container” state
is detected.

Figure 4.4-43
4.4.11.5 Parts List
Table 4.4-9

1 Liquid Waste Tank 741-1510
2 Liquid Waste Base Assy 741-0438
3 Cord J631 741-4310
5 Bottle Sensor Assy 741-0566


6 Support 741-1513
7 Shaft L2 741-1526
8 Spring L 741-1523
9 Waterproof Cover S1 741-8180
Removing the Liquid Waste Container Unit
• Rear cover
• Gripper Y cover
• Front cover
Then remove the three (3) screws, and then the liquid waste container unit from the main unit
base.
• Photo Interrupter
• Inner Station and Pressure Plate Assembly
Photo Interrupter
1 ► Remove the cord assembly (J631).

2 ► Remove the photo interrupter (P1132: container detector; P1133: fill level detector)
Assembly Procedure
Inner Station and Pressure Plate Assembly
1 ► Remove the pressure plate assembly by unscrewing two (2) screws.

2 ► Remove the inner station, a shaft, and a spring. Remove the E ring to remove the shaft.
Assembly Procedure

4.4.11.7 Adjustment Procedure regarding Liquid Waste Full after few cycles
during installation
Check that Waste Full Error takes place correctly as follows;
Check Procedure
1 ► Make sure that the instrument is in Stand-by status by checking that Stand-by appears
on the screen.
2 ► Fill with distilled water ta depth of 115 mm from the bottom of waste tank (equal to 3.4
liters).
3 ► Make sure that a Waste Full Error is not shown in Reset status. If a Waste Full Error is
shown, adjust according to the adjustment procedure.
4 ► Add a further 200 ml of distilled water to the tank.
Make sure that a Waste Full Error is shown in Reset status. If a Waste Full Error is shown, the
setting is OK. If not, adjust according to the adjustment procedure.
Adjustment Procedure
1 ► Remove the rear cover and front cover.

2 ► Switch on the instrument.
3 ► Make sure that the instrument is in Stand-by status by checking that Stand-by appears
on the screen.
4 ► Fill with distilled water to a depth of 120mm from the bottom of the waste tank (equal to
3.5 liters).
5 ► Unfasten the hex nut shown in Figure 4.4-44.
Figure 4.4-44 Side view of liquid waste container
6 ► Find a border point where the voltage changes between high (ca. 5V) and low (ca. 0V)
by turning the minus screw located at the top of support S (P/N741-8621) with a minus
screwdriver. Measure the voltage between Pin #5 and Pin #6 on connector J631.
7 ► Fasten the hex nut at the border point.
8 ► Check the function again according to the check procedure.

4.4.12 Solid Waste Mechanism
4.4.12.1 Overview
The solid waste mechanism is designed to efficiently collect tips and vessels used by the
analyzer. It levels the used tips and vessels collected by vibrating the waste box periodically.
4.4.12.2 Location
See Chapter 4.2.
The mechanism of this unit is shown below.
Mechanism of Solid Waste
The solid waste mechanism generates vibration towards the long dimension of the waste box set
in the unit. The crank mechanism consists of the assembly, lever and roller bearing that are fixed
to the stepping motor and motor shaft as well as the drive tray that holds a tray to settle waste in
the box. The solid waste mechanism generates straight-line forward & reverse movement
referenced to the long dimension.
Step angle 1.8°/step
Stroke 30 mm

Figure 4.4-45
4.4.12.5 Parts List
Table 4.4-10
Pos.
Part Name Part No.
No.
1 Motor S Assy 741-0581*
2 Cord J641 741-4311
3 SW Retainer 741-1369
5 Clamp CKS-05-L J839400
6 Clamp CKS-10-L J839402
7 Wire Binder TY-23M J839050
8 Fixture 741-1361
9 Tray 741-0534
∗ Refer to Motor Reference List, Chapter 4.3.1.
4.4.12.6 Procedures for Disassembly/Assembly
Removal of the unit
1 ► Confirm that the disposable tray assembly (waste box) is not left in the equipment.
Remove if still present.
2 ► Remove the gripper of each cover (see 4.4.8.6).

3 ► Remove FDD base S, FDD base L, MC latch, FDD guard, and floppy disk.
4 ► Unscrew four (4) screws and two (2) connectors. Then remove the unit from the main
base.
To assembly the unit re-install the parts removed during the removal procedure (see above) in
the reverse order (4~1). Position adjustment is not required.
Disassembly/Assembly of the Unit
• Motor S assembly
• J641 cord assembly
• Photo Interrupter GP1A34LC
Motor S Assembly
Disassembly
1 ► Remove the motor.

2 ► Remove the motor S assembly.
2.1 ► Release clamps in two (2) places.
Assembly
► Assemble the motor S assembly by re-installing the parts removed during the
J641 Cord Assembly
Disassembly
1 ► Remove the sensor holder from SW base.

2 ► Remove the J641 cord assembly.
2.1 ► Replace tie wraps in three (3) places, clamps in four (4) places
2.2 ► Unscrew two (2) screws for sensor holder.
2.3 ► Remove photointerrupter GP1A34LC connector.
Assembly
► Assemble the J641 cord assembly by re-installing the parts removed during the
Photo Interrupter GP1A34LC
Disassembly
1 ► Replace photo interrupter GPA.

1.1 ► Release connector.
Assembly
► Assemble photo interrupter GP1A43LC by re-installing the parts removed during the
Disassembly 2 (without removing unit)
1 ► Confirm that the disposal tray assembly (waste box) is not left in the equipment.
Remove if still present.
2 ► Dismount the container station of the gripper unit.
3 ► Move drive-tray forwards manually.
4 ► Remove photo interrupter GP1A34LC.
4.1 ► Remove the connector of the J641 cord assembly.
Assembly 2
► Assemble photo interrupter GP1A34LC by re-installing the parts removed during the
4.4.13 Detection Unit
4.4.13.1 Overview
The detection unit of cobas e411 has the following major components.
1. Photomultiplier and its housing

2. Circuit boards for PMT and amplifier
3. Peltier heat exchanger
4. Magnet driver
5. Measuring cell
6. Heat insulating casing
4.4.13.2 Location
See Chapter 4.2.
The figures below show the principal components and the parts in the detection unit as each
number.
Table 4.4-11 Components
Pos. No. Component

1 PMT assembly
2 PMT HV circuit assembly
3 Peltier heat exchanger
4 Magnet driver

Pos. No. Component

5 Amplifier assembly for PMT signals
6 Measuring cell
Table 4.4-12 Parts

7 Cord P119 741-4232
8 Tube for sipper 741-0820
9 Label PMT-HV 741-1954
10 Circuit board assy PMT-SHV 741-5024
11 Holder 741-1805
12 Support 741-1803
13 Front cover 741-0618
14 Heat-Insulating case 741-0617
15 Tube B for measuring cell 741-0822
16 Cord P600 with micro-cooler 741-4400
17 Cord J600 assy with motor 741-8551, 741-4317
Cord J601
18 Cover 741-0619
19 Cord J601 741-4317
20 Photomultiplier tube 741-1827
Figure 4.4-46 Detection unit cross-sectional view with slanted PMT housing

Figure 4.4-47 Details of Measuring Cell Mounting (PMT Holder) MC fixing
1 CELL FRAME (P/N:741-1832)

2 FLOW CELL ASSY (P/N:741-0461)

Figure 4.4-48 Details of Measuring Cell Mounting (PMT Holder) Support Fixing
1 SUPPORT (P/N:741-1803)
2 CELL FRAME (P/N:741-1832)
3 FLOW CELL ASSY (P/N:741-0461)

Figure 4.4-49 Top view of detection unit

Figure 4.4-50 Rear view of detection unit
4.4.13.3 Measuring Cell
The measuring cell has 2 (two) separable components as shown in Figure 4.4-51.
1. Cell body
2. Reference electrode (RE)
Preparation of the Measuring Cell
• RE is originally covered with a cap. On use, it should be detached by unscrewing.

• Attach the RE into the cell body by screwing firmly.
• Connect the plug into the RE terminal.
• The ECL signals are obtained through PMMA window (see Figure 4.4-51).
As the window tends to become dirty, be sure not to touch it with your bare fingers.

Figure 4.4-51 Assembled measuring cell
1 PMMA Window
2 Cell Body
3 RE (Reference Electrode)
4 Connector J610
Replacement of Measuring Cell
1 ► Make sure that the instrument is switched off.

2 ► Remove the lid of the detection unit by unscrewing the 2 (two) M3 screws located on the
rear cover.
3 ► Remove the detection unit cover by unscrewing the 6 (six) M3 screws.
4 ► Detach the inlet/outlet tubes from the measuring cell by unfastening their nipples.
5 ► Detach connector J610 from connector P610.
6 ► Unfasten 2 (two) M3 screws.
7 ► Slide the measuring cell base forwards and then downwards.
8 ► Detach the measuring cell itself by unfastening 2 (two) M3 screws located on the base.
9 ► Replace the measuring cell by a new one.
10 ► Slide the measuring cell base upwards and then backwards into the detection unit.
11 ► Replace the 2 (two) M3 screws.
12 ► Replace the inlet/outlet tubes and the connector.
13 ► Replace the covers.

14 ► Switch the instrument on.

15 ► Refer to Chapter 2.3.9 for details concerning conditioning of the measuring cell.
When to replace the measuring cell
1 ► The measuring cell should be replaced if the measuring cell position relative to the PMT
and magnet is correct and the BSR2 mean value is lower than an acceptable limit
specified by RD/Hitachi
2 ► After six (6) months or 50,000 cycles if TSH values are out of the acceptable range as
specified by RD/Hitachi.
3 ► If there is no mechanical/electrical trouble but the result of the Performance Check
shows abnormal behavior within the warranty term according to the specification
between RD and Hitachi.
4.4.13.4 PMT (Photomultiplier Tube)
• The PMT in the cobas e411 has the following specifications.

• The figures below show side views of the PMT and PMT socket.
• The PMT is very sensitive to environmental lighting and magnetic fields, and must be treated
with great care. Whenever you open the cover of the detection unit, be sure to avoid direct
irradiation by light and sunshine.
• Be sure not to touch the window of the PMT with your bare fingers.
Specification of PMT R1617-05
Table 4.4-13
Description Specifications
Photosensitive window Head-on type
Photocathode material Multialkali
Spectral response range 300-850 nm
Peak wavelength 420 nm
Anode-to-cathode supply 1250 Vdc
(Max.)
Anode-to-last dinode voltage 250 Vdc
(Max.)
Average anode current 0.1 mA
Storing environmental -80 ~ +50°C
temperature
Cathode sensitivity (Sk) ≥120µA/lm
Anode sensitivity (Sp) ≥200 A/lm
Equivalent dark current 5 nA

Description Specifications
(Sp=200A/lm)
Red/white ratio (R/W) 150 X 10-3
Figure 4.4-52 Side view of PMT

Figure 4.4-53 Side view of PMT socket assembly
Replacement of PMT

2 ► Remove the lid of the detection unit by unscrewing the 2 (two) M3 screws located on the
rear cover.
3 ► Remove the detection unit cover by unscrewing 6 (six) M3 screws.
4 ► Detach the inlet/outlet tubes from the measuring cell by unfastening their nipples.
5 ► Detach the connector J610 from the connector P610.
6 ► Unfasten 2 (two) M3 screws.
7 ► Slide the measuring cell base forwards and then downwards.
8 ► Detach the fixing frame from the PMT socket by unfastening the screw.
9 ► Detach the PMT holder with the PMT and the PMT socket.
10 ► Remove the PMT and the PMT socket from the PMT holder.
11 ► Remove the PMT from the PMT socket.
12 ► Insert a new PMT.
13 ► Attach the PMT, the PMT socket, and the PMT holder as before.
Note: Make sure that the PMT window reaches the rubber cushion at the bottom of the PMT
holder.

14 ► Attach the PMT holder to the measuring cell base.
Note: Push the PMT socket tail lightly to ensure sufficient fixing f the PMT window, and attach
the fixing frame of the PMT socket by fastening the screw.
15 ► Slide the measuring cell base upwards and then backwards into the detection unit.
16 ► Replace the 2 (two) M3 screws.
17 ► Replace the inlet/outlet tubes and the connector.
18 ► Replace the covers.
19 ► Switch the instrument on.
CAUTION
• PMT replacement must be carried out in

subdued lighting.
• The PMT window must be cleaned.
• Use clean gloves when you handle the

PMT.
• Allow 1 (one) hour stabilization time.
4.4.13.5 Replacement of Sipper Tubing

2 ► Remove the rear cover by unscrewing the 2 (two) M3 screws.
3 ► Remove the detection unit cover by unscrewing the 6 (six) M3 screws.
4 ► Detach the inlet/outlet tubs from the measuring cell by unfastening their nipples.
5 ► Detach the other side of the inlet/outlet tubs by unfastening their nipples.
6 ► Attach the new tubs firmly by fastening their nipples as before.
CAUTION
• In order to avoid liquid leakage from the

nipples, the tubes must be inserted straight
and firmly.
• Check that none of the nipple screws are

damaged.
4.4.13.6 Replacement of Detection Unit

2 ► Remove the rear cover by unscrewing the 2 (two) M3 screws.
3 ► Unfasten the four (4) screws locate at the feet of the detection unit itself.

4 ► Detach the inlet tubing from the sipper probe by unfastening the nipple.
5 ► Detach the outlet tubing from branch block located on the syringe unit by unfastening
the nipple.
6 ► Disconnect wires and cables attached to the outside connector.
7 ► Replace the detection unit by a new one.
8 ► Replace the four (4) screws.
9 ► Replace the inlet/outlet tubs and the connectors.
4.4.13.7 Housing
Disassembly/ reassembly of detection unit
Disassembly
• Similar to the procedure described in 4.4.14.6.

• Each component will be separated during disassembly procedure.
Reassembly
• Follow the disassembly procedure in reverse.
Casing
The detection unit is equipped with heat insulating casing for temperature control. White polymer
foam sheets are glued to the outer surface of the unit casing. Black polymer sheets are also
applied around the unit cover and the service window to shield from light. The entire casing must
be replaced if the polymer sheets are damaged or come off the casing over a wide area.
PMT stabilization time
Following disassembly/reassembly, of the Detection Unit, one hour is needed for stabilization of
the PMT,
4.4.14 Magnet Drive Mechanism
4.4.14.1 Overview
The magnet drive mechanism is used to position the magnet at the detection point of the
measuring cell and to take the magnet away from the cell.
4.4.14.2 Location
The magnet drive mechanism is located in the detection unit below the measuring cell.
See Chapter 4.2.

The magnet drive mechanism consists of the following components:

Magnet Drive Mechanism is driven by a stepping motor which rotates in 2W, 1-2 phase, bipolar
microsteps, the magnet driving mechanism rotates the arm fixed to the magnet by 90 ° from the
home position to move it to and from the detection point of the measuring cell.
Step angle 0.225°/step
Rotation angle 90 °
4.4.14.4 Detailed Diagram
Figure 4.4-54

4.4.14.5 Parts List
Table 4.4-14

1 HEAT-INSULATING 741-0617
CASE
2 FRONT COVER 741-0618
3 COVER 741-0619
4 HEATING PIPE 741-0669
5 BUSH B 741-1383
6 SHIELD CASE 741-1808
7 PC COVER 741-1810
8 PACKING 741-1814
9 RETAINER 741-1820
10 BUSH HV 741-1822
11 PHOTOMULTIPLIER 741-1827
TUBE
12 GASKET 741-1835
13 BASE 741-1842
14 BASE 2 741-1843
15 CORD GND (HV) 741-4329
16 CIRCUIT BOARD ASSY 741-5024
PMT-SHV
17 FRAME ASSY 741-8549
18 PMT SUPPORT R 741-8679
19 TRAY R 741-8680
20 EPOXIDE RESIN 910-50 F440079
21 SOCKET J831873
23 BUSH NB-400 (BLACK) L938317
24 COLLAR NA407 (BLACK) L938319
25 COLLAR NA-420 L938322
(BLACK)
26 CIRCUIT BOARD L- R629243
AMP(3)
27 Cord J600 Assy With 741-8551
Motor (Thermistor)

4.4.14.6 Assembly and Disassembly Procedure
Removing the Unit
1 ► Remove the rear cover.

2 ► Remove the detection unit from the main unit (base (00) assembly) by taking out three
(3) nipples, three (3) connectors, four (4) screws, and four (4) spacer DEs.
Reassemble the unit by re-installing the parts disassembled in steps 1 and 2 in the reverse order.
Adjustment of the position is not necessary
1. Magnet Drive Assembly

2. J600 Cord Assembly
3. Photo Interrupter (GP1A34LC)
Magnet Drive Assembly
1 ► Remove the main cover assembly by removing six (6) screws from it and then remove
the service cover assembly by removing four (4) screws from it.
2 ► Take out the L-AMP PI assembly together with the shield case LOG by removing the
three (3) connectors and one (1) screw.
3 ► Remove the cell holder, PC cover, and PMT-HV PI assembly in this order. (You need to
remove three (3) screws from the cell holder, one (1) screw from the PC cover, and four
(4) screws and one (1) connector from the PMT-HV PI assembly.)
4 ► Remove the PC base and PC base (2) by unscrewing two (2) screws from each.
5 ► Remove the P600 cord assembly by taking out two (2) M2.6 screws and one (1) cramp.
6 ► Remove the micro cooling unit and then the P601 cord assembly by unscrewing four (4)
screws and two (2) M2.6 screws.
7 ► Remove the four (4) screws (screw a) that secure the main frame assembly to the case
insulation assembly.
8 ► Slide the main frame assembly, support frame, cell frame, and pipe assembly together
with the lead wire of the photo multiplier out of the case insulation assembly. (Unscrew
two (2) M4 screws and two (2) M3 screws.) Be careful not to expose the photomultiplier
to light.
9 ► Remove the magnet drive assembly by unscrewing two (2) screws.
10 ► Remove the J600 cord assembly by removing two (2) locking fixtures, two (2) tie wraps,
and one (1) screw.
Assembly Procedure

Reassemble the unit by re-installing the component removed during the disassembly procedure
in the reverse order.
Note: When reassembling the unit, generously apply Amicon epoxy resin (F440079) to the bottom
(b) of the micro cooling unit. Also, thickly apply Amicon epoxy resin in groove (c) of the main
frame where the pipe assembly is to be mounted.
Note: After removing the magnet drive assembly from the unit, adjust the positions of the magnet
drive and the measuring cell position. Refer to Chapter 5.2.1, Replacement of Measuring
Cell.
J600 Cord Assembly
Replace the J600 cord assembly.
Assembly Procedure
Re-install the parts removed in the disassembly procedure in the reverse order.
Photo Interrupter (GP1A34LC)
► Replace the photo interrupter (GP1A34LC).
Assembly Procedure
► Re-install the parts removed in the disassembly procedure in the reverse order.
4.4.14.7 Adjustment Procedure for Magnet Position
1 ► Switch off the instrument.

2 ► Take out measuring cell from the cell plate as described above.
3 ► Attach the positioning tool to the cell plate in the same manner as for the measuring cell.
4 ► Loosen two (2) screws for magnet driver in rear part of cell plate.
5 ► Move magnet arm upwards and insert the magnet part of magnet arm in the hole of
positioning tool.
6 ► Tighten the two (2) screws for magnet driver.
7 ► Take out the positioning tool.
8 ► Attach measuring cell to cell plate.
9 ► Follow the procedure for cell replacement and close the cover and lid of the detection
unit.

4.4.15 Matrix BCR Mechanism
4.4.15.1 Overview
The matrix BCR mechanism is a unit that contains a rotating mechanism that is used for scanning
bar-coded data with a bar-code reader. The bar-code reader scans a bar code attached to a
sample tube, or a reagent rack pack, or scans a bar-code card that carries the information of
these three in combination.
4.4.15.2 Location
See Chapter 4.2.
The matrix BCR mechanism consists of the following components:
• Rotating Unit
• Bar-code Reader
• Bar-code Card Holder
Rotating Unit
The rotating unit rotates and shifts the bar-code reader to the scanning point on either the sample
disk or the reagent disk. This unit conveys the movement of the stepping motor via a flat gear to
the bar-code reader so that the bar-code reader will rotate slowly when scanning a bar-code card.
Slow Down Rate 1: 8.438
Motor Stepping Angle 0.225 °/step to 0.9 °/step
Shifting Angle 0.027 °/step to 0.107 °/step
Bar-code Reader
The bar-code reader is installed onto a molded bracket at a gear fixed to the bracket with a screw.
The gear controls the rotation of the bar-code reader. The bracket is supported by a rotating axle
which is inserted into ball bearings.
Bar-code Card Holder
The bar-code card holder supports the table cover L and also guides a card into the appropriate
card position.

Figure 4.4-55
Figure 4.4-56 bracket（P/N：741-1321）

Figure 4.4-57 barcode reader Assy（P/N：741-0133）
1 WIDE BCR
2 741-1321: bracket
4.4.15.5 Parts List
Table 4.4-15

1 Base BCR 741-1320
2 Bracket 741-1321
3 Holder 741-1322
4 Motor Base Assy 741-0600
5 Motor Gear 741-1323
6 Shaft 741-1324
Removing the Matrix BCR Unit
Before removing the matrix BCR unit, remove the following covers:
• Rear cover
• Gripper Y cover
• Front cover
• R lid
• Table cover L
• Table cover R
• P plate assembly (at the front bottom of the pipetter unit)

Then, remove three (3) screws, two (2) connectors (P650 and P651), and the bar-code reader
cable connector from the relay board (UI-RS) and remove the unit from the main unit base.
Disassembly and Assembly of the Matrix BCR Unit
1 ► Remove the bar-code reader.

1.1 ► Remove four (4) screws.
2 ► Remove the motor.
2.1 ► Remove two (2) screws.
3 ► Remove the rotating axle from the BCR bracket.
3.1 ► Remove one (1) screw.
4 ► Pull out the rotating axle from the BCR base.
Assembly Procedure
Assemble the Matrix BCR Unit by re-installing the parts removed disassembly procedure in the
reverse order.
If you have removed the motor, re-adjust the backlash of the gear, referring to the diagram below.
Adjustment of Backlash.
First, make the BCR bracket rotate and shift to the stopper positions at both ends to fix the
stopper for the motor gear rotation. Then, adjust the backlash of the BCR bracket in the direction
of its circumference to 0.1 to 0.2 by shifting the motor position.
Figure 4.4-58
4.4.15.7 Adjustment Procedure for BCR
Overview
• The BCR base positions itself. It is not necessary to adjust it mechanically because there is
enough tolerance.
• If you replace the BCR itself, first you just make sure whether it is possible to read a label
according to the Check Procedure.

Check Procedure
Check that the BCR functions well as follows. Refer to attached flow diagrams.
Sample BC Scanning
• Place a Sample Rack with primary tubes to all of which BCR labels are attached.
• Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the
screen.
• Perform Sample BC Scanning by touching the button in the Mechanism check screen. Refer
to Chapter 6.3.
• Confirm whether you hear a beep at each position during scanning.
If everything is OK, the BCR reader is ready for further checks, e.g. Barcode Card Reading and
Reagent Pack BC Scanning. See Comment 1.
If not OK, begin BCR adjustment as described in the Adjustment Procedure.
• Stop Sample BC Scanning by pressing the STOP button.
Barcode Card Reading
• Place a Barcode Card into the Barcode Card Holder.

screen.
• Perform Barcode Card Reading by touching the button in the Mechanism check screen. Refer
to Chapter 6.3.
• Confirm whether you hear a beep during reading.
If everything is OK, the BCR reader is ready for further checks like Reagent Pack BC Scanning.
• Stop Barcode Card Reading by pressing the STOP button.
Reagent Pack BC Scanning
• Place a Reagent Rack with RackPacks to all of which BCR labels are attached.
screen.
• Perform Reagent Pack BC Scanning by touching the button in the Mechanism check screen.
Refer to Chapter 6.1.10. See Comment 2.
• Confirm whether you hear a beep at each position during scanning.
If everything is OK, the BCR reader is ready for operation.

• Stop the Reagent Pack BC Scanning by pressing the STOP button.

Adjustment Procedure
Sample ID
This procedure adjusts the angle of BCR itself relative to slit of the Sample Disk at Sample
position.
The BCR angle moves one (1) pulse by touching the button once in the popup screen (Figure
4.4-59).
In the meantime, find a beep area within ca. ± five (5) pulses of the zero (0) value.
In principle, you do not have to adjust the angle of the Sample Disk rotation, even though the
function is available.
∗ Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.
∗ Touch the Utility button.
∗ Touch the Adjustment Sipper, Cap Open/Close BCR button.
∗ Touch the BCR Sample DIsk button.
1 ► Perform the BCR adjustment as follows.

2 ► Having touched the button, a popup appears (Figure 4.4-59).
Figure 4.4-59 Popup screen of BCR & S.disk
3 ► In the meantime, the BCR continuously scans at half (0.5) second intervals. If
everything is OK, the BCR beeps. It is now ready for further checks like those in item4
►. If not OK, the BCR does not beep; adjust the BCR as described in items 5 ► to 6
►.
4 ► Check whether the BCR can be read when you move the Sample Rack by hand by
about 2 mm to the left or right. See Comment 3.
If everything is OK, the BCR beeps. It is ready for check of retry function. Touch Cancel button. In
not everything is OK, the BCR does not beep; repeat from items 5 ► to 6 ►.
5 ► Adjust the BCR angle to find a beep area within ca. ± five (5) pulses of the zero (0)
value by touching the following buttons.
Note: If you touch the BCR Right + button once, the BCR moves one (1) step to the right.
Note: If you touch the BCR Left - button once, the BCR moves one (1) step to the left.
See Comment 4.
6 ► Confirm that the BCR beep is stable. If it is stable beep, touch the OK button. In the
meantime, the BCR returns to the HOME position (in reset status) once and it moves to
an updated position, the BCR scans again.
If everything is OK, the BCR beeps. It is now ready for operation. See Comment 5. In not
everything is OK, the BCR does not beep; repeat from items 5 ► to 6 ►.
Check Procedure of Retry function of Sample ID—See Comment 6
• There is a BCR Retry function during Sample BC Scanning in operation.

• If the BCR is not readable at first, S. Disk rotates ca. 2mm to the right (CW) and it performs a
second reading.
1 ► Check the Retry function by setting up a BCR position equivalent to the position of the
second reading as follows.
► Make sure that the instrument is in Stand-by status.

► Touch the BCR S. Disk button.
► Touch the button, then a popup appears (Figure 4.4-59).
► Touch the BCR Left - button ten (10) times.
► Confirm that the BCR beep is stable.
In case of all: If it is stable beep, touch the Cancel button. Perform the Sample Scan.
In case of all: If it is not OK, touch the Cancel button and repeat from items 5 ► to 6 ► of
Sample ID.
2 ► Confirm that the Retry function works well as follows.
► Perform a Sample Scan by touching the Sample Scan button in the Orders screen.
► Momentarily block the first Sample Scan with paper; remove the paper and check that
the second Sample Scan is performed.
See Comment 7.
See Comment 8
Reagent ID
• The BCR has a sufficiently wide angle of readable area. Therefore, in principle, it is not
necessary to adjust even though an adjustment function is available.
• The adjustment value is to set zero (0) during production. See Comment 9.
Attachment 1
Comment 1
Some customers are using narrow width barcodes (out of specification) and primary tubes
(diameter 13mm) that rotate with rotation of the sample disk. Therefore, please check sample BC
Scanning by using the adjustment procedure for Sample ID.
Comment 2
Before you perform Reagent Pack BC Scanning, check that the window of the Reagent Jacket is
clean. If you find any stains, clean the window.
Comment 3
(4)’ Check whether the BCR can be read when you touch the BCR Right +button three (3) times
and touch the BCR Left - button three (3) times.
Comment 4
(5)’ If you cannot find a beep area within ca. ± five (5) pulses of the zero (0) value, adjust the
sample disk position by touching the following buttons.
Note: If you touch the Sample Disk Right + button once, the sample disk moves one (1) step to the
right (CW).
Note: If you touch the Sample Disk Left - button once, the sample disk moves one (1) step to the
left (CCW).
Comment 5
Return to (4) and (4)’ (comment 3) for checking.
Comment 6
You need to set up function status of barcode reading on the Data Disk if you want to use the
Retry function.
Comment 7
If everything is OK, the BCR beeps and it is now ready for operation.
If not OK, the BCR does not beep; repeat Sample ID adjustment after checking for stains on the
Barcode label itself.
Comment 8
Barcode Card

• The BCR has a sufficiently wide angle of readable area. In principle, it is not necessary to
adjust.
1 ► Change angle of the barcode holder.

2 ► Confirm whether you hear a beep by using the check procedure for Barcode Card
Reading.
Comment 9
∗ Make sure that the instrument is in Stand-by status by checking that Stand-by appears on the screen.
∗ Touch the Utility button.
∗ Touch the Adjustment Sipper, Cap Open/Close BCR button.
∗ Touch the BCR Reagent DIsk button.
1 ► Perform the BCR adjustment as follows.

2 ► Having touched the button, a popup appears (Figure 4.4-60).
Figure 4.4-60 Popup screen of BCR & R. disk
3 ► In the meantime, the R. Disk rotates continuously and the BCR scans.
If everything is OK, the BCR beeps; it is now ready for further checks like the Retry function for
Reagent ID. Touch the Cancel button.
In not everything is OK, the BCR does not beep; adjust the BCR angle as described in item (4).
4 ► Adjust the BCR angle to find a beep area by touching the following buttons.
If you touch the BCR Right + button once, the BCR moves one (1) step to the right.
If you touch the BCR Left - button once, the BCR moves one (1) step to the left.

5 ► Confirm that the BCR beep is stable.
If everything is OK, the BCR beeps; it is now ready for further checks like the Retry function for
Reagent ID. Touch the OK button.
If not OK, the BCR does not beep; return to item (4).
Check Procedure for Retry function of Reagent ID
• You need to set up function status of barcode reading on the Data Disk if you want to use the
retry function.
• The BCR Retry function is in operation during Reagent BC Scanning.
• If the bar code is not readable at first, the R. Disk rotates again and a second reading is
performed.
1 ► Confirm that the Retry function works well as follows.
► Perform the Reagent Scan by touching the Reagent Scan button in Inventory screen.
► Momentarily block the first Sample Scan with paper; remove the paper and check that
the second Sample Scan is performed.
If everything is OK, the BCR beeps. It is now ready for operation.
In not OK, the BCR does not beep; repeat Reagent ID adjustment, after checking for stains on
the window and on the Barcode Label itself.
Attachment 2
Flow Diagram for BCR Adjustment

Figure 4.4-61
Sample ID Adjustment
Figure 4.4-62

Note: In principle, you do not have to adjust the angle of the S.Disk rotation.
Bar code Card Adjustment
Figure 4.4-63
Reagent ID Adjustment
Figure 4.4-64
4.4.16 SIPPER SAFETY COVER (INTER ROCK Mechanism)
4.4.16.1 Overview
The INTER ROCK Mechanism is a function that stops the device by opening the cover when the
operation and resetting it and does safely.

4.4.16.2 Location
See Chapter 4.2.
• If you open the cover, instrument status changes to STOP by the detector.
• It stops the motor of Sopper X at the same time (by Switch)
Figure 4.4-65

4.5 Mechanical Adjustment
4.5.1 Overview
The following is detailed procedures for adjusting the mechanical positions. The procedures are
described in the order in which you can carry out the adjustments most conveniently.
1 ► Make sure that the mechanical positions of the unit which you have just replaced or adjusted
are well adjusted relative to those units that share the same working areas with the unit. For
instance, when you replace the reagent disk, you should make sure that it is well adjusted
relative to the cap opener, pipetter and beads mixer.
2 ► The belt tension must always be adjusted prior to the position adjustment by means of the
software because you have to take the units out when you adjust their belt tension.
3 ► Refer to Chapter 6.4.1 for general procedures on how to operate the mechanical adjustment
software.
4.5.2 Mechanical Adjustment Procedure

See pdf\4.5_MechanicalAdjustmentProcedure.pdf for more details
4.5.2.1 Adjustment of Gripper Head

This procedure describes how to adjust Carrier ZE ASSY (P/N:741-0412) to align perpendicularly to
the analyzer.
1. The following jigs are used (Figure 4.5-1 and Figure 4.5-2).
Figure 4.5-1 JIG-1 (P/N:741-8219)
Figure 4.5-2 JIG-2 (P/N:741-8218)
2. As shown in Figure 4.5-3, place the JIG-1 in the magazine container. Then, by using the JIG-2,
check visually that the gripper cover stands perpendicularly to the magazine container. If it is not,
perform an adjustment by unfastening the two screws (Screws-A) shown in Figure 4.5-4.

Figure 4.5-3 Visual checking (1)
Figure 4.5-4 Position adjustment (1)
3. As shown in Figure 4.5-5, place the JIG-1 in the magazine container. Then, by using the JIG-2,
check visually that the gripper cover stands perpendicularly to the magazine container. If it is not,
perform an adjustment by unfastening the two screws (Screw-B) shown in Figure 4.5-6, and if
necessary, the two screws (Screws-C) shown in Figure 4.5-7. If you have performed an
adjustment by unfastening the Screws-C, open the inspection hole cover and check if the gears
are engaged smoothly; the Gripper Assy(Figure 4.5-7) must returns to its original height by the
action of the spring when you press it down from above. If the gears are not engaged smoothly,
perform an adjustment by unfastening the screws that secure the motor (Figure 4.5-7).
Figure 4.5-5 Visual checking (2)

4.5.2.2 Adjustment of Vessel Waste Pos.

1. A Vessel Waste Guide (P/N 741-8835) is added to TABLE COVER R (P/N 7410-8586).
2. The screw holes of TABLE COVER R are enlarged and the TABLE COVER R position adjustable.
Figure 4.5-8
3. Adjustment procedure of TABLE COVER R
1 ► Prepare the TABLE COVER ADJUSTMENT TOOL (P/N 741-8813).

Figure 4.5-9 TABLE COVER ADJUSTMENT TOOL (P/N 741-8813)
2 ► Remove COVER Z (P/N 741-8534).
Figure 4.5-10
3 ► Prepare the 1 tip, 2 vessels, 3 tip magazines, and 3 vessel magazines. Set them as shown
in the pictures below.
Figure 4.5-11

Figure 4.5-12
4 ► Touch the [START] button and the instrument starts the initialization.
5 ► About 1 minute later, the vessel on CB Pos. will be discarded by the gripper. The moment
the gripper is over the vessel waste hole, open the SS cover in order to stop the gripper
movement right on the spot. Be careful NOT to be late.
6 ► Remove the vessel and set the TABLE COVER ADJUSTMENT TOOL (P/N 741-8813) to
the gripper as shown in the picture below.
(*Instrument status is Stand-by)

(** Smaller side should be placed upward)
(*** Never moves the X-Y position of gripper when remove the vessel or set the tool)
Figure 4.5-13
7 ► Push the gripper down toward the vessel waste hole by your finger, and check if the
adjustment tool does NOT come into contact with the inner wall of the Vessel Waste Guide.
Adjust Vessel Waste Guide so that Tool may become the center of Vessel Waste Guide as
much as possible. If it is in contact, adjust the position of TABLE COVER R and Vessel
Waste Guide. Then check it in the same way.

Figure 4.5-14
8 ► Check for interference between TABLE COVER R and the following.
1. FRONT COVER S2 (P/N 741-8052)

2. MAGAZINE TRAY (P/N 741-1130)
3. P CARRIER ASSY (P/N 741-0407)
4. Gripper Y mechanism
► Especially, does not come in contact with the TABLE COVER R when you operate Gripper
Y mechanism and P CARRIER ASSY by the hand.
Figure 4.5-15
9 ► After completing the adjustment of TABLE COVER R and Vessel Waste Guide, attach
COVER Z.
10 ► Pepare the 1 tip for buffer station, 33 vessels for incubator (include the Sipping Pos.), 3 tip
magazines, and 3 vessel magazines.
► Set them at the each position.

► Touch the [START] button and the instrument starts the initialization.
► Adjust it again when the following alarms are generated after disposal operates.
Alarm Code: 18-04-01 Gripper finger didn't close
See pdf\4.5_MechanicalAdjustmentProcedure_2.pdf for more details

4.5.3 Mechanical Adjustment Procedure for Rack Sampler
4.5.3.1 Position of the Adjustment
Figure 4.5-16 Rack Sampler’s Range of Adjustment
4.5.3.2 Mechanical Adjustment Procedures for the Rack Sampler System

See pdf\4.5_3_MechanicalAdjustmentProcedure.pdf for more details
Explanation Adjustment Sample Position
Place a rack with a primary tube (diameter 10 or 13 mm) in rack position one at the STAT position of
rack sampler unit.
Carry out "B line sampling pos." from the screen "Adjustment rack sampler".
Check the current sample position adjustment!
If the pipetter needs correction to left/right (x-axis, see Figure 4.5-17), quit the current screen with
"Cancel" key, change to the "Adjustment pipetter R.Disk" screen and carry out "Pipetter-X S.Disk"
from the screen .

B line sample position
Figure 4.5-17
If the pipetter needs correction in up/down direction (y-axis, see Figure 4.5-17), change the rack
position with "Forward" or "Backward" key.
Note: Note: The hook will only move the rack backwards (see Figure 4.5-17). For forward hook
movement, you have to push the rack by hand to get the actual position.
Note: Note: The range of software adjustment for B line sample pos. is only ± 5 steps because of
the design of the racks (Figure 4.5-18).

cobas e411 rack
Figure 4.5-18
If the range of software adjustment for B line sample pos. is not sufficient, change the sample position
manually. To adjust manually, move the whole sample detector B assembly (see Figure 4.5-19) in the
corresponding direction. The detector B assembly is fasten with two screws on the left and one screw
on the right. After changing the position manually, optimize again with the software (as described
above).
B line sample position, adjustment possibilities
Figure 4.5-19

4.6 Rack Sampler System
Figure 4.6-1 Rack Sampler System
1 Rack Sampler Unit

2 Analyzer
4.6.1 Overview
For details of Photo Sensor and Photo Interrupter indicated by PIxxx, see Chapter 4.3.5.
Figure 4.6-2
4.6.2 Rack Sampler Movement
4.6.2.1 A Line
This line sets the rack in which the samples (maximum 15) are placed to the tray and conveys it to the
B line.
4.6.2.2 B Line
This line accurately conveys the rack that has the samples that have been received from the A line to
the bar code reading position and the pipetting position. After reading the sample bar code and the
rack bar code and after pipetting, the rack is conveyed to the C line (storage unit) or the D line.

4.6.2.3 C Line
This line unloads the rack that has the samples that have been conveyed by the C line to the tray with
the arm used for rack conveying.
4.6.3 A Line
4.6.3.1 Composition
(Stroke : 441 mm Delay : 2 mm Sensor to Sensor : 437 mm, 2778P)
Figure 4.6-3
1. Motor used SM200 : A3339-9212
• 2 phase motor, step angle: 0.9o / full step

• Rated current 1.2A
• Use with 1-2 phase
2. Tray used
• Tray for Rack Sampler (space for 15 racks: 75 samples)

• Construct buffer downstream from Tray (space for 5 racks: 25 samples)
3. (3) Rack Feed Speed
• High-speed feeding: 849.2 PPS (134.8 mm/s)

• Low-speed feeding: 445.2 PPS (70.7 mm/s)
4.6.3.2 Overview of Operation

This line sets the rack in which the samples (maximum 15) are placed to the tray and conveys it to the
B line.
4.6.3.3 Rack Feed Operation
The rack is conveyed when the following requirements are fulfilled on operation:
• That the Rack Feeding Detection (PI212: dark) is not on.

• That STAT samples do not exist and the STAT SW is not on.
• That the Rack that has the samples is not on the tray, Home Detection (PI201:dark) is not on.
• That the Rack Detection for rotation machines are not on, for rack conveyors only.
• That Rack Full detection (PI223: dark) for the C line buffer is not in, for rack samples only.
The Rack Feed Operation is not done at reset.

• When the rack that has the samples is not on the tray and Home Detection is not on, the rack feed
arm returns to the Home Position.
• When the rack that has the samples is on the tray and Home Detection is on, the rack feed arm
leaves the Home Position and then returns to the Home Position.
4.6.2.4 Explanation of Operation
1. Home detection (PI201 detection: dark) interrupts and stops the Home position.
2. Rack feed to the B-Line is interrupted and stopped by the Rack Feed Detection (PI212:dark) or
the Rack Feed End Detection. The rack feed arm returns to the Home Position every time after
the Rack Feed End Detection or the Rack Feed Detection.
3. When a STAT sample (STAT input/output) is received, the STAT sample rack is given priority and
the A line rack feed operation is not executed after moving the B line rack.
4. If Rack Feed End Detection (PI202:dark) enters, it returns to the Home Position and executes the
rack feed operation once more in the next cycle.
• If the Rack Feed Detection enters anew, the operation is continued.

• If the Rack Feed End Detection enters, the alarm (S. STOP) for the Rack Feed End is outputted,
and sampling stops.
5. The LED (green) lights up when addition of trays is possible.
4.6.4 B Line
4.6.4.1 Composition
(Stroke:364 mm+153 mm including 2 mm delay)
Figure 4.6-4
Figure 4.6-5

1. Motor used SM210 P: PH265M-31B-A5
• 2 phase motor, step angle 0.9o / 2 phase

• Use 0.45o / P with 1-2 phase
2. Rack Feed speed: overmoderated pulse 250P (0.237S)
• High-speed feeding: 1917 PPS (304.4mm/s)

• Low-speed feeding: 191 PPS (30.3mm/s)

This line accurately conveys the rack that has the samples that have been received from the A line to
the bar code reading position and the pipetting position. After reading the sample bar code and the
rack bar code and after pipetting, the rack is conveyed to the C line (storage unit) or the D line.
4.6.4.3 Rack Feeding Operation

1. The rack is conveyed when the following requirements are fulfilled during the operation:
• When the Rack Detection (PI212:dark) or the STAT SW is inputted. However, when there is a
detection at the same time, the Rack Detection(PI212) is given priority.
2. The rack is conveyed when the following requirements are fulfilled during reset:
• Home removal is done when Home Detection (PI210: dark) is on

• When Home Detection (PI210: dark) remains on, if there is SW recognition it remains in standby
after moving to STAT rack position (Interrupt half as a result of STAT Detection (PI213:dark by
H.P).If there is no recognition of the STAT SW, Rack Feeding is done when the C line and the D
line are in a condition to carry. After that, it returns to home and then goes into standby. If Home
Detection (PI210: dark) is not attached; it goes into standby after returning to home.
• If Home Detection (PI210: dark) is not attached, Rack Feeding is done when the C line and the D
line are in a condition to convey. After that, it returns to home and then goes into standby.
• The rack prior to reading the bar code should not be a reset rack.
3. The rack is conveyed to the pipetting position when the following requirements are fulfilled. When
the Rack Full Detection (PI223) for the C line buffer is on and when the rack detection for the
rotation mechanism (PI241, P1244) is on, a series of analyses is continued and after the final
sample pipetting of the rack that has been loaded, and until the above detections are canceled, it
will be in a standby mode in that position.

1. In the Home position, it will interrupt and stop when Home is detected (PI260: dark).
2. The bar code reading position detection will interrupt and stop the movement of the bar code
reading position (PI216: dark). The same is true for the movement between samples but from the
5th sample to the bar code position shall be a fixed pulse feed.
3. The Sampling Position Detection (PI215: dark → bright) will interrupt and stop the movement from
the bar code reading position to the pipetting position. Also, the Sampling Position Detection
(PI215: dark → bright) shall interrupt and stop the movement between the samples. Skip
processing shall be done for samples that have no analysis requests and if there are empty
positions. For empty racks, one machine cycle shall be used to process.
4. the Rack Feed End Detection (PI211: dark) will interrupt and stop the movement from the 5th
position to the storage position.
5. By pressing the STAT SW after placing the rack in the STAT rack position, the STAT rack
processing makes the machine recognize that there is a STAT rack. The STAT detection (P1211)
from H.P will interrupt and stop the movement to the STAT rack position. If the STAT SW is
pressed, it will give priority from the rack feed of the A-Line after analysis of all of the samples in
the rack that are currently being processed and will convey the STAT rack.

6. If the STAT SW is pressed when Rack Detection (PI212) is on, the regular rack conveyor rather
than the STAT Rack will be given priority.

4.6.5 C Line
4.6.5.1 Composition
(Stroke : 139 mm Delay : 2 mm Including 2 mm delay)
Figure 4.6-6
1. Motor used SM200 : A3339-9212
• 2 phase motor, step angle: 0.9o / full step

• Rated current: 1.2A
• Use with 1-2 phase
2. Tray used
• Tray for Rack Sampler (space for 15 racks: 75 samples)

• Construct buffer upstream from tray (space for 5 racks:25 samples)
3. Rack Feed Speed
• High-speed feeding: 955.7 PPS (151.7 mm/s)

• Low-speed feeding: 183.1 PPS (29.1 mm/s)

This line unloads the rack that has the samples that have been conveyed by the B line to the tray with
the arm used for rack conveying.
4.6.5.3 Rack Feed Operation

1. The rack is conveyed when the following requirements are fulfilled at operation:
• When the C line is in the Home Position (PI221 detection: dark)

• When the Tray Full detection 1 (PI225 detection: dark) is OFF, the Tray Full detection 2 (PI296
detection: dark) is OFF, the tray detection (PI224 detection: dark) is ON, and the Rack Full
detection (PI292 detection: dark) is OFF. (Feed to tray: Stroke 139 mm)
• When the Tray Full detection 1 (PI225 detection: dark) is OFF, the Tray Full detection 2 (PI226
detection: dark) is OFF, the tray detection (PI224 detection: dark) is OFF, and the Rack Full
detection (PI223 detection: dark) is OFF. (Feed to buffer: Stroke 27 mm)
• When the Tray Full detection 1 (P1225 detection: dark) is ON, the Tray Full detection 2 (P1226
detection: dark) is OFF, the tray detection (P1224 detection: dark) is ON, and the Rack Full

detection (P1223 detection: dark) is OFF. Feed to the tray if the previous unloading operation is
sent to the tray. If the previous unloading operation is sent it to the buffer, then send to the buffer.
• When the Tray Full detection 1 (PI225 detection: dark) is ON, the Tray Full detection 2 (PI226
detection: dark) is ON, the tray detection (PI224 detection: dark) is ON, and the Rack Full
detection (PI223 detection: dark) is OFF. (Feed to buffer: Stroke 27 mm)
• Cannot feed when the Tray Full detection 1 (PI225 detection: dark) is ON, the Tray Full detection
2 (PI226 detection: dark) is OFF, the Tray detection (PI224 detection: dark) is ON, and the Rack
Full detection (PI223 detection: dark) is ON.
Table 4.6-1
Tray
Rack Full Tray Full Tray Full
No. detection Discriminant
Detection 1 PI292 Detection 1 PI294 Detection 2 PI296
PI293
1 ON OFF OFF OFF Can feed (to tray)
2 OFF OFF OFF OFF Can feed (to buffer)
3 ON OFF ON OFF Can feed (to tray or buffer)
4 ON OFF ON ON Can feed (to buffer)
5 ON ON ON OFF Cannot feed
6 OFF ON OFF OFF Cannot feed
7 ON ON ON ON Cannot feed
8 ON ON OFF ON Cannot feed
2. The rack is conveyed when the following requirements are fulfilled at reset:
• When the C line is in the Home Position (PI221 detection: dark), the rack is conveyed in the same
manner as (1).
• When the C line is not in the Home Position , the rack is conveyed in the same manner as (1) after
H.P return is performed.


1. Movement from the 5th position to the storage position(PI221 detection: dark).
2. For regular rack feeding, interrupt stop by the rack feed end detection (PI222 detection: dark) from
H.P. (1 rack shall be fed to the tray.) Returns to Home Position after feeding. However, at the end
of feeding, when both the Rack Full detection 1 and Rack Full detection 2 (PI296 detection: dark)
has entered, a ‘Warning’ alarm goes off. Also, after that, until the Rack Full detection (PI296
detection: dark) goes in, it continues a 1 pitch feed.
3. When both the Tray Full detections are resolved, all of the racks that are in the buffer are fed to a
batch of trays. (feeds a maximum of 5)
4. When both the Tray Full detection and the Rack Full detection (PI223 detection: dark) both go in,
a ‘Warning’ alarm goes off.
5. After that, when both the Tray Full detections have been cleared, analysis automatically starts up
again.
6. When returning to Home after 1 rack is fed, (1 pitch feed) a check on the remaining pulse is done
and checks whether the 1 rack feeding is being performed normally or not.
7. When the Rack Full detection (PI223: dark) for the Buffer is on, rack feeding of the A line is not
done.

5.1 Boards
5.1.1 System Overview
5.1.1.1 General Wiring Diagram

See the next diagram.
Location of boards in the PCB. Rack
Figure 5.1-1 Location
Note: RS CONTD (P/N 741-5074) mounted with EIO3 PCB for Rack Sampler System.
Note: DIST232C (P/N 741-5075) mounted with EIO3 PCB for Disk System.
5.1.1.2 General Wiring Diagram

See pdf\GeneralWiringDiagram.docfor more details
5.1.1.3 Wiring Diagram for Rack Sampler System

See pdf\WiringDiagramforRackSamplerSystem.pdffor more details

5.1.2 Location of Boards

Table 5.1-1 PCB list
PCB Name Part No. Location Primary Function
ECPU550 271-5818 PCB rack 1. CPU board for system control.
2. RS232C x 4 channel equipped.
EECL300 275-0716 PCB rack 1. Temperature control.
2. LLD signal control.
3. ADC function for log amp (DI).
4. Reading current & volt of potentio circuit.
EMOT300 275-0710 PCB rack 1. Motor control function (PPMC)
EIO3 741-5080 PCB rack 1. Solenoid driver.
2. Photo interrupter buffer.
3. DC power failure detection.
DO1 741-5031 PCB rack Pulse motor driver for 2 or 1-2 phase control.
DO2 741-5032 PCB placement plate Pulse motor driver for W1-2 or 2W1-2 phase control
at rear of the energized method -
instrument
Reagent disk : 2 or W1-2 phase
Sample disk : 1-2 or 2W1-2 phase
Magnet drive : 1-2 or 2W1-2 phase
Barcode reader : 1-2 or 2W1-2 phase
DO3 741-5033 Front/side of the 1. Peltier control driver for temperature of reagent disk, incubator,
PCB rack system reagent.
2. Heater control driver for detection unit.
3. DC fan motor driver
DIST-PA 741-5045 In the pipetter unit Distribution of photo interrupter signal and pulse motor signal for
pipetter.
DIST-SA 741-5046 In the sipper unit Distribution of photo interrupter signal and pulse motor signal for
sipper
DIST-TVA 741-5047 In the gripper unit Distribution of photo interrupter signal and pulse motor signal for
gripper unit.
DIST-F 741-5028 Left side of the Fuse and LED for DC+5V, +12V and +24V
instrument
DIST-F3 741-5077 In the DC power 1. +12VDC fuse for DC Power Supply
supply unit 2. +5VDC fuse for EIO board power down monitor
3. +5VDC fuse for DIST-232C or RSCONTD board
RS232C control power.
4. +12VDC fuse for PC unit.
USB-F 741-5078 Left side of the Fuse for current limit at USB power supply of PC
instrument
DIST232C 741-5075 PCB rack Changes TTL level for communication of ECPU to RS232C level
ANG-EP2 741-5068 PCB placement 1. Potentiostat voltage generated
plate at rear of the 2. Conversion of pressure sensor signal
instrument 3. +12VDC for PMT-SHV board
PMT-SHV2 741-5025 On the detection 1. High voltage generator for PMT
unit
L-AMP(3) 741-4806 In the detection unit 1. Log conversion of PMT electric current to voltage
LLD-SA 741-5044 PCB placement plate 1. Liquid level detection of sipper.
at rear of the
instrument
LLD-P3 741-5048 In the pipetter head 1. Liquid level detection of pipetter

Table 5.1-2
PCB Name Part No. Location Primary Function
UIRS-C 741-5081 Left/rear side Connection of RS232C signal for 2-set of BCR, HOST.
of the instrument
MVLB110 271-3907 Under the PCB rack Mother board for PCB rack
S.AB-CE 725-5029 In the AC power unit Surge absorber circuit
DET-A 741-5016 In the gripper Photo interrupter equipped (gripper Y-axis)
DET-B 741-5017 In the gripper Photo interrupter equipped (gripper Y-axis)
DET-C 741-5026 In the solid waste box Photo interrupter equipped (solid waste boxpresence/absence)
DETECT1 736-0824 In the SYRINGE Photo interrupter equipped (syringe)
RS CONTD (for 741-5074 PCB rack(On the EIO 1. Motor control function
R/S) Pcb) 2. Conversion from parallel signals to serial signals
PS CONTA (for 741-5058 In the R/S (Under the Conversion from serial signals to parallel signals
R/S) DO4A Pcb)
DO4A (for R/S) 741-5071 In the R/S 1. Pulse motor driver for 2 or 1-2 phase control
2. Photo interrupter buffer
BCR (for R/S) 741-5056 In the B line Connection of RS232C signal for BCR
PH-D (for R/S) 741-5053 In the B line Photo transistor equipped
PH-T (for R/S) 741-5054 In the B line Photo diode equipped
Note: Part No. and PCB name are different depending on the manufacturing time. Please refer to
Parts List for details.
5.1.2.1 Analyzer
Figure 5.1-2

Figure 5.1-3
Figure 5.1-4

Figure 5.1-5
Figure 5.1-6

Figure 5.1-7

Figure 5.1-8

5.1.2.2 Rack Sampler System
Figure 5.1-9
Note: PS CONTA board (P/N741-5058) is located just behind the DO4A board(P/N741-5071) as
shown in the picture above.
Note: BCR Board (P/N741-5056) and BCR are located at the BCR reading position on the B line in
the analyzer.

Figure 5.1-10
Note: PH-D Board (P/N741-5053) should be mounted with PH-T Board (P/N741-5054) as a pair at
the sampling position in the B-line.

5.2 Power Source
5.2.1 AC Power
• AC lines are only connected to the DC power supply through main switch and noise filter.
• The surge absorber provides protection from electrical surges of more than 600V and is
connected between the main switch and the noise filter.
Figure 5.2-1 Power Supply System Diagram

5.2.2 DC Power Supply
5.2.2.1 Specification of DC Power Supply (For e411)

Range of Input Voltage: Single phase 100VAC～240VAC(85 ∼ 264VAC)
Tolerance of AC frequency 47 ∼ 63 Hz
change:
Inrush Current: 15A/30 A (TYP,at 100VAC),30A/30A(TYP,at 200VAC)
Efficiency: 77% (TYP, at 100VAC,600W)/80% (TYP,at 200VAC,650W)
Safety Regulations: UL60950, C-UL(CSA60950), EN60950, EN50178
Hold-up time: 20 ms (TYP, at 100VAC)
Power Factor: 0.99 (at 100VAC,600W)/0.95(at 200VAC,650W)
Dimensions:
Figure 5.2-2 DC Power Supply for e411

5.2.2.2 Specification of DC Power Supply(For R/S)

Range of Input Voltage: Single phase 100VAC~240VAC(85 ∼ 264VAC)
Tolerance of AC frequency change: 47 ∼ 63 Hz
Inrush Current: 15 A (TYP,at 100VAC)/30A(TYP,at 200VAC)
Efficiency: 81% (TYP, at 100VAC)/83%(TYP,at 200VAC)
Agency Approved: UL1950, C-UL(CSA950), EN60950, VDE0160
Hold-up time: 40 ms (TYP, at 5VDC), 20 ms (TYP, at 24VDC),
Power Factor: 0.99 (at 100VAC)/0.93(at 200VAC)
Ripple Noise: 5V:120mVp-p(MAX,at Ta=0~40°C),
160mVp-p(MAX,at Ta=-10~0°C)24V:150mVp-
p(MAX,at Ta=0～40℃),
180mVp-p(MAX,at Ta=-10~0°C)
(Measured by 20MHz Oscilloscope or Ripple-Noise meter (Equivalent to KEISOKU-GIKEN:RM101))
Overvoltage protection: 5V:5.75V(MIN) 24V:27.60V(MIN)～33.60V(MAX)
Overcurrent protection: 5V:5.25A(MIN) 24V:14.14A(MIN)
Dimensions:
Figure 5.2-3 DC Power Supply for R/S
5.2.2.3 Specification of DC Power Supply(For PC)

Range of Input Voltage: Single phase 100VAC～240VAC(85 ∼ 264VAC)
Tolerance of AC frequency change: 47 ∼ 63 Hz
Inrush Current: 20 A (TYP,at 100VAC)/40A(TYP,at 200VAC)
Efficiency: 85% (TYP, at 100VAC)/88%(TYP,at 200VAC)
Safety Regulations: UL60950-1, C-UL(CSA60950-1), EN60950-1, EN50178
Hold-up time: 10 ms (TYP, at 100VAC)
Power Factor: 0.99 (at 100VAC)/0.93(at 200VAC)
Ripple Noise: 250mVp-p(MAX,at Ta=0～50℃), 300mVp-p(MAX,at Ta=-
10～0°C)
(Measured by 20MHz Oscilloscope or Ripple-Noise meter(Equivalent to KEISOKU-GIKEN:RM101))
Overcurrent protection: Works over 105% of rated
Dimensions:

Figure 5.2-4 DC Power Supply for PC
5.2.2.4 Output Voltage & Adjustment

• The output voltage of the DC power source is preset to the values in the table below.
Table 5.2-1 Preset of DC Power output voltage

Voltage Preset Voltage Check Pin No. Part
+5 V +5.35V±1.0% ( +5.29 ～ +5.40V) Between DIST-F Board TP1 and TP4 e411
+12 V(1) +12.30V±1.0% (+12.17 ～ +12.42V) Between DIST-F Board TP1 and TP5 e411
+15 V +16.00V±1.0% (+15.84 ～ +16.16V) Between DO3 Board TP4 and TP5 e411
-15 V -16.00V±1.0% (-15.84 ～ -16.16V) Between DO3 Board TP6 and TP5 e411
+24 V +24.45V±1.0% (+24.20 ～ +24.69V) Between DIST-F Board TP3 and TP6 e411
+5 V +5.30V±5.0% ( +5.04 ～ +5.57V) Between PS CONTA Board TP11 and TP12 R/S
+24V +24.30V±10.0% (+21.90 ～ +26.70V) Between DO4A Board TP1 and TP2 R/S
+ 12V(2) +12.24V±2.0% (+12.00 ～ +12.48V) Between DC Power Supply +V and -V PC
• To adjust or inspect the voltage turn the variable resistors (shown in the figure below) on the
terminal side of the power supply unit without an electric load. (DC output has sensing line and
voltage is maintained even if the electric load is changed.)
Table 5.2-2 Adjustment of DC Power output voltage

Voltage Adjustment Voltage Tolerance at Terminal Adjust Position Part
+5 V +5.35V±1.0% ( +5.29 ～ +5.40V) VR between +5V and GND terminal e411
+12 V(1) +12.30V±1.0% (+12.17 ～ +12.42V) VR between +12V and GND terminal e411
+15 V +16.00V±1.0% (+15.84 ～ +16.16V) VR between +15V and GND terminal e411
-15 V -16.00V±1.0% (-15.84 ～ -16.16V) VR between -15V and GND terminal e411
+24 V +24.45V±1.0% (+24.20 ～ +24.69V) VR between +24V and GND terminal e411
+5 V +5.30V±5.0% ( +5.04 ～ +5.57V) Refer to Figure 5.2-3 R/S
+24V +24.30V±10.0% (+21.90 ～ +26.70V) Refer to Figure 5.2-3 R/S
+ 12V(2) +12.24V±2.0% (+12.00 ～ +12.48V) Between DC Power Supply +V and -V PC

Figure 5.2-5 Output Terminal Side of the Power Supply Unit

∗ Refer toFigure 5.2-4 for the locations of power source adjustment for R/S

Figure 5.2-6 Side View of the Power Supply Unit

Figure 5.2-7 Wiring Diagram of the Power Supply Unit

5.3 Electronic Modules / Electronic Adjustments
5.3.1 Principle of Temperature Control

The temperature control is performed by the microprocessor ANGCNT on the EECL300 board.
Temperature is controlled by four units by one of the following two methods.
5.3.1.1 Incubator, System Reagent Unit

The unit calculates the control signal using the deviation between the target temperature given by the
CPU and the actual temperature measured at the control point and outputs the signal on the DO3
board. The signal is augmented on the DO3 board, and the system runs electricity to the Peltier or the
heater. The fan is used to maximize the heat release efficiency. As the voltage applied to the Peltier
increases, the fan turns on. No fan is used in the incubator.
Figure 5.3-1 Temperature Control Block Diagram (Incubator, System Reagent)
5.3.1.2 Reagent Disk, Detection Unit

The reagent disk determines the target temperature from the ambient temperature of the reagent disk
unit. The detection unit determines the target temperature from the ambient temperature of the system
reagent unit. The system calculates the control signal using the deviation between the target
temperature and the actual temperature measured at the control point and outputs the signal to the
DO3 board. The DO3 board augments the signal and the system runs the electricity to the Peltier or
the heater. The fan is used to maximize the heat release efficiency and turns on as the voltage applied
to the Peltier increases.

Figure 5.3-2 Temperature Control Block Diagram (Incubator, System Reagent)
5.3.2 Principle of LLD

• The liquid level detector of the cobas e411 detects the change of the static electricity capacity
between the detection electrode and GND before and after its contact with the liquid.
• The structure of the liquid level detector is shown in Figure 5.3-3. The detection electrodes used
for the pipetter are a nozzle tip and a disposable tip made of a conductive material. The sample
disk and reagent disk are also made of a conductive material and are grounded. The detection
electrode used for the sipper is the system reagent unit, and is grounded via the sipper nozzle.
The outer wall of the system reagent unit is shielded.
• When the CPU sends a command to the GPCNT (motor controller) to lower the pipetter (or the
sipper), it also sends a command to the LLD CNT (liquid level detection controller) to start the
liquid level detection. Upon receiving the start command, LLD CNT starts monitoring the signal
output from the LLD-P3 board (or the LLD-SA board for the sipper). LLD CNT processes the
received signal and when the signal is for the liquid surface, it sends a "motor stop" command to
GPCNT. The output and "motor stop" signals from the LLD-P3 board (or the LLD-SA) are
described in Figure 5.3-4 (Figure 5.3-5for the LLD-SA).

Figure 5.3-3 LLD Composition
Figure 5.3-4 Pipetter LLD Signal

Figure 5.3-5 Sipper LLD Signal
5.3.3 Principle of Clot Detection

• Clot detection is a monitoring function of liquid pressure in the pipetter tube when sampling to
detect abnormal situations as a result of a blood clot, fibrin, etc.
• Liquid pressure is detected by a semiconductor pressure sensor and a half bridge circuit on ANG-
EP2 PCB, and this signal is also amplified on ANG-EP2 PCB. Then, the pressure signal (range 0 -
5 volts) is converted to a digital signal by EECL PCB and sent to ECPU 550 PCB.
• The clot detection algorithm is fixed by software parameters in the Data FD.
5.3.4 Adjustment / Check Procedure of LLD/Clot Detection

This describes an adjustment procedure if the following items are replaced or checked.
• Pipetter Probe/LLD-P3 Board

• LLD-SA Board/System Reagent Unit
• Pressure Sensor/Tubing of Pipetter System/ANG-EP Board
Figure 5.3-6
5.3.4.1 Pipetter Probe/LLD-P3 Board
Adjustment of Pipetter LLD Voltage
• Concerning the pipetter LLD voltage monitoring, see Chapter 6.1.8.

• Remove the pipetter head cover as illustrated in Figure 5.3-7.

Figure 5.3-7 How to Remove the Cover from the Pipetter Head
Precondition: Ensure that the pipetter tube is primed
Use a plastic screwdriver to adjust the variable
capacitor on the LLD-P3 PCB
as shown in Figure 5.3-12.
When monitoring the voltage, keep your hands
off the pipetter arm.
1 ► After “Reset”, select “Voltage Monitor” and execute “Pipetter LLD”.
2 ► Adjust the voltage to the minimum value while the pipetter head is at the highest position.
► The voltage without tip has to be below 1.5V (see Figure 5.3-9 for testing position) and the
principle LLD curve (check pos. 1) should be in the recommended range (see also Figure
5.3-8).
3 ► Put a tip onto the pipetter nozzle.
► The voltage with tip should be increased by 0.1 V to 1.5 V (check pos. 2, see Figure 5.3-8).
If the voltage decreases, re-adjust the trimmer so that the voltage increases with a tip.
4 ► Take out the RackPack from positions 1, 17 and 18 on reagent disk.

5 ► Move the pipetter to reagent position 18 by hand. The pipetter should be in the position of
R2 aspiration (see Figure 5.3-10)
6 ► Move the pipetter down to position “A” by hand, see Figure 5.3-10 and Figure 5.3-11 for
detailed position. The tip should not touch any plastic. Memorize the monitoring voltage.
7 ► Move the pipetter down to position “B” by hand, see Figure 5.3-10.
► Make sure that the monitoring voltage increases between 0.3 V and 0.7 V (see Figure 5.3-8).
Figure 5.3-8 Principle LLD Curve , Check Positions

Explanation:
1. Recommended adjustment range
ο Pipettor in upper dead point

ο No Tip attached
2. Pipettor in upper dead point
ο Tip attached
3. Pipettor in pos. A
ο Tip attached
4. Pipettor in pos. B (lower dead point)
ο Tip attached
Figure 5.3-9
Figure 5.3-10

Figure 5.3-11
• If the voltage is OK, touch the Monitoring Stop button in the Voltage Monitor screen.
Figure 5.3-12 Location of the variable capacitor
Adjustment of Pipetter Z Abnormal Detection range
Check the crash sensor signal output by measuring the voltage between the connector pin#A3 of J552
and TP2 (AG) on DIST-PA Board as follows.
• Detach the Pipetter head cover as shown in Figure 5.3-7.

• Make sure that the voltage is 0.5 V or lower (ca.35 mV) under normal conditions, i.e. no crash is
detected.
Note: Keep the current height of the pipetter head. This means that only pipetter probe itself
should go up and down during the next measurements.
• Make sure that the voltage is 0.5 V or lower (ca.35 mV) when the thickness tool (0.8), which is
0.8 mm in thickness, is inserted into the gap between the pipetter probe and the flat place as
shown in Figure 5.3-7.
• Also make sure that the voltage increases up to ca.4.5 V or more (ca.5V) when the tool is
replaced by the 1.2mm thickness tool under the same conditions.
• If the increase is not sufficient, bend the detection plate on the pipetter probe upwards or
downwards with pliers (see Figure 5.3-13).
• Repeat the above procedure until the specification is met.
• Replace the pipetter head cover as before.

Figure 5.3-13 Pipettor Z abnormal detection adjustment
Adjustment of Pipetter Y Direction
• Check the pipetter probe position relative to Tip pos.1 on buffer station, washing station, reagent
disk, sample disk and vessel buffer. All positions should be at the center of the hole in each.
• In particular, if the Y-direction pos. of the pipetter probe is not sufficient on the buffer station when
viewed from the side, adjust the pipetter probe Pos. at the center of Tip pos.1 and the vessel
buffer by unfastening and fastening two (2) screws shown by the arrows in Figure 5.3-14.
Figure 5.3-14 Side View of Pipetter
5.3.4.2 LLD-SA Board/System Reagent Unit

Adjust the LLD-SA only when the LLD-SA board or the system reagent unit is replaced. The LLD-P3
PCB must not be adjusted in any other circumstances.
Adjustment of Sipper LLD Voltage
• Concerning the Sipper LLD Voltage Monitoring, see Chapter 6.1.8.

• Lift the sipper probe up to the upper home position. It is not important where you place the sipper
head between the two horizontal ends as long as the tubing is not detached from the sipper probe.
• Adjust the variable capacitor TC2 on the LLD-SA PCB (Figure 5.3-15) with a plastic or ceramic
tool so that the minimum voltage displayed is 3.50 V or lower.

Figure 5.3-15 LLD-SA PCB
Insulation Resistance between the Aluminum Block and the Shield Plate
• Remove the system reagent unit.

• Disconnect the connector J662.
• Measure the insulation resistance between the aluminum block and the shield plate (outer cover
of the system reagent unit) with a multimeter.
• If the resistance is normal, it goes up beyond the measurable limit of the multimeter.
• If it is low, it will indicate a value below 1,000 kΩ. If low, replace the nozzle or replace the system
reagent unit.
Note: The resistance cannot be measured if connector J662 is connected. Also, damaged wiring
and damaged FPC will cause an abnormality of the sipper LLD function.
5.3.4.3 Pressure Sensor / Tubing of Pipetter System / ANG-EP2 Board

When the installation and pressure sensor or tubing in the pipetter system is replaced, please check
the pressure sensor voltage.
It is not necessary for the P-Sensor 2 Assy to be Adjusted the trimmer resistance on the ANG-EP2
PCB
Check of Pressure Sensor Voltage
• Touch the Pipetter Prime button in the Maintenance screen to start pipetter priming. See Chapter
6.
• Press the Stop key when the Pipetter System has filled with water.
• Concerning the Pressure Sensor Voltage Monitoring, See Chapter 6.
• Leave the instrument for 2 minutes or longer.
• Touch the pressure sensor button in the voltage monitor screen.
• Confirm the pressure sensor voltage to 1.8 ± 1.3 V .
1 Sensor and ANG-EP PCB P-Sensor 2 Assy
ANG-EP2 PCB
2 Adjustment / Check the voltage of 1.8 ± 1.3 V
the pressure sensor After pipetter prime, leave for 2 min. or more.
( No adjustment available )
5.3.4.4 Troubleshooting of LLD function

The LLD may be malfunctioning if it shows any of the following problems:

1. It stops before it reaches the liquid surface.

2. It does not stop at the liquid surface, but goes deep in the liquid.
3. It starts descending from an incorrect position.
Pipetter
Abnormality of the liquid level detection for the pipetter may be caused by one of the following
problems.
Use the following procedures for troubleshooting.
• The insulation resistance of the probe is low.
ο Detach the two (2) wires from the probe.
ο Measure the insulation resistance with a voltage multimeter or any similar device.
ο If the resistance is normal, the resistance goes up beyond the measurable limit of the
multimeter.
ο If the resistance is low, it will be shown by a value below 1,000 kΩ. In this case replace the
pipetter probe.
• The electrical conductivity of the water inside the pipetter tube is too high.
ο Measure the output voltage of the LLD-P3 board twice as follows.
a) With the tubing located inside of the pipetter head connected.

b) With the tubing disconnected.
ο If there is a difference in the output voltage between the former and the latter, the conductivity
of the water could be increased.
ο With the tube connected, move the pipetter horizontally and check the voltage. If the output
voltage varies depending on where the pipetter is located on the horizontal axis, the
conductivity of the water could be increased.
ο If high conductivity is detected, replace the water in the water supply tank by water with
conductivity meeting the specification. Repeat the pipetter prime to clean the flow path.
• The spring of the pipetter nozzle holder is mispositioned.
ο If the spring of the pipetter nozzle holder, which is installed in the upper cover of the pipetter
case, is mispositioned, the inner pipe (detection electrode) and the outer pipe (shield) of the
pipetter become mutually conductive. In such a case, the voltage output from the LLD-P3
board goes up by ca. 10 V.
ο If the output voltage is normal when the cover is open, but it is not when the cover is closed,
mispositioning of the spring may be the cause. In this case, return the spring to the normal
position.
• The board is damaged due to liquid leakage.
• The liquid level is too low or there is no liquid in the container.
• Damaged wiring and damaged FPC will cause abnormal liquid level detection with the pipetter.
Sipper
Abnormality of the liquid level detector for the sipper may be caused by one of the following problems.
• The insulation resistance of the system reagent unit is low.
See Chapter 5.3.4.2.

5.3.5 Functional Details of FRONT SW (Operation Switch)
5.3.5.1 Function of the Front SW

Table 5.3-1
Analyzer Status Function of the Switch
1 Operation SW ON/OFF is ignored.
2 Stand By With SW OFF, status changes to sleep (+24 V off).

With SW ON, status recovers from sleep and the system is reset.
∗ If the switch is turned off during operation and kept off, the analyzer shifts to the sleep status as the operation is
completed and the status changes to stand-by.
To switch off the analyzer
Turn off the front switch. The Sleep window is displayed
Figure 5.3-16
NOTICE
Do not touch Shutdown unless there is a particular
reason to shutdown the analyzer. Otherwise all the
analyzer functions and components will be shutdown.
In case you have mistakenly touched the button, turn
off the circuit breaker once, and then turn it on to revive
the analyzer.
NOTICE
It is highly recommended that you enable the
screensaver. To enable, select Utility -> System and in
the Screen Saver area, touch the On button and set the
activation time by typing in a value within the range of
1-60. For details, refer to Utility menu, Screen Saver
area.

5.3.6 Details of Temperature Control / Troubleshooting of Temp. Units
5.3.6.1 Principle of temperature control

• Temperature control is based on PI control. ANG CNT determines the control parameter for the
peltier or heater by calculating every 100 ms as follows.
• It first calculates the difference (En) between the current temperature of the control point (Tn),
which is the temperature n ∗100ms after temperature control started, and the target temperature
(Ttrg).
(a) En = Tn - Ttrg
• It then sums up Ens to the Esumn .
(b) Esumn = En + Esum(n-1)
• Finally, it determines the control parameter (Vout).
(c) Vout = K1*(K2*En + K3*Esumn) (K1, K2 and K3 are coefficients)
• The voltage of the incubator is limited from 0 V to 5 V, the voltages of other unit are limited within
±5 V.
• The temperature of the reagent disk and the detection unit is influenced by the ambient
temperature around the units. So the target temperatures (Ttrg) for the two units are calculated
according to the formula below. The Ttrg of the R.Disk refers to the temperature around the
reagent disk, and the Ttrg of the detection unit refers to the temperature around the system
reagent unit.
Ttrg = A*Tamb + B (A and B are control coefficients)
Table 5.3-2 Coefficients of Temperature Control

Tamb (Ambient
A B
Temp)
Detection Unit -0.02 28.6 System Reagent unit
Reagent Disk -0.57 30.0 R.Disk
• The fans of the peltier rotate when the voltages (Vout) are more than ca.+1.0 V or less than ca.-
1.0 V.
Note: You can see the temperatures of the control points (Tn), the ambient temperatures (Tamb),
the target temperatures (Ttrg) and the control parameters (Vout) on the Temperature
Monitor Screen.

Figure 5.3-17 Temperature Monitor Screen
Note: The Peltier works as a heater when the control parameter is positive and as a cooler when
the control parameter is negative.
Note: The control parameters (Vout) are multiplied by +1 at the EIO3 board and by -2.6 at the DO3
board. Voltages are limited within ± 12 V on the DO3 board.
Note: The control parameter for the detection unit turns over when it comes to ANGCNT.On the
Temperature Monitor Screen you can see the voltage which does not turn over. It turns over
by the cable (P/N 741-4237) between the DO3 board and the detection unit
5.3.6.2 Troubleshooting
• If temperature below 4.6 degrees C is displayed
1. If temperature control is being normally operated, the temperature displayed in the screen should
be 13 to 15 degree C at the lowest.
2. Therefore, if the screen displays a temperature below 4.6 degrees C, this may be due to the
thermistor wire or the cable between the EECL300 board and the thermistor breaking.
3. What is displayed is identical to that which is displayed if the thermistor resistance were infinite.
• If temperature higher than 80.0 degrees C is displayed
1. If temperature control is normal, the thermostat breaks the input for peltier or heater at around 60
degrees C.
2. Therefore if the temperature is displayed higher than 80.0 degrees C, this may be due to the
thermistor or the cable between the EECL300 board and the thermistor being shortcircuited.
3. This phenomenon is identical to that which takes place if the resistance of the thermistor were
zero (0) ohm.
• If temperature does not meet the specification
1. Check whether covers the are closed or not. For example, temperature control of the R. Disk does
not work well without the R. Disk cover.
2. Check that there was not a steep temperature gradient. The specification of the temperature
gradient is ± 2 degrees C /h. Direct wind from air conditioners, etc., must be avoided.
3. Check the relation between the indication temperature and the ambient temperature of the
thermistor.
1) Check the peltier or the heater if the two temperatures are nearly the same.
2) Check the thermistor if the two temperatures are significantly different.

Because of the thermometer accuracy might be within ± 0.5 degrees C, only a rough comparison is
possible.
• How to check the peltier and heater.
1. Check the resistance between the wires of the peltier or heater to detect any abnormalities in
the element.
2. Measure the resistance at Table 5.3.6-2 shows the check pins of the peltier or heater.
Table 5.3-3 Check pins of peltier or heater

Eleme Pins to
Unit Resistance
nt measure
Detection peltier J603 5pin-6pin Ca. 2.7Ω
R.Disk peltier J523 2pin-5pin Ca. 2.7Ω
J523 8pin-11pin
System peltier J660 4pin-6pin Ca. 2.7Ω
Reagent
Incubator heater J570 3pin-4pin Ca. 7.2Ω
• How to check the thermistor
1. Check the resistance between the wirings of the thermistor to determine whether or not the
thermistor is normal.
2. Thermistor errors are usually caused by moisture.
3. With the usual ambient humidity, the thermistor never absorbs moisture. However, if the
thermistor gets wet as a result of condensation, the resistance of the thermistor goes down
significantly. Therefore, there are no circumstances in which the thermistor only slightly defective,
and so the error is quick to find.
4. Table 5.3-4 shows the check pins of the thermistor.
5. Table 5.3-5 Table 5.3.6-4 shows the outline of the resistances of thermistor.
6. Details are shown in the data sheet for the thermistor.
Table 5.3-4 Check pins for thermistor
Unit Thermistor Pins to measure

Detection Control point J603 4pin-12pin
R.Disk Control point J524 1pin-2pin
Ambient J524 3pin-4pin
System Reagent Control point J661 1pin-2pin
Ambient J661 3pin-4pin
Incubator Control point J571 1pin-2pin
Table 5.3-5 Pl Relation between thermistor resistance and temperature
Temperature
10 15 20 25 30 35 40 45 50
(degrees C)
Resistance (kΩ) 9.9 7.8 6.2 5.0 4.0 3.2 2.6 2.1 1.8
5 6 5 0 3 7 6 8 0

5.3.7 Serial Data Communication
5.3.7.1 General Description

Use a 26 bit parallel data, a shift register and convert for a serial data and transmit/receive it at a
speed of 1250[Kbps].
5.3.7.2 Functional Description
Block Diagram
Figure 5.3-18
Parallel - Serial Conversion
Latch the parallel data, and with the shift register convert to parallel → serial.
Figure 5.3-19
Serial-Parallel Conversion
With the shift register convert the serial data from serial → parallel, and latch the parallel data.

Figure 5.3-20
5.3.8 Adjustment of Mixer Speed

The mixer speed should be measured with a tachometer (Ident No. 1903152) or stroboscope during
each maintenance and whenever the assay performance is insufficient.
Refer to Chapter 2.6.1 for the complete mixer adjustment procedure.
To check the mixer speed, use one of the following procedures:
1 ► Place a reagent pack in positions 1 to n. Start the Bead Mixer Check ( Mechanism Check )
and enter < n > repititions.
2 ► Adujst the speed by the VR ( CW for encreasing the speed )
► Confirm the following mixer speeds using an rpm meter :
Table 5.3-6
In air In liquid
2050 rpm ± 100 rpm 2000 rpm ± 100 rpm
The figure below shows the location of the resistor to be adjusted on the EIO3 PCB (see also Chapter
5.4.4).
Figure 5.3-21

5.4 Printed Circuit Boards

5.4.1 ECPU550 Board
• ECPU550 PCB has SH4 as main CPU and does the central processing of the instrument.
• RS-232C controller (8 channels) also are mounted on the board. (As for e411, RS-232C controller
uses 4 channels at maximum.)
• Main memories are 64MByte-DRAM, and 128KByte-SRAM which are backed up with a battery
(Electric double layer capacitor) for memorizing the instrument’s parameters.
Block Diagram
Figure 5.4-1
Note: This block Diagram is Disk System
Note: Note for EIO3 PCB
∗ Disk System : EIO3 + DIST232C PCB
∗ Rack System : EIO3 + RSCONTD PCB
5.4.1.2 Location
Figure 5.4-2 Location in the PCB Rack
RS-232C Controller
This controller communicates with the following units via UIRS-C PCB.
• Host Computer to receive the Test Order and send back the Measured Results.
• Barcode Reader to Read Rack Pack information and Sample ID.

Battery
• The specifications of the battery (Electric double layer capacitor)are as follows.
Table 5.4-1
No. Description Specification
1 Data holding time during Power off 7 days (with full charge)
2 Recharging time from empty status 24 hours
3 Life time 7 years
• Power Supply of SRAM on the board is provided by a re-chargeable battery during Main Switch off.
LED Description
Table 5.4-2
Silk-print
display During After Reset is
Name Color Meaning Remarks
Reset released
RUN RUN Green Lights-on : Reset is released. Also, Lights-out Lights-on/Lights-out
Double Bus Error is not generated.
Lights-out : During Reset, or, Double
Bus Error was generated.
FAIL FAIL Red Lights-on : Due to Double Bus Error, Lights-out Light is out until the
MPU stopped. new phenomenon
Or, Watchdog Timeup was generatead. (Due to Double Bus
Lights-out : Double Bus Error is not Eror, CPU stopped.
generated. And Watchdog Timeup is Or, Watchdog Timeup
not genrated. was generated.)
occurs.
DMA DMA Green Lights-on : DMA is being transffered. Lights-out Lights-on/Lights-out
Lights-out : DMA is not being
transffered.
INT INT Green Lights-on : The order is changeable Lights-out Lights-on/Lights-out
depending on the priority.
Lights-out : The order is not changeable
depending on the priority.
MBS MBSY Green Lights-on : Memory is accessed. Lights-out Lights-on/Lights-out
Lights-out : Memory is not accessed.
MER MERR Red Lights-on : 2 bit ECC Error was Lights-out Light is out until the
generated. new Phenomenon (2
Lights-out : 2 bit ECC Error is not bit ECC Erros was
generated. generated in Main
Memory) occurs.
DIG DIAG Red Lights-on (For approx. one Second) : Lights-out Lights-on/Lights-out
Self-diagnosing. Lights-on (Every 0.5
second) : Self-diagnose error was
generated.
Consecutive lights-on : Boot error was
genrated.
Lights-out : Not self-diagnosing.
And Self-diagnose error is not
generated.
And Boot error is not generated.
∗ For the error code, LED
registor D31
Dip Switch Setting (SW3: see next page)
Figure 5.4-3

5.4.1.4 Parts Mounting Diagram

The parts mounting diagram for the ECPU550 board is shown below.
Figure 5.4-4

5.4.2 EECL300 Board

This circuit board consists of the following functions.
• Analog Data Controller(H8 ADCCNT)
• LLD Controller(H8 LLDCNT)
Block Diagram
Figure 5.4-5
5.4.2.2 Location
Analog Controller (ANGCNT)
Potentiostat
• The ANGCNT sends the potentiostat voltage twice as high as the order according to the timing
chart for potentiostat which comes from the CPU.
Data Collection
• The luminescence data are converted to logarithmic values in the L-AMP(3) circuit board, then
ANGCNTcarries out analog-to-digital conversion and transmits the data to the CPU.
• GMCNT converts the current running through the cell and voltage between CE and WE from
analog to digital and transmits the data to the CPU.
Temperature Control
• The ANGCNT determines the output voltage to the Peltier and the heater according to the
temperature measured by the thermistor thermometers, and it controls ON/OFF of the fans.

LLD Controller (LLDCNT)
Liquid Level Detection

• LLDCNT determines the liquid level according to the signal from LLD-P3 or LLD-SA circuit board,
sends the interruption signal to GPCNT on the EMOT300 circuit board and stops the motor.
Clot Detection
• LLDCNT takes in the pressure sensor signal from ANG-EP circuit board and transmits the data to
CPU.
• CPU decides whether or not a clot is detected.
LED Description
Table 5.4-3
LED Supplied
Purpose Remark
No. Voltage
RUN 5V CPU running monitor is lit when CPU is
running, other than in HALT status.
INT 5V MPU interruption
CRT 5V
ADC 5V DC bus busy


The parts mounting diagram for the EECL300 board is shown below.
Figure 5.4-7
5.4.3 EMOT300 Board

This circuit board consists of the following controllers and memory.
• GPCNT Motor Controller x ten (10)
• GMCNT DI/DO controller x one (1)

Block Diagram
Figure 5.4-8
5.4.3.2 Location
Motor Control
• GPCNT generates pulse signal, and sends it to DO1 or DO2 circuit board when it receives the
order of drive pattern of motor and pulses from the CPU.
• GPCNT stops a motor when it finishes the pulses ordered from the CPU or it receives the signal
from photo interrupter or the signal of LLD.
DI/DO control
DI function
• The status information from EIO3 circuit board about the power supply watching, fuse detection, tip
detection, R. Disk cover detection, water level watching in the distilled water tank, etc. are written
on GMCNT.
• CPU scans DI at regular intervals, and gets these statuses.
DO function
• CPU writes the status of switching of micro step and static current drive and ON/OFF of SV, beads
mixer, HV, potentiostat and +24V on GMCNT.
• Each driver on EIO3 circuit board or other boards drives them.

Dip Switch Setting
Figure 5.4-10


The parts mounting diagram for the EMOT300 board is shown below.
Figure 5.4-11

5.4.4 EIO3 Board

This circuit board has many functions like wave shaping of sensor signal, driving SV, switching
ON/OFF for HV, detection of fuse blowing on DO circuit board and other boards, signal buffer, driving a
motor for beads mixing, power supply for circuit boards and modules, watching the power supply and
generating the signal for system reset.
Block Diagram
Figure 5.4-12
5.4.4.2 Location

1. Wave shaping and power supply for the sensors
• EIO3 shapes the wave from photointerrupter into TTL level and transmits it to EMOT300 Board.
• The main chips for this function are MDIR1 - 6.
2. Driving SV etc.
• EIO3 drives SV1 - 8, ON/OFF of the pump and the solenoid for gripping mechanism of T/V carrier.
• The main chip is for this function is MP4501 (transistor array).
3. Switching ON/OFF for HV etc.
• EIO3 switches ON/OFF HV, potentiostat, +24V power supply and power supply for DO3 board.
• EIO3 stores the ON/OFF status of GMCNT on the EMOT300 board in the buffer memory and
switches each function.
4. Detection of fuse burning out and abnormal temperature on the DO3 board
• A circuit on the EIO3 board detects that a fuse that is mounted on DO1, DO2, DO3 or EIO3 board is
burned out, and it informs GMCNT on EMOT300 board of the issue.
• A circuit on the EIO3 board also detects an abnormal temperature of a fan on DO3 board, and it
informs GMCNT on EMOT300 board of the issue.
5. Buffer for signals
A circuit on the EIO3 board stores the output signal of peltier and fan from EECL board into the buffer
memory ,and it transmits them to DO3 board.
6. Driving a motor for beads mixing

A circuit on the EIO3 board supplies the power to a DC motor for beads mixing.
7. Power supply for the following printed circuit boards and electronic modules.
• ±12V for LLD - P3 board via DIST - PA board
• ±12V for LLD - SA board
• ±15V for ANG – EP2 board
• ±12V for L - AMP (3) board via ANG – EP2 board
8. Watching the power supply
A circuit on the EIO3 board compares the supplied voltage (V) with the reference voltage (Vref) ,and it
puts LOW level signal out to the EMOT300 board if the supplied voltage (V) is lower than the reference
voltage (Vref).
9. Generating the signal for SYSTEM RESET
• A circuit on the EIO3 board generates the VACFAIL signal according to the ACFAIL signal from DC
power supply and 5V power watch IC (IC17 : MAX791), and it transmits SYSRESET signal to the
ECPU board.
• Following switching on of the instrument, the main CPU is informed by VACFAIL signal,and the
main CPU is reset by SYSRESET signal. When the instrument is switched off, VACFAIL signal cuts
in on main CPU just before DC power supply is off.
Fuses/LEDs Description
Table 5.4-4
Rated Rated Supplied
Fuse No. LED No. Purpose
Current voltage voltage
F1 5.0 A 48 V LED1 5V Power supply for the wave shaping
circuit
LED2 5 V(1) Power supply for photocoupler on SV
driving circuit
F2 Ditto ditto LED3 12 V(1) For driving HV, potentiostat, beads
mixer, +24V ON/OFF
LED4 5 V(2) For controlling HV, potentiostat, beads
mixer, +24V ON/OFF
F3 Ditto ditto LED5 24 V(1) For driving SV5 - SV8
F4 Ditto ditto LED6 24 V(2) For driving SV1 - SV4 and pump
LED7 5 V(3) For controlling SV1 - SV8 and pump
F5 Ditto ditto LED8 +15 V(1) Power supply for LLD-P3, LLD-SA and
L-AMP(3)
F6 Ditto ditto LED9 -15 V(1) Power supply for ANG-EP2 and
EECL300
Dip Switch Setting

Table 5.4-5
JP number Jumper Pin Arrangement
JP1
Figure 5.4-14 2-3pin Jumper

JP2
Figure 5.4-15 1-8, 2-7, 4-5pin Jumper

JP3
Figure 5.4-16 2-7, 4-5pin Jumper


JP4

The parts mounting diagram for the EIO3 board is shown below.
Figure 5.4-18
5.4.5 DO1 Board

The DO1 board has fourteen (14) constant current motor drivers and two (2) constant voltage motor
drivers for the stepping motor and supply current to each motor.

Block Diagram
Figure 5.4-19
5.4.5.2 Location

The motor driving signals from GPCNT on the EMOT300 board are converted to motor driving current
on the DO1 board for the following stepping motors.
Table 5.4-6
No
Motor No. Drive method Function
.
1 SM011 Constant Current 1-2 phase S.DISK rotation
2 SM031 Constant Current 1-2 phase Cap Open / Close (Forward / Back)
3 SM032 Constant Current 2 phase Cap Open / Close (Open / Close)
4 SM041 Constant Current 1-2 phase Beads Mixer (Arm Rotate)
5 SM042 Constant Current 1-2 phase Beads Mixer (Up/Down)
6 SM141 Constant Current 1-2 phase Solid Waste
7 SM051 Constant Current 1-2 phase Pipetter
8 SM052 Constant Current 1-2 phase Pipetter
9 SM081 Constant Current 1-2 phase Sipper
10 SM061 Constant Current 1-2 phase Gripper
13 - - -
14 - - -
15 SM091 Constant Voltage 1-2 phase Pipetter Syringe
16 - - -

Table 5.4-7
Rated Rated LED Supplied
Fuse No. Purpose
current voltage No. voltage
F1 3.2 A 48 V LED1 5 V(1) DC power after photo coupler (PCP)
LED2 24 V(1) Driving power for S.Disk, and Cap Open/Close
(Forward/Backward)
F2 Ditto Ditto LED3 24 V(2) Driving power for Cap Open/Close (Open/Close) and Beads
Mixer Rotation.
F3 Ditto Ditto LED4 24 V(3) Driving power for Cap Open/Close
(Up/Down), S.WASTE
F4 Ditto Ditto LED5 24 V(4) Driving power for Pipetter X axis / Z axis
F5 Ditto Ditto LED6 24 V(5) Driving power for Sipper X axis, and Gripper X axis
F6 Ditto Ditto LED7 24 V(6) Driving power for Gripper Z axis / Y axis
F7 Ditto Ditto LED8 24 V(7) Spare × 2
F8 Ditto Ditto LED9 24 V(8) Pipetter Syringe & Spare

The parts mounting diagram for the DO1 board is shown below.
Figure 5.4-21

5.4.6 DO2 Board

The board has five (5) micro step driver circuits for the stepping motor and supplies current to the
following motors.
Block Diagram
Figure 5.4-22
5.4.6.2 Location
See Chapter 5.1.2.

• The motor driving signals from GMCNT on the EMOT300 board are converted to motor driving
current on the DO2 board.
• Micro step driving (2W1-2 phase or W1-2 phase) and constant current drive will be switched by
control signal from GMCNT on EMOT300 the board.
Table 5.4-8
No. Motor Drive method Function
1 SM021 W1-2/2 R.DISK Rotation
2 SM151 2W1-2/1-2 Barcode Reader Rotation
3 SM082 2W1-2/1-2 Sipper Up/Down
4 SM111 2W1-2/1-2 Magnet Drive
5 SM101 2W1-2/1-2 Sipper Syringe
Table 5.4-9
Rated Rated
Fuse No. LED No. Voltage Purpose
current voltage
F1 3.2 A 48 V LED1 5 V1 DC power for after photo coupler
LED2 24 V1 R.Disk rotation ,BCR rotation
F2 Ditto Ditto LED3 24 V2 Sipper Up/Down, Magnet Drive
F3 Ditto Ditto LED4 24 V3 Syringe (Sipper) Drive


Figure 5.4-23
5.4.7 DO3 Board

The DO3 board is a current driver for the peltier and heater.
Block Diagram
Figure 5.4-24
5.4.7.2 Location
See Chapter 5.1.2

• Control parameter (value is indicated on PC) from ANGCNT on EECL Board is amplified 2.6 times
by EIO3 board & this PCB, and converted to current by the driver circuit for peltier or heater.
• Also, the fan motor for the peltier is driven by this board with ANGCNT signal.

Table 5.4-10
Fuse Rated Rated
LED No. Voltage Purpose
No. current voltage
F1 5.0 V 48 V LED1 5 V1 DC power for photocoupler
LED2 12 V Fan motor
F2 Ditto Ditto LED3 +15 V1 Peltier for R. disk
F3 Ditto Ditto LED4 +15 V2 Ditto
F4 Ditto Ditto LED5 +15 V3 Peltier for measuring unit
F5 Ditto Ditto LED6 +15 V4 Peltier for system reagent unit
F6 Ditto Ditto LED7 +15 V5 Heater for incubator
F7 Ditto Ditto LED8 -15 V1 Peltier for R. disk
F8 Ditto Ditto LED9 -15 V2 Ditto
F9 Ditto Ditto LED10 -15 V3 Peltier for measuring unit
F10 Ditto Ditto LED11 -15 V4 Peltier for system reagent unit
F11 Ditto Ditto LED12 -15 V5 Heater for incubator

Figure 5.4-25

5.4.8 DIST-PA Board

• This board distributes DO1 output signal to the pipetter assembly and connects detector signal
including LLD signal from the pipetter assembly to the EIO3 board.
Block Diagram
Figure 5.4-26
5.4.8.2 Location
See Chapter 5.1.2

The parts mounting diagram for the DIST-PA board is shown below.
Figure 5.4-27
Pipetter Z Abnormal Detection

Check the voltage between Pin# A3( Z-ABN) of J552 and TP2(A.G) with a voltage multimeter.
Pipetter LLD
Check the voltage between TP1(LLD Sig.) and TP2(A.G) with a voltage multimeter.
Supplied Voltage + 5 V on Board

Check the voltage between TP3(5V) and TP2(A.G) with a voltage multimeter.

5.4.9 DIST-SA Board

This board distributes DO1 & DO2 output signal to the sipper assembly and connects detector signal
from the sipper assembly to the EIO3 board.
Block Diagram
Figure 5.4-28
5.4.9.2 Location
See Chapter 5.1.2

The parts mounting diagram for the DIST-SA board is shown below.
Figure 5.4-29

5.4.10 DIST-TVA Board

This board distributes DO1 output signal to following devices, gathers detection signal from the
following devices and connects to the EIO3 board.
Block Diagram
Figure 5.4-30
5.4.10.2 Location
See Chapter 5.1.2.

The parts mounting diagram for the DIST-TVA board is shown below.
Figure 5.4-31
5.4.11 DIST-F Board

This board distributes DC power from DC power supply to MVLB and protects it from the DC power
line.
Block Diagram
Figure 5.4-32

5.4.11.2 Location
See Chapter 5.1.2.
Table 5.4-11
Rated Rated
Fuse No. LED No. Corresponding power Purpose
current voltage
F1 3.2 A 48 V LED1 +5 V(1) For ECPU board
F2 5.0 A ditto LED2 +5 V(2) For EECL board
F3 5.0 A ditto LED3 +5 V(3) For EMOT300 board
F4 5.0 A ditto LED4 +5 V(4) For EIO3 board
F5 3.2 A ditto LED5 +5 V(5) For DO1 board
- - - LED6 +12 V +12 V for MVLB board
- - - LED7 +24 V +24 V for MVLB board

The parts mounting diagram for the DIST-F board is shown below.
Figure 5.4-33
Note: Fuse F4 should be mounted with a rated current of 5.0 A.


Check the supplied voltage with a voltage multimeter as follows.
Table 5.4-12
Fuse No. LED No. Corresponding power Check point Voltage
F1 LED1 +5 V(1) Voltage between TP1 and ca. 5 V
F2 LED2 +5 V(2) TP4.
F3 LED3 +5 V(3)
F4 LED4 +5 V(4)
F5 LED5 +5 V(5)
- LED6 +12 V Voltage between ca. 12 V
TP2 and TP5.
- LED7 +24 V Voltage between ca. 24 V
TP3 and TP6.
5.4.12 DIST-F3 Board

5.4.12.1 Overview
Figure 5.4-34
5.4.12.2 Location
See Chapter 5.1.2.
5.4.12.3 Block Diagram
Figure 5.4-35

Fuse Description
Table 5.4-13
Fuse Rated Rated Supplied
Purpose
No. current voltage voltage
F1 0.5 A 48 V 5V +5 VDC Fuse for EIO3 board power down monitor
F2 1.0 A ditto ditto +5 VDC Fuse for DIST232C or RSCONTD board
F3 5.0A ditto ditto +12VDC Fuse for DC FAN unit (DC Power supply 1)
F4 5.0A ditto ditto +12VDC Fuse for PC unit (DC Power supply 2)
5.4.13 DIST232C Board

Make ECPU550 TTL Signal RS232C voltage.
Block Diagram
Figure 5.4-36
5.4.13.2 Location
See Chapter 5.1.2.

Controlling circuit board for the 2D BCR, BCR, and the HOST.

The parts mounting diagram for the DIST232C board is shown below.
Figure 5.4-37

5.4.14 ANG-EP2 Board

This printed circuit PCB acts as a potentiostat for the measuring cell, amplifier of pressure sensor,
ON/OFF of PMT high voltage and power supply for L-AMP(3) PCB.
Potentiostat
• This circuit has the function of applying constant voltage between RE-WE of the measuring cell by
regulating the current. The voltage is switched by the software. With relay the voltage will be cut off
when the software is not activated.
• Also, there is a function for sending voltage between CE and WE and current for the measuring cell
to the EECL board.
Block Diagram
Figure 5.4-38
Vref : order voltage of potentiostat voltage × (-2)
Vol : voltage between CE and WE
Cur : current for Cell
+12(3) : DC driving power for relay
Amplifier of Pressure Sensor

• The pressure sensor signal is picked up by half of the bridge circuit in the pressure sensor and half
of the bridge circuit on this board, and this signal is amplified and sent to EECL PCB.
• For the adjustment procedure for the bridge circuit see the ANG-EP PCB adjustment procedure.

Block Diagram
Figure 5.4-39
ON/OFF function of PMT-High Voltage

DC power for PMT-SHV PCB and drive signal for relay of PMT High Voltage ON / OFF.
Block Diagram
Figure 5.4-40
+12 V(1) : HV input voltage
+12 V(2) : DC driving power for PMT-SHV PCB.

DC Power Supply for L-AMP(3) PCB

±15V from EIO3 PCB is filtered on this PCB and connected to L-AMP(1) PCB.
Block Diagram
Figure 5.4-41
Table 5.4-14
Rated Rated Corresponding
Fuse No. LED No. Purpose
current voltage power
F1 0.5 A 48 V LED4 15 V LOG-AMP board
LED5 -15 V LOG-AMP board
F2 0.5 A ditto LED3 12 V PMT-SHV board
F3 1.0 A ditto LED1 15 V +15V in PCB for potentiostat
circuit
LED2 -15 V -15V in PCB for potentiostat
circuit


The parts mounting diagram for the ANG-EP2 board is shown below.
Figure 5.4-42
5.4.15 PMT-SHV2 Board

This PCB converts DC+12V to DC-1000V and applies the voltage to PMT.
Block Diagram
Figure 5.4-43
+12 V(1): input voltage for HV
+12 V(2): driving power for PMT-SHV PCB

• When High Voltage ON command is issued by software, the relay will be switched on and DC+12V
will be applied to DDC (DC-DC converter).
• DDC will convert to High Voltage around DC-1000V and it will be applied to the PMT.
• GAIN Adjuster consists of voltage generator (DC+10V), three (3) variable resistors VR1,VR2,VR3
and three (3) jumper sockets J1, J2, J3 that are changeable.

LED Description
Table 5.4-15
LED Supplied
Purpose Remarks
No. Voltage
LED1 +12 V Confirmation of HV ON/OFF

The parts mounting diagram for the PMT-SHV2 board is shown below.
Figure 5.4-44
5.4.15.4 Adjustment of PMT-SHV2 Board

• Refer to Chapter 2.3.8 concerning calculation of control voltage.
• Control Voltage (CV) between TP2 (VCON-IN) and TP1(GND) is to be adjusted instead of the high
voltage by turning the necessary variable resistor and setting a jumper socket according to the
calculated Control Voltage (CV) relative to the high voltage as shown in the following table.
Table 5.4-16
High Voltage Output JP1 Setting / Variable Resistor Control Voltage (CV)
1 1100 (V) to 940 (V) JP1 / VR1 6.45 (V) to 5.13 (V)
2 1020 (V) to 810 (V) JP2 / VR2 5.57 (V) to 4.43 (V)
3 850 (V) to 660 (V) JP3 / VR3 4.66 (V) to 3.29 (V)
5.4.16 L-AMP(3) Board

Luminescence from the cell is converted to current signal by the PMT. Then, the current signal is
converted by the logarithmic function on this board and is sent to the EECL300 board.
Block Diagram
See the figure below.
5.4.16.2 Location
See Chapter 5.1.2.


The output voltage of the L-AMP (3) board is calculated as follows.
Figure 5.4-45

The parts mounting diagram for the L-AMP(3) board is shown below.
Figure 5.4-46

CAUTION
Be careful not to touch the variable resistors on the
board.
• L-AMP(3) board is preadjusted in production.
Any changes made in the field by the service
engineer will have a significant effect on
measured data. The warranty is no longer
valid in this case
5.4.17 LLD-SA Board

This board has the function of detecting and amplifying the liquid surface signal from the sipper and
sending it to the EECL300 board.
Block Diagram
Figure 5.4-47
5.4.17.2 Location
See Chapter 5.1.2.

• Variation of static capacity between sipper and system reagent unit is converted to unbalance the
signal of the bridge circuit, then amplified and sent to the EECL300 board.
• Refer to Chapter 5.3.2 Principle of Liquid Level Detection for details.

The parts mounting diagram for the LLD-SA board is shown below.

Figure 5.4-48

Sipper LLD Voltage Output (refer to Chapter 5.3.4.2)
5.4.18 LLD-P3 Board

This PCB has the function of detecting and amplifying the liquid surface signal from the pipetter and
sending it to the EECL300 board.
Block Diagram
Figure 5.4-49
5.4.18.2 Location
See Chapter 5.1.2.

• Variation of pipetter’s static capacity is converted to unbalance the signal of the bridge circuit, then
amplified and sent to the EECL300 PCB via DIST-PA PCB.
• Refer to Chapter 5.3.2 Principle of Liquid Level Detection.


The parts mounting diagram for the LLD-P3 board is shown below.
Figure 5.4-50

Pipetter LLD Voltage Output (refer to Chapter 5.3.4.1)
5.4.19 UIRS-C Board

This is a connection board between ECPU550, EECL300 board, and it also connects RS232
communication for BCR and host.
Block Diagram
Figure 5.4-51

Note: This block Diagram is Disk System

Note: Note for EIO3 PCB
∗ Disk System : EIO3 + DIST232C PCB
∗ Rack System : EIO3 + RSCONTD PCB
5.4.19.2 Location
See Chapter 5.1.2.

The parts mounting diagram for the UIRS-C board is shown below.
Figure 5.4-52
5.4.20 MVLB110 Board

This is the mother board for the following PCBs.

Block Diagram
Figure 5.4-53
5.4.20.2 Location
This board is located under the PCB rack.

The parts mounting diagram for the MVLB110 board is shown below.
Figure 5.4-54
5.4.21 S.AB-CE Board

This is a surge absorber circuit board.
Block Diagram
Figure 5.4-55
5.4.21.2 Location
See Chapter 5.1.2.


The parts mounting diagram of the S.AB-CE board is shown below.
Figure 5.4-56
5.4.22 DET-A Board

5.4.22.1 Overview
Figure 5.4-57
Block Diagram
Figure 5.4-58
5.4.22.2 Location
See Chapter 5.1.2.
5.4.22.3 PCP Description

See Chapter 5.6 for details.

5.4.23 DET-B Board

5.4.23.1 Overview
Figure 5.4-59
Block Diagram
Figure 5.4-60
5.4.23.2 Location
See Chapter 5.1.2.

5.4.24 DET-C Board

5.4.24.1 Overview
Figure 5.4-61
5.4.24.2 Location
See Chapter 5.1.2.


5.4.25 DETECT1 Board

5.4.25.1 Overview
Figure 5.4-62
5.4.25.2 Location
See Chapter 5.1.2.

5.4.26 RS CONTD Doard

Five (5) motor controllers GPCNT, a DI/DO buffer controller and serial transmit/receive signal controller
are located on this board.
Block Diagram
Figure 5.4-63
5.4.26.2 Location
See Chapter 5.1.2.

5.4.26.3 Function Description
Motor Controller
When a drive pattern of the motor and the command for the number of pulses are received from the
CPU, the GPCNT will output a magnetization signal and a pulse and transmits to the PS CONTA board.
The GPCNT sends the number of pulses that were ordered or stops the motor if it receives a
photo-interrupter signal.
DI/DO Buffer Controller

1. DI
Status information such as power supply surveillance, fuse detection, rack detection, cup detection and
tray full detection are received from the PS CONTA board.By READING each DI address, the CPU
knows the status of the above-mentioned items.
2. DO
The CPU will WRITE the ON/OFF condition of the +24 V power supply, the tray exchange indicator, the
cup detection timing, etc., into each address. This is then WRITTEN into each latch within the RS
CONTD board and transmitted to the PS CONTA board.
3. Serial Transmit/Receive Signal Controller
Executes the transmit/receive signal between the device itself and the rack unit with 16bit serial data.
Executes the parallel serial data exchange and the serial parity data exchange such as motor control
signal and DI/DO signal.
Location of DIP SW
Figure 5.4-64
DIP SW Description (DSW1)
Figure 5.4-65
Table 5.4-17
bit 1 bit 2 bit 3 bit 4 RS CONTD Board address
ON OFF OFF ON $D06000 to $D06FFF
ON OFF OFF OFF $D07000 to $D07FFF
DSW OFF ON ON ON $D08000 to $D08FFF (Initialize)
1 OFF ON ON OFF $D09000 to $D09FFF
OFF ON OFF ON $D0A000 to $D0AFFF
OFF ON OFF OFF $D0B000 to $D0BFFF
others not used


The parts mounting diagram for the RS CONTD board is shown below.
Figure 5.4-66
5.4.27 PS CONTA Board

Loaded on this board are a serial transmit/receive signal controller and a serial communication
command circuit with the RS CONTD board.

Block Diagram
Figure 5.4-67
5.4.27.2 Location
See Chapter 5.1.2.
Serial Transmit/Receive Signal Controller

Executes the transmit/receive signal between the device itself and the rack unit with 16bit serial
data.Executes the parallel → serial data exchange and the serial → parity data exchange such as
motor control signal and DI/DO signal.
Serial Communication Command Circuit

Commands the CLK signal of the serial communication; if a malfunction occurs within the
communication, an ERR occurs in the RS CONTD board.


The parts mounting diagram for the PS CONTA board is shown below.
Figure 5.4-68
5.4.28 DO4A Board

This board loads the constant-current drive motor driver of the stepping motor, then supplies the
current to the motor.
It also performs the waveform shape of the sensor, the ON/OFF fuse disconnect detection of the
DC+24V power supply and the voltage command.

Block Diagram
Figure 5.4-69
5.4.28.2 Location
See Chapter 5.1.2.
Stepping Motor Drive

Using the drive waveform from the GPCNT of the RS CONTD board, supplies the current that drives
the motors.
Table 5.4-18
Function
CH-No. Drive method Motor
(Sampler)
1 Constant Current SM200 A-Line
1-2 phase
2 Constant Current SM220 C-Line
1-2 phase
3 Constant Current SM210 B-Line
1-2 phase
Sensor Waveform Shape

Signal waveform (e.g. from photo-interrupters) is shaped in the TTL level and sent to the RS CONTD
board. The main element is MDI-R1 to 3.
DC+24V Power Supply ON/OFF

Buffers the ON & OFF signal from the RS CONTD board and turns the DC+24V power supply ON &
OFF. The main element is MP4501 (transistor array)
Fuse Disconnect Detection and Voltage Command

Detects disconnected fuses within the DO4A board and sends a detection signal to the RS CONTD
board. Also, if the DC+24V voltage within the DO4A board is low, it sends a detection signal of the low
voltage condition to the RS CONTD board.

Fuse/LED Description
Table 5.4-19
Fuse Rated Rated LED Supplied
Purpose Remarks
No. current voltage No. voltage
F1 3.2 A 48 V LED6 5V Logic drive use power supply
within the board
F2 ditto ditto LED1 24 V1 Power supply for the stepping CH-1,2
motor drive (1)
F3 ditto ditto LED2 24 V2 Power supply for the stepping CH-3
motor drive (2)
LED7 5 V1 Power supply for the latter part of
the photo-coupler
DIP SW Description
Table 5.4-20
JP1

JP2

The parts mounting diagram for the DO4A board is shown below.
Figure 5.4-72
5.4.29 BCR Board

This is the BCR board which connects the RS232C signal between the UIRS-C board and the BCR for
Rack System.

Block Diagram
Figure 5.4-73
Note: This block Diagram is Rack System
5.4.29.2 Location
See Chapter 5.1.2.

The parts mounting diagram for the BCR board is shown below.
Figure 5.4-74
5.4.30 PH-D Board
5.4.31 PH-T Board

Location
See Chapter 5.1.2.
Parts Mounting Diagrams

The parts mounting diagrams for the PH-D and PH-T boards are shown below.
Figure 5.4-75

5.5 Cross Wiring Diagrams

See pdf\SM5_5_Wire_Analyzer1_1.pdf for more details
See pdf\SM5_5_Wire_Analyzer1_2.pdf for more details
5.5.1 Cross Wiring Diagrams for Rack Sampler System

See pdf\5.5_RackSamplerSystem.pdf for more details
5.5.2 Cross Wiring Diagrams for Rack Sampler

See pdf\5.5_RackSampler.pdf for more details

5.6 How to Check Photo Interrupters
5.6.1 Photo Interrupters

The following Photo Interrupters (hereafter referred to as PCPs or PCP) are mounted in e411. See sketch
in Figure 5.6-1.
Table 5.6-1
No
PCP Name Appearance Position in e411
.
1. GP1A34LC PCP with a connector All the other positions described in the rows below
2. OJ-HT04 Smallish PCP with a circuit board Home position for syringes
3. OJ-HT02 Largish PCP with a circuit board Solid waste container present/absent detection
4. TLP830 Small PCP On FPC for pipetter/gripper home (HP), end (EP)
and rest(RP) position for gripper Y movement
5. TWIN-DETECT PCP attached to a plastic base On buffer station for tip present/absent detection
PLI-523
6. PM2-LF10HH Reflection PCP Rack tray and rack detection for A line, B line, C line
(for R/S)
7. PH-D and PH-T Through PCP Sampling position for B line unit
boards
(for R/S)

Figure 5.6-1

5.6.2 How to check the PCPs

Voltage and current at the PCP terminals are to be checked according to the following instructions.
Table 5.6-2
N
PCP
o How to check the voltage and the current Light path Voltage
Name
.
1 GP1A34 Close: Reflection is interrupted ca. 5 V
. LC • Check the voltage at Pin#3(Sig.) against Pin#2(GND).
Open: Reflection is ca. 0 V
uninterrupted
• Your voltage multimeter should show the right voltage
2 OJ- Close: Light path is interrupted ca. 0 V

. HT04 • Check the voltage at Pin#1(Sig.) against Pin#3(R.GND).
Open: Light shines across the ca. 5 V
gap
• Your voltage multimeter should show the right voltage if
the PCP is functioning properly.
Be careful not to short-circuit Pin#2(5V) and Pin#3(R.GND).

This PCP breaks readily in the event of a short circuit.
3 OJ- Close: Light path is interrupted ca. 0 V
. HT02 • Same as OJ-HT04. The only difference is the gap width.
Be careful not to short-circuit Pin#2(5V) and Pin#3(R.GND). gap
4 TLP830 Close: Light path is interrupted ca. 0 V
. • Check the voltage at Pin#4(Sig.) against Pin#2(R.GND).
gap
• Find a short-circuit on FPC when you try to find the Pin

location.
• Short-circuited on FPC are Pin#1(R.GND) and

Pin#3(5V).
• Check the voltage at the other two (2) Pins against Pin#1
or Pin#3 (5V) to find other Pin location.
Be careful not to short-circuit Pin#1 or #3(5V) and Pin#2

(R.GND). This PCP breaks readily in the event of a short
circuit.
5 PLI-523 Close: Light path is interrupted ca. 0 V
. • Check the voltage at Pin#5(Sig.1) against Pin#2 or by a tip
#3(R.GND) with and without a tip in Tip Pos. 1.
gap without a tip
• Check the voltage at Pin#6(Sig.2) against Pin#2 or
#3(R.GND) with and without a tip in Tip Pos. 2.


Table 5.6-3
N
PCP
o How to check the voltage and the current Light path Voltage
Name
.
6 PM2- Close: Light path is interrupted ca. 0 V
. LF10 • Check the voltage at Pin#2(Sig.) against Pin#3(GND).
gap
7 PH-D Close: Light path is interrupted ca. 0 V

. /PH- • Check the voltage at Pin#3(Sig) against Pin#1(5V).
Tboards gap
Be careful not to short-circuit Pin#1(5V) and Pin#3(Sig).


6.1 Overview
The service software is part of the system software that which provides you with tools with which you
can carry out programs for the instrument and measuring cell maintenance, check and adjust
mechanical units, monitor temperature, unit temperature and LLD voltage, etc. All functions with which
service engineers should be acquainted are described in the following chapter. Screens that are not
described in Chapter 6 are discussed in detail in the Software Guide of the Operator’s Manual.
Figure 6.1-1 System Overview Screen
If you started e 411 without the password protecting, the maintenance screen is as follows.
Figure 6.1-2 Utility-Maintenance Screen without the password protecting: Disk System

You cannot select “Service” item in this screen (only Maintenance and Check).
You should start the device in the service mode before service begins. It is according to the following
procedures.
1 ► Start e 411.
2 ► Push Operator ID button in system screen. Then following screen is shown.
Figure 6.1-3 Input Operator ID Screen
3 ► Input the following information and push OK button, then following screen is shown.
Operator ID: bmserv

Password: nakakojo

Figure 6.1-4 Pasword Protection Setting Screen
4 ► Push On button and OK button, then Logon screen is shown.
Figure 6.1-5 Logon Screen
5 ► Input the following information and push Logon button, then Overview screen is shown.
Operator ID: bmserv

Password: nakakojo
6 ► Open Maintenance screen. You can select “Service” item in Maintenance screen.

Figure 6.1-6 Utility-Maintenance Screen with the password protecting: Disk System
6.1.1 Utility Screen of Print
6.1.1.1 Alarm Trace

Output the alarm Trace from e411 and delete the Alarm information.
In case of output the alarm Trace

• Utility Screen - Alarm Trace “Daily” – Alarm Information “Print” – Data Selection “All” or “Data
Range” (Input the Start and End) – Press the “OK” button
• Utility Screen - Alarm Trace “Cumulative” – Alarm Information “Print” – Data Selection “All” or
“Data Range” (Input the Start and End date) - Press the “OK” button
In case of delete the alarm Trace

• Utility Screen - Alarm Trace “Daily” – Alarm Information “Delete” - Press the “OK” button
• Utility Screen - Alarm Trace “Cumulative” – Alarm Information “Delete” - Press the “OK” button

Figure 6.1-7 Print-Alarm Trace screen (Daily)
Figure 6.1-8 Print-Alarm Trace screen（Comulative）

Figure 6.1-9 Daily Alarm Trace
Figure 6.1-10 Comulative Alarm Trace
6.1.1.2 Communication Trace

Output the Communication tarce between e411 and Host system and delet the Communication Trace.
In case of output the Communication Trace

• Utility Screen - Communication Information “Print” – Press the “OK” button
In case of delete the Communication Trace

• Utility Screen – Communication Trace “Delete” - Press the “OK” button

Figure 6.1-11 Print- Communication Trace screen
Figure 6.1-12 Print- System Communication Trace
6.1.1.3 Operator ID Trace

Output the Operator ID information of Logon / Logoff.
• Utility Screen – Data Selection “All” or “Data Range” (Input the Start and End) – Press the “Print”
button

Figure 6.1-13 Print-Operator ID Trace screen（All）
Figure 6.1-14 Print-Operator ID Trace screen （Data Range）

Figure 6.1-15 Print- Oprator ID Trace
6.1.1.4 Application Parameters

Output the Application Parameters.
• Utility Screen – Press the “Print” button
Figure 6.1-16 Print-Application Parameters screen

Figure 6.1-17 Print-Application Parameters
6.1.2 Interface Setup
6.1.2.1 Start Conditions

Change the Host Setting “On“ or “Off“ of Host Communication.
In case of Host Communication “On”

• Start Conditions – Host Communication “On” – Press the OK button
Figure 6.1-18 Host Setting Screen

6.1.2.2 Host Communication Setting

Set the parameters of Host Communication.
Figure 6.1-19 Host Communication Setting Screen
Protocol Type
Elecsys / cobas : When selecting [Elecsys], it communicates with HOST by Elecsys type. When
selecting [cobas], it communicates with HOST by cobas type. You can select the baud rate only when
communication is OFF.
RS232C setting (Speed)
The baud rate choices are: 4800, 9600 and 19200.

You can select the baud rate only when communication is OFF.

Figure 6.1-20 Host Communication Setting Screen (Frame)
Character Configuration is selected from Table 6.1-1.

The setting is Changeable when “Host Communication” is off.
Table 6.1-1 Character Configurations

No. Data bit Parity bit Stop bit
1 7bit EVEN 2Stopbit
2 7bit ODD 2Stopbit
4 7bit ODD 1Stopbit
5 8bit NONE 2Stopbit
6 8bit NONE 1Stopbit
8 8bit ODD 1Stopbit
Automatic Result Upload
Yes/No : When [YES] is selected, result data of a sample is sent to HOST in real time as far as all
such data is collected.
Communication Trace
Yes/No : When [YES] is selected, communication detail with HOST is traced in e411
cobas Type Setting
When Protocol Type is [cobas], parameters are as follows.
Automatic Recovery of Session
Yes/No : This is an automatic reconnection function in case of communication is disconnected, (HOST

Communication Off) under error described ASTM1381-91 has occurred. When [Yes] is selected, the
erroneous message and a message sent from HOST before the reconnection process completed are
rejected.

Send Comment
Yes/No : When [Yes] is selected, enabled to register test selection information from HOST as well as
patients comment. It also enables to transfer to HOST the patient comment registered to the analyzer
along with result data. If not selected, the patient comment is not transferred.
QC Additional Information
ControlName/LotNo. : When [ControlName] is selected, name of control is sent as sample ID. When
[LotNo.] is selected, lot No. is sent as sample ID.
Send Result Only Mode
Yes/No : Only result data is sent. Inquiry for order is not conducted. This function is not applied to
Batch transfer.
HOST Test Code
Push “HOST Test Code” button, then following screen is shown.
Figure 6.1-21 Host Test Code Setting Screen (Frame)
You can set Test Code used by the communication(Host Code) besides it used instrument.Select Test
Code in list, input Host Code, then push OK button.
6.1.3 System Setup

The System Setup screen allows you to check the analyzer information, including the software version,
and set the current date and time (see Figure 6.1-22).

Figure 6.1-22 System Screen
Date and Time Setting
Date Format : “dd/mm/yyyy“ “mm/dd/yyyy“ “yyyy/dd/mm“ “yy/mm/dd“
Set Date / Time
Input the current date and Time.
Figure 6.1-23 Special Function Setting Screen

Serial No.
The serial number of the analyzer.
Install Date
The software installation date.
Software Version
The version of software currently loaded in the system.
Check Sum
Check Sum of AU and PC
Last LFC Date
Date of the last Liquid Flow Cleaning ( LFC ) procedure.
Total Test Counter
The total cumulative number of tests that have been performed on the analyzer. There is no user
access to this field. This number is not reset by reloading software.
Cell Test counter
This field tracks the number of assays performed on the measuring cell currently on the analyzer. This
number must be reset to “0” if a new measuring cell is installed.
Effective Signal Output
This function is to print out an Effective Signal[count] to the test result.
Test Generation Printout
This function is to print out an Test Generation to the test result.

Test Generation ON : TSH 0
Test Generation OFF: TSH
6.1.4 Storage Utility

The Storage Utility Setup screen allows to read some specific data and to write backup data from CF
or DVD.

Figure 6.1-24 Strage Utility Screen
6.1.4.1 In case of the Read System Specific Data from CD.

1 ► Connect the external media to a USB port on the left side of the analyzer.
2 ► Set CD that can be written.
3 ► Open the Storage Utility screen.
4 ► Select “Read System Specific Data” button.
5 ► Select “External” button.
6 ► Push “Execute” button, then read the system specific data from CD.
6.1.4.2 In case of the Back up Data from CF.

1 ► Open the Storage Utility screen.
2 ► Select “Back up Data” button.
3 ► Select “Internal” button.
4 ► Push “Execute” button, then write the backup data to CF.
Other function are as following.
Table 6.1-2 Strage Utility Functions

Read
No. Button name Data Note
/Write
1 Read System Specific Data Read All (including When the file for APC is changed, and when the file
APC data) for new APC is copied onto data F/D that you had
used up to now, uses this function.
1 ► Set data F/D with the file for new APC.
2 ► Push “Read System Specific Data”.
3 ► Set data F/D that has been used up to

now.
4 ► Push “Backup”.

Read
No. Button name Data Note
/Write
2 Read Reference Data Read Reference Reads refer.dat in which test item information etc.
data are defined and param.dat in which various
parameters(Common parameter that doesn't
depend on per-device) are defined.
3 Read Adjustment Data Read Adjustment Reads a peculiar adjustment value (adjust.dat) to
file the e 411 and parameter (analysis.dat) necessary
for the measurement.
When the reading processing is executed, it checks
Serial No. in data FD and Serial No. in the device. If
the check is OK, it executes reading. If NG, It
outputs the alarm.
4 Read Rack Adjustment Data Read Rack Reads only the adjustment value of line part peculiar
Adjustment adjust.dat to the e 411. No check the Serial No.
file When you ship only the “line part”, and the “line
part” is connected with the analysis part in the
locale, uses this function.
5 Back up Data Write All When the file for APC is read, the file for APC is
written. When is not read, the file for APC is not
written.
Back up Write(Internal)
Data files will be stored in d:\e411\backup\data_YYYYMMDD Max two folder. The older one will be
overwritten first. Files except APC files like SETUP00.dat, … , SEUP08.dat will be stored.
Back up Write (External)
Data files will be stored in e:\e411\data_YYYYMMDD (e: DVD-RAM drive)
Backup Read (Internal)
Folders in d:\e411\backup are shown.

Data files in d:\e411\data will be overwritten with the files in the selected folder.
Figure 6.1-25

Backup Read (External)
Folders in e:\e411 are shown.

Data files in d:\e411\data will be overwritten with the files in the selected folder.
Figure 6.1-26
Read (Internal)
Figure 6.1-27
Data files in d:\e411\data will be overwritten with the files in the selected folder
Read (External)
Data files in d:\e411\data will be overwritten with the files in the selected folder in the e:\
6.1.5 Documentation and Printer Setting

Set the external output method and information in this screen.

Figure 6.1-28 Documentation and Printer Setting
The meaning of a set each value is as follows.
6.1.5.1 Completion Conditions

You can define the external output method.
Table 6.1-3
Button Mean
Printout When the measurement result outputs it, the result is printed.
Upload When the measurement result outputs it, the result is uploading to HOST.
Printout/Upload When the measurement result outputs it, the result is printed and uploading to HOST.
6.1.5.2 Printer Condition

You can define whether to print.
Table 6.1-4
Button Mean
Connected Can print.
Not connected Even if the printer is connected, it is not printed.
6.1.5.3 Automatic Printout

"ON" means the function is selected. Otherwise not be selected. And you can select two or more.
Table 6.1-5
Button Mean
Calibration Sample The calibration result is automatically output.
Control Sample The control result is automatically output.
Stat Sample The Stat result is automatically output.
Routine Sample The routine result is automatically output.

6.1.6 Keep Function Setup

The Keep Function Setup screen allows you to choose different “Keep” functions – the sample type
and the default sample Cup.
Figure 6.1-29 Keep Function Setup
Keep Sample Type: You can decide to keep sample type or not.
Default Sample Cup: You can decide keep the default sample cup (Normal or Reduced).
6.1.7 Retry Function Setup

The Retry Function Setup screen allows you to choose “retry aliquot” functions – Sample Premature
LLD and Sample short.

Figure 6.1-30 Retry Function Setup
When Sample Premature LLD: When Sample Premature LLD occurs, you can decide to retry
aliquot(On) or not(Off).
When Sample short: When Sample short occurs, you can decide to retry aliquot(On) or not(Off).
6.1.8 Sample Reception Mode

The Sample Reception Function allows you to choose Sample Reception Mode. When you want to
begin analyzing at once, this function is effective.
Figure 6.1-31 Sample Reception Mode
Off: When the e 411 ends the analysis, it will change to Stand-by in 30 minutes.
1 – 12 Hours: When the e 411 ends the analysis, it will change to Stand-by in 1–12 hours.

6.2 Maintenance
How to select a maintenance function in the Maintenance screen
There are 10(Disk for 8 items) maintenance functions available. Each of them corresponds to a button
in the Check screen. Touch the Check button in the Maintenance screen in order to display the
Maintenance items. After touching a button in the Maintenance Items, a pop-up window appears in the
screen.
Figure 6.2-1 Maintenance screen for Rack System
Figure 6.2-2 Maintenance screen for Disk System

To start a maintenance function, touch the respective button.
The general functions of each button and the input area are as follows.
Start button : To start the maintenance function corresponding to the button
Close button : To close the pop-up window and return to the Maintenance screen without carrying
out any maintenance functions
Input area : To define how many times the maintenance function is to be carried out
There is no Stop button in the pop-up window. Instead, the Stop key can be used to stop the
maintenance function.
The following table shows a summary of the maintenance functions.
Table 6.2-1 Summary of the maintenance functions

No. Name Function
1. System Reset Resetting all the mechanical units and priming the pipetter system
2. Liquid Flow Cleaning A function that decontaminates the liquid flow system
3. L.And A. Reset All* Resetting all the mechanical units including Rack
Sampler
4. Rack Clear* Carrying all racks in the line to the output area (C line)
5. Sipper Pipetter Prime Priming the sipper system with system water
6. S/R Pipetter Prime Priming the pipetter system with system water
7. Measuring Cell Priming the sipper system three times and draining the measuring
Exchange cell.
8. Measuring Cell Conditioning the measuring cell
Preparation
9. Finalization Maintenance A function that carries out the finalization cycle
10. Media Write Output to external Media
Note: these maintenance functions are only available for rack systems
Initial conditions for the maintenance functions
When you start each maintenance function, make sure that the instrument is put in the condition
corresponding to the function described in Table 6.2-2.
Table 6.2-2 Initial conditions for the maintenance functions

No. Function Name Initial Condition
1. System Reset Water container contains at least 1L system water.
The water consumption is about 20 ml per cycle.
2. Liquid Flow Cleaning See 6.2.1.2
3. L.And A. Reset All Water container contains at least 1L system water.
The water consumption is about 20 ml per cycle
4. Rack Clear -
5. Sipper Pipetter Prime Water container contains at least 1L system water.
6. S/R Pipetter Prime Water container contains at least 1L system water.
7. Measuring Cell Water container contains at least 1L system water.
Exchange The water consumption is about 15 ml per cycle.
8. Measuring Cell 1)Water container contains at least 1L system water. The water
Preparation consumption is
150ml + n × 5 ml.
2)Mount PC and CC bottles in system reagent position 2. The
consumption of each system reagents is n × 2ml.
9. Finalization Maintenance See Chapter 6.2.1.9
10. Media Write External Media

6.2.1 Detailed Description of Each Maintenance Function
6.2.1.1 System Reset

System Reset is a maintenance function that resets all the mechanical units and primes the pipetter
system. This function is to be carried out when an operation is aborted due to an error and takes all
the mechanical units to their original positions. The reset function in the Service software is identical to
the reset that is carried out at the beginning of each run. Only Start and Close are available in the
System Reset pop-up window. About 20 ml water are needed each time System Reset is carried out.
6.2.1.2 Liquid Flow Cleaning

Contamination in the sipper system could potentially degrade sample accuracy and precision, or
possibly block the measuring cell flowpath. Liquid flow cleaning keeps the sipper liquid flowpath clean
and maintains the integrity of the measuring cell.
The customer should perform LFC on a frequent basis. Please train all your customers according to
the procedure described below and inform them about the importance of keeping the liquid flow path
clean and the measuring cell at the best performance level.
If operators perform this procedure frequently it will lead to fewer customer complaints.
Required materials: SysClean adapter Ident. No.: 1933159.910
ISE Cleaning Solution Ident. No.: 1298500
Recommended frequency *: Every two weeks or after 2500 - 3000 cycles
∗ If customer maintenance has been done as recommended, it is only necessary to carry out an additional customer
cleaning at the PM visit. The service LFC is only necessary during PM if the sipper line is highly contaminated or if
LFC has not been carried out regularly by the customer.
Operator time: Approx. 3 minutes
Analyzer time: User LFC: Approx. 16 minutes (user), Service LFC: Approx. 32
min + time for MC prepare cycles
Precautions: The cleaning solution is corrosive. Wear protective gloves and
glasses when handling this solution.
Procedure
1. User Replace the PC bottle in position 3 by the SysClean adapter (keep
the CC bottle in position).
Figure 6.2-3
Insert the adapter with the marking "USER" in direction towards the
back of the instrument. Fill the ISE cleaning solution to the edge of
the fill mark on the adapter (approx. 9 ml). PC/CC bottle has to be
placed at the left side.
2. Service Same procedure as for customers but using the Service position of
the adapter.
3. User Touch the Liquid Flow Cleaning button on the screen (Screen: Util /
/Service Maintenance).
4. User The number of LFCs should be 1 for User maintenance.

5. Service The number of LFCs should be 3 for service.

Take out the SysClean adapter and place ProCell and CleanCell
bottles in all positions.
Perform Measuring Cell Preparation cycles. [Press ”MC
Preparation” in Maintenance screen; select number of cycles]
• Start the LFC procedure shortly after filling up the ISE solution.
• After the instrument returns to Stand by remove the SysClean adapter and discard the remaining
ISE solution.
• To avoid an unpleasant odor, please empty the waste container at the end of the liquid flow
cleaning procedure.
• After a Service LFC has been performed customers should check all controls and carry out a
calibration if necessary. This is not necessary for normal routine with customer LFC.
When Liquid Flow Cleaning is completed the Liquid Flow system is set in the usual condition in which
the system is set when a run is completed in the normal manner. The function takes about quarter of
an hour.
6.2.1.3 L.And A. Reset All*

∗ *This function is available only for Rack Sampler.
L&A All Reset is a maintenance function that carries racks whose barcode has already been read to
the unloader, resets all the mechanical units and primes the pipetter system.
This function is to be carried out when an operation is aborted due to an error to take all the
mechanical units in the original position and the operation should be restarted from the condition
before the error occurred. The reset function in the Service software is identical to the reset which is
carried out at the beginning of each run.
About 20 ml water are needed to carry out the Reset function once.
6.2.1.4 Rack Clear*

∗ *This function is available only for Rack Sampler.
Rack Clear is a maintenance function that carries all racks in the line to the output line (C line). Only
Start and Close are available in the reset pop-up window.
6.2.1.5 Sipper Pipetter Prime

Sipper Pipetter Prime is a maintenance function that primes the sipper system with system water. This
function is to be carried out when the tubing in the sipper system is drained due for reason such as
replacing the tubing. However, this function should not be carried out unless it is followed by
measuring cell preparation. This is because the measuring cell is filled with water after the Sipper
Prime, and this might cause the luminescence signal to drift at the beginning of the following run. In
addition to Start and Close buttons in the pop-up window, the iteration number can be set in the input
area. The maximum iteration number is 100. It takes ca. 10 s to carry out the Sipper Prime function
once, and the process consumes ca. 5 ml water.
6.2.1.6 S/R Pipetter Prime

S/R Pipetter Prime is a maintenance function that primes the pipetter system with system water. This
function is to be carried out when the tubing in the pipetter system is drained for some reason such as
replacing the tubing, although the Pipetter Prime is always carried out when the system is reset or a
run is started. In addition to Start and Close buttons in the pop-up, the iteration number can be set in
the input area. The maximum iteration number is 100. It takes ca. 11 s to carry out the Pipetter Prime
function once, and the process consumes ca. 6 ml water.

6.2.1.7 Measuring Cell Exchange

Measuring Cell Exchange is a maintenance function that primes the sipper system three times and
drains the measuring cell. This ftunction is to be carried out before you replace or take out the
measuring cell mounted in the detection unit. Only Start and Close buttons are available in the pop-up
window. About 15 ml water are needed to carry out the Measuring Cell Exchange function once
6.2.1.8 Measuring Cell Preparation

Measuring Cell Preparation is a maintenance function that carries out preparation cycles in order to
condition a newly mounted measuring cell or measuring cells which have undergone maintenance
(refer to Installation and Maintenance). In addition, this function can be used just to initialize the sipper
system, especially just after the sipper prime to fill the MC with assay buffer. In addition to Start and
Close buttons in the pop-up window, the iteration number of the preparation cycles can be set in the
input area. The maximum iteration number is 100. Place ProCell and CleanCell bottles in system
reagent position 1 when you start this function. The consumption of water and system reagents to
carry out Measuring Cell Preparation are as follows:
Water: 150ml + iteration number × 5 ml

System reagents: iteration number × 2 ml
The following functions are to be carried out sequentially when Measuring Cell Preparation is started.
1. Reset
2. Priming the sipper system between the sipper syringe and the waste via SV4 (ca. 20 s)
3. Checking the system reagent inventory
4. Preparation 1 cycle (once without potential application)
5. Preparation 2 cycles according to the iteration number with the potential application
6. Preparation 3 cycle (once with the potential application)
7. Sipper finalization
When Measuring Cell Preparation is completed the sipper system is set in the usual condition in which
the system is set when a run is completed in the normal manner.
6.2.1.9 Finalization Maintenance

The Finalization Maintenance initiates the daily maintenance procedure of finalization maintenance.
Finalization is the analyzer status that occurs between the time when the analyzer stops pipetting
samples (S. Stop or R. Stop) and Stand-by. Finalization allows the analyzer to stand unused for
several hours (e.g. overnight). The system is primed with water, the measuring cell is filled with
ProCell and the sipper probe is cleaned with water.
The function takes about three (3) minutes.
6.2.1.10 Media Write

Output to external Media

6.3 Mechanism Check
How to select a mechanical unit check function in the Mechanism Check screen
There are 18(Disk for 18 items) mechanical unit check functions available. Each of them corresponds
to a button in the Check screen. Touch the Check button in the Maintenance screen in order to display
the Maintenance items. After touching a button in the Maintenance Items, a pop-up window appears in
the screen.
Figure 6.3-1 Mechanism Check screen for Rack System
Figure 6.3-2 Mechanism Check screen for Disk System

Some functions can also be activated by touching a button in one of the screens for the mechanical
unit adjustment.
There are some buttons in each pop-up window; some pop-up windows also have an input area.
The general functions of each button and the input area are as follows.
Start button : To start the maintenance function corresponding to the button
Close : To close the pop-up and return to the Maintenance screen without carrying out any
maintenance functions
Input area : To define how many times the maintenance function is to be carried out
There is no Stop button in the pop-up window. Instead, the Stop key can be used to stop the
maintenance function. While a mechanical unit check function is in process, the remaining iteration
number is displayed in the corresponding button. The number is reset to 1 when the Stop key is
pressed and to 0 when the function is completed.
The following table shows a summary of the mechanical unit check functions.
Table 6.3-1 Summary of the mechanical unit check functions

No. Name Function
1. System Volume Check System Volume Check is a maintenance function that measures the
system volume and updates the flag corresponding to the system
volume in the database.
2. Assay Performance Carries out following functions.
Check “Running Test”, “PMT High Volt. Adjustment” , “Artificial Media Test” ,
“TSH Assay Test” , “AM & TSH Test”
Please Refer 6.3.2.
3. Voltage Monitor LLD voltages of the S/R probe, the pressure sensor for clot detection
and the sipper probe. Voltages can only be checked while the analyzer
is in Stand-by.
4. Temperature Monitor Temperature, Target Temperature and Control parameters are
measured for Detection Unit and Incubator. Ambient temperature,
Temperature, Target Temperature and Control parameters are
measured for Reagent Disk and PC/CC (System reagent).
5. Sensor Monitor Select the sensor you want to check by touching the corrosponding
button. Check whether colour of the button changes when the sensor
detects.
6. Cap Open/Close Check Repeats the RackPack cap opening/closing from the RackPack in
position 1 counterclockwise as many times as entered in the input
area. The maximum repetition number is 180.
This function is also activated by touching the button in the screens for
the mechanical position adjustment.
7. Mixing Check Repeats the bead mixing from the RackPack in position 1
counterclockwise as many times as entered in the input area. The
maximum repetition number is 180.
This function is also activated by touching the button in the screen for
8. Magnet Up/Down Repeats the magnet drive upward and downward movement as many
times as entered in the input area. The maximum repetition number is
180.
9. Waste Tray Shaking Repeats the solid waste shaking as many minutes as entered in the
input area. The maximum repetition number is 180.
10. Sample BC Scanning Carries out S. Scan once including the database update and the
(for disk system only) transmission to HOST.

Table 6.3-2
No. Name Function
11. Bar Code Card Reading Carries out Barcode Card Scan once including the database update
and the transmission to HOST.
12. Reagent Pack BC Carries out R. Scan once including the database update and the
Scanning transmission to HOST.
13. Gripper Quick Check Carries out a mock operation with tips and vessels mounted on each
corner of each magazine. Only the gripper and the pipetter move
according to the AP 2, whereas the pipetter carries out only picking up
a tip and discarding it moving between the pipetter buffer and the
pipetter washing station.
This function is also activated by touching the buttons in the screen for
Figure 6.3-3
14. Gripper Repetition Check Carries out a mock operation with all full magazines. Only the gripper
moves according to the AP 2 although no tip/vessel discarding takes
place. Instead, all tips and vessels are to be returned back to their
original positions.
Figure 6.3-4

Table 6.3-3
No. Name Function
15. S/R Probe Check Carries out mock pipetter, reagent disk and cap opener cycles as
many times as entered in the input area with no liquid handling except
for the LLD. The maximum repetition number is 180.
The gripper carries a vessel to the vessel buffer (VB) at the beginning
of the function and discards it at the end.
Figure 6.3-5
16. Gripper S/R Probe Check Carries out mock cycles except for the sipper as many times as
entered in the input area with no liquid handling except for the LLD.
The maximum repetition number is 180.
This function is also activated by touching the button in the screens for
Figure 6.3-6

Table 6.3-4
No. Name Function
17. Sipper Check Carries out mock sipper cycles as many times as entered in the input
area. The current position is switched alternately every cycle. The
gripper carries a vessel to the sipping position at the beginning of the
function and discards it at the end. The maximum repetition number is
180.
Figure 6.3-7
18. S/R Probe LLD Check Checks the pipetter LLD function by moving the pipetter down to the
sample disk and the RackPack at position No. 1 of the sample disk
and the middle bottle at position No.1 of the reagent disk, respectively.
Figure 6.3-8
19. Sampler Check Carries out a mock operation with all racks on rack loader after reset
(only for Rack Sampler) action, checks the BC reading function on the rack sampler, and prints
out the result. Only the rack sampler moves in the same manner as in
the operation.
6.3.1 System Volume Check

System Volume Check is a maintenance function that measures the system volume and updates the
flag corresponding to the system volume in the database.
Only Start and Close buttons are available in the pop-up window.
The function must always be carried out when a part of the sipper line (sipper probe, tubing,
heat pipe or measuring cell) is replaced. Place ProCell and CleanCell bottles in system reagent
position 1 when you start this function. About 140 ml water and 5 ml assay buffer are needed to carry
out the System Volume Check function once. For further details refer to Chapter 3.2.2.
6.3.2 Assay Performance Check

Screen of the Assay Performance Check is shown below.

Figure 6.3-9 Assay Performance Check Screen
6.3.2.1 Running Test
Introduction
This test is carried out to check the mechanical movements of the system.
Materials Required
Table 6.3-5
RackPack name Amount Material No.
CellCheck 6 1820451-122
Samples Required: Disk
Table 6.3-6
Sample name Cups in Rotor Pos. Amount
ProCell 1-30 1 ml per test
Samples Required: Rack
Table 6.3-7
Cups in
Sample name No. of racks Amount
Pos.
ProCell 6 1-5 1 ml per test

1. Preparation
1 ► Place six (6) sets of RackPacks filled with CellCheck in positions 1 to 6 on the reagent disk.
2 ► Load thirty (30) Hitachi sample cups filled with ProCell on 6 racks for Rack System, or into
positions 1 to 30 on the sample disk for Disk System.
3 ► Make sure the liquid waste container is empty.
4 ► Fill the system water container with system water (max. 3.0 liters).
5 ► Place a CleanLiner in the solid waste tray.
Note: Reset the waster number counter mechanically by detaching the solid waste tray.
6 ► Place 2 (two) sets of system reagent ProCell/CleanCell bottles filled with ProCell/CleanCell
in the system reagent container.
7 ► Place three magazines filled with tips and three (3) magazines filled with assay cups on a
magazine tray.
8 ► Remove all tips and cups from the incubator and the buffer plate
2. Check Procedure
1 ► Make sure that the instrument is in standby status.

2 ► First perform Reset (Maintenance Screen)
Note: Make sure that no mechanical problem takes place by carrying out the “RESET” in reset
status.
3 ► Touch the Utility screen.

4 ► Touch the Check button in the screen
5 ► Touch the Assay Performance Check button.
6 ► Touch the Running Test button in the Assay Performance Check screen.
7 ► Having touched the button in the screen, you will see a popup shown below.
8 ► Start the Running Test by touching the Start button in the screen. 180 determinations
according to the Assay Protocol 2 are carried out on the instrument. This procedure lasts 2.5
hours.
3. Evaluation
1 ► At the beginning, check whether all mechanical positions (especially position relative to
pipetter, sipper, beads mixer) are sufficient within a tolerance limit; refer to Chapter 4.5
Mechanical Adjustment.
2 ► Observe the mechanical functions during the Running Test. Mechanical errors should not
take place.If you observe irregular movements, refer to Chapter 4.5 and carry out
Mechanical Adjustment.
3 ► Confirm that pipetter LLD functions properly.

Figure 6.3-10 Popup screen of Running Test
6.3.2.2 PMT High Voltage Adjustment

The PMT High Voltage Adjustment is already described in the installation part of the Service Manual.
Please Refer Chapter 2.3.11
6.3.2.3 Artificial Media Test (AM Test)

The AM Test is already described in the installation part of the Service Manual.
Please Refer Chapter 2.3.13.1
6.3.2.4 TSH Assay Test

The TSH Test is already described in the installation part of the Service Manual.
Please Refer Chapter 2.3.13.2
6.3.2.5 MC CO Check
Introduction
The MC CO (measuring cell carryover) Check is part of the AM Test and is carried out if only MC
carryover is to be checked. In the event of a general test of the system (e.g. when installing the
instrument, replacing the measuring cell or carrying out a performance check during maintenance)
both the complete AM test and the TSH assay test should be carried out.
The following measurements are carried out:
• 5 x BCR1 (homogeneous measurement)

• 5 x ProCell (heterogeneous measurement)
• 3 x iSAP (heterogeneous measurement)

• 3 x Carry Over (heterogeneous measurement)
The test takes about 30 minutes.
Materials Required
Table 6.3-8
Pos. No.
Name Beads R1 R2

2 - - - -
3 - - - -
5 SAP test iSAP Beads Buffer FC
Samples Required
Disk System
Place 1 ml ProCell in positions 2 to 8 and an empty Hitachi cup in Pos. 1.
Rack Sampler
Place 1 ml ProCell in positions 2 to 5 of a rack and an empty Hitachi cup in Pos. 1. In a second rack,
pipette 1 ml of ProCell in positions 1 to 3.
The further procedure is as described for the AM Test in Chapter 6.3.2.3.
6.3.2.6 LH Check
Introduction
The LH (liquid handling) Check is part of the AM Test and is carried out if only liquid handling is to be
checked. In the event of a general test of the system (e.g. when installing the instrument, replacing the
measuring cell or carrying out a performance check during maintenance) both the complete AM test
and the TSH assay test should be carried out.
The following measurement is carried out:
10 x BCR2 (homogeneous measurement)
The test takes about 18 minutes.
Materials Required
Table 6.3-9
Pos. No.
Name Beads R1 R2
1 - - - -
2 - - - -
4 - - - -
5 - - - -
Samples Required
Disk System
Place 1 ml BCR2 in Pos. 1.

Rack Sampler
Place 1 ml BCR2 in Pos. 1 of a rack.

The further procedure is as described for the AM Test in Chapter 6.3.2.3.
6.3.2.7 AM & TSH Test

Performed with pressing one button in APC screen. The Test takes about 45 min.
Preparartions

Set reagent rack packs in reagent disk positions 1 to 7 as follows
Table 6.3-10
Pos. No. Rack Pack Beads R1 R2
5 SAP test Beads Buffer FC
7 TSH Test Beads R1 R2
Sample arrangement
For Disk System:
Table 6.3-11
Run Cup in Rotor pos. Liquid
AM & TSH Test 3 BCR2 (1 ml)
4 to 10 ProCell (1 ml)
15 ProCell (1 ml)
16 TSH Cal 1
17 TSH Cal 2
Use Hitachi normal sample cups and RD calibrator vials.

Place a stop Bar code in Pos. 18.
For Rack Sampler :
Table 6.3-12
Rack in A line
Run Cup in rack pos. Liquid
No.
AM & TSH Test 1 1, 2 Empty cups
3 BCR2 (1 ml)
4, 5 ProCell (1 ml)
2 1 to 5 ProCell (1 ml)
3 1 ProCell (1 ml)
2 TSH Cal 1
3 TSH Cal 2
Use Hitachi normal sample cups and RD calibrator vials.


Start the test by pressing the AM & TSH Test in the APC screen.
Evaluation of the AM&TSH Test
For evaluation of the AM and TSH Test refer please chapter 2.3.13.1. and 2.3.13.3
6.3.2.8 Print Result

This function is to print out the results of the artificial media test, MC CO test, LH test and the TSH
assay test.
• Select the [Print Results] button in the [Assay Performance] check screen after you finish each
test of Assay the Performance Check.
• Having touched the button in the screen, you will see a popup .
• Touch the [print out] button on the popup if the instrument has APC results.
• Input “Date”, “Operator name”, “Instrument No.”, “BCR1 target value” and “BCR2 target value” on
the printed results sheet, and compare the results for each item with the criteria and evaluate
whether the results are acceptable or not.
Carry out “Print Results” after you finish each “AM test”, “TSH test”, “MC CO test”, “LH test”
of the Assay Performance Check, and before you touch the [Restore Parameter] button or start
any Assay Performance Check (APC).
Example for printout : AM Test
Figure 6.3-11

Example for printout : TSH Test
Figure 6.3-12

Carry out “RESTORE PARAMETER” after you have performed or even selected any Assay
Performance Check (APC).
Select the [Restore Parameter] button in the [Assay Performance] check screen if you have finished
the Assay performance section. You do not need to restore if you have performed another APC run.
When and what
• You must check the instrument according to the procedures in the following cases.
• The detailed checking procedures and acceptable ranges are described in the preceding sections.
• Some checking procedures are necessary as shown in the following table when some parts or
assemblies are replaced.
• The Running Test is to be performed if you make adjustments to the instrument to check the
reliability of the hardware.
Table 6.3-13 When and what has to be performed (see below for further details)
System
MC PMT-HV Initial Artificial TSH Assay
Case Volume
Prepare Check BlankCell Media Test Test
check
Instrument Installation X X X X X X
Detection Unit Replacement X X X X X X
Measuring Cell Replacement X - X X X X
PMT Replacement X X X X
ANG-EP Replacement
L-AMP Replacement
Magnet Drive Replacement - - - - X X
Sipper Probe Replacement - X - X - -
Sipper Tubing Replacement - X - X - -

System
MC PMT-HV Initial Artificial TSH Assay
Case Volume
Prepare Check BlankCell Media Test Test
check
Pipetter Probe Replacement - - - X X -
Pipetter Tubing Replacement - - - X X -
Long-term Rest
1. Installation of instrument . Refer to Chapter 2 for details.

2. Replacement of detection unit
3. Replacement of measuring cell
4. Replacement of PMT
5. Replacement of ANG-EP
6. Replacement of L-AMP
7. Replacement of magnet driver The same procedures to check instrument / MC performance as
recommended for installation: refer to Chapter 2.3.9 and following.
8. Replacement of sipper probe
9. Replacement of sipper tubing In case of changing a tube or any other part in the sipper flow path,
a system volume check must be performed. In addition, system performance should be checked
after exchange (AM, TSH assay test) in the same way as during PM exchange.
10. Replacement of pipetter probe
11. Replacement of pipetter tubing In case of changing any part in the pipetter liquid handling path, we
recommend checking liquid handling precision. At least the LH check (refer to Chapter 6.3.2.6)
should be performed (or, alternatively, the AM test).
12. Long-term rest Depending on the condition of the instrument, at least LFC and system
performance check should be performed.
Note: If the system appears to be contaminated we recommend performing the System Cleaning
function (refer to Maintenance) or exchanging the affected parts (tubings, etc.). For
instruments not used for more than 6 months, the 12 month PM procedure should also be
carried out (refer to Chapter 10).
General note
If any major performance shift is detected, assay calibration must be performed.
6.3.2.10 Assay Performance Check Troubleshooting

The Assay Performance Check Troubleshooting is already described in the installation part . Please
Refer Chapter 2.3.13.3
6.3.3 Voltage Monitor

Check the output voltages of the Pipetter LLD sensor, the Pressure sensor and the Sipper LLD sensor
on the Voltage Monitor Screen when the instrument is in Stand-by status according to the following
steps.
1 ► Touch the Voltage Monitor button in the Utility - Maintenance screen.

2 ► Touch the Voltage Button in which you want to see the voltage. If the instrument is not in
Stand-by status there will be no response.
3 ► If you want to see another voltage, touch the Monitoring Stop button followed by the Voltage
button. If you do not touch the Monitoring Stop button, touching other buttons is not possible.
4 ► If you want to switch to another screen, touch the Monitoring Stop button and the Close the
Voltage Monitor Screen.

Figure 6.3-13 Voltage Monitor screen
The following table shows the tolerance limits for each voltage and the Head Line Monitor.
Table 6.3-14 * Voltage Monitor function

Description Tolerance Limit Head Line Monitor
Pipetter LLD sensor 1.5 V or less when no Tip attached Pipetter LLD
to the Pipetter Probe Output Voltage
Pipetter Pressure sensor 1.80 ± 1.30 V after Pipetter priming and Clot Detection
leave for 2 minutes. Output Voltage
Sipper LLD sensor 3.5 V or less Sipper LLD
Output Voltage
∗ *For details, refer to Chapter 5.3.4
6.3.4 Temperature Monitor

You can see the Temperatures of the control points, the Ambient temperatures, the Target
temperatures, and the Control Parameter in the Temperature Monitor screen.
Figure 6.3-14 Temperature Monitor screen
For details refer to Chapter 5.3.1 and 5.3.6:

• Principle of temperature control

• Troubleshooting of temperature units
6.3.5 Sensor Monitor

This function is available for the Disk / Rack Sampler System.
6.3.5.1 How to select the Sensors Monitor function

• Touch the Sensors Monitor button in the Check screen.
• Select the Monitoring Start / Stop button. ( Toggle switch )
• Select the sensor you want to check by touching the corrosponding button.
• Check whether colour of the button changes when the sensor detects.
• Finish the Monitoring by pressing the Monitoring tart / Stop button.
Figure 6.3-15 Sensor Monitor screen for Disk
Table 6.3-15 Sensors corresponding to the buttons

Unit
Sensor No. Button name Remarks
R/S Pipetter PI055 Pipettor Abnormal Descend Crash Sensor

Tip Buffer PS051 Tip Buffer 1
PS051 Tip Buffer 2
Gripper PI068 Gripper Finger Grip Detection
S.Water Tank PI131 Distilled Water Lower Limit Float Switch
Liquid Waste PI133 Liquid Waste Container Level

Figure 6.3-16 Sensor Monitor screen for Rack Sampler System
Table 6.3-16 Sensors corresponding to the buttons

Unit Sensor No. Button name Remarks
A Line PI200 A Line Tray Tray Detection
PI201 Home Home Pos. Detection
PI202 Loading End Rack Feed End Pos. Detection
B Line PI210 B Line Home Home Pos. Detection
PI212 Rack Rack Detection
PI213 Stat STAT Pos. Detection
PI215 Sampling Sampling Pos. Detection
PI216 B.C.R BCR Read Pos. Detection
PI217 Cup Cup Detection
C Line PI221 C Line Home Home Pos. Detection
PI223 Rack Full Rack Full Detection
PI224 Tray Tray Detection
PI225 Tray Full 1 Tray Full 1 Detection
PI226 Tray Full 2 Tray Full 2 Detection
R/S Pipetter PI055 Pipettor Abnormal Descend Crash Sensor
Tip Buffer PS051 Tip Buffer 1
PS051 Tip Buffer 2
Gripper PI068 Gripper Finger Grip Detection
S.Water Tank PI131 System Water Lower Limit Float Switch
Liquid Waste PI133 Liquid Waste Container Level

6.4 Service
How to select a Service function
• After boot up the e411 or Logoff the e411, a pop-up window appears as shown in Figure 6.4-1.
• The Operation ID and Password are following.
Operator ID: bmserv

Password: nakakojo
• There are 15(Disk for 14 items) service functions available. Each of them corresponds to a button
in the Check screen. Touch the Check button in the Maintenance screen in order to display the
Maintenance items. After touching a button in the Maintenance Items, a pop-up window appears
in the screen.
Figure 6.4-1 Logon window

Figure 6.4-2 Service screen (for rack sampler)
Figure 6.4-3 Service screen (for disk)
6.4.1 Manual Adjustment

The three manual adjustment screens are shown below (Figure 6.4-4 to Figure 6.4-8). For details of
the adjustment (adjustment items, what is to be confirmed), refer to the table in Chapter 4.5.2
“Mechanical Adjustment”.

6.4.1.1 How to select a unit to be adjusted in the Manual Adjustment screens

Manual adjustment functions are available on three screens together with mechanical unit check
functions for some units. Each of them corresponds to a button in the manual adjustment screens.
Touch one of the manual adjustment buttons in the Service screen in order to display the screen. After
touching a button in one of the manual adjustment screens, a pop-up window appears in the screen.
Figure 6.4-4 Manual adjustment screen 1（for rack sampler）
Figure 6.4-5 Manual adjustment screen 1（for disk）

Figure 6.4-6 Manual Adjustment screen 2（for rack sampler）
Figure 6.4-7 Manual Adjustment screen 2（for disk）

Figure 6.4-8 Manual adjustment screen 3
In principle, the manual adjustment is carried out according to the following steps.
1 ► Touch a button corresponding to the unit and the position to be adjusted.

2 ► A pop-up window appears in which there are a maximum of most six buttons: OK, Cancel
and two or four buttons for the horizontal or vertical movement.
3 ► At the same time the unit moves to the position where the adjustment should take place.
4 ► Adjust the mechanical unit position by pressing buttons for the horizontal or vertical
movement.
5 ► After adjusting so that the gripper seems to stay in the best position, additionally move the
unit according to the offset value described in the Table in Chapter 4.5.1 for the positions for
which the offset values are defined (only some gripper positions).
6 ► Press the OK button when you are sure you have completed the adjustment successfully. If
not, press Cancel.
7 ► The pop-up window closes and the unit moves to the adjusted position when you touch the
OK button.
The adjustment parameters are updated when you close an adjustment by pressing the OK button.
This update is carried out even if an error takes place while the mechanical unit is moving after the OK
button has been touched. The adjustment parameters are displayed in the buttons in the three
screens for the adjustment.
By the time that the unit arrives at the position where the adjustment takes place, touching the buttons
is no longer effective. If the initial movement or the movement triggered by touching one of the buttons
for the movement is suspended for some reason, e.g. an error, the pop-up window can only be closed
using the Cancel button.
Usually the database update takes place in both the RAM and CF.
6.4.2 Adjustment Rack
6.4.2.1 How to select a unit to be adjusted in the Adjustment Rack screen

Touch the Adjustment Rack button in the Service screen to display the screen. After touching a button
in the Adjustment Rack screen, a pop-up window appears in the screen.
In principle, the Adjustment Rack is carried out in the same manner as described in Chapter 6.4.1. For
details of the adjustment, refer to the Table in Chapter 4.5.3.

Figure 6.4-9 Adjustment Rack Sampler screen
The following table summarizes the Adjustment Rack.
Table 6.4-1 Summary of the Adjustment Rack

Unit Position Preparation Adjustment
A Line Loading Pos. Right + /Left -
1. Set a tray with a rack on the A line.
B Line Sampling Pos. Front - /Back +

1. If there is a rack on the line, remove it.
2. Set a rack with a tube in the position 1 of the rack at the

STAT position.
Unloading Front - /Back +

1. If there is a rack on the line, remove it.
Pos.
2. Set a rack with a tube in the position 1 of the rack at the
STAT position.
BCR Reading Automatic Adjustment

1. If there is a rack on the line, remove it
Pos.
2. Set a rack with five tubes with BC labels at the STAT
position.
Sample & Rack No Preperation required Manual Input

ID Position

Figure 6.4-10 Pop-up Screen for B Line Manual Input
6.4.3 BCR Setup
6.4.3.1 Initialization
The BCR Initialize function is to be carried out as follows when you replace the BCR.
• Touch the Service button in the Maintenance Screen (see Figure 6.4-2,Figure 6.4-3).
• After touching the button in the BCR Initialization, a pop-up window appears as in Figure 6.4-11.
• Touch the OK button to complete the BCR Initialize function.

Figure 6.4-11 Pop-up window for Initialize
Note: The FLASH memory in the BCR has a lifetime of up to 1000 storage times. Therefore, the
Initialize and Check Digit functions should not be carried out too often.
Note: The above items are stored into the FLASH memory of the BCR even if you switch the
instrument off.
6.4.3.2 Check Digit

Four Sample BCR decode functions are available.
Code39, Interleaved 2 of 5, and Codabar (NW-7) correspond to a button in the Check Digit screen.
Code128 is automatically available.
1 ► Touch the Check Digit button in the System Screen.

2 ► After touching the button in the System screen, a Check Digit pop-up window appears as
shown in Figure 6.4-12.
3 ► Select a Check Digit according to the Barcode label required by the customer by touching
the appropriate button.
4 ► Touch the Send button if OK.

Figure 6.4-12 Check Digit Popup screen
Note: The user is recommended to use a bar code label that contains a check digit in order to
ensure reliable bar code reading.
6.4.3.3 Rack-Id Read Digit

This function is not available for the disk version.
1 ► Touch the Rack Assignment button in the System screen as shown in Figure 6.4-13.
2 ► After touching the Rack Assignment button in the System screen, a Rack-Id Digit setup pop-
up window appears as shown in Figure 6.4-14.
3 ► Select a digit number for Rack-Id reading.
4 ► Touch the OK button after selecting the number.
Figure 6.4-13 Rack Assignment screen (for rack sampler)

Figure 6.4-14 Digit Pop-up window
6.4.4 Service Setup

There are three functions available for service activities as follows.
Figure 6.4-15 Special Function Setting screen
6.4.4.1 Total Test counter Reset

This function resets the Test Counter by touching the button.
After resetting the Test Counter, confirm the action in the Instrument Setup screen.

The counter should not normally be reset, since it allows the total number of cycles performed on the
instrument to be checked.
6.4.4.2 Cell Test counter Reset

This function resets the Measuring Cell Test Counter by touching the button. The cell test counter
should be reset if the measuring cell is exchanged.
After resetting the Measuring Cell Test Counter, confirm the action in the Instrument Setup screen.
6.4.4.3 Effective signal

This function prints out an Effective Signal [count] for the test result by touching the button when you
want to know the count for detailed service activities.
Note: This function should only be used for service activities. The number of total results to be
stored in the database is lower when this function is activated.
6.4.5 Service Maintenance
6.4.5.1 Instrument Information Printout

Instrument Information Printout is a maintenance function that provides several technical information
like System Volume, Last LFC Date, Test Counter, Cell Exchange Counter and Adjustment Values via
printout.
Refer the example on the next page.
Figure 6.4-16 Instrument Information Printout screen

Example for Printout of Instrument Information:
Figure 6.4-17

Figure 6.4-18 Instrument information(Print View)
6.4.6 Alarm Setting

This function is Rack system only.
If you need the alarm when Rack Supply is completed, set “ON”. Otherwise set “OFF”.
Figure 6.4-19 Alarm Setting screen

6.4.7 Initial Blank Cell
After the measuring cell has been prepared and it has been checked that the signal level is in the
expected signal range by means of the high voltage adjustment, the initial BlankCell calibration has to
be performed. The instruments are calibrated to give the same homogeneous signal level.
The initial BlankCell measurement is the first calibration done on the instrument before other assays
can be calibrated. Each measured signal will first be BlankCell-corrected (parameters a (intercept) and
b (slope)). The corresponding concentration is then read from the specific assay calibration. For
further details refer to Chapter 2.3.12.
1 ► Set to “ON” on BlankSet Option.
Figure 6.4-20 Initial Blank Cell Calibration screen
2 ► Start Reagent Scan (Reagent Screen )

3 ► After the scan the BLANK CELL is requested by the instrument.
4 ► Press the Start button.
5 ► After the Blank Cell procedure has finished, check the printout of the results carefully. The
quality criteria should look the same as in the specimen printout. See attached printout of
successful Initial Blank Cell (specimen).

Figure 6.4-21
6 ► It is very important that the Initial Blank Cell is successful. If not, repeat the process until it is
successful, otherwise all results may not be corrected properly. Refer to Chapter 2.3.12.3
for current result targets. (If necessary start procedure once more. Go back to point 3.)
7 ► If the Initial Blank Cell was successful, remove the BLANK CELL RackPack. This is very
important, otherwise the instrument will do the periodic blank cell automatically.
8 ► Start reagent scan.
6.4.7.2 Evaluation of Initial BlankCell

• Compare the mean value of the BCR1 (all values are on the printout) counts with the target. It
should be: BCR1 Target range 120 to 400 counts.
• Check the slope value from [Initial BlankCell] screen: BCR2 Slope should be 1.0 ± 0.05 (=
parameter (b)).
• If one of the targets is outside these limits refer to the recommendations given and repeat the
procedure until the targets are reached.
6.4.7.3 Further Explanation of the Results Printed Out
Headline messages and interpretations

two messages are possible:
• BlankCell calibration was generated.
This message means that the procedure was successful; all quality criteria were met. No need for
further action.
• BlankCell calibration can’t be generated.

This means that the procedure failed; one or more of the quality criteria failed. The detailed quality
messages and the data groups below have to be studied to determine the cause.
Quality messages and interpretations
Three messages are possible, each depending on the results of the quality checks with status ok / not
ok.
In case of Öok no further action is needed.
In case of any Önot ok the following interpretations are possible:
Missing values
This field displays six dashes representing the six single measurements of the procedure.
In case of problems the data are not complete. The instrument was not able to perform the six
measurements. If a number appears instead of a dash, there was a problem with this measurement,
and this may indicate a mechanical problem.Problems with missing values cause further messages as
achievement of targets and deviations of replicates Önot ok.
Deviation of replicate measurements
This field reads

Öok if the replicate measurements are within the replicate limits listed in the columns below.
Ö In case of any
Önot ok a new BlankCell request has to be set and a new initial BlankCell has to be performed :
Achievement of targets
This field reads

Ö ok if all values of the replicate measurements are within the corresponding ranges Lower and
Upper around the targets.
If the field reads
Ö not ok, it indicates abnormal signal levels.
It is possible that only one single measurement has failed. In this case the means seem to be
Öok but the achievement of targets and probably the deviation of replicates are
Önot ok.
Comparison to last valid BlankCell
This quality message was only designed for user´s periodical BlankCell.
Therefore, it is ignored in case of the Initial BlankCell.
Data groups and interpretations

mean The median (not mean) of the replicate measurements. The value is given in PMT
counts.
target The target value in PMT counts. The value is encoded on the BlankCell reagent
barcode.
lower The lower acceptable limit in PMT counts. The limit was formerly designed as the
limit for a working range for the user’s periodical BlankCell. For initial BlankCell it
detects only extreme problems (< 200 counts for BCR1 / - 7% for BCR2). A better
criterion for signal levels are parameters a and b in the screen (-79 for a, 0.93 for
b).
upper The upper acceptable limit in PMT counts. The limit was formerly designed as the
limit for a working range for the user’s periodical BlankCell. For initial BlankCell it
detects only extreme problems (> 400 counts for BCR1 / + 7% for BCR2). A better
criterion for signal levels are parameters a and b in the screen (79 for a, 1.07 for

b).
replicate The maximum acceptable deviation of replicates to their median in percent.
limit
Upper group shows data for measurements with BlankCell Reagent BCR1.
Lower group shows data for measurements with BlankCell Reagent BCR2.
Left column shows data for BlankCell measurements of last valid BlankCell procedure.
This column was only designed for the user’s periodical BlankCell.
Right column shows data for actual BlankCell measurements.
6.4.8 Automatic Adjustment

Gripper automatic adjustment is used to adjust the gripper instead of manual adjustment.
6.4.8.1 Functions of the automatic adjustment

This automatic adjustment has six functions. The following table shows the purpose of each
adjustment function and the adjustment area corresponding to each adjustment function. Figure 6.4-
22 shows how to mount tips and assay cups for automatic adjustment.
Table 6.4-2
N
Adjustment Function Purpose Adjustment Area
o.
1 Gripper To adjust all positions when adjustment has Magazine, Incubator, Buffer
All Positions never been performed.
Preparation
2 Gripper To adjust all positions when adjustment has Magazine, Incubator, Buffer
All Positions been performed.
3 Magazine To adjust positions on magazines. Magazine
Cup / Tip
4 Sipping – Inc To adjust positions on the incubator. Incubator
5 C / T Buffer To adjust positions on the buffer. Buffer plate
6 Gripper – Z To adjust the height direction. Magazine, Incubator, Buffer
The following table shows the adjustment positions in each adjustment area that are described in
Figure 6.4-22.
Table 6.4-3
No. Adjustment Area Adjustment Positions
1 Magazine TM1_12, TM12_29, CM1_1, CM29_1
2 Incubator Inc1_1, Inc4_1, Inc4_8, Sipping
3 Buffer Tip Pos.1, CB

Figure 6.4-22 How to mount tips and vessels for automatic adjustment
Note: Adjustment Tool for buffer area should be placed on buffer plate.
6.4.8.2 How to operate the automatic adjustment

Touch the Automatic Adjustment button in the Utility screen.

Figure 6.4-23 Automatic Adjustment screen
Touch the Gripper All Position button in the Automatic screen.
Figure 6.4-24 Pop-up screen of Gripper All Positions
3. Gripper All Positions Preparation
At first, all adjustment values are set to zero (0) internally and the Preparation movement is
performed. All areas are continuously adjusted.
Preparation is a movement to find roughly a position that can pick up Tips or Cups at each adjustment
position. Adjustment of all areas is performed in two (2) or three (3) cycles. Whether or not the third
cycle is performed is decided automatically on the basis of the results of the first and second cycles,
but height adjustment is performed in three cycles. Adjustment values in the memory and on the FD

are overwritten when each adjustment cycle is finished. The color Note: of the display windows for
adjustment value(s) depends on the adjustment situation.
4. Gripper All Positions
Adjustment of all areas is performed using the adjustment values in the memory. See Point (1) for
details of the adjustment process.
5. Magazine Cup / Tip
Adjustment of the magazine area is performed using the adjustment values in the memory. See Point
(1) for details of the adjustment process.
6. Sipping - Incubator
Adjustment of the incubator area is performed using the adjustment values in the memory. See Point
(1) for details of the adjustment process.
7. C / T Buffer
Adjustment of the buffer area is performed using the adjustment values in the memory. See Point (1)
for details of the adjustment process.
8. Gripper - Z
The height adjustment is performed in three cycles in the order of Sipping position and CB position.
Adjustment values in the memory and on the FD are overwritten when each adjustment cycle is
finished. The color Note: of the display windows for adjustment value(s) depends on the adjustment
situation.
9. Gripper Adjust Write Media
The function is to write down the gripper adjust data ( ADJSTLOG.TXT) onto a CF card.
10. Gripper Adjustment Printout
The function is to print out the gripper adjust data.
Note: The display window is green, yellow or red. Refer to Chapter 6.4.5.6 for details of the
meanings of the three colors.
6.4.8.3 Adjustment procedure

CAUTION
Do not execute System Reset when the adjustment tool
is on the buffer plate because the pipetter probe will be
damaged..
1 ► Place Tips and Cups as shown in Figure 6.4-22according to purpose.

2 ► Place the adjustment tool on the buffer plate as shown in Figure 6.4-22.
3 ► Touch the Automatic Adjustment button in the Util screen.
4 ► Touch one of the adjustment item buttons in the Automatic Adjustment screen.
5 ► If an alarm occurs during the adjustment, perform automatic adjustment again after
troubleshooting.
6 ► After finishing the automatic adjustment, repeat the procedure if the display windows for
adjustment value(s) is red. Refer to Chapter 6.4.8.2.
7 ► In order to confirm that the automatic adjustment has been completed successfully, perform
the gripper / S/R Probe check.

6.4.8.4 Display of Adjustment Values and the Displayed Colors
Display of Adjustment Values
Adjustment values are displayed in the display windows for adjustment value(s) in the manual
adjustment screen. These displayed adjustment values are calculated from the value(s) obtained from
adjustment position(s) as shown in the following table.
Table 6.4-4
The Display Windows of Adjustment Position
Adjustment Area
Adjustment Value Using for Calculation
Magazine TM Front X TM12_29(X) and CM29_1(X)
Y TM1_12(Y) and TM12_29(Y)
TM Back X TM1_12(X) and CM1_1(X)
CM Left Y CM1_1(Y) and CM29_1(Y)
Incubator Sipping X Inc4_1(X) and Inc4_8(X)
Y Inc4_8(Y)
Incubator Y Inc1_1(Y) and Inc4_1(Y)
Buffer Tip Pos.1 X TP1(X)
Y TP(Y)
CB Pos. X CB(X)
Y VB(Y)
Incubator Sipping Z Sipping(Z)
Buffer CB.Pos. Z CB(Z)
Meaning of the Displayed Colors
The color of the display window for adjustment value(s) changes depending on the situation of
adjustment. However, if the instrument is switched off and on, all display windows change to green.
The following table shows the meaning of the displayed colors.
Table 6.4-5
Displayed Color Description
Green Adjustment finished successfully.
Yellow Corresponds to alarm code 51_01_02.
The Gripper could pick up a Tip or Cup at the adjustment limit of the adjustment position(s)
that is (are) used to calculate the adjustment value. Therefore, there is the possibility that the
automatic adjustment was not finished successfully.
Red Corresponds to alarm code 51_01_01.
The Gripper could not pick up a Tip or Cup at the adjustment position(s) that is (are) used to
calculate the adjustment value on at least one occasion. Therefore, the automatic adjustment
failed.
Note: If the displayed color is red, the adjustment value does not change. However, if the
adjustment values for X and Y are displayed in the same display window, one of the
adjustment values may be overwritten because the adjustment values for X and Y are
calculated separately.
What to do for each color of the display window
The following table shows what is to be done for each color of the display window of adjustment
value(s).
Table 6.4-6
Displayed color What to do
Green > No need to adjust again because the automatic adjustment was finished successfully.
If any alarms occur during operation, check the cause of alarm, e.g. cups floating on the
incubator, or tips and cups leaning to the side on the magazine.
Yellow > Basically, no need to adjust again.

Displayed color What to do

If any alarms occur during operation, take the following measures.
1. If the area for which the display window of adjustment value(s) has changed to yellow and
the area in which alarm has happened are the same, perform automatic adjustment in the
same area or adjust manually.
2. If the area for which the display window of adjustment value(s) has changed to yellow and
the area in which alarm has happened are different, check the cause of the alarm, e.g.
cups floating on the incubator or tips and cups leaning to the side on the magazine.
Red > Readjustment is necessary because automatic adjustment failed.
1. After performing manual adjustment of the affected position roughly, carry out automatic
adjustment of the area.
2. After checking mechanical position etc., carry out automatic adjustment of the affected
area or adjust manually.
Check the Gripper X/Y Tip Pos. 1
• Attach a Tip between the gripper fingers.

• Touch the Gripper X/Y Tip Pos.1 button in the screen as shown in Figure 6.4-18.
• Having attached a Tip, adjust the position so that the Tip end remains at the center of the hole.
Carry out the Gripper S/R Probe Check
In order to confirm that the automatic adjustment has been completed successfully, carry out the
Gripper S/R Probe Check by touching the corresponding button.
• Load three (3) magazines filled with Tips and three (3) magazines filled with Cups.
• Mount the System Water Container fill with system water (max. 3.5 Liters).
• Make sure that the Waste Box Tray is mounted correctly. Carry out mechanical reset of the waste
number counter by detaching the Waste Box Tray.
• Make sure that the Liquid Waste Container is mounted correctly.
• System Reagent PC/CC bottles are not to be mounted.
NOTICE
If you ignore a Pipetter LLD function which means LLD functions, but no liquid handling functions
during the Gripper S/R Probe Check, the following need not be prepared. If an LLD error takes place
in normal condition.
• Thirty (30) Hitachi Sample Cups filled with tap water.
• Eighteen (18) RackPacks filled with tap water.
• Make sure that the instrument is in Stand-by status.

• Touch the RESET button in the Maintenance screen.
• Touch the Gripper S/R Probe Check button in the screen.
• After touching the button in the screen, a pop-up window appears.
• Input a number of repetitions up to 180 and touch the OK button.
• Press the START button.
• Then confirm the mechanical reliability of the gripper movement.

7.1 Alarm List

See pdf\SM7_1.pdf for more details

7.2 Data Alarm List

Table 7.2-1 e411 Data Alarm List
Host
Host No
Screen/ No
Data Alarm (cobas Level Description
Printer (E2010
mode).
mode).
Power Fail/Power Off Cancel Cancel 1 - 1 The test concerned was canceled by
power fail or power off.
E.STOP Cancel Cancel 2 - 2 The test concerned was canceled by
E.Stop.
STOP Cancel Cancel 3 - 3 Operation stopped by operator or the
test concerned was canceled by Stop.
P.STOP/A.STOP Cancel Cancel 4 - 4 The test concerned was canceled by
P.Stop.
S.STOP Cancel Cancel 5 - 4 Sampling stopped by operator or the test
concerned was canceled by S.Stop.
Recovery Cancel Cancel 6 - 5 Determination not performed.
Sample Short Samp.S 7 3 6 Sample short detected.
Assay Reagent Short Reag.S 8 4 6 Reagent short detected.
Diluent Short Reag.S 9 4 6 Diluent short detected.
Pretreatment Reagent Short Reag.S 10 4 6 Pretreatment reagent
short detected.
Abnormal Reagent Disk Reag.T 12 74 7 Temperature of reagent disk above
Temperature permitted range.
Abnormal Incubator Inc.T 13 75 7 Temperature of incubator is above
Abnormal Measuring Cell Cell.T 14 77 7 Temperature of measuring unit is out of
Abnormal System Reagent SysR.T 15 76 7 Temperature of System Reagent is
Temperature above permitted range.
System Reagent Short SysR.S 16 62 6 System Reagent short detected.
ADC abnormal ADC.E 17 1 6 ADC data is abnormal.
Calculation Error Calc.? 24 39 6 Calculation not possible.
Only “No Value” may be shown and
printed out .
No Calibration Data Cal.E 25 43 6 No calibration data, result calculation not
possible.
Previous Calibration Data Cal.E 26 43 8 The measured data were calculated by
using previous calibration data.
Assay Reagent Hovering Reag.H 31 69 6 Premature LLD R.disk :
Assay Reagent
Diluent Hovering Reag.H 32 69 6 Premature LLD R.disk :
Diluent
Pretreatment Hovering Reag.H 33 69 6 Premature LLD R.disk : Pretreatment
Assay Reagent Film Detected Reag.F 35 70 6 Film detected on assay reagent
surface.
Diluent Film Detected Reag.F 36 70 6 Film detected on diluent surface.

Table 7.2-2
Host
Host No
Screen/ No
Data Alarm (cobas Level Description
Printer (E2010
mode).
mode).
Pretreatment Film Detected Reag.F 37 70 6 Film detected on pretreatment
surface.
System Reagent Film Detected Reag.F 38 70 6 Film detected System Reagent
surface.
AB Level Range Over >AB 40 63 6 AB signal level is out of range during
“Pre-Operation” cycle.
( < 120 or > 400 counts )
AB Level Check Error AB.E 41 64 6 AB liquid level check failed during
“Pre-Operation” cycle.
Current Range Over >Curr 42 65 6 MC current out of range during “Pre-
Operation” cycle.
Current Range Check Error Curr.E 43 66 6 MC current check failed.
System Reagent Temperature SysR.U 44 120 6 System Reagent temperature is
Unstable unstable
Sample Clot Detected Samp.C 45 72 6 Clot detected when pipetter aspirates
sample.
Low Signal Sample CarOvr 46 71 6 Carryover from the previous sample
may have occurred.
Sample ID Error Cancel Cancel 47 121 6 Sample ID scanning was not
successful.
Below normal(expected)range L 48 41 6 Final concentration is below expected
range, less than lower limit.
Above normal(expected)range H 49 40 6 Final concentration is above expected
range,
more than upper limit.
Below measuring range <Test 50 27 6 Concentration (not including diluent
ratio) is below measured range, less
than lower limit.
Above measuring range >Test 51 26 6 Concentration (not including diluent
ratio) is above measured range, more
than upper limit.
Expired RackPack ReagEx 52 101 7 Result generated with expired reagent
pack.
No Sample Samp.S 53 3 6 No sample has been detected.
Sample LLD Inexecution SLLD.E 54 86 6 Before sample LLD is carried out, it
stops because tip of the pipetter probe
may dirty, etc.
Sample LLD Noise SLLD.N 55 87 6 Sample LLD error generated due to
detection of electrostatic discharge.
Current Range Over(Operation) >Curr 56 99 6 MC current range over range
during operation.
Instrument Factor A FacA 57 122 6 Instrument Factor A is set to 1
by the system
Signal level below limit <SigL 58 100 6 Signal level is below the limit.
Re-measurement is recommended
Calc Test Error ClcT.E 37 6 Data flag is attached if one or both of
two tests are flagged, no result.
Overflow Over.E 38 6 The result is mathematically over
flown.

7.3 Troubleshooting list
7.3.1 Reagent Disk
7.3.1.1 R. Disk Home Position Detection, R. Disk Stop Position Detection

Table 7.3-1
N
Check Item Remedy
o
1 Photocoupler connected correctly? Remove front cover assembly.
Remove R jacket assembly.
Check connections of each of the photocouplers below.
Home Pos. : PI021
Stop Pos. : PI022
Connect lead wire between photocoupler and connector if disconnected.
2 Detection plate damaged? Check detection plate of pulley.
Exchange pulley if detection plate of pulley is damaged.
3 Wire lead disconnected from the Refer to cross wiring reference.
connector? Check whether pin is disconnected from the connector.
Insert pin into the connector again if it is disconnected from the
connector.
4 +5V supply voltage supplied? Check that +5V is supplied by DC power supply.
Exchange DC power supply if it did not output +5V.
Check pin (#1 : +5V) on each of the photocouplers below.
Home Pos. : PI021
Stop Pos. : PI022
Exchange photocoupler if it does not output +5V.
5 Signal voltage output correct? Turn on power SW of instrument.
Disconnect J520 connector (for R. disk rotation) in the Stand-by
situation.
Rotate the R. disk by hand.
Check the signal voltage output of J521 connector below.
Home. Pos. : #3 pin (closed : ca. 5V, open : ca. 0V)
Stop Pos. : #6 pin (same as above)
Exchange photocoupler if it does not output signal voltage.
6 All cable leads connected correctly? Refer to cross wiring reference.
Connect the connector if it is disconnected.
7 Tension of timing belt loose? Refer to Chapter 4.4.2.
Check tension of timing belt.
Adjust tension of timing belt by moving the motor
R assembly again if the timing belt is loose.
8 Timing belt itself defective? Check whether the timing belt is defective.
Exchange the timing belt if defective.
9 Motor fixed properly? Check that the motor R assembly is fixed.
Fix motor R assembly by tightening the fixing screws if it is not properly
fixed.

7.3.1.2 R. Disk Cover Open/Close Detection

Table 7.3-2
N
Check Item Remedy
o
1 Reagent disk cover closed correctly? Check that the reagent disk cover is closed correctly.
Put Reagent Disk Cover correctly again when it was not good.
2 No catch for detection changed Check Sensor Lever changed the shape.
the shape? Exchange Sensor Lever when it could not detect by changed the shape.
3 Wire lead disconnected from Refer to cross wiring reference.
the connector? Check whether pin is disconnected from the connector.
connector.
Exchange the DC power supply if it does not output +5V .
5 Signal voltage output correct? Turn on power SW of instrument and then wait for Stand-by.
Check the signal voltage output of the J525 connector below.
#3 Pin (open : ca. 5V, closed : ca. 0V)
Exchange the micro SW assembly if it does not output signal voltage.
7.3.2 Cap Opener
7.3.2.1 Cap Opener F/B Home Position Detection, Cap Opener F/B Stop
Position Detection
Table 7.3-3
N
Check Item Remedy
o
1 Cap opener is touching something? Execute Cap Open / Close Mecha in Maintenance screen.
Check whether cap opener is touching anything.
Readjust cap opener if it touched something.
2 Photocoupler detached from plate? Remove rear cover.
Check whether the photocouplers below have become detached from
plate.
Home Pos. : PI031
Stop Pos. : PI032
Exchange photocoupler if it is detached from plate.
3 Wire lead disconnected from the connector? Refer to cross wiring reference.
Check whether pin is disconnected from the connector.
connector.
Exchange DC power supply if it did not output +5V .
Check pin (#1 : +5V) of each of the photocouplers below.
Home Pos. : PI031
Stop Pos.: PI032
Disconnect J530 connector (for cap opener F/B movement) in the
Stand-by situation.
Move cap opener back and forth by hand.
Check signal voltage output of J531 connector below.
Home Pos.: #3 pin (closed : ca. 5V, open : ca. 0V)

N
Check Item Remedy
o
Adjust tension of timing belt by moving the pulse motor
assembly again if the timing belt is loose.
9 Motor and pulley fixed properly? Check that the pulse motor assembly and mount are fixed.
Fix pulse motor assembly and mount by tightening the fixing screws if
they are not properly fixed.
7.3.2.2 Cap Opener Open / Close Home Position Detection

Table 7.3-4
N
Check Item Remedy
o
1 Photocoupler detached from plate? Remove rear cover.
Check whether the photocoupler below has become detached from
plate.
Home Pos. : PI033
connector.
Check pin (#1 : +5V) on the photocoupler below.
Home Pos. : PI033
Exchange the photocoupler if it does not output +5V.
Disconnect J530 connector (for cap opener O/C movement) in the
Stand-by situation.
Move the hook of the cap opener up and down by hand.
Check the signal voltage output of J531 connector below.
Home Pos. : #9 pin (closed : ca. 5V, open : ca. 0V)
PH264-C97 assembly again if the timing belt is loose.
7 Cam itself defective? Check whether pin and holder are defective.
Exchange if defective.
8 Motor fixed properly? Check that the pulse motor PH264-C97 assembly is fixed.
Fix the pulse motor assembly by tightening the fixing screws if it not
properly fixed.

7.3.3 Beads Mixer
7.3.3.1 Beads Mixer Arm Home Position Detection, Beads Mixer Arm Stop
Position Detection
Table 7.3-5
N
Check Item Remedy
o
1 Vessel or tip around photocoupler? Remove cover R.
Check whether there are vessels or tips around the beads mixer
mechanism and remove.
Home Pos. : PI041
Stop Pos. : PI042
3 Detection plate damaged? Check detection plate of pulley S for damage.
Insert pin into the connector again if pin is disconnected from the
connector.
Check Pin (#1 : +5V) of each of the photocouplers below.
Home Pos. : PI041
Stop Pos. : PI042
Disconnect J540 connector (for beads mixer arm rotation) in the Stand-
by situation.
Rotate the beads mixer arm by hand.
PX 244M-02A assembly again if the timing belt is loose.
1 Motor or pulley fixed properly? Check that the pulse motor PX 244M-02A assembly and pulley are
0 fixed.
Fix the pulse motor PX 244M-02A assembly and pulley S by tightening
the fixing screws if they are not properly fixed.
7.3.3.2 Beads Mixer Upper Dead Position Detection

Table 7.3-6
N
Check Item Remedy
o
1 Cap of RackPack defective? Check whether cap of RackPack closes by itself after opening it by hand.
Exchange cap of RackPack if closes by itself.

N
Check Item Remedy
o
2 Photocoupler detached down Remove front cover assembly.
from plate? Remove beads mixer mechanism from instrument.
Check whether photocoupler for upper dead position detection has become
detached from frame.
Upper Dead Pos. : PI043
Insert pin into the connector again if it is disconnected from the connector.
Exchange DC power supply when it did not output +5V .
Check Pin (#1 : +5V) on the photocoupler below.
Upper Dead Pos. : PI043
Disconnect J540 connector (for beads mixer arm rotation) in the Stand-by
situation. Rotate the beads mixer arm by hand.
Upper Dead Pos. : #9 pin (closed : ca. 5V , open : ca. 0V)
Adjust tension of timing belt by moving the motor Z assembly again if the
timing belt is loose.
8 Timing Belt itself defective? Check whether the timing belt is defective.
Exchange the timing belt if it is defective.
9 Motor fixed properly? Check that the pulse motor Z assembly is fixed.
Fix the motor Z assembly by tightening the fixing screws if it is not properly
fixed.
7.3.4 Barcode Reader Mechanism
7.3.4.1 BCR Home Position Detection

Table 7.3-7
N
Check Item Remedy
o
1 Photocoupler connected correctly? Remove table cover L.
Check connections of the photocoupler below.
Home Pos. : PI151
2 Detection plate damaged? Check detection plate of bracket for damage.
Exchange bracket if detection plate of bracket is damaged.
connector.
Check Pin (#1 : +5V) on the photocoupler below.
Home Pos. : PI151

N
Check Item Remedy
o
Disconnect J650 connector (for BCR rotation) in the
Stand-by situation.
Rotate the BCR mechanism by hand.
Home Pos. : #3 pin (closed : ca. 5V , open : ca. 0V)
7 Motor fixed properly? Check that the motor BCR assembly is fixed.
Fix the motor BCR assembly by tightening the fixing screws if it is not
properly fixed.
8 Gear defective? Check whether part of gear of bracket is defective.
Exchange bracket if defective.
7.3.5 Sample Disk Mechanism
7.3.5.1 S.Disk Home Position Detection / S.Disk Stop Position Detection

Table 7.3-8
N
Check Item Remedy
o
Remove sample jacket.
Home Pos. : PI021
Stop Pos. : PI022
2 Detection plate damaged? Check detection plate of pulley for damage.
connector.
Check pin (#1 : +5V) on each of the photocouplers below.
Home Pos. : PI011
Stop Pos. : PI012
Disconnect J510 connector (for S. disk rotation) in the
Stand-by situation. Rotate the S. disk by hand.
Adjust tension of timing belt by moving the motor
S assembly again if the timing belt is loose.
9 Motor fixed properly? Check that the motor S assembly is fixed.
Fix motor S assembly by tightening the fixing screws if it is not properly
fixed.

7.3.6 Pipetter Mechanism
7.3.6.1 Pipetter-X Home Position Detection, Pipetter-X End Position Detection

Table 7.3-9
N
Check Item Remedy
o
1 Photocoupler detached from plate? Check whether the photocouplers below have become detached from
plate.
Home Pos. : PI051
End Pos. : PI052
2 Detection plate damaged? Check detection plate of P. carrier for damage.
Exchange P. Carrier if its detection plate is damaged.
connector.
Home Pos. : PI051
End Pos. : PI052
Wait until instrument goes into Stand-by.
Move the pipetter mechanism X direction by hand.
Check signal voltage output of each connector on Dist-PA
Board below.
Home Pos. : #3 pin (closed : ca. 5V, open : ca. 0V) of J554 connector.
End Pos. : # 3 pin (same as above) of J555 connector.
Adjust tension of timing belt by moving the base again if the timing belt
is loose.
9 Motor and pulley fixed properly? Check that the motor X and X pulley assembly are fixed.
Fix motor X and X pulley assembly by tightening the fixing
screws if they were not properly fixed.
7.3.6.2 Pipetter Upper Dead Position Detection, Pipetter-Z Abnormal Descent

Detection
Table 7.3-10
N
Check Item Remedy
o
1 Photocoupler detached down from plate? Check whether the photocoupler below has become detached from
plate. Upper dead Pos. : PI054
2 Detection plate damaged? In case of pipetter upper dead position detection :
Check detection plate of P. arm base for damage.
Exchange P. arm base if its detection plate is damaged.
In case of pipetter Z abnormal descent detection :
Check detection plate of pipetter probe for damage.
Exchange pipetter probe if its detection plate is damaged.

N
Check Item Remedy
o
Insert pin into the connector again if it is disconnected from
the connector.
4 FPC cable scratched? Check whether FPC cable is scratched. Exchange FPC cable if
scratched. Refer to cross wiring reference.
Check that resistance between each pin on the FPC cable is ca.0 [Ω]
using a multimeter.
Exchange FPC cable if the resistance between each pin on the FPC
cable is more than a few hundred ohms.
Check +5V is output at the pin of each of the photocouplers below.
Upper dead Pos. : #1 pin of PI054
Pipetter Z abnormal descent : #1, #3 pin of PI055
In case of pipetter upper dead position detection :
Move pipetter mechanism in Z direction by hand.
In case of pipetter Z abnormal descent detection :
Move pipetter probe up by hand.
Check signal voltage output of J556 connector on Dist-PA board below.
Upper dead Pos. : #9 pin (closed : ca. 5V, open : ca. 0V)
Pipetter Z abnormal descent : #3 pin
(open : ca. 5V, closed : ca.0V).
7 All cable leads connected correctly? Refer to Cross Wiring Reference.
Connect the connector when it disconnected.
8 Tension of timing belt loose? Refer to Chapter 4.4.5. Check tension of timing belt.
Adjust tension of timing belt by moving pulse motor KH423
M2-052. again if the timing belt is loose.
1 Motor and pulley fixed properly? Check that the pulse motor and pulley P are fixed.
0 Fix pulse motor and pulley P by tightening the fixing screws if they were
not properly fixed.
7.3.7 Pipetter / Sipper Syringe
7.3.7.1 Pipetter Syringe Upper Dead Position Detection, Sipper Syringe Upper
Dead Position Detection
Table 7.3-11
N
Check Item Remedy
o
Check the connections of each of the photocouplers below.
Pipetter syringe upper dead Pos. : PI091
Sipper syringe upper dead Pos. : PI101
2 Detection plate damaged? Check detection plate of fixture for damage.
Exchange fixture if its detection plate is damaged.
the connector.

N
Check Item Remedy
o
Check pin (#2 : +5V) of the photocouplers below.
Pipetter syringe upper dead Pos. : PI091
Sipper syringe upper dead Pos. : PI101
Execute Pipetter Prime and Sipper Prime in Maintenance Screen.
Pipetter syringe upper dead Pos. : #3 pin
(closed : ca. 0V, open : ca. 5V)
Sipper syringe upper dead Pos : #6 pin (same as above).
Adjust tension of timing belt by moving pulse motor
PH265M33 assembly again if the timing belt is loose.
9 Motor and pulley fixed properly? Check that the pulse motor PH265M33 and pulley 2 are fixed.
Fix pulse motor and pulley 2 by tightening the fixing screws if they are
not properly fixed.
7.3.8.1 Gripper-X Home Position Detection

Table 7.3-12
N
Check Item Remedy
o
1 Carrier-Z is touching something? Move carrier-Z assembly in the X direction by hand.
Check whether carrier-Z touches anything.
Readjust carrier-Z if it touched something.
2 Detection plate damaged? Remove cover C.
Check detection plate of slider X for damaged.
Exchange slider X if its detection plate is damaged.
3 FPC cable scratched? Check whether FPC cable is scratched.
Exchange FPC cable if scratched.
Refer to cross wiring reference.
Check that resistance between each pin on the FPC cable is ca.0 [Ω] using
a multimeter.
Exchange FPC cable if the resistance between each pin on
the FPC cable is more than a few hundred ohms.
Check Pin (#1, #3 : +5V) of the photocoupler below.
Home Pos. : PI061
Remove cover Y and magazine tray.
Move carrier-Z in the X direction by hand.
6 Wire lead disconnected from Refer to the cross wiring reference.

N
Check Item Remedy
o
Adjust tension of timing belt by moving holder C again if the timing belt is
loose.
1 Motor and pulley fixed correctly? Check that the motor C assembly and pulley C are fixed.
0 Fix motor C assembly and pulley C by tightening the fixing screws if they
were not properly fixed.
7.3.8.2 Gripper-Y Home Position Detection, Gripper-Y End Position Detection,

Gripper-Y Rest Position Detection
Table 7.3-13
N
Check Item Remedy
o
1 Slider-Y is touching something? Move the gripper mechanism in the Y direction by hand.
Check whether slider Y touches the DET A board / DET B
board.
Readjust the DET A or DET B board if slider Y touched it.
Check whether slider Y touches cover Y.
Adjust cover Y if slider Y touched it.
2 Detection plate damaged? Remove cover Y.
Check detection plate of slider Y for damage.
Exchange slider Y if its detection plate is damaged.
Check pin (#1, #3 : +5V) of each of the
photocouplers below.
Home Pos. : PI063
End Pos. : PI 064
Rest Pos. : PI 065
Move the gripper mechanism in the X direction by hand.
Check signal voltage output of each connector on the Dist-TVA board
below.
Home Pos. : #3 pin of J563 connector
(closed : ca. 0V, open : ca. 5V).
End Pos #5 pin of J564 connector (same as above).
Rest Pos : #3 pin of J564 connector (same as above).
Exchange photocoupler if it does output signal voltage.
connector.
Adjust tension of timing belt by moving holder C again if the timing belt
is loose.
9 Motor and pulley fixed properly? Check that the motor C assembly and pulley C are fixed.
Fix motor C assembly and pulley C by tightening the fixing
if they are not properly fixed.

7.3.8.3 Gripper Solenoid Abnormal Descent Detection, Gripper Finger Grip

Detection
Table 7.3-14
N
Check Item Remedy
o
1 Fingers opened/closed correctly? Remove cover Z.
Check open/close movement of gripper finger by hand.
Exchange rotary solenoid 2ER45-33 assembly if the open/close movement
of gripper finger was not good.
2 Photocoupler located correctly? Check that the photocoupler (abnormal descent : PI067 Grip : PI068) is
located correctly.
Reposition the photocoupler if the location was not good.
3 Detection plate damaged? In case of abnormal descent detection :
Check the detection plate of arm S for damage.
Exchange arm S if damaged.
In case of grip detection :
Check detection plate of arm L for damage.
Exchange arm L if damaged.
Check pin (#1, #3 : +5V) of each of the photocouplers below :
Abnormal descent : PI067
Grip detection : PI068
Move gripper finger arm up by hand.
Make the gripper finger catch a vessel or tip.
Check signal voltage output of J566 connector of Dist-TVA board below.
Abnormal descent : #4 pin (closed : ca. 0V, open : ca. 5V).
Grip Detection : #3 pin (same as above).
6 Wire lead disconnected from Refer to the cross wiring reference.

Check that the resistance between each pin on the FPC cable is ca.0 [Ω]
using a multimeter.
Exchange the FPC cable if the resistance between each pin on the FPC
7.3.8.4 Gripper Upper Dead Position Detection

Table 7.3-15
N
Check Item Remedy
o
1 Photocoupler located correctly? Remove cover Z.
Check that the photocoupler (upper dead position : PI066) is located
correctly.
Reposition the photocoupler if the location was not good.
2 Movement of gripper assembly Turn off power SW of instrument.
is smooth? Check that the movement of the gripper assembly is smooth when
moved up and down by hand.
Check whether the gripper assembly touches something.
Move the part of touching the gripper assembly out of the way.

N
Check Item Remedy
o
3 Detection plate damaged? Check the shield plate for damage.
Exchange the shield plate if damaged.
Check pin (#1, #3 : +5V) of photocoupler below.
Abnormal descent : PI066
Move gripper finger arm up by hand.
Check signal voltage output of J565 connector of
Dist-TVA board below.
Upper dead position : #10 pin
connector.

Check that resistance between each pin on the FPC cable is
ca.0 [Ω] using a multimeter.
Exchange the FPC cable if the resistance between each
pin on the FPC cable is more than a few hundred ohms.
7.3.8.5 Adjustment of Gripper Mechanism

Table 7.3-16
N
Check Item Remedy
o
1 Gripper finger catches vessel or Check that gripper fingers are parallel with each other.
tip correctly? Adjust gripper fingers so that they are parallel with each other again.
2 Vessel left on incubator after running? Remove cover Z.
Check that gripper fingers are mounted vertically to the incubator.
Adjust gripper fingers so that they are vertical to the incubator if they
were not vertical.
Check that the incubator is mounted parallel to Magazine tray.
Adjust so that incubator is again parallel to magazine tray.
7.3.9 Solid Waste
7.3.9.1 Solid Waste Home Position Detection

Table 7.3-17
N
Check Item Remedy
o
1 Vessel or tip around the solid waste? Remove magazine tray.
Check whether there are vessels or tips around solid waste and remove.
Remove cover R.
Check the connections for each of the photocouplers below.
Home Pos. : PI141
Box detection : PI142

N
Check Item Remedy
o
connector.
Check pin (#1 : +5V) of each of the photocouplers below :
Home Pos. : PI141
Box detection : PI142
Disconnect J640 connector (for solid waste shaking) in Stand-by.
Move the solid waste container back and forth by hand.
Check signal voltage output of the J641 connector below.
Box detection : #4 pin (closed : ca. 0V, open : ca.5V)
7.3.10 Sipper Mechanism
7.3.10.1 Sipper-X Home Position Detection, Sipper-X End Position Detection

Table 7.3-18
N
Check Item Remedy
o
Home Pos. : PI081
End Pos. : PI082
2 Detection plate damaged? Check detection plate of shield plate for damage.
Exchange shield plate if its detection plate is damaged.
connector.
Home Pos. : PI081
End Pos. : PI082
Disconnect J585 connector (for sipper-X movement) in Stand-by.
Move sipper Z assembly in the X direction by hand.
Check signal voltage output of each connector on the Dist-SA board
below.
Home Pos. : #3 pin of J583 connector
End Pos. : #3 pin of J584 connector (same as above).

N
Check Item Remedy
o
Adjust tension of timing belt by moving holder MD again if the timing belt
is loose.
9 Motor and pulley fixed correctly? Check that the X motor S assembly and holder MD are fixed.
Fix X motor S assembly and holder MD by tightening the fixing screws if
they are not fixed.
7.3.10.2 Sipper Upper Dead Position Detection, Sipper-Z Abnormal Descent

Position Detection
Table 7.3-19
N
Check Item Remedy
o
1 Photocoupler detached from plate? Check whether photocoupler below has become detached from
plate.
Upper dead Pos. : PI083
2 Detection plate damaged? In case of sipper upper dead position detection :
Check detection plate of base for damage.
Exchange base if its detection plate is damaged.
In case of sipper-Z abnormal descent detection :
Check detection plate of sipper probe for damage.
Exchange sipper probe if its detection plate is damaged.
connector.
Refer to the cross wiring reference.
Check that the resistance between each pin on the FPC cable is
ca.0 [Ω] using a multi meter.
Exchange FPC cable if the resistance between each pin on the FPC
Check +5V is output at pin of each of the photocouplers below.
Upper dead Pos. : #1 pin of PI083.
Pipetter-Z abnormal descent : #1, #3 pin of PI084
In case of sipper upper dead position detection :
Move sipper-Z assembly in the Z direction by hand.
In case of sipper-Z abnormal descent detection :
Move sipper probe up by hand.
Check signal voltage output of J586 connector on
Dist-SA board below.
Upper dead Pos : #8 pin (closed : ca. 5V, open : ca. 0V)
Pipetter-Z abnormal descent : #3 pin
(open : ca. 5V, closed : ca. 0V).
8 Tension of timing belt loose? Refer to Chapter 4.4.7. Check tension of timing belt.
Adjust tension of timing belt by moving cord P587
assembly with motor again if the timing belt is loose.

N
Check Item Remedy
o
Exchange timing belt if it is defective.
1 Motor and pulley fixed properly? Check that cord P587 assembly with motor and pulley P are fixed.
0 Fix cord P587 assembly with motor and pulley P by tightening the
fixing screws if they are not properly fixed.
7.3.11 Magnet Drive Mechanism
7.3.11.1 Magnet Drive Home Position Detection

Table 7.3-20
N
Check Item Remedy
o
1 Photocoupler detached from plate? Check whether the photocoupler below has become detached from the
plate.
Home Pos. : PI111
2 Detection plate damaged? Check detection plate of magnet arm assembly for damage.
Exchange magnet arm assembly if its detection plate is damaged.
connector.
4 Magnet arm assembly touches a cable? Remove side cover, front cover.
Check whether the magnet arm assembly touches a cable.
Change the way the cable is bundled if the magnet arm assembly is
touching a cable.
Check +5V is output at pin of the photocoupler below.
Home Pos. : #1 pin of PI083.
Move the magnet arm assembly back and forth by hand.
Check the signal voltage output of the J601 connector below.
8 Motor functions correctly? Remove cover.
Execute Magnet Up/Down in the Mecha Check Screen.
Check that the magnet arm assembly moves correctly.
Remove the magnet drive assembly if it does not move correctly. Repair
or exchange the faulty part.
7.3.12 Pipetter Buffer

Table 7.3-21
N
Check Item Remedy
o
Twin detect : #2, #5 pin of J559 connector.
Exchange photocoupler PS051 if it does not output +5V.

N
Check Item Remedy
o
Insert tip into buffer position by hand.
Signal 1 : #6 pin (closed : ca. 0V, open : ca. 5V)
Signal 2 : #4 pin (same as above)
connector.
7.3.13 Distilled Water Float Switch

Table 7.3-22
N
Check Item Remedy
o
1 Wire lead disconnected from the connector? Remove rear cover and front cover assembly.
the connector.
Float SW : #1 pin of J630 connector.
Exchange float SW PI131 if it does not output +5V.
Float SW : #3 pin (closed : ca. 5V, open : ca. 0V)
Closed means water empty in buffer tank, Open means water in buffer
tank.
Exchange float SW if it does output signal voltage.
7.3.14 System Reagent Unit
7.3.14.1 PC / CC Bottle Detection

Table 7.3-23
N
Check Item Remedy
o
1 Does LED on the sensor light up? Remove cover.
Check whether the LED on the sensor lights up when
PC/CC bottle is put in the system reagent unit.
Exchange sensor assembly if the LED does not light up.
2 Wire lead disconnected from Remove rear cover and front cover assembly and
the connector? S.R cover.
connector.

N
Check Item Remedy
o
Exchange DC poser Supply if it did not output +5V.
Bottle 1 : #1 pin of J663 connector.
Bottle 2 : #4 pin of J663 connector.
Photocoupler outputs ca. +5V when there is PC/CC bottle in the system
reagent unit and ca. 0V when there is no bottle in the system reagent
unit.
Exchange the photosensor if it does not output +5V.
Wait until the instrument goes into Stand-by.
Place PC/CC bottle in the system reagent unit by hand.
Signal 1 : #3 pin (closed : ca. 0V, open : ca. 5V)
Signal 2 : #6 pin (same as above)
7.3.15 Liquid Waste Mechanism
7.3.15.1 Waste Tank Detection, Waste Tank Full Detection

Table 7.3-24
N
Check Item Remedy
o
1 No Waste Tank Container changed Check Waste Tank Container changed the shape.
the shape? Exchange Waste Tank Container when it changed
the shape.
2 No Detection Plate changed the shape? Check Detection Plate of Support and Plate changed the shape.
Exchange Support or Plate when it changed the shape.
3 Wire lead disconnected from Remove rear cover and front cover assembly.
the connector? Refer to cross wiring reference.
connector.
Exchange DC poser Supply if it did not output +5V .
Waste tank container : #1 pin of J631 connector.
Waste tank full : #4 pin of J631 connector.
Exchange photosensor if it does not output +5V.
Wait until the instrument goes into Stand-by.
Place a waste tank container in the liquid waste base
assembly by hand.
Place a waste tank container full of water in the liquid waste base
assembly.
Waste tank container : #3 pin (close : ca. 5V, open : ca. 0V)
Waste tank full : #6 pin (same as above)

7.3.16 Rack Sampler System
7.3.16.1 A - Line
Table 7.3-25
N
Check Item Remedy
o
1 Photocoupler connected correctly? Check the connections for each of the photocouplers below.
Tray detection : PI200
Home Pos. detection : PI201
Rack feed end Pos. detection : PI202
Exchange pulley if its detection plate is damaged.
connector.
Signal voltage output correct? Exchange DC power supply if it did not output +5V.
Confirm the function of each photocoupler by using the Monitoring
Sensors function in the Admin screen.
Exchange photocoupler if defective.
5 All cable leads connected correctly? Refer to Cross Wiring Reference.
Connect the connector when it disconnected.
6 Timing belt itself defective? Check whether timing belt A is defective.
Exchange timing belt A if defective.
7 Motor fixed properly? Check that the motor assembly is fixed properly.
Fix the motor assembly by tightening the fixing screws if it was not
properly fixed.
7.3.16.2 B - Line
Table 7.3-26
N
Check Item Remedy
o
Rack detection : PI212
STAT Pos. detection : PI213
Sampling Pos. detection : PI215
BCR read Pos. detection : PI216
Cup detection : PI217
connector.
Confirm the function of each photocoupler by using the
Monitoring Sensors function in the Admin screen.

N
Check Item Remedy
o
8 Timing belt itself defective? Check whether timing belt B is defective.
Exchange timing belt B if defective.
9 Motor fixed properly? Check that motor assembly is fixed.
properly fixed.
7.3.16.3 C - Line
Table 7.3-27
N
Check Item Remedy
o
Rack full detection : PI223
Tray detection : PI224
Tray full 1 detection : PI225
Tray full 2 detection : PI226
connector.
Confirm the function of each photocoupler by using the
Monitoring Sensors function in the Admin screen.
6 Timing belt itself defective? Check whether timing belt CG is defective.
Exchange timing belt CG if defective.
7 Motor fixed properly? Check that the motor assembly is properly fixed.
properly fixed.
7.3.17 CF card problem
7.3.17.1 Introduction:
There are two CF cards installed at User interface panel PC of e411 instrument. The CF of drive C: is
used for Embedded Windows XP OS and drivers. And the CF of drive D: is used for application
software and data. If the CF of drive C: is damaged, the Windows XP OS can not boot. In this case,
PC should be replace.
The target of this document is the CF of D drive in which the application software and data were
installed.
7.3.17.2 Crave up the reason of Alarm
Alarm code
When the alarm code of 41-01-01 to 41-01-10 and 57-01-01 are appeared, Please format D: drive and
reinstall the application soft following.
The procedure for format D: drive CF card will be shown below.
1 ► Logoff of e411 application

► Push Logoff button and display Logoff dialog screen, then push Shutdown button.
Figure 7.3-1

3 ► Close the cmd.exe when e411 system boot up
► Push close button on cmd.exe screen.
Figure 7.3-2
4 ► Touch [Start]-[Run] to show the run window and input “format d:” at “Run” windows.
► Please confirm that the data you need is backed up. Then touch “OK” button.
Figure 7.3-3

Figure 7.3-4
5 ► Enter the volume label for drive d: “toshiba512m” and enter “Y” key to process format. After
formatting the D: drive, Volume label input is requested. Input “toshiba512m” and enter
“Enter” key to finish the format process.
Figure 7.3-5
6 ► If the format can no be done, please replace CF and reinstall the D: drive.
If the same alarm still appeared, please replace the CF card. The procedure is shown below. If the
same alarm disappeared, please reinstall application software.
7.3.17.3 Replace the CF card

Before do this action, PC and instrument should be powered off.
1 ► The spare part number of CF card is “J789021”, part name is “Flash Card”.Default of this
card is formatted.
2 ► CF card slot is located at the left side of User Interface panel PC. Take out the + screw
show at following picture.

Figure 7.3-6
3 ► The D drive CF is inserted at bottom slot of CF slot. The picture is shown as following.
Figure 7.3-7
4 ► Please take an action to prevent electrostatic discharge before touch the CF card.
5 ► Push the Slot in/out button to remove damaged CF card and insert a new one.
6 ► Attach the slot cover by tighten the screw.
7.3.17.4 Reinstall the application software

Please reinstall the User Interface panel PC application software.

7.4 Quality Control Check
7.4.1 Covers
• check for lead wires is pinched
• check for photo couplers move out
• check for shift of positioning
7.4.2 Sample/Assay Reagent Rotation Mechanism

Sample Disk Rotor (after exchange);
• adjust the cup position on sample disk and pipetter nozzle

• adjust the sample disk rotor
• adjust the sample disk rotor belt tension
Assay Reagent Rotor (after exchange);
• adjust the rack pack position on reagent disk and pipetter nozzle
• adjust the reagent disk rotor belt tension
7.4.3 Cap Open/Close Mechanism

Forward/Backward Mechanism (after exchange);
• adjust the belt tension

• check for forward/backward movement
Cap Opener Mechanism (after exchange);
• check for hook shift of positioning

• check for cap opener movement
7.4.4 Beads Mixer Mechanism

Up/Down Mechanism (after exchange);
• adjust for height of mixing paddle

• check for up/down movement
• check for mixing paddle warp
Rotation Mechanism (after exchange);
• adjust for positioning of rack pack and mixing paddle

• check for rotating movement
Mixing Mechanism (after exchange)
• check for wrap of rubber belt

• check for mixing movement
• check for mixing paddle wrap
7.4.5 Barcode Reader Mechanism

Barcode Reader (after exchange);

• check for light of led

• check for reading label
• rotation Mechanism (after exchange);
• adjust for backlash at gear
• check for rotating movement
7.4.6 Pipetter, Sipper Mechanism

Pipetter Mechanism
• check for tube leakage

• adjust for each position
• check for abnormal movement
• check for X direction movement
• check for Z direction movement
Sipper Mechanism (after exchange);
• same as pipetter mechanism
7.4.7 Syringes Mechanism (after exchange);

• check for leakage
• check for up/down movement of plunger

X direction motor (after exchange);

• check for x direction movement
• adjust for belt tension
Y direction motor (after exchange);

• check for Y direction movement
Z direction motor (after exchange);

• adjust for Z direction movement
• check for obstacle detection
• Solenoid (after exchange);
• check for finger movement
7.4.9 solid Waste Mechanism

Motor (after exchange);
• check for shaking movement

7.4.10 Incubation Unit

• check for gap temperature of incubator
• check for concerning position with gripper
7.4.11 Detection Unit

Measuring Cell (after exchange);
• check for gap between Cell and Cell Base

PMT (after exchange);
• check for socket

• check for gap between PMT and Cell Base
Magnet Drive (after exchange);
• check for out of touch with lead wire

• adjust for position center of Cell
• check for up/down movement
7.4.12 Pump Module (after exchange);

• check for noise
• check for fixing certainly
• check for water volume
7.4.13 Solenoid Valves (after exchange);

• check for open/close movement (ON/OFF)
• check for fixing certainly
• check for tube connection
7.4.14 PCBs (after exchange);

• check for connectors insert certainly
• check for connectors insert position
• check for out of touch some objects
7.4.15 Control PC (after exchange);

• check for indication screen
• check for input touch key
• check for Alarm sound
• check for Printer
7.4.16 Check for the measuring data below Assay Performance Check
• PMT-HV Adjustment
• Artificial media test
• TSH Assay test

8.1 Special Service Tools

The following are necessary/recommended special tools for service activities.
Table 8.1-1
No. Name Part Number What purpose is Referred Chapter
1 Gripper Adjustment 741-8742 To be used for manual gripper adjustment Chapter 4.5.2
Tool(1) for Tip position attaching between the gripper Mechanical Adjustment
fingers. Procedure
2 Gripper Adjustment 741-8743 To be used for manual gripper adjustment for Cup Chapter 4.5.2
Tool(2) position attaching between the gripper fingers. Mechanical Adjustment
Procedure
3 Gripper Adjustment 741-8741 To be used for manual gripper adjustment for Chapter 4.5.2
Tool(3) Sipping / Incubator / Buffer position attaching Mechanical Adjustment
between the gripper fingers. Procedure
4 Gripper TABLE COVER 741-8813 To be used for manual gripper adjustment for Vessel Chapter 4.5.2
ADJUSTMENT TOOL Waste position attaching between the gripper Mechanical Adjustment
fingers. Procedure
5 Magnet Drive Tool 741-1627 To be used for adjusting a magnet position where Chapter 4.4.14.7
may be sufficient for Beads capturing.
Attach the tool into a Base in stead of a Measuring
Cell.
6 Tin Plate 0.8 741-1985 To be used for adjusting a tolerance limit where Chapter 5.3.4
Pipetter detects a crash.
7 Tin Plate 1.2 741-1986 According to Adjustment Procedure, check the crash Chapter 5.3.4
sensor signal output by measuring the voltage
between the connector pin#3 of J556 and TP2 AG
on DIST-PA Board.
8 Pin Extraction Tool 1 741-5916 To be used for detaching a wire from a connector for
instance, P591, P592, etc.
instance, J591, J592, etc.
instance, P16, J16 etc.
11 Pin Extraction Tool 4 J826845 To be used for detaching a wire from a connector for
instance, P13, P14, etc.
12 Long Driver N330013 To be used for dis- and re-assembling a mechanical
part.
13 PPM Meter 1903152 To be used for mixer speed adjustment. Chapter 2.6.1.1
14 Flange Kit 1802208 To be used for tubings.

8.2 Complete Parts List

Separate cobas e411 Parts List ( P/N 741 - 9100 ) available.

9.1 Host Interface

Separate cobas e411 Host Interface Manual available.

Safety Information
Refer to this section when you find Read Safety Information on the section title.
WARNING
Section 10.1 Maintenance
Procedure Overview
• Use the personal protective
equipment (such as rubber
gloves, lab coat, safety glasses,
etc.) recommended by your
facility when handling
biohazardous materials.
• Be sure to wear personal protective
equipment (such as rubber gloves,
lab coat, safety glasses, etc.) before
performing any maintenance/checks,
and follow the procedure described
in this operator’s manual.
CAUTION
Section 10.1 Maintenance Procedure Overview
• Do not open the sipper safety cover while the analyzer is in operation. Otherwise, the operation will
stop. DO NOT open the sipper safety cover unless the analzyer is in Stand-by.
• Be sure to close the cover after you placed/replaced system reagents, or performed maintenance.
Otherwise, the analyzer will not operate.
• To open/close the sipper safety cover, press the proper spot that is indicated in this manual.
CAUTION
Section 10.1.18 Clean Mixer Paddle
Be careful not to damage the Mixer probe during cleaning.
CAUTION
Section: 10.1.7.2 Clean S/R Probe
Be careful not to damage the lower end of the S/R and sipper probe during cleaning.
CAUTION
Section 10.1.22 Clean Incubator and Aspiration Station
DO NOT use an acid solution or an alkaline solution to clean Incubator and Aspiration Station. The compartment is
made of aluminum and these solutions degrade the metal.

CAUTION
Section 10.1.1 Replace pipetter tube 510
Section 10.1.2 Replace pipetter tube 465 with nozzle seal
Section 10.1.6 Clean Rinse Stations for S/R Probe, Mixer and Sipper Probe
Section 10.1.7.1 Clean Sipper Probe
Section 10.1.7.2 Clean S/R Probe
Section 10.1.8 Clean water filter main pump
Section 10.1.9 Clean system water container
Section 10.1.11 Clean ProCell/CleanCell Compartments
Section 10.1.20 Check / Clean Gripper finger
Section 10.1.21 Clean light barriers and mechanic parts
Section 10.1.22 Clean Incubator and Aspiration Station
Section 10.1.30 Clean peltier elements from dust if necessary
Section 10.1.31 Clean BCR window and window reagent disk
Section 10.1.41 Clean the valve body on the system water container
Section 10.1.42 Exchange O-ring
Section 10.1.44 Exchange the spring at the gripper finger
Power must be off in order to move analyzer components. If power is on, the motors are engaged and attempted
movement may damage these components.
CAUTION
Section 10.1.6 Clean Rinse
Stations for S/R Probe, Mixer
and Sipper Probe
Any component that comes into
contact with sample fluids is
potentially biohazardous and should
be handled in an appropriate
manner. Wear protective gloves
when handling these materials.
CAUTION
Section 10.1.13 Check drain tubes for contamination and exchange if necessary
Section 10.1.14 Drain the outlet pipettor wash station and waste pipe
Section 10.1.15 Perform Liquid Flow Cleaning
CAUTION. WARNING. CORROSIVE. SysClean etc., cause severe burns. Keep out of reach of children. In case of
contact with eyes, rinse immediately with plenty of water and seek medical attention. Remove all contaminated
clothing immediately. Wear suitable gloves and eye/face protection.
CAUTION
If you spill SysClean etc., reagent on the analyzer, immediately clean the spill with distilled or deionized water.

WARNING
SysClean etc., reagent combined with the contents of the liquid waste container could cause potentially
harmful fumes.
CAUTION
If you spill SysClean etc., reagent on the analyzer, immediately clean the spill with distilled or deionized
water.
CAUTION
Section 10.1.10 Clean Liquid
Waste Container
WARNING
Section 10.1.10 Clean Liquid
Waste Container
DO NOT add bleach or strong
alkaline disinfectants (pH > 9.5) to
the liquid waste container.
Disinfectants combined with the
contents of the liquid waste could
cause potentially harmful fumes.
CAUTION
Section 10.1.11 Clean ProCell/CleanCell Compartments
DO NOT use an acid solution or an alkaline solution to clean the system reagent compartment. The compartment is
made of aluminum and these solutions degrade the metal.
CAUTION
Section 10.1.12 Clean Reagent
Disk and Compartment
CAUTION
Section 10.1.12 Clean Reagent Disk and Compartment
Take care not to scratch or smear the bar code reader window.

CAUTION
Section 10.1.3 Replace Pinch
Valve Tubing
Section 10.1.37 Exchange
Measuring Cell
Section 10.1.38 Exchange Tube
B for MC
B for Sipper with Nozzle seal
B for Sipper Syringe
Section 10.1.43 Exchange sipper
wash station
manner. Wear clean, protective
gloves when changing pinch valve
tubing.
WARNING
Section 10.1.3 Replace Pinch Valve Tubing
Section 10.1.3710.1-37 Exchange Measuring Cell
Section 10.1.38 Exchange Tube B for MC
Section 10.1.39 Exchange Tube B for Sipper with Nozzle seal
Section 10.1.40 Exchange Tube B for Sipper Syringe
Section 10.1.43 Exchange sipper wash station
There may still be some liquid in the tubing. The liquid that flows through this tubing comes from the
measuring cell and is potentially biohazardous. Wear gloves.
CAUTION
Section 10.1.3 Replace Pinch Valve Tubing
Make sure that you do not damage the fitting when replacing the tubing.
CAUTION
Section 10.1.4 Replace Pipettor Seals
For the S/R and sipper pipettor - loosen and REMOVE the locking screw to prevent damage to the glass barrel.
CAUTION
Section 10.1.5 Exchange packing fo sipper & pipetter syringe
Do not overtighten the pipettor retaining screw.
CAUTION
If the pipettor holder is not properly seated in its mounting block recess, damage to the pipettor assembly
may occur.
CAUTION
Section 10.1.5 Exchange packing fo sipper & pipetter syringe
The top and side tubing retaining nuts can be damaged if excessive force is applied when replacing them.
Take care not to cross-thread these nuts.

CAUTION
Section 10.1.9Check mixer speed; adjust if necessary
Before starting operation or after maintenance/checks, be sure that all analyzer covers are closed. DO
NOT open the analyzer covers while the analyzer is in operation.
Do not open the Reagent Disk cover while the analyzer is in operation.

10.1 Maintenance Procedure Overview

The following procedures are written for trained service engineer with a working knowledge of all
instrument mechanical functions, software displays and software functions. The instrument must be
provided with proper care and maintenance to ensure consistent and accurate functioning.
How to Use this Chapter

All maintenance procedures are listed in descending frequency. Each maintenance procedure is divided
into two parts: the Introduction and the Procedure.
The Introduction provides important information about the procedure, which includes:
• recommended frequency
• materials required
• time required
• precautions.
The recommended frequency is based on using the analyzer 8 hours per day, 5 days per week.
The materials required provides you with a list of all materials needed to perform each procedure.
The time required includes both operator time and analyzer time, when appropriate.
Precautions are included for your protection.
The Procedure gives step-by-step directions for performing the required maintenance function. This part
frequently is divided into smaller procedure blocks to help you organize your approach to maintenance.
Replacement Parts
A replacement part may be needed for a specific maintenance procedure. That part's description and
catalog number are included in the Materials Required table of each procedures' Introduction. Please use
the catalog number when ordering replacement parts. Remember, you are responsible for maintaining an
adequate spare parts inventory.
For most efficient use of time, gather all required materials before starting the maintenance procedure.
Maintenance Schedule
Detailed descriptions of the maintenance procedures listed below are found later in this chapter.
Table 10.1-1 Every 6 Months

Maintenance procedure every
Remarks
6 months
Liquid System 1. Replace pipettor tube 510
2. Replace pipettor tube 465 with nozzle
seal
3. Replace Pinch Valve Tubing Exchange the pinch tubes every 2months by
coustomer.
4. Replace Pipettor Seals (S/R and sipper)
5.Exchange packings for sipper & pipettor syringe
6. Clean Rinse Station for S/R probe ,Mixer and
Sipper Probe
7. Clean Sipper and S/R probe Clean sipper probe and S/R probe tip with 70%
isopropyl alcohol.
S/R probe only with distilled or deionised
water.
8. Clean water filter main pump
9. Clean System Water Container


Remarks
6 months
10. Clean Liquid Waste Container
11. Clean ProCell/CleanCell Compartments
12. Clean Reagent Disk and Compartment
Liquid System 13. Check drain tubes for contamination In case whole tubing system (except Sipper side)
and exchange if necessary seems to be contaminated perform cleaning
procedure with Perhydrol-solution.
Refer to chapter 3.3.2.
14. Drain the outlet pipettor wash station and waste use SysClean solution
pipe
15. Perform Liquid Flow Cleaning with new tubings The Service LFC is only necessary during PM visits
if the Sipper line is highly contaminated or if LFC
has not been carried out regularly by the customer.
16. Perform system volume check
17. Exchange mixer belt S
18. Clean mixer paddle Change if the paddle is bent
19. Check mixer speed; adjust if necessary 2000 rpm ± 100 in liquid
2050 ± 100 in air
Transport Unit 20. Check / Clean gripper finger clean gripper finger with soaked
(distilled or deionised water. ) cotton stick
21. Clean light barriers and mechanic parts
22. Clean incubator and aspiration satation
Voltage monitor 23. Check LLD voltage pipettor pipettor in upper dead point without Tip < 1.5V
24. Check LLD voltage sipper sipper in upper dead point < 3.5V
25. Check clot voltage after S/R prime 1.8V ± 1.3 ( P-sensor 2 )
Temperatur 26. Detection unit approx. 28°C; Target influenced by ambient
monitor temperature
27. Incubator 37°C
28. Reagent approx. 18°C; Target influenced by ambient
temperature
29. PC / CC 28°C
30. Clean peltier elements from dust if necessary
Barcode reader 31. Clean BCR window and window reagent disk
System 32. Perform artificial media check Refer to Chapter 6.3.2.3 and 2.3.13.1.
performance 33. Perform TSH assay test Refer to Chapter 6.3.2.4 and 2.3.13.2.
check 34. Perform initial blank cell Refer to Chapter 6.4.7 and 2.3.12.
35. Perform assay calibration Refer to Chapter 2.3.14 and Operator’s manual.
36. Perform assay control Refer to Chapter 2.3.14 and Operator’s manual.

Table 10.1-2 Every 12 Months

Remarks
12 months
Measuring Unit 37. Exchange measuring cell Exchange the measuring cell every 12 months or
after measuring 50,000 tests whichever comes first.
For installation refer to chapter 2.3.9.
38. Exchange tube B for MC Together with the measuring cell.
39. Exchange tube B for sipper with nozzle
seal
40. Exchange tube B for sipper syringe
Liquid 41. Clean the valve body on the system water
system container
42. Exchange O-ring SV 1 / 2 / 5 / 6 / 7 Solenoid valves above the magnet pump.
43. Exchange sipper wash station
Transport Unit 44. Exchange the spring at the gripper finger
10.1.1 Replace pipettor tube 510

Note: Read Safety Information
Recommended frequency: 6 Months at PM visits
Operator time: Approximately 15 minute.
Analyzer time: Approximately 15 minute.
Precautions: The operation switch must be OFF.
Materials Required Catalog Number
Gauze squares obtain locally
Distilled or deionized water -------
70% isopropyl alcohol -------
10.1.1.1 Procedure
Exchange Tube 510
1 ► Remove the cover until entering the following condition.
Figure 10.1-1 Removing the front cover
2 ► Remove GUIDE as shown in Figure 10.1-2.

Figure 10.1-2 Removing GUIDE
3 ► Remove COVER as shown in Figure 10.1-3.
Figure 10.1-3 Removing COVER
4 ► Draw out the Tube 510.

5 ► Remove Tube 510 on the side of P-SENSOR2 ASSY.
6 ► Use gauze etc. so that the drop of water might leak from the tube.

Figure 10.1-4 Removing Tube510 on the side of P-SENSOR2 ASSY
7 ► Remove Tube 510 on the side of JOINT 2.
Figure 10.1-5 Removing Tube 510 on the side of JOINT 2
8 ► Follow the reverse procedure of removing for installation.

9 ► After exchange Tube 510, operate the S/R Pipettor right and left. Because to take care about
drawing tube.
Prime the Pipettors
1 ► Open the Utility/Maintenance tab screen after initialization is complete. Select “Maintenance” in
the maintenance type list and then “S/R Pipettor Prime” in the maintenance item list. The S/R
Pipettor Prime pop-up window opens.
2 ► Type “10” in the text box and touch Start. The liquid system is purged of air.
3 ► During priming, check the pipettor and tubing connections for leaks. The plunger should be in
the correct position and must be moving up and down continuously.

10.1.2 Replace pipettor tube 465 with nozzle seal

Note: Read Safety Information
Procedure
Exchange Tube 465
Figure 10.1-6 Outline view of the pipettor
2 ► Remove the pipettor cover.

Figure 10.1-7 Removing the pipettor cover
3 ► Remove the tube 465 on the side of a nozzle.

Figure 10.1-8 Removing of the tube 465 on the side of a nozzle
5 ► Remove the tube 465 from PULLEY and PULLEY 1.

Figure 10.1-9 Removing the tube 465
6 ► Remove the tube 465 on the side of JOINT 2.
Figure 10.1-10 Removing the tube 465 on the side of JOINT 2

8 ► After exchange Tube 465, move the tube up and down. Confirm the tube doesn't come off from
PULLEY.
Prime the Pipettors

10.1.3 Replace Pinch Valve Tubing

NOTICE
Read Safety Information
Worn pinch valve tubing allows liquid to leak, thereby affecting the accuracy of the pipetting volumes and
the ability to properly clean the measuring cell.
Recommended frequency: 6 Months at PM visits.
Operator time: Approximately 2 minutes.
Analyzer time: Approximately 15 minutes.
Precautions: The operation switch must be OFF while changing the tubing.
Pinch valve tubing 741-0941
Purge the Tubing of Liquid
1 ► Select Utility -> Maintenance.

2 ► Select “Maintenance” in the maintenance type list box (left).
3 ► In the maintenance items list box (right), select “Measuring Cell Exchange“ and touch the
Select button.The Measuring Cell Exchange pop-up window opens.
4 ► Touch Start. The tubing is purged of liquid.
5 ► When the analyzer returns to Stand-by, power it OFF.
Remove the Tubing from the Fittings
The pinch valve tubing and fittings are located above the S/R and sipper pipettors. Refer to the reference
point photograph at the right and then to the enlarged view of the area in the photograph below.
Figure 10.1-11 Reference point for pinch valve tubing

Figure 10.1-12 Enlarged view of pinch value tubing and fittings
1 ► Remove the distilled water container and cover around the foot area of the pipettor unit with
paper towels
2 ► Carefully remove the pinch valve tubing from the fittings on the metal plate while holding a dry
gauze square around the tubing.
3 ► Use the gauze square to absorb liquid comes out of the released tubing.
4 ► Remove the tubing from the pinch valve and discard it.
5 ► Take a new piece of tubing and insert it through the pinch valve. Verify the tubing length is 180
mm. If not, cut the tubing to that length.
6 ► Carefully slide the ends of the tubing over each of the fittings. In the photo on the previous page,
one set of fittings is shown with solid red circles and the other pair of fittings is shown with
dotted red circles. Verify that each tubing end is connected to the appropriate fitting according
to the diagram shown below.
Figure 10.1-13 pinch valve tubing
7 ► Repeat the procedure for the other pinch valve tubing.

Prime the Sipper Pipettor
1 ► Power ON the analyzer.

3 ► Select “Maintenance” in the maintenance type list (left).
4 ► Select “Sipper Pipettor Prime” in the maintenance items list (right).
5 ► Touch Select. The Sipper Pipettor Prime pop-up window opens.
6 ► Type "10" in the text box.
7 ► Touch Start. The pop-up window closes and the system begins purging air out of the pipettor
system. While the system is priming, check for leaks at the fittings and on the tubing.
Prime the Measuring Cell

3 ► Select “Measuring Cell Preparation” in the maintenance items list (right).
4 ► Touch Select. The Measuring Cell Preparation pop-up window opens.
6 ► Touch Start. The pop-up window closes and the system begins priming the measuring cell with
ProCell. While the system is priming, check for leaks at the fittings and on the tubing.
NOTICE
If a fitting breaks while exchanging a pinch valve tube, exchange it with a new one by following the
procedure described below .
1. Remove the broken fitting by turning it counterclockwise.
2. Attach a new fitting on the valve block by turning it clockwise.
3. Proceed with the pinch valve tubing maintenance.
10.1.4 Replace Pipettor Seals

NOTICE
A worn seal piece allows liquid to leak, thereby affecting the accuracy of the pipetting volumes However,
should the seals require replacement between visits, instructions are provided below.

Precautions: The operation switch must be OFF while changing the seals.
S/R pipettor seal 741-1302
Sipper pipettor seal 741-1303
Spanner wrench 741-0919
Absorbent towels obtain locally
70% isopropyl alcohol obtain locally
Disassemble Pipettor
1 ► Disconnect the tubing at the top of the pipettor assembly by turning its retaining nut
counterclockwise.

Figure 10.1-14 Loosen pipettor retaining nut
2 ► Hold a dry gauze square or other absorbent material next to the side tubing of the pipettor;
disconnect this tubing by turning its retaining nut counterclockwise. Use the gauze square to
absorb water as it drains from the tubing.
Figure 10.1-15 Disconnect tubing
3 ► Loosen the knurled locking screw from the top of the pipettor assembly by turning it
counterclockwise.
Figure 10.1-16 Loosen knurled locking screw

4 ► Carefully pull the pipettor assembly out of its mounting block. With one hand, support the glass
barrel. With the other hand, grasp the pipettor holder and lift up, then out to remove the
assembly. Make sure the plunger is removed from the U-shaped slot.
Note: Avoid touching the top of the glass barrel.
Note: For sipper pipettor - pull the plunger down far enough so that you can lift out the glass barrel.
Then remove the remaining pipettor assembly.
Figure 10.1-17 Remove pipettor assembly
5 ► Remove the glass pipettor barrel. Set it aside in a safe place. Remove the o-ring that fits below
the pipettor barrel and set in a safe place.
Figure 10.1-18 Remove o-ring
Expose Pipettor Seal
1 ► Turn the pipettor holder upside down and expose the plunger retaining screw.
2 ► Apply the spanner wrench to the plunger retaining screw and turn the screw counterclockwise
until it is loose.
3 ► Turn the pipettor holder right side up and carefully lift the pipettor holder off of the plunger.
Leave all parts on the plunger.

Figure 10.1-19 Remove pipettor holder
Replace Pipettor Seal
1 ► Remove the seal piece, press piece, spring and retaining screw from the plunger. Dispose of
the seal piece.
2 ► Wipe the plunger with a gauze square soaked in 70% isopropyl alcohol to remove any debris.
Follow with a gauze square soaked with distilled or deionized water.
Figure 10.1-20 Remove S/R pipettor seal piece
Figure 10.1-21 Remove sipper pipettor seal piece

3 ► Ensure that the retaining screw, spring and press piece are properly positioned on the plunger.
Place the new seal on the plunger, verifying the rounded end is down. Refer to the graphic on
the right for the correct order of the individual parts. Although the actual components of the
sipper pipettor may not be the same size as those of the S/R pipettor, they are assembled in
the same order.
Figure 10.1-22 Pipettor assembly order
4 ► Place the plunger back in the pipettor holder with the pipettor vertically oriented. Tighten the
retaining screw with the spanner wrench until the screw is snug with the pipettor holder.
Figure 10.1-23 Tighten retaining screw
Reassemble Pipettor
1 ► Place the pipettor holder o-ring into the pipettor holder. If the o-ring appears damaged or worn,
replace it.
2 ► Inspect the glass pipettor barrel for chips or cracks at the top and bottom. If the pipettor barrel
is etched or damaged in any way, replace it. Place the pipettor barrel over the plunger and onto
the pipettor holder. It is easier to place the barrel back on if the barrel and pipettor holder are
dry.

3 ► Return the pipettor holder onto its mounting block by tilting the top of the pipettor toward the
instrument. Ensure that the pipettor holder is in the recess on the top surface of the mounting
block.
4 ► The notched (bottom) end of the plunger must be secured within the U-shaped notch of the
stepper motor.
5 ► Rotate the pipettor holder until the side tube port is positioned to accept the pipettor tubing.
6 ► Finger-tighten the top knurled locking screw. Ensure that the pipettor assembly is seated
correctly (not loose or crooked) and the glass barrel o-ring is properly positioned.
Figure 10.1-24 Secure plunger in notch
Figure 10.1-25 Replace retaining nut
7 ► Reconnect the pipettor's top tubing and finger-tighten its retaining nut.
8 ► Reconnect the side tubing and finger-tighten its retaining nut.
9 ► Turn the analyzer power ON.
Prime the Pipettors

4 ► If air bubbles are found on the plunger, gently tap on the glass barrel to remove the air bubbles.
If this is not successful, remove the pipettor and thoroughly clean the plunger again with a
gauze square soaked in 70% isopropyl alcohol.
5 ► Repeat steps 1 ► - 4 ►, if necessary.
6 ► When you change the sipper pipettor seal, repeat steps 1 ► - 5 ►, but select “Sipper Pipettor
Prime” instead of “S/R Pipettor Prime” in the maintenance items list.
Note: The sipper pipettor plunger does not move up and down during a sipper prime.
Prime the Measuring Cell
1 ► Power ON the analyzer.

4 ► Select “Measuring Cell Preparation” in the maintenance items list (right).
5 ► Touch Select. The Measuring Cell Preparation pop-up window opens.
7 ► Touch Start. The pop-up window closes and the system begins priming the measuring cell with
ProCell.
10.1.5 Exchange packings for sipper & pipettor syringe

NOTICE
Tweezers obtain locally
Procedure
Exchange packings for sipper & pipettor syringe

2 ► Remove the nipple on the side of a syringe.

Figure 10.1-26 Removing the nipple on the side of a syringe
4 ► The following Figure 10.1-27 is the top view after following the step 1.
Figure 10.1-27 Top view of the syringe with the nipple removed.
5 ► Remove packings with tweezers.

6 ► Must not damage the tube etc., by using tweezers.

Figure 10.1-28 Removing packings
Prime the Pipettors
the maintenance type list and then “S/R Pipettor Prime” and “Sipper Pipettor Prime” in the
maintenance item list. The S/R Pipettor Prime and Sipper Pipettor Prime pop-up window opens.
10.1.6 Clean Rinse Stations for S/R Probe, Mixer and Sipper Probe
NOTICE
Contamination in the rinse stations for the S/R probe, the mixer and the sipper probe can be responsible
for carryover. To prevent contamination, clean the rinse stations every 6 Months at PM visit.
Analyzer time: None.
Cotton swabs obtain locally
Syringe with attached tubing obtain locally
Distilled or deionized water ----------
(approximately 300 mL)
Procedure
1 ► Move the S/R probe and the mixer to an area away from the rinse stations. Also, open the
sipper safety cover and move the sipper probe to an area away from the rinse stations.

Figure 10.1-29 Move component away from rinse station
2 ► Take a syringe with tubing attached to its end (as in the photo on the right) and aspirate the
water out of the mixer rinse station.
3 ► Use a cotton swab soaked in 70% isopropyl alcohol to thoroughly clean the S/R probe, mixer
and sipper rinse stations.
4 ► Take another cotton swab soaked in distilled or deionized water and wipe the rinse stations
again.
5 ► Fill the syringe with distilled or deionized water and refill the mixer rinse station. This should
take approximately 50-100 mL of water. Also, flush the S/R probe and sipper rinse stations with
water (50-100 mL).
6 ► Aspirate the water out of the mixer rinse station again using the syringe.
7 ► Refill the mixer rinse station and flush all the rinse stations with distilled or deionized water one
final time.
8 ► When you power ON the analyzer, it performs the start-up reset operation, and each
mechanism returns to its home or Stand-by position.
Note: You may want to use two syringes for this procedure - one for aspirating liquid and the other
for refilling the rinse stations.
Figure 10.1-30 Aspirate/refill the rinse stations

Figure 10.1-31 Swab mixer rinse station
10.1.7 Clean Sipper and S/R probe
10.1.7.1 Clean Sipper Probe

NOTICE
Dirt on the sipper probe may cause contamination and carryover, and affect results. Clean this part at PM
visits to prevent contamination.
Distilled or deionized water obtain locally
Procedure
1 ► Open the sipper safety cover.
Note: How to open the sipper safety cover

Figure 10.1-32 Opening/closing the sipper safety cover (Push the circled point)
Figure 10.1-33 Sipper safety cover (when opened)
2 ► Move the sipper probe to an area where you can readily access it.
3 ► Wipe the outer surfaces of the sipper probe with a gauze square soaked in 70% isopropyl
alcohol. Follow with a gauze square soaked in distilled or deionized water.
4 ► When completed, close the sipper safety cover.
Figure 10.1-34 Sipper probe

10.1.7.2 Clean S/R Probe

NOTICE
Dirt on the sample/reagent (S/R) probe may cause contamination and carryover, and affect results.
Clean this part to prevent contamination.
Procedure
1 ► Move the S/R probe to an area where you can readily access it.
2 ► Wipe the outer surfaces of the S/R probe and probe tip with a gauze square soaked in distilled
or deionized water.
Figure 10.1-35 Wipe S/R probe
Figure 10.1-36 S/R probe tip

3 ► If the probe appears dirty, wipe the outer surfaces with a gauze square soaked in 70%
isopropyl alcohol. Follow with a gauze square soaked in distilled or deionized water.
10.1.8 Clean water filter main pump

NOTICE
Drainage container obtain locally
Procedure
1 ► Remove the System Water Container.

2 ► Open the cover for main pump part.
3 ► Shows the main pump part.
Figure 10.1-37 Main pump part
4 ► Prepare the drainage container.

5 ► Rotate the water filter to drain water by using a drainage container as shown in Figure 10.1-38

Figure 10.1-38 How to drain water
6 ► Remove the water filter.

7 ► Figure 10.1-39 shows the water filter.
Figure 10.1-39 Water filter
8 ► Dismanel the water filter.
Figure 10.1-40 Dismantling the water filter
9 ► Take FILTER NOZZLE part out from the water filter as shown in Figure 10.1-41 and clean it.

Figure 10.1-41 Taking out FILTER NOZZLE part
10.1.9 Clean System Water Container

A contaminated system water container can adversely affect analyzer performance. Clean the system
water container at PM visits.
Operator time: As needed.
Precautions: None.
Precautions: The analyzer must be in Stand-by or turn OFF the operation switch.
Cleaning brush obtain locally
Paper towels obtain locally
Procedure
1 ► Raise and remove the system water container.

2 ► Remove the cap and discard any water remaining inside.
3 ► Rinse the container with water, then follow with distilled or deionized water.
4 ► If the inside of the container appears dirty or contaminated use a large cleaning brush
immersed in 70% isopropyl alcohol to scrub the interior of the container. Rinse thoroughly with
distilled or deionized water.

Figure 10.1-42 Remove system water container
5 ► Remove the valve on the bottom of the system water container.

6 ► Clean the valve with a wet brush, then rinse with distilled or deionized water. If the valve
appears dirty, use a brush immersed in 70% isopropyl alcohol to clean the valve. Then, rinse
thoroughly with distilled or deionized water.
Figure 10.1-43 Valve body on the System Water Container
7 ► Use a gauze square to wipe and clean the aspiration inlet for distilled or deionized water supply,
located on the analyzer.
8 ► Connect the valve on the container bottom and fill the container with distilled or deionized water.
Then, dry the outside of the container with paper towels, attach the cap to the container and
return the container to the analyzer.

Figure 10.1-44 Aspiration inlet
10.1.10 Clean Liquid Waste Container

NOTICE
A full liquid waste container causes an alarm and interrupts operation. The liquid waste container must be
checked and emptied as needed.
Precautions: The analyzer must be in Stand-by or turn OFF the operation switch.
Do not execute System Reset or Reagent Scan, or power ON the
analyzer while cleaning the liquid waste container.
Paper towels obtain locally
optional - germicidal agent (pH - obtain locally
9)
Procedure
1 ► Pull the liquid waste container toward you, cap it and raise it carefully, while avoiding the liquid
waste outlet.
2 ► Place a folded paper towel under the waste outlet to catch any waste droplets that may fall.
3 ► Empty the container and rinse it thoroughly with water.
4 ► If the inside of the container appears dirty, use 70% isopropyl alcohol to rinse the container.
Follow with a thorough water rinse.
5 ► Wipe the outside of the container with a paper towel.
6 ► Use a paper towel to wipe the compartment where the container is to be placed.
7 ► OPTIONAL - Add the appropriate volume of a germicidal agent with a pH - 9 (as directed in its
product labeling) to the liquid waste container.

Figure 10.1-45 Remove liquid waste container
8 ► Remove the paper towel under the waste outlet and replace the liquid waste container. Push
the container forward so that the container opening is under the liquid waste outlet. Be sure to
remove the cap.
10.1.11 Clean ProCell/CleanCell Compartments

NOTICE
The system reagent compartment should be cleaned as needed to eliminate spills from the ProCell and
CleanCell reagents.
Distilled or deionized water ------
Procedure
1 ► Open the sipper safety cover. Push on the part indicated in the picture below.
Figure 10.1-46 Open the sipper safety cover

2 ► Move the sipper arm as far to the left as the arm will allow.
3 ► Remove the ProCell and CleanCell reagent bottles.
4 ► Wipe the inside of the compartments with damp, not wet, gauze squares. DO NOT allow water
to pool in the bottom of the compartments. Take care to avoid the photosensors in
compartment positions 2 and 3. These sensors check for the presence of the ProCell/CleanCell
bottle sets. They appear as rectangular windows located at the back of the compartment, just
below the top edge. If you should get the sensors wet, use a cotton swab to dry them.
Figure 10.1-47 Wipe ProCell/CleanCell compartments
5 ► Wipe the compartment with a dry gauze square.

6 ► Return the ProCell and CleanCell reagents to their respective system reagent compartments.
7 ► Close the sipper safety cover.
10.1.12 Clean Reagent Disk and Compartment

NOTICE
Reagent spills should be cleaned up as they occur. The reagent disk and compartment must be cleaned
every 6 Months at PM visits.
Distilled or deionized water ------
Cloth or lint-free towels obtain locally
Clean the Reagent Disk
1 ► Remove the cover from the reagent disk.

2 ► Loosen and remove the black thumbscrews on the center of the reagent disk.
3 ► Completely close the reagent pack caps and remove all the reagent packs from the reagent
disk.
4 ► Remove the reagent disk from the compartment.

Figure 10.1-48 Loosen and remove thumbscrews
5 ► Wipe the inside and outside of the reagent disk with gauze squares soaked with distilled or
deionized water.
6 ► If the disk appears dirty, use gauze squares soaked with 70% isopropyl alcohol to clean the
disk. Follow with gauze squares soaked with distilled or deionized water.
7 ► Dry the reagent disk with a cloth or lint-free towels. Set the reagent disk aside.
Figure 10.1-49Clean the inside of the reagent disk
Clean the Reagent Disk Compartment
1 ► Wipe the reagent disk compartment with gauze squares soaked with distilled or deionized
water.
2 ► If the compartment appears dirty, use gauze squares soaked with 70% isopropyl alcohol to
clean the compartment. Follow with gauze squares soaked with distilled or deionized water.
3 ► Dry the reagent disk compartment with a cloth or lint-free towels.
4 ► Return the reagent disk to the compartment. The disk is keyed; make sure that the alignment
pin on the center plate (refer to photo above) is aligned with the hole on the disk.
5 ► Securely reinstall the thumbscrews.
6 ► Place the reagent packs back into the reagent disk.
7 ► Replace the reagent disk cover and lock.

Figure 10.1-50 Clean the reagent disk compartment
10.1.13 Check drain tubes for contamination and exchange if necessary

NOTICE
Procedure

2 ► Remove the drain tube shown in Figure 10.1-51.
Figure 10.1-51 Removing the drain tube

Figure 10.1-52 COVER
3 ► Remove COVER.
4 ► Show the drain tube as shown Figure 10.1-53.
Figure 10.1-53 Drain tube at COVER
5 ► Remove the drain tube of RINSE STATION P2 part as shown Figure 10.1-54.

Figure 10.1-54 Drain tube of RINSE STATION P2 part
10.1.14 Drain the outlet pipettor wash station and waste pipe
NOTICE
SysClean obtain locally
Procedure
1 ► If the inside of the container appears dirty, use SysClean to rinse the drain the pipetter wash
station. Follow with a thorough water rinse.
10.1.15 Perform Liquid Flow Cleaning

NOTICE
Contamination in the sipper system could potentially degrade sample accuracy and precision, or possibly
block the measuring cell flowpath. To keep the sipper liquid flowpath clean and maintain the integrity of
the measuring cell, perform a liquid flow cleaning every 6 Months at PM visits.
High volume analyzers may require more frequent cleaning.
If customer maintenance has been done as recommended, it is only necessary to carry out an additional
customer cleaning at the PM visit. The service LFC is only necessary during PM if the sipper line is highly
contaminated or if LFC has not been carried out regularly by the customer.

Analyzer time: Approximately 16 minutes for User

Approximately 32 min + MC preparation
cycles for Service
Precautions:
SysClean obtain locally
SysClean adapter obtain locally
Pre-Cleaning Steps
1 ► Open the sipper safety cover.

2 ► Remove the ProCell bottle from position 3 of the system reagent compartment.
3 ► Fill the "USER" or “SERVICE” compartment of the SysClean adapter to the ledge of the
compartment with SysClean reagent.
Figure 10.1-55 Location of ledge in "USER" compartment of adapter
4 ► Carefully, insert the filled SysClean adapter into position 3 of the system reagent compartment.
Figure 10.1-56 SysClean adapter in position 3
5 ► Remove the liquid waste container and thoroughly clean it with distilled or deionized water.
6 ► Verify ProCell/CleanCell bottles are in positions 1, 2 and 4. Also, verify the bottle lids are open
and that there is adequate liquid in the bottles in positions 1 and 2.
Initiate Cleaning

2 ► Select “Maintenance” in the maintenance type list box (left).

3 ► In the maintenance items list box (right), select “Liquid Flow Cleaning” and touch the Select
button. The Liquid Flow Cleaning pop-up window opens.
4 ► Type "1" for User / Type “3” for Service in the text box and press Start. The system begins
cleaning the sipper liquid flowpath.
5 ► Perform Measuring Cell Preparation cycles in case of Service LFC.[Press ”MC Preparation” in
Maintenance screen; select number of cycles]
Post-Cleaning Steps
1 ► When the analyzer returns to Stand-by, remove the liquid waste container and thoroughly rinse
it with distilled or deionized water. Return the liquid waste container to the analyzer.
2 ► Open the sipper safety cover. Remove the SysClean adapter and properly discard any
remaining SysClean. Thoroughly rinse the adapter.
3 ► Return the ProCell bottle to position 3 of the system reagent compartment.
10.1.16 Perform system volume check

Refer to Chapter 6.3.1.
10.1.17 Exchange mixer belt S

NOTICE
Gauze squares -------
Procedure

2 ► Remove the mixer cover.

Figure 10.1-57 Removing the mixer cover
3 ► Remove the mixer belt S as shown in Figure 10.1-58.
Figure 10.1-58 Removing the mixer belt S

5 ► Execute “Check mixer speed” (See 10.1.19; adjust if necessary).
10.1.18 Clean mixer paddle

NOTICE

Procedure

2 ► Wipe the mixer paddle with gauze as shown in Figure 10.1-59.
Figure 10.1-59 Cleaning the mixer paddle
3 ► Confirm the mixer paddle is not curved.
10.1.19 Check mixer speed; adjust if necessary

NOTICE
Precautions: The operation switch must be ON
Procedure

2 ► As shown in Figure 10.1-60, put a white paper on the top of the mixer paddle and measure it
with the rotation meter.

Figure 10.1-60 Measuring the mixer speed
3 ► For the adjusting method, refer to the chapter 2.6.1 and 5.3.8.
10.1.20 Check / Clean gripper finger

NOTICE
Precautions: The operation switch must be OFF
Procedure

2 ► Figure 10.1-61 shows the gripper part.
Figure 10.1-61 Gripper part

3 ► Remove the gripper cover.
Figure 10.1-62 Removing the gripper cover
4 ► Shows the gripper fingers part.

5 ► Wipe it with a cotton swab with distilled or demonized water if it is dirty.
Figure 10.1-63 Gripper finges
6 ► Adjust the Gripper according to Chapter 4.5.1. If positioning shifts, must execute the adjustment.
10.1.21 Clean light barriers and mechanic parts

NOTICE
Wipe the each light barrier and mechanic parts if it is dirty.
10.1.22 Clean Incubator and Aspiration Station

NOTICE
Spills on the incubator could cause gripper movement alarms. The incubator and aspiration station
should be cleaned at PM visits.


Cotton swabs obtain locally
Procedure
1 ► Move the S/R arm to the far left and the gripper toward the front of the analyzer. Open the
sipper safety cover and move the sipper arm to the far right.
2 ► Clean the top of the incubator with gauze squares dampened with distilled or deionized water.
3 ► If the incubator appears dirty, use a slight scrubbing motion with the water-soaked gauze
squares. DO NOT use an acid solution or an alkaline solution to clean the incubator. The
incubator is made of aluminum and these solutions degrade the metal.
Figure 10.1-64 Wipe incubator surface
4 ► Next, wet a cotton swab with distilled or deionized water and swab each of the 32 positions on
the incubator, as well as the aspiration station.
5 ► Use a dry gauze square to dry the incubator when you are finished cleaning.
Figure 10.1-65 Swab incubator positions

10.1.23 Check LLD voltage pipettor

NOTICE
Refer to Chapter 5.3.4 and 6.3.3 Voltage Monitor
10.1.24 Check LLD voltage sipper

NOTICE
10.1.25 Check clot voltage

NOTICE
10.1.26 Check Temperature Monitor for Detection unit

NOTICE
Refer to Chapter 5.3.1, 5.3.6 and 6.3.4.
10.1.27 Check Temperature Monitor for Incubator

NOTICE
10.1.28 Check Temperature Monitor for Reagent

NOTICE
10.1.29 Check Temperature Monitor for PC / CC

NOTICE

10.1.30 Clean peltier elements from dust if necessary

NOTICE
Procedure

2 ► Remove the reagent disk shown in Figure 10.1-66.
Figure 10.1-66 Reagent disk
3 ► Remove the Reagent Jacket Assay

4 ► Puts Reagent Jacket Assay as shown like Figure 10.1-66.
5 ► Clean peltier elements with a gauze square soaked in distilled or deionized water If duty.
Figure 10.1-67 Reagent Jacket Assay

10.1.31 Clean BCR window and window reagent disk

NOTICE
Procedure

2 ► Figure 10.1-68 shows BCR window and window reagent disk.
Figure 10.1-68 BCR window and window reagent disk
3 ► Wipe BCR window with gauze.
Figure 10.1-69 Wiping BCR window

4 ► Wipe window of reagent disk with gauze.
Figure 10.1-70 Wiping window of reagent disk
5 ► In case of Rack Sampler, wipe BCR window for Sampler with gauze also.
10.1.32 Perform artificial media check

NOTICE
Refer to Chapter 6.3.2.3 and 2.3.13.1.
10.1.33 Perform TSH assay test

NOTICE
Refer to Chapter 6.3.2.4 and 2.3.13.2.
10.1.34 Perform initial blank cell

NOTICE
Refer to Chapter 6.4.7 and 2.3.12.
10.1.35 Perform assay calibration

NOTICE
Refer to Chapter 2.3.14 and Operator’s manual.

10.1.36 Perform assay control

NOTICE
Refer to Chapter 2.3.14 and Operator’s manual.
10.1.37 Exchange measuring cell

NOTICE
Recommended frequency: 12 Months at PM visits(Exchange the measuring cell every 12 months
or after measuring 50,000 tests whichever comes first.)
Procedure

2 ► Figure 10.1-71 shows CELL FRAME mounted inside Detection Unit.
Note: Do not need to remove the Rear Cover, usually.
Figure 10.1-71 CELL FRAME
3 ► Remove the measuring cell from CELL FRAME by removing the screw of the cell in two places..

Figure 10.1-72 Removing measuring cell
4 ► Figure 10.1-73 shows the measuring cell removed from CELL FRAME
Figure 10.1-73 Measuring cell

6 ► Please follow the procedure since chapter 2.3.9.
10.1.38 Exchange tube B for MC

NOTICE

Procedure

2 ► Figure 10.1-74 shows the inside of Detection Unit.
Figure 10.1-74 Inside of Detection Unit
3 ► Remove TUBE B FOR MEASURING CELL as shown in Figure 10.1-75.
Figure 10.1-75 Removing TUBE B FOR MEASURING CELL
4 ► Remove TUBE B FOR MEASURING CELL as shown in Figure 10.1-76.
Figure 10.1-76 Removing TUBE B FOR MEASURING CELL


10.1.39 Exchange tube B for sipper with nozzle seal

NOTICE


Procedure

2 ► Figure 10.1-77 shows tube B on the side of Sipper.
Figure 10.1-77 Tube B on Sipper side
3 ► Remove tube B on the side of Sipper as shown in Figure 10.1-78.

Figure 10.1-78 Tube B on Sipper side
4 ► Figure 10.1-79 shows tube B on the side of DETECTION UNIT
Figure 10.1-79 Tube B on DETECTION UNIT side
5 ► Remove tube B on the side of DETECTION UNIT as shown in Figure 10.1-80.
Figure 10.1-80 Removing tube B on DETECTION UNIT side


10.1.40 Exchange tube B for sipper syringe

NOTICE
Procedure

2 ► Figure 10.1-81 shows tube B on the side of measuring cell.
Figure 10.1-81 Tube B on measuring cell side
3 ► Remove tube B on the side of measuring cell as shown in Figure 10.1-82.

Figure 10.1-82 Removing tube B on measuring cell side
4 ► Remove TUBE B FOR SIPPER SYRINGE as shown in Figure 10.1-83.
Figure 10.1-83 Removing TUBE B FOR SIPPER SYRINGE
5 ► Figure 10.1-84 shows tube B on the side of DISPENSER SYRINGE ASSY

Figure 10.1-84 Tube B on DISPENSER SYRINGE ASSY side
6 ► Remove tube B on the side of DISPENSER SYRINGE ASSY as shown in Figure 10.1-85.
Figure 10.1-85 Removing tube B on DISPENSER SYRINGE ASSY side

10.1.41 Clean the valve body on the system water container

NOTICE

Procedure
1 ► Raise and remove the system water container.

2 ► Remove the cap and discard any water remaining inside.
Figure 10.1-86 Valve body on the System Water Container
3 ► Remove the valve on the bottom of the system water container if necessary.
10.1.42 Exchange O-ring SV 1 / 2 / 5 / 6 / 7

NOTICE
Procedure

2 ► Figure 10.1-87 shows SV 1 / 2 / 5 / 6 / 7.

Figure 10.1-87 SV 1 / 2 / 5 / 6 / 7
3 ► Remove the nipples attached to each SV’s as shown in Figure 10.1-88.
Figure 10.1-88 Removing the nipple
4 ► Remove the cover (SUPPORT R part) as shown in Figure 10.1-89.
Figure 10.1-89 Removing the cover

5 ► Remove PIPING BLOCK from each SV’s and O-ring’s shown in Figure 10.1-90.
Figure 10.1-90 O-ring
10.1.43 Exchange sipper wash station

NOTICE
Procedure

2 ► Figure 10.1-91 shows the surrounding part of sipper wash station.

Figure 10.1-91 Surrounding part of sipper wash station
3 ► Remove the screws putting sipper wash station and PLATE R together as shown in Figure
10.1-92.
Figure 10.1-92 Removing screws
4 ► Remove the screws of COVER and PLATE R as shown in Figure 10.1-93.
Figure 10.1-93 Removing screws of COVER and PLATE R
5 ► Remove the screws of WASHING STATION S(M) ASSY as shown in Figure 10.1-94.

Figure 10.1-94 Removing screws of WASHING STATION S(M) ASSY
6 ► Remove PIPE 1 shown in Figure 10.1-95.
Figure 10.1-95 PIPE 1
7 ► Remove the nipple shown in Figure 10.1-96.
Figure 10.1-96 Removing nipples
8 ► Remove sipper wash station as shown in Figure 10.1-97.

Figure 10.1-97 Removing sipper wash station
10.1.44 Exchange the spring at the gripper finger

NOTICE
Procedure
1 ► Figure 10.1-98 shows CARRIER Z ASSY.
Figure 10.1-98 CARRIER Z ASSY

2 ► Remove COVER Z as shown in Figure 10.1-99.
Figure 10.1-99 Removing COVER Z
3 ► Exchange the spring. If you cannot exchange the spring, then remove the Gripper Head for
safety and recommended it.
4 ► Adjust the Gripper according to Chapter 4.5.1. If positioning shifts, must execute the adjustment.

10.2 Operator Maintenance

Refer to the Operator’s Manual.

10.3 Maintenance Materials

Table 10.3-1 Contents of Preventive Maintenance Kit P/N : 741-0925 Name : 2010/e411 Service Kit
No Part name P/N Qty.
1 Tube 465 741-1175 1
2 Tube 510 741-1778 1
3 TUBE B FOR SIPPER 741-0820 1
4 TUBE B FOR MEASURING CELL 741-0822 1
5 SIPPER NOZZLE SEAL SET 741-0910 1 (total 2)
6 MIXING BELT 3 741-2244 1
7 P NOZZLE SEAL SET 741-0903 1 (total 2)
8 SPRING GRP 741-1168 1
9 SEAL PIECE S 741-1303 1
10 SEAL PIECE P 741-1302 1
11 TUBE B FOR SIPPER SYRINGE 741-0821 1
12 TUBE SET IH 741-0941 1 (total 2)
13 PACKING L443085 2 (total 2)
Table 10.3-2 Contents of Preventive Maintenance Kit P/N : 741-0926 Name : 2010/e411 2010 PM
KIT
1 Tube 465 741-1175 1
2 S NOZZLE SEAL 741-2065 1
3 MIXING BELT 3 741-2244 1
4 NOZZLE SEAL F729051 1
5 SPRING GRP 741-1168 1
6 SEAL PIECE S 741-1303 2 (total 2)
7 SEAL PIECE P 741-1302 2 (total 2)
8 WASHING STATION S 741-1380 1
9 O-RING NBR P9 L456006 2 (total 2)
10 O-RING NBR P16 L456013 2 (total 2)
11 VALVE BODY 741-1503 1
12 TUBE JOINT B2 741-1591 4 (total 4)
13 Tube Joint C 741-1609 1
14 TUBE SET IH 741-0941 4 (total 8)
15 PACKING L443085 4
Table 10.3-3 Additional Parts which has to be ordered for Preventive Maintenance ( Every 12 month )
1 MEASURING CELL 741-0461 1
2 VALVE BODY 741-1503 1
3 RINSE STATION P2 741-0997 1
4 O-RING NBR P4 L456001 5
5 O-RING NBR P5 L456002 5

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Roche Diagnostics / Hitachi

Service Manual Version 1.0

Date Number Version New Chapter

January 2006 Draft

8. Spare Parts/Recommended Parts

9. Host Interface (not applicable)

Chapter 1 System Description

1.1 INSTRUMENT ..............................................................................................................................................1 - 1

Chapter 2 Installation / Set Up

2.1 SITE REQUIREMENTS ..................................................................................................................................2 - 1

3.1 DESCRIPTION OF FLOW PATH .....................................................................................................................3 - 1

4.1 OVERVIEW .................................................................................................................................................4 - 1

5.1 BOARDS .....................................................................................................................................................5 - 1

Chapter 6 Service Software

6.1 OVERVIEW .................................................................................................................................................6 - 1

7.1 ALARM LIST ...............................................................................................................................................7 - 1

Chapter 8 Spare Parts/Recommended Parts

8.1 SPECIAL SERVICE TOOLS ...........................................................................................................................8 - 1

Chapter 9 Host Interface

9.1 HOST INTERFACE .......................................................................................................................................9 - 1

10.1 MAINTENANCE PROCEDURE OVERVIEW ................................................................................................10 - 6

1.1.1 System Configuration

Figure 1.1-1 cobas e411 disk system

Figure 1.1-2 cobas e411 rack system

Version 1.0 – May 2006 1-1 Chapter 1.1

1.1.2 System Introduction

Figure 1.1-3 Disk

Figure 1.1-4 Rack

1.1.2.1 The Control Unit

Figure 1.1-5 Control unit

Version 1.0 – May 2006 1-2 Chapter 1.1

1.1.2.2 The Analyzer Unit

The analyzer unit on the disk system consists of the:

Version 1.0 – May 2006 1-3 Chapter 1.1

1.1.2.3 Sample/Reagent Area

1.1.2.4 Consumables Area

1.1.2.5 Measuring Area

1.1.2.6 Operation Switch

Version 1.0 – May 2006 1-4 Chapter 1.1

1.1.3 Control Unit Components

1.1.3.1 Touchscreen Monitor

Figure 1.1-8 Touchscreen monitor

Version 1.0 – May 2006 1-5 Chapter 1.1

1.1.3.2 On-screen Keyboard

Figure 1.1-9 On-screen keyboard

1.1.3.3 External Printer

Figure 1.1-10 Location of the USB ports and Host port

1.1.3.4 Host Interface

Version 1.0 – May 2006 1-6 Chapter 1.1

1.1.4 Sample/Reagent Area Components

Figure 1.1-11 Sample Disk

Figure 1.1-12 Sample disk

Version 1.0 – May 2006 1-7 Chapter 1.1

Note: How to raise the sample disk protective cover

Figure 1.1-13 Sample disk protective cover

Figure 1.1-14 n Raising the sample disk protective cover

Version 1.0 – May 2006 1-8 Chapter 1.1

Figure 1.1-15 Standing angle

Figure 1.1-16 Limit angle