CAL 8000 Operator Manual PDF

CAL 8000 Auto Sample Processing System
Operator’s Manual
© 2014-2015 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2015-04.
Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
, are the trademarks, registered or otherwise, of Mindray in

China and other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party

Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
 all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel.
 the electrical installation of the relevant room complies with the applicable national and
local requirements.
 the product is used in accordance with the instructions for use.
I
 It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or injury of human health.
 Be sure to operate the system under the situation specified in this manual;
otherwise, the system will not work normally and the analysis results will be
unreliable, which would damage the system components and cause
personal injury.
 This equipment must be operated by skilled/trained clinical professionals.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or

unauthorized service people.
 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.
III
Customer Service Department
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan,
Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
IV
Table of Contents
1 Using This Manual ............................................................................................... 1-1
1.1 Introduction ............................................................................................................ 1-1
1.2 Who Should Read This Manual ............................................................................. 1-2
1.3 How to Find Information ........................................................................................ 1-3
1.4 Safety Information ................................................................................................. 1-4
1.5 Symbols ................................................................................................................. 1-7
2 Understanding the CAL 8000 System ................................................................ 2-1
2.1 Introduction ............................................................................................................ 2-1
2.2 System Configuration ............................................................................................ 2-2
2.3 Assemblies and Modules....................................................................................... 2-3
2.3.1 Loading Module ........................................................................................ 2-5
2.3.2 Track Module ............................................................................................ 2-9
2.3.3 Unloading Module .................................................................................. 2-16
2.3.4 Control and Management Module (CMU) .............................................. 2-20
2.3.5 System Accessories ............................................................................... 2-21
2.4 System Function .................................................................................................. 2-23
2.5 Software Interfaces and Operations (CMU software) .......................................... 2-25
3 Installing Your System ........................................................................................ 3-1
3.1 Introduction ............................................................................................................ 3-1
3.2 Installation Requirements ...................................................................................... 3-2
3.3 Moving and Installing the System .......................................................................... 3-4
3.4 Connecting the System ......................................................................................... 3-5
4 Preparations Before Using ................................................................................. 4-1
4.1 Introduction ............................................................................................................ 4-1
4.2 Notes before Using ................................................................................................ 4-2
4.3 Sample Preparation ............................................................................................... 4-3
4.4 Preparing the Tubes and Tube Racks ................................................................... 4-3
5 Operating Your System ....................................................................................... 5-1
5.1 Introduction ............................................................................................................ 5-1
5.2 Checks before Starting the System ....................................................................... 5-2
5.3 Startup ................................................................................................................... 5-3
5.4 Starting Analysis .................................................................................................... 5-4
5.5 Finishing Analysis .................................................................................................. 5-5
5.6 Notes during Analysis ............................................................................................ 5-6
5.7 Inserting a STAT Sample ....................................................................................... 5-7
5.8 Daily Quality Control of the Analyzers ................................................................... 5-8
5.9 Standby .................................................................................................................. 5-9
6 Operating the Control and Management Module (CMU) ................................. 6-1
6.1 Introduction ............................................................................................................ 6-1
6.2 Monitoring System Status ...................................................................................... 6-2
6.3 Monitoring Sample Analysis .................................................................................. 6-6
1
Table of Contents
7 Reviewing and Processing Sample Results ..................................................... 7-1

8 Servicing Your System ........................................................................................ 8-1
8.1 Introduction ............................................................................................................ 8-1
8.2 Cleaning................................................................................................................. 8-2
8.3 Replacing ............................................................................................................... 8-3
9 Troubleshooting .................................................................................................. 9-1
9.1 Introduction ............................................................................................................ 9-1
9.2 Error Information and Handling ............................................................................. 9-2
10 Data Managing Unit (DMU) ............................................................................... 10-1
10.1 Overview .............................................................................................................. 10-1
10.2 Reexam Record ................................................................................................... 10-2
10.2.1 Print Setup ...................................................................................... 10-2
10.2.2 Reexam Record Printing Status ..................................................... 10-4
10.2.3 Manual Printing the Reexam Record.............................................. 10-4
10.3 Acquire patient info. from LIS after the sample ID Editing................................... 10-6
10.4 Serial No. in LIS ................................................................................................... 10-7
10.5 Sample Traceability ............................................................................................. 10-8
10.5.1 Tracing the Information of A Certain Sample .................................. 10-8
10.5.2 Tracing Samples Corresponding to Specified Batch of
Reagent/Control ................................................................................................... 10-9
10.5.3 Tracing Reagent Information Used for Control Analysis .............. 10-10
11 Supplementary Reagent Loading (SRL) Module (Optional) .......................... 11-1
11.1 Overview .............................................................................................................. 11-1
11.2 Structure and Interfaces ...................................................................................... 11-2
11.3 Checking the Pressure of the SRL Module ......................................................... 11-4
11.4 Errors Related to the SRL Module ....................................................................... 11-5
A Glossary ...............................................................................................................A-1
B Specifications ......................................................................................................B-1
B.1 Classification ......................................................................................................... B-1
B.2 Ports ...................................................................................................................... B-1
B.3 Tubes ..................................................................................................................... B-1
B.4 Power Supply ........................................................................................................ B-1
B.5 Sound Pressure ..................................................................................................... B-1
B.6 Operating Environment.......................................................................................... B-2
B.7 Storage Environment ............................................................................................. B-2
B.8 Running Environment ............................................................................................ B-2
B.9 Dimensions and Weight ......................................................................................... B-2
B.10 Contraindication ..................................................................................................... B-3
B.11 Barcode Specifications .......................................................................................... B-3
B.12 EMC Description .................................................................................................... B-6
B.13 Safety Classification .............................................................................................. B-6
B.14 Input/Output Devices ............................................................................................. B-6
B.14.1 External Computer ...................................................................................... B-6
B.14.2 Printer (Optional) ......................................................................................... B-7
2
Table of Contents
B.14.3 USB Flash Disk ........................................................................................... B-7

C Index .....................................................................................................................C-1
3
1 Using This Manual
1.1 Introduction
This chapter explains how to use your Operator's Manual of CAL 8000 Auto Sample
Processing System (hereby referred to as CAL 8000), which is shipped with your CAL 8000
Auto Sample Processing System and contains reference information about CAL 8000 and
procedures for operating, troubleshooting and maintaining the system. Read this manual
carefully before operating your CAL 8000 and operate your CAL 8000 strictly as instructed in
this manual.
1-1
Using This Manual
1.2 Who Should Read This Manual

This manual is intended to be read by clinical laboratory professionals to:
 learn about the CAL 8000 hardware and software.
 perform daily operating tasks.
 perform system maintenance and troubleshooting.
1-2
Using This Manual
1.3 How to Find Information

This operator’s manual comprises 11 chapters and 3 appendices. Refer to the table below to
find the information you need.
If you want to … See …

learn about the intended use, system configuration, main 2 Understanding the CAL 8000
assemblies and modules, system functions, software System
interfaces and operations of the CAL 8000
learn about the installation requirements of the CAL 8000 3 Installing Your System
learn about the preparations before using the CAL 8000 4 Preparations Before Using
learn about the daily operations and process of sample 5 Operating Your System
processing of the CAL 8000
learn about the operations of the control and management 6 Operating the Control and
module of the CAL 8000 Management Module (CMU)
learn about the way to review and process analysis results of 7 Reviewing and Processing
the CAL 8000 Sample Results
learn about how to service the CAL 8000 8 Servicing Your System
learn about how to solve the problems of the CAL 8000 9 Troubleshooting
learn about new functions of the DMU after the analyzer is 10 Data Managing Unit (DMU)
connected to the CAL 8000
learn about the composition and functions of the 11 Supplementary Reagent
supplementary reagent loading module of the CAL 8000 Loading (SRL) Module
(Optional)
learn about the terms of the CAL 8000 A Glossary
learn about the technical specifications of the CAL 8000 B Specifications
1-3
Using This Manual
1.4 Safety Information

The following symbols are used to indicate danger and alert information in this manual.
When you see… Meaning

read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.

WARNING alerting you to an operating hazard that can cause
personnel injury.
CAUTION alerting you to a possibility of system damage or unreliable
analysis results.
NOTE alerting you to information that requires your attention.
1.4.1 Protection from Biohazards
 All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
 If any component of the auto sample processing system leaks, the leaked
liquid is potentially biohazardous.
 The surfaces of all parts of the auto sample processing system are
potentially infectious; take proper protective measures for operation or
maintenance.
WARNING
 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.
1-4
Using This Manual
1.4.2 Protection from Other Hazards
WARNING
 If any abnormal smell or fog are observed, power off the system and
disconnect the power plug immediately, or else fire, electric shock or other
hazards may occur.
 Do not touch the power cords inside the system, and make sure your hands
are dry when operating the system to avoid electric shock.
 Please check the firmness of all the doors and covers before running the
system.
 Make sure all the safety measurements are adopted. It is prohibited to

disable any safety device or sensor.
 Keep your clothes, hair and hands away from the moving parts to avoid
injury.
1.4.3 Using the System
CAUTION
 Keep blood, reagent and any other metal substances from getting inside the
system, or fog may be generated due to short circuit.
 Using pinboard may bring the electrical interference and the analysis results
may be unreliable. Please place the system near the electrical outlet to avoid
using the pinboard.
 Do not damage the power cord, put any heavy object upon it or pull it
forcefully.
 Power off the system before connecting it to external devices (e.g.,

computer), or else fire or electric shock may occur.
 Please take action to any alarm and error messages immediately.
 Please only install genuine software to prevent the computer from virus.
 It is recommended that you install anti-virus software on the computer and

scan for viruses periodically.
1.4.4 Maintaining the System
WARNING
 Contact the manufacturer or authorized distributors in time if any damaged
1-5
Using This Manual
part is found.
 Be sure to wear rubber gloves and use specified tools and accessories
when inspecting, servicing or maintaining the system. Wash your hands
with disinfectant after finishing the operations.
 Be careful when opening/closing and removing/installing the doors, covers

and boards of the system.
NOTE
 If the system stop running due to errors, the operator may deal with the
errors as instructed by the Operator's Manual; in case of errors not
specified in the manual, contact Mindray customer service department.
 Please use the system strictly as instructed by this manual.
1.4.5 Using Reagents
NOTE
 Use the reagents specified by the manufacturer only. Store and use the
reagents as instructed by instructions for use of the reagents.
 Check if the reagent tubes are properly connected before using the system.
 Let reagents equilibrate at room temperature for a while before using.
1.4.6 Disposing of Waste
WARNING
 Discard the system according to government regulations.
 Be sure to dispose of reagents, waste, samples, consumables, etc.

according to government regulations.
1-6
Using This Manual
1.5 Symbols
You will find the following symbols in this manual:
alerting you to a potentially biohazardous condition.

WARNING alerting you to an operating hazard that can cause
personnel injury.
CAUTION alerting you to a possibility of system damage or unreliable
analysis results.
NOTE alerting you to information that requires your attention.
You may find the following symbols of the system:
CAUTION
 During the daily use of the system, especially the cleaning process, the
operator shall ensure the intactness of the labels.
CAUTION, CONSULT ACCOMPANYING

DOCUMENTS.
Note: suggesting the users consult to
accompanying documents to get important
safety information.
BIOLOGICAL RISK
PROTECTIVE EARTH (GROUND)
FOR IN VITRO DIAGNOSTIC USE
SERIAL NUMBER
1-7
Using This Manual
DATE OF MANUFACTURE
MANUFACTURER
TEMPERATURE LIMITATION
HUMIDITY LIMITATION
ATMOSPHERIC PRESSURE LIMITATION
THE FOLLOWING DEFINITION OF THE

WEEE LABEL APPLIES TO EU MEMBER
STATES ONLY: THE USE OF THIS SYMBOL
INDICATES THAT THIS PRODUCT SHOULD
NOT BE TREATED AS HOUSEHOLD
WASTE. BY ENSURING THAT THIS
PRODUCT IS DISPOSED OF CORRECTLY,
YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES
TO THE ENVIRONMENT AND HUMAN
HEALTH. FOR MORE DETAILED
INFORMATION WITH REGARD TO
RETURNING AND RECYCLING THIS
PRODUCT, PLEASE CONSULT THE
DISTRIBUTOR FROM WHOM YOU
PURCHASED THE PRODUCT.
AUTHORISED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY
THE DEVICE IS FULLY CONFORMANCE

WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC
MEDICAL DEVICES 98/79/EC.
1-8
Using This Manual
Type Label Connotation Location
Power WARNING 1. Next to the power inlet of

1. CONNECT ONLY TO A
Warning the loading unit
PROPERLY EARTH
2. Next to the power inlet of
GROUNDED OUTLET.
2. TO AVOID ELECTRIC the unloading unit
SHOCK, DISCONNECT 3. Next to the power inlet of
POWER CORD PRIOR TO
each track module
REMOVING OR REPLACING
4. Next to the electric panel of
FUSE.
3. REPLACE FUSE ONLY WITH every cabinet
THE TYPE AND RATING
SPECIFIED.
1-9
Using This Manual
Transfer To avoid injury, do not put your 1. On top right of the

track hands between the interior and
nonterminal analyzer track
movement exterior transfer tracks when the
cover, next to the transfer
warning system is in operation!
track
2. On top left and right of the
nonterminal analyzer track
track
3. On top right of the
nonterminal SM&S track
track
4. On top left and right of the
nonterminal SM&S track
track
1-10
Using This Manual
Cabinet Be aware for pinching while On the top door rim of each
door opening or closing the door! cabinet
movement
warning
1-11
Using This Manual
Display To avoid injury, do not put your On the main body of the
supporting hand around the joints of the display supporting arm
arm supporting arm while the arm is
movement moving!
warning
1-12
Using This Manual
Biological Warning On the top covers of the

Hazard Biological risk loading module, unloading
module, and each track
module
1-13
Using This Manual
No. Type Label Connotation Location
1 Biological Warning On the front cover

Hazard Biological risk
2 Vent safety Warning On the side board

warning To avoid damaging the next to the vent
Supplementary Reagent Loading
Module, do not block the vent at
its side.
3 Power WARNING On the side board
1. CONNECT ONLY TO A
supply next to the power
PROPERLY EARTH GROUNDED
warning supply
OUTLET.
2. TO AVOID ELECTRIC SHOCK,
DISCONNECT POWER CORD
PRIOR TO REMOVING OR
REPLACING FUSE.
3. REPLACE FUSE ONLY WITH
THE TYPE AND RATING
SPECIFIED.
1-14
Using This Manual
4 Connector Caution: Keep the connectors On the side board

protection away from collision while next to the
warning transporting the module. reagent
connectors
CAUTION
 Make sure the symbols are in good condition during daily use and
maintenance.
1-15
2 Understanding the CAL 8000 System
2.1 Introduction
CAL 8000 Auto Sample Processing System forms a processing line together with Auto
Hematology Analyzer (hereby referred to as "Analyzer") and Auto Slide Maker & Stainer
(hereby referred to as "SM&S"), which achieves the automatic dispatching, distribution,
transport and reclaiming of in-vitro diagnostic samples, and management of the devices
connected.
2 1
Figure 2-1 Auto Sample Processing Line (2+1)
1 --- Analyzer 2 --- SM&S

3 --- Auto Sample Processing System
This chapter introduces the configuration, basic assemblies and modules, system functions
and software operation of the CAL 8000.
Understanding the CAL 8000 System
2.2 System Configuration

The number of track modules in the system is determined by the number of Analyzers and
SM&S connected in the auto sample processing line, 6 track modules can be configured at
most to transmit and distribute samples for 6 external devices connected.
Names of Assemblies Models Supported Function Introduction

Auto Hematology BC-6800, BC-6600 Analyzing blood or body fluid samples,
Analyzer providing sample cells analysis results
(Analyzer)
Auto Slide Maker & SC-120 Making sample slides

Stainer
(SM&S)
Auto Sample Processing CAL 8000 Forming a processing line together with
System the Analyzer and SM&S to transmit,
distribute and analyze in-vitro diagnostic
samples, and manage samples and data
after the analysis.
The Auto Sample Processing System has 8 configurations currently (based on the number of
the analyzer and Stainer): For example, “1 x Analyzer” means the track module supports the
connection to one Analyzer, “1 x Stainer” means the track module supports the connection to
one Stainer.
Configuration loading Unloading Nonterminal Nonterminal Terminal
module module analyzer track Stainer track track module
module module
Configuration 1 1 1 1 0 1 x Analyzer
Configuration 4 1 1 1 0 1 x Stainer
2-2
2.3 Assemblies and Modules

CAL 8000 The Auto Sample Processing System mainly includes the loading module, track
module (multiple choices of configuration), unloading module, control and management
module and accessories.
3 2
Figure 2-2 Front of the Auto Sample Processing System (configuration: 2+1)
1 --- Loading module 2 --- Track module

3 --- Unloading module
2-3
1
1
Figure 2-3 Switch and Port in the Front of the Auto Sample Processing System
(configuration: 2+1)
1 --- Power Switch of the Auto Sample 2 --- Power Switch of the computer
Processing System
 Power Switch of the Auto Sample Processing System

The power switch of the Auto Sample Processing System is on side of the Cabinet, it turns
on/off the system,
CAUTION
 Do not turn on/off the switch repeatedly within a short time (5 minutes) to
avoid damaging the system.
 Power Switch of the computer

The host computer is in the Cabinet. You may open the front door of the cabinet to turn on the
computer.
2-4
Figure 2-4 Switches and Ports in the Back of the Auto Sample Processing System
(configuration: 2+1)
1 ---Network port of the computer 2 --- Loading assembly power switch

(connecting LIS)
3 ---Network port of the exchanger 4 --- Pneumatic unit control port
5 --- Unloading assembly power switch 6 --- Power switch of track unit
 Network port of the computer (connecting LIS)

There is a network port in the back of the loading cabinet; it connects the computer of the
sample processing line and the LIS computer.
 Power switch of the loading assembly

It is in the back of the loading cabinet, it turns on/off the loading assembly.
 Network port of the exchanger

It is in the back of the unloading cabinet for the diagnosis of device status.
 Pneumatic unit control port

It is in the back of the unloading cabinet, it connects the pneumatic unit.
 Power switch of the unloading assembly

It is in the back of the unloading cabinet, it turns on/off the unloading assembly.
2.3.1 Loading Module

The loading module includes loading assembly and loading module cabinet. It
2-5
accommodates sample tube racks, reads barcodes of tube racks by barcode scanner and
sends the racks to specified track module.
1
2 2
1
3
3
4
5 6
6
Figure 2-5 Loading Module
1 --- Supporting arm assembly 2 --- Display

3 --- Loading assembly 4 --- Power switch
5 --- Computer 6 --- Cabinet door
The loading assembly is the entrance of the sample processing line. At most 20 tube racks
can be loaded to the loading assembly. The racks are loaded, scanned for barcodes, turned
and then sent to tracks, so that the samples can be analyzed by the analyzers. The loading
assembly allows you to prioritize STAT samples based on your needs by putting a tube rack
in front of all other racks.
The loading assembly consists of loading station, loading unit, pushing unit, direction change
unit, barcode scanner unit, key and indicator unit, ports unit, and display unit. See the
following figure.
2-6
Figure 2-6Loading Assembly
1 --- Display unit 2 --- Loading station unit

3 --- Key and indicator unit 4 --- Direction change unit
5 --- Pushing unit 6 --- Barcode scanner unit
7 --- Loading unit
 Key and indicator unit

The key and indicator unit consists of two keys and an indicator, the two keys are for station
resetting/mute and pushing.
2-7
Figure 2-7Key and indicator unit of the loading assembly
1 --- Indicator 2 --- Reset/Mute key

3 --- Push key
 Ports unit
The ports unit consists of station power switch, debug port and network port.
Figure 2-8 Ports unit of the loading assembly
1 --- Station power switch 2 --- Debug port

3 --- Network port
2-8
2.3.2 Track Module

The track module consists of track unit, support track unit and the cabinet. It receives sample
racks sent by the loading module, transports them to the analyzer for analysis, or to the
SM&S for slide making and staining, and then transports the processed sample racks to the
unloading storage region of the track module.
The track module has 3 configurations: nonterminal analyzer track module, nonterminal
SM&S track module and terminal track module.
The 3 configurations of track module can form auto sample processing line of different
configurations with any sets of analyzers, SM&Ss, cabinets, loading assemblies and
unloading assemblies. Take the 2+1 configuration(2 analyzers +1 SM&S) as an example, its
track module and sample processing line assembly are shown in the following figure.
Figure 2-9 Track Module
1 --- Analyzers 2 --- SM&S

3 --- Nonterminal analyzer track module 4 --- Terminal track module
5 --- Cabinet 6 --- Loading assembly
7 --- Unloading assembly
2-9
Track Module Configuration

 Nonterminal analyzer track module
Figure 2-10 Nonterminal analyzer track module
1 --- Analyzer 2 --- Nonterminal analyzer track assembly

3 --- Cabinet door 4 --- Reagent carriage and reagents
5 ---Waste carriage and waste 6 --- Pneumatic unit carriage and pneumatic
unit
2-10
 Nonterminal SM&S track module
Figure 2-11 Nonterminal SM&S track module
1 --- SM&S 2 --- Nonterminal SM&S track assembly

3 ---Pneumatic unit carriage and pneumatic 4 --- Cabinet door
unit
5 --- Waste carriage and waste 6 --- Reagent carriage and reagents
2-11
 Terminal track module
Figure 2-12 Terminal Track Module (Analyzer)
1 --- Analyzer 2 --- Terminal track assembly

3 --- Cabinet door 4 --- Reagent carriage and reagent
containers
5 --- Waste carriage and waste container 6 --- Pneumatic unit carriage and pneumatic
unit
2-12
Figure 2-13 Terminal Track Module (SM&S)
1 --- SM&S 2 --- Terminal track assembly

3 ---Pneumatic unit carriage and pneumatic 4 --- Cabinet door
unit
5 --- Waste carriage and waste container 6 --- Reagent carriage and reagent
containers
Track Unit Structure

In Figure 2-9, the track next to the unloading station is called terminal track, other tracks are
called nonterminal track. The difference between terminal and nonterminal track is that
terminal track has an additional posterior transfer track assembly. The lengths of the analyzer
track and SM&S track are different, and the tracks must be used in association with the
Mindray specified analyzers or SM&Ss.
2-13
Figure 2-14 Left Front View of Nonterminal Track
1 --- Status indicator 2 --- Reset/Mute key

3 --- Unit off-the-line key 4 --- Interior track
5 --- Exterior track
Figure 2-15 Left Front View of Terminal Track
1 --- Status indicator 2 --- Reset/Mute key

3 --- Unit off-the-line key 4 --- Interior track
5 --- Exterior track 6 --- Posterior transfer track assembly
Each track unit has an interior and an exterior track, the exterior track transports tube racks,
while the interior track is for the storage and positioning of tube racks, which assists the
2-14
analyzer or SM&S with sample processing.
Figure 2-16 Introduction of the Nonterminal Track
1 --- Anterior transfer track area 2 --- Loading buffer area

3 --- Analyzing area 4 --- Unloading buffer area
5 --- Exterior track waiting area
Figure 2-17 Introduction of the Terminal Track
1 --- Anterior transfer track area 2 --- Loading buffer area

3 --- Analyzing area 4 --- Posterior transfer track area
2-15
5 --- Exterior track waiting area
Figure 2-18 Tube Rack Moving Path of Nonterminal Track
Figure 2-19 Tube Rack Moving Path of Terminal Track
2.3.3 Unloading Module

The unloading module includes unloading assembly and unloading assembly cabinet. It
receives sample tube racks that have been processed from the unloading storage region of
the track module, so that users may collect them.
2-16
Figure 2-20 Unloading Module
1 --- Unloading assembly 2 --- Exchanger

3 --- Pressure gauge 4 --- Cabinet door
The unloading assembly is the exit of the sample processing line, the analyzed tube racks
stays here temporarily until you remove them. It can accommodate 20 tube racks at most.
The unloading assembly consists of receiving unit, unloading unit, boards unit, power unit,
key and indicator unit and ports unit, as shown in the following figure.
2-17
Figure 2-21 Unloading Assembly
1 --- Unloading station 2 --- Receiving unit

3 --- Unloading unit 4 --- Key and indicator unit
Key and indicator unit
The key and indicator unit contains two keys and an indicator.
Key 1: reset/mute key, it has the following functions:
1. Unloading error removing
2. Unloading self-test/initialization
3. Mute the sample processing line error alarm
Key 2: manual unloading
Functions of status Indicator:
 Unloading unit normal: green
 Unloading unit error/abnormal: red
 Unloading unit standby: yellow
2-18
Figure 2-22 Key and indicator unit of the unloading assembly
1 --- Indicator 2 --- Reset/Mute key

3 --- Manual unloading key
Ports unit
The ports unit consists of the unloading assembly power switch, pneumatic unit port, debug
port and network port.
2-19
Figure 2-23 Ports Unit of the Unloading Assembly
1 --- Network port 2 --- Debug port

3 --- Pneumatic unit control port 4 --- Station power switch
2.3.4 Control and Management Module (CMU)

The CMU is the software system integrated in PC. You may run the CMU from an external
display to monitor the modules and devices of the sample processing line, track sample flow,
set up orders and view samples that have not been analyzed.
2-20
2.3.5 System Accessories

Pneumatic Unit
Figure 2-24 Front of the Pneumatic Unit
1 --- Safety valve 2 --- Operation indicator
2-21
Figure 2-25 Back of the Pneumatic Unit
1 --- Power switch 2 --- Power socket

3 --- Control port 4 --- Vacuum port
5 --- Pressure port
Tube Rack
See 4.4.1Specifications of Applicable Tubes and Tube Racks for tube rack specifications.
PC
Display
Wires (power cords, network cords)
2-22
2.4 System Function

2.4.1 Tube Rack Loading
Able to accommodate up to 20 tube racks (200 tubes) with to-be-analyzed samples.
2.4.2 Tube Rack Unloading

Able to accommodate up to 20 tube racks (200 tubes) with analyzed samples.
2.4.3 Unloading Module Full Reminder

Able to remind the operator when the unloading module is full of tube racks.
2.4.4 Tube Rack Barcode Identification

Able to scan and identify the barcodes of tube racks.
2.4.5 Consecutive Analysis of Tubes in Adjacent Racks

Seamless analysis of tubes in adjacent tube racks.
2.4.6 Separate Adjacent Tube Racks

Able to separate adjacent tube racks in the seamless analysis.
2.4.7 Tube Rack In-position Detection

Able to detect whether a tube arrives at the dispatched position.
2.4.8 Track Changing

Able to transfer tube racks between tracks.
2.4.9 Working-storage of Tube Racks

Able to store a certain number of tube racks with to-be-analyzed samples and those with
analyzed samples while working.
2.4.10 Increased Flexibility of Operating the Touch Screen
2-23
The touch screen is able to move in varied directions, which increases the flexibility of
operation by users.
2.4.11 Tube rack Transportation

Able to transport tube racks from the loading module to the track module, and then the
unloading module.
2-24
2.5 Software Interfaces and Operations (CMU

software)
This chapter only introduces the CMU software interfaces and operations of the PC, the
software operations of the data management unit (DMU) of the analyzer are introduced in the
Operator's Manual of the analyzer.
2.5.1 Software Interfaces

Special Sample
Tab Area Information Area Icon Area
Floating Button Client Area

Tab Area
Includes “Instrument Status”, “Sample Tracking”, “Order Setup” and “Log” tabs.
Instrument Status
This area displays the status of each module of CAL 8000 and each instrument (including
reagents) connected to it.
Sample flow tracking
This area displays the "Sample ID", "Mode", "Time of Analysis", "Position" and whether
reexam of the sample is required.
Order Setup
Set up analysis mode for the samples within the barcode range of a specified tube rack.
2-25
Sample Analysis Area

Include the information of “Not analyzed sample(s)”, “Suspect Samples” and “Barcode
Unidentified Sample”.
Icon Area
The title panel displays CMU titles and buttons.
Name Icon Function
Pause/Continue Pause/Continue the loading
/
Shutdown Shut down the auto sample processing
system
More Click to display more icons
About Click to see information about the current

software
Minimize Click to minimize CMU windows
Close Click to close the CMU software
Floating Button
Switch between the DMU and CMU. The button can be dragged to anywhere desired on the
screen.
Client Area
Displays the information of the current tab.
2.5.2 Software Operations

Drag Scroll Bar
On some screens, the information cannot be fully displayed in one page, then a scroll bar
(horizontal/vertical) will appear. You may scroll the scroll bar in the following ways to check
the rest of the information. A scroll bar is shown below:
2-26
Click the arrow button on the scroll bar.
Move the pointer to the slide bar, left click the mouse and hold, then scroll the bar at will.
Click the blank area on the scroll bar.
Tab Screen
Tag screen displays one page of the multi-page information.
Dialog Box
There are several types of dialog box based on different functional buttons in the dialog box,
which are "OK" dialog, "OK/Cancel" dialog box, "Yes/No" dialog box, "Yes/No/Cancel" dialog
box, and some special prompt boxes.
A dialog box consists of title panel, information area and functional buttons. The following
figure is a "Yes/No/Cancel" dialog box.
2-27
After modify the settings, click "yes", and the dialog box will be closed with the change saved;
click "No", and the dialog box will be closed without saving the change; click “Cancel” to close
the dialog box without saving the change, and go back to the previous screen.
2-28
3 Installing Your System
3.1 Introduction
WARNING
 Installation by personnel not authorized or trained by Mindray may cause
personal injury or damage your system. Do not install your system without
the presence of Mindray-authorized personnel.
 The installation, authorization, upgrade and modification of the system

software must be performed by Mindray-authorized personnel.
Your system has been tested before it is shipped from the factory. The system was carefully
packaged and labels were placed to tell the carrier how to treat this system. When you receive
your system, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately.
3-1
Installing Your System
3.2 Installation Requirements

3.2.1 Space Requirements
While installing the system, make sure there is enough space left for service and maintaining
operations, as well as for the system to dissipate heat and for the fluidic tubing to be properly
placed without extrusion. Specific requirements shown as follows:
 at least 500mm to the left/right of the system;
 at least 600mm above the system;
 at least 250mm behind the system;
 The ground where the system is placed shall be able to withstand at least 1880kg of
weight.
3.2.2 Power Requirements
WARNING
 Make sure the system is properly grounded.
 Before turning on the system, make sure the input voltage meets the
requirements.
CAUTION
 The connection of the system and the power shall only be completed by the
service engineer authorized by the manufacturer.
 All cables selected for use shall match the configuration of the system.
 The switch or circuit-breaker used for the system shall meet the following
requirements:
1. a switch or circuit-breaker shall be included in the building installation;

2. it shall be in close proximity to the equipment and within easy reach of
OPERATOR;
3. it shall be marked as the disconnecting device for the equipment.
Voltage Frequency Power

Loading Module 100V-240V~ 50/60Hz 100VA
Unloading Module 100V-240V~ 50/60Hz 100VA
Nonterminal 100V-240V~ 50/60Hz 100VA
Analyzer Track
Module
3-2
Nonterminal 100V-240V~ 50/60Hz 100VA

SM&S Track
Module
Terminal Track 100V-240V~ 50/60Hz 100VA
Module
Compressor a.c. 110V/115V ±10% 60Hz ±2Hz 600VA
a.c. 220V/230V ±10% 50Hz ±2Hz 450VA

60Hz ±2Hz 300VA
3.2.3 General Environment

Working Storage Operation
Environment Environment Environment
Ambient 15℃～32℃ 5℃～40℃
-10℃～40℃
Temperature
Relative Humidity 30%～85% 10%～90% 10%～90%
Atmospheric 70kPa～106kPa 70kPa～106kPa
50kPa～106kPa
Pressure
 The environment shall be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
 It is advisable to evaluate the electromagnetic environment prior to operation of this
system.
 Do not use this system in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper
operation.
 Do not place the system near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
 Do not place the system in direct sunlight or in front of a source of heat or drafts.
 The environment shall be ventilated.
 Do not place the system on a slope.
 Connect only to a properly earth grounded outlet.
 Only use this system indoors.
NOTE
 Only store and use this system in specified environmental conditions.
3-3
3.3 Moving and Installing the System
WARNING
 Installation by personnel not authorized or trained by Mindray may cause
personal injury or damage your system. Do not install your system without
the presence of Mindray-authorized personnel.
CAUTION
 Installation of unauthorized software in the PC or using the PC for any
unintended purposes may impact stability of the system or result in
incorrect data. Please only use the external PC for sample analysis and the
related purposes.
Moving and installation of the system shall be conducted by Mindray-authorized personnel. Do

not move or install your system without the presence of Mindray-authorized personnel.
3-4
3.4 Connecting the System
Refer to the Operator's Manual of the analyzer or SM&S for the connections of the device in
the sample processing line, its accessories and/or reagents.
The connection of each module of the CAL 8000 shall be conducted by Mindray-authorized
personnel.
3-5
4 Preparations Before Using
4.1 Introduction
This chapter introduces the preparations required before using the CAL 8000, including notes
before use, sample preparation, and preparation of tubes and tube racks.
4-1
Preparations Before Using
4.2 Notes before Using

 Do not put any heavy object or press heavily on any part of the system to avoid
affecting sample transportation or analysis, or distorting any component.
 Do not disconnect any connection cord to avoid errors.
 Make sure enough tube racks are prepared

As tube rack ID are matched with sample ID for tube position recognition, prepare enough
tube racks for sample analysis of the whole day before running the system.
4-2
4.3 Sample Preparation

Refer to the Operator's Manual of the analyzer for the sample preparation of the sample
processing system.
4.4 Preparing the Tubes and Tube Racks

4.4.1 Specifications of Applicable Tubes and Tube Racks
Tubes
Sizes of tubes supported: 11-13mm (outer diameter) ×65-78mm/80-83mm (without cap/with
cap)
80-83mm
65-78mm
11-13mm
Figure 4-1Tube Sizes
NOTE
 Some tubes may not adapt to the tube rack (e.g. tubes with unique caps), in
such case, contact Mindray customer service department.
Tube Rack
To ensure proper running of the system, be sure to use the standard configured tube rack of
the CAL 8000. See the following figure for size of the tube rack:
4-3
55mm
200mm
25mm
Figure 4-2 Size of Tube Rack
4.4.2 Placing Barcodes

Before analyzing samples, barcodes must be stuck on sample tubes for sample identification.
To ensure good readability of the barcode, you must place the label properly.
CAUTION
 The following errors may cause misreading of barcodes:
The barcode is not stuck upright.

Use of unqualified barcodes.
There are blood, powder or other contaminators on the surface of the barcode.
 To ensure good readability of barcodes, do as follows:
Stick the barcode correctly, as shown in Figure 1.

Use qualified barcodes mentioned in Appendix B.11 Barcode Specifications.
Keep the surface of the barcode clean and free of dust.
NOTE
 If several labels are stuck to one tube, or the label is misplaced, peeled or
wrinkled, it may cause autoloading error. To avoid such error, the notes
4-4
below shall be followed:
The label shall be stuck properly, as shown in Figure 4-3.

Do not stick several labels to one tube.
The surface of the label shall not be wrinkled.
Do not use barcode label which is easily peeled to prevent the label from
peeling.
Ensure that the tube with barcode label can be taken out from and placed
back to the rack easily.
Stick the barcode to the tube as the following figure shows.
Figure 4-3 Where to place the barcode label
Figure 4-4 How to place the barcode label
4.4.3 Preparing Tube Racks

Put the tube with barcode stuck to the corresponding tube position as shown in the following
4-5
figure.
4.4.4 Preparing Slides and Slide Baskets (SM&S Configured)

See the operator’s manual of the slide maker & stainer.
4-6
5 Operating Your System
5.1 Introduction
This chapter introduces the daily operating process of the CAL 8000 from startup to
shutdown.
A flow chart presenting the common daily operating process is shown below:
Start up the system

See 5.3 Startup
Run daily QC of the analyzer

See Operator’s Manual of the analyzer
Initial checks
See Chapter 4 Initial Checks
Sample Analysis
Auto analysis using the system Offline analysis
See 5.4 Starting analysis See Operator’s Manual of the analyzer
Reviewing and Processing Sample Results
See chapter 7 Reviewing and Processing Sample Results
Shutdown the system

See 5.5 Finishing Analysis
5-1
Operating Your System
5.2 Checks before Starting the System

Perform the following checks before turning on the system.
them are potentially biohazardous. Wear proper personal protective
when handling them and the contacted areas in the laboratory.
WARNING
 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.
 Keep your clothes, hairs and hands away from the moving parts to avoid
injury.
 Checking reagents
Check if there are enough reagents for analysis of the whole day, if not, replaces the
reagents.
If reagent runs out during analysis process, the device will stop running automatically
and remind you to replace the reagent. You shall replace the reagent to continue with the
analysis.
 Checking the waste container (for non-direct discharge)

Check and make sure waste containers of the analyzer(s) and SM&S(s) are empty.
 Checking the SM&S (if configured)

Check if there are sufficient slides in the SM&S for analysis of the whole day, if not,
prepares more slides.
Check if there are sufficient slide baskets.
Check if the slide basket unloading tray is cleared.
 Checking the auto sample processing system

Checking the auto sample processing system. Make sure there are no objects on the
tracks or the unloading tray. If there are any, remove them.
5-2
5.3 Startup
Start up the system as per the following procedure:
1. Turn on the power switch of the CAL 8000.
2. Open the cabinet door of the loading module, and turn on the power switch of the PC
inside the cabinet.
3. Log in the DMU software.
4. Wait for all modules and instruments to get ready (the status indicators displayed on
CMU are green).
5-3
5.4 Starting Analysis

Before starting the analysis, check:
whether there are clumps in the sample, and whether the sample volume is sufficient for
analysis;
whether the sample ID barcodes are stuck to the tubes to be analyzed as instructed by
4.4Preparing the Tubes and Tube Racks.
After the samples are well prepared, follow the procedure below to process and analyze
samples.
1. Order setup (optional)
If necessary, you may set up the analysis mode for samples within a certain range of
tube rack IDs using the "Order Setup” function of the CMU software. The procedure is
as follows (see 6.3.2 Order Setup for details):
1） Click "Order Setup" to enter the tab screen.
2） Click "Add", a new line will be added to the order list.
3） Define the "Rack Barcode From" and "To" in the added line, and then set up
analysis mode as needed.
4） Click "Save" to save the settings.
NOTE
 Analysis will be run in the defined mode if the tube rack ID scanned has
its matched order in the system; or else, analysis will be run in the mode
of the default order.
2. Put the tube racks with tubes loaded to the loading assemblyalong the guiding
grooves in order, with the opening of the tube tacks facing the operator.
3. Once the tube racks are placed in the loading assembly, the sample processing line
starts to transport the racks, scan rack IDs and sends them to the intended device for
analysis based on the order settings.
4. Operators may add tube racks to the loading assembly and take away tube racks that
have been analyzed from the unloading assembly as needed. The maximum capacity
of the loading and unloading assemblies is 20 tube racks. Alarm sound will be made
when the unloading assembly is full.
5. If SM&S is configured, add slide baskets on the basket loading tray when needed,
and remove the baskets from the unloading tray timely.
5-4
5.5 Finishing Analysis
Close the system as per the following procedure:
1. Exit the SPU software of all analyzers in turn. The procedure is as follows:
1） Tap "Menu">"Shutdown" on the main screen.
2） Tap "Yes" to perform the shutdown procedure; the dialog box will be closed
automatically.
2. Check to see if all analyzers are ready for the probe cleanser maintenance.
3. Perform shutdown probe cleanser maintenance to each of the analyzers. See the
operator’s manual of the hematology analyzer for details.
4. Exit the CMU software. The procedure is as follows:
1） Click the close button on the upper right of the screen, a dialog box will
display.
2） Tap "OK" to close the dialog box and exit the CMU software.
5. Turn off the power switch of the Auto Sample Processing System.
5-5
5.6 Notes during Analysis
 Do not open any cover of the system during analysis

to avoid errors.
 Do not take away tube racks during analysis

Do not take away tube racks when they are being transported from the loading tray to the
scanning position or when they are on any track module; they can only be taken away when
they enter the unloading module.
 Do not load tube racks during analysis

Do not place tube tacks to any track module during sample analysis; tube tacks can only be
placed in the loading tray.
 Do not reuse the same tube rack within one day

As tube rack ID are matched with sample ID for tube position recognition, do not reuse the
same tube rack within one day.
5-6
5.7 Inserting a STAT Sample

When a STAT sample needs to be analyzed immediately when the sample processing line is
working, you can either analyze it in open-vial using the STAT function of the analyzer, or
insert a new tube rack loaded with the STAT sample (see the steps below for details).
1. Place the well prepared STAT sample tube (see the operator’s manual of the analyzer
for how to prepare samples) in a tube rack.
2. Press the push key of the loading assembly (shown in the figure below), and the
loading assembly will push back the current tube rack at the forefront of the loading
tray.
3. Put the tube rack with the STAT sample at the forefront of the loading tray, and the
system automatically transport it to the track module, and then to an analyzer.
5-7
5.8 Daily Quality Control of the Analyzers

In an auto sample processing line configured with more than one analyzer, the daily quality
control of the analyzers can be performed by the way below.
1. Place the well prepared vial of control (see the operator’s manual of the analyzer and
instructions for use of the control for how to prepare controls) in a special QC tube
rack.
NOTE
 Do not place the control in a normal tube rack, or the system cannot
identify it.
2. Place the tube rack loaded with the control on the loading tray, with the opening of the
rack facing the operator.
3. Once the tube rack is place on the loading tray, the system starts to transport to the
scanning position.
4. After the system identified the QC rack, it will transport the rack to all analyzers which
enabled QC function for QC analysis.
5. After all analyses finished, the QC tube rack will be transported to the unloading tray.
5-8
5.9 Standby
When all instruments connected by the CAL 8000 are in standby mode, and the system is in
idle state for more than 30 minutes, all modules of CAL 8000 will go to the standby mode. To
exit standby, place a tube on the loading tray (not applicable when the autoloading function is
disabled or the loading module has error), or make any of the instrument in the processing
line exit the standby mode (see the operator’s manual of the instrument for how to exit
standby).
5-9
6 Operating the Control and Manageme
nt Module (CMU)
6.1 Introduction
The CMU is the software system integrated in PC. You may run the CMU from an external
display to monitor the modules and devices of the sample processing line, track sample flow,
set up orders and view samples that have not been analyzed.
This chapter introduces the functions and operations of the CMU module of CAL 8000.
6-1
Operating the Control and Management Module (CMU)
6.2 Monitoring System Status

The CMU status monitoring area displays the status of each unit/device of the sample
processing line from right to left. You may check the reagent consumption status, running
status and connection status of each device, and set up information on each unit/device.
The following figure is the CMU status monitoring area of a 2+0 sample processing line. It
displays the status of each SPS module/instrument from right to left: loading module,
analyzer 1 and its track module, analyzer 2 and its track module, and unloading module.
Instrument Status
Reagent
Status
Status of CAL 8000 Modules
 SPS Module Monitor

The status of the CAL 8000 modules and instruments are shown by the indicating bars: when
the bar is green, the module is working properly; when the bar is red, the module has error(s);
when the bar is grey, the module is power-off/not started.
Checking the error information

Tap the status monitor area of the module you want to check, and the dialog box below pops
up, showing the “Error Info.” and the “IP address” of the module.
6-2
Tap “Close” to close the dialog box.
Setting up the track information

Tap the “Setup” button in the “Track Info.” dialog box, and the dialog box below pops up.
To edit the IP address of the module, enter the desired IP in the “IP Setup” field, and tap
“OK”.
For the loading module, there is an “Autoloading” switch in the setup dialog box. Switch
on/off to enable/disable the autoloading function. If the switch is blue, the function is enabled;
if it is grey, the function is disabled.
 Instrument Monitor
The status of the CAL 8000 modules and instruments are shown by the indicating bars: when
the bar is green, the module is working properly; when the bar is red, the module has error(s);
6-3
when the bar is grey, the module is power-off/not started.
Checking the error information

Tap the status monitor area of the module you want to check, and the dialog box below pops
up, showing the “Error Info.” and the “IP address” of the module.
Setting up the instrument information

Tap the “Setup” button in the “Track Info.” dialog box, and the dialog box below pops up.
To edit the IP address of the module, enter the desired IP in the “IP Setup” field, and tap
“OK”.
To edit the instrument name, enter the desired IP in the “Instrument Name” field, and tap
“OK”.
 Reagent Monitor
The CMU displays the reagent status using bars in different colors (as shown in the figure
below).
6-4
Tap on this area and the dialog box below pops up, showing the reagent staus details.
6-5
6.3 Monitoring Sample Analysis

6.3.1 Sample flow tracking
In this tab, you can check the current position of a sample, and export the position information
of samples in specified period of time.
The indications of column heads in the sample flow tracking table are shown as follows:
Column Head Indication
Sample ID ID of the sample, which can be edited by double-click on the
desired item. The change will be synchronized to LIS
Position The tube position where the sample is accommodated,
th
e.g.: ”16-5” refers to the sample in the 6 tube position of the
tube rack with the ID 16
Loading Tray The time when the sample reaches the tube rack scanning
position of the loading module
Instrument 1/2/3…… The time when the sample reaches aspiration position the
instrument
Unloading Tray The time when the sample reaches the unloading module
Reexam If the sample needs to be re-examined according to the
reexam rule of the corresponding analyzer, “Reexam
suggested” will be displayed
 Export
To export the sample position information, do as follows:
6-6
1. Click “Export”, and the dialog below will pop up.
2. Specify the “Date Range”, and the enter or browse to the directory you want to save
the exported file.
3. Click “OK” to close the dialog box and start exporting.
 Editing the sample ID
1. Double click on the desired item, and the dialog box below pops up.
2. Enter the new sample ID, and tap “OK”.
6.3.2 Order Setup

Set up analysis mode for the samples within the barcode range of a specified tube rack.
6-7
 Adding a new order

You can add a new order as follows:
1. Click "Add", a new line will be added to the order list.
2. Define the "Rack Barcode From" and "To" in the added line, and then set up analysis
mode as needed.
3. Click "Save" to save the settings.
NOTE
 Analysis will be run in the defined mode if the tube rack ID scanned has its
matched order in the system; or else, analysis will be run in the mode of the
default order.
 Deleting an order
To delete an order, select it in the list, and then click “Delete”. The selected item will be
deleted.
NOTE
 The default order cannot be deleted.
 Selecting the instrument to perform QC counts

You can select the instrument to perform QC counts using the switch on the bottom of the
screen. See the figure below as an example.
6-8
If the switches for both Instrument 1 and 2 are on, the QC tube rack will be transported to
both instruments for analysis in turn while running the QC count.
6.3.3 Checking Special Sample Information

When the samples are being processed by the auto sample processing system, you may
need to check the information of the some special samples. Tap the corresponding shortcut
icon on top of the main screen to check the information of not analyzed samples, suspect
samples, and barcode unidentified samples (from left to right).
 Not analyzed samples

You can check the “Sample ID”, sample “Position”, and the “Reason” that the sample was not
analyzed.
 Suspect samples
You can check the “Sample ID”, sample “Position”, time and instrument of the analysis, as
well as the test panel.
6-9
 Barcode unidentified samples

You can check the “Sample ID”, sample “Position”, time and instrument of the analysis, as
well as the test
panel.
6.3.4 Checking the Logs

The log records the key operations performed on the system. It provides the operators an
access to review the operation history and service personnel the facilitation of
troubleshooting.
The system can save 200,000 logs at most. If number of logs exceeds the upper limit, the
oldest log will be overwritten by the latest one. Operators can only view the logs, but cannot
6-10
delete them.
Select or enter the starting and ending dates to view the logs in the specified date range.
6-11
7 Reviewing and Processing Sample
Results
After finishing analysis of a sample, the sample processing line automatically stores results to
the sample processing unit (SPU or the main unit) of the analyzer, and transmits the results to
the data management unit (DMU) in real-time.
Operators may use DMU software to review, report and sort sample results of all analyzers.
For details of the operations, see the Operator's Manual of the analyzers.
7-1
8 Servicing Your System
8.1 Introduction
To ensure the good operating condition of the system, operators shall follow this chapter to
maintain and troubleshoot the system.
 All components and surfaces of the auto sample processing system are
potentially infectious; take proper protective measures for operation or
maintenance.
CAUTION
 Improper maintenance may damage the system. Maintenance procedures
shall be performed as instructed by this Operator's Manual.
 In case of problems not specified in this manual, contact Mindray Customer

Service Department or Mindray specified professionals for assistance.
 Only Mindray-supplied parts can be used for maintenance. Should you have
any problem, contact Mindray Customer Service Department.
NOTE
 This chapter only introduces the servicing operations of the CAL 8000
system. To get servicing information of other units in the sample processing
system, read the Operator's Manuals of the units concerned.
8-1
Servicing Your System
8.2 Cleaning
8.2.1.When, Why and Tools Needs
Procedure When to clean Why to clean Tools needed
Cover sterilization As needed Remove contaminators on Disinfectant (see
the cover 8.2.2Cover Sterilization for
types of disinfectant)
8.2.2.Cover Sterilization
The user shall perform regular cleaning and sterilization to the cover of the system. Use the
specified materials to sterilize the equipment only. For any damage to the instrument or other
accidents caused by using materials other than specified, Mindray will not provide any
warranty.
Mindray does not claim the validity of the listed chemicals in infection control. For effective
control of infection, please consult the Infection Prevention Department of the hospital or the
epidemic professionals.
The sterilization may damage the system to some extent. It is recommended to perform
sterilization only when necessary according to your laboratory protocol. Remember to clean
the equipment before sterilizing.
Recommended disinfectant:70 ％ ethanol,70 ％ isopropyl alcohol, Cidex 2% Glutaral+

Activator.
Prohibited disinfectant: 3% hydrogen peroxide, Aerodesin 2000, Cidex OPA .
8-2
8.3 Replacing
8.3.1 When, Why and Tools Needed
Procedure When to Replace Tools needed
Replacing reagent container As needed /
Replacing waste container When the waste container is /
full.
Replacing the fuse When the fuse blows out /
8.3.2 Replacing Reagent Container or Waste Container
by them are potentially biohazardous. Wear proper personal protective
when handling them in the laboratory.
WARNING
 Remove the waste container cap and replace the waste container only when
the power indicator is not flickering, in order not to make the waste overflow
from the container.
CAUTION
 After replacing the reagent container, check the tubing connected to the cap
assembly and make sure it is not bent over.
After the instruments are connected into the auto sample processing line by CAL 8000, the
reagent containers (except the fluorescent reagents of the analyzer) and the waste
containers are placed in the cabinet of the corresponding track module.
1. Press the sunken area near the top of the cabinet door, and the door will open
outwards,
8-3
CAUTION
 Be aware for pinching while opening or closing the door.
2. Pull out the waste container carriage (left) or the reagent container carriage (right).
3. Replace the waste container or the reagent container as instructed by the operator’s
manual of the corresponding instrument.
8.3.3 Replacing the Fuse

If the fuse of the system is damaged, contact Mindray Customer Service Department or your
local distributor for replacement.
WARNING
 Only install fuses of specified specification.
Specification of the pneumatic unit fuse250V T3A
8-4
9 Troubleshooting
9.1 Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your system.
NOTE
 This chapter is not a complete service manual and is limited to problems
that are readily diagnosed and/or corrected by the user of the system.
9-1
Troubleshooting
9.2 Error Information and Handling

Each of the CAL 8000 loading, unloading and track modules has a reset/mute key. When
there is an error with a module, press the reset/mute key of this module for less than 2
seconds to mute the alarm sound; or press and hold the reset/mute key for 2 seconds or
more to mute the alarm sound and the system will try removing the error automatically.
The possible errors and their troubleshooting information are listed in the following table.
Error Name Help Message

1. Power off the system and restart it after a while.
Voltage abnormal 2. If the error still exists, Contact Mindray Customer
Service Department.
General motor error 2. If the error still exists, Contact Mindray Customer
Service Department.
Invalid instruction 2. If the error still exists, Contact Mindray Customer
Service Department.
Instruction cannot be received
2. If the error still exists, Contact Mindray Customer
and implemented
Service Department.
Errors of the 6800 analyzer or
SM&S are reported
Service Department.
Transfer track area is not
empty when loading
Service Department.
Loading outer track receiving
failed
Service Department.
Loading to inner track loading
storage region failed
Service Department.
Tube rack going through outer
track failed
Service Department.
Outer track terminal is empty 2. If the error still exists, Contact Mindray Customer
Service Department.
Outer track terminal unloading
failed
Service Department.
9-2
Troubleshooting

Multiple unloading failed 2. If the error still exists, Contact Mindray Customer
Service Department.
Loading mechanism
operating failed
Service Department.
Tube rack left in the direction
change position
Service Department.
Unloading mechanism
operating failed
Service Department.
Unloading assembly full 2. If the error still exists, Contact Mindray Customer
Service Department.
Unloading assembly receiving
failed
Service Department.
Loading direction change 1. Power off the system and restart it after a while.
mechanism moving to 2. If the error still exists, Contact Mindray Customer
scanning position failed Service Department.
No tube rack detected when
loading direction change
motor moves to scanning
Service Department.
position
Tube rack direction changing
failed
Service Department.
9-3
10 Data Managing Unit (DMU)
10.1 Overview
Compared with the DMU of stand-alone analyzers, the DMU analyzers in the auto sample
processing line has some special functions to provide necessary supports for the interaction
with the sample processing system and other instruments in the line.
This chapter introduces the special functions of the DMU in the auto sample processing line.
For other general functions, see the operator’s manual of the analyzer.
Data Managing Unit (DMU)
10.2 Reexam Record

A reexam record is a list of samples which have been used to make slides on the slide maker
& stainer. The record contains patient and parameter information for the operator to attain
information about the sample in a convenient way.
You can set to print the reexam record automatically or print manually at the review or report
screen of the DMU.
10.2.1 Print Setup
You can enable/disable the automatic record printing, and select the desired patient
information and parameters to be included in the reexamine record.
 Enable/Disable autoprint
Select “On”/”Off” to enable/disable the automatic record printing function.
 Set the threshold of items for auto print

Enter or click the arrows in the “Threshold of Items for Auto Print” field to define the threshold.
After the entry is saved and the autoprint function is enabled, when the number of samples
processed by the slide maker & stainer reaches this threshold, the system automatically
prints the reexam record of these samples.
10-2
 Select patient information
1. Click the “Select Patient Info.” button, and the dialog below pops up.
2. Select the patient information items you want to be included in the reexam record.
3. Click “OK” to save and exit.
 Select the parameters to print
1. Click the “Select Para. to Print” button, and the dialog below pops up.
10-3
2. Select the parameters the result of which you want to be included in the reexam
record.
3. Click “OK” to save and exit.
10.2.2 Reexam Record Printing Status

In the “Review” and “Report” screens of the DMU for auto sample processing line, there is a
“Reexam Record Printing Status” column showing whether the reexam record of the sample
is printed.
10.2.3 Manual Printing the Reexam Record

If the auto print function of the reexam record is not enabled, you can print the record
manually at the “Review” or “Report” screen.
1. Click “Print Reexam Record”, and the dialog box below pops up.
10-4
2. Select “Samples with Unprinted Reexam Record of the Day” or “Selected Records” as
needed.
3. Click “OK” to exit and start printing.
10-5
10.3 Acquire patient info. from LIS after the sample ID

Editing
For the DMU of the sample processing line, there is a checkbox “Acquire patient info. from
LIS after the sample ID is edited”. If this check box is selected, once the patient ID is edited,
the system will automatically acquire the patient information from LIS using the new ID.
10-6
10.4 Serial No. in LIS

For the convenience of the user to match the samples in the DMU to samples in LIS, there is
a “Serial No.” column in the “Review” and “Report” screens of the DMU for auto sample
processing line.
10-7
10.5 Sample Traceability

The sample traceability function enables the users to trace the matching between samples
and the information of reagents used for its analysis/corresponding QC information, as well
as the matching between the QC results and the reagents used for the analysis.
10.5.1 Tracing the Information of A Certain Sample

Click the “View” button at the “Report” screen, and then click “QC”/“Reagent” in the menu to
display the corresponding tab.
 Checking the QC information of selected sample
In this tab, you can check the in-use QC information at L-J setup screen corresponding to the
selected sample, and the time and operator of the latest QC analysis.
10-8
 Checking the reagent information of selected sample
In this tab, you can check the information of the reagents used for the analysis of the selected
sample. For open-reagent models, if the user does not input the reagent information after
replacing a new container, the information here will be null.
10.5.2 Tracing Samples Corresponding to Specified Batch of
Reagent/Control
 Tracing samples corresponding to the specified batch of reagent
1. In “Review” screen, click the button, and the dialog box

below pops up.
2. 1) Select the “Reagent” radio button;
2) Select desired reagent name in the “Reagent” pull-down list;
3) Specify the desired “Lot No.” of the reagent.
3. Click “OK” to close the dialog box, and the software will search for matching samples
and display them in the table area.
 Tracing samples corresponding to the specified batch of control
1. In “Review” screen, click the button, and the “Sample

Traceability” dialog box pops up.
10-9
2. 1) Select the “QC” radio button.
2) Specify the desired “Lot No.” of the control.
3. Click “OK” to close the dialog box, and the software will search for matching samples
and display them in the table area.
10.5.3 Tracing Reagent Information Used for Control Analysis

In L-J QC Table screen, click “Reagent”, and the dialog box below pops up.
The dialog box shows the information of all reagents used in the selected L-J QC analysis.
10-10
11 Supplementary Reagent Loading
(SRL) Module (Optional)
11.1 Overview
The Supplementary Reagent Loading Module (hereinafter called SRL or SRL module) is an
optional module which stores a fixed volume of each reagent. When the error of no reagent is
reported, if a SRL module is configured, it will support the analyzer to keep running until the
reagent inside the SRL module is used up, during which process the operator need to replace
the reagent container.
11-1
Supplementary Reagent Loading (SRL) Module (Optional)
11.2 Structure and Interfaces
1 --- Indicator 2 --- Power switch

3 --- Reserved interface 4 --- Pneumatic unit control interface
5 --- Reagent outlets 6 --- Pneumatic unit interface (vacuum)
7 --- Reagent inlets
 Pneumatic unit control interface

Provide the connection to the pneumatic unit control interface on the main unit of the
analyzer.
After the SRL module is configured, the cable of pneumatic unit control interface will be
changed into a 2-way cable, which is connected to both the pneumatic unit of the analyzer
and the SRL module.
 Reagent outlets
Provide the connection to the reagent interfaces on the main unit of the analyzer. There are
printings showing the corresponding reagent names, and the interfaces are color-coded in
the same way as the cable connectors.
 Pneumatic unit interface (vacuum)
11-2
Provide the connection to the pneumatic unit of CAL8000.
 Reagent inlets
Provide the connection to the reagent containers. There are printings showing the
corresponding reagent names, and the interfaces are color-coded in the same way as the
cable connectors.
11-3
11.3 Checking the Pressure of the SRL Module

When the SRL module is configured, tap "Menu" > "Status" > "Temp.&Pressure" to go to the
"Temp.&Pressure" screen, where the operator can check the vacuum pressure of "SRL
Cistern (VAC)" And the normal range.
11-4
11.4 Errors Related to the SRL Module

The table below lists the errors might be reported after the SRL module is configured and the
corresponding help messages.
Error Name Help Message
0x00006029 1. Shut down the analyzer power and SRL module power directly,
SRL Serial port and restart them later.
Communication error 2. If the error still exists, contact our customer service department.
0x00003040 1. SRL module pressure out of range. Sample analysis may be
SRL module pressure disabled.
out of range 2. Tap the "Remove Error" button to remove this error.
3. If the error still exists, contact our customer service department.
0x00003042 1. SRL module vacuum out of range. Sample analysis may be
SRL module vacuum out disabled.
of range 2. Tap the "Remove Error" button to remove this error.
3. If the error still exists, contact our customer service department.
0x00004319 1. Buffer cistern of supplementary reagent loading module
Buffer cistern of abnormal. Sample analysis may be disabled.
supplementary reagent 2. Error cannot be removed. Please contact our customer service
loading module department.
abnormal
11-5
A Glossary
 CMU
Control and management module of the Auto Sample Processing System. It monitors the
modules and devices of the sample processing line, tracks sample flow, sets up orders and
views samples that have not been analyzed.
 DMU
Data management unit of Auto Hematology Analyzer, also called the PC. It runs data
management operations, including worklist editing, analysis results reviewing, analysis report
generating, and LIS/HIS communication.
 SPU
Sample processing unit of Auto Hematology Analyzer, also called the main unit. Process
patient samples and sends original test results to DMU.
 Analyzer
Short for Auto Hematology Analyzer, which analyzes blood or body fluid samples, providing
sample cells analysis results.
 Order
The source of sample analyzing mode in Auto Sample Processing System, which can be set
up in CMU software.
 Track Unit
It receives sample racks sent by the loading module, transports them to the analyzer for
analysis, or to the SM&S for slide making and staining, and then transports the processed
sample racks to the unloading storage region of the track module.
 Track Module
Track unit and its cabinet.
 Pneumatic Unit
Also called compressor or PU. It provides pressure and vacuum to SPU of the analyzer or the
Auto Sample Processing System.
 SM&S
Short for Auto Slide Maker & Stainer, which makes sample slides.
 Unloading Module
unloading unit and its cabinet.
 Unloading Assembly
It receives sample tube racks that have been processed from the unloading storage region of
the track module, so that users may collect them.
 Loading Module
Loading unit and its cabinet.
 Loading Assembly
It accommodates sample tube racks, reads barcodes of tube racks by barcode scanner and
sends the racks to specified track module.
A-1
B Specifications
B.1 Classification
According to the CE classification, the CAL 8000 Auto Processing System belongs to In vitro
diagnostic medical devices other than those covered by Annex II.
B.2 Ports
 2 network ports
 1 pneumatic unit control port
B.3 Tubes
Sizes of tubes supported:11-13mm(outer diameter)×65-78mm/80-83mm(without cap/with cap)
B.4 Power Supply

Voltage Frequency Power
Loading Module 100V-240V~ 50/60Hz 100VA
Unloading Module 100V-240V~ 50/60Hz 100VA
Nonterminal Analyzer 100V-240V~ 50/60Hz 100VA

Track Module
Nonterminal SM&S 100V-240V~ 50/60Hz 100VA

Track Module
Terminal Track 100V-240V~ 50/60Hz 100VA

Module
Compressor a.c. 110V/115V ±10% 60Hz ±2Hz 600VA
a.c. 220V/230V ±10% 50Hz ±2Hz 450VA
60Hz ±2Hz 300VA
B.5 Sound Pressure

Maximal sound pressure: 85dBA
B-1
Specifications
B.6 Operating Environment

 Ambient temperature: 15℃～32℃
 Optimal operating humidity: 30%～85%
 Atmospheric pressure: 70kPa～106kPa
B.7 Storage Environment

 Ambient temperature: -10℃～40℃
 Relative humidity: 10%～90%
B.8 Running Environment

 Ambient temperature: 5℃～40℃
 Relative humidity: 10%～90%
NOTE
 Only store and use this system in specified environmental conditions.
B.9 Dimensions and Weight
Height
Depth
Width
B-2
Specifications
Width (mm) Height Depth (mm) Weight (Kg)

(mm)
CAL 8000 (without Varies with ≤1470 ≤1030 Varies with
pneumatic unit) specific specific
configurations configurations
Pneumatic Unit ≤310 ≤480 ≤430 ≤20
Nonterminal analyzer track ≤1190 ≤880 ≤1030 ≤260

module
Nonterminal SM&S track ≤1350 ≤880 ≤1030 ≤350

module
Terminal track module ≤1390 ≤880 ≤1030 ≤350
Loading Module ≤350 ≤970 ≤1030 ≤70
Unloading Module ≤340 ≤970 ≤1030 ≤60
B.10 Contraindication
None
B.11 Barcode Specifications

The Sample Processing System can read barcodes that are stuck to the test tubes. The
sample ID read from the barcode will be stored and used as the only identification of the
sample.
The barcodes used shall meet the specifications stated in this section.
1. Supported barcode types
All code types and check digit supported by the system are listed as follows.
Barcodes Supported by the Sample Processing System
Code Type Check Digit Number of Digits
Self-checking (check digit is

CODE128 No more than 20 digits (sample ID)
always included)
CODE93 No more than 20 digits (sample ID)
always included)
UPC/EAN Fixed length: 8 or 13 digits
always included)
B-3
Specifications
Not use check digit No more than 20 digits (sample ID)

ITF
No more than 19 digits (sample ID)+1 digit (check digit) =
Use check digit
no more than 20 digits

CODE39
No more than 19 digits (sample ID)+1 digit (check digit) =
Use check digit
no more than 20 digits

CODABAR
No more than 19 digits (sample ID)+1 digit (check
Use Check digit
digit) = no more than 20 digits
NOTE
 The manufacturer suggests you use check digit to reduce the possibility of
misreading.
2. Barcode label dimensions
Barcode height: A≥10mm

Label width: B≤45mm
Clear area width: C≥5mm
Wide-to-narrow ratio: between 2.5: 1 and 3.0: 1

Width of the narrowest bar: above 0.127mm
Code quality: According to ANSI MH10.8M standard, the code quality shall be Level C or
above.
3. Samples of valid and invalid barcode labels:

Use of invalid barcode labels shown in the following figures will increase the possibility of
misreading. To ensure good readability, use valid labels.
B-4
Specifications
B-5
Specifications
B.12 EMC Description

 Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
 This equipment complies with the emission and immunity requirements of the EN
61326-1:2006 and EN 61326-2-6:2006.
 This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
NOTE
 It is the manufacturer's responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
 It is the user's responsibility to ensure that a compatible electromagnetic

environment for the equipment can be maintained in order that the device
will perform as intended.
B.13 Safety Classification

Level of transient overvoltage: Category II.
Rated pollution degree: 2.
B.14 Input/Output Devices
NOTE
 Be sure to use the specified devices only.
B.14.1 External Computer

 CPU: Intel(R) i5 or above
 RAM: 4GB or above
 USB interface: more than 4 interfaces
 Network adapter: 2 or more adapters
 Hard disk: 500GB or above
 Operating system: Microsoft Windows 8 64bit
 Support LAN waking function, and powering on from network
 Support VGA, DP display interface
B-6
Specifications
 Size: length<465mm, width<190mm, height<25mm
B.14.2 Printer (Optional)
B.14.3 USB Flash Disk
B-7
C Index
Basic assemblies and modules Operating Your System, 5-1
control and data management module Order Setup, 6-7, 6-10
(CMU), 2-20 Preparation of tubes and tube racks, 4-3
loading module, 2-5 Replacing, 8-3
track module, 2-9 Replacing Reagent Container/Package,
unloading module, 2-16 8-3
Basic Assemblies and Modules, 2-3 Replacing the Fuse, 8-4
accessories, 2-21 Reviewing and Processing Sample Results,
Cleaning, 8-2 7-1
cover sterilization, 8-2 Safety Information, 1-4
Daily operation Sample Preparation, 4-3
checks before starting the system, 5-2 Servicing Your System, 8-1
daily operating process, 5-1 Specifications, B-1
finishing analysis, 5-5 SRL Module, 11-1
start up the system, 5-3 Supplementary Reagent Loading Module,
starting analysis, 5-4 11-1
EMC, B-6 System Configuration, 2-2
General Environment, 3-3 System Function, 2-23
Moving and Installing the System, 3-4 Troubleshooting, 9-1
Notes during analysis, 5-6, 5-7, 5-8, 5-9
C-1
P/N: 046-005587-00 (5.0)

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CAL 8000 Auto Sample Processing System

Intellectual Property Statement

Mindray intends to maintain the contents of this manual as confidential information.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

, are the trademarks, registered or otherwise, of Mindray in

Responsibility on the Manufacturer Party

 the product is used in accordance with the instructions for use.

 This equipment must be operated by skilled/trained clinical professionals.

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.

 Malfunction or damage caused by unstable or out-of-range power input.

 Malfunction or damage caused by force majeure such as fire and earthquake.

 Malfunction or damage caused by improper operation or repair by unqualified or

 Others not caused by instrument or part itself.

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestraβe 80, Hamburg 20537, Germany

7 Reviewing and Processing Sample Results ..................................................... 7-1

B.14.3 USB Flash Disk ........................................................................................... B-7

1.2 Who Should Read This Manual

 perform daily operating tasks.

 perform system maintenance and troubleshooting.

1.3 How to Find Information

If you want to … See …

1.4 Safety Information

When you see… Meaning

read the statement below the symbol. The statement is

1.4.1 Protection from Biohazards

1.4.2 Protection from Other Hazards

 Make sure all the safety measurements are adopted. It is prohibited to

1.4.3 Using the System

 Power off the system before connecting it to external devices (e.g.,

 Please take action to any alarm and error messages immediately.

 It is recommended that you install anti-virus software on the computer and

1.4.4 Maintaining the System

 Be careful when opening/closing and removing/installing the doors, covers

 Please use the system strictly as instructed by this manual.

1.4.5 Using Reagents

 Let reagents equilibrate at room temperature for a while before using.

1.4.6 Disposing of Waste

 Be sure to dispose of reagents, waste, samples, consumables, etc.

read the statement below the symbol. The statement is

You may find the following symbols of the system:

When you see… Meaning

CAUTION, CONSULT ACCOMPANYING

PROTECTIVE EARTH (GROUND)

FOR IN VITRO DIAGNOSTIC USE

ATMOSPHERIC PRESSURE LIMITATION

THE FOLLOWING DEFINITION OF THE

AUTHORISED REPRESENTATIVE IN THE

THE DEVICE IS FULLY CONFORMANCE

Type Label Connotation Location

Power WARNING 1. Next to the power inlet of

Type Label Connotation Location

Transfer To avoid injury, do not put your 1. On top right of the

Type Label Connotation Location

Type Label Connotation Location