Mindray CAL 8000 User manual

CAL 8000 Auto Sample Processing System
Operator’s Manual

I
© 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.

II
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.

III
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.

IV
Customer Service Department
EC-Representative:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestraβe 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
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:
[e-mail]
Tel:
[phone]
Fax:
[phone]

1
Table of Contents
1Using 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
2Understanding 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
3Installing 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
4Preparations 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
5Operating 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
6Operating 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

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2
7Reviewing and Processing Sample Results.....................................................7-1
8Servicing Your System........................................................................................8-1
8.1 Introduction............................................................................................................8-1
8.2 Cleaning.................................................................................................................8-2
8.3 Replacing...............................................................................................................8-3
9Troubleshooting ..................................................................................................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
AGlossary ...............................................................................................................A-1
BSpecifications ......................................................................................................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

Table of Contents
3
B.14.3 USB Flash Disk...........................................................................................B-7
CIndex .....................................................................................................................C-1

1-1
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.

Using This Manual
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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.

Using This Manual
1-3
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
assemblies and modules, system functions, software
interfaces and operations of the CAL 8000
2 Understanding the CAL 8000
System
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
processing of the CAL 8000
5 Operating Your System
learn about the operations of the control and management
module of the CAL 8000
6 Operating the Control and
Management Module (CMU)
learn about the way to review and process analysis results of
the CAL 8000
7 Reviewing and Processing
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
connected to the CAL 8000
10 Data Managing Unit (DMU)
learn about the composition and functions of the
supplementary reagent loading module of the CAL 8000
11 Supplementary Reagent
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

Using This Manual
1-4
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
read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
CAUTION
read the statement below the symbol. The statement is
alerting you to a possibility of system damage or unreliable
analysis results.
NOTE
read the statement below the symbol. The statement is
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.

Using This Manual
1-5
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

Using This Manual
1-6
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.

Using This Manual
1-7
1.5 Symbols
You will find the following symbols in this manual:
When you see…
Meaning
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
WARNING
read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
CAUTION
read the statement below the symbol. The statement is
alerting you to a possibility of system damage or unreliable
analysis results.
NOTE
read the statement below the symbol. The statement is
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.
When you see…
Meaning
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

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1-8
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.

Using This Manual
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Type
Label
Connotation
Location
Power
Warning
WARNING
1. CONNECT ONLY TO A
PROPERLY EARTH
GROUNDED 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. Next to the power inlet of
the loading unit
2. Next to the power inlet of
the unloading unit
3. Next to the power inlet of
each track module
4. Next to the electric panel of
every cabinet

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Type
Label
Connotation
Location
Transfer
track
movement
warning
To avoid injury, do not put your
hands between the interior and
exterior transfer tracks when the
system is in operation!
1. On top right of the
nonterminal analyzer track
cover, next to the transfer
track
2. On top left and right of the
nonterminal analyzer track
cover, next to the transfer
track
3. On top right of the
nonterminal SM&S track
cover, next to the transfer
track
4. On top left and right of the
nonterminal SM&S track
cover, next to the transfer
track