Mindray CAL 8000 User manual

CAL 8000 Auto Sample Processing System
Operator’s Manual

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© 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.

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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.

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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]

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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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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

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B.14.3 USB Flash Disk...........................................................................................B-7
CIndex .....................................................................................................................C-1