BC-5380 Auto Hematology Analyzer

Service Manual
 Copyright

© 2008 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Service Manual, the issued Date is 2008-12 (Version: 1.0).

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 copyrights or patents and does not convey any license under
the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability
arising out of any infringements of patents or other rights of third parties.

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, rent, adaption and translation of this manual
in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, are the registered trademarks or trademarks owned by Mindray in China and

other countries. All other trademarks that appear in this manual are used only for editorial
purposes without the intention of improperly using them. 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 safety, reliability and performance of this product only in the
condition that:

„ all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;

I
„ 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.

z This equipment must be operated by skilled/trained medical professionals.

z 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.

z Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.

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:

„ any Mindray product which has been subjected to misuse, negligence or accident;

„ any Mindray product from which Mindray's original serial number tag or product
identification markings have been altered or removed;

„ any product of any other manufacturer.

Return Policy

Return Procedure

In the event that it becomes necessary to return this product or part of this product to Mindray,
the following procedure should be followed:

1. Obtain return authorization: Contact the Mindray Service Department and obtain a
Customer Service Authorization (Mindray) number. The Mindray number must appear on
the outside of the shipping container. Returned shipments will not be accepted if the
Mindray number is not clearly visible. Please provide the model number, serial number,
and a brief description of the reason for return;

2. Freight policy: The customer is responsible for freight charges when this product is
shipped to Mindray for service (this includes customs charges);

3. Return address: Please send the part(s) or equipment to the address offered by Customer
Service department.

III
Company Contact

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

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,

Address:
Nanshan,ShenZhen 518057, P.R.China,

Phone: +86 755 26582479 26582888

Fax: +86 755 26582934 26582500

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 Conventions Used in This Manual......................................................................... 1-4
1.5 Symbols ................................................................................................................. 1-5

2 System Structure................................................................................................. 2-1

2.1 Introduction............................................................................................................ 2-1
2.2 Fluidic System ....................................................................................................... 2-2
2.3 Hardware System .................................................................................................. 2-3
2.4 Main Structure ....................................................................................................... 2-4
2.5 Software structure ............................................................................................... 2-11
2.5.1 Menu structure ....................................................................................... 2-11
2.5.2 Passwords.............................................................................................. 2-31

3 Instrument Installation and Software Upgrade................................................. 3-1

3.1 Preparations .......................................................................................................... 3-1
3.1.1 Purpose .................................................................................................... 3-1
3.1.2 Tools ......................................................................................................... 3-1
3.1.3 Accessories .............................................................................................. 3-1
3.2 Installation Requirements ...................................................................................... 3-2
3.2.1 Space Requirements ................................................................................ 3-2
3.2.2 Power Requirements................................................................................ 3-2
3.2.3 Environment Requirements...................................................................... 3-2
3.2.4 PC Configuration Requirements .............................................................. 3-3
3.3 Package Checking and Unpacking ....................................................................... 3-7
3.3.1 Checks before unpacking......................................................................... 3-7
3.3.2 Unpacking the main unit........................................................................... 3-7
3.3.3 Checking packing list................................................................................ 3-9
3.4 Removal and Installation ..................................................................................... 3-10
3.5 Connections......................................................................................................... 3-23
3.6 Start-up ................................................................................................................ 3-27
3.6.1 Inspection before Startup ....................................................................... 3-27
3.7 Setup and Adjustment ......................................................................................... 3-35
3.8 Testing Other Functions....................................................................................... 3-41
3.9 Confirming Gain................................................................................................... 3-42
3.10 Calibration and Performance Test ....................................................................... 3-47
3.11 Software upgrade ................................................................................................ 3-53

4 Fluidic System ..................................................................................................... 4-1

4.1 Introduction of Fluidic Parts ................................................................................... 4-1
4.1.1 Piercing needle......................................................................................... 4-1
4.1.2 Probe Wipe............................................................................................... 4-1

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 Table of Contents

4.1.3 Pumps ...................................................................................................... 4-1

4.1.4 Syringes ................................................................................................... 4-1
4.1.5 Valves ....................................................................................................... 4-1
4.1.6 Baths ........................................................................................................ 4-1
4.1.7 Volumetric tube......................................................................................... 4-2
4.1.8 Filters........................................................................................................ 4-2
4.2 Fluidic System ....................................................................................................... 4-3
4.2.1 Reagent volume required......................................................................... 4-3
4.2.2 Fluidic System Drawing............................................................................ 4-5
4.2.3 WBC Measurement Procedures .............................................................. 4-6
4.2.4 RBC/PLT Measurement Procedures........................................................ 4-6
4.2.5 HGB Measurement Procedures ............................................................... 4-7
4.3 Sequence of Whole Blood CBC+DIFF Measurement ........................................... 4-8
4.3.1 Sampling and dispensing procedures ...................................................... 4-8
4.3.2 DIFF Channel ......................................................................................... 4-10
4.3.3 WBC/HGB Channel................................................................................ 4-13
4.3.4 RBC/PLT Channel .................................................................................. 4-15
4.3.5 Sequence of Predilute Mode CBC+DIFF Measurement........................ 4-18
4.3.6 Sequence of CBC Measurement ........................................................... 4-18

5 Hardware System ................................................................................................ 5-1

5.1 Mother board ......................................................................................................... 5-3
5.1.1 Introduction............................................................................................... 5-3
5.1.2 Board Composition................................................................................... 5-3
5.1.3 Adjustment and Test Points.................................................................... 5-26
5.1.4 Removal ................................................................................................. 5-28
5.1.5 Troubleshooting...................................................................................... 5-30
5.2 Data board ........................................................................................................... 5-32
5.2.1 Introduction............................................................................................. 5-32
5.2.2 Board composition.................................................................................. 5-32
5.2.3 Adjustment and Test Points.................................................................... 5-45
5.2.4 Disassembly and assembly method....................................................... 5-49
5.2.5 Troubleshooting...................................................................................... 5-51
5.3 Drive board .......................................................................................................... 5-59
5.3.1 Introduction............................................................................................. 5-59
5.3.2 Board composition.................................................................................. 5-59
5.3.3 Adjustment and Test Points.................................................................... 5-75
5.3.4 Disassembly and assembly method....................................................... 5-78
5.3.5 Troubleshooting...................................................................................... 5-80
5.4 Autoloader board ................................................................................................. 5-99
5.4.1 Introduction............................................................................................. 5-99
5.4.2 Board Composition................................................................................. 5-99
5.4.3 Adjustment and Test Points.................................................................. 5-109
5.4.4 Disassembly and assembly method..................................................... 5-110
5.4.5 Troubleshooting.................................................................................... 5-112
5.5 Power board ...................................................................................................... 5-117
5.5.1 Introduction........................................................................................... 5-117
5.5.2 Board Composition............................................................................... 5-117
5.5.3 Adjustment and Test Points.................................................................. 5-122
5.5.4 Replacement and Connection.............................................................. 5-124
5.5.5 Troubleshooting.................................................................................... 5-127
5.6 Volumetric and pressure detecting board.......................................................... 5-129
5.6.1 Introduction........................................................................................... 5-129
5.6.2 Board Composition............................................................................... 5-129
5.6.3 Disassembly and assembly method..................................................... 5-132
5.6.4 Troubleshooting.................................................................................... 5-134

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 Table of Contents

5.7 Liquid-level detecting board .............................................................................. 5-140

5.7.1 Introduction........................................................................................... 5-140
5.7.2 Board composition................................................................................ 5-140
5.7.3 Replacement and Connection.............................................................. 5-143
5.7.4 Troubleshooting.................................................................................... 5-145
5.8 Laser Control Board .......................................................................................... 5-148
5.8.1 Introduction........................................................................................... 5-148
5.8.2 Board Composition............................................................................... 5-148
5.8.3 Adjustment and Test Points.................................................................. 5-150
5.8.4 Assembly and disassembly.................................................................. 5-151
5.8.5 Troubleshooting.................................................................................... 5-151
5.9 Pre-amplification board...................................................................................... 5-154
5.9.1 Introduction........................................................................................... 5-154
5.9.2 Board Composition............................................................................... 5-154
5.9.3 Adjustment and Test Points.................................................................. 5-158
5.9.4 Disassembly and assembly.................................................................. 5-158
5.9.5 Troubleshooting.................................................................................... 5-158
5.10 Indicator Board .................................................................................................. 5-160
5.10.1 Introduction........................................................................................... 5-160
5.10.2 Board Composition............................................................................... 5-160
5.10.3 Disassembly and assembly method..................................................... 5-161
5.10.4 Troubleshooting.................................................................................... 5-162
5.11 Key Board .......................................................................................................... 5-163
5.11.1 Introduction........................................................................................... 5-163
5.11.2 Board Composition............................................................................... 5-163
5.11.3 Disassembly and assembly method..................................................... 5-164
5.11.4 Troubleshooting.................................................................................... 5-165

6 Maintenance......................................................................................................... 6-1
6.1 Maintenance Modules and the Corresponding Settings ....................................... 6-1
6.2 General .................................................................................................................. 6-3
6.3 Disassembling the Panels ..................................................................................... 6-4
6.3.1 Removing the left door ............................................................................. 6-4
6.3.2 Removing the right door........................................................................... 6-5
6.3.3 Removing the top cover ........................................................................... 6-6
6.3.4 Removing the back panel......................................................................... 6-7
6.3.5 Removing the front door........................................................................... 6-8
6.3.6 Removing the front cover assembly......................................................... 6-9
6.4 Replacing the Valves, Pumps and Syringes........................................................ 6-11
6.4.1 Replacing valves .................................................................................... 6-13
6.4.2 Replacing the Pressure Chamber .......................................................... 6-15
6.4.3 Replacing the Vacuum Chamber ........................................................... 6-17
6.4.4 Replacing the Syringe Assembly............................................................ 6-18
6.4.5 Replacing the Waste Pump.................................................................... 6-24
6.5 Replacing the Bath/Aperture Assembly............................................................... 6-26
6.6 Replacing the Sampling Module and Adjusting Position ..................................... 6-29
6.6.1 Replacing the Sample Probe and Wipe ................................................. 6-29
6.6.2 Replacing the Optical Sensor................................................................. 6-31
6.6.3 Removing the Sampling Module ............................................................ 6-33
6.7 Maintaining and Replacing the DIFF Reaction Bath ........................................... 6-37
6.8 Autoloader Assembly (Closed-Tube)................................................................... 6-39
6.8.1 Removing and replacing the closed-tube sample compartment assembly
6-39
6.8.2 Removing and replacing the detection switches of the sample transport unit

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 Table of Contents

6-45
6.8.3 Replacing the sample transport unit....................................................... 6-46
6.9 Mix mechanism.................................................................................................... 6-58
6.10 Adjustment........................................................................................................... 6-66
6.10.1 Adjusting Sample Probe Position........................................................... 6-66
6.10.2 Adjusting Pincher Position ..................................................................... 6-73

7 Optical System..................................................................................................... 7-1

7.1 Optical System Adjustment and Troubleshooting.................................................. 7-1
7.2 Removing and Installing Optical System Assemblies............................................ 7-3
7.2.1 Laser driver board .................................................................................... 7-3
7.2.2 Front light assembly ................................................................................. 7-4
7.2.3 Flow cell assembly ................................................................................... 7-5
7.2.4 Rear light collimator assembly ................................................................. 7-7
7.2.5 Beam splitter assembly ............................................................................ 7-7
7.2.6 Rear light collector assembly ................................................................... 7-8
7.2.7 Rear light detector assembly.................................................................. 7-10
7.3 Adjustment........................................................................................................... 7-12
7.3.1 Coarse adjustment ................................................................................. 7-12
7.3.2 Preparation before fine tuning................................................................ 7-18
7.3.3 Fine tuning.............................................................................................. 7-19
7.3.4 Gain setup .............................................................................................. 7-24
7.4 Troubleshooting ................................................................................................... 7-27
7.4.1 Laser spot-deviation ............................................................................... 7-27
7.4.2 Flow cell clog.......................................................................................... 7-27
7.4.3 Dirty flow cell .......................................................................................... 7-28

8 Troubleshooting .................................................................................................. 8-1

8.1 Error code and information .................................................................................... 8-1
8.2 Errors indicated by error messages ...................................................................... 8-9
8.2.1 Pressure errors......................................................................................... 8-9
8.2.2 Reagent errors ......................................................................................... 8-9
8.2.3 Hardware errors ..................................................................................... 8-10
8.2.4 Measurement errors............................................................................... 8-10
8.2.5 Temperature errors................................................................................. 8-12
8.2.6 Scattergram errors ................................................................................. 8-13

9 Appendixes ......................................................................................................... A-1

A. Accessories ...........................................................................................................A-1
B. List of Wearing Parts .............................................................................................B-1
C. Fluidic diagram ..................................................................................................... C-1
D. Pump and Valve Function Table ........................................................................... D-1
E. Tubing....................................................................................................................E-1
F. Method to identify cross network cable and direct-connected network cable ....... F-1

4
 1 Using This Manual
1.1 Introduction

The chapter explains how to use the BC-5380 service manual. This manual provides the
reference information and procedures needed in servicing the BC-5380. Before servicing the
BC-5380, read and understand the manual carefully for servicing the equipment properly and
for your safety.

This manual is to be used in conjunction with the operator’s manual of BC-5380.It does not
contain information and procedures already covered in the operator’s manual of BC-5380.

z Be sure to operate and service the analyzer strictly as instructed in this

manual and the operator’s manual.

1-1
 Using This Manual

1.2 Who Should Read This Manual

To use this service manual effectively, the reader should posses:

A thorough understanding of

„ Basic electronic and fluidics principles and devices

„ Reagent systems

„ Quality control

„ Troubleshooting concepts

The ability to

„ Use basic mechanical tools and understand related terminology

„ Use a digital voltmeter (DVM) and an oscilloscope

„ Read fluidics schematics and understand related terminology

„ Read electronic schematics and understand related terminology

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 Using This Manual

1.3 How to Find Information

This service manual comprises 8 chapters and 5 appendices. Refer to the table below to find
the information you need.

If you want to … See …

learn about the system structure and the basic Chapter 2 System Structure
principle of the BC-5380
learn about the installation requirements and how to Chapter 3 System Installation and
upgrade the BC-5380 software Software Upgrade
learn about the fluidic system of the BC-5380 Chapter 4 Fluidic System
learn about the hardware system of the BC-5380 Chapter 5 Hardware System
learn about how to maintain the BC-5380 Chapter 6 Maintenance
learn about the optical system of the BC-5380 Chapter 7 Optical System
learn about how to troubleshoot the common errors Chapter 8 Troubleshooting
of the BC-5380
learn about the main spare parts of the BC-5380 Appendix A Accessories
learn about the main wearing parts of the BC-5380 Appendix B List of Wearing Parts
learn about the schematic diagram of the fluidic Appendix C Fluidic Diagram
system of the BC-5380
learn about the function of each valve and pump of Appendix D Pump and Valve Function
the BC-5380 Table
learn about the tubing connection of the BC-5380 Appendix E Tubing
learn about how to identify cross network cable and Appendix F Method to Identify Cross
direct-connected network cable Network Cable and Direct-Connected
Network Cable

1-3
 Using This Manual

1.4 Conventions Used in This Manual

This manual uses certain typographical conventions to clarify meaning in the text:

„ all capital letters enclosed in [ ] indicate a key name (on the external keyboard), such as
[ENTER].

„ bold letters included in “ ” indicate text you can find on the screen, such as “Clean”.

„ bold letters indicate chapter titles, such as Chapter 1 Using This Manual.

All illustrations in this manual are provided as examples only. They may not necessarily reflect
your analyzer setup or data displayed.

1-4
 Using This Manual

1.5 Symbols

You will find the following symbols in this manual:

When you see… Then…

read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
read the statement below the symbol. The statement is
alerting you to a possibility of analyzer damage or
unreliable analysis results.
read the statement below the symbol. The statement is
alerting you to information that requires your attention.

read the statement below the symbol. The statement is

alerting you to a potentially biohazardous condition.

You may find the following symbols on the analyzer, reagents, controls or calibrators.

When you see… It means…

CAUTION, CONSULT ACCOMPANYING

DOCUMENTS.

BIOLOGICAL RISK

HIGH VOLTAGE

WARNING, LASER BEAM

WARNING, HOT SURFACE

PROTECTIVE EARTH (GROUND)

1-5
Using This Manual

EARTH (GROUND)

ALTERNATING CURRENT

FOR IN VITRO DIAGNOSTIC USE

BATCH CODE

USE BY

SERIAL NUMBER

CATALOG NUMBER (FOR CONTROLS)

USE BY (YYYY-MM-DD) (FOR

CONTROLS)

DATE OF MANUFACTURE

MANUFACTURER

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

IRRITATING SUBSTANCE

THE FOLLOWING DEFINITION OF THE

WEEE LABEL APPLIES TO EU MEMBER
STATES ONLY: THE USE OF THIS

1-6
 Using This Manual

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.

Be sure to observe the following precautions for the safety of patients, operators and yours
when you are servicing the analyzer.

1-7
 Using This Manual

z 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.

z Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g.

ethanol) around the analyzer. Otherwise, the risk of explosion may exist.

z Contacting exposed electronic components while the equipment is attached

to power can cause personal injury from electric shock or damage to
electronic components. Power down before removing covers to access
electronic components.

z Connect the analyzer to a socket having sole fuse and protective switch. Do
not use the same fuse and protective switch with other equipment (e.g. life
supporting equipment). Otherwise, the equipment failure, over current or
impulse current that occurs at the startup moment may lead to tripping.

z To prevent personal injury during the maintenance, keep your clothes, hairs
and hands from the moving parts, such as sample probe, clipper and
piercer.

z Possible mechanical movement of the warned position may lead to personal

injury during the normal operation, removal and maintenance.

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

according to government regulations.

z The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

z If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

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 Using This Manual

z Improper maintenance may damage the analyzer. Maintain the analyzer

strictly as instructed by the service manual and inspect the analyzer
carefully after the maintenance.

z For problems not mentioned in the service manual, contact Mindray

customer service department for maintenance advice.

z To prevent personal injury or damage to equipment components, remove

metal jewelry before maintaining or servicing electronic components of the
equipment.

z Electrostatic discharge may damage electronic components. If there is a

possibility of ESD damage with a procedure, then do that procedure at an
ESD workstation, or wear an antistatic wrist strap.

z This equipment must be operated by skilled/trained medical professionals.

z Samples, controls, calibrators and waste are potentially infectious. Wear

proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

z All the analyzer components and surfaces are potentially infectious.

z Take proper protective measures for operation or maintenance.

z The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

1-9