New 3-DIFF Hematology Analyzer Service Manual - V7.0

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New 3-DIFF

(AUTO) HEMATOLOGY ANALYZER

SERVICE MANUAL
© 2012-2019 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2019-12.

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.

WARNING
 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 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.

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

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.

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: [email protected]
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

II
Table of Contents
1 Using This Manual ............................................................................................................. 1-1
1.1 Overview ................................................................................................................ 1-1
1.2 Who Should Read This Manual ............................................................................. 1-2
1.3 Using This Manual ................................................................................................. 1-2
1.4 Conventions Used in This Manual ......................................................................... 1-3
1.5 Safety Information ................................................................................................. 1-3
1.6 Symbols ................................................................................................................. 1-5

2 Product Specifications ...................................................................................................... 2-1


2.1 Product Name ........................................................................................................ 2-1
2.1.1 Physical Specifications ............................................................................. 2-1
2.1.2 Electrical Specifications ............................................................................ 2-2
2.1.3 Environment Requirements ...................................................................... 2-3
2.1.4 Product Specifications .............................................................................. 2-3
2.2 Testing Parameters ................................................................................................ 2-4
2.3 Performance Requirements................................................................................... 2-5
2.3.1 Background/Blank Count ......................................................................... 2-5
2.3.2 Carryover .................................................................................................. 2-5
2.3.3 Repeatability............................................................................................. 2-6
2.3.4 Linearity .................................................................................................... 2-8
2.4 Product Description ............................................................................................... 2-9
2.4.1 Main unit ................................................................................................. 2-12
2.4.2 Power/status indicator ............................................................................ 2-12
2.4.3 Power input connector ........................................................................... 2-12
2.4.4 [Aspiration] Key ...................................................................................... 2-12
2.4.5 USB ports ............................................................................................... 2-12
2.5 Product Configuration .......................................................................................... 2-12
2.6 Reagents, Controls and Calibrators .................................................................... 2-12
2.6.1 Reagents ................................................................................................ 2-13
2.6.2 Controls and Calibrators ........................................................................ 2-14
2.7 Information Storage Capacity .............................................................................. 2-14

3 System Principles .............................................................................................................. 3-1


3.1 Introduction ............................................................................................................ 3-1
3.2 Analyzer Workflow ................................................................................................. 3-1
3.3 Aspiration ............................................................................................................... 3-2
3.4 Dilution ................................................................................................................... 3-2
3.5 WBC Measurement ............................................................................................... 3-2
3.5.1 Measurement Principle ............................................................................ 3-2
3.5.2 WBC-Related Parameters ........................................................................ 3-3
3.5.3 HGB Measurement................................................................................... 3-5

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Table of Contents

3.6 RBC/PLT Measurement ......................................................................................... 3-5


3.6.1 Impedance Method................................................................................... 3-5
3.6.2 RBC-Related Parameters ........................................................................ 3-6
3.6.3 PLT-Related Parameters .......................................................................... 3-8
3.7 Wash ...................................................................................................................... 3-9
3.8 Troubleshooting ..................................................................................................... 3-9
3.8.1 Flags ......................................................................................................... 3-9
3.8.2 Relationship Between Flag Message and Parameter Flag .................... 3-11

4 Software and Interface ...................................................................................................... 4-1


4.1. Login ...................................................................................................................... 4-1
4.1.1 User ID and Password for Service Level Access ..................................... 4-1
4.1.2 System Self-test When Logging in at Service Access Level .................... 4-1
4.2 Review ................................................................................................................... 4-3
4.2.1 Trend Graph ............................................................................................. 4-3
4.3 Calibration.............................................................................................................. 4-4
4.3.1 Calibration Factors ................................................................................... 4-4
4.3.2 Calibration with Calibrator ........................................................................ 4-5
4.3.3 Gain Calibration (for only BC-10e) ........................................................... 4-6
4.4 Gain Calibration (for models except BC-10e)........................................................ 4-7
4.5 Gain Setup ............................................................................................................. 4-9
4.6 Sample Probe Debug .......................................................................................... 4-10
4.7 Performance ........................................................................................................ 4-11
4.7.1 Background Count.................................................................................. 4-12
4.7.2 Reproducibility ........................................................................................ 4-13
4.7.3 Carryover ................................................................................................ 4-14
4.8 Advanced Toolbox ............................................................................................... 4-14
4.8.1 Language Setup ..................................................................................... 4-16
4.8.2 Other Settings ........................................................................................ 4-16
4.8.3 One-key Export ...................................................................................... 4-16
4.9 Software Update .................................................................................................. 4-16
4.9.1 Prepare the USB for update ................................................................... 4-16
4.9.2 Update .................................................................................................... 4-17
4.10 Status Indicator .................................................................................................... 4-19
4.11 Buzzer .................................................................................................................. 4-20

5 Data Transmission ............................................................................................................. 5-1


5.1 LIS Connection ...................................................................................................... 5-1
5.1.1 Network Communication .......................................................................... 5-1
5.1.2 Serial Interface Communication ............................................................... 5-3
5.1.3 Transmission Mode .................................................................................. 5-4
5.2 Setup of Data Management Software ................................................................... 5-5
5.2.1 Communication Parameter Setup ............................................................ 5-5
5.2.2 Communication Instrument Management ................................................ 5-6

2
Table of Contents

5.3 Troubleshooting for Communication Errors ........................................................... 5-6

6 Fluidics 6-1
6.1 Introduction to Fluidic Parts ................................................................................... 6-1
6.1.1 Mindray valves ......................................................................................... 6-1
6.1.2 LVM fluidic valve ....................................................................................... 6-2
6.1.3 Linkage Syringe Device ........................................................................... 6-2
6.1.4 Preheating bath ........................................................................................ 6-3
6.1.5 Vacuum pump .......................................................................................... 6-4
6.1.6 Air pump ................................................................................................... 6-4
6.1.7 Sample probe ........................................................................................... 6-5
6.1.8 Probe wipes .............................................................................................. 6-6
6.1.9 Baths ........................................................................................................ 6-6
6.1.10 Filters ................................................................................................ 6-7
6.2 Sample Dilution Flow Chart ................................................................................... 6-8
6.2.1 Whole Blood Mode (for Dual-Bath Analyzers) ......................................... 6-9
6.2.2 Whole Blood Mode (for Single-Bath Analyzers Except BC-10e) ........... 6-10
6.2.3 Predilute Mode (for Dual-Bath Analyzers) .............................................. 6-12
6.2.4 Predilute Mode (for Single-Bath Analyzers) ........................................... 6-13
6.2.5 Whole Blood Mode (for Single-Bath BC-10e Only) ................................ 6-15
6.3 Introduction to Fluidic Channels .......................................................................... 6-16
6.3.1 Fluidic Channels for Dual-Channel Analyzers ........................................ 6-16
6.3.2 Fluidic Channels for Single-Channel Analyzers Except BC-10e ............ 6-18
6.3.3 Fluidic Channels for Single-Bath BC-10e .............................................. 6-19
6.4 Sample Volume ................................................................................................... 6-20
6.5 Temperature of Fluidics ....................................................................................... 6-20
6.5.1 Introduction to the Thermo System ........................................................ 6-20
6.5.2 Diluent Heating System .......................................................................... 6-21
6.6 Introduction to Sequences ................................................................................... 6-22
6.6.1 Analysis Sequence under Whole Blood Mode ....................................... 6-22
6.6.2 Analysis Sequence under Predilute Mode ............................................. 6-29
6.6.3 Introduction to Major Maintenance Sequences ...................................... 6-29

7 Hardware System............................................................................................................... 7-1


7.1 Hardware System Function Block Diagram ........................................................... 7-1
7.2 Electrical Connection Diagram .............................................................................. 7-2
7.3 Main Control Board ................................................................................................ 7-3
7.3.1 Overview .................................................................................................. 7-3
7.3.2 Components ............................................................................................. 7-3
7.3.3 Debugging and Troubleshooting .............................................................. 7-8
7.4 Power Assembly .................................................................................................. 7-11
7.4.1 Overview ................................................................................................ 7-11
7.4.2 Overview of the Original Power Assembly ............................................. 7-11
7.4.3 Power Board Replacing and Wiring for the Original Power Assembly ... 7-13

3
Table of Contents

7.4.4 Overview of the New Power Assembly .................................................. 7-14


7.4.5 Power Board Replacing and Wiring for the New Power Assembly ........ 7-15
7.5 Touch Screen Control Board ............................................................................... 7-16
7.5.1 Introduction ............................................................................................. 7-16
7.5.2 Components ........................................................................................... 7-16
7.6 Indicator Board .................................................................................................... 7-16
7.6.1 Introduction ............................................................................................. 7-16
7.6.2 Components ........................................................................................... 7-17
7.7 Motors, Photocouplers and Micro-switches ......................................................... 7-17
7.7.1 Introduction ............................................................................................. 7-17
7.8 Liquid Detection Board ........................................................................................ 7-18
7.8.1 Introduction ............................................................................................. 7-18
7.8.2 Components ........................................................................................... 7-18
7.9 Hardware Troubleshooting .................................................................................. 7-18
7.9.1 System Error .......................................................................................... 7-18
7.9.2 Troubleshooting for Main Control Board ................................................ 7-20
7.9.3 Power Board Errors ................................................................................ 7-24
7.9.4 Touch Screen Control Board Errors ....................................................... 7-24
7.9.5 Indicator Board Errors ............................................................................ 7-26
7.9.6 Motor and Photocoupler Errors .............................................................. 7-27
7.9.7 Liquid detection board error ................................................................... 7-27

8 Mechanical System............................................................................................................ 8-1


8.1 Introduction to Mechanical Structure ..................................................................... 8-1
8.1.1 Front of the Analyzer ................................................................................ 8-1
8.1.2 Back of the Analyzer ................................................................................ 8-3
8.1.3 Left Side of the Analyzer .......................................................................... 8-4
8.1.4 Right Side of the Analyzer ........................................................................ 8-5
8.2 Overview of Assemblies ........................................................................................ 8-5
8.2.1 Introduction ............................................................................................... 8-5
8.2.2 Whole Device ........................................................................................... 8-6
8.2.3 Main Unit .................................................................................................. 8-7
8.2.4 Front Cover Assembly (8.4 in) ................................................................ 8-10
8.2.5 Front Cover Assembly (10.4 inch) .......................................................... 8-12
8.2.6 Syringe Assembly ................................................................................... 8-13
8.2.7 Sample Probe Assembly ........................................................................ 8-14
8.2.8 WBC Bath Assembly .............................................................................. 8-15
8.2.9 RBC Bath Assembly ............................................................................... 8-16
8.2.10 Pump Assembly .............................................................................. 8-17
8.2.11 Power Unit ...................................................................................... 8-18
8.2.12 Reagent Detection Assembly ......................................................... 8-19
8.3 Disassembly and Installation ............................................................................... 8-19
8.3.1 Tools ....................................................................................................... 8-19
8.3.2 Before Disassembly ............................................................................... 8-20

4
Table of Contents

8.4 Removing the Main Unit ...................................................................................... 8-21


8.4.1 Remove Left Door Assembly .................................................................. 8-21
8.4.2 Remove Main Control Board .................................................................. 8-22
8.4.3 Remove the right door ............................................................................ 8-24
8.4.4 Remove the RBC Bath Assembly .......................................................... 8-24
8.4.5 Remove WBC bath and HGB Light Assembly ....................................... 8-25
8.4.6 Remove Preheating Assembly ............................................................... 8-26
8.4.7 Remove Right Side Valve Assembly ...................................................... 8-27
8.4.8 Remove Liquid Detection Board PCBA ................................................. 8-28
8.4.9 Remove Waste Pump ............................................................................ 8-29
8.4.10 Remove the Air Pump ..................................................................... 8-30
8.4.11 Remove Vacuum Chamber Assembly ............................................ 8-30
8.4.12 Remove the Diluent Temperature Sensor ...................................... 8-31
8.4.13 Remove the Top Cover ................................................................... 8-32
8.4.14 Remove the Aspiration Module ....................................................... 8-32
8.4.15 Remove the Motor Horizontal Photocoupler Assembly of Aspiration
Module 8-34
8.4.16 Replace Sample Probe ................................................................... 8-34
8.4.17 Remove the Probe Wipe ................................................................ 8-35
8.4.18 Remove the Aspiration Module Photocoupler in Vertical Direction 8-36
8.4.19 Remove the Front Cover Assembly ................................................ 8-37
8.4.20 Remove Indicator PCBA ................................................................. 8-39
8.4.21 Remove the Touch Screen Control Board ...................................... 8-40
8.4.22 Remove the Touch Screen Assembly ............................................. 8-41
8.4.23 Remove the Touch Screen ............................................................. 8-41
8.4.24 Remove the Micro-switch Assembly ............................................... 8-42
8.4.25 Remove the Syringe ....................................................................... 8-44
8.4.26 Remove the Syringe Motor ............................................................. 8-45
8.4.27 Remove the Syringe Motor Position Photocoupler Assembly ........ 8-45
8.4.28 Replace RBC/WBC Isolation Chamber Filter ................................. 8-46
8.4.29 Replace Power Unit ........................................................................ 8-47
8.4.30 Remove the Recorder .................................................................... 8-48
8.5 HGB Assembly Replacement .............................................................................. 8-49
8.5.1 Maintenance Protocol ............................................................................ 8-50

9 Troubleshooting................................................................................................................. 9-1

10 Adjustment ..................................................................................................................... 10-1


10.1 Adjusting Mechanical Positions ........................................................................... 10-1
10.2 Adjusting Analysis Components .......................................................................... 10-5
10.2.1 Counting Channel Test ................................................................... 10-5
10.3 Saving the Settings .............................................................................................. 10-7

11 Debugging and Validation After Servicing .................................................................. 11-1

5
Table of Contents

12 Service BOM................................................................................................................... 12-1

13 Appendices.......................................................................................................................A-1

A. Fluidic diagram ....................................................................................................A-1

B. Connection and Tube ..........................................................................................B-1

C. Hardware block diagram .....................................................................................C-1

D. Cables and Wires .................................................................................................D-1

E. Menu Tree ............................................................................................................. E-1

F. Appendix Table .................................................................................................... F-1

6
1 Using This Manual
1.1 Overview
This chapter describes how to use the service manual. In this manual, the repair methods of
Mindray’s new 3-DIFF series auto hematology analyzers, including BC-20s, BC-21s, BC-30s,
BC-31s, BC-10, BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e, and Mindray’s new
3-DIFF series hematology analyzer BC-10e are described in details.
Among which, analyzers BC-20s, BC-21s, BC-30s, BC-31s, BC-30, BC-31, BC-30e adopt
dual-bath design, and analyzers BC-10, BC-11, BC-10e, BC-20, and BC-21 adopt single-bath
design, that is, cancel the RBC bath and share the same bath for RBC and WBC count.
Analyzers BC-20s, BC-21s, BC-30s, BC-31s adopt sensors for detecting whether there is
reagent residue. While, analyzers BC-10, BC-11, BC-10e, BC-20, BC-21, BC-30, BC-31,
BC-30e use software to calculate the remaining reagent volume while cancel sensors for
detecting reagent.

Use Software
Adopt Use Sensors for Calculation
Adopt Dual-Bath
Analyzer Single-Bath for Reagent of Remaining
Design
Design Detection Reagent
Volume

BC-20s √ X √ X

BC-21s √ X √ X

BC-30s √ X √ X

BC-31s √ X √ X

BC-30 √ X X √

BC-31 √ X X √

BC-30e √ X X √

BC-20 X √ X √

BC-21 X √ X √

BC-10 X √ X √

BC-11 X √ X √

BC-10e X √ X √

The differences between the services of all models of analyzers are described in the following
context.
Before servicing analyzers, please carefully read and understand the content in order to
properly carry out maintenance procedures and ensure the safety of service personnel.
This manual must be used in conjunction with the Operator’s manual. It does not contain

1-1
Using This Manual

information and procedures already covered in the Operator’s manual.

NOTE
 Be sure to operate and service the analyzer strictly as instructed in this
manual and the operator’s manual.

1.2 Who Should Read This Manual


This manual is intended to be read by service professionals who:

 Have comprehensive knowledge of circuitry and fluidics;

 Have comprehensive knowledge of reagents;

 Have comprehensive knowledge of quality control;

 Have comprehensive knowledge of troubleshooting;

 Are familiar with the operations of the system;

 Are able to use basic mechanical tools and understand the terminology;

 Are skilled users of the digital voltmeter and oscillograph;

 Are able to analyze the circuit diagrams and fluidic charts.

1.3 Using This Manual


This manual comprises 12 chapters and 6 appendices. Refer to the table below to find the
information you need.
If you want to … See...
learn about the 3-DIFF analyzers’ physical specifications Chapter 2 Product
Specifications
learn about the 3-DIFF analyzers’ parameters, respective Chapter 3 System Principles
ranges and test principle
learn about interface introduction and upgrading of Chapter 4 Software and
BC-20s/BC-30 Interface
learn about the 3-DIFF analyzers’ external interface Chapter 5 Data Transmission
settings
learn about the composition, dosage, basic channels and Chapter 6 Fluidics
time sequence of the 3-DIFF analyzers’ fluidic system
learn about the 3-DIFF analyzers’ hardware structure; Chapter 7 Hardware System
composition, adjusting, testing points and
troubleshooting of each board
learn about the 3-DIFF analyzers’ structure, disassembly Chapter 8 Mechanical System
and verification
learn about the 3-DIFF analyzers’ errors and Chapter 9 Troubleshooting

1-2
Using This Manual

troubleshooting
Debug after the 3-DIFF analyzers being serviced Chapter 10 Adjustment
Debugging and verification after the 3-DIFF analyzers Chapter 11 Debugging and
being serviced Validation After Servicing
learn about the 3-DIFF analyzers’ service BOM Chapter 12 Service BOM
learn about the 3-DIFF analyzers’ fluidic diagrams Appendix A Fluidic diagram
learn about the 3-DIFF analyzers’ fluidic tube connectors Appendix B Connection and
Tube
learn about the 3-DIFF analyzers’ hardware diagrams Appendix C Hardware block
diagram
learn about the 3-DIFF analyzers’ cables and wires Appendix D Cables and Wires
learn about the 3-DIFF analyzers menus and functions Appendix E Menu Tree
for different access levels
/ Appendix F Appendix Table

1.4 Conventions Used in This Manual


This manual uses certain typographical conventions to clarify meaning in the text:
Format Meaning
[××] all capital letters enclosed in [ ] indicate a key name (either on
the pop-up keyboard or the external keyboard)
“××” letters included in " " indicate text you can find on the screen
of The 3-DIFF analyzers
×× italic letters indicate titles of the chapters that are referred to

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

1.5 Safety Information


You will find the following symbols in this manual.
Symbols Meaning

read the statement below the symbol. The statement is alerting


you to a potentially biohazardous condition.

read the statement below the symbol. The statement is alerting


WARNING you to an operating hazard that can cause personnel injury.

read the statement below the symbol. The statement is alerting


CAUTION you to a possibility of analyzer damage or unreliable analysis
results.

1-3
Using This Manual

read the statement below the symbol. The statement is alerting


NOTE you to information that requires your attention.

 All the samples, controls, calibrators, reagents, wastes and areas contacted
by them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them in the laboratory.

 If the main unit of the instrument leaks, the leaked liquid is potentially
biohazardous.

WARNING
 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.

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


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

 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.

 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.

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

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


injury during normal operation, removal, maintenance and verification.

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


according to government regulations.

 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.

 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.

1-4
Using This Manual

 Check the equipment state after repair. Make sure the equipment is safe
before offering it to users.

CAUTION
 Improper maintenance may damage the analyzer. Maintain the analyzer
strictly as instructed by the service manual and inspect the analyzer
carefully after the maintenance.

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


customer service department for maintenance advice.

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


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

 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.

NOTE
 The operator is required to follow the instructions below this symbol. The
instructions will emphasize important information or information that
requires particular attention of the operator.

1.6 Symbols
Symbols used in this service manual:

Symbol Meaning
The operator is required to follow the instructions
below this symbol. Failure to do so may place the
operator at a potential risk of biohazard.
The operator is required to follow the instructions
WARNING below this symbol. Failure to do so may cause
personal injury.
The operator is required to follow the instructions
below this symbol. Failure to do so may cause
CAUTION malfunction or damage of the product or affect the test
results.

1-5
Using This Manual

The operator is required to follow the instructions


below this symbol. The instructions will emphasize
NOTE important information or information that requires
particular attention of the operator.

The analyzer system may contain the following symbols:

CAUTION
 Ensure the labels are in good condition and not damaged while servicing the
analyzer.

When you see... It means...

Caution
Note: Indicates the need for the user to
consult the instructions for use for important
cautionary information such as warnings and
precautions that cannot, for a variety of
reasons, be presented on the medical device
itself.
Biological risks

The sample probe is sharp and potentially


biohazardous. Exercise caution when
working around it!
(Off) Power

(On) Power

PROTECTIVE CONDUCTOR TERMINAL

Alternating current

In vitro diagnostic medical device

1-6
Using This Manual

Serial number

Humidity limitation

Atmospheric pressure limitation

Temperature limit

Date of manufacture

Manufacturer

THE DEVICE IS FULLY CONFORMANCE


WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC
MEDICAL DEVICES 98/79/EC.
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

1-7
2 Product Specifications

2.1 Product Name


 Name: Hematology Analyzer

 Model:BC-10e

 Name: Auto Hematology Analyzer

 Model:
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-20/BC-21/BC-30/BC-31/BC-30e

2.1.1 Physical Specifications

Table 2-1 Dimensions and weight

Analyzer
Width (mm) ≤300
Height (mm) ≤400 (foot pad included)
Depth (mm) ≤410
Weight (Kg) ≤20

2-1
Product Specifications

Model Touch Screen Size


BC-30s 10 inch

BC-31s 10 inch

BC-20s 8 inch

BC-21s 8 inch

BC-30 10 inch

BC-31 10 inch

BC-30e 10 inch

BC-20 10 inch

BC-21 10 inch

BC-10 8 inch
BC-11 8 inch

BC-10e 8 inch

2.1.2 Electrical Specifications

Table 2-2 Main unit power supply

Parameter Value
Voltage (100V-240V~) ±10%

Input Power ≤180VA

Frequency (50/60Hz)±1Hz

WARNING
 Only fuses of specified specification shall be used.

Fuse Specification: 250V T3.15AH

2-2
Product Specifications

2.1.3 Environment Requirements


2.1.3.1 Operating environment, storage environment and running
environment
Table 2-3 Overall environment requirements

Storage and
Normal Operation Running
Transportation
Environment Environment
Environment
Requirements Requirements
Requirements

Ambient
15℃~30℃ -10℃~40℃ 10℃~40℃
Temperature

Relative
20%~85% 10%~90% 10%~90%
Humidity
Atmospheric
70kPa~106kPa Note1 50kPa~106kPa 70kPa~106kPa
Pressure

Note1: The altitude requirement for instrument normal operation is -400m~3000m.

2.1.4 Product Specifications


2.1.4.1 Sample mode
For
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-10e/BC-20/BC-21/BC-30/BC-31/BC-30e,
two sample modes are provided: whole blood mode and prediluted mode.

2.1.4.2 Throughput
Model Whole-Blood (WB) Mode Predilute (PD) Mode
BC-30s No less than 70 samples/hour No less than 70 samples/hour

BC-31s No less than 70 samples/hour No less than 70 samples/hour

BC-30 No less than 60 samples/hour No less than 60 samples/hour

BC-31 No less than 60 samples/hour No less than 60 samples/hour

BC-30e No less than 60 samples/hour No less than 60 samples/hour

BC-20s No less than 40 samples/hour No less than 40 samples/hour


BC-21s No less than 60 samples/hour No less than 60 samples/hour

BC-20 No less than 40 samples/hour No less than 40 samples/hour

2-3
Product Specifications

BC-21 No less than 40 samples/hour No less than 40 samples/hour

BC-10 No less than 30 samples/hour No less than 30 samples/hour

BC-11 No less than 30 samples/hour No less than 30 samples/hour

BC-10e No less than 30 samples/hour No less than 30 samples/hour

2.2 Testing Parameters


The analyzer provides quantified results for 20 to 21 report parameters (WBC, RBC, PLT,
HGB, etc.) and 3 histograms (WBC, RBC, and PLT). See the table below for details.

Table 2-4 Parameters

Name Abbreviation
White Blood Cell count WBC
Lymphocyte number Lymph#
Mid-sized Cell number Mid#
Granulocyte number Gran#
Lymphocyte percentage Lymph%
Mid-sized Cell percentage Mid%
Granulocyte percentage Gran%
Red Blood Cell count RBC
Hemoglobin concentration HGB
Mean Corpuscular Volume MCV
Mean Corpuscular Hemoglobin MCH
Mean Corpuscular Hemoglobin Concentration MCHC
Red Blood Cell Distribution Width Coefficient of Variation RDW-CV
Red Blood Cell Distribution Width Standard Deviation RDW-SD
Hematocrit HCT
Platelet count PLT
Mean Platelet Volume MPV
Platelet Distribution Width PDW
Plateletcrit PCT
Platelet Larger Cell Ratio P-LCR
Platelet Larger Cell Count* P-LCC*
Note: P-LCC only applies to BC-20s, BC-21s, BC-30s, BC-31s, BC-30, BC-31, and BC-30e.

Table 2-5 Histograms

White Blood Cell Histogram WBC Histogram


Red Blood Cell Histogram RBC Histogram
Platelet Cell Histogram PLT Histogram

2-4
Product Specifications

2.3 Performance Requirements


2.3.1 Background/Blank Count
Background refers to the background count performed automatically by the analyzer during
the startup process; its result shall meet the requirements in the following table.
The blank count requirements apply to both whole blood and predilute modes.
Blank count test method: run diluent on the analyzer consecutively for 3 times, the highest
value among the 3 results shall meet the requirements in the following table.

Table 2-6 Background/blank count requirements

Parameter Background/Blank Count Requirements


WBC ≤ 0.20 109 / L
RBC ≤ 0.02 1012/ L
HGB ≤1 g/L
HCT ≤ 0.50 %
PLT ≤ 5  109 / L

2.3.2 Carryover
Carryover refers to the carryover and contamination from high concentration sample to low
concentration sample.
Verification method:
Prepare a high concentration sample (centrifuged high value control or special high value
linearity control) which is within the range specified in Table 2-6, mix and then test it
consecutively for 3 times, and the test results are i1, i2, and i3; prepare a low concentration
sample (diluted low value control, dilution ratio: 1:10) which is within the range specified in
Table 2-6, test it consecutively for 3 times, and the test results are j1, j2, and j3. Calculate the
carryover according to the following equation, and the result shall meet the requirements in
Table 2-7.

2-5
Product Specifications

Table 2-7 Carryover Requirements

Parameter Carryover
WBC ≤0.5%
RBC ≤0.5%
≤0.5%(applicable to BC-20s, BC-21s, BC-30s, BC-31s, BC-10,
HGB BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e)
≤1.0%(applicable to BC-10e)
PLT ≤1.0%

Table 2-8 Sample Concentration Range of Carryover Test

High Concentration
Parameter Unit Low Concentration Range
Range
WBC ×109/L > 15.00 < 3.00
RBC ×1012/L > 6.00 < 2.00
HGB g/L > 200 < 40
PLT ×109/L > 300 < 100
HCT % > 54.0 < 18.0

2.3.3 Repeatability
Test a sample which meets repeatability requirement for the analyzer consecutively for 10
times, calculate the CV(%) and absolute deviation (d) of each parameter, and the results shall
meet the requirements in the following table.

In the equation:
s ----standard deviation of sample test results;
x ----mean value of sample test results;

xi
----actual test result of the sample;
d ----absolute deviation of the sample test results.

Table 2-9 Repeatability Requirements for BC-10e

Whole Blood Predilute


Parameter Condition
Repeatability Repeatability

WBC (4.00 ~ 15.00) 109 / L ≤ 4.0% ≤ 4.0%

RBC (3.50 ~ 6.50)  1012 / L ≤ 2.5% ≤ 2.5%

HGB (100 ~ 180) g/L ≤ 2.0% ≤ 2.0%

2-6
Product Specifications

PLT (100 ~ 500)  109 / L ≤ 8.0% ≤ 8.0%

MCV 70.00 fL~110.00 fL ≤ 1.5% ≤ 1.5%

Table 2-10 Repeatability Requirements for BC-20s, BC-21s, BC-30s, BC-31s, BC-10,
BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e

Whole Blood
Predilute Repeatability
Repeatability
Parameter Condition (CV/absolute deviation
(CV/absolute deviation
d)
d)
(7.00~15.00)  109 /L ≤2.0%
WBC ≤4.0%
(4.00 ~ 6.90) 109 / L ≤3.5%
(3.50 ~ 6.50)  1012 / L ≤1.5% (applicable to ≤2.0% (applicable to
BC-20s, BC-21s, BC-30s, BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-31, BC-31s, BC-30, BC-30e,
and BC-30e) and BC-31)
RBC
≤2.0 % (applicable to ≤ 2.5%
BC-20. BC-21, BC-10,
(applicable to BC-20,
and BC-11)
BC-21, BC-10, and
BC-11)
HGB 100 ~ 180 g/L ≤1.5% ≤2.0%
70.00~110.00 fL ≤0.5% (applicable to ≤1.5%
BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-31,
MCV and BC-30e)
≤1.0% (applicable to
BC-20, BC-21, BC-10,
and BC-11)
(100 ~ 149)  109/ L ≤5.0% ≤8.0% (applicable to
BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-30e,
and BC-31)
≤10.0%

PLT (applicable to BC-20,


BC-21, BC-10, and
BC-11)
(150 ~ 500)  109 /L ≤4.0% (applicable to ≤8.0% (applicable to
BC-20s, BC-21s, BC-30s, BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-31, BC-31s, BC-30, BC-30e,
and BC-30e) and BC-31)

2-7
Product Specifications

≤5.0% (applicable to ≤10.0%

BC-20, BC-21, BC-10, (applicable to BC-20,


and BC-11) BC-21, BC-10, and
BC-11)

2.3.4 Linearity
Samples of different concentrations were tested in both whole blood and predilute modes; the
slope and intercept were calculated per the linear regression equation, and then the deviation
between the theoretical value and test result was obtained, which shall meet the
requirements in the following table.

Table 2-11 Linearity requirements for BC-10e

Deviation Range Deviation Range


Parameter Linearity range
(Whole Blood) (Predilute)

WBC (0~100.0)×109/L ±0.50×109/L or ±5% ±0.50×109/L or ±5%

RBC (0~8.00)×1012/L ±0.05×1012/L or ±5% ±0.05×1012/L or ±5%

HGB (0-280)g/L ±2g/L or ±3% ±2g/L or ±3%

PLT (0~1000)×109/L ±10×109/L or ±10% ±10×109/L or ±10%

HCT (0~60)% ±4% (HCT value) or


±6% (percentage error)
Note: The linearity ranges above are expressed in both absolute deviation and deviation
percent, meeting either of the ranges are OK

Table 2-12 Linearity Requirements for BC-20s, BC-21s, BC-30s, BC-31s, BC-10, BC-11,
BC-20, BC-21, BC-30, BC-31, and BC-30e

Deviation Range
Parameter Linearity Range Deviation Range (Predilute)
(Whole Blood)

WBC (0.0~100.00)×109/L ±0.30×109/L or ±0.50×109/L or ±5%


±5%

(100.10 ~ ±9% ±18%


300.00)×109/L
(applicable to BC-30s,
BC-31s, BC-30,
BC-31, and BC-30e)

RBC (0.0~8.00)×1012/L ±0.05×1012/L or ±0.05×1012/L or ±5%


±5%

2-8
Product Specifications

HGB 0~280g/L ±2g/L or ±2% ±2g/L or ±3%

PLT (0~1000)×109/L ±10×109/L or ±10×109/L or ±10%


±10%

(1001 ~ 4000)×109/L ±12% ±20%


(applicable to BC-30s,
BC-31s, BC-30,
BC-31, and BC-30e)

HCT 0~67% ±4% (HCT value) /


or ±6% (deviation
percent)
Note: The linearity ranges above are expressed in both absolute deviation and deviation
percent, meeting either of the ranges are OK.

2.4 Product Description


A 3-DIFF (auto) hematology analyzers is mainly composed of the analysis module,
information management module, result output module and accessories.
Figures, pictures and drawings in this manual are prepared based on BC-30s/BC-31s, of
which the structure is basically the same as that of other 3-DIFF (auto) hematology analyzer
models.

WARNING
 The analyzer is heavy. Do not try to carry it by oneself, or serious injury may
be caused. It requires at least two persons to transport the analyzer. Use
necessary tools if possible.

2-9
Product Specifications

Figure 2-1 Front of the analyzer

1 ---- Display screen 2 ---- Power/status indicator


3 ---- Probe wipe block 4 ---- Sample probe
5 ---- [Aspirate] Key

2-10
Product Specifications

Figure 2-2 Back of the analyzer

1 --- USB interface 2 --- Network interface


3 --- Power input socket 4 --- Waste sensor connector
5 --- Waste outlet 6 --- M-3D diluent inlet

Figure 2-3 Left side of the analyzer

1 --- Recorder 2 --- Side door

2-11
Product Specifications

2.4.1 Main unit


The main unit performs sample analysis and data processing. It is the main part of the
instrument.

2.4.2 Power/status indicator


The power/status indicator locates at the middle position, right side of the front panel on the
main unit. It tells you about the status of the analyzer including ready, running, error, standby
and on/off, etc.

2.4.3 Power input connector


The power input socket is at the back of the main unit. It is used to turn on or off the analyzer.

CAUTION
 Once you turn on/off the analyzer, do not operate the power switch again in
10 seconds, or it may cause damage to the analyzer.

2.4.4 [Aspiration] Key


The [Aspiration] key locates at the front panel of the analyzer, in the middle part of the right
side. It is used to start the analysis, dispense diluent or exit the standby mode.

2.4.5 USB ports


The analyzer has 4 USB ports on the left panel of the main unit to connect peripherals and
transmit data.

2.5 Product Configuration


The standard product configuration includes the main unit, standard accessories and the
reagents. We also provide external barcode scanner and printer as optional accessories.
Connect the printer through the USB ports. Supported printer models include: EPSON
LQ-590K, HP Laser Jet P1505n, HP OfficeJet Pro K5300, HP LaserJet P1606dn, HP Laserjet
1020 plus, EPSON LQ-310, HP319, HP310, HP deskjet1115, and HP LaserJet P2035.

2.6 Reagents, Controls and Calibrators


As the analyzer, reagents, controls and calibrators are components of a system, performance
of the system depends on the combined integrity of all components. You must only use the
Mindray-specified reagents, which are formulated specifically for the fluidic system of your

2-12
Product Specifications

analyzer in order to provide optimal system performance. Do not use the analyzer with
reagents from multiple suppliers. In such use, the analyzer may not meet the performance
specified in this manual and may provide unreliable results. All references related to reagents
in this manual refer to the reagents specifically formulated for this analyzer.
Each reagent package must be examined before use. Product integrity may be compromised
in packages that have been damaged. Inspect the package for signs of leakage or moisture.
If any sign of leakage or moisture is found, do not use the reagent.

NOTE
 Store and use the reagents as instructed by instructions for use of the
reagents.

 When you have changed the diluent, lyses, run a background to see if the
results meet the requirement.

 Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.

 After installing a new container of reagent, keep it still for a while before
use.

2.6.1 Reagents
 M-30D Diluent

As an isotonic reagent and with specified conductivity, M-30D diluent provides stable
environment for hematology analysis.

 M-30CFL Lyse (applicable to only BC-30s, BC-31s, BC-20s, and BC-21s)

M-30CFL lyse is formulated to lyse red blood cells and transform the hemoglobin released
from red blood cell into hemoglobin complex. It is used for WBC count, WBC 3-part
differential and HGB determination.

 M-20CFL Lyse (applicable to only BC-20, BC-21, and BC-30, BC-31, and BC-30e)

M-20CFL lyse is formulated to lyse red blood cells and transform the hemoglobin released
from red blood cell into hemoglobin complex. It is used for WBC count, WBC 3-part
differential and HGB determination.

 M-10CFL Lyse (applicable to only BC-10, BC-11, and BC-10e)

M-10CFL lyse is formulated to lyse red blood cells and transform the hemoglobin released
from red blood cell into hemoglobin complex. It is used for WBC count, WBC 3-part
differential and HGB determination.

2-13
Product Specifications

 M-3CFL Lyse

For use as a cyanide-free lytic reagent for quantitatively determining hemoglobin and for
counting and sizing leukocytes.

 Probe Cleanser

Probe Cleanser is used for the regular cleaning of the analyzer.

2.6.2 Controls and Calibrators


The controls and calibrators are used for the analysis quality control and calibration of the
analyzer.
The controls are suspension of simulated human blood, specifically manufactured to monitor
and evaluate the analysis precision of the analyzer. The controls are prepared with three
levels, namely low, normal and high. The calibrators are also suspension of simulated human
blood, specifically manufactured for the calibration of the analyzer, so as to build the
metrological traceability of analysis results. For the use and storage of controls and
calibrators, please refer to the Instruction for Use of each product.
All references related to the controls and calibrators in this manual refer to the "controls" and
"calibrators" specifically formulated for the analyzers by Mindray. You must buy those controls
and calibrators from Mindray or Mindray-authorized distributors.

2.7 Information Storage Capacity


Table 2-13 Data storage requirements

Data Storage Capacity


Models Information
(Unit: 10,000 samples)
BC-30s 50 The information stored

BC-31s 50 should at least include the

BC-30 40 following: (histogram),

BC-31 40 sample information, patient

BC-30e 20 information, flags as well as

BC-20s 20 any special information of the

BC-21s 20 analyzer.

BC-20 10

BC-21 10

BC-10 5

BC-11 5

BC-10e 3

2-14
3 System Principles

3.1 Introduction
The analyzer uses the electrical impedance method to determine the count and size
distribution of RBC, WBC and PLT; and uses the colorimetric method to determine HGB.
Based on the above data, the analyzer calculates other parameters.

3.2 Analyzer Workflow


We have defined the whole operation workflow of the analyzer by its major functions: reagent
system, sample loading and distribution, sample preparation, sample measurement, signal
processing, parameter analysis, status monitoring, scheduling control and information
processing, man-machine interface, power as well as cleaning and maintenance. The
relationships between the functions are illustrated as below:

Reagent

Reagent
metering
WBC
Measurement

WBC
RBC

Human Machine
Reaction Management
Measurement
Processing

Parameter
Sample

Interface
Analysis
Signal

Data

open-vial
RBC
HGB
Aspirate/ diluenting
Measurement
Dispense

HGB Sample
Scheduling Control
Reaction Detected and Information
Power
Supply
Processing
Sample
Preparation

Status
Detection

Waste
Clean Collection

Clean and Maintain

Fluid Flow Gas Flow Reagent Signal Stream

The Scheduling Control and Information Processing module coordinates and regulates other
functional modules to work by defined process and requirements, so as to ensure the
completing of sample measurement, the ultimate task of the analyzer.

3-1
System Principles

3.3 Aspiration
This analyzer can process two types of blood samples – whole blood samples and prediluted
blood samples.

 For BC-10e:

If you are going to analyze a whole blood sample under the whole blood (WB) mode, present
the sample to the analyzer and press the [Aspirate] key, the analyzer aspirates 20μL of the
sample. Press the [Aspirate] key for the second time, a diluted sample (about 1:36) will be
dispensed. Mix the sample thoroughly, present the well-mixed diluted sample to the analyzer
and press the [Aspirate] key, the analyzer aspirates 198 uL of the sample.
If you are to analyze a capillary blood sample under the predilute (PD) mode, you should first
manually dilute the sample (20 μL capillary sample needs to be diluted by 0.7 mL of diluent to
form a 1:36 dilution), and then present the pre-diluted sample to the analyzer, which will
aspirate 198uL of the sample.

 For BC-20s, BC-21s, BC-30s, BC-31s, BC-10, BC-11, BC-20, BC-21, BC-30, BC-31,
and BC-30e:

If you are to analyze a whole blood sample under the whole blood (WB) mode, present the
sample to the analyzer directly, and the analyzer will aspirate 9 μL of the whole blood sample.
If you are to analyze a capillary blood sample under the predilute (PD) mode, you should first
manually dilute the sample (20 μL capillary sample needs to be diluted by 0.7 mL of diluent to
form a 1:36 dilution), and then present the pre-diluted sample to the analyzer, which will
aspirate 198uL of the sample.

3.4 Dilution
Usually in blood samples, the cells are too close to each other to be identified or counted. For
this reason, the diluent is used to separate the cells so that they draw through the aperture
one at a time as well as to create a conductive environment for cell counting. Moreover, red
blood cells usually outnumber white blood cells by 1,000 times. Because red blood cells
usually have no nucleus, they are eliminated when the lyse breaks down their cell walls. For
this reason, lyse need to be added to the sample to eliminate the red cells before the WBC
counting. The analyzer provides whole blood mode and predilute mode for the analysis of
different sample types.

3.5 WBC Measurement


3.5.1 Measurement Principle
 WBC measurement principle

The WBCs are counted by the impedance method. The analyzer aspirates certain volume of
sample, dilutes it with certain volume of conductive solution, and delivers the dilution to the
metering unit. The metering unit has a little opening which is called "aperture". A pair of

3-2
System Principles

electrodes is positioned on both sides of the aperture, and creates a constant-current supply.
As cells are poor conductors, when each particle in the diluted sample passes through the
aperture under the constant negative pressure, a transitory change in the direct-current
resistance between the electrodes is produced. The change in turn produces a measurable
electrical pulse which is proportional to the particle size. And when the particles pass the
aperture in succession, a series of pulses are produced between the electrodes. The number
of pulses generated indicates the number of particles passed through the aperture; and the
amplitude of each pulse is proportional to the volume of each particle.
Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of certain amplitude. All the collected pulses are thus classified based on
the reference voltage ranges of different channels, and the number of the pluses in the WBC
channel indicates the number of the WBC particles. The cell size distribution width is
represented by the number of particles falling in each channel.

Figure 3-1 Metering diagram

3.5.2 WBC-Related Parameters


 White Blood Cell count

WBC (109/L) is the number of leukocytes measured directly by counting the leukocytes
passing through the aperture.
Sometimes there are nucleated red blood cells (NRBC) presenting in the sample. While the
lyse will not be able to break their nuclear membrane, these NRBCs will also be counted as
WBCs. Therefore when NRBCs are found during microscopic exam, follow below formula to
modify the WBC count:

In the formula, WBC′ is corrected WBC count result; WBC is the WBC count provided by the

3-3
System Principles

analyzer; and NRBC indicates the number of NRBCs found when every 100 WBCs are
counted.

 3-DIFF of WBC

Lyses and diluents change the sizes of each type of WBCs in various ways and at different
time. The WBCs are thus separated into 3 parts (from the largest size to the smallest):
lymphocytes, mid-sized cells (including monocytes, eosinophils, and basophils) and
granulocytes.
The analyzer then calculates the lymphocyte percentage (Lym%), mid-sized cell percentage
(Mid%) and granulocyte percentage (Gran%) (All presented in %) based on the WBC
histograms and in accordance with below formulae:

In the formulae: PL indicates the number of cells falling in the lymphocyte region, PM the
number of cells falling in the mid-sized cell region, and PG the number of cells falling in the
granulocyte region. All three parameters are presented in 109/L.
When the three percentages are obtained, the analyzer automatically proceeds to calculate
the lymphocyte number (Lym#), mid-sized cell number (Mid#) and granulocyte number
(Gran#) by below formulate, all parameters expressed in 109/L.

Lym%, Mid% and Gran% are expressed in %, while WBC is in 109/L.

 White blood cell histogram

Besides the count results, the analyzer also provides a WBC histogram which shows the
WBC size distribution, with the x-axis representing the cell size (in fL) and the Y-axis
representing relative cell number (in 109/L)(as shown below). The WBC histogram of a

3-4
System Principles

normal blood sample (lysed and processed) should show display 3 clear parts: the small cell
(about 20~70fl) region represents the LYM group (lymphocytes); the mid-sized cell (about
70~150fl) region represents the Mid group (including monocytes, eosinophils and basophiles);
and the large cell (over 150fl) region represents the Gran group (granulocytes).

After each analysis cycle, you can either check the WBC histogram in the analysis result area
on the "Sample Analysis" screen or review the histogram on the "Review" screen.

3.5.3 HGB Measurement


The HGB is determined by the colorimetric method. The diluted sample is delivered to the
WBC count bath where it is bubble mixed with a certain amount of lyse, which breaks red
blood cells, and converts hemoglobin to a hemoglobin complex. An LED is mounted on one
side of the bath and emits a beam of monochromatic light with 530~535nm central
wavelength of 530~535nm. The light is received by an optical sensor mounted on the
opposite side, where the light signal is first converted to current signal and then to voltage
signal. The voltage signal is then amplified and measured and compared to the blank
reference reading (reading taken when there is only diluent in the bath), and the HGB (g/L) is
measured and calculated automatically. The whole measurement and calculation process is
completed automatically. You can review the results in the analysis result area on the
"Sample Analysis" screen.
HGB is expressed in g/L.

 Blank Phot ocurrent 


HGB(g/L)  Constant  Ln  
 Sample Photocurr ent 

3.6 RBC/PLT Measurement


3.6.1 Impedance Method
RBCs/PLTs are counted by the electrical impedance method. The analyzer aspirates certain
volume of sample, dilutes it with certain volume of conductive solution, and delivers the
dilution to the metering unit. The metering unit has a little opening which is called "aperture".
A pair of electrodes is positioned on both sides of the aperture, and creates a
constant-current supply. As cells are poor conductors, when each particle in the diluted

3-5
System Principles

sample passes through the aperture under the constant negative pressure, a transitory
change in the direct-current resistance between the electrodes is produced. The change in
turn produces a measurable electrical pulse which is proportional to the particle size. And
when the particles pass the aperture in succession, a series of pulses are produced between
the electrodes. The number of pulses generated indicates the number of particles passed
through the aperture; and the amplitude of each pulse is proportional to the volume of each
particle.
Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of certain amplitude. All the collected pulses are thus classified based on
the reference voltage thresholds of different channels, and the number of the pluses in the
RBC/PLT channel indicates the number of the RBC/PLT particles. The cell size distribution
width is represented by the number of particles falling in each channel.

Figure 3-2 Metering diagram

3.6.2 RBC-Related Parameters


 Red Blood Cell count

RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.

 Mean Corpuscular Volume

The analyzer calculates the mean cell volume (MCV, in fL) based on the RBC histogram.

3-6
System Principles

 HCT, MCH and MCHC

The hematocrit (HCT, %), mean corpuscular hemoglobin (MCH, pg.) and mean corpuscular
hemoglobin concentration (MCHC, g/L) are calculated as follows:

Where RBC is expressed in 1012/L, MCV is expressed in fL and HGB is expressed in g/L.

 RDW-CV

Red Blood Cell Distribution Width - Coefficient of Variation (RDW-CV) is derived based on
RBC histogram. It is expressed in %, and indicates the variation level of RBC size
distribution.

 RDW-SD

Red blood cells distribution width - standard deviation (RDW-SD, in fL) measures the width of
the 20% level (with the peak taken as 100%) on the RBC histogram, as shown in Figure 3-3.

Figure 3-3

 Red blood Cell Histogram

Besides the count results, the analyzer also provides a RBC histogram which shows the
RBC size distribution, with the x-axis representing the cell size (in fL) and the Y-axis
representing relative cell number (in 1012/L)(as shown below). With a normal blood samples,
the RBCs mostly fall in the region of 70~120fl.

3-7
System Principles

After each analysis cycle, you can either check the RBC histogram in the analysis result area
on the "Sample Analysis" screen or review the histogram on the "Review" screen.

3.6.3 PLT-Related Parameters


 Platelet count

PLT (109/ L) is measured directly by counting the platelets passing through the aperture.

 Mean Platelet Volume

Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).

 PDW

Platelet distribution width (PDW) is derived from the platelet histogram, and is reported as 10
geometric standard deviation (10 GSD).

 PCT

The analyzer calculates the PCT (%) as follows:


where the PLT is expressed in 109/L and the MPV in fL.

 Platelet-Large Cell Ratio

The analyzer calculates the number of platelets larger than 12fl in size based on the platelet
histogram and then derives the large platelet ratio (%).

 Platelet Histogram

Besides the count results, the analyzer also provides a PLT histogram which shows the PLT
size distribution, As shown in below, most PLTs of a normal blood sample should fall into the
0~20fl region. with the x-axis representing the cell size (in fL) and the Y-axis representing
relative cell number (in 109/L).

After each analysis cycle, you can either check the PLT histogram in the analysis result area
on the "Sample Analysis" screen or review the histogram on the "Review" screen.

3-8
System Principles

3.7 Wash
After each analysis cycle, each element of the analyzer is washed:

 The sample probe is washed internally and externally with diluent;

 The baths are washed with diluent;

 Other elements of the fluidic system are also washed diluent.

3.8 Troubleshooting
3.8.1 Flags
The analyzer provides 26 algorithm flags. Refer to below table for flag meanings and
conditions.
Flag type Flag Message Indication Conditions
Possible presence of
platelet coagulation, large
platelets, nucleated red
blood cells (NRBC), red
Abnormal cell size distribution of
WBC Histogram cells which are not broken
WBC histogram in the left of the
R1 down, protein with large
LYM region
molecular weight and lipid
particulars. It may also
suggest electrical noise
interference.
Possible presence of
atypical/abnormal Abnormal cell size distribution of
WBC Histogram lymphocytes, plasma cells WBC histogram in the region
R2 and blasts. Or extra-high between the lymphocyte peak
WBC
numbers of eosinophils and the mid-sized cell region.
and basophiles.
Abnormal cell size distribution of
Possible presence of
WBC Histogram WBC histogram in the region
immature cells and blasts;
R3 between the mid-sized cell
or eosinophilia.
region and the granulocyte peak.
Possible presence of
large immature cells, Abnormal cell size distribution of
WBC Histogram
blasts, WBC agglutination WBC histogram in the right of the
R4
or high absolute number granulocyte peak.
of granulocyte.
More than one abnormal
WBC Histogram At least 2 WBC histogram R
cell size distribution type
Rm flags are reported.
exists.

3-9
System Principles

Abnormal WBC WBC histogram R flag is


Abnormal WBC histogram
size distribution reported
Leucopenia Low WBC count WBC < 2.50×10^9/L
Leucocytosis High WBC count WBC > 18.00×10^9/L
Granulopenia Low granulocyte count GRAN# < 1.00×10^9/L
Granulocytosis Low granulocyte number GRAN # > 11.00×10^9/L
lymphopenia Low lymphocyte number LYMPH# < 0.80×10^9/L
Lymphocytosis High lymphocyte number LYMPH# > 4.00×10^9/L
High mid-sized High mid-sized cell
MID# > 1.80×10^9/L
cell number number
WBC < 4.0×10^9/L and RBC <
Low WBC, RBC and PLT
Pancytopenia 3.5×10^9/L and PLT <
count
100×10^9/L
Possible presence of
microcytosis,
Abnormal RBC macrocytosis,
Abnormal RBC histogram
size distribution anisocytosis, RBC
agglutination and
diamorphologic histogram.
HGB results may be
RBC MCHC > 380 g/L
HGB abnormal or interference
or interfering parameters of HGB
Abn./Interfere? may exist (for example,
exceed allowable ranges
high WBC count)
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Anemia Anemia HGB < 90g/L
Erythrocytosis High RBC count RBC > 6.5×10^12/L
PLT Histogram High number of small
PLCR < 15%
Ps platelets.
PLT Histogram High number of large
PLCR > 50%
P1 platelets.
Possible presence of
The boundary of the PLT/RBC is
PLT Histogram microcytosis, RBC debris,
too confusing for the system to
PLT Pm large platelet and platelet
define.
coagulation.
Platelet
PLT histogram Pm flag is
distribution Abnormal PLT histogram
reported
abnormal
Thrombopenia Low PLT count PLT < 60×10^9/L
Thrombocytosis High PLT count PLT > 600×10^9/L

3-10
System Principles

3.8.2 Relationship Between Flag Message and Parameter Flag


Refer to the table below to see how related parameters will be marked when a certain flag is
reported.
Flag type Flag Message Parameter Flag
When the WBC histogram shows an R1 flag, parameters
WBC, GRAN%, LYM%, MID%, GRAN#, LYM#, and MID#
are marked with flag R;
When the WBC histogram shows an R2 flag, parameters
Abnormal WBC LYM%, MID%, LYM#, and MID# are marked with flag R;
size distribution When the WBC histogram shows an R3 flag, parameters
GRAN%, MID%, GRAN#, and MID# are marked with flag
R;
When the WBC histogram shows an R4 flag, parameters
WBC GRAN% and GRAN# are marked with flag R.
Leucopenia None.
Leucocytosis None.
Granulopenia None.
Granulocytosis None.
lymphopenia None.
Lymphocytosis None.
High mid-sized cell None.
number
Pancytopenia None.
When this message is reported, parameters RBC, HCT,
Abnormal RBC size
MCV, MCH, MCHC, RDWCV, and RDWSD are marked
distribution
with flag R.
HGB When this message is reported, parameters HGB, MCH,
RBC Abn./Interfere? and MCHC are marked with flag R.
Microcytosis None.
Macrocytosis None.
Anemia None.
Erythrocytosis None.
Platelet size
When this message is reported, parameters PLT, MPV,
distribution
PDW, PCT, PLCR and PLCC are marked with flag R.
PLT abnormal
Thrombopenia None.
Thrombocytosis None.

3-11
4 Software and Interface
4.1. Login
4.1.1 User ID and Password for Service Level Access
User ID: Service
Password: Se s700 (note there is a blank space between Se and s700).

NOTE
 Password is case sensitive.

4.1.2 System Self-test When Logging in at Service Access

Level
When you log in at service access level, the analyzer will automatically run a check matching
the backup data on the board card with the data in the SD card. If they are matched, the
analyzer starts up successfully, performs a background test, and then displays the "Sample
Analysis" screen.
If the board card or SD card has been replaced before, or the analyzer detects configuration
change before abnormal shutdown, you will be prompted to restore the system or back up
data.

Figure 4-1 System self-test prompt

Tap "OK" to enter the screen and follow the instructions to enter below screen and follow the
instruction to backup and restore the data:

4-1
Software and Interface

Figure 4-2 Backup and restore data

1. When the SD card has been replaced, follow the instruction and "restore" the important
parameters to the new SD card.
2. When the main control board has been replaced, follow the instruction and "backup" the
data to the new main control board.

NOTE
 Always perform the shutdown procedure before replacing the SD card or
main control board, so the data will be automatically backed up.

 All models of the new 3-DIFF series (auto) hematology analyzers use the
same main control board. The SD card of an analyzer carries the analyzer
type and calibration information. When a main control board is faulty, it can
be replaced with a new main control board but can only use its original SD
card.

4-2
Software and Interface

4.2 Review
4.2.1 Trend Graph
Operators can browse, validate, search, edit, and export data in the Table Review tab page.
Choose "Table Review" to enter the "Table Review tab" page, and then tap the "Trend
Graph" button to view the trend graph of sample results.

Figure 4-3 Trend graph screen

When the mean values of the selected parameter results are calculated, then the ordinates
corresponding to the mean value point, the upper limit point and the lower limit point are
Mean, Mean + Mean * 10%, and Mean – Mean * 10%.
Calculate the upper or lower limit of certain parameter result by "Mean + Deviation". If a result
does not confirm to the acceptable data format, round it up to get the corresponding
ordinates.
Tap the "Setup" button on the trend graph screen to enter the parameter limit setup screen
(as shown below):

4-3
Software and Interface

Figure 4-4 Setting up parameter limits

4.3 Calibration
4.3.1 Calibration Factors
Calibration is performed to ensure the analyzer may deliver accurate sample analysis results.
During the calibration process, a calibrator factor will be calculated. This factor will be used to
multiply with the analysis results to output the final results. When running a calibrator, the
analysis results after being adjusted by the factor should be as close to its assigned targets.
Thus the calibrator factor is derived by below formula:

For
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-10e/BC-20/BC-21/BC-30/BC-31/BC-30e,
the analyzer supports 3 calibration programs, namely manual calibration, auto calibration with
calibrators, and auto calibration with fresh blood samples.

 Manual calibration can be performed under two modes: "WB" and "PD".

 Auto calibration with calibrators can be performed under only WB mode.

 Auto calibration with fresh blood can be performed under two modes: "WB"
and "PD".

4-4
Software and Interface

Calibration with fresh blood can be performed under two modes: "WB" and "PD", which use
different fluidic sequences. Perform calibration with fresh blood for each of the two modes
separately.
All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be
calibrated by the calibration programs.
The following content describes only how to perform auto calibration with calibrators for
BC-20s/BC-21s/BC-30s/BC-31s/BC-10/BC-11/BC-10e/BC-20/BC-21/BC-30/BC-31/BC-30e.
For details on manual calibration, auto calibration with calibrator, and auto calibration with
fresh blood, see the operator's manual of the corresponding analyzer.

4.3.2 Calibration with Calibrator

Figure 4-5 Calibration at Service Access Level

When performing calibration with calibrator at service access level for


BC-20s/BC-21s/BC-30s/BC-31s/BC-10/ BC-11/BC-10e/BC-20/BC-21/BC-30/BC-31/BC-30e,
the analyzer calculates all factory calibration factors automatically. You need to run at least 5
calibrations to calculate and save calibration factors. When 10 calibrations are done, a dialog
box will be displayed prompting that calibration has been completed; and you will be
prompted to save the new calibration factors when exiting the screen.
Before calibration, make sure to set up the lot numbers, expiration dates, analysis modes and
the target values for the calibrators.
The calibration factors should fall into the range of [75%, 125%].

4-5
Software and Interface

CAUTION
 Only Mindray-specified calibrators shall be used. Mindray will not be
responsible for any erroneous result caused by using other calibrators.

 See the instruction for use of the calibrators for the lot No., expiration date
and the target.

NOTE
 If the calibrated factors or CVs are out of allowable range, they will be
displayed in red, and the values cannot be saved.

4.3.3 Gain Calibration (for only BC-10e)

Figure 4-6 Gain Calibration (for only BC-10e)

For BC-10e, choose Calibration > Gain Calibration to enter the gain calibration screen, as
shown in Figure 4-6.
Then, click the WBC histogram to check whether the WBC histogram is properly displayed
and determine how to adjust the gain setup if necessary, as shown in Figure 4-7.
For details on whether to adjust and how to adjust the gain setup, see 4.5 Gain Setup and
refer to the corresponding setting document.

4-6
Software and Interface

Figure 4-7 WBC histogram editing screen for BC-10e

4.4 Gain Calibration (for models except BC-10e)


For models BC-20s/BC-21s/BC-30s/BC-31s/BC-10/ BC-11/BC-20/BC-21/BC-30/BC-31/BC-30e
(that is, models except BC-10e), choose Maintenance > Gain Calibration to enter the gain
calibration screen.
This function is used to calibrate the gains for the RBC, WBC and HGB parameters, including
MCP, WCP, HGB, RBC effective width and WBC effective width. The purpose is to ensure
each channel may deliver reliable results.

4-7
Software and Interface

Figure 4-8 Gain Calibration

You can calibrate the gain factors for all parameters displayed above at the same time.
Among the parameters, the WBC/RBC effective width is calibrated by software with
averaging method. Tap the "Select" boxes to select the results used to calculate the mean
values. WCP, MCP and HGB gains instead are hardware gains and calibrated with
successive "approximation method". They are not affected whether any group of results is
"selected".
Invalid calibration results will be displayed in red. In this case, do the calibration again.
If the target of a parameter is not set, the parameter will not be calibrated (like MCP on
above figure).
The system will ask if you want to save the calibration factors when exiting the Gain
Calibration screen.

CAUTION
 The function only supports the calibration with calibrators.

 Never use expired calibrators.

 Refer to the calibrator target sheet provided manufacturer.

4-8
Software and Interface

4.5 Gain Setup


Choose Gain > Gain Setup to enter the "Gain Setup" screen.
You can set up the gain for HGB on the "Gain Setup" screen. Gains for other parameters are
obtained by gain calibration and cannot be edited.

Figure 4-9 Gain Setup

As the HGB gain is hardware gain, you need to adjust the blank voltage of the digital
potentiometer. Tap the "Auto Cal. HGB B.V" button, and the HGB blank voltage will be set
automatically.
MCP is the target RBC gain value for the calibrator. WCP is the target WBC gain value for the
calibrator. Service engineers and higher-priority users can input the target gain value
according to the target value sheet to calibrate the gain for the analyzer.

NOTE
 As the gain settings affect the validity of analysis results, be careful when
you adjust them.

4-9
Software and Interface

4.6 Sample Probe Debug


Choose Maintenance > Sample Probe Debug to enter the "Sample Probe Debug" screen.
The action is performed to test if the sample probe may properly move to its position.

Figure 4-10 Sample Probe Debug (for Dual-Bath Analyzers)

4-10
Software and Interface

Figure 4-11 Sample Probe Debug (for Single-Bath Analyzers)

When you enter the "Sample Probe Debug" screen, press the "Initialize" button first. The
sample probe debugging will only start after initialization. For details, please refer to 10.1
Adjusting Mechanical Positions.

4.7 Performance

NOTE
 For BC-10e, the performance measurement function needs to be performed
manually according to the corresponding formulas. to evaluate the
background, reproducibility, and carryover.

4-11
Software and Interface

4.7.1 Background Count

Figure 4-12 Background count

Enter the "Background count" screen and press the [Aspirate] key to start background count.
You do not need to run actual samples. The background is acceptable only when all the result
boxes display "pass" on the background count screen.

4-12
Software and Interface

4.7.2 Reproducibility

Figure 4-13 Reproducibility test

Test a sample which meets reproducibility requirement for the analyzer for 10 times, and
calculate the CV (%) and absolute deviation (d) of each parameter, and the results shall meet
the reproducibility requirements.

NOTE
 End users usually use normal controls to calculate the reproducibility.

4-13
Software and Interface

4.7.3 Carryover

Figure 4-14 Carryover test

Make sure the analyzer is working properly and steadily. Run a high value sample
consecutively for 3 times and then run a low value sample consecutively for 3 times.
Calculate the carryover per below formula:

First low - level sample result -Third low - level sample result
Carryover(%)   100%
Third high - level sample result -Third low - level sample result

4.8 Advanced Toolbox


The "Advanced Toolbox" provides the following functions: software update, language switch,
one-key data export, mid-sized cell classification line setting, and export of original pulse.
(see below).

4-14
Software and Interface

Figure 4-15 Advanced toolbox-System Configuration

Figure 4-16 Advanced toolbox-Other Settings

4-15
Software and Interface

4.8.1 Language Setup


The analyzer supports the Chinese and English languages.

NOTE
 When you change the language setting, the new language will only become
effective after restart.

4.8.2 Other Settings


 Org pulse enable

When "Org pulse enable" is enabled, the original pulse will be saved to the SD card of the
analyzer.

 Mid Width

The Mid Width function can be used to tune the mid-sized cell classification line.

4.8.3 One-key Export


You can use this function to export instrument information, software debug information,
reproducibility test results, accuracy test results, factory calibration results, background test
results, carryover results, aging data, as well as gain calibration results, system self-test
results, version information, configuration information, inf. files, and user operation logs.
The exported Spec Info folder only contains an AllSpecialInfo.csv file.

NOTE
 The USB should have been formatted to FAT32 before you copy and paste
the "update" directory to it.

 Recommended USB models: Kingston 8/16G, SanDisk 8/16G and Maxell


4/8G.

 Make sure there is enough free space (at least 4G) on the USB.

4.9 Software Update


4.9.1 Prepare the USB for update
Unzip the file named "update.tar.gz", and then copy the "update" directory in the unzipped file
to the root directory of the formatted USB.

4-16
Software and Interface

NOTE
 The USB should have been formatted to FAT32 before you copy and paste
the "update" directory to it.

 When the USB is ready, it should have an "update" folder under the root
directory, and the "update" folder further contains two sub-folders named
"step1" and "step2".

4.9.2 Update
Insert the USB to one of the USB ports on the analyzer, and perform update following either
of the below methods:

 Advanced Toolbox-Start Update

Figure 4-17 Advanced toolbox: update

 Version Info.- Start Update

4-17
Software and Interface

Figure 4-18 Version Info.: Update

The "Update" process includes two steps:


Step 1: update the guide and operation system;
Step 2: update the software module.
If the update guide and the operation system also need to be updated, the system will prompt
you to restart the analyzer between step 1 and step 2; if only the software module need to be
updated, the update will start from step 2 directly.

CAUTION
 Do not pull the USB or disconnect power during the update; otherwise the
analyzer may not start.

NOTE
 The update usually takes about 10 minutes but depends on the number of
modules to be updated. Do not leave the analyzer as the process requires
user operation.

 When update fails

If the update fails, try again.

4-18
Software and Interface

4.10 Status Indicator


The indicator on the front panel of the analyzer may light in 3 colors. When it flickers, it
flickers at the frequency of 2 seconds. The relationships between the indicator status and the
analyzer status are listed below:

Table 4-1 Status indicator

Analyzer status Indicator Remarks


Ready Static green Waiting for actions

Running Flickering green Performing actions

Running with error Flickering red Running, but there is/are error(s)
Error and not running Static red There is/are error(s), and the
analyzer is not running
No error, but fluidic actions are not Static yellow Startup initialization or standby,
allowed not involving fluidic actions

Enter/exit standby Flickering yellow Enter/exit standby

4-19
Software and Interface

4.11 Buzzer
When there is any error, the buzzer gives out an alarm sound. Tap the touch screen to silence
the buzzer; or when the errors are removed the alarm sound will stop automatically. The
buzzer also sounds in other ways indicating different system status.

Table 4-2 Buzzer sounds

When... The buzzer sounds Remarks


Startup process completed a short beep Startup process is completed
when the analyzer is started and
ready for analysis
Sample presentation/aspiration 2 short beeps
under open-vial mode is completed

On the analysis related screens A long beep When there are dialog boxes
(e.g. screens of sample analysis, popped out prompting further
QC, reproducibility, carryover, action, the buzzer may not
background, aging or gain sound.
calibration), press the [Aspiration]
key when it is not convenient to start
analysis

Error Long beeps at Tap the "Remove error" button to


intervals silent the buzzer
Analyzer ready 1 short beep Analyzer gets ready from other
status

The analyzer screen becomes Silent When there is/are error(s) during
black, and prompts "Please turn off shutdown process, the buzzer
the power of the analyzer!" stops when the analyzer screen
becomes black.

4-20
5 Data Transmission
5.1 LIS Connection
Communication Setup (Menu > Setup > System Setup > Communication)
You can set the following on the "Communication" screen:

 Network communication

 Serial interface communication

 Transmission Mode

5.1.1 Network Communication

Figure 5-1 Communication setup

5.1.1.1 Network Types


Network type: supports both "Wireless" and "Wired" devices.
 When using a wired network, you only need to set up the protocol;

 When using a wireless network, insert the wireless network card, and tap the button

on the right of the pull down list, the following dialog box is displayed.

5-1
Data Transmission

Select a Wi-Fi network, and then click the "Connect" button to connect the Wi-Fi
network.

Figure 5-2 Wi-Fi connection setup

5.1.1.2 Recommended network card models:


 NETGEAR: WNA3100M

 EDUP:EP-N8508GS

5.1.1.3 Protocol Setup


IP Address: IP address for the analyzer, which is 10.0.0.2 by default.
Subnet mask: subnet mask for the analyzer network, which is 255.255.255.0 by default.
Default gateway: IP address of the gateway.
Mac Address: Mac address of the analyzer, which is fixed by manufacturer and cannot be
changed.

Communication protocol: Tap the pull down list to select a suitable communication protocol.

5.1.1.4 ACK Synchronous Transmission:


Tap the "ACK synchronous transmission" check box to activate the function.
When the function is activated, ACK overtime is 10 seconds by default.

5-2
Data Transmission

NOTE
 The IP address for the analyzer is assigned statically. Ask your network
administrator for the IP address to avoid IP conflict.

 If the communication involves more than one subnet, ask your network
administrator for correct subnet mask and gateway.

 Ensure the wireless network card is properly inserted before setting up the
Wi-Fi network.

5.1.2 Serial Interface Communication


The 3008 serial interface communication uses the USB-serial method. Ensure the USB-serial
cable is properly connected before setup.

5.1.2.1 Network Types

Figure 5-3 Serial communication setup

5.1.2.2 Protocol Setup


Baud rate: the transmission rate for serial communication, which is 19200 by default;
Check Bit: parity bit, select Null by default;
Data Bit: 8 by default;
Stop Bit: 1 by default;

5-3
Data Transmission

Comm Protocol: HL7, 8ID and 10ID serial communication protocols are supported.

5.1.3 Transmission Mode


You can choose to select the functions based on your needs by tapping on the check boxes.
Auto Retransmit
The option can only be activated when the "ACK Synchronous Transmission" check box is
checked. When "Auto Retransmit" is selected, if ACK is not received in specified time, the
software will automatically re-send the data.
Auto Communicate
When the option is selected, software will automatically send the sample information and
analysis results to the LIS.
Transmit as Print Bitmap Data
When the option is selected, the histograms will be sent to LIS as printed data with white
background.
Histogram transmitted as
Select the histogram transmission method from the pull down list:
 Not to be transmitted
Histograms will not be transmitted when this option is selected.

 Bitmap
When this option is selected, the histograms will be transmitted in the format of bitmap to LIS.

 Data
When this option is selected, histograms will be transmitted to LIS as digital data in
Mindray-specified format and only can be reviewed with Mindray data management software

5-4
Data Transmission

5.2 Setup of Data Management Software


5.2.1 Communication Parameter Setup

Figure 5-4 Communication Parameter Setup on Data Management Software


As seen on above figure, the IP address and protocol should be set as the same as those of
the analyzer. The default IP address of the analyzer is 10.0.0.2. The port is fixed to be 5100.

5-5
Data Transmission

5.2.2 Communication Instrument Management

Figure 5-5 Communication Instrument Management with Data Management Software


Set the analyzer as server, and LIS and the data management software as the client. The
connection must be initialized from the client.

5.3 Troubleshooting for Communication Errors


 Physical connection

Check whether the network cable is properly connected; and whether the network physical
connection is correct.

 Communication setup

Check whether the network settings (including the communication setup for both analyzer
and LIS) are correct.

 Network firewall

To check whether there is a network firewall, open the network connection licenses for LIS,
data management software and the 5100 port.

5-6
6 Fluidics

6.1 Introduction to Fluidic Parts


6.1.1 Mindray valves
 Symbol:

2-way valve 3-way valve

 Appearance:

2-way valve 3-way valve

Spring pole

 Function:

2-way valve: to build up or cut off a passage. When power off, the passage from the inlet of
the valve to outlet is cut off; when power on, the passage is built up.
3-way valve: to switch among passages. When power off, the public end and the NO
(normally open) end are connected; when power on, the public end and the NO.(normally
open) end are connected.

 Note:

the operating voltage of Mindray valves is 12V, and maximal bearable pressure is 200KPa.
The internal movement of the valves is driven by electromagnet and the restoration is driven
by the spring, so it is recommended not put the valves power-on for too long. When the
solenoid valve is working, the spring pole will lower down, and it will rise to the initial position
when power off. You can touch the spring pole and feel the descending or ascending, in order
to determine whether it is in action.

6-1
Fluidics

6.1.2 LVM fluidic valve


 Symbol

Same as Mindray valves

 Appearance

3-way LVM fluidic valve

 Function:

same as of the Mindray valves. Compared with the 2-way valve, this valve bears higher
pressure and has a pump with smaller action volume; so it may adapts to more strict flow
control and greater temperature and pressure changes in

 Note:

the maximal bearable pressure of the LVM fluidic valve is 200KPa, and the CV of the flow is
about 0.03. The SV02 in the fluidic charts is LVM fluidic valve.

6.1.3 Linkage Syringe Device


 Symbol: SR

 Function:

the linkage syringe device, driven by a motor and a unit of driving assembly, consists of two
syringes: one with a high dispensing volume, the other with a low dispensing volume.

6-2
Fluidics

Table 6-1 Syringe specifications and functions

Name Specification Function

Low volume Aspirate and dispense blood sample of precise volume,


Full range 250ul
syringe and perform second aspiration
Dispense fixed volume of diluent to the WBC and RBC

High volume bathes, dispense liquid to the probe wipes, and supports
Full range: 10ml
syringe the cleaning of the interior and exterior of sample probe
as well as the baths.

6.1.4 Preheating bath


 Symbol

Preheating bath

 Appearance:

 Function:

dispense diluent and ensure the reaction temperature in the WBC bath.

6-3
Fluidics

6.1.5 Vacuum pump


 Symbol

 Appearance:

 Function:

to empty probe wipes, WBC bath and RBC bath; empty the vacuum chamber and build
vacuum pressure in the chamber

6.1.6 Air pump


 Symbol

 Appearance:

6-4
Fluidics

 Function: to provide pressure and generate bubbles

6.1.7 Sample probe


 Symbol

 Appearance: N/A

 Function:

provides a rigid, blood corrosion-resistant cavity for aspiration and dispensing of sample and
probe cleanser.

6-5
Fluidics

6.1.8 Probe wipes


 Symbol:

 Appearance:

Open-vial probe wipe

 Function:

provide a cavity where the interior and exterior walls of open-vial probe or piercing probe can
be cleaned by liquid flow; and the waste thus produced is also collected here.

6.1.9 Baths
 WBC bath: consists of front bath, back bath and an aperture. It is where the WBC
sample is mixed for analysis; supports the measurement of HGB and WBC.

 RBC bath: consists of front bath, back bath and an aperture. It is where the RBC sample
is mixed for analysis; supports the measurement of RBC/PLT.

NOTE
 RBC bath applies to only dual-bath analyzers, including BC-30s, BC-31s,
BC-20s, BC-21s, BC-30, BC-31, and 30e.

 The single-bath analyzers, including BC-20, BC-21, BC-10, BC-11, and BC-10e
are not configured with an RBC bath, and they use a WBC bath for the
measurement of HGB and WBC and then for the measurement of RBC/PLT.

6-6
Fluidics

 Vacuum chamber: where a stable vacuum is built and stored to support WBC and RBC
count (impedance method); and the front and back baths as well as the sample probe
wipe are cleaned.

 WBC isolation chamber: provides an air space to isolate exterior interference.

 RBC isolation chamber: provides an air space to isolate exterior interference.

NOTE
 An RBC isolation chamber applies to only dual-bath analyzers, including
BC-30s, BC-31s, BC-20s, BC-21s, BC-30, BC-31, and 30e. The single-bath
analyzers, including BC-20, BC-21, BC-10, BC-11, and BC-10e are not
configured with RBC isolation chambers.

6.1.10 Filters
Isolation chamber filters: filter the impurities and debris from the WBC bath.

6-7
Fluidics

6.2 Sample Dilution Flow Chart


The differences between the sample dilution flows of different models of new 3-DIFF series
(auto) hematology analyzers are as described in the following table:

Table 6-2 Comparison of the sample dilution flows of different models of new 3-DIFF
series (auto) hematology analyzers

Sample Dilution
WB Mode PD Mode
Flow Chart for
New 3-DIFF See 6.2.1 Whole Blood Mode (for See 6.2.3 Predilute Mode (for
series dual-bath Dual-Bath Analyzers). Dual-Bath Analyzers).
auto hematology
analyzers
(BC-30/31/30e/20
s/21s/30s/31s)

New 3-DIFF See 6.2.2 Whole Blood Mode (for See 6.2.4 Predilute Mode (for
series single-bath Single-Bath Analyzers Except Single-Bath Analyzers);
auto hematology BC-10e); The sample dilution flow chart of
analyzers The sample dilution flow chart of new 3-DIFF series single-bath
(BC-10/11/20/21) new 3-DIFF series single-bath auto hematology analyzers in PD
auto hematology analyzers in WB mode is consistent with the that of
mode is consistent with that of new 3-DIFF series dual-bath auto
new 3-DIFF series dual-bath auto hematology analyzers in PD
hematology analyzers in WB mode.
mode. New 3-DIFF series single-bath
New 3-DIFF series single-bath auto hematology analyzers adopt
auto hematology analyzers adopt only one bath. When the sample
only one bath. When the sample probe aspirates sample from the
probe aspirates sample from the bath for the second time, it stores
bath for the second time, it stores the sample in its sample probe
the sample in its sample probe until the WBC count is complete,
until the WBC count is complete, and then dispenses the stored
and then dispenses the stored sample to the bath for RBC and
sample to the bath for RBC and PLT count.
PLT count.

New 3-DIFF See 6.2.5 Whole Blood Mode (for The sample dilution flow chart of
series single-bath Single-Bath BC-10e Only). new 3-DIFF series single-bath

6-8
Fluidics

hematology The sample dilution flow chart of hematology analyzer (BC-10e) in


analyzer the new 3-DIFF series single-bath PD mode is the same as the
(BC-10e) hematology analyzer (BC-10e) in sample dilution flow chart of new
WB mode is consistent with that of 3-DIFF series single-bath auto
the new 3-DIFF series single-bath hematology analyzers in PD
auto hematology analyzers in PD mode.
mode. See 6.2.4 Predilute Mode (for
The differences lie in the sample Single-Bath Analyzers).
pre-dilution process outside the
analyzer.
For new 3-DIFF series single-bath
auto hematology analyzers in PD
mode, the sample is prediluted
manually outside the analyzer.
While, the BC-10e new 3-DIFF
series single-bath hematology
analyzer automatically aspirates
the blood sample and dispenses
the dilution together with the
sample for manual mixing outside
the analyzer.

6.2.1 Whole Blood Mode (for Dual-Bath Analyzers)


Compared to old models, the analyzer adopts a "single aspiration" method for whole blood
analysis. The basic procedure is as follows:
1. The sample probe aspirates 9uL of sample blood and ascends. In the meanwhile, the
exterior wall of the sample probe is cleaned.
2. The analyzer dispenses 9uL of sample and add dilution to the WBC bath, where they are
well mixed to prepare the diluted sample for WBC count and HGB measurement.
3. The sample probe ascends. In the meanwhile, its exterior wall is cleaned. When the
sample probe ascends to the probe wipe, it dispenses some of the diluent in it to clean
its interior wall.
4. The sample probe whirls and descends to the RBC bath, and dispenses dilution to the
bath.

6-9
Fluidics

5. The sample probe whirls and descends to the WBC to aspirate 23.1ul of diluted sample,
and then dispenses the sample and additional diluent to the RBC bath. The diluted
sample is used for RBC/PLT count.
6. The analyzer adds lyse to the WBC bath and mixes for reaction;
7. The analyzer runs the analysis;
8. When the analysis completes, the analyzer cleans the WBC and RBC baths, zaps the
apertures, and releases the vacuum pressure.
The dilution procedure is illustrated as shown in Figure 6-1.

Aspirate 9ul
sample

Diluent
1.55ml

Dilution ratio: Aspirate 23.1ul diluted sample


1:173.22

Lyse 310ul Diluent 2.2ml

WBC sample RBC sample


Dilution ratio 1:305.2 Dilution ratio 1:16497.3

Figure 6-1 Dilution under whole blood mode (for dual-bath analyzers)

6.2.2 Whole Blood Mode (for Single-Bath Analyzers Except

BC-10e)
Compared to old models, the analyzer adopts a "single aspiration" method for whole blood
analysis. The basic procedure is as follows:
1. The sample probe aspirates 9uL of sample blood and ascends. In the meanwhile, the

6-10
Fluidics

exterior wall of the sample probe is cleaned.


2. The analyzer dispenses 9uL of sample and add dilution to the bath, where they are well
mixed to prepare the diluted sample for WBC count and HGB measurement.
3. The sample probe ascends. In the meanwhile, its exterior wall is cleaned. Where the
sample probe ascends to the probe wipe, it dispenses some of the diluent in it to clean
its interior wall.
4. The sample probe descends to the bath to aspirate 23.1ul of diluted sample, and saves it
in the sample probe for RBC/PLT count.
5. The analyzer adds lyse to the bath and mixes for reaction;
6. The analyzer runs the analysis;
7. When the analysis completes, the analyzer cleans the bath and zaps the apertures.
8. The analyzer adds initial volume to the bath and adds the aspirated sample that stored in
the sample probe to the bath to well mix them.
9. The sample probe ascends. Its interior and exterior walls are cleaned.
10. The analyzer runs the RBC count and PLT count.
11. When the analysis completes, the analyzer cleans the bath, and releases the vacuum
pressure.
The dilution procedure is illustrated as shown in Figure 6-2:

Aspirate 9ul
sample

Diluent
1.55ml

Dilution ratio: Aspirate 23.1ul diluted sample


1:173.22

First measure Then measure


WBC/HGB RBC/PLT

Lyse 310ul Diluent 2.2ml

WBC sample RBC sample


Dilution ratio 1:305.2 Dilution ratio 1:16497.3

Figure 6-2 Dilution under whole blood mode (for single-bath analyzers)

6-11
Fluidics

20ul of whole
blood sample

700ul of diluent

1:36 dilution

198ul

1352ul of
diluent

37.7ul
1:281.82
dilution

310ul of lyse 2.2ml of diluent

1:500.8 dilution for 1:16445.7 dilution for


WBC measurement RBC measurement

Figure 6-3 Dilution under whole blood mode

6.2.3 Predilute Mode (for Dual-Bath Analyzers)


The analysis under predilute mode contains 3 function-based sequences: diluent dispensing
sequence, cleaning (open-vial) sequence and analysis sequence. The basic procedure is as
follows:
1. The sample probe dispenses 700uL of diluent to a centrifugal tube. Then, manually add
20uL of the capillary blood sample to the centrifugal tube. Well mix the sample.
2. The sample probe aspirates and dispenses 198uL of the prepared sample to the WBC
bath, and adds diluent to the bath to fairly mix with the sample for WBC and HGB
measurement.
3. The sample probe ascends and cleans its interior and exterior walls.
4. The sample probe descends to the WBC bath to aspirate 37.7ul of diluted sample, and
then dispenses the sample to the RBC bath and adds diluent to the RBC bath. The
further diluted sample is used for RBC/PLT count.
5. The analyzer adds lyse to the WBC bath and mixes for reaction;
6. The analyzer runs the analysis;

6-12
Fluidics

7. When the analysis completes, the analyzer cleans the WBC and RBC baths, zaps the
apertures, and releases the vacuum pressure.
You can see the analysis procedures under whole blood and predilute mode are basically the
same except for the sample aspiration procedure and the sample dispensing procedure to
WBC bath.
The dilution procedure is illustrated as shown in Figure 6-4:

Capillary blood
sample 20ul

Configure the
Diluent 700ul dilution
manually
Dilution ratio:
1:36
Aspirate
198ul
Diluent sample
1352ul

Aspirate 37.7ul diluted sample


Dilution ratio
1:281.82

Lyse 310ul Diluent 2.2ml

WBC sample RBC sample


Dilution ratio 1:500.8 Dilution ratio 1:16445.7

Figure 6-4 Dilution under predilute mode (for dual-bath analyzers)

6.2.4 Predilute Mode (for Single-Bath Analyzers)


The analysis under predilute mode contains 3 function-based sequences: diluent dispensing
sequence, cleaning (open-vial) sequence and analysis sequence. The basic procedure is as
follows:
1. The sample probe dispenses 700uL of diluent to a centrifugal tube. Then, manually add
20uL of the capillary blood sample to the centrifugal tube. Well mix the sample.
2. The sample probe aspirates and dispenses 198uL of the prepared sample to the bath, and
adds diluent to the bath to fairly mix with the sample for WBC and HGB measurement.

6-13
Fluidics

3. The sample probe ascends and cleans its interior and exterior walls.
4. The sample probe descends to the bath to aspirate 37.7ul of diluted sample, and then
saves it in the sample probe for RBC/PLT count.
5. The analyzer adds lyse to the bath and mixes for reaction;
6. The analyzer runs the WBC count and HGB measurement;
7. When the analysis completes, the analyzer cleans the bath and zaps the apertures.
8. The analyzer adds initial volume to the bath and adds the aspirated sample that stored in
the sample probe to the bath to well mix them.
9. The sample probe ascends. Its interior and exterior walls are cleaned.
10. The analyzer runs the RBC count and PLT count.
11. When the analysis completes, the analyzer cleans the bath, and releases the vacuum
pressure.
The dilution procedure is illustrated as shown in Figure 6-5:

Capillary blood
sample 20ul

Configure the
Diluent 700ul dilution
manually
Dilution ratio:
1:36
Aspirate
198ul
Diluent sample
1352ul

Aspirate 37.7ul diluted sample


Dilution ratio
1:281.82

First measure
Then measure
WBC/HGB
RBC/PLT

Lyse 310ul Diluent 2.2ml

WBC sample RBC sample


Dilution ratio 1:500.8 Dilution ratio 1:16445.7

Figure 6-5 Dilution under predilute mode (for single-bath analyzers)

6-14
Fluidics

6.2.5 Whole Blood Mode (for Single-Bath BC-10e Only)


The BC-10e is a single-bath hematology analyzer. The analysis under WB mode (applies to
BC-10e only) contains 3 function-based sequences: sample aspiration sequence, whole
blood sample dispensing sequence, and analysis sequence. The basic procedure is as
follows:
1. The analyzer aspirates 20uL of sample blood through the sample probe, adds the
sample with 700uL of dilution, and then dispenses them in a centrifugal tube. Manually
well mix the sample.
2. The analyzer aspirates and dispenses 198uL of the prepared sample to the bath, and
adds diluent to the bath to fairly mix with the sample for WBC and HGB measurement.
3. The sample probe ascends. Its interior and exterior walls are cleaned.
4. The sample probe descends to the bath to aspirate 37.7ul of diluted sample and saves it
in the sample probe for RBC/PLT count.
5. The analyzer adds lyse to the bath and mixes for reaction;
6. The analyzer runs the WBC count and HGB measurement;
7. When the analysis completes, the analyzer cleans the bath and zaps the apertures.
8. The analyzer adds initial volume to the bath and adds the aspirated sample that stored in
the sample probe to the bath to well mix them.
9. The sample probe ascends. Its interior and exterior walls are cleaned.
10. The analyzer runs the RBC count and PLT count.
11. When the analysis completes, the analyzer cleans the bath, and releases the vacuum
pressure.
You can see the analysis procedures of BC-10e under WB) mode and under PD mode are
basically the same except for the sample dilution procedure. In PD mode, the sample is
prediluted manually. In WB mode, the analyzer aspirates the sample and then dispenses the
sample with dilution to a centrifugal tube for manual mixing.
The dilution procedure of BC-10e under WB mode is illustrated as shown in Figure 6-6:

6-15
Fluidics

20ul of whole
blood sample

700ul of diluent

1:36 dilution

198ul

1352ul of
diluent

37.7ul
1:281.82
dilution

310ul of lyse 2.2ml of diluent

1:500.8 dilution for 1:16445.7 dilution for


WBC measurement RBC measurement

Figure 6-6 Dilution under whole blood mode

6.3 Introduction to Fluidic Channels


This section describes the fluidic channels used in the new 3-DIFF series analyzers.
For details on the function of the fluidic channels in the corresponding sample dilution flow,
refer to 6.2 Sample Dilution Flow Chart.

6.3.1 Fluidic Channels for Dual-Channel Analyzers


A dual-channel analyzer has two baths: the WBC bath is used for WBC/HGB count, and the
RBC bath is used for RBC/PLT count.

6.3.1.1 WBC/HGB Channel


 Reagent used:

1. M-30PCFL cyanide-free lyse (break out RBCs and PLTs and 3-differentiate WBCs
based on cell size);
2. M-30PD diluent (used for cleaning, and providing appropriate environment for reaction

6-16
Fluidics

and measurement)

 Measurement principle: impedance method (for WBC count); colorimetric method (for
HGB measurement)

 Measurement parameters: WBC and HGB

 Output graph: WBC histogram

 Dilution ratio: 1:305.2 (whole blood mode); 1:500.8 (predilute mode)

 Aperture diameter: 100um

 Sample analysis duration: 10s

 Function description: 9ul blood sample and 1.55ml diluent are mixed in the WBC bath
to get diluted sample; of which 23.1ul is dispensed to the RBC bath, and the remain
diluted sample is mixed with 0.31ul of lyse. The sample solution after full reaction is then
sucked into the back bath by vacuum pressure in the vacuum chamber. The cells are
counted when they pass the aperture. Sample volume is calculated based on analysis
time.

6.3.1.2 RBC/PLT channel


 Reagent used: diluent (dilution, cleaning, providing conductive environment and
processing cell sizes)

 Measurement principle: impedance method

 Measurement parameters: RBC and PLT

 Graphics: RBC histogram; PLT histogram

 Dilution ratio: 1:16497.3 (whole blood mode); 1:16445.7 (predilute mode)

 Aperture diameter: 70um

 Sample analysis duration: 10s

 Function description: the sample probe aspirates 23.1ul of the diluted sample (dilution
rate: 1:173.22) from the WBC bath, and dispenses the sample as well as additional
diluent to the RBC bath, where the sample and the diluent are further mixed with existing
initial volume of diluent (in all 2.2 ml diluent is used in this process) to get a dilution of 1:
16497.3. After full mixing and reaction, the sample solution is then sucked into the back
bath by vacuum pressure in the vacuum chamber. The cells are counted when they pass
the aperture. Sample volume is calculated based on analysis time.

6-17
Fluidics

6.3.2 Fluidic Channels for Single-Channel Analyzers Except

BC-10e
A single-channel analyzer has only one bath, which is used for WBC/HGB count first and then
for RBC/PLT count.

6.3.2.1 WBC/HGB Channel


 Reagent used:

1. M-30PCFL cyanide-free lyse (break out RBCs and PLTs and 3-differentiate WBCs
based on cell size);
2. M-30PD diluent (used for cleaning, and providing appropriate environment for reaction
and measurement)

 Measurement principle: impedance method (for WBC count); colorimetric method (for
HGB measurement)

 Measurement parameters: WBC and HGB

 Output graph: WBC histogram

 Dilution ratio: 1:305.2 (whole blood mode); 1:500.8 (predilute mode)

 Aperture diameter: 80um

 Sample analysis duration: 10s

 Function description: 9ul blood sample and 1.55ml diluent are mixed in the WBC
bathto get diluted sample; of which 23.1ul is aspirated and stored for RBC/PLT count,
and then 0.31ul lyse is added in the WBC bath and mixed. The sample solution after full
reaction is then sucked into the back bath by vacuum pressure in the vacuum chamber.
The cells are counted when they pass the aperture. Sample volume is calculated based
on analysis time.

6.3.2.2 RBC/PLT Channel


 Reagent used: diluent (dilution, cleaning, providing conductive environment and
processing cell sizes)

 Measurement principle: impedance method

 Measurement parameters: RBC and PLT

 Graphics: RBC histogram; PLT histogram

 Dilution ratio: 1:16497.3 (whole blood mode); 1:16445.7 (predilute mode)

 Aperture diameter: 80um

 Sample analysis duration: 10s

6-18
Fluidics

 Function description: After the WBC/HGB count is completed, the sample probe
dispenses the stored 23.1ul of the diluted sample (dilution rate: 1: 173.22) as well as
additional diluent to the WBC bath, where the sample and the diluent are further mixed
with existing initial volume of diluent (in all 2.2 ml diluent is used in this process) to get a
dilution of 1:16497.3. After full mixing and reaction, the sample solution is then sucked
into the back bath by vacuum pressure in the vacuum chamber. The cells are counted
when they pass the aperture. Sample volume is calculated based on analysis time.

6.3.3 Fluidic Channels for Single-Bath BC-10e


BC-10e is a single-channel analyzer. It has only one bath, which is used for WBC/HGB count
first and then for RBC/PLT count.

6.3.3.1 WBC/HGB Channel


 Reagent used: 1) M-30PCFL cyanide-free lyse (break out RBCs and PLTs and
3-differentiate WBCs based on cell size); 2) M-30PD diluent (used for cleaning, and
providing appropriate environment for reaction and measurement)

 Measurement principle: impedance method (for WBC count); colorimetric method (for
HGB measurement)

 Measurement parameters: WBC and HGB

 Output graph: WBC histogram

 Dilution ratio: 1:500.8 (whole blood mode and predilute mode)

 Aperture diameter: 80um

 Sample analysis duration: 10s

 Function description: The sample probe aspirates 20ul of blood sample, and then
dispenses the sample together with 700uL of dilution. Manually well mix the sample. The
sample probe aspirates 198ul of the sample, adds the sample with 1.35ml diluent, and
then aspires and stores 37.7uL of the sample mixture for RBC/PLT count. Then, the
sample probe adds 0.31ul of lyse in the WBC bath and mix them. The sample solution
after full reaction is then sucked into the back bath by vacuum pressure in the vacuum
chamber. The cells are counted when they pass the aperture. Sample volume is
calculated based on analysis time.

6.3.3.2 RBC/PLT Channel


 Reagent used: diluent (dilution, cleaning, providing conductive environment and
processing cell sizes)

 Measurement principle: impedance method

 Measurement parameters: RBC and PLT

 Graphics: RBC histogram; PLT histogram

6-19
Fluidics

 Dilution ratio: 1:16445.7 (whole blood mode and predilute mode)

 Aperture diameter: 80um

 Sample analysis duration: 10s

 Function description: After the WBC/HGB count is completed, the sample probe
dispenses the stored 37.7ul of the diluted sample (dilution rate: 1:281.82) as well as
additional diluent to the WBC bath, where the sample and the diluent are further mixed
with existing initial volume of diluent (in all 2.2 ml diluent is used in this process) to get a
dilution of 1:16445.7. After full mixing and reaction, the sample solution is then sucked
into the back bath by vacuum pressure in the vacuum chamber. The cells are counted
when they pass the aperture. Sample volume is calculated based on analysis time.

6.4 Sample Volume


The sample aspiration volume required for single-bath analyzers and that for dual-bath
analyzers in the same sample mode are the same.

Table 6-3 Sample Volume

WB Mode PD Mode
3-DIFF series single-bath auto
hematology analyzers ≤ 9μL ≤ 20μL
(BC-10/11/20/21)

3-DIFF series dual-bath auto


hematology analyzers ≤ 9μL ≤ 20μL
(BC-30/31/30e/20s/21s/30s/31s)

3-DIFF series single-bath


≤ 9μL ≤ 20μL
hematology analyzer (BC-10e)

6.5 Temperature of Fluidics


6.5.1 Introduction to the Thermo System
The thermo system of this analyzer refers to the diluent heating module, which ensures the
best reaction temperature for the WBC bath.
The diluent heating system consists of the diluent temperature detection unit and the
preheating unit. The heating control of the heating units is detected and managed by the
diluent temperature sensor and preheating sensor.
The temperature ranges at various detection positions are as follows:

6-20
Fluidics

Name Temperature range (°C)


Diluent detection unit temperature 5-45
Floating value, determined by diluent temperature.
Preheating unit temperature
[Target temperature] -2, Target temperature +3]

6.5.2 Diluent Heating System

Diluent Temperature
Detection Unit

Reaction Bath
Temperature
J27 Detection Unit
PIN3 Temperature Preheating
Main Control Switch Assembly
Board
J11
PIN4

Diluent temperature detection unit structure

 Symbol:

 Appearance:

 Function:

a. check whether the diluent temperature fall in the range of [10°C,40°C]. When it is out of
the range, the analyzer will stop working and gives out alarm; b. provide diluent temperature
needed for the calculation of bath temperature.

6-21
Fluidics

6.6 Introduction to Sequences


6.6.1 Analysis Sequence under Whole Blood Mode
This section introduces the sampling procedure, analysis procedure as well as the cleaning
procedure. For the sample dilution procedure, see section 6.2.

6.6.1.1 Sampling Procedure


For dual-bath analyzers:
The sample probe workflow is shown in Figure 6-7. The sample probe workflow can be
divided into following steps:

a) Aspiration
① Aspirate 9ul of sample blood.

b) First dilution
① Sample probe aspirates required volume of sample, and moves from the tube;
② Sample probe whirls to the position above the WBC bath;
③ Sample probe descends to the WBC bath and dispenses 9ul of sample.

c) Dispense initial volume to RBC bath


① Sample probe ascends from the WBC bath to the probe wipe where its interior
and exterior walls are cleaned;
② Sample probe whirls to the position above the RBC bath.
③ Sample probe descends to the RBC bath, and dispenses initial volume to the
bath.

d) Aspirate sample dilution from WBC bath


① Sample probe ascends from the RBC bath;
② Sample probe whirls to the position above the WBC bath;
③ Sample probe descends into the WBC bath and aspirate 23.1ul of sample after
first dilution.

e) Second dilution in RBC bath


① Sample probe aspirates required volume of sample, and moves from the WBC
bath;
② Sample probe whirls to the position above the RBC bath;
③ Sample probe descends into the RBC bath and dispenses the sample dilution.
④ Sample probe returns to its original position.

6-22
Fluidics

③ ①
WBC

Diluent Sample
a) b)

② ②
③ ① ③

RBC WBC RBC WBC

Diluent First
base c) d) dilution


③ ①
RBC WBC

Second
dilution e)

Figure 6-7 Sampling and dispensing process (for dual-bath analyzers)

For single-bath analyzers except BC-10e:


The sample probe workflow is as shown in Figure 6-8. The sample probe workflow can be
divided into following steps:
a) Aspiration
① Aspirate 9ul of sample blood.

b) First dilution

6-23
Fluidics

① Sample probe aspirates required volume of sample, and moves from the tube;
② Sample probe whirls to the position above the bath;
③ Sample probe descends to the bath and dispenses 9ul of sample.
④ Sample probe ascends from the bath to the probe wipe where its interior and
exterior walls are cleaned;

c) Aspirate sample dilution from the bath


① Sample probe descends into the bath and aspirates 23.1ul of sample after first
dilution.
② After the sample probe aspirates required volume of sample, it ascends above
the bath and waits until the WBC/PLT count is complete;

d) Second dilution in bath


① After the WBC/PLT count is complete, the sample probe descends to the bath,
dispenses its stored sample dilution;
② Sample probe returns to its original position.

③ ①
WBC

Diluent Sample
a) b)

① ② ②

RBC
WBC count
count
First
Second
dilution
c) d) dilution

Figure 6-8 Sampling and dispensing process (for single-bath analyzers except BC-10e)

6-24
Fluidics

For single-bath analyzer BC-10e:


©The sample probe workflow is as shown in Figure 6-8. The sample probe workflow can be
divided into following steps:
a) Aspiration
① Sample probe aspirates 20uL of sample blood.

b) Diluent dispensing
① The sample probe adds the sample with 700uL of dilution, and then dispenses
them in a centrifugal tube.

c) First dilution
① Sample probe aspirates required volume of sample, and moves from the tube;
② Sample probe whirls to the position above the bath;
③ Sample probe descends to the bath and dispenses 198ul of sample.
④ Sample probe ascends from the bath to the probe wipe where its interior and
exterior walls are cleaned;

d) Aspirate sample dilution from the bath


① Sample probe descends into the bath and aspirates 37.7ul of sample after first
dilution.
② After the sample probe aspirates required volume of sample, it ascends above
the bath and waits until the WBC/PLT count is complete;

e) Second dilution in bath


① After the WBC/PLT count is complete, the sample probe descends to the bath
and dispenses its stored sample dilution;
② Sample probe returns to its original position.

6-25
Fluidics


Sample
Sample centrifugal
a) tube b)

① ①
WBC

Diluent centrifugal
tube
c)

① ① ①

RBC
WBC coun
count t
First Secon
dilution d
e) dilution
d)

Figure 6-9 Sampling and dispensing process (for single-bath analyzer BC-10e

6-26
Fluidics

6.6.1.2 Analysis Procedure


For dual-bath analyzers:
After the sample aspiration and dispensing procedure, the analysis will start. See Figure 6-10
for the procedure. Build in the vacuum chamber a -30KPa vacuum which presses the sample
solution in the front baths of WBC and RBC baths to flow through the apertures to the back
baths. The sample solution in both the two back baths will then flow to the vacuum chamber
in the direction indicated by the red arrows.

T23
WBC RBC

T24

J3-T34-J4
J1-T33-J2

T25

C6 C7
T35 T36

Isolation Chamber 1 Isolation Chamber 2

SV04
T26

C8
T27

T28
T55 C24
T29

C21
VC
T53

Transducer

Figure 6-10 Analysis Procedure (for dual-bath analyzers)

6-27
Fluidics

For single-bath analyzers:


After the sample aspiration and dispensing procedure, the analysis will start. See Figure 6-11
for the procedure.
After the sample aspiration and dispensing procedure, the analysis will start. See Figure 6-11
for the procedure. Build in the vacuum chamber a -30KPa vacuum which presses the sample
solution in the front baths to flow through the apertures to the back baths. The sample
solution in the back bath will then flow to the vacuum chamber in the direction indicated by
the red arrows.

PS

T27
T23
T26
T21 C12

T25
T22 T24
WBC T29

Figure 6-11 Analysis Procedure (for single-bath analyzers)

6.6.1.3 Cleaning Procedure


For dual-bath analyzers:
As the analyzer only has two baths, the cleaning procedure is comparably simple :
1. Empty and prime the WBC bath;
2. Zap apertures, clean the back baths;
3. Empty and prime the RBC bath;
4. Clean the back baths again;
5. Empty and prime the WBC bath.

For single-bath analyzers:


As the analyzer only has only one bath, the cleaning procedure is required after both WBC
count and RBC count:
After the WBC count is complete, the cleaning procedure is as follows:
1. Empty and prime the bath;
2. Zap apertures, clean the back baths;
3. Empty and prime the bath;

6-28
Fluidics

After the RBC count is complete, the cleaning procedure is as follows:


1. Empty and prime the bath;
2. Zap apertures, clean the back baths;
3. Empty and prime the bath;

6.6.2 Analysis Sequence under Predilute Mode


Analysis sequence under predilute mode for a large part is the same as that of whole blood
mode except for the sample and the diluent consumption.

6.6.3 Introduction to Major Maintenance Sequences


6.6.3.1 Probe Cleanser Maintenance (Shutdown Sequence)
The probe cleanser maintenance during the shutdown process involves the following parts:
the front and back baths of WBC and RBC baths, back bath tubing, sample probe as well as
sampling tubing.
The analyzer will perform "enhanced" probe cleanser maintenance after every 300 analyses.
Compared with normal probe cleanser maintenance, the enhanced process uses a longer
probe cleanser soak time (1 minute longer than normal maintenance).
Tap "Fluidic" on the "Maintenance" screen, the analyzer will perform enhanced probe
cleanser maintenance.

6.6.3.2 Cleaning Procedure during Startup


The fluidic actions during the startup consist of the following parts:
1. Initialization of fluidic components: initialize the aspiration module and syringe module,
build and release vacuum.
2. Overall cleaning: clean all the tubes, parts and components of the analyzer. Remove
bubbles in the diluent preheating bath. No lyse is consumed.
3. Background check: under whole blood mode.
If the background does not pass, the analyzer will perform the overall cleaning procedure one
more time, and then check the background again.
When the analyzer starts after abnormal shutdown, it will perform the overall cleaning
procedure twice.

6-29
Fluidics

6.6.3.3 Standby
The analyzer enters "Standby" mode when there is no action performed for 10~90 minutes
(configurable, 15 minutes by default) When the analyzer is standby, you can still perform
operations not involving fluidic actions.
Exit standby status1: standby for less than 1 hour
Clean the exterior wall of sample probe and WBC bath, re-build isolation bubbles. The
process does not consume lyse.
Exit standby status1: standby for more than 1 hour, but no longer than 3 hours.
Clean both the exterior and interior walls of sample probe, clean the WBC and RBC baths,
re-build isolation bubbles. The process does not consume lyse.
Exit standby status3: standby for more than 3 hours, but no longer than 12 hours.
Equivalent of overall cleaning; all the tubing, parts and components will be cleaned, remove
bubbles in the diluent preheating bath, remove the crystallization and bubbles at the diluent
inlet.
Exit standby status4: standby for more than 12 hours.
Base on Exit standby status3, increase to remove bubbles in lyse tubing.

6-30
7 Hardware System
The hardware system not only consists of power board, main control board, indicator board,
touch screen control board and liquid detection board, but also the electrified drives and
components (e.g. motors, valves, pumps, sensors, screens, and power filters), as well as the
cables connecting different boards or connecting boards and components.

7.1 Hardware System Function Block Diagram


The function block diagram of the hardware system is shown as shown in Figure 7-1.
The hardware system consists of 5 major modules: system power, data flow channel, main
control system, drive parts and peripheral interfaces.

Signal
preconditioning Embedded
Impedance channel

Colorimetry channel

Signal collection platform of the


Digital processing main control

Monitored signal Universal USB interface


RBC bath external interface Network interface
Data flow
LCD screen
User input and Touch screen
WBC
Structure and output Aspirate key
bath
interconnection Recorder

Large memory
Vacuum building
Reaction bath
Power driving

temperature
temperature

User interaction
detection
Diluent
control

Aspiration Motor driving Power switch


module Sensor detection

Syringe Motor driving


Sensor detection Net power
assembly Net power
switching &
preconditioning
Liquid detection Liquid detection
assembly Power supply sub-
Control flow system

Figure 7-1 Function block diagram of the hardware system

The functions of each module are shown below:


1. System power: provides power of required specifications to all boards, parts and devices
2. Data flow channel: detects, conditions, amplifies, collects and pre-processes signals.
3. Main control system: collects and processes data, displays results and stores sample
information. Besides, main control system acts as the control and management center

7-1
Hardware System

which controls and responds to all other components and devices.


4. Drives/detectors: control valves, pumps and motors; monitors the photocouplers and
other important parameters; collects information during analysis and sends out flags.
5. Peripheral interfaces: include interfaces to display/touch screen, USB ports (connecting
to printer, keyboard, and barcode scanner) and Ethernet interface. Besides, peripheral
interfaces also include those to the working status indicator and the [Aspirate] key.

7.2 Electrical Connection Diagram


The electrical connection of the analyzer is shown as below:
Heating
Temperature
membrane
Waste sensor

floater Temperature control


Vacuum Preheating bath
pump
Aperture HGB
HGB control
PD LED assembly
and signal WBC bath assembly

Aperture
RBC bath
Stepping Aperture driving
motor and impedance signal

Wired network
Sensor interfaceX1

Syringe assembly

Sensor X3 USB interfaceX4

Stepping
motor X2
Aspiration module Recorder

Electromagnetic
valveX12
Aspirate key
Liquid detection
board Indicator board
LCD screen data
P12V
P24V LCD screen
D5V Backlight control (touch
A12V_P/N screen)
Touch
Power D5V screen Touch screen
assembly P12V data control board
Front cover assembly
Main control board

Figure 7-2 Electrical connection of the analyzer

Note: The RBC bath applies to BC-30s/31s/20s/21s/30/31/30e only. BC-20/21/10/11/10e is


not configured with the RBC bath.
For a more detailed electrical connection diagram, please see Appendix A-1.

7-2
Hardware System

7.3 Main Control Board


7.3.1 Overview
The main control board consists of analog module, digital module and power drive module;
among which, the analog module conditions and amplifies the signals from the impedance
channel and HGB channel as well as other analog signals like monitoring voltages, and
converts them into digital signals through the A/D converter. The digital module is responsible
for the drive and control of mechanical parts as well as the processing, outputting and
communication of data. The power drive follows the instruction of CPU to drive the motors,
valves, pumps and heaters.
All models of the new 3-DIFF series (auto) hematology analyzers use the same main control
board. The SD card of an analyzer carries the analyzer type and calibration information.
Therefore, different models of analyzers are configured with SD cards of different
configuration information. When a main control board is faulty, it can be replaced with a new
main control board but can only use its original SD card.
For troubleshooting information of the main control board, please refer to section 7-2.

7.3.2 Components
The structure of the main control board is illustrated in Figure 7-3. It mainly consists of digital
circuits and several ADC circuits for A/D conversion. The digital circuit module is responsible
for processing data, saving and outputting results. Furthermore, as the core of the main
control board and even the whole hardware system, it takes the management and
communication job. ADC circuits uses A/D converters to convert analog value monitoring
signals (like WBC, RBC, PLT counts etc.) to digital signals.
The control function of the main control board is realized with a "CPU+FPGA" structure. The
main control board mainly provides the following functions:
 A/D conversion
 Data processing
 Peripheral interface enabling
 Control interface extending

7-3
Hardware System

EEPRO
DDR2 SDRAM
M

PHY Ethernet interface


Analog USB-
USB interface
circuit HUB
AD

CPU
C Touch screen

FPGA
(RBC/WBC/HGB/monitor)

TFT screen

Driving Indicator board


module Recorder
(Motors/valves, pumps/heating)

JTAG, configuration Digital Real-time SDCARD


chip power clock

Figure 7-3 The structure of the main control board


Introduction
1. Drive module
Consists of motor drive and power component drive

2. A/D conversion
Converts analog signals to digital signals which can be processed by FPGA or CPU.

3. Data processing
FPGA filters the digital signals collected during A/D sampling and saves the particular
parameters. It then transmits the data to CPU by various means (like interrupt control) for
further processing. The processed data will be displayed on the LCD screen.

4. Peripheral interface enabling


CPU module acts as the platform for software operation . It also enables the peripheral
interfaces like indicator board interface, LCD display interface, Ethernet interface, USB
printer interface, and the ports to barcode scanner, keyboard and USB. Besides, it provides a
JTAG interface for FPGA online programing, and a CPU debugging interface.

5. Control interface extending


Provide control logic and interfaces to the LCD screen, SD card, touch screen and recorder.

7-4
Hardware System

Figure 7-4 Sockets on the main control board

 Definition of sockets

The main control board has 13 sockets. See Table 7-1 for the socket functions; see Figure
7-4 for their positions.

7-5
Hardware System

Table 7-1 Functions of sockets on the main control board


Sockets Function PIN function description Description
J4 Socket to PIN1: 12V /
analog circuit PIN2: 12V_N
PIN4: AC120V_A
PIN5: AC120V_B
PIN3,PIN6: GND

J5 Socket to PIN1,2: 5V /
digital circuit PIN3,4: GND

J6 Socket to PIN1,2: 24V Control motors, valves, pumps,


power circuit PIN3,4: 12V heaters and LCD backlight
PIN5~8: GND
J7 Socket to / /
sampling motor

J8 Socket to / /
syringe motor

J9 Socket to valve / /
and pump drive

J11 Socket to PIN1,3: 24V /


heaters

J12 Socket to / /
photocoupler
signals

J14 Socket to liquid PIN2: reagent detection


detection board signals
PIN5: diluent detection
signals
PIN1,6: GND
PIN3,4: 3.3V

J15 Socket to PIN1: [Aspirate] key /


[Aspirate] key signals
and waste PIN3: floater signals
detection PIN2,4: GND
floater
J16 Socket to / /

7-6
Hardware System

printer interface

J19 Socket to / /
keypad
interface

J24 Socket for LCD / /


signal
processing

J25 Socket for LCD / /


backlight
control

J26 Socket to touch / /


screen
pinboard

J27 Socket to PIN1,3: temperature /


temperature sensors
sensor PIN2,4: GND

J28 Socket to HGB / /


assembly

J29 Socket for RBC / Used for dual-bath analyzers


signal only.
processing

J30 Socket for / /


WBC signal
processing

7-7
Hardware System

7.3.3 Debugging and Troubleshooting


All the configurable parameters on the main board can be adjusted to command. Adjust the
parameters on the software screens.

7.3.3.1 LED Indicator Functions


The functions of the LED indicators on the main control board are defined in Table 7-2:

Table 7-2 Functions of LED indicators on the main control board

Possible causes when the LED does


Indicators Functions
not light

D1, D2 Network socket indicator: when Network not connected, network cable
the network cable is properly damaged, error with main control board
connected to the PC, D2 lights on,
while D1 flickers

D5~D12 USB indicators. D10 and D12 Power board error, DC circuit cable
always on; D6~D9 respectively error, and main control board error.
corresponds to the 4 USB
interfaces and only lights on when
a USB device is inserted.

D13~D18 Motor indicator; flicker when a Power error, main control board error
motor is moving

D21 FPGA Operation indicator CPU buckle plate error, SD card error,
main control board error

D28 -5V power indicator Power board error, DC circuit cable


error, main control board short-circuited

D26 12V power indicator Power board error, DC circuit cable


error, main control board short-circuited
D27 24V power indicator Power board error, DC circuit cable
error, main control board short-circuited
D28 -5V power indicator Power board error, DC circuit cable
error, main control board short-circuited

D30 -12V power indicator Power board error, DC circuit cable


error, main control board short-circuited

D31 12V power indicator Power board error, DC circuit cable


error, main control board short-circuited

7-8
Hardware System

7.3.3.2 Test Points


The functions of the test points on the main control board are listed in Table 7-3.
If power errors are suspected, first pull out all other cables other than power cables to rule out
the possibility of any short-circuited peripheral.

Table 7-3 Functions of test points on the main control board

Test
No. Introduction Troubleshooting
Points

1 TP3 Touch screen /


interrupt signal

2 TP4 Touch screen /


reset signal

3 TP5 Digital ground /


cable

4 TP7 Backlight enabling Voltage is 3.3V; main control board error


signal

5 TP8 Backlight PWM Voltage is out of the range of 0.7V~1.2V; main


signal control board error

6 TP9 Backlight GND /


signal

7 TP61 5V voltage Voltage is not 5V; main control board or power


monitoring point board error

8 TP69 VDD 3.3V voltage Voltage is not 3.3V; main control board or power
monitoring point board error

9 TP70 VDD18 1.8 V Voltage is not 1.8V; main control board or power
voltage board error
monitoring point

10 TP71 VDD12 1.2 V Voltage is not 1.2V; main control board or power
voltage board error
monitoring point

11 TP80 VDD25 2.5 V Voltage is not 2.5V; main control board or power
voltage board error

7-9
Hardware System

monitoring point

12 TP84 Analog ground /

13 TP87 12V voltage Voltage is not 12V; main control board or power
monitoring point board error (ground for the voltage is not GND, but
J68_PIN2)

14 TP108 ADC U29 5.0V Voltage is not 5.0V; main control board error
reference voltage

15 TP109 ADC U30 5.0V Voltage is not 5.0V; main control board error
reference voltage

16 TP110 ADC U28 2.5V Voltage is not 2.5V; main control board error
reference voltage

7-10
Hardware System

7.4 Power Assembly


7.4.1 Overview
The power assemblies of the new 3-DIFF analyzers are updated in year 2017.
The new power assemblies are backward compatible and can be used to replace original
power assemblies.
The differences between the original power assemblies and the new power assemblies are
described as below:

Difference Original Power Assembly New Power Assembly

Appearance of Power Unit One big square board One big square board and
one small square board

Number of Consisting Power One Two (the Power Supply PCBA


Boards and the Power Board PCBA
for Burning)

They can be distinguished from each other from their appearance and number of consisting
power boards.

7.4.2 Overview of the Original Power Assembly


The power board provides the analyzer with 6 units of reliable power output, including D5V,
A+12V, A-12V, AC120V. P24V and P12V.
Definition of interfaces
There are 6 interfaces to external systems on the power board; among which J1 to J4 are
sockets, L and N are AC input connecting cables, wiring from the side of the board to the
sockets; the inverter mini-board is directly inserted to the main board through a socket. The
interface positions on the power board are illustrated as below:

7-11
Hardware System

Figure 7-5 Interface connections on the power board

The functions of the interfaces are listed below:

Table 7-4 AC input connection cable

PIN Definition
L Live line terminal to AC

N Zero line terminal to AC

Table 7-5 Outlet sockets

Name Socket No. Description

D5V PIN1: GND


J1
PIN2, PIN3: 5V

P12V, P24V PIN1: GND


J2 PIN2: 12V
PIN3: 24V

A+12V, A-12V PIN1, PIN4: GND


J3 PIN2, PIN3, PIN5: -12V
PIN6: 12V
AC120V J4 AC

7-12
Hardware System

7.4.3 Power Board Replacing and Wiring for the Original

Power Assembly
The power board plays a very important part in the device, and any error with the board may
endanger the operation of the whole. Follow below steps to replace the power board when
needed:

 Tools: 107 cross-headed screwdriver, multimeter.

 Disassembly:

1. Shut down the analyzer and pull out the AC cables;


2. Take out the power assembly from the main unit case;
3. Open the power unit, remove the 4 fixing screws on the power board, and then take out
the board from the power unit.

WARNING
 Wear an antistatic wrist strap while removing a board;

 Always shut down the power and pull out the power cable before removing a
board.

 Installation:

Install the power board in the reversed order of the disassembly steps.

 Check:

1. Check whether all the screws on the board are properly fixed;
2. Connect the power cable, and turn on the AC switch. The analyzer starts its initialization,
and all the indicators on the board light on.

CAUTION
 Ensure the power assembly is tightly fixed to the main unit case with
screws.

 Before disassemble the power board, ensure the power board and its
peripherals have cooled off.

7-13
Hardware System

7.4.4 Overview of the New Power Assembly


The power component consists of the Power Supply PCBA (051-002911-00) and the 3206
Power Board PCBA for Burning (051-002708-00). The power assembly provides the analyzer
with 6 units of reliable power output, including D5V, A+12V, A-12V, P30V, P12V, and AC120V.
Among which, AC120V is provided by the 3206 Power Board PCBA for Burning.
Definition of interfaces
The power assembly connects external boards through wires. It provides four interfaces
which can be distinguished by connected color wires.
The wire positions on the power board are illustrated as below:

Figure 7-6 Power board

The relationship between the wire colors and the output voltage of their connected interfaces
are listed below:

Table 7-6 Wires connecting the power assembly

Wire Color Output Voltage of Interface


Orange 30V

Yellow 12V

Red 5V

7-14
Hardware System

Blue and brown A±12V

Red twisted AC120V

7.4.5 Power Board Replacing and Wiring for the New Power

Assembly
Power boards play a very important part in the device, and any error with a power board may
endanger the operation of the whole. Follow below steps to replace a power board when
needed:

 Tools: 107 cross-headed screwdriver, multimeter.

 Disassembly:

1. Shut down the analyzer and pull out the AC cables;


2. Take out the power assembly from the main unit case;
3. Open the power unit, remove the 4 fixing screws on the Power Supply PCBA and those
on the Power Board PCBA for Burning, and then take out the two power boards.

WARNING
 Wear an antistatic wrist strap while removing a board;

 Always shut down the power and pull out the power cable before removing a
board.

 Installation:

Install the two power boards in the reversed order of the disassembly steps.

 Check:

1. Check whether all the screws on the two power boards are properly fixed;
2. Connect power cables, and then turn on the AC switch. The analyzer starts its
initialization, and all the indicators on the two boards light on.

CAUTION
 Ensure the power assembly is tightly fixed to the main unit case with screws.

 Before disassemble a power board, ensure these power boards and their
peripherals have cooled off.

7-15
Hardware System

7.5 Touch Screen Control Board


7.5.1 Introduction
As the interface between the touch screen and the main control board, the touch screen
control board transfers the touch actions from the users to recognizable signals by main
control board. You may need to make some adjustment to the touch screen control board
during use.

7.5.2 Components
With the 4-wire touch screen controller chip TSC2004IRTJR as its core chip, the board
communicates with the main control board about touch point positions through an I2C
interface.

I2C Touch
Pinaster main
screen Touch screen
control board
drive board

Figure 7-7 Connection of touch screen

7.6 Indicator Board


7.6.1 Introduction
The indicator board informs about the working status of the analyzer by sending out sounds
and lights.

Figure 7-8 Indicator board

7-16
Hardware System

7.6.2 Components
The indicator board consists of a three color indicator (red, yellow and green) with its control
circuit as well as the buzzer drive circuit. You do not need to make adjustment to the indicator
board during use.

7.7 Motors, Photocouplers and Micro-switches


7.7.1 Introduction
Motors drive the aspiration module and syringe module etc.; photocouplers detect the motor
movements; and micro-switches are used to start analysis process. See below for the
illustrations of motors and photocouplers.

7-17
Hardware System

7.8 Liquid Detection Board


7.8.1 Introduction
The liquid detection board detects whether there is liquid (including diluent and lyse) in the
tubes by monitoring the index of refraction.

Figure 7-9 Liquid detection board

7.8.2 Components
The most important components of the board are the photocouplers. There is an LED
indicator on the back of the board, which will light off when the photocoupler is blocked
between its transmitting and receiving tubes, and light on when the photocoupler is blocked.
You can use a piece of paper to block the photocoupler and check whether the board is
working properly.

7.9 Hardware Troubleshooting


7.9.1 System Error
Hardware system errors mainly include board errors, cable errors and component errors. The
subsequent sections should have provided troubleshooting methods for most of such errors;
but when the power supply to the hardware system is abnormal (for example, the analyzer
cannot be powered on, or would start self-protect mechanism immediately after being
powered on), you need to start troubleshooting from the system level. Figure 7-10
demonstrates the troubleshooting procedure for power supply errors. Figure 7-11 displays a
filter locating at the lower part at the rear of the analyzer. The filter controls the power supply
and frequency filtering of the analyzer.

7-18
Hardware System

Power supply abnormal

Is the N Unplug the power


AC power connection cord and then
reliable? reconnect it

Is the Disconnect and


filter connection N then reconnect the
reliable? plug

Does the
fuse of the power N
Replace the fuse
assembly work
properly?

Y
Is
the voltage Replace the AC
at the output pin N power cord. If the
normal after the filter voltage is still
switch is abnormal, replace
closed? the filter

Replace the power


assembly

Figure 7-10 Troubleshooting for power supply errors

Figure 7-11 Filter

Figure 7-12 shows the troubleshooting flowchart for power-on protection.

7-19
Hardware System

Protect right after


switching on the
power

Can you power on


N Power assembly
after unplugging all the
error. Replace the
cables at the power output
power assembly
end?

After confirming that the power assembly works properly,


supply power to the main control board. If the power
assembly cannot start normally, there should be short-
circuit or open-circuit on the board. Repair the board
according to the corresponding instructions.

Figure 7-12 Troubleshooting for power-on protection errors

7.9.2 Troubleshooting for Main Control Board


Table 7-7 lists the errors commonly found on the main control board as well as their solutions.
However, the list only includes hardware errors and sometimes software errors may cause
similar problem. Also many errors need to be detected by software.
Check the following items before troubleshooting the main control board:
1. Check whether the cables connecting to the main control board get loose or insecure.
2. Check whether the position no. marked on the cable correspond to the sockets there are
connected to; and whether the cables are broken or damaged;
3. Check whether the input power of sockets J4~J6 on the board are normal (measure the
voltages with a multimeter; refer to "Definition of sockets" for the pin functions).
4. Check whether the indicators on the main control board work properly against Table 7-2.
When you have confirmed all the cables are properly connected, all the input power and
indicators work normally, follow the instruction in Table 7-7 for troubleshooting.

7-20
Hardware System

Table 7-7 Troubleshooting for main control board

No. Error Troubleshooting Solution


1 LCD 1. Check whether the cable connecting the main Unplug and
screen control board and the backlight socket, and the reconnect the cable
becomes cable connecting the main control board and the connecting the main
black. LCD screen are properly connected. Unplug and control board and
then reconnect such cables. Power on the the backlight and the
analyzer again and see whether the error is cable connecting the
removed. If not, proceed to next step. main control board
and the LCD screen.

2. Replace the cable connecting the main control Replace the cable
board and the backlight and the cable connecting the main
connecting the main control board and the LCD control board and
screen. If the error still exists, proceed to next the backlight and the
step. cable connecting the
main control board
and the LCD screen.

3. Use a multimeter to measure the voltage Replace the main


between PIN1 and PIN3 of J25, when the result control board
is not within the range of 10.5~13.5, then the
power supply to backlight is with error. If not the
case, proceed to next step.
4. Use a multimeter to measure the voltage
between TP8 and TP9, when the result is not
within the range of 0.7~1.1V, then there is
backlight brightness control error. If not the case,
proceed to next step.

5. Use a multimeter to measure the voltage


between TP7 and TP9, when the result is not
within the range of 3.10~3.50V, then there is
backlight enabling error. If not the case, proceed
to next step.

6. Replace the LCD screen. If the error remains, Replace the LCD
proceed to next step. screen

7-21
Hardware System

2 LCD 1. Reconnect the cable connecting the main Unplug and


display control board and the backlight socket, and the reconnect the cable
flickers cable connecting the main control board and the connecting the main
LCD screen. Power on the analyzer again and control board and
see whether the error is removed. If not, proceed the backlight and the
to next step. cable connecting the
main control board
and the LCD screen.
2. Replace the cable connecting the main control Replace the cable
board and the backlight and the cable connecting the main
connecting the main control board and the LCD control board and
screen. If the error still exists, proceed to next the backlight and the
step. cable connecting the
main control board
and the LCD screen.

3. Replace the main control board. If the error is Replace the main
removed, then the problem is caused by control board
differential conversion chip (U10) or board
AM1808 failure. If not, proceed to next step.

4. Replace the LCD screen (screen assembly). If Replace the screen


the error is removed, then the problem was assembly
caused by LCD assembly failure.

3 LCD 1. Reconnect the cable connecting the main Reconnect the cable
displays control board and the LCD screen. Power on the connecting the main
strange analyzer again and see whether the error is control board and
patterns removed. If not, proceed to next step. the LCD screen.

2. Replace the cable connecting the main control Replace the cable
board and the LCD screen. If the error still exists, connecting the main
proceed to next step. control board and
the LCD screen.

4. Replace the main control board. If the error Replace the main
remains, proceed to next step. control board

5. Replace the LCD screen (screen assembly). If Replace the screen


the error is removed, then the problem was assembly
caused by LCD assembly failure.

7-22
Hardware System

4 Bad 1. Check whether the IP of the PC falls in the Set the IP of the PC
network same network segment of the main control board to 10.0.0.3.
connection IP (10.0.0.X). When it is not, reset the IP of the
PC to 10.0.0.3, and see whether the network
connection is OK. If the network connection still
fails, proceed to next step.
2. When the analyzer is powered on and Reconnect or
connected to PC, but D1 and D2 do not light on, replace the network
then the network connection is bad or the cable.
network cable is damaged. If not the case,
proceed to next step.

3. D1 and D2 off, but network connection is OK. Replace the main


control board

5 USB ports 1. If D10 and D12 do not light on when the Replace the main
fail to analyzer is powered on, then the USB HUB chip control board
response. (U1) is with error. If not the case, proceed to next
step

2. If D10 and D12 do light on when the analyzer Replace the devices
is powered on, replace the peripherals connecting to the
connected to the USB ports (mouse, keyboard or USB ports.
USB disk etc.). If the peripherals still cannot be
used, proceed to next step.

3. If the error still remains after all above steps, Replace the main
replace the main control board. control board

6 Clock time 1. Power off the analyzer, and use a multimeter Replace the button
resets to measure the voltage between the two ends of cell.
every time the button cell B1. When the measured voltage is
after <1.8V, then the cell is with low power. If not the
startup case, proceed to next step.

2. If the error still exists after the button cell is Replace the main
replaced and the time is correctly reset, replace control board
the main control board.
7 Analyzer 1. Check whether the cable connecting to the
gives no [Aspirate] key gets loose or broken. If yes,

7-23
Hardware System

respond reconnect the cable or replace it.


when the 2. If the error remains after step 1, disassemble
[Aspirate] the connecting board to the [Aspirate] key
key is switch, and see whether there is liquid split on
pressed the switch. If yes, clean the liquid and re-install
the board.

7.9.3 Power Board Errors


Follow below procedure for power board troubleshooting.

Power board voltage


output error

Check the
Is the AC input components
N
voltage normal? including the filter,
fuse

Replace the power


board

Figure 7-13 Troubleshooting for power board errors

7.9.4 Touch Screen Control Board Errors

Table 7-8 Troubleshooting for touch screen errors

Error
No. Possible Cause Solution
Description

1 Touch screen Touch screen 1. Check whether the main control board works
does not control board properly (e.g. check whether the display screen
response error/touch screen displays normally, and whether the analyzer can
when being error/poor be operated with a mouse. If not, start
touched connection troubleshooting for the main control board first;
2. Check whether the connecting cable between
the touch screen drive board and the main control
board get loose or broken. If yes, reconnect or

7-24
Hardware System

replace the cable accordingly;


3. If the error remains after step 1 and 2, replace
the touch screen drive board;
4. If the error still remains, replace the touch
screen.

2 The cursor The cable 1. Check whether is any crack on the touch screen.
only moves in connecting the If yes, replace the touch screen.
horizontal or touch screen 2. Reconnect the cable connecting the touch
vertical control board and screen control board and the touch screen.
direction. the touch screen
gets broken

3 The cursor Touch screen is 1. Perform the touch screen calibration procedure
cannot arrive not to calibrate the touch screen again (if the cursor
at a certain calibrated/touch position deviates seriously from the intended
position screen gets touched position, so that you cannot even enter the
cracked touch screen calibration screen, use a USB mouse
to operate and enter the calibration screen);
2. When the error still remains, check if there is any
crack on the touch screen. If yes, replace the touch
screen.

4 The The foam in the 1. Remove the front cover, reinstall the
touchscreen front cover touchscreen, Ensure that the foam is in the out ring
has no presses the of the touchscreen and is not pressing the
response touchscreen. touchscreen.
when it is
clicked. The
cursor stays
in one corner
and cannot
move.

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Hardware System

7.9.5 Indicator Board Errors

Table 7-9 Troubleshooting for indicator errors

Error
No. Error type Troubleshooting
description
1 Indicator Indicator won't 1. Check whether the main control board works
light on properly (screen displays normally, and basic
operations like sample analysis and information
review can be run properly). When there is any
problem, start troubleshooting for the main control
board first;
2. Check whether the cables connecting to the
indicator board get loose or broken. If they get loose,
reconnect the cables; if they get broken, replace it as
well as the front panel signal cables;
3. If cable errors can be excluded, replace the
indicator board.

2 Buzzer Buzzer won't 1. Check whether the main control board works
sound when properly (screen displays normally, and basic
the analyzer operations like sample analysis and information
rings alarms review can be run properly). When there is any
problem, start troubleshooting for the main control
board first;
2. Check whether the cables connecting to the
indicator board get loose or broken. If they get loose,
reconnect the cables; if they get broken, replace it as
well as the front panel signal cables;
3. If cable errors can be excluded, replace the
indicator board.

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Hardware System

7.9.6 Motor and Photocoupler Errors

Table 7-10 Troubleshooting for motors, photocouplers and micro-switches

Error
No. Error type Troubleshooting
description
1 Motors The motor does 1. Check whether the problem is caused by main
not rotate. control board error (whether LCD may display
properly, if there is any power-related alarms); when
the main control board is with error, remove the
main control board error first;
2. Check whether the cable connecting a motor and
the main control board get loose or broken;
reconnect and replace the cable if necessary;
3. If cable errors can be excluded, replace the
motor.

Motor won't 1. Check whether the problem is caused by main


stop at control board error (whether LCD may display
designated properly, if there is any power-related alarms); when
position the main control board is with error, remove the

2 Photocoupler Motor rotates, main control board error first;

but won't arrive 2. Check whether the cable connecting a

at the photocoupler and the main control board get loose

designated or broken; reconnect and replace the cable if

position. necessary;
3. If cable errors can be excluded, replace the
photocoupler.

7.9.7 Liquid detection board error


When there is reagent, the TP4 on the board should output low-level voltage (less than 0.8V)
and the LED is off; when there is no reagent, TP4 should output high-level voltage (higher
than 2V), and the LED lights on. When there is an error, check whether the LED status and
the voltage measured on the test point are in accordance with reagent status.

7-27
8 Mechanical System

8.1 Introduction to Mechanical Structure


This section demonstrates the positions of major serviceable components in the analyzer so
our service people may find these components quickly to remove or replace them.
Figures, pictures and drawings in this manual are prepared based on BC-30s/BC-31s, of
which the structure is basically the same as that of other models.

8.1.1 Front of the Analyzer

Figure 8-1 Front of the analyzer

1 ---- Display screen 2 ---- Power/status indicator


3 ---- Key supporting board (probe wipe 4 ---- Sample probe
block)
5 --- [Aspirate] key

8-1
Mechanical System

Figure 8-2 Front of the analyzer (front cover open)

1 --- [Aspirate] key 2 --- [Start] key


3 --- Syringe

8-2
Mechanical System

8.1.2 Back of the Analyzer

Figure 8-3 Back of the analyzer

1 --- USB port 2 --- Network interface


3 --- Power input socket 4 --- Waste sensor connector
5 --- Waste outlet 6 --- Diluent connector

8-3
Mechanical System

8.1.3 Left Side of the Analyzer

Figure 8-4 Left side of the analyzer

1 --- Recorder 2 --- Side door

Figure 8-5 Left side of the analyzer (left door open)

1 --- Main control board 2 --- Reagent bottle

8-4
Mechanical System

8.1.4 Right Side of the Analyzer

Figure 8-6 Right side of the analyzer (right door open)

1 --- WBC/RBC baths 2 --- Diluent heating assembly


3 --- Waste pump assembly 4 --- Vacuum chamber assembly
5 --- Diluent temperature sensor 6 --- Liquid level detection unit
7 --- Air pump 8 --- Solenoid valve
9 --- Aspiration module 10 --- Front cover assembly

8.2 Overview of Assemblies


8.2.1 Introduction
This section not only displays the explosive views of various assemblies of the analyzer, but
also lists the BOM for each assembly, so our service people may find the component quickly
to remove or replace them.

8-5
Mechanical System

NOTE
 The material IDs listed in the BOM shall only be used by service people to find
the material numbers of maintenance spare parts. Provide the material ID when
purchasing any maintenance spare part.

8.2.2 Whole Device


8.2.2.1 Explosive View

8.2.2.2 Bill of Materials


Maintenance spare
ID Material description Remarks
part ID
1 Main unit / /
2 Front cover assembly / /
3 Right door / /
4 Top cover / /
Cross-recessed small panhead
5 screw combination GB/T9074.8 / /
M3X8
Cross-recessed sunk screw
6 / /
GB/T819.1-2000 M3X6

8-6
Mechanical System

8.2.3 Main Unit


8.2.3.1 Explosive View

8.2.3.2 Bill of Materials


Maintenance
ID Material description Remarks
spare part ID
1 Frame assembly / /
2 Start key assembly 115-025647-00
3 Start key / /
4 Key installation board / /
5 Syringe assembly 115-025639-00 /

8-7
Mechanical System

Maintenance
ID Material description Remarks
spare part ID
6 Insulation bar / /
7 Sampling assembly 115-025638-00 /
8 Shielding bottom plate welding piece / /
9 3-way Valve (Mindray) 801-3201-00003-00 /
10 WBC bath assembly 115-025645-00 /
11 RBC bath assembly 115-025644-00 /
12 Isolation chamber filter (injection molding) 043-000711-00 /
13 Isolation chamber 801-1805-00023-00 /
14 Isolation chamber holder / /
15 Shielding box / /
16 Right door / /
17 Reagent pre-heater assembly 115-049623-00 /
18 Waste pump assembly 115-025643-00 /
19 Vacuum chamber assembly 115-025641-00 /
20 Diluent temperature detection unit 115-015677-00 /
21 Air pump assembly 115-025715-00 /
22 2-way Valve (Mindray) 801-3201-00002-00 /
23 SMC 3-way valve(3106) 115-015967-00 /
24 Reagent detection assembly 115-025642-00 /

8-8
Mechanical System

8-9
Mechanical System

Maintenance spare
ID Material description Remarks
part ID
25 Power pack assembly 115-054722-00 /
26 Lower signal shielding cover / /
051-001714-00 /
27 3008 main control board PCBA 051-001714-02 / /
051-001714-03
28 Upper signal shielding cover / /
29 Left door assembly / /
30 TR60-H recorder 801-2800-00016-00 /
31 Reagent container / /
32 Lyse container cap assembly / /
33 Top cover / /

8.2.4 Front Cover Assembly (8.4 in)


The front cover assemblies of the BC-20s, 21s, BC-10, BC-10e, and BC-11 all use the 8.4
inch screen. This section demonstrates the structure of the front cover assembly of the
BC-20s. The structure of the front cover assembly of other models, including BC-21s, BC-10,
BC-10e, and BC-11, is basically the same as that of BC-20s, expect the front cover material.

8.2.4.1 Explosive View

8-10
Mechanical System

8.2.4.2 Bill of Materials


Maintenance
ID Material description Remarks
spare part ID
1 Nel assembled (BC-20S) 043-007675-00 These 3
Long weather strip for 8 in touch screen must be
2 047-005535-00
LONG GASKET, IPM8 TOUCH SREEN replaced
at the
3 SHORT GASKET, IPM8 TOUCH SREEN 047-005536-00 same
time
4 Touchpanel resistive 8.4inch 4-wires 021-000271-00 /
5 LCD assembly(8.4") 115-039856-00 /
Cross-recessed small panhead screw combination
6 GB/T9074.8 M3X8 with environment-friendly / /
color-zinc coating
Cross-recessed panhead self-drilling screw with no
7 cone point PT3X8, with environment-friendly / /
color-zinc coating
8 3008 keypad PCBA / /

8-11
Mechanical System

8.2.5 Front Cover Assembly (10.4 inch)


The front cover assemblies of the BC-30s, BC-31s, BC-20, BC-21, BC-30, BC-31, and
BC-30e all use the 10.4-inch screen. This section demonstrates the structure of the front
cover assembly of the BC-30s. The structure of the front cover assembly of other models,
including BC-31s, BC-20, BC-21, BC-30, BC-31, and BC-30e, is basically the same as that of
BC-30s, expect the front cover material.

8.2.5.1 Explosive view

8.2.5.2 Bill of materials


Maintenance
ID Material description Remarks
spare part ID
1 Panel assembled (BC-30S) 043-005464-00 These 3
2 10INCH TOUCHSCREEN LONG GASKET 047-016362-00 must be
replaced
at the
3 10INCH TOUCHSCREEN SHORT GASKET 047-016363-00
same
time
4 Touch screen 10.4' 801-3110-00184-00 /
5 LCD assembly (10.4") 115-025652-00 /
6 Cross-recessed small panhead screw combination / /

8-12
Mechanical System

Maintenance
ID Material description Remarks
spare part ID
GB/T9074.8 M3X8 with environment-friendly
color-zinc coating
Cross-recessed panhead self-drilling screw with no
7 cone point PT3X8, with environment-friendly / /
color-zinc coating
8 3008 keypad PCBA / /

8.2.6 Syringe Assembly


8.2.6.1 Explosive View

8.2.6.2 Bill of Materials


Maintenance spare part
ID Material description Remarks
ID
1 Stepping motor SST42D2120 / /
2 Mindray syringe coupling / /
3 Rubber washer + positioning bush / /
4 Special bolt 3 041-005167-00 /
5 Mindray Syringe assembly.10Ml 801-3003-00027-00 /
Cross-recessed small panhead screw
6 / /
combination M3X8
7 Syringe fixing plate (1 to 2) / /
8 250ul syringe (with nozzle) 115-027479-00 /

8-13
Mechanical System

Maintenance spare part


ID Material description Remarks
ID
9 Rotation Motor Position Sensor Assembly 801-3003-00015-00 /
10 Cross-recessed panhead screw M3X6 / /
11 Inner hexagon socket cap screw M3X12 / /

8.2.7 Sample Probe Assembly


8.2.7.1 Explosive View

8.2.7.2 Bill of Materials


ID Material description Maintenance spare part ID Remarks
1 Probe fixing plate / /
Cross-recessed small panhead screw
2 / /
combination M3X8
3 Sample probe 801-1805-00003-00 /
4 Sample Probe Wipe Block 801-1805-00004-00 /
Rotation Motor Position Sensor
5 801-3003-00015-00 /
Assembly
6 Cross-recessed panhead screw M3X4 / /
7 Sensor package 801-3001-00055-00 /
8 Rubber washer + positioning bush / /

8-14
Mechanical System

8.2.8 WBC Bath Assembly


8.2.8.1 Explosive View

8.2.8.2 Bill of Materials


Maintenance spare part
ID Material description Remarks
ID
1 RBC bath / /
2 HGB module 115-025640-00 /
3 Back room electrode / /
4 Front bath washer / /
5 White Blood Cell Ruby Aperture / /
6 RBC back pool / /
7 Chamber adjusting plate / /
9 Pull mounting plate / /
Stainless cross recessed pan head screws
8 GB/T818-2000 M3X6 / /

10 Pool cover of RBC 043-009250-00 /


11 O-ring 21.2X1.8 silicone A50 / /
12 Electrode Of Platinum Filament / /

8-15
Mechanical System

8.2.9 RBC Bath Assembly


8.2.9.1 Explosive View

8.2.9.2 Bill of Materials


ID Material description Maintenance spare part ID Remarks
1 RBC bath / /
2 Electrode of platinum filament / /

3 / /
O-ring 21.2X1.8 silicone A50
4 Pool cover of RBC 043-009250-00 /
Stainless cross recessed pan head
5 / /
screws GB/T818-2000 M3X6
6 pull mounting plate / /
7 chamber adjusting plate / /
8 RBC back pool / /
9 Front bath washer / /
10 Ruby Red Cell Counter
11 Back room electrode

8-16
Mechanical System

8.2.10 Pump Assembly


8.2.10.1 Explosive View

8.2.10.2 Bill of Materials


Maintenance
ID Material description Remarks
spare part ID
1 Rotation waste pump /
/
6 Pump connecting cable (white connector) /
2 Pump fixing plate / /
3 Rubber ring / /
4 Rubber ring positioning bush / /
Cross-recessed small panhead screw
5 combination GB/T9074.8 M3X8 with / /
environment-friendly color-zinc coating

8-17
Mechanical System

8.2.11 Power Unit


8.2.11.1 Explosive View

8.2.11.2 Bill of Materials


ID Material description Maintenance spare part ID Remarks
1 Power unit bottom plate / /
2 3206 Power Board PCBA for Burning 051-002708-00 /
3 3008 Power Supply PCBA 051-002911-00 /
4 Power unit cover plate / /
5 Power unit back plate /
Power unit back plate
6 Cross-recessed panhead screw / /
GB/T9074.8 M3X8
FAN 12Vdc 40*40*10MM 4.1cfm 25dB
7 024-001032-00 /
300mm
8 M3 hex nut with washer /
Filter power 115/250VAC6A panel
9 /
mount
Cross recessed countersunk head
10 /
screws GB/T819.1-2000 M3X6

8-18
Mechanical System

8.2.12 Reagent Detection Assembly


8.2.12.1 Explosive View

8.2.12.2 Bill of Materials


ID Material description Maintenance spare part ID Remarks
Reagent detection assembly
1 / /
installation plate
2 Liquid detect board PCBA 051-001621-00 /
3 Reagent detection tube 043-000829-00 /

8.3 Disassembly and Installation


8.3.1 Tools
You may need following tools to disassemble and replace mechanical components:

 Cross-headed screwdriver (107)

 Flat-headed screwdriver

 Tweezers

 Nipper pliers

 cutting nippers

 Hexagon spanner (1 suite)

8-19
Mechanical System

8.3.2 Before Disassembly


Before disassemble the analyzer, make sure you have completed the following steps:

 Stop using the analyzer and make sure the sample probe has returned to the aspiration
position. Shut down the analyzer, and disconnect all accessories and external
equipment.

 Power off the analyzer.

 All the analyzer components and surfaces are potentially infectious, so take
proper protective measures for operation and maintenance.

WARNING
 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 and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

 Eliminate static electricity before disassembly. While removing the


components with electrostatic sensitive mark, please wear protective
equipment such like an anti-static wrist strap or anti-static gloves to avoid
ESD damage to the components.

 Short circuit may be caused when wires are pressed or damaged. Connect
and place the wires properly while placing the components.

 Use correct screws during re-installation. Using wrong screws may cause
equipment damage. Such screws and the parts fixed by them may become
loose and fall off, resulting in unexpected product damage or personal injury.

 Disassemble the instrument in the specified order. Failing to do so may cause


irreversible damage to the instrument.

 Make sure all cables have been disconnected before disassembling the
components. Be careful not to break the cables or the connectors during

8-20
Mechanical System

disassembly.

 Store the removed screws and other parts in separate places so you can find
them easily during re-installation. Be careful not to drop, contaminate or lose
them.

 Separately store the disassembled materials by modules so you can find them
quickly and correctly during re-installation.

 During re-installation, assemble the components first then the main unit. Be
careful with the wire connections. Place the wires in proper position.

8.4 Removing the Main Unit

CAUTION
 To avoid the display screen gets scratched, make sure the analyzer is
disassembled at a position which is smooth and with no foreign object on it.

 All operations should be performed by Mindray authorized personnel. Always


wear insulating gloves when servicing a board.

 Carefully check all the fluidic tubes after assembly and make sure there is no
bending or folding.

8.4.1 Remove Left Door Assembly


Place the analyzer on a flat desktop. Remove the 3 M3×8 screws, and push the left door
assembly a little towards the rear of the analyzer. Pull the assembly out to the left side of the
analyzer for about 40cm. Then unplug the connector of recorder cable, and remove the left
door assembly (see below).

8-21
Mechanical System

8.4.2 Remove Main Control Board


1. Follow the instruction in section 8.4.1 to remove the left door assembly;
2. Remove the SD card;
3. Remove the 4 M3×8 screws to disassemble the upper signal shielding cover (as shown
below);

4. Unplug all the cables connecting to the main control board, and remove the 9 M3×8
screws. Then take out the main control board (as shown below).

8-22
Mechanical System

5. Remove the 2 M3×8 screws to disassemble the lower signal shielding cover (as shown
below);

 Installation:

Install the power board in the reversed order of the disassembly steps.

 Verification:

1. Make sure all the cables connecting to the main control board are properly and correctly
connected;
2. Power on the analyzer and electrify the main control board. Check whether the main
control board analog power and its status indicator work normally;
3. Run a background test. If there is no alarm sounded, then main control board is
successfully replaced. Otherwise perform the troubleshooting procedure.

8-23
Mechanical System

 Note:

When a main control board is replaced, restore the data on the SD card to the new main
control board; when an SD card is replaced, backup the data on the main control board to the
new SD card.

8.4.3 Remove the right door


Place the analyzer on a flat desktop (as shown below). Remove the 3 M3×8 screws fixing the
right door (at the rear of the analyzer) to remove the right door.

8.4.4 Remove the RBC Bath Assembly


1. Follow step 1 and 2 in section 8.4.2 to remove the upper signal shielding cover and
unplug the connector of the signal cable;
2. Follow the instruction in section 8.4.3 to remove the right door;
3. Remove the 4 M3×8 screws to disassemble the shielding box (as shown below);

4. As shown below, remove all the tubes below the bath, and take out the 2 M3 screws
fixing the bath assembly as well as the M3X8 screws. Remove the bath assembly.

8-24
Mechanical System

 Installation:

Install the aperture sensor in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected;
3. For the debugging and verification information of a certain component, refer to Chapter
11.

CAUTION
 Before removing the shielding box of a bath, adjust the position of the sample
probe and make sure it is not in the shielding box. Otherwise the sample probe
may get bent or injure the operator.

8.4.5 Remove WBC bath and HGB Light Assembly


1. Follow step 1 and 2 in section 8.4.4 to remove the shielding box,
2. Follow the instructions in section 8.4.1 to remove the left door assembly and unplug the
connector of HGB unit from the main board.
3. As shown below, remove the 2 M3 screws fixing the bath cover and take out the lower
part of the WBC bath assembly. Rotate the HGB light assembly 90°counterclockwise to
remove it.

8-25
Mechanical System

 Installation:

Install the aperture sensor in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. For the debugging and verification information of a certain component, refer to Chapter
11.

CAUTION
 Before removing the shielding box of a bath, adjust the position of the sample
probe and make sure it is not in the shielding box. Otherwise the sample probe
may get bent or injure the operator.

8.4.6 Remove Preheating Assembly


1. Follow the instruction in section 8.4.3 to remove the right door;
2. As shown below, unplug all the tubes of the preheating assembly and remove the 2
M3×8 screws. Then take out the heater and pull its connector out of the hole. Unplug the
connector of the cable to the preheating assembly (keep the connector at the left side of
the analyzer for re-installation).

8-26
Mechanical System

 Installation:

Install the preheating assembly in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the electrical components are correctly connected.

3. Power on the analyzer and tap the “ ” button to enter the system menu. Select
"Status" →"Temp. & Pressure", and check whether the "Reagent Preheating
Temperature" column displays in red. If it is, then the error still exists.

8.4.7 Remove Right Side Valve Assembly


1. Follow the instruction in section 8.4.3 to remove the right door;
2. As shown below, unplug all the tubes of the valve to be serviced, and remove the 2
M3×12 screws. Then take out the valve assembly and pull its connector out of the hole.
Unplug the connector of the cable to the valve (keep the connector at the left side of the
analyzer for re-installation).

8-27
Mechanical System

 Installation:

Install the preheating assembly in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected;

3. Power on the analyzer and tap the " " button to enter the system menu. Tap "Service"
→“Self-Test" → "Valve Self-Test" to enter the valve self-test screen. Tap the valve to be
serviced (see the silk-screen on the fluidic spacer for the valve number), and see if it can
be turned on and off normally.

8.4.8 Remove Liquid Detection Board PCBA


1. Follow the instruction in section 8.4.3 to remove the right door;
2. Remove the 2 M3×8 screws and take out the liquid detection board installation box and
PCBA.

3. Remove the tubes and cables connected to the liquid detection board and take out the
liquid detection board PCBA.

8-28
Mechanical System

 Note:

During installation, the PCBA connector at the position should connect reagent tube, the
other connector should connect diluent tube.

Marked “L”

8.4.9 Remove Waste Pump


1. Follow the instruction in section 8.4.3 to remove the right door;
2. As shown below, unplug all the tubes of the pump to be serviced, and remove the 4
M3×12 screws as well as the washers. Then take out the pump and pull its connector out
of the hole. Unplug the connector of the cable to the waste pump (keep the connector at
the left side of the analyzer for re-installation).

 Installation:

Install the preheating assembly in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8-29
Mechanical System

8.4.10 Remove the Air Pump


1. Follow the instruction in section 8.4.3 to remove the right door;
2. As shown below, unplug the tubes connected to the pump, cut off the cable ties. Then
remove the air pump and unplug the cable connectors.

 Installation:

Install the air pump in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.11 Remove Vacuum Chamber Assembly


1. Follow the instruction in section 8.4.3 to remove the right door;
2. Unplug the tubes connected to the vacuum chamber and remove the 2 M3×8 screws to
take out the vacuum chamber assembly.

8-30
Mechanical System

 Installation:

Install the vacuum chamber in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.

3. Power on the analyzer and tap the “ ” button to enter the system menu. Select

"Status" →"Temp.& Pressure", and check whether the "Vacuum" column displays in red.
If it is, then the error still exists.
4. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.12 Remove the Diluent Temperature Sensor


1. Follow the instruction in section 8.4.3 to remove the right door;
2. Unplug all the cable connectors and tubes connected the temperature sensor.

 Installation:

Install the vacuum chamber in the reversed order of the disassembly steps.

 Verification:

1. Make sure all the tubes and electrical components are correctly connected;

2. Power on the analyzer and tap the “ ” button to enter the system menu. Select
"Status" →"Temp.& Pressure", and check whether the "Diluent Temperature" column
displays in red. If it is, then the error still exists.

8-31
Mechanical System

8.4.13 Remove the Top Cover


As shown below, remove the 2 M3×8 screws and lift up the top cover from the rear edges of
the analyzer to remove the cover.

8.4.14 Remove the Aspiration Module


1. Follow the instruction in section 8.4.3 to remove the right door;
2. Follow the instructions in 8.4.13 to remove the top cover. Unplug the cable connectors
connecting the motors and the upper and lower sensors from the aspiration module.
3. As shown below, remove the tubes and the 4 M3×12 screws as well as the washers.
Then lift up the aspiration module to remove it.

8-32
Mechanical System

 Installation:

Install the aspiration module in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes and electrical components are correctly connected.

3. Power on the analyzer and tap the " " button to enter the system menu. Select
"Service" → "Sample Probe Debug" to debug and confirm the up, middle and down
positions of the sample probe initial position and of WBC and RBC baths, so as to
ensure the reliable operation of sample probe.
4. For the debugging and verification information of a certain component, refer to Chapter
11.

8-33
Mechanical System

8.4.15 Remove the Motor Horizontal Photocoupler Assembly

of Aspiration Module
1. Follow the instruction in section 8.4.14 to remove the aspiration module;
2. Remove the 4 M3×4 screws to disassemble the photocoupler assembly (as shown
below);

 Installation:

Install the photocoupler assembly in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;

2. Power on the analyzer and tap the " " button to enter the system menu, select
""Service" → "Sample Probe Debug" → "Initial position" to return the sample probe to
the initial position, and then tap "RBC Bath" and "Aspiration Position" to confirm that
sample probe can move there properly.
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.16 Replace Sample Probe


1. Power on the analyzer and tap the " " button to enter the system menu. Select
"Service" → "Sample Probe Debug", and then tap "Initial position" to make the sample
probe move to above the WBC bath;
2. Follow the instruction in section 8.4.4 to remove the bath shielding box;
3. As shown below, unplug the tube connected to the sample probe, and remove the M3
screw and the fixing plate. Then remove the sample probe.

8-34
Mechanical System

 Installation:

Install the sample probe in the reversed order of the disassembly steps.
For the debug method of sample probe position, refer to section 0.

 Verification:

1. make sure all the tubes are correctly connected;


2. Power on the analyzer and tap the " " button to enter the system menu. Select
"Service" → "Sample Probe Debug" to debug the up, middle and down positions of the
sample probe initial position and of WBC and RBC baths, so as to ensure the reliable
operation of sample probe.
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.17 Remove the Probe Wipe


1. Power on the analyzer and tap the " " button to enter the system menu. Select
"Service" → "Sample Probe Debug", and then tap "Initial position" to make the sample
probe move to above the WBC bath;
2. Follow the steps of section 8.4.18 to remove the fixing plate and the sample probe.
3. Remove the probe wipe from the right side (as shown below) and unplug the tube
connected to the probe wipe.

8-35
Mechanical System

 Installation:

Install the probe wipe in the reversed order of the disassembly steps. Follow the instruction of
8.4.17 to adjust the sample probe positions.

 Verification:

1. make sure all the tubes are correctly connected;

2. Power on the analyzer and tap the " " button to enter the system menu. Select
"Service" → "Sample Probe Debug" to debug the up, middle and down positions of the
sample probe initial position and of WBC and RBC baths, so as to ensure the reliable
operation of sample probe.
3. Restart the analyzer to perform the "sample probe cleaning" procedure, and check
whether there is liquid flowing from the bottom of the sample wipe.
4. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.18 Remove the Aspiration Module Photocoupler in

Vertical Direction
1. Follow the instructions in 8.4.13 to remove the top cover. Unplug the cable connectors of
the photocoupler assembly of aspiration module motor.
2. Follow the instruction in section 8.4.3 to remove the right door;

3. tap the " " button to enter the system menu. Select "Service" → "Sample Probe
Debug"→ "Initial Position"→ "RBC Bath" , Move the sample probe to the position above
the RBC bath, and use a diagonal pliers to cut the cable tie that fixing the photocoupler
assembly cables. Remove the cable connector.

8-36
Mechanical System

4. Tap the "Aspiration pos" button , move the sample probe to the front aspiration position
(as shown below) and remove the M3×4 screw. Pull down and remove the photocoupler
assembly from the front side.

Installation:
Install the photocoupler assembly in the reversed order of the disassembly steps.
Verification:
1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the electrical components are correctly connected.

3. Power on the analyzer and tap the " " button to enter the system menu, select

""Service" → "Sample Probe Debug" → "Initial position" to return the sample probe to
the initial position, and then tap "Up", "Middle Position" and "Down Position" to confirm
that sample probe can move there properly.
4. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.19 Remove the Front Cover Assembly


1. Place the analyzer on a flat desktop.
2. Follow the instruction in section 8.4.1 to remove the left door assembly and remove the
cables of front cover assembly from the main control board;

8-37
Mechanical System

J25
J24

J26

J24 Socket for LCD signal processing

J25 Socket for LCD backlight control


J26 Socket to touch screen pinboard

3. Follow the instruction in section 8.4.3 to remove the right door;


4. Follow the instruction in section 8.4.13 to remove the top cover;
5. Remove the 6 M3×6 sunk screws locating at left, right and top sides. Then remove the
front cover assembly from the main unit and place it on a flat desktop.

8-38
Mechanical System

8.4.20 Remove Indicator PCBA


1. Follow the instructions in 8.4.21 to remove the front cover assembly and place it on a flat
desktop. Unplug the cable connector to the indicator terminal.
2. Remove the 2 M3×10 screws (as shown below), and then remove the indicator board
shield and the indicator board PCBA.

 Installation:

Install the indicator PCBA in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Power on the analyzer and make sure the status indicator light on.

8-39
Mechanical System

8.4.21 Remove the Touch Screen Control Board


1. Follow the instructions in 8.4.21 to remove the front cover assembly and place it on a flat
desktop. Unplug the cable connector to the touch screen control board.
2. Remove the 2 M3×8 screws to disassemble the shielding box of the touch screen control
board (as shown below);

3. Unplug the cable connecting to the touch screen, and remove the 2 M3×8 screws. Then
take out the touch screen control board (as shown below).

 Installation:

Install the touch screen control board in the reversed order of the disassembly steps.

8-40
Mechanical System

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Start the analyzer and check whether the touch screen works properly.

8.4.22 Remove the Touch Screen Assembly


1. Follow step 1 and 2 in 8.4.23 to remove the shielding box of the touch screen control
board, and unplug cables connecting to the touch screen.
2. As shown below, remove the 4 M3×8 screws fixing the screen assembly, take out the
screen assembly and unplug all the cables connected to the screen.

 Installation:

Install the touch screen assembly in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Start the analyzer and check whether the display screen works properly.

8.4.23 Remove the Touch Screen


1. Follow step 1 and 2 in 8.4.23 to remove the shielding box of the touch screen control
board, and unplug cables connecting to the touch screen.
2. As shown below, remove the 4 M3×8 screws fixing the screen assembly, take out the
screen assembly (no need to unplug the cables).

8-41
Mechanical System

3. Remove the touch screen from the front cover.

 Installation:

Install the touch screen in the reversed order of the disassembly steps.

 Verification:

1. Check whether the cables connecting the touch screen and the control board are tightly
locked;
2. Check whether all the parts and components are properly installed and fixed;
3. Calibrate the touch screen;
4. Start the analyzer and check whether the touch screen works properly.

8.4.24 Remove the Micro-switch Assembly


1. Follow the instructions in 8.4.21 to remove the front cover assembly and place it on a flat
desktop.
2. Remove the 2 M3×4 screws to disassemble the start key and its supporting board (as
shown below);

8-42
Mechanical System

3. As shown below, remove the 2 M3×8 screws, and take out the micro-switch assembly
from the little hole on the front plate. Pull its connector out of the hole. Unplug the
connector of the cable to the micro-switch assembly (keep the connector at the left side
of the analyzer for re-installation).

 Installation:

Install the micro-switch assembly in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. The start key can be pressed down and then bounds up. And you can hear a clear click
sound.
4. The analyzer runs analysis properly after startup.

8-43
Mechanical System

8.4.25 Remove the Syringe


1. Follow the instructions in 8.4.21 to remove the front cover assembly and place it on a flat
desktop.
2. Unplug the tube connecting to the syringe assembly.
3. As shown below, remove the 4 M3×12 screws as well as the washers, remove the
syringe assembly and unplug the cable connected to the syringe.

4. Remove the 3 M3×8 screws and the tailored screw to disassemble the syringe (as
shown below).

 Installation:

Install the syringe in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8-44
Mechanical System

8.4.26 Remove the Syringe Motor


1. Follow step 1 to 3 in 8.4.27 to remove the syringe assembly;
2. As shown below, remove the 2 M3×12 inner hexagon screws fixing the shaft connector,
and then remove the 4 M3×12 inner hexagon screws fixing the motor. Remove the
motor.

 Installation:

Install the motor in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.27 Remove the Syringe Motor Position Photocoupler

Assembly
1. Follow step 1 to 3 in 8.4.27 to remove the syringe assembly;
2. As shown below, remove the 2 M3×6 inner hexagon screws fixing the shaft connector,
and then remove the motor position photocoupler assembly.

8-45
Mechanical System

 Installation:

Install the motor position photocoupler assembly in the reversed order of the disassembly
steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. For the debugging and verification information of a certain component, refer to Chapter
11.

8.4.28 Replace RBC/WBC Isolation Chamber Filter


1. Follow the step 1 and step 3 of 8.4.4 to remove the right door and the RBC shielding
box;
2. As shown below, remove the M3×8 screw and the isolation chamber holder. Then
unplug the tube connected to the isolation chamber filter to remove it.

8-46
Mechanical System

 Installation:

Install the isolation chamber filter in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Make sure all the tubes are correctly connected.

8.4.29 Replace Power Unit


1. Follow the instruction in section 8.4.13 to remove the top cover;
2. Remove all the cable connectors on the top of the power unit;
3. As shown below, remove the 5 M4×8 screws and pull out the power unit for a certain
length. Remove the ground screw on the left side.

 Installation:

Install the power unit in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;

8-47
Mechanical System

8.4.30 Remove the Recorder


1. Open the recorder cover and remove the 2 M3X6 screws;
2. Push the fastener to the inner side and remove the recorder assembly;

3. Unplug the cable connected to the recorder.

 Installation:

Install the recorder in the reversed order of the disassembly steps.

 Verification:

1. Check whether all the parts and components are properly installed and fixed;
2. Ensure the cables are correctly connected;
3. Try the print function and make sure the printer work normally.

8-48
Mechanical System

8.5 HGB Assembly Replacement


Table 8-1 Difference between old and new circuit boards

Circuit board figure/PN Compatible HGB assembly Dial method Applicable


version
Old Old HGB assembly Applicable
circuit (applicable to version to version
board before EJ295F) before
115-025640-00 HGB module EJ295F
115-050158-00 Single Pass
Bath Assembly (no Cell Ruby
PN:051-001714-00
115-025645-00 WBC Bath
Assembly
115-049501-00 Single Pass
Bath Assembly

New New HGB assembly with Applicable


circuit “new 新 ” label (applicable to EJ295F
board to EJ295F and later version) and later
version

New label
location
PN : 051-001714-02 /
051-001714-03

115-025640-01 HGB module


(New LED)

Dial switch + label 115-050158-01 Single Pass


Bath Assembly (no Cell Ruby
(New LED)
115-025645-01 WBC Bath
Assembly (New LED)
115-049501-01 Single Pass
Bath Assembly (New LED)

8-49
Mechanical System

Old HGB assembly


(applicable to version
before EJ295F)
115-025640-00 HGB module
115-050158-00 Single Pass
Bath Assembly (no Cell Ruby
115-025645-00 WBC Bath
Assembly
115-049501-00 Single Pass
Bath Assembly

8.5.1 Maintenance Protocol


8.5.1.1 Error Phenomenon
After replacing the HGB assembly, the HGB blank voltage can’t reach the required range.

8.5.1.2 Solution
Maintenance scenario 1: new circuit board + new HGB assembly
1. Replace a new HGB circuit board.
2. Adjust the dial switch on the circuit board according to the following method.

3. Verify whether the adjustment has achieved satisfactory results referring to “Verification
after Replacement and Adjustment (Applicable to Maintenance Scenario 1&2)”.

Maintenance scenario 2: new circuit board + old HGB assembly


1. Replace a new HGB circuit board.
2. Adjust the dial switch on the circuit board according to the following method.

3. Verify whether the adjustment has achieved satisfactory results referring to “Verification
after Replacement and Adjustment (Applicable to Maintenance Scenario 1&2”.

Maintenance scenario 3: old circuit board + old HGB assembly


The HGB circuit can’t be adjusted by adjusting dial switch when the old HGB circuit
board is used. Adjust it on the “Gain Setup” screen if necessary.
If you cannot adjust the HGB circuit to the normal level on the “Gain Setup” screen, replace a
new circuit board, then adjust the circuit according to the “Maintenance scenario 2”.

8-50
Mechanical System

8.5.1.3 Verification after Replacement and Adjustment (Applicable to


Maintenance Scenario 1&2)
Login to the analyzer software using the service account, go to “Gain Setup” screen, check
whether the HGB blank voltage reaches the required range. If not, adjust the HGB gain
according to the following flowchart.

Adjust the HGB gain using


service account

YES Whether the HGB blank


voltage reaches the
required range

NO

Adjust the HGB blank voltage


according to the dial method in
the above table

Finish

8-51
9 Troubleshooting

Error Error Trigger Related Repair Troubleshooting


Name Code Mechanism Parts and Tools Guidance

AD reference
Main 0x010001 voltage out of 051-001714-00 /
control 01 range [2.4, 051-001714-02 / Replace the main
board 2.6]V 051-001714-03 control board
error 0x010001 EEPROM data Master Board PCBA
02 incorrect

1. Check whether the


button cell of the main
control board is
installed;
2. Replace with a new
The time M05-010R03---
button cell, and set up
indicated by Lithium battery
the date and time in the
System 0x010002 the system 051-001714-00 /
setup screen. Save the
clock error 01 clock is earlier 051-001714-02 /
settings, shut down the
than 051-001714-03
analyzer and then
2000-01-01 Master Board PCBA
restart;
3. If the error still exists
after restarting the
analyzer, replace the
main control board.

Constant 051-001714-00 /
0x010003 current source 051-001714-02 / Replace the main
01 voltage out of 051-001714-03 control board
range [47, 63]V Master Board PCBA
Power
+12V analog 115-025646-00 Check whether the
error 0x010003
voltage out of Power box assembly output of the power
02
range [11, 14]V 009-004354-00 DC board is normal using a
0x010003 -12V analog power cord multimeter. If the output
03 voltage out of Multimeter is abnormal, replace

9-1
Troubleshooting

range [-14, with a new power


-9]V board;

+12V power Unplug and reconnect


0x010003
voltage out of the power cord, or
04
range [11, 14]V replace with a new one;

24V power If the error still exists,


0x010003
voltage out of replace the main
05
range [20, 30]V control board.

115-025649-00
Diluent Pre_heating
assembly
Preheat
Preheat bath 051-001714-00 /
bath
0x010004 temperature 051-001714-02 /
temperatu
01 out of range 051-001714-03
re sensor
(0,70) ℃ Master Board PCBA Go to the status screen
error
009-004367-00 and check whether the
TempSensor Wire error exists;
Multimeter 2. Check the
115-015677-00 temperature sensor,
Diluent temperature connecting cable, and
detection unit main control board in
Diluent Diluent 051-001714-00 / turn.
temperatu 0x010004 temperature 051-001714-02 /
re sensor 02 out of range 051-001714-03
error (0,70) ℃ Master Board PCBA
009-004367-00
TempSensor Wire
Multimeter

Searching for 115-025639-00 1. Perform syringe


the sensor: not Syringe assembly self-test to see whether
Syringe inside the 009-004357-00 the error still exists;
0x02nn01
module sensor area Photosensor Wire for 2. Check the syringe,
01
error after the action Motor syringe assembly,
is completed 009-004355-00 connecting cables, and
(after Syringe Motor Wire main control board in

9-2
Troubleshooting

compensation); 801-3003-00027-00 turn.


10ml syringe (FRU)

2. Leaving the 115-027479-00

sensor area: 250ul syringe (with

0x02nn01 still inside the connector)

02 sensor area 801-3003-00015-00

after the action Motor position

is completed; sensor assembly


(FRU)
051-001714-00 /

0x02nn01 051-001714-02 /
Other error.
03 051-001714-03
Master Board PCBA
Lubricating grease

Searching for 009-004356-00


the sensor: not Sample Motor Wire
0x02nn02 inside the 009-004357-00
1. Perform aspiration
01 sensor area Photosensor Wire for
module self-test to see
after the action Motor
whether the error still
Aspiration is completed; 115-025638-00
exists;
module lift Leaving the Sampling assembly
2. Check the sensor,
mechanis sensor area: 801-3001-00055-00
connecting cables,
m error 0x02nn02 still inside the Sensor assembly 1
main control board, and
02 sensor area 051-001714-00 /
aspiration module in
after the action 051-001714-02 /
turn.
is completed; 051-001714-03

0x02nn02 Master Board PCBA


Other error.
03 Lubricating grease

Current 009-004356-00 1. Perform aspiration


0x02nn03
Aspiration position Sample Motor Wire module self-test to see
01
module unknown; 009-004357-00 whether the error still
rotary Searching for Photosensor Wire for exists;
mechanis 0x02nn0 the target Motor 2. Check the sensor,
m error 302 sensor: not 115-025638-00 connecting cables,

inside the Sampling assembly main control board, and

9-3
Troubleshooting

sensor area 801-3003-00015-00 aspiration module in


after the action Motor position turn.
is completed; sensor assembly
(FRU)
051-001714-00 /

0x02nn0 051-001714-02 /
Other error.
303 051-001714-03
Master Board PCBA
Lubricating grease

The reagent Check related tubes,


Diluent 0x030001 detection reagent, reagent
051-001621-00
ran out 01 reports no detection tube, liquid
Liquid detection
diluent detection board,
board PCBA
connecting cables, and
043-000829-00
main control board in
Reagent detection
turn
tube
Note: Only models
009-004360-00
The reagent BC-30s/31s/20s/21s
Liquid Detect Board
Lyse ran 0x030001 detection are equipped with the
Wire
out 02 reports no 009-004360-00 Liquid
051-001714-00 /
diluent Detect Board Wire,
051-001714-02 /
other models
051-001714-03
(BC-10/11/0e/20/21/30/
Master Board PCBA
31/30e) are not
equipped with this wire.

Floater status: 115-013091-00


1. Check once Waste container cap
in startup, and assembly
the status is 009-004361-00 Float Check the floater,
Waste
0x040001 full; and Aspirate Key connecting cable, and
container
01 2. Check for 3 Wire main control board in
full
times when the 051-001714-00 / turn
analyzer is 051-001714-02 /
idled, and the 051-001714-03
results all show Master Board PCBA

9-4
Troubleshooting

that the status


is full.

115-025649-00
Preheat Diluent heating
Preheat bath Check the diluent
bath assembly
0x050001 temperature heating assembly and
temperatu 051-001714-00 /
01 higher than main control board in
re is too 051-001714-02 /
45℃ turn
high 051-001714-03
Master Board PCBA

115-025649-00
Diluent heating
Preheat Preheat bath assembly Check the connecting
bath temperature is 051-001714-00 / cable of the heater,
0x050001
temperatu 2.0 ℃ lower 051-001714-02 / diluent heating
02
re is too than the target 051-001714-03 assembly, and main
low temperature Master Board PCBA control board in turn
009-004359-00 Heat
Driver Wire

Make sure the ambient


115-015677-00
Diluent temperature falls in the
Diluent temperature
temperatu Diluent claimed running
detection unit
re goes 0x050002 temperature is temperature.
051-001714-00 /
beyond 01 higher than Check the diluent
051-001714-02 /
higher limit 45℃ temperature detection
051-001714-03
limit unit and main control
Master Board PCBA
board in turn.

Diluent Diluent 115-015677-00 Make sure the ambient


0x050002
temperatu temperature is Diluent temperature temperature falls in the
02
re goes lower than limit detection unit claimed running

9-5
Troubleshooting

beyond 5℃ 051-001714-00 / temperature.


lower limit 051-001714-02 / 2. Check the diluent
051-001714-03 temperature detection
Master Board PCBA unit and main control
board in turn.

115-025643-00
1. Go to the Temp &
Waste pump
Pressure screen, and
assembly
check whether the error
115-025641-00
exists;
Vacuum/Pressure
2. Check the waste
Pressure out of Chamber
Vacuum pump and the
0x060001 the range 801-3201-00003-00
pressure connecting cables of
01 specified by 3-way Valve
abnormal the valves and pump in
the sequence (Mindray)
turn.
801-3201-00002-00
3. Check the vacuum
2-way Valve
chamber, valves and
(Mindray)
related tubing in turn for
009-004358-00
leakage.
Valve and pump wire

For single-bath
115-025645-00 WBC
Clogging( 0x070001 WBC aperture analyzers
bath assembly
WBC) 01 voltage high (BC-10/11/10e/20/21):
PROBE CLEANSER
The normal aperture
voltage range is
7.5V-18V (for both
WBC and RBC count)

115-025644-00 RBC For dual-bath


Clogging( 0x070001 RBC aperture
bath assembly analyzers
RBC) 02 voltage high
PROBE CLEANSER (BC-30/31/30e/20s/21s
/30s/31s):

 The normal WBC


aperture voltage
range is

9-6
Troubleshooting

6.5V-14.5V

 The normal RBC


aperture voltage
range is
8.5V-18.8V

1. Check the residual


volume of the diluent
and its model;
2. Check the
measurement bath for
leakage of liquid or gas;
3. Perform probe
cleanser maintenance;
4. Uninstall and clean
the aperture.

1. Check the
instrument, including
whether the earthing
screws are normal, and
whether the shielding
WBC
Detect strong box is open;
channel
0x070006 interfering 2. Search for external
signal /
01 signal in WBC source of interference,
interferenc
channel e.g. whether the
e
external power supply
is stable, and whether
there is any object
nearby producing
strong interference.

RBC 1. Check the


Detect strong
channel instrument, including
0x070006 interfering
signal / whether the earthing
02 signal in RBC
interferenc screws are normal, and
channel
e whether the shielding

9-7
Troubleshooting

box is open;
2. Search for external
source of interference,
e.g. whether the
external power supply
is stable, and whether
there is any object
nearby producing
strong interference.

1. Check the WBC bath


to see whether there is
unexpected substance;
2. Check the WBC bath
for leakage;
115-025640-00 HGB
HGB HGB blank 3. Check whether the
assembly
blank 0x070002 voltage out of exterior of the WBC
115-025645-00 WBC
voltage 01 range [3.85, bath is clean;
bath assembly
abnormal 4.85]V 4. Perform probe
PROBE CLEANSER
cleanser maintenance;
5. Set up HGB gain;
6. Replace the HGB
assembly, and set up
the HGB gain.

Aperture 1. If the diluent


Aperture voltage in WBC temperature sensor
voltage 0x070003 counting 115-025645-00 WBC error is reported at the
abnormal 01 process is bath assembly same time. deal with it
(WBC) lower than first;
7.2V. 2. Check the model of
the diluent;
Aperture
Aperture 3. Check whether there
voltage in RBC
voltage 0x070003 115-025644-00 RBC is leakage or overflow;
counting
abnormal 02 bath assembly 4. Uninstall the
process is too
(RBC) aperture, and make
low
sure the sealing ring is

9-8
Troubleshooting

clean.

1. Make sure the


models of the reagents
are correct;
Startup 2. Make sure the signal
Backgrou
0x070004 background line is grounded safely,
nd PROBE CLEANSER
01 results and the installation of
abnormal
unqualified the shielding box is
reliable;
3. Perform probe
cleanser maintenance;

Please make sure the


machine is well

0x070007 grounded. The power


Power Power line
01 / line should be stable
interfere interference
voltage and power
supply should be
stable.

1. Check the lyse.


2. Check whether the
lyse reagent tube
is bent, clogged, or
Hemolysis 0x070007 Abnormal loosened.
/
abn. 02 lysing 3. Check whether the
solenoid valve of
the lyse reagent
tube is clogged or
damaged.

1. Check the aperture


White Blood Cell of WBC bath.
Aperture 0x070007 Abnormal
Ruby Aperture 2. Replace the WBC
abnormal 03 aperture
3003-20-53970 bath assembly if the
aperture is damaged.

9-9
Troubleshooting

Sys. Abnormal
0x070007
config system / Restart the analyzer
04
abn. configuration

Find instrument Contact the network


IP IP conflicting administrator to
0x080001
address with that of a / re-assign a new IP
01
conflict host in the address and modify the
network setting

No paper
0x090001 No paper or No paper or paper Check whether there is
or paper
01 paper jam jam no paper or paper jam
jam

Other Printer error other Please contact the


0x090001 Other printer
printer than no paper or service department of
02 error
error paper jam the printer supplier.

1. Check whether the


data wire of the printer
Printer not 0x090001 Printer not Printer not is connected properly
connected 03 connected connected to the instrument.
2. Check whether the
printer works properly.

Check whether the


Recorder
Recorder 0x090002 Recorder connecting cable of the
communication
error 01 communication error recorder is properly
error
connected.

1. Check whether there


is no paper in the
No paper in the
No paper No paper in the recorder;
0x090002 recorder or
in recorder or recorder 2. Check whether the
02 recorder cover
recorder cover open front cover of the
open
recorder is properly
closed.

Recorder print 1. Check whether the


Recorder 0x090002 Recorder print head
head recorder print head is
error 03 overheated
overheated overheated;

9-10
Troubleshooting

2. Stop printing before


the print head cools
down.

1. Check whether the


network cable is
1. Network cable not properly connected;
well connected; 2. Check whether the
Communi
2. Network between network between the
cation 0x0A0001 Communicatio
the instrument and instrument and the LIS
disconnec 01 n disconnected
LIS disconnected; 3. system works well;
ted
Incorrect IP address 3. Check the instrument
or port in LIS. IP address and port for
LIS connection are
properly configured.

Make sure the LIS


Protocol
Protocol analyzing system is designed in
Communi analyzing error
0x0A0001 error in the consistence with the
cation in the
02 communication protocol provided by
error communication
process the manufacturer of the
process
instrument

1. Check whether the


LIS 1. Network cable not
network cable is
acknowledgme well connected;
Communi properly connected;
0x0A0001 nt overtime in 2. Communication
cation 2. Check whether the
03 the between LIS and
error network between the
communication instrument
instrument and the LIS
process disconnected.
system works well;

115-025651-00 LCD
assembly (8.4″)
Screen 115-039856-00 LCD
flickering assembly(8.4")
/ / See section 7.9.2
or 009-007651-00
blackout LCD‘s wire
115-025652-00 LCD
assembly (10.4″)

9-11
Troubleshooting

009-007650-00
LCD screen
connecting wire
051-001714-00 /
051-001714-02 /
051-001714-03
Master Board PCBA
Multimeter

021-000271-00
Touch panel resistive
8.4inch 4-wires
009-004655-00
Small touch panel
wire
Screen 801-3110-00184-00
used / / Touch screen, See section 7.9.4
improperly 10.4″
009-004366-00
Touch panel
connection wire
051-000881-00 6301
Touch screen control
board PCBA

9-12
10 Adjustment

10.1 Adjusting Mechanical Positions


Figure 10-1 Point of Criteria of
Step Action
Control Control

Tap "Service > "Sample Probe Debug". Go to


1.1
the screen shown in Figure 10-1.
Tap "Initial position" to make the sample probe Coarse
stays above the WBC bath, and then loosen the adjustment of
4 screws shown in Figure 10-3. sample
1.2 probe
position in
relation to the
This option is not available for single- bath position
bath analyzers
Tap "Middle position" to make the sample probe Fine The sample
come out of the probe wipe. Adjust the position adjustment of probe should
finely to make the sample probe point at the the sample not contact
center of the bath cover, make sure that the probe the bath
1.3
sample probe does not contact the bath position in assembly.
assembly, and then secure the 4 screws. The relation to the The screws
torsion for the screws is 3.2 to 4.5 kgN. bath position should be
well fixed.

10-1
Adjustment

Tap "Initial position", and then "Down position".


Figure 10-2 Figure 10-3 Check whether the sample probe contacts the

RBC bath (not configured for single-


bath. If there is contact, adjust the relative
bath analyzers) position again as instructed by steps in Section
1.4
1.2-1.4, and do the check again to see if the
Adjust the screws in the front position is adjusted properly. The sample probe
and back positions
should not contact the bath cover in the whole
process.

Note:
1. In Figure 10-1, before tapping "Initial position" button, all other buttons are disabled.
Adjust the screws on the left Only after you tap "Initialize", the other three buttons will be enabled. Only after you tap
WBC bath
and right positions
"WBC Bath"/"RBC Bath", the "Middle position" and "Down position" buttons will be
enabled.

10-2
Adjustment

Figure 10-4
Fixture 3008-J02 Probe wipe positioner
Point of Criteria of
Control Control
Steps Action
For dual-bath analyzers, tap "Initial Adjust the 1. The
position" > "RBC Bath" to make the position of the sample
sample probe stays above the RBC bath sample probe in probe
and adjust its position in relation to the relation to the should
RBC bath according to steps 1.2-1.4. RBC bath. not
For single-bath analyzers, skip this step. contact
The sample probe must contact the bottom of the fixing the bath
1.5
device. assemb
ly.
2. The
screws
should
be well
fixed.
Tap "Height-fixed pos." to make the Adjust the The sample
sample probe stays above the WBC bath. position of the probe must
Use the probe wipe positioner to adjust the sample probe in contact the
1.6 position of the sample probe in relation to relation to the probe wipe
the probe wipe as shown in Figure 10-4 probe wipe. positioner.
and Figure 10-5. The torsion for the
screws is 3.2 to 4.5 kgN.

10-3
Adjustment

Figure 10-5 Tap "Initial position", and then randomly Check the The sample
tap "WBC Bath", "Aspiration Pos." and position of the probe should not
1.7
"RBC Bath" to check whether the sample sample probe scratch other
probe scratches other components. components.

Note:
1. Perform step 1.5 for only dual-bath analyzers. The single-bath analyzer does not have
RBC bath, therefore does not require this step.
2. Before positioning the probe wipe, be sure to tap "Height-fixed pos." to make the sample
Fasten the
panhead screws probe stays above the WBC bath because the rotary motor changes the sample probe
on the fixing height in the vertical position. Do not perform height fixing on other positions. It is
device
forbidden to click "WBC Bath" directly.

10-4
Adjustment

10.2 Adjusting Analysis Components


10.2.1 Counting Channel Test
Figure 10-6 Point of
Step Action Criteria of Control
Control
Open the shielding box of the counting
4.1 bath, and run blank counts for several
times in whole blood mode;
Observe the whole counting process, and Aspiration No gas column in the
make sure there is no gas column in the tubing, sample aspiration tubing and
aspiration tubing and no liquid suspended probe, counting sample preparation, no
at the sample probe. Otherwise, replace bath liquid suspended at the
4.2 the tubing. Check and make sure that sample probe, related
there is no gas column in the sample tubes fulfilled with liquid
preparation tubing, and tubes of the WBC without gas column.
This does not exist for
single-bath analyzers bath and RBC bath are fulfilled with liquid
without any bubble.

10-5
Adjustment

Observe the whole counting process, and WBC bath, RBC No splashes when
check whether the liquid level is normal bath dispensing liquid in
after dispensing liquid in WBC/RBC bath; WBC/RBC bath; bubbles
whether the sample probe tip is immersed can be made effectively;
in the liquid when the probe gets into the bubbles does not come
bath, whether there are splashes while into contact with the liquid
4.3
dispensing liquid, and whether there are dispensing tube; sample
bubbles when making bubbles; whether probe tip is immersed in
bubbles come into contact with the liquid the liquid; WBC and RBC
dispensing tube; whether the WBC bath baths can be emptied
and RBC bath can be emptied normally. normally, no liquid reside
on the wall of the bath;
Tap "Service">"Self-Test" to go to the Aperture Aperture voltage normal;
self-test screen shown in Figure 10-6. Tap voltage no error message.
4.4
"Aperture voltage RBC" and "Aperture
voltage WBC".
Install the shielding box of the bath and fix Secure the
4.5 it with M3X8 screws. Secure the screws screws.
using a cross-head screwdriver.
Start the count again. Observe the sample Sample probe Sample probe position in
probe action in the whole process. There position in relation to the bath
4.6 should be no interference between the relation to the shielding box position
sample probe and the shielding box while bath shielding
mixing the liquid in the bath. box position
Note: the gas column mentioned above is a large bubble that divides the liquid into segments in the
tubing.

10-6
Adjustment

10.3 Saving the Settings


To save the modified settings, switch to another screen, the following dialog box will display.

Tap "Yes" to save the settings and switch to the corresponding screen.
Tap "No" to switch to the corresponding screen without saving the settings.

10-7
11 Debugging and Validation After
Servicing
Service
Component Name Adjustment Requirement Validation
Material ID
Master Board 051-001714-00 / 1. Back up the configuration Version information correct
PCBA
051-001714-02 / data as instructed by the
051-001714-03 prompt on the screen;
2. Check the version
information at the "Version
Info" screen.
Syringe transfer 115-020624-00 Calibrate again Check the repeatability
assembly
10ml Syringe 801-3003-00027
-00
Optical Sensor 3101-20-68304
block of injector
special bolt 3 041-005167-00
250ul syringe (with 115-027479-00
nozzle)
Sampling 115-025638-00 1. Make sure that there is Check the repeatability
Assembly
no bent-over of tubes, and

Rotation Motor Pos 801-3003-00015 no interference between the


Sensor Assy tubes and the front plate,
-00
fluidic component partition,

Sensor Package 801-3001-00055 right door, motors, valves,

-00 wire harness retainers


when the aspiration module
is moving vertically or
Sample Probe 801-1805-00004
Wipe Block horizontally;
-00
2. Make sure that the tubes

Sample probe are not deformed when


801-1805-00003
passing through the wire
-00
harness retainers;
3. Make sure that the inlet

11-1
Debugging and Validation After Servicing

and outlet tubes of the


probe wipe are not bent
over and there is no
interference when the
aspiration module is moving
vertically or horizontally;
4. Adjust the mechanical
position of the sample
probe in relation to the
WBC\RBC bath;
5. Calibrate again.
RBC Bath 115-025644-00 1. Adjust the mechanical Check the repeatability
Assembly
position of the sample
probe in relation to the bath;
2. The waste tube of the
bath need to be wound one
lap in the vertical direction,
the height of the twined
tube should be higher than
that of 3ml liquid;
3. Perform gain calibration;
4. Calibrate again.
WBC Bath 115-025645-00 1. Adjust the mechanical 1. Check the repeatability;
Assembly
position of the sample 2. Make sure the HGB
probe in relation to the bath; blank voltage is 4.1V.
2. The waste tube of the
bath need to be wound one
lap in the vertical direction,
the height of the twined
tube should be 3ml liquid
higher than that of counting
tube;
3. Perform gain calibration;
4. Calibrate again.
Single Pass Bath 1. Adjust the mechanical 1. Check the repeatability;
Assembly 115-049501-00

11-2
Debugging and Validation After Servicing

position of the sample 2. Make sure the HGB


probe in relation to the bath; blank voltage is 4.1V.
2. The waste tube of the
bath need to be wound one
lap in the vertical direction,
the height of the twined
tube should be 3ml liquid
higher than that of counting
tube;
3. Perform gain calibration;
4. Calibrate again.
Shielding bottom 042-011786-00 Adjust the mechanical Make sure that the
plate welding piece
position of the RBC bath aspiration module does not
come into contact with the
RBC bath when it moves up
and down above the RBC
bath
HGB assembly 115-025640-00 Perform HGB gain Make sure the HGB blank
calibration voltage is 4.1V.
Vacuum/Pressure 115-025641-00 / Make sure that bath can be
Chamber
emptied normally, and
Waste pump 115-025643-00
vacuum can be built up
assembly
normally.
2-way Valve 801-3201-00002 / 1. Make sure the inlet and
(Mindray)
-00 outlet are in correct
3-way Valve 801-3201-00003 directions;
(Mindray)
-00 2. The rubber tube should
be inserted to the bottom;
3. If a wide 50 tube
connected to a valve or
connector is unplugged,
discard it and use a new
one for reconnection.
SMC 3-way 115-015967-00 / 1. Make sure that the
valve(3106)
connections to N.C, N.O,

11-3
Debugging and Validation After Servicing

and public ends are correct;


2. The rubber tube should
be inserted to the end;
3. If a wide 50 tube
connected to a valve or
connector is unplugged,
discard it and use a new
one for reconnection.
Panel assembly 043-005464-00 Perform screen calibration Make sure that the touch
(BC-30S)
screen works properly
10 Inch Touch
Screen Long 047-005527-00
Gasket
10 Inch Touch
Screen Short 047-005528-00
Gasket
Nel 043-007675-00
assembled(BC-20S)
Long Gasket, IPM8
047-005535-00
Touch Screen
Short Gasket, IPM8
047-005536-00
Touch Screen
Touch screen, 801-3110-00184
10.4″
-00
Touch panel 021-000271-00
resistive 8.4 inch
4-wires
LCD assembly 115-025652-00
(10.4″)
LCD assembly 115-039856-00
(8.4″)
Reagent pre-heater 115-049623-00 1. The J9 and 3-way Make sure that the
assembly
connector C10 must be temperature values are in
inserted to the end; specified ranges at the
2. Enter the parameters status screen
recorded by FRU in the
temperature calibration
screen to attain new
temperature values.

11-4
Debugging and Validation After Servicing

Lithium battery 3V M05-010R03--- Set time and date at the The date displayed after
35mAh D12.5*2.0
Date/Time Setup screen. restarting the analyzer is
Save the setting and shut the same as that before the
down the analyzer. shutdown.
SD card 8GB 023-001056-00 1. Back up the data before /
Class10
replacing the SD card (if
possible);
2. Restore the configuration
data.

11-5
12 Service BOM
ID Name
115-025638-00 Sampling assembly
021-000271-00 touchpanel resistive 8.4inch 4-wires
023-000866-00 Handheld Barcode Scanner
023-001524-00 SDcard 8GB Class10
024-001032-00 FAN 12Vdc 40*40*10MM 4.1cfm 25dB 300mm
041-020880-00 Swab adjuster
042-005948-00 top signal shield
042-005949-00 bottom signal shield
042-011528-00 shielding box
042-011531-00 key mounting plate
042-020906-00 right door(3008)
042-020086-00 right door (3011, 3012)
042-011538-00 top cover
042-020088-00 top cover (3011, 3012)
043-000711-00 filter
043-000829-00 reagent detection tube
043-007675-00 nel assembled(BC-20S)
043-005463-00 panel assembled(BC-20S)
043-005464-00 panel assembled(BC-30S)
043-005810-00 [Aspirate] key(BC-20S)
043-008994-00 key(BC-30S)
043-005587-00 Front Cover(10inches for bid)
043-007674-00 Front Cover(8inches for bid)
043-008298-00 front cover (BC-10)
043-008299-00 front cover (BC-20)
043-008406-00 front cover (BC-11)
043-008407-00 front cover (BC-21)
043-008300-00 front cover (BC-30)
043-008408-00 front cover (BC-31)
043-009251-00 front cover (BC-30e)
043-010034-00 front cover (BC-10e)
047-005535-00 LONG GASKET, IPM8 TOUCH SREEN
047-005536-00 SHORT GASKET, IPM8 TOUCH SREEN
047-016362-00 10INCH TOUCHSCREEN LONG GASKET
047-016363-00 10INCH TOUCHSCREEN SHORT GASKET
051-001621-00 Liquid detect board PCBA
051-001714-00 Master Board PCBA
051-001714-02 Master Board PCBA
051-001714-03 Master Board PCBA
051-001857-00 3008 indicate board PCBA
051-001319-00 3107 Power Source PCBA
051-002708-00 3206 Power Board PCBA for Burning

12-1
Service BOM

051-002911-00 3008 Power Supply PCBA


115-013091-00 waste capsule assembly
115-015677-00 diluent temperature detecting asm
115-015967-00 SMC 3-way valve(3106)
115-025639-00 Syringe assembly
115-025640-00 HGB module
115-025641-00 Vacuum/Pressure Chamber
115-025642-00 Reagent detector assembly
115-025643-00 Waste pump assembly
115-025644-00 RBC Bath Assembly
115-025645-00 WBC Bath Assembly
115-049501-00 Single Pass Bath Assembly
115-050158-00 Single Pass Bath Assembly(no Cell Ruby )
Power box assembly (applicable to analyzers
with software versions earlier than
115-025646-00 V01.07.00.2179)
power pack assembly (applicable to analyzers
115-054722-00 with software version V01.07.00.2179 and later)
115-025647-00 [Aspirate] key assembly
115-025648-00 Left Door Assembly
115-045852-00 Left Door Assembly (3011, 3012)
115-049564-00 Left Door Assembly (3008)
115-025649-00 Reagent pre-heater assembly
115-049623-00 Reagent pre-heater assembly
115-025651-00 LCD assembly(8.4")
115-025652-00 LCD assembly(10.4")
115-025654-00 Front cover assembly(10.4")
115-027955-00 Front housing assembly(BC-31S)
115-039857-00 Front housing assembly(BC-21S)
115-039858-00 Front cover assembly(8.4")
115-045934-00 Front cover assembly(BC-10)
115-045935-00 Front cover assembly(BC-20)
115-045936-00 Front cover assembly(BC-30)
115-046023-00 Front cover assembly(BC-11)
115-046024-00 Front cover assembly(BC-21)
115-046025-00 Front cover assembly(BC-31)
115-039856-00 LCD assembly(8.4")
115-039901-00 Display Module
115-025715-00 Air pump assembly
115-027479-00 250ul syringe(with nozzle)
115-028170-00 tube package
115-028171-00 connector package
115-030832-00 SD Card
115-036143-00 Preventive maintenance material pack
115-066737-00 SD card(dual aperture)
115-066735-00 SD card(single aperture)

12-2
Service BOM

801-1805-00003-00 Sample Probe


801-1805-00004-00 SAMPLE PROBE WIPE BLOCK
801-1805-00023-00 Isolation Chamber
801-2800-00016-00 Recorder Module
801-2800-00018-00 CAP Component for Diluent
115-064342-00 CAP Component for Diluent
801-3001-00055-00 sensor package
801-3003-00015-00 Rotation Motor Pos Sensor Assy
801-3003-00027-00 10ml Syringe
801-3007-00014-00 3007 switch(FRU)
801-3007-00029-00 3007 CAP Component for LYSE(FRU)
801-3110-00167-00 Support panel for diluent bottle
801-3110-00184-00 Touch screen 10.4'
021-000279-00 Touch screen 10.4" 4-line
801-3201-00002-00 2-way Valve (Mindray)
801-3201-00003-00 3-way Valve (Mindray)
M05-010R03--- Lithium battery 3V 35mAh D12.5*2.0
M07-00131F--- FUSE Time-lag 250V 3.15AD5X20
M6G-020006--- Tubing,Silicone,1/16"ID,1'
M6G-020056--- Tube EVA,ID:1/16",OD:1/8",clear
M90-000026--- Tube.PTFE,1/32"X1/16",3000074,100ft/coil
M90-100009--- FemaleLuer,1/4-28UNF,1/8"ID
M90-100012--- Lock Nut, 1/4-28UNF, White Nylon
M90-100014--- LockNut, 1/4-28UNF, Red Nylon
M90-100026--- Male LuerPlug, White
M90-100027--- StraightReduction,1/8"&3/32"ID
M90-100028--- Tee,400Barb,3/32"ID,White Nylon
M90-100028-01 Straight,400Barb,3/32"ID,White
M90-100028-03 Y,400Barb,3/32"ID,White Nylon
M90-100031--- tube.PTFE,1.7mmIDX2.55mmOD
M90-100048--- Coded LockRing, White
M90-100050--- Coded Lock Ring, For FTLLB or FTLB, Red
M90-100066--- Elbow Reduction,1/8"&3/32"ID,White
M90-100071--- Tubing.3/32"X5/32",ND-100-65,Tygon

12-3
13 Appendices
A. Fluidic diagram
As shown in the following fluidic diagram, the red line indicates the lyse routing in the fluidic.
1. For BC-30s/31s/20s/21s: The lyse is aspirated from the lyse bottle by the 10ml syringe, passes through tubes T48, T54, T47, and valve SV07 and enters
tube T6 for storage. Then, the lyse is pushed forwarded by the 10ml syringe and goes through T6, SV07, T7, and T8 to WBC bath to react.
2. For BC-30/31/30e: The lyse is aspirated from the lyse bottle by the 10ml syringe, passes through tubes T48, T54, and valve SV07, and enters tube T6 for
storage. Then, the lyse is pushed forwarded by the 10ml syringe and goes through T6, SV07, T7, and T8 to WBC bath to react.
3. For BC-20/21/10/11/10e: The lyse is aspirated from the lyse bottle by both the 10ml syringe and 250ul syringe, passes through tubes T15, T14, and valve
SV07, and enters tube T12 for storage. Then, the lyse is pushed forwarded by the 10ml syringe and 250ul syringe through T12, SV07, T19, and T20 to
WBC bath to react.

A-1
Fluidic Diagram

Reagent
detectio
n C23
T47 T7

SV07

T54
T11 C4

T13
T23
C5

T8
T6

T58
SV05 WBC RBC

C22
C2

T24
T5

T19
T48

Preheat

J3-T34-
J1-T33-
bath

T25
J9-T52-J10

J4
J2
chamber
Isolation
C13 C7

chamber2
C6

T10

Isolation
T14
C14 T35 T36

J12-T51-P1
T4

1
Lyse bottle
T49 T49

SV02 T59 T60


C1

T20
T3

T61

T38
T37
C25 SV04
C26

T56

T57
C3 SPB SV09 SV08
SV06

T26
Temperateu

T12

C15
re sensor

T17
T39
T43
T2

T42

T40
T21
T9 T16 C10 C11

C8 C9

J5-T44-

J7-T45-
T22

T27

T41

J6

J8
SV03 T28
SV01
C24
T55
T15

T29
T1

C12

C21

T46
VC

T53
C17
C18 Transducer GP

T32
containe
Diluent

WASTE
T50

T30
Waste LP
r

C20 C19
SR container T31

Figure 13-1 Fluidic diagram for BC-30s/31s/20s/21s

A-2
Fluidic Diagram

T54
T7

T10
SV07

T23

T8
T6
SV05 WBC RBC

T58
C22
C2

T24
T5

T19
T48

J3-T34-J4
J1-T33-J2

T25
J9-T52-J10
C13 C6 C7
T35 T36

J11-T51-P1
T4
C14

chamber 1

chamber
Isolation
Isolation
Lyse bottle

T49 T49

2
SV02 T59 T60
C1

T20
T3

T37

T38
T61
C25 SV04 C26

T56

T57
C3 SPB SV09 SV08
SV06

T26
T12

C15
Temperature

T43

T17

T40
sensor

T42
T2

T9 C10 C11
T16

T21
T39
C8 C9

J5-T44-J6

J7-T45-J8
T22

T27

T41
SV01 SV03 T28
T55 C24
T15

T29
T1

C12

C21

T46
VC

T53
C17
Transducer GP

T32
C18
container

WASTE
Diluent
T50

T30
Waste LP
container C20 C19
SR T31

Figure 13-2 Fluidic diagram for BC-30/31/30e

A-3
Fluidic Diagram

C4
T14
C6

T12
T19 PS
C25 V07 V04 T27
T17
T47 T20 T23 C13 C14
T26
C5 T21 C12
Prehe
T50
at bath
T25
T24 C17
T48 WBC T29
T15 V06 T46 T49
V05 T33

T11 C24
T9 VAC
T10

TS
T18

T28 PUMP_PRES
J1-T4-J2 T22 S

J5-T34-J6
T16

V01 V02

J7-T6-P1
T30
T35
Isolation T37
C18 C15
T3 chamber C2
T1 T7
T36 T51 0 T45 C16
T32 J3-T31-J4

T2 V09
SPB
C8 C10
C11
ASP(250uL)
DIL 10mL

C9
C19
T44

SR
Lyse T43

T8 T38
Probe
containe

wipe
Diluent
bottle

V08
r

T42
T39
C21 C22 C23 Waste
T40 T41
container

PUMP_WASTE

Figure 13-3 Fluidic diagram for BC-20/21/10/11/10e

A-4
B. Connection and Tube
List of Materials in the Fluidic Diagram for BC-30s/31s/20s/21s

Name in the
No. Material Type Material ID Unit Quantity
Diagram

1 Syringe SR 115-015652-00 EA 1
2 WBC bath WBC 115-025645-00 EA 1
3 RBC bath RBC 115-025644-00 EA 1
Vacuum
4 VC 115-015673-00 EA 1
chamber
5 Liquid pump LP 3001-10-07252 EA 1
6 Gas pump GP 082-002497-00 EA 1
7 Sample probe SPB 3001-10-07059 EA 1
8 Probe wipe Probe wipe 3001-30-06957 EA 1
Isolation Isolation
9 115-002439-00 EA 1
chamber chamber 1
Isolation Isolation
10 3003-20-34949 EA 1
chamber chamber 2
Preheating
11 Heating bath 115-009948-00 EA 1
bath
Temperature
12 Sensor 115-015677-00 EA 1
sensor
Electromagnetic
13 SV1 115-010088-00 EA 1
valve
Electromagnetic
14 SV2 115-015967-00 EA 1
valve
Electromagnetic
15 SV3 115-010089-00 EA 1
valve
Electromagnetic
16 SV4 115-010089-00 EA 1
valve
Electromagnetic
17 SV5 115-010088-00 EA 1
valve
Electromagnetic
18 SV6 115-010088-00 EA 1
valve
Electromagnetic
19 SV7 115-010088-00 EA 1
valve
Electromagnetic
20 SV8 115-010088-00 EA 1
valve
Electromagnetic
21 SV9 115-010088-00 EA 1
valve
22
23
24

B-1
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30s/31s/20s/21s


Name in
No. Material Type the Material ID Unit Quantity
Diagram
25 Rubber tube T1 082-000108-00 mm 240
26 Rubber tube T2 082-000108-00 mm 210
27 Rubber tube T3 082-000108-00 mm 270
28 Rubber tube T4 082-000314-00 mm 20
29 Rubber tube T5 082-000314-00 mm 20
30 Rubber tube T6 3001-10-07069 mm 450
31 Rubber tube T7 3001-10-07069 mm 60
32 Rubber tube T8 3001-10-07069 mm 65
33 Rubber tube T9 082-000108-00 mm 50
34 Rubber tube T10 M6G-020055--- mm 1200
35 Rubber tube T11 082-000108-00 mm 50
36 Rubber tube T12 082-000108-00 mm 20
37 Rubber tube T13 082-000108-00 mm 20
38 Rubber tube T14 M6G-020055--- mm 270
39 Rubber tube T15 M6G-020055--- mm 1500
40 Rubber tube T16 082-000108-00 mm 440
41 Rubber tube T17 082-000108-00 mm 230
42 Rubber tube T19 3001-10-07069 mm 300
43 Rubber tube T20 3001-10-07069 mm 465
44 Rubber tube T21 3001-10-07069 mm 235
45 Rubber tube T22 M90-100071--- mm 390
46 Rubber tube T23 3001-10-07069 mm 240
47 Rubber tube T24 3001-10-07069 mm 180
48 Rubber tube T25 3001-10-07069 mm 120
49 Rubber tube T26 3001-10-07069 mm 320
50 Rubber tube T27 082-000314-00 mm 20
51 Rubber tube T28 082-000314-00 mm 60
52 Rubber tube T29 M90-100071--- mm 300
53 Rubber tube T30 082-000314-00 mm 120
54 Rubber tube T31 082-000314-00 mm 100

B-2
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30s/31s/20s/21s

Name in the
No. Material Type Material ID Unit Quantity
Diagram

55 Rubber tube T32 M6G-020055--- mm 1500


56 Rubber tube T33 M90-100031--- mm 160
57 Rubber tube T34 M90-100031--- mm 160
58 Rubber tube T35 M6G-020006--- mm 20
59 Rubber tube T36 M6G-020006--- mm 20
60 Rubber tube T37 M90-100071--- mm 80
61 Rubber tube T38 M90-100071--- mm 140
62 Rubber tube T39 M90-100071--- mm 70
63 Rubber tube T40 M90-100071--- mm 30
64 Rubber tube T41 M90-100071--- mm 130
65 Rubber tube T42 M90-100071--- mm 140
66 Rubber tube T43 M90-100071--- mm 90
67 Rubber tube T44 082-000109-00 mm 220
68 Rubber tube T45 082-000109-00 mm 380
69 Rubber tube T46 M6G-020006--- mm 80
70 Rubber tube T47 3001-10-07069 mm 420
71 Rubber tube T48 3001-10-07069 mm 300
72 Rubber tube T49 A21-000002--- mm 180
73 Rubber tube T50 082-000314-00 mm 300
74 Rubber tube T51 082-000422-00 mm 400
75 Rubber tube T52 M90-100031--- mm 700
76 Rubber tube T53 3001-10-07069 mm 40
77 Rubber tube T54 3001-10-07069 mm 600
78 Rubber tube T55 M90-100071--- mm 45
79 Transfer tube T56 M6G-020006--- mm 15
80 Transfer tube T57 M6G-020006--- mm 15
81 Transfer tube J1 M90-100071--- mm 25
82 Transfer tube J2 M6G-020006--- mm 25
83 Transfer tube J3 M90-100071--- mm 25
84 Transfer tube J4 M6G-020006--- mm 25

B-3
Connection and Tube

Lis t of Materials in the Fluidic Diagram for BC-


30s /31s /20s /21s

Material
No. Material Ty pe Material ID Unit Quantity
Ty pe

85 Transfer tube J5 082-000710-00 mm 20


86 Transfer tube J6 082-000710-00 mm 20
87 Transfer tube J7 082-000710-00 mm 20
88 Transfer tube J8 082-000710-00 mm 20
89 Transfer tube J9 082-000055-00 mm 20
90 Transfer tube J10 0030-20-13339 mm 20
91 Transfer tube J11 082-000055-00 mm 20
92 Transfer tube J12 082-000710-00 mm 20
93 Silicone Tube P1 082-000108-00 mm 200
94 Tube Connector C1 M90-100066--- EA 1
95 Tube Connector C2 M90-100027--- EA 1
96 Tube Connector C3 M90-100027--- EA 1
97 Tube Connector C4 M90-100066--- EA 1
98 Tube Connector C5 M90-100027--- EA 1
99 Tube Connector C6 M90-100026--- EA 1
100 Tube Connector C7 M90-100026--- EA 1
101 Tube Connector C8 M90-100027--- EA 1
102 Tube Connector C9 M90-100028--- EA 1
103 Tube Connector C10 M90-100028-01 EA 1
104 Tube Connector C11 M90-100028-01 EA 1
105 Tube Connector C12 M90-100028-03 EA 1
106 Tube Connector C13 M90-100024--- EA 1
107 Tube Connector C14 M90-100009--- EA 1
108 Tube Connector C15 M6Q-030111--- EA 1
109 Tube Connector C16 M90-100009--- EA 1
110 Tube Connector C17 M6Q-030111--- EA 1
111 Tube Connector C18 M90-100009--- EA 1
112 Tube Connector C21 M90-100028-01 EA 1
113 Tube Connector C22 043-000892-00 EA 1
114 Tube Connector C23 043-000892-00 EA 1
115 Tube Connector C24 M90-100100--- EA 1
116 Tube Connector C25 M90-100027--- EA 1
117 Tube Connector C26 M90-100027--- EA 1
B-4
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30s/31s/20s/21s


Name in the
No. Material Type Material ID Unit Quantity
Diagram
118 Rubber tube T58 3001-10-07069 mm 40
119 Rubber tube T59 M90-100071--- mm 120
120 Rubber tube T60 M90-100071--- mm 60
121 Rubber tube T61 3001-10-07069 mm 240

B-5
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30/31/30e

Name in the
No. Material Type Material ID Unit Quantity
Diagram

1 Syringe SR 115-015652-00 EA 1
2 WBC bath WBC 115-025645-00 EA 1
3 RBC bath RBC 115-025644-00 EA 1
Vacuum
4 VC 115-015673-00 EA 1
chamber
5 Liquid pump LP 3001-10-07252 EA 1
6 Gas pump GP 082-002497-00 EA 1
7 Sample probe SPB 3001-10-07059 EA 1
8 Probe wipe Probe wipe 3001-30-06957 EA 1
Isolation Isolation
9 115-002439-00 EA 1
chamber chamber 1
Isolation Isolation
10 3003-20-34949 EA 1
chamber chamber 2
Preheating
11 Heating bath 115-009948-00 EA 1
bath
Temperature
12 Sensor 115-015677-00 EA 1
sensor
Electromagnetic
13 SV1 115-010088-00 EA 1
valve
Electromagnetic
14 SV2 115-015967-00 EA 1
valve
Electromagnetic
15 SV3 115-010089-00 EA 1
valve
Electromagnetic
16 SV4 115-010089-00 EA 1
valve
Electromagnetic
17 SV5 115-010088-00 EA 1
valve
Electromagnetic
18 SV6 115-010088-00 EA 1
valve
Electromagnetic
19 SV7 115-010088-00 EA 1
valve
Electromagnetic
20 SV8 115-010088-00 EA 1
valve
Electromagnetic
21 SV9 115-010088-00 EA 1
valve
22
23
24

B-6
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30/31/30e


Name in
No. Material Type the Material ID Unit Quantity
Diagram
25 Rubber tube T1 082-000108-00 mm 240
26 Rubber tube T2 082-000108-00 mm 210
27 Rubber tube T3 082-000108-00 mm 270
28 Rubber tube T4 082-000314-00 mm 20
29 Rubber tube T5 082-000314-00 mm 20
30 Rubber tube T6 3001-10-07069 mm 450
31 Rubber tube T7 3001-10-07069 mm 60
32 Rubber tube T8 3001-10-07069 mm 65
33 Rubber tube T9 082-000108-00 mm 50
34 Rubber tube T10 M6G-020055--- mm 1200
35 Rubber tube T12 082-000108-00 mm 20
36 Rubber tube T15 M6G-020055--- mm 1500
37 Rubber tube T16 082-000108-00 mm 440
38 Rubber tube T17 082-000108-00 mm 230
39 Rubber tube T19 3001-10-07069 mm 300
40 Rubber tube T20 3001-10-07069 mm 465
41 Rubber tube T21 3001-10-07069 mm 235
42 Rubber tube T22 M90-100071--- mm 390
43 Rubber tube T23 3001-10-07069 mm 240
44 Rubber tube T24 3001-10-07069 mm 180
45 Rubber tube T25 3001-10-07069 mm 120
46 Rubber tube T26 3001-10-07069 mm 320
47 Rubber tube T27 082-000314-00 mm 20
48 Rubber tube T28 082-000314-00 mm 60
49 Rubber tube T29 M90-100071--- mm 300
50 Rubber tube T30 082-000314-00 mm 120
51 Rubber tube T31 082-000314-00 mm 100
52 Rubber tube T32 M6G-020055--- mm 1500
53 Rubber tube T33 M90-100031--- mm 160
54 Rubber tube T34 M90-100031--- mm 160

B-7
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30/31/30e

Name in
No. Material Type the Material ID Unit Quantity
Diagram
55 Rubber tube T35 M6G-020006--- mm 20
56 Rubber tube T36 M6G-020006--- mm 20
57 Rubber tube T37 M90-100071--- mm 80
58 Rubber tube T38 M90-100071--- mm 140
59 Rubber tube T39 M90-100071--- mm 70
60 Rubber tube T40 M90-100071--- mm 30
61 Rubber tube T41 M90-100071--- mm 130
62 Rubber tube T42 M90-100071--- mm 140
63 Rubber tube T43 M90-100071--- mm 90
64 Rubber tube T44 082-000109-00 mm 220
65 Rubber tube T45 082-000109-00 mm 380
66 Rubber tube T46 M6G-020006--- mm 80
67 Rubber tube T48 3001-10-07069 mm 300
68 Rubber tube T49 A21-000002--- mm 180
69 Rubber tube T50 082-000314-00 mm 300
70 Rubber tube T51 082-000422-00 mm 400
71 Rubber tube T52 M90-100031--- mm 700
72 Rubber tube T53 3001-10-07069 mm 40
73 Rubber tube T54 3001-10-07069 mm 600
74 Rubber tube T55 M90-100071--- mm 45
75 Transfer tube T56 M6G-020006--- mm 15
76 Transfer tube T57 M6G-020006--- mm 15
77 Transfer tube J1 M90-100071--- mm 25
78 Transfer tube J2 M6G-020006--- mm 25
79 Transfer tube J3 M90-100071--- mm 25
80 Transfer tube J4 M6G-020006--- mm 25
81 Transfer tube J5 082-000710-00 mm 20
82 Transfer tube J6 082-000710-00 mm 20
83 Transfer tube J7 082-000710-00 mm 20
84 Transfer tube J8 082-000710-00 mm 20

B-8
Connection and Tube

List of Materials in the Fluidic Diagram for BC-30/31/30e

Name in the
No. Material Type Material ID Unit Quantity
Diagram
85 Transfer tube J9 082-000055-00 mm 20
86 Transfer tube J10 0030-20-13339 EA 1
87 Transfer tube J11 082-000710-00 mm 20
88 Silicone Tube P1 082-000108-00 mm 200
89 Tube connector C1 M90-100066--- EA 1
90 Tube connector C2 M90-100027--- EA 1
91 Tube connector C3 M90-100027--- EA 1
92 Tube connector C6 M90-100026--- EA 1
93 Tube connector C7 M90-100026--- EA 1
94 Tube connector C8 M90-100027--- EA 1
95 Tube connector C9 M90-100028--- EA 1
96 Tube connector C10 M90-100028-01 EA 1
97 Tube connector C11 M90-100028-01 EA 1
98 Tube connector C12 M90-100028-03 EA 1
99 Tube connector C13 M90-100024--- EA 1
100 Tube connector C14 M90-100009--- EA 1
101 Tube connector C15 M6Q-030111--- EA 1
102 Tube connector C16 M90-100009--- EA 1
103 Tube connector C17 M6Q-030111--- EA 1
104 Tube connector C18 M90-100009--- EA 1
105 Tube connector C21 M90-100028-01 EA 1
106 Tube connector C22 043-000892-00 EA 1
107 Tube connector C24 M90-100100--- EA 1
108 Tube connector C25 M90-100027--- EA 1
109 Tube connector C26 M90-100027--- EA 1
110 Rubber tube T58 3001-10-07069 mm 40
111 Rubber tube T59 M90-100071--- mm 120
112 Rubber tube T60 M90-100071--- mm 60
113 Rubber tube T61 3001-10-07069 mm 240

B-9
Connection and Tube

List of Materials in the Fluidic Diagram for BC-20/21/10/11/10e


Name in the
No. Material Type Material ID Unit Quantity
Diagram
1 Rubber tube T1 082-000108-00 mm 240
2 Rubber tube T2 082-000108-00 mm 270
3 Rubber tube T3 082-000108-00 mm 220
4 Rubber tube T4 M90-100031--- mm 460
5 Rubber tube T6 082-000422-00 mm 400
6 Rubber tube T7 3001-10-07069 mm 320
7 Rubber tube T8 3001-10-07069 mm 430
8 Rubber tube T9 082-000108-00 mm 95
9 Rubber tube T10 082-000108-00 mm 130
10 Rubber tube T11 3001-10-07069 mm 270
11 Rubber tube T12 3001-10-07069 mm 450
12 Rubber tube T14 3001-10-07069 mm 600
13 Rubber tube T15 3001-10-07069 mm 300
14 Rubber tube T16 082-000108-00 mm 50
15 Rubber tube T17 M6G-020055--- mm 420
16 Rubber tube T18 M6G-020055--- mm 1500
17 Rubber tube T19 3001-10-07069 mm 60
18 Rubber tube T20 3001-10-07069 mm 65
19 Rubber tube T21 3001-10-07069 mm 120
20 Rubber tube T22 3001-10-07069 mm 120
21 Rubber tube T23 3001-10-07069 mm 230
22 Rubber tube T24 082-000314-00 mm 20
23 Rubber tube T25 M90-100071--- mm 45
24 Rubber tube T26 M90-100071--- mm 300
25 Rubber tube T27 3001-10-07069 mm 40
26 Rubber tube T28 M90-100071--- mm 230
27 Rubber tube T29 082-000314-00 mm 60
28 Rubber tube T30 M6G-020006--- mm 80
29 Rubber tube T31 082-000109-00 mm 460
30 Rubber tube T32 082-000108-00 mm 320

B-10
Connection and Tube

List of Materials in the Fluidic Diagram for BC-20/21/10/11/10e

Name in
Material
No. the Material ID Unit Quantity
Type
Diagram
31 Rubber tube T33 M6G-020006--- mm 20
32 Rubber tube T34 M90-100031--- mm 160
33 Rubber tube T35 M6G-020006--- mm 20
34 Rubber tube T36 M90-100071--- mm 120
35 Rubber tube T37 082-000314-00 mm 40
36 Rubber tube T38 M90-100071--- mm 250
37 Rubber tube T39 M90-100071--- mm 260
38 Rubber tube T40 082-000314-00 mm 30
39 Rubber tube T41 082-000314-00 mm 120
40 Rubber tube T42 M6G-020055--- mm 1500
41 Rubber tube T43 A21-000002--- mm 180
42 Rubber tube T44 082-000314-00 mm 300
43 Rubber tube T45 M6G-020006--- mm 15
44 Rubber tube T46 082-000314-00 mm 20
45 Rubber tube T47 082-000314-00 mm 20
46 Rubber tube T48 082-000108-00 mm 20
47 Rubber tube T49 3001-10-07069 mm 240
48 Rubber tube T50 3001-10-07069 mm 240
49 Rubber tube T51 M90-100071--- mm 80
50 Rubber tube J1 082-000055-00 mm 20
51 Rubber tube J2 0030-20-13339 EA 1
52 Rubber tube J3 082-000710-00 mm 20
53 Rubber tube J4 082-000710-00 mm 20
54 Rubber tube J5 M90-100071--- mm 25
55 Rubber tube J6 M6G-020006--- mm 25
56 Rubber tube J7 082-000710-00 mm 20
57 Rubber tube P1 082-000108-00 mm 200

B-11
Connection and Tube

List of Materials in the Fluidic Diagram for BC-20/21/10/11/10e

Name in
Material
No. the Material ID Unit Quantity
Type
Diagram
58 Transfer tube C4 043-000892-00 EA 1
59 Transfer tube C5 M90-100027--- EA 1
60 Transfer tube C6 M6Q-030111--- EA 1
61 Transfer tube C7 M90-100009--- EA 1
62 Transfer tube C8 082-001140-00 EA 1
63 Transfer tube C9 082-001141-00 EA 1
64 Transfer tube C10 M6Q-030111--- EA 1
65 Transfer tube C11 M90-100009--- EA 1
66 Transfer tube C12 M90-100027--- EA 1
67 Transfer tube C13 M90-100100--- EA 1
68 Transfer tube C14 M90-100028-01 EA 1
69 Transfer tube C15 M90-100028-01 EA 1
70 Transfer tube C16 M90-100028-01 EA 1
71 Transfer tube C17 M90-100026-- EA 1
72 Transfer tube C18 M90-100026-- EA 1
73 Transfer tube C19 M90-100027--- EA 1
74 Transfer tube C20 M90-100027--- EA 1
75 Transfer tube C21 M90-100027--- EA 1
76 Transfer tube C22 M6G-030111--- EA 1
77 Transfer tube C23 M90-100009--- EA 1
78 Transfer tube C24 M90-100066--- EA 1
79 Transfer tube C25 M90-100027--- EA 1

B-12
Connection and Tube

List of Materials in the Fluidic Diagram for BC-20/21/10/11/10e


Name in the
No. Material Type Material ID Unit Quantity
Diagram
80 Syringe SR 115-015652-00 EA 1
81 WBC bath WBC 115-025645-00 EA 1
82 Vacuum chamber VAC 115-015673-00 EA 1
83 Liquid pump PUMP_WASTE 3001-10-07252 EA 1
84 Gas pump PUNP_PRSS 082-002497-00 EA 1
85 Sample probe SPB 3001-10-07059 EA 1
86 Probe wipe Probe wipe 3001-30-06957 EA 1
Isolation Isolation
87 115-002439-00 EA 1
chamber chamber
Temperature
88 Sensor 115-015677-00 EA 1
sensor
Electromagnetic
89 SV1 115-010088-00 EA 1
valve
Electromagnetic
90 SV2 115-015967-00 EA 1
valve
Electromagnetic
91 SV4 115-010089-00 EA 1
valve
Electromagnetic
92 SV5 115-010088-00 EA 1
valve
Electromagnetic
93 SV6 115-010088-00 EA 1
valve
Electromagnetic
94 SV7 115-010088-00 EA 1
valve
Electromagnetic
95 SV8 115-010088-00 EA 1
valve
Electromagnetic
96 SV9 115-010088-00 EA 1
valve

B-13
C. Hardware block diagram
Aspiration Syringe
Valves & Liquid
Assembly Assembly Preheating
Pumps Detection Floater
MotorX2 MotorX1 X1
X16 X2
SensorX3 SensorX1

Grounding 009-004358-00
009-004359-00

009-004357-00
Power 009-004354-00
009-004355-00
009-004360-00 009-004361-00

Board
009-004357-00
009-004356-00
Aspirate
009-004361-00
Key
Power Power Liquid Floater&
Motor Sensor
Source Driving Detection Aspiration

009-004362-00
Recorder
Recorder (Side
Door)

Camera Indicator 009-004363-00


Board Indicator
Board

USB USB
009-004364-00
009-004471-00
LCD
Front
LVDS Cover
Backlight

Main Control
LCD Touch
Screen
Touch (Transfer Earthing
Digital Screen Connection)
Power 009-004366-00

Board
009-004655-00

Preheating
US Bth
B
Vacuum
US 009-004367-00 Chamber
B Atmospheric
HGB Temperature
051-001714-00 Pressure Diluent
009-004368-00
LA
N

009-004369-00
RBC RBC
Bath

Shielding
009-004370-00 Box
Analog WBC
Power WBC
Bath

Note: The RBC bath applies to BC-30s/31s/20s/21s/30/31/30e only. BC-20/21/10/11/10e is not


configured with the RBC bath.
Only models BC-30s/31s/20s/21s provide the liquid detection function. Other models
30/31/30e/20/21/10/11/10e are not equipped with the 009-004360-00 Liquid Detect Board
Wire.

C-1
D. Cables and Wires
Connecting
Socket on
Material ID Name the Main Connection
Control
Board
Syringe Motor Connects 115-025639-00 Syringe
009-004355-00
Wire J8 assembly
Connects 115-025638-00 Sampling
Sample Motor assembly
009-004356-00
Wire UP: connects upper motor
J7 DOWN: connects down motor
Connects 115-025638-00 Sampling
assembly
UP: connects upper photosensor of
sampling assembly
Photosensor
009-004357-00 LEFT: connects left photosensor of
Wire for Motor
sampling assembly
RIGHT: connects right photosensor of
sampling assembly
J12 INJ: connects syringe photosensor
V1~V10: connects the valve
corresponding to the division plate
printing
Valve and Pump
009-004358-00 GAS: connects 115-025715-00 air pump
Wire
assembly
WAS: connects 115-025643-00 waste
J9 pump assembly
Connects 115-025649-00 Reagent
pre-heater assembly
009-004359-00 Heat Driver Wire
HT: connects the heater
J11 TS: connects the Thermal protector
Reagent: connects the reagent pipes
Diluent: connects the diluent pipes
Note: Only models BC-30s/31s/20s/21s
Liquid Detect
009-004360-00 are equipped with the 009-004360-00
Board Wire
Liquid Detect Board Wire, other models
(BC-10/11/10e/20/21/30/31/30e) are not
J14 equipped with this wire.
Float and The white connector connects the
009-004361-00 Aspirate Key aspirate key
Wire J15 The black connector connects the float
Connects 115-002795-00 TR60-H
009-004362-00 Recorder wire
J16 recorder
Indicate board Connects 051-001857-00 3008 indicator
009-004363-00
wire J19 board PCBA
009-004367-00 TempSensor J27 HEAT-TEMP: detects preheater

D-1
Cables and Wires

Wire temperature detection


DIL-TEMP: detects diluent temperature
Ground Wire for Connects the power assembly and the
009-004371-00
Safety middle power shutter
Cable of waste Weld to the BNC
3101-20-68592
pump
009-004369-00 RBC signal wire J29 Connects the RBC bath
009-004370-00 WBC signal wire J30 Connects the WBC bath
Connects the motor of the sampling
Module Ground
009-004372-00 assembly and the motor of the syringe
Wire
/ assembly
009-004368-00 HGB signal wire J28 Connects the HGB amp
009-007651-00 LCD‘s wire J24/J25 Connects the 8.4 inch LCD
Small touch Connects the 8.4 inch touch panel
009-004655-00
panel wire J26
LCD connection Connects the 10.4 inch LCD
009-007650-00
wire J24/J25
Touch panel Connects the 10.4 inch touch panel
009-004366-00
connection wire J26

D-2
E. Menu Tree
Access Level
Level 1 Level 2 Level 3
Operator Administrator Service
Sample
/ / √ √ √
Analysis
Table Review / / √ √ √
Setup √ √ √
L-J QC
Count √ √ √
QC
Setup √ √ √
X-B QC
Graph √ √ √
Manual / × √ √
Calibration Calibrator / × √ √
Fresh blood / × √ √
Background / × √ √
Reproducibilit
Performance / × × √
y
Carryover / × × √
Date/Time Setup √ √ √
Print setup √ √ √
Communication √ √ √
System Setup
Shortcut Code
× √ √
Setup
Lab Info Setup × √ √
Access
/ × √ √
Management
Auxiliary
Setup / √ √ √
Setup
Reference Unit
× √ √
Setting Setup
Parameters Reference Range
× √ √
Setup
Maintenance / √ √ √
Reagent
/ √ √ √
Setup
Gain Setup / × √ √
Maintenance / √ √ √
Self-Test / √ √ √
Sample Probe
/ × √ √
Debug
Gain
/ × √ √
Service Calibration
Temperature
/ × √ √
calibration
Screen Cal. / √ √ √
Advanced
/ × √ √
Toolbox

E-1
Menu Tree

Log / √ √ √
Counter / √ √ √
Temp &
/ √ √ √
Pressure
Status Voltage / × √ √
Sensor / × √ √
View √ √ √
Version Info
Upgrade × √ √
Logout / / √ √ √
Shutdown / / √ √ √
"√" indicates that this menu item is available at the access level; "×" indicates that this menu
item is not available at the access level.

E-2
F. Appendix Table
Product Model SN
Inspection
No. Description Requirement Result Conclusion
Item
See the
Electrical Safe and reliable
1 diagrams in the □OK □NG □PASS □FAIL
connections earthing
appendices
Beeping Having beeping
2 / □OK □NG □PASS □FAIL
alarm alarm
Correct time and
3 Time and date Time and date □OK □NG □PASS □FAIL
date
Version and
4 Version configuration Correct version □OK □NG □PASS □FAIL
information
See the section
Mechanical Sample probe
of "Adjusting
5 position position in relation □OK □NG □PASS □FAIL
Mechanical
validation to the WBC bath
Positions"
See the section
Mechanical Sample probe
of "Adjusting
6 position position in relation □OK □NG □PASS □FAIL
Mechanical
validation to the RBC bath
Positions"
Whether there is
bubble in the No bubble □OK □NG □PASS □FAIL
aspiration tubing
Whether there is
liquid suspended at No suspended
□OK □NG □PASS □FAIL
the sample probe liquid
tip
Sample probe is
under the surface of Sample probe
the liquid and does lower position □OK □NG □PASS □FAIL
not contact the normal
Counting bottom of the bath
7
Channel Test Whether there are
There are
bubbles when
bubbles when □OK □NG □PASS □FAIL
making bubbles in
making bubbles
the WBC bath
Whether there are
There are
bubbles when
bubbles when □OK □NG □PASS □FAIL
making bubbles in
making bubbles
the RBC bath
In the process of
making bubbles in No overflow or
□OK □NG □PASS □FAIL
the WBC bath, contact
whether there is

F-1
Appendix Table

overflow, and
whether the
bubbles contact the
inlet tube
In the process of
making bubbles in
the RBC bath,
whether there is No overflow or
□OK □NG □PASS □FAIL
overflow, and contact
whether the
bubbles contact the
inlet tube
Whether the WBC
Emptied
bath is emptied □OK □NG □PASS □FAIL
normally
normally
Whether the RBC
Emptied
bath is emptied □OK □NG □PASS □FAIL
normally
normally
Bath shielding box Screws are well
□OK □NG □PASS □FAIL
installation fixed
No interference
Sample probe
when the sample □OK □NG □PASS □FAIL
action
probe is in action
No interference
between the
Sample probe
sample probe □OK □NG □PASS □FAIL
tubing
tubing and other
structures
Perform Refer to the
Instrument
8 maintenance and operator's □OK □NG □PASS □FAIL
maintenance
cleaning manual
WBC ≤0.20×109/L □PASS □FAIL
RBC ≤0.02×1012/L □PASS □FAIL
Background
9 HGB ≤1g/L □PASS □FAIL
test
HCT ≤0.50% □PASS □FAIL
PLT ≤5×109/L □PASS □FAIL
Print analysis Able to print
10 Recorder □OK □NG □PASS □FAIL
results properly
No error
11 Shutdown Shutdown process message or □OK □NG □PASS □FAIL
alarm

Tested by: Date:

F-2
P/N: 046-011449-00(7.0)

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