IVD Global Technical Support Dept.
New 3-DIFF
(AUTO) HEMATOLOGY ANALYZER
SERVICE MANUAL
Volume I
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Table of Contents
Volume I
1 Using This Manual ...................................................................................1-1
1.1
Overview ................................................................................................................ 1-1
1.2
Who Should Read This Manual ............................................................................. 1-1
1.3
Using This Manual ................................................................................................. 1-1
1.4
Conventions Used in This Manual ......................................................................... 1-2
2 Product Specifications ............................................................................2-3
2.1
Product Name ........................................................................................................ 2-3
2.1.1
Physical Specifications ............................................................................. 2-3
2.1.2
Electrical Specifications ............................................................................ 2-4
2.1.3
Environment Requirements ...................................................................... 2-5
2.1.4
Product Specifications .............................................................................. 2-5
2.2
Testing Parameters ................................................................................................ 2-6
2.3
Performance Requirements................................................................................... 2-7
2.4
2.5
2.6
2.7
2.3.1
Background/Blank Count ......................................................................... 2-7
2.3.2
Carryover .................................................................................................. 2-7
2.3.3
Repeatability............................................................................................. 2-8
2.3.4
Linearity .................................................................................................. 2-10
Product Description ............................................................................................. 2-11
2.4.1
Main unit ................................................................................................. 2-14
2.4.2
Power/status indicator ............................................................................ 2-14
2.4.3
Power input connector ........................................................................... 2-14
2.4.4
[Aspiration] Key ...................................................................................... 2-14
2.4.5
USB ports ............................................................................................... 2-14
Product Configuration .......................................................................................... 2-14
Reagents, Controls and Calibrators .................................................................... 2-14
2.6.1
Reagents ................................................................................................ 2-15
2.6.2
Controls and Calibrators ........................................................................ 2-16
Information Storage Capacity .............................................................................. 2-16
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
3.5.3
3.6
HGB Measurement................................................................................... 3-5
RBC/PLT Measurement ......................................................................................... 3-6
3.6.1
Impedance Method................................................................................... 3-6
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.
4.2
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
Review ................................................................................................................... 4-2
4.2.1
4.3
Trend Graph ............................................................................................. 4-2
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
4.8
4.9
4.7.1
Background Count.................................................................................. 4-12
4.7.2
Reproducibility ........................................................................................ 4-13
4.7.3
Carryover ................................................................................................ 4-14
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
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.................................................................................................................. 4-19
5 Data Transmission ...................................................................................5-1
5.1
5.2
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
Setup of Data Management Software ................................................................... 5-5
5.2.1
Communication Parameter Setup ............................................................ 5-5
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
5.2.2
5.3
Communication Instrument Management ................................................ 5-6
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 ........................................................................................ 6-4
6.1.5
Vacuum pump .......................................................................................... 6-5
6.1.6
Air pump ................................................................................................... 6-5
6.1.7
Sample probe ........................................................................................... 6-6
6.1.8
Probe wipes .............................................................................................. 6-7
6.1.9
Baths ........................................................................................................ 6-7
6.1.10
6.2
6.3
Filters ................................................................................................ 6-8
Sample Dilution Flow Chart ................................................................................... 6-9
6.2.1
Whole Blood Mode (for Dual-Bath Analyzers) ....................................... 6-10
6.2.2
Whole Blood Mode (for Single-Bath Analyzers Except BC-10e) ........... 6-11
6.2.3
Predilute Mode (for Dual-Bath Analyzers) .............................................. 6-13
6.2.4
Predilute Mode (for Single-Bath Analyzers) ........................................... 6-14
6.2.5
Whole Blood Mode (for Single-Bath BC-10e Only) ................................ 6-16
Introduction to Fluidic Channels .......................................................................... 6-17
6.3.1
Fluidic Channels for Dual-Channel Analyzers ........................................ 6-18
6.3.2
Fluidic Channels for Single-Channel Analyzers Except BC-10e ............ 6-20
6.3.3
Fluidic Channels for Single-Bath BC-10e .............................................. 6-21
6.4
Sample Volume ................................................................................................... 6-22
6.5
Temperature of Fluidics ....................................................................................... 6-22
6.6
6.5.1
Introduction to the Thermo System ........................................................ 6-22
6.5.2
Diluent Heating System .......................................................................... 6-23
Introduction to Sequences ................................................................................... 6-24
6.6.1
Analysis Sequence under Whole Blood Mode ....................................... 6-24
6.6.2
Analysis Sequence under Predilute Mode ............................................. 6-31
6.6.3
Introduction to Major Maintenance Sequences ...................................... 6-31
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
7.4
7.3.1
Overview .................................................................................................. 7-3
7.3.2
Components ............................................................................................. 7-3
7.3.3
Debugging and Troubleshooting .............................................................. 7-7
Power Assembly .................................................................................................. 7-10
7.4.1
Overview ................................................................................................ 7-10
7.4.2
Overview of the Original Power Assembly ............................................. 7-10
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
7.5
7.6
7.7
7.4.3
Power Board Replacing and Wiring for the Original Power Assembly ... 7-12
7.4.4
Overview of the New Power Assembly .................................................. 7-13
7.4.5
Power Board Replacing and Wiring for the New Power Assembly ........ 7-14
Touch Screen Control Board ............................................................................... 7-15
7.5.1
Introduction ............................................................................................. 7-15
7.5.2
Components ........................................................................................... 7-15
Indicator Board .................................................................................................... 7-15
7.6.1
Introduction ............................................................................................. 7-15
7.6.2
Components ........................................................................................... 7-16
Motors, Photocouplers and Micro-switches ......................................................... 7-16
7.7.1
7.8
7.9
Introduction ............................................................................................. 7-16
Liquid Detection Board ........................................................................................ 7-16
7.8.1
Introduction ............................................................................................. 7-16
7.8.2
Components ........................................................................................... 7-17
Hardware Troubleshooting .................................................................................. 7-17
7.9.1
System Error .......................................................................................... 7-17
7.9.2
Troubleshooting for Main Control Board ................................................ 7-19
7.9.3
Power Board Errors ................................................................................ 7-23
7.9.4
Touch Screen Control Board Errors ....................................................... 7-23
7.9.5
Indicator Board Errors ............................................................................ 7-25
7.9.6
Motor and Photocoupler Errors .............................................................. 7-26
7.9.7
Liquid detection board error ................................................................... 7-26
8 Mechanical System ..................................................................................8-1
8.1
8.2
8.3
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
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
Disassembly and Installation ............................................................................... 8-19
8.3.1
Tools ....................................................................................................... 8-19
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
8.3.2
8.4
Before Disassembly ............................................................................... 8-20
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
8-33
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 .................................................................... 8-47
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
Volume II
14 Analyzer Installation ................................................................................. 5
14.1 Preparations ............................................................................................................. 5
14.1.1
Tools .................................................................................................... 5
14.1.2
Consumables ....................................................................................... 5
14.2 Installation Requirements ......................................................................................... 5
14.2.1
Environment Requirements ................................................................. 5
14.2.2
Space Requirements ........................................................................... 6
14.2.3
Power Supply Requirements ............................................................... 6
14.2.4
Confirming the Tube Type on Site ....................................................... 6
14.3 Unpacking ................................................................................................................. 6
14.3.1
Checking before Unpacking ................................................................ 6
14.3.2
Unpacking the Main Unit ..................................................................... 7
14.3.3
Checking Packing List ......................................................................... 9
14.4 Connections ............................................................................................................ 10
14.5 Startup and Setup ................................................................................................... 13
14.5.1
Initial Start-up ..................................................................................... 13
14.5.2
Reagent Setup ................................................................................... 14
14.5.3
Maintenance Setup ............................................................................ 15
14.5.4
Other Function Verification ................................................................ 17
14.5.5
Verification of External Barcode Scanning ........................................ 17
14.6 Performance Test ................................................................................................... 18
14.6.1
Background Verification ..................................................................... 18
14.6.2
Repeatability Test .............................................................................. 20
14.6.3
Accuracy Verification ...................................................................... 14-1
15 Setup of Data Transmission and LIS Connection .............................15-1
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
15.1 LIS Connection .................................................................................................... 15-1
15.1.1
Network Communication ................................................................ 15-1
15.1.2
Serial Interface Communication ..................................................... 15-3
15.1.3
Transmission Mode ........................................................................ 15-4
15.2 Setup of Data Management Software ................................................................. 15-5
15.2.1
Communication Parameter Setup .................................................. 15-5
15.2.2
Communication Instrument Management ...................................... 15-6
15.3 Troubleshooting for Communication Errors ......................................................... 15-6
15.4 LIS Connection Configuration ............................................................................. 15-6
15.4.1
Network Setup ................................................................................ 15-7
15.4.2
Communication Parameter Setup .................................................. 15-8
15.4.3
Common LIS Errors ...................................................................... 15-12
15.4.4
User Guide to Bidirectional Test Tool ............................................ 15-15
15.4.5
User Guide to Data Parsing Tool .................................................. 15-17
16 Disassembly and Installation ..............................................................16-1
16.1 Tools .................................................................................................................... 16-1
16.2 Before disassembly ............................................................................................. 16-1
16.3 Removing the Main Unit ...................................................................................... 16-2
16.3.1
Remove the Left Door Assembly .................................................... 16-2
16.3.2
Remove the Main Control Board .................................................... 16-2
16.3.3
Remove the right door .................................................................... 16-4
16.3.4
Remove the RBC Bath Assembly ................................................... 16-4
16.3.5
Remove the WBC bath and HGB Light Assembly.......................... 16-5
16.3.6
Remove the Preheating Assembly ................................................. 16-6
16.3.7
Remove the Right Side Valve Assembly ........................................ 16-7
16.3.8
Remove the Liquid Detection Board PCBA .................................... 16-7
16.3.9
Remove the Waste Pump ............................................................... 16-8
16.3.10
Remove the Air Pump ..................................................................... 16-9
16.3.11
Remove the Vacuum Chamber Assembly ...................................... 16-9
16.3.12
Remove the Diluent Temperature Sensor .................................... 16-10
16.3.13
Remove the Top Cover ................................................................. 16-10
16.3.14
Remove the Aspiration Module ..................................................... 16-11
16.3.15
Remove the Motor Horizontal Photocoupler Assembly of Aspiration
Module
16-12
16.3.16
Replace the Sample Probe ........................................................... 16-12
16.3.17
Remove the Probe Wipe .............................................................. 16-13
16.3.18
Remove the Aspiration Module Photocoupler in Vertical Direction16-14
16.3.19
Remove the Front Cover Assembly .............................................. 16-15
16.3.20
Remove the Indicator PCBA......................................................... 16-15
16.3.21
Remove the Touch Screen Control Board .................................... 16-16
16.3.22
Remove the Touch Screen Assembly ........................................... 16-16
16.3.23
Remove the Touch Screen ........................................................... 16-17
16.3.24
Remove the Micro-switch Assembly ............................................. 16-18
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
16.3.25
Remove the Syringe ..................................................................... 16-19
16.3.26
Remove the Syringe Motor ........................................................... 16-19
16.3.27
Remove the Syringe Motor Position Photocoupler Assembly ...... 16-20
16.3.28
Replace the RBC/WBC Isolation Chamber Filter ......................... 16-21
16.3.29
Replace the Power Unit ................................................................ 16-21
16.3.30
Remove the Recorder .................................................................. 16-22
17 Assembly Exploded Views ..................................................................17-1
17.1 Overview .............................................................................................................. 17-1
17.2 Instrument Panels ................................................................................................ 17-1
17.3 Front Side ............................................................................................................ 17-3
17.3.1
8.4” LCD Front Panel Assembly (for BC-10&10e&11&20s&21s) ... 17-3
17.3.2
10.4” LCD Front Panel Assembly (for BC-20&21&30&31&30s&31s)17-3
17.3.3
Front Panel Assembly Back View ................................................... 17-5
17.3.4
Components on The Front Frame .................................................. 17-6
17.4 Right Side ............................................................................................................ 17-9
17.4.1
Sampling Assembly Position .......................................................... 17-9
17.4.2
Valves and Temperature Sensor .................................................. 17-12
17.4.3
Counting Bath (For BC-20s&21s&30&31&30s&31s) ................... 17-13
17.4.4
Counting Bath (for BC-10&10e&11&20&21)................................. 17-14
17.4.5
WBC Counting Bath Assembly ..................................................... 17-15
17.4.6
RBC Counting Bath ...................................................................... 17-16
17.4.7
Pump ............................................................................................ 17-17
17.4.8
Vacuum Chamber and Preheat Assembly .................................... 17-18
17.4.9
Reagent Detector Assembly Position (For BC-20s&21s&30s&31s)17-19
17.4.10
Reagent Detector Assembly (For BC-20s&21s&30s&31s) .......... 17-20
17.5 Left Side Frame ................................................................................................. 17-20
17.6 Back Panel and Left Side Panel ........................................................................ 17-21
17.6.1
Power Box Assembly .................................................................... 17-22
18 Error Messages and Troubleshooting ..............................................18-23
18.1 Troubleshooting ................................................................................................. 18-23
18.2 Troubleshooting Flowchart ................................................................................ 18-32
18.2.1
HGB Blank Voltage Abnormal ....................................................... 18-32
18.2.2
Background Abnormal .................................................................. 18-33
18.2.3
Motor Error of Lift Mechanism of Sample Assembly .................... 18-33
18.2.4
Power Error ................................................................................... 18-34
18.2.5
Clogging ........................................................................................ 18-34
18.2.6
Vac Pressure Error ....................................................................... 18-35
19 Service-Related Engineering Change Traceability Table ..................19-1
20 Alignment .............................................................................................20-1
20.1 Align the Mechanical Position ............................................................................. 20-1
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
20.2 Align the Detection Components ......................................................................... 20-4
20.2.1
Detect the Counting Lane ............................................................... 20-4
20.3 Save Settings ...................................................................................................... 20-6
20.4 Verify Service Alignment ...................................................................................... 20-1
21 Maintenance BOM ................................................................................21-1
Appendix A ...................................................................................... Fluidics Diagram F-1
Appendix B ...................................................... Comparison Table of Connectors F-1
Appendix C ...................................................................... Hardware Block Diagram F-1
Appendix D ..................................................................................... Cables and Wires F-1
Appendix E .............................................................Alignment Confirmation Table 3
Appendix F ............................................................................... Installation Checklist 4
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
1Using This Manual
1.1 Overview
This chapter describes how to use the service manual. In this manual, the repair methods of
the BC-6000 series analyzers are described in detail. Before servicing the BC-6000 series
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 BC-6000 series Operator’s manual. It does
not contain information and procedures already covered in the Operator’s manual of the
BC-6000 series analyzers.
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
ranges and test principle
No.: HXQ-19001-New 3-DIFF
Version: 1.0
System Principles
IVD Global Technical Support Dept.
learn about interface introduction and upgrading of
Chapter
BC-20s/BC-30
Interface
learn about the 3-DIFF analyzers’ external interface
Chapter 5
4
Software
and
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;
composition,
adjusting,
testing
points
Chapter 7 Hardware System
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
troubleshooting
Debug after the 3-DIFF analyzers being serviced
Chapter 10 Adjustment
Debugging and verification after the 3-DIFF analyzers
Chapter
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
11
Debugging
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
2Product 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
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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
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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℃
20%～85%
10%～90%
10%～90%
70kPa～106kPa Note1
50kPa～106kPa
70kPa～106kPa
Temperature
Relative
Humidity
Atmospheric
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
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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
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
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Platelet Cell Histogram
PLT Histogram
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.
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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,
BC-11, BC-20, BC-21, BC-30, BC-31, and BC-30e)
HGB
≤1.0％(applicable to BC-10e)
≤1.0%
PLT
Table 2-8 Sample Concentration Range of Carryover Test
High Concentration
Parameter
Unit
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
Range
Low Concentration Range
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
Repeatability
Repeatability
(4.00 ~ 15.00) 109 / L
≤ 4.0%
≤ 4.0%
(3.50 ~ 6.50)  1012 / L
≤ 2.5％
≤ 2.5％
Parameter
Condition
WBC
RBC
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HGB
(100 ~ 180) g/L
≤ 2.0％
≤ 2.0％
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
Parameter
Blood
Repeatability
Condition
(CV/absolute
deviation
d)
WBC
(7.00～15.00)  109 /L
(4.00 ~ 6.90)
109 /
L
(3.50 ~ 6.50)  1012 / L
RBC
≤2.0％
(CV/absolute deviation
d)
≤4.0％
≤3.5％
≤1.5%
Predilute Repeatability
(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)
≤2.0 ％ (applicable
BC-20.
BC-21,
to
BC-10,
and BC-11)
≤ 2.5％
(applicable
BC-21,
to
BC-20,
BC-10,
and
BC-11)
HGB
100 ~ 180 g/L
≤1.5%
70.00～110.00 fL
≤0.5%
≤2.0%
(applicable
to
≤1.5%
BC-20s, BC-21s, BC-30s,
BC-31s, BC-30, BC-31,
and BC-30e)
MCV
≤1.0%
(applicable
BC-20,
BC-21,
to
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)
PLT
≤10.0％
(applicable
BC-21,
BC-11)
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BC-10,
BC-20,
and
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(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)
≤5.0%
(applicable
BC-20,
BC-21,
to
BC-10,
≤10.0％
(applicable
BC-21,
and BC-11)
to
BC-20,
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
Parameter
Deviation Range
Deviation Range
(Whole Blood)
(Predilute)
Linearity range
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％
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～
(100.10
±9％
±18%
300.00)×109/L
(applicable to BC-30s,
BC-31s,
BC-30,
BC-31, and BC-30e)
(0.0～8.00)×1012/L
RBC
±0.05×1012/L
or
±0.05×1012/L or ±5％
±5％
HGB
0～280g/L
±2g/L or ±2％
PLT
(0～1000)×109/L
±10×109/L
±2g/L or ±3％
or
±10×109/L or ±10%
±10%
(1001 ~ 4000)×109/L
±12%
±20%
±4% (HCT value)
/
(applicable to BC-30s,
BC-31s,
BC-30,
BC-31, and BC-30e)
HCT
0~67%
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.
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Figure 2-1 Front of the analyzer
1 ---- Display screen
2 ---- Power/status indicator
3 ---- Probe wipe block
4 ---- Sample probe
5 ---- [Aspirate] Key
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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
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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, and EPSON LQ-310.
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
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Mindray-specified reagents, which are formulated specifically for the fluidic system of your
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
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differential and HGB determination.
◼
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
BC-31s
50
should at least include the
BC-30
40
following:
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
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information
stored
(histogram),
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BC-10
5
BC-11
5
BC-10e
3
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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
RBC
diluenting
Aspirate/
Dispense
HGB
Measurement
Sample
Detected
HGB
Reaction
Scheduling Control
and Information
Processing
Human Machine
Interface
open-vial
Data
Management
RBC
Measurement
Signal
Processing
Sample
WBC
Reaction
Parameter
Analysis
WBC
Measurement
Power
Supply
Sample
Preparation
Status
Detection
Clean
Waste
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
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completing of sample measurement, the ultimate task of the analyzer.
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
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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 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:
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In the formula, WBC′ is corrected WBC count result; WBC is the WBC count provided by the
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.
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◼
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
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 Photocurrent 
HGB(g/L) = Constant  Ln 

 Sample Photocurrent 
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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
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
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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.
◼
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,
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the RBCs mostly fall in the region of 70~120fl.
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).
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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.
3.7 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
Possible
presence
Conditions
of
platelet coagulation, large
platelets, nucleated red
blood cells (NRBC), red
WBC Histogram
cells which are not broken
R1
down, protein with large
molecular weight and lipid
Abnormal cell size distribution of
WBC histogram in the left of the
LYM region
particulars. It may also
suggest electrical noise
WBC
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
numbers of eosinophils
and the mid-sized cell region.
and basophiles.
WBC Histogram
No.: HXQ-19001-New 3-DIFF
Possible
presence
of
Abnormal cell size distribution of
Version: 1.0
IVD Global Technical Support Dept.
R3
immature cells and blasts;
WBC histogram in the region
or eosinophilia.
between
the
mid-sized
cell
region and the granulocyte peak.
Possible
WBC Histogram
R4
large
presence
immature
of
cells,
Abnormal cell size distribution of
blasts, WBC agglutination
WBC histogram in the right of the
or high absolute number
granulocyte peak.
of granulocyte.
WBC Histogram
Rm
More than one abnormal
cell size distribution type
exists.
At least 2 WBC histogram R
flags are reported.
Abnormal WBC
WBC histogram R flag is
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
High
mid-sized
cell number
mid-sized
cell
number
Pancytopenia
Low WBC, RBC and PLT
count
Abnormal WBC histogram
MID# > 1.80×10^9/L
WBC < 4.0×10^9/L and RBC <
3.5×10^9/L
and
PLT
<
100×10^9/L
Possible
presence
of
microcytosis,
Abnormal
RBC
size distribution
macrocytosis,
anisocytosis,
RBC
agglutination
and
Abnormal RBC histogram
diamorphologic
histogram.
HGB
RBC
results
may
be
HGB
abnormal or interference
Abn./Interfere?
may exist (for example,
high WBC count)
PLT
MCHC > 380 g/L
or interfering parameters of HGB
exceed allowable ranges
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
High
Histogram
Ps
PLT
number
of
small
of
large
platelets.
Histogram
P1
No.: HXQ-19001-New 3-DIFF
High
number
platelets.
PLCR < 15%
PLCR > 50%
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Possible
PLT
Histogram
Pm
presence
of
microcytosis, RBC debris,
large platelet and platelet
coagulation.
Platelet
distribution
Abnormal PLT histogram
abnormal
The boundary of the PLT/RBC is
too confusing for the system to
define.
PLT
histogram
Pm
flag
is
reported
Thrombopenia
Low PLT count
PLT < 60×10^9/L
Thrombocytosis
High PLT count
PLT > 600×10^9/L
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
size distribution
LYM%, MID%, LYM#, and MID# are marked with flag R;
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
GRAN% and GRAN# are marked with flag R.
WBC
Leucopenia
None.
Leucocytosis
None.
Granulopenia
None.
Granulocytosis
None.
lymphopenia
None.
Lymphocytosis
None.
High mid-sized cell
None.
number
Pancytopenia
Abnormal RBC size
distribution
RBC
None.
When this message is reported, parameters RBC, HCT,
MCV, MCH, MCHC, RDWCV, and RDWSD are marked
with flag R.
HGB
When this message is reported, parameters HGB, MCH,
Abn./Interfere?
and MCHC are marked with flag R.
Microcytosis
None.
Macrocytosis
None.
Anemia
None.
Erythrocytosis
None.
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Platelet
distribution
PLT
abnormal
size
When this message is reported, parameters PLT, MPV,
PDW, PCT, PLCR and PLCC are marked with flag R.
Thrombopenia
None.
Thrombocytosis
None.
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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
IVD Global Technical Support Dept.
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 Review
4.2.1 Trend Graph
Operators can browse, validate, search, edit, and export data in the Table Review tab page.
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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):
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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".
Calibration with fresh blood can be performed under two modes: "WB" and "PD", which use
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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%].
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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.
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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.
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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.
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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.
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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)
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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.
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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.
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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.
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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:
Carryover (%) =
First low - level sample result－Third low - level sample result
 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).
No.: HXQ-19001-New 3-DIFF
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Figure 4-15 Advanced toolbox-System Configuration
Figure 4-16 Advanced toolbox-Other Settings
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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.
No.: HXQ-19001-New 3-DIFF
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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
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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
No.: HXQ-19001-New 3-DIFF
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If the update fails, try again.
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
4.11 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
Startup process completed
a short beep
Remarks
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,
carryover,
action,
or
sound.
reproducibility,
background,
aging
gain
calibration), press the [Aspiration]
key when it is not convenient to start
analysis
No.: HXQ-19001-New 3-DIFF
Version: 1.0
the
buzzer
may not
IVD Global Technical Support Dept.
Error
Long
Analyzer ready
beeps
at
Tap the "Remove error" button to
intervals
silent the buzzer
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.
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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
on the right of the
5-1
button
pull down list, the following dialog box is displayed.
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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.
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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;
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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
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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.
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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.
No.: HXQ-19001-New 3-DIFF
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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 N.O.(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
electromagnet 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
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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.
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Table 6-1 Syringe specifications and functions
Name
Low volume
syringe
Specification
Function
Aspirate and dispense blood sample of precise volume,
Full range 250ul
and perform second aspiration
Dispense fixed volume of diluent to the WBC and RBC
High volume
syringe
bathes, dispense liquid to the probe wipes, and supports
Full range: 10ml
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.
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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:
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◼
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.
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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
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RBC/PLT.
◼
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.
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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
See 6.2.1 Whole Blood Mode (for
See 6.2.3 Predilute Mode (for
Dual-Bath Analyzers).
Dual-Bath Analyzers).
See 6.2.2 Whole Blood Mode (for
See 6.2.4 Predilute Mode (for
series single-bath
Single-Bath
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
hematology
mode.
Flow Chart for
New
series
3-DIFF
dual-bath
auto hematology
analyzers
(BC-30/31/30e/20
s/21s/30s/31s)
New
3-DIFF
Analyzers
analyzers
Except
in
WB
analyzers
in
PD
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
No.: HXQ-19001-New 3-DIFF
The sample dilution flow chart of
Version: 1.0
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series single-bath
Single-Bath BC-10e Only).
new 3-DIFF series single-bath
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
auto hematology analyzers in PD
mode.
mode.
See 6.2.4 Predilute Mode (for
The differences lie in the sample
Single-Bath Analyzers).
analyzers
in
PD
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.
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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:
1:173.22
Aspirate 23.1ul diluted sample
Lyse 310ul
WBC sample
Dilution ratio 1:305.2
Diluent 2.2ml
RBC sample
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
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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:
A spira te 9ul
sam p le
D iluen t
1.55m l
D ilution ra tio:
1:17 3.22
A spira te 23.1ul dilu te d sam ple
First measure
WBC/HGB
Lyse 31 0ul
W B C sa m ple
D ilution ra tio 1:30 5.2
No.: HXQ-19001-New 3-DIFF
Then measure
RBC/PLT
D iluen t 2.2m l
R B C sa m ple
D ilution ra tio 1:16 49 7.3
Version: 1.0
IVD Global Technical Support Dept.
Figure 6-2 Dilution under whole blood mode (for single-bath analyzers)
20ul of whole
blood sample
700ul of diluent
1:36 dilution
198ul
1352ul of
diluent
37.7ul
1:281.82
dilution
2.2ml of diluent
310ul of lyse
1:500.8 dilution for
WBC measurement
1:16445.7 dilution for
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.
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5.
The analyzer adds lyse to the WBC bath and mixes for reaction;
6.
The analyzer runs the analysis;
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
Diluent 700ul
Configure the
dilution
manually
Dilution ratio:
1:36
Aspirate
198ul
sample
Diluent
1352ul
Dilution ratio
1:281.82
Lyse 310ul
WBC sample
Dilution ratio 1:500.8
Aspirate 37.7ul diluted sample
Diluent 2.2ml
RBC sample
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
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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.
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:
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C apilla ry b loo d
sam p le 20 ul
D iluen t 70 0ul
Configure the
dilution
manually
D ilution ra tio:
1:36
A spira te
19 8ul
sam p le
D iluen t
13 52ul
D ilution ra tio
1:28 1.82
A spira te 37.7ul dilu te d sam ple
First measure
WBC/HGB
Lyse 31 0ul
Then measure
RBC/PLT
D iluen t 2.2m l
R B C sa m ple
D ilution ra tio 1:16 44 5.7
W B C sa m ple
D ilution ra tio 1:50 0.8
Figure 6-5 Dilution under predilute mode (for single-bath analyzers)
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;
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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:
20ul of whole
blood sample
700ul of diluent
1:36 dilution
198ul
1352ul of
diluent
37.7ul
1:281.82
dilution
2.2ml of diluent
310ul of lyse
1:500.8 dilution for
WBC measurement
1:16445.7 dilution for
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.
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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
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
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◼
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.
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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
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◼
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
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◼
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
≤ 9μL
≤ 20μL
≤ 9μL
≤ 20μL
≤ 9μL
≤ 20μL
3-DIFF series single-bath auto
hematology analyzers
(BC-10/11/20/21)
3-DIFF series dual-bath auto
hematology analyzers
(BC-30/31/30e/20s/21s/30s/31s)
3-DIFF series single-bath
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:
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Name
Temperature range (°C)
Diluent detection unit temperature
Preheating unit temperature
5-45
Floating value, determined by diluent temperature.
[Target temperature] -2, Target temperature +3]
6.5.2 Diluent Heating System
Diluent Temperature
Detection Unit
Reaction Bath
Temperature
Detection Unit
J27
Main Control
Board
PIN3
J11
Temperature
Switch
Preheating
Assembly
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.
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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.
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②
③
①
WBC
Diluent
a)
b)
②
②
③
RBC
Diluent
base
Sample
①
③
①
WBC
RBC
WBC
c)
d)
First
dilution
②
③
RBC
①
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
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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.
②
③
①
WBC
Diluent
b)
a)
①
②
②
①
RBC
count
WBC
count
First
dilution
c)
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d)
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Figure 6-8 Sampling and dispensing process (for single-bath analyzers except BC-10e)
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.
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①
①
①
Sample
a)
centrifugal
tube
Sample
b)
①
①
①
WBC
Diluent
c)
①
centrifugal
tube
①
①
①
RBC
coun
t
WBC
count
First
dilution
d)
e)
Secon
d
dilution
Figure 6-9 Sampling and dispensing process (for single-bath analyzer BC-10e
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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
T23
in the direction indicated by the red arrows.
RBC
T35
C6
J3-T34-J4
T25
J1-T33-J2
T24
WBC
C7
T36
Isolation Chamber 1
Isolation Chamber 2
T26
SV04
T27
C8
T28
T55
T29
C24
C21
T53
VC
Transducer
Figure 6-10 Analysis Procedure (for dual-bath analyzers)
For single-bath analyzers:
After the sample aspiration and dispensing procedure, the analysis will start. See Figure 6-11
for the procedure.
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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
C12
WBC
T22
T25
T24
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;
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;
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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.
6.6.3.3
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,
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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.
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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.
Colorimetry channel
Impedance channel
RBC bath
Signal
preconditioning
Signal collection
Digital processing
Embedded
platform of the
main control
Monitored signal
Universal
USB interface
external interface Network interface
Data flow
WBC
bath
Structure and
interconnection
User input and
output
LCD screen
Touch screen
Aspirate key
Recorder
Large memory
Syringe
assembly
Motor driving
Sensor detection
Liquid detection
assembly
Liquid detection
Vacuum building
detection
Motor driving
Sensor detection
Diluent
temperature
Reaction bath
temperature
control
Power driving
Aspiration
module
User interaction
Power switch
Net power
switching &
preconditioning
Control flow
Net power
Power supply subsystem
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
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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
membrane
Temperature
sensor
Waste
floater
Temperature control
Preheating bath
Vacuum
pump
HGB
assembly
Aperture
HGB control
and signal
PD
LED
WBC bath assembly
Aperture
Stepping
motor
Aperture driving
and impedance signal
RBC bath
Wired network
interfaceX1
Sensor
Syringe assembly
USB interfaceX4
Sensor X3
Stepping
motor X2
Recorder
Aspiration module
Electromagnetic
valveX12
Aspirate key
Liquid detection
board
Indicator board
LCD screen data
P12V
P24V
D5V
A12V_P/N
Power
assembly
Backlight control
Touch
screen
data
D5V
P12V
Main control board
LCD screen
(touch
screen)
Touch screen
control board
Front cover assembly
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.
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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
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EEPRO
M
DDR2 SDRAM
Analog
circuit
AD
C
(RBC/WBC/HGB/monitor)
Driving
module
PHY
Ethernet interface
USBHUB
USB interface
CPU
FPGA
Touch screen
TFT screen
Indicator board
Recorder
(Motors/valves, pumps/heating)
JTAG, configuration
chip
Digital
power
Real-time
clock
SDCARD
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.
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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.
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Table 7-1 Functions of sockets on the main control board
Sockets
J4
Function
Socket
PIN function description
to
analog circuit
PIN1: 12V
Description
/
PIN2: 12V_N
PIN4: AC120V_A
PIN5: AC120V_B
PIN3,PIN6: GND
J5
Socket
to
digital circuit
J6
Socket
PIN1,2: 5V
/
PIN3,4: GND
to
power circuit
PIN1,2: 24V
Control motors, valves, pumps,
PIN3,4: 12V
heaters and LCD backlight
PIN5~8: GND
J7
Socket
to
/
/
to
/
/
Socket to valve
/
/
to
PIN1,3: 24V
/
to
/
/
sampling motor
J8
Socket
syringe motor
J9
and pump drive
J11
Socket
heaters
J12
Socket
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
[Aspirate]
and
to
key
waste
detection
PIN1:
[Aspirate]
key
/
signals
PIN3: floater signals
PIN2,4: GND
floater
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J16
Socket
to
/
/
to
/
/
Socket for LCD
/
/
/
/
/
/
printer interface
J19
Socket
keypad
interface
J24
signal
processing
J25
Socket for LCD
backlight
control
J26
Socket to touch
screen
pinboard
J27
Socket
J28
to
PIN1,3:
temperature
/
temperature
sensors
sensor
PIN2,4: GND
Socket to HGB
/
/
/
Used for dual-bath analyzers
assembly
J29
Socket for RBC
signal
only.
processing
J30
Socket
WBC
for
/
/
signal
processing
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
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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
7.3.3.2 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
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interrupt signal
2
TP4
Touch
screen
/
ground
/
reset signal
3
TP5
Digital
cable
4
TP7
Backlight enabling
Voltage is 3.3V; main control board error
signal
5
TP8
Backlight
PWM
signal
6
TP9
Voltage is out of the range of 0.7V~1.2V; main
control board error
Backlight
GND
/
signal
7
8
9
TP61
TP69
TP70
5V
voltage
Voltage is not 5V; main control board or power
monitoring point
board error
VDD 3.3V voltage
Voltage is not 3.3V; main control board or power
monitoring point
board error
VDD18
1.8
V
voltage
Voltage is not 1.8V; main control board or power
board error
monitoring point
10
TP71
VDD12
1.2
V
voltage
Voltage is not 1.2V; main control board or power
board error
monitoring point
11
TP80
VDD25
2.5
V
voltage
Voltage is not 2.5V; main control board or power
board error
monitoring point
12
TP84
Analog ground
/
13
TP87
12V
Voltage is not 12V; main control board or power
voltage
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
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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
7.4 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
Appearance of Power Unit
Original Power Assembly
One big square board
New Power Assembly
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:
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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.
D5V
Description
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
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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.
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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
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Red
5V
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
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screws.
⚫
Before disassemble a power board, ensure these power boards and their
peripherals have cooled off.
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.
Pinaster main
control board
I2C
Touch
screen
drive board
Touch screen
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.
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Figure 7-8 Indicator board
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.
7.8 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.
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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.
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Power supply abnormal
Y
Is the
AC power connection
reliable?
N
Unplug the power
cord and then
reconnect it
Y
Is the
filter connection
reliable?
Disconnect and
then reconnect the
plug
N
Y
Does the
fuse of the power
assembly work
properly?
Y
Is
the voltage
at the output pin
normal after the filter
switch is
closed?
N
N
Replace the fuse
Replace the AC
power cord. If the
voltage is still
abnormal, replace
the filter
Y
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.
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Protect right after
switching on the
power
Can you power on
after unplugging all the
cables at the power output
end?
N
Power assembly
error. Replace the
power assembly
Y
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 shortcircuit 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.
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Table 7-7 Troubleshooting for main control board
No.
1
Error
Troubleshooting
Solution
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
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
and
the
backlight
and
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
proceed to next step.
screen
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LCD
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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
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
and
the
backlight
and
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.
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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
analyzer is powered on, then the USB HUB chip
control board
to
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
peripherals
connecting
connected to the USB ports (mouse, keyboard or
USB ports.
powered
on,
replace
the
to
the
USB disk etc.). If the peripherals still cannot be
used, proceed to next step.
6
3. If the error still remains after all above steps,
Replace the main
replace the main control board.
control board
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
[Aspirate] key gets loose or broken. If yes,
no
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respond
reconnect the cable or replace it.
when
2. If the error remains after step 1, disassemble
the
[Aspirate]
the connecting board to the [Aspirate] key
key
switch, and see whether there is liquid split on
is
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
Is the AC input
voltage normal?
N
Check the
components
including the filter,
fuse
Y
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
control
board
properly (e.g. check whether the display screen
response
error/touch screen
displays normally, and whether the analyzer can
when
error/poor
be
connection
troubleshooting for the main control board first;
touched
not
being
operated
with
a
mouse.
If
not,
start
2. Check whether the connecting cable between
the touch screen drive board and the main control
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board get loose or broken. If yes, reconnect or
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
only moves in
connecting
horizontal
touch
or
cable
the
screen
vertical
control board and
direction.
the touch screen
1. Check whether is any crack on the touch screen.
If yes, replace the touch screen.
2. Reconnect the cable connecting the touch
screen control board and 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
touched position, so that you cannot even enter the
gets
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.
touchscreen
front
cover
touchscreen, Ensure that the foam is in the out ring
has
presses
the
of the touchscreen and is not pressing the
no
response
when
clicked.
cursor
it
touchscreen.
Remove
the
front
touchscreen.
is
The
stays
in one corner
and
cannot
move.
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reinstall
the
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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
analyzer
operations like sample analysis and information
the
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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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
stop
2
Photocoupler
won't
1. Check whether the problem is caused by main
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
Motor
rotates,
main control board error first;
but won't arrive
2.
at
photocoupler and the main control board get loose
the
Check
whether
the
cable
connecting
a
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.
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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
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Figure 8-2 Front of the analyzer (front cover open)
1 --- [Aspirate] key
2 --- [Start] key
3 --- Syringe
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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
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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
No.: HXQ-19001-New 3-DIFF
2 --- Reagent bottle
Version: 1.0
IVD Global Technical Support Dept.
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 --- Electromagnetic 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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
1
Main unit
/
/
2
Front cover assembly
/
/
3
Right door
/
/
4
Top cover
/
/
/
/
part ID
Remarks
Cross-recessed small panhead
5
screw combination GB/T9074.8
M3X8
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
ID
6
Material description
Cross-recessed sunk screw
GB/T819.1-2000 M3X6
Maintenance spare
part ID
Remarks
/
/
8.2.3 Main Unit
8.2.3.1
Explosive View
8.2.3.2
Bill of Materials
Maintenance
ID
Material description
1
Frame assembly
/
2
Start key assembly
115-025647-00
3
Start key
/
/
4
Key installation board
/
/
5
Syringe assembly
115-025639-00
/
No.: HXQ-19001-New 3-DIFF
spare part ID
Version: 1.0
Remarks
/
IVD Global Technical Support Dept.
Maintenance
ID
Material description
6
Insulation bar
/
/
7
Sampling assembly
115-025638-00
/
8
Shielding bottom plate welding piece
/
/
801-3201-00003-00
/
9
spare part ID
New 3-way micro-electromagnetic valve (short line,
new connector)
Remarks
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
/
801-3201-00002-00
/
115-015967-00
/
22
23
2-way micro-electromagnetic valve (short line, new
connector)
SMC 3-way fluidic valve assembly (3106)
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
ID
Material description
24
Reagent detection assembly
No.: HXQ-19001-New 3-DIFF
Maintenance
spare part ID
115-025642-00
Version: 1.0
Remarks
/
IVD Global Technical Support Dept.
Maintenance spare
ID
Material description
25
Power pack assembly
115-054722-00
/
26
Lower signal shielding cover
/
/
27
3008 main control board PCBA
051-001714-00
/
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
/
/
part ID
Remarks
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
8.2.4.1
Explosive View
8.2.4.2
Bill of Materials
ID
Material description
1
Nel assembled (BC-20S)
2
Maintenance
spare part ID
043-007675-00
Long weather strip for 8 in touch screen
047-005535-00
LONG GASKET, IPM8 TOUCH SREEN
Remarks
These 3
must be
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
1
Panel assembled (BC-30S)
043-005464-00
These 3
2
10INCH TOUCHSCREEN LONG GASKET
047-016362-00
must be
spare part ID
Remarks
replaced
3
10INCH TOUCHSCREEN SHORT GASKET
047-016363-00
at the
same
time
4
Touch screen 10.4'
801-3110-00184-00
/
5
LCD assembly (10.4")
115-025652-00
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
ID
Maintenance
Material description
spare part ID
Remarks
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
8.2.6 Syringe Assembly
8.2.6.1
Explosive View
8.2.6.2
Bill of Materials
Maintenance spare part
ID
Material description
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
/
/
/
6
Cross-recessed small panhead screw
combination M3X8
No.: HXQ-19001-New 3-DIFF
ID
Version: 1.0
Remarks
IVD Global Technical Support Dept.
Maintenance spare part
ID
Material description
7
Syringe fixing plate (1 to 2)
/
/
8
250ul syringe (with nozzle)
115-027479-00
/
9
Rotation Motor Position Sensor Assembly
801-3003-00015-00
/
10
Cross-recessed panhead screw M3X6
/
/
11
Inner hexagon socket cap screw M3X12
/
/
ID
Remarks
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
/
/
/
/
2
Cross-recessed small panhead screw
combination M3X8
3
Sample probe
801-1805-00003-00
/
4
Sample Probe Wipe Block
801-1805-00004-00
/
801-3003-00015-00
/
5
Rotation
Motor
Position
Sensor
Assembly
6
Cross-recessed panhead screw M3X4
/
/
7
Sensor package
801-3001-00055-00
/
8
Rubber washer + positioning bush
/
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
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
/
/
ID
Remarks
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
/
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
/
/
/
/
/
/
043-009250-00
/
/
/
2
3
4
5
Electrode of platinum filament
O-ring 21.2X1.8 silicone A50
Pool cover of RBC
Stainless cross recessed pan head
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
8.2.10 Pump Assembly
8.2.10.1 Explosive View
8.2.10.2 Bill of Materials
Maintenance
ID
Material description
1
Rotation waste pump
6
Pump connecting cable (white connector)
2
Pump fixing plate
/
/
3
Rubber ring
/
/
4
Rubber ring positioning bush
/
/
/
/
spare part ID
/
Remarks
/
/
Cross-recessed small panhead screw
5
combination GB/T9074.8 M3X8 with
environment-friendly color-zinc coating
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
6
Cross-recessed panhead screw
/
Power unit back plate
/
/
024-001032-00
/
GB/T9074.8 M3X8
7
8
9
10
FAN 12Vdc 40*40*10MM 4.1cfm 25dB
300mm
M3 hex nut with washer
Filter power 115/250VAC6A panel
mount
Cross recessed countersunk head
screws GB/T819.1-2000 M3X6
No.: HXQ-19001-New 3-DIFF
/
/
/
Version: 1.0
IVD Global Technical Support Dept.
8.2.12 Reagent Detection Assembly
8.2.12.1 Explosive View
8.2.12.2 Bill of Materials
ID
1
Material description
Maintenance spare part ID
Remarks
/
/
Reagent detection assembly
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
Hexagon spanner (1 suite)
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
components. Be careful not to break the cables or the connectors during
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).
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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).
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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).
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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).
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
3.
For the debugging and verification information of a certain component, refer to Chapter
11.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
8.4.13 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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
8.4.15 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);
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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;
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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).
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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);
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
◼
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;
8.4.30 Remove the Recorder
1.
Open the recorder cover and remove the 2 M3X6 screws;
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
9 Troubleshooting
Error
Error
Trigger
Related Repair
Troubleshooting
Name
Code
Mechanism
Parts and Tools
Guidance
AD
reference
Main
0x010001
voltage out of
control
01
range
2.6]V
board
error
[2.4,
0x010001
EEPROM data
02
incorrect
051-001714-00
Replace
the
Master Board PCBA
control board
main
1. Check whether the
button cell of the main
control
board
is
installed;
2. Replace with a new
The
time
button cell, and set up
indicated
by
M05-010R03--the date and time in the
System
0x010002
the
system
Lithium battery
clock error
01
clock is earlier
051-001714-00
than
Master Board PCBA
setup screen. Save the
settings, shut down the
analyzer
and
then
2000-01-01
restart;
3. If the error still exists
after
restarting
the
analyzer, replace the
main control board.
Constant
0x010003
01
current source
voltage out of
Power
range [47, 63]V
error
+12V
051-001714-00
Replace
Master Board PCBA
the
main
control board
115-025646-00
Power box assembly
analog
0x010003
Check
009-004354-00
voltage out of
02
whether
the
DC
output of the power
power cord
range [11, 14]V
board is normal using a
Multimeter
0x010003
-12V
No.: HXQ-19001-New 3-DIFF
analog
multimeter. If the output
Version: 1.0
IVD Global Technical Support Dept.
03
voltage out of
is
range
with
[-14,
-9]V
abnormal,
a
replace
new
power
board;
+12V
Unplug and reconnect
power
0x010003
voltage out of
the
range [11, 14]V
replace with a new one;
24V
If the error still exists,
04
power
0x010003
power
cord,
voltage out of
replace
range [20, 30]V
control board.
05
the
or
main
115-025649-00
Diluent Pre_heating
Preheat
Preheat
bath
assembly
bath
0x010004
temperature
051-001714-00
01
out
Master Board PCBA
Go to the status screen
009-004367-00
and check whether the
TempSensor Wire
error exists;
Multimeter
2.
115-015677-00
temperature
Diluent temperature
connecting cable, and
Diluent
detection unit
main control board in
turn.
temperatu
re sensor
of
range
(0,70) ℃
error
Diluent
temperatu
0x010004
temperature
051-001714-00
re sensor
02
out
Master Board PCBA
of
range
(0,70) ℃
error
Check
the
sensor,
009-004367-00
TempSensor Wire
Multimeter
Searching
for
115-025639-00
1.
the sensor: not
Syringe assembly
self-test to see whether
inside
009-004357-00
the error still exists;
Photosensor Wire for
2. Check the syringe,
the
Perform
syringe
Syringe
0x02nn01
sensor
area
01
after the action
Motor
syringe
is
009-004355-00
connecting cables, and
(after
Syringe Motor Wire
main control board in
compensation);
801-3003-00027-00
turn.
module
assembly,
error
No.: HXQ-19001-New 3-DIFF
completed
Version: 1.0
IVD Global Technical Support Dept.
2. Leaving the
10ml syringe (FRU)
sensor
115-027479-00
area:
0x02nn01
still inside the
250ul syringe (with
02
sensor
connector)
area
after the action
801-3003-00015-00
is completed;
Motor
sensor
position
assembly
(FRU)
0x02nn01
051-001714-00
Other error.
03
Master Board PCBA
Lubricating grease
Searching
for
the sensor: not
009-004356-00
0x02nn02
inside
Sample Motor Wire
01
sensor
the
area
1. Perform aspiration
009-004357-00
module self-test to see
after the action
Photosensor Wire for
Aspiration
is completed;
Motor
module lift
Leaving
115-025638-00
mechanis
sensor
whether the error still
exists;
the
2. Check the sensor,
area:
Sampling assembly
0x02nn02
still inside the
801-3001-00055-00
02
sensor
Sensor assembly 1
connecting
m error
cables,
main control board, and
area
aspiration
after the action
051-001714-00
is completed;
Master Board PCBA
module
in
turn.
Lubricating grease
0x02nn02
Other error.
03
Current
009-004356-00
1. Perform aspiration
position
Sample Motor Wire
module self-test to see
Aspiration
unknown;
009-004357-00
whether the error still
module
Searching
Photosensor Wire for
exists;
rotary
the
Motor
2. Check the sensor,
0x02nn03
01
for
target
mechanis
0x02nn0
sensor:
not
115-025638-00
connecting
m error
302
inside
the
Sampling assembly
main control board, and
area
801-3003-00015-00
aspiration
Motor
turn.
sensor
after the action
No.: HXQ-19001-New 3-DIFF
position
Version: 1.0
cables,
module
in
IVD Global Technical Support Dept.
is completed;
sensor
assembly
(FRU)
051-001714-00
0x02nn0
Master Board PCBA
Other error.
303
Lubricating grease
The
reagent
Diluent
0x030001
detection
ran out
01
reports
Liquid
no
diluent
The
Lyse
ran
out
051-001621-00
detection
board PCBA
Check related tubes,
043-000829-00
reagent,
Reagent
detection tube, liquid
detection
reagent
tube
detection
board,
009-004360-00
connecting cables, and
Liquid Detect Board
main control board in
Wire
turn
reagent
0x030001
detection
02
reports
no
diluent
051-001714-00
Master Board PCBA
Floater status:
1. Check once
in startup, and
115-013091-00
the
Waste container cap
status
is
full;
assembly
Check
the
floater,
0x040001
2. Check for 3
009-004361-00 Float
connecting cable, and
01
times when the
and
main control board in
analyzer
Wire
Waste
container
Aspirate
Key
full
is
turn
idled, and the
051-001714-00
results all show
Master Board PCBA
that the status
is full.
Preheat
115-025649-00
Preheat
bath
bath
Check
Diluent
0x050001
temperature
temperatu
the
diluent
heating
heating assembly and
assembly
01
higher
re is too
than
main control board in
051-001714-00
45℃
high
No.: HXQ-19001-New 3-DIFF
turn
Master Board PCBA
Version: 1.0
IVD Global Technical Support Dept.
115-025649-00
Preheat
Preheat
bath
0x050001
temperatu
bath
Diluent
heating
Check the connecting
temperature is
assembly
cable of the heater,
2.0 ℃
051-001714-00
diluent
lower
heating
02
re is too
than the target
Master Board PCBA
assembly,
and
main
low
temperature
009-004359-00 Heat
control board in turn
Driver Wire
Make sure the ambient
Diluent
temperature falls in the
115-015677-00
temperatu
Diluent
claimed
running
Diluent temperature
re
goes
0x050002
temperature is
temperature.
detection unit
beyond
01
higher
than
Check
the
diluent
051-001714-00
higher
limit 45℃
temperature
detection
Master Board PCBA
limit
unit and main control
board in turn.
Make sure the ambient
temperature falls in the
Diluent
115-015677-00
Diluent
claimed
temperatu
0x050002
re
running
Diluent temperature
temperature is
goes
temperature.
detection unit
02
lower than limit
beyond
2. Check the
diluent
051-001714-00
5℃
temperature
lower limit
detection
Master Board PCBA
unit and main control
board in turn.
115-025643-00
Waste
1. Go to the Temp &
pump
Pressure screen, and
assembly
check whether the error
115-025641-00
exists;
Vacuum/Pressure
2. Check the waste
Chamber
pump
801-3201-00003-00
connecting cables of
3-way
the valves and pump in
Pressure out of
Vacuum
0x060001
the
01
specified
range
pressure
and
the
by
abnormal
the sequence
No.: HXQ-19001-New 3-DIFF
Valve
(Mindray)
turn.
801-3201-00002-00
3. Check the vacuum
2-way
chamber, valves and
Valve
Version: 1.0
IVD Global Technical Support Dept.
(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
voltage
aperture
range
7.5V-18V
(for
is
both
WBC and RBC count)
For
dual-bath
analyzers
(BC-30/31/30e/20s/21s
/30s/31s):
⚫
The normal WBC
aperture
voltage
115-025644-00 RBC
Clogging(
0x070001
RBC
range
aperture
is
bath assembly
RBC)
02
6.5V-14.5V
voltage high
PROBE CLEANSER
⚫
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;
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
3.
Perform
probe
cleanser maintenance;
4. Uninstall and clean
the aperture.
1.
Check
instrument,
the
including
whether the earthing
screws are normal, and
whether the shielding
WBC
Detect
strong
box is open;
channel
0x070006
interfering
signal
2. Search for external
/
01
signal in WBC
source of interference,
channel
e.g.
interferenc
whether
the
e
external power supply
is stable, and whether
there
is
any
nearby
object
producing
strong interference.
1.
Check
instrument,
the
including
whether the earthing
screws are normal, and
whether the shielding
RBC
Detect
strong
box is open;
channel
0x070006
interfering
signal
2. Search for external
/
02
signal in RBC
source of interference,
channel
e.g.
interferenc
whether
the
e
external power supply
is stable, and whether
there
nearby
is
any
object
producing
strong interference.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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
Aperture
1.
voltage in WBC
temperature
voltage
0x070003
counting
abnormal(
01
process
WBC)
lower
is
If
the
diluent
sensor
115-025645-00 WBC
error is reported at the
bath assembly
same time. deal with it
than
first;
7.2V.
2. Check the model of
the diluent;
3. Check whether there
Aperture
Aperture
is leakage or overflow;
voltage in RBC
voltage
0x070003
abnormal(
02
115-025644-00 RBC
4.
counting
Uninstall
the
bath assembly
process is too
aperture,
and
make
low
sure the sealing ring is
RBC)
clean.
1.
Make
sure
the
models of the reagents
Startup
Backgrou
are correct;
0x070004
background
01
results
nd
PROBE CLEANSER
abnormal
2. Make sure the signal
line is grounded safely,
unqualified
and the installation of
the shielding box is
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
reliable;
3.
Perform
probe
cleanser maintenance;
IP
Find instrument
Contact
the
network
IP
administrator
to
conflicting
0x080001
address
with
that of a
/
re-assign
a
new
IP
01
conflict
host
in
the
address and modify the
network
setting
No paper
or
0x090001
No
paper
01
paper jam
0x090001
Other
02
error
or
No paper or paper
Check whether there is
jam
no paper or paper jam
paper
jam
Other
Printer
error
other
Please
contact
the
printer
printer
error
than no paper or
service department of
paper jam
the printer supplier.
1. Check whether the
data wire of the printer
Printer not
0x090001
Printer
connected
03
connected
not
Printer
not
connected
is connected properly
to the instrument.
2. Check whether the
printer works properly.
Check
whether
the
Recorder
Recorder
0x090002
Recorder
connecting cable of the
communication error
recorder
communication
error
01
is
properly
error
connected.
1. Check whether there
is no paper in the
No paper in the
No paper
No
0x090002
recorder
02
recorder cover
paper
in
the
recorder;
or
in
recorder
recorder or recorder
2. Check whether the
cover open
front
cover
of
the
open
recorder
is
properly
closed.
Recorder
0x090002
Recorder print
Recorder print head
1. Check whether the
error
03
head
overheated
recorder print head is
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
overheated
overheated;
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
2. Network between
network between the
the instrument and
instrument and the LIS
LIS disconnected; 3.
system works well;
Incorrect IP address
3. Check the instrument
or port in LIS.
IP address and port for
Communi
cation
0x0A0001
Communicatio
disconnec
01
n disconnected
ted
LIS
connection
are
properly configured.
Make
sure
the
LIS
Protocol
Protocol
Communi
analyzing
system is designed in
analyzing error
0x0A0001
cation
error
in
02
error
in
the
consistence
with
the
the
communication
protocol
provided
by
process
the manufacturer of the
communication
process
instrument
1. Check whether the
LIS
1. Network cable not
acknowledgme
well connected;
0x0A0001
nt overtime in
2.
03
the
between
communication
instrument
process
disconnected.
network
Communi
cable
is
properly connected;
Communication
cation
2. Check whether the
LIS
and
error
network between the
instrument and the LIS
system works well;
115-025651-00 LCD
assembly (8.4″)
Screen
flickering
115-039856-00 LCD
/
/
See section 7.9.2
or
assembly(8.4")
blackout
009-007651-00
LCD‘s wire
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
115-025652-00 LCD
assembly (10.4″)
009-007650-00
LCD
screen
connecting wire
051-001714-00
Master Board PCBA
Multimeter
021-000271-00
Touch panel resistive
8.4inch 4-wires
009-004655-00
Small
touch
panel
wire
Screen
used
801-3110-00184-00
/
/
improperly
Touch
screen,
See section 7.9.4
10.4″
009-004366-00
Touch
panel
connection wire
051-000881-00 6301
Touch screen control
board PCBA
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
10 Adjustment
10.1 Adjusting Mechanical Positions
Figure 10-1
Step
1.1
Action
Point of
Criteria of
Control
Control
Tap "Service > "Sample Probe Debug". Go to
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 singlebath analyzers
bath position
1.3
Tap "Middle position" to make the sample probe
Fine
The
come out of the probe wipe. Adjust the position
adjustment of
probe should
finely to make the sample probe point at the
the
not
contact
center of the bath cover, make sure that the
probe
the
bath
sample probe does not contact the bath
position
assembly, and then secure the 4 screws. The
relation to the
The
torsion for the screws is 3.2 to 4.5 kgN.
bath position
should
sample
in
sample
assembly.
screws
well fixed.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
be
IVD Global Technical Support Dept.
Tap "Initial position", and then "Down position".
Figure 10-2
Figure 10-3
Check whether the sample probe contacts the
bath. If there is contact, adjust the relative
RBC bath (not configured for singlebath analyzers)
1.4
Adjust the screws in the front
and back positions
position again as instructed by steps in Section
1.2-1.4, and do the check again to see if the
position is adjusted properly. The sample probe
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.
WBC bath
Adjust the screws on the left
and right positions
Only after you tap "Initialize", the other three buttons will be enabled. Only after you tap
"WBC Bath"/"RBC Bath", the "Middle position" and "Down position" buttons will be
enabled.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Figure 10-4
Fixture
3008-J02 Probe wipe positioner
Steps
Action
For
dual-bath
analyzers,
tap
"Initial
Point of
Criteria of
Control
Control
Adjust
the
1.
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.
The sample probe must contact the bottom of the fixing
device.
The
contact
the bath
1.5
assemb
ly.
2. The
screws
should
be
well
fixed.
1.6
Tap "Height-fixed pos." to make the
Adjust
sample probe stays above the WBC bath.
position of the
probe
Use the probe wipe positioner to adjust the
sample probe in
contact
position of the sample probe in relation to
relation to the
probe
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
the
The
sample
must
the
wipe
IVD Global Technical Support Dept.
Figure 10-5
1.7
Tap "Initial position", and then randomly
Check
tap "WBC Bath", "Aspiration Pos." and
position of the
probe should not
"RBC Bath" to check whether the sample
sample probe
scratch
probe scratches other components.
the
The
sample
other
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.
Fasten the
panhead screws
on the fixing
device
No.: HXQ-19001-New 3-DIFF
2. Before positioning the probe wipe, be sure to tap "Height-fixed pos." to make the sample
probe stays above the WBC bath because the rotary motor changes the sample probe
height in the vertical position. Do not perform height fixing on other positions. It is
forbidden to click "WBC Bath" directly.
Version: 1.0
IVD Global Technical Support Dept.
10.2 Adjusting Analysis Components
10.2.1 Counting Channel Test
Figure 10-6
Step
Action
Point of
Control
Criteria of Control
Open the shielding box of the counting
4.1
bath, and run blank counts for several
times in whole blood mode;
4.2
This does not exist for
single-bath analyzers
Observe the whole counting process, and
Aspiration
No gas column in the
make sure there is no gas column in the
tubing,
aspiration
aspiration tubing and no liquid suspended
probe, counting
sample
at the sample probe. Otherwise, replace
bath
liquid suspended at the
tubing
and
preparation,
no
the tubing. Check and make sure that
sample
there is no gas column in the sample
tubes fulfilled with liquid
preparation tubing, and tubes of the WBC
without gas column.
bath and RBC bath are fulfilled with liquid
without any bubble.
No.: HXQ-19001-New 3-DIFF
sample
Version: 1.0
probe,
related
IVD Global Technical Support Dept.
4.3
Observe the whole counting process, and
WBC bath, RBC
No
splashes
check whether the liquid level is normal
bath
dispensing
when
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
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;
4.4
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.
"Aperture voltage RBC" and "Aperture
voltage WBC".
4.5
Install the shielding box of the bath and fix
Secure
it with M3X8 screws. Secure the screws
screws.
the
using a cross-head screwdriver.
4.6
Start the count again. Observe the sample
Sample
probe
probe action in the whole process. There
position
in
should be no interference between the
relation to the
sample probe and the shielding box while
bath
mixing the liquid in the bath.
box position
Sample probe position in
relation
to
the
bath
shielding box position
shielding
Note: the gas column mentioned above is a large bubble that divides the liquid into segments in the
tubing.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
11 Debugging and Validation After
Servicing
Component Name
Master
Board
Service
Material ID
051-001714-00
PCBA
Adjustment Requirement
Validation
1. Back up the configuration
Version information correct
data as instructed by the
prompt on the screen;
2.
Check
the
version
information at the "Version
Info" screen.
Syringe
transfer
115-020624-00
Calibrate again
Check the repeatability
1. Make sure that there is
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
Assembly
no bent-over of tubes, and
Rotation Motor Pos
Sensor Assy
801-3003-00015
no interference between the
-00
tubes and the front plate,
fluidic component partition,
Sensor Package
801-3001-00055
right door, motors, valves,
-00
wire
harness
retainers
when the aspiration module
Sample
Probe
Wipe Block
801-1805-00004
-00
is
moving
vertically
or
horizontally;
2. Make sure that the tubes
Sample probe
801-1805-00003
-00
are not deformed when
passing through the wire
harness retainers;
3. Make sure that the inlet
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
and outlet tubes of the
probe wipe are not bent
over
and
interference
there
is
when
no
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
Assembly
1. Adjust the mechanical
position
of
the
Check the repeatability
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
Assembly
1. Adjust the mechanical
1. Check the repeatability;
position
2. Make sure the HGB
of
the
sample
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
115-049501-00
No.: HXQ-19001-New 3-DIFF
1. Adjust the mechanical
1. Check the repeatability;
Version: 1.0
IVD Global Technical Support Dept.
Assembly
position
of
the
sample
probe in relation to the bath;
2. Make sure the HGB
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
plate welding piece
Adjust
the
mechanical
position of the RBC bath
Make
sure
that
the
aspiration module does not
come into contact with the
RBC bath when it moves up
and down above the RBC
bath
HGB assembly
Vacuum/Pressure
115-025640-00
115-025641-00
Perform
gain
Make sure the HGB blank
calibration
voltage is 4.1V.
/
Make sure that bath can be
Chamber
Waste
HGB
emptied
pump
115-025643-00
normally,
and
vacuum can be built up
assembly
normally.
2-way
Valve
(Mindray)
3-way
Valve
(Mindray)
801-3201-00002
/
1. Make sure the inlet and
-00
outlet
are
in
correct
801-3201-00003
directions;
-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
hydraulic
3-way
115-015967-00
valve
No.: HXQ-19001-New 3-DIFF
/
1.
Make
sure
that
the
connections to N.C, N.O,
Version: 1.0
IVD Global Technical Support Dept.
(3106)
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
(BC-30S)
10
Make sure that the touch
screen works properly
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
Touch Screen
Short Gasket, IPM8
Touch Screen
Touch
screen,
10.4″
Touch
047-005535-00
047-005536-00
801-3110-00184
-00
panel
021-000271-00
resistive 8.4 inch
4-wires
LCD
assembly
115-025652-00
assembly
115-039856-00
Reagent pre-heater
115-049623-00
(10.4″)
LCD
(8.4″)
assembly
1.
The
J9
and
3-way
Make
that
the
connector C10 must be
temperature values are in
inserted to the end;
specified
2. Enter the parameters
status screen
recorded by FRU in the
temperature
screen
No.: HXQ-19001-New 3-DIFF
sure
to
calibration
attain
new
Version: 1.0
ranges
at
the
IVD Global Technical Support Dept.
temperature values.
Lithium battery 3V
M05-010R03---
35mAh D12.5*2.0
SD
card
8GB
023-001056-00
Class10
Set time and date at the
The date displayed after
Date/Time Setup screen.
restarting the analyzer is
Save the setting and shut
the same as that before the
down the analyzer.
shutdown.
1. Back up the data before
/
replacing the SD card (if
possible);
2. Restore the configuration
data.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
12 Service BOM
ID
115-025638-00
021-000271-00
023-000866-00
023-001524-00
024-001032-00
041-020880-00
042-005948-00
042-005949-00
042-011528-00
042-011531-00
042-020906-00
042-020086-00
042-011538-00
042-020088-00
043-000711-00
043-000829-00
043-007675-00
043-005463-00
043-005464-00
043-005810-00
043-008994-00
Name
Sampling assembly
touchpanel resistive 8.4inch 4-wires
Handheld Barcode Scanner
SDcard 8GB Class10
FAN 12Vdc 40*40*10MM 4.1cfm 25dB 300mm
Swab adjuster
top signal shield
bottom signal shield
shielding box
key mounting plate
right door(3008)
right door (3011, 3012)
top cover
top cover (3011, 3012)
filter
reagent detection tube
nel assembled(BC-20S)
panel assembled(BC-20S)
panel assembled(BC-30S)
[Aspirate] key(BC-20S)
key(BC-30S)
043-005587-00
043-007674-00
043-008298-00
043-008299-00
043-008406-00
043-008407-00
043-008300-00
043-008408-00
043-009251-00
043-010034-00
047-005535-00
047-005536-00
047-016362-00
047-016363-00
051-001621-00
051-001714-00
051-001857-00
051-001319-00
051-002708-00
051-002911-00
115-013091-00
Front Cover（10inches for bid）
No.: HXQ-19001-New 3-DIFF
Front Cover(8inches for bid)
front cover (BC-10)
front cover (BC-20)
front cover (BC-11)
front cover (BC-21)
front cover (BC-30)
front cover (BC-31)
front cover (BC-30e)
front cover (BC-10e)
LONG GASKET, IPM8 TOUCH SREEN
SHORT GASKET, IPM8 TOUCH SREEN
10INCH TOUCHSCREEN LONG GASKET
10INCH TOUCHSCREEN SHORT GASKET
Liquid detect board PCBA
Master Board PCBA
3008 indicate board PCBA
3107 Power Source PCBA
3206 Power Board PCBA for Burning
3008 Power Supply PCBA
waste capsule assembly
Version: 1.0
115-015677-00
115-015967-00
115-025639-00
115-025640-00
115-025641-00
115-025642-00
115-025643-00
115-025644-00
115-025645-00
115-049501-00
115-050158-00
115-025646-00
115-054722-00
115-025647-00
115-025648-00
115-045852-00
115-049564-00
115-025649-00
115-049623-00
115-025651-00
115-025652-00
115-025654-00
115-027955-00
115-039857-00
115-039858-00
115-045934-00
115-045935-00
115-045936-00
115-046023-00
115-046024-00
115-046025-00
115-039856-00
115-039901-00
115-025715-00
115-027479-00
115-028170-00
115-028171-00
115-030832-00
115-036143-00
801-1805-00003-00
801-1805-00004-00
801-1805-00023-00
801-2800-00016-00
No.: HXQ-19001-New 3-DIFF
IVD Global Technical Support Dept.
diluent temperature detecting asm
SMC 3-way valve(3106)
Syringe assembly
HGB module
Vacuum/Pressure Chamber
Reagent detector assembly
Waste pump assembly
RBC Bath Assembly
WBC Bath Assembly
Single Pass Bath Assembly
Single Pass Bath Assembly(no Cell Ruby )
Power box assembly (applicable to analyzers
with
software
versions
earlier
than
V01.07.00.2179)
power pack assembly (applicable to analyzers
with software version V01.07.00.2179 and later)
[Aspirate] key assembly
Left Door Assembly
Left Door Assembly (3011, 3012)
Left Door Assembly (3008)
Reagent pre-heater assembly
Reagent pre-heater assembly
LCD assembly(8.4")
LCD assembly(10.4")
Front cover assembly(10.4")
Front housing assembly(BC-31S)
Front housing assembly(BC-21S)
Front cover assembly(8.4")
Front cover assembly(BC-10)
Front cover assembly(BC-20)
Front cover assembly(BC-30)
Front cover assembly(BC-11)
Front cover assembly(BC-21)
Front cover assembly(BC-31)
LCD assembly(8.4")
Display Module
Air pump assembly
250ul syringe(with nozzle)
tube package
connector package
SD Card
Preventive maintenance material pack
Sample Probe
SAMPLE PROBE WIPE BLOCK
Isolation Chamber
Recorder Module
Version: 1.0
801-2800-00018-00
801-3001-00055-00
801-3003-00015-00
801-3003-00027-00
801-3007-00014-00
801-3007-00029-00
801-3110-00167-00
801-3110-00184-00
021-000279-00
801-3201-00002-00
801-3201-00003-00
M05-010R03--M07-00131F--M6G-020006---
IVD Global Technical Support Dept.
CAP Component for Diluent
sensor package
Rotation Motor Pos Sensor Assy
10ml Syringe
3007 switch(FRU)
3007 CAP Component for LYSE(FRU)
Support panel for diluent bottle
Touch screen 10.4'
Touch screen 10.4" 4-line
2-way Valve (Mindray)
3-way Valve (Mindray)
Lithium battery 3V 35mAh D12.5*2.0
FUSE Time-lag 250V 3.15AD5X20
Tubing,Silicone,1/16"ID,1'
M6G-020056--M90-000026--M90-100009--M90-100012--M90-100014--M90-100026--M90-100027--M90-100028--M90-100028-01
M90-100028-03
Tube EVA,ID:1/16",OD：1/8"，clear
M90-100031--M90-100048--M90-100050--M90-100066--M90-100071---
tube.PTFE，1.7mmIDX2.55mmOD
No.: HXQ-19001-New 3-DIFF
Tube.PTFE,1/32"X1/16",3000074,100ft/coil
FemaleLuer,1/4-28UNF,1/8"ID
Lock Nut, 1/4-28UNF, White Nylon
LockNut, 1/4-28UNF, Red Nylon
Male LuerPlug, White
StraightReduction,1/8"&3/32"ID
Tee,400Barb,3/32"ID,White Nylon
Straight,400Barb,3/32"ID,White
Y,400Barb,3/32"ID,White Nylon
Coded LockRing, White
Coded Lock Ring, For FTLLB or FTLB, Red
Elbow Reduction,1/8"&3/32"ID,White
Tubing.3/32"X5/32",ND-100-65,Tygon
Version: 1.0
IVD Global Technical Support Dept.
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Reagent
detectio
n
C23
T7
T54
J11
T47
T11
SV07
T23
T13
C4
T6
T8
C5
SV05
RBC
WBC
C22
SV04
Isolation
chamber 2
J3-T34J4
T26
T40
T17
T12
T43
Probe
wipe
T55
C24
T1
T29
T28
C21
T53
VC
C11
J7-T45J8
T27
T22
SV03
C9
C12
T46
C8
J5-T44J6
C10
T39
T41
T16
T21
T42
T9
SV01
T15
C26
SV08
SV06
T2
C16
Temperatur
e Sensor
C15
SV09
T56
SPB
T36
T38
C25
C3
C7
T25
J1-T33J2
C6
T37
T20
T3
T35
T57
SV02
C1
Isolation
chamber
1
J12-T51-P1
J9-T52-J10
T4
T10
T14
C13
C14
T49 T49
Lyse bottle
Preheat
bath
T48
T19
T5
T24
C2
T50
Diluent
container
C18
SR
Waste
container
Transducer
WASTE
C18
C17
LP
T30
T32
C17
T31
Figure 13-1 Fluidic diagram for BC-30s/31s/20s/21s
No.: HXQ-19001-New 3-DIFF
Version: 1.0
GP
T54
IVD Global Technical Support Dept.
T10
T7
T6
T8
T23
SV07
SV05
RBC
WBC
C22
T38
SV08
T26
T40
T17
T12
T43
Probe
wipe
C10
T55
C24
T1
T29
T28
C21
T53
VC
C11
J7-T45J8
T27
T22
SV03
SV01
C9
J5-T44J6
C8
C12
T46
T39
T41
T16
T21
T42
T9
T15
C26
SV09
SV06
T2
C16
Temperatur
e sensor
C15
SV04
T56
SPB
T36
T57
C25
C3
C7
Isolation J3-T34J4
chamber
2
C6
T37
T3
T20
T35
T25
J1-T33J2
SV02
C1
Isolation
chamber
1
J11-T51-P1
J9-T52-J10
T4
C13
C14
T49 T49
Lyse bottle
Prehea
t bath
T48
T19
T5
T24
C2
SR
Waste
containe
r
Transducer
WASTE
C18
C17
LP
T31
Figure 13-2 Fluidic diagram for BC-30/31/30e
No.: HXQ-19001-New 3-DIFF
Version: 1.0
T30
T50
Diluent
container
C18
T32
C17
GP
IVD Global Technical Support Dept.
C4
T14
C7
C6
T12
C25
T17
SV06
T27
T23
C13
T22
WBC
T24
TS
T25
C17
T29
SV05
C24
T33
T9
VAC
T10
PUMP_PRES
S
T28
J5-T34-J6
J1-T4-J2
T16
J7-T6-P1
SV02
SV01
T26
C14
C12
T46
T11
SV04
T20
Preheat
bath
T48
T18
PS
T21
T47
C5
T15
T19
SV07
T3
T37
Isolation
chamber
T7
T1
T30
T35
C18
C15
C20
T36
T45
C16
T32
J3-T31-J4
SV09
T2
SPB
SR
ASP(250uL)
DIL 10mL
C11
T44
Lyse T43
bottle
C9
C10
Diluent
container
C8
C19
Probe
wipe
T8
T38
SV08
T42
T39
C21
C22
T41
T40
PUMP_WASTE
Figure 13-3 Fluidic diagram for BC-20/21/10/11/10e
No.: HXQ-19001-New 3-DIFF
Version: 1.0
C23
Waste
container
IVD Global Technical Support Dept.
B.
Connection and Tube
List of M aterials in the F luidic D iagram for B C -30s/31s/20s/21s
N o.
M aterialT ype
1
S yringe
2
3
4
N am e in the
M aterialID
U nit
Q uantity
SR
115-015652-00
EA
1
W B C bath
W BC
115-025645-00
EA
1
R B C bath
V acuum
R BC
115-025644-00
EA
1
VC
115-015673-00
EA
1
LP
3001-10-07252
EA
1
D iagram
5
cham ber
Liquid pum p
6
G as pum p
GP
082-002497-00
EA
1
7
S am ple probe
SPB
3001-10-07059
EA
1
8
P robe w ipe
P robe w ipe
3001-30-06957
EA
1
115-002439-00
EA
1
3003-20-34949
EA
1
115-009948-00
EA
1
115-015677-00
EA
1
SV1
115-010088-00
EA
1
SV2
115-015967-00
EA
1
SV3
115-010089-00
EA
1
SV4
115-010089-00
EA
1
SV5
115-010088-00
EA
1
SV6
115-010088-00
EA
1
SV7
115-010088-00
EA
1
SV8
115-010088-00
EA
1
SV9
115-010088-00
EA
1
9
10
Isolation
Isolation
cham ber
cham ber 1
Isolation
Isolation
cham ber
cham ber 2
11
H eating bath
12
S ensor
13
14
15
16
17
18
19
20
21
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
P reheating
bath
T em perature
sensor
22
23
24
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -30s/31s/20s/21s
N am e in
N o. M aterialT ype
the
M aterialID
U nit
Q uantity
D iagram
25
R ubber tube
T1
082-000108-00
mm
240
26
R ubber tube
T2
082-000108-00
mm
210
27
R ubber tube
T3
082-000108-00
mm
270
28
R ubber tube
T4
082-000314-00
mm
20
29
R ubber tube
T5
082-000314-00
mm
20
30
R ubber tube
T6
3001-10-07069
mm
450
31
R ubber tube
T7
3001-10-07069
mm
60
32
R ubber tube
T8
3001-10-07069
mm
65
33
R ubber tube
T9
082-000108-00
mm
50
34
R ubber tube
T 10
M 6G -020055---
mm
1200
35
R ubber tube
T 11
082-000108-00
mm
50
36
R ubber tube
T 12
082-000108-00
mm
20
37
R ubber tube
T 13
082-000108-00
mm
20
38
R ubber tube
T 14
M 6G -020055---
mm
270
39
R ubber tube
T 15
M 6G -020054---
mm
1500
40
R ubber tube
T 16
082-000108-00
mm
440
41
R ubber tube
T 17
082-000108-00
mm
230
42
R ubber tube
T 19
3001-10-07069
mm
300
43
R ubber tube
T 20
3001-10-07069
mm
465
44
R ubber tube
T 21
3001-10-07069
mm
235
45
R ubber tube
T 22
M 90-100071---
mm
390
46
R ubber tube
T 23
3001-10-07069
mm
310
47
R ubber tube
T 24
3001-10-07069
mm
180
48
R ubber tube
T 25
3001-10-07069
mm
330
49
R ubber tube
T 26
3001-10-07069
mm
320
50
R ubber tube
T 27
082-000314-00
mm
20
51
R ubber tube
T 28
082-000314-00
mm
60
52
R ubber tube
T 29
M 90-100071---
mm
300
53
R ubber tube
T 30
082-000314-00
mm
120
54
R ubber tube
T 31
082-000314-00
mm
100
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -30s/31s/20s/21s
N am e in the
N o. M aterialT ype
M aterialID
U nit Q uantity
D iagram
55
R ubber tube
T 32
M 6G -020055--- m m
1500
56
R ubber tube
T 33
M 90-100031---
mm
160
57
R ubber tube
T 34
M 90-100031---
mm
160
58
R ubber tube
T 35
M 6G -020006---
mm
20
59
R ubber tube
T 36
M 6G -020006---
mm
20
60
R ubber tube
T 37
M 90-100071---
mm
210
61
R ubber tube
T 38
M 90-100071---
mm
220
62
R ubber tube
T 39
M 90-100071---
mm
70
63
R ubber tube
T 40
M 90-100071---
mm
30
64
R ubber tube
T 41
M 90-100071---
mm
130
65
R ubber tube
T 42
M 90-100071---
mm
140
66
R ubber tube
T 43
M 90-100071---
mm
90
67
R ubber tube
T 44
082-000109-00
mm
220
68
R ubber tube
T 45
082-000109-00
mm
380
69
R ubber tube
T 46
M 6G -020006---
mm
80
70
R ubber tube
T 47
3001-10-07069
mm
420
71
R ubber tube
T 48
3001-10-07069
mm
300
72
R ubber tube
T 49
A 21-000002---
mm
180
73
R ubber tube
T 50
A 21-000002---
mm
300
74
R ubber tube
T 51
082-000422-00
mm
400
75
R ubber tube
T 52
M 90-100031---
mm
700
76
R ubber tube
T 53
3001-10-07069
mm
40
77
R ubber tube
T 54
3001-10-07069
mm
600
78
R ubber tube
T 55
M 90-100071---
mm
45
79
T ransfer tube
T 56
3001-10-07069
mm
15
80
T ransfer tube
T 57
3001-10-07069
mm
15
81
T ransfer tube
J1
M 90-100071---
mm
25
82
T ransfer tube
J2
M 6G -020006---
mm
25
83
T ransfer tube
J3
M 90-100071---
mm
25
84
T ransfer tube
J4
M 6G -020006---
mm
25
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
L is t o f M a te ria ls in th e F lu id ic D ia g ra m fo r B C -
N o.
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
M a te ria l
T ype
T ransfer tube
T ransfer tube
T ransfer tube
T ransfer tube
T ransfer tube
T ransfer tube
T ransfer tube
T ransfer tube
S ilicone T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
T ube
C onnector
T ube
C onnector
T ube
C onnector
No.: HXQ-19001-New 3-DIFF
3 0 s /3 1 s /2 0 s /2 1 s
N a m e in th e
M a te ria l ID
D ia g ra m
J5
082-000710-00
J6
082-000710-00
J7
082-000710-00
J8
082-000710-00
J9
082-000055-00
J10
0030-20-13339
J11
082-000055-00
J12
082-000710-00
082-000108-00
P1
C1
M 90-100066--C2
M 90-100027--C3
M 90-100027--C4
M 90-100066--C5
M 90-100027--C6
M 90-100026--C7
M 90-100026--C8
M 90-100027--C9
M 90-100028--C 10
M 90-100028-01
C 11
M 90-100028-01
C 12
M 90-100028-03
C 13
M 90-100024--C 14
M 90-100009--C 15
M 6Q -030111--C 16
M 90-100009--C 17
M 6Q -030111--C 18
M 90-100009--C 21
M 90-100028-01
C 22
043-000892-00
C 23
043-000892-00
U n it Q u a n tity
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
20
20
20
20
20
20
20
20
200
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
EA
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
C 24
M 90-100100---
EA
1
C 25
M 90-100027---
EA
1
C 26
M 90-100027---
EA
1
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -30/31/30e
N o.
M aterialT ype
1
S yringe
2
3
4
N am e in the
M aterialID
U nit
Q uantity
SR
115-015652-00
EA
1
W B C bath
W BC
115-025645-00
EA
1
R B C bath
R BC
115-025644-00
EA
1
VC
115-015673-00
EA
1
V acuum
cham ber
D iagram
5
Liquid pum p
LP
3001-10-07252
EA
1
6
G as pum p
GP
082-002497-00
EA
1
7
S am ple probe
SPB
3001-10-07059
EA
1
8
P robe w ipe
P robe w ipe
3001-30-06957
EA
1
Isolation
Isolation
cham ber
cham ber 1
115-002439-00
EA
1
Isolation
Isolation
cham ber
cham ber 2
3003-20-34949
EA
1
115-009948-00
EA
1
115-015677-00
EA
1
SV1
115-010088-00
EA
1
SV2
115-015967-00
EA
1
SV3
115-010089-00
EA
1
SV4
115-010089-00
EA
1
SV5
115-010088-00
EA
1
SV6
115-010088-00
EA
1
SV7
115-010088-00
EA
1
SV8
115-010088-00
EA
1
SV9
115-010088-00
EA
1
9
10
11
H eating bath
12
S ensor
13
14
15
16
17
18
19
20
21
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
P reheating
bath
T em perature
sensor
22
23
24
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -30/31/30e
N am e in
N o.
M aterialT ype
the
M aterialID
U nit
Q uantity
D iagram
25
R ubber tube
T1
082-000108-00
mm
240
26
R ubber tube
T2
082-000108-00
mm
210
27
R ubber tube
T3
082-000108-00
mm
270
28
R ubber tube
T4
082-000314-00
mm
20
29
R ubber tube
T5
082-000314-00
mm
20
30
R ubber tube
T6
3001-10-07069
mm
450
31
R ubber tube
T7
3001-10-07069
mm
60
32
R ubber tube
T8
3001-10-07069
mm
65
33
R ubber tube
T9
082-000108-00
mm
50
34
R ubber tube
T 10
M 6G -020055---
mm
1200
35
R ubber tube
T 12
082-000108-00
mm
20
36
R ubber tube
T 15
M 6G -020054---
mm
1500
37
R ubber tube
T 16
082-000108-00
mm
440
38
R ubber tube
T 17
082-000108-00
mm
230
39
R ubber tube
T 19
3001-10-07069
mm
300
40
R ubber tube
T 20
3001-10-07069
mm
465
41
R ubber tube
T 21
3001-10-07069
mm
235
42
R ubber tube
T 22
M 90-100071---
mm
390
43
R ubber tube
T 23
3001-10-07069
mm
310
44
R ubber tube
T 24
3001-10-07069
mm
180
45
R ubber tube
T 25
3001-10-07069
mm
330
46
R ubber tube
T 26
3001-10-07069
mm
320
47
R ubber tube
T 27
082-000314-00
mm
20
48
R ubber tube
T 28
082-000314-00
mm
60
49
R ubber tube
T 29
M 90-100071---
mm
300
50
R ubber tube
T 30
082-000314-00
mm
120
51
R ubber tube
T 31
082-000314-00
mm
100
52
R ubber tube
T 32
M 6G -020055---
mm
1500
53
R ubber tube
T 33
M 90-100031---
mm
160
54
R ubber tube
T 34
M 90-100031---
mm
160
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -30/31/30e
N am e in
N o.
M aterialT ype
the
M aterialID
U nit
Q uantity
D iagram
55
R ubber tube
T 35
M 6G -020006---
mm
20
56
R ubber tube
T 36
M 6G -020006---
mm
20
57
R ubber tube
T 37
M 90-100071---
mm
210
58
R ubber tube
T 38
M 90-100071---
mm
220
59
R ubber tube
T 39
M 90-100071---
mm
70
60
R ubber tube
T 40
M 90-100071---
mm
30
61
R ubber tube
T 41
M 90-100071---
mm
130
62
R ubber tube
T 42
M 90-100071---
mm
140
63
R ubber tube
T 43
M 90-100071---
mm
90
64
R ubber tube
T 44
082-000109-00
mm
220
65
R ubber tube
T 45
082-000109-00
mm
380
66
R ubber tube
T 46
M 6G -020006---
mm
80
67
R ubber tube
T 48
3001-10-07069
mm
300
68
R ubber tube
T 49
A 21-000002---
mm
180
69
R ubber tube
T 50
A 21-000002---
mm
300
70
R ubber tube
T 51
082-000422-00
mm
400
71
R ubber tube
T 52
M 90-100031---
mm
700
72
R ubber tube
T 53
3001-10-07069
mm
40
73
R ubber tube
T 54
3001-10-07069
mm
600
74
R ubber tube
T 55
M 90-100071---
mm
45
75
T ransfer tube
T 56
3001-10-07069
mm
15
76
T ransfer tube
T 57
3001-10-07069
mm
15
77
T ransfer tube
J1
M 90-100071---
mm
25
78
T ransfer tube
J2
M 6G -020006---
mm
25
79
T ransfer tube
J3
M 90-100071---
mm
25
80
T ransfer tube
J4
M 6G -020006---
mm
25
81
T ransfer tube
J5
082-000710-00
mm
20
82
T ransfer tube
J6
082-000710-00
mm
20
83
T ransfer tube
J7
082-000710-00
mm
20
84
T ransfer tube
J8
082-000710-00
mm
20
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -30/31/30e
N o.
M aterialT ype
85
T ransfer tube
86
N am e in the
M aterialID
U nit
Q uantity
J9
082-000055-00
mm
20
T ransfer tube
J10
0030-20-13339
EA
1
87
T ransfer tube
J11
082-000710-00
mm
20
88
S ilicone T ube
P1
082-000108-00
mm
200
89
T ube connector
C1
M 90-100066---
EA
1
90
T ube connector
C2
M 90-100027---
EA
1
91
T ube connector
C3
M 90-100027---
EA
1
92
T ube connector
C6
M 90-100026---
EA
1
93
T ube connector
C7
M 90-100026---
EA
1
94
T ube connector
C8
M 90-100027---
EA
1
95
T ube connector
C9
M 90-100028---
EA
1
96
T ube connector
C 10
M 90-100028-01
EA
1
97
T ube connector
C 11
M 90-100028-01
EA
1
98
T ube connector
C 12
M 90-100028-03
EA
1
99
T ube connector
C 13
M 90-100024---
EA
1
100
T ube connector
C 14
M 90-100009---
EA
1
101
T ube connector
C 15
M 6Q -030111---
EA
1
102
T ube connector
C 16
M 90-100009---
EA
1
103
T ube connector
C 17
M 6Q -030111---
EA
1
104
T ube connector
C 18
M 90-100009---
EA
1
105
T ube connector
C 21
M 90-100028-01
EA
1
106
T ube connector
C 22
043-000892-00
EA
1
107
T ube connector
C 24
M 90-100100---
EA
1
108
T ube connector
C 25
M 90-100027---
EA
1
109
T ube connector
C 26
M 90-100027---
EA
1
No.: HXQ-19001-New 3-DIFF
D iagram
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -20/21/10/11/10e
N o. M aterialT ype
N am e in the
D iagram
M aterialID
U nit
Q uantity
1
R ubber tube
T1
082-000108-00
mm
240
2
R ubber tube
T2
082-000108-00
mm
270
3
R ubber tube
T3
082-000108-00
mm
220
4
R ubber tube
T4
M 90-100031---
mm
460
5
R ubber tube
T6
082-000422-00
mm
400
6
R ubber tube
T7
3001-10-07069
mm
320
7
R ubber tube
T8
3001-10-07069
mm
430
8
R ubber tube
T9
082-000108-00
mm
95
9
R ubber tube
T 10
082-000108-00
mm
130
10
R ubber tube
T 11
3001-10-07069
mm
270
11
R ubber tube
T 12
3001-10-07069
mm
450
12
R ubber tube
T 14
3001-10-07069
mm
600
13
R ubber tube
T 15
3001-10-07069
mm
300
14
R ubber tube
T 16
082-000108-00
mm
50
15
R ubber tube
T 17
M 6G -020055---
mm
420
16
R ubber tube
T 18
M 6G -020054---
mm
1500
17
R ubber tube
T 19
3001-10-07069
mm
60
18
R ubber tube
T 20
3001-10-07069
mm
65
19
R ubber tube
T 21
3001-10-07069
mm
350
20
R ubber tube
T 22
3001-10-07069
mm
330
21
R ubber tube
T 23
3001-10-07069
mm
230
22
R ubber tube
T 24
082-000314-00
mm
20
23
R ubber tube
T 25
M 90-100071---
mm
45
24
R ubber tube
T 26
M 90-100071---
mm
300
25
R ubber tube
T 27
3001-10-07069
mm
40
26
R ubber tube
T 28
M 90-100071---
mm
230
27
R ubber tube
T 29
082-000314-00
mm
60
28
R ubber tube
T 30
M 6G -020006---
mm
80
29
R ubber tube
T 31
082-000109-00
mm
460
30
R ubber tube
T 32
082-000108-00
mm
320
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -20/21/10/11/10e
N o.
M aterial
T ype
N am e in
the
M aterialID
U nit
Q uantity
D iagram
31
R ubber tube
T 33
M 6G -020006---
mm
20
32
R ubber tube
T 34
M 90-100031---
mm
160
33
R ubber tube
T 35
M 6G -020006---
mm
20
34
R ubber tube
T 36
M 90-100071---
mm
200
35
R ubber tube
T 37
082-000314-00
mm
40
36
R ubber tube
T 38
M 90-100071---
mm
250
37
R ubber tube
T 39
M 90-100071---
mm
260
38
R ubber tube
T 40
082-000314-00
mm
30
39
R ubber tube
T 41
082-000314-00
mm
120
40
R ubber tube
T 42
M 6G -020055---
mm
1500
41
R ubber tube
T 43
A 21-000002---
mm
180
42
R ubber tube
T 44
A 21-000002---
mm
300
43
R ubber tube
T 45
3001-10-07069
mm
15
44
R ubber tube
T 46
082-000314-00
mm
20
45
R ubber tube
T 47
082-000314-00
mm
20
46
R ubber tube
T 48
082-000108-00
mm
20
47
R ubber tube
J1
082-000055-00
mm
20
48
R ubber tube
J2
0030-20-13339
EA
1
49
R ubber tube
J3
082-000710-00
mm
20
50
R ubber tube
J4
082-000710-00
mm
20
51
R ubber tube
J5
M 90-100071---
mm
25
52
R ubber tube
J6
M 6G -020006---
mm
25
53
R ubber tube
082-000710-00
mm
20
54
R ubber tube
J7
P1
082-000108-00
mm
200
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -20/21/10/11/10e
N o.
M aterial
T ype
N am e in
the
M aterialID
U nit
Q uantity
D iagram
55
T ransfer tube
C4
043-000892-00
EA
1
56
T ransfer tube
C5
M 90-100027---
EA
1
57
T ransfer tube
C6
M 6Q -030111---
EA
1
58
T ransfer tube
C7
M 90-100009---
EA
1
59
T ransfer tube
C8
082-001140-00
EA
1
60
T ransfer tube
C9
082-001141-00
EA
1
61
T ransfer tube
C 10
M 6Q -030111---
EA
1
62
T ransfer tube
C 11
M 90-100009---
EA
1
63
T ransfer tube
C 12
M 90-100027---
EA
1
64
T ransfer tube
C 13
M 90-100100---
EA
1
65
T ransfer tube
C 14
M 90-100028-01
EA
1
66
T ransfer tube
C 15
M 90-100028-01
EA
1
67
T ransfer tube
C 16
M 90-100028-01
EA
1
68
T ransfer tube
C 17
M 90-100026--
EA
1
69
T ransfer tube
C 18
M 90-100026--
EA
1
70
T ransfer tube
C 19
M 90-100027---
EA
1
71
T ransfer tube
C 20
M 90-100027---
EA
1
72
T ransfer tube
C 21
M 90-100027---
EA
1
73
T ransfer tube
C 22
M 6G -030111---
EA
1
74
T ransfer tube
C 23
M 90-100009---
EA
1
75
T ransfer tube
C 24
M 90-100066---
EA
1
76
T ransfer tube
C 25
M 90-100027---
EA
1
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
List of M aterials in the F luidic D iagram for B C -20/21/10/11/10e
N o.
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
M aterialT ype
N am e in the
M aterialID
U nit
Q uantity
115-015652-00
115-025645-00
115-015673-00
3001-10-07252
082-002497-00
3001-10-07059
3001-30-06957
EA
EA
EA
EA
EA
EA
EA
1
1
1
1
1
1
1
115-002439-00
EA
1
115-015677-00
EA
1
SV1
115-010088-00
EA
1
SV2
115-015967-00
EA
1
SV4
115-010089-00
EA
1
SV5
115-010088-00
EA
1
SV6
115-010088-00
EA
1
SV7
115-010088-00
EA
1
SV8
115-010088-00
EA
1
SV9
115-010088-00
EA
1
D iagram
S yringe
SR
W B C bath
W BC
V acuum cham ber
VAC
Liquid pum p
P U M P _W A S T E
G as pum p
P U N P _P R S S
S am ple probe
SPB
P robe w ipe
P robe w ipe
Isolation
Isolation
cham ber
S ensor
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
E lectrom agnetic
valve
cham ber
T em perature
sensor
94
95
96
97
98
99
100
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
C.
Aspiration
Assembly
MotorX2
SensorX3
Hardware block diagram
Syringe
Assembly
MotorX1
SensorX1
Grounding
Power
Board
009-004354-00
Valves &
Pumps
X16
009-004358-00
Preheating
X1
Liquid
Detection
X2
Floater
009-004360-00
009-004361-00
009-004359-00
009-004357-00
009-004355-00
009-004357-00
009-004356-00
Aspirate
Key
009-004361-00
Power
Source
Motor
Power
Driving
Sensor
Liquid
Detection
Floater&
Aspiration
Recorder
(Side
Door)
009-004362-00
Recorder
Indicator 009-004363-00
Indicator
Board
Board
Camera
USB
USB
009-004364-00
009-004471-00
LCD
LVDS
Digital
Power
US
B
Main Control
Board
US
B
Front
Cover
Backlight
LCD Touch
Screen
(Transfer
Connection)
Touch
Screen
009-004366-00
009-004655-00
Preheating
Bth
009-004367-00
051-001714-00
Atmospheric
Pressure
HGB
Earthing
Temperature
Vacuum
Chamber
Diluent
009-004368-00
LA
N
RBC
Analog
Power
WBC
009-004369-00
009-004370-00
RBC
Bath
Shielding
Box
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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
D.
Material ID
Name
009-004355-00
Syringe
Wire
Motor
009-004356-00
Sample
Wire
Motor
Cables and Wires
Connecting
Socket on
the Main
Control
Board
J8
J7
009-004357-00
Photosensor
Wire for Motor
J12
009-004358-00
Valve and Pump
Wire
J9
009-004359-00
Heat Driver Wire
J11
009-004360-00
009-004361-00
Liquid
Detect
Board Wire
Float
and
Aspirate
Key
Wire
009-004362-00
Recorder wire
009-004363-00
Indicate
wire
009-004367-00
TempSensor
Wire
009-004371-00
J15
J16
board
Ground Wire for
Safety
No.: HXQ-19001-New 3-DIFF
J14
J19
J27
Connection
Connects
115-025639-00
Syringe
assembly
Connects
115-025638-00
Sampling
assembly
UP: connects upper motor
DOWN: connects down motor
Connects
115-025638-00
Sampling
assembly
UP: connects upper photosensor of
sampling assembly
LEFT: connects left photosensor of
sampling assembly
RIGHT: connects right photosensor of
sampling assembly
INJ: connects syringe photosensor
V1~V10:
connects
the
valve
corresponding to the division plate
printing
GAS: connects 115-025715-00 air pump
assembly
WAS: connects 115-025643-00 waste
pump assembly
Connects
115-025649-00
Reagent
pre-heater assembly
HT: connects the heater
TS: connects the Thermal protector
Reagent: connects the reagent pipes
Diluent: connects the diluent pipes
The white connector connects the
aspirate key
The black connector connects the float
Connects
115-002795-00
TR60-H
recorder
Connects 051-001857-00 3008 indicator
board PCBA
HEAT-TEMP:
detects
preheater
temperature detection
DIL-TEMP: detects diluent temperature
Connects the power assembly and the
middle power shutter
Version: 1.0
3101-20-68592
009-004369-00
009-004370-00
009-004372-00
009-004368-00
009-007651-00
009-004655-00
009-007650-00
009-004366-00
Cable of waste
pump
RBC signal wire
WBC signal wire
Module Ground
Wire
HGB signal wire
LCD‘s wire
Small
touch
panel wire
LCD connection
wire
Touch
panel
connection wire
No.: HXQ-19001-New 3-DIFF
IVD Global Technical Support Dept.
Weld to the BNC
J29
J30
/
J28
J24/J25
Connects the RBC bath
Connects the WBC bath
Connects the motor of the sampling
assembly and the motor of the syringe
assembly
Connects the HGB amp
Connects the 8.4 inch LCD
Connects the 8.4 inch touch panel
J26
Connects the 10.4 inch LCD
J24/J25
Connects the 10.4 inch touch panel
J26
Version: 1.0
IVD Global Technical Support Dept.
E.
Level 1
Sample
Analysis
Table Review
Level 2
√
√
/
/
Setup
Count
Setup
Graph
/
/
/
/
√
√
√
√
√
×
×
×
×
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
/
×
×
√
/
Date/Time Setup
Print setup
Communication
Shortcut Code
Setup
Lab Info Setup
×
√
√
√
×
√
√
√
√
√
√
√
×
√
√
×
√
√
/
×
√
√
/
√
√
√
×
√
√
×
√
√
√
√
√
/
√
√
√
/
/
/
×
√
√
√
√
√
√
√
√
/
×
√
√
/
×
√
√
/
×
√
√
/
/
√
×
√
√
√
√
Manual
Calibrator
Fresh blood
Background
Reproducibilit
y
Carryover
System Setup
Access
Management
Auxiliary
Setup
Setting
Parameters
Service
Service
√
X-B QC
Setup
Operator
Access Level
Administrator
/
QC
Performance
Level 3
/
L-J QC
Calibration
Menu Tree
Maintenance
Reagent
Setup
Gain Setup
Maintenance
Self-Test
Sample Probe
Debug
Gain
Calibration
Temperature
calibration
Screen Cal.
Advanced
No.: HXQ-19001-New 3-DIFF
Reference Unit
Setup
Reference Range
Setup
/
Version: 1.0
IVD Global Technical Support Dept.
Toolbox
Log
Counter
Temp
Pressure
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.
Status
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
F.
Product Model
Inspection
No.
Item
Appendix Table
SN
Description
1
Electrical
connections
Safe and reliable
earthing
2
Beeping
alarm
/
3
Time and date
Time and date
4
Version
Version
configuration
information
5
Mechanical
position
validation
Sample
probe
position in relation
to the WBC bath
6
Mechanical
position
validation
Sample
probe
position in relation
to the RBC bath
7
Counting
Channel Test
Result
Conclusion
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
No bubble
□OK □NG
□PASS □FAIL
No suspended
liquid
□OK □NG
□PASS □FAIL
Sample
probe
lower
position
normal
□OK □NG
□PASS □FAIL
There
are
bubbles
when
making bubbles
□OK □NG
□PASS □FAIL
There
are
bubbles
when
making bubbles
□OK □NG
□PASS □FAIL
No overflow or
contact
□OK □NG
□PASS □FAIL
See
the
diagrams in the
appendices
Having beeping
alarm
Correct time and
date
and
Whether there is
bubble
in
the
aspiration tubing
Whether there is
liquid suspended at
the sample probe
tip
Sample probe is
under the surface of
the liquid and does
not contact the
bottom of the bath
Whether there are
bubbles
when
making bubbles in
the WBC bath
Whether there are
bubbles
when
making bubbles in
the RBC bath
In the process of
making bubbles in
the WBC bath,
whether there is
No.: HXQ-19001-New 3-DIFF
Requirement
Correct version
See the section
of
"Adjusting
Mechanical
Positions"
See the section
of
"Adjusting
Mechanical
Positions"
Version: 1.0
IVD Global Technical Support Dept.
overflow,
and
whether
the
bubbles contact the
inlet tube
In the process of
making bubbles in
the
RBC
bath,
whether there is
overflow,
and
whether
the
bubbles contact the
inlet tube
Whether the WBC
bath is emptied
normally
Whether the RBC
bath is emptied
normally
Bath shielding box
installation
8
Instrument
maintenance
9
Background
test
10
Recorder
11
Shutdown
Sample
action
probe
Sample
tubing
probe
Perform
maintenance
and
cleaning
WBC
RBC
HGB
HCT
PLT
Print
analysis
results
Shutdown process
Tested by:
No.: HXQ-19001-New 3-DIFF
No overflow or
contact
□OK □NG
□PASS □FAIL
Emptied
normally
□OK □NG
□PASS □FAIL
Emptied
normally
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
Screws are well
fixed
No interference
when the sample
probe is in action
No interference
between
the
sample
probe
tubing and other
structures
Refer to the
operator's
manual
≤0.20×109/L
≤0.02×1012/L
≤1g/L
≤0.50%
≤5×109/L
Able to print
properly
No
error
message
or
alarm
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
Date:
Version: 1.0
IVD Global Technical Support Dept.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
New 3-DIFF
(AUTO) HEMATOLOGY ANALYZER
SERVICE MANUAL
Volume II
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
14Analyzer Installation
14.1 Preparations
Install the instrument properly as per the procedures introduced in this installation guide. The purpose of this
installation guide is
to ensure the safety and effective operations of the analyzer on site.
14.1.1 Tools
1. Blade or clipper
2. USB
3. Pipette (200ul)
4. Cross-headed screwdriver
14.1.2 Consumables
1. Plastic test tube
2. Pipette
3. Gloves
4. Chipless paper towel
5. Calibrator
6. Controls (Normal level)
14.2 Installation Requirements
14.2.1 Environment Requirements
Make sure the operating environment of the analyzer meets the requirements before installation, as shown
in table 2-1.
Ambient temperature
Table 2-1 Operating environment requirements
Normal-operation
Storage Environment Operation Environment
environment
requirements
10℃-35℃
-10℃～40℃
10℃～40℃
Relative Humidity
20%～85%
Atmospheric pressure 70kPa～106kPa
10%～90%
10%～90%
50kPa～106kPa
70kPa～106kPa
Besides, the installation environment must meet the requirements below:
A. The environment should be as free as possible from dust, mechanical vibrations and electrical
interference;
B. It is advisable to evaluate the electromagnetic environment prior to the operation of this analyzer. Make
sure the electromagnetic interference is less than CLASS B. Do not use this analyzer in close proximity to
sources of strong electromagnetic radiation;
C. Do not place the analyzer near brush-type motors, flickering fluorescent lights, and electrical contacts that
regularly open and close;
D. Do not place the analyzer on a slope;
E. Do not place the analyzer in direct sunlight or in front of a source of heat or drafts;
F. The environment shall be well ventilated;
Warning
Do not place the analyzer in a flammable or explosive environment.
Do not move the analyzer at will. Contact Mindray or your local distributor if you need to move them.
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Note
If the ambient temperature is out of the specified operating range, the analysis results may be unreliable.
14.2.2 Space Requirements
Check the site for proper space allocation. In addition to the space required for the analyzer itself, arrange
for:
A. At least 50 cm away from the walls for the left and right doors of the analyzer;
B. At least 20 cm away from the wall for the back plate of the analyzer;
C. Reserve enough room on or below the countertop to accommodate the containers of the reagents such as
diluent and lyse and waste containers.
D. The diluent container must be placed within 1.0 meter’s reach under the main unit, the lyse container must
be placed inside the main unit.
e. Minimum bearing weight of the laboratory platform: 20 kg
Note
Make sure all the requirements listed above are met. Otherwise, the performance of the analyzer might
compromise.
14.2.3 Power Supply Requirements
The power requirements of the analyzer are shown in Table 2-2. Before installing the machine, strictly check
that the power supply meets the specifications.
Voltage
Main unit
Table 2-2 Power supply requirements
Input Power
Frequency
(100V/-240V-) Allowance ±10%
≤300VA
(50Hz/60Hz)±1Hz
Warning
Make sure the analyzer is properly grounded.
Only install fuses of specified specification on the analyzer and the pneumatic unit.
Before turning on the analyzer, make sure the input voltage meets the requirements.
Use the original electrical wire shipped with the analyzer.
14.2.4 Confirming the Tube Type on Site
The following tube specifications can be used:
1.Ф12 - 15×75 mm evacuated collection tube (Without cap)
2. Ф 11 × 40 mm (1.5ml centrifuge tube) and 0.5ml centrifuge tube for pre-dilution and peripheral whole blood
mode;
3. Ф10.7×42 mm (Without cap size) closed small anticoagulant tube, 0.5ml, can be opened for testing,
suitable for peripheral whole blood mode. Recommended tube: BD's 0.5ml closed anticoagulation tube,
product number 365974.
14.3 Unpacking
14.3.1 Checking before Unpacking
Check if the package is intact before unpacking.
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14.3.2 Unpacking the Main Unit
1. The appearance of the main unit package is shown in Figure 2-1. Cut off the binding straps before
unpacking.
Figure 2-1 Exterior package of the main unit
2. Cut off the binding straps, and open the box. You can see the accessory bag in the box, and remove the
accessory bag, as shown in Figure 2-2
.
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Figure 2-2 Remove the accessory bag of the main unit
3. Remove the protection foam from both sides of the main unit, as shown in Figure 3-3.
Protection foam
Figure 3-3 Remove the protection foam of the main unit
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4. Remove the plastic bag from the main unit. Grab the bottom of the main unit and lift it onto a countertop.
Note that the main unit must be lifted by one to two persons, as shown in Figure 2-4.
Figure 2-4 Lift the main unit
14.3.3 Checking Packing List
Check the delivered components against the packing list to see if everything is delivered, as shown in Figure
2-5.
Packing List
Figure 2-5 Packing List
Note
While moving the instrument, keep it as level as possible and avoid strong impact!
Always lift the left and right side of the main unit to move it, as lifting the front of the analyzer may
damage the front cover.
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14.4 Connections
1. See Figures 2-6 and 2-7 for connections of reagents and the waste container. The lyses are placed inside
the left door of the analyzer, and the diluent and the waste container should be placed under the desktop.
Diluent
Waste liquid
Figure 2-6 Back of the instrument Connections of reagent and waste containers
Lyse
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Figure 2-7 Left side of the instrument Connection of lyse container
Note
Remove the plug from the fluidics interface on the back of the instrument.
Make sure that the lyses are placed at the same level as the analyzer, and that the connector of the cap
assembly is not damaged.
Make sure that the lengths of the diluent and waste tubes used do not exceed 1500 mm.
The top height of the waste container and diluent container should be lower than the desktop of the
instrument.
2. Connect the tubes according to the colors of the connectors, and open the left door to connect the lyse
inlets. See Figure 2-8 and Figure 2-9.
. Note that the tube connectors and their counterparts on the analyzer shall be of the same colors.
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Lyse inlet
Figure 2-9 Properly connected tubes
After connecting the reagents, tighten the cap assembly to avoid leakage and then close the left door.
3. Connect the network cable to the specified interface, as shown in Figure 2-10. Connect the printer through
the USB ports. Supported printer models include: EPSON LQ-590K, HP Laser Jet P1505n, HP OfficeJet Pro
K5300, and HP LaserJet P1606dn.
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Figure 2-10 USB port and network port
14.5 Startup and Setup
14.5.1 Initial Start-up
Start the main unit:
1. Set the “O / I” power switch on the back of the main unit to “I”. The power switch will be on.
2. Verify that the indicator on the main unit is on.
3. The system automatically performs the self-test procedure and initializes the system. Enter the correct
username (service) and password (Se s700) in the login dialog box, as shown in Figure 2-11.
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Figure 2-11 Login
Note
The first time the power is turned on, the reagents have not been set, and there will be alarms indicating
that “Diluent ran out” and “Lyse ran out”.
14.5.2 Reagent Setup
1. Click the “Reagent Management” button in the status bar at the top of the main screen to enter the
following screen, as shown in Figure 2-12.
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Figure 2-12 Reagent Management
2. According to the actual reagents used, set and replace “Diluent” and “Lyse” using the barcode scanner or
the number below the barcode.
14.5.3 Maintenance Setup
1. Click "Setup" - "Maintenance Setup" in the system menu.
2. According to the customer's demand, set up the waiting time before entering standby mode automatically,
which means for how long the analyzer stays inactive, it will enter the standby mode automatically.
3. According to the customer's demand, set the start time of the probe cleanser maintenance. If the time for
probe cleanser maintenance should be set, enter it in the daily maintenance time edit box. As shown in
Figure 2-13:
Note
Default settings are recommended.
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Figure 2-13 Maintenance settings
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14.5.4 Other Function Verification
Click Menu - "Setup" — "System Setup" - "Print Setup" to enter the "Print" screen.
The print button is highlighted, indicating that the printer is successfully connected, which can print reports,
as shown in Figure 2-14.
Print Button
Figure 2-14
4.Print Setup screen
14.5.5 Verification of External Barcode Scanning
If the customer requires an external barcode scanner, plug the connector of the scanner into the USB port of
the PC as shown in Figure 2-15. It can be used for reagent barcode scanning and sample ID barcode
scanning.
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Figure 2-15 Connecting the external scanner
14.6 Performance Test
14.6.1 Background Verification
Test the background results of the analyzer, make sure the results meet the requirement of the analyzer
specification. Note: Aspirate the diluent in the tube for background test. The background requirements are as
follows:
Table 2-3 Background/blank count requirements
Parameter
Background/blank count requirements
≤0.20
WBC
RBC
HGB
HCT
≤0.02
≤1
≤0.5
≤5
PLT
Steps
1. Click “Menu”- "Performance" - "Background" in the system menu, as shown in Figure 2-16.
Figure 2-16 Entering the "Background" screen
2. Click the “Mode” button at the bottom to switch the blood sample analysis mode directly.
3. Take diluent as a sample and test it on the analyzer for 3 times continuously under the needed mode. The
highest result of the three measurement is taken as the blank count results.
4. When the test finishes, the analyzer will evaluate the background results and report Pass or Fail at the
bottom of the screen, as shown in Figure 2-17.
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Figure 2-17 Calculating the "Background" measurement results
5. When tests complete, click “Export” to export the background data into a USB drive. “Export succeeded” is
displayed, as shown in Figure 2-18.
Figure 2-18 Exporting measurement results
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14.6.2 Repeatability Test
Introduction
Test the repeatability of the analyzer using fresh blood samples or controls, and make sure the repeatability
meets the requirement of the analyzer specification. The repeatability specifications of the analyzer are
shown in Table 2-4:
Table 2-4 Repeatability Requirements
Parameter
Condition
7.0 - 15.0  109 / L
Whole
Blood Predilute Repeatability
Repeatability
(CV/absolute deviation
(CV/absolute
≤2.0
deviation
≤3.5 d)
d)
WBC
4.0 - 6.9  109 / L
RBC
3.50 - 6.50  1012 / L
≤1.5
≤4.0
HGB
100~180 g/L
≤1.5
≤2.0
MCV
70.0~110.0 fL
≤0.5
≤2.0
150 - 500  109 / L
≤4.0
100-149 109 / L
≤5.0
PLT
Lymph%
Lymph%≥15%
WBC≥4.0×109/L
Mid%
Mid%≥5%
WBC≥4.0×109/L
Gran%
Gran%≥30%
WBC≥4.0×109/L
CV%
≤1.5
≤ 12%
≤ 12%
≤ 25%
≤ 25%
≤ 12%
≤ 12%
RDW-CV
-
≤ 3.5%
≤ 3.5%
RDW-SD
-
≤ 3.5%
≤ 3.5%
MPV
-
≤ 4.0%
≤ 5.0%
30-50%
HCT
≤2.5
Steps
I. Whole Blood Repeatability Measurement
1. Click "Menu → Performance → Repeatability" to enter the repeatability test screen. As shown in Figure
2-19:
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Figure 2-19 Repeatability test
2. Click the “Mode” button to select the repeatability test mode: Whole Blood, as shown in Figure 2-20.
Figure 2-20 Mode selection
3. Take a control as an example. Enter the lot No. of the control in the blank of the lot No.
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4. Start the test according to the normal method of sample counting. Press the “Aspirate” key and measure
the normal level control consecutively for 10 times, as shown in Figure 2-21.
Figure 2-21 Pressing the “Aspirate” key
5. After the measurement completes, select the test data in the selected field. The instrument will
automatically display whether the repeatability is passed at the right bottom, as shown in Figure 2-22.
Figure 2-22 Repeatability test
6. If you want to check the specific repeatability information, click the “Statistics” button at the bottom of the
screen, and the screen shown in Figure 2-23 will pop up.
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Figure 2-23 Statistics
14.6.3 Accuracy Verification
Introduction: Verify the accuracy of the instrument results with matching calibrators or fresh
blood. Steps are as follows:
Matching Calibrator
1) After removing the calibrator from the refrigerator (2-8 °C), leave it at room temperature
(18-25 °C) for 15 minutes, and make its temperature recover to room temperature.
2) Check if the calibrator is out of service and if it is deteriorated or contaminated.
3) Please refer to the calibrator instruction manual for the mixing method of the calibrator.
4) When opening the stopper, put on gauze or soft paper to absorb the spilled blood.
Fresh Blood Calibrator
1) Use the evacuated collection tubes with EDTA·K2 as anticoagulant (1.5-2.2 mg of
anticoagulant needed for 1 ml blood) to take 2.5 ml of fresh blood from each of 3-5 healthy
subjects. The HGB, WBC, RBC, MCV and Plt test results of fresh blood should be within the
reference range
(Table 7.2 Range of repeatability requirements) Each sample is treated as follows.
2) Continuously test the sample for 5-10 times with laboratory-approved or calibrated
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instrument, and calculate the average value of the test results, which is taken as the value of
fresh blood.
Calibration Process
Step 1: Calibrate the calibrator
1) Select “Calibration” > “Calibrator Calibration” from the drop-down menu to enter the screen
as shown below.
2) Perform calibration according to section 8.3.3 Calibrator Calibration in the Instruction for
Use.
3) Confirm calibration results:
After 10 consecutive tests, the instrument will automatically calculate the average values,
standard deviations and CV values of the WBC, RBC, HGB, MCV and PLT parameters. The
system automatically determines whether the calibration is successful. If successful, save the
new calibration coefficient. If it is unsuccessful, please re-check the performance after the
maintenance personnel service the instrument.
Step 2: Calibrate fresh blood
1) Select “Calibration” > “Fresh Blood Calibration” from the drop-down menu to enter the
screen as shown below:
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2) Perform calibration according to section 8.3.4 Fresh Blood Calibration in Instruction for
Use.
3) Confirm calibration results
After 10 consecutive tests, the instrument will automatically calculate the average values,
standard deviations and CV values of the WBC, RBC, HGB, MCV and PLT parameters. The
system automatically determines whether the calibration is successful. If successful, save the
new calibration coefficient. If it is unsuccessful, please re-check the performance after the
maintenance personnel service the instrument.
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15 Setup of Data Transmission and LIS
Connection
15.1 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
15.1.1 Network Communication
Figure 15-1 Communication Setup screen
⚫
Network Types
Network type: supports both "Wireless" and "Wired" devices.
◼
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Wired network: Set the
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protocol only;
◼
inserting
Wireless network: After
the
wireless
adapter, click the
the
right
side
following
figure
network
buttons on
of
the
option.
The
is displayed.
Select a connected Wi-Fi network,
and click the “Connect” button to
connect to the Wi-Fi network.
Figure 15-2 WiFi connection setup
Recommended network card models:
◼
NETGEAR: WNA3100M;
◼
EDUP：EP-N8508GS.
⚫
Protocol Setup
IP Address:
Setup the IP for the hematology analyzer; 10.0.0.2 by default
Subnet mask:
Subnet mask for the hematology analyzer network; use 255.255.255.0 for most cases
Default gateway:
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Gateway IP
Mac address:
The Mac address of the analyzer is fixed by manufacturer and cannot be changed.
◼
Communication protocol:
Tap the pull down list to select a suitable communication protocol.
◼
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.
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.
15.1.2 Serial Interface Communication
The 3008 serial interface communication uses the USB-serial method. Ensure the USB-serial
cable is properly connected before setup.
⚫
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Figure 15-3 Serial communication setup screen
⚫
Protocol Setup
Baud rate: the transmission rate for serial communication; 19200 by default;
Check Bit: parity bit, empty by default;
Data Bit: 8 by default;
Stop Bit: 1 by default;
Comm Protocol: support HL7, 8ID and 10ID serial communication protocols
15.1.3 Transmission Mode
The operator can activate the relevant communication settings by ticking the desired options
in the checkboxes as needed:
⚫
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 Communication
When the option is selected, software will automatically send the sample information and
analysis results to the LIS.
⚫
Transmitted
as
print
bitmap data
When the option is selected, the histograms will be sent to LIS as printed data with white
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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.
⚫
Transmitted as bitmap
When this option is selected, the histograms will be transmitted in the format of bitmap to
LIS.
⚫
Transmitted as 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
15.2 Setup of Data Management Software
15.2.1 Communication Parameter Setup
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Figure 15-4 Communication Parameter Setup screen on Data Management Software
Referring to the figure above, fill in the IP address with that of the hematology analyzer.
10.0.0.2 by default. The port is fixed at 5100 and the protocol type matches the settings of the
hematology analyzer.
15.2.2 Communication Instrument Management
Figure 15-5 Communication Instrument Management screen on 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.
15.3 Troubleshooting for Communication Errors
⚫
Physical connection
Check whether the network cable is properly connected; and whether the network physical
connection is correct.
⚫
Communication
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.
15.4 LIS Connection Configuration
The analyzer can connect to the LIS normally and the LIS can print qualified test reports,
which is one of the most important symbols showing that the analyzer is officially put into
service. Engineers should pay enough attention and work with LIS engineers to complete the
LIS connection work. To enable engineers to effectively cooperate with LIS engineers to
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complete LIS connection, the following describes basic work content of LIS connection and
common LIS problems. This chapter contains communication parameter setup of LIS and
instrument software, as well as sample analysis and result transmission when an LIS is
connected.
15.4.1 Network Setup
The PC of the analyzer communicates with the LIS via TCP/IP. They transfer data through
network ports according to HL7 protocol format. Network setup is the first step of LIS
connection.
The stability of the network is very important for LIS communication. The computer connected
to the instrument generally contains 2 network adapters. One IP address of the network
adapter is set in the same network as that of the instrument, and the IP address of the other
network adapter should be set to the same network as LIS.
The instrument workstation computer should communicate with the instrument and the LIS
system simultaneously to establish an effective LIS connection.
15.4.1.1 Viewing Network Adapter Status
Checking the installation status of the network adapter driver is an important part of checking
the network status. If the network adapter driver is not installed or the installed driver is
abnormal, network communication will fail even if the network ports and network cable are in
good condition.
Rigth-click My Computer and choose Properties from the shortcut menu. Click Device
Manager, expand Network adapters(s), and check the installation status of the network
adapter driver to check the network adapter status.
Right-click My Computer and
choose Properties from the
shortcut menu. Click Device
Manager
Network
and
expand
adapters(s).
Expand network adapters to
check the installation status of
the network adapter driver.
15.4.1.2 PING Command:
Ping is also a communication protocol and is a part of TCP/IP. Run the ping command
to check the network connectivity, so as to analyze and judge network errors. Format
of the ping command: ping IP address. Run the ping command to test the network status.
1. Press Win+R and enter cmd.
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2.
3. Run the Ping + IP address command. If the ping operation is successful, the network
is reachable.
15.4.2 Communication Parameter Setup
Mindray equipment strictly follows the HL7 protocol electronic data interaction standard.
Each message header and separation field defined by the HL7 protocol standard store
corresponding data. The LIS engineer should develop the LIS interface in conjunction with
the communication protocol.
Note: During the LIS communication process, the instrument acts as the server and the LIS
interface program acts as the client. The port ID is fixed at 5100. The (instrument) server
must be turned on first, and then the LIS system (client) is turned on. In this way, the LIS
communication can be established. If the LIS system is turned on first and the instrument is
turned on later, the LIS communication will not be established.
When the instrument does not send the test result to the LIS, it will send the heartbeat
character 0x02 to the LIS system every few seconds.
15.4.2.1 Protocol Setup
The instrument supports information interaction with the LIS system using the HL7 standard.
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At present, the HL7 protocol is widely used at home and abroad.
Setup ->System Setup ->Communication Setup Enter the Communication Setup screen.
15.4.2.2 ACK Synchronous Transmission
Ticking the ACK synchronization communication flag will enable control. After the ACK is
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enabled, the instrument will detect whether the corresponding response is received when
sending the result of the specimen detection. The instrument must wait for the correct
response returned by LIS each time a result is sent. If there is no response or a response is
wrong, communication will be blocked. In particular, note that for this instrument, failure to
respond or a response error during LIS communication may result in a black screen on the
instrument.
It is recommended to tick ACK, ACK
response to make LIS communication
more stable and reliable.
15.4.2.3 Port ID
Port ID 5100 is a fixed port for communication with the LIS interface. Although the port ID
cannot be set on the instrument screen, the LIS interface must use port 5100 to establish a
LIS connection with the instrument.
15.4.2.4 Client Mode
The instrument acts as the server and the LIS interface acts as the client mode to participate
in the LIS communication . If the LIS acts as a server to communicate with the instrument,
network failure will be reported. To be precise, this error is a network error caused by a mode
error.
15.4.2.5 Auto Communication
Auto communication means real-time communication. After the engineer develops the LIS
interface, the most common communication method used by the instrument is auto
communication. The instrument automatically sends the results to the LIS system without
manual intervention. Real-time transmission requires that the LIS connection is always online,
and communication fails if the LIS connection is disconnected.
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Auto communication means real-time communication, and the
results are automatically sent to LIS after the specimens are
detected.
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In the Review screen, you can manually select the sample(s)
individually or in batches. The color of the selected sample will change.
Then select the communication button at the bottom to manually send
the results to the LIS system. Manually sending the test results of the
specimen is no different from sending the test result of the same human
specimen in real time.
15.4.2.6 Manual Communication
In the Review screen, manually select the sample and send the result to LIS. Manual
communication generally appears in the following scenario. In the early stage of LIS interface
development, LIS engineers should receive the raw data of the instrument for development
needs, and most of them would not use the actual specimen on the instrument during
operation.
For LIS engineers, they only care about the original data of the instrument. There is no
difference between manual communication and real-time communication. In another case,
the doctors in the department may perform manual communication, because occasionally the
instrument is disconnected from LIS.
15.4.2.7 Batch Transmission:
Select multiple specimens in the Review screen and click Communication. In fact, batch
transmission is not different from manual transmission. There is only a difference in quantity,
single data communication sends the result of a person, and batch transmission sends the
results of multiple samples at a time.
15.4.3 Common LIS Errors
15.4.3.1 LIS problem after ACK ticked
ACK has the function of flow control to alleviate the data processing pressure of the
LIS system. Proper use of ACK can reduce a lot of unnecessary trouble. Ticking ACK means
that the LIS should give a response and the response should be correct. If no response
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or the response is incorrect, the following situations will occur. Before ticking the
ACK, first check whether the LIS system has the ACK response function through the LIS
log, whether the response format is correct, and whether it responds within the
specified time.
1. The instrument suddenly displays black screen after the LIS communication process
2.
Sending sample results failed
Message ID is the key to
ACK response
Message
ID
Message ID is the key to
should
be
ACK response
consistent
Response
message
event
ACK
<0x0B>MSH|^~\&|BC-6800|Mindray|||20180914164146||ACK^R01|354|P|2.3.1||||||UNICODE<
0x0D>
MSA|AA|354<0x1C><0x0D>
2018-09-14 16:41:46.242 Finish Receive Data
15.4.3.2 Alarm Information Processing
The LIS system needs to obtain the alarm information on the instrument screen. In fact, the
instrument has sent the alarm information on the screen to the LIS system at the same time
as LIS communication. The alarm information is sent to the LIS system in the form of alarm
code instead of the Chinese alarm content. The LIS interface should establish an alarm
dictionary library in advance, and then match the alarm codes on the instrument screen. The
alarms are then displayed on the LIS system screen to prompt the laboratory operator.
The alarm
informatio
n
is
transmitte
d to LIS in
the
form
of
alarm
code. The
LIS
system
should
maintain
LIS needs an alarm ID to match the alarm name. For example, if the original data sent to the
the alarm
No.: HXQ-19001-New 3-DIFF
dictionary
informatio
n
according
Version: 1.0
IVD Global Technical Support Dept.
LIS is 1200, LIS should process it as that this is an alarm Flag, and the alarm name is WBC
Scattergram Abn. For the establishment of the alarm dictionary, refer to the communication
manual.
15.4.3.3 Image Reverse Color Processing:
The LIS engineer fed back that the bitmap data transmitted by the instrument is black
background when converted into an image. This problem can be solved in the LIS interface or
in the setup of communication parameters. The bitmap data can be transmitted as print
bitmap.
The
bitmap
data
can
be
transmitted as print bitmap. The
LIS
interface
does
not
reverse color processing.
As long as this parameter is ticked, the image generated by the LIS interface is white
background instead of black background.
Bitmap data problems can be deepened with tools.
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Version: 1.0
need
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15.4.3.4 Mode Problem
In the LIS communication process, the instrument participates in LIS communication as a
server mode. The instrument is fixed as a server mode, and the mode cannot be changed.
The corresponding LIS interface is the client mode. The server can only establish LIS
communication with the client.
Scenario 1: The IP address of the LIS computer is the same network as that of the instrument,
and they can be pinged. However, they fail to establish a communication, because the LIS
engineer does not know that the instrument should act as a server. The LIS engineer uses
the interface of the server to establish LIS communication with the instrument.
Communication failure occurs. In another case, the LIS engineer does not know the port ID of
the instrument. If the LIS connection is not established successfully, the communication will
fail.
Scenario 2: The LIS computer acts as a client and boots up earlier than the instrument every
day. In this case, it is actually impossible to establish a valid LIS connection. When the
instrument starts to detect the result, the result will not be automatically sent to the LIS
system, because the instrument is not started as the server, the client cannot establish the
LIS connection.
15.4.3.5 Start and End Characters Problems
The start and end characters mentioned in the Mindray communication document refer to
those in the ASCII table, which are expressed as hexadecimal, 0x0B, 0x1C, and 0xOD
15.4.4 User Guide to Bidirectional Test Tool
Steps of Using the Test Tool
I. Double-click Mindray.exe.
Note: The bidirectional test checkbox is ticked by default and the mode is set to server mode
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by default. Tick the bidirectional test tool to have the function of bidirectional test.
Normally click the server. It will be displayed in red. The tool (LIS interface)
is generally connected to the instrument workstation computer as a server.
You cannot open two identical port services on the same computer at the
same time. One port basically corresponds to one service. When the tool is
used as a server, do not enter an IP address.
II. Set the port ID and IP address.
The port ID and IP address are important parameters to the simulation of
bidirectional LIS communication.
Note: Click Log. Logs will be generated. The logs are stored in D:\Mindray.txt. Raw
data will be cleared when Clear is clicked.
The most critical factor in the communication between the instrument working computer
and the LIS interface is to set the port ID and IP address, and set the appropriate mode to
establish the LIS communication connection. The tool also can be set as the client mode.
No matter the tool is the server or the client mode, it can achieve visualized bidirectional
LIS communication with the instrument.
Set the Port ID:
The DMU&LabXpert port ID should be the same as the Port ID of the Mindray.exe
bidirectional LIS test tool.
Set the IP address:
The IP is set to point to the LIS IP. If the LIS and DMU&LabXpert are installed on one
computer, the IP address can be set to Local IP address (127.0.0.1). If the LIS is not installed
on the same PC of the DMU&LabXpert, the IP address is the distance IP address.
III. Set the basic information of MRsettings.ini.
MRsettings.ini is a simulation bi-directional LIS communication information interaction
window for DMU&LabXpert. Engineers can enter information under this file, and then send
the corresponding basic information to DMU&LabXpert during the bi-directional LIS test.
No.: HXQ-19001-New 3-DIFF
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The
information
personal
maintained
information
in
the
section
is
uploaded to the clinical information
section on the LabXpert or DMU.
TestMode is very important in the bidirectional LIS information interaction, such as the
smear mark: SMST. After receiving the request from the instrument, the tool reads the
contents of the configuration file and sends it to the instrument according to a certain
organization. Especially in a bidirectional LIS communication interaction, the tool does
not read this configuration file during one-way LIS communication.
Remarks:
By default, the tool has a default assignment during programming. Even if the MRsettings.ini
information is not set, the instrument can also implement the function of simulating
bidirectional LIS communication.
15.4.5 User Guide to Data Parsing Tool
From the user guide to the data parsing tool, you can better understand the work of LIS
interface engineers.
so as to effectively work with them to complete LIS interface development. This tool is mainly
to process bitmap data and parse raw data of the instrument.
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When you click the text parsing and parsing button, the raw data in the
text box will be parsed into a clear and concise result set according to a
certain data structure. Bitmap to data or data to bitmap are designed to let
you understand the most complicated work of LIS interface parsing in a
simple way.
When there is any doubt about the raw data of the instrument, it can be copied to the data
parsing tool in combination with the raw data of the instrument. After parsed, the data can be
compared with the results on the instrument.
Click
the
button to trigger
parsing.
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When you click parsing, the tool will perform the data parsing work and record the operation
log for reference.
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16Disassembly and Installation
16.1 Tools
You may need following tools to disassemble and replace mechanical components:
◼
◼
◼
◼
◼
◼
Cross-headed screwdriver (107)
Flat-head screwdriver
Tweezers
Nipper pliers
cutting nippers
Hexagon spanner (1 suite)
16.2 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 mucosa. Wear proper personal protective
instrument (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, and 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 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.
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16.3 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.
⚫
⚫
16.3.1 Remove the Left Door Assembly
Place the analyzer on a flat desktop. Remove the three M3×8 screws, and push the left door
assembly a little towards the rear of the analyzer. Open the left door assembly for about 40cm.
Then unplug the connector of recorder cable, and remove the left door assembly (see below).
16.3.2 Remove the Main Control Board
1.
Follow the instruction in section 8.4.1 to remove the left door;
2.
Remove the SD card;
3.
Remove the four M3×8 screws to disassemble the upper signal shielding cover
(as shown below);
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4.
Unplug all the cables connecting to the main control board, and remove the
nine M3×8 screws. Then take out the main control board (as shown below).
5.
Remove the two M3×8 screws to disassemble the lower signal shielding cover
(as shown below);
Installation:
Install the assembly in the reversed order of the disassembly steps.
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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.
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.
16.3.3 Remove the right door
Place the analyzer on a flat desktop (as shown below). Remove the three M3×8 screws
fixing the right door (at the rear of the analyzer) to remove the right side plate.
16.3.4 Remove the RBC Bath Assembly
1. Follow steps 1 and 2 in section 16.3.2 to remove the upper signal shielding cover and
unplug the connector of the signal cable;
2. Follow the instruction in section 16.3.3 to remove the right door;
3. Remove the four M3×8 screws to disassemble the shielding box (as shown below);
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4. As shown below, remove all the tubes below the bath, and take out the two M3 screws
fixing the counting bath module as well as the grounding M3X8 screw. Remove the
counting bath module.
Installation:
Install the 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
section 0.
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.
Install the aperture sensor as its concave surface facing the center of the RBC bath.
16.3.5 Remove the WBC bath and HGB Light Assembly
1. Follow steps 1 and 2 in section 16.3.4 to remove the shielding box,
2. Follow the instructions in section 16.3.1 to remove the left door assembly and unplug the
connector of HGB unit from the main board.
3. As shown below, remove the two M3 screws fixing the bath cover and take out the lower
part of the WBC bath module. Rotate the HGB light assembly 90°counterclockwise to remove
it.
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Installation:
Install the 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
section 0.
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.
16.3.6 Remove the Preheating Assembly
1. Follow the instruction in section 16.3.3 to remove the right door;
2. As shown below, unplug all the tubes of the preheating assembly and remove the two 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).
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Installation:
Install the 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.
16.3.7 Remove the Right Side Valve Assembly
1. Follow the instruction in section 16.3.3 to remove the right door;
2. As shown below, unplug all the tubes of the valve to be serviced, and remove the two
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).
Installation:
Install the 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.
16.3.8 Remove the Liquid Detection Board PCBA
1. Follow the instruction in section 16.3.3 to remove the right door;
2. Remove the two M3×8 screws and take out the liquid detection board installation box and
PCBA.
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3. Remove the tubes and cables connected to the liquid detection board and take out the
liquid detection board PCBA.
Note: During installation, the PCBA connector at the position marked L should
connect reagent tube, the other connector should connect diluent tube.
16.3.9 Remove the Waste Pump
1. Follow the instruction in section 16.3.3 to remove the right door;
2. As shown below, unplug all the tubes of the pump to be serviced, and remove the four
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 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
section 0.
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16.3.10
Remove the Air Pump
1. Follow the instruction in section 16.3.3 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 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
section 0.
16.3.11
Remove the Vacuum Chamber Assembly
1. Follow the instruction in section 16.3.3 to remove the right door;
2. Unplug the tubes connected to the vacuum chamber and remove the two M3×8 screws to
take out the vacuum chamber assembly.
Installation:
Install the assembly in the reversed order of the disassembly steps.
Verification:
1.
Check whether all the parts and components are properly installed and fixed;
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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.
4.
For the debugging and verification information of a certain component, refer to
section 0.
16.3.12
Remove the Diluent Temperature Sensor
1. Follow the instruction in section 16.3.3 to remove the right door;
2. Unplug all the cable connectors and tubes connected the temperature sensor.
Installation:
Install the assembly 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.
16.3.13
Remove the Top Cover
As shown below, remove the two M3×8 screws and lift up the top cover from the rear edges of
the analyzer to remove the cover.
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16.3.14
Remove the Aspiration Module
1. Follow the instruction in section 16.3.3 to remove the right door;
2. Follow the instructions in 16.3.13 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 of the sample probe and remove the four M3×12 screws
as well as the washers. Then lift up the aspiration module to remove it.
Installation:
Install the 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.
Select "Service" → "Sample Probe Debug" to debug and confirm the home position
of the sample probe and the up, middle and down positions of the WBC and RBC
baths, so as to ensure the reliable operation of sample probe.
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4.
For the debugging and verification information of a certain component, refer to
section 0.
16.3.15 Remove the Motor
Assembly of Aspiration Module
Horizontal
Photocoupler
1. Follow the instruction in section 16.3.14 to remove the aspiration module;
2. Remove the four M3×4 screws to disassemble the optical coupler assembly (as shown
below);
Installation:
Install the 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" → "Home position" to return the sample
probe to the home 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
section 0.
16.3.16
Replace the Sample Probe
1. Power on the analyzer and tap the "
" button to enter the system menu. Select "Service"
→ "Sample Probe Debug", and then tap "Home position" to make the sample probe move to
above the WBC bath;
2. Follow the instruction in section 16.3.4 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.
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Installation:
Install the assembly in the reversed order of the disassembly steps.
For the debug method of sample probe position, refer to section 20.2.
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 and confirm the home position
of the sample probe and the up, middle and down positions of the 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
section 0.
16.3.17
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 "Home position" to make the sample probe move to
above the WBC bath;
2. Follow the steps of section 16.3.18 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.
Installation:
Install the assembly in the reversed order of the disassembly steps. Follow the instruction
of 16.3.17 to adjust the sample probe positions.
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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 and confirm the home position
of the sample probe and the up, middle and down positions of the 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 form the bottom of the sample wipe.
4.
For the debugging and verification information of a certain component, refer to
section 0.
16.3.18 Remove the Aspiration Module Photocoupler in
Vertical Direction
1. Follow the instructions in 16.3.13 to remove the top cover. Unplug the cable connectors of
the optical coupler assembly of aspiration module motor.
2. Follow the instruction in section 16.3.3 to remove the right side plate;
3. Push 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.
4. Push the sample probe to the front aspiration position (As shown below) and remove the
M3×4 screw. Pull down and remove the optical coupler assembly from the front side.
Installation:
Install the 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" → "Home position" to return the sample
probe to the home 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
section 0.
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16.3.19
Remove the Front Cover Assembly
1. Place the analyzer on a flat desktop.
2. Follow the instruction in section 16.3.1 to remove the left door assembly and remove the
cables of front cover assembly from the main control board;
3. Follow the instruction in section 16.3.3 to remove the right door;
4. Follow the instruction in section 16.3.13 to remove the top cover;
5. Remove the six 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.
16.3.20
Remove the Indicator PCBA
1. Follow the instructions in 16.3.21 to remove the front cover assembly and place it on a flat
desktop. Unplug the cable connector to the indicator terminal.
2. Remove the two M3×10 screws (as shown below), and then remove the indicator board
shield and the indicator board PCBA.
Installation:
Install the 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. Power on the analyzer and make sure the status indicator light on.
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16.3.21
Remove the Touch Screen Control Board
1. Follow the instructions in 16.3.21 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 two 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 two M3×8 screws. Then
take out the touch screen control board (as shown below).
Installation:
Install the 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 touch screen works properly.
16.3.22
Remove the Touch Screen Assembly
1. Follow steps 1 and 2 in 16.3.23 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 four M3×8 screws fixing the screen assembly, take out the
screen assembly and unplug all the cables connected to the screen.
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Installation:
Install the 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.
16.3.23
Remove the Touch Screen
1. Follow steps 1 and 2 in 16.3.23 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 four M3×8 screws fixing the screen assembly, take out the
screen assembly (Do not unplug the cables).
3. Remove the touch screen from the front cover.
Installation:
Install the assembly 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.
Screen Cal.
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4.
16.3.24
Start the analyzer and check whether the touch screen works properly.
Remove the Micro-switch Assembly
1. Follow the instructions in 16.3.21 to remove the front cover assembly and place it on a flat
desktop. Unplug the micro-switch from the main control board.
2. Remove the two M3×4 screws to disassemble the start key and its supporting board (as
shown below);
3. As shown below, remove the two M3×8 screws, and take out the micro-switch assembly
from the little hole on the front plate.
Installation:
Install the 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.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
16.3.25
Remove the Syringe
1. Follow the instructions in 16.3.21 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 four M3×12 screws as well as the washers, remove the
syringe assembly and unplug the cable connected to the syringe.
4. Remove the three M3×8 screws and the tailored screw to disassemble the syringe (as
shown below).
Installation:
Install the 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 and tubes are correctly connected;
3.
For the debugging and verification information of a certain component, refer to
section 21.
16.3.26
Remove the Syringe Motor
1. Follow step 1 to 3 in 16.3.27 to remove the syringe assembly;
2. As shown below, remove the two M3×12 inner hexagon screws fixing the shaft connector,
and then remove the four M3×12 inner hexagon screws fixing the motor. Remove the motor.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Installation:
Install the 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 and tubes are correctly connected;
3.
For the debugging and verification information of a certain component, refer to
section 21.
16.3.27 Remove the Syringe Motor Position Photocoupler
Assembly
1. Follow step 1 to 3 in 16.3.27 to remove the syringe assembly;
2. As shown below, remove the two M3×6 inner hexagon screws fixing the shaft connector,
and then remove the motor position optical coupler assembly.
Installation:
Install the 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 and tubes are correctly connected;
3.
For the debugging and verification information of a certain component, refer to
section 0.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
16.3.28
Replace the RBC/WBC Isolation Chamber Filter
1. Follow the step 1 and step 3 in section 16.3.4 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.
Installation:
Install the 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 are correctly connected.
16.3.29
Replace the Power Unit
1. Follow the instruction in section 16.3.13 to remove the top cover;
2. Remove all the cable connectors on the top of the power unit;
3. As shown below, remove the five M4×8 screws and pull out the power unit for a certain
length. Remove the ground screw on the left side.
Installation:
Install the assembly in the reversed order of the disassembly steps.
Verification:
1.
Check whether all the parts and components are properly installed and fixed;
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
2.
16.3.30
Ensure the cables are correctly connected;
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 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.
Try the print function and make sure the printer work normally.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17 Assembly Exploded Views
17.1 Overview
This section shows the diagram and part number for each assembly. Such information
can help engineer order and change the parts.
NOTE
All the part numbers in the tables below are intended for engineer to query the order number.
When you order spare parts, please use the order number in the spare parts list from Mindray.
If the part number is shown as /, that means the part cannot be ordered as a spare part. It is
intended to help reader understand the machine.
Tube or connectors are not mention in this section. Please refer to the liquid system section.
17.2 Instrument Panels
No.
Part Number
Name
Quantity
Remark
1
/
Left-side Panel
1
/
2
/
Front Panel Assembly
1
/
3
/
Right-side Panel
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
No.
Part Number
Name
Quantity
Remark
4
/
Top Cover
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.3 Front Side
17.3.1 8.4”
LCD
Front
BC-10&10e&11&20s&21s)
No.
Part Number
Panel
Name
Assembly
Quantity
(for
Remark
Front Panel
1
2
8” screen trim strip, short
2
3
8” screen trim strip, long
2
4
021-000271-00
Touch panel resistive 8.4
inch 4-wires
1
5+6+7
115-039856-00
LCD assembly (8.4")
1
6
051-000881-00
Touch screen control PCBA
1
7
042-019131-00
Shielding box
1
17.3.2 10.4”
LCD
Front
BC-20&21&30&31&30s&31s)
No.: HXQ-19001-New 3-DIFF
Panel
For
BC-10&10e&11&20s&21s
Assembly
Version: 1.0
(for
IVD Global Technical Support Dept.
1
No.
Part Number
1
2
3
4
Name
5
6
Quantity
7
Remark
Front Panel
2
047-016363-00
10” screen trim strip,
short
2
3
047-016362-00
10” screen trim strip,
long
2
4
021-000279-00
Touch panel resistive
10 inch 4-wires
1
5+6+7
115-025652-00
LCD assembly (10")
1
6
051-000881-00
Touch screen control
PCBA
1
7
042-019131-00
Shielding box
1
No.: HXQ-19001-New 3-DIFF
For
BC-20&21&30&31&30s&31s
Version: 1.0
IVD Global Technical Support Dept.
17.3.3 Front Panel Assembly Back View
1
No.
Part Number
Name
Quantity
Remark
1
051-001857-00
3008 indicate board PCBA
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.3.4 Components on The Front Frame
No.
Part Number
Name
Quantity
Remark
1
115-025639-00
Syringe assembly
1
/
2
042-027570-00
Probe wipe block stop plate
1
/
3
043-005810-00
[Aspirate] key (BC-20S)
1
/
4
115-025647-00
[Aspirate] key assembly
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.3.4.1 Syringe Assembly
No.
Part Number
Name
Quantity
Remark
1
801-3003-00027-00
Mindray Syringe
assembly.10Ml
1
/
2
115-027479-00
250ul syringe (with nozzle)
1
/
3
041-005167-00
Screws
2
/
4
2800-21-28878
Rotation Motor Position
Sensor Assembly
1
/
5
024-000366-00
Motor Step, 3.6V 1.8
degree/step, 0.53Nm
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.3.4.2 [Aspirate] key Assembly
No.
Part Number
Name
Quantity
Remark
1
801-3007-00014-00
3007 switch(FRU)
1
Includes the wire
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4 Right Side
17.4.1 Sampling Assembly Position
No.
Part Number
Name
Quantity
Remark
1
115-062178-00
Sampling assembly
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.1.1 Sampling Assembly
1
2
5
3
4
1
No.
Part Number
Name
Quantity
Remark
1
3001-10-18516
Step motor, 5.61V 1.8
degree/step 0.32Nm
1
/
2
801-3001-00055-00
Sensor assembly
1
/
3
801-3003-00015-00
Rotation motor position
sensor assembly
1
/
4
801-1805-00004-00
Sample probe wipe
block
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
No.
Part Number
Name
Quantity
Remark
5
801-1805-00003-00
Sample probe
1
OD2.5mmID0.65mm
AISI 316L
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.2 Valves and Temperature Sensor
No.
Part Number
Name
Quantity
Remark
1
801-3201-00002-00
2-way valve (Mindray)
2
SV03 (exists on
BC-20s&21s&30&31&30s&31s),
SV04
2
801-3201-00003-00
3-way valve (Mindray)
6
SV01, SV05~SV09
3
115-015677-00
Diluent temperature
detecting assembly
1
/
4
115-015967-00
SMC 3-way valve
1
SV02
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.3 Counting Bath (For BC-20s&21s&30&31&30s&31s)
No.
Part Number
Name
Quantity
1
115-025645-00
WBC Bath Assembly
1
2
115-025644-00
RBC Bath Assembly
1
3
042-011528-00
Shielding Box
1
4
043-000711-00
Isolation Chamber with Filter
2
For WBC Bath
5
801-1805-00023-00
Isolation Chamber
2
For RBC Bath
Shielding Box Back
1
6
No.: HXQ-19001-New 3-DIFF
Version: 1.0
Remark
For
BC-20s&21s&30&31&30s&31s
IVD Global Technical Support Dept.
17.4.4 Counting Bath (for BC-10&10e&11&20&21)
1
2
3
4
No.
Part Number
Name
Quantity
Remark
1
115-049501-00
Counting Bath Assembly for Single
Channel Model
1
For BC-10&10e&11&20&21
2
042-011528-00
Shielding Box
1
3
043-000711-00
Isolation Chamber with Filter
1
Shielding Box Back
1
4
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.5 WBC Counting Bath Assembly
No.
Part Number
Name
Quantity
Remark
1
/
Bath Cap
1
/
2
/
O ring, 21.2X1.8
1
/
3
115-025640-00
HGB Module
1
/
4
/
Front Bath Washer
2
/
5
/
Rear Bath
1
/
6
/
Aperture
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.6 RBC Counting Bath
No.
Part Number
Name
Quantity
Remark
1
/
RBC Bath Cap
1
/
2
/
O Ring 21.2X1.8
1
/
3
/
Front Bath Washer
2
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
No.
Part Number
Name
Quantity
Remark
4
/
RBC Rear Bath
1
/
5
/
Aperture (D70um)
1
/
17.4.7 Pump
No.
Part Number
Name
Quantity
Remark
1
115-025715-00
Air pump Assembly
1
/
2
115-025643-00
Waste pump Assembly
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.8 Vacuum Chamber and Preheat Assembly
No.
Part Number
Name
Quantity
Remark
1
115-025641-00
Vacuum / Pressure Chamber
1
/
2
115-049623-00
Reagent Pre-heater Assembly
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.9 Reagent
Detector
BC-20s&21s&30s&31s)
Assembly
Position
(For
No.
Part Number
Name
Quantity
Remark
1
115-025642-00
Reagent Detector Assembly
1
/
2
051-001621-00
Liquid Detect Board PCBA
2
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.4.10 Reagent
Detector
BC-20s&21s&30s&31s)
Assembly
(For
1
No.
Part Number
Name
Quantity
Remark
1
051-001621-00
Liquid Detect Board PCBA
2
/
17.5 Left Side Frame
No.
Part Number
Name
Quantity
Remark
1
051-001714-00
Master Board PCBA
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
No.
Part Number
Name
Quantity
Remark
2
M05-010R03---
Lithium battery 3V 35mAh
D12.5*2.0
1
/
3
115-030832-00
SD Card（with software）
1
8GB, MLC, Class10
4
042-005949-00
Bottom Signal Shield
1
/
5
042-005948-00
Top Signal Shield
1
/
17.6 Back Panel and Left Side Panel
2
1
No.
Part Number
Name
Quantity
Remark
1
115-054722-00
Power Box Assembly
1
/
2
801-2800-00016-00
Recorder Module
1
/
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
17.6.1 Power Box Assembly
1
1
1
N
I
你
1
2
1
1
N
I
你
1
No.
Part Number
Name
Quantity
Remark
1
0030-10-13055
Power Socket and Switch
1
Filter power 115/250VAC6A
panel mount /
2
M07-00131F---
FUSE Time-lag 250V 3.15AD5X20
2
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
18 Error Messages and
Troubleshooting
18.1 Troubleshooting
Error
messa
ge
Error
Code
0x010
Main
00101
control
board
error
Syste
m
clock
error
Trigger
Mechanis
m
Related Repair Parts and
Tools
AD
reference
voltage out
of
range 051-001714-00 3008
[2.4, 2.6]V main control board
0x010
00102
EEPROM
data
incorrect
0x010
00201
The
time
indicated
by
the M05-010R03--- Button cell
system
051-001714-00 3008
clock
is main control board
earlier than
2000-01-01
Troubleshooting Guidance
Replace the main control board
1、 Check whether the button cell of the
main control board is installed;
2、 Replace with a new button cell, and
set up the date and time in the setup
screen. Save the settings, shut down
the analyzer and then restart;
3、 If the error still exists after restarting
the analyzer, replace the main control
board.
0x010
00301
Constant
current
source
voltage out
of
range 051-001714-00 3008
[47, 63]V
main control board
Replace the main control board
0x010
00302
115-025646-00 Power box
+12V
assembly 009-004354-00
analog
voltage out DC power cord
of
range
Multimeter
[11, 14]V
1、 Check whether the output of the
power board is normal using a
multimeter. If the output is abnormal,
replace with a new power board;
-12V
analog
voltage out
3、 If the error still exists, replace the
main control board.
Power
Error
0x010
00303
No.: HXQ-19001-New 3-DIFF
2、 Unplug and reconnect the power cord;
Version: 1.0
IVD Global Technical Support Dept.
of
range
[-14, -9]V
0x010
00304
+12V
power
voltage out
of
range
[11, 14]V
0x010
00305
24V power
voltage out
of
range
[20, 30]V
Prehe
at bath
temper 0x010
ature
00401
sensor
error
115-025649-00
heating assembly
Diluent
Temperature
connecting cable
sensor
Preheat
051-001714-00 3008
bath
temperatur main control board
e out of
009-004367-00
range
(0,70) ℃
1、 Go to the status screen and check
whether the error exists;
Multimeter
115-015677-00 Diluent
temperature detection unit
Diluent
temper
0x010
ature
00402
sensor
error
Diluent
051-001714-00 3008
temperatur
main control board
e out of
009-004367-00
range
(0,70) ℃
Temperature
connecting cable
2、 Check the temperature sensor,
connecting cable, and main control
board in turn.
sensor
Multimeter
Syring
0x02n
e
assem n0101
bly
error
Searching
for
the
sensor: Not
inside the
sensor area
after
the
action
is
completed
(after
compensati
on);
115-025639-00
module
Syringe
009-004357-00 Cables
connected to motor optical
coupler
009-004355-00
motor cable
Syringe
1、 Perform syringe self-test to
whether the error still exists;
2、 Check the syringe, syringe assembly,
connecting cables, and main control
board in turn.
801-3003-00027-00 10ml
Mindray syringe (FRU)
No.: HXQ-19001-New 3-DIFF
see
Version: 1.0
IVD Global Technical Support Dept.
0x02n
n0102
Leaving the
sensor
area: Still
inside the
sensor area
after
the
action
is
completed;
0x02n
n0103
Other
errors
0x02n
n0201
Searching
for
the
sensor: Not
inside the
sensor area
after
the
action
is
completed;
Aspirat
ion
modul
e
lift
mecha
0x02n
nism
n0202
error
Leaving the
sensor
area: Still
inside the
sensor area
after
the
action
is
completed;
115-027479-00
Mindray
syringe
connector)
250ul
(with
801-3003-00015-00
Motor position sensor
assembly (FRU)
051-001714-00 3008
main control board
Lubricating grease
009-004356-00
Aspiration motor cable
009-004357-00 Cables
connected to motor optical
coupler
115-025638-00
Aspiration module
801-3001-00055-00
Sensor assembly 1
1、 Perform aspiration module self-test to
see whether the error still exists;
2、 Check the sensor, connecting cables,
main control board, and aspiration
module in turn.
051-001714-00 3008
main control board
Lubricating grease
0x02n
n0203
0x02n
n0301
Aspirat
ion
modul
e
rotary
mecha 0x02n
n0302
nism
error
Other
errors
Current
position
unknown;
009-004356-00
Aspiration motor cable
009-004357-00 Cables
connected to motor optical
Searching
for
the coupler
target
sensor: Not
inside the
sensor area
after
the
115-025638-00
Aspiration module
1、 Perform aspiration module self-test to
see whether the error still exists;
2、 Check the sensor, connecting cables,
main control board, and aspiration
module in turn.
801-3003-00015-00
Motor position sensor
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
action
is
completed;
0x02n
n0303
Diluent 0x030
ran out 00101
0x030
Lyse
ran out 00102
Other
errors
assembly (FRU)
051-001714-00 3008
main control board
Lubricating grease
The
051-001621-00
Liquid
reagent
detection board PCBA
detection
reports no 043-000829-00
Reagent
diluent
detection tube
The
reagent
detection
reports no
diluent
009-004360-00
Liquid
detection board cable
Check related tubes, reagent, reagent
detection tube, liquid detection board,
connecting cables, and main control board
in turn
051-001714-00 3008
main control board
Floater
status:
1.
Check
once
in
startup, and
the status is 115-013091-00 Waste
full;
container cap assembly
Waste
0x040
contai
00101
ner full
Prehe
at bath
temper 0x050
ature
00101
is too
high
2.
Check
for 3 times
when
the
analyzer is
standby,
and
the
results all
show that
the status is
full.
009-004361-00 Floater and
supply key connection line
051-001714-00 3008
main control board
Preheat
115-025649-00
Diluent
bath
heating assembly
temperatur
e
higher 051-001714-00 3008
than 45℃
Check the floater, connecting cable, and
main control board in turn
Check the diluent heating assembly and
main control board in turn
main control board
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Prehe
at bath
temper 0x050
ature
00102
is too
low
Diluent
temper
ature
0x050
goes
beyon 00201
d
higher
limit
Diluent
temper
ature
0x050
goes
beyon 00202
d
lower
limit
Preheat
bath
temperatur
115-025649-00
heating assembly
Diluent
e is 2.0℃ 051-001714-00
3008
lower than main control board
the target 009-004359-00
temperatur cable
e
Diluent
temperatur
e is 45℃
Heater
115-015677-00 Diluent
temperature detection unit
051-001714-00
Check the connecting cable of the heater,
diluent heating assembly, and main
control board in turn
3008
1、 Make sure the ambient temperature
falls
in
the
claimed
running
temperature.
higher than
main control board
limit
2、 Check the diluent temperature
detection unit and main control board
in turn.
Diluent
temperatur
1、 Make sure the ambient temperature
falls
in
the
claimed
running
temperature.
e
is
5℃
115-015677-00 Diluent
temperature detection unit
051-001714-00
3008
lower than
main control board
limit
115-025643-00
pump assembly
2、 Check the diluent temperature
detection unit and main control board
in turn.
Waste
115-025641-00
Vacuum
chamber assembly
Vacuu
m
pressu 0x060
re
00101
abnor
mal
Pressure
out of the
range
specified by
the
sequence
801-3201-00003-00 New
3-way
micro-electromagnetic
valve
801-3201-00002-00 2-way
micro-electromagnetic
valve (short line, new
connector)
1、 Go to the Temp & Pressure screen,
and check whether the error exists;
2、 Check the waste pump and the
connecting cables of the valves and
pump in turn.
3、 Check the vacuum chamber, valves
and related tubing in turn for leakage.
009-004358-00 Cables of
the valves and pump
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Single lane model (BC-10/11/10e/20/21)
aperture voltage normal range: 7.5V-18V
(same as those of the WBC and RBC
counting baths)
Dual
lane
(BC-30/31/30e/20s/21s/30s/31s):
Cloggi
0x070
ng(WB
00101
C)
WBC
aperture
voltage high
115-025645-00
bath module
⚫
Normal voltage range of WBC counting
aperture: 6.5V-14.5V
⚫
Normal voltage range of RBC counting
aperture: 8.5V-18.8V
WBC
Probe Cleanser
model
1、 Check the residual volume of the
diluent and its model;
2、 Check the counting baths for leakage
of liquid or gas;
3、 Probe cleanser maintenance
4、 Uninstall and clean the aperture.
Cloggi
ng(RB
C)
0x070
00102
RBC
aperture
voltage
high
1、 Check the residual volume of the
diluent and its model;
115-025644-00
bath module
Probe Cleanser
RBC
2、 Check the counting baths for leakage
of liquid or gas;
3、 Probe cleanser maintenance
4、 Uninstall and clean the aperture.
1、 Check
Signal
interfer
0x07000
ence of
601
WBC
lane
Strong
interference
signal
/
detected in
the
WBC
lane
Signal
interfer
0x07000
ence of
602
RBC
lane
Strong
interference
signal
/
detected in
the
RBC
lane
the instrument, such as
whether the grounding screw is
normal, and whether the shielding box
is open;
2、 Look for the external interference sources,
such as whether the external power supply
is stable and whether there are strong
interference objects near the instrument.
1、 Check
No.: HXQ-19001-New 3-DIFF
the instrument, such as
whether the grounding screw is
normal, and whether the shielding box
is open;
2、 Look for the external interference sources,
such as whether the external power supply
is stable and whether there are strong
interference objects near the instrument.
Version: 1.0
IVD Global Technical Support Dept.
1、 Check the WBC bath to see whether
there is unexpected substance;
HGB
blank
voltag
e
abnor
mal
0x070
00201
115-025640-00
HGB 2、 Check the WBC bath for leakage;
HGB blank
3、 Check whether the exterior of the WBC
voltage out assembly
bath is clean;
of
range 115-025645-00 WBC bath
[3.85,
module
4、 Probe cleanser maintenance
4.85]V
Probe Cleanser
5、 Set HGB gains
6、 Replace the HGB assembly, and set
the HGB gain.
Apertu
re
voltag
0x070
e
00301
abnor
mal(W
BC)
Apertu
re
voltag
0x070
e
00302
abnor
mal(R
BC)
Backgr
0x070
ound
abnor 00401
mal
Aperture
voltage in
WBC
counting
process is
lower than
7.2 V.
Aperture
voltage in
RBC
counting
process low
115-025645-00 WBC bath 1、 If the diluent temperature sensor error
module
is reported at the same time, deal with
it first;
2、 Check the model of the diluent;
3、 Check whether there is leakage or
overflow;
115-025644-00 RBC
bath module
Startup
background
results
unqualified
4、 Uninstall the aperture, and make sure
the sealing ring is clean.
1、 Make sure the models of the reagents
are correct;
Probe Cleanser
2、 Make sure the signal line is grounded
safely, and the installation of the
shielding box is reliable;
3、 Probe cleanser maintenance
IP
addres 0x080
s
00101
conflict
Find
that
the
IP
address of
the
instrument /
conflicts
with that of
a host in
the network
No.: HXQ-19001-New 3-DIFF
Contact the network administrator to
re-assign a new IP address and modify
the setting
Version: 1.0
IVD Global Technical Support Dept.
No
paper
or
paper
jam
0x090
00101
No paper or
No paper or paper jam
paper jam
Other
printer
error
0x090
00102
Other
Please contact the service department of
paper or paper jam in the
printer error
the printer supplier.
Check whether there is no paper or paper
jam
Other errors besides no
printer
Printer
0x090
not
conne 00103
cted
Printer not
Printer not connected
connected
Recor
der
error
0x090
00201
Recorder
Recorder
communica
error
tion error
0x090
00202
No paper
in
the
1、 Check whether there is no paper in the
recorder
recorder;
No paper in the recorder or
or
recorder cover open
2、 Check whether the front cover of the
recorder
recorder is properly closed.
cover
open
0x090
00203
Recorder
Recorder
print head
overheated
overheated
No
paper
in
record
er
Recor
der
error
1、 Check that the printer data cable is
properly connected to the instrument;
2、 Check that the printer works properly;
communication Check whether the connecting cable of the
recorder is properly connected.
print
1、 Network
cable
connected.
1、 Check whether the recorder print head
is overheated;
head
2、 Stop printing before the print head
cools down.
not
1、 Check whether the network cable is
properly connected;
2、 The network between
2、 Check whether the network between
the instrument and the
the instrument and the LIS system
LIS system does not
works well;
work;
Comm
unicati
0x0A0
on
00101
discon
nected
Communic
ation
disconnect
ed
Comm
0x0A0
unicati
00102
on
Protocol
Make sure the LIS system is designed in
Protocol analyzing error in
analyzing
consistence with the protocol provided by
error in the the communication process
the manufacturer of the instrument
communica
3、 The IP address or port
ID set for the LIS
system are incorrect.
No.: HXQ-19001-New 3-DIFF
3、 Check the IP address and port ID for
LIS
connection
are
properly
configured.
Version: 1.0
IVD Global Technical Support Dept.
error
tion
process
LIS
acknowledg 1、 Network
cable
not 1、 Check whether the network cable is
ment
connected.
properly connected;
overtime in
2、 Check whether the network between
2、 Communication
the
the instrument and the LIS system
disconnected between
communica
works well;
LIS and the instrument
tion
process
Comm
unicati 0x0A0
on
00103
error
115-025651-00 Screen
assembly (8.4 inches)
115-039856-00Screen
assembly (8.4 inches)
009-007651-00 Small
LCD cable
Screen
flickeri
ng or /
blacko
ut
/
115-025652-00 Screen
assembly (10.4 inches)
See 错误!未找到引用源。错误!未找到引用
源。.
009-007650-00 LCD
cable
051-001714-00 3008
main control board
Multimeter
021-000271-00 Touch
screen, electric resistance,
8.4 inches, 4-lead
Screen
used
/
improp
erly
009-004655-00 Cables of
small touch screen
/
801-3110-00184-00
Touch
screen,
resistance,
10.4
4-lead
Cables
screen
See 错误!未找到引用源。错误!未找到引用
electric
inches,
源。.
009-004366-00
of small touch
051-000881-00 6301 touch
screen control board PCBA
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
18.2 Troubleshooting Flowchart
18.2.1 HGB Blank Voltage Abnormal
0x07000201-HGB blank voltage abnormal
Error report mechanism: HGB blank voltage out of range [3.85, 4.85]V
Enter Menu - Setup - Gain Setup and
execute Automatically Set HGB B.V
In the Gain Setup screen,
confirm whether the "HGB B.V" blank
voltage is within the range of [3.85,
4.85] V. You are recommended to
adjust it to about 4.2V.
Y
Enter the counting screen to
perform a blank test, and confirm
whether it is normal.
N
N
Y
Check whether HGB assembly
indicator is On
N
Y
Re-plug the cables of
HGB assembly or
replace the HGB
assembly/main control
board
Check the level of the WBC
counting bath during the test,
low level check, solenoid
valve, syringe, counting bath,
and isolation chamber
No.: HXQ-19001-New 3-DIFF
Check if the WBC counting
bath is dirty or has bubbles.
Clean it or perform reagent
priming
Check the WBC counting
bath for leakage of liquid or
gas. Please confirm the
pump that mixes bubble or
replace the counting bath.
Version: 1.0
Complete
IVD Global Technical Support Dept.
18.2.2 Background Abnormal
Error report mechanism: the startup does not meet the background
requirements [WBC<0.2, RBC<0.02, HGB<1, HCT<0.5, PLT<5]
0x07000401--Background abnormal
Enter Menu-Service-Maintenance-Repair,
use the probe cleanser to maintain the WBC
and RBC counting baths. After maintenance,
you are recommended to clean the counting
baths multiple times.
Perform a blank test to see if the test
results meet the startup background
requirements.
Y
N
N
Confirm the
ambient
temperature,
check the
opening time of
the diluent, and
whether there is
crystallization in
the diluent
container, and
replace new
diluent for testing.
Check the
diluent cap
assembly for
contamination,
clean it, and
carry out the
test after
soaking the
whole
instrument.
Check the diluent
tubes for
crystallization.
Carefully clean or
soak the diluent
tubes with the
probe cleanser.
Check if the
diluent tubes are
aging or have
burrs. You are
recommended to
replace the tubes.
Check the
preheating bath
for leakage or
impurities, and
then clean or
replace it.
Check the
counting bath for
leakage or
crystallization,
and test the
instrument after
excluding the
above causes. If
the fault still
remains, replace
the counting bath.
If the HGB background is
abnormal, check whether
the lyse has deteriorated,
check whether the tubes for
addition of lyse are aging or
have burrs, and check the
connectors for leakage of
gas.
If the PLT background
result is very high or covered
by asterisk, consider the
external interference signal--zero ground voltage should
be less than 5V, there cannot
be any oscillator or large
equipment near the
instrument; or the internal
shielding effect is not good replace the shielding box
assembly, counting bath
assembly (With aperture),
and main control board.
Complete
18.2.3 Motor Error of Lift Mechanism of Sample Assembly
Aspiration module lift mechanism error or aspiration module rotary
mechanism error
Error report mechanism: The positioning optical
coupler signal of the sampling mechanism is abnormal
Are repeated
self-tests
normal?
0x02nn0201--Not inside
the sensor area after the
action is completed;
0x02nn0202--Inside the
sensor area after the action
is completed;
0x02nn0203 and
0x02nn0303—Other faults;
Y
0x02nn0301--Current
position unknown;
0x02nn0302--Not inside
the sensor area after the
action is completed
N
1. First upgrade to the latest
version of the software, and then
perform the test.
No.: HXQ-19001-New 3-DIFF
2. Check the optical coupler and motor
connection to confirm that the
connection is good, and use the
grease to lubricate the mechanical
mechanism.
3. Enter Menu - Service - Sample Probe
Debug. Based on the alarm, test the
statuses of the motor and optical coupler,
and confirm the fault point. Replace the
optical coupler, main board or sample
assembly,
Version: 1.0
The components of the
instrument are normal, but the
movement resistance is large.
You are recommended to
apply lubricant. If not, replace
the entire motor assembly.
IVD Global Technical Support Dept.
18.2.4 Power Error
Error report mechanism:
Voltage out of range
Power Error
Enter Menu - Status - Voltage & Current, and
view all voltages
Check if the constant
current source voltage is
within the range of
[47, 63] V
Y
Check if the analog +12V
voltage is within the range
of [11,14] V
Y
Check if the analog -12V
voltage is within the range
of [-14, -9] V
Y
Check if the power 12V
voltage is within the range
of [11,14] V
Check if the analog 24V
voltage is within the range
of [20,30] V
Y
Y
N
1. Detect the mains voltage and
reconnect the connectors
between the power board and the
main board to ensure good
contact.
2. Confirm whether the two
connectors between the power
board and the main board
connecting cable are well
connected.
3. Use the universal meter to check
the output voltage of the power
supply board ± 12V, 24V, 30V, and
5V. If abnormal, you are
recommended to replace the power
board.
4. If the power board output is
normal but the fault remains, you
are recommended to replace the
main control board.
Complete
18.2.5 Clogging
0x07000201—Clogging
Error report mechanism: Aperture voltage high or interference
BC-20s, 21s, 30s, 31s, 30, 31, and 30e models are dual-lane
instruments; BC-10\10e\11\20\21 are single-lane instruments;
Enter Menu-Services-Self-Test and check
"WBC or RBC Aperture Voltage”
Is the instrument model
BC-10\10e\11\20\21?
N
Y
Check if the aperture
voltage of the dual-lane model
is within the range of:
[5.5, 14.5] V for WBC
[8.5, 18.8] V for RBC
Check if the aperture voltage
of the single-lane model is
within the range of
[7.5, 18] V
Y
N
N
Confirm grounding. The zero
ground voltage is less than 5V,
and there is no high-power
equipment nearby.
Burn, backflush, and clean the
aperture. If the fault still remains,
use the probe cleanser to soak
and clean the counting bath.
No.: HXQ-19001-New 3-DIFF
Check if the counting bath is
injected with diluent. If not, check
the reagent volume, solenoid
valve, and syringe.
Check the counting baths for
leakage of liquid or gas; if so,
replace the counting bath.
Replace the main board
Version: 1.0
Complete
IVD Global Technical Support Dept.
18.2.6 Vac Pressure Error
0x06000101-- Vacuum pressure error
Error report mechanism: Vacuum pressure out of range
Enter the Menu-StatusTemperature&Pressure screen to verify the
vacuum pressure value
Verify that the waste pump is
operating normally
Y
Unblock the waste tube and
ensure that the waste tube
is not pressed or folded
Is the pressure status
normal?
Y
N
N
Check if the cable of waste
pump is well connected, replace
the waste pump, and replace the
main control board
Check air
tightness of
tubes and
connectors
Check cables of
SV04\SV08\SV09
solenoid valve and
solenoid valve
No.: HXQ-19001-New 3-DIFF
Check the connector of vacuum
chamber for cracks, such as
aging and discoloration. You are
recommended to replace the
vacuum chamber assembly.
If there is no problem in tubes, consider
whether the pump is aging and whether
the flow is insufficient; if so, replace the
waste pump; if there is a problem with the
sensor, replace the main control board
Version: 1.0
Complete
IVD Global Technical Support Dept.
19Service-Related Engineering Change Traceability Table
ID
Release
Date
CTXQ-18043 2018-10-31
No.: HXQ-19001-New 3-DIFF
Is
Is
Software Hardware
Involved Involved
Y
Y
Software
Version
Software Change Point
1. The new version of the
software modifies the
timing and solves the
problem of
“Deflection/Lift motor
failure” when the
instrument is tested in
large sample size;
2. The new version of the
software adds the
functions of preheating
V01.12.00.2403
tank emptying and the
whole instrument
emptying;
3. The new version of the
software adds a Save
button for setting
changes for the System
Configuration screen.
After completing the
settings and modifying,
click the Save button to
Version: 1.0
Hardware Change Point
1. Change the grounding of
the diluent inlet to the
metal connector to avoid
interference. When
replacing the old
connector with the new
connector, please cut off
the plastic connector of
the diluent cap assembly
and connect the tube
directly to the metal
connector. Material code
of metal connector in the
new version:
115-058813-00
2. Change the screen wire
and solve the problem of
splash screen by changing
the screen wire. The new
version is fully
compatible with the old
version; material code:
Warnings and
Precautions
IVD Global Technical Support Dept.
save the modified
parameters.
CTXQ-18022 2018-7-31
No.: HXQ-19001-New 3-DIFF
Y
N
1. The new version of the
software optimizes the
heating of the syringe
and the sample assembly
motor, which causes the
temperature inside the
instrument to rise. The
problem of increasing
the deviation of the HGB
test parameters is
V01.11.00.2302 solved.
2. The new version of the
software modifies the
bug that the motor
cannot respond to the
running information
under certain
conditions, and solves
the abnormal fault
occasionally reported
by the motor;
Version: 1.0
009-004364-00 LCD cable
(10.4-inch screen)
009-004471-00 Small LCD
cable (8.4-inch screen)
IVD Global Technical Support Dept.
3. The new version of the
software increases the
upper limit of the time
setting range for
entering the standby
status, changing it from
30min to 90min;
4. Solve the problem of
reporting abnormal
temperature of the
preheating bath when the
instrument is turned on
or standby at very low
temperature.
CTXQ-18015 2018-4-24
No.: HXQ-19001-New 3-DIFF
N
Y
Not involved
Version: 1.0
Change of air pump
assembly:
1.
BC-30s/30/31s/31/20s/21s
dual-lane models use the
old version of the pump
assembly 115-025715-00;
2. The BC-20/21/10/11
single-lane models use
the new version of the air
pump module
TCN18-GR002-002;
3. The new version of the
material is compatible
IVD Global Technical Support Dept.
with the old version, but
the old version is not
compatible with the new
version;
CTXQ-17007 2017-4-21
CTXQ-16022 2016-6-21
No.: HXQ-19001-New 3-DIFF
Y
N
N
V01.05.00.1921
Enhanced closed reagent
function
1. New material: Touch
screen material (Material
code: 021-000271-00). The
physical size of the
changed touch screen is
larger than those before
the change, but the
thickness is relatively
small, and the touch
screens before and after
the change are
incompatible.
2. The new front cover
assembly of BC-20S/21S
instrument is matched
with the new touch screen
(Material code:
021-000271-00):
043-007675-00 front cover
assembly (BC-20S); 043007674-00 Front cover
Y
Version: 1.0
Service tips:
1) Before the
BC-20S/21S
instrument is
changed, the
touch screen
is faulty. If
there is any
spare parts
inventory of
the touch
screen before
the change,
repair and
replace it.
Otherwise,
repair and
replace it
with the new
front cover
assembly.
IVD Global Technical Support Dept.
assembly (8-inch tender)
3. The BC-20S/21S
instrument adds the front
cover assembly, which
includes: screen
component, touch screen,
indicator board, and the
entire front cover. The
front cover assemblies
before and after the
change are compatible;
115-039857-00 front cover
assembly (BC-21S);
115-039858-00 front cover
assembly (8.4 inches)
4. The BC-20S/21S
instrument adds 8.4"
screen component. The
8.4" TFT screen in the
8.4" screen component
before and after the
change is the same
material (Material code:
021-000166-00), and the
materials such as the
screen fixing board are
not compatible, resulting
in screen component
No.: HXQ-19001-New 3-DIFF
Version: 1.0
2) Before the
BC-20S/21S
instrument is
changed, the
front cover is
faulty. If
there is the
front cover
inventory
before the
change, repair
and replace
it. Otherwise,
repair and
replace it
with the new
front cover
assembly.
3) The screen
component, the
touch screen
and the front
cover assembly
before the
change must be
used together;
the changed
screen
IVD Global Technical Support Dept.
materials are not
compatible;
115-039856-00 screen
component (8.4 inches)
CTXQ-15020 2015-8-11
No.: HXQ-19001-New 3-DIFF
Y
N
1. Add multi-language
(Portuguese, Spanish,
French, Russian, and
Indonesian) screen
display;
2. Edit information and
V01.03.00.1880
WBC histograms on the
sample analysis screen;
3. Modify the reference
value of the HGB
background voltage to
4.2V.
Version: 1.0
component,
touch screen
and front
cover assembly
should also be
used together.
20Alignment
20.1 Align the Mechanical Position
N
ot
e
Figure 20-1
Contro
Contents
l Point
Standard
Click Service →Sample Probe Debug Enter the
1.1
Alignment screen, as shown in Figure Figure
20-1.
Figure 20-2
RBC bath (The single-lane
1.2
A
Coarse-tun
sample probe above the WBC bath and loosen
e
the four screws as shown in Figure 10-3.
relative
the
the
li
probe
configuration)
gn
counting
th
bath
sc
re
ws
in
th
e
fr
on
t
an
d
re
ar
of
sample
model does not have this
e
20-1
First click the "Initialize" button, place the
position
Control
and
IVD Global Technical Support Dept.
Figure 20-3
1.3
Click the “Middle Position” button to expose the
Fine-tune
The sample
probe wipe of the sample probe, fine-tune the left
the
probe
and right sides of the counting bath, and make
position
the sample probe near the center of the bath
the
cover, but it cannot be in contact with the
probe
counting bath module. Then tighten the four
counting
the counting
screws and the screw torque is 3.2-4.5 kgn.
bath
bath
and
of
sample
and
assembly
cannot be in
contact with
module.
Align the screws in the
left
relative
Tighten the
right
screws;
positions.
Click the “Home Pos” button, then click the
“Down Position” button to check if the sample
probe is not in contact with the counting bath. If
contact, adjust the relative position according to
1.4
steps 1.2 to 1.4. Repeat this step to check
whether the relative position of the sample probe
and the counting bath is adjusted successfully.
During the process, the sample probe cannot
contact the cover of the counting bath.
Warnings and Precautions:
1. In Figure 20-1, when the “Initialize” button is not clicked, all the buttons except the
“Initialize” button in the figure are grayed out. Only after the initialization is completed,
the three buttons in the “Sample Probe Deflection Position” column will be highlighted
and available. The "Middle Pos" and "Down Pos" buttons are only available when the
"WBC Bath" or "RBC Bath" buttons are clicked.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
To
oli
ng
N
ot
e
Figure 20-4
Control
Control
Point
Standard
Contents
The
For a dual-lane instrument, click “Home Pos”
Align
sample
-> “RBC Bath” to align the sample probe to
relative position
screws;
the RBC bath position. Refer to steps 1.2 to
of
2.
1.4 to align the relative position of the RBC
bath and the
probe
bath and the sample probe. This step is not
sample probe.
cannot be in contact
probe must
touch
bottom
Figure20-5
3008-J02 Probe Wipe Position Setter
the
of
1.
5
the fixture.
the
the
RBC
performed on a single lane instrument.
1.
Tighten
The
the
sample
assembly
with the counting
bath module.
1.
6
Click the “Position Setter” button to align the
Align
sample probe to the top of the WBC bath. Use
relative position
probe
the Probe Wipe Position Setter to align the
of
contact
relative position of the probe wipe and the
wipe and the
Probe
sample probe according to the positions as
sample probe
Position Setter
Click “Home Pos” and then click the “WBC
Confirm
The
sample
Bath”, “Horizontal Sample Pos” and “RBC
sample
probe
cannot
Bath” buttons to see if the sample probe is
positions
the
the
probe
The
sample
must
the
Wipe
shown in Figure 20-4 to Figure20-5. The
screw torque is 3.2 to 4.5 kgn.
1.
7
Lock the pan head screw on
scratching other parts.
the probe fixture.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
probe
scratch
parts.
other
IVD Global Technical Support Dept.
Warnings and Precautions:
1、 Perform step 1.5 only for dual-lane models. The single-lane model does not have the
RBC bath. This step is not required.
2、 Since the deflection of the motor will bring about the height change in the vertical
direction of the sample probe, when the probe wipe is set to a certain height, the Position
Setter button must be clicked so that the sample probe is above the WBC bath position.
Do not set the height at other positions. Do not click the WBC Bath Pos button directly.
20.2 Align the Detection Components
20.2.1 Detect the Counting Lane
Figure 20-6
Note
4.1
4.2
No.: HXQ-19001-New 3-DIFF
Contents
Control
Control Standard
Point
Open the shielding box of the counting bath and
perform multiple blank counts in "WB" mode.
Observe that there is no liquid column in the
Sampling
There is no liquid column in
sampling tubes and no liquid in the sample probe
tubes,
the sampling tubes and no
during a complete counting process. Otherwise,
sample
liquid in the sample probe;
replace the sampling tubes to confirm that there
probe,
there is no gas column in
is no gas column in the sample preparation
counting
the
tubes, and that there is no bubble when the
bath
tubes, and there is no
sample
preparation
relevant tubes of the WBC bath and RBC bath
bubble when the relevant
are full.
tubes are full.
Version: 1.0
IVD Global Technical Support Dept.
4.3
Observe whether the liquid level is normal after
WBC
and
Liquid does not splash from
the WBC and RBC counting baths are added in
RBC
the WBC and RBC counting
the whole counting process; whether the sample
counting
baths,
probe is lower than the liquid level after entering
baths
good, bubbles do not touch
bubble
aspiration
mixing
tube,
is
the counting bath every time, whether there is
the
the
splash and whether bubble mixing exist when
sample probe tip is lower
adding liquid; whether the bubbles are in contact
than the level every time,
with the aspirate tube; whether the emptying of
the emptying of the WBC
the WBC and RBC counting baths is normal.
and RBC counting baths is
normal, and there is no
liquid on the walls of the
counting baths.
No RBC Aperture voltage in
Click “Service→Self-Test” in the menu bar of the
Aperture
The aperture voltage is
the
main screen to enter the self-test screen. As
voltage
normal, and there is no
single-lane
instrument
screen
4.4
shown in Figure 20-6, click the “RBC Aperture
alarm.
Voltage” and “WBC Aperture Voltage” buttons,
respectively.
4.5
Install the shielding cover of the counting bath
Tighten the
with the M3X8 stainless
screw;
combination
screw
and
cross-headed screwdriver.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
steel pan head
tighten
it
with
a
IVD Global Technical Support Dept.
4.6
Perform another count to observe the action of
Relative
Relative position of the
the sample probe assembly during the entire
position
counting process. When the liquid is mixed well
the sample
shielding
in the counting bath, the sample probe does not
probe
counting bath
interfere with the shielding box.
the
of
and
sample
probe
box
and
the
of
the
shielding
box of the
counting
bath
Note: The gas column mentioned in the text refers to a large bubble that separate the liquid path in the
tubes.
20.3 Save Settings
After modifying the settings in each setup screen, if you want to save the settings, you can switch the screen. The following saving prompt will pop
up.
Click "Yes" to save the settings, close the prompt box and switch to the target screen. Click "No" not to save the settings, close the prompt box and
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
switch to the target screen.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
20.4 Verify Service Alignment
Part Name
Alignment
Material ID
Confirmation Item
Requirements
1. Follow the prompts to
back up the configuration
3008 main control
data.
051-001714-00
board PCBA
Version Info correct
2. View the corresponding
version information on the
Version Info screen.
Dual syringe drive
115-020624-00
assembly
10
ml
syringe
801-3003-000
27-00
(FRU)
Syringe
sensor
3101-20-68304
barrier
Recalibrate
Verification of Repeatability
Tailor-made screw
041-005167-00
3
Mindray
250ul
syringe
(with
115-027479-00
Sampling assembly
115-025638-00
connector)
1.
When
the
sample
assembly moves up and
Motor
down or left and right, the
position
801-3003-00015
sensor
assembly
-00
(FRU)
801-3001-00055
Sensor assembly1
-00
sampling tubes are smooth,
neither
folded,
interfered
with
nor
the front
plate, liquid path partitions,
Verification of Repeatability
right doors, motors, valves,
wire buckles, etc.
Probe
wipe 801-1805-000
assembly (FRU)
Sample probe
04-00
2. Ensure that the sampling
tubes are not squeezed or
801-1805-000
deformed
03-00
through the wire buckles.
No.: HXQ-19001-New 3-DIFF
when
passing
Version: 1.0
IVD Global Technical Support Dept.
3. Ensure that the incoming
and outgoing tubes of the
probe wipe assembly are
not
folded
or
interfered
when the sample assembly
moves left and right or up
and down.
4. Mechanically align the
relative
position
of
the
probe and WBC\RBC bath
5. Recalibrate
1. Mechanically align the
relative
position
of
the
probe and bath;
2. The waste pipe of the
counting bath should be
RBC
bath
wound one round in the
115-025644-00
assembly
Verification of Repeatability
vertical direction, and the
winding
height
is
3cm
higher than the liquid level
of the counting bath.
3. Perform gain calibration
4. Recalibrate
1. Mechanically align the
relative
position
of
the
probe and bath
2. The waste pipe of the
counting bath should be
1. Confirm repeatability
WBC
bath
wound one round in the
115-025645-00
assembly
2. The HGB blank voltage is
vertical direction, and the
4.1 V
winding
height
is
3cm
higher than the liquid level
of the counting bath.
3. Perform gain calibration
4. Recalibrate
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
1. Mechanically align the
relative
position
of
the
probe and bath;
2. The waste pipe of the
counting bath should be
Single-lane
1. Confirm repeatability
wound one round in the
counting
bath
115-049501-00
2. The HGB blank voltage is
vertical direction, and the
module
4.1 V
winding
height
is
3cm
higher than the liquid level
of the counting bath.
3. Perform gain calibration
4. Recalibrate
Confirm that the sampling
Shielding
bottom
Mechanically align the RC
assembly will not touch the
bath position
RBC bath when moving up
042-011786-00
plate welding piece
and down in the RBC bath.
HGB assembly
Vacuum
115-025640-0
Perform
0
calibration:
chamber
the
HGB
gain
The HGB blank voltage is
4.1 V
Confirm that the reaction
115-025641-00
unit
bath
can
be
emptied
/
Waste
normally and the vacuum
pump
115-025643-00
assembly
can be achieved normally.
2-way
1.
micro-electromagn
Confirm
inlet/outlet
that
direction
the
is
801-3201-00002
etic
valve
(short
correct;
-00
line,
new
2. Insert the tube to the end.
/
connector)
New
3. Connect and unplug the
tubes
3-way
micro-electromagn
801-3201-000
the
valves,
connectors, etc. Do not
03-00
etic valve
with
insert them again.
1. Confirm that the normally
SMC
3-way
fluidic
valve
assembly (3106)
open end, normally closed
115-015967-0
0
/
end, and public end are
connected correctly;
2. Insert the tube to the end.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
3. Connect and unplug the
tubes
with
the
valves,
connectors, etc. Do not
insert them again.
Front
cover
043-005464-00
assembly (BC-30S)
Long weather strip
for
10
in
touch
047-016362-00
screen
Short weather strip
for
10
in
touch
047-016363-00
screen
Front
cover
043-007675-00
assembly (BC-20S)
Long weather strip
for
8
in
touch
047-005535-00
Confirm
screen
that
the
touch
PerformTouch Screen Cal.
screen works properly.
Short weather strip
for
8
in
touch
047-005536-00
screen
Touch
screen,
10.4”, 4-lead (FRU)
Touch
801-3110-00184
-00
screen,
electric resistance,
021-000271-00
8.4＂, 4-lead
Screen
assembly
115-025652-00
(10.4 in)
Screen
assembly
115-039856-00
(8.4 in)
1. J9 and three-way head
Confirm
that
the
C10 must be inserted into
Diluent
heating
temperature is within the
115-049623-00
the end
assembly (20W)
range
2. The fru record parameter
screen.
is used for entry of a new
No.: HXQ-19001-New 3-DIFF
Version: 1.0
under
the
status
IVD Global Technical Support Dept.
temperature value in the
temperature
calibration
screen
Set time and date on the
Button cell Lithium
The date after startup is the
801-3100-00226
time and date screen, and
-00
power off after saving the
3V35mAh
same
D12.5*2.0
shutdown.
settings
1. Back up the data before
replacing the SD card (if
SD
card
as
8GB
023-001056-00
available);
/
Class10
2. Perform an operation of
restoring configuration data;
No.: HXQ-19001-New 3-DIFF
Version: 1.0
before
the
IVD Global Technical Support Dept.
21Maintenance BOM
Maintenance Code
115-025638-00
Name
Sampling assembly
Touch screen, electric resistance, 8.4 ＂ ,
021-000271-00
4-lead
Touch screen, electric resistance, 8.4 ＂ ,
021-000073-00
4-lead
Handheld 1D Code Scanner Red Light USB
023-000866-00
023-001524-00
Interface (Firmware v2.04.57)
SD card 8GB MLC
Class10
FAN 12Vdc 40*40*10MM 4.1cfm 25dB
024-001032-00
300mm
041-020880-00
Probe Wipe Position Setter
042-005948-00
Upper signal shielding cover
042-005949-00
Lower signal shielding cover
042-011528-00
Shielding box
042-011531-00
Key installation board
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
Isolation chamber filter (injection molding)
043-000829-00
Reagent detection tube
043-007675-00
Front cover assembly (BC-20S)
043-005463-00
Front cover assembly (BC-20S)
043-005464-00
Front cover assembly (BC-30S)
043-005810-00
Start button (BC-20S)
043-008994-00
Start button (BC-20S)
043-005587-00
Front cover assembly (10 inches for a tender)
043-007674-00
Front cover assembly (8 inches for a tender)
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 weather strip for 8 in touch screen
047-005536-00
Short weather strip for 8 in touch screen
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
047-016362-00
Long weather strip for 10 in touch screen
047-016363-00
Short weather strip for 10 in touch screen
051-001621-00
Liquid detection board PCBA
051-001714-00
3008 main control board PCBA
051-001857-00
3008 keypad PCBA
051-001319-00
3107 power board PCBA
051-002708-00
3206 Burning power board PCBA
051-002911-00
3008 Switch power board PCBA
115-013091-00
Waste container cap assembly
115-015677-00
Diluent temperature detection unit
115-015967-00
SMC 3-way fluidic valve assembly (3106)
115-025639-00
Syringe assembly
115-025640-00
HGB assembly
115-025641-00
Vacuum chamber assembly
115-025642-00
Reagent detection assembly
115-025643-00
Waste pump assembly
115-025644-00
RBC bath assembly
115-025645-00
WBC bath assembly
115-049501-00
Single-lane counting bath module
Single-lane counting bath module (Without
115-050158-00
aperture)
115-025646-00
Power unit
115-054722-00
Power Supply Unit
115-045810-00
Power Supply Unit
115-025647-00
Start 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
Diluent heating assembly
115-049623-00
Diluent heating assembly (20W)
115-025651-00
Screen assembly (8.4 in)
115-025652-00
Screen assembly (10.4 in)
115-025654-00
Front cover assembly (10.4 in)
115-027955-00
Front cover assembly (BC-31S)
115-039857-00
Front cover assembly (BC-21S)
115-039858-00
Front cover assembly (8.4 in)
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)
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
115-039856-00
Screen assembly (8.4 in)
115-039901-00
Screen assembly upgrade material package
115-025715-00
Air pump assembly
115-027479-00
Mindray 250ul syringe (with connector)
115-028170-00
Instrument tube pack
115-028171-00
Hydropneumatics component package
115-030832-00
SD card material package (with software)
115-036143-00
3008 Active maintenance package
801-1805-00003-00
Manual sample probe (FRU)
801-1805-00004-00
Probe wipe assembly (FRU)
801-1805-00023-00
Isolation chamber (FRU)
801-2800-00016-00
TR60-H recorder (FRU)
801-2800-00018-00
Diluent container cap assembly (FRU)
801-3001-00055-00
Sensor assembly1
801-3003-00015-00
Motor position sensor assembly (FRU)
801-3003-00027-00
10ml Mindray syringe (FRU)
801-3007-00014-00
3007 Micro-switch (FRU)
801-3007-00029-00
3007 lyse container cap assembly (FRU)
801-3110-00167-00
Diluent container supporting board(FRU)
801-3110-00184-00
Touch screen, 10.4”, 4-lead (FRU)
021-000279-00
10.4″ 4-lead Touch screen
2-way micro-electromagnetic valve (short
801-3201-00002-00
line, new connector)
801-3201-00003-00
New 3-way micro-electromagnetic valve
M05-010R03---
Button cell Lithium 3V35mAh D12.5*2.0
M07-00131F---
FUSE Time-lag 250V 3.15AD5X20
Rubber tube. Silicone,1/16"X3/16",TYGON
M6G-020006--M6G-020056---
3350
Tube. EVA, ID: 1/16", OD: 1/8", clear
Tube. PTFE, 1/32” IDX1/16” OD, A.5
M90-000026---
(Design)
Connector. Female Luer, 1/4-28UNF, 1/8"ID,
M90-100009---
B.4 (Design)
Connector. Lock Nut, 1/4-28UNF, White
M90-100012---
Nylon
M90-100014---
Connector. LockNut, 1/4-28UNF, Red Nylon
M90-100026---
Connector. Male LuerPlug, White
M90-100027---
Connector. Straight Reduction,1/8"&3/32"ID
Connector.
M90-100028---
Nylon
Connector.
M90-100028-01
No.: HXQ-19001-New 3-DIFF
Tee,400Barb,3/32"ID,White
Straight,
400Barb,
White
Version: 1.0
3/32"ID,
IVD Global Technical Support Dept.
M90-100028-03
Connector. Y,400Barb,3/32"ID,White Nylon
M90-100031---
Tube. PTFE, 1.7mm IDX2.55 mm OD
M90-100048---
Connector. Coded LockRing, White
Connector. Coded Lock Ring, ForFTLLB or
M90-100050---
FTLB, Red
M90-100066---
Connector. Elbow Reduction
M90-100071---
Tube. 3/32"X5/32"
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Appendix A
Fluidics Diagram
Description of lyse addition process (The tubes with lyse flowing through are marked by red lines in the fluidics
diagram):
（1） BC-30s/31s/20s/21s: The lyse is aspirated by a 10ml syringe from the lyse vial through the tubes T48, T54,
T47 and valve SV07, into the T6 tube, and stored. The lyse, pushed by a 10ml syringe, passes through T6,
SV07, T7, and T8, and enters the WBC bath to participate in the reaction.
（2） BC-30/31: The lyse is aspirated by a 10ml syringe from the lyse vial through the tubes T48, T54 and valve
SV07 into the T6 tube, and stored. The lyse, pushed by a 10ml syringe, passes through T6, SV07, T7, and T8,
and enters the WBC bath to participate in the reaction.
（3） BC-20/21/10/11: The lyse is simultaneously aspirated by a 10 ml syringe and a 250 ul syringe from the lyse
vial through the tubes T15, T14 and valve SV07 into the T12 tube, and stored. The lyse, pushed by two
syringes simultaneously, passes through T12, SV07, T19, and T20, and enters the counting bath to
participate in the WBC reaction.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Reagent detection
Lyse vial
Diluent
container
Probe
wipe
Waste tank
Figure 21-1 BC-30s/31s/20s/21s Fluidics diagram
No.: HXQ-19001-New 3-DIFF
Version: 1.0
Isolation
chamber 2
Isolation
chamber 1
Preheating
bath
Temperature
Sensors
IVD Global Technical Support Dept.
Preheating
bath
Lyse vial
Diluent
container
Probe
wipe
Waste tank
Figure 21-2 BC-30/31 Fluidics diagram
No.: HXQ-19001-New 3-DIFF
Version: 1.0
Isolation
chamber 2
Isolation
chamber 1
Temperature
Sensors
IVD Global Technical Support Dept.
Preheating
bath
Isolation
chamber
Diluent
Lyse
Probe wipe
Waste tank
Figure 21-3 BC-20/21/10/11 fluidics diagram
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Appendix B
Comparison Table of Connectors
BC-30s/31s/20s/21s Fluidics diagram Material list
No.
Material Type
Names
Material ID
Unit
Quantity
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
4
Vacuum chamber
VC
115-015673-00
EA
1
5
Liquid pump
LP
3001-10-07252
EA
1
6
Air pump
GP
082-002497-00
EA
1
7
Sample probe
SPB
3001-10-07059
EA
1
8
Probe wipe
3001-30-06957
EA
1
115-002439-00
EA
1
3003-20-34949
EA
1
115-009948-00
EA
1
115-015677-00
EA
1
SV1
115-010088-00
EA
1
SV2
115-015967-00
EA
1
SV3
115-010089-00
EA
1
SV4
115-010089-00
EA
1
SV5
115-010088-00
EA
1
SV6
115-010088-00
EA
1
SV7
115-010088-00
EA
1
SV8
115-010088-00
EA
1
SV9
115-010088-00
EA
1
Probe
wipe
Isolation
9
Isolation chamber
chamber
1
Isolation
10
Isolation chamber
chamber
2
11
Preheating bath
Preheatin
g bath
Temperat
12
Sensor
ure
Sensors
13
14
15
16
17
18
19
20
21
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
valve
22
23
24
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
BC-30s/31s/20s/21s Fluidics diagram Material list
No.
Material Type
Names
Material ID
Unit
Quantity
25
Tube
T1
082-000108-00
mm
240
26
Tube
T2
082-000108-00
mm
210
27
Tube
T3
082-000108-00
mm
270
28
Tube
T4
082-000314-00
mm
20
29
Tube
T5
082-000314-00
mm
20
30
Tube
T6
3001-10-07069
mm
450
31
Tube
T7
3001-10-07069
mm
60
32
Tube
T8
3001-10-07069
mm
65
33
Tube
T9
082-000108-00
mm
50
34
Tube
T10
M6G-020055---
mm
1200
35
Tube
T11
082-000108-00
mm
50
36
Tube
T12
082-000108-00
mm
20
37
Tube
T13
082-000108-00
mm
20
38
Tube
T14
M6G-020055---
mm
270
39
Tube
T15
M6G-020054---
mm
1500
40
Tube
T16
082-000108-00
mm
440
41
Tube
T17
082-000108-00
mm
230
42
Tube
T19
3001-10-07069
mm
300
43
Tube
T20
3001-10-07069
mm
465
44
Tube
T21
3001-10-07069
mm
235
45
Tube
T22
M90-100071---
mm
390
46
Tube
T23
3001-10-07069
mm
310
47
Tube
T24
3001-10-07069
mm
180
48
Tube
T25
3001-10-07069
mm
330
49
Tube
T26
3001-10-07069
mm
320
50
Tube
T27
082-000314-00
mm
20
51
Tube
T28
082-000314-00
mm
60
52
Tube
T29
M90-100071---
mm
300
53
Tube
T30
082-000314-00
mm
120
54
Tube
T31
082-000314-00
mm
100
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
BC-30s/31s/20s/21s Fluidics diagram Material list
No.
Material
Type
Names
Material ID
Unit
Quantity
55
Tube
T32
M6G-020055---
mm
1500
56
Tube
T33
M90-100031---
mm
160
57
Tube
T34
M90-100031---
mm
160
58
Tube
T35
M6G-020006---
mm
20
59
Tube
T36
M6G-020006---
mm
20
60
Tube
T37
M90-100071---
mm
210
61
Tube
T38
M90-100071---
mm
220
62
Tube
T39
M90-100071---
mm
70
63
Tube
T40
M90-100071---
mm
30
64
Tube
T41
M90-100071---
mm
130
65
Tube
T42
M90-100071---
mm
140
66
Tube
T43
M90-100071---
mm
90
67
Tube
T44
082-000109-00
mm
220
68
Tube
T45
082-000109-00
mm
380
69
Tube
T46
M6G-020006---
mm
80
70
Tube
T47
3001-10-07069
mm
420
71
Tube
T48
3001-10-07069
mm
300
72
Tube
T49
A21-000002---
mm
180
73
Tube
T50
A21-000002---
mm
300
74
Tube
T51
082-000422-00
mm
400
75
Tube
T52
M90-100031---
mm
700
76
Tube
T53
3001-10-07069
mm
40
77
Tube
T54
3001-10-07069
mm
600
78
Tube
T55
M90-100071---
mm
45
79
Transfer tube
T56
3001-10-07069
mm
15
80
Transfer tube
T57
3001-10-07069
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
BC-30s/31s/20s/21s Fluidics diagram Material list
No.
Material
Type
Names
Material ID
Unit
Quantity
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
Sleeve
P1
082-000108-00
mm
200
C1
M90-100066---
EA
1
C2
M90-100027---
EA
1
C3
M90-100027---
EA
1
C4
M90-100066---
EA
1
C5
M90-100027---
EA
1
C6
M90-100026---
EA
1
C7
M90-100026---
EA
1
C8
M90-100027---
EA
1
C9
M90-100028---
EA
1
C10
M90-100028-01
EA
1
C11
M90-100028-01
EA
1
C12
M90-100028-03
EA
1
C13
M90-100024---
EA
1
C14
M90-100009---
EA
1
C15
M6Q-030111---
EA
1
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Tube
109
connector
Tube
110
connector
Tube
111
connector
Tube
112
connector
Tube
113
connector
Tube
114
connector
C16
M90-100009---
EA
1
C17
M6Q-030111---
EA
1
C18
M90-100009---
EA
1
C21
M90-100028-01
EA
1
C22
043-000892-00
EA
1
C23
043-000892-00
EA
1
BC-30s Fluidics Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
115
Tube connector
C24
M90-100100---
EA
1
116
Tube connector
C25
M90-100027---
EA
1
117
Tube connector
C26
M90-100027---
EA
1
118
BC-BC-30/31 Fluidic Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
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
VC
115-015673-00
EA
1
4
Vacuum
chamber
5
Liquid pump
LP
3001-10-07252
EA
1
6
Air pump
GP
082-002497-00
EA
1
7
Sample probe
SPB
3001-10-07059
EA
1
8
Probe wipe
3001-30-06957
EA
1
115-002439-00
EA
1
3003-20-34949
EA
1
115-009948-00
EA
1
9
10
11
Isolation
chamber
Isolation
chamber
Probe
wipe
Isolation
chamber
1
Isolation
chamber
2
Preheating
Preheatin
bath
g bath
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Temperat
12
Sensor
ure
115-015677-00
EA
1
SV1
115-010088-00
EA
1
SV2
115-015967-00
EA
1
SV3
115-010089-00
EA
1
SV4
115-010089-00
EA
1
SV5
115-010088-00
EA
1
SV6
115-010088-00
EA
1
SV7
115-010088-00
EA
1
SV8
115-010088-00
EA
1
SV9
115-010088-00
EA
1
Sensors
13
14
15
16
17
18
19
20
21
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
Electromagnet
ic valve
22
23
24
BC-30/31 Fluidic Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
25
Tube
T1
082-000108-00
mm
240
26
Tube
T2
082-000108-00
mm
210
27
Tube
T3
082-000108-00
mm
270
28
Tube
T4
082-000314-00
mm
20
29
Tube
T5
082-000314-00
mm
20
30
Tube
T6
3001-10-07069
mm
450
31
Tube
T7
3001-10-07069
mm
60
32
Tube
T8
3001-10-07069
mm
65
33
Tube
T9
082-000108-00
mm
50
34
Tube
T10
M6G-020055---
mm
1200
35
Tube
T12
082-000108-00
mm
20
36
Tube
T15
M6G-020054---
mm
1500
37
Tube
T16
082-000108-00
mm
440
38
Tube
T17
082-000108-00
mm
230
39
Tube
T19
3001-10-07069
mm
300
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
40
Tube
T20
3001-10-07069
mm
465
41
Tube
T21
3001-10-07069
mm
235
42
Tube
T22
M90-100071---
mm
390
43
Tube
T23
3001-10-07069
mm
310
44
Tube
T24
3001-10-07069
mm
180
45
Tube
T25
3001-10-07069
mm
330
46
Tube
T26
3001-10-07069
mm
320
47
Tube
T27
082-000314-00
mm
20
48
Tube
T28
082-000314-00
mm
60
49
Tube
T29
M90-100071---
mm
300
50
Tube
T30
082-000314-00
mm
120
51
Tube
T31
082-000314-00
mm
100
52
Tube
T32
M6G-020055---
mm
1500
53
Tube
T33
M90-100031---
mm
160
54
Tube
T34
M90-100031---
mm
160
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
BC-30/31 Fluidic Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
55
Tube
T35
M6G-020006---
mm
20
56
Tube
T36
M6G-020006---
mm
20
57
Tube
T37
M90-100071---
mm
210
58
Tube
T38
M90-100071---
mm
220
59
Tube
T39
M90-100071---
mm
70
60
Tube
T40
M90-100071---
mm
30
61
Tube
T41
M90-100071---
mm
130
62
Tube
T42
M90-100071---
mm
140
63
Tube
T43
M90-100071---
mm
90
64
Tube
T44
082-000109-00
mm
220
65
Tube
T45
082-000109-00
mm
380
66
Tube
T46
M6G-020006---
mm
80
67
Tube
T48
3001-10-07069
mm
300
68
Tube
T49
A21-000002---
mm
180
69
Tube
T50
A21-000002---
mm
300
70
Tube
T51
082-000422-00
mm
400
71
Tube
T52
M90-100031---
mm
700
72
Tube
T53
3001-10-07069
mm
40
73
Tube
T54
3001-10-07069
mm
600
74
Tube
T55
M90-100071---
mm
45
75
Transfer tube
T56
3001-10-07069
mm
15
76
Transfer tube
T57
3001-10-07069
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
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
BC-30/31 Fluidic Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
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
Sleeve
P1
082-000108-00
mm
200
C1
M90-100066---
EA
1
C2
M90-100027---
EA
1
C3
M90-100027---
EA
1
C6
M90-100026---
EA
1
C7
M90-100026---
EA
1
C8
M90-100027---
EA
1
C9
M90-100028---
EA
1
C10
M90-100028-01
EA
1
C11
M90-100028-01
EA
1
C12
M90-100028-03
EA
1
C13
M90-100024---
EA
1
C14
M90-100009---
EA
1
C15
M6Q-030111---
EA
1
C16
M90-100009---
EA
1
C17
M6Q-030111---
EA
1
C18
M90-100009---
EA
1
C21
M90-100028-01
EA
1
C22
043-000892-00
EA
1
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
connector
107
108
109
Tube
connector
Tube
connector
Tube
connector
No.: HXQ-19001-New 3-DIFF
C24
M90-100100---
EA
1
C25
M90-100027---
EA
1
C26
M90-100027---
EA
1
Version: 1.0
IVD Global Technical Support Dept.
BC-20/21/10/11 Fluidic Diagram Material List
No.
Material Type
Names
1
Tube
T1
2
Tube
3
Unit
Quantity
082-000108-00
mm
240
T2
082-000108-00
mm
270
Tube
T3
082-000108-00
mm
220
4
Tube
T4
M90-100031---
mm
460
5
Tube
T6
082-000422-00
mm
400
6
Tube
T7
3001-10-07069
mm
320
7
Tube
T8
3001-10-07069
mm
430
8
Tube
T9
082-000108-00
mm
95
9
Tube
T10
082-000108-00
mm
130
10
Tube
T11
3001-10-07069
mm
270
11
Tube
T12
3001-10-07069
mm
450
12
Tube
T14
3001-10-07069
mm
600
13
Tube
T15
3001-10-07069
mm
300
14
Tube
T16
082-000108-00
mm
50
15
Tube
T17
M6G-020055---
mm
420
16
Tube
T18
M6G-020054---
mm
1500
17
Tube
T19
3001-10-07069
mm
60
18
Tube
T20
3001-10-07069
mm
65
19
Tube
T21
3001-10-07069
mm
350
20
Tube
T22
3001-10-07069
mm
330
21
Tube
T23
3001-10-07069
mm
230
22
Tube
T24
082-000314-00
mm
20
23
Tube
T25
M90-100071---
mm
45
24
Tube
T26
M90-100071---
mm
300
25
Tube
T27
3001-10-07069
mm
40
26
Tube
T28
M90-100071---
mm
230
27
Tube
T29
082-000314-00
mm
60
28
Tube
T30
M6G-020006---
mm
80
29
Tube
T31
082-000109-00
mm
460
30
Tube
T32
082-000108-00
mm
320
No.: HXQ-19001-New 3-DIFF
Material ID
Version: 1.0
IVD Global Technical Support Dept.
BC-20/21/10/11 Fluidic Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
31
Tube
T33
M6G-020006---
mm
20
32
Tube
T34
M90-100031---
mm
160
33
Tube
T35
M6G-020006---
mm
20
34
Tube
T36
M90-100071---
mm
200
35
Tube
T37
082-000314-00
mm
40
36
Tube
T38
M90-100071---
mm
250
37
Tube
T39
M90-100071---
mm
260
38
Tube
T40
082-000314-00
mm
30
39
Tube
T41
082-000314-00
mm
120
40
Tube
T42
M6G-020055---
mm
1500
41
Tube
T43
A21-000002---
mm
180
42
Tube
T44
A21-000002---
mm
300
43
Tube
T45
3001-10-07069
mm
15
44
Tube
T46
082-000314-00
mm
20
45
Tube
T47
082-000314-00
mm
20
46
Tube
T48
082-000108-00
mm
20
47
Tube
J1
082-000055-00
mm
20
48
Tube
J2
0030-20-13339
EA
1
49
Tube
J3
082-000710-00
mm
20
50
Tube
J4
082-000710-00
mm
20
51
Tube
J5
M90-100071---
mm
25
52
Tube
J6
M6G-020006---
mm
25
53
Tube
J7
082-000710-00
mm
20
54
Tube
P1
082-000108-00
mm
200
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
BC-20/21/10/11 Fluidic Diagram Material List
No.
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
Material Type
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
connector
Tube
No.: HXQ-19001-New 3-DIFF
Names
Material ID
Unit
Quantity
C4
043-000892-00
EA
1
C5
M90-100027---
EA
1
C6
M6Q-030111---
EA
1
C7
M90-100009---
EA
1
C8
082-001140-00
EA
1
C9
082-001141-00
EA
1
C10
M6Q-030111---
EA
1
C11
M90-100009---
EA
1
C12
M90-100027---
EA
1
C13
M90-100100---
EA
1
C14
M90-100028-01
EA
1
C15
M90-100028-01
EA
1
C16
M90-100028-01
EA
1
C17
M90-100026--
EA
1
C18
M90-100026--
EA
1
C19
M90-100027---
EA
1
C20
M90-100027---
EA
1
C21
M90-100027---
EA
1
C22
M6G-030111---
EA
1
C23
M90-100009---
EA
1
Version: 1.0
IVD Global Technical Support Dept.
connector
75
76
Tube
connector
Tube
connector
No.: HXQ-19001-New 3-DIFF
C24
M90-100066---
EA
1
C25
M90-100027---
EA
1
Version: 1.0
IVD Global Technical Support Dept.
BC-20/21/10/11 Fluidic Diagram Material List
No.
Material Type
Names
Material ID
Unit
Quantity
77
Syringe
SR
115-015652-00
EA
1
78
WBC bath
WBC
115-025645-00
EA
1
VAC
115-015673-00
EA
1
79
Vacuum
chamber
80
Liquid pump
PUMP_WASTE
3001-10-07252
EA
1
81
Air pump
PUNP_PRSS
082-002497-00
EA
1
82
Sample probe
SPB
3001-10-07059
EA
1
83
Probe wipe
Probe wipe
3001-30-06957
EA
1
Isolation
Isolation
chamber
chamber
115-002439-00
EA
1
115-015677-00
EA
1
SV1
115-010088-00
EA
1
SV2
115-015967-00
EA
1
SV4
115-010089-00
EA
1
SV5
115-010088-00
EA
1
SV6
115-010088-00
EA
1
SV7
115-010088-00
EA
1
SV8
115-010088-00
EA
1
SV9
115-010088-00
EA
1
84
85
86
87
88
89
90
91
92
93
Sensor
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Electromagnetic
valve
Temperature
Sensors
94
95
96
97
98
99
100
No.: HXQ-19001-New 3-DIFF
Version: 1.0
IVD Global Technical Support Dept.
Appendix C
Sampling
assembly
Motor X2
Sensor X3
Syringe
assembly
Motor X1
Sensor X1
Hardware Block Diagram
Valve pump
X16
Preheating
X1
009-004358Electrical
grounding
Liquid
detection X2
Floater
009-004360-
009-004361-
00
00
009-004359-
00
00
009-004357-
Power Board
009-00435400
00
009-00435500
009-00435700
009-00435600
Loading
key
009-00436100
Power circuit
Motor
Power drive
Sensor
Liquid
detection
Floater&
Loading
Camera
Recorde Indicator
r
board
009-004362-
USB
USB
Recorde
r (Side
door)
00
009-00436300
009-00436400
009-004471-
LCD
LVDS
Electrical
grounding
009-004366-
LCD
touch
screen
00
009-00465500
Preheating
bath
US
B
Main Control
Board
Front
cover
Bac 00
klig
ht
Touch
screen
Digital
power circuit
Indicator
board
009-004367-
HGB
Tempe
rature
051-001714-00
Atmos
pheric
pressur
e
US
B
00
Diluent
009-00436800
LA
N
009-004369-
RBC
00
009-004370-
WBC
Analog
circuit
00
RBC
bath
Shielding
box
WBC
bath
Description: The RBC bath component is applicable to BC-30s/31s/20s/21s/30/31, and
BC-20/21/10/11 does not have this component.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
Vacuum
chamber
IVD Global Technical Support Dept.
Appendix D
Cables and Wires
Main
control
Material ID
Cable Name
Connection relationship
board
socket
009-004355-00
009-004356-00
Syringe motor cable
Connecting cable of
sample motor
J8
Syringe assembly Code, 115-025639-00
Sampling component, 115-025638-00
J7
UP: Motor above
DOWN: Motor below
Sampling assembly, 115-025638-00
UP: Upper optical coupler of sampling
009-004357-00
Connecting cable of
motor optical coupler
J12
assembly
LEFT: Left optical coupler of sampling
assembly
Right: Right optical coupler of sampling
assembly, INJ: Syringe optical coupler
V1-V10: Valves corresponding to the silk
009-004358-00
Connecting cable of
valve pump
J9
screens on the partition boards
GAS: Air pump, 115-025715-00
WAS: Waste Pump, 115-025643-00
009-004359-00
Connecting cable of
heater
J11
position
detection
board
J14
connection cable
Connecting cable of
009-004361-00
floater
with
the
J15
aspirate key
009-004362-00
009-004363-00
009-004367-00
009-004371-00
3101-20-68592
009-004369-00
Connecting cable of
recorder
Keypad cable
Temperature sensor
cable
Reagent: Connect the reagent tube
Diluent: Connect the diluent tube
White connector for aspirate key and
black connector for floater
J16
TR60-H recorder, 115-002795-00
J19
Indicator board, 051-001857-00
HEAT-TEMP:
J27
Preheating
bath
temperature detection
DIL-TEMP: Diluent temperature detection
Protective earth wire
Pump
HT: Connect the heating rod
TS: Connect the temperature relay
Liquid
009-004360-00
Diluent heating unit, 115-025649-00
Power supply unit and middle partition
connecting
Soldered to the BNC connector
cable
RBC signal
No.: HXQ-19001-New 3-DIFF
J29
RBC bath
Version: 1.0
IVD Global Technical Support Dept.
009-004370-00
009-004372-00
WBC signal wire
Component
ground
wire
009-004368-00
HGB signal wire
009-007651-00
Small LCD screen
signal cable
009-004655-00
009-007650-00
Connecting cable of
small touch screen
Connecting cable of
LCD screen
009-004366-00
Connecting cable of
touch screen
No.: HXQ-19001-New 3-DIFF
J30
/
WBC bath
Sampling assembly, syringe assembly,
one wire for each motor
J28
HGB indicator
J24/J25
Connecting cable of 8.4-inch screen
J26
Connecting cable of 8.4-inch touch screen
J24/J25
Connecting cable of 10.4-inch screen
J26
Connecting cable of 10.4-inch touch
screen
Version: 1.0
IVD Global Technical Support Dept.
Appendix E
Model
Product Model
Inspection
No.
Item
NO.
Inspection
Item
Alignment Confirmation Table
SN
SN
Description
Description
Result
Result
Conclusion
Conclusion
Refer
to
the
attached related
image files
□OK □NG
□PASS □FAIL
12
Electrical
connection
Safe and
grounding
13
Beep
/
With beep
□OK □NG
□PASS □FAIL
14
Time and Date
Time and Date
Time and date are
correct
□OK □NG
□PASS □FAIL
15
Version
Correct version
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
No bubbles
□OK □NG
□PASS □FAIL
No fluid drop
□OK □NG
□PASS □FAIL
Normal
position
when the sample
probe is in the
down position
□OK □NG
□PASS □FAIL
Bubble
exist
mixing
□OK □NG
□PASS □FAIL
Bubble
exist
mixing
□OK □NG
□PASS □FAIL
No overflow and
no contact
□OK □NG
□PASS □FAIL
No overflow and
no contact
□OK □NG
□PASS □FAIL
Normal emptying
□OK □NG
□PASS □FAIL
Normal emptying
□OK □NG
□PASS □FAIL
Tighten
screws;
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
16
17
Confirm
mechanical
positions
Confirm
mechanical
positions
Detect
18
Counting Lane
reliable
Requirement
Requirement
Version
and
configuration
information
Confirm the relative
position of the sample
probe and the WBC
Confirm the relative
position of the sample
probe and the RBC
Do air bubbles exist in
the sampling tubes?
Does
fluid
drop
suspend on sample
probe tip
Is the sample probe
below the liquid level
and is it contact with
the counting bath?
Does bubble mixing
exist in the WBC
bath?
Does bubble mixing
exist in the RBC bath?
Is
there
overflow
during WBC bubble
mixing?
Do
the
bubbles touch the
pipette?
Is
there
overflow
during RBC bubble
mixing?
Do
the
bubbles touch the
pipette?
Is emptying WBC
counting bath normal?
Is emptying RBC
counting bath normal?
Install the shielding
box of the counting
bath.
Sample probe action
Sample probe tubes
19
Analyzer
Maintenance
Perform maintenance
and cleaning
No.: HXQ-19001-New 3-DIFF
Refer
to
the
Mechanical
Alignment section
Refer
to
the
Mechanical
Alignment section
the
No
interference
during action of
sample probe
The
sampling
tubes
do
not
interfere with other
structures
Refer to the user
manual
Version: 1.0
IVD Global Technical Support Dept.
20
Background
Count
WBC
RBC
HGB
HCT
PLT
≥ 0.20×10 /L
≥ 0.02×1012/L
Print properly
□OK □NG
□PASS □FAIL
No error messages
or alarms
Date:
□OK □NG
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
□PASS □FAIL
9
≤ 1g/L
≤ 0.50%
≥ 5×109/L
21
Recorder
Print the test result
22
Shutdown
Shutdown
Tested by:
Appendix F Installation Checklist
No.
NO.
1
2
3
4
5
6
7
No.
NO.
1
2
3
4
5
7
No.
NO.
1
2
3
4
No.
Inspe
ction
Item
Ambient
Description
Description
Inspection
Item
temperatur
Humidity
Envir
eAtmosphe
onm
ric
ent
Electromag
Pressure
RequSpacenetic
irem Requirements
Powerinterferenc
Supply
e
ents Requirements
Tube Models
Inspe
ction
Item box
The package
Within the normal
operation
Within operating
temperature
humidity
range
Within
operating
atmospheric
Keep away from
pressure
theSpace
electromagnetic
Power supply
interference
voltage
andmeet
The tubes
source
frequency
the specifications
Description
Package and
appearance
Items
in the
waste
Connection
of
diluent
Connection of
the
The Hemolysis
position of
Solution
diluent container
Inspe
ction
Item
Analyzer
Inspection
Item
temperature
Voltage and
current
Reagent Setup
Result
□Pass
□Fail
20%～85%
□Pass
□Fail
70KPa～106KPa
□Pass
□Fail
/
□Pass
□Fail
Meet the space
requirements
Meet
the
□Pass
□Fail
□Pass
□Fail
requirements
of
Meet the
Table
2-2
requirements
of
□Pass
□Fail
Reference
Package
and
appearance
All items are
sound
included
Tube
properly
package
Waste
tube and
sensor
Waste tube and
Result
Reference
10℃～35℃
section
2.4
Refer
ence
Description
Inspection
and
appearance
Item ListItem of
the main
unit
Connection
of
Maintenance
Refer
ence
Result
Result
□Pass
□Fail
□Pass
□Fail
□Pass
□Fail
connected
and not
Tube properly
bent
connected
and not
Tube properly
□Pass
□Fail
sensor
Connection of
□Pass
□Fail
bent
Hemolysis
connected
and
not
The relative
Not lower than 1 □Pass
□Fail
Solutionofbag
bentm
position
thecap
assembly
diluent
container to
Description
Refer
Result
the main
unit
ence
Description
Result
Reference
Temperature
Meet the
□Pass
□Fail
valuesand
Voltages
currents
Reagent barcode
requirements
Meet
the
requirements
Set correctly
and
lotsettings
numberof
The
information
the maintenance
setup
Description
Satisfy the
customer's
demand
Value
□Pass
□Fail
□Pass
□Fail
□Pass
□Fail
Description
Refer
ence
1
Inspe
ction
Item
WBC
Reference
≤ 0.20
 109/L
□Pass
□Fail
2
Inspection Item
RBC
≤ 0.02 1012/ L
□Pass
□Fail
3
Back
HGB
≤ 1 g/L
□Pass
□Fail
4
grou
HCT
≤ 0.5 %
□Pass
□Fail
5
nd
PLT
≤ 5  109/L
□Pass
□Fail
NO.
No.: HXQ-19001-New 3-DIFF
Version: 1.0
Vallue
Result
Result
IVD Global Technical Support Dept.
6
WBC
≤2.0%
□Pass
□Fail
7
Repeat
RBC
≤1.5%
□Pass
□Fail
8
ability
HGB
≤1.5%
□Pass
□Fail
MCV
≤0.5%
□Pass
□Fail
PLT
≤4.0%
□Pass
□Fail
/
/
□Pass
□Fail
9
10
11
(WB)
Result
accuracy
/
(WB)
No.: HXQ-19001-New 3-DIFF
Version: 1.0