BC-5150/BC-500
0
AUTO HEMATOLOGY
ANALYZER
SERVICE
MANUAL
Introduction
Before starting to service this instrument, please read this manual thoroughly for proper service.
After reading this manual, make sure it is well kept so that it is available when needed.
Product Name: Auto Hematology Analyzer Model: BC-5150/BC5-5000 Registered Address: F1-4,
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen
Production Address: Building A3, Honghualing Industrial Park, Liuxian Road, Nanshan, Shenzhen
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns
the intellectual property rights to this manual and the relevant product.
© 2012 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any
manner whatsoever without the written permission of Mindray is strictly forbidden.
,
are registered trademarks or trademarks owned by Mindray.
Microsoft Corporation owns the copyright of SQL SERVER 2005 EXPRESS EDITION. ©2005
Microsoft Corporation. All rights reserved.
Statement
Mindray is responsible for safety, reliability and performance of this product only in the condition
that:
∎ all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
∎ all replacement parts and supporting accessories and consumables involved in the
service are original Mindray parts or Mindray authorized parts;
,
,
I
∎ the relevant electrical installation complies with the applicable national requirements;
∎ the product is operated in accordance with this service manual.
Repair Service
Free Service: Free service is provided for any product within the scope specified by
Mindray warranty rules. Paid Service:
∎ Mindray offers paid service for any product beyond the scope specified by Mindray
warranty rules;
even during the warranty period, only paid service is available if the need for service is
caused by the following reasons: artificial damage; improper use; grid voltage beyond the
specified range of the device; irresistible natural disasters; replacement with parts and
consumables not authorized by Mindray or service work by personnel not authorized by
Mindray.
Return Procedure
In the event that it becomes necessary to return this product or part of this product to
Mindray, the following procedure should be followed::
∎ Obtain return authorization: Contact the Mindray Service Department and obtain a
Customer Service Authorization (Mindray) number. The Mindray number must appear on
the outside of the shipping container. Returned shipments will not be accepted if the
Mindray number is not clearly visible. Please provide the model number, serial number,
and a brief description of the reason for return.
∎ Freight policy: The customer is responsible for freight charges when shipping the
product to Mindray for service (including customs charges).
Company Contact
Manufacturer:: Shenzhen Mindray Bio-Medical Electronics Co.,
Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan,
Shenzhen
Postal Code: 518057
Website: www.mindray.com
24-hour Service Hotline: 4007005652
Phone: +86 755 81888998
Fax: +86 755 26582680
II
● This manual is only provided for qualified service personnel trained by Mindray
or Mindray's agents.
● This system is only intended for use by qualified service personnel trained by
Mindray or Mindray's agents.
● It is important for the hospital or organization that employs this equipment to carry
out a reasonable service/maintenance plan. Neglect of this may result in
machine breakdown or injury of human health.
● Be sure to operate the analyzer under the situation specified in this manual; otherwise,
the analyzer will not work normally and the analysis results will be unreliable,
which would damage the analyzer components and cause personal injury.
III
Table of Contents
1 Overview .................................................................................................................... 1-1
1.1 Overview ..................................................................................................................... 1-1
1.2 Who Should Read This Manual .................................................................................. 1-1
1.3 How to Find Information ............................................................................................ 1-1
1.4 Conventions Used in This Manual .............................................................................. 1-2
1.5 Special Terms Used in This Manual ............................................................................ 1-2
1.6 Symbol ........................................................................................................................ 1-4
2 Specifications ............................................................................................................. 2-1
2.1. Product Name .............................................................................................................. 2-1
2.1.1 Physical Specifications ....................................................................................... 2-2
2.1.2 Electrical Specifications ..................................................................................... 2-2
2.1.3 Environment Requirements ................................................................................ 2-3
2.1.4 Specifications ..................................................................................................... 2-3 2.2.
Testing Parameters ...................................................................................................... 2-3 2.3.
Performance Requirements ......................................................................................... 2-5
2.3.1 Background/Blank Count ................................................................................... 2-5
2.3.2 Carryover ........................................................................................................... 2-5
2.3.3 Repeatability ...................................................................................................... 2-6
2.3.4 Linearity Range .................................................................................................. 2-7 2.4.
Display Range ............................................................................................................. 2-8 2.5.
Product Description ..................................................................................................... 2-8
Main unit ................................................................................................................... 2-12
Power/Status indicator............................................................................................... 2-12
Power switch ............................................................................................................. 2-12
[Aspirate] key ............................................................................................................ 2-13
USB port ................................................................................................................... 2-13 2.6.
Product Configuration ............................................................................................... 2-13 2.7.
Reagents, Controls and Calibrators ........................................................................... 2-13
2.7.1 Reagents ........................................................................................................... 2-14
2.7.2Reagent Consumption Volume ....................................................................................
2-14 2.7.3 Controls and Calibrators................................................................................... 2-15
2.8. Information Storage Capacity ................................................................................... 2-15
3 Operation Principles ................................................................................................. 3-1
3.1 Overview ..................................................................................................................... 3-1
3.2 Workflow..................................................................................................................... 3-1
3.3 Sample aspiration ........................................................................................................ 3-2
3.4 White Blood Cell Measurement .................................................................................. 3-2
Laser flow cytometry .................................................................................................. 3-2
1
Table of Contents
3.5 Hemoglobin Concentration Measurement...................................................................
3-3 Colorimetric method ...................................................................................................
3-3 Hemoglobin concentration parameters
........................................................................ 3-3 Impedance method
...................................................................................................... 3-3 Time
Measurement ...................................................................................................... 3-4 Red
blood cell parameters ........................................................................................... 3-4
Platelet parameters ......................................................................................................
3-5 3.6 Parameter Flags
............................................................................................................... 3-6
4 Software and Interface.............................................................................................. 4-1
4.1. Start-up ........................................................................................................................ 4-1
Version Check ............................................................................................................. 4-1 4.2.
Login ........................................................................................................................... 4-2
4.2.1 Log in using service level username and password............................................ 4-2
4.2.2 Login Check ....................................................................................................... 4-2 4.3.
Review ........................................................................................................................ 4-4
4.3.1 Stability Trend Graph ......................................................................................... 4-4
4.3.2 Trend Graph ....................................................................................................... 4-5 4.4.
Calibration ................................................................................................................... 4-5
4.4.1 Calibration Factor and Transfer Factor .............................................................. 4-5
4.4.2 Calibration .......................................................................................................... 4-7 4.5.
Sample Probe Debug ................................................................................................... 4-8
4.6. Temperature Calibration .............................................................................................. 4-8
4.7. Gain Calibration .......................................................................................................... 4-9
4.8. Gain Setting ................................................................................................................4-11
4.9. Performance .............................................................................................................. 4-12
4.9.1 Background test ................................................................................................ 4-12
4.9.2 Reproducibility ................................................................................................. 4-13
4.9.3 Carryover ......................................................................................................... 4-14
4.9.4 Reference range of normal samples ................................................................. 4-14
4.10. Advance Toolbox ......................................................................................................
4-15 4.10.1 System Configuration .....................................................................................
4-15 4.10.2 One-key Export ..............................................................................................
4-16 4.11. Software Update
........................................................................................................ 4-17 4.12. Status Indicator
.......................................................................................................... 4-18 4.13. Buzzer
....................................................................................................................... 4-18
5 Data Transmission ..................................................................................................... 5-1
5.1. LIS Connection ........................................................................................................... 5-1
5.2. Data Management Software Setup ..............................................................................
5-3 5.3. Communication Error Analysis ...................................................................................
5-4 5.3.1 Physical Connection ........................................................................................... 5-4
5.3.2 Communication Setup ........................................................................................ 5-4
5.3.3 Network Firewall ............................................................................................... 5-4
2
Table of Contents
6 Optical System ........................................................................................................... 6-1
6.1. Introduction to the Principles of Optical System ........................................................ 6-1
6.1.1 Operation Principles ........................................................................................... 6-1
6.1.2 Beam Path of the Optical system ....................................................................... 6-2 6.2.
Physical Structure ........................................................................................................ 6-2
6.2.1 Overall Structure ................................................................................................ 6-2
6.2.2 Light Source Assembly ...................................................................................... 6-4
6.2.3 Flow Cell Assembly ........................................................................................... 6-4
6.2.4 Optical Substrate Assembly ............................................................................... 6-5
6.2.5 Preamplifier and Shield Shell ............................................................................. 6-5
6.2.6 Shield Shell Assembly ........................................................................................ 6-6
6.2.7 Scattering Detection Assembly .......................................................................... 6-6
6.2.8 Laser Control Board ........................................................................................... 6-7 6.3.
Determinating the Optical System Status .................................................................... 6-7 6.4.
Maintenance and Replacement of the Optical System ................................................ 6-9
6.4.1 Maintenance of the Optical System.................................................................... 6-9
6.4.2 Replacement of the Optical System ................................................................. 6-14
7 Fluidics ....................................................................................................................... 7-1
7.1. Measurement Flow ...................................................................................................... 7-1
7.1.1 WBC&HGB Channel ......................................................................................... 7-2 7.1.2
RBC/PLT Channel .............................................................................................. 7-4 7.2.
Sample Volume ........................................................................................................... 7-4 7.3.
Temperature of Fluidics .............................................................................................. 7-5 7.4.
Reagent Consumption Volume .................................................................................... 7-5 7.5.
Introduction to Fluidic Parts ........................................................................................ 7-6
7.5.1 Mindray Valves .................................................................................................. 7-6
7.5.2 2-way Mindray Pressure-proof Valve ................................................................. 7-6
7.5.3 LVM Fluidic Valve ............................................................................................. 7-7 7.5.4
Pinch Valve ......................................................................................................... 7-7 7.5.5
Liquid Filter ....................................................................................................... 7-8 7.5.6
Syringe Linkage ................................................................................................. 7-9 7.5.7
Electromagnetic Metering Pump ........................................................................ 7-9 7.5.8
preheat bath ...................................................................................................... 7-10 7.5.9
Vacuum Pump ...................................................................................................7-11 7.5.10
Sample Probe ................................................................................................. 7-12 7.5.11
Probe Wipes .................................................................................................... 7-12 7.5.12
Hydraulic pressure sensor .............................................................................. 7-13 7.5.13
1-way Valve .................................................................................................... 7-14 7.5.14
Baths ............................................................................................................... 7-14 7.6.
Detailed Introduction of Fluidic Structure ................................................................ 7-14 7.6.1
Sampling and dispensing channel .................................................................... 7-15 7.6.2
WBC&HGB Channel ....................................................................................... 7-15 7.6.3
RBC/PLT Channel ............................................................................................ 7-17
3
Table of Contents
7.6.4 Precautions for Assembly and Service ............................................................. 7-18
7.7. Introduction to Sequences .........................................................................................
7-19 7.7.1 Measurement sequence in WB-CBC+DIFF mode ...........................................
7-19 7.7.2 Measurement sequence in PD-CBC+DIFF mode ............................................
7-32 7.7.3 Measurement sequence in CBC
mode.............................................................. 7-33 7.7.4 Introduction to the Maintenance
Sequences ..................................................... 7-33
8 Hardware System ...................................................................................................... 8-1
8.1. Hardware System Overview........................................................................................ 8-1
8.1.1 Functional Block Diagram ................................................................................. 8-1 8.1.2
Electrical Connection Block Diagram ................................................................ 8-2 8.1.3
System Troubleshooting ..................................................................................... 8-2 8.2.
Digital Control Board .................................................................................................. 8-4
8.2.1 Overview ............................................................................................................ 8-4
8.2.2 Components........................................................................................................ 8-4
8.2.3 Adjustment and Tests ......................................................................................... 8-8
8.2.4 Troubleshooting.................................................................................................8-11 8.3.
Analog Drive Board .................................................................................................. 8-15
8.3.1 Overview .......................................................................................................... 8-15
8.3.2 Components...................................................................................................... 8-15
8.3.3 Sockets and Indicators ...................................................................................... 8-19
8.3.4 Troubleshooting................................................................................................ 8-23 8.4.
Power Board .............................................................................................................. 8-26
8.4.1 Overview .......................................................................................................... 8-26
8.4.2 Replacement and Connection ........................................................................... 8-27
8.4.3 Troubleshooting................................................................................................ 8-27 8.5.
Optical Boards ........................................................................................................... 8-28
8.5.1 Optical Path and Optical System Workflow ..................................................... 8-28
8.5.2 Functions of Optical Boards ............................................................................. 8-29
8.5.3 Troubleshooting................................................................................................ 8-31 8.6.
Touchscreen Drive Board .......................................................................................... 8-33
8.6.1 Overview .......................................................................................................... 8-33
8.6.2 Components...................................................................................................... 8-33
8.6.3 Troubleshooting................................................................................................ 8-33 8.7.
Indicator Board ......................................................................................................... 8-34
8.7.1 Overview .......................................................................................................... 8-34
8.7.2 Components...................................................................................................... 8-34
8.7.3 Troubleshooting................................................................................................ 8-35 8.8.
Motor, Photocoupler and Microswitch ...................................................................... 8-35 8.8.1
Overview .......................................................................................................... 8-35 8.8.2
Troubleshooting................................................................................................ 8-36 8.9.
Liquid sensor board ................................................................................................... 8-37
8.9.1 Overview .......................................................................................................... 8-37
8.9.2 Composition ..................................................................................................... 8-37
4
Table of Contents
8.9.3 Troubleshooting................................................................................................
8-37
9 Heating System .......................................................................................................... 9-1
9.1. Heating System Overview ........................................................................................... 9-1
9.2. Heating System ........................................................................................................... 9-1
9.2.1 Diluent Heating System ..................................................................................... 9-1
9.2.2 Optical heating system ....................................................................................... 9-3
10 Mechanical System .................................................................................................. 10-1
10.1. Mechanical System Overview ...................................................................................
10-1 Front view ................................................................................................................. 10-1
Back view .................................................................................................................. 10-2 Left
view ................................................................................................................... 10-4 Left view
................................................................................................................... 10-6 10.2.
Components .............................................................................................................. 10-6
10.2.1 Introduction .................................................................................................... 10-6
10.2.2 Overall ............................................................................................................ 10-7
10.2.3 Main unit ........................................................................................................ 10-8
10.2.4 Panel Module (BC-5150) ............................................................................. 10-12
10.2.5 Panel Module (BC-5000) ............................................................................. 10-13
10.2.6 Syringe Assembly ......................................................................................... 10-14
10.2.7 Sample Probe Assembly ............................................................................... 10-15
10.2.8 RBC count pool module ............................................................................... 10-16
10.2.9 HGB count pool module .............................................................................. 10-17
10.2.10 Pump Assembly .......................................................................................... 10-18
10.2.11 Power Backplane Assembly ....................................................................... 10-18
10.2.12 Optical System ........................................................................................... 10-20
10.2.13 Power Assembly ......................................................................................... 10-21
10.3. Removal and Installation .........................................................................................
10-21 10.3.1 Tools .............................................................................................................
10-21 10.3.2 Preparation for Disassembly ........................................................................
10-21 10.4. Disassembling the Main Unit
.................................................................................. 10-22 10.4.1 Removing the Back plate
............................................................................. 10-23 10.4.2 Removing the Analog drive
board PCBA .................................................... 10-23 10.4.3 Removing the Pinaster board or
the SD card ............................................... 10-24 10.4.4 Removing the power backplate
Assembly ................................................... 10-25 10.4.5 Removing the Fan Assembly
........................................................................ 10-26 10.4.6 Removing the Right
Panel............................................................................ 10-26 10.4.7 Removing the RBC
count pool module(FRU) ............................................. 10-27 10.4.8 Removing the Ruby Red
Cell Counter(D50um) .......................................... 10-28 10.4.9 Removing the HGB amp
module ................................................................. 10-29 10.4.10 Removing the Liquid detect
board PCBA .................................................. 10-31 10.4.11 Removing the Reagent Bottle
plate cosmetic piece ................................... 10-31 10.4.12 Removing the preheat Assembly
................................................................ 10-32
5
Table of Contents
10.4.13 Removing the Electromagnet Pinch Valve Assembly ................................
10-33
10.4.14
Removing
the
Right
Valve
Assembly
......................................................... 10-34 10.4.15 Removing the Pump
................................................................................... 10-35 10.4.16 Removing the
Vacuum Chamber Assembly ............................................... 10-36 10.4.17
Removing the Top Cover ........................................................................... 10-36
10.4.18Removing the Temperature detection assembly ..........................................
10-37
10.4.19
Removing
the
Sampling
Probe
Assembly
.................................................. 10-37 10.2.20 Replace the Horizontal Motor of the
Sampling Probe Assembly ............... 10-38 10.4.21 Replace the Vertical Motor of
the Sampling Probe Assembly ................... 10-39 10.4.22 Removing the Probe
wipe .......................................................................... 10-39 10.4.23 Replacing the
Sample Probe ...................................................................... 10-40 10.4.24
Removing the Syringe Motor Position Sensor ........................................... 10-41
10.4.25 Removing the transducer discreteness .......................................................
10-42
10.4.26
Removing
the
Panel
Module
...................................................................... 10-43 10.4.27 Removing the
Indicator board PCBA ........................................................ 10-43 10.4.28
Removing the 6301 touch control board PCBA ......................................... 10-44
10.4.29 Removing the Touch Panel .........................................................................
10-45
10.4.30
Removing
the
LCD
Module
....................................................................... 10-46 10.4.31 Removing the
Microswitch Assembly ....................................................... 10-46 10.4.32
Removing the Syringe ................................................................................ 10-47
10.4.33 Removing the Syringe Motor .....................................................................
10-48 10.3.34 Removing the Syringe Motor Position Sensor Assembly
.......................... 10-49 10.4.35 Removing the liquid detect assembly
......................................................... 10-49 10.4.36 Removing the Electromagnetic
Pump/Valve from the Front Panel ............ 10-50 10.4.37 Removing the Left Door
Assembly ............................................................ 10-51 10.4.38 Removing the
Optical System .................................................................... 10-52 10.4.39
Removing the Optical System Cover ......................................................... 10-52
10.4.40 Replacing the RBC/WBC Isolation Chamber Filter ..................................
10-52
10.4.41
Replacing
the
Power
Board
PCBA
............................................................ 10-53
11 Troubleshooting ........................................................................................................ 11-1
12 Debug........................................................................................................................ 12-1
12.1 Mechanical Position Adjustment .................................................................................
12-1 12.2 Commissioning of detection elements
........................................................................ 12-2 12.2.1 Calibrate and verify the preheat
temperature ................................................. 12-2 12.2.2 Counting channel measurement
.................................................................. 12-3
13 Commissioning and Verification After Servicing ................................................. 13-1
14 Service BOM ............................................................................................................ 14-1
15 Appendices ............................................................................................................... 15-1
6
Table of Contents
A. Fluidic diagram ........................................................................................................ A-1
B. Connection and Tube ................................................................................................ B-1
C. Hardware block diagram ......................................................................................... C-1
D. Cables and Wires ...................................................................................................... D-2
E. Appendix Table .......................................................................................................... E-1
7
1 Overview
1.1 Overview
This chapter describes how to use the service manual. In this manual, the repair methods of
BC-5150/BC-5000 are described in detail. Before servicing BC-5150/BC-5000, please carefully read
and understand the content in order to properly carry out equipment maintenance and ensure the
safety of service personnel.
This manual must be used in conjunction with the BC-5150/BC-5000 Operator’s manual. It does not
contain information and procedures already covered in the Operator’s manual of BC-5150/BC-5000.
● 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
To use this manual effectively, you need to have the following capacities:
● Comprehensive knowledge of electric circuit and fluidic system;
● Comprehensive knowledge of reagents;
● Comprehensive knowledge of quality control;
● Thorough understanding of troubleshooting;
● The ability to operate the analyzer skillfully
● The ability to use basic mechanical tools and understand related terminology;
● The ability to use a digital voltmeter and an oscilloscope masterly;
● And the ability to read pneumatic/hydraulic schematics and understand related terminology.
1.3 How to Find Information
This manual contains 14 chapters and 4 appendices. Refer to the table below to find the information
you need. If you want to ... See ...
BC-5150/BC-5000's physical specifications Chapter 2 Specifications BC-5150/BC-5000's
parameters, respective ranges and test principle
Chapter 3 Operation Principles
interface introduction and upgrading of BC-5150/BC-5000's software
Chapter 4 Software and Interface
1-1
Overview
BC-5150/BC-5000's external interface settings Chapter 5 Data Transmission learn about the optical
system of BC-5150/BC-5000's and its maintenance methods
1-2
Chapter 6 Optical System
composition, dosage, basic channels and time sequence of BC-5150/BC-5000's fluidic system
Chapter 7 Fluidic System
BC-5150/BC-5000's hardware structure; composition, commissioning and testing point and
troubleshooting of each board
Chapter 8 Hardware System
BC-5150/BC-5000's heating principle Chapter 9 Heating System BC-5150/BC-5000's error and
troubleshooting Chapter 10 Troubleshooting BC-5150/BC-5000's structure, disassembly and
verification
Chapter 11 Mechanical System
Debug after BC-5150/BC-5000 being serviced Chapter 12 Debug Debug and verification after
BC-5150/BC-5000 being serviced
Chapter 13 Debug and Verification After Servicing BC-5150/BC-5000's service BOM Chapter 14
Service BOM BC-5150/BC-5000's fluidic diagrams Appendix A Fluidic Diagrams
BC-5150/BC-5000's fluidic tube connectors Appendix B Lists of tube
connectors BC-5150/BC-5000's hardware diagrams Appendix C Hardware
Diagrams BC-5150/BC-5000's cables and wires Appendix D Cables and Wires
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 BC-5150/BC-5000 ×× italic letters indicate titles of the chapters that are referred
to
All illustrations in this manual are provided as examples only. They may not necessarily reflect your
analyzer setup or data displayed.
1.5 Special Terms Used in This Manual
You will find the following symbols in this manual.
When you read ... It means ...
WARNING
● It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of
human health.
● Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the
analyzer. Otherwise, the risk of explosion may exist.
● When servicing the analyzer, be sure to turn off the power. Servicing the analyzer when it is on
may bring risk of electric shock or damage to electronic components.
● Please connect the analyzer to a socket having sole fuse and protective switch. Do not use the
same fuse and protective switch with other equipment (e.g. life supporting equipment). Otherwise,
the equipment failure, over current or impulse current that occurs at the startup moment may lead to
tripping.
● To prevent personal injury during the maintenance, keep your clothes, hairs and hands from the
moving parts, such as sample probe, pincher and piercer.
● Possible mechanical movement of the warned position may lead to personal injury during normal
operation, removal and service verification.
● Be sure to dispose of reagents, waste, samples, consumables, etc. according to government
regulations.
WARNING
CAUTION
read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or
unreliable analysis results.
read the statement below the symbol. The statement is alerting
NOTE
you to information that requires your attention.
● All the substances (samples, controls, calibrators, reagents and liquid wastes) and areas in
contact with these substances are potentially infectious. Wear proper personal protective equipment
(e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when accessing these substances
and areas in the laboratory.
● In the event of main unit leak, the leaking fluid is biohazardous.
Overview
read the statement below the symbol. The statement is alerting you to a potentially biohazardous
condition.
read the statement below the symbol. The statement is alerting you to an operating hazard that can cause
personnel injury.
1-3
CAUTION
● Improper maintenance may damage the analyzer. Maintain the analyzer strictly as
instructed by the service manual and inspect the analyzer carefully after the
maintenance.
● For problems not mentioned in the service manual, contact Mindray customer
service department for maintenance advice.
● To prevent personal injury or damage to equipment components, remove metal jewelry
before maintaining or servicing electronic components of the equipment.
● Electrostatic discharge may damage electronic components. If there is a possibility of
ESD damage with a procedure, then do that procedure at an ESD workstation, or wear an
antistatic wrist strap.
NOTE
● The operator is required to follow the instructions below this symbol. The
instructions will emphasize important information or information that
requires particular attention of the operator.
1.6 Symbol
Symbols used in this service
manual:
Symbol Meaning
● The reagents are irritating to eyes, skin and diaphragm. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them in the laboratory.
● If the reagents accidentally spill on your skin, wash them off with plenty of water and if
necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them
off with plenty of water and immediately go see a doctor.
WARNING
CAUTION
is required to follow the instructions
Overvimbol. Failure to do so may place the
potential risk of biohazard. The operator
follow the instructions below this symbol.
so may cause personal injury.
or damage of the product or affect the test
he operator is required to follow the instructions
elow this symbol. Failure to do so may cause
1-4
he operator.
he operator is required to follow the instructions below
is symbol. The instructions will emphasize important
formation or information that requires particular
NOTE
The analyzer system may contain the following
symbols:
CAUTION
● Ensure the labels are in good condition and not damaged while servicing the
analyzer.
When you see... It means...
Overview
CAUTION, CONSULT ACCOMPANYING
DOCUMENTS. Note: It is recommended
that the reader refers to the
accompanying documents for important
safety information. BIOLOGICAL RISK
WARNING, LASER BEAM
PROTECTIVE EARTH (GROUND)
USB port
Network interface
ALTERNATING CURRENT
FOR IN VITRO DIAGNOSTIC USE
Batch code
Overview
USE BY (YYYY-MM-DD)
Serial number
MEASUREMENT AUTHORIZATION
SYMBOL
DATE OF MANUFACTURE
Pricking danger
Manufacturer
TEMPERATURE LIMITATION
CONSULT INSTRUCTIONS FOR USE
The device fully complies with requirements
of EU IVD Directive 98/79/EC
This electronic product contains certain
toxic substances, and has an Environmental
Protection Use Period (EPUP) of 20 years.
It can be used safely during the EPUP, but
shall be recycled after the EPUP.
2 Specifications
2.1. Product Name
∎ Name: Auto Hematology Analyzer
∎ Model: BC-5150/BC-5000
∎ BC-5150 Appearance
∎ BC-5000 Appearance
2-1
2.1.1 Physical Specifications
Height
Depth
Width
Table 2-1 Dimensions and weight
BC-5150/BC-5000
Overall
Dimensions
Width ≤ 325 mm
Height ≤ 435 mm (rubber feet
included)
Depth ≤ 410 mm
Weight ≤25Kg
2.1.2 Electrical Specifications
Table 2-2 Main unit power supply
Parameter Value
Voltage (100V-240V~) ±10%
Input Power ≤300VA
Frequency 50/60±1Hz
Specifications
● Only fuses of specified specification shall be used.
Fuse Specification: 250V 3.15A D5X20
2.1.3 Environment Requirements
Operating environment, storage environment and running environment
Table 2-3 Overall environment requirements
Operating Environment
Requirements
Storage Environment
Requirements
Running Environment
Requirements
10°C~30°C -10°C~40°C 10°C~35°C
Ambient Temperature
Relative Humidity
20%~85% 10%~90% 10%~90%
Atmospheric
70kPa~106kPa 50kPa~106kPa 70kPa~106kPa
Pressure
2.1.4 Specifications
Measurement mode
Two measurement modes are provided: CBC and CBC+DIFF.
Sample mode
Three sample modes are provided: whole blood mode, prediluted mode and Capillary Whole
Blood mode.
Each of the three sample modes can be used in both CBC and CBC+DIFF measurement mode.
Measurement speed
BC-5000's testing speed for OV-WB/OV-PD/OV_PWB modes is not lower than 40 samples
per hour.
BC-5150's testing speed for OV-WB/OV-PD/OV_PWB modes is not lower than 60 samples
per hour.
2.2. Testing Parameters
The analyzer provides quantified results for 25 report parameters and 4 research parameters(as
shown in the table below), 3 histograms and 1 scattergram, and 2 measurement modes (CBC and
CBC+DIFF).
Parameter Series English Name Abbreviation CBC CBC + DIFF
Specifications
2-3
Specifications
White Blood Cell count WBC √ √ Basophils number Bas# / √ Basophils percentage Bas% / √ Neutrophils number
Neu# / √ Neutrophils percentage Neu% / √ Eosinophils number Eos# / √ Eosinophils percentage Eos% / √
Lymphocytes number Lym# / √ Lymphocytes percentage Lym% / √
Monocytes number Mon# / √ Monocytes percentage Mon% / √
Abnormal Lymphocytes
ALY# / √
number
Abnormal Lymphocytes
percentage
2-4 ALY% / √
Large Immature Cells
number White blood cell parameters (15 items), including 4 research parameters
LIC# Large Immature Cells
LIC% / / √ √
percentage
Red blood cell parameters (8 items)
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 √ √
parameters (6 items)
Platelet
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 √ √ √ √ √ √ √ √ √ √ √ √
Histogram
English Name Abbreviation CBC CBC + DIFF White Blood Cell Histogram WBC Histogram √ √ Red Blood Cell
Histogram RBC Histogram √ √
● “√”means available in this measurement mode, and “/”means not available in this
measurement mode.
● ALY%, LIC%, ALY# and LIC# are research parameters which are only intended for
research purpose and can not serve as basis for clinical diagnosis. For more
information on research parameters, please refer to 5.2.2 General Settings
Research Parameters.
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 for 3 times in a row, the highest value among the 3
results shall meet the requirements in the following table.
Table Table Table Table 2-4 Background/blank count
requirements Background/blank count requirements
Background/blank count requirements
Background/blank count requirements
Parameter Background/blank count requirements
WBC
RBC
HGB
HCT
PLT
≤ 0.20× 109
/L
≤ 0.02× 1012
/L
≤1g/L
≤ 0.5 %
≤ 10 × 109
/L
2.3.2 Carryover
Carryover refers to the transfer of blood cells from high concentration sample to low
concentration sample.
Verification method: Prepare a high concentration sample (centrifugated high value control or
Platelet Histogram PLT Histogram √ √
Scattergram
Name Abbreviation CBC CBC + DIFF Differential Scattergram Diff Scattergram /
√
Specifications
special high value linearity control) which is within the range specified in Table 13, mix and then test it for 3
consecutive times, 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 13, test it for 3 consecutive times,
the test results are j1, j2 and j3. Calculate the carryover according to the following equation, the result
shall meet the requirements in Table 12.
Table Table Table Table 2-5 Carryover Carryover Carryover Carryover Requirements Requirements
Requirements Requirements Parameter Carryover
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
HCT ≤0.5%
PLT ≤1.0%
Table Table Table Table 2-6 6 6 6 Sample Sample Sample Sample Concentration Concentration
Concentration Concentration Range Range Range Range of of of of Carryover Carryover Carryover
Carryover Test Test Test Test Parameter Unit High concentration
range
Low concentration range WBC ×109/L > 15.00 < 3.00 RBC ×1012/L > 6.00 < 2.00 HGB g/L > 200 < 40
HCT ×109/L > 54% <18% PLT ×109/L > 300 < 100
2.3.3 Repeatability
Test a sample which meets repeatability requirement on the analyzer for 10 consecutive times,
calculate the CV(%) and absolute deviation (d) of each parameter, 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;
x
i
---- actual test result of the sample;
d ---- absolute deviation of the sample test results.
Specifications
2-6
Specifications
Table 2-7 Whole Blood Repeatability Requirements
Parameter Condition Whole Blood
Repeatability
(CV/absolute
deviation d)
2.3.4 Linearity Range
Linearity was determined by running diluted samples. 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 Table Table Table 2-8 Linearity Linearity Linearity Linearity Requirements Requirements
Requirements Requirements 2-7
Predilute
Repeatability
(CV/absolute
deviation d) WBC
4.00×109
/L~15.00× 109 /
L
≤2.0% ≤4.0%
Neu% 50.0%~70.0% ±4.0(d) ±8.0(d)
Lym% 20.0%~40.0% ±3.0(d) ±6.0(d)
Mon% 5.0%~10.0% ±2.0(d) ±4.0(d)
Eos% 2.0%~5.0% ±1.5(d) ±2.5(d)
Bas% 0.5%~1.5% ±0.8(d) ±1.2(d)
3.50 × 1012
RBC
/LL
~ 6.00 × 1012 /
≤1.5% ≤3.0%
HGB 110 g/L ~ 180 g/L ≤1.5% ≤3.0%
MCV 70 fL~120 fL ≤1.0% ≤2.0%
100 × 109
PLT
/ L ~ 149 × 109 / L ≤6.0% 150 × 109 / L ~ 500 × 109 / L ≤4.0% ≤10.0% ≤8.0%
MPV / ≤4.0% ≤8.0%
Parameter Linearity Range Deviation Range (Whole
Blood)
Deviation Range
(Predilute)
WBC 0.00 × 109/L~ 100.00
×109/L
(for both BC-5000 and
BC-5150)
±0.30×109/L or ±5% ±0.60×10 9/L or ±6%
100.01 × 109/L ~
500.00×109/L
(for BC-5150 only)
±10% ±12%
Specifications
RBC 0.00×1012/L~8.00×
±0.05×1012/L or ±5% ±0.10×10 12/L or ±10%
1012/L
HGB 0 g/L~250g/L ±2g/L or ±2% ±4g/L or ±4%
PLT 0 × 109/L ~ 1000 ×
109/L
(for both BC-5000 and
BC-5150)
2-8 ±10×109/L or ±8% ±20×10 9/L or ±16%
1001×109/L ~ 5000×
109/L
(for BC-5150 only)
±12% ±20%
HCT 0%~67% ±2% (HCT value) or
±3% (deviation percent)
±4%(HCTvalue) 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. Display Range
Table Table Table Table 2-9 Display Display Display Display Range Range Range Range Parameter
Display Range
WBC 0.00×109/L~999.99×109/L
RBC 0.00×1012/L~18.00×1012/L
HGB 0 g/L~300g/L
PLT 0×109/L~9999×109/L
HCT 0%~80%
2.5. Product Description
∎ BC-5150 AUTO HEMATOLOGY ANALYZER composed mainly of analysis unit, information
management unit, output unit and accessories.
∎ The illustrations in this manual are based on BC-5150. The structures of BC-5000 and BC-5150 are
basically the same.
Specifications
● This analyzer is heavy and may cause personal injury if handled by only one person. If
necessary, it is recommended to use two person for handling the analyzer. It is
important to follow appropriate safety rules and use appropriate tools while
handling.
2-9
Figure 2-1 Front view of the main unit
1 ---- [Aspirate] key 2 ---- Sample probe
3 ---- Power/Status indicator 4 ---- Display
2-10
Figure 2-2 Back view of the main unit
1 --- M-52D diluent inlet 2 --- Waste outlet
3 --- Waste sensor 4 --- Power input socket
5 --- Power switch
Specifications
Figure 2-3 Left view of the main unit
1 --- Access door 2 --- Panel Module
3 --- Left door assembly 4 --- Network interface and USB port
Main unit
The machine for analysis and data processing is the main part of the
product.
Power/Status indicator
The Power/Status indicator is located in the middle of the right side of the analyzer (front
side). It tells you about the status of the analyzer including ready, running, error, sleep
and on/off, etc.
Power switch
The power switch is located on the rear side of the main unit. This switch can be used
to turn on/off the main unit.
● To avoid damage, do not turn on/off the power of the analyzer continually in a
short time.
Specifications
[Aspirate] key
The [Aspirate] key is located on the middle of the right front side (the right one). You can
press the key to start the selected analysis cycle, dispense diluent or wake up the system
from sleep USB
port
There are 4 USB ports on the left side of the main unit for peripheral connection or data
transmission.
2.6. Product Configuration
The system configuration is composed mainly of main analyzer unit, accompanying
accessories and reagent system. The user can choose an optional external
scanner/printer.
The USB port can be used to connect the following printer models: EPSON LQ-590K,
HP Laser Jet P1505n, HP Office Jet Pro K5300, and HP LaserJet P1606dn.
2.7. 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
should only use the 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 there is evidence of leakage or improper handling, do not use the
reagent.
Specifications
● Store and use the reagents as instructed by instructions for use of the
reagents.
● When you have changed the diluent, lyses or cleansers, 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.
2-13
Specifications
2.7.1 Reagents
M-52 D DILUENT
Used for diluting the blood samples to achieve functions such as blood cell counting, volume
measurement and hemoglobin measurement.
M-52 DIFF LYSE
Used for lysing red blood cells to categorize quartile groups of white blood cells.
M-52 LH LYSE
Used for lysing red blood cells to achieve functions such as white blood cell counting, classification
of basophils and hemoglobin measurement.
PROBE CLEANSER
Used for cleansing the instrument regularly.
2.7.2Reagent Consumption Volume
Table 2-10 3107 reagent volume
Sample Mode
Diluent
(ml)
2-14 DIFF Lyse (ml) LH Lyse (ml) Probe cleanser
(ml)
CD 27.5 1 0.2 0
CD 27.5 1 0.2 0
CD 27.6 1 0.2 0
Whole Blood Mode CBC 23.2 0 0.2 0
Capillary Blood Mode CBC 23.2 0 0.2 0
Prediluted Mode CBC 22.9 0 0.2 0
Shutdown 60.9 1 0.2 2
Normal Startup 65 1 0.2 0
Exit Standby 1 3.7 0 0 0
Exit Standby 2 16.9 0 0 0
Exit Standby 3 65 3 0.2 0
Specifications
2.7.3 Controls and Calibrators
The controls and calibrators are used for calibration and quality control of the analyzer. The control
is an industrial whole blood product, used for monitoring and evaluating the accuracy of the
hematology analyzer. They are available in low, normal, and high levels. The control is also an
industrial whole blood product, used for the calibration of this analyzer to establish metrological
traceability for measurement results. For use and storage of controls and calibrators, please refer to
the instructions for use of the controls and calibrators.
All references related to controls and calibrators in this manual refer to the controls and calibrators
specifically formulated for this analyzer by Mindray.
2.8. Information Storage Capacity
3. Table 2-11 Data storage requirements
Storage Capacity
2-15 BC-5000's storage capacity of sample data is not less than 20000 BC-5150's storage capacity
of sample data is not less than 40000 Storage Contents
The storage contents shall include at least the following information: counting results and diagrams
(including histograms and scattergrams), sample information, patient information, alarm message,
special information of the instrument
3 Operation Principles
3.1 Overview
This analyzer employs Coulter principle to test the number of RBC and PLT, colorimetric
method to measure the hemoglobin concentration, and semiconductor laser flow
cytometry to obtain differential statistics of white blood cells. The analyzer will calculate
the other parameters based on these results.
3.2 Workflow
The whole system contains the following main functions: reagent system, sample allocation,
sample preparation, sample testing, signal processing, parameter analysis, data
management, status monitoring, scheduling control and information processing, human
machine interface, power supply, cleaning and maintenance. The relationship between
these functions are as shown in the chart below.
The scheduling control and information processing function block controls other function
blocks, which collaborate in accordance with the designed processes and requirements
to
3-1
Figure 3-1 White blood cell
measurement
After the blood sample is mixed by the lyse, the red blood cells will be lysed, and the white
blood cells will be dyed. Through the sample probe, the dyed fragments of white blood cell
and red blood cell are injected into the flow cell, which is filled with the diluent. Wrapped in
the sheath fluid formed by the diluent, the cells go through the laser detection zone in rows
after a secondary acceleration. When the cells are exposed to laser beam, the scattered
light is related to the cell size and the refractive index of both the cell membrane and the
internal structure. These scattered light signals are received and converted into electrical
pulses by the photodiode. From these electrical pulses, a two-dimensional distribution map
of the cell size and internal information and be obtained, which is called a scattergram.
From the WBC scattergram and histogram, the white blood cell differential and count can
be obtained.
complete the core task of the whole system, i.e. sample measurement and
analysis.
3.3 Sample aspiration
he analyzer will aspire 15μL (in CBC+DIFF mode) or 11.5μL (in CBC mode) of whole
blood sample in the OV-WB mode.
In OV-PD mode, the operator shall mix 20 μL of capillary blood sample and 480 μL of
diluent outside the analyzer to obtain a diluted sample with the dilution ratio of 1:25,
and send this diluted sample to the analyzer. In this event, the analyzer will aspirate
200 μL of diluted sample.
3.4 White Blood Cell Measurement
Laser flow cytometry
Operation Principles
Operation Principles
3.5 Hemoglobin Concentration Measurement
Colorimetric method
After the diluted sample is added into the lyse, the red blood cells will lyse and release hemoglobin,
which combines the lyse to form hemoglobin complexes. According to the Lambert-Beer's law, with
the radiation of LED monochromatic light with a central wave length of 530 nm, it is possible to
measure the transmitted light density of the hemoglobin complexes in the solution and background,
by which the hemoglobin concentration can be calculated.
Hemoglobin concentration parameters
The concentration of hemoglobin (HGB) in g/L can be calculated from the following equation.
=×
 
Sample
Photocurre nt 3-3 HGB(g/L)
Constant Ln Blank Photocurre nt
 
Red blood cell/Platelet measurement
Impedance method
This analyzer employs the impedance method to count the RBC/PLT. There is a small opening in
the RBC bath, which is called inspection aperture. A pair of electrodes on both sides of the aperture
are connected to a constant current power supply. Since the cells are poor conductor of electricity,
when the cells in the diluted sample pass through the aperture under a constant negative pressure,
the resistance between the electrodes changes to generate a pulse signal across the electrodes,
which is proportional to the cell size. The number of the pulses is equal to the number of cells that
pass the aperture, and the amplitude of the pulses is proportional to the cell size.
Figure 3-2 The counting principle
The collected electric pulses are amplified and then compared with the channel voltage
threshold corresponding to the size range of normal red blood cells/platelets, in order to
calculate the number of the pulses which amplitude are within the red blood cell/platelet
channel. Therefore, the collected electric pulses are classified according to the channel
voltage threshold. The numbers of the electric pulses within the red blood cell/platelet
channel are the numbers of the red blood cells/platelets. The size distribution of the cells
is determined by the numbers of the cells in each channel, which are classified according
to the pulse voltage amplitude. The two-dimensional diagram, in which the horizontal axis
represents the cell size and the vertical axis represents the relative number of the cells,
are the histogram that reflects the distribution of the cell groups.
Time Measurement
The basis of time measurement is under certain vacuum pressure and with
fixed aperture dimension, the sample volume passes through the aperture within
a certain period of time is definite. Thus analysis results can be obtained by
calculating sample volume from analysis duration, dilution ratio, etc. And
analysis accuracy can be ensured by controlling vacuum generating process
and monitoring real-time vacuum pressure and aperture voltage.
Monitor and determine clogging: by monitoring aperture and sample particle
information, relevant characteristic information is concluded, and the judgment is
made in combination with the threshold.
Red blood cell parameters
∎ Red blood cell counts
Operation Principles
Operation Principles
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes passing
through the aperture.
∎ Mean red blood cell volume
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and expresses
the result in fL.
Hematocrit, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows, where the RBC is
expressed in 1012/L, MCV in fL and HGB in g/L.
where the RBC is in 1012/L, the MCV is in fL, and the HGB is in g/L.
∎ The coefficient variation of the red cell distribution width
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation, %) of the
erythrocyte distribution width.
∎ The standard deviation of the red cell distribution width
RDW-SD (RBC Distribution Width – Standard Deviation, fL) is obtained by calculating the standard
deviation of the red blood cell size distribution.
Platelet 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).
∎ Platelet distribution width
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size
distribution. Each PDW result is derived from the platelet histogram data and is reported as
10(GSD).
∎ Plateletcrit
3-5 HCT
=
RBC
× MCV
10
MCH = HGB RBC
MCHC =
HGB HCT
× 100
Operation Principles
This analyzer calculates the PCT as follows and express it in %, where the PLT is expressed in
109/L and the MPV in fL.
where the PLT is in 109/L and the MPV is in fL.
3.6 Parameter Flags
3.6.1 Flags
The following table lists all 22 flags and their indications.
Type Flag
Flag Meaning Judgment criterion
Interference of PLT clump or NRBC to WBC count and differential may exist:
WBC
3-6
1. The DIFF and BASO WBC Abnormal
channels are unproportionate.
Immature cells or blasts may
Immature Cell?
exist
Many scatter-points in the immature cell area of the scattergram
Abn./Atypical Lym?
Abnormal Many atypical exist.
lymphocytes lymphocytes may or
abnormal/ lymphocytes scatter-points area in the atypical of the scattergram
Leucopenia Low WBC analysis results WBC < 2.50×10^9/L
Leucocytosis High WBC analysis results WBC > 18.00×10^9/L
Low neutrophils
analysis
Neutropenia
results
NEUT# < 1.00×10^9/L
Neutrophilia
High neutrophils
results
analysis
NEUT# > 11.00×10^9/L
Lymphopenia
Low lymphocytes
results
analysis
LYMPH# < 0.80×10^9/L
Lymphocytosis
High lymphocytes
results
analysis
LYMPH# > 4.00×10^9/L
Monocytosis
High monocytes
results
analysis
MONO# > 1.50×10^9/L
Eosinophilia
High eosinophils
results
analysis
EO# > 0.70×10^9/L
Basophilia High basophils analysis results BASO# > 0.20×10^9/L
Pancytopenia WBC, RBC and PLT low
Wbc < 4.0×10^9/L and Rbc < 3.5×12^9/L and Plt < 100 ×10^9/L
Possible presence of
RBC RBC Histogram Abn.
microcytes, macrocytes,
The distribution of RBC
histogram is abnormal
Operation Principles
anisocytosis, RBC agglutination and dimorphic histogram
HGB abnormal or RBC HGB Abn./Interfere?
agglutination, or interference may exist (e.g., WBC high)
3-7
MCHC > 380 g/L or HGB interference
Microcytosis MCV low Mcv < 70fL
Macrocytosis MCV high Mcv > 110fL Anemia Anemia HGB < 90g/L
Erythrocytosis RBC high RBC > 6.5×10^12/L
PLT
Possible presence of microcytes, red blood cell debris, giant PLT or PLT clump
The distribution of PLT
scattergram is abnormal
Thrombopenia PLT low PLT < 60×10^9/L
Thrombocytosis PLT high PLT > 600×10^9/L
3.6.2 Shielding Protocol
See the following table for the shielding relations of each flag.
Flag Type
Flag Shielding Relation
WBC
PLT Scattergram Abn.
WBC Abnormal R/?Flag parameter: WBC, related DIFF parameters
Immature Cell? R/?Flag parameter: Neu%#, Mon%#, Bas%#.
Abn./Atypical Lym?
R/?Flag parameter: Lym%#, Mon%#, Bas%#, etc. Differ slightly based on the situation.
Leucopenia /
Leucocytosis /
Neutropenia /
Neutrophilia /
Lymphopenia /
Lymphocytosis /
Monocytosis /
Eosinophilia /
Basophilia /
Pancytopenia /
RBC
RBC Histogram Abn.
R/?Flag parameter: RBC, HCT, RDW-CV, RDW-SD, etc.
Position of the “?” differs slightly based on the situation.
HGB Abn./Interfere? R/?Flag parameter: HGB, MCH, MCHC.
Microcytosis /
Macrocytosis /
Operation Principles
Anemia /
Erythrocytosis /
PLT
3-8 PLT Scattergram Abn. R/?Flag parameter: PLT, MPV, PDW, PCT, PLCR, PLCC, etc.
/
Thrombopenia
Thrombocytosis
/
3.6.3 Sensitivity Adjusting Mechanism
The sensitivity adjusting mechanism allows adjustment of flag rate to meet the needs of all hospitals
(see “Flag alarm sensitivity” in the Operator’s Manual).
4 Software and Interface
4.1. Start-up
Version Check
At startup, the machine will automatically check the software version. If the software
version
does not match, a window will pop up as shown
below:
Figure 4-1The software version match window Please prepare the
software upgrade package, select the appropriate language and click the “OK” button.
The system will perform the software upgrade progress.
Detection of unmatched software version at startup is caused by upgrading individual
software component, such as digital version FPGA chip writing software, drive board
FPGA writing software, MCU writing software, sequence and system software.
∎ Always use controlled software upgrade package for software
upgrade.
4-1
4.2. Login
4.2.1 Log in using service level username and password
Username: "Service" Password: "Se s700"(there is a
space between Se and s700).
∎ The login password is case sensitive.
4.2.2 Login Check
After login with service level password, the machine will automatically check the board
backup
data and SD card data. If any board or SD card has been changed, or abnormal shutdown
occurs after
configuration, a recovery or backup operation of the instrument data will be prompted after login
with
service level password.
Figure 4-2Login check prompt window Click “OK” to enter the Data
Backup and Recovery screen, and perform data backup and recovery according to the
prompts.
Software and Interface
Figure 4-3 Data Backup and Recovery
screen
1) If a new SD card is replaced, please follow the subsequent text guide and select
“Restore” to
restore the important parameters to the SD
card.
2) If the MPU is replaced, please follow the subsequent text guide and select “Backup” to
back
up the data in the new MPU.
3) If abnormal shutdown occurs after configuration has been changed, please select
“Backup” to
back up the data in the new MPU.
Software and Interface
Figure 4-4 Stability trend graph screen
The stability and the limit of the RBC and PLT particles are considered to be 15% of the
mean
by default; the stability and limit of other particles are considered to be 10% if the mean by
default;
the limits of the fluids pressure, RBC aperture voltage, HGB voltage and vacuum in the
vacuum
chamber are considered to be 10% of the mean by
default.
The limit can be set manually; the data length is 6
digits; If the limit is larger than the mean, the total low
limit is 0.
4.3. Review
4.3.1 Stability Trend Graph
Software and Interface
Figure 4-5 Trend Graph
Screen
If the mean of the parameter can be gained by calculation of the selected data, then the
y-axis of
mean central line, upper limit data line, lower limit data line are as follow by default: Mean,
Mean +
Mean * 10%, Mean – Mean * 10%;
If the results of the “Mean+ deviation” do not meet the requirements of the data format of
the
parameter, then obtain the y-axis of the upper and lower data line by the rounding-off
principle.
If the limit is larger than the mean, set the low limit as
0;
If the upper limit exceeds the parameter display range, click the “OK” button, the “OK”
dialog
box will prompt”The upper limit exceeds the parameter display range, please
reset”.
4.4. Calibration
4.4.1 Calibration Factor and Transfer Factor
The purpose of calibration is to obtain accurate blood analysis
results.
The calibration method is multiplying the result by the calibration factor, so that the
final
analysis result is close to the target. The calculation equation of the calibration
factor is:
4.3.2 Trend Graph
Software and Interface
There are two different sample modes, whole blood mode and prediluted mode, which
also
correspond to different fluidics sequence. Therefore, different sample modes need to be
calibrated
separately.
The calibration factors can be classified as factory calibration factor and user calibration
factor.
For the CBC+DIFF mode, the analysis result will be calculated by the following
equation:
Analysis result=measurement value × factory calibration factor × user calibration factor
For the CBC mode, the analysis result will be calculated by the following
equation:
Analysis result=measurement value × factory calibration factor × transfer factor × user
calibration factor
The calibration will only generates calibration factors and transfer factors of five
traceable
parameters: WBC, RBC, HGB, MCV and PLT.
There are two different analysis modes, CBC+DIFF and CBC. The two analysis
modes
respectively correspond to two fluidics sequence. Therefore, the analysis results of the same
sample in
different modes are different. However, this difference is relatively fixed. During calibration, it
is
only required to obtain the calibration factor of one mode. The calibration factor of the other
mode
can be calculated by multiplying this fixed difference coefficient, which is called the transfer
factor.
The calculation equation of the transfer factor
is:
Software and Interface
∎ If login with service level password, the calibration will modify the factory
calibration factor and transfer factor, and will modify the user calibration
factor to 100.00%.
4-6
Figure 4-6Service level calibration
screen
The service level calibration with calibrators will generate the factory calibration factor
and
transfer factor at a time. The first 6 counts are performed in CBC+DIFF mode, and the last 6
counts
are performed in CBC mode. After all the 12 counts are completed, the new calibration factor
and
transfer factor will be automatically calculated. The operator will be prompted to save the
calibration
factor when exiting this screen.
Before the calibration, be sure to set up the Calibrator Lot No., the Calibrator Exp.
Date,
Analysis Mode and Calibration Targets.
The range of Calibration factor is [0/75, 1.25]. .
4.4.2 Calibration
∎ Please use specified calibrators for calibration before their expiration
date.
Software and Interface
∎ If the calibration factor and CV are beyond the above range, they will be displayed
in
red, and the current result will not be
saved.
4-7
4.5. Sample Probe Debug
The purpose of sample probe debug is to check if the probe can move to each working
position
properly.
Figure 4-7Sample probe debug
screen
Enter the sample probe debug screen and click the “Initial position” button. Wait until
the
initialization is completed before start the sample probe debug. For detailed information, please
refer
to Section 12.1 “Mechanical position debug” in Chapter
12.
4.6. Temperature Calibration
The purpose of temperature calibration is to minimize the difference between the
measurement
and the actual temperature in order to ensure the accuracy of sample
analysis.
Software and Interface
Figure 4-8Temperature calibration screen
There are four quantities in this screen: total difference, new difference, machine
measurement
value and meter measurement value. This screen does not include one quantity: the
actual
measurement value, which is the actual temperature measured by the temperature sensor.
These
quantities satisfy the following equation:
New difference = Meter measurement value – Actual measurement
value
After clicking “Save”, the new difference is assigned to the total difference: Total
difference =
New difference Machine measurement value = Actual measurement value + Total
difference
4.7. Gain Calibration
Gain calibration includes gain calibration of the optical channel, the impedance channel
and
HGB. The purpose of optical channel gain calibration is to ensure the accuracy of the
algorithm
categorization, and the purpose of impedance channel and HGB gain calibration is to ensure
accurate
values of MCV and HGB to be calculated. If the scattergram is normal but there is no
categorization
results or obvious deviation in the categorization results, check the optical system or
recalibrate the
optical gain. If the HGB background voltage in the status screen is beyond the range,
recalibrate the
HGB gain.
Software and Interface
Figure 4-9 Service level calibration screen
The optical gain, MCV gain and HGB gain can be calibrated simultaneously in the
Gain
Calibration screen. As a software gain, the optical gain can be calibrated by mean method.
Selecting
the “Select” box of the single count to involve this count in the mean calculation. As hardware
gains,
the MCV gain and the HGB gain can be calibrated by successive approximation, and the
“Select” box
has no effect on the results of the MCV gain and HGB
gain.
Whether the gain calibration is successful is marked by color. Unsuccessful calibration
result
will be displayed in red, which means a recalibration is
necessary.
If a target has not been set up, then the corresponding gain factor will not be
calibrated, as
G.S. MCV in the figure above.
Note: The G.S. MCV target is not the same as MCV calibration target, they are not
the
same value.
When exiting the Gain Calibration screen, the operator will be prompted whether to
save the
gain factor.
Software and Interface
∎ Only calibration with calibrators is supported in the Gain Calibration screen.
4-10
∎ Please use specified calibrators for gain calibration before their expiration
date.
∎ For the targets, please refer to the calibrator target
sheet.
4.8. Gain Setting
The optical gain, MCV gain and HGB gain can be set up in the Gain Setting screen. The
purpose
of gain setting and gain calibration is the same. Gain setting can be considered as
manual gain
calibration.
Figure 4-10 Gain Setting screen
The optical gain is a software gain and shall be filled with the gain factor, which can
be
calculated by the following equation:
The gain factor is a percentage value. The Gain Setting screen allows the gain factor to be
set as
accurate to two decimal places.
The MCV gain and HGB gain are software gains, which require the digital potentiometer
to be
set. The range of gain setting is [0, 255].
The MCV gain setting can be calculated by the following
equation:
Software and Interface
The HGB gain setting does not need to be calculated by an equation. Just
modify the
setting until the background voltage is equal to
4.5V.
∎ The gain settings will have effect on the affectivity of the measurement. Please be careful
with the setting.
∎ While the analyzer is in standby, the HGB voltage will not reflect the background voltage. In
this event, the operator must exit the standby mode before adjusting the HGB gain.
4.9. Performance
4.9.1 Background test
Figure 4-11 Background Count screen
In the Background Count screen, pressing the aspirate key without using any sample will
start
the background count. In the Background Count screen, if “pass” is displayed in the Result
column,
Software and Interface
Figure 4-12 Reproducibility Test screen
Select the samples that satisfy the reproducibility range and perform 10
consecutive
measurements on the analyzer. Calculate the CV (%) or absolute deviation d of each
measured
parameter and check if the reproducibility requirement is
met.
then the background test is
passed.
4.9.2 Reproducibility
Software and Interface
∎ Normal controls are usually used for reproducibility application at the client
end.
4-13
Figure 4-13 Carryover Test screen
Test method: Under the stable condition of the analyzer, perform three consecutive measurements
on the high-level sample immediately followed by three consecutive measurements on the low- level
sample. The carryover can be calculated from the following equation:
T - level-high sample result -T level-low sample result 100 % (%) = First level-low sample result hird
result Carryover T hird level-low sample hird × Advanced Toolbox
4.9.4 Reference range of normal samples
Parameter Mean
Deviation
Range NEU_LAS_P 139.91 6.01 NEU_MAS_P 123.87 9.84 NEU_WAS_P 39.40 4.80
NEU_EQWIDTH_P 14.57 0.30 NEU_LAS_CV(%) 6.83 3.15 NEU_MAS_CV(%) 12.95 2.35
NEU_WAS_CV(%) 20.88 2.35 NEU_EQWIDTH_CV(%) 1.12 0.65
4.9.3 Carryover
Software and Interface
4-14
4.10. Advance Toolbox
4.10.1 System Configuration
Figure 4-14System Configuration screen
In the System Configuration tab of the advanced toolbox, you can modify the language
type, the
analyzer serial No. and data type to be
saved.
After the “Save inf file” option is selected, the inf file will be saved to
directory
/mnt/hd/soft/dat/rawdata. The inf files save the analyzer status and sample analysis
data for
diagnostics of analyzer performance.
After the “Save raw data” option is selected, the dat file will be saved to
directory
/mnt/hd/soft/dat/dat. The dat files save the raw pulse signals collected by the MPU
FPGA for
diagnostics of analyzer performance.
Software and Interface
∎ The modification to language type will not take effect until after the analyzer is
restarted.
∎ The saved inf files and raw data files will occupy relatively large amounts of
disk
(SD card) space.
4-15
∎ At most 500 inf files can be saved. After 500 files are saved, the new files
will
overwrite the old files.
4.10.2 One-key Export
Figure 4-15One-key Export screen
The contents that can be exported by One-Key operation
include:
∎ Inf files
∎ Special information files
∎ Analyzer information: includes version information, configuration parameter (gain and
calibration), algorithm parameters, analyzer status, software language and analyzer
name
∎ Software debug information: includes parameter setting, error log, upgrade log and
system
log.
∎ Closed-reagent information: includes closed-reagent information and counter
information
Software and Interface
∎ The USB flash drive has been pre-formatted as FAT32.
∎ The following USB drive models are recommended: Kingston 8/16G, SanDisk
8/16G,
4-16
Maxell 4/8G.
∎ There is enough free space in the USB drive. It is recommended to reserve 4G
space.
4.11. Software Update
∎ Create an upgrade USB drive
● Unzip update.rar and copy the unzipped “update” directory to the root directory of the
USB drive.
∎ The USB flash drive has been pre-formatted as FAT32.
∎ The directory structure of USB drive: the root directory contains a directory
named
update, which contains two directories: step1 and
step2.
∎ Upgrade
● Insert the USB drive into the USB port on the analyzer. Enter the Advanced Toolbox and
launch Upgrade to upgrade the software according to the prompts. The upgrade process
can be divided into two steps.
● Step 1: upgrade the guidance and operation system,
● Step 2: upgrade the software components.
● When upgrading the boot and operation system, the operator will be prompted to
restart the analyzer between step 1 and step 2. When upgrading the software
components, the upgrade process will directly go to step 2.
∎ Never disconnect the USB drive or the power supply during the upgrade
process.
Otherwise the analyzer may not be able to
start.
Software and Interface
∎ The duration of the upgrade process varies with the upgrade contents. Typically
it
will last for around 10 minutes. Interaction is needed during the process.
Please do not leave when upgrading the analyzer.
4-17
Software and Interface
∎ Troubleshooting
● If the upgrade fails, try again.
4.12. Status Indicator
The system status is indicated by the three color indicator on the panel door. All the flash cycles
are 2 seconds. The indicator changes with the analyzer status as shown in the table below:
Table 4-1 Indication of the main unit status indicator
Analyzer Status Indicator Comments
Ready Green light on Sequence is allowed
Running Green light flashing Sequence is being performed
Running with error Red light flashing An error is present and the
system is running
Stop with fault Red light on An error occurs and the
system is not running
No fault is present, but
fluidics action is not
allowed
4-18 Yellow light on Initialization and standby
status of sequence is not
involved in the startup
process
Enter/Exit standby
status
Yellow light flashing Enter/Exit standby status
4.13. Buzzer
When an error occurs, the buzzer will beep. The alarm will be automatically cleared by tapping
the touchscreen or correcting the error. The buzzer alarm will stop when all the error are cleared. It
prompts to instruct the user with possible actions by the beep.
Table 4-2 Main unit buzzer prompts
Event Buzzer
Prompts
Comments
Startup completed One short beep Startup completed means the
whole startup process has been
completed and the analyzer is
ready for operation
Open-vial aspiration completed Two short beeps
When count operation can not be One long beep If these screens have already
Software and
started in count related
screens
prompted, then the buzzer
need
(including Sample Analysis, QC,
not be responded again.
Calibration, Reproducibility,
Carryover, Background, Aging and
Optical Gain Calibration Count, etc.),
press the aspirate key
Error Long intermittent
bee
4-19
Tap the touchscreen to stop
the
buzzer
Analyzer is ready One short beep Analyzer enters ready status
from other status
When the screen is black prompting
“Please power off the analyzer”
Silence If an error occurs during the
shutdown process, the
buzzer
black
5 Data Transmission
5.1. LIS Connection
● Communication setup (“Menu”>“Setup”>“System Setup”>“Communication Setup”)
The operator can perform the following setups in the “Communication Setup”
screen
● Protocol setup
● Transmission mode
5-1
Figure 5-1 Communication Setup
screen
● Protocol setup
IP address:
The IP address setting of the analyzer defaulted as 10.0.0.2
Subnet mask:
The subnet mask of the analyzer. A typical subnet mask is 255.255.255.0
Default gateway:
IP address of the gateway. Mac
address:
The Mac address of the analyzer, given by the factory. Can not be changed.
Comm. Protocol:
For selecting the protocol type. Click the pull-down list and select the appropriate
communication protocol type from the options.
∎ The IP address of the analyzer is statically allocated. Before setup, please
consult
your network administrator to avoid IP conflict.
∎ For communication across subnets, the subnet mask and the gateway must be
correct.
Please consult your network
administrator.
● Transmission mode
The operator can select required options by clicking the following checkboxes to
activate corresponding communication setup as needed:
● Auto retransmit
The “Auto retransmit” can only be selected when the “ACK synchronous
transmission” is selected, if ACK is not selected after overtime, the software
will transmitted the content that has transmitted before automatically.
● Auto communication
If it is selected, the software will transmit the sample information and count result to
the LIS automatically after the sample analysis.
● Transmit as print bitmap data
If it is selected, the scattergram and histogram that transmitted to the LIS are the same as
the print graph, whose background are white.
● Transmission method for histograms and scattergrams
Click the pulldown list and select the transmission method for histograms and
scattergrams as required from the following options:
● Not transmitted
If it is selected, the graphic and image data will not be
transmitted.
● Bitmap
If it is selected, the image data will be transmitted, all the scattergram and
histogram of the LIS received are bitmap.
● Data If it is selected, the graph data will be transmitted during the transmission,
the scattergram and histogram that LIS received is the data, the data format is
customized; it can only be viewed by the Mindray data management software.
ACK synchronous
transmission:
This function can be activated by selecting the “ACK synchronous transmission”
checkbox.
When this function is active, the ACK overtime is defaulted as “10” seconds. The
operator can adjust this value in the edit box.
Data Transmission
5.2. Data Management Software Setup
Communication parameter setup
Figure 5-2 Communication Parameter Setup screen for data management software
As illustrated above, IP Address refers to the analyzer IP address, Port is fixed as 5100,
and Protocol shall match the analyzer configuration.
Communication instrument management
Data Transmission
Figure 5-3 Communication Instrument Management screen for data management software
The analyzer is the server, and the LIS and data management software is the client. The
connection needs to be initiated by the client.
5.3. Communication Error Analysis
5.3.1 Physical Connection
Check if the network cable works properly and if the physical network connections are
correct.
5.3.2 Communication Setup
Check if the network setup is correct, including the communication setup of the analyzer
and LIS.
5.3.3 Network Firewall
Please open the network connection license of LIS and data management software,
and open the network connection license of port 5100 to check for the firewall.
Data Transmission
Figure 6-1 Laser scatter principle
Since the sample stream has a certain width, different cells will pass the beam zone at
slightly
different positions. In order to ensure the consistency of cell scatter signals, the Gaussian
beam shall
has a certain width in the direction perpendicular to the cell movement to minimize the
density
variation of the beam coving the sample stream, as shown in Figure 6-1. Meanwhile, in
order to
prevent the beam from radiating several cells at the same time, the beam shall be small
enough in the
direction of the cell movement, just being able to cover the entire cell. Therefore, the beam
used for
radiating the sample stream shall be an elongated elliptical
beam.
6 Optical System
6.1. Introduction to the Principles of Optical System
6.1.1 Operation Principles
The basic principle of optical system is the employment of flow cytometry-based laser
scattering
method. As shown in Figure 6-1, wrapped in the diluent sheath, the processed and diluted
blood
forms a sample stream carrying cells. This sample stream becomes very thin due to the
focusing
effect of the sheath, forcing the cells to flow one by one through the center of the chamber
with a
certain space between each other. Elongated elliptical Gaussian beam goes through the optical
zone of
the flow cell, irradiates individual cells to generate scattered light, which is received by the
detector
and transformed into photoelectric signals necessary for cell counting and
categorizing.
6-1
6.1.2 Beam Path of the Optical system
As a component of the optical path, the optical zone of the flow cell is the zone that the
laser
beam passes which are shown as
follows:
Light source assembly: Beam shaping function component, which shapes the divergent
elliptical
beam generated by the semiconductor laser to elongated beam and directs it into the
flow cell.
Flow cell assembly: Both an optical component and a fluidic component. As the fluidic
interface
of the optical system, it provides stable sample streams. The optical performance of this
component is
also critical. Dirt, contamination or dust in the optical zone on the inside and outside surface
of the
flow cell may have great impact on the performance of the optical
system.
Scattering detection assembly: consists of aperture and photoelectric sensor. Used for
collecting
the scattered light generated by the cells. There are three photoelectric sensors in the optical
system
for collecting scattered light of three angle ranges, including Low Angle Scatter (LAS),
Medium
Angle Scatter (MAS) and Wide Angle Scatter (WAS).
Figure 6-2 Optical path diagram of the optical
system
The relative positional relationship between the three parts of the optical path is
achieved by
precise commissioning and fastening with special instruments, and therefore is not field
serviceable.
6.2. Physical Structure
6.2.1 Overall Structure
The overall structure of the optical system is shown in Figure 6-3. According to
different
functions, the system can be divided into the following
parts:
Optical System
Figure 6-3 Overall structure model of the optical
system
1 ---Light source assembly 2 ---Flow cell assembly
3 ---Substrate assembly 4 ---Preamplifier and shield shell
5 ---Shield assembly 6 ---Scattering detection assembly
7 ---Laser control board
Optical System
Figure 6-4 Physical structure of the optical
system
6-3
Figure 6-5 Light source assembly
6.2.3 Flow Cell Assembly
The flow cell assembly is the fluidic interface of the optical system. The fluidics are turned
into
stable sheath stream under the pressure of the shield fluid bath. After reaction, the cells are
injected
by the sample syringe into the flow cell assembly and are wrapped by the sheath. Then the
cells go
through the flow cell one by one for laser irradiation, as shown in Figure
6-6.
6.2.2 Light Source Assembly
The light source assembly is used for providing light source output and beam shaping
for the
optical system, as shown in Figure 6-5. Both the removal of internal parts of the light source
assembly
and the removal of the assembly from the substrate are forbidden. Generally, if the light
source
assembly is determined to be faulty, the whole optical system shall be
replaced.
(a) Physical view of the flow cell assembly (b) Operation principle of the flow cell
Optical System
Figure 6-6 Flow cell assembly
Both the removal of internal parts of the flow cell assembly and the removal of the
assembly
from the substrate are forbidden. Generally, if the flow cell assembly is determined to be
faulty, the
whole optical system shall be replaced.
6.2.4 Optical Substrate Assembly
The substrate assembly provides support, fixation and shock absorption for the optical
system, as
shown in Figure 6-7. The screws in the substrate assembly is not removable. If loose screws
result in
abnormal condition of the optical system, please replace the whole optical
system.
Figure 6-7 Optical substrate
assembly
6.2.5 Preamplifier and Shield Shell
The preamplifier and shield shell are used for pre-amplifying the optical system signals
and
shielding signal noise. The preamplifier is connected by the preamplifier shield shell with the
optical
system shield shell. If the preamplifier is determined to be faulty, it is possible to remove and
replace
it from the optical system, as shown in Figure
6-8.
Optical System
Figure 6-8 Preamplifier and shield shell
6.2.6 Shield Shell Assembly
The shield shell is used for isolating the optical system from the outside to avoid
interference of
dust, stray light and electromagnetic noise, and for connecting the optical system to the
analyzer, as
shown in Figure 6-9.
Figure 6-9 Shield shell assembly
6.2.7 Scattering Detection Assembly
As the detection unit of the optical system, the scattering detection assembly
consists of
medium/small angle PD and large angle PD and corresponding medium/small angle
aperture and
Optical System
large angle aperture and support structure. The 3D model and physical view are shown in Figure
6-10.
The scattering assembly is a whole unit and can not be removed from the optical substrate,
although
the large angle PD assembly is removable. When the scattering detection assembly is
determined to
be faulty, it is necessary to replace the whole optical
system.
Figure 6-11 Las 6.3.
Determinating the Optical
System Status
When abnormal sample scattergram causes failed or incorrect categorization, and the
reagent and
fluidic connections are determined to be normal, it will be necessary to check the optical
system
status. In this section, the optical system status is tested with standard particles. Prior to
the test,
prepare the following items:
Consumables: 4k-07 Std. part. (7μm) and 1.5 mL centrifuge tube, slobe
cleanser.
The detailed procedure is as follows.
1. First, add 0.5 mL of deionized water to a 1.5mL centrifuge tube. Shake the 7 μm
std.
Figure 6-10 Scattering detection
assembly
6.2.8 Laser Control Board
The laser control board is used for providing stable driving current for the laser to keep a full
and
stable laser output power, as shown in Figure 6-11. If the laser control board is determined
to be
faulty, it is possible to remove and replace it from the optical
system.
Optical System
Figure 6-12 Preparation of the 7μm std. part. solution
2. Select the Maintenance menu and enter the “Optical” screen. Perform counting with
the prepared std. part. solution. After the counting is completed, the result will be automatically
displayed in the screen, as shown in Figure 6-13. 3. Determine the optical system status by the
parameter Particle 1 according to the
counting result. The optical system is OK if all the following requirements are met:
Parameter Total CG Position CV
LAS
1500~3000
38~45 ≤6.50 MAS 100~158 ≤3.00 WAS 100~200 ≤8.00 4. Generally, if the parameters fail to meet
the requirements, it may be caused by a dirty
flow cell. The built-in maintenance program can be used to solve this problem. The method is as
follows: click the “Maintenance-->Maintenance” menu and select “Flow Cell Cleaning” in the
“Cleaning” screen. The machine will automatically complete the cleaning operation (in about 1
minute).
After the maintenance, repeat step 2 and 3 and check if the result meets the requirements. If not,
probe cleanser should be used to clean the flow cell: click the “Maintenance-->Maintenance” menu
and select “Overall Soak” in the “Maintenance” screen, and carry out the operation of the program.
After the maintenance above, repeat step 2 and 3 again, and check if the result meets the requirements.
If still not, the manual maintenance is required. For details, please see the next chapter.
part. bottle until the solution is well mixed, then add 3 drops of the solution in to the 1.5mL centrifuge
tube. Cap the tube and shake it until this solution become well mixed, as shown in Figure 6-12.
Optical System
6-8
Figure 6-13 Optical screen of the stanadard
particle
6.4. Maintenance and Replacement of the Optical
System
When the optical system is determined as abnormal according to Section 6.3, and can
not be
restored by automatic maintenance, then manual maintenance will be necessary. Furthermore,
if the
optical system is determined as normal according to Section 6.3, but the scattergram or
categorization
of the blood sample is abnormal, then other problems except the optical system shall be
taken into
account.
Before performing maintenance and replacement on the optical system, prepare the
following
items: Tools: A crosshead screwdriver and an allen wrench
set.
Consumables: 4k-07 Std. part. (7μm), 1.5 mL centrifuge tube, microfiber clean
cloth,
dehydrated alcohol and probe
cleanser.
6.4.1 Maintenance of the Optical System
Before maintenance of the optical system, it is necessary to open the top cover of the
optical
system shield shell. As shown in Figure 14, use a crosshead screwdriver to remove the locking
screw.
Open the top cover carefully to reveal the internal structure of the optical system, as shown in
Figure
6-4.
Optical System
Tap "Status" > "Voltage&Current" in the menu to enter the Voltage&Current screen, the
laser will illuminate automatically.
Figure 6-14 Location of the screws on the shield
shell
Precautions before proceeding to the next step are as
follows:
➢ Never look directly into the laser with eyes or through an optical instrument;
➢ During test of optical system with the top cover open, please shelter the optical system
to prevent bright environmental light from irradiating the detector inside the optical
system.
Generally, the following steps can be followed to determine which part needs to be
maintained.
1. Check if the wires are firmly connected inside the optical system and if the optical path
is
blocked by wires.
2. Check if the output spot is normal. Place a small piece of white paper near the output
exit
and observe the light spot. The ideal spot shape is a vertical ellipse which is clipped at
both top and bottom, as shown in the left in Figure 6-15. The actual spot is shown in
the right in Figure 6-15 with a faint halo around it.
Optical System
Figure 6-15 Light spot at the output exit
Abnormal spots can be different, including dark spot, spot clustered into a dot, spot with
dark
lines, spot with a scattered halo, seriously damaged spot, spot with multiple dark dots in the
center, as
shown in Figure 6-16.
Figure 6-16 Example of abnormal output
spots
Abnormal light spots are usually caused by damage or contamination of the laser control
board,
the laser or the lens in the light source
assembly.
Missing parts, dark lines or dark dots in the spot are usually caused by contaminated lens
in the
light source assembly. A clean cloth dampened with dehydrated alcohol may be used to wipe
the lens
gently, spiraling outward from the center. Be careful not to touch the interior of the lens
barrel.
If the light spot disappears, darkens or diverges, then the laser control board may be
damaged.
After the problem is determined, replace the laser control board (be aware of electrostatic)
separately
and adjust the variable resistor on the board. Perform a std. part. test in accordance with 6.3 to
ensure
the std. part. indicators to meet the requirements. After replacement, a gain calibration in
accordance
with Section 4.6 as well as a calibration in accordance with Section 4.3 shall be performed
on the
optical system.
Optical System
If the light spot disappears, converges, darkens or diverges, and the laser control
board is
determined to be in good condition, then the laser could have been burned. Since the light
source
assembly can not be replaced separately, it will be necessary to replace the optical
system.
3. Observe the light spots on the surface and inside the flow cell from the following angles,
as shown in Figure 6-17. If the exterior of the flow cell is very bright, then the exterior may
be stained. Use a clean cloth dampened with dehydrated alcohol to wipe the exterior, until
the bright part darkens or disappears, as shown in the right in Figure 6-17. If the interior of
the flow cell is very bright and can not be darkened by the built-in cleaning procedure, then
it will be necessary to manually rinse the inside of the flow cell.
Figure 6-17 Flow cell before and after
cleansing
The cleansing procedure is as follows: Prepare a syringe with a 100 mm long
Teflon
tube, a 200 mm long Teflon tube and probe cleanser, as shown in Figure 6-18.
Shutdown
the analyzer, remove the tubes at the waste outlet and the sheath inlet of the flow
cell.
Connect the syringe to the waste outlet. Connect one end of the other Teflon tube
to the
sheath inlet, and put another end into the probe cleanser. Draw the probe cleanser
with the
syringe until the probe cleanser enters the syringe. At this time, the flow cell will be
filled
with the probe cleanser. After soaking for about 10 minutes, use clean water instead
of the
cleanser. Draw the syringe forcefully for 2 to 3 times, until the bright spots in the flow
cell
darken or disappear.
Connect the optical path and the tubes and verify the connection, and then turn
on the
analyzer power.
Optical System
Figure 6-19 Output spot and reflection spot
After the maintenance is completed, verify if the optical system is working correctly
in
accordance with the steps in Section
6.3:
➢ If the std. part. CV meets the requirement, but the CG position is too low or too
high,
slightly adjust the variable resistor on the laser control board as shown in Figure 6-11,
until the CG position meets the requirement. After maintenance according to this
procedure, a gain calibration in accordance with Section 4.6 as well as a calibration in
accordance with Section 4.3 shall be performed on the optical system.
➢ If the CG position meets the requirement but the CV doesn't, then the maintenance is
not
qualified. Perform another check and maintenance in accordance with this
section.
➢ If the CG position and the CV can not meet the requirements after the maintenance,
then it
will be necessary to replace the optical
system.
Figure 6-18 Preparation before cleaning the flow cell
interior
4. Check if the output light is perpendicular to the flow cell. Place an inner hexagon
spanner at the output exit. The output spot and the spot reflected by the flow cell shall
appear simultaneously and strictly coincide with each other, as shown in Figure 6-19.
Optical System
6.4.2 Replacement of the Optical System
If the problem is not solved after maintenance, or if the problem is not serviceable, then
it is
necessary to replace the optical system with a new one. The replacement procedure is as
follows:
1. Power off the analyzer.
2. First, gently disconnect the waste outlet tube from the optical system, and connect to
a
syringe. Disconnect other tubes, aspirate remaining fluid with the syringe from the
system. Unscrew the screws and disconnect the signal line from the optical system,
as shown in Figure 6-20.
Note: Follow the procedure and prevent the corrosive fluid from falling onto
the
frame!
Figure 6-20 Remove the optical
system
3. Remove the optical system carefully and short the tubes of the optical system in
accordance
with Figure 6-21.
Optical System
Figure 6-21 Short the tubes of the optical system
together
4. Install the new optical system into the analyzer. Connect the signal wires, fluidics
and
optical path. Turn on the analyzer and verify the status of the new system in
accordance with the steps in Section 6.3.
Note: The fluidic interfaces of the optical system are very fragile. Be careful to
avoid
knocking them when connecting the tubes during
installation!
5. Perform a gain calibration in accordance with Section 4.6 as well as a calibration
in
accordance with Section 4.3 on the optical
system.
Optical System
7 Fluidics
7.1. Measurement Flow
The fluidics of the analyzer can be divided into two measurement channels: ➢
WBC&HGB Channel ➢ RBC&PLT Channel The system flowchart of the
WB-CBC+DIFF mode is shown below (DIFF lyse and DIFF sample configuration &
measurement are not available in CBC mode):
Figure 7-1Fluidics flowchart (WB-CD mode)
7-1
The system flowchart of the PD-CBC+DIFF mode is shown below (DIFF lyse and DIFF
sample configuration & measurement are not available in CBC mode):
Figure 7-2Fluidics flowchart (PD-CD
mode)
7.1.1 WBC&HGB Channel
DIFF Measurement
∎ Reagents:
Fluidics