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Auto Hematology Analyzer

Model:KT-60/KT-62/KT-40/KT-42

Service Manual
For In Vitro Diagnostic Use
© 2004-2019 Genrui Biotech Inc. All rights reserved.

For this Service Manual, the issued date is 2019-11 (Version: A/1).

Item No.: P01.91.700065-01

Intellectual Property Rights


Genrui Biotech Inc. (hereinafter called Genrui) owns the copyright to this unpublished
manual and intends to maintain it as confidential. This publication is to be used solely for the
purposes of reference for Genrui equipment.

Genrui owns this manual and all intellectual property rights (including copyright) in this
manual. Nobody is allowed to use, disclose or let others obtain part or whole information of
this manual in any manner whatsoever without the written permission of Genrui. Nobody is
allowed to take the following actions to part or all contents of this manual, including (but not
limited to) shoot, reproduce, copy, or translate it into other languages without the written
permission of Genrui.

Genrui reserves the final explanation right to this manual.

Genrui reserves the right to modify the content of this manual without prior notice.

Genrui reserves the right to make technical alterations without prior notice.

Genrui reserves the right to change the product specifications without prior notice.

Statement
Regarding this manual, Genrui will not take any warranty responsibility, expressed or
implied, including (but not limited to) warranties of merchantability and fitness for any
particular purpose.

Genrui is responsible for safety, reliability and performance of this equipment only in the
conditions that:

 All installation operations, expansions, readjustment, modifications and repairs of this


product are conducted by Genrui authorized personnel.

 Related electrical appliances conform to National Standards.

 The product is used in accordance with the operation guide.

Genrui will not take the responsibility for the products’ safety, reliability and performance
based on the following situations:

 Components are disassembled/reassembled, stretched and readjusted.

 Products are not properly operated according to the Operation Manual.


Warranty Service
Free service scope:
Where the equipments conform to the provisions of Genrui Warranty Services Ordinance
range can enjoy the free service.
Services to be charged:
(1) Services not included in Genrui Warranty Services Ordinance range should be charged
by Genrui.
(2) Damages caused by the following reasons should be charged for the services, even in
warranty period:
 Man-made damage
 Network voltage exceeds the equipment’s specified range
 Irresistible natural disasters
Genrui will not be responsible for the direct, indirect or eventual damages and delays
resulting from the following conditions (including but not limited to):
 Use the instrument improperly
 Replace parts or accessories not approved by Genrui
 Repair the instrument by personnel not authorized by Genrui

Customer Service Department


Manufacturer: Genrui Biotech Inc.
Address: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen,
China
Website: www.genrui-bio.com
E-mail: service@genrui-bio.com
Tel: +86 755 26835560
Fax: +86 755 26678789
 This analyzer can only be operated by test professionals, doctors or laboratory
technicians who have been trained by Genrui or its distributors.

 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.

 This equipment must be operated by skilled/trained professional maintenance


personnel.

 Be sure to operate and service the analyzer strictly as instructed in this manual and the
operation manual.
Table of Contents

Table of Contents
Table of Contents ..................................................................................... i

1. Product Overview .......................................................................... 1


1.1. Product Name................................................................................................... 1
1.1.1. Physical Specifications ............................................................................. 2
1.1.1. Electrical Specifications ............................................................................ 2
1.1.2. Environment Requirements ...................................................................... 3
1.1.3. Product Specifications .............................................................................. 3
1.2. Testing Parameters .......................................................................................... 3
1.3. Product Description .......................................................................................... 6
1.3.1. Main unit .................................................................................................... 7
1.3.2. Indicator..................................................................................................... 7
1.3.3. Power switch ............................................................................................. 7
1.3.4. [Aspirate] key ............................................................................................ 7
1.3.5. Network/USB port ..................................................................................... 7
1.4. Product Configuration ....................................................................................... 8
1.5. Reagents, Controls and Calibrators ................................................................. 8
1.5.1. Reagents ................................................................................................... 8
1.5.2. Controls and Calibrators ........................................................................... 9
1.6. Information Storage Capacity ........................................................................... 9

2. Installation ................................................................................... 10
2.1. Checking before Installation ........................................................................... 10
2.2. Installation Requirements ............................................................................... 10
2.2.1. Space Requirements .............................................................................. 10
2.2.2. Power Requirements ...............................................................................11
2.2.3. Environmental Requirements ..................................................................11
2.2.4. Moving and Installation Method .............................................................. 12

3. Working Principles ...................................................................... 13


3.1. Overview ......................................................................................................... 13
3.2. Workflow ......................................................................................................... 13
3.3. Sample Aspiration........................................................................................... 14
3.4. WBC/RBC/PLT Measurement ........................................................................ 14
3.4.1. Electrical Impedance Method.................................................................. 14
3.4.2. Derivation of RBC-Related Parameters .................................................. 15
3.4.3. Derivation of PLT-Related Parameters ................................................... 15
3.5. HGB Measurement ......................................................................................... 16
3.5.1. Colorimetric Method ................................................................................ 16
3.5.2. HGB......................................................................................................... 16

4. Software and Interface ................................................................ 17


Service Manual i
Table of Contents

4.1. Login ................................................................................................................17


4.2. Calibration .......................................................................................................17
4.2.1. Calibration Factor and Transfer Factor....................................................17
4.2.2. Calibration ................................................................................................18
4.3. Sample Probe Debugging ...............................................................................20
4.4. Gain Setting.....................................................................................................21
4.5. Performance ....................................................................................................22
4.5.1. Background test .......................................................................................22
4.5.2. Carryover .................................................................................................23
4.6. Advanced Toolbox ...........................................................................................24
4.6.1. System Configuration ..............................................................................24
4.6.2. One-key Export ........................................................................................25
4.7. Software Upgrade ...........................................................................................26
4.8. Status Indicator ...............................................................................................27
4.9. Buzzer .............................................................................................................28

5. Data Transmission ....................................................................... 29


5.1. LIS Connection ................................................................................................29
5.2. Communication Error Analysis ........................................................................32
5.2.1. Physical Connection ................................................................................32
5.2.2. Communication Setup .............................................................................34
5.2.3. Network Firewall ......................................................................................35

6. Fluidic System ............................................................................. 36


6.1. Measurement Flow ..........................................................................................36
6.1.1. WBC&HGB Channel ................................................................................38
6.1.2. RBC/PLT Channel ...................................................................................39
6.2. Sample Volume ...............................................................................................39
6.3. Introduction to Fluidic Parts.............................................................................40
6.3.1. LVMK Fluidic Valve ..................................................................................40
6.3.2. Syringe Linkage .......................................................................................42
6.3.3. Negative Pressure Pump Syringe ...........................................................43
6.3.4. Sample Probe ..........................................................................................44
6.3.5. Sample Probe Wash Set .........................................................................45
6.3.6. Baths ........................................................................................................45
6.4. Detailed Introduction of Fluidic Structure ........................................................46
6.4.1. Sampling and dispensing channel ...........................................................46
6.4.2. WBC & HGB Channel ..............................................................................47
6.4.3. RBC/PLT Channel ...................................................................................48
6.4.4. Precautions for Assembly and Service ....................................................48
6.5. Introduction to Sequences ..............................................................................50
6.5.1. Measurement Sequence in Whole Blood Normal Mode .........................51
6.5.2. Measurement sequence in Predilute Normal mode ................................59
6.5.3. Measurement sequence in L-WBC/PLT mode ........................................59
6.5.4. Introduction to the Maintenance Sequences ...........................................60

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Table of Contents

7. Hardware System ........................................................................ 62


7.1. Overview ......................................................................................................... 62
7.1.1. Hardware Resources .............................................................................. 62
7.1.2. System Troubleshooting ......................................................................... 63
7.2. Main Control Board Module ........................................................................... 64
7.2.1. Main Input Signal .................................................................................... 64
7.2.2. Main Output Signal.................................................................................. 64
7.2.3. Function and Performance Realization .................................................. 65
7.2.4. Module Circuit Introduction ..................................................................... 65
7.2.5. Troubleshooting ...................................................................................... 69

8. Troubleshooting .......................................................................... 74

9. Mechanical System ..................................................................... 80


9.1. Overview ......................................................................................................... 80
9.1.1. Front View ............................................................................................... 80
9.1.2. Back View ............................................................................................... 81
9.1.3. Left View.................................................................................................. 82
9.1.4. Right View ............................................................................................... 82
9.2. Components ................................................................................................... 83
9.2.1. Introduction ............................................................................................. 83
9.2.2. Overall Unit ............................................................................................. 83
9.2.3. Front Panel Assembly ............................................................................. 86
9.2.4. Fluidic Plate Assembly ............................................................................ 87
9.2.5. Sampling assembly ................................................................................. 88
9.2.6. Horizontal Movement Assembly ............................................................. 89
9.2.7. Vertical Movement Assembly .................................................................. 90
9.2.8. Shield Cover of Counting Pool ................................................................ 92
9.2.9. Rear Plate Assembly .............................................................................. 93
9.2.10. Power assembly ...................................................................................... 94
9.2.11. Shell Assembly........................................................................................ 95
9.3. Removal and Installation ................................................................................ 97
9.3.1. Tools........................................................................................................ 97
9.3.2. Preparation for Disassembly ................................................................... 97
9.4. Disassembling the Main Unit .......................................................................... 98
9.4.1. Removing the Top Plate Assembly......................................................... 99
9.4.2. Removing the Left/Right Plate Assembly ............................................... 99
9.4.3. Removing the Power Plate Assembly................................................... 100
9.4.4. Removing the Rear Plate ...................................................................... 101
9.4.5. Removing the Front Shell Assembly..................................................... 102
9.4.6. Shield Cover of RBC and WBC Counting Pool Repair Assembly ........ 102
9.4.7. Removing the Aperture ......................................................................... 104
9.4.8. Replacing the Isolator ........................................................................... 105
9.4.9. Removing the Right Plate Solenoid Valve Assembly ........................... 106
9.4.10. Removing the Front Valve Assembly.................................................... 107
9.4.11. Removing the Pump ............................................................................. 108

Service Manual iii


Table of Contents

9.4.12. Removing the Waste Pump Assembly ..................................................109


9.4.13. Removing the Sample Probe Wash Set ................................................ 110
9.4.14. Replacing the Sample Probe ................................................................. 111
9.4.15. Removing the Sampling Assembly ........................................................ 112
9.4.16. Replacing the Thermal Recorder........................................................... 113
9.4.17. Removing the Indicator board PCBA..................................................... 114
9.4.18. Removing the Touch Screen Inverter(Only for KT-60/KT-62 models) .. 115
9.4.19. Removing the LCD Module.................................................................... 116
9.4.20. Removing the Touch Screen ................................................................. 117
9.4.21. Removing the Scan Head Adapter Board ............................................. 118

10. Debugging .................................................................................. 119


10.1. Sample Probe Position Adjustment............................................................... 119
10.1.1. Sample Probe to the Center of the WBC Bath ...................................... 119
10.1.2. Sample Probe to the Center of the RBC Bath .......................................120
10.1.3. Sample Probe Horizantal Aspiration Position ........................................121
10.2. HGB Blank Voltage Setup .............................................................................122
10.3. RBC Gain Setup ............................................................................................123
10.4. WBC Gain Setup ...........................................................................................124

11. Commissioning and Verification after Servicing .................... 125

12. Service BOM ............................................................................... 129

13. Appendix .................................................................................... 131


Appendix A Fluidic Diagram .....................................................................................131
Appendix B Connection and Tube............................................................................131
Appendix C Hardware Block Diagram......................................................................137
Appendix D Commissioning and Verification Form ..................................................138

iv Service Manual
Product Overview

1. Product Overview

1.1. Product Name


 Name: Auto Hematology Analyzer

 Model: KT-60/KT-62/KT-40/KT-42

 Appearance:

 KT-60(left), KT-62(right)

 KT-40(left), KT-42(right)

Service Manual 1
Product Overview

1.1.1.Physical Specifications

Table 1-1 Dimensions and weight

KT-60/KT-62/KT-40/KT-42 Whole device

Width ≤ 300mm
Dimensions Height ≤ 400mm (with foot)
Depth ≤ 430mm

Weight ≤ 20Kg

1.1.1. Electrical Specifications


Table 1-2 Main unit power supply

Parameter Value

Voltage 100-240V~

Input power 160VA

Frequency 50/60Hz

Fuse specification: F6.3A L250V

 Only fuses of the specified specification shall be used.

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Product Overview

1.1.2.Environment Requirements
Table 1-3 Overall environment requirements

Operating Storage Running


environment environment environment
requirements requirements requirements

Ambient
10℃~30℃ -10℃~40℃ 10℃~40℃
temperature

Relative
≤ 85% 10%~90% 10%~90%
humidity

Atmospheric
70kPa~106kPa 50kPa~106kPa 70kPa~106kPa
pressure

1.1.3.Product Specifications
 Measurement mode

Four measurement modes are provided: Normal, L-WBC , L-PLT and L-WBC/PLT.

 Sample mode

Three sample modes are provided: Whole Blood, Prediluted and Capillary Whole Blood.

Normal mode can be use in the three sample modes.

L-WBC and L-PLT modes can only be used in Whole Blood and Capillary Whole Blood.

 Throughput

The testing speed of KT-60/KT-62 for Whole Blood/Capillary WB/Prediluted blood modes in
open vial sampling mode is not lower than 40 samples per hour.

The testing speed of KT-40/KT-42 for Whole Blood/Capillary WB/Prediluted blood modes in
open vial sampling mode is not lower than 60 samples per hour.

1.2. Testing Parameters


In Normal, L-WBC/PLT (where L-PLT and L-WBC modes are only available in whole blood
mode and Capillary WB mode), the corresponding parameters are detailed in the following
table:

Table 1-4 Parameters

Parameter Norma L-WBC/PL


Name Abbreviation
Group l T

White Blood Cell


WBC group WBC
count √ √
(7)

Service Manual 3
Product Overview

Parameter Norma L-WBC/PL


Name Abbreviation
Group l T

Lymphocytes
Lym% √ √
percentage

Intermediate cell
Mid% √ √
percentage

Neutrophilic
granulocyte Gran% √ √
percentage

Lymphocytes count Lym# √ √

Intermediate cell
Mid# √ √
count

Neutrophilic
Gran# √ √
granulocyte count

RBC group (8) Red Blood Cell count RBC √ √

Hemoglobin
HGB √ √
Concentration

Mean Corpuscular
MCV √ √
Volume

Mean Corpuscular
MCH √ √
Hemoglobin

Mean Corpuscular
Hemoglobin MCHC √ √
Concentration

Red Blood Cell


Distribution Width - RDW-CV √ √
Coefficient of Variation

4 Service Manual
Product Overview

Parameter Norma L-WBC/PL


Name Abbreviation
Group l T

Red Blood Cell


Distribution Width - RDW-SD √ √
Standard Deviation

Hematocrit HCT √ √

Platelet count PLT √ √

Mean Platelet Volume MPV √ √

Platelet Distribution
PDW √ √
Width
PLT group (6)

Plateletcrit PCT √ √

Platelet larger cell count P-LCC √ √

Platelet larger cell ratio P-LCR √ √

Table 1-5 Histograms

Name Abbreviation

White Blood Cell Histogram WBC Histogram

Red Blood Cell Histogram RBC Histogram

Platelet Histogram PLT Histogram

 “√” means “available under the mode”, “/” means “not available under the mode”.

Service Manual 5
Product Overview

1.3. Product Description


 KT-60/KT-62/KT-40/KT-42 Auto Hematology Analyzer primarily comprises the host,
accessories and software. The host includes a display screen, sampling assembly,
fluidic system, power interface, reagent interface and signal interface. Model
differences are as follows:

Model KT-60 KT-62 KT-40 KT-42

60 60 40 40
Throughput
samples/hour samples/hour samples/hour samples/hour

Screen size 10.4 inch 10.4 inch 8 inch 8 inch

Memory 600000 500000 400000 300000

 The illustrations in this manual are based on KT-60. The structure of KT-62, KT-40 and
KT-42 are basically the same.

 This analyzer is heavy and may cause personal injury if handled by only one person. It
requires at least two people to transport the analyzer. It is important to follow
appropriate safety rules and use appropriate tools while handling.

Figure 1-1 Front view of the main unit

1. Touch screen 2. Sample probe 3. [Aspirate] key

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Product Overview

Figure 1-2 Back view of the main unit

1. Network port 2. USB port 3. Power input socket


4. Waste sensor socket 5. Diluent inlet 6. Waste outlet

1.3.1.Main unit
The machine for analysis and data processing, it is the main part of the product.

1.3.2.Indicator
The indicator is located in the lower right side of the analyzer (front side). It indicates the
status of the analyzer including ready, running, error, standby and on/off, etc.

1.3.3.Power switch
The power switch is located on the rear side of the analyzer. It is used to turn on/off the
analyzer.

 Do not turn on/off the switch repeatedly in a short time to avoid damaging the analyzer.

1.3.4.[Aspirate] key
The [Aspirate] key is located in the middle of the right front side. Press the key to start the
selected analysis, dispense diluent or exit from standby mode.

1.3.5.Network/USB port
There are 4 USB ports, 1 network port on the left side of the main unit for peripheral

Service Manual 7
Product Overview

connection or data transmission.

1.4. Product Configuration


The system configuration is composed mainly of the main analyzer unit, accompanying
accessories and reagent system. The user can choose an optional external scanner.

The USB port can be used to connect the following printer models: HP Color LaserJet Pro
M252n, HP LaserJet Pro P1108 and HP LaserJet Pro P1102.

1.5. 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 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. Otherwise, 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.

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

1.5.1.Reagents
1) Diluent

It is used to dilute the blood samples to achieve functions such as blood cell counting,
volume measurement and hemoglobin measurement.

2) LH lyse

It is used to lyse red blood cells, count and differentiate WBCs, and determine the HGB.

3) Probe cleanser

It is used to clean the analyzer regularly.

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Product Overview

1.5.2.Controls and Calibrators


The controls and calibrators are used for calibration and quality control of the analyzer.

The controls are industrial whole blood products, used for monitoring and evaluating the
accuracy of the hematology analyzer. They are available in low, normal, and high levels. The
calibrators are also commercially prepared whole blood products, used for calibration of the
analyzer to establish metrological traceability for measurement results. Store and use the
controls and calibrators as instructed by their instructions for use.

1.6. Information Storage Capacity


Table 1-7 Data storage requirements

KT-60’s storage capacity of sample data is not less than 600000


Storage KT-62’s storage capacity of sample data is not less than 500000
capacity KT-40’s storage capacity of sample data is not less than 400000
KT-42’s storage capacity of sample data is not less than 300000

The storage contents shall include at least the following information:


Storage
counting results and diagrams (including histograms), sample information,
contents
patient information, alarm information, special information of the instrument

Service Manual 9
Installation

2. Installation

2.1. Checking before Installation


All the analyzers have been inspected strictly before packing and shipping. When you
received your analyzer, before opening the packaging, perform a thorough inspection and
note whether there is any of the following damage:

1) Up-side-down or distortion of the packaging.

2) Obvious water marks on the packaging.

3) Obvious signs of being striked on the packaging.

4) Packaging shows signs of having been opened previously.

If you notice any of the above instances of damage, please immediately notify your local
distributor.

If the outer packaging is intact, unpack it in the presence of your local distributor and
conduct the following inspection:

1) Verify if all the components are equipped according to the packing list.

2) Carefully check the appearance of all the components to verify whether there is
breakage, crash or deformity.

If you notice any shipping damage or missing part, please immediately notify your local
distributor.

2.2. Installation Requirements


2.2.1.Space Requirements
Check the site for proper space allocation. In addition to the space required for the analyzer
itself, arrange for:
1) proper height to place the analyzer;
2) at least 50cm between the left and right side door of the analyzer and the walls,
which is the preferred access to perform service procedures;
3) at least 50cm behind the analyzer for cabling and ventilation.

10 Service Manual
Installation

 There should be enough room on and below the countertop to accommodate the
reagents and waste containers.
 The diluent container shall be put within 1.0m under the analyzer, lyse containers are
placed inside the analyzer.
 The countertop (or the floor) where the analyzer is placed shall be able to withstand at
least 40kg of weight.

2.2.2.Power Requirements
Table 2-1 Power specification

Voltage Input power Frequency

Analyzer 100-240V~ 160VA 50/60Hz

 Make sure the analyzer is properly grounded.


 Before turning on the analyzer, make sure the input voltage meets the requirements.

 Using pinboard may bring the electrical interference and the analysis results may be
unreliable. Please place the analyzer near the electrical outlet to avoid using the
pinboard.
 Please use the original power cable shipped with the analyzer. Using other power cable
may damage the analyzer or cause unreliable analysis results.

2.2.3.Environmental Requirements
1) Operating temperature range: 10℃-30℃
2) Relative humidity: ≤ 85%
3) Atmospheric pressure: 70.0kPa-106.0kPa

Service Manual 11
Installation

 The environment shall be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
 It is advisable to evaluate the electromagnetic environment prior to operation of this
analyzer.
 Keep the analyzer away from strong sources of electromagnetic interference, as these
may interfere with the proper operation.
 Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
 Do not place the analyzer in direct sunlight or in front of a source of heat or wind.
 The environment shall be ventilated.
 Place the analyzer on a horizontal flat surface.
 Connect only to a properly earth grounded outlet.
 Only use this analyzer indoors.

2.2.4.Moving and Installation Method


Moving and installation of the analyzer shall be conducted by authorized personnel. Do not
move or install your analyzer without the presence of authorized personnel or your local
distributor.

 Installation by personnel not authorized or trained by Genrui may cause personal injury
or damage your analyzer. Do not install your analyzer without the presence of
Genrui-authorized personnel or local distributor.

 Before the analyzer is shipped out, the sample probe is fixed by a plastic cable tie to
avoid damaging the sample probe during transportation. Remove the cable tie before
using the analyzer.

12 Service Manual
Working Principles

3. Working Principles

3.1. Overview
This analyzer uses Coulter priciple to test the number of WBC, RBC and PLT; colorimetric
method to determe HGB concentration. 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 is 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
complete the core task of the whole system, i.e. sample measurement and analysis.

Service Manual 13
Working Principles

3.3. Sample Aspiration


If you are to analyze a whole blood sample in the open vial sampling mode, the analyzer will
aspirate 9μL (Normal mode, L-PLT and L-WBC ) of the sample.

If you are to analyze a capillary blood sample in the open vial sampling mode, you should
first manually dilute the sample (20μL of capillary sample needs to be diluted by 1000μL of
diluent, dilution ratio: 1:51) and then present the pre-diluted sample to the analyzer, which
will aspirate 320μL of the sample.

3.4. WBC/RBC/PLT Measurement

3.4.1. Electrical Impedance Method


WBCs/RBCs/PLTs are counted and sized by the electrical impedance method. The blood
sample enters the WBC detection unit, and the RBC/PLT detection sample enters the RBC
detection unit after being diluted twice. The detection unit has a small opening called a
detection aperture. There are a pair of positive and negative electrodes on both sides of the
small hole to connect the constant current power supply.This method is based on the
measurement of changes in electrical resistance produced by a particle, which in this case
is a blood cell, suspended in a conductive diluent as it passes through an aperture of known
dimensions. A pair of electrodes is submerged in the liquid on both sides of the aperture to
create an electrical pathway. As each particle passes through the aperture, a transitory
change in the resistance between the electrodes is produced. This change produces a
measurable electrical pulse. The number of pulses generated represents the number of
particles that passed through the aperture. The amplitude of each pulse is proportional to
the volume of each particle.

Figure 4-2 Electrical Impedance Method

14 Service Manual
Working Principles

Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of certain amplitude. The analyzer presents the cell histogram, whose
x-coordinate represents the cell volume (fL) and y-coordinate represents the number of the
cells.

3.4.2.Derivation of RBC-Related Parameters


1) RBC

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

2) MCV

Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
expresses the result in fL.

3) HCT, MCH and MCHC

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.

RBC×MCV
HCT =
10

HGB
MCH =
RBC

HGB
MCHC = × 100
HCT

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

4) RDW-CV

Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation) of
the erythrocyte distribution width, which is expressed in %.

5) RDW-SD

RDW-SD (RBC Distribution Width – Standard Deviation, fL) is obtained by calculating the
standard deviation of erythrocyte size distribution.

3.4.3.Derivation of PLT-Related Parameters


1) PLT

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

2) MPV

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

3) PDW

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

Service Manual 15
Working Principles

reported as 10(GSD).

4) PCT

This analyzer calculates the PCT as follows and expresses it in %, where the PLT is
expressed in 109/L and the MPV in fL.

PLT×MPV
PCT =
10000

3.5. HGB Measurement

3.5.1.Colorimetric Method
The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a certain
amount of lyse, which converts hemoglobin to a hemoglobin complex that is measurable at
530nm. An LED is mounted on one side of the bath and emits a beam of monochromatic
light, whose central wavelength is 530nm. The light passes through the sample and is then
measured by an optical sensor that is mounted on the opposite side. The signal is then
amplified and the voltage is measured and compared to the blank reference reading
(readings taken when there is only diluent in the bath), and the HGB is measured and
calculated in the analyzer automatically.

3.5.2.HGB
The HGB is calculated per the following equation and expressed in g/L.

HGB (g/L) = Constant x Log10 (Blank Photocurrent/Sample Photocurrent)

16 Service Manual
Software and Interface

4. Software and Interface

4.1. Login
Log in using the service level username and password:

Username: Service

Password: GRKT06

 The login password is case sensitive.

4.2. Calibration
4.2.1.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 value. The calculation equation of the calibration factor
is:

The target result


Calibration factor =
The analysis result

There are two different analysis modes: Normal and Smart counting Mode. The two analysis
modes correspond to two fluidic sequences respectively. 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 transfer factor. The calculation equation of the transfer factor is:

𝑀𝑒𝑎𝑛1(Normal mode)
Transfer = × 100%
𝑀𝑒𝑎𝑛2(Smart counting mode)

Whole blood is the same as the capillary WB, and the smart counting mode of the capillary
WB call the transfer coefficient of whole blood;

Predilute has no smart counting mode, so there is no need to use transfer coefficients;

Service Manual 17
Software and Interface

There are two calibration factors: factory calibration factor and user calibration factor.
For the Whole Blood/ Capillary WB/Predilute mode, the analysis result will be calculated by
the following equation:
𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐫𝐞𝐬𝐮𝐥𝐭 = 𝐌𝐞𝐚𝐬𝐮𝐫𝐞𝐦𝐞𝐧𝐭 𝐯𝐚𝐥𝐮𝐞 × 𝐅𝐚𝐜𝐭𝐨𝐫𝐲 𝐜𝐚𝐥𝐢𝐛𝐫𝐚𝐭𝐢𝐨𝐧 𝐟𝐚𝐜𝐭𝐨𝐫 × 𝐔𝐬𝐞𝐫 𝐜𝐚𝐥𝐢𝐛𝐫𝐚𝐭𝐢𝐨𝐧 𝐟𝐚𝐜𝐭𝐨𝐫

For the Smart counting 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 generate calibration factors and transfer factors of five traceable
parameters: WBC, RBC, HGB, MCV and PLT.

 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%.

4.2.2.Calibration

Figure 4-1 Service level calibration-whole blood screen

18 Service Manual
Software and Interface

Figure 4-2 Service level calibration- Predilute screen

The service level calibration with calibrators in whole blood mode will generate the factory
calibration factor and transfer factor at a time. The first 6 counts are performed in Normal
mode, and the last 6 counts are performed in Smarting counting 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.

The service level calibration with calibrators in Predilute mode will generate the factory
calibration factor and transfer factor at a time. After all the 5 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 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].

 Please use specified calibrators for calibration before their expiration date.

Service Manual 19
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.

4.3. Sample Probe Debugging


The purpose of sample probe debugging is to check if the probe can move to each working
position properly.

Figure 4-3 Sample probe debugging screen

Enter the sample probe debugging screen and click the “Initial Position” button. Wait until
theinitialization is completed before starting the sample probe debugging. For detailed
information, please refer to Section 10.1 “Sample Probe Position Adjustment” in Chapter 10.

20 Service Manual
Software and Interface

4.4. Gain Setting


The WBCgain, RBC gain and HGB gain can be set up in the Gain Setting screen.

Figure 4-4 Gain setting screen

The WBC gain, RBC gain and HGB gain are hardware gains, which require the digital
potentiometer to be set. The range of gain setting is [0, 255].

The RBC gain setting can be calculated by the following equation:

New MCV New gain value + 28.16


=
Old MCV Old gain value + 28.16

The HGB gain setting does not need to be calculated by an equation, just modify the
setting until the background voltage is equal to 4.5±0.1V.

Service Manual 21
Software and Interface

 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.

4.5. Performance
4.5.1.Background test

Figure 4-5 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, then the background test is passed.

22 Service Manual
Software and Interface

4.5.2.Carryover

Figure 4-6 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:

First low level sample result − Third low level sample result
Carryover (%) = × 100%
Third high level sample result − Third low level sample result

Service Manual 23
Software and Interface

4.6. Advanced Toolbox


4.6.1.System Configuration

Figure 4-8 System configuration screen

On the System Configuration tab of the Advanced Toolbox, you can modify the language
type and make software upgrades.

 The modification to language type will not take effect until after the analyzer is restarted.

 At most 500 inf files can be saved. After 500 files are saved, the new files will overwrite
the old files. (Automatic setting)

24 Service Manual
Software and Interface

4.6.2.One-key Export

Figure 4-9 One-key export screen

The contents that can be exported by One-Key operation include:

 Inf files
 Special information files
 Instrument information: includes version information, configuration parameter (gain
and calibration), algorithm parameters, instrument status, software language and
instrument name
 Software debug information: includes parameter setting, error log, upgrade log and
system log
 Closed reagent information: includes closed reagent information and counter
information

 The USB flash drive has been preformatted as FAT32.

 There is enough free space in the USB flash drive. It is recommended to reserve 4G
space.

Service Manual 25
Software and Interface

4.7. Software Upgrade


 Creat an upgrade USB flash drive

Copy the file named “ktUpdate.dav” to a formatted USB flash drive.

 The USB flash drive has been preformatted as FAT32.

 “ktUpdate.dav” is stored directly under the root directory of the USB flash drive.

 Upgrade

Insert the USB flash drive into the USB port on the analyzer. Enter the Advanced Toolbox
and launch Upgrade to upgrade the software according to the prompts. After the upgrade is
complete, you will be prompted to shut down and restart the analyzer.

 Never disconnect the USB flash drive or the power supply during the upgrade process.
Otherwise the analyzer may not be able to start.

 The duration of the upgrade process varies with the upgrade contents. Typically it will
last for around 10 minutes.

 Troubleshooting

If the upgrade fails, try again.

26 Service Manual
Software and Interface

4.8. 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 Remark

Ready Green light on Sequence is allowed

Green light
Running Sequence is being performed
flashing

Red light
Running with error The analyzer is running with error
flashing

An error has occurred and the analyzer is not


Stop with fault Red light on
running

No error, but fluidic Initialization (not involving sequence actions)


Yellow light on
actions are not allowed in startup process, standby status

Yellow light
Enter/Exit standby status Enter/Exit standby status
flashing

Service Manual 27
Software and Interface

4.9. 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
errors are cleared. It prompts to instruct the user with possible actions by the beep.

Table 4-2 Main unit buzzer prompts

When… How… Remark

Startup completed means


the whole startup process
Startup completed 1 short beep has been completed and
the analyzer is ready for
operation

2 short
Open-vial aspiration completed /
beeps

Press the aspirate key on the analysis


screens (including sample analysis, QC, When dialog box message
calibration, reproducibility, carryover, 1 long beep is given, the buzzer may
background, aging, optical gain calibration not beep.
count, etc.) when analysis cannot be started.

Long
Tap the touch screen to
Error intermittent
turn off the buzzer.
beeps

The analyzer enters ready


The analyzer enters ready status 1 short beep
status from other status.

If an error occurs during the


When the analyzer screen turns black and the
Turn off the shutdown process, turn off
message “Please power off the analyzer”
buzzer the buzzer when the
appears
screen turns black.

28 Service Manual
Data Transmission

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.

 Network Device

 Protocol setup

 Transmission mode

Figure 5-1 Communication setup screen

 Network Device

Click the pull-down lists to select wired and wireless device.

Wired:Wired refers to the setting of the universal connection network cable. When wired,
you can set the IP address, subnet mask, and so on.

Wireless:Wireless refers to the setting when connecting a wireless network card. When
wireless is selected, wireless WIFI can be set.

Service Manual 29
Data Transmission

 Protocol setup

IP address: IP address setting of the analyzer.

Subnet mask: The subnet mask of the analyzer, usually 255.255.255.0.

Default gateway: IP address of the gateway.

Mac address: Mac address of the analyzer, given by the factory, can not be changed.

LIS IP address: IP address used in the PC where the LIS software is located.

LIS port: Port number occupied by the LIS software.

Comm. protocol: For selecting the protocol type. Click the pull-down list and select the
appropriate communication protocol type from the options. Currently only HL7 protocol is
supported.

ACK synchronous transmission: This function can be activated by selecting the “ACK
Synchronous Transmission” checkbox. When this function is active, the ACK timeout is
defaulted as “10” seconds.

 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
 Auto communication
 Auto fetch info from LIS
 Transmit as print bitmap data

 “Auto retransmit” means that the communication can be resumed automatically after
the network resumes. (To check the “Auto retransmit”, the “ACK Synchronous
Transmission” must be checked first.)
 “Auto communication” means that it is automatically uploaded to the LIS after the
sample analysis is complete.
 “Auto fetch info from LIS” is a two-way LIS function. If this option is selected, press the

30 Service Manual
Data Transmission

[Get LIS] button in the next sample information interface in the “Sample Analysis”
interface, you can read the patient information from the LIS side.
 “Transmit as print bitmap data” means that the transmission mode of graphics data is
print bitmap data.

 Transmission method for histograms and scattergrams

Click the pull-down list and select the transmission method for histograms as required from
the following options:

 Not transmitted
 Bitmap
 Data

 “Not transmitted” means that it will upload neither the picture nor the data to the LIS.
 “Bitmap” means that it will upload histograms and scattergrams to LIS in BMP format.
 “Data” means that the histograms will be converted into binary data by the system and
uploaded to LIS in data format.

Service Manual 31
Data Transmission

5.2. Communication Error Analysis


5.2.1.Physical Connection
Check if the network cable works properly and the physical network connections are correct.

1) Communication is completed. The analyzer communicates with the LIS normally.

32 Service Manual
Data Transmission

2) Please ensure that the network is connected. Cause of communication error: direct
connection to the LIS terminal or connection to the LIS cable is not smooth.

Service Manual 33
Data Transmission

5.2.2.Communication Setup
Check if the network setup is correct, including the communication setup of the analyzer and
LIS.

1) Usually LIS communication setting is not provided. It should be consistent with the IP
address of the computer.

2) The communication address of the analyzer and the LIS communication address must
be on the same network segment. You need to set the IP address and port that are not
occupied independently. The LIS IP address should be consistent with the IP address of
the LIS.

3) If the communication is not set correctly, the analyzer can not communicate properly.

34 Service Manual
Data Transmission

4) Receiving response timed out. The analyzer turns on the ACK response mode and
communicates with the LIS terminal. The analyzer can not receive the response signal
from the LIS terminal.

5) Receiving response error. The analyzer turns on the ACK response mode,
communicates with the LIS terminal, the response data received by the analyzer does
not conform to the protocol and does not contain MSA | AA |.

6) Sending data timed out. The analyzer communicates normally with the LIS terminal,
sending data will be timed out when the network suddenly broken during the data
transmission.

5.2.3.Network Firewall
Open the network connection license of LIS and data management software, and that of the
analyzer’s port to check for the firewall.

Service Manual 35
Fluidic System

6. Fluidic System

6.1. Measurement Flow


The fluidic system of the analyzer can be divided into two measurement channels:

 WBC&HGB channel

 RBC&PLT channel

The system flowchart of the whole blood mode is shown below:

Venous
blood/Capillary
blood sample
9uL

WBC bath Diluent 1850uL

Aspirate 35uL of
Dilution ratio sample
1:251

LH lyse Diluent
WBC bath RBC bath
310uL 2200uL

WBC sample
RBC sample dilution
dilution ratio
ratio 1:18645.7
1:286

WBC bath RBC bath

WBC/HGB count RBC/PLT count

Figure 7-1 Fluidic system flowchart (Normal mode of whole blood)

36 Service Manual
Fluidic System

The system flowchart of the predilute mode is shown below:

Capillary blood sample 20μL

Diluent 1000μL

Sample 1020μL
dilution ratio 1:51

Outside the machine

Inside the machine


Aspirate 303uL
of sample

WBC bath Diluent 2100uL

Aspirate 30uL of
Dilution ratio sample
1:488.6

LH lyse Diluent
WBC bath RBC bath
310uL 220uL

WBC sample RBC sample


dilution ratio ration ratio
1:541.3 1:42347.4

WBC bath RBC bath

WBC/HGB count RBC/PLT count

Figure 7-2 Fluidic system flowchart (Normal mode of predilute)

Service Manual 37
Fluidic System

6.1.1.WBC&HGB Channel
 WBC counting and Classification detection
1) Reagents:

LH lyse: used for lysing red blood cells and platelets, and specific processing different
types of white blood cells

Diluent: background solution and cleaning

2) Measurement principle: electrical impedance method

3) Measurement parameters: WBC、LYM#、LYM%、MID#、MID%、GRAN#、GRAN%

4) Graphics: WBC histogram

5) Dilution ratio: 1:128

6) Counting duration: 10.0s

7) Counting pressure: -30kpa

8) Counting volume: The measurement volume is controlled by controlling the vacuum


and counting duration. Keep a stable vacuum to ensure a stable flow out of the aperture.
The measurement volume can be calculated by controlling the counting duration

9) Function description: In the WBC bath, 9ul blood sample was mixed with 1850ul
diluent. After the sample was aspirated twice, 0.310ml LH lyse was added. After a
certain period of reaction, the sample was inhaled into the bath through the aperture by
the negative pressure generated by the negative pressure pump. The cells are detected
by generating electrical signals during the passage of the aperture.

 HGB counting
1) Reagents:

LH lyse: used for lysing red blood cells and combining hemoglobin

Diluent: used for diluting and cleaning

2) Measurement principle: colorimetric method

3) Measurement parameters: HGB

4) Dilution ratio: 1:286

5) Function description: The measurement principle of HGB channel is the colorimetric


method, which obtains HGB concentration by comparing the transmitted light intensity
between background and blood.

38 Service Manual
Fluidic System

6.1.2.RBC/PLT Channel
1) Reagents:

Diluent: used for diluting, cleaning, providing conductive environment and equal volume
processing of cells

2) Measurement principle: impedance method

3) Measurement parameters: RBC, PLT

4) Graphics: RBC histogram and PLT histogram

5) Dilution ratio: 1:18645.7

6) Counting duration:10s

7) Counting pressure: -30kPa

8) Measurement volume: The measurement volume is controlled by controlling the


vacuum and counting duration. Keep a stable vacuum to ensure a stable flow out of the
aperture. The measurement volume can be calculated by controlling the counting
duration

9) Function description: Aspirate 35μL of sample (dilution ratio 1:251) with the sample
probe from the WBC bath. Move the probe to the RBC bath and mix this sample with
2.2mL of diluent to prepare a sample with dilution ratio of 1:18645.7. After mixing,
aspirate the sample with negative pressure in the vacuum chamber through the
aperture into the secondary bath. The cells will be measured while passing through the
aperture.

 Dilution ratio refers to the dilution ratio in the whole blood mode.

6.2. Sample Volume


Table 7-1 Sample volume

Whole
Capillary
Item blood Prediluted mode
blood mode
mode

Dilution outside the analyzer: 20μL of blood


Normal 9μL 9μL
sample; 1000μL of diluents, 303μL aspirated

L-WBC/PLT 9μL 9μL

Service Manual 39
Fluidic System

6.3. Introduction to Fluidic Parts


A brief introduction to the fluidic parts and their respective functions is provided in this
section. The symbols mentioned below refer to the symbols in the fluidics diagram.

6.3.1.LVMK Fluidic Valve


 Symbol

2-way valve

3-way valve

40 Service Manual
Fluidic System

 Appearance

2-way valve

3-way valve

 Function

2-way valve: to build up or cut off a passage. When power off, the passage from the inlet of
the valve to outlet is cut off; when power on, the passage is built up.

3-way valve: to switch among passages. When power off, the public end and the NO
(normally open) end are connected; when power on, the public end and the NC (normally
close) end are connected.

 The operating voltage of LVMK fluidic valves is 12V, and maximal bearable pressure is
300kPa. The internal movement of the valves is driven by electromagnet and the
restoration is driven by the spring, so it is recommended not put the valves power-on for
too long.

Service Manual 41
Fluidic System

6.3.2.Syringe Linkage
 Symbol

(8050uL)
(1130uL)

(50uL)
SR

 Appearance

 Function

Composed of a large volume syringe and a small volume syringe, the syringe linkage is
driven by a motor and a linkage. The parameter and the function of the syringe linkage are
shown in the table below:

Table 7-4 Parameter and function list of the syringe linkage

Name Specification Function

Small
Used for quantitative aspiration, distribution and secondary
volume Full scale 50ul
aspiration of blood samples
syringe

Middle
Full scale
volume Used for quantitative aspiration, distribution of LH lyse
1.13ml
syringe

Large Full scale Used for quantitative addition of diluent to WBC and RBC

42 Service Manual
Fluidic System

Name Specification Function

volume 8.05ml bath, the supply of the wash set and the cleaning of the inner
syringe and outer walls and the counting bath

6.3.3.Negative Pressure Pump Syringe


 Symbol

 Appearance (45mL)

 Function

Responsible for the emptying of sample probe wash set, WBC bath and RBC bath, and the
establishment of negative pressure during measurement.

Service Manual 43
Fluidic System

6.3.4.Sample Probe
 Symbol

 Appearance

Open-vial sample probe

 Function

Used for providing a rigid cavity with resistance to blood sample corrosion, which can collect
and dispense the blood as well as aspirate and dispense probe cleanser.

 The sample probe is flat-tipped with a side opening to ensure normal aspiration in case
that the tip touches the bottom of the sample tube.

44 Service Manual
Fluidic System

6.3.5.Sample Probe Wash Set


 Symbol

 Appearance

 Function

Provide a cavity for cleaning open-vial probe or piercing probe by liquid flow and collecting
waste fluids on the interior or exterior.

6.3.6.Baths
 WBC bath

Used for providing a place for WBC sample reactions and supplying well reacted WBC
samples, and for WBC/HGB measurement.

 RBC bath

Composed of primary bath, secondary bath and aperture. Used for providing a place for
RBC sample reactions and for RBC/PLT measurement.

 WBC isolation chamber

Provide a gas chamber to block interference signals from outside.

 RBC isolation chamber

Provide a gas chamber to block interference signals from outside.

Service Manual 45
Fluidic System

6.4. Detailed Introduction of Fluidic Structure


Please refer to Appendix A for the fluidic structure diagram

6.4.1.Sampling and dispensing channel


The structure of sampling and dispensing channel is shown below:
RT2
C19 C7 C8 C9
C10
T8 T9 T10

T17
T11

C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 2 3 1
T22-C14-T23
2 1 3 2
SV02 SV04
T19-C12-T18

T25-C15-T24

T16

T7 T20-C13-T21

T15
SPB
WBC RBC
Sample
probe T29 T32
C18
wash set T31
(8050uL)
(1130uL)

(50uL)

T30 T33
C17
T34
T37
T36
T35

Isolation Isolation
SR room 1 room 2

(45mL)
T52

1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29
T56

Waste
container

Main function:

1) Aspirate and dispense samples

Aspirate 9μL of blood sample by conjunctive use of small volume syringe of the syringe
linkage (SR) and the sample probe (SPB), and dispense the blood sample.

2) Clean the interior and exterior of the sample probe

The interior is cleaned by the collaboration of the large volume syringe of the syringe
linkage (SR) and SV02 and SV03 valves. The exterior is cleaned by the diluent which is
forced by the large volume syringe through SV02, SV03 and SV04 into the sample
probe wash set, with waste fluid recovered by the sample probe wash set, SV11 and
negative pressure pump.

3) Aspirate and dispense probe cleanser

During the aspiration, SV02 and SV03 are energized. 2mL of probe cleanser will be
aspirated by the SR from the SPB and stored mainly in the cleanser tanks (T21 and
T222). During the dispensation, the SPB is transported by the sampling assembly to the
RBC bath and WBC bath, SV02 and SV03 are kept energized. A certain volume of
probe cleanser in the SPB will be dispensed by the SR to the reaction baths.

46 Service Manual
Fluidic System

6.4.2.WBC & HGB Channel


Part of the fluidic structure is shown as follows:

The blue lines are diluent flows; yellow lines are LH lyse flows; orange lines are sample
flows; purple lines are waste fluid flows. Similarly hereinafter.
J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T9 T10

T17
T11 C4

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1

2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24
T16

T7 T20-C13-T21
T1

T15
SPB
WBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2

Shield T38
cover T48
SV09
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29
T56

Waste
container

Classification detection & WBC counting


1) The diluent as the background solution enters the WBC bath through the 8.05mL large
volume syringe SV02, SV03, SV04, SV05;

2) The blood sample is dispensed by the sample probe to the WBC bath, the LH lyse is
added by a 1130 ul LH lyse syringe through SV01;

3) The 45ml syringe is sucked into the air by opening the SV07, and the gas is pushed into
the isolation chamber 1 through T51, SV10, T45, C22, T45, T38, and the sample liquid
in the WBC bath are mixed and reacted by the generated bubbles;

4) The sample is aspirated by the negative pressure in the negative pressure pump into
the secondary bath (orange lines in the illustration). The cells will be measured while
passing through the aperture. The sample volume is calculated from the count duration.

5) After the measurement, the RBC bath is drained by the negative pressure pump and
the SV10.The cleaning of the secondary bath is described in RBC section.

HGB counting
The measurement principle of HGB channel is the colorimetric method, which obtains HGB
concentration by comparing the transmitted light intensity between background and blood.
The transmitted light intensity of the pure diluent in the WBC bath is measured at the
beginning of the count. The transmitted light intensity of the diluent with blood is measured
after the LH lyse reaction is completed (before preparation of the WBC sample counting).
The HGB value can be calculated by comparing the above two values.

Service Manual 47
Fluidic System

6.4.3.RBC/PLT Channel
Part of the fluidic structure is shown as follows:
RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11
SV06
2

C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 2 3 1
T22-C14-T23
2 1 3 2
SV02 SV04

T19-C12-T18

T28-C16-T27
T16

T7 T20-C13-T21

T15
SPB
RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
T37 2
T35
1

Isolation
SR room 2 SV08
1
T39 T40-C20-T41

T48
SV09 T49
1

(45mL)
T42-C21-T43

T50

T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29
T56

Waste
container

1) The diluent is added by the SR along the blue line (T7, SV02, T14, SV03, T16, SV04,
T17, SV05, T22, C14 and T2) to the RBC bath.

2) The sample probe distributes the diluted blood sample to the RBC bath, The 45ml
syringe is sucked into the air by opening the SV07, and the gas is pushed into the
isolation chamber 2 through T49, SV08, T41, C20, T40, T39, and the sample liquid in
the RBC bath are mixed and reacted by the generated bubbles;

3) The sample is aspirated by the negative pressure in the vacuum chamber into the
secondary bath (orange lines in the illustration). The cells will be measured while
passing through the aperture. The sample volume is calculated from the count duration.

4) The sample is aspirated by the negative pressure in the negative pressure pump into
the secondary bath (orange lines in the illustration). The cells will be measured while
passing through the aperture. The sample volume is calculated from the count duration.

5) After the measurement, the RBC bath is drained by the negative pressure pump and
the SV08.The cleaning of the secondary bath is that the negative pressure pump
syringe draws the diluent from SV06, T27, T28, T34, T29, T30, into the back pool, then
enters the negative pressure pump through T42, T43, SV09, T50, and is discharged by
the negative pressure pump.

6.4.4.Precautions for Assembly and Service


Precautions for installation of sampling assembly

No. Precautions

Strap the tube above the sample probe at the positioning hole to prevent the tube
1
connector from being stressed by the vertical motion of the sample probe.

2 Move the sampling assembly horizontally and vertically to ensure that the sample

48 Service Manual
Fluidic System

No. Precautions
tube is unobstructed with no folding and interference with the preamplifier, fluidics
separator, right door, motor, valves and tube straps.

3 Ensure that the sample tube is not squeezed or deformed at the tube straps.

Ensure that there is no folding or interference when the sample probe wash set fluid
4
tube is moving horizontally or vertically in the sampling assembly.

Precautions for installation of reaction bath assembly

No. Precations

The waste tube for the reaction bath needs to be wrapped in the vertical direction to
1
a height above the liquid level with 3mL of liquid in the bath.

2 Install the aperture so that the surface with the tapered bore faces the primary bath.

Precautions for servicing the whole fluidics

No. Precautions

1 The tubes shall be unobstructed with no twisting, squeezing, creases and folds.

Never bend any of the tubes. Pay special attention to the Teflon tubes. If any Teflon
2
tube is folded, be sure to replace it with a new tube.

3 The bending diameter of all the tubes should be greater than 30mm.

When cutting the tubes, the cutting face shall be perpendicular to the axis of the
4
tube.

When connecting the transit tube with the Teflon tube, make sure the insertion depth
5 is 10-13mm. Keep no clearance between the two connected rigid tubes as far as
possible. Keep the end of the Teflon tubes smooth and unwrinkled.

6 Thick Teflon tubes connect with thick 50 tubes, the insertion depth is at least 10mm.

If not specifically stated, when connecting hoses, transit tubes with connectors, valve
7 ports or dosing tubes on the reaction bath, the end of the hose or transit tube shall be
fully inserted.

8 It is not necessary to over tighten the straps for fastening the tubes.

Strap all the tubes that need winding, ensuring that the tube is not deformed and
9
folded.

10 For T- transit tubes tubes, the side ports and the middle port shall be treated
differently. Please assemble them strictly in accordance with the requirements of the

Service Manual 49
Fluidic System

No. Precautions
fluidic diagram, can not be replaced.

There are strict tolerance requirements for lengths of the following tubes: T21 and
T20: ±3mm.
11 Tolerances for the other tubes: for length less than 50mm, the tolerance is ±1mm; for
length between 50-400mm, the tolerance is ±2mm; for length more than 400mm, the
tolerance is ±5mm.

When connecting or replacing tubes on the analyzer, never use any blades or other
12
sharp tools.

If not specifically stated, never scald any hose with hot water. TPU tube can be
13 scalded with hot water not higher than 80° before connection, without any fold
deformation. Proceed to the next process after the tube is cooled.

Before or after assembly or maintenance, keep all the hoses, connectors or fluidic
14 components intact and in good condition without any scratches, deformation or
distortion.

Thick 50 tubes cannot be used again after disconnected from valve ports or
15
connectors.

The valve ports shall be treated differently and assembled strictly in accordance with
the requirements of the fluidic diagram. Each port of the valve is marked on the valve
16
body. Three-way valve has three ports of 1, 2 and 3; two-way valve has two ports of
1 and 2.

6.5. Introduction to Sequences


Taking the Whole Blood Normal mode of instrument with throughput of 60 samples per hour
as an example:

50 Service Manual
Fluidic System

6.5.1.Measurement Sequence in Whole Blood Normal


Mode
The sequence is described as follows:
RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29
T56

Waste
container

No. Time Function

In the linkage syringe (SR), 50uL small volume syringe aspirates 9ul blood
1 0-1.3s
and the large volume syringe aspirates 900ul diluent.

2 1.0s Test the HGB blank voltage.

The negative pressure pump syringe is used to pump the waste liquid
3 1.4-4.1s generated by the sample probe wash set (SV11 is energized), and the
waste liquid is ensured throughout the process.

The linkage syringe (SR) quickly pushes the 1300uL diluent to clean the
4 1.5-3.7s
sample probe (SV02, SV04 are energized).

5 1.6-4.1s Sample probe rises up.

6 1.4-2.1s Open the beep of the end of the aspirating.

Service Manual 51
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe wash T29 T32
C18 Isolation
set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

1 3.8-5.1s The linkage syringe (SR) aspirates 650 ul diluent.

2 4.15-4.8s Sample probe rotates to WBC chamber position.

The negative pressure pump syringe aspirates waste liquid (SV10 is


3 4.15-5.25s
energized) and drains the WBC bath.

4 5.25-6.9s Drain the negative pressure pump (SV12 is energized).

5 4.8-6.1s Sample probe goes down into WBC chamber.

The linkage syringe (SR) injects 1850 ul background solution into the
6 5.3-6.1s
WBC bath

52 Service Manual
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

In the linkage syringe (SR), 8050ul large volume and 50uL small volume
1 6.2s-6.7s syringe push 400uL blood through the inner wall of the sample probe
(SV02, SV03 are energized).

2 6.9-7.9s The negative pressure pump syringe draws outside air.

The negative pressure pump syringe injects air into the isolation chamber
3 7.35-8.5s 1 through the SV010, and generates bubbles to mix the sample liquid in
the WBC bath.

The linkage syringe (SR) draws 3500 ul diluent, and the 50 uL small
4 8.1-9.8s volume syringe aspirates the 5 uL diluented sample from the WBC bath
through the sample probe.

5 8.8-9.8s Drain RBC bath (SV08 is engernized).

50uL small volume syringe aspirates 30uL diluented sample form the
6 9.9-12.6s WBC bath through a sample probe, and 8.05mL large volume syringe
aspirates 3000uL diluent.

Service Manual 53
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

The sample probe rises to the sample probe wash set position, and the
1 12.5-16s outer wall of the probe is cleaned by the sample probe wash set, and the
negative pressure pump syringe opens the SV11 to aspirate waste liquid.

2 16.1-17.1s Drain the negative pressure pump syringe (SV12 is energized).

3 15.2-16.1s 8.05ML syringe of the linkage syringe (SR) aspirates 1200 ul diluent.

4 16.2-16.9s 1130 ul syringe addes 310uL LH lyse to WBC bath.

5 16.1-17.8s Sample probe rotates to RBC chamber position.

6 17.1-17.5s The negative pressure pump syringe draws outside air.

The negative pressure pump syringe injects air into the isolation
7 17.7-19.4s chamber 1 through the SV010, and generates bubbles to mix the sample
liquid and lyse in the WBC bath.

8 19.4-19.9s Drain the negative pressure pump syringe.

54 Service Manual
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe wash T29 T32
C18 Isolation
set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

1 17.8-20.0s 8.05mL syringe aspirates 2120uL diluent.

2 18.0-19.5s Sample probe rotates to RBC chamber position.

3 20.3-21.5s 8.05mL syringe injects 2200uL diluent to WBC bath.

In the SR linkage syringe, 8050ul large volume and 50uL small volume
4 21.8-22.8s syringe push 400uL blood through the inner wall of the sample probe
(SV02, SV03 are energized).

5 20-20.4s The negative pressure pump syringe draws outside air.

Injects air into the isolation chamber 2 through the SV08, and
6 22.9-24.3s
generates bubbles to mix the sample liquid in the RBC bath.

7 23.1-24.1s 8.05mL syringe aspirates 1200uL diluent.

The sample probe rises to the sample probe wash set position, and
the outer wall of the probe is cleaned by the sample probe wash set,
8 24.4-27.7s
and the negative pressure pump syringe opens the SV11 to aspirate
waste liquid.

Service Manual 55
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

1 24.2s Test the HGB.

2 25.0s Turn on the constant current source.

3 27.7-29.4s 8.05mL syringe aspirates 2700uL diluent.

4 27.9-28.9s Drain the negative pressure pump syringe.

A negative pressure is established in the negative pressure pump


5 30.9-31.9s
syringe

6 32.9-42.9s WBC detection, WBC counting, RBC counting, PLT counting.

7 43.1-46s Cleaning of secondary bath (SV06 is energized).

8 42.9-43.9s WBC zap

9 44.9-45.9s RBC zap

10 46-46.7s Negative pressure pump syringe drain 10950ul

56 Service Manual
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe wash T29 T32
C18 Isolation
set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

1 46.7-47.3s The negative pressure pump syringe draws outside air.

The negative pressure pump syringe is pumped to the secondary bath


2 47.3-47.9s (SV09 is energized), and the zapped sample residue is backflushed
into the front pool.

3 48.3-49.2s Drain WBC bath.

4 48.4-50.4s 8.05mL syringe injects 2600uL diluent to WBC bath.

5 49.0s Turn off the constant current source.

6 49.3-49.9s Drain RBC bath.

6 50.1-51.6s Drain the negative pressure pump syringe.

8 50.5-51.5s 8.05mL syringe aspirates 2600uL diluent.

9 51.7-52.7s 8.05mL syringe injects 2600uL diluent to RBC bath.

Service Manual 57
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

1 51.9-53.6s Drain WBC bath.

2 52.8-53.8s 8.05mL syringe aspirates 2600uL diluent.

3 53.7-54.7s Drain RBC bath.

4 54.4-55.6s 8.05mL syringe injects 3000uL diluent to WBC bath.

5 55.2-56.5s Drain the negative pressure pump syringe.

6 55.7-56.9s 8.05mL syringe injects 3000uL diluent to RBC bath.

Dry the outer wall of the sample probe through a negative pressure
7 56.7-57.9s
pump syringe.

8 57.6-59.1s 8.05mL syringe aspirates 3000uL diluent.

58 Service Manual
Fluidic System

RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04

T19-C12-T18
SV01

T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe T29 T32
C18 Isolation
wash set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29

T56
Waste
container

No. Time Function

1 57.8-58.9s Sample probe rotates to horizontal sample position..

2 58.0-59.6s Drain the negative pressure syringe.

3 59-59.9s Sample probe rotates to the sample position.

2uL isolation air column into sample probe is created by the 50uL
4 59.15-59.95s
small volume syringe

6.5.2.Measurement sequence in Predilute Normal mode


Measurement sequence in Predilute Normal mode is basically the same with the sequence in
Whole Blood Normal mode, except for the sample volume. Because the blood sample has
been prediluted outside the analyzer, 303μL of blood is aspirated in the Predilute mode.

6.5.3.Measurement sequence in L-WBC/PLT mode


Compared with the sequence in Normal mode, the WBC/PLT test time of the measurement
sequence in Normal mode becomes longer. The main differences are as follows:

1. Sample mode. The Normal mode supports Whole Blood, Capillary WB and Predilute
blood mode, and the L-WBC/PLTmode only supports Whole Blood and Capillary WB mode.

2. WBC/PLT test time. The WBC/PLT test time in L-WBC/PLT is much longer than Normal
mode.

Service Manual 59
Fluidic System

6.5.4.Introduction to the Maintenance Sequences


Probe cleanser maintenance (shutdown sequence)
The locations soaked by the probe cleanser are shown below. The orange lines are the
locations soaked by the probe cleanser, and the blue lines are the locations passed by the
probe cleanser.
RT1

J1-C1-T2-C2-J2 J3-C3-T3

J4-C5-T6-C6-J5 RT2
C19 C7 C8 C9
C10
T8 T9 T10

T26
T17
1 T11 C4
SV06
2

Lyse
C11
T14
SV05 2

SV03

container
1 3

Diluent
3 1 3 1 2 3 1
T22-C14-T23
2 2 1 3 2
SV02 SV04
T19-C12-T18

SV01
T25-C15-T24

T28-C16-T27
T16

T7 T20-C13-T21
T1

T15
SPB
WBC RBC
Sample
probe wash T29 T32
C18 Isolation
set T31
(8050uL)
(1130uL)

room 3
(50uL)

T30 T33
C17
T34 T47
SV07
T37 2
T36
T35
1

Isolation Isolation
SR room 1 room 2 SV08
1 2
T39 T40-C20-T41
Shield T38
cover T48
SV09 T49
1 2

(45mL)
T42-C21-T43

T50
SV10
1 2
T44-C22-T45 T51
T52
SV11
1 2
T46 SY
C25 C24 2 1
C26 C23
T55 T54 T53

SV12
C27 C28
C29
T56

Waste
container

An enhanced probe cleanser maintenance sequence will be called every 50 times of sample
measurement (defaulted as 50, 20-200 can be set). The main difference between the
enhanced and the regular probe cleanser maintenance sequence is the soaking time. The
soaking time of enhanced maintenance is 5 minutes longer than regular maintenance.

In the Maintenance screen, the probe cleanser maintenance is defaulted as enhanced


probe cleanser maintenance.

Startup
The fluidic actions on startup are shown in the following table:

No. Startup fluidic action Description

Initialization of fluidic Initialization of valves, pumps, sampling assembly and


1
components syringe assembly.

2 Reagent self-test Checking if LH lyse and diluent is expired.

Including maintenance of all the tubes and fluidic


3 Startup maintenance
components on the analyzer.

4 Background measurement Normal measurement mode.

Standby
The instrument will enter standby status after idling for 10 to 30 minutes (defaulted as 15
minutes). After entering standby status, operations without fluidic actions can be performed
from the screen.

60 Service Manual
Fluidic System

When exiting standby, depending on the standby time, the instrument performs a different
exiting standby action, as shown in the following table.

Exit Call
No. Description
standby condition

Exit
Standby time Clean the interior and exterior of the sample probe and
1 standby
≤ 30 minutes rebuild the isolation bubble without consumption of lyse.
status 1

Exit 30 minutes < Clean the interior and exterior of the sample probe, the
2 standby Standby time WBC bath, the RBC bath, and rebuild the isolation
status 2 ≤ 3 hours bubble with consumption of lyse.

The same as fluidic maintenance on startup, including


Exit Standby
maintenance of all the tubes and fluidic components on
3 standby time > 3
the analyzer; discarding 2.7ml of LH reagent to eliminate
status 3 hours
the effects of crystal and bubbles at the inlet.

Service Manual 61
Hardware System

7. Hardware System

7.1. Overview
The hardware system consists of main control board and indicator board, but also
connecting wires between different boards and components.

7.1.1.Hardware Resources
1. 10.4 inch color display \ LVDS interface \ resolution 800 × 600 \
appearance 236mm × 177mm
Display

2. Resistive touch screen

1. TCP/IP network port

Interface 2. 4 USB ports

3. Serial communication interface

1. Capable of driving four-way two-phase stepper motor

Motor driver 2. 8W1-2 phase

3. Peak output current can reach 2.5A

1. Can read the photoelectric sensor signal correctly

2. Can achieve card recognition


Input and output
sensor
3. Reserved positive and negative pressure acquisition interface

4. Reserved barcode scanning function interface

1. Can read the converted optical WBC signal accurately


Signal processing
2. Can read the RBC/PLT signal accurately
design
3. Can read the HGB signal accurately

62 Service Manual
Hardware System

7.1.2.System Troubleshooting
Common hardware system failures can be divided into board failures, wire failures and
component failures. Generally, the troubleshooting procedures of these failures can be
found in the board troubleshooting section below. However, when the system power supply
cannot be guaranteed (such as failure to power up or immediate system self-protection after
power-up), it will be necessary to start troubleshooting from the system level. The figure
below shows the flowchart for power anomaly check.

Power supply abnormal

Is the AC power N Reconnect the


connection reliable? power plug

Reconnect
N
Is the filter connection reliable? the filter
plug

Is the fuse in the power supply N Replace


assembly working properly? the fuse

Replace the AC
Is the output pin
N power cable. If the
voltage normal after
voltage remains
the filter switch is
abnormal, replace
closed?
the filter

Y Replace the power


supply assembly

Figure 8-1 Power anomaly troubleshooting flowchart

Service Manual 63
Hardware System

7.2. Main Control Board Module


7.2.1.Main Input Signal
1) USB2.0, network port 100M (IEEE 802.3);

2) Feedback signal of the motor motion state (photoelectric sensor signal);

3) SD card signal input (SD card 2.0);

4) Communicate with PC serial port (serial port);

5) Resistive touch screen signal input (analog signal).

6) White blood cell signal WBC (analog signal);

7) Platelet signal PLT (analog signal);

8) Hemoglobin signal HGB (analog signal);

9) Signal board data input (TTL signal);

10) Barcode scanning signal input (reserved);

11) Pressure sensor signal (reserved)

7.2.2.Main Output Signal


1) Display data output (LVDS signal);

2) Barcode scanning signal input (reserved);

3) Printer data signal (serial signal);

4) Network port 100M (IEEE 802.3);

5) Communicate with PC serial port (serial port).

6) Motor motion control interface;

7) Solenoid valve control interface;

8) The indicator controls the output signal.

64 Service Manual
Hardware System

7.2.3.Function and Performance Realization

15-way solenoid valve


or without detection
4-way stepper motor

2-way reagent with


1-way air pressure

1-way waste signal

1-way liquid pump


position sensor

(reserved)
7-way motor

(reserved)

1 fan
Barcode scanning

Resistive touch screen


WBC channel
LCD screen

RBC/PLT channel
SD card

Indicator board Main control board(AM335X+FPGA) HGB test


Aspirate bracket driver board(MCU)
RS232 DB9 Printer

Network port
USB2.0
RF card

Open-vial aspirate key

DC5V(digital)
DC12V(power)
DC24V(power)
DC110V(Zap)
DC±12V(simulation)
Switching
Power filter
Grid AC220V power supply
+ switch
module

Figure 8-2 Main control board function module

7.2.4.Module Circuit Introduction


Screen display function and touch operation design

Figure 8-3 Display function module

As shown in the figure above, chip THC63LVDM83D is used to convert the RGB signals
output from the CPU to the LVDS signal of the screen. The touch screen outputs analog
signals in the X and Y directions, the analog signal is converted into a digital signal sent to
the core board by the touch screen control chip TSC2007.. The touch position is determined
by the algorithm processing results, thereby realizing the touch function.

Service Manual 65
Hardware System

Network port communication design

Figure 8-4 Network port function module

Use AR8035 to convert the RGMII signal to an MDI signal with a transmission data of 100M.

CPU and FPGA communication design

Figure 8-5 Interface function module

As shown in the figure above, the signal board FPGA will upload the signal data to the CPU
and the CPU processes the signal data. The communication between them is GPMC.

CPU and serial ports communication design

Printer

Debug serial port

Figure 8-6 AM3358 serial port function module

As shown in the figure above, the main control core A3358 communicates with the STM32
control chip and printer through the serial port.

66 Service Manual
Hardware System

STM32 and serial communication design

Barcode scanning

Debug serial port

Figure 8-7 STM32 serial port function module

As shown in the figure above, the STM32 control chip performs barcode scanning through
the serial port.

Stepper motor drive design

Figure 8-8 Stepper motor function module

Driving a stepper motor requires two circuits: 1. Driver chip; 2. Circuit that receives the
optocoupler control signal;

The driver chip converts the control signal to the rotation direction and the number of
microsteps of the motor. STM32F103 outputs two signals: rotation direction: MOTO_CW;
stepping pulse: MOTO_CLK. The driving voltage of the stepper motor is 24V; the current is
determined by VREF terminal voltage which sets the driver chip.

Current setting formula:

Pump/valve driving

Figure 8-9 Pump, valve function module

STM32F103 outputs high and low electrical level to control the CMOS tube (NDS351 and
NDT451)circuit switch to drive the pump and valve, each pump and valve corresponds to a
CMOS tube circuit.

Service Manual 67
Hardware System

Groove sensor driving

Figure 8-10 Groove sensor function module

The working principle of the groove sensor is to sense the stepping position of the motor
through the groove gap of the code disc, and output high electrical level when the groove
sensor is blocked, then pass the signal to STM32 through the logic circuit.

WBC acquisition function module


AD7091R
AD8671 10X AD8642 25X Analog to
WBC FPGA CPU
magnification magnification digital
conversion

Figure 8-11 WBC acquisition function module

WBC is the pulse signal, the cycle T=16us, the amplitude V=1mV. After 250-500 times
amplification, the amplitude is about 0.9V. The AD7091R converts these analog signals into
digital signals for FPGA acquisition and uploading them to the CPU.

RBC/PLT acquisition function module


AD7091R
AD8671 10X AD8642 25X Analog to
RBC FPGA CPU
magnification magnification digital
conversion

AD7091R
PLT Signal
AD8642 4X Analog to
magnification digital
conversion

Figure 8-12 RBC/PLT acquisition function module

RBC is the pulse signal, the cycle T=16us, the amplitude V=1mV. After 250-500 times
amplification, the amplitude is about 0.9V. The AD7091R converts these analog signals into
digital signals for FPGA acquisition and uploading them to the CPU. After the RBC signal
amplified by 250-500 times is amplified by 4 times, the PLT signal is obtained. The PLT is
also a pulse signal, the cycle T=16us, and the amplitude is about 3.6V. It is then converted
by AD7091R to digital signal for FPGA acquisition and uploading to the CPU.

68 Service Manual
Hardware System

HGB acquisition function module


AD7265B
AD8672 AD8642
Analog to
HGB 1000X about 1-2X FPGA CPU
digital
magnification magnification
conversion

Figure 8-13 HGB acquisition function module

HGB signal is a DC signal. The input amplitude is about 1.5mV, which changes to about
1.5V after amplified by 1000 times. AD7265 then convert this signal into a digital signal for
FPGA acquisition and uploading to the CPU.

7.2.5.Troubleshooting

Printer J15 J24 1-way air pressure (reserved)

USB2.0 J10 and J11 J24 1-way liquid pump (reserved)

Barcode scanning J32 J24 1 fan

Inverter J7 J24 15-way solenoid valve

Resistive touch screen J8 J31 1-way waste signal

LCD screen J9 2-way reagent with or without


Main control board(AM335X+FPGA+STM32F103) J24
detection

SD card J12
J24和J31 7-way motor position sensor

Indicator board J30


J20、J21、J22、J23 4-way stepper motor

Network port J6
J26 WBC channel

RF card J18
J27 RBC/PLT channel

Open-vial aspirate key J16


J29 HGB test

The table below lists common symptoms and relative corrections for the main control board
only from the hardware side, not including symptoms caused by software. However, many
problems will need to be tested by software.

Before troubleshooting problems related to the main control board, perform the following
checks:

1. Whether there is any loose connecting wire or unreliable connection on the main control
board;

2. Whether the bit numbers on the wires are matching the bit numbers on the main control
board sockets; whether there is any broken or damaged wire;

3. Whether the input power of board socket J1, J4 and J28 are working properly.

4. Whether the reference voltage on the board is normal;

5. Whether each work power indicator is working properly.

After the wire connections, input power and indicators are verified to be normal,
troubleshoot the problem in accordance with the following table.

Service Manual 69
Hardware System

Symptom Solution

1. Check if the power supply is working properly. If so,


proceed to the next step.

2. Check if the voltage of 5V and 3.3V (marked on the


board) on the voltage test point of the main control board is
normal, if not check the board for a short circuit.

3. Check if the backlight lights up, if not, whether the high


pressure bars are damaged.
1. Cannot startup
4. Check if the connection between the main control board
and the backlight interface and LCD screen is reliable. If the
fault disappears after re-plugging and re-attaching the
power source, then the line connection is not reliable.
Otherwise, proceed to the next step.

6. Replace the LCD screen, if the fault disappears, it is the


LCD screen component failure.

1. Check if the SD card is securely plugged in.


2. Can not load kernel at 2. Check if there is incomplete weld between the main
startup control board and the core board connector, or the chip pin
falls off with the pad.

1. Check whether the backlight power supply is normal,


8-inch screen 5V power supply, 10.4- inch screen 12V
power supply;

3. Display black screen 2. Check if the cable is loose or broken. If yes, re-plug or
replace the cable;

3. If the above faults are eliminated, gradually check and


replace the main board, Inverter board, and display screen.

1. Check if the cable is loose or broken. If yes, please


4. Touch screen cannot be re-plug or replace the cable;
used 2. If it still does not work, gradually check and replace the
main board, touch screen.

1. Check if the cable is loose or broken. If yes, please


re-plug or replace the cable;
5. Indicator does not shine
2. If it still does not work, gradually check and replace the
main board and indicator board.

6. Can not read the barcode 1. Check whether the barcode type is supported by the

70 Service Manual
Hardware System

Symptom Solution

information barcode scanner.

2. Check the scanner cable for poor contact or breakage.

3. Replace the scanner parts if the above faults have been


excluded.

1. Check the printer cable for poor contact or breakage.


7. Can not print test results 2. Replace the printer parts if the above faults have been
excluded.

Turn off the power and measure the voltage between the
two ends of the battery clip with a multimeter with with the
8. Clock reset at every
battery in place. If the measured value is less than 2.8V,
startup
then the problem is caused by a low battery, replace the
battery.

1. Check if the connecting wire of the aspirate key is loose


or broken. If so, reconnect or replace the wire.
9. No response when
pressing the aspirate key 2. If step 1 does not solve the problem, remove the aspirate
key switch plate to check if there is fluid inside. If so, clean
the fluid and reinstall the switch plate.

10. No WBC measurement Check if the optical signal line (J26) connection is reliable. If
value so, replace the main control board if there is still no value.

11 No RBC measurement Check if the RBC signal line (J27) connection is reliable. If
value so, replace the main control board if there is still no value.

12 No HGB measurement Check if the HGB signal line (J29) connection is reliable. If
value so, replace the main control board if there is still no value.

13. The motor does not work, 1. Check if the board power supply (24V, 5V, 3.3V, marked
the motor works, but motor on the board) is working properly;
failure or photocoupler failure 2. Check if the connection between the motor of the
is reported corresponding channel and the photocoupler is reliable, if
the connectors on both ends are connected properly, if the
marks on the photocoupler and motor connecting wires
match their respective locations, and if there is any broken
or damaged wire;
3. After verifying 1 and 2, try to correct the problem by
performing maintenance operations from the software
debugging screen to do single control on the corresponding

Service Manual 71
Hardware System

Symptom Solution

failure;
4. Check if the photocoupler surface of the corresponding
channel is contaminated by dust or fluids. If so, clean and
reinstall the photocoupler. If the problem is not solved,
replace this photocoupler;
5. If the problem still exists after replacing the photocoupler,
replace the main control board;
6. If the problem persists, replace the corresponding
channel motor;
7. If the problem persists, then the problem may be caused
by mechanical component failure (such as too much
friction), please troubleshoot this problem as a mechanical
problem.

14. Abnormal motor noise 1. Check if the corresponding channel motor connecting
wire is loose, broken or damaged. If so, reconnect or
replace the wire with the power off;
2. Check if any fastening screw of the mechanical
component is loose. If so, tighten this screw;
3. If both 1 and 2 can be excluded, the problem may be
caused by driver board failure. Replace the analog driver
board;
4. If the problem persists, it will be necessary to replace the
motor assembly.

15、The fluidic is not working 1. Perform maintenance operations from the software
properly debugging screen to check if the valve is opening and
closing correctly (a clap will be heard on normal open/close
of the valve). If so, then the problem is not in the valve drive,
check the fault from the fluidics.
2. If the valve is not opening and closing correctly, check if
there is any loose or broken wire or unreliable connection. If
so, reconnect or replace the connecting wire;
3. If the problem persists, use wires of other valves to
connect this valve, and check if the problem is in the valve
start circuit or in the valve itself from the Maintenance
screen (for example, if valve 2 is suspected, use wires of
valve 3 to connect valve 2; open and close valve from the
Maintenance screen; if the valve is opening and closing
correctly, then the analog driver board is damaged and

72 Service Manual
Hardware System

Symptom Solution

needs to be replaced; if the valve is not opening and closing


correctly, then the valve 2 is damaged and needs to be
replaced).

16. False alarm of level 1. Check if the connecting wire on the level sensor
status connector is loose, wet or broken. If so, disconnect and
reconnect the connector, or reconnect the connector after
cleaning the fluid, or replace the connecting wire. If not,
measure the voltage of DL and LH, the voltage should be
low (1.65-1.85V) if there is no liquid, should be high
(2.9-3.5V) with liquid.
2. Otherwise, replace the liquid level sensor assembly.

 Please wear antistatic gloves when repairing and removing boards.

 Please make sure power is off and the power cable is disconnected when mounting and
removing boards.

 Check whether the board screws are fully installed.

 Please make sure that the board and the surroundings have been cooled before the
disassembly operation.

Service Manual 73
Troubleshooting

8. Troubleshooting
Repair Guide
Trigger Related Potential
Error Related Troubleshooting
Mechanism Factors Failure
screen Procedure
1. Serial Damaged
communication Driver board communication
protocol error module
2. No header,
Driver board
jumbo frames, Replace the related
communication /
insufficient Damaged boards.
error Main control
frame length, communication
board
checksum error, module
unrecognizable
command
1. Check if the button
battery is installed on
the digital board.
Button battery /
2. If the battery is
After startup,
installed, replace the
the instrument
battery and reset
System clock time is not in the
/ date and time in the
error range of
Setup screen. Save
2000-1-1 ~
and exit and reset
2036-12-30 Main control
/ the analyzer
board
3. If the problem
persists, replace the
main contol board.
1. Make sure that
there is no error
Bubbles in
report on the reagent
tubes
setup screen.
2. Make sure there is
No reagent or
sufficient diluent in
abnormality Reagent
Diluent-related the container.
No diluent lead to Setup
tubes 3. Check if there is
insufficient screen
no dead bend or
reagent addition Leakge in tubes
leakge of the tubes
or valves
outside the
instrument.
4. Remove the cover
of the analyzer, and

74 Service Manual
Troubleshooting

Repair Guide
Trigger Related Potential
Error Related Troubleshooting
Mechanism Factors Failure
screen Procedure
check the diluent
pathway (container
cap assembly, valve,
syringe, tube
connectors, etc.)
Bubbles in 1. Make sure that
tubes there is no error
report on the reagent
setup screen.
2. Make sure there is
sufficient lyse in the
container.
3. Check if there is
No reagent or
1. Lyse-related no dead bend or
abnormality Reagent
tubes Leaking or leakge of the tubes
No LH lyse lead to Setup
2. Anti-soluble folding of lyse inside the
insufficient screen
samples related tubes instrument.
reagent addition
and valves 4. Remove the cover
of the analyzer, and
check the diluent
pathway (container
cap assembly, valve,
electromagnetic
metering pump, tube
connectors, etc.)
BNC connector 1. Check if the
of the waste indicated information
sensor is not is as expected from
connected the sensor status
screen.
Sensor
Waste bucket Waste sensor Unable to 2. Check if the
Float status Status
full assembly change the connecting wire of
screen
status correctly the waste sensor is
due to foreign correct.
matter on the 3. Check if the float is
float able to change the
status correctly.
56V voltage is Voltage 1. Check if the
Voltage Board
not within [55, Signal board & Voltage & Current
abnormal damaged
65] V Current Status screen shows

Service Manual 75
Troubleshooting

Repair Guide
Trigger Related Potential
Error Related Troubleshooting
Mechanism Factors Failure
screen Procedure
12V voltage is Status the expected
Signal board / Board
not within [11, screen information.
driver board damaged
14] V 2. Check if the
-12V voltage is voltage at the test
Board
not within [-14, Signal board port of the signal
damaged
-11] V board or driver board
is as expected.
3. Check if the
connection between
the power plate and
24V voltage is
Board the signal board or
not within [20, Driver board
damaged driver board is
30] V
normal.
4. Replace the signal
board or driver
board.
There is foreign
matter in the
bath
WBC bath The bath is not
1. Make sure there is
filled with
no foreign matter in
diluent while
the WBC bath.
measuring
2. Make sure the
HGB gain setup
Analyzer setup bath is filled with
incorrect Voltage
reagent properly.
HGB assembly &
HGB assembly 3. Verify the HGB
damaged Current
HGB blank HGB voltage is blank voltage from
Temperature Status
voltage not within [3.8, the Voltage &
sensor screen,
abnormal 4.8] V Current Status
damaged Gain
screen.
Temperature Setup
4. Verify the HGB
switch screen
gain settings from
damaged
the Gain Setup
Assembly
screen.
related Loose wire
5. Check the HGB
connections
assembly.
Temperature
sensor Loose wire
connection
Optical system Severely

76 Service Manual
Troubleshooting

Repair Guide
Trigger Related Potential
Error Related Troubleshooting
Mechanism Factors Failure
screen Procedure
blocked
Loose
Hydraulic
connection or
sensor and
sensor
connection
damaged

Related Dirt blockage or


solenoids failure

Related tubes Leakage


Damaged
Driver board
board
Damaged
Photocoupler photocoupler or
dirty surface 1. Enter the system
/ Damaged self-test interface to
Syringe motor
motor confirm the problem.
System
Syringe Related 2. Refer to the error
Loose wire Self-test
assembly error connections code to check the
screen
Motion limited wire, photocoupler,
due to motor, and motion
Drive
mechanical interference.
mechanism
interference or
other causes
Vertical 1. Enter the system
/
photocoupler self-test interface to
Aspiration Lifting motor / confirm the problem.
System
module lifting Mechanical Motion 2. Refer to the error
/ Self-test
mechanism stop interference code to check the
screen
error wire, photocoupler,
Related
Loose wire motor, and motion
connections
interference.
Horizontal 1. Enter the system
Aspiration
position / self-test interface to
module
optocoupler System confirm the problem.
horizontal
/ Horizontal Self-test 2. Refer to the error
movement /
position motor screen code to check the
mechanism
Mechanical Motion wire, photocoupler,
error
stop interference motor, and motion

Service Manual 77
Troubleshooting

Repair Guide
Trigger Related Potential
Error Related Troubleshooting
Mechanism Factors Failure
screen Procedure
Related interference.
Loose wire
connections
Reagent 1. Verify the reagent
Reagent contaminated quality.
or expired 2. If the background
PLT is too high, verify
Abnormal the impedance
shtudown channel shield
(please refer to the
treatment of
impedance channel
Background signal interference
Background
unqualified at / alarm).
abnormal
startup 3. Verify the
Analyzer tubes
cleanness of the
Bad
reaction bath and
maintenance
correct the
practice
maintenance
practice.
4. Verify there is no
leakage in tube
connections and
valves.
1. Verify the tubes of
the secondary bath
Aperture are normal.
blockage or 2. Unclog aperture in
Aperture
bad connection Service -
voltage is too WBC bath
WBC clogging between / Maintenance -
high or changes assembly
primary bath Maintenance
dramatically
and secondary interface.
bath 3. If the problem is
not resolved, perform
the overall soaking.
Aperture 1. Verify the tubes of
blockage or the secondary bath
Aperture
bad connection are normal.
voltage is too RBC bath
RBC clogging between / 2. Unclog aperture in
high or changes assembly
primary bath Service -
dramatically
and secondary Maintenance -
bath Maintenance

78 Service Manual
Troubleshooting

Repair Guide
Trigger Related Potential
Error Related Troubleshooting
Mechanism Factors Failure
screen Procedure
interface.
3. If the problem is
not resolved, perform
the overall soaking.

Service Manual 79
Mechanical System

9. Mechanical System

9.1. Overview
This section lists the locations of major analyzer components for the service personnel to
remove and replace the components.

9.1.1.Front View

Figure 9-1 Front view of the analyzer (Left is KT-60; right is KT-40)

Figure 9-2 Front view of the analyzer (Left is KT-62; right is KT-42)

1. Touch screen 2. Sample probe 3. Aspirate key

80 Service Manual
Mechanical System

Figure 9-3 Front view of the main unit (cover open)(left is KT-60/KT-40,right is KT-62/KT-42)

1. Sampling assembly 2. Fluidic valve 3. Syringe

9.1.2.Back View

Figure 9-4 Back view of the analyzer

1. Network port 2. USB port 3. Power input socket


4. Waste sensor socket 5. Diluent inlet 6. Waste outlet

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9.1.3.Left View

Figure 9-5 Left view of the analyzer(removing the left side door and sheet metal)

1. Control board 2. Reagent bottle

9.1.4.Right View

Figure 9-6 Left view of the main unit (removing the right side sheet metal)

1. Liquid valve 2. Pump 3. Isolation room


4. Liquid valve 5. Sampling assembly 6. Measurement component

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9.2. Components
9.2.1.Introduction
This section provides exploded view and parts list of the analyzer for the service personnel
to understand the relationship between the components when removing and replacing the
components.

9.2.2.Overall Unit
Exploded view(KT-60/62)

Parts list (without mounting screw)

No. Material description Remarks

1 Aspirate pump assembly /

2 Rear plate assembly /

Main unit top plate


3 /
assembly

4 Fluidic plate assembly /

5 Power assembly /

6 Circuit plate assembly /

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No. Material description Remarks

7 Maching fixing plate /

8 Main unit right panel /

9 Bottom shell assembly /

10 Front plate assembly /

Combination screw
11 /
M4X8

12 Shell assembly /

Main unit left panel


13 /
assembly

Solenoid valve bracket


14 /
assembly 3

Solenoid valve bracket


15 /
assembly 4

16 Reagent bottle /

Exploded view(KT-40/42)

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Parts list (without mounting screw)

No. Material description Remarks

1 Aspirate pump assembly /

2 Combination screw M3×12 /

3 Combination screw M3×6 /

4 Rear plate assembly

Main unit top plate


5
assembly

6 Fluidic plate assembly

7 Power assembly /

8 Circuit plate assembly /

9 Main unit right panel /

10 Maching fixing plate /

11 Bottom shell assembly /

12 Front plate assembly /

13 Combination screw M4X8

14 Shell assembly

Main unit left panel


15 /
assembly

Solenoid valve bracket


16 /
assembly 3

Solenoid valve bracket


17 /
assembly 4

18 Reagent bottle /

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9.2.3.Front Panel Assembly


Exploded view

Parts list

No. Material description Remarks


1 Protective ring /

2 Combination screw M3×6 /

3 Front panel /

4 Tube straps /

5 Reagent with or without /


detection assembly
6 Microswitch /

7 Protective ring SB-22 /

8 Pan head screw M2×10 /

9 Combination screw M4×8 /

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9.2.4.Fluidic Plate Assembly


Exploded view

Parts list

No. Material description Remarks


1 Negative pressure pump /
assembly
2 Isolator assembly /

3 Fluidic plate /

4 Tube straps /

5 Reagent with or without /


detection assembly
6 Solenoid valve bracket /
assembly-1
7 Solenoid valve bracket /
assembly-2
8 Shield cover of counting pool /

9 Isolator snap ring /

10 Protective ring /

11 Combination screw M3×10 /

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No. Material description Remarks


12 Combination screw M3×6 /

13 Sampling assembly /

9.2.5.Sampling assembly
Exploded view

Parts list

No. Material description Remarks


1 Cross head screw M3X8 /

2 Horizontal movement /
assembly
3 Vertical movement assembly /

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9.2.6.Horizontal Movement Assembly


Exploded view

Parts list

No. Material description Remarks


1 Horizontal movement /
assembly
2 X-axis baseplate /

3 Sample probe driven pulley /


shaft

4 Sample probe driven pulley /

5 Sample probe pulley /

6 Synchronous belt /

7 Sample probe active pulley /

8 Motor /

9 E-ring /

10 Combination screw M3×4 /

11 Nut M4 /

12 Sensor /

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No. Material description Remarks

13 / /

14 Horizontal guide shaft /

15 X-axis bushing /

16 X-axis slider /

17 X-axis support /

18 Limit small bracket /

19 Horizontal light barrier /

20 X-axis bushing /

21 Combination screw M3×10 /

22 Combination screw M3×6 /

23 Slider plate /

9.2.7.Vertical Movement Assembly


Exploded view

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Parts list

No. Material description Remarks


1 Nut M4 /

2 E-ring /

3 Washer combination /

4 Sensor /

5 Synchronous belt /

6 Swimming clamp /

7 Vertical guide shaft /

8 Vertical pulley shaft /

9 Sample probe driven pulley /

10 Sampling-lifting block /

11 Y-axis bushing /

12 Combination screw M3×6 /

13 Motor /

14 Y-axis baseplate /

15 Lower support block /

16 Sample probe active pulley /

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9.2.8.Shield Cover of Counting Pool


Exploded view

Parts list

No. Material description Remarks


1 Snap ring of counting pool /

2 Insulated flat pad /

3 Isolator assembly /

4 Shield cover /

RBC counting pool assembly /


5
(with aperture)

WBC counting pool assembly /


6
(with aperture)

Shield cover assembly of /


7
counting pool

8 Isolator snap ring /

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9.2.9.Rear Plate Assembly


Exploded view

Parts list

No. Material description Remarks

1 Aviation plug /

2 Combination screw M3×6 /

3 Main unit rear plate /

4 Threaded pipe assembly /

5 Combination screw M3×16 /

6 Combination screw M3×6 /

7 Combination screw M4×8 /

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9.2.10. Power assembly


Exploded view

Parts list

No. Material description Remarks

Combination screw
1 /
M3×6

Round head
2 combination screw /
M4

3 Shield cover of plug /

4 Support /

5 Filter /

6 Power /

7 Power plate /

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9.2.11. Shell Assembly


Exploded view

KT-60

Parts list
No. Material description Remarks
1 Display assembly /

2 IC card module assembly /

3 Aspirate key spring /

4 Light board /

5 KT-60 10-inch screen shell /

6 Light guide ring /

7 Rotating shaft /

8 Swipe poncho /

9 Key /

10 Plate /

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KT-40

Parts list
No. Material description Remarks
1 Display assembly /

2 PCBA board /

3 Shield cover of adapter board /

4 Combination screw M3X6 /

5 Swipe poncho /

6 Plate /

7 Aspirate key spring /

8 Light guide ring /

9 Key /

10 Light board /

11 KT-40 8-inch screen shell /

12 Rotating shaft /

13 IC card module assembly /

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9.3. Removal and Installation


9.3.1.Tools
The following tools may be needed during removal and replacement of components:

 Crosshead screwdriver (107)

 Flathead screwdriver

 Tweezers

 Pliers

 Cutting pliers

 Hex wrench set

9.3.2.Preparation for Disassembly


Before disassembling the analyzer, please make the following preparations:

 Stop the blood tests. Adjust the sample probe to the horizontal sampling position.
Shut down the analyzer and disconnect all the connections with accessories and
peripherals.

 Disconnect the external power supply.

 All the analyzer components and surfaces are potentially infectious. Take proper
protective measures during operation and maintenance.

 The reagents are irritating to eyes, skin and mucosa. 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, seek medical advice; if the reagents accidentally spill into your eyes, wash
them off with plenty of water and immediately go to see a doctor.

 Please eliminate static electricity before disassembly. While removing the components
with electrostatic sensitive mark, please wear protective equipment such as an
antistatic wrist strap or antistatic gloves to avoid electro-static discharge damage to the
components.

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 During reassembly, please connect the wires correctly and keep them in proper
positions to avoid short circuit caused by damaged wires.

 Use screws of suitable models during reinstallation. Using wrong screws may result in
equipment damage. Furthermore, during usage after reinstallation, a wrong screw may
become loose and fall off, resulting in unexpected product damage or personal injury.

 Please disassemble the equipment in the correct order. Failure to do so may result in
irreversible damage to the equipment.

 Please make sure all connections have been disconnected before disassembling the
components. Be careful not to break the wires or the connectors during disassembly.

 Please store the removed screws and other parts in separate places for reinstallation
purpose. Be careful not to drop, contaminate or lose these parts.

 During disassembly, separate the materials by module to avoid misusing or missing


materials during reassembly.

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

9.4. Disassembling the Main Unit

 During the disassembly, make sure the site is smooth without foreign materials to avoid
screen scratches.
 All operations must be done by professionals. Insulating gloves must be worn when
servicing.
 After assembly, check all the fluidic tubes. Folding is strictly prohibited.

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9.4.1.Removing the Top Plate Assembly


As shown in the figure below, place the analyzer on the table, unscrew the two M3×6 combination
screws, place the handle on the top plate, push it toward the rear plate, and then lift the top plate
upwards. Unplug the micro thermal recorder cable and remove the top plate.

9.4.2.Removing the Left/Right Plate Assembly


1) Perform Section 10.4.1 and remove the top plate assembly;

2) Remove the two M3×6 combination screws and remove the right plate assembly as shown
below. Remove the two M3×6 combination screws and the two M3X12 combination screws at
the reagent compartment, and remove the left plate assembly.

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9.4.3.Removing the Power Plate Assembly


1) Unscrew the 6 M3×6 combination screws and power plate. Remove the cables and
ground wires connected with the power plate.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections are correct.

3. Verify normal operations by starting the analyzer.

 During installation, verify that the ground wire is connected to the correct ground pin
properly.

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9.4.4.Removing the Rear Plate


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Execute section 9.4.2 and remove the left/right side plate assembly;

3) Perform Section 9.4.3 and remove the power plate assembly;

4) As shown in the figure below, unplug all the cables on the main control board, unscrew
the two M3×6 combination screws and the six M4×8 combination screws, and remove the
rear plate.

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9.4.5.Removing the Front Shell Assembly


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the left/right plate assembly;

3) Unscrew the six M3×8 combination screws as shown below, remove the front shell
assembly, and unplug the display assembly and the cable on the light board.

Left is KT-60/KT-62; right is KT-40/KT-42

4) Unplug the cable connector of the front shell assembly from the main control board;

9.4.6.Shield Cover of RBC and WBC Counting Pool Repair


Assembly
1) Perform section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) As shown in the figure below, unscrew the three M3×6 combination screws and remove
the shield cover;

4) As shown in the figure below, unplug the shield line on the side of the counting pool and
all the pipes below, and remove the counting pool assembly from the snap ring.

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Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections are correct.

3. Verify normal operations by starting the analyzer.

 Before removing the counting pool shield box, please adjust the sample probe position,
so that the sample probe leaves the shield box. Otherwise the sample probe may bend
or hurt the operator.

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9.4.7.Removing the Aperture


1) Follow step 2 and 3 in Section 9.4.6 to remove the RBC shield cover.

2) As shown below, remove the M3×18 screws to remove the compression cap, and use
tweezers to remove the washer and aperture.

Note: Use angled tweezers to push the aperture out from the center of the RBC
counting pool.

 Before removing the counting pool shield box, please adjust the sample probe position,
so that the sample probe leaves the shield box. Otherwise the sample probe may bend
or hurt the operator.

 When installing the aperture, make sure that the concave of the sensor is facing the
center of the RBC counting pool.

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9.4.8.Replacing the Isolator


1) Follow step 1-3 in Section 9.4.6 to remove the right door and the RBC shielding cover.

2) As shown below, remove the isolator from the snap ring.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections are correct.

3. Verify normal operations by starting the analyzer.

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9.4.9.Removing the Right Plate Solenoid Valve Assembly


1) Perform section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) Remove the pipe in the middle of the pinch valve as shown below, unscrew the two
M3×6 combination screws, remove the electromagnet pinch valve assembly and pull
the joint out of the hole.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the electrical connections are correct.

3. After startup, press the “ ” button from the system menu, select “Service” → “Self-test”
→ “Valve Self-test” and click on the number (which is printed on the fluidics separator) to
see if the corresponding valve is working correctly.

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9.4.10. Removing the Front Valve Assembly


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) Perform Section 9.4.5 and remove the front shell assembly;

4) Unplug the pipe on the valve to be repaired as shown below, and then unscrew the two
M3×6 combination screws from the fixing plate, remove the valve assembly to be
repaired and pull the connector out of the hole.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections and the electrical connections are correct.

3. After startup, press the “ ” button from the system menu, select “Service” → “Self-test”
→ “Valve Self-test” and click on the number (which is printed on the fluidics separator) to
see if the corresponding valve is working correctly.

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9.4.11. Removing the Pump


1) Perform the 9.4.1 section and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right side panel assembly;

3) Perform Section 9.4.5 and remove the front shell assembly;

4) As shown in the figure below, unplug the pipe from the pump, then unscrew the four
M3×16 combination screws, remove the pump assembly and pull the connector out of
the hole.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections and the electrical connections are correct.

3. Verify normal operations by starting the analyzer.

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9.4.12. Removing the Waste Pump Assembly


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) Perform Section 9.4.5 and remove the front shell assembly;

4) Unplug the pipe on the vacuum chamber, then unscrew the four M3×16 screws, remove
the pump assembly and pull the connector out of the hole.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections and the electrical connections are correct.

3. After startup, press the “ ” button from the system menu, Click on the waste pump
self-test function and see if it is working correctly..

4. Verify normal operations by starting the analyzer.

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9.4.13. Removing the Sample Probe Wash Set


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) Perform Section 9.4.5 and remove the front shell assembly;

4) After startup, press the “ ” button from the system menu, select “Service” →
“Sample Probe Debug”. Click on the “Initial Position”.

5) As shown below, remove the clamp and the sample probe wash set. Disconnect the
tube from the wash set.

Installation:

Reverse the removal procedure.

Verification:

1. Verify the tube connections are correct.

2. After startup, press the “ ” button from the system menu, select “Service” → “Sample
Probe Debug” to verify the three positions of the sample probe (“Initial Position”, “Upper
Position”, “Middle Position” and “Lower Position” of “RBC Bath” and “WBC Bath”) and
ensure the reliable operation of the sample probe.

3. Start the analyzer and perform the sample probe cleaning sequence. Check if any fluid
flows out from the bottom of the sample probe wash set.

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9.4.14. Replacing the Sample Probe


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) Perform Section 9.4.5 and remove the front shell assembly;

4) After startup, press the “ ” button from the system menu, select “Service” →
“Sample Probe Debug”. Click on the “Initial Position”.

5) As shown below, remove the clamp and the sample probe wash set. Disconnect the
tube from the wash set.

6) As shown below, remove the tubes from the sample probe. Remove the 2 M3×6 screws
and the T-type press plate, and remove the sample probe.

Installation:

Reverse the removal procedure.

Verification:

1. Verify the tube connections are correct.

2. After startup, press the “ ” button from the system menu, select “Service” → “Sample
Probe Debug” to verify the three positions of the sample probe (“Initial Position”, “Upper
Position”, “Middle Position” and “Lower Position” of “RBC Bath” and “WBC Bath”) and
ensure the reliable operation of the sample probe.

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9.4.15. Removing the Sampling Assembly


1) Perform Section 9.4.1 and remove the top plate assembly;

2) Perform Section 9.4.2 and remove the right plate assembly;

3) Perform Section 9.4.5 and remove the front shell assembly;

4) Perform Section 9.4.13 and remove the clamp and the sample probe wash set.

5) As shown below, unscrew the 4 M3×6 screws, and remove the vertical movement
assembly outward.

6) As shown in the figure below (hidden front plate assembly, plate assembly), unscrew
the five M3×12 hex socket screws, remove the horizontal movement assembly outward,
and unplug the motor connector cable and sensor connector cable.

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Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the tube connections and the electrical connections are correct.

3. After startup, press the “ ” button from the system menu, select “Service” → “Sample
Probe Debug” to verify the three positions of the sample probe (“Initial Position”, “Upper
Position”, “Middle Position” and “Lower Position” of “RBC Bath” and “WBC Bath”) and
ensure the reliable operation of the sample probe.

4. Verify normal operations by starting the analyzer.

9.4.16. Replacing the Thermal Recorder


1) Follow step 1 in Section 9.4.1 to remove the top plate.

2) Disconect all the cable connectors on the recorder.

3) Open the recorder cover and unscrew the M2.5 screw until the recorder can be
removed from the square hole on the left door.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the cable connections are correct.

3. Verify normal operations by starting the analyzer.

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9.4.17. Removing the Indicator board PCBA


1) Follow step 1-4 in Section 9.4.5 to remove the front shell assembly, and put it on the
table. Remove the cable connector from the indicator.

2) As shown below, KT-60/KT-40: unscrew the 2 M3×6 combination screws and remove
the plate and the spring; unscrew the 3 M3×6 combination screws, remove the indicator
board PCBA. KT-62/KT-42: unscrew the 2 M3×6 combination screws and remove the
indicator board PCBA.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the cable connections are correct.

3. Start the analyzer and verify the indicators can be illuminated.

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9.4.18. Removing the Touch Screen Inverter(Only for


KT-60/KT-62 models)
1) Follow step 1-4 in Section 9.4.5 to remove the front shell assembly, and put it on the
table. Remove the cable connector from the indicator.

2) As shown below, unscrew the 2 M3×6 combination screws, remove the inverter.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the cable connections are correct.

3. Start the analyzer and verify normal operations of the touch screen.

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9.4.19. Removing the LCD Module


1) Follow step 1-4 in Section 9.4.5 to remove the front shell assembly, and put it on the
table. Remove the cable connector from the indicator.

2) As shown below, unscrew the 6 M3×8 combination screws which fasten the LCD
module, and the 2 screws which fasten the strap. Remove the LCD module and
disconnect all the cables from the screen.

Left is KT-60/KT-62; Right is KT-40/KT-42

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the cable connections are correct.

3. Start the analyzer and verify that the screen is working correctly.

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9.4.20. Removing the Touch Screen


1) Follow step 1-4 in Section 9.4.5 to remove the front shell assembly, and put it on the
table. Remove the cable connector from the indicator.

2) As shown below, remove the cable from the touch screen, unscrew the 4 M3×8
combination screws which fasten the LCD module, and remove the touch screen
assembly (without disconnecting the cables).

Left is KT-60/KT-62; Right is KT-40/KT-42

3) Remove the touch screen from the front shell.

Installation:

Reverse the removal procedure.

Verification:

1. Check if each connecting wire of the touch screen is locked.

2. Check if all the components are installed and fastened in position.

3. Calibrate the touch screen.

4. Start the analyzer and verify normal operations of the touch screen.

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9.4.21. Removing the Scan Head Adapter Board


1) Follow step 1-4 in Section 9.4.5 to remove the front shell assembly, and put it on the
table. Remove the cable connector from the indicator.

2) Unscrew the 4 M3×6 combination screws, remove the swipe poncho.

3) Unscrew the 4 M2×6 combination screws, remove the adapter board.

Installation:

Reverse the removal procedure.

Verification:

1. Check if all the components are installed and fastened in position.

2. Verify the cable connections are correct.

3. Verify normal operations by starting the analyzer.

4. Open the barcode scanning interface to verify that it can scan correctly.

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Debugging

10. Debugging

10.1. Sample Probe Position Adjustment


10.1.1. Sample Probe to the Center of the WBC Bath

1) Remove the shield cover. Press the “ ” button, select “Service” → “Sample Probe
Debug”, and then click “Initial Position”, the sample probe is reset. Click “WBC Bath” →
“Middle Position”, check if the sample probe is located above the center of the WBC
bath, otherwise set the compensation steps for “X Motor To WBC”, and then click
“Save”.

Sample probe to the WBC bath

2) Click “Initial Position” → “WBC Bath” to check if the position is adjusted in place, or
repeat the above operations until the probe tip is adjusted to the center of the WBC
bath.

3) Install the shield cover. Use the same method to see if the sample probe may contact
with the shield cover, otherwise re-adjust the sample probe position.

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Debugging

10.1.2. Sample Probe to the Center of the RBC Bath

1) Remove the shield cover. Press the “ ” button, select “Service” → “Sample Probe
Debug”, and then click “Initial Position”, the sample probe is reset. Click “RBC Bath” →
“Middle Position”, check if the sample probe is located above the center of the RBC
bath, otherwise set the compensation steps for “X Motor To RBC”, and then click
“Save”.

Sample probe to the RBC bath

2) Enter the sample probe debugging interface again, click “Initial Position” → “RBC Bath”
to check if the position is adjusted in place, or repeat the above operations until the
probe tip is adjusted to the center of the RBC bath.

3) Install the shield cover. Use the same method to see if the sample probe may contact
with the shield cover, otherwise re-adjust the sample probe position.

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Debugging

10.1.3. Sample Probe Horizantal Aspiration Position

1) Remove the shield cover. Press the “ ” button, select “Service” → “Sample Probe
Debug”, and then click “Initial Position”, the sample probe is reset. Click “RBC Bath” →
“Lower Position”, check if the sample probe reaches the position of the bath in the RBC
bath, otherwise set the compensation steps for “Y Motor To WBC(RBC)”, and then click
“Save”.

The sample probe is


in the red line area

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Debugging

10.2. HGB Blank Voltage Setup


1) Before setting the HGB blank voltage, prime the liquid system. Ensure that the fluid
path and the WBC bath priming are normal.

2) Press the “ ” button and select “Setup” → “Gain Setup”, click the HGB “Set Value”
box and input the value to adjust the blank voltage to be within 4.5±0.1V.

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Debugging

10.3. RBC Gain Setup


1) Prepare a control with normal value. Keep it at room temperature for 15 minutes after
taking out from the refrigerator, and then mix it well by back and forth rubbing the
collection tube with both hands.

2) Present the control to the sample probe. Press the aspirate key to start analysis.

3) After the analysis, check the MCV value, which should be close to the target value of
the control MCV; Enter the gain setup interface and set the RBC set value.

4) In the gain setup interface, set the RBC set value and run the QC analysis again.
Repeat the above operations until the peak value is close to the target value of the
control.(Reference: RBC gain value is generally between 40 and 45)

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Debugging

10.4. WBC Gain Setup


1) Remove the 7um standard solution from the refrigerator and mix it by shaking; first add
2mL of the diluent to the bullet, then add two drops of the standard solution (about 50uL)
and mix well to select the whole blood mode measurement.

2) After the test is completed, check the WBC information diagram on the main interface.
The peak value of the graph is around the horizontal coordinate fL155. The peak value
of the graph is to the left, and the WBC gain coefficient is increased. When the peak
value of the graph is right, the WBC gain coefficient is reduced.

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Commissioning and Verification after Servicing

11. Commissioning and Verification


after Servicing

Commissioning
Part Name Material Code Requirements after Confirmation
replacement

Check the corresponding


Main control board Version information is
P02.05.505026 version information from the
assembly correct
“Version Info.” screen

Check the corresponding


Kernel version
Core board P01.50.000370 version information from the
information is correct
“Version Info.” screen

1. Backup the data before


SD card replacing the SD card (if
application possible). Software version
P01.91.924083
component (60 information is correct
speed) 2. Restore the configuration
data.

1. Backup the data before


SD card replacing the SD card (if
application possible). Software version
P01.91.924082
component (40 information is correct
speed) 2. Restore the configuration
data.

Self-test diluent syringe in


Aspirate pump
P02.15.503033 the " System Self-Test " Fault free
assembly
interface

Self-test waste pump


Negative pressure
P02.15.503032 syringe in the " System Fault free
pump assembly
Self-Test " interface

Sampling drive P02.15.503041 1. Move the sampling 1. Sampling


assembly assembly horizontally and assembly self-test is
vertically to ensure that the fault free.
Sample probe sampling line is
P12.15.503016
wash set unobstructed with no folding 2. Reproducibility

Service Manual 125


Commissioning and Verification after Servicing

Commissioning
Part Name Material Code Requirements after Confirmation
replacement

and interference with the qualified.


preamplifier, fluidics
separator.

2. Ensure that the sample


tube is not squeezed or
deformed at the line straps.

3. Ensure that there is no


folding or interference when
the sample probe wash set
fluid line is moving
horizontally or vertically in
Sample probe P11.16.000212
the sampling assembly.

4. The orientation of the


aspiration hole of the
sample probe must be
correct.

5. Commissioning of the
position between the
sample probe and the
WBC/RBC bath

6. Recalibration

1. Commissioning of the
position between the
sample probe and the bath.

2. The waste tube of the


RBC counting pool bath needs to be wrapped in Reproducibility
module(with P02.15.505082 the vertical direction and qualified.
aperture) cannot be folded.

3. Perform RBC gain


calibration

4 Recalibration

1. Commissioning of the 1. Reproducibility


WBC counting qualified.
position between the
pool module(with P02.15.505081
sample probe and the bath. 2. HGB background
aperture)
2. The waste tube of the voltage is 4.5V.

126 Service Manual


Commissioning and Verification after Servicing

Commissioning
Part Name Material Code Requirements after Confirmation
replacement

bath needs to be wrapped in


the vertical direction and
cannot be folded.

3. Perform HGB gain


calibration

2-way solenoid 1. Verify that the


P12.15.503013
valve assembly Check valve 1-16 in turn in orientation of the
the “Valve self-test” inlet/outlet is correct.
3-way solenoid interface 2. The hose shall be
P12.15.503014
valve assembly fully inserted.

Verify normal
KT-40/KT-42 touch Perform touch screen
P11.72.000032 operations of the
screen calibration
touch screen

Verify normal
KT-60/KT-62 touch Perform touch screen
P11.72.000041 operations of the
screen calibration
touch screen

Display screen
P11.72.000042
(KT-60/KT-62)

Display screen
P11.72.000031 / Can display properly
(KT-40/KT-42)

Inverter
P11.50.000014
(KT-60/KT-62)

Set time and date in the


Button battery “Date/Time Setup” interface. After startup, the date
P11.59.000002
CR2032\3.0V\Φ20 Save the settings and remains the same
restart the analyzer.

Check the power supply


Switching power
P01.58.000062 output voltage before the The voltage is normal
supply
instrument is powered on

Power filter P01.58.000039 / Startup normally

Photoelectric P02.15.505062 Check the sensor blocking Check if it is blocked

Service Manual 127


Commissioning and Verification after Servicing

Commissioning
Part Name Material Code Requirements after Confirmation
replacement

sensor assembly status in the “Status - according to the


Sensor” interface. fluidic priming state.

Microswitch 1. The [Aspirate] key


P02.15.505048 /
assembly is working properly.

Indicator board The indicator is


P01.47.000252 /
assembly displayed normally.

See Section 7.5.4


See Repair Precautions for
Analyzer tubes Spare Parts / Assembly and
List Service in the service
manual.

128 Service Manual


Service BOM

12. Service BOM

Part No. Part Name

P01.58.000062-00 Switching power supply

P01.58.000039-00 Power filter

P01.57.000011-00 Fuse

P01.91.924083-00 SD card application component (60 speed)

P01.91.924082-00 SD card application component (60 speed)

P02.05.505026-00 Main control board assembly

P01.50.000370-00 Core board

P02.15.503033-01 Aspirate pump assembly

P02.15.503032-01 Negative pressure pump assembly

P02.15.505082-00 RBC counting pool module(with aperture)

P02.15.505081-00 WBC counting pool module(with aperture)

P12.15.503013-00 2-way solenoid valve assembly

P12.15.503014-00 3-way solenoid valve assembly

P12.15.503017-00 Isolator

P02.15.505005-00 Sampling body assembly

P11.16.000212-02 Sample probe

P12.15.503016-00 Sample probe wash set

P02.15.505048-00 Microswitch assembly

P01.47.000252-00 Indicator board assembly

P11.72.000032-03 8-inch touch screen

P11.72.000041-00 Touch screen

Service Manual 129


Service BOM

Part No. Part Name

P11.72.000031-00 Display screen(KT-40/KT-42)

P11.72.000042-01 Display screen(KT-60/KT-62)

P01.50.000364-00 Micro thermal recorder

P11.50.000014-00 Inverter

P01.08.000021-00 O-ring

P11.01.000131-00 Reagent detector

P01.09.500056-00 Filter

P01.09.100055-00 3.2TPU tube

P01.09.100057-00 Black transit tube

P01.09.100059-00 2.4TPU tube

P01.09.100060-00 1.6EVA tube

P01.09.100062-00 2.0TPU tube

P11.09.100019-00 Polyurethane tube

P11.09.100028-00 Polyurethane tube

P11.09.100033-00 Hose

130 Service Manual


Appendix

13. Appendix

Appendix A Fluidic Diagram

Appendix B Connection and Tube

Position
Name in
Material in the
No. the Part No. Name and Description
Type Fluidic
Diagram
Diagram

SR
1 Syringe (1130*805 P02.15.503033-00 Aspirate pump assembly C1&D2
0*50uL)

Negative
2 pressure SY(45mL) P02.15.503032-00 Negative pressure pump assembly E7&E83
pump

WBC counting pool assembly(with


3 WBC bath WBC P02.15.503005-00 C3
aperture)

4 RBC bath RBC P02.15.503004-00 RBC counting pool assembly(with C5

Service Manual 131


Appendix

Position
Name in
Material in the
No. the Part No. Name and Description
Type Fluidic
Diagram
Diagram

aperture)

Sample
7 SPB P11.16.000212-02 Sample probe C3
probe

Sample Sample
8 probe probe P12.15.503016-00 Sample probe wash set assembly C3
wash set wash set

Isolation
Isolation
9 chamber P12.15.503017-00 Isolator (without strainer) D3
chamber
1

Isolation P12.15.503017-00
Isolation
10 chamber Isolator (without strainer) D5
chamber
2

Isolation P12.15.503017-00
Isolation
11 chamber Isolator (without strainer) C7
chamber
3

Solenoid
12 SV01 P02.15.503014-00 3-way solenoid valve assembly B1
valve

Solenoid P02.15.503014-00
13 SV02 3-way solenoid valve assembly B2
valve

Solenoid P02.15.503014-00
14 SV03 3-way solenoid valve assembly B2
valve

Solenoid P02.15.503014-00
15 SV04 3-way solenoid valve assembly B2
valve

Solenoid P02.15.503014-00
16 SV05 3-way solenoid valve assembly B3
valve

Solenoid
17 SV06 P02.15.503013-00 2-way solenoid valve assembly B5
valve

Solenoid P02.15.503013-00
18 SV07 2-way solenoid valve assembly D7
valve

Solenoid P02.15.503013-00
19 SV08 2-way solenoid valve assembly D6
valve

Solenoid P02.15.503013-00
20 SV09 2-way solenoid valve assembly D7
valve

132 Service Manual


Appendix

Position
Name in
Material in the
No. the Part No. Name and Description
Type Fluidic
Diagram
Diagram

Solenoid P02.15.503013-00
21 SV10 2-way solenoid valve assembly E7
valve

Solenoid P02.15.503013-00
22 SV11 2-way solenoid valve assembly E6
valve

Solenoid P02.15.503013-00
23 SV12 2-way solenoid valve assembly E7
valve

Reagent
24 RT1 P11.01.000131-00 Reagent detector A4
test

Reagent
25 RT2 P11.01.000131-00 Reagent detector A6
test

26 Tube T1 P01.09.100057-00 Black transit tube C1

27 Tube T2 P01.09.100060-00 1.6EVA tube A2

28 Tube T3 P01.09.100060-00 1.6EVA tube A6

29 Tube T4 P11.09.100033-00 Hose B7

30 Tube T5 P01.09.100044-00 PP tube B7

31 Tube T6 P01.09.100060-00 1.6EVA tube A3

32 Tube T7 P01.09.100059-00 2.4TPU tube C1

33 Tube T8 P01.09.100059-00 2.4TPU tube A3

34 Tube T9 P01.09.100059-00 2.4TPU tube A5

35 Tube T10 P01.09.100059-00 2.4TPU tube A6

36 Tube T11 P01.09.100059-00 2.4TPU tube B7

37 Tube T12 P01.09.100033-00 Hose B7

38 Tube T13 P11.09.100044-00 PP tube B7

39 Tube T14 P01.09.100059-00 2.4TPU tube B2

40 Tube T15 P01.09.100059-00 2.4TPU tube C2

41 Tube T16 P01.09.100059-00 2.4TPU tube B2

42 Tube T17 P01.09.100059-00 2.4TPU tube B5

43 Tube T18 P01.09.100028-00 Polyurethane tube B3

44 Tube T19 P01.09.100019-00 Polyurethane tube C3

Service Manual 133


Appendix

Position
Name in
Material in the
No. the Part No. Name and Description
Type Fluidic
Diagram
Diagram

45 Tube T20 P01.09.100059-00 2.4TPU tube B2

46 Tube T21 P01.09.100060-00 1.6EVA tube B2

47 Tube T22 P01.09.100059-00 2.4TPU tube B4

48 Tube T23 P01.09.100062-00 2.0TPU tube B4

49 Tube T24 P01.09.100059-00 2.4TPU tube B3

50 Tube T25 P01.09.100062-00 2.0TPU tube C3

51 Tube T26 P01.09.100059-00 2.4TPU tube B5

52 Tube T27 P01.09.100059-00 2.4TPU tube B5

53 Tube T28 P01.09.100062-00 2.0TPU tube C5

54 Tube T29 P01.09.100019-00 Polyurethane tube C4

55 Tube T30 P01.09.100019-00 Polyurethane tube C4

56 Tube T31 P01.09.100019-00 Polyurethane tube C4

57 Tube T32 P01.09.100019-00 Polyurethane tube C4

58 Tube T33 P01.09.100019-00 Polyurethane tube C4

59 Tube T34 P01.09.100019-00 Polyurethane tube C4

60 Tube T35 P01.09.100019-00 Polyurethane tube D5

61 Tube T36 P01.09.100019-00 Polyurethane tube D4

62 Tube T37 P01.09.100019-00 Polyurethane tube D5

63 Tube T38 P11.09.100028-00 Polyurethane tube D4

64 Tube T39 P11.09.100028-00 Polyurethane tube D5

65 Tube T40 P11.09.100019-00 Polyurethane tube D6

66 Tube T41 P11.09.100028-00 Polyurethane tube D6

67 Tube T42 P11.09.100019-00 Polyurethane tube D6

68 Tube T43 P11.09.100028-00 Polyurethane tube D6

69 Tube T44 P11.09.100019-00 Polyurethane tube E6

70 Tube T45 P11.09.100028-00 Polyurethane tube E6

71 Tube T46 P11.09.100028-00 Polyurethane tube E4

72 Tube T47 P11.09.100028-00 Polyurethane tube C7

134 Service Manual


Appendix

Position
Name in
Material in the
No. the Part No. Name and Description
Type Fluidic
Diagram
Diagram

73 Tube T48 P11.09.100028-00 Polyurethane tube D7

74 Tube T49 P11.09.100028-00 Polyurethane tube D7

75 Tube T50 P11.09.100028-00 Polyurethane tube D7

76 Tube T51 P11.09.100028-00 Polyurethane tube E7

77 Tube T52 P11.09.100028-00 Polyurethane tube E7

78 Tube T53 P11.09.100028-00 Polyurethane tube E7

79 Tube T54 P11.09.100028-00 Polyurethane tube E6

80 Tube T55 P11.09.100055-00 3.2TPU tube E6

81 Tube T56 P11.09.100055-00 3.2TPU tube F5

Transit Transit tube


82 J1 P11.09.100057-00 A2
tube

Transit P11.09.100057-00 Transit tube


83 J2 A2
tube

Transit P11.09.100057-00 Transit tube


84 J3 A6
tube

Transit P11.09.100057-00 Transit tube


85 J4 A2
tube

Transit P11.09.100057-00 Transit tube


86 J5 A3
tube

Straight-through tube connector -


87 Connector C1 P01.09.500058-00 A2
medium – small(PVDF)

P01.09.500058-00 Straight-through tube connector -


88 Connector C2 A2
medium – small(PVDF)

P01.09.500058-00 Straight-through tube connector -


89 Connector C3 A6
medium – small(PVDF)

Straight-through tube connector -


90 Connector C4 P01.09.500052-00 B7
large - small

P01.09.500058-00 Straight-through tube connector -


91 Connector C5 A3
medium – small(PVDF)

P01.09.500058-00 Straight-through tube connector -


92 Connector C6 A3
medium – small(PVDF)

Service Manual 135


Appendix

Position
Name in
Material in the
No. the Part No. Name and Description
Type Fluidic
Diagram
Diagram

93 Connector C7 P11.09.500004-00 Threaded tube connector A6

94 Connector C8 P11.09.500018-00 Threaded tube connector nut A6

95 Connector C9 P11.09.700002-00 Threaded tube connector fixing cover A6

96 Connector C10 P01.09.700007-00 Threaded tube connector cap A6

Straight-through tube connector -


97 Connector C11 P01.09.500053-00 B7
large - medium (DC-1)

98 Connector C12 P01.09.500051-00 Straight-through tube connector B3

Straight-through tube connector -


99 Connector C13 P01.09.500058-00 B2
medium – small(PVDF)

100 Connector C14 P01.09.500051-00 Straight-through tube connector B4

101 Connector C15 P01.09.500051-00 Straight-through tube connector B3

102 Connector C16 P01.09.500051-00 Straight-through tube connector B5

T-type tube
103 Connector C17 P11.09.600009-00 C4
connector-medium(PVDF)

T-type tube
104 Connector C18 P11.09.600009-00 C4
connector-medium(PVDF)

105 Connector C19 P01.09.800021-00 T-type tube connector A5

106 Connector C20 P01.09.500051-00 Straight-through tube connector D6

107 Connector C21 P01.09.500051-00 Straight-through tube connector D6

108 Connector C22 P01.09.500051-00 Straight-through tube connector E6

109 Connector C23 P11.09.500004-00 Threaded tube connector E6

110 Connector C24 P01.09.500016-00 Threaded tube connector nut E6

111 Connector C25 P11.09.700003-00 Threaded tube connector fixing cover E6

112 Connector C26 P01.09.500055-00 Threaded tube connector cap E6

113 Connector C27 P01.09.500050-00 Connector F5

114 Connector C28 P01.09.700003-00 Threaded tube connector fixing cover F5

115 Connector C29 P01.09.500016-00 Threaded tube connector nut F5

136 Service Manual


Appendix

Appendix C Hardware Block Diagram

15-way solenoid valve


or without detection
4-way stepper motor

2-way reagent with


1-way air pressure

1-way waste signal

1-way liquid pump


position sensor

(reserved)
7-way motor

(reserved)

1 fan
Barcode scanning

Resistive touch screen


WBC channel
LCD screen

RBC/PLT channel
SD card

Indicator board Main control board(AM335X+FPGA) HGB test


Aspirate bracket driver board(MCU)
RS232 DB9 Printer

Network port
USB2.0
RF card

Open-vial aspirate key

DC5V(digital)
DC12V(power)
DC24V(power)
DC110V(Zap)
DC±12V(simulation)
Switching
Power filter
Grid AC220V power supply
+ switch
module

Service Manual 137


Appendix

Appendix D Commissioning and Verification Form

Product Model Serial Number

No. Inspection Item Description Requirement Result Conclusion

Refer to related
Electrical Power cable □OK □PASS
1 graphic files in the
connection connection □NG □FAIL
appendix

Red indicates
problems, green
□OK □PASS
2 Indicator color Color indicates OK,
□NG □FAIL
orange indicates
standby

Alarms when □OK □PASS


3 Indicator sound Sound
problems exist □NG □FAIL

Touchscreen
Touchscreen □OK □PASS
4 Touchscreen calibration
calibration □NG □FAIL
completed

The date and time


□OK □PASS
5 Time and date Enter time and date are entered
□NG □FAIL
correctly

Version and
□OK □PASS
6 Version configuration Is the latest version
□NG □FAIL
information

Syringe and Syringe and


sampling sampling □OK □PASS
7 Normal operation
mechanism mechanism □NG □FAIL
self-test self-test

□OK □PASS
8 Valves self-test Valves Normal operation
□NG □FAIL

Adjustment of the
Refer to
Mechanical relative position
Mechanical □OK □PASS
9 position between the
position □NG □FAIL
adjustment sample probe and
adjustment
the WBC bath

138 Service Manual


Appendix

Product Model Serial Number

No. Inspection Item Description Requirement Result Conclusion

Adjustment of the
Refer to
Mechanical relative position
Mechanical □OK □PASS
10 position between the
position □NG □FAIL
adjustment sample probe and
adjustment
the RBC bath

Counting
Bubbles in the □OK □PASS
11 channel No bubbles
sample tube or not □NG □FAIL
measurement

Counting
Fluid residue on the □OK □PASS
12 channel No residue
sample probe □NG □FAIL
measurement

The sample probe


Counting is below the liquid
Normal down □OK □PASS
13 channel level and has no
position □NG □FAIL
measurement contact with the
counting pool

Counting Bubbles in the


□OK □PASS
14 channel sample supple tube No bubbles
□NG □FAIL
measurement or not

Counting
Bubbles in the Bubbles in the □OK □PASS
15 channel
WBC bath or not WBC bath □NG □FAIL
measurement

Counting
Bubbles in the RBC Bubbles in the □OK □PASS
16 channel
bath or not RBC bath □NG □FAIL
measurement

Counting
□PASS
17 channel Aperture voltage [16, 21]V
□FAIL
measurement

Counting Splash when WBC


No splash and no □OK □PASS
18 channel bubbling? Bubbles
contact □NG □FAIL
measurement on filling tube?

19 Counting Splash when RBC


No splash and no □OK □PASS
channel bubbling? Bubbles

Service Manual 139


Appendix

Product Model Serial Number

No. Inspection Item Description Requirement Result Conclusion

measurement on filling tube? contact □NG □FAIL

Counting WBC bath can be


□OK □PASS
20 channel drained correctly or Drained correctly
□NG □FAIL
measurement not

Counting RBC bath can be


□OK □PASS
21 channel drained correctly or Drained correctly
□NG □FAIL
measurement not

Counting
□OK □PASS
22 channel WBC bath wall No residue
□NG □FAIL
measurement

Counting
□OK □PASS
23 channel RBC bath wall No residue
□NG □FAIL
measurement

Counting Counting pool


□OK □PASS
24 channel shield box Screws tightened
□NG □FAIL
measurement installation

Counting Sample probe


Sample probe □OK □PASS
25 channel moves with no
movement □NG □FAIL
measurement interference

Sample probe tube


Counting
does not interfere □OK □PASS
26 channel Sample probe tube
with other □NG □FAIL
measurement
structures

Perform
Refer to the □OK □PASS
27 Maintenance maintenance and
Operation Manual □NG □FAIL
cleaning

Counting pool
voltage RBC aperture □PASS
28 [16, 21]V
measurement voltage □FAIL
and setup

Analyzer status □PASS


29 RBC ≤0.02×1012/L
verification - □FAIL

140 Service Manual


Appendix

Product Model Serial Number

No. Inspection Item Description Requirement Result Conclusion

count

Analyzer status
□PASS
30 verification - HGB ≤1g/L
□FAIL
count

Analyzer status
□PASS
31 verification - HCT ≤0.5%
□FAIL
count

Analyzer status
□PASS
32 verification - PLT ≤10×109/L
□FAIL
count

□PASS
33 Background test WBC ≤0.2×109/L
□FAIL

□PASS
34 Background test RBC ≤0.02×1012/L
□FAIL

□PASS
35 Background test HGB ≤1g/L
□FAIL

□PASS
36 Background test HCT ≤0.5%
□FAIL

□PASS
37 Background test PLT ≤10×109/L
□FAIL

□PASS
38 Impedance gain RBC N/A: Not applicable
□FAIL

□PASS
39 HGB gain HGB N/A: Not applicable
□FAIL

No fault or alarm □OK □PASS


40 Shutdown Shutdown process
occurs □NG □FAIL

Service Manual 141


Add:4-10F, Building 3, Geya Technology Park, Guangming District,
518106, Shenzhen, China
Web:www.genrui-bio.com

P0 1 . 9 1 . 7 0 0 0 6 5 - 0 1

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