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CONTENTS
CONTENTS ...................................................................................................... I
Copyright and Declaration ............................................................................. I
Chapter 1 System Description ..................................................................... 1
1.1 Front View.................................................................................................................... 1
1.2 Side View ..................................................................................................................... 2
1.3 Principles of Operation .............................................................................................. 2
1.3.1 Electrical Impedance Method ....................................................................... 3
1.3.2 WBCs Counting Principles ............................................................................ 3
1.4 WBC Test Principle and Differential ......................................................................... 4
1.5 RBC Test Principles ................................................................................................... 5
1.5.1 RBC Total Number Test Principle ................................................................. 5
1.5.2 Test Principles of RBC Indexes .................................................................... 5
1.6 Platelet Test Principle................................................................................................. 6
1.7 HGB Colorimetric Method ......................................................................................... 6
1.8 Parameters .................................................................................................................. 7

Chapter 2 Notice ........................................................................................... 8


2.1 External Factors.......................................................................................................... 8
2.1.1 Voltage ............................................................................................................. 8
2.1.2 Electromagnetic Interference ........................................................................ 8
2.1.3 Temperature .................................................................................................... 8
2.2 Location Requirement................................................................................................ 8
2.3 Notices for Startup ...................................................................................................... 9
2.4 Blood Samples Collection and Test ......................................................................... 9

Chapter 3 Circuit ......................................................................................... 10


3.1 Introduction ................................................................................................................ 11
3.1.1 Electrical System .......................................................................................... 11
3.1.2 Switched Mode Power Supply (SMPS) ..................................................... 12
3.1.3 ARM-FPGA Board ........................................................................................ 12
3.1.4 Analog Amplifier Board ................................................................................ 13
3.1.5 Valves and Motors Drive Board .................................................................. 14
3.1.6 AVDD Board .................................................................................................. 15
3.1.7 LED Board ..................................................................................................... 16
3.1.8 Recorder ........................................................................................................ 16
3.2 Electrical System Fault ............................................................................................ 17
3.3 Parameters Detection Principle .............................................................................. 19

Chapter 4 Flow System .............................................................................. 20


4.1 Dilutor ......................................................................................................................... 21
4.2 Sample Cup ............................................................................................................... 22

I
CONTENTS

4.3 Vacuum Pump ........................................................................................................... 24


4.4 Sampling Mechanism............................................................................................... 24
4.5 Solenoid Valve .......................................................................................................... 25
4.6 Rolling Pump ............................................................................................................. 25
4.7 Vacuum Chamber ..................................................................................................... 25
4.8 JWLM Board.............................................................................................................. 26
4.9 Function of Flow System Valves ............................................................................ 27
4.10 Flow System Fault .................................................................................................... 28

Chapter 5 Test ............................................................................................. 31


5.1 System Calibration ................................................................................................... 31
5.2 Gain Adjustment ....................................................................................................... 34
5.2.1 WBC, RBC Gain Adjustment ...................................................................... 34
5.2.2 HGB Voltage Adjustment ............................................................................. 34
5.2.3 PLT Gain Adjustment ................................................................................... 35
5.2.4 Vacuum Adjustment...................................................................................... 35
5.3 System Check ........................................................................................................... 35
5.3.1 Motor Check .................................................................................................. 35
5.3.2 Valve Check................................................................................................... 36
5.3.3 System Status Check ................................................................................... 37
5.4 Internal Calibration ................................................................................................... 38

Chapter 6 Software Upgrade and Online .................................................. 39


6.1 ARM Board Software Upgrade ............................................................................... 39
6.1.1 Preparations .................................................................................................. 39
6.1.2 Upgrade Process .......................................................................................... 39
6.2 Online ......................................................................................................................... 40
6.2.1 Preparations before Online ......................................................................... 40
6.2.2 Online Procedures ........................................................................................ 40

Chapter 7 Common Faults ......................................................................... 41


Appendix: Flow System .............................................................................. 43

II
Copyright and Declaration
We owns the copyright of this unpublicized issued manual, and has right to
handle as secret information. This manual just used as reference for operation,
maintenance and service of our product. Other personnel has no right to
publish this manual.
This manual includes special information protected by copyright law. Copyright
reserved, prohibit copy and transmit any content of this manual against not
through written agreement by us.
We don’t make any formally guarantee for this manual, including (but not limit
to) implied guarantee responsibility on marketability and propriety lodged for
certain purpose. We without responsibility for the error included in this manual
and indirectly & abiogenetic damage that is caused by actual representation &
usage provided by this manual.
Content in the manual can be changed without giving notice.
Our obligation:
We only responsible for instrument security, reliability and capability under
following condition:
 Performed assemble, extend, re-debugging, improve and repair by our
authorized personnel;
 Relevant wiring equipment accord with national standard;
 Use the analyzer according to this service manual.
NOTE:
This analyzer cannot be used in family.
WARNING:
If each hospital or institution that is responsible for using this instrument cannot
realize a set of satisfactory service procedure, will cause deviant invalidation of
instrument, even jeopardize to health of human body.
Nowadays, We will provide relevant technical information conditionally when
customer request. In addition, narrate calibration method and other information
through list to help eligible technician to repair our instrument.

I
Copyright

Guarantee
Manufacturer techniques and material
We guarantees automated hematology analyzer no techniques and material
problem within one year from shipping day if under normal use and
maintenance.
Free service
Our obligation under this guarantee not include freight and other fare, not
responsible for direct, indirect and ultimate damage & delay caused by
following condition: improper use, replaced accessories or repaired by
personnel not authorized by us.
This guarantee is not applicable for following items: instrument which is not
through maintenance or already broken; We original nameplate or is replaced
or tore off; our other product.
Security, reliability and run status
If following conditions occur, We are not responsible for the security, reliability
and run status of the analyzer:
 Disassembly, stretch and re-debugging;
 Serviced or changed not by our authorized personnel .

Send back instrument


If it’s needed to send back the instrument, please contact with distributor to get
detailed information, inform the analyzer serial number which marked on
nameplate, we will not accept if S/N cannot be identified. Please mark
instrument No. and S/N, briefly state the reason on sending back instrument.
Freight: if send back instrument for service, purchaser bears the freight
(including custom fare)

Version: 2020/02

II
Chapter 1 System Description

1.1 Front View


Display is a 10.4-inch LCD with a resolution of 800 × 600.

Figure 1-1

1
System Description

1.2 Side View

Figure 1-2

1.3 Principles of Operation


Automated Hematology Analyzer is a multi-parameter, It can display 21
parameters and 3 histograms. Analyzer adopts electrical impedance method
for WBC, RBC and PLT test and colorimetric method for HGB test.

2
System Description

1.3.1 Electrical Impedance Method

Electrical impedance method is based on the non-conductivity of blood cells.


When the blood cells in Diluent pass through the ruby aperture, resistance will
change, base on that we can get the counting and volume of WBCs.

1.3.2 WBCs Counting Principles

Automated Hematology Analyzer uses two channels for counting, which


means WBCs and RBCs are in different counting chambers. Quantitative
blood is diluted by quantitative dilution,and then RBCs are dissolved by Lyse
so as to run WBCs counting.

Figure 1-3
Inner and outer electrodes of constant current source are located in front
chamber and back chamber respectively. There is a ruby aperture with a
diameter of 100μm between these two chambers. Back chamber is full of a
certain concentration of cell suspension, and front chamber is filled with
Diluent.
Conductivity of cells is lower than that of Diluent. They are being treated as
relatively poor conductors. When a cell particle goes through the ruby aperture,
it will cause an instantaneous pulse voltage between inner and outer
electrodes. Number of pulses generated is indicative of number of particles

3
System Description

that traversed aperture. Amplitude of each pulse is in proportion to the volume


of particle that produced it. Under the effect of negative pressure, a certain
volume of cells will constantly go through ruby aperture to produce a series of
pulses.
Total number of a certain volume of cells can be obtained by pulse
amplification, identification, deformation, threshold adjustment and A/D
conversion.

1.4 WBC Test Principle and Differential


Along with WBC parameters, analyzer could also give the WBC histogram
which can display the average volume of specific cells population, cells
distribution and abnormal cells.
Add a certain amount of dilution and Lyse into WBC sample cup. Lyse can
make RBC dissolved and WBC dehydrated to form "film covers core", so that
the processed WBC volume is between 35 fL and 45 fL. In the measurement of
WBC, analyzer divides distribution range of WBC volume (35~350 fL) into 256
channels. Each channel is 1.36 fL. Pulse of each WBC is saved in
corresponding channel according to its volume and then being processed by a
computer to compose a smooth curve so as to get a WBC volume distribution
histogram (See Figure 1-4). The ordinate indicates the relative quantity of
WBC (rel.no) and the abscissa indicates the volume of WBC (fL).

Figure 1-4
According to the volume, WBCs handled by Lyse can be subdivided into three
categories: Lymphocyte (LYM), Monocyte (MID) and Granulocyte (GRAN).

4
System Description

LYM 35—90 fL
MID 90—160 fL (Composed of eosinophils, basophils and monocytes.)
GRAN 160~350 fL

1.5 RBC Test Principles

1.5.1 RBC Total Number Test Principle

RBC test principle is alike to WBC test principle. In sample cup which is similar
to that of WBC, with the effect of negative pressure, a certain amount of cells
go through ruby aperture (68μm) and produce corresponding pulse in size.
Analyzer can work out total number and average volume of RBC according to
the size and height of pulse. Meanwhile, it can also get a RBC volume
distribution histogram (See Figure 1-5) according to single measured RBC
volume and the percentage of cells which have the same volume.

Figure 1-5
Under normal conditions, we can ignore WBCs due to the proportion between
RBCs and WBCs is 750:1.However, under certain special conditions, such as
leukemia with morbid blood will result in abnormal RBC counting.

1.5.2 Test Principles of RBC Indexes

HCT can be worked out by dividing the product of MCV and RBC by 10.
According to relative algorithm, analyzer can get MCH, MCHC though RBC,
MCV and HGB. Red Cell Distribution Width (RDW) can be figured out by
detecting RBC number and the difference of RBC size so as to reflect the
heterogeneity of RBC volume. RDW can reflect the degree of RBC size
difference and has clinical significance of anemia diagnosis.

5
System Description

1.6 Platelet Test Principle


Platelet (PLT) and RBC are being tested in the same sample cup. The
instrument will count platelet and RBC respectively according to different
threshold (Figure 1-6). Data of platelet are being saved in 64 channels in 2~30
fL interval.

Figure 1-6
PDW can be worked out though histogram. MPV is the arithmetic mean
volume of platelets which are shown by the curve in histogram. MPV of normal
people has a nonlinear negative correlation with platelet number. PCT is got
from MPV and PLT.

1.7 HGB Colorimetric Method


Automated Hematology Analyzer adopts photoelectric colorimetry to measure
and calculate HGB. Add Lyse into the diluted sample, RBC will be dissolved
and hemoglobin will be released. Then hemoglobin combines with Lyse to form
cyanohemoglobin. Measure the transmission light intensity of this compound in
sample cup through the monochromatic light with a wavelength of 540nm and
then compare it with the result in blank state to get the hemoglobin
concentration (blank state refers to the state that only has Diluent in sample
cup). Instruments can test automatically, then calculate and print out the result
(in g/L).
E 
HGB  K   B  ;
 ES 
K is a constant.
EB is the luminous intensity of light passed through Diluent.
ES is the luminous intensity of light passed through sample.

6
System Description

1.8 Parameters
Automated Hematology Analyzer generates following 21 hematologic
measurements with EDTA-anticoagulated human blood:

Table 1-1 21 Parameters


Normal
Abbreviation Full Name Unit
range
WBC White Blood Cell Count 4.0-10.0 109cells/L
LYM% Lymphocyte Percent 20.0-40.0 %
MID% Monocyte Percent 1.0-15.0 %
GRAN% Granulocyte Percent 50.0-70.0 %
LYM# Lymphocyte Count 0.6-4.1 9
10 cells/L
MID# Monocyte Count 0.1-1.8 109cells/L
GRAN# Granulocyte Count 2.0-7.8 109cells/L
RBC Red Blood Cell Count 3.50-5.50 1012cells/L
HGB Hemoglobin Concentration 110-150 g/L(or g/dL)
Hematocrit (Relative Volume of
HCT 36.0-48.0 %
Erythrocytes)
MCV Mean Corpuscular Volume 80.0-99.0 fL
MCH Mean Corpuscular Hemoglobin 26.0-32.0 pg
Mean Corpuscular Hemoglobin
MCHC 320-360 g/L(or g/dL)
Concentration
Red Blood Cell Distribution Width
RDW_CV 11.5-14.5 %
Repeat Precision
Red Blood Cell Distribution Width
RDW_SD 39.0-46.0 fL
StDev
PLT Platelet Count 100-300 109cells/L
MPV Mean Platelet Volume 7.4-10.4 fL
PDW Platelet Distribution Width 10.0-14.0 fL
PCT Plateletcrit 0.10-0.28 %
P_LCR Large Platelet Ratio 13-43 %
P_LCC Large Platelet 13-129 9
10 cells/L

7
Chapter 2 Notice

2.1 External Factors

2.1.1 Voltage

To ensure normal working and stability of data test, analyzer should equipped
with 220V power supply. If the voltage is unstable, high-precision automated
AC voltage-stabilized power source is needed. If intermittent power-down often
happens, UPS uninterruptible power supply needs to be installed to ensure the
good performance of power supply and circuit board.

2.1.2 Electromagnetic Interference

Because the signals gathered by analyzer are very weak, external interference
may result in abnormal data on test results. It is recommended that analyzer
should be connected with grounding wire to make interference signals into the
earth from the grounding wire so as to avoid electromagnetic impact. Analyzer
should be kept from interference equipment, such as monitors, copiers,
centrifuges and x-ray equipment etc..

2.1.3 Temperature

Analyzer working temperature is 15℃ to 35℃. Low temperature will affect


reagents and cause test error. The most common thing is that the value of
WBC and HGB are too high, because the dissolving speed of Lyse is slow with
low temperature. The value of PLT is on the low side, since platelets aggregate
with low temperature.

2.2 Location Requirement


1. Analyzer and reagents should be on the same level to ensure that the
reagents could be quickly injected to the analyzer.
2. Waste container should be placed on the ground, and not on the same
level with the analyzer. (Avoid Waste contamination)

8
Notice

3. Connect reagents connectors correctly according to color. Blue is for


Diluent, red for Lyse .

2.3 Notices for Startup


1. Check tubes connectors after the power supply and reagents are
connected well. If there are problems, solve them before startup.
2. Check whether there are abnormal smell, sound and picture. If there are
problems, power off and check.
3. Check whether the picture displayed and program initialization are normal.
If there is no abnormality, analyzer will enter Main Screen.

2.4 Blood Samples Collection and Test


Test modes are divided into Whole Blood Mode and Pre-diluent Mode.
1. Whole blood collection: Collect the venous blood by vacutainer.
Anticoagulant in vacutainer can anticoagulate blood.
2. Pre-diluent collection: Collect peripheral blood with micro blood collection
tube. Such as finger and ear etc..
3. Whole Blood Mode test: Place the anticoagulant tube with blood sample
under the sample aspiration probe, then press “RUN” for counting.
Pre-diluent Mode test: Drain Diluent into the sample tube through probe
and then inject 20μL peripheral blood into it for mixing. Place the tube
under the probe and then press “RUN” for counting.

NOTE: When collect peripheral blood, avoid squeezing out the tissue fluid with
excessive force to affect PLT counting. Likewise, overexertion will make
platelets aggregate and cause PLT counting error. Therefore, relatively deep
puncture is needed for peripheral blood collection. Wipe out the first drop of
blood, and then collect blood sample.

9
Chapter 3 Circuit

The circuit system is composed of switched-mode power supply (SMPS),


ARM-FPGA board,Valves and Motors drive board, Analog amplifier board,
AVDD board, thermal printer (recorder),LED board and JWLM board. See
Figure 3-1

Valve and
Motor Drive
Board,
JWLM
Board

ARM-FPGA Board
SMPS LED
Board

Analog AVDD
Thermal
Amplifier Board
Printer
Board (DC/DC)

WBC & RBC Sample cup,


Temperature Sensor

Figure 3-1

10
Circuit

3.1 Introduction

3.1.1 Electrical System

Valve and Motor ARM-FPGA Board


Drive Board

AVDD
Board

Analog
Amplifier Board

Figure 3-2 Rear Panel

11
Circuit

Recorder Board

Switched Mode Power Supply

Figure 3-3 Switched Mode Power Supply and Recorder

3.1.2 Switched Mode Power Supply (SMPS)

Provide a stable DC power supply for analyzer, there is a triple power supply:
24V, 12V, 5V. Their functions are as follows:
24V Power Supply: Provides power for motor.
12V Power Supply: Provides power for valve drive, thermal printer and
AVDD Board.
5V Power Supply: Provides power for ARM-FPGA board, print server
board and thermal printer.

3.1.3 ARM-FPGA Board

ARM-FPGA board is the control center of analyzer. The software is based on


Linux, which is responsible for data processing, print server and Valves &
Motors Drive board control.

12
Circuit

TF Card Slot

USB
Port

Battery

Figure 3-4 ARM-FPGA Board

3.1.4 Analog Amplifier Board

Analog amplifier board is used for weak signal amplification and processing,
then adjusts it to be the right signal to the FPGA board for data conversion.
Meanwhile, it also amplifies the signals of parameters, such as pressure,
temperature and HGB signal etc.

13
Circuit

Pressure
Sensor

WBC Connector

HGB Connector
RBC Connector

Figure 3-5 Analog Amplifier Board

3.1.5 Valves and Motors Drive Board

Valves and motors drive board is the executive circuit unit for solenoid valves
and step motors.

14
Circuit

Figure 3-6 Valves and Motors Drive Board

3.1.6 AVDD Board

AVDD board is the secondary power supply, which provides 12V power to
switched-mode power supply for conversion and lower noise and stable power
supply for analog board. Output voltage is +12V、-12V and 100V. The quality of
AVDD board is very important to cell signals. If it is damaged, analyzer can not
work normally.

15
Circuit

Figure 3-7 AVDD Board

3.1.7 LED Board

LED board is for Status Indicators on front panel.

Buzzer

Figure 3-8 Button Board

3.1.8 Recorder

Recorder uses thermal paper for printing. Thermal surface of the thermal paper
should face up. If the direction is wrong, recorder cannot work.

16
Circuit

Figure 3-9 Recorder

3.2 Electrical System Fault


Phenomenon:
Screen goes black after startup, indicators do not work and analyzer has no
reaction.
Troubleshooting:
1. This may result from the circuit protection of SMPS due to the voltage or
current overshoot during startup. Turn off the analyzer and restart it after
30 seconds
2. SMPS does not work, check whether the fuse has burned off. If so, replace
it; if not, replace SMPS.

Phenomenon:
Screen goes black or white after startup. Analyzer has no action, but power
indicator works normally.
Troubleshooting: It is probably because the ARM-FPGA board cannot work
normally. Restart the analyzer. If it still cannot work, replace ARM-FPGA board
since it may be damaged.

Phenomenon: Valves and motors work abnormally.


Troubleshooting: Turn off the power supply. Replace ARM-FPGA board due
to the damage of FPGA chip.

17
Circuit

Phenomenon: All test results are 0, but counting time is normal.


Troubleshooting: Open the sample shielding case, check whether the sample
in WBC sample cup is blood-red obviously when sampling, if not, it indicates
no sample. At this moment, check whether there are problems with flow
system, micro-sampler and MA motor.

Phenomenon:
Results of WBC, RBC and PLT are 0, but HGB value and counting time are
normal.
Troubleshooting: Constant current source is damaged or no output from
AVDD board 100V Power supply. Replace constant current source or AVDD
board.

Phenomenon: All parameters, counting vacuum and time are abnormal.


Troubleshooting: AVDD board ±12V power supply has no output. Open the
shielding case of AVDD board and check whether the ±12V power supply
indicator is normal, if not, replace AVDD board.

Phenomenon: Time cannot be saved.


Troubleshooting: Button battery on the ARM-FPGA board has no power,
please replace it.

18
Circuit

3.3 Parameters Detection Principle

Pulse Number PLT Number


2~30fl PCT
MPV

Pulse Size PDW


Produce Large
RBC/PLT Channel and Small Pulse
RDW

Pulse Size
MCV
Second Dilution
>30fl HCT
Sample RBC
Pulse Number
Aspiration
Probe Dilution
MCH

Transforming Agent
Blood Sample Release
HGB HGB MCHC
HiCN

Lyse
WBC/HGB Channel
Pulse Number
WBC Initial Cell
Pulse Young Cell
35~90fl LYM
Number MON
90~160fl MID
Pulse Size EOS
160~350fl GRAN
BASO

Figure 3-10

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Chapter 4 Flow System

Figure 4-1 shows the whole framework of flow system behind right side door.

Sampling Three-way Valve Two-way Valve


mechanism

JWLM Board

Sample Cup

Vacuum Pump

Figure 4-1(1)

20
Flow System

Vacuum Chamber Preheating bath

Figure 4-1(2)

4.1 Dilutor
Dilutor is used for counting, rinse, prime and blood dilution at startup. It also
provides Diluent and power for cleaning flow system. Circuit board provides
DC24V to motor.
Dilutor consists of small syringe, Lyse syringe, Diluent syringe, motor, seal ring

21
Flow System

etc.Syringes can be dismantled separately and they allows operator to


exchange the whole syringe or seal ring conveniently.
Installation of dilutor motor differs from that of other motors. Motor is above the
syringe to avoid being corroded or damaged by syringe leakage.
Lyse syringe and Diluent syringe are controlled by the same motor. And the
small syringe is by a separate one. See Figure 4-2.

Lyse Syringe Diluent Syringe Small Syringe

Figure 4-2 Dilutor

4.2 Sample Cup

Sample cup is the sensor part of counting. It is the forefront detecting unit of

22
Flow System

data collection.
Functionally, it consists of inner and outer electrode, front and back chamber,
ruby aperture etc..
Analyzer adopts Coulter Principle (Electrical Impedance Method) for WBC,
RBC and PLT counting. When testing, circuit will provide constant current for
sample cup through dilute conductive liquid. Loop resistance will change if
cells pass through ruby aperture. Cells in different size will produce different
electric pulse amplitudes, so that cells quantity and volume could be
calculated.
As for HGB counting, Automated Hematology Analyzer could analyze cells by
making colorimetric analysis on blood sample with Lyse through lighting and
receiving part of WBC cup.

Add Diluent
Add
Diluent

Add Lyse

Figure 4-3 Sample Cup

23
Flow System

4.3 Vacuum Pump


Vacuum pump is the power unit for creating negative pressure. Its working
voltage is DC12V. Fluid section connector has one air outlet and one air inlet.
When working, vacuum pump is driving the suction film by internal rotary motor
to make air in from inlet and out from outlet. (the influent liquid in the course of
counting will also be exhausted by vacuum pump)

Figure 4-4 Vacuum Pump

4.4 Sampling Mechanism


Sampling mechanism controls the probe for sampling, dilution and rinse etc.

Timing Belt

Probe

Cleaning Cover
Leader

Figure 4-5

24
Flow System

4.5 Solenoid Valve


Valve is important component of flow system. Various valves are connected
with tubes to form the whole flow system and controlling the liquid flow
direction. Its working voltage is DC12V.

3-way Valve 2-way Valve


(3 Connectors) (2 Connectors)

Figure 4-6

4.6 Rolling Pump


Rolling pump with DC12V is for mixing blood sample in sample cup by bubbles
and provides recoiling force for flushing.

Figure 4-7 Rolling Pump

4.7 Vacuum Chamber


Vacuum chamber is a column container made of plastic encapsulated by
epoxy resin. It provides negative pressure for flow system under the force of

25
Flow System

vacuum pump.
There are two connectors on the upper of vacuum chamber: one is connected
to pressure sensor of control board which detects negative pressure of
vacuum chamber (specified value is 78kpa±2). If the negative pressure is not
within this range, control board will provide drive voltage for vacuum pump to
start working until the pressure reaches the specified value; the other one is
connected to related fluid sections for WBC,RBC counting and rinse.
There is an outlet at the end of vacuum chamber. It is for exhausting air and
liquid in vacuum chamber into Waste container.

Figure 4-8 Vacuum Chamber

4.8 JWLM Board


JWLM board is for detecting the liquid level of Diluent and Lyse in glass tube.
Connect electrical system and flow system before use. Switch on the power
and check whether the voltage of “VCC” is 5V without connecting with Diluent
and Lyse. If the voltage is normal, detect the voltage of UP” ,“DOWN”,”EZ” and
“HEM”.
The grounding voltage of “UP” ,“DOWN”,”EZ” and “HEM” should be 2.9±0.1V
when there is no liquid in tubes. If not, adjust rheostats W1,W2,W3,and W4,
until the voltage of “UP” ,“DOWN”,”EZ” and “HEM” reaches 2.9±0.1V.

26
Flow System

Figure 4-9 JWLM Board

4.9 Function of Flow System Valves


NO Function Remark(Valve Control Content)
V1 Flush and mix Mix sample and drain liquid
Clean the outwall of probe and add reagent into
V2 Drain fluid
sample cup
V3 Prime Lyse Aspirate and drain Lyse
V4 Dilutor aspiration Aspirate and drain Diluent
V5 Sampling and dilution Collect and Dilute blood sample
V6 Control Diluent addition Control Diluent addition of WBC, RBC cup
Clean the outwall of probe and add Clean Rear
V7 Drain fluid
Chamber
V8 Flush and mix Mix sample and drain liquid

27
Flow System

V9 Counting Prime, counting


V10 Probe Cleaning Clean the outwall of probe

4.10 Flow System Fault


Phenomenon: abnormal sound of sampling mechanism
Troubleshooting:
1. Lubrication of motor leader is poor. Apply grease to the leader. DO NOT
use liquid lubricating oil.
2. Position switch fault causes motor cannot stop working normally and
comes out abnormal sound. Check whether the switch is well connected
and whether the circuit is on by AVO meter.
3. Connection between motor and ARM-FPGA board is poor.
4. Motor is corroded by liquid and its internal units get stuck. Disconnect the
motor and clean its internal crystals.

Phenomenon: Sample cup overflow.


Troubleshooting:
1. Vacuum pump does not work, or the valve under the sample cup is
unopened or opened improperly. Please replace vacuum pump or valve.
2. There are foreign bodies at the bottom of sample cup or the valve under
the sample cup. Please clean up foreign bodies.
3. If the valves do not work, change corresponding valves connectors with
those of other valves, and then test them again. If there is no problem with
valve, there may be something wrong with the drive part of the circuit
board.

Phenomenon: WBC/RBC clogs.


Troubleshooting:
1. Rinse and prime WBC/RBC cups with probe Detergent or remove the ruby
for cleaning.
2. If the test time is long, it indicates the ruby aperture has slight clog. Please
cauterize, rinse and prime it with probe Detergent.

Phenomenon: Sample aspiration probe leakage


Troubleshooting:
1. Replace cleaning cover;
2. The connector connected with sample aspiration probe has air leakage;

28
Flow System

3. Small syringe air leakage.

Phenomenon: High PLT background value


Troubleshooting:
1. The sample cup is dirty. Clean sample cup or prime it with probe Detergent
for 5 to 10 minutes, and then clean it again.
2. Reagent is contaminated. Please replace reagent;
3. Keep analyzer away from the instruments which are with strong magnetic
field and vibration. Analyzer also needs to be connected with grounding
wire.
4. Reagent crystallization result from cold weather. Analyzer consider the
pulse of crystalline particles as the pulse of the PLT. Reagents should be
heated up.

Phenomenon: High PLT value


Troubleshooting:
1. There is blood left on sample aspiration probe inwall or the sample cup is
dirty. Please replace sample aspiration probe or run "Rinse Fluidics"
program.
2. Keep analyzer away from the instruments which are with strong
interference. Analyzer also needs to be connected with grounding wire.
3. Adjust results through QC calibration, if there is deviation.

Phenomenon: RBC/PLT is too low in Pre-diluent Mode.


Troubleshooting:
1. Small motor of dilutor cannot work normally. Check whether the motor is
corroded. Please replace it if it is.
2. Check whether the small syringe has leakage or air leakage. Please
replace it if it is.
3. Small motor cannot work results from the problems of its circuit drive.

Phenomenon: All test results are too low in Whole Blood Mode.
Troubleshooting:
1. Sample in small syringe is not enough or the small syringes has air leakage.
Please replace the syringe.
2. Tube connector between sample aspiration probe and small syringe has air
leakage. Please check tubes.

29
Flow System

3. Motor of small syringe cannot run normally.

Phenomenon: WBC/HGB is too high, "***" appears.


Troubleshooting:
1. Lyse is not enough, please check.
2. Lyse cannot dissolve blood cells well due to the low temperature. Please
operate within receptacle temperature range.
3. Lyse is not enough due to tube air leakage. Please check Lyse tube.
4. Rolling pump cannot work and mix sample, or the intensity of rolling pump
is weak. Please replace rolling pump.

Phenomenon: HGB is too low.


Troubleshooting:
1. Check whether HGB background voltage changes frequently.
2. Whether WBC cup indicator is dark or not on. Please replace indicator or
WBC cup.
Phenomenon: probe does not sample in Pre-diluent Mode
Troubleshooting:
1. Diluent syringe does not work. Friction of leader is too large, please apply
grease to it.
2. Loose tube leads to air leakage or tube is disconnected from connector.
3. Seal ring of Diluent syringe is leaky, please change another one.

Phenomenon: probe does not drain


Troubleshooting:
1. Diluent syringe does not work. Friction of leader is too large, please apply
grease to it.
2. Loose tube leads to air leakage or tube is disconnected from connector.
3. Seal ring of Diluent syringe is leaky, please change another one.

30
Chapter 5 Test

5.1 System Calibration


Click ”Setup”— “Service”, input code ”1999” and click “OK” to enter Motor
parameters screen, See Figure 5-1.

Figure 5-1 Motor parameters

Operator can test motors, set motor steps and WBC, RBC test time etc. in
System Calibration screen. Only the Items in Table 5-1 are those need to be
calibrated. Please refer to Table 5-1 for details.

31
Test

Table 5-1

Reference Value Remark


Item Function Volume
Step
(mL)
Lyse consumption in Whole Blood
Mode
MA1 850 0.60±0.03
*subject to current technology
quantity
Lyse consumption in Pre-diluent
MA2 708 0.50±0.03
Mode
MA3 Probe Detergent consumption 159 0.8±0.1
Diluent consumption of WBC cup
MA4 538 2.7±0.2
in Whole Blood Mode
Diluent consumption of RBC cup
MA5 358 1.8±0.2
in Whole Blood Mode
Diluent consumption of WBC cup
MA6 338 1.7±0.2
in Pre-diluent Mode
Diluent consumption of RBC cup
MA7 338 1.7±0.2
in Pre-diluent Mode
Aspiration volume of mixture of
Diluent and blood sample in
The volume of
MA8 Pre-diluent Mode 70 0.34-0.38
Diluent should
*subject to current technology
be enough for 2
quantity
test and the
Diuent consumption for mixing
remain should
blood sample in Pre-diluent Mode
MA9 159 0.78-0.86 be 0.1mL
*subject to current technology
quantity

First aspiration volume of blood


sample from test tube
MB1 13uL
*subject to current technology
quantity

Second aspiration volume of blood


sample from WBC cup
MB2 25.6uL
*subject to current technology
quantity

Probe should aims at the


MC1 Probe position at WBC cup
centre of WBC cup
Probe should aims at the
MC2 Probe position at RBC cup
centre of RBC cup

32
Test

Reference Value Remark


Item Function Volume
Step
(mL)
Probe should stretch into
Probe sampling position at WBC WBC cup and higher than
MD1
cup WBC cup platform, but is
not higher than 1mm.

The interval between


sampling arm and
MD2 Probe standby position cleaning cover is 3~5mm.
Probe takes in cleaning
cover for 1mm.

33
Test

5.2 Gain Adjustment


Input “1999” and click “Next page” on bottom to enter the screen shown as
below.

Figure 5-2 Gain reference

5.2.1 WBC, RBC Gain Adjustment

Test with control and check the gain of WBC and RBC. Adjustment is not
necessary if it is within the acceptable range. If not, input current gain value in
Current WBC gain box, then input the gain value of control in Expected WBC
gain box, click "WBC Gain" button to adjust the gain. Operation of RBC gain
adjustment is basically the same. When finished, click “OK” on bottom to save
it. Test with control again to check whether the gain has been corrected.

5.2.2 HGB Voltage Adjustment

HGB_BACK is about 4V. Adjust the voltage as following: correct the value in
HGB Gain box, and click “OK” on bottom.Click “HGB Blank voltage”,
Meanwhile the voltage shown in HGB Blank voltage box will change too. The
larger the channel gain is, the lower the voltage will be, and vice versa.

34
Test

HGB_ZERO do not need to be adjusted. Generally it is 0.00 or 0.02.

5.2.3 PLT Gain Adjustment

Gain of PLT is corrected by inputting value in PLT Gain box. Click “OK” on
bottom for saving. The larger the channel gain is, the lower the PLT gain will be,
and vice versa.
NOTICE: PLT gain has been adjusted strictly before delivery. Generally it
does not need to be corrected.

5.2.4 Vacuum Adjustment

Input value in Vacuum adjustment box and click “Vacuum adjustment” button.
Vacuum pump will start pumping. When finished, vacuum value will be shown
in Vaccum box.
NOTICE: Vacuum has been tested strictly before delivery. Generally it
does not need to be adjusted.

5.3 System Check

5.3.1 Motor Check

At Motor Check screen, operator can check if motors are in normal condition.
Click the item wanted to check, then the result will be shown. Click “Return” to
return to Main screen. See Figure 5-3.

35
Test

Figure 5-3 Motor detection

Press “Setup”—“Service”, input the code “2006” to enter Motor Check screen.
Operator could test MA, MC,MD motors and P1, P2. P1 is for vacuum and P2
is for rolling pump. Click corresponding test item button to check its condition.
This operation is only for test, operator could not correct the motor steps here.

5.3.2 Valve Check

Click “Next page” on bottom of Motor detection screen to enter corresponding


screen as Figure 5-4 shows.

36
Test

Figure 5-4 Valve detection


Analyzer has 18 valves. Click corresponding valve item to check whether it is
in normal condition. If so, operator could hear the action sound of
corresponding valve; if not, operator should exchange the connector of test
valve with that of other valves and test the faulted valve through other drive
circuit. If the valve still does not work, itself is damaged; If not, the problem
might be caused by drive circuit.
This method is also applicable to P1,P2 test.

5.3.3 System Status Check

Click “Next page” on top bottom of System Check screen to enter


corresponding screen as Figure 5-5 shows.
System Status detection screen presents current status information like
temperature, voltage of constant current source, 5V voltage, HGB_ZERO,
HGB_BACK, WBC voltage and RBC voltage etc.. Click WBC still voltage
button, analyzer will start working and display corresponding voltage.
Operator could not correct parameter value in this screen. Value displayed is
only the reference for troubleshooting.

37
Test

Figure 5-5 System State detection

5.4 Internal Calibration

Click “Setup”—“Service” and input the code “2008” to enter Internal Calibration
screen. Operation of internal calibration is similar to that of external.
Internal calibration is for our internal use. External calibration is appropriate for
users. Both are equally effective.

38
Chapter 6 Software Upgrade and Online

6.1 ARM Board Software Upgrade

6.1.1 Preparations

1. An U disk
2. Application program

6.1.2 Upgrade Process

1. Copy the application program into the root directory of U disk. Other
irrelevant files in U disk do not affect upgrade.
2. Plug the U disk into the USB port. See Figure 6-1.
3. Click “Setup”—“Service”, input “9999” in prompt dialog box and then click
“OK”. Analyzer will read the application program automatically for upgrade.
4. Read-write process will last for about 5 seconds. A dialogue box will pop
up to prompt upgrade is successful. Click “OK” and restart the analyzer to
complete upgrade.
5. If analyzer prompts that U disk cannot be recognized, restart and repeat
step 2-4.
6. Unrecognized U disk also can result from damaged USB port or
unsupported U disk. Analyzer may not read some U disks, please replace
U disk.

Figure 6-1 USB Port

39
Software Upgrade and Online

6.2 Online
Analyzer is able to transmit data to computer by connected with computer.
Install online program in computer allows operator to process, save and print
data.

6.2.1 Preparations before Online

1. A serial line for COM port.


Because of the COM ports of rear panel and computer are both male
(DB9), please use the serial line whose terminals are both female (DB9).
And the internal connection of the serial line should be as following picture
shows: (numbers indicate the position of ports)
2 2
3 3
5 5
The rest ports are not necessary to be connected. Serial line whose
terminals are both female and internal connection is just as above picture
shows could be obtained in market.
2. Online program

6.2.2 Online Procedures

1. Connect analyzer with computer through the COM port on rear panel of
analyzer and the computer COM port.
2. Install online program in computer. Generally the software password is null
or just the user name.
3. Set “Auto Trans” on. Hexadecimal and HL7 are available transmission
modes for operator. Ensure that the transmission mode is in accord with
the online software.
4. Computer is able to receive the data from analyzer after each test
automatically. But if “Auto Trans” is off, operator should click “Trans”
manually for data transmission.

40
Chapter 7 Common Faults

Fault Cause
Power switch is ineffective 1. Power line connection fault;
2. Fuse blew out;
3. AC socket fault.
Fluid leakage 1. Pump tube is broken;
2. Filter clog;
3. Pipeline is loose;
4. Damaged solenoid valve leads to
sample cup overflow.
Low vacuum Vacuum doesn’t reach standard value
within set time. It may be caused by:
1. Damaged pressure sensor which
leads to pressure measurement
failure. The reason for this fault is
higher pressure;
2. Air leakage of pipeline.
No Lyse No Lyse or the optocoupler for Lyse
detection is broken.
No Diluent No Diluent or the optocoupler for Diluent
detection is broken.
Motor fault 1. Diluter gets stuck or damaged, and it
leads to over-large motion
resistance;
2. Poor contact of motor signal wire;
3. Poor contact of connecting line
between valve to motor drive board
or FPGA board;
4. Communication between ARM
-FPGA board and Valves & Motors
Drive is abnormal;
5. Positioning switch or optocoupler is
damaged.
Abnormal voltage 1. AVDD board is damaged;
2. ARM-FPGA board cannot collect
misinformation properly;
3. Analog board is damaged.

41
Common Faults

Abnormal background value 1. Diluent, Diluent tube or counting


chamber is polluted. Diluent is
expired;
2. Poor contact of RBC sample cup
electrode;
3. RBC ruby aperture is polluted and
blocked by impurities;
4. Shielding case of sample cup is not
covered completely or it has poor
contact.
5. Analog board RBC signal channel
circuit is damaged.
HGB fault:background voltage is 0 HGB LED light source or relative circuit
is damaged.
HGB fault:background voltage can 1. Loss control of analog board digital
not be adjusted gain;
2. Analog board HGB circuit is
damaged;
3. Connecting line between
ARM-FPGA board and analog board
is loose or FPGA board is out of
control.
HGB fault:high HGB_ZERO 1. If HGB_ZERO is nearly the same as
HGB_BACK,LED light of HGB will
keep lighting. Analyzer is out of
control and cannot run test properly.
2. High HGB_ZERO is caused by
damaged analog board HGB circuit.
Recorder fault 1. Poor contact of communication line
between print board or recorder;
2. Recorder is damaged.
Abnormal temperature 1. Abnormal temperature;
2. Temperature sensor fault.

42
Appendix: Flow System

43

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