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I
CONTENTS
Copyright and Declaration...................................................................................................................I
Chapter 1 System Description..................................................................................................1
1.1 Front View 1
1.2 Rear View 2
1.3 Principles of Operation 3
1.4 WBC Test Principle and Differential 4
1.5 RBC Test Principles 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 Switch Mode Power Supply (SMPS)..........................................................12
3.1.3 ARM Board......................................................................................................12
3.1.4 FPGA Board....................................................................................................13
3.1.5 Analog Amplifier Board..................................................................................13
3.1.6 Valve and Motor Drive Board.......................................................................14
3.1.7 AVDD Board....................................................................................................15
3.1.8 Button Board...................................................................................................15
3.1.9 Reorder............................................................................................................16
3.2 Electrical System Fault 16
3.3 Parameters Detection Principle 18
Chapter 4 Flow System............................................................................................................19
4.1 Dilutor 20
4.2 Sample Cup 21
4.3 Vacuum Pump 22
4.4 Sampling Mechanism 22
4.5 Solenoid Valve 23
4.6 Vacuum Chamber24
I
CONTENTS
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: 2900P-201301
II
Chapter 1 System Description
Display is a 10.4-inch LCD. The 5 shortcut keys are Print, Flush, Mode, Prime
and Drain respectively.
1
System Description
Figure 1-1
Mouse and
Keyboard Port
USB Port
COM Port
Grounding
Waste Terminal
Sensor Diluent Port
Power Switch
Lyse Port
Detergent Port
Waste Port
Figure 1-2
2
System Description
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
3
System Description
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 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 (35~450 fL) into 256
channels. Each channel is 1.64 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).
4
System Description
Figure 1-4
According to the volume, WBCs handled by Lyse can be subdivided into three
categories: Lymphocyte (LYM), Monocyte (MID) and Granulocyte (GRAN).
LYM 35—90 fL
MID 90—160 fL (Composed of eosinophils, basophils and monocytes.)
GRAN 160~450 fL
RBC test principle is alike to WBC test principle. With the effect of negative
pressure, a certain amount of cells go through ruby aperture (80μm) 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.
5
System Description
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.
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.
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
6
System Description
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.
1.8 Parameters
7
System Description
8
Chapter 2 Notice
2.1.1 Voltage
2.1.3 Temperature
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)
3. Connect reagents connectors correctly according to color. Blue is for
Diluent, red for Lyse and yellow for Detergent.
9
Notice
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.
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 sampling probe, then press “RUN” for counting.
4. 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.
NOTICE: 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.
10
Chapter 3 Circuit
Valve and
motor drive
board,
LMS
Board
ARM FPGA AVDD
SMPS Board Board Board
Button (DC/DC)
Board
Thermal Analog
Printer Amplifier
Board
Sample cup,
Temperature Sensor
Figure 3-1
11
Circuit
3.1 Introduction
ARM FPGA
Board Board
Analog
Amplifier
Board
AVDD
Board
SMPS
12
Circuit
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 board, FPGA board and
thermal printer
USB
Port
13
Circuit
FPGA board is used for software logic control and data collection, it provides
parameters for ARM board and executes orders. See the Figure bellow.
Port for Valve and Motor Drive Board "RUN" Key Port
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..
Pressure
Sensor
14
HGB
Connector
Temperature
Sensor Connector Sample Cup Connector
Circuit
Valve and motor drive board is the executive circuit unit for solenoid valves
and step motors.
AVDD board is the secondary power supply, which provides 12V power to
switch mode power supply for conversion and lower noise and stable power
15
Circuit
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
cannot work normally.
Button Board is for the shortcut keys on front panel. If one of the shortcut keys
Buzzer
gets stuck, other shortcut keys cannot be used, and the “RUN” Key is out of
order.
16
Circuit
3.1.9 Reorder
Recorder uses thermal paper for printing. Thermal surface of the thermal
paper should face up. If the direction is wrong, recorder cannot work.
Phenomenon:
Screen goes black after startup, indicators do not work and analyzer has no
reaction.
17
Circuit
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 board cannot work
normally. Restart the analyzer. If it still cannot work, replace ARM board since
it may be damaged.
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.
18
Circuit
19
Chapter 4 Flow System
Figure 4-1 shows the whole framework of flow system behind right side door.
Vacuum
Sample Cup Vacuum Pump LMS Board
Chamber
Figure 4-1
20
Flow System
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 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.
21
Flow System
Sample cup is the sensor part of counting. It is the forefront detecting unit of
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 sample cup.
Sample Cup
Run Key
Isolation Cup
22
Flow System
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) .
The other function of vacuum pump is to provide sample cup with positive
pressure for bubble mixing. When the motor of vacuum pump reverses,
vacuum pump will provide positive pressure for vacuum chamber as the
power for mixing. It is different from other mixing modes—power is provided
by force pump only.
Sampling mechanism controls the probe for sampling, dilution and rinse etc..
23
Flow System
Figure 4-5
24
Flow System
25
Flow System
26
Flow System
27
Flow System
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 sampling probe and small syringe has air
leakage. Please check tubes.
3. Motor of small syringe cannot run normally.
28
Flow System
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.
29
Chapter 5 Test
Click ”Func”— “Sev”, input code ”1999” and click “OK” to enter System
Calibration screen, See Figure 5-1.
Figure 5-1 System Calibration
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.
30
Test
Table 5- 1
Reference Value Remark
Item Function Volume
Step
(mL)
Lyse consumption in Whole Blood
MA1 (900±100) 0.6 mL±0.05 ml
Mode
Lyse consumption in Pre-diluent
MA2 (800±100) 0.5mL±0.05mL
Mode
MA3 Probe Detergent consumption (370±30) 0.8 mL±0.05mL
Diluent consumption for WBC test in
MA4 (1200±100) 2.7 mL±0.2mL
Whole Blood Mode
Diluent consumption for RBC test in
MA5 (1000±100) 2.2 mL±0.2mL
Whole Blood Mode
Diluent consumption for WBC test in
MA6 (800±50) 1.7 mL±0.1mL
Pre-diluent Mode
Diluent consumption for RBC test in
MA7 (800±50) 1.7 mL±0.1mL
Pre-diluent Mode
The volume of
Sampling volume in Pre-diluent
MA8 (155±20) 0.35mL±0.02mL Diluent should
Mode
be enough for
2 test and the
MA9 Drain volume in Pre-diluent Mode (380±20) 0.8mL±0.02mL remain should
be 0.1mL
Liquid level
MA10 Sampling volume of blood sample should be
near 15μL
scale.
(1180)
(subject to
MA11 Sampling volume for second dilution current
technology
quantity)
Second Diluent consumption for
MA12 (470±30) 1.0 mL±0.05mL
WBC test in Pre-diluent Mode
Probe position of sample cup for Probe should aim at the
MC1
WBC test centre of sample cup
Probe should stretch into
sample cup and higher than
Probe sampling position of sample sample cup platform, do not
MD1
cup higher than 1mm. (subject
to current technology
quantity)
31
Test
NOTICE: Set time of WBC, RBC should be in accord with real test time
and no large deviation.
Input “1999” and click “Gain Adjust” on top left corner to enter the screen
shown as below.
32
Test
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
box, then input the gain value of control in
HGB_BACK is about 4.00V. Adjust the voltage as following: correct the value
in box, and click “OK” on lower left corner. Meanwhile the
33
Test
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 “Back” to
return to Main screen. See Figure 5-3.
34
Test
Press “Func”—“sev.”, input the code “2006” to enter Motor Check screen.
Operator could test MA, MC,MD motors and P1. P1 is for vacuum test. Click
corresponding test item button to check its condition. This operation is only for
test, operator could not correct the motor steps here.
Click “Valve Check” on top left corner of System Check screen to enter
corresponding screen as Figure 5-4 shows.
35
Test
Click “System Status Check” on top left corner of System Check screen to
enter corresponding screen as Figure 5-5 shows.
System Status Check screen presents current status information like
temperature, voltage of constant current source, 5V voltage, HGB_ZERO,
HGB_BACK, voltage and vacuum etc.. Click , 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.
36
Test
Click “Func”—“Sev” and input the code “2008” to enter Internal Calibration
screen. Operation of internal calibration is similar to that of external.
Internal calibration is for us internal use. External calibration is appropriate for
users. Both are equally effective.
37
Chapter 6 Software Upgrade and Online
6.1.1 Preparations
1. An U disk
2. Application program
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 4th USB port. See Figure 6-1.
3. Click “Func”—“Sev”, 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.
38
Software Upgrade and Online
6.2 Online
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.
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.
39
Chapter 7 Common Faults
Fault Cause
Power switch is ineffective 1. Power line connection fault;
2. Fuse blew out;
3. AC socket fault.
40
Common Faults
41
Appendix: Flow System
Lyse Detergent
Syringe Syringe
Micro
Syringe
UP
Cleaning
Cover
DOWN
Probe
(Rotary Diaphragm Pump)
Vacuum Chamber
UP
Vacuum
Board
LMS
Sensor
Vacuum (Mainboard)
Chamber
DOWN
DILUENT
Inlet
LYSE
Inlet
DETERGENT
Inlet
WASTE
Outlet
Code Description:
Plastic Connector/N420/410 (self-molding)/614-173 Quantity: 4 Sa: Plastic Tube (AAX02004)/607-
028
Plastic Connector/N420/410 (Value Plastics)/1306100006 Quantity: 1 Sc: Plastic Tube
(AAX02002)/607-027
Filter Body/601-114, Filter Cover/601-115, Filter Screen/601-118 Tpu: TPU Tube
1.4×3.2/1630100014
Quantity: 1 for each Ga:
Silicon Tube 2.4×5.5/603-033
T-3-way Connector/603-029 Quantity: 3 Pu:
PU Tube 2.5×4/614-154
N810 Blue Connector (processed)/614-165 Quantity: 2 Gd: Silicon Tube
6×10/603-053
42
Connector MTLP-1/603-021 Quantity: 1 Tc:
PTEF Tube 1.8×1.1/603-055