Service Manual PHOENIX NCC-3300 v15.05

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PHOENIX NCC-3300
Automated Hematology Analyzer

Service Manual

V15.05 eng 
CONTENTS 
COPYRIGHT .............................................................................................................................................. 3 
CHAPTER 1 SYSTEM DESCRIPTION .......................................................................................................... 6 
1.1 Front View ..................................................................................................................................... 6 
1.2 Rear View ...................................................................................................................................... 7 
1.3 Principles of Operation ................................................................................................................. 7 
1.3.1 Electrical Impedance Method ................................................................................................ 8 
1.3.2 WBCs Counting Principles ...................................................................................................... 8 
1.4 WBC Test Principle and Differential .............................................................................................. 9 
1.5 RBC Test Principles ...................................................................................................................... 10 
1.5.1 RBC Total Number Test Principle ......................................................................................... 10 
1.5.2 Test Principles of RBC Indexes ............................................................................................. 11 
1.6 Platelet Test Principle ................................................................................................................. 11 
1.7 HGB Colorimetric Method .......................................................................................................... 12 
CHAPTER 2 NOTICE ............................................................................................................................... 14 
2.1 External Factors .......................................................................................................................... 14 
2.1.1 Voltage ................................................................................................................................. 14 
2.1.2 Electromagnetic Interference .............................................................................................. 14 
2.1.3 Temperature ........................................................................................................................ 14 
2.2 Location Requirement ................................................................................................................. 15 
2.3 Notices for Startup ...................................................................................................................... 15 
2.4 Blood Samples Collection and Test ............................................................................................. 15 
CHAPTER 3 CIRCUIT ............................................................................................................................... 16 
3.1 Introduction ................................................................................................................................ 17 
3.1.1 Electrical System .................................................................................................................. 17 
3.1.2 Switched Mode Power Supply (SMPS) ................................................................................. 18 
3.1.3 ARM Board ........................................................................................................................... 18 
3.1.4 FPGA Board .......................................................................................................................... 19 
3.1.5 Analog Amplifier Board ........................................................................................................ 19 
3.1.6 Valves and Motors Drive Board ........................................................................................... 20 
3.1.7 AVDD Board ......................................................................................................................... 21 
 
  page 2 
 
3.1.9 Print Server Board ................................................................................................................ 22 
3.1.10 Reorder .............................................................................................................................. 22 
3.2 Electrical System Fault ................................................................................................................ 23 
3.3 Parameters Detection Principle .................................................................................................. 25 
CHAPTER 4 FLOW SYSTEM .................................................................................................................... 26 
4.1 Dilutor ......................................................................................................................................... 26 
4.2 Sample Cup ................................................................................................................................. 27 
4.3 Vacuum Pump ............................................................................................................................. 29 
4.4 Sampling Mechanism .................................................................................................................. 30 
4.5 Solenoid Valve ............................................................................................................................. 31 
4.6 Rolling Pump ............................................................................................................................... 31 
4.7 Vacuum Chamber ........................................................................................................................ 32 
4.8 JWLM Board ................................................................................................................................ 32 
4.9 LMS Board ................................................................................................................................... 33 
4.10 Function of Flow System Valves ................................................................................................ 35 
4.11 Flow System Fault ..................................................................................................................... 36 
CHAPTER 5 TEST .................................................................................................................................... 40 
5.1 System Calibration ...................................................................................................................... 40 
5.2 Gain Adjustment ......................................................................................................................... 42 
5.2.1 WBC, RBC Gain Adjustment ................................................................................................. 43 
5.2.2 HGB Voltage Adjustment ..................................................................................................... 43 
5.2.3 PLT Gain Adjustment ............................................................................................................ 44 
5.2.4 Vacuum Adjustment ............................................................................................................ 44 
5.3 System Check .............................................................................................................................. 44 
5.3.1 Motor Check ......................................................................................................................... 44 
5.3.2 Valve Check .......................................................................................................................... 45 
5.3.3 System Status Check ............................................................................................................ 46 
5.4 Internal Calibration ..................................................................................................................... 47 
CHAPTER 6 SOFTWARE UPGRADE AND ONLINE ................................................................................... 48 
6.1 ARM Board Software Upgrade .................................................................................................... 48 
6.1.1 Preparations ......................................................................................................................... 48 
6.1.2 Upgrade Process .................................................................................................................. 48 
6.2.2 Online Procedures ................................................................................................................ 50 
CHAPTER 7 COMMON FAULTS .............................................................................................................. 50 
 
  Page 3
 

Copyright 
 

Declaration
NeoMedica 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 manufacturer product. Other person 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 without NeoMedica

written agreement.

NeoMedica doesn’t make any form of guarantee for this manual, including (but not

limit to) implied guarantee responsibility on marketability and propriety lodged

for certain purpose. NeoMedica has NO responsibility for the error included in this

manual and indirect & abiogenetic damage that is caused by actual

representation & usage provided by this manual.

Content in the manual can be changed without giving notice.

Manufacturer’s Obligation:

NeoMedica is only responsible for instrument security, reliability and capability under

following condition:

Perform assembling, extending, adjustment, improvement and repair

by NeoMedica authorized person.

Relevant electrical equipment accord with national standard;

Follow Operation Manual to operate.

WARNING:

If each hospital or institution that is responsible for using this instrument cannot
 
  Page 4
 
realize a set of satisfactory service procedure, it will cause abnormal

invalidation of instrument, even harm personal health.

Nowadays, NeoMedica will provide relevant technical information conditionally when

customer request, in addition, state calibration method and other information in

list to help eligible technician to repair NeoMedica instrument.

Guarantee
Manufacture Technics and Materials

NeoMedica guarantees NCC-3300 automated hematology analyzer has no

technical and material problem within one year from shipping date if it is under

normal use and maintenance.

Free Service

NeoMedica’s obligation under this guarantee does NOT include freight and other fee.

NeoMedica is not responsible for direct, indirect, ultimate damage and delay caused

by following condition: improper use; replace accessories or repair analyzer by

person who is not authorized by manufacturer.

This guarantee is not applicable for following items: improper use; damaged

analyzer or the one which has NOT been maintained; NeoMedica original S/N label

or manufacture label has been replaced or tore off; other manufacturer’s

product.

Security, Reliability and Run Status

If following occur, NeoMedica is not responsible for the security, reliability and run

status of NCC-3300 automated hematology analyzer:

Disassemble, stretch and adjust analyzer’s assembly;

Repair or change analyzer by non-NeoMedica authorized person.

Send Back Analyzer


Procedure on Sending Back Analyzer
 
  Page 5
 
If user really needs to send back analyzer, please following the steps below:

Contact with NeoMedica sales company to get the right of return, inform S/N which

marked on outer pack. Analyzer with illegible label is NOT acceptable. Please

mark analyzer No. and S/N, briefly state return reason.

Freight:it is user’s liability for freight (including custom costs).

Version: V15.05

NeoMedica DOO

Bul. Cara Konstantina 82-86, 18000 Niš, Serbia

Tel: +381 (18) 573-820, +381 (18) 573-606, +381 (18) 533-935

Fax: +381 (18) 573-616

Web: www.NeoMedica.rs

Email: info@NeoMedica.rs

Supplyed by NeoMedica DOO

Wellkang Ltd t/a Wellkang Tech Consulting

Suite B 29 Harley Street, LONDON W1G 9QR, UK


 
  Page 6
 
Chapter 1 System Description 
 
1.1 Front View 
Display is a 10.4-inch LCD with a resolution of 640 × 480.  

3 2

Figure 1-1 Front Panel

1. Aspiration Probe
Aspirate samples.
2. RUN Key
Press the RUN key to startup the aspiration probe and then analyze specimen
only in the screens of main menu or Quality Control. At other screens, the RUN
key is invalid.
3. Recorder
Print the test result.

4. Touch Screen
10.4 inch LCD.
 
  Page 7
 

1.2 Rear View 
 

Figure 1-2

1.3 Principles of Operation 
NCC-3300 is a multi-parameter, automated hematology analyzer. It can
 
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display 21 parameters and 3 histograms. Analyzer adopts electrical impedance

method for WBC, RBC and PLT test and colorimetric method for HGB test.

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 
NCC-3300 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


 
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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

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 (35~450 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).
 
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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

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.
 
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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.

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.
 
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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 
 

NCC-3300 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).
 
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K is a constant.

EB is the luminous intensity of light passed through Diluent.

ES is the luminous intensity of light passed through sample.

1.8 Parameters
NCC-3300 generates following 21 hematologic measurements with

EDTA-anticoagulated human blood:

Table 1-1 21 Parameters

Abbreviation Full Name Normal 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 109cells/L

MID# Monocyte Count 0.1-1.8 109cells/L

GRAN# Granulocyte Count 2.0-7.8 109cells/L

RBC Red Blood Cell Count 2.0-7.8 1012cells/L

HGB Hemoglobin Concentration 110-150 g/L

HCT Hematocrit (relative volume of erythrocytes) 36.0-48.0 %

MCV Mean Corpuscular Volume 80.0-99.0 fL

MCH Mean Corpuscular Hemoglobin 26.0-32.0 pg

MCHC Mean Corpuscular Hemoglobin Concentration 320-360 g/L

RDW_CV Red Blood Cell Distribution Width repeat 11.5-14.5 %


precision

RDW_SD Red Blood Cell Distribution Width STDEV 39.0-46.0 fL

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


 
  Page 14
 
PCT Plateletcrit 0.10-0.28 %

P_LCR Large Platelet Percent 13-43 %

P_LCC Large Platelet 13-129 109cells/L

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 ºC to 35 ºC. 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.


 
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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)

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

Diluent, red for Lyse and yellow for Detergent.

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


 
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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.

Chapter 3 Circuit 
The circuit system is composed of switched-mode power supply (SMPS), ARM

board, FPGA board,valves and motors drive board, analog amplifier board,

print server board, button board, AVDD board, thermal printer (recorder), LMS

board and JWLM board. See Figure 3-1

Figure 3-1
 
  Page 17
 
3.1 Introduction 
3.1.1 Electrical System 

Figure 3-2 Left Side Door

Figure 3-3 Valve and Motor Drive Board


 
  Page 18
 
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 board, FPGA board, print

server board and thermal printer.

3.1.3 ARM Board 
ARM board is the control center of analyzer. The software is based on Linux,

which is responsible for data processing, print server and FPGA board control.

Figure 3-4 ARM Board


 
  Page 19
 
3.1.4 FPGA Board 
 

FPGA board is mainly used for software logic control and data collection,

provides parameters for ARM board and executes orders. See the Figure

bellow.

Figure 3-5 FPGA Board

3.1.5 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..


 
  Page 20
 

Figure 3-6 Analog Amplifier Board

3.1.6 Valves and Motors Drive Board 
Valves and motors drive board is the executive circuit unit for solenoid valves

and step motors.

Figure 3-7 Valves and Motors Drive Board


 
  Page 21
 
3.1.7 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.

Figure 3-8 AVDD Board

3.1.8 Button Board

Button board is for the shortcut keys on front panel. If one of the shortcut key

gets stuck, other shortcut keys cannot be used, and . the “RUN” Key is out of

order.

Figure 3-9 Button Board


 
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3.1.9 Print Server Board 
 

Print server board is for executing print order of recorder and external printer.

Figure 3-10 Print Servicer Board

3.1.10 Reorder 
 

Recorder uses thermal paper for printing. Thermal surface of the thermal paper

should face up. If the direction is wrong, recorder cannot work.


 
  Page 23
 

Figure 3-11 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 board cannot work normally.


 
  Page 24
 
Restart the analyzer. If it still cannot work, replace ARM board since it may be

damaged.

Phenomenon: Valves and motors work abnormally.

Troubleshooting: Turn off the power supply. Replace FPGA board due to the

damage of FPGA chip.

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 MB 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 board has no power, please

replace it.
 
  Page 25
 
3.3 Parameters Detection Principle 

Figure 3-12
 
  Page 26
 
Chapter 4 Flow System 
 

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

Figure 4-1

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


 
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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.

Figure 4-2 Dilutor

4.2 Sample Cup 
 

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,


 
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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, NCC-3300 could analyze cells by making

colorimetric analysis on blood sample with Lyse through lighting and receiving

part of WBC cup.

Figure 4-3 Previous Installation Method


 
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Figure 4-4 Latest Installation Method

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)


 
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Figure 4-5 Vacuum Pump

4.4 Sampling Mechanism 
 

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

Figure 4-6
 
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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 and provided by SMPS.

Figure 4-7

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 4-8 Rolling Pump


 
  Page 32
 
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

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 4-9 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
 
  Page 33
 
“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.

Figure 4-10 JWLM Board

4.9 LMS Board 
 

Counting time measurement unit is composed of 1 LMS board and 2 glass

tubes. It includes 4 optocouplers and 4 potentiometers. 4 optocouplers are

respectively corresponding to TEST1 to TEST4. Voltage of glass tube with

liquid is 4.8±0.2V, and for the one without liquid is 2.9±0.1V. Deviation of

optocoupler parameter points and contamination of glass tube inwall etc. will

lead to voltage deviation of TEST1—TEST4.


 
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LMS board is able to calculate aspirating liquid volume through detection

optocoupler and metering tube thus to ensure the measurement accuracy of

WBC, RBC and PLT. LMS board has 2 channels: one is WBC channel, the

other one is RBC and PLT channel. Each channel is compose of 1 metering

tube and 2 optocouplers. Before counting, V15 and V17 open to let air go into

WBC, RBC metering tube in LMS board for emptying liquid. When analyzer

starts counting, V15 and V17 close, liquid passes metering tube through ruby

aperture. Meanwhile the liquid column in metering tube starts falling. When it

passes though the top optocoupler, comparator outputs start counting signal;

when it passes though the bottom optocoupler, comparator outputs stop

counting signal.

Figure 4-11 LMS Board


 
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4.10 Function of Flow System Valves 

NO  Function   Remark(Valve Control Content) 

V1  Rinse (WBC)  Prime Detergent 

V2  Counting (WBC)  Prime, counting and flush

V3  Flush (RBC)  Mix sample and drain liquid

V4  Flush (WBC)  Mix sample and drain liquid

V5  Back flush  Back flushing with air produced by rolling pump

V6  Discharge air and liquid Drain Waste of vacuum chamber and establish
vacuum

V7  Probe Cleaning  Clean the outwall of probe

V8 Drain fluid Clean the outwall of probe and add reagent


into sample cup

V10 Dilutor aspiration Aspirate and drain Diluent

V14 Counting (RBC) Prime, counting and flush

V11 Sampling and dilution Collect and Dilute blood sample

V12 Control Diluent addition Control Diluent addition of WBC, RBC cup

V13 Prime(RBC) Prime Detergent

V9 Prime Lyse Aspirate and drain Lyse

V15 Drain Drain the liquid of LMS board in WBC channel

V16 Mixing (WBC) Mix sample with recoil air produced by rolling
pump

V17 Drain Drain the liquid of LMS board in RBC channel

V18 Mixing (RBC) Mix sample with recoil air produced by rolling
pump

 
 
  Page 36
 
4.11 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 CPU 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 bubbles

Troubleshooting:

1. Low vacuum or tube leakage, adjust vacuum and check flow system.

2. No reagent. Please replace reagent.

3. The set time of calibration is very different from the actual time. Correct it.
 
  Page 37
 
4. Optocoupler voltage of LMS board is too low, which cause false alarm.

Empty LMS board and adjust 4 optocouplers voltage to 2.9V.

Phenomenon: WBC/RBC clogs.

Troubleshooting:

1. Rinse and prime WBC/RBC cups with probe Detergent or remove the ruby

for cleaning, and check whether the voltage of the LMS board is normal.

2. If the liquid column of LMS board does not go down, it indicates the ruby

aperture has serious clog. At this moment, the test time may be 0.0 second.

Please prime the ruby aperture with probe Detergent.

3. 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;

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.
 
  Page 38
 
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.

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.


 
  Page 39
 
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: LMS liquid column drops

Troubleshooting:

1. Valve on the LMS board for emptying air is not closed well. Nip the tube

between the valve and LMS board to check whether the liquid column still

dropping. If does, it indicates the valve is not closed well; if not, there is no

problem with the valve.

2. Check whether the three-way connector has air leakage.

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.


 
  Page 40
 
Chapter 5 Test 
 

5.1 System Calibration 
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.


 
  Page 41
 
Table 5- 1

Item Function Reference Value Remark


Volume
Step
(mL)
MA1 Lyse consumption in / 0.65±0.03
Whole Blood Mode
*subject to current
technology quantity
MA2 Lyse consumption in / 0.59±0.03
Pre-diluent Mode
MA3 Probe Detergent / 1±0.1
consumption
MA4 Diluent consumption of 1200-1540 2.8±0.2
WBC cup in Whole
Blood Mode
MA5 Diluent consumption of 1200-1540 2.8±0.2
RBC cup in Whole
Blood Mode
MA6 Diluent consumption of 1200-1540 2.8±0.2
WBC cup in Pre-diluent
Mode
MA7 Diluent consumption of 1200-1540 2.8±0.2
RBC cup in Pre-diluent
Mode
MA8 Aspiration volume of 140-220 0.34-0.38 The volume of
mixture of Diluent and Diluent should
blood sample in Pre- be enough for 2
diluent Mode test and the
*subject to current remain should
technology quantity be 0.1mL
MA9 Diuent consumption for 350-420 0.78-0.86
mixing blood sample in
Pre-diluent Mode
*subject to current
technology quantity
MB1 First aspiration volume Liquid level should not
of blood sample from be lower than 5mm from
test tube 20μL scale. Meanwhile
*subject to current it should not be higher
technology quantity than 20μL scale.
MB2 Second aspiration Liquid level should not
volume of blood be lower than 5mm from
sample from WBC cup 20μL scale. Meanwhile
*subject to current it should not be higher
technology than 20μL scale.
quantity
MC1 Probe position at WBC Probe should aims at
cup the centre of WBC cup
 
  Page 42
 
MC2 Probe position at RBC Probe should aims at
cup the centre of RBC cup
MD1 Probe sampling Probe should stretch
position at WBC cup into WBC cup and
higher than WBC cup
platform, but is not
higher than 1mm.
MD2 Probe standby position The interval between
sampling arm and
cleaning cover is
3~5mm.Probe takes in
cleaning cover for 1mm.
MD3 Probe inject sample Probe should stretch
position into WBC cup and
higher than WBC cup
platform, but is not
higher than 1mm.
WBC_TIME 12.0s WBC test time
RBC_TIME 15.0s RBC test time
Note: Set time of WBC, RBC should be in accord with real test time and
no large deviation

5.2 Gain Adjustment 
Input “1999” and click “Gain Adjust” on top left corner to enter the screen

shown as below.
 
  Page 43
 

Figure 5-2 Gain Adjustment

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

box, then input the gain value of control in

box, click to adjust the gain. Operation of RBC


gain adjustment is basically the same. When finished, click “OK” on lower left corner
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

box, and click “OK” on lower left corner. Meanwhile the

voltage shown in will change too. The larger the channel


gain is, the lower the voltage will be, and vice versa.

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


 
  Page 44
 
5.2.3 PLT Gain Adjustment 
Gain of PLT is corrected by inputting value in box. Click

“OK” on lower left corner 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 box and click . Vacuum pump

will start pumping. When finished, vacuum value will be shown in 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 “Back” to

return to Main screen. See Figure 5-3.


 
  Page 45
 

Figure 5-3 Motor Check

Press “Func”—“sev.”, input the code “2006” to enter Motor Check screen.

Operator could test MA, MB, 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 “Valve Check” on top left corner of System Check screen to enter

corresponding screen as Figure 5-4 shows.


 
  Page 46
 

Figure 5-4 Valve Check

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 “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,


 
  Page 47
 

HGB_BACK, WBC voltage and RBC voltage 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.

Figure 5-5 System Status Check

5.4 Internal Calibration 
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 NeoMedica internal use. External calibration is appropriate

for users. Both are equally effective.


 
  Page 48
 
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 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.
 
  Page 49
 

Figure 6-1 USB Port

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)

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
 
  Page 50
 
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.

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, less counting time
and WBC, RBC bubbles;
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.
No Detergent No Detergent or the optocoupler for Detergent
detection is broken.
Motor fault 1. Diluter gets stuck or damaged, and it leads
to over-large motion resistance;
 
  Page 51
 
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 FPGA board and
ARM board is abnormal;
5. Positioning switch or optocoupler is
damaged.
Abnormal voltage 1. AVDD board is damaged;
2. FPGA board cannot collect misinformation
properly;
3. Analog board is damaged.
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 1. Loss control of analog board digital gain;
can not be adjusted 2. Analog board HGB circuit is damaged;
3. Connecting line between 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.
Printer fault 1. Poor contact of communication line between
print board and ARM board;
2. Print board is damaged.
Recorder fault 2. 1. Poor contact of communication line between
print board and recorder;
2. Recorder is damaged.
Abnormal temperature 1. Abnormal temperature;
2. Temperature sensor fault.
 
  Page 52
 
Appendix: Flow System

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