URIT 5160 Service Manual

March 18, 2023 | Author: Anonymous | Category: N/A
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URIT

 

URIT-5160/5180/5181 5-Part-Diff Auto Hematology Analyzer  

Service Manual Manual

U R I T M edi cal E l ect roni c C o. , Lt d.

 

 

CONTENTS  Copyright and Declaration ................................................................................................... ...................................................................................................I Chapter 1 Introduction ........................................................................................................ ........................................................................................................1 1.1

Front View............................................................................................................... ...............................................................................................................1

1.2

Rear View View ........................................................ ............................................................................................................... .......................................................2

1.3

Left View View ...................................................................... ................................................................................................................. ...........................................3

1.4

Fundamentals of Test ............................................................................................. .............................................................................................3

1.4.1

Cell Counting Principle of Electrical impedance ..............................................3

1.4.2

WBC Classification Classification Principle............................................................................4

1.4.3

Optical Classification Principle.........................................................................6

1.4.4

Test Principle of RBC Total Total Number of Electrical Impedance ..........................7

1.4.5

Test Principle of RBC RBC Indexes ............................................................... ......................................................................... .......... 7

1.4.6

Test Principle of PLT PLT ........................................................................................ ........................................................................................8

1.4.7

Test Principle of HGB.................................................................. ....................................................................................... .....................8

Chapter 2 Precautions ........................................................................................................9 2.1

External Factors ......................................................... ..................................................................................................... ............................................9

2.1.1

Volt Voltage age ............................................................................................................. .............................................................................................................9

2.1.2

Electromagnetic Interference .................................................................... ........................................................................... ....... 9

2.1.3

Temperature ......................................................... ..................................................................................................... ............................................9

2.2

Placement Requirements Requirements ....................................................................................... .......................................................................................9

2.3

Boot Notes ................................................................... .............................................................................................................. ...........................................9

2.4

Blood Sampling and Test Test ...................................................................................... ......................................................................................10

Chapter 3 Circuit ............................................................................................ ............................................................................................................... ................... 11 3.1

Introduction ........................................................................................................... ........................................................................................................... 11

3.1.1

Circuit frames ................................................................................................. ................................................................................................. 11

3.1.2

ARM (A8)_FPGA ............................................................. ........................................................................................... ..............................14

3.1.3

Analog Power Board ...................................................................................... ......................................................................................15

3.1.4 3.1.5

PreAmp Board ................................................................. ............................................................................................... ..............................16 OMC Board .......................................................... .................................................................................................... ..........................................17

3.1.6

JWLM Board ........................................................ .................................................................................................. ..........................................19

3.1.7

MV Driver ....................................................................................................... .......................................................................................................20

3.1.8

LMS Board ..................................................................................................... .....................................................................................................21

Chapter 4 Flow System ..................................................................................................... .....................................................................................................23 4.1 Position of Key Components ................................................................................... ...................................................................................23 4.1.1

Right Side View.............................................................................................. ..............................................................................................23

4.1.2

Left Side View ................................................................................................ ................................................................................................24

4.1.3

Front View ............................................................ ...................................................................................................... ..........................................25

4.1.4

Rear View....................................................................................................... .......................................................................................................26

4.2 4.3

Syringe Module ..................................................................................................... .....................................................................................................26 Transducers ................................................................. .......................................................................................................... .........................................27

4.4

Flow Diagram........................................................................................................ Diagram........................................................................................................28 I

 

Contents 4.4.1

Optical Flow System ...................................................................................... ......................................................................................29

4.4.2

mpedance Flow System ............................................................. ................................................................................ ...................30

Chapter 5 Optical System ................................................................... ................................................................................................. ..............................31 5.1

Optical Structure Structure ................................................................................................... ...................................................................................................31

5.2

Optical Schematic................................................................................................. .................................................................................................32

Chapter 6 Test ................................................... ................................................................................................................... ................................................................33 6.1 Motor and Valve Test............................................................................................... ...............................................................................................33 6.1.1

Valve T Test est ....................................................................................................... .......................................................................................................33

6.1.2

Motor T Test est ............................................................ ...................................................................................................... ..........................................33

6.1.3

Other Parameters T Test est ................................................................................... ...................................................................................34

6.2

Parameter

Adjustment ......................................................... ....................................................................................... ..............................35

6.2.1

Adjustment of Impedance Motor Step Steps s ..........................................................35

6.2.2

Optical Motor and Gai Gain n Adjustment ...............................................................37

6.2.3

Impedance Gain Adjustment ((WIC, WIC, RBC, PLT PLT, HGB and Vacuum Vacuum degree) ..39

6.3

Software Upgrade................................................................... ................................................................................................. ..............................41

6.3.1

SD Card Upgrade ............................................................ .......................................................................................... ..............................41

6.3.2

U Disk Upgrade ............................................................................................. .............................................................................................43

6.4

Skipping Self-checking Self-checking ........................................................... ......................................................................................... ..............................43

Chapter 7 Troubleshooting................................................................................................ ................................................................................................44 7.1

Optical Troubleshooting Troubleshooting ........................................................................................ ........................................................................................44

7.1.1

Stains on Sheath Flow Regulator .................................................................. ..................................................................44

II

 

 

Copyright and Declaration We owns the copyright of this unpublicized 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 have 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 representation & usage provided by this manual. Content in the manual can be changed without giving notice.  Applicable models: URIT-5160, URIT-5160, URIT-5180,URI URIT-5180,URIT-51 T-5181 81 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 equipments 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 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 and Declaration Guarantee Manufacturerr techniques and material Manufacture We guarantee that the automated hematology analyzer has no techniques and material problems within one year from shippingday 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: misuse ,  replaced accessories or repaired by personnel not authorized by us. This guarantee is not applicable for following items: Improper use; Without maintenance or damaged machine; URIT original serial number label or manufacturer logo has been replaced or torn off; Other manufacturers’ products.  products.   Security, reliability and run status If following conditions occur, we are not responsible for the security, reliability and run status of the analyzer Components have been disassembled, stretched and re-debugged. Serviced or changed not by our authorized personnel. Returns Return to vendor procedure If you need to return the product to URIT, please follow the steps below: You should get the right of return first, please contact the URIT sales company with product series number which marked on nameplate, we will not accept if S/N cannot be identified. Please mark the instrument No., S/N and why you return the product. Freight: if send back instrument for service, purchaser bears the freight (including custom fare)

Version: 02/2017

II

 

 

Chapter 1 1.1 

Introduction

Front View

Buttons on the front

Count button

housing

Indicator light 

Figure1-1 Front View

1

 

Chapter 1 Introduction

1.2 

Rear View

Cooling fan

Reagent interfaces

Figure1-2 Rear View Reagent interfaces: diluent, lyse, detergent, sheath, waste and level detection connector of waste container container

2

 

Chapter 1 Introduction

1.3 

Left View

PS2 interface of keyboard and mouse USB Internet access Reserved interface Serial port

Power switch

AC power plug Grounding column

Figure1-3 Left View View   1.4 

Fundamentals of Test URIT-5160 achieves WBC differential count with Multi-angle laser light scattering

technique and obtains the blood cell analysis via three independent detection channels. 1)

WBC/DIFF channel: channel: achieves achieves WBC count and classification with laser light scattering technology in the sheath flow regulator. Complete WBC count and classification in one channel.

2)

WBC/HGB channel: channel: WBC testing by electrical impedan impedance ce method, and hemoglobin testing by colorimetry.

3)

1.4.1 

RBC/PLT channel: RBC and PLT counting by Electrical impedance

Cell Counting Principle of Electrical impedance

Electrical impedance impedance of white blood cells (WBC) count principle which is based on the principle of non-conductive causes resistance change when blood cell granules in diluents go through the aperture. Take it as the basis for testing to count WBC and determine its volume.

3

 

Chapter 1 Introduction

Constant current source 

Counting chamber  

External electrodes  Internal electrodes  Outer chamber   Inner chamber   Cell suspension 

 Aperture  Figure1-4 Electrical impedance

Inner and outer electrodes are placed inside and outside the room in the counting chamber. The two chambers are separated by a ruby aperture with w ith a diameter of 100μm. The rear chamber is filled with a certain concentration of cell suspension, and the front chamber is filled with diluents. The cell’s conductivity which is lower than diluent’s conductivity, so is the relative poor conductor. When a cell granule in front chamber goes through the aperture, it generates an instantaneous pulse voltage between inner and outer electrodes. The number of of pulses is proportiona proportionall to the number number of cells. cells.

Pulse height is proportional proportional to

the size of the cell volume. Under the influence of negative pressure, a certain capacity of the cells will continue through the aperture, thereby generating a series of pulses. Send to count for obtaining a certain volume of total cells by pulse signals amplification, threshold adjustment, identification, identification, shaping and A / D conversion. (See Figure 1-4) 1.4.2 

WBC Classification Principle

URIT-5160 not only calculates the overall amount of WBC, but also offers graphics leukocyte distribution distribution - the scatter plot.

4

 

Chapter 1 Introduction

Figure1-5 Scatter Plot  When doing a normal human blood test by URIT-5160, scatter plots of most samples should be like the above figure. There’s clear cell grouping. In DIFF channel, the gray part which is the shadow cell area is the reflection in the scatter plot after the RBC dissolved in the sheath. (Some people have it and some do not have it.) The green is the lymphocytes, pink area is the mononuclear cells, blue area is the neutrophils, white area is the basophils group and the red area is the eosinophil group. There are obvious visible boundaries between each area. Cells with the same color come into group, and cells with different color separates.(See Figure 1-5) 

5

 

Chapter 1 Introduction

1.4.3 

Optical Classification Principle

Figure 1-6 Sheath Flow Regulator The whole blood samples are diluted with an appropriate proportion of sheath, white blood cell remains its original state approximately. Using flow cytometry to make the cells in a single arrangement flow. The scattering density can be measured through the laser beam detection zone. Different types of cells at different angles scattered light intensity is different different due to

the

differences differences of of cell cell size, size, cell

membrane and cell internal structure. Scattered light signals received by photodetector at each angle are converted into different amplitudes of the pulse signals. By analyzing the pulse signals of different angles, we can get the scatter plot which represents the cell volume and related information. WBC are classified by the distribution of the pulse signals and the scatter plot. (See Figure 1-6) 

6

 

Chapter 1 Introduction

Figure 1-7 Cells Feature Comparison 1.4.4 

Test Principle of RBC Total Number of Electrical Electric al Impedance

The detection principle of RBC is the same as that of WBC. In RBC count chamber, cells arranged in a certain capacity go through aperture (68μm) under   the negative pressure. Pulse is formed during this process. The total number and average volume of RBC are obtained according to pulse size and height. The RBC volume distribution histogram is shown in Figure 1-8. Normally, ratio of number of RBC and WBC is approximately 750:1, so it can ignore factors caused by WBC as testing the RBC. However, in some special pathological conditions, such as leukemia simultaneously with blood disease, may cause abnormal RBC count.

Figure1-8 RBC Volume histogram 1.4.5 

Test Principle of RBC Indexes

HCT=(MCV × RBC) /10. According to the relevant algorithm, the MCH and MCHC can be derived by RBC, MCV and HGB. RDW is obtained as testing RBC number and volume differences, which reflects the outer periphery of RBC volume heterogeneity. RDW which reflects the extent of RBC sizes, which has clinical significance for diagnosis of anemia. 7

 

Chapter 1 Introduction

1.4.6 

Test Principle of PL PLT T

Platelet (PLT) and RBC are tested in the same counting chamber. The analyzer respectively counts it according to different different thresholds. (See Figure 1-9) PLT data stores in 64 channels within the range of 2fL to 30fL.

Figure1-9 PLT  PLT Volume Distribution Diagram PDW is obtained according to the histogram and computer processing. MPV is the group arithmetic average volume of PLT histogram curve. Normal MPV and PLT amounts are non-linear negative correlation. PCT is drawn through the MPV and PLT.   1.4.7 

Test Principle of HGB

Hemoglobin (HGB) and WIC are tested in the same cup. Lyse destroys RBC and the HGB is dissolved out. Related ingredients combine to form an HGB complex. Colorimetric assay in specific wavelength (540nm) in counting chamber, absorbance change is proportional to HGB content in liquid. HGB test results are obtained by correlation algorithm.

8

 

 

Chapter 2 Precautions 2.1 

External Factors

2.1.1 Voltage To ensure the normal work and stable test, the analyzer uses 220V power input. High-precision automatic AC power supply should be installed as the electric supply is unstable. If intermittent power outages happen frequently, please install the UPS uninterruptible power supply, so as to avoid damage to the power and circuit board. 2.1.2 Electromag Electromagnetic netic Interference  Acquisition signal is very weak, external interference may cause abnormal abnormal data. re to avoid affecting the test Therefore, it’s recommended connecting with ground wi wire results by interference signal. Away from the equipments generated interference signals, such as monitors, copiers, centrifuges and X-ray detector. 2.1.3 Temperature The required operating temperature is 15 ℃~35℃. Temperature is too low which affects the reagents and test data. The most common is that hemolysis becomes slow because of low temperature, resulting in unusually high of WBC and HGB. PLT aggregates together because of low temperature, which makes low PLT data. 2.2 

Placement Requirements 1. Place the analyzer and reagents in the same horizontal plane to ensure reagent can be quickly added into the analyzer. 2. Waste containers should be placed on the ground. (Avoid waste overflowing) 3. Insert the reagent connectors. connectors. Diluents Diluents connect connect with the blue one, lyse connects connects with the red one, detergent connects with the green one and sheath connects with the yellow one.

2.3 

Boot Notes 1.

Check whether whether the tubing tubing connector connector of flow system looses or cracks. If so, please deal with it before boot.

2.

After boot, check whether there’s abnormal sound or smell, the screen display is After normal or not. If so, please shut down the analyzer immediately immediately and check it.

9

 

Chapter 2 Precautions Precautions  3.

Check whether whether the screen display display and program initialization is normal. Enter sample test interface if it’s normal.

2.4 

Blood Sampling and Test There are two sample test modes, which are whole blood and diluent. 1.

Whole blood blood sampling: sampling: collecting human blood blood by vacuum blood blood collection collection tube. tube. The anticoagulant in the collection tube anticoagulats anticoagulats the blood sample.

2.

Diluent sampling: collecting human peripheral blood with blood collection tube, such as fingers, ears and so on.

3.

Whole blood test: in Test interface, put the test sample under the aspiration probe and then press count button to test.

4.

Diluent test: test: put the disposable disposable test test tube under under the aspiration probe and and click “Drain” to automatically discharge 500μl diluent into the test tube. Collect 20μL peripherall blood and mix it in the test tube. Select “Diluent” mode in test interface, periphera put this tube under the aspiration probe and press count button on the front housing. The analyzer starts to test.

※Note: avoid squeezing when collecting peripheral blood so as not to extrude tissue

fluid or aggregate PLT, which may affects PLT counting. Needle goes a little bit deeper when collecting peripheral blood. Do not collect first drop of blood as sample.

10

 

 

Chapter 3 Circuit The circuit consists of switch mode power supply (SMPS), ARM(A8)_FPGA, OMC board, PreAMP board, MVDriver, JWLM board, AnalogPower board, LMS board, Light panels, LED_LOCK board, Front housing Keyboard, card reader and  Monitor driver.

3.1 

Introduction

3.1.1 

Circuit frames

Light path 

Impedancemotordrive board

Impedance-   PreAMP board 

Optical module control board

Figure3-1 Left Side Door

11

 

Chapter 3 Circuit 

LMS board

JWLM board

Figure3-2 Right Side Door

12

 

Chapter 3 Circuit 

A8 AMP Board AnalogPower board

A8 core

switch mode power supply (SMPS)

Figure3-3 The Rear

13

 

Chapter 3 Circuit 

monitor Driver

Front

housing

Keyboard

Front housing

card reader

Keyboar

 

Figure3-4 Back of Front Housing 3.1.2 

ARM (A8)_FPGA

 ARM (A8)_FPGA (A8)_FPGA which is the control center of the analyzer stores gain and motor steps. LED1 blinks as the A8 AMP board working. See Figure 3-5.

14

 

Chapter 3 Circuit  Touch

screen,

USB

interface, choose one of them

Interface Panel

key

of

Interface of display

PreAMP board

screen

interface FPGAprogramming Count

key

interface

interface Program download

Program download selection 2

selection 1 MVDriver  board Display power

A8 core

interface Interface

of

JWLM board

Interface of LMS board

 power

supply

input

CAN

interface

(connect

SD-TF Card slot

with

Figure3-5 ARM (A8)_FPGA 3.1.3 

Analog Power Board

 Analog Power board which is responsible responsible for system logic l ogic control provides various parameters and executes the command. See Figure3-9.  Analog power power board which is responsible responsible for provid provides es the ±12V analog power power supply to PreAmp board and OMC board, at the same time also provides the 5V power supply to optical laser and +12V to fan interface. As shown in Figure 3-6.

15

  

Chapter 3 Circuit 

+/-12V +-12V   power 电源 interface*2 接口*2 5V power 5V

电源接口

interface*2 *2

Fan +/-12V Power

风扇+12V 电  power

supply,

开关电源,

 power input 电源输入  

源接口 

interface*2

Figure3-6 Analog Power Board  Board  3.1.4 

PreAmp Board

PreAmp board, which amplifies and processes weak cellular signal of transducers, monitor the vacuum of impedance flow system’s negative pressure tank and current ambient temperature.

16

 

Chapter 3 Circuit 

12V

analog

 power input ARM (A8)_FPGA interface

Interface

of

impedance negative  pressure tank

Temperature Sensor interface

HGB interface

WBC interface

Interface

of

RBC and PLT

Figure3-7 AMP Board NOTE: please connect the pneumatic test’s tube system under the pressure sensor (near the ARM (A8)_FPGA interface). If not, the barometric pressure cannot be measured correctly. 3.1.5 

OMC Board

It’s mainly used to control the optical counting liquid circuit, analyze optical signal and upload optical signal to ARM (A8)_FPGA. See Figure 3-8.

17

  

Chapter 3 Circuit  Power supply input interface

开关电源输

Airway interface of

光学鞘液罐

入接口 

 pressure detection 气 压 检 测of 的

CAN   通信接 通信 接 CAN Communication Interface

气路接口 optics sheath tank  

口(与 A8 主

+/-

12V

(with 板)  ARM (A8)_FPGA)

analog

+-12V

 模拟

 power interface 电源接口 

MG   接 电机 MG interface  



MH   接 电机 MH interface

口 

V31

电磁阀 V31 90 ° d   信 signal interface 4号

电磁阀 V39 V39

接口 

90 °信号接 signal interface 3

口 

10 °信号接 signal interface 2

口 

V38

0°信号接 signal interface 1

电磁阀 V38

口 

电磁阀 V46 V46

MH   光 耦 接 MH Optocoupler KH)  interface口( (KH) MG

光学鞘液罐

Float sensor interface of

的浮子传感

  光耦接

器接口 

口(KG)  MG Optocoupler interface (KG)

optics sheath tank

Figure3-8 OMC Board NOTE: 1.

Pressure detection pipeline of optics sheath tank shall connect to the interface under the pressure sensor.

2.

Take AGND as the reference as testing the voltage voltage of S0, S10, S90 and S90D. (black probe of oscilloscope connects to AGND)

3.

The voltage voltage of S0, S10, S90 and S90D is magnified as these test points points passing through AMP module of OMC board. It’s not the original signal output via signal acquisition board, so inappropriate gain causes signal distortion.

18

 

Chapter 3 Circuit 

3.1.6 

Light panels(OPAMP) 

signal interface 1

signal interface 2

signal interface 3

Figure3-9 Light panels OPAMP 

19

 

Chapter 3 Circuit 

3.1.7 

JWLM Board

It mainly used to check reagents (diluent, lyse and sheath) and level detection of diluent reservoir. See Figure 3-10.

Interface

of

JWLM board

Figure3-10 JWLM Board Ensure the circled test point voltage (the test points corresponding corresponding to GND test points) is 2.9V±0.1V (adjust the potentiometers). Please adjust the potentiometers in state of no liquid in the flow line (also no printing on the flow line in optocoupler optocoupler position). 3.1.8 

MV Driver

MV Driver which is responsible for each motor motion in impedance flow system and for turning on and off solenoid valve pump.(See Figure3-11)  Please see the label for the interface of MV optocoupler. The corresponding optocouplerr of MA, MB, MC and MD is KA, KB, KC and KD. optocouple NOTE: Please make sure the jumper cap is in the correct installation state.

20

  

Chapter 3 Circuit  Power switch 13V, 开 关 电 源 24V input 13V,24V 输

Install the jumper cap,确保跳线帽以安 otherwise the 装,否则光耦无 optocoupler cannot

入 

法正常工作 work normally. 

Interface of A8 接 A8 主板的

motor valve

solenoid

电机电磁阀 接口 

Figure3-11  MV Driver Figure3-11 3.1.9 

LMS Board

Start optocoupler in RBC

Start

optocoupler

in

count 

WBC count 间开 耦 

End optocoupler in RBC

Adjustable potentiome potentiometer ter 

count in whole blood and diluent

End optocoupler in WBC count in whole blood and diluent

Figure 3-12 LMS Board 21

 

Chapter 3 Circuit  The test module for counting time consists of an LMS board and two glass tubes. There are 4 optocouplers and 4 potentiometers. 4 optocouplers corresponds to TEST1-TEST4 test points. The voltage is 4.8±0.2V when there’s liquid in the glass tubes. The voltage is 2.9±0.1V when there’s no liquid in the glass tubes. The voltage shall shift because of optocoupler parameter offset and dirty glass tube. The LMS board calculates the inhaled liquid by optocoupler and the metering tube, which ensures the measurement accuracy of WBC, RBC and PLT. There are two channels in LMS board, one is for WBC, the other is for RBC and PLT. Each channel consists of one measuring tube and two optocouplers. Open the valve which controls air, the air goes into the WBC measuring tube and RBC measuring tube. Empty liquid in the tube. Close the air control valve as test starting. Liquid in the counting chamber goes through aperture and flows to measuring tube. Liquid in the transducer goes through measuring tube, the liquid column is gradually moving down. The comparator output counts start signal as liquid column through the upper optocoupler. The comparator output stops counting start signal as liquid column through the down optocoupler. NOTE: as there no liquid in the glass tubes, the test point voltage TEST1-TEST4 should be adjusted within the range DC2.9V ± 0.1V, otherwise it may give a false alarm of clogging, bubbles or no reagents.

22

 

 

 

Chapter 4 Flow System 4.1 

Position of Key Components

4.1.1 

Right Side View

MD of sampling 采样机构纵 向电机 MD。 unit

MC of sampling 采样针横向 unit 电机 MC。 

计数玻璃管 Glass tubes  

Lyse 溶血剂注射 syringe, corresponding to 器,对应 MA MA 电机 

Diluents syringe, 稀释液注射 corresponding to 器,对应 MA MA 电机。 

Sampling syringe, 采 样 注 射 corresponding to 器,对应电 MB 机 MB

WOC WOC

WBC WBC

RBC RBC 样

样 品 transducer 杯。 

样 品 transd 杯。  ucer

品杯。   transducer 阻 抗 废 液 waste Impedance 泵 V19 (P1 )  pump V19 (P1)

Figure4-1 Key Components of Flow System (Right Side View) NOTE: lyse syringe and diluent syringe use one MA motor.  motor.   23

 

Chapter 4 Flow System

4.1.2 

Left Side View

Optical reservoir Optical

pressure

tank

Optical waste pump V46 Optical

sheath

 pump V44

Impedance mixing pumpV20(P2)

Figure 4-1 Key Components of Flow System (Left Side View)

24

sheath

 

Chapter 4 Flow System

4.1.3 

Front View

Cleaning set

Optical sheathing device 500uL

sample

syringe

(MH) 

Aspiration Optical

10mL

sheath

syringe(MG) 

Figure 4-3 Key Components of Flow System (Front View)

25

 probe

 

Chapter 4 Flow System

4.1.4 

Rear View

Impedance negative pressure tank

Diluents inlet tubing (blue)

Lyse inlet tubing (red)

Sheath

inlet

tubing

(yellow) Waste

Detergent inlet tubing

outlet

(green)

tubing (black ) 

Figure 4-4 Key Components of Flow System (Rear View)  View)  4.2 

Syringe Module

4.2.1 

Impedance Syringe Module The impedance syringe module consists of sample syringe (MB), lyse syringe (MA) 26

 

Chapter 4 Flow System and diluent syringe (MA). Function of sample syringe (MB):  

Sampling and store it iin n the aspiration probe temporarily temporarily

 

Send sample to the WOC transducer

 

Send sanple to the WBC transiducer transiducer

 

Collect diluted sample and send it tto o the the RBC RBC transducer transducer

Function of lyse syringe (MA): add lyse to WBC transiducer Function of diluent syringe (MA): add diluent to WBC transducer and RBC transducer The impedance of the syringe motor is driven by 24V. 4.2.2 

Optical Syringe Module The optical syringe module is consists of optical sheathing device 500uL sample syringe(MH)and optical 10mL sheath syringe(MG). Function of optical sheathing device 500uL sample syringe(MH): push sample into sheath flow regulator Function of optical 10mL sheath syringe (MG): add sheath to WOC W OC transducer The optical module of the motor is driven by DC12V.

4.2.3 

Description Syringe module consists of a small syringe, sampling syringe, ceramic syringes, motors, seals and other components. Three kinds of syringe can be individually disassembled for easy replacement replacement of the entire syringe, or replace seals. The motor and optocoupler of the syringe module are installed at the rear of the syringe, which avoids motor broken due to syringe leakage. The syringe drives the optocoupler guard sheet moving upwards, the syringe stops moving upwards as it arriving optocoupler. If the syringe is overtraveled (the syringe cannot run upwards and beeps), it is initially judged as the trip optocoupler failure.

4.3 

Transducers

 As shown in Figure 4-1 transducer components components which is the counting sensor of the analyzer is the most front-end detection element of data acquisition. WOC transducer is used to mix liquid. Measuring RBC, WBC and PLT parameters via Coulter principle (electrical impedance principle). In transducers, the circuit provides a constant current through diluted conductive liquid in cell counting. As cells go through aperture, the loop resistance changes. Cells with different volume produce electrical pulses with different amplitudes, so cells volume and numbers can be calculated. Make a Colorimetric analysis towards the treated sample and calculate HGB value via light emitting and receiving of WBC transducer. NOTE: the liquid should be sprayed on the walls of the transducer, or the results of MCV, PLT and HGB shall be affected.

27

  

Chapter 4 Flow System

4.4 

Flow Diagram 5160液路



Optical Module

光学模块

V31  NC

V34

U1

 NC  NO

SHEATH

V35

C

V36

 NO  NC

 NC

V32  NC



绿

Blue

Green



  红

C

WOC 10ml

Red

yellow

储液罐

V37

 

正压罐

 

Liquid storage pot Positive pot  NC

MG

V40  NC

 

V44

C

 NO

C

V33

500ul

V38

 

 NC NO

V46

V39

 NC

WASTE

 NC

MH

Impedance Module

阻抗模块

 NC

V5 C  NO  NC

V4  NO

C

V2

V18

V17

 NO

C

 NC

 

NC

 NC

V1 V3  NC

WBC

RBC  NC

MC

V7 V14

 NC

V8  

C C

 NO

 NC

V13

250ul

2.5ml

 NC

 NC

V11

LYSE

 NC

V6 C

V20

DETERGENT V9  NC

 NC

U2

计数真空罐

MA

 NO  NC

V10

10ml

V15

 NC

V12

 

 NC

MB

V16

MD

 NC NO

V19

WASTE

Figure4-5 Flow Diagram

28

DILUENT

Vacuum um  

   

Chapter 4 Flow System

4.4.1 

Optical Flow System

光学模块

Optical Module

V31  NC

V34

U1

 NC   NO

V35

C

SHEATH

 NO  NC

V32



绿

Blue

 NC



Yellow

  Red 红

V36

WOC 10ml

储液罐

V37  NC

 

正压罐

500ul

V38

 

V40  NC

V44

C

 NO

MG Liquid storage pot

V33

 NC

C

green

Positive pot

C  NC NO

V46

V39

 NC

WASTE

 NC

MH

  Figure4-6 Optical Optical Flow Diagram Diagram

 Add 1400μL sheath sheath into WOC cup by MG, MG, use MB syringe to collect 28μL blood and inject 18μL of it into WOC cup. MG sends sheath into WOC cup via V34, V35 and V37, V44 mixes blood and sheath via V40 and V39. Open the V34, V35 and V37, pump the mixed liquid into the channel between V34 and V37 by MG motor. The sheath is pushed by 160Kpa pressure to flow through V32 and into sheath flow regulator. It forms a sheath flow and wraps cells. Cells are in queue status. MH makes cells move upwards one by one. Cell sorting was performed under laser irradiation. The waste is pumped and discharged by V46.

29

 

Chapter 4 Flow System

4.4.2 

Impedance Flow System Impedance Module

Vacuum pump 

Figure4-7 Impedance Flow System Process explanation on sheath liquid channel (optical flow system) 1. MA (2.5ml) add lyse into WBC cup via V3. MA syringe which is used to absorb diluents into WBC cup and RBC cup via V1, V2, V4 and V5, pump diluents into clean sets via V1 and V2 , pump it to sample probe via V1, V2 and V4 to clean sample probe and clean set. 2. V19 pumps the liquid which is used to clean sample probe via V10, and pump the liquid which is used to clean RBC and WBC cups via V11 and V12. 3. MB (250μL) syringe is used to collect samples and give it to WOC cup and WBC cup. 4. V20 pumps the gas, open V15 V15 and V16, gas goes through these two v valves alves into the RBC cup and WBC cup. 5. The liquid goes through aperture aperture and reaches glass tube via V7 and V8 (open V17 and V18 to empty glass tube before testing), the count pressure tank offers 78KPa pressure, time counts by optocoupler of count board.

30

 

 

Chapter 5 Optical System 5.1 

Optical Structure Components of the optical system are shown below.

 No.3 signal receiver

 No.1 and No. 2

Figure5-1 Components of the Optical System

31

 

Chapter 5 Optical System

5.2 

Optical Schematic

Figure5-2 Optical Schematic

32

 

 

Chapter 6 Test 6.1 

Motor and Va Valve lve Test Click “Service” in test interface, input “1111” and click “OK” to enter valve test

interface. Click “Pre page”, “Next page” to switch valve test, motor test, system state test1 and system test 2. 6.1.1 

Valve Test

Click “Valve detection”, see Figure 6-1. 6-1.

Figure6-1 Valve Detection Click valves in the interface and the corresponding valves sounds except V41, V42, V43 and V45. V44 and V46 are pumps. NOTE: please click valves on a low frequency, since the analyzer takes a long time to react. 6.1.2 

Motor Test

Click “Motor detection”, see Figure 6-2. 6-2. Click items one by one to check them.

33

 

Chapter 6 Test

Figure6-2 Motor Detection  Detection  6.1.3 

Other Parameters Test

Click “System state detection 1”, 1”, see Figure 6-3.

Figure6-3 System State Detection 1 34

 

Chapter 6 Test Do not test the aperture voltage temporarily. If the test results are incorrect, there shall be something wrong with the corresponding corresponding circuit board. (Please adjust gain if blank voltage of HGB is out of range. Please see Chapter 6.2.3.) 6.2 

Parameter Adjustment

Click “Service” in test interface, input “5555” and click “OK” to enter the interfac e. Click “Pre page”, “Next page” to select Motor parameter, Optical parameter and gain parameter. 6.2.1 Adjustment

of Impedance Motor Steps

Figure6-4 Impedance Motor Steps and Counting Time Adjustment Click “OK” to save the edit. Parameter description description of key motors is shown in Figure 6-5. Initial position of aspiration probe

WOC Transducer

WIC Transducer

RBC Transducer

Figure6-5 Traverse motor of Sampling Unit  Unit  “MC1” represents the steps of sampling traverse motor from sampling position to 35

 

Chapter 6 Test WOC cup. It requests the aspiration probe to fall in the middle of WOC W OC cup. “MC2” represents the steps of sampling traverse motor from WIC cup to RBC transducer. It requests the aspiration probe to fall in the middle of RBC transducer. “MC3” represents represents the steps of sampling traverse motor from WOC cup to WIC W IC cup. It requests the aspiration probe to fall in the middle of WBC transducer. Descriptions of other parameter: Discharge

Parameter “MD1”   “MD1”

Default 

Description Downward movement distance of aspiration probe in standby station after counting

“MD2”   “MD2”

Distance of moving the aspiration probe to WOC cup

“MD3”   “MD3”

Distance of moving the aspiration probe to WIC cup

“MD4”   “MD4”

Distance of moving the aspiration probe to RBC cup

“MC1”   “MC1”

Steps of sampling traverse motor from sampling position to WOC cup

“MC2”   “MC2”

Steps Steps of sampling traverse motor from WIC to RBC cup

“MC3”   “MC3”

Steps Steps of sampling traverse motor from WOC to WIC cup

“MB1”   “MB1”

Sampling amount (CBC+DIFF)

“MB2”   “MB2”

Sampling amount in diluent mode (external) (CBC+DIFF)

“MB3”   “MB3”

Sample amount in WOC cup in whole blood mode

“MB4”   “MB4”

Sample amount in WOC cup in diluent mode

“MB5”   “MB5”

Sampling amount in whole blood mode (external) (CBC)

“MB6”   “MB6”

WBC=>RBC sampling amount (whole blood CBC+DIFF)

“MB7”   “MB7”

WBC=>RBC sampling amount (whole blood CBC)

“MB8”   “MB8”

WBC=>RBC sampling amount (diluent CBC+DIFF)

“MB9”   “MB9”

WBC=>RBC sampling amount (diluent CBC)

“MA1”  “MA1”  “MA2”   “MA2”

Addition amount of lyse (whole blood CBC+DIFF) Addition amount of lyse (diluent CBC+DIFF)

“MA3”   “MA3”

Unused

“MA4”   “MA4” “MA5”   “MA5”

amount

in

whole

blood

mode

(external)

 Addition amount of diluent (whole blood CBC+DIFF) WBC cup  Addition amount of diluent (whole blood CBC+DIFF) RBC cup

“MA6”   “MA6”

Addition amount of diluent (diluent CBC+DIFF) WBC cup

“MA7”   “MA7”

Addition amount of diluent (diluent CBC+DIFF) RBC cup

“MA8”   “MA8”

Unused

“MA9”   “MA9”

Discharge amount in diluent mode

“MA10”   “MA10”

Addition amount of lyse (whole blood CBC)

“MA11”   “MA11”

Addition amount of lyse (diluent CBC)

500uL

36

 

Chapter 6 Test “MA12”   “MA12”

Addition amount of diluent (whole blood CBC) WBC cup

“MA13”   “MA13”

Addition amount of diluent (whole blood CBC) RBC cup

“MA14”   “MA14”

Addition amount of diluent (diluent CBC) WBC cup

“MA15”   “MA15”

Addition amount of diluent (diluent CBC) RBC cup

“MA16”   “MA16”

Unused

6.2.2 

Optical Motor and Gain Adjustment

Click “Optics reference” to set it. See Figure 6-6. 6-6.

Figure6-6 Optics Reference Click ENTER in virtual keyboard to send the modified optics parameter value to OMC board for saving, otherwise, it’ll be lost.  lost.   Description of parameters parameters Name S0 S10 S90

Implication optical signal 1 gain adjustment optical signal 2 gain adjustment optical signal 3 gain adjustment

Range 20--255 20--255 20--255

optical signal 4 gain S90d MG_STEP1

adjustment WOC sheath addition amount in whole blood

20--255 0--65535 37

Description

 

Chapter 6 Test mode, used to dilute sample MG_STEP2

WOC sheath addition amount in diluent mode Motor

MG_STEP3

MG_STEP4

steps

controlling

of WOC

sampling amount diluent mode

in

Motor

of

steps

controlling sampling

0--65535

WOC amount

in

0--65535

0--65535

whole blood mode WOC sample counting MH_STEP1

steps in whole blood

0--65535

mode MH_STEP2

WOC sample counting steps in diluent mode

MH_STEP3

Undefined

MH_STEP4

Undefined WOC mixing

MG_FRQ1

adjustment

0--65535

delay

in

whole

mixing

delay

0--65535

blood mode WOC MG_FRQ2

adjustment in diluent

0--65535

mode MH_FRQ1 MH_FRQ2

Undefined  Adjustment

of

WOC

reaction time

0--65535

Recommended

values:

4000

(T=4000*2*5000/(10E-7)=4s ) 

Debugging

 ADFRQ

Optical ADC sampling rate setting

dedicated,

0xAABB,AA is the duration of high

do not change it.

level of the sampling square wave, BB the duration of low level(unit is

(default

0.01uS) 

65535: 4M) Blank voltage VB= BACKMIN/2 mV BACKMIN

Blank voltage of optical signal 1

0--8191

Only the sampling points which are higher than VB shall be processed. Only those points shall be included in the pulse width.

WIDTHMIN

Minimum pulse width

The pulse width which is greater 0--65535

setup WIDTHMAX

Maximum pulse width

than the value is considered a cell signal.

0--65535 38

The pulse width which is smaller

 

Chapter 6 Test setup

than the value is considered a cell signal. When the peak value of the recognized pulse signal is greater

FIFOPEAK

Peak threshold setup

0--65535

than this value, it is stored in the FIFO,

otherwise

discarded

(considered to be interference)

6.2.3 

Impedance Gain Adjustment (WIC, RBC, PLT PLT, HGB and Vacuum Vacuum degree)

Check the gain of RBC, WIC and PLT, check HGB blank voltage and check vacuum degree after testing by control material.  

WBC Click “Setup”“Setup”-“Service”, input “6666” and choose to open WIC histogram in popup dialog box. As shown in Figure 6-7, the abscissa of the second crest is got.

Figure6-7 WBC Histogram  Histogram   

RBC Click relevant figure to enter the interface. Move the coordinate line to the crest position to get the RBC coordinate value. value.

39

 

Chapter 6 Test

Figure6-8 RBC  RBC   

PLT Click relevant figure to enter the interface. Move the coordinate line to the crest position to get the PLT coordinate value.

Figure6-9 PLT  PLT  40

 

Chapter 6 Test  

HGB blank voltage (refer to Section 6.1.3) Click “Setup” → “Service”, input “1111” and choose “System state detection 1” in popup dialog. See Figure 6-3.

 

Va Vacuum cuum degree Click “Setup” → “Service”, input “5555” and choose “gain adjustment” in popup dialog. Click “Vacuum” to check vacuum value.  value.  If the peak abscissa of WIC, RBC and PLT is out of range, if the HGB blank voltage and vacuum doesn’t meet requirements, please pleas e adjust it in the gain adjustment interface. Click “Setup” → “Service”, input “5555” and choose “gain adjustment” to enter the interface. See Figure 6-10. 6-10.

Figure6-10 Gain Adjustment Adjustment   Click “Vacuum” and “HGB Blank voltage” to check the current value. If adjusting a djusting the WBC gain, RBC gain or PLT gain, please return to do QC test and check whether WIC gain, RBC gain and PLT gain is in the range. If it is out of range, please modify it till it falling in the range. 6.3 

Software Upgrade

6.3.1 

SD Card Upgrade



  Insert the prepared SD card into the SD card slot. For the position position of slot, slot, please see figure 6-13.

 

Push “1” of SW5 upwards and push “2” of SW5 downwards. See Figure 6 -11. 41

 

Chapter 6 Test  

Push “1” of SW2 upwards  upwards 

 

Turn off the power for 5 seconds and turn on it again. again. It enters enters program program upgrading upgradin g interface.

 

Remove the SD card as seeing “the upgrade is completed”.

 

Turn off the power, reset SW5 and SW2. SW2. Turn on the power after 5 seconds. Successful boot means successful program upgrading.

Figure6-11 SW5

Figure6-12 SW2  SW2 

42

 

Chapter 6 Test

SD card slot

Figure6-13 ARM (A8)_FPGA  (A8)_FPGA  6.3.2 

U Disk Upgrade

 

Insert the U disk into a USB port

 

Enter test interface

 

Click “Setup”“Setup”-“Service”, input “5555” and click “OK”  “OK” 

 

“the upgrade is completed” comes out, reboot the analyzer  

 

If upgrading upgrading fails, please insert the U disk into another another USB port and and repeat repeat step 3.

6.4 

Skipping Self-checking Self-check ing Long press the count button on the front housing to access main interface as seeing

in the upper left corner of the screen. Use this method when maintaining on the client side.

43

 

 

Chapter 7 Troubleshooting 7.1 

Optical Troubleshooting

7.1.1 

Stains on Sheath Flow Regulator

Wrong optical classification, it cannot be clearly classified the blood sample to 3 cell populations, or scatters only appear in a straight line on S0 image. Click “Setup”“Setup”-“Service” , input “2006” and click “S0Back” to see optics signal 1 (0°) blank voltage. If the blank voltage is greater than 2.5V, it preliminarily considered that the sheath flow regulator is dirty. There are two conditions, which are dirty inner wall and dirty outer wall. Wipe around the sheath flow regulator with a clean cloth and then check the S0 blank voltage. If it is less than or equal to 2.5V, it represents the outer wall is dirty. Make a fresh blood sample test; if the results are meets requirements, problem is solved. If the S0 blank voltage doesn’t change, it is considered con sidered that the inner wall is dirty. Cleaning method: click “Setup”“Setup”-“Service”, put the detergent under the aspiration probe and click “Soak sheath flow regulator”. Make two blank tests after soaking and check the S0 blank voltage. If it is less than or equal to 2.5V, please make a fresh blood sample test.

44

 

 

Manufacturer Name:URIT Medical Electronic Co.,Ltd.  A  Ad d dr e s s :N o . 3 E a s t A ll ey, J i u h u a Ro a d, Gu i l i n, Gu a ng x i 5 4 10 0 1 , PR C h i na Tel:+86 (773) 2288555 2288558 Fax:+86(773) 2288559

2824559

400 service hotline: 400-727-2288 Web:www.urit.com E-mail:[email protected] 45

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