Pe 6800 7service Manual

PE-6800

FULLY AUTO HEMATOLOGY ANALYZER

SERVICE MANUAL

Procan Electronics Inc.

Fax: (+86) 755 26747910 Tel: (+86) 755 26516667, 26952867 High-tech Industrial Park, Nanshan,Shenzhen 518057, P.R. China Gaoxin C. 1st Ave., 5/F., 4thBldg.,NO.2,

CONTENTS

CHAPTER 1 INSTRUMENT INTRODUCTION... 1

1.1 STRUCTURE ...1 1.1.1 Host ...1 1.1.2 Accessory ...1 1.2 PURPOSE...2 1.3 SPECIFICATIONS ...3 1.4 STRUCTURE ...7 1.4.1 Front Panel...7 1.4.2 Rear panel...7 1.5 OPERATION ...9 1.5.1 Display Screen...9 1.5.2 Menu...9 1.6 DETECTIONPRINCIPL ...12 1.6.1 Detection Principles of WBC, RBC, PLT...12 1.6.2 Principles of HGB Measurement...13

1.6.3 Volume Distribution of Blood Cell...13

1.6.4 Results and Calculation of Parameter Measurement ...14

CHAPTER 2 HARDWARE... 16 2.1 CPUBOARD...16 2.1.1 Function...16 2.1.2 Interface...17 2.2 CCUBOARD ...17 2.2.1 Function...17 2.2.2 Front Interface ...17

2.3 TFTCABLE CONVERTING BOARD...19

2.3.1 Function...19 2.3.2 Interface...19 2.4.LCD ADOPTER...20 2.4.1. Function ...20 2.5RECORDERBOARD ...21 2.5.1 Function ...21 2.6DOM CARD...21 2.6.1 Function ...21 CHAPTER 3 TUBING... 22 3.1TUBINGGRAPH...22

3.2 STRUCTUREOFTUBINGSYSTEM...23

3.2.1 Liquid road structure...23

3.2.2 Tubing Sensor Unit...23

3.2.3 HGB Unit...24

3.2.5 Vacuum Unit...24

3.2.6 Auxiliary Unit...24

CHAPTER 4 SYSTEM STRUCTURE... 25

4.1DISASSEMBLE/REPLACEPARTSANDCOMPONENTS...25

4.1.1 Disassemble/Replace the Sample Machine...25

4.1.2 Disassemble/Replace the Diluent Machine ...26

4.1.3 Disassemble/Replace the Vacuum Block...26

4.1.4 Disassemble/Replace the Vacuum Pump Block...27

4.1.5 Disassemble/Replace the Piston Block...28

4.1.6 Disassemble/Replace Chamber...29 CHAPTER 5 ADJUSTMENT ... 31 5.1 GENERAL...31 5.2 ADJUSTPROGRAM ...31 5.3 ADJUSTPLACE ...32 CHAPTER 6 MAINTENANCE ... 33 6.1 ROUTINEMAINTENANCE...33

6.1.1 Clean the Appearance of the Instrument...33

6.1.2 Replace Fuse...34

6.2 DAILYMAINTENANCE ...34

6.3 WEEKLYMAINTENANCE ...34

6.4 MONTHLYMAINTENANCE ...35

6.5 YEARLYMAINTENANCE...35

6.6THEMAINTENANCEBEFORETRANSPORTORFOR INSTRUMENTTHAT WILLNOTBEUSEDFORALONGTIME. ...35

CHAPTER 7 TROUBLESHOOTING ... 37

7.1PROGRAMTEST ...37

7.2 CHECKINGITEMSBEFOREMAINTENANCE ...38

7.3 BACKGROUND CHECK...38

CHAPTER 8 APPENDIX 1 LEAD LABEL... 41

CHAPTER 9 APPENDIX 2 DEBUG RECORD FORM ... 42

Chapter 1 INSTRUMENT INTRODUCTION

1.1

STRUCTURE

1.1.1 Host

Control the process of sample collection, dilution and analysis, including the following units: Hematology analyzer Switch parts Backboard parts WBC chamber RBC chamber Liquid tubing TFT cable

CCU board CPU Board System software

Former cover parts

Liquid Sensor Power supply Transformer

Dilution machine Dilution block Vacuum pump machine Vacuum pump

block

Glass bulb

Adapter PCBA Sample machine

1.1.2 Accessory

Including the following accessories: 1. PS/2 mouse. PS/2 keyboard.

waste cap components;

3. PS232 Communication cable; 4. Waste barrels;

5. Printer (Optional ), Bar code scanner (Optional )

1.2

PURPOSE

It is used for detecting the parameters of RBC, WBC, HGB and differential counter.

The analyzer is used for the determination of the following 20 parameters and 3 histograms blood specimens in Table 1-1.

Item Abbreviation Unit

White blood cell or leukocyte WBC 109/L

Lymphocyte LYM# 109/L

Mid-sized cell MID# 109/L

Granulocyte GRAN# 109/L

Lymphocyte percentage LYM% %

Mid-sized cell percentage MID% %

Granulocyte percentage GRAN% %

Red Blood Cell or erythrocyte RBC 1012/L

Hemoglobin Concentration HGB g/L

Hematocrit HCT %

Mean Corpuscular(erythrocyte) Volume MCV fL

Mean Cell Hemoglobin MCH pg

Mean Cell Hemoglobin Concentration MCHC g/L

Red Blood Cell Distribution Width- Standard

Deviation RDW-SD fL

Red Blood Cell(erythrocyte) Distribution

Width Coefficient of Variation RDW-CV %

Platelet PLT 109/L

Mean Platelet Volume MPV fL

Platelet Distribution Width PDW %

Plateletcrit PCT %

Plateletcrit-large Cell Ratio P-LCR %

White Blood Cell Histogram WBC Histogram Red Blood Cell Histogram RBC Histogram Platelet Histogram PLT Histogram

1.3

SPECIFICATIONS

„

According to anti-electrical shock hazard: Grade II, Pollution 2

According to the defence for deleterious liquid: General Device (Closing device of non-defensive liquid)

According to the recommended disinfection/sterilization method of the manufactory: Disinfectant device recommended by manufactory.

According to safety degree in condition that using gas mixture of flammable anesthetic gas and air or gas mixture of oxygen and nitrous oxide: Do not use the equipment in condition that using gas mixture of flammable anesthetic gas and air or gas mixture of oxygen and nitrous oxide.

According to working status: Continuous Running Equipment.

„

Blood Cells are counted and sized by Electrical Impedance Method. Hemoglobin is determined by Colorimetry Method.

„

Item Abbreviation Unit

White blood cell WBC 109/L

Red Blood Cell RBC 1012/L

Hemoglobin Concentration HGB g/L

Platelet PLT 109/L

Derived from Histograms:

Item Abbreviation Unit

Lymphocyte percentage LYM% %

Mid-sized cell percentage MID% %

Mean Corpuscular(erythrocyte) Volume MCV fL Red Blood Cell Distribution Width Standard

Deviation

RDW-SD fL

Red Blood Cell(erythrocyte) Distribution Width Coefficient of Variation

RDW-CV %

Mean Platelet Volume MPV fL

Platelet Distribution Width PDW %

Plateletcrit-large Cell Ratio P-LCR %

Calculated Parameters:

Item Abbreviation Unit

Lymphocyte LYM# 109/L

Mid-sized cell MID# 109/L

Granulocyte GRAN# 109/L

Hematocrit HCT %

Mean Cell Hemoglobin MCH pg

Mean Cell Hemoglobin Concentration MCHC g/L

Plateletcrit PCT %

„

Venous and Capillary Blood Mode:

Prediluted Mode: WBC/HGB 1:355

RBC/PLT 1:44500 Cell Counting Aperture Size:

WBC/RBC: 80μm „ Display

Liquid Crystal Display (LCD),resolution:640×480 „ Language

English „ Indicator

20 Parameters and 3 Histograms Display Alarm Indicator

Working Status (including Power Supply) Indicator Light Alarm

„ Interface

One power input socket One printer port One VGA display port Two RS232/C serial ports Two USB interfaces Two PS/2 interfaces „ Recorder

Rapid Thermal Recorder Recording width: 48mm Paper width: 57.5mm

„ Cable adapter board, Liquid Sensor, Voltage

When the liquid reagent is in the sensor the voltage is 3.0V ~ 5.0V; When the liquid reagent is not in the sensor the voltage is ≤1.5V。

„ Pre-dilution draining capacity

Pre-dilution draining capacity range should be 8.0±0.4ml „ Aperture voltage reference value

WBC Aperture voltage reference value：the 5 times average W.H.V.S value of blank test RBC Aperture voltage reference value：the 5 times average R.H.V.S value of blank test. „ Aperture voltage

Press T1 voltage range 9-20V

Press T2 voltage range less than 3V

„ Chamber cover and frame.

have been set the resistance value) to measure the Chamber shield and substrate Insulation. The value should be more than 20MΩ。When you finish test, return the electrode cable back. The value should less than 1Ω。

„ Screen Display and the Ranges for Report Output Parameters

Parameter Parameter Range Parameter Parameter Range

WBC 0.0 - 99.9x109/L GRAN# 0 - 99.9x109/L RBC 0.00 - 9.99x1012/L HCT 0.0 - 100.0% HGB 00.0 - 300g/L MCH 0.0 - 999.9pg PLT 0 - 3000x109/L MCHC 0.0 - 999.9g/L MCV 0 - 250fL RDW-SD 0.0 - 99.9 fL LYM% 0 - 100% RDW-CV 0.0 - 99.9% MID% 0 - 100% PDW 0.0 - 30.0% GRAN% 0 - 100% MPV 0.0 - 30.0fL LYM# 0 - 99.9x109/L PCT 0.0 - 9.99% MID# 0 - 99.9x109/L P-LCR 0.0-99.9% „ Operating Ambient Temperature: 15℃~35℃ Humidity: 10~90%

Atmospheric Pressure: 86.0kPa ~106.0kPa

„ Ambient Storage

Temperature: -10℃~40℃ Humidity: ≤80%

Atmospheric Pressure: 50.0kPa ~106.0kPa „ Electric Specifications

Power Supply: AC 100-240V, 50±1Hz,

The maximum input consumption is 150VA Fuse: AC 250V 2A

„ Dimensions and Weight Dimensions: 394mm×381mm×500mm Weight: 23kg

1.4

STRUCTURE

1.4.1

Front Panel

1. Power Light 2. [START] Key 3. Sample Needle 4.Display Screen 5. Thermal Recorder

（17） （15） （16） （14） （13） （12） （11） 10）（ （9） （18） （7） （8） （6） （5） （4） （2） （3） （1） chart 1-2

1. Equipotentiality 2. PS/2 Keyboard Interface 3. PS/2 Mouse Interface 4. Printer Interface 5. USB Serial Interface 6.VGA Display Interface 7. RS-232 Serial Port 1 8.RS-232 Serial Port 2 9. Air Filter 10. Power Switch 11. Socket for Power Input 12. Fuse Holder

13. RINSE Connector 14. DILUENT Connector 15. WASTE Connector 16.WASTE Sensor Connector 17. LYSE Connector 18. Air Filter

1.5

OPERATION

Designed according to human engineering and transferring information to users by software windows and mouse, both are convenient for your operating.

1.5.1

Display Screen

The display screen is classified five sections:

SYSTEM TIME SECTION INFORMATION SECTION SHORTCUT KEY SECTION

WINDOWS DISPLAY SECTION

AUXILIARY OPERATION SECTION

Figure 1-3 „ SYSTEM TIME SECTION

Display the current date and time of the system. „ INFORMATION SECTION

Display prompt information of the system. „ SHORTCUT KEY SECTION

To display the function interfaces of the system. „ WINDOWS DISPLAY SECTION

Display various results.

„ AUXILIARY OPERATION SECTION Display the information of user.

1.5.2

Menu

You can operate the instrument by menu. Press the right key of the mouse, directing to the function menu of the current window. Move the mouse to the required menu bar, and then press the left key of the mouse, the required function will be selected. Pressing the left key out of the

menu area, the operation will be canceled.

The common functions are showed at the top right corner of the screen as shortcut key. Move the mouse to the function you wanted.

The menu functions are as follows:

Sample Mode: Choose the sample mode among Venous Blood Mode, Capillary Blood Mode and

Prediluted Mode.

Diluent: Inject the diluent quantificationally by sample needle. This menu uses only in Prediluted

Mode.

Information: Enter the information window of the next sample, input and modify the

information.

Histogram: Enter the histogram adjustment window of the current sample. You can manually

adjust the histograms of the current sample.

Print: Output the data of the current sample to the appointed device.

Function: Enter the function menu.

Mute: Stop the alert.

Help: Access the system help window.

About: Display information of the instrument such as software and copyright etc.

Shutdown: Startup the shutdown program to rinse the measurement unit automatically. Shutoff

the power supply when the screen displays “Please switch off”.

Function Menu

Review: Enter the review window. You can review, inquire or modify the measurement data of the

former sample.

Calibration: Enter the calibration window to calibrate the instrument.

Quality Control: Enter the quality control window to carry out quality control operation.

Setting: Enter the setting menu.

Service: Enter the service menu.

Calibration Menu

Auto Calibration: Enter the auto calibration window to adjust the instrument automatically.

QC Menu

QC Edit: Enter the QC edit window to edit the QC parameters.

QC Run: Enter the QC run window to carry out the selected QC files.

QC Graphs: Enter the QC graphs window to browse the selected QC graphs.

QC Table: Enter the QC table window to browse the selected QC tables.

Setting Menu

Time: Enter the time setting window to set the time of the instrument.

Printout: Enter the printout window to set the functions such as print or report.

Config: Enter the config window to set the functions such as print, sleep, clean, and display etc.

Limits: Enter the limits window to modify the limits.

Department: Enter the department window to set the department and abbreviation.

Operator: Enter the operator window to set the department, abbreviation, department and

operator.

Service Menu

Flush: To get rid of the aperture clog.

Enhanced Flush: To get rid of hard aperture clog.

Cleaning: Run the normal rinse process to rinse the measurement unit.

Enhanced Cleaning: Rinse the measurement unit with RINSE.

Drain Chambers: Empty the liquid of the counter pool.

Park: Run the Park Program to rinse and empty the tubing.

Prime Diluent: Inject the Diluent to the appointed tubing.

Prime Lyse: Inject the Lyse to the appointed tubing.

Prime Rinse: Inject the Rinse to the appointed tubing.

Maintenance: Run the maintenance program to maintain the instrument.

Special: Enter the Special window to maintain the instrument.

1.6

DETECTION PRINCIPL

1.6.1

Detection Principles of WBC, RBC, PLT

The count principle of the instrument is based on the measurement of changes in electrical resistance produced by a particle passing through an aperture sensor.

a) The sample blood is diluted in a conductive liquid. As blood cells are non-conductive, the diluent is a good conductor. There are big differences between them.

b) When the diluent passes through the aperture sensor, electrodes are submerged in the liquid on each side of the aperture to create continuous current.

c) When cells pass through the aperture, the resistance between the electrodes increases as the cell volume increasing, as is shown in figure 1-4.According to the Ohm Formulary: U=RI (U=Voltage I=Current R=Resistance).If I is a constant, U increases as the cell volume

increasing.

d) Passing through the magnification circuit, the voltage signal will be magnified and the noise will be filtered, then you will gain the analytical results, as shown in figure 1-4.

e) One count pool and the detection circuit count the WBC. Another count pool and the detection circuit count the RBC and PLT. The microprocessor of the instrument calculates and analyzes the cells (WBC, RBC, PLT), and then gives out the histograms.

f) PLT count adopts advanced liquid, electronics and software system. It settles the repetitive count of the cells on the side of the aperture count area.

Figure 1-4

1.6.2

Principles of HGB Measurement

Adding lyse in the blood, the red blood cell will rapidly be broken down and release hemoglobin. Hemoglobin and lyse form a new mixture, which can absorb the wavelength of 540nm.Measure the absorbency. Through the comparison of the absorbency between the pure diluent and the sample，the concentration of the sample hemoglobin is calculated.

1.6.3

Volume Distribution of Blood Cell

When different types of cells pass through the aperture sensor, there will be different electrical pulse height. Because of the evident difference of the cells sizes, the instrument is able to differentiate the white blood cell, red blood cell and platelet by its pre-set program.

The volume distributions are as follows: WBC 120～1000fL

RBC 82～98fL PLT 2～35fL

The leucocytes disposed by lyse can be divided into three types, according to their volumes: lymphocyte (LYM), mid-sized cell (MID), Granulocyte (GRAN).

LYM 35～90 fL MID 90～160 fL

GRAN 160～450 fL

1.6.4

Results and Calculation of Parameter Measurement

The parameters of the sample blood test can be described in three ways: a) Measured directly, such as WBC, RBC, PLT, HGB.

b) Derived from histograms, such as LYM%, MID%, GRAN%, MCV, RDW-SD, RDW-CV, MPV, PDW, P-LCR.

c) Calculated, such as LYM#, MID#, GRAN#, HCT, MCH, MCHC, PCT. The derivation of the formularies as follows:

z MCV derives from histograms and the instrument collecting and classifying the erythrocytes according to its volume. It is determined by measuring the average volume of individual erythrocytes, and the unit is fL.

z RDW represents the volume distribution of the erythrocyte populations, derived from the RBC histogram. It can be expressed by the coefficient variation of the erythrocyte volume as RDW-CV, and the unit is %.It can also be expressed in standard deviation of the erythrocyte volume as RDW-SD, the unit is fL.

z MPV is the average volume of individual platelets, derived from the PLT histogram. It represents the mean volume of the PLT populations and can be expressed in fL.

z PDW derives from the PLT histogram. It represents the geometry standard deviation (10 GSD) of the volume of the PLT populations.

z P-LCR derives from the PLT histogram. It represents the ratio of the larger PLT and the unit is %. z HCT(%)= RBC×MCV/10 z MCH(pg)= 10×HGB/RBC z MCHC(g/L)= 100×HGB/HCT z PCT(%)= PLT×MPV/10 z LYM% = 100 x AL /（AL+AM+AG） z MID% = 100 x AM /（AL+AM+AG） z GRAN% = 100 x AG/（AL+AM+AG） z LYM# = LYM% x WBC/100

z MID# = MID% x WBC/100 z GRAN# = GRN x WBC/100 AL: Number of cells in LYM area;

AM: Number of cells between lymphocyte and granulocyte area;

Chapter 2 HARDWARE

The instrument has the following hardware

CPU Board, CCU Board, cable adapter board, liquid tubing optical conpler optocoupler adapter board, motor optocoupler adapter board, DOM card, LCD adapter board, transformer, recorder Board, switching power supply and inverter.

2.1

CPU BOARD

2.1.1 Function

With CPU as the core, the computer system also includes some peripheral equipments, such as DRAM, SRAM, besides there are some interfaces, such as USB interface, COM2 interface, COM1 interface, LPT printer interface, power supply interface, mouse/keyboard interface, display screen TFT cable interface, peripheral display interface, DOM interface. As the chart 2-1.

The basic components of the computer system are CPU, DRAM, SRAM. They also supplied the basic running environment for software.

2.1.2 Interface

Chart 2-1

8、 DOM card interface 9、 LPT printer interface

6、 Display TFT cable interface

7、 VGA ： external display interface 4、 Mouse interface 5、 Keyboard interface 3、 USB interface 2、 COM2 interface 1、 COM1interface 1 2 3 9 8 4 5 7 6

2.2

CCU BOARD

2.2.1 Function

The CCU board consists of six modules: Digital Circuit

Drive Circuit

Analog/Digital converted Circuit

Analog Circuit

Power Circuit HGB Measurement Circuit

2

3 4 5 7 6

Chart 2-2

Chart 2-3

1. Cpu Interface 2. Power Supply Interface 3 .Step Motor C Sensor And Optocoupler Interface 4. Valve Interface

5. Liquid sensor interface 6. HGB Cable Interface

7. Temperature Sensor Interface. 8. 110v Ignition Voltage Input Interface 9. Probe Electrode Cable Interface 10. Indicator Led Interface

11 Recorder 20pin Flat Cable Interface

2.3

TFT Cable Converting Board

2.3.1 Function

The function of TFT Cable Converting Board is to connect all blocks and CCU board, and to adjust the sensitivity of liquid sensor through adjusting the trimmer on TFT Cable Converting Board.

2.3.2 Interface

8

Motor and optocoupler jack Valve jack

Liquid sensor jack

Adjustable potentiometer Chart 2-4

2.4. LCD adopter

2.4.1. Function

The main function of LCD is to connect screen and CPU with cable and TFT through FPC soft cable. It is used to transmit signal from CPU to display screen. Display as following: chart 2-5.

FPC soft cable socket can contact with screen directly

TFT cable jack (to contact with MTB board ) directly.

2.5 RECORDER BOARD

2.5.1 Function

The main functions of the recorder board are to receive and deal with the printing data, and then transmit the data to thermal printer. At the same time, the recorder board drives the motor to print the received data. It is as the chart

Power supply

int rface e

Record cable interface

Chart 2-6

2.6 DOM card

2.6.1 Function

DOM card is used for deposition. It should make sure the DOM card is in correct way before insert it. As the following chart:

Drawing tablets

Drawing tablets DOM jack

Chapter 3 TUBING

3.1 TUBING GRAPH

3.2

STRUCTURE OF TUBING SYSTEM

3.2.1 Liquid road structure

8、 Glass bulb 9、 Cleaner sensor. 7、 Sample machine. 6、 Dilution block 5、 Waste liquid sensor. 4、 Dilution sensor. 3、 Vacuum pump block. 1、 Vacuum pump machine. 2、 Lyse sensor. 8 6 1 2 3 4 7 Chart 3-2 5 9

3.2.2 Tubing Sensor Unit

The instrument includes four tubing sensor: diluent tubing sensor, rinse tubing sensor, lyse tubing sensor, waste liquid sensor and reagent temperature sensor.

The tubing sensor, rinse tubing sensor, lyse tubing sensor are sued to check if the reagent enters into the tubing system. If there is no reagent in the tube. The instrument will give alarm of “no diluent” or “no cleaner” or “no lyse”.

Waste liquid sensor is used to test if the waste liquid is full. If yes, there instrument will give alarm of “waste liquid full.”

reagent temperature sensor is used to check the reagent temperature in the tube. If the temperature is too low the instrument will give alarm of “temperature too low”.

3.2.3 HGB Unit

This part is used to measure the hemoglobin concentration.

3.2.4 Dilute Unit

This part consists of sample sucker structure and dilution structure. Sample sucker structure is used to aspirate sample, add it into the probe structure and clean the sample needle. Dilution structure is used to provide power to suck sample.

3.2.5 Vacuum Unit

This part is made up of vacuum pump and vacuum decelerating structure.

The vacuum decelerating structure is working under the system software and is used to provide power in the condition of electrifying. Vacuum pump is driven by vacuum decelerating structure and produce negative pressure. So that to provide working power to all this tube system such as waste emissions.

3.2.6 Auxiliary Unit

This part mainly refers to the tubing hose, connecting tube and electromagnetically operated valve.

Chapter 4 SYSTEM STRUCTURE

4.1 DISASSEMBLE/REPLACE PARTS AND COMPONENTS

4.1.1 Disassemble/Replace the Sample Machine

Block

slider

is necessary to replace the sample needle wipe block, seal washer and synchronous driving belt

4.1.2 Disassemble/Replace the Diluent Machine

It

of thesample machine periodically. The replacing cycle is one year.

4.1.4 Disassemble/Replace the Vacuum Pump Block

It is necessary to replace the seal washer of the vacuum pump periodically. The replacing cycle is one year.

4.1.5 Disassemble/Replace the Piston Block

It is necessary to replace the seal washer of the piston block periodically. The replacing cycle is one year.

4.1.6 Disassemble/Replace Chamber

Chapter 5 ADJUSTMENT

This part introduces how to adjust the gain of the passage.

5.1

GENERAL

2800 probe components: RBC, WBC gain, HGB gain. 5.1.2 Replace the Aperture

Aperture: WBC gain, RBC gain 5.1.3 Replace CCU board

Need to adjust the gain of the WBC, RBC/PLT, HGB.

5.2 ADJUST PROGRAM

In main operation window of the instrument, click the right key of the mouse, pops up the menu. Move the cursor to “Calibration/Manual Calibration”. Adjust the calibration factors to 100%. Click the right key of the mouse, and pops up the menu, then move the cursor to “Service/Maintenance”, enter the password “6666”, and click “F12”key.

Click the right key of the mouse, pops up the menu, then move the cursor to “Calibration/Factory Manual Calibration”. Adjust the calibration factors to 100%.

Use the calibration of Procan recommended. In main operation window, measure the calibration. According to the measured histograms to adjust the gain of the passage. Adjust the gain of passage WBC, RBC according to the Multi-Parameter Assayed Hematology Control Expected Results

Sheet.

In main operation window of the instrument, click the right key of the mouse, pops up the menu. then move the cursor to “Service/Test”, enter the password “6800”,click “HGB Background/T” key to adjust the potentiometer VR5,setting the voltage as 4.31±0.02V.

5.3 ADJUST PLACE

1 2

3

1. Adjustment of WBC Gain 2. Adjustment of RBC Gain 3. Adjustment of HGB Gain

Chapter 6 MAINTENANCE

As other precision instrument, only careful daily service and periodic maintenance can the instrument have a good working status, and can we get the reliable measurement results and have less malfunctions. This chapter introduces some preventive methods for service and maintenance. If you want to know more relative information, please contact the customer service department of Procan.

According to the requirements for maintenance of the instrument during the using procedures, we divide the preventive service and maintenance into the following types: daily, weekly, monthly, yearly and maintenance according to actual need.

Warning:

If the hospital or agency don’t perform a satisfying plan to maintain the instrument, there

will be abnormal malfunction.

6.1

ROUTINE MAINTENANCE

6.1.1 Clean the Appearance of the Instrument

Wipe the appearance of the instrument with neutral detergent or distilled water.

Caution:

Avoid using corrosive acids, alkali, and volatile organic solvent such as: acetone, aether,

chloroforms to wipe the appearance of instrument. Only can use the neutral detergent.

Caution:

6.1.2 Replace Fuse

The fuse is installed in the fuse-box on the side of power switch. Open the box to replace the fuse expediently.

Appointed specification fuse:AC250V 2A

Warning:

Only can use the appointed specification fuse.

6.2

DAILY MAINTENANCE

It can be divided into two types: run and shutdown. „ Run

The instrument has installed daily maintenance procedure. On running, it can execute auto cleaning procedure according to the quantity of the sample to keep the instrument in good working status. Set the auto cleaning procedure according to the section 6.3. The general setup principles are:

Working time > 8 hours, auto-cleaning time=8 hours; 4 hours<Working time<8 hours, auto-cleaning time=4 hours;

Working time< 4 hours, auto-cleaning time=2 hours The auto-cleaning time will decrease 1 hour year by year. „ Shutdown

The instrument should be operated by auto maintenance before shut off the instrument. You only need to clean the workbench and wipe the appearance of instrument when the power-off.

6.3

WEEKLY MAINTENANCE

This instrument has installed weekly maintenance procedure. Act as follows: a) Prepare E-Z cleanser and probe cleanser.

In the menu area, select “Service/Maintenance”. Operate as the screen shows. c) Turn off the power supply.

d) Wipe the appearance of instrument as section 6.1.1.

6.4

MONTHLY MAINTENANCE

It is necessary to clean the dust of the instrument monthly. Operate as follows:

a) Turn off the power supply, and pull out the power line. b) Hold up the air filter cover with screwdriver.

Take off the cover and the net. Clean them with neutral detergent brush and put them in the shade.

c) Airing naturally .Brush away the dust clinging on the air filter grid at the rear panel of instrument.

d) Put the air filter grid on the air filter net carefully. Planish them.

Notice:

Only can use the neutral detergent cleaning the air filter. Avoid airing it with heat.

6.5

YEARLY MAINTENANCE

It’s necessary to perform preventive maintenance once every year. Because of the highly-requirements for yearly maintenance, the maintenance should be performed by the authorized engineer of Procan. Please contact the customer service department of Procan before yearly maintenance.

6.6 THE MAINTENANCE BEFORE TRANSPORT OR

FOR

INSTRUMENT THAT WILL NOT BE USED FOR A LONG TIME.

If the instrument is not going to be used in 2 weeks or longer, or need to pack and transport, performing the following procedures:

in the menu.

b) Operate as screen shows.

c) Rotate the bottle covers of rest reagents and store them as the reagent operation introduction. User should perform efficient action to prevent the material from deteriorating, mis-eating and misusing.

d) Plug the stopples which were pulled out at the first installation into the corresponding tube connector.

e) Pull out diluent connection tube, rinse connection tube, lyse connection tube and waste connection tube and clean them with distilled water. Dry them in shady place, then packing them into plastics.

f) Pull out the power wire, packing it in plastics after cleaning with neutral detergent. g) Put the instrument and parts packed in plastics into packing cases.

Chapter 7 TROUBLESHOOTING

7.1 PROGRAM TEST

Test instrument through the following programme:

Blank Test Observe the test data and data gaps is in compliance with technical requirements or not

Sample test The test result is steady or not (CV value is accord with technical

requirement

Blank data does not meet the technical requirements

The amount of data does not meet the technical requirement --- High

Start instruments, observation equipment self-test is normal, all moving parts is running smoothly, and liquid road system without leakage and other abnormalities, apparatus with alarm or not

OK NG OK Sample tests do not meet technical NG END OK Maintenance Start up abnormal

Moving parts run abnormal Liquid road system leakage N Mainten ance Maintenan NG

Make sure the ambient temperature humidity atmospheric pressure are in

Make sure if the reagent is enough, original reagent and not expired

Make sure the voltage is correct to our instrument

Make sure the reagent is connected correct

and reliable

Make sure if any part is connected correctly and reliable.

7.2

CHECKING ITEMS BEFORE MAINTENANCE

Items required for checking before maintenance:

Ambient Temperature: 15～35℃ Temperature of the reagent: 15～30℃ Humidity: 10～90% Atmospheric Pressure: 86.0kPa～106.0kPa

If the temperature is below 15 ,the activity of the reagent will reduce. It will weaken the capacity ℃ of dissolving the blood. In a certain time, it can not break down the red blood cell membranes into 2fl cellular debris. At lower temperature conditions, the red blood cell debris will gather together. It will affect the measurement of leukocyte, resulting in the count value of WBC increasing .It will also affect the measurement of HGB, resulting in the count value of HGB increasing. Checking for Sample Blood

Sample Collection: Observe whether the operator uses correct method to collect the blood

(Operating as PE-6800 FULLY AUTO HEMATOLOGY ANALYZER OPERATION MANUAL /Chapter 3/Section 3.5 Preparation For Sample Collection), and whether the sample is stored in the container filling with EDTA.K2O.H2O anticoagulant.

Sample Storage: After the sample blood is well-mixed, test on the instrument promptly. As time

goes by, the volume and density of the cells will change. The environment and the patient determine the varying rate of the volume and density. If the sample is placed a long time at room temperature, the volume of RBC will increase, and the MCV, RDW, PDW will be affected, and the PLT will easily gather together.

Affection of WBC Classification: To get the exact measuring results, the venous blood sample

measurement must be completed within 4 hours. If the sample blood is placed a long time at room temperature, the total number of WBC may change little, but the classification is inaccurate.

7.3

BACKGROUND CHECK

Background Check: This item can ensure the measurement and the calculated data won’t be

affected by reagent empty. If the background value exceeds the permissive area, the measured and calculated data will be inaccurate.

Parameter Background Range Unit WBC ≤0.2×109/L 109/L RBC ≤0.02×1012_/L 1012/L HGB ≤1g/L g/L HCT ≤0.5％ % PLT ≤10×109/L 109/L

Background Test Method: When power-on, suggested to run background test, you can also

execute background test as you need. The operation steps are as follows:

a) In the blood cell analyzer window, press “Info” button, and pops up the information edit window. Then click the item textbox, change the ID as 999999999.then press “OK”, return to blood cell analyzer window.

b) Background count in venous or capillary mode, press the “START” key below the sample needle directly for background count. In prediluted mode, the sample needle aspirates some non-contaminated diluent from the chamber for background count. The diluent pick-up method as follows(Analyzing the sample in prediluted mode, it is also necessary to dilute sample with the diluent which is prior picked-up in this method):

In main operation area, press the right key of the mouse, pops up the menu. In menu operation area, select “Sample Mode/ Prediluted” to set the sample mode as prediluted mode.

In main operation area, press the right key of the mouse, pops up the menu. In the menu operation area, select “Diluent”. Place a clean empty chamber or tube under the sample needle, press “START” key to dispense the diluent into the chamber. Press the “START” key once, the diluent

is dispensed into the chamber or tube once (The quantity can be used for background count in the second prediluted mode).

Press “Exit” button to return to the main operation area. Affected Factors of Background:

1、 The reagent is dirty. 2、 The chamber is dirty.

3、 Electronic interference affects measurement and the calculated circuit, for example: Interference created by voltage fluctuation, peripheral equipment such as centrifugal

machine, CT machine, magnetic resonance device, etc. 4、 Tubing Contamination

Chapter 8 Appendix 1 Lead label

No. Stick place Label name note

1 Motor A MA Sample structure monitor in the kickstand place

2 Motor B MB Sample structure monitor in horizontal axis fixed plate 3 Motor C MC Dilution monitor 4 Motor D MD Vacuum decelerating monitor 5 Optocoupler A OSA Sample structure switch in the

kickstand place

6 Optocoupler B OSB Sample structure switch in horizontal axis fixed plate 7 Optocoupler C OSC Dilution switch 8 Optocoupler D OSD Vacuum decelerating switch 9 Dilute sensor DLS

10 Lyse sensor LYS 11 Cleaner sensor CLS 12 Waste liquid

sensor WST 13 switch STA 14 MTB board MTB

15 valve V1.V2…V16 The lead is according to the No. of valve

Chapter 9 Appendix 2 Debug record form

Name : Host debugging technics No: F-6807-30-02301 Edition： Serial No. of product： Temperature： Humidity：

Item Requirement Result Note

appearance According to the requirement of standard products † OK † Not ok. fitting Refer to PE-6807 the requirement of “host production

requirement”

† OK † Not ok. Display screen Should display full screen and every label should

clear and no color cast

† OK † Not ok. Mouse interface Check the connection between jack and mouse is

connected well and can work in good way.

† OK † Not ok. Keyboard interface Check the connection between jack and keyboard is

connected well and can work in good way.

† OK † Not ok. Indicator light It will light when standby and shine when suck

sample.

† OK † Not ok.

Reagent alarm With words and sound alarm † OK

† Not ok. Backboard fan With right direction and without noice cacophony † OK

† Not ok.

Date and time Local date and time † OK

† Not ok. valve With correct place and there is sound when connected

with electricity.

† OK † Not ok. Data circuit It will display “ok” when we check it. † OK

† Not ok.

HGB black voltage Adjust to 4.31V V

Burning function Chamber have sound of “ Chichi”. The indicator light will be on. † OK † Not ok. Motor and associated moving parts

Smooth operation, no abnormal sound, non-blocking phenomenon

And the status of the test results should be "OK"

† OK † Not ok. Sampling needle tip

position

perpendicular to the direction of origin

Adjust the position with the sampling needle position tool

† OK † Not ok. Negative pressure of

vacuum chamber 79.2±1 KPa KPa

Vacuum chamber

leak rate ≤0.2 KPa /2Min KPa /2Mins

Reagent temperature test

Temperature of thermometer should be ±5℃ the

same as temperature inside of chamber ℃

Click up Aperture

voltage

9～20V V Aperture voltage test

Click down Aperture

voltage

Less than3V V

Draining the amount

of pre-diluted mode 8.0±0.4ml ml

Test the voltage of liquid sensor is 3.0V～5.0V with

reagent V

Test the voltage of

liquid sensor Test the voltage of liquid sensor is ≤1.5V without

reagent V

Air Mixer There is air bubble come out from bottom of cup. † OK † Not ok. The ability of

chamber shield (cover) and the substrate insulation

Resistance should be more than 20MΩ † OK † Not ok. Lymphocyte peak _fL Channel gain RBC peak fL WBC ≤0.2×109/L 0×109/L RBC ≤0.02×1012/L 0×1012/L HGB ≤1g/L 0g/L HCT ≤0.5％ 0％

Take count in blank

PLT ≤10×109_{/L 0×10}9_/L † OK † Not ok The average of blank test result

Oversee the time of

blank counting 12S+1S □ OK □ Not ok The average value of 5 times counting time WBC V

Set the Reference voltage value of pinAperture RBC V Every time of blank test is ok.

Add liquid cleaning kits

The liquid should flow cling to the needle uniformly and there is no departure of needle and no share phenomenon

□ OK □ Not ok.

WBC ≤200KB

Channel data volume

RBC ≤100KB

† OK † Not ok.

Any one blank test

PLT ≤300KB result WBC ≤0.5％ RBC ≤0.5% HGB ≤0.5% Carrying contamination test PLT ≤1.0% † OK † Not ok. WBC RBC HGB MCV Venous and Periphera l blood calibratio n paramete r PLT † OK † Not ok. WBC RBC HGB MCV Instrument calibration Pre dilute calibration parameter PLT † OK † Not ok. WBC accuracy test ≤3.0% RBC accuracy test ≤3.0% HGB accuracy test ≤3.0% MCV accuracy test ≤1.0% Accuracy test（CV） PLT accuracy test ≤7.0% † OK † Not ok. Venous blood model Predilution model WBC accuracy error range ± 6% RBC accuracy error range ± 5% HGB accuracy error range ± 4% MCV accuracy error range ± 5% Test accuracy PLT accuracy error range ± 14% † OK † Not ok.

Record and alarm

Printing characters, graphics should be correct, clear. The functioning of institutions should be smooth. There is no abnormal sound, no paper block but with alarm function phenomenon, there are alarm.

□ OK □ Not ok.

Pinter and net function

Printing characters, graphics should be correct, clear.Meanwhile the PC can accept complete and correct data and graphic.

□OK □Not ok. WAperture

Chapter 10 Appendix 3 TROUBLESHOOTING

Error Message

Possible Reason

Troubleshooting

Fluctuating input AC voltage Use stabilized voltage power supply Fuse burn-out

Power supply board is short circuit Replace new power supply board There are bubbles in chamber Exclude the bubbles

The reagent is inadequate Re-prime the reagent The setup of count time is too long Reset the count time The aperture is broken Renew the aperture

The count passage leaks Replace the leakage count tubing Bubbles

The back cover and body of chamber lacks Replace the the back cover of sample cover

The reagent is contaminated Renew the reagent Electronic interference Connect the ground wire Abnormal

background test

Tubing contamination Clean the tubing There are large-cells or debris in the

sample

Remove the debris from the sample

The setup of count time is too short Reset the count time

Aperture clogs Clean the aperture

Inadequate diluent Check for diluent and piston block Clogs

MTB is broken Replace MTB board

Incorrect connection of the signal line Re-connect the signal line Unclear display

Liquid crystal display screen is aging Replace the display screen

The WBC chamber is dirty , Dip in the chamber ,or adjust the gain of HGB

The battery is not get enough light Replace battery or WBC probe components

Abnormal HGB background

voltage

LBD Is Not Light Enough Replace the LBD or WBC probe components

Some keys of the keyboard is irresponsive

The CPU board or the keyboard is broken Replace the CPU board or the keyboard

Abnormal vacuum chamber pressure Replace vacuum chamber Liquid leaks

The waste tubing is obstructed Dredge the waste tubing

The sample is placed a too long time Measure the sample within 30 minutes

Abnormal

mid-sized cell

percentage The anticoagulant is superfluous Reduce the quantity of anticoagulant.

Reagent is used up Renew the diluent

Fluid hose seal in bad way Check the connection and get rid of liquid lack

The piston block leaks Replace the piston block or seal ring No reagent,

Rinse(diluent/lyse)

empty alarm _{The rinse(diluent/lyse) sensor is broken ,or} the connector is broken off

Replace the rinse(diluent/lyse) sensor

The chamber is dirty Clean the chamber The count time is longer than setup time Reset the count time One sensor of the MTB board is broken Replace MTB board WBC/ RBC clogs

The reference voltage of Aperture is much lower than the actual test values

Reset the reference voltage of Aperture

There are problems on CCU board Replace or repair CCU board There is no result

of RBC, WBC measurement

The electrode cable is broken Replace or repair probe components

The instrument is effected by high electromagnetic machine. Such as the instrument is not connected well with ground

Get rid of the electromagnetic machine.

The liquid road is dirty Clean the liquid road and operate maintenance programme. The result of RBC,

WBC is high