PE-6800 FULLY AUTO HEMATOLOGY ANALYZER SERVICE MANUAL
Procan Electronics Inc. 5/F., 4thBldg.,NO.2, Gaoxin C. 1st Ave., High-tech Industrial Park, Nanshan,Shenzhen 518057, P.R. China Tel: (+86) 755 26516667, 26952867 Fax: (+86) 755 26747910
Contents
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
DETECTION PRINCIPL ......................................................................................................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
CPU BOARD.........................................................................................................................16
2.1.1
Function...............................................................................................................................16
2.1.2
Interface...............................................................................................................................17
2.2
CCU BOARD ........................................................................................................................17
2.2.1
Function...............................................................................................................................17
2.2.2
Front Interface .....................................................................................................................17
2.3
TFT CABLE CONVERTING BOARD ..........................................................................................19
2.3.1
Function...............................................................................................................................19
2.3.2
Interface...............................................................................................................................19
2.4. LCD ADOPTER ..............................................................................................................................20 2.4.1. Function ....................................................................................................................................20 2.5 RECORDER BOARD ..................................................................................................................21 2.5.1 Function .....................................................................................................................................21 2.6 DOM CARD ...................................................................................................................................21 2.6.1 Function .....................................................................................................................................21 CHAPTER 3 TUBING...................................................................................................................... 22 3.1 TUBING GRAPH.........................................................................................................................22 3.2
STRUCTURE OF TUBING SYSTEM ..................................................................................23
3.2.1 Liquid road structure..................................................................................................................23 3.2.2
Tubing Sensor Unit..............................................................................................................23
3.2.3
HGB Unit.............................................................................................................................24
3.2.4
Dilute Unit ...........................................................................................................................24 T- 6807-30-02357
V1.0
I
Contents 3.2.5
Vacuum Unit ........................................................................................................................24
3.2.6
Auxiliary Unit......................................................................................................................24
CHAPTER 4 SYSTEM STRUCTURE............................................................................................ 25 4.1 DISASSEMBLE/REPLACE PARTS AND COMPONENTS.......................................................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
ADJUST PROGRAM ............................................................................................................31
5.3
ADJUST PLACE ...................................................................................................................32
CHAPTER 6 MAINTENANCE ....................................................................................................... 33 6.1
ROUTINE MAINTENANCE................................................................................................33
6.1.1
Clean the Appearance of the Instrument..............................................................................33
6.1.2
Replace Fuse........................................................................................................................34
6.2
DAILY MAINTENANCE .....................................................................................................34
6.3
WEEKLY MAINTENANCE .................................................................................................34
6.4
MONTHLY MAINTENANCE ..............................................................................................35
6.5
YEARLY MAINTENANCE..................................................................................................35
6.6 THE MAINTENANCE BEFORE TRANSPORT OR FOR
INSTRUMENT THAT
WILL NOT BE USED FOR A LONG TIME. .....................................................................................35 CHAPTER 7
TROUBLESHOOTING .......................................................................................... 37
7.1 PROGRAM TEST ........................................................................................................................37 7.2
CHECKING ITEMS BEFORE MAINTENANCE ................................................................38
7.3
BACKGROUND CHECK.....................................................................................................38
CHAPTER 8 APPENDIX 1 LEAD LABEL....................................................................................... 41 CHAPTER 9 APPENDIX 2 DEBUG RECORD FORM .................................................................. 42 CHAPTER 10 APPENDIX 3 TROUBLESHOOTING ..................................................................... 45
II
T- 6807-30-02357
V1.0
Instrument Introduction
Chapter 1 1.1
INSTRUMENT INTRODUCTION
STRUCTURE
Host and accessory.
1.1.1
Host
Control the process of sample collection, dilution and analysis, including the following units: Hematology analyzer
Former cover parts
RBC chamber
CCU board
Vacuum pump machine
Dilution machine
CPU Board
System software
Vacuum pump block
Power supply
Dilution block
Sample machine
1.1.2
WBC chamber
TFT cable
Glass bulb
Adapter PCBA
Switch parts
Backboard parts
Transformer
Liquid tubing
Liquid Sensor
Accessory
Including the following accessories: 1. PS/2 mouse. PS/2 keyboard. 2. Diluent cap components, washing liquid cap components, hemolytic agent cap components, 1
Instrument Introduction 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 Table 1-1
2
Instrument Introduction
1.3
SPECIFICATIONS
Standard Classification of the Instrument 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.
Principles of Measurement Blood Cells are counted and sized by Electrical Impedance Method. Hemoglobin is determined by Colorimetry Method.
Parameters of Measurement
Basic parameters: 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%
%
Granulocyte percentage
GRAN%
%
3
Instrument Introduction Mean Corpuscular(erythrocyte) Volume
MCV
fL
Red Blood Cell Distribution Width Standard
RDW-SD
fL
RDW-CV
%
Mean Platelet Volume
MPV
fL
Platelet Distribution Width
PDW
%
Plateletcrit-large Cell Ratio
P-LCR
%
Deviation Red Blood Cell(erythrocyte) Distribution Width Coefficient of Variation
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
%
Sampling Features: Venous and Capillary Blood Mode:
Prediluted Mode:
WBC/HGB RBC/PLT
1:44600
WBC/HGB
1:355
RBC/PLT
1:44500
Cell Counting Aperture Size: WBC/RBC:
80μm
Display Liquid Crystal Display (LCD),resolution:640×480
4
Language
1:300
Instrument Introduction 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.
Take electrode cable from CCU board and use the two pens of multimeter (which 5
Instrument Introduction 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 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:
Parameter
50.0kPa ~106.0kPa
Electric Specifications Power Supply:
AC 100-240V,
50±1Hz,
The maximum input consumption is 150VA Fuse:
6
AC 250V
2A
Instrument Introduction
Dimensions and Weight Dimensions:
394mm×381mm×500mm
Weight:
23kg
1.4
STRUCTURE
1.4.1
Front Panel
1
5
4
3
2
Figure 1-1 1. Power Light
2. [START] Key
3. Sample Needle
4.Display Screen
5. Thermal Recorder
1.4.2
Rear panel
7
Instrument Introduction
（9）
（5） （4）
（6） （2） （7） （3）
（8）
（1）
（18）
（17）
（16）
（15）
（14） （13）
（12）
（11）（10）
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
8
Instrument Introduction
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
INFORMATION
SECTION
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 9
Instrument Introduction 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 Manual Calibration: Enter the manual calibration window to calibrate the instrument manually. 10
Instrument Introduction 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. Mechainc: Enter the Mechainc window to verify the functions of the instrument. 11
Instrument Introduction 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.
12
Instrument Introduction
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 MID
35～90 fL 90～160 fL 13
Instrument Introduction GRAN
1.6.4
160～450 fL
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 %.
14
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
Instrument Introduction 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; AG: Number of cells in GRAN area.
15
Hardware
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.
16
Hardware
2.1.2
Interface
1
1、 COM1interface 2、 COM2 interface 3、 USB interface
2
4、 Mouse interface 3
5、 Keyboard interface 6、 Display
TFT
cable
interface 7、 VGA ： external display interface 4 5
8、 DOM card interface 9、 LPT printer interface
6 7
8
9
Chart 2-1
2.2
CCU BOARD
2.2.1
Function
The CCU board consists of six modules: Digital Circuit Drive Circuit Power Circuit
2.2.2
Analog/Digital converted
Analog Circuit
Circuit HGB Measurement Circuit
Front Interface
17
Hardware 1
2
3
4
5 Chart 2-2
18
7
6
Hardware 10
11
8
9
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
19
Hardware
Liquid sensor jack
Adjustable potentiometer
Valve jack
Motor and optocoupler jack
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. Chart 2-5
20
Hardware
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 interface
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
DOM jack
Drawing tablets
Chart 2-7
21
Tubing
Chapter 3
TUBING
3.1 TUBING GRAPH
Chart 3-1
22
Tubing
3.2
STRUCTURE OF TUBING SYSTEM
3.2.1 Liquid road structure 1、 Vacuum pump machine. 2、 Lyse sensor.
8
6
3、 Vacuum pump block.
1 7
2 4
4、 Dilution sensor. 5、 Waste liquid sensor. 6、 Dilution block
3
7、 Sample machine. 8、 Glass bulb 9、 Cleaner sensor.
9
3.2.2
5
Chart 3-2
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”.
23
Tubing
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.
24
System Structure
Chapter 4
SYSTEM STRUCTURE
4.1 DISASSEMBLE/REPLACE PARTS AND COMPONENTS 4.1.1 Disassemble/Replace the Sample Machine Block
slider
Chart 4-1 25
System Structure
It is necessary to replace the sample needle wipe block, seal washer and synchronous driving belt of the sample machine periodically. The replacing cycle is one year.
4.1.2
Disassemble/Replace the Diluent Machine
4.1.3
Disassemble/Replace the Vacuum Block
26
System Structure
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.
27
System Structure
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.
28
System Structure
4.1.6
Disassemble/Replace Chamber
Chart 4-6
29
System Structure
Chart 4-7
30
Adjustment
Chapter 5 ADJUSTMENT This part introduces how to adjust the gain of the passage.
5.1
GENERAL
5.1.1
Replace the chamber
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 5.2.1 Adjust calibration parameter. 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.
31
Appendix 2 Debug record form
5.3 ADJUST PLACE
12
3
1. Adjustment of WBC Gain 3. Adjustment of HGB Gain
32
2. Adjustment of RBC Gain
Maintenance
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: Avoid wiping the inner of the instrument.
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Maintenance
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: AC 250V 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, execute auto cleaning
it can
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
6.3
WEEKLY MAINTENANCE This instrument has installed weekly maintenance procedure. Act as follows: a) Prepare E-Z cleanser and probe cleanser. b) In the main operation window, press the right key of the mouse, pops up the menu.
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Maintenance 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: a)
In the main operation window, press the right key of the mouse, choose “Service/Park”
35
Maintenance 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.
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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.
Troubleshooting
Chapter 7
TROUBLESHOOTING
7.1 PROGRAM TEST Test instrument through the following programme:
Make sure the ambient temperature humidity atmospheric pressure are in
Start
instruments,
observation self-test
Start up abnormal
equipment
is
normal,
moving parts is running
NG
Moving parts run abnormal
smoothly, and liquid road system without leakage and other
N
abnormalities,
Liquid road system leakage
apparatus with alarm or not
Make sure if the reagent is enough, original reagent and not expired
OK
Blank
Blank data does not meet the technical requirements
Test
Observe the test
Make sure the voltage is correct to our instrument
Mainten ance
all
data and data gaps is in compliance with
The amount of data
technical
requirements
Maintenan
NG
does
or
not
technical
not
meet
the
requirement
--- High
OK Make sure the reagent is connected correct and reliable
Sample test The test result is steady or not (CV value is accord with
NG
Sample tests do not meet technical
Maintenance
technical
Make sure if any part is connected correctly and reliable.
requirement
OK END
Chart 7-1
37
Troubleshooting
7.2
CHECKING ITEMS BEFORE MAINTENANCE
Items required for checking before maintenance: Ambient Temperature:
15～35℃
Temperature of the reagent: 15～30℃ Humidity: Atmospheric Pressure:
10～90% 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. The permissive range of the background test results is 38
Troubleshooting
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.
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Troubleshooting 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、
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Tubing Contamination
Lead label
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
41
Debug record form
Chapter 9 Appendix 2 Debug record form Name : Host debugging technics Serial No. of product： Item
No: F-6807-30-02301 Temperature：
Edition： Humidity：
Requirement
Result
OK
Not ok.
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.
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.
OK Not ok. V
appearance
According to the requirement of standard products
fitting
Backboard fan
Data circuit
It will display “ok” when we check it.
HGB black voltage
Adjust to 4.31V
Burning function
Chamber have sound of “ Chichi”. The indicator light will be on.
OK Not ok.
Motor associated parts
Smooth operation, no abnormal sound, non-blocking phenomenon And the status of the test results should be "OK"
OK Not ok.
OK
Not ok.
and moving
Sampling needle tip position perpendicular to the direction of origin
Adjust the position with the sampling needle position tool
Negative pressure of vacuum chamber
79.2±1 KPa
Vacuum leak rate
≤0.2 KPa /2Min
chamber
5.0V voltage test
42
5.00±0.5V
KPa KPa /2Mins V
Note
Debug record form Reagent temperature test
Aperture voltage test
Draining the amount of pre-diluted mode Test the voltage of liquid sensor
Air Mixer The ability of chamber shield (cover) and the substrate insulation
Temperature of thermometer should be ±5℃ the same as temperature inside of chamber Click Aperture voltage
V
Less than3V
V
ml
Test the voltage of liquid sensor is 3.0V～5.0V with reagent
V
Test the voltage of liquid sensor is ≤1.5V without reagent
V
There is air bubble come out from bottom of cup.
Resistance should be more than 20MΩ
OK Not ok.
OK Not ok.
Lymphocyte peak
fL
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％
Oversee the time of blank counting
OK Not ok
0％ 9
≤10×10 /L
0×109/L
□ □
12S+1S
Set the Reference voltage value of pinAperture
Channel data volume
9～20V
8.0±0.4ml
PLT
Add liquid cleaning kits
up
Click down Aperture voltage
Channel gain
Take count in blank
℃
OK Not ok
WBC
V
RBC
V
The liquid should flow cling to the needle uniformly and there is no departure of needle and no share phenomenon
The average of blank test result The average value of 5 times counting time Every time of blank test is ok.
□ OK □ Not ok.
WBC
≤200KB
OK
RBC
≤100KB
Not ok.
Any blank 43
one test
Debug record form
Carrying contamination test
Instrument calibration
PLT
≤300KB
WBC
≤0.5％
RBC
≤0.5%
OK
HGB
≤0.5%
Not ok.
PLT Venous and Periphera l blood calibratio n paramete r
≤1.0% WBC RBC HGB MCV
OK Not ok.
OK Not ok.
Pre dilute calibration parameter
Accuracy test（CV）
Test accuracy
result
PLT WBC RBC HGB MCV PLT
WBC accuracy test
≤3.0%
RBC accuracy test
≤3.0%
HGB accuracy test
≤3.0%
MCV accuracy test
≤1.0%
PLT accuracy test
≤7.0%
WBC accuracy error range
± 6%
RBC accuracy error range
± 5%
HGB accuracy error range
± 4%
MCV accuracy error range
± 5%
PLT accuracy error range
± 14%
OK Not ok.
Venous blood
Predilution
model
model
OK Not ok.
Printing characters, graphics should be correct, clear. The Record and alarm
functioning of institutions should be smooth. There is no abnormal sound, no paper block but with alarm function phenomenon, there
□ OK □ Not ok.
are alarm. Pinter and net function WAperture estimation.
44
Printing characters, graphics should be correct, clear.Meanwhile the PC can accept complete and correct data and graphic. □OK
□ Not ok.
□OK □Not ok.
Troubleshooting
Chapter 10 Appendix 3 TROUBLESHOOTING Error Message Fuse burn-out
Possible Reason
Troubleshooting
Fluctuating input AC voltage
Use stabilized voltage power
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
The back cover and body of chamber lacks
Replace the the back cover of sample cover
Abnormal
The reagent is contaminated
Renew the reagent
background test
Electronic interference
Connect the ground wire
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
MTB is broken
Replace MTB board
Incorrect connection of the signal line
Re-connect the signal line
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
LBD Is Not Light Enough
Replace the LBD or WBC probe components
The CPU board or the keyboard is broken
Replace the CPU board or the keyboard
Bubbles
Clogs
Unclear display
Abnormal
HGB
background voltage
Some keys of the keyboard is irresponsive
supply
45
Troubleshooting
Liquid leaks
Abnormal vacuum chamber pressure
Replace vacuum chamber
The waste tubing is obstructed
Dredge the waste tubing
The sample is placed a too long time
Measure minutes
The anticoagulant is superfluous
Reduce the quantity of anticoagulant.
Reagent is used up
Renew the diluent
No reagent,
Fluid hose seal in bad way
Rinse(diluent/lyse)
Check the connection and get rid of liquid lack
The piston block leaks
Replace the piston block or seal ring
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
The reference voltage of Aperture is much lower than the actual test values
Reset the Aperture
There is no result
There are problems on CCU board
Replace or repair CCU board
of
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.
Abnormal mid-sized percentage
cell
WBC/ RBC clogs
RBC,
WBC
the
sample
reference
within
voltage
30
of
measurement
The result of RBC, WBC is high
The sample is stared too long time
46
Get new samples.
