PE-6100

FULLY AUTO HEMATOLOGY ANALYZER

SERVICE MANUAL

Shenzhen Prokan Electronics Inc.

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................................................................................................................... 2
1.4 STRUCTURE............................................................................................................................ 8
1.4.1 Front Panel............................................................................................................................. 8
1.4.2 Rear panel...............................................................................................................................8
1.5 OPERATION............................................................................................................................. 9
1.5.1 Display Screen........................................................................................................................ 9
1.5.2 Menu..................................................................................................................................... 10
1.6 DETECTION PRINCIPLE.................................................................................................... 10
1.6.1 Detection Principles of WBC, RBC, PLT..............................................................................17
1.6.2 Principles of HGB Measurement.......................................................................................... 18
1.6.3 Volume Distribution of Blood Cell........................................................................................19
1.6.4 Results and Calculation of Parameter Measurement........................................................... 19

CHAPTER 2 HARDWARE.......................................................................................................................................................... 21

2.1 CPU BOARD........................................................................................................................... 21

2.1.1 Function................................................................................................................................ 21
2.1.2 Interface .............................................................................................................................. 21
2.2 CCU BOARD...........................................................................................................................22
2.2.1 Function................................................................................................................................ 22
2.2.2 Front Interface...................................................................................................................... 23
2.3 TFT CABLE CONVERTING BOARD.......................................................................................... 25
2.3.1 Function................................................................................................................................ 25
2.3.2 Interface................................................................................................................................ 25
2.4 LCD ADOPTER................................................................................................................................ 25
2.4.1 Function................................................................................................................................... 25
2.5 RECORDER BOARD................................................................................................................... 25
2.5.1 Function................................................................................................................................. 25

CHAPTER 3 TUBING SYSTEM.................................................................................................................................................27

3.1 TUBING DRAWING............................................................................................................................27

3.2 STRUCTURE OF TUBING SYSTEM..................................................................................29
3.2.1 Liquid path structure.............................................................................................................. 29
3.2.2 Tubing Sensor Unit............................................................................................................... 30
3.2.3 HGB Unit.............................................................................................................................. 30
3.2.4 Dilute Unit............................................................................................................................ 30
3.2.5 Vacuum Unit..........................................................................................................................30
3.2.6 Auxiliary Unit....................................................................................................................... 30

CHAPTER 4 SYSTEM STRUCTURE........................................................................................................................................ 31

4.1 DISASSEMBLE/REPLACE PARTS AND COMPONENTS....................................................31

4.1.1 Disassemble/Replace the Sample mechanism........................................................................ 31

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4.1.2 Disassemble/Replace the Diluents Machine.........................................................................32
4.1.3 Disassemble/Replace the Vacuum Block...............................................................................32
4.1.4 Disassemble/Replace the Vacuum Pump Block.................................................................... 33
4.1.5 Disassemble/Replace the Piston Block................................................................................. 33
4.1.6 Disassemble/Replace Sample Cup........................................................................................34

CHAPTER 5 ADJUSTMENT.......................................................................................................................................................35

5.1 GENERAL............................................................................................................................... 35
5.2 ADJUST PROGRAM............................................................................................................. 35
5.3 CCU BOARD LAYOUT.............................................................................................................. 35

CHAPTER 6 MAINTENANCE................................................................................................................................................... 36

6.1 ROUTINE MAINTENANCE.................................................................................................36

6.1.1 Clean the Appearance of the Instrument.............................................................................. 36
6.1.2 Replace Fuse.........................................................................................................................37
6.2 DAILY MAINTENANCE.......................................................................................................37
6.3 WEEKLY MAINTENANCE..................................................................................................37
6.4 MONTHLY MAINTENANCE...............................................................................................37
6.5 YEARLY MAINTENANCE................................................................................................... 38
6.6 THE MAINTENANCE BEFORE TRANSPORT OR LONG TIME NO USE....................... 38

CHAPTER 7 TROUBLESHOOTING.........................................................................................................................................39

7.1 TROUBLESHOOTING AS BELOW FLOW....................................................................................................................... 39

7.2 CHECKING ITEMS BEFORE MAINTENANCE..............................................................40

7.3 BACKGROUND CHECK...................................................................................................... 40

CHAPTER 8 APPENDIX 1: LABEL MARK............................................................................................................................. 42

CHAPTER 9 APPENDIX 2 DEBUG RECORD FORM............................................................................................................43

CHAPTER 10 APPENDIX 3 TROUBLESHOOTING........................................................................... 47

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 Instrument Introduction

Chapter 1 INSTRUMENT INTRODUCTION

1.1 STRUCTURE

Host and accessory.

1.1.1 Host

Control the process of sample collection, dilution and analysis, including the following units:

1.1.2 Accessory

Including the following accessories:

1. USB mouse x1 . USB keyboard x1

2. Diluents cap components, washing liquid cap components, hemolytic agent cap components, waste cap components;

3. RS232 Communication cable x1;

4. Waste barrelx1pc

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

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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
RDW-CV %
Coefficient of Variation
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

1.3 SPECIFICATIONS

 Standard Classification of the Instrument

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

According to the defense 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

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flammable anesthetic gas and air or gas mixture of oxygen and nitrous oxide.

According to working status: Continuous Running Equipment.

 Design Life cycle:

8 years.

 Principles of Measurement

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

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

Calculated from Histograms:

Item Abbreviation Unit

Lymphocyte percentage LYM% %

Mid-sized cell percentage MID% %

Granulocyte percentage GRAN% %

Mean Corpuscular(erythrocyte) Volume MCV fL

Red Blood Cell Distribution Width Standard RDW-SD fL

Deviation

Red Blood Cell(erythrocyte) Distribution RDW-CV %

Width Coefficient of Variation

Mean Platelet Volume MPV fL

Platelet Distribution Width PDW %

Plateletcrit-large Cell Ratio P-LCR %

Calculated Parameters:

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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:

Sample Volume:

Venous Blood Mode: 9.6μL Venous Blood

Capillary Blood Mode: 9.6μL Capillary Blood

Pre-diluted Mode: 20μL Capillary Blood

Reagent Volumes Required for Single Sample:

Diluents: 20.2mL

Rinse: 5.2mL

Lyse: 0.5mL

Venous and Capillary Blood Mode: WBC/HGB 1:300

RBC/PLT 1:44600

Pre-diluted Mode: WBC/HGB 1:355

RBC/PLT 1:44500

Cell Counting Aperture Size:

WBC: 100μm

RBC: 70μm

 Display

Liquid Crystal Display (LCD),resolution: 800×600

 Language

English

 Indicator

20 Parameters and 3 Histograms Display

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Alarm Indicator

Working Status (including Power Supply) Indicator Light

Alarm

 Interface

AC power input socketx1 VGA display port x1 One RS-232 serial ports

USB interfaces x 4pcs Ethernet port x 1pc

Recorder

Rapid Thermal Recorder

Recording width: 48mm

Paper width: 57.5mm

 Blank test
Parameter Test data range Data range
WBC ≤0.2×10 /L
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≤200KB
RBC ≤0.02×10 /L
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≤100KB
PLT ≤10×10 /L9
≤300KB

 Carry Pollution
Parameter Pollution range
WBC ≤0.5％
RBC ≤0.5%
HGB ≤0.5%
PLT ≤1.0%

 Repeatability
Parameter Repeatability (CV %)
WBC ≤2.5%
RBC ≤2.0%
HGB ≤1.5%
MCV ≤0.5%
PLT ≤5.5%

 Accuracy
Parameter Accuracy range

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WBC ±6％
RBC ±5%
HGB ±4%
MCV ±5%
PLT ±14%

 Linear Range
Parameter Linear Range
WBC 0.0-99.9x109/L
RBC 0.00-9.99x1012/L
HGB 0-300g/L
MCV 40 - 150fL
PLT 100-300x109/L

 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

 Hole voltage reference value

WBC hole voltage reference value：the 5 times average W.H.V.S value of blank test

RBC hole voltage reference value：the 5 times average R.H.V.S value of blank test.

 Hole voltage
WBC voltage range 9-19V
Press T1
RBC voltage range 11-23V
WBC voltage range less than 3V
Press T2
RBC voltage range less than 3V

 Sample cup shield and substrate Insulation.

Take electrode cable from CCU board and use the two pens of multi-meter (which have been set the resistance value)

to measure the Sample cup shield and substrate Insulation. The value should be more than 20MΩ。When you finish

test, plug back the electrode cable back. The value should less than 1Ω。

 Reagent temperature

Reagent temperature should be thermometer measured temperature of the sample cup dilution ± 5 ℃.

 Screen Display and the Ranges for Report Output Parameters

Parameter Parameter Range Parameter Parameter Range

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 Instrument Introduction
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 - 99.9fL

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 T3.15AL 250V

 Dimensions and Weight

Dimensions: 325mm×380mm×430mm

Weight: 23kg

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1.4 STRUCTURE

1.4.1 Front Panel

1.4.2 Rear panel

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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:

Figure 1-3

 SYSTEM TIME and SPEAKER SECTION

Display the current date and time of the system, SPEAKER STATUS

 TIPS SECTION :

Display prompt information of the system.

 FUNCTION TAB:

Display various function tab

 MAIN DISPLAY WINDOW:

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 Instrument Introduction
Display various analyzing results

 AUXILIARY OPERATION SECTION

Display the information of user and sample

1.5.2 Menu

User can access all function of analyzer by move mouse cursor or finger tip above button, then click or finger push. Click
<Back> button to quit
For Main UI

Enter Function tab

Input sample and patient information for next sample

Access histogram adjust window for current sample,

Under Venous and Capillary mode, this button can prime diluents into tube.
Under pre-diluted mode, adding diluents

Printout result to printer

Select sample test mode from Venous, Capillary, Pre-diluent

For Function page

Back to upper level of UI

User can review analysis record in detail, edit, delete, inquiry, print,etc

L-J QC control: Enter L-J QC function tab

Calibrate the analyzer

Service, enter service function page

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 Instrument Introduction

Setting, enter setting function tab

Shutdown the machine

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 Instrument Introduction
Review function page

View the samples

Back to upper level

Review selected record in detail

Delete selected record

Find record with input condition

Select record in range with input start and end

Print out selected record

Access more button

Back to upper level

Export select record

Button position is reserved by developer

Button position is reserved by developer

Button position is reserved by developer

CV%：Enter CV% calculation

Access more button

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 Instrument Introduction
L-J QC function page

Enter L-J QC

Edit QC parameter

Select QC file to analysis and to run

View L-J QC in chart

View L-J QC in list

Calibration function page

Calibrate the unit

Back to upper level

Manual calibration

Auto calibration

Access more button

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 Instrument Introduction
Service function page

Enter service interface

Back to upper level

Running maintenance process for analyzer

Self-Detection for PCBA, valve, interface

（Only available under factory mode）

View analyzer information

Upgrade analyzer software via USB or network

View help file

Access more button

Back to upper level

Reagents supply management

Button position is reserved by developer

Button position is reserved by developer

Button position is reserved by developer

Touch-screen calibrate

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 Instrument Introduction

Access more button

Back to upper level

Perform aging test for the machine

Review the pulse graph for the latest test

Restore factory default

Button position is reserved by developer

Button position is reserved by developer

Access more button

Other buttons

Clean general clog

Enhanced clean clog

Normal clean analyzer

Enhanced clean analyzer

Click to prime diluents

Click to prime lyse

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 Instrument Introduction

Click to prime cleaner

Running maintenance process for analyzer

Drain the liquid out of chamber

Reset all step-motor to original position

Running park process, suit for long-time no use or transportation

Enter setting function page

Enter setting function page

Back to upper level

Set reference range

Set date/time

Set interval for auto-clean

Set interval for auto-maintenance

Set interval for auto-sleep while idle

Access more button

Back to upper level

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 Instrument Introduction

Print out selected record

Entering communication setting

Set lab and hospital information

Setting information for doctor and sender

Set gain for the signal processing

Access more button

Back to upper level

User and security management

Button position is reserved by developer

Button position is reserved by developer

UI system Language selection

Set Reference unit for analyzer

Access more button

1.6 DETECTION PRINCIPLE

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
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 Instrument Introduction
passing through an aperture sensor.

a) The sample blood is diluted in a conductive liquid. As blood cells are non-conductive, the diluents is a good conductor.

There are big differences between them.

b) When the diluents 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 diluents and the sample，the concentration of the sample hemoglobin is calculated.
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 Instrument Introduction
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:

W BC 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:

 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.

 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.

 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.

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

the PLT populations.

 P-LCR derives from the PLT histogram. It represents the ratio of the larger PLT and the unit is %.

 HCT(%)= RBC×MCV/10

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 Instrument Introduction
 MCH(pg)= 10×HGB/RBC

 MCHC(g/L)= 100×HGB/HCT

 PCT(%)= PLT×MPV/10

 LYM% = 100 x AL /（AL+AM+AG）

 MID% = 100 x AM /（AL+AM+AG）

 GRAN% = 100 x AG/（AL+AM+AG）

 LYM# = LYM% x WBC/100

 MID# = MID% x WBC/100

 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.

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 Hardware

Chapter 2 HARDWARE
The instrument has the following hardware

CPU Board, CCU Board, cable adapter board, liquid path opt coupler adapter board, motor opt coupler adapter board, 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, COM interface, power supply interface, mouse/keyboard interface, display

screen TFT cable interface, peripheral display 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

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 Hardware

2.2 CCU BOARD

2.2.1 Function

The CCU board consists of six modules:

Digital Circuit Analog/Digital converted Analog Circuit

Drive Circuit Circuit

Power Circuit HGB Measurement Circuit

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2.2.2 Front Interface

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2.3 TFT Cable Converting Board

2.3.1 Function

The main function of MTB board is to contact every model with CCU board meanwhile can adjust sensitivity through

adjust the adjustable potentiometer on the MTB board.

2.3.2 Interface

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:

2.5 RECORDER BOARD

2.5.1 Function

The main functions of the recorder board are to

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 Hardware
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 2-6

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 Maintenance

Chapter 3 Tubing system

3.1 Tubing drawing

Chart 3-1
 Hardware

Tubing list

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3.2 STRUCTURE OF TUBING SYSTEM

3.2.1 Liquid path structure

Chart 3-2
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3.2.2 Tubing Sensor Unit

The instrument includes four tubing sensor: diluents 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 diluents” 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.

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Chapter 4 SYSTEM STRUCTURE

4.1 DISASSEMBLE/REPLACE PARTS AND COMPONENTS

4.1.1 Disassemble/Replace the Sample mechanism

Block

slider

Chart 4-1

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.

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 Hardware

4.1.2 Disassemble/Replace the Diluents Machine

Chart 4-2

4.1.3 Disassemble/Replace the Vacuum Block

Chart 4-3

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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.

Chart 4-4

4.1.5 Disassemble/Replace the Piston Block

Chart 4-5
It is necessary to replace the seal washer of the piston block periodically. The replacing cycle is one year.

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4.1.6 Disassemble/Replace Sample Cup

Chart 4-6

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Chart 4-7

Chapter 5 ADJUSTMENT
This part introduces how to adjust the gain of the machine

5.1 GENERAL
5.1.1 While user replace the counting chamber, it needs a gain adjustment as well.
WBC chamber: WBC gain, HGB gain.
RBC chamber: RBC, PLT gain.
5.1.2 Replace the aperture ruby
WBC ruby: WBC gain.
RBC ruby: RBC/PLT gain.
5.1.3 Replace CCU board
Need to adjust the gain of the WBC, RBC/PLT, HGB.

5.2 ADJUST PROGRAM

6 5.2.1 Adjust calibration parameter.
7 In main operation window, access with mouse: “Function---Calibration---Auto”. Adjust the calibration factors to

100%.

8 In main operation window, access with mouse:“Function---Service---Detect---Input 6666”, enter the factory mode.

9 In main operation window, access with mouse:“Function---Calibration---Manual” Calibration”. Adjust the

calibration factors to 100%.

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 Hardware
10 Use the calibration of Prokan 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.

11 In main operation window of the instrument, access with mouse: “Function---Service---Detect---Input 6100, click

“HGB Blank/T” key to adjust the voltage as 4.3±0.1V.

11.1 CCU Board Layout

Please refer to page 19 for detail.

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 Prokan.

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 doesn’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 the neutral detergent can be used .

Caution:

Avoid wiping the inner of the instrument.

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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 the appointed specification fuse can be used .

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 setting 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
When the instrument is shutdown, it will run daily shutdown auto cleaning procedure. 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 concentrated cleaner and strong cleaner.
b) In the main operation window, select “Function/Service/Maintenance/Enhance Cleaning” in the menu.
c) Turn off the power supply.
d) Wipe the appearance of instrument as section 9.1.1.

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

37
 Hardware

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 Prokan. Please contact the customer
service department of Prokan before yearly maintenance.

6.6 THE MAINTENANCE BEFORE TRANSPORT OR LONG TIME NO USE

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, choose “Function/Service/Maintenance” in the menu, select “Parking” button.
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, cleaner 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.

38
 Hardware

Chapter 7 TROUBLESHOOTING

7.1 Troubleshooting as below flow

Make sure the

ambient
Start instruments,
temperature Start up abnormal
observation equipment
humidity
self-test is normal, all Maintenance
atmospheric NG
moving parts is running
pressure are in Moving parts run
smoothly, and liquid road
line with our abnormal
system without leakage and N
other abnormalities, G
apparatus with alarm or not Liquid road
Make sure if the
system leakage
reagent is enough,
original reagent OK
and not expired

Blank data does not

Blank Test
meet the technical
Observe the test
Make sure the requirements
data and data gaps
voltage is correct NG Maintenance
is in compliance
to our instrument
with technical The amount of data
requirements or does not meet the
not technical requirement
--- High
Make sure the OK
reagent is
connected correct
Sample test
and reliable NG
The test result is Sample tests do
steady or not (CV not meet Maintenance
value is accord with technical
Make sure if any technical requirements
part is connected requirement
correctly and
reliable. OK

END

Chart 7-1

39
 Hardware

7.2 CHECKING ITEMS BEFORE MAINTENANCE

Items required for checking before maintenance:

Ambient Temperature: 15～35℃

Temperature of the reagent: 15～30℃

Humidity: ≤70%

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’t 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

Parameter Background Range Unit

WBC ≤0.2×109/L 109/L

RBC ≤0.02×1012/L 1012/L

HGB ≤1g/L g/L

40
 Hardware
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 pre-diluted mode, the sample needle aspirates some non-contaminated diluents from the

sample cup for background count. The diluents pick-up method as follows(Analyzing the sample in

pre-diluted mode, it is also necessary to dilute sample with the diluents which is prior picked-up in this

method):

In main operation area, select “Mode---Pre-diluted” to set the sample mode as pre-diluted mode.

In main operation area, Place a clean empty sample cup or tube under the sample needle, select “Diluents”.dispense the

diluents into the sample cup. Click the “Diluents” key once, the diluents is dispensed into the sample cup or tube once (The

quantity can be used for background count in the second pre-diluted mode).

Press “Exit” button to return to the main operation area.

Affected Factors of Background:

1、 The reagent is dirty.

2、 The sample cup 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

41
 Hardware

Chapter 8 Appendix 1: Label mark

No. Stick place Label name note
Sample structure monitor in the
1 Motor A MA
kickstand place
Sample structure monitor in
2 Motor B MB
horizontal axis fixed plate
3 Motor C MC Dilution monitor

4 Motor D MD Vacuum decelerating monitor

Sample structure switch in the
5 Opt coupler A OSA
kickstand place
Sample structure switch in
6 Opt coupler B OSB
horizontal axis fixed plate
7 Opt coupler C OSC Dilution switch

8 Opt coupler D OSD Vacuum decelerating switch

9 Dilute sensor DLS

10 Lyse sensor LYS

11 Cleaner sensor CLS

Waste liquid
12 WST
sensor
13 switch STA

14 MTB board MTB

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

42
 Appendix 2 Debug record form

Chapter 9 Appendix 2 Debug record form

Name: Host debugging techniques No: F-6105-30-02127 Edition：
Serial No. of product： Temperature： Humidity：
Item Requirement Result Note
According to the requirement of standard  OK
appearance
products  Not ok.
Refer to PE-6005 the requirement of “host  OK
fitting
production requirement”  Not ok.
Display Should display full screen and every label  OK
screen should clear and no color cast  Not ok.
Check the connection between jack and
Mouse  OK
mouse is connected well and can work in good
interface  Not ok.
way.
Check the connection between jack and
Keyboard  OK
keyboard is connected well and can work in good
interface  Not ok.
way.
Indicator It will light when standby and shine when  OK
light suck sample.  Not ok.
Reagent  OK
With words and sound alarm
alarm  Not ok.
Backboard With right direction and without notice  OK
fan cacophony  Not ok.
Date and  OK
Local date and time
time  Not ok.
With correct place and there is sound when  OK
valve
connected with electricity.  Not ok.
Data  OK
It will display “ok” when we check it.
circuit  Not ok.
HGB
Adjust to 4.31V V
black voltage
Burning Sample cup have sound of “Chichi”. The  OK
function indicator light will be on.  Not ok.
Motor and Smooth operation, no abnormal sound,
 OK
associated non-blocking phenomenon
 Not ok.
moving parts And the status of the test results should be "OK"
Sampling
needle tip
position Adjust the position with the sampling needle  OK
perpendicular position tool  Not ok.
to the direction
of origin
Negative
79.2±1 KPa
pressure of
 Hardware
vacuum
chamber
Vacuum
chamber leak ≤0.2 KPa /2Min
rate
5.0V
5.00±0.5V
voltage test
Reagent Temperature of thermometer should be ±5℃
temperature test the same as temperature inside of sample cup
Hole The 5 times average W.H.V.S value of bank
voltage test
reference value The 5 times average R.H.V.S value of bank
set up test
WBC voltage range 9 ～
19 V
Press T1
RBC voltage range 11～
Hole 23V
voltage test WBC voltage range less
than 3V
Press T2
RBC voltage range less
than 3V
Draining
the amount of
8.0±0.4ml
pre-diluted
mode
Test the voltage of liquid sensor is 3.0V ～
Test the
5.0V with reagent
voltage of
Test the voltage of liquid sensor is ≤1.5V
liquid sensor
without reagent
There is air bubble come out from bottom of  OK
Air Mixer
cup.  Not ok.
The ability
of sample cup
shield (cover)  OK
Resistance should be more than 20MΩ
and the  Not ok.
substrate
insulation
Channel Lymphocyte peak fL
gain RBC peak fL
WBC ≤0.2×109/L 0×109/L The
RBC ≤0.02×1012/L 0×1012/L  OK average
Take count
HGB ≤1g/L 0g/L  Not ok of blank
in blank
HCT ≤0.5％ 0％ test
PLT ≤10×10 /L9
0×109/L result
Oversee 12S+1S □ OK The
44
 Appendix 2 Debug record form
the time of □ Not ok average
blank counting value of 5
times
counting
time
WBC V Every
Set the
time of
Reference
blank
voltage value of RBC V
test is
pinhole
ok.

The liquid should flow cling to the needle

Add liquid □ OK
uniformly and there is no departure of needle and
cleaning kits □ Not ok.
no share phenomenon

WBC ≤200KB Any

RBC ≤100KB one
Channel  OK
blank
data volume  Not ok.
PLT ≤300KB test
result
WBC ≤0.5％
Carrying
RBC ≤0.5%  OK
contamination
HGB ≤0.5%  Not ok.
test
PLT ≤1.0%
Venous WBC
and RBC
Peripheral HGB  OK
blood MCV  Not ok.
calibration
Instrument parameter PLT
calibration
WBC
Pre
RBC
dilute  OK
HGB
calibration  Not ok.
MCV
parameter
PLT
WBC accuracy test ≤3.0%
RBC accuracy test ≤3.0%  OK
Accuracy
HGB accuracy test ≤3.0%  Not
test（CV）
MCV accuracy test ≤1.0% ok.
PLT accuracy test ≤7.0%
Venous Pre-dilution
blood model model
WBC accuracy
±6%
Test error range
 OK
accuracy RBC accuracy
±5%  Not
error range
ok.
HGB accuracy
±4%
error range

45
 Hardware
MCV accuracy
±5%
error range
PLT accuracy error
±14%
range
Printing characters, graphics should be correct, clear. The
Record functioning of institutions should be smooth. There is no abnormal □ OK
and alarm sound, no paper block but with alarm function phenomenon, there □ Not ok.
are alarm.
Pinter and Printing characters, graphics should be correct, clear. Meanwhile □OK
net function the PC can accept complete and correct data and graphic. □Not ok.

Whole
□OK □ Not ok.
estimation.

46
 chapter 10. appendix 3 troubleshooting

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 sample cup Exclude the bubbles

The reagent is inadequate Re-prime the reagent

Bubbles 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 sample cup Replace the back cover of sample cover

lacks

The reagent is contaminated Renew the reagent

Abnormal Electronic interference Connect the ground wire

background test Tubing contamination Clean the tubing

There are large-cells or debris in the Remove the debris from the sample

sample

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

Aperture clogs Clean the aperture

Inadequate diluents Check for diluents and piston block

MTB is broken Replace MTB board

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

Liquid crystal display screen is aging Replace the display screen

Abnormal HGB The WBC sample cup is dirty , Dip in the sample cup ,or adjust the gain

background voltage 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

47
 Maintenance
Some keys of the The CPU board or the keyboard is broken Replace the CPU board or the keyboard

keyboard is irresponsive

Liquid leaks Abnormal vacuum chamber pressure Replace vacuum chamber

The waste tubing is obstructed Dredge the waste tubing

Abnormal mid-sized The sample is placed a too long time Measure the sample within 30 minutes

cell percentage The anticoagulant is superfluous Reduce the quantity of anticoagulant.

Reagent is used up Renew the diluents

No reagent, Fluid hose seal in bad way Check the connection and get rid of liquid

Rinse(diluents/lyse) lack

empty alarm The piston block leaks Replace the piston block or seal ring

The rinse(diluents/lyse) sensor is Replace the rinse(diluents/lyse) sensor

broken ,or the connector is broken off

WBC/ RBC clogs The sample cup is dirty Clean the sample cup

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 hole is much Reset the reference voltage of hole

lower than the actual test values

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

RBC, WBC measurement The electrode cable is broken Replace or repair probe components

The result of RBC, The instrument is effected by high Get rid of the electromagnetic

WBC is high electromagnetic machine. Such as the machine.

instrument is not connected well with

ground

The liquid road is dirty Clean the liquid road and operate

maintenance program.

The sample is stared too long time Get new samples.

48