TEK-IIMini HEMATOLOGYANALYZER USER MANUAL PDF

 

 

TEK-IIMini HEMATOLOGY ANALYZER

USER’S MANUAL

Tecom Science Corporation

 

  TEK-II MINI Automatic 3-diff Hematology Analyzer User’s manual

Tecom Science Corporation

 

  Catalogue ●

  Foreword

●

  Copyright and declaration

●

  Product guarantee

●

  Instrument using environment

●

  Direction for safe use

●

  Chapter One

Installation

●

  Chapter Two

Introduction Introduc tion

●

  Chapter Chapter Three Three

Inspe Inspectio ction n Principle Principle

●

  Chapter Four

Operating Program

●

  Chapter Five

Inquiry Review

●

  Chapter Six

Quality Control of Instrument

●

  Chapter Seven

Instrument Maintenance

●

  Chapter Eight

Analysis and Elimination of Troubl Troubles es

●

  Reference I

Instruction of Online Application Software

●

  Reference II

Communication Protocol

●

  Index

 

Foreword At first, we really appreciate your purchase of TEK-II MINI 3-diff hematology analyzer. Please read this user’s user ’s manual carefully before using, and conduct the operation correctly. correctly. Please keep it properly after reading for future scan. In order to ensure the safe operation of instruments, please abide by the following notices. ● 

This illumination content include include all special fittings setting (sell separately).If you have not  purchased this kind of special special fittings setting, please jump jump over this contents when reading this operation manual. operation 

● 

This instrument is only used used for whole whole blood cell inspection analyzing, it it may not work normally except for this purpose.

● 

Please read read illumination before using this instrument, and use it under knowing well this illumination situation.

● 

Please operate operate this instrument instrument under the management management of engineers engineers who have well well trained by training company pointed by Tecom. Tecom.

● 

Please check check whether whether this instrument can can work normally by testing QC material material when using this instrument, incorrect testing result may cause wrong diagnosis.

● 

Do not disassemble disassemble or reassemble the unit of of instrument without the permission of our company because it is possible to cause the danger and the damage of instrument.

● 

Don’t apply the method not not indicated in user’s m manual anual because it is possible to cause the damage to instrument.

● 

Exporting the test result is recommended. That is for for prevent the storage history data lost  because of the instrument instrument failure.

● 

The approved technicians technicians by Tecom Tecom conduct assembling, assembling, augmenting, reassembling, reassembling, improving and repairing the equipments. Otherwise, Tecom Tecom will not responsible for it.

I. 

I

 

Copyright and declaration Te Tecom com Science Corporation has the copyright of this unpublicized manual and has tthe he right to treat it as conventional data. This manual is only used as operate and maintain TECOM products for your reference. Others have no right to make it public. This manual contains some proper data protected by the copyright law. It can not be duplicated, or translated to other languages without written consent from Tecom Tecom Science Corporation. TECOM does not make any guarantee to this material, including guarantee responsibility of implied merchantability proposed to it for some specific purpose. Tecom is not responsible for the mistakes in the material and the accidental of indirect loss caused by the actual use of this manual. The display figure in this book may be a little difference with the actual display figure. Due to the renewal of products, sometimes there would be some situations which disagree with the content of this manual, please pardon us for not giving notice separately. separately.

I. 

II

 

Product Guarantee

Guarantee period: One year after the installation date. Guarantee content:

Tecom will supply free amendment to customers due to the trouble caused by fault of our design, manufacturing during the guarantee period, but Tecom will take relative action as amend method according to the trouble content.  Non-guarantee Items Items (Non responsibility Items): If the following situation occurs, it is not include in the guarantee rang even within guarantee  period: 1. 

The trouble caused by used instrument out of using environment mentioned in this Illumination.

2. 

The trouble caused by wild operation, using by mistake, operation by mistake.

3. 

The trouble caused by removing, transporting, installation procedure and means which not  permitted by our company. company.

4. 

The trouble caused by self disassembly or reassembly instrument.

5. 

The trouble caused by fire, earthquake, wind harm, flood, lighting strike, crime, terrorism, war and other irresistible natural disasters.

6. 

The trouble caused by improper maintenance or maintaining companies which are not pointed  by Tecom. Tecom.

7. 

The trouble caused by not placing the consumables or spare parts that have life period in time.

8. 

The trouble caused by using hardware, software or assistant products not supplied by Tecom.

9. 

Circuit corrosion, optics component aging in evidence by strong corrosive gas in the air.

10.  The trouble caused by using condemned instrument or buy secondhand instrument without connecting with Tecom.

I. 

III

 

Using environment for instrument:

The relative service department of our company carries on the installation when purchase. Instrument should meet the following conditions and be used under the corresponding environment. 1. 

Less dust, good ventilation.

2. 

Avoid direct sunlight.

3. 

It is at least 20 cm far from the wall behind the instrument so as to radiate and connect  pipelines easily. easily.

4. 

There must be a power supply or socket within 1.5 meters away from the machine.

5. 

Good horizontal level, the intensity and areas are enough for enduring and placing 4 sets instrument (about 50Kg).All the reagent should be placed on the same horizontal level as the instrument, shall not be higher or lower than the instrument, the waste barrel shall be placed on the ground.

6. 

The room temperature should kept between 10   ~35  ,and the change of room temperature shall sha ll within within ±2

during during testi testing ng pro proces cess. s.

7. 

The room moisture shall not higher than 90%, no dew.

8. 

It is prohibited to use the instrument in the environment where the moisture is above 90%.If the instrument is used in the environment where the temperature is below 10   or above 30  , it is necessary to install an air conditioner.

9.   No appreciable shake. shake. 10.   No acute change change for power supply. supply. (within  AC220V±10%) 11.   No near strong electro-magnetic electro-magnetic disturbance disturbance (centrifuge, discharge discharge device etc.) 12.  There is sole grounding extremity.(the extremity.(the grounding resistance shall below 10Ω) 13.  This instrument is affected by electromagnetic wave, and may affect the data, cause the mistaking operation. 14.  The The ins instr trum umen entt sho shoul uld d sto store red d w wit ithi hin n --10 10

55  , the relative humidity shall not higher than

95%, atmospheric pressure between 500hpa to 1060hpa, no corrosive gas, shall place it in good ventilation and clean room.

I. 

IV

 

Directions for safe use

Before using, please read “Directions for safe Use” and using illumination carefully and conduct the operation correctly. For the sake of using instrument safely and correctly, and keep you and others or the possession far away from the damage, we use various symbols and signs. The meanings of symbols and signs are as follows: Please understand its meanings fully, then read the body of this book.

I. 

V

 

  Signs and meanings 

sign

О 

meaning

measure

Alternating current shut down(electrical down(electrical source cut) Alternating current turn on(electrical source turn on) Alternating current source

grounding Attention

To explain the important information in the operating process and some special operating skills. If not comply with the illumination, ill umination, maybe affect the output result or damage the products. Warning 

In the lab, when contacting with any

Admonish users pay attention to the potential

 possible biohazardous materials, materials,

dangers. There would do harm to human beings

You

or damage the products if not complying with

 protective clothes and gloves and

them.

comply with the prescriptions of

Warning 

safe operation or deal with them

Waste liquid have potential bio-infective hazard.

according to the demand of local

should

wear

the

standard

government.

 

Warning Some substances (samples, substance of quality

control, standard substance, waste liquor)have  potential bio-infective hazard. hazard. Warning 

Contact the manufactory to recycle

Admonish users pay attention to the potential

or deal with them according to the

dangers, electronic rubbish, easy to pollute

demand of local government.

environment. CE is the sign EU protect in accord, product should comply with the requirement of Directive 98/79/EC. Measurement sign

I. 

VI

 

 

Danger of electric shock 

Remind the user to avoid getting electric shock.

Warning I. 

VII

 

  ● 

In case the unusual odor appears, smoking is sent our, please cut off the power supply at once, and pull out the plug from the outlet.

If continue to use it, there will be danger of fire accident, getting electric shock or getting hurt. Please contact us or our agent as soon as possible.  ● 

The operator shouldn’t touch the inner circuit of the instrument, especially when the hand is wet, which will result in the damage of instrument, or getting the electric shock.

● 

Use the appointed tools or parts and components. The use and shift substitute is very dangerous.

 

●

Do not spill blood or reagent in the instrument, and do not insert pin and other metal into the instrument.

Otherwise there will be dangerous of short circuit and electric shock. In case the unusual situation appears, Please cut off the power supply at once, and pull out the plug from the outlet. outl et. Please contact us or agent as soon as possible.

Warning

I. 

VIII

 

 

Direction for electric source wire, voltage, connection and grounding: ● 

It is absolutely necessary to insert the eelectric lectric source source plug into the appointed outlet. Otherwise will causes fire accident or getting electric shock.

● 

When installing installing the instrument, the the electric electric source source or case case must be grounded; otherwise it will result in the unstableness of the instrument performances and the possibility of getting an electric shock. Do not use coal-gas tube as grounding equipment.

● 

Don’t put the heavy thing on the electrical source wire or pull it tightly, otherwise it will damage the electrical source source wire so as as to cause short short circuit or will will break the wire so as to result in the danger of fire accident to getting electrical shock.

● 

Before opening the instrument to maintain its inner parts the electrical source must firstly be cut off to prevent from getting the electrical shock or causing troubles.

● 

When connecting connecting the peripheral peripheral fixings(such as printer or barcode barcode scanner),it scanner),it is necessary necessary to cut off electrical source firstly, otherwise, there will be the danger of electrical shock or cause troubles. And before connecting it is necessary to be confirmed by our company so as to avoid causing troubles or damaging device.

● 

When replacing replacing a fuse, fuse, you should replace the fuse with the same specifications after after cutting off electrical source so as to avoid getting electrical shock, causing troubles. 

Warning

I. 

IX

 

 

Biohazardous Material:  ● 

Protective robber gloves are strongly recommended recommended when operating, maintaining, or servicing TEK-II MINI. Obey the lab safety operate regulation.

● 

Do not touch touch these materials (samples, substance of quality control, standard substance, waste liquor) when operating, disassembling, assembling relative components or disposing waste liquor without careful, firstly wash by the disinfect liquor, then wash evenly by soap.

● 

If contaminated contaminated by the blood or waste liquor, immediately wash with with sterilized sterilized liquor and then rinse with clean water, and follow the doctor’s instructions.

● 

Take more more care when dealing dealing with samples, must put on rubber glove, glove, having the  possibility infected by viruses. In case touch the eyes or wound, firstly flush with plenty of water, then follow the doctor’s instructions.

Warning 

Biohazardous Material:  ● 

When disposing disposing with the waste waste liquor, liquor, do not touch waste liquor directly, directly, must put on rubber glove, because there have the danger of potential biology epidemic. If touched by waste liquor, flush with disinfect liquid firstly, and then wash with soap fully.

● 

Customers have the o obligation bligation to fo follow llow all the related regulations regarding the release of waste liquid in the local l ocal district or country.

Warning

I. 

X

 

  Reagent using notice: ● 

If touched touched by eyes, m must ust flush with plenty plenty of water immediately, immediately, and follow the the doctor’s doctor’s

Instructions. ●

 

If take by accident, accident, call call the doctor immediately immediately and and at the same same time drink plenty plenty of water and sick.

● 

If the skin or hands are are contacted contacted with with the reagent, please flush it with plenty of clean clean water immediately.

Attention 

I. 

XI

 

Direction for matched reagent: ● 

After sealing off, care that the dust, dirt or microbe microbe and and shouldn’t shouldn’t m mix ix with in reagent. reagent.

● 

Do not use overdue reagents.

● 

In the process of replacing replacing and applying re reagent, agent, care care that that the bubble should not be  produced in it.

● 

Use the reagent according to the notices on the label or reagent.

● 

Do not take it by mistake.

Directions for using equipments: ● 

When maintaining and repairing instruments, use appointed tools or the parts parts and components with original package.

● 

Do not let anyone who doesn’t understand the instrum instrument ent or hasn’t been trained specially use the instrument at will. Anyone who uses the instrument must be trained specially, or the accuracy of result can’t be ensured.

● 

Do not let your cloth or body close to the operating instrument.

● 

If there there is trouble with the instrument, please contact our company company or our distributors. O Our ur company is responsible for repairing it. The guarantee period is shown in the contract.

● 

In case there is other problem problem with the instrument, instrument, please read the Chapter Eight Eight of this Operation Instruction Manual carefully. The person in charge of the instrument should deal with the problem. If necessary, necessary, please contact our company or our distributors.

● 

Forbid used at home.

Direction for the environment where the instrument is used: I. 

● 

The instrument must be fitted in the place where

XII

 

water, moisture, dust, high-temperature, directly rays of sun vibration and corrosion should  be prevented and which which is far from the strong electro-magnetic disturbance. disturbance.

I. 

● 

Do not not be installed where chemical medicines are stored or gas could could be produced.

● 

Do not suffer strong shock or strike.

XIII

 

Chapter One Installation

Chapter One

Installation

Before using, please refer to the statutes of using environment to confirm if it is suitable to the statutes of using environment. 1. 

The installation of hematology analyzer is Installed by our company or our agency agency.. Take apart the package carefully, examine the appearance. Please declare promptly if there is damage by transit. Check the equipment and packing list to insure that collocation is complete. If collocation is not complete, please inform Tecom or the local agency. If the fault is caused by users moving the equipment proper motion, it is not included in the guarantee object even in the guarantee period, please note that.

2. 

Grounding The power supply should adopt three-pin plug, If there is grounding jack in the outlet, the plug may be inserted directly for using. If there is no grounding jack, the adapter must be used to ground the earth wire.

3. 

Stable voltage Power of 220V,50Hz is required, wave is required within ±10 . Special power supply should be used for equipment, and should be used under stable voltage, if it is conditional, high precision purified stable power supply should be equipment.

Warning

Direction for electric source wire, connection and grounding

 

●

It is absolutely necessary to insert the electric electric sourc sourcee plug into the appointed outlet. Otherwise it will cause the fire accident or get electric shock.

 

●

When installing the instrument, the electric electric source source or case must must be grounded; otherwise it will result in the unstableness of the instrument performances and the possibility of getting an electric shock. Do not use coal-gas tube as grounding equipment.

● 

Do not put the heavy thing on the electrical source wire or pull it tightly, otherwise it will Damage the electrical source wire so as to cause short circuit or will break the wise so as to result in the danger of fire accident or getting electrical shock..

1- 1 

 

Chapter One Installation

4. 

Connection of pipeline Take out the pipeline of diluent, lyse, detergent and waste liquor. and connect it according to the sign behind the equipment on one end, then connect the other end with the reagent (waste liquor)barrel. Please pay attention to each sign of pipeline. Do not mix it and protect pipelines. Do not fold it.

5. 

Installation of printing paper. Printer explaining figure

Paper outlet

Pd

Paperboard key Printing Head

Boss SEL Key

Front Plate Transparent

Indicator

Window

Light

LF Key

Paper outlet 

Papering Axe 

Clip trough

Get the front plate down from the printer by moving the front plate forth with finger, finger, please refer to Fig.1

Fig.1 Get the bosses at two sides of the printing head with fingers and move them out, please refer to Fig.2 and Fig.3

1- 2 

 

Chapter One Installation

Fig 2 

Fig 3

Draw the printing head of papering place with hands, please refer to Fig.4.

Fig 4 

Fig 5

Please make the paperboard key forth at the left side of printing head, please refer to Fig.5 The thermal paper has two sides, only the smooth side can be printed and the side must be adown; Press the LF Key and the paper will put in the paper inlet slowly and please press the LF Key again for stopping while the paper out of the outlet. Press the paperboard key down, please refer to Fig 6;Press the printing head into printer with hand. Refer to Fig.7.Put the papering axe into the paper hole. use thumb and forefinger to clamp both side of the papering axe.

Fig 6 

Fig 7

1- 3 

 

Chapter One Installation

Fig 8 

Fig 9

Fit the papering axe into the clip trough of the printer, please refer to Fig.8;push “SEL” Key and the indicator light is on, make the paper out from the outlet with the front plate and cover the front plate and then the printer keep in waiting condition, please refer to Fig.9  Note  Thermal printer only uses special thermal paper and need not change the ribbon. 6. 

Connection of barcode scanner (expand choose the fittings) Make sure the instrument is under the power off condition, it is better to pull out the power line from the connection board, then connect the interface of code scanner with the interface of scanner behind.

7. 

Connection outside printer (expand choose the fittings) Make sure the instrument and printer are in the power off condition, it is better to pull out the  power line from the connection board, then connect the interface of printer to the USB interface or PRINTER interface of the instrument behind.

8. 

Connection of computer (choose the fittings) Make sure the instrument and computer are in the power off condition, it is better to pull out the power line from the connection board, then connects the RS-232 interface of computer mainboard with RS-232 interface of the equipment back through serial port wire. Please see the Installation of online application software in reference part I.

Warning

Direction for electric source wire, connection and grounding ● 

When connecting the peripheral fixings (printer and barcode scanner),it is necessary to cut off   electrical source firstly, firstly, otherwise, there will be the danger of electrical shock or cause troubles. And before connecting it is necessary to be confirmed by our company so as to avoid causing troubles or damaging device.

1- 4 

 

Chapter Two Introduction

Chapterr Two Chapte Article One

Introduction Introducti on

General Outline of Instrument

I. 

Instrument Appearance:

II. 

Fittings and consumables:

Reagent:

Diluent . Lyse

Detergent.

Reagent of maintain:

Concentrate Cleaner Reagent of QC substance:

QC substance. Other consumables:

Printing paper

2- 1 

 

Chapter Two Introduction III.

Testing Items

Instrument name: TEK-II MINI Automatic 3-diff Hematology Analyzer (Hematology Analyze Analyzerr for short) (Different type’s menu and function are a bit of unlikeness).It can determine the following items in blood: Testing Items

Indication

Meanings

Unit

Quantity of white blood cells in each litre of

9

Quantity of white blood cells

WBC

Value of lymphocyte lymphocy te group

LY#

Absolute Absolu te value of lymphocy lymphocyte te group

10 /L

MID#

Absolute value of intermediate cell group

10 /L

GR#

Absolute value of granulocyte group

10 /L

Value

of

intermediate

cell

group Value of granulocyte group The percentage of lymphocyte group The percentage of intermediate cell group The percentage of granulocyte group

LY% MID% GR%

 blood

10 /L 9

9

9

The ratio of lymphocyte group relative to white  blood cell quantity The ratio of intermediate cell group relative to white cell quantity The ratio of granulocyte group relative to white  blood cell quantity

% % % 12

Quantity of red blood cell

RBC

Quantity of red blood cell in each litre of blood

10 /L

Specific volume of red blood cell

HCT

Specific value of the volume occupied by red  blood cell in each litre of blood

L/L

MCV

Average volume of red blood cell in blood

fL

Average volume of red blood cell Average hemoglobin value of red blood cell Average

concentration

of

hemoglobin of red blood cell Coefficient

variation

MCH MCHC

RDW-CV

cell volume Standard

each red blood cell Average concentration of hemoglobin of red  blood cell

 pg g/L

When the peak value of distribution curve of red

of

distribution width of red blood

Average quantity of hemoglobin contained in

 blood cell grain size is 100%, the HGB distribution width of red blood cell is calculated

%

from 68.26% points of whole area Difference

of

distribution width of red blood

RDW-SD

cell volume

When the peak value of distribution curve of red  blood cell grain size is 100%,the HGB distribution width of red blood cell is 20% points

fL

from below

Content of hemoglobin

HGB

The quantity of hemoglobin in each litre of blood

g/L

Quantity of thrombocyte

PLT PLT

Quantity of thrombocyte in each litre of blood

10 /L

Specific

volume

of

thrombocyte Average thrombocyte

volume

of

PCT MPV

The specific value of volume occupied by thrombocyte in each litre of blood The average volume of thrombocyte in blood

2- 2 

9

L/L fL

 

Chapter Two Introduction

When the peak value of distribution curve of Distribution

width

of

thrombocyte volume

thrombocyte grain size is 100%,the distribution

PDW

width of thrombocyte is calculated from 68.26%  points of whole area.

● 

White Blood Cell Histogram

Afterr adding the hemoly Afte hemolytic tic reagent, reagent, the range range of the white blood blood cell volume volume is 35—400fl 35—400fl

100

200

300

400

fl

●  Red Blood Cell Histogram The range range of of the the red red blood cell is

25—25 25—250 0 fl

100

200 250

fl

20

30 f l

●  Platelet Histogram The range of the thrombocyte is: 2—20fl

 

10

2- 3 

 

Chapter Two Introduction

IV

  Basic Parameters Parameters of Instrument Instrument 

Dimensions of aperture

WBC  80μm diameter RBC  80μm diameter

Dilution Dilutio n proportion proportion

whole blood: blood: WBC/H WBC/HGB GB 1 251 RBC/PLT

1 50000

Sample Sam ple quanti quantity ty

Wh Whole ole blood blood 20μl

Category of sample

EDTA EDTA sylvite anti-freezing venous blood or ti p blood

 

Eliminate block mode

Have perfect eliminate block program(include high voltage burning. positive rinse. reverse rinse)

Power supply

 AC 220V±10% 50Hz±1Hz

Consumption power

≤80VA

Standing working time

24 hours

Interface

RS232

Expand interface

USB. LPT port. Keyboard/Scanner Keyboard/Scanner interface

Display Dimensions Data input

320×240 LCD Englis English h Version

Working orking tem temper peratu ature re

15 -30 

Φ5×20(mm) T1A 250V 

Fuse Air pressure range

70 70.0 .0kp kpa a 10 106. 6.0k 0kpa pa

Storage temperature 

-10

Working relative humidity 

≤90

Storage relative humidity 

≤95

Volume

  55

370mm×275mm×400mm

Net Weight

about 12.5Kg 

V. Performances of Ins Instrument trument IPLT tem 

0.99Coefficient r Linearity Rel≥ative

WBC 

≥0.99

RBC

≥0.99

HGB 

≥0.99 2- 4 

 

Chapter Two Introduction

VI 

Menu of Tree Structure Record review Soak and Rinse

Testing Aperture

Maintenance

System diagnosis Prime Det

Prime Dil Prime reagent

Menu

Prime Lyse

Prime All

Calibration Range Setup Preference Time Setup Target QC

QC

Float QC

Shut down

2- 5 

 

Chapter Two Introduction

VII Explanation of Operation Interface  1. Main Interface

Menu

Record

Thank you for use T E K -II Mini Analy Analyzer zer  Automatic 3-diff Hematology Analyzer

F1

7

8

9

ESC

F2

4

5

6

P U

F3

1

2

3

P D

F4

0

PRI

YES

Testing Maintenan QC Shut

xxxx-xx-xx

F5

xx-xx-xx

NO

2.Key Explanation  

 Name

Function

F1~F5

For the selection of function menu of each interface

0~9

For the input of sample number, number, data of setting value, etc. For the selection of menu, the cursor will be up, down, left and right while press the keys

Print

For the print of the testing result

PgUp, PgDn

For the change and read if there are several pages

Determination/Confirm Cancel/Delete

For the determination of setted data, function keys, etc. For deletion of setting data

Exit

For the exit of the interface and back to the above interface

3. Explanation  

Record review Press F1  Testing  Press F2 

to enter the testing program.

Maintenance Press F3  QC  Press F4 

 

to enter the program to inquire record.

to enter the maintenance program.

to enter the quality control program.

 

 

Shut down Press F5

to enter the shut down program.

2- 6 

 

Chapter Two Introduction

4. Testing Interface

Result ID 001 Item Item WBC

Result sult 0.0

Unit

RBC HGB HCT MCV MCH MCHC PLT

0.00 0 0.000 0.00 0.00 0 0

10^12/L 

10^9/L 

g/L L/L fL pg g/L

10^9/L 

Item tem LY%

Resul sult 0.0

Unit %

MID% GR% LY# MID# GR# RDW-CV RDW-SD PDW MPV PCT

0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.000

% %

Histogram

ID. Set

10^9/L  10^9/L  10^9/L 

% fL % fL L/L

F2 

Result  Testing value of sample parameter Press“ 

”  to enter histogram

ID. Set  Press F2  and the cursor will stay in the “ No:  No:”   inputting the new number number can replace the original one.

Test result res ult value  NO 001 Item Result WBC 0.0 RBC 0.00 HGB HCT MCV MCH MCHC PLT

0 0.000 0.0 0.0 0 0

WBC Unit 109/L 1012/L g/L L/L fL pg g/L 109/L

[fl]

0 50 100

300

400

RBC

[fl] 

0

50

100

200

PLT

[fl] 

02 5

10

20

30 

2- 7 

 

Chapter Two Introduction

Article Two

Reagent  

I.  Reagent, Quality Control Substance and Standard Substance Reagent, QC substance and standard substance make up of a system, should work as an entirety, reagent used in this instrument is open, but in order to ensure good result, please ensure that all the products were inspected by manufacturer. Propose do not use reagent or QC substance supplied by different suppliers, otherwise the instrument can not obtain its i ts performance target, The reagents have not been inspected may supply irresponsible data. The reagent mentioned in this text is refer to the special reagent used in TEK-II MINI automatic 3-diff hematology analyzer. Each type of reagent shall be examined before using, damage of container may affect the quality of reagent. If the package is damaged, please check if there is leakage or damped evidence. If this situation exit, then the reagent can not be used. It is necessary to know its notice items during using chemistry reagent.

1.  Reagent

The reagent matched to use in this instrument i nstrument are: diluent, lyse, detergent.

● 

Diluent Diluent will dilute the blood sample and at the same time it can supply with the similar

environment for blood plasma, to ensure the configuration of the blood cell within certain time, and provide a electric environment for the blood cell counting.

● 

Lyse Lyse can destroy red blood cell membrane quickly, and lessen the volume of cell

fragment to the volume that will be noninterference to the WBC counting, and meanwhile change the configuration of WBC, divide into three diff to classified. The destroyed RBC will release hemoglobin and reactive with lyse to come into being a special complex substance, determine concentration of hemoglobin by colorimetry.

● 

Detergent Detergent is used to clean the pipeline and counting pool, this detergent is a specific

reagent, does not destroy the liquor pathway of the instrument. 2- 8 

 

Chapter Two Introduction

● 

Concentrated detergent Concentrated detergent used to instrument maintenance.

Warning Direction for using reagent:

● 

In case of entering entering into eyes by mistake, shall rinse with volumes volumes of water promptly promptly and see doctor immediately. immediately.

● 

In case case of taking by mistake, shall call call for doctor immediately immediately and meanwhile meanwhile drink volumes of water and chunk up it.

● 

In case case of stain on on hands or skin, shall rinse rinse with with volumes of water water promptly promptly..

2.  Standard substance and QC substance

Standard substance and QC substance are used to calibrate and quality control for the instrument. Standard is a kind of whole blood product or latex atom for commercial producing, are used for calibrate for instrument and ensure the veracity of testing result. The instrument has been calibrated before leaving factory, but it may cause excursion during the process of transporting and operating, system deviation can be found through QC, and it needs to calibrate calibrate   for the instrument. QC substance can be commercial whole blood or fresh blood, is used for checkout whether the instrument test is normal. Generally, QC substances have three types of high, mid, low value. Running three types of QC substance can checkout the running state of instrument to ensure the veracity and reliability of the result.

2- 9 

 

Chapter Two Introduction

Warning

Hazardous and Biohazardous Material  ● 

Operator shall dress rubber rubber gloves when operating maintenance and inspection and abide the lab safety operation regulations.

● 

Do NOT touch the waste these materials(sample, materials(sample, reagent, QC substance, substance, standard standard substance, wasting liquor) when operating, assembling, disassembling associated parts or disposing of waste, because they contain potential bio-infectious danger. If accidental contact with waste, immediately rinse with disinfect liquor at first and then wash with soap completely.

● 

When polluted by blood, waste, please rinse with with disinfect disinfect liquor, liquor, then then flush with clean clean water,, and see doctor to deal with it. water

● 

Pay more attention attention to that you shall wear wear rubber rubber glove when deal deal with with sample. It has  possibility of infected by pathogen. In case of it enter eyes or wound, shall rinse with volumes water at first, then see doctor to deal with it immediately.

II. 

Reagent pack and deadline  Name

Packing Specification Specification

Diluent

20L/bucket

Lyse Detergent

Note:

1L/bottle

Dosage About550 samples/20L About950 samples/1L

5/L bucket or

About

1/L bottle

60-100mL/day

The consumption of reagent is related to the quantity of everyday samples, times of start

and shutdown and maintenance.

2- 10 

 

Chapter Two Introduction

III. 

 Notice for relative reagent:

1) The hemolytic reagent used for this instrument instrument does not contain cyanide . 2) Storage condition of reagent must must according to the eexplanations xplanations on its label. 3)  The re reage agent nt must must be used used in the the norma normall te tempe mperat rature ure from from 15 4) 

to 30 30 .

After unsealing the package of reagent, pay attention not to mixing dust, dirt, microbe etc. with the reagent, and not letting dust adhere to the suction tube of reagent which will contact the reagent.

5)  A prime of reagent must be carried out once to avoid producing bubble, only after confirming the blank value is qualified, you can start to test the sample after replacing the reagent. 6)  When replacing the reagent, be sure not to pour the residual reagent into the new reagent to avoid the pollution.

Attention

Direction for using reagent

● 

After sealing off, care that the dust, dirt or microbe microbe shouldn’t shouldn’t mix w with ith reagent. reagent.

● 

In the process of replacing replacing and applying re reagent, agent, care care that that the bubble should not be  produced in it.

● 

DO Not use the reagent exceed the deadline.

● 

Use the reagent according to tthe he notices recorded on the the label label or reagent. reagent.

● 

DO NOT take it by mistake.

IV. The permissive blank value of reagent 9

●  WBC

≤0.3×10 /L

●  RBC

≤0.02×10 /L

●  HGB

≤1g/L

●  PLT

≤10×10 /L

12

9

2- 11 

 

Chapter Three Principle

Chapter Three Article One 

I.

Principle

Counting Principle of Blood Cell

Principle of Electrical Impedance Method

The counting determination of white blood cell, red blood cell and platelet is carried out by the  principle of electrical impedance method on this instrument; The determination of hemoglobin is carried out by the principle of photoelectric colorimetric method; MCV and MPV are determined according to the magnitude of pulse; other undetermined parameters are known by program computation. As it is shown in figure that when the diluted blood cell suspended in the electrolytic solution flows through the aperture, because the positive and negative electrodes are placed in the electrolytic solution on the sides of aperture the electric resistance abides by Ohms Law: R=V/I=P (L/A).

Outer electrode

Inner electrode

Blood cell flowing through aperture Inner electrode 

Electrolytic solution

When the cell flows through the aperture rapidly, because the cell is not a good conductor, the increase of voltage R of aperture is equivalent to the decrease of sectional area A of aperture under the condition of a constant electric current, the instantaneous change of voltage appears and an electric pulse is produced, the quantity of electric pulse is equal to the quantity of cells flowing through the gem aperture. The magnitude of electric pulse is proportional to the magnitude of cells so as to count the quantity of cells and determine the magnitude of cells.

1.  3-1 

 

Chapter Three Principle

The testing of HGB 

II.

The TEK method for determining hemoglobin is an adaptation of no-cyanmethemoglobin method .The lyse in the WBC/HGB dilution creates reaction. A measurement of the concentration of the hemoglobin derivatives is made using the optical absorbance of 540nm ±2nm light. The hemoglobin measurement is compared to a reference measurement made prior to each test when WBC cuvette is filled with diluent. A function of the ratio of the two measurements determines the concentration of hemoglobin.

III.

Calculation Parameter 

1. The HCT is automatically calculated using the instrument’s RBC and MCV measurement data. The computation is performed using the following equation:

HCT 

2.

MCV  fL ×RBC 1012/L ×10

1

The MCH is automatically calculated using the instrument’s RBC and HGB measurement data. The computations is performed using the follow equation: 12

HGB g/L ×10   MCH pg 

 ──────────────   ──────── ────── RBC 1012/L

3.

The MCHC is automatically automatically calcula calculated ted using the HGB

RBC and MCV. MCV. The computations

is performed using the follow equation 

HGB g/L

MCHC g/L    ─────────────  ×103   ───────────── ×10 12 RBC 10 /L  ×MCV  fl 

4. The distribution width of red blood cell: if the peak value of distribution curve of red blood cell’s granularity is 100  , the distribution width of red blood cell is counted from the points 1.  3-2 

 

Chapter Three Principle

accounting for 68.26 

of the total area: 

L2-L1 RDW-CV(%)

 ───── ×100% ×100% L2+L1

68.26% the total area of granularity

L1

5.

L2

The specific volume of platelet is evaluated by the following formula according to PLT and MPV 

PCT  

6.

9

MPV  fL ×PLT  10 /L ×10

1

The distribution width of platelet: if the peak value of distribution curve of platelet

granularity is 100  , the distribution width of red blood cell is counted from the points accounting for 68.26 

of total area: 

L2-L1 PDW-CV(%)   ─────×100% L2+L1

68.26% of the total area of granularity

L1

L2

Explanation of Parameter 1.  White Blood Cell (WBC)

White blood cell may be divided into three parts by mutual action of dilution and lyse lyse::  lymphocytes group; mainly lymphocyte; mid-size cell group; mainly monocytes cell, eosinophils,  basophils, Neutrophilic granulocyte granulocyte group: mainly neutral neutral granulocyte. The test of white blood cell may be interfered by abnormal specimen, such as: the coacervation of  platelet, nucleated red cell, condensed globulin, abnormal lymphocyte etc., all these will cause abnormal to the count of white blood cell and histogram. The drug having the cell’s toxicity and 1.  3-3 

 

Chapter Three Principle

immunity inhibition used for chemotherapy may change the action of hemolytic agent on white  blood cell to cause the count count of white blood cell decrease decrease obviously. obviously.

2. Red Blood Cell (RBC) The visible components of blood cell are contained in the dilution of red blood cell, including: red  blood cell, white blood cell and platelet. In the process of counting red blood cell the volume of  platelet is smaller than that of red blood cell, therefore the red blood cell may be divided from  platelet. The difference in normal proportion of white blood cell to red blood cell is very wide, so the influence of white blood cell on red blood cell may neglect. The test of red blood cell may be interfered by abnormal specimen, such as: cold agglutination syndrome, the noticeable increase of white blood cell count, a large quantity of huge platelet etc., all these can cause abnormal to the count of red blood cell and histogram. 3. Hemoglobin (HGB)

After lyse is added to the diluted blood, the red blood cell is dissolved to release hemoglobin, which is combined with the hemolytic agent to form the derivative of hemoglobin. The hemoglobin can be determined by colorimetry under 540nm. The test of hemoglobin can be interfered by the abnormal specimen such as hyperlipemia, high  bilirubinemia disease etc., all all these will cause abnormal abnormal to the test of hemoglobin. hemoglobin. 4. Platelet (PLT)

The test of platelet can be interfered by the abnormal specimen, such as small red blood cell, incomplete red blood cell, coacervation of platelet etc., all these can cause abnormal to the test of  platelet and histogram. histogram. 

1.  3-4 

 

Chapter Three Principle

Article Two

. 

Introduction of Fluid System 

The flow diagram of fluid system of whole blood mode  5mL

 

The The cou count ntin ing g p poo oo RBC

Diluent 

 

  3mL The counting WBC WB C 

pool

of

The count of RBC, PLT

25μL of

The count of WBC 3.015mL 1mL

utom utomat at c asp ra rate te 20ul

Lyse

The colorimetric determination of HGB

II. Introd Introduct uction ion of techno technologi logical cal pr proces ocesss 1. 20ul whole blood sucked with aspirator tip is added to the counting pool of WBC, into which about 3ml dilution is poured at the same time to dilute the whole blood the concentration of 1:251 2. Take 25 µl dilution of blood cell 1:251 to be poured into the counting pool of RBC, into which is added 5ml dilution to achieve the concentration of 1: 50,000. 3. Afterwards 210 µl dilution of blood cell of 1:50,000 passes the aperture and the count of red  blood cell and platelet is carried carried out according according to the principle of electrical electrical impedance. 4. After 1ml lyse is added into the counting pool of white blood cell (3.0ml), the dilution is added to be diluted to the concentration of 1:268. Then 210µl dilution of blood cell passes the aperture and the count of white blood cell is carried out according to the principle of electrical impedance, at the same time the photoelectric colorimetric determination of hemoglobin content is carried out for the derivative of hemoglobin without cyanogens. 

1.  3-5 

 

Chapter Three Principle

Article Three

Establishment of WBC Classification

. Establishment of the boundary mark of WBC diff D1

50

D2

100

200

300

400

fL

In order to diff WBC more accurately, the precise boundary mark is used for this instrument.

II. Calculation of WBC classification  1. The region of small-sized white blood cell group is from 35fl~Dl region. There are lymphocytes mainly in this region, the pulse number of white blood cells in this part is conversed into determined value of lymphoc lymphocytes ytes

LY#  .

2. D1-D2 region is the region of mid-size cell group. In this region there are mononuclear, eosinophils cells and basophils mainly, the pulse number of white blood cells in this part is conversed into the determined value of mid-size cell group (MID#). 3. D2-400 region is the region of large-sized white blood cell group. In this region there are neutral granulocytes mainly, the pulse number of white blood cells is conversed into the determined value of neutral granulocyte group (GR#). 4. The calculation formula of the proportion of lymphocyte group is as follows: LY# LY% =  ───────── ×100%  ──────────  ─ ×100%     LY# + MID# + GR#

2.

The calculation formula of the proportion of intermediate cell group is as follows:  

MID # MID% =  ───────── ×100%  ──────────  ─ ×100%     LY# + MID# + GR#  3.

The calculation formula of the proportion of granulocyte group is as follows  

GR# GR% =  ───────── ×100% ×100%  

LY# + MID# + GR# 1.  3-6 

 

Chapter Three Principle

Article Four  Collection and Measurement of Specimens  I. Collection of Specimens  1. Choice of anticoagulant: EDTA-K  EDTA-K 2 or EDTA-K 3. 2. Dosage of anticoagulant: 1.5~2.2mg/ml blood. 3. According to the dosage of anticoagulant take venous blood or capillary blood. 4. The tissue fluid may be easily mixed with the tip blood taken from earlobe or finger because of taking blood improperly to cause the blood to be solidified and the platelet to decrease, therefore, the blood should be mixed with anticoagulant as quickly as possible when it is taken. 5. The quantity of blood to be taken must be more than 50ul. 6. The blood should be determined after it is fully mixed. 7. It would best that the fresh blood should be determined within 15 minutes~4 hours after it is taken. 8. After being refrigerated the anticoagulant blood may cause the white blood cell’s classification to deviate and the histogram abnormal. After taking it out from refrigerator the blood will be tested after it is placed 30 minutes at the normal atmospheric temperature.

Warning   Hazardous and Biohazardous Material   

●

Operator shall dress rubber gloves when operating maintenance and inspection and abide the lab safety operation regulations.

 

●

Do NOT touch the waste these m materials aterials (sam (sample, ple, reagent, reagent, QC substance, standard substance, wasting liquor) when operating, assembling, disassembling associated parts or disposing of waste, because they ccontain ontain pote potential ntial bio-infectious bio-infectious danger danger..

If accidental accidental

contact with waste, immediately rinse with disinfect liquor at first and then wash with soap completely.  

●

When polluted by blood, waste, waste, please rinse with disinfect liquor, then flush flush with clean water, and see doctor to deal with it.

 

●

Pay more attention to that y you ou shall wear rubber glove glove w when hen deal deal with with sample. sample. It has

possibility of infected by  pathogen. In case of it enter eyes or wound, shall rinse with volumes water at first, then see doctor to deal with it immediately.

1.  3-7 

 

Chapter Three Principle

II. Testing Testing of Specimen 1. Turn the test tub (bullet head) upside down, mix the blood evenly (see Fig. 1). 2. Open the lid of test tube, pay attention to not scattering the blood (see Fig. 2). 3. Place the specimen under the aspirator tip, move the specimen until the aspirator tip enters the  blood, then press down the start start key (see Fig.2) 4. After the aspirator tip rises automatically, automatically, move the specimen away.

Fig.1

1.  3-8 

Fig. 2

Fig. 3

 

Chapter Three Principle

Article Five Structure and Function of External Parts of Instrument

I.

Frontal plane  

II 

Rear plane

1.  3-9 

 

Chapter Three Principle

Structuree of Extern Structur External al Part  LCD display: It indicates the working interface of instrument and the test result.  Keyboard: The input of letters, number and the operating control of instrument  Micro Printer: Print the result. Aspirator tip: The sample is sucked automatically Start key: Press down this key, the test circulation of system is started.  LCD Tuner: Tune the LCD brightness Interface Inter face USB(Expa USB(Expand) nd) Conne Connect ct equipments equipments like printer, printer, etc.. Scanner Interface(Expand):Connect Barcode Scanner. Scanner. Printer Interface(Expand): Connect printer. printer.

RS 232 Connect computer. Fuse Tube  Fuse Installation location. Power Switch: Power supply control of instrument  Power plug Connect alternating current.

Grounding Bolt  Connect the earth wire . Detergent interface: Connect the detergent.  Dilution Interface: Connect the dilution  Lyse Interface: Connect the Lyse.  Waste liquor interface: Connect the waste liquor.

1.  3-10 

 

Chapter Three Principle

III. Pipeline Diagram

1.  3-11 

 

Chapter Four Operation Program

Chapter Four Article One I. 

Operation Program

Daily Operation

Samples testing

1.  Check before befor e T Testing esting 1). Check whether the reagent pipeline of instrument and the connecting condition of electric source wire is normal or not. 2). Check whether the reagent is enough to test for a day or not, the mouth of sucking pipe of reagent is put under the liquid surface or not. 3). Check whether the printing paper is set up well or not. 4).Check the electric source firstly, then switch on the power of the machine.

2.  Starting the Machine 1). Switch on the power, The instrument screen displays:

4- 1 

 

Chapter Four Operation Program

2) Then instrument will self-check automatically and display:

Examining system 

Prompt Examining system, please wait · · ·

Fig. 4-1

3) The instrument will check the switches of the electromagnetic valves, motor and pump in the system automatically, and also use the diluent to wash the fluid pipeline and make local test automatically,, and report the automatically t he result.

Background test report

WBC

000.0

RBC

00.00

HGB

0000

PLT

0000

Enter

Fig. 4-2

4- 2 

 

Chapter Four Operation Program

 Note  Perm Permissive issive testing testing value value of backgroun background: d: 9

WBC≤0.3×10 /L

12

RBC≤0.02×10 /L 

9

HGB≤1g/L 

PLT PLT≤10×10 /L

4) Please press the “Enter” to enter main menu after background test and the screen s creen displays 

Main menu Review

Welcome to use Tecom Test

T E K -II MINI  Automatic 3-diff Hematology Analyzer

Maintenanc e

QC

Shut down xxxx xxxx-x -xxx-xx xx

xx xx  xx

3.  Test Press F2  test key in main menu and enter testing program, then test the daily samples.

Test result value  NO 001 Item re resu sult lt

Unit

It Item em

Res esu ult

Unit

9

WBC RBC HGB HCT MCV MCH MCHC PLT PL T

10 /L 1012/L g/L L/L fL pg g/L 109/L

Diagram

LY% MID% GR% LY# MID# GR# RDW-CV RDW-SD PDW MPV PCT No. set  

% % % 109/L 109/L 109/L % fL % fL L/L F2

4- 3 

 

Chapter Four Operation Program

4. Exit 1 

Press F6  exit key in main menu and enter exiting program Main menu-- Shut down

Prompt

Shut down··   

2 

The circuit washing is done automatically during exiting, system will display shut down  prompt after 4 minutes Main menu-- Shut down 

Prompt

You can turn off power now

3  Turn off the switch and disconnect power.

4- 4 

 

Chapter Five Review Record

Chapter Five

Review Record

Foreword ●

TEK-II Mini Analyzer has perfect function to store information and the storage is 1200 samples in which 100 samples with histograms and 1100 samples without histograms.

All daily results can be stored automatically and the storage can be shown.

●

1. 

3

5- 1 

 

Chapter Five Review Record

Article One

Press

F1 

Review Method 

in main menu to enter into the Record review and the screen displays:

Record review 

Input date:[yy-mm-dd] xxxx-xx-xx

1. Review Method 1 

Input Date: Please input the date inquired and the screen displays:

Record review 

xxxx-xx-xx Total tal test testss xxx xxx  No. range  xxx-xxx Input ID ID xxx

2  Daily total number number Show the the total total number number of of the date 3   No. Range: Original number number and terminative number number of the sample

 

4 ID: Sample number needed to check

1. 

3

5- 2 

 

Chapter Five Review Record

2. Input inquiry number: The screen displays the sample inquiried after confirming the inputted data:

Record Review  NO 001 Item

Result

Unit

WBC RBC HGB HCT MCV MCH MCHC PLT

9.3 4.14 121 0.361 87.1 29.3 336 204

1012/L 10 /L g/L L/L fL pg g/L 109/L

Item

Result

Unit

LY% MONO% GR% LY# MONO# GR# RDW PDW MPV

17.7 3.3 78.9 1.6 0.3 7.3 12.8 14.7 12.8

% % % 109/L 109/L 109/L % % fL

PCT

0.262

L/L

9

Diagram 

5) Display the histogram with “←” and press“→”to back 6) Inquiry sample with “PgUp” and “PgDn”. 7) Press [Print] to print out the result.

Record Review  NO 001 Item WBC RBC HGB HCT MCV MCH MCHC PLT

WBC Result 0.0 0.00 0 0.000 0.0 0.0 0 0

Unit 109/L 1012/L g/L L/L fL pg g/L 109/L

[fl]

0 50 100

300

400

RBC

[fl] 

0

50

100

200

PLT ****-**-** **  **  [fl] 

0 2  5  10

20

30 

 Next Pa e

1. 

3

5- 3 

 

Chapter Six QC of Instrument

Quality Control of Instrument 

Chapter Six

The aim of checking instrument’s quality is to ensure the exact and credible of the data and follow the requirement of clinic, therefore, the instrument must proceed laboratory quality control is necessary to control the quality of the instrument report’ report’ss result. So as to understand the condition of instrument, find out  problems; analyze reasons, reasons, take measure measure decrease and cancel cancel the error in the process of test. There are two following QC methods.  Target QC

●

  Floating average average value

●

Press the quality control key F4 

in main interface and enter the program of quality control, the screen

displays:

QC Target Float

6- 1

 

Chapter Six QC of Instrument

Article One I 

Target QC

Purpose of target QC

The method of target QC is a method of QC with known target value. The QC method can detect the instrument’s precision; at the same time, it can detect the exactness of instrument. Indicate in time whether the calibration index is exact or not and the error of instrument is llarge arge or small.

II 

Figure of Quality Control

Press the  F2 key of target QC QC in the QC interface, interface, the system will enter into into the program program of target Q QC, C, the screen displays:

QC Date  F1 

Target QC 

xx-xx-xx

WBC xx.x xx.x RBC x.xx x.xx PLT xxx xxx HGB xxx xxx MCV xxx.x xxx.x QC

F2 

Modify target  F3 

Log.  F4  :xxxxxx 

Figure of target QC: The tested results are vertical coordinates, the determined times are horizontal coordinates in the figure of target QC, the central position of the vertical axis is target value (  X  ), a line of horizontal target value is drawn from that point. Then four points of up-down limits of the alarming limit of allowable error (target value

±2SD)

and maximum allowable limit (target value

±3SD)

are fixed on the

vertical axis respectively, the four straight lines are drawn from the four points to parallel with the line of target value, which is called alarming boundary line and maximum allowable boundary line respectively.

6- 2

 

Chapter Six QC of Instrument

III 

Implementation of the Target QC Program  

The target value QC is the known target value, please enter the target value firstly before quality control. The target QC should be tested before starting operation every day to affirm whether the instrument’s instrument’s condition is normal or not. Methods: 1. Press

F1  of the target QC in the interface of quality control to enter the program of the target QC.

2. Press F4 

to input input new con consta stant nt value value number number and press press Enter Enter .

3. Press F3  to input new target value of the target substance and move“

←

 

→

”

input target value and SD

va valu luee in the the cur curso sor’ r’ss fram framee an and d th then en p pre ress ss Ente Enterr . 4.Press F2  and aspirator needle move down automatically for test and the screen displays:

QC test 

Testing… 

4.1 Overturn the test tube filled with QC substance for 20 times to mix it fully and evenly. 4.2 Open the lid of test tube and put the tube under the aspirator needle and press the start key. 4.3 The aspirator needle will move up automatically after sucking and then the substance can be moved away. 4.4 The determined determined value in the picture of target target QC is a vertica verticall coordinate after after the system is determined, determined, determined times are horizontal coordinates which draw the point of the quality control and the picture of the quality control. interface. 4.5 Press ESC  to exit the program of target QC and then back to main interface.

. Quality judgment of the Quality Control

All tested values should be in the maximum allowable boundary line in the picture of the quality control, if 6- 3

 

Chapter Six QC of Instrument

the test value exceeds the alarming line but in the maximum allowable boundary line, the test result is valid,  but it means that the error is larger, and please check carefully the target QC substance, reagent, instrument, specimen suction account and the evenly mixed condition of specimen. If tested value exceeds the maximum allowable boundary line, it means that it exceed  exceed  control and the tested result is invalid, and please find out the reasons of causing error, cancel it and test again. The exactness of the determined result, the magnitude and the property of error can be analyzed and decided according to the position of quality control points.

6- 4

 

Chapter Six QC of Instrument

Article Two

Floatin Floating g Average Method

. Purpose of Floating Average Method The  X  B analysis carries out monitoring the determined quality of the instrument through monitoring the stability of the average value of red cell index (MCV, MCH and MCHC) of stochastic specimen group. It is supplemented with the quality control substance but can not replace each other. The Purpose of using the method of floating average value method is to observe the instrument operating condition, control the working precision in laboratory and the consistency of the test between days and  batches while detecting detecting specimens, whether the result can be reported reported exactly and in time. time.

II  Press

Picture of Method of the Floating average value 

F2  floating average value key in the QC interface, the system will enter into the floating average

value program and the screen displays:

Float MCV

MCH

MCHC

The decision of  X  B  target value: Test the stochastic 500 patients continuously with the calibrated hematology analyzer (calibrate the instrument again after determined 100 patients’ specim specimens), ens), and count the average values of red cell index, and the average value is used as the  X  B target value, which should be in the following scopes: MCV 89.5±1.5 (fl) MCH 30.5±0.5 (pg) MCHC 34.0±0.5 (g/dl) The group of patients should be tested continuously for the three parameters MCV MCV,, MCH and MCHC. There are 20 patients in a batch, the QC scope of the floating average value should be set up in 20 days. A horizontal line should be drawn as target value line at the middle of vertical coordinate, the four points of

6- 5

 

Chapter Six QC of Instrument

up-down limit of the alarming boundary of allowable error (target value  boundary (target value

±3SD)

±2SD)

and maximum allowable

are fixed out at the vertical axis respectively, the four straight lines are drawn

from the four points to be paralleled with the line of target value, which are called alarming boundary line and maximum allowable boundary line.

. Quality judgment of the Method of the Floating Average Value   The precondition of  X  B analysis is to guarantee that the specimens tested by instrument is the random sending specimens of comprehensive hospital, shall not be the classified according to the types of diseases. If the  X  B analysis is made on the specimens of the pure groups of newly born babies or chemotherapies, the analyzed result will be out of the control. While the calibrated instrument test the index of red cell , the average value of the MCV, MCH and MCHC is basically kept unchangeable no matter how many the specimens are. The change of the average value of the parameter can be considered to be caused by instrument, reagent, operation and so on but not caused by the change of the patients’ specimens. So the monitoring purpose can be reached through the change of the  patients’ red cell index. With the floating average value QC software, the instrument can count the average value of the MCV MCV,, MCH and MCHC with 20 specimens in one batch. The new counted data of each batch is within the established scope of  X  B target value, which means the condition of instrument is fine. If it exceeds the scope, the instrument will prompt the abnormality of instrument condition, reagent quality and operation. If all the results are in the alarming limit in the picture of the floating average value methods, this means that the tested result is valid. The MCHC is regarded as the most sensitive remark of losing control of the instrument. Once the MCHC value exceeds the alarming limit in the picture of the floating average value, it means that the instrument loses control. However, the MCV and MCH sensitivity is weak than MCHC, it is unnecessary to record the instrument out of control, if the result exceeds 2SD a time. Only when the result exceeds 3% for 3 times or 2%-3% for 5 times continuously, it is necessary to regard the instrument is out of control. The loss of control of MCV and MCH should not be regarded as the fault of instrument carelessly, because the counting holes clog may also cause the loss of control of MCV and MCH, the counting aperture clog can be solved by rinsing.

6- 6

 

Chapter Seven Instrument Maintenance

Chapter Seven Article One Press

F3 

Instrument Maintenance

Instrument Maintenance

in main menu to enter maintenance program, the screen displays:

Maintenance Soak and rinse

Thank you for use T E K -II Mini  Automatic 3-diff Hematology Analyzer

Aperture rinse System diagnosis

Prime reagent Setup

I 

Soak and rinse Pres Presss soak soak and and rin rinse se key key F1 

in main menu to enter the program, the screen displays:

Soak and Rinse 

 

Soak So akin in and and R Rin insi sin n The system is washed perfectly with detergent about 4 minutes. Back to maintenance interface after rinsing.

7-1

 

Chapter Seven Instrument Maintenance

II 

Aperture rinse

Press Pre ss apertu aperture re rin rinse se key F2  in maintenance interface to enter the program of aperture rinse, and the screen displays:

Aperture rinsing 

Please insert the aspirator needle into concentrated detergent then press test  button to start

Put the concentrated detergent under aspirator needle according to the interface and press test key, the aspirator needle will suck about 6ml liquid automatically and wash aperture again and again.

Aperture rinsing 

A erture is rinsin …

Back to maintenance interface after washing and this processing last for about 3 minutes.

7-2

 

Chapter Seven Instrument Maintenance

III 

Diagnosis

Press F3  diagnosis in the maintenance interface to enter the program of diagnosis and then the screen displays: (C refers to Close; U/D refers to Up/Down; L/R refers to Left/Right)

Diagnosis  Valve Ev1  Ev2

Ev3

 C

C

C

Ev4 C

 

Ev5 C

Ev6 C

Ev7 C

C

Ev8

Ev9

C

C

Ev10

Motor  M1  L/R  

Pum  

M2  U/D 

M3 

M4 

U/D 

C  

M5  U/D 

M6  U/D 

M7 O/C 

U/D 

HGB Volt   F5  900

Technic echnician ian No. 0791-8 0791-811 11199 1991 1

Entering the program can check one by one whether the electro-magnetic valve, motor, pump, switch and HGB voltage value of the instrument are normal or not, help the users and the technicians diagnose the operating state of each part of the instrument and to carry out the necessary maintenance .

1. Parts Diagnosis

1) Use Direction Keys to choose choose operating operating target. 2  The 1-10 electro-magnetic electro-magnetic valve valve will carry o out ut the change between On and Off by Pressing “Ente “Enter” r” to check whether it can work normally or not. 3  To check the motor to press “Enter ” to check the function of the motor such as Up and Down, Left and Right. 4  To check the pump to press “Enter” and the screen will display the checking processing of the pump.

 Note: Each part must return return the original position after carrying out diagnosis.

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Chapter Seven Instrument Maintenance

2  HGB Voltage Measurement 1 

Press F5  to confirm the voltage data and the screen will displays the device’s voltage.  Note: The normal normal range of HGB voltage value is 850-950.

3. Diagnosis Exit Press Esc 

and the device will check and recover the working condition of each part automatically.

IV Pr Prim imee reag reagen ents ts Press F4  in the interface of prime reagent to enter the program of prime reagent and then the screen displays:

Prime Reagent Prime Det

Thank you for use T E K -II Mini  Automatic 3-diff Hematology Analyzer

Prime Dil

Prime Lyse

Prime All

xxxx-xx-xx

xx-xx

1) Prime Detergent Press F1  of prime rinse liquid in the maintenance interface and the screen displays:

Prime Det 

Priming 7-4

 

Chapter Seven Instrument Maintenance

Then system enters the processing of piloting rinse liquid and back to maintenance interface after finishing the operation.

2) Prime Diluent Press F2  of prime diluent in maintenance interface and the screen displays:

Priming Diluent 

Primin

 

Then system enters the processing of prime diluent and back to maintenance interface after finishing the operation.

3) Prime Lyse Press F3  of lyse reagent in maintenance interface, and the screen displays:

Prime Lyse

Priming

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Chapter Seven Instrument Maintenance

Then system carry out priming lyse and back to maintenance interfac interfacee after finishing the operation.

4 

Prime All Press  F4  in maintenance interface and the screen displays:

Prime All 

Primin

 

Then system carries out priming detergent,lyse and diluent then back to maintenance interface after finishing the operation.

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Chapter Seven Instrument Maintenance

Article Two

Daily Mainten Maintenance ance

In order to keep instrument in its best state, it is necessary to maintain the instrument periodically.

. Turn On the Instrument After turning on the instrument and the system repeatedly rinses the counting pool, aperture and connecting  pipeline automatically with the diluent, determine the blank of reagent. The normal blank of reagent is the  premise that the instrument can start a day’s day’s normal work..

. Turn Off the Instrument After finishing a day’s measurement, or under the condition of continuously using this instrument, turn off the machine at least once every 24 hours. By turning off the machine, the system automatically rinses the counting pool, aperture and connecting  pipeline with detergent, soak the counting pool and aperture with detergent till turning on the machine next time, this way of rinse can strongly guarantee the cleanliness and smoothness of the testing system.

. Working Working Par Parameter ameter Setup The aim of setup the working parameter is to guarantee that the instrument can automatically maintain during the course of continuous usage. 1) The setup of times of continuous work: Users can set the times of continuous work according to the condition of using the instrument, the instrument will automatically carry out washing aperture once after reaching the set times of continuous work to insure that the instrument is used iin n better state. 2) Spare interval time: Users can set it i t according to the using condition of instrument. Instrument arrives at the time and the system automatically carries out rinsing aperture once, then enter into the reset state to ensure that the instrument stays in  in  hibernate state, and the consumption of energy is reduced. 

. Empty the Waste Liquor Barrel The waste liquor barrel must be periodically emptied to ensure the environment sanitation of instrument, and also ensure the fine operation of the instrument.

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Chapter Seven Instrument Maintenance

Warning  Hazardous and Biohazardous Material  ● 

When disposing of waste,do waste,do not touch them them directly directly,protective ,protective garments and gloves gloves are strongly recommended because they have the danger of potentially biohazardous infection.If accidental contact with waste,immediately flush the affected area with disinfection liquid at first,then wash clearly by soap.

● 

Follow all regulations applicable to your laboratory when operating the TEK.

V. Weekly Mai Maintenance ntenance

1.  Check whether the power source and grounding wire meet the requirement or not. 2.  Carry out once soak and rinse of the instrument or aperture rinse. 3.  Clean the surface of the instrument Use clean and wet cloth to wipe up the surface of the instrument and wipe off the bloodstain in time. Do not wash with chemical reagent or sanding reagent. When rinsing, pull out the power supply plug, and insert the power supply plug after instrument is clean and dry. dry.

VI. Monthly Maintenance-System Maintenance-System Diagnosis

The instrument sets the program of system diagnosis that carries out once system diagnosis of each part every month to ensure that each part of system can normally work.. Press

F3  of system diagnosis in the maintenance interface to enter the program of system diagnosis,

which can check one by one whether the magnetic valve, motor, pump, sensor switch and HGB voltage value of instrument are normal or not, and help users and maintenance technicians to diagnose the working state of each part of instrument to carry out the necessary safeguard and maintenance of instrument in time.

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Chapter Seven Instrument Maintenance

Warning  Direction for electric source wire, connection c onnection and grounding ●Before opening the instrument to maintain its inner part the electric source must firstly be cut off

to prevent it from getting the electric shock or causing troubles. ●When replacing a fuse you should replace the fuse with the same specifications after cutting off

electric source so as to avoid getting electric shock, causing troubles.

Warning Hazardous and Biohazardous Material 

 

All surfaces and components in contact with patient samples should be considered potentially contaminated. Protective garments and gloves are recommended when operating, maintaining, or servicing the TEK.



 

Do not touch the waste when disposing of it or assembling /disassembling associated parts. If If accidental contact with waste , immediately flush the affected area with disinfection liquid at first, then wash clearly by soap.

VII. Necessary Maintenance 1. Maintenance

for Aperture Pipeline

The maintenance program of system sets three cleaning programs of soak and rinse, aperture rinsing and aperture cleaning. In the course of using the instrument, when appears the condition of high blank count, incorrect measured value and bad repetition, and it prompts there might be half blocked aperture or uncleanness of the tested pipeline, clean and maintain aperture and tested pipeline by the above-stated three ways according to the concrete condition.

1). Soak and Rinse

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Chapter Seven Instrument Maintenance

When soak and rinse, system repeatedly soak and rinse the counting pool and related pipeline with 32 ml detergent and 52ml diluent, 4 minutes in total. This program is used when the dirt of the counting pool and related pipeline are difficult to be washed off. 2). Aperture Washing When washing the aperture, system repeatedly rinses the aperture with 6ml concentrated liquor. This  program is specially designed designed for serious blockage blockage of aperture.

2.

The Necessary Maintenance after Replacing Reagent

After replacing reagent, priming the reagent once can prevent inbreathing air when testing to ensure the  precision of tests.

7-10

 

Chapter Seven Instrument Maintenance

Article Three

Setup

Hematology analyzer likes other instruments, must be calibrated with calibration substance of the known and exact value so as to decrease the error of the system, get exact and reliable test result. The calibration should not be done periodically. If the quality control’s data are over the normal condition with time going, the instrument can be calibrated after instrument’s installation or maintenance. Please record carefully after amending each time. Please do not calibrate it, if the abnormal data of the quality control are caused by the disturbance of instrument, degenerative reagent and the quality control substance invalid on expiry. expiry. 1. Methods of Calibration

There are two methods to calibrate the instrument: ● Automatic calibration. ● Manual calibration.

2. Calibration Substance

There are three calibration substances:  ●  Calibration substance of the fresh blood. ●  Stored blood blood and artificial goods. ●  Calibration substance of commodity 3.

Preparation of Calibration Substance 

1  Check whether it is over the deadline or not firstly, firstly, degenerative or polluted or not. 2  Put it for a while after taking it out from fridge, and make it reach the room temperature. 4.

Preparation of Instrument before calibration  

The fine condition of the instrument should be kept before calibration; it can be calibrated when the following conditions are satisfied. 1  Use the qualified reagents, and enough reagents are supplied. 2  The pipeline system of the instrument should be soaked and rinsed, and check whether the blank of the reagents is normal or not. 3  Get a portion of fresh blood from healthy person and test it for 5-10 times, the statistical precision is qualified.

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Chapter Seven Instrument Maintenance

4  Check the carryover rate carried by the instrument, count the carryover rate carried by the instrument to  be qualified or not. Press F5  in maintenance interface to enter the setup program and then the screen displays:

Setup

Calibration

Thank you for use T E K -II Mini  Automatic 3-diff Hematology Analyzer

Range Preference Time Setup

I Calibration  Press  F1  of calibration calibration   in setup interface to enter the calibration program and then the screen displays:

Calibration ●Auto Calibration

Item

●Manual Calibration

Target

Result

Coefficient

WBC RBC PLT HGB MCV MPV

 Note  Please use “←  →” to change while select the calibration method. 

7-12

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Chapter Seven Instrument Maintenance

Range of Calibration Factor ●  WBC

0.5  1.5

●  RBC

0.5  1.5

●  PLT

0.5   1.5

●  HGB

0.5  1.5

●  MCV

0.5  1.5

Note  The system will alarm if the factor is exceeded the setup range and then the change is invalid.

1. Manual Calibration Procedure 1  The manual calibration is applied if the determined result of calibration substance in the device is known and the calibration factor can be calculated manually. 2  Press “←  →” to move cursor and input new factors and then Press “Enter”.

2. The Computation of Manual Calibrated Factors Target value of the calibration substance  New calibrated factor  factor =original calibrated factor × tested value of calibrated substance of the instrument

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Chapter Seven Instrument Maintenance

II Setup of Parameter Range Press F2  of parameter range in set interface and enter the program of parameter range and then the screen displays:

Range Item

min

max

Item

min

max

WBC

04.0

10.0

LY% LY%

20.0

45.0

RBC

3.50

5.50

MID%

02.0

09.0

HGB

110

160

GR%

45.0

75.0

HCT

0.350

0.500

LY  

01.0

03.3

MCV

080.0

100.0

MID

00.2

00.7

MCH

28.0

33.0

GR  

01.8

06.4

MCHC

320

360

RDW-CV

11.5

14.5

100

300

RDW-SD

37

55

PDW

15.5

18.2

MPV

07.0

12.0

PCT

0.100

0.282

PLT PLT

1. Setup Method 1  The parameter range has been set when the device is in factory, but the range is only for reference, so user can set according to different actual condition. 2  Press “←  →” to move the cursor and input the range of the clinic reference value of each parameter with digital key in the frame. 3  Press “Enter” after inputting value, and the system confirms the inputted value. If the setup is not finished, then the set range will not be saved. 4  Press “Cancel” to cancel the calibrate data. 5  Press “ESC” to back to the setup interface.

7 14

 

Chapter Seven Instrument Maintenance

2. General Parameter Range

Item

Range

Unit

WBC

4.0 —10.0

10 /L

LY

1.0—3.3

10 /L

Mid#

0.2—0.7

10 /L

GR#

1.8—6.4

10 /L

LY%

20.0—45.0

Mid%

2.0—9.0

GR%

45.0—75.0

RBC

3.50—5.50

10 /L

HCT

0.35-0.50

L/L

MCV

80-100

fL

MCH

28.0—33.0

Pg

MCHC

320-360

g/L

RDW-CV

11.5—14.5

%

RDW-SD

37--55

fL

HGB

110-160

g/L

PLT PLT

100-300

10 /L

PCT

0.100—0.282

L/L

MPV

7.0-12.0

fL

PDW

15.5-18.2

%

9

9

9

9

12

9

There is a little difference of normal rang setup among different types, users can set the range according to different actual conditions. If the test value is over the reference value value   has been set, “H” will show in the  printing result, if the value is lower, “L” will show in the printing result. result.

7 15

 

Chapter Seven Instrument Maintenance

III Work Work parameters setup Press F3  of working parameter in setup interface to enter the program of working parameter and the screen displays:

Preference Continuous tests

xx 

Idle Time xx  Inst Instru rume ment nt SN xx xxxx xxxx xxxx xx  Ver.  xx.xx.xx  Auto Print  F1  Off   Report + Histogram

F2 

On 

Explanation  1.Continuous 1.Cont inuous tests tests Use digital digital keys to inp input ut numbe numberr in the menu of working working paramete parameter, r, input input “↑19AB

  data  ↓” then “Di, Di,Di” sound will raise for three times, it means that the testing times has reached to the setup times (max. 99 times and min. 01 times). The instrument will prompt automatically whether to clean the aperture or not. If you do not choose, the system will impliedly carry out a aperture wash automatically for one time.  2.Idle Time  Use digital keys to input number in the menu of working parameter, input “↑29AB data  ↓” then “Di, Di,Di” will raise for three times; it means that the waiting times has reached to the setup times (max. 99 h and min. min. 1 h). The instrument instrument will carry out a blank test automatically automatically and exit the test interface after that . number. 3.Instrument SN Original serial number. 4. Ver.: The version number of software and hardware. 5.Au 5.Auto to Pr Prin int: t: Pres Presss F1  to change change the mode; mode; Press Press F1 and the the screen screen displays displays “On”, “On”, and the result result will be be

7 16

 

Chapter Seven Instrument Maintenance

 printed automatically, if Press F1 

again and the screen displays “Off”, the result will not be printed, if

need to print after testing, please Press “Print” . 6.Repo 6.R eport rt + Histog Histogram ram : Press Press F2  to cha change nge the mod mode; e; Pre Press ss F2  and the screen displays “On”, and the device will print out the histogram while print the result, if Press   F2 agai again n the screen screen display displayss ““Off Off”, ”, th thee test result without histogram will be printed out. 7.Report print format:The report print format as below.When the device connected with a computer,there are many formats can be chose.

7-17

 

Chapter Seven Instrument Maintenance

T  D A i   m  a  e   t    g  e   e    *  *  *  *  *    *  *  *  *  *  *  * 

 

H H R  G M L   C  G B   ar   d  i    ym T  B   C  %  %  %        6  1   .2   5   0   .  .4  2   .  0   3   .1   3   5   9   3   3  4   6  4 

A H A n m  u  al    e   t    o  a z   o  t    am  e  r   ol    t   i   r   g  c   e   y  or   t  

 

 S   N  N  e  x  am  o  .    e  *  *  *   

 G M L   W  t   I   r   d  i    ym B   e  m  a#  #  #   C  .2   0   .  5   3 

R  .2   8   .4   e   0   s   u l    t  

1   U 1   0  1   0  1   0   g 1   %  %  %  0  L   /    /   n L  L   0 1 2     9   9   9       /   9   /   i    /    /    t   L  L  L  L   /   L  1   0  1   .  0   3   5   0  1  -  6   0   .  0   5   0   0 

 3   .  5   5   .  5 

4   5   . 0  7   5   .  0 

 .2   0   9   .  0 

 .1   0   .4   aR  0  -1  n  3   g  .  0   e   3 

2   .1   0   .2   8   . 0  -  0   0  -4   6   .4   .7   5   . 0 

 

P  M P  D P   C  W  V T   

 

1   6   . 6 

1   0  1   3  1  2  2   .1   0  7   9   .1   6   .  .  0  1  1   5  2  7 

 

%  

 g  p 1   % f   f   L   0  L   /   L   /   L   g L   /   9    L 

 

1   5   .  5  1   8   .2 

 .7   0  1  2   .  0 

 0   .1   0   0   0   .2   8  2 

P  R L  D T   W  C  V

1   0   0   3   0   0 

  T  L  P  1   0  2   0   3   0 

f   L 

1  1   . 5  -1  4   . 5 

R D  W  S  D

 3   .7   0   5   5   . 0 

   C  B R

M M M  t   I    C  C  C  e  H H  V m  C

2   8   .  0   3   3   . 0 

 

  1   0   0 

1   0   0 

2   0   0 

2   0   0 

4   0   0   

f   L 

 3   0   0 

f   L 

 

 S   N  N  e  x  am  o  .    e  *  *  *   

H H R  G M L   C  G B   ar   d  i    ym T  B   C  %  %  %       1  2   5   0   6  4   . 3   0   .2   5   . 9   .1   . 3   3   6   3  4  4 

 

A HA n m  u  al    e   t    o  a m  t   z   ol    a  e  r   o  t   i   r   g  c   e   y  or   t  

 G M L   W  t   I   i    ym B   e  m  ar   d  #  #  #   C 2   0   . 5   . 3 

2   .4  R  . 0   8   e   s   u l    t  

1   U 1   0  1   0  1   0  1   %  %  %  0  L   g  /   n L   0 1    L   /    9   9   9       9  i   2   /    /    /    /    t   L  L  L  L   /   L  1   0  1   .  0   3   5  -1   0   6   0   . 5   0   0   0 

 3   .  5   5   . 5 

4   5   . 0  -7   5   . 0 

 .2   0   9   . 0 

2  1   0   0   .2   . 0   . 8  -  0  -4   6   .  . 4  7   5   . 0 

4  R  .1   . 0   a  0  -1  n  3   . 3   0   g  e 

 

P  M P  D P   C  W  V T   

 

1   6   . 6 

2  1  2  1   0  1   3  7   9   .1   0   .1   0   .  .  6  1  1   5  2  7 

f   L   U n i    t  

 

%  

f    g 1   % L   p f   L   0  L   /    /   L   g L   /   9    L 

f    U L  n i    t  

 8  R  0   .  an  0  -1   g  e   0   0   .  0 

 

1   5   .  5  -1   8   .2 

7   . 0  -1  2   . 0 

 8  R  0   .  an  0  -1   g  e   0   0   . 0 

 3  R 1   5  2   e   . 9   3   s   .  u  6  l    t  

 3  2   0   3   6   0 

T  D A i   m  a  e   t    g  e   e  *    *  *  *  *    *  *  *  -*  *  -*  * 

 C  B  W  

 0   .1   0   0   0   .2   8  2 

P  R L  D T   W  C  V

1   0   0   3   0   0 

1  1   . 5  1  4   . 5 

R D  W  S  D

 3   .7   0   5   5   . 0 

M M M  t   I    C  C  C  e  H H  V m  C

 3  2   0   3   6   0 

R 1   3  2   e   5   . 9   3   .  s   u  6  l    t  

2   8   .  0   3   3   . 0 

7-18

 

Chapter Seven Instrument Maintenance

IV Time Setup Press F4  time setup key in set interface to enter the program of time setup and the screen displays:

Time Set 

Date ate [yy[yy-mm mm-d -dd] d] xxxx-xx-xx Time  [hh-mm-ss] xx  xx  xx

Note:  The old ones can be replaced automatically automatically,, if input new date and and time. Press “Enter” key to

 back to the setup interface. interface.

7-19

 

Chapter Eight

Chapter Eight

Analysis and Elimination of Tr Troubles oubles

Analysis and Elimination of Troubles

I Background   Trouble 1. 

The

background

of

WBC, RBC and PLT exceed the setup range when

start

the

Reason Analyzing

Ways of Elimination

a.  Aperture or testing pipeline is

a. Carry out the soaking and rinsing program, clean

dirty.

the testing pipeline and aperture of instrument.

 b.  The reagent syringe of lyse leaks

c. Carry out a diluent prime to eliminate the air

gas or has air bubbles. c.  The reagent syringe of diluent

instrument.

 b. Carry out out lyse prime to eeliminate liminate the aair ir bubbles.

 bubbles. d. Insert the pipeline under the liquor surface of

leaks gas or has air bubbles. d.  The pipeline of reagent did not

reagent.

inserted under the liquor surface of

e. Add reagent.

reagent.

f. Replace the unqualified reagent with the qualified

e.  Lack reagent.

reagent.

f.  Reagent is unqualified.

g. Connect well the earth wire of instrument.

g.  The earth wire with ground is in  poor contact. contact.

h. Move away the source of interference.

h.  The instrument is interfered. 2. 

The

test

values

of

WBC, HGB are high at the same time.

a.  The lyse pipeline did not inserted under the liquor surface of lyse.

a.  Insert the pipette of lyse under the surface of liquor.

 b.  Lack of lyse.

 b.  Implement lyse.

c.  EV6 Valve worked abnormal

c.  Rinse or replace the EV6 valve

d.  Lyse nozzle blocked in WBC

d.  Clear block.

counting pool 3. 

The backgrounds of

a.  The aperture of RBC is dirty.

RBC and PLT exceed

 b.  The counting pipe of RBC leaks

the setup range.

a.  Rinsing and wash the aperture.

gas.

c. Carry out a prime diluent to eliminate air bubbles.

c.  The injector of reagent leaks gas. d.  The diluent is unqualified unqualified..

4. 

 b. Connect well well the countin counting g pipe of RBC RBC..

d. Replace the unqualified lyse with qualified diluent.

Only the background

a.  The aperture of WBC is dirty.

a.  Rinsing aperture, and wash the aperture.

of WBC exceeds the

 b.  The lyse is unqualified.

 b.  Replace the unqualified lyse with qualified one.

set range.

c.  The counting pipe of WBC or

c.  Connect well the counting pipe of WBC, carry

reagent syringe leaks gas. d.  M4

injector

reactive.

no

reverse

out a prime lyse to eliminate the air bubbles. pump

d.  Check or replace the M4 injector.

8- 1

 

Chapter Eight

5. Only the background of hemoblast exceeds the setup range.

a.  The earth wire of instrument is in

Analysis and Elimination of Tr Troubles oubles

a.  Reconne Reconnect ct well the earth wire.  b.  Move away the source of interference.

 poor contact. contact.  b.  The instrument is interfered.

c.  Replace the unqualified diluent with qualified one.

c.  The diluent is unqualified unqualified..

d.  Carry out the rinsing program of aperture.

d.  The aperture is dirty.

e.  Replace or resolder the electrode line.

e.  The

electrode

line

of

RBC

counting pool is in poor connected or oxidated. a.  Lack the reagent.

a.  Add reagent, and restart the instrument once.

exceeds the range of

 b.  The testing bulb of HGB burns out.

 b.  Replace the bulb.

850-950.

c.  The

c.  Replace the electric eye.

6. The voltage of HGB

electric

eye

is

aging

or

d.  Replace the TL082 Chip.

damaged. d.  TL082 Chip work badness.

e.  Check relative pipeline

e.  The liquor in counting pool of

f.  Tune up the HGB voltage potentiometer.

WBC is not enough. f.  The voltage excursion.

II Testing Trouble

Reason Analyzing

Ways of Elimination

1. The test value of

a.  The aspirator needle is slightly

a.  Use concentrated detergent as the specimen to do several

WBC is low.

 blocked.

tests repeatedly.

 b.  The aperture of WBC is half

 b.  Carry out cleaning gem aperture to clean it. c.  Enter the program of diagnosis system, repeatedly carry

 blocked. c.  When the capacity of lyse is added

out checking the switch-on and switch-off of the

more, check whether the liquor

electromagnetic valve EV6, observe whether the test can

surface in WBC counting pool is

 be normal or or not.

too higher or not.  

The normal

liquor surface is about 5mm higher than the subm submerg erged ed ape aperture rture..   d. Not revised. revised.

d.  Use QC blood or human being vena blood mirror inspection revise it.

8- 2

 

Chapter Eight

2. The test value of WBC is high.

a.  The end of lyse pipette is not

Analysis and Elimination of Tr Troubles oubles

a.Insert the pipette of lyse under the liquor surface of lyse.

inserted under the liquor surface of

 b.Add the lyse. lyse.

lyse.

c.Carry out the aperture rinsing program.

 b.  The lyse lacks.

d.Replace unqualified lyse with the qualified one.

c.  The aperture of WBC is dirty.

e.Enter into the program of system diagnosis, repeatedly

d.  The lyse is unqualified.

carry out the checking of the switch-on and switch-off of

e.  The proportion of diluent isn’t

electromagnetic valve EV6, observe whether the test is

correct. Check whether the liquor

normal or not.

surface in counting pool is too low. f.  Enter the program of system diagnosis, repeatedly carry

 

The normal liquor surface is

about

5mm

higher

than

out

the

the

checking

of

switch-on

and

switch-off

of

electromagnetic valve EV9 and EV4 observe whether the

submerged aperture. 

test is normal or not.

f.  The testing temperature of the g. Enter the program of system diagnosis, repeatedly carry instrument is low.

out the checking of going up and down of motor M5,

g.  The earth wire doesn’t contact well with ground. h.  The instrument is interfered.

3. The test values of RBC and PLT are low.

a.  The aperture of RBC is half  blocked.  b.  The amount of second sample is not enough. c.  RBC counting pool vent liquor abnormal.

observe whether the test is normal or not. h. 

Increase Incre ase the eenvir nvironm onmenta entall temperatur temperaturee to 15 -30  

i. 

Connect well again the earth wire of instrument.

 j. 

Move away the source of interference.

a.  Carry out the program of aperture and wash aperture.  b.  Entering the program of system diagnosis, repeatedly carry out the checking of going up and down of motor M7, observe whether the test can be normal or not. c.  Entering the program of system diagnosis, repeatedly carry out the checking of the switch-on and switch-off of electromagnetic valve EV7, observe whether the test can  be normal or or not.

a.  Lack of diluent.

a.  Add diluent.

RBC and PLT are

 b.  The aperture of RBC is dirty.

 b. Carry out the cleaning gem aperture, clean the gem

high.

c.  The proportion of diluent is not

aperture

4. The test values of

correct, and check whether the

c. Enter the program of system diagnosis, repeatedly carry

liquor surface in counting pool of

out the checking of switch-on and switch-off of the

RBC is too low or not. (The normal

electromagnetic valve EV9, EV4 and EV5, observe whether

liquor surface is about 5mm higher

the test can be normal or not .and carry out the checking of

the sub subme merg rged ed aaper pertur ture. e.

going up and down of the motor M5, observe whether the

d.  The earth wire of instrument doesn’t contact well. e.  The instrument is interfered.

test can be normal or not. d.  Connect well the earth wire again. e.  Move away the source of interference.

8- 3

 

Chapter Eight

5. The test values of

Analysis and Elimination of Tr Troubles oubles

a. Lack of diluent.

a. Replenish the diluent.

RBC and HGB are

 b. The placeme placement nt of diluent is too

 b. Heighten the place of d diluent iluent and th thee level of instru instrument. ment.

abnormal.

low.

c. Entering the program of system diagnosis, test whether

c. The voltage of HGB is abnormal.

HGB voltage is between 850-950 or not. otherwise, tune up the HGB voltage potentiometer.

6. The test value of HGB is zero or unstable.

a. The test voltage of HGB is abnormal.

a. Replace the luminotron of HGB and electric eye.  b. Carry out soaking and rinsing once, clean the counting

 b. The counting counting po pool ol of WBC is d dirty. irty.  pool of WBC. WBC. c. The lyse is unqualified.

c. Enter the program of diagnosis, repeatedly carry out the

d. The liquor drainage in counting

checking

 pool of WBC WBC is not better better..

electromagnetic valve. and carry out the checking of going

of

switch-on

and

switch-off

of

EV6

up and down of the motor M5. d. Enter the program of diagnosis, repeatedly carry out the checking

of

switch-on

and

switch-off

of

EV5

electromagnetic valve. 7. The test values of WBC, PLT

RBC are

and

normal,

a. The voltage of HGB is checked to

a. Replace the luminotron of HGB.

 be abnormal. abnormal.

 b. Carry out soaking and rinsing once, clean the counting

 b. The counting counting po pool ol of WBC is d dirty. irty.  pool of WBC. WBC.

the rest test value displays zero. 8. The test values of

a. The proportion of diluent is not

a.  Enter the program of system diagnosis, repeatedly check

WBC,

RBC

and

correct, check whether the liquor

the switch-on and switch-off of the electromagnetic valve

PLT

are

all

surfaces in two counting pools of

EV9, EV8, EV4, EV5 and EV7, observe whether the test

 blood cell are abnorma abnormall or not.

can be normal or not. Entering the program of system

  The normal liquor surface is

diagnosis, repeatedly carry out the checking of going up

about

and down of motor M5, observe whether the test can be

unstable.

5mm

higher

than

the

normal or not.

subme sub merg rged ed g gem em ap apert erture ure..  b. The counting counting time is u unstable. nstable.

 b.  Check whether the counting syringe works normally or not.

c. The aperture is dirty. d. The earth wire of instrument falls

c.  Carry out the program of aperture wash, and wash the aperture.

off. e. The instrument is interfered.

d.  Connect well the earth wire again. e. 

Move away the source of interference.

8- 4

 

Chapter Eight

9. The test value of PLT is high and

a.  The aperture of RBC is half

a.  Carry out the program of aperture wash and wash the aperture.

 blocked.  b.  The earth wire of instrument does

unstable.

Analysis and Elimination of Tr Troubles oubles

 b.  Connect well the earth wire of instrument. c.  Move away the source of interference.

not contact well.

d.  Resolder or replace the electrode line.

c.  The instrument is interfered. d.  The electrode line of counting  pool is not connected connected or oxidated 10. The test values of RBC

and

hemoblast are all

a.  The aperture of RBC is blocked.

a.  Wash the aperture.

 b.  The connecting pipe of counting

 b.  Connect well the counting pipeline. c.  Repeatedly carry out the checking of going up and down

syringe of RBC falls off. c.  The active of the second absorbing

zero.

of motor M2.

sample is abnormal. 11. The test value of WBC is zero.

a.  The aperture of WBC is blocked.

a. Wash the aperture

 b.  The connecting pipe of counting

 b. Connect well well the countin counting g pipeline.

syringe falls off. 12. Aspirator needle doesn’t

 b.  The pipe of specimen sucking leaks

suck

the

or

the

gas.

sucked specimen is

c.  The

specimen

not enough.

a.  Using the rinse liquid instead of specimen, continuously

a.  The Aspirator needle is blocked.

determine several times.  b.  Check the leaking part and connect well the related

aspirator

completely

needle

insert

doesn’t

into

the

 pipeline. Check whether the upper end of connecting pipe of aspirator needle falls off or not. c.  Do correct operation of specimen suction.

specimen. d.  M4 motor can not work normally.

d. Entering the program of diagnosis, repeatedly carry out the checking of going up and down of motor M4, observe whether the specimen suction can be normal or not.

III

Drainage. Trouble

Reason

Ways of Elimination

8- 5

 

Chapter Eight

1.The liquor in counting  pool of WBC can not be drained completely.

a.  The electromagnetic valveEV5 can not work normally.  b.  The pump of liquor drainage can not work normally.

Analysis and Elimination of Tr Troubles oubles

a.  Entering

the

program,

repeatedly

carry

out

checking switch-on and switch-off of valve EV5, observe whether the liquor drainage can be normal or not.  b.  Entering the program of diagnosis, repeatedly carry out checking switch-on and switch-off of  pump of liquor drainage, observe whether the liquor drainage can be normal or not.

2. The liquor in counting  pool of RBC can not be drained completely.

a.  The electromagnetic valveEV7 can not work normally.  b.  The pump of liquor drainage can not work normally.

a.  Entering the program of diagnosis, repeatedly carry out checking switch-on and switch-off of valve EV7, observe whether the liquor drainage can be normal or not.  b.  Entering the program of diagnosis, repeatedly carry out checking switch-on and switch-off of  pump of liquor drainage, observe whether the liquor drainage can be normal switch-on and switch-off.

3. WBC, counting pool of RBC and waste liquor can

not

be

drained

completely at the same time.

a. The pump of liquor drainage can not work normally.  b. The electromag electromagnetic netic valve EV5 or EV7 can not work normally. c. Buffer bottle leaks gas.

a.  Entering the program of diagnosis, repeatedly carry out checking switch-on and switch-off of  pump of liquor drainage, observe whether the liquor drainage can be normal or not.  b.  Entering the program of diagnosis, repeatedly carry out checking switch-on and switch-off of valve EV5 and EV7, observe whether the liquor drainage can be normal or not. c.  Check the buffer bottle.

IV Feeding Trouble 

Reason

Ways of Elimination 

8- 6

 

Chapter Eight

1. The liquor can not enter into the counting pool.

a.  The reagent pipette doesn’t insert under the surface of reagent

Analysis and Elimination of Tr Troubles oubles

a.  Insert the reagent pipette under the surface of reagent liquor.  b.  Supplement the reagent.

liquor.  b.  Lack of reagents. c.  The reagent syringe can not work normally.

c.  Entering the program of diagnosis, repeatedly carry out checking going up and down of motor M5 and M7, observe whether the liquor can normally enter

d.  Electromagnetic valve EV9 can not normally open and close. e.  The liquor pipeline falls off.

into or not. d.  Entering the program of diagnosis, repeatedly carry out checking the switch-on and switch-off of the valve EV9, EV4 and EV8, observe whether the liquor can normally enter into or not. e.  Check the pipeline that is fallen off, and connect it well again.

2. The liquor can not enter the counting pool of

a.  The electromagnetic valve can not work normally.  b.  EV5 on the bottom of counting

WBC.

 pool of WBC can not work normally.

a.  Entering the program of diagnosis, repeatedly carry out checking the switch-on and switch-off of valve EV4, EV8 and EV9, observe whether the liquor can normally enter into or not.  b.  Entering the program of diagnosis, repeatedly carry out checking the switch-on and switch-off of valve EV5, observe whether the liquor can normally enter into or not.

3. The liquor can not enter the counting pool of

a.  The electromagnetic valve can not work normally.  b.  EV7 on the bottom of counting

RBC.

 pool of RBC can not work

a.  Entering the program of diagnosis, repeatedly carry out checking the switch-on and switch-off of valve EV4, EV8 and EV9, observe whether the liquor can normally enter into or not.  b.  Entering the program of diagnosis, repeatedly carry

normally.

out checking the switch-on and switch-off of valve EV7, observe whether the liquor can normally enter into or not.

V Alarm Alarm

Reason

Ways of Elimination

8- 7

 

Chapter Eight

1. M1 or M2 can not move to the position.

a. The motor can not move to the

Analysis and Elimination of Tr Troubles oubles

a. Readjust or lubricate.

 position or the resistance of motion  b. Power supply wiring of motor falls off or the motor is big.

is damaged.

 b. The motor motor can not wo work. rk. c. Photoelectricity transducer or

c. Check whether the photoelectricity or the jiggle switch is failure.

 jiggle switch troubles. troubles. 2. M3 can not move to the  position.

a. The motor can not move to the

a. Readjust or lubricate.

 position or the resistance of motion  b. Power supply wiring of motor falls off or the motor is big.

is damaged.

 b. The motor motor can not wo work. rk.

c. Check whether the photoelectricity is failure.

c.Photoelectricity c.Photoelec tricity transducer trouble 3. M4 can not move to the  position.

a. The motor can not move to the

a. Readjust or lubricate.

 position or the resistance of motion  b. Power supply wiring of motor falls off or the motor is big.

is damaged.

 b. The motor motor can not wo work. rk.

c. Check whether the photoelectricity is failure.

c.Photoelectricity c.Photoelec tricity transducer trouble 4. M5 can not move to the  position.

a. The motor can not move to the

a. Readjust or lubricate.

 position or the the resistance iiss large.

 b. Power supply wiring of motor falls off or the motor

 b. The motor motor can not wo work. rk.

is damaged.

c.Photoelectricity c.Photoelec tricity transducer trouble

c. Check whether the photoelectricity transducer is failure.

5. M7 can not move to the  position.

a. The motor can not move to the

a. Readjust or lubricate.

 position or the the resistance iiss large.

 b. Power supply wiring of motor falls off or the motor

 b. The motor motor can not wo work. rk.

is damaged.

c.Photoelectricity c.Photoelec tricity transducer trouble

c. Check whether the photoelectricity transducer is failure.

VI Printing Trouble  1.Do

not print 

Analyse  a.

The installation of print-paper is

wrong. b. Not

VII

Display

Ways Wa ys of Elimination  a. Reinstall the print-paper.  b. Install print-paper print-paper

enough paper. 

8- 8

 

Chapter Eight

Trouble  1. Blue screen

Analyse  a.

The potentiometer not be tuned

Analysis and Elimination of Tr Troubles oubles

Ways Wa ys of Elimination  a. Tune up the potentiometer to the correct position.

up to the proper position. 

Note:

The troubles troubles explained in this instructions instructions can be eliminated eliminated according to the instructions  as for

the unmentioned troubles in the instruction, please contact our company or the agents.

8- 9

 

Reference I Online Application Software Instruction

Reference I TEK-II MINI Online Application Software Instruction

Article One I. 

Installation Instruction

Hardware requirement OS: Win98.Win me. Win Xp operating system. Disk: bigger than a partition symbol. Hardware: CPU 200MHz or higher, Memory 64MB or higher, HDD space: Higher than 50MB (Note: The storage amount of testing data is directly effected by the HDD space. )

II. 

CD Installation

1.  win98.winme OS a)  Run setup.exe program in “Accessories” folder firstly. It maybe appears the prompt:” Whether replace it” when starting install this program. Please click “No”. If it appears “Ignore”, Please click “Ignore”.  b)  Run setup.exe in “Installation package” 2.  winxp OS Run setup.exe in “Installation package”. III Steps before using.

Please

make

sure

there

is

“Mini_sy.MDB”

in

“C:\PC_M\PC_M_D\DATA”.Notice

the

capitalization or not. Sometimes the form of “Mini_sy.MDB” will be changed into opposite word format when finished installing this program in some OS. If it be changed, please modify the name into “Mini_sy.MDB”. If it doesn’t work yet, please copy “PC_M” into “C:” partition root directory(not recommend). But the files propertys in “PC_M” folder needed to be changed after copying finished. Modify the read only property into written. There are 90 days trial after installation. The “Hospital name” in “work parameters” can be revised so as to use more convenience. It is needed to inform the distributor the “Hospital name” in “work  patameters” firstly when when you want to register this program. Dealer w will ill give you a validation code. Then this program can be used directly after entering this code into “work parameters”. Otherwise it can’t work when exceeded the trial time.  NOTICE: The hospital name can’t be changed informally. informally. Otherwise this grogram can’t be run normally.

TECOM

CHINA

 

Reference I Online Application Software Instruction

IV Edition Instruction You can obtain the software edition from “Work Parameters”. Different edition match different object.

TECOM

CHINA

 

Reference I Online Application Software Instruction

Article Two

Software Instructi Instruction on

Double click the icon of application. You can see the login frame. Then login the main menu after enter the user name and password. I. Data Receiving

Click the receiving key in main menu(or press F3),then the testing interface comes out.. Start test the specimen after enter the samples data. The Screen prompt receiving data after test complete. Te Test st result can be shown on the screen about 3 seconds later. Click print button(or press F4) to print the result. Attention: Computer only get the data which being tested and get it when the device and computer both in test program interface. Otherwise the result can’t be received. II Assay Form Edit

Click the assay form edit button in main menu (or press F5).Enter in edit interface. Click add button. Then the samples data can be edited. III Data Maintenance

Click data maintenance button in main menu.(or press F5),Enter in Data Maintenance interface. Delete data according to your demand.(The data on 00.01.01 and intraday time can’t be deleted). Data will show error when power cut off or abnormally shut down. It can be repaired by selected. IV Setup

Click setup button in Main Menu(or press F6),Enter in setup interface. This menu include: Pa rameter Range, Work Work Parameter, Parameter, Print Print Setup, User Setup, Doctor Setup, Dept. Setup. 1.Parameter Range: This function is about various parameter range of blood in human body. 2.Work Parameter: Include Hospital Name, Installation validation code, Print Setup, Time Setup and Edition information. 3.Print Setup: Include various print format, chose by user. 4.User Setup: Can add and delete user account in this item. But only superpower user can change. 5.Doctor Setup: Can add and delete doctor’s name. 6.Dept. Setup: Can add and delete department name. V Record Inquiry

Click Record Inquiry button in Main Menu (or press F7).In Record Inquiry menu. enter the inquiry date or patient name according to the samples for searching. All information received  by computer can be searched searched in this record. record. VI QC

Details in Chapter Six.(This application added non-target QC).The device test QC substance in Te Test st interface. Data can be received only by computer shows the test interface and at the meantime

TECOM

CHINA

 

Reference I Online Application Software Instruction

the operator click the QC button. VII Change Password.

User can change the login password according to demand.

VIII Exit  Click Exit, interface prompt confirm frame. Click Yes to exit. Click Cancel to enter in login

interface. So that another doctor can login. Uninstall the application

Find Online program in Start Menu, then click the Uninstall button.it can be uninstalled.

TECOM

CHINA

 

 

Reference II

Reference II

Communication Protocol

(Note: Suit for TEK-II MINI 1.11 or higher edition)  

Hardware connection: use direct series line to connect (2 pin to 2 pin,3 pin to 3 pin)

 

Series port setup: 19200,n,8,1

1.

2.

 

3.

Communications “

”

Contact Character ‘U’ Within 150ms PC send back ‘S’ available. Separate data with #   ‘8’ Item 18 ,‘9’Item 19. Use other number for future expanding

Item Type ‘8’(or‘9’) #

 Number

***#

WBC Histogram

125 **#

RBC Histogram

125 **#

PLT PLT Histog Histogram ram

125 **#

18 or 19 Items data

See data format below

Testing data

ASCII Code

 No.

Item

Format reference to form as below. Transportation Instruction Data format All be ASCII code. Cancel 0 on higher digit.* is for

1

WBC

***.*# number ASC II code.

2

RBC

**.**#

3

HGB

****#

4

HCT

*.***#

5

MCV

***.*#

6

MCH

**.*#

7

MCHC

****#

8

PLT PL T

****#

9

LY%

**.*#

10

MID%

**.*#

11

GR%

**.*#

12

LY#

***.*#

13

MID#

***.*#

14

GR#

***.*#

 

 

Reference II

15

RDW-CV

**.*#

16

RDW-SD

**.*#

17

MPV

**.*#

18

PCT

*.***#

19

PDW

**.*#

20

Undetermined

Undetermined

 No.

Item

Undetermined

Transportation Instruction Data Format 21

Undetermined

Undetermined

Undetermined

22

Undetermined

Undetermined

Undetermined

23

Undetermined

Undetermined

Undetermined

24

Undetermined

Undetermined

Undetermined

25

Undetermined

Undetermined

Undetermined

 



Send three character @@@ when completed

 

 

Index

Index

A Aperture Rinse…………………………………………………………………………………7-2 Analysis and Elimination of Troubles…………………………………………………………8-1 Alarm………………………………………………………………………………………… 8-7

B ……………………………………………………………………………………8-1 Background ……………………………………………………………………………………

Basic Parameters of Instrument………………………………………………………………2-4

C Check before Testing…………………………………………………………………………4-1 Connection of pipeline…………………………………………………………………………1-2 …………………………………………………………………………3-2 Calculation Parameter …………………………………………………………………………

Calibration………………………………………………………………………………………7-12 Calculation of WBC classification………………………………………………………………3-6 Counting Principle of Blood Cell………………………………………………………………3-1 Collection of Specimens…………………………………………………………………………3-7 Collection and Measurement of Specimens

……………………………………………………3-7

D Drainage…………………………………………………………………………………………8-5 Daily Operation…………………………………………………………………………………4-1 Daily Maintenance………………………………………………………………………………7-7 Diagnosis…………………………………………………………………………………………7-3 Diagnosis and Exit………………………………………………………………………………7-4 Testing of Specimen………………………………………………………………………………3-8

E Empty the Waste Liquor Barrel…………………………………………………………………7-7 Establishment of WBC Classification…………………………………………………………3-6 Environment of Instrument……………………………………………………………………4

F Film Keyboard instruction………………………………………………………………………2-6 Feeding……………………………………………………………………………………………8-6 Figure of QC……………………………………………………………………………………6-2

 

 

Index

G General Instruction……………………………………………………………………………2-2 Grounding………………………………………………………………………………………1-1 General Outline of Instrument…………………………………………………………………2-1 General Parameter Range Supplied by Device…………………………………………………7-15

H HGB Voltage Measurement………………………………………………………………………7-4

I Installation

………………………………………………………………………………………1-1

 

Implementation of the Target QC’s Program……………………………………………………6-3

Introduction………………………………………………………………………………………2-1 Inspection Principle………………………………………………………………………………3-1 Introduction of Fluid System……………………………………………………………………3-5 Introduction of technological process……………………………………………………………3-5 Instrument Maintenance…………………………………………………………………………7-1 In Main Menu……………………………………………………………………………………2-6

M Menu of Tree Structure…………………………………………………………………………2-5 Methods of Calibration…………………………………………………………………………7-11 Monthly Maintenance……………………………………………………………………………7-8 Main interface……………………………………………………………………………………2-6

N  Necessary Maintenance Maintenance…………………………………………………………………………7-9

O Operating Program………………………………………………………………………………4-1 Operating Interface………………………………………………………………………………2-6

P Parameter Calibration…………………………………………………………………………7-14 Parameter Range Setup………………………………………………………………………7-14 Parameter Instruction…………………………………………………………………………2-4 …………………………………………………………………………………………1-2 Printer …………………………………………………………………………………………

Power Regulate…………………………………………………………………………………1-1 Purpose of Target QC…………………………………………………………………………6-2 Picture of Method of the Floating average value………………………………………………6-5

 

 

Index

………………………………………………6-5 Purpose of Floating Average Value Method ………………………………………………

Pipeline Diagram…………………………………………………………………………3-11 Prime all……………………………………………………………………………………7-6 Prime Detergent……………………………………………………………………………7-4 Prime Lyse…………………………………………………………………………………7-5 Prime reagent………………………………………………………………………………7-4 Performancess of Instrument………………………………………………………………2-4 Performance

Q Quality Judgement of the Method of the Floating Average Value ………………………… 6-6 Quality Control of Instrument………………………………………………………………6-1 Quality Judgment of the Quality Control……………………………………………………6-3

R Record review………………………………………………………………………………5-1 Resistance Protecting Principle……………………………………………………………3-1 Reagent,QC substance and Standard Substance……………………………………………2-7 Reagent pack and deadline…………………………………………………………………2-10

S Safe for use

………………………………………………………………………………5

Shut down…………………………………………………………………………………4-4 Soak and Rinse……………………………………………………………………………7-1 Starting the machine………………………………………………………………………4-1 Samples Testing……………………………………………………………………………4-1 Setup………………………………………………………………………………………7-11 Structure of External Part…………………………………………………………………3-10 Setup of Calibration…………………………………………………………………………7-12

T Time setup…………………………………………………………………………………7-19 Test…………………………………………………………………………………………4-3 Testing Program……………………………………………………………………………4-3 Testing Interface……………………………………………………………………………2-7 Target Tar get QC Q C……………………………………………………………………………………6-2 Testing………………………………………………………………………………………8-2 The permissive blank value of reagent………………………………………………………2-11 The testing of HGB……………………………………………………………………………3-2

 

 

Index

W Way of Inquiry………………………………………………………………………………5-3 Work Parameter setup………………………………………………………………………7-16 Weekly Maintenance…………………………………………………………………………7-8

 

 

Product name  Full auto 3-diff hematology analyzer  Model  TEK-II MINI

Tecom Science Corporation #555

Gaoxin

Ave.

National

Hi-tech

Industry

Jiangxi,P Jiangxi, P.R.China

Development

Zone,

Nanchang  

Post code  330096

Shanghai International Holding Corp.GmbH(Europe) Eiffestrasse 80,20537 HHamburg Germany

In vitro diagnostic medical device Tel  0791-8110293 [email protected]   E-mail   [email protected]

Fax  0791-8109407

0791-8111989

http://www.tecom-cn.com