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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

● Chapter Three Inspection 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 Troubles

● 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 manual carefully before using, and conduct the operation 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 all special fittings setting (sell separately).If you have not
purchased this kind of special fittings setting, please jump over this contents when reading this
operation manual.
● This instrument is only used for whole blood cell inspection analyzing, it may not work
normally except for this purpose.
● Please read illumination before using this instrument, and use it under knowing well this
illumination situation.
● Please operate this instrument under the management of engineers who have well trained by
training company pointed by Tecom.
● Please check whether this instrument can work normally by testing QC material when using
this instrument, incorrect testing result may cause wrong diagnosis.
● Do not disassemble or reassemble the unit 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 indicated in user’s manual because it is possible to cause the
damage to instrument.
● Exporting the test result is recommended. That is for prevent the storage history data lost
because of the instrument failure.
● The approved technicians by Tecom conduct assembling, augmenting, reassembling,
improving and repairing the equipments. Otherwise, Tecom will not responsible for it.

I. I
Copyright and declaration
Tecom Science Corporation has the copyright of this unpublicized manual and has the 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 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.

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 (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.
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.
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.
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 within ±2 during testing process.
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.
10. No acute change for power supply. (within AC220V±10%)
11. No near strong electro-magnetic disturbance (centrifuge, discharge device etc.)
12. There is sole grounding 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 instrument should stored within -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 meaning measure

О
Alternating current shut 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, 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,
dangers. There would do harm to human beings You should wear the standard
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
government.
Warning
Some substances (samples, substance of quality
control, standard substance, waste liquor)have
potential bio-infective 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.

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 electric source plug into the appointed outlet.

Otherwise will causes fire accident or getting electric shock.

● When installing the instrument, the electric source or 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 wire so as to cause short circuit or 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 the peripheral fixings(such as printer or barcode scanner),it is 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 a fuse, you should replace the fuse with the same specifications 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 when operating, maintaining, or

servicing TEK-II MINI. Obey the lab safety operate regulation.

● Do not 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 by the blood or waste liquor, immediately wash with sterilized liquor and

then rinse with clean water, and follow the doctor’s instructions.

● Take more care when dealing with samples, must put on rubber 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 with the waste liquor, do not touch waste liquor 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 obligation to follow all the related regulations regarding the release of

waste liquid in the local district or country.

Warning

I. X
Reagent using notice:

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

Instructions.

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

and sick.

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

water immediately.

Attention

I. XI
Direction for matched reagent:

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

● Do not use overdue reagents.

● In the process of replacing and applying reagent, care 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 and

components with original package.

● Do not let anyone who doesn’t understand the instrument 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 is trouble with the instrument, please contact our company or our distributors. Our

company is responsible for repairing it. The guarantee period is shown in the contract.

● In case there is other problem with the instrument, please read the Chapter Eight of this

Operation Instruction Manual carefully. The person in charge of the instrument should

deal with the problem. If 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 is far from the strong electro-magnetic disturbance.

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

● Do not suffer strong shock or strike.

I. 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.


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 source plug into the appointed outlet.

Otherwise it will cause the fire accident or get electric shock.

● When installing the instrument, the electric source or 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.

● 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 Paper outlet
Front Plate LF Key Papering Axe

Transparent Indicator
Window Light Clip trough

Get the front plate down from the printer by moving the front plate forth with 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, 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

Chapter Two Introduction

Article One 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 Analyzer 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
Quantity of white blood cells WBC 109/L
blood
Value of lymphocyte group LY# Absolute value of lymphocyte group 109/L
Value of intermediate cell
MID# Absolute value of intermediate cell group 109/L
group
Value of granulocyte group GR# Absolute value of granulocyte group 109/L
The percentage of lymphocyte The ratio of lymphocyte group relative to white
LY% %
group blood cell quantity
The percentage of intermediate The ratio of intermediate cell group relative to
MID% %
cell group white cell quantity
The percentage of granulocyte The ratio of granulocyte group relative to white
GR% %
group blood cell quantity
Quantity of red blood cell RBC Quantity of red blood cell in each litre of blood 1012/L
Specific volume of red blood Specific value of the volume occupied by red
HCT L/L
cell blood cell in each litre of blood
Average volume of red blood
MCV Average volume of red blood cell in blood fL
cell
Average hemoglobin value of Average quantity of hemoglobin contained in
MCH pg
red blood cell each red blood cell
Average concentration of Average concentration of hemoglobin of red
MCHC g/L
hemoglobin of red blood cell blood cell
When the peak value of distribution curve of red
Coefficient variation of
blood cell grain size is 100%, the HGB
distribution width of red blood RDW-CV %
distribution width of red blood cell is calculated
cell volume
from 68.26% points of whole area
When the peak value of distribution curve of red
Standard Difference of
blood cell grain size is 100%,the HGB
distribution width of red blood RDW-SD fL
distribution width of red blood cell is 20% points
cell volume
from below
Content of hemoglobin HGB The quantity of hemoglobin in each litre of blood g/L

Quantity of thrombocyte PLT Quantity of thrombocyte in each litre of blood 109/L


Specific volume of The specific value of volume occupied by
PCT L/L
thrombocyte thrombocyte in each litre of blood
Average volume of
MPV The average volume of thrombocyte in blood fL
thrombocyte

2-2
Chapter Two Introduction

When the peak value of distribution curve of


Distribution width of thrombocyte grain size is 100%,the distribution
PDW
thrombocyte volume width of thrombocyte is calculated from 68.26%
points of whole area.
● White Blood Cell Histogram

After adding the hemolytic reagent, the range of the white blood cell volume is 35—400fl

100 200 300 400 fl

● Red Blood Cell Histogram

The range of the red blood cell is 25—250 fl

100 200 250 fl

● Platelet Histogram

The range of the thrombocyte is: 2—20fl

10 20 30 fl

2-3
Chapter Two Introduction

IV Basic Parameters of Instrument


Dimensions of aperture WBC 80μm diameter

RBC 80μm diameter

Dilution proportion whole blood: WBC/HGB 1 251

RBC/PLT 1 50000

Sample quantity Whole blood 20μl

Category of sample EDTA sylvite anti-freezing venous blood

or tip 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 interface

Display Dimensions 320×240 LCD

Data input English Version

Working temperature 15 -30

Fuse Φ5×20(mm) T1A 250V

Air pressure range 70.0kpa 106.0kpa

Storage temperature -10 55

Working relative humidity ≤90

Storage relative humidity ≤95

Volume 370mm×275mm×400mm

Net Weight about 12.5Kg

V. Performances of Instrument

PLT
Item Linearity Rel≥0.99
ative Coefficient r
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
F1 7 8 9 ESC
Thank you for use Testing
T E K -II Mini Analyzer F2 4 5 6 PgU
Automatic 3-diff Maintenan
Hematology Analyzer F3 1 2 3 PgD

QC
F4 0 PRI YES
Shut
F5 NO
xxxx-xx-xx xx-xx-xx

2.Key Explanation

Name Function

F1~F5 For the selection of function menu of each interface

0~9 For the input of sample 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 For the determination of setted data, function keys, etc.

Cancel/Delete For deletion of setting data

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

3. Explanation

Record review Press F1 to enter the program to inquire record.

Testing Press F2 to enter the testing program.

Maintenance Press F3 to enter the maintenance program.

QC Press F4 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 Result Unit Item Result Unit
WBC 0.0 10^9/L LY% 0.0 %
RBC 0.00 10^12/L MID% 0.0 %
HGB 0 g/L GR% 0.0 %
HCT 0.000 L/L LY# 0.0 10^9/L
MCV 0.00 fL MID# 0.0 10^9/L
MCH 0.00 pg GR# 0.0 10^9/L
MCHC 0 g/L RDW-CV 0.0 %
PLT 0 10^9/L RDW-SD 0.0 fL
PDW 0.0 %
MPV 0.0 fL
PCT 0.000 L/L
Histogram ID. Set F2

Result Testing value of sample parameter

Press“ ” to enter histogram

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

the original one.

Test result value


NO 001 WBC
Item Result Unit
WBC 0.0 109/L
RBC 0.00 1012/L [fl]
HGB 0 g/L 0 50 100 300 400
HCT 0.000 L/L RBC
MCV 0.0 fL
MCH 0.0 pg
MCHC 0 g/L [fl]
PLT 0 109/L 0 50 100 200
PLT

[fl]
0 2 5 10 20 30
Next Page

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 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 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 into eyes by mistake, shall rinse with volumes of water promptly and

see doctor immediately.

● In case of taking by mistake, shall call for doctor immediately and meanwhile drink

volumes of water and chunk up it.

● In case of stain on hands or skin, shall rinse with volumes of water 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 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 gloves when operating maintenance and inspection and abide

the lab safety operation regulations.

● Do NOT touch the waste these materials(sample, reagent, QC substance, 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 disinfect liquor, then flush with clean

water, and see doctor to deal with it.

● Pay more attention to that you shall wear rubber glove when deal 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 Dosage

About550
Diluent 20L/bucket
samples/20L
Lyse About950
1L/bottle
samples/1L
Detergent 5/L bucket or About
1/L bottle 60-100mL/day

Note: 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 does not contain cyanide.
2) Storage condition of reagent must according to the explanations on its label.
3) The reagent must be used in the normal temperature from 15 to 30 .
4) 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 shouldn’t mix with reagent.

● In the process of replacing and applying reagent, care that the bubble should not be

produced in it.

● DO Not use the reagent exceed the deadline.

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

● DO NOT take it by mistake.

IV. The permissive blank value of reagent

● WBC ≤0.3×109/L

● RBC ≤0.02×10 12/L

● HGB ≤1g/L

● PLT ≤10×10 9/L

2-11
Chapter Three Principle

Chapter Three Principle


Article One Counting Principle of Blood Cell

I. 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

II. The testing of HGB


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 MCV fL ×RBC 1012/L ×10 1

2. The MCH is automatically calculated using the instrument’s RBC and HGB measurement

data. The computations is performed using the follow equation:


HGB g/L ×1012
MCH pg ──────────────-
RBC 1012/L

3. The MCHC is automatically calculated using the HGB RBC and MCV. The computations

is performed using the follow equation


HGB g/L
MCHC g/L ─────────────×103
RBC 1012/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%
L2+L1

68.26% the total area


of granularity

L1 L2

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

MPV

PCT MPV fL ×PLT 109/L ×10 1

6. 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:

lymphocytes group; mainly lymphocyte; mid-size cell group; mainly monocytes cell, eosinophils,

basophils, Neutrophilic granulocyte group: mainly 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 of white blood cell decrease 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 these will cause abnormal to the test of 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.

1.
3-4
Chapter Three Principle

Article Two Introduction of Fluid System

. The flow diagram of fluid system of whole blood mode

5mL
The counting pool of
Diluent RBC The count of RBC, PLT

3mL
25μL
The counting pool of
WBC The count of WBC
3.015mL
1mL

Automatic aspirate The colorimetric


20ul Lyse determination of HGB

II. Introduction of technological process


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 out according to the principle of 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 D2

50 100 200 300 400 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 lymphocytes 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%
LY# + MID# + GR#
2. The calculation formula of the proportion of intermediate cell group is as follows:
MID #
MID% = ──────────×100%
LY# + MID# + GR#

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


GR#
GR% = ─────────×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-K2 or EDTA-K3.
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 materials (sample, reagent, QC substance, 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 disinfect liquor, then flush with clean

water, and see doctor to deal with it.

● Pay more attention to that you shall wear rubber glove when deal 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.

1.
3-7
Chapter Three Principle

II. 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 key (see Fig.2)
4. After the aspirator tip rises automatically, move the specimen away.

Fig.1 Fig. 2 Fig. 3

1.
3-8
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

Structure of External 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 USB(Expand) Connect equipments like printer, etc..

Scanner Interface(Expand):Connect Barcode Scanner.

Printer Interface(Expand): Connect 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 Operation Program


Article One Daily Operation
I. Samples testing

1. Check before Testing


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 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 Permissive testing value of background:

WBC≤0.3×109/L RBC≤0.02×1012/L HGB≤1g/L PLT≤10×109/L

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

Main menu
Review

Welcome to use Tecom


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

QC

Shut down
xxxx-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 result Unit Item Result Unit
WBC 109/L LY% %
RBC 1012/L MID% %
HGB g/L GR% %
HCT L/L LY# 109/L
MCV fL MID# 109/L
MCH pg GR# 109/L
MCHC g/L RDW-CV %
PLT 109/L RDW-SD fL
PDW %
MPV fL
PCT L/L

Diagram No. set 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 Review Method

Press F1 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 tests xxx
No. range xxx-xxx
Input ID
ID xxx

2 Daily total number Show the total number of the date


3 No. Range: Original number and terminative 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 Item Result Unit
WBC 9.3 109/L LY% 17.7 %
RBC 4.14 1012/L MONO% 3.3 %
HGB 121 g/L GR% 78.9 %
HCT 0.361 L/L LY# 1.6 109/L
MCV 87.1 fL MONO# 0.3 109/L
MCH 29.3 pg GR# 7.3 109/L
MCHC 336 g/L RDW 12.8 %
PLT 204 109/L PDW 14.7 %
MPV 12.8 fL
PCT 0.262 L/L

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 WBC
Item Result Unit
WBC 0.0 109/L
RBC 0.00 1012/L [fl]
HGB 0 g/L 0 50 100 300 400
HCT 0.000 L/L RBC
MCV 0.0 fL
MCH 0.0 pg
MCHC 0 g/L [fl]
PLT 0 109/L 0 50 100 200
PLT

****-**-** ** **
[fl]
0 2 5 10 20 30
Next Page

1. 3 5-3
Chapter Six QC of Instrument

Chapter Six Quality Control of Instrument

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’s result. So as to understand the condition of instrument, find out

problems; analyze reasons, take measure decrease and cancel the error in the process of test.

There are two following QC methods.

● Target QC

● Floating 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 Target QC

I 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 large or small.

II Figure of Quality Control


Press the F2 key of target QC in the QC interface, the system will enter into the program of target QC, the

screen displays:

Target QC QC Date F1 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 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 new constant value number and press Enter .

3. Press F3 to input new target value of the target substance and move“← →” input target value and SD

value in the cursor’s frame and then press Enter .

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 value in the picture of target QC is a vertical coordinate after the system is determined,

determined times are horizontal coordinates which draw the point of the quality control and the picture of the

quality control.

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 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 Floating 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 specimens, whether the result can be reported exactly and in time.

II Picture of Method of the Floating average value

Press 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’ specimens), 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, 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 ±2SD) and maximum allowable

boundary (target value ±3SD) 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, 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 Instrument Maintenance


Article One Instrument Maintenance

Press F3 in main menu to enter maintenance program, the screen displays:

Maintenance
Soak and rinse

Thank you for use


T E K -II Mini Aperture rinse
Automatic 3-diff
Hematology Analyzer System diagnosis

Prime reagent

Setup

I Soak and rinse


Press soak and rinse key F1 in main menu to enter the program, the screen displays:

Soak and Rinse

Soaking and Rinsing

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 aperture rinse 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

Aperture is rinsing…

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 Ev4 Ev5 Ev6 Ev7 Ev8 Ev9 Ev10
C C C C C C C C C C

Motor
M1 M2 M3 M4 M5 M6 M7
L/R U/D U/D U/D U/D O/C U/D

Pump C HGB Volt F5 900

Technician No. 0791-8111991

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 operating target.

2 The 1-10 electro-magnetic valve will carry out the change between On and Off by Pressing “Enter” 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 the original position after carrying out diagnosis.

7-3
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 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 Prime reagents
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 Prime Dil
Automatic 3-diff
Hematology Analyzer
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

Priming

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

7-5
Chapter Seven Instrument Maintenance

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

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

Prime All

Priming

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

finishing the operation.

7-6
Chapter Seven Instrument Maintenance

Article Two Daily Maintenance

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 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 Parameter 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 in better state.

2) Spare interval time: Users can set it 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 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.

7-7
Chapter Seven Instrument Maintenance

Warning

Hazardous and Biohazardous Material


● When disposing of waste,do not touch them directly,protective garments and 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 Maintenance

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.

VI. Monthly 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.

7-8
Chapter Seven Instrument Maintenance

Warning

Direction for electric source wire, connection 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


z 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.
z 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

7-9
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 for serious 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.

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 and artificial goods.

● Calibration substance of commodity

3. Preparation of Calibration Substance

1 Check whether it is over the deadline or not 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.

7-11
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 Range
Automatic 3-diff
Hematology Analyzer Preference

Time Setup

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

displays:

Calibration
●Auto Calibration ●Manual Calibration
Item Target Result Coefficient
WBC
RBC
PLT
HGB
MCV
MPV

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

7-12
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=original calibrated factor×

tested value of calibrated substance of the instrument

7-13
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% 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
PLT 100 300 RDW-SD 37 55
PDW 15.5 18.2
MPV 07.0 12.0
PCT 0.100 0.282

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 —10.0 109/L

LY 1.0—3.3 109/L

Mid# 0.2—0.7 109/L

GR# 1.8—6.4 109/L

LY% 20.0—45.0

Mid% 2.0—9.0

GR% 45.0—75.0

RBC 3.50—5.50 1012/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 100-300 109/L

PCT 0.100—0.282 L/L

MPV 7.0-12.0 fL

PDW 15.5-18.2 %

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 has been set, “H” will show in the

printing result, if the value is lower, “L” will show in the printing result.

7-15
Chapter Seven Instrument Maintenance

III 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

Instrument SN xxxxxxxx

Ver. xx.xx.xx

Auto Print F1 Off

Report + Histogram F2 On

Explanation
1.Continuous tests Use digital keys to input number in the menu of working parameter, 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. 1 h). The instrument will carry out a blank test automatically and exit the test

interface after that .

3.Instrument SN Original serial number.

4. Ver.: The version number of software and hardware.

5.Auto Print: Press F1 to change the mode; Press F1 and the screen displays “On”, and the result will 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.Report + Histogram : Press F2 to change the mode; Press F2 and the screen displays “On”, and the

device will print out the histogram while print the result, if Press F2 again the screen displays “Off”, the

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

Automatic Item Result Unit Range Item Result Unit Range


Hematology
Analyzer report WBC 4.8 109/L 4.0-10 MCV 123.6 fL 80.0-100.0
Lym# 2.0 109/L 1.0-3.3 MCH 35.9 pg 28.0-33.0
No. *** Mid# 0.3 109/L 0.2-0.7 MCHC 290 g/L 320-360
Name Gra# 2.5 109/L 1.8-6.4 RDW-SD 27.2 fL 37.0-55.0
Sex Lym% 42.3 % 20.0-45.0 RDW-CV 13.5 % 11.5-14.5
Age Mid% 6.3 % 2.0-9.0 PLT 106 109/L 100-300
Date ****-**-** Gra% 51.3 % 45.0-75.0 PCT 0.117 L/L 0.100-0.282
Time ** ** RBC 2.94 1012/L 3.5-5.5 MPV 11.1 fL 7.0-12.0
HGB 105 g/L 110-160 PDW 16.6 % 15.5-18.2
HCT 0.364 L/L 0.350-0.500
Automatic Item Result Unit Range Item Result Unit Range W
Hematology B
Analyzer report WBC 4.8 109/L 4.0-10 MCV 123.6 fL 80.0-100.0 C
Lym# 2.0 109/L 1.0-3.3 MCH 35.9 pg 28.0-33.0 100 200 300 400 fL
No. *** Mid# 0.3 109/L 0.2-0.7 MCHC 290 g/L 320-360
R
Name Gra# 2.5 109/L 1.8-6.4 RDW-SD 27.2 fL 37.0-55.0
B
Sex Lym% 42.3 % 20.0-45.0 RDW-CV 13.5 % 11.5-14.5 C
Age Mid% 6.3 % 2.0-9.0 PLT 106 109/L 100-300 100 200 fL
Date ****-**-** Gra% 51.3 % 45.0-75.0 PCT 0.117 L/L 0.100-0.282
P
Time ** ** RBC 2.94 1012/L 3.5-5.5 MPV 11.1 fL 7.0-12.0 L
T

7-18
HGB 105 g/L 110-160 PDW 16.6 % 15.5-18.2
10 20 30 fL
HCT 0.364 L/L 0.350-0.500
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 [yy-mm-dd]
xxxx-xx-xx
Time [hh-mm-ss]
xx xx xx

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

back to the setup interface.

7-19
Chapter Eight Analysis and Elimination of Troubles

Chapter Eight Analysis and Elimination of Troubles

I Background
Trouble Reason Analyzing Ways of Elimination
1. The background of a. Aperture or testing pipeline is a. Carry out the soaking and rinsing program, clean
WBC, RBC and PLT dirty. the testing pipeline and aperture of instrument.
exceed the setup range b. The reagent syringe of lyse leaks b. Carry out lyse prime to eliminate the air bubbles.
when start the gas or has air bubbles. c. Carry out a diluent prime to eliminate the air
instrument. c. The reagent syringe of diluent bubbles.
leaks gas or has air bubbles. d. Insert the pipeline under the liquor surface of
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 h. Move away the source of interference.
poor contact.
h. The instrument is interfered.
2. The test values of a. The lyse pipeline did not inserted a. Insert the pipette of lyse under the surface of
WBC, HGB are high under the liquor surface of lyse. liquor.
at the same time. 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. a. Rinsing and wash the aperture.
RBC and PLT exceed b. The counting pipe of RBC leaks b. Connect well the counting pipe of RBC.
the setup range. gas. c. Carry out a prime diluent to eliminate air bubbles.
c. The injector of reagent leaks gas. d. Replace the unqualified lyse with qualified
d. The diluent is unqualified. diluent.

4. 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. out a prime lyse to eliminate the air bubbles.
d. M4 injector no reverse pump d. Check or replace the M4 injector.
reactive.

8-1
Chapter Eight Analysis and Elimination of Troubles

5. Only the background of a. The earth wire of instrument is in a. Reconnect well the earth wire.
hemoblast exceeds the poor contact. b. Move away the source of interference.
setup range. b. The instrument is interfered. c. Replace the unqualified diluent with qualified one.
c. The diluent is 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.
6. The voltage of HGB 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 electric eye is aging or c. Replace the electric eye.
damaged. d. Replace the TL082 Chip.
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.

blocked. c. Enter the program of diagnosis system, repeatedly carry

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 not.

too higher or not. The normal d. Use QC blood or human being vena blood mirror

liquor surface is about 5mm higher inspection revise it.

than the submerged aperture.

d. Not revised.

8-2
Chapter Eight Analysis and Elimination of Troubles

2. The test value of a. The end of lyse pipette is not a.Insert the pipette of lyse under the liquor surface of lyse.

WBC is high. inserted under the liquor surface of b.Add the 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 out the checking of switch-on and switch-off of

about 5mm higher than the 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 observe whether the test is normal or not.

with ground. h. Increase the environmental temperature to 15 -30

h. The instrument is interfered. i. Connect well again the earth wire of instrument.

j. Move away the source of interference.

3. The test values of a. The aperture of RBC is half a. Carry out the program of aperture and wash aperture.

RBC and PLT are blocked. b. Entering the program of system diagnosis, repeatedly

low. b. The amount of second sample is carry out the checking of going up and down of motor

not enough. M7, observe whether the test can be normal or not.

c. RBC counting pool vent liquor c. Entering the program of system diagnosis, repeatedly

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

electromagnetic valve EV7, observe whether the test can

be normal or not.

4. The test values of 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

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 submerged aperture. going up and down of the motor M5, observe whether the

d. The earth wire of instrument test can be normal or not.

doesn’t contact well. d. Connect well the earth wire again.

e. The instrument is interfered. e. Move away the source of interference.

8-3
Chapter Eight Analysis and Elimination of Troubles

5. The test values of a. Lack of diluent. a. Replenish the diluent.

RBC and HGB are b. The placement of diluent is too b. Heighten the place of diluent and the level of instrument.

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 a. The test voltage of HGB is a. Replace the luminotron of HGB and electric eye.

HGB is zero or abnormal. b. Carry out soaking and rinsing once, clean the counting

unstable. b. The counting pool of WBC is dirty. pool of WBC.

c. The lyse is unqualified. c. Enter the program of diagnosis, repeatedly carry out the

d. The liquor drainage in counting checking of switch-on and switch-off of EV6

pool of WBC is not better. electromagnetic valve. and carry out the checking of going

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 a. The voltage of HGB is checked to a. Replace the luminotron of HGB.

WBC, RBC and be abnormal. b. Carry out soaking and rinsing once, clean the counting

PLT are normal, b. The counting pool of WBC is dirty. pool of 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

unstable. blood cell are abnormal 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 5mm higher than the and down of motor M5, observe whether the test can be

submerged gem aperture. normal or not.

b. The counting time is unstable. b. Check whether the counting syringe works normally or

c. The aperture is dirty. not.

d. The earth wire of instrument falls c. Carry out the program of aperture wash, and wash the

off. aperture.

e. The instrument is interfered. d. Connect well the earth wire again.

e. Move away the source of interference.

8-4
Chapter Eight Analysis and Elimination of Troubles

9. The test value of a. The aperture of RBC is half a. Carry out the program of aperture wash and wash the

PLT is high and blocked. aperture.

unstable. b. The earth wire of instrument does b. Connect well the earth wire of instrument.

not contact well. c. Move away the source of interference.

c. The instrument is interfered. d. Resolder or replace the electrode line.

d. The electrode line of counting

pool is not connected or oxidated

10. The test values of a. The aperture of RBC is blocked. a. Wash the aperture.

RBC and b. The connecting pipe of counting b. Connect well the counting pipeline.

hemoblast are all syringe of RBC falls off. c. Repeatedly carry out the checking of going up and down

zero. c. The active of the second absorbing of motor M2.

sample is abnormal.

11. The test value of a. The aperture of WBC is blocked. a. Wash the aperture

WBC is zero. b. The connecting pipe of counting b. Connect well the counting pipeline.

syringe falls off.

12. Aspirator needle a. The Aspirator needle is blocked. a. Using the rinse liquid instead of specimen, continuously

doesn’t suck the b. The pipe of specimen sucking leaks determine several times.

specimen or the gas. b. Check the leaking part and connect well the related

sucked specimen is c. The aspirator needle doesn’t pipeline. Check whether the upper end of connecting pipe

not enough. completely insert into the of aspirator needle falls off or not.

specimen. c. Do correct operation of specimen suction.

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 Analysis and Elimination of Troubles

1.The liquor in counting a. The electromagnetic valveEV5 a. Entering the program, repeatedly carry out

pool of WBC can not be can not work normally. checking switch-on and switch-off of valve EV5,

drained completely. b. The pump of liquor drainage can observe whether the liquor drainage can be normal

not work normally. 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 a. The electromagnetic valveEV7 can a. Entering the program of diagnosis, repeatedly

pool of RBC can not be not work normally. carry out checking switch-on and switch-off of

drained completely. b. The pump of liquor drainage can valve EV7, observe whether the liquor drainage

not work normally. 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 a. The pump of liquor drainage can a. Entering the program of diagnosis, repeatedly

RBC and waste liquor not work normally. carry out checking switch-on and switch-off of

can not be drained b. The electromagnetic valve EV5 or pump of liquor drainage, observe whether the

completely at the same EV7 can not work normally. liquor drainage can be normal or not.

time. c. Buffer bottle leaks gas. 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 Analysis and Elimination of Troubles

1. The liquor can not enter a. The reagent pipette doesn’t insert a. Insert the reagent pipette under the surface of

into the counting pool. under the surface of reagent reagent liquor.

liquor. b. Supplement the reagent.

b. Lack of reagents. c. Entering the program of diagnosis, repeatedly carry

c. The reagent syringe can not work out checking going up and down of motor M5 and

normally. M7, observe whether the liquor can normally enter

d. Electromagnetic valve EV9 can into or not.

not normally open and close. d. Entering the program of diagnosis, repeatedly carry

e. The liquor pipeline falls off. 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 a. The electromagnetic valve can a. Entering the program of diagnosis, repeatedly carry

the counting pool of not work normally. out checking the switch-on and switch-off of valve

WBC. b. EV5 on the bottom of counting EV4, EV8 and EV9, observe whether the liquor can

pool of WBC can not work normally enter into or not.

normally. 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 a. The electromagnetic valve can a. Entering the program of diagnosis, repeatedly carry

the counting pool of not work normally. out checking the switch-on and switch-off of valve

RBC. b. EV7 on the bottom of counting EV4, EV8 and EV9, observe whether the liquor can

pool of RBC can not work normally enter into or not.

normally. b. Entering the program of diagnosis, repeatedly carry

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 Analysis and Elimination of Troubles

1. M1 or M2 can not move a. The motor can not move to the a. Readjust or lubricate.

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

is big. is damaged.

b. The motor can not work. c. Check whether the photoelectricity or the jiggle

c. Photoelectricity transducer or switch is failure.

jiggle switch troubles.

2. M3 can not move to the a. The motor can not move to the a. Readjust or lubricate.

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

is big. is damaged.

b. The motor can not work. c. Check whether the photoelectricity is failure.

c.Photoelectricity transducer trouble

3. M4 can not move to the a. The motor can not move to the a. Readjust or lubricate.

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

is big. is damaged.

b. The motor can not work. c. Check whether the photoelectricity is failure.

c.Photoelectricity transducer trouble

4. M5 can not move to the a. The motor can not move to the a. Readjust or lubricate.

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

b. The motor can not work. is damaged.

c.Photoelectricity transducer trouble c. Check whether the photoelectricity transducer is

failure.

5. M7 can not move to the a. The motor can not move to the a. Readjust or lubricate.

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

b. The motor can not work. is damaged.

c.Photoelectricity transducer trouble c. Check whether the photoelectricity transducer is

failure.

VI Printing

Trouble Analyse Ways of Elimination

1.Do not print a. The installation of print-paper is a. Reinstall the print-paper.

wrong. b. Install print-paper

b. Not enough paper.

VII Display

8-8
Chapter Eight Analysis and Elimination of Troubles

Trouble Analyse Ways of Elimination

1. Blue screen a. The potentiometer not be tuned a. Tune up the potentiometer to the correct position.

up to the proper position.

Note: The troubles explained in this instructions can be 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 Installation Instruction


I. 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 you want to register this program. Dealer will 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. 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 Instruction


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.
Test 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 Parameter, 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 in this record.

VI QC
Details in Chapter Six.(This application added non-target QC).The device test QC substance in
Test 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)

1. Hardware connection: use direct series line to connect (2 pin to 2 pin,3 pin to 3 pin)
2. Series port setup: 19200,n,8,1
3. Communications

Contact Character ‘U’ Within 150ms PC send back ‘S’ available. Separate data with “#”

Item Type ‘8’(or‘9’) # ‘8’ ÆItem 18 ,‘9’ÆItem 19. Use other number for future expanding
Number ***#
WBC Histogram 125 **#
RBC Histogram 125 **#
PLT Histogram 125 **#
18 or 19 Items data See data format below

Testing data ASCII Code Format reference to form as below.


Transportation
No. Item 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 ****#

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 Undetermined

Transportation
No. Item Instruction
Data Format

21 Undetermined Undetermined Undetermined

22 Undetermined Undetermined Undetermined

23 Undetermined Undetermined Undetermined

24 Undetermined Undetermined Undetermined

25 Undetermined Undetermined Undetermined

z Send three character @@@ when completed


Index

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

B
Background……………………………………………………………………………………8-1
Basic Parameters of Instrument………………………………………………………………2-4

C
Check before Testing…………………………………………………………………………4-1
Connection of pipeline…………………………………………………………………………1-2
Calculation Parameter…………………………………………………………………………3-2
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…………………………………………………………………………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
Printer…………………………………………………………………………………………1-2
Power Regulate…………………………………………………………………………………1-1
Purpose of Target QC…………………………………………………………………………6-2
Picture of Method of the Floating average value………………………………………………6-5
Index

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


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

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 QC……………………………………………………………………………………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 Development Zone, Nanchang

Jiangxi,P.R.China Post code 330096

Shanghai International Holding Corp.GmbH(Europe)


Eiffestrasse 80,20537 HHamburg Germany

In vitro diagnostic medical device

Tel 0791-8110293 Fax 0791-8109407 0791-8111989

E-mail tecom@nc.jx.cn http://www.tecom-cn.com

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