PKL PPC 200 Operation Manual

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PKL PPC 200

Full-Automated Biochemistry Analyzer

Paramedical srl
Table of contents
COPYRIGHT AND DECLARATION.................................................................................................. 1

FOREWORD .......................................................................................................................................... 3

1 INTRODUCTION ............................................................................................................................... 6

1.1 PERFORMANCE & CHARACTERISTIC ................................................................................................ 6


1.2 INSTRUMENT CONFIGURATION ......................................................................................................... 6
1.3 SCOPE OF APPLICATION .................................................................................................................... 6
1.4 TECHNICAL PARAMETERS ................................................................................................................ 6
1.4.1 Parameters ................................................................................................................ 6
1.4.2 Power & Operation Environment ............................................................................. 7
1.5 PRINCIPLE,STRUCTURE & FUNCTION ........................................................................................... 8
1.5.1 Principle ................................................................................................................... 8
1.5.2 Appearance ............................................................................................................... 8
1.5.3 Components function ............................................................................................... 9

2 INSTALLATION ................................................................................................................................. 9

2.1 ACCEPTANCE CHECK ..................................................................................................................... 10


2.2 INSTALLATION ............................................................................................................................... 10
2.2.1Installation Environment ......................................................................................... 10
2.2.2 Installation Space ................................................................................................... 10
2.2.3 Power and grounding ............................................................................................. 11

3 OPERATION ..................................................................................................................................... 12

3.1 PREPARATION BEFORE POWER ON .................................................................................................. 12


3.2 POWER ON ..................................................................................................................................... 12
3.3 SAMPLE TEST................................................................................................................................. 12
3.4 RESULTS AND PRINT ...................................................................................................................... 14
3.5 THE END ........................................................................................................................................ 15

4 OPERATION PROCESS .................................................................................................................. 15

4.2 SAMPLE TEST ................................................................................................................................ 16


4.3 EMERGENCY SAMPLE TEST ............................................................................................................ 19
4.4 RE-TEST SAMPLE INPUT ................................................................................................................. 20
4.5 RESULTS AND PRINT ...................................................................................................................... 21
4.6 ITEM PARAMETERS SETUP ............................................................................................................. 23
4.6.1 Parameters setup..................................................................................................... 23
4.6.2Specific parameters setup ........................................................................................ 26
4.7 SPECIFIC TEST ............................................................................................................................... 28
4.7.1 Calibration and QC ................................................................................................ 28
4.7.2 Reagent................................................................................................................... 34
4.7.3 Washing and blank .............................................................................................. 35
4.7.4 Absorbency ......................................................................................................... 35
4.8 DATA MANAGEMENT...................................................................................................................... 36

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4.8.1 Query...................................................................................................................... 36
4.8.2 Reaction curve........................................................................................................ 38
4.8.3 Data Maintenance................................................................................................... 39

5 QC AND CALIBRATION ................................................................................................................ 40

5.1 THE MEANING AND SELECTION OF QC AND CALIBRATION ............................................................. 40


5.2 CONTROLS AND CONTROL PROGRAM ............................................................................................. 40
5.2.1 Controls types ........................................................................................................ 40
5.2.2 Usage and Storage. ................................................................................................. 40
5.2.3 Target Value, SD Value, Control Limit ................................................................... 40
5.2.4 QC program............................................................................................................ 41
5.3 Q.C METHOD ................................................................................................................................. 41
5.4 THE DISPOSAL OF LOSING CONTROL .............................................................................................. 45
5.5 CALIBRATION AND CALIBRATION PROGRAM .................................................................................. 45
5.5.1 When it needs calibration? ..................................................................................... 45
5.5.2 Calibration program ............................................................................................... 46

6 REAGENT, SAMPLE AND WASTE ............................................................................................... 47

6.1 BIOCHEMISTRY REAGENTS ............................................................................................................ 47


6.2 WASHING SOLUTION...................................................................................................................... 47
6.3 POINTS FOR ATTENTION ................................................................................................................. 47

7 MAINTENANCE .............................................................................................................................. 48

7.1 INSTRUMENT INITIALIZATION ........................................................................................................ 48


7.2 SINGLE REAGENT........................................................................................................................... 48
7.3 INSTRUMENT TEST ......................................................................................................................... 48
7.4 INSTRUMENT ADJUSTMENT ........................................................................................................... 49
7.5 MAINTENANCE .............................................................................................................................. 51
7.5.1Daily maintenance................................................................................................... 51
7.5.2Weekly maintenance ............................................................................................... 51
7.5.3Half-yearly maintenance ......................................................................................... 51
7.5.4Yearly maintenance ................................................................................................. 51
7.5.5Cuvettes washing procedure.................................................................................... 51
7.6 INSTRUMENT PARTS REPLACEMENT .............................................................................................. 52
7.6.1 Lamp replacement .................................................................................................. 52
7.6.2 Syringe replacement ............................................................................................... 53
7.6.3 Aspiration probe replacement................................................................................. 53
7.7 OPERATION WHEN THE INSTRUMENT SHUTDOWN FOR A LONG TIME............................................... 54
7.8 PREVENTIVE MAINTENANCE ......................................................................................................... 54

8 TROUBLESHOOTING .................................................................................................................... 55

8.1 TROUBLESHOOTING GUIDANCE..................................................................................................... 55


8.2 TECHNICAL ASSISTANCE ............................................................................................................... 56
8.3 TROUBLESHOOTING DISPOSAL ...................................................................................................... 56
8.4 REPLACE FUSE .............................................................................................................................. 56

II
9 TRANSPORTATION AND STORAGE .......................................................................................... 58

9.1 TRANSPORTATION .......................................................................................................................... 58


9.2 STORAGE ....................................................................................................................................... 58

APPENDIX A: GENERAL TROUBLESHOOTING ........................................................................ 59

APPENDIX B:MAIN PARTS LIST ................................................................................................. 60

APPENDIX C:LIST OF ITEM AND THE ABBREVIATION ...................................................... 60

III
Copyright and Declaration
Copyright © Paramedical srl

Declaration:

All contents in this manual were strictly complied according to related laws and
regulations in Italy, as well as the specific condition of PKL PPC 200 Full-automated
Biochemistry Analyzer, covering all the updated information before printing.
Paramedical srl is fully responsible for the revision and explanation of the manual,
and reserves the right to renovate the relevant contents without separate notification.
Some of the demonstration pictures are for reference and subject to real object if any
differences.

All the information included is protected by copyright. No part of this document may
be reproduced, stored or transmitted in any form, or by any means unless written
authorization by Paramedical srl.

All instructions must be followed strictly in operation. In no event should Paramedical


srl be responsible for failures, errors and other liabilities resulting from user's
noncompliance with the procedures and precautions outlined herein.

Limited Responsibility for Quality Warranty:


The manual for PKL PPC 200 Full-automated Biochemistry Analyzer, defines the
rights and obligations between the Paramedical srl and the customers about the
responsibility for quality warranty and after-sale service, also the related agreements
on commencement and termination.

Paramedical srl warrants the PKL PPC 200 sold by the Paramedical srl and its
authorized agents to be free from defects in workmanship and materials during normal
use by the original purchaser. This warranty shall continue for a period of one year
since the date of installation. The instrument life is ten years.
Paramedical srl assumes no liability in the following situations even during the period
of warranty.

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1. Failure due to abuse the instrument or neglect the maintenance.
2. Use reagents and accessories other than manufactured or recommended by
Paramedical srl.
3. Failure due to operate not under the instructions described in the manual.
4. Replace accessories not specified by Paramedical srl, or after maintenance or repair
by a service agent not approved or authorized by Paramedical srl.

CAUTION:
THE INSTRUMENT IS FOR PROFESSIONAL AND PRESCRIPTION USE
ONLY.

Technical service and troubleshooting are provided by the Service Department of


Paramedical srl.
Professional technician and sale representative will be sent to offer you timely service
when necessary.

PARAMEDICAL SRL

Via Irno snc (ex Tabacchificio Mattiello-Lotto B/2)


84098 Pontecagnano Faiano (SA)- ITALY

Version No.:08/2009

2
FOREWORD
This is an operation manual for PKL PPC 200 Full-Automated Biochemistry
Analyzer.
The principle, operation, maintenance and troubleshooting are contained in this
operation manual, with which users can operate and maintain the instrument.

Symbol legend
Caution, risk of Caution, risk of
danger (See note) electric shock

Caution, hot surface Biohazard

Protective ground
On (supply)
terminal

Off (supply) In vitro diagnostic

Prevent from heat


and radioactive Serial number
sources

Manufacture Recovery

Environment-friendly
use period

Notice:

Please read all of the following warning. Any wrong operation will damage the
instrument or injure the user.
Caution:
The instrument protection may be failure if user doesn’t operate the machine
according to the operation manual.

3
Electricity
In order to avoid electricity dangerous, please observe this warning.
Caution:
When the machine is power on, non- authorized person cannot open the front
panel.
Please turn the power off if there is liquid leakage, Otherwise, it will lead
to electric shock accident or instrument damage.
Photometer Lamp-house

In order to avoid photometer lamp-house dangerous, please observe this warning.


Caution:
Please do not see the lamp directly when the instrument is working.
Otherwise, it will hurt your eyes.

Biohazard

In order to avoid biohazard, please observe this warning.


Biohazard:
Incorrectly handling samples will incur infectious risk to user. Please do not
touch specimen, mixture and waste liquid directly.
Please wear protective gloves, clothes and glasses when operating and
maintaining the machine.
If skin touches sample incautiously, please deal it according to the work
principle or ask for doctor’s help.
Some reagents are strong acid or alkali. Please use them carefully and avoid
direct contact. If the reagent sticks to hands or clothes, immediately wash it
of with water and soap. If the reagent splashes into eyes accidentally, wash
it off with water and consult an oculist.

Waste

In order to avoid environment pollution and personal injury, please observe this
warning.
Biohazard:
Reagent, Q.C reagent, Calibration reagent, Detergent and Waste has some
substance that will lead to environment pollution. Users must observe the
local law.

4
Instrument usage

Caution:
The instrument is intended for quantitatively measuring the serum, plasma,
urine and cerebrospinal fluid etc., If the instrument is to be used beyond
this scope, consult Paramedical srl first.
Test results are just for reference. Please take clinical symptoms and other
test results into consideration before making any clinical determinations.

Operation environment

Caution:
Please install the instrument according to the operation manual. Otherwise,
it will make wrong results or instrument damage.
Please call the Paramedical srl’s service or distributor when you want to
relocate the instrument.

Instrument operation

Caution:
1) Please do as the operation manual. Otherwise, it will make wrong
results and lead to instrument damage or personal injury.
2) Perform calibration and QC analyses for the first time use.
3) QC analysis is needed before sample analysis, which can ensure the
result reliability.
4) Use RS-232 bidirectional data interface or parallel port connection
cable without electric plug.
5) Do not touch the display and keyboard with wet or chemical-stuck
hands.

5
1 Introduction
PKL PPC 200 Full-Automated Biochemistry Analyzer is a discrete, random
access analyzer.

1.1 Performance & characteristic


a) Method:End, Rate, two end points, two points rate, Blank (reagent blank, sample
blank)
b) 120 reaction cuvette with high quality quartz.
c) The cuvette washing system: five needles and eight steps for auto-washing.
d) Tridimensional anti-collision function protects the aspiration probe.
e) Sample needle is imported from Japan with Teflon coating, the inside and outside
mirror polishing technical, and the inside and outside auto-washing technical,
which can lessen the cross-pollution as soon as possible.
f) The syringe is imported from Germany with original package, which can ensure
the aspiration precision and wearable.

1.2 Instrument configuration


The instrument consists of analyzer host, computer and printer etc., and the printer is
optional.

The analyzer host consists of reagent tray, sample tray, analytical tray, specimen
system, washing system, photometric system, liquid tube system and hardware etc..
The reagent tray and sample tray are the same tray.

1.3 Scope of application


The Biochemistry Analyzer has applications to medical field, including the
measurement of body fluid’s some particular chemical in the medical laboratory.

1.4 Technical parameters


1.4.1 Parameters
 System:Full-Automated,isolated/selective access,STAT function.

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 Speed: 260/h(Only Biochemistry)

 Memory: More than 1200


 Measurement method: End, rate, Two-points end, two-points rate, blank
(sample and reagent),etc.
 Calibration method:Linearity, non-linearity,multi-point linearity, Max:7
calibrations.
 Sample tray:45 positions(including Standard, QC and Emergency).
 Reagent tray:30 refrigerant positions
 Reagent:Open reagent
 Sample Volume:2uL-100uL
 Reagent Volume:R1 :2uL-400uL; R2:2uL -200uL
 Min reaction Volume:180uL
 Photometric system:The spectroscopic system after colorimetric tube, 8
kinds of wavelength (340nm, 405nm, 450nm, 510nm, 546nm, 578nm,
630nm, 700nm)
 Cuvette:120 cuvette with high quality quartz.
 Range of absorbency:-1Abs-4.5Abs,resolution ratio: 0.0005Abs
 Lamp-house:Halogen lamp,12V/20W
 Data storage:According to the computer’s hard disk volume.
 Water Consume Volume: 2L/h distilled water
 Temperature:37℃±0.1℃
 Cuvette washing System:Five needles and eight steps for auto-washing

1 . 4 . 2 P ow e r & O p e r a t i o n E n v i r o n m e n t
 Operation Environment:
- Temperature:10 oC~30 oC
- Humidity:≤85%
 Power:AC 110V~240V,50/60Hz
 Atmospheric Pressure:86kPa~106kPa
 Power:200VA

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 Dimension:100cm×66cm×70cm(Length × Width × High)
 Weight: About 100Kg
 The outside insulated resistance with single fault:≤0.1Ω

1.5 Principle,Structure & Function


1.5.1 Principle
The basic principle for the instrument is Lambert-Beer law.
A parallel unicolor wave passes an object with absorbing substance . The object’s
thickness is L, and the concentration is C. Some photons are absorbed when the wave
past the object. The light intensity decreases down from I 0 to I, we can get the
formula:

I 0 = the incident wave intensity


I= the transmitted wave intensity
K= a proportional factor (absorbency coefficient)
User can get the concentration “C” from the formula.
After data transit like the figure 1.5-1, user can get the results.

1 . 5 . 2 Ap p e a r a n c e

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PKL PPC 200
1 . 5 . 3 C o m p o n e n ts f u n c t i o n
a) Sample Tray:Accommodates positions for sample, standard and control
b) Reagent Tray:Accommodates positions for reagents
c) Syringe system:Aspirates sample or reagent to the reaction cuvette. Sample
aspiration probe is also the level sensor.
d) Reaction Tray:Accommodates reaction cuvette. Samples and reagents are
incubated with temperature maintained at 37 degree.
e) Washing System:Purge the reaction solution, clean the reaction cuvette, add and
aspirate the water used by blank. Five needles and eight steps for auto-washing
which can clean the cuvette drastically.
f) Washing system of sample aspiration probe:Clean the sample aspiration probe.

2 Installation
Caution:
The instrument can only be installed by Paramedical srl technical engineer
or person authorized by Paramedical srl.

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2.1 Acceptance check
Please open the package as below procedures after you have received the instrument:
a) Open package carefully and take out PKL PPC 200 and the accessories.
b) Check all of the accessories according as the package list.
c) Contact Paramedical srl if any loss or damage of the instrument exists.

2.2 Installation
It is very important to install the instrument in the appropriate area. The laboratory
must supply stable power and environment to ensure the accuracy and precision of the
analyzer, and also ensure the operation safety. The instrument should keep away from
surroundings at least 0.5 meters, which is convenient for operation and
maintenance.
2 . 2 . 1 I n s ta l l a t i o n E n v i r o n m e n t
 Avoid direct sunshine.

 Avoid dust in the laboratory.

 The installation ground level must be zero gradient.

 The installation ground must be able to bear 400 Kg.

 The room temperature:10 ℃~ 30℃


 Humidity: ≤85%(without condensation).

 Atmospheric Pressure:86KPa~106Kpa.

 Keep temperature and humidity stable to ensure reliable data.

 Keep ventilation and do not face air-condition directly.

 Avoid shaking

 The instrument must be far away from strong electromagnetism.

 The instrument must be closed to the power supply.

2 . 2 . 2 I n s ta l l a t i o n S pa c e
Refer to the figure below for space requirements.

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Instrument acreage: (unit: cm)
Analyzer : 100×66×70(length×width×high)
Operation table(reference only):70×50×80(length×width×high)
2.2.3 Power and grounding
Power must be prepared and the location of switchboard is less than 10m.
 Power
AC110V~240V,50/60Hz。
 Grounding
Use the three-pin plug with ground terminal.
 Plug
One switchboard with 15 ampere, over 3 switchboards with 5 ampere.
High-power machine cannot be used in the same switchboard. For example:
Air-condition, Icebox, etc.
 Power cable
Please use three-core power cable, and the type of cable and plug lies on the
power voltage.

Caution

Please confirm the power grounding. Any improper grounding connection will
influence the test result and damage the instrument.

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3 Operation
Biohazard:
Please wear gloves, working clothes and glasses to protect you when the
instrument is working.
Please read the operation manual carefully before operation

3.1 Preparation before power on


 Prepare one bottle of de-ion water (≥10L).
 Add all kinds of reagent into the corresponding reagent bottles.
 Prepare the test sample and place the reaction cuvettes on the sample tray.
 Check power supply.

3.2 Power on
Turn on the instrument and computer to enter the windows operation interface. Users
can double click icon of “PKL PPC 200” on the desktop to view the “Login” interface.
The main test interface will appear after the user name and password are confirmed.
It needs to incubate about 30 minutes before test.

3.3 Sample test


The soft interface of PKL PPC 200 displays as below:

Click “Routine Operation” to enter the menu displayed as below:

Click “Order” to enter the menu displayed as below

12
User can edit patient information and test item in this interface.
a) Click “Add” to login.
b) Input patient information and sample information(See the underside
chapter).
c) Click and Select test item in the “Item list” , Click “→” to add the selected
item into the “Test item” column, and other items can be added in the same
way.
Press “OK” to confirm it.
User also can press “Profile order” to select test item.
Click “←”to delete the selected item.
d) Repeat the above steps to finish edit and exit.
e) Click “Start” to enter the test interface displayed as below:

13
Check the reagent and sample according to the display order in the test menu, and
then input the reaction cuvette number. Click “start” to confirm related
information and click “YES” to start test.
f) The instrument begins to test and show the sample adding condition.

3.4 Results and Print


Click “report” to view the interface displayed as below:

14
a) Select sample No. to read the test result in the “results” frame. Input the
patient information to view the detailed patient information.
b) It also can add the user-defined calculation item, auto-input item and manual
input item.
c) Print the comprehensive test report or only the patient test report after
confirming test results

3.5 The end


After daily operation, user should exit the test interface and turn off the power.

4 Operation Process
4.1 Flow chart

15
Power on

Incubate 30 mins

No
Calibration?

Calibration

No
Q.C ?

Yes

Q.C

Blank? No

Yes
Keep blank

Input sample information

Test

Test end

Results

Print

Power off

4.2 Sample Test


 Sample preparation: add enough centrifugal serum into the sample cup.
The serum shall be without fibrinogen or hemolysis, etc.. Make sure
that there is no bubble in the sample cups.
 Reagent preparation: add enough reagent into the reagent container.
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The reagent must be within the expiry date, with stable and reliable
quality.
 Washing preparation: it is better to use the de-ion water with
conductance less than 2.0us/cm.
 Click “Routine Operation” to enter the interface as below.

 Click “Order” to enter the interface as below.

 Click “add” to input the sample No..(The sample No. should not be
repeated in the same day.)
 Input patients’ name, sex, and age. Patient information can also be
input when printing test report.
 Input sample cup No., and the cup number is the sample’s position in
the sample tray.(The sample cup No. can be repeated)
 Sample type: blood, urine or others
 Doctor: the doctor who sends the sample

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 Bed No.:the bed No. of the inpatient.
 Department: the department who sends the sample.
 Diagnoses: The patients’ symptom.
 Patient ID: Input outpatient number or inpatient number.
 Profile (batch input): input batch samples by clicking “profile”.
 Item selection: select test item from the “item list” column, or select
from “profile order” column and then press “OK” to confirm.
 Repeat the above steps to input all sample information.
 User can edit the input information. User can select one sample No.
and then modify or delete the input information. Press “OK” to confirm
it.
Note: the patient information can be input here, also can be input when
printing.
 Exit after finishing the input.

 Click “Testing” to enter the menu as below:

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 Check the reagent and sample order according to the display order. Input
the initial reaction cuvettes No. and press “Start”. Then system will show
the interface as below:

This interface reminds the operator to check the initial reaction


cuvettes No. and whether the cuvettes are clean or not?
 Test starts, and the sample adding condition will be shown.
 If user want to pause the operation, press “pause” button.(Note: The
pause time should not be long during test ). Then press “continue” to
start test again. Press “stop” button to cancel the whole operation
and exit.
 In order to observe the working state, the sample adding status will
be shown in the work interface.
 The testing result and absorbency information will be shown in the
results column, and a new result will be shown at 18 seconds. User
can also view the whole results by pressing the scroll bar.

4.3 Emergency sample test


 Emergency sample insert is available at any time during the regular
test process.
 Place sample on the sample tray. (It should be finished as soon as
possible. Any blank position is feasible.)
 Enter the “sample order” menu.

19
 The emergency interface is the same as the general test interface. The
difference is that user should select the “Stat” item on the left-down
corner of the above picture. Then it will test the emergency sample after
finishing the current sample test.

4.4 Re-test sample input


User can re-test the sample if test result is doubtful. The re-test result will replace
the previous. Press the “repeat test” to enter the interface as below:

20
The detailed operation steps as below:
Selects the re-test sample No. from the “order list” and edit it. Please confirm
“√” in the “repeat test” column after selects the re-test item.
User can input the next sample information by repeating the above steps, exit
after complete the input.

4.5 Results and print


Click “report” to enter the interface displays the following:

21
a) The intraday results can be shown in “results” frame.
The test results are shown in results frame after selected the sample No..
Input patient information if needed.
If other test results needed to be printed in the report, user may input the added
items’ name or input the data in the result frame.
Input new results in the modified results frame and then confirm it.(select the
date to print the report in the day.)
b) Click “calculate” to print partially when there is still testing. It is means that user
can get the calculation results once the sample test is over.
c) If user selects “print order” to print the data, then system will print results
according to the sequence setup by the user in the data maintenance.
d) Select print mode in the print frame after the results are confirmed. User also can
select “range” to print.
e) The printed report format displays the following:

××××××Hospital Biochemistry Report


Sample No. Name: Sex: Age: Department::
Sample Type: Patient ID: Bed No.: Doctor: Diagnose:
22
No Item Result Unit Flag Range No Item Result Unit Flag Range

1 ALT 13.00 U/L 0.00—45.00 9 TG 1.46 mmol/l 0.48—1.88


4.6 Item Parameters Setup
User must set the item parameters firstly when the laboratory has new project or
introduce the new reagent into testing.

4.6.1 Parameters setup


Note: there is a password for parameters setup.
The following steps is how to set the parameters:
Click “Parameter” → “item parameters” to enter the interface as blew:

23
a) Click one item name in the “items list”, such as: if you click “ALT”, its ground
color changes into blue.
b) And it will display the item No., item name, full name and parameters, etc.
c) Sampling parameters: sample volume, R1 and R2, which will control the
aspiration volume. The sample volume range is 1-100ul, and R1 is 1-350ul, R2 is
0-200ul. If no R2, input 0 or no data.
d) Test parameters:
The first wavelength: select from 340、405、450、510、546、578、630、700.The
second wavelength: select from 0、340、405、450、510、546、578、630、700.
If without double wavelength, select 0 as the second wavelength.
Test methods: End point , Rate, fixed time, Kinetics, turbidimetry method, etc.
User can choose one method according to the test reagent and test method.

The reaction curve displays the following:

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OD OD
2. 2.0

1.0 1.0

0.0 0.0
0 10 20 30 40 50 0 10 20 30 40 50

End point method Kinetic method


The reading point: the pri-points (main reading section) means the beginning reading
time and the reading period during test.
The whole reading points are 35. The interval of each point is 22 second. The whole
reading time is 770 second (35×22=770) (about 13 minutes).
Such as: the beginning reading point is 3 minutes, the reading interval is 3 minutes.
So the beginning point is 8, and the end point is 17.
If adapt sample blank method, user can choose two-section reading. The “sub-points”
reads sample blank data, and the “pri-points” reads the reaction data. The instrument
will disposal it according to the needs. The first is sub-points and the next is pri-points
when you input the reading section. User can set the data according to the needs.
If the “sub-points” reading section is from 8 to 16, the “pri-points” is from 17 to 35,
the sketch map displays the following:

 Normal range (Range of normal value): it means the test result range of
normal person. The instrument will hint with an over test result.

25
 Corrected (Linearity related): if the test result is different from the
expectation value, user can revise the result by the formula (Y=AX+B),
only change the coefficient A and B.
 Unit: concentration unit, which can be chosen from the pull-down list.
 Decimal (precision): select the decimal number of the test result in the
sub-list.
 The min OD(A): it means the min absorbency. When the negative
reaction item’s absorbency drop down the set value, the system will hint
that the test concentration is high, and the dilution is over.
 The max OD(A): it means the max absorbency. When the positive
reaction item’s absorbency is wrong, the system will hint that the reagent
may be expired.
 Select item in the item list, and click “edit” to modify the parameters.
Click “Cancel” to cancel the modification. Click “Save” to save the
modification.
 Click “Delete” to delete the test parameter.
 Click “Add” to add new item, and save after inputting the test
parameter.

4 . 6 . 2 S p e c i f i c pa r a m e t e r s s e t u p
Click “parameter” → “specific parameters” to enter the interface as below:

26
4.6.2.1 Combination Item parameters setup
a) Refers the above figure, user can click “Add” to input the item number, item
name, and full name, and please keep the item name is completed.

b) Click to add the selected item from the “item list” column into the

“item” column. On the other side, user can click to delete the selected

item from the “Item” column.


c) Press “OK” to confirm the combination setup.
d) Click “delete” and “edit” to edit the input combination item.

4.6.2.2 Calculation Item parameters Setup


a) Click “Add” in the “calculated item” column to input “number, item number,
full number, low, high, and decimal”, and keep the item name is completed. If
the sample test contains all items of the formula, the system will auto-calculate
and print result after tested.
b) Edit calculation formula: double click to choose the item in the “item”

27
column. Note: The formula only consists of the item name and calculation
symbol.
c) Press “OK” to confirm it.
d) Click “delete” and “edit” to edit calculation items.
Caution:
User must delete the deleted calculation item in the print item order,
or it will make an error.

4.6.2.3 Manual Input Parameters Setup


a) In the “input item” column, click “Add” to input the “number, item number, full
number, low, high, and decimal” column.
b) Press “OK” to confirm it.
c) Click “Delete” and “Edit” to edit the manual input item.
Note: The input item of report column must be maintained here.
Caution:
User must delete the deleted calculation item in the print item order, or it
will make an error.

4.7 Specific test


Specific test includes calibration, QC, reagent status, Washing and blank, absorbance.

4.7.1 Calibration and QC


4.7.1.1 Calibration
Make calibration of the reagent before test. Click “specific test” → “ calibration and
QC” to view the interface as below:

28
 Click “Calibration” in the “mode” column.
 User must set the calibration parameters before calibration. Click the
“calibration parameter” to view the interface as below:

29
Select item from “Item list” column. The calibration parameters will be listed in the
parameter column.(The item must be setup in the item parameters firstly)(please
refers to chapter 4.6)
Calibration mode of PKL PPC 200:
a) One-point
b) Two-point
c) Multi-ponits1
d) Multi- ponits2
e) Factor
Calculation formula of PKL PPC 200:
a) Y=AX
b) Y=AX+B
c) Y=A0X^n+A1X^(n-1)+……..+AnX
d) Y=A0X^n+A1X^(n-1)+……..+AnX+B

30
Abs. Abs.

40.0 40.0

20.0 20.0
0.00 0.00
0.4 0.8 1.2 1.6 1.8 OD 0.4 0.8 1.2 1.6 1.8 OD

Fig 1. One-point Fig 2. Two-point

Abs. Abs.

40.0 40.0

20.0 20.0
0.00 0.00
0.4 0.8 1.2 1.6 1.8 OD 0.4 0.8 1.2 1.6 1.8 OD

Fig 3. Multi-ponits1 Fig 4. Multi- ponits2

Abs.
40.0

20.0
0.00

0.4 0.8 1.2 1.6 1.8 OD

Fig5. Factor

Note:
Use signal standard usually.

The meanings of those options in the “calibration parameter” interface:


 Repeat counts: Times of test and the result is an average value.
 Standard counts: several standards at a time, a same item with 6 standards once.
User can make the multi-points calibration.

31
 Sample type: Serum, urine and others.
 Abs. (Reagent/Sample blank absorbance): the value will be auto-test during
calibration. No input.
 Blank type: there are two types: Reagent Blank and Sample Blank. If user selects
reagent blank, the reagent blank value will be deducted from the whole
absorbance value and then get the final absorbance value. If selects sample blank,
the instrument will test sample blank firstly, absorbency secondly. The
absorbency minus the blank absorbency to get the final absorbency.
 Standard: The standard number for each standard when do multi-calibration test.
 Lot(the standard lot No.): Input the standard number.
 Abs. (Absorbance value): The absorbance value of standard when calibration.
 Factor (calibration factor): It is a coefficient that the system calculates according
to the calibrator concentration, OD value, reagent blank.
 Conc. Volume (Concentration): Input the concentration of standard
 Cup (cup No.):The standard position number on the sample tray when calibrating.
The graph is the calibration curve. The horizontal axis is OD value and the
vertical is concentration value.
 Current data (current calibration data): the current calibration result.
User can click “delete”, “edit”, and “OK” to edit the calibration parameters.
Click “exit” to exit the interface.
After confirm the input, click the “start” to test and click “stop” to stop test.
After test, user can click “calibration parameter” to view and edit the calibration
results.

4.7.1.2 Quality Control


To ensure the accuracy of the results, quality control is needed sometimes. Among the
various QC test, one is common sample test, which can view the test result in the QC
range or not? The second method is to do QC test in the QC interface.
● Click “QC” in the “mode” column.

32
● Click “QC parameter” to set it before do the quality control. The interface
displays the following:
 Click “add” to input the QC No.. Select test items from the “item” column into
the “QC item” column.
 Click one item in the “item” column to input “mean and standard deviation”.
User can repeat the step to complete the QC data of each item.
 Click “edit” and “delete” to edit the input value. Press “save” to confirm the value
after inputting.
 Exit and back to the “calibration and QC” interface.
 Click “add” in the “QC” column to input the “QC order No., QC cup No. and QC
lot”.
 Select item from the “item lists” into the “QC-item”. User can repeat the step to
add many QC sample.
 Click “edit” and “delete” to edit the input value.
 Click “Start” to start QC test after confirm the right input. User can press “stop”

33
to end the test. The test results will be shown in the result column and saved in
the QC database.
● Calibration and QC test at the same time
User can select the mode of “calibration + QC” to make quality control after
calibration, and then complete the calibration and QC data to test.

4.7.2 Reagent
a) There is a reagent tray which can place 30 reagent boxes. User can set the reagent
order in the “Reagent status” and calculate the residual reagent volume, which can
avoid the insufficient reagent during test.
Select “reagent status” in the “specific test” column to view the interface as below:

b) User can input reagent information in this interface:


 NO.: ( position No.) 1-30. The position No. of the reagent box on the reagent tray.
 Item: Select the test item from the pull-down menu.
 R1 or R2: it means that the placed reagent type is reagent 1 or reagent 2.
 If user want to test the residual reagent volume, please press “start” button.

34
System will auto-check the volume in reagent container and calculate how many
samples can be tested.

Note:
Ensure that the reagent position is right, and there is enough reagent.

4.7.3 Wa s h i n g a n d b l a n k
a) Click “Wash and blank”
b) Click “wash solution” to add the wash solution to the corresponding cuvettes.
c) Click “dry” to dry the reaction cuvettes.
d) Click “wash” to clean the used or dirty cuvettes.
e) User can click “stop” to stop the operation.

4.7.4 Ab s o r b e n c y
User can test the absorbency and the instrument stability in this part.
a)Press “stability test”, the following menu will be displayed:

Select the interval reading (max is 1 hour) with 340nm wavelength. Press “start” to
test. The instrument will keep recording during the interval and five minutes is a
record. User can observe the data change to judge the instrument reliability.

35
b) The screen displays the following by pressing “reading Abs”:

Select the wavelength from the pull-down list. After prepare the sample, press “start”
to reading. The cuvettes No. and the corresponding absorbance value will be
displayed in the list. User can select the whole reading data obtained from analysis by
pulling the scroll bar.

4.8 Data management


Data management consists of three functions: Query, Reaction Curve, and Data
Maintenance.
4.8.1 Query
There are two sub-menus: result query and QC query.
a) Result query
Click “query” → “result query”, the screen displays the following:

36
Result query methods: by date, by name, etc.
For example: query by date. Select the initial and end date at the right up corner of the
above menu, and then select the precise date from the pull-down list. The daily test
sample numbers will be shown, user can select one sample No. and press “print” to
print the report. User also can click “query” to enter date and name to query.

b) QC query
Click “QC query”, the screen displays the following:

37
User can select test item from the pull-down list, and input start date and end date.
Then ,user can view “date, QC lot and value” from the left column. If many quality
controls have been done at one day, user must select one data as the QC parameter
(the system defaults the first value usually). And then the system will auto-calculate
their average value, SD, CV.
User can press “print” to print QC graph.

4.8.2 Reaction curve


a) The instrument reads a group of data at 22 seconds for every items, and each
item reads 35 point, from which user can see the results’ rightness.
Press “data management” → “reaction curve”, the screen displays the following:

User can press “delete” to delete the selected date’s data in the date column.
Note:
Be caution to use this item. The deleted data can’t be recovered.
User can select the curve type in “sample, calibration and QC”.
Firstly, user must select date:
b) select the daily sample No. in the “sample No.” column, and then the test items will
be displayed in the “item” column. User can select any item to view its reaction curve.
c) user can repeat the above steps to query the calibration and QC curve.
By clicking the “data” button to view the corresponding absorbency data.

38
4 . 8 . 3 D a ta M a i n t e n a n c e
The function of this module is maintain report print and data.
Press “data management” → “data maintenance”, the screen displays the following:

a) In “data maintenance” column, user can input the hospital in “title” column and
edit “item order”. If you want to print operator’s name, please make “√” at the “print
operator’s name” column.
Note:
User must arrange the whole items (calculation item and manual added item).
The item data can not be printed without the corresponding item.
User must delete the deleted item in the “parameter” column, or it will make
an error.

b) In the “data” column, user can set the “unit, department; diagnose, doctor and
sample type”, etc.

39
5 QC and calibration

5.1 The meaning and selection of QC and calibration


The dependability of test results has two meanings. One is high precision. It means
that the test result has good repeatability, which can lessen and delete the influence
caused by random difference. The other is high accuracy. It means that the test result
is closed to the target value, which can lessen and delete the influence caused by
system difference. The selection of control material and calibrator must be carefully.

5.2 Controls and control program


The controls is tested with the test sample simultaneously. It is require steady
preservation time to control the sample’s test difference.

5.2.1 Controls types


 According to the physics character, the controls have Freeze-dry, Liquid and Mix
serum.
 According to the test value, the controls have fixed value and Non-fixed value.
User can select one control from the above.

5.2.2 Usage and Storage.


 Use controls according to the manual.
 Ensure the quality when the Freeze-dry controls is re-dissolved.
 Ensure the adding volume when the Freeze-dry controls is re-dissolved
 Do not shake when the Freeze-dry controls is re-dissolved
 Ensure the controls in the period of validity.
 Ensure the same test condition of the controls and sample testing.

5 . 2 . 3 Ta r g e t Va l u e , S D Va l u e , C o n t r o l L i m i t
Target Value and SD value can be provided by factory according. And user can get it
according to following method:

40
 Temporary Target value(Average Value)and Temporary Standard difference
(SDValue)
For the controls test with new lot number , it need to be tested 20 times at least.
And then the instrument can calculate the average value and SD value.
 General Target value(Average Value)and General Standard difference(SDValue)
Calculate the Normally Target value(Average Value)and Standard difference
(SD Value)tested in 3 to 5 month or the initial 20 data, and then get the average
value .
 Control Limit
Please ensure the control limit of the controls with new lot No.. the control limit
usually shows by many SD values. Different limits are decided by the different
control rules.

5.2.4 QC program
The control program has two systems. One is “Biochemistry Q.C management”
system and the other is “quality control test” system. The former belongs to the
“parameter” menu. Its main function is the parameter set before QC test, such as:
Target Value, SD, the lot No. and deal with the QC data to get the QC analysis graph.
The latter belongs to the “specific test” menu. User can make the QC test for every
items in this system, and the data will be auto-saved to create QC graph for analyzing
and reading. The QC test also can be added in the general test interface, please refers
to the chapter 4.7.

5.3 Q.C method


A) General QC(Westgard)

41
1-3S Random error
1-2S Warning
2-2S Systematic error
R-4S Random error
4-1S Systematic error
10x Systematic error

Q.C Data

No
1-2S Under the control

Yes

No

No No No No
1-3S 2-2S R-4S 4-1S 10x

Yes Yes Yes Yes Yes

Out of control, and correct it.

Fig 5.3-1 Westgard Multi-regulation Q.C


a)1-2s:When one of the two controls is over ±2Sd, and it will enter the next
benchmark.

3s
2s
1s
Aver.
1-2s breach
-1s
-2s
-3s

Fig 5.3-2,1-2 Q.C

b)1-3s: It is random error when one of the two controls is over ±3SD.

3s
2s
42
1s
Aver.
-1s
1-3s breach

Fig 5.3-3,1-3s Q.C

c)2-2s: it is systematic error when the two test results with one control are all over
+2SD or -2SD.

2-2s breach
3s
2s
1s
Aver.
-1s
-2s
-3s

Fig 5.3-4,2-2 Q.C

d)R-4:It is random error when one of the two controls is over +2SD and the other is
-2SD.

3s R-4s breach
2s
1s
Aver.
-1s
-2s
-3s

Fig 5.3-5,R-4s Q.C

e)4-1s:Two controls as a unit when testing. It is systematic error if twice sequential


test results are over +1SD or -1SD, it also means the 4 results are over +1SD or -1SD.

3s
4-1s breach
2s
1s 43

Aver.
-1s
-2s
Fig 5.3-6,4-1s Q.C

f)10x:One control as a unit when testing. It is systematic error if 10 sequential results


are in the same side of the average value.

3s
2s
1s
Aver.
-1s
-2s 10x breach
-3s

Fig 5.3-7,10x Q.C

B) Random error.

a) Imprecise distribution of sample and reagent


Syringe leaks, tube system with air, dirty probe, and reagent expel position inclines.
b) Imprecise colorimetric
Lamp broken
c) Reagent problem
Reagent is expirer.
d)Q.C sample problem
Sample mistake or different lot number.
e)Washing problem
Washing not enough.
f)Mix problem
Cuvettes is not in position or Mix system troubles.

44
C) Systematic error:
a) Standard problem
Dissolve standard incorrect.
b) Reagent problem
Reagent is expirer or different lot number.
c)Temperature
Temperature is incorrect.

5.4 The disposal of losing control


When loses control, user can look for help as below:
 Please fill the reports and report to the lab person in charge.
 Think about all of operations to find out the reasons.
 If there is no obvious mistake, please check it according to the following steps.
a) Re-test the same controls at once.
b) Re-test the out-control item with a new bottle of controls.
c) Re-test the out-control item with a new lot No. of controls.
d) Maintenance machine, and re-test the out-control item .
e) Re-calibration and re-test the out-control item.
f) Ask for the technician’s help.

5.5 Calibration and calibration program


Calibrator is a standard serum with the known test substance. User calibrate one test
method’s value with it. The calibrator can lessen or eliminate the system difference
caused by instrument and reagents. The best calibrator is serum come from human
blood.
5.5.1 When it needs calibration?
The instrument needs make a calibration at six months.
Or, if the following conditions happens, the calibration must be done.
a) First installation.
b) Replace reagent lot or type.
c) There is a big maintenance or an important parts replacement.

45
d) The QC reflects abnormal excursion or over the ruled limited value.
5.5.2 Calibration program
a) In the “Special test” menu, user can calibrates all of the items, and the system will
auto-save the tested data.
b) select “Parameter” → “item parameter” to input the password and enter the set
interface. Select the calibrated item, inputting the concentration tested by the
calibrator and save it.

Caution

The application and test of calibration please view the chapter 4.7.

Caution

please record the calibration. Do not use fixed value serum as the calibrator.

46
6 Reagent, Sample and Waste

6.1 Biochemistry reagents


 Parameter setup with Biochemistry reagent.
 Use registered reagent.
 Read reagent operation before use reagent.

6.2 Washing Solution.


The washing solution is open washing solution.

6.3 Points for attention


a) Follow required laboratory or clinical procedures during daily operation or
maintenance. Wear gloves, lab clothing and safety glasses to avoid direct contact to
the samples.
b) Consider all the clinical specimens, controls and calibrators etc, that contain human
blood or serum as being potentially infectious, wear standard laboratory clothing,
gloves and safety glasses and follow required laboratory or clinical procedures when
handling these materials. Do not smoke, eat or drink at working area. Do not suck or
blow the tubing.
c) Consider the blood samples and waste have potential source of biological and
chemical hazard, the operator should handle with extreme care during the disposal
process and follow criterion of the local government when cleaning, handling,
discharging.
d) Follow the manual to store reagent, calibrators and controls. The customer have
obligation to take actions and management to prevent the reagent, calibrators and
controls from deterioration, misapplication or eating by mistake. The reagent should
be away from temperature extremes.

47
7 Maintenance

7.1 Instrument Initialization


Click “service and adjust” → “Initialization” to reset the instrument.

7.2 Single reagent


Single reagent test only when this item is selected, and it can improve the test speed.
Caution:
This function only used by professional and engineer.

7.3 Instrument test


User can test the each part by instrument test soft to find out the trouble reason.
Click “service and adjust” → “parts testing”, the screen displays the following:

a) Syringe Test
There are two kinds of syringe. One is for reagent and the other for sample. User can
input the absorbed volume into the closed text box. Then press executing button,
syringe begins to absorb the requested volume. Then press “setting 0”, it will run up
to the initial position. If the syringe can't run or the absorb volume is incorrect, which
means that there is a syringe trouble.

48
b) Mechanical arm Test
User can execute the operations according to the test button “sample arm”.
c) Turn tray Test
There are three trays: sample tray, reagent tray and reaction tray. There is a blank box
closed to the tray name. Input the position number, and press the button, the tray will
turn to the corresponding position. Press “setting 0” to replace the tray.
d) A/D Reading
Click the button under “A/D Reading”, and then each wavelength value will be
shown.

7.4 Instrument Adjustment


The main functions of this part: adjust the position of arm probes, the washing volume
and the initial position of each tray.

Note:
The function only for the professional and engineer.
a) Click “service and adjust” → “Adjust”, the screen displays the following:
b) Input password to login.

49
c) Horizontal adjustment
This function can adjust the horizontal turning steps of sample position, reagent
position and cuvettes position. By pressing “Add” or “Minus” to adjust the
horizontal position of sample arm. Click “OK” to save the modification, and click
“cancel” to abandon the modification.
d) Vertical Adjustment
This function can adjust the depth of the aspiration probe and washing arms. By
pressing “Add” or “Minus” to adjust it. If there is no reagent or sample, the
instrument will report. Click “OK” to save the modification, and click “cancel” to
abandon the modification.
The best position of the aspiration probe is the bottom of the test tube.
e)the optical adjustment is charged by the engineer.
f)Sample tray, reagent tray and reaction tray adjustment
The horizontal position must be in the middle position of aspiration probe.
Note:
The function only for the professional and engineer.

50
7.5 Maintenance
7.5.1Daily maintenance
a) Check washing solution bottle and empty the waste bottle.
b) Check the aspiration probe position and keep the pinhead fluent.
c) Check the washing entrance.

7 . 5 . 2 We e k l y m a i n t e n a n c e
a) clean the aspiration probe.
b) Clean the instrument surface.
c) clean reagent container.

7 . 5 . 3 H a l f - ye a r l y m a i n t e n a n c e
a) Check the lamp, replace a new one if needed.
b) Check water pumps runs normally or not.
c) Check the syringe leaked or not. If necessary, replace a new one.

7 . 5 . 4 Ye a r l y m a i n t e n a n c e
a) Check the power voltage and ground wire connection.
b) Maintain the mechanical arms.
c) Replace the tubes.
d) Adjust the mechanical parts.

7.5.5Cuvettes washing procedure


a) 0.525% hypochlorous Na solutions.
b) Prepare three barrels for soaking the cuvettes. The No.1 is antisepsis solutions;
the NO. 2 or No.3 is distilled water.
c) Put the solutions of the cuvettes into the antisepsis solutions pool to avoid
spreading the virus.
d) Rinse the cuvettes at least three times with water.

51
e) Immerse the cuvettes in the No.1 barrel within 10-30min or a little longer.
f) Then rinse the cuvettes at least three times again.
g) Immerse the cuvettes in the No.2 barrel (distilled water) within 10-30min or
a little longer.
h) Take the immersed cuvettes out from the No.2 barrel and put it in again, user
must repeat this operation over three times.
i) Immerse the cuvettes in the No.3 bottle (distilled water) within 10-30min or
a little longer.
j) Take the immersed cuvettes out from the No.3 barrel and put it in again, user
must repeat this operation over three times. Dry the cuvettes after cleaning.
k) Put the open cuvettes adown and air-dry naturally.
l) Heating is forbidden, which will influence the measurement quality of the
cuvettes.
Note:
If using over 50 times, the cuvettes need to be measured up and then
re-used .

7.6 Instrument Parts Replacement


7.6.1 Lamp replacement
Generally, lamp should be replaced in six months or after 1500 hours working.
a) Open the rear panel.
b) Take out the lamp cover.
c) Take out the old lamp and replace a new one (12V /20W). Keep the fastness
between the connectors.
d) Re-install the lamp cover.
e) Re-cover the rear panel.
Note:
The replacement should be executed after lamp is cool.

52
7 . 6 . 2 S yr i n g e r e p l a c e m e n t
a) Open the right panel.
b) Replace the stopcock of the leaked syringe and fast the screw.
c)Recover the right panel.

7 . 6 . 3 As p i r a t i o n p r o b e r e p l a c e m e n t
please replace it, if the probe was broken.
a)Take out the probe cover.
b)Unscrew the fixed screw.
c)Replace a new probe.
d)Fix the new probe.
e)Adjust the probe position.
f)Re-cover the front panel.

Caution

Please ensure the right position of new aspiration probe.

Biohazard

Please wear gloves. If you touch the solution incautiously, please rinse with
water and then disinfections. Otherwise, please call the doctor.

Caution

Please do not broken the probe when you clean it.

Caution

The lamp will be stable after the system startup about 25 minutes.

Caution

53
Be careful when you take out the cuvettes.

Biohazard
Please wear gloves when you operate the aspiration and the cuvettes. If you
touch the solution incautiously, please rinse with water and then disinfections.
Otherwise, please call the doctor.

Caution
Please operation carefully to avoid hurting by the panels.

7.7 Operation when the instrument shutdown for a long time.


If the instrument is stopped using over two days, please do the following steps:
a) replace the distilled water.
b) click the instrument maintenance to rinse the tube and the cuvettes more than
twice.

7.8 Preventive Maintenance


Regular check can ensure the machine performance. .
a) Daily check and regular check.
b) Periodical replacement and maintenance for a prolonged period of non-use.
c) ensure the spare parts enough.
d) improve the running environment, such as: temperature, humidity, water quality,
dust, gas, animal, insect, etc.

54
8 Troubleshooting
Note:
Please confirm power off before troubleshooting.

Biohazard:
Please wear gloves, work clothes and glasses to operate.

This chapter describes all of troubleshooting. According to the procedure, if the


problem can not be solved, please contact with the Paramedical srl service.

8.1 Troubleshooting Guidance


The Troubleshooting Guidance is designed to assist the operator in identifying and
resolving analyzer problems. Instructions are also given for obtaining technical
assistance immediately from Paramedical srl Customer Support Centre. The first step
in the process is to understand normal analyzer operation and preventive maintenance.
Good experience of the analyzer is essential for identifying and resolving operational
problems. Logical troubleshooting may be divided into three steps:
Logical troubleshooting may be divided into three steps:
a) Problem Identification
b) Problem Isolation
c) Corrective Action
Step 1, the problem identification step, is not only identifying what is wrong but also
noting what is right. The investigation should identify the problem area and eliminate
areas that are working correctly. Once this is done, the troubleshooting process moves
quickly to the next step.
Step 2, Problem Isolation, further classifies the problem. Instrument problems are
generally divided into three categories:
Hardware — component related
Software — computer program related
Measurement — related to sample analysis
Typically, hardware and software problems are corrected by an authorized service
representative. Measurement problems are generally operator correctable. This
category is further subdivided into problems related to Sample Handling,
Maintenance.
Step 3, Corrective Action, involves taking appropriate action to correct the problem. If

55
the operator can correct the problem, with or without technical assistance, normal
operation can quickly resume. This Troubleshooting Guide is designed to enhance the
troubleshooting process by providing information to assist in problem identification,
isolation and corrective action.

8.2 Technical Assistance


Technical Assistance is obtained by calling the Paramedical srl after-sales service.
When assistance is needed, please be prepared to provide the following information
for the Paramedical srl after-sales service:
 Instrument Model Name
 Serial number and version number
 Description of the problem and surroundings, including status and operation
 The lot numbers of the reagents.
 Data and report of the problem

8.3 Troubleshooting Disposal


familiar problems and disposals are listed ad follows. If a problem cannot be resolved
or required for further technical assistance, please call the Paramedical srl after-sales
service.
General Troubleshooting(See the Appendix A)

8.4 Replace Fuse


Please replace fuse according to the fig 8.4.1 and fig 8.4.2 as below.

Plughole

Fuse cover

Fig 8.4.1

56
Caution:
Please disconnect the power before replacement.
Caution:
Please do not broken the fuse cover or the plughole when replacing.

Plughole
Fuse

Fuse cover

Fig8.42

Please take out the fuse cover, and replace a new one with 3.15A(Ф5×21)(Fig 8.4.2)。

57
9 Transportation and Storage

9.1 Transportation
Transportation must be according to the contract. Do not ship machine with nocuous,
deleterious and corrosive substance.
Transportation temperature: -40°C~55°C
Relative humidity: ≤95%

9.2 Storage
The packaged instrument should be stored in the drafty room.
Temperature: -40°C~55°C
Relative humidity: ≤85%
Atmospheric pressure: 86kPa~106 kPa
Do not store with nocuous and causticity substance.
The use life is 15 years. Please recheck the instrument to assure the accuracy when it
is stored over one year.

58
Appendix A: General Troubleshooting

No. Description Cause Solution


No power after the a) Fuse broken a) Replace fuse(T 3.15A delay fuse)
1
instrument stared b) Plug loosed b) Call the Paramedical srl service
The power lamp is a) LED broken a)Call the Paramedical srl service
2 not light.

The aspiration a) Tube loose or a)Check tube


probe without jammed b)Replace water pump
3
washing solution b) Water pump
problem
sample volume a) Tube leak a) Check the tube and reconnect it
imprecise b) Syringe’s water right.
4 leak b) Replace the syringe
c) Aspiration probe c) Dredge the aspiration probe
jam
The Aspiration a) Screws a)Call the Paramedical srl service
5 probe position loose. b)Adjust the position
problem
Imprecise result and a) Reagent is a) Check the reagent lot.
bad repeatability expiring b) Check the syringe
b) Syringe leak. c) Replace the lamp
c) Lamp old. d) Re-set the parameters according to
6
d) Incorrect set of the reagent manual
the parameters. e) Connect the ground wire
e) No power f) Call the Paramedical srl service
ground wire.

59
Appendix B:Main parts list
No Item Note
1 Fuse T3.15A L 250V
2 Power switch
3 Boat switch
4 Power filter
5 Motor With connector
6 Pump With connector
7 Power cable
Online control
8
cable
9 Main board
10 Amplifier board
11 Pump tube
12 Elect valve
13 Cuvettes
With lever sensor
14 Sample needle
connector
15 Fan
16 Lamp 12V 20W
Temperature
17 With connector
sensor
18 Peltier With connector

Appendix C:List of item and the abbreviation

60
1) ALT
2) r-GT
3) ALP
4) CHE
5) D-Bil
6) T-Bil
7) ALB
8) TP
9) UREA
10) BUN
11) Cr
12) UA
13) CO2 -CP
14) GLU
15) CHO
16) LDL-C
17) HDL-C
18) TG
19) Cl
20) Ca
21) Fe
22) P
23) Mg
24) AST
25) LDH-L
26) CK
27) CK-MB
28) α-HBDH
29) LD-1
30) PK
31) TBA
32) APOA1/B
33) Ams
34) Hb
35) CO2
36) ACP

61

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