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SUNMATIK-6020 Users manual

Automatic Biochemistry Analyzer


SUNMATIK-6020

Users Manual

SUNOSTIK Medical Technology Co., Ltd.


Address: 733 Kunshan Road, Economy and Technology Development Zone of
Changchun City, Jilin Province, China.
Toll-free hotline: 4008-168-169 800-846-8622
Website: www.sunostik. com

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SUNMATIK-6020 Users manual

1 Preface..................................................................................................................................................... 4
2 System Construction........................................................................................................................... 13
2.1 Analyzing unit............................................................................................................................ 13
2.1.1 Sample/reagent tray..................................................................................................... 14
2.1.2 Dispensing mechanism................................................................................................ 15
2.1.3 Mixing mechanism........................................................................................................ 16
2.1.4 Reaction tray.................................................................................................................. 16
2.1.5 Optics unit.......................................................................................................................17
2.1.6 Washing unit.................................................................................................................. 17
2.2 Operation unit............................................................................................................................18
2.3 Output unit................................................................................................................................. 18
3 System installation............................................................................................................................... 19
3.1 The installation of hardware....................................................................................................19
3.1.1 Unpacking.......................................................................................................................19
3.1.2 Installation requirement................................................................................................19
3.1.3 The connection to accessories and serial port........................................................ 22
3.1.4 Load and take out the sample/reagent tray..............................................................24
3.1.5 Load and take out the sample cup/sample tube......................................................25
3.1.6 Load and take out the reagent bottles.......................................................................26
3.1.7 Replace the cuvettes.................................................................................................... 27
3.2 The installation of software..................................................................................................... 28
3.2.1 The minimum requirement for computer hardware.................................................28
3.2.2 Software installation......................................................................................................28
4 Operating Principle of instrument......................................................................................................32
4.1 Mechanism operating principle.............................................................................................. 32
4.2 Analytical methods................................................................................................................... 32
4.2.1 Type of analytical methods..........................................................................................33
4.2.2 Calibration method........................................................................................................38
4.2.3 Calibration type..............................................................................................................49
4.3 The Checking of test status.................................................................................................... 49
4.3.1 The checking on calibration.........................................................................................50
4.3.2 The checking of absorbance limit...............................................................................51
4.3.3 The linear checking to reaction...................................................................................51
5.The operation of software...................................................................................................................54
5.1 Composition of the form.......................................................................................................... 54
5.2 How to operate the interface elements................................................................................. 55
6 Detailed Operation............................................................................................................................... 57
6.1 Daily operational process........................................................................................................57
6.2 The preparation before analysis............................................................................................ 57
6.2.1 Check before start.........................................................................................................58
6.2.2 Starting up...................................................................................................................... 58
6.2.3 Start the control Software of analyzer....................................................................... 58
6.2.4 Confirm the status of instrument.................................................................................60
6.2.5 Confirm the analytical conditions................................................................................61
6.2.6 The preparation of reagent.......................................................................................... 61
6.2.7 The application of test task..........................................................................................62
6.3 Under testing process..............................................................................................................62
6.3.1 System monitoring........................................................................................................ 62
6.3.2 Suspend adding sample or continue......................................................................... 62
6.3.3 Emergency stop.............................................................................................................62
6.3.4 Add additional sample.................................................................................................. 63
6.4 Confirmation of test results..................................................................................................... 63
6.5 Finish analysis...........................................................................................................................63
6.5.1 Exit the control software...............................................................................................63
6.5.2 Power off.........................................................................................................................63
6.5.3 Operation after power off............................................................................................. 64
7 Sample test........................................................................................................................................... 65

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7.1 Sample register......................................................................................................................... 65


7.2 Patient Information................................................................................................................... 67
7.3 Test Result.................................................................................................................................68
7.3.1 View the results............................................................................................................. 68
7.3.2 Add to the results.......................................................................................................... 68
7.3.3 Modify the result............................................................................................................ 69
7.3.4 Delete the result............................................................................................................ 69
7.3.5 Audit the sample............................................................................................................70
7.3.6 Print the report............................................................................................................... 70
7.3.7 The view of reaction curve...........................................................................................71
7.3.8 Retest the sample......................................................................................................... 72
7.4 Query the Result.......................................................................................................................73
7.4.1 Query by sample........................................................................................................... 73
7.4.2 Query by item.................................................................................................................74
8 Items calibration.................................................................................................................................. 76
8.1 Calibration register................................................................................................................... 76
8.2 Calibration Result..................................................................................................................... 77
8.2.1 The editing of calibration results.................................................................................77
8.2.2 View the calibration curve............................................................................................78
8.2.3 View the reaction curve................................................................................................79
9 Quality control.......................................................................................................................................81
9.1 QC register.................................................................................................................................82
9.2 QC result.................................................................................................................................... 83
9.3 Intraday QC............................................................................................................................... 84
9.4 Interday QC............................................................................................................................... 85
10 Reagent information.......................................................................................................................... 87
10.1 The use of reagent and attentions.......................................................................................87
10.2 The manual registration of reagent..................................................................................... 87
10.3 Reagent volume scan............................................................................................................88
10.4 Barcode scan.......................................................................................................................... 89
11 System setting.................................................................................................................................... 90
11.1 Analysis item........................................................................................................................... 90
11.1.1 Analysis paramter....................................................................................................... 90
11.1.2 Reference range......................................................................................................... 93
11.1.3 The other setup........................................................................................................... 94
11.2 Profile item...............................................................................................................................94
11.3 Calculated item....................................................................................................................... 95
11.4 Manual item............................................................................................................................. 96
11.5 Cross contamination.............................................................................................................. 96
11.6 Print setup................................................................................................................................97
11.6.1 Basic information setup..............................................................................................98
11.6.2 Item order setup.......................................................................................................... 98
11.6.3 Report format setup....................................................................................................98
12 System management...................................................................................................................... 100
12.1 User information................................................................................................................... 100
12.2 Data dictionary......................................................................................................................101
12.3 Data maintemance...............................................................................................................102
12.4 Data statistics........................................................................................................................103
12.5 System log.............................................................................................................................103
13 System maintenance...................................................................................................................... 105
13.1 Serial port setup................................................................................................................... 105
13.2 Action debug......................................................................................................................... 106
13.3 Instrument parameter.......................................................................................................... 107
13.4 Cuvette cleaning...................................................................................................................108
14 System monitoring...........................................................................................................................110
14.1 Sample disk status...............................................................................................................110
14.2 Reagent disk status............................................................................................................. 111

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14.3 Reaction disk status.............................................................................................................112


15 Alarm of instrument and solutions................................................................................................ 113
15.1 Confirmation of alarm information..................................................................................... 113
15.2 Type of alarm information...................................................................................................113
15.3 Content of alarm information and solutions.....................................................................115
16 Instrument Maintenance.................................................................................................................122
16.1 Preparation for the maintenance....................................................................................... 122
16.2 Daily Maintenance............................................................................................................... 123
16.2.1 Checking the Distilled water tank...........................................................................123
16.2.2 Checking the Waste liquid tank..............................................................................123
16.2.3 Checking the Probe..................................................................................................124
16.2.4 Checking the Mixing Probe..................................................................................... 124
16.2.5 Checking the Washing system............................................................................... 125
16.3 Weekly Maintenance........................................................................................................... 125
16.3.1 Cleaning the sample probe..................................................................................... 125
16.3.2 Cleaning the mixing probe...................................................................................... 126
16.3.3 Checking the injecting probe.................................................................................. 126
16.3.4 Cleaning the reagent / sample compartment.......................................................127
16.3.5 Cleaning the waste liquid tank................................................................................128
16.3.6 Cleaning the distilled water tank compartment....................................................128
16.3.7 Cleaning the panel of the analyzer........................................................................ 128
16.4 Monthly Maintenance.......................................................................................................... 129
16.4.1 Cleaning the wash well of the Probe.....................................................................129
16.4.2 Cleaning the wash well of the mixing probe........................................................ 129
16.5 Maintenance every six months.......................................................................................... 130
16.6 Irregular Maintenance......................................................................................................... 130
16.6.1 Cleaning the Sample Probe....................................................................................130
16.6.2 Mixing probe replacement.......................................................................................136
16.6.3 Replacing the Lightsource lamp.............................................................................138
Appendix A System specifications..................................................................................................... 143
A.1 Machine performance........................................................................................................... 143
A.2 Sample system.......................................................................................................................143
A.3 Reagent system..................................................................................................................... 143
A.4 Reaction system.....................................................................................................................144
A.5 Optical system........................................................................................................................ 144
A.6 Calibration and Quality control............................................................................................ 144
A.7 Operating system...................................................................................................................145
Appendix B Accessories/Consumbles...............................................................................................146
Appendix C Parameter list of China National Labs standard of analyzing water GB6682-92.147
Appendix D Barcode reader instruction............................................................................................ 148

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SUNMATIK-6020 Users manual

1 Preface

Thanks for purchasing Fully Automatic Biochemistry Analyzer


SUNMATIK-6020,this users manual introduces how to safely and
correctly operate the Fully Automatic Biochemistry Analyzer
SUNMATIK-6020.

Before using the instrument,please read this users manual thoroughly


and understand it for relevant operation instructions,in order to operate it
correctly.

Please keep this manual available for convenient use.

Product Information

Product name: Fully Automatic Biochemistry Analyzer

ModelSUNMATIK-6020

Registration NumberPermission of JiLin Food & Drug Instrument

Administration 2009

Product StandardYZB/J 00332009

Serial Number of the Product LicenseProducing Certificate


No.20051008 of JiLin Food & Drug Instrument Administration

Registered Address: 733 Kunshan Road, Economy & Technology

Development Zone Changchun 130033, China

Address of Manufacturer733 Kunshan Road, Economy & Technology

Development Zone Changchun 130033, China

Issue Date:2009-09,

Version: V1.1.

File Number:SUNO/SOP-6020-01

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SUNMATIK-6020 Users manual

Users

This manual is written for following clinical laboratory professionals:

Staffs who perform the daily operating task of SUNMATIK -6020;


Staffs who perform the system maintenance and troubleshooting of
SUNMATIK -6020;
Staffs who study the operations of SUNMATIK -6020.

Content:

This user manual is for SUNMATIK-6020 Fully Automatic Biochemistry


Analyzer, this user manual will help you to learn the content of
configuration, operation, daily maintenance and trouble shooting ect.
Please follow this user manual to operate.

Sign convention
Sign and terms

There are some signs and terms in this user manual, in order to ensure
users personnel safety and testing function of the analyzer,please pay
attention to the using of signs!!
The safety symbol below will be used together with words.

Symbol Instruction

WARNING
Remind the user to operate according to user
manual,or it may lead to a personal injury.

BIOHAZARD
Remind the user to operate according to user
manual,or it may lead to a biological pollution hazard

CAUTION
Remind the user to operate according to user
manual,or it may lead to the system damage or a
personal injury

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SUNMATIK-6020 Users manual

Lable and silk screen printing instruciton

The meaning of lable and printing on SUNMATIK- 6020 Automatic


Biochemistry Analyzer instruction below:

Symbol Instruction

CE mark

In Vitro Diagnostics

Biological pollution hazard

Electrical Hzards

Manufacture date

Anti-electric shock standard: Class B

Serial Number

Warning : high temperature

Pictures
The pictures used in this user manual are only for illustration purpose,not
for any other purposes.

Safety Symbols

WARNING

If users dont operate the instrument strictly obey Sunostik


companys user manual,it may lead to an instrument damage or
get an unreliable test result.

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SUNMATIK-6020 Users manual

Electric Shock Prevention

In order to prevent the electric shock caused by improper operation,


please strictly comply with the following matters:

WARNING

When the MAIN POWER or Refrigeration power is on, users is


prohibited to open the rear cover or tear down this instrument if
you are not the authorized person by this company,once there is
liquid access to inner system or there is a leakage on
system,please switch off the power immediately,and contact with
Sunostik Customer Service Department or your local
distributor.Improper operation may lead to an electric shock risk
and may cause a system damage.

To prevent personal injury caused by moving parts


In order to prevent from the personal injuries caused by moving parts,
please strictly comply with the following note

WARNING
When the system is working,dont touch the moving parts of
system,the moving parts include:sample probe,mixing probe and
washing parts. when the system is working,Strictly prohibit to put
fingers or hand into the moving parts.

Biochemistry dangerous protection


In order to protect the biochemistry dangerous effectively,please comply
with the following attentions:

Biological pollution hazard


Inappropriately use of sample may lead to pollution. Do not touch the
sample ,mixture and waste with your hands. You must wear gloves and
lab coat on operation, if necessary,wear the goggles.
In case the sample contact with your skin,please deal with it
immediately follows users working standard.
Some reagents are of strong acidic or strong basicity.Please pay more
attentions when using reagents,avoid your hand or cloth directly contact
with reagent.Once your hand or cloth contact with reagent
carelessly,please flush it with soap and water immediately.If you
carelessly make the reagent to your eyes,please fluch your eyes with a

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SUNMATIK-6020 Users manual

large quantity of water immediately,and consult an oculist

Waste liquid treatment:


In order to prevent the environmental pollution and personal injury caused
by waste,please comply with the following instructions: .

Biological pollution hazard

Because some substances in reagent,calibration solution, correction


liquid,strengthening offs,waste are controlled by pollution regulations
and emission standard.Please comply with the rural emission
standard,and consult the manufacturer or distributor of the
reagents.

Cautions
In order to use this instrument correctly and effectively,please
read the following cautions carefully.

System function
Warning
This instrument is mainly used to quantitative analysis the sample for
serum,plasma,urine,cerebrospinal fluid,etc.If your purpose to use this
instrument exceeds this range, please consult Sunostik company.
When you making the clinical judgement according to the analysis results,
please also refer to the other clinical symptom or other test result.

Operating environment

Take care

Please install the instrument in an specified installation environment comply


with this manual.

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SUNMATIK-6020 Users manual

If you and operating the system in other environment may lead to unreliable
results and even equipment damage. To relocate the system, please contact
SUNOSTIK Customer Service Department or your local distributor.

Preventing Interference by Electromagnetic Noise


Take care
Electromagnetic noise may interfere with operations of the system. Do not
install devices generating excessive electromagnetic noise around the
system. Do not use such devices as mobile phones or radio transmitters in
the room housing the system.Do not use other CRT displays around the
system.

System operation

Take care
1Operate the system strictly as instructed by this manual. Inappropriate use of
the system may lead to unreliable test results or even equipment damage or
personal injury.
2Before using the system for the first time, run the QC program to make sure the
analyzer is in proper state.
3Do not open the cover of the sample/reagent disk when the system is in
operation.
4The RS-232 port on the analyzing unit is to be used for connection with the
operation.
unit only. Do not use it for other connections. Only use the supplied cable for
the connection.
5The operation unit is a personal computer with the operating software installed.
Installing other software or hardware on this computer may interfere with the
system operation. Do not run other software when the system is working. Do
not use this computer for other purposes or connection to the Internet.
Otherwise virus may be introduced and spread into the system through floppy
disks, software or network.
6Do not touch the display, mouse or keyboard with wet hands or hands with
chemicals.
7Dont place the MAIN POWER to ON again within 10 seconds since placing it
to OFF; otherwise the system may enter the protection status. If it does so,
place the MAIN POWER to OFF and place it to ON again.

System maintenance
Please make a regular maintain to the system as follows. Inappropriate
maintenance may effect the working life or effect the entirety performance of
instrument.

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SUNMATIK-6020 Users manual

Note
1Maintain the system as Chaptert 7 System maintenance of this
manual. Inappropriate maintenance may lead to unreliable results,
effect the entirety performance and working life,even lead to the
system damage or personal injury.
2If the system is under a long-term lay up,the surface may has dust. To
wipe off dust from the system surface, use a soft, clean and wet (not
too wet) cloth, soaked with soap water if necessary, to clean the
surface. Do not use such organic solvents as ethanol for cleaning.
After cleaning, wipe the surface dry with dry cloth. Switch off all the
powers and disconnect the power plug before cleaning. Take
necessary measures to prevent water ingression into the system,
otherwise it may lead to equipment damage or personal injury.
3 After replacing the major parts as lamp, sample probe, mixing probe
assembly, you must do a QC analysis.

Sample
Take care

(1) Please use the serum sample of completely separated.If the serum sample
contains fibrin,it may block the sample probe,effect the analysis result.
Medicines, anticoagulants or preservative in the samples may lead to
unreliable results .
Hemolysis, jaundice or chylomicron in the samples may lead to unreliable test
results, so sample blanks are recommended.
2Store the samples properly. Improper storage may change the compositions of
the samples and lead to unreliable results.
3Sample volatilization may lead to unreliable results. Do not leave the sample
open for a long period.
4Not all the tests the reagents claim capable of analyzing can be analyzed on the
system. Consult the reagent suppliers for details.
5Certain samples need to be processed before being analyzed by the system.
Consult the reagent suppliers for details.
6The system has a specific requirement on the sample volume. Refer to this
manual for proper sample volume.
7Load the sample to proper tube position on the sample disk before the analysis
begins; otherwise you will not obtain correct results.

Reagent,calibration solution and blank solution

Take care

1Use proper reagents, calibration solution and blank solution when


analysising.
2Select appropriate reagents according to performance characteristics of
the system. Consult the reagent suppliers, Sunostik or Sunostik-authorized
distributor for details, if you are not sure about your reagent choice.

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SUNMATIK-6020 Users manual

3Please comply with the using instructions for the storing and using of
reagent,calibration solution and blank solution.
If you store the reagent,calibration solution and blank solution in an improper
way,even they are in period of validity,it may also lead to not obtain reliable
results or best performance of the system.
4Perform calibration after changing the reagents. Otherwise, you may not
obtain reliable results.
5The cross contamination to reagents may effect the test results. Consult
the reagent suppliers for details.

Parameter setting
Take care
Before testing,you must set the sample volume,reagent
volume,wavelength,when setting these paramters,please comply with the
relevant instructions of this manual,and reference the reagent instruction.

Data backup
Take care
The system automatically stores the data to the built-in hard disk. However,
data loss is still possible due to mis-deletion or physical damage of the hard
disk. Sunostik recommends you to regularly back up the data to such
medium as CDs.

Statement
Sunostik has the right to modify the content of instruction without notice.
Sunostik has the right to improve technology without notice.
Sunostik has the right to change the specification of product without notice.
Sunostik don't guarantee for this material in any form, including the implied
guarantee for the merchantability and fitness.
Only in following situation, Sunostik will be responsible for machine's security,
reliability and function:

The assembly manipulation, extension, re-debugging, improvement and


requirement work are all done by sunostik's staff;
Relative electrical device meet the requirement of national standard
The operation is according to the guidance of instruction
If following situation happened,Sunostik is not responsible for the safety,reliability
and running state of product:

Subassembly is disassembled, stretched, or re-debugged by non-sunostik-staff;

The equipment is repaired, changed, or disassembled by someone without the


authorizing of sunostik;

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SUNMATIK-6020 Users manual

The damage of instrument is caused by not correctly refer to theUser manual.

Repair service

The equipment can enjoy free service if it is in the prescribed scope of company's
warranty service regulations.
Charging service range
1 Company will charge for the service if it is out of the prescribed scope of
company's warranty service regulations.
2 Even though the equipment is in the warranty period, company will charge
in following situation: man-made damage; improper using; irresistible
nature disaster ;the voltage of electric defence is out of regulated scope;
change accessories and consumptive material without permission of
sunostik ; equipment is repaired by non-sunostik-staff.

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2 System Construction

SUNMATIK- 6020 consists of the analyzing unit, operation unit, output unit,
replacing parts and consumables.

2.1 Analyzing unit


The analyzing unit consists of Sample/Reagent tray,Dispensing mechanism,Mixing
mechanism,Reaction tray,Optics System and washing system,used to analysis
operation.

Picture 2.1 instrument general view

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2.1.1 Sample/reagent tray

Picture 2.1.1 Sample/reagent tray

The sample/reagent tray is used to place the reagent and sample,it is composed of
three circles:inner circle,middle circle and outer circle, the inner and middle circle is
used to place single,double reagent,including 44 reagent positions contains
single/double reagent,they can be mixed placing.The outer circle is used to place
samples,it could place 44 samples.

The sample position could place following sample tubes


Micro sample cup and centrifugal tube
Blood collection tube 1268.5129912.77512.7100
Plastic tube
The reagent positions could only hold Sunostik original bottles, reagent bottles
have two type s,the volumes are :40ml and 25ml.
The sample/reagent tray is located in the sample/reagent compartment,this
sample/reagent compartment has a function of continuous refrigerating,the
refrigerating temperature is: 4-15

Take care
Make sure to cover the reagent tray well, otherwise it may reduce the
refrigeration capacity of refrigerating system, and may damage the sample
probe. Before running the analyzing unit, make sure that the cover is closed or
the probe may be damaged.

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SUNMATIK-6020 Users manual

Attention
The refrigerating system is mutual independent with the power of analysis
unit,when the main power of analysis unit is off, the refrigerating system
can still be on working condition.
Please dont use sample tube and reagent bottle out of specification.

2.1.2 Dispensing mechanism

The dispensing mechanism is mainly composed by sample/reagent probe, arm,


and shaft,it is used to aspirate specified volume sample or reagent from sample
tube or reagent bottle,then dispense to reaction cuvette.
After dispensing the sample or reagent, the dispensing mechanism automatically
moves to the washing well position ,to wash the inner and outer wall of sample
probe.
Arm

shaft

Sample Probe


Washing well

Picture 2.1.2 dispensing mechanism


Sample volume3~30l1l increase
Reagent volume150~300l1l increase
The dispensing mechanism has functions of preheating the reagent, detecting
the sample/reagent liquid level, trace with volume and protecting against
collision in the vertical direction.

Warning
When the analyzing unit is in operation, do not place any part of your body or
any obstacle in the route the arm moves. Otherwise, it may lead to personnel
injury or equipment damage.

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SUNMATIK-6020 Users manual

2.1.3 Mixing mechanism

The mixing mechanism is mainly composed by mixing probe,arm and driving


shaft,it is used to mixing the reaction liquid in cuvettes.

Arm

Driving shaft
Mixing probe

Washing well

Picture 2.1.3 mixing mechanism

When testing single reagent item,the mixing mechanism will mix the mixer
immediately after the reaction cuvette was dispensed sample and reagent;when
testing the double reagent item,it will mix after the reaction cuvette was secondly
dispensing the reagent.
When finished mixing movement,the mixing mechanism will automatically move to
the washing well position to wash the outer wall of mixing probe.

2.1.4 Reaction tray

Reaction tray is used to place the reaction cuvette,cuvette is the optical cuvette
used to colorimetric readings.

Picture 2.1.4 Reaction tray

The reaction tray contains 48 cuvettes,can install 6 cuvette segments.On the


analysis process,the appointed cuvette will stop on the dispensing position to

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SUNMATIK-6020 Users manual

dispense sample or mix, The colorimetric readings are taken when the specified
cuvette passes through the optical axis.
The specification of cuvette is: 5mm6mm25mmoptical path is:6mmvolume is
750lreaction volume is 150~300lit could be repeat usedWhen there is an
error caused by the decreased smooth level to cuvette,please replace the single
cuvette or the cuvette segment by hand.
The reaction tray is placed in the temperature-controlled chamber, which keeps a
constant temperature at 370.1.

Caution
Turn off the power of system when changing cuvette, and turn it to the right
position with hands. Then disassemble the old cuvette and find the position in
cup, then push it and put the new one on it. Please avoid scuffing the new
cuvette , and not defiling the transparent surface.

2.1.5 Optics unit

The optics unit is the core component of this testing system,used to measure the
absorbance of the reaction mixture in the cuvette.This Analyzer adopts
Back-Dividing-light technology and provides 10 wavelength for options :340nm
405nm450nm492nm505nm546nm578nm620nm670nm700nm and
1 to be developed.
The light source is Halogen lamp 6V/10W, the life span can reach to 3000 hours or
above.

Caution
When the A/D values for all wavelengths decrease and lead to the test
performance ,you need to consider to change the light source.When replacing the
lamp,you need to trun off the power, the system at least need to cool for 20
minutes before replacing,otherwise, the hot surface of light source can easily lead
to burn.

2.1.6 Washing unit

The washing unit contains the washing of sample/reagent probe and cuvettes.

1The washing of sample/reagent probe


When finish the adding sample of an item,the sample/reagent probe will return
back to washing well position,the washing motor and the valve of clean pipe will

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SUNMATIK-6020 Users manual

open,to execute the washing operation to both inner wall and outer wall.When the
mixture of sample and reagent was added to cuvettes(single reagent)or when
adding to the reagent 2,the mixing probe will begin to mix,and will come back to the
washing well position once finish mixing,to wash the outer wall of mixing probe.
2The washing of cuvettes
The washing of cuvettes are consist of washing probe(includes the injection needle
and sucking needle ), driving shaft, stepping motor and clean pipes. The cleaning
system is an 8 steps automatically washing system: which are washing solution
+distilled water+ distilled water+ distilled water+ distilled water + distilled water
+distilled water + suck dry + suck dry.

2.2 Operation unit


The operation unit is the computer,the inner installed the control software,which is
used to control the running and operating of system and the processing and
printing of data.

2.3 Output unit


The output unit is a printer which connected with computer,which is used to print
the testing data. There are three print formats,the title could be inputed by yourself .

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SUNMATIK-6020 Users manual

3 System installation

3.1 The installation of hardware

Warning
SUNMATIK-6020 can be installed only by the technical staff of
SUNOSTIK company or by SUNOSTIK-authorized person.

3.1.1 Unpacking

Before installing,please carefully check if the package is well. If you see any signs
of mishandling or damage, file a claim immediately with Sunostik Customer Service
Department or your local distributor.

After opening the package, check the delivered goods against the packing list as
well as the appearance of the system. If you find anything missing or damaged,
alert Sunostik Customer Service Department or your local distributor immediately.

3.1.2 Installation requirement

Take care

Please install the SUNMATIK-6020 as following installing conditions,or it may


effect the analyzing performance.

3.1.2.1 Requirement for installing environment


Only used for indoor installation;
The bearing platform (or ground ) should be smooth (the gradient should be
less than1/200
The bearing platform (or ground ) should be able to bear the weight of 100
kg at least
Well ventilated
The environment should be dust-free as far as possible
Avoid direct sunlight
Avoid to install the instrument near the heat source and wind source

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SUNMATIK-6020 Users manual

No corrosive gas and flammable gas


The bearing platform (or ground ) should be of no shocking
No large noise source and power supply interference;
Keep away from brush-type motor and electric contact equipment which
needs a frequently turnning on and off;
Keep away from the equipment which generates electromagnetic,such as
mobile phone or radio transceiver;
The altitude of the working place should be less than 2000 meters.

Warning
When the dip angle in the front and back direction is larger than 8 degree, the
vertical machine will have the danger of dumping and lead to the damage of the
machine. Therefore,necessary protective measure should be taken to prevent
system damage in storage ,handling ,etc..

3.1.2.2 Requirement for power supply


Power supplyalternating current 198V242V50/601Hzthree core
powergood ground connection
The system needs a well ground connection plug seat to provide required
power supply
The distance between plug seat and the system should be less than 3
meters
The current of plug seat should be not less than 10A.

Warning
Connect the power with ground correctly.Improper connecting with ground
may lead to an electric shock or system damage. Please check that the
output voltage of plug seat meets the system requirements and has installed
a proper fuse (6A/220V 520).
3.1.2.3 Requirement for humidity and temperature
The humidity and temperature for storage
The storage temperature of this system is 040fluctuation<2/H
The storage humidity of this system is 30%RH80%RHwith no
condensation.

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SUNMATIK-6020 Users manual

Warning
If the system is not used for a long time,may speed the aging rate for the
machinery and electric circuit of this system, so if don't use the equipment for
a long time,please run the equipment at least for one time every regular
intervals.

The humidity and temperature for working


The working temperature of this system is 1530fluctuation <2/H
The working humidity of this system is 30%RH80%RHwith no
condensation.

Warning
Operate the system within the regular range of environment,humidity and
temperature,or the result will be unreliable. If the temperature or relative
humidity exceed above range, we suggest you to use air-conditioning
equipment.

3.1.2.4 Requirement for water supplying and draining


The water quality must meets GB-6682 three-level requirementsee the
appendix C
The temperature of water supply is 5~50.

Take care
The water quality must meets GB-6682 three-level requirement,if you use the
undesirable distilled water will have a big effect to test result.

3.1.2.5 Requirement for installation space


The installation and using of the system should fulfill the space requirments as
shown below.

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Min:500
RS-232 Connection
RS-232 RS-232

Computer
Analyzer Min:500

frontage

Min:500 Min:500

Unitmm
Picture 3.1.2.5 Installation diagram

3.1.3 The connection to accessories and serial port

Biological pollution hazard


When emptying out the waste liquor, please be sure to wear work clothes
and gloves to prevent the inflection. If need be, please wear safety
goggles.

Take care
When placing the waste liquid bucket, the top of the bucket can not be
higher than waste liquor outlet under the part of analysis to make sure that
the liquid flows out smoothly.
Make sure there are no bending, twisting and insecure connecting in waste liquid
pipe/distilled water pipe/washing solution pipe/ pipe of water refrigeration cycle.
If not, the instrument can not work normally because of the liquors abnormal
circulating and water leaking, even worse will cause the damage of analyzing part
seriously.

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1 Make sure the power of analyzing part has been turned off.
2 Insert one aspect of the distilled water soft tube to the back board which
wrote entrence of distilled watersee below picture, and insert the other
aspect into the bottom of distilled water bucket.
3 Insert the two aspects of the waste soft tubes separately to the back board
which wrote waste liquid exit(pay attention to the diameter of tube )and
insert the other two aspects of the tubes into the top of the waste liquid
bucket.
4 Insert the washing solution soft tube into the bottom of washing solution
bucket in the cabinet(open the front door of instrument) of the instrument.At
the same time,Insert the sensor of washing solution into the washing
solution bucket from the round hole.
5 Aiming the sensors plug to sensor port joint on the back of analyzer,push
forward slightly, and fasten the screws on two sides.
Separately connect the serial port line to the port of computer and the back
6 of instrument which wrote RS-232 port (see below picture). And twist two
sides screw tightly of serial port line.

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SUNMATIK-6020 Users manual

instrument back

Label
COMPUTER RS-232 connector Washing solution

RS-232 Water PUMP Fan


AC230V,F6A

LIQUID SENSOR

POWER
RS-232 Waste*2
SENSOR
PLUG

waste tube*2

W-SENSOR WS-SENSOR DW-SENSOR

WASTE Washing Distilled


solution water
Picture 3.1.3 The connection chart on the back of analyzer

3.1.4 Load and take out the sample/reagent tray

Take care
Before you need to load or take out the reagent/samples tray, please
confirm reagent samples tray has been on stopping situation.Youd
better to operate above movement after turning off the power supply of
analysis part.
Biological pollution hazard
Before you install or take out reagent/samples tray, please wear gloves
and work clothes to prevent inflection, if need, you should wear
protective gloves. Please notice that reagent/samples tray must be
installed or taken out vertically, topple from side is prohibited, because
this way, samples/reagent can flow out.

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Picture 3.1.4 sample/reagent tray chart

When loading the samples/reagent tray, the samples/reagent tray should be on


horizontal situation, aiming the pole of hand wheel on samples/reagent tray
towards the metallic hole on the drive axle, meanwhile aiming the positioning
hole of sample tray towards the locating pin on the principal axis,then
clockwise swirl the knob on the sample/reagent tray,and lock samples/reagent
tray on drive axle tightly.
When taking out the samples/reagent tray,anticlockwise swirl the knob on the
sample/reagent tray, raise the knob upward, then you can take it out.

Caution
Samples/reagent storehouse and samples/reagent tray may be polluted
during using, when samples/reagent splash in samples/reagent house
or on samples/reagent tray, please shut down power of analytical part.
And wipe clearly by he rag with water or disinfectant. Please do it
regularly. Before running system, please check whether the installing of
samples/reagent tray is sturdy, the cover of reagent bottle is gotten rid
of and the reagent bottle reaches the bottom of reagent house. Or the
samples adding needle will be damaged.

3.1.5 Load and take out the sample cup/sample tube

Biological pollution hazard

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When you load or take out samples test tube/samples cup, please
wear gloves and work clothes to prevent inflection, if need, you should
wear protective glasses.

Attention
Before loading or taking out the sample tubes, please make sure the
samples/reagent tray and sample probe are under stopping
situation.Dont use the sample tubes/sample cups out of designated
specification.

When loading the samples tube, please insert the samples tube into samples test
tube clip, till the bottom of sample tube touches test tube seats circle notch.
When taking out the sample tube, hold the sample tube upward by hand, you can
take it out.

3.1.6 Load and take out the reagent bottles

Biological pollution hazard

When you load or take out the reagent bottles, please wear gloves and
work clothes to prevent inflection, if need, you should wear protective
glasses.

Attention

Before loading or taking out the reagent bottles, please make sure the
samples/reagent tray and sample probe are under stopping situation.Dont
use the reagent bottles out of designated specification.

When loading the reagent bottles, please insert the reagent bottle contains reagent
into the reagent bottle slot,till the bottom of reagent bottle touches reagent bottle
slot.
When taking out the reagent bottle, hold the reagent bottle upward by hand, you
can take it out.

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3.1.7 Replace the cuvettes

Biological pollution hazard:


On operation, please wear gloves and work clothes to prevent inflection, if
need, you should wear protective glasses.

Attention
When replacing the cuvettes/cuvette segment,please make sure the system is
under power off/stopping situation.

When replacing the cuvettes, please firstly make sure the system is under power
off/stopping situation, then turn the reaction tray to the position of needed replacing
segment with hand/or with commond,swirl the screws used to fix this segment,you
can take the whole segment out from reaction tray,you could find the needed
replacing cuvette,press the bottom of cuvette and push it upward vertically, you
could take out it,then to replace a new cuvette.When replacing the new cuvettes,
dont make the side of light pass through dirty.

knob screw

colorimetric cup groups

Picture 3.1.7 Reaction tray

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3.2 The installation of software

3.2.1 The minimum requirement for computer hardware

ProcessorIntel PentiumIV 1.6Ghz above


storage unit DDR2 512M above
fixeddisk80G above
CD-ROM:52Xabove
The minimum requirement monitor15 inches above
for computer hardware Keyboardstandard 101 keyboard
Mousestandard
input-output interfaceat least one RS-232 interface
Operating systemWindows XP
Printer:Connect to fixed printer

3.2.2 Software installation

Put the software to CD ROM of computer, click the sign of CD ROM.Find the file
SUNMATIK-6020 from CD,double click it,the following installation icon will be
shown.

Double click the above icon with left key of mouse,The control software for
SUNMATIK-6020 will be automatically installed.As shown below:

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SUNMATIK-6020 Users manual

ClickNext,the following interface will appear:

Click Next,the following interface will appear:

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SUNMATIK-6020 Users manual

On above interface,the default install path is C: \, choose the default path or other
path, then click Next to install the software on the hard disk.

After the process bar finish, will show the following display interface:

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SUNMATIK-6020 Users manual

Clisk Finish on the above display interface, it means that the software installation
is finished. There will be a shortcut icon for the control software on the desktop.
As shown below:

Double-click the icon will enter the control interface of the software.

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4 Operating Principle of instrument

4.1 Mechanism operating principle

After starting the analytical system, the analyzer will reset first, the reagent tray and
the reaction tray will turn to No.1 position, sample probe and mixing probe will stop
above each washing well, and washing needles stay at the toppest position.
The washing system starts the washing from the No.1 cuvette, then after rotating 2
circles, it stops and starts to wash the No.2 cuvette, then repeat the same
procedure, until it washes the No.17 cuvette.It takes about 12 seconds for the
reaction tray to rotate two times. During the washing procedure, the cuvettes pass
through the photometry part, so at the same time, the blank value of the cuvettes is
also gotten. This blank value can be used as the reference value for the future
tests.
When the washing system starts to wash the No.18 cuvette, the sample probe will
start adding sample and reagent R1 to the No.1 cuvette, when the sample probe
leave No.1 cuvette, the mixing probe starts to mix the reaction liquid in No.1 cuvette,
when the sample probe, mixing probe and washing system all leave the reaction
tray, the reaction tray starts rotating, after rotating for 3 circles, it will stop and
repeat the above procedure. In each rotating,the instrument will collect the data to
the reaction liquid for one time, and treated it as a photometry point. When rotating
to the 11 photometry point, add the reagent R2, repeat the above procedure and till
the reaction is finished.

4.2 Analytical methods


Biochemistry Analyzer is based on the substances selective absorption
for light, which is the analytical methods original from Lambert-Beer Law.

Its detection principle is:the monochromatic of specific wavelength gets through the
cuvettes which contain the sample solution, absorbed intensity of the
monochromatic(absorbance) is proportion to the sample solution concentration &
the distance of light through the sample solution (light path)

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1 I
That is A lg lg 0 b c
T It

Thereinto
A the absorbance when the light through the absorbed solution;
T light intensity of transmission light contrast to incident light, that is
light transmittance It /I0;
I0 light intensity of incident light;
It light intensity of transmission light;
solution molar absorptivitymlmmol1cm1;
c solution molar concentrationmmol/ml;
b solution thicknesscm;
Solution thickness(b), is the light path is fixed and already known. Solution molar
absorptivityis the factor related to wavelength, solution and solution
concentration, when keep the solution concentration stable and under a certain
wavelength, the solution concentration and the absorbance present the linearity
relationship (the reagents manufacture will give thedirectly) .

When the waiting to be tested sample is equally-distributed solution, the function


between it and the indent light monochromatic is only the absorb process, and it
wont happen fluorescence, dispersion and photochemistry phenomenon, during
the absorb procedure, each material in the solution will not have any interaction,
and each materials absorbance have additivity, all these terms are totally accord
with Lambert-Beer Law.

4.2.1 Type of analytical methods

Analytical Photometry Absorbance


Cuvette Gap
Methods Point Computational Formula

One-point L 0 B1 B2 AL AL 1
endpoint
1L49 2 2
method

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Two-point L M B1 B2 (AM AM 1) k(AL AL 1)


endpoint
1LM49 2 2
method

AM AM 1 AL AL 1
Two-point L M B1 B2
Kinetics 1LM49 2 2
2
t
L M
B1 B2
Kinetics A 1LM49 A(M L)
L+2M 2

LM photometry point

B cuvette gap
(B1 B2) / 2 the mean value for twice cuvette gap

Ax the absorbance on photometry point X


A(M L) the changing of absorbance each minute between photometry
point L and photometry point M
k the correction factor of liquid volume
a
S Ri
k i 1
b
S Rj
j1

S Sample volume
Ri Rj a is unrevised reagent volume,b is revised reagent volume.

Attention

As to the unused photometry point, please be sure to input 0

During the photometry, the reaction liquid volume should be more than or
equal to 200ul, and less or equal to 450ul.

1 One-point Endpoint Method


After adding the sample and reagent, test the absorbance on a certain
photometry point, to measure the sample concentration, this method is One-point
Endpoint Method, the reaction curve as shown below:

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Picture 4.2.1.1 One-point Endpoint Method reaction curve

aphotometry pointL-0
here 1L 49
bThe calculation for absorbance
Get the mean value of absorbance for photometry point L and L-1,Computational
Formula is as following
AL AL - 1
Ax
2
cThe calculation for concentration
Cx {K (Ax - B) C1} IFA IFB
CX is waiting to be tested sample concentrationC1 is No.1 calibration(reagent gap)
concentrationK is K factorB is absorbance of reagent gapIFA and IFB are the
constant of the analyzer stands for rake ratio and section
dAnalytical item: for example TP, ALB etc

2Two-point Endpoint Method


Before the reaction for the being tested material not begin, choose the first
photometry point, and when the reaction achieves the end or becomes balance,
choose the second photometry point, use the difference on absorbance for two
photometry points to measure the sample concentration, is called Two-point
endpoint method, the reaction curve is as following:

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Picture 4.2.1.2 Two-point endpoint method reaction curve

aphotometry pointL-Mhere 1LM49


bThe calculation for absorbance
The mean value of the absorbance of the photometry point M and M-1 to subtract
the mean value of the absorbance of the photometry point L and L-1, take their
difference as absorbance, Computational Formula is as following
(AM AM 1) k(AL AL 1)
Ax
2
and
a
S Ri
k i 1
b
S Rj
j1

a reagent quantity when testing AL


b reagent quantity when testing Am
cThe calculation for concentration
Cx {K (Ax - B) C1} IFA IFB
CX is waiting to be tested sample concentrationC1 is No.1 calibration(reagent gap)
concentrationK is K factor, B is absorbance of reagent gapIFA and IFB are the
constant of the analyzerstands for rake ratio and section
dAnalytical item: for example enzymatic CREA etc

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3Two-point Kinetics
Test two photometry points, these Two-points is neither the initial absorbance nor
the end absorbance, calculate the difference of the absorbance between
Two-points in a unit time so as to calculate the sample concentration, this is called
Two-point kinetics, the reaction curve is as following:

Picture 4.2.1.3 Two-point Kinetics Reaction Curve

aphotometry pointL-Mhere 1LM49


bThe calculation for absorbance
The mean value of the absorbance of the photometry point M and M-1 to subtract
the mean value of the absorbance of the photometry point L and L-1, take their
difference to divide time as absorbance, Computational Formula is as following
AM AM 1 AL AL 1

Ax 2 2
t
Here
ttime interval(minute) between of photometry point L and M.
cThe calculation for concentration
Cx {K (Ax - B) C1} IFA IFB
CX is waiting to be tested sample concentrationC1 is No.1 calibration(reagent gap)
concentrationK is K factor, B is absorbance of reagent gapIFA and IFB are the
constant of the analyzerstands for rake ratio and section
dAnalytical item: BUN, picric acid method CREA, etc

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4Kinetics A
According to the change rate of the absorbance between two photometry points in
unit minute to calculate the concentration or activity value, this is called Kinetics A,
reaction curve is as following

Picture 4.2.1.4 Kinetics A reaction curcve

aphotometry pointL-Mhere 1LM49L+2M


bThe calculation for absorbance
Use the least square method to get the change rate of the absorbance for
photometry point L and M in unit minute.
Ax A(M L)
cThe calculation for concentration
Cx {K (Ax - B) C1} IFA IFB
CX is waiting to be tested sample concentrationC1 is No.1 calibration(reagent gap)
concentrationK is K factor, B is absorbance of reagent gapIFA and IFB are the
constant of the analyzerstands for rake ratio and section
dAnalytical item: ALT, AST,etc.

4.2.2 Calibration method

1One-point linearity method (K-factor method)


Get the working curve through measuring the calibration solution 1s (reagent gap)
absorbance and the inputting the K-factor, calibration curves is as following:

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Picture 4.2.2.1 One-point linearity calibration curve

aInput of "Calibration parameters"


Calibration types: One-point linearity method
Calibration point: 1 (calibration solution quantity)
bConfirm K factor:
Input K factor in the calibration results forms
cThe calculation for parameters:
B :The absorbance of calibration solution 1(reagent gap) or the change
rate of absorbance in a unit minute.
C1 :Input the concentration of calibration solution 1(reagent gap)
K :Input value
dThe calculation for concentration:
Cx {K (Ax - B) C1} IFA IFB
Cx is the waiting to be tested sample concentrationAx is the sample absorbance
or the rate of change of absorbance in a unit minuteIFA and IFB are the constant
of the analyzerstands for rake ratio and section

eApplicative analytical methods:


One-point End Point Method, Two-point End Point Method, Two-point Kinetics,
Kinetics A Method.

2Two-point Linearity Method


Through the measurement of the calibration solution 1 (reagent gap) and solution 2
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SUNMATIK-6020 Users manual

to get the working curve ,the calibration curves is as following:

Picture 4.2.2.2 Two-point Linearity Method calibration curve

aInput of "Calibration parameters"


Calibration types: Two-point linearity method
Calibration point: 2 (calibration solution quantity)

bThe calculation for parameters


B :The absorbance for calibration solution 1(reagent gap) or the change
rate of absorbance in a unit minute.
A2 :The absorbance of calibration solution 2 or the change rate of
absorbance in a unit minute.
C1 Input the concentration of calibration solution 1(reagent gap)
C2 Input the concentration of calibration solution 2
C1 - C2
K K
A2 - B
A2 - B
b b B-( ) C1
C2 - C1
cCalculation of concentration
Cx {K (Ax - B) C1} IFA IFB
Here Cx means Concentration of the being tested sample, Ax is the absorbance of
the sample or the change in absorbance per minute, IFA and IFB is the constant of
instrument, stand for the slope and intercept.

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dAnalytical methods applied:.

one-point end-point method, two-point end-point method, two-point kinetics


method, Kinetics A Method.

3Multi-point linear method


By measuring calibration solution 1 (reagent blank) and calibration solution
(2-6), to get the linear working curve, the calibration curve as shown below

Picture 4.2.2.3 Multi-point linear calibration curve

a"Calibration parameters" inputting:


Calibration type: Multi-point linear method
Calibration point: 3-6 (the quantity of calibration solution.)
bParameters calculation
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.
AN The absorbance of the calibration solution N or the absorbance
changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank).
CN Input the concentration of calibration solution N.
Kb be automatically calculated by linear regression.

cCalculation of concentration

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Cx {K (Ax - B) C1} IFA IFB


Here Cx means Concentration of the being tested sample, Ax is the absorbance of
the sample or the change in absorbance per minute, IFA and IFB is the constant of
instrument, stand for the slope and intercept.

dAnalytical methods applied:.


one-point end-point method, two-point end-point method, two-point kinetics method,
Kinetics A method.

4Logit-Log 4PNon-linear Method


Suit for reactions which absorbance appears a convergence trend comply with
increased concentration, the calibration curve as shown below

Picture 4.2.2.4 Logit-Log 4P Calibration curve

a"Calibration parameters" inputting:

Calibration typeLogit-Log 4P
Calibration point4-6the quantity of calibration solution.
bParameters calculation

B the absorbance of calibration solution 1 (reagent blank) or the


absorbance changing rates per minute.
An The absorbance of the calibration solution N or the absorbance
changing rates per minute.

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C1 Input the concentration of calibration solution 1 (reagent blank)..


CN Input the concentration of calibration solution N.
Kab : approximate constant could be automatically calculated.

cCalculation of concentration
Cx (C C1) IFA IFB
K
Ax B
1 exp(a b ln C)
Here C is calculated by the quasi-Newton method.
Here Cx means Concentration of the being tested sample, Ax is the absorbance of
the sample or the change in absorbance per minute, IFA and IFB is the constant of
instrument, stand for the slope and intercept.

dAnalytical methods applied:.


one-point end-point method, two-point end-point method, two-point kinetics method,
rate A method.

5Logit-Log 5PNonlinear method


It has the same characteristics with Logit-log4P, because this method has an extra
parameter, in some cases, the results become more accurate, the calibration curve
as shown below:

Picture 4.2.2.5 Logit-Log 5P calibration curve

a"Calibration parameters" inputting:

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SUNMATIK-6020 Users manual

Calibration typeLogit-Log 5P
Calibration point5-6the quantity of calibration solution.
bParameters calculation
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.
An The absorbance of the calibration solution N or the absorbance
changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank).
CN Input the concentration of calibration solution N.
Kab : approximate constant could be automatically calculated.

cCalculation of concentration
Cx (C C1) IFA IFB
K
Ax B
1 exp(a b ln C c C)
Here C is calculated by the quasi-Newton method.
Here Cx Concentration for the test sample, Ax is the absorbance of the sample or
change in absorbance per minute, IFA and IFB is the instrument constant, that
slope and intercept.

dAnalytical methods applied:.


one-point end-point method, two-point end-point method, two-point kinetics method,
Kinetics A method.

6Index method(non-linear method)


Suit for reactions which absorbance appears a disperse trend comply with
increased concentration, the calibration curve as shown below:

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SUNMATIK-6020 Users manual

Picture 4.2.2.6 Index calibration curve

a"Calibration parameters" inputting:


Calibration typeIndex
Calibration point5-6the quantity of calibration solution.
bParameters calculation
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.
An The absorbance of the calibration solution N or the absorbance
changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank)..
CN Input the concentration of calibration solution N.
Kab approximate constant could be automatically calculated.

cCalculation of concentration
Cx (C C1) IFA IFB

Ax B K exp{a lnC b (lnC) 2 c (lnC) 3 }


Here C is calculated by the quasi-Newton method.
Here Cx Concentration for the test sample, Ax is the absorbance of the sample or
change in absorbance per minute, IFA and IFB is the instrument constant, that
slope and intercept.

dAnalytical methods applied:.


one-point end-point method, two-point end-point method, two-point kinetics method,
Kenetics A method.

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7Polynomial method (non-linear method


Suit for reactions in which the absorbance will decrease comply with increased
concentration, the calibration curve as shown below:

Picture 4.2.2.7 Polynomial calibration curve

a"Calibration parameters" inputting:


Calibration typePolynomial
Calibration point4-6the quantity of calibration solution.
bParameters calculation
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.
An The absorbance of the calibration solution N or the absorbance
changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank).
CN Input the concentration of calibration solution N.
Kab approximate constant could be automatically calculated.

cCalculation of concentration
Cx (C C1) IFA IFB

Ax a b C c C 2 d C 3
Here C is calculated by the quasi-Newton method.

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SUNMATIK-6020 Users manual

Here Cx Concentration for the test sample, Ax is the absorbance of the sample or
change in absorbance per minute, IFA and IFB is the instrument constant, that
slope and intercept.

dAnalytical methods applied:.


one-point end-point method, two-point end-point method, two-point kinetics method,
Kenetics A method.
8Parabola method (non-linear method)
Suit for reactions which absorbance appears a disperse trend comply with
increased concentration, the calibration curve as shown below:

Picture 4.2.2.8 Calibration curve of parabola method

a"Calibration parameters" inputting:


Calibration typeParabola
Calibration point3-6the quantity of calibration solution.
bParameters calculation
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.
An The absorbance of the calibration solution N or the absorbance
changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank)..
CN Input the concentration of calibration solution N.

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Kab approximate constant could be automatically calculated.

cCalculation of concentration
Cx (C C1) IFA IFB

Ax a b C c C 2
Here C is calculated by the quasi-Newton method.
Here Cx Concentration for the test sample, Ax is the absorbance of the sample or
change in absorbance per minute, IFA and IFB is the instrument constant, that
slope and intercept.

dAnalytical methods applied:

one-point end-point method, two-point end-point method, two-point kinetics method,


Kinetics A method.

9Spline method (non-linear method)


Suit for reactions in which the absorbance will decrease comply with increased
concentration, the calibration curve as shown below

Picture 4.2.2.9 Calibration curve of spline method


a"Calibration parameters" inputting:
Calibration typeSpline
Calibration point5-6the quantity of calibration solution.
bParameter calculations
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.

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An The absorbance of the calibration solution N or the absorbance


changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank)..
CN Input the concentration of calibration solution N.
a(I)b(I)c(I)d(I) approximate constant could be automatically calculated.

cCalculation of concentration
Cx (C C1) IFA IFB

Ax a(I) b(I) (C - C(I)) c(I) (C - C(I)) 2 d(I) (C - C(I)) 3


Here C is calculated by the quasi-Newton method.
Here Cx Concentration for the test sample, Ax is the absorbance of the sample or
change in absorbance per minute, IFA and IFB is the instrument constant, that
slope and intercept.

dAnalytical methods applied:.


one-point end-point method, two-point end-point method, two-point kinetics method,
Kenetics A method.

4.2.3 Calibration type

We provide two different kind of calibration solution type according to different


quantity of calibration solution.The blank calibration which only calibrates the
calibration solution 1(reagent blank) and the all points calibration which calibrates
with all setting calibration solution.You could choose it according to different
requires.

Attention

When you input 1 on the quantity of calibration solution(K factor method),


could only execute blank calibration..

4.3 The Checking of test status


This instrument could execute a variety of inspections,aim at reaction status and
testing values,in order to improve the reliability of test data.

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4.3.1 The checking on calibration

When doing the calibration analysis, you can execute variety of checking to
calibration items, such as the checking of blank level, the checking of
discreteness, the checking of sensitivity, the checking of dirft rate.

1The checking of blank level


On calibrating procedure,when the two times tested average value of the
calibration solution 1s absorbance exceeds the setting range of blank level
checking,there will be an alarm which alarms that the blank level checking of
reagent has exceeded(The alarm level is:Note).
For the alarming analysis item,it's calibration reaction curve will be renewed,the K
value will not be renewed,you could select to not execute this item.
2The checking of discreteness
On calibrating procedure,each calibration solution(including reagent blank,which is
calibration solution 1) should be tested by two times,and take their average value.If
the difference of absorbance between two times tested is greater than the setting
value of the discreteness checking, there will be an alarm which alarms that value
of discreteness has exceeded(The alarm level is:Note).
For the alarming analysis item,it's calibration reaction curve will be renewed,the K
value will not be renewed,you could select to not execute this item.
3The checking of sensitivity
On calibrating procedure(Multi-point linear and non-linear),if the difference between
the absorbance of calibration reagent 1(the average value of absorbance tested by
two times) and the absorbance of the calibration solution with highest
concentration(the average value of absorbance tested by two times) is less than
the setting value of the sensitivity checking, there will be an alarm which alarms
that value of sensitivity checking has exceeded(The alarm level is:Note).
For the alarming analysis item,it's calibration reaction curve will be renewed,the K
value will not be renewed,you could select to not execute this item.
4The checking of drift rate
On calibrating procedure(Multi-point linear and non-linear),the difference between
the approximately calculated absorbance of each concentration and the

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absorbance gets from test exceeds the setting value of the dift rate checking, there
will be an alarm which alarms that value of drift rate checking has exceeded(The
alarm level is:Note).
For the alarming analysis item,it's calibration reaction curve will be renewed,the K
value will not be renewed,you could select to not execute this item.

4.3.2 The checking of absorbance limit

For items which use Kinetics A method or two-point kinetics method,when the
concentration exceeds the setting range,the instrument cant get the correct
data.So,you could set the upper limit value and lower limit value of absorbance,in
order to check,and give an alarm message.

When there are four or above four tested absorbance dont fit the setting values of
absorbance,instrument will give an alarm.As shown below:

Picture 4.3.2.1 Absorbance limit

4.3.3 The linear checking to reaction

On the reaction of Kinetics A method,the change of absorbance should present a


linear relation with time.So we should make a checking to linear,once exceeds the
limit,there will be an alarm message.
1When the range of metering point is above 9N9
The principle for linear checking is to use the least square method, when N 9,we
use the difference of absorbance changing between the front 6 points and back 6
points to divide the average of all absorbance variable,to proceed the linear
checking.If the get value exceeds the linear checking value,the instrument will give
an alarm message.

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A1 A2
100 > the input value for linear limit%
A

Picture 4.3.3.1 linear checking N9

2When the range of metering point is 4 to 8 4N8


When 4 N 8, we use the difference of absorbance changing between the front 3
points and back 3 points to divide the average of all absorbance variable,to
proceed the linear checking.If the get value exceeds the linear checking value,the
instrument will give an alarm message.

A1 A2
100 > the input value for linear limit%
A

Picture 4.3.3.2 linear checking 4N8

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When the metering points within reaction limit is within 3N3.

A 0.006 or A1 A2 0.006.

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5.The operation of software

5.1 Composition of the form

The software interface is mainly constituted by status bar,primary key area,working


area,tips column,shortcut area.

a Status Bar: displays the current state of system, including instrument


status, reaction temperature, the user, current time.
Instrument status includes: online, offline, standby, testing, washing,
self-test, and scaning..Temperature area shows the real-time
temperature of reaction tank, the user area shows the operators name of
the current software.
b Primary key area:here places the main functional buttons of software,
you could click to enter into relevant working area.
c Working area: users could enter into his choosing interface according
to which function this user chooses.
d Shortcut area:here places several frequently-used functional buttons.
e Tips column: used to point out if users operation is successful,or the
reason of errors.

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5.2 How to operate the interface elements

aThe operation of textbox


Click the textbox with mouse, move the cursor to the textbox and then input the
data.
b The operation of functional button
Click the functional button to execute relevant functions.
cThe operation of right mouse menu
Click the right mouse button on specific area,the right mouse menu will popped up,
click different menu item,to execute the relevant function.

d The operation of listbox and scroll bar


If you want to choose multiple records within the list, there are two ways to achieve:
one is to press on the shift key, and then click start record and end record in list,
now all records within the area are chosen.The other way is press on the Ctrl key,
then separately click the record from list, now your clicked records will be chosen.
If the number of records are too more, or the width is limited,cant completely show
all the records,now you could view the content by dragging the vertical or
horizontal scroll bar.

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eThe operation of the drop-down list


Click the arrow on the right of drop-down list,to open or close the dropdown list.By
using the drop-down list,more information could be shown.Once you have choose
an item,this chosen item will be showed on the first column,at the same time, the
drop-down list will disappear.box arrow to the right to open or close the drop-down
list box.Use the drop down list box to display more information.

f The operation of radio buttons and check boxes


Radio butttons:you could only choose one function from multiple functions.

Check boxes: You can simultaneously choose two or above functions.

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6 Detailed Operation

This chapter mainly introduce the basic operational procedure of system,after


studying this chapter,the user could fulfill daily operational process by using this.

6.1 Daily operational process

6.2 The preparation before analysis

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6.2.1 Check before start

Before starting the instrument,please execute the following routine inspections, to


ensure after starting up,the instrument could be operated normally.

Biological pollution hazard:


When proceed the following inspection, make sure to wear gloves, wear
overalls to avoid being infected, on occasion, please wear protective
glasses.

1 .Check if the power voltage is normal, and if the serial cable is well connected
with computer.If the alarm signal cable of each barrel connected solid with system.
2 .Check whether the waste liquid in the waste barrel is dumped.And if there is
enough distilled water and washing solution in each barrel.
3. Check the appearance state of sample needle / mixing needle / washing unit /
reagent/sample tray /reaction tray.
4 .Check if there is enough water for refrigeration cycle.

6.2.2 Starting up

After you finished above checking and confirmed,please turn on the power
switch according to the following orders:
1 The power switch of analysis part
2 The power switch of refrigerating system(if necessary)
3 The control parts (computer) switch / monitors switch
4 The power switch of printer

6.2.3 Start the control Software of analyzer

1. After logging in Windows operating system, double-click the shortcut icon of


control software Or choose the control software program from the [Start]
position, to start the control software, enter into following login window as shown
below.

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Attention
The default user name is"admin", password is empty.

Input user name and password,click or Enter,to enter into the main

form of software, when you click then you cancel the Login

After successfully login, if you want to exit the software, click the " "
button on the shortcut area.
Only on the offline state,you could execute the exiting operation. If the instrument is

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on the status of online, click " " button,and then exit the system.
After successfully login the software,at the moment of just enter into software,the
status is offline, that is, software is not connected with equipment, the status bar
shows "offline".At this time,you could view the forms on functional area,
At this time, you can view the functional areas of the form, the user log off and

exit;users logging off and exiting,click button,if there is no abnormal on


instrument,the status bar will show a standby status.Now you could execute all the
operations,and test functions.

6.2.4 Confirm the status of instrument

1Confirm the alarm information


In the "Alarm information" form, check if there is a new alarm information, if
exist,please deal with it in time.We suggest you to delete the alarm informations
which you have already dealed with,in order to avoid too much informations in
list,which influences the reviewing of information.Detailed operations,please refer
to the section of 15.1 Confirmation of alarm message
2Confirm the cuvette blank
In the "cuvette" form, send a cleaning command,the instrument will clean the
cuvettes, at the same time,proceed a cuvette blank checking,if there are many
cuvettes which dont meet the inspection requirement,please consider to replace
the cuvettes.Detailed operations, please refer to the section of "13.4 cuvette
cleaning"
New cuvettes shoud be soaked above 8 hours before installation, and then
repeatedly washed with tap water, then rinse with pure water,after that they could
be installed to reaction tray.
3Confirm the temperature of raction tank
Observe the temperature display in the status bar of main interface, check whether
the temperature in the reaction tank is (370.1) .On the test procedure,if the
temperature exceeds range of (370.5) ,the alarm message on note level will
occur, the instrument will continue to analysis.On the standby status,if the
temperature of reaction tank exceeds 45 ,the instrument will give a note level

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alarm.

6.2.5 Confirm the analytical conditions

Before the test,firstly is to add the analysis item,then to set the analysis
parameter,calibration parameter,QC parameter.
The parameter setting,how to use ,attentions and store method for the
reagent,calibration solution and QC solution,please take the instructions for
reference,or consult to manufacture or distributor.
1The setting of analysis item
In the "analysis item" form,you could add,modify,delete the analysis item,and
execute the setting or confirming of analysis parameter according to reagent
instructions.Some parameter is the necessary condition for tests.Detailed
operations,please take section of 11.1 Analysis item for reference.
2The setting of combination item
The so-called combination item means to combine the relevant items together,for
example,to do the full set of liver function,the full set of renal function,you only need
to click the name of combination item that could finish the registration function for
multi items,it is convenient to speed the entering process.
In the "portfolio" form,you could set the combination item, Detailed
operations,please take section of 11.2 Combination item for reference.
3The setting of computational item
Computational item means to calculate the test result of one new item according to
the test results of item A,item B,or more item.
In the "Computational item" form, you could set the computational item, Detailed
operations,please take section of 11.3 Computational item for reference.
4The setting of cross contamination
Cross contamination is a function which could reduce or avoid the cross
contamination between analysis items.
In the "cross contamination" form,you could set the cross contamination, Detailed
operations,please take section of 11.5 Cross contamination for reference.

6.2.6 The preparation of reagent

Input the reagent information correctly,check the using of reagent is correct,if put

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the reagent to a right place,if there is a barcode on the reagent bottle,please check
if there exists contamination to barcode sticker or if it falls off.Detailed
Correct input reagents, confirming that the reagents used correctly, is placed in the
correct location, such as the reagent bottle with a bar code, make sure there is no
pollution or bar code stickers off. Detailed operations,please take chapter of 10
reagent information for reference.

6.2.7 The application of test task

There are there kinds of test task,they are:sample test,calibration test,QC test.The
detailed operations for application of sample test,please take section of 7.1 sample
registration for reference, The detailed operations for application of calibration
test, ,please take section of 8.1 calibration registration for reference. The detailed
operations for application of QC test, ,please take section of 9.1 QC registration
for reference.When finished the application of test task,please click shortcut key
start test that the instrument starts to test.

6.3 Under testing process

6.3.1 System monitoring

On the sample testing process, you could proceed a real-time monitoring to sample
tray,reaction tray,reagent tray. Detailed operations,please take chapter of 14
System monitoring for reference.

6.3.2 Suspend adding sample or continue

During test process, if you want to add some reagent, or add some samples, you
could suspend adding sample,click Suspend adding sample button,the instrument
will stop adding sample,after suspending if you wan to test again,you should click
continue adding sample button.

6.3.3 Emergency stop

During test process, click the "emergency stop" button, the instrument will
immediately stop the current action.When instrument is under self-testing or bar
code scanning, the emergency stop is not allowed.

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6.3.4 Add additional sample

During the test process, you could edit the other sample in sample registration
form by clicking task application button to send test task.

6.4 Confirmation of test results

In the "test results" form,you could view,add,modify,delete,review,audit and printing


the test result, detailed operations,please take chapter of 7.3 Test result for
reference.

Attention

Sample with hemolysis, lipemia, jaundice will affect the test results.
Some substances in samples, such as drugs, anticoagulants,
preservatives, etc. will affect the test results.
Incorrect parameter settings will affect test results.

6.5 Finish analysis


6.5.1 Exit the control software

When all the test tasks are finished,the system is under standby status,click Exit
the system in main interface,you could exit the control software.
.
Attention

Before exiting the system,please firstly proceed to wash cuvettes.

6.5.2 Power off

After exiting the control software,please turn off the following powers in turn
1 Power of printer
2 Power of display
3 Power of analysis part

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4 Power of cooling system (if necessary)

6.5.3 Operation after power off

NOTE
When operating, be sure to wear gloves, wear overalls to avoid being
infected, if necessary, wear protective glasses.

1 Cover the each lid of reagent bottle on the sample / reagent tray,if you truned
off the the power of cooling system,you need to put reagent into the
refrigerator.
2 Clean up the samples,calibration solution and QC solutions on the sample /
reagent tray.
3 Empty the residue leaves in the waste barrel.Check the volume of
regrigerating circulating water, if not sufficient,please add some.
4 Check whether the table of analysis part stained, if so, please wipe off with a
clean soft cloth.

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7 Sample test

Sample test mainly contains the functions of sample registration,patient


information,test results,result query.

Click the sample test button " " in main interface to enter "Sample Test"
interface, as shown below:

7.1 Sample register


Click on "Sample Register" option to enter into the sample register interface.This
interface can be a single sample and bulk samples for registration.

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a In the "sample number" input box enter the sample number, starting and
ending numbers if the same single sample representative of the registration,
if different, the representative bulk samples of registration.
b In the "Sample Position" input box enter the sample position, if it is bulk
registration, the site of the sample will automatically accumulate.
c In the "repeat" input box enter the number of samples tested, and if the
starting and ending sample numbers are the same, using the same sample
location, sample number automatically accumulate, if different, the number
of repetitions can only enter "1."
d Enter the sample type, sample status, bar code, and other information.
e If the emergency registration of samples, select the "STAT" option.
f If need to dilute the sample, select the "dilute" option.
g If the samples need to detect the sample blank, select the "sample blank"
option.
h Selected in the list to test all items, functions can also be used to detect the
Portfolio feature selection.
i Click the " Apply" button to complete the task of testing applications.
j If you want to delete the test task, first select the task in the task list, then
click the "Cancel" button.

Attention

Registered but no send a test sample of the testing process in both standby

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and can be modified and deleted.


Registration and send a test sample has been carried out only in standby until
the next sample can be removed.

7.2 Patient Information

Click"patient information" to enter into the editing interface of patient information.

a Input the sample number in sample number input box,if the sample number
has existed in dropdown list,you could select it directly.
b Input or select the patient name, sex, age or the other informations.The
name must be inputed.
c Finish editing, click "Add" button.Patients name will be automatically
displayed in the task list of sample tests.
d If you want to delete the patients information, firstly select the sample
number from dropdown list, then click the "Delete" button.

Attention

If you firstly proceed the sample registration,the sample position showed in tast
list is 0,please revised to be the right sample position when doing sample
registration.

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7.3 Test Result


Click "Test Result" to enter into the test result interface.You could execute
functions of view, add to,modify,delete,check,audit,print to test results.

7.3.1 View the results

The sample information list shows all the sample information on that day,click some
sample information,then all the test results of this sample will be shown on sample
result list.
If you want to check the previous test results,you could change the test date,then
all the sample informations on that day will be shown on sample information
list,after click the sample information,you could view the test results.

7.3.2 Add to the results

a Click the sample information in the list,click right-hand button in the blank of
result list,chooseadd from popup menu,enter into editing interface of test
result.

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b Choose informations of item type (analysis item,manual item),item,inputing


item from dropdown list.
c Click "Save" button.

7.3.3 Modify the result

a Click the sample information in the list, right-hand click the test record which
needs to be modified from test list,choosemodify from popup menu,enter
into editing interface of test result.

b Input the modified test result.


c Click "Save" button.

7.3.4 Delete the result

a Click the sample information in the list, right-hand click the test record which
needs to be deleted from test list,choosedelete from popup menu.

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b Click "Yes" button from the popup dialog box.

7.3.5 Audit the sample

Click "Audit" button to enter the batch auditing interface.

Input the start and end sample number, then click "audit" button to complete the
auditing of the sample.

Attention

The sample information must firstly have a result and name,then it could be
audited.
On the batch auditing process, the starting sample number must be less than or
equal to the end sample number.

7.3.6 Print the report

Click "Print" button to enter into the batch printing interface.

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Enter the start and the end sample number, then click"Print" button to complete the
printing of report.You could also only print the already audited report by choosing.

7.3.7 The view of reaction curve

Click"reaction curve" button, enter the viewing interface of reaction curve.

a Choose the sample number,test item,display mode of dominant


wavelength or vice wavelength,then the reaction curve of this item will be
shown.
b If you want to view the absorbance value of a metering point,choose the
"Point" from dropdown list,then the absorbance value of this metering
point will be shown.
c You could print the reaction curve chart by clicking "Print" button.

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7.3.8 Retest the sample

There are two registrating way to the retesting of sample, they are automatic
registration and manual registration, the retesting will not change the sample
number, but you can reset the volume type of sample " (normal volume, increment,
decrement) on Retest form.
Click "Retest" button, enter the settings interface of retest item.

1 Automatic Registration
Click "Retest" button, enter "retest item setup" interface.After finish sample
testing,the instrument will automatically add the sample information which fulfill the
retest conditions to retest form according to the retest setting conditions,the
operator could change the volume type of sample " (normal volume, increment,
decrement),and make the dilution setting.Click Save button.The relation between
sample volume type and sample volume as shown below:

The conditions for automatically registration Sample volume type

exceed the lower limit of linear range increment

exceed the upper limit of linear range decrement

reaction absorbance limit exceeds decrement

reaction absorbance limit exceeds 3.0ABS decrement

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2 Manual registration
After the first time test,if some samples need to be retested,clickRetest from test
result list,this item will be added to the retest list.Check the volume type of the
retest sample or if it needs to be diluted,click Save button.
Confirm the retest sample in "reset item setup" form, click on the "Apply" button to
apply the retest task.

Attention

Only the test results on that day can be retested.


You must firstly apply the retest task, then you could retest.

7.4 Query the Result


Click "Result Query " button to enter into the querying of results interface.
Under this interface,you could query the results by sample, you could also query
the results by item.

7.4.1 Query by sample

Click Sample Query" to enter into the query by sample interface.

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a Input the start date and end date, input the name, sample number, barcode
number, medical record number,the querying condition could be only one, or
it can be more.
b Click "Query" button,then you will check out the eligible sample information.
c Click a record from the sample information list,then the test result of this
sample will be shown in the test results list.
d If you want to modify, delete the sample information, right-click the sample
information list, click different menu item,you could complete this operation
respectively.
e If you want to add, modify, delete the test results, right-click the sample
information list, click different menu item,you could complete this operation
respectively.
f You could print the querying results by clicking the "Print" button.

7.4.2 Query by item

Click "Item Query" to enter into the query by item interface.

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(a)Input the start date and end date, input the start sample number and end sample
number, choose the test item.
(b)Click the query button, you will get the test results that meet the conditions.
(c)Click "Check All" check box,now all test results in list were selected, you can also
cancel all.
(d)If you want to make batch modification to test results,you could input the values
in the correcting parameter input box.
(e)Click "Modify" button, then all the test results in list will be modified according to
the modifier formula.
(f)Click "Repeatability" button, all the test results in list will be on the statistics,work
out the maximum value, minimum value, range, average value, standard
deviation, coefficient of variation.

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8 Items calibration

Items i calibration mainly contains functions of calibration registration, calibration


results querying.

Click item calibration button " ", enter "Calibration" interface, as shown
below:

8.1 Calibration register


Click "Calibration Register" option to enter into the calibration register interface.
You could apply for the calibration tasks in this interface.

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(a)Choose the test item which needs to be calibrated.


(b)Choose the calibration type from dropdown list.
(c)Click the "Apply" button.
(d)If you want to delete a calibration task, firstly choose the task from task list,, then
click the "Cancel" button.

8.2 Calibration Result


Click "calibration result" option to enter into the calibration result interface.In this
interface you could view, modify, add, delete, print the test results, or view and print
the calibration curve and reaction curve.

8.2.1 The editing of calibration results

a If you need to add the calibration results, right-click the blank of the
list,select "Add" from the pop-up menu, entry into the editing interface of
calibration results, select the item from dropdown list, then input the
calibration results, click "Save" button.

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b If you need to modify the calibration results,right-click the item needs to be


modified,select "Modify" from the pop-up menu, entry into the editing
interface of calibration results, select the item from dropdown list, then input
the calibration results, click "Save" button.

c If you want to delete the calibration results, right-click the record needs to be
deleted,select "Delete" from the pop-up menu.
d You could preview and print the calibration results by clicking the "Print"
button.

8.2.2 View the calibration curve

Click calibration curvebutton,enter into the viewing of calibration curve interface.

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After choosing the item and standard liquid from dropdown list, data like calibration
curve,absorbance,calibration method, calibration results will be shown.

8.2.3 View the reaction curve

Click "reaction curve" button, enter into the viewing of reaction curve interface.

(a)Choose the item,calibration solution,times,display mode of dominant


wavelength or vice wavelength,then the reaction curve of this item will be
shown.

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(b)If you want to view the absorbance value of a metering point,choose the
"Point" from dropdown list,then the absorbance value of this metering point will
be shown.
(c)You could print the reaction curve chart by clicking "Print" button.

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9 Quality control

The aim to make quality control is in order to ensure the reliability of testing result
for each sample.The reliability of testing result contains two meanings,one is
precision,which means an excellent repeatability,and the small changes for daily
tests,mainly to eliminate or decrease the influence caused by random error;the
other is high accuracy,which means the testing result is correct,close to true
value,mainly to eliminate or decrease influence caused by systematic error.

Random error:means the difference of average values between test result and a
result which was gotten by infinate times tested under condition of
repeatability,called random error.

Systematic error:uder condition of repeatability,its the difference between a


average value which was tested by numerous times and the true value be
tested,called systematic error.Its a error component whos expectation is not zero.

Accuracy:its the integration from test result between systematic error and random
error,it stands for the consistence degree between test result and true value.

Precision:stands for the random errors degree of test results.precision means the
correspond degree of test results when limitless times testing.

L-JLevey JenningsQC chart:QC chart is one kind of graph with QC boundary.The

QC boundary is determined by the average valueX which is get from repeat test
of a known specimen by using QC analysis method and the standard deviation

SD . X 2 SD is Warning limit, X 3SD is out-of-control limit.

QC mainly contains functions of QC registration,QC result,intraday QC and


interday QC.

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Click QC button to enter into Quality Control interface,as shown


below:

9.1 QC register

ClickQC register button to enter into QC register interface.You could edit QC


information in this interface,you could also apply for a QC task.

(a) Input the name,lot number,target value,standard deviation and position of QC


solution.

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(b) Choose a QC item from dropdown list.


(c) Click Add button.
(d) If you want to delete a QC information,firstly choose this information from
list,then click Delete button.
(e) If you want to apply for a QC task,firstly choose this information from list,then
click Apply button.
(f) If you want to delete a QC task,firstly choose this task from list,then click
Cancel button.

9.2 QC result
Click QC result to enter into QC result interface.You could view,modify,add and
delete QC result.

(a) If you want to see the QC result for a particular month,please choose the QC
date,then all the QC results within this month will be shown in list.
(b) If you want to add a QC result,firstly choose the QC date,then choose
item,name,lot number,input the QC result,clickAdd button.
(c) If you want to modify a QC result,firstly choose this QC record,then input a
suitable QC result,click Modify button.
(d) If you want to delete a QC result,firstly choose this QC record,then clickDelete
button.
(e) You could view the reaction progress of QC test by clicking Reaction curve
button.

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(a) Choose the item,name,lot number,times from dropdown list,then choose the
display model of main wavelength and vice wavelength,now the reaction curve
of this item will be showed.
(b) If you want to see the absorbance value of one measuring point,choose the
detailed checking point from Point dropdown list,now this points absorbance
value will be showed.
(c) You could clickPrint button to print the reaction curve.

9.3 Intraday QC
ClickIntraday QC to enter into intraday QC interface.You could look at,analysis
and print the QC data of one particular day.

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(a) Choose QC date.


(b) Choose the QC item,QC name and QC lot number from dropdown list.
(c) When you finished choosing,this days QC data will be showed in QC chart,at
the same time,it will automatically calculate the actual measuring average
value,standard deviation, coefficient of variation and other data
(d) Click Analyze button,to proceed the out-of-control analysis to QC data by
using Westgard multi rule.
(e) Click Print button,you could print the QC data and QC chart.

9.4 Interday QC
ClickInterday QC to enter into interday QC interface.You could look at,analysis
and print the QC data of one particular month.

(a) Choose QC month.

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(b) Choose the QC item,QC name and QC lot number from dropdown list.
(c) When you finished choosing,this moths QC data will be showed in QC chart,at
the same time,it will automatically calculate the actual measuring average
value,standard deviation, coefficient of variation and other data
(d) Click Analyze button,to proceed the out-of-control analysis to QC data by
using Westgard multi rule.
(e) Click Print button,you could print the QC data and QC chart.

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10 Reagent information

10.1 The use of reagent and attentions


(a) The preparation,using and saving of reagent should under strict reagent
instructions,never make reagent have a bubble.Because reagent contains
surfactant,there will form up bubble,during the test procedure,if the liquid
sensor in the probe touches the bubble,it will make a wrong judgment to think
the probe has touched the reagent,which cause an inaccurate reagent
aspirating volume,it will influence the result.
(b) You should never renewal add new reagent.
If the renewal added reagent comes from different manufacturers or it comes
from the same manufacturer but of different batch,this may change reagent
ingredient,and cause an inaccurate result.
(c) Please open the reagent lid,put the reagent bottle to the right position of reagent
tray,if the reagent bottle has a barcode,please check if the barcode label is
contaminated or fall off.

10.2 The manual registration of reagent

Click reagent information button under main interface,enter into


reagent information setting interface,as shown below:

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(a) Input reagent bottles position,then input the range:1-44.


(b) Choose reagent name,reagent type from dropdown list,input reagent lot
number.
(c) If the barcode cant be scanned successfully because of the label is
contaminated or fall off,you could register the reagent information by manual
inputing,Click the check box of barcode number,input valid barcode of
reagent.
(d) Click Add button.
(e) If you want to delete reagent information,firstly choose information from
list,then click Delete button.

10.3 Reagent volume scan


Click Reagent Scan button,the instrument will automatically detect reagent
remaining volume and remaining test quantity,after detecting,the detected
information will be shown in list,once the remaining test quantity is 0 or the
remaining quantity is less than setting quantity,the instrument will marked with
yellow colour.

On the testing procedure,if the probe goes to aspirate reagent,this probe will detect
reagent remaining volume,at the same time, the reagent remaining volume and
remaining test quantity will be renewed.

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10.4 Barcode scan


When there is a barcode sticked on reagent bottle,and the barcode information is
clear and complete,you could use Barcode Scan to register reagent information
automatically.
ClickBarcode Scan button,the instrument will scan the reagent information
automatically,after finishing scanning,will show the reagent information(reagent
name,reagent type,reagent position and so on) to list.

Attention:
When the instrument is under testing procedure,dont execute reagent informations
registering and deleting.
When the instrument is under scanning procedure,dont make any other operation.
After register reagent information,please execute scanning the reagent volume before
testing,confirm the reagent remaining volume and remaining test quantity.

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11 System setting

System setting mainly contains functions of analytical item,combination


item,computational item,manual item,cross contamination,print setting.

Click System setup button to enter into System setup interface,as


shown below:

11.1 Analysis item


Click Analysis Item to enter into analysis item setting interface.You could edit
items parameter under this interface.
After correctly inputting item parameter,click Add button,to finish saving this
parameter,if you want to delete the item parameter,firstly choose this item from
list,then click Delete button.You could click Print button to preview and print the
items parameter.

11.1.1 Analysis paramter

Click Analysis Parameter to enter into analysis parameter setting interface.

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Item name :Items shortened form or abbreviation.

Print name:items name when printing.

Item no.:as the unique identification when scanning the barcode.


Assay:Choose an analyzing method which accord with reagent test requirement,
one point end point method,Kinetics A method, two-point end method,two point
kinetics method).
Unit:Choose unit of the resuilt.

Decimal:choose decimal digit of the test result,keep the decimal according to the
setting digit when printing and showing result.

Main/Second-wavelength:there are 10 wavelengths for choosing: 340 nm


405nm450 nm492nm510 nm546 nm578 nm620 nm670 nm700 nm.Please
choose the Main/Second-wavelength according to reagent instruction.If need to
use double wavelength to test,when calculating result,please calculate with the
absorbance of main wavelength minus absorbance of second wavelength or the
difference of absorbance variation ratio.
Factor:used to item which calibration method is linear,you could calculate the result
directly with calculation factor.

Instrument factor Y = aX + b:used to affine calibration,to check the consistency


between this analyzer and other analyzers.For the inspection of some items,the
test result of analyzer may be higher or lower then expected result or the results get
from other analyzers.In order to keep the test results consistency with expected

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result or the results get from other analyzers.


Y: calibrated result
X: actual result of analyzer
a: slope value (Multiplication calibration factor)
b: Intercept value(Compensation calibration factor)

While the analyzers test result is same as expected value,or the results get from
both analyzers are the same,then: a =1,b = 0.
Whlie the result of two instrument is different,you could calibrate with slope and
intercept value,to get a consistent value.
Sample volume setting:it contains normal volume,incremental
volume ,decremental volume,each one contains 3 input frame,they stands for in
turn:sample volume,sample original volume,dilute volume,the unit is microliter.
Normal volume:the normal volume of appointed sample.
Decremental volume(sample volume decrease):means the sample
volume(lower than normal volume)which concentration exceeds the upper limit of
reagent linear range.
Incremental volume(sample volume increase): means the sample
volume(higher than normal volume)which concentration exceeds the lower limit of
reagent linear range.
Sample volume:it is the sample volume sucked from sample container(sample
cup or test tube),it is 3-35 ul.The total volume for sample add reagent should be
equal or greater than 200 ul,and equal or less than 450 ul.
Dilution volume 1:If the sample is required a pre dilution,please set the sample
volume used to dilution.The input values are between: 15-35 ul.When the sample is
not required to be pre dilution,you dont need to input values here.
Dilution volume 2: If the sample is required a pre dilution,please set the dilution
volume.The input values are between: 30-350 ul, When the sample is not required
to be pre dilution,you dont need to input values here.
Reagent setting:includes reagent volume and reagent position.
Reagent volume:the unit is microliter,the reagent volume R1 is between 150-400
ul,the reagent volume R2 is between 20-200 ul,if it is single reagent,please dont
input reagent volume R2.
Position:its the reagent position on reagent tray,this parameter is registrated on
reagent information window.

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Metering point: The analyzer will record the absorbance value for every 12
seconds,which means every metering point amount to 12 seconds.Please input
suitable metering point according to reagent instructions,valid metering point shoud
be inputted between: 249(0 means not input).The actual absorbance value of
each metering point could be queried from reaction curve.
Linear range:Input the upper limit and lower limit of linear range according to
reagent instructions.If the test results exceed this range,the instrument will give an
alarm, you chould choose to not do this inspection.

Absorbance limit:set the limit values of absorbance inspecting,choose reaction


direction,once absorbance exceeds this limit will give an alarm,you chould choose
to not do this inspection.
Linear limit:on the method of Kinetics A.you could inspect the linearity,when
exceeds this limit will give an alarm,you chould choose to not do this inspection.

11.1.2 Reference range

Click Reference range to enter into reference range setting interface.

Specific reference value:If the age and sex of the patients are different,the
reference range is also different,now please use specific reference value
range.Click Specific value button,then to choose age unit,input the reference
range of different ago group and different sex.

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Default reference value: if the reference value for different patient with same age
and sex,the reference value is the same,now please use default reference value
range.Click default value button,then input reference range.

11.1.3 The other setup

Click Other Setup to enter into the other setup interface.Under this interface,you
could set relevant parameters of calibration and QC.

aCheck the calibration method,calibration point(calibration solution volume)


according to reagent instruction.
(b) Input the concentration and position of calibration solution.
(c) If you need to check drift rate,discreteness,sensitivity,blank level on the
calibration test,choose the relevant item and input suitable checking
values,the new added item dont execute above checking by default.
(d) When choosing the out of control judging condition,you should at least
choose one,the new added item will choose all the judging conditions by
default.

11.2 Profile item

Click Profile Item to enter into profile item setting interface.

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(a) Input the profile item name on profile item name input box.
(b) Choose the items you want to add.
(c) Click Add button.The combination name will be showed on the left list.Click
the name of profile item,all the items contained in this profile item will be
shown.

11.3 Calculated item


Calculated item means use the test reslt of two or more item,go through specific
calculation,be edit into another item which is new and some clinical significance.
such as A / G, TBil-DBil etc.

Click Calculated Item to enter into calculated item setting interface.

(a) Input parameters of item name,print name,unit,decimal digit etc.


(b) Use item code,figure,symbol to edit the computational formula of
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computational item,the edited formula will be shown on the textbox of


calculate formula.
(c) Click Add button,the computational formula will be successfully setted.
(d) If you want to delete a calculated item, please firstly choose this item from
list,then click Delete button.

11.4 Manual item


Manual item means an item which is not get from this analyzer but need to be
added the result to test result by hand.
ClickManual item to enter into manual item setting interface.

(a) Input parameters of item name,print name,item nature,qualitative


reference,unit,decimal digit,reference range,etc.
(b) Click Add button,the manual item will be successfully setted.
(c) If you want to delete a manual item,please firstly choose this item from list,then
click Delete button.

11.5 Cross contamination


The avoid of coress contamination is a function to decrease or avoid the cross
contamination between analysis items.For some items, the reason is reagent
formulas,the degree of coress contamination is different,in order to eliminate the
coress contamination between reagents,when users are presetting the item,please

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try to separate the coress contamination item with items of no coress


contamination.If cant completely separate them,you could avoid it according to
setting coress contamination,to effectively decrese the coress contamination
between items.But by using function of coress contamination will decrease the test
speed of instrument.

Click Coress Contamination to enter into coress contamination setting interface.

(a) Choose the item(from reagent) which one may cause a coress
contamination,choose relevant reagent type from type dropdown list.
(b) Choose the item(to reagent) which one may be contaminated, choose relevant
reagent type from type dropdown list.
(c) Click Add button,the setted information will be shown in list,now the coress
contamination of reagent will be successfully setted.
(d) If you want to delete a setting of coress contamination,please firstly choose the
information from list,then click Delete button.

11.6 Print setup


ClickPrint Setup to enter into print setup interface.

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11.6.1 Basic information setup

(a) Input title of report.


(b) Input remarks of report,it desnt need to be inputed if you dont print.
(c) Input hospitals address and tel, it desnt need to be inputed if you dont print.
(d) ClickSave button,to save the basic information.

11.6.2 Item order setup

(a) Choose an item.


(b) Move this item to a suitable position by using Up,Down,Top,Bottom.
(c) After arranged item orders,clickSave button.

11.6.3 Report format setup

(1) Report format choosing


(a) Choose one kind of report format from drop-down list,this style will be showed
on preview frame.
(b) ClickSave button.
2Report format editing
ClickEdit button to enter into report format editing interface.

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(a) Set the font size of tile and content.


(b) Choose the printing paper,there are 3 paper styles:A4,B5,customization.If you
want to customize paper size,please choose customization mode,at the same
time,input suitable values on width and height.
(c) Choose your printed information on option erea.
(d) ClickSave button.

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12 System management

The system management mainly contains functions of user information


management,data dictionary management,data maintenance,data
statistics,system log management and so on.

Click system management button ,enter into system management


interface,as shown below:

12.1 User information


ClickUser Information to enter into user information interface.Only users who has
administrator right could add,delete and revise users information.

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On the input frame,please set user name,password,confirm the password(keep


input the same password for two times),privilege,then clickadd button,now you
have set user information successfully,your edited information is showed in list,if
you want to delete user information,please click information and then click delete
button.
Administrator privilege:user could look at ,set and test all the functions of
instrument.
Operator privilege:user could look at all the functions,set partial functions,and
could execute function of testing.
Query privilege:user could look at partial functions,cant execute functions of
seting and testing.

12.2 Data dictionary


Click Data Dictionary to enter into data dictionary management interface.

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Firstly select data type,then input data in frame,clickadd button,now you have
added data information,if you want to delete the data information,please select the
information then clickdeletebutton.

12.3 Data maintemance


Click Data Maintemance to enter into Data maintemance interface,you could
backup or recovery data base,or export and clean up the data.

(a) ClickBackup button,the backup file will default to save to file


D:\BACKUP\,the file name is current date and time,the file format is:
*.sav,regularly backup the data base will protect data from missing.
(b) Select backup file from list,clickRestore button,you can fulfil the data base
recoverying,if the software could not used caused by some reasons,you could
recovery previous data by using backup data base file.

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(c) Select datasheet from list,clickExport button,you could export the data.
(d) Select datasheet from list,meanwhile select starting date and ending
date,clickClear button,you could clean up the data.

12.4 Data statistics


Click Data Statistics to enter into data statistics interface,you could statistics the
inspection department,inspection doctor and inspection doctors work-load.

Firstly select the starting date and ending date,then choose statistics type from
statistics type,click Statistics button to finish statistics anlysis,the result will be
showed in the form of a statistical chart.You could also click Print button to
preview and print this statistical chart.

12.5 System log


Click System Log to enter into system log management interface.You could look
at and manage the log in,operating log and maintaining log.

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Select the starting date and ending date,choose log type from log
type,click Query button,eligible logs information then would be showed in list,if
you want to delete the log information,firstly choose this information,then
click delete button.

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13 System maintenance

The system maintenance mainly contains communication setting,action


debug,parameter setting,cuvette washing and so on.

Click system maintenance button in main interface,enter into system


maintenance interface,as shown below:

13.1 Serial port setup


Clickcommunication setup to enter into interface of serial port setup, the mainly to
setting parameters are COM NO. and Baud rate.

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The default COM NO. is:COM 1,the default Baud rate is :38400,after finished
setting,please click Save button.

Attention:

Dont set the serial port when the instrument is running.


Your changed setting will come valid after restarting the online operation.

13.2 Action debug

ClickAction Debug to enter into interface of movement debugging,you could


detect each modules status in this interface,and debug each movement.
1Sample needles debugging (horizontally reset,vertically reset,to the position of
reagent 11,to the positon of reagent 2,to the sample position,to the cleaning well
positon,to reaction position,sample needles vertically movement,sample
needles cleaning),the cleaning time is:1-30 seconds.

2. Mixing needles debugging (horizontally reset,vertically reset, ,to the cleaning


well positon,to the reaction position, mixing needles vertically movement,debug
the mixing movement,mixing needles cleaning),the mixing time is :1-10
seconds,the cleaning time is:1-30 seconds.

3. Reagent trays debugging(reset,shift of reagent,shift of sample),the shifting


range is:1-44.
4. Reaction trays debugging(reset,shift,rotate),the shifting range is:1-44,stopping
range is:1-44.
5. Pipettes debugging(reset,aspirate liquid,spit liquid),the aspirating and spiting

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liquid range is:1-500


6. Washing modules debugging(reset,aspirating liquid,spit liquid).
7. Optical systems debugging(debug the signa. value of each wavelength).
8. Reset all:all the module of this instrument execute resetting movements.
9. Self-check:this function will check the status of each module.

Attention
The movement debugging could only be operated on standby status.
Dont engage any other activity on the instrument self-inspection process.

13.3 Instrument parameter


ClickInstrument Parameter to enter into instrument parameter setting
interface.You could set all kinds of operating parameter of instrument in this
interface,you could also upgrade the firmware here.

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(a) Select the part which you want to set parameter,input the correct parameter
value.
(b) ClickTest button,check if your setting is valid.
(c) If the setting is correct,please clickSave button.
(d) ClickDefault button to load the default parameters.

Attention
The instrument parameter setting could only be operated on standby status.
Dont engage any other activity on the instrument self-inspection process.

13.4 Cuvette cleaning


ClickCuvette to enter into cuvette cleaning interface,you could clean the cuvettes
in this interface,and you could also check the cuvette blank.

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The blank value of NO.0 cuvette is a value when all the light get through,it is sawn
as basic value,blank value of other cuvettes multiply 1.5 and then compare with this
basic value,if their difference is between 1000,it will be judged as a clean
cuvette,if beyond this range may consider to change a new cuvette.

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14 System monitoring

On the process of samples testing,you could exercise real time monitoring to the
sample/reagent disk,reaction disk of instrument.

Click button on the main interface,enter into interface of System


monitor,as shown below:

14.1 Sample disk status


Click Sample Disk to enter into sample disk status interface.

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Click the sample position which you want to check from sample disk monitor chart
or choose sample number from sample list,then relevant message will be showed
on the right browsing area.
Sample status:we use different colours to show different status of sample disk.
Free:sample in this position is not registered.
Wait:sample in this positon is registered,but not be added yet.
Analysis:a process for a registered sample from adding sample to before
getting result,all means anlysis status.
Finish:the sample haas gotten the test result.

14.2 Reagent disk status


Click Reagent Disk to enter into reagent disk status interface.

Click the reagent bottle position which you want to check from reagent tray monitor
chart,then relevant message will be showed on the right browsing area.

Reagent status:we use different colours to show different status of reagent disk.
Free:reagent is not used to current test.
Normal:reagent surplus is not less than setting value.
Short:reagent surplus is less than setting value.
Without:reagent surplus is 0.

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14.3 Reaction disk status


Click Reaction Disk to enter into reaction disk status interface.

Click the reaction cuvette position which you want to check from reaction disk
monitor chart,then relevant message will be showed on the right browsing area.

Reaction status:we use different colours to show different status of reaction disk.

Free:reaction cuvette is not used for current test.


Finish adding reagent 1:reaction cuvette has been added with reagent 1.
Finish adding reagent 2:reaction cuvette has been added with reagent 2.
Finish:have gotten the test result of sample in this cuvette.
Dilute:this reaction cuvette is used to dilute the sample.
Dirty cuvette:the difference between tested cuvette and blank value of
standard cuvette exceeds 1000.

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15 Alarm of instrument and solutions

15.1 Confirmation of alarm information

When instrument alarms,an alarm icon will appear on the upper left of main
interface. Enter into alarm message interface,you could check the alarm
message,when quit from alarm informationinterface,the alarm icon will disappear.

Click alarm information button under main interface,enter into interface


of Alarm information,as shown below:

a This list shows all the alarm message for the day,if you want to check the
previous alarm message,please choose a start date and an ending
date,then clickQuery button.
b If you want to check a detailed description and solutions for one alarm
message,please only click this piece of alarm message from list.
c If you want to delete an alarm message,please firstly choose this alarm
message from list,then click Delete button.

15.2 Type of alarm information

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According to different alarm information content,the alarm information can be


divided into data alarm and failure alarm.The data alrms are all attention level
alarm;the failure alarms contains three different levels which are:attention,sample
probe suspend,stop.When happened different types of alarm message,the
instruments action will like below:

Alarm information
Instruments action
type

The alarm(Attention level) which sees test result as object,the


Data alarm
instrument will go on testing.
It will appear on both data alarm and failure alarm.The test
Attention level
will go on,the operator can decide whether go on or stop
alarm
testing according to detailed situation.
Sample probe The object to this alarm is instrument fault,the sample probe
suspend level will stop adding new sample,the samples which are already
alarm added to reaction cuvettes will go on testing.
The object to this alarm is instrument fault.The instrument will
Stop level alarm stop all movement immediately,the test results will be not
reliable.

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15.3 Content of alarm information and solutions

Alarm Alarm Alarm information Alarm information detailed


Solutions to alarm information
code level brief description description
(1)Check if the communication cables
Communication Send commands to host but connection is right.
0-0 stop
exception receive no response. (2)Restart software of instrument,connect
computer for on-line operation.
(1)Make the debugging operation on the
movement debugging interface.
Reaction tray unit
0-1 stop Reset sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Reaction tray unit
0-2 Stop Moving sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Mixing unit Anticlockwise limit sensor is not
1-1 stop (2)Once the instrument is not back to normal or
exception detected.
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Mixing unit
2-1 stop Upper limit sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.

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(1)Make the debugging operation on the


movement debugging interface.
Washing unit
3-1 stop (2)Once the instrument is not back to normal or
exception Upper limit sensor is not detected.
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Reagent tray unit
4-1 stop Reset sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Reagent tray unit
4-2 stop Moving sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Sample unit Anticlockwise limit sensor is not
5-1 stop (2)Once the instrument is not back to normal or
exception detected.
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Sample unit Clockwise limit sensor is not
5-2 stop (2)Once the instrument is not back to normal or
exception detected.
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Sample unit Timeout on waiting mixing bar
5-3 stop (2)Once the instrument is not back to normal or
exception reset.
appear other fault,please contact with
maintenance staff.

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(1)Make the debugging operation on the


movement debugging interface.
Sample unit
6-1 stop Upper limit sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Meet obstacle on vertical
6-2 stop Sample unit (2)Once the instrument is not back to normal or
movement.
exception appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Pipette unit
7-1 stop Upper limit sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Check if input the correct item parameter.
Pipette unit (2)Once the instrument is not back to normal or
7-2 stop Aspirating volume exceeded.
exception appear other fault,please contact with
maintenance staff.
(1)Check if input the correct item parameter.
Pipette unit (2)Once the instrument is not back to normal or
7-3 stop Spiting volume exceeded.
exception appear other fault,please contact with
maintenance staff.
(1)Make the debugging operation on the
movement debugging interface.
Data acquisition
8-1 Attention Timeout on reading baseline. (2)Once the instrument is not back to normal or
unit exception
appear other fault,please contact with
maintenance staff.

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(1)Make the debugging operation on the


movement debugging interface.
Data acquisition
8-2 Attention Timeout on reading test result. (2)Once the instrument is not back to normal or
unit exception
appear other fault,please contact with
maintenance staff.
(1)Restart the machine.
(2)Check if the float and waster pump could
Temperature
Float switchs off not detected in 5 work normally.
9-2 Attention control unit
seconds (3) Once the instrument is not back to normal or
exception
appear other fault,please contact with
maintenance staff.
(1)Restart the machine.
Temperature (2)Change ambient temperature.
9-3 Attention control unit Ambient temperature > 40. (3) Once the instrument is not back to normal or
exception appear other fault,please contact with
maintenance staff.
(1)Check if the heat belt and temperature
Temperature Reaction trays temperature< sensor could work normally.
9-4 Attention control unit Ambient temperature of inside (2) Once the instrument is not back to normal or
exception Instrument -7. appear other fault,please contact with
maintenance staff.
(1)Check if the heat belt and temperature
sensor could work normally.
Temperature
9-5 Attention Reaction tays temperature > 50. (2) Once the instrument is not back to normal or
control unit
appear other fault,please contact with
exception
maintenance staff.
(1)Check if the heat belt and temperature
Temperature Reaction trays temperature< sensor could work normally.
9-6 Attention control unit Ambient temperature of inside (2) Once the instrument is not back to normal or
exception Instrument +3. appear other fault,please contact with
maintenance staff.

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Waste container is The float switch in the waste


9-7 Attention (1)Please exhause the waste liquid in time.
full container floats.

Washing solution The float switch in the washing


9-8 (1)Please add washing solution in time.
Attention container is empty solution container falls.

The float switch in the distilled


9-9 Attention container is empty (1)Please add distilled water in time.
water container falls.

(1)Please check if the upgrade file is corrupt.


10-1 Stop FLASH upgrade Visit FLASH error.
(2)Try to restart the upgrade operation
unit exception
FLASH upgrade Length of receiving FLASH data (1)Please check if the upgrade file is corrupt.
10-2 Stop
unit exception error. (2)Try to restart the upgrade operation
EPCS
(1)Please check if the upgrade file is corrupt.
11-1 Stop EPCS upgrade unit
Visit EPCS error. (2)Try to restart the upgrade operation
exception
EPCS upgrade unit Length of receiving EPCS data (1)Please check if the upgrade file is corrupt.
11-2 Stop
exception error. (2)Try to restart the upgrade operation

EPCS upgrade unit Write EPCS data address error. (1)Please check if the upgrade file is corrupt.
11-3 Stop
exception (2)Try to restart the upgrade operation
(1)Check if the using and placement of reagent
is correct.
20-1 Attention Absorbance The absorbance exceeded 3.0. (2)Check if there is impurity in sample.
exceeded (3)Check if there is scratch on the cuvette.
(4)Check if the water is pure.

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(1)Check if there is impurity in sample.


Linearity checking On Kinetics method A,the linearity
20-2 Attention (2)Check if there is impurity in reagent.
limit exceeded exceed setting value.
(3)Please test after diluting sample.
(1)Check if the using and placement of reagent
On Kinetics method or two point is correct.
Absorbance limit
20-3 Attention kinetics method,the absorbance (2)Check if the absorbance limit setting is
exceeded
exceed setting value. correct.
3)Please test after diluting sample.
Linear range Test results exceeded setting (1)Check the linear range setting value.
20-4 Attention
exceeded value. (2)Please test after diluting sample.
(1)Check if the position of calibration solution is
The difference between
correct.
Drift rate checking approximately calculated
20-5 Attention (2)Check if input the correct concentration of
exceeded absorbance and tested
calibration solution.
absorbance exceed setting value.
(3)Recalibrate.
The absorbance difference for (1)Check if the setting value is correct.
Discreteness
20-6 Attention each standard liquid testing 2 (2)Check if the cuvette is clean.
checking exceeded
times exceed setting value. (3)Check if exists cross contamination.
The difference between
absorbance of standard liquid
(1)Check if the setting value is correct.
1(the average value for 2 times
(2)Check if input the correct concentration of
Sensitivity tested)and absorbance of the
20-7 Attention calibration solution.
checking exceeded highest concentration standard
(3)Check if the calibration solution lose efficacy.
liquid(the average value for 2
(4) Check if the reagent lose efficacy.
times tested) is less than setting
value.
The twice tested average value (1)Check if the setting value is correct.
Blank level
20-8 Attention for absorbance of standard liquid (2)Check if the reagent lose efficacy.
checking exceeded
1 exceeded setting value.

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Sample volume is (1)Check if the sample volume is enough.


30-1 Attention Sample volume is not enough.
not enough (2)Check if the sample position is correct.

Reagent volume is (1)Check if the reagent volume is enough.


30-2 Attention Reagent volume is not enough.
not enough (2)Check if the reagent position is correct.

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16 Instrument Maintenance

In order to guarantee the reliability, good working order and life span, please
strictly follow the instructions to operate the system and maintain it regularly.

As for the unsolved problems and unmentioned maintenance problems in use,


please contact with the service department of Sunostik or the local distributor in
time.

Warning:

Please don't do any maintenance that hasnt mentioned in this chapter. Or it


may cause the system damage and personal injury. If unauthorized
maintenance are carried out, it may cause the system damage and personal
injury, and also the promised clauses in the maintenance contract won t be
valid any more.
After the maintenance work, please make sure the system can work normally.
For safety, all the maintenance work are carried out with closing the power of
analyzing department and refrigeration department. Please dont spill water,
reagent and any liquid on the mechanical or electric parts.

Biological pollution hazard


During the maintenance processing, please be sure to wear gloves, work
clothes to protect from infection, and wear safety goggles in a pinch.

16.1 Preparation for the maintenance


During the maintenance processing, the followed tools and cleaning agent
may be needed.
(1) Tools:
M3M5 inner hexagon spanner
Shape and screwdriver (large, middle, small)
Pincet
Clean gauze
Clean brush
Clean Q-tip

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(2)Intensified cleaning agent:


Acidic intensified cleaning agent: 0.1mol/l hydrochloric acid

Alkalic intensified cleaning agent: 0.5(V/V) sodium hypochlorite

Attention:
Dont mix the acidic intensified cleaning agent and the alkalic intensified
cleaning agent.
Please use the appointed cleaning agent by Sunostik. If use other cleaning
agent, the veracity of the test results may be effected.

(3)Others
Ethanol
Disinfector

16.2 Daily Maintenance

16.2.1 Checking the Distilled water tank

Attention:
The distilled water should meet the requirements of Type
GB6682 .Other detail requirements, please see appendix C

Check as the follow steps

dMake sure the power supply of analysis unit is off or in stop stage;
eCheck how much distilled water is left in the tank, if not enough to
proceed to the next step, then the test is finish.
f Unscrew (counter clockwise) the tank cap and remove the cap
together with the pickup tube and the sensor .After removing the
tank cap (together with the pickup tube and the sensor), place it on
a clean table.
gAdd the distilled water into the tank
hScrew (clockwise) the cap together with the pickup tube and the
sensor back onto the tank until secure.

16.2.2 Checking the Waste liquid tank

Biological pollution hazard


Ware gloves and lab coat and if necessary, goggles .Disposals of
waste water in accordance with your local or national guidelines for

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biohazard waste disposal, and consult the manufacturer or


distributor of the reagents for detailed.
Check as the follow steps

1 Check how much volume is left in the waste tank .if it necessary to be
emptied, proceed to the next step.

2 Unscrew (counter-clockwise)the cap of the tank together with the waste


tube and the sensor from the tank. After removing the cap together with
the waste tube and the sensor , place it on a clean table.
3 Empty the tank
4 Screw(clockwise)the cap(together with the waste tube and the sensor)
back onto the tank until secure.

Attention:

When placing the waste tank, ensure the top of the tank is lower than
the bottom of the upper cabinet .Ensure the waste tube is over the tank
and not blocked, bent or twisted. A blocked, bent or twisted waste tube
may lead to wastewater overflow that may damage the analyzer.

16.2.3 Checking the Probe

1 Check whether the probe is bent or dirty.


If bent, contact Sunostik Service Department of the local distributor.
If dirty, clean the surface with alcohol- extracting dishcloth.
2 During washing process, check the flow from the interior of the probe is
continuous and in the direction of the probe to the waste tank and have no
overflow. If so, there must be a block in the interior of the probe, clean it
Reference to 16.3.1.If not , check the connected tube and whether the
tank is full of waste water .
3 check the position that the probe past, such as the position of reagent1,
reagent2, the position of washing pull, and the position of reaction. During
getting down process, it should be in the middle of the reagent bottle,
washing pull and reaction cup so that it will not reach obstacle.
As for detail operation, according to the operation under the window
called "equipment debugging" of " system setup".
If there is a big deviation of one of above position, please get into
debugging window to debug.
4 Check the movement of probe to see whether the movement is smooth
and if there is a big noise. To prevent the influence of stain on the
kinematic axis of the probe arm, please use clean rag to wipe the
kinematic axis of probe arm at any time.
16.2.4 Checking the Mixing Probe

1 Check whether the mixing probe is bent or dirty.


If dirty, use acid or alkaline detergent-soaked clean rag and gently dean the

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exterior of probe.
If bent, please contact Sunostik Service Department or Your local distributor.
2 When mixing, check whether the water ran over the tube of washing pool to
the waste tank. If so, check the connection between the tube and tank, or
check if the tank is full or not.
3 Check the position that the probe pass, such as the position of mixing tank
and the position for mixing. It should be in the middle of the above position
during getting down process. washing pull and reaction cup so that it will not
reach obstacle. If there is a big deviation of one of above position, please get
into debugging window to debug.
4 Check the movement of probe to see whether the movement is smooth and if
there is a big noise. To prevent the influence of stain on the kinematic axis of
the probe arm, please use clean rag to wipe the kinematic axis of probe arm
at any time.
16.2.5 Checking the Washing system

1 Check whether the cleaning probe is bent or dirty.


If the exterior of the mixing probe is dirty, use acid or alkaline
detergent-soaked clean rag and gently dean the exterior of probe.
If bent, please contact Sunostik Service Department or your local distributor.
2 Turn off power, and move the cleaning probe to the position where the
cleaning probe can get into the cuvette. Check if there is any prangs .If one of
the probe cannot get into the cuvette because of the deviation of the position.
If so, please contact Sunostik Service Department or your local distributor.
3 During the cleaning process, check if there is much distilled water on the
bottom of the cuvette. If so, please contact Sunostik Service Department or
your local distributor.
4 Check if the tube which is connected with cleaning probe is damaged or not, If
so, please contact Sunostik Service Department or your local distributor.
5 Check if there is distilled water running over the cuvette during the cleaning
process. If so, please contact Sunostik Service Department or your local
distributor.

16.3 Weekly Maintenance

16.3.1 Cleaning the sample probe

CAUTION
The probe tip is sharp and can cause puncture wounds. To prevent
injury, exercise caution when working around the probe.

Biological pollution hazard:


Wear gloves and lab coat and, if necessary, goggles.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.

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The detail operation is as follows:

1 Place the power to OFF.


2 Remove the cover from the sample/reagent disk.
3 Remove the sample/reagent disk
4 Pull the probe arm to the highest point by hand. Rotate the probe arm to
move the probe to a position above the sample/reagent compartment
and convenient to operate.
5 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently
clean the exterior of the probe until it is clean and smooth
6 After cleaning, gently pull the probe arm to its highest point and rotate
the probe arm to move th probe to a position above the wash well.
7 Load the sample/ reagent disk.
8 Close the cover.

16.3.2 Cleaning the mixing probe

WARING
To operate carefully to avoid causing the mixing probe out of shape.

Biological pollution hazard


Wear gloves and lab coat and, if necessary, goggles.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.

The detail operation is as follows:


1 Place the Power to OFF.
2 Pull the mixing probe arm to the highest point by hand. Rotate the probe
arm to move the probe to a position convenient to operate.
3 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently
dean the exterior of the mixing probe until it is clean and smooth.
4 After cleaning, gently pull the probe arm to its highest point and rotate the
probe arm to move the probe to a position above the wash well.

16.3.3 Checking the injecting probe

Warning:

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To operate carefully to avoid causing the mixing probe out of shape and
injury.

Biological pollution hazard


Wear gloves and lab coat and, if necessary, goggles.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.

The detail operation is as follows:

1 Place the Power to OFF.


2 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently
dean the exterior of the mixing probe until it is clean and smooth .Do not
use excessive force when cleaning the probe. Otherwise it may bend.
3 If there is grime on the principle axis of the cleaning probe, please pinch
gauze and gently dean the surface of the cleaning probe until it is clean,
and smooth. Do not use excessive force when cleaning the probe.
Otherwise it may bend.
4 If the quantity of water in one cuvette is much different from the others,
use acupuncture pin to go through relevant water input probe (the short
one is water input probe).

16.3.4 Cleaning the reagent / sample compartment

Warning:
Take care and prevent the sample and reagent in sample/ reagent
compartment spilled out. If necessary, put separately of all reagent and
sample which are taken off from sample/ reagent compartment.

Biological pollution hazard


Wear gloves and lab coat and, if necessary, goggles. Dispose of the
used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

The detail operation is as follows:

1 Place the Power to OFF.


2 Press reagent/sample disk with hands to prevent its moving. At the
same time rotate the button on reagent/sample compartment
anticlockwise.
3 Take out reagent/sample disk and put it on clean table.
4 Use clean gauze (water or disinfector-dipped gauze if necessary to
clean the inside of the compartment.
5 Load the sample/reagent disk.
6 Close the cover.

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16.3.5 Cleaning the waste liquid tank

Biological pollution hazard


Wear gloves and lab coat and, if necessary, goggles. Dispose of the
used gauze in accordance with your local or national guidelines for
biohazard waste disposal.

The detail operation is as follows:

1 Place the Power to OFF.


2 Unscrew counter-clockwise) the cap (together with the waste tube
sensor and the leader). Put them on a clean table.
3 Empty the waste tank.
4 Wash the tank interior with clean water. Soak the tank with disinfector if
necessary.
5 Wipe water off the tank exterior, waste tube and sensor cable with clean
gauze .Use detergent to clean the stain on the sensor, if necessary.
6 Screw waste senor and its leader back onto the tank. Waste tube should
not be bent.
16.3.6 Cleaning the distilled water tank compartment

The detail operation is as follows:

1 Place the Power to OFF.


2 Unscrew (counter-clockwise) the cap (together with the distilled water
pickup tube and the sensor), and put them on a clean table.
3 Empty distilled water tank.
4 Wash the tank interior with clean water, if necessary, use disinfector.
5 Wipe water off the tank exterior, pickup tube and sensor cable with clean
gauze. If necessary, clean the stain of the sensor with detergent
6 Screw senor and its leader back onto the tank. Waste tube should not be
bent.
16.3.7 Cleaning the panel of the analyzer

Warning:
The probe tip is sharp and cause puncture wounds. To prevent injury,
exercise caution when working around the probe.

Biological pollution hazard


Wear gloves and lab coat and, if necessary, goggles.
Dispose of the used gauze in accordance with your local or national

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guidelines for biohazard waste disposal.

The detail operation is as follows:


d Place the Power to OFF.
e Pinch alcohol-soaked gauze and gently dean the exterior of the panel
of analyzing unit, if necessary, use disinfector-soaked gauze.

16.4 Monthly Maintenance.

16.4.1 Cleaning the wash well of the Probe

Warning
The probe tip is sharp and can cause puncture wounds. To prevent injury,
exercise caution when working around the probe.

Biological pollution hazard


Wear gloves and lab coat and, if necessary, goggles. Dispose of used cotton
swabs in accordance with your local or national guidelines for biohazard
waste disposal.

The detail operation is as follows:

1 Place the Power to OFF.


2 Pull the probe arm to its highest point. Rotate the arm to move the
probe away from the wash well.
3 Clean the inside of the wash well and the place around the wash well
with cotton swabs.
4 Pull the probe arm to its highest point and rotate it to move the probe to
a position above the wash well.

16.4.2 Cleaning the wash well of the mixing probe

Warning:
Please operate with caution to avoid hurting by the probe tip.

Biological pollution hazard


Please wear gloves and work clothes to prevent infection when operating, if
necessary , please wear the protective goggles.

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The operation in details:

1. Place the main power to OFF.


2. Pull the rocker of the Mixing probe to the highest place, then turn it, and make
the Mixing probe far away from the washing well.
3. Clean the inside and outside parts of the Mixing probe washing well with
cotton swabs that dipped with alcohol until it is clean enough.
4. Turn the Mixing probe rocker to the above of the washing well.

16.5 Maintenance every six months


Cleaning dust screens
1. Place the main power to OFF.
2. Clean the surface of the dust screen with cotton swabs that dipped with
alcohol until it is clean enough.

16.6 Irregular Maintenance

16.6.1 Cleaning the Sample Probe

When the probe can't pipette or the water flow is abnormal when washing, then
the probe may be clogged. We need to unplug the probe.
The clearing of the probe should follow the following steps: removing the probe,
cleaning the probe and fixing the probe.
16.6.1.1 Dismantle the Probe

Warning:
Please operate with caution to avoid hurting by the probe tip.

Biological pollution hazard


Please wear gloves and work clothes to prevent infection when operating, if
necessary, please wear the protective goggles.
The gauze used for cleaning shouldn't be discarded arbitrarily, please
dispose them according to the relevant rule.

The operation in details:

1. Place the main power to OFF.

2 Little hard to Button up the edge of Probe case bottom, separate from the
buckle of the base ,take of the Probe arm as the picture 16.6.1.1 shown
below:

3 Pull out the pipette on the ektexine of the Probe, then take off the pin
connector on the liquid detection board .

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Picture 16.6.1.1Sketch map of probe arm

4 Release 2 inner hexagon screws onTumbler Stationary Bushing, take of


probe arm,screw off the "locknut" and snap spring clip of probe fixing
component.Take off the probe components. Do not lose the spring in the pass.
Snap spring position as below16.6.1.2:

Picture 16.6.1.2 Sketch map of snap spring for probe fixing


5 Sketch map of Probe components dismount 16.1.6.3

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Picture 16.6.1.3 Sketch map of dismantle probe components

16.6.1.2 Sample probe cleaning

Warning:
Please operate with caution to avoid hurting by the probe tip.

Biological pollution hazard


Please wear gloves and work clothes to prevent infection when operating,
if necessary, please wear the protective goggles.

The operation in details:


1.Unplug the Probe with an acupuncture needle.
2. Clean the surface of the probe with gauze that dipped with alcohol.
3. Dont fix the probe at first. Cover the needle tube with the pipette, and find
the option of Instrument Adjusting in the interface of System Setting.
Then find the option of Probe Washing, input the washing time. Then
press the button of Test and check the water flow of the probe.

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Warning:
When testing the probe, before pressing the button of Test, you
shouldnt make the probe face the machine. So as to avoid the liquid
splashing on the machine.

4. If the water flow of the probe is continuous, then the washing is successful.
Then you could fix the probe.

16.6.1.3 sample probe fixing

Warning:
Please operate with caution to avoid hurting by the probe tip.

Biological pollution hazard


Please wear gloves and work clothes to prevent infection when operating,
if necessary, please wear the protective goggles. The gauze used for
cleaning shouldn't be discarded arbitrarily, please dispose them according
to the relevant rule.

The operation in details:


1. Place the main power of the analyzing part to OFF.
2. Put the new probe components with spring into fixing hole from the top of
probe arm.Put the "Fastening button" through probe tube and fix it good,
then fix the "snap spring"
3. Hold the probe tip and move up vertically, then release and check if the
probe back to the original position smoothly. If no, please repeat the actions
above to install again.
4. Fix the "Tumbler stationary bushing" onto probe arm and fasten.
5. Adjust the probe is under the interface of "Action adjustment". Choose
"reaction position", click "Yes" button. Place the probe tip to the centric
position of cuvette by hand, then fasten 2 screws on the "Tumbler stationary
bushing". Then make the probe reset and take a look the position of probe
tip. If it's not on the centric position, release the screws and retest until meet
the demands.
6. Match the 4 pimplings on the probe case to the 4 holes on beside of probe
base, the press the probe case hardly. The probe fixing finished when you
heard "ka".

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16.6.1.4 Sample Probe replacement

Warning:
Please operate with caution to avoid hurting by the probe tip.

Biological pollution hazard


Please wear gloves and work clothes to prevent infection when operating, if
necessary, please wear the protective goggles. The gauze used for cleaning
shouldn't be discarded arbitrarily, please dispose them according to the
relevant rule.

The operation in details:


1. Place the main power of the analyzing part to OFF.
2. Withhold the downside edge of the sample probe cover and make it out of t he
fastening button, meanwhile forward your stenghth upwards, you will take off
the cover
3. Dismantle the sample probe componets as the following sketch map 16.6.1.4
shows.
4. Repalce with the new sample probe components
5. Adjust the probe is under the interface of "Action adjustment".

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Picture 16.6.1.4 Sketch map of probe components

6. Exploded view of sample probe arm as 16.6.1.5:

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Picture16.6.1.5 Exploded view of probe arm

16.6.2 Mixing probe replacement

Warning:
Please operate with caution to avoid hurting by the probe tip.

Biological pollution hazard


Please wear gloves and work clothes to prevent infection when operating, if
necessary,
please wear the protective goggles. The gauze used for cleaning shouldn't be
discarded arbitrarily, please dispose them according to the relevant rule.

The operation in details:


1. Place the main power of the analyzing part to OFF, turn the mixing
probe to the place that easy for replacing.
2. Unscrew the screws that used for tightening the Mixing probe. The Mixing
probe will be comes off at the same time.
3. Refert to the picture 16.6.2.2 replace the new Mixing probe deviceMixing
probe and fixed column.
4. Use the upper computer software to control the Mixing probe position and

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height during mixing.


5. Sketch map of Mixing device

Picture 16.6.2.1 Sketch map of Mixing device

6. Sketch map of Mixing probe disassembly:

16.6.2.2 Sketch map of Mixing probe disassembly

7. Adjust all parts of the Mixing probe position on "Action Adjustment"


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interface.

16.6.3 Replacing the Lightsource lamp

High-temperature Warning:
Before replacing the Light source lamp, you must turn off the power of the
Analyzing part for 20 minutes. Or else, the high temperature of the lamp may
burn your hands!

The operation in details:


1. Turn off the power of the Analyzing part for 20 minutes, then begin to replace.
2. Unload the 6-connected cuvettes in the Calorimetric disc, then put them on a
clean place.Please refer to the following picture:

Picture 16.6.3.1 Sketch map of dismantle the cuvettes

3. Unscrew the 4 screws that used for fixing the Colorimetric disc, then take

offPlease pay attention to avoid bumping the washing system.

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Picture 16.6.3.2 Sketch map of dismantle the cuvettes holder

4. Find out the light source bracket.

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Picture 16.6.3.3 the light source bracket

5 .Unload the light source bracket


Unload the Lamp Shelf with the Hexagon wrench of size 4refer to the
picture below:

Picture 16.6.3.4 light source bracket

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6. Unload the light source

Picture 16.6.3.5 Sketch map of dismantle the light source

Warning

During changing the lightsource lamp, please do not touch the new lightsource
lamp surface, in order to avoid dirtying the surface of the lightsource lamp. You
can wrap the light source with the clean lens paper during the replacement.

7. Lightsource lamp position adjustment


When fix the light source bracket to the position as the picture shown below, the
light source bracket should be close to the outboard(the side of colorimetric disc
axis)as possible.Please don't fasten two inner hexagon screws which are used for
fasten the light source lamp. The power switch should be turn on, check the
aperture projection position, should be uniform distribution around the center hole
of light path of lens shelf .Fasten the screws a little after adjusting the position of
light source bracket, Then use the software of upper computer for the final
adjustment.

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Picture 16.6.3.6 Sketch map of the lightsource lamp position adjustment

8. Examine A/D value after adjustment


Under "action adjustment" interface, choose wavelength "340nm" in the
drop-down list,click OK, A/D value will be displayed,write down the A/D value.
Then move light source bracket little, click OK, check the A/D value againrepeat
the operation,find out the biggest A/D value. Then fasten 2 inner hexagon screws
of light source bracket. Then check again if the A/D value of the other wavelength
are within A/D conversion range (A/D range 5000-30000).

Picture 16.6.3.7 Check A/D Value

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Appendix A System specifications

A.1 Machine performance


Machine type: Optional discrete
Throughput: constant 200 tests/h , 280T/H at mostoptional ISE
Testing method:
Endpoint Method, Fixed time Method(Two-point Mothod ), Kinetic Method
(Velocity Method), Immunoturbidimetry.
Single-wavelength / Double-wavelength / Multi-wavelength Testing Method
Single / Double Reagent, Single / Double wavelength Testing
Test setting: Single term testing, Multiterm testing, Group item testing, Batch
testing
Testing item: Routine Biochemistry, Specific protein, Electrolyte, Therapeutic
medicine, Urine, Myelencephalon, etc.
Item testing: Completely open for editing testing items, freely edit assemble and
setting to avoid the mutual interference items.

A.2 Sample system


Sample tray: 44 sample position in total, the whole sample tray can be replaced
together and every position can be an emergency position, and the emergency
position can be inserted at anytime during the routine testing.
Sample tube specification: minim sample cup, vacuum test tube, plastic test
tube.
Sample volume: 3ul-100ul1ul stepping
Sample probe: Multifunctional integrated sampling probe, which has automatic
liquid level detecting function and automatic inside and outside washing
function.
Sample probe washing: Automatic completely wash inside and outside with
warm water, the contamination rate is less than 1%.
Sample processing: Automatic pre-dilution, automatic dilution and automatic
retest.
Sample syringe: America-imported syringe, long-life and high-precision ceramic
piston. High-precision when loading sample, hard wearing, low cost for
maintenance.
Other optional function: Probe code scanning.

A.3 Reagent system


Reagent tray: 44 reagent positions, single and double reagent optional, reagent
position can be set freely, the whole reagent tray can be replaced together.
Reagent refrigeration: Continuous refrigeration for 24 hours in 415; Peltier
refrigeration; Independent power for refrigeration.
Reagent bottle: 25ml40ml; slope-bottom designed.
Reagent volume: 150ul300ul; Progressive increase by 1ul; Reagent blank
can be omitted automaticall when testing.

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Reagent probe: Multifunctional integrated reagent probe, which has automatic


liquid level detecting function and vertical anti-collision function,
and can automatically wash inside and outside.
Reagent probe washing: Automatic completely wash inside and outside with
warm water, the contamination rate is less than 1%.
Sample syringe: America-imported syringe, long-life and high-precision ceramic
piston. High-precision when loading sample, hard wearing, low cost for
maintenance.
Other optional function: Probe code scanning.

A.4 Reaction system


Reaction tray: 48 reaction cups; 6 mm optical path; hard plastic cuvette; high
penetrability of the ultraviolet radiation(UV); acid resistant; corrosion-resistant;
semi-permanent use; low consumption; low cost.
Reaction mode: Post-spectrophotometry testing.
Volume of the reaction solution: 200ul300ul
Reaction time: 10 minutes or so.
Reaction temperature: 37; Temperature precision: 0.1
Constant temperature of Reaction tray: Directly heat the solid, no need for daily
maintenance
Mixing system: Independent mixing probe. For single reagent, mixing after
adding the reagent and sample; for double reagent, mixing after adding the
second reagent.
Reaction cup washing: 8-step automatically washing , no need for manual
intervention. Adopting the technique of pumping out, deproteinized by adding
washing liquid, then washing and drying, so as to avoid cross contamination.
Water consumption: 5L/h or so.
Reaction cup washing liquid: Has the function of Warning for low liquid level of
washing liquid and distilled water.
Waste liquid processing: Has the function of Warning for high liquid level of the
waste liquid bucket.

A.5 Optical system


Light source: Halogen lamp6V/10Wlife span2000hours.
Wavelength: 10 high quality interference filters: 340nm405nm450nm
492nm505nm546nm578nm620nm670nm700nm
Band width: 8nm
Detector: Photoelectron Diode Array
Absorbance range: 0.0003.000ABS
Resolution0.001ABS
Stray light0.5%

A.6 Calibration and Quality control


Calibration mode: 9 mode: linearity (single point, double point and multi-point),
logit-log4p, logit-log5p, spline curve, exponential function, polynomial and
parabola.

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Calibration period: Set automatically or according to needs.


Quality control rule: Westgard, Cumulative Sum Check and Twin Polt. Allowing
quality control for three concentration.
Quality control mode: Real-time Quality control, daytime Quality control and
daily Quality control.

A.7 Operating system


Operation system: Windows 2000and above, fully Chinese operating system.
Data processing: Large capacity for testing results; show, save and print
reaction curve.
Report output: Edit and print complete Chinese report; content / format optional;
paper optional and editable; support network printing.
System interface: RS-232 Interface.

A.8 Working Enviroment


Power: 220V22V50HZ1HZ Power Consumption:400VA
Environmental temperature:1530 Humidity:85
Dimension: 760(L)560(W)1018(H) mmWeight: 105Kg

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Appendix B Accessories/Consumbles

To ensure personal safety and system performance, please use supplies


manufactured or recommended by Sunostik only. Contact After-sales Department
of Sunostik or local distributors if necessary.

Accessory Specification Location suggested replacing period

Light source lamp 6V/10W under the reaction tray > 2000 hours

Sample Probe assembly Sample Probe arm Replace it when it is


damaged

Mixing probe assembly Mixing probe arm Replace it when it is


damaged.

Cuvette 5mm6mm25mm reaction tray Replacing periodically or


when receive reminding
message

Cuvette shelf reacton tray Replace it when


It is damaged

Peristaltic pump Backpanel of instrument Replace it when


It is damaged

Fuse 6A/220V 520 Backpanel of instrument Replace it when


It is damaged

Washing mechanism assembly Washing mechanism Replace it when

it is damaged

Reagent bottle 40ml Reagent/Sample tray Consumable


Reagent bottle 25ml Reagent/Sample tray Consumable
Reagent bottle covers Reagent/Sample tray Consumable
Copy paper Printer Consumable
Washing solution Washing tank Consumable

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Appendix C Parameter list of China National Labs standard

of analyzing water GB6682-92

Name Class I Class II Class III

PH range25 - - 5.0-7.5

Conductivity25,mS/m 0.01 0.1 0.5

Specific resistanceM.cm.2510 1 0.2



Oxidizable substance[0]mg/L - 0.08 0.4

< Absorbance254nm,1cm optical 0.001 0.01 -


path
Residue on evaporation - 1 2
1052mg/L
Tolerance silicon [sio2]mg/L< 0.01 0.02 -

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Appendix D Barcode reader instruction

D.1 Probe code reader using range


This equipment can fix the probe code reader optional, inside and outside
reagent and sample can use one probe coder reader for scan operation.
D.2 Probe code using requirement.
D.2.1 Probe code typeCode 128(10 digits)
D.2.2 Probe code lable size

3021100000

Picture D.2.2 Lable size

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Picture D.2.2.1 Sketch map of sticking lable

D.2.3 Picture of label on the reagent bottle

Picture D.2.3.1 Picture of label on the reagent bottle

D.2.4 Picture of lable on the sample tube

Picture D.2.4 Picture of label on the sample tube

D.3 Probe code nomenclature principle


D.3.1 Probe code nomenclature principle for reagent bottle
Reagent bottle probe code No. is 10 digitsNo1. Stand for reagent position on the
sample diskInner ring and out ring reagent.1 stand for inner ring 2 stand for out
ringNo.2-4 stand for reagent No.Example 001 stand for GPT reagent. No.5
stand for reagent, 1 stand for reagent 1, 2 stand for reagent 2. No.6-8 stand for
reagent validity.No.9-10 stand for manufacturer code.
D.3.2 Probe code nomenclature principle for sample tube
Sample tube probe code No. is 10 digits. No1 digit is fixed position 3, stand for
sample tube is located the out ring of reagent/sample disk. NO2-4 stand for test
patient sample No.. No.5 stand for test sample type. (1 stand for patient sample
2 stand for calibration liquid3 stand for control plusNo.6-8 stand for validity of
control plus and calibration liquid. No.9-10 stand for reserved position code.

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D.4 Reagent or/sample tube model instruction


D.4.1 Reagent bottle model:
Use our comany's reagent bottle, 40ml and 25ml standard
D.4.1.1 Sample tube using help
Glass tube/plastic tube1268.5129912.77512.7100

D.5 Sketch map of Reagent bottle/sample tube with probe code on the
reagent/sample shelf position:
D.5.1 Sketch map of reagent bottle position.

Picture D.5.1 Sketch map of Reagent bottle with probe code on the
reagent/sample shelf position
D.5.2 Sketch map of ample tube position

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Picture D.5.2 Sketch map of sample tube with probe code on the
reagent/sample shelf position

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