ACCRE-6

Automatic Chemiluminescence Immunoassay

(CLIA) Analyzer

Service manual

Shenzhen Tisenc Medical Device Co., Ltd

PREFACE
The purpose of maintenance for the analyzer is to guarantee that the analyzer
can keep in good conditions to operate. Please follow the instruction
carefully for the maintenance procedure.

Product Name: ACCRE-6 Automatic Chemiluminescence Analyzer

Intend Use: The ACCRE6 system is an in vitro diagnostic device used for
the quantitative, semi-quantitative, or qualitative determination of various
analyte concentrations of various analyte found in human body fluids.

Warranty
Tisenc guarantees a warranty for the ACCRE-6 analyzer from the date of
delivery to the user. For this period it is guaranteed that the Analyzer works
within quality requirements valid on the date of manufacture release.
Tisenc is prepared to compensate for faulty material or malfunctions within
the limitations of the warranty. Tampering with the internal components,
damage due to operating errors, misuse and overlooking essential
information with respect to warnings and precautions described in this User
Manual will invalidate the warranty.
Products will be repaired with charge during the warranty period in
following cases;
1> Improper use or misuse
2> Consumer’s intentional abuse or neglect of the products
3> Unauthorized repair or parts replacement
4> Lots product warranty or changes in contents
5> Damages or defects due to fire, pollution, earthquake or other natural
disasters.
The acknowledgment of claims shall immediately be reported to your local
authorized representatives.
1. User’s Maintenance Procedure

1-1 Weekly Maintenance

1> Clean the Waste tip box
Waste box of tip is recommend to be clean once every 20 tests or every
weeks.
2> Clean the reagent rack
Clean the reagent rack with alcohol cotton several time.
3> Clean the table
Clean the table with alcohol cotton several time.
1-2 Monthly Maintenance
1> Clean the surface of analyzer gently by damp cloth.
a) DO NOT get any liquid or detergent into the analyzer during the
clean procedure.
b) Please note that alcohol can not be used cause the door of reagent
chamber is made by acrylic, and alcohol can damage the acrylic
door.
2> Clean the tip area
Clean the area where the tips are placed with alcohol cotton several time.
Please change the alcohol cotton for every tip position to reduce cross-
contamination.
3> Check the calibration date
If the calibration was expired, perform the calibration test to recalibrate
the assays.

2. Replace the Paper of Thermo-Printer

Please check if the printer frequently, and if the printer paper is out,
change the printer paper according to the following procedure:
Open the thermo printer cover on the right side of the analyzer, Fig 2-1
 Fig 2-1 Open the thermo printer cover

Remove the used printer paper reel, and install the new printer paper
reel into the printer, please note the direction of paper reel, as Fig 8-2, then
place the setting plate of the printer into its original position. Close the cover
of printer and cut the extra paper roll outside.

Fig 2-2 Install the printer paper

3.Specifications of fuse
The fuse is shown in the red box, as fig 3,
Specifications:fusing,250V.6A,5*20mm.
Check the fuse if it’s working normally.
 Fig 4 Fuse of the power seat

4.Performance check-Engineer’s maintenance

It is recommended to do periodical maintenance for the analyzer to ensure
the analyzer’s best operation condition, please contact the authorized
representative or technical service of Tisenc for the detail information.

4.1 Aging test

In order to ensure best testing condition, please contact the authorized
representative or technical service of Tisenc for aging test periodically.
Enter the service menu on the software with Tisenc account. Choose Aging
test menu and perform the Aging Test for 5 mins, Check if there was
problem, if yes ,need to fix it or adjust it .or contact with Tisenc Technical
Assistance.

4.2 RLU test

In order to ensure the PMT function, please contact the authorized
representative or technical service of Tisenc for RLU test periodically.
Enter the service menu on the software with Tisenc account .choose RLU
menu. Place 6 new reagent strips , select 6 channels and perform the RLU
test for 20 times. Each time ,RLU should be less than 400, greater than 0.
If there was problem, please contact with Tisenc Technical Assistance
4.3 TIP position check
In order to ensure the testing function, please contact the authorized
representative or technical service of Tisenc for TIP position test
periodically.
Enter the service menu on the software with Tisenc account .choose
Position settings menu.the tips should be in the proper position for the
NO.7 well on the reagent strips. The tips should not touch the bottom of the
No.7 well. And should be in the central of well. please contact with Tisenc
Technical Assistance for details

5. Trouble shooting
Listed below are all of the error messages programmed into the ACCRE
analyzer.
• If error messages other than the ones below appear, call Tisenc Technical
Assistance or your local representative.
• In some cases, there are suggestions for corrective action. Where no
corrective action impossible, or if the corrective actions fail, the final action
is to call Tisenc Technical Assistance or your local representative.
Se the table below :
 Error Error Analyzer’s
SN Error Description Resolution for Users
Level category Respond
Fail to access the assay
1
parameters
Fail to access the Internet
2
connection parameters
3 Fail to access the QC parameters
Documents Fail to access the Calibration
4
Error parameters
5 Fail to access the QC data Error Message
6 Fail to access the TEST data will display in
7 Fail to access the SYSTEM data software
Fail to access the Users Account screen, Restart the analyzer by
8
data analyzer will turn-off the power switch
9 Motion Error Error code 0-1000 pause on going and turn-on the power
10 Reading Initialization Error test if error switch again.If the error
11 Level 1 Error Reading Error happens, Use occurs again please
12 Syringe initialization Error should read the contact authorized
13 Pipette initialization Error error message representative or
PMT vertical position and Click”OK” technical service of
14
initialization Error to continue, Tisenc
PMT horizon position analyzer will
15
initialization Error restart after

Magnetic part initialization click “OK”

16 Other Errors
Error
17 Incubation initialization Error
Incubation Temperature Out of
18
Range
Pipettor Temperature Out of
19
Range
22 Fail to Save Data
Check if the barcode is
23 Fail to recognize Barcode
complete
Check if the barcode is
24 Not Abnormal Barcode
Level2 Notice provided by Tisenc
categorized
Check if the tip is
25 Fail to detect tips
correctly placed
26 Internet Connection Failed Check the connection of
 cable, then check if all the
parameters is correctly set
Not Check according to the
27 Level 3 Instruction for the Users Notice
categorized instruction
Note: Error level indicate the severity of errors ,Level 1 is the most sever error

6. Software update
In order to make sure the Software function work perfectly , it’s
recommended to update the software when there is new software.

Material: USB disk

Procedures:
1) prepare the USB disk(USB2.0,FAT32 form), and put the all upgrading
files to the root dictionary(no folders).

2) Shut down the instrument.

3) Connect the USB disk with the USB port on the back cover . please take
 off the barcode scanner first, only connect with USB disk.
4) Press and hold on the Rest button with an object(like the tips),and turn

on the machine , after hearing one beep sound, release the button,
then you will hear one more short beep sound , and one long beep sound,
after long beep sound , the machine will reboot, the updating is finished.
5) Check the software version by Search>> version, if not succeed, please
check the USB disk or the USB port, and repeat the steps again.