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Department: ITSD Version: V1 Date: 20230202

Annual Maintenance record form for MAGLUMI X3

Name of Contact Date of


End User Number Installation
Serial After-sales
Model
Number Specialist
Date of Date of last Confirmation of
Maintenance maintenance Regional Director
Summary of the instrument condition(test Number after last maintenance and record of major failure)

Inspection instructions:
1. If finishing one maintenance step successfully, check it on the option of FINISH OR NOT with√, otherwise
check it with×, and write down the reason as well as the solution.
2. Tool to clean components is dirt-free cotton, cotton stick or soft hair brush; tool to clean PCB boards is the
mini hair dryer; tool to clean the tube is syringe; tool to clean the clot is the special needle and syringe.
syringe used to clean the wash tube and waste tube cannot be mixed.
3. Using 75% of alcohol to clean all components and tube; using WD-40(Water Displacement, 40th formula)
to clean or remove rust of the axle and loader.

A. System Safety

The reason and


System safety Finish or not
solution for that
1. Test the ground condition of the office instrument with a
multimeter, and the voltage should be less than 3V.
2. Check the stability of power supply. The bias of voltage
input should be within 10% (Eg: the local voltage is 220V, the
bias should be within 22V).
UPS: □ Yes □ No

B. Check Software Version

Part Current version Latest version


Service Software
User Software
X3-01-E00 COP
X3-03-E00 Washer
X3-04-E00 Chamber
X3-05-E00 Multi-Module
X3-07-E00 Sample Arm
X3-0B-E00 Claw
Notice: Before updating the software, backup firstly.

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C. Check and Clean Part

The reason and


Check and Clean Part Finish or not
solution for that
1. Sample Arm
1.1 Wipe the outside of washing cup with dust-free cloth and 75%
ethanol. Then clean the inside of the cleaning cup and overflow
hole with swab and 75% ethanol.
1.2 Wipe the metal sheet and brass probe on pipettor with dust-
free cloth and 75% ethanol.
1.3 Wipe the outer surface of pipettor with dust-free cloth and 75%
ethanol. Inject 75% ethanol, or air to wash the inner wall after
disassembling the needle. Try not to use needle to clean the
inside for the inner wall might be damaged.
1.4 Clean the initialization sensor of sample arm’s X and Y axis
movement with swab.
2. Sample Reagent Area
2.1 Wipe the upper surface of sample reagent area with dust-free
cloth and 75% ethanol. Clean the lower part also by disassembling
it if necessary.
2.2 Wipe each slot of sample reagent area with dust-free cloth and
75% ethanol.
2.3 Wipe the sink of condensate water with swab or brush.
2.4 Wipe the barcode reader with dust-free cloth and 75% ethanol.
2.5 Clean the plastic dust caused by collision between the shaker,
shaker’s motor and eccentric wheel with swab.
3. Incubator
3.1 Wipe the top and entrance of each slots of incubator with dust-
free cloth and 75% ethanol.
4. Washer
4.1 Wipe the disk of washer with dust-free cloth and 75% ethanol.
4.2 Wipe the outer surface of washing needle, water proof metal
sheet with dust-free cloth, swab and 75% ethanol.
4.3 Wipe the outer surface of waste liquid needle with dust-free
cloth and 75% ethanol.
4.4 Wipe the washing hole of waste liquid needle with swab and
75% ethanol.
4.5 Wipe the inner and outer surface of vortexer with swab and
75% ethanol. Check if it can rotate smoothly.
4.6 Check if the inner wall of waste tube where the optocoupler
attaches is contaminated or not. Disassembly the tube and clean it
if necessary. Please execute Bubble Detection Optocoupler
Verification after disassembling. If calibration failed, please
consider checking the optocoupler and tubes. Changing them if
necessary.
4.7 Disassembly the washer disk. Clean the surface of magnetic

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and cuvette entrance detection sensor with swab and 75% ethanol.
4.8 Check the tubes, cables and fixing clip of washer. Confirm if
they are fixed well on the washer component. If they are loosen or
damaged, please adjust their position or replace them.
4.9 Check the peristaltic pump’s tube. Run pipeline test for 20 times.
The requirement of the result is CV<3% and the average result of
each needle is between 65-85. Adjust the tightness if out of range.
5. Chamber
5.1 Wipe the outer surface of waste liquid needle and signal
needle with dust-free cloth and 75% ethanol.
5.2 Wipe the nozzle with swab and 75% ethanol after opening the
cover of chamber.
5.3 Wipe the upper surface disk and working position with swab
and 75% ethanol.
5.4 Wipe the side and bottom of disk with dust-free cloth and 75%
ethanol.
5.5 Wipe the groove and cuvette detection sensor with dust-free
cloth, swab and 75% ethanol.
5.6 Confirm the torsion spring of light blocker. If the blocker can’t
be bounced, please try to solve it by rotating the needle. If it can’t
be solved, replace it.
5.7 Check the tubes of starters. Replace them if bend.
5.8 Check the cable of aspiration detection. Replace it if damaged.
5.9 Check the rotation of chamber disk. If it can’t rotate smoothly,
or its synchronize belt faces rapture or damaged by wearing,
please replace them.
6. Sample Disk
6.1 Wipe the sampling disk with dust-free cloth and 75% ethanol.
6.2 Wipe the outer surface and inner surface of vortexer with swab
and 75% ethanol by passing the holes on disk.
6.3 Disassembly the sampling disk, check if the bearing has some
fragment on it. Clean if necessary with dust-free cloth.
6.4 Disassembly the sampling disk and clean the initialization
sensor with swab.
6.5 Clean the cuvette detection sensor with swab.
7. Claw
7.1 Wipe the gripper with dust-free cloth and 75% ethanol.
Change the gripper if the shape is changed seriously. Adjust the
position in service software if the distance between the two clips is
too far. If adjustment can’t let the claw hold the cuvette, please
change the gripper.
7.2 Check the synchronous belt of claw. If the synchronize belt
faces rapture or damaged by wearing, replace them if damaged.
8. Cuvette Storage
8.1 Clean the dust on lifter, chip on the top and push rod with dust-

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free cloth and 75% ethanol. Adjust or replace the chip if its shape
is changed.
8.2 Clean the six sensors with swab and 75% ethanol as shown
below:
a) Initializing sensor for push rod (left side baffle is required to be
disassembled).
b) Cuvette box detection sensor at the entrance and exit.
c) Initialization sensor, bottom sensor and top sensor of lifter.
8.3 Clean the synchronous belt of new box transfer belt. Check
the condition of belt and replace or adjust the tightness if
necessary.
9. Cabinet
9.1 Wipe the baffle of analyzer, the door of sample reagent area,
the dust bin, the starter box holder and the inside of consumable
door with dust-free cloth and 75% ethanol.
9.2 Check the hinge of consumable door to see if its tightness is
suitable.
9.3 Check if the movement of dustbin is smoothly.
9.4 Check if the force required to open and close the cover of
instrument is suitable. Adjust the support force of the cover.
9.5 Take out the dust proof net and clean the dust with hair dryer.
Clean the dust on heatsink with brush.
9.6 Put the dustbin inside the instrument and wipe the channel for
cuvette discarding with dust - free cloth and 75% ethanol. Let the
dustbin collect the waste generated in this process.
10. Washing System Liquid Tank
10.1 Inject 80ml sodium hypochlorite (NaClO) solution with effective
chlorine content 5.5-6.5% and add pure water to 2L. Let the solution
soak all the inner walls of system liquid’s tank for 2-3min.
10.2 Wash the tank with pure water for at least 3-5 times after
soaking. Add system liquid back to the tank.
10.3 Wash the joints of system liquid tank.

D. Component Lubrication

The reason and


Component Lubrication Finish or not
solution for that
1. Sample Arm
1.1 Clean the grease on guide rails of X, Y and Z axis with WD40
and then wipe with dust-free cloth. Smear lubrication grease
Multemp PS No.2 or AS2 on the guide rails with dust-free cloth.
Please wipe the grease accumulate at the two ends after smearing.
2. Sample Reagent Area
2.1 Check whether the shaker’s rack, motor and eccentric wheel
rotate smoothly. If noise or resistance found, please lubricate with
grease Multemp PS NO.2 or AS2 and adjust the two brackets in the
left and right. Change the rack if lubrication can’t solve the problem.

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Shenzhen New Industries Biomedical Engineering Co., Ltd.

3. Washer
3.1 Clean the dust on the guide rail and slider of washer lifter with
dust-free cloth. Provide lubrication grease Multemp PS NO.2 or
AS2.
3.2 Clean the dust on washer mixers‘Z-axis with dust-free cloth.
Provide lubrication grease Multemp PS NO.2 or AS2.
3.3 Clean the dust on the guide rail and slider of washer mixers with
dust-free cloth. Provide lubrication grease Multemp PS NO.2 or
AS2.
3.4 Rotate the peristaltic pump manually and check each roller. If
resistance is vast, please clean the rollers with WD40 and add
grease for lubrication.
4. Chamber
Clean the dust on the guide rail and rack of chamber lifter with dust-
free cloth. Check if the rack can be driven smoothly. Provide
lubrication grease Multemp PS NO.2 or AS2.
5. Claw
5.1 Clean the dust on the screw of claw’s Z-axis with dust-free
cloth. Provide lubrication grease HSS17 and drive the claw
manually to smear the grease. Please wipe the grease
accumulate at the two ends after smearing.
5.2 Clean the dust on the guiderails of claw’s X and Y-axis with dust-
free cloth. Provide lubrication grease Multemp PS NO.2 or AS2 and
drive the claw manually to smear the grease. Please wipe the
grease accumulate at the two ends after smearing.
6. Cuvette Storage
6.1 Clean the dust on the guide rail of cuvette storage’s lifter with
dust-free cloth. Provide lubrication grease Multemp PS NO.2 or
AS2 and drive the lifter manually to smear the grease.
6.2 Clean the dust on the guide rail of push rod with dust-free cloth.
Provide lubrication grease Multemp PS NO.2 or AS2 and drive the
push rod manually to smear the grease.

E. Spare parts Replacement

The reason and


Spare parts Replacement Finish or not
solution for that
1.1 Tubes of peristaltic pump-change it during annual maintenance.
1.2 Pipetting needle-change every two years.
1.3 Inlet tubing of the sample arm-change during annual
maintenance.
1.4 Waste liquid pipes for sample arm’s washing cup-change during
annual maintenance.
1.5 Waste liquid pipes for washer’s waste liquid needles-change
during annual maintenance.
1.6 Waste needles of washer-change during annual maintenance.

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1.7 Inject needles of washer-change during annual maintenance.

F. Clearance of tubing

The reason and


Clearance of tubing Finish or not
solution for that
1.1 Check the inlet and outlet joints of starter pumps, clean crystal
accumulates if exist with 75% ethanol or pure water.
1.2 Clean the tubing between the waste liquid needle of chamber
and its waste pump by injecting 75% ethanol or air. Clean the inside
of waste liquid needle or replace it if blocked.
1.3 Clean the tubing between the chamber waste pump and thick
waste liquid outlet by injecting 75% ethanol.
1.4 Clean the tube between waste liquid needle in washer and
peristaltic pump by injecting 75% ethanol.
1.5 Observe the tube between peristaltic pump and thin waste liquid
outlet. Clean it or replace it if crystal found.
1.6 Clean the tubing between the cleaning holes of waste liquid
needles and its waste pump by injecting 75% ethanol. Replace it if
necessary.
1.7 Clean the tubing between the waste pump of washer and thin
waste liquid outlet by injecting 75% ethanol. Replace it if necessary.
1.8 Observe the tube of condensate water in sample reagent area.
Clean it or replace it if any blockade found.
1.9 Clean the tubing between the washing cup of pipette and waste
pump of sample arm by injecting 75% ethanol. Replace it if
necessary.
1.10 Observe the tube between waste pump of sample arm and
thick waste liquid outlet. Clean it or replace it if blockade found.

G. Alignment

The reason and


Alignment Finish or not
solution for that
1.1 Align the offset parameter of sample disk.
1.2 Align the offset parameter of washer disk.
1.3 Align the offset parameter of chamber disk.
1.4 Align the parameters of washer lifter including initial, wash hole
position etc.
1.5 Align the parameters of sample arm.
1.6 Align the parameters of claw.
1.7 Calibrate the voltage of PMT and measure the background. The
suggested PMT voltage parameter is between 160-200. The result of
background when LED turn off is between 1-80.Please find out the
reason if not meet the requirement.

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H. Liquid System Checking

The reason and


Liquid Path Checking Finish or not
solution for that
1.1 Prime chamber for 30 times and observe if liquid leakage found
at the joints on chamber waste pump and starter pump. At the same
time, please confirm the rotation of starter pump is normal. The pump
volume should be 195-205mg. If any abnormal found, please find out
the cause and fix it.
1.2 Prime washer for 30 times and observe if liquid leakage found at
the joints of peristaltic pump, waste pump of waste needle washing
cup, injection pump, wash pump of waste needle washing cup and
valves. Please confirm if the pump volume of washing needles are
between 390-410mg. If any abnormal found, please find out the
cause and fix it.
1.3 Prime sample arm for 30 times and observe if liquid leakage found
at the joints on sample arm’s waste pump, vacuum pump, dilution
pump, pressure sensor and valve. Please confirm if liquid drop
accumulates on needle’s tip and fix the malfunction if necessary.
1.4 Check the liquid level of coolant tank. If the remain amount is less
than 50% of the coolant tank, please replenish the coolant with the
same type.
1.5 Check the tubing of condensate water. Inject pure water with 50ml
at the out let of sample reagent area and observe if the condensate
water can flow outside successfully. Fix the abnormal if it exist.

I. Confirmation of Alarms and Status

The reason and


Confirmation of Alarms and Status Finish or not
solution for that
1.1 Check if liquid level detection function of system liquid and
waste liquid is normal.
1.2 Check if liquid level detection function of starters is normal.
1.3 Check if aspiration detection function of chamber waste needle
is normal.
1.4 Check if aspiration detection function of washer is normal.
1.5 Check if liquid level detection (LLD) function of pipette is normal.
Insert reagent kits and sample tubes with pure water and run LLD
for 100 times. The delta Z should be lower than 50.
1.6 Check the function of heating and cooling of incubator and
reagent area. Get to analyzer status interface of service software
and check if the temperature shown is the same as measured.
Check the voltage and humidity.

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Shenzhen New Industries Biomedical Engineering Co., Ltd.

J. Tube Cleaning and Priming

The reason and


Tube Cleaning and Priming Finish or not
solution for that
1.1 Execute the function of Tube Cleaning.
1.2 Prime the instrument 30 times for pipette, washer and chamber.
Repeat priming for 3 times.

K. Performance Evaluation

The reason and


Performance Evaluation Finish or not
solution for that
1. Macro Command Test
Execute program CuvetteRunning for 30min in service software
after initialization to confirm the moving parts align to each other
well.
2. BGW and LC Test
Load LC liquid at the 4th vial of reagent kit and insert this kit to the 20th slot. Record the current RLU factor. Run system
test. Edit the BGW and LC together, so that the affect on PMT performance during experiment will be found.
2.1 BGW for 10 times. The RLU should be between 100-1200 and
CV≤10%.
2.2 LC for 5 times. The RLU should be between 450000-650000
and CV≤3%.
3. Calibration
Execute calibration once. Record the RLU of each test, the
average and CV of RLU of high and low calibrator. Check whether
the calibration result is good.
4. QC Test
Select two levels QC for the related reagent kit, then run QC for
three times. Record the RLU and concentration. Check if the
results are within the range.

Engineer User
Date Date

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