CL-900i Series Alignment Guidance V1.0 EN
CL-900i Series Alignment Guidance V1.0 EN
CL-900i Series Alignment Guidance V1.0 EN
Chemiluminescence Immunoassay
Analyzer
Alignment Guidance
Table of Contents
Table of Contents .............................................................................................................................................. 2
Chapter 1 Tools/Auxiliary Materials ................................................................................................................ 5
1.1 Scope ........................................................................................................................................................ 5
1.2 List of Equipment Tools ............................................................................................................................. 5
1.3 Fixture Diagram ......................................................................................................................................... 6
1.4 Excipient List ............................................................................................................................................. 6
Chapter 2 Flow Block Diagram of Alignment Procedure ............................................................................. 7
Chapter 3 Preparations ................................................................................................................................... 8
3.1 Alignment Precautions ............................................................................................................................... 8
3.2 Powering on the Analyzer .......................................................................................................................... 8
3.3 Installing the Operation Software(Optional) ............................................................................................... 9
3.4 Screen Description .................................................................................................................................... 9
3.4.1 Start the operating software ................................................................................................................ 9
3.4.2 Alignment screen ................................................................................................................................ 9
3.5 Process Alignment Screen ...................................................................................................................... 10
Chapter 4 Backup and Restore of Parameters ............................................................................................. 13
4.1 Backing up the Parameters ..................................................................................................................... 13
4.2 Restoring the Parameters........................................................................................................................ 13
4.3 Modifying Parameters.............................................................................................................................. 14
Chapter 5 Dispersion System Alignment...................................................................................................... 17
5.2 Carousel Rotary Position Compensation ................................................................................................. 17
5.3 Probe Position Compensation When Aspirating ...................................................................................... 19
5.4 Extreme Position Inspection of Aspirating Vertical Mechanism ............................................................... 19
Chapter 6 Incubation Module Temperature Alignment ............................................................................... 21
6.1 Incubation Module Temperature Calibration ............................................................................................ 21
Chapter 7 Photometer System Alignment .................................................................................................... 25
7.1 Vertical Position of the Shielding Cover ................................................................................................... 26
7.2 PMT Parameter Setup ............................................................................................................................. 26
7.3 PMT Initialization ..................................................................................................................................... 27
Chapter 8 Dispensing System Alignment ..................................................................................................... 29
8.1 Checking the Probe ................................................................................................................................. 31
8.2 Coplanar Alignment of the Probe and the Mixer ...................................................................................... 31
8.3 HP of Probe Mixing Position 1 ................................................................................................................. 33
8.4 HP of Probe Mixing Position 2 ................................................................................................................. 33
8.5 HP of Probe Wash Well ........................................................................................................................... 34
8.6 HP of Probe Disk Ra Position .................................................................................................................. 34
8.7 HP of Probe Disk Rb Position .................................................................................................................. 35
8.8 HP of Probe Disk Rc Position .................................................................................................................. 36
8.9 HP of Probe Disk Rd Position .................................................................................................................. 36
8.10 HP of Probe Sample Position ................................................................................................................ 36
8.11 Bar Code Scanner Initialization.............................................................................................................. 37
No.: Version: V1.0 Page 2 of 90
IVD Global Technical Support Dept.
1.1 Scope
SN Code Parameter
1 / Purified water
2 105-004838-00 Acid wash buffer
Start
Alignment preparation
Incubation temperature
alignment
Temperature
alignment 1. Incubation
temperature calibration
Metering system
alignment
Metering system 1. Vertical position
Metering systemof the
alignment shieldingalignment
cover Transportation system
2. PMT parameter alignment 1
configuration
3. PMT initialization 1. Electromagnet check for
cuvette box
2. Finger’s home position
3. Discarding the horizontal
Transportation system
position
Dispersion system alignment Alignment 2
4. HP of the right cuvette box
1. Carousel rotary position 5. HP of the left cuvette box 1. VP of right cuvette box
Mechanical position compensation 6. Horizontal position of position
alignment 2. Probe position compensation incubation block 2. VP of left cuvette box position
when aspirating 7. HP of dispersion IO outlet 3. VP of incubation block
3. Extreme position check of the 8. HP of mixing position 1 4. VP of dispersion IO outlet
aspirating vertical mechanism 9. HP of mixing position 2 5. Vertical position of the mixing
10. HP of substrate mixing position
position
11. HP of discharging liquid level
Dispensing System\nAlignment 12. HP of photometric position
Fluidics Alignment
Other
1. Indicator check
Other alignments 2. Optical couplers check
3. Whole unit wash cuvette
4. Linked cuvette gripping
5. Reagent refrigeration temperature
check
End
Chapter 3 Preparations
Network
port 1
Network
port 2
2) Switch the main power to on and confirm the working status: all boards are powered on, the indicator is lit
on, and the two fans outside the power module are running. If the power supply presents abnormal smell
or smoke after being powered on, please power off for check immediately.
3) Remove the adhesive tapes used for covering the holes of the dispersion carousels and mixing components
completely (which can be torn off before the alignment after software installation).
4) After confirming that all parts work properly, perform subsequent alignment steps.
Figure 3.2 Application screen —> Maintenance —> Alignment (XX system alignment)
Z axis: ----Vertically upward, corresponding to the keyboard button "↑"; ---- vertically downward,
X axis: ---- Horizontal to left, corresponding to the keyboard button "←"; ---- horizontal to the right,
corresponding to the keyboard button "→" .
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IVD Global Technical Support Dept.
Y axis: ---- Horizontally backward, corresponding to the keyboard button "PgDn" ; ---- horizontally
Rotation direction: --- Clockwise rotation, corresponding to the keyboard button "Q"; ---
counterclockwise rotation, corresponding to the keyboard button "E" .
3. In the case of fine-tuning step, the edit box of step can be modified. The edit box of step can be activated
by pressing ALT+S in the keyboard. After entering the number, click "Enter" or press it in the keyboard to
complete the setup.
4. In each step, click Continue or press ALT+C to perform the next step.
5. In each step, click Cancel or press ALT+X to restore the initial value of the alignment parameter, execute
necessary reset actions, exit the alignment process and return to the previous unit screen.
Figure 3.3 Application interface > Maintenance > Alignment >XX alignment > XX process
Figure 4.1 Application screen > Maintenance > Alignment > Other > Common functions > Backup and
restore of parameters
Figure 4.2 Application screen > Maintenance > Alignment > Other > Common functions > Backup and
restore of parameters
Figure 4.3 Application screen > Maintenance > Alignment > Other > Common functions > Backup and
restore of parameters
Figure 4.4 Application screen > Maintenance > Alignment > Other > Common functions > Backup and
restore of parameters
Dispersion
carousel system
End
position IO tool (898-000720-00) gently, and observe whether the distances between the two sides of the fixture
and the two sides of the cover plate hole are even.
Alignment methods and procedure:
1) Click "1. Carousel rotary position compensation", and then click Continue to enter the next step.
2) According to the requirements and steps prompted by the software, place the alignment fixture 898-
000720-00 at the dispersion carousel position IO (placed gently and rough handling is not allowed. If it can't
be put in the hole naturally, adjust the parameters to appropriate position before placement). Click the
clockwise and counterclockwise arrows to adjust the compensation (remove the fixture before clicking the
arrows and continue. You should continue according to the software prompts. Observe whether the
distances between the two sides of the fixture and the two sides of the cover plate hole are even. If the light
is weak, you can observe with the help of the flashlight.
Note: After alignment of the position, it is necessary to align the "horizontal position of the dispersion carousel
IO outlet" in the transport system alignment again.
Clamp the
aspirating tube
and tighten the
manual nut
Press the probe
together with
the fixture, and
Close to the use a ruler to
898-000738-00 measure the
fixture bottom pressed gap. It
should be 1 to
1.2 mm.
(wiring between aspirating vertical mechanism motor and sensor) are not interfered with the other
components, and not twined. (Note: To the bottom position of the cuvette performs the vertical reset of
the aspirating needle first and then the needle moves to the bottom position of the cuvette.)
3) Step 3: Place the immune cuvette with 500μL (0.5ml) purified water at the incubation module position (4,
1), and insert the thermometer probe into the bottom of the cuvette for measurement. After the temperature
gets stable, measure the temperature and record it every 30S, with a total of 20 temperature values.
Figure 6.2 Position of the Cuvette for Incubation Module Temperature Test
Note 1: Insert the thermometer probe into the bottom of the cuvette, fix the probe (such as by using high
temperature tape) to prevent deviation, and then confirm that the probe cannot move downward with your hand,
or adjust the fixed position and angle of the probe connection, until the probe reaches the bottom of the cuvette.
Then, perform the test If you use high temperature tape for fixing, try not to stick to the surface of the incubation
module, and tear off the tape after the test is complete. Any residual gum on the surface of the incubation module
must be cleared carefully using the cotton stickers with alcohol, and make sure the fragments not fall into the
cuvette.
4) Step 4: Remove the thermometer after the test is complete; check the mean T within the range of 36.85℃
~37.15℃; according to the maximum value Tmax and minimum value Tmin, calculate the fluctuation degree
= (Tmax-Tmin), which is required to be ≤0.2℃.
5) Click Continue to enter the Temperature configuration screen; manually enter the thermometer
measured values (no matter whether the temperature accuracy exceeds the standard), and click OK. Click
Continue to complete the process; re-enter the process, and confirm the measured temperature according
to the method described in step (3) ~ (4); ultimately, it must meet the requirements of the index.
4) Press SETUP to enter SETUP screen; press NEXT for three times to select Date/Time, and then press
ENTER to enter date and time to set DATE/TIME ADJUST screen; switch and set the date and time using
NEXT, ↑ and ↓. After completion, press SETUP to return to the Home.
5) After 5 min of warming up the thermometer, test and record the data according to the following
instructions (you can also use a stopwatch and thermometer to record one value every 30s manually by
pressing SAVE):
◼ In the Home, press SHIFT successively and continuously (SHIFT displayed in the lower right corner
of the screen) and LOG to enter AUTO LOG screen.
◼ Press ↑ and ↓ to set INTERVAL to 30S, and press ENTER to accept it.
◼ Press NEXT to switch to START; press ENTER to start auto recording, the screen enters the auto recording
state, and the bottom of the screen shows the auto record number LOG 1 and corresponding auto timing
0:00:00; press SAVE once immediately to record first data SAV01; record number and timing jump once
every 30s; press SAVE once immediately to record one piece of data every time LOG n changes, until
the record number jumps to LOG 20, and press SAVE once to record the 20th data SAV20.
◼ Press SHIFT successively and continuously (SHIFT displayed in the lower right corner of the screen)
and LOG to enter AUTO LOG screen. The screen highlights STOP. Press ENTER to stop auto recording.
◼ Press RECALL to enter RECALL screen, and the screen highlights Review Saved; press ENTER to see
the state of the temperature record (the bottom of the screen shows RCL n YYMMDD hh:mm:ss); press
↑ and ↓ to see the temperature record RCL01 ~ RCL20.
◼ Press RECALL to exit the record check.
6) Calculate the average value T of the recorded 20 pieces of temperature data according to
(RCL01+RCL02+... +RCL20) /20, and record their maximum value Tmax and minimum value Tmin. You
cannot use STATS of the thermometer to see the maximum/minimum/mean value, which is not
corresponding to the temperature data recorded manually by pressing SAVE.
7) Clear all the data of manual recording SAVE and auto recording LOG in the thermometer after use.
8) Data Tag of auto recording LOG needs to be exported to the computer using the thermometer's matching
software and data line. Please refer to the instruction for use of the thermometer.
Note 2: The probes, as shown in the figure below should be protected; do not touch their heads and transparent
positions in the process of use; do not bend or extrude them; it is suggested that the transparent part of the
head should be protected with a hard protective sleeve immediately after use and put back in the packing box.
PMT Initialiation
End
Waste position
1) Click 1 shielding cover position alignment; prepare a fixture (898-000737-00) and a clean cuvette. Then,
power off the shielding cover, place the fixture (898-000737-00) on the incubation module; place a cuvette
in the waste drainage position through the fixture hole, and slightly unscrew the concave end fastening
screw of the waste discharge probe (the waste discharge probe can be moved when force is applied); move
the shielding cover down to make it fit with the fixture. Meanwhile, adjust the height of the waste discharge
probe so that the probe just stops at the bottom of the cuvette, and then tighten the top thread (torque
5~6kgf.cm).
2) Click OK to start auto calibration; the shielding cover automatically moves up, and stops at position zero to
complete auto calibration;
3) Click Continue to configure the parameters and finish the alignment.
Alignment index: PMT high voltage parameters and calibration factor τ1 and τ2 aligned in the photometer
module assembly are allocated to the whole unit.
Alignment methods and procedure:
1) Select 2 PMT parameter setup to pop up the photometer parameter configuration dialog box; manually
input the high voltage parameter HV and calibration factor τ1 and τ2 parameters aligned when the
photometer assembly is assembled, and click OK to finish the parameter configuration. Component data
should be corresponded one by one without mistakes.
1) Select 3 PMT initialization to enter the process; click Continue to pop up the Photometer initialization
screen; click Initialization for the first time to pop up the waiting time; if you are sure that the incubation
module temperature has been stable before alignment, just wait for 1min and click Cancel, and then
automatically perform subsequent alignments, and display alignment results; the results should comply
with the requirements of the index. You need to wait for 10min countdown before going on if you perform
the alignment immediately after powering on the instrument.
No.: Version: V1.0 Page 27 of
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IVD Global Technical Support Dept.
2) Automatically initialize the photometer, return the result after initialization, and show that the photometer is
initialized successfully.
Dispensing System\
nAlignment
End
When Z axis is powered off during the sample probe alignment, press down the arm manually, so that the probe
tip can be adjusted to align the alignment position. Note that:
1. Protect the probe to prevent damage. The downward force should be moderate, avoiding excessive force
and fast speed, so that the probe tip touches the fixture or other parts.
2. The arm is near the guide rail. To prevent the deformation of the rocker arm and deviation of the probe tip,
manually press the arm near the Z-axis guide rail.
3. Before clicking Continue, keep your hands and other parts of the body away from the machine running area
to prevent bruising.
4. When moving the sample probe horizontally, it is necessary to confirm that the sample probe has been
lifted and the probe tip enters the swab completely.
1. Confirm that the wiring of the liquid level detection runs outside the probe and does not interfere with the
solder joint (the solder joint and partial insulating skin are wrapped by glue without bare core line), and the
connection plug is inserted into the liquid level testing board.
2. Make sure that the hose rotates in a circle, penetrates the cable tie clockwise at the bottom of the arm (the
cable tie cannot extrude tubes), and then is inserted into the probe; the hose is inserted over the step
surface. Adjust the size of the hose arc to ensure that the hose does not interfere with probe core.
Figure 8.5 Schematic Diagram of the Inner Wall Pipe of Sample Probe
3. Manually lift the probe to simulate probe collision. The probe should be able to fall to the bottom with no
stagnation; when the block shields the optical coupler, lamp D1 on the liquid level detection board is off,
and otherwise it is on. Observe the block is located in the center of optical coupler, with no contact with the
optical coupler.
Select Continue to save parameters and finish the alignment. Check that the four adjusting screws are
tightened firmly (torque 6~8kgf.cm).
NOTE
1. If the deviation between the front and rear centers of the wash well is large, you can loosen the fastening
screws on the wash well bracket and the upper cover plate to adjust them slightly.
2. After the process is completed, you need to re-align HP of probe mixing position 1, HP of probe mixing
position 2, HP of probe wash well, HP of mixing position 1 and HP of mixing position 2 in the transport
system alignment.
3. When moving the sample probe horizontally, it is necessary to confirm that the sample probe has been
lifted and the probe tip enters the swab completely.
6# position loading
reagent bottle
reagent carousel Ra stop position in order to insert the sample probe precisely into the Rb position’s cross
center of the reagent box.
Alignment methods and procedure:
Click 6 HP of probe disk Rb position; load a reagent bottle at the reagent carousel 6#; move the probe above
Rb position; manually press the Z axis drive to make the probe close to the Rb position’s cross center; if there
is a deviation, click the left and right, clockwise and counterclockwise arrows to adjust the probe position and
the reagent carousel position until meeting the requirements; click Continue to confirm whether the
requirements are met; if not, click the right and left arrows until meeting the requirements.
Select Continue to save parameters and finish the alignment.
Click 9 HP alignment of probe sample position; place alignment fixture 898-000733-00 at the sampling
position according to the software prompts and steps; the sample carousel rotates counter clockwise and stops
at the sample position; move the probe above the sample position, and press the Z axis manually to make the
probe close to the fixture center hole; if a deviation exists, click the left and right arrows and clockwise and
counter clockwise arrows to adjust the left and right position of the probe and the counterclockwise stop
position parameters of the sample carousel to meet the index requirements.
Click Continue to confirm if the sample probe is aligned with the hole of the fixture. If a deviation exists, click
the arrows again to adjust the position until it meets the requirement.
Click Continue; the sample carousel stops at the sample position clockwise; press the Z axis drive manually to
make the probe close to the fixture center hole; if a deviation exists, click the clockwise and counter clockwise
arrows to adjust the clockwise stop position parameters of the sample carousel to meet the index requirements.
Select Continue to save parameters and finish the alignment.
Particular attention: Confirmation cannot be omitted. If you detect an HP deviation during confirmation, align
again until the requirement is met.
Figure 8.12 Schematic Diagram of the Reagent Box Bar Code Paste
Click 11 Reagent carousel bar code scanning check; click the clockwise and counter clockwise on the screen
following the software prompts; place reagent boxes with reagent bar codes at all reagent positions; enter the
scanning screen and enter the scan times: 5 (cycles); click Start to scan the bar codes; feed back the
identification information, which should be consistent with the actual bar codes; the results of repeated scanning
comparison are consistent.
If NG exists,
confirm it, and
perform check
again till all the
reagent
positions are
OK
The comparison
result is OK, and
all the bar codes
scanned
repeatedly 5 times
are identified and
Change to 5 consistent
Click 12 Sample carousel bar code scanning check; click the clockwise and counter clockwise following the
software prompts; place tubes with sample bar codes at all sample carousel positions; enter the scanning
screen and enter the scan times: 5 (cycles); click Start to scan the bar codes; feed back the identification
information, which should be consistent with the actual bar codes; the results of repeated scanning
comparison are consistent.
Select OK to finish the alignment.
Click OK to start auto calibration; the probe is powered on, rises automatically and stops after finding position
Click OK to start auto calibration; the probe is powered on, rises automatically and stops after finding position
zero; the parameters are calculated, obtained, and configured automatically.
Select Continue to finish the alignment.
Transportation
system alignment
HP of cuvette
HP of the right HP of the left HP of mixing HP of mixing HP of substrate mixing HP of dispersion IO HP of incubation HP of photometric HP of discharging
discarding
cuvette box cuvette box position 1 position 2 position port block position liquid level
position
End
NOTE
1. When adjusting the horizontal position of the gripper, manually press the center position of the upper
plane of the Z axis motor; do not press it forcedly to avoid collision.
2. When adjusting the horizontal position of the gripper, first roughly align the fixture hole center; do not
clear microstep movement when pressing the arrows to adjust the position. If offset exists in the case of
confirmation, microstep alignment can be performed again. At this time, microstep movement is zeroed,
and make sure to avoid collision with your hands and body.
3. The alignment fixture axis on your finger cannot be pressed into the fixture hole in the target position
forcedly. After alignment, gently press it down to the hole, and make sure the gap is uniform around it.
You can also rotate the fixture below. It should be rotated smoothly and cannot be choked by the axis.
Use fingers to
press gently
Even gaps
around the
circumference
Big cam
Small cam
Note: If the waste container welds are not mounted, the position can be aligned after the welds are mounted,
but before discarding.
Place three
tools at these
three positions
at a time
2) Click 4. HP of the right cuvette box; pull out the tray according to the software prompts and steps; load
the ready cuvette box and fixture on the tray, and place fixture BM10-J08-007 on the finger. According to
the software prompts, HP of 3 cuvette position holes in the right cuvette box is aligned; the fixture shaft
should be aligned with the hole of the pseudo cuvette fixture, and the clearance is uniform; otherwise, you
should adjust the position of the gripper’s X and Y axes using the front/rear and right/left arrow buttons until
the requirements are met. After each position alignment is finished, click Continue to confirm whether the
position alignment meets the requirements. If not, click the arrow buttons again to adjust the position
(confirm the step microstep movement is zeroed, and avoid collision) until the requirements are met. Put
the fixture into the drawer when the drawer magnet is powered off, and then push the drawer for attracting
to prevent alignment errors.
Place alignment
tools at these
three positions
2) Click 6. HP of incubation module. Position alignment is completed following the software prompts and
steps. The fixture shaft should be aligned with the hole of the pseudo cuvette fixture, and the clearance is
uniform; otherwise, you should adjust the position of the gripper’s X and Y axes using the front/rear and
right/left arrow buttons until the requirements are met. Click Continue to confirm whether the position
alignment meets the requirements. If not, click the arrow button again to adjust the position (confirm the
step microstep movement is zeroed, and avoid collision) until the requirements are met.
Fixture 898-000720-00
2) The fixture shaft should be aligned with the center hole of the fixture, and the clearance is uniform; otherwise,
you should adjust the position of the gripper’s X and Y axes using the front/rear and right/left arrow buttons
until the requirements are met. Click Continue to confirm whether the position alignment meets the
requirements. If not, click the arrow button again to adjust the position (confirm the step microstep
movement is zeroed, and avoid collision) until the requirements are met.
the requirements are met. Click Continue to confirm whether the position alignment meets the
requirements. If not, click the arrow button again to adjust the position (confirm the step microstep
movement is zeroed, and avoid collision) until the requirements are met.
Place alignment
tool at the waste
drainage position
2) Click 11. HP of waste drainage position. Finger adjustment fixture BM10-J08-007 and sample
position pseudo cuvette fixture BM10-J05-002 are aligned following the software prompts and steps.
The fixture shaft should be aligned with the hole of the pseudo cuvette fixture, and the clearance is
uniform; otherwise, you should adjust the position of the gripper’s X and Y axes using the front/rear
and right/left arrow buttons until the requirements are met. Click Continue to confirm whether the
position alignment meets the requirements. If not, click the arrow button again to adjust the position
(confirm the step microstep movement is zeroed, and avoid collision) until the requirements are met.
Place alignment
tool at the
photometric
position
2) Click 12. HP of photometer position. The finger fixture BM10-J08-007 and sample position pseudo
cuvette fixture BM10-J05-002 are aligned following the software prompts and steps. The fixture shaft
should be aligned with the hole of the pseudo cuvette fixture, and the clearance is uniform; otherwise,
you should adjust the position of the gripper’s X and Y axes using the front/rear and right/left arrow
buttons until the requirements are met. Click Continue to confirm whether the position alignment
meets the requirements. If not, click the arrow button again to adjust the position (confirm the step
microstep movement is zeroed, and avoid collision) until the requirements are met.
Place the
depth
fixture in
the cuvette
Place fixtures
The fixture at four corners
bottom
edge can
be seen
2) Click 13. VP of right cuvette box position. Gripping is performed at the cuvette positions at four corners
from the finger to the right cuvette box following the software prompts and steps; visually check whether
the bottom edge of the gripper is aligned with the bottom edge of the gripper depth fixture groove in the
cuvette. If not, click the up/down arrow buttons to adjust the gripper until the requirements are met.
Place fixtures at
four corners
2) Click 15. VP of Incubating Position. Gripping is performed at four corners from the finger to the incubating
position following the software prompts and steps; visually check whether the bottom edge of the gripper
is aligned with the bottom edge of the gripper depth fixture groove in the cuvette. If not, click the up/down
arrow buttons to adjust the gripper until the requirements are met.
IO following the software prompts and steps; visually check whether the bottom edge of the gripper is
aligned with the bottom edge of the gripper depth fixture groove in the cuvette. If not, click the up/down
arrow buttons to adjust the gripper until the requirements are met.
Wa sh
buffer 1
Wa sh
buffer 2
Note: After loading the wash buffer, barrels for wash buffer 1 and wash buffer 2 are not allowed to be exchanged
with each other.
Use purified water substrate 1 Empty the positions of substrate Use acid lotion substrate 1 and Empty the positions of substrate
and substrate 2 to carry out 1 and substrate 2 16 times substrate 2 to carry out cleaning 1 and substrate 2 16 times
cleaning 16 times respectively respectively 16 times respectively respectively
Use purified water substrate 1 Empty the positions of substrate Use substrate 1 and substrate 2
and substrate 2 to carry out 1 and substrate 2 16 times Load substrate 1 and substrate 2 for priming 25 times
cleaning 16 times respectively respectively respectively
Note: Remove the screws carefully to avoid them from falling into the dispersion carousel; in this process, cover
the dispersion carousel IO outlet with high temperature tape and remove the tape after the operation.
Protect the substrate tube from bending. Protect the hose at the substrate joint and the joint outlet from
contamination.
5) Step 2: Clean the substrate tube with purified water, and fill purified water in the two clean substrate bottles;
load them to positions of substrate L and substrate R, and then click Clean substrate on the software;
confirm that the operation is performed as required, and click OK to enter the cleaning screen. [Execution
Times] is 16 by default; the system automatically starts to clean the substrate channel L and channel R with
purified water; during the cleaning process, observe that the screen prompt turns gradually to bubbles are
not detected in substrate tube. Observe that the joints of the substrate tube are inserted in place without
leakage.
Insert the
conversion tube
in position
Insert the
conversion tube
to the root of
electromagnetic
valve connector
6) Click Continue to go to step 3; empty the pure water in the substrate tube; remove the clean substrate
bottles with purified water at substrate L and substrate R; Click Empty substrate. The system indicates
that the substrate should be emptied. Confirm it and enter the empty screen. Set [Execution times] to default
to empty the purified water in channel L and channel R, and observe that the screen prompt turns gradually
to bubbles are detected in substrate tube, and then exit the screen after completion.
7) Click Continue to go to step 4; clean the substrate tube with acid wash buffer; fill substrate bottles L and R
with acid wash buffer, and loosen the bottle caps; click Clean substrate, confirm that the two substrate
positions have been loaded with acid wash buffer; enter the wash screen, and set [Execution times] to
default; the system automatically starts to clean the substrate channel with acid wash buffer, and the screen
prompt turns gradually to bubbles are not detected in substrate tube. Exit the screen after completion.
8) Click Continue to go to step 5; empty the acid wash buffer in the substrate tube; click Empty substrate,
remove the acid wash buffer bottles of substrates L and R according to the prompt, and click OK to enter
the empty screen. Set [Execution times] to default to empty the acid wash buffer in channel L and channel
R, and observe that the screen prompt turns gradually to bubbles are detected in substrate tube, and
then exit the screen after completion.
9) Click Continue to go to step 6; clean the substrate tube again with purified water; click Clean substrate,
replace the purified water in the two clean substrate bottles according to the prompt; load them to positions
of substrate L and substrate R; enter the wash screen, and set [Execution times] to default; The system
automatically starts to clean the substrate channels L and R with purified water, and the screen prompt
turns gradually to bubbles are not detected in substrate tube. Exit the screen after completion.
10) Click Continue to go to step 7; empty the purified water in the substrate tube; click Empty substrate,
remove the purified water bottles of substrates L and R according to the prompt, and click OK to enter the
empty screen. Set [Execution times] to default to empty the purified water in channel L and channel R, and
observe that the screen prompt turns gradually to bubbles are detected in substrate tube, and then exit
the screen after completion.
11) After the substrate cleaning is completed, the screen prompts to restore the tubing installation. Because
you need to prime the substrate later, you can temporarily leave it. Tap Continue to complete the process;
Priming substrate:
1) Prepare balanced substrate; check that the balance time has 6 hours, and the substrate is within the shelf
life.
Material Code Material Description Quantity
Chemiluminescent 2 bottles
105-002608-00
substrate solution
2) Exit the alignment screen; enter Reagent - > Material management screen, and select Substrate L, and
then click Load to pop up the loading screen; use a hand-held bar code reader to scan the bar code of the
substrate bottle, and load the identified substrate bottle (tear off the bottom foil of the substrate bottle) to
the position of substrate L. Load substrate R using the same method. After loading, loosen the substrate
bottle cap for further priming.
3) Return to Utility > Alignment > Fluidics Alignment; enter 4. Substrate Fluidic Prime (Note: do not enter 2.
Clean substrate tube), and click Continue to process the substrate tube following the screen prompts; the
step aims only to confirm the tube because the substrate tube is cleaned and not restored.
4) Go to step 2, and select the tube Substrate L& substrate R loaded with substrate, confirm that substrate is
loaded to the substrate L and substrate R according to the prompt. Click OK to automatically enter the
priming screen and start to prime. Substrate L and substrate R are primed for 25 times, and the tube status
should be Normal. The system exits the screen automatically when the operation is done. (If the priming is
interrupted midway, in order to avoid abnormality of the subsequent tests, you need to restart the process
to perform the complete priming process.)
Note: Carefully install the screws. Do not drop screws into the dispersion carousel. Remove the protection cover
for the IO port of the dispersion carousel at the last step.
Protect the substrate tube from bending. Protect the hose at the substrate joint and the joint outlet from
contamination.
Make sure the three hand-operated nuts are tightened.
Insertion depth of
substrate drain tube
must be over 2 mm
Confirm it is
tightened
Remove at last
Fix with cable tie
Establish
Vacuum
-30
2) Click Start. The screen starts to draw the pressure curve. Execute Establish Vacuum. After the pressure
becomes stable, the primary vacuum pressure displayed should be no more than -30KPa. Then, execute
Release Vacuum and exit the page.
Note: Observe the pressure curve continuously. The pressure curve should be kept straight without gradual
upward trend. Otherwise, confirm whether leakage exists in the vacuum tube.
the screen in the case of alignment. Fill a syringe with purified water for use.
5) Step 2: Click Reagent Compartment Draining in the lower right corner and enter Reagent Compartment
Draining screen; fill purified water slowly along the pot wall from the reagent pot suction plate window
(shown in the figure below), and execute the drainage for several times. In the process of drainage, confirm
the drainage tube runs to V10, V11, V12 and then to V13, to LP2 waste pump, and finally discharges from
the waste tube of liquid outlet. The tube is free from leakage, extrusion and bending, and the waste pump
runs smoothly. Then, click Continue after check.
Use a syringe to
inject purified
water from this
position (hole at
the carousel
bottom)
⚫ Observe that the waste flows normally in the waste tube from the left side of the reagent carousel, bottom
of the reagent pot and the liquid inlet and outlet.
⚫ And confirm that the tube is not extruded or bent, and is free of leakage.
6) Step 3: Place a cuvette full of water in the Waste Drainage Position, and then click Waste Drainage at the
bottom right corner. A prompt box pops up: A cuvette full of water is place in the Waste Drainage
Position before waste drainage. Then, click OK to execute waste drainage once, and confirm that the
suction tube runs to the vacuum chamber, and then to LP2 waste pump, that the tube is free from leakage,
extrusion and bending, that the waste pump runs smoothly, and that the hose connected to the waste
discharge probe is clamped into the infusion tube clamp. Then, click Exit and operate according to the
prompt "Please remove the cuvette at the waste drainage position".
⚫ Remove the cuvette and confirm that there is no residual liquid at its bottom (liquid beads on the wall are
normal).
7) Select Continue to exit the screen.
Waste pipe
clamped in the
The pipeline perfusion tube
cannot be folded clamp
the liquid to be continuously ejected from the sample probe. (Stop immediately and check it if leakage
occurs during execution or the liquid enters into the tube slowly).
Note:
⚫ Set the priming times to default first. After completion, the probe inner and outer wall tubes should be filled.
If the tubes are not full or no liquid can be observed (the screen indicates bubbles detected), it is necessary
to confirm if the tubes are connected correctly.
⚫ Priming should be performed for both wash buffer 1 and wash buffer 2; bottle cap tube of wash buffer 2
should be kept empty when wash buffer 1 is primed, and vice versa. Otherwise, it is not easy to find the
incorrect connection of wash buffer 1 and wash buffer 2.
⚫ When performing priming, run the sample probe first into the wash well to perform inner wall priming. Then,
life the probe to carry out outer wall and swab priming.
7) Confirm the two inlet tubes of wash buffer 1 and wash buffer 2 and the probe sampling tube. The wash
buffers should run to V15 and V16 from the inlets; two syringes, V17, probe, swab, tubes and joints are
free of leakage; confirm that the tubes of the two wash buffer check assemblies are filled with liquid with no
bubbles; after the liquid is primed, the sensor indicator is off; the two sensors correspond one by one, 1
connecting wash buffer bucket 1 and 2 connecting the wash buffer bucket 2; the software screen indicates
that tubes of wash buffer 1 and wash buffer 2 are connected correctly, and no bubbles are detected.
The indicator
The indicator is
goes out after
on (which can be
liquid is primed observed at the
board back) in the
priming status
8) Observe the sample probe can eject fluid continuously into the wash well.
Figure 10.15 Schematic Diagram of Prime Sample Probe Inner Wall Wash Tubes
9) When cleaning and priming probe outer wall, observe the swab tube is filled with liquid, and no liquid drips
from the swab after the priming is completed.
The liquid
inlet pipe is Inserted in
filled with position
liquid and free
of air bubbles
Figure 10.16 Schematic Diagram of Prime Sample Probe Outer Wall Wash Tubes
10) Check and confirm that the waste tube connected to the swab runs to V18, and the wash well to V18, and
then from V18 to waste pump LP1 and finally to the liquid inlet and outlet, with on leakage, and the liquid is
smoothly discharged to the waste barrel.
No.: Version: V1.0 Page 67 of
90
IVD Global Technical Support Dept.
Waste 1 tube
drains waste
Pressure
curve stable
Figure 10.18 Check Hydraulic Pressure on Sample Probe Aspirating and Draining screen
Note: The system detects automatically, performs syringe suction, slow and fast drainage, and automatically
Violently
fluctuating
Unstable
Check if the
aspirating/drainage
pipeline of sample
probe leaks
Figure 10.19 Check of Hydraulic Pressure Exception on Sample Probe Aspirating and Draining
Aspirating probe
The sample installation position
probe aspirates Aspirating probe of phase 1
liquid. Observe installation position
the process that of phase 3
the pipe changes
from the empty
status to the
liquid aspirating
status, and the
liquid column
moves until the
pipe is filled.
Click Continue. The screen will instruct you to wipe phase-1 aspirating probe with dust cloth and put it back in
place.
3) Step 3: Perform Phase-2 Aspiration with the same method; perform multiple dispersion aspirations, and
observe whether phase-2 dispersion aspirating tube is full of wash buffer with no leakage, and liquid is
discharged from the waste tube.
4) Step 4: Perform Phase-3 Aspiration with the same method; perform multiple dispersion aspirations, and
observe whether phase-3 dispersion aspirating tube is full of wash buffer with no leakage, and liquid is
discharged from the waste tube.
5) Click Continue to exit the screen after completion; clean the aspirating probe with dust-free cloth and put
it back; the tubes should be connected correctly: phase-1 T38 connects to V06, phase-2 T42 connects to
V07, and phase-3 T46 connects to V08. The tubes are mounted back in place; the tubes are smooth without
bending, and are clamped into the infusion tube clamp.
The dispersion
aspirating tube
has been
clamped into the
perfusion tube Aspirating probe
clamp installation
position of phase 1
Aspirating probe
installation position
of phase 3
Note: Phase-1, phase-2 and phase-3 aspirating tubes are confirmed one by one and connected correctly.
⚫ After wash buffer 1 priming is completed, perform wash buffer 2 priming with the same method, remove the
bottle cap tube of wash buffer 1 and put the bottle cap tube of wash buffer 2 below the purified water level,
aiming to fill T16 tube; confirm that the tube is free of extrusion, bending and leakage.
⚫ Times of priming: The tube can be filled by default under normal circumstances. If no liquid is observed,
check if the tube is connected correctly.
⚫ Dispersion wash tube swab inlet pipe (below, thin) and outlet pipe (above, large) can not be connected
reversely.
Pipe clamped in
the perfusion
tube clamp
Phase-2 drain tubes
5) Step 4: Click Emptying/Priming at the lower right corner; perform phase-3 wash tube priming with the
method in step 2; observe whether the tube from V20 to swab is filled with liquid, and waste is discharged
from the swab, with no leakage (perform wash buffer 1 priming only).
Pipe clamped in
the perfusion
tube clamp
Figure 10.27 Schematic Diagram of Prime Dispersion Dispensing Tubes - Place Cuvettes
2) Step 2: Perform phase-1 dispensing tube priming; click Check at the lower right corner. The screen prompts
When priming, please connect wash buffer 1 and wash buffer 2 at fluidics inlet to the purified water
buckets, and connect the waste bucket; click OK to enter the priming screen; input the number of priming,
and select Wash buffer 1 (only wash buffer 1 is used in this step because the wash buffer 2 barrel has
been filled in the last step) to prime wash buffer 1 for several times (the number of priming is default);
observe the priming of wash buffer 1 and tubes filled with liquid (stop immediately and check it if leakage
exists or liquid enters into the tube slowly).
Note:
⚫ For wash buffer 1 inlet tube and dispersion dispensing tube, confirm that the wash buffer inlet runs to V14,
V01, and then to syringe when intaking; it runs from the syringe to V01 and V02 (phase-1 tube T24 connects
to V02, phase-2 tube T27 connects to V03, and phase-3 tube T31 connects to V04), and then to dispensing
probe. The tube is filled with liquid, and tubes and connectors are free of leakage.
⚫ Take the default number of priming. It is necessary to confirm whether the tubes are connected properly if
the tube is still not filled or no liquid is found after completion.
⚫ In order to avoid connection error of dispensing tubes, the 3 phases of dispensing tubes will aspirate fluid
in turn in the process of dispersion and priming. After priming is completed, observe whether the liquid
primed into the cuvette by the aspirating probe tube is aspirated. Remove the cuvette after completion; the
liquid should be emptied.
2nd
column
Pipe clamped
in the
3rd perfusion tube
column clamp
1st
column
Preh eating
3) Step 3: Perform phase-2 dispensing tube priming with the same method in step 2; prime wash buffer 1 (the
number of priming is default), and observe wash buffer 1 priming; the tube is filled with liquid gradually, and
tubes and connectors are free of leakage (stop immediately and check it if leakage exists or liquid enters
into the tube slowly).
4) Step 4: Perform phase-3 dispensing tube priming as in step 2; prime wash buffer 1 (the number of priming
is default), and observe wash buffer 1 priming (phase-3 dispensing tube is preheated by the incubation
module, and the tube is longer. The number of priming is greater than that of the first two phases); wait for
the fluid to be ejected continuously from the dispensing probe (stop immediately and check it if leakage
exists or liquid enters into the tube slowly). The tube is filled with liquid gradually, and tubes and connectors
are free of leakage. Finally, click OK to exit the screen.
5) Click Continue to enter Waste drain tube checking, and execute automatically once; grippe the cuvette
to the waste drainage position; perform waste tubing wash priming, and observe whether the tubes between,
in front of and behind V23 and V09 are filled with liquid, with no leakage. After completion, discard the
cuvette and exit the process.
No.: Version: V1.0 Page 77 of
90
IVD Global Technical Support Dept.
Figure 10.29 Screen of Prime and Check Waste Drainage Probe Wash Tubes
Note:
⚫ Observe the three phases of dispensing tubes, without bending and breaking;
⚫ If the priming fails, confirm whether the dispersion carousel overflows. If overflow exists, it is necessary to
remove the aspirating and dispensing mechanism to check and remove the overflow from the dispersion
pot, and start priming after the trouble is eliminated.
⚫ Priming must be executed in accordance with the sequence of the process. If you click Continue and skip
a phase priming by mistake, click Cancel to exit the process to start again.
⚫ Do not miss the inspection of the waste drainage wash tube.
waste floater when the waste bucket is not used; Note that correct BM50 waste floater sensor 115-
050123-00 should be used because it is different from other products).
3) Tube of wash buffer 1 or wash buffer 2 is connected to the corresponding wash buffer bucket (the
wash buffer bucket is connected based on the actual use; a bucket of wash buffer is enough usually).
Wash buffer 1
Wash buffer 2
Note: Wash buffer 1 of fluidics inlet is connected to the wash buffer bottle cap component marked with "1”, and
wash buffer 2 is connected to the wash buffer bottle cap component marked with "2". If wash buffer 1 and wash
buffer 2 are loaded, their buckets can not be exchanged.
4) Load wash buffer: Enter Reagent > Consumables management; load wash buffer 1 or wash buffer 2 as
required; input the inventory and click Load.
Note: The buckets connected to wash buffer 1 bottle cap component and wash buffer 2 bottle cap component
No.: Version: V1.0 Page 79 of
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IVD Global Technical Support Dept.
cannot be exchanged. If part of the wash buffer is left after testing, mark the wash buffer inventory XX% on the
screen and the bucket in order to reduce waste. When loading the wash buffer bucket again in the future, you
can fill in the inventory XX% directly. Try not to use the wash buffer with other models. Otherwise, the inventory
may be inaccurate, resulting in intaking failure.
5) Enter Alignment - Fluidics Alignment, perform the priming process, and confirm that all tubes are normal
and free of bubbles after the wash buffer is replaced.
Enter the Wash buffer tube priming process, click Continue, and place a cuvette at the lower right corner
of the left tray following prompts.
Select a tube loaded with wash buffer, and then click Continue.
When entering the priming screen, the system automatically primes the sampling probe tube, dispersion
wash tube and dispensing tube, and the state of corresponding tubes is returned on the screen.
After execution, alignment procedure is completed; the left tray can be loaded again, and a cuvette is added.
Note: After the above priming is completed, you can enter Reagent > Consumables management, and
perform Recover wash buffer if the tube is abnormal and has bubbles during follow-up test process.
Perform System recovery, wait for completion of system recovery, and switch the state to Standby. (If the
system is in standby, skip this step);
Front
facade
4X20 screw
Indicator of the
Waste Container
Key
Indicator of disk
Indicator of disk Left-Turn key
Left-Turn key
Indicator of disk Right-Turn key
Indicator of disk
Right-Turn key
Indicator
Indicator ofof
the the
Indicator of the
Indicator of the Indicator of
Substrate Start indicator (press)
Substrate L Key
Substrate L Key Substrate RRKey
Key
the Start Key
3) Instructions to lamps on the transparent shielding cover and panel are as shown in the figure above. Select
any indicator and click on-off. The indicator should work accordingly with same light color and light intensity,
without obvious differences and defects. Note: Check the indicators of the same group and same assembly
or close to each other to make sure their cables are correctly connected.
4) Note: Exit the screen after check, and confirm that all indicators are off.
2) Simulate blocking the left and right anti-collision optical couplers of the sample carousel. The check results
should be correct in block and unblock statuses.
3) It is unblock when the waste tank is removed; otherwise, it is block. Exit the screen after the check.
2) Enter Alignment - > Other, click 5. Whole Unit Discarding Cuvette, enter the process. The software
automatically discards the cuvettes at the incubating position, photometer position, waste drainage position,
mixing positions and dispersion operation position. All the cuvettes are cleared and discarded into the waste
container. During this process, there should be no empty gripping, bumping or dropping of cuvettes.
3) When gripping at the dispersion IO outlet, observe the gripper should not interfere with the dispersion hose.
4) In the process of gripping, observe that FPC should not be rubbed or interfered with other components.
Note:
⚫ The cuvettes used in linked cuvette gripping test can be reused. It is not recommended to use these
cuvettes for other performance tests.
Refrigeration
Temperature