eCL800 Installation Procedures

1- Prepare the System Water: Mix 9L of distilled water with 1L of

Concentrated Washing Buffer before 2 hours of installing the machine.

2- Unpackage the machine and remove the four fixtures.

3- Install the reference electrode in the right side.

4- Load system reagents Auffer and Buffer:

- Remove the reagent cap and bubbles inside, then cover the silicone
cap.
- Auffer on the right, Buffer on the left.

(1) Buffer
(2) Auffer

5- Turn on the system and the refrigerator at the same time.

6- Enter user: admin & password: admin.

7- Do system initialization: Setting → Maintenance → System Initialization.

(do it for 3 times)

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8- Loading immunoreagent:
- Place the Reagent Card in front of the Scanner rea to read the
reagent information, and then put it into the Immunoreagent
Compartment after the reagent information interface pops up and
press Loading.
- It is only allowed when the system status is "Standby".
- It will take 30 min.
9- Loading assay cups: System → Press on any cup → it will move toward
you → Change new incubation cup → OK.
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10- Do blank test: Setting → Advanced → User: root & Password: lifo5689 →
Performance Maintenance → Blank Test → Start.
- Wait until 10 results displayed then delete the first result.
- CV should be <5%.
- Average between 100 – 1000.
11- Do measuring cell maintenance: Setting → Maintenance → Measuring
Cell Maintenance.
- Replace the Auffer reagent with Measuring Cell Maintenance Buffer.
- After finishing this procedure change back the Measuring Cell
Maintenance Buffer to Auffer reagent.

12- Do high pressure adjustment: Setting → Advanced → User: root &

Password: lifo5689 → Performance Maintenance → High pressure
adjustment → Start.
- Change the Buffer reagent with High Voltage Adjustment Buffer.
- Load the High Voltage Adjustment Reagent in no.3 in
Immunoreagent Compartment.
- The Assay Cup must be located in A area.
- Wait until 10 results displayed then delete the first result.
- CV should be <3%.
- Average between 100000 ±5000.
 Note: Change the Assay Cup after the High Pressure Adjustment
because the data of this procedure will not recorded.
- If the results are abnormal; change he reagent. If the results still
abnormal adjust the potentiometer on the top of the machine during
the test.
- Change back the Buffer reagent and replace the Assay Cup in A area.
13- Calibration of reagent: Reagents → Edit Cal. → Pic →Choose the High
Cal. at first then choose the Low Cal. next → Save →
- On the sample rack, place the High Value and Low Value calibrators
in order the High Value first then the Low Value.
- Unscrew the bottle cap and insert the rack.
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High

Low

High
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Low

- After the test is complete, go to Reagents → Start Cal. → Calibrate;

to complete the calibration.
- Calibration pass conditions:
 High and low value signal deviation requirements: ± 70%.
 High and low value deviation differences (high value minus the
low value signal deviation) requires ± 30%.
 Test signal CV requirements: low value <5%, high value <3%.
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- If the calibration test does not meet the Calibration pass conditions,
a warning will be shown above the Calibration Curve graph indicate
the test failed, then the calibration test may be repeated.

14- QC of reagent:
- After the calibration is completed, scan the QC card (from the PCT
kit) in the RFID, the following window will pop up automatically, and
click "Loading".
- Place the Low Value QC and High Value QC on the sample rack
(there is no order requirement). Be sure to unscrew the bottle cap.
- After loading; go to Edit → Test Edit.

- Click the place where the low-QC located, select “QC”, select the
corresponding lot number for the low QC, and select L (low level)
for the QC level, do the same operation of high QC and select H
(high level).
- Select "OK" after you have finished.
- Click to start the test
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- After the test is completed, the QC results will appear in the QC

interface and you can choose L for Low QC level and H for High QC
level.
 - QC pass condition:

- If the QC result dot on the

Graph is showing YELLOW, the
QC test should be repeated.

- If the second QC result dot on

the Graph is showing YELLOW If the QC result dot on the
again, QC Failed. Graph is showing RED, QC
Failed.

If the QC result dot on the

Graph is showing GREEN, QC
Passed.