H30 Installation Guidance

2018/10/10
H30 Installation Guidance
Content

1 Installation Requirements
2 Electric and Hydraulic Connections
3 Reagent Prime & Start-up
4 Quality Control Test
5 Calibration (if needed)
6 QC Verification(if needed)
7 Sample Test

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Installation Requirements
Environmental Requirements
• Ambient Temperature between 18°C and 32 °C.
• Relative Humidity no greater than 80%.
• Keep the analyzer away from direct exposure to strong
sunlight.
• Place main unit and Diluent box at the same level in case
of diluent aspiration failure.
• Place main unit onto a clean and flat surface with at least
10 cm at the rear of the analyzer for well-ventilation and 30
cm on the left and right side for reagents replacement and
maintenance of fluidic module respectively.

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Electric and Hydraulic Connections
1. Lyse and Cleaner Connection

• Open the lyse and cleaner containers respectively.

• Open the reagents chamber
• Insert the tube into the right container by matching
the color of sleeve and bottle. Chamber door switch
Blue sleeve  Cleaner
Yellow sleeve  Lyse
• Put the reagents containers in the reagents chamber
and close the chamber door.

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Diluent Tube
Electric and Hydraulic Connections Connector

2. Diluent and Waste Connection

• Open the Diluent and Waste containers respectively.

• Insert the opposite end of the diluent and waste
tubing connector into the diluent and waste
container respectively and secure the cap on the
diluent container and waste container respectively.
White sleeve  Diluent
Red sleeve  Waste
Note:
*Make sure diluent box is at the same level of H30
*Keep the diluent cap in case of transportation of
diluent box

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Electric and Hydraulic Connections
3. Printer paper installation & Power connection
Paper roll
• Gently place the paper in the paper tray with the
position shown as the right picture
• Pull about 2 cm of paper out and close the printer
casing.
• Connect the main cord to the power supply block.
• Connect the power supply to the instrument located
at the rear of the instrument.
Power port

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Reagent prime
1. Switch on the analyzer by clicking power
button.
2. Log in the analzyer:
Account: ADMIN
Password: 123456
If a hint “motor ini cycle not done” pops up,
please go to service> click SYSTEM INIT
3. Go to Reagent - click DILUENT, LYSE and
CLEANER to input the reagent information
4. Barcode scanner can be used, but it has to
scan both two barcodes
5. For manually input information, the coding rule
is (take the picture on the right as an example) :
Lot: D1711003
SERIAL: 00002
CODE: 16D0
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Reagent prime
6. Click WASTE to set waste volume or click WASTE OPEN DRAIN if waste is connected to
hospital waste cycle system.

7.Click PRIME ALL to prime all fluid path

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Start-up test
Back to main menu, click STARTUP to automatically rinse counting baths and perform a
background check. The STARTUP process takes around 5 mins.

Parameters Background Range

WBC < 0.2(103/µL)
RBC < 0.02 (106/µL)
HGB <0.2 g/dL
PLT < 10 (103/µL)

Caution: If start up fails, please repeat the

start up process until it is successful

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Repeatability test
Click STATS-REPEATABILITY, the sampling needle will move to the sampling position
automatically, use one fresh normal blood sample to test for 11 times continuously to
check the repeatability. ( leave out the first test result )

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Quality Control Test
Step 1: Navigate to STATS >> QC, then the quality control interface pops-up.

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Quality Control Test
Step 2: Select one of the listed items or generate a new lot, then navigate to CHANGE.

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Quality Control Test
Step 3: Input the targets and limits manually or click LOAD to load via an USB drive. Then
click to save the changes

* To load the target values via USB drive, one has to create a new directory: Main directory:
\H30\QC. The target values files shall be under this directory.

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Quality Control Test
Step 4: Navigate to RESULTS to go to test interface. (the sample needle will
move down in the meantime)

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Quality Control Test
Step 5: QC sample preparation.
1. Take the tubes from refrigerator and equilibrate it at room temperature (15℃～30℃ or 59°F～86 °F) for at least 15
minutes prior to mixing.
2. Hold a tube/vial between the palms of the hands for mixing. Don’t mix the product with a mechanical mixer.
a) Roll the tube back and forth for 20-30 seconds and occasionally invert the tube/vial. Mix it thoroughly but do not
shake.
b) Continue to mix in this manner until the red cells are completely suspended. Make sure there is no
sedimentation at the bottom of the tubes. Tubes stored for a long time may require extra mixing.
c) Gently invert the tube/vial 8-10 times immediately before running each sample.
3. Carefully wipe the cap of the tube with a lint-free tissue and replace the cap.
4. The QC shall be used within 14 days after it is open. Return tubes to refrigerator within 30 minutes of use.
5. Three levels ( L, N, H ) of QC test shall be passed.

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Quality Control Test
Step 6: Click on start key to aspirate QC sample and do the test.
Step 7: Check the QC test results, the warnings are shown as red fonts with H/L.
Step 8: Repeat the same procedures to test the other two levels QC.

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If Quality Control Test Failed
If QC failed, one shall follow the procedures below:

1. Make sure the QC has not expired either in open condition or packaged condition.
2. Make sure the QC re-warm procedure is properly done.
3. Make sure there is no hemolysis of QC.
4. Make sure the instrument itself is OK via doing repeatability test, if not OK, try to solve
the instrument failure via contact Edan service engineers.
5. If the repeatability test passes, try to use new bottle of QC. If the QC test fails again,
please try to do the same QC continuously for 3 times, if deviations are at the same
level, then one can do calibration.

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Calibration ( if needed)

If the QC failed, and the repeatability is OK, one shall do calibration on H30
There are three methods as listed below:

1. Manual calibration - Fresh blood (take HGB as an example)

2. Automatic calibration - Calibrator (all parameters calibrated once in a row)

3. Automatic calibration - Fresh blood (all parameters are calibrated once in a row)

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Calibration-Manual calibration ( if needed)
Step 1: Collect one fresh blood sample. ( storage time no more than 4 hours )
Step 2: Apply 5 to 7 measurements on the comparison analyzer and collect the average HGB value A.
Step 3: Apply same number of measurements on H30 analyzer and collect the average HGB value B.

Step 4: Obtain the previous HGB calibration factors by the following way:

Go to Service>>Settings>>Calibration factors and change the values

Login the system with account name: ADMIN, password: 123456.
shown here is old factors and it should be changed to new factors.

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Calibration - Manual calibration ( if needed)
Step 5: Obtain the new HGB calibration factors by the following way:

Apply the equation below to calculate the new HGB calibration factor.

𝑛𝑛𝑛𝑛𝑛𝑛 𝐻𝐻𝐻𝐻𝐻𝐻 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝐻𝐻𝐻𝐻𝐻𝐻 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓

=
𝐴𝐴 𝐵𝐵

Where A= Fresh blood test result on standard machine, B= Fresh blood test result on
H30.

Obtain the new HGB calibration factor and then replace the previous HGB calibration factor with
the new HGB calibration factor.

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Calibration - Manual calibration ( if needed)
e.g.

Reference method HGB average = 15.6 g/dL

H30 HGB average = 15.5 g/dL
Current HGB calibration factor is 1.000
1.000 x 15.6/15.5 = 1.007 (rounding off)

Therefore, new calibration factor of HGB should be set as 1.007. Calibration factor increased by
0.007

Step 6: Do QC on H30 as described previously. If the QC is still out of control, automatic

calibration(calibrators) is required to do calibration on H30.

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Calibration - Automatic calibration (with calibrator) ( if needed)
Step 1: Navigate to STATS>>CALIBRATION and enter calibration interface.
Step 2: Click CHANGE to input target values/limits or click LOAD to load via an USB drive

Step 3: Check the target value lists provided by EDAN.

Step 4: Then click to save the changes.
Target value Limits

* To load the target values via USB drive, one has to create a new directory: Main
directory: \H30\CALI. The target values files shall be under this directory.
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Calibration - Automatic calibration (with calibrator) ( if needed)
Step 5: Navigate to RESULTS to go to test interface.
Step 6: Press START KEY to aspirate calibrator, test for at least 7 times.
Caution: calibrator shall be used within 7 days after it is open, rewarm the calibrator for at
least 15 minutes at room temperature before doing test. Mix the calibrator thoroughly.

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Calibration - Automatic calibration (with calibrator) ( if needed)
Step 7: Click Calibrate and choose the desired parameters. Press and finish calibration.
Caution: If there is abnormal calibration result, please unselect this result then click calibrate.

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Calibrate Methods – Automatic calibration (with fresh blood)

One can use this method if the calibrator is not available and there are more than 3 parameters to calibrate.

Step 1: Collect one fresh blood sample. ( storage time no more than 4 hours )

Step 2: Apply 5 to 7 measurements on the comparison hematology analyzer and collect the average values of the
parameters that are out of control.

e.g. if you have five parameters that are out of control, collect the average values as follows:

Step 3: Use the average values as target values and go to the calibration screen to fill in the corresponding blanks.

e.g.

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Calibrate Methods – Automatic calibration (with fresh blood)

3. Input the
calculated average
values. In this
example, MPV is not
going to calibrate.
One can leave it like
that.

2. Input a valid 1. Click CHANGE

date to activate all
these changes.

4. The limits can

be calculated as
the method given
in the next page.

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Limits calculation

The limit is taken as 3 SD. The detailed calculation is as follows:

1. Take the standard deviation of the results. One can turn to the link below:

https://www.easycalculation.com/statistics/standard-deviation.php

2. The limit is then 3 times the standard deviation calculated in the first step.

e.g.

For WBC, the test results for 5 times on comparable hematology analyzer are: 10.5, 10.6, 10.3, 10.2, 10.5. Then
standard deviation is 0.16. ( use the link above ). Three times 0.16 is 0.48. One has to take half of this value to make
the limit. So, the limit for WBC is 0.24. Similar calculations can be applied on the other parameters.

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Calibrate Methods – Automatic calibration (with fresh blood)

Step 4: Navigate to RESULTS to go to test interface.

Step 5: Press START KEY to aspirate calibrator, test for at least 7 times.

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Calibrate Methods – Automatic calibration (with fresh blood)

Step 6: Click Calibrate and choose the desired parameters. Press and finish calibration.

Caution: If there are abnormal calibration results, please unselect these results then click calibrate. Unselect the parameters that
don’t need to calibrate.

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QC Verification(if needed)

After calibration process, one shall check QC again to make

sure the results are reliable. So, one shall go back to the QC
procedures as mentioned previously.

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Sample Test
Follow the steps below to perform whole blood sample test

Step 1: On the Main Screen,Press to go into the sample testing interface.

Step 2: Press to go into the following screen and edit patient sample information .

Step 3: After inputing patient information, press to save changes, then the system will return to previous screen and the sampling
needle will move to the sampling position automatically

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Sample Test
Step 4: Present the whole blood sample under the sample needle.

Step 5: Press the Start key located behind the sample needle and it will aspirate 9.6ul sample.

Step 6: Remove the sample device when the sample needle has risen up. Then the system will
automatically analyze the sample and display the test results on the current screen.

Step 7: On the result display interface, click TOOLS then select printer icon, the result will be
printed.

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 THANK YOU
Edan Instruments, Inc.
Tony Chen
www.edan.com.cn
imservice-ivd@edan.com.cn

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