H30 QC and Calibration SOP v1.1

In-vitro Diagnostics
H30 Support document
2 ©2018 EDAN Confidential

H30 QC and Calibration SOP
EDAN Instruments, Inc.

Neo WANG
www.edan.com.cn
imservice-ivd@edan.com.cn
2018.06.07
Outline
1. Overview
2. Quality control procedures
3. QC failed
4. Calibrate Methods
5. QC verification
A, Click to edit Master text styles

Overview
Quality control shall be applied everyday.
1. If QC passed, indicating the instrument is at a good condition. So, there

is no need to do calibration.
2. If QC failed ( the QC results background is red ), then calibration is

needed.
Calibration method:
Finding another hematology instrument as comparison instrument and perform

calibration on H30 with fresh blood or use calibrator. After which, perform QC
test again to verify if the H30 is in control.
A, Click to edit Master text styles

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

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

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.

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

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.

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.

QC failed
If QC failed, one shall check if the issue comes from QC itself or

equipment by following 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.
Calibrate Methods
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 are calibrated once in a row)
3. Automatic calibration - Fresh blood (all parameters are calibrated once in a row)
*If the room temperature changes more than 10°C during the working day, the analyzer must be calibrated.

Calibrate Methods – Manual calibration
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 HGB value A.
Step 3: Apply same number of measurements on H30 hematology analyzer and collect the average HGB value B.
Step 4: Obtain the previous HGB calibration factors by the following way:
Login the system with account name: ADMIN, password: 123456. Go to Service>>Settings>>Calibration factors and the values shown
here is old factors and it should be changed to new factors.
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.

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.

Calibrate Methods – Automatic calibration (with calibrator)
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.

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

Step 7: 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.

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.

3. Input the calculated
average values. In this
example, MPV is not
going to calibrate.
One can leave it like
that.
1. Click CHANGE
to activate all these
2. Input a valid
changes.
date
4. The limits can be

calculated as the
method given in the
next page.

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 value. So, the limit for WBC is 0.24. Similar calculations can be applied on the other parameters.

Step 4: Navigate to RESULTS to go to test interface.
Step 5: Press START KEY to aspirate calibrator, test for at least 7 times.

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.

QC verification
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.

THANK YOU
Edan Instruments, Inc.
Neo.Wang
www.edan.com.cn
imservice-ivd@edan.com.cn
06.09.2018

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In-vitro Diagnostics

H30 Support document

2 ©2018 EDAN Confidential

2 ©2018 EDAN Confidential

EDAN Instruments, Inc.

2. Quality control procedures

A, Click to edit Master text styles

Quality control shall be applied everyday.

1. If QC passed, indicating the instrument is at a good condition. So, there

2. If QC failed ( the QC results background is red ), then calibration is

Finding another hematology instrument as comparison instrument and perform

A, Click to edit Master text styles

6 ©2018 EDAN Confidential

7 ©2018 EDAN Confidential

8 ©2018 EDAN Confidential

9 ©2018 EDAN Confidential

5. Three levels ( L,N,H ) of QC test shall be passed.

10 ©2018 EDAN Confidential

11 ©2018 EDAN Confidential

If QC failed, one shall check if the issue comes from QC itself or

2. Make sure the QC re-warm procedure is properly done.

3. Make sure there is no hemolysis of QC.

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

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

13 ©2018 EDAN Confidential

15 ©2018 EDAN Confidential

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)

16 ©2018 EDAN Confidential

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

18 ©2018 EDAN Confidential

19 ©2018 EDAN Confidential

20 ©2018 EDAN Confidential

4. The limits can be

21 ©2018 EDAN Confidential

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

22 ©2018 EDAN Confidential

23 ©2018 EDAN Confidential

24 ©2018 EDAN Confidential

After calibration process, one shall check QC again to make

25 ©2018 EDAN Confidential

26 ©2018 EDAN Confidential

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