Omron HEA-232 User manual

Blood Glucose Monitoring System
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Chapter 1 OMRON Blood Glucose Monitoring
System HEA-232
1.1 Introduction
1.2 List of Kit Contents
1.3 Product and Meter Display
Chapter 2 Installing and Setting up the
HEA-232
2.1 Inserting / replacing batteries
Chapter 3 Finger Blood Glucose Testing
3.1 Preparation before glucose testing
3.2 Fingertip blood measurement
Chapter 4 Glucose Control Solution Testing
(Optional)
4.1 Control test
Chapter 5 Memory Function
5.1 Reviewing past results
Chapter 6 Instructions on Caring and Storing
for Your Strips and Meter
6.1 Caring for the strip
6.2 Caring for the meter
Chapter 7 Troubleshooting
Chapter 8 HEA-232 Performance
Characteristics
Chapter 9 Specication
Contents
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IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this
manual.
2. Do NOT use accessories which are not specified by the
manufacturer.
3. Do NOT use the device if it is not working properly or if it is
damaged.
4. Do NOT use the equipment in places where aerosol sprays
are being used or where oxygen is being administered.
5. Do NOT use under any circumstances use the device on
neonates or infants.
6. This device does NOT serve as a cure for any symptoms
or diseases. The data measured is for reference only. User
should not take any decision of medical relevance without
first consultation of medical practitioner. Always consult your
doctor to have the results interpreted.
7. Before using this device to test blood glucose, read all
instructions thoroughly and practice the test. Carry out all the
quality control checks as directed.
8 Use this instrument in a dry environment, if synthetic materials
are present (synthetic clothing, carpets etc.) it may cause
damaging static discharges that may cause erroneous results.
9. Do not use this instrument in close proximity to sources of
strong electromagnetic radiation, as these may interfere with
the accurate operation.
10. Do not use this meter near cellular or cordless telephones,
walkie talkies, garge door openers, radio transmitter, or
other electrical or electronical equipment that are sources
of electromagnetic radiation, as these may interfere with the
proper operation of the meter.
11. The device for self-testing is used for the monitoring of an
existing disease (eg., diabetes) the patient should only adapt
the treatment if he has received the appropriate training to
do so.
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Chapter 1 OMRON Blood Glucose Monitoring
System HEA-232
1.1 Introduction
The HEA-232 uses state-of-art bioelectrochemistry detecting
technology; it needs approximately 1μL of fresh capillary whole
blood for one test. The blood glucose concentration is displayed in 5
seconds after the blood has been applied to the test zone. The device
is intended for use by diabetics to monitor their own glucose levels.
Please read the instruction manual carefully before using. Hea-232 is
an in vitro diagnostic medical device for self-testing. Capillary action
automatically lls the reaction zone with the test sample from the front
channel. The device should not be used for screening or diagnosis of
diabetes or for testing on neonates.
Intended Use
The HEA-232 is an in-vitro diagnostic medical device intended for the
quantitative measurement of glucose in fresh capillary whole blood
samples drawn from the ngertips. Testing is done outside the body.
It is designed for self-testing to monitor the effectiveness of diabetes
control. The device should not be used for screening or diagnosis of
diabetes or for testing neonates.
Principle of the method
The auto-filling process precisely controls the sample volume. The
blood glucose test strip is a kind of electrochemical sensor. When the
blood sample reacts with the strip, the glucose meter displays a reading
that depends on the number of electrons detected as a result of the
reaction.
The current generated by the reaction on the test strip is used to
calculate the glucose concentration of the sample which is then
displayed by the device.
Warning: The Glucose Results provided by HEA-232 is only for
reference; never make significant changes in your diabetes
treatment program without consulting a doctor.
Warning: Evaluations using the HEA-232 by lay persons in
different countries will depend on their uency, or otherwise, in the
understanding and the assessment of ease of use and interpretation
of the results.
Measuring principle
Amperometric biosensors are quite sensitive and more suited for mass
production. The working electrode of the amperometric biosensor
is usually a screen-printed layer covered by the bio-recognition
component. The dried reagent was applied on a pair of carbon
electrodes. Glucose can be specically catalyzed by the enzyme, and
then the reaction current can be measured according to the glucose
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Strip Port- Insert Strip Here
Button- Turn / off meter
Query test record
Meter Display
Battery Cover
levels of the test sample by electronic devices. HEA-232 utilizes
electrochemical biosensing technology (Amperometric biosensor) to
measure the glucose level in fresh capillary whole blood. At the applied
potential after blood draw into the reaction zone of strips, conversion
of electroactive species generated in the enzyme layer occurs at the
electrode and the resulting current is measured by HEA-232 .
1.2 List of Kit Contents
1. Blood Glucose Meter
2. Sterile Lancets
3. Lancing device
4. Instructions for the lancing device
5. Carrying Case
6. Instruction Manual
7. Log Book
8. CR2032 Battery
1.3 Product and Meter Display
A. HEA-232 Blood Glucose Meter Display
Caution:The HEA-232 meter measurement unit was set as mg/dL
or mmol/L from manufacturer side. the unit exchange ratio is as the
followings: 1 mmol / L = 18.02 mg/dL
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B. HEA-STP30 Glucose Test Strip
C. Function Display
Battery
mg/dL mmol/L
Test Unit Temperature
Error Message Test Result
Battery
Error Message
Test Unit
Test Result Temperature
Top Edge- Apply blood
sample here.
Inserting Bar- Insert this test strip
port with this side facing up.
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a. Open battery compartment
c. Reinstall battery cover
b. Place a new battery inside
Chapter 2 Installing and Setting up the HEA-232
2.1 Inserting / replacing batteries
When should users change the batteries?
If the battery power is too low to perform a test, the and error
symbol will appear on the display after the device is powered on. In
this case, the system will shut down automatically after 120 seconds.
The battery will have to be replaced before the HEA-232 can be used.
However previously recorded results will not be lost.
There are two conditions which might occur depending on battery
power status
1. The battery power is low:
However, you can still use HEA-232 and results will still be accurate,
but we still strongly suggest you replace the batteries as soon as
possible.
2. The battery symbol ashes on the display after powering on:
The system will shut down automatically after 120 seconds when
only the battery symbol ashes on the display after powering on. It
means the battery power is too low to perform a measurement. You
have to replace the battery in order to continue using the HEA-232;
past results remain recorded.
How to replace HEA-232’s batteries
1. Turn HEA-232 meter over and open the battery cover.
2. Replace one CR-2032 battery with the (+) sign side of battery facing
up.
3. Insert battery cover back to the battery compartment until a
“click”sound is heard.
4. Turn on the device to see whether the HEA-232 is powered on. If
not, please re-examine battery replacing procedures.
5. Please dispose of used batteries according to local regulations.
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Adjustable tip Carrier Trigger Barrel
Cap Ejector
c. Twist the protective cap of lancet d. Remove the cap if lancing
device and adjust the puncture
depth
a. Remove the cap by twisting it b. Install the lancet
Chapter 3 Finger Blood Glucose Testing
3.1 Preparation before glucose testing
Please prepare materials you need as listed below and read this
manual to ensure the correct measuring process and results.
□ Blood Glucose Meter.
□ Blood Glucose Test Strip.
□ Lancing Device.
□ Lancet
3.2 Fingertip blood measurement
A. Install the Lancet
Check if lancet is new before installing it to the lancet holder and
ensure it is fully seated. Then remove the protective cap.
Adjust the puncture depth by selection dial (normally at 2nd level), twist
to suitable number (smaller number for a shallower puncture and a
larger number for a deeper puncture depth).
Structure:
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Do not insert the strip from reverse side
Insert the test strip (Correctly)
B. Cock the sampler
Slide the barrel control back until it clicks. The lancing device is now
ready for use.
Warning
• Always use a new lancet.
• Do not use the same lancet to obtain blood samples from different
people.
• Please refer to instruction of lancing device for detail description
and proper use.
C. Wash your hands and the puncture site
Wash hands with soap and warm water. Rinse and dry thoroughly.
D. Preparation of strip
1. Insert strip correctly
Take a new blood glucose test strip from the vial and insert it
into the meter correctly as the following.
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The meter will automatically start and show the last result data; if no
data, it will show the following.
Caution:The HEA-232 meter measurement unit was set as mg/dL
or mmol/L from manufacturer side. the unit exchange ratio is as the
followings: 1 mmol / L = 18.02 mg/dL
2. Setting up strip code
Please check the code number showed on the display is same as the
code number printed on the strip bottle;
If they are not same, alter the code number within 5 seconds.
Press and hold the button to increase the code number quickly.
The biggest code number is “99”. When the code number is over
“99”, it will be back to “1”, and keep increasing:
If press the button and release shortly, the code number will only
increae by one.
88
Code
mg/dL
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3. Ready to test
When you set the correct code number, please wait for 5
seconds, and the meter will display with symbol. And then
please apply blood sample within 2 minutes.
E. Fingertip blood sampling
Please massage your fingertip gently to help you obtain blood.
We suggest that you puncture a different area each time.
Repeated punctures in the same area may cause soreness. The
blood sample required is only 1μL, do not squeeze excessively
at the puncture area.
The HEA-232 will display the code number on the screen
when waiting for the blood to drop in, the user needs to
make sure the code number is the same as that of the strip
container.
F. Blood glucose measurement
Hold the lancing device firmly against the side of your fingertip.
Press release button; gently squeeze your finger to assist the
flow of blood.
Apply a drop of blood to the tip of the reaction zone of the test
strip after the blood drop symbol flashes on the meter display.
You will hear “beep” and the meter will start to count down. The
test result will appear on the display after the meter counts down
from 5 to 1 (5 seconds). The meter will turn off automatically
after the test strip is removed. Place the used strip in a suitable
container for proper disposal.
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Sample lled Sample too small
Caution:The HEA-232 measurement unit was set as mg/dL or
mmol/L from manufacturer side.
Caution: Do not smear blood on the strip.
Touch the blood drop of fingertip to the reaction zone.
The following items will cause inaccurate results:
□ The reaction zone does not fill completely.
□ Applying blood more than once.
□ Not applying blood to a test strip after a period of time.
□ Variation in environment when measuring.
□ Using a false test strip.
G. Strip removal
Pull up the strip carefully to avoid touching the blood.
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H. Blood glucose value display:
The blood glucose test will be performed in 5 seconds when the
blood drops into the test strip. The test result will automatically
be stored in the meter memory.
◆
Please dispose of used test strip and lancet in a sealed
container to avoid environmental pollution.
Important:
□ Do not use a single test strip more than once.
□ It should not be used for testing newborns.
□ It should be used only for testing fresh capillary whole blood
samples drawn from the fingertips only.
□ It should not be used for venous whole blood or plasma.
□ A red blood cell count (hematocrit) that is higher than 55%
or lower than 30% may cause false test results.
Chapter 4: Glucose Control Solution Testing
(Optional)
4.1 Control test
In order to provide you a precise blood glucose value, we suggest the
user to run a control test to let you know if the meter and test strips
are working properly or not. When the result is within the range of the
control solution value written on the test strip vial, the test strips and
meter are working properly.
When to run the glucose control solution test:
 You thin your test strips have been damaged.
 Test result is not compatible with how you feel..
 You thin your glucose meter could be broen.
If you will like to perform control solution test or have any
question, please contact your local authorized distributor for
more information.
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Important:
• Use only the OMRON glucose control solution HEA-CTR30 with HEA-232
meter and HEA-STP30 strips.
• Mar the newly opened bottle of control solution with the date opened; discard
any unnished control solution over three months after opening.
• Store control solution at room temperature. Do not freeze.
• Shae control solution before you use it. Please replace new control solution if
the control solution deteriorate or coagulate.
* Before running the test, place the meter, test strips and glucose control
solution at room temperature to reach the new temperature before use.
A. Prepare for the HEA-232 and test strip
Insert the test strip into the meter. The meter will display the code number.
Make sure the code number on the display matches the code number on
the test strip vial. (Refer to Chapter 3 Fingertip blood measurement for more
information)
When the HEA-232 is ready to apply blood sample, press button twice to
enter control solution test mode. The “Blood” symbol will disappear in the
control solution test mode.
In the control solution test mode, the test result will not be recorded.
B. Prepare for the control solution
Before using the control solution, gently shake the control bottle to ensure it is mixed well.
Remove the control bottle cap and wipe the tip of the bottle with a tissue. Squeeze the
bottle until a tiny drop forms at the tip of the bottle and drop on a clean surface.
C. Run the control solution test
Touch the tip of the test strip to the drop of control solution. The control solution test result
will show on display after 5 seconds count down. The HEA-232 will automatically power
off after the test strip is removed. Discard the used test strip in accordance with local
regulations.
Finger tip blood test mode Control solution test mode
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D. Understanding control test results
When the control solution test result is inside the range on the
printed on the test strip vial, then the HEA-232 and test strips
are working properly.
Caution:The HEA-232 meter measurement unit was set as mg/dL or mmol/L from
manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = 18.02 mg/dL
If the control solution test result is not within the specied range printed on your test strip vial,
please repeat the control solution test again. If the result continues to fall out of the specied
range, here are some points that need to be checked:
• Did you follow all of the testing instructions?
• Are the test strips or control solution expired?
• Is HEA-232 defective in material or workmanship?
• Does the code number of the meter matches the code number on the test strip vial?
Repeat the control solution test with a new test strip. If you still have problems, please contact
your local authorized OMRON distributor for more information.
Chapter 5 Memory Function
5.1 Reviewing past results
◆ Press button to turn on the HEA-232, the display will show the most recent test
result then the index and then the most recent test result after a 1 second delay.
Press the button again to display the second recent test result; every time the
button is pressed, it will display a previous result. After the 14th result, it will return
to the rst. HEA-232 is able to store up to 14 test results.
Control Solution Range
120 - 150 mg/dL
6.6 - 8.3 mmol/L
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 Then you can press the button to review previous test results.
Caution:The HEA-232 meter measurement unit was set as mg/dL or mmol/L from
manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = 18.02 mg/dL
After 1 second After 2 seconds
After 1 second After 2 seconds
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Chapter 6 Instructions on Caring and Storing
for Your Strips and Meter
6.1 Caring for the strip
• Wash hands before testing.
• Do not use a strip that has expired. Check the expiration date printed
on the package.
• When you rst open the test strip bottle, record the day you opened
it on the label of the bottle. Discard the bottle and any remaining test
strips after 90 days from the opening date.
• Keep the strip bottle away from direct sunlight and heat, and store
at ambient temperature between 4℃-30℃(39 ℉~86 ℉). Do not
refrigerate.
• The strip bottle should be stored in a dry place at room temperature.
• Do not put the test strip into other containers.
• Always close the container tightly immediately after taking a test strip
out.
• Keep the test strip from getting dirty or polluted during storage.
• Discard the control solution of bottle after 90 days from the opening
date.
• Glucose control solution: Discard the bottle 3 months after the
opening date.
6.2 Caring for the meter
• If the meter’s surface gets dirty, gently wipe it with a slightly dampened cloth
used with mild detergent.
• Medical staff may use 10% bleach, 70% alcohol (ethanol), or 10% ammonia
scouring reagent.
• Do not clean the test strip slot.
• Do not allow any liquid to enter the test strip slot or the button of the meter.
• Do not put the meter under water or any liquid.
• The meter must be stored at room temperature
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Chapter 7 Troubleshooting
When the meter is used incorrectly, or other unexpected events occur,
the screen will show an error message to remind the user to notice the
problems and/or how to resolve them.
The following messages mean you may have obtained a result that
requires immediate attention or there may be a problem with the meter:
Message Symbol Mean Action
HI
Blood glucose may be
higher than the measuring
range of the system
( > 600 mg/dL; 33.3
mmol/L )
Although this message
could be due to a test
error, it is safer to treat rst
and then do another test.
1. Do control solution test.
2. Redo your glucose test.
3. Contact your healthcare
professionals.
LO
Blood glucose may be
lower than the measuring
range of the system
(< 20 mg/dL; 1.1 mmol/L)
Although this message
could be due to a test
error, it is safer to treat rst
and then do another test.
1. Do control solution test.
2. Redo your glucose test.
3. Contact your healthcare
professionals.
Temperature
symbol
continuously
ash
You may have tested
in an environment near
the low or high end of
the system's operating
temperature range.
(10℃-40℃/50 ℉-
104 ℉)
Repeat the test after the
meter has reached a
temperature within the
operating range.
Battery symbol
continuously
ash
The power is too low to
perform a test. Replace the battery.
Wrong Test
Strip
Test strip is over
expiration date, broken,
or used again.
Use other new HEA-
STP30 Test Strip.
Wrong Blood
Enter Timing
Obtain blood sample too
soon. Follow instruction step.
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Chapter 8 HEA-232 Performance
Characteristics
Traceability:
The HEA-232 test result were calibrated to YSI readings. The
YSI analyzer was calibrated using a standard solution(180mg/
dL(10mmol/L) which can be traced to NIST SRM #917A.
Accuracy:
The results from the HEA-232 were compared with those from
YSI glucose analyzer. The study showed the HEA-232 results
were consistent with the YSI readings. The following results were
obtained from 115 subjects at 2 clinic centers.
Slope 1 1.0722
y-intercept -6.2869mg/dL (-0.4mmol/L)
Correlation factor (R2) 0.9733
Patient number (n) 230
Test range 22~537mg/dL (1.2~29.8mmol/L)
Number and % of results within reference (for values were ＜75 mg/dL)
Within ± 5 mg/dL
(0.3mmol/L)
Within ± 10 mg/dL
(0.6mmol/L)
Within ± 15 mg/dL
(0.8mmol/L)
10/32 (31.3 %) 26/32 (81.3 %) 32/32 (100 %)
Number and % of results within reference (for values were ≧ 75 mg/dL)
Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 %
104/198 (52.5 %) 149/198 (75.3 %) 177/198 (89.4 %) 194/198 (98.0 %)
When sample concentration < 75mg/dL(4.2mmol/L): 100% data fall within
± 15mg/dL(0.8mmol/L) with reference.
When sample concentration ≧ 75mg/dL(4.2mmol/L): 98% data fall within ±
20% to reference.
Precision:
This study shows a variability from strip to strip in sample tests. The results
are shown in the following table.
Within Run Precision
Samples Mean glucose concentration measured CV
Sample 1 32.9 mg/dL (1.8mmol/L) SD=1.8 mg/dL(0.1mmol/L)
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