Omron HEA-230 User Manual

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Blood Glucose Monitoring System

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Contents

Chapter 1 Blood Glucose Monitoring System

1.1 Introduction

1.2 List of kit contents

1.3 Product and meter display

Chapter 2 Installing and Setting up the Meter

2.1 Inserting / replacing batteries

2.2 Setting up your meter

2.3 Performing a blood glucose measurement

Chapter 3 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-230 Performance

Characteristics

Chapter 9 Specication and Maintenance

3
4
4

6
7

10

12
13

17

20

23
23

24

25

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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 Blood Glucose Monitoring System

1.1 Introduction

The blood glucose monitoring system, model HEA-230 uses the state-of­art bio-electrochemistry detecting technology, it only needs approximately

1 μL fresh capillary blood for one testing. Blood glucose concentration

result will be showed in 5 seconds after you apply a blood sample into
the test zone. It could help diabetics monitoring their glucose level, and
is intended for blood glucose monitoring by people with diabetics and
healthcare professionals. Please read instruction manual carefully before
using.

HEA-230 is an in vitro diagnostic medical device for self-testing. By

capillary action, test sample will automatically ll up the reaction zone by

inhalation from the front channel.

Intended Use

The Blood Glucose Monitoring System, model HEA-230, 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

Principle of the method

By auto-filled mechanism, the volume of the sample can be precisely
controlled. The blood glucose test strip is a kind of electrochemical
biosensor. When the blood sample reacts with the strip, the glucose
meter provides a voltage and the number of electrons produced by the
reaction is detected.The current obtained from the blood glucose meter
can be calculated by the internal conversion formula and be translated to
the concentration of the sample.

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Warning: The glucose results provided by this system are only for

the reference; never make signicant changes in your diabetes treatment

program without consulting physicians.

3

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. 2 x AAA Batteries

1.3 Product and meter display

A. Meter appearance

Test port

-Insert test strip
here

Meter disply

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Left Button

-Setting

Data port

Caution: The measurement unit either mg/dL or mmol/L is xed

in the meter according to the country demand. You are not able
to change the unit in the meter. The unit exchange ratio is as the
followings: 1 mmol / L = 18.02 mg/dL.

Right Button

-Power on & off

B. Strip appearance

C. Function display

Top Edge

-Apply blood sample here.

Inserting Bar

-Insert this test strip into the
meters’ strip port with this side
facing up.

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5

Chapter 2 Installing and Setting up the Meter

2.1 Inserting / replacing batteries

◆

When to change the batteries

When the battery sign appears on the display

,the battery power is low and replacing the batter as soon
as possible is required for the meter.

◆

There are two conditions might occur depending on

battery power status

1. When the battery sign flashes on the display after

powered on, it represent the power of the batteries
are low. However, you can still perform glucose
measurements and the results will still be accurate, but
it is recommended replacing the batteries as soon as
possible.

2. The meter will shut down automatically after 120 seconds

when only battery sign flashing on the display after
powered on. It represents the battery power is too low
to perform a measurement. You have to replace the
batteries in order to continue using this meter.Time and
date is required to be reset after replacing the batteries,
however the past results is still recorded.

◆

How to replace batteries for Meter

1. Turn meter to the back side and open the battery

compartment.

2. Replace two new AAA batteries and please take notice of

(+) and (-) signs.

3. Install battery cover back to the battery compartment

until hearing a “click” sound.

4. Try to turn on the device to see whether the meter is

powered on. If not, please reexamine batteryies replacing
procedures.

5. After turning on the meter, it will enter into time and date

setting mode directly. (Please refer to setting up your
meter of 2.2 for relative settings.)

6. Please dispose the used batteries according to the

regulation.

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a. open battery cover b. place new batteries c. install battery

2.2 Setting up your meter

cover back
to the battery
compartment

1. Setting the date

◆

How to enter the date setting mode

Press right button to turn on. The display will show the most
recent test result. Press and hold down the left button until
data sign stop flashing. Then press right button three times
to display the date. To enter the date setting mode, press
and hold down the left button until calendar sign flashes.

◆

How to set up the date

Setting year
Once you entered the date setting mode, the last two digits

of the year will flash.
(1) Press the right button once to increase a year.
(2) Press the left button once to decrease a year.
(3) Then press and hold down the left button to save your

year. The display will now enter the month setting mode.

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7

Setting month
Once you enter the month setting mode, the month field will

flash.
(1) Press the right button once to increase a month
(2) Press the left button once to decrease a month
(3) Then press and hold down the left button to save your

month. The display will now enter the date setting mode.

Setting date
Once you enter the day setting mode, the day field will

flash.
(1) Press the right button once to increase a day
(2) Press the left button once to decrease a day
(3) Then press and hold down the left button to save your

setting. The display will now show your new setting

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2. Setting the time

◆

How to enter the time setting mode

Press right button to turn on. The display will show the most
recent test result. Press and hold down the left button until
data sign stop flashing. Then press right button four times
to display the time. To enter the time setting mode, press
and hold down the left button until time sign flashes.

◆

How to set up the time
Setting Hour
Once you entered the time setting mode, the hour field will

flash. The time display is by 12 hour-format, AM is before
noon and, PM is afternoon or by 24 hour-format.

(1) Press the right button once to increase an hour
(2) Press the left button once to decrease an hour
(3) Then press and hold down the left button to save your

setting. The display will now enter the minutes setting
mode.

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Setting Minute
Once you entered the minutes setting mode, the minute

field flashes
(1) Press the right button once to increase a minute.
(2) Press the left button once to decrease a minute.
(3) Then press and hold down the left button to save your

setting. The display will now show the time of your new
setting.

2.3 Performing a blood glucose measurement

1. Inserting a test strip

After inserting the test strip, the meter will turn on
automatically and all icons on the display will appear for
1 second. Then the display will show the most recent test
result. (For first time use or after battery changing, it will
enter into setting mode directly)

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2. Entering the code number
The display will now show a locker sign and previous selected code

number.
Press the right or left buttons to increase or decrease the code

number. Adjust the code number on display to match the code
number on the test strip vial, then wait for 5 seconds to enter next
screen display.

3. Applying blood
After entering the code number, apply blood sign will appear on

display. Gently touch the blood drop to the tip of the test strip within
2 minutes, then glucose level will show on the display after

sign ashing for 5 seconds.If the warning sign appears, please see

chapter 8.

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11

4. Measuring blood glucose concentration

After the blood glucose measurement,
can also press left or right button to review past results or hold down

sign ashes. Then you

the left button to quit this mode.

Caution: The measurement unit either mg/dL or mmol/L is xed in the

meter according to the country demand. You are not able to change the
unit in the meter. The unit exchange ratio is as the followings: 1 mmol / L =

18.02 mg/dL.

Chapter 3 Glucose Testing

3.1 Preparation before glucose testing

Please prepare materials you need as listed below, and read this manual
carefully, to ensure the correct measuring process and results.

● blood glucose meter, model HEA-230

● blood glucose test strip, model HEA-STP30

● Lancing device

● Lancet

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3.2 Fingertip blood measurement

Appearance of the lancing device:

Ejector

Adjustable tip Carrier Trigger Barrel

A. Install the lancet
Check if you use a new lancet or not; unscrew the tip of lancing

device; install the lancet into the lancet holder correctly and make
sure it is fully seated, then remove the protective cap.

Adjust the puncture depth by selection dial, please twist case to
suitable number. (The smaller number for the shallower puncture, and
the larger number for the deeper puncture.)

a. Twist the cap to remove it. b. Install the lancet.

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c. Twist the protective cap
from lancet.

d. Install the tip of lancing

device and adjust the
puncture depth.

13

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.

C. Wash your hand and the puncture site
Wash hand with soap and warm water. Rinse and dry thoroughly.

D. Fingertip blood sampling

Please massage your nger tip gently and it will help you to obtain

blood smoothly. We suggest that you could puncture different
area each time. Repeated punctures in the same area may cause
soreness. The blood sample for OMRON blood glucose test strip ,

model HEA-STP30, is just need approximately 1μL. Do not squeeze

excessively at puncture area.

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E. Preparation of test strip
To get a new blood glucose test strip from vial, then insert test strip

into the meter. The strip code number will appear on meter display,
check the code number on strip vial. If it does not match, please
select the correct code number according to chapter 2.3. The symbol

of blood drop with nger symbol will appear after selecting.

Warning :To protect test strips from exposure to air, please press the

cap of the vial till it “clicks”.

F. Blood glucose measurement

Hold the lancing device rmly against the side o f your ngertip. Press

the release button, gently squeeze your finger to assist the flow of
blood. Touch the blood drop to the tip of the reaction zone of test strip

after the symbol of blood drop ashes on the meter display. The test

result will appear on display after the meter counts down from 5 to 1
(5 seconds).

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Touch the blood drop of ngertip to the reaction zone.

15

Sample filled

Sample too small

The following items will cause inaccurate results:

• The reaction zone does not ll completely

• Apply blood over once.

• Do not apply blood to test strip after a period of time.

• Avoid violent variation of environment when you measure.

• Using a false test strip.

G. Blood glucose value display
The blood glucose test will perform in 5 seconds when
the blood drop is drawn into the test strip. The test result
will automatically be stored in the meter memory.
* Please dispose of used test strip and lancet to a sealed container to

avoid environment pollution.

Important:

• Do not use single use test strip more than once.

• It should not be used for testing arterial, venous, or neonatal

blood.

• It should be used for testing fresh capillary whole blood only.

• It should not be used for plasma.

• If red blood cell count (hematocrit) is higher than 55% or lower than
30%, it can cause false test results.

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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 think your test strips have been damaged.

• Test result is not compatible with how you feel..

• You think your glucose meter could be broken.

If you will like to perform control solution test or have any question,
please contact your local authorized distributor for more information.

Important:

•Use only the OMRON glucose control solution HEA-CTR30 with HEA-

230 meter and HEA-STP30 strips.

•Mark the newly opened bottle of control solution with the date

opened; discard any unfinished control solution over three months
after opening.

•Store control solution at room temperature. Do not freeze.

•Shake 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.

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17

◆

The step of running control test:

1. Preparing a test strip

Take a test strip from strip vial and insert the test strip into the meter
correctly in the front direction of the meter, in the meantime, the meter
will display the code number. Make sure the code number on the
display matches the code number on the test strip vial. If it does not
match, please set the code number on screen to match the strip vial.

When the screen shows a symbol of nger tip and drop blood, press

the left button to enter glucose control solution test mode. After the
symbol of finger tip disappears, system enters the glucose control
solution test mode. In the glucose control solution testing mode, the
results are not recorded in historical memory.

HEA-230

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Fingertip blood test mode
glucose control solution test

mode

Press the left button to enter

2. Running the glucose control solution test

Before running the glucose control solution test, always check the
expiration date. DO NOT use control solutions if expired. Before
using the control solution, gently shake the solution bottle to make
the solution well mixed. Remove the 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. Put this drop on the clean surface. Touch the
drop of control solution to the tip of the reaction zone of the test strip.
accordance with local regulations.

Write the date you rst open the bottle on the bottle label. The control

solution must be discarded over three months from the date the
bottle was opened (“discard” date) or on the “expired” date on the

bottle label, whichever comes rst. Do not use control solution that is

“expired” or after discard date.

3. Understanding control test results

When the control solution result is within the range on the test strip

vial, the test strips and meter are working properly.

If the result is not within the acceptable range (printed on your test
strip vial), do not use your meter until you solve the problem. Repeat
the control solution test again. If the result continues to be outside of
the expected range, here are some things you can check:

•Did you follow all of the testing instructions?

•Are the test strips or control solution past the “expired” date or
discard date?

•Is HEA-230 meter defective in material or workmanship?

•Does the code number on the meter display match the code number
on the test strip vial?

Repeat the control test with a new test strip. If you still have problems,
please contact your local authorized distributor for more information.

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Chapter 5 Memory Function

5.1 Reviewing past results

* The code number will not show on the display when reviewing the

past results.

1. Checking single result

Press right button to turn on the HEA-230 System, then

◆

all icons will appear on the display for 1 seconds. After
the sign flashes

the most recent test result

Then you can press left button to review previous test

◆

results. (In this mode, time and date display alternately.)

and the display will show second

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HEA-230 system is able to store up to 512 test results

◆

together with date and time.

2. Average the results

How to enter the result averaging mode

◆

Press right button to turn on the HEA-230 system, then

all segments will appear on the display for 1 second.
The

sign will appear and the display will show the
most recent test result. Press and hold down left key will
display the most test recent result.

Press right button once to display result averaging sign.

How to check average Information

◆

□ Press and hold down the left button to enter result

average mode, then result averaging sign

flashes.

□ Press left or right button to calculate the average result

based on the test results stored for the past 7, 14 or 28
days.

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21

Press and hold down left button to exit result averaging

mode, then the display will return to the past 7 day
average screen.

How to read average measurement

◆

Average information displays the current day selection

for average, how many test results being recorded and
glucose unit.

When test result exceeds 99 records, It will represent.

22

Average by day

Number of records

Average test result

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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 the expired strip.
□ Check the expired date printed on the package.
□ Record the opened day on the test strip bottle label

when you first open it.

□ Discard the bottle and any remaining test strips after 90

days.

□ Keep the strip vial away from direct sunlight and high

heat.

□ Store the test strips at ambient temperature between

4℃~30℃(39℉~86℉).

□ Do not refrigerate.
□ Humidity should be below 75% RH.
□ The strip vial should be stored in a dry place.
□ Do not put the test strip into other containers.
□ Always close strip vial tightly after taking a test strip out.
□ Keep the test strip from getting dirty or polluted during

the storage.

6.2 Caring for the meter

□ If the meter’s surface gets dirty, gently wipe it with a cloth

slightly dampened or one with mild detergent.

□ For those medical staff, you may use 10% bleach, 70%

alcohol(ethanol), or 10% ammonia scouring reagent.

□ Do not clean the test strip slot.
□ Do not get any liquid into the test strip slot or on 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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23

Chapter 7 Troubleshooting

When the meter is used incorrectly, in poor condition, or other
unexpected events happen, the screen will show the error message to
remind the user should notice the problems or how to resolve them.

The following messages may mean you have obtained a result that
requires immediate attention or there may be a problem with the meter.
If the result appears to be questionable to you, please contact contact
your distributor.

Message Symbol Means Action

Recheck your
glucose level
and contact
your healthcare
professionals

Recheck your
glucose level
and contact
your healthcare
professionals

Repeat the test
after the meter
have reached
a temperature
within the
operating range

Replace the
battery at once

Use other new
Premium test
strip

Follow
instruction step

Reinstall the
battery or
change battery

HI

LO

Temperature
symbol
continuously

ash

Battery symbol
continuously

ash

Wrong test strip

Wrong blood
enter timing

Display freezes
over two minutes
or button can't
be operated

You may have a very high
blood glucose level
( >33.3 mmol/L, 600 mg/dL)

You may have a very low
blood glucose level
( <1.1 mmol/L, 20 mg/dL)

You may have tested in an
environment near the low
or high end of the system’s
operating temperature range
(10℃-40℃/50℉-104℉)

The power is too low to
perform a test

Test strip is over expiration
data, broken, or used again.

Obtain blood sample too
soon

Reset the meter system

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Chapter 8 HEA-230 Performance Characteristics

The test result of Premium glucose monitoring system is plasma
calibrated by chemistry analyzer, and the analyzer was calibrated with a
NIST traceable glucose standard solution.

Measurement range:

The HEA-230 display results between 20 and 600 mg/dL (1.1 ~ 33.3
mmol/L).

Accuracy:

The accuracy of the HEA-230 was assessed by comparing blood
glucose results obtained by patients with those obtained using clinical
analyzer. The following results were obtained 120 subjectsat at 2 clinical
centers.

Slope 1.0384
y-intercept 1.6664 mg/dL (0.0925 mmol/L)
Correlation factor (n) 0.9827
Patient number (n) 240
Test range 40~443 mg/dL (2.2~24.6 mmol/L)

Number and % of results within reference (for values were ＜ 75 mg/

dL(4.2 mmol/L))

Within ± 5 mg/dL

(0.3mmol/L)

26/40 (65 %) 34/40 (85 %) 39/40 (97.5 %)

Number and % of results within reference (for values were ≧ 75 mg/

dL(4.2 mmol/L))

Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 %

67/200 (33.5 %) 135/200 (67.5 %) 178/200 (89 %) 197/200 (98.5 %)

Precision:

This study shows the variability from strip to strip in blood tests. The
results are shown in the folling table.

Within Run Precision

Samples Mean glucose concentration measured CV

Sample 1 57.1 mg/dL(3.2mmol/L)

Within ± 10 mg/dL

(0.6mmol/L)

Within ± 15 mg/dL

(0.8mmol/L)

SD=4.4 mg/dL (0.2
mmol/L)

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Sample 2 99.6 mg/dL(5.5mmol/L) 3.0%
Sample 3 152.4 mg/dL(8.5mmol/L) 2.8%
Sample 4 247.8 mg/dL(13.8mmol/L) 2.9%
Sample 5 400.0 mg/dL(22.2mmol/L) 3.1%
Between Day Precision

Control solution 1 56.2 mg/dL(3.1mmol/L)

Control solution 2 104.1 mg/dL(5.8mmol/L) 3.2%
Control solution 3 306.1 mg/dL(17.0mmol/L) 2.9%

SD=4.2 mg/dL (0.2
mmol/L)

Chapter 9 Specication and Maintenance

Measuring range: 20~600mg/dL or 1.1~33.3mmol/L

◆

Measuring unit: mg/dL or mmol/L

◆

Measuring time: Approximately 5 seconds

◆

Blood Sample size: Approximately 1μL

◆

Operating temperature: (10℃~40℃)/(50 ºF ~104ºF)

◆

Store the test strips at ambient temperature between

◆

4~30℃(39ºF ~86ºF). Do not refrigerate.

Relative operating humidity: Below 90% RH

◆

Relative storage humidity: Below 75% RH

◆

Memory capacity: Up to 512 test results (together with

◆

date, time and unit) include average results for the last 7,
14 and 28 days

Dimension: 9.0 x 6.0 x 2.5 cm (L×W×H)

◆

Weight: Approximately 90g with batteries

◆

Power supply: Two 1.5V AAA batteries

◆

Recommend to store in room temperature environment.

◆

Please do not store in high temperature or high humidity.

◆

Please prevent the HEA-230 system against from impact.

◆

Please do not disassemble tthe HEA-230 system.

◆

warning: The measurement unit either mg/dL or mmol/L is xed in the

meter according to the country demand. You are not able to change the
unit in the meter.

Caution: Any further service and product information, please contact

26

OMRON distributors.

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MANUFACTURER

CAUTION BATCH CODE

CONSULT INSTRUCTIONS FOR USE

TEMPERATURE LIMITATION

IN VITRO DI AGNOSTIC MEDICAL
DEVICE

DO NOT REUSE

NUMBER

SERIAL

USE BY

DO NOT USE IF PACKAGE IS DAMAGED

DELBio, INC.
3F, 252 Shangying Road, Guishan Industrial Zone,
Taoyuan County 33341, Taiwan
www.delbio.com.tw

Deltronics (Netherlands) BV
Zandsteen 15, 2132 MZ Hoofddorp, The Netherlands

AUTHORISED REPRESENTIVE IN THE
EUROPEAN COMMUNITY

Council Directive 98/79/EEC
on in vitro diagnostic medical devices

KEEP AWAY FROM SUNLIGHT

STERILIZED USING IRRADIATION

KEEP DR

PAPER RECYCLE

EC

Y

For self-testing

0120

OMRON blood glucose monitoring system HEA-230.indd 27 2012/6/14 上午 11:14:56

27

OMRON blood glucose monitoring system HEA-230.indd 28 2012/6/14 上午 11:14:56

OMRON blood glucose monitoring system HEA-230.indd 29 2012/6/14 上午 11:14:56

OMRON blood glucose monitoring system HEA-230.indd 30 2012/6/14 上午 11:14:56

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