Omron HEA-230 User manual

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
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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-of-
art 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.
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.
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Test port
-Insert test strip
here
Meter disply
Right Button
-Power on & off
Left Button
-Setting
Data port
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
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.
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Top Edge
-Apply blood sample here.
Inserting Bar
-Insert this test strip into the
meters’ strip port with this side
facing up.
B. Strip appearance
C. Function display
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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
cover back
to the battery
compartment
2.2 Setting up your meter
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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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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4. Measuring blood glucose concentration
After the blood glucose measurement, sign ashes. Then you
can also press left or right button to review past results or hold down
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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Adjustable tip Carrier Trigger Barrel
Ejector
a. Twist the cap to remove it. b. Install the lancet.
c. Twist the protective cap
from lancet.
d. Install the tip of lancing
device and adjust the
puncture depth.
3.2 Fingertip blood measurement
Appearance of the lancing device:
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.)
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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.
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).
Touch the blood drop of ngertip to the reaction zone.
Warning :To protect test strips from exposure to air, please press the
cap of the vial till it “clicks”.
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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.
Sample filled Sample too small
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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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HEA-230
◆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.
Fingertip blood test mode Press the left button to enter
glucose control solution test
mode
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.
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