Omron HGM-112 User manual

INSTRUCTION MANUAL
BLOOD GLUCOSE
MONITORING SYSTEM
HGM-112
BASIC
AUTO

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 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, garage door openers, radio transmitter, or other electrical or
electronic 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), before changing treatment patients should refer
to a medical professional.

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Contents
Chapter 1 HGM-112 Blood Glucose System
1.1 Introduction
1.2 Intended Use
1.3 List of Box Contents
1.4 Product and Meter Display
Chapter 2 Installing and Setting up the HGM-112 meter
2.1 Inserting / replacing battery
2.2 Performing a blood glucose test
Chapter 3 Finger Blood Glucose Testing
3.1 Preparation before glucose testing
3.2 Fingertip blood measurment
3.3 Alternate Site Testing (AST)
Chapter 4 Glucose Control Solution Testing (Optional)
Chapter 5 Caring for Your Strips and Meter
Chapter 6 Troubleshooting
Chapter 7 HGM-112 Performance Characteristics
Chapter 8 Specifications
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4.1 HGM-112 system testing
5.1 Caring for the strips
5.2 Caring for the meter
8.1 Specification of HGM-112 meter 20
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BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

Chapter 1 HGM-112 Blood Glucose System
1.1 Introduction
The HGM-112 system measures the small electrical current and displays
the blood glucose results. The current is produced from the blood
glucose mixing well with chemicals on the test strip.
User needs to apply 1μL of fresh capillary whole blood for one test, and
the test result will be displayed in 5 seconds.Besides that, HGM-112 also
has unique strip technology with auto coding system. Users don’t need
to code the glucose meter.
1.2 Intended Use
Only the HGM-STP1A blood glucose test strips are used with HGM-112
meter. They are designed for users to measure the glucose
concentration in fresh capillary whole blood obtained from fingertips and
palm. HGM-112 system is intended to be used by people with diabetes
at home.
Warning: Do not change the therapy according to HGM-112 meter test
result without consulting healthcare professional. If you have
any question about the test results, please discuss with your
healthcare professionals.
Warning: Only for in-vitro diagnostic test.
Warning: Please read system instruction manual and strip manual
carefully
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Warning: HGM-112 system should not be used for screening, diagnosis
of diabetes or testing neonates.
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

1.3 List of Box Contents
1. HGM-112 Glucose Meter
2. Lancing Device
3. AST Cap
4. 10 pcs Lancets
5. Carrying Case
6. Instruction Manual
7. Log Book
8. CR2032 x 1
A.HGM-112 Blood Glucose Meter Display
1.4 Product and Meter Display
Caution: This meter will not display mmol/L.
Strip Slot -
Insert test strip
here
Meter Display
Battery Compartment
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

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B.HGM-STP1A Blood Glucose Test Strip
Warning: Touch the drop of sample to the top edge of the confirmation
window of the test strip. Do not smear sample on the strip.
C
. Function Display
Battery
Glucose data
Unit
Strip Blood icon
Top Edge - Apply blood sample here
Inserting Bar - Insert this test strip into the
meter’s strip slot with this face up
Confirmation Window
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

Chapter 2 Installing and Setting up the HGM-112 Meter
2.1 Inserting/replacing battery
When should users change the battery?
1. When the symbol shows on the display, it means the battery
power is low and need to replace a battery as soon as possible. Even
the battery power is low, HGM-112 meter still can work well:
You still can use HGM-112 and the test results will still be accurate,
but we strongly suggest you replace the battery as soon as possible.
2. There is not enough power to support HGM-112 to operate whe
the symbol is shown on display after powering on. Thus, the
meter will shut down after 20 seconds when the symbol is shown
on display after powering on. It represents that the battery power is too
low to perform a test. You have to replace the battery to continue using
the HGM-112 meter.
How to replace HGM-112’s battery
1. Turn HGM-112 to the back side and open the battery compartment.
2. Take out the battery and insert one CR2032 battery with the (+) sign
facing up.
3. Push back the battery compartment until hearing a “click” sound.
4. After a new battery is inserted and the cover is shut, the device is
powered on automatically for 2 seconds. If not, please check the above
steps.
a. Open battery compartment
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BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

b. Take out and insert a new battery
Warning: Dispose of old battery according to your local
environmental regulations.
2.2 Performing a blood glucose test
A. Inserting a test strip
1. Insert the test strip into strip slot correctly; the HGM-112 meter will turn
on. All LCD segments will display for 1 second.
2. Then the display will show the latest test result for 2 seconds.
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c. Push back the battery compartment
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

B. Apply sample
C. Test blood glucose
4. After apply sample, the test result will show on display after 5
seconds.
There is mg/dL test unit showing on display.
Chapter 3 Finger Blood Glucose Testing
Please prepare materials you need as listed below and read this
instruction manual or test strip manual to ensure the correct measuring
process and results.
□ HGM-112 Blood Glucose Meter
□ HGM-STP1A Blood Glucose Test Strip
□ Antiseptic wipes or alcohol wipes
□ Lancing Device
□ Lancet
3.1 Preparation before glucose testing
2 Sec
3. The strip symbol flashes alternatively with blood symbol as the
following pictures, and users can apply blood sample now.
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

3.2 Fingertip blood measurement
A. Install the Lancet
1. Unscrew the adjustable tip of the lancing advice.Install a new lancet
into the carrier correctly and make sure it is fully seated. Then remove
the protective cap and replace the adjustable tip.
2. Adjust the puncture depth by the selection dial (Normally at the 2nd
level), twist to a suitable number. (Smaller numbers are for shallower
punctures and larger numbers are for deeper puncture)
a. Unscrew the adjustable tip
of lancing device
b. Install the lancet.
c. Twist off the protective cap
from the lancet.
d. Replace the adjustable tip of
lancing device and adjust the
puncture depth.
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Structure:
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1
3
4
Ejector Barrel
Trigger
CarrierAdjustable tip
AST Cap
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

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5. The display will show the latest test result and then strip symbol
and drop symbol will appear.
B. Preparing your Lancing Device
3. Slide the barrel control back until it clicks. The lancing device is now
ready for use.
Warning: Sterile lancet is single use only, cannot reuse.
C. Preparation of test strip
4. Insert the test strip into the strip slot and the HGM-112 meter will turn
on. All LCD segments will display for 1 second.
* Insert the test strip (Correctly) *Do not insert the strip from reverse side.
2 Sec
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

D. Wash your hands and the puncture site
6. Wash hands with soap and warm water. Rinse and dry thoroughly.
E. Fingertip blood sampling
7. Please massage your fingertip gently to help you obtain blood. (We
suggest that you puncture different areas each time. Repeated
punctures in the same area may cause soreness. The blood sample
requires only 1μL, do not squeeze excessively at the puncture site.)
8. Hold the lancing device firmly against the side of your fingertip. Press
the release button gently and squeeze your finger to assist the flow of
blood.
F. Blood glucose test
9. Touch the blood drop to the tip of the confirmation window of test strip.
Caution: Do not smear blood on the
strip, only touch blood to the
tip of the strip.
Touch the blood drop on fingertip to the reaction zone.
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

Sample filled Sample too small
The following items will cause inaccurate results:
□ The reaction zone does not fill completely.
□ Applying blood more than once.
□ Applying blood to test strip after a period of time.
□ Sudden or Huge variation of environment during measurment.
□ Using a false test strip.
G. Blood glucose value display:
10. The blood glucose test will be completed in 5 seconds from the
time the blood drops into the test strip. The last test result will
automatically be stored in the meter memory.
H. Dispose of used strip and lancet properly:
Warning: Please follow proper precautions in accordance with local
regulation when disposing of all materials.
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Important
□ Do not use test strips more than once.
□ It should not be used for testing newborns.
□ It should be used only for testing fresh capillary whole blood.
□ 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% can cause false test results.
3.3 Alternate Site Testing (AST)
You have the option of testing other places on your body besides the
fingertip. You can test the palm. While fingertip blood can be tested at any
time during the day, there are times when testing from any other approved
site is not ideal—usually when your blood glucose is rapidly changing.
Please read the following section before you try testing from other areas.
Caution:
1. Talk to your healthcare professional about Alternate Site Testing.
2. Do not change your treatment because of just one result.
3. NEVER ignore symptoms of high or low blood glucose.
4. If your blood glucose does not match how you are feeling, perform a
fingertip test to confirm your result. If the fingertip result still does not
match how you feel, please refer to the following several items:
Alternate site testing may be done:
• Immediately before a meal
• Fasting
* After use, press the lancet needle
point into the protective cap.
* Push forward the ejector to dispose.
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

DO NOT test from an alternate site:
• Two hours or less after eating
• After exercising
• If you are sick
• If you think your blood glucose is low
• If you often don’t notice when your blood glucose is low
• When basal insulin is most active
• After injecting rapid-acting insulin (two hours or less)
How to do AST :
You need the meter, a test strip, a lancing device designed for AST, and the
clear AST cap.
1. Unscrew the adjustable tip, insert a new lancet firmly into the carrier. Twist
off lancet protective cap and replace the AST Cap. Sliding barrel signals
readiness with a soft click.
2. Insert a test strip into the meter in the correct direction. The meter
turns on.
3. A test strip and flashing blood drop symbol appear on the display.
4. Gently massage the alternative site (palm) that you would
like to draw blood from.
5. Clean your hands and the alternative site you will puncture. Press the
lancing device firmly against a fleshy area on the alternative site. Press
the lancing device up and down in a slow pumping motion to assist
the flow of blood.
6. Trigger the lancing device will be keeping steady pressure on the
puncture site. Immediately lift the lancing device off of the site.
7. Squeeze the puncture site with appropriate pressure slowly to get enough
blood.
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Lift off after lancing device is triggered
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

8. Slightly touch the top of strip with the blood to make enough blood
filled in strip; you can get the test result after 5 seconds.
Warning: The AST function of HGM-112 meter only can be used for palm,
not for other sites such as upper arm, forearm……etc.
Warning: Please follow the lancing device manual to execute AST blood
sampling from palm.
Chapter 4 Glucose Control Solution Testing (Optional)
Warning: If you will like to perform control solution test or have any
question, please contact your local authorized distributor for
more information.
4.1 HGM-112 system testing
In order to provide you with an accurate test result, we suggest running a
control test to check if the meter and test strips are working properly.
When the control result is within the range on the test strip container, the
test strips and meter are working properly.
◆Important:
□ Use Only the OMRON glucose control solution with the HGM-112
meter and HGM-STP1A strips.
□ Mark the newly opened bottle of control solution with the date opened;
discard any unused control solution which is over three months after
opening.
□ Store the bottle at 4oC~30oC (39oF~86oF) temperature. Do not
refrigerate it.
□ Shake the bottle of the control solution before you use it. Please
replace new control solution if control solution deteriorates or
coagulates.
□ We suggest you use OMRON glucose control solution for glucose
control testing between 15oC~25oC (58oF~77oF).
* Before running the test, place the HGM-112 meter, test strips and
glucose control solution at room temperature for 30 minutes to allow
them to reach the new temperature before use.
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2. Running the Glucose Control Solution Test
3) Before using the control solution, gently shake the control bottle to mix
well.
4) Remove the control bottle cap and wipe the tip of the bottle with a
tissue.
5) Squeeze the bottle until a tiny drop forms at the tip of the bottle and
put this drop on a clean surface.
6) Touch the drop to the tip of the confirmation window of the test strip.
When the confirmation window is filled with control solution
completely, the meter will automatically start to run the measurement.
7) After 5 seconds, the screen will display test result. The meter will
automatically turn off after the test strip is removed. Discard the used
test strip in accordance with local regulations.
* Write the date you first open the bottle on the bottle label. The control
solution must be discarded after three months from the date the bottle
was opened, on the “discard＂date or on the “expired＂date on the
bottle label, whichever comes first. Do not use control solution that is
past the “expired＂or discard date.
◆When to run the glucose control solution test：
□ The test strip vial is opened for long time or you think the test strips
have been damaged.
□ When the meter could be damage or not working properly.
□ When you want to double check on the meter’s performance.
◆Running a Control Test:
1. Preparing a Test Strip
1) Insert the test strip into the meter. The meter will display the last
measurement data.
2) Then the screen shows the drop blood symbol.
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BLOOD GLUCOSE MONITORING SYSTEM-HGM-112
Warning: Before running test glucose control solution test, always
check the expiration date. DO NOT use control solution if
expired over three months of first opened day.

Warning: If the control result is not within the acceptable range (printed
on your test strip container), do not use your meter until you
solve the problem. Repeat the control solution test again.
Warning: If the result continues to be outside of the expected
range, here are some points that have to be checked:
□ Did you follow all of the testing instructions?
□ Are the test strips or control solution past the “expired＂date or
discard date?
□ Is there a HGM-112 meter defect in materials or workmanship?
Repeat the control test with a new test strip. If you still have any problem,
please contact your local authorized distributors for more information.
3. Understanding Control Test Results
8) When the control result is within the range on the test strip container ,
the test strips and meter are working properly.
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5.1 Caring for the strips
Chapter 5 Caring for Your Strips and Meter
*Wash hands before testing.
*Do not use strips that have expired. Check the expiration date that is
printed on the package.
*Record the day opened on the test strip bottle label when you first open
it.
*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
between 4 C -30 C. (39 F~ 86 F)
*Do not refrigerate the test strip.
*The strip bottle should be stored in a dry place at room temperature.
*Do not transfer the test strips into other containers.
*Always close the container tightly immediately after taking a test strip
out.
* Keep the test strip from getting dirty during storage.
5.2 Caring for the meter
* If the meter’s surface gets dirty, gently wipe with a cloth slightly
dampened or use a mild detergent.
* For medical staff, you may use a 10% bleach, 70% alcohol (ethanol),
or 10% ammonia scouring reagent.
* Do not clean the test strip slot.
* Do not put any liquid into the test strip slot or on the buttons of the
meter.
* Do not put the meter under water or any liquid.
* The meter must be stored at room temperature.
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

Chapter 6 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 problem or show 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.
Message Symbol Mean Action
HI
You may have a very high
blood glucose level.
( > 600 mg/dL)
1. Do control solution test.
2. Re-do your glucose test.
3. Contact your healthcare
professionals.
LO
You may have a very low
blood glucose level.
(< 20 mg/dL)
1. Do control solution test.
2. Re-do your glucose test.
3. Contact your healthcare
professionals.
Temperature
Error
You may have tested near
the low or high end of the
meter’s operating
temperature range.
(10 C ~ 40 C/50 F ~ 104 F)
Repeat the test after the meter
has reached a temperature
within the operating range.
Low battery
warning
The power is too low to
perform a test.
Replace the battery.
Wrong Test
Strip
Test strip could be expired,
upside down,broken, or
used again.
1.make sure if strip inserting
correctly.
2.use an New HGM-STP1A
test strip if broken, used.
Wrong Blood
Enter Timing
Obtain blood sample too
soon.
Follow instruction step.
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BLOOD GLUCOSE MONITORING SYSTEM-HGM-112