OSANG Healthcare GluNEO M3 User manual
Blood Glucose Monitoring System
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Dear GluNEO® M3 blood glucose monitoring system Owner,
Thank you for choosing the GluNEO®M3 Blood Glucose Monitoring System. This manual contains
everything you need to know about your new glucometer and how it works. Please take a moment to read
the instructions carefully.
We understand that self-testing of blood glucose level provides a way to control your diabetes and may
give you peace of mind by testing regularly. GluNEO®M3 has been developed to provide you with a fast
and accurate reading in a convenient and simple process. Our goal for the GluNEO®M3 Blood Glucose
Monitoring System is to provide you with the best quality healthcare products coupled with superior
customer service. Always consult with your healthcare professional, before making any changes to your
diabetes management. The GluNEO®M3 Blood Glucose Monitoring System is for in-vitro diagnostic use
only.
Customer Service is available 24 hours a day, 7 days a week, and 365 days a year. Please call customer support center in
your local area.
Important information
The GluNEO®M3 Blood Glucose Monitoring System is intended for use outside the body (in-vitro diagnostic
use only). It should be used only for testing blood glucose with fresh whole blood samples(Capillary and/
or venous). It should not be used for the diagnosis of diabetes. Consult with your physician or diabetic
healthcare professional about daily management of your diabetes and proper use of the glucometer. Please
pay close attention when handling blood. Improper procedures may cause serious hazards to your health.
The GluNEO®M3 Blood Glucose Monitoring System contains small parts, which could be a choking hazard
for children if swallowed.
- 3 -
Test principle
GluNEO®M3 blood glucose test strip is the bio-sensor which is composed of the FAD-dependent Glucose
Dehydrogenase(enzyme). FAD-GDH(enzyme) quantitatively reacts with the glucose in the whole blood and
the mediator. Glucose in the whole blood sample reacts with the reagent of the test strip and generates an
electrical. The amount of current, which is related with glucose concentration, is measured by the current,
for which the method is called amperometry.
WARNING
•
All parts of the kit are considered bio-hazardous and can potentially transmit infectious diseases, even after you
have taken cleaning and disinfection measures.
•
Always use a new, sterile lancet. Lancets are for single use only.
•
Avoid getting hand lotions, oil, dirt or debris in and/or on the lancets and reusable lancing device.
•
Please refer to page 29 for cleaning and disinfecting GluNEO®M3 Blood Glucose Monitoring System.
•
Do not change your medication based on the GluNEO®M3 meter test results without contacting your physician or
healthcareprofessionalrst.
•
Do not assemble or disassemble the blood glucose test meter.
•
Keep out of direct sunlight.
CAUTION
•
Please keep your monitoring system out of reach of children.
•
Make sure it does not come in contact with water and moisture.
•
Avoid getting dirt and moisture.
•
Close supervision is necessary when equipment is used by, on, or near children, handicapped persons or invalids.
•
Do not place the equipment in liquid, nor put it where it could fall into liquid. If the equipment becomes wet,
unplug it before touching it.
•
Do not use accessories which are not supplied or recommended by the manufacturer.
•
Do not place anything on top of the equipment.
NOTE:
•
Blood Glucose Monitoring System may also be called as Blood Glucose Test Meter, the Meter, Test Meter in this
manual, for which they have equal meaning to each other.
•
Blood Glucose Test Strip may also be called as the Test Strip, Strip, for which they equal meaning to each other.
- 4 -
Table of contents
Learning the System
Intended use 5
GluNEO®M3 kit contents 6
GluNEO®M3 meter 7
GluNEO®M3 meter display 8
GluNEO®M3 test strip 9
Before Testing
Setting your meter 10
Auto-coding function 12
Performing a glucose control solution test 13 - 16
Performing your test
Testing blood - preparation 16 - 17
Performingabloodtestwithyourngertip 18 - 21
Test Strip ejector function 22
Reviewing your results
Reviewing your blood glucose 23
Reviewing your averages 23
Deleting test results 24
Alternate site test
Lancing and sampling from an alternate site area 25 - 27
Lancing device clear tip is used for alternate site testing 27 - 28
Caring for your GluNEO®M3 system
Cleaning your meter and maintenance 29
Storage of your GluNEO®M3 system 30 - 31
Bluetooth Function 32-33
Transferring your result data 34
Battery installation 35
Disposing 36
Trouble-shooting 37 - 38
Inconsistent or unexpected test results 39
Warranty 40
Specications 41
Symbol reference 42
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Learning the system
Intended use
The GluNEO®M3 test meter is used with GluNEO®M3 test strip for the measurement of glucose in fresh
whole blood samples(Capillary and/or venous). It should not be used for the diagnosis or screening of
diabetes or for the testing of new born babies.
GluNEO®M3 Blood Glucose Monitoring System is intended for use outside the body only (in-vitro diagnostic
use).
GluNEO®M3 Blood Glucose Monitoring System is for self-testing by people with diabetes and by healthcare
professionals.
Recorded results make it easier for your doctor to access your metabolic control.
However, the self-testing should not take the place of overall diabetes management assessment from your
doctor.
CAUTION
•
Do not use system for any other purpose than blood glucose test.
•
Cholesterol concentrations > 500 mg/dL or triglyceride concentrations > 3,000 mg/dL may produce elevated
reading.
•
Icodextrin does not interfere with GluNEO®M3 test strips.
•
Do not use during or soon after xylose absorption testing. Xylose in the blood will cause interference.
•
Before using any product, please read all instructions.
•
Consult with your physician or diabetic healthcare professional about daily management of your diabetes and
proper use of the glucometer. If you have any questions about the GluNEO®M3 product, please contact your local
representative.
NOTE:
•
Before using GluNEO®M3 system, read all instructions in this manual, and practice for accurate and safe test. You
should have commentary recommendation from your diabetes care professional for the proper use of the meter
and daily management of your diabetes.
•
If you think your blood glucose results are too low or too high, or if the results are doubtful, please contact your
doctor.
•
If your blood glucose result is unusually low or high, or you do not feel the result is correct, repeat the test again
with a new test strip.
•
If the results are still inconsistent, please consult with your physician before making any decision in controlling your
diabetes.
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GluNEO® M3 kit contents
3
1. GluNEO®M3 Meter
2. GluNEO® M3 Test strip(optional)
3. Reusable Lancing Device(optional)
4. Lancets(optional)
5. Instructions for use
6. Warranty Registration Card
7. Carrying Case
8. Patient Logbook
9. 2EA 3V Coin Battery (CR2032)
Your GluNEO®M3 Blood Glucose Monitoring System has been sealed to protect the contents.
Ifyoundyoursealhasbeenbroken,pleasereturnittotheplaceofpurchase.
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GluNEO®M3 meter
CAUTION
•
Do not use GluNEO® M3 glucose test meter in a dry environment, especially if synthetic materials are present.
Synthetic clothes, carpets, etc., may cause damaging static discharge in a dry environment.
•
Do not use GluNEO®M3 glucose test meter near cellular or cordless telephones, walkie-talkies, garage door
openers, radio transmitters, or other electrical equipment that are sources of electromagnetic radiation, as these
may interfere with the proper operation of the glucose test meter.
Display Screen:
Displays your test results, symbols, and messages.
Data Port:
Send Stored data to the PC
Power/Enter Button:
Powerthemeteron/o,promptsmemorydataandactsasan"Enter"
button during setup and after tests.
Test Strip Port:
Insert the GluNEO®M3 test strip
Battery Cover
Serial Number
Test Strip Ejector:
Releases and discards test strip.
Up/Down Arrow Buttons:
Scroll up or down to adjust settings or retrieve memory.
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GluNEO® M3 meter display
Low Battery Warning
Before Having a Meal
After Having a Meal
Pasting
Blood Drop Symbol for Test
Memory Mode
Setting Mode
Bluetooth Function
Average Test Result
Warning
Measurement Unit
Date
Time
Test Strip Code
Alarm
Control Solution
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GluNEO®M3 test strip
Conrmation windowTarget to apply blood Contact Bar
CAUTION
•
Store the GluNEO®M3 test strip vials in a cool, dry place. Keep out of direct sunlight. Do not freeze.
•
Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container.
•
Immediately replace the vial cap and close tightly after removing any test strips from the vial.
•
Makeanoteoftheexpirydate,whichissixmonthfromthedateyourstopenanewvialofteststrips.Throw
GluNEO®M3 test strips and vial away after the expiry date.
•
Do not use the test strips after the expiration date printed on the package or vial, since it may cause inaccurate
results.
•
GluNEO®M3 test strips should be single use only. DO NOT RE-USE.
•
Do not test at temperatures below 10°C(50°F) or above 40°C(104°F).
•
Do not test in the condition that humidity is below 10% or above 90%.
•
Do not bend, cut, or alter the test strip.
•
Avoid getting dirt, food, and water on the test strip with wet hands.
•
Avoid getting dirt, food, and water on the color-coding label (backside of test strip)
•
Refer to additional information in the GluNEO®M3 test strip package.
•
Use only GluNEO®M3 test strip with your GluNEO®M3 meter.
Before testing
WARNING
To reduce the chance of infection:
•
Lancing device and lancets should NOT be shared with others.
•
Always use a new lancet and a new blood glucose test strip.
•
Practice using the lancing device and become accustomed with its use.
•
Lancets and blood glucose test strips should be single use only.
•
Wash your hands in warm and clean running water using soap before testing.
•
Avoid getting hand lotion, oils, dirt or debris on the lancets or on the lancing device.
•
Dry your hands completely before testing.
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Setting your meter
The GluNEO®M3 Meter has a wide variety of functions to choose.
Thesetupmodeyoucanturnactivity/mealags,setthedate/time,designatethreeuniqueaverages,and
setuptovedailyalarms.
Power On
Press for 3 seconds at least.
User Activity Option
After pressing and releasing
either ▲or ▼buttons to turn
theUserActivityOptionon/o,push
button.
Year
After pressing and
releasing either ▲or ▼buttons
to set the year,
push button.
Date / Time
After pressing and
releasing either ▲or ▼
buttons to set the date
and time, respectively
push button.
Test Unit
After pressing and
releasing either ▲or ▼
buttons to set the test
unit(mg/dL or mmol/L),
push button.
Number of days for
average
After pressing and releasing
either▲or ▼buttons to set
the number of days for average
calculation(3dierentsettings
possible), push button.
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Alarm on/o
After pressing and releasing
either ▲or ▼buttons to turn
thealarmon/o,
push button.
Alarm time
After pressing and releasing either
▲or ▼buttons to set the alarm
hour and minute, push button.
Alarm
After programming the number
of desired alarms (5 alarms
possible),push button.
CAUTION
•
VERY IMPORTANT: Set the right test unit. Your GluNEO®M3 Meter is pre-set to mg/dL as test unit. A wrong test unit
will lead to wrong test result display. Please consult your healthcare professional if you’re not sure which test unit
to use. Without setting the date properly, the average glucose level and the results in memory will not show proper
values. It is recommended to set the glucose test meter before use and also when new batteries are installed.
•
You cannot test your blood glucose in the setting mode.
•
Toturnthemeteroduringthesetup,press for at least 3 seconds.
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Auto-coding function
1. GluNEO®M3 has automatic code recognition function (e.g.125)
2. It recognizes the code number automatically.
This is a very convenient function preventing the inconvenience of setting
the code number on the glucose test meter every time.
Check the code on the vial to see if the codes match each other
CAUTION
•
Do not bend the glucose test strip to prevent the automatic code recognition failure.
•
If the code recognition label is damaged, code recognition may fail. Please check the code number on the LCD
window together with the code number on the glucose test strip vial to see if code numbers match each other.
제조번호 :
제조일자 :
사용기한 :
품목명 : 개인용체외진단검사시약Ⅱ
M3
125
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Performing a glucose control solution test
GluNEO®M3 control solution contains a known amount of glucose that reacts with GluNEO®M3 test strip.
By comparing your control solution test results with the expected range printed on the test strip vial, you
are able to check that the meter and test strips are working properly, and that you are performing the test
correctly. It is very important that you perform routine checking to ensure accurate results.
The Glucose control solution should be used
- Before using a new box of test strips.
- Whenever you suspect the blood glucose test meter or blood glucose test strip is not functioning properly.
- If your blood glucose test results are not consistent with your symptoms, or if you think results are not
accurate.
- If you have dropped the blood glucose test meter.
- For quality control in the point of care usage.
- For teaching or learning the system.
- When using the meter for blood glucose tests after any disinfection procedure.
1. Firmly insert the test strip into the meter test port. Insert deeply in
direction of arrow on test strip.
Please do not insert the glucose test strip upside down.
2. When you insert the glucose test strip into the glucose test meter, the
power automatically adjusts the meter accordingly.
3. Press and release either the ▲or ▼button, then, Control Solution bottle
icon will appear. Then, press ( ).
제조번호 :
제조일자 :
사용기한 :
품목명 : 개인용체외진단검사시약Ⅱ
M3
125
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4. Check the expiration date before performing a control solution test. Do not
use if expired. Please note the expiration date marked on the control solution
bottle.
5. Gently shake the control solution before use.
6. Discard the 1st drop of control solution. This will eliminate any residue.
Place a drop of control solution liquid on a clean, dry surface (e.g. the lid of
the test strip vial)
7. Dip the test strip into the control solution liquid. Results will appear in 5
seconds.
Compare the result to the range printed on the test strip vial. Result should
fall within that range.
CAUTION
•
Control solutions is for in-vitro diagnostic use only. This means that it is only used for testing outside the body.
•
Control solution is exclusively made for the GluNEO®M3 Blood Glucose Monitoring System. Do not use other brand
control solutions made by other manufacturers.
•
Check the expiration date on the vial. Do not use, if expired.
•
Once opened, use it for the next three months only. Record the discard date on the control solution bottle. Discard
after three months.
•
Do not swallow. This is NOT for human or animal consumption.
•
The control solution bottle icon contains letter ‘C,’ so as not to be confused with the medication bottle. This will
allowyoutounderstanddierencesbetweenacontrolsolutiontestandanactualbloodtest.
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For example only
If you are using the normal control solution, according to this particular vial of strips, your meter should
show a number between 80 and 120.
Please note that the control values shown in the picture are not control ranges.
NOTE
•
It is recommended that glucose control solution is stored at room temperature 20~25°C (68~77°F) before testing.
•
Check the expiration date before performing a glucose control solution test.
•
Do not use if it expired. Once opened, the control solution expires after 6 months.
If your control solution test falls out of range, please follow the next steps before
contacting customer support:
- Check the expiration dates on all the products you are using. Be sure you are using GluNEO®M3 Control
Solution.
- Try another control solution test.
If this test falls out of range, try another control solution test with a new unopened bottle of test strips.
If you continue to get control soulution test results that fall outside the range, do not perform a glucose
test. Please call customer support in your local area.
L: 35-65
N : 80-120
H : 225-345
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Follow-up action
1. Check your meter and test strips with the glucose control solution.
2. Perform your test again.
CAUTION
•
If your glucose control solution falls out of range, do not perform a glucose test and please contact your local
representative.
•
The glucose control solution’s measurement range has nothing to do with individual’s blood glucose level, as its
own purpose is to check the status of test strip and meter. Discard the used control solution and test strips carefully,
according to the local regulation.
Performing your test
Testing blood - preparation
Lancing device is a convenient medical tool for collecting capillary blood samples for glucose monitoring
or other tests which require one or two drops of blood. Being a more advanced lancing device, it provides
ultimatesafetyandcomfortforobtainingbloodsamples.Anadjustabletipoers5dierentstrengthlevels
of skin penetration for individual user’s comfort, while a lancet ejector enables the safe disposal of the used
lancet. As an added bonus, this also comes with a transparent tip for AST (Alternative Site Testing).
CAUTION
•
Never use a lancet that has been used by someone else. This could lead to contamination.
•
If the lancing device is to be used by another person, the unit must use a new tip or properly disinfected
•
Do not leave the lancet in the device after use.
•
A new lancet must only be placed into the lancing device directly before testing.
•
This device has many small parts and could be a choking hazard for children if swallowed.
•
In the case of hospital use, hospitals need to observe their own infection control protocols in order to avoid any
contamination.
•
Always dispose of the used lancet in a biohazard garbage container.
- 17 -
Components
Using the clear tip (AST)
1. Place the lancing device and lancet on the skin in the chosen area, press and hold it continuously for a few
seconds, then push the release button to take a blood sample.
2.Watchthroughthecleartipuntilasucientbloodsampleistaken.Ifthereisnotenoughblood,gently
massagetheareauntilasucientsampleiscollected.
Storage
Products must be stored at room temperature protected from sunlight or moisture.
Cleaning and disinfection
- Clean and wipe the outer part of lancing device once a week at the minimum with a soft cloth dampened
with mild soap and water. Wash the adjustable tip and clear tip, once a week with mild soap.
- DO NOT immerse the lancing device in water or liquid.
Warranty
Lancing device has a 2-year warranty from the date of purchase.
A malfunctioning device should be returned to the following address
Clear Tip Sliding Barrel
Lancet Holder
Ejection System
Release ButtonDepth Indicator/
Adjustable Tip
- 18 -
Performing a blood test with your fingertip
Step 1
1. Firmly insert the test strip into the meter test port in the direction of arrow
on test strip. Please do not insert the glucose test strip upside down.
제조번호 :
제조일자 :
사용기한 :
품목명 : 개인용체외진단검사시약Ⅱ
M3
125
2. When you insert the glucose test strip into the glucose test meter, the
power automatically turns on with the code.
Make sure the code number matches on the test strip bottle (e.g. 125).
GluNEO®M3 automatically recognizes the test strip code number and adjusts
the meter accordingly.
3. A blinking blood drop symbol will appear at the top of the screen, which
indicates that the meter is ready for testing.
CAUTION
•
If the code is not displayed after for a while, pull the glucose test strip out of the port, and re-start the procedure
from the beginning.
•
If the code on the LCD display window as well as on the glucose test strip vial does not match, try another new
glucose test strip. If the mismatch persists, please contact your local representative for assistance.
•
Avoid testing under direct sunlight, for a more accurate test result.
•
If you apply your blood sample too early, Er5 message will appear on LCD. Please refer to Page 35.
- 19 -
Step 2
To obtain a suitable blood samples
•Beforeobtainingabloodsample,washyourhandswithwarm,cleanwaterandsoap.Dryhands
completely before testing.
WARNING
•
All parts of the kit are considered biohazardous and can potentially transmit infectious disease, even after you have
conducted cleaning and disinfection measures.
•
Avoid getting hands lotion, oil, dirt or debris in or on the lancets (single use only) and the lancing device.
•
Wash your hands thoroughly with soap and clean water after handling the meter, lancing device and/or test strip.
3
3 5
1 2 3 4 5
1
3
1. Unscrew the lancing device tip.
3
3 5
1 2 3 4 5
1
3
2. Insert a sterile lancet into the lancing device.
3
3 5
1 2 3 4 5
1
3
3.Twisttheprotectivecovero.
Do not discard.
3
3 5
1 2 3 4 5
1
3
4. Put the lancing tip back and twist it tightly.
3
3 5
1 2 3 4 5
1
3
5. To adjust the depth setting:
Use strength level 1-2 for soft skin, 3 for
average skin, 4-5 for thick or calloused skin.
3
3 5
1 2 3 4 5
1
3
6. Pull the end of the lancet device back.
- 20 -
3
3 5
1 2 3 4 5
1
3
7.Toprickyournger,pushthecenterbutton.
CAUTION
•
If the blood smears or runs, do not use such blood sample. Dry the area and gently squeeze another drop or
punctureanewareaofthenger.
•
Do not share reusable lancing device with anyone including other family members.
Step 3
GluNEO®M3 Test Meter only requires 0.9 ul sample volume.
•
Stick the edge of the test strip to the drop of blood.
•
The blood will automatically be ‘drawn’ into the test strip channel.
•
When your sample blood is enough, your meter will automatically count down.
•
Applyyourbloodtotheglucoseteststripanddonottakeoyourngeruntilyougetthebeepsound.
The test will automatically start.
•
Please respect recommended quantity of blood sample. Too much blood may cause malfunction of your
meter by contaminating it.
CAUTION
•
If the countdown does not start, do not add more blood to the glucose test strip. Discard the glucose test strip and
re-start testing.
•
Ifyoudonotconductthetestwithin3minutes,theglucosetestmeterwillautomaticallypowerotosavebattery
life. In this case, test procedure should start again from the beginning.
•
Youmaygetaninaccurateresultifthebloodsampleisnotcompletelylled.
•
Applyyourbloodtotheglucoseteststripanddonottakeoyourngeruntilyougetthebeepsound,Thetestwill
automatically start
Incorrect
Correct
Completely Filled
Poorlylled
Table of contents
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