OSANG Healthcare GluNEO Lite Smart User manual

Dear GluNEO Lite Smart Blood Glucose Monitoring
System
Owner ,
Thank you for choosing the GluNEO Lite Smart 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 Lite Smart has
been developed to provide you with a fast and accurate reading in a convenient and
simple process. Our goal for the GluNEO Lite Smart 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 Lite Smart 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 Inf ormation
The GluNEO Lite Smart 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 Lite Smart Blood Glucose Monitoring System contains small parts,
which could be a choking hazard for children if swallowed.

Test Principle
GluNEO Lite Smart 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.
W ARNING
1. All parts of the kit are considered bio-hazardous and can potentially transmit
infectious diseases, even after you have taken cleaning and disinfection measures.
2. Always use a new, sterile lancet. Lancets are for single use only.
3. Avoid getting hand lotions, oil, dirt or debris in and/or on the lancets and reusable
lancing device.
4. Please refer to page 33 for cleaning and disinfecting GluNEO Lite Smart Blood
Glucose
Monitoring System.
5. Do not change your medication based on the GluNEO Lite Smart meter test results
without contacting your physician or healthcare professional first.
6. Do not assemble or disassemble the blood glucose test meter.
7. Keep out of direct sunlight.
CA UTION
1. Please keep your monitoring system out of reach of children.
2. Make sure it does not come in contact with water and moisture.
3. Avoid getting dirt and moisture.
4. Close supervision is necessary when equipment is used by, on, or near children,
handicapped persons or invalids.
5. 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.
6. Do not use accessories which are not supplied or recommended by the manufacturer.
7. Do not place anything on top of the equipment.
NOTE:
1. 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.
2. Blood Glucose Test Strip may also be called as the Test Strip, Strip, for which they
equal meaning to each other.

Table of Contents
1. Learning the System
Intended use of blood glucose test meter --------------------------------------------------- 6
GluNEO Lite Smart kit contents ---------------------------------------------------------------- 7
GluNEO Lite Smart meter ------------------------------------------------------------------------ 8
GluNEO Lite Smart meter Display ------------------------------------------------------------- 9
GluNEO Lite Smart test strip ---------------------------------------------------------------------10
2. Before Testing:
Setting your meter ------------------------------------------------------------------------------12
Auto-coding function ----------------------------------------------------------------------------14
Performing a Glucose Control Solution Test------------------------------------------ 15-18
3. Performing your test:
Testing Blood - preparation -------------------------------------------------------------- 19-20
Performing a blood test with your finger tip ------------------------------------------ 21-25
Test Strip ejector function ---------------------------------------------------------------------26
4. Re viewing Your Results:
Reviewing your blood sugar ------------------------------------------------------------------27
Reviewing your averages ----------------------------------------------------------------------27
Reviewing your results with activated user ID --------------------------------------------28
Deleting test results -----------------------------------------------------------------------------28
5. Alternate Site Test:
Lancing and sampling from an alternate site area --------------------------------- 29-31
Lancing device clear tip is used for alternate site testing-------------------------- 31-32
6. Caring f or Your GluNEO Lite Smart System:
Cleaning your meter and maintenance ---------------------------------------------------33
Storage of your GluNEO Lite Smart system ------------------------------------------ 34-35
Bluetooth function ---------------------------------------------------------------------------------- 36
7. T ransferring Your Result Data ----------------------------------------------------------------37
8. Battery Installation -------------------------------------------------------------------------------38
9. Disposal ---------------------------------------------------------------------------------------------39
10. T r oub le-shooting ---------------------------------------------------------------------------- 40-42
11. Inconsistent or Unexpected Test Results ------------------------------------------------43
12. Connection between mHealthGate and GluNEO Lite Smart ------------------------------44
13. Warranty -------------------------------------------------------------------------------------------48
14. Declaration of Conformity ---------------------------------------------------------------------49
14. Specifications ------------------------------------------------------------------------------------50
15. Symbol Ref erence -------------------------------------------------------------------------------51

Learning the System
Intended use
The GluNEO Lite Smart test meter is used with GluNEO Lite Smart 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 Lite Smart Blood Glucose Monitoring System is intended for use outside the body
only (in-vitro diagnostic use).
GluNEO Lite Smart 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 > 510 mg/dL or triglyceride concentrations > 3,400 mg/dL
may produce elevated reading.
- Icodextrin does not interfere with GluNEO Lite Smart 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 manage- ment
of your diabetes and proper use of the glucometer. If you have any questions about the
GluNEO Lite Smart product, please contact your local representative.
W ARNING
- Before using GluNEO Lite Smart 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.

Carrying
GluNEO Lite Smart Kit Contents
Meter Case
Battery
Lancing Device
Lancets
1. GluNEO Lite Smart Meter
2. GluNEO Lite Smart Test
strip
3. Reusable Lancing Device
4. Lancets
5. Instructions for use
6. Warranty Registration Card
7. Carrying Case
8. Patient Logbook
9. 3V Coin (1EA) Battery (CR2032)
Your GluNEO Lite Smart Blood Glucose Monitoring System has been sealed to protect
the contents. If you find your seal has been broken, please return it to the place of purchase.

GluNEO Lite Smart Meter
Test Strip P or t:
Insert the GluNEO Lite Smart test strip
Display Screen:
Displays your test results, symbols, and messages.
Power/Enter Button:
Power the meter on/off, prompts memory data and acts as
an “Enter” button during setup and after tests.
Up/Down Arrow Buttons:
Scroll up or down to adjust settings or retrieve memory.
Test Strip Ejector:
Releases and discards test strip.
Serial Number
Battery Co ver
CA UTION
1. Do not use GluNEO Lite Smart 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.
2. Do not use GluNEO Lite Smart 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.

GluNEO Lite Smart Meter Display
Low Battery Warning Symbol
Alarm Symbol
Troubleshooting Symbol
DATE
Delete Results
Average Test Result System
Before Having a Meal
After Having a Meal
After Taking Medication
After Sport Activity
Control Solution Symbol
Blood Drop Symbol for Test
User ID Symbol
Test Strip Code Symbol
Test Result Unit Symbol
Temperature / Date
Time

GluNEO Lite Smart Test Strip
Test Strip Port
Contact Bar
Caution
1. Store the GluNEO Lite Smart test strip vials in a cool, dry place. Keep out of direct
sunlight. Do not freeze.
2. Store test strips in their original vial only. Do not mix the test strips in new vials or in
any other container.
3. Immediately replace the vial cap and close tightly after removing any test strips from
the vial.
4. Make a note of the expiry date, which is six months from the date you first open a new
vial of test strips. Throw GluNEO Lite Smart test strips and vial away after the expiry
date.
5. Do not use the test strips after the expiration date printed on the package or vial, since
it may cause inaccurate results.
6. GluNEO Lite Smart test strips should be single use only. DO NOT RE-USE.
7. Do not test at temperatures below 10 (50°F) or above 40 (104°F).
8. Do not test in the condition that humidity is below 10% or above 90%.
9. Do not bend, cut, or alter the test strip.
10. Avoid getting dirt, food, and water on the test strip with wet hands.
11. Avoid getting dirt, food, and water on the color-coding label (backside of test strip)
12. Refer to additional information in the GluNEO Lite Smart test strip package.

Bef ore T esting
W ARNING
To reduce the chance of infection:
1. Lancing device and lancets should NOT be shared with others.
2. Always use a new lancet and a new blood glucose test strip.
3. Practice using the lancing device and become accustomed with its use.
4. Lancets and blood glucose test strips should be single use only.
5. Wash your hands in warm clean running water using soap before testing.
6. Avoid getting hand lotion, oils, dirt or debris on the lancets or on the lancing device.
7. Dry your hands completely before testing.

Setting Your Meter
The GluNEO Lite Smart Meter has a wide variety of functions to choose. From the setup
mode you can turn activity/meal flags, set the date/time, designate three unique averages,
and set up to five daily alarms.
Power On
Press for 3
seconds at least.
Y ear
After pressing and
releasing either ▲or ▼
buttons to set the year,
push button.
User Activity Option
After pressing and
releasing either ▲or ▼
buttons to turn the User
Activity Option on/off,
push button.
Date / Time
After pressing and
releasing either ▲or ▼
buttons to set the date
and time, respectively
push button.
User ID Option
After pressing and
releasing either ▲or ▼
buttons to turn the User
ID option on/off, push
button.
Test Unit
After pressing and
releasing either ▲or ▼
buttons to set the test
unit(mg/dL or mmol/L),
push button.

Temperature Unit
After pressing and
releasing either ▲or ▼
buttons to set or and
push button.
Number of days f or
a vera g e
After pressing and releasing
either ▲or ▼ buttons to set
the number of days for
average calculation (3
different settings possible),
push button.
Alarm on/off
After pressing and
releasing either ▲or ▼
buttons to turn the alarm
on/off, 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.
CA UTION
1. VERY IMPORTANT: Set the right test unit.
Your GluNEO Lite Smart 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.
2. You cannot test your blood glucose in the setting mode.
3. To turn the meter off during the setup, press for at least 3 seconds.

Auto-coding Function
1. GluNEO Lite Smart has automatic code recognition
function
(e.g. CODE 125)
125
2. It recognizes the code number automatically. This is a
very convenient function preventing the inconve-
nience 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
CA UTION
1. Do not bend the glucose test strip to prevent the automatic code recognition failure.
2. 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.

Performing a Glucose Control Solution Test
GluNEO Lite Smart control solution contains a known amount of glucose that reacts
with GluNEO Lite Smart 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.
Firmly insert the test strip into the meter test port. Insert
deeply in direction of arrow on test strip (arrow up). Please
do not insert the glucose test strip upside down.
125
When you insert the glucose test strip into the glucose test
meter, the power automatically adjusts the meter
accordingly.
Press and release either the ▲or ▼ button, then, Control
Solution bottle icon will appear. Then, press
( ).

1.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.
2.Gently shake the control solution before use.
3.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)
4.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.
CA UTION
1. Control solution is for in-vitro diagnostic use only. This means that it is only used for
testing outside the body.
2. Control solution is exclusively made for the GluNEO Lite Smart Blood Glucose Monito-
ring System. Do not use other brand control solutions made by other manufacturers.
3. Check the expiration date on the vial. Do not use, if expired.
4. Once opened, use it for the next three months only. Record the discard date on the
control solution bottle. Discard after three months.
5. Do not swallow. This is NOT for human or animal consumption.
6. The control solution bottle icon contains letter ‘C,’ so as not to be confused with the
medication bottle. This will allow you to understand differences between a control
solution test and an actual blood test.

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.
NO TE
- It is recommended that glucose control solution is stored at room temperature 20~25
(68~77 ) before testing.
- Check the expiration date before performing a glucose control solution test.
- Do not use beyond expiration date. Once opened, the control solution expires after 3 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 Lite Smart 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.

Follow-up Action
1. Check your meter and test strips with the glucose control solution.
2. Perform your test again.
CA UTION
1. If your glucose control solution falls out of range, do not perform a glucose test and
please contact your local representative.
2. 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.

P erf orming Y our 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 ultimate safety and comfort for obtaining
blood samples. An adjustable tip offers 5 different strength levels 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).
CA UTION
1. Never use a lancet that has been used by someone else. Sharing lancet could lead
to contamination.
2. If the lancing device is to be used by another person, the unit must be properly
disinfected
3. Do not leave the lancet in the device after use.
4. A new lancet must only be placed into the lancing device directly before testing.
5. This device has many small parts and could be a choking hazard for children if
swallowed.
6. In the case of hospital use, hospitals need to observe their own infection control
protocols in order to avoid any contamination.
7. Always dispose of the used lancet in a biohazard garbage container.

COMPONENTS
Clear Tip
Ejection System Sliding Barrel
Depth Indicator/Adjustable Tip Lancet
Holder
Release Button
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. Watch through the clear tip until a sufficient blood sample is taken. If there is not enough
blood, gently massage the area until a sufficient sample is collected.
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:
put address: