Gmate WHeeL System User manual

User's Guide
Thank you for purchasing the
Gmate™WHeeL System.
Please read this User's Guide
thoroughly before using, and
ensuring correct operation.
Please keep this User's Guide in
safe place for your future reference.

Gmate™WHeeL is very easy to carry around and used for
measuring the glucose level by whole blood whenever you need.
It is also very simple, easy to use and smart. You don't worry
about coding your meter, the Gmate™WHeeL does it
automatically. is only used for testing glucose
level and using only fresh capillary whole blood samples.
is intended for use outside the body (
diagnostic use) by people diabetes at home and by healthcare
professionals in clinical setting. should not be
used for the diagnosis of diabetes without the guidance of a
healthcare professional or for the testing of newborn.
Gmate™WHeeL
Gmate™WHeeL
Gmate™WHeeL
in vitro
Gmate™WHeeL meter has wheel button
to eject the used strip easily and simply.
The small size with stylish design and
ease operation, allows you can bring
everywhere.
Shows much useful information.
Requires very small volume(0.5 L) and
display the result within 5 seconds.
Measures glucose level of whole blood by
AST(Alternate site testing).
No need to change Code number or to
use Code chip when test strip inserting.
μ
Features 1
2
3
4
5
6
TableofContents
About Gmate™WHeeL
Before Starting
Name and Funtion
Cautions
Obtaining Blood Drop
About Alternate Site Testing
Testing Your Blood Glucose
Control Solution Testing
Reviewing Results
Setting the Meter
Replacing the Battery
Error Messages
Troubleshooting
Performance Characteristics
Caring for System
Specifications
4
5
7
10
13
16
18
22
25
28
32
33
35
36
38
40

About Gmate™WHeeL
Gmate™WHeeL includes:
1. Gmate WHeeL Meter
2. Carrying Case
3. Lancing Device
4. Lithium Battery(CR2032)
5. Gmate Blood Glucose Test Strips
6. Lancets
™
™
Documents in your system include this USER’S GUIDE, QUICK
GUIDE and LOGBOOK.
If any items are missing, please contact to local distributor.
4
Before Starting
Symbols
SN
Caution, see instructions for use
Single use only
Expiration date
Serial number
Lot number
Diagnostic medical device
Manufacturer
Authorised representative
Symbol for temperature limitation
Consult instructions for use
Biological risks
Contains sufficient for <n> tests
Direct current
Separate disposal from other household waste
Catalogue number
In Vitro
5

Before Starting
Test principle
The Gmate™WHeeL is designed for detecting a small electrical
current variation, which produced by the reaction of glucose in the
blood sample with the reagents on the strip. This current is varied
by the amount of glucose in the blood sample. The current
variation is calculated to glucose concentration of sample.
Your Gmate™WHeeL comes with a preset time, date and year.
Before your first using the meter, or when you change battery, you
should check the setting of time and date for your local time zone.
In case of you don’t set your meter at first time or after changing
battery, you can hear beep 3 times when inserting a test strip.
See the 28 page(Setting the Meter).
There are two types of glucose units: mg/dL and mmol/L. Your
Gmate™ meter does not allow you to change the glucose unit
yourself in order to prevent misinterpretation of the test results.
The glucose unit has been preset before leaving our factory. If
you have received a Gmate™ meter with the glucose unit
different from the method you use to measure your glucose
levels, do not perform any tests, and contact your local Philosys
distributor for assistance.
Setting the time and date
6
Gmate™WHeeL is intended to be for personal self-testing to
monitoring glucose concentration in fresh whole blood. Gmate™
WHeeL can apply for outside body( diagnostic use) on
fingertips, forearm, upper arm, hand, thigh and calf.
in vitro
Intended Use
Names and Functions
Display test result and other information.
Review stored results and adjust
parameters in setup mode. You can turn
the meter off by pressing '<' button and '>'
button at same time.
Remove the tested strips by rolling.
Insert the Gmate™ Test Strip. The meter
will turn on automatically when inserting
the test strip.
Display Screen
Buttons
Eject Wheel
Insert into test strip slot while facing up.
The fresh blood sample is drawn into.
Sample Tip
Electrodes
Gmate™ Test Strip
Front View
7
Test Strip Port

Names and Functions
Transfer test results to computer(Cable is
optional.)
Data Port
Side View
Battery Cover
Slide cover off for replacing battery.
Rear View
8
Names and Functions
1. Indicates strip code number.
2. Displays current mode.
3. Warning when the battery is low or
need to be replaced.
4. Display test results and messages.
5. Indicate ready to test.
6. Indicates abnormal temperature
warning.
7. Display measuring unit.
8. Display current time.
9. Indicates alarm.
10. Display date and year.
Display
Lancing Device
Clear AST cap
Adjustable cap Lancet holder
Lancet ejector
Release button
Sliding barrel
9
AvgMemSet
mg/dL
am
pm
C
* Clear AST cap is an optional accessory.
Please contact your local distributor.

Cautions
The Gmate™WHeeL is intended for use
outside the body ( diagnostic use)
only.
The uses only the fresh
capillary whole blood for measuring.
The must use with
Test Strip and Control
Solution.
Do not use the for
diagnosis of diabetes without the guidance
of healthcare professional, for testing on
newborns and with arterial blood.
The contains small parts
that may be dangerous if swallowed.
Check the packages when purchasing and
before using the .
Before operating, be sure to read User's
Guide and Insert found in test strip
container carefully.
Do not make any of medical relevance
decision without consulting your physician
and/or having received appropriate
training.
in vitro
Gmate™WHeeL
Gmate™WHeeL
Gmate™ Gmate™
Gmate™WHeeL
Gmate™WHeeL
Gmate™WHeeL
Cautions
for System
10
Cautions
Cautions
for Meter
Keep the out of children’s
reach. When a children swallowed battery
or battery cover accidentally, consult with a
doctor immediately.
Do not dispose the battery into fire.
Do not disassemble or modify the meter.
Do not attempt to severe shock, drop or
step on meter.
The is not waterproof. Do
not wash by water or touch it with wet
hands.
Do not wipe the meter with chemical
solvent or abrasive cleaners.
Avoid the being exposed
to high temperature, high humidity, rain
and/or dust when using or storing.
Do not test instantly when the
moves to where sudden
temperature changes. Please wait 20
minutes and start testing.
Gmate™WHeeL
Gmate™WHeeL
Gmate™WHeeL
Gmate™WHeeL
11

Cautions
Cautions
for Test Strip
Store Test Strip in a cool, dry place
between 2°C and 32°C(36°F and 90°F).
Keep away from direct sunlight and heat.
After taking a test strip out of the container,
close cap tight immediately.
You may get inaccurate result if container
cap remains opened long time.
Don't drop the blood sample on the surface
of strip directly.
Do not press test strip against your finger. It
may affect bad aspiration of blood sample
aspiration.
Do not use a test strip that looks damaged
and/or used. Test strips are for single use
only.
Store the test strips in their original container.
After you take a strip out of the container, be
sure to use it within three minutes.
Use test strips within 3 months(90days) after
opening the container.
By clean and dried hands, you may touch
when taking out test strip and/or insert to
port.
Do not bend, cut, or modify test strips.
Gmate™
12
Obtaining Blood Drop
Wash and cleaning your hands carefully
with soap and warm water for increasing
the blood circulation in finger vein.
Dry hands thoroughly until pricked skin is
dried off.
STEP 1
Unscrew the lancing device cap by turning
counter-clockwise while holding firmly.
STEP 2
13

Obtaining Blood Drop
Insert a new sterile lancet into the lancet
holder.
Twist the lancet cap off.
STEP 3
STEP 4
Hold the lance holder firmly, and pull back
and release the sliding barrel. Now the
lancing device is cocked.
Put the lancing device cap on and close by
turning clockwise.
STEP 5
STEP 6
14
Obtaining Blood Drop
STEP 7
STEP 8
Set the lancing depth by rotating the cap.
1-2 for soft or thin skin, 3 for average skin,
4-5 for thick or calloused skin.
Place the lancing device on finger tip.
While lancing device rest on the finger.
(The harder it is pressed, the deeper the
lance), press the release button to lance.
15
Caution : To avoid the infection possibility:
Make sure to wash the lance position with soap and water
before sampling.
Do not share a lancet or lancing device with others together.
Always use a new lancet - lancets are for single use only.
Keep your meter and lancing device clean.

About Alternate Site Testing
The can measure a blood sample from your
Upper arm, Forearm, Hand, Thigh or Calf alternatively. Obtaining
a blood drop from these “alternate site” may be less pain than a
fingertip. Following figure shows where you can test with the
. Do not apply to moles, veins, bones and
tendons. Consult to your healthcare specialist before doing
alternate site test.
Gmate™WHeeL
Gmate™WHeeL
Upper Arm
Forearm
Hand
Fingertips
Thigh
Calf
16
Caution : Do not test on alternate sites :
when you think your blood glucose level is changing rapidly,
such as within two hours of exercise, a rapid-acting insulin
injection or insulin pump bolus or within two hours after a meal.
When you are testing for hypoglycemia (low blood glucose) or
if you suffer from hypoglycemia unawareness.
Obtaining a blood sample from alternate sites is different than a
fingertips sample collecting.
After inserting a new sterile lancet, put on
the clear AST cap to the lancing device.
Place the lancing device on selected
position, pressing the lancing device for a
few seconds. After then push the release
button to take a sample. Watch through
the clear cap until a sufficient blood sample
is taken. If there is not enough blood,
gently massage the area until a sufficient
sample has been collected.
17
About Alternate Site Testing

Testing Your Blood Glucose
Insert the test strip while electrode end
facing up into the test strip port until stop.
The meter turns on automatically.
STEP 1
After time and date is displayed for a while.
The code number and strip symbol are
displayed. A strip symbol with filling blood
tells you is ready to test.Gmate™WHeeL
STEP 2
Compare and ensure the displayed code
number is same as printed code on test
strip container. If displayed code number is
different, please use another new strip.
STEP 3
18
am
C
AvgMemSet
mg/dL
am
pm
C
Testing Your Blood Glucose
Touch the drop to test strip tip, and hold
until the Gmate™WHeeL beeps. Blood
sample is drawn into test strip.
The screen shows counting progress
during 5 seconds.
When the measuring complete, there is
beep sound. The blood glucose test result
display on screen.
STEP 4
STEP 5
STEP 6
Important : The volume of blood sample
must be over 0.5 microliter(real size" ") at
least.
19
am
mg/dL
am

Caution :
When the test result is above 600
mg/dL(33.3 mmol/L), "HI" is displayed.
When the test result is lower than 10
mg/dL(0.5 mmol/L), "Lo" is displayed.
Roll the eject wheel to discard the used
strip. Test result will be stored in memory
automatically.
STEP 7
Important : The meter turns off
automatically after one minute unused.
But the test result still remains in
memory.
20
Testing Your Blood Glucose
am
am
Caution :
Used test strips and lancets may be considered
biohazardous waste in your area. Be sure to follow
your local regulations for dispose properly.
Unexpected results
When the test result is lower than 50mg/dL(2.7mmol/L) and over
than 250mg/dL(13.8mmol/L), or displays “Lo” or “HI”, contact your
physician or healthcare professional immediately.
If unexpected results are continued, check Gmate™WHeeL by
control solution. See Control Solution Testing(page 22).
Range of expected results
Blood glucose levels will vary depending on food intake,
medication dosages, health condition, stress or exercise status.
Consult your healthcare professional for the target value that is
appropriate for you.
Expected blood glucose levels for non-pregnant person without
Diabetes:
Fasting : Less than 110 mg/dL (6.0 mmol/L)
2 hours after meals : Less than 140 mg/dL (7.8 mmol/L)
21
Testing Your Blood Glucose
Reference: International Diabetes Federation 2009. Self-Monitoring of Blood
Glucose in Noninsulin Treated Type 2 Diabetes.

Control Solution Testing
Gmate™ Control Solution contains a known index of glucose and
is used for checking that the Gmate™WHeeL and test strips are
working properly or not. Control solution is optional.
Do a control solution test:
when doing practice the test process instead of using blood sample,
when you open a new test strips container,
when you suspect the Gmate™WHeeL or the test strips are not
working properly,
when you have unexpected blood glucose results repeatedly,
when the Gmate™WHeeL is damaged.
Insert the test strip while the electrode end
facing up into the test strip port until it
stops. The Gmate™WHeeL will turn on
automatically.
STEP 1
After time and date will be displayed for a
while, code number and strip symbol are
displayed. A strip symbol with filling blood
tells you the Gmate™WHeeL is ready to
test.
STEP 2
22
am
C
Make sure the displayed code number is
same as printed code of the test strip
container. If displayed code number is
different, please use another new strip.
STEP 3
Control Solution Testing
Shake the control solution vial and open
the cap. Gently touch test strip tip to
control solution drop and stay until beeps.
STEP 4
The Gmate™WHeeL shows counting
progress during 5 seconds.
STEP 5
23
am
am
C

Control Test Range
80-120mg/dL
mg/dL
am
Control Solution Testing
Beeps when test is finished. The test result
of control solution is displayed on screen.
STEP 6
Compare the test result with control
solution range which is printed on test strip
container. If the test result is not within the
range, the Gmate™WHeeL and strip may
worked improperly. Repeat the control
solution test.
STEP 7
If your control solution test results are out of the range
continuously, do not use the Gmate™ WHeeL, the test strips
and/or the control solution. Please contact the local distributor.
Out of range results may be caused by:
when you are not comply the instructions on this USER’S GUIDE,
expired, contaminated or watered-down control solution,
expired or damaged test strip,
control solution test is done out of temperature range 20°C to 25°C,
or a problem on the Gmate™WHeeL.
Roll the eject wheel to discard the used strip. Test result is stored
in memory automatically.
STEP 8
24
mg/dL
am
Reviewing Results
STEP 1
During the meter is off, when click any
button, the present time and date are
displayed. After then, a strip symbol is
blinking.
25
am
STEP 2(To enter review mode)
When a strip symbol is blinking, press the
'>' button. The last test sequence number
(=1) is displayed. Release the '>' button,
the last test result is displayed.
Mem
am
Mem
mg/dL
am
Important :
If there is no result, “- - -” is displayed.

Reviewing Results
STEP 3
Press the '>' button, the previous test
number (=2) is displayed. When release
the '>' button, the appropriate glucose
result is displayed.
Press and release the '>' button, you can
review the older test results and the '<'
button is for the later results one by one.
26
Mem
pm
Mem
mg/dL
pm
STEP 4(To review average)
To review your 30-day result average,
press and release '<' button while a strip
symbol is blinking.
Pressing and releasing the '<' button allow
you to scroll forward to 14-day and 7-day
averages.
Avg
mg/dL
Reviewing Results
STEP 5
Press and release the '<' button at the last
test result, you can see the 30-day
average. Press and release the '>' button
at the 30-day average, you can see the
last test result.
STEP 6
Press both '<' and '>' buttons together to
turn the Gmate™WHeeL off.
27
30-day
Average
14-day
Average
7-day
Average
Last
Result
2nd
Result
3rd
Result
A strip shape
is blinking

Setting the Meter
STEP 1
Press both '<' and '>' buttons together for 3
seconds. “Set” is displayed on screen
while the year is blinking.
Press and release the button until the correct
year appears. Decreasing by '<' button, and
increasing by '>' button. Press and release '<' and
'>' buttons together to move to “month” setting.
STEP 2
28
STEP 3
During the month is flashing, press and release
the button until the correct month appears.
Decreasing by '<' button, and increasing by '>'
button. Press and release '<' and '>' buttons
together to move to “day” setting.
Set
Important :
Click the '<' button or '>' button to adjust the parameter.
Press the '<' and '>' buttons together simultaneously to move
to the next setting.
Press the '<' and '>' buttons together for 3 seconds to exit the
setting.
Set
Set
Set
During the date is flashing, click the '<' and
'>'button to select "month-day" or "day
month" format. Press and release '<' and '>'
buttons together to move to “hour” setting.
During the day is flashing, press and release
the button until the correct day appears.
Decreasing by '<' button, and increasing by
'>' button.Press and release '<' and '>'
buttons together to move to the “date format”
setting.
STEP 5
Setting the Meter
During the hour is flashing, press and
release the button until the correct “hour”
appears. Decreasing by '<' button, and
increasing by '>' button. Press and release '<'
and '>' buttons together to move to “minute”
setting.
STEP 6
During the minute is flashing, press and
release the button until the correct minute
appears. Decreasing by '<' button, and
increasing by '>' button. Press and release
‘<' and '>' buttons together to move to the
“time format” setting.
STEP 7
29
STEP 4
Set
Set
pm
Set
pm

Setting the Meter
STEP 8
30
Set
pm
During "12h" or "24h" is flashing, press
and release the '<' or '>' button to select
12-hour or 24-hour format. Press and
release '<' and '>' buttons together to move
to “beeper” setting.
Set
During "On" or "Off" is flashing, press and
release the button to select beeper-on or
beeper-off. Press and release '<' and '>'
buttons together to move to the “alarm”
setting.
STEP 9
Set
am
During "On" or "Off" is flashing, press and
release the button to select the first alarm
on or off. Press and release '<' and '>'
buttons together to move to the second
alarm setting when the first alarm is off.
Press and release '<' and '>' buttons
together to set the time of first alarm when
the first alarm is on.
STEP 10
Setting the Meter
STEP 11
Press and release '<' or '>' button to set
the first alarm time when the first alarm is
on by the same way of previous the hour
and minute settings.
Set
am
STEP 12
After totally settings of four alarms are
completed, press and release '<' and ‘>’
buttons together to finish setup and turn off
the Gmate™WHeeL.
31

32
Replacing the Battery
STEP 1
Prepare the 3V Lithium Button Cell
(CR2032) for replacement. Slide the
battery cover off to arrow direction.
STEP 2
Remove the old battery and place the new
one in the tray while the "+" side facing down.
Slide the battery cover back into place and
close firmly.
STEP 3
Important : If you do not replace the new
battery within one minute after taking the
old one out, you must setup again the
date and time. Replace the battery do
not affect to the meter’s memory and
user settings.
Caution : Dispose of battery
according to your local
environmental regulations.
33
Error Messages
Appears when working temperature is
BELOW or ABOVE system operation
range. The system operation range is
10 ~40°C(50 ~104°F). Re-test after the
working temperature reach to the above
range.
°C °F
Appear when inserting a used test strip.
Re-test with a new test strip.
This error message indicates the Gmate™
WHeeL has problem. Review the
instructions and re-test with a new test
strip. When this messages appears again,
contact the local distributor.
This error message indicates the test strip
may be inserted incorrectly or have a
problem. Repeat to remove and re-insert
the test strip or repeat the test with a new
test strip.

34
Error Messages
Battery is low, still but you can do a few
tests. Replace the battery as soon as
possible.
Battery is too low to perform a test.
Replace the battery immediately.
Mem
mg/dL
pm
35
Troubleshooting
Probable cause What to do
Meter does not enter the test mode after inserting a test strip.
The battery is out. Replace the battery.
The battery is installed wrong
or there is no battery.
Check that the battery is installed correctly.
See 32 page.
Test strip inserted upside
down, wrong end in, or
incompletely.
Insert the test strip with the printed side up and the
electrode end into the test strip port.
Defective meter or test strips. Contact your local distributor.
Blood or foreign objects put
into test strip slot.
Contact your local distributor.
Probable cause What to do
Test does not start after applying the blood sample.
Blood sample is too small. Re-test with a new test strip and a larger blood
sample.
Sample applied when turn off
due to time out(3 minutes
after ready to test).
Re-test using a new test strip.
Defective meter or test strips. Re-test with a new test strip. If same problem
happens, contact your local distributor.

36
Performance Characteristics
The Gmate™ System is calibrated to yield results equivalent to
plasma glucose concentrations and is traceable to a NIST
standard. The accuracy of the Gmate™ WHeeL System was
assessed by comparing blood glucose results obtained by
patients with those obtained using a YSI 2300 Glucose Analyzer.
Clinical accuracy
System accuracy result for glucose concentrations < 75 mg/dL(4.2 mmol/L)
System accuracy result for glucose concentrations 75 mg/dL(4.2 mmol/L)≥
Regression statistics
within ±5 mg/dL(0.28 mmol/L)
within ±10 mg/dL(0.56 mmol/L)
within ±15 mg/dL(0.83 mmol/L)
27% (8/30)
93% (28/30)
100% (30/30)
within ±5%
within ±10%
within ±15%
within ±20%
58% (99/170)
95% (162/170)
99% (169/170)
100% (170/170)
Slope
Intercept
R²
No. of samples
Range tested
1.0004
-2.1214 mg/dL
0.9903
100
32.7~442 mg/dL(1.8~24.5 mmol/L)
37
Within run precision(100 venous blood tests per glucose level)
Total precision(100 control solution tests per glucose level)
Performance Characteristics
Standard
deviation
1.3 mg/dL(0.07 mmol/L)
2.6 mg/dL(0.14 mmol/L)
2.6 mg/dL(0.14 mmol/L)
3.6 mg/dL(0.20 mmol/L)
8.8 mg/dL(0.49 mmol/L)
Mean glucose
43 mg/dL(2.3 mmol/L)
101 mg/dL(5.6 mmol/L)
133 mg/dL(7.3 mmol/L)
232 mg/dL(12.8 mmol/L)
373 mg/dL(20.7 mmol/L)
Coefficient of
variation(%)
3.1
2.5
2.0
1.6
2.4
Standard
deviation
0.8 mg/dL(0.04 mmol/L)
2.5 mg/dL(0.14 mmol/L)
8.5 mg/dL(0.47 mmol/L)
Mean glucose
41 mg/dL(2.2 mmol/L)
103 mg/dL(5.7 mmol/L)
295 mg/dL(16.3 mmol/L)
Coefficient of
variation(%)
2.0
2.4
2.9

Caring for System
Store your meter, strips and control solution in your carrying case
after each use. Store in a cool, dry place below 32°C(90°F), but
do not make refrigerated. Keep all items away from direct sunlight
and heat.
Tightly close the cap on the test strip container and/or control
solution vial immediately after use, to avoid contamination or
damage. Store test strips only in their original container.
Storing your system
Your Gmate™WHeeL is maintenance-free.
Checking for expiration to strips and control solution
Caution :
Do not use the strips or control solution after the expiration
date printed on the container or the discard date(date first
opened plus 3 months), or your results may be inaccurate.
Do not use test strips if the container is damaged, broken or
left open to air. It cause to error, or is higher than the actual
result.
38
Test strips and control solution have expiration date, which is
printed on their containers. When open a test strip or control
solution vial first time, you must write down the opening date on
provided label. Use all test strips within 3 months after opening.
Caring for System
To clean up your meter, wipe the outside with a soft cloth,
dampened with water and mild detergent. Do not use alcohol or
any chemical solvent. Do not remain any liquids, dirt, dust, blood
or control solution inside of the test slot.
Cleaning your meter
Clean and wipe the outside of the lancing device with a soft cloth,
dampened with mild detergent and water. Clean the adjustable
cap and clear AST cap with mild detergent. Do not immerse the
lancing device in any liquid.
Cleaning your lancing device and clear AST cap
39