User's Guide
10 Automatic power off 3 minutes
11 Power supply One 3-volt lithium battery (type CR 2032)
12 Display LCD
13 Dimensions 97 × 60 × 16.5mm (LWH)
14 Weight Approx.55.2g
15 Test Results Average 7,14,21,28-days AC / PC average
16 Construction Hand-held
17 Meter type
The GlucoLeader Enhance 2 Meter is suit-
able for continuous
18
Control solution storage
conditions
Refer to the control solution package insert
TAKING CARE OF YOUR METER
REPLACING THE BATTERY
The GlucoLeader™ Enhance 2 Blood Glucose Meter comes with a battery (not
yet be installed when new purchasing). Please install your battery before
starting.
Battery life will vary depending on usage, so always keep a spare on hand.
The battery should last about 12 months when testing 3 times a day.
When the battery symbol appears on the meter display, battery is getting low.
You will still be able to test with low battery, but you should replace it as soon as
possible. When battery symbol appears ashing on the display, the meter will no
longer give results and you must replace the battery immediately.
TO REPLACE THE BATTERY
1. Make sure the meter is turned off.
2. Let the front of meter rest in the palm of your hand.
3. Slide battery compartment door open.
4. Remove the old battery and insert the new 3 -volt Lithium battery into the bat-
tery compartment. Be sure to align the plus (+) and minus (-) signs correctly.
5. Slide battery compartment door closed. Check to see that your meter is work-
ing. If it fails to turn on, the battery may have been inserted incorrectly. Re-
move the battery and reinsert it correctly.
NOTE: EVERY TIME WHEN YOU REPLACE THE BATTERY, THE METER
WILL TURN ON AUTOMATICALLY AND ENTER TO THE TIME/DATE SET-
TING. PLEASE SET CORRECT TIME AND DATE BEFORE TESTING.
CLEANING
Clean the outside of the meter with a soft cloth, slightly dampened with water.
Do not get moisture into the strip slot and data port.
STORAGE AND HANDLING
Keep your meter free of dust or water. Protect it from extreme temperature and
humidity.
DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE
When any of the following messages appears, there is a problem with your
GlucoLeader™ Enhance 2 Blood Glucose Meter or the way in which you are
performing a test. These messages will help you to identify certain problems. If
error messages appear that are not listed on the following pages, contact with
your local distributor for help.
DISPLAY DESCRIPTION ACTION TO TAKE
Display check. If some parts of the display are not
working,contact your local distributor for help.
Blood glucose result may
be higher than 600 mg/dL or
33.3 mmol/L.
If you nd the result is doubtful and hard to
believe, review proper testing procedure and
perform a quality check with glucose control
solution. Repeat blood test, if “HI” still appears,
call your doctor immediately.
Blood glucose result may be
lower than 10 mg/dL or 0.6
mmol/L.
If you nd the result is doubtful and hard to
believe, review proper testing procedure and
perform a quality check with glucose control
solution. Repeat test, if “LO” still appears, call
your doctor immediately.
Blood glucose result is higher
than 320 mg/dL or 17.7 mmol/
L.
If you nd the result is doubtful and hard to be-
lieve, review proper testing procedure and perform
a quality check with glucose control solution.
Repeat blood test, if “ ” still appears, call your
doctor immediately.
Blood glucose result is lower
than 70 mg/dL or 3.9 mmol/L.
If you nd the result is doubtful and hard to
believe, review proper testing procedure and
perform a quality check with glucose control so-
lution. Repeat test, if “ ” still appears, please
eat a candy and call your doctor immediately.
Temperature is above or
below the operating range of
test strips.
The result you have obtained may not be accurate.
Move to an area with temperature between 8ºC to
44ºC (46.4ºF - 111.2ºF). Do not articially heat or
cool the meter.
Battery is low. Change battery immediately.
Test strip may be
damaged.
Perform the test with new test strip.
Test strip is used or test was
not performed correctly.
Wait for the blood sign appear before applying
blood.Perform the test with a new test strip and
follow the test procedure correctly.If problem
persists, contact Customer Care.
Maybe:
1.The amount of blood
applied was too small.
Please repeat the test
using a new test strip with
a larger blood drop.
2.Defective test strip
3.Defective meter
Wait for the blood sign appear before applying
blood.Perform the test with a new test strip and
follow the test procedure correctly.If problem
persists, contact Customer Care.
No responses when
strip is inserted into
the meter.
Maybe:
1. Battery is dead.
2. Wrong strip was
inserted.
3. Meter is defective.
You have to:
1. Replace battery.
2. Insert the test strip correctly.
3. Contact us for help.
No responses when
blood sample is applied
to the strip.
Maybe:
1. Blood sample is
not sufcient.
2. Meter is defective.
You have to:
1. Repeat test with sufcient sample.
2. Perform Meter Check by inserting check strip.
NOTE : IF THERE IS ANY ERROR MESSAGE DISPLAYED BUT NOT LISTED
HERE, OR YOUR METER SHUT DOWN FOR NO REASON, YOU CAN RESET
THE METER BY REPLACE THE BATTERY.
PERFORMANCE EVALUATIONS
PRECISION
Tests were carried by trained technicians in the laboratory setting. The venous
whole blood from one subject was adjusted to 6 different levels. Strips out of a
single lot were tested. The results are shown in the following table.
Level No. of tests
YSI Mean
(mg/dL )
Strip Mean
(mg/dL)
With Run SD(mg/dL)
or CV.(%)
1
2
3
4
5
6
100
100
100
100
100
100
31.4
87.4
143.4
225.1
348.3
481.6
25.1
80.4
147.3
221.9
349.7
478
1.5(mg/dL)
2.8(mg/dL)
3.5
%
2.6
%
4.7
%
3.6
%
ACCURACY
600 samples at glucose concentration 46~576 mg/dL were tested at hospital
by healthcare professionals. Fresh capillary nger whole blood samples were
tested with the GlucoLeader™ Enhance 2 System; plasma samples from the
subjects were tested with YSI Model 2300 Glucose Analyzer as reference. The
results are shown in the following table.
Glucose concentration < 100 mg/dL(5.6mmol/L)
Within ± 5mg/dL
(0.28mmol/L)
Within ± 10mg/dL
(0.56mmol/L)
Within ± 15mg/dL
(0.84mmol/L)
85/172 (49.4%) 139/172 (80.8%) 171/172 (99.4%)
Glucose concentration
≧
100 mg/dL(5.6mmol/L )
Within ±5% Within ±10% Within ±15%
242/448(54%) 363/448 (81%) 437/448(97.5%)
Within ± 15mg/dL or ±15%
(Within ±0.84mmol/L or ±15%)
608/620 (98.1%)
User performance
100 samples at glucose concentration 76~339 mg/dL were tested at hospital
by lay user. 94.7% within ±0,83 mmol/L (±15 mg/dL) of the medical labora-
tory values at glucose concentrations below 5,55 mmol/L (100 mg/dL), and
100% within ±15% of the medical laboratory values at glucose concentra-
tions at or above 5,55 mmol/L (100 mg/dL).
Batch code Temperature limitation / Store at
Caution Do not reuse
Keep away from sunlight Biological risks
Please consult instructions for use In vitro diagnostic medical device.
Use by /Expiry date Serial number
Manufacturer
Authorised representative in the European
community
This product fullls the requirement of directive 98/79/EC in vitro diagnostic medical device
The symbol indicating seperate collectionfor electrical and electronic equipment consists of
the crossed-out wheeled bin. When the end-user wishes to discard this product, it must be
sent to seperate collection facilities for recovery and recycling. By separating this product
from other household-type waste, the volume of waste sent to incinerators or land-lls will be
reduced and natural resources will thus be conserved.
HMD BioMedical Inc.
No.181 Minsheng St.,Xinpu Township,
Hsinchu County, Taiwan (R.O.C.)
Tel: +886-3-5895000
FIA Biomed GmbH
Rheiner Strasse 172,
D-48282 Emsdetten, Germany
CODING YOUR METER
Before you use your meter for the rst time and every time you open a new box
of test strips, you need to set the meter to “match” the strips. This is called cod-
ing.
1. Insert the test strip into the strip slot, the meter
will activate. The last code number will appear
on the screen.
Enhance
Set Mem
FIG 2
2. Compare the code number shown on the me-
ter display against the code number on the
test strip vial. If the two numbers match you
may begin blood testing. Otherwise continue
to the next step.
05
05
3. Press Mem button until you hear the sound of
buzzer and the code value ashes, press Set
or Mem button to obtain the code number indi-
cated on the new test strip vial.
Enhance
Set Mem
Mem
4. Upon obtaining the right code number, wait to
ash 3 times to validate the change. When the
symbol ashes, you are ready to perform a
test.
NOTE: THE NEW SETTING CODE NUMBER IS
ALSO DISPLAYED ON THE SCREEN.
Enhance
Set Mem
Mem
PERFORMING BLOOD TEST
1. Wash your hands in warm, soapy water.
Rinse and dry completely.
2. Remove new test strip from vial. Be sure to
tightly replace vial cap after removing test
strips. Insert test strip immediately into strip
slot as illustrated. The meter turns on auto-
matically.
Enhance
Set Mem
3. Check the code number on the meter matches
the number is on the pouch, and also the indi-
vidually wrapped strip. If the 2 numbers match,
you may begin blood testing. Otherwise refer
to previous section to code your meter rst.
05
05
4. When the symbol ashes, you are ready to
perform a test.
Enhance
Set Mem
5. Hold the prepared lancing device rmly against
the side of your nger. Press the release but-
ton. Gently massage your nger to obtain the
required blood volume. To perform the test,
you need only 0.8uL of blood sample resting
on your nger.
6. Apply the blood sample to the right or left ap-
erture of test strip in a way that comfortable
for you. Make sure that the blood drop has
saturated the test conrmation window. When
blood is applied to the strip, a line moves on
the screen until measurement is completed.
7. Test result will show up in 5 seconds. If a count
down number not appear, an error code “E42”
will appears which shows the blood is not
enough. Please do not add blood in the same
strip. Please review the error code table and
problem solving guide section. Before remov-
ing strip from the meter, you can press Set
button to set the test as BEFORE MEAL TEST
(AC ), or AFTER MEAL TEST (PC ), or
a CONTROL SOLUTION TEST (QC ). If not
setting, the default of the meter is BEFORE
MEAL TEST (AC ).
Enhance
Set Mem
8. If the test is been done in 2 hours after meal,
press Set button to change the setting from
AC to PC (8.1). If the test is a glucose
control solution test, press Set button again to
change the setting from PC to QC (8.2).
NOTE: IF A TEST IS SET AS “QC ”, THE
RESULT WILL NOT BE CALCULATE INTO
AVERAGES.
8.1
Enhance
Set Mem
8.2
Enhance
Set Mem
9. After setting complete, remove the strip from
meter and discard the used strip and lancet
safely in a puncture resistant container.
10. The meter has risk indicator function. If is
displayed, your blood glucose result may be
higher than 17.7 mmol/L or 320 mg/dL. If
is displayed, your blood glucose result may
be lower than 3.9 mmol/L or 70 mg/dL.
11. The testing range of the meter is from 10
to 600 mg/dL (0.6 to 33.3 mmol/L). If HI is
displayed, your blood glucose result may be
higher than 33.3 mmol/L or 600 mg/dL. If LO
is displayed, your blood glucose result may
be lower than 0.6 mmol/L or 10 mg/dL.
UNDERSTANDING YOUR TEST RESULT
Expected values for people without diabetes:
Time of Day Expected Range, Non-diabetes
Source: American Diabetes,
Association Position State-
ment, Diabetes Care Vol.37
(Suppl.1) P.S16 (2014).
Before Meal Less than 100 mg/dL
After Meal Less than 140 mg/dL
For diabetes patients, please consult your healthcare professional to nd out
your target blood glucose value.
If your blood glucose result seems unusually high or low, or inconsistent with
your previous results, check the following:
1. Does the code number on the test strip vial match the code number on the
meter?
2. Was the blood sample applied to the test strip immediately after the strip
was removed from the vial?
3. Was the size of the blood sample sufcient?
4. Was the test strip vial cap tightly sealed?
5. Was the test strip used before the expiration date?
6. Were the test strips stored away from extreme temperatures or from areas of
high humidity?
7. Then run a quality control check with your GlucoLeader Glucose Control
Solution and a new test strip. If the control test result is within the acceptable
range, review testing procedure and repeat your blood glucose test with a
new test strip. If your blood glucose value is still inconsistent with your previ-
ous results, contact your doctor immediately for help.
MEMORY RECALL
The GlucoLeader™ Enhance 2 Blood Glucose Meter can automatically store up
to 800 results and auto-calculate your average results of 7-, 14-, 21-, 28- days
on both AC and PC.
When recalling the results, each single result appears from the latest to the ear-
liest with time and date.
To recall Results Stored in Memory
1. Turn meter on by pressing Mem button till you hear a
beep sound. The rst result displayed on the
screen is your latest test result. 12 represents
the 12th recorded of the overall results on this meter.
2. By pressing Mem button, you will see your test record from the most recent
to the oldest.
3. Pressing the Set button to view the average results. “03”
represents within the past 7 days there were 3 AC
-test results. Press the Set button continuously to
view the average results sequentially for 7, 14, 21 and 28 days.
4. Please press the Mem button for 2 seconds to EXIT or put it aside for 3
minutes for auto shutdown.
NOTE: ANYTIME IN MEMORY MODE, YOU CAN PRESS Mem BUTTON UN-
TIL YOU HEAR THE BEEP TO EXIT AND TURN OFF THE METER.
DATA DOWNLOAD
You may download test results to your smartphone, you need to have smart
cable and GlucoLeader Enhance 2 Health2Sync diabetes management App.
The smart cable should be purchased separately. The GlucoLeader Enhance 2
Health2Sync diabetes Management APP is a free iOS and Android apps listed
on the Apple App Store and Google Play. Please search “Health2Sync“ to down-
load the App:
Health2Sync provides innovative diabetes care & analytics service to help dia-
betics and care provider manage diabetes effectively. Through Smart Cable and
Health2Sync App, diabetics can easily manage their blood sugar and relevant
data, and obtain personalized reminders. Care provider can be connected to their
patients through Health2Sync web platform. If you have inquiry, please contact
with your local distributor for more information.
SPECIFICATIONS
1 Blood volume 0.8 micro liters
2 Sample type capillary and venous
3 Test time 5 seconds
4 Measuring range 10~600 mg/dL (0.6~33.3 mmol/L)
5 Test strip storage conditions
35.6°F to 86°F (2°C to 30°C), 10%-90%
humidity
6 Meter storage conditions
-13°F to 158°F (-25°C to 70°C), 10% -90%
humidity
7 System operating conditions
46.4°F to 111.2°F (8°C to 44°C), 10% - 90%
humidity
8 Transportation conditions
35.6°F to 86°F (2°C to 30°C), 10%-90%
humidity
9 Memory capacity 800 blood glucose results
3K-02-XXXXXX V4