User's Guide

Please read this User Guide before using your GlucoLeader™ Enhance 2
Blood Glucose Meter. If you have any questions or enquiries, please contact us
or your local distributor.
INTRODUCTION
Thank you for selecting GlucoLeader™ Enhance Blood Glucose Monitoring Sys-
tem. This system was produced in close association with diabetes healthcare
professionals, most importantly, people with diabetes.
ABOUT GlucoLeader™ Enhance SYSTEM
Intended Use
The GlucoLeader™ Enhance Blood Glucose Monitoring System (The Gluco-
Leader™ Enhance 2 System) is designed to quantitatively measure the concen-
tration of glucose in capillary and venous whole blood by people with diabetes or
by healthcare professionals for monitoring blood glucose at home or in health-
care facilities. The device is indicated for professional use and over-the-counter
sales. The GlucoLeader™ Enhance 2 System is intended to be used by a single
person and should not be shared. It is intended for self-testing outside the body
(in vitro diagnostic use) by people with diabetes at home as an aid to monitor
the effectiveness of diabetes control.
About the System
The GlucoLeader™ Enhance 2 System are designed to pursuit the accuracy in
blood glucose monitoring to provide you with easy and comfortable testing. The
system requires 0.8μL of blood sample and 5 seconds for the test to complete.
The GlucoLeader™ Enhance 2 System consists of
1) GlucoLeader™ Enhance 2 Blood Glucose Meter
2) GlucoLeader™ Enhance 2 Lancing Device
3) GlucoLeader™ Enhance 2 Blood Glucose Test Strips (Optional)
4) GlucoLeader™ Enhance 2 Control Solution. (Optional)
5) GlucoLeader™ Enhance 2 Check Strip (Optional)
These products are intended to be used together to get accurate blood glucose test
results. Do not use other test strips or glucose control solutions with your meter.
Important Information
The GlucoLeader™ Enhance 2 System is intended for
in vitro
diagnostic
use with capillary and venous whole blood or for testing newborn infant (neonatal
testing). The system should not be used for diagnosis of diabetes.
Caution
1. The user should not take any medical relevant decision without rst consult-
ing medical practitioner.
2. Call your doctor immediately if you experience symptoms that are not
consistent with your blood glucose test results.
3. Severe dehydration or excessive water loss may cause false, high results.
Call your doctor right away if you suspect suffering from dehydration.
4.A sample with large amount of reducing substances such as
Acetaminophen(>10mg/dL), Cholesterol(>500mg/dL), Bilirubin(>10mg/dL),
Glutathione(>23mg/dL) and Uric Acid(>5mg/dL) may cause the result slightly
higher than the actual glucose level.
5. A red blood cell count (hematocrit) that is either very high (over 70%) or very
low (under 10%) can cause false result.
6. High altitudes above than 2,750 meter (8,800 feet) may affect the test results.
7. Temperatures outside the range of 8°C to 44°C (46.6°F to 111.2°F) may affect
the test results.
8. Do not modify this meter.
9. Do not perform maintenance and servicing when using the meter.
10. Remove the battery if the meter will not be used for a long time.
Limitations:
1.For single-patient use only.
2.For self-testing.
3.For over the counter use.
4.The patient is an intended operator.
NOTE: PLEASE MAKE SURE THAT ALL PRODUCTS LISTED ON THE
“CONTENTS” OF THE BOX ARE CONTAINED IN THE PACKAGE BEFORE
USING THIS SYSTEM. IF YOU FIND ANY IMPERFECTION IN OUR PROD-
9. : appears to indicate memory mode when reading previous results.
10.
CODE
:Code appears to indicate code NO. when ready to test.
11.
THERMOMETER SYMBOL
: Appears when ambient temperature is above
or below the acceptable range needed for testing.
12.
STRIP SYMBOL
: Appears when the test strip is inserted and meter is
ready for blood testing.
GlucoLeader™ Enhance 2 BLOOD GLUCOSE TEST
STRIP
3 1
1 2 3
once twice
1. Aperture: It absorbs the blood from either side of the test strip.
2. Blood Reaction Zone: It must be lled with blood entirely.
3. Meter Contact: The value of the test result will be transmitted from blood Re-
action Zone into the meter through this Meter Contact.
3 1
NOTE 2
NOTE 1
once twice
NOTE 1: NEVER APPLY BLOOD SAMPLE TWICE IN THE SAME STRIP.
PLEASE REPEAT THE TEST USING A NEW TEST STRIP WITH A LARGER
BLOOD DROP.
NOTE 2: IF THE AMOUNT OF BLOOD APPLIED WAS TOO SMALL, AN ER-
ROR 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 SEC-
TION.
IMPORTANT TEST STRIP INFORMATION
1. GlucoLeader System measures the amount of glucose in capillary and ve-
nous whole blood. Blood can be applied to the front of the test strip and is
automatically drawn to the test strip through capillary and venous action.
2. GlucoLeader Blood Glucose Test Strips are intended for in vitro diagnostic
use with capillary and venous whole blood or GlucoLeader Glucose Control
Solution. Results will not be accurate if used with plasma or serum samples.
3. Do not use test strips beyond the expiration date indicated on the strip
vial label.
4. Use test strips within 90 days after rst opening the vial cap. Record the dis-
card date on the vial when you open a new vial of test strips.
5. Blood Glucose Test Strip can be damaged by heat and light. Keep them
sealed in the original vial.
6.
+30
°C
(86
°F
)
+2
°C
(35.6
°F
)
Store test strip in the original container within the range of 50°F to
104°F(10°C to 40°C). Do not refrigerate.
7 . Do not use damaged test strips in any way. Use test strip im-
mediately after taking it out from the vial or foil packet; replace the vial
cap and close it tightly.
8. Do not transfer test strips to a new vial. Always carry test strips in their origi-
nal vial.
9. Do not place in direct heat or sunlight.
10. Do not carry loose test strips in your carrying case.
11. Test strips are for single use only.
GlucoLeader™ GLUCOSE CONTROL SOLUTION
(OPTIONAL)
GlucoLeader™ Glucose Control Solution is used to check if
the GlucoLeader™ Enhance 2 Blood Glucose Meter and Test
Strip are working correctly as a system.
It can be used in two ways:
1. To practice the test procedure
2. To make sure that the GlucoLeader™ Enhance 2
Blood Glucose Meter and Test Strips are working
together properly.
IMPORTANT INFORMATION
1. Do not use glucose control solution beyond the expiration date indicated on
the bottle label.
2. The discard date for glucose control solution is 90 days after rst opening.
Record the discard date on the bottle when you open a new bottle of glucose
control solution.
3. Store the glucose control solution closed at temperatures between
10ºC (50ºF) and 30ºC (86ºF).
PERFORM CONTROL TEST
1. Insert a new test strip into the strip slot, the meter will activate.
2. The last code number will appear on the screen. Compare the code number
shown on the screen against the code number on the test strip vial. If the
two numbers match, you may begin test, otherwise consult Section “CODING
YOUR METER” of this user guide to code your meter rst.
3. Gently shake the glucose control solution and apply a drop to the aperture of
strip. Make sure that the glucose control solution has saturated the blood re-
action zone.
4. Test result will show up in 5 seconds. The result should correspond to the
range printed on the label of strip vial used.
NOTE: REPEAT TEST IF THE RESULT FALLS OUTSIDE THE CONTROL
RANGE. IF YOU CONTINUE TO GET THE RESULT FALLING OUTSIDE THE
CONTROL RANGE, YOUR METER AND STRIP MAY NOT BE WORKING
PROPERLY. DO NOT USE THE SYSTEM TO TEST YOUR BLOOD UNTIL
YOU GET A TEST RESULT FALLS WITHIN THE CONTROL RANGE. CON-
SULT YOUR LOCAL DISTRIBUTOR FOR HELP.
GlucoLeader™ Enhance 2 CHECK STRIP (OPTIONAL)
The GlucoLeader™ Enhance 2 Check Strip can be
used in 2 ways:
1.To check that the meter is operating properly. Use
when performing quality
control check on your meter.
2.To delete all test memories.
How to check meter by check strip
Step 1: Insert the check strip into strip slot with label side up as above.
Step 2: You should obtain an “OK“ reading within 10 seconds,
which means your meter is working properly.
Step 3: Remove the check strip to exit. Meter will automatically turn off.
NOTE: IF YOU DO NOT GET “OK” READING BUT APPEAR OTHER ERROR
MESSAGE, TURN OFF THE METER BY REMOVE CHECK STRIP FROM THE
METER. THEN REPEAT THE TEST. IF THE SECOND RESULT PERSISTS,
CONSULT YOUR LOCAL DISTRIBUTOR FOR HELP.
HOW TO DELETE MEMORY
1. Insert check strip into strip slot with label side up.
2. After “OK” displayed, press Mem button until ashing “dEL” shows up with a
beep sound.
3. Press and hold the Set button until you hear a beep sound, Meter will display
“OK” before turning off and all the memory has been deleted successfully.
4. Remove the check strip from the meter.
SETTING METER PARAMETERS
SETTING TIME & DATE
When you rst time installing the battery into the meter or when replacing a bat-
tery, the meter will automatically enter to the setting mode. Please set correct
time and date before you begin testing.
How to set time and date
1. Press Set button for 2 seconds to turn on the meter. The meter will enter
to the setting mode automatically.
2. At the beep sound, the year ”12” will ash(It mean 2012). Press Set button to
select the desired month.
3. Press Mem button to conrm and shift to the next setting.
4. Repeat above steps to set the day, hour and minute by Set & Mem buttons.
After minute is set, the meter will display “OK” before turning off.
NOTE: WHILE SETTING THE TIME AND DATE, YOU CAN EXIT THE SET-
TING MODE ANYTIME BY PRESS Mem BUTTON FOR 3 SECONDS.
PREPARE FOR BLOOD SAMPLING
ADJUSTABLE LANCING DEVICE
1. Depth Adjustment Cap
2. Depth Selector
3. Lancet Holder
4. Cocking Control
5. Release Button
6. Ejection Button
LANCET
1. Protective cap
Important Information
1. Lancet is for single use only.
2. Keep lancing device and lancets clean.
3. Be cautious when removing the used lancet from the device and when
disposing the used lancet.
4. The lancing device and lancets are in conformity with MDD 93/42/EEC.
Refer to product labels for contact information of manufacturer and CE
marking.
SET LANCING DEVICE
1. Remove the depth adjustment cap. Insert a
lancet into the lancet holder and push down
until it is fully seated
2. Twist off the protective cap until it separates
from the lancet.
3. Replace the depth adjustment cap and set the
puncture depth to the desired number.
NOTE: The shorter the scale the shallower the
puncture.
4. Pull back the cocking control until it makes a
click, press release button for penetration. If it
does not click, the device may have been cocked
when the lancet was inserted. Please contact local
distributor.
UCTS, PLEASE RETURN THE WHOLE SYSTEM TO THE PLACE OF PUR-
CHASE.
BLOOD GLUCOSE METER
Study this diagram and become familiar with all the parts of your GlucoLeader™
Enhance 2 Blood Glucose Meter.
Enhance
Set Mem
1
2
3
4
5
6
7
8
Battery: CR2032, 3V
BR20000000001
3L-XXXXXX V1.4
Enhance 2
GlucoLeader
TM
Blood Glucose Monitoring System
In vitro diagnostic medical device for self testing
FIA Biomed GmbH
Rheiner Strasse 172,
D-48282 Emsdetten, Germany
HMD BioMedical Inc.
No.181 Minsheng St., Xinpu Township,
Hsinchu County, Taiwan (R.O.C.)
1.
DISPLAY
: The large, easy to read display shows the test results, messages,
blood glucose results stored in memory, time and date.
2.
Mem BUTTON
: Press Mem button to enter memory mode to recall the
information stored in meter’s memory.
3.
Set BUTTON
: Press Set button to enter date and time setting.
4.
STRIP SLOT
: Holds a GlucoLeader™ Enhance 2 Blood Glucose Test Strip or
Check Strip in place when you perform blood glucose test or perform check
test.
5.
BATTERY COMPARTMENT
: Holds one 3V Lithium battery. The battery is
not yet installed into meter when new purchasing. Before using the meter,
please install the battery rst.
6.
Meter SN Label
: The label shows the meter serial number and FCC ID.
7.
EJECTION BUTTON
: For a easy ejection of the test strip.
8.
DATA PORT
: Allows you to transfer the information stored in the meter’s
memory to a smartphone to view, analyze. (The smart cable should be pur-
chased separately.)
FCC Regulations:
15.19(a)(3):
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference,
and (2) this device must accept any interference received, including interference
that may cause undesired operation.
15.105(b):
NOTE: This equipment has been tested and found to comply with the limits for
a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a resi-
dential installation.
This equipment generates, uses and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that in-
terference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Exposure to Radio Frequency Radiation
Exposure to Radio Frequency Radiation
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment and meet FCC radio frequency(RF) Exposure Guide-
lines.
This equipment must not be co-located or operating in conjunction with any
other antenna or transmitter.
METER LCD WINDOW
1.
TEST RESULT
2.
DATE
: Month/date.
3.
DAY AVG
: Appears when the meter is in the
memory mode while recalling
7/14/21/28 day test averages.
4.
TIME
: The meter is programmed for a 24 hour
period format.
5.
BATTERY SYMBOL
: Appears when battery is low.
6.
SYMBOL
: When the result is over 320mg/dL(17.7 mmol/L) or
below 70mg/dL (3.9 mmol/L), the symbols will appear and “beeping”
alarms the patients of abnormal glucose level.
7.
mg/dL mmol/L
: The meter has two units of measurement (mg/dL or mmol/L)
to choose from.
8.
SYMBOL:
The test can be adjust and stored into 3 types of test
modes - BEFORE MEAL TEST (AC ), AFTER MEAL TEST (PC ),
and GLUCOSE CONTROL SOLUTION TEST (QC )
GlucoLeader
™
Enhance
Blood Glucose Monitoring System
Enhance
Set Mem
2
3K-02-XXXXXX V3