SIDE
1
2
Before You Begin
PLEASE READ THIS BEFORE USING.
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near children,
handicapped persons or invalids.
2. Use the device only for the intended use described in this User Guide.
3. Do not use test strips and control solutions which are not supplied by the
manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered any damage.
5. Before using any product to test your blood glucose, read all instructions
thoroughly and practice the test. Do all quality control checks as directed and
consult with a diabetes healthcare professional.
6. KEEP THIS USER GUIDE WITH YOU.
Intended Use
The system is intended for use outside the body (
in vitro
diagnostic use only).
It should be used only for testing blood glucose (blood sugar) and only with fresh
capillary whole blood samples. The system is intended for use in the home and in
clinical settings. It should not be used for the diagnosis of diabetes or for the testing of
newborns.
Principle of Measurement
Blood glucose is measured by an electrical current that is produced when a blood
Getting To Know Your System
The Medicare Blood Glucose Monitoring System-LiS
The Medicare System-LiS system uses the latest technology to provide you with
easy and comfortable testing. The system requires only a 0.3 μL of blood sample to
complete the testing in only 6 seconds.
samples mixes with the reagent (special chemicals) of the test strip. The electrical
current changes with the amount of glucose in the blood sample. The Medicare System-
LiS meter measures the strength of the electrical current, calculates your blood glucose
level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or
millimoles of glucose per liter (mmol/L).
Caution
1. The user should not take any decision of medical relevance without first consulting
his or her medical practitioner.
2. Call your doctor immediately if you experience symptoms that are not consistent with
your blood glucose test results.
3. High altitudes above than 3,402 meter (11,161 ft) may affect the test results.
4. Temperatures outside the range of 5°C to 45°C (41°F to 113°F) may affect the test
results. Do not test beyond of temperature range.
IMPORTANT HEALTH-RELATED INFORMATION
1. Apply only capillary whole blood sample to test your blood glucose. Applying other
substances or plasma, serum will cause wrong results.
2. Severe dehydration and excessive water loss may cause false low results. If
you believe you are suffering from severe dehydration, consult your healthcare
professional immediately.
3. Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high
blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or
above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below
60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare
professional immediately.
4. Inaccurate results may occur in severely hypotensive individuals or patients
in shock. Inaccurate low results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients
should not be tested with blood glucose meters.
5. Abnormal red blood cell counts (hematocrit level below 20% or above 60%) may
cause false results. Please consult your healthcare professional if you do not know
your hematocrit level.
6. Interference: Reducing substances occurring in the blood naturally (uric acid,
bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will
not significantly affect Medicare System-LiS test results. However, elevated
concentrations of these substances may affect test results. The compounds listed
in the tables were found to have no affect at the concentration indicated.
Compounds
Highest concentrations
tested at which no
interference occured
Compounds
Highest concentrations tested
at which no interference
occured
Acetaminophen
≦
8.0 mg/dL (0.53 mmol/L) Gentisic Acid
≦
5.0 mg/dL (0.32 mmol/L)
Ascorbic Acid
≦
5.0 mg/dL (0.28 mmol/L) Hydroxyurea
≦
3.0 mg/dL (0.39 mmol/L)
Aspirin
≦
60 mg/dL (3.33 mmol/L)
L-dopa
≦
10 mg/dL (0.51 mmol/L)
Bilirubin
≦
90 mg/dL (1.54 mmol/L)
Maltose
≦
900 mg/dL (26.3 mmol/L)
Cholesterol
≦
500 mg/dL (12.9 mmol/L) Methyldopa
≦
3.0 mg/dL (0.13 mmol/L)
Creatinine
≦
5.0 mg/dL (0.44 mmol/L) Tolbutamide
≦
400 mg/dL (14.8 mmol/L)
Dopamine
≦
2.0 mg/dL (0.11 mmol/L) Triglycerides
≦
2,000 mg/dL (22.6 mmol/L)
Galactose
≦
900 mg/dL (50 mmol/L)
Uric Acid
≦
8.0 mg/dL (0.48 mmol/L)
REFERENCE:
* 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.
* 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.
1.
DATE:
Display year, month and date.
2.
TIME:
The meter is programmed for a 12
hour period format.
3.
AVERAGE:
Appears when the meter is in the
memory mode while recalling 7/14/28 day test
averages.
4.
MEMORY SYMBOL:
Appears when in the
memory mode.
5.
THERMOMETER SYMBOL:
Appears when
ambient temperature is above or below the
acceptable range needed for testing.
6.
CONTROL SOLUTION TEST SYMBOL:
Appears when you are in Control Solution
Mode. Your test result will not be stored in
meter memory.
7.
UNIT OF MEASURE:
Appears with the test result either in mg/dL or mmol/L.
8.
BATTERY SYMBOL:
Appears when battery is weak.
9.
BLOOD DROP SYMBOL:
Flashes when sample should be applied.
10.
STRIP SYMBOL:
Appears when the meter is turned on and waiting for inserting a
test strip.
1.
A
1
. Getting To Know Your System
2. Prepare For Blood Sampling
3. Performing Blood Test
4. Understanding Your Test Result
5. Memory Recall
6. Control Solution Testing
7. Caring For Your Meter And Test Strip
8. System Specifications
9. Display Messages And Problem-Solving Guide
SIDE
A :
SIDE
B :
Test Strip
ABSORBENT
CHANNEL:
Apply a drop of
blood here.
CONTACT BARS:
Insert this end into strip slot.
TEST STRIP HANDLE :
Hold this part to insert the test strip
into the meter slot.
CONFIRMATION WINDOW:
This is where we confirm if enough blood is applied for the
test. Ensure that it is fully covered with blood sample.
For
In vitro diagnostic use
Temperature limitation / Store at
Please consult instructions for use
Use by /Expiry date
Do not reuse
Manufacturer
Lot number
Caution, consult accompanying document
Keep dry
Keep away from sunlight
Humidity limitation
EU representative.
This product fulfils the requirements of Directive 98/79/EC in vitro diagnostic medical device.
Performance Characteristics:
Accuracy:
≧
95% of the individual glucose results fell within ± 15 mg/dL(0.83 mmol/L) at glucose concentration <
75 mg/dL(or 4.2 mmol/L) and within ± 20% at glucose concentration
≧
75 mg/dL(or 4.2 mmol/L), compared with
glucose analyzer YSI 2300.
PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%.
1
2
3
4
5
6
7
9 8
10
REPLACING THE BATTERY
1.The meter comes with ONE Lithium battery (battery type CR2032).
2.Battery life will vary depending on usage, so always keep a spare battery on hand.
The battery should last about 1000 tests or 12 months when testing 3 times a day.
3.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.
4.When battery symbol appears together with E-b on the display, the meter will no
longer give results and you must replace the battery immediately. Please always have
one spare battery with you to ensure that you can replace the battery anytime.
How to replace the battery
J7
1. Make sure the meter is turned off. Let the front of the meter
rest in the palm of your hand. Press the buckle on the battery
cover and lift up to open the cover. Remove the battery.
J7
2. With the plus (+) side up, place the battery (battery type
CR2032) in the compartment and slide it upwards until it is
locked into place. You should hear a beep to indicate the
battery installed correctly. If not, please replace the battery
correctly.
J7
3. Close battery cover.
NOTE:
1. Replacing the battery does not affect the test result stored in memory. However the
time and date may need to re-set.
2. As with all small objects, the battery should be kept away from small children as a
safety precaution. If the battery is swallowed, see medical assistance immediately.
3. Batteries might leak chemicals if not used for a long time. Remove the batteries if
you are not going to use the device for 3 months or more.
4.
Please discard the product or the batteries properly according to the regulations
of your country.
SETTING YOUR METER
Please install battery first and set to correct settings before you begin to test.
J7
STEP 1. Enter Setting Mode
Start with the meter off. Open the battery compartment, and press SET
BUTTON. The meter will turn on and enter the setting mode.
STEP 2. Set the Year
The year appears with the number flashing. Press and release the M
BUTTON to obtain the desired year. Press SET BUTTON to confirm
and move to next MONTH setting.
STEP 3. Set the Month
The month appears with the number flashing. Press and release the M
BUTTON to obtain the desired month. Press SET BUTTON to confirm
and move to next DATE setting.
STEP 4. Set the Date
The date appears with the number flashing. Press and flash the M
BUTTON to obtain the desired date. Press SET BUTTON to confirm
and move to next HOUR setting.
STEP 5. Set the Hour
The hour appears with the number flashing. Press and release the M
BUTTON to obtain the desired hour. Press SET BUTTON to confirm
and move to next minutes setting.
STEP 6. Set the Minute
The minute appears with the number flashing. Press and release the M
BUTTON to obtain the desired minute. Press SET BUTTON to confirm
and the meter will enter to next unit setting.
STEP 7. Set the Unit of Measurement
The existing unit (for example mg/dL) will appear and flash. You can
choose to reset measurement unit. If you do not want to change unit,
press SET BUTTON to skip this step. If you want to change unit, press
and hold the M BUTTON for 3 seconds to change the unit to mmol/L.
Press SET BUTTON to confirm and the meter will enter to next setting.
STEP 8. Delete Memory
When the dEL symbol and the flashing memory symbol appear on the
display, you can choose to clear the memory. If you do not want to clear
the memory, press the SET BUTTON again to skip this step. If you want
to clear ALL memory, press and hold M BUTTON for 4 seconds. The “--
-“ image will appear on the LCD screen to indicate that all memory has
been deleted.
STEP 9. Complete Setting
After delete memory, the meter will display “OFF” before shut down.
The meter setting is now completed
IMPORTANT :
1.
The time, date and unit of measurement can ONLY be changed in the setting mode.
Therefore, when you perform a blood glucose testing, it is not possible to change those
parameters.
2.
Your meter displays 7, 14 and 28-day averages which you can access from the meter
memory. These averages are calculated from your latest result obtained during the last 7,
14 and 28 days.
3.
Your meter can display test result in milligram per deciliter (mg/dL) or millimoles per liter
(mmol/L). The mg/dL unit is standard in the United States. The mmol/L unit is standard
in Canada and European countries. Your meter has been preset at the factory with the
standard unit measurement used where you live. When you turn off the meter or replace
the battery, the unit will not be changed.
4.
Use of the wrong unit of measure may cause you to misinterpret your blood glucose
level, and may lead to incorrect treatment. Please always consult with your healthcare
professionals before you reset the unit of measure.
BLOOD GLUCOSE
MONITORING SYSTEM
BG - 101
USER GUIDE
J7
MC14EL005001
Model Name: BG-101
OK Biotech Co., Ltd.
Hsinchu, Taiwan
10-62-3463-0003
V1-JUL11
Meter
DISPLAY :
The large, easy to
read display shows
test results, messages,
test results stored in
memory.
STRIP SLOT :
Insert the test strip here. The meter will
turn on automatically.
METER LABEL:
Each meter has its unique number on it. It can be
used when you want to obtain warranty service.
Please do not alter or tear the label off.
M BUTTON:
Main button, press button to turn the meter on
or perform other functions described in this User
Guide.
SET BUTTON:
Located in
the battery
compartment; press
button to enter
meter setting. Refer
to “SETTING YOUR
METER” section of
this user guide for
details.
BATTERY COMPARTMENT :
Holds one 3V Lithium battery (CR2032).
Protective cap
Lancet
Important Lancing Device and Lancets Information
1. Lancet is for single use only.
2. Keep lancing device and lancets clean.
3. Use caution when removing the used lancet from the device and when disposing the
used lancet.
IMPORTANT :
The meter and lancing device are for single patient use.
Do NOT share them with anyone including other family members !
Do NOT use on multiple patients !
Setting your Lancing Device
1. Screw off the cap of lancing device. 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.
4
5
3.Replace the lancing device cap and set the
puncture depth to the desired number.
NOTE: THE DEPTH SELECTOR OFFERS 5 LEVELS OF SKIN
PENETRATION:
1-2 FOR SOFT OR THIN SKIN
3 FOR AVERAGE SKIN
4-5 FOR THICK OR CALLOUSED SKIN
1
2
4. Pull back the sliding barrel until it makes a click,
and then release. If it does not click, the device
may have been cocked when the lancet was
inserted.
Prepare For Blood Sampling
Adjustable Lancing Device
Your lancing device and lancets are used for obtaining
capillary blood samples from the puncture site.
2
.
Lancet Holder
Lancing
Device Cap
Depth Selector
Release Button
Lancet Ejector
Sliding Barrel
OK Biotech Co., Ltd.
No. 91, Sec. 2, Gongdao 5th Road,
30070 Hsinchu City, TAIWAN
www.okbiotech.com
MDSS GmbH
Schiffgraben 41, 30175 Hannover, GERMANY
L-Tac MediCare Pte Ltd
25 Mandai Estate #07-11
Innovation Place Tower 1
Singapore 729930
Tel: +65 6334 2273
Fax: +65- 6863 8190
www.medicare-l-tac.com.sg
10-62-3412-0003 V2-JUL15
