Blood Glucose Monitoring System
For in vitro diagnostic use only.
INTENDED USE
Blood Glucose Monitoring System is intended to be used for the quantitative measurement
of glucose (sugar) in fresh capillary whole blood from fingertip, palm, up-per arm, or forearm.
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. This system
should not be used for the diagnosis of or screening for diabetes. Alternative site testing
should be done only during steady- state times (when glucose is not changing rapidly).
PRINCPLE OF THE USE
Blood Glucose Test Strip is designed with an electrode that measures glucose levels. Glucose in
the blood sample mixes with reagent on the test strip that causes a small electric current. The
amount of current that is created depends on how much glucose is in the blood. The meter
measures the current that is created and converts the measurement to the amount of
glucose that is in the blood. The blood glucose result is displayed on the screen. By touching a
drop of blood to the tip of the test strip, the strip’s reaction chamber automatically draws
the blood into the strip through capillary action. When the chamber is full, the meter
starts to measure the blood glucose level. It is a simple and practical system for the daily
monitoring of your blood glucose level.
REAGENT COMPOSITION
Active Ingredient (per 100 strips)
Glucose oxidase (GOD) 300 units .
Potassium ferricyanide (mediator) 9.0 mg.
MATERIALS PROVIDED
Blood glucose monitoring system (including glucose test, lancing device and lancet).
Package insert.
METER SET UP
You should check and update the meter settings such as time and date before using your
meter or after changing the meter battery.
The Strip Stand-by screen appears on the display when the ON/OFF button is pressed.
Press and hold for 3 seconds on the strip Standby screen to enter the SET mode. You will
see the audible beep set mode at the first.
STEP-1: Setting the Audible Beep
1.
Press the ON/OFF buttons in the test strip waiting screen for 3 seconds, and then the
beep sound setting screen appears, which is the first stage of setting of a meter.
2.
Set the beep mode on or off by pressing the left or right button and then confirm the
preferred feature by pressing the ON/OFF button. When the audible signal is activated, a
beep is generated; otherwise, if you select the beep off feature, no sound is made.
Step-2: Setting the date and time
Date Setting
1.
Set the correct year by pressing either the left or right button and then confirm the
correct year by pressing the ON/OFF button.
2.
The display to set the month and day format. The glucose meter can display the
date in the Month-Day (m-d) format or Day-Month (d-m) format. Set your
preferred format on the display by pressing the left or right button and then confirm
the selection with the ON/OFF button.
3.
The display to set the date will appear next. Set the correct month and day on
the display by pressing the left or right button and confirming the selection with
the ON/ OFF button.
Time Setting
1.
The screen to set the time format will be displayed next. The glucose meter can display
the time in the 12 hour or 24 hour format. Set your preferred format on the display by
pressing the left or right button and con-firm the selection with the ON/OFF button.
4.
The display to set the time will appear next. Set the correct time on the display by
pressing the left or right button and confirm the selection with the ON/OFF button.
[Setting date] [Setting time]
Meter Set up
PRECAUTION AND WARNING
1.
This system is not designed to be a substitute for pathology laboratory equipment
and should not be used for the diagnosis of diabetes.
2.
Do not use this system to test neonates. It has not been validated for neonatal use.
3.
Never make significant changes to your diabetes control program or ignore physical
symptom without consulting with your healthcare professional.
4.
Do not use this device to measure blood glucose in people who are experiencing
cardiovascular collapse (severe shock) or decreased peripheral blood flow.
5.
Keep the test strip slot free of dust.
6.
If the glucose meter is stored with the battery in, keep it in a low humidity room.
7.
Using other test strips can cause inaccurate the result.
8.
After removing a test strip, close the container tightly.
9.
Do not expose strips to heat, moisture or humidity. Temperatures outside the range
indicated above as well as humidity (as found, for example, in the bathroom, kitchen,
laundry room, car, or garage) can damage the strips and lead to inaccurate results. Severe
humidity condition (≥90%, ≤15%) may affect the result.
10.
Store test strips in their original container only to avoid damage or contamination. Do
not transfer the test strips to any other container and do not store them outside their
original container.
11.
Do not use test strips from any container that is damaged or left open to air.
12.
When you first open the container, write date when the container was first opened on
the container’s label. Dispose of the test strips after 6 month from date the container
was first opened.
13.
Do not use the test strips past their expiry date (printed on the package) or disposal
date, whichever comes first. Utilizing expired test strips or strips whose container has
been open for over six months can lead to inaccurate results.
14.
Blood Glucose Test Strips are for a single use only. Never re-use a test strip to which
blood or a control solution have already been applied.
15.
Pay attention not to contaminate the test strip with dirt, food or liquids. You can touch
the test strip over its entire surface with clean and dry hands.
16.
Do not bend, cut, or alter in any way the test strip.
17.
Use only fresh capillary blood. Do not use serum or plasma or venous whole blood.
18.
Severe dehydration (excessive water loss) may cause false low results. If you believe
you are suffering from dehydration, consult your healthcare professional right away.
19.
Extremes in hematocrit may affect test results. Hematocrit levels less than 20% may
cause falsely high readings. Hematocrit levels greater than 60% may cause falsely low
readings. If you do not know your HCT, ask your doctor.
20.
Interfering substances: the following compounds, elevated levels of ascorbic acid, uric
acid, acetaminophen, total bilirubin and triglycerides may affect results.
Material
Limitation
Acetaminophen
> 6mg/dL
Ascorbic Acid
> 4mg/dL
Bilirubin
> 40mg/dL
Total cholesterol
> 506mg/dL
Creatinine
> 30mg/dL
Dopamine
> 5mg/dL
EDTA
> 0.1mg/dL
Galactose
> 60mg/dL
Gentisic Acid
> 1.8mg/dL
Glutathione
> 4.6mg/dL
Hemoglobin
> 200mg/dL
Heparin
> 3,000U/L
Ibuprofen
> 50mg/dL
Levodopa
> 4mg/dL
Maltose
> 60mg/dL
Methyl-Dopa
> 2mg/dL
Sodium Salicylate
> 20mg/dL
Tolazamide
> 8.4mg/dL
Tolbutamide
> 4mg/dL
Triglycerides
> 1,026mg/dL
Uric Acid
> 9mg/dL
Xylose
> 60mg/dL
Pralidoxime Iodide
> 1.3mg/dL
Icodextrin
> 750mg/dL
Metformin
> 4mg/dL
Fructose
> 16.5mg/dL
Mannitol
> 810mg/dL
Warfarin
> 1.1mg/dL
21.
The needle of lancet is sharp, keep the lancet away from children.
22.
Keep the lancet and lancing device dry and avoid their direct exposure to sunlight,
intense heat and high humidity areas.
23.
The lancet must be used for any purpose other than capillary blood sample
collection.
24.
The lancet is for single use only. Do not reuse it.
25.
Check the conditions of packaging before use; do not use the product in case of
anomalies.
26.
If a lancet cap is loosed or needle of a lancet is exposed, you should not use it.
27.
Dispose of used lancets in order to reduce the risk of infection.
PROCEDURE
1. Blood Collection procedure
Store at 2-32°C
3. Screw the device’s cap back on
4. Adjust the pricking depth by rotating the comfort
dial. The dial includes positions from 1 to 5. The
lowest depth is ideal for delicate skin and
pediatric use, the highest depth is ideal for think
and calloused skin.
1. Unscrew the cap of lancing
device to remove it.
2. Insert the lancet into the lancing device holder
and push down firmly until it is fully engaged. Twist
the lancet cap until it separates from the lancet.
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