Precautions
- Check the expiration date printed on the test strip vial. Do not use expired test strips.
- Close the test strip vial immediately after taking test strip out from the vial.
- Do not perform a control solution test with expired control solution.
- Do not bend or twist the test strip. A damaged test strip may cause incorrect test results.
- Do not reuse test strips and lancets.
- Discard the used disposable lancet and strip into an appropriate puncture-proof or biohazard container.
- If the
is exposed to a significant change in temperature, please wait
RIGHTEST GT200 Blood Glucose Monitoring Meter
at least 30 minutes before performing a test.
- If you want to purchase new control solutions, please contact your authorized Bionime representative.
Warning
- Keep the test strips and vial cap away from children; they may cause a choking hazard. If a test strip or vial cap is swallowed,
contact your Physician immediately.
Limitations
- Blood glucose meter readings may be significantly lower than " true glucose levels " in a hyperglycemic-hyperosmolar
state, with or without ketosis. Critically ill patients should not be tested by the RIGHTEST GT200 Blood Glucose Monitoring
System, or if they are, they should be tested with extreme caution.
- Caution is advised when glucose values are below 50 mg/dL (2.8 mmol/L) or above 250 mg/dL (13.9 mmol/L) Consult a
Physician as soon as possible, if values in this range are obtained.
- Healthcare professionals should evaluate their technique and their patients' technique regarding the use of the RIGHTEST
GT200 Blood Glucose Monitoring System regularly. To accomplish this, it is recommended that blood glucose monitoring
results be compared with a concurrently obtained laboratory measurement on the same blood sample. A proven clinical
laboratory method employing hexokinase or glucose oxidase should be used as the comparative method.
- Fluoride should not be used as a preservative when collecting blood glucose samples.
- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated results.
- The results of blood glucose measurements are different for measurements with whole blood and plasma.
- Storage of strips near bleach as well as bleach containing products will affect the results of the RIGHTEST GT200 Test Strips.
- RIGHTEST GT200 Test Strips are designed for use with whole blood samples. Do not use serum or plasma samples.
- Inaccurate test results may be obtained at altitudes greater than 3,048 meters (10,000 feet) above sea level.
- Venous, arterial, and neonatal blood testing is limited to healthcare professional use only.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- Do not perform the blood glucose test at temperatures below 6°C (43°F) or above 44°C (111°F), nor below 10% or above
90% relative humidity.
Test Result
- Blood glucose test results are shown on the meter as mg/dL or mmol/L.
- If your blood glucose result is unusually high or low, or if you question your results, repeat the test with a new test strip.
You can also run a Quality Control Test with the RIGHTEST Control Solutions GC700 to check your meter and test strip.
If the test result still remains unusually high or low, contact your Physician or the nearest Emergency Health Care
Services immediately.
- If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all
the instructions in this insert, contact your Physician or the nearest Emergency Health Care Services immediately
.
- The RIGHTEST GT200 Blood Glucose Monitoring Meter display results between 10 and 600 mg/dL
(0.6-33.3 mmol/L). If
your test result is below 10 mg/dL
(0.6 mmol/L) , " Lo " will appear on the screen. Please repeat your test with a new
strip. If you still get a " Lo " result, you should immediately contact your Physician or the nearest Emergency Health Care
Services.
- If your test result is above 600 mg/dL
(33.3 mmol/L) , " Hi " will appear on the screen. Please repeat your test with a new
strip. If you still get a " Hi " result, you should immediately contact your Physician or the nearest Emergency Health Care
Services.
6) Touch and hold the drop to the edge of sample port until you hear a " beep " (if volume is turned on) and the sample
window is completely filled with blood. If the view window is not completely filled with blood the test will not start. If this
is the case, discard the test strip and repeat the test with a new test strip.
7) The countdown mode will begin on the display window. After 5 seconds your test result will appear.
8) Remove the test strip from the meter. Please follow your local regulations to properly discard the used strip.
9) To remove the lancet, pull off the depth adjustable cap of the lancing device. Without touching the used disposable
lancet, insert the lancet tip into the protective cover. Hold the release button of the lancing device in one hand and pull
on the plunger with the other hand to safely eject the used disposable lancet into an appropriate puncture-proof or
biohazard container.
6
7
For more information on how to use your meter and understand your test results, see the RIGHTEST GT200
User’s Manual.
BLOOD GLUCOSE TEST STRIP GT200 INSERT
Intended Use
The RIGHTEST GT200 Blood Glucose Monitoring System is to be used by:
- Professionals needs to monitor the glucose level of patient or potential person. Sample sites include capillary, venous,
arterial and neonatal whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the
case of neonates, the heel.
- Any person with diabetes, for monitoring their glucose levels in capillary whole blood (CB) from the fingertip, palm and
forearm;
- A single user to aid in the management of diabetes at home.
RIGHTEST GT200 Blood Glucose Test Strips:
- Are intended for testing outside the body (
in vitro
diagnostic use for self-testing only).
- Are designed for use only with RIGHTEST GT200 Blood Glucose Monitoring Meter to assure accurate results.
RIGHTEST GT200 Blood Glucose Monitoring System includes meter, test strips, control solutions, lancing device and
lancets.
Special conditions for use statement(s): RIGHTEST GT200 Blood Glucose Monitoring System provides plasma equivalent
results.
Test Procedure
Preparing the Lancing Device
1) Hold the depth adjustable cap in one hand and hold the hub in the other hand. Bend the cap towards the down side, until
a gap appears between the cap and hub. Pull the cap and hub off in opposite directions, remove the cap.
2) Insert a new disposable lancet firmly into lancet carrier.
3) Twist off and set aside the protective cover of the disposable lancet.
4) Replace the depth adjustable cap.
5) Choose a depth of penetration by rotating the top portion of the depth adjustable cap until your desired setting is visible
in the window. Settings are based on skin type: " " for soft or thin skin; " " for average skin; " " for thick
or calloused skin.
6) Hold the base in one hand and pull on the plunger with the other hand. The device will be cocked. Release the plunger
and it will automatically move back to its original position near the base.
Performing a Test
1) Wash your hands in warm soapy water and dry.
2) Take one test strip from the vial. Close the vial cap immediately.
3) Insert the strip into the strip port of the meter with the sample window facing up. Push the strip in until it clicks and
stops. The meter will automatically detect the code number.
4) When the blood drop icon flashes on the display window, blood sample is ready to be applied to the test strip port
(apply within 2 minutes).
5) Place the lancing device to your fingertip and press the release button.
1
Please use a minimum blood drop size of 0.75
µL
to perform
the test on glucose monitoring system. Blood drop sizes
greater than 3.0
µL
are too large and may contaminate the
test strip port of the meter.
Sample Size Example
5
1
2
3
4
5
6
Alternate site testing: palm or forearm blood sampling
- To perform a test using samples obtained from alternate sites, choose the
clear cap and follow the steps above.
- Massage the intended puncture area of your palm or forearm for a few
seconds.
-
Immediately after massaging the area, press and hold the lancing device
with the clear cap against your palm or forearm.
- Press the release button.
- Continue holding the lancing device against your palm or forearm and
gradually increase pressure for a few seconds until the blood sample size is
sufficient.
(For more information on how to install the clear cap on the Lancing device,
please refer to the Lancing Device instructions)
- DO NOT test on the palm or forearm if you are testing for hypoglycemia (low
blood glucose).
Releasing
button
2
4
3
0.75
.0
3
µL
1
µL
1.5
µL
2.0
µL
.0
µL
8
Rotate
(1)
Expected values
GLUCOSE LEVEL
From 70 to 99 mg/dL (3.9 to 5.5 mmol/L)
From 100 to 125 mg/dL (5.6 to 6.9 mmol/L)
126 mg/dL (7.0 mmol/L) and above on more than one testing occasion
INDICATION
Normal fasting glucose
Pre-diabetes (Impaired fasting glucose)
Diabetes
Fasting Blood Glucose
TM
Pressing for
a few seconds
Palm
Forearm
