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Intended Use
The RIGHTEST ALPHA Blood Glucose Monitoring System is designed for
in vitro
diagnostic (for testing
outside the body) use only and can be used by home user and healthcare professional.
The system can test glucose concentration in fresh capillary whole blood (drawn from fingertip, palm
and forearm).
The glucose result displayed is calibrated into the plasma glucose testing equivalent.
The system is not intended for screening or diagnoses of diabetes mellitus.
The
Blood Glucose Test Strip is designed for use only with the
RIGHTEST ALPHA
RIGHTEST ALPHA
Blood Glucose Meter to obtain accurate 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.
2) Pull the cap and hub off in opposite directions, remove the cap.
3) Insert a new disposable lancet firmly into lancet carrier.
4) Twist off and set aside the protective cover of the disposable lancet.
5) Replace the depth adjustable cap.
6) Choose a depth of penetration by rotating the top portion of the depth adjustable cap until the setting
depth matches the window. Settings are based on skin type " " for soft or thin skin;
" " for average skin; " " for thick or calloused skin.
7) Hold the hub in one hand and pull on the plunger in the other hand. The device will be cocked.
Release the plunger, it will automatically move back to its original position near the hub.
Performing a Test
1) Wash your hands with warm soapy water and dry
thoroughly.
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
view window facing up.
Test Result
- Blood glucose test results are shown on the meter as mg/dL or mmol/L, depending on the preset of
your meter.
- 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 Solution GC570 to
check your meter and test strip. If the test result still remains unusually high or low, contact your
healthcare professional 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 manual, contact your healthcare professional immediately.
- The RIGHTEST Meter displays results between 10 and 600 mg/dL or 0.6 and 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 healthcare professional.
- 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 healthcare
professional.
Precautions
- Check the expiration date printed on the strip vial. Do not use expired test strips.
- Close the vial cap immediately after taking test strip out from the vial.
- Do not perform quality control test with expired control solution.
- Do not bend or twist the test strip. Damage of test strip may cause wrong result.
- Do not reuse test strips and lancets.
- Discard the used disposable lancet and strip into an appropriate puncture-proof or biohazard
container.
-
If the RIGHTEST meters or strips are exposed to temperature environments outside the operating
range of 10 - 40°C (50 - 104°F) please wait at least 30 minutes before measurement.
- If you want to purchase new control solutions, please contact your authorized Bionime representative.
Warning
- Keep the test strips or 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
- The meter readings of the blood glucose may be significantly lower than " true glucose levels " in the
hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested by
the RIGHTEST System, or tested with extreme caution.
- Caution is advised in the interpretation of glucose values 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 at periodic
intervals. To accomplish this, it is recommended that BGM results be compared with a concurrently
obtained laboratory measurement on the same blood sample. A well characterized clinical laboratory
method employing hexokinase or glucose oxidase should be used as the comparative method.
- Flouoride should not be used as a preservative when collecting blood glucose samples.
- Hands or fingers contaminated with sugar from foods or beverages may cause false 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
Test Strips.
- RIGHTEST Blood Glucose Test Strips are designed for use with capillary whole blood samples.
Do not use serum or plasma samples.
- Incorrect test results may be obtained at high altitude more than about 3,048 meters (10,000 feet)
above sea level.
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4) While the blood drop
symbol is flashing, you
are ready to apply the
blood sample within 2
minutes.
5) Place the lancing device
against the pad of your fingertip and press the release button.
9) To remove the lancet, pull off the depth adjustable cap of
lancing device. Without touching the used disposable lancet,
stick the lancet tip into the protective cover. Hold the release
button of lancing device in one hand and pull on the plunger
in the other hand will safely eject the used disposable lancet
into an appropriate puncture-proof or biohazard container.
Please take a minimum of 0.75
μ
L to do the test on
glucose monitoring system. Blood sample size
above 3.0
μ
L might contaminate the meter.
Sample Size Example
For more information on how to use your meter,
lancing device and understand your test results,
see the User's Manual.
6) Touch and hold the drop to the edge of sample entry until you hear a "beep" (if volume is turned on)
and the View Window is totally filled with blood. If the View Window is not totally filled with blood or
the test does not start, please discard the test strip and repeat the test with a new test strip.
7) You will see the countdown mode on the screen. After 5 seconds, the test result appears.
8) Remove the test strip from the meter. Please follow the local regulation and discard the used strip
properly.
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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
Alternative site testing-palm or forearm blood sampling
- To perform a test using samples obtained from alternative sites,
install the
clear cap on the lancing device (For more information on how to install, see
the Instructions for the lancing device).
- To increase the blood flow, massage the puncture area of palm or forearm
for a few seconds.
-
Immediately after massaging the puncture area, press and hold the lancing
device with the clear cap against palm or forearm.
- Then press the release button.
- Continue holding the lancing device against palm or forearm and gradually
increase pressure for a few seconds until the blood sample size is sufficient
(Refer to Instructions for the lancing device).
Releasing
button
Pressing for
a few seconds
Palm
Forearm
Rotate
ALPHA BLOOD GLUCOSE TEST STRIP INSERT
0.75
1.0
3
μ
L
μ
L 1.5
μ
L 2.0
μ
L .0
μ
L
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