Rightest
™
GS260
BLOOD GLUCOSE TEST STRIP INSERT
Intended Use
The
Blood Glucose Monitoring System is used by diabetics.
It's for checking on glucose levels in capillary whole blood (CB) from the fingertip, palm and forearm.
It's as an aid in management of diabetes at home and clinical sites.
Rightest™
Blood Glucose
Test Strips are intended for testing outside the body (in vitro diagnostic use for self-testing
only).
Rightest™
Blood Glucose Test Strip GS260 is designed for use only with
Rightest™
Blood Glucose Meter GM260
.
Rightest™
Blood Glucose Monitoring System includes meter, test strips, control solutions, lancing device and lancets.
Special conditions for use statement(s):
Rightest™
System provides plasma equivalent results.
Rightest™
to
get accurate results
Test Procedure
Preparing the Lancing Device
1) Pull off the depth adjustable 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 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.
6) 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. Re-cap the vial cap immediately.
3) Insert the strip into the strip port of the meter with the indication symbol facing up. Push the strip in until it snaps
and stops. The meter will turn on automatically.
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.
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.
- Do not reuse lancets. Discard used lancets properly.
Rightest™
Limitations
- Grossly lipemic ( fatty ) samples may influence the test results. Knowing such interferences, patients under the
supervision of their
should have baseline glucose values set up by a clinical lab method
before the start of glucose monitoring at home. These baseline values should be checked regularly.
- 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 when glucose values are below 50 mg/dL (2.8 mmol/L) or above 250 mg/dL (13.9 mmol/L).
Consult a
as soon as possible if values in this range are obtained.
- Hands and 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 3048 meters (10000 feet) above sea level.
-
If the
meters and strips are exposed to a high temperature difference, please wait 30 minutes before
measurement.
- If you want to purchase new control solution, please contact your authorized Bionime representative.
- The glucose test results of blood samples taken from different sites might be varied in certain conditions such as
your glucose is changing rapidly following a drink, a meal, an insulin dose or exercise. In these cases, only fingertip
should be used.
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 healthcare professional instantly.
healthcare professional
healthcare professional
,
- Healthcare professionals should evaluate their technique and their patients' technique at periodic intervals. To
accomplish this, it is recommended that product 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.
1
Please take a minimum of 0.75 L to do the test on glucose
monitoring system. Blood sample size above 3.0 L might
contaminate the test strip port and the meter.
µ
µ
Sample Size Example
For more information on how to use your meter and understand your test results, see the User manual.
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 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.
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.
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.
5
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 lancing
device manual).
- 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
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 Instruction manual for the lancing device )
clear cap
Releasing
button
Pressing for
a few seconds
4
8
(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
Impaired fasting glucose (pre-diabetes)
Diabetes
Fasting Blood Glucose
6
5
4
3
2
1
b
1
a
2
3
6
7
0.75µL 1.0µL
µL
µL
3 µL
1.5
2.0
.0
