Rightest Max Manual

Intended Use

RIGHTEST Max and Max Plus Blood Glucose Monitoring Systems are used by individuals with diabetes. It's for
checking on glucose levels in 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. It's as an aid in
management of diabetes at home and clinical sites.
RIGHTEST Max Blood Glucose Test Strips were designed for self-testing outside the body (in vitro diagnostic
use).
The RIGHTEST Blood Glucose Monitoring System aids to diabetes control, could be used by healthcare
professionals in clinical setting, also by people to use at home.
The RIGHTEST System tests whole blood samples, and provides results equivalent to plasma results of the
laboratory instrument.
The RIGHTEST Max Blood Glucose Test Strip is designed for the following meters to obtain accurate results:
RIGHTEST Max Blood Glucose Meter
RIGHTEST Max Plus Blood Glucose Meter

Test Procedure

Preparing the Lancing Device
Wash your hands with warm soapy water and dry thoroughly before you start the test.
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) The adjustable cap with 7 depth levels allows you to select the depth of penetration by rotating the
cap until the preferable depth display in the window. Settings are based on skin type "
thin skin; " " for average 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.
1 2
Performing a Test
1) Take one test strip from the vial. Re-cap the vial cap
immediately.
2) Insert the test strip into the test strip port of the meter with
the indication symbol facing up.
3) While the blood drop symbol is flashing, you are ready to
apply the blood sample within 2 minutes.
3
4) Place the lancing device against the pad of your fingertip and press the release button.
5) 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.
Sample Size Example
0.75 μL 1.0 μL
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).
6) You will see the countdown mode on the screen. After 5 seconds, the test result appears.
7) Remove the test strip from the meter. Please follow the local regulation and discard the used strip
properly.
6
For more information on how to use your meter, lancing device and understand your test results,
see the User's 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 RIGHTEST Max 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.
- 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.
(1)
Expected values
Fasting Blood Glucose
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

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 RIGHTEST Meter and Test Strips are exposed to temperature environments out of operating range–
below 6°C (43°F) or above 44°C (111°F)– please wait 30 minutes before testing again.
- 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 to compare the meter result with a laboratory result
using the same blood sample. A well characterized 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 false elevated results.
- The results of blood glucose measurements are different for measurements with whole blood and
plasma.
MAX BLOOD GLUCOSE TEST STIRP INSERT
3
4
1.5 μL 2.0 μL
7
8) To remove the lancet, pull off the depth adjustable cap of
" for thick or calloused skin.
4 5
5
Please take a minimum of 0.75 μL to do the test on
3 .0 μL
glucose monitoring system. Blood sample size
above 3.0 μL might contaminate the meter.
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.
6
1
Palm
Pressing for
a few seconds
INDICATION
Normal fasting glucose
Pre-diabetes (Impaired fasting glucose)
Diabetes
" for soft or
7
2
Forearm
Releasing
button