Rightest GS100 User manual

Intended Use
The Blood Glucose Monitoring System is used by individuals with diabetes.
Rightest™ test Strips are intended for testing outside the body ( diagnostic use) (For self-
testing) only.
The Rightest™ System tests the CB and provides results equivalent to a laboratory instrument.
(plasma equivalent)
- The Rightest™ is designed for use only with the Rightest™ Blood Glucose
- The Rightest™ Blood Glucose Monitoring System includes meter, test strips, control solutions, lancing device
and lancets.
Rightest™
in vitro
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. Please only purchase the test strips in
your country, the use of the test strips of different countries is not suggested and might get deviated test
results under such circumstance.
Blood Glucose
Blood Glucose Test Strip GS100
Meter GM100.
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.
Test Result
- Blood glucose test results are shown on the meter as mg/dL.
- 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 your Rightest™ Control Solutions to check your meter
and strip. If the test result still remains unusually high or low, contact your doctor 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 doctor immediately.
- The Rightest™ Meter displays results between 0.6 and 33.3 mmol/L. If your test result is below 0.6 mmol/L,
" Lo " will appear on the screen. Please repeat your test again with another strip. If you still get a " Lo " result,
you should immediately contact your doctor.
- If your test result is above 33.3 mmol/L, " Hi " will appear on the screen. Please repeat your test again with
another strip. If you still get a " Hi " result, you should immediately contact your doctor.
Limitations
- Grossly lipemic ( fatty ) samples may interfere with some methodologies. To be aware of such interferences,
patients under the supervision of their physician should have baseline glucose values established by a clinical
laboratory method prior to starting home glucose monitoring. These baseline values should be checked
periodically thereafter.
- Meter read capillary blood glucose values 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 2.8 mmol/L or above 13.9 mmol/L. Consult a
physician as soon as possible if values in this range are obtained.
Precautions
- Check the expiration date printed on the package every time you use the strip. 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.
- Wait at least 30 minutes to perform a test if you have moved the meter to an area of different temperature.
- If you want to purchase a new control solution, please contact your authorized Bionime representative.
21 3
5 6
4
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.
7 8
9
7) Wash your hands with warm soapy water and
dry thoroughly.
8) Take one strip from the vial. Re-cap the vial
cap immediately.
9) Insert the strip into the strip port on meter
with the indication symbol facing up.
11
10) While the blood drop symbol flashing, you are ready to apply the blood sample.
11) Place the lancing device against the pad of your fingertip and press the release button. The best puncture
sites are on the middle or ring fingers. Press the release button.
12
10
121614 15 17
13) You will see the countdown mode on the screen. After 8 seconds, the test result appears.
14) Pull off the depth adjustable cap. Without touching the used disposable lancet, stick the lancet tip into the
protective cover.
15) Hold the release button in one hand and pull on the plunger in the other hand will safely eject the used
disposable lancet.
16) Discard the used disposable lancet into an appropriate puncture-proof or biohazard container.
17) Replace the depth adjustable cap after finishing the test.
13
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.
1.0 1.4 2.0 3.0 .0 µL µL µL µL 4 µL
Sample Size Example
For more information on how to use your meter and understand your test results, see the
Instructions for use.
12) Touch and hold the drop to the edge of sample entry until you hear a " beep " 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.
Rightest™ GS100 BLOOD GLUCOSE TEST STRIP INSERT
(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
Please take a minimum of 1.4 μL to do the test on
glucose monitoring system. Blood sample size above
4.0 μL might contaminate the Smart Code Key.
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 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 )
clear cap
Pressing for
a few seconds
Preparing the Lancing Device
Releasing
button

Fingertip
61.0 % (94/154)
84.4 % (130/154)
100 % (154/154)
Palm
61.0 % (94/154)
85.1 % (131/154)
100 % (154/154)
Forearm
59.1 % (91/154)
87.7 % (135/154)
100 % (154/154)
Interferences
The following compounds may interfere with the glucose measurement at the concentrations listed:
Ascorbic Acid ≧ 5 mg/dL ( 0.28 mmol/L ) Dopamine HCl ≧ 2 mg/dL ( 0.11 mmol/L )
L-Dopa ≧ 3 mg/dL ( 0.15 mmol/L ) Tolazamide ≧ 15 mg/dL ( 0.48 mmol/L )
Cholesterol ≧ 500 mg/dL ( 12.93 mmol/L ) Glutathione reduced ≧ 60 mg/dL ( 1.95 mmol/L )
Hemoglobin ≧ 6,000 mg/dL ( 0.94 mmol/L ) Uric acid ≧ 9 mg/dL( 0.54 mmol/L )
Each Blood Glucose Test Strip contains the following reagents:
Glucose Oxidase (GOD) 8.5 %
Potassium Ferricyanide 48.5 %
Non-reactive Ingredients 43.0 %
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)〔Electronic Version〕
Retrieved Aug 21, 2015 from www.labtestsonline.org/understanding/analytes/glucose/test.html
2) In Vitro Diagnostics in Diabetes : Meeting the Challenge. Clinical Chemistry 45:9, 1596-1601 (1999).
101-3GS100-0J0 EN
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone] Fax: [phone]
E-mail: [email protected] http://www.bionime.com
Accuracy
The accuracy of the test study of the Blood Glucose Meter was demonstrated by comparing whole
blood (plasma equivalent) glucose values on the Rightest™ meter with plasma glucose values on a lab
instrument.
A total of 111 patients were enrolled. Each patient collected and tested their own blood samples ( from the
fingertip, palm and forearm) using the Rightest™ System.Then the blood samples were centrifuged immediately
after collection to obtain plasma. Analyze the plasma by the lab instrument - YSI 2300. 100 % of Rightest™
meter values were within ± 15 mg/dL (0.83 mmol/L) of the YSI values at glucose concentrations < 100 mg/dL
(5.55 mmol/L) and within ± 15 % at glucose concentrations ≧ 100 mg/dL (5.55 mmol/L).
The results and differences between the two methods, Rightest™ System and YSI 2300 (as the reference
method) are proved in the tables below.
Rightest™
Additional Information for Healthcare Professionals
(ii) Control solution:
P-01
300
47.1 (2.6)
1.5 (0.08)
3.2 %
P-02
300
104.3 (5.8)
2.9 (0.16)
2.8 %
P-03
300
133.0 (7.4)
2.7 (0.15)
2.1 %
(i) Venous whole blood sample:
Glucose levels
(1) Total test numbers (n)
(2) Mean mg/dL (mmol/L)
(3) SD mg/dL (mmol/L)
(4) CV (%)
Glucose levels
(1) Total test numbers (n)
(2) Mean mg/dL (mmol/L)
(3) SD mg/dL (mmol/L)
(4) CV (%)
- Doctors should evaluate their technique and their patients' technique at periodic intervals. To accomplish this, it
is recommended that meter 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.
- Fluoride should not be used as a preservation for venous specimens when using blood glucose monitors.
- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated results.
- Differences in whole blood and serum/plasma values may cause variability in results.
- Storage of strips near bleach as well as bleach containing products will affect results of glucose oxidase strips.
- The use of cellular phones and other radio transmitting devices should be prohibited in areas where testing
occurs.
- 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.
- Hematocrits should be between 35 % ~ 48 %. If you do not know your hematocrits, ask your healthcare
professional.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- Rightest™ Blood Glucose Monitoring System has not been validated for use on neonates.
Therefore, it should not be used for neonates.
- Do not perform the blood glucose test at temperatures below 10℃ (40 ℉) or above 50 ℃ (104 ℉ ) , below
10 % or above 90 % relative humidity.
(2)
Detection Principle
The glucose oxidase and potassium ferricyanide in the strip react with the glucose in the sample to produce an
electrical current which is proportional to the amount of glucose in the sample. The meter measures the current
and converts it to the corresponding glucose concentration.
Performance Characteristics
Precision
The precision was evaluated including (i) venous whole blood sample (ii) 3 levels glucose control solution in
period of 10 days, by 10 meters and 3 batches of strips.
Storage and Handling
- Store the strips in the original capped vial at temperatures between 4 to 30 (39 to 86 ), and relative
humidity between 10 % to 90 %.
- Replace the vial cap immediately and close tightly after taking test strip out from the vial. Do not leave the cap
of vial opened. If the strip is exposed in the air too long, it will absorb the moisture and cause wrong test result.
- Use test strips within 3 months after first opening.
℃ ℃ ℉ ℉
Troubleshooting and Customer Service
For more information on error messages and trouble shooting, please refer to the Error Messages and Trouble
Shooting section of the Rightest™ Instructions for use.
You may also contact customer service by calling local distributor or email to [email protected].
( At all other times, you could contact your healthcare professional for assistance )
Measurement Range
The measurement range of the Rightest™ System is 0.6 to 33.3 mmol/L.
Quality Control Section
Please refer to the Quality Control section of the Instructions for use.
P-04
300
227.5 (12.6)
3.8 (0.21)
1.7 %
P-05
300
349.2 (19.4)
5.1 (0.28)
1.5 %
CS-L
300
59.1 (3.3)
1.8 (0.10)
3.1 %
CS-N
300
109.9 (6.1)
2.4 (0.13)
2.2 %
CS-H
300
299.4 (16.6)
5.3 (0.29)
1.8 %
Bionime GmbH
Tramstrasse 16
9442 Berneck / Switzerland
E-mail: [email protected]
Difference range in values
between the value and
the Rightest™ meter value
YSI
Within ± 5 mg/dL (0.28 mmol/L)
Within ± 10 mg/dL (0.56 mmol/L)
Within ± 15 mg/dL (0.83 mmol/L)
Bias range in values
between the YSI value and
the Rightest™ meter value
Within ± 5 %
Within ± 10 %
Within ± 15 %
Table 2: represents samples for glucose concentrations ≧ 100 mg/dL (5.55 mmol/L).
Table 1: represents samples for glucose concentrations < 100 mg/dL (5.55 mmol/L).
* Acceptance criteria in ISO15197 : 2013 are that 95 % of all differences in glucose values should be within
± 15 mg/dL (0.83 mmol/L) at glucose concentrations < 100 mg/dL (5.55 mmol/L), and within ± 15 % at
glucose concentrations ≧ 100 mg/dL (5.55 mmol/L).
Note: For glucose concentrations < 100 mg/dL (5.55 mmol/L), difference values are expressed in mg/dL
(mmol/L), and for glucose concentrations ≧ 100 mg/dL (5.55 mmol/L), difference values are compared in
percentage.
The percent ( and number ) of samples of alternative site were
the difference between the Rightest™ and the YSI value
within the range shown in the side row.
The percent ( and number ) of samples of alternative site were the bias
between the Rightest™ and the YSI value within the range shown in the
side row.
Fingertip
58.8 % (40/68)
91.2 % (62/68)
100 % (68/68)
Palm
63.2 % (43/68)
92.6 % (63/68)
100 % (68/68)
Forearm
60.3 % (41/68)
88.2% (60/68)
100 % (68/68)
NOTE
- Suggest not to use this meter close to source of strong electromagnetic radiation, to avoid interference
with proper operation.
- Suggest to keep meter free of dust, water or any liquid.
CE Mark with number of Notified Body
LOT
Use by
Temperature limitations Lot number
IVD For in vitro diagnostic use For single use only
Reference number
Manufacturer
EU Representative
Consult instructions for use
Ve rsion: August 2017
Biological risks