Rightest GS280 User manual

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1
Performing a Test
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 Solutions 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.
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 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.
- Flouoride 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.
- Storage of strips near bleach as well as bleach containing products will affect the results of the
RIGHTEST Test Strips.
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 and strips are exposed to a high temperature difference, please wait 30
minutes before measurement.
- If you want to purchase new control solutions, please contact your authorized Bionime representative.
1
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.
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.
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.
Please take a minimum of 0.75 μL to do the test on
glucose monitoring system. Blood sample size
above 3.0 μL 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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5
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.
Test Procedure
(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
23
6
0.75 1.0 3 μL μL 1.5μL 2.0 μL .0 μL
8
7
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
Intended Use
The RIGHTEST Blood Glucose Monitoring System is used by individuals with diabetes. It's for checking
on glucose levels of whole blood from capillary. Capillary blood can be sampled 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 GS280 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 the capillary blood and provides results equivalent to a laboratory
instrument (Plasma equivalent).
The RIGHTEST Blood Glucose Test Strip GS280 is designed for the following meters to obtain accurate
results: RIGHTEST Blood Glucose Meter GM280
RIGHTEST Blood Glucose Meter GM280B
BLOOD GLUCOSE TEST STRIP GS280 INSERT
TM
2
Palm
Forearm

Additional Information for Healthcare Professionals
Lay User Evaluation
A total of 100 users were enrolled. Each user tested their fingertip blood samples with strip GS280 and
meter GM280. Then the professional collected blood samples were centrifuged immediately after collection
to obtain plasma. Analyze the plasma by the lab instrument (YSI 2300 analyzer). 100% of the BGMS values
were within±15% of YSI values at glucose concentrations 100 mg/dl (5.55mmol/L) and within±15 mg/dL
(0.83 mmol/L) at glucose concentration <100 mg/dL (5.55 mmol/L).
Hematocrit
Hematocrit should be between 30%-57%. If you do not know your hematocrit, ask your healthcare
professional.
Lay User Evaluation
A total of 135 users were enrolled. Each user tested their fingertip blood samples with strip GS280 and
meter GM280B. Then the professional collected blood samples were centrifuged immediately after
collection to obtain plasma. Analyze the plasma by the lab instrument (YSI 2300 analyzer). 100% of the
BGMS values were within±15% of YSI values at glucose concentrations 100 mg/dl (5.55mmol/L) and
within±15 mg/dL (0.83 mmol/L) at glucose concentration <100 mg/dL (5.55 mmol/L).
Interferences
26 toxic amount tested substances: (acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine,
dopamine, EDTA, galactose, gentisic acid, glutathione, haemoglobin, heparin, ibuprofen, icodextrin,
L-DOPA, maltose, Methyl-DOPA, pralidoxime iodide, salicylate, tolbutamide, tolazamide,
triglycerides, uric acid, xylose, triglycerides, lactose)in two blood sample concentrations.
Substance and possible level may interfere the glucose measurement:
Ascorbic acid ≧ 6 mg/dL (0.34 mmol/L)
Uric Acid ≧ 16 mg/dL (0.95 mmol/L)
Glutathione reduced ≧ 70 mg/dL (2.28 mmol/L)
Reagents
Each Blood Glucose Test Strip contains the following reagents:
1.Potassium Ferricyanide 37.7 %
2.Glucose Oxidase (GOD) 18.8 %
3.Non-reactive Ingredients 43.5 %
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)〔Electronic Version〕
Retrieved Mar 02, 2018 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).
(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
As representative, Data of Precision were generated with RIGHTEST Blood Glucose Meter GM280B, data
of Accuracy and Lay User Evaluation were generated with RIGHTEST Blood Glucose Meter GM280.
Precision
The precision was evaluated including (i) venous whole blood sample-the blood sample are collected
over a span of time not to exceed one day per meter and reagent lot combination. (ii) 3 levels glucose
control solution in period of 10 days, by 10 meters and 3 batch of strip.
Storage and Handling
- Store the strips in the original capped vial at temperatures between 4°C to 30°C (39°F to 86°F) and
relative humidity below 90%. Do not freeze.
- 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 to the air too long, it will absorb the moisture and cause
wrong test result.
- When you open a new vial of test strips please write the opening date on the label. Use test strips
within 3 months after first opening or until the expiration date printed on the label (whichever comes
first).
Measurement Range
The measurement range of the RIGHTEST System is 10 to 600 mg/dL or 0.6 to 33.3 mmol/L.
Quality Control Section
Please refer to the Quality Control section of the User's Manual.
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 User's Manual.
If you have any questions or in case of problems with the RIGHTEST products, please contact your local
Bionime distributor or email to [email protected] .
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.
Difference range in values
between the YSI 2300
value and the RIGHTEST
meter value
Within± 5 mg/dL (0.28 mmol/L)
Within±10 mg/dL (0.56 mmol/L)
Within±15 mg/dL (0.83 mmol/L)
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.
Bias range in values
between the YSI 2300
value and the RIGHTEST
meter value
Within ± 5%
Within ± 10%
Within ± 15%
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.
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 ISO 15197 : 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 value are compared in
percentage.
(ii) Control solution:
P-01
300
43.6(2.4)
1.3 (0.07)
2.9 %
P-02
300
102.7(5.7)
2.2 (0.12)
2.1 %
P-03
300
134.5(7.5)
2.9(0.16)
2.2 %
(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 (%)
P-04
300
229.1(12.7)
4.2(0.23)
1.8 %
P-05
300
328.9(18.3)
4.9(0.27)
1.5 %
CS-L
300
44.8(2.5)
1.3(0.07)
2.9 %
CS-N
300
101.9(5.7)
2.2(0.12)
2.2 %
CS-H
300
274.5(15.2)
5.0(0.28)
1.8 %
Palm
253/426 (59.4 %)
405/426 (95.1 %)
425/426 (99.8 %)
Palm
128/198 (64.6 %)
192/198 (97.0 %)
198/198 (100 %)
Fingertip
133/198 (67.2 %)
193/198 (97.5 %)
198/198 (100 %)
Forearm
106/198 (53.5 %)
182/198 (91.9 %)
198/198 (100 %)
Fingertip
279/426 (65.5 %)
412/426 (96.7 %)
426/426 (100 %)
Forearm
247/426 (58.0 %)
413/426 (96.9 %)
425/426 (99.8 %)
Accuracy
The accuracy of the Blood Glucose Monitoring System GM280 was tested by comparing fingertip whole
blood (plasma equivalent) glucose values measured by the Blood Glucose Meter GM280 with plasma
glucose values obtained from a YSI 2300 reference instrument.
The YSI 2300 was calibrated with NIST (SRM) 917c reference.
The results and variations between the two methods, Blood Glucose Monitoring System GM280 and YSI
2300 (as the reference method) are shown in the tables below.
- 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.
- 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°C (50°F) or above 40°C (104°F), below
10% or above 90% relative humidity.
- The Control Solution Test should be conducted between 15 - 40 °C (59 - 104 °F).
Store between tempe rature 4°C and 30°C ( 39°F and 86 °F)
For in vitro diagnostic use Manufacturer
LOT
IVD
Lot number
For single use only EC Representive
Biological risks
CE-mark (with No. of notified body)
Consult the instruction for use
Expiry date
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
Bionime GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]
101-3GS280-020 EN
Rev. Date:2018-09