Rightest Wiz User manual

Wiz BLOOD GLUCOSE TEST STRIP INSERT
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 Wiz 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 to 600 mg/dL or 0.6 to 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 contact your healthcare professional
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.
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 or Test Strips are exposed to temperature environments out of operating
range– below 10°C (50°F) or above 40°C (104°F)– please wait 30 minutes before testing again.
- If you want to purchase new control solutions, please contact your authorized Bionime representative.
8) 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.
For more information on how to use your meter, lancing device and understand your test results,
see the User’s Manual.
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
7
(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
0.75 1.0 3μL μL 1.5 μL 2.0 μL .0 μLPlease 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
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
RIGHTEST Wiz and Wiz Plus Blood Glucose Monitoring Systems are 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 Wiz 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.
RIGHTEST System tests the capillary whole blood and provides results equivalent to plasma result in
laboratory test.
RIGHTEST Wiz Blood Glucose Test Strip is designed for use with RIGHTEST Wiz / Wiz Plus Blood
Glucose Meter to obtain accurate results.
Performing a Test 1
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.
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.
2
4
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 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
3 5
7654
32
1
Palm
Forearm

101-3GS570-030 EN
Troubleshooting and Customer Service
For more information on error messages and trouble shooting, please refer to the Error Messages and
Trouble Shooting section of RIGHTEST User's Manual.
If you have any questions or in case of problems with RIGHTEST products, please contact local Bionime
distributor or email to [email protected] .
Lay User Evaluation
A total of 110 layperson were enrolled. Each patient tested their fingertip blood samples with 3 lots of Wiz
blood glucose test strip and Wiz Plus meter. 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 RIGHTEST Wiz Plus BGMS were within ± 15% of YSI values at glucose
concentrations ≧ 100 mg/dL (5.55 mmol/L) and within ± 15 mg/dL (0.83 mmol/L) at glucose
concentrations < 100 mg/dL (5.55 mmol/L).
Hematocrit
Hematocrit should be between 20 to 60%. If you do not know your hematocrit, ask your healthcare
professional.
Interferences
26 toxic amount tested substances (Acetaminophen, Ascorbic acid, Dopamine, EDTA, Gentisic acid,
Heparin, Ibuprofen, L-dopa, Methyldopa, Pralidoxime iodide, Salicylic Acid, Tetracycline, Tolazamide,
Tolbutamide, Bilirubin, Cholesterol, Creatinine, Glutathione, Haemoglobin, Triglycerides, Uric acid, Maltose,
Xylose, Galactose, Lactose, Icodextrin) in two blood sample concentrations.
Substance and possible level may interfere the glucose measurement:
Ascorbic acid ≧ 6 mg/dL (0.34 mmol/L)
Glutathione reduced ≧ 70 mg/dL (2.28 mmol/L)
Uric Acid ≧ 16 mg/dL (0.95 mmol/L)
Reagents
Each Blood Glucose Test Strip contains the following reagents:
Glucose Oxidase (GOD) 18.8 %
Potassium Ferricyanide 37.7 %
Non-reactive Ingredients 43.5 %
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)〔Electronic Version〕
Retrieved May. 08, 2019 from www.labtestsonline.org/understanding/analytes/glucose/test.html
2) Review of Glucose Oxidases and Glucose Dehydrogenases: A Bird's Eye View of Glucose Sensing
Enzymes. J Diabetes Sci Technol 2011 Sep; 5(5): 1068–1076 (2011).
Accuracy
The accuracy of Blood Glucose Monitoring System was tested by comparing RIGHTEST Wiz Plus
fingertip whole blood (plasma equivalent) glucose values measured by Blood RIGHTEST Wiz Plus
Glucose Meter 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 RIGHTEST Wiz Plus
System and YSI 2300 (as the reference method) are shown in the tables below.
Additional Information for Healthcare Professionals
(ii) Control solution:
P-01
300
38.6 (2.1)
1.1 (0.06)
2.8 %
P-02
300
84.7 (4.7)
1.7 (0.09)
2.0 %
P-03
300
136.5 (7.6)
2.5 (0.14)
1.8 %
(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 (%)
(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
Data generated using RIGHTEST Wiz Plus Blood Glucose Meter. RIGHTEST Wiz Plus Blood Glucose
Meter is the representative of the RIGHTEST Wiz Blood Glucose Meter family (included Wiz and Wiz
Plus Blood Glucose Meter).
Precision
The precision was evaluated including (i) 5 glucose levels of venous whole blood samples (blood
samples were collected with heparin tube and altered for test after 8 hours) (ii) 3 glucose levels of
control solution, in period of 10 days, by 10 meters and 3 batches of strips.
P-04
300
221.2 (12.3)
2.9 (0.16)
1.3 %
P-05
300
329.9 (18.3)
4.4 (0.24)
1.3 %
CS-L
300
37.9 (2.1)
1.0 (0.06)
2.6 %
CS-N
300
85.4 (4.7)
1.5 (0.08)
1.8 %
CS-H
300
246.4 (13.7)
2.6 (0.14)
1.0 %
Quality Control Section
Please refer to the Quality Control section of the User's Manual.
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.
- Close the vial cap immediately and 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 first opening date on the label. Use test strips
within 12 months after first opened or until the expiration date printed on the label (whichever comes first).
Measurement Range
The measurement range of RIGHTEST System is 10 to 600 mg/dL or 0.6 to 33.3 mmol/L.
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.
- 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.
- 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.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- Patients going through oxygen therapy may yield falsely 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 suggested temperature range for the control solution test is
15 to 40°C (59 to 104°F).
Difference range in values
between the YSI value and
RIGHTEST Wiz Plus meter
The percent ( and number ) of samples was the difference between RIGHTEST
Wiz Plus blood glucose meter and the YSI value within the following intervals.
Difference range in values
between the YSI value and
RIGHTEST Wiz Plus meter
Within ± 5 %
Within ± 10 %
Within ± 15 %
The percent ( and number ) of samples was the difference between RIGHTEST
Wiz Plus blood glucose meter and the YSI value within the following intervals.
*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.
Fingertip
65.0% (277/426)
98.4% (419/426)
100%(426/426)
Palm
62.4%(266/426)
95.5%(407/426)
100%(426/426)
Forearm
59.6%(254/426)
95.1%(405/426)
100%(426/426)
Fingertip
68.2%(135/198)
97.5%(193/198)
100% (198/198)
Palm
68.2%(135/198)
98.5%(195/198)
100% (198/198)
Forearm
53.5%(106/198)
92.4%(183/198)
100% (198/198)
Within ± 5 mg/dL (0.28 mmol/L)
Within ± 10 mg/dL (0.56 mmol/L)
Within ± 15 mg/dL (0.83 mmol/L)
Table 2: Represents samples for glucose results ≧ 100 mg/dL (5.55 mmol/L).
Table 1: Represents samples for glucose results < 100 mg/dL (5.55 mmol/L).
Rev. Date:2019-05
For in vitro diagnostic use Manufacturer
IVD For single use only EC Representive
LOT
Lot number
CE-mark (with No. of notified body)
Consult the instruction for use
Store between tempe rature 4°C and 30°C ( 39°F and 86 °F) Biological risks Expiry date
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