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Infection Control
Use universal blood precautions when handling, and disposing of, blood
glucose monitoring materials. All patient samples and materials with which
they come in contact are considered biohazards and should be handled as if
capable of transmitting infection. Follow proper precautions in accordance
with local regulations when disposing of all materials.
CAUTION: To reduce the chance of infection:
Never share a lancet or the lancing device with anyone. Always use a
new, sterile lancet. Lancets are for single use only. Keep your meter and
lancing device clean. Make sure to wash the puncture site with soap and
water before testing.
Test Principle
The OneTouch SelectSimple® System is plasma-calibrated to allow easy
comparison of results with laboratory methods. Glucose in the blood sample
mixes with special chemicals in the test strip and a small electrical current
is produced. This current is measured by the OneTouch SelectSimple® Meter
and displayed as your blood glucose result. The strength of this current
changes with the amount of glucose in the blood sample.
Reagent Composition
Each OneTouch Select® Test Strip contains: Glucose oxidase (Aspergillus
niger) ≥0.08 IU; ferricyanide ≥22 µg; other ingredients (buffer, etc.). The vial
contains a drying agent.
Performance Characteristics
The performance of OneTouch Select® Test Strips has been evaluated both in
laboratory and in clinical tests.
3
Measurement range: The measurement range of the OneTouch Select®
System is 20 to 600 mg/dL (1.1–33.3 mmol/L).
Clinical accuracy: The accuracy of the OneTouch Select® System was
assessed by comparing blood glucose results obtained by patients with
those obtained using a YSI Model 2300 Glucose Analyser, a laboratory
instrument. The following results were obtained by 163 diabetic patients at
3 clinical centres:
Slope
y-intercept
Correlation coefficient (r)
No. of samples
Range tested
This study shows that the OneTouch Select® Meter compares well with a
laboratory method.
3
Precision:
Within Run Precision
Blood av 42 mg/dL (2.3 mmol/L)
Blood av 106 mg/dL (5.9 mmol/L)
Blood av 139 mg/dL (7.7 mmol/L)
Blood av 224 mg/dL (12.4 mmol/L)
Blood av 355 mg/dL (19.7 mmol/L)
Total Precision
Control 36 mg/dL (2.0 mmol/L)
Control 110 mg/dL (6.1 mmol/L)
Control 337 mg/dL (18.7 mmol/L)
This study shows a variability from test strip to test strip in blood tests of
3.0% or less.
This data was generated using the OneTouch Select® Meter. OneTouch
Select® system performance is representative of the OneTouch Select®
Family of Meters (OneTouch Select® and OneTouch SelectSimple®).
Please refer to your Owner's Guide for performance information for your
OneTouch SelectSimple® Meter.
For a complete description of operating instructions
IMPORTANT:
and other important technical information, please refer to
the Owner's Guide that came with your system. IF YOU HAVE
QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCT, PLEASE
CONTACT CUSTOMER SERVICE AT 1800 225544.
References
1. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York: Simon
and Schuster (1995), p. 158.
2. American Diabetes Association, Position Statement, Diagnosis and
Classification of Diabetes Mellitus, Diabetes Care 31:S55-S60, 2008.
3. Data on file.
OUR COMMITMENT TO YOU:
Creating a world without limits for people with diabetes is what
OneTouch® is all about. To enjoy the benefits that OneTouch® has to
offer, kindly call the customer service at 1800 225544 to enroll on to
our OneTouch® Zone programme.
Description of Symbols
For a complete description of all symbols used, refer to the Owner's Booklet
or User Guide that came with your system.
Consult instructions for use
2
Do not re-use
Expiry Date
In Vitro Diagnostic Medical Device
Lot Number
Storage temperature limits
Contains sufficient for <n> tests
Date of Manufacture
0.979
-3.4 mg/dL (-0.2 mmol/L)
0.985
163
43–486 mg/dL (2.4–27.0 mmol/L)
CV = 3.0%
CV = 1.8%
CV = 1.5%
CV = 1.5%
CV = 1.6%
CV = 3.2%
CV = 2.1%
CV = 2.3%
Manufactured For:
LifeScan Inc.
20 Valley Stream Parkway,
Malvern, PA 19355, USA
AW 06695904A
Patent https://www.onetouch.com/patents
© 2018-2023 LifeScan
IP Holdings, LLC
Test Strips Made in UK
Rev. date: 08/2023
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