OneTouch VitA User manual

Test Strips
Test Strips
follow their advice on treatment.1If you continue to get unexpected
results, check your system with control solution. If you are experiencing
symptoms that are not consistent with your blood glucose test results
AND you have followed all instructions described in your User’s
Handbook, call your health care professional. Never ignore symptoms or
make signicant changes to your diabetes control programme without
speaking to your health care professional.
Checking the System
Use only OneTouch® Vita™ Control Solutions
A control solution test is performed to check that the meter and test
strips are working together properly and that you are performing the
test correctly. For instructions on how and when to check the system
by performing a control solution test, refer to the User’s Handbook that
came with your system.
Limitations of the Procedure
OneTouch® Vita™ Test Strips give accurate results when the following
restrictions are observed:
• Do not use for the diagnosis of diabetes or for testing newborn
babies.
• Teststripsareforsingleuseonly.Do not re-use.
• TheteststripsarespecictoD-glucoseanddonotreactwithother
sugars that may be present in blood.
• Useonlyfreshcapillarywholeblood.Do not use serum or plasma.
• Haematocritisthepercentageofredbloodcellsintheblood.
Extremes in haematocrit may aect test results.2Haematocrit levels
below 30% may cause falsely high readings and haematocrit levels
over 55% may cause falsely low readings. If you do not know your
haematocrit level, consult your health care professional.
• OneTouch®Vita™TestStripsmaybeusedataltitudesupto3048
meters (10,000 feet) without an eect on test results. Accurate results
have been demonstrated in clinical studies performed at altitudes up
to1609meters(5,280feet)andinstudiessimulatingaltitudesupto
3048meters(10,000feet).
Health care professionals—please note these additional procedural
restrictions:
• Freshcapillarybloodmaybecollectedinheparin-containingtest
tubes if the blood is used within 10 minutes. Do not use other
anticoagulants or preservatives.
• Interferences:Paracetamol,salicylates,uricacid,ascorbicacid
(vitamin C), and other reducing substances (when occurring in normal
blood or normal therapeutic concentrations) do not signicantly
aect results. However, abnormally high concentrations in blood may
cause inaccurately high results.
• Patientsundergoingoxygentherapymayyieldfalselylowresults.
• Testresultsmaybefalselylowifthepatientisseverelydehydrated,in
shock, or in a hyperosmolar state (with or without ketosis). Critically ill
patients should not be tested with blood glucose meters.
• Hyperlipidaemicsamples:Cholesterollevelsupto18.1mmol/L
(700mg/dL)andtriglyceridesupto33.9mmol/L(3000mg/dL)do
not aect the results. Grossly hyperlipidaemic patient samples have
not been tested and are not recommended for testing with the
OneTouch® Vita™ Meter.
Test Principle
The OneTouch® Vita™ system is plasma-calibrated to allow easy
comparison of results with laboratory methods. Glucose in the
blood sample mixes with special chemicals on the test strip and a
small electrical current is produced. This current is measured by the
OneTouch® Vita™ 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 test strip contains: Glucose oxidase (Aspergillus niger) ≥0.08IU;
ferricyanide ≥22µg;otheringredients(buer,etc.).Theteststripvial
contains a drying agent.
Performance Characteristics
The performance of OneTouch® Vita™ Test Strips has been evaluated
both in laboratory and in clinical tests.2
Measurement Range: The measurement range of the OneTouch® Vita™
Systemis1.1–33.3mmol/L(20to600mg/dL).
System Accuracy: Diabetes experts have suggested that glucose meters
shouldagreewithin0.8mmol/L(15mg/dL)ofalaboratorymethod
whentheglucoseconcentrationislowerthan4.2mmol/L(75mg/dL),
IVD
For self-testing.
IMPORTANT: Please read this information and your OneTouch®
Vita™ User’s Handbook before using OneTouch® Vita™ Test Strips.
Do not use your OneTouch® Vita™ Test Strips if your vial is open
or damaged in any way as this could lead to error messages
or inaccurate blood glucose values. Call 0800 121 200 (UK) or
1800 535 676 (Ireland) immediately if the test strip vial is open or
damaged, or if these instructions or your meter results seem unclear.
Intended Use
OneTouch® Vita™ Test Strips are used with the OneTouch® Vita™ meter
for quantitatively measuring glucose in fresh capillary whole blood.
OneTouch® Vita™ Test Strips and meter are for use in ngertip, palm,
and forearm testing.
Storage and Handling
• Storetheteststripvialinacooldryplacebelow30°C(86°F).Do not
refrigerate. Keep away from direct sunlight and heat. Exposure to
temperaturesand/orhumidityoutsidetherequiredstorageconditions
may result in inaccurate readings.
• Storeyourteststripsintheiroriginal vial only. To avoid damage or
contamination, do not transfer test strips to any other container.
• Do not open the test strip vial until you are ready to test. Only open
vial when removing strips.
• Afterremovingateststripfromthevial,immediatelyclosetheviallid
tightly. Use each test strip immediately after removing it from the vial.
• Do not use test strips from any vial that is damaged or has been left
open to air.
• Writetheuse-bydate(dateopenedplus6months)ontheviallabel
when you rst open it.
• Do not use after the expiry date (printed on vial label) or use-by date,
whichever comes rst.
• Avoidgettingdirt,food,orliquidsontheteststrip.Withclean,dry
hands, you may touch the test strip anywhere on its surface.
• Do not bend, cut, or alter the test strip in any way.
• Teststripsareforsingleuseonly.Never re-use a test strip that has
had blood or control solution applied to it.
• Makesureyourmeterandteststripsareaboutthesametemperature
before you test.
• ApplyonlyOneTouch®Vita™ControlSolutionorabloodsampletothe
test strip.
• Afterperformingatest,do not return the used test strip to the vial.
WARNING: Keep the test strip vial away from children; test
strips are a choking hazard. Do not swallow test strips. The test
strip vial may contain drying agents that are harmful if inhaled or
swallowed and may cause skin or eye irritation. Do not ingest or
swallow any items.
Blood Glucose Test Procedure
For instructions on performing a blood test (including blood sample
collection) and the range of expected blood glucose values, refer to the
User’s Handbook that came with your system.
Test Results
TheOneTouch®Vita™Meterdisplaysresultsbetween1.1–33.3mmol/L
(20and600mg/dL).RefertotheUser’sHandbookfortherangeof
expected blood glucose values.
Low Glucose Values
Ifyourtestresultisbelow1.1mmol/L(20mg/dL),awarningmessage
will appear indicating a low glucose level. This may indicate severe
hypoglycaemia (low blood glucose). Treat this condition immediately,
according to your health care professional’s recommendations.
Although this message could be due to a test error, it is safer to treat rst
and then do another test.
High Glucose Values
Ifyourtestresultisabove33.3mmol/L(600mg/dL),awarningmessage
will appear indicating a high glucose level. This may indicate severe
hyperglycaemia (high blood glucose). You should re-test your glucose
level. If the message appears again, call your health care professional
immediately.
If You Get Unexpected Results
Ifyourbloodglucoseresultisbelow3.9mmol/L(70mg/dL),indicating
lowbloodglucose,orabove10.0mmol/L(180mg/dL),indicatinghigh
blood glucose, you should contact your health care professional and
AW 06528701A

©2008 LifeScan, Inc. Rev. date: 03/2008 AW 06528701A
LifeScan, Inc.
Milpitas, CA 95035 U.S.A.
LifeScan Regulatory Aairs Europe
Division of Ortho-Clinical Diagnostics France
1, rue Camille Desmoulins
92787 Issy-les-Moulineaux, Cedex 09
France
0344
Distributed By:
LifeScan UK/Ireland,
A div. of Ortho-Clinical Diagnostics,
Johnson & Johnson,
50 - 100 Holmers Farm Way,
High Wycombe, Bucks HP12 4DP
United Kingdom
www.LifeScan.co.uk
and within 20% of a laboratory method when the glucose concentration
is4.2mmol/L(75mg/dL)orhigher.Samplesfrom139patientsat2
clinical centres were tested using both the OneTouch® Vita™ System and
the YSI Model 2300 Glucose Analyzer laboratory instrument. The study
demonstrates that the accuracy of blood glucose results obtained by the
OneTouch® Vita™ System compares well with the laboratory method.2
For glucose results
lowerthan4.2mmol/L
(75mg/dL),thepercentage
(and number) of meter
results that match the
laboratory method are:
Within
0.3mmol/L
(5mg/dL)
Within
0.6mmol/L
(10mg/dL)
Within
0.8mmol/L
(15mg/dL)
(26/120)
21.7%
(78/120)
65.0%
(116/120)
96.7%
For glucose results at
4.2mmol/L(75mg/dL)or
higher, the percentage (and
number) of meter results
that match the laboratory
method are:
Within
5%
Within
10%
Within
15%
Within
20%
(268/714)
37. 5%
(500/714)
70.0%
(628/714)
88.0%
(704/714)
98.6%
Precision:
WithinRunPrecision Bloodav 2.4mmol/L(43mg/dL) CV=3.1%
Bloodav 6.1mmol/L(109mg/dL) CV=2.5%
Bloodav 7.6mmol/L(136mg/dL) CV=1.7%
Bloodav 11.8mmol/L(213mg/dL) CV=1.5%
Bloodav 19.5mmol/L(352mg/dL) CV=1.6%
TotalPrecision Control 2.1mmol/L(37mg/dL) CV=3.0%
Control 6.2mmol/L(111mg/dL) CV=2.3%
Control 19.5mmol/L(351mg/dL) CV=1.7%
This study shows a variability from test strip to test strip in blood tests
of ≤ 3.1%.
IMPORTANT: For complete operating instructions and other
important technical information, refer to the User’s Handbook
that came with your system. IF YOU HAVE QUESTIONS ABOUT THE
USE OF ANY LIFESCAN PRODUCT, PLEASE CALL 0800 121 200 (UK)
or 1800 535 676 (Ireland).
References
1. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York: Simon and
Schuster (1995), p. 158.
2. Data on file.
OUR COMMITMENT TO YOU: Our goal is to provide you with
quality health care products and dedicated customer service.
If you are not fully satised with this product, contact your
authorized LifeScan representative on 0800 121 200 (UK) or
1800 535 676 (Ireland).
Description of Symbols
For a complete description of all symbols used, refer to the User’s
Handbook that came with your system.