Lifescan Blue OneTouch Ultra User Manual

In vitro diagnostic. For self-testing.
IMPORTANT: Please read this information and your OneTouch
the OneTouch Ping System User Guide before using blue OneTouch
® ™
Do Not use your blue OneTouch ® Ultra
any way as this could lead to error messages or inaccurate blood glucose values. Call the
OneTouch Customer Care Line at 1 800 663-5521 immediately if the test strip vial is open
®
or damaged, or if these instructional materials or your meter results seem unclear. If you
cannot reach Customer Service, contact your healthcare professional for advice.
Intended Use
Blue OneTouch Ultra Test Strips are used with the OneTouch
® ®
OneTouch ® Ping ™ System for quantitatively measuring glucose in fresh capillary whole blood.
The blue OneTouch Ultra Test Strips and associated meters are intended for use by people
® ®
with diabetes at home and healthcare professionals in the clinical setting. Blue OneTouch
Ultra Test Strips and associated meters are for use in fingertip, forearm, and palm testing.
®
Storage and Handling
• Store the test strip vial in a cool dry place below 30°C. 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
test 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 left open to air.
• Write the discard date (date opened plus 6 months) on the vial label when you first open it.
• Do Not use test strips beyond the expiration (printed on vial label) or discard date,
whichever comes first.
• 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 reuse a test strip that 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 control solution or a blood sample to the test strip.
• After performing a test, Do Not return the used test strip to the vial.
• Used test strips may be considered biohazardous waste in your area. Be sure to follow your
healthcare professional's recommendations or your local regulations for proper disposal.
WARNING: Keep the test strip vial away from children; test strips are a choking
m
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), refer to
the User Guide that came with your system.
IMPORTANT: Some meters in the OneTouch
Ping ™ System require coding. For meters that require coding, matching the code
on the meter to the code on the test strip vial is essential to obtain accurate
results. Refer to the User Guide that came with your system to determine if your
meter requires coding and get detailed instructions on coding.
Test Results
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 hypoglycemia (low blood glucose). Treat this
condition immediately, according to your healthcare professional's recommendations.
Although this message could be due to a test error, it is safer to treat first, 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 hyperglycemia (high blood glucose).
You should retest your glucose level. If the message appears again, call your healthcare
professional immediately.
If You Get Unexpected Results
If your blood glucose result is below 4.0 mmol/L (72 mg/dL)
or above 10.0 mmol/L (180 mg/dL), indicating high blood glucose, you should contact and
follow your healthcare professional's treatment advice.
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 Guide, call your healthcare professional. Never ignore symptoms
or make significant changes to your diabetes control program without speaking to your
healthcare professional.
Range of Expected Values
Blood glucose management requires the help of a healthcare professional. Together you can
set your own range of expected blood glucose values, arrange your testing times, and discuss
the meaning of your blood glucose results.
Expected blood glucose levels for people without diabetes:
Time Range, mmol/L
Fasting Less than 6.1
2 hours after meals Less than 7.8
Checking the System
Use OneTouch ® Ultra ® Control Solution
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 Guide that came with
your system.
Limitations of Procedure
Blue OneTouch Ultra Test Strips give accurate results when the following limitations
® ®
are observed:
• Do Not use for the diagnosis of diabetes or for testing of newborns.
• Test strips are for single use only. Do Not reuse.
• The test strips are specific to D-glucose and do not react to other sugars, which may be
present in blood.
• Use only fresh capillary whole blood. Do Not use serum or plasma.
• Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit
may affect test results. Hematocrit levels below 30% may cause falsely high readings
3
and hematocrit levels over 55% may cause falsely low readings. If you do not know your
hematocrit level, consult your healthcare professional.
• Blue OneTouch Ultra Test Strips may be used at altitudes up to 3048 meters
® ®
(10,000 feet) without an effect on test results. Accurate results were 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).
Healthcare professionals—please note these additional limitations of procedure:
• Fresh capillary blood may be collected into heparin-containing test tubes if the blood is
used within 10 minutes. Do Not use other anticoagulants or preservatives.
• Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C), and
other reducing substances (when occurring in normal blood or normal therapeutic
concentrations) do not significantly affect 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 by
blood glucose meters.
• Lipemic 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 affect the results. Grossly lipemic patient samples have
not been tested and are not recommended for testing with the OneTouch
Meters and the OneTouch Ping ™ System.
®
Test Principle
The OneTouch ® Ultra ® Family of Meters and OneTouch
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 Ultra Family of Meters and OneTouch
® ®
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 (buffer, etc.). The test strip vial contains a drying agent.
® Ultra ® Family of Meters and
Ultra Test Strips.
® ®
® Brand Test Strips if your vial is open or damaged in
Ultra Family of Meters and
® ®
Ultra Family and the OneTouch
® ®
2 , indicating low blood glucose,
1 If you continue to get unexpected
2
Range, mg/dL
Less than 110
Less than 140
Ultra
®
® Ping ™ System are plasma-calibrated to
Ping System and
® ™
Performance Characteristics
The performance of blue OneTouch
and in clinical tests.
Measurement Range: The measurement range of the OneTouch
1.1 to 33.3 mmol/L (20– 600 mg/dL).
System Accuracy: Diabetes experts have suggested that glucose meters should agree within
0.83 mmol/L (15 mg/dL) of a laboratory method when the glucose concentration is lower
than 4.2 mmol/L (75 mg/dL), and within 20% of a laboratory method when the glucose
concentration is 4.2 mmol/L (75 mg/dL) or higher. Samples from 100 diabetic patients at 1
clinical center were tested using both the OneTouch
Glucose Analyzer (laboratory test).
System Accuracy Results for Glucose Concentrations <4.2 mmol/L (75 mg/dL)
®
Percent (and number) of meter results that
match the laboratory test
System Accuracy Results for Glucose Concentrations ≥4.2 mmol/L (75 mg/dL)
Percent (and number) of meter results that
match the laboratory test
System Accuracy Results across the entire Glucose Range
Percent (and number) of meter results that
match the laboratory test
Therefore, 96.3% of the total results obtained with the OneTouch
the goal suggested by the diabetes experts.
Regression Statistics: Samples were tested in duplicate on each of 3 test strip lots. Results
indicate that the OneTouch
Number Number
of of Tests
Subjects
100 600
Precision:
Within Run Precision
(100 venous blood tests per glucose level)
Target Mean
Glucose Glucose
mmol/L mmol/L
(mg/dL) (mg/dL)
2.2 2.28
(40) (41.0)
®
5.6 5.40
(100) (97.4)
7.2 6.70
(130) (120.7)
11.1 11.15
(200) (200.9)
16.7 16.96
(300) (305.6)
Results show that the greatest variability observed between test strips when tested
with blood is 2.5% or less.
Data generated using OneTouch
of the OneTouch
®
OneTouch ® UltraMini
IMPORTANT: For complete operating instructions and other important technical
information, refer to the User Guide that came with your system. IF YOU HAVE
QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT the
OneTouch ® Customer Care Line at 1 800 663-5521. If you cannot reach Customer
Service, contact your healthcare professional for advice.
References
1. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York: Simon and Schuster
(1995), p. 158.
2. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian
Diabetes Association 2008 Clinical Practice Guidelines for the Prevention and Management
of Diabetes in Canada. CJ Diabetes 2008:32 (suppl 1) S11, S62.
3. Data on file.
OUR COMMITMENT TO YOU:
Our goal is to provide you with quality healthcare products and dedicated customer
service. If you are not fully satisfied with this product, we offer a No-Risk, Money-
Back Guarantee and will refund your purchase within 30 days. Please contact us
regarding a refund or with questions about the use of any OneTouch
assistance, please contact the OneTouch
If you cannot reach Customer Service, contact your healthcare professsional
for advice.
Covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862,
6,284,125, and 7,112,265. Use of these test strips and associated monitoring device is
protected under the following U.S. patents: 6,413,410, 6,733,655, 7,250,105. Purchase
of the associated monitoring device does not act to grant a use license under these
patents. Such a license is granted only when the associated monitoring device is used with
OneTouch ® Ultra ® Test Strips. No test strip supplier other than LifeScan, Inc. is authorized to
grant such a license. The accuracy of results generated with LifeScan meters using test strips
manufactured by anyone other than LifeScan has not been evaluated by LifeScan.
Family of
®
® Ultra ® Test Strips has been evaluated both in laboratory
3
Ultra
®
3
Within
± 0.28 mmol/L
(5 mg/dl)
48.8% (41/84)
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
38.0% 68.0%
(196/516) (351/516)
Within ± 0.83 mmol/L
(15 mg/dL) or ± 20%
96.3% (578/600)
Ultra 2 System compares well with a laboratory method.
® ®
Slope Intercept 95% CI Slope 95% CI Intercept
mmol/L mmol/L (mg/dL)
(mg/dL)
-0.012 -0.168 to 0.145
0.972 0.958 to 0.985
(-2.657) (-5.415 to 0.102)
Total Precision (200 control solution tests
per glucose level)
Standard Coefficient Glucose
deviation of Levels
mmol/L variation
(mg/dL) (%)
0.057
2.50 LOW
(1.02)
0.096
1.78 MID
(1.74)
0.116
1.74 HIGH
(2.10)
0.160
1.43
(2.87)
0.197
1.16
(3.55)
® Ultra ® 2 Meter. OneTouch
Ultra Family of Meters (OneTouch
® ®
® , OneTouch ® UltraSmart ® ) and the OneTouch
Customer Care Line at 1 800 663-5521.
®
® Ultra ® Family of Meters is
2 System and the YSI Model 2300
®
Within Within
± 0.56 mmol/L ± 0.83 mmol/L
(10 mg/dl) (15 mg/dl)
84.5% (71/84) 100.0% (84/84)
88.2% 95.7%
(455/516) (494/516)
® Ultra ® 2 System achieved
Std. Error R
2
(Sy.x)
mmol/L
(mg/dL)
1.000
0.973
(17.743)
Mean Standard Coefficient
Glucose deviation of
mmol/L mmol/L variation
(mg/dL) (mg/dL) (%)
2.59 0.056
2.18
(46.6) (1.01)
6.39 0.121
1.90
(115.1) (2.19)
19.47 0.304
1.56
(350.8) (5.48)
® Ultra ® 2 is representative
Ultra , OneTouch Ultra 2,
® ® ®
® Ping ™ System.
® products. For