ONE TOUCH Ultra Test strips

AW 06018108B

Test Strips

For Testing Glucose in Whole Blood

IMPORTANT: Please read this information and your
O

NE TOUCH

Booklet before using O

®

Ultra Brand or InDuo™Brand Owner’s

NE TOUCH

®

Ultra Test Strips.

Intended Use

ONE TOUCH Ultra Test Strips are used with ONE TOUCH

®

Ultra Brand and InDuo™Brand Blood Glucose Meters
for quantitatively measuring glucose in whole blood.

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read the glucose level of a whole blood sample on a

NE

O
InDuo

®

TOUCH

TOUCH

Ultra Brand and InDuo™Brand Meters

Ultra Test Strip. O

™

Brand Systems are plasma-calibrated to allow

NE TOUCH

®

Ultra Brand and

easy comparison of results with laboratory methods.

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Ultra Test Strips are for testing outside the

body (in vitro diagnostic use).

Storage and Handling

Original Vial

• Store the test strip package in a cool, dry
place not above 86°F (30°C). Keep away
from direct sunlight and heat. Do not
refrigerate.

• Store your test strips in their original vial
only; do not transfer them to a new vial
or any other container.

• After removing a O
Strip from the vial, immediately
replace the vial cap and close it tightly.

NE TOUCH Ultra Test

(Example)

• Use each test strip immediately after
removing it from the vial.

• Write the discard date on the vial label when you first
open it. Discard remaining O

NE TOUCH Ultra Test Strips

3 months after first opening the vial.

• Avoid getting dirt or food on the top edge.

• Do not use test strips beyond the expiration date print­ed on the package since they may cause inaccurate
results.

• Do not bend, cut, or alter a O

NE

Ultra Test Strip

TOUCH

in any way.

WARNING: Keep the test strip vial away from
children; the cap is a choking hazard. Also, the
cap may contain drying agents that are harmful if
inhaled or swallowed and may cause skin or eye
irritation.

Precautions to Obtain Accurate Results

• Code the O

NE TOUCH Ultra

Brand or InDuo Brand
Blood Glucose Meter to
match the code number

TOUCH

printed on the O

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Ultra Test Strip vial.

• Use only O

NE TOUCH Ultra

Test Strips with the

NE TOUCH Ultra Brand

O
or InDuo Brand Meter

(Example)

to obtain accurate and
consistent results.

• If you are experiencing symptoms that are not consis-

tent with your blood glucose test results AND you have
followed all instructions described in your O

NE TOUCH

Ultra Brand or InDuo Brand Owner’s Booklet, call your
healthcare professional.

• Never make significant changes to your diabetes control

program or ignore physical symptoms without speaking
with your healthcare professional.

Test Procedure for Blood Glucose Measurement

Materials provided: O
Materials required but not provided: O

Brand or InDuo Brand Blood Glucose Meter with Owner’s
Booklet; O

NE TOUCH

NE TOUCH Ultra Test Strips.

NE TOUCH Ultra

®

UltraSoft Adjustable Blood Sampler;

new, sterile lancet.

Blood Sample Collection

NE TOUCH Ultra Test Strips are designed to be used with

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fresh whole blood. You may obtain a blood drop from
either a fingertip or an arm. If you choose to puncture the
arm, select a soft, fleshy area (away from bone) that is free
of visible veins or excess hair. To obtain a drop of blood,
follow these steps:

Step 1: Wash your hands and the puncture site. Use warm,
soapy water. Rinse and dry thoroughly.

Step 2: Select and lance a puncture site. Use the

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TOUCH

®

UltraSoft Sampler to obtain a drop of

blood. If puncturing the arm, you may choose to set the

NE TOUCH UltraSoft Sampler for a greater puncture

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depth. Do not squeeze excessively on the puncture site.
If you use an alcohol swab, make sure that the site is
completely dry before lancing it.

Important Information About Arm Testing

• Consult your healthcare professional before you begin
using the arm for testing.

• Under certain conditions, blood glucose test results
obtained using samples taken from your arm may
differ significantly from fingertip samples.

• The conditions in which these differences are more
likely to occur are when your blood glucose is chang­ing rapidly such as following a meal, an insulin dose,
or associated with physical exercise.

• When blood glucose is changing rapidly, fingertip
samples show these changes more quickly than
arm samples.

• When your blood glucose is falling, testing with a fin­gertip sample may identify a hypoglycemic (low blood
sugar) level sooner than a test with an arm sample.

• Use arm samples only for testing prior to, or more than
two hours after, meals, insulin dose, or physical exer­cise.

• Testing performed within two hours after meals, an
insulin dose, or physical exercise, or whenever you
feel that your glucose levels may be changing rapidly,
should be done from the fingertip.

• You should also use fingertip testing whenever you
have a concern about hypoglycemia (insulin reactions)
such as when driving a car, particularly if you suffer
from hypoglycemic unawareness (lack of symptoms to
indicate an insulin reaction), as arm testing may fail to
detect hypoglycemia.

• Use arm or fingertip samples for testing prior to, or
more than two hours after, meals, insulin dose, or
physical exercise. Routine testing before meals can be
done either at the fingertip or the arm.

Blood Glucose Testing

Step 1: Insert test strip. Remove
a test strip from the vial. Recap
the vial immediately. With the
contact bars end first and facing
up, insert the test strip into the
test port. Push it in firmly until
it will go no further. The meter

Top Edge

Apply a
drop of
blood
here.

Confirmation

Window

Confirms
enough
blood
applied
to top
edge.

will turn on automatically. All
segments will appear briefly on
the display. Then “code 12”
(example) will appear. Make sure
the code number on the display
matches the code number on the
test strip vial. If the code num­bers do not match, code the
meter correctly. After the code
number, the symbol will

Contact Bars

appear.

Step 2: Apply sample. Obtain a round drop of blood. The
blood sample must be at least 1 microliter in volume

( actual size) or you may get an inaccurate test result.
While the symbol is displayed, touch and hold a drop

of blood to the TOP EDGE of the test strip, where it
meets the narrow channel. Do not push your finger

against the test strip or try to apply a smeared sample.
Hold the blood drop to the TOP EDGE of the test strip
until blood has completely filled the confirmation win­dow before the meter begins to count down. If the confir­mation window does not fill completely before the meter
begins to count down, do not add blood to the test strip;
discard the test strip and retest. If you have trouble filling
the test strip, contact LifeScan Customer Services for
assistance.
Step 3: Accurate results in just 5 seconds. Your blood
glucose result will appear on the display in just 5 sec­onds. Blood glucose results are automatically stored in
the meter memory. Turn the meter off by removing the
test strip.

For detailed information on the test procedure and cod­ing your meter, please refer to your O

NE TOUCH Ultra

Brand or InDuo Brand Owner’s Booklet.

Test Results

• Blood glucose test results are shown on the meter as

either milligrams of glucose per deciliter of blood
(mg/dL) or millimoles of glucose per liter of blood
(mmol/L), depending on which unit of measurement
you have selected.

NE TOUCH Ultra Brand and InDuo Brand Meters

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display results between 20 and 600 mg/dL
(1.1–33.3 mmol/L). If your test result is lower than
20 mg/dL (1.1 mmol/L), “lo” will appear on the
meter display. This indicates severe hypoglycemia (low
blood glucose).

You should immediately treat hypoglycemia as recom­mended by your healthcare professional. If your test
result is above 600 mg/dL (33.3 mmol/L), “

hhii

” will
appear on the meter display. This indicates severe
hyperglycemia (high blood glucose). You should seek
immediate medical assistance.

• When your blood glucose result is above 240 mg/dL

(13.3 mmol/L) or reads “hi,” “ketones?” will appear on
the meter display. This message does not mean that the
system detected ketones but that testing with a ketone
strip may be advisable.

Range of Expected Values

Blood glucose monitoring 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, mg/dL Range, mmol/L

Before breakfast 70–105 3.9–5.8
Before lunch or dinner 70–110 3.9–6.1
1 hour after meals Less than 160 Less than 8.9
2 hours after meals Less than 120 Less than 6.7
Between 2 and 4

1

AM Greater than 70 Greater than 3.9

If You Get Unexpected Results:

IMPORTANT: Low or high blood glucose readings can
indicate a potentially serious medical condition. If
your blood glucose reading is unusually low or high,
or you do not feel the way your reading indicates,
repeat the test with a new test strip. If your reading is
not consistent with your symptoms or if your blood
glucose result is less than 60 mg/dL (3.3 mmol/L) or
higher than 240 mg/dL (13.3 mmol/L), you should
contact your healthcare professional and follow his
or her treatment advice.

Quality Control: Checking the System

Do a Control Solution Test:

• When you begin using a new vial of test strips

• At least once a week

• Whenever you suspect that the meter or test strips are
not working properly

• When your blood glucose test results are not consistent
with how you feel, or when you think your results are
not accurate

• If you drop the meter

When control solution is applied to the top edge of the

NE TOUCH

O

®

Ultra Test Strip, you should get results with­in the expected range printed on the test strip vial. If
control solution test results fall outside this range, repeat
the test. Results that fall outside the range may be caused
by:

• Error in performing the test

• Failure to shake the control solution vial well enough

(must shake vigorously)

• Expired or contaminated control solution

• Improper coding of the meter

• Test strip deterioration

• Meter malfunction

• Control solution that is too warm or too cool

• Failure to discard the first drop of control solution

IMPORTANT: If you continue to get ONE TOUCH®Ultra
Control Solution test results that fall outside the range
printed on the vial, the O

™

InDuo

Brand System may not be functioning properly.

NE TOUCH

®

Ultra Brand or

DO NOT use the system to test your blood until you get
a control solution test result that falls within the
range. If you continue to have problems, call LifeScan
Customer Services at 1 800 227-8862.

• 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
lower 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 600 mg/dL
and triglycerides up to 400 mg/dL do not affect the
results. Grossly lipemic patient samples have not been
tested and are not recommended for testing with

OUCH

O

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Ultra Brand and InDuo Brand Systems.

Test Principle

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 O

NE

TOUCH

®

Ultra Brand or InDuo™Brand Meter and displayed as
your blood glucose result. The strength of these currents
changes with the amount of glucose in the blood sample.

Reagent Composition

NE TOUCH Ultra Test Strip contains: Glucose oxi-

Each O
dase (Aspergillus niger) ≥0.8 IU; other ingredients (media­tor, buffer, etc.) ≥0.05 mg. The vial or vial cap contains
approximately 1.4 g silica gel or 2.8 g of molecular sieve.

Performance Characteristics

The performance of O

NE TOUCH

evaluated both in laboratory and in clinical tests.

Ultra Test Strips has been

2

Measurement range: The measurement range of the

NE TOUCH Ultra System is 20 to 600 mg/dL

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(1.1–33.3 mmol/L).

Accuracy: The accuracy of the O

NE TOUCH Ultra System

was assessed by comparing blood glucose results
obtained by patients with those obtained using a YSI
Model 2300 Glucose Analyzer, a laboratory instrument.
The following results were obtained by 117 diabetic
patients at 3 clinical centers:

Slope 0.986
y-intercept -5.5 mg/dL
Correlation coefficient (r) 0.984
No. of samples 117
Range tested 36.4–434 mg/dL

This study shows that the O

NE TOUCH Ultra System com-

pares well with a laboratory method.

Precision:

Within Run Precision Bloodav45 mg/dL CV = 3.2%

Total Precision Control 44 mg/dL CV = 4.4%

Bloodav77 mg/dL CV = 2.0%
Bloodav129 mg/dL CV = 2.1%
Bloodav220 mg/dL CV = 1.8%
Bloodav364 mg/dL CV = 1.6%

Control 171 mg/dL CV = 2.6%
Control 366 mg/dL CV = 2.4%

This study shows a variability from strip to strip in blood
tests of 3.2% or less.

IMPORTANT: For a complete description of oper­ating instructions and other important technical
information, please refer to your O
Brand or InDuo

™

Brand Owner’s Booklet. IF YOU

NE TOUCH

®

Ultra

HAVE QUESTIONS ABOUT THE USE OF ANY LIFESCAN
PRODUCT, PLEASE CONTACT LIFESCAN CUSTOMER
SERVICES AT 1 800 227-8862.

References

Limitations

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NE TOUCH Ultra Test Strips give accurate results when

the following limitations are observed:

• The test strips should not be used for the testing
of newborns.

• The 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.

• Extremes in hematocrit may affect test results.

2

Hematocrit levels less than 30% may cause falsely
high readings and hematocrit levels greater than 55%
may cause falsely low readings. If you do not know
your hematocrit level, consult your healthcare profes­sional.

NE TOUCH Ultra Test Strips may be used at altitudes

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up to 10,000 feet without an effect on test results.
Accurate results were demonstrated in clinical studies
performed at altitudes up to 1,640 feet and in studies
simulating altitudes up to 10,000 feet.

Healthcare professionals— please note these additional
limitations:

• Fresh capillary blood may be collected into heparin­containing test tubes if the blood is used within
minutes. Do not use other anticoagulants or
preservatives.

1. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual.
Philadelphia: Lea and Febiger (1989), 138.

2. 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 LifeScan product. For assistance, please
contact LifeScan Customer Services at 1 800 227-8862.

Distributed by:
LIFESCAN, INC.
Printed in U.S. 10/02

Milpitas, CA 95035

AW 060-181-08B
© LIFESCAN, INC. 2001