OneTouch Select User manual

NOTE: Refer to your system’s owner’s booklet for detailed information on
preparing the lancing device and blood sample collection.
To obtain a drop of blood, follow these steps:
Step 1: Select the puncture site. You may obtain a blood drop from the
fingertip, palm, or forearm. Wash your hands and the puncture site with
warm, soapy water. Dry them thoroughly.
Step 2: Lance the puncture site.
Obtain a drop of blood. Do Not squeeze the puncture site excessively.
At times, results obtained at the forearm or palm may be different from a
fingertip measurement. Talk to your health care professional before you begin
using your forearm or palm for sampling.
NOTE: Confirm if you have the correct cap for alternate site testing.
If you are testing: Use blood sample from your:
Routinely before meals Fingertip, forearm, or palm
Prior to or more than two Fingertip, forearm, or palm
hours after:
• a meal
• a rapid-acting insulin injection
or insulin pump bolus
• exercise
When your blood glucose is Fingertip
changing rapidly, such as:
• within two hours after a meal
• within two hours after a
rapid-acting insulin injection
or insulin pump bolus, or
• during or within two hours
after exercise
When you are concerned about Fingertip
the possibility of hypoglycemia
CAUTION: Do Not test on forearm or palm when:
• You think your blood glucose is rapidly falling, such as within two hours
of exercise or a rapid-acting insulin injection or insulin pump bolus.
Testing with a fingertip sample may identify a hypoglycemic (low blood
sugar) level sooner than testing with a forearm or palm sample.
• It has been less than two hours after a meal, a rapid-acting insulin
injection or insulin pump bolus, physical exercise, or you think your
glucose level is changing rapidly.
• You are concerned about the possibility of hypoglycemia (insulin
reactions), such as when driving a car. This is especially important if you
suffer from hypoglycemia unawareness (lack of symptoms to
indicate an insulin reaction).
Remember: Consult with your health care professional before using your
forearm or palm for testing.
NOTE: For detailed information on the testing procedure including
blood sample collection and coding your meter, please refer to the
owner’s booklet that came with your system.
Step 1: Insert test strip. Remove a test strip and recap the vial
immediately. Insert the test strip into the test port. Make sure the
three contact bars are facing you and the arrow is pointing down.
Push the test strip in as far as it will go. Meter turns on automatically.
Be sure the meter and test strip code match.
Step 2: Apply sample. When the flashing apply sample symbol appears on
the display, touch and hold the drop of blood to the narrow channel in the
top edge of the test strip. Keep holding the blood drop to the top edge of the
test strip until the confirmation window is full.
• Do Not apply sample to the top of the test strip.
• Do Not move the test strip in the meter during a test.
• Do Not press the test strip against your puncture site (fingertip, forearm, or
palm).
• Do Not apply a smeared sample.
If the confirmation window does not fill completely before the meter begins to
count down, Do Not add more blood to the test strip; discard the test strip
and retest. If the confirmation window is not full, you may get an error
message or an inaccurate test result. If you have trouble filling the test strip,
contact LifeScan Customer Service for assistance.
Step 3: Accurate results in just 5 seconds. Your blood glucose test result
will appear after the meter counts down from 5 to 1.
WARNING: Check that the unit of measure is correct (mg/dL).
If the unit of measure is not correct, call 1 800 227-8862.
Blood Sample Collection
Choosing the Right Sampling Site at the Right Time
Blood Glucose Testing
IMPORTANT: Please read this information and your OneTouch®Select™
Meter Owner’s Booklet before using OneTouch®Select™Test Strips. Do
Not use your OneTouch®Select™Test Strips if your vial is open or dam-
aged in any way as this could lead to error messages or blood
glucose values that read higher than the actual value. Call LifeScan
Customer Service at 1 800 227-8862 immediately if the test strip vial is
open or damaged or if these instructional materials or your meter
results seem unclear.
AW 06487301A
Test Strips
For whole blood glucose testing with the OneTouch®Select™Meter.
Test Strips
OneTouch®Select™Test Strips are used with the OneTouch®Select™Meter for
quantitatively measuring glucose in fresh capillary whole blood. The
OneTouch®Select™Test Strips and meter are intended for self testing outside
the body (in vitro diagnostic use) by people with diabetes at home and health
care professionals in the clinical setting, as an aid to monitor the effectiveness
of diabetes control. OneTouch®Select™Test Strips and meter are for use on the
finger, palm, and forearm.
• Store the test strip package in a cool dry place not above
86°F (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 place.
• Do Not open test strip vial until you are ready to test.
• After removing a OneTouch®Select™Test Strip from the
vial, immediately replace the vial cap and close it 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 (3 months after first opening the vial) on the vial
label when you first open it.
• Do Not use test strips beyond the expiration (printed on package) or
discard date, whichever comes first, because they may cause inaccurate
results.
• 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 a OneTouch®Select™Test Strip in any way.
• OneTouch®Select™Test Strips are for single use only. Never reuse a test
strip that had either 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®Select™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.
• Code the OneTouch®Select™Meter to match the
code number printed on the OneTouch®Select™Test
Strip vial.
CAUTION: Matching the code on the meter and
the code on the test strip vial is essential to obtain
accurate results. Each time you test, check to make
sure the code numbers match. (Figure A)
• Check that the meter is showing the correct unit of measure before each
test. The unit of measure is either mg/dL or mmol/L. Refer to the owner’s
booklet for the correct unit of measure. If the unit of measure is not correct,
call 1 800 227-8862.
• Use only OneTouch®Select™Test Strips with the OneTouch®Select™Meter
to obtain accurate results.
• If you are experiencing symptoms that are not consistent with your blood
glucose test results AND you have followed all instructions described in
your OneTouch®Select™Meter Owner’s Booklet, call your health care
professional.
• Never ignore symptoms or make significant changes to your diabetes
control program without speaking to your health care professional.
Materials provided: OneTouch®Select™Test Strips.
Materials required but not provided: your meter, owner’s booklet, lancing
device, optional clear cap, and a new, sterile lancet.
Test Procedure for Blood Glucose Measurement
Precautions to Obtain Accurate Results
Storage and Handling
Intended Use
(Figure A - Example)
(Example)
Flip Top Vial
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The OneTouch®Select™Meter displays 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), 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 health care professional’s recommendations. Although this
message could be due to a test error, it is safer to treat first, then do another
test. If your test result is above 600 mg/dL (33.3 mmol/L), a warning message
will appear indicating a high glucose level. This may indicate severe
hyperglycemia (high blood glucose). You should retest your glucose level and
if the message appears again, call your health care professional immediately.
Blood glucose management requires the help of a health care 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:1
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 am Greater than 70 Greater than 3.9
If You Get Unexpected Results:
If your blood glucose result is less than 70 mg/dL (3.9 mmol/L) indicating
low blood glucose or higher than 180 mg/dL (10.0 mmol/L) indicating high
blood glucose, you should contact and follow your health care professional
treatment advice.2If 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 owner’s booklet, call your health care
professional. Never ignore symptoms or make significant changes to your
diabetes control program without speaking to your health care professional.
Use only OneTouch®Select™Control Solutions
For complete details about checking the system, refer to your owner’s booklet.
When to do a Control Solution Test:
• At least once a week
• When you begin using a new vial of test strips
• Whenever you suspect that the meter or test strips are not working properly
• If you have had repeated unexpected blood glucose results
• If you drop the meter
If control solution test results fall outside of the range printed on the test strip
vial, repeat the test and refer to your owner’s booklet.
CAUTION: If you continue to get OneTouch®Select™Control Solution
test results that fall outside the range printed on the vial, your meter may
not be functioning properly. Do Not use the meter to test your blood until
you get a control solution test result that falls within the range. If you
continue to have problems, call 1 800 227-8862.
OneTouch®Select™Test Strips give accurate results when the following
limitations are observed:
• Do Not use for the diagnosis of diabetes or 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.
• Hematocrit is the percentage of red blood cells in the blood. Extremes in
hematocrit may affect test results.3Hematocrit 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 health care professional.
• OneTouch®Select™Test Strips may be used at altitudes up to 10,000 feet
(3048 meters) without an effect on test results. Accurate results were
demonstrated in clinical studies performed at altitudes up to 5,280 feet
(1609 meters) and in studies simulating altitudes up to 10,000 feet (3048
meters).
Health care 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 700 mg/dL (18.1 mmol/L) and
triglycerides up to 3000 mg/dL (33.9 mmol/L) do not affect the results.
Grossly lipemic patient samples have not been tested and are not
recommended for testing with the OneTouch®Select™Meter.
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.
Test Results
Infection Control
Limitations of Procedure
Checking the System
Range of Expected Values
AW 06487301A
© 2007 LifeScan, Inc.
Distributed by:
LifeScan, Inc.
Milpitas, CA 95035
Rev. date: 08/2007
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. 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®Select™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.
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.
The OneTouch®Select™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®Select™Meter and displayed as
your blood glucose result. The strength of this current changes with the
amount of glucose in the blood sample.
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.
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 Analyzer, a laboratory
instrument. The following results were obtained by 163 diabetic patients at 3
clinical centers:
Slope 0.979
y-intercept -3.4 mg/dL (-0.2 mmol/L)
Correlation coefficient (r) 0.985
No. of samples 163
Range tested 43–486 mg/dL (2.4–27.0 mmol/L)
This study shows that the OneTouch®Select™Meter compares well with a
laboratory method.3
Precision:
This study shows a variability from test strip to test strip in blood tests of
3.0% or less.
IMPORTANT: For a complete description of operating instructions and
other important technical information, please refer to the owner’s
booklet that came with your system. IF YOU HAVE QUESTIONS ABOUT
THE USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT LIFESCAN
CUSTOMER SERVICE AT 1 800 227-8862.
1. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and
Febiger (1989), p. 138.
2. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York: Simon
and Schuster (1995), p. 158.
3. 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 satisfied with this
product, contact your authorized LifeScan representative at
1 800 227-8862.
References
Performance Characteristics
Reagent Composition
Test Principle
Total Precision Control 36 mg/dL (2.0 mmol/L) CV = 3.2%
Control 110 mg/dL (6.1 mmol/L) CV = 2.1%
Control 337 mg/dL (18.7 mmol/L) CV = 2.3%
Within Run Precision Bloodav 42 mg/dL (2.3 mmol/L) CV = 3.0%
Bloodav 106 mg/dL (5.9 mmol/L) CV = 1.8%
Bloodav 139 mg/dL (7.7 mmol/L) CV = 1.5%
Bloodav 224 mg/dL (12.4 mmol/L) CV = 1.5%
Bloodav 355 mg/dL (19.7 mmol/L) CV = 1.6%
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