Lifescan OneTouch Select Manual

In vitro diagnostic. For self-testing.
For whole blood glucose testing with the OneTouch SelectSimple® Meter.
IMPORTANT: Please read this information and your OneTouch
SelectSimple® Meter Owner's Guide before using OneTouch Select®
Test Strips. Do Not use your OneTouch Select® Test Strips if your vial
is open or damaged 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 1800 225544 immediately if the test
strip vial is open or damaged or if these instructional materials or your
meter results seem unclear.
Intended Use
OneTouch Select® Test Strips are used with the OneTouch SelectSimple®
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 healthcare 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.
Storage and Handling
• Store the test strip package in a cool dry place not above 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 (6 months after first opening the
vial) on the vial label when you first open it.
• Do Not use test strips beyond the expiry (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.
Precautions to Obtain Accurate Results
• 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 Guide for the correct unit of measure. If the unit of measure is
not correct, call the customer service at 1800 225544.
• Use only OneTouch Select® Test Strips with the OneTouch SelectSimple®
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 SelectSimple® Meter Owner's Guide, call
your healthcare professional.
• Never ignore symptoms or make significant changes to your diabetes
control programme without speaking to your healthcare professional.
Test Procedure for Blood Glucose Measurement
Materials provided: OneTouch Select® Test Strips.
Materials required but not provided: your meter, Owner's Guide, lancing
device, optional clear cap, and a new, sterile lancet.
Blood Sample Collection
NOTE: Refer to your system's Owner's Guide 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.
Choosing the Right Sampling Site at the Right Time
At times, results obtained at the forearm or palm may be different from
a fingertip measurement. Talk to your healthcare professional before you
begin using your forearm or palm for sampling.
NOTE: Confirm if you have the correct cap for alternative site testing.
If you are testing:
Routinely before meals
Prior to or more than two
hours after:
• a meal
• a rapid-acting insulin injection
or insulin pump bolus
• exercise
When your blood glucose is
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
the possibility of hypoglycaemia
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 hypoglycaemic (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 hypoglycaemia (insulin
reactions), such as when driving a car. This is especially important if
you suffer from hypoglycaemia unawareness (lack of symptoms to
indicate an insulin reaction).
Remember: Consult with your healthcare professional before using your
forearm or palm for testing.
Flip Top Vial
(Example)
Use blood sample from your:
Fingertip, forearm, or palm
Fingertip, forearm, or palm
Fingertip
Fingertip
Select
Blood Glucose Testing
NOTE: For detailed information on the testing procedure including
blood sample collection and, for certain meter models, coding your
meter, please refer to the Owner's Guide 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.
Use only OneTouch Select® Test Strips (Code 25 only) with your OneTouch
SelectSimple® Meter.
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 customer service at 1800 225544 for assistance.
Step 3: Accurate results in just 5 seconds.
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 customer service at 1800 225544.
Test Results
The OneTouch SelectSimple® Meter displays results between 20 and
600 mg/dL. If your test result is lower than 20 mg/dL, a warning or error
message will appear indicating a low glucose level. This may indicate severe
hypoglycaemia (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, then do
another test. If your test result is above 600 mg/dL, a warning or error
message will appear indicating a high glucose level. This may indicate
severe hyperglycaemia (high blood glucose). You should retest your glucose
level and if the message appears again, call your healthcare professional
immediately.
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
Before breakfast
Before lunch or dinner
1 hour after meals
2 hours after meals
Between 2 and 4 am
If You Get Unexpected Results:
If your blood glucose result is less than 70 mg/dL indicating low blood
glucose or higher than 180 mg/dL indicating high blood glucose, you
should contact and follow your healthcare professional treatment advice.
If 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 Guide, call your healthcare professional. Never
ignore symptoms or make significant changes to your diabetes control
programme without speaking to your healthcare professional.
Checking the System
Use only OneTouch Select® Control Solutions
For complete details about checking the system, refer to your Owner's Guide.
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 Guide.
If you continue to get OneTouch Select® Control Solution
CAUTION:
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 customer service at 1800 225544.
Limitations of Procedure
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.
• Haematocrit is the percentage of red blood cells in the blood. Extremes
in haematocrit may affect test results.
may cause falsely high readings and haematocrit levels greater than 55%
may cause falsely low readings. If you do not know your haematocrit level,
consult your healthcare professional.
• OneTouch Select® 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 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 SelectSimple® Meter.
®
Test Strips
Your blood glucose test result will
1
Range, mg/dL Range, mmol/L
70–105 3.9–5.8
70–110 3.9–6.1
Less than 160 Less than 8.9
Less than 120 Less than 6.7
Greater than 70 Greater than 3.9
Haematocrit levels less than 30%
3
2