User manual

Easy•Touch
®
Test Strip Instructions
For Testing Glucose in Capillary Whole Blood
IMPORTANT: Please read this information and your
Easy•Touch
®
Glucose Monitoring System's user
manual before using Easy•Touch
®
Glucose Test Strips.
Alternate site testing (AST) should ONLY be used in the
following intervals:
• In a pre-meal or fasting state.
(more than 2 hours since the last meal)
• Two hours or more after taking insulin.
• Two hours or more after exercise.
DO NOT use AST if:
• You think your blood glucose is low.
• You are unaware of hypoglycemia.
• Your AST results do not match the way you feel.
• You are testing for hyperglycemia.
• Your routine glucose results are often uctuating.
• If you are pregnant.
Intended Use
The Easy•Touch
®
Glucose Test Strips are used with the
Easy•Touch
®
Blood Glucose Meter for quantitatively
measuring glucose (sugar) in whole blood obtained from the
ngertip, palm and forearm. The Easy•Touch
®
Glucose Test
Strips are for testing outside the body (in vitro diagnostic
use). The Easy•Touch
®
Blood Glucose Meter is intended
for use in the home and in professional settings to monitor
blood glucose levels.
Test Principle
On each test strip there is a test area containing reaction
chemicals. When blood is applied to this area, a chemical
reaction takes place, then a transient electrical current
is formed. The blood glucose concentration is calculated
based on the electrical current detected by the meter, then
the result is showed on the display. The test measures
glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3
mmol/L). The Easy•Touch
®
Glucose Test Strip is calibrated
to display the equivalent of plasma glucose values to allow
easy comparison of results with laboratory methods.
Precautions
• For in vitro diagnostic use (outside the body) only.
• Do not reuse test strips.
• Do not use test strips beyond the expiration date printed
on the package since this may cause inaccurate results.
• Discard the vial and any unused test strips 3 months
after you rst open it. Constant exposure test strips to air
may destroy chemicals in the test strip. This damage can
cause incorrect readings.
• The sample must only be applied to the tip of the test
strip. Do not apply blood or control solution to the top, left
or right sides of the test strip. This may cause inaccurate
test results.
• Use only the Easy•Touch
®
Blood Glucose Meter with the
Easy•Touch
®
Glucose Test Strips.
• Keep the test strip vial away from children. The cap is a
choking hazard. The cap or vial contains drying agents
to protect the test strips. Drying agents may be harmful if
inhaled or swallowed and may cause skin or eye irritation.
• Any change in medication based on the Easy•Touch
®
Blood Glucose Meter test results without the consent
and advice of a physician or healthcare professional
is not recommended. Consult your physician or
healthcare professional before making changes in
your treatment plan based on your blood glucose test
results.
• Severe dehydration and excessive water loss may cause
false low results. If you believe you are suffering from
severe dehydration, consult your physician immediately.
• All devices contaminated with blood should be disposed
of properly. Healthcare professionals should follow their
institution’s infection control protocols.
• If you get Easy•Touch
®
Control Solution test results that
fall outside the range printed on the test strip vial, repeat
the test with a new test strip. If the test result is still outside
the range printed on the test strip vial, the Easy•Touch
®
System may not be working properly. DO NOT use the
system to test your blood until you get a control solution
test result within the range printed on the test strip
vial label.
Storage and Handling
• Store at room temperature between 39-86 (4-30 ).
Do not refrigerate or freeze. Avoid exposing test strips to
extreme temperatures.
• Store away from direct sunlight and heat.
• Use each strip immediately after removing it from the vial.
• Store your test strips in their original vial only. The cap or
vial contains drying agents to protect the test strips. Do
not transfer test strips to a new vial or any other container.
• After removing a test strip from the vial, replace the vial
cap immediately and close it tightly.
• Do not bend, cut, or alter the Test Strip in any way.
• With clean, dry hands you may gently touch the test strip
anywhere when removing it from the vial or inserting it into
the meter.
Warning
1. Select the Puncture Site to Obtain Blood
You may obtain a blood drop from the ngertip, palm,
or forearm. If using the forearm, choose a eshy area
away from bone, visible veins and hair. If using the palm,
choose a eshy area on the palm below your thumb or
pinky nger. Select a spot with no visible veins and away
from deep lines, which may cause your blood sample
to smear. Wash your hands and the puncture site with
warm, soapy water. Dry them thoroughly. If you use an
alcohol swab, make sure the skin is dry before lancing.
To help you get a large enough drop of blood, you may
gently massage or apply warmth to the site to increase
blood ow. Press and hold the sampler against your
ngertip, palm or forearm for a few seconds, then press
the release button.
2. Blood Glucose Testing
Insert a Test Strip to the meter. The meter will turn on.
Use the Lancing Device to obtain the right size blood
drop. Refer to your Lancing Device User’s Instruction for
how to lance your nger, forearm and palm. Then obtain
a blood sample about the size of a pinhead.
Gently touch only one edge of the Test Strip to the blood
sample. You may ll the blood to the tip of test strip.
Do not apply blood to the top, left or right sides of
the test strip. Do not press the edge of the strip against
the test site. When the strip is full of blood, the meter
will “beep” or you will see the test strip chamber area
completely lled.
3. Read Results
Read the test results in an average of 5 seconds. The
result will be stored in the meter memory.
Results are displayed as mg/dL (milligrams per deciliter
of blood) or mmol/L (millimoles per liter of blood)
depending on the units you chose when you set up your
meter. To change the units displayed, see your User’s
Manual section “Setting Up the Meter.” (The mg/dL is the
standard unit in the United States. Meters used in the
United States must be set to read in mg/dL)
What Do Your Results Mean?
Normal Glucose Values
The normal fasting glucose range for a non-diabetic adult
is 70 to 110 mg/dL (3.9 to 6.1 mmol/L)
1
. One to two hours
after meals, normal glucose values should be less than 140
mg/dL (7.8 mmol/L).
2
For people with diabetes, consult your
physician or healthcare professional for the target glucose
values that are right for you.
Low Glucose Values
The Easy•Touch
®
Blood Glucose Meter displays results
between 20 and 600 mg/dL (1.1 and 33.3 mmol/L). If your
test result is lower than 20, “Low” (LO) will appear on
the meter display. This indicates severe low blood sugar
(hypoglycemia). You should immediately treat low blood
sugar as recommended by your healthcare professional.
High Glucose Values
If your test result is above 600 mg/dL (33.3 mmol/L), “High”
(HI) will appear on the meter display screen. This indicates
severe high blood sugar (hyperglycemia). You should
immediately treat high blood sugar as recommended by
your healthcare professional.
How to do the Test
See your User’s Manual for a step-by-step guide on how to
do the test.