Warnings
►
For
in vitro
diagnostic use (for use outside of the body only).
►
For single use only.
►
Healthcare professionals and other users testing multiple patients with this system should handle
everything that has comes into contact with human blood carefully to prevent transmitting infectious
diseases, including sanitized objects.
►
Please read this sheet and your Blood Glucose Monitoring System Owner’s Manual before you use this
test strip. Use only
smooze series
Test Strips with
smooze series Blood Glucose Monitoring System
to
obtain accurate results, and be covered by the manufacturer’s warranty.
►
Results may be inaccurate when testing on patients with abnormally low blood pressure or those who are
in shock.
►
Low results may be inaccurate when testing on patients in hyperglycemic-hyperosmolar state, with or
without ketosis.
►
Please do not use this Blood Glucose Monitoring System on critically ill patients.
►
Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for
advice.
Limitations
►
Hematoc
►
Xylose: Do not test blood glucose during or soon after a xylose absorption test. Xylose in the blood can
give falsely elevated results.
rit: The hematocrit level is limited to between 20% and 60%. Please ask your healthcare
professional if you do not know your hematocrit level.
►
Neonatal Use:
This test strip must not be used for the testing of newborns.
►
►
►
This test strip is used for testing fresh capillary and venous whole blood.
There are no significant interference in the presence of galactose, maltose, or fructose observed in
blood glucose tests.
Uric acid, ascorbic acid, and acetaminophen at normal blood concentration do not significantly affect
blood glucose test results.
►
Lipemic Effects: Blood triglycerides up to 2000 mg/dL (22.8 mmol/L) do not affect the results
significantly, but may affect results at higher levels.
►
Altitude Effects:
►
Use only heparin or EDTA for anticoagulation of fresh capillary or venous whole blood.
Altitudes up to 10,742 feet (3,275m) do not affect test results.
Intended Use
Professionals may use test strips to test capillary and venous whole blood; home use is limited to capillary
whole blood testing.
Storage and Handling
IMPORTANT:
Do not use the test strips if they have expired.
► Test strips expire 3 months after first opening. Write the first opening date on the test strip vial when you
first opened it.
► Store the test strips in a cool, dry place between 2°C and 32°C (35.6°F and 89.6°F) and below 85%
relative humidity.
► Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.
► Store the test strips in their original vial
ONLY
. Do not transfer them to a new vial or any other containers.
► Do not touch the test strips with wet hands.
► Use each test strip immediately after taking it out of the vial. Close the vial immediately after taking out a
strip.
► Keep the vial closed at all times.
► Do not bend, cut, or alter the test strip.
312-4117000-001
About Alternative Site Testing (AST)
Alternative site testing (AST) is when individuals check their blood glucose levels using areas of the body
other than the fingertip. The
smooze series
test strips allow AST to be performed on sites other than the fingertip.
We strongly recommend that you perform AST ONLY at the following times:
To obtain a blood sample from the alternative sites, please
rub the puncture site for approximately 20
seconds before following
the procedures of “Testing Your Blood Glucose”.
Do
NOT
use AST if:
IMPORTANT:
There are limitations for performing AST. Please read the
smooze series
Blood Glucose
Monitoring System Owner’s Manual and consult your doctor before you perform AST.
■ During 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.
■ You think your blood glucose is low.
■ You may not notice if you are hypoglycemic.
■ Your AST results are inconsistent with the way you feel.
■ You are testing for hyperglycemia.
■ Your routine glucose results often fluctuate.
smooze series
test strips, when used together with
smooze series Blood Glucose Monitoring System
,
allow your blood glucose levels to be measured by yourself at home or by healthcare professionals. It
uses fresh whole blood samples from the finger, and the following areas: the palm, forearm, upper-arm,
calf, and thigh. This system is not intended for use in the diagnosis or screening of diabetes mellitus.
Blood Glucose
Test Strips
Series
