Important Information: Read This First; Important Health-Related Information - i-SENS CareSens N User Manual

Important Information: Read This First!

To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note
the following instructions:
• Do not use the system for diagnosis or screening of diabetes.
• Use only fresh capillary whole blood samples for testing.
• Alternative site and fingertip test results may differ
significantly due to rapid changes in the blood glucose level
after eating, insulin injection or exercise.
Intended Use
The CareSens N Blood Glucose Monitoring System is intended
for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips and alternative
sites such as the forearm, palm, thigh, and calf. Alternative site
testing should be used only during steady-state blood glucose
conditions. The CareSens N Blood Glucose Monitoring System
is intended for self testing outside the body (in vitro) by people
with diabetes as an aid to monitor the effectiveness of diabetes
control. It is not intended for use on neonates and is not for the
diagnosis or screening of diabetes.
The CareSens N Blood Glucose Test Strips are for use with the
CareSens N Blood Glucose Meter to quantitatively measure
glucose in fresh capillary whole blood samples drawn from the
fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N
Meter and CareSens N Test Strips to check that the meter and
the test strips are working together properly and that the test is
performing correctly.
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Important Health-Related Information

• The CareSens N Blood Glucose Monitoring System is
intended for self-testing outside the body (in vitro diagnostic
use).
• The CareSens N Blood Glucose Meter is designed to minimize
code related errors in monitoring by using the no-coding
function.
• Glucose in blood samples reacts with the chemical in the test
strip to produce a small electrical current. The CareSens N
Meter detects this electrical current and measures the amount
of glucose in the blood sample.
• The CareSens N Blood Glucose Meter should be used only with
the CareSens N Test Strips.
• An abnormally high or low red blood cell count (hematocrit
level over 60% or below 20%) may produce inaccurate results.
• Inaccurate results may occur in severely hypotensive
(having low blood pressure) individuals or patients in shock.
Inaccurate low results may occur for individuals experiencing
a hyperglycemic-hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with blood glucose
meters.
• Inaccurate results may occur in patients undergoing oxygen
therapy.
• For questions or concerns, contact Customer Service: 1-800-
429-5001 (9 am - 9 pm EST, Mon - Sat). At all other times
or in case of emergency, please contact your healthcare
professional or emergency medical response.
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