Important Information: Read This First; Important Health-Related Information - i-SENS CareSens N Voice 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 Voice 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 Voice Blood Glucose
Monitoring System is intended for self testing outside the body
(in vitro) by people with diabetes at home as an aid to monitor
the effectiveness of diabetes control. The system is intended to
be used by a single person and should not be shared. It is not
intended for use on neonates and is not for the diagnosis or
screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with
the CareSens N Voice 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
Voice Meter and CareSens N Single 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 Voice Blood Glucose Monitoring System is
intended for in vitro (outside the body) diagnostic use only
and for the quantitative measurement of glucose in capillary
whole blood.
• The CareSens N Voice Blood Glucose Monitoring System is
intended for use by a single user only. Do not share the meter
and lancing device with another person.
• The CareSens N Voice Blood Glucose Meter is designed to
minimize code related errors in monitoring by using the
no-coding function.
• The glucose in the blood sample mixes with special chemicals
on the test strip to produce a small electrical current. The
CareSens N Voice Meter converts this electrical current to
glucose concentration.
• The CareSens N Voice Blood Glucose Meter should be used
only with the CareSens N Single Test Strip.
• 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 (high blood sugar) or hyperosmolar state, with
or without ketosis. Critically ill patients should not be tested
with blood glucose meters.
• All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed pre-cleaning and disinfection.
• 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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