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Important Information
Intended use
The CareSens N Plus BT Blood Glucose Monitoring System
is intended for the quantitative measurement of glucose in
fresh capillary whole blood samples drawn from the fingertip.
The CareSens N Plus BT Blood Glucose Monitoring System
is intended for self-testing outside the body (for
in vitro
diagnostic use) 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 Blood Glucose Test Strips are for use with the
CareSens N Plus BT Blood Glucose Meter to quantitatively
measure glucose in fresh capillary whole blood samples drawn
from the fingertip.
The CareSens Glucose Control Solutions are for use with the
CareSens N Plus BT Blood Glucose Meter and CareSens N Blood
Glucose Test Strips to check that the meter and the test strips
are working together properly and that the test is performed
correctly.
Meaning of Symbols Used:
Cautions for safety and optimum product use
• Please use this device only for the intended use described
in this User's Manual.
Important Safety Information
Limitations of CareSens N Plus BT Blood Glucose Monitoring
System
• An abnormally high or low red blood cell count (hematocrit
level over 65 % or below 15 %) may produce inaccurate
results.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hypoglycemic
hyperosmolar state, with or without ketosis.
• Dehydration (excessive water loss) may cause false low
results. If you believe you are suffering from dehydration,
consult your healthcare professional immediately.
• Altitudes of higher than 10,000 ft. (3,048 m) above sea level
may have an effect on the performance of the test strip.
• The single-patient use system is for single-patient use only
and should not be shared.
• Not for neonatal use.
• Do not use for diagnosis of or screening for diabetes
mellitus.
• Not for use on critically ill patients.
• Please follow the suggested cleaning and disinfection
procedures described in this User's Manual.
• CareSens N Blood Glucose Test Strips are intended for single
use only. They should be disposed of in an appropriate
container immediately after use.
