Important Information: Read This First!
To receive safe and optimum system benefits, please read the
entire manual contents before using the system.
Intended use:
The KetoSens BT Blood β-Ketone Monitoring System is intended
to be used for the quantitative measurement of β-Ketone (beta-
hydroxybutyrate) level in capillary whole blood drawn from the
fingertip. The KetoSens BT Blood β-Ketone Monitoring Systems
are for self-testing outside the body (for in vitro diagnostic use)
in the home as an aid to monitor the effectiveness of diabetes
control program. The system is not intended for use in the
diagnosis of or screening for diabetes mellitus and is not intended
for use on neonates. This system is intended to be used by a
single person and should not be shared.
The KetoSens Blood β-Ketone Test Strips work with the KetoSens
BT Blood β-Ketone Meter to quantitatively measure Blood β-Ketone
in capillary whole blood samples drawn from the fingertip.
The KetoSens Control Solutions are intended for use with
the KetoSens BT Blood β-Ketone meter and KetoSens Blood
β-Ketone test strip to check that the meter and the test strip
are working together properly and that the test is performing
correctly.
Please use this device only for the intended use described in
•
this User's Manual.
Please follow the suggested cleaning and disinfection
•
procedures described in this User's Manual.
KetoSens Blood β-Ketone Test Strips are intended for
•
self-testing only. Follow the instructions provided by your
healthcare professional on the safe disposal of used test strips.
6 www.i-sens.com