Important Information: Read This First - i-SENS KetoSens Manual Del Usuario

Important Information: Read This First!

To receive safe and optimum system bene ts, please read the
entire manual contents before using the system.
Intended use:
The KetoSens Blood β-Ketone Monitoring System is intended for
the quantitative measurement of β-Ketone (beta-hydroxybutyrate)
level in capillary whole blood drawn from the ngertip. The
KetoSens Blood β-Ketone Monitoring System is intended for
self-testing outside the body (in vitro) by people with diabetes
at home as an aid to monitor the e ectiveness of diabetes
control. 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
Blood β-Ketone Meter to quantitatively measure Blood β-Ketone
in capillary whole blood samples drawn from the nger.
The KetoSens Control Solutions are intended for use with the
KetoSens 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.
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Important Safety Information:
• The meter and lancing device are for single patient use. Do not
share them with anyone including other family members! Do
not use on multiple patients!
• All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed pre-cleaning and disinfection.
• 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. They should be disposed of in an appropriate
container immediately after use.
• "FDA Public Health Noti cation: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication" (2010) https://www.fda.
gov/MedicalDevices/Safety/AlertsandNotices/ucm234889.htm
• "CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens" (2010) http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html
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