i-SENS KetoSens, Руководство пользователя

Страница: 2 / 28

4 www.i-sens.com www.i-sens.com 5
Important Information: Read This First!
Information
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 fingertip. 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 effectiveness 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 finger.
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.
• 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.
To receive safe and optimum system benefits, please read
the entire manual contents before using the system.
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.
• “FDA Public Health Notification: Use of Fingerstick
Devices on More than One Person Poses Risk
for Transmitting Bloodborne Pathogens: Initial
Communication” (2010) http://wayback.archive-it.
org/7993/20170111013014/http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.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
• KetoSens Blood β -Ketone Test Strips are intended
for self-testing only. They should be disposed of in an
appropriate container immediately after use.