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INTRODUCTION
Thank you for purchasing the iHealth Wireless Smart Gluco-Moni-
toring System (the iHealth system). This manual provides
important information to help you use the system properly. Before
using this product, please read the Owner's Manual thoroughly.
INTENDED USE
The iHealth system is intended to be used for:
. Quantitative measurement of glucose in fresh capillary whole
blood samples drawn from the ngertip, palm, forearm, upper
arm, calf, or thigh
. Single person measurement only (it should not be shared)
. Self-testing outside the body (in vitro diagnostic use) by people
with diabetes at home as an aid to monitor the eectiveness of
diabetes control
The iHealth system should not be used for the diagnosis of or
screening for diabetes, or for neonatal use.
IMPORTANT SAFETY INSTRUCTIONS
Please read the following information carefully before using the
iHealth system. Always keep these instructions in a safe place for
reference.
. Misuse of the iHealth system can cause electrocution, burns, re,
and other hazards.
. The meter and lancing device are for single patient use.
. Do not use either item on multiple patients.
. Do not share the meter or lancing device with anyone, including
other family members.
. Do not place the iHealth system in or near liquid.
. Use the iHealth system only for the purpose described in the
Owner's Manual.
. Use only accessories that are supplied by the manufacturer.
. Do not use the iHealth system if it has sustained any damage or is
not working properly.
. Keep the iHealth system away from heat at all times. Do not let
the iHealth system come into contact with surfaces that are hot to
the touch.
. Do not block test port or place the iHealth system on soft
surfaces that may block them. Keep test port free from lint, hair,
debris, etc.
. Do not place anything on top of the iHealth system.
. Do not place foreign objects into any opening in the iHealth
system.
. Do not use the meter in a manner not specied by the manufac-
turer.
. All parts of the iHealth system are considered biohazards and can
potentially transmit infectious diseases, even after you have
performed cleaning and disinfection.
. Please refer to the resources identied below fo r detailed
information:
"FDA Public Health Notication: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication" (2010)
http ://www.fda.gov/MedicaIDevices/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
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