PURPOSE AND SCOPE OF IFU
This IFU is designed to help hearing care professionals
trained in accordance with local educational requirements
understand the use and care of the Slim Headpiece
Magnets and to troubleshoot problems.
Limitations and Contraindications
As the Slim Headpiece Magnets are a component of
the HiResolution
contraindications stated for the HiResolution Bionic Ear
System are applicable: Deafness due to lesions of the
acoustic nerve or central auditory pathway; cochlear
ossification that prevents electrode insertion; absence of
cochlear development.
Precautions, Cautions, and Warnings
•
This device should be used only by the individual for
whom it is prescribed.
•
CHOKING HAZARD: Contains small parts that pose
a hazard of inhalation, choking, or ingestion. If any
parts are swallowed or inhaled, consult a physician
or hospital immediately.
•
Do not leave children unattended with or allow children
to play with the Slim HP or Slim HP Magnets.
•
Do not allow children to place the Slim HP or Slim HP
Magnets in the mouth or nose.
•
The large Slim HP Color Cap is for use by recipients
older than 3 years of age, as this color cap and the
Slim HP magnet may become displaced upon dropping.
Bionic Ear System, the following
TM
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