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Safety Information
Safety Information
INTENDED USE: An air conduction hearing instrument
is a wearable sound-amplifying device intended to
compensate for impaired hearing. Hearing instruments
are available in multiple gain/output levels appropriate
to treat hearing losses ranging from mild-to-profound.
Your hearing instruments are designed to comply
with the most stringent Standards of International
Electromagnetic Compatibility. However, it is still
possible that you may experience interference caused
by power line disturbances, airport metal detectors,
electromagnetic fields from other medical devices,
radio signals and electrostatic discharges.
If you use other medical devices or wear implantable
medical devices such as defibrillators or pacemakers
and are concerned that your hearing instruments
might cause interference with your medical device,
please contact your physician or the manufacturer of
your medical device for information about the risk of
disturbance.
Your hearing instruments should not be worn during
an MRI procedure or in a hyperbaric chamber.
Your hearing instruments are classified as a Type B
applied part under the IEC 60601-1 medical device
standard.
Your hearing instruments are not fully certified to
operate in explosive atmospheres that may be found
in coal mines or certain chemical factories.
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