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Safety Information Safety Information
Safety Information
INTENDED USE: An air conduction hearing aid is a
wearable sound-amplifying device intended to compensate
for impaired hearing. Hearing aids 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.
Your hearing instruments should be stored within the
temperature and humidity ranges of -40
o
C (-40
o
F) to
+60
o
C (140
o
F) and 10 to 95 percent rH.
36


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