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Intended use
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 aids are designed to operate in public and residential environments
and are designed to comply with international Electromagnetic Compatibility
emissions and immunity standards for medical devices. 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 aids 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 aids should not be worn during an MRI procedure or in a hyperbaric
chamber or other oxygen-rich environments.
Your hearing aids are classified as a Type B applied part under the IEC 60601-1
medical device standard.
Your hearing aids are not formally certified to operate in explosive atmospheres such
as may be found in coal mines or certain chemical factories.
95% rH
10% rH
-40˚C
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from -20°C (-4°F) up to 50°C (122°F).
40
Your hearing aids should be stored and transported within
60˚C
the temperature, humidity, and pressure ranges of -40°C
(-40°F) to +60°C (140°F),10%-95% rH, and 70 kPa –106 kPa
(equivalent to altitudes from 1,200 ft (380 m) below sea
level to 10,000 ft (3,000 m).
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