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Additional guidance
Intended use
The Remote Control 2.0 is an accessory to a wireless air
conduction hearing aid. It is intended to let a user remotely
make volume and program adjustments to an air conduction
hearing aid.
The Remote Control 2.0 is classified as a Type B applied part
under the IEC 60601-1 medical instrument standard.
The Remote Control 2.0 is 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.
The Remote Control 2.0 is designed to be cleaned with a
damp cloth moistened with soapy water.
If you use other medical devices or wear implantable medical
devices such as defibrillators or pacemakers and are concerned
that your Remote Control 2.0 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. The Remote Control 2.0 should not
be used during an MRI procedure or in a hyperbaric chamber.
The Remote Control 2.0 is not formally certified to operate in
explosive atmospheres such as may be found in coal mines or
certain chemical factories.
Clinical benefit
The accessory itself does not provide a direct clinical benefit.
An indirect clinical benefit is provided by enabling the parent
device (wireless hearing aids) to achieve their intended
purpose.
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