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Additional guidance 35
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Additional guidance
Intended Use
The Remote Microphone + is an accessory to a 2.4 GHz wireless
air conduction hearing aid. It is intended as a wireless transmitter
of sound from a variety of audio sources to air conduction
hearing aids. When worn by a distant speaker in noisy environments,
it functions as an assistive listening device. It also connects to loop
signals, FM signals when an Europin FM receiver is attached, analog
line-in audio, and standard Bluetooth audio.
The Remote Microphone + is classified as a Type B applied part under
the IEC 60601-1 medical instrument standard.
The Remote Microphone + 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 Microphone + 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 Microphone + 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 Microphone + should not be used during an MRI procedure
or in a hyperbaric chamber. The Remote Microphone + 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.
Use on Aircrafts
The Remote Microphone + should not be used on aircrafts unless
specifically permitted by the flight personnel.
International Use
The Remote Microphone + is approved to operate at radio frequencies
that are specific to your country or region and might not be approved
for use outside your country or region.
Be aware that operation during international travel may cause
interference with other electronic devices, or other electronic devices
may cause interference with your Remote Microphone +.
10% rH
95% rH
-10 C
45 C
Your Remote Microphone + is designed to
operate, be stored, and be transported within
the temperature range of -10˚C (14˚F) to 45˚C
(113˚F) and relative humidity range of 10%-95%,
and altitude limits 70 kPa – 106 kPa (equivalent
to altitudes from 1,200 ft (380 m) below sea level
to 10,000 ft (3,000 m).
We are required by regulations to provide the following warnings:
Intended use
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