Starkey Hearing Technologies Control Surface BTE 312, Operation Manual

Page: 33 / 40

*Applies to wireless hearing aids only.
Regulatory Information | 33
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 aids 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 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. 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.
Your hearing aids 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%-95% rH.
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50
o
C (122
o
F).
Use on Aircrafts
*
The optional wireless capabilities that may be featured in your hearing aids can be
used on an aircraft as hearing aids are exempt from the rules applied to other
personal electronic aids on an aircraft.
International Use
*
Your hearing aids are approved to operate at a radio frequency that is 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
to other electronic instruments, or other electronic instruments may cause
interference to your hearing aids.