Regulatory Information
Regulatory Information
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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 Miracle-EarCONNECT
™
5/4/3 13 SP BTE EV is 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 not formally
certified to operate in explosive atmospheres such as coal mines or certain chemical
factories. Your hearing aids are classified as a Type B applied part under the IEC
60601-1 medical device standard.
10% rH
95% rH
-40
°
C
60
°
C
Your hearing aids should be stored and transported
within the temperature and humidity ranges of -40ºC
(-40ºF) to +60ºC (140ºF) and 10 to 95 percent relative
humidity.
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50ºC (122ºF).
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 instruments on an aircraft. Your mobile device should be placed
in Airplane Mode or turned off.
International Use
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 hearing instruments, or other electronic instruments may cause
interference to your hearing aids.
