Troubleshooting Guide

44 | Regulatory Information Regulatory Information | 45
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 dischar ges .
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 standar d .
Your hearing aids are not formally certified to operate in explosive atmospheres
that may be found in coal mines or certain chemical factories .
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 devices on an aircraft .
International Use
*
The optional wireless capabilities that may be featured in your hearing aids are
approved to operate at a radio frequency 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
devices, or other electronic devices may cause interference to your hearing aids .
We are required by regulations to provide the following warnings:
WARNING: Use of wireless hearing aids directly next to other electronic
equipment should be avoided because it could result in improper performance . If
such use is necessary , note as to whether your hearing aids and the other
equipment are operating normally .
WARNING: Use of accessories, components or replacement parts other
10% rH
95% rH
-10 C
45 C
Your hearing aids should be stored within the temperature
and humidity ranges of -40°C (-40°F) to +60°C (140°F) and
10%-95% rH .
than those provided by the manufacturer of your hearing aids could result in
increased electromagnetic emissions and decreased electromagnetic immunity
and could result in degradation of performance .
WARNING: If Portable Radio Frequency communications equipment
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50 C (122 F) .
Any serious incident that has occurred in relation to your Starkey device should
be reported to your local Starkey Hearing Technologies representative and
the Competent Authority of the Member State in which you are established . A
serious incident is defined as any malfunction, deterioration in the characteristics
and/or performance of the device, or inadequacy in the device Operations
Manual/ labeling which could lead to the death or serious deterioration in the
state of health of the user , OR could do so upon recurr ence .
is used closer than 30 cm (12 inches) from your hearing aid, degradation of the
performance of your hearing aid could result . If this occurs, move away from
the communications equipment .
*Applies to wireless hearing aids only.