Regulatory Information | 43
42 | Regulatory Information
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 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.
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 and charger should be stored within the temperature and
humidity ranges of -10°C (14°F) to +45°C (113°F) and 10%-95% rH.
The charging temperature range is between 0°C (32°F) and 40°C (104°F).
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 40°C (104°F). At the maximum
operating temperature of 40°C (104°F), the hearing aid case temperature may
reach 43°C (109°F).
Cautions:
• If the charger is hot, do not touch it until cool.
• If the product is not working, do not disassemble. Due to a shock hazard,
please send in for repair.
• Keep out of reach from children. Do not ingest anything in the package,
including desiccant, cleaning tool, etc.
• Any cords and AC adapters must be approved or listed by a Nationally
Recognized Testing Laboratory.
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.
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.
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 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 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.
DO NOT OPEN HEARING AID OR CHARGER,
NO USER-SERVICEABLE PARTS INSIDE
The Starkey Hearing Technologies Charger has a rating of IP 5X per IEC 60529.
This means that the Starkey Hearing Technologies Charger is protected
from dust.
The service life of the Starkey Hearing Technologies Charger is 3 years.
