Regulatory Information | 47 46 | Regulatory Information
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 that may be found in coal mines or certain chemical
factories. The hearing aids are not designed to be subjected to
environments such as an oven or microwave.
10
95
-10 C
45 C
Your hearing ands should be stored and
transported within the temperature, humidity,
and pressure ranges of -10°C (14°F) to +45°C
(113°F),10%-95% rH, and
70 kPa – 106 kPa (equivalent to altitudes from 1,200
ft (380 m) below sea level to 10,000 ft (3,000 m).
The charging temperature range is between 10°C (50°F) and 40°C
(104°F) and between 10%-95% rH and 70 kPa - 106 kPa.
Your hearing aids are designed to operate beyond the range of
temperatures comfortable to you, from 0°C (32°F) up to 40°C
(104°F).
CAUTION: 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.
Any serious incident that has occurred in relation to your Starkey
device should be reported to your local Starkey Laboratories, Inc.
representative. 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 recurrence.
*Applies to wireless hearing aids only.
CAUTIONS:
• If the product 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.
Clinical benefit
The hearing aid is designed to provide better speech
understanding to help ease communication with the aim of
improving quality of life.
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 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.
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