Regulatory Information; Safety Information - Miracle-Ear EarENERGY 5 BTE R EV User Manual

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, or other oxygen-rich environments.
Your hearing aids are classified as a Type B applied part under the IEC 60601-1
medical device standard.
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Regulatory Information
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 and
95% rH
45°C
transported within the temperature and humidity ranges of
10% rH
-10°C
-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.
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