Miracle-Ear CHARGE fullpower RIC/BTE T AV Manual Del Usuario página 8

Regulatory Information
Safety Information
Intended Use
This hearing aid charger is intended to charge lithium-ion rechargeable hearing
aids, and is to be used with the patient's selected hearing aid solution. For
information about your hearing aid, please consult the hearing aid specific user
manual.
Your Miracle-EarCHARGE ™ fullpower RIC/BTE T AV charger is designed to
operate in public and residential environments and is 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 charger 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.
The charger should not be used during an MRI procedure or in a hyperbaric
chamber, or other oxygen-rich environments.
14
Regulatory Information
The charger is not formally certified to operate in explosive atmospheres such as
may be found in coal mines or certain chemical factories.
Your charger should be stored and transported within the
95% rH 45°C
temperature and humidity ranges of -10°C (14°F) to 45°C
10% rH -10 C
°
(113°F) and 10%-95% rH.
40 C
°
The charging temperature range is between 0°C (32°F) and 40°C (104°F).
0 C
°
Your Miracle-EarCHARGE ™ fullpower RIC/BTE T AV charger is classified as a Type B
applied part under the IEC 60601-1 medical device standard.
CAUTIONS:
• Charge both the hearing aids and charger for 3.5 hours before use.
• 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.
• There is nothing edible in the package, including the desiccant, cleaning tool, etc.
• Any cords and AC adapters must be approved or listed by a Nationally
Recognized Testing Laboratory.
15