Regulatory Information; Safety Information; Intended Use - Miracle-Ear CHARGE fullpower RIC/BTE Manual Del Usuario

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. Your
Miracle-EarCHARGE fullpower RIC/BTE & custom AV is 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 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.
Your charger should not be used during an MRI procedure or in a hyperbaric
chamber, or other oxygen-rich environments.
Your Miracle-EarCHARGE ™ fullpower RIC/BTE & custom AV is classified as a Type
B applied part under the IEC 60601-1 medical device standard. Your charger is not
formally certified to operate in explosive atmospheres such as may be found in coal
mines or certain chemical factories.
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Regulatory Information
Your charger should be stored and transported within
95% rH 45°C
the temperature, humidity, and pressure ranges of
10% rH -10°C
-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)
106 kPa
below sea level to 10,000 ft (3,000 m).
The charging temperature range is between 10°C
70 kPa
(50°F) and 40°C (104°F) and between 10%-95% RH and
70 kPa-106 kPa.
CAUTION:
• If the charger is hot, do not touch it until cool.
• If the charger 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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