Regulatory Information; Safety Information; Intended Use - Miracle-Ear CHARGE start RIC/BTE Guia Del Usuario

Regulatory Information

Safety Information

INTENDED USE:

Your Miracle-EarCHARGE
and custom AV chargers 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 instruments 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 Miracle-EarCHARGE
™
are classified as a Type B applied part under the IEC 60601-1 medical
device standard.
Your charger should not be used during an MRI procedure or in a
hyperbaric chamber, or other oxygen-rich environments.
Your 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
95% rH
transported within the temperature, humidity,
10% rH 45 C
-10 C and pressure ranges of -10°C (14°F) to +45°C
(113°F),10%-95% rH, and 70 kPa – 106 kPa
106 kPa
(equivalent to altitudes from 1,200 ft (380 m)
below sea level to 10,000 ft (3,000 m).
70 kPa
The charging temperature range is between 0°C (32°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.
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start RIC/BTE
™
start RIC/BTE and custom AV chargers
Regulatory Information
• 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.
We are required by regulations to provide the following warnings:
WARNING:
Use of wireless hearing aids or charger 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 or charger 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 or charger, degradation of the performance of your hearing
aid or charger could result. If this occurs, move away from the
communications equipment.
DO NOT OPEN HEARING AID OR CHARGER,
NO USER-SERVICEABLE PARTS INSIDE
The Miracle-EarCHARGE start RIC/BTE AV charger and
™
Miracle-EarCHARGE custom charger have a rating of IP 21 per
™
IEC 60529. This means the unit is protected against solid objects
over 12 mm, such as fingers and falling water drops, such as
condensation.
The service life of both the Miracle-EarCHARGE
charger and Miracle-EarCHARGE
start RIC/BTE AV
™
™ custom AV charger is 3 years.
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