Regulatory Information
Regulatory Information
17
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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
™
fullpower RIC/BTE & custom AV 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
™
fullpower RIC/BTE & custom AV is
3 years.
The Miracle-EarCHARGE
™
fullpower RIC/BTE & custom AV have been tested to, and
have passed, the following emissions and immunity tests:
• IEC 60601-1-2 radiated and conducted emissions requirements for a Group 1
Class B device as stated in CISPR 11.
• Harmonic distortion and voltage fluctuations affecting the power input source as
stated in Table 2 of IEC 60601-1-2.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz as
well as higher field levels from communications devices as stated in Table 9 of IEC
60601-1-2.
• Immunity to power frequency magnetic fields at a field level of 30 A/m and
proximity magnetic fields as stated in Table 11 of IEC 60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air
discharge.
• Immunity to Electrical fast transients on the power input at a level of +/- 2 kV at a
100 Hz repetition rate.
• Immunity to Surges on the power input of +/- 1 kV line to line.
• Immunity to conducted disturbances induced by RF fields on the power input as
stated in Table 6 of IEC 60601-1-2.
• Immunity to voltage dips and interruptions on the power input as stated in Table 6
of IEC 60601-1-2.
