Miracle-Ear EarENERGY 5 BTE R EV User Manual page 27

Regulatory Information
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth
technology operating in the 2.4-2.4835 GHz frequency band with a maximum effective
radiated power of -13 dBm using GFSK transmission modulation. The receiver section of
the radio has a bandwidth of 1.5 MHz.
This hearing aid model has been tested to, and has passed, the following emissions and
immunity tests:
• IEC 60601-1-2 radiated emissions requirements for a Group 1 Class B device as stated
in CISPR 11.
• 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 as well as
proximity magnetic fields as defined in table 11 of 60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air discharge.
The Miracle-EarCHARGE start RIC/BTE AV charger has been tested to, and has 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.
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Low Energy wireless
®
Regulatory Information
• 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.
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