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

Regulatory Information
As with any hearing aid, misuse of the tinnitus therapy instrument could present some
potentially harmful effects. Care should be taken to prevent the unauthorized use and
to keep the hearing aid out of the reach of children and pets.
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the recommendations below, your exposure to sound energy has the
potential to exceed noise exposure limits. You should not use your hearing aid
for more than sixteen (16) hours a day if your hearing aid is set at the maximum
output level, nor should you use your hearing aid if your Miracle-Ear
Professional has set the hearing aid at levels that exceed your comfort level.
Important Notice for Prospective Sound Generator Users
Good health practice requires that a person with tinnitus have a medical evaluation
by a licensed physician (preferably a physician who specializes in diseases of the ear)
before using a sound generator. Licensed physicians who specialize in diseases of the
ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists.
The purpose of a medical evaluation is to assure that all medically treatable
conditions that may affect tinnitus are identified and treated before the sound
generator instrument is used.
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TINNITUS TECHNICAL DATA
Custom Tinnitus
in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth
Hearing Care
®
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. They also contain a radio
transceiver utilizing Near Field Magnetic Induction operating on 10.281 MHz with
maximum induced magnetic field strength of -5 dBuA/m at a measurement distance
of 10 meters with 8-DPSK transmission modulation. The receiver section of the NFMI
radio has a bandwidth of 400 kHz.
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.
Regulatory Information
Technology Maximum Output = 87 dB SPL (typical) when measured
™
® Low Energy wireless
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