46 | Regulatory Information
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�
TINNITUS TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3�22 or IEC 60118-7�
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth® Low Energy
wireless technology operating in the 2�4-2�4835 GHz frequency band with
a maximum effective radiated power of -9 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�
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air
discharge�
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