Regulatory Information
Regulatory Information
55
54
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the following recommendations, your exposure to sound energy has the
potential to exceed noise exposure limits. You should not use your hearing device for
more than sixteen (16) hours a day if your device is set at the maximum output level,
nor should you use your device if your Miracle-Ear
®
Hearing Care Professional has set
the device 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.
TINNITUS TECHNICAL DATA
Custom 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 -4 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 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
The Miracle-EarCHARGE
™
start custom 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.
