Operations Manual
42 | Regulatory
Information
Regulatory Information | 43
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
tr
eatable
conditions that may affect tinnitus are identified and treated before the sound
generator instrument is used.
REGULATORY
NOTICES
FCC
NOTICE
This device complies with part 15 of the FCC rules and with
ISED
Canada’s
license-exempt
RSS
standard(s).
Operation is subject to the following
two
conditions:
(1)
This device may not
cause
harmful interference, and
(2)
this device
must accept any interference received, including interference that may cause
undesired operation of the device.
Note: The manufacturer is not responsible for any radio or TV interference caused
by unauthorized modifications to this equipment.
Such
modifications could
void
the
user’s
authority to operate the equipment.
Note FCC/IC
Cet
appareil est confor me
à
la
partie
15
des règles
de la
FCC
et
avec
les
normes RSS
de
licence d’Industrie Canada.
Le
fonctionnement est
soumis à
deux conditions: (1)
Cet
appareil
ne doit
pas causer
d’interférences
nuisibles
et
(2)
cet
appareil
doit
accepter
toute
interference reçue,
y
compris les interférences
qui
peuvent causer des
fonctionnements
du dispositif.
NOTE:
Le manufacturier n’est pas responsa ble
de l’interférence créée par la
modification
de cet
équipement lors
de l’écoute du téléviseur ou de la radio.
De telles modifications pourraient entrainer la révocation de l’autorité de
l’utilisateur
à opérer cet
équipement.
TECHNICAL
DA
T
A
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 -7.5 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 communication devi ces 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.
Hereby,
Starkey
Hearing Technologies
declares
that the products listed above
are
in compliance with the
essential
requirements and other relevant provisions of
Directive 2014/53/EU. A copy of the Declaration of Confor mity can be obtained
from the
addresses
on the following page or
docs.starkeyhearingtechnologies.com
WIRELESS NOT
ICES
FCC ID: EOA-24LIVIOB13A
IC: 6903A-24LIVIOB13A (Livio BTE 13, Via BTE 13, AGXsliv BTE 13, Esentia BTE
13, Livio AI BTE 13, Via AI BTE 13, AGXsliv AI BTE 13, Esentia AI BTE 13)
Starkey Hearing
Technologies
6700 Washington Ave. South
Eden
Prairie,
MN 55344 USA
STARKEY Laboratories (Germany) G.m.b.H
Weg beim Jäger 218-222
22335 Hamburg, Germany
Waste from electronic equipment
must be handled according to local
r
egulations.
Consult Operations Manual