Operations Manual

Regulatory Information | 41 40 | Regulatory Information
Safety Information
INTENDED USE: An air conduction hearing aid is a wearable sound-
amplifying device intended to compensate for impaired hearing� Hearing aids are
available in multiple gain/output levels appropriate to treat hearing losses ranging
from mild to profound�
Your hearing aids are designed to comply with the most stringent Standards of
International Electromagnetic Compatibility� However, it is still possible that you
may experience interference caused by power line disturbances, airport metal
detectors, electromagnetic fields from other medical devices, radio signals and
electrostatic discharges�
If you use other medical devices or wear implantable medical devices such as
defibrillators or pacemakers and are concerned that your hearing aids might
cause interference with your medical device, please contact your physician or the
manufacturer of your medical device for information about the risk of disturbance�
Your hearing aids should not be worn during an MRI procedure or in a hyperbaric
chamber� Your hearing aids are not formally certified to operate in explosive
atmospheres such as coal mines or certain chemical factories� Your hearing aids
are classified as a Type B applied part under the IEC 60601-1 medical device
standard�
10
95
-40 C
60 C
Your hearing aids should be stored within the temperature
andhumidity ranges of -40
o
C (-40
o
F) to +60
o
C (140
o
F) and
10 to 95 percent relative humidity�
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50oC (122oF)�
Any serious incident that has occurred in relation to your Starkey device should
be reported to your local Starkey Hearing Technologies representative and the
Competent Authority of the Member State in which you are established� A serious
incident is defined as any malfunction, deterioration in the characteristics and/
or performance of the device, or inadequacy in the device Operations Manual/
labeling which could lead to the death or serious deterioration in the state of
health of the user, OR could do so upon recurrence�
Use on Aircrafts
The optional wireless capabilities that may be featured in your hearing aids can
be used on an aircraft as hearing aids are exempt from the rules applied to other
personal electronic instruments on an aircraft�
International Use
Your hearing aids are approved to operate at a radio frequency that is specific
to your country or region and might not be approved for use outside your
country or region� Be aware that operation during international travel may
cause interference to other electronic hearing instruments, or other electronic
instruments may cause interference to your hearing aids�
We are required by regulations to provide the following warnings:
WARNING: Use of wireless hearing aids directly next to other electronic
equipment should be avoided because it could result in improper performance�
If such use is necessary, note as to whether your hearing aids and the other
equipment are operating normally�
WARNING: Use of accessories, components or replacement parts other
than those provided by the manufacturer of your hearing aids could result in
increased electromagnetic emissions and decreased electromagnetic immunity
and could result in degradation of performance�
WARNING: If Portable Radio Frequency communications equipment
is used closer than 30 cm (12 inches) from your hearing aid, degradation of the
performance of your hearing aid could result� If this occurs, move away from the
communications equipment�
Required Information
The following additional information is provided in compliance with U�S� Food
and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS
A hearing aid dispenser should advise a prospective hearing aid user to
consult promptly with a licensed physician (preferably an ear specialist) before
dispensing a hearing aid if the hearing aid dispenser determines through inquiry,
actual observation, or review of any other available information concerning the
prospective user, that the prospective user has any of the following conditions:
i� Visible congenital or traumatic deformity of the ear�
ii� History of active drainage from the ear within the previous 90 days�
iii� History of sudden or rapidly progressive hearing loss within the previous
90 days�
iv� Acute or chronic dizziness�
v� Unilateral hearing loss of sudden or recent onset within the
previous 90 days�
vi� Audiometric air-bone gap equal to or greater than 15 decibels at 500
Hertz (Hz), 1,000 Hz and 2,000 Hz�
vii� Visible evidence of significant cerumen accumulation or a foreign body
in the ear canal�
viii� Pain or discomfort in the ear�