Additional Guidance | 13; Intended Use - Starkey StarLink Remote Control 2.0 User Manual

12 | Get to know your Remote Control 2.0
Possible
Symptom
causes
Hearing aids are
Indicator
not paired with
light
the Remote.
illuminates,
but
hearing
aids do not
Battery level
respond to
in hearing aid
a button
can no longer
press.
support wireless
activity.
Set of
Less than two
hearing
hearing aids
aids fail
were found
to pair
during pairing
with the
process.
Remote.
Solutions
Perform pairing
process with
your hearing aids
and Remote.
See To pair with
hearing aids on
p. 4.
Install new
hearing aid
battery.
During pairing
process, make
sure both
hearing aids are
available.

Intended use

The Remote Control 2.0 is an accessory to a wireless air
conduction hearing aid. It is intended to let a user remotely
make volume and program adjustments to an air conduction
hearing aid.
The Remote Control 2.0 is classified as a Type B applied part
under the IEC 60601-1 medical instrument standard.
The Remote Control 2.0 is 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.
The Remote Control 2.0 is designed to be cleaned with a
damp cloth moistened with soapy water.
If you use other medical devices or wear implantable medical
devices such as defibrillators or pacemakers and are concerned
that your Remote Control 2.0 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. The Remote Control 2.0 should not
be used during an MRI procedure or in a hyperbaric chamber.
The Remote Control 2.0 is not formally certified to operate in
explosive atmospheres such as may be found in coal mines or
certain chemical factories.
Clinical benefit
The accessory itself does not provide a direct clinical benefit.
An indirect clinical benefit is provided by enabling the parent
device (wireless hearing aids) to achieve their intended
purpose.

Additional guidance | 13