Oticon Medical M50551 User manual

REF: M50551, M50612, M50637, M50638, M50639, M50640,
M50734, M50735, M50736, M50737, M50738, M50739
If you have any questions related to the Oticon Medical bone anchored
hearing system, please contact the manufacturer or your local representative/
hearing aid professional.
Explanation of symbols
0413
CE mark
Manufacturer
Reference number
Batch code
Rx ONLY Caution: Federal law (USA) restricts this device to sale by or on the order
of a licensed medical practitioner
Consult Instructions for Use
Caution
Hand wash
Medical Device
Unique Device Identification
UDI-DI Unique Device Identification Device Identifier
Softband
Instructions for Use
M50684UK / 2020.04
Oticon Medical AB
Datavägen 37B
SE-436 32 Askim
Sweden
Tel: [phone]
www.oticonmedical.com
0459

Getting started with the Softband
Place the Softband around the user's head and adjust the length. Make
sure that it is not too tight, as this may cause discomfort. Ideally there should
be enough space to fit a finger between the user's head and the Softband.
Initially it is better to have the band too loose rather than too tight.
Connect the sound processor to the connector disc on the Softband.
The connection disc should preferably be placed against the skull behind
the ear or other flat location of the skull, such as the forehead.
To prevent feedback (whistling sounds), make sure the sound processor
is not touching anything – including the ear itself.
Talk to the user to confirm that the sound processor is working and that
they hear. If you are uncertain listen to it through the test rod or by wearing
the Softband yourself.
Intended use
The Softband is intended for users who have not yet had implant surgery
(or for some reason cannot get an implant), but could benefit from a bone
conduction solution.
The Softband consists of an adjustable elastic band with a plastic connector
disc for the Ponto sound processor. The band has a built-in safety feature
which is designed to open the band if it gets caught. The Ponto Softband is
available for unilateral and bilateral use.
Using the Softband
It is important to make the use of the Softband a positive experience. We
recommend wearing it for about 10-15 minutes in the beginning and then
gradually increase the wearing time.
During long-term use, vary the position of the Softband on a regular basis
to avoid discomfort. Take a break for a few days, if the problem persists.
Parents or caregivers should always check that the Softband is properly
attached and positioned and that the sound processor is functioning
properly before use.
Replace the Softband if it has lost its elasticity.
Cleaning
The Softband can be washed by hand at 40°C or lower. Note that the sound
processor must NEVER be washed, as it is not waterproof!
CAUTION
The Softband and sound processor should not be used by children or
persons with diminished mental capacity without adult supervision.
The Softband contains small parts that may be a choking hazard.
The Softband must never be worn on top of a bone anchored implant
during the healing period, as this can inhibit the osseointegration.