Oticon Medical Ponto Softband User manual

Intended use
The Ponto Softband and the Ponto SoundConnector are 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 (A) with a connector (B)
for the Ponto sound processor. The band has a built-in safety feature (C),
which is designed to open the band if it gets caught. The Ponto Softband is
available for unilateral or bilateral use.
Pictures show Softband for unilateral use.
REF: 173366, 173367, 173368, 173369, 173379, 173380, 173381,
173382, 173383, 173384, 173385, 173386, 173387, 173388, 173391,
185311, 185312, 185313, 185314, 185315, 185316, 185317, 185318,
185319, 185320, 185321, 185322, 185323, 185324
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.
The SoundConnector allows users to use their Ponto sound processor with
alternative headwear. In order to secure the best possible sound transmis-
sion, use headwear with a tight fit.
To allow for correct assembly of the SoundConnector, the material must be
no thicker than 1 mm when compressed. Once attached to the headwear,
the SoundConnector cannot be removed.
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
A
C
AB
Ponto Softband
Ponto SoundConnector™
Instructions for Use
173493UK / 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. Adjust the length to fit the
head by sliding the adjustment mechanism. Ideally there should be enough
space to fit a finger between the head and the Softband. Make sure the
band is not folded.
Connect the sound processor(s) to the connector(s) on the Softband.
The connector(s) should be placed against the skull behind the ear or any
other flat location of the skull, such as the forehead.
Talk to the user to confirm that the sound processor is working and that
they can hear. If you are uncertain, listen to it through the test rod or by
wearing the Softband yourself.
Using the Softband and the SoundConnector
It is important to make the use of the Softband/SoundConnector 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/SoundConnector
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/
SoundConnector is correctly 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!
Getting started with the SoundConnector on headwear
Identify the position of the sound processor on the headwear. In order to
secure the best possible sound transmission, use headwear with a tight fit.
Make sure to select a position that allows the SoundConnector to be in
direct contact with the skull behind the ear or on any other flat location of
the skull, such as the forehead.
Push the inner part (E) of the SoundConnector through the headwear.
Place the outer part (F) on a flat surface, with the pins facing up. Press the
inner part (E), with the headwear penetrated, against the outer part (F)
until the parts attach. You will hear a click, which will indicate that the
SoundConnector is in place.
Connect the sound processor to the SoundConnector.
Place the headwear on the users head. Talk to the user to confirm that
the sound processor is working and that they can hear.
CAUTION
The Softband, SoundConnector and sound processor should not be
used by children or persons with diminished mental capacity without
adult supervision.
The Softband and SoundConnector contain small parts that may be a
choking hazard.
The Softband or SoundConnector must never be worn on top of a
bone anchored implant during the healing period, as this can inhibit
the osseointegration.
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


Pictures show Softband for unilateral use.

E
F