Oticon Medical Sentio 1 Mini User manual

Sentio 1 Mini
Instructions for Use
Sound processor

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The Instructions for Use
The Sentio System is intended for improvement of hearing for patients with conduc-
tive and mixed hearing losses by unilateral or bilateral fitting, and single sided
deafness. The system comprises of an implant and an externally worn sound proces-
sor. The implant is placed fully under the skin and the sound processor is retained to
the implant site with a magnet.
The Sentio 1 Mini sound processor is designed to be optimised for each individual per-
son. This will help ensuring you get the maximum benefit from your sound processor.
The Sentio 1 Mini sound processor is intended for use in homes, hospitals, health care
institutions as well as in public environments. However, make sure that cautions related
to specific situations mentioned in the “Important Information” and the “Warnings”
sections are considered.
The Instructions for Use gives you guidance on how to use and maintain your new
sound processor.

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Please read through this manual carefully to learn how to get the most out of your
sound processor. Pay extra attention to Warnings section, Important information,
Skin care and retention comfort and Sound Processor maintenance. Discuss any
questions or concerns with your hearing care professional.
Summary of Safety and Clinical Performance (SSCP) report for the Sentio System is
publicly available in the EUDAMED database.1
1 https://ec.europa.eu/tools/eudamed.
Entering key Sentio 1 Mini sound processor:
Basic UDI-DI: 57121491001185
Entering key Sentio Ti Implant:
Basic UDI-DI: 57121491001083

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The Instructions for Use ......................................................................................3
In the box...........................................................................................................8
Processor view ...................................................................................................9
The Sentio 1 bone conduction hearing system ................................................... 10
Switching the sound processor ON and OFF ...................................................... 12
When to replace the battery ...............................................................................13
How to replace the battery ................................................................................ 14
Left or right marking ..........................................................................................17
Connection ...................................................................................................... 18
Disconnection ................................................................................................. 18
Correct position ............................................................................................... 18
Skin care and retention comfort ........................................................................20
Sound processor maintenance ......................................................................... 21
Optional features and accessories ....................................................................22
Safety line ....................................................................................................... 22
Volume control ................................................................................................24
Programmes .................................................................................................... 25
Mute ................................................................................................................26
Flight mode ..................................................................................................... 27

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Use the sound processor with iPhone and iPad .................................................28
Pairing the sound processor with iPhone...........................................................29
Wireless accessories......................................................................................... 31
Sentio 1 compatible with the following articles .................................................. 32
Service and repair ............................................................................................ 33
Manufacturer’s warranty ...................................................................................34
Common problems and their possible solutions ................................................ 35
Important information ...................................................................................... 37
Regulatory compliance statements....................................................................38
Warnings.......................................................................................................... 41
Symbol clarifications ........................................................................................49
Sound and LED light indicators ......................................................................... 52

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In the box
• Sentio 1 Mini sound processor
• Sentio 1 Mini case
• Batteries (size 675)
• Safety line
• Left/right indication (blue/red)
• Tamper resistant battery lid tool

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LED (light diode)
Microphone
inlets Magnet
Processor view
Hole for
Safety line
Warning: The sound processor contains small parts that may be a choking hazard for small
children. Batteries can also be harmful if swallowed. Always keep batteries out of reach of small
children or people of diminished mental capacity. If a sound processor is accidentally swallowed,
seek medical attention at the nearest emergency department.
Push button
Battery lid
Hole for TAR
Hole for TAR

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The Sentio bone conduction hearing system
Your Sentio 1 Mini sound processor is designed to help you gain improved hearing
through direct bone conduction. The sound processor converts sound into signals
which are transmitted to the Sentio Ti Implant where they are converted into vibra-
tions. The vibrations pass through the skull bone to the inner ear where they are
perceived as sound. This works independently of the function of the ear canal and
middle ear.
Therefore, the Sentio system is a possible solution for hearing losses where there is a
problem in the outer or middle ear preventing sound from reaching the inner ear.
The Sentio hearing system can also pick up sound from one side and transfer it to the
inner ear on the opposite side. This makes it suitable for those who are deaf on one
side but have a functioning inner ear on the other side (called unilateral profound
sensorineural hearing loss or single-sided deafness).