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).

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Sound
processor
Sound
processor
Implant under
the skin
Implant

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Switching the sound processor ON and OFF
Insert or remove the battery to switch the sound processor ON or OFF. To save battery
life, make sure your sound processor is switched off when you are not wearing it.
Switch ON
Insert the
battery and put
on the battery lid
to start up the
sound processor
Switch OFF
Remove the
battery lid and
battery to switch
the sound
processor off
Optional LED
Two long green
flashes indicate that
the sound processor
is turned on.

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Tamper-resistant battery lid
Sentio 1 Mini comes with a built-in tamper-resistant battery lid. To lock the tamperresistant
battery lid, insert the tip of the TAR tool into the hole on the back of the battery lid and
push lightly. Check that the lid cannot be opened to confirm that the TAR mechanism
is locked.
Insert the tip of the TAR tool from the front to unlock the tamper-resistant battery lid.
Important: The tamper-resistant battery drawer function must always be used for children under
the age of 36 months due to risk of swallowing and choking.
Lock the tamper-resistant battery lid Unlock the tamper-resistant battery lid

 
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When to replace the battery
The battery lifetime varies with usage time and sound environment. When it is time to
replace the battery, you will hear three consecutive beeps repeated in moderate
intervals. Four beeps in a descending tone indicate that the battery is running
completely out. When the battery runs low, Bluetooth®will be turned off and it will not
be possible to use wireless accessories.
Note: To make sure the sound processor is always working, bring spare batteries with you
or replace the battery before you leave home. Batteries need to be replaced more often if
you are streaming to your sound processor.
Three alternate beeps*
= The battery is running low
Four descending tones
= The battery has run out
Optional LED (can be turned on by your hearing care professional)
Orange blinks, continuously repeated, to indicate battery low.

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How to replace the battery
Sentio 1 Mini uses a size 675 zinc-air battery.
Use high-quality zinc-air batteries for optimal
performance.
1. Open
Remove the battery
lid from the sound
processor.
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 battery is accidentally swallowed, seek
medical attention at the nearest emergency department.

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3. Insert 4. Close
Insert the new battery
into the battery drawer.
Make sure the + side is
facing upwards.
Note: If the battery is
inserted incorrectly it
may damage the battery
compartment.
Close the battery lid.
The sound processor will
play a jingle. The jingle is
played when the battery
is inserted, unrelated to
the lid.
2. Uncover
Remove the sticky label
from the + side of the
new battery.
Note: Wait 2 minutes
so that the battery can
draw air, to ensure optimal
functioning.

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Left or right marking
The Sentio 1 Mini devices are non-side specific and will be programmed to the left or
right side by your hearing care professional. When using two sound processors, left
and right indication plugs can be inserted under the battery lid. Your hearing care
professional can apply these.
Blue indicator (left) Red indicator (right)

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Connection
The Sentio 1 Mini sound processor is retained to the implant under the skin by
magnetic force. To attach the sound processor to the head, place it close to the
implant site to allow the magnet in the sound processor to attract to the magnet in the
implant.
Note: No other magnet than your Sentio sound processor shall be placed over the implant
site. This may damage the implant and/or your skin.
Disconnection
The sound processor is disconnected by carefully sliding it away from the implant.
Correct position
To get optimal performance from the directional microphone system, the sound pro-
cessor should be positioned with the microphone inlets positioned horizontally. The
correct position is best ensured before the magnets in the processor and the implant
connect completely.

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Microphones
Correct position Incorrect position

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Skin care and retention comfort
The sound processor should sit comfortably and securely in place with the right bal-
ance between comfort and retention. If the magnetic force is too weak there is a risk of
the sound processor falling off too easily. If the magnetic force is too strong there is a
risk of discomfort and skin irritation.
If the sound processor causes redness or discomfort, or if the sound processor seems
to fall off frequently, contact your hearing care professional to have the magnet
exchanged.
In case of significant skin irritation, blistering, or signs of skin breakdown, you should
stop wearing the device and seek assistance from a medical professional to assess
your implant site.
Parents or caregivers are responsible for skin care and retention comfort of a child’s
implant.