Medel Me152 Series User manual

Cochlear Implants
AW35461_4.0 (English)
SONNET 2 (Me151x) and SONNET 2 EAS
(Me152x) audio processors
User Manual for

1
CHAPTER 1
Table of contents

Table of contents
2
1. Table of contents.................................................................................................. 1
2. Introduction ......................................................................................................... 5
3. Intended use– Indications– Contraindications ................................................... 7
Intended use .................................................................................................................8
Indications.....................................................................................................................9
Contraindications........................................................................................................ 10
4. SONNET 2 audioprocessor...................................................................................11
The parts of the system ............................................................................................. 12
The concept of EAS..................................................................................................... 14
Switching the audio processor ON/OFF...................................................................... 15
Telecoil ........................................................................................................................ 17
FineTuner .................................................................................................................... 18
Battery pack................................................................................................................22
Coil ..............................................................................................................................24
DL‑Coil.........................................................................................................................25
D Coil...........................................................................................................................33
Coil cable.....................................................................................................................35
Earhook.......................................................................................................................38
Microphone cover ....................................................................................................... 41
Connecting assistive listening devices........................................................................42
Wireless functionality .................................................................................................44
Flight mode .................................................................................................................45
5. Special considerations for young children.......................................................... 47
6. General precautions and warnings..................................................................... 49
General precautions for your MED‑EL Cochlear Implant System ............................... 51
Precautions for medical procedures...........................................................................57
7. Care and maintenance ....................................................................................... 59
Maintenance ...............................................................................................................60
Batteries......................................................................................................................63

Table of contents
3
8. Troubleshooting ................................................................................................. 67
Speech Processor Test Device.....................................................................................69
FineTuner .................................................................................................................... 71
Audio processor indicator light...................................................................................72
Private alert.................................................................................................................74
DL‑Coil indicator light (Link Monitoring).....................................................................75
FineTuner indicator lights ...........................................................................................77
9. Technical data .................................................................................................... 79
Audio processor ..........................................................................................................80
Coils.............................................................................................................................83
FineTuner ....................................................................................................................84
Regulatory statements................................................................................................86
Symbols.......................................................................................................................87
Disposal.......................................................................................................................89
Guidance and manufacturer’s declaration .................................................................90
10. Appendices ........................................................................................................ 93
Warranty .....................................................................................................................94
Manufacturer address.................................................................................................94
11. Contact MED‑EL ................................................................................................. 95

4

5
CHAPTER 2
Introduction

Introduction
6
This user manual provides information and instructions regarding the MED‑EL Cochlear
Implant (CI) System with the two variants of the SONNET 2 audio processor: SONNET 2
(Me151x)1and SONNET 2 EAS (Me152x)1. It includes descriptions of available parts,
wearing options, and accessories for the audio processor, as well as instructions for
troubleshooting and proper care of the external cochlear implant equipment.
This symbol indicates information that is particularly relevant for parents of
implanted children.
Important
You are the operator of your/your child‘s audio processor, therefore we recommend
that you read this manual in its entirety. Do not perform any maintenance activities
other than those described in this manual (e.g. changing batteries). When performing
these maintenance activities, always remove the audio processor from the ear.
The adjustment to a cochlear implant and adequate tting of the device are gradual
processes that occur over time. It is important to remember that your ability to hear
with your new MED‑EL Cochlear Implant System may take a little time while you
become accustomed to this new method of hearing. You may choose to work with an
aural rehabilitation specialist or other clinician to help you maximise your communica‑
tion skills using the device.
After your initial tting, you will need to return to your CI centre on a regular basis
for reprogramming. Frequent reprogramming may be required during the rst year of
implant use. This is normal and necessary, and it reects a learning process that occurs
as you become more and more accustomed to stimulation through the implant. As more
time passes, you will likely nd that you may require fewer and fewer sessions. Most
users continue to require occasional adjustments for as long as they use their implant.
Please contact your CI centre or MED‑EL with any additional questions you may have.
1 x = 0, 1, 2 or 3

7
Intended use–
Indications–
Contraindications
CHAPTER 3

Intended use– Indications– Contraindications
8
Intended use
The SONNET 2 audio processor is an external part of the MED‑EL Cochlear Implant
System. The MED‑EL Cochlear Implant System is intended to evoke auditory sensation
via electrical stimulation of the auditory pathways for severely to profoundly hearing
impaired individuals who obtain little or no benet from acoustic amplication in the
best aided condition.
Additionally, the MED‑EL Cochlear Implant System used in combination with the
FLEX24 (2) or FLEX20 electrode is intended to evoke auditory sensations via electrical
stimulation or via combined electric‑acoustic stimulation (EAS) of the auditory pathways
for partially deaf individuals, who obtain benet from acoustic amplication in the
lower frequencies only.
The MED‑EL Cochlear Implant System is also intended to evoke auditory sensations
via electrical stimulation of the auditory pathways for individuals with single‑sided
deafness, which is dened as severe to profound hearing impairment in one ear and
normal hearing or mild to moderate hearing impairment in the other ear.
The Auditory Brainstem Implant (ABI) is used for electrical stimulation of the cochlear
nucleus (CN) via an implanted stimulator and a specially designed electrode array to
evoke auditory sensations in patients with non‑functional cochlear nerves.
2 The FLEX24 electrode was formerly marketed as the FLEXEAS electrode. Implementation of the FLEXEAS name
change to FLEX24 may depend on regulatory approval and the electrode may therefore still be marketed as
FLEXEAS in some markets.

Intended use– Indications– Contraindications
9
Indications
The SONNET 2 audio processor is an external component of the MED‑EL Cochlear
Implant System and is indicated for use in patients who have been implanted with
Mi1200 SYNCHRONY or Mi1210 SYNCHRONY ST (hereafter referred to as SYNCHRONY),
Mi1000 CONCERTO (hereafter referred to as CONCERTO), SONATAti100 (hereafter referred
to as SONATA), PULSARci100 (hereafter referred to as PULSAR), C40+ or C40 cochlear
implants(3).
The SONNET 2 is indicated to be used in typical everyday environments (home, ofce,
outdoor etc.) and is appropriate for patients of any age.
The hearing aid functionality of the SONNET 2 is intended to be used by patients with
functional low frequency hearing. Post‑operative acoustic amplication (i.e. use of com‑
bined electric‑acoustic stimulation) is indicated for hearing losses between 30 dBHL and
80dBHL (when using the half gain tting rule) in the frequency range between 125Hz
and 1700Hz.
The SONNET 2 is intended to be used every day during a patient’s waking hours.
The user of a SONNET 2 does not need any special skills or elevated level of education,
however, the user (or custodian if the user is a child or a handicapped person not able
to perform the actions listed below) shall at minimum be able to perform the following
actions:
• Switching ON/OFF
• Changing batteries
• Placing/removing SONNET 2 on/from the ear
• Placing/removing coil over/from the implant site
As the SONNET 2 is a component of the MED‑EL Cochlear Implant System, all indica‑
tions stated for the MED‑EL Cochlear Implant System are applicable.
3 Not all products in this document are currently approved or available in all countries. Please contact your
local MED‑EL representative for information on current product availability in your country.

Intended use– Indications– Contraindications
10
Contraindications
A patient must not receive a SONNET 2 if the individual is known to be intolerant of
the materials used in the SONNET 2. Combined electric‑acoustic stimulation (EAS) is
contraindicated for patients unable to use acoustic amplication. For details, please
refer to chapter 9, Technical data.
The SONNET 2 and any external wireless device (e.g. FineTuner) are not intended to be
used in environments where RF transmissions are prohibited (e.g. operating theatre).
As the SONNET 2 is a component of the MED‑EL Cochlear Implant System, all contra‑
indications stated for the MED‑EL Cochlear Implant System are applicable.
NOTE: Important information related to indications, contraindications, warnings and
risks for your cochlear implant are shipped in a separate document (instruction for
use of the implant) to your clinic together with the cochlear implant. If you want to
review this information, please contact your clinic or MED‑EL.

11
SONNET 2
audioprocessor
CHAPTER 4

SONNET 2 audioprocessor
12
The parts of the system
The MED‑EL Cochlear Implant System is an active medical device that has internal
(implanted) and external parts. The internal part of the device is surgically implanted
behind the ear in the skull, while the external components are worn behind the ear or
on the body.
The external parts include the SONNET 2 audio processor and the audio processor
accessories. In its basic conguration, the SONNET 2 audio processor consists of the
control unit with the earhook attached, the battery pack (consisting of frame and
cover), the coil and the coil cable. A separate device called FineTuner facilitates access
to various audio processor functions.
The coil is held in place by magnetic attraction to the implant.
The audio processor uses batteries that provide sufcient power for both the external
and the implanted electronics. The implanted part does not contain batteries.
The SONNET 2 audio processor is available in two variants: The rst variant (product
code Me151x) is an audio processor that supports electrical stimulation only, while
the second variant (product code Me152x) additionally features acoustic stimulation
(amplication) intended to be used by recipients who have at least a certain degree of
functional low frequency hearing. Unless explicitly stated otherwise, “SONNET 2” refers
to both variants throughout this user manual.

SONNET 2 audioprocessor
13
SONNET 2 for CI audio processor
SONNET 2 for EAS audio processor
Fig. 1 Your SONNET 2 audio processor
Coil cable
Coil cable
EAS
earhook
Coil
Coil
Indicator light
Indicator light
CI earhook
Air inlets
Air inlets
SONNET 2 for CI
control unit
SONNET 2 for EAS
control unit
Microphone cover
Microphone cover
Battery pack
Battery pack
Microphone openings
Microphone openings
Ear mould
(not supplied by MED‑EL)

SONNET 2 audioprocessor
14
The concept of EAS
Cochlear implant users with low frequency hearing benet from additional acoustic
stimulation in the implanted ear as has been demonstrated in various scientic studies.
This combination of cochlear implant and acoustic stimulation is known as combined
electric‑acoustic stimulation, or EAS. The term electric stimulation refers to the cochlear
implant, while acoustic stimulation refers to the acoustic amplication unit.
Especially in listening situations with background noise (background conversations,
street noise etc.), EAS can greatly improve speech understanding. Users of combined
electric‑acoustic stimulation have also reported that sound quality and music percep‑
tion are improved compared to cochlear implant use alone.
Studies have also shown that it may take time for EAS use to show its full bene‑
t. If you are an EAS user and do not experience an immediate benet, do not be
discouraged.

SONNET 2 audioprocessor
15
Switching the audio processor ON/OFF
The battery pack cover functions as an ON/OFF switch.
You may select the following positions:
Battery pack cover pulled back: OFF
Battery pack cover completely moved over the frame: ON
Important
When trying to pull back the battery pack cover, make sure that the battery pack cover
lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked posi‑
tion, use the screwdriver provided with your SONNET 2 kit to turn it counter‑clockwise
into the unlocked position.
There is no need to completely remove the battery pack cover to switch off the audio
processor. It is sufcient to pull it back to a position where you can see the whole
labelling on the control unit (see Fig. 2).
If the audio processor should be at a temperature that is outside the dened operating
temperature range of 0°C to +50 °C, e.g. because it was stored in a cool or hot place,
put the audio processor in a place with room temperature (typ. +20 °C to +25 °C) and
wait at least 30 minutes before you switch on the audio processor. This ensures that
the audio processor is not operated outside its dened operating temperature range.
Fig. 2 The SONNET 2 audio processor in OFF position Fig. 3 The SONNET 2 audio processor in ON position
After switching on the audio processor, the indicator light will blink green up to four
times indicating the activated programme. For example, if the light blinks three times,
then programme 3 is currently active. The audio processor begins working as soon as
the green light comes on and blinks.

SONNET 2 audioprocessor
16
When the user is a young child, the battery pack cover lock must always be
turned clockwise into the locked position (see Fig. 6) once the cover has been
moved completely over the frame to prevent the child from disassembling the
audio processor.
To activate your CI system, switch on the audio processor, place it, i.e. control unit and
battery pack, behind the ear and the coil with the at side to the head over the site
of the implant (see Fig. 4). As soon as the coil is approximately over the implant, it is
automatically positioned correctly by attraction to the implant magnet.
An ear mould may help keep the processor in position on the ear. Contact your
CI centre or audiologist for assistance.
Fig. 4 Audio processor behind the ear and coil over the site of the implant
In the OFF position, the audio processor is turned off. No current is drawn in this
position. Make sure to pull back the battery pack cover of your audio processor when it
is not in use, as this prolongs the lifetime of the batteries (see also chapter 7, Care and
maintenance).
If the processor is not worn behind the ear and turned off, i.e. the battery pack
cover pulled back, make sure that young children do not have access to the
audio processor to prevent disassembling the device.

SONNET 2 audioprocessor
17
Telecoil
The audio processor has an integrated telephone coil (telecoil). The telecoil picks up
magnetic sound signals coming from telephone receivers or loop systems which are
installed in some public buildings and converts them into audible signals.
To use the telecoil, proceed as follows:
• Activate the telecoil by pressing the key (only signals picked up by the telecoil
will be audible) or (signals picked up by the microphone and the telecoil will be
audible) on your FineTuner as described in chapter 4, SONNET 2 audio processor,
FineTuner, FineTuner controls.
• When you are using a telephone, position the telephone so that its earpiece is
centred over the control unit. Move the telephone slightly up or down as necessary
to optimise the signal quality.
• When you are in an environment with a loop system, try to nd a spot where the
signal quality is best for you.
• To deactivate the telecoil when you do not need it anymore, press the key on
your FineTuner as described in chapter 4, SONNET 2 audio processor, FineTuner,
FineTuner controls.
When you switch on the audio processor, the microphone is active even if you had
the telecoil selected before you switched off the audio processor. When the telecoil is
active, you may hear buzzing sounds when operating a FineTuner key. The buzzing is
normal and indicates that a command is being sent. To reduce interference with various
electronic and electrical equipment when the telecoil is active, we recommend you
reduce audio sensitivity (see chapter 4, SONNET 2 audio processor, FineTuner, FineTuner
controls).

SONNET 2 audioprocessor
18
FineTuner
The FineTuner is a small remote control for the audio processor. The FineTuner is
provided to help you optimally use your audio processor in changing daily listening
situations.
If you are using the FineTuner Echo, please refer to the user manual of the FineTuner
Echo.
The audio processor itself has only an ON/OFF switch. All other functions are accessed
with the FineTuner, which transmits commands to your audio processor via a radio
frequency (RF) link. Its ergonomic design and larger size keys facilitate changing the
settings of your audio processor, just like a remote control allows you to change
channels on your television.
Keep the FineTuner out of the reach of children to prevent them from inadvertently
changing the settings of their audio processor.
The FineTuner is not necessary for the function of your audio processor. When switched
on, the audio processor activates the same programme, volume and audio sensitivity
setting it had when it was switched off.
The FineTuner is congured for its designated target audio processor, i.e. only the
target audio processor will execute the desired command when a certain key is pressed
on the FineTuner. The typical maximum operating distance between the FineTuner and
the audio processor is approximately 80 cm. This range might be less if you are close to
electronic and electrical equipment even if this equipment complies with all applicable
electromagnetic emission requirements.
How to congure your FineTuner
The FineTuner is congured for your individual audio processor and cannot be used
by another cochlear implant user. Your audiologist or clinical staff will congure the
FineTuner to suit your needs. Sometimes it may be necessary for you to synchronise
your FineTuner and audio processor (e.g. if you purchase a backup FineTuner).
To synchronize your FineTuner, proceed as follows:
1. Switch off the audio processor.
2. Place the coil on the keypad of the FineTuner (approx. over key ).
3. Switch on the audio processor.