oticon CI-Link User manual

Neuro – The Cochlear Implant System
CI-Link Programming System
Instructions for Use
0459
(2018)
NEURELEC
2720 Chemin Saint-Bernard, 06220 Vallauris – France
TEL: [phone], FAX: [phone]

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Table of Content
Introduction ..................................................................................................................5
Intended use...................................................................................................................7
Compatibility ..................................................................................................................7
Description of CI-Link.................................................................................................... 8
CI-Link overview..............................................................................................................8
CI-Link unit front view......................................................................................................9
CI-Link unit rear view..................................................................................................... 10
Packaging content........................................................................................................ 12
CI-Link Fitting Room Kit ..................................................................................................12
CI-Link Operating Room Kit (Zti)......................................................................................13
When receiving CI-Link ................................................................................................ 14
Unpacking and inspection............................................................................................. 14
Storage ........................................................................................................................ 14
Preparing CI-Link for use .............................................................................................. 15
Installation ....................................................................................................................15
Connecting the programming adaptor to the sound processor........................................ 16

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Locking and unlocking the programming adaptor............................................................17
Connecting two sound processors ................................................................................. 18
Wearing the sound processor on clothes ....................................................................... 19
Using CI-Link............................................................................................................... 20
Disconnecting CI-Link from the PC ..................................................................................21
Visual indications........................................................................................................ 22
Care and maintenance................................................................................................. 24
Cleaning .......................................................................................................................24
Equipment failure, service and repair ............................................................................ 25
Precautions................................................................................................................. 26
Troubleshooting...........................................................................................................27
Disposal ..................................................................................................................... 29
Risks and related instructions for use.......................................................................... 30
Physical and performance characteristics .................................................................... 32

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Symbols...................................................................................................................... 34
Profile of the person handling CI-Link.......................................................................... 36
Manufacturer's declaration...........................................................................................37
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment ..........................................................................................39

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Introduction
The CI-Link programming system (also named CI-Link) consists of the CI-Link unit, Genie Medical
CI fitting software, and accessories.
The CI-Link programming system allows you as an audiologist or a clinical support, to make the
necessary adjustments to sound processors connected to the CI-Link unit.
• Audiologist: healthcare professional with at least 3 years of studies in audiology, with
specialized training in the usage of the device
• Clinical support: Oticon Medical personnel, who is either speech therapist, audiologist or
engineer (master’s degree), expert and trainer of the device
This manual is your guide to installing and using CI-Link. We strongly recommend that you read
this manual carefully before using CI-Link for the first time. Prior to use, we also advise you to
consult the following documentation:
• Genie Medical CI fitting software Installation guide, and Fitting guide
• Neuro 2 sound processor Instructions for use
Note: The Genie Medical CI fitting guide is available on the Oticon Medical website and embed-
ded in the Help menu of the Genie Medical CI fitting software. Contact your local Oticon Medical
customer service or Oticon Medical distributor to ask for a paper version to be sent to your
address within 7 days at no additional cost.
Note: The patient should be continuously monitored when using the device.

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“Note”: indicating a note/tip
“Important”: indicating important information which should be followed by the user,
to prevent damaging the equipment.
“Warning”: indicating an immediate danger, potential safety hazard.
Action required.
Oticon Medical ( NEURELEC) reserves the right to make changes to the design, characteristics
and models without prior notice. The only warranty Oticon Medical ( NEURELEC) makes, is the
express written warranty extended on the sale or rental of its products.

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Intended use
The CI-Link programming system is intended, in a healthcare facility, to allow trained audiolo-
gists and clinical supports to:
• Fit the cochlear implant system
• Perform objective measures, including impedance measurement and ECAP (ECAP available
with Neuro Zti implants only).
Compatibility
The CI-Link programming system is compatible with the Neuro Zti cochlear implants and Neuro 2
sound processors.
Note: If you require assistance in setting up, using or maintaining CI-Link please
contact your local Oticon Medical customer service or Oticon Medical distributor.
Warning: Never try to connect CI-Link with elements other than those provided.
Warning: Do not use or connect a sound processor or accessories other than those specified
as being compatible with the CI-Link programming system.

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Description of CI-Link
CI-Link overview
PC (USB 2.0 port)
with Genie Medical CI
fitting software
Neuro 2 sound processor(s)
(without battery module)
CI-Link unit
Programming
adaptor left (blue) USB cable
Programming
adaptor right (red)
Note: The programming adaptors indicated above are applied parts.

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CI-Link unit front view
Blue colour code
Indication for left connection
Mini-DIN connector (left)
Connection to left sound processor
“Left” Light indicator
Communication with left sound processor
Mini-DIN connector (right)
Connection to right sound processor
“Right” Light indicator
Communication with right sound processor
“Power” Light indicator
Communication with PC
Manufacturer
Product name
Red colour code
Indication for right connection
“PC Com” Light indicator
Power supply from PC

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PC / USB connector
Connection to PC
BNC trigger output
Connection to third-party
equipment*
(reserved for later use)
CI-Link unit rear view
*The third-party equipment must be compliant with the IEC 60601-1 standard with 1MOPP isolation, or
with the IEC 60950 standard.
Pictures are not contractually binding.

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Important: We recommend not using a USB hub to connect the CI-Link unit to the PC as this
may affect power supply.
Important: PC must be compliant with the IEC 60950-1 standard.

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Packaging content
Different CI-Link packages are available. To ease identification, each package has its own marking.
CI-Link Fitting Room Kit
The CI-Link Fitting Room Kit includes the following:
• 1 CI-Link unit
• 1 USB cable (type A->B)
• 1 Instructions for use
• 2 Programming adaptors
• 2 Antenna cables
• 2 Clips

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CI-Link Operating Room Kit (Zti)
The CI-Link Operating Room Kit (Zti) includes the following:
• 1 CI-Link unit
• 1 USB cable (type A->B)
• 1 Instructions for use
• 1 Programming adaptor
• 1 Tamper tool
• 1 Neuro 2 sound processor
• 1 Antenna
• 1 Magnet
• 2 Antenna cables
• 1 USB memory stick including the Neuro 2
instructions for use in electronic format
Note: The Neuro 2 instructions for use are available on the Oticon Medical website. Contact your
local Oticon Medical customer service or Oticon Medical distributor to ask for a paper version to
be sent to your address within 7 days at no additional cost.
Note: In case of replacement, you may receive the CI-Link unit in a different package.
Note: Several antenna cable lengths are available. Check availability on the order form and
contact your local Oticon Medical customer service or Oticon Medical distributor.
Warning: The use of small parts with infants and young children create a risk of suffocation,
swallowing and ingestion hazard. These parts include: magnet, antenna, antenna cable and tam-
per tool. Caregivers must ensure these components are not manipulated by the patient.

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When receiving CI-Link
Unpacking and inspection
• Unpack CI-Link carefully.
• Keep the packaging material in the case it was delivered. If you need to return CI-Link for
servicing, the original packaging material will protect it against damage during transport.
• Visually inspect the equipment for damage. If damage has occurred, do not start using the
CI-Link unit. Contact your local Oticon Medical customer service or Oticon Medical distributor
for assistance.
• Check that the package includes the items listed above in section on Packaging content.
Storage
If CI-Link is stored, follow the guidelines below:
• Store the CI-Link unit and accessories in the packaging material provided to protect the
equipment from damage.
• Store the CI-Link unit and accessories in a clean environment.

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Preparing CI-Link for use
Installation
Before using CI-Link, make sure the Genie Medical CI fitting software has been properly
installed. For further details on software installation, refer to the Genie Medical CI Installation
guide.
Connect CI-Link to the PC, and the sound processor to its accessories (antenna, magnet, antenna
cable) as described above in the section on CI-Link overview.
Warning: Training should have been carried out prior to using CI-Link.

Connecting the programming adaptor to the sound processor
To connect the programming adaptor to the sound processor:
• If needed, deactivate the tamper-proof system with the
tamper tool
• If needed, slide the battery module off the sound processor
• Slide the programming adaptor onto the sound processor
• If needed, reactivate the tamper-proof system with the
tamper tool
Note: During the fitting session, place the battery module in a
safe place to avoid losing it.
Warning: To avoid any risk (ingestion, strangulation) during the
fitting session, especially with infants and young children, provision and usage of the program-
ming adaptor must be carried out under professional supervision.
Warning: Do not attempt to connect the programming adaptor to the battery charger as this
might damage them.
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Locking and unlocking the programming adaptor
The tamper tool secures the connection between the sound processor and the programming
adaptor to avoid any unexpected disconnection.
• To activate the tamper-proof system keeping the antenna
cable connected: Place the open side of the tamper tool on
the lock ring (1) situated around the antenna socket and turn
clockwise (2).
• To deactivate the tamper-proof system keeping the antenna
cable connected: Place the open side of the tamper tool on
the lock ring (1) situated around the antenna socket and turn
the lock ring counter clockwise (2) using the tamper tool to
deactivate.
Important: In the operating room, we strongly recommend
keeping the programming adaptor connected and locked to
the sound processor.



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Connecting two sound processors
Two sound processors can be simultaneously connected to the CI-Link unit by means of pro-
gramming adaptors.
The programming adaptor is available in two colour codes: red/blue. These colour-coded pro-
gramming adaptors match the CI-link unit red/blue colour indications (top view) to make it eas-
ier to use.
When two sound processors are to be connected, make sure you connect each sound processor
to the correct side.
When a single sound processor is to be connected, you can connect the sound processor to
either side.
Right colour code (red) to connect to
the sound processor on the right ear
Left colour code (blue) to connect to
the sound processor on the left ear

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Indeed, these programming adaptors are identical and can be exchanged if needed. The red/
blue colour code is only intended for usability.
Note: In the operating room, you can use a single programming adaptor for bilateral implanta-
tion. You just need to swap connectors on the CI-Link unit.
Wearing the sound processor on clothes
The clip accessory is designed for use with children who might get distracted by wearing
a sound processor on the ear during fitting.
To use the clip:
• Push the sound processor into the clip (1).
• Attach the clip to the patient’s clothes, near the ear (2).
To remove the clip:
• Release the clip from the patient’s clothes.
• Twist out the sound processor (3).
Note: Use a long antenna cable when wearing the clip.
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

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Using CI-Link
The CI-Link unit powers on (“Power” light indicator turns on) as soon as it is connected to the
PC, and the PC is switched on.
Once the sound processor is connected to CI-Link, during the connection process with the Genie
Medical CI fitting software, the "Left" and "Right" light indicators will successively light up. This
means the software is searching for device connection.
Once the sound processor has been detected, the corresponding “Left”/“Right” light indicator
continuously repeats the same blinking sequence (a medium light followed by two short lights).
The communication between the software and sound processor has been established.
Start the fitting session by launching the Genie Medical CI fitting software from the desktop
shortcut or the Windows programs list. Refer to the Genie Medical CI fitting guide for details on
programming the sound processors and performing objective measurements.
Warning: Do not attempt to connect or disconnect a sound processor, or cables while the sound
processor is being fitted, as this might damage it.