oticon CI-Link Manual de usuario
Neuro – The Cochlear Implant System
CI-Link Programming System
Instructions for Use
0459
(2018)
NEURELEC
2720 Chemin Saint-Bernard, 06220 Vallauris – France
TEL: +33 (0)4 93 95 18 18, FAX: +33 (0)4 93 95 38 01
2
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
3
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
4
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
5
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.
6
“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.
7
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.
8
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.
9
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
10
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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