Oticon CI-Link Manuale utente

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

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

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

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

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.

“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.

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.

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.

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

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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