oticon CI-Link Instruction 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]

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 audiolo­gists 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.

11

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.

12

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

13

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 tam­per tool. Caregivers must ensure these components are not manipulated by the patient.

14

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.

15

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 program­ming 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.

16

17

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 pro­gramming adaptors.

The programming adaptor is available in two colour codes: red/blue. These colour-coded pro­gramming adaptors match the CI-link unit red/blue colour indications (top view) to make it eas­ier 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.







20

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.

21

Disconnecting CI-Link from the PC

If you wish to power off CI-Link without switching off the PC, you can disconnect the USB cable
from the CI-Link unit or from the PC.

Note: CI-Link automatically powers off together with the PC.

22

Visual indications

The CI-Link unit is equipped with four green light indicators to easily identify the status of the
device.

"Left" and
"Right"

    Green light repeats the

following blinking sequence:
a medium light followed by two short
lights

      Green light blinks quickly

Connection established

The green light continuously repeats the same
blinking sequence when communication is being
established between the sound processor (left/
right) and CI-Link.
Conversely, when the communication between the
sound processor (left/right) and CI-Link is dis­rupted or when ending the fitting session, the light
turns off.

Communication in progress

The green light blinks quickly when CI-Link and
sound processor communicate (programming,
etc.).

"PC Com"

    Green light repeats the

following blinking sequence: a
medium light followed by two short
lights

Connection established

The green light continuously repeats the same
blinking sequence when the communication is
being established with software, and remains on
once communication is established.

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"PC Com"

      Green light blinks quickly

Communication in progress

The green light blinks whenever there is actual
communication between CI-Link and software (i.e.
firmware upgrade, communication with the sound
processor).

"Power"

Green light on

Power supply on

The green light is on whenever CI-Link is connected
and powered by the PC.

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Care and maintenance

Cleaning

We recommend regular cleaning of the CI-Link unit and accessories using a damp cloth with
water or alcohol. In particular in the operating room, it should be cleaned before each use. For
all parts in contact with the patient (i.e. programming adaptor), you can use audiological cleaning
wipes, which dissolve earwax and clean perspiration.

Warning: Do not perform servicing and maintenance while CI-Link is in use.

25

Equipment failure, service and repair

We recommend regular visual inspection of the CI-Link unit and accessories to check its condi­tion. In the case of a faulty accessory, replace the defective element. If you suspect that the
functionality or operating safety of the CI-Link unit may be faulty in any way, disconnect CI-Link
from the PC, and make sure that it cannot be used by others until it has been serviced. Contact
your local Oticon Medical customer service or Oticon Medical distributor.

Warning: Do not use a defective device or accessory.

Do not return a CI-Link until you have gone through the troubleshooting procedure and agreed
with your local Oticon Medical customer service or Oticon Medical distributor to return it. To
return, place the CI-Link unit and accessories in the original packaging material, with a detailed
description of the problem.

Warning: The CI-Link unit and accessories do not contain any elements which may be repaired by

the user or the implant centre. It is strictly forbidden to modify or open the device for any reason.
For all repairs, contact your local Oticon Medical customer service or Oticon Medical distributor
which is solely responsible for the maintenance of its products. Any attempt to open the unit and
accessories will automatically lead to cancellation of the warranty.

26

Precautions

The CI-Link unit and accessories must be handled with care.

Important: Observe the following precautions:

Temperature

Do not expose the instrument to extreme temperatures.
Do not store or use the instrument outside its normal operating temperature
range. Refer to the technical specifications listed below.

Water and liquids

CI-Link must never be washed or immersed in water or other liquids. It is impor­tant to protect it from dust, dirt and humidity.

27

Troubleshooting

You can refer to the Visual Indications section to verify correct CI-Link status.

If you experience issues while using CI-Link, you can try to identify and solve the problem by fol­lowing the steps described below. If the problem persists, contact your local Oticon Medical cus­tomer service or Oticon Medical distributor.

Problem Possible cause Solution

The “Left” and/or “Right” indi­cators light up, then turn off
after a few seconds when initiat­ing a connection to a sound pro­cessor plugged in the corre­sponding connector

CI-Link is unable to
communicate with the
sound processor

Ensure that the programming adaptor is prop­erly connected to both the CI-Link unit and the
sound processor. If the problem persists, the
sound processor or the programming adaptor
might be faulty. Try again with another sound
processor and programming adaptor before
contacting your local Oticon Medical customer
service or Oticon Medical distributor

The “PC Com” indicator does not
light up when initiating a con­nection to a sound processor

CI-Link communication
problem or self-diag­nostic error

Disconnect the CI-Link unit and then reconnect
it. Restart the software and try again. If the
problem persists, try connecting it to another
computer before contacting your local Oticon
Medical customer service or Oticon Medical
distributor

28

The “Left”, “Right” and “PC
Com” green lights blink slowly
simultaneously

Unrecoverable error in
the CI-Link unit

Disconnect and connect the CI-Link unit again.
If the problem persists, contact your local
Oticon Medical customer service or Oticon
Medical distributor

The “Power” indicator
on the interface
does not light up

USB cable connection
problem

Ensure that the USB cable is properly function­ing and connected to a USB port on the com­puter – and not to a USB hub. Check that the
interface itself has been properly connected

The “Power” indicator lights up,
then goes out after a few
seconds

USB cable connection
problem

Restart the software installation process. It may
be that the problem is due to the equipment.
Try another computer before contacting your
local Oticon Medical customer service or Oticon
Medical distributor

29

Disposal

As electronic equipment, the CI-Link unit and accessories cannot be disposed of with household
waste, but are subject to sorted waste collection. They must be delivered to an appropriate col­lection point for processing.

This process must comply with the main objective of Directive 2012/19/EU (WEEE) on the preven­tion of waste electrical and electronic devices and in addition, the re-use, recycling and other
forms of recovery of such waste.

Oticon Medical is concerned about the preservation of our environment and is a member of the
French environmental body “Récylum” for the collection and recycling of our devices. You can
send the CI-Link unit and accessories back to your local Oticon Medical customer service or Oti­con Medical distributor for recycling.

30

Risks and related instructions for use

• Make sure you always use accessories compatible with the CI-Link unit. Check the Oticon

Medical order form for availability and ordering.

• Never try to connect the CI-Link unit and accessories to devices other than those specified by

Oticon Medical. This could lead to a reduction in the overall safety level of the system or
cause permanent damage to CI-Link.

• Accidental damage (such as dropping) and incorrect handling can have a negative effect on

the functionality of the device. Contact your local Oticon Medical customer service or Oticon
Medical distributor for advice.

• CI-Link contains electronic components. As such, avoid any partial or total immersion in a liq-

uid, as this may seriously compromise personal safety. In general, avoid storing CI-Link in a
humid environment, and store it in a dry location with an ambient temperature.

• Do not use the instrument in the presence of flammable anaesthetics (gases).

• The CI-Link unit should not be used in close proximity to other radiating systems, such as

X-ray machines, MRI scanners, echography devices, equipment emitting vibrations, ultra­sounds or infrasounds, etc. The CI-Link unit and accessories should not be used adjacent to
or stacked with other equipment (except computer, sound processors).

31

• CI-Link is a non-sterile device. When using the device in an operating room, the sound proces-

sor and the antenna should not be in contact with the sterile field, and should be placed in a
sterile covering.

Warning: If you are in any doubt about the functioning of CI-Link, contact your local Oticon

Medical customer service or Oticon Medical distributor for your safety to ensure you are not
exposed to any risks.

32

Physical and performance characteristics

Essential performance Neuro Cochlear Implant System: Accuracy of the electrical stimulation

(<10% at C-level)

PC interface The serial USB (Universal Serial Bus) port is used for communication

between a PC and the CI-Link unit
Communication: USB 2.0
USB Connector Type: "Type B" connector (on the CI-Link unit)

Power supply The CI-Link unit is powered from the PC USB port.

Input Voltage: 5VDC
Maximum CI-Link consumption: 2.5 W (with load)

Power output Output Voltage: 1.2VDC up to 4VDC, or 5VDC

Maximum output power (transmitted power):
– 400mW per channel (if output voltage is between 1.2VDC and 4VDC)
– 900mW per channel (if output voltage is 5VDC)

CI-Link unit Dimensions (L x W x H): 150 x 103.5 x 30mm

Weight: 190g

Cables Programming adaptors

Maximum length of cable: 2.95m

USB cable (type A to type B)

Maximum length of cable: 1.80m

33

Output ratings Output for sound processors

These output ratings are valid for left and right
Programmable battery supply, common for left and right side: 5.0VDC,
or between 1.2VDC and 4.0VDC.

Output for third-party equipment

BNC output provides a TTL signal (5 Volts - 5mA max.)

Operating conditions Operating temperature: +5°C to +45°C

Relative humidity: 10% to 90%
Atmospheric pressure: 700 hPa to 1060 hPa

Transport and storage
conditions

Temperature: -20°C to 50°C
Relative humidity: 0% to 90%
Atmospheric pressure: 700 hPa to 1060 hPa

Classification Protection against electric shocks:

Class II ME equipment
Type B applied parts

Accessories intended to be used with the CI-Link programming system:

• USB cable (181772)

• Programming adaptors (159689, 173414)

• Tamper tool (185326)

• Clip (176669)

34

Symbols

0459

CE registration mark with notified body number. Indicates compliance with the requirements of
the Active Implantable Medical Device Directive 90/385/EEC.

Warning.

Consult the operating instructions.

www.oticonmedical.com

Consult the electronic operating instructions (eIFU) available at www.oticonmedical.com

Serial number.

Reference.

Batch code.

Date of manufacture.

Manufacturer.

Affected by dampness – store in a dry place.

Type B device. Device for which the parts applied and connected to the user are not conductive.

Refer to instruction manual.

35

-20°C

+50°C

Temperature limits to which the medical device can be exposed.

Humidity limits to which the medical device can be exposed.

Atmospheric pressure limits to which the medical device can be exposed.

The electrical device must be disposed of in a separated waste collection. Directive for recycling
electrical and electronic equipment (waste electrical and electronic equipment (WEEE)).

5V – 500mA

Input voltage

Class II electrical device with double insulation.

10%

90%

700
hPa

1060
hPa

36

Profile of the person handling CI-Link

The professional is the operator when he:

• Connects CI-Link to the PC

• Connects CI-Link to a programmable sound processor

• Performs fittings and objective measurements with the sound processor, through CI-Link and

Genie Medical CI fitting software

• Connects and disconnects the accessories

37

Manufacturer's declaration

Medical electrical equipment requires special precautions to be taken for EMC (Electromagnetic
Compatibility) and it is necessary to install and start it according to the EMC information pro­vided in the tables below. Portable RF (radio frequency) communication devices, such as mobile
telephones, may affect the operation of CI-Link. Therefore, these devices should be kept as far
away as possible from the CI-Link unit and accessories in order to avoid such effects.

Guidelines and manufacturer's declaration – Electromagnetic emissions

CI-Link is intended for use in the electromagnetic environment specified below. The CI-Link user should
ensure that it is used in such an environment.

Emissions tests Compliance

CISPR 11 RF emissions Group 1

CISPR 11 RF emissions Class A

Harmonic emissions
IEC 61000-3-2

Not applicable

Voltage fluctuations and flicker emissions
IEC 61000-3-3

Not applicable

38

Guidelines and manufacturer's declaration – Electromagnetic immunity

CI-Link is intended for use in the electromagnetic environment specified below. The CI-Link user should
ensure that it is used in such an environment.

Immunity test Test level IEC 60601 Level of compliance

Electrostatic discharge (ESD)
IEC 61000-4-2

±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air

± 8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air

Radiated RF
IEC 61000-4-3

±10 V/m from 80 MHz to 2.7GHz
80% AM at 1kHz

±10 V/m from 80 MHz to 2.7GHz
80% AM at 1kHz

Power frequency (50/60 Hertz)
magnetic field
IEC 61000-4-8

30 A/m
(50/60 hertz)

30 A/m
(50/60 hertz)

Warning: CI-Link is intended for use by healthcare professionals only. It may cause radio

interference or disrupt the operation of nearby equipment. It may be necessary to take
mitigating actions, such as re-orienting or relocating CI-Link or shielding the location.

Note: UT is the A.C. mains voltage prior to application of the test level.

39

Test

frequency

(MHz)

Band

(MHz)

Service Modulation

Maximum

power (W)

Distance (m)

IMMUNITY

TEST LEVEL

(V/m)

385 380 – 390 TETRA 400

Pulse

modulation

18 Hz

1,8 0,3 27

450 430 – 470

GMRS 460,

FRS 460

FM ± 5 kHz

deviation

1 kHz

deviation

2 0,3 28

710

704 – 787 LTE Band 13, 17

Pulse

modulation

217 Hz

0,2 0,3 9745

780

810

800 – 960

GSM 800/900,

TETRA 800,

IDEN 820,

CDMA 850,

LTE Band 5

Pulse

modulation

18 Hz

2 0,3 28

870

930

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment

40

Test

frequency

(MHz)

Band

(MHz)

Service Modulation

Maximum

power (W)

Distance (m)

IMMUNITY

TEST LEVEL

(V/m)

1720

1700 – 1990

GSM 1800;

CDMA 1900;

GSM 1900;

DECT; LTE

Band 1, 3, 4,

25; UMTS

Pulse

modulation

217 Hz

2 0,3 28

1845

1970

2450 2400 – 2570

Bluetooth,

WLAN, 802,11

b/g/n, RFID

2450, LTE

Band 7

Pulse

modulation

217 Hz

2 0,3 28

5240

5100 – 5800

WLAN 802,

11 a/n

Pulse

modulation

217 Hz

0,2 0,3 95500

5785

41

Date of last review: 2018-05

42

Notes

43

Notes

www.oticonmedical.com

196840UK - version A

Oticon Medical

NEURELEC

2720 Chemin Saint-Bernard

06220 Vallauris

France

TEL: [phone]
FAX: [phone]
[e-mail]