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oticon CI-Link, Instructions For Use Manual

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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.

Summary of Contents for CI-Link

Page 1: ...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...

Page 2: ...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 1...

Page 3: ...ocessor 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 Troubleshoo...

Page 4: ...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...

Page 5: ...nd 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 als...

Page 6: ...uipment 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...

Page 7: ...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...

Page 8: ...SB 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 programm...

Page 9: ...ght 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...

Page 10: ...tput 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 60...

Page 11: ...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...

Page 12: ...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 u...

Page 13: ...omer 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 d...

Page 14: ...nt 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...

Page 15: ...y 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 ca...

Page 16: ...ssor 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 s...

Page 17: ...e 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 tam...

Page 18: ...tors 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...

Page 19: ...nectors 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...

Page 20: ...d 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 ha...

Page 21: ...ng 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 togethe...

Page 22: ...ound processor left right and CI Link Conversely when the communication between the sound processor left right and CI Link is dis rupted or when ending the fitting session the light turns off Communic...

Page 23: ...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 l...

Page 24: ...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...

Page 25: ...n 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...

Page 26: ...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 liqu...

Page 27: ...nicate with the sound processor Ensure that the programming adaptor is prop erly connected to both the CI Link unit and the sound processor If the problem persists the sound processor or the programmi...

Page 28: ...ht up USB cable connection problem Ensure that the USB cable is properly function ing and connected to a USB port on the com puter and not to a USB hub Check that the interface itself has been properl...

Page 29: ...irective 2012 19 EU WEEE on the preven tion 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...

Page 30: ...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 comprom...

Page 31: ...e 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...

Page 32: ...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 Max...

Page 33: ...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 At...

Page 34: ...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 M...

Page 35: ...eric 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 wa...

Page 36: ...he 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 Medica...

Page 37: ...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...

Page 38: ...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...

Page 39: ...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 9 745 780 810 800 960 GSM 800 900 TETRA 800 IDEN 820 CDM...

Page 40: ...VEL 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 modulati...

Page 41: ...41 Date of last review 2018 05...

Page 42: ...42 Notes...

Page 43: ...43 Notes...

Page 44: ...www oticonmedical com 196840UK version A Oticon Medical NEURELEC 2720 Chemin Saint Bernard 06220 Vallauris France TEL 33 0 4 93 95 18 18 FAX 33 0 4 93 95 38 01 info oticonmedical com...

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