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Advanced Bionics CI-6101, Instructions For Use Manual

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80

:םהלש תויועמשמהו תויוות לע םילמס

 שומישל רושיא .יפוריאה דוחיאה לש תומיאת ןמיס

2013 תנשב CE ןמיסב

םגד רפסמ

רוציי ךיראת

ירודיס רפסמ

ןרצי

B :הנגה גוס 

 ןיב ןוסחא תרוטרפמט

 +55˚C-ל  -20˚C

ריבש

ביטרהל ןיא

הנמ רפסמ

שומיש תוארוה ואר 

 ,106kPa-ל 70kPa ןיב ירפסומטא ץחלל םיאתמ

 םיה ינפ הבוג לעמ 'מ 3,000-ל ךרע הווש אוהש

.םיה ינפ הבוגל תחתמ 'מ 380 דעו

0-95% ןיב תיסחי תוחלל הפישחל םיאתמ

 תויצראהו תוימוקמה תונקתל םאתהב וכילשה

תומיאתמה

 הזה גורידה .IP20 אוה CPI-3 לש גורידה

 וא םימ לש הרידח דגנ ןגומ וניא CPI-3-ש ןייצמ

.םיקיקלח

XXXX-XX-XX

0

95

Summary of Contents for CI-6101

Page 1: ...s for use 2013 Manufactured by Advanced Bionics LLC California U S A 1 661 362 1400 AdvancedBionics com Advanced Bionics AG Laubisr tistrasse 28 8712 St fa Switzerland 41 58 928 78 00 029 M512 89 Engl...

Page 2: ...onnected to a computer running SoundWave Professional Suite software and a sound processor s Programming Kits CPI 3 and its accessories are available as part of programming kits and also as separate i...

Page 3: ...ion Kit Qty CI 6101 CPI 3 1 CI 6407 Harmony Auria Programming Cable 2 CI 6406 PSP Programming Cable 1 CI 6405 Na da CI Programming Cable 2 CI 6515 Neptune Programming Cable 2 CI 6408 002 USB Cable 2m...

Page 4: ...1 Start SoundWave software version 2 2 or later on your computer 2 Connect the CPI 3 to a USB port on your PC using the supplied USB cable 3 Connect the sound processor s to the CPI 3 using the progra...

Page 5: ...4 Programming Connections f CI Patient USB Cable Programming Cables...

Page 6: ...Front view Back view Figure 1 Front back views of the CPI 3 Functionality not available with current software release CPI 3 power indicator Sound processor indicator Trigger Audio USB Serial Number M...

Page 7: ...Clinical Programming Interface CPI 3 Provides a bridge between the computer s USB port and the sound processor Additionally the CPI 3 delivers power from the computer s USB port to the connected soun...

Page 8: ...mming cable Programming Cable Processor specific programming cables are used to connect processors to the CPI 3 A lock is available to help secure the programming cable to the PSP It slides onto the s...

Page 9: ...her headpiece cable is plugged into the sound processor and the headpiece is locked with the implant The corre sponding Sound Processor indicator light on the front of the CPI 3 will start to flash gr...

Page 10: ...PI 3 directly on the table the unit may also be placed in a wearing clip and attached to a patient s clothing or worn around the patient s neck using a lanyard Minimum Hardware and Software Requiremen...

Page 11: ...ive Symptom Troubleshooting Steps Blue LED light is off 1 Check the connection of the USB cable to the computer 2 Make sure the USB cable is correctly connected to the CPI 3 If the cable is connected...

Page 12: ...ing the Neptune program ming cable make sure that the programming header portion is fully seated on the Neptune sound processor 4 If using the PSP programming cable make sure that the pins are fully i...

Page 13: ...s to the CPI 3 may cause damage to those devices and to the CPI 3 Care must be taken as cables may pose a strangulation hazard especially in young children Clinician should inform the patient that the...

Page 14: ...refore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The CPI 3 is designed and suitable for use in clinical en...

Page 15: ...rge ESD a IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at leas...

Page 16: ...agnetic site survey b should be less than the compliance level in each frequency range c Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3...

Page 17: ...disturbances are controlled The customer or the user of the CPI 3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipme...

Page 18: ...ion from structures objects and people Compatibility Tables Table 1 Implant Type Processor Type C1 CII HiRes 90K HiRes 90K Advantage Na da CI Q90 6 6 6 Na da CI Q70 5 5 5 Na da CI Q30 6 6 6 Neptune 1...

Page 19: ...in2000 SoundWave 1 6 or earlier SoundWave 2 0 1 SoundWave 2 1 1 SoundWave 2 2 1 SoundWave 2 3 1 1 Only on Harmony Table 3 Headpiece Type Processor Type Universal Head piece Aqua Mic Auria Head piece P...

Page 20: ...mmerse Do not attempt to service or modify the Naida CI or its accessories Doing so may compromise system performance and will void the manufacturer s warranty Products should be serviced only at Adva...

Page 21: ...ragile Do not get wet Lot Number See Instructions for Use Suitable for atmospheric range between 70kPa and106kPa which is equivalent to 3000m above sea level to 380m below sea level Suitable for expos...

Page 22: ...ct e un ordinateur quip du logiciel SoundWave Professional Suite et d un ou plusieurs processeur s de son Kits de programmation L interface de programmation CPI 3 et ses accessoires sont disponibles d...

Page 23: ...erface de programmation CPI 3 1 CI 6407 C ble de programmation Harmony Auria 2 CI 6406 C ble de programmation PSP 1 CI 6405 C ble de programmation pour Na da CI 2 CI 6515 C ble de programmation Neptun...

Page 24: ...oundWave version 2 2 ou version ult rieure sur votre ordinateur 2 Connectez l interface de programmation CPI 3 un port USB de votre PC l aide du c ble USB fourni 3 Connectez le s processeur s de son l...

Page 25: ...24 Raccords de programmation f Patient CI C ble USB C bles de programmation...

Page 26: ...ant et arri re de l interface de programmation CPI 3 Fonctionnalit non disponible avec la version actuelle du logiciel T moin de charge de l interface de programmation CPI 3 T moin des processeurs de...

Page 27: ...inical Programming Interface CPI 3 Interface de programmation du clinicien CPI Fournit une passerelle entre le port USB de l ordinateur et le processeur de son L interface de programmation CPI 3 gr ce...

Page 28: ...es c bles de programmation sp cifiques au processeur sont utilis s pour connecter les processeurs l interface de programmation CPI 3 Un syst me de sabot est disponible pour stabiliser le c ble de prog...

Page 29: ...est connect au syst me lorsque son cordon d antenne est branch dans le processeur de son et que l antenne est en place sur l implant Le voyant lumineux du processeur de son correspondant l avant de l...

Page 30: ...pos e directement sur la table ou encore sur une pince attach e aux v tements du patient ou sur une lani re plac e autour du cou du patient Configuration minimum requise mat riel et logiciel Exigences...

Page 31: ...pes de d pannage Le voyant LED bleu est teint 1 V rifiez que le c ble USB est bien connect l ordinateur 2 Assurez vous que le c ble USB est bien connect l interface de programmation CPI 3 Si le c ble...

Page 32: ...le c ble de programmation Neptune assurez vous que le sabot de programmation est bien ins r sur le processeur de son Neptune 4 Si vous utilisez le c ble de programmation PSP assurez vous que les broch...

Page 33: ...seurs de son AB l interface de programmation CPI 3 Connecter d autres appareils l interface de programmation CPI 3 peut endommager ces appareils ainsi que l interface de programmation CPI 3 Les c bles...

Page 34: ...e ce fait les missions RF sont tr s faibles et ne sont pas susceptibles de provoquer d interf rences avec des appareils lectroniques proximit missions RF CISPR 11 Classe B L interface de programmation...

Page 35: ...a CEI 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Les planchers doivent tre en bois b ton ou carrelage c ramique Si le plancher est recouvert d un mat riau synth tique l humidit relative doi...

Page 36: ...agn tique sur le terrainb doit tre inf rieure au niveau de conformit pour chaque bande passantec Des interf rences peuvent se produire proximit d appareils portant le symbole suivant RF mises CEI 6100...

Page 37: ...t destin e tre utilis e dans un environnement lectromagn tique o les perturbations RF rayonn es sont contr l es Le client ou l utilisateur de l interface de programmation CPI 3 peut viter les interf r...

Page 38: ...de compatibilit Tableau 1 Type d implant Type de processeur C1 CII HiRes 90K HiRes 90K Advantage Na da CI Q90 6 6 6 Na da CI Q70 5 5 5 Na da CI Q30 6 6 6 Neptune 1 1 1 Harmony 2 3 3 1 Auria 3 3 1 Proc...

Page 39: ...SoundWave 1 6 ou version ant rieure SoundWave 2 0 1 SoundWave 2 1 1 SoundWave 2 2 1 SoundWave 2 3 1 1 Seulement avec Harmony Tableau 3 Type d antenne Type de processeur Antenne universelle Aqua Mic A...

Page 40: ...l appareil ne tentez pas de r parer ou de modifier le processeur de son Na da CI ou ses accessoires Cela pourrait compromettre les performances du syst me et rendrait la garantie du fabricant caduque...

Page 41: ...Consulter les instructions d utilisation Peut tre utilis une pression atmosph rique comprise entre 70 kPa et 106 kPa soit entre 3 000 m au dessus du niveau de la mer et 380 m au dessous du niveau de...

Page 42: ...ramming Interface CPI 3 erforderlich die das Softwareprogramm SoundWave Professional Suite mit dem den Soundprozessor en verbindet Programmier Sets CPI 3 und das passende Zubeh r k nnen in praktischen...

Page 43: ...schreibung Set Menge CI 6101 CPI 3 1 CI 6407 Harmony Auria Programmierkabel 2 CI 6406 PSP Programmierkabel 1 CI 6405 Na da CI Programmierkabel 2 CI 6515 Neptune Programmierkabel 2 CI 6408 002 USB Kabe...

Page 44: ...g 1 Starten Sie SoundWave Version 2 2 oder neuer auf Ihrem PC 2 Schlie en Sie die CPI 3 mithilfe des gelieferten USB Kabels an einen USB Anschluss Ihres PCs an 3 Schlie en Sie den die Soundprozessor e...

Page 45: ...44 Programmierverbindungen f CI Patient USB Kabel Programmierkabel...

Page 46: ...deransicht R ckansicht Abbildung 1 Vorder und R ckansicht der CPI 3 Funktion nicht mit der aktuellen Software Version verf gbar CPI 3 POWER Anzeige Soundprozessor Anzeige Trigger Audio USB Serien Numm...

Page 47: ...al Programming Interface CPI 3 Programmierschnittstelle die eine Br cke zwischen dem USB Anschluss und dem Soundprozessor darstellt Dar ber hinaus versorgt die CPI 3 den Soundprozessor w hrend der Anp...

Page 48: ...Programmierkabel Prozessorspezifische Programmierkabel werden verwendet um den Prozessor an eine CPI 3 anzuschlie en Das Programmierkabel kann mithilfe der Arretierung am PSP gesichert werden Diese w...

Page 49: ...heit angeschlossen wird Der Patient ist mit dem System verbunden sobald sein bertr gerkabel am Soundprozessor angeschlossen und der bertr ger am Implantat befestigt ist Auf der Vorderseite der CPI 3 b...

Page 50: ...m Trageclip befestigt an der Kleidung des Patienten oder mit der Trageschlaufe am Hals getragen werden Hardware und Software Mindestanforderungen Betriebssystem Windows 7 Windows 8 Windows Vista und W...

Page 51: ...bungsma nahmen Blaue LED leuchtet nicht 1 berpr fen Sie den Anschluss des USB Kabels am PC 2 Stellen Sie sicher dass das USB Kabel richtig an der CPI 3 angeschlossen ist Wenn das Kabel korrekt angesch...

Page 52: ...llen Sie sicher dass der Programmier stecker richtig mit dem Neptune Soundprozessor verbunden ist 4 Wenn Sie das PSP Program mierkabel verwenden stellen Sie sicher dass die Stifte vollst ndig eingeste...

Page 53: ...Anschluss anderer Ger te kann zu Sch den an diesen und der CPI 3 f hren Seien Sie bei der Verwendung der Kabel vorsichtig da sie eine Strangulationsgefahr darstellen Der Arzt hat den Patienten darauf...

Page 54: ...nd die Hochfrequenz Emissionen sehr niedrig und d rften zu keiner Interferenz mit benachbarten Ger ten f hren HF Emissionen CISPR 11 Klasse B Die CPI 3 ist f r den Gebrauch in klinischer Umgebung konz...

Page 55: ...4 2 6 kV Kontakt 8 kV Luft 6 kV Kontakt 8 kV Luft Der Bodenbelag sollte aus Holz Beton oder Keramikfliesen bestehen Wenn die Bodenbel ge aus synthetischen Materialien bestehen muss die relative Luftf...

Page 56: ...c St rungen k nnen in der N he von Ger ten mit dem folgenden Symbol auftreten HF Strahlung IEC 61000 4 3 3 V m 80 MHz bis 2 5 GHz 3 3 V m Hinweis 1 Es ist m glich dass diese Spezifikationen nicht f r...

Page 57: ...3 k nnen elektromagnetische Interferenzen vermeiden indem sie zwischen dem tragbaren und mobilen HF Kommunikationsger t Sender und der CPI 3 den unten empfohlenen Mindestabstand einhalten Dieser Mind...

Page 58: ...tabellen Tabelle 1 Implantattyp Prozessortyp C1 CII HiRes 90K HiRes 90K Advantage Na da CI Q90 6 6 6 Na da CI Q70 5 5 5 Na da CI Q30 6 6 6 Neptune 1 1 1 Harmony 2 3 3 1 Auria 3 3 1 Platinum Soundproze...

Page 59: ...Wave 1 6 oder ltere Version SoundWave 2 0 1 SoundWave 2 1 1 SoundWave 2 2 1 SoundWave 2 3 1 1 Nur auf Harmony Tabelle 3 bertr gertyp Prozessortyp Univer sal ber tr ger Aqua Mic Auria bertr ger Platinu...

Page 60: ...nicht das Na da CI oder sein Zubeh r selbst zu reparieren oder zu modifizieren Dadurch k nnen Sie das System besch digen und die Herstellergarantie ung ltig machen Jegliche Reparaturleistung darf nur...

Page 61: ...Lot Nummer Siehe Gebrauchsanweisung Geeignet f r atmosph rischen Bereich zwischen 70 kPa und 106 kPa bis 3000 m ber dem Meeresspiegel und 380 m unter dem Meeresspiegel Geeignet f r relative Luftfeucht...

Page 62: ...61 CPI 3 CPI 3 SoundWave Professional Suite CPI 3 CI 6017 CI 6101 CPI 3 1 CI 6407 Harmony Auria 1 CI 6406 PSP 1 CI 6405 Na da CI 1 CI 6515 Neptune 1 CI 6408 002 2 USB 1...

Page 63: ...62 CI 6201 1 CI 6202 1 CI 6018 CI 6101 CPI 3 1 CI 6407 Auria Harmony 2 CI 6406 PSP 1 CI 6405 Na da CI 2 CI 6515 Neptune 2 CI 6408 002 2 USB 1 CI 6201 1 CI 6202 1 1...

Page 64: ...63 CI 6203 CPI 3 CI 6408 003 3 USB AB 653X X 1 1 2 2 SoundWave 2 2 USB CPI 3 USB 3 3 CPI 3 4 4 CPI 3...

Page 65: ...64 f CI USB...

Page 66: ...65 CPI 3 CPI 3 1 CPI 3 USB...

Page 67: ...66 Micro USB CPI 3 2 USB CPI 3 CPI 3 USB 2 2 SoundWave SoundWave SoundWave...

Page 68: ...67 CPI 3 USB USB micro USB USB CPI 3 USB CPI 3 USB CPI 3 CPI 3 PSP Auria Harmony CPI 3 1 1 SoundWave 2 2 CPI 3 micro USB USB 1 USB 2 CPI 3 USB Advanced Bionics USB 1 USB...

Page 69: ...68 1 CPI 3 CPI 3 3 3 CPI 3 micro HDMI 2 CPI 3 PowerCel CPI 3 CPI 3 2 PSP PSP...

Page 70: ...69 3 USB CPI 3 Windows 8 Windows 7 Windows XP Home Windows Vista Windows XP Professional SP3 SP3 USB USB 1 1 SoundWave...

Page 71: ...70 CPI 3 AB 1 1 USB 2 2 USB CPI 3 3 3 AB USB 4 4 USB 5 5 USB 6 6 AB USB...

Page 72: ...71 1 1 CPI 3 2 2 Auria Harmony 3 3 Neptune Neptune 4 4 PSP PSP CPI 3 1 1 2 2 SoundWave 3 3 SoundWave...

Page 73: ...72 CPI 3 USB CPI 3 CPI 3 CPI 3 CPI 3 AB CPI 3 CPI 3 CPI 3 USB IEC 60950...

Page 74: ...73 IEC 60601 1 2 RF CISPR 11 1 CPI 3 RF RF RF CISPR 11 Class B CPI 3 USB IEC 61000 3 2 IEC 61000 3 3...

Page 75: ...74 CPI 3 CPI 3 IEC 60601 ESD IEC 61000 4 2 6 kV 8 kV 6 kV 8 kV 30 50 60 Hz IEC 61000 4 8 3 A m 3 A m...

Page 76: ...75 RF CPI 3 d 1 2 P 800 MHz d 2 3 P 800 MHz P d W RF RF IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m 1 FM AM RF...

Page 77: ...76 CPI 3 RF CPI 3 80 MHz 150 kHz 3 V m CPI 3 RF CPI 3 CPI 3 RF RF CPI 3 W d 1 2 P MHz 800 d 2 3 P MHz 800 0 01 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 8 7 3 100 12 23 d P W...

Page 78: ...dvantage Na da CI Q90 6 6 6 Na da CI Q70 5 5 5 Na da CI Q30 6 6 6 Neptune 1 1 1 Harmony 2 3 3 1 Auria 3 3 1 PSP Platinum 4 1 SoundWave 2 1 1 SoundWave 2 0 2 SoundWave 1 4 3 CPI II SClin2000 4 CPI 3 So...

Page 79: ...1 CII HiRes 90K HiRes 90K Advantage SClin2000 SoundWave 1 6 SoundWave 2 0 1 SoundWave 2 1 1 SoundWave 2 2 1 SoundWave 2 3 1 Harmony 1 3 AquaMic Auria Platinum Na da CI 1 Neptune Harmony Auria PSP Aqua...

Page 80: ...79 4 C1 CII HiRes 90K HiRes 90K Advantage CPI II CPI 3 1 Harmony 1 Na da CI Advanced Bionics 15 C 59 F 30 C 86 F 95 3 000 380...

Page 81: ...80 2013 CE B 55 C 20 C 106kPa 70kPa 3 000 380 0 95 IP20 CPI 3 CPI 3 XXXX XX XX 0 95...

Page 82: ...face CPI 3 collegata ad un computer dotato del software SoundWave Professional Suite e di almeno un processore sonoro Kit di programmazione La CPI 3 e i relativi accessori sono forniti all interno di...

Page 83: ...izione Quantit Kit CI 6101 CPI 3 1 CI 6407 Cavo di programmazione Harmony e Auria 2 CI 6406 Cavo di programmazione PSP 1 CI 6405 Cavo di programmazione Na da CI 2 CI 6515 Cavo di programmazione Neptun...

Page 84: ...rsione 2 2 o successive sul computer 2 Collegare la CPI 3 a una porta USB sul computer tramite il cavo USB fornito in dotazione 3 Collegare il i processore i sonoro i alla CPI 3 tramite il i cavo i di...

Page 85: ...84 Collegamenti di programmazione f Paziente CI Cavo USB Cavi di programmazione...

Page 86: ...Vista posteriore Figura 1 Vista anteriore e posteriore della CPI 3 Funzionalit non disponibile con l attuale versione software Spia di accensione della CPI 3 Spia del processore sonoro Attivatore Aud...

Page 87: ...seguenti strumenti Interfaccia di programmazione clinica CPI 3 Costituisce un ponte fra la porta USB del computer e il processore sonoro Inoltre tramite la porta USB del computer la CPI 3 alimenta il...

Page 88: ...rogrammazione Per collegare i processori alla CPI 3 devono essere usati cavi di programmazione specifici per quei processori disponibile anche un blocco di sicurezza per fissare meglio il cavo di prog...

Page 89: ...ndo il cavo della sua antennina attaccato al processore sonoro e l antennina fissata all impianto La relativa spia luminosa del processore sonoro posta sulla parte frontale della CPI 3 comincia a lamp...

Page 90: ...pu essere posizionata direttamente sul tavolo oppure inserita in una clip e attaccata agli abiti del paziente o indossata intorno al collo tramite l apposito girocollo Requisiti minimi hardware e sof...

Page 91: ...cnica AB locale Sintomo Procedura Il LED blu spento 1 Verificare il collegamento del cavo USB al computer 2 Verificare che il cavo USB sia collegato correttamente alla CPI 3 Se il cavo collegato corre...

Page 92: ...rificare che la parte della testina di programmazione sia completamente posizionata sul processore sonoro Neptune 4 Se si usa il cavo di programmazione PSP verificare che i pin siano completamente ins...

Page 93: ...sare danni sia a tali dispositivi che alla CPI 3 Occorre prestare attenzione in quanto i cavi possono comportare un rischio di strangolamento soprattutto nel caso dei bambini piccoli Il medico deve sp...

Page 94: ...oni RF sono molto basse ed improbabile che causino interferenze nelle apparecchiature elettroniche situate nelle vicinanze Emissioni RF CISPR11 Classe B La CPI 3 stata progettata ed idonea per essere...

Page 95: ...kV aria 6 kV contatto 8 kV aria I pavimenti devono essere fatti di legno calcestruzzo o piastrelle di ceramica Se i pavimenti sono rivestiti di materiale sintetico l umidit relativa deve essere almeno...

Page 96: ...to al livello di conformit in ciascun range di frequenza c L interferenza pu verificarsi nelle vicinanze di apparecchiature contrassegnate con il simbolo seguente RF irra diata IEC 61000 4 3 da 3 V m...

Page 97: ...elettromagnetico in cui vengono controllati i disturbi RF irradiati Il cliente o l utente della CPI 3 pu aiutare a evitare l interferenza elettromagnetica mantenendo una distanza minima tra l apparecc...

Page 98: ...trutture degli oggetti e delle persone Tabelle di compatibilit Tabella 1 Tipo di impianto Tipo di processore C1 CII HiRes 90K HiRes 90K Advantage Na da CI Q90 6 6 6 Na da CI Q70 5 5 5 Na da CI Q30 6 6...

Page 99: ...oundWave 1 6 o versioni precedenti SoundWave 2 0 1 SoundWave 2 1 1 SoundWave 2 2 1 SoundWave 2 3 1 1 Solo su Harmony Tabella 3 Tipo di antennina Tipo di processore Anten nina uni versale Aqua Mic Ante...

Page 100: ...odificare il Na da CI o i suoi accessori si rischierebbe di pregiudicare il rendimento del sistema e di annullare la validit della garanzia del costruttore I prodotti devono essere riparati soltanto p...

Page 101: ...utto Numero del lotto di produzione Vedere le istruzioni per l uso Tollera un range di pressione atmosferica compreso fra 70kPa e 106kPa che equi vale ad un altitudine compresa fra 3000 m sul livello...

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