Johnson & Johnson Biosense Webster ThermoCool SmartTouch Скачать руководство пользователя страница 144

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Rev.: 2011-03

M-5276-692A



Biosense Webster, Inc. 2010-2011

Printed in U.S.A.

Biosense Webster, Inc.

3333 Diamond Canyon Road
Diamond Bar, CA 91765, USA
Tel: 909-839-8500
Tel: 800-729-9010
Fax: 909-468-2905
www.biosensewebster.com

European Community Representative

Biosense Webster

A Division of Johnson & Johnson Medical NV/SA
Drève Richelle 161 Building H
B-1410 Waterloo, Belgium
Tel: 32-2-352-1411
Fax: 32-2-352-1592

The T

HERMO

OOL

MART

OUCH

™

Diagnostic/Ablation Catheter and

accessories are protected under one or more of the following U.S. Patents:

5,383,923; 5,391,199; 5,443,489; 5,462,521; 5,480,422; 5,546,951; 5,558,091;

5,568,809; 5,694,945; 5,713,946; 5,718,241; 5,738,096; 6,120,476, and

6,602,242 and other patents pending in the U.S. and other countries.

IOSENSE

EBSTER

the Biosense Webster logo,

ARTO

REFACE

HERMO

OOL

and

HERMO

OOL

MART

OUCH

are trademarks of

Biosense Webster, Inc.

WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.

Содержание Biosense Webster ThermoCool SmartTouch

Страница 1: ...Norsk Side 55 60 KULLANIM TALIMATLARI T rk e Sayfa 66 71 INSTRUKCJA STOSOWANIA Polski Strona 77 N VOD K POU IT esky Strana 82 HASZN LATI TMUTAT Magyar Oldal 87 N VOD NA POU VANIE Slovensky Strana 92 N...

Страница 2: ...ate No utilice envases abiertos o estropeados N o utilizar embalagens abertas ou danificadas Geopende of beschadigde verpakkingen niet gebruiken B r ikke bruges hvis emballagen har v ret bnet eller er...

Страница 3: ...indaja Euroopa henduses P rst vis Eiropas Kopien Atstovas Europos Bendruomen je Pin Connector Connecteur broche Stiftverbinder Connettore a pin Conector de terminales Conector de pinos Pinconnector Ha...

Страница 4: ...in conjunction with a radiofrequency generator for cardiac ablation The Biosense Webster THERMOCOOL SMARTTOUCH Diagnostic Ablation Deflectable Tip Catheter provides a real time measurement of contact...

Страница 5: ...TOUCH Diagnostic Ablation Deflectable Tip Catheter should also be completed 5 The long term risks of protracted fluoroscopy and creation of RF induced lesions have not been established Careful conside...

Страница 6: ...electrode must be connected to the indifferent electrode input on the RF generator Verify that circuit impedance prior to RF ablation is within expected parameters Verify that the RF generator display...

Страница 7: ...is confirmed by a minimum of 2 C decrease in tip electrode temperature 17 Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation The peak temperature should not ex...

Страница 8: ...QUENTIAL OR OTHER DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW WITHOUT LIMITING THE FOREGOING BIOSENSE WEBSTER INC OR ITS AFFILIATED COMPANIES SHALL NOT BE LIABLE FOR ANY SPECIAL DIRECT IN...

Страница 9: ...me de navigation CARTO 3 Un dispositif de r f rence appropri est n cessaire pour positionner la r f rence de localisation Pour l utiliser dans les proc dures de cartographie et pour obtenir des infor...

Страница 10: ...c dures d ablation par cath ter sont susceptibles d entra ner une exposition importante aux rayons X ce qui peut provoquer une irradiation aigu ainsi qu un risque accru d effets somatiques et g n tiqu...

Страница 11: ...rature n augmente pas interrompre l application de l nergie et v rifier la configuration 22 Le risque d ignition de gaz inflammables ou d autres mat riaux est inh rent l lectrochirurgie Prendre des p...

Страница 12: ...eur de taille appropri e Faire progresser le cath ter jusqu la zone examiner 9 Utilisez conjointement la fluoroscopie et des lectrogrammes EGM pour aider au bon positionnement du cath ter 10 Afin d ob...

Страница 13: ...que et d c s Les complications suivantes se sont galement produites pendant des tudes pr c dentes ou ont t signal es dans la litt rature Li es au cath ter ou la proc dure de cath t risation h morragie...

Страница 14: ...TO 3 Navigationssystem bermittelt Zur Bestimmung der Referenzpositionen wird ein geeignetes Referenzger t ben tigt Hinweise zur Verwendung in Mappingverfahren sowie Informationen zu geeigneten Referen...

Страница 15: ...atheters in den Koronargef en zu vermeiden Bei der Platzierung des Ablationskatheters in den Koronargef en bei der Abgabe von HF Energie oder bei beidem wurden Myokardinfarkte beobachtet 15 Minimieren...

Страница 16: ...des Patienten f hren 19 Den Katheter nicht in der N he eines MRI Ger ts verwenden da MRI den Katheter bewegen oder erhitzen kann sodass das Bild auf dem Display verzerrt werden kann 20 Das Vorschiebe...

Страница 17: ...tor verbunden Schlie en Sie den Katheter mit einem geeigneten Biosense Webster Kabel an die PIU an Schlie en Sie die PIU mit dem geeigneten Biosense Webster Kabel an den Generator an Schlie en Sie die...

Страница 18: ...tsensor k nnte auch besch digt werden und die Messgenauigkeit beeintr chtigen Vor dem nochmaligen Einf hren sicherstellen dass die Sp l ffnungen nicht verstopft sind indem die Flussrate erh ht und der...

Страница 19: ...NERLEI BESONDERE DIREKTE BEIL UFIGE FOLGE ODER ANDERE SCH DEN DIE SICH AUS DER WIEDERVERWENDUNG VON PRODUKTEN ERGEBEN DIE F R DEN EINMALGEBRAUCH ETIKETTIERT SIND ODER DEREN WIEDERGEBRAUCH DURCH ANWEND...

Страница 20: ...ento per la localizzazione richiesto un dispositivo di riferimento appropriato Per l utilizzo in procedure di mappatura informazioni sui dispositivi di riferimento appropriati e un ulteriore descrizio...

Страница 21: ...sociata alla procedura e dopo aver preso misure precauzionali adeguate per ridurre l esposizione Deve essere prestata adeguata attenzione all uso di questo dispositivo nelle donne in gravidanza 16 Non...

Страница 22: ...r THERMOCOOL SMARTTOUCH utilizzato assieme ad un generatore RF durante il normale funzionamento potrebbe influenzare negativamente le prestazioni di altre apparecchiature 24 Elettrodi e sonde per disp...

Страница 23: ...Azzerare la lettura della forza di contatto dopo l introduzione nel paziente L elettrodo in punta e i primi due elettrodi ad anello devono trovarsi esterni all introduttore a guaina affinch il sensore...

Страница 24: ...embolia e reazioni vasovagali perforazione cardiaca versamento pericardico tamponamento trombi embolia gassosa aritmie e danni valvolari pneumotorace ed emotorace edema polmonare ipossia versamento pl...

Страница 25: ...e los dispositivos de referencia apropiados y para una mayor descripci n de la operaci n del sistema de navegaci n CARTO 3 consulte las instrucciones del sistema de navegaci n CARTO 3 Indicaciones El...

Страница 26: ...s pacientes como al personal del laboratorio La ablaci n con cat ter debe realizarse nicamente tras considerar adecuadamente la posible exposici n a la radiaci n asociada con la intervenci n y tras ha...

Страница 27: ...irigible para ablaci n y diagn stico al emplearse con un generador de RF durante una operaci n normal pueden afectar negativamente al rendimiento de otros equipos 24 Los electrodos y sondas para dispo...

Страница 28: ...nutos despu s de la conexi n al sistema CARTO 3 y 5 minutos despu s de la inserci n en el cuerpo antes de utilizar la funci n de retroalimentaci n de fuerza 11 Ponga a cero de la lectura de la fuerza...

Страница 29: ...n registrado las siguientes complicaciones durante estudios previos o se han incluido en la documentaci n especializada Relacionadas con el cateterismo intervenci n con cat ter hemorragia vascular hem...

Страница 30: ...io um dispositivo de refer ncia apropriado para fins de localiza o da posi o de refer ncia Para utilizar em procedimentos de mapeamento e para obter informa es sobre os dispositivos de refer ncia adeq...

Страница 31: ...os quer para os pacientes quer para o pessoal do laborat rio devido intensidade do feixe de raios X e dura o da imagiologia fluorosc pica A abla o por meio de cateter deve ser realizada apenas depois...

Страница 32: ...n o subir interrompa o fornecimento de energia e verifique a configura o 22 O risco de incendiar gases inflam veis ou quaisquer outros materiais inerente em electrocirurgia Devem ser tomadas as devid...

Страница 33: ...o local de entrada utilizando o tubo de inser o e uma bainha introdutora de tamanho adequado Avance o cateter at rea a ser investigada 9 Utilize a fluoroscopia e os electrogramas EGM para ajudar no co...

Страница 34: ...el Reac es adversas Foram documentadas diversas reac es adversas graves durante os procedimentos de abla o por cateter incluindo embolia pulmonar enfarte do mioc rdio AVC tamponamento card aco e morte...

Страница 35: ...iesysteem Er is een geschikt referentie apparaat nodig voor locatiereferentie doeleinden Voor gebruik in mappingprocedures en voor een uitgebreidere beschrijving van de werking van het CARTO 3 systeem...

Страница 36: ...ingreep hoort en noodzakelijke stappen zijn genomen om de blootstelling te minimaliseren Het gebruik van dit hulpmiddel bij zwangere vrouwen moet daarom zorgvuldig in overweging worden genomen 16 Stel...

Страница 37: ...tiekatheter met buigbare tip wordt geproduceerd bij gebruik in combinatie met een RF generator en tijdens normale bediening kan de prestaties van andere apparatuur nadelig be nvloeden 24 Elektroden en...

Страница 38: ...lichaam opwarmen voordat de functie voor het teruglezen van de kracht wordt gebruikt om zo een optimale nauwkeurigheid in de aflezing van de kracht en stabiliteit te bereiken 11 Stel de aflezing voor...

Страница 39: ...oeken of zijn in de literatuur vermeld Met betrekking tot katheterisatie katheteringreep vasculaire bloeding lokale hematomen trombose AV fistel pseudo aneurysma trombo embolie en vasovagale reacties...

Страница 40: ...lektrofysiologisk kortl gning stimulering og optagelse og n r det anvendes sammen med en radiofrekvensgenerator til kardiel ablation Biosense Webster THERMOCOOL SMARTTOUCH diagnosticerings ablationska...

Страница 41: ...Fors g ikke p at betjene Biosense Webster THERMOCOOL SMARTTOUCH diagnosticerings ablationskateteret med b jelig spids eller RF generatoren f r de tilh rende betjeningsvejledninger er l st helt igennem...

Страница 42: ...er stort set bestemt af hvor n jagtig temperaturspecifikationen for den anvendte RF generator er Konsulter brugerh ndbogen til den RF generator der benyttes vedr rende specifikationerne for temperatur...

Страница 43: ...skrider 30 W kan benyttes n r transmurale l sioner ikke kan opn s ved lavere energiniveauer Ved effektindstillinger 30 W anbefales en gennemstr mningshastighed p 30 ml min Temperaturen der vises p RF...

Страница 44: ...apper og forh jet fosfokinase Urelateret til enheden eller proceduren urinretention forbig ende f lelsesl shed i ekstremiteter Parkinsons syge og gastrointestinal divertikulose GARANTIFRASKRIVELSE OG...

Страница 45: ...t aiheet Biosense Webster THERMOCOOL SMARTTOUCH taivutettavak rkist diagnostista ablaatiokatetria k ytet n syd men elektrofysiologiseen kartoitukseen stimulointiin ja rekister intiin ja syd nablaatios...

Страница 46: ...euttaa ilmaemboliaa Varotoimet 1 Puhdista katetri ja huuhteluputket heparinisoidulla normaalilla keittosuolaliuoksella 2 Elektrofysiologiset katetrit ja j rjestelm t on tarkoitettu k ytett viksi ainoa...

Страница 47: ...ett asianomainen kaapeli on liitetty generaattoriin Jos l mp tilaa ei viel k n n ytet l mp tilan mittausj rjestelm ss saattaa olla virhe joka on korjattava ennen radiotaajuusvirran tuottamista 26 Bios...

Страница 48: ...irtauksen asetukset RADIOTAAJUUSVIRRAN PARAMETRISUOSITUKSET ETEISABLAATIO VENTRIKULAARINE N ABLAATIO Teho 15 W 30 W 31 W 50 W L mp tilan seuranta 50 C 50 C Huuhteluvirtaus radiotaajuusvirran tuottamis...

Страница 49: ...tamponaatio syd nl p n vauroituminen ja kohonnut fosfokinaasi Ei laitteeseen eik toimenpiteeseen liittyen virtsaretentio ohimenev raajojen tunnottomuutta Parkinsonin tauti ja ruuansulatuselimist n div...

Страница 50: ...iologisk kartl ggning stimulering och registrering och n r den anv nds tillsammans med en radiofrekvensgenerator f r hj rtablation Biosense Webster THERMOCOOL SMARTTOUCH Diagnostik ablationskatetern m...

Страница 51: ...skall utf ras av speciellt utbildad personal i ett fullt utrustat elektrofysiologiskt laboratorium L mplig klinisk anvisning f r anv ndning av Biosense Webster THERMOCOOL SMARTTOUCH diagnostik ablati...

Страница 52: ...tarna r ppna genom att spruta in hepariniserad normal saltl sning i katetern och r rledningssystemet 28 Inspektera regelbundet och testa teranv ndbara kablar och tillbeh r RF ablation Vid RF ablation...

Страница 53: ...fektappliceringar verskridande 30 W och upp till 50 W endast anv ndas om verf ringsblockering inte kan uppn s vid l gre effektniv er 15 Rekommendation f r irrigation ka irrigationen till h g fl deshas...

Страница 54: ...F R ETT SPECIELLT NDAM L F R DENNA PRODUKT ELLER DE PRODUKTER SOM H R BESKRIVS UNDER INGA OMST NDIGHETER KAN BIOSENSE WEBSTER INC ELLER N GOT AV DESS BOLAG H LLAS ANSVARIG F R SPECIELLA DIREKTA TILLF...

Страница 55: ...kert for bruk i kardial elektrofysiologisk kartlegging stimulering og registrering og n r brukt i sammen med en radiofrekvensgenerator for hjerteablasjon Biosense Webster THERMOCOOL SMARTTOUCH diagnos...

Страница 56: ...ekkelig oppl rt personale i et fullt utstyrt elektrofysiologisk laboratorium Hensiktsmessig klinisk instruksjon i hvordan Biosense Webster THERMOCOOL SMARTTOUCH diagnostisk ablasjonskateter med b yeli...

Страница 57: ...l elektrode kobles til inngangen for den n ytrale elektroden p RF generatoren Kontroller at kretsimpedansen f r RF ablasjon ligger innenfor de forventede parametrene Kontroller at RF generatoren viser...

Страница 58: ...e f r kningen i irrigasjonsflythastighet er bekreftet av minimum 2 C reduksjon i spisselektrodetemperaturen 17 Overv k kateterspissens temperatur gjennom hele prosedyren for sikre adekvat irrigasjon T...

Страница 59: ...IGE FOR DIREKTE TILFELDIGE ELLER ANDRE SKADER OG F LGESKADER ANNET ENN DET SOM ER UTTRYKKELIG NEDFELT I BESTEMTE LOVER UTEN BEGRENSNING I DET FOREG ENDE SKAL BIOSENSE WEBSTER INC ELLER DETS TILKNYTTED...

Страница 60: ...3 CARTO 3 CARTO 3 THERMOCOOL SMARTTOUCH Biosense Webster THERMOCOOL SMARTTOUCH Biosense Webster CARTO 3 1 2 3 4 5 6 7 1 2 3 CARTO 3 WARNING This is a controlled proprietary and confidential document V...

Страница 61: ...ARTTOUCH Biosense Webster 4 THERMOCOOL SMARTTOUCH Biosense Webster 5 WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documen...

Страница 62: ...MOCOOL SMARTTOUCH Biosense Webster 15 16 17 THERMOCOOL SMARTTOUCH Biosense Webster 18 19 MRI 20 21 THERMOCOOL SMARTTOUCH Biosense Webster 22 23 EMI THERMOCOOL SMARTTOUCH Biosense Webster 24 25 WARNING...

Страница 63: ...Webster THERMOCOOL SMARTTOUCH Biosense Webster 1 2 3 4 PREFACE 8 5 F 5 CARTO 3 PIU Biosense Webster PIU Biosense Webster PIU CARTO 3 Biosense Webster luer 1 ml 6 7 2 ml 8 THERMOCOOL SMARTTOUCH Biosens...

Страница 64: ...5 5 5 30 W 17 ml 31 50 W 30 ml 16 2 C 17 50 C 18 15 20 W 15 5 10 W 120 120 19 a 1 2 ml b 6 c a b d e f ARDS WARNING This is a controlled proprietary and confidential document Verify revision is curren...

Страница 65: ...ENSE WEBSTER INC Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con de...

Страница 66: ...ebilir U Kateteri kateter ucu ve kalp duvar aras ndaki temas g c n n ger ek zamanl l m n sa lar ve CARTO 3 Navigasyon Sistemi ile kullan ld nda konum bilgisi sa lar Kontrendikasyonlar Cihaz u durumlar...

Страница 67: ...lm personel taraf ndan yap lmal d r Biosense Webster THERMOCOOL SMARTTOUCH Tan sal Ablasyon B k lebilir U Kateteri kullan m konusunda da uygun klinik e itim tamamlanmal d r 5 Uzun s reli floroskopi ve...

Страница 68: ...yonu i in kateter RF jenerat r ne ba lanan CARTO 3 Hasta Aray z nitesine PIU ba lan r Kurulum i lemleri i in CARTO 3 Navigasyon sisteminize ait Kullanma K lavuzuna ba vurun Uygun RF jenerat r aray z i...

Страница 69: ...z kullan lmal d r Otuz bir ile elli W aras ndaki g d zeyleri i in 30 ml dk de erinde y ksek ak h z kullan lmal d r 16 RF enerjisi uygulamas irigasyon ak h z ndaki art u elektrodu s cakl ndaki minimum...

Страница 70: ...ER INC VEYA YAN KURULU LARI H B R EK LDE SPES F K KANUNLARDA A IK OLARAK SA LANANLAR DI INDA HERHANG B R ZEL DO RUDAN ARIZ SONU SAL VEYA BA KA HASARDAN SORUMLU OLMAYACAKTIR YUKARIDAK LER KISITLAMADAN...

Страница 71: ...CARTO 3 CARTO 3 Biosense Webster THERMOCOOL SMARTTOUCH Biosense Webster THERMOCOOL SMARTTOUCH CARTO 3 1 2 3 4 5 6 7 1 2 3 WARNING This is a controlled proprietary and confidential document Verify revi...

Страница 72: ...er THERMOCOOL SMARTTOUCH 4 Biosense Webster THERMOCOOL SMARTTOUCH 5 WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un document...

Страница 73: ...iosense Webster THERMOCOOL SMARTTOUCH 15 16 17 Biosense Webster THERMOCOOL SMARTTOUCH 18 19 20 21 Biosense Webster THERMOCOOL SMARTTOUCH 22 23 EMI Biosense Webster THERMOCOOL SMARTTOUCH 24 25 WARNING...

Страница 74: ...OUCH Biosense Webster THERMOCOOL SMARTTOUCH Biosense Webster 1 2 3 4 PREFACE 8 5 F 5 CARTO 3 PIU Biosense Webster PIU Biosense Webster PIU CARTO 3 Biosense Webster 3 1 6 7 2 8 Biosense Webster THERMOC...

Страница 75: ...50 15 5 5 30 17 31 50 30 16 2 C 17 50 C 18 15 20 15 5 10 120 120 19 a 1 2 b 6 c a b d e f WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVI...

Страница 76: ...BSTER INC Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con derechos...

Страница 77: ...systemu nawigacji CARTO 3 Do cel w lokalizacji pozycji odniesienia potrzebne jest odpowiednie urz dzenie odniesienia Informacje na temat stosowania w procedurach mapowania u ywania odpowiednich urz dz...

Страница 78: ...i kszenie ryzyka skutk w somatycznych i genetycznych zar wno u pacjent w jak i personelu a wielko tych uszkodze zale y od intensywno ci promieniowania X i czasu trwania obrazowania fluoroskopowego Abl...

Страница 79: ...z cewnikiem lub elektrod oboj tn mo e spowodowa obra enia pacjenta lub operatora zw aszcza w trakcie pos ugiwania si urz dzeniem W czasie gdy do urz dzenie dop ywa pr d elektryczny pacjent nie powinie...

Страница 80: ...dko ci przep ywu 2 ml min 8 Wprowadzi cewnik diagnostyczno ablacyjny Biosense Webster THERMOCOOL SMARTTOUCH przez naci cie stosuj c rurk wprowadzaj c i koszulk introduktora odpowiedniego rozmiaru Dopr...

Страница 81: ...ocedury ablacji za pomoc cewnika w tym zator t tnicy p ucnej zawa serca udar tamponada serca i zgon Stwierdzono r wnie we wcze niejszych badaniach lub opisano w literaturze nast puj ce powik ania Zwi...

Страница 82: ...ko abla n kat tr s oh bateln m hrotem Biosense Webster THERMOCOOL SMARTTOUCH a se schopnost sn mat kontaktn s lu umo uje m en relativn kontaktn s ly v re ln m ase mezi hrotem kat tru a srde n st nou s...

Страница 83: ...d t v hradn l ka i s adekv tn specializac v pln vybaven elektrofyziologick laborato i Je rovn zapot eb splnit p slu n klinick pokyny pro pou v n diagnosticko abla n ch kat tr Biosense Webster THERMOC...

Страница 84: ...bely a p slu enstv ur en k opakovan mu pou it RF ablace Pro RF ablac se kat tr mus p ipojit k jednotce zaji uj c rozhran pacienta PIU naviga n ho syst mu CARTO kter jej p ipoj k RF gener toru Postupy...

Страница 85: ...ladin ch 15 Doporu en pro irigaci Zvy te irigaci na vysok pr tok a za n te do 5 sekund p ed zah jen m p vodu RF energie a udr ujte tento vy pr tok a 5 sekund po ukon en aplikace energie Pro rovn v kon...

Страница 86: ...V NA DN V SLOVN ANI ODVOZEN Z RUKA MIMO JIN NA OBCHODOVATELNOST A VHODNOST KE KONKR TN MU ELU SPOLE NOST BIOSENSE WEBSTER INC ANI JEJ P IDRU EN SPOLE NOSTI NEJSOU ZA DN CH OKOLNOST ODPOV DN ZA DN ZVL...

Страница 87: ...CARTO 3 navig ci s rendszer felhaszn l i k zik nyve tartalmaz Javallatok A Biosense Webster THERMOCOOL SMARTTOUCH diagnosztikai abl ci s hajl that v g kat ter a sz v elektrofiziol giai felt rk pez s r...

Страница 88: ...hat s nak 17 Ne kezelje a kat tert autokl vban 18 Ne mer tse a k zelebb es foganty t vagy a k belcsatlakoz t folyad kba mivel ez k rosan befoly solhatja az elektromos teljes tm nyt 19 Tiszt t s alatt...

Страница 89: ...thet de nem k sz b lhet ki az ltal hogy a lehet legt volabb helyezi az elektr d kat s a szond kat az abl ci helysz n t l s a semleges elektr d t l V d impedanci k cs kkenthetik az g si s r l sek kock...

Страница 90: ...eolvasott nyom er olyan ingadoz sai melyek a sz vmozg sokkal illetve a l gz si ciklussal sszhangban vannak azt jelentheti hogy a kat ter a sz v strukt r ival rintkezik Amint ezek a jel l k azt mutatj...

Страница 91: ...defibrill tor ICD elvezet s meghib sod sa an mia trombocitop nia disszemin lt intravaszkul ris koagul ci orrv rz s sziszt m s fert z s h gyvezet k fert z s altat s induk lt apno letargi val s epeh ly...

Страница 92: ...OCOOL SMARTTOUCH poskytuje priebe n meranie kontaktnej sily medzi hrotom kat tra a srdcovou stenou ako aj inform cie o polohe pri pou it s naviga n m syst mom CARTO 3 Kontraindik cie Toto zariadenie n...

Страница 93: ...aj pr slu n klinick pokyny na pou itie diagnostick ho a abla n ho kat tra s ovl date n m hrotom Biosense Webster THERMOCOOL SMARTTOUCH 5 Dlhodob rizik dlhotrvaj cej fluoroskopie a vznik l zii indukova...

Страница 94: ...ortov pre erpan m fyziologick ho roztoku cez kat ter 28 Pravidelne kontrolujte a testujte opakovane pou van k ble a pr slu enstvo RF abl cia Pri RF abla n ch z krokoch je kat ter pripojen do jednotky...

Страница 95: ...sek nd 60 a 120 sek nd Ak sa transmur lna l zia ned dosiahnu pri ni ch energetick ch rovniach m u sa pou i rovne presahuj ce hodnotu 30 W Pri nastaven v konu na rove vy iu ako 30 W sa odpor a iriga n...

Страница 96: ...t ri kardi lny tromboembolizmus perikardit da perfor cia a tampon da srdca po kodenie chlopne a zv en hladina fosfokin zy Komplik cie nevyvolan zariaden m ani z krokom urin rna retencia do asn strata...

Страница 97: ...vezavi z radiofrekven nim generatorjem Diagnosti no ablacijski kateter Biosense Webster THERMOCOOL SMARTTOUCH daje v realnem asu meritve sile na stiku med konico katetra in steno srca kakor tudi podat...

Страница 98: ...e ustrezno usposobljeno osebje v popolnoma opremljenem elektrofiziolo kem laboratoriju Dolo iti je potrebno tudi ustrezna klini na navodila za uporabo diagnosti no ablacijskega katetra z upogibno koni...

Страница 99: ...snik PIU Jednotka rozhrania pacienta tipa CARTO 3 tega pa na RF generator Postopek priprave je opisan v uporabni kem priro niku navigacijskega sistema CARTO 3 za priklop RF generatorja uporabite kable...

Страница 100: ...ih mo i med 31 in 50 W uporabite za visoko stopnjo pretok 30 ml min 16 Z uporabo RF energije ne smete pri eti dokler pove anje stopnje pretoka ni potrjeno z zni anjem temperature v vrhnji elektrodi za...

Страница 101: ...ERU NE ODGOVARJAJO ZA KAKR NOKOLI POSEBNO NEPOSREDNO SLU AJNO POSLEDI NO ALI DRUGA NO OBLIKO KODE RAZEN E TO NI IZRECNO DOLO ENO S KAKIM SPECIFI NIM ZAKONOM BREZ OMEJEVANJA ZGORAJ NAVEDENEGA BIOSENSE...

Страница 102: ...O 3 CARTO 3 THERMOCOOL SMARTTOUCH Biosense Webster THERMOCOOL SMARTTOUCH Biosense Webster CARTO 3 1 2 3 4 5 6 7 1 2 3 CARTO 3 4 contact force WARNING This is a controlled proprietary and confidential...

Страница 103: ...ARTTOUCH Biosense Webster 4 THERMOCOOL SMARTTOUCH Biosense Webster 5 6 3 7 THERMOCOOL SMARTTOUCH Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is...

Страница 104: ...15 16 17 THERMOCOOL SMARTTOUCH Biosense Webster 18 19 20 21 Biosense Webster THERMOCOOL SMARTTOUCH RF 22 23 Biosense Webster THERMOCOOL SMARTTOUCH RF 24 25 RF 26 Biosense Webster THERMOCOOL SMARTTOUC...

Страница 105: ...SMARTTOUCH Biosense Webster Biosense Webster 1 2 3 4 PREFACE 8 5 F 5 RF CARTO 3 Biosense Webster Biosense Webster CARTO 3 Biosense Webster 3 1 U ml RF 6 7 2 ml min 8 THERMOCOOL SMARTTOUCH Biosense Web...

Страница 106: ...ml min 31 50 W 30 ml min 16 RF 2 C 17 50 C RF 18 15 20 W 15 5 10 W RF 120 120 19 RF contact force a 1 2 ml b 6 c a b d e f ARDS CO2 WARNING This is a controlled proprietary and confidential document...

Страница 107: ...WEBSTER INC Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con derecho...

Страница 108: ...informa ii referitoare la dispozitivele de referin corespunz toare precum i pentru descrierea detaliat a func ion rii sistemului CARTO 3 consulta i Manualul de utilizare al sistemului de naviga ie CA...

Страница 109: ...torul de cablu n lichide poate fi afectat performan a electric 19 Nu freca i sau ndoi i electrodul cap tului distal n timpul cur rii 20 Anterior utiliz rii n procedur verifica i solu ia de ser fiziolo...

Страница 110: ...rodului din v rf nu temperatura esutului Temperatura afi at pe generatorul de RF este cea a electrodului r cit nu cea a esutului Dac generatorul nu afi eaz temperatura verifica i dac la generator este...

Страница 111: ...a de contact c nd deplasa i cateterul dintr o camer a cordului ntr alta sau la reintroducere 13 V rful cateterului poate fi deflectat pentru a facilita pozi ionarea prin utilizarea butonului pentru a...

Страница 112: ...itmie ventricular TIA CVA blocaj total al cordului spasm al arterei coronare tromboza arterei coronare disec ia arterei coronare tromboembolism cardiac pericardit perforare tamponad cardiac deteriorar...

Страница 113: ...ARTTOUCH diagnostiline k rvalejuhitava ablatsiooniotsaga kateeter mis v imaldab kateetri otsa ja s dameseina vahelise kontaktj u reaalajam tmist ning v ib anda lokatsiooniandmeid kui seda kasutada koo...

Страница 114: ...e instrueerimine kus k sitletakse Biosense Webster THERMOCOOL SMARTTOUCH diagnostilise k rvalejuhitava ablatsiooniotsaga kateetri kasutamist 5 Protraktse fluoroskoopia pikaajalisi ohte ega k rgsagedus...

Страница 115: ...RF ablatsiooni l biviimiseks hendatakse kateeter CARTO 3 patsiendiliidesplokiga PIU mis hendatakse RF generaatoriga H lestamise protseduure vaadake CARTO 3 navigatsioonis steemi kasutusjuhendist N uet...

Страница 116: ...rrigatsiooni voolukiirust maksimaalseni alustades kuni 5 sekundit enne RF energia edastamise algust ning s ilitades suure voolukiiruse kuni 5 sekundit p rast energia rakendamise l petamist V imsustase...

Страница 117: ...PIIRANGUD SIINKIRJELDATUD TOO DE TELE EI ANTA MINGISUGUST OTSEST V I KAUDSET GARANTIID SEALHULGAS MIS TAHES KAUDSEID GARANTIISID SEOSES M GIK LBLIKKUSE V I KINDLAKS OTSTARBEKS SOBIVUSEGA BIOSENSE WEB...

Страница 118: ...indic ts lieto anai sirds elektrofiziolo iskaj kart an stimul an un re istr an un lietojot kop ar radiofrekvences eneratoru ekstirp cijai sird Biosense Webster THERMOCOOL SMARTTOUCH diagnostikas ekst...

Страница 119: ...Sirds ekstirp cijas proced ras dr kst veikt atbilsto i apm c ts person ls piln b apr kot elektrofiziolo ijas laboratorij Ir j pabeidz ar atbilsto a kl nisk apm c ba par Biosense Webster THERMOCOOL SMA...

Страница 120: ...rbaudiet vai ir k rt b irig cijas atveres 28 Regul ri apskatiet un p rbaudiet atk rtoti izmantojamos kabe us un piederumus RF ekstirp cija RF ekstirp cijas vajadz b m katetrs ir pievienots pie CARTO 3...

Страница 121: ...t tikai t d gad jum ja vad anas blok di nevar pan kt ar maz ku jaudas l meni 15 Leteikumi irig cijai Palieliniet irig ciju l dz lielam pl smas trumam apm ram 5 sekundes pirms RF ener ijas pievad anas...

Страница 122: ...BE OJUMI UZ EIT APRAKST TO IEM RA OJUMU IEM NEATTIECAS TIE I VAI NETIE I IZTEIKTA GARANTIJA IESKAITOT JEBK DU NETIE I IZTEIKTU GARANTIJU ATTIEC B UZ KOMERCI LO KVALIT TI VAI DER GUMU NOTEIKT M VAJADZ...

Страница 123: ...tas elektrofiziologiniam irdies kartografavimui stimuliavimui ir ra ymui ir naudojant su radioda numiniu generatoriumi irdies abliacijai Biosense Webster THERMOCOOL SMARTTOUCH diagnostinis abliacinis...

Страница 124: ...iologiniai kateteriai ir sistemos yra skirtos naudoti tik nuo rentgeno spinduli apsaugotose patalpose 3 Nenaudokite Biosense Webster THERMOCOOL SMARTTOUCH diagnostinio abliacinio kateterio lanks iu ga...

Страница 125: ...kur b tina pa alinti prie jungiant radijo da nius 26 Biosense Webster THERMOCOOL SMARTTOUCH diagnostinio abliacinio kateterio lanks iu galiuku temperat ros matavimo tikslumas kaip bet koki elektrofiz...

Страница 126: ...lygiai vir ijantys 30 W gali b ti naudojami kai esant ma esniems energijos lygiams negalima sukurti tarpusienio pakitim Energijos nustatymams 30 W rekomenduojama irigacijos da nio t km 30 ml min Jei r...

Страница 127: ...tromboembolija perikarditas irdies perforacija tamponada vo tuv pa eidimas padid j s fosfokinez s aktyvumas Nesusij su prietaisu ar proced romis lapimo sulaikymas praeinantis gal ni sustingimas Parki...

Страница 128: ...nse Webster THERMOCOOL SMARTTOUCH CARTO 3 Biosense Webster THERMOCOOL SMARTTOUCH 1 2 3 4 5 6 7 1 2 3 CARTO 3 4 5 6 7 8 9 10 11 50 C 12 ICD ICD 13 14 X WARNING This is a controlled proprietary and conf...

Страница 129: ...ster 14 Biosense Webster THERMOCOOL SMARTTOUCH 15 16 17 Biosense Webster THERMOCOOL SMARTTOUCH 18 19 MRI 20 X 21 Biosense Webster THERMOCOOL SMARTTOUCH 22 23 Biosense Webster THERMOCOOL SMARTTOUCH EMI...

Страница 130: ...6 7 2 ml min 8 Biosense Webster THERMOCOOL SMARTTOUCH 9 X EGM 10 CARTO 3 15 5 11 X CARTO EGM CARTO 3 12 13 14 1 1 15 W 30 W 31 W 50 W 50 C 50 C 17 ml min 30 ml min 30 120 60 120 30 W 30 W 30 ml min 30...

Страница 131: ...BSTER INC BIOSENSE WEBSTER INC Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confide...

Страница 132: ...3 CARTO 3 Biosense Webster THERMOCOOL SMARTTOUCH RF Biosense Webster THERMOCOOL SMARTTOUCH CARTO 3 1 8 2 3 4 5 6 7 1 2 0 3 0 0 0 CARTO 3 4 0 5 6 RF RF RF 7 WARNING This is a controlled proprietary and...

Страница 133: ...F 11 12 ANSI AAMI AAMI IEC 60601 2 2 3M 1149F Valley Lab 7505 13 Biosense Webster THERMOCOOL SMARTTOUCH RF CARTO 3 Biosense Webster 14 Biosense Webster THERMOCOOL SMARTTOUCH RF 15 16 17 Biosense Webst...

Страница 134: ...RTTOUCH Biosense Webster THERMOCOOL SMARTTOUCH 5 25 C 41 77 F CARTO 3 RF Biosense Webster THERMOCOOL SMARTTOUCH Biosense Webster Biosense Webster THERMOCOOL SMARTTOUCH 1 2 3 4 PREFACE 8 5 F 5 CARTO 3...

Страница 135: ...W 30 W 30 ml RF 30 W 50 W 15 RF 5 5 30 W 17 ml 31 50 W 30 ml 16 RF 2 C 17 RF 50 C 18 15 20 W 15 5 10 W RF 120 120 19 RF RF 6 a 1 2 ml b 6 c a b d e f 0 AV ARDS ICD CO2 RF TIA CVA WARNING This is a con...

Страница 136: ...TER INC Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con derechos re...

Страница 137: ...OOL SMARTTOUCH radiofrequency RF Biosense Webster THERMOCOOL SMARTTOUCH CARTO 3 1 2 3 4 5 6 7 1 2 3 CARTO 3 4 5 6 RF RF RF 7 8 9 10 11 50 C 12 implantable cardioverter defibrillator ICD RF ICD 13 RF W...

Страница 138: ...TOUCH RF 15 16 17 Biosense Webster THERMOCOOL SMARTTOUCH 18 19 MRI 20 X 21 Biosense Webster THERMOCOOL SMARTTOUCH RF 22 23 Biosense Webster THERMOCOOL SMARTTOUCH RF Electromagnetic interference EMI 24...

Страница 139: ...e Webster 3 1 u ml 6 7 2 ml 8 Biosense Webster THERMOCOOL SMARTTOUCH 9 EGM 10 CARTO 3 15 5 11 CARTO EGM CARTO 3 12 13 14 RF 1 1 RF RF 15 W 30 W 31 W 50 W 50 C 50 C RF 17 ml 30 ml 30 120 60 120 30 W 30...

Страница 140: ...INC BIOSENSE WEBSTER INC Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial...

Страница 141: ...RNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con derechos reservados Revisar si es la r...

Страница 142: ...RNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con derechos reservados Revisar si es la r...

Страница 143: ...RNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un documento controlado confidencial y con derechos reservados Revisar si es la r...

Страница 144: ...n Catheter and accessories are protected under one or more of the following U S Patents 5 383 923 5 391 199 5 443 489 5 462 521 5 480 422 5 546 951 5 558 091 5 568 809 5 694 945 5 713 946 5 718 241 5...

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