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8 M-5276-658A

Adverse Reactions

A number of serious adverse reactions have been documented for catheter
ablation procedures including pulmonary embolism, myocardial infarction, stroke,
cardiac tamponade, and death.

The following complications were also noted to have occurred during prior
studies or have been reported in the literature:
1. Catheterization/catheter procedure related: vascular bleeding/local

hematomas, thrombosis, AV fistula, pseudoaneurysm, thromboembolism and
vasovagal reactions, cardiac perforation, pericardial effusion/tamponade,
thrombi, air embolism, arrhythmias and valvular damage, pneumothorax and
hemothorax, pulmonary edema, hypoxia, pleural effusion, acute respiratory
distress syndrome (ARDS), congestive heart failure, aspiration pneumonia,
pneumonia, asthmatic attack, hypotension, ICD lead malfunction, anemia,
thrombocytopenia, disseminated intravascular coagulation, epistaxis,
systemic infection, urinary tract infection, sedation induced apnea, sedation
induced CO

2

retention with lethargy and cholecystitis.

2. RF related: chest pain/discomfort, ventricular tachyarrhythmia, TIA, CVA,

complete heart block, coronary artery spasm, coronary artery thrombosis,
coronary artery dissection, cardiac thromboembolism, pericarditis, cardiac
perforation/tamponade, valvular damage and increased phosphokinase level.

3. Unrelated to device or procedure: urinary retention, transient extremity

numbness, Parkinson’s disease and gastrointestinal diverticulosis.

DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY

THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ON THE PRODUCT(S)
DESCRIBED HEREIN. UNDER NO CIRCUMSTANCES SHALL
BIOSENSE WEBSTER, INC., OR ITS AFFILIATED COMPANIES, BE LIABLE
FOR ANY SPECIAL, DIRECT, INCIDENTAL, CONSEQUENTIAL, 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, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES, ARISING
OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE
OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW.

Descriptions and specifications appearing in Biosense Webster, Inc. printed
matter, including this publication, are informational only and meant solely to
generally describe the product at the time of manufacture and are not made or
given as a warranty of the prescribed product in any way.

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 reservados. Revisar si es la revision mas actualizada.

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Содержание Biosense Webster ThermoCool

Страница 1: ...sowania iagnostyczno ablacyj OOL SF z ruchom ko k pou it icko abla n kat tr TH n m hrotem ati tmutat OOL SF diagnosztiku kat ter na pou itie ick a abla n kat te e n m hrotom THERM a za uporabo OOL SF...

Страница 2: ...jumiem r pridedamas Naudojimo instrukcij Do not use open or damaged packages Ne pas utiliser si l emballage est ouvert ou endommag Ge ffnete oder besch digte Verpackungen nicht verwenden Non utilizza...

Страница 3: ...op ischen Gemeinschaft Rappresentante nell Unione Europea Representante en la Comunidad Europea Representante na Comunidade Europeia Erkend vertegenwoordiger in de Europese Unie Repr sentant i de Euro...

Страница 4: ...3 In patients with prosthetic valves as the catheter may damage the prosthesis 4 In the coronary vasculature due to risk of damage to the coronary arteries 5 In patients with an active systemic infec...

Страница 5: ...withdraw the catheter when resistance is encountered The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart 27 Always place the Rocker Lever in the neutra...

Страница 6: ...mise the structural integrity of the device and or lead to device failure that in turn may result in patient injury illness or death Also reprocessing or resterilization of single use devices may crea...

Страница 7: ...imum of 2 C decrease in tip dome electrode temperature 15 Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation Note the displayed temperature represents the temp...

Страница 8: ...perforation tamponade valvular damage and increased phosphokinase level 3 Unrelated to device or procedure urinary retention transient extremity numbness Parkinson s disease and gastrointestinal diver...

Страница 9: ...soires sont indiqu s pour les cartographies lectrophysiologiques cardiaques cardiaques faites par cath ter stimulation et enregistrement et quand il est utilis avec un g n rateur de radiofr quences po...

Страница 10: ...r le cath ter et les tubulures d irrigation l aide de s rum physiologique normal h parin 21 Les cath ters et syst mes d lectrophysiologie sont pr vus pour tre utilis s uniquement dans les salles de ra...

Страница 11: ...ilisateur du g n rateur RF utilis en ce qui concerne les sp cifications de pr cision de la temp rature 46 Avant utilisation v rifier que les orifices d irrigation sont ouverts en infusant du s rum phy...

Страница 12: ...mes facilite le positionnement appropri 11 D flexion des cath ters Utiliser le levier pivotant pour fl chir l extr mit du cath ter figure 1 Quand le levier est ramen en arri re partir de la position n...

Страница 13: ...u s il ne fonctionne pas correctement NOTE Une petite seringue fournit une pression suffisante pour produire un filet de liquide visible R actions ind sirables Plusieurs r actions ind sirables graves...

Страница 14: ...uerbarer Spitze und sein Zubeh r sind f r auf Katheter basierendes kardiologisches elektrophysiologisches Mapping Stimulation und Aufzeichnung sowie in Verbindung mit einem HF Chirurgie Ger t f r kard...

Страница 15: ...Spitze w hrend der Reinigung nicht 19 Untersuchen Sie die Kochsalzl sung f r die Sp lung vor der Anwendung auf Luftblasen Luftblasen in der Kochsalzl sung k nnen Embolien verursachen 20 Sp len Sie de...

Страница 16: ...chung des Elektrokardiogramms w hrend der Abgabe von Energie 44 Der Temperatursensor misst die Temperatur der Elektrodenspitze und nicht die Gewebetemperatur Die auf dem HF Generator angezeigte Temper...

Страница 17: ...sung 1 u Heparin ml bei Raumtemperatur an ffnen Sie den Absperrhahn am Ende des Irrigationsschlauches und f llen Sie den Irrigationsschlauch so langsam wie m glich auf Entfernen Sie alle Luftblasen u...

Страница 18: ...berpr fen ehe erneut mit HF Strom gearbeitet wird Zum Entfernen des Koagulats kann ein steriler mit Kochsalzl sung befeuchteter Mulltupfer verwendet werden Beim Reinigen der Elektrode an der Katheters...

Страница 19: ...IREKTE 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 ANWENDBARES RECHT UNTERS...

Страница 20: ...registrazione basato su catetere e quando usato in combinazione con un generatore di radiofrequenza per l ablazione cardiaca Controindicazioni Non utilizzare questo catetere 1 Se il paziente stato so...

Страница 21: ...ve istruzioni per l uso 23 Gli interventi di ablazione cardiaca devono essere effettuati da personale debitamente preparato in un laboratorio di elettrofisiologia completamente attrezzato anche opport...

Страница 22: ...al connettore ai connettori di ingresso appropriati sul generatore RF Per un interfacciamento corretto usare solo cavi di interfaccia Biosense Webster o compatibili Per completare il circuito elettric...

Страница 23: ...bilanciere in posizione neutrale Figura 1 L impugnatura dotata di un controllo dell attrito regolabile che consente all operatore di usare la leva a bilanciere e di flettere la punta in uno stato libe...

Страница 24: ...entate alcune gravi reazioni avverse tra cui embolia polmonare infarto del miocardio ictus tamponamento cardiaco e morte In studi precedenti o in letteratura sono state inoltre riportate le seguenti c...

Страница 25: ...dirigible para diagn stico ablaci n y los accesorios correspondientes est n indicados para efectuar el mapeo electrofisiol gico del coraz n estimulaci n y registro y para uso junto con un generador de...

Страница 26: ...ctromagn tica y otras directrices de seguridad del centro m dico 22 No intente usar el cat ter de Biosense Webster THERMOCOOL SF de punta dirigible para ablaci n y diagn stico ni el generador RF sin h...

Страница 27: ...t ter y los tubos 47 Inspeccione y verifique con regularidad los cables y los accesorios reutilizables Ablaci n con RF Para la ablaci n con radiofrecuencia el cat ter debe estar conectado a las tomas...

Страница 28: ...1 Cuando retire la palanca de su posici n neutra la punta se orientar seg n la direcci n del giro El grado de orientaci n es relativo al giro de la palanca Si empuja la palanca hacia delante la punta...

Страница 29: ...ble de l quido Reacciones adversas Se han documentado diversos efectos secundarios adversos derivados de la ablaci n con cat ter incluida la embolia pulmonar el infarto de miocardio el accidente cereb...

Страница 30: ...ofisiol gico baseado com cateter estimula o e grava o e quando utilizado em conjunto com um gerador de radiofrequ ncia para a abla o card aca Contra indica es N o utilize este cateter 1 Se o paciente...

Страница 31: ...italar 22 N o tentar utilizar o Cateter de Ponta Deflect vel para Diagn stico Abla o Biosense Webster THERMOCOOL SF ou o gerador de RF antes de ler e compreender completamente as Instru es de Utiliza...

Страница 32: ...a especifica o da precis o da temperatura no Manual do Utilizador do gerador de RF a utilizar 46 Antes da utiliza o verificar se os orif cios de irriga o est o desobstru dos irrigando o cateter e os...

Страница 33: ...o correcto 11 Deflex o dos cateteres Utilize o man pulo oscilante para deflectir a ponta do cateter Figura 1 Quando o man pulo for puxado desde a posi o neutra a ponta deflecte se na direc o da rota o...

Страница 34: ...er se ainda estiver obstru do ou se n o estiver a funcionar devidamente NOTA Uma pequena seringa fornece press o suficiente para produzir um fluxo de l quido vis vel Reac es adversas Foram documentada...

Страница 35: ...requentiegenerator voor cardiale ablatie Contra indicaties Gebruik deze katheter niet 1 als de pati nt een ventriculotomie of atriotomie heeft ondergaan in de afgelopen acht weken aangezien een dergel...

Страница 36: ...oet de toepasselijke klinische instructie in het gebruik van de THERMOCOOL SF diagnostische ablatiekatheter met buigbare tip ook worden voltooid 24 De risico s op lange termijn van langdurige fluorosc...

Страница 37: ...katheter zijn aangesloten op de juiste ingangconnector en op de RF generator Gebruik voor een juiste interface alleen een Biosense Webster of compatibele interfacekabel Om het elektrische circuit te s...

Страница 38: ...echt wilt maken brengt u de draaiknop terug in de neutrale stand Afbeelding 1 De knop heeft een regelbare frictieregeling waarmee de gebruiker de draaiknop en de buigbare tip kan gebruiken in een vrij...

Страница 39: ...e katheterisatie ingrepen zoals longembolie hartinfarct herseninfarct cardiale tamponnade en overlijden De volgende complicaties zijn tevens gerapporteerd als opgetreden tijdens eerdere onderzoeken of...

Страница 40: ...kan ge risikoen for perforering 2 P patienter med myxom intrakardial trombe idet kateteret kan risikere at fremprovokere emboli 3 P patienter med hjerteklapproteser idet kateteret kan beskadige prote...

Страница 41: ...koagulationsbehandling 26 Ved anvendelse af Biosense Webster THERMOCOOL SF diagnostiske ablationskatetre sammen med konventionelle systemer under brug af fluoroskopi til bestemmelse af placering af ka...

Страница 42: ...everes s rskilt Opbevaring THERMOCOOL SF diagnosticerings ablationskateter med b jelig spids skal opbevares p et t rt og k ligt sted Opbevaringstemperaturen skal ligge imellem 5 og 25 C 41 og 77 F Ste...

Страница 43: ...n h je gennemstr mningshastighed op til 5 sekunder efter afbrydelsen af RF energitilf rslen Ved effektniveauer op til 30 watt b r der v lges en h j gennemstr mningshastighed p 8 ml min Ved effektnivea...

Страница 44: ...mbolisme i hjertet perikarditis kardioperforering tamponade skade p klapper og forh jet fosfokinase 3 Urelaterede til enheden eller proceduren Urinrenetention forbig ende f lelsesl shed i ekstremitete...

Страница 45: ...eksan viikon aikana koska leikkaus voi lis t perforointiriski 2 Jos potilaalla on myksooma tai syd mensis inen veritulppa sill katetri voi edist veritulppaa 3 Jos potilaalla on l pp proteesi sill kate...

Страница 46: ...n tromboembolioiden est miseksi laskimonsis ist hepariinia Lis ksi useat l k rit m r v t aspiriinia harvemmin varfariinia noin 3 kuukaudeksi toimenpiteen j lkeen Konsensusta lyhytaikaisen antigoakulaa...

Страница 47: ...ametrej Tarkkaile aina l mp tilaa ja impedanssin nousua THERMOCOOL SF taivutettavak rkisen diagnostisen ablaatiokatetrin k yt n aikana Toimitustapa THERMOCOOL SF taivutettavak rkinen diagnostinen abla...

Страница 48: ...ablaatioon 30 W 50 W tehoa voidaan k ytt ainoastaan jos johtumiskatkosta ei saavuteta alemmilla virran voimakkuuksilla 13 Huuhtelusuositukset Lis huuhteluvirtaus korkeaksi viimeist n 5 sekuntia ennen...

Страница 49: ...s ja kolekystiitti 2 Radiotaajuuteen liittyen rintakipu ep mukavuus kammiotakyarytmia ohimenev aivoverenkiertoh iri TIA aivohalvaus CVA t ydellinen syd nkatkos sepelvaltimospasmi sepelvaltimotukos sep...

Страница 50: ...n intrakardiell trombos eftersom katetern pl tsligt kan framkalla en embolus 3 i patienter med protesklaffar eftersom katetern kan skada protesen 4 i kransk rlen p grund av risken f r skada p kransk r...

Страница 51: ...a tillbaka katetern vid motst nd Den fl tade spetsens h rdhet g r att f rsiktighet m ste iakttas f r att f rhindra perforering av hj rtat 27 Placera alltid vridknoppen i neutral position f r att r ta...

Страница 52: ...gsbruk teranv nd omarbeta eller omsterilisera inte p nytt teranv ndning omarbetning eller omsterilisering kan ventyra produktens strukturella integritet och eller leda till att det blir fel p enheten...

Страница 53: ...skning p minst 2 C av spetselektrodens temperatur 15 vervaka kateterspetsens temperatur genom hela proceduren f r att s kerst lla adekvat irrigation Anm rkning Den visade temperaturen terger endast el...

Страница 54: ...de till enhet eller procedur urinretention verg ende extremitetsdomningar Parkinsons sjukdom och gastrointestinal divertikulit FRISKRIVNING OCH ANSVARSBEGR NSNINGAR DET FINNS INGEN UTTRYCKLIG GARANTI...

Страница 55: ...ventiler ettersom kateteret kan skade protesen 4 I den koronare vaskulaturen p grun av risikoen for skade p koronararteriene 5 I pasienter med en aktiv systemisk infeksjon fordi dette kan ke risikoen...

Страница 56: ...ege kateteret fram eller tilbake hvis kateteret m ter motstand Stivheten til den flettede spissen dikterer at det m utvises forsiktighet for hindre perforering av hjertet 27 Plasser alltid vippespaken...

Страница 57: ...resterilisering kan skade strukturen til enheten og eller f re til at den svikter noe som i sin tur kan f re til pasientskade sykdom eller d d Dessuten kan gjenbehandling eller resterilisering av enh...

Страница 58: ...ke vevets temperatur 16 Bebynn prosedyren ved 15 20 Watt Etter 15 sekunder kan str mtilf rselen kes med 5 10 W etter behov helt til transmural lesjon er oppn dd definert av 80 reduksjon i unipolar atr...

Страница 59: ...TIBEGRENSNING DET FINNES INGEN UTTRYKT ELLER UNDERFORST TT GARANTI INNBEFATTET UTEN BEGRENSNING UNDERFORST TTE GARANTIER OM SALGBARHET ELLER EGNETHET FOR ET BESTEMT FORM L FOR PRODUKTET PRODUKTENE SOM...

Страница 60: ...J BF DF luer CARTO EP THERMOCOOL SF Nav THERMOCOOL SF Biosense Webster 1 2 3 4 5 6 7 1 2 3 4 5 WARNING This is a controlled proprietary and confidential document Verify revision is current prior to us...

Страница 61: ...on Circulation 2006 114 257 354 7 8 40 C 9 ICD ICD 10 11 12 13 14 15 16 17 18 19 20 21 X 22 THERMOCOOL SF Biosense Webster 23 THERMOCOOL SF 24 25 3 26 THERMOCOOL SF Biosense Webster 27 28 29 30 WARNIN...

Страница 62: ...e Webster 41 42 EMI THERMOCOOL SF Biosense Webster 43 44 45 THERMOCOOL SF Biosense Webster 46 47 Biosense Webster 37 C 1 THERMOCOOL SF THERMOCOOL SF EtO THERMOCOOL SF BB DD FF JJ BD FJ DJ BF DF WARNIN...

Страница 63: ...ster 5 1 ml 6 7 luer THERMOCOOL SF 8 9 2 ml 10 THERMOCOOL SF 8 F 11 1 1 2 off on off on WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO...

Страница 64: ...31 50 W 15ml 14 2 C 15 16 15 20 W 15 5 10 W 80 50 W 35 W 120 120 17 a 1 2 ml b c a b d e 1 WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use A...

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

Страница 66: ...lan hastalarda bu durum kardiyak enfeksiyon riskini art rabilece i i in 6 nteratriyal baffle veya yama bulunan hastalarda transseptal yakla mla a kl k bir iyatrojenik atriyal anta sebep olabilece i i...

Страница 67: ...e kateter ucunu d zle tirmek i in Esnek Kolu daima n tr konuma getiriniz 28 Kateter l meni i inde koag lasyonu nlemek i in daima s rekli bir heparinize normal salin inf zyonu sa lay n z 29 RF ak m bir...

Страница 68: ...eme tabi tutulmas veya tekrar sterilize edilmesi cihaz n yap sal b t nl n tehlikeye sokabilir ve veya hastan n yaralanmas hastalanmas veya l m ne neden olabilecek cihaz ar zas na sebep olabilir Tek ku...

Страница 69: ...nca izleyiniz Not g sterilen s cakl k dokunun s cakl n de il sadece elektrodun s cakl n temsil etmektedir 16 leme 15 20 Watt ile ba lay n z 15 saniyeden sonra unipolar atriyal elektrogram amplit d nde...

Страница 70: ...tansiyon ge ici ekstremite uyu mas Parkinson hastal ve gastrointestinal divertik lozis GARANT REDD VE Y K ML L K KISITLAMASI BURADA TANIMLANAN R N LER N SATILAB L RL K VE HERHANG B R AMACA UYGUNLUK A...

Страница 71: ...J DJ BF DF CARTO EP THERMOCOOL SF NAV Biosense Webster THERMOCOOL SF 1 2 3 4 5 6 7 1 2 3 4 5 WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use...

Страница 72: ...Circulation 2006 114 257 354 7 8 40 C 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Biosense Webster THERMOCOOL SF 23 Biosense Webster THERMOCOOL SF 24 25 3 26 Biosense Webster THERMOCOOL SF 27 28 29 WARN...

Страница 73: ...OOL SF 37 38 39 40 Biosense Webster THERMOCOOL SF 41 42 Biosense Webster THERMOCOOL SF 43 44 45 Biosense Webster THERMOCOOL SF 46 47 Biosense Webster 37 C WARNING This is a controlled proprietary and...

Страница 74: ...OCOOL SF Biosense Webster 1 2 3 4 Biosense Webster 5 1 6 7 THERMOCOOL SF 8 9 2 10 THERMOCOOL SF 8 Fr 11 1 1 2 WARNING This is a controlled proprietary and confidential document Verify revision is curr...

Страница 75: ...50 15 14 2 C 15 16 15 20 15 5 10 80 50 35 120 120 17 a 1 2 b c a b d e WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un docum...

Страница 76: ...EBSTER INC Biosense Webster Inc 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 dere...

Страница 77: ...ERMOCOOL SF Biosense Webster z ruchom ko c wk i powi zane z nim akcesoria s przeznaczone do mapowania elektrofizjologicznego stymulacji i zapisu serca przy u yciu cewnika oraz w przypadku stosowania z...

Страница 78: ...m nie ma p cherzyk w powietrza P cherzyki powietrza w roztworze fizjologicznym do przep ukiwania mog powodowa zatory 20 Przemy cewnik i przewody p ucz ce heparynizowanym normalnym roztworem soli fizjo...

Страница 79: ...tarczeniem pr du o cz stotliwo ci radiowej nale y go naprawi 45 Dok adno pomiaru temperatury przez diagnostyczny ablacyjny cewnik THERMOCOOL SF Biosense Webster z ruchom ko c wk tak jak pomiar w tempe...

Страница 80: ...ego do z cza typu luer cewnika diagnostyczno ablacyjnego THERMOCOOL SF 8 Przep uka cewnik i rurki stosuj c standardow techniki aby wyp uka uwi zione p cherzyka powietrza oraz sprawdzi czy otwory iryga...

Страница 81: ...iwo ci radiowej nale y sprawdzi czy na wierzcho kowej elektrodzie kopu kowej nie znajduje si skrzeplina Aby usun skrzeplin je li wyst puje mo na u y zwil onej ja owym roztworem fizjologicznym ja owej...

Страница 82: ...WIEK SZCZEG LNE BEZPO REDNIE PRZYPADKOWE WYNIKOWE LUB INNE SZKODY WYNIKAJ CE Z PONOWNEGO U YCIA JAKIEGOKOLWIEK JAKICHKOLWIEK PRODUKTU W OZNACZONEGO YCH JAKO PRODUKT Y DO JEDNORAZOWEGO U YTKU LUB W PRZ...

Страница 83: ...mem nebo intrakardi ln m trombem proto e by kat tr mohl vyvolat vznik embolick sra eniny 3 U pacient s protetick mi chlopn mi proto e kat tr m e prot zu po kodit 4 V koron rn vaskulatu e kv li riziku...

Страница 84: ...v n kat tru je nutno prov d t s vyu it m skiaskopick ho za zen K zasouv n ani k vytahov n kat tru nepou vejte nep im enou s lu ani kdy naraz te na odpor Jeliko opleten hrot je pevn mus se postupovat o...

Страница 85: ...oduktu a balen NEPOU VEJTE po uplynut data exspirace Pou t do Toto za zen je baleno a sterilizov no pouze k jednor zov mu pou it Nepou vejte opakovan znovu nezpracov vejte ani nesterilizujte Opakovan...

Страница 86: ...u b hem v konu aby se zajistila odpov daj c irigace Pozn mka Zobrazen teplota p edstavuje pouze teplotu elektrody nikoliv teplotu tk n 16 Zahajte v kon p i 15 a 20 wattech Po 15 sekund ch lze zv it v...

Страница 87: ...3 Nesouvisej c se za zen m i v konem retence mo i p echodn necitlivost kon etin Parkinsonova choroba a gastrointestin ln divertikul za ODM TNUT Z RUK A OMEZEN ODPOV DNOSTI NA POPISOVAN PRODUKT PRODUKT...

Страница 88: ...r kiv lthatja egy v rr g k pz d s t 3 M sz vbillenty kkel rendelkez betegek eset ben a kat ter k ros thatja a m sz vbillenty ket 4 A koszor erekben mivel fenn ll a koszor art ri k s r l s nek kock zat...

Страница 89: ...rekvencia okozta sebek keletkez snek kock zata Ez rt gondosan meg kell fontolni az eszk z haszn lat t serd l kor el tti szakaszban l v gyermekekn l Tov bb nem tanulm nyozt k a t netmentes betegekn l f...

Страница 90: ...rekvenci s abl ci alkalmaz si param terei a abl ci helysz n t l az egyes elj r sokn l adott speci lis llapotokt l s a r di frekvenci s gener tor vez rl ramk r t l f ggenek Az el zetes llatk s rletek s...

Страница 91: ...nehezebben mozd that az elhajl si mechanizmus A be poz ci b l az ramutat j r s val ellent tes ir nyban elforgatva egyre laz bb k nnyebben kezelhet az elhajl si mechanizmus 2 bra 12 A r di frekvenci s...

Страница 92: ...elz r d s vasovagalis reakci k sz vperfor ci perikardi lis eff zi tampon d v rr g k l gemb lia aritmi k s sz vbillenty k rosod s l gmell s hemothorax t d d ma hipoxia mellh rtya eff zi akut l gz si di...

Страница 93: ...pr pade pacientov ktor sa v prech dzaj cich smich t d och podrobili ventrikulot mii alebo atriot mi preto e chirurgick z krok by mohol zv i riziko perfor cie 2 v pr pade pacientov s myx mom alebo intr...

Страница 94: ...cientov 25 Na predch dzanie tromboembolizmu pri vstupe do avej strany srdca pri abla n ch z krokoch sa pou va intraven zne hepar n Mnoho lek rov predpisuje na 3 mesiace po z kroku aspir n menej asto w...

Страница 95: ...frekven n ho gener tora V nasleduj cej asti N vod na pou vanie a v tabu ke 1 s uveden odpor an parametre vysokofrekven n ch aplik ci vych dzaj ce z dajov z skan ch zo t di na zvierat ch a u och Pri ka...

Страница 96: ...15 W a 30 W 31 W a 50 W Monitorovanie teploty 40 C 40 C Iriga n prietok po as aplik cie vysokofrekven nej energie 8 ml min 15 ml min Trvanie aplik cie 30 a 120 sek nd 60 a 120 sek nd Ak sa transmur l...

Страница 97: ...n ho srdcov ho defibril tora an mia trombocytop nia diseminovan intravaskul rna koagul cia epistaxa celkov infekcia infekcia mo ov ch ciest zastavenie d chania vyvolan upokojen m retencia CO2 vyvolan...

Страница 98: ...ali intrakardialnim trombusom saj lahko kateter povzro i nastanek krvnega strdka 3 Pri bolnikih z umetnimi zaklopkami saj lahko kateter po koduje protezo 4 Pri sr nem o ilju zaradi tveganja po kodova...

Страница 99: ...aciji 26 Kadar se diagnosti ni ablacijski kateter z upogibljivo konico Biosense Webster THERMOCOOL SF uporablja skupaj s konvencionalnimi sistemi z uporabo fluoroskopije za dolo anje polo aja konice k...

Страница 100: ...tra z upogibljivo konico THERMOCOOL SF sodijo BB DD FF JJ BD FJ DJ BF in DF Ve dodatkov za kateter so na voljo posebej Shranjevanje Diagnosti ni ablacijski kateter z vodljivo konico THERMOCOOL SF je t...

Страница 101: ...ergijo in to visoko stopnjo pretoka vzdr ujte e 5 sekund po kon anju dovajanja energije Za stopnje energije do 30 vatov se uporablja visoka stopnja pretoka 8ml min Za stopnje energije med 31 50 vati s...

Страница 102: ...rne arterije disekcija koronarne arterije sr na tromboembolija perikarditis perforacija tamponada srca po kodbe zaklopk in zvi ana raven fosfokinaze 3 Nepovezani s pripomo kom ali postopkom zastajanje...

Страница 103: ...J DJ BF DF CARTO EP THERMOCOOL SF Nav Biosense Webster THERMOCOOL SF 1 2 3 4 5 6 7 1 RF RF 2 3 4 5 WARNING This is a controlled proprietary and confidential document Verify revision is current prior t...

Страница 104: ...RF OFF OFF 10 V AV RF 11 RF 12 n phrenicus 13 14 15 16 17 18 19 20 21 22 Biosense Webster THERMOCOOL SF 23 THERMOCOOL SF 24 25 3 26 Biosense Webster THERMOCOOL SF 27 28 29 WARNING This is a controlled...

Страница 105: ...ebster THERMOCOOL SF 41 42 Biosense Webster THERMOCOOL SF 43 44 RF 45 Biosense Webster THERMOCOOL SF RF 46 47 RF RF RF Biosense Webster RF RF RF 37 C RF RF RF RF RF RF 1 THERMOCOOL SF WARNING This is...

Страница 106: ...COOL SF 1 2 3 4 RF Biosense Webster 5 1 U ml 6 7 THERMOCOOL SF 8 9 2 ml min 10 THERMOCOOL SF 8 F 11 1 1 2 off on off on WARNING This is a controlled proprietary and confidential document Verify revisi...

Страница 107: ...8 ml min 31 50 15 ml min 14 RF 2 C 15 16 15 20 15 5 10 W 80 50 W 35 W RF 120 120 17 RF a 1 2 ml b c d e 1 WARNING This is a controlled proprietary and confidential document Verify revision is current...

Страница 108: ...OSENSE 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...

Страница 109: ...diac Contraindica ii Nu utiliza i acest cateter 1 dac pacientul a suferit o ventriculotomie sau atriotomie n ultimele opt s pt m ni deoarece interven iile chirurgicale recente pot spori riscul de perf...

Страница 110: ...tea st ng a inimii n timpul abla iunii iar mul i medici prescriu aspirin mai rar warfarin timp de aproximativ 3 luni ulterior procedurii Nu exist nc un consens asupra necesit ii utiliz rii de agen i a...

Страница 111: ...abla iune Modul de livrare Cateterul THERMOCOOL SF cu v rf deflectabil pentru diagnosticare abla iune este livrat steril sterilizat cu oxid de etilen cu excep ia cazului n care ambalajul este deschis...

Страница 112: ...min Temperatura afi at pe generatorul de RF nu reprezint temperatura tisular sau temperatura interfe ei electrod esut Recomand ri suplimentare Pentru abla iunea flutterului dependent de istm aplicarea...

Страница 113: ...ar apnee indus prin sedare reten ie de CO2 indus prin sedare cu letargie i colecistit 2 Legate de RF dureri disconfort toracic tahiaritmie ventricular TIA CVA blocaj total al cordului spasm al arterei...

Страница 114: ...el juhtudel 1 kui patsiendil on olnud ventrikulotoomia v i atriotoomia eelnenud kaheksa n dala jooksul sest hiljutine operatsioon v ib suurendada perforatsiooni riski 2 kui patsiendil on m ksoom v i s...

Страница 115: ...ide juures 25 Trombembooliat v ltimiseks peaks kasutama juhul kui ablatsiooni ajal siseneti vasakusse s damepoolde intravenoosselt hepariini paljud arstid m ravad protseduurij rgselt kolmeks kuuks asp...

Страница 116: ...ri ja impedantsi n itude t usu Tarnimine THERMOCOOL SF diagnoosi ablatsiooni k rvalejuhitava tipuga kateeter on tarnimisel steriilne EtO kui pakend pole vigastatud ega avatud Praegu saadaval olevate T...

Страница 117: ...vatav temperatuur ei n ita koe temperatuuri ega elektroodi koeliidese temperatuuri T iendav soovitus Kitsendist s ltuva laperduse ablatsiooni korral tuleks v imsusi 30 50 W kasutada ainult siis kui ju...

Страница 118: ...tingitud CO2 retentsioon koos letargia ja kolets stiidiga 2 Seoses RF vooluga valu ebamugavus rinnus ventrikulaarne tahh ar tmia m duv ajuisheemia s dame veresoonte nnetusjuhtum t ielik s damehalvatus...

Страница 119: ...cijas risku 2 Ja pacientam ir miksoma vai intrakardi ls trombs jo katetrs var izrais t emboliju 3 Pacientiem ar v rstu u prot z m jo katetrs var saboj t prot zi 4 Koron rajos asinsvados jo past v kor...

Страница 120: ...gi lai izvair tos no sirds boj jumiem perfor cijas vai tampon des Katetra p rvieto ana ir j veic ar fluoroskopisko kontroli Ja saj tat pretest bu neizmantojiet p rlieku lielu sp ku lai pavirz tu katet...

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Страница 122: ...ijas pievad ana ir pabeigta Jaudai l dz 30 vatiem j lieto liels pl smas trums 8 ml min Jaudas l menim 31 50 W ir j lieto liels pl smas trums 15 ml min 14 RF ener ijas pievad anu nedr kst s kt pirms i...

Страница 123: ...koron ro art riju p rgrie ana sirds tromboembolija perikard ts sirds perfor cija tampon de v rstu u boj jumi un paaugstin ts fosfokin zes l menis 3 Bez saist bas ar ier ci vai proced ru ur na aizture...

Страница 124: ...rizik 2 Pacientams turintiems miksom arba intrakardialin tromb nes kateteris gali nusodinti embolus 3 Pacientams su vo tuv protezais nes kateteris gali sugadinti protez 4 Koronarin se kraujagysl se d...

Страница 125: ...abliacijos 26 Naudojant Biosense Webster THERMOCOOL SF diagnostin abliacin kateter lankstomu galiuku su prastin mis sistemomis fluoroskopijos naudojimas kateterio galiuko vietai nustatyti manipuliuot...

Страница 126: ...abliaciniams lankstaus galiuko kateteriams i linkimai BB DD FF JJ BD FJ DJ BF ir DF Papildomi kateterio pried taisai yra pateikiami atskirai Laikymas THERMOCOOL SF diagnostinis abliacijos kateteris la...

Страница 127: ...naudojant emesnius galingumo lygius ne manoma blokuoti laidumo 13 Rekomendacijos irigacijai 5 sekundes prie radijo da ni energijos padidinkite irigacij iki auk to tek jimo da nio lygmens 5 sekundes i...

Страница 128: ...mija tranzitorin i emin ataka TIA mus smegen kraujo apytakos sutrikimas CVA visi ka irdies blokada vainikini arterij spazmai vainikini arterij tromboz vainikini arterij disekcija tromboembolija perika...

Страница 129: ...the Management of Patients in Atrial Fibrillation Fuster V Ryden LE Cannom DS et al ACC AHA ESC 2006 Guidelines for the management of the patients with atrial fibrillation Circulation 2006 114 257 35...

Страница 130: ...Webster 33 Biosense Webster THERMOCOOL SF RF 34 35 36 Biosense Webster THERMOCOOL SF 37 38 MRI 39 X 40 Biosense Webster THERMOCOOL SF RF 41 42 Biosense Webster THERMOCOOL SF RF EMI 43 44 RF RF RF 45...

Страница 131: ...77 o F THERMOCOOL SF RF THERMOCOOL SF Biosense Webster 1 2 3 4 Biosense Webster RF 5 1 u ml 6 7 THERMOCOOL SF 8 9 2 ml 10 8F THERMOCOOL SF X 11 1 1 2 WARNING This is a controlled proprietary and conf...

Страница 132: ...0 15ml 14 RF 2 C 15 16 15 20 15 5 10 80 50 35 1 RF 120 120 RF 17 RF a 1 2 ml b c a b d e 1 ARDS ICD 2 RF 3 WARNING This is a controlled proprietary and confidential document Verify revision is current...

Страница 133: ...INC Biosense Webster Inc 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 134: ...f Patients in Atrial Fibrillation Fuster V Ryden LE Cannom DS et al ACC AHA ESC 2006 Guidelines for the management of the patients with atrial fibrillation Circulation 2006 114 257 354 7 8 40 9 ICD IC...

Страница 135: ...MOCOOL SF 37 38 MRI 39 X 40 Biosense Webster THERMOCOOL SF 41 42 Biosense Webster THERMOCOOL SF EMI 43 44 45 Biosense Webster THERMOCOOL SF 46 47 Biosense Webster 37 1 THERMOCOOL SF THERMOCOOL SF EtO...

Страница 136: ...1 2 2 12 1 1 15 W 30 W 31W 50 W 40 40 8ml min 15ml min 30 120 60 120 30 30 15ml min 30 50 13 5 5 30 8ml min 31 50 15ml min WARNING This is a controlled proprietary and confidential document Verify re...

Страница 137: ...CO2 2 TIA CVA 3 BIOSENSE WEBSTER BIOSENSE WEBSTER Biosense Webster WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es un document...

Страница 138: ...ines for the Management of Patients in Atrial Fibrillation Fuster V Ryden LE Cannom DS et al ACC AHA ESC 2006 Guidelines for the management of the patients with atrial fibrillation Circulation 2006 11...

Страница 139: ...MOCOOL SF RF Biosense Webster 33 Biosense Webster THERMOCOOL SF RF 34 35 36 Biosense Webster THERMOCOOL SF 37 38 MRI 39 40 RF Biosense Webster THERMOCOOL SF 41 42 RF Biosense Webster THERMOCOOL SF EMI...

Страница 140: ...HERMOCOOL SF 5 25o C 41 77 o F RF THERMOCOOL SF Biosense Webster THERMOCOOL SF 1 2 3 4 Biosense Webster RF 5 1 u ml 6 7 THERMOCOOL SF Luer 8 9 2ml 10 THERMOCOOL SF 8 F 11 1 1 WARNING This is a control...

Страница 141: ...ml 14 RF 2 C 15 16 15 20 15 transmural 5 10 80 35 50 RF 120 120 RF 17 RF a 1ml 2ml b c a b d e 1 AV ARDS ICD CO2 WARNING This is a controlled proprietary and confidential document Verify revision is c...

Страница 142: ...E WEBSTER INC Biosense Webster Inc 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 d...

Страница 143: ...ement of Patients in Atrial Fibrillation Fuster V Ryden LE Cannom DS et al ACC AHA ESC 2006 Guidelines for the management of the patients with atrial fibrillation Circulation 2006 114 257 354 7 8 40 9...

Страница 144: ...40 Biosense Webster THERMOCOOL SF RF 41 42 Biosense Webster THERMOCOOL SF RF EMI 43 44 RF RF RF RF 45 Biosense Webster THERMOCOOL SF RF RF 46 47 RF RF RF Biosense Webster RF RF RF RF 37 RF RF RF RF RF...

Страница 145: ...2 12 RF 1 1 RF RF 15 W 30 W 31W 50 W 40 C 40 C RF 8ml 15ml 30 120 60 120 30 30 15ml RF 30 50 13 RF 5 5 30 8ml 31 50 15ml 14 2 C RF 15 WARNING This is a controlled proprietary and confidential documen...

Страница 146: ...2 RF TIA CVA 3 BIOSENSE WEBSTER INC BIOSENSE WEBSTER INC Biosense Webster Inc WARNING This is a controlled proprietary and confidential document Verify revision is current prior to use AVISO Este es...

Страница 147: ...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 148: ...s 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...

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