Johnson & Johnson Biosense Webster ThermoCool Скачать руководство пользователя страница 146

Страница: 146 / 148

繁體中文

146 M-5276-658A

16.

以

15-20

瓦的功率開始手術。

秒之後，功率可根據需要以

5-10 W

的增幅

遞增，直至達到透壁燒灼，

單極心房電圖振幅減小超過

80%

或者出現等振

幅和低振幅雙電位即說明達到了透壁燒灼。建議在導管與組織平行時，功率
不要超過

50 W

，而當導管與組織成直角時，功率不要超過

35 W

。每次

消融術的持續時間不應超過

120

秒。在這

120

秒的能量施加期間，允許將導

管移到下一個部位。可使用同一根導管將

電流再次施加到相同的或另外

的部位。

17.

如果發生器被關斷（由於阻抗或溫度原因），則必須將導管退出並檢查尖端
電極上的凝固物之後才能再次施加

電流。為了清除凝固物（若有），可

用無菌生理鹽水浸濕的無菌紗布輕輕將端頭部分擦拭乾淨，請勿用力擦洗或
扭曲尖端電極，否則會損壞尖端電極的黏接並導致尖端電極鬆脫。重新插入
導管之前，請確保灌注孔未被封住，具體做法如下：

往一支

到

2 ml

注射器

內注入生理鹽水，然後將注射器安裝到灌注管末

端的閥門上。

小心謹慎地將生理鹽水從注射器注入導管中。此時應能從導管尖端觀察到
均勻的液流。

必要時，請重複步驟

和

。

按照標準技術要求對導管和灌注管進行沖洗，以確保沒有殘留的氣泡，並
確認灌注孔通暢。

這時，即可給患者插入導管。

警告：如果導管仍然堵著或無法正常工作，請勿繼續使用此導管。

注：小的注射器可提供足夠的壓力，以產生顯著的液流。

不良反應

導管消融術曾造成的嚴重不良反應包括：肺栓塞、心肌梗塞、中風、心包填塞及
死亡。

下列並發症曾在前期研究過程中出現或在文獻中有報道：

與導管插入術／導管操作有關：血管出血

局部血腫、血栓形成、房室瘻、假性

動脈瘤、血栓栓塞、血管迷走神經反應、心臟穿孔、心包積液／心包填塞、

血栓症、空氣栓塞、心律不齊及瓣膜損傷、氣胸及胸腔積血、肺水腫、組織缺
氧、胸膜腔積液、急性呼吸窘迫綜合症（

ARDS

）、充血性心力衰竭、吸入性

肺炎、肺炎、氣喘發作、低血壓、

ICD

電極故障、貧血、血小板減少、彌散性

血管內凝血、鼻衄、全身感染、尿道感染、鎮靜藥物誘發的呼吸暫停、鎮靜藥
物誘發的

瀦留並伴有嗜睡和膽囊炎。

與

有關：胸痛

不適、心室性頻脈心律不整、

TIA

、

CVA

、完全心傳導阻

滯、冠狀動脈痙攣、冠狀動脈血栓形成、冠狀動脈剝離、心肌血栓性栓塞、

心包炎、心臟穿孔

心包填塞、瓣膜損傷以及磷酸激酶濃度上升。

與器械或手術無關：尿瀦留、暫態四肢麻木、帕金森病和胃腸憩室病。

品質擔保和責任限制免責聲明

對於本文說明的產品，本公司不提供任何明確或隱含擔保，包括但不限於任何隱
含的、針對特定用途的適售性或適合性的擔保。除特定法律有明確規定的以外，
否則在任何情況下

BIOSENSE WEBSTER, INC.

及其附屬公司均不對任何特殊、

直接、意外、間接或其他損壞承擔責任。

在不限制前述條款的情況下，

BIOSENSE WEBSTER, INC.

或其附屬公司均不對

因重複使用任何標有「單次使用」的產品或者適用法律禁止重複使用的產品而產
生的特殊、直接、意外、間接或其他損壞承擔責任。

出現在

Biosense Webster, Inc.

印刷物（包括本出版物）上的說明和規格僅用於提

供資訊，只能作為產品在製造時的一般說明，不能構成或作為所指產品的擔保。

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

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...

Страница 121: ...rat rai ir j b t starp 5 un 25 o C 41 un 77 o F Steriliz cija Izlietot l dz datums is katetrs ir steriliz ts ar g zveida etil noks du Produkta un iepakojuma testi atbalsta termi u kas uzr d ts k Izlie...

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...

Результаты поиска

Содержание Biosense Webster ThermoCool

Отзывы:

Похожие инструкции для Biosense Webster ThermoCool

Бренды по названию

Популярные бренды

Johnson & Johnson Biosense Webster ThermoCool, Инструкция по эксплуатации

Результаты поиска

Содержание Biosense Webster ThermoCool

Отзывы:

Похожие инструкции для Biosense Webster ThermoCool

Бренды по названию

Популярные бренды