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INSTRUCTIONS FOR USE
Suggested Instructions for Use
Evolution RL Controlled-Rotation Dilator Sheath Set

WARNING: When using dilator sheaths or sheath sets do not insert more than one sheath set into a

vein at a time. Severe vessel damage, including venous wall laceration requiring surgical repair, may

occur.

SUPERIOR APPROACH

1. Surgically expose the proximal end of the indwelling catheter/lead and remove the catheter/lead from its

connections (if connected). Remove all suture and tie-down materials.

2. Cut off all proximal fittings, if present, using clippers or other cutters. It is important to cut the catheter/

lead very close to the connector (but past any crimp joints) leaving as long a portion of the indwelling

catheter/lead to work with as possible. Avoid closing off the interior lumen (or coil) of the catheter/lead

when cutting it.

3. Consider passing a Locking Stylet through the inner lumen of the catheter/lead to stabilize the catheter/

lead during dilation of surrounding tissues. Closely follow the “Suggested Instructions for Use” for the

Locking Stylet to:

A. Expose the inner coil of the catheter/lead
B. Check patency of the coil lumen
C. Determine the appropriate size of Locking Stylet based on the inner diameter of the catheter/lead
D. Advance the Locking Stylet to the distal end of the catheter/lead
E. Lock the Locking Stylet in place

4. Unless the catheter/lead insulation is damaged, degraded or too thin, tie a ligature or use a compression

coil (Cook) at the proximal end of the catheter/lead, compressing the insulation against the coil and Locking

Stylet to help prevent the coil and insulation from stretching. The ligature can be tied to the loop handle or

to the suture tie loop.

NOTE: If a Locking Stylet has not been used, be aware that damage to the catheter/lead caused by

pulling on it may prevent subsequent passage of a Locking Stylet through the lumen and/or make

dilation of scar tissue more difficult.

5. For an active fixation catheter/lead, attempt to unscrew the catheter/lead by rotating the catheter/lead

and Locking Stylet counterclockwise if appropriate.

6. Gently pull back on the catheter/lead to see if it is still engaged in tissue. If the catheter/lead is sufficiently

loose in the tissue, gently pull on the Locking Stylet and catheter/lead to remove it.

NOTE: If removing a chronic pacing lead, be aware that if it is freed spontaneously during the extraction

procedure, the lead tip may become trapped in the upper vasculature. Dilator sheaths, advanced at least

to the innominate vein, are often necessary to extract the lead tip through the scar tissue at the site of

venous entry, and to avoid a venotomy.

7. If the catheter/lead is not removed from the vessel with gentle pulling then using dilator sheaths,

including the Evolution or Evolution RL Controlled-Rotation Dilator Sheath Set may help separate the

catheter/lead from tissue encapsulation.

8. With the inner Evolution RL Controlled-Rotation Dilator Sheath placed inside the appropriate outer

sheath for telescopic action, insert the proximal free end of the catheter/lead with Locking Stylet in place,

into the distal end of the inner Evolution RL Controlled-Rotation Dilator Sheath. Advance the catheter/lead

with Locking Stylet, until it completely exits the opposite (proximal) end of the sheath set.

9. Apply adequate retracting pressure or tension on the catheter/lead via its Locking Stylet.

This is critical

to safe passage of the sheath set over the catheter/lead. If tension is inadequate, the catheter/lead

may buckle, precluding the sheath set from advancement along the appropriate path.

10. With the catheter/lead in tension, and under fluoroscopic guidance, advance the inner sheath along the

length of the catheter/lead and into the blood vessel. Rotate the inner Evolution® RL Controlled-Rotation

Dilator Sheath, by squeezing and releasing the trigger activation handle.

For Bi-Rotational motion

Squeeze trigger to activate sheath rotation. A return of the trigger to its forward most position will

mechanically change the rotational direction of the sheath to the direction opposite of the last rotation.

Repeat as appropriate.

For Uni-Rotational motion

Squeeze trigger to activate sheath rotation and repeat without allowing trigger to return to its forward

most position. Repeat as appropriate.

Advance the outer sheath over the inner sheath, keeping it within the vessel.

Содержание Evolution RL

Страница 1: ...forgat s dilat torh vely k szlet Haszn lati utas t s Set di guaine dilatatrici a rotazione controllata Evolution RL Istruzioni per l uso Evolution RL kontroliuojamojo sukimo pl tiklio vamzdeli rinkiny...

Страница 2: ...lead Severe vessel or endocardial wall damage may result from the stiffened catheter lead or from fracture or migration of the abandoned stylet wire Do not apply weighted traction to an inserted Locki...

Страница 3: ...n Dilator Sheath Set or Byrd Telescoping Stainless Steel Dilator Sheath Set should be used only to minimally enter the vessel Be aware that insertion of a stainless steel dilator sheath over a Byrd Di...

Страница 4: ...ate 6 Gently pull back on the catheter lead to see if it is still engaged in tissue If the catheter lead is sufficiently loose in the tissue gently pull on the Locking Stylet and catheter lead to remo...

Страница 5: ...ep the outer sheath s beveled tip if applicable to the inside radius of the bend 12 For cardiac leads if the lead has not been freed by the time the sheaths near the myocardium position the outer shea...

Страница 6: ...tem uvnit katetru vodi e P soben m vyztu en ho katetru vodi e p padn zlomen m nebo migrac ponechan ho stiletov ho dr tu m e doj t k z va n mu poran n c vy nebo endokardi ln st ny Neaplikujte trakci se...

Страница 7: ...enou rotac Evolution Shortie RL nebo teleskopick souprava dilata n ch sheath z nerezov oceli Byrd mus b t pou ita tak aby jej vstup do c vy byl pouze minim ln M jte na pam ti e zaveden dilata n ho she...

Страница 8: ...vodi e a uzamykac ho stiletu proti sm ru hodinov ch ru i ek je li t eba 6 Jemn zat hn te zp t katetr vodi abyste zjistili zda je st le zapu t n do tk n Pokud je katetr vodi ve tk ni dostate n voln jem...

Страница 9: ...it u vnit n ho polom ru ohybu 12 Pokud u kardi ln ch vodi nedo lo k uvoln n vodi e do okam iku p ibl en sheath k myokardu um st te vn j sheath tak aby tup konec sm oval k myokardu St hn te vnit n she...

Страница 10: ...st alvorlig skade p kar eller endokardial v g fra det afstivede kateter afledning eller fra brud eller migration af den efterladte stiletwire P f r ikke v gtet traktion p en indf rt l sestilet da det...

Страница 11: ...t af rustfrit st l m kun anvendes til at skaffe minimal adgang til karret V r opm rksom p at inds tning af en dilatatorsheath af rustfrit st l hen over et Byrd sheath af polypropylen Evolution eller...

Страница 12: ...igtigt katetret afledningen tilbage for at se om den stadig sidder fast i v vet Hvis katetret afledningen sidder tilstr kkeligt l st i v vet tr kkes der forsigtigt i l sestiletten og katetret aflednin...

Страница 13: ...evant holdes ind imod afb jningens inderside 12 For afledninger til hjertet g lder det at hvis afledningen ikke er frigjort n r sheaths er n r myokardiet skal den ydre sheath placeres s ledes at den a...

Страница 14: ...steifte Katheter bzw die versteifte Elektrode oder ein gerissener bzw verschobener im K rper belassener Mandrindraht kann eine schwere Gef wand oder Endokardverletzung verursachen Auf den eingesetzten...

Страница 15: ...volution Shortie RL Dilatatorschleusen Set mit kontrollierter Rotation oder das Teleskopartige Byrd Dilatatorschleusen Set aus Edelstahl darf nur so weit wie unbedingt notwendig in das Gef eingef hrt...

Страница 16: ...rschlinge befestigt werden HINWEIS Wenn der Sperrmandrin nicht verwendet wird muss beachtet werden dass eine Sch digung des Katheters der Elektrode durch Ziehen ein sp teres Durchschieben des Sperrman...

Страница 17: ...er zur Elektrode im Gef liegen um die Kr mmung der Schleuse beim Vorschieben zu minimieren Wird die innere Evolution RL Dilatatorschleuse mit kontrollierter Rotation w hrend des Vorschiebens mithilfe...

Страница 18: ...18 Evolution RL Evolution RL Evolution RL 9 Fr LR EVN 9 0 RL 11 Fr LR EVN 11 0 RL 13 Fr LR EVN 13 0 RL Evolution RL Cook J J LEAD EXTRACTION...

Страница 19: ...19 Evolution Evolution RL Evolution Evolution RL Evolution Shortie RL Byrd Byrd Evolution Evolution RL Evolution Evolution RL Evolution Evolution RL...

Страница 20: ...20 Evolution RL 1 2 3 A B C D E 4 Cook 5 6 7 Evolution Evolution RL 8 Evolution RL Evolution RL...

Страница 21: ...21 9 10 Evolution RL 11 4 cm Evolution RL 12 13 14 Evolution Evolution RL...

Страница 22: ...ra o migraci n de la gu a estilete abandonada pueden producir lesiones graves en los vasos o en la pared endoc rdica No aplique tracci n con contrapeso a un estilete de fijaci n introducido ya que pod...

Страница 23: ...Shortie RL o el equipo de vainas dilatadoras de acero inoxidable telesc picas Byrd solo deben utilizarse para acceder al vaso en el grado m nimo necesario Tenga en cuenta que la introducci n de una v...

Страница 24: ...de ligadura de sutura NOTA Si no se ha utilizado un estilete de fijaci n tenga en cuenta que los da os que pueda sufrir el cat ter cable al tirar de l pueden impedir el posterior paso de un estilete...

Страница 25: ...atura de la vaina durante el avance Girar la vaina dilatadora de giro controlado Evolution RL interior utilizando el mango de disparo de activaci n y la vaina exterior durante el avance puede facilita...

Страница 26: ...on une l sion grave du vaisseau ou de la paroi endocardique risque de se produire en raison du raidissement du cath ter sonde ou de la rupture ou la migration du stylet laiss en place Ne pas exercer u...

Страница 27: ...ilatation rotation contr l e Evolution Shortie RL ou le set de gaines de dilatation t lescopiques de Byrd en acier inoxydable doivent tre utilis s uniquement pour la p n tration mini invasive du vaiss...

Страница 28: ...ue l endommagement par traction du cath ter sonde peut emp cher le passage ult rieur d un stylet de verrouillage par la lumi re et ou compliquer la dilatation du tissu cicatriciel 5 Pour un cath ter s...

Страница 29: ...er sonde dans le vaisseau et r duire au minimum la courbure de gaine pendant l avancement La rotation de la gaine interne de dilatation rotation contr l e Evolution RL l aide de la poign e d activatio...

Страница 30: ...egben hagyott mandrindr t t r se vagy elv ndorl sa az rfal vagy a sz vbelh rtya s lyos k rosod s t okozhatja A felvezetett r gz thet mandrint nem szabad s llyal h zni mert ez a sz vizom kit p d s t al...

Страница 31: ...t torh vely k szletet vagy a Byrd teleszk pos rozsdamentes ac l dilat torh vely k szletet csak az rbe val minim lis behatol sra szabad haszn lni Ne felejtse hogy rozsdamentes ac l dilat torh velynek a...

Страница 32: ...JEGYZ S Ha nem haszn lt r gz thet mandrint ne felejtse hogy a kat ternek vezet knek h z ssal okozott k rosod s meghi s thatja a r gz thet mandrin k s bbi thalad s t a lumenen s vagy megnehez theti a h...

Страница 33: ...e hogy a h velyeket egy vonalban tudja tartani az rben l v kat terrel vezet kkel s az el retol s sor n a h vely g rb l se minim lis legyen A bels Evolution RL kontroll lt forgat s dilat torh vely k sz...

Страница 34: ...la frattura o migrazione del mandrino abbandonato possono provocare gravi danni alla parete del vaso o alla parete endocardica Per evitare avulsione miocardica ipotensione o lacerazione della parete...

Страница 35: ...a rotazione controllata Evolution Shortie RL o il set di guaine dilatatrici telescopiche in acciaio inossidabile Byrd devono essere usati esclusivamente per ottenere un accesso minimo al vaso Tenere p...

Страница 36: ...mandrino bloccante tenere presente che gli eventuali danni subiti dal catetere elettrocatetere a causa della trazione ad esso applicata possono impedire il successivo inserimento di un mandrino blocca...

Страница 37: ...er ridurre al minimo la curvatura della guaina durante l avanzamento La rotazione della guaina dilatatrice a rotazione controllata Evolution RL interna mediante l impugnatura di azionamento a grillett...

Страница 38: ...o k ne kol kateterio ar elektrodo viduje teb ra statytas fiksuojamasis stiletas Sustandintas kateteris ar elektrodas arba l usi ar i vietos pajud jusi palikta stileto viela gali sunkiai su aloti krauj...

Страница 39: ...rurginiai si lai ir perri imo ligat r med iagos Evolution Shortie RL kontroliuojamojo sukimo pl tiklio vamzdeli rinkin arba Byrd ner dijan iojo plieno teleskopinio pl tiklio vamzdeli rinkin galima tik...

Страница 40: ...prie laikrod io rodykl jei galima 6 Kateter ar elektrod velniai patraukite atgal patikrindami ar jis teb ra sukib s su audiniais Jei kateteris ar elektrodas pakankamai atsilaisvin s nuo aplinkini audi...

Страница 41: ...nuo amb galiuk jei taikoma i laikykite palei vidin i linkio spindul 12 irdies elektrod atveju jei elektrodas n ra i laisvintas iki to laiko kai vamzdeliai priart ja prie miokardo i orin vamzdel nusta...

Страница 42: ...geleidingsdraad of breuk of migratie van de achtergebleven stiletdraad ernstig vaatletsel of beschadiging van de endocardiale wand veroorzaken Oefen geen zware trekkracht uit op een ingebracht vergren...

Страница 43: ...erialen zijn verwijderd De Evolution Shortie RL dilatatorsheathset met rotatieregeling of de Byrd telescopische roestvrijstalen dilatatorsheathset mag uitsluitend worden gebruikt voor minimale intrede...

Страница 44: ...ebruikt is denk er dan aan dat de katheter geleidingsdraad beschadigd kan raken als eraan wordt getrokken en dat daardoor het alsnog inbrengen van een vergrendelstilet door het lumen niet meer mogelij...

Страница 45: ...eaths in lijn te houden met de katheter geleidingsdraad in het bloedvat en het buigen van de sheath tijdens het opvoeren tot een minimum te beperken Door tijdens het opvoeren de binnenste Evolution RL...

Страница 46: ...ede kateteret den avstivede avledningen eller fra brudd eller migrasjon av den etterlatte stilettvaieren Ikke p f r vektet traksjon p en innf rt l sestilett da dette kan f re til myokardial avrivning...

Страница 47: ...pisk dilatatorhylsesett i rustfritt st l m kun anvendes for skaffe minimal adgang til karet V r oppmerksom p at innf ringen av et dilatatorhylsesett i rustfritt st l over et Byrd dilatatorhylsesett i...

Страница 48: ...vis en l sestilett ikke er blitt brukt v r oppmerksom p at hvis katetret avledningen skades under trekking kan dette forhindre etterf lgende passasje av en l sestilett gjennom lumenen og eller gj re d...

Страница 49: ...vinkelen slik at hylsene rettes inn med katetret avledningen i karet og for minske kurvatur av hylsen under fremf ring Rotasjon av den indre Evolution RL dilatatorhylsen med kontrollert rotasjon vha u...

Страница 50: ...enie lub z amanie lub przemieszczenie si pozostawionego bez nadzoru drutu mandrynu mo e spowodowa powa ne uszkodzenie ciany naczynia lub wsierdzia Wprowadzonego mandrynu blokuj cego nie wolno poddawa...

Страница 51: ...mocuj cych Zestaw koszulek rozszerzaj cych Evolution Shortie RL z regulacj obrotu lub zestaw teleskopowych koszulek rozszerzaj cych Byrd ze stali nierdzewnej nale y stosowa wy cznie do uzyskania mini...

Страница 52: ...uchwytu p tli lub do p tli wi zania szwu UWAGA Je li nie u yto mandrynu blokuj cego nale y pami ta e uszkodzenie cewnika odprowadzenia spowodowane poci ganiem go mo e uniemo liwi p niejsze przeprowadz...

Страница 53: ...czasie wsuwania Obracanie zestawem wewn trznej koszulki rozszerzaj cej Evolution RL z regulacj obrotu przy u yciu spustowego uchwytu uruchamiaj cego i jego zewn trznej koszulki podczas wsuwania zesta...

Страница 54: ...te de fixa o A presen a de um cateter ou el ctrodo r gidos e a fractura ou migra o de um fio de estilete abandonado podem provocar les es na parede do endoc rdio ou les es vasculares graves N o aplica...

Страница 55: ...bainhas de dilata o telesc picas em a o inoxid vel Byrd deve ser utilizado apenas para um acesso m nimo ao vaso De salientar que a inser o de uma bainha de dilata o em a o inoxid vel sobre um conjunt...

Страница 56: ...sado um estilete de fixa o tenha aten o aos danos no cateter ou el ctrodo provocados quando s o puxados uma vez que poder o impedir a passagem subsequente de um estilete de fixa o atrav s do l men e o...

Страница 57: ...da bainha durante a sua progress o A rota o da bainha interna de dilata o de rota o controlada Evolution RL utilizando o punho accionador e a bainha externa durante o avan o pode facilitar a progress...

Страница 58: ...58 Evolution RL Evolution RL Evolution RL 9 Fr LR EVN 9 0 RL 11 Fr LR EVN 11 0 RL 13 Fr LR EVN 13 0 RL Evolution RL Cook J J LEAD EXTRACTION...

Страница 59: ...59 Evolution Evolution RL Evolution Evolution RL Evolution Shortie RL Byrd Byrd Evolution Evolution RL Evolution Evolution RL Evolution Evolution RL...

Страница 60: ...60 Evolution RL 1 2 3 A B C D E 4 Cook 5 6 7 Evolution Evolution RL 8 Evolution RL Evolution RL...

Страница 61: ...61 9 10 Evolution RL 11 4 Evolution RL 12 13 14 Evolution Evolution RL...

Страница 62: ...fr n katetern elektroden som blivit styv eller fr n frakturering eller migration av den kvarl mnade mandr ngledaren Till mpa inte viktad traktion p en inf rd l smandr ng eftersom avulsio i myokardiet...

Страница 63: ...ll eller Byrd teleskopiskt dilatatorhylsset i rostfritt st l b r endast f ras in s lite som m jligt i k rlet T nk p att om en dilatatorhylsa i rostfritt st l f rs in ver en Byrd dilatatorhylsset i pol...

Страница 64: ...l mpligt 6 Dra f rsiktigt katetern elektroden bak t f r att se om den fortfarande sitter fast i v vnad Om katetern elektroden sitter tillr ckligt l st i v vnaden dra f rsiktigt i l smandr ngen och ka...

Страница 65: ...tetern ska ytterhylsans avfasade spets om till mpligt h llas i innerradien av b jningen 12 F r hj rtelektroder g ller att om elektroden inte har frigjorts n r hylsorna b rjar n rma sig myokardiet ska...

Страница 66: ...66...

Страница 67: ...67...

Страница 68: ...r EC Representative COOK VANDERGRIFT INC COOK MEDICAL EUROPE LTD 1186 Montgomery Lane O Halloran Road Vandergrift PA 15690 U S A National Technology Park Limerick Ireland www cookmedical com COOK 2019...

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