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SUGGESTED INSTRUCTIONS FOR USE
Evolution® Shortie 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.
WARNING: Do not attempt to negotiate the Evolution® Shortie RL Controlled-Rotation Dilator Sheath

Set

past a bend in the vessel as vessel wall or cardiac lead insulation damage may occur.

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® Shortie RL Controlled-Rotation Dilator Sheath Set may help separate the catheter/

lead from tissue encapsulation.

8. With the inner Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set placed inside the appropriate

outer sheath for telescopic action, insert the proximal free end of the catheter/lead into the distal end of

the inner Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set. Advance the catheter/lead until it

completely exits the opposite (proximal) end of the sheath set.

9. Apply adequate retracting pressure or tension on the catheter/lead and 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.

Содержание Evolution Shortie RL

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

Страница 2: ...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 Locking Stylet as myocardial avulsion h...

Страница 3: ...lled Rotation Dilator Sheath Set it is essential to carefully inspect the extravascular catheter lead tract to ensure removal of all suture sleeves sutures and tie down materials When advancing sheath...

Страница 4: ...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 pull...

Страница 5: ...essel has been achieved or fluoroscopic monitoring confirms that a mid clavicular location along the cardiac lead has been reached Exchange the Evolution Shortie RL Controlled Rotation Dilator Sheath...

Страница 6: ...nebo m e doj t k poran n st ny c vy nebo po kozen izolace endokardi ln ho vodi e P i pou v n dilata n ch sheath nebo souprav sheath nezav d jte do ly v ce ne jednu soupravu sheath najednou M e doj t k...

Страница 7: ...ixa n ch vodi o ek a p davn ch za zen POSTUP P i VE KER manipulaci s katetrem vodi em a se sheathem pou vejte skiaskopick zobrazen Trvale monitorujte EKG a arteri ln krevn tlak po celou dobu v konu a...

Страница 8: ...ktivn ho fixa n ho katetru vodi e se pokuste od roubovat katetr vodi rotac katetru vodi e a uzamykac ho stiletu proti sm ru hodinov ch ru i ek 6 Jemn zat hn te zp t katetr vodi abyste zjistili zda je...

Страница 9: ...kud pou v te soupravu dilata n ho sheathu Evolution Shortie RL s ovl d n m rotace v dob kdy byl ov en minim ln vstup do c vy nahra te ji jinou soupravou dilata n ho sheathu Evolution RL s ovl d n m ro...

Страница 10: ...eller isoleringen p den kardiale afledning N r dilatatorsheaths eller sheaths t bruges m der ikke indf res mere end t sheaths t i en vene ad gangen Det kan medf re alvorlig skade p kar inklusive rift...

Страница 11: ...ALLE manipulationer af kateter afledning og sheath Overv g kontinuerligt EKG og blodtryk under hele proceduren og under helbredelsen Hvis der anvendes sheaths eller sheaths t herunder Evolution Shorti...

Страница 12: ...uren kan bindes til l kkeh ndtaget eller til l kken til suturens binding BEM RK Hvis der ikke er brugt en l sestilet skal man v re opm rksom p at hvis katetret afledningen beskadiges under tr kning ka...

Страница 13: ...kar eller fluoroskopisk monitorering beviser at man har n et en medioklavikul r placering langs med hjerteafledningen Udskift Evolution Shortie RL dilatatorsheaths ttet med kontrolleret rotation med...

Страница 14: ...Elektrode f hren kann Beim Einsatz von Dilatatorschleusen oder Schleusensets darf nie mehr als ein Schleusenset gleichzeitig in eine Vene eingef hrt werden Andernfalls kann es zu einer schweren Gef v...

Страница 15: ...ktrodenverl ngerung Mandrine zum Aufschrauben aktiver Fixierelektroden Schlingen und weiterem Zubeh r bereithalten EINGRIFF ALLE Katheter Elektroden und Schleusenmanipulationen m ssen unter Durchleuch...

Страница 16: ...ge die Katheter Elektrodenisolierung nicht besch digt abgenutzt oder zu d nn ist eine Ligatur oder eine Kompressionsspirale Cook am proximalen Ende des Katheters der Elektrode anbringen Dabei die Isol...

Страница 17: ...l segriff in die vorderste Position zur ckkehren zu lassen Den Vorgang nach Bedarf wiederholen 11 Den Gebrauch des Instruments sofort einstellen sobald entweder ein minimaler Eintritt ins Gef erzielt...

Страница 18: ...18 Evolution Shortie RL Evolution Shortie RL Evolution Shortie RL 9 Fr LR EVN SH 9 0 RL 11 Fr LR EVN SH 11 0 RL Evolution Shortie RL Cook Evolution Shortie RL Evolution Shortie RL J J...

Страница 19: ...19 Evolution Shortie RL Evolution Shortie RL LEAD EXTRACTION Evolution Shortie RL Evolution Shortie RL Evolution Shortie RL...

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

Страница 21: ...8 Evolution Shortie RL Evolution Shortie RL 9 10 Evolution Shortie RL Evolution Shortie RL 11 Evolution Shortie RL Evolution RL Evolution Shortie RL Evolution Shortie RL Evolution Shortie RL Evolution...

Страница 22: ...islante del cable de derivaci n card aca Al utilizar vainas dilatadoras o equipos de vainas dilatadoras no introduzca m s de un equipo de vainas en una vena al mismo tiempo Podr an producirse lesiones...

Страница 23: ...iar PROCEDIMIENTO Utilice gu a fluorosc pica durante TODAS las manipulaciones del cat ter cable y de la vaina Vigile continuamente el ECG y la tensi n arterial durante todo el procedimiento y durante...

Страница 24: ...i n para ayudar a evitar el estiramiento de la espiral y del revestimiento aislante La ligadura puede atarse al mango de lazo o al lazo de ligadura de sutura NOTA Si no se ha utilizado un estilete de...

Страница 25: ...aso o cuando la monitorizaci n fluorosc pica confirme que se ha llegado a una posici n medioclavicular a lo largo del cable de derivaci n card aca Sustituya el equipo de vainas dilatadoras de rotaci n...

Страница 26: ...tant une r paration chirurgicale risque de se produire Lors de l utilisation d un stylet de verrouillage Ne pas laisser en place un cath ter sonde contenant un stylet de verrouillage dans un site anat...

Страница 27: ...la phase de r veil Si des gaines ou des sets de gaines sont utilis s notamment le set de gaines de dilatation Evolution Shortie RL rotation contr l e les pr cautions suivantes doivent tre suivies Ava...

Страница 28: ...et de l isolation La ligature peut tre fix e la poign e boucle ou la boucle servant attacher la suture REMARQUE Si un stylet de verrouillage n a pas t utilis noter que l endommagement par traction du...

Страница 29: ...e contr le radioscopique confirme qu un emplacement m dio claviculaire est atteint le long de la sonde cardiaque selon la premi re occurrence Remplacer le set de gaines de dilatation Evolution Shortie...

Страница 30: ...nafals r l s is t rt nhet R gz thet mandrin haszn latakor Ne hagyjon olyan kat tert vezet ket a betegben amelyikben m g benne van a r gz thet mandrin A merev tett kat ter vezet k vagy a betegben hagyo...

Страница 31: ...et vagy h velyk szleteket haszn l bele rtve az Evolution Shortie RL kontroll lt forgat s dilat torh vely k szletet is a k vetkez vint zked seket kell megtenni H velyek k z tt k az Evolution Shortie RL...

Страница 32: ...elforgat s val kicsavarni a kat tert vezet ket adott esetben 6 vatosan h zza vissza a kat tert vezet ket hogy rz kelje ssze van e m g kapcsol dva a sz vettel Ha a kat ter vezet k m r el gg laz n feksz...

Страница 33: ...zabad haszn lni MEGJEGYZ S Ha Evolution Shortie RL kontroll lt forgat s dilat torh vely k szletet haszn l az rbe val minim lis behatol s igazol sa ut n cser lje az Evolution Shortie RL kontroll lt for...

Страница 34: ...guente necessit di riparazione chirurgica Per l uso di un mandrino bloccante Non lasciare mai nel paziente un catetere elettrocatetere con il mandrino bloccante ancora al suo interno Il catetere elett...

Страница 35: ...erruzioni l ECG e la pressione arteriosa Durante l uso di guaine o di set con guaine incluso il set di guaine dilatatrici a rotazione controllata Evolution Shortie RL necessario rispettare le seguenti...

Страница 36: ...l anello dell impugnatura o all apposito anello per la fissazione della sutura NOTA Se non stato usato un mandrino bloccante tenere presente che gli eventuali danni subiti dal catetere elettrocatetere...

Страница 37: ...vazione fluoroscopica conferma che il dispositivo ha raggiunto una posizione medio clavicolare lungo l elettrocatetere a seconda di quale delle due si verifica per prima Sostituire il set di guaine di...

Страница 38: ...statytas fiksuojamasis stiletas Sustandintas kateteris ar elektrodas arba l usi ar i vietos pajud jusi palikta stileto viela gali sunkiai su aloti kraujagysl arba endokardo sienel Stipriai netempkite...

Страница 39: ...rie naudojant vamzdelius skaitant Evolution Shortie RL kontroliuojamojo sukimo pl tiklio vamzdeli rinkin kriti kai svarbu kruop iai patikrinti kateterio ar elektrodo trakto ekstravaskulin dal sitikina...

Страница 40: ...jam j stilet sukdami 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...

Страница 41: ...ion Shortie RL kontroliuojamojo sukimo pl tiklio vamzdeli rinkinys patvirtinus minimal patekim kraujagysl Evolution Shortie RL kontroliuojamojo sukimo pl tiklio vamzdeli rinkin reikia pakeisti Evoluti...

Страница 42: ...worden gebruikt breng dan niet meer dan n sheath set tegelijk in een ader in Gebeurt dat wel dan kan ernstig vaatletsel ontstaan met inbegrip van aderwandlaceratie die operatief moet worden hersteld...

Страница 43: ...er ALLE manoeuvres met katheters geleidingsdraden en sheaths uit onder fluoroscopische controle Zorg gedurende de gehele procedure en het ontwaken van de pati nt voor continue bewaking van het ecg en...

Страница 44: ...voorkomen dat de coil en de isolatie uitrekken De ligatuur kan aan de lushandgreep of aan de hechtinglus worden vastgeknoopt NB Als er geen vergrendelstilet gebruikt is denk er dan aan dat de katheter...

Страница 45: ...er het minimaal in het bloedvat ingebracht is of fluoroscopisch bevestigd is dat een midclaviculaire locatie langs de cardiale geleidingsdraad bereikt is Vervang de Evolution Shortie RL gecontroleerde...

Страница 46: ...ingen 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 hypotensjon eller rift i venevegg...

Страница 47: ...r det viktig inspisere den ekstravaskul re kateter avledningskanalen omhyggelig for sikre at alle suturhylser suturer og fikseringsmaterialer blir fjernet Ved fremf ring av hylser herunder Evolution S...

Страница 48: ...ningen ved rotere katetret avledningen og l sestiletten mot urviseren hvis egnet 6 Trekk forsiktig katetret avledningen tilbake for se om det stadig sitter fast i vevet Hvis katetret avledningen sitte...

Страница 49: ...kes Evolution Shortie RL dilatatorhylsesett med kontrollert rotasjon n r minimal tilgang til karet er blitt bekreftet skal Evolution Shortie RL dilatatorhylsesett med kontrollert rotasjon utskiftes me...

Страница 50: ...interwencji chirurgicznej Gdy u ywany jest mandryn blokuj cy Cewnika odprowadzenia nie wolno zostawia bez nadzoru w ciele pacjenta je li w cewniku odprowadzeniu umieszczony jest nadal mandryn blokuj...

Страница 51: ...torowanie EKG i t tniczego ci nienia krwi W przypadku stosowania koszulek lub zestaw w koszulek w tym r wnie zestawu koszulek rozszerzaj cych Evolution Shortie RL z regulacj obrotu nale y przestrzega...

Страница 52: ...i ganiu si zwoju i materia u izolacyjnego Podwi zk mo na przywi za do 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 odprowadz...

Страница 53: ...nie do naczynia lub podgl d fluoroskopowy potwierdzi osi gni cie umieszczenia w lokalizacji rodkowoobojczykowej wzd u odprowadzenia sercowego Wymieni zestaw koszulek rozszerzaj cych Evolution Shortie...

Страница 54: ...Quando utilizar um estilete de fixa o N o deixe ficar colocado num doente um cateter ou el ctrodo quando ainda tiver no seu interior um estilete de fixa o A presen a de um cateter ou el ctrodo r gido...

Страница 55: ...vem ser tomadas as seguintes precau es Antes de utilizar as bainhas incluindo o conjunto de bainha de dilata o com rota o controlada Evolution Shortie RL essencial inspeccionar cuidadosamente o tracto...

Страница 56: ...o isolamento A ligadura pode ser presa ao punho do la o ou ao la o de aperto do fio de sutura NOTA Se n o tiver usado um estilete de fixa o tenha aten o aos danos no cateter ou el ctrodo provocados qu...

Страница 57: ...nto ao el ctrodo card aco consoante o que ocorrer primeiro Troque o conjunto de bainha de dilata o com rota o controlada Evolution Shortie RL pelo conjunto de bainha de dilata o com rota o controlada...

Страница 58: ...58 Evolution Shortie RL Evolution Shortie RL Evolution Shortie RL 9 Fr LR EVN SH 9 0 RL 11 Fr LR EVN SH 11 0 RL Evolution Shortie RL Cook Evolution Shortie RL Evolution Shortie RL J J...

Страница 59: ...59 Evolution Shortie RL Evolution Shortie RL LEAD EXTRACTION Evolution Shortie RL Evolution Shortie RL Evolution Shortie RL...

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

Страница 61: ...Shortie RL 8 Evolution Shortie RL Evolution Shortie RL 9 10 Evolution Shortie RL Evolution Shortie RL 11 Evolution Shortie RL Evolution RL Evolution Shortie RL Evolution Shortie RL Evolution Shortie R...

Страница 62: ...eller migration av den kvarl mnade mandr ngledaren Till mpa inte viktad traktion p en inf rd l smandr ng eftersom avulsio i myokardiet hypotoni eller venv ggsruptur d kan uppst T nk p att en elektrod...

Страница 63: ...nt granska det extravaskul ra kateter elektrodomr det f r att s kerst lla att alla suturhylsor suturer och fixeringsmaterial avl gsnats N r hylsor inklusive Evolution Shortie RL dilatatorhylsset f r s...

Страница 64: ...troden och l smandr ngen moturs om till 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...

Страница 65: ...rhylsset f r styrd rotation anv nds n r minimal tkomst i k rlet har verifierats ska Evolution Shortie RL dilatatorhylssetet f r styrd rotation bytas ut mot Evolution RL dilatatorhylssetet f r styrd ro...

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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