MEDTRONIC VASCULAR ACCESSORlES:

MAXIMUM GUIDE WIRE DIAMETER 0.020"

Copyright © 2009 by Medtronic, Inc. All rights reserved. Printed in the U.S.A.

PK90161 Rev 08

INFORMATION FOR

USE

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Mlllllt/ucturl'r.­

i\ledtronic, Inc. 7[0 Medtronie Parkway Minneapolis. MN 55432 USA Tel.: 763/514-4000. 8001328-25 [8

EC Authoriud Rl'pf(!�·I'"t{/ti.·I''­

Medtronic Ireland I'arkmore Business Park West Ga[way. [rc[3nd Tel.: +353-91-708000

Fax: +353-9[-757524 Fax: 763/514-4879

I STERILE I EO I Sterilized Using Ethylene Oxide I

SteriJizirano etilen oksidom I Sterilizovfmo etyJenoxidem I Steriliseret med ethylenoxid I

Gesteriliseerd met ethylcenoxide I Steriloitu etyleenioksidilla I Sterilise a I'oxyde d'ethylene I Mit Ethylenoxid sterilisiert I A1toan:tpWe.,Kt: )1t: O�Eioto TOU AteuA£viou (EtO) I Etilenoxiddal sterilizitlva I Sterilizzato con ossido di etilene I Sterilisert med ctylenoksid I Stcrylizowane tlcnkiem etylenu I Esterilizado com 6xido de etileno I Sterilizat eu oxid de etilena I

CTepl1.rHl30BaH 3TllneHOKClIllO�' / Sterilizovano koriscenjem etilen oksida /

Sterilizovane etylenoxidom I Esterilizado con 6xido de etileno /

Steriliserad med etyJenoxid / Etilen oksit kullantlarak sterilize ediltni�tir

Open here / Ovdje otvoriti I Zde otevi'ete I Abnes her / Hier openen I Avataan tasta I Ouvrir iei I HierofTnen I Avoi�rt: EOW lin nyilik I Aprire qui / Apnes her I Otwierac lu I Abrir Aqui I Deschide\i aiei I OrKpblBaTb 311CCb I Olvori!i ovdc I

Tu otvorte I Abra por aqui / Oppnas har I Buradan Ar;mtz

II 11111 PK90161 Rev.OS

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MEDTRONIC VASCULAR ACCESSORIES

MAXIMUM GUIDE IMRE DIAMETER 0.020" INFORMATION FOR USE

READ INSTRUCTIONS PRIOR TO USE RefC1" to the End of this document foc symbol definitims

Contents of Package

Cmtains one oc moce of the following Y -Adapter with HEmootasis Valve. Tri-AdaptC1" with Hemostasis Valve. Metal Guide Wire InsErlim Tool. or Steering Handle

Indications The Medlrmic Vascular Accessct"'j devices are to be used to facilitate the use of cathetC1"s and guide wires during intENEntimal procedures. The

Yfrri-Adapter with HEmootasis Valve(s) is designed to be used on a guiding cathetC1" oc dilatatim catheter to cmlrol backbleeding and to provide a perl foc inlroductim of fluids into the intENentional systEm. The Guide Wire Insertim Tool is designed to facilitate placEmEnt of a guide wire tip thrcugh the Yfrri-AdaptC1" and into the wire lumEn of an intEr1Entimal cathe!ff. The Guide Wire Steffing Handle is designed to hold a omall diametC1" guide wire and provide a handle foc manipulating the wire.

Warnings • These imtnlIllEnts are designed foc use by physicians engaged in the

pradice of a opecialized branch of medicine Use of these devices ohculd be re:irided to those opecialds trained to pErlmn the procedure

• ImprcpC1" tightening of the cmnectim between the Yfrri-AdaptC1" and accorrvanying equipmEnt may result in introdudim of air into the vascular syotEm

• Foc single patiEnt use mly. Do not reuse. reprocess oc restErilize this produd. Reuse. reprocessing oc resterilization may ccmprcmise the otrudural integrity of the device andloc create a risk of cmtaminatim of the device which could re:oult in patient inJUIY. illness or death. Cleaning. disinfectim and rdC1"ilizatim may ccmprcmise the essEntial matC1"ial and design charadC1"istics of the device leading to device failure

Precautions • This device has been delivered Sterile. Thcroughly inspect the device

prior to use to verify that no damage has occurred during handling. If the package andloc its cmtents have been damaged. or cmtaminatim oc damage is ruspect.ed foc any reasm. cmtadMedtrmic

Instructions for Use If the Yfrri-AdaptC1" is to be used with a guiding catheter 1 Thread the dilatim catheterthrcugh the hole in the cap of the Yfrri­

AdaptC1". Flush thoccughly to remove air. 2 Advance the dilatatim cathetC1" into the guiding cathetC1" 3 To Join the rctating cmnedoc of the Yfrri-AdaptC1" (with the dilatatim

cathetC1" passing through it) to the guiding cathetC1". vigoccusly flush faward through the adaptC1" to rEmove air while allowing backbleeding thrcugh the guiding cathe!ff. This will pEmlit a fluid-fluid intErlace while the adaptC1" is attached to the guiding cathetC1".

If the Yfrri-AdaptC1" is to be used with a dilatation cathetC1" 1 Attach the rctating connedoc to the hub of the dilatatim cathetC1" 2. Flush thoccughly to remove any air that might be trapped in the device

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3 Insert the dictal tip of the apprcpriate guide wire into the hub of the &Jide wire insErtim tool. InsErt the guide wire insErlim tool thrcugh the Yfrri­Adapt8- and advance the guide wire into the desired device

4 REmove the guide wire insertion tool, and tighten down the Yfrri-Adapt8' hEmootasis valv�s) until no backbleeding is evidEnt

Guide Wire Steering Handle 1 Advance the apprcpriate &Jide wire into the lUITlffi of the dilatim cathere-. 2. Slide the oteering handle CN8' the proximal End of the guide wire and

tighten the handle on the wire

Storage • Stoce accessocies in a clean, cool and darl< area • All Accesscry Products are foc Single Use Only • Do net inJed any fluid if air bubbles are visible within the Yfrri-Adapt8'. • The maxirrum reccrumended inJectim pressure thrcugh the Yfrri-

Adapt8' is 300 psi (2068 kPa)

WARRANTY DISCLAIMER - UNITED STATES Nete Althcugh the Vascular Accessocies, hereaft8' referred to as "producf', has beEn manufadured under carefully controlled cmditims, Medtronic, Inc , and affiliates (colledively, "Medlrmic") have no control ov8' conditions und8' which this produd is used. Medlrmic therefore disclaims all warranties, bcth expressed and implied, with respect to the produd including, but net limited to, any implied warranty oc mEIThantability oc fitness foc a particular purpose, shall not be liable to any p8'sm oc Entity foc any medical expenses or any dired, incidffital oc consequEntial damages caused by any use, defed, failure or malfunctim of the produd, wheth8' a claim foc "-lch damages is based upon warranty, cmtrad, tat or othC1'Wise

No p8'son has any authocity to bind Medtronic to any represEntatim or warranty with resped to the product

The exclusions and limitations set out above are not intEnded to and shculd not be cmslrued so as to cmtravene mandatory provisions of applicable law. If any part oc term of this Disclaim8' of Warranty is held to be illegal, UllEnfocceable or in cmflid with applicable law by a ccurt of competEnt Jurisdidion, the validity of the remaining pcrtims of this Disclaim8' of Warranty ohall not be affected

WARRANTY DISCLAIMER - OUTSIDE UNITED STATES Althcugh the Vascular Accessocies, hEreafter referred to as "Froducf' has beEn carefully designed, manufactured, and tested prioc to sale, the Froduct may fail to p8'fonn its intEnded fundim satisfadocily foc a variety of reasms. The warnings cmtained in the Frodud labeling provide more detailed infonnatim and are cmsid8'ed an integral part of this Disclaim8' of Warranty Medtronic th8'efoce disclaims all warranties, bcth expressed and implied, with respect to the Produd. Medlrmic ohall net be liable for any incidEntal or cmsequEntial damages caused by any use, defed, oc failure of the Frodud, wheth8' the claim is based m warranty, cmlract, tat,

oc ctherwise

The exclusions and limitatims set cut above are not intEnded to, and ohculd net be com1rued so as to contraVEne mandatcry prCNisims of applicable law. If any part orterm of this Disclaim8' of Warranty is held to be illegal, unenfocceable, oc in cmflict with applicable law by a ccurt of competent Jurisdictim, the validity of the nmaining portims of this

Disclaimer of Warranty ohall net be affected and all rights and obligatims ohall be cmstIUed and enfocced as if this Disclaim8' of Warranty did net contain the particular part octenn held to be invalid

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Steering Handle! Ru�ica za upravlJanJe! Ovl§.daci drlak:! Styring,h1ndtag! Stuurgreep! OhJainkahva! Poignee

d' ocientation! Leitgnff! Aaj3Tj m805frrrlary;! Inillyitocar! Impugnatura di ocientamento! Lede±aft! Umwyt do sterowania !Manipulo de encaminhamento! Maner de direqionare! YnpaBmIlOlilaR p)'KollTKa! Ru6ca za navodenJe! Ovl§.daci drtiak! Rctoc de coolrol! St�handtag! Y mlendirici Sap

I Steering Handle I Steering Handle! RuCica za upravlJanJe! Ovl§.daci drlak:! Styring,Mndtag! Stuurgreep! OhJainkahva! Poignee

d' ocientation! Leitgnff! Aaj3Tj m805frrrlary;! Inillyitocar! Impugnatura di ocientamento! Lede±aft! Umwyt do sterowania !Manipulo de encaminhamento! Maner de direqionare! YnpaBmIlOlilaR p)'KollTKa! Rucica za navodenJe! Ovl§.daci drtiak! Rctoc de cmlrol! St�handtag! Y mlendirici Sap

Tri-Adapt<:1' ! Tri-adapter! TroJceslny adapter! Tre-adapter ! Tri -adapt<:1' ! Adaptador lrifurcado! Adaptateur en lri! Tri-Adapt<:1' ! Tp O'lAc.; IIpooap flOYECt. ! Hitrmascsatlakozo! Adaltatoce a tre vie! Tri­adapt<:1'! Adapt<:1' Tri! Tri-Adapter! Adaptoc cu trei di !TpOOHOfi a,I1amep! Tri-adapt<:1'!

TroJceslny adapter! Adaptadoc Ti! Kolmisuunta-adapteri! Tri-Adaptoc

Y -Adapter! Y -adapt<:1'! Adapter tvaru Y ! Y -adapt<:1'! Y -adapt<:1'! Adaptadoc bifurcado! Adaptateur en Y ! Y -Adapt<:1'! IIpooC4'flc:rECU; Y ! Y csatlakozo! Adattatore a Y ! Y -adapt<:1'! Adapt<:1' Y !

Y -Adapter !Adaptoc in Y ! Y-c6pactlbrfi a,[1amep ! Y -adapter! Adapter tvaru Y ! Adaptadoc en "Y" ! Y -adapt<:1'i! Y -Adapt6r

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tPF------Metal Guide Wire Insertion Tool! Metalno p cmagalo za uvo1enJe lice vodilice I KOIlovy m\.otroJ na zavadffii vodicfho drittu I Indfaringsim1n.lIllffit til metalguidewire! Metalffi voerdraadinbfEflgC1'! Metallinffi y::htimen sisaanvieJtI! Introducteur de guide melallique! FDhrungsdraht-EinfDhrllilfe aus Metal!! McruA:\1.KO EwaycoyEa OOTJYotl I,Jpflaroo:;! V ezetOhuzalt bevezet6 fEmeszk6z IIntroduttocep<:1' filo guida metallico! Innsettingsimtrumffit av metal! for ledesmde! Narz�zie do wprowadzania metalowego prowadnika! Instrumento met:ilico de insen;:ao ! Imtn.llllffit de introducEre a firului de ghidaJ moctalic!

MerannH'lecKllH HHCIp)lM€HT):Im ffiejlffiHlI npooOJlo'IHoro llpOBOgHHKa! Metalno pcmagalo za ubacivanJe tice vodilJe! KOIlCNY nam-OJ na zavadzanie vodiacffio drCtu! Herramiffita de insEITim guia metalico! Ledartnl.dinfocare av metal! IMetal Kllavuz Teli :tnsersiyonu Aleti

I V-Adapter and Insertion Tooll Y -Adapter and Insertim Tool! Y -adapter i p emagalo za uvo1enJe! Adaptf1- tvaru Y a zavadeci nHroJ! Y -adaptE3' og indf<Mingsimtrumffit!

Y -adaptE3' ffi inbrengE3'! Y -seNite Ja sisaanvientivaline! Adaptateur ffi Y et introducteur! Y -AdaptE3' lllld EinfDhrhilfe! IIpooCtpT1pTl Y WI EpyaAElo ctoaycorTl;! Y csatlakozo es bevezeto eszk6z! Adattatoce aYe introduttore! Y -adapter og inseltingsinruumffit! AdaptE3' Y i narz�dzie do wprowadzania! Adaptador em Y e Ferramenta de Introdu9ao! Adaptorin

Y �i instrument de introducere! Y -06pa.:3HbIi1 a):lamep H HHCIp)lM2HT):Im BBe,IleHHlI! Y -adaptE3' i pemagalo za ubacivanJe! Adaptf1- tvaru Y a zavadzaci nao1roJ! Adaptadoc ffi • Y' Y herramiffita de insE3'cicn !

Y -adaptE3' och inf6ringsinruumffit! Y -Adapt6r ve InsE3'siym Aleti

I BUlDEWIRE I

Maximum GW Diameter! Maksimalni premJE3' tice vodilice! Maximalni prumf1-vodiciho dratu! Styrtnl.dffis hbgsta diameter! Maximale diameterv<X1'draad!

Diametro maximo da smda [GW] ! Diarnetre rruxilllJlll du guide! MaximalE3' FUhrungsdrahtdurchmesser! MEy1.OTll li.1<i!J.crpO� OOllYotl Lup flare.; ! Vezetmuzal maximalis almerOJe !Diametro massimo filo guida!

Maksimum ledesondediametE3'! Maksymalna srednica prowadnika! Maksimal diameterpa guidewire !Diametrul maxim al firului de ghidare! MaKCHMl!lbHbIH ):IIJaMerp GW ! Maksimalni preenik tice vodilJe! Maximalny priffilervodiacffio drCtu! Diiunetro maximo del alambre guia! Jchtimffi ffiimmaislapimitta! Maksimum GW (Kllavuz Teli) c;apl

I ADAPTER I

N eminal AdaptE3' ID. ! Nominalni unutarnJi premJE3' adaptera! Neminalni identifikami cislo adapteru! Adapterns nominel!a innerdiameter! Nominale binnffidiametE3' adapter I Difunetro intE3'iornmnal do adaptador! Diametre intf1-ieur neminal de l'adaptateur!

NominalE3' Adapter (innerer DurmmessE3')! EOCOT Ii. 1<Jt.! 0 "'l-laart.n'j TIp ooapfloyEa.; ! Csatlakozo

nevleges belso almerOJe! Id di adattatoce nominale! Nominel! indre diameter foc adaptE3'! Neminalna :Iednica wewn.pzna adaptE3'a! Neminel indVffidig diametE3'pa guidewire! Diametrul intern neminal! HCMIlHaJIlliali

ll):lffi11l¢HKallHlI a):lamepa! Neminalni unutra!TIJi preenik adaptera! Neminalne identifikame Cislo adaptf1-a! Diiunetro intemo del adaptadoc nominal! Adapterin nimellissisalapimilta !Nominal Adapta- 19 c;apl

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