GuideLiner® V3 catheter
`Instructions For Use
`USA CAUTION
`Federal law restricts this device to sale by or on the order of a
`physician.
`DEVICE DESCRIPTION
`The GuideLiner catheter is a single lumen rapid exchange catheter
`offered in sizes compatible With SF, SF 7F and BF guide catheters
`and may be placed over a standard length guidewire The larger
`sees of GuideLiner catheters are intended to be used Within the
`proximal portions of the coronary vasculature to provide support and/
`orfacilitate use of multiple interventional devices. The 150cm deVice
`has a 125cm stainless steel shaft section covered on the distal 17cm
`With a semircircular polymer The steel shaft is followed distally by a
`25cm lumen section wiped With silicone.
`The GuideLiner catheter has two pIaIll’lUITIrlfldlum marker bands,
`which enable visibility While using standard fluoroscopic methods.
`The distal marker band is located on the distal tip. The proximal
`marker band is located nearthe collar The device has two
`positioning marks located at 95cm (single mark) and 105cm (double
`mark) from the distal tip.
`The GuideLiner catheter is delivered through a guide catheter
`resulting in an inner diameter that is approximately1 French smaller
`than the guide catheter. The GuideLiner catheter has a proximal
`tab which indicates guide catheter compatibility and the resulting
`GuideLiner catheter inner diameter.
`The GuideLiner catheter has been sterilized with ethylene oxide
`
`
`SPECIFICATIONS
`
`Compatible
`Guide
`Catheter
`2 5F
`(2 0056"/
`142mm| D)
`2 GF
`(2 0066"/
`1.68mm |.D)
`
`GuideLiner
`Minimum I.D.
`0 046"
`
`(1.17mm)
`0 051"
`
`(1.30mm)
`
`GuideLiner
`Tip 0D. (X)
`0.053“
`
`(1 35mm)
`0 063“
`
`(1 60mm)
`
`
`
`
`
`
`
`
`5571
`(a 38;]. 1
`0 056"
`o 067“
`6F
`1.78mm ID)
`(1 42mm)
`(1 70mm)
`
`
`5572
`(> Z 358"]
`0 062"
`0 075“
`7F
`1.98mm |.D)
`(157mm)
`(1 90mm)
`
`5573
`SF
`
`(> 308:8"1
`224mm ID)
`
`0 D71"
`(1 80mm)
`
`0 085“
`(216mm)
`
`
`
`INDICATIONS
`GuideLiner catheters are intended to be used in conjunction with
`guide catheters to access discrete regions of the coronary and/or
`peripheral vasculature, and to facilitate placement of interventional
`devices.
`CONTRAINDICATIONS
`The GuideLiner catheters are contraindicated in vessels less than
`2 5mm in diameter and in vessels in the neurovasculature orthe
`venous system
`WARNINGS
`The GuideLiner catheter is provided sterile for single use only Reuse
`of single-use deVices creates a potential risk of patient or user
`infections and may compromise device functionality which may lead
`to illness or serious patient injury
`Never advance the GuideLiner catheter into a vessel Without a
`leading guideWire as vessel damage may result
`Never advance the GuideLiner catheter into a vessel With an
`effective diameter less than 2 5mm Vessel injury and/or occlusion
`may result
`If pressure in avessel dampens after inserting the
`GuideLiner catheter, withdraw the catheter until the pressure returns
`to normal
`Due to the size and non-tapered tip of the GuideLiner catheter,
`extreme care must be taken to avoid vessel occlusion and damage
`to the wall of the vessels through which this catheter passes.
`Never advance or withd raw an intravascular device against
`resistance until the cause of the resistance is determined by
`fluoroscopy Movement of the catheter or guideWIre against
`resistance may result in separation of the mtheter or guideWire tip,
`damage to the catheter, or vessel damage
`
`GU/defll'fl6f‘
`
`V3 catheter
`English/Instructions for Use ........................................ 1
`Cesky/Na’vod k pouiiti.
`Dansk/Brugsanvisning.
`Nederlands/Gebruiksaanwuzing
`Eesti/Kasutusjuhised
`Suomi/Kayttoohjeet ..
`Francais/Mode d’emplo .
`Deutsch/Gebrauchsanweisung
`EMijvmd/06ijyici; )(pfioijg
`Magyar/Hasznalati Litasitas
`Italiano/Istruzioni per I'uso.
`Latviski/Lietosanas instrukcija
`LietuviLj/Naudojimo instrukcijos.
`Norsk/Bruksanvisning .............
`Polski/Instrukcja obsiugi...
`Portugués/Instrugées de utilizacao
`Pyocxm‘i/VchrpykLiMSI no I'lleMeHeHMIO
`Espafiol/lnstruociones de uso..........
`Svenska/Bruksanvisning
`Tiirkce/Kullanim Talimatlar
`SIovenéina/Navod na pouZiIie
`Tiéng Viei/Hm'yng dan so clung.
`Hrvatski/Upute za uporabu ..
`Srpski/Uputstvo za upotrebu
`Roméné/Instructiuni de utilizare ............
`YKpa'i'HcsKa/IHoprKLii'I' Lina aaCTocyBaHHa
`:i wilw,/vi’i_iii:il'a‘na~fux ni'le'i'u .............................................. 24
`
`
`
`'Il'eleflew
`
`Vascular Solutions LLC
`
`6464 Sycamore Court North
`Minneapolis, MN 55369 USA
`Phone: (866) 246—6990
`Fax: (866) 804-9881
`
`Teleflex Medical
`
`IDA Business and Technology Park
`Dublin Road, Athlone
`Co. Westmeath, Ireland
`
`CE
`0086
`
`©2018 Vascular Solutions LLC
`
`Page 1
`
`PRECAUTIONS
`Do not use the GuideLiner catheter ifthe packaging has been
`damaged A damaged package could result in a breach of sterility or
`device damage.
`Inspect the GuideLiner catheter prior to use for any bends or kinks.
`Do not use a damaged catheter Vessel damage and/or inability to
`advance or Withdraw the catheter may occui.
`The catheter lumen should be flushed with sterile, heparinized saline
`prior to use to prevent clot formation and to ensuie the catheter is
`free from debris which could be introduced into the body resulting in
`an embolism and/or occlusion.
`Precautions to prevent or reduce clotting should be taken when any
`catheter is used in the vascular system.
`Exercise care in handling of the catheter during a procedure to
`reduce the possibility of accidental breakage, bending or kinking. Do
`not apply torque to the catheter during delivery, as catheter damage
`may result
`When the catheter is in the body, it should be manipulated only
`under fluoroscopy Do not attempt to move the catheter without
`observing the resultant tip response, as catheter damage or vessel
`injury may occur.
`Never advance the GuideLiner catheter more than 10cm beyond the
`tip of the guide catheter as the GuideLiner catheter may become
`lodged in the guide catheter making it difficult to remove
`Do not Withdraw an undeployed stent back into the GuideLiner
`catheter when the catheter is in the body, as it may result in
`dislodging the stent. Instead, simultaneously pull both the GuideLiner
`catheter and undeployed stent back into the guide and remove
`together
`ADVERSE EFFECTS
`Potential adverse effects that may be associated With the GuideLiner
`catheter include, but are not limited to, thefolloWing
`-
`Cardiac arrest
`-
`Embolism
`-
`Infection
`-
`Myocardial infarction
`-
`SIow—llow/Occlusion
`-
`Stent dislodgement
`-
`Thrombosis
`-
`Vessel dissection
`-
`Vessel perforation
`CLINICAL PROCEDURE
`The GuideLiner catheter should be used by physicians trained on the
`procedures for which it is intended. The techniques and procedures
`described do not represent ALL medically acceptable protocols, nor
`are they intended as a substitute forthe physician’s experience and
`judgment in treating any specific patient. All available data, including
`the patient’s signs and symptoms and other diagnostictest results
`should be considered before determining a specific treatment plan
`PACKAGE CONTAINS:
`1X Catheter
`
`2.
`
`3.
`
`OTHER ITEMS REQUIRED BUT NOT PROVIDED.
`Guide catheterWith an inner diameter large enough to
`accommodate the specific model of GuideLiner catheter in
`use
`Y-adaptorWith hemostasis valve (Tuohy-Borst type)
`-
`Guidewrre With diameters 0.014" / 0.36mm
`-
`Sterile syringe (for flushing)
`-
`Sterile heparinized saline (for flushing)
`-
`PREPARATIONS FOR USE
`Prior to use, carefully inspect the GuideLiner packaging and
`components for damage.
`Using sterile technique, transferthe dispenser coil with the
`GuideLiner catheter into the sterile field.
`Remove the GuideLiner catheter from the dispenser coil and
`thoroughly flush the lumen of the GuideLiner catheterfrom the
`distal tip With sterile heparinized saline solution
`DEPLOYMENT PROCEDURE
`Deploy the G uideLiner catheter according to the following steps
`1.
`Secure the preVIously inserted guideWire and backload the
`distal tip of the GuideLiner catheter onto the guidewire and
`advance until the catheter isjust proximal to the hemostasis
`valve.
`Open the hemostasis valve and advance the GuideLiner
`catheterthrough the hemostasis valve and into the guide
`catheter
`Under fluoroscopy, advance the GuideLiner catheter beyond
`the distal tip of the guide catheter and into the desired location
`within the vessel
`WARNING: Never advance the GuideLiner catheter into a
`vessel with an effective diameter less than 2.5mm. Vessel
`injury, ischemia, and/or occlusion may result. If pressure
`in a vessel dampens after inserting the GuideLiner
`catheter, withdraw the catheter until the pressure returns
`to normal.
`WARNING: Due to the size and non-tapered tip of the
`GuideLiner catheter, extreme care must be taken to avoid
`vessel occlusion and damage to the wall of the vessels
`through which this catheter passes.
`
`2.
`
`3.
`
`103807 Rev A 06/18
`
`VSIMDTOOOO3824
`
`Teleflex Ex. 2144
`
`Medtronic v. Teleflex
`
`IPR2020-00135
`
`
`Page 1
`
`Teleflex Ex. 2144
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`4.
`
`5.
`
`6.
`
`7
`
`8.
`
`Using fluoroscopy confirm the desired position of the
`GuideLiner catheter in the vessel.
`lf performing an interventional procedure, backload the
`interventional device over the existing guideWire and advance
`the device through the guide catheter and GuideLiner catheter
`into the desired vascular space
`NOTE: If a second wire is used during the intervention
`and encounters resistance within the guide catheter. pull
`the wire back several centimeters and slowly readvance.
`Tighten the Y—adaptor hemostasis valve securely on the
`proximal shaft of the GuideLiner catheter to prevent backr
`bleeding.
`Perform the catheterization procedure Af‘ter complebng the
`procedure remove the GuideLiner catheter prior to remoVing
`the guide catheter from the vessel.
`Dispose of the GuideLiner catheter following standard hospital
`procedures.
`STORAGE & HANDLING
`No special storage or handling conditions.
`LIMITED WARRANTY
`Vascular Solutions LLC warrants that the GuideLiner catheter is
`free from defects in workmanship and materials prior to the stated
`expiration date Liability underthis warranty is limited to refund or
`replacement of any product, which has been found by Vascular
`Solutions LLC to be defective in workmanship or materials. Vascular
`Solutions LLC shall not be liable for any incidental, special or
`consequential damages arising from the use of the GuideLiner
`catheter. Damage to the product through misuse, alteration, improper
`storage or improper handling shall void this limited Warranty
`No employee agent or distributor of Vascular Solutions LLC has any
`authority to alter or amend this limited warranty in any respect Any
`purported alteration or amendment shall not be enforceable against
`Vascular Solutions LLC.
`THIS WARRANTY IS EXPRESSLY IN LlEU OF ALL OTHER
`WARRANTlES, EXPRESSED OR llVIPLlED, INCLUDING ANY
`WARRANTY OF MERCHANTABlLITY OR FITNESS FOR A
`PARTICULAR PURPOSE OR ANY OTHER OBLlGATION OF
`VASCULAR SOLUTIONS LLC.
`PATENTS AND TRADEMARKS
`May be covered by one or more U.S. or international patents.
`See: \MNw.teleflex.com/patents-intv
`GuideLiner is a registered trademark ofTeleflex Innovations S a r l
`Vascular Solutions LLC, or Teleflex Medical, each a part of Teleflex
`l ncorporated.
`See the International Symbols Glossary on page 27.
`See the Content Glossary on page 28.
`
`Katétr GuideLiner® V3
`
`Navod k pouiiti
`UPOZORNENI PRO USA
`Federalni zakon omezuje prodej tohoto zafizeni pouze na
`objednavky uéinéné na pfedpis lékafe.
`POPIS ZARIZENI
`Katetr GuideLinerJe katetr pro rychlou vymenu sJednim lumenem,
`dodayany ve velikostech kompatibilnich s vodicimi kate’try 5 Fr, 6
`Fr, 7 Fr a 8 Fr, ktery' muie byt nasunut na vodici drat standardnl
`delky Katetry GuideLiner vetsi velikostijsou urceny k pouZiti v
`proximalnlch oddilech koronarnich cev a maji poskytovat podporu
`a usnadnit pouiitl nékolika intervenonioh zaiizeni'. Zailzeni o de’loe
`150 cm ma' cast tela z nerezové oceli c delce 125 cm potaienou na
`distalnich 17 cm polokruhovym polymerem Na ocelovou cast tela
`navazuje distalne cast lumina o delce 25 cm potaiena silikonem.
`Na katetru GuideLinerjsou dye znacky Z platiny-iridia které pii
`slandardnich skiaskopickych metodach umoir'iuji viditelnost.
`Distalni znackaye umistena na distalnim hrotu Proximalni znacka
`ye umistena blizko krouiku Na zaiizen'i isou take dve znacky pro
`uréenl polohy umistené 95 cm (iednoduché znacka) a 105 cm
`(dyojita znacka) od distalnlho hrotu.
`Katétr GuideLiner se zavadi vodicim katetrem, coi znamena. 2e
`vnitini prumerje piibliine 01 French mensi nei VOdlCl kate'tr.
`Na katetru GuideLinerJe proximalnl stilek. na kteremie vyznac'ena
`kompatibilita s vodicim katetrem a vysled ny' vnitini prumer kate'tru
`GuideLiner.
`Katetr GuideLinerje sterilizovan ethylenoxidem
`
`
`
`©2018 Vascular Solutions LLC
`
`SPECIFIKACE
`
`Minimalni
`Vnéjsi prumér
`vniti‘ni pru mer
`hrotu katetru
`Kompatibilni
`katetru
`GuideLiner
`
`Model
`zavadéci katetr
`GuideLiner
`(X)
`l——————
`r
`
`5569
`5F
`
`(vnitizniapil’imer
`2 dose/1,42 mm)
`
`0’046"
`“‘17 mm)
`
`0’053"
`(1 35 mm)
`
`
`5570
`(vnitifnisprillmér
`0051"
`0363"
`5 SF
`2 0,066" / 1,68 mm)
`“‘30 mm)
`(1 60 mm)
`
`
`5571
`(antfnlspillmér
`0’056"
`0’067"
`6F
`2 0,070.. l 1.78 mm)
`(1.42 mm)
`(1 70 mm)
`
`
`
`
`
`5572
`(vnitiEanFrl‘imér
`0’062"
`0’075"
`7F
`2 0,078"/ 1.98 mm)
`(1.57 mm)
`(1 90 mm)
`
`537:3
`
`(vnitiEnlSpFrrumér
`2 0,088" / 224 mm)
`
`(1%371" )
`.
`mm
`
`(22385" )
`mm
`
`Wm"
`A
`gomISDCm—mvl
`l
`Wm
`l4—25m._.
`.9
`
`INDIKACE
`Katetry GuideLinerjsou uréeny k pouZiti spoleéne s vodicimi katetry
`pii piistupu do definovanych oblasti koronarnich nebo perifernich
`cev a k usnadneni umlsteni intervenénlch zaiizeni
`KONTRAINDIKACE
`Pouiiti kate'tru GuideLinerje kontraindikovano v cévach o pruméru
`mensim nei 2,5 mm, v cévach neurovaskulatury a v illnlm syste’mu.
`VAROVANI
`Katetr GuideLinerje dodavan sterilnl a je uréen pouze k
`Jednorazovemu pouZiti Opakovane pouiivani prostiedku
`kyednorazovému pouiitl yystavuje pacienta nebo uiivatele
`potencialnimu riZiku infekce a mflie narusit funkcnost prostiedku.
`coZ muie vest konemocnéni nebo vaine zdrayotni UJme pacienta.
`Katetr GuideLiner nikdy nezavadejte do cevy bez yedouciho
`vodiciho dratu, protoie by mohlo doiit k poskozeni cevy
`Katetr GuideLiner nikdy nezavadejte do cevy s efektivnlm prumerem
`mensim nez 2,5 mm lVlohlo by dOJlt k poraneni nebo okluzi
`cevy Pokud se po zavedenl katétru GuideLiner v cévé sniil tlal<,
`vyta'hnete katetr GuideLiner a2 do doby, kdy se tlakyratl k normalu
`Vzhledem l< tomu, ie konec katetru GuideLiner neni zuieny,
`a vzhledem kjeho velikosti je nutno postupovat s maximalni
`opatrnosti, aby nedoslo k okluZI cevy a poskozeni steny cevy, kterou
`katetr prochazi
`Nikdy nezavadejte ani nevylahuyte intravaskularni zaiizeni, cititerli
`cdpor Nejprve zjistéte piiéinu odporu pomocl skiaskopie Pohyb
`katetru nebo vodiciho drétu proti odporu mtiie vest k odtrieni hrotu
`kate'tru nebo vodiciho dra'tu. k poskozeni katetru nebo k poskozeni
`cevy
`BEZPECNOSTNI OPATRENI
`Katetr GuideLiner nepouéivejte, pokud doslo k poskozeni obalu
`Poskozenl obalu muie zpusobit narusenl sterility nebo poskozenl
`prostiedku.
`Pied pouiitim katetr GuideLiner prohlédnete, zda neni ohnuty
`nebo zauzleny Poskozeny katetr nepouii’vejteMohlo by to vest k
`poskozeni cevy a/nebo k nemoZnos‘ti katetr zavest nebo vytahnout
`Lumen katetru Je treba pied pouZitim proplachnout sterilnim
`heparinizovanym fyziologickym roztokem, aby se zabranilo vytvoieni
`sraienin a aby bylo zajisteno, ie V katétru neni usazenina, ktera'
`by mohla byt zanesena do téla a mohla by zpfisobit embolii a/nebo
`okluzi
`Pii pouiiti’ jakehokoli katetru v cevnim systému je tieba prijmout
`bezpec'nostni opatieni pro prevenci nebo redukci vytvoienl sraz'enin
`Pii manipulaci s kate'trem behem vykonu postupuyte opatrne, abyste
`SanIII llZlkOJEI'ID nahodneho pietrieni, ohnutl nebo zauzleni Behem
`zavedenl katétru nepUsobte na katetr krouticim momentem protoie
`by mohlo dojit kjeho poskozenl.
`Je-li katetr zaveden uvnifi' tela, smi se s nim manipuloyat pouze
`pod skiaskopickcu kontrclou Nepokousejte se hybat katetrem, aniZ
`byste sledovali vysledny pohyb Jeho hrotu protoZe by mohlo doiit k
`poskozeni katétru nebo poraneni cév
`Katetr GuideLiner nikdy neposouveite dale nei 10 cm za hrot
`vodioiho katetru, protoie by katetr GuideLiner mohl uviznoutve
`vodicim katetru a jeho vyjmuti by bylo obtiine'
`Nerozvinuty stent nevtahujte zpet do katetru GuideLiner, pokud se
`kate'tr nachazl v tele protoie by to mohlo ve'st k dislokaci stentu
`Namisto toho soucasne zatahnete katetr GuideLiner i nerozvmuty
`stent zpet do vodiclho katétru a vyjmeteje spolecne
`
`NEZADOUCI UCINKY
`lVleZI potencialni nezadouci ucinky, ktere mohou souVIset s pouiitim
`katetru GuideLiner, patii mimoJine’
`Srdecni zastava
`Embolizace
`lnfekce
`-
`Infarkt myokardu
`-
`Pomaly prutok/okluze
`-
`Dislokace stentu
`-
`Tromboza
`-
`Disekce cevy
`-
`Perforace cevy
`-
`KLINICKY VYKON
`Katetr GuideLiner by mel pouz'ivat pouze lekai skoleny k vykonflm,
`pro néi je zaiizeni uréenoPopsané techniky a postupy
`nepiedstavuji VSECHNYmedicinsky piijatelne’ protokoly, ani
`nenahraqui zkusenosti lekaie a Jeho Usudek pii lecbe konkretnich
`pacientu Pied rozhodnutim o pilslusném planu le'obyje nutno uvaiit
`vsechny udaje, ktere’ ysou k dispozici, thne znémek a piiznaku
`pacienta a vysledku dalsich diagnostickych yysetreni.
`BALENI OBSAHUJE:
`1 ks kate'tr
`
`-
`-
`-
`
`OSTATNI POTREBN’E POLOZKY. KTE RE
`NEJSOU SOUCASTI BALENI:
`Vodici katetr s dostatecne velkym vnitinim prumerem, aby
`se do nej vesel pilslusny model katetru GuideLiner, ktery ma
`byt pouiit
`Adapter ve tvaru Y s hemostatickym ventilem (typu
`TuohyrBorst)
`Vodici drat o prumeru 3 0.014" / 0,363 mm
`Sterilnl inJekCni stiikacka (k proplachovani systemu)
`Sterilnl heparinizovany fyziologicky roztok
`(k proplaohovani syste’mu)
`PRIPRAVA K PouZiTi
`1.
`Pied pouiitim peclive prohlédnete opal kate'tru
`GuideLiner a Jeho soucasti, zda neisou poskozeny
`Za pouZiti sterilni techniky pieneste zasobnik s katetrem
`GuideLiner do sterilniho pole
`Vyimete katetr GuideLinerze zasobniku a dukladne
`proplachnete lumen katetru GuideLiner od distalnlho hrotu
`sterilnim heparinizovanym fyziologicky’m roztokem.
`POSTUP ZAVEDENI
`Katetr GuideLiner zayadejte podle nasledujici'ch krokfl
`1
`Dilve zavedeny vodici drat zajistete, technikou backload
`nasad‘te distalni hrot katétru GuideLiner na vodici
`drat a zayadeite Jei, a2 bude katetr proximalne temer
`u hemostatického ventilu
`Otevrete hemostaticky yentil a zavedte katetr
`GuideLiner hemostatickym ventilem do Vodiclho katetru
`Za skiaskopicke kontroly zavadeJte katetr GuideLiner Za
`distalnl hrot vodioiho katetru a do potiebného mista v oeve
`VAROVANI: Katétr GuideLiner nikdy nezavadéjte do cévy
`s efektivnirn prumérem mensirn nei 2,5 mm. Mohlo by
`dojit k poranéni, ischemii nebo okluzi cévy. Pokud se po
`zavedeni katétru GuideLiner v cévé sniii tlak, vytahnéte
`katetr GuideLiner a2 do doby, kdy se tlak vrati k normalu.
`VAROVANI: Vzhledem ktomu, 2e konec katétru
`GuideLiner neni zuieny, a vzhledem kjeho velikosti je
`nutno postupovat s maximalni opatrnosti. aby nedoslo
`k oklu ' cevy a poskozeni steny cevy, kterou katetr
`prochazi.
`Pomoci skiaskopie potvrdte, 2e1e katetr GuideLiner
`v potiebne poloze v céve
`Pokud prova'dite intervenc'ni vykon, technikou backload
`nasad‘te piislusne intervencnl zaiizenl na umistény Vodici’ drat
`a zavadejte zaiizeni vodicim katétrem a katétrem GuideLiner
`do poiadovane’ho prostoru v cevé
`POZNAMKA: Pokud je pii lasahu pouiit druhy’ drat a
`VOdICI katetr narazi na odpor, vytahnéte drat o nékolik
`centimetru zpet
`a pornalu jej Znovu zaved’te.
`Bezpecné upey ete hemostaticky yentil s adaptérem ve tvaru
`Y na proximalnl cast tela katetru GuideLiner. aby se zabranilo
`Zpetnemu toku krve
`Provedte katetrizacni vykon Po dokoncenl vykonu yyjmete
`katetr GuideLiner diiye, nei vytahnete vodici katetr z cevy
`Katetr GuideLiner zlikyiduyte podle standardnich
`nemocniénich postupfl
`SKLADOVANI A ZACHAZENI
`Nelsou vyz'adovany Zadne zvlastni podminky pro skladovani a
`ZachazenL
`OMEZENA ZARUKA
`Spolecnost Vascular Solutions LLC zarucuje. 2e na katétru
`GuideLiner nebudou do uplynutl uvedene' doby pouZitelnosti
`vady materialu ani zpracovani Odpovednost podle teto zaruky Je
`omezena na refundaoi nebo vy’ménu1al<ehol<olivyrobl<u, u nehoi
`byly ze strany spoleénosti Vascular Solutions LLC, shledany yady
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`Page 2
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`Teleflex Ex. 2144
`Medtronic v. Teleflex
`IPR2020-00135
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`materialu ci zpracovani'. Spolecnost Vascular Solutions LLC, nebude
`odpovidat za Zadne nahodne, zvlastni 6i nasledne skody vzniklé
`pr: pouzivani katetru GuideLiner Poskozeni vyrobku zpusobena
`nespravnym pouiitim pozmenenim, nespravny'm skladovanim nebo
`nevnodnou manipulaci rusi platnost teto omezene zaruky.
`Zadny zamestnanec, za’stupce ani distributor spolecnosti Vascular
`Solutions LLC, nema’ v Zadnem onledu Zadnou pravomoc pozmenit
`6i doplnit tuto omezenou zaruku Nésledky iakenokoli zamerneno
`pozménéni 5i doplnéni' nebudou u spolecnosti Vascular Solutions
`LLC vymanatelne.
`TATO ZARUKA JE POSKYTNUTA WSLOVNE NAMISTO VSECH
`OSTATNICH WSLOVNYCH NEBO NEPRIMYCH ZARUK, VCErNE
`JAKEKOLI ZARUKY UPLATNITELNOSTI NA TRHU N an
`VHODNOSTI KE KONKRE—I'NIMU UCELU NEBO JAKEHOKOLI
`ZAVAZKU SPOLECNOSTI VASCULAR SOLUTIONS LLC.
`
`PATENTY A OCHRANNE ZNAMKY
`Mflie Wt pFedmétem jednoho nebo vice americwch 6i
`mezina'rodnich patentfl.
`Viz \A/wwteleflex com/patents-intv
`GuideLinerje registrovana ochranna znamka spoleénosti Teleflex
`innovations S.'a.r.l , Vascular Solutions LLC nebo Teleflex Medical,
`klere JSOU vSechny souéas‘ti skupiny Teleflex Incorporated
`Viz glosar mezmarodnicn znaéek na strane 27.
`Viz slovnik poimu na strane 28
`
`GuideLiner® V3-kateter
`
`Brugsanvisning
`ADVARSEL GIELDENDE FOR USA
`lfolge amerikansk lovgivning ma denne anordning kun saelges
`af eller pa foranledning af en liege.
`BESKRIVELSE AF ENHEDEN
`GuideLiner—l(ateteret er et enkeltlumenkateter beregnet til nurtig
`udsKiftning og Ieveres i storrelser, der er kompatible med SF, SF,
`7F og 8F guiderKatetre og Kan placeres over en standardlaengde
`guideWi re De stmrre storrelser G uideLiner-katetre er bereg net til at
`blive anvendt inden for den proximale del at koronarvaskulaturen til
`at yde stdtte og/eller lette brugen at flere interventionelle enheder
`Anordningen pa 150 cm nar en sektion med et skalt i rustfrit stal
`pa 125 cm daekket pa de distale 17 cm at en nalvrund polymer.
`Stalskaftet leges distalt af en Iumensektion pa 25 cm, der er aftzrret
`med silikone
`GuideLiner—Kateteret har to platin-iridium markmband der
`letter aflasningen ved anvendelse at standard fluoroskopiske
`metoder Det distale marl<zirband sidder i den distale spids Det
`proksimale markorbénd sidder naer kraven Anordningen har to
`placeringsmerker placeret 95 cm (enkelt maerkede) og 105 cm
`(dobbelt markede) fra den distale spids
`GuideLinerrkateteret Ieveres gennem et guide Kateter, hVIlket giver
`anledning til en indre diameter der er ca 1 french mindre end guider
`kateteret GuideLiner-kateteret naren proksimal tap der angiver
`guide-Kateterets kompatibilitet og den deraf fwlgende indre diameter
`at GuideLinerrkateteret
`GuideLinerrKateteret er blevet steriliseret med ethylenoxid
`
`SPECIFIKATIONER
`GuideLiner-
`GuideLiner min.
`Knmpatibelt
`
`spids v.0. (X)
`guide-kateter
`LB.
`2 SF
`(2 0,055"/
`1 42 mm i 0)
`2 SF
`(2 0066"]
`1 68 mm i 0)
`2 6F
`(2 0,070"/
`1 78 mm i D)
`2 7F
`(2 0 078'?
`1 98 mm i D)
`2 8F
`(2 0,088" l
`2 24 mm i D)
`
`0,046“ (1,17 mm)
`
`0,051” (1,30 mm)
`
`0,056“ (1,42 mm)
`
`0,067"
`(1,70 mm)
`
`0'085”
`
`0,002” (1,57 mm)
`
`0,071“ (1,80 mm)
`
`t
`x
`
`I
`
`l
`L—lmm
`
`INDIKATIONER
`GuideLinerrkatetre er beregnet til anvendelse sammen med guider
`katetre for at fa adgang ti| diskrete omrader af koronar og/eller perifer
`vaskulatur 09 for at lette placering af interventionelle enheder.
`KONTRAINDIKATlONER
`GuideLiner-katetre er kontraindicereti Kar, der er mindre end 2,5 mm
`| diameter, Kar | neurovaskulaturen og ivenesystemet
`ADVARSLER
`GuideLinerKateteret Ieveres kun sterilt til engangsbrug.
`Gerianveridelse af engangsanordninger skaber en potentiel risiko for
`patient- eller brugerinfekh'oner og kan kompromittere anordningens
`funktionalitet, hvilket kan resultere i sygdom eller alvorlig skade pa
`patienten
`Foraldrig GuideLiner-kateteret ind iet kar uden en ledeguidewire, da
`det kan resultere | karskader
`Fmraldrig GuideLinerrkateteret ind I et kar med en effelctiv diameter
`pa under 2,5 mm Det kan resultere i skader pa karret og/eller
`oKklusion HVis trkaet i at kar aftager, nar GuideLiner-kateteret er
`fort ind, skal GuideLiner—kateteret traeKKes ud, indtil trykket vender
`tilbage til det normale niveau
`Pa grund at GuideLiners storrelse og ikke-koniske spids skal
`du Vere meget forsigtig for at undga karokklusion og skader pa
`veeggene i de kar, nvorigennem dette kateter passerer.
`For aldrig en intravaskuler enhed frem ellertilbage nvis den moder
`modstand, fiar arsagen til modstanden er fastlagt med fluoroskopi
`Bevegelse af Kateteret eller guidewiren ved modstand kan medfrare
`at kateteret eller guideWIrens spids adskilles, at der opstar skade
`pa kateteret eller en perforering af blodkar
`FORHOLDSREGLER
`Anvend ikke GuideLiner—kateteret, hVis emballagen er beskadiget.
`En beskadiget emballage kan resultere i brud pa steriliteten eller
`sKade pa anordningen.
`Underszig GuideLiner-kateteret for buKninger eller knack for brugen.
`Anvend ikke et besKadiget kateter. Der kan opsté sKade pa blodkar
`Ogleller det kan blive umuligt at frem‘fmre eller trakke kateteret
`tilbage.
`Kateterlumen skal skylles igennem med sterilt heparinsaltvand for
`brug for at fornindre dannelse af koagel og sikre, at katetret erfrit for
`rester, der muligvis kan fares ind | kroppen og torérsage emboli og/
`eller okklusion
`Fornoldsregler skal tages for at fornindre eller reducere dannelse at
`koagel, nar et kateter anvendesi karsystemet
`Handter kateteret torsigtigt under proceduren for at reducere risikoen
`for at det knekker ved et uneld, bliver szet eller far et knaek Undga
`at dreie kateteret under indgivelse, da det Kan beskadige kateteret.
`Nar kateteret er i kroppen, bar det kun handteres under fluoroskopi.
`Forsdg ikke at bevaege Kateteret uden at observere spidsens deraf
`falgende reak‘tion, idet der kan forekomme beskadigelse at kateteret
`eller l<arsl<ade
`GuideLiner katetret ma aldrig fares mere end 10 cm laengere frem
`end spidsen at kateterlederen, da GuideLiner katetret kan satte sig
`fast i kateterlederen og gore det svart at fjerne.
`En ikke-anlagt stent ma il(l(e trakkes tilbage ind i GuideLiner nar
`kateteret befinder sig i kroppen, da det kan resultere i losrivelse af
`stenten I stedet skal bade GuideLiner og den iKKeranla‘gte stent
`traekkes tilbage samtidigtfor at fierne dem sammen
`BIVIRKNINGER
`De potentielle bivirkninger, der Kan Vere forbundet med brugen af
`GuideLiner-kateteret
`inkluderer, men er ikke begrenset til, folgende
`-
`Hiertestop
`-
`Emboli
`-
`lnfektion
`-
`lVIyokardieinfarkt
`-
`Langsom gennemstromning/okklusion
`-
`Stentldsrivelse
`-
`Trombose
`-
`Kardissektion
`-
`Karperioration
`KLINISK PROCEDURE
`GuideLiner-kateteret bar anvendes af leeger, der er uddannet i de
`procedurer, som anordningen er beregnet til. De beskrevne teknikker
`og procedurer reprasenterer ikke ALLE Iaegeligt acceptable
`protokoller cg de er neller ikke beregnet som en erstatning for
`legens erfaring og vurdering under behandling afen specifik patient
`Alle tilgangelige data, herunder patientenstegn og symptomer og
`andre diagnostiske testresultater, bur tages med i betragtning for en
`specifik behandlingsplan fastsaettes.
`PAKKEN INDEHOLDER:
`1x kateter
`
`ANDRE TING SOM KRlEVES, MEN IKKE
`MEDFQLGER:
`-
`Guide-Kateter med en indre diameter, der er stor nok til at
`nave plads til den anvendte type model GuideLiner-kateter
`Yradapter med haemostaseventil (TuohyrBorst typen)
`Guidewire med diameter S 0,014" l 0,35 mm
`Steril sproite (til skylning af systemet)
`Sterilt hepariniseret saltvand (til skylning af systemet)
`
`-
`-
`-
`-
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`KLARGGRING TIL BRUG
`1.
`Inspicer omhyggeligt GuideLinerrkateteret inden brug for
`beskadiget emballage og komponentskader
`Overidr, ved brug af sterile teknikker, udrulningsspiralen med
`GuideLiner-kateteret til det sterile omrade.
`Fiern GuideLinerrkateteret fra udrulningsspiralen, og skyl
`GuideLiner-kateterlumen grundigt fra den distale spids med
`en steril, hepariniseret saltvandsoplxzisning
`INDFQRINGSPROCEDURE
`Brug GuideLiner—Kateteret i hennold til folgende fremgangsmade
`1.
`Fastgiar den tidligere indsatte guideWire og indfor den distale
`spids af GuideLiner—Kateteret over guidewiren og fremfar
`indtil kateteret lige netop er proksimalt for hamostaseventilen
`Abn haemostaseventilen og fremfor GuideLiner-kateteret
`gennem himostaseventilen og ind |
`guide-kateteret
`For GuideLinerrkateteret under fluoroskopi torbi guider
`kateterets distale spids og ind det mnskede sted i karret.
`ADVARSEL: Far aldrig GuideLiner-kateteret ind i at kar
`med en effektiv diameter pa under 2,5 mm. Det kan give
`anledning til karskade, iskemi ogleller okKlusion. Hvis
`trykket i at kar af‘tager, nar GuideLiner-kateteret er fart
`ind, skal GuideLiner—kateteret trakkes ud, indtil trykket
`vender tilbagetil del: normals niveau.
`ADVARSEL: Pa grund af GuideLiners sterrelse og
`ikke-koniske spids skal clu vare megs: forsigtig for at
`undga Karokkluswn cg skader pa vaaggene i de kar,
`hvorigennem dette kateter passerer.
`Kontrollerved nielp af fluoroskopi, at GuideLinerrkateteret
`sidder det onskede
`sted i karret.
`Hvis der udfares en interventionel procedure, ssettes den
`interventionelle anordning over bagenden af den anbragte
`guideWIre og tremfizires gennem guiderkateteret og
`GuideLiner-kateteret og ind i det izinskede vasl<ulaare omréde
`BEMIERK: Hvis der anvendes endnu en wire under
`interventioneri, cg der meerka modstztnd i guide-
`kateteret, trakkes wiren flere centimeter tilbage cg
`fremfares langsomt igen.
`Strarn Y—adapter haemostaseventilen til pa GuideLiner-
`kateterets proksimale skaf‘t for at forhindre tilbageblzdning
`Udfwr kateterisationsproceduren. Nar proceduren er fuldfwrt
`tages G uideLinerrkateteret ud inden guiderkateteret fiernes
`fra karret.
`Kasser GuideLiner-kateteret i nenhold til hospitalels
`standardprocedurer
`OPBEVARING OG HANDTERING
`Ingen saerlige opbevarings- eller héndteringsbetingelser
`BEGRIENSET GARANTI
`Vascular Solutions LLC garanterer, at GuideLiner-kateteret ikke
`indeholder defekte materialer eller forarbeidninger inden den
`pétrykte udlzibsdato Ansvaret under denne garanti er begranset til
`refusion eller erstatning af etnvert produkt som Vascular Solutions
`LLC har konstateret har forarbeidnings- eller materialedetekter
`Vascular Solutions LLC kan ikke holdes ansvarlig for tzlger, serlige
`eller afledte skader, der skyldes brug af GuideLiner-kateteret. Skader
`pa produktet som sKyldes misbrug, andringer, forkert opbevaring
`eller torkert handtering gm, at garantien bort‘falder
`Ingen medarbeider, agent, eller distributor for Vascular Solutions
`LLC er autoriseret til at andre pa eller tiltmle til denne begraensede
`garanti pa" nogen made lngen angivelig andring ellertilfgielse kan
`glares galdende overfor Vascular Solutions LLC.
`DENNE GARANTI ERSTATTER EKSPLICIT ALLE ANDRE
`GARANTIER, UDTRYKKELIGE ELLER IMPLICI'I'I'E, INKLUSIV
`ENHVER GARANTI VEDRQRENDE SALGBARHED ELLER
`EGNETHED TIL EI' BESTEMT FORMAL, ELLER ANDRE
`FORPLIGTIGELSER FOR VASCULAR SOLUTIONS LLC.
`PATENTER 0G VIERE MlERKER
`Kan were omfattet af e: eller flere amerikanske eller
`internationale patenter.
`Se: wwwteleflex.com/patents-intv
`GuideLiner er et registreret varemaerke tilnmrende Teleflex
`Innovations S a.r |., Vascular Solutions LLC, eller Teleflex Medical
`som begge er en del afTeleflex Incorporated
`Se Ordlisten over internationale symboler pa side 27
`Se indnoldsordlisten pa side 28.
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`GuideLiner® V3 katheter
`
`Gebruiksaanwijzing
`WAARSCHUWING (VS)
`Volgens defederale wetgeving in de VS mag dit product
`uitsluitend warden verkocht door of op voorschrift van een arts.
`BESCHRIJVING VAN HET HULPMIDDEL
`De GuideLiner katheter is een snel vervvisselbare katheter met
`een enkel lumen die op een voerdraad van standaardlengte kan
`Worden geplaalst en Ieverbaar is in maten die compatibel zijn met
`geleidekatheters van 5 Fr, 6 Fr, 7 Fr en 8 Fr De grotere maten
`GuideLiner katneters zijn bedoeld voor gebruik in de proximale delen
`
`©2018 Vascular Solutions LLC
`
`3
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`103807 Rev A 06/18
`
`
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`VSIMDT00003826
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`
`Page 3
`
`Teleflex Ex. 2144
`Medtronic v. Teleflex
`IPR2020-00135
`
`

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`van het coronaire vaalstelsel ter ondersteuning van het gebruik van
`meerdere interventie-instrumenten en/ofom niervoor de mogeliikheid
`te bieden Het hulpmiddel van 150 cm heelt een roestvriistalen
`schachtgedeelte van 125 cm dat aan het distale uiteinde over een
`afstand van 17 cm is bedekt met een halve-ringvormig polymeer De
`slalen schacht wordt distaal gevolgd door een lumengedeelte van
`25 cm dat met siliconen is bestreken
`De GuideLiner katheter heett twee markeringsbanden van platinar
`iridium die voor zichtbaarneid zorgen bij gebruikvan standaard
`fluoroscopische methoden. De disiale markeringsband bevindt zich
`aan de distale tip De pr