4
Site~Rite * Needle Guide Kits and Ultrasound Probe Cover Kits Instructions For Use Kits Guide-aiguilles & Kits Enveloppes pour sonde à ultrasons Site~Rite* Mode d’emploi Site~Rite* Nadelführungs-Kits & Ultraschallsondenhüllen-Kits Gebrauchsanweisung Kit guida ago sterile e Kit coprisonda ad ultrasuoni Site~Rite* Istruzioni per l’uso Site~Rite* Kits de guías de agujas y kits de fundas para sondas de ultrasonido Instrucciones de uso Site~Rite* Naaldgeleiderkits & afdekkits voor ultrasone sondes Gebruiksaanwijzing Kits de Guias de Agulha Site~Rite* e Kits de Coberturas de Sondas de Ultra-sons Instruções de Utilização Site~Rite* Κιτ οδηγών βελονών και καλυμμάτων ανιχνευτών για υπέρηχους Oδηγνίες Xρήσης Site~Rite* Kits for nålestyring og kits for dækken af ultralydsprober Brugsanvisning Site~Rite* satser med styrnål & överdrag för ultraljudssond Bruksanvisning Site~Rite* -neulaohjainsarjat ja ultraääniluotainsuojasarjat Käyttöohjeet Site~Rite* kit for nålestyring og kit for tildekking av ultralydsonder Instruksjoner for bruk Site~Rite* Tű Vezető Készlet és Ultrahang Szonda Tasak Készlet Használati utasítás Sady vodičů jehly Site~Rite* a sady krytů ultrazvukových sond Návod k použití Site~Rite* Zestawy prowadników igieł i osłon głowic ultrasonograficznych Sposób użytkowania Site~Rite* İğne Kılavuz Takımları ve Ultrason Prob Takımları Kullanım Yönergeleri English Français Deutsch Italiano Español Nederlands Português Ελληνιχά Dansk Svenska Suomi Norsk Magyar Česky Polski Türkçe 0713994 1004R 0086

Site~Rite - C. R. Bard, Inc. · Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc naturel. Dieses Produkt und die Verpackung enthalten kein Naturlatex

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Page 1: Site~Rite - C. R. Bard, Inc. · Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc naturel. Dieses Produkt und die Verpackung enthalten kein Naturlatex

Site~Rite* Needle Guide Kits and Ultrasound Probe Cover Kits Instructions For Use

Kits Guide-aiguilles & Kits Enveloppes pour sonde à ultrasons Site~Rite*Mode d’emploi

Site~Rite* Nadelführungs-Kits & Ultraschallsondenhüllen-KitsGebrauchsanweisung

Kit guida ago sterile e Kit coprisonda ad ultrasuoni Site~Rite*Istruzioni per l’uso

Site~Rite* Kits de guías de agujas y kits de fundas para sondas de ultrasonidoInstrucciones de uso

Site~Rite* Naaldgeleiderkits & afdekkits voor ultrasone sondesGebruiksaanwijzing

Kits de Guias de Agulha Site~Rite* e Kits de Coberturas de Sondas de Ultra-sonsInstruções de Utilização

Site~Rite* Κιτ οδηγών βελονών και καλυμμάτων ανιχνευτών για υπέρηχουςOδηγνίες Xρήσης

Site~Rite* Kits for nålestyring og kits for dækken af ultralydsproberBrugsanvisning

Site~Rite* satser med styrnål & överdrag för ultraljudssondBruksanvisning

Site~Rite* -neulaohjainsarjat ja ultraääniluotainsuojasarjatKäyttöohjeet

Site~Rite* kit for nålestyring og kit for tildekking av ultralydsonderInstruksjoner for bruk

Site~Rite* Tű Vezető Készlet és Ultrahang Szonda Tasak KészletHasználati utasítás

Sady vodičů jehly Site~Rite* a sady krytů ultrazvukových sondNávod k použití

Site~Rite* Zestawy prowadników igieł i osłon głowic ultrasonograficznychSposób użytkowania

Site~Rite* İğne Kılavuz Takımları ve Ultrason Prob TakımlarıKullanım Yönergeleri

English

Français

Deutsch

Italiano

Español

Nederlands

Português

Ελληνιχά

Dansk

Svenska

Suomi

Norsk

Magyar

Česky

Polski

Türkçe

0713994 1004R 0086

Page 2: Site~Rite - C. R. Bard, Inc. · Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc naturel. Dieses Produkt und die Verpackung enthalten kein Naturlatex

ContentsContient:InhaltContenutoContenidoInhoudConteúdoΠεριεχόμεναIndholdInnehållSisältöInnholdTartalomObsahZawartośćIçindekiler

Do not reuseNe pas réutiliserNicht wiederverwenden.Non riutilizzareNo reutilizarNiet opnieuw gebruikenNão reutilizarΝα μην επαναχρησιμοποιηθείMå ikke genanvendesFår inte återanvändasÄlä käytä uudelleenIkke bruk flere gangerIsmételt felhasználása tilosNepoužívejte opakovaněNie używać powtórnieTekrar Kullanmayınız

Attention, See Instructions For UseAttention, voir le mode d’emploiAchtung! Gebrauchsanweisung beachtenLeggere attentamente le istruzioni per l’usoAtención, consulte las instrucciones de usoRaadpleeg de instructies voor gebruikAtenção, Consulte as Instruções de UtilizaçãoΠροσοχή, Συμβουλευθείτε τις Οδηγίες ΧρήσηςOBS! Se brugsanvisningenVarning, se bruksanvisningarnaHuomio! Lue käyttöohjeetOBS! Se bruksanvisningenFigyelem, lásd a használati útmutatótPozor, čtěte návod k použitíUwaga, patrz Sposób użytkowaniaDikkat, Kullanım Talimatlarına bakınız

Sterilized by Ethylene OxideStérilisé à l’oxyde d’éthylèneMit Ethylenoxid sterilisiertSterilizzato con ossido di etileneEsterilizado por óxido de etilenoGesteriliseerd met ethyleenoxideEsterilizado com óxido de etilenoΑποστειρωμένο με οξείδιο του αιθυλενίου.Steriliseret med æthylenoxidSteriliserad med etylenoxidSteriloitu etyleenioksidillaSterilisert med etylenoksidEtilén-oxiddal sterilizáltSterilizováno etylénoxidem Produkt sterylizowany tlenkiem etylenuEtilen Oksitle Sterilize Edilmiştir

Storage ConditionsConditions de stockageAufbewahrungsbedingungenCondizioni di immagazzinamentoCondiciones de almacenamientoOpslagconditiesCondićões de ArmazenamentoΣυνθήκες φύλαξηςOpbevaringsforholdLagringsförhĆllandenSäilytysehdotOppbevaringsbetingelserTárolási feltételekSkladovací podmínkyWarunki przechowywaniaSaklama Koşulları

Site~Rite* Needle Guide Set, depth(s)Kit de guide-aiguille Site~Rite*, profondeur(s)Site~Rite* Nadelführungssatz, Tiefe(n)Set Guida Ago Site~Rite*, profonditàEquipo de guía de aguja Site~Rite*, profundidad(es)Site~Rite* naaldvoerderset, diepte(n)Conjunto de agulhas-guia Site~Rite*, profundidade(s)Σετ οδηγών βελόνας Site~Rite*, βάθος(η)Site~Rite* nåleførerset, dybde(r)Site~Rite* nålguidesats (djup)Site~Rite* Neulanohjainsarja, syvyys/syvyydetSite~Rite* nålføringssett, dybde(r)Site~Rite* Tűvédő készlet, mélység(ek)Sady jehlových vodítek Site~Rite*, hloubka(y)Zestaw Site~Rite* do wprowadzania igieł, głębokość (głębokości)Site~Rite* İğne Kılavuzu Seti, derinlik(ler)

Assembled in MexicoAssemblé au MexiqueZusammengebaut in MexikoAssemblato in MessicoEnsamblado en MéxicoGeassembleerd in MexicoMontado no MéxicoΣυναρμολογείται στο ΜεξικόMonteret i MexicoMonterad i MexikoKoottu MeksikossaMontert i MexicoÖsszeszerelés helye: MexikóSmontováno v MexikuProdukt zmontowany w MeksykuMeksika'da Monte Edilmiştir

ManufacturerFabricantHerstellerProduttoreFabricanteFabrikantFabricanteКατασκευαστήςProducentTilverkareValmistajaProdusentGyártóVýrobceProducentŰretici

Sterilized by IrradiationStérilisé par irradiationDurch Bestrahlung sterilisiert.Sterilizzato per irradiazioneEsterilizado por irradiaciónMet straling gesteriliseerdEsterilizado por irradiaçãoΑποστειρωμένο με ακτινοβολίαSteriliseret ved strålingSteriliserad genom strålningSteriloitu säteilyttämälläSterilisert med strålingSugárzással sterilizálvaSterilizováno zářenímProdukt sterylizowany przez napromienianieİrradyasyon ile sterilize edilmiştir.

This product and packaging do not contain natural rubber latex.Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc naturel.Dieses Produkt und die Verpackung enthalten kein Naturlatex.Il prodotto e la confezione non contengono lattice di gomma naturale.Este producto y su embalaje no contienen látex de goma natural.Dit product en de verpakking bevatten geen natuurlijke rubberlatex.Este produto e respectiva embalagem não contêm látex de borracha natural.To παρόν πρoϊόν και η συσκευασiα δευ περιέχoυν λάτεξ από φυσικό καουτσούκ.Dette produkt indeholder ikke naturgummilatex.Denna produkt och förpackning innehåller inte naturligt gummilatex.Tämä tuote ja sen pakkaus eivät sisällä luonnonkumilateksia.Dette produktet og emballasjen inneholder ikke naturlig gummilateks.Ez a termék és csomagolása nem tartalmaz természetes gumilatexet.Výrobek a obal neobsahují prírodní kaucukový latex.Produkt i opakowanie nie zawieraja kauczuku lateksu naturalnego.Bu ürün ve ambalaj, dogal lastik lateks içermez.

This product and packaging do not contain natural rubber latex.

Do Not ResterilizeNe pas restériliserNicht resterilisieren.Non risterilizzareNo reesterilizarNiet opnieuw steriliserenNão reesterilizarΝα μην επαναποστειρωθείMå ikke resteriliseresFår inte omsteriliserasÄlä steriloi uudelleenSkal ikke resteriliseresNem újrasterilizálhatóNesterilizujte.Nie resterylizowaćTekrar Sterilize Etmeyiniz

Page 3: Site~Rite - C. R. Bard, Inc. · Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc naturel. Dieses Produkt und die Verpackung enthalten kein Naturlatex

3

The GreendotPoint vertDer Grüne PunktIl punto verdeEl punto verdeDe Groene StipPonto VerdeΑνακυκλώσιμο Svanemærket

Gröna punktenVihreä pisteSvanemerketZielony punktZöldpontZelený bodYeşil Nokta

Non-pyrogenicApyrogènePyrogenfreiApirogenoApirógenoNiet-pyrogeenApirogénicoΜη πυρετογόνοPyrogenfriIcke-pyrogenPyrogeenitonPyrogenfriNem pirogénApyrogenníProdukt niepirogennyPirojenik değildir

Non-Pyrogenic

Conductive GelGel conducteurLeitendes GelGel conduttivoGel conductorGeleidende gelGel condutorΑγώγιμη γέληLedende gelLedande gelJohtava geeliLedende gelKonduktív gélVodivý gelŻel przewodzącyİletken Jel

Rx Only

xNeedle guide gauge sizeCalibre du guide-aiguilleGröße der NadelführungMisura calibro guida agoTamaño del calibre de al guía de agujaNaaldvoerdermaatTamanho do medidor de agulhas-guiaΔιάμετρος (G) οδηγού βελόναςNålefører målstørrelseNålguide (diameter)Neulanohjaimen kokomittaStørrelse på nålføringTűvédő méreteVelikost gázy jehlového vodítkaRozmiar prowadnicy igłyİğne kılavuzu kalibre boyutu

X

Probe cover length. Probe cover with 2 elastic bands.Longueur du protège-sonde. Protège-sonde avec 2 élastiques.Länge der Sondenhülle. Sondenhülle mit 2 Gummibändern.Lunghezza cuffia sonda. Cuffia sonda a doppia banda elastica.Longitud de la tapa de la sonda. Tapa de sonda con 2 bandas elásticas.Lengte sondeafdekking. Sondeafdekking met 2 elastische banden.Comprimento da tampa da sonda. Tampa da sonda com 2 elásticos.Μήκος καλύμματος ανιχνευτή. Κάλυμμα ανιχνευτή με 2 ελαστικές ταινίες.Probecover længde. Probecover med 2 elastiske bånd.Sondöverdragslängd. Sondöverdrag med två gummiband.Anturin suojuksen pituus. Anturin suojus ja 2 kuminauhaa.Probedeksellengde. Probedeksel med 2 elastiske bånd.Szonda fedelének hossza. Szonda fedele 2 rugalmas szalaggal.Délka krytu sondy. Kryt sondy s 2 elastickými pásky.Długość osłony sondy. Osłona sondy z 2 elastycznymi opaskami.Prob kılıfı uzunluğu. 2 elastik bantlı prob kılıfı.

PolyethylenePolyéthylènePolyethylenPolietilenePolietilenoPolyethyleenPolietilenoΠολυαιθυλένιοPolyethylenPolyetenPolyeteeniPolyetylenPolietilénPolyetylenPolietylenPolietilen

PolyurethanePolyuréthanePolyurethanPoliuretanoPoliuretanoPolyurethaanPoliuretanoΠολυουρεθάνιοPolyurethanPolyuretanPolyuretaaniPolyuretanPoliuretánPolyuretanPoliuretanPoliüretan

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.La loi fédérale (E.-U.) n’autorise la délivrance de ce système qu’à un médecin ou sur prescription d’un médecin.Gemäß den US-Bundesgesetzen darf dieses Produkt nur von einem Arzt oder auf Anordnung eines Arztes verkauft werden.In base alla legge federale (U.S.A.) La vendita di questo dispositivo è consentita solo da parte o su prescrizione di un medico.La ley federal (EE.UU.) limita la venta de este dispositivo, que debe ser realizada por un médico opor prescripción facultativa.Krachtens de federale wetgeving (VS) mag dit instrument uitsluitend door of op voorschrift van een arts worden verkocht.As Leis Federais dos E.U. determinam que este dispositivo seja vendido somente por médicos ou por ordem destes.Τo Ομoσπoνδιακό Δίκαιo των Η.Π.Α. περιορίζει την πώληση από γιατρούς γιατρού.Føderal lov i USA begrænser denne anordning til salg af eller på bestilling af en læge.Enligt federal lagstiftning (USA) får denna produkt säljas endast av läkare eller enligt läkares ordination.Yhdysvaltain lain mukaan tätä tuotetta saa myydä vain lääkäri tai lääkärin määräyksestä.Etter amerikansk lovgivning kan dette utstyret kun selges eller ordineres av en lege.Ezen eszköz kizárólag orvos által, illetve orvosi rendelvényre értékesíthető, az Egyesült Államok vonatkozó szövetségi törvénye értelmében.Federálni zákony USA omezují prodej tohoto zařízení jen na prodej na objednávku lékaře.Zgodnie z prawem federalnym (w USA) urządzenie to może być sprzedawane wyłącznie przez lekarzy lub na ich zlecenie.A.B.D. Federal Yasalarına göre bu cihaz bir hekim tatafından veya izniyle satılabilir.

Sterile,Non-Pyrogenic

Unless Package isDamaged or Opened.

Do not use if package is damagedNe pas utiliser si l’emballage est endommagéNicht verwenden, wenn die Verpackung beschädigt istNon utilizzare se la confezione è danneggiataNo usar si el envase está dañadoNiet gebruiken wanneer de verpakking beschadigd isNão utilizar se a embalagem estiver danificadaΜην χρησιμοποιείτε το προϊόν εάν η συσκευασία του έχει υποστεί ζημιάMå ikke anvendes, hvis emballagen er beskadigetAnvänd inte produkten om förpackningen är skadadÄlä käytä, jos pakkaus on vaurioitunutMå ikke brukes dersom pakningen er skadetA készüléket ne használja, ha a csomagolása megsérültNepoužívejte, pokud je obal poškozenNie używać, jeśli opakowanie jest uszkodzonePaket hasarlıysa kullanmayınız

PE PU

Page 4: Site~Rite - C. R. Bard, Inc. · Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc naturel. Dieses Produkt und die Verpackung enthalten kein Naturlatex

4

ENGLISH

Site~Rite* Needle Guide Kits & Ultrasound Probe Cover KitsIntended UseThe Site~Rite* Needle Guides and Probe Cover Kits are intended to be used with Site~Rite* Ultrasound System probes.

Indications for Use• Site~Rite* Needle Guide Kits provide guidance for a needle to intersect an ultrasound beam at a

fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.

• Site~Rite* Needle Guide Kits and Probe Cover Kits provide a protective covering to sheath an ultrasound transducer and isolate a site of surgical penetration from microbial and other contami-nation.

Warnings• Useonlysterile,legallymarketedplasticprobecoversthatare1mil(0.001inchor0.0254mm)thick.• Neveruseprobesthatareoutofalignmentforneedleguidance.

Precautions• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.• Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk of patient or

user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.• Onlyapplycommerciallyavailableultrasoniccouplant,whichhasbeenspecificallyformulatedfor

use in medical applications, to the acoustic window (or face) of the probe.• Usewaterorrubbingalcoholandasoftclothtoremovecouplantfromtheacousticwindow(or

face) of the probe. Failure to do so may scratch the acoustic window.• Donotallowultrasoniccouplanttodryontheacousticwindow(orface)oftheprobe.Ifthecou-

plant should dry, use water or rubbing alcohol and a soft cloth to remove it. Never use a tool of any kind to remove dry couplant from the acoustic window (or face) of the probe.

• Somecommerciallyavailableprobecoverscontainlatex.Naturalrubberlatexmaycauseallergicreactions. Refer to the US FDA alert titled: “Medical Alert: Allergic Reactions to Latex-Containing Medical Devices”. Site~Rite* Needle Guide Kits and Ultrasound Probe Cover Kits do not contain natural rubber latex.

• Alwayssnaptheneedleguidesontotheprobehook.Donotslidetheneedleguideontotheneedle guide hook, as the sterile sheath may tear.

Note: For Site~Rite* Ultrasound System warnings and precautions, refer to the applicable Site~Rite* Ultrasound System instructions for use.

Site~Rite* Needle GuidesSite~Rite* Needle Guides attach to the needle guide hook located on the probe. Site~Rite* Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist in placing the tip of the needle in a specific structure.

1— UltrasoundPlane:Theultrasoundimagingarea.

2— IntersectionDepth:Whenplacedthroughaneedleguide, the needle will intersect the ultrasound plane at the depth indicated on the needle guide.

3— Exampletargetstructure

Draping the Probe for Sterile UseWhen using Site~Rite* Ultrasound System probe in a sterile environment, the probe and part of the probe cable must be covered with a sterile, acoustically transparent plastic sheath.Warning:Useonlysterile,legallymarketedplasticprobecoversthatare1mil(0.001inchor0.0254mm) thick.Caution: Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to the US FDA alert titled: “Medical Alert: Allergic Reactions to Latex-Containing Medical Devices”,issuedMarch29,1991.Site~Rite* Needle Guide Kits and Ultrasound Probe Cover Kits do not contain natural rubber latex.

To drape the probe for sterile use:

1. Cleananddisinfectprobe.RefertoSite~Rite* Ultrasound System Instructions for Use.

2. Place the probe in the side arm probe holder on the roll stand.

3. Apply a layer of non-sterile ultrasonic coupling gel on the acoustic window of the probe head.

4. Ensuretheprobecoverisfullyrolledup.5. Placetheprobecoverovertheprobehead,being

careful not to wipe off the coupling gel. 12 in. (30.5 cm)

96 in. (244 cm)

A

B

C

6. Cover the probe and cable with the probe cover.7. Smooth the probe cover over the acoustic window of the probe to remove any air bubbles or

folds in the probe cover.8. Secure probe cover with provided fasteners.9. If a second probe cover is provided, follow steps 2-6 to apply. Ensure gel is applied between all

layers of probe covers to assure good acoustic transmission.10. Applyalayerofsterilecouplinggeltothecoveredacousticwindow.11. Discardprobecoversafteruse,followinghospitalprocedures.

Attaching the Needle Guide to the ProbeTo attach the needle guide to the probe:1. Choosetheappropriateneedleguidebasedontheneedlegaugeandthedepthofthetarget

structure.2. Ensure that a sterile probe cover has been placed over the probe.

See Draping the Probe for Sterile Use. 3. Clip the short end of the needle guide to the end

of the needle guide hook closest to the top of the probe.

4. Pushthelargerendoftheneedleguidetowardthe probe until the needle guide snaps on to the needle guide hook. Do not slide.

Caution: Always snap the needle guide on to the probe hook. Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear.

Using the Needle Guides for Vascular Access

1. Slidetheappropriatelysizedneedle,bevelededge facing the probe, into the channel on the guide.

2. Place the probe against the skin, perpendicu-lar to the target structure.

3. Hold the probe so that the needle guide points away from the heart.

4. Centerthedotmarkersonthetargetves-sel. The dot markers are displayed on the Site~Rite* Ultrasound System screen.

5. Whilekeepingthedotmarkerscenteredonthetargetvessel,slowly advance the needle while looking at the screen of the Site~Rite* Ultrasound System. When the needle approaches the target vessel, you should see the anterior wall indenting. Once puncture occurs, the vessel returns to normal shape.

6. Hold the needle, then gently rock the probe away from the needle for a smooth separation. The needle guide channel opens, and the needle smoothly disengages from the guide.

Bard Access Systems, Inc. warrants to the original purchaser that this product will be free from defects in materialandworkmanshipforaperiodofone(1)yearfromthedateofpurchase.Ifthisproductprovesto be so defective, purchaser may return same to Bard Access Systems, Inc. for repair or replacement, at Bard Access Systems, Inc.’s option. All returns must be authorized in advance in accordance with Bard Access Systems, Inc.’s Returned Goods Policy found in its then current Price List. The liability of Bard Access Systems, Inc. under this limited product warranty does not extend to any abuse or misuse of this product or its repair by anyone other than an authorized Bard Access Systems, Inc. representative.

THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED (INCLUDING, WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). THE LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF BARD ACCESS SYSTEMS, INC. AND REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND BARD ACCESS SYSTEMS, INC. WILL NOT BE LIABLE TO PURCHASERS FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF ITS HANDLING OR USE.

*Bard and Site~Rite are trademarks and/or registered trademarks of C. R. Bard, Inc.

©2010 C. R. Bard, Inc. All rights reserved.

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MANUFACTURER: Bard Australia Pty Ltd ABN 50 001 468 935 22 Lambs Road, Artarmon, NSW2064Australia Ph+61 2 8875 4000 Fax+61 2 8875 4050