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Tumark
Professional X for Brevera
TUMARK-BREV-P-X
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Tumark
Professional X for Brevera
TUMARK-BREV-S-X
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Tumark
Professional X for Eviva
TUMARK-E13-P-X
®
Tumark
Professional X for Eviva
TUMARK-E13-S-X
Article No.: 999824V7
INSTRUCTIONS FOR USE
GEBRUIKSAANWIJZING
CONSIGNES D'UTILISATION
GEBRAUCHSANWEISUNG
ISTRUZIONI PER L'USO
INSTRUÇÕES DE USO
INSTRUCCIONES DE USO
®
Petite
®
Standard
®
Petite
®
Standard
X
© 2020-03
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Related Manuals for Hologic Tumark Professional X
Summary of Contents for Hologic Tumark Professional X
- Page 1 ® ® Tumark Professional X for Brevera Petite TUMARK-BREV-P-X ® ® Tumark Professional X for Brevera Standard TUMARK-BREV-S-X ® ® Tumark Professional X for Eviva Petite TUMARK-E13-P-X ® ® Tumark Professional X for Eviva Standard TUMARK-E13-S-X INSTRUCTIONS FOR USE GEBRUIKSAANWIJZING CONSIGNES D'UTILISATION GEBRAUCHSANWEISUNG ISTRUZIONI PER L’USO...
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Page 3: Table Of Contents
E13-S-X Eviva 1213-20 (Standard) * Biopsy device is sold with compatible biopsy introducer ® ® ** Tumark Professional X for Eviva Standard and Tumark Professional X for Eviva Petite are not ® compatible with Eviva 10 cm biopsy devices 1/32... -
Page 4: English - Instructions For Use
Eviva 1213-20 (Standard) * Biopsy device is sold with compatible biopsy introducer ® ® ** Tumark Professional X for Eviva Standard and Tumark Professional X for Eviva Petite are not ® compatible with Eviva 10 cm biopsy devices Important Information: Read the instruction manual thoroughly and be familiar with its contents prior to use. - Page 5 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Warnings: Consult instructions for use of the biopsy device. Only qualified physicians with knowledge, experience and training in percutaneous soft tissue marking should use the product. This manual does not include descriptions or instructions for surgical techniques.
- Page 6 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Device description: The product is a sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker (1), an introducer cannula (2) and a plastic handheld applier (4) with deployment mechanism.
- Page 7 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Under the scanning conditions defined above, it is expected that clip marker of ® ® ® Tumark Professional X for Eviva and Tumark Professional X will produce the following image artefacts: at 1.5 Tesla: 4.7 mm spin echo sequence;...
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Page 8: Nederlands - Gebruiksaanwijzing
Eviva 1213-20 (Standaard) * Het biopsieapparaat wordt verkocht met de compatibele biopsie-inbrenger ® ® ** Tumark Professional X for Eviva Standard en Tumark Professional X for Eviva Petite zijn niet ® compatibel met Eviva biopsieapparaat 10 cm Belangrijke informatie: Lees voor gebruik de gebruikshandleiding grondig en zorg dat u vertrouwd bent met de inhoud. - Page 9 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Waarschuwingen: Raadpleeg de gebruiksinstructies voor gebruik van het biopsieapparaat. Enkel gekwalificeerde artsen met kennis, ervaring en opleiding in percutane markering van zacht weefsel mogen dit product gebruiken. Deze handleiding bevat geen beschrijvingen of instructies voor chirurgische ...
- Page 10 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Beschrijving van het apparaat: Het product is een steriel, vooraf geladen weefselmarkeringssysteem voor enkel gebruik dat bestaat uit een niet-absorberende nikkel-titanium marker (1), een inbrengcanule (2) en een plastic aanbrenger (4) met aanbrengmechanisme. De aanbrenger heeft een botte top en kan enkel samen met een inbrenger worden gebruikt.
- Page 11 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Onder de hierboven gedefinieerde omstandigheden voor het scannen, wordt ® ® ® verwacht dat clip-markeringen van Tumark Professional X for Eviva en Tumark Professional X de volgende beeldartefacten zullen produceren: bij 1,5 Tesla: 4,7 mm spin-echosequentie;...
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Page 12: Français - Consignes D'utilisation
F R A N Ç A I S - C O N S I G N E S D ' U T I L I S A T I O N Lire les instructions avant utilisation À conserver pour consultation ultérieure Tableau de compatibilité : Tableau de compatibilité des appareils de biopsie Hologic : Com- Appareil de biopsie Système d’application des marqueurs patible Réf.:... - Page 13 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Mise en garde : Reportez-vous aux consignes d’utilisation de l’appareil de biopsie. Seul un médecin qualifié et possédant une connaissance, une expérience et une ...
- Page 14 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Description de l'appareil : Ce produit est un système stérilisé et pré-chargé de marquage des tissus à usage unique. Il est composé d’un marqueur en nickel-titane non-absorbable (1), d’une canule d'introduction (2) et d’un applicateur à...
- Page 15 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera ® Dans les conditions d’imagerie définies ci-dessus, le clip de repérage du Tumark ® ® ® Professional X for Eviva et Tumark Professional X for Brevera devrait produire les artefacts d'image suivants : à...
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Page 16: Deutsch - Gebrauchsanweisung
E13-S-X Eviva 1213-20 (Standard) * Das Biopsiegerät wird mit einer kompatiblen Schleuse verkauft. ** Tumark Professional X for Eviva ® Standard und Tumark Professional X for Eviva ® Petite sind ® nicht mit Eviva 10 cm Biopsiegeräten kompatibel. Wichtiger Hinweis: Lesen Sie diese Gebrauchsinformation vor der Verwendung des Produktes sorgfältig... - Page 17 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Warnhinweise: Gebrauchsanweisung des Biopsiegerätes zu Rate ziehen. Die Verwendung des Produktes sollte nur durch qualifizierte Ärzte mit entsprechenden Kenntnissen, Erfahrungen Training perkutaner Markierung in Weichteilgewebe erfolgen. Diese Gebrauchsinformation enthält keine Beschreibungen oder Anleitungen für ...
- Page 18 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Gerätebeschreibung: Das Produkt ist ein steriles, vorgeladenes Einwegsystem zur Markierung von Gewebebereichen. Es besteht aus einem nicht resorbierbaren Nickel-Titan-Marker (1), einer Kanüle (2) zur Platzierung und einem Kunststoffgriff (4) mit Auswurfmechanismus.
- Page 19 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Unter den oben definierten Scan-Bedingungen wird erwartet, dass die Clipmaker von ® ® ® ® Tumark Professional X for Eviva und Tumark Professional X for Brevera maximal folgende Bildartefakte erzeugen: ...
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Page 20: Italiano - Istruzioni Per L'uso
I T A L I A N O - I S T R U Z I O N I P E R L ’ U S O Leggere le istruzioni prima dell’uso Conservare per consultazione futura Tabelle di compatibilità: Tabella di compatibilità dei dispositivi per biopsia Hologic: Com- Dispositivo per biopsia Sistema di applicazione del marcatore... - Page 21 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Avvertenze: Consultare le istruzioni per l’uso del dispositivo per biopsia. L’uso del prodotto è riservato ai soli medici qualificati con conoscenza, esperienza e formazione in marcatura percutanea di tessuti molli. Questo manuale non include descrizioni o istruzioni relative a tecniche ...
- Page 22 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Descrizione del dispositivo: Il prodotto è un sistema precaricato di marcatura del sito del tessuto che comprende un marcatore in nichel-titanio non assorbibile (1), una cannula introduttrice (2) e un applicatore in plastica portatile (4) con un meccanismo di impianto.
- Page 23 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Non esporre il marcatore a clip impiantato a tecniche di RMI non convenzionali e non standardizzate, diverse da quelle elencate qui sopra, in quanto NON È STATO TESTATO per tali scopi.
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Page 24: Português - Instruções De Uso
* O dispositivo de biópsia é vendido com um introdutor de biópsia compatível ® ® ** O Tumark Professional X for Eviva Standard e o Tumark Professional X for Eviva Petite não ® são compatíveis com os dispositivos de biópsia Eviva 10 cm Informação importante:... - Page 25 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Avisos: Consulte as instruções para uso do dispositivo de biópsia. Apenas médicos devidamente habilitados com os conhecimentos, experiência e formação em marcação de tecidos moles percutâneos devem usar o produto. Este manual não inclui descrições ou instruções para técnicas cirúrgicas.
- Page 26 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Descrição do dispositivo: O produto é um sistema de marcação de local de tecido pré-carregado, estéril, de uso único,constituído por um marcador de níquel-titânio não absorvível (1), uma cânula introdutora (2) e um aplicador manual de plástico (4) com mecanismo de implantação.
- Page 27 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera ® Nas condições de exame acima definidas, espera-se que o clipe marcador Tumark ® ® ® Professional X for Eviva e Tumark Professional X for Brevera produza os seguintes artefactos de imagem: a 1,5 T: sequência spin eco de 4,7 mm;...
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Page 28: Español - Instrucciones De Uso
E S P A Ñ O L - I N S T R U C C I O N E S D E U S O Lea las instrucciones antes de su uso Guárdelas para referencias futuras Tabla de compatibilidad: Gráfico de compatibilidad de los dispositivos de biopsia de Hologic Com- Dispositivo de biopsia Sistema de Aplicación del marcadores... - Page 29 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Advertencias: Consulte las instrucciones de uso del dispositivo de biopsia. Solo médicos cualificados con conocimiento, experiencia y capacitación en marcación percutánea de tejido blando deben utilizar el producto. ...
- Page 30 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Descripción del dispositivo: El producto está indicado para la marcación de tejido. Es un sistema de uso único y esterilizado, precargado con un marcador de níquel-titanio no absorbible (1), que cuenta con una cánula introductora (2) y un aplicador manual de plástico (4) con mecanismo de implantación del marcador.
- Page 31 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera Con arreglo a las condiciones de escaneo definidas anteriormente, se prevé que el ® ® ® marcador de clip de Tumark Professional X for Eviva y el Tumark Professional X ®...
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Page 32: Symbols
® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera S Y M B O L S SYMBOOLS / SYMBOLES / SYMBOLE / SIMBOLI / SÍMBOLOS / SÍMBOLOS: ENGLISH NEDERLANDS FRANÇAIS Caution Attentie Prudence Raadpleeg de Consult instructions for use Respecter le mode d'emploi gebruiksinstructies... - Page 33 ® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera DEUTSCH ITALIANO PORTUGUÊS ESPAÑOL Achtung Attenzione Aviso Precauciones Siga las Gebrauchsanweisung Seguire le istruzioni Siga as instruções instrucciones de beachten per l'uso de utilização Artikelnummer Numero prodotto Número do artigo Número de artículo...
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Page 34: Ordering
® ® ® ® Tumark Professional X for Eviva & Tumark Professional X for Brevera O R D E R I N G BESTELLEN / COMMANDE / BESTELLUNG / PER ORDINAZIONE / ENCOMENDAR / PARA PEDIDOS: Name Length Naam / Nom / Bezeichnung / Lengte / Longueur / Länge / Lung- hezza / Longitud / Comprimento Nome / Nome / Nombre... - Page 36 Distributed by: Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Phone: 877-371-4372 email: mammosupport@hologic.com www.hologic.com SOMATEX Medical Technologies GmbH Hohenzollerndamm 150 / 151 14199 Berlin Germany 999824V7 2020-03...
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