0459
VenaTech®LP
!
Brachial Introducer System (Antecubital)
[For US market only: Vena Cava Filter
Brachial Introducer System (Antecubital)]
REF. 04439985
ENGLISH
FRANÇAIS
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DEUTSCH
ESPAÑOL
en
fr
de
es
B
ITALIANO
SVENSKA
PORTUGUÊS
NORSK
DANSK
SUOMI
POLSKI
EΛΛHNIKA
TÜRKÇE
CESKY JAZYK
MAGYAR
it
sv
pt
no
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fi
pl
el
tr
cs
hu
!
LOT
STERILE EO
SYMBOLS GLOSSARY
en: Brachial approach
fr: Voie brachiale
de: Brachialer Zugang
es: Abordaje Braquial
it: Approccio Brachiale
sv: Brakial metod
pt: via braquial
no: Brakial implantasjon
da: Brachial adgang
fi: Laittaminen brachialisesti
pl: Dostęp ramienny
el: Βραχιόνια προσπέλαση
tr: Brakial giriş
cs: Brachiální přístup
hu: Brachialis megközelítésből
en: Batch code
fr: Numéro de lot
de: Chargencode
es: Número de lote
it: Numero di lotto
sv: Batchnummer
pt: Código de lote
no: Batch (produksjonsserie) kode
da: Batch kode
fi: Eränumero
pl: Numer serii
el: Κωδικός παρτίδας
tr: Lot no
cs: Číslo šarže
hu: LOT szám
en: Caution, consult accompanying documents
fr: Attention, consulter les documents d‘accompagnement
de: Achtung! Siehe beiliegende Dokumente.
es: Atención, consultar documentación adjunta
it: Attenzione, consultare le istruzioni per l’uso
sv: Varning, konsultera medföljande dokument
pt: Atenção, consultar documentos inclusos
no: OBS! Slå opp i vedlagte dokumenter
da: Forsigtighed, se vedlagte dokumenter
fi: Lue käyttöohje
pl: Ostrzeżenie, sprawdzić towarz yszące dokumenty
el: Προσοχή, διαβάστε τα συνοδευτικά εγχειρίδια
tr: Dikkat, ürün ile birlikte verilen dökümanlara bak ınız.
cs: Pozor, viz přiložená dokumentace
hu: Figyelmesen olvassa el a mellékelt tájékoztatót
en: Sterilized using ethylene oxide
fr: Stérilisé en utilisant de l’oxyde d‘éthylène
de: Sterilisation mit Ethylenoxid
es: Esterilización mediante Óxido de Etileno
it: Sterilizzato con Ossido di Etilene
sv: Steriliserad med ethylenoxid
pt: Esterilizado por óxido de etileno
no: Sterilisert med etylen oksyd
da: Ethylenoxid steriliseret
fi: Sterıloıntımenetelmänä etyleenıoksıdı
pl: Sterylizowany prz y użyciu tlenku etylenu
el: Αποστείρωση με αιθυλενοξείδιο
tr: Etilen oksit ile sterilize edilmiştir.
cs: Sterilizováno ethylenoxidem
hu: Ethylen oxid-al sterilizált
en: Use by date
fr: À utiliser avant la date
de: Verwendbar bis
es: Fecha de caducidad
it: Data di scadenza
sv: Används före
pt: Utilizar até
no: Brukes innen
da: Anvendes inden
fi: Käytettävää ennen
pl: Data ważności
el: Ημερομηνία λήξης
tr: Son kullanma tarihi
cs: Použitelné do
hu: Lejárati idő
en: Manufacturer
fr: Fabricant
de: Hersteller
es: Fabricante
it: Fabbricante
sv: Tillverkare
pt: Fabricante
no: Fabrikant
da: Producent
fi: Valmıstaja
pl: Producent
el: Οίκος κατασκευής
tr: Üretici
cs: Výrobce
hu: Gyártó
VenaTech®LP
Brachial Introducer System (Antecubital)
[For US market only: Vena Cava Filter
Brachial Introducer System (Antecubital)]
REF. 04439985
Instructions for use for implantation
brachial approach
via the
Use this document only if you have chosen to implant
the VenaTech® LP filter from the Brachial approach (Antecubital).
Do not use these instructions for use for any other approach
or for the implantation of any other vena cava filter.
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1
INTRODUCTION
The VenaTech® LP Brachial Introducer System (Antecubital) must be used with a
VenaTech® LP vena cava filter only.
The VenaTech® LP Brachial Introducer System (Antecubital) includes a 96 cm long
(37.8 in.) sheath, designed to be used during the implantation of a VenaTech® LP
vena cava filter via the Brachial approach (Antecubital).
Please refer to the VenaTech® LP instructions for use booklet (JUGULAR, or
SUBCLAVIAN for OUS only, approaches) for information about the use of a
VenaTech® LP vena cava filter.
SYSTEM CONTENTS
• 7F I.D. Introducer sheath with hemostasis valve and side connection
• 7F Dilator
• 7F Long Pusher (white)
• 7F Short Pusher (blue)
• PTFE coated “J” guide, length = 180cm, diameter = 0.89mm (0.035 in)
For an implantation of a VenaTech® LP vena cava filter from the Brachial approach
(Antecubital), it is mandatory to use the above-mentioned accessories, instead of
the accessories available into the VenaTech® LP vena cava filter kit. The only items
that must be used from the VenaTech® LP vena cava filter kit are the following :
• Filter in its cartridge
• Cartridge cradle
• Instructions for use (JUGULAR, or SUBCLAVIAN for OUS only, approaches)
2
INDICATIONS
The VenaTech® LP Brachial Introducer system (Antecubital) is intended for use
with the VenaTech® LP Vena Cava Filter.
IMPLANTATION PROCEDURE
Please refer to the VenaTech® LP instructions for use booklet (JUGULAR, or
SUBCLAVIAN for OUS only, approaches) for important warnings / indications /
contraindications / implantation procedure of the VenaTech® LP Brachial
Introducer System (Antecubital). [For US market only: Vena Cava Filter Brachial
Introducer System (Antecubital)]
Note for the implantation from the Brachial approach :
• Implantation approach:
This Introducer System is designed for insertion via the Brachial approach
(Antecubital). If needed, this Introducer System can be used to insert the
filter via the right internal jugular vein or the left or right subclavian veins.
In this case, due to the length of the introducer, it is important to rigorously
follow aseptic technique.
Other approaches (particularly the left internal jugular vein, the right or
left external jugular veins) should not be attempted.
• Preparation of the patient:
Stretch the arm of the patient 90 degrees from the long axis of
the spinal column. This will allow you to place the introducer in the axis
of the subclavian vein.
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PRECAUTIONS
During the implantation via the Brachial approach (Antecubital) the filter cartridge
must be inserted in the JUGULAR position into the cartridge cradle.
3
Introducer system for use with VenaTech® LP vena cava filter for permanent
interruption of the Inferior Vena Cava. STERILE and non-pyrogenic, sterilized using
Ethylene Oxide. Contents of unopened, undamaged package are sterile and non-pyrogenic. For single use only. The device and its accessories are not re usable nor
designed to be re-used. Any re-use would definitely compromise the performance and
safety of the device. Destroy system components after filter implantation.
Components may not be cleaned, resterilized or reused. Store at room temperature.
Avoid freezing and excessive heat. Do not remove from unit carton until ready for use.
Caution : Federal (U.S.A.) Law restricts this device to sale by or on the order of a
physician.
Opening the sterile packaging :
Confirm the date of sterile expiration on the labelling. Never use an introducer
system which has exceeded its sterile expiration date. To maintain sterility, all
normal operating room sterile procedures should be followed.
VenaTech®LP
Brachial Introducer System (Antecubital)
REF : 04439985
B. Braun Medical
204, avenue du Maréchal Juin
BP 331
92107 Boulogne Cedex
FRANCE
Information :
Fax : 33 5 49 52 88 77
4
(1) fr: Pour le marché américain uniquement : Système d'introducteur
Brachial (Antécubital) de filtre de veine cave
de: Nur für den US Markt: Vena Cava Filter Brachiales
Einführbesteck (Ellenbeuge)
es: Solo para el mercado de EUA: Sistema introductor Braquial del
Filtro de Vena Cava (Antecubital)
it: Solo per il mercato USA: Sistema per introduzione Brachiale
(Antecubitale) del Filtro per Vena Cava
sv: Endast för amerikanska marknaden: Vena Cava filter brakialt
introducer system (antekubitalt)
pt: Exclusivamente para o mercado EUA: Sistema de introdução
para filtro de veia cava braquial (antecubital)
no: Kun for US markedet: Vena Cava Filter Brakial Introducer System
(antecubital)
da: Kun til brug i USA: Vena Cava Filter Branchial introducerings
system, (Antecubital)
fi: Vain USA:n markkinoille : Vena Cava suodatin brachial
sisäänvientiväline (Antecubital)
pl: Wyłącznie dla rynku Stanów Zjednoczonych: system do
wprowadzania filtra z dostępu ramiennego (zgięcie łokciowe)
el: Μόνο για την αγορά των ΗΠΑ: Σύστημα Βραχιόνιας Εισαγωγής
(Αντιβράχιο) φίλτρου κοίλης φλέβας
tr: Sadece Amerika Birleşik Devletleri pazarı için: Vena Cava Filtre
Brakial Girişim Sistemi (Antekubital)
cs: Určeno pouze pro prodej v USA: zaváděcí sytém Vena Cava
Filter (antekubitální)
hu: Kizárólag az amerikai piacra: Vena Cava Filter Brachial bevezető
rendszerrel (Antecubital)
(2) fr: Pour le marché américain uniquement
de: Nur für den US Markt
es: Solo para el mercado de EUA
it: Solo per il mercato USA
sv: Endast för amerikanska marknaden
pt: Exclusivamente para o mercado EUA
no: Kun for US markedet
da: Kun til brug i USA
fi: Vain USA:n markkinoille
pl: Wyłącznie dla rynku Stanów
Zjednoczonych
el: Μόνο για την αγορά των ΗΠΑ
tr: Sadece Amerika Birleşik Devletleri
pazarı için
cs: pouze pro prodej v USA
hu: Kizárólag az amerikai piacra.
(3) fr: Fabriqué pour
de: Hergestellt von
es: Fabricado por
it: Prodotto da
sv: Tillverkad för
pt: Fabricado para
no: Produsert for
da: Produceret for
fi: Valmistettu
pl: Wyprodukowano dla
el: Κατασκευάζεται για την
tr: Aşağıdaki için üretilmiştir
cs: Vyrobeno pro
hu: Gyátrtott.
(4) fr: Service clients, commande
de: Kundendienst, Bestellung
es: Gestión de Clientes, pedidos
it: Servizio Clienti, ordini
sv: Kundservice, beställning
pt: Serviço de clientes, encomendas
no: Kundeservice, bestilling
da: Kundeservice, bestilling
fi: Asiakaspalvelu, tilauksia
pl: Obsługa klienta, zamówienia
el: Εξυπηρέτηση πελατών, παραγγελίες
tr: Müşteri Servisi, sipariş
cs: Zákaznický servis, objednávky
hu: Vevőszolgálat, megrendelés
(5) fr: Support technique
de: Technische Beratung
es: Soporte Técnico
it: Supporto tecnico
sv: Teknisk support
pt: Apoio Técnico
no: Teknisk support
da: Teknisk support:
fi: Tekninen tuki
pl: Wsparcie techniczne
el: Τεχνική Υποστήριξη
tr: Teknik destek
cs: Technická podpora
hu: Technikai támogatás.
VenaTech®LP
0459
Brachial Introducer System (Antecubital)
REF: 04439985
For US market only:
Manufactured for:
B. Braun Interventional Systems Inc.
824 Twelfth Avenue
Bethlehem, PA 18018
www.bisusa.org
Customer Service, ordering:
Tel: (877) VENA-CAV (836-2228)
Fax: (610) 849-1334
Technical support:
Tel: (800) 443 - VENA (8362)
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(5)
B. Braun Medical
204, avenue du Maréchal Juin
BP 331
92107 Boulogne Cedex
FRANCE
Information:
Fax: 33 5 49 52 88 77
F1944 Ed. 02 (03/2014)
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