En Instructions For Use; Product Description; General Information And Warnings - PFM Medical Multi-Snare Instrucciones De Uso

Do not use if packaging is damaged // Bei beschädigter Verpackung nicht verwenden // Ne pas utiliser si l'emballage
est endommagé // No usarlo si el embalaje está dañado // Non utilizzare se la confezione risulta danneggiata //
Niet gebruiken indien de verpakking beschadigd is // Nunca utilize se a embalagem estiver danificada // Använd
inte om förpackningen är skadad // Μην το χρησιμοποιείτε εάν η συσκευασία είναι χαλασμένη // Ambalajın hasarlı
olması halinde kullanmayınız // Nepoužívejte v případě poškození obalu // Sérült csomagolás esetén ne használja a
terméket // Не использовать, если упаковка повреждена // Nie stosować w przypadku uszkodzenia opakowania //
‫ال تستخدم المنتج إذا كانت العبوة تالفة‬
Manufacturer // Hersteller // Fabricant // Fabricante // Produttore // Fabrikant // Fabricante // Tillverkare //
Κατασκευαστής // Üretici // Výrobce // Gyártó // Изготовитель // Producent // ‫جهة التصنيع‬
Latex free // Latex-frei // Sans latex // Sin látex // Non contiene lattice // Latex-vrij // Isento de látex // latexfri //
Χωρίς λάτεξ // Lateks içermez // Neobsahuje latex // Latexmentes // Не содержит латекса // Nie zawiera lateksu //
LATEX
‫خال ٍ من الالتكس‬
Diethylhexylphthalate (DEHP) free // Diethylhexylphthalat-(DEHP-)frei // Sans diéthylhexylphtalate (DEHP) // Sin
DEHP dietilhexilftalato (DEHP) // Non contiene dietilesilftalato (DEHP) // Zonder diethylhexylftalaat (DEHP) // Isento de
dietilhexilftalato (DEHP) // fri från dietylhexylftalat (DEHP) // Χωρίς δι(2-εθυλεξυλ) φθαλικό εστέρα (DEHP) // Dietil
heksilftalat (DEHP) içermez // Neobsahuje diethylhexylftalát (DEHP) // Dietilén-ftalátot (DEHP) tartalmaz // Не
содержит диэтилгексилфталат (ДЭГФ) // Nie zawiera DEHP // (DEHP) ‫خال ٍ من ثنائي إيثيل هيكسيل الفثاالت‬
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. // Hinweis: Laut Bundesge-
setzgebung der USA ist die Verwendung dieses Produkts nur durch einen Arzt gestattet // Remarque : Selon la légis-
lation fédérale américaine, l'utilisation de ce produit est autorisée uniquement par un médecin // Nota: La norma-
tiva federal vigente (EE.UU.) limita el uso de este dispositivo a médicos // Nota: La legge federale (USA) limita l'uso
di questo dispositivo a medic // ) // Opmerking: Volgens de federale wet in de VS mag dit product uitsluitend door
een arts worden gebruikt. // Aviso: Conforme a legislação federal dos EUA, a utilização deste produto está apenas au-
torizada a médicos // Varning: Federal lag (USA) tillåter endast användning av denna produkt för läkare // Προσοχή:
Σύμφωνα με την ομοσπονδιακή νομοθεσία των ΗΠΑ η χρήση αυτού του προιόντος είναι επιτρεπτή μόνο από έναν ιατρό
// Upozornění: Podle národní legislativy USA je dovoleno používat tento produkt pouze lékaři // Tájékoztató: Az Ame-
rikai Egyesült Államok szövetségi törvénye alapján a termék alkalmazása csak orvos által engedélyezett // Указание:
Согласно федеральному законодательству США, данным продуктом может пользоваться только врач // Infor-
macja: Zgodnie z prawem federalnym Stanów Zjendoczonych do stosowania niniejszego produktu uprawnieni są
wyłącznie lekarze. // ‫.تحذير: يحظر القانون الفيدرالي (بالواليات المتحدة األمريكية) بيع هذا الجهاز إال من خالل الطبيب أو بنا ء ً على طلبه‬
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Instructions for Use
Multi-Snare®, Multi-Snare® Micro, Multi-Snare® VSD Loop-Set

Product description

The Multi-Snare® and the Multi-Snare® Micro are both considered as medical devices. They merely differ because of their dimensions. They
are made out of a super elastic Nitinol wire, wrapped with a thin, radiopaque Platinum wire around the distal pre-formed loop. A PTFE tube is
shrunk on the proximal shaft of this loop to ensure good torqueability. The super elastic characteristics and the shape memory effect of the
Nitinol material allow the snare to be inserted through the pfm medical snare catheter or through another catheter (check compatibility prior
use) to the region of interest without any risk of deformation. Depending on the position of the snare catheter's tip the diameter of the loop
is variable in a predetermined range (see label).
Both Multi-Snare®, and Multi-Snare® Micro are available as a set including the snare catheter. For better radiopacity a radiopaque marker is
located distally on the snare catheter shaft.
An insertion aid is provided to ease the guidance of the snare into the catheter. The provided torquer eases the handling of the product.
The Multi-Snare® Micro is available with diameters of 2 and 4 mm and in the length of 175 cm, whereas the standard Multi-Snare® is offered
from 5 to 30 mm in diameter and in the length of 125 cm.
The Multi-Snare® VSD Loop-Set contains a 15 mm snare as described above, but with an extended shaft. Also, the set features a 260 cm hydro-
philic-coated crossover wire (0.035 inch with 60° angled tip), and 2 metal clips. The Multi-Snare VSD Loop Set is only available without a sling
catheter. The Multi-Snare® VSD Loop-Set is not for use in the USA and Canada.
Please refer to the product label for exact dimensions, designs and compatibility with other devices.

General Information and Warnings

The product described here may be used only by specialist physicians who are familiar with the techniques used in diagnostic and interven-
tional cardiology.
These instructions for use and the information on the packaging should be read carefully before each use.
WA R N I N G S
Federal Law (USA) restricts this device to use by or on the order of a physician.
This product contains chemicals known to the State of California to cause cancer and birth defects or other repro-
ductive harm.
Do not use the product if the packaging has been opened, or is damaged, if you are not sure that it is sterile, or if the
expiry date has passed.
Each product is packed separately, and is delivered in an EO-sterilised and pyrogen-free condition. It is intended
for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization of medical devices
intended for single use only may result in degraded performance or a loss of functionality. Reuse of single use only
medical devices may result in exposure to viral, bacterial, fungal or prionic pathogens.
The product must be stored in a dry place. Do not expose the packaged products to direct sunlight.
Do not clip the Multi-Snare® VSD Loop-Set's clips directly onto the wire. Always protect the wire with compresses
against direct contact with the clips in order to avoid damaging the hydrophilic coating.
Indications
• I n general for the removal of foreign bodies out of the vascular system or a hollow organ, and for the manipulation of catheters, guide wires
etc. in the vascular system or in a hollow organ.
• B ecause of its dimensions (small diameter and long shaft) the Multi-Snare® Micro is especially suited for the removal of foreign bodies out of
distal smaller vessels.
• T he Multi-Snare® VSD Loop-Set is especially intended for supporting the contra-lateral positioning of a catheter using the crossover tech-
nique by aligning the guide wire. The shaft of the snare is extended especially for this indication in order to be able to push it forward over a
lying flow-directed balloon-tipped catheter. T he clips are suitable for fixing the wire in the crossover position.
Other examples of manipulation using a snare:
• Assistance at veni-puncture procedure in order to provide central venous access.
• Fibrin sheath stripping of an indwelling venous catheter.
• Positioning resp. correction of position of an indwelling venous catheter.
19.04.2012_Rev04 19.04.2012_Rev04
English
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