Argon SKATER Instrucciones De Uso

en Instructions For Use
ar
cs Pokyny pro použití
da Brugsanvisning
de Gebrauchsanweisung
el Οδηγίες χρήσης
es Instrucciones de uso
et Kasutusjuhised
fi Käyttöohjeet
fr Mode d'emploi
hu Használati utasítás
it Istruzioni per l'uso
lt Naudojimo instrukcijos
nl Gebruiksaanwijzing
no Bruksanvisning
pl Instrukcja obsługi
pt-eu Instruções de utilização
pt-br Instruções de uso
ro Instrucţiuni de utilizare
sl Navodila za uporabo
sk Návod na použitie
sv Bruksanvisning
tr Kullanım talimatları
ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: 800-927-4669
Tel: +1 903-675-9321
www.argonmedical.com
Emergo Europe, Molenstraat 15, 2513 BH.
The Hague, The Netherlands
Tel: +31 (0)70 345 8570
Fax: +31 (0)70 346 7299
0086
IFU6500/0114
SKATER™ Introducer
en - English
‫تعليمات االستعمال‬
Device description
The SKATER™ Introducer System is intended for fine
needle puncture and tissue dilation with subsequent
positioning of a guidewire for catheter placement in non-
vascular procedures. The SKATER™ Introducer consists
of a 4F inner dilator with stiffening cannula that accepts
a 0.018" guidewire, and a 6F outer sheath that accepts
both 0.018" and 0.035" or 0.038" guidewires.
Indication for use
SKATER™ Introducer Systems with radiopaque marker
facilitate introduction and placement of a guidewire.
Contraindications
Physician judgement should be used in determining for
which patients percutaneous interventional procedures
are contraindicated.
Duration
Transient, less than 60 minutes.
Warnings
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Preparation of guidewire (if applicable)
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Procedure
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Storage
Store in a dark, dry, cool place. Avoid extended exposure
to light.
Disposal
After use, this product may be a potential biohazard.
Dispose in accordance with applicable laws and
regulations.
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Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
This device was designed, tested and manufactured
for single use only. Reuse or reprocessing has not
been evaluated and may lead to its failure and
subsequent patient illness, infection or other
injury. Do not reuse, reprocess or re-sterilize this
device.
Do not use if package appear open or if the expiry
date has been exceeded.
The product must only be used by qualified
personnel who are familiar with the technique.
Loosen the straightener together with the guidewire.
Flush the dispenser with saline.
Form the tip by running the spring tip over the edge
of the colored straightener.
Perform the skin incision under local anaesthesia.
Perform a fine needle puncture using ultrasound or
X-ray.
When the needle is correctly positioned, remove the
stylet and introduce the 0.018" guidewire.
Remove the needle and dilate with the assembled
coaxial introducer system.
Loosen the inner dilator, checking that the tip of the
outer sheath has been properly placed inside the
cavity (note the radiopaque ring marker).
Remove the stiffening cannula and inner dilator.
Introduce the 0.038" guidewire (not included).
Remove the outer sheath and withdraw the 0.018"
guidewire.
Insert and advance the required catheter (not
included) over the guidewire. Dilate further if
necessary.