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ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 (903) 675 9321
Tel: +1 (800) 927 4669
www.argonmedical.com
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31 70 345 8570
Argon Medical Devices UK Ltd
Eastgate Business Centre
Eastern Avenue
Burton-on-Trent
Staffordshire
DE13 0AT
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en - English
SKATER™ Introducer
Intended Use/Purpose
The Skater
TM
Introducer System with radiopaque marker is intended for
fine needle puncture and tissue dilation with subsequent positioning of a
guidewire for catheter placement in non-vascular procedures.
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
•
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.
•
Inspect the package integrity before use.
•
Do not use if package appear open or if the expiry date has been
exceeded.
Do not continue to use if any of the component are damaged during
•
the procedure.
•
Introducer needle has a hub to help prevent fingers from
contacting/pulling wire. Do not pull Guidewire through needle.
Precautions
•
The product must only be used by qualified personnel who are
familiar with the technique.
Preparation of guidewire (if applicable)
•
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.
Procedure
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.
Storage
Store at controlled room temperature. Avoid extended exposure to light.
Disposal
After use, this product may be a potential biohazard. Dispose in
accordance with applicable laws and regulations.
NOTE: In the event a serious incident related to this device occurs, the
event should be reported to Argon Medical at
[email protected] as well as to the competent health
authority where the user/patient resides.
bg – Български
Игла за въвеждане SKATER™
Предназначение
Системата на иглата за въвеждане Skater
маркер е предвидена за тънко пробождане и разширяване на тъкани
с последващо разполагане на водач за поставяне на катетър при
неваскуларни процедури.
TM
с радиоотражателен