ENGLISH
MICROCOILS™-18 COIL PUSHER
CAUTION: U.S. federal law restricts this device to
sale by or on the order of a physician (or a properly
licensed practitioner).
DEVICE DESCRIPTION
The Microcoils-18 Coil Pusher is a .018 inch diameter
PTFE coated stainless steel mandril shaft with a 49 cm
very soft distal spring coil tip, a 1 cm radiopaque
marker is placed 1 cm from the distal tip. (Fig 1)
The product also contains a wire guide inserter, and a
pin vise handle for manipulation.
Refer to label for further information.
INTENDED USE
The Microcoils-18 Coil Pusher is intended for
placement of .018 inch microcoils through a
microcatheter with an ID of .018 to .025 inches.
CONTRAINDICATIONS
None known.
WARNINGS
• Possible allergic reactions should be considered.
• Manipulation of products requires fluoroscopic
control.
• To determine correct catheter position, perform an
angiogram prior to embolization.
• Never advance the coil pusher outside the tip
of the microcatheter after the embolization coil
has been placed. This might displace the coil and
damage the vessel.
PRECAUTIONS
• The product is intended for use by physicians
trained and experienced in diagnostic and
interventional techniques.
• Standard techniques for placement of vascular
access sheaths, angiographic catheters and wire
guides should be employed.
• Prior to introduction of the coil, flush the
microcatheter with saline.
INSTRUCTIONS FOR USE
1. For coil loading instructions, please see IFU
supplied with the coil.
2. Introduce the coil pusher through the wire guide
inserter into the catheter.
3. Slowly advance the coil pusher under fluoroscopic
control until the coil has reached the target lesion
at the distal tip of the catheter. The coil must be
advanced completely outside the microcatheter.
4. To facilitate coil pusher control the radiopaque
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open
Illustrations
packages. The coil pusher may be used to deliver
multiple coils in one procedure. Sterile if package is
unopened or undamaged. Do not use the product
if there is doubt as to whether the product is sterile.
Store in a dark, dry, cool place. Avoid extended
exposure to light. Upon removal from package, inspect
the product to ensure no damage has occurred.
DISPOSAL OF DEVICE
This device is potentially contaminated with infectious
substances of human origin and should be disposed
of in accordance with institutional guidelines.
REFERENCES
These instructions for use are based on experience
from physicians and (or) their published literature.
Refer to your local Cook sales representative for
information on available literature.
ČESKY
PRUŽINOVÝ TLAČNÝ MANDRÉN
MICROCOILS™-18
POZOR: Federální zákony USA dovolují prodej
tohoto prostředku pouze prostřednictvím nebo na
předpis lékaře (nebo kvalifikovaného zdravotníka
s licencí).
POPIS PROSTŘEDKU
Pružinový tlačný mandrén Microcoils-18 je
mandrénový tubus z nerezové oceli, potažený PTFE,
o průměru 0,018 inch, se 49 cm dlouhým velmi
měkkým distálním pružinovým hrotem a 1 cm širokou
rentgenokontrastní značkou umístěnou 1 cm od
distálního hrotu. (Obr. 1)
Výrobek obsahuje také zavaděč vodicího drátu a
svěrací rukojeť pro manipulaci.
Další informace viz štítek výrobku.
URČENÉ POUŽITÍ
Pružinový tlačný mandrén Microcoils-18 je určen
k zavádění mikrospirálek o průměru 0,018 inch
mikrokatetrem o vnitřním průměru 0,018 až
0,025 inch.
KONTRAINDIKACE
Nejsou známy.
NOTE: Never advance the coil pusher outside the
microcatheter tip.
marker (1 cm from the tip) should remain inside
the microcatheter.
Илюстрации
3
