COOK Medical Nester, Инструкция по эксплуатации

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ENGLISH
NESTER® EMBOLIZATION COILS
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
Nester Embolization Coils are made of platinum with spaced synthetic fibers,
and are supplied preloaded in a loading cartridge. They are designed to be
delivered to the target vessel using a soft, straight wire guide through a
standard angiographic catheter.
INTENDED USE
Nester Embolization Coils are intended for arterial and venous vessel
embolization procedures. The product is intended for use by physicians
trained and experienced in embolization techniques. Standard techniques for
placement of vascular access sheaths, angiographic catheters and wire guides
should be employed.
CONTRAINDICATIONS
None known.
WARNINGS
• Positioning of Embolization Coils should be done with particular care.
Coils should not be left too close to the inlets of arteries and should
be intermeshed with previously placed coils if possible. A minimal but
sufficient arterial blood flow should remain to hold the coils against the
previously placed coils until a solid clot ensures permanent fixation. The
purpose of these suggestions is to minimize the possibility of loose coils
becoming dislodged and obstructing a normal and essential arterial
channel.
• Nester Embolization Coils are not recommended for use with polyurethane
catheters or catheters with sideports. If a catheter with sideports is used,
the embolus may lodge in the sideport or pass inadvertently through it.
Use of a polyurethane catheter may also result in lodging of the embolus
within the catheter.
• If difficulties occur when deploying the embolization coil, withdraw the
wire guide, coil and angiographic catheter simultaneously as a unit.
PRECAUTIONS
• Perform an angiogram prior to embolization to determine correct catheter
position.
• Prior to introduction of the embolization coil, flush the angiographic
catheter with saline.
• If using a .018 inch MicroNester™ embolization coil, ensure that the
delivery catheter has an internal diameter (ID) between .018 and .025
inch.
PRODUCT RECOMMENDATIONS
Appropriately sized diameter TFE-coated wire guides with flexible tapered tips
are recommended for positioning Nester Embolization Coils. The following
table offers specific recommendations.
Coil Size Diameter Wire Guide Type & Size Catheter Type & Size
.018 inch TSF-18
STF-18
MF-2.5-18
MF-2.8-NT
MF-3.0-18 *
.035 inch TSFNB-35
TSFNA-35
TSFB-35
TSFBP-35
TSF-35
HNB(R)4.1-35
HNB(R)5.0-35
HNB6.0-35
SCBR5.0-35
.038 inch TSFNB-38
TSFNA-38
TSFB-38
TSF-38
HNB(R)5.0-38
HNB6.0-38
SCBR5.0-38
*
Available outside U.S.
INSTRUCTIONS FOR USE
1. Perform an angiogram prior to embolization to determine optimal
catheter position.
2. Firmly grasp the loading cartridge between thumb and forefinger.
Introduce the metal end of the loading cartridge into the base of the
catheter hub. Lock loading cartridge onto catheter hub by turning Luer
lock adapter clockwise. ( Fig. 1 )
Illustrations