COOK Medical Approach CTO Gebrauchsanweisung Seite 3

APPROACH® CTO AND APPROACH® HYDRO ST
MICRO WIRE GUIDES
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
Approach CTO and Approach Hydro ST Micro Wire Guides are 0.014
inches (0.36mm) in diameter and are available in a variety of lengths and
configurations. Refer to product label for product specifications (wire guide
length, wire guide diameter, shaft configuration and tip length).
Approach CTO incorporates a stainless steel shaft along with distal stainless
steel and platinum coil tips of variable stiffness, used for general peripheral
vascular interventions.
Approach Hydro ST incorporates a stainless steel shaft with distal stainless
steel and platinum coils and a hydrophilic floppy tip, used for general
peripheral vascular interventions.
INTENDED USE
Approach CTO and Approach Hydro ST Wire Guides are intended for use in
facilitating delivery of percutaneous catheters into the peripheral vasculature.
CONTRAINDICTIONS
None known
WARNINGS
• This wire guide is a delicate instrument and should be handled carefully;
forceful angulation should be avoided.
• The wire guide should be advanced only when visualizing the tip of the
wire guide fluoroscopically. The wire guide should not be torqued without
evidence of corresponding movement of the distal tip.
• Refer to the labeling of the percutaneous catheter or other therapeutic
devices for contraindications and potential complications associated with use.
• Approach CTO series wire guides have stiff distal ends. Operate these wire
guides carefully to avoid injury to the blood vessel, observing information in
these instructions.
• Approach Hydro ST wire guides should never be used in conjunction with or
through a metal needle cannula.
PRECAUTIONS
• This 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.
• Avoid manipulating or withdrawing the wire guide back through a metal
needle or cannula. A sharp edge may scrape the coating or shear the wire
guide. A catheter, introducer sheath or vessel dilator should replace the
needle as soon as the wire guide has been inserted in the vessel.
• Excessive tightening of the torque device (if provided) onto the wire guide
may result in abrasion of the coating on the wire.
• Always flush the Hydro ST before use.
• Always maintain a wet surface on the hydrophilic portion of the Hydro ST for
optimal results.
INSTRUCTIONS FOR USE
1. Flush the wire guide holder by attaching or pressing a syringe with
heparinized saline or sterile water to the fitting of the wire guide holder
and injecting enough solution to wet the wire guide surface entirely.
2. Carefully remove the wire guide from the holder.
3. If desired, wire guide tip may be carefully shaped using standard tip
shaping techniques. Do not use a shaping instrument with a sharp edge.
4. Insert a wire guide insertion tool through the valve assembly of the
guiding sheath or guiding catheter.
5. Carefully insert the distal tip of the wire guide through the insertion tool.
6. Attach the torque device (if provided) to the wire guide.
7. Under fluoroscopy and while maintaining position of the peripheral
vascular access catheter, advance the wire guide to the targeted site.
NOTE: Under fluoroscopy, observe all wire guide movement in the vessels.
The wire guide should not be torqued without evidence of corresponding
movement of the distal tip. Further torquing against resistance may cause
vessel trauma or wire guide damage which may lead to device fracture. The
wire guide should be advanced only when visualizing the tip of the wire
guide fluoroscopically.
NOTE: If resistance is noted tactilely or visually under fluoroscopy,
determine the cause and take action necessary to relieve the resistance.
Advancement and withdrawal of the wire guide should be performed
slowly and carefully.
8. With the wire guide secured in place, advance the percutaneous catheter
or other therapeutic device to the target site.
NOTE: Always maintain a continuous flush while exchanging wire guides
to prevent air entry into the system.
NOTE: Prior to re-insertion of the exchanged wire guide, verify that the
distal tip of the cardiovascular device is free within the vessel. If the tip is
against the wall, vessel trauma may occur upon re-introduction of the wire
guide.
3
ENGLISH