Philips PHOENIX Gebrauchsanweisung

Attention - Before using this device, Consult Instructions for Use
DEVICE NAMES
Phoenix Guidewire, Floppy Tip, Light Support
CAUTION: FEDERAL (US) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN.
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE, NOTING ALL WARNINGS AND PRECAUTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
INDICATIONS
The Phoenix Guidewire family is designed for percutaneous entry into the peripheral vascular system as an intravascular device by gently negotiating the vascular system while maintaining
enough strength and rigidity to enable a catheter to be directed over the guidewire with ease.
CONTRAINDICATIONS
This device is not intended for use in the coronary or neurovascular arteries.
DESCRIPTION
The Phoenix family is an 0.014 inch diameter X 300 cm length guidewires made of a Silicone coated Nitinol core wire that is tapered at the distal tip where a coil is secured to the distal end. The
distal coil is 5.5 cm and consist of Palladium. The tip and wire support of the guidewire are found on product labels and are summarized in Table 1.
Catalog No.
PG14300LF
WARNINGS
• The Phoenix Guidwire is supplied sterile and intended for one-time use only. Do NOT resterilize and/or reuse. Resterilization or reuse may potentially compromise device performance and
safety and may increase the risk of infection.
• Use the Phoenix Guidewire products prior to the "Use By" ("Expires") date speci ed on each individual package label.
• When the Phoenix Guidewire is exposed to the vascular system, it should not be advanced or retracted except under direct uoroscopic observation. If resistance is met during advancement or
retraction, determine the cause of the resistance before continuing.
• Do not withdraw guidewires through a metal trocar or metal needle.
• Do not advance or withdraw guidewires against resistance until the cause of the resistance has been determined. Excessive force against resistance may result in damage to guidewire and
catheter or vessel perforation.
• Volcano does not recommend a particular technique for the use of this device. The steps contained in the preceding directions discuss the Seldinger Technique of percutaneous entry are for
information purposes only. Each physician should evalute their appropriateness according to individual patient condition and his or her medical training and experience.
• Phoenix guidewires incorporate various performanc characteristics from tip shape to body sti ness. Extreme care must be taken in choosing the correct guidewire or to minimize the risk of
vessel perforation or vascular damage.
• Guidewires by nature of their construction will collect blood and other foreign matter in the coiled tip . No type of cleaning will completely remove this material. Therefore, they are intended for
single patient or one time use only. DO NOT RESTERILIZE.
• Do not use, or attempt to correct, a Phoenix Guidewire if it is bent or kinked or has any evidence of damage as this may result in breakage or compromised performance
CAUTIONS
• Prior to use, the Phoenix Guidewire should be inspected damage. If damaged, DO NOT USE.
• For use only by physicians trained in percutaneous peripheral interventional procedures.
• Carefully read all instructions pior to use. Observe all warnings and cautions. Failure to do so may result in complications
ADVERSE EFFECTS
Potential adverse e ects associated with the use of this device and other interventional catheters include but are not limited to the following (alphabetical order):
• Access site injury, including pain
• Arterial dissection
• Arterial perforation or pseudoaneurysm
• Arterial spasm or abrupt or sub-acute closure
• Death
• Embolism, including thrombus, plaque, air, device, etc.
The occurrence of these adverse e ects may lead to the need for repeat catheterization/angioplasty, emergency bypass surgery, or death.
PHOENIX GUIDEWIRE
INSTRUCTIONS FOR USE
Table 1: Phoenix Guidewire Models and Con gurations.
Tip and Wire Support Con gurations
Soft Tip /Light Support
• Fracture of any component of the device that may or may
not lead to serious injury or surgical intervention
• Hematoma requiring surgery
• Myocardial infarction
• Arrthythmia
• Renal Failure
Wire Tip Core Material
5.5 cm Nitinol
1
Diameter Length
0.36mm (0.014") 300 cm
• Myoglobinuria
• Reaction to contrast media, procedure medications or wire
materials, including allergic reaction
• Revascularization or vascular injury which may require
surgical repair or emergency surgery
PL3481.B 12/2018