English - Philips PV018OTW Instrucciones De Uso

Instructions for Use
Reconnaissance PV Digital IVUS Catheter
Caution:
1. U.S. Federal Law restricts this device to sale by or on the order of a physician.
2. Prior to use, read this entire package insert.
Intended use:
The Reconnaissance PV .018 OTW Digital IVUS catheter is designed for use in the
evaluation of vascular morphology in blood vessels of the peripheral vasculature by
providing a cross-sectional image of such vessels. This device is not currently indicted
for use in cerebral vessels.
The Reconnaissance PV .018 OTW Digital IVUS catheter is designed for use as an adjunct
to conventional angiographic procedures to provide an image of the vessel lumen and
wall structures.
DESCRIPTION:
The Reconnaissance PV .018 OTW Digital IVUS catheter is an over-the-wire intravascular
imaging catheter with a digital ultrasound transducer at the distal end. The transducer
utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding
tissue and detects the subsequent echoes. The information from the echoes is used to
generate real-time images of the peripheral vessels.
The Reconnaissance PV .018 OTW Digital IVUS catheter is introduced percutaneously
or via surgical cutdown into the vascular system, and is designed to track over 0.014"-
0.018" (0.35-0.46 mm) guide wires.
A lubricious hydrophilic coating is applied externally to a distal portion of the catheter.
THE CATHETER IS FOR EXCLUSIVE USE WITH S5, CORE SERIES OF SYSTEMS AND
INTRASIGHT SYSTEMS. THIS CATHETER WILL NOT OPERATE IF CONNECTED TO ANY
OTHER IMAGING SYSTEM.
Contraindications:
Reconnaissance PV .018 OTW Digital IVUS catheter is generally contraindicated in
situations presenting a reasonable probability of tissue or organ damage. This device is
not currently indicated for use in cerebral vessels.
Adverse effects:
As with all catheterization procedures, complications may be encountered with the use
of the Reconnaissance .018 PV Digital IVUS catheter. Possible adverse effects include,
but are not limited to, the following: occlusion; vessel spasm; vessel dissection;
perforation, rupture or injury; restenosis; hemorrhage or hematoma; drug reactions;
allergic reaction to contrast medium; hypo/hypertension; infection; arteriovenous
fistula; embolism; entry puncture site bleeding; vascular wall injury; vessel thrombosis;
pseudoaneurysm (at site of catheter insertion); renal failure; aneurysm; vessel trauma
requiring surgical repair or intervention; death.
Reporting of a serious incident
If a serious incident has occurred in relation to the device, it should be reported to the
manufacturer and the competent authority of the Member State in which the user and/
or patient is established. A serious incident means any incident that directly or indirectly
led, might have led or, in case of recurrence, could lead to any of the following: the death
of a patient, user or other person, the temporary or permanent serious deterioration
of a patient's, user's, fetus or other person's state of health, or a serious public health
threat.
WARNINGS:
• Use of the Reconnaissance PV .018 OTW Digital IVUS catheter should be restricted to
specialists who are familiar with, and have been trained to perform, the procedures
for which this device is intended.
• The product is supplied sterile; if the pouch is opened or damaged compromising
the sterile barrier, please discard the product. This product cannot be re-sterilized
or re-used.
• The Reconnaissance PV .018 OTW Digital IVUS catheter is designed for single use
only. Philips, makes no warranty, representation or condition of any kind, whether
expressed or implied (including any warranty of merchantability, suitability or fitness
for a particular purpose) respecting the re-use of the catheter.
• In addition, Philips assumes no responsibility or liability for incidental or consequential
damages which may result from such re-use. Re-use including resterilization of
unused product may result in, but is not limited, to the following:
• Potential critical harm to patient due to Device Separation, Material Deformation
or Infection/Sepsis
• Failure to Image or other device malfunctions
• The catheter transducer is a delicate electronic assembly. Deliberate misuse by
bending, twisting or any other severe physical manipulation will void the warranty.
• Do not use the Reconnaissance PV .018 OTW Digital IVUS catheter for purposes other
than those indicated.
• Do not exceed maximum pressure rating of 300 psi.
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