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ENGLISH
BEACON® TIP CATHETERS
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
Beacon Tip catheters are designed to facilitate diagnostic and therapeutic
procedures. Catheters are available in various configurations. Configurations
include different shaft lengths and tip curves and some catheters are
manufactured with a hydrophilic coating. Refer to the product label for
product specifications (e.g., catheter length, distal curve configuration).
INTENDED USE
Beacon Tip Catheters are intended for use in angiographic procedures by
physicians trained and experienced in angiographic techniques. Standard
techniques for placement of vascular access sheaths, angiographic catheters
and wire guides should be employed.
CONTRAINDICATIONS
None known
WARNINGS
The outer surface of the inner catheter package is NOT sterile.
PRECAUTIONS
• These products should be stored in their original sealed foil package with
required labeling.
• Manipulation of the catheter requires fluoroscopic control.
• If resistance is encountered during manipulation, stop and determine the
cause before proceeding any further.
• Do not attempt to heat or reshape the catheter curve; the catheter tip is
made from a heat-sensitive material.
• Activate hydrophilic coating, if present, by wetting the distal end of the
catheter with sterile water or saline. For best results, keep the catheter
surface wet during placement.
PRODUCT RECOMMENDATIONS
• Maximum power injector machine settings should not exceed the labeled
pressure.
• Labeled flow rate achieved with 11.8cP contrast and contrast temperature
of 22° C ± 2° C.
INSTRUCTIONS FOR USE
1. Inspect the packaging and device to verify no damage. Do not use the
product if the catheter or packaging is damaged.
2. Open foil packaging and remove or expose inner package containing the
sterile catheter. NOTE: The outer surface of the inner catheter package
is not sterile.
3. Open the inner packaging using the standard operating room/
catheterization lab aseptic techniques to present the catheter to the
operator.
4. Flush the device prior to use.
5. Under fluoroscopic guidance, advance the catheter over an appropriately
sized wire guide or through an appropriately sized sheath introducer
to the intended location. NOTE: If resistance is encountered during
manipulation, stop and determine the cause before proceeding any
further.
6. When using a contrast power injector, ensure all connections are secure.
Please refer to the Product Recommendations section for pressure and
flow rate information.
HOW SUPPLIED
This product is sterilized by ethylene oxide gas. Catheters are supplied in a foil
pouch and inner peel-open package. The outer surface of the inner package
is non-sterile. Store in a dark, dry, cool place. Use immediately once foil pouch
has been opened. Upon removal from package, inspect the product to ensure
no damage has occurred. Intended for one-time use.
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.
