Cook Medical G09469 - CATHETER, ANGIO, HNBR5.0-38-65-P-NS-KMP, 5/BX

Cook Medical G09469 - CATHETER, ANGIO, HNBR5.0-38-65-P-NS-KMP, 5/BX

Cook Beacon Tip 5.0 Fr Angiographic Catheter

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.

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

• Inspect the packaging and device to verify no damage. Do not use the product if the catheter or packaging is damaged.
• 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.
• Open the inner packaging using the standard operating room/ catheterization lab aseptic techniques to present the catheter to the operator.
• Flush the device prior to use.
• 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.
• When using a contrast power injector, ensure all connections are secure. Please refer to the Product Recommendations section for pressure and flow rate information.

Package Opening Steps

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.

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed practitioner).