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, anglographic 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.
RODUCT RECOMMENDATIONS
• Maximum power injector machine settings should not exceed the labeled pressure.
• Labeled now rate achieved with I I.8cP contrast and contrast temperature of 22' C r 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.
