COOK Medical Beacon Tip Catheters Інструкція з використання Посібник з використання - Сторінка 3

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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.

ENGLISH