Instructions for Use: Reprocessed Visions PV .035 Digital IVUS Catheter

Product Overview

The Reprocessed Visions PV .035 Digital IVUS Catheter is an over-the-wire intravascular imaging catheter designed for evaluating vascular morphology in peripheral blood vessels. It features a digital ultrasound transducer at the distal end that generates real-time cross-sectional images of vessels.

This catheter is intended for use with the Volcano Imaging System only and is introduced percutaneously or via surgical cutdown. It is designed to track over 0.035"-0.038" guide wires and has body markers for precise placement.

Indications and Contraindications

Indications for Use: The catheter is used for evaluating vascular morphology and providing cross-sectional images of peripheral blood vessels, serving as an adjunct to conventional angiographic procedures.

Contraindications for Use: The catheter is contraindicated for use in cerebral vasculature, situations with a high probability of tissue or organ damage, vessel spasm, severe calcification, angiographic evidence of thrombus, severe vessel tortuosity, or in patients unable to receive adequate anticoagulation.

Important Safety Information

Warnings: Use is restricted to specialists trained in the intended procedures. The catheter transducer is delicate and should not be misused. Do not use for purposes other than indicated.

Precautions: Read all instructions before use. Protect the catheter tip from impact and excessive force. Avoid cutting, creasing, or knotting the catheter. Protect electrical connections from fluid. Do not handle the transducer. Ensure proper guide wire usage and catheter advancement to prevent binding or entanglement, especially in stented vessels.

Adverse Reactions: Potential adverse effects include occlusion, vessel spasm, dissection, perforation, restenosis, hemorrhage, drug reactions, infection, and others, as with any catheterization procedure.

Product Specifications

Model: Visions PV .035
Outer Diameter: 7.0F (0.092", 2.33mm)
Scanner Diameter: 8.2F (0.108", 2.73mm)
Usable Length: 90 cm

Detailed acoustic output parameters are provided in the full document.

Sterilization and Warranty

This product is sterilized using ethylene oxide (EO) gas and is intended for single use only. Attempts to clean or sterilize the device by the user may result in bio-incompatibility, infection, or product failure.

Stryker warrants reprocessed products against defects in reprocessing and conformity to specifications for one use. Products manufactured by Stryker are warranted for one year from the date of purchase against defects in design, materials, and workmanship.

For more information on warranty terms and conditions, please refer to the complete document.

Contact Information

Reprocessed by: Northeast Scientific, Inc., 2142 Thomaston Ave., Waterbury, CT 06704

Distributed by: Stryker's Sustainability Solutions, 1810 W Drake Dr., Tempe AZ, 85283. Visit stryker.com or call 888 888 3433.

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