TORAYGUIDE^™

Guidewire

Indications

The TORAYGUIDE^™guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in coronary arteries.

Contraindications, Warnings and Cautions

A. Contraindications

The TORAYGUIDE^™guidewire is not intended for use in coronary arteries.

B. Warnings

• The tip of the guidewire is not designed to be reshaped.
• Do not introduce or remove the guidewire through a needle of any type. Damage to the distal coil may occur.
• Do not advance or remove any device over the guidewire if the circular coil is not fully extended and visualized. Never push, auger or withdraw a guidewire that meets resistance.

C. Cautions

• This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.
• When TORAYGUIDE^™ guidewire is used with any interventional devices, refer to the instructions supplied with them for the intended uses, contraindications, and potential complications.

Potential Complications

Potential complications associated with the use of the TORAYGUIDE^™ are vessel perforation, vessel spasm, hemorrhage, hematoma, vascular thrombosis, allergic reaction.

Disclaimer of Warranty and Limitation of Remedy

• Toray will replace defective product free of charge. In the event of a product complaint, the user is requested to return the TORAYGUIDE^™and packaging materials so that the cause of the complaint may be fully investigated.
• Toray is not responsible for any damage caused due to improper handling, operation, and storage, including use after the expiry date given on the product label.
• Toray is not responsible for any damage caused by transportation, handling, and storage at the health care facility, whether physical damage or human injury.