Everest

Indications, Safety, and Warnings

Indications for Use

The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Warnings

For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness or death. Cleaning, disinfection and resterilization may compromise the essential material and design characteristics of the device leading to device failure.

These instruments are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform this procedure.

Always follow the manufacturer’s directions accompanying the balloon catheter for instructions for use, maximum inflation pressure, precautions, and warnings for use.

Improper tightening of the connection between the Inflation Device and Y/Tri-Adapter and accompanying equipment may result in introduction of air into the vascular system. Do not inject any fluid if air bubbles are visible within the fluid path of the Inflation Device or the Y/Tri-Adapter.

The pressure displayed on the inflation device must not exceed maximum recommended balloon catheter inflation pressure.

Prolonged exposure to contrast medium may cause components of the device to malfunction and thereby create a safety hazard.

Precautions

The components of the package have been delivered STERILE. Thoroughly inspect the components prior to use to verify that no damage has occurred during handling. If the package and/or its contents have been damaged, or contamination or damage is suspected for any reason, contact Medtronic (see address page). Do not resterilize.

CAUTION: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.