INSTRUCTIONS FOR USE - Merit Medical

INTENDED USE OF PRODUCTA. INDICATIONSThe Fountain Infusion System with Squirt isintended to administer infusions of various therapeuticsolutions into the peripheral vasculatureof a patient.B. CONTRAINDICATIONSThe Fountain Infusion System with Squirt is contraindicatedfor use in the coronary vasculature.The Fountain Infusion System with Squirt is contraindicatedfor use during magnetic resonanceimaging.C. CAUTIONSDo not use the Fountain Infusion System with apower injector. Damage to the catheter or hemostasisvalve may occur.Do not infuse solution through the FountainInfusion System without the Merit Occluding Wirein place. Failure to use the Merit Occluding Wirewill result in the majority of therapeutic solutioninfusing only from the end of the catheter andnot through the side ports.Do not infuse into the Fountain Infusion Catheterwith any wire in place other than the MeritOccluding Wire. Using a standard guide wire oranother manufacturer's occluding wire couldresult in potential catheter damage and/orpatient injury.The Fountain Infusion System with Squirt shouldbe used only by physicians who have a thoroughunderstanding of infusion therapies and the associatedcomplications of those infusion therapies.Do not substitute or modify any components ofthe system with a component manufactured byany other manufacturer. Merit Medical cannotguarantee the proper function of another manufacturer’scomponents. Use only the Merit AccessPlus hemostasis valve with this Fountain InfusionCatheter.When introducing the Fountain Infusion Catheterthrough a synthetic graft, an introducer sheathshould be used. Damage to the infusion cathetermay occur if no introducer sheath is used.D. WARNINGA guide wire should never be advanced or withdrawnagainst resistance. If a guide wire isadvanced where there is resistance, it couldcause vessel trauma and/or wire damage. Thecause of the resistance should be determined utilizingfluoroscopy.All components must be adequately flushed withheparinized saline to displace air prior to insertioninto the body. Complications may occur if air hasnot been displaced. Correct placement of theguiding wire, catheter, and occluding wireshould be verified by fluoroscopy. Failure to usefluoroscopy could result in incorrect placementresulting in patient injury or death.Ensure that all connections are secure before use.Do not over tighten as excessive force may damagethe product.All therapeutic agents to be infused must be usedaccording to the manufacturer’s instructions for use.This device is intended for single use only.Federal (USA) law restricts this device to sale by oron the order of a physician.Store in a cool dry place.DESCRIPTION OF DEVICEThe Fountain Infusion System with Squirt consistsof the following components:One (1) Fountain Infusion Catheter with infusionholes at the distal section of the catheter.One (1) Occluding Wire which occludes the distalend of the Fountain Infusion Catheter.One (1) Access Plus hemostasis valveOne (1) 20 ml Medallion ® Reservoir syringeOne (1) Squirt Fluid Delivery SystemThe above components may be packaged in a singletray or may be packaged separately.E1