INSTRUCTIONS FOR USE - Merit Medical

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T A B L E O F C O N T E N T SINTENDED USE OF PRODUCT .......................................... 1A. INDICATIONS .............................................. 1B. CONTRAINDICATIONS ......................................... 1C. CAUTIONS ............................................... 1D. WARNING ............................................... 1DESCRIPTION OF DEVICE ........................................... 1SYSTEM DIAGRAM ................................................ 2INSTRUCTIONS FOR USE ............................................ 3FLUSHING AND DEBUBBLING THE SYSTEM ............................... 3PRIMING THE SYSTEM WITH THERAPEUTIC SOLUTION ..................... 5ADMINISTERING INFUSION THERAPY ............................... 6INSTRUCTIONS FOR USE WITH A RESERVOIR BAG OR BOTTLE ................. 6I.V. PUMP INFUSION INSTRUCTIONS .............................. 6
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
Page 1: INSTRUCTIONS FOR USEINFUSION SYSTEM
Page 5 and 6: I N S T R U C T I O N S F O R U S E
Page 7 and 8: 9. The Squirt should be activated s
Page 9 and 10: MODE D’EMPLOISYSTÈME DE PERFUSIO
Page 11 and 12: UTILISATION DU DISPOSITIFA. INDICAT
Page 13 and 14: M O D ED’ E M P L O IVIDANGE ET P
Page 15 and 16: 9. Activer le système Squirt, de t
Page 17 and 18: ISTRUZIONI PER L’USOSISTEMA A INF
Page 19: FINALITÀ D'USO DEL PRODOTTOA. INDI
Page 22 and 23: 4. Attaccare lo Squirt alla valvola
Page 24 and 25: SOMMINISTRARE LA TERAPIA A INFUSION
Page 26 and 27: I N H A L T S V E R Z E I C H N I S
Page 28 and 29: ACCESS PLUSHÄMOSTASEVENTILG2
Page 30 and 31: 4. Den Squirt mit dem Hämostaseven
Page 32 and 33: INFUSION DES THROMBOLYTIKUMS12. Dur
Page 34 and 35: Í N D I C EUSO DEL PRODUCTO ......
Page 36 and 37: VÁLVULA DEHEMOSTASIAACCESS PLUSS2
Page 38 and 39: 4. Conecte el Squirt a la válvula
Page 40 and 41: ADMINISTRACIÓN DEL TRATAMIENTO POR
Page 42 and 43: Í N D I C EUTILIZAÇÃO PREVISTA D
Page 45 and 46: I NSTRUÇÕES DE U TILIZAÇÃOLAVAR
Page 47 and 48: 9. O Squirt deve ser activado, de m
Page 49 and 50: GEBRUIKSAANWIJZINGINSPUITINGSSYSTEE
Page 51 and 52: WAARVOOR HET PRODUCT BESTEMD ISA. I
Page 53 and 54:
G EBRUIKSAANWIJZINGHET SPOELEN EN H
Page 55 and 56:
9. Het Squirt moet geactiveerd word
Page 57 and 58:
B R U K S A N V I S N I N GI NFUSIO
Page 59 and 60:
AVSEDD ANVÄNDNING FÖR PRODUKTA. I
Page 61 and 62:
B R U K S A N V I S N I N GRENSPOLA
Page 63 and 64:
9. Squirt bör aktiveras så hepari
Page 65 and 66:
B R U G S A N V I S N I N GI NFUSIO
Page 67 and 68:
TILSIGTET ANVENDELSE AF PRODUKTA. I
Page 69 and 70:
B R U G S A N V I S N I N GSKYLNING
Page 71 and 72:
9. Squirt bør aktiveres, så hepar
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INSTRUCTIONS FOR USE - Merit Medical

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