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Anleitung Zusammenfassung
300 Held Drive Tel: (+001) 610-262-6090 Northampton, PA 18067 USA Fax: (+001) 610-262-6080 CONTENTS RECEIVING / INSPECTION................................................................1 INTENDED USE..................................................................................1 READ ALL INSTRUCTIONS BEFORE USING ...................................1 ExPLANATION OF ABBREVIATIONS ................................................2 SAFETY INFORMATION - WARNINGS AND CAUTIONS..................2 SPECIFICATIONS ..............................................................................4 DIAGRAMS .........................................................................................6 COMPONENT DESCRIPTION............................................................7 ALARM TEST......................................................................................8 REVERSE GAS FLOW PROCEDURE ...............................................9 OPERATING INSTRUCTIONS............................................................9 CLEANING ........................................................................................10 MAINTENANCE ................................................................................10 OxYGEN FLOWMETER CONVERSIONS........................................ 11 TECHNICAL DESCRIPTION.............................................................12 RETURNS .........................................................................................12 DISPOSAL INSTRUCTIONS.............................................................12 TROUBLESHOOTING ......................................................................13 LIMITED WARRANTY.......................................................................14 RECEIVING / INSPECTION Remove the Precision Medical, Inc. HELIO2 (Helium-Oxygen) Blender from the packaging and inspect for damage. If there is any damage, DO NOT USE and contact your Provider. INTENdEd USE The Precision Medical, Inc. Helium and Oxygen Blender is designed to dispense a continuous and precise blend of Medical Helium and Oxygen via outlet ports to infant, pediatric and adult patients. The exact FIO2 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen (FIO2 ) setting indicated by the control face. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium. The Helium and Oxygen Blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery and monitoring of helium/oxygen mixture is required. The Blender is not intended as a life supporting device. HELIO2 BLENDEr HELIUM-OxygEn REAd ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the HELIO2 Blender. This is provided for your safety and to prevent damage to the HELIO2 Blender. If you do not understand this manual, DO NOT USE the HELIO2 Blender and contact your Provider. dANGER This product is not intended as a life-sustaining or life-supporting device. ExPLANATION OF ABBREVIATIONS FIHe-O2 Fractional Concentration of Inspired Helium-Oxygen FIO2 Fractional Concentration of Inspired Oxygen Heliox Helium-Oxygen DISS Diameter Indexed Safety System NIST Non-Interchangeable Screw Thread psi Pounds Per Square Inch lpm Liters Per Minute SAFETY INFORMATION - WARNINGS ANd CAUTIONS Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Used without the safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in property damage. CONSULT ACCOMPANYING DOCUMENTS dANGER WARNING CAUTION CAUTION Symbol for “USE NO OIL” Symbol indicates the device complies with the requirements of Directive 93/42/EEC concerning medical devices and all applicable International Standards. (On CE marked devices ONLY) Prescription Required HELIO2 BLENDEr 2 HELIUM-OxygEn WARNING • Only trained, qualified medical personnel under the direct supervision of a licensed physician should operate the HELIO2 Blender. • Use this HELIO2 Blender only for its Intended Use as described in this manual. • Confirm prescribed dose before administering to patient. Monitor on a frequent basis. Continuous Monitoring with an alarmed Oxygen Monitor / Analyzer is recommended. • The HELIO2 Blender shall be serviced by a qualified service technician. • Always follow ANSI and CGA standards for Medical Gas Products, Flowmeters and Oxygen Handling. • The clinician must verify the Heliox tank concentration prior to utilizing the Blender. • An alarmed Oxygen Monitor / Analyzer must be us...
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