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U S E R M A N U A L
HELIO2
HELIUM-Oxyg En B LEnd Er
(DISS and NIST Connections)
Model No. PM5400 Series (shown)
PM5500 Series
SAVE THESE INSTRUCTIONS
Federal (USA) law restricts this device to sale
CAUTION
by or on the order of a physician.
300 Held Drive Tel: (+001) 610-262-6090
Northampton, PA 18067 USA Fax: (+001) 610-262-6080
www.precisionmedical.com
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CONTENTS RECEIVING / INSPECTION ................................................................1 INTENDED USE ..................................................................................1 READ ALL INSTRUCTIONS BEFORE USING ...................................1 Ex PLANATION OF ABBREVIATIONS ................................................2 SAFETY INFORMATION - WARNINGS AND CAUTIONS ..................2 SPECIFICATIONS .........................................................................
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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 Ins
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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 stan
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SPECIFICATIONS High Flow Low Flow Model PM5580: 80/20 heliox PM5480: 80/20 heliox PM5570: 70/30 heliox PM5470: 70/30 heliox 15 - 120 lpm 3 - 30 lpm Primary Outlet Flow Range With both supply pressures at 50 psi (3.4 bar) with BLEED Closed 2 - 100 lpm 0 - 30 lpm Auxiliary Outlet Flow Range With both supply pressures at 50 psi (3.4 bar) with BLEED Open 13 lpm or less 3 lpm or less Bleed Flow @ at 50 psi (3.4 bar) at 50 psi (3.4 bar) 100% FIO2 Maximum Combined ≥ 120 lpm ≥ 30 lpm Flow (All Outl
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SPECIFICATIONS continued dimensions: (without fittings) (12.5 cm) Depth: 4.9 in (5.7 cm) Width: 2.3 in Height: 4.1 in (10.4 cm) (1.3 kg) Weight: 2.9 lbs (1.6 kg) Shipping Weight: 3.5 lbs Operating Temperature Range: 59°F to 104°F (15°C to 40°C) Transport / Storage Requirements -10°F to 140°F (-23°C to 60°C) Temperature Range: Max 95% Noncondensing Humidity: ± 3% of full scale @ 50 psi (3.4 bar) FIO2 Accuracy:* Pressure drop: Low Flow: ≤ 2 psi (0.14 bar) at inlet pressures from 30-90 psi
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dIAGRAMS CAUTION Missing or illegible labels must be replaced, contact Precision Medical, Inc. PM5400 and PM5500 Models B A E F H G D C HELIO2 BLENDEr HELIUM-Oxyg En 6
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COMPONENT dESCRIPTION ITEM DESCRIPTION Oxygen Concentration dial A A dial used for selecting oxygen concentrations between 20% -100% or 30% -100%. The FIO2 scale is used for reference only. The actual FIO2 must be verified with an Alarmed Oxygen Monitor / Analyzer. This dial does not rotate 360°. The dial starts at 20% or 30% and ends at 100%. Primary Outlet Port B A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device, such as a flo
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PRE-USE TESTING WARNING • Read this User Manual before installing or operating the HELIO2 Blender. • Confirm the concentration of heliox with an alarmed Oxygen Monitor / Analyzer. • Confirm contents of heliox cylinder prior to use. CAUTION Inspect the HELIO2 Blender for visual damage before use, DO NOT USE if damaged. NOTE: The tests listed below should be performed prior to placing the HELIO2 Blender in service. Pre-Use Testing consists of: • Alarm Test • Reverse Gas Flow Procedure 1. Secure
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REVERSE GAS FLOW PROCEdURE (CE Requirements ONLY) 1. Assure bleed flow valve is not engaged. Disconnect the oxygen hose from the gas source. Remove all outlet connections from the HELIO2 Blender to ensure that there is no outlet flow. 2. Place the free end of the oxygen supply hose under water. While gradually increasing the heliox supply pressure from 30-75 psi (2.07-5.17 bar) check for leakage past the oxygen inlet check valve. 3. Replace the Duckbill Check Valve in the oxygen inlet, if le
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7. Confirm the concentration of heliox with an Oxygen Monitor / Analyzer. If necessary activate the bleed flow valve to maintain FIO2 accuracy. 8. To activate the bleed, turn and rotate the knurled collar back until it contacts the cover. 9. To deactivate the bleed, pull and rotate the collar away from the cover until bleed flow valve is closed. 10. Turn “OFF” the heliox and oxygen supply or disconnect when the HELIO2 Blender is not in use. CLEANING CAUTION • dO NOT steam autoclave. • dO
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OxYGEN FLOWMETER CONVERSIONS Oxygen Corrected Heliox Flow (LPM) at Various FIO2 Settings Flowmeter Setting 20% 30% 40% 50% 60% 70% 80% 90% 100% 1 1.8 1.6 1.4 1.3 1.2 1.18 1.15 1.02 1.0 2 3.6 3.2 2.8 2.6 2.4 2.4 2.3 2.0 2.0 3 5.4 4.8 4.2 3.9 3.6 3.5 3.5 3.1 3.0 4 7.2 6.4 5.6 5.2 4.8 4.7 4.6 4.1 4.0 5 9.0 8.0 7.0 6.5 6.0 5.9 5.8 5.1 5.0 6 10.8 9.6 8.4 7.8 7.2 7.1 6.9 6.1 6.0 7 12.6 11.2 9.8 9.1 8.4 8.3 8.1 7.1 7.0 8 14.4 12.8 11.2 10.4 9.6 9.4 9.2 8.2 8.0 9 16.2 14.4 12.6 11.7 10.8 10.6 10.4 9.2
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TECHNICAL dESCRIPTION For a complete Technical Description of the HELIO2 Blender and list of Replacement Parts, reference the HELIO2 Blender Service Manual (P/N 506124) available on the Internet; www.precisionmedical.com. RETURNS Returned products require a Returned Goods Authorization (RGA) number, contact Precision Medical, Inc. All returns must be packaged in sealed containers to prevent damage. Precision Medical, Inc. will not be responsible for goods damaged in transit. Refer to Pre
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TROUBLESHOOTING If the HELIO2 Blender fails to function, consult the Troubleshooting Guide below. If problem cannot be solved by using Troubleshooting Guide, refer to the HELIO2 Blender Service Manual (P/N 506124) available on the Internet; www.precisionmedical.com or consult your Provider. Problem Probable Cause Remedy 1. •HIg H flow model, 1. Use auxiliary outlet & Oxygen concentration flow requirement engage bleed discrepancy below 15 lpm. between Blender •LOW flow model, setting and fl
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LIMITEd WARRANTY ANd LIMITATION OF LIABILITY Precision Medical, Inc. warrants that the HeliO2 Blender, (the Product), will be free of defects in workmanship and/or material for the following period: Two (2) years from shipment Should any failure to conform to this warranty appear within the applicable period, Precision Medical, Inc. shall, upon written notification thereof and substantiation that the goods have been stored, installed, maintained and operated in accordance with Precision Med
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dECLARATION OF CONFORMITY Manufacturer: Precision Medical, Inc. 300 Held Drive, Northampton, PA 18067, USA CONTACT: Quality Manager Phone: 610-262-6090 Authorized European Representative: Emergo Europe (European Office) Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31 (0) 70.345.8570 Fax: +31 (0) 70.346.7299 Product: Gas Mixers for Medical Use (Blender) Model(s): PM5470EN, PM5480EN, PM5570EN, PM5580EN MDD Class: IIb Classification criteria: Clause 3.2 Rule 11 of Annex IX of MD
