USER MANUAL - Pdfstream.manualsonline.com
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1. 98 Corrected Heliox Flow LPM at Various F102 Settings 128 104 96 94 92 02 0 152 144 126 17 108 106 104 92 90 14 0 2 75 0 16 0 17 0 18 0 19 0 200 21 0 220 230 240 250 260 27 0 280 29 0 300 31 0 N 320 330 340 350 360 eoo sez sre 41 444 437 426 377 370 39 HELIO2 BLENDER HELIUM OXYGEN 11 7 10 11 12 13 14 15 16 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 TECHNICAL DESCRIPTION For a complete Technical Description of the HELIO2 Blender and list of Replacement Parts reference the HELIO 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 Precision Medical Inc Return Policy available on the Internet www precisionmedical com DISPOSAL INSTRUCTIONS This device and its packaging contain no hazardous materials No special precautions need to be taken when disposing the device and or its packaging Please Recycle ics BLENDER 12 HELIUM OXYGEN TROUBLESHOOTING If the HELIO Blender fails to function consult the Troubleshooting Guide be2. 2008 1995 2007 2nd Ed 2004 2004 Notified Body T V Rheinland Products Safety GmbH C 0197 EC Certificate No HD60019110 0001 www precisionmedical com ISO 13485 Certified 505963 Rev3 E 04 05 10 PniNTED IN USA
3. collar away from the cover until bleed flow valve is closed 10 Turn OFF the heliox and oxygen supply or disconnect when the HELIO Blender is not in use CLEANING CAUTION DO NOT steam autoclave DO NOT immerse the HELIO Blender into any liquid DO NOT use any strong solvent or abrasive cleaners DO NOT gas sterilize with EtO Ethylene Oxide DO NOT clean with aromatic hydrocarbons 1 Disconnect all gas connections and equipment before cleaning 2 Clean exterior surfaces with a cloth dampened with mild detergent and water 3 Wipe dry with a clean cloth MAINTENANCE The following maintenance on the HELIO Blender must be performed by a trained service technician The alarm should be tested prior to being placed into clinical service and periodically there after Every year conduct the Operational Verification Procedure OVP A detailed description of the OVP tests can be found in the Blender Service Manual P N 506124 and available on the Internet www precisionmedical com Every 2 years the HELIO Blender should be serviced PM5400 P N 506125 PM5500 P N 506212 Referto the HELIO Blender Service Manual P N 506124 for complete details regarding further maintenance and testing ee BLENDER 10 HELIUM OXYGEN OXYGEN FLOWMETER CONVERSIONS Oxygen Flowmeter Setting zo 65 so s se 51 50 ea 75 72 7 59 5 60 ms 2
4. pressures are within specification BLENDER HELIUM OXYGEN 13 gt 2 5 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants thatthe HeliOzBlender 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 Medical Inc s instructions and standard industry practice and that no modifications substitutions or alterations have been made to the goods correct such defect by suitable repair or replacement at its own expense ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES The representatives of Precision Medical Inc or any retailers are not authorized to make oral warranties about the merchandise described in this contract and any such statements shall not be relied upon and are not part of the contract for sale Thus this writing is a final complete and exclusive statement of the terms of that contract THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY FITNESS FORAPARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED Precision Medical Inc shall not under any circumstances be liable for special incide
5. requirement Dryness and Composition for inlet gases Heliox Medical grade 80 20 or 70 30 is required Oxygen Oxygen supply must meet all requirements of USP Medical Oxygen Dew Point Both inlets should remain 10 F 12 2 C or more ONLY forCE below the lowest temperature to which the air requirements distribution system equipment is exposed At a temperature of 25 F 3 9 C and a pressure of 90 psi 6 33 kg cm this equates to 2000 mg m Accuracy of Fro will be affected if bleed flow is not engaged at low flows At or below Ipm for Low Flow and 15 Ipm for High Flow When Heliox tank pressure and oxygen outlet pressures are unbalanced bleed may need to be engaged at a higher liter flow to maintain accuracy Specifications are subject to change without prior notice HELIO2 BLENDER HELIUM OXYGEN 5 DIAGRAMS ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc PM5400 and PM5500 Models BLENDER 6 HELIUM OXYGEN COMPONENT DESCRIPTION ITEM DESCRIPTION A Oxygen Concentration Dial A dial used for selecting oxygen concentrations between 20 100 or 30 100 The Fro scale is used for reference only The actual Fro 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 B Pr
6. 80 5580 20 100 5470 5570 30 100 Gas Supply Pressure 30 75 psi 2 1 5 2 bar Heliox amp Oxygen within 10 psi 0 69 bar of each other Mixed Gas Stability Connection Types 1 Oxygen and or NIST Type Note All flow rate values are as measured from an Oxygen flowmeter uncorrected DISS Type Heliox amp Oxygen Inlets amp Outlets Heliox amp Oxygen Inlets BLENDER HELIUM OXYGEN SPECIFICATIONS continued Dimensions without fittings Depth 4 9 in 12 5 cm Width 2 3 in 5 7 cm Height 4 1 in 10 4 cm Weight 2 9 16 1 3 kg Shipping Weight 3 5 16 1 6 kg Operating Temperature Range 59 F to 104 F 15 C to 40 C Transport Storage Requirements Temperature Range 10 F to 140 F 23 C to 60 C Humidity Max 95 Noncondensing Accuracy 3 of full scale 50 psi 3 4 bar Pressure Drop Low Flow lt 2 psi 0 14 bar at inlet pressures from 30 90 psi 2 1 6 2 bar and at 10 Ipm flow rate at 60 Fro High Flow lt 3 psi 0 21 bar at inlet pressures from 30 90 psi 2 1 6 2 bar and at 30 Ipm flow rate at 60 Fro The Helium Oxygen Blender has been cleaned for Oxygen Service prior to delivery The Helium Oxygen Blender reverse gas flow complies with clause 6 of ISO 11195 The alarmed Oxygen Monitor Analyzer should comply with ISO 7767 to meet CE
7. Blender into any liquid DO NOT qas sterilize with EtO Ethylene Oxide DO NOT use if dirt or contaminants are present on or around the Blender or connecting devices DO NOT smoke in an area where oxygen is being administered DO NOT clean with aromatic hydrocarbons Inlet pressure of Device used in conjunction with the ELIO Blender must match inlet pressure of Blender HELIO2 BLENDER HELIUM OXYGEN 3 SPECIFICATIONS High Flow Low Flow Model PM5580 80 20 heliox PM5480 80 20 heliox PM5570 70 30 heliox PM5470 70 30 heliox Primary Outlet 15 120 3 30 Ipm Flow Range With both supply pressures at 50 psi 3 4 bar with BLEED Closed Auxiliary Outlet 2 100 0 30 Ipm Flow Range With both supply pressures at 50 psi 3 4 bar with BLEED Open Bleed Flow 13 Ipm or less or less 100 at 50 psi 3 4 bar at 50 psi 3 4 bar Maximum Combined gt 120 Ipm gt 30 Flow Outlets Bypass Flow Loss of Helium or gt 85 Ipm gt 45 Ipm Oxygen supply Bypass Alarm 50 psi 60 psi 50 psi 60 psi Activation 3 45 bar 4 14 bar 3 45 bar 4 14 bar 13 25 psi 16 24 psi 18 22 psi 16 24 psi 0 9 1 7 bar 1 1 1 65 bar 1 2 1 5 bar 1 1 1 65 bar Alarm Reset or less When pressure differential is 6 psi 0 4 bar Alarm Sound Level gt to 80 db at 1 ft 0 3 m Oxygen Concentration Adjustment Range PM54
8. EIVING INSPECTION Remove the Precision Medical Inc HELIO 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 acontinuous and precise blend of Medical Helium and Oxygen via outlet ports to infant pediatric and adult patients The exact F102 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen F102 setting indicated by the control face Oxygen concentrations can be dialed in from 2096 to 10096 for heliox tank mixtures of 2096 oxygen 80 helium and 3096 to 100 for heliox tank mixtures of 3096 oxygen 7096 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 1 READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the HELIO Blender This is provided for your safety and to prevent damage to the HELIO Blender If you do not understand this manual DO NOT USE the HELIO Blender and contact your Provider A DANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABB
9. NSTRUCTIONS CAUTION Inspect the HELIO Blender for visual damage before use DO NOT USE if damaged 1 Secure Blender to wall or pole mount bracket 2 Connect heliox and oxygen supply lines from HELIO Blender to heliox cylinder and oxygen supply 3 Connect oxygen flowmeter to Blender outlet 4 Adjust the Oxygen Concentration Dial to the prescribed concentration The balance of the concentration will be helium exiting the flowmeter NOTE The Oxygen Concentration Dial does not rotate 360 DO NOT force dial beyond the oxygen concentration endpoints as this will damage the Blender 5 Confirm the flow of heliox mixture to the patient 6 Actual heliox concentration to the patient may vary due to entrainment of room air via the patient interface device ACAUTION Refer to Oxygen Flowmeter Conversion Chart for corrected heliox flows An oxygen flowmeter should be used on the outlets of the Blender along with the corresponding flow conversion chart Actual flow from an oxygen flowmeter utilized to deliver heliox are higher than read on the flowmeter HELIO2 BLENDER HELIUM OXYGEN 9 7 Confirm the concentration of heliox with an Oxygen Monitor Analyzer If necessary activate the bleed flow valve to maintain 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
10. REVIATIONS FIHe O2 Fractional Concentration of Inspired Helium Oxygen Fro Fractional Concentration of Inspired Oxygen Heliox Helium Oxygen DISS Diameter Indexed Safety System NIST Non Interchangeable Screw Thread psi Pounds Per Square Inch Liters Per Minute SAFETY INFORMATION WARNINGS AND CAUTIONS Indicates an imminently hazardous situation which if not avoided will result in death or serious injury AWARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury ACAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury CAUTION Used without the safety alert symbol indicates a potentially hazardous situation which if not avoided may result in property damage CONSULT ACCOMPANYING DOCUMENTS Re 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 e 197 R Prescription Required ONLY HELIO2 BLENDER 2 HELIUM OXYGEN AWARNING Only trained qualified medical personnel under the direct supervision of a licensed physician should operate the HELIO Blender e Use this Blender only for its Intended Use as described in this manual Confirm prescribed dose before administering to patient Monitor on a fre
11. USER MANUAL HELIUM OXYGEN BLENDER DISS and NIST Connections Model No PM5400 Series shown PM5500 Series SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by or on the order of a physician PRECISION MEDICAL 300 Held Drive Tel 4001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING INSPECTION 1 INTENDED USE trie ee tee AAE 1 READ ALL INSTRUCTIONS BEFORE USING 1 EXPLANATION OF ABBREVIATIONS 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 SPECIFICATIONS 4 DI e 6 rna 7 ALARM TEST 3er teer ed ooa 8 REVERSE GAS FLOW 9 OPERATING INSTRUCTIONS eene 9 CLEANING Litus itta sand ented os AR fe OO N 10 MAINTENANCE sistit norte d MC a RR S 10 OXYGEN FLOWMETER 5 11 TECHNICAL DESGCRIPTION eap raa aont tnr lom nn ntn eret nn 12 RETURNS eis iode tior KU ra eea 12 DISPOSAL INSTRUGT IONS retient metn etn tennis 12 TROUBLESHOOTING 13 LIMITED WARRANTY ettet epu bertus vb ch o t vant 14 REC
12. d oxygen sources pressurize the Blender and turn ON the flowmeter 2 Set Oxygen Concentration Dial to 50 Froz 3 Disconnect or turn OFF the heliox supply line to the HELIO Blender The Blender should alarm with a loud whistle noise The whistle indicates the alarm is operating correctly 4 Reconnect and activate the heliox supply line to the Blender the alarm should stop whistling 5 Disconnect or turn OFF the oxygen supply line to the HELIO Blender The Blender should alarm with a loud whistle noise The whistle indicates the alarm is operating correctly 6 Reconnect and activate the oxygen supply line to the Blender the alarm should stop whistling 7 If alarm fails to function properly DO NOT USE BLENDER 8 HELIUM OXYGEN 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 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 leakage is 2100 ml min Reference HELIO Blender Service Manual P N 506124 4 Repeat steps 1 3 to check for leakage past the heliox inlet check valve OPERATING I
13. imary Outlet Port A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device such as a flowmeter Auxiliary Outlet Port A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device such as a flowmeter This outlet is equipped with a bleed valve that allows the user to control ifthe bleed is ON or OFF With the bleed in the position this outlet delivers accurate oxygen concentrations in the following flows Model Flow Range High Flow 2 100 Low Flow 0 30 D Auxiliary Bleed Collar The collar is used to engage and disengage the bleed The bleed is necessary to maintain accurate Fro Concentration below 15 lpm for the High Flow and lt Ipm for the Low Flow To activate the bleed slide and rotate the knurled collar back until it contacts the cover To deactivate the bleed pull and rotate collar away from cover until bleed flow valve is closed E Oxygen Inlet Fitting Afemale DISS or NIST oxygen fitting with one way valve that is used to connect an oxygen supply hose F Heliox Inlet Fitting A male DISS or NIST heliox fitting with one way valve that is used to connect a heliox supply hose G Alarm An audible alarm that sounds due to an excessive pressure drop or deletion of either gas supply H Rear Slide Mount with dove tail BLENDER HELIUM OXYGEN 7 PRE USE TESTING AWARNING e Read this User Manual before insta
14. lling or operating the Blender Confirm the concentration of heliox with an alarmed Oxygen Monitor Analyzer Confirm contents of heliox cylinder prior to use CAUTION Inspect the HELIO Blender for visual damage before use DO NOT USE if damaged NOTE The tests listed below should be performed prior to placing the HELIO Blender in service Pre Use Testing consists of Alarm Test Reverse Gas Flow Procedure 1 Secure the HELIO2 Blender to a wall or pole bracket an upright position 2 Connect the heliox and oxygen supply lines to the appropriate inlet fittings on the bottom of the HELIOz Blender 3 Attach a flowmeter or other metering device to one of the outlet ports and verify Frozrange for accuracy with an alarmed Oxygen Monitor Analyzer Primary Outlets Flow capacity High Flow Blender PM 5500 Model 15 to 120 Ipm Low Flow Blender PM 5400 Model Ipm to 30 lpm Auxiliary Outlet Use The auxiliary flow outlet maintains the same flow capacity and FIO2 accuracy as the Primary Outlets with Bleed Valve not engaged When the bleed flow is activated some of the heliox mixture will vent to atmosphere to maintain concentration accuracy at the low flow settings High Flow Blender PM 5500 Model 15 Ipm or less e Low Flow Blender PM 5400 Model 3 Ipm or less 4 Attach a supply line to the outlet port of the flowmeter ALARY TEST Connect the HELIO Blender to respective heliox an
15. low If problem cannot be solved by using Troubleshooting Guide refer to the HELIO Blender Service Manual P N 506124 available on the Internet www precisionmedical com or consult your Provider Probable Cause Oxygen concentration discrepancy between Blender setting and alarmed Oxygen Monitor Analyzer greater than 3 1 HIGH flow model flow requirement below 15 Ipm LOW flow model flow requirement below Ipm Alarmed Oxygen Monitor Analyzer inaccurate Low flow bleed obstructed Gas supply contaminated or heliox concentration incorrect Downstream device causing back flow or restricted flow Supply pressure imbalanced 1 Use auxiliary outlet amp engage bleed Recalibrate alarmed Oxygen Monitor Analyzer or Verify with second alarmed Oxygen Monitor Analyzer Remove obstruction Check gas sources with calibrated alarmed Oxygen Monitor Analyzer to confirm oxygen is 100 and verify heliox tank content Isolate Blender Check oxygen concentration at Blender Outlets Assure heliox and oxygen inlets pressures are within 10 psi No flow at Blender outlets Gas sources turned OFF Gas sources not connected Turn gas sources Connect gas sources Alarm sounding HELIO2 Difference between oxygen and heliox inlet pressures greater than specified Correct pressure difference until heliox and oxygen
16. ntal or consequential damages including but not limited to lost profits lost sales or injury to person or property Correction of non conformities as provided above shall constitute fulfillment of all liabilities of Precision Medical Inc whether based on contract negligence strict tort or otherwise Precision Medical Inc reserves the right to discontinue manufacture of any product or change product materials designs or specifications without notice Precision Medical Inc reserves the right to correct clerical or typographical errors without penalty SSS SSS SSSI SSIS SSL SSSR SSL SRL SSRIS SSS SS SS SSS LSS SS SESS BLENDER 14 HELIUM OXYGEN DECLARATION OF CONFORMITY Manufacturer Authorized European Representative Product Model s MDD Class Classification criteria Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Emergo Europe European Office Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Gas Mixers for Medical Use Blender PM5470EN PM5480EN PM5570EN PM5580EN IIb Clause 3 2 Rule 11 of Annex IX of MDD As delivered the object of the declaration described above is in conformity with the requirements of MDD 93 42 EEC Annex 11 3 and the following documents Document EN 980 EN 1041 ISO 11198 ISO 14971 ISO 15001 ISO 7000 Edition 2008
17. quent basis Continuous Monitoring with an alarmed Oxygen Monitor Analyzer is recommended The HELIO 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 used to verify oxygen concentration Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 Ipm for the High Flow Blender and 3 Ipm for the Low Flow Blender DO NOT obstruct the alarm DO NOT use Blender when alarm is sounding DO NOT use oil in or around the Blender DO NOT occlude or obstruct the bleed port on the auxiliary outlet of the Blender DO NOT use near any type of flame or flammable explosive substances vapors or atmosphere Oxygen Concentration Dial does not rotate 360 degrees Rotating the dial beyond the endpoint settings will damage the Blender ACAUTION Turn off gas supplies when Blender is not in use Store the HELIO Blender in a clean dry area when not in use The HELIO Blender contains magnetic ferrous material that may affect the results of an MRI Ensure all connections are tight and leak free Avoid excessive pressure surges greater than 100 psi 6 9 bar when pressuring the Blender inlets DO NOT steam autoclave DO NOT immerse HELIO
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