Precision Trading PM5200 User's Manual
Contents
1. Oxygen Concentration Dial Adial used for selecting oxygen concentrations between 21 100 The FiO scale is used for reference only This Dial does not rotate 360 The dial starts at 21 and ends at 100 Primary Outlet Port Amale DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device such as a flowmeter Auxiliary Outlet Port Amale 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 if the bleed is ON or OFF With the bleed in the ON position this outlet delivers accurate oxygen concentrations in the following flows Model Flow Range High Flow 2 100 Ipm Low Flow 0 30 Ipm Auxiliary Bleed Collar The collar is used to engage and disengage the bleed The bleed is necessary to maintain accurate FiO2 Concentration below 15 Ipm for the High Flow and 3 lpm for the Low Flow This collar is designed to prevent accidental disengagement of the bleed To activate the bleed turn the knurled collar until the bleed pin is engaged Slide collar back until it contacts the cover To deactivate the bleed pull collar away from cover while rotating until the collar slot engages the pin turn additional 1 4 turn to lock in place Oxygen Inlet Fitting A female DISS or NIST oxygen fitting with one way valve that is used to connect an oxygen supply2. OFF 2 Gas sources not connected 2 Turn gas sources ON Connect gas sources Alarm sounding 1 Difference between Oxygen and air inlet pressures greater than specified Correct pressure difference until Air and Oxygen pressures are within specification BLENDER AIR OXYGEN 13 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the 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 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
3. USER MANUAL AIR OXYGEN BLENDER DISS and NIST Connections Model No PM5200 Series PM5300 Series shown PRECISIO Vf Miz BLENDER Low Flow 0 5 30 We Oxygen LPM 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 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING PINSPEGTIONG icgestisecestesmransctanat ceusuitvehetaststinatendans 2 INTENDED SE tice We Weeer bt 2 READ ALL INSTRUCTIONS BEFORE UGIN 2 EXPLANATION OF ABBREVIATIONS AAA 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 SPECIFICATIONS isisisi enii eege gege EEeedAet Ee 5 DEE i cto st che ee EE 7 COMPONENT DESCRIPTION ii cccts cecacatcecscicansssdtaseacatgenavenncecvans 8 COMPONENT DESCRIPTION AA 9 ALARM TES Vistcsstncantteinnaneusaubads oveueGegudeadepusnasstadncnanatantottawsaies 10 REVERSE GAS FLOW PROCEDURE oeseri 10 OPERATING INSTRUCTIONS 10 PERFORMANCE GHEGK oicc sciccecensccenecs camecactscecpteneeesnereceonsans 11 CLEANING EE 11 MAINTENANCE vesiin eiaa iraani 12 TECHNICAL DESCRIPTION AAA 12 RETURNS ioina araa a a 12 DISPOSAL INSTRUCTIONS AAA 12 TROUBLE SHOO TIN Gases es sites Resta tas AE 13 LIMITED WARRANTY dest cist acentec nine a tirera Mania wow nentins 14 DECLARATION OF CONFORMI Y AA 15 BLENDER AIR OXYGEN 1 RECEIVING INSPECTION Remo
4. The Air Oxygen Blender is installed and the flowmeter is turned on Disconnect or turn off the air supply line to the Air Oxygen Blender 2 The Blender should alarm with a loud whistle noise The whistle indicates the alarm is operating correctly 3 Reconnect and activate the air supply line to the Blender the alarm should stop whistling 4 Disconnect or turn off the oxygen supply line to the Blender 5 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 REVERSE GAS FLOW PROCEDURE CE Requirements ONLY 1 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 air 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 bubbles indicate leakage Reference Air Oxygen Blender Service Manual P N 504827 4 Repeat steps 1 3 to check for leakage past the air inlet check valve OPERATING INSTRUCTIONS CAUTION Inspect the Air Oxygen Blender for visual damage before use DO NOT USE if damaged 1 Turn ON the Air and Oxygen supply 2 Adjust the Oxy
5. e Reverse Gas Flow Procedure e Operational Verification Procedure OVP CLEANING CAUTION e DO NOT steam autoclave e DO NOT immerse the Air Oxygen Blender into any liquid e DO NOT use any strong solvent or abrasive cleaners e DO NOT gas sterilize with ETO Ethylene Trioxide e DO NOT clean with aromatic hydrocarbons BLENDER AIR OXYGEN 11 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 Air Oxygen Blender must be performed by a trained service technician e Every month verify proper functioning of alarm e Every year conduct the Operational Verification Procedure OVP e Every 2 years the Air Oxygen Blender should be serviced PM5200 P N 505407 PM5300 P N 504932 e Refer tothe Air Oxygen Blender Service Manual P N 504827 for complete details regarding further maintenance and testing TECHNICAL DESCRIPTION For a complete Technical Description of the Air Oxygen Blender and list of Replacement Parts reference the Air Oxygen Blender Service Manual P N 504827 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 respo
6. gt 120 lpm gt 30 Ipm Flow All Outlets Bypass Flow Loss of Air or gt 85 lpm 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 When pressure differential is Alarm Sound Level 6 psi 0 4 bar or less gt to 80 db at 1 ft 0 3 m Oxygen Concentration Adjustment Range Gas Supply Pressure 21 100 30 75 psi 2 1 5 2 bar Air and Oxygen within 10 psi 0 67 bar of each other Mixed Gas Stability 1 Oxygen Connection Types BLENDER DISS Type Air amp Oxygen Inlets amp Outlets and or NIST Type Air amp Oxygen Inlets AIR OXYGEN 5 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 Ibs 1 3 kg Shipping Weight 3 5 Ibs 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 FiO2 Accuracy 3 of full scale 50 psi 3 4 bar 4 of full scale 60 psi 4 14 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 FiO High Flow l
7. hose BLENDER AIR OXYGEN 8 O COMPONENT DESCRIPTION ITEM DESCRIPTION F Air Inlet Fitting A male DISS or NIST air fitting with one way valve that is used to connect an air supply hose G Alarm An audible alarm that sounds due to an excessive pressure drop or deletion of either gas supply H Manifold Outlet Optional Manifold with 3 primary outlets l Rear Slide Mount with dove tail INSTALLATION AWARNING e Read this User Manual before installing or operating the Air Oxygen Blender e Confirm the concentration of air oxygen with an Oxygen Analyzer Monitor _ Secure the Air Oxygen Blender to a wall or pole bracket in an upright position 2 It is recommended to install a condensation trap in the air supply line 3 Connect the air and oxygen supply lines to the appropriate inlet fittings on the bottom of the Blender 4 Attach a flowmeter or other metering device to one of the outlet ports Primary Outlets Flow capacity e High Flow Blender PM 5200 Model 15 Ipm to 120 lpm e Low Flow Blender PM 5300 Model 3 lpm to 30 lpm Auxiliary Outlet This will bleed off some of the air oxygen mixture to maintain concentration accuracy at the Low Flow setting e High Flow Blender PM 5200 Model 15 Ipm or less e Low Flow Blender PM 5300 Model 3 lpm or less 5 Attach a supply line to the outlet port of the flowmeter BLENDER AIR OXYGEN 9 ALARM TEST 1
8. 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 less than 21 or over 100 oxygen will damage the Blender ACAUTION Turn off gas supplies when Air Oxygen Blender is not in use Store the Air Oxygen Blender in a clean dry area when not in use The Air Oxygen 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 Air Oxygen Blender into any liquid DO NOT gas sterilize with ETO Ethylene Trioxide 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 BLENDER AIR OXYGEN 4 CO SPECIFICATIONS Model PM5200 High Flow PM5300 Low Flow Primary Outlet 15 120 Ipm 3 30 lpm Flow Range With both supply pressures at 50 psi 3 4 bar with NO BLEED Auxiliary Outlet 2 100 Ipm 0 30 Ipm Flow Range With both supply pressures at 50 psi 3 4 bar with BLEED Bleed Flow 13 lpm or less 3 lpm or less at 50 psi 3 4 bar at 50 psi 3 4 bar Maximum Combined
9. THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED Precision Medical Inc shall not under any circumstances be liable for special incidental 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 BLENDER 14 AIR OXYGEN 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 Molenstraat 15 2513 BH The Hague The Netherlands Product Gas Mixers for Medical Use Model s PM5200EN PM5200MEN PM5300EN PM5300MEN MDD Class Ilb Classification criteria Clause 3 1 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 II 3 and the following documents Document Titl
10. e Edition ISO 14971 Medical Devices Application of Risk Management 2000 A1 2003 to Medical Devices EN 980 Graphical Symbols for Use in the Labeling of Medical 2003 Devices EN 1041 Information supplied by the Manufacturer with Medical 1998 Devices ISO 11195 Gas mixers for medical use stand alone gas mixers 1995 ISO 15001 Anesthetic and respiratory equipment Compatibility 2004 with oxygen Notified Body T V Rheinland Products Safety GmbH C 0197 EC Certificate No HD600119110 0001 www precisionmedical com ISO 13485 Certified CH _ oO X 504745 Rev8 E 03 18 08 M Printed in USA
11. gen Concentration Dial to the prescribed concentration NOTE The Oxygen Concentration Dial does not rotate 360 DO NOT force dial less than 21 or over 100 oxygen this will damage the Blender BLENDER 10 AIR OXYGEN 3 To activate the bleed turn the knurled collar until the bleed pin is engaged Then slide the collar back until it contacts the cover 4 Confirm the concentration of air oxygen with an Oxygen Analyzer Monitor 5 Confirm the flow of air and or oxygen mixture to the patient 6 Turn OFF the Air and Oxygen supply when deactivating the Auxiliary bleed and no device is attached to the outlet port 7 To deactivate the bleed pull the collar out away from the cover while rotating the collar until the slot engages the pin Then slide the collar past the pin and turn an additional 1 4 turn to lock in place NOTE This Procedure is completed with ease when all gas supplies to the Blender are turned OFF 8 Turn OFF the Air and Oxygen supply or disconnect when the Blender is not in use 9 Operational Verification listed below should be done before the Blender is placed in service Verification consists of e Alarm Test e Verify FiO2 Concentration with a Oxygen Analyzer Monitor e Reverse Gas Flow Procedure PERFORMANCE CHECK A detailed description of the tests listed below can be found in the Blender Service Manual P N 504827 available on the Internet www precisionmedical com
12. nsible 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 we BLENDER 12 AIR OXYGEN TROUBLESHOOTING If the Air Oxygen Blender fails to function consult the Troubleshooting Guide below If problem cannot be solved by using Troubleshooting Guide refer to the Air Oxygen Blender Service Manual P N 504827 available on the Internet www precisionmedical com or consult your Provider Problem Probable Cause Remedy Oxygen concentration discrepancy between Blender setting and Analyzer Monitor greater than 3 1 High Flow model flow requirement below 15 Ipm Low Flow model flow requirement below 3 Ipm 2 Analyzer Monitor inaccurate 3 Low flow bleed obstructed 4 Gas supply contaminated 5 Downstream device causing back flow or restricted flow 2 3 4 5 Use auxiliary outlet amp engage bleed Recalibrate Analyzer Monitor or Verify with second Analyzer Monitor Remove obstruction Check gas sources with calibrated Oxygen Analyzer Monitor to confirm Oxygen is 100 and Air is 21 Isolate Blender Check oxygen concentration at Blender Outlets No flow at Blender outlets 1 Gas sources turned
13. t 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 FiO The Air Oxygen Blender has been degreased for Oxygen Service prior to delivery The Air Oxygen Blender reverse gas flow complies with clause 6 of ISO 11195 The Oxygen Analyzer should comply with ISO 7767 to meet CE requirement Dryness and Composition for inlet gases Air Medical Air supply should meet the requirements of ANSI Z86 1 1973 commodity specification for Air type 1 grade D or better Oxygen Oxygen supply must meet all requirements of USP Medical Oxygen Grade N Dew Point Both inlets should remain 10 F 5 5 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 oxygen concentration will be affected if bleed is not activated at flow settings below 15 Ipm for the high flow Blender and 3 lpm for the low flow Blender Specifications are subject to change without prior notice BLENDER 6 AIR OXYGEN DIAGRAMS ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc Depending on model your fittings may differ from these diagrams PM5300 Model PM5200 Model BLENDER AIR OXYGEN 7 COMPONENT DESCRIPTION ITEM DESCRIPTION A
14. tially 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 AE CONSULT ACCOMPANYING DOCUMENTS Re Symbol for USE NO OIL Symbol indicates the device complies with the 0197 requirements of Directive 93 42 EEC concerning medical devices and all applicable International Standards On CE marked Devices ONLY AWARNING Only trained qualified medical personnel under the direct supervision of a licensed physician should operate the Air Oxygen Blender Use this Air Oxygen Blender only for its Intended Use as described in this manual Confirm prescribed dose before administering to patient Monitor on a frequent basis The Air Oxygen Blender shall be serviced by a qualified service technician Always follow ANSI and CGA standards for Medical Gas Products Flowmeters and Oxygen Handling BLENDER AIR OXYGEN 3 AWARNING An Oxygen Analyzer Monitor must be used to verify oxygen concentration Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 lpm for the High Flow Blender and 3 lpm 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
15. ve the Precision Medical Inc Air Oxygen Blender from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE Precision Medical Inc Air Oxygen Blender dispenses a continuous and precise blend of medical air and USP oxygen via outlet ports to infant pediatric and adult patients The exact Fractional Concentration of Inspired Oxygen FiOz blend of gases corresponds to the dialed in FiOz setting indicated by the control knob dial READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the Air Oxygen Blender This is provided for your safety and to prevent damage to the Air Oxygen Blender If you do not understand this manual DO NOT USE the Air Oxygen Blender and contact your Provider ADANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABBREVIATIONS FiO2 Fractional Concentration of Inspired Oxygen DISS Diameter Indexed Safety System NIST Non Interchangeable Screw Thread psi Pounds Per Square Inch lpm Liters Per Minute BLENDER AIR OXYGEN 2 O SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER Indicates an imminently hazardous situation which if not avoided will result in death or serious injury AWARNING ndicates a potentially hazardous situation which if not avoided could result in death or serious injury ACAUTION ndicates a poten
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