USER MANUAL - Medical Dynamics, Inc.
Contents
1. 19 LIMITED WARRANTY eerte Ie reo Rea teet oe 14 DECLARATION OF 15 BLENDER AIR OXYGEN 1 RECEIVING INSPECTION Remove 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 F102 blend of gases corresponds to the dialed in 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 Fro 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 2 AIR OXYGEN SAFETY INFORMATION WARNINGS AND CAUTIONS Indicates imminently hazardous situation which if not avoided w2. Disconnect the oxygen hose from the gas source Remove all outlet connections from the Blender to ensure that there is no outlet flow 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 Replace the Duckbill Check Valve in the oxygen inlet if leakage is gt 100 ml min Reference Air Oxygen Blender Service Manual P N 504827 Repeat steps 1 3 to check for leakage past the air inlet check valve BLENDER AIR OXYGEN 10 OPERATING INSTRUCTIONS CAUTION Inspect the Air Oxygen Blender for visual damage before use DO NOT USE if damaged Secure Blender to wall or pole mount bracket 2 Connect Air and Oxygen supply lines from Blender to wall outlets 3 Connect flowmeter to Blender outlet 4 Adjust the Oxygen 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 5 Confirm the flow of air and or oxygen mixture to the patient 6 Confirm the concentration of air oxygen with an Oxygen Analyzer Monitor If necessary activate bleed flow valve to maintain accuracy 7 To activate the bleed turn and rotate the knurled collar back until it contacts the cover 8 To deactivate the bleed pull and rotate the collar away from the cover until bleed flow valve is closed 9 Turn OFF
3. Transport Storage Requirements Temperature Range 10 F to 140 F 23 C to 60 C Humidity Max 95 Noncondensing Fro Accuracy 3 of full scale 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 lpm 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 Air Oxygen Blender has been cleaned 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 12 2 C or more ONLY fr CE 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 for the low flow Blender Specifications are subject to change without prior notice BLE
4. gas supplies when Air Oxygen Blender is not in use CLEANING CAUTION DO NOT steam autoclave DO NOT immerse the Air Oxygen 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 BLENDER AIR OXYGEN 11 MAINTENANCE The following maintenance on the Air Oxygen 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 504827 available on the Internet www precisionmedical com Every 2 years the Air Oxygen Blender should be serviced PM5200 P N 505407 PM5300 P N 504932 Refer to the 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 produ
5. NDER 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 Oxygen Concentration Dial Adial used for selecting oxygen concentrations between 21 100 The Fro scale is used for reference only This Dial does not rotate 360 The dial starts at 21 and ends at 100 Primary 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 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 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 F102 Concentration below 15 Ipm for the High Flow and lt lpm 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 rotat
6. USER MANUAL BLENDER DISS and NIST Connections Model No PM5200 Series PM5300 Series shown Precisio Moy Low Flow 0 OW 0 3 Air Ony ee LPM SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by or on the order of a physician Precisiong Menon N Medical Dynamics 300 Held Drive TECHNOLOGY OF THE FUTURE TODAY Northampton PA 18067 USA Your local distributor 866 624 3952 www thinkMDl net www precisionmedical com CONTENTS RECEIVING INSPECTION 2 INTENDED USE 2 READ ALL INSTRUCTIONS BEFORE USING 2 EXPLANATION OF ABBREVIATIONS 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 SPECIFICATIONS ioter ti otto pd oi ett 5 Bien cm 7 COMPONENT 8 PRESUSE TES TING 9 ALARM TES T 35 o elita deste ides 10 REVERSE GAS FLOW PROCEDURE 10 OPERATING INSTRUCTIONS eee 11 ez wulcem 11 MAIN TENANG E en e ERE En 12 TECHNICAL 12 RETURNS ian ci cia tat eae eee 12 DISPOSAL INSTRUCTIONS iin 12 TFROUBLESHOOTING
7. alyzer Monitor to confirm Oxygen is 100 and Air is 21 Isolate Blender Check oxygen concentration at Blender Outlets No flow at Gas sources turned Turn gas sources Blender outlets OFF ON 2 Gas sources not 2 Connect gas connected 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
8. 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 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 OSS 5 SSSI SSIS SSL 5 sie SSL oae SSRIS SSS SS DSSS SSS SSS SES BLENDER 14 AIR 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 Netherland
9. cts 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 ws BLENDER AIR OXYGEN 12 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 Probable Cause High Flow model Problem Oxygen 1 Remedy 1 Use auxiliary outlet concentration discrepancy between Blender setting and flow requirement below 15 Ipm Low Flow model flow requirement contaminated Downstream device causing back flow or restricted flow 5 amp engage bleed Analyzer Monitor below 3 greater than 3 2 Analyzer Monitor 2 Recalibrate inaccurate Analyzer Monitor or Verify with second Analyzer Monitor 3 Low flow bleed 3 Remove obstruction obstructed 4 Gas supply 4 Check gas sources with calibrated Oxygen An
10. e collar away from cover until it reaches a positive stop Oxygen Inlet Fitting Afemale DISS or NIST oxygen fitting with one way valve that is used to connect an oxygen supply hose BLENDER AIR OXYGEN 8 COMPONENT DESCRIPTION continued ITEM DESCRIPTION F Air Inlet Fitting Amale 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 Rear Slide Mount with dove tail PRE USE TESTING AWARNING Read this User Manual before installing or operating the Air Oxygen Blender Confirm the concentration of air oxygen with an Oxygen Analyzer Monitor CAUTION Inspect the Air Oxygen Blender for visual damage before use DO NOT USE if damaged NOTE The tests listed below should be performed prior to placing the Blender in service Pre Use Testing consists of Alarm Test Reverse Gas Flow Procedure 1 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 and verify Fro range for accuracy with an oxy
11. gen analyzer BLENDER AIR OXYGEN 9 Primary Outlets Flow capacity e High Flow Blender PM 5200 Model 15 Ipm to 120 Ipm Low Flow Blender PM 5300 Model 3 Ipm to 30 Ipm Auxiliary Outlet The auxiliary flow outlet maintains the same flow capacity and Fro accuracy as the Primary Outlets with Bleed Valve not engaged When bleed flow is activated some of the air oxygen mixture will vent to atmosphere to maintain FIO concentration accuracy at the Low Flow settings High Flow Blender PM 5200 Model 15 Ipm or less Low Flow Blender PM 5300 Model or less 5 Attach a supply line to the outlet port of the flowmeter 22 TEST 2 Connect the Air Oxygen Blender to air and oxygen sources pressurize the Blender and turn ON the flowmeter Set Oxygen Concentration Dial to 60 Fro 3 Disconnectorturn OFF the air supply to the Air Oxygen Blender 4 5 6 7 The Blender should alarm with a loud whistle noise The whistle indicates the alarm is operating correctly Reconnect and activate the air supply line to the Blender the alarm should stop whistling Disconnect or turn OFF the oxygen supply line to the Blender The whistle indicates the alarm is operating correctly Reconnect and activate the oxygen supply line to the Blender the alarm should stop whistling If alarm fails to function properly DO NOT USE REVERSE GAS FLOW PROCEDURE CE Requirements ONLY 1
12. ill result in death or serious injury AWARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury ACAUTION ndicates 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 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 for the High Flow Ble
13. nder and 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 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 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 Blender must match inlet pressure of Blender BLENDER AIR OXYGEN 4 SPECIFICATIONS Model PM5200 High Flow PM5300 Low Flow Primary Outlet 15 120 lpm 3 30 lpm Flow Range Wi
14. s Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Gas Mixers for Medical Use Blender PM5200EN PM5200MEN PM5200NIST PM5300EN 5300 PM5300NIST 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 II 3 and the following documents EN 980 EN 1041 ISO 11198 ISO 14971 ISO 15001 ISO 7000 Notified Body T V Rheinland Products Safety GmbH C 0197 EC Certificate HD60019110 0001 www precisionmedical com ISO 13485 Certified c lt 504745 Rev12 E 05 18 10 M Printep IN USA
15. th both supply pressures at 50 psi 3 4 bar with BLEED closed Auxiliary Outlet 2 100 Ipm 0 30 lpm Flow Range With both supply pressures at 50 psi 3 4 bar with BLEED open Bleed Flow 13 lpm or less 3 Ipm or less at 50 psi 3 4 bar at 50 psi 3 4 bar Maximum Combined 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 6 psi 0 4 bar or less Alarm Sound Level gt 80 db at 1 ft 0 3 m Oxygen Concentration Adjustment Range 217 190 Gas Supply Pressure 30 75 psi 2 1 5 2 bar Air and Oxygen within 10 psi 0 69 bar of each other Mixed Gas Stability 1 Oxygen Connection Types DISS Type Air amp Oxygen Inlets amp Outlets and or NIST Type Air amp Oxygen Inlets Note All flow rate values are as measured from an Oxygen flowmeter uncorrected BLENDER AIR OXYGEN 5 SPECIFICATIONS continued Dimensions without fittings Depth 4 9 12 5 cm Width 2 3 in 5 7 cm Height 4 1 in 10 4 cm Weight 2 29 Ibs 1 04 kg Shipping Weight 2 95 Ibs 1 34 kg Operating Temperature Range 59 F to 104 F 15 C to 40 C
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