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1. pressure difference until Air and Oxygen pressures are within specification BLENDER AIR OXYGEN 13 Precision Medical Inc 300 Held Drive Northampton PA 18067 USA BLENDER AIR OXYGEN 14 LIMITED WARRANTY AND LIMITATION OF LIABILITY Maxtec 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 Maxtec shall upon written notification thereof and substantiation that the goods have been stored installed maintained and operated in accordance with the product 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 Maxtec 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 THISWARRANTY IS EXCLUSIVEAND IS IN LIEU OFANY WARRANTY OF MERCHANTABILITY FITNESS FORA PARTICULAR PURP
2. OSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED Maxtec 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 liablities of Maxtec whether based on contract negligence strict tort or otherwise Maxtec reserves the right to discontinue manufacture of any product or change product materials designs or specifications without notice Maxtec reserves the right to correct clerical or typographical errors without penalty 507377 Rev1 06 26 12 Printeo in USA
3. SCRIPTION ITEM DESCRIPTION A Oxygen Concentration Dial Adial used for selecting oxygen concentrations between 21 100 The Flo 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 l min Low Flow O 30 l min Auxiliary Bleed Collar The collar is used to engage and disengage the bleed The bleed is necessary to maintain accurate F102 Concentration below 15 l min for the High Flow and lt 3 l min for the Low Flow To activate the bleed slide the knurled collar back until it contacts the cover To deactivate the bleed pull the 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 Amal
4. USER MANUAL AIR OXYGEN BLENDER DISS and NIST Connections Model No R203P14 R203P13 shown micromax O mare LOW FLOW 50 60 SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by or on Maxtec the order of a physician TEL 800 748 5355 6526 South Cottonwood Street FAX 801 270 5590 Salt Lake City Utah 84107 Email sales maxtecinc com USA EE Website www maxtecinc com QNET BV Hommerterweg 286 C 0123 6436 AM Amstenrade The Netherlands R203M13 Rev A CONTENTS RECEIVING INSPECTION coosisnaionein dde 2 INTENDED USE tipa 2 READ ALL INSTRUCTIONS BEFORE USING o 2 EXPLANATION OF ABBREVIATIONS sssocicicinnci aan 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 SPECIFICATIONS sciencon ieie ieaiaia 5 DIAGRAMS eae arpe aa cee a tees Ge eee 7 COMPONENT DESCRIPTION 8 PRE USE TESTING ui 9 ALARM TES Lis aa 10 REVERSE GAS FLOW PROCEDURE seeen 10 OPERATING INSTRUCTI N Sessions nal 11 CLEAN IN iscissnstaia coito 11 MAINTENANCE seinne 12 TECHNICAL DESCRIPTION surcicadia ad llar 12 RETURNS aia das 12 DISPOSAL INSTRUCTIONS 12 TROUBLESHOOTING corsa 13 BLENDER AIR OXYGEN 1 RECEIVING INSPECTION Remove the MicroMax Air Oxygen Blender from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE The MicroMax Air Oxygen Blender dispenses a
5. age 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 When using a bottled high pressure gas source always use a pressure reducing regulator set within 30 75 psi 2 1 5 2 bar BLENDER AIR OXYGEN 4 SPECIFICATIONS MicroMax High Flow MicroMax Low Flow Model R203P14 R203P13 Primary Outlet 15 120 l min 3 30 l min Flow Range With both supply pressures at 50 psi 3 4 bar with BLEED closed Auxiliary Outlet 2 100 l min 0 30 l min Flow Range With both supply pressures at 50 psi 3 4 bar with BLEED open Bleed Flow 13 l min or less 3 l min or less at 50 psi 3 4 bar at 50 psi 3 4 bar Maximum Combine
6. 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 F102 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 F102 Fractional Concentration of Inspired Oxygen DISS Diameter Indexed Safety System NIST Non Interchangeable Screw Thread psi Pounds Per Square Inch l min Liters Per Minute BLENDER AIR OXYGEN 2 SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION CAUTION AN XT 0123 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
7. d 2 120 l min 2 30 l min Flow All Outlets Bypass Flow Loss of Air or gt 85 I min gt 45 l min 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 to 80 db at 1 ft 0 3 m Oxygen Concentration 21 100 Adjustment Range 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 8 Oxygen Inlets Note All flow rate values are as measured from an Oxygen flowmeter uncorrected BLENDER AIR 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 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 Transport Storage Requirements Temperature Range 10 F to 140 F 23 C to 60 C Humidity Max 95 Noncondensing Frio 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 an
8. d at 10 l min flow rate at 60 Fioz High Flow lt 3 psi 0 21 bar at inlet pressures from 30 90 psi 2 1 6 2 bar and at 30 l min flow rate at 60 Flo 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 21647 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 55 C or more below the lowest temperature to which the air 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 l min for the high flow Blender and 3 l min 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 Maxtec Depending on model your fittings and or labels may differ from these diagrams R203P13 Model R203P14 Model BLENDER AIR OXYGEN fe COMPONENT DE
9. e 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 Rear Slide Mount with dove tail PRE USE TESTING 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 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 e Alarm Test e 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 F10 range for accuracy with an oxygen analyzer BLENDER AIR OXYGEN 9 Primary Outlets Flow capacity e High Flow Blender R203P14 Model 15 l min to 120 l min e Low Flow Blender R203P13 Model 3 l min to 30 l min Auxiliary Outlet The auxiliary flow outlet maintains the same flow capacity and Fio2 accuracy as the Primary Outlets with Bleed Valve not engaged When bleed flow i
10. eaning 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 e 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 R203M10 available on the Internet www maxtecinc com e Every 2 years the Air Oxygen Blender should be serviced e Refer to the Air Oxygen Blender Service Manual P N R203M10 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 R203M10 available on the Internet www maxtecinc com RETURNS Returned products require a Returned Material Authorization RMA number contact Maxtec All returns must be packaged in sealed containers to prevent damage Maxtec will not be responsible for goods damaged in transit Refer to Maxtec Return Policy available on the Internet www maxtecinc com Manuals available on our Website www maxtecinc com DISPOSAL INSTRUCTIONS This device and its packaging contain no hazardous materials No special precauti
11. ir Oxygen Blender Service Manual P N R203M10 Repeat steps 1 3 to check for leakage past the air inlet check valve BLENDER SSS JSS AR 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 F10 accuracy 7 To activate the bleed slide the knurled collar back until it contacts the cover 8 To deactivate the bleed pull the collar away from the cover until bleed flow valve is closed 9 Turn OFF gas supplies when Air Oxygen Blender is not in use CLEANING CAUTION e DO NOT steam autoclave DO NOT immerse the Air Oxygen Blender into any liquid DO NOT use any strong solvent or abrasive cleaners e DO NOT gas sterilize with EtO Ethylene Oxide e DO NOT clean with aromatic hydrocarbons 1 Disconnect all gas connections and equipment before cl
12. not avoided may result in property damage CONSULT ACCOMPANYING DOCUMENTS 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 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 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 l min for the High Flow Blender and 3 l min 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 dam
13. ons need to be taken when disposing the device and or its packaging Please Recycle amp 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 R203M10 available on the Internet www maxtecinc com or consult your Provider Problem Probable Cause Remedy Oxygen concentration discrepancy between Blender setting and Analyzer Monitor greater than 3 2 High Flow model flow requirement below 15 l min Low Flow model flow requirement below 3 min Analyzer Monitor inaccurate Low flow bleed obstructed Gas supply contaminated Downstream device causing back flow or restricted flow 1 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 Gas sources turned OFF Gas sources not connected _ Turn gas sources ON Connect gas sources Alarm sounding Difference between Oxygen and air inlet pressures greater than specified Correct
14. s activated some of the air oxygen mixture will vent to atmosphere to maintain F102 concentration accuracy at the Low Flow settings e High Flow Blender R203P14 Model 15 l min or less e Low Flow Blender R203P13 Model 3 l min or less 5 Attach a supply line to the outlet port of the flowmeter ls 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 Flo 3 Disconnector turn 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 f 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 A

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