Recommended Testing
Contents
1. cccccssscccessececesececeececeesceeseneceeeaecessuecessuaees 7 Test Requirements for PM4150 Portable Oxygen Concentrator cccceseccceseceeeeeeeeeees 11 Test Requirements for PM4130 Portable Oxygen Concentrator ccccceseceeeseeeceeeeeeeees 12 Test Requirements for PM4351 Stationary Oxygen Concentratol cccsccccsseceeeseeeeeees 13 Test Requirements for Medical Hose Assemblies cccccssecccsececseseeeneeeeeeeeeeceeeeeeeneens 14 Recommended Test EQUIDIMENE siivsesccavesstacsasaresscaavcdsancwevancwesnitacseadatayscasebsersodsateraratiawseanrens 15 Page 1 of 15 Test Requirements for the Easy Comp PM50 SS at ee See SY 10 11 12 13 14 Plug device into power source Switch power to ON Attach a calibrated pressure gauge to the outlet port Set pressure to 50 PSI Verify gauge accuracy is within 2 of full scale Set pressure to maximum valve assembly completely Clockwise Reading on gauge must be 2 85 PSI Power OFF device Remove pressure gauge Attach calibrated Flow gauge to valve assembly Power ON device Flow must be a 2 32 LPM Switch power to OFF and unplug Remove Flow gauge Test Requirements for the Easy Vac PM60 ene wee YS l l l l l O O ao A UO N e O Plug device into power source Remove suction canister assembly Attach a calibrated vacuum gauge to the device inlet port Switch power to ON Set vacuum to 15 InHg on calibrated vacuum2. 20 21 22 Connect regulator to a vacuum source capable of 21 InHg 100 LPM minimum Set the selector on the Vacuum Regulator to the REG position Turn the regulator knob clockwise then counterclockwise and ensure the gauge reaches full vacuum and also that it returns back to zero ensuring a smooth correlation between turning the knob and the corresponding needle movement Connect a calibrated vacuum gauge to the inlet port Set the regulator gauge to 60 mm Hg Ensure the calibrated vacuum gauge reading is within 5 of full scale Set the regulator gauge to 140 mm Hg Ensure the calibrated vacuum gauge reading is within 5 of full scale Set the regulator gauge to 200 mm Hg Ensure the calibrated vacuum gauge reading is within 5 of full scale 11 12 13 14 15 16 Disconnect the calibrated vacuum gauge Attach a calibrated flow gauge Turn knob on regulator fully clockwise Verify flow is gt 51 LPM Disconnect the calibrated flow gauge Set the regulator gauge to 180 mm Hg Switch to the INT position 18 19 Timing Module should engage between 6 to 10 seconds When the device clicks ON needle should return to 180 mm Hg and remain steady for 14 to 18 seconds Turn Regulator to the OFF position Disconnect regulator from vacuum source If any of the above checks do not meet specification troubleshoot the device and or adjust timing Page 9 of 15 Model PM3400 1
3. ee IS OF a ee SO 17 18 19 Connect regulator to a vacuum source capable of 21 InHg 100 LPM minimum Connect a calibrated vacuum gauge to the inlet port Set the selector on the vacuum regulator to the REG position Turn the regulator knob clockwise then counterclockwise and ensure the gauge reaches full vacuum and also that it returns back to zero ensuring a smooth correlation between turning the knob and the corresponding needle movement Set the regulator gauge to 60 mmHg 8 KPa Ensure the calibrated vacuum gauge reading is within 5 of full scale Set the regulator gauge to 140 mmHg 18 20 KPa Ensure the calibrated vacuum gauge reading is within 5 of full scale Turn the Vac device up to maximum fully clockwise verify max vac is 170 mmHg 10 Disconnect the calibrated vacuum gauge and connect a calibrated flow gauge 11 12 13 14 15 16 Verify flow is gt 50 LPM Disconnect the calibrated flow gauge Place the device in the REG position and set the needle to 120 mmHg Switch to the INT position Timing Module should engage between 6 to 10 seconds When the device clicks ON needle should return to 120 mmHg and remain steady for 14 to 18 seconds Turn Regulator to the OFF position Disconnect regulator from vacuum source If any of the above checks do not meet specification troubleshoot the device and or adjust timing Page 10 of 15 Test Requirements for PM4150 Portab
4. an inspiratory breath is taken with a cannula connected 10 Remove regulator from cylinder Page 5 of 15 Test Requirements for Flowmeters 1 Inspect product for visible damage Remove from service if any damage is found l 2 Turn control knob fully clockwise to the OFF position 3 Connect the device to the appropriate gas source The appropriate gas and pressure are specified on the Flow Tube 4 Verify that the Float Ball is at the very bottom of the Flow Tube NOTE If the Float is not resting at the bottom of the Flow Tube the device may be leaking consult the Troubleshooting Guide Connect a calibrated flow measuring device to the outlet of the flowmeter Ensure the flow measuring device is set to the correct gas type Oxygen or Air Divide the scale into three even divisions Low Middle and High om en Set the flow to the Low value by aligning center of Float Ball with indicator line on the Flowtube 9 Ensue the accuracy of the flowmeter is within the specifications stated in the user manual 10 Repeat step 8 amp 9 for the Middle amp High values Test Requirements for PM106 Oxygen Supply Manifold 1 Attach PM106 O2 Supply Manifold to a 50 psi 25 psi oxygen source 2 For each of the six valves perform the following test A Attach one end of tubing to the tubing nipple attach other end of tubing to a calibrated flowmeter B Turn Control Knob to 5 LPM setting and check the flow r
5. moving 6 Allow Device to run a minimum of 3 minutes 7 Attach hose from a calibrated oxygen flow monitor to outlet of flowmeter 8 Verify all flow settings are within the specified tolerance 9 Return the Flow Selector back to setting 5 10 Disconnect flow monitor from the Device outlet and connect a calibrated Oxygen Monitor Analyzer 11 Verify O2 concentration is within the specified tolerance 12 Disconnect the Oxygen Monitor Analyzer from the Device outlet 13 Unplug the Device from 120 VAC source while Power Switch is still in on I position 14 Verify a continuous audible alarm is heard 15 Turn The Device off by pressing Power Switch to off O position 16 The continuous audible alarm should stop Altitude Flow Tolerance l min Oxygen 200 ml settings 0 5 1 5 10 of settings 2 5 Bi se de Uptoesoot to 6 500 Uptoesoot 200 ml settings 0 5 GAs 6 501 10 000 ft 20 of settings 1 5 85 90 Page 13 of 15 Test Requirements for Medical Hose Assemblies Part 1 1 Part 2 Using approperate fitting s block off one end of Hose Assembly to be tested as illustrated Apply Oxy Tec or equivalent Leak Detector to each end of Hose Assembly and ensure that NO bubbles are evident 50 PSIG Air Using approperate fitting s connect opposite end of Hose Assembly to a 3 Way valve as illustrated Connect a pressure gauge capable of reading 50 PSIG to port of 3 Wa
6. test mode 3 Like a combination lock turn Selector Knob to 3 then 1 then 2 then off 4 Turn Selector Knob to any flow setting The device will continuously pulse 5 The alarm LED on the front will blink yellow and red while in test mode Steps 3 amp 4 must be completed within 8 seconds 6 Attach external power source to the POC if needed 7 In this mode you can go to any flow setting and test oxygen purity The EasyPulse POC will pulse as if it was attached to a simulator breathing 20 breaths per minute O gt Concentration should be 2 87 5 Ipm setting within 4 to 6 minutes 8 To return EasyPulse POC to normal operation turn Selector Knob to off position Once the device is turned to the off position you will need to go through the above steps above to get the device back into the test mode Page 12 of 15 Test Requirements for PM4351 Stationary Oxygen Concentrator Ensure Device Power Switch is in off position O Plug Device into a 120 VAC source Turn Dial Flowmeter on Device to Setting 5 a Aw YS FASYFLOWS 25 3 2 3 1s 4 1 5 5 oem 0 e Power on I Device 4 1 When powering on Device verify a momentary audible beep is heard and that the Green Yellow and Red LEDs on Front Panel illuminate for 1 second and then only the Green LED remains illuminated 5 Verify Fan is pulling air into the Device by placing your hand under the Base and verifying you feel air
7. FF position 18 Disconnect regulator from vacuum source Page 7 of 15 Model PM3100 1 2 3 10 11 12 13 14 Connect regulator to a vacuum source capable of 21 InHg 100 LPM minimum Set the selector on the vacuum regulator to the REG position Turn the regulator knob clockwise then counterclockwise and ensure the gauge reaches full vacuum and also that it returns back to zero ensuring a smooth correlation between turning the knob and the corresponding needle movement Connect a calibrated vacuum gauge to the inlet port Set the regulator gauge to 60 mmHg and ensure the calibrated vacuum gauge reading is within 5 of full scale Set the regulator gauge to 140 mmHg and ensure the calibrated vacuum gauge is within 5 of full scale Set the regulator gauge to 200 mmHg and ensure the calibrated vacuum gauge reading is within 5 of full scale Disconnect the calibrated vacuum gauge Attach a calibrated flow gauge Turn knob on regulator fully clockwise Verify flow is gt 51 LPM Set the selector on the vacuum regulator to the LINE position Verify flow is gt 55 LPM Turn regulator to the OFF position 19 15 16 17 Disconnect the calibrated flow gauge Turn knob on regulator fully counterclockwise Disconnect regulator from vacuum source lf any of the above checks do not meet specifications then troubleshoot the device Page 8 of 15 Model PM3300 1 oo oO or e 17
8. PRECISION MEDICAL 300 Held Drive Northampton Pa 18067 610 262 6090 June 10 2015 Table of Contents Test Requirements for the Easy Comp PM50 ssssssssssssssssssserrnssrrsssrrrsrrensreresrreserrssrrresreresns 2 Test Requirements for the Easy Vac PM60 cccccccssesecsecceeecsceeseseeeeceeeuecessuseeseeness 2 Test Requirements for the Power Vac PM61 ccccccssecccssecccesecsceeseseeeeeseeeueseteueeeeeensss 3 Test Requirements for the Power Vac Plus PM63 cccccseeccceeecsceesceceeneceeeeesetsueceseeness 3 Test Requirements for the Easy Go Vac PM65 cccccssecccsseceeesecsceesceeeeeeceeeneceseueceeeeaess 4 Test Requirements for the MinMate Easy Neb PM5 PM6 PM7 cccccccccseeeeeeeeeeeeeees 4 Test Requirements for the Easy Air PM15F cccccccccssececesecceenececeeseeeeeeceeeuesetsueeeseeness 4 Test Requirements for the Easy Air PM15P cccccccsseccceseccceecsceeseeseeeeceeeneceteueseeseness 5 Test Requirements for 1600 Series regulators ccccccsssececsececeeececeesceeeeseceeeaecessuecessenees 5 Test Requirements for Easy Pulse Conserving Regulators 188705 amp 198705 068 5 Test Requirements for Flowmeters cccceecccsscccescccenecceeceeececenceteueeteueeseeeceeeuseseneeteneetens 6 Test Requirements for PM106 Oxygen Supply Manifold ceccccssscceceseceeeneceseeseeeeenees 6 Test Requirements for Vacuum REBUlAtOSS
9. ate must be 5 1 LPM C Turn knob fully open and check the flow rate must be equal to or greater than 18 LPM Page 6 of 15 Test Requirements for Vacuum Regulators Models PM3000 PM3500 1 Connect regulator to a vacuum source capable of 21 InHg 100 LPM minimum Set selector on regulator to REG position Turn the regulator knob clockwise then counterclockwise and ensure the gauge reaches full vacuum and also that it returns back to zero ensuring a smooth correlation between turning the knob and the corresponding needle movement 4 Connect a calibrated vacuum gauge to the inlet port 5 Set the regulator gauge to 60 mmHg and ensure the calibrated vacuum gauge reading is 60 mmHg 4 6 Set the regulator gauge to 140 mmHg and ensure the calibrated vacuum gauge reading is 140 mmHg 4 7 For PM3000 only Set the regulator gauge to 200 mmHg and ensure the calibrated vacuum gauge reading is 200 mmHg 6 8 For PM3500 only Set the regulator knob fully clockwise and ensure the calibrated vacuum gauge reading is 170 mmHg 10 9 Disconnect the calibrated vacuum gauge 10 Attach a calibrated flow gauge 11 Turn knob on regulator fully clockwise 12 Verify flow is gt 51 LPM 13 Disconnect the calibrated flow gauge 14 Turn Knob on regulator fully counterclockwise 15 Ensure gauge returns to zero 16 If any of the above checks do not meet specifications troubleshoot device 17 Turn regulator O
10. device ON Turn white selector knob to REG position Set vacuum to 120 mmHG 4 7 InHg on calibrated vacuum gauge Verify device gauge accuracy is with 6 mmHG 24 InHg Set vacuum to maximum grey knob fully clockwise Measured vacuum shall be within 9 InHg 229 mmHG to 13 ES InHg 330 mmHG et Remove calibrated vacuum gauge Attach calibrated Flow gauge to inlet port Switch power to ON Flow must be 2 17 LPM Turn selector knob to INT let device run for 2 min Ensure needle cycles intermittently between 0 and full vacuum Turn grey knob counterclockwise until gauge reaches 100 mmHg Let device run for 2 min Ensure needle cycles intermittently between 0 and 100 mmHg Turn device off Remove calibrated Flow gauge Reattach suction canister assembly Page 3 of 15 Test Requirements for the Easy Go Vac PM65 Plug device into power source Remove suction canister assembly Attach a calibrated vacuum gauge to filter inlet port Switch power to ON Set vacuum to 15 InHg on calibrated vacuum gauge Verify device gauge accuracy is within 2 of full scale Set vacuum to maximum Completely Clockwise St MARA NN Reading on gauge must be 219 InHg Switch power to OFF 10 Remove vacuum gauge 11 Attach calibrated Flow gauge io filter inlet port 12 Switch power to ON 13 Flow must be 2 12 LPM 14 Switch power to OFF and unplug 15 Remove Flow gauge 16 Reattach suction caniste
11. gauge Verify device gauge accuracy is within 2 of full scale Set vacuum to maximum valve assembly completely Clockwise Reading on gauges must be 224 InHg Switch power to OFF Remove calibrated vacuum gauge Attach calibrated Flow gauge to valve assembly Switch power to ON Flow must be 2 29 LPM Switch power to OFF and unplug device Remove calibrated Flow gauge Reattach suction canister assembly Page 2 of 15 Pee a E asi comP re wifes Test Requirements for the Power Vac PM61 St MARA NN 9 10 11 12 13 14 15 16 Plug device into power source Remove suction canister assembly Attach a calibrated vacuum gauge to the device inlet port Switch power to ON Set vacuum to 15 InHg on calibrated vacuum gauge Verify device gauge accuracy is within 2 of full scale Set vacuum to maximum Reading on gauges must be 224 InHg Switch power to OFF Remove calibrated vacuum gauge Attach calibrated Flow gauge to device inlet port Switch power to ON Flow must be 2 22 LPM Switch power to OFF and unplug device Remove calibrated Flow gauge Reattach suction canister assembly Test Requirements for the Power Vac Plus PM63 a a ee eS YS 11 12 13 14 15 16 17 18 19 20 21 22 Switch power to OFF Plug device into power source Remove suction canister assembly Attach a calibrated vacuum gauge to the inlet port Turn
12. l has a reflective mirrored band with a micrometer adjustable knife edge pointer for easy to read accurate pressure readings www wika com Pressure Gauge Wika 4 Inspector s test gauges are the logical choice for precision pressure testing and convenient field calibrations High precision accuracy of 0 25 of span meets rigid ASME B40 1 Grade 3A quality standards The mirrored band on the dial and the knife edge pointer make it easy to take accurate pressure readings www wika com END Page 15 of 15
13. le Oxygen Concentrator Checking the Oxygen Purity Put the EasyPulse POC in Test Mode 1 Ensure the POC is not plugged in and an external battery is not connected p l Ensure the POC Selector Knob is in the off position for at least 15 seconds before attempting to put in to the test mode Like a combination lock turn Selector Knob to 5 then 1 then 3 then off Turn Selector Knob to any flow setting The device will continuously pulse The alarm LED on the front will blink yellow and red while in test mode Steps 3 amp 4 must be completed within 8 seconds Attach external power source to the POC if needed In this mode you can go to any flow setting and test oxygen purity The EasyPulse POC will pulse as if it was attached to a simulator breathing 20 breaths per ae minute O Concentration should be 2 87 5 Ipm lt s setting within 4 to 6 minutes i To return EasyPulse POC to normal operation turn Selector Knob to off position Once the device is turned to the off position you will need to go through the above steps above to get the device back into the test mode Page 11 of 15 Test Requirements for PM4130 Portable Oxygen Concentrator Checking the Oxygen Purity Put the EasyPulse POC in Test Mode 1 Ensure the POC is not plugged in and an external battery is not connected 2 Ensure the POC Selector Knob is in the off position for at least 15 seconds before attempting to put in to the
14. of full scale lf gauge does not reach 60 PSI Check the device for leaks Turn regulator knob back until you reach 50 PSI Se te ae Se iY S Remove pressure gauge from outlet fitting and attach a flow gauge capable of reading 40 LPM 10 Flow should be a minimum of 30 0 LPM 11 Remove flow gauge 12 Switch power to OFF Test Requirements for 1600 series regulators Attach regulator to a USP Oxygen cylinder with a minimum of 500 psi Ensure the regulator is in the off position Slowly open cylinder e Attached a calibrated flow gauge to the outlet port of the regulator Set regulator to first setting Measured flow should be within 10cc for settings 32 25cc to 125cc and 10 of the indicated setting of 250cc and up o P Se wW YS 7 Test all settings 8 Return the regulator to the off position 9 Close the cylinder and remove flow gauge 10 Remove regulator from cylinder Test Requirements for Easy Pulse Conserving Regulators 188705 amp 198705 Attach regulator to a USP Oxygen cylinder with a minimum of 500 psi Ensure the regulator is in the off position Slowly open cylinder Attached a calibrated flow gauge to the outlet port of the regulator Set regulator to the 2 LPM Continuous setting Measured flow should be 10 Remove the flow gauge from the outlet port of the regulator Return the regulator to the off position S p NS oe Ye YS To test the pulse settings ensure the device triggers when
15. r assembly 17 Also verify the charger for proper operation as indicated in the User Manual Test Requirements for the MinMate Easy Neb PM5 PM6 PM7 1 Plug device into power source 2 Switch power to ON 3 Attach a Westmed Inc Vixone Nebulizer Kit Part 0210 or equivalent to the output port 4 Attach a peace of tubing from the output of the Westmed Inc Vixone Nebulizer orifice to a Calibrated Flowmeter Gauge Measured output must be gt 6 LPM Do Remove Nebulizer from device 7 Switch power to OFF and unplug Test Requirements for the Easy Air PM15F Plug device into power source Turn regulator knob fully counterclockwise Attach a calibrated flow monitor to the outlet fitting on the PM15F Switch power to ON Turn regulator knob until flow monitor reads 5 LPM Verify reading on device flow gauge is within 1 LPM of flow monitor Turn regulator knob until flow monitor reads 10 LPM SS ee oe Verify reading on device flow gauge is within 1 LPM of flow monitor 9 Turn regulator knob fully counterclockwise 10 Switch power to OFF 11 Remove flow monitor Page 4 of 15 Test Requirements for the Easy Air PM15P Plug device into power source Turn regulator knob fully counterclockwise Attach a calibrated pressure gauge to the outlet fitting on the PM15P Switch power to ON Turn regulator knob until calibrated pressure gauge is at 60 PSI Verify device pressure gauge accuracy is within 2
16. y valve as illustrated Connect the remaining port of the 3 Way valve to a 50 PSIG Air presssue source as illustrated Turn on Air pressure source Open 3 Way valve to pressurize the hose assembly With the Hose Assembly still pressurized turn the 3 Way knob the opposite direction as illustrated Observe pressure gauge for 10 to 15 seconds The pressure should remain stable no loss a Ifthe pressure drops and or bubbles are detected the Hose Assembly fails the leak test Disconnect turn off Air pressure source Remove fitting s connecting the Hose Assembly to the 3 Way valve Remove fitting s blocking opposite end of Hose Assembly 50 PSIG Air Page 14 of 15 Recommended Test Equipment Flow Gauge Monitor The TSI Model 4040 Mass Flowmeter can be used for a multitude of gas flow measurement applications Whether measuring gas flows in a laboratory or manufacturing setting TSI general purpose mass flowmeters provide accurate results with multiple data output options The display versions come complete with accessories making setup and operation fast and convenient www tsi com Vacuum Gauge Wika 332 34 series industrial quality precision test gauges measure Vacuum within 0 25 of span Solid front blow out back rugged thermoplastic case meets safety requirements of ASME B40 100 Internal parts and process connection are made of 316 stainless steel providing excellent corrosion resistance The dia
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