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1. Wh ite Paper Biomedical Preventive maintenance on electrosurgical units how to increase your productivity If you have ever performed preventive maintenance PM on an electrosurgical unit ESU you know it requires significant background and proper information to do so In the past opting for manufacturers contracts may have alleviated these concerns When presented with a problem or failure you would call for a technician visit or loaner unit Your ESU was sent for maintenance and later returned repaired and or fully inspected for a flat rate cost ESUs were considered dangerous equipment and regardless of contract cost only the manufacturer would touch the device Yearly maintenance contracts were typically proposed by manufacturers Since that time the safety of ESU devices has increased dramatically During the same period increased budget restrictions have required careful scrutiny and or cancellation of expensive maintenance contracts Most hospitals have purchased newer safer ESU analyzers and initiated in house preventive maintenance for those devices You now send an ESU for repair only after confirmation of fault or defect How does this system work for you today Do you find preventive maintenance on ESU devices easy to perform How long does it take for you to perform preventive maintenance on an ESU Fluke Biomedical developed the Ansur automated version of the QA ES Electrosurgical Analyzer with simplification and p2. 180 W 250 Ohms 200 W 250 Ohms 220 W 250 Ohms 240 W 250 Ohms 260 W 250 Ohms 280 W 250 Ohms 300 W 250 Ohms Power Watts EEE Biomedical There are 128 load selections in the QA ES starting at 10 Q then from 25 Q to 2500 Q by 25 Q increments and from 2500 Q to 5200 Q by 100 Q increments Going so high may seem unnecessary but doing SO corresponds to some real life conditions For example when an organ is protected by a glucose solution the resistance becomes very high You can include any one of these loads in a power distribution test in increasing or decreasing order Output test Results Low Limit Power 0 20 0W 20 39 0W 40 58 0W 60 79 0W 80 97 0W 100 117 0W 120 137 0W 140 155 0W 160 175 0W 180 192 0W 200 212 0W 220 230 0W 240 247 0W 260 265 0W 280 289 0W LOW Output power adjustement 140 ESU Power Setting W High Limit 40 180 Current 284 0mA 396 0mA 482 0mA 560 0mA 622 0mA 682 0mA 738 0mA 785 0mA 35 0mA 874 0mA 917 0mA 956 0mA 991 0mA 1026 0mA 1072 0mA Vp p 225 0V 298 0V 364 0V 425 0V 470 0V 511 0V 560 0V 597 0V 635 0V 660 0V 693 0V 724 0V 750 0V 791 0V 16 0V 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com White Paper Measuring high frequency leakage current M lt Biomedical Measuring high frequency leakage current i
3. User defined J an ey Preventive procedures on To Tote Rena saa popular ESUs Test clement Status Value High im Low imit Unt Flags G Views Inspection Test passed W f d th d d EIZ Inpectng the Generator Accessones and intemal Components Test passed e per Or le e recol i len e Bipolar receptacles OK Pat Monopole seceptacies OK Pate 7 5 Pat Aaen ecto Pa manufacturer s Preventive Footevetch receptacles OK Patt Power cord OK 7 Past n piiri cmos 0K re Maintenance procedures on Ad vnus indicators and dipiays on the hont pane dumnate a n Activation tones sound to veely that the speaker is work ast acon ar ta as aaa aon nei Pot ogee hain po several popular ESUs both in the Sachore Dea Spa seting ol one wat e 8 he REM Abs nchcator Burrenates red ats Emoia re toe USA and Europe using the Ansur EZ Vertyrrg REM Function Test passed 1 Set the resistance substitution box to 120 ohms Connect the resintance box to the generator and confiem that the REM a t t d QA ES d bt d rcalo Bunait green l Y POT EIEEE Ape NPE EA Qik es RAI EREET N AA OEA Pats au O a e an O alne 3 Decrease the resistance to 60 ohma and venty that the REM indicatce Buminates geen Past tb 33 4 increase the resistance to 100 ohms and very that the REM alam sounds P PASS E D reports 5 Decrease the resistance to 30 ohms and verily that the REM indicatce Buminates geen Pats n 6 Decrease the resistance to 10 ohms and venty that the REM indicator Buminste geen P
4. 6 265 W 400 Ohms 245 268 0W 285 1 5 240 W 500 Ohms 220 226 0W 260 1 6 215 W 600 Ohms 195 196 0W 235 1 6 180 W 700 Ohms 160 168 0W 200 1 6 170 W 800 Ohms 150 155 0W 190 1 6 120 W 1000 Ohms 100 127 0W 140 1 6 110 W 1200 Ohms 90 108 0W 130 1 6 95 W 1400 Ohms 75 94 0W 115 1 6 80 W 1600 Ohms 60 84 0W 100 1 6 70 W 1800 Ohms 50 74 0W 90 1 6 60 W 2000 Ohms 40 67 0W 80 1 6 Power Watts Load Setting Ohms Power output vs setting Another requirement from ANSI AAMI IEC 60601 2 2 2006 is to show the power output versus the output control setting at a specified load usually the nominal value for which the power reaches its maximum Despite not being a usual requirement in the manufacturer s preventive maintenance protocols this is also easily achieved by the automated QA ES As this test requires an adjustment of the ESU power setting for each step it takes longer than a power distribution test but when using the QA ES internal footswitch to control the ESU this is still very convenient Current 1276 0mA 1164 0mA 960 0mA 21 0mA 673 0mA 572 0mA 490 0mA 444 0mA 359 0mA 302 0mA 260 0mA 227 0mA 201 0mA 182 0mA LOW Output power adjustement P 395 0V 713 0V 880 0V 977 0V 1022 0V 1063 0V 1065 0V 1102 0V 1135 0V 1165 0V 1149 0V 1206 0V 1172 0V 1218 0V Test Conditions Power Load 20 W 250 Ohms 40 W 250 Ohms 60 W 250 Ohms 80 W 250 Ohms 100 W 250 Ohms 120 W 250 Ohms 140 W 250 Ohms 160 W 250 Ohms
5. QA ES closes a relay when needed which generates the HF signal and automatically collects the result and stops the generator With one single click the measurement is performed collected and documented User friendly Ansur test automation secures your work Click on Next to go to the next step or on Start again if for example you forgot to set the proper mode on the ESU because the phone rang in the middle of your test The new measurement for this step will overwrite the previous erroneous one and this time the test will pass without having to restart the entire procedure from the beginning ees R Confirming Outputs Monopolar Output Cut 75W Pure Step 1 Check the Output for the Cut Modes 5 A Verify that the generator successfully completes the self test as described in Testing the Generator in this section B Connect the test equipment for monopolar output j 1 Connect one test cable to the left jack in the Monopolar 1 CEM Instrument receptacle d connect its other end to the QA ES Red input 2 Use a test cable to short the two pins on the Patient Retum Electrode receptacle 3 Connect the second test cable from the QA ES Black input to both pins of the Patient Retum Electrode receptacle 4 The 300 ohm resistor will automatically be selected 5 Connect the monopolar footswitch to the Monopolar 1 Footswitch receptacle on the rear panel of the generator OR use the QA ES intemal footsw
6. ansformer the RF signal is converted into a low voltage in order to be measured but this voltage is an image of the current not the HF output voltage generated by the ESU The QA ES measures the peak to peak voltage directly This is useful when troubleshooting an ESU Some ESUs require a voltage measurement at low frequency which cannot be accomplished with a current transformer Such coils have a low end frequency response at about 40 kHz The QA ES can handle this measurement 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com Wh ite Paper a Biomedical Summary The Ansur automated QA ES streamlines ESU preventive maintenance and allows you to gain productivity while increasing quality of work by 128 non inductive loads included in the unit Additional 200 Q load integrated in the unit for HF grounded ESUs Step by step test guide including picture diagram and hyperlink capabilities to minimize the human error risk Reproducible procedures including Checklists and user messages Output power current peak to peak voltage or crest factor measurements Power distribution curves are automatically drawn Output power vs setting curves are automatically drawn Optimized HF leakage currents sequence to minimize the wiring changes Low frequency leakage currents can be included when using an automation compatible electrical safety analyzer o Me
7. asurements are automatically captured and compared to the specified limits to eliminate human error All the above are included in one single electronic file and easily converted into a pdf document using on the shelf software The internal QA ES footswitch allows controlling the HF generation start and stop Automatically generates comprehensive reports including curves CMMS interface is available and automatable HF output peak to peak voltages are measured O O O O 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com
8. ates green 7 Decrease the resistance to 3 ohms and verify that the REM alarm sounds 8 Switch to a connector without the pin and increase the resistance from 3 to 24 ohms Verify Hhat Hha DEM alarm oru melo O Qr O Ol Km Mp sue 2 FRE oD 8 Power distribution curve You may sometimes need to perform a concentrated analysis of your ESU performance A surgeon may complain about perceived performance differences of a unit requiring you check if the manufacturer specifications are still fully met This may also be very helpful when evaluating a new device prior to purchase At these times you will want to draw a power distribution curve showing what power is effectively generated as expected over an extended patient load selection This data is required by standards ANSI AAMI IEC 60601 2 2 2006 for loads ranging from 100 Q to 2000 Q for all monopolar modes and Is provided in the manufacturer s service manual Once the test template is created Ansur test automation automatically captures a power distribution curve in approximately 20 seconds 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com LOW Power Distribution Curve Optional Test Conditions Results Power distribution test Power Load Low Limit Power High Limit CF 150 W 100 Ohms 130 166 0W 170 1 6 290 W 200 Ohms 270 277 0W 310 1 6 290 W 300 Ohms 270 280 0W 310 1
9. ats 7 Decsease the resistance to 3 ohms and verly that the REM aium sounds Pass B Switch to a connector without the pin and increase the resistance hom 3 to 24 ohms Verly that the REM alam sounds Pass D Contering Dup Test passed ES Bipoty Output Med Standard 10W Test passed noo 3330 21 0 mA GE Bipot Outpt Maceo 10W Tett passed 170 3330 291 0 mA GES Monropoty Output Cut 79W Pure Test passed 420 537 0 461 0 mA EE Monopol Outpt Cit TSW Low ca Test passed 451 0 537 0 461 0 mA Monopoly Outpt Cut TIW Blend Test passed 434 0 5370 4610 mA EE Moropas Outpt Fulgurate JOW Tert passed 2360 264 0 26 0 mA EES Monopol Output Spray SOW Test passed 2380 240 226 0 mA BRE Crheching High Frequency Leakage Curent Test passed FREES H F leakage test Monopolar Test passed Power 300 Losd 200 Mode Pure Act 1 730 100 0 mA Power 300 Losd 200 ModesLow Act 1 410 100 0 mA Powere200 Losd 200 Mode Blend Act 1 700 100 0 mA Power 300 Losd 200 Mode Pure Neu 1 630 100 0 mA Power 300 Losd 200 Mode Low Neu 1 330 1000 mA Powers 200 Losd 200 Modeslend Neu 1 670 1000 mA E SRH F akaga tast Bipolar modes Test passed Powere70 Losd 200 ModesPrecise Act 1 20 0 600 mA Power 70 Loade200 Mode Stand d Act 1 160 a0 mA Powere70 Losd 200 Mode Macto Act 1 340 a0 mA Power 70 Losd 200 Mode Precise Neu 40 60 mA Power 70 Loade200 ModesStandad Neu 1 190 60 mA Power 70 Loade200 ModesMacto Neu 1 430 600 mA Can you measure the output peak to peak voltage When using a current tr
10. g an ESU with HF grounded neutral plate you will need a second 200 Ohm load This additional load is integrated into the QA ES The diagrams are also available in the test guide The order to execute the measurements is optimized so the wiring changes are minimized again increasing your productivity 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com White Paper H F leakage test Monopolar modes Power 300W Electrode Active Electrode 1 Mode Pure 1 Adjust the ESU to the required specifications 2 Generate continuously the H F signal DO NOT use the QA ES foot switch input 3 Click Ok to continue or Cancel to stop the test Please make the wiring to measure the HF Leakage current from Active Electrode 1 to ground Measuring low frequency leakage current This is a major difference with other currently available devices If you are using one of the electrical safety analyzers listed below you can include an automatic electrical safety test in the protocol e ESA620 e ESA612 e ESA601 e QA 90 This allows you to utilize one single digital document per ESU including e Visual inspection REM ARM function test Performance analysis HF leakage current Low frequency leakage current EE Biomedical Clear instructions appear on the PC screen in large characters while performing the tests describi
11. it by inserting the bipolar footswitch or monopolar footswitch connector into the appropriate receptacle 2 Remove the fuse and verify correct voltage and current rating Refer to Section 3 Performance Characteristics If either connection is loose replace the footswitch board assembly Refer to Section 7 Footswitch Board Replacement Front Panel 1 Check the bipolar instrument receptacle for obstructions or damage Insert the MV Biomedical Checklists are easy to create and perform as shown in the opposite view Diagrams and pictures can be added Additional columns such as Not Applicable can also be included and can be useful when for example an accessory is missing The automation software automatically collects the test measurements and checks if they are within the specified limits bipolar instrument connector footswitching and handswitching into the nancnnenta ennnnbaala tn ssas n ananman Gb Bipolar receptacles OK Monopolar receptacles OK Patient Return receptacle OK Footswitch receptacles OK Power cord OK Internal components OK OO sic A na MY seo 2 eel v The limits can be set on power current voltage peak to peak or crest factor In this example the limits are set to current For power limits can be set either in of the nominal power or in absolute values watts If a QA ES internal footswitch is used the operator even doesn t have to press the ESU footswitch The
12. itch Power 75 Load 300 Mode 73 0 1 6 492 0 448 0 537 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com _ lt Biomedical Testing the REM ARM function When it comes to this important function we recommend using a decade box Ansur test automation can accurately describe and easily implement this test as shown below 8 Verifying REM Function wales Verifying REM Function REM plug and resistance substitution box 1 Set the resistance substitution box to 120 ohms Connect the resistance box to the generator and confirm that the REM indicator illuminates green 2 Slowly increase the resistance and verify that the REM alarm sounds at 135 5 ohms 3 Decrease the resistance to 60 ohms and venfv that the REM indicator illuminates green v OOOOOOO op 1 Set the resistance substitution box to 120 ohms Connect the resistance box to the generator and confirm that the REM indicator illuminates green 2 Slowly increase the resistance and verify that the REM alarm sounds at 135 5 ohms 3 Decrease the resistance to 60 ohms and verify that the REM indicator illuminates green 4 Increase the resistance to 100 ohms and verify that the REM alarm sounds 5 Decrease the resistance to 30 ohms and verify that the REM indicator illuminates green 6 Decrease the resistance to 10 ohms and verify that the REM indicator illumin
13. l Needed service manual information can be input into the Ansur template so bulky print manuals no longer need to be carried or stored nearby Each template can be named for the exact model it refers to Because Ansur templates are stored in a PC there is no limit to the number of PM procedures you can automate For teams that employ specialized technicians automated procedures can allow non specialized technicians with minimum training to successfully perform a PM with ease These new technicians are guided step by step while the software minimizes risk of human error by applying pre defined pass fail criteria 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com White Paper Fig 2 report example obtained with an Ansur automated QA ES 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com I Visual Inspection fou Inspecting the Generator Accessories and Internal Components M Equipment required Bipolar footswitch or monopolar footswitch Bipolar instrument cords handswitching and footswitching Monopolar instrument cords handswitching and footswitching Turn off the generator and disconnect the power cord from the wall receptacle Rear Panel 1 Check the rear panel footswitch receptacles for obstructions or damage Check for a secure f
14. ng which electrode what mode and what power to set up A similar screen appears when measuring a power distribution curve or a power output A performance printout can be viewed in the report shown on page 3 5 Visual Inspection Gq Verifying REM Function Sassy Confirming Outputs Saeed BS w Monopolar Output Spray 30 W gt Sa Optional curves Power Dist amp Output sy Low Frequency Leakage Currents Auto Sequence px Protective Earth Resistance Earth Leakage Current Enclosure Leakage Current Patient Leakage Current Mains on Applied Parts OZU Je ONOKIC sy4i Single Fault Condition Reversed Mains 5 Checking High Frequency Leakage Current IM General setup P gt Apply when Ai Expected results _timit___ _High_ Low Unit Op User defined Body ud Body Float ud Cardiac Float ud ud ud 2 IEC 60601 Body Float 5000 Cardiac Float 50 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com _ lt Biomedical The document can then be linked to your CMMS system a process that can also be automated with the Ansur automated QA ES The automated QA ES gathers equipment data from the CMMS to document device under test DUT information and selects the correct test protocol to be used after the test is performed it automatically creates a link between the results and the LJ equipment
15. roductivity in mind With this system all measurements are performed and documented within 12 to 15 minutes A customizable report shown in Fig 2 is automatically created at the end of the PM and can be exported in PDF format using any PDF creator software Step by step test guide There are several advantages for a biomedical department to adopt an automation solution Cumbersome PM procedures for devices with only periodic PM schedules are difficult to remember and necessitate a reliance on service manuals to remember step by step details related to the task Each model has a different procedure and sometimes one model has different procedures depending of its version This is a wasteful system Ansur test automation allows you to precisely define in a template every step to be performed Pictures and diagrams can be added to these templates to help you visualize how to do the job as shown in the example below 6045 Cochran Rd Cleveland OH 44139 USA Tel 440 248 9300 Fax 440 349 2307 Email sales flukebiomedical com www flukebiomedical com Confirming aint Confirming Outputs Use this procedure to ensure the accuracy of the generator Always confirm the output e After calibrating the generation e Every six months Equipment required e Two small test cables less than 61 cm 24 in long with banana plugs e QA ES e Bipolar footswitch and monopolar footswitch Mounting with the QA ES shown below Biomedica
16. s probably standard in your test procedure This is also conveniently performed with the Ansur automated QA ES The ability to upload diagrams and customized written instructions allow test visualization and minimized dependence on training resources The limits are freely set For monopolar outputs you would choose 100 mA if not using the special table described in the standard A lower limit is applicable for bipolar outputs usually 50 mA to 70 mA but the standard sets a formula based on the maximum power for a given bipolar mode It should not exceed 1 of the nominal power converted into current through the measurement resistor This formula is included in the QA ES Ansur automation software According to the standard the HF leakage currents are measured through a 200 Ohm load but Ansur allows the choice of any load when needed to reproduce a real life problem R Checking High Frequency Leakage Current woes HF Isolated Equipment Active Electrodes Active electrode test setup in compliance with IEC 601 2 2 sec 19 101b fig 104 and sec 19 102 Adopted by ANSII AAMI HF18 1993 Neutral Electrodes Neutral electrode test setup in compliance with IEC 601 2 2 sec 19 101b fig 104 and sec 19 102 Adopted by ANSII AAMI HF18 1993 Power 300 Load 200 Mode Pure 73 0 63 0 Power 300 Load 200 Mode Low 41 0 33 0 Power 200 Load 200 Mode Blend 70 0 67 0 a j uina M O stor wees MY sio g PASSED When testin
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