Preventive maintenance on electrosurgical units
Contents
1. Figure 1 The QA ES Electrosurgery Analyzer hooked up to The Switch Box and an Electrosurgery unit If you ve ever performed preventive maintenance PM on an electrosurgical unit ESU you know it requires proper expertise and specialized informa tion to do so In the past opting for a manufacturer contract alleviated concerns surrounding ESU preventive maintenance When a problem or failure occurred users would call for technical repair and or request a loaner unit ESUs were sent for maintenance and later returned repaired and or fully inspected for a flat rate cost Because ESUs were considered dan gerous equipment only the manufacturer would touch the device regardless of contract cost In recent years ESU safety has substantially increased Most hospitals have newer safer ESU units and in house preventive maintenance programs Increased budget restrictions have required careful scrutiny and or cancellation of expensive maintenance contracts ESUs are now sent for repair only after a fault or defect has been confirmed Designed with these practices in mind Fluke Biomedical developed the Ansur automated version of the QA ES Electrosurgical Analyzer to wn Biomedical CLE help increase productivity safety and eliminate down time With this system all measurements are performed and documented within 12 to 15 minutes A customizable report is automatically created at the end of the PM and can be expor2. Electrosurgery units asses the presented imped ance to the active electrode and automatically adjust the output voltage or current This process improves coagulation However older genera tors may require manual ESU output adjustments during surgery The power distribution test applies the selected output energy through a series of test loads representing the variety of impedances pre sented in Figure 7 and displays the measured output energy The power distribution curve will show whether the energy selected is the energy delivered A power distribution curve also illustrates if the power output is effectively generated as expected over an extended patient load selection This data is required by standards ANSI AAMI IEC 60601 2 2 2006 in loads ranging from 100 Q to 2000 Q for all monopolar modes Once the test template is created the Ansur test automation automatically captures a power distribution curve in approxi mately 20 seconds There are 128 load selections in the QA ES starting at 10 Q then from 25 Q to 2500 Q increasing in 25 0 increments and 2500 Q to 5200 Q increasing in 100 Q increments Testing at such high impedance loads may seem unneces sary but doing so simulates real life conditions For example when an organ is protected by a glucose solution the resistance becomes very high Therefore testing at high impedance loads is not only necessary but critical Loads can be tested in increasing or decreasing orde
3. easily guides the user in verifying REM ARM alarm function Abort Abort the test template Previous Go to previous dialog screen Next Go to next dialog screen Start Perform test Stop Stop test Not applicable Flag test as not applicable Skip Skip test and go to next Additional Allows access to standards and customize toolbar menu features Figure 5 Toolbar buttons 1 Set the resistance substitution box to 120 ohms Connect the resistance box to the generator and confirm that the REM indicator illuminates preen 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 illuminates 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 that the REM alarm sounds Figure 6 Verifying REM function 3 Fluke Biomedical Preventive maintenance on electrosurgical units How to increase productivity using test automation software Power distribution curve Occasionally it s necessary to perform a con centrated analysis of ESU performance Newer
4. 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 thatthe REM indicator illuminates green 4 Increase the resistance to 100 ohms and verify that t the REM alarm sounds 7 5 Decrease the resistance to 30 ohms and verity that the REM indicator illuminates green 6 Decrease the resistance to 10 ohms and verity that the REM indicator illuminates green f Decrease the resistance to 3 ohms and verify thatthe REM alarm sounds 8 Switch toa connector without the pin and increase the resistance from 3 to 24 ohms Verify that the REM alarm sounds A C Y standart er aenned X Q next me tart na R skip STEP COMPLETED PASSED Figure 3 The Ansur test automation software shows clear pass or fail test outcomes 2 Fluke Biomedical Preventive maintenance on electrosurgical units How to increase productivity using test automation software Test results Biomedical High Le Power 75 Load 300 Mode M 750 500 0 Figure 4 Custom limits for power current voltage peak to peak and crest factor Additional columns such as Not Applicable can also be included to accommodate special circumstances such as a missing accessory The automation software automatically collects the test measurements and verifies they are within the specified limits Custom limits can be set for power current vol
5. 235 200 190 140 130 115 100 90 80 LOW Power Distribution Curve Optional Load Setting 0 hms Output test High Limit 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 LOW Output power adjustement 180 ESU Power Setting W Si e oe e e e e e e e e e a a a En On La On in in in inaia ina in ina ina in Fi ke e e e e e e e e e e a a a e in in in in in in in in in in in inia ina Current 1299 Ores 1201 Ore 991 Orn 842 Orr 675 0rd 577 Ord 492 0m 447 Omi 366 Or 305 0m4 265 Ord 232 Ord 205 0m 186 0m Current 283 Ord 401 Oru 499 Ore 573 Ord 634 Om 691 Om 759 Ore 808 0m 847 Ord 902 Ore 938 Ore 968 Ord 1019 0m 1054 0rA4 1085 0m Biomedical Vp p 385 0 70207 87707 981 07 983 0 1022 07 1017 07 1071 07 1110 07 1109 07 1140 07 1113 07 115407 1169 07 Vp p 2140V 286 0V 260 0 4400y 449 0Y 492 0 547 0 573 0 598 0V 643 04 6320 70407 74307 753 0V 77507 Measuring high frequency leakage current Measuring high frequency HF leakage current is a standard in most test procedures This can also be performed with the Ansur automated QA ES software The ability to upload diagrams and customized instructions allows test visualization and minimal dependence on training resources The limits are easily set to match the ESU specifi cations and testing procedure Figure 9 For monopolar outputs 100 mA is recommended
6. EM ARM function test Performance analysis HF leakage current Low frequency leakage current 5 Fluke Biomedical Biomedical Test 1 according to figure 102 Test setup in compliance with IEC 601 2 2 sec 19 101a test 1 fig 102 and sec 19 102 Adopted by ANSII AAMI HF18 1993 Test 2 according to figure 103 Test setup in compliance with IEC 601 2 2 sec 19 101a test 2 fig 103 and sec 19 102 Adopted by ANSII AAMI HF18 1993 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 Figure 9 High frequency leakage current After creation the document can be linked to the user s CMMS database system By beginning a work assignment created in the CMMS database the Ansur created ESU test template is automati cally launched The DUT information populates the appropriate fields in the template and the initial automated test guide is displayed with instruc tions for how to proceed After the test is performed the software auto matically creates a link between the results and the CMMS database The overall test status Pass Fail can be viewed on the CMMS database and used to automatically close the original work assignment assuming the o
7. mizes added to the Ansur template making bulky print risk of human error This occurs by automatically manuals an item of the past configuring the QA ES for the specific test and collecting pre defined values to determine pass or fail outcome Pass or fail outcomes are displayed in Figure 3 Active output Neutral Act Coag Cut Q bod R 47 Ohms Step 1 Check the Output for the Cut Modes 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 1 Connect one test cable to the left jack in the Monopolar 1 CEM Instrument receptacle Pass the test cable through the current transformer and connect the current transformer to the voltmeter 2 Use a test cable to short the two pins on the Patient Return Electrode receptacle 3 Connect the second test cable from the voltmeter to both pins of the Patient Return Electrode receptacle 4 Connect the 300 ohm resistor across the output jacks at the end of the test cables 5 Connect the itii footswitch to the a 1 Footswitch oe on the rear panel of the generator x Test resus SE High Limit Power 75 Load 300 Mode M 75 0 500 0 433 0 537 461 Figure 2 Step by step checklist for monopolar output test amp Test results 1 Set the resistance substitution box to 120 ohms Connect the resistance box to the generator and confirm that the REM indicator illuminates
8. ng pictures diagrams and hyperlinks e User friendly Ansur test automation functionalities including Checklists and user messages Output power current peak to peak voltage and crest factor measurements Low frequency leakage currents included when using an automation compatible with Fluke Biomedical electrical safety analyzers Measurements are automatically captured and compared to the specified limits to reduce human error Automatically generated comprehensive reports Biomedical About the QA ES Electrosurgery Analyzer The QA ES Electrosurgery Analyzer is the ESU tester you can depend on for complete preventive maintenance and ESU safety testing to test all Critical functions To learn more about the QA ES Electrosurgery unit Ansur test automation software or any other medical test equipment mentioned in this docu ment click here or visit flukebiomedical com Fluke Biomedical Better products More choices One company Fluke Biomedical 6045 Cochran Road Cleveland OH 44139 3303 U S A For more information contact us at 800 850 4608 or Fax 440 349 2307 Email sales flukebiomedical com Web access www flukebiomedical com 2013 Fluke Biomedical Specifications subject to change without notice Printed in U S A 11 2013 6001337A_EN Modification of this document is not permitted without written permission from Fluke Corporation 6 Fluke Biomedical Preventive maintenance
9. on electrosurgical units How to increase productivity using test automation software
10. otherwise use 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 However it should not exceed one percent of the nominal power converted into current through the measurement resistor load This formula is included in the QA ES Ansur auto mation software According to the standard HF leakage currents are measured using a 200 Q load When testing an ESU with HF grounded neutral plate a second 200 Q load is needed This additional load is integrated into the QA ES Measurement order is strategically optimized to reduce mid test wire changing resulting in increased productivity Instructions are shown in large characters on the PC during the tests to simply illustrate which electrode mode and power settings to use A similar screen appears when measuring a power distribution curve or a power output Measuring low frequency leakage current Protocols for testing low frequency LF current vary depending on the make and model of the ESU device The following electrical safety analyzers include an automatic electrical safety test in the protocol e Fluke Biomedical ESA615 e Fluke Biomedical ESA620 e Fluke Biomedical ESA612 Automatic electrical safety test protocol allows user to obtain one single model specific test result file and report per ESU including e Visual inspection R
11. r Power output vs setting The ANSI AAMI IEC 60601 2 2 2006 standard also requires the power output to be shown versus the output control setting at a specified load This is usually the nominal value for which the power reaches its maximum Figure 8 Power output testing is a requirement in the manufacturer s preventive maintenance protocols and can easily be achieved using QA ES test automation Because this test requires ESU power setting adjustments for each step it takes longer than a power distribution test However using the QA ES internal footswitch to control the ESU is still very convenient 4 Fluke Biomedical Preventive maintenance on electrosurgical units How to increase productivity using test automation software Power 150 W 290 W 290 W 265 W 240 W 215 W 180 W 170 W 120 W 110 W 95 W 80 W 70 W 60 W Power 20 W 40 W 60 W 80 W 100 W 120 W 140 W 160 W 130 W 200 W 220 W 240 W 260 W 280 W 300 W Load 100 Ohms 200 Oluns 300 Ohras 400 Ohms 500 Ohms 600 Oluns 700 Oluns 00 Oluns 1000 Ohms 1200 Ohms 1400 Ohms 1600 Ohms 1800 Ohms 2000 Ohms LOW Power Distribution Curve Optional Test Condinoms Results Low Limit 130 270 270 245 220 195 160 150 100 90 15 60 50 40 Figure 7 Power distribution curve OW Output power adjustement Test Condinons Figure 8 Power output graph Test type Power disfribufion fest Faigh Limit 170 310 310 285 260
12. tage peak to peak or crest factor In Figure 4 the limits are set for current For power limits can be set in percentage of the nominal power or in absolute values watts If the QA ES internal footswitch is used the operator does not need to press the ESU foot switch The QA ES closes a relay when needed which causes the high frequency HF signal to alarm and stops the generator while collecting results With one single click the measurement is performed collected and documented User friendly navigation Easy to use navigation allows users to verify proper settings and secure work Simply select NEXT to proceed to the next step Or select PREVI OUS to go back to verify the proper mode has been set on the ESU Figure 5 If a change is made the new measurement will overwrite the previous erroneous one and this time the test will pass without having to restart the entire procedure from the beginning Verifying REM Function REM plug and resistance substitution box Testing the REM ARM function A decade box is recommended to verify accurate REM ARM function The RECM test box Decade Resistance Box tests the Return Electrode Current Monitoring alarm Simply choose the cable that fits your ESU neutral plate connector and select the appropriate resistance value as instructed in the ESU manu facturer s RECM test procedure incorporated into the Ansur ESU test template As shown in Figure 6 Ansur test automation
13. ted in PDF format using any PDF software Additionally Fluke Biomedical developed The Switch Box and Return Electrode Current Monitor ing RECM Test Box Figure 1 that works with Ansur to leverage the internal footswitch capa bility of the QA ES e The Switch Box allows a differentiation between cut and coagulation commands The two modes can be selected using a switch instead of changing the wiring for each mode e RECM Test Box is intended to test the Return Electrode Current Monitoring alarm White Paper Biomedical Step by step ESU test guide using the Additionally each template can be custom QA ES Ansur Plug In Software ized to reflect the exact model to which it refers and those model specific inspection and testing There are several reasons why a biomedical steps required by the ESU manufacturer Because department should adopt an Ansur automated Ansur templates are stored in a PC there is no test solution For starters Ansur test automation limit to the number of PM procedures that can be allows users to precisely define each step in the automated PM process using a pre made template Pictures Automated procedures allow technicians and diagrams can be added to these templates with minimal training to successfully perform to provide a visual guide as shown in Figure 2 a PM with ease Users are guided step by step Specific service manual information can also be through the test while the software mini
14. verall test result was Pass Likewise an overall test status of Fail could trigger the CMMS database to extract the failed test results from the Ansur test result file It would then use that information to automatically open a new work assignment and populate the work assignment fields for problem reported Preventive maintenance on electrosurgical units How to increase productivity using test automation software Peak to peak voltage output When using a current transformer the RF signal is converted into a low voltage in order to be measured 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 volt age directly This measurement is useful when troubleshooting an ESU as some ESUs require a voltage measurement at low frequency which cannot be accomplished using a current trans former Such coils have a low end frequency response at about 40 kHz The QA ES can handle this measurement Summary The Ansur QA ES plug in supported on the Ansur software provides remote access to all func tionality of the QA ES Electrical Electrosurgical Analyzer A unique Ansur QA ES test element is available for each of the QA ES Electrical Electro surgical Analyzer measurements The Ansur automated QA ES software stream lines ESU preventive maintenance and allows users to increase productivity with the following functions e Step by step test templates includi
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