10 Best Practices for Electrosurgical Unit Testing: Tips
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1. TechNatiamn Webinar gt Wednesday Jerry Zion presents 10 Best Practices for Electrosurgical Unit Testing Tips to quickly amp effectively test Sponsored by Fluke Biomedical Biomedical TechNatiamn Webinar gt Wednesday Wednesday July 15 2015 2 00pm EST PRESENTER JERRY ZION FLUKE BIOMEDICAL GLOBAL TRAINING MANAGER A renowned veteran in the medical device industry Jerry Zion has more than 35 years of experience working in many capacities for various medical device manufacturers Zion has spent the last decade at Fluke Biomedical pioneering the global training program Zion is an AAMI certified biomedical equipment technician and holds a Bachelor of Science degree in Electrical Engineering Technology from Purdue University Zion also obtained a Master s in Management in Science and Technology from the Oregon Graduate Institute White Paper Your copy is included in this workbook TechNation would like to thank our sponsor Fluke Biomedical Biomedical Fluke Biomedical is the premier global provider of test and measurement equipment and services to the healthcare industry We serve biomedical engineers quality assurance technicians medical physicists oncologists radiation safety professionals and are continually expanding our range of solutions to a broader range of health and safety professionals Visit www flukebiomedical com for more information These webina2. ce should be tested is a Manufacture recommended test procedures risk based method used by the University of VT should always be followed Refer to the service Biomedical Engineering Department As shown manual for performance inspection tasks in the table below this method is described in specific to the device These service manuals Medical Equipment Quality Assurance Inspec typically recommend an inspection frequency tion Program Development and Procedures by Complete the performance inspection per J Tobey Clark This method recommends a manufacturer s procedure bi annual every six months test frequency for electrosurgical devices 2 Adopt a consistent inspection frequency Additionally most major electrosurgical If the service manual and inspection proce device manufacturers recommend semi annual dure from the manufacturer is not available preventive maintenance testing to ensure the the frequency of inspection must still be performance of the unit Sample risk assessment Criteria choose 1 rating from each category Clinical function No patient contact Device may make contact with patient but function is non critical Device is used for patient diagnosis or direct monitoring Device is used to deliver direct treatment to the patient Device is used for a life support Physical risk Device poses no appreciable risk due to failure Device failure will result in low risk Device failure will result in inappropriate therapy misd
3. e ability simplified data extraction for reporting and reduced human error 9 Always archive test results The purpose of testing and producing test results is to have a continuing stream of data showing all changes in the performance and safety of the electrosurgery generator year over year Long term trending of this statistically relevant information provides the basis for predictive maintenance i e when the next repair is most likely to happen so that parts especially long lead time and costly parts can be ordered and received just in time for the repair event This saves money and increases the amount of time the medical device is avail able for use The best place to archive test result infor mation is in a database CMMS computerized maintenance management system Archiving paper into filing cabinets rarely results in anyone capturing or understanding the long term implications of failures Intended Use for the QA ES II The Product is a precision instrument for use in perform ing tests on high frequency electrosurgical units in accordance with national and international standards It is for use by trained service technicians Tests include automatic power distribution measurement crest factor measurement RF leakage measurement CQM con tact quality monitor test The Product will be used in hospitals clinical engineering departments independent service organizations and at ESU OEMs The Product will not b
4. e See Figure 2 Figure 1 Monopolar electrosurgery Figure 2 Bipolar electrosurgery 2 voltage Fluke Biomedical Biomedical Modes of Electrosurgery CUT vs COAG In blended cut mode the surgeon achieves a There are two types of cut modes blended cut and much wider incision by heating up the tissue and pure cut Pure cut is typically used for dissection letting it cool This is achieved by lower frequency only In pure cut mode the surgeon achieves a cut and higher voltage than pure cut that is very similar to an incision produced by a Coagulation is performed by using high volt medical scalpel The cut is narrow deep and the age and low frequency In COAG mode heat is surgeon has little or no control over bleeding As incapable of explosive vaporization therefore shown in Figure 3 this effect is obtained by high resulting in a thermal coagulum also known as a frequency and low voltage 100 On 80 on 20 off Low voltage Figure 3 Electrosurgical waveforms 10 Best Practices for Electrosurgical Unit Testing clot In COAG mode the surgeon has more control over bleeding because the tissue is allowed more time to cauterize in between contact 60 on 50 on 94 off 40 off 50 off 6 on High voltage 3 Fluke Biomedical 10 Best Practices for ESU Performance Testing 1 Always refer to the manufacturer s determined One method for determining how service manual often a medical devi
5. e used in patient rooms while a patient is present 5 Fluke Biomedical 10 Best Practices for Electrosurgical Unit Testing 10 Choose to test with an analyzer that you can depend on for complete preventive maintenance and safety testing The QA ES II Electrosurgery Analyzer is the ESU tester you can depend on for complete preventive maintenance and ESU safety test ing to test all critical functions The Ansur Automated QA ES analyzer streamlines ESU preventive maintenance and allows users to increase productivity with the following functions e Step by step test templates includes pic tures diagrams and hyperlinks e User friendly Ansur test automation functionalities e Checklists and user messages e Automatic power distribution measurement including power output power current peak to peak voltage and crest factor measurements QA ES II Electrosurgery Analyzer To learn more about the QA ES II Electrosurgery Analyzer or any other medical test equipment mentioned in this document click here or visit flukebiomedical com Fluke Biomedical Trusted for the measurements that matter 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 2014 Fluke Biomedical Specifications subject to change without notice Printed in U S A 1 2015 6004312A EN Modifica
6. iagnosis or loss of monitoring Device failure could result in severe injury to or death of patient or user Problem avoidance probability Maintenance or inspection would not impact reliability of the device Common device failure modes are unpredictable or not very predictable While common device failure modes are not very predictable device history indicates that TSP testing frequently detects problems Common device failure is predictable and can be avoided by preventive maintenance Specific regulatory or manufacturers requirements dictate preventive maintenance or testing Incident history 1 2 3 4 5 No significant history l 2 A significant history of incidents exist Manufacturers regulatory requirements for specific schedules Io requirements SSCS There are requirements Tor testing independent ofa numerical rating system 2 4 4 2 2 1 10 Best Practices for Electrosurgical Unit Testing Biomedical 3 Adopt a formal standardized test procedure If the service manual and inspection procedure from the manufacturer is not available it is still the responsibility of the medical facility to choose and standardize on a test procedure It is important that the electrosurgery generator functionality be quantitatively evaluated by comparing it to the manufacturer s specifica tions or the requirements in the applicable medical device standard When the medical device manufacturer s specifications are not know
7. n the IEC standard requirements are a reasonable substitute Once the inspection cri teria have been agreed no changes should be made without a rationale statement describing why a change was required what the change is and how this change was validated 4 Pair additional test equipment with your electrosurgical analyzer for comprehensive testing Most manufacturer performance inspection procedures require electrical safety tests including ground wire resistance and chassis leakage Keep an electrical safety analyzer close by to complete the electrical safety por tion of the performance inspection easily Additionally a medical oscilloscope can be used to show the actual wave shape of the device under test DUT This waveform output can be compared to the DUT s service manual Please see two possible solutions below ESA615 Electrical Safety Analyzer 190M Medical Oscilloscope 5 Be mindful of test leads while testing Keep all test leads and interconnecting leads as short as possible and do not cross or coil measurement leads Radio frequency energy behaves differently than low frequency energy It radiates and induces electrical current flow 4 Pluke Biomedical 10 Best Practices for Electrosurgical Unit Testing Biomedical in addition to any conductive current flow through test leads that cross and coiled leads When leads are too long they act more like an antenna than test leads Always exercise cau
8. ng through the return electrode plate or pad has been exceeded Inert gas flow and pressure parameters In some electrosurgery generators a special option allows an inert gas envelope to be produced encasing the surgery site so that oxygen is eliminated at that specific spot Oxygen causes charring of the tissue at the site of the surgery Eliminating oxygen prevents this charring and produces cleaner more precise incisions These more precise wounds heal faster with less opportunity for infection of the tissue Test the gas flow and pressure for such inert gas outputs 8 Use test automation to quickly perform tests document measurements and archive data One of the best ways to shorten learning curves for infrequently used test instruments and new or infrequently scheduled testing is to standardize the procedure Test standardization helps ensure all testing is completed in a consistent sequence recorded and archived accurately and meets regulatory requirements Test automation can also drastically reduce test time According to Medical Equipment Quality Assurance Inspection Program Devel opment and Procedures by J Tobey Clark the average test time for most electrosurgical unit tests is 35 minutes When coupled with the QA ES II Electrosurgery Analyzer Ansur Test Automation Software can reduce average test time to under 15 minutes Other benefits of using test automation to test electrosurgical units include easy data trac
9. rs have been VERY helpful They are usually spot on to what we need to know in our field For those of us who have to have Professional Engineering hours the CEU credits are very helpful too Ben W DON T MISS WEBINAR WEDNESDAY S Q amp A Jerry Zion will end today s presentation with a Q amp A session If you have a question for Jerry please submit it early by emailing webinar mdpublishing com All questions will be addressed at the end of today s presentation Let s start with the basics Electrosurgical units ESU use a high frequency electrical current to cut tissue and control bleed ing by causing coagulation Tissue resistance to the high density current causes a heating effect which results in tissue destruction Electrical current is delivered and received through cables and electrodes The electrodes may be activated by either a hand piece switch or a footswitch The ESU may use a monopolar or a bipolar mode wn Biomedical White Paper Monopolar vs Bipolar In monopolar mode electrical current is delivered to the patient via an active cable and electrode As shown in Figure 1 current returns to the unit through a return electrode pad or plate to disperse the return current thus preventing focused heat which can cause burns In bipolar mode two electrodes typically the tips of a pair of forceps or scissors serve as the equivalent of the active and dispersive leads in the monopolar mod
10. tion of this document is not permitted without written permission from Fluke Corporation Biomedical TechNati n Webinar gt Wednesday
11. tion when dealing with active electrodes Active electrodes present many dangers Do not touch the active electrode or return pad plate of the ESU while it is activated in either cut or coagulation mode Turn off the ESU before adjusting or removing connections Additionally be aware of other flammable hazards including alcohol oxygen and moisture Perform all tests necessary to ensure performance Power distribution output tests Power distri bution output tests measure the power output properties of the ESU and supply output current A power W peak to peak voltage V and crest factor values The power distribution test evaluates the output across multiple loads to determine how well the impedance sensing circuits of new generation electrosurgery generators automatically adjust the output of the ESU so that it is not reduced by the presented load High Frequency RF leakage current tests The RF leakage current in electrosurgical units is a critical parameter to measure because it may cause accidental burns in patients The particular standard for electrosurgical units IEC 60601 2 2 indicates the maximum RF leakage levels and defines the elements and their layout to do these measurements RECM tests The RECM return electrode cur rent monitor is the watch dog that alarms both audibly and visually and prevents the electrosurgery generator from energizing when the high limit threshold for current flowi
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