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APPENDIX L

Valleylab Recommended Test Procedure

22

(Source: Valleylab Force 2 Electrosurgical Generator Service Manual)

Copyright June, 2007 by BC Group International, Inc.

Author: Michael R. Erwine

46

Revision 1 – June 13, 2007

22

For their Force 2 Electrosurgical Generator, Valleylab recommends a current sensing test setup utilizing a Pearson Electronics Model 411 current

transformer and Dale NH-250 precision resistors. The Fluke 8920A is no longer available and is being replaced with the BC Biomedical ESU-2050.

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Summary of Contents for ESU-2000 Series Guide

Page 1: ...logy and Capability Is Here Copyright June 2007 by BC Group International Inc Author Michael R Erwine 1 Revision 1 June 13 2007 Your current ESU Analyzer just became obsolete no matter how new it is 3081 Elm Point Industrial Dr St Charles MO 63301 4333 USA BC Group International Inc ...

Page 2: ...eries PC Utility Software 16 One Picture is Worth a Thousand Words Or Up To 32 768 Data Points 16 See The Data You Want The Way You Want 17 Easy Setup and Operation 18 ESU 2050 Graphical Mode 18 Product Comparison Overview 18 One Stop Source We Make It Easy for You 19 Conclusion 20 ESU 2050 Product Specifications 21 ESU 2300 Product Specifications 22 Technical References 23 About the Author 24 APP...

Page 3: ...asic principles of electrosurgery technology Electrosurgery generally deals with electrical signal frequencies in the range of approximately 200 kHz to 3 3 MHz see Figure 1 This is well above the human body s inherent frequency range of susceptibility to the hazards of microshock Figure 1 Figure 2 Frequency Spectrum Showing Range Current Density Differences of Frequencies for Electrosurgery at Sur...

Page 4: ...n in Figure 6 Figure 5 Figure 6 Pure Cut Pure Sinusoidal Waveform Blended Waveforms The Coag mode see Figure 7 of an electrosurgical generator creates a waveform with large amplitude but short duration spikes to achieve hemostasis coagulation The surrounding tissue is heated when the waveform spikes and then cools down between spikes producing coagulation of the cells Fulguration is achieved in th...

Page 5: ...ned to constantly measure the integrity of the patient electrode site in order to minimize the possibility of high frequency burns at the patient electrode The varying technologies introduced by the various electrosurgical generator manufacturers over the years have generically become know in today s market as the Contact Quality Monitor CQM function see Figure 11 of the electrosurgical generator ...

Page 6: ...nce to earth ground this introducing the possibility of high frequency burns at the alternate earth ground contact point typically a concern in ground reference generators and not isolated output generators Coagulation the clotting of blood or destruction of tissue with no cutting effect electrosurgical fulguration and desiccation Cut Mode electrosurgical mode that produces a low voltage continuou...

Page 7: ...ve active type ESU analyzers available at time The RF 302 offered a better high frequency range than some competitive active units Bio Tek Instruments sold quite a few of these units in the market This instrument is very similar to the BC Biomedical ESU 2000A instrument that is still available today for those customers who prefer a legacy type RF ammeter passive instrument approach to ESU generato...

Page 8: ...rmation above under the RF 303RS Actual design development and manufacturing of the 402A and the RF 303 took place at the DNI Nevada Inc facility in Carson City NV under the ownership and management of Lionheart Technologies Inc In order to make the two products look sufficiently different and in order to somehow truly differentiate the two the 402A was given an RS232 communications port and the R...

Page 9: ...istor value to any of the internal load values or external only mode use only the value of the external load resistor The release of the new BC Biomedical ESU 2000 Series including the ESU 2050 and ESU 2300 analyzers represents a paradigm shift in the level of technology offered for electrosurgery generator testing ESU 2050 Truly Unique in the Market From its original product design proposal the n...

Page 10: ...d lighter and more resistant to breakage during shipment than the current industry available ESU analyzers In summary give us an instrument that we can use to test the way we have tested our electrosurgery generators over the past 10 years The result of these ongoing collaborative efforts over the past 18 months is the new BC Biomedical ESU 2050 analyzer with never before seen levels of accuracy a...

Page 11: ...ntional Approach For those customers that do not wish to make the quantum leap from conventional ESU testing methodologies to the new ESU 2050 platform the new BC Biomedical ESU 2300 analyzer offers a more conventional approach to ESU testing The ESU 2300 utilizes some of the best attributes of the ESU 2050 design Patent pending DFA Technology Industry standard current sensing technology via a cus...

Page 12: ... discrete data points ESU 2050 ESU 2300 Precision Load Resistors Are Where Accuracy Starts If there is another industry standard among manufacturers of electrosurgery generators it is the precision load resistors that are commonly used in their manufacturing testing service and calibration functions That is why we chose the exact same external load resistors for use with our new BC Biomedical ESU ...

Page 13: ...e very best companies in the market today We chose to utilize their current sensing transformers with both the ESU 2050 and ESU 2300 analyzers Figure 15 External Current Sensing Toroid Transformer by Pearson Electronics The BC Biomedical ESU 2050 utilizes an external transformer The Pearson Model 411 0 1 1 ratio and Model 4100 1 1 ratio are the specified transformers for use with the ESU 2050 Thes...

Page 14: ... Biomedical Model 454A the BC Biomedical ESU 2050 and ESU 2300 ESU analyzers are now the only commercially available analyzers on the market today utilizing industry standard current sensing technology Ensuring Quality By Taking Care Of The Details Sometimes it comes down to the little things that ensure accuracy and a long lasting life to your ESU analyzer Things like selecting the right load res...

Page 15: ...re two manufacturers that offer electrosurgical generators with pulsed waveforms Typically these pulsed waveforms have long single cycle time periods within which a signal is pulsed for a brief period of time This results in a very low duty cycle waveform that is extremely difficult to measure let alone measure accurately Figure 16 Figure 17 Conmed Spray RF Waveform Conmed Spray Pulsed Waveform Fi...

Page 16: ...ESU 2300 See Appendix M for sample screen shots form the utility software One Picture is Worth a Thousand Words Or Up To 32 768 Data Points We ve all heard the old adage that one picture is worth a thousand words The new BC Biomedical ESU 2050 analyzer puts some technological reality to this statement for the first time in ESU testing history Through utilization of the ESU 2000 Series PC Utility S...

Page 17: ...See The Data You Want The Way You Want Both the BC Biomedical ESU 2050 and ESU 2300 offer the capability of multiple parameter screens for viewing test measurement parameters The ESU 2050 allows you to select screens with 1 to 5 measurement parameters for display You can even select which parameters you want displayed in each window of the screen For user convenience the value of load resistance i...

Page 18: ...The BC Biomedical ESU 2050 offers a graphical mode in which you can easily view the captured electrosurgical generator waveform You can even zoom in on the waveform for a closer look and save it to any one of three storage locations Stored waveforms can have up to 32 768 discrete data points Figure 24 The ESU 2050 Graphical Mode Offers Advanced Capabilities Up to three captured waveforms can be sa...

Page 19: ...wer watts Peak Voltage RMS Voltage RMS Current Crest Factor Test Load Ω Power watts RMS Current Test Load Ω Power watts RMS Current Peak to Peak Voltage Crest Factor Test Load Ω Power watts RMS Current Test Load Ω Power watts RMS Current Peak to Peak Voltage Crest Factor RS232 Communications Port Yes Yes Yes Yes Yes USB Communications Port Yes Yes No No No Battery Operation No Yes No Yes No Pulse ...

Page 20: ... old technology base products Innovative new products are what we are all about not new photography and product overlays We ll let those types of development efforts up to our competitors We hold the technology needs of our customers in the highest regard and we are confident that our ongoing development efforts in cooperation with some of the medical device industry s most significant players wil...

Page 21: ...MPATIBILITY RF Current Transformer 50 ohm Pearson Electronics 411 or 4100 Typical RF Current Transformer Attenuation 0 1 1 or 1 1 User Selectable OTHER Display LCD Graphical 128 x 64 Pixels with Backlight Setup Memory EEPROM All Parameters Memory Retention 10 Years without Power Operating Range 15 to 30 Degrees C Storage Range 40 to 60 Degrees C Construction Enclosure ABS Plastic Face Lexan Back P...

Page 22: ...Limits Ventilation Internal Fan variable speed over temperature protected Fan rotor sensor Bandwidth 10 kHz to 10 MHz Oscilloscope Output Isolated uncalibrated BNC Connector Crest Factor 1 4 to 500 Setup Memory EEPROM All Parameters Voltage 10 000 Peak Memory Retention 10 Years without Power Operating Range 15 to 35 Degrees C Loads Storage Range 40 to 60 Degrees C Main Test Load Humidity Limit 90 ...

Page 23: ...dical Tyco Healthcare Valleylab Force 2 Electrosurgical Generator Service Manual Copyright 2004 Tyco Healthcare Valleylab Force FX Electrosurgical Generator Service Manual Copyright 2006 Tyco Healthcare Valleylab LigaSure Vessel Sealing System Service Manual Copyright 2004 Electrosurgical Generators Guide to Performance and Safety Testing ISBN 09661128 1 4 Copyright Tektran Incorporated Available ...

Page 24: ...ternational Sales Manager Strategic Accounts Manager VP of Sales Marketing Executive Vice President General Manager In the electrosurgery testing specialty area Mr Erwine has interfaced and worked with major medical device manufacturers such as Tyco Healthcare Valleylab Conmed Electrosurgery Division Erbe USA Bovie etc While at Dynatech Nevada Inc Mr Erwine successfully launched the industry icon ...

Page 25: ...om various sources within the public sector and do not represent confidential information or trade secrets of any kind Recognition of ownership and copyright is hereby given to the companies and manufacturers whose product and other types of information are represented here in this document for informational purposes Original ownership and copyright of this documentation remains with these compani...

Page 26: ...DIX A Fluke Biomedical 454A Instrument Specifications Source Fluke Biomedical Model 454A Operating Manual Copyright June 2007 by BC Group International Inc Author Michael R Erwine 26 Revision 1 June 13 2007 ...

Page 27: ...DIX B Fluke Biomedical RF 303RS Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Copyright June 2007 by BC Group International Inc Author Michael R Erwine 27 Revision 1 June 13 2007 ...

Page 28: ... Continued Fluke Biomedical RF 303RS Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Copyright June 2007 by BC Group International Inc Author Michael R Erwine 28 Revision 1 June 13 2007 ...

Page 29: ... Continued Fluke Biomedical RF 303RS Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Copyright June 2007 by BC Group International Inc Author Michael R Erwine 29 Revision 1 June 13 2007 ...

Page 30: ... Continued Fluke Biomedical RF 303RS Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Copyright June 2007 by BC Group International Inc Author Michael R Erwine 30 Revision 1 June 13 2007 ...

Page 31: ...APPENDIX C Dale Technology DALE3000 Instrument Specifications Source Dale Technology Product Catalog Copyright June 2007 by BC Group International Inc Author Michael R Erwine 31 Revision 1 June 13 2007 ...

Page 32: ...DIX C Continued Dale Technology DALE3000 Instrument Specifications Source Dale Technology Product Catalog Copyright June 2007 by BC Group International Inc Author Michael R Erwine 32 Revision 1 June 13 2007 ...

Page 33: ...APPENDIX D Metron QA ES Instrument Specifications Source Metron QA ES Product Data Sheet Copyright June 2007 by BC Group International Inc Author Michael R Erwine 33 Revision 1 June 13 2007 ...

Page 34: ...n 1 June 13 2007 14 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 Series...

Page 35: ...vision 1 June 13 2007 15 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 S...

Page 36: ... 1 June 13 2007 16 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 Series ...

Page 37: ...ision 1 June 13 2007 17 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 Se...

Page 38: ...une 13 2007 18 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 Series PC U...

Page 39: ...n 1 June 13 2007 19 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 Series...

Page 40: ...n 1 June 13 2007 20 Graphed data shown in the left hand set of illustrations above was automatically created by Excel as part of the normal data export from the ESU 2000 Series PC Utility Software No user knowledge of Excel for graphing purposes is required at this level The graphs on the right were individually created within Excel by the user based upon the data exported from the ESU 2000 Series...

Page 41: ...APPENDIX H Pearson Electronics Model 411 Data Sheet Source www pearsonelectronics com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 41 Revision 1 June 13 2007 ...

Page 42: ...APPENDIX I Pearson Electronics Model 4100 Data Sheet Source www pearsonelectronics com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 42 Revision 1 June 13 2007 ...

Page 43: ...APPENDIX J Vishay Dale NH 250 Data Sheet Source www vishay com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 43 Revision 1 June 13 2007 ...

Page 44: ...APPENDIX J Continued Vishay Dale NH 250 Data Sheet Source www vishay com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 44 Revision 1 June 13 2007 ...

Page 45: ...left hand portion of a graph that is automatically created during the data export process from the ESU 2000 PC Utility Software No knowledge of Excel is required to get this data and the resulting graph into Excel The measurement data shown above is abbreviated for illustration purposes The actual Excel spreadsheet created by the data export function contains a total of 32 768 rows of actual measu...

Page 46: ...ernational Inc Author Michael R Erwine 46 Revision 1 June 13 2007 22 For their Force 2 Electrosurgical Generator Valleylab recommends a current sensing test setup utilizing a Pearson Electronics Model 411 current transformer and Dale NH 250 precision resistors The Fluke 8920A is no longer available and is being replaced with the BC Biomedical ESU 2050 ...

Page 47: ...p International Inc Author Michael R Erwine 47 Revision 1 June 13 2007 23 For their Ligasure Vessel Sealing Generator Valleylab recommends a current sensing test setup utilizing a Pearson Electronics Model 411 current transformer and Dale NH 250 precision resistors The Fluke 8920A is no longer available and is being replaced with the BC Biomedical ESU 2050 ...

Page 48: ...hor Michael R Erwine 48 Revision 1 June 13 2007 24 For their Force FX C Electrosurgical Generator Valleylab recommends a current sensing test setup utilizing a Pearson Electronics Model 411 current transformer and Dale NH 250 precision resistors Measurement procedures are outlined as above The Fluke 8920A is no longer available and is being replaced with the BC Biomedical ESU 2050 ...

Page 49: ... Software Screen Shots25 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 49 Revision 1 June 13 2007 25 Version 1 1 shown software subject to change with new features and functionality added through routine updates ...

Page 50: ...ility Software Screen Shots26 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 50 Revision 1 June 13 2007 26 Version 1 1 shown software subject to change with new features and functionality added through routine updates ...

Page 51: ...res and functionality added through routine updates Copyright June 2007 by BC Group International Inc Author Michael R Erwine 51 Revision 1 June 13 2007 28 After the ESU waveform is exported from The ESU 2000 Series PC Utility Software to Microsoft Excel this file is automatically created No user knowledge of Microsoft Excel is required to create this file or the accompanying graph ...

Page 52: ...Our philosophy with BC Biomedical products runs counter to the current trend of one size fits all We offer families of products that provide the users with a choice of models so they can pick the features they need and at a price they can afford We are working closely with leading medical device manufacturers worldwide in the continuing development of new and innovative test and measurement produc...

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