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1. Nickel Plated 0 188 0 010 Brass Nut 3 50 0 031 4 78 0 254 1 812 0 091 Stainless Steel Stud 88 90 0 787 Dia Typ 46 02 0 787 Le i emmmer wg a e Seem 1 125 0 031 A 28 58 0 787 A 71 42 0 787 2 25 0 010 z S __ 4445 0787 57 15 0 254 r E E E 375 0 031 T 12 24 9 52 0 787 0 989 0 031 0 188 0 031 0 770 0 015 UNC 2A 75 0010 25 12 0 787 4 78 0 787 19 56 0 381 Thd Typ 85 0 254 Typ Le 478 0 093 139 14 2 36 RH 250 NH 250 0 188 0 010 i 4 78 0 254 d d Dia Typ 1 4 20 2 125 0 031 rass Nut 4 UNC 2A Thd Typ Stainless Steel Stud man ir 0787 P kasse 1 25 0 062 31 75 1 575 3 0 031 Boch Ira LS Arper 76 20 0 787 5558 0 2 50 0 010 63 50 0 254 0 875 0 0104 22 23 254 L 1 25 0 062 0 250 0 031 pans pee 312 0 031 3 0 0010 31 75 1 575 6 35 0 787 MOE 7 92 0 787 76 20 254 Typ 3 875 0 010 98 42 0 254 gt 7 0 093 177 80 2 36 Document Number 30201 For technical questions contact ww2bresistors vishay com www vishay com Revision 09 Sep 04 123 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 43 Revision 1 June 13 2007 APPENDIX J Continued Vishay Dale NH 250 Data Sheet Source www vishay com RH NH Vishay Dale Wirewound Resistors Military MIL PRF 18546 Qualified
2. 1500 2000 Sample Valleylab Force 2 Blend 2 Cut Waveform 300 ohm Load 2000 1500 1000 500 Sample 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 PC Utility Software Copyright June 2007 by BC Group International Inc Author Michael R Erwine Revision 1 June 13 2007 APPENDIX F Continued Valleylab Force 2 Generator Output waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export Valleylab Force 2 Blend 3 Waveform 300 ohm Load Valleylab Force 2 Blend 3 Waveform 300 ohm Load 2000 4 2000 4 1500 A i 1500 1000 4 1000 gt 500 S 500 E E o 0 o 0 2 s 500 500 1000 r 4 1000 000 10000 18006 120000 29000 30000 35000 1500 3000 1500 I I i 1500 f 2000 2000 Sample Sample Valleylab Force 2 Coag Waveform 300 ohm Load Valleylab Force 2 Coag Waveform 300 ohm Load 1500 1500 1000 1000 500 500 4l m 04 T 1 ges i i H Oo E coo FJ WV t E 500 f E 500 o a a a 2 1000 2 1000
3. 2 0 d 10000 5000 20000 500b 30000 35000 gt 2800 2500 3000 3500 4800 4500 1500 I 1500 1 2000 4 2000 E 2500 4 t d 2500 L I 3000 3000 Sample Sample 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 Series PC Utility Software Copyright June 2007 by BC Group International Inc Author Michael R Erwine 37 Revision 1 June 13 2007 APPENDIX G Conmed System 5000 Output Waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export Conmed System 5000 Pure Cut Waveform Voltage mV cC 30 MO TER j VL TRIN 1 Ap Wi dy MLA AA MA il al al Ii d I MEN Wi dd 0 5000 10000 15000 20000 25000 30000 35000 Sample Conmed System 5000 Blend 1 Cut Waveform Voltage mV 15000 20000 25000 20000 35000 Sample Conmed System 5000 Blend 2 Cut Waveform HE H d In H H 5000 10000 15000 20000 25000 30000 35000 Sample Voltage mV Conmed System 5000 Pure Cut Waveform B HSH HH ra 1 uU v V y V V 3
4. Type RE Aluminum Housed Chassis Mount TECHNICAL SPECIFICATIONS PARAMETER UNIT RH RESISTOR CHARACTERISTICS Temperature Coefficient ppm C 100 for 0 19 to 0 990 50 for 1Q to 9 90 20 for 10Q and above Dielectric Withstanding Voltage Vac 1000 for RH 5 RH 10 and RH 25 2000 for RH 50 4500 for RH 100 and RH 250 V Q C Short Time Overload 5 x rated power for 5 seconds Maximum Working Voltage P X R 2 Terminal Strength Solderability 5 minimum for RH 5 and RH 10 10 minimum for all others MIL PRF 18546 Type Meets requirements of ANSI J STD 002 OperatingTemperature Range C 55 4 250 Insulation Resistance Q 10 000 Megohm minimum dry 1000 Megohm minimum after moisture test POWER RATING Vishay RH resistor wattage ratings are based on mounting to the following heat sink RH 5 and RH 10 4 x 6 x 2 x 0 040 thick aluminum chassis 129 sq in surface area RH 25 5 x 7 x 2 x 0 040 thick aluminum chassis 167 sq in surface area RH 50 12 x 12 x 0 059 thick aluminum panel 291 sq in surface area RH 100 and RH 250 12 x 12 x 0 125 thick aluminum panel 294 sq in surface area AMBIENT TEMPERATURE DERATING Derating is required for ambient temperatures above 25 C see the following graph Curves A B C apply to operation of unmounted resistors Curve D applies to all types when mounted to specified heat sink A RH 5 and RH 10 size resistor unmounted B RH 25 size resisto
5. 200 ohms 500 watts maximum d E i pre 5 E DTE D 180 hT I CREST FACTOR ae nome H 1 D E cipher 772 i E idcm 7H The higher of the two peak voltage od M ie g measurements ie used for computation d an ash MR d Aone HO dere RANGE 1 4 16 V peak V rms S on Scene Sie FOOT SWITCH OUTPUT The foot swilch oulpul triggers Uie measure Example of a printout ment after a programmed delay time Start test QA FS 9 Foot switch triggers 9 Delay time ms 9k Start measurement The delay time 15 between 200 ms and 4000 m PEAK TO PEAK VOLTAGE 0 la 10 KV closed load only 1095 Measurement 5 taken between the acbve and dispersive electrodes with closed laad only OSCILLOSCOPE OUTPUT D Valls mps uncalibrated ISOLATION 10 KV rentatian between MI and enclasure TEMPERATURE REQUIREMENTS 75 C io 63570 while opening DEG bor Tor storage DISPLAY Type LCD Alphanumene Tomat B mes by 40 characters Graphics mode 240 x G pixel matrix Display contral 5 F keys enter cancel and an encoder DATA INPUT OUTPUTS 2 Parallel printer port 1 Bi directional RS 232C 1 for Computer control POWER From 115 VAG to 240 VAC AEG Hz HOUSING Metal case DIMENSIONS D xW xH 355 mm x 242 mm x 132 mm WEIGHT 9 8 kg STANDARD ACCESSORIES User and Service manual RECOMMENDED PRINTERS HF Desk Jet Canon Rubble Jet or compatible QA ES MKII ORDERING INFORMATION Order na 14010 QA ES
6. As an example when testing the Conmed Excalibur Electrosurgical Unit in the monopolar output with the RF303 load set to 50 ohms the set value on the Conmed will correlate with the displayed value on the RF303 When in the Bipolar mode the RF303 will display higher than expected values up to 35 higher The same test performed on some current measuring analyzers will produce lower than expected values This is due to the difference in fundamental frequencies between the monopolar and bipolar modes In this case the Conmed operates at 500 kHz in monopolar mode and 1 MHz in bipolar mode When comparing readings measured with a V R device to readings measured with an I R device total measurement difference will likely be larger than 35 due to different methods of deriving power This does not mean that the RF303 is malfunctioning or in error Rather it reflects the different results the two measurement techniques will produce when the load deviates from the nominal value used in the power calculations It should be noted that most ESU manufacturers use the current measuring technique to calibrate production units Page 1 of 9 The information above is significant in two main areas First the explanation clearly indicates that when using the device in question the operator should expect measurement errors up to 3596 as compared to the industry standard current sensing technique Secondly it acknowledges that the industry accepted
7. Available for downloading as a PDF at www tektran com Understanding Electrosurgery Bovie Aaron Medical Publication MC 55 049 001 Rev 1 Copyright July 2003 Application Note Electrosurgical Analyzer Primer Copyright Fluke Electronics Fluke Biomedical Available for downloading as a PDF from the Fluke Electronics Fluke Biomedical website at http global flukebiomedical com busen support appnotes deftault htm ANSI AAMI HF 18 2001 Standard Electrosurgical Devices Copyright June 2007 by BC Group International Inc Author Michael R Erwine 23 Revision 1 June 13 2007 About the Author Michael R Erwine has been involved in the medical device industry since 1975 with his roots being in biomedical and clinical engineering Since January 2006 Mr Erwine has been employed by BC Group International Inc and is currently fulfilling multiple roles including Strategic Accounts Manager Worldwide Dealer Network Manager Product Manager as well as other functions He also manages the BC Group International Inc Western Regional Office in Carson City NV Since 1989 Mr Erwine has worked for or with under strategic alliances marketing partnerships corporate family structure etc the following major biomedical test and measurement manufacturers and service providers Spectrum Technologies Inc Elysburg PA Dynatech Nevada Inc Carson City NV Metron AS Trondheim Norway Bender GmbH Grunberg Germany Datrend Sy
8. 2 0 700 0 mV RMS 0 1 mV RMS 1000 0 mV 0 1 mV 10 kHz 10 MHz 0 5 mV lt 50 mV 196 of reading 50 mV up to 1 MHz 3 of reading gt 50 mV 1 to 10 MHz CALCULATED RANGES Current with 0 1 1 CT 7000 mA RMS Hesolution 1 mA Current with 1 1 CT 700 0 mA RMS Resolution 0 1 mA Wattage 999 9 Watts Resolution 0 1 Watt Crest Factor 1 4 to 500 Resolution 0 1 INPUT IMPEDANCE 50 Ohms INPUT COMPATIBILITY RF Current Transformer 50 ohm RF Current Transformer Attenuation OTHER Display Setup Memory Memory Retention Operating Range Storage Range Construction Size Weight Connections Power Supply Adapter Power Consumption Data Storage Internal Pearson Electronics 411 or 4100 Typical 0 1 1 or 1 1 User Selectable LCD Graphical 128 x 64 Pixels with Backlight EEPROM All Parameters 10 Years without Power 15 to 30 Degrees C 40 to 60 Degrees C Enclosure ABS Plastic Face Lexan Back Printed 3 4 H x 9 1 W x 8 0 D lt 3 lbs Input BNC Output Serial DB 9 or USB 6 VDC Center Positive 300 mA ON less than 150 mA OFF less than 40 ua 3 Sets of 32 768 Data Points Specifications are accurate as of the date of release of this document Specifications are subject to change without prior notice Copyright June 2007 by BC Group International Inc Author Michael R Erwine 21 Revision 1 June 13 2007 ESU 2300 Product Specifications Me
9. 2007 by BC Group International Inc Author Michael R Erwine 16 Revision 1 June 13 2007 Valleylab Force FX Desiccate Coag Waveform Voltage mV 1000 __ Om i iOc lt c_uo4 4 q 4wi q_ oe iwc m a ewuwme 500 1000 1500 2000 2500 3000 sample Figure 20 Microsoft Excel Graphical Plot of Exported Electrosurgery Generator Waveform With Zoom Manipulation of the Waveform Cycle A sample Microsoft Excel exported data set can be viewed in Appendix K This example illustrates the fundamental structure of the resulting Excel workbook but has been reduced significantly in size to allow display on a single page The original Excel workbook contains 32 768 rows of actual measurement data accompanied by a graph of the displayed data This Excel workbook is created automatically by the export function of the BC Biomedical ESU 2000 Series PC Utility Software No knowledge of Excel is required 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 is always displayed on the screen See Figure 21 below 100 0 Load m Figure 21 ESU 2050 Display the Number of M
10. ESU 2000 Series PC Utility Software Copyright June 2007 by BC Group International Inc Author Michael R Erwine 40 Revision 1 June 13 2007 APPENDIX H Pearson Electronics Model 411 Data Sheet Source www pearsonelectronics com PEARSON ELECTRONICS INC TM Sensitivity 0 1 Volt Ampere 1 0 PEARSON Output resistance 50 Ohms C U RRENT Maximum peak current 5000 A MON ITOR Maximum rms current 50A MODEL 41 1 Droop rate 0 9 millisecond Useable rise time 20 nanoseconds Current time product 0 2 Ampere second max Low frequency 3dB point 1 Hz approximate High frequency 3dB point 20 MHz approximate l f figure 0 6 peak Amperes Hz Output connector BNC UG 290A U Operating temperature 0 to 65 C Weight 8 3 ounces Maximum current time product can be obtained by using core reset bias as described in the Application Notes 0 06 Ampere second is typical without bias 2002 Pearson Electronics Inc 411 wpd 021011 8 52 THREADED HOLES 3 4 200 0 485 1 585 12 352 1 000 0 9 70 Pearson Electronics Inc 4009 Transport Street Palo Alto CA 94303 Telephone 650 494 6444 FAX 650 494 6716 www pearsonelectronics com Copyright June 2007 by BC Group International Inc Author Michael R Erwine A Revision 1 June 13 2007 APPENDIX I Pearson Electronics Model 4100 Data Sheet Source www pearsonelectronics com PEARSON ELECTRONICS INC PEARSON CURRENT MONITOR MODEL
11. Figure 3 is accomplished by using two parallel poles in close proximity where the flow of high frequency current is restricted to the two poles one being the source and the other being the return path A patient return electrode is typically not needed in bipolar electrosurgery applications and because these two poles are close together the Commercial availability scheduled for July August 2007 See Appendix L for specific information regarding Tyco Healthcare Valleylab recommended test setup procedures and recommended test equipment Sincere appreciation to Tyco Healthcare Valleylab for the use of the illustrations in this section Images and information are based upon the Valleylab publication Electrosurgery Self Study Guide Copyright September 1999 Authored by Brenda C Ulmer RN MN CNOR This Tyco Healthcare Valleylab publication can be downloaded in PDF format at http www valleylabeducation org pages list book html Copyright June 2007 by BC Group International Inc Author Michael R Erwine 3 Revision 1 June 13 2007 voltage level and resulting applied power are lower than in monopolar electrosurgical applications This results in less localized tissue heating and reduced charring of tissue Bipolar electrosurgery is typically used in neurosurgical and gynecological procedures and in other procedures where there is concern due to implanted pacemakers and automatic defibrillators In general bipolar elect
12. Gate 13 Product Development In Cooperation with ESU Manufacturers n nnannnnnnannnnnsennnensnnrrrnsnnrrenrnrrrnsrnrrrnnrrrrenrnnnrrennrnnrnnnnnrennnnnnen 14 Industry Standard Current Sensing Technology 13 Working With The Best In Current Sensing Pearson Electronics cccccccsseseececceeeeeeeeeeceeeeeeeeeeeeceeeeeesaueeeeeseeeeessaeaaeeeeeeeeseaas 13 Current Sensing vs Voltage Measurement nn rrrennen nn 13 Ensuring Quality By Taking Care Of The Details 0 ccccccccccccccsssseececeeeesaeeeeeeeeeeseaeeeeeceeeeeeeseseeeeeesssesaesaeeceeeessaeaaseeeeeeesseaageess 14 Those Crazy amp Exotic Pulsed WSS Luer 15 ESU 2300 External Load Capabilities Built Inhon Obeolescence 16 ESU 2000 Series PC Utility Software nnne nennen nnne nnn nnn nnn n niis ssssa sinis iss snas sinn sis assai nnns 16 One Picture is Worth a Thousand Words Or Up To 32 768 Data Points 000nnnnn0nannnenennnnnnennnnnnrnrrnnsrnrnnnnrnrnrrnsnnrrensnrrrennnne 16 See The Data You Want The Way You Want 17 ESPN 18 SS RH ET elle Mode EE 18 Product Comparison Cvervlew nrn nnrrrEneA Arrt EErEE SAA EErEE SE AAE ErEEn ennn E rrenen mnre een 18 One Stop Source We Make It Easy for ou 19 Con VE Tai NERONE 20 RAISIN 21 EP 22 FEAR 23 Bolle NN 24 APPENDIGES APPENDIX A Fluke Biomedical 454A Instrument Specifications rrrrrrrnnnnrrrrnnnnnrrnrrnnnnrenrnnnnrrrnrnnnnnrenrnnnnnrennrnnn
13. Inc Author Michael R Erwine 25 Revision 1 June 13 2007 APPENDIX A Fluke Biomedical 454A Instrument Specifications Source Fluke Biomedical Model 454A Operating Manual 454A OPERATING MANUAL RMS Power Peak to Peak Voltage Crest Factor Bandwidth Load Resistance Oscilloscope Output Temperature Range Power Requirements Display Case Weight Dimensions RMS Current 5 0 of reading 100 2000 mA 5 0 of reading 30 100 mA for Crest Factor lt 16 0 10 of range watts 10 of reading 0 10 kV 10 of reading 1 42CFS15 9 3 dB 30 Hz 7 MHz 50 1550 Q 50 0 steps 3 0 of selected load dc 2 5 volt amp uncalibrated Operating Storage 15 to 35 C 0 to 50 C lt 0 75 amps 115 VAC 50 60 Hz 240 VAC 50 60 Hz 4 lines X 42 characters 32 x 256 pixel matrix 0 5 H x 0 5 W numeric font Aluminum frame with polycarbonate front panel 7 71 kg 17 1b 46 36 cm L x 31 75 cm W x 15 24 cm H 18 25 L x 12 50 W x 6 00 H Copyright June 2007 by BC Group International Inc Author Michael R Erwine 26 Revision 1 June 13 2007 APPENDIX B Fluke Biomedical RF 303gs Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Instrument Specifications Parameter Specification Accuracy Modes of e Line Powered Battery Charge and Operation Maintenance Charge e Battery Operation e Offline Battery Charge and Maintena
14. Peak Voltage All functions and tests in O4 ES may be performed and Crest Factar Irem the PC SINGLE OPERATION instant measurement of Power Current Peak Voltage and Crest USER PROGRAMMABLE TEST SEQUENCES Factor Allows unlimited numbers ol test sequences with POWER DISTRIBUTION automate measure user programmable templates and test limits These ment ol Power Current Peak Vollage and tests include Power distribution test Output test HF Crest Factor threw a user selectable land leakage and RECOM verification range RF LEAKAGE current fom active disperse or STORAGE AND RECALL bipolar electrodes using one or 2 loads Protocol formats and data may be stored recalled RECOM best the Return Electrode Control printed out or transferred to D base systems Duality hMorabaring using lhe OA ES internal loads MODES OF OFERATION Manual user programmable or remote controlled wa RS 242 PRINT OUT MEASUREMENT VETR M OA Ez E4CFOSU D HLE Ansvar Ver ve I rue RMS value ol applied vwavelarm DER Sara na Extech RMS BANDWIDTH 30 Hz to 10 MHz 3 dB Ace z ck Tau na tuna LOW FREQUENCY FILTER m 100 Hz filter to avoid low frequency Var iacu disturbance interference CURRENT 20 mA ta 2200 mA LIII Livi ades beet L trzcwc n CURRENT ACCURACY 20 2200 mA 22 of reading LOAD RESISTANCE 10 2500 ohms instep of 25 ohms iz dc 2600 5200 ohms in step of 100 ohms i dc 1 1D chem ADDITIONAL FIXED LOAD du Race AM 78 Shere
15. Series PC Utility Software Screen Shots RMS Waveform Measurement Ver 1 1 m File Help mV RMS 591 mA RMS Power Watts 20 0 sw 200 399 Stored waveform Get Voltage Start E Graph Data i Read Manual Scale my 50 iw Auto Scale Graph n Statistics rr RMS Waveform Measurement Ver 1 1 Ele Help mV RMS ET vm mA RMS Power Watts Stored Waveform Get Voltage Start E Graph Data 1 v Read Manual Scale mv 50 w Auto Scale Version 1 1 shown software subject to change with new features and functionality added through routine updates Copyright June 2007 by BC Group International Inc Author Michael R Erwine 50 Revision 1 June 13 2007 APPENDIX M Continued ESU 2000 Series PC Utility Software Screen Shots RMS Waveform Measurement Ver 1 1 File Help mV RMS Do er mA RMS Power Watts 36 0 360 129 8 Stored Waveform Get Voltage e Start E W Graph Data i Read Manual Scale mV 50 jw Auto Scale e e a m X Microsoft Excel ESU COMMED PinPointCOAG75 xls Jeg File Edit View Insert Format Tools Data Window Help FFF D c E 64 X am x z ue EL 0 BIUEZEZB sS u 0 5 95 A AT E 1 Se cms oO m E G H J K L M N ESU 2050 Sampled Data 1 2 Date 6 12 2007 3 Time 9 24 26 AM ESU 2050 Data Samples Sample Voltage 34 70092773 35 49560547 36 2902832 37 87963867 39 20410156 40 26367188 40 79345703 41 05834961 40 793
16. normal practice by electrosurgery generator manufacturers is the superior current sensing technique With the discontinuance of the Fluke 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 resistors and relays that switch in and out individual load resistors in the internal load bank can make a big difference The ESU 2300 utilizes switching relays rated at 10 000 volts isolation 3 amps 7500 volts switching The leading competitive high end analyzer on the market utilizes relays that are rated significantly lower than this The ESU 2300 utilizes internal precision load resistors that are rated at 1 tolerance DC with a power dissipation rating of 225 watts The leading competitive high end ESU The complete User Manual Update can be downloaded in PDF format form the manufacturer s web site at the following url http global flukebiomedical com busen support manuals default htm Copyright June 2007 by BC Group International Inc Author Michael R Erwine 14 Revision 1 June 13 2007 analyzer on the market utilizes resistors that are rated at 596 tolerance DC with a power dissipation r
17. range call the Valleylab Service Center 5 18 Force FX C Service Manual 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 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 48 Revision 1 June 13 2007 APPENDIX M ESU 2000 Series PC Utility Software Screen Shots BR Y RMS Waveform Measurement Ver 1 1 m File Help mV RMS HE none mA DME Power Watts Preparing Data Load 28 e ES Please Wait 2 9 5 p Get Voltage Stark w Grip ooa manaa a Cale mV Graph Vos Statistics rm 75 Range Average Zoom In Ce HL LIE RMS Waveform Measurement Ver 1 1 File Help mV RMS 1187 SEG mA RMS Power Watts 286 286 82 03 Stored Waveform Get Voltage Start W Graph Data 1 Read Manual Scale my 50 i Auto Scale SoA 3 Version 1 1 shown software subject to change with new features and functionality added through routine updates Copyright June 2007 by BC Group International Inc Author Michael R Erwine 49 Revision 1 June 13 2007 APPENDIX M Continued ESU 2000
18. technology in our new ESU 2000 Series products The simple fact is that current sensing is more accurate and more reliable than voltage measurement when it comes to ESU analyzers But don t just take our word for it Ask your favorite electrosurgery manufacturer which technology they approve and use Working With The Best In Current Sensing Pearson Electronics When it comes to sensing high frequency current flow Pearson Electronics www pearsonelectronics com is one of the 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 These are the exact same transformers currently used by many major electrosurgery generator manufacturers Data sheets for these transformers can be seen in Appendices H amp I For customer convenience these external transformers are available directly from BC Group International Inc The BC Biomedical ESU 2300 utilizes an internal custom designed current transformer manufactured specifically for BC Group International Inc by Pearson Electronics Current Sensing vs Voltage Measurement The simple voltage measurement technique utilized by many competitive ESU analyz
19. the date of release of this document Specifications are subject to change without prior notice Copyright June 2007 by BC Group International Inc Author Michael R Erwine 27 Revision 1 June 13 2007 Technical References Tyco Healthcare Valleylab Electrosurgery Self Study Guide Copyright Tyco Healthcare Valleylab September 1999 Author Brenda C Ulmer RN MN CNOR Fluke Biomedical DNI Nevada Model 454A Electrosurgical Analyzer Operating Manual Copyright Fluke Electronics Fluke Biomedical Fluke Biomedical Bio Tek Instruments RF 303 Electrosurgical Analyzer Operator s Manual Copyright September 1998 Fluke Electronics Fluke Biomedical Metron QA ES Operator s Manual Copyright Fluke Electronics Fluke Biomedical DNI Nevada Model 402A Operating Manual Copyright Fluke Electronics Fluke Biomedical Dale Technology DALE3000 Instruction Manual Copyright Fluke Electronics Fluke Biomedical 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 09661 128 1 4 Copyright Tektran Incorporated Available for downloading as a PDF at www tektran com Principles of Electrosurgery ISBN 0 9661128 0 6 Copyright Tektran Incorporated
20. 0 1200 1400 Valleylab Force FX Spray Coag Waveform 2500 1000 1500 2000 3000 3500 Sample 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 Utility Software 35 Copyright June 2007 by BC Group International Inc Author Michael R Erwine Revision 1 June 13 2007 APPENDIX F Valleylab Force 2 Generator Output waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export 6 Valleylab Force 2 Pure Cut Waveform 300 ohm Load 1500 4 1000 1 500 Voltage mV e 500 1000 gt 0 5000 10000 15000 20000 25000 30000 1500 Sample Valleylab Force 2 Blend 1 Cut Waveform 300 ohm Load 2000 1500 1000 Voltage mV Sample Valleylab Force 2 Blend 2 Cut Waveform 300 ohm Load 2000 Voltage mV Sample 35000 Voltage mV Valleylab Force 2 Pure Cut Waveform 300 ohm Load 1500 4 1000 4 0 200 400 600 800 1000 1200 Sample Voltage mV Voltage mV Valleylab Force 2 Blend 1 Cut Waveform 300 ohm Load 2000 1500 1000 500 1000 4
21. 1000 1500 2000 2500 2000 Sample Sample Voltage mV Voltage mV 1000 t 1 D 5000 10000 15000 20000 25000 30000 35000 i 1500 Sample Sample T T 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 Utility Software Copyright June 2007 by BC Group International Inc Author Michael R Erwine 34 Revision 1 June 13 2007 APPENDIX E Continued Valleylab Force FX Generator Output Waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export 1000 4 Valleylab Force FX Fulgurate Coag Waveform 500 Voltage mV 1000 1500 5000 10000 15000 20000 25000 Sample 30000 35000 800 Valleylab Force FX Spray Coag Waveform 600 400 200 200 400 600 800 Voltage mV 1000 1200 9 000 10000 15000 70000 000 1400 odoo 35900 Sample Voltage mV 1000 4 1000 1500 Valleylab Force FX Fulgurate Coag Waveform 1500 2000 2500 Sample Voltage mV 800 4 600 400 200 4 200 4 400 4 600 800 4 100
22. 4100 Sensitivity Output resistance Maximum peak current Maximum rms current Droop rate Useable rise time Current time product Low frequency 3dB point High frequency 3dB point Ur figure Output connector Operating temperature Weight 1 Volt Ampere 1 0 50 Ohms 500 Amperes 5 Amperes 0 09 microsecond 10 nanoseconds 0 002 Amp second max 140 Hz approximate 35 MHz approximate 0 006 peak Amperes Hz BNC UG 290A U 0 to 65 C 8 0 ounces Maximum current time product can be obtained by using core reset bias as described in the Application Notes 0 0006 Ampere second is typical without bias 1999 Pearson Electronics Inc 4100 SPX 990506 8 52 THREADED HOLES 7 En EM D LI D LI U rn 0 485 ee ZE cS 2 DQ ON 1 585 WO d Zee SIC bise Q 1 000 2 155 0 970 a e a 2 119 Pearson Electronics Inc 4009 Transport Street Palo Alto CA 94303 Telephone 650 494 6444 FAX 650 494 6716 www pearsonelectronics com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 42 Revision 1 June 13 2007 APPENDIX J Vishay Dale NH 250 Data Sheet Source www vishay com Gy VSHAY RHANH Wirewound Resistors Military MIL PRF 18546 Qualified Vishay Dale Type RE Aluminum Housed Chassis Mount DIMENSIONS RH 5 10 25 50 NH 5 10 25 50 RH 100 NH 100
23. 45703 Pt a 10 41 58813477 A TETTE 12 42 11791992 41 85302734 um AA OO OO JO Cn FWHM Voltage mV 15 4211791992 16 41 32324219 17 41 05834961 18 39 9987793 5000 10000 15000 20000 25000 30000 35000 19 3973388672 20 38 93920898 21 37 34985352 22 37 08496094 23 3523071289 24 3443603516 25 33 64135742 M 4 gt DIN Sheet1 Sheet2 Sheet3 lt Ready Sum 250667935 5 l NUM Microsoft Excel File Screen Shot See Footnote Sample La N steps spe ess rises rele o o LA Version 1 1 shown software subject to change with new features and functionality added through routine updates 8 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 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 51 Revision 1 June 13 2007 APPENDIX N History of BC Group International Inc BC Group was founded in 1988 The company was formed as a sales and service organization to handle the test equipment needs of the worldwide biomedical engineering community Originally BC Group sold only test equipment manufactured by other companies Then in 2000 we began manufacturing our own product line under the now familiar Green and Gold BC Biomedical brand In January of 2005 Lloyd Ind
24. A ES version of this analyzer Fluke Biomedical instrument specifications can be found on the manufacturer s web site BC Biomedical ESU 2050 With commercial availability scheduled for July August 2007 the new BC Biomedical ESU 2050 represents a paradigm shift in ESU analyzer technology allowing customers to test their electrosurgical generators in exactly the same way as the electrosurgery manufacturers do With unprecedented 196 of reading accuracy the ESU 2050 is the most accurate ESU analyzer on the market offering advanced level features and functionality such as exporting waveform data sets with up to 32 768 data points to Microsoft Excel for graphing and analysis Patent pending DFA Technology BC Biomedical ESU 2300 With commercial availability scheduled for July August 2007 the new BC Biomedical ESU 2300 is a conventional design mid range ESU analyzer utilizing internal precision load resistors Unlike other mid range analyzers on the market the ESU 2300 utilizes industry standard current sensing technology for improved accuracy and reliability Like the ESU 2050 the ESU 2300 utilizes patent pending DFA Technology The ESU 2300 offers the ability to connect an external load resistor thus ensuring the availability of the required test load no matter what the value is External load resistors can be used in additive mode add the external load resistor value to any of the internal load values or external only mode use only th
25. BC Group International Inc 3081 Elm Point Industrial Dr St Charles MO 63301 4333 USA a E Gas i gt Y Al e rA vr KN X ON e Zi 1 m i j Dei Dm rr e 1 ti wu ue uw ig TM YOUR ONE STOP BIOMED SHOP ESU 2000 Series Product Overview A Paradigm Shift In Electrosurgery Testing Technology and Capability Is Here WIE sooo Watts Load 5000S MAN III Valleylab Force FX Blend Cut Waveform Voltage mV e 400 HHS 0 500 1000 1500 2000 2500 3000 Sample e mA Watts External DISPLAY RECOM HOLD SELECT SETUP Your current ESU Analyzer just became obsolete no matter how new it is Copyright June 2007 by BC Group International Inc Author Michael R Erwine 1 Revision 1 June 13 2007 The Next Generation in ESU Testing is Finally Here 3 Electrosurgery 101 A Basic Review of Electrosurgery ccccseecccceeeeeceeeeeeseeeeecaeeeeeseeeeseaeeeeesaeeeesaaeeeessaneeesseeeeseneeesseneeesagees 3 ESU Testing 101 Some Tesing HIStory MP ETE 7 ESU 2050 Truly Unique in the Market 9 ESU 2050 A Replacement for the Discontinued Fluke 8920A Instrument 11 ESU 2050 Unprecedented 1 Accuracy in ESU Testng ria E aE EEA EEEE EEREN 11 ESU 2300 A More Conventional Approach 11 ESU 2400 More High End Technology to Come 11 Common Element Patent Pending DFA Technology 11 Up TO 32 768 Data dela cR TR mE 12 ESU 2050 Precision Load Resistors Are Where Accuracy
26. Capabilities Built In Non Obsolescence The most common shortcoming of any commercially available ESU analyzer is not having the correct load resistor value available for the specific electrosurgery generator to be tested No matter how many internal loads are designed into a conventional ESU analyzer you can be sure that one of the electrosurgery generator manufacturers will eventually come along and specify a load that is not in the mix Thats why we designed external load resistor capability into our new ESU 2300 analyzer Not only does the ESU 2300 allow you to connect an external load but you have the option of adding this external load value to the internal load selected additive mode or simply using the external load for its actual value external only mode Our ESU 2050 relies on external load resistors so obsolescence due to unavailability of a specific test load is not at all possible ESU 2000 Series PC Utility Software Our BC Biomedical ESU 2000 Series Utility Software enhances the use of your BC Biomedical ESU 2050 and ESU 2300 analyzers When used with the ESU 2050 the software allows for export of the saved digitized waveforms from the ESU 2050 to an Excel workbook for further analysis It also supports remote operation of the ESU 2050 and 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
27. Frequency Leakage Current Test Load 1k ohm parallel 0 15 pF e 30 pF 20 6kV Ceramic Capacitor soJnpeooJd eoueuejurej Power Up Self Test Plug the generator into a grounded receptacle do not use extension cords and or adapter plugs Turn the power on using the On Off switch on the rear panel The generator will conduct an internal self test during which a tone sounds digital displays show 8 s and indicators illuminate Ensure that all digit segments mode alert and power indicators illuminate If any of these indicators do not illuminate return the generator for service In five to seven seconds following the self test the generator enters the standby mode with the digital displays showing dashes Press the READY button to place the generator into service The power setting displays indicate one watt and the MONOPOLAR FOOTSWITCH indicator illuminates Force 2 Service Manual 6 3 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 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 46 Revision 1 June 13 2007 APPENDIX L Continued Valleylab Recommended Test Procedure Source Valleylab Ligasure Vessel Sealing Generator Service Manual Testing the G
28. Group International Inc Author Michael R Erwine 52 Revision 1 June 13 2007
29. MEIN Electrosurgical Analyzer Accessorles 14100 Carrying Case 10500 Carrying Case ext printer 14200 ansur GA ES Plug In 14201 ansur QA ES Plug In demo 14225 User manual anser 14 E5 Plug In CD 14025 User Service manual GA ES CL 11451 E Input Measuring Cable 2m black 11452 E Input Measuring Cable 2m red 11481 F Input Measuring Cable Sm black 11482 E Inpul Measunmyg Cable Sm red 11471 Grp C black 11472 Grip C red MTLDASUT 02 13 In the interest of product improvement Metron claims the right to aller specifications without notice ME TReN www metron biomed com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 33 Revision 1 June 13 2007 APPENDIX E Valleylab Force FX Generator Output Waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export Vallaylab Force FX Pure Cut Waveform Vallaylab Force FX Pure Cut Waveform 400 Tl Mi t S PT oll LUTTE tn tm ER 100 E ZS 300 ry Vy Vey Ppp eee i 400 4 500 r 500 M S E 0 5000 10000 15000 20000 25000 30000 35000 500 1000 1500 2000 2500 3000 Sample Sample pt Vallaylab Force FX Blend Cut Waveform Valleylab Force FX Blend Cut Waveform 600 600 j LA O I MU d E ae e i E i l B ooo aM 600 eg T 600 z e F 1 5000 10000 15000 20000 25000 20000 35000 D 500
30. TORE THE CURRENT LJAVEFORH Location 1 Location 2 Location 3 RETURA CAMCEL gt AVE STORE Figure 24 The ESU 2050 Graphical Mode Offers Advanced Capabilities Up to three captured waveforms can be saved in the ESU 2050 for export to the ESU 2000 Series PC Utility Software at any time The ESU 2000 Series PC Utility Software also works with the ESU 2300 See Appendix M for some screen shots of the ESU 2000 Series PC Utility Software in action Copyright June 2007 by BC Group International Inc Author Michael R Erwine 18 Revision 1 June 13 2007 Product Comparison Overview A brief overview of the BC Biomedical ESU 2000 Series as compared to leading competitive products on today s market is as follows Feature Product BC Biomedical BC Biomedical Fluke Fluke Metron QA ES Biomedical Biomedical amp 454A RF303RS Fluke Discontinued Biomedical QA ES Industry standard current sensing No No technology Voltage Voltage Measurement Measurement High speed digital waveform processing and analysis Patent Pending Patent Pending DFA DFA Technology Technology Store digitized high resolution ESU No No No waveforms R Excel Internal load resistors External load resistor capability Yes Yes Yes No No Proprietary Load Modules Only m l Perform Test Externally using 1 1 Current Transformer CQM Testing Internal No Yes Yes Yes Yes Perform Limited Limited Limited Externally per OEM Spec
31. Type LCD 7 segment e Display size 4 full digits e Overall display size 2 0 x 0 75 RF303 Operator e Manual 1 5 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 29 Revision 1 June 13 2007 APPENDIX B Continued Fluke Biomedical RF 303gs Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Parameter Front Panel Controls Push buttons Top Panel Input Connections Side Input Connection Oscilloscope Output Calibration Period 1 6 Specification Accuracy e Measurement Select 1 e Load Select Increment test load one step Decrement test load one step e Designations Generator output active 1 Generator output dispersive 2 Signal earth ground reference 2 Auxiliary HF leakage load 2 e Connector type 4mm 0 160 diameter safety sockets e Input voltage limit 10 000 V peak e Input current limit 3 amperes RMS e Installation category II Designation Signal reference e Transformer coupled output e Scale Factor uncalibrated e Connector Type BNC Calibration recommended every 12 months Specifications Copyright June 2007 by BC Group International Inc Author Michael R Erwine 30 Revision 1 June 13 2007 APPENDIX C Dale Technology DALE3000 Instrument Specifications Source Dale Technology Product Catalog DALE3000 Ce Electrosurgical Analyzer Simple portable and digital to satisfy your elec
32. arrying case Service Manual Specifications Modes of Operation Manual Remote Simplex Transmits data only Duplex Transmits data and receives control commands HF SURGICAL EQUIPMENT ACTIVE X Moconnection DALE3000 ELECTROSURGICAL ANALYZER Test load NEUTRAL 1 SUPPLY EARTH Contact Quality Monitor 14 31 Displayed Parameters Power W RF current mA Test load Q Tests Performed Generator Output HF RF Leakage Performs tests in accordance with IEC 601 2 2 1289 2 ANSI AAMI HF 18 Earth Referenced Leakage IEC Type BF Test 1 Type BF Test 2 Isolated Output Leakage IEC amp ANSI AAMI Type CF Bipolar Test 3 Contact Quality Monitor CQM Measurement Technique A precision high voltage high frequency capacitive divider samples the applied ESU signal This voltage and the selected test load resistance value are utilized to derive the True RMS current and power values of the applied electrosurgical signal EQUIPMENT Load from active electrode to earth 1 800 544 3253 www daletech com Copyright June 2007 by BC Group International Inc Author Michael R Erwine Revision 1 June 13 2007 APPENDIX C Continued Dale Technology DALE3000 Instrument Specifications Source Dale Technology Product Catalog RF Measurements Watts Resolution Range 0 1 to 400 0 1 W Maximum power input 400 W Accuracy 5 of reading or 3 W whichever is greater RF Current Resolutio
33. assive technology in an ESU Analyzer refers to an instrument that does not require any external power source and simply meters the RF energy without any electronic signal processing Active technology is an ESU Analyzer refers to an instrument that requires a power supply and has active electronic circuitry including components such as A D converters Operational amplifiers thermal converters etc Copyright June 2007 by BC Group International Inc Author Michael R Erwine 7 Revision 1 June 13 2007 Dynatech Nevada Model 454A Until it was recently discontinued by Fluke Biomedical the Model 454A is no longer listed on the Fluke Biomedical web site and customers report having been informed that the 454A is no longer available from Fluke Biomedical in favor of the more recent Metron QA ES re branded as the Fluke Biomedical QA ES effective March 18 2007 the 454A was probably the most popular and successful ESU analyzer on the market Originally designed by Dynatech Nevada Inc the 454A utilized industry standard current sensing technology and offered accuracies of 596 of reading on RMS current and 1096 of range on RMS power For the the past decade the 454A was considered to be an electrosurgery industry icon but despite this status in the market it never really attained any level of actual customer recommendation for any of the leading electrosurgery generator manufacturers See Appendix A for full specifications on the discontinued Mod
34. asurement Physical Method Industry Standard Current Enclosure 6 0 x 13 5 x 12 0 Sensing Using RF Current Transformer Pearson Coil Power Weight 12 5 lbs Range 1 0 to 400 0 Watts RMS Resolution 0 1 Watts Electrical Accuracy 5 Reading or 3 Watts Power Supply External Universal Power whichever is greater Supply 12 VDC Output Voltage 83 to 264 VAC Current Frequency 47 to 63 Hz Range 30 to 2500 mA RMS Battery Sealed Lead Acid 6 VDC 7 2 AH Resolution 1mA Accuracy 2 5 Reading or 15 mA General whichever is greater Display LCD Graphical 256 x 64 Pixels with Backlight Limits Ventilation Internal Fan variable speed EE 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 Non Condensing Range 50 to 750 Q Connections Oscilloscope BNC Communications USB amp RS232 DB 9 External Loads 4mm Safety Sockets Resolution 50 0 Accuracy 1 DC Duty Cycle 50 1 minute period Auxiliary Test Load Fixed 200 Q Accuracy 1 DC Rating 225 Watts CQM Test Load Contact Quality Monitor test load is an independent variable load Range 1 to 500 Q Resolution 10 Accuracy 296 P Specifications are accurate as of
35. ating of only 175 watts These are just a few of the subtle differences between the new BC Biomedical ESU 2000 Series of ESU analyzers and competitive analyzers on the market today Don let the perceived promise of a particular brand fool you into making an inferior choice when it comes to selecting your new ESU analyzer Do your homework before you purchase Those Crazy amp Exotic Pulsed Waveforms Conmed and Erbe are 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 70 80 Figure 16 Figure 17 Conmed Spray RF Waveform Conmed Spray Pulsed Waveform Pulse Modes PULSE CUT PEAK Power is Displayed K 530 ms Fr 70 ms Power Setting PULSE COAG selected waveform AVG Power is Displayed Be Power Setting x2 ANNAR i IT tk tf 7 5 ms 5 ms Figure 18 Conmed Pulse Waveform Modes The BC Biomedical ESU 2050 Analyzer handles these pulsed waveforms easily and yields accurate results time after time leaving all competitive units behind wondering what hit them Copyright June 2007 by BC Group International Inc Author Michael R Erwine 15 Revision 1 June 13 2007 ESU 2300 External Load
36. ation of the electrosurgery generator waveform The ESU 2300 is a mid range analyzer similar in price point to the Fluke Biomedical RF 303gs but offers superior features and accuracy as result of the implementation of current sensing technology ESU 2400 More High End Technology to Come Is anything missing form the new BC Biomedical ESU 2000 Series lineup What about a high end analyzer The new BC Biomedical ESU 2400 high end ESU analyzer is currently under active development Stay tuned to BC Group International Inc for more to come on the new BC Biomedical ESU 2400 Common Element Patent Pending DFA Technology The common element of all instruments in our new ESU 2000 Series is our patent pending DFA Technology This technology platform allows the instrument to aggressively digitize the RF signal analyze its components and provide highly accurate results No other ESU analyzer on the market today uses this type of technology platform Not even the high end competitive instruments offer this advanced level capability Copyright June 2007 by BC Group International Inc Author Michael R Erwine 11 Revision 1 June 13 2007 In fact most competitive ESU analyzers on the market today utilize thermal technology where the ESU generator signal is fed into a thermal converter of some kind This component measures the waveform energy through a temperature change and provides a reading Most commercially availabl
37. cs Model 8920A Digital Wide Band True RMS Voltmeters currently in widespread use e Utilize external high precision 1 power resistors widely used in the OEM segment 7 The Fluke 8920A was discontinued at the end of 1999 due to product maturity and electronic component shortages For the detailed statement on product discontinuance from Fluke Electronics simply visit the following url http us fluke com usen support safetynote DiscontinuedProductNotice htm Copyright June 2007 by BC Group International Inc Author Michael R Erwine 9 Revision 1 June 13 2007 e Utilize external high accuracy current sensing transformers of 0 1 1 and 1 1 ratio typically Pearson Electronics Model 411 and 4100 transformers thus eliminating the virtual inaccuracies of commercially available analyzers that utilize voltage measurement techniques e Eliminate internal test load switching relays that add capacitive leakage at RF frequencies and decrease the overall level of instrument accuracy e Add the ability to capture and store in high resolution the ESU output waveform e Supply Crest Factor CF capability well in excess of the current industry competitive instrument limitation of 16 e Make the new instrument much smaller and lighter and more resistant to breakage during shipment than the current industry available ESU analyzers e n summary give us an instrument that we can use to test the way we have tested our electrosurgery generators o
38. dical ESU 2050 ESU analyzer was by design intended to provide a suitable replacement for the Fluke Electronics 8920A instruments currently in use by these manufacturers ESU 2050 Unprecedented 1 Accuracy In ESU Testing The accuracy specifications see ESU 2050 specifications on Page 21 of the new BC Biomedical ESU 2050 ESU analyzer are well beyond any competitive ESU analyzer of the market today meeting the requirements of even the most demanding electrosurgical manufacturers The ESU 2050 ESU analyzer allows the customer to test according to the exact same methodology as the electrosurgery generator manufacturers test their own products This is an industry first Now these manufacturers will be using the exact same instrumentation for test and measurement that typical electrosurgery generator customers do ESU 2300 A More Conventional 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 e Patent pending DFA Technology e Industry standard current sensing technology via a custom design current transformer designed specifically for the BC Biomedical ESU 2300 by Pearson Electronics e The latest in microprocessor design which allows for high speed digital acquisition and interrog
39. e active ESU analyzers have used this technique for many years The new BC Biomedical ESU 2000 Series of analyzers breaks this old technology trend and introduces an exciting new level of ESU measurement technology moving forward Up To 32 768 Data Points For advanced level users the number of A D converter samples used in displaying the electrosurgery generator measurement parameters can be adjusted to any of the following values 1024 2048 4096 8192 16 384 32 768 This setting adjusts the number of A D converter readings used in each RMS mV computation A higher setting requires more computation and is slower but results in a more stable reading This setting also determines the resolution of the stored and exported data sets for the captured electrosurgical generator waveforms The waveform data sets shown throughout this document and in Appendices E F and G all have 32 68 discrete data points ESU 2050 amp 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 2050 analyzer the proven Vishay Dale NH 250 series See Appendix J for additional information on these precision power resistors Figure 14 Vishay Da
40. e 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 new BC Biomedical ESU 2050 analyzer has been a totally different instrument as compared to the traditional approach to ESU testing Until now traditional ESU analyzers have had the following common elements e Internal load resistors typically the most fragile element of the conventional ESU analyzer e Accuracy on RMS power typically in the 5 to 10 range e Accuracy on RMS current typically in the 2 to 596 range e Crest factor the ratio of Vyeak to Vims limitation typically around 16 or less e Measurement technique typically less costly voltage measurement with the exception of the 454A which utilized electrosurgical manufacturer industry standard current sensing e Active type instruments typically utilize a thermal converter The new ESU 2050 is a direct result of extensive collaboration with leading medical device industry electrosurgery generator manufacturers The ESU 2050 analyzer was designed to be 100 compatible with the following mandates of some of the leading manufacturers in this area e Accuracy of 1 give us a calibration quality instrument that can replace the legacy Fluke Electroni
41. easurement Parameters That You Want The ESU 2300 offers multiple display screens for viewing instrument parameters and setup information See Figure 22 below for some examples of the wide screen layout of the ESU 2300 s LCD display with backlighting Copyright June 2007 by BC Group International Inc Author Michael R Erwine 17 Revision 1 June 13 2007 DISPLAY RECN HOLD SELECT SETUP Figure 22 ESU 2300 Multiple Options Are Available for Display of Measurement Parameteters Easy Setup and Operation The user interface of both the BC Biomedical ESU 2050 and ESU 2300 is extremely intuitive and easy to learn On screen selection of test loads and other setup parameters is extremely easy select Series SELECT LOCATION TO STORE Donut Atten 04 1 EE Location 1 Location 2 SELECTED RESISTANCE Location 3 SO0 0 2 S500 e j RETURM CANCEL SAVE STORE Figure 23 The ESU 2050 and ESU 2300 User Interface is Easy to Learn The learning curve for new users of the ESU 2050 and ESU 2300 ESU analyzers is short and both instruments have an extremely intuitive user interface ESU 2050 Graphical Mode 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 SELECT LOCATION TO S
42. el 454A Fluke Biomedical RF 303gs Originally marketed as the Bio Tek Instruments RF 303ns this is the current mid range ESU analyzer offering from Fluke Biomedical The RF 303rs does not utilize industry standard current sensing technology but uses simple voltage measurement instead This product was designed during the period of time that Lionheart Technologies owned and operated Bio Tek Instruments DNI Nevada and Dale Technology A concurrent companion product to the RF 303rs was originally introduced in 1998 under the DNI Nevada formerly Dynatech Nevada brand as the Model 402A The 402A was later re branded as the Dale Technology DALE3000 following the acquisition of the biomedical holdings of Lionheart Technologies by Fluke Electronics Fluke Biomedical in 1993 Instrument specifications for the Fluke Biomedical Bio Tek Instruments RF 303ns the DNI Nevada 402A and the Dale Technology DALE3000 are were essentially identical Current Fluke Biomedical advertised specifications for the RF 303ns are 5 of reading or 3 watts whichever is greater on RMS power and 2 5 of reading or 15ma whichever is greater on RMS current See Appendix B for full specifications on the RF 303ns DNI Nevada Model 402A The DNI Nevada Model 402A was the sister product to the Bio Tek Model RF 303 introduced concurrently with the RF 303 see information above under the RF 303ns Actual design development and manufacturing of the 402A and
43. enerator Testing the Generator Turning on the generator initiates an internal self test to verify the calibration and the operation of the speaker all indicators the displays and some internal components Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result To test the generator follow this procedure 1 Turn on the generator by pressing the front panel On switch Verify the following e All visual indicators and displays on the front panel illuminate e Activation tones sound to verify that the speaker is working properly 2 If the self test is successful a tone sounds Verify the following The macrobipolar and bipolar displays each show a power setting of one watt e The seal display shows one amber bar illuminated If the self test is not successful an alarm tone sounds A number may momentarily appear in the bipolar display and in most cases the generator shuts down Note the number and refer to Responding to System Alarms in Section 6 If you removed and or replaced the battery alarm number 105 may appear in the bipolar display when you turn on the generator If this happens calibrate the generator Confirming Outputs Use this procedure to ensure the accuracy of the generator Always confirm the output e After calibrating the generator or e Every six months Equipment e Valleylab smart connector adapter P N LS 0500 requ
44. ers introduces several distinct product attributes as compared to the industry standard current sensing technique Copyright June 2007 by BC Group International Inc Author Michael R Erwine 13 Revision 1 June 13 2007 e reduced manufacturing cost for the test equipment manufacturer e shorter product development time e reduced accuracy for the end user This is why we chose to utilize the industry standard current sensing methodology in our new BC Biomedical ESU 2050 and ESU 2300 instruments The manufacturers of these voltage measurement based ESU analyzers realize the shortcomings of this technology and simply try to explain around them The following statement is from a User s Manual Update for a competitive product that utilizes the voltage measurement technique RF303 Load Issues The load resistors typically used in ESU analyzers are not ideal they possess some reactive components that are frequency dependent The RF303 derives applied power by measuring the voltage across the set load and calculating the power NIR Most other ESU analyzers on the market derive the applied power by measuring the current flowing through a set load and calculating the power I R At fundamental frequencies below 500 kHz and regardless of the load setting the two methods of measurement are comparable Above 500 kHz and at the extremes of the loads the readings displayed by the two methods will differ on opposite sides of the expected value
45. facility and offices in Carson City NV The discontinuance of the DALE3000 was actually fairly close in time to the Fluke acquisition of Metron AS of Trondheim Norway which brought the Metron QA ES high end ESU analyzer to the Fluke Biomedical family of products BC Biomedical ESU 2000A The BC Biomedical ESU 2000A was originally introduced in the year 2000 based upon strong customer demand for a simple but effective legacy tester similar to the original Bio Tek Instruments RF 302 With accuracy of 2 of full scale on current and power the ESU 2000A remains popular with customers today It is still available from BC Group International Full instrument specifications for the ESU 2000A ESU analyzer can be found on the BC Group International web site at http testequipmentandtools com acatalog BCBiomedicalESU2000ADatasheet pdf Copyright June 2007 by BC Group International Inc Author Michael R Erwine 8 Revision 1 June 13 2007 Fluke Biomedical Metron QA ES The re branded Metron Trondheim Norway QA ES is the current high end ESU analyzer offering from Fluke Biomedical effective March 18 2007 Originally introduced by Metron AS in Trondheim Norway the QA ES offers accuracy of 2 of reading for RMS current measurements RMS power reading accuracy is not specified by the manufacturer The QA ES does not utilize industry standard current sensing technology See Appendix D for specifications on the Metron Q
46. her spend our time and effort designing and bringing new and innovative products such as the new ESU 2050 and ESU 2300 ESU Analyzers to market under the BC Biomedical brand than waste it re branding and re launching 5 to 10 year old technology base products Innovative new products are what we are all about not new photography and product overlays Well 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 will be recognized by our customers for what they are a sincere desire to lead the biomedical test and measurement industry through a continuous launch of exciting new products Our new BC Biomedical ESU 2050 and ESU 2300 ESU Analyzers are simply the most recent evidence of our real mission Stay tuned for much more to come 00 Vishay Dale NH 250 ze Precision Power Resisitor EET ET liecia LST 295g ege E i Pearson Electronics Current Transformer Figure 25 Typical Test Setup Using the ESU 2050 ESU Analyzer Test the Way ESU OEMs Test Their Products Copyright June 2007 by BC Group International Inc Author Michael R Erwine 20 Revision 1 June 13 2007 INPUT RANGE Voltage RMS Input Resolution Voltage Peak Resolution Frequency Accuracy ESU 2050 Product Specifications
47. hich was the introduction by Tyco Healthcare Valleylab in their Force FX Generator of Tissue Response Technology in the late 90 s This technology utilizes a constant feedback loop to the Tissue Resistance Computer Controlled OUTPUT Figure 11 Figure 12 Contact Quality Monitor CQM Function Tyco Healthcare Valleylab Tissue Response Technology Copyright June 2007 by BC Group International Inc Author Michael R Erwine 5 Revision 1 June 13 2007 generators microprocessor and actually adjusts the power level output of the generator in order to provide relatively constant power delivery and thus a consistent surgical effect at the surgical site regardless of tissue impedance Electrosurgery generator improvements continue with new introductions by leading manufacturers like Tyco Healthcare Valleylab Conmed Electrosurgery Division Erbe Bovie etc on a regular basis The need for routine testing and performance verification of these generators has not deceased due to these introductions of new technologies In fact there are more features and safeguards to test for proper operation on today s average electrosurgical generator than ever Some Common Electrosurgery Terminology Active Electrode an electrosurgical instrument or accessory that concentrates the high frequency current at the surgical site thus enabling the heating effect at the site and producing the desired electrosurgical effect Blend an electros
48. ifications Displayed parameters Power watts Power watts Power watts Power watts Power watts Peak Voltage RMS Current RMS Current RMS Current RMS Current RMS Voltage Test Load Q Peak to Peak Test Load Q Peak to Peak RMS Current Voltage Voltage Crest Factor Crest Factor Crest Factor Test Load Q Test Load Q 2 5 of Reading 2 5 of Reading 10 of Reading For a more thorough product comparison please visit www bcgroupintl com compare htm and download the product comparison sheet on the ESU 2000 Series in Adobe Acrobat PDF format 10 This is an abbreviated specification See the full specification in the product specifications at the end of this document or in the Appendices TT This is an abbreviated specification See the full specification in the product specifications at the end of this document or in the Appendices Copyright June 2007 by BC Group International Inc Author Michael R Erwine 19 Revision 1 June 13 2007 One Stop Source We Make It Easy for You BC Group International Inc does whatever it takes to make it easy on our customers Our customers who purchase the ESU 2050 won t have to go shopping elsewhere for their Pearson Electronics current sensing transformers or Vishay Dale NH 250 precision load resistors BC Group offers these product accessories directly to the customer without the standard long lead times from the original manufacturers Conclusion At BC Group International Inc we would rat
49. inpoint Coag Waveform Conmed System 5000 Pinpoint Coag Waveform Voltage mV Voltage mV D 5000 10000 15000 20000 25000 30000 35000 Sample 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 Utility Software Copyright June 2007 by BC Group International Inc Author Michael R Erwine 30 Revision 1 June 13 2007 APPENDIX G Continued Conmed System 5000 Output Waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export Conmed System 5000 Spray Coag Waveform Conmed System 5000 Spray Coag Waveform Voltage mV gt E ae e E o E gt 10000 15000 20000 25000 30000 35000 0 500 1000 1500 2000 2500 3000 Sample Sample 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
50. ired to confirm RF output e Valleylab bipolar forceps cord E0509 e Current transformer Pearson 411 e True RMS voltmeter such as the Fluke 8920 or equivalent e 10 100 200 500 and 1000 ohm 1 noninductive power resistors e Bipolar footswitch 6 12 LigaSure Vessel Sealing Generator Service Manual 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 89204 is no longer available and is being replaced with the BC Biomedical ESU 2050 Copyright June 2007 by BC Group International Inc Author Michael R Erwine AT Revision 1 June 13 2007 APPENDIX L Continued Valleylab Recommended Test Procedure Source Valleylab Force FX C Electrosurgical Generator Service Manual Periodic Safety Check 6 Press the Macro Macrobipolar button and repeat step A 7 Verify that the generator output for each mode is 315 24 mA rms If the output is outside the specified range calibrate the bipolar output as described in calibration steps 5 6 7 and 8 Then repeat this procedure If the output for one or more modes remains outside the specified range call the Valleylab Service Center Checking the Monopolar Output 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 sectio
51. ision 1 June 13 2007 ESU Testing 101 Some Testing History Electrosurgery generator technology has undergone tremendous technological advances over the past decade but the technology base of ESU analyzers has remained relatively slow moving over this same time period The recently discontinued Fluke Biomedical Model 454A dates back to around 1992 or 1993 and until now represents the culmination of research and development efforts on the behalf of competitive companies in the area of electrosurgery testing Here is a brief history of ESU testing devices over the past 15 to 20 years Analyzers are shown in the order of their introduction to the market Bio Tek Instruments RF 301 The very first offering in ESU analyzers by Bio Tek Instruments This No passive RF thermocouple ammeter type instrument got the job done There are still quite a few RF 301 instruments in use in the field today The design was basic and rugged Picture Available Neurodyne Dempsey Model 403A The Neurodyne Dempsey which later became Dynatech Nevada Inc Model 403A was a very small sized ESU tester with limited functionality This was a passive technology device with an RF thermocouple type analog ammeter and a single fixed 500 Q internal load Meter range was 0 2 A to 1 0 A 20 watts to 500 watts It was the company s first dedicated ESU tester There are very few of these units left in the market Bio Tek Instruments RF 302 The predecessor to
52. le NH 250 Precision Power Resistors Commonly Used With the ESU 2050 The BC Biomedical ESU 2300 ESU analyzer also uses 196 precision power resistors manufactured by Riedon Inc www riedon com These 225 watt rated precision resistors and are of a design that is more suitable for use as an internal component and have a superior accuracy specification compared to some of the resistors used in competitive ESU analyzers Product Development In Cooperation with ESU Manufacturers The product development campaign on the new BC Biomedical ESU 2050 analyzer and the subsequent design of the more conventional ESU 2300 analyzer has brought us into contact with some of the leading electrosurgical manufacturers in the world market Copyright June 2007 by BC Group International Inc Author Michael R Erwine 12 Revision 1 June 13 2007 tyco Falleylab ww ad M USA Incorporated SURGICAL SYSTEMS 9 CONMED Bovie Medical Corporation As we move forward with ongoing product support and possible enhancements to our ESU 2000 Series of ESU Analyzers we will remain in contact with these manufacturers Industry Standard Current Sensing Technology Virtually all of the world s leading electrosurgery generator manufacturers use RF current sensing as their standard means of measurement when they test service and calibrate their electrosurgical devices This is why we chose to implement the more costly but more effective current sensing
53. le and more condensed electronics technology came the introduction of the isolated output electrosurgical generator see Figure 10 below thus eliminating the concern over unwanted current division and vastly improving patient safety The outputs of these generators were no longer earth ground referenced so even the best electrical ground referenced contact made to the patient would not present the risk of high frequency burns at alternate sites CUT i COAG Low voltage High voltage waveform E waveform 100 duty e 696 duty cycle cycle Figure 7 Figure 8 Coagulation Waveform Tissue Penetration Cut vs Coag The shift in concern now focused on the quality of the patient return electrode and electrode site and over the succeeding years many manufacturers introduced new monitoring techniques designed 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 Figure 9 Figure 10 Ground Referenced Electrosurgical Generator Isolated Output Electrosurgical Generator In more recent years there has been a steady stream of advances in electrosurgery generator technology one of the most significant of w
54. n 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 monopolar footswitch to the Monopolar 1 Footswitch receptacle on the rear panel of the generator C Press the Pure button D Pressthe Cut up A or down V arrow buttons to set the cut power to 75 watts E Test the monopolar cut output 1 Press the footswitch cut pedal and while activating the generator note the output on the voltmeter 2 Release the footswitch pedal 3 Based on the voltmeter setting and the current transformer you are using calculate and record the output current F Press the Low cut button and repeat step 1 E G Press the Blend button and repeat step 1 E H Verify that the generator output for each mode is 499 38 mA rms Ifthe output is outside the specified range calibrate the monopolar output as described in calibration steps 5 6 7 and 8 Then repeat this procedure If the output for one or more cut modes remains outside the specified
55. n Range 30 to 2500 mA 1 mA Accuracy 2 596 of reading or 15 mA whichever is greater Bandwidth Measurement Circuitry Only Flat response 10 KHz to 10 MHz 3dB points 1 KHz to 20 MHz System Response Measurement Circuitry and Test Load Sections 3dB points 1 KHz to 10 MHz 300 Q Test Load Section Selections 15 Range 50 Q to 750 Q Step size 50 Q Signal Averaging Mode SAM 2 rolling average algorithms to smooth ESU output Display 4 digit red LED seven segments Front Panel Controls Measurement select 1 Watts or current Load select 2 Increment or decrement Top Panel Input Connections 7 Designations Generator output active 1 generator output dispersive 2 earth ground reference 2 auxiliary HF leakage load 2 Connector type 4 mm 160 diameter safety sockets IEC 1010 approved Serial Port Baud rate 2400 Fixed Connector type Male DB9 Safety Requirements U S A UL3101 1 Canada CAN CSA C22 2 No 1010 1 1992 International EN 61010 1 1990 73 23 EEC low voltage directive Electromagnetic Interference and Susceptibility 89 336 EEC Electromagnetic Amendment 93 68 EEC EN 50082 1 Group I EN 550221 Class A Environment Operating temperature 15 C to 35 C Storage temperature 0 C to 50 C Humidity lt 90 non condensing Case High impact plastic Dimensions 12 Lx135 Wx6 H 30 cm L x 34 cm W x 15cm H acy 4 of sel dval Weight Accurac
56. nce Charge Displayed e Power watts Parameters e HF Current milliamperes e Test Load ohms Tests Performed Generator Output e HF Leakage Performs HF leakage tests to IEC 601 2 2 1289 2 ANSI AAMI standards Type BF Test 1 Earth referenced monopolar output Type BF Test 2 Earth referenced monopolar output Type CF Bipolar Isolated monopolar or bipolar output Measurement e Technique Precision high voltage capacitive attenuator samples applied ESU signal This directly measured HF voltage and the selected test load resistance value utilized to derive the true RMS values of both current and wattage readings e HF Power watts Resolution 1 to 400 W Resolution 0 1 W RF303 Operator s Manual 1 3 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 27 Revision 1 June 13 2007 APPENDIX B Continued Fluke Biomedical RF 303gs Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Parameter Measurement cont d Bandwidth System Response Test Load Section 1 4 Specification Accuracy e Maximum power input 400 W RMS Accuracy 5 of reading or 3 watts whichever is greater e HF Current Range 30 to 2500 mA RMS Resolution 1 mA Accuracy 2 5 of reading or 15 mA whichever is greater e Bandwidth of RMS converter circuit 1 accuracy Flat response 10 KHz to 10 MHz 3 dB points 1 KHz to 20 MHz e System Respon
57. nnrennnnnseennnnnsnee 26 APPENDIX B Fluke Biomedical RF 303gs Instrument Specifications lsseeessssesssssssssssessseeeee nennen nennen nnns 27 APPENDIX C Dale Technology DALE3000 Instrument Gpecfcatons 31 APPENDIX D Metron QA ES Instrument Specifications nennen nennen nenne nnne nnn nnn nnns nnn nnns 33 APPENDIX E Valleylab ForceFX Generator Output waveforms cccccccceeseececceeccaeeeeeceeeeesseesseceeeeeesaeeeseeeeeeesessuaaseeeeeeeesaaaaeess 34 APPENDIX F Valleylab Force 2 Generator Output Waveiorms n0001nnnnennnennnrnnennennnrnnrennrrnrnnssnnrrrrensnnnrrrrnrrrnnsnnnrrrennsnnnnrneee 36 APPENDIX G Conmed System 5000 Output WaveformS nnne nennen nnn nnns n nnns naar nnns sss n aa nnns 38 APPENDIX H Pearson Electronics Model 411 Data heet 41 APPENDIX I Pearson Electronics Model 4100 Data Sheet n00nnnnn0nnnnnnnannnnnnnnnnnnrnnnnnsnnrnensrnrressnrnrnsnnrrrnnnnsnnrnnnnnrrnnnnnnrennnnnnen 42 APPENDIX J Vishay Dale NH 250 Data Gheei 43 APPENDIX K Sample Microsoft Excel Data EXPOR WOrkDOOK je 45 APPENDIX L Tyco Healthcare Valleylab Recommended Test bProcecdures 46 APPENDIX M ESU 2000 Series PC Utility Software Screen hotel 49 APPENDIX N History of BC Group International Inch 52 Copyright June 2007 by BC Group International Inc Author Michael R Erwine P Revision 1 June 13 2007 The Next Generation in ESU Testing is Finally Here With the introduction
58. o D 200 400 600 800 1000 1200 Sample Voltage mV Conmed System 5000 Blend 1 Cut Waveform Voltage mV 0 500 1000 1500 2000 2900 3000 3500 Sample Conmed System 5000 Blend 2 Cut Waveform Voltage mV D 500 1000 1500 2000 2500 3000 3500 Sample 5 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 Utility Software Copyright June 2007 by BC Group International Inc Author Michael R Erwine Revision 1 June 13 2007 APPENDIX G Continued Conmed System 5000 Output Waveforms Source BC Biomedical ESU 2000 Series PC Utility Software Excel File Export Conmed System 5000 Blend 3 Cut Waveform Conmed System 5000 Blend 3 Cut Waveform WENN VE H EE OC HN INS Voltage mV Voltage mV 0 5000 10000 15000 20000 25000 30000 35000 1500 2000 2500 3000 3500 4000 Sample Sample Conmed System 5000 Standard Coag Waveform Conmed System 5000 Standard Coag Waveform Voltage mV gt E bi E o gt 5000 15000 20000 25000 30000 35000 0 500 1000 1500 2000 2500 3000 Sample Sample Conmed System 5000 P
59. of the new BC Biomedical ESU 2000 Series of Electrosurgery ESU Analyzers the ESU 2050 and ESU 2300 instruments BC Group International Inc brings to market the most exciting and technologically significant advances in electrosurgical testing to come about in well over a decade The new BC Biomedical ESU 2050 represents an 18 month duration major product design effort in full cooperation with some of the leading electrosurgery generator manufacturers in the worldwide medical device market The ESU 2050 is the very first instrument of its kind to be introduced specifically designed for electrosurgery generator testing with 196 of reading accuracy and a testing methodology that is exactly the same as the one that many medical device manufacturers currently use The new ESU 2300 is a more conventional mid range ESU analyzer offering features and functionality above and beyond competitive analyzers in this mid range class Both analyzers can be easily upgraded in the field via the BC Biomedical Flash Update PC Utility Software in the event of a needed firmware update Together these new ESU analyzers from BC Group represent an unprecedented paradigm shift in electrosurgery testing technology and set a new baseline for the electrosurgery test device industry The long awaited next generation in ESU testing has finally arrived Electrosurgery 101 A Basic Review of Electrosurgery The following basic review on electrosurgery is derived f
60. 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 Software now you can export data sets to Microsoft Excel with up to 32 768 discrete data points on your electrosurgery generator s output energy waveform This export function automatically creates an Excel file that you can name anything you want No knowledge of Microsoft Excel is required The created Excel file will automatically include all of the measurement data as well as a graphical representation such as the one shown in Figure 19 below See Appendix K for a sample look at the Excel file structure Valleylab Force FX Desiccate Coag Waveform HH 800 600 400 20 eo e 20 Voltage mV eo 40 e 60 e 800 1000 0 5000 10000 15000 20000 25000 30000 35000 Sample Figure 19 Microsoft Excel Automatically Created Graphical Plot of Exported Electrosurgery Generator Waveform You can then use the power of Excel to analyze the data in any way you choose Once you export the data set to Excel you can manipulate this data set to accomplish specific tasks such as zooming in on a single cycle of a specific waveform See an example of this capability in the Figure 20 illustration below This is a user created Zoomed waveform based on the exported data Copyright June
61. r unmounted C RH 50 RH 100 and RH 250 size resistor unmounted D All types mounted to recommended aluminum heat sink RATED POWER IN Derating REDUCED HEAT SINK DERATING Derating is also required when recommended heat sink area is reduced A RH 5 and RH 10 size resistor B RH 25 size resistor C RH 50 RH 100 and RH 250 size resistor RATED POWER IN i i OF RECOMMENDED HEAT SINK AREA Heat Sink Derating www vishay com For technical questions contact ww2bresistors vishay com Document Number 30201 124 Revision 09 Sep 04 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 44 Revision 1 June 13 2007 APPENDIX K Sample Microsoft Excel Data Export Workbook Limited in format to what can be displayed on this page Date Time Sample OO OO JO Om P WN gt 4 3 2007 12 10 53 PM Voltage 6 24609375 3 123046875 5 205078125 0 7 287109375 2 08203125 2 08203125 3 123046875 6 24609375 4 1640625 9 369140625 3 123046875 5 205078125 3 123046875 4 1640625 7 287109375 2 08203125 1 041015625 6 24609375 1 041015625 5 205078125 2 08203125 6 24609375 3 123046875 2 08203125 10 41015625 2 08203125 4 1640625 8 328125 1 041015625 5 205078125 6 24609375 3 123046875 6 24609375 6 24609375 7 287109375 2 08203125 3 123046875 5 205078125 E Voltage mV SU 2050 Sampled Data 45 Valleyl The illustration abo
62. rom technical information obtained from various sources in the public sector including the Tyco Healthcare Valleylab document Electrosurgery Self Study Guide Copyright September 1999 Tyco Healthcare Valleylab This information is intended for basic review purposes of some of the terminology and basic 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 ll Wil High Current n Concentration HE 10 KHz we 00 kR Househo Muscle an Me A Jaiei im ut 1 LI z wire d r 1 oo k e 3 3 MHT D kHz Figure 1 Figure 2 Frequency Spectrum Showing Range Current Density Differences of Frequencies for Electrosurgery at Surgical Site vs Return Path Electrosurgery works based upon heat generated by the density see Figure 2 of the high frequency current being passed through human tissue At the surgical site the density is typically very high resulting in high heat and a cutting or coagulating effect The return path for the high frequency current is much larger and consequently much less current density exists at this area which allows the high frequency energy to safely leave the body without any adverse effects There are two basic modes of electrosurgery bipolar and monopolar Bipolar surgery see
63. rom the electrosurgical active electrode across an air gap to the tissue Ground Referenced Output an electrosurgical generator with an output that is electrically referenced to earth ground Isolated Output an electrosurgical generator with an output that is not electrically referenced to earth ground Leakage Current electrical current that flows along an undesired pathway usually to earth ground in an electrosurgical generator RF leakage current is high frequency current that regains its ground reference and seeks earth ground Patient Return Electrode an electrically conductive plate or pad also known as the dispersive electrode that recovers the high frequency current introduced into the patients body by the active electrode during electrosurgery This electrode minimizes the current density of this return current flow in order to minimize the possibility of high frequency burns at this electrode site Radio Frequency RF frequencies above 100 kHz that transmit radio signals the high frequency current utilized in electrosurgery Tissue Response Technology the Tyco Healthcare Valleylab electrosurgical generator technology that continuously measures the impedance resistance of the tissue in contact with the patient return electrode and automatically adjusts the output of the generator accordingly to achieve a consistent tissue effect Copyright June 2007 by BC Group International Inc Author Michael R Erwine 6 Rev
64. rosurgery is safer that monopolar electrosurgery and the subsequent risks of high frequency burns at the return electrode site are avoided Figure 3 Figure 4 Electrosurgery Bipolar Mode Electrosurgery Monopolar Mode Monopolar electrosurgery see Figure 4 is a more generalized and more frequently used mode Monopolar electrosurgery utilizes higher voltage levels than bipolar resulting in higher power delivered at the surgical site The need for a well prepared and maintained patient electrode site is of paramount concern in monopolar electrosurgical applications in order to prevent high frequency burns at the patient return electrode site The high frequency waveform produced by the electrosurgical generator determines the physiological effect of the application of this energy to the tissue in the body The Cut mode of an electrosurgical generator creates a continuous waveform as shown in Figure 5 Different degrees of hemostasis coagulation can be achieved by utilizing varying degrees of Blended waveforms as shown in Figure 6 PURE CUT BLEND 1 BLEND 2 BLEND 3 100 on 50 on 40 on 25 on 50 off 60 off 75 off 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 cool
65. s down between spikes producing coagulation of the cells Fulguration is achieved in the Coag mode of the electrosurgical generator with the tip of the surgical active electrode held above but not in contact with the tissue Electrosurgical Desiccation is achieved in either the Cut or Coag modes of the generator The difference between Desiccation and Fulguration is the tip of the active electrode must contact the tissue as in Figure 8 in order to achieve Desiccation The more desired mode to achieve tissue Desiccation through direct tissue contact is the Cut mode Older electrosurgical generators those produced prior to around 1968 are generally ground referenced devices and must be used with extreme care to avoid unwanted current division and possible resulting high frequency burns at this site or at multiple sites This is illustrated in Figure 9 below Current division can occur at any point of contact with an earth grounded point such as the frame of the surgical table or the outer chassis of another medical device For the most part these types of devices are no longer used in surgical procedures mainly due to advances in electrosurgical generator technology and concerns over safety Copyright June 2007 by BC Group International Inc Author Michael R Erwine 4 Revision 1 June 13 2007 Advances in electrosurgery generator technology brought about the solid state generator around 1968 Along with this more reliab
66. se measurement circuitry and selected test load 3 dB points 1 KHz to 10 MHz 9 300 ohms e Main Test Load Selections 15 Selection range 50 to 750 Q Step size 50 Q Duty cycle 50 400 W maximum 30 seconds ON during any one minute period Resonance impedance variation 0 5 dB maximum 10 MHz Specifications Copyright June 2007 by BC Group International Inc Author Michael R Erwine 28 Revision 1 June 13 2007 APPENDIX B Continued Fluke Biomedical RF 303gs Instrument Specifications Source Fluke Biomedical RF 303 Operator s Manual Parameter Test Load Section cont d Battery Auxiliary Contact Quality Monitor Testing Feature Display Specification Accuracy e Main Test Load cont d e Accuracy DC to 500 KHz 4 of selected value measured at calibration to 1 across the entire operating temperature range e Auxiliary Leakage Test Load Fixed 200 Q Accuracy 4 Power rating 225 W e Input Capacitance nominal Active to Dispersive 30 pF Active or Dispersive to Earth ground 40 pF e Type Sealed lead acid e Voltage 12 volts nominal e Capacity 2 2 AH e Field serviceable No e Typical time between recharges 2 hour e Battery cycles 200 e Recharging Instrument has internal automatic charger No external charger required The main test load section is used to perform a simple Auxiliary Contact Quality Monitor Testing Feature COM operational check e
67. stems Burnaby Canada Lionheart Technologies Inc Carson City NV DNI Nevada Inc Carson City NV Bio Tek Instruments Corp Burlington VT Ultramedic Ltd Liverpool England Labatoire Gamida Eaubonne France Dale Technology Inc Thornwood NY Fluke Biomedical Corp Carson City NV Fluke Electronics Corp Everett WA Metron USA Grand Rapids MI During his career track Mr Erwine has served in the following capacities just to name a few Product Manager Project Manager Product Validation Engineer Commercial Manager National Sales Manager International Sales Manager Strategic Accounts Manager VP of Sales amp 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 Model 454A ESU Analyzer Following the acquisition of Dynatech Nevada Inc by Lionheart Technologies in 1997 Mr Erwine launched the DNI Nevada Model 402A ESU Analyzer and assisted the Bio Tek Instruments sales and marketing staff in the launch of their very first active ESU testing device in the way of the concurrent Bio Tek Model RF 303 currently offered as the Fluke Biomedical RF 303ps Mr Erwine has worked heavily with Tyco Healthcare Valleylab and Conmed Elec
68. the Bio Tek RF 303 the RF 302 was a passive RF thermocouple ammeter type instrument This gave an advantage to the RF 302 above other competitive 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 generator testing GEES aq stil I Dynatech Nevada Model 443 The Dynatech Nevada Model 443 was the company s very first active type design in ESU analyzers Despite it s active internal circuitry and measurement technology the Model 443 still utilized an analog meter The Model 443 was discontinued shortly after the introduction of the Model 453A Dynatech Nevada Model 453A The predecessor to the 454A the Dynatech Nevada Model 453A was probably the very first Hi Tech ESU analyzer on the market t utilized active technology Introduced in the mid 1980 s the Model 453A was in production until the introduction of the Dynatech Nevada Model 454A starting in 1992 or 1993 The 453A had a small LED 7 segment display and was a fairly large instrument weighing well over 15 pounds There are still many 453A ESU analyzers in use in biomedical departments across the U S today P
69. 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 RF 303 was given a battery for portable operation Slightly different enclosures were also chosen and the 402A was given an LED 7 segment display while the RF 303 was given an LCD 7 segment display The instrument firmware that operated the 402A and RF 303 was common between the products with firmware subroutines that recognized which instrument was being operated by the microprocessor The RS232 communications port was added to the RF 303 much later in time following the discontinuance of the 402A When Fluke Electronics Fluke Biomedical acquired the biomedical holdings of Lionheart Technologies in 1993 the DNI Nevada Model 402A was soon after discontinued and re branded under the Dale Technology brand as the DALE3000 Dale Technology DALE3000 The DALE3000 existed in the market for less than three years before it was discontinued The re branding of the DNI Nevada Model 402A to the Dale Technology DALE3000 was concurrent with the relocation of the Dale Technology business from its original location in Thornwood NY to Carson City NV in the then existing Fluke Biomedical manufacturing facilities the original Dynatech Nevada manufacturing
70. trosurgery Division since January 2006 on the development and functionality of the new BC Biomedical ESU 2050 analyzer and has also interfaced with Erbe USA Bovie Megadyne and others during the BC Biomedical ESU 2000 Series development project Mr Erwine continues to work with all of these medical device manufacturers in his various roles at BC Group International Inc The design and functionality of the new BC Biomedical ESU 2000 Series of ESU Analyzers is strongly rooted in these collaborative efforts with some of the same medical device manufacturers with whom Mr Erwine has historically worked If you have questions concerning anything in this document or on the ESU 2000 Series of Electrosurgery Analyzers in general please feel free to e mail the author at merwine bcgroupintl com Copyright June 2007 by BC Group International Inc Author Michael R Erwine 24 Revision 1 June 13 2007 APPENDICES All documents and information contained in the following Appendices have been obtained from 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 companies Copyright June 2007 by BC Group International
71. trosurgical unit ESU testing needs The DALE3000 makes it easy to conduct generator output HF leakage and COM tests allowing you to read the results on a bright LED display Compatible with both isolated and earth referenced ESUs the DALE3000 has fifteen standard test loads to match the requirements of most ESUs All ofthe high frequency HF leakage tests as specified in the current IEC and ANSI AAMI standards are easily conducted The DALE3000 will also verify the basic operation of the dispersive electrode s Contact Quality Monitor COM Features e Easy to use test instrument e Performs output HF leakage amp COM tests e Select watts current and test load with a touch of a button e Main test loads from 50 Q to 750 Q in 50 Q steps e Performs all IEC amp ANSI AAMI HF leakage tests e Auxiliary HF leakage test load e Large LED 4 digit numeric display e Oscilloscope output e RS232 serial port interface for test automation Since the instrument s enclosure is constructed of high grade plastic the DALE3000 is lighter than other models DALE3000 Also you are protected from potentially dangerous electrical shock while testing the high voltage high frequency ESU generator output Standard Accessories Test leads 4 Active dispersive earth reference COM Two insulated jumpers Fuses Two 3 15 A Detachable power cord set Operating manual Optional Accessories Serial cables Hard sided c
72. urgical generator output waveform that combines the features of cut and coag waveforms cutting with various degrees of hemostasis coagulation Contact Quality Monitor CQM a system that constantly monitors the impedance of the physical connection between the patients body and the patient return electrode and interrupts power form the electrosurgical generator is the quality of this connection is compromised electrically Current Density the amount of electrical current flow per unit of surface area as current density increases so does the heating of the tissue in the immediate location Current Division high frequency electrical current leaving the intended electrosurgical patient circuit and following an alternate low impedance path of lesser resistance 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 continuous waveform optimized for tissue cutting Desiccation the effect of tissue dehydration and protein denaturation caused by direct contact between the electrosurgical active electrode and the tissue Fulguration using electrical arcs sparks to coagulate tissue whereby the sparks jump f
73. ustries the company that engineered and manufactured most of BC Biomedical brand products purchased BC Group This acquisition has allowed our products and services to expand at an even faster pace BC Group under the BC Biomedical brand is now the second largest manufacturer of biomedical test and measurement equipment in the world 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 products for the biomedical engineering community For 2007 our new ESU 2000 Family of Electrosurgery Analyzers and our new ULT 2000 Series of Ultrasound Electrical Leakage Current Testers are just the latest evidence of this important collaboration with medical device manufacturers worldwide We have a lot more in store for the future so keep checking our website for the latest additions to the BC Biomedical product line e pene a e Be sr a i E F ry L d TT FL AES MAT Ach T TB H jaa a 114 dpn poop d a LE kA LI 1 iat kriss T T YOUR ONE STOP BIOMED SHOP Website www bcaroupintl com E mail merwine bcgroupintl com Copyright June 2007 by BC
74. ve shows the 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 measurement data Excel file size is approximately 1 5 MB Copyright June 2007 by BC Group International Inc Author Michael R Erwine Revision 1 June 13 2007 APPENDIX L Valleylab Recommended Test Procedure Source Valleylab Force 2 Electrosurgical Generator Service Manual Recommended Test Equipment Recommended Test Equipment You will need the following equipment to perform the checks and calibration described in this section If you use substitute equipment it must meet or exceed the specifications of the recommended equipment Tektronix type 465 Oscilloscope or equivalent with 50 MHz or greater band width Tektronix type P6015A High Voltage Probe e Tektronix type P6009 100X Probe Simpson Model 1339 RMS RF Ammeter 0 250 mA e Wattmeter 0 500 W 300 ohm load and 100 ohm load with reactive phase angle of less than 20 degrees at 500 kHz e Variable Resistor 0 to 150 ohms e Fluke Model 8920A True RMS Meter Pearson Model 411 Wideband Current Transformer Dale NH250 1 Noninductive Load Resistors Line
75. ver 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 and functionality in a commercially available ESU analyzer Testing with the new ESU 2050 analyzer is remarkable easy and requires minimal setup as can be seen in Figure 13 below Vishay Dale NH 250 Precision Power Resisitor Pearson Electronics Current Transformer Figure 13 Typical Test Setup Using the ESU 2050 ESU Analyzer Test the Way ESU OEMs Test Their Products See complete product specifications for the ESU 2050 on Page 21 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 10 Revision 1 June 13 2007 ESU 2050 A Replacement for the Discontinued Fluke 8920A Instrument The Fluke Electronics Model 8920A Digital Wide Band True RMS Voltmeter with BNC CH Input was widely adopted by electrosurgical generator manufacturers around the world P ce Fluke Electronics discontinued this instrument and ceased all shipments by the end of NT 1999 leaving a void in the industry Since the formal discontinuance of the 8920A several electrosurgical generator manufacturers have searched for a_ suitable replacement instrument capable of delivering the same functionality and at the same level of accuracy as the 8920A But none had been found up to and including the beginning of 2007 The development of the new BC Biome
76. y 4 of selected value Modes Simplex and duplex 12 Ibs 5 5 kg Maximum duty cycle 400 W 50 period one minute Oscilloscope Output Uncalibrated 70 Transformer coupled output connector Auxiliary Leakage Test Load type BNC Fixed 200 Q Accuracy 4 rated 225 W Ventilation Variable Speed Fan Input BEE SE at 300 Q Over temperature protection Active to neutral 30 pF Blocked rotor optical sensor detector Active or neutral to earth Power Requirements ground 40 pF Operating voltage frequency 115 230 VAC 50 Hz 60 Hz Auxiliary Contact Quality Monitor CQM Test Maximum input 60 W nee uses 3 15 A 2 user The main test loads are used to perform Tues i ium i replaceable externa a simple operational check of the P l ESU s COM feature HF SURGICAL EQUIPMENT CONNECT ONE HF LEAD ONLY rg D sen sont QE Rc Measuring Resistance Measuring Rated tez load Resistance 200 TYPE CF Load between electrodes Generator output Isolated bipolar output 1 800 544 3253 e www daletech com 15 Copyright June 2007 by BC Group International Inc Author Michael R Erwine 32 Revision 1 June 13 2007 APPENDIX D Metron QA ES Instrument Specifications Source Metron QA ES Product Data Sheet QA ES MKII Specifications ESU TESTING ansur QA ES OFFERS THE GENERAL INFORMATION FOLLOWING FEATURES GENERATOR OUTPUT CONTINUOUS OPERATION continuous REMOTE CONTROL measurement of Power Current

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