Ethicon Generator G11 Service Manual

Ethicon Generator G11 Service Manual

Hide thumbs Also See for Generator G11:
Table of Contents

Advertisement

Generator G11
Service Manual
V 1.0

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Generator G11 and is the answer not in the manual?

Questions and answers

Summary of Contents for Ethicon Generator G11

  • Page 1 Generator G11 Service Manual V 1.0...
  • Page 2: Table Of Contents

    PowerModuleDisassemblyProcedure � ��������������������������������������������������������������������������������������������������������������������15 SpeakerRemovalProcedure�������������������������������������������������������������������������������������������������������������������������������������16 Connector/DeviceReceptacleRemovalProcedure � ������������������������������������������������������������������������������������������������17 FrontPanelDisassemblyProcedure � �������������������������������������������������������������������������������������������������������������������������18 FootswitchReceptacleRemovalProcedure � �������������������������������������������������������������������������������������������������������������20 HeatSinkFanRemovalProcedure���������������������������������������������������������������������������������������������������������������������������20 PowerCordReceptacleRemovalProcedure������������������������������������������������������������������������������������������������������������21  � ������������������������������������������������������������������������������������������������������������������������������������22 Chapter 4 - Generator G11 Functional Test DeviceDescription � ���������������������������������������������������������������������������������������������������������������������������������������������������22 ToVerifytheEnergyOutputoftheGeneratorG11��������������������������������������������������������������������������������������������������22 OutputDriveSpecifications��������������������������������������������������������������������������������������������������������������������������������������23 OutputVerificationProcedure � ����������������������������������������������������������������������������������������������������������������������������������24 FinalInspection���������������������������������������������������������������������������������������������������������������������������������������������������������29 GeneratorG11FunctionalTestResults � ��������������������������������������������������������������������������������������������������������������������29 ��������������������������������������������������������������������������������������������������������������������30 Chapter 5 - Assembly Diagram and Spare Parts List MainAssemblyDiagram �...
  • Page 3: Overview

    Generator G11 Service Manual Overview Please read all information carefully. Go to www.e-ifu.com for the latest version of this manual. Failuretoproperlyfollowtheinstructionsmayleadtoserioussurgicalconsequences� Important: ThismanualisdesignedtoprovideserviceandrepairinstructionsfortheGeneratorG11�Itisnotareferencetosurgicaltechniques� Harmonic andEnSeal aretrademarksofEthiconEndo-Surgery� ® ® Scope ThisServiceManualcontainsoperationalanddiagnosticinformation,repairandreplacementproceduresandfunctionaltestinformation, whichhasbeendesignedtoassisttheServiceRepresentativeintheisolationandrepairoffaultsaswellasmaintenanceoftheEthicon Endo-SurgeryGeneratorG11�Thisdocumentationassumesthattheservicerepresentativeisfamiliarwiththeelectricalandmechanical standardsapplicabletomedicaldevices�Thisdocumentationalsoassumesthattheservicerepresentativeisfamiliarwiththeuseofanyspecial toolsthatarerequiredtoservicetheGeneratorG11� Standard Conventions Used The Use of Caution, Warning, and Note Statements InformationrelativetothecompletionofataskinasafeandthoroughmannerwillbesuppliedintheformofaCaution,aWarning,oraNote statement�Thesestatementsarefoundthroughoutthedocumentation�...
  • Page 4: HowSupplied

    Generator G11 Service Manual How Supplied TheGeneratorG11issuppliedinasemi-ready-to-usestate�TheshippingboxcontainstheGeneratorG11,powercordandoperator’smanual� ThedisposableEthiconEndo-SurgeryEnSealorHarmonicinstrumentsarenotincludedinthispackagingandmustbepurchasedseparately� TheHarmonicdeviceconnector(HGA11),EnSealdeviceconnector(EGA11),footswitch(FSW11),cart(CRT11)andverificationkey (GEN11VK)arealsoavailableseparately� Illustration and Nomenclature Front Panel of the Generator Figure 1 POWERON/OFF Glowsgreenwhenthegeneratorispoweredup� SWITCH DISPLAY/ Displayssysteminformationandservesasinterfaceforadjustingcontrolsandsettings� TOUCHSCREEN CONNECTOR/ Receptacleusedtoattachtheconnectorsordevicestothegenerator� DEVICE RECEPTACLE Back Panel of the Generator Figure 2 POWERCORD Receptacleusedtoattachthepowercordtothegenerator� RECEPTACLE  GeneratorG11,V1�0...
  • Page 5: GeneralWarnings

    Generator G11 Service Manual FOOTSWITCH Receptacleusedtoconnectthefootswitchtothegenerator� RECEPTACLE POTENTIAL Providesmeansforconnectiontoapotentialequalizationconductor� EQUALIZATION TERMINAL Footswitch Figure 3 MIN(LEFTPEDAL) ActivatespowerforEnSealorminimumpowerforHarmonic� MAX(RIGHTPEDAL) ActivatesmaximumpowerforHarmonic� General Warnings • Readinstructionspriortoenergyactivation,anduseproperelectricalsafetyandhospitalprocedureswhenworkingonthegeneratorunit� Servicingshouldbeperformedbyqualifiedpersonnelonly� • Alwaysdisconnectthedevicefromtheelectricalpowersourcebeforeservicing� • Afterremovingthecover,inspecttheinternalcomponentsforobviousdamageorforeigndebris�Neverremoveorinstallanypartswith thepoweron� • Verifythattheunitisfullyoperationalpriortoadministeringpoweroutput� • Highvoltagesmaybepresentonsurfacesinsidethegenerator�Nevertouchanexposedconductivesurfacewhilethecoverisremoved andtheunitisenergized� • Thisequipmentisforuseonlybyqualifiedmedicalpersonneltrainedintheuseofultrasonicsurgeryorelectrosurgery�Inappropriateuse oftheequipmentbyuntrainedmedicalpersonnelmayresultinhazardouselectricaloutput� • TheGeneratorG11containscomponentsthataresensitivetoelectrostaticdischarge(ESD)�ProperESDprecautionsmustbetakenwhile servicingtheGeneratorG11�Repairworkmustbedoneatastaticcontrolledworkstation�Useanantistaticcontainerforthetransportof ESDsensitivecircuitboardsandcomponents�...
  • Page 6: GeneralCautions

    Generator G11 Service Manual medicalequipmentsuchasmonitorsandimagingsystems� • Activationwithaccessoriesandcablesotherthanthosespecifiedmayresultinunpredictableperformance,increasedelectromagnetic emissions,ordecreasedelectromagneticimmunity�Nocustomermodificationofthisequipmentisallowed;modificationofthis equipmentcouldhaveanegativeimpactonelectricalsafetyandelectromagneticemissions� • Toavoidtheriskofelectricshock,thisequipmentmustonlybeconnectedtoasupplymainwithprotectiveearth� • ToisolatetheGeneratorG11fromsupplymainspower,disconnectthepowercordeitherfromthebackpanelofthegeneratororfromthe wall�Ensureaccesstothesepointsarekeptclear� General Cautions • Thetouchscreendisplayofthegeneratorisverysensitive�Donotusesharpmetalobjectsonthetouchscreen� • Duringservicing,whenthebottomscrewsareremovedandthedeviceisopenexercisepropercautionasahazardousconditionmayexist� • Replacefusesonlywiththeappropriatetypeandrating�SeeSystem Specifications� • DonotsterilizetheGeneratorG11�Sterilizationwilldamagetheunit� • DonotrestricttheopeningsonthebottomandthebackpaneloftheGeneratorG11,astheyprovidetherequiredairflowforcooling� • Ifelectromagneticinterferencewithotherequipmentissuspected,reorientthedeviceorremovepossiblesourcesofinterference(for example,cellularphones,radios,etc�)fromtheroom� • Activationofaradiofrequencydevicewhennotinapositiontotestenergyactivationmaycausecapacitivecoupling� • UseoftheCart(CRT11)isrecommendedifGeneratorG11ismovedoutoftheoperatingroom�Maintaincontrolofthegeneratorandcart whenmovingoverthresholds� • DonotreplaceboththemainPCBandBezelPCBsimultaneously�Doingthiswillcompromiseinternalelectronicinformationstored withinthegenerator�Replaceoneboardandpower-uptheunitpriortoremovaloftheotherboard� Maintenance and Repair PeriodiccalibrationisnotrequiredforGeneratorG11�PeriodiccheckofoutputusingGEN11VKisrecommendedperfacilityguidelines�...
  • Page 7: GeneratorG11FunctionalityOverview

    Generator G11 Service Manual and/orsoldbythematanytimewithoutincurringanyobligationtomakethesameorsimilarchangesonproductspreviouslybuiltand/orsold bythem� Customer Service ContacttheEthiconEndo-SurgeryCustomerServiceDepartmentoryourlocalrepresentativeforanycustomerortechnicalsupport� Call1-800-USE-ENDO(1-800-873-3636)intheU�S�only� Chapter 2 - Theory of Operation Generator G11 Functionality Overview TheHarmonicandEnSealinstrumentsthatconnecttothegeneratoraresurgicaldevicesthatcombinehighcompressionandlowheatto quicklycreatestrongvesselsealswhilegeneratingminimalsmoke,tissuechar,orthermalinjury� Generator G11 Theory of Operation TheGEN11generatorisaflexible,high-power,widebandelectricalsurgicalinstrumentpowersource�Themaincomponentofthesystem isapush-pullpoweramplifierthatdrivesanoutputtransformer�Theoutputtransformeriscapableofsteppinguptheoutputvoltageofthe amplifiertoamaximumof420Vrms@0�75ArmsforHarmonicinstruments,or,viaanintermediatetaponthesecondarycoil,100Vrms @3�0ArmsforRFinstruments�Differentinstrumentswillutilizedifferentrangesofthegenerator’soutput�Therefore,dependingonthe particularinstrumentused,themaximumoutputofthegeneratormaynotbeachievedduringinstrumentactivation�Theoutputtransformer alsoprovidesthenecessaryisolationfromearthground(perIEC60601-1)oftheoutputsthatcanpotentiallycomeincontactwithpatients� ThereareDC-blockingcapacitorsinserieswiththeRFoutput,asrequiredbymedicalregulationIEC60601-2-2� Theinputtotheamplifierisfedbyahigh-speeddigital-to-analogconverter(DAC)thatisinturncontrolledbyadigitalsignalprocessor(DSP) throughafield-programmablegatearray(FPGA)�TheDSPdigitallycontrolsthewaveshape,amplitude,andfrequencyoftheoutputsignal inclosed-loopfashionbymonitoringtheoutputvoltageandcurrentthroughtwohighspeedanalog-to-digitalconverters(ADC)�Theoutput voltageandcurrentarefedtotheADCthroughisolationtransformersthatcrossthepatient-isolationbarrier�Thewaveshapeisgeneratedby theDSPusingdirectdigitalsynthesiswithintheFPGA�Theamplitudeiscontrolledonafinescaledirectlythroughthehigh-speedDAC,and onacoarsescalethroughalower-speedDACwhichsetsthefull-scalerangeofthehigh-speedDAC�...
  • Page 8: MainPcbI/ODiagram

    Generator G11 Service Manual Main PCB I/O Diagram POWER SUPPLY AC LINE SYSTEM VOLTAGES POWER SUPPLY ENABLE SWITCH-MODE CONVERTER BIAS PATIENT ISOLATED CIRCUITS MEMORY DSP PROCESSOR FPGA SIGNAL COND. SERIAL CKT. I/O PORT FPGA POWER SUPPLY ENABLE MEMORY ON / OFF...
  • Page 9: BottomCoverAndEpacRemovalProcedure

    Generator G11 Service Manual Chapter 3 - Repair and Replacement Procedures Bottom Cover and EPAC Removal Procedure 1� Turntheunitupsidedown� Figure 5 2� Removethefourmountingscrewsasshownintheimage� Note: Duringdisassemblyandassembly,metalshavingsmaybegeneratedwhenscrewingandunscrewingscrews�Besuretocleanup anymetalshavings� Figure 6 3� Removethebottomenclosurebyslidingitbackwards� Figure 7  GeneratorG11,V1�0 2011-04...
  • Page 10: MainPcbDisassemblyProcedure

    Generator G11 Service Manual 4� SeparatethebottomEPAC� Figure 8 Main PCB Disassembly Procedure Note: ThemainPCBcontainsinformationthatiselectronicallystored�OnceanewPCBhasbeeninstalledinthegeneratorand poweredup,itcannotbeusedinanothergenerator�PleasebesureyouwanttoreplacethePCBbeforeinstallingthenewone� Caution: DonotreplaceboththemainPCBandBezelPCBsimultaneously�Doingthiswillcompromiseinternalelectronicinformation storedwithinthegenerator�Replaceoneboardandpower-uptheunitpriortoremovaloftheotherboard� 1� DisconnecttheJ4DCConnectorandPowerGroundingCableasshown� Figure 9 Figure 9a  GeneratorG11,V1�0 2011-04...
  • Page 11 Generator G11 Service Manual Figure 9b Figure 9c 2� Disconnectthefollowingasshownintheimages:  - J5Footswitch Figure 10  GeneratorG11,V1�0 2011-04...
  • Page 12 Generator G11 Service Manual Figure 10a  - J8EnclosureFan Figure 11 Figure 11a  GeneratorG11,V1�0 2011-04...
  • Page 13 Generator G11 Service Manual 3� SeparatethePCBfromthegenerator� Figure 12 4� Removethefollowingelectricalconnectionsandroutewires:  - J21PowerSupplyIO Figure 13  - J23Speaker Figure 14  GeneratorG11,V1�0 2011-04...
  • Page 14 Generator G11 Service Manual  - J27HeatsinkFan Figure 15  - J25Backlight Figure 16  - J28Receptacle9pin Figure 17  GeneratorG11,V1�0 2011-04...
  • Page 15 Generator G11 Service Manual  - J24Receptacle5pin Figure 18  - J29LCDFlatConnector Figure 19 Figure 19a  GeneratorG11,V1�0 2011-04...
  • Page 16 Generator G11 Service Manual Figure 19b  - J30BezelFlatConnector Figure 20 Figure 20a  GeneratorG11,V1�0 2011-04...
  • Page 17 Generator G11 Service Manual Figure 20b Power Module Disassembly Procedure 1� Removethepowermodulegroundconnectorfromthemoduleterminal� Figure 21 2� Takeoutthepowermodulefromtheunit� Figure 22  GeneratorG11,V1�0 2011-04...
  • Page 18 Generator G11 Service Manual Speaker Removal Procedure 1� RemovethetopEPACfromthetopchassis� Figure 23 Figure 23a Figure 23b  GeneratorG11,V1�0 2011-04...
  • Page 19 Generator G11 Service Manual 2� Pulloutthespeakerusingflatheadscrewdriver� Note: Thespeakerisstucktothetopwithtape�Itisseparatedusingaflatheadscrewdriver� Figure 24 Connector / Device Receptacle Removal Procedure 1� RemovethesidescrewsoftheConnector/DeviceReceptaclewithaT15Torx� Note: Duringdisassemblyandassembly,metalshavingsmaybegeneratedwhenscrewingandunscrewingscrews�Besuretocleanup anymetalshavings� Figure 25 2� SeparatetheConnector/DeviceReceptaclefromthetopchassis� Figure 26  GeneratorG11,V1�0 2011-04...
  • Page 20 Generator G11 Service Manual Front Panel Disassembly Procedure 1� Removethetwoscrewsfromthetopchassis� Note: Duringdisassemblyandassembly,metalshavingsmaybegeneratedwhenscrewingandunscrewingscrews�Besuretocleanup anymetalshavings� Figure 27 2� SeparatetheBezelassemblyfromthetopenclosureandLCDcablesasshownbelow� Figure 28 3� RemovegasketandLCDfromtheBezel� Figure 29  GeneratorG11,V1�0 2011-04...
  • Page 21 Generator G11 Service Manual Figure 29a 4� SeparatetheLCDgasketfromtheBezel� Figure 30 5� DisconnecttheBezelPCBcables� Note: TheBezelPCBcontainsinformationthatiselectronicallystored�OnceanewBezelPCBhasbeeninstalledinthegeneratorand poweredup,itcannotbeusedinanothergenerator�PleasebesureyouwanttoreplacetheBezelPCBbeforeinstallingthenewone� Caution: DonotreplaceboththemainPCBandBezelPCBsimultaneously�Doingthiswillcompromiseinternalelectronicinformation storedwithinthegenerator�Replaceoneboardandpower-uptheunitpriortoremovaloftheotherboard� Figure 31  GeneratorG11,V1�0 2011-04...
  • Page 22 Generator G11 Service Manual 6� TakeoutthePCBfromtheBezel� Figure 32 Footswitch Receptacle Removal Procedure 1� Loosenthenutandseparatethefootswitchreceptaclefromthebackpanel� Figure 33 Heat Sink Fan Removal Procedure 1� SeparatetheheatsinkfanandthemainboardfanfromtheEPACslots� Figure 34  GeneratorG11,V1�0 2011-04...
  • Page 23 Generator G11 Service Manual Power Cord Receptacle Removal Procedure 1� Removethesidescrewsandseparatethepowercordreceptaclefromthebackpanel� Figure 35 2� Removethesetscrewandwasheronthepowerentryringterminal� Note: PowerEntryModuletotheChassisGroundmustgoontopofawasherandthenbeimmediatelybackedupbyanutwithcaptive washer�Thisistheprotectiveearthgroundandthisconfigurationisregulated�Theremainingtwoterminalscangoonineither orderandthentheymustbebackedupwiththenutwithcaptivewasher� Figure 36  GeneratorG11,V1�0 2011-04...
  • Page 24: Device Description

    Note: RefertoTable1forresistorvaluesrequiredfortheoutputverification,ifnotavailablewithintheElectrosurgicalanalyzer,these resistorsneedtobeconnectedtotheauxiliaryconnectionoftheElectrosurgicalanalyzer: Table 1 – Required Resistor Values for Output Verification Load Resistor Value Minimum Load Resistor Power Rating (Ohms) (Watts) 1250 To Verify the Energy Output of the Generator G11 TheOutputVerificationfunctionoftheGEN11VKverifiesthatHarmonicorEnSealpoweroutputsarewithinrequiredspecificationsforthe GeneratorG11�InHarmonicmode,performoutputverificationbydrivingtwopredeterminedoutputcurrent-drivelevelsintoknownresistors� InEnSealmode,performoutputverificationbydrivingapredeterminedoutputpowercurveintoknownresistors� IfGeneratorG11exhibitspoweroutputoutsideoftheacceptableranges,contactyourlocalrepresentativeforinstructions�Forrepair, GeneratorG11mayalsobereturnedtoanauthorizedEthiconEndo-Surgeryservicefacilityatanytime� Note: EnSealisusedtodescribeinstrumentsdrivenbyradiofrequency(RF)power�  GeneratorG11,V1�0...
  • Page 25 Generator G11 Service Manual Output Drive Specifications Themaximumoutputslistedinthefollowingtablesrepresenttestpointsforoutputverificationofthegenerator�Theoutputsarenotthe maximumthatthegeneratoriscapableofproducing�Instead,thetestpointsreflectloadsthatareavailablefromoff-the-shelfElectrosurgical Analyzers�Notalloftheseoutputsarecurrentlyavailableclinically�AccesstotheseoutputsiscontrolledbytheGEN11VK,whichplacesthe generatorinverification-onlymode� Table 2 – Harmonic Maximum Output Drive Specifications Activation Switch Current Amps (RMS) Voltage VAC (RMS) Power (Watts) MIN/EnSeal 0�2 0�4 Table 3 – EnSeal Maximum Output Drive Specifications...
  • Page 26 Generator G11 Service Manual Output Verification Procedure 1� TurnofftheGeneratorG11� 2� Connectthefootswitch(FSW11)tothefootswitchreceptacleonthebackpanelofthegenerator� 3� Connecttheoutputverificationkey(GEN11VK)totheGeneratorG11frontpanelreceptacle� Figure 37 GEN11 Verification Key 4� ConnecttwostandardtestleadstotheHarmonicoutputoftheverificationkey� Figure 38 Standard Test Leads Note: ThefollowingfigureillustratesthethreeactiveconnectionsoftheverificationkeywhenpluggedintotheGeneratorG11: Figure 39 Three Active Connections  GeneratorG11,V1�0 2011-04...
  • Page 27 Generator G11 Service Manual 5� ConnecttheotherendofthestandardtestcablestotheElectrosurgicalAnalyzer� 6� Power-uptheGeneratorG11�Afterthepower-upsequence,thefollowingscreenshoulddisplayonthetouchscreen� Figure 40 Secure Settings 7� Select“OutputVerification”onthetouchscreen,asshownbelow� Figure 41 Output Verification To Verify Harmonic Power Output 8� Thefollowingscreenwillappear: Figure 42 Harmonic Enabled  GeneratorG11,V1�0 2011-04...
  • Page 28 Generator G11 Service Manual Warning: EnsurethemodeselectedonthetouchscreenisthesameasthemodepluggedintoontheGEN11VK�Incorrectlyplugging cablesintowrongreceptacleswillresultinincorrectoutputpowerreadings� 9� SettheElectrosurgicalAnalyzerloadresistorto150Ohms� 10� ActivatetheHarmonicMINoutputbypressingtheMIN/EnSealfootpedalonthefootswitchassembly� 11� WhileactivatingtheMINoutput,measuretheoutputpowerandrecordinTable4-HarmonicMINOutputPowerVerification� Note: Alltablesreferredtointhisprocedureareprovidedattheendofthissection� 12� ReleasetheMIN/EnSealfootpedalonthefootswitchassemblytode-activatetheHarmonicMINoutput� 13� Repeatsteps9-12witha650Ohmresistoranda1250Ohmresistor� 14� SettheElectrosurgicalAnalyzerloadresistorto150Ohms� 15� ActivatetheHarmonicMAXoutputbypressingtheMAXfootpedalonthefootswitchassembly� 16� WhileactivatingtheMAXoutput,measuretheoutputpowerandrecordinTable5-HarmonicMAXOutputPowerVerification� 17� ReleasetheMAXfootpedalonthefootswitchassemblytode-activatetheHarmonicMAXoutput� 18� Repeatsteps14-17witha650Ohmresistoranda1250Ohmresistor� 19� Usingthetouchscreen,selectNeitherEnabled,asshownbelow� Figure 43 Neither Enabled 20� UnplugthestandardtestcablesfromtheHarmonicoutputoftheverificationkey� 21� ConnectthestandardtestcablestotheEnSealoutputoftheverificationkey� To Verify EnSeal Power Output 22� Usingthetouchscreen,select“EnSealEnabled”,asshownbelow�...
  • Page 29 Generator G11 Service Manual Warning: EnsurethemodeselectedonthetouchscreenisthesameasthemodepluggedintoontheGEN11VK�Incorrectlyplugging cablesintowrongreceptacleswillresultinincorrectoutputpowerreadings� 23� SettheElectrosurgicalAnalyzerloadresistorto50Ohms� 24� ActivatetheEnSealoutputofthegeneratorbypressingtheMIN/EnSealfootpedalonthefootswitchassembly� 25� WhileactivatingtheEnSealoutput,measuretheoutputpowerandrecordinTable6-EnSealOutputPowerVerification� 26� ReleasetheMIN/EnSealfootpedalonthefootswitchassemblytode-activatetheEnSealoutput� 27� Repeatsteps23-26witha100Ohmresistoranda200Ohmresistor� 28� PowertheGEN11generatordown� 29� Removethestandardtestcablesandverificationkey� 30� ExaminetherecordedvaluesfortheHarmonicandEnSealoutputs,comparetoacceptableminimum/maximumlimitsandrecordthe PASS/FAILcolumn�  GeneratorG11,V1�0 2011-04...
  • Page 30 Generator G11 Service Manual Table 4 – Harmonic MIN Output Power Verification Load Resistor Target Power Minimum Power Measured Power Maximum Power Pass / Fail (Ohms) (Watts) Limit (Watts) (Watts) Limit (Watts) Harmonic 4�50 7�70 22�23 30�03 1250 42�75 57�75 Table 5 –...
  • Page 31: Final Inspection

    6� PluginfootswitchtoreceptacleinRearAirPlateandensurethatthegeneratorisactivatedbythefootswitch� 7� PluginHarmonicdevice(handpiecewithinstrument)intothegenerator�Activatetheinstrumentusingfootswitchfor2secondstorun test�(Ifusingshears,keepthejawsopen�)Ensurethatgeneratorisactivatingbyverifyingwithwaxblockorwater� 8� PluginEnSealdeviceintothegenerator�Clampthedevicejawsontoapieceofdampchamoisorpapertowel�ActivateEnSeal instrumentusingthefootswitch�Ensurethatgeneratorisactivatedbyobservingwaterevaporation� 9� PluginHarmonicdevice(handpiecewithinstrument)intothegenerator�Activatetheinstrumentusinghandswitchfor2secondstorun test�(Ifusingshears,keepthejawsopen�)Ensurethatgeneratorisactivatingbyverifyingwithwaxblockorwater� 10� PluginEnSealdeviceintothegenerator�Clampthedevicejawsontoapieceofdampchamoisorpapertowel�ActivateEnSeal instrumentusingthehandswitch�Ensurethatgeneratorisactivatedbyobservingwaterevaporation� 11� Duringthegeneratoractivation,ensurethespeakerisfunctioning� 12� Duringthegeneratoractivation,ensurethatfansarefunctioning� Generator G11 Functional Test Results DeviceSerialNumber: Output Verification Passes Test Pass Fail On/OffButtonActivates AudibleSpeakerBeeps/Powerswitchglowsgreen LCDPowersup TouchScreenFunctions LCDImageChanges Footswitchactivatesthegenerator GeneratoractivatesaHarmonicloadwithfootswitch GeneratoractivatesanEnSealloadwithfootswitch GeneratoractivatesaHarmonicloadwithhandswitch GeneratoractivatesanEnSealloadwithhandswitch...
  • Page 32 Generator G11 Service Manual Chapter 5 - Assembly Diagram and Spare Parts List Main Assembly Diagram Figure 45 - Main Assembly Diagram  GeneratorG11,V1�0 2011-04...
  • Page 33: Spare Parts List

    Generator G11 Service Manual Spare Parts List ThefollowingreferencenumberscorrespondtothenumbersinFigure 45 - Main Assembly Diagram� Item No. Part Number Description EE01-63095 MainPCBAssembly EE65-00002 7”LCDDisplay(Hitachi) EE99-00007 PowerEntryModule,Fused5A EE70-00001 PowerSupply,48V400W(Condor) EE40-00005 Fuse5A250VSlowburn5x20mm(PowerEntry) EE45-00036 M3Nutwithcaptivewasher(PowerEntry)(SeeNOTE3) EE20-00021 AdapterPlate EE20-00022 EnclosureBottomDecoAssembly EE20-00025 EnclosureTopDecoAssembly EE15-00031 POAG-S6-15Equipotential EE45-00003 F/M6LockWasher(Equipotential) EE45-00002 MUO�5D/M6Nut(Equipotential)(SeeNOTE4)
  • Page 34 Generator G11 Service Manual Item No. Part Number Description EE00-00002 SpeakerAdhesivePad EE20-00026 BezelGutterGasket EE05-00014 CableAssembly,MainBoardtoChassisGround EE30-00009 Ferrite,Footswitch EE30-00008 Ferrite,Receptacle EE45-00050 #8Internal-ToothLockWasher EE99-0015 DampingTrim EE40-00009 Fuse,2Amp(MainBoard) EE40-00008 Fuse,8Amp(MainBoard) EE00-00010 FoamEndCap-Left EE00-00011 FoamEndCap-Right EE05-00012 PowerCord13Amps,125V,15Feet EE00-00013 Anti-StaticBag20”x24” EE00-00014 CorrugatedBoxforGEN11 NOTE: Note No.
  • Page 35 Generator G11 Service Manual Cart (CRT11) Figure 46 - Cart Cart (CRT11) Parts List Item No. Part Number Description ETH2600 Caster,Locking(2Places) ETH2660 Caster,Swivel(2Places) ETH2700 DeviceRetentionScrew ETH2800 Grommet(2Places) ETH2900 Thisisthefullhardwarekitthatincludes8screws,flatwashersandlockwashersfor theuprightaswellasthe4lockwashersforthecasters� *Allscrewsmustbetorquedto70-80in/lb�  GeneratorG11,V1�0 2011-04...
  • Page 36 Generator G11 Service Manual Appendix Electrical Safety Test Parameters Electricalsafetytestsarerecommendedtobeperformedonaregularlyscheduledbasisinaccordancewithfacilityguidelines�Thefollowing testprocessesandparametersarerecommendedinaccordancewiththesafetystandardsspecifiedinthismanual� Table 1 – Ground Bond Test Test Parameter Test Name / Description Units Consultlocalrequirements TotalResistance 0�100 0�001 Ohms Table 2 – Patient Applied Part Circuit Dielectric Test Note: Itisrecommendedonlyifaserviceorrepairtothepatientconnectedcircuitismade�...
  • Page 37 OUT1 OUT1...
  • Page 39 OUT1 OUT1 GND1 NC-1 OUT1...
  • Page 40 NC-2 NC-2...
  • Page 42 NC-1...
  • Page 43 COMP COMP COMP COMP NC-2 NC-4 NC-5 COMP COMP NC-2 NC-4 NC-5...
  • Page 44 Generator G11 Service Manual Additional Hardware Troubleshooting Information Note: Voltageslistedare+/-10%unlessotherwiseindicated� TP2, TP3, TP4, TP5 Footswitch signals (Top left one is TP2) J4 Power Supply input out J8 Enclosure Fan TP27 HS out J27 heat sink fan TP62 RF out J23 – speaker...
  • Page 45 Generator G11 Service Manual Troubleshooting Using PCB Interface Signals: InterfacefromPCBto: i� LCDDisplay • Backlightconnector(J25) • 12VDCatJ25�1 • LCDconnector(J29) 1� Checkforgoodconnection� 2� CheckforclockonLCD_DOTCLK(FB22orR167)UIprocessorissendingaclocktoLCD� Figure 48 3� Checkfordatatimingsignal(nexttodotclocksignalthirdfromtherightinFigure48)�ThisshowstheUIisproperlywriting andrefreshingtheLCDwithdata�Ifthissignaldoesnotexist,thenthePCBisdefective� Figure 49  GeneratorG11,V1�0 2011-04...
  • Page 46 Generator G11 Service Manual 4� CheckforLCDCCsignal(veryend–firstonthetopleftinFigure49�)Ifthissignaldoesnotexist,thentheLCDisdefective� Figure 50 ii� Speaker • Speakerconnector(J23) 1� CheckV+(J23�1)andV-(J23�2)foractivitywhensignalisexpected� • Nosignalbothpins~+5�6VDC • Whenactivatingsee~2Vp/psignalridingon~+5�6VDC • Ifthissignaldoesnotexist,thenthePCBisdefective� Figure 51  GeneratorG11,V1�0 2011-04...
  • Page 47 Generator G11 Service Manual 2� Thespeakercurrent(I_SPKR)feedstoacomparatorandoutputsAUDIO_SNS(TP60)�Thistestpointshouldindicate3�3V whenthespeakercurrentpassesacertainthreshold�Ifthereisactivationwithoutcurrent,thenthespeakerisdefective�Ifthere isnocurrentwhenaudiosignalinstepaboveispresent,thenthespeakerisdefective� Figure 52 iii�HandpieceReceptacle Checkforcontinuitybetweenhandpieceinputsanditsconnectors� 1� J24pins1-5�J24 • Pin4ispresence(alsoTP64)-Pin4toPin3isshortedwhenHPispresent • EEPROMdataonPin1 • HandswitchsignalsonPin5(andalsofutureinstrumentEEPROMsignal) 2� J28powerdrivesignalstotheinstruments� • Pin1(TP62)isRFout(EnSealoutputsignals) • Pin9(TP27)isHSout(Harmonicoutputsignals) • Pin3isgroundreturn iv�FootswitchReceptacle ConnectstoJ5� 1� FSW_MON(TP2)isexpectedtofollowtheFSW_CLKsignalalmostexactly�(CheckifalltheFETsareswitchingproperlyto keeptrackofthePCBcircuitry�)  GeneratorG11,V1�0 2011-04...
  • Page 48 Generator G11 Service Manual 2� FSW_CLK(TP1)isexpectedtobea2kHzsquarewave(0to3�3V)� Figure 53 3� FSW_PRS(TP3)isexpectedtobe3�3Vwhenfootswitchispresent�FSW_PRSsignaldipslowoneveryedgeoftheclockif footswitchisnotpresent�Stayshighiffootswitchispresent� Figure 54 4� FSW_MAX(TP4)–If“MAX”ispressed,thissignalisexpectedtobe3�3VaftertherisingedgeofFSW_CLK�Dipslowif MAXpedalisnotpressedonrisingedgeoftheclock� 5� FSW_MIN(TP8)–If“MIN”ispressed,thissignalisexpectedtobe0VafterthefallingedgeofFSW_CLK�Normallylow, spikeshighonthefallingedgesoftheclockwhentheMINpedalisnotpressed,butwillstaylowwhenthepedalispressed� v�PowerSupply • ACpowerinletandcableassembly� • Checkfor48VatJ4�1withrespecttoGNDatJ4�6oranyGNDtestpoint�  GeneratorG11,V1�0 2011-04...
  • Page 49 Generator G11 Service Manual vi�BezelPCB • BezelBoardConnector(J30) 1� CheckUI_SPI1_MISO,(J30�2)forperiodicactivity–whichmeansthatPCBistryingtocommunicatetoBezel� Figure 55 2� ChecklevelofN_BEZEL_CS(J30�6)�Itshouldbehigh(3�3V)fornormalactivity�Ifitisnothigh,itindicatesproblemswith thePCB� 3� ChecklevelofBEZEL_RST(J30�7)�Itshouldbelowundernormalconditions�Ifitishigh,itindicatesproblemswiththe PCB� 4� ChecklevelofINHIBIT_LATCH(J30�10)�Itshouldbehigh(3�3V)innormaloperation�Iflow,itindicatesaproblemwiththe BezelPCB� 5� ChecklevelofBRDPWRON_LATCH(J30�11orR325)�Itshouldbehigh(3�3V)innormaloperation�Iflow,itindicates problemwiththeBezelPCB� 6� Removethepowersupplycontrolcabletotestifthegeneratordoesnotturnon�AllowsgeneratortoturnonifBezelPCBis notoperating� vii�Fans • EnclosureFanConnector(J8) 1� Checkfor48VatJ8�1�Ifthefandoesnotmoveandthisvoltageispresent,thenthefanisdefective� 2� Pin3istachsignalcomingbackfromfan� 3� Pins4and5arerelatedtofanspeedforfuturefunctionality� • HeatsinkFanConnector(J27) 1� Checkfor48VatJ27�1�Ifthefandoesnotmoveandthisvoltageispresent,thenthefanisdefective� 2� Pin3istachsignalcomingbackfromfan�...
  • Page 50 Generator G11 Service Manual Power versus Load Curves Power versus Load Resistance (Impedance) 160.00 3.50 Voltage 140.00 3.00 Power Current 120.00 2.50 100.00 2.00 80.00 1.50 60.00 1.00 40.00 0.50 20.00 0.00 0.00 -150 1050 1250 Load Impedance, Ohms Figure 56 - Electrosurgical Power versus Load Resistance A Graph of Voltage, Current and Power vs.
  • Page 51 Generator G11 Service Manual Voltage versus Load Resistance (Impedance) A Graph of Voltage Measurement and Uncertainty vs. Load Impedance Voltage Voltage Measurement Low Voltage Measurement High Load Impedance Figure 57 - Electrosurgical Voltage Measurement versus Load Impedance Impedance Measurement versus Load Impedance A Graph of Impedance Measurement and Uncertainty vs.
  • Page 52 Generator G11 Service Manual Measurement Uncertainity versus Load Impedance A Graph of Measurement Uncertainty vs. Load Impedance 25.00% 20.00% 15.00% % Error, Current % Error, Voltage % Error Power % Error Impedance 10.00% 5.00% 0.00% 1000 1500 2000 2500 3000...
  • Page 53 Generator G11 Service Manual System Specifications MainFuses T5AL250V(Time-delay,5Amp,glassbody,5x20mmpackagesize,quantity:2) DegreeofProtectionAgainstElectricShock TypeCFappliedpartconsistingoftheHarmonicorEnSealinstruments ClassofProtectionAgainstElectricShock Class1 IngressProtectionG11Enclosure IP21 IngressProtectionG11Footswitch IP68 MainInput 100-240V ,50/60Hz,500VA EnSeal Output: Output Bipolar,noneutralelectroderequired 100VACRMSmaximum 135wattsmaximum(ratedload15ohms) 300-490kHz(330kHzunlessotherwisemarkedininstrumentIFU) Harmonic Output: 150VACRMSmaximum 35wattsmaximum 30-80kHz(55�5kHzunlessotherwisemarkedininstrumentIFU) AmbientOperatingConditions Temperature:59°Fto80�6°F,15°Cto27°C Humidity:30%-75%non-condensing AtmosphericPressureRange:700hPa-1060hPa TransportandStorageConditions Temperature:-31°Fto129�2°F,-35°Cto+54°C Humidity:10%-95%non-condensing AtmosphericPressureRange:700hPa-1060hPa Weight Generator:13lbs(5�9kg)
  • Page 54 Generator G11 Service Manual Electromagnetic Compatibility (EMC) TheGeneratorG11requiresspecialprecautionsregardingelectromagneticcompatibility(EMC)andmustbeinstalledandusedinaccordance withtheEMCinformationprovidedinthisguide�TheGeneratorG11isintendedforuseintheelectromagneticenvironmentsspecifiedbelow� Caution: EnsurethattheGeneratorG11isusedonlyintheseenvironments� Electromagnetic Emissions Emissions Test Compliance Guidance RFemissions Group1(perIEC TheGeneratorG11usesRFenergyonlyforitsinternalfunction� 60601-2-2:2009) Therefore,itsRFemissionsareverylowandarenotlikelyto CISPR11 causeanyinterferenceinnearbyelectronicequipment� RFemissions ClassA TheGeneratorG11issuitableforuseinallestablishmentsother thandomesticandthosedirectlyconnectedtothepublic CISPR11 low-voltagepowersupplynetworkthatsuppliesbuildingsused fordomesticpurposes� Harmonicemissions Notapplicable IEC61000-3-2 Voltagefluctuations/flicker Notapplicable emissions IEC61000-3-3 Electromagnetic Immunity Guidance Forelectromagneticimmunity,essentialperformanceis:activationtonesarecoupledwithenergyoutput,energyoutputceaseswhen activationswitchesareopened,andthereisnoenergyoutputwithoutactivationswitchclosure�...
  • Page 55 Generator G11 Service Manual VoltageDips, <5%U (95%dipinU for <5%U (95%dipinU for Mainspowerqualityshouldbethat ShortInterrupts, 0�5cycles) 0�5cycles) ofatypicalcommercialorhospital andVariations <40%U (60%dipinU <40%U (60%dipinU for environment�Iftheuserofthe onPowerSupply for5cycles) 5cycles) GeneratorG11requirescontinued Lines <70%U (30%dipinU <70%U (30%dipinU for operationduringpowermains IEC61000-4-11 for25cycles) 25cycles) interruptions,itisrecommendedthat <5%U <5%U theGeneratorG11bepoweredfrom (>95%dipinU...
  • Page 56 Generator G11 Service Manual Recommended separation distances between portable and mobile RF communications equipment and the Generator G11 TheGeneratorG11isintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled�Thecustomer ortheuseroftheGeneratorG11canhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweentheportable andmobileRFcommunicationsequipment(transmitters)andtheGeneratorG11asrecommendedbelow,accordingtothemaximumoutput powerofthecommunicationsequipment� Rated maximum output power of Separation distance according to frequency of transmitter transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz...
  • Page 57 Generator G11 Service Manual Conformance to Standards TheGeneratorG11conformstothefollowinginternationalstandards: EN (IEC) 60601-1 Medicalelectricalequipment-Part1:Generalrequirementsforbasicsafetyandessential (with Canadian and US National Deviations) performance EN (IEC) 60601-1-2 Medicalelectricalequipment-Part1-2:Generalrequirementsforbasicsafetyandessential performance-Collateralstandard:Electromagneticcompatibility-Requirementsandtests EN (IEC) 60601-2-2 Medicalelectricalequipment-Part2-2:Particularrequirementsforthesafetyofhighfrequency surgicalequipment EN (IEC) 60601-1-8 Medicalelectricalequipment-Part1-8:Generalrequirementsforbasicsafetyandessential performance-Collateralstandard:Generalrequirements,testsandguidanceforalarmsystems inmedicalelectricalequipmentandmedicalelectricalsystems  GeneratorG11,V1�0 2011-04...
  • Page 58 Generator G11 Service Manual Symbols Footswitch Non-ionizingRadiation EquipotentialGroundLug ElectricalandElectronicequipment�Returnwastetoacollectionsystemortreatmentand recyclingfacilities�ApplicableintheEU�Followdecontaminationinstructionsbefore returningwaste� AuthorizedRepresentativeintheEuropeanCommunity Manufacturer On/OffSwitch Caution:Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofaphysician� KeepDry DateofManufacture ReorderNumber SerialNumber AuthorizedRepresentativeintheUSA  GeneratorG11,V1�0 2011-04...
  • Page 59 Generator G11 Service Manual Refertoinstructionsmanual/booklet� Non-sterile CFAppliedPart(DeviceConnector) Theelectronicinformationproduct(EIP)hasmettherequirementssetforthbythePeople’s RepublicofChinaformarkingofEIPs,andcanbeusedduringitsenvironmentalprotection useperiodof50years�Aftertheenvironmentalprotectionperiodhasexpired,theEIPshould berecycled�ApplicableinthePeople’sRepublicofChina� Fuse ProductiscertifiedbyaNationallyRecognizedTestingLaboratory� ConsulttheGeneratorG11Operator’sManual� RecyclablePackaging RelativeHumidity Temperature LowAlarm MediumAlarm  GeneratorG11,V1�0 2011-04...
  • Page 60 Hummelsbuetteler Steindamm 71 Tengrant LLC 22851 Norderstedt Tel.: +86(021)5428 6005 GERMANY Fax: +86(021)5428 6005-8002 www.tengrant.com Ethicon Endo-Surgery, Inc. 4545 Creek Road, Cincinnati, OH 45242-2839 USA 1-800-USE-ENDO  ETHICON ENDO-SURGERY, LLC © EES, LLC 2011 Guaynabo, Puerto Rico 00969 USA Rev. 2011-04 P43566P02...

Table of Contents

Save PDF