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SUMMIT HILL LABORATORIES Tinton Falls Business Center 1 Sheila Drive Tinton Falls, NJ 07724 Phone: (732) 933-0800 Fax: (732) 933-0055 Email: [email protected] www.summithilllaboratories.com
VETROSON® V-10 BIPOLAR ELECTROSURGICAL UNIT
OPERATING INSTRUCTIONS
2
TABLE OF CONTENTS
3 Frontpanel(controlfunctions,indicators,jacks)
4 Rearpanel(powercordapplianceentry,footpedal,toneswitch)
5 Monopolarandbipolar
5-6 Electrosurgicalcurrentquality
6-7 Powersetting(whatelectrosurgeryisandisnot;howtoadjust);Surgical
Technique
7 Initialpowersettings
8 Electrodes,handpiece,Flexibleindifferentplateandcable,andbipolarforceps
cleaningandsterilization
9 Electrode,handpiece,andcablesterilizationandcare
10PrecautionsPLEASEREADandOBSERVE!
11 Generalhintsandadvice
12 Coagulationhintsandadvice
13 Resolvingoperationaldifficulties
14 Warrantyandrepairs
3
OPERATING INSTRUCTIONS
FrontPanel
VETROSON®V-10generatesradiofrequencyelectricalenergywhichmayinterferewithotherequipmentadverselyaffectingthatequipment.
1PowerON/OFF(I=ON,O=OFF)
2ACpower“on”indicator(lightsgreenwhenACpowerison)
3“Stabilizing”indicatorcomesonautomaticallyuponpowerswitchingontoallowunittostabilize.Afterabout
25secondsindicatorwillgooffandunitisready.Theunitwillnotactivatewhileindicatorison!
4RFactiveindicatorlightsyellowwhenenergyispresentattheselectedjacks
5Electrosurgicalcurrentqualityselect(“mode”a.k.a.“waveform”)
6RFPowercontrol(electrosurgicalcurrentquantity)
7Monopolaractivejack(monopolarhandpieceblackpluggoeshere)
8Monopolar/bipolarswitch(onlyonepairofjacksmaybeactivatedatatime)
9Bipolarjacks(bipolarcordplugsinhere(nopolarity)NEVERplugabipolarleadintoamonopolarjack!
10Monopolardispersivejack(currentreturnfromtheelectrode)V-10isanisolatedunitandwillnotworkin
monopolarwithoutthegroundpadpluggedinandproperlyplaced!
SymbolfortypeBFAppliedPart.Indicatesisolatedfromgroundathighfrequencyandahighdegreeofelectricalshockprotection.
Symbolforfloating.Isolatedfromgroundathighfrequencyandahighdegreeofelectricalshockprotection.
4
RearPanel
1 Hospitalgradepowercordgoeshere(polarized,onlygoesinoneway)pushinfirmly2 Footpedalcablepluggoeshere(keyed,onlygoesinoneway)goesineasily,donotforce3 ActiveaudibletoneNormal/Softsetting(up=normal,down=soft)
Howgrounddispersivepadconnectstodispersivecable
5
MonopolarandBipolarMonopolarelectrosurgicalcurrentisusedforincision,excision,andcoagulation.
Monopolarelectrosurgicalcurrententersthebodyatthesurgicalsitewhereaveryhighlyconcentratedcurrentdensityinducesheatendogenouslywithintheindividualcellsmakinguptissue.
Theelectrosurgicalcurrentreturnstothegeneratorviathedispersivepad(a.k.a.”indifferentpad”orNE“neutralelectrode”)overaverylargeareawithlowcurrentdensityandnoheatdevelopment.
Bipolarelectrosurgicalcurrentisusedforcoagulation.
Bipolarelectrosurgicalcurrentremainsconstrainedtotheimmediatevolumeoftissuegraspedbetweenthetipsofthetwoinsulatedforcepsblades.asshownhereforelectrocoagulationofavessel.
Inbipolaroperationelectrosurgicalcurrentdoesnottraversethebodyinordertoreturntothegeneratorasinmonopolaroperation
Bipolarelectrosurgicalcurrentmayalsobeappliedsuperficiallyontissuebyholdingtheforcepstipsapart.Theelectrosurgicalcurrentmaybeappliedin“hard”or“forced”manneror“soft”manner.
Usingthebacksideofcurvedforcepsheldapart,electrosurgicalmaybeappliedoverlargeareasbybrushingtheareawiththeforceps.Athincoagulumdevelopsinthatmethod,similartofulgurationbutwithouteschar.
ElectrosurgicalCurrentQuality(a.k.a.“mode”or“waveform”)
TheFINE(Filtered)currenthasthelowestdegreeofcollateraltissuedenaturingbutalsothelowestdegreeofconcurrenthemostasis.Itisusedwherecollateralheatandcicatrixformationareclinicalconcerns,i.e.,dermatologicalindications,cosmeticindications,biopsy,graftdonortissueharvesting,oculo-plasticindications,anddentalindications.
Crestfactorisameasureofcoagulationability(thehigherthenumberthemoreeffectivethecoagulationability)andCUThasacrestfactorof1.4.
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TheNORMAL(FullyRectified)combineselementsofcuttingcurrentandcoagulationcurrentsoastoprovidesignificantandeffectiveconcurrenthemostasisduringincisionandexcision.“NORMAL”isthe“generalpurpose”electrosurgicalcurrentandismostoftenused.
NORMALhasacrestfactorof1.9whichisaproveneffectivebalancebetweenconcurrenthemostasisandfasthealingduetominimalcollateraltissuedenaturing.
TheCOAGelectrosurgicalcurrentisusedtocontrolbleeding.Itmaybeappliedinmonopolarusingtheballelectrodein“hard”(a.k.a“forced”)applicationorelsein“soft”application.
CrestfactorinCOAGis2.7whichisrelativelymildyeteffectiveallowinggoodcontrolovertheeffectsandminimalcicatrixformation.
Bipolarmodeselectionautomaticallyselectsthiselectrosurgicalcurrent.
TheelectricalcharacteristicsoftheCUT,BLEND,andCOAGonanoscilloscopeareillustratedbelow:
FINENORMALCOAG(FILTERED)(FULLYRECTIFIED)
RFPOWERSETTING
Electrosurgeryisuniqueamongsurgicaltechnologieshavingcharacteristicswhichmustbetakenintoaccountwhenapplyingitclinicallyinordertoachievepositiveclinicaloutcomes.
1ElectrosurgeryisNOTCAUTERIZATION!Incauterizationheatisproducedoutsidetissueandthenbroughtintocontactwithtissuecausingsignificantcollateraltissuedamage.
ElectrosurgerydevelopsheatendogenouslywithintissuecellsandtheelectrodeDOESNOTgethotoutsidetissue.
Becauseelectrosurgicalcurrentreactswithtissuecellcontents,itwillNOTREACTwithinorganicsorelectricalinsulatorssuchaswood,plastic,orpaper.
2Theamountofelectrosurgicalcurrent(powersetting)necessarytoperformasurgicalprocedureisafunctionofelectrodesurfacearea(sizeandshape).Thereisathresholdbelowwhichitwillnotwork,thatistosay,aminimumsetting.ItisNOTlikeastovewith“simmer”,“medium”and“high”andcannotbedialedbelowtheminimumthresholdsettingandstillcutorcoagulate.
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3Surgicaltechniqueisaverysignificantfactorinclinicalefficacywhenusingelectrosurgery.PracticeontestmediabeforeusingtheVETROSON®V-10inclinicaluseonpatients!
4AdjustingRFpowersetting(titratingthedose)
• Waytoolow,nocuttingjustcoagulationburn• Toolow,dragging,tissueadheringtoelectrode
• Justright:pressurelesssmoothcleancutting• Toohigh,sparking,proteindepositsonelectrode• Waytoohigh,sparking,charring,carbondepositsonelectrode
NOTE:theflatsideofR71andR72lancetmaybeusedeffectivelyforcoagulation
RFPowerInitialSettingsbipolar(subjecttosubsequentadjustment)
coagulation bipolarforceps 4½to5 coag
indication electrode RFpower waveform
incision<2mm M-1,M-10,M-F11 3to3.5 Fine(Filtered),Normal(FullyRectified)
incision>3mm M-1,M-10,M-11 4to4.5 Fine(Filtered),Normal(FullyRectified
ablation M-1,M-10,M-11 2to21/2 Fine(Filtered)
ablation M-61 2to21/2 Fine(Filtered)
ablation M-51 31/2to4 Fine(Filtered)
planning M-33 5 Fine(Filtered),Normal(FullyRectified)
planning M-34 6 Fine(Filtered),Normal(FullyRectified)
coagulationhard M-51 6to7 coag
coagulationsoft M-51 7 coag
incision M-71,M-72 6to8 Fine(Filtered),Normal(FullyRectified)
8
Electrodes
OptionalElectrodes
Number Description
M-10 Finewireincision;straightshaft
M-61 Fineneedle;incision,ablation,fulguration
M-62 Pointedtipfulguration
M-71,M-72 lancet
Number Description
M-1 Finewireincision;adjustabledepth;angledshaft
M-11 Finewireincision;angledshaft
M-33 5mmloop
M-34 10mmloop
M-51 1.5mmcoagulationball
9
ElectrodeHolderBlock
The2½”x2½”plasticelectrodeblockholdsupto25electrodesandmaybeusedduringsurgeryasaholder
ElectrodeandHandpiecesterilization
Steam autoclave at 270°F(132°C)for15minutes.Thenosecapshouldberemovedduringautoclave.Coilthecordlooselywhenplacinginanautoclavebag.Allow15minutescoolingtime.FDAdoesnotrecognizechemicalsterilizationasadequateforelectrosurgery.ElectrodehygieneTheactivemetalportionsofelectrodes(boththetissuecontactareasandthepartheldinthehandpiece)mustbecleanandfreeofoxidesandproteindepositsinordertoelectricallyconductelectrosurgicalcurrent.Theseareasmaybepre-cleanedpriortoautoclavewithaquaternarydisinfectantandscrubbedwithasuitablemediasuchasScotchbrite©“maroon”pads.Theelectrodespre-cleanedwithdisinfectantshouldberinsedafterwordspriortoautoclave.Donotsoak!DispersivegroundpadhygieneThegroundpadmaybecleanedwithasuitablequaternarydisinfectant.Donotsoakthegroundpad!Thegroundpadmaybesteamautoclavedat270oF(132oC)for15minuteswitha15minutedryingtime.Ifautoclaving,thepadshouldbelooselywoundupwithalayerofgauzetoallowsteamtoreachtheentiresurfaceofthecoiledpad.Dispersivegroundcable,bipolarcableandbipolarforcepsThesearealsoautoclaveable.Likethehandpieceshouldbecoiledlooselyintheautoclavebag.Steamsterilizeat270oF(132oC)for15minuteswitha15-minutedryingtime.Likeelectrodesanddispersivepad,theseitemsmaybepre-cleanedwithaquaternarydisinfectantandrinsedpriortoautoclave.Donotsoak!Gassterilizationhasnotbeeninvestigatedfortheaboveproductshencenorecommendationcanbemade.Dryheatwilldamageelectrodes,cables,andgroundpad.
10
Dispersivegroundpadplacement
Thisaspectofelectrosurgeryisessentialforsuccessfulclinicaluse.
Thedispersivegroundpadisacapacitivetypeanddoesnotrequireanydirectelectricalcontactwithbareskinandwillworkthroughfur.Noadhesivesorgelsareneededorused.
Generalrulesare
• Insurethattheentireareaofthedispersivegroundpadiscoveredbythepatient• Placeoveralargewellvascularizedmusclemass• Placeasneartothesurgicalsiteaspractical
Theleastfurryareasofthepatient’sanatomyarebetter;forexample,insidethethighonlargedogs,onthehaunchesforequineandbovine.Thepatientindifferentplatemaybeheldinplacewithlooselywrappedgauze.Thepatientindifferentplateisflexibletoconformtobodycontoursformaximumcoverage.
Precautions
Electrosurgeryuseshighradiofrequencyelectricalcurrentwhichisinherentlydangerousunlesshandledproperly.Pleasefollowtherecommendationsforsafe,effectiveuseandpositiveclinicaloutcomes.
Fireandexplosionhazard:
• DONOTusewithflammableanesthetics!• Allowalcohol-basedastringentstocompletelydryandevaporatebeforeusingelectrosurgery.• Donotusewithoxygenornitrousoxide!DiscontinueO2orN2Oduringelectrosurgery!Re-establish
afterwards.• DonotallowO2orN2Otopoolunderasurgicaldrape!• RemovecottonorgauzefromcavitieswhereO2orN2Oarepresentbeforeelectrosurgery!Replace
afterwards.
Pacemakersandotherimplantedelectricalmedicaldevices:
• Alwaysconsulttheimplanting/referringphysicianbeforeusingelectrosurgery(patient,operator,orstaffpersonnel).Generallyspeaking,pacemakersareRFshieldedandsafeforusewithelectrosurgery.Caution:theonlywaytoknowistoasktheimplantingphysician.Someotherimplanteddevicesmaynotbeshieldedorsafe;alwaysask!
Smoke:electrosurgicalsmokeisvaporizedtissuecellcontents.FDAandCDCregarditasamildcarcinogenifinhaledsufficientlyoverextensivetime,therefore,theuseofasuitablesmokeevacuatorisverystronglyadvised.Virusmaybepresentinelectrosurgicalsmoke.Ifapatientisknowntohaveactiveviralinfection,takeadditionalmeasuresforsurgeonandstaffrespiratoryprotection.
11
Iftheelectrosurgicalgeneratorappearstolosepower:
DONotturnupRFpowertoadangerouslevel!Firstdothis:
• Checkthedispersivepadforpositionandfirmconnectiontothegenerator• Besurethewrongcurrentqualityisnotselected(i.e.,COAGinsteadofFINE(Filtered))• Besuretheproperpowersettingisset(seeinitialsettings)• Besurethattheelectrodeiscleanandnotcompromisedbyproteindepositorcarbon• Besurethatcablesareintactandfunctional(substituteasparetoverify)
Metallicinstrumentsorobjects(includesimplantsandamalgams,jawwiring,orthopedicbraces)Electrodecontactwithametalinstrumentorobjectwillmaketheobjectanextensionoftheelectrodeandelectrosurgicalcurrentwillentertissuewherevertheobjectisincontactresultinginburns.
• Avoidcontactwithmetalobjectsinthesurgicalfield!• DONOTallowelectrosurgicalcablestocoilaroundmetalobjects!(magneticinductionwillcause
electrosurgicalcurrenttobegeneratedintheobject)NOTE:“buzzingthehemostat”istheobviousexceptiontotheaboveElectrodeheatIntenseintracellulartissueheatwillheattheelectrodewhichwillremainhotafterelectrosurgery.
• Withdrawtheelectrodefromthesurgicalsitecautiouslytoavoidtissuecontact.• Allowadequatecoolingtimebeforehandlingtheelectrode.
Inadvertentactivation
• Neverleaveahandpieceorbipolarforcepsrestingonapatient!Alwaysstowinproperholder.• BesurethatfootpedalisinsightandyellowRFindicatorisoffwhenchangingelectrodesorbipolar
forceps.Bone
• NEVERcontactexposedbonewithmonopolarelectrosurgeryo ContactwithmonopolarelectrosurgicalcurrentWILLnecrotizethebonenutrientforamenand
subsequentinjurywillbeamatterofdegreeo Usebipolarcoagulationnearoronexposedboneo Donotcoagulateonthedentalpalatewithmonopolarelectrosurgery(seeabove)
GeneralhintsandadviceAnesthesiaisnecessaryforelectrosurgery.
• TurnontheV-10andallowstabilizationtocompletethenactivatetheV-10brieflytoverifyitis
operationalbeforeadministeringanesthesia.
12
AvoidoverstressingtheV-10.
• Observe10secondsofoperationfollowedby20secondsde-activecoolingtime• Donotoperatethemodeswitchwiththeunitactive
Electricallysafesetup
• UseonlywithhospitalgradeNEMA15orNEMA20outlets• Donotdefeatthegroundpinonthemedicalgradepowercord• Donotuseextensioncords
Easiercleanup
• Placegroundpadinacleandisposableplasticbag• Usehandpieceprotectorsheaths(NOTasubstituteforautoclaving!)
Avoidfailuresduringsurgery(pro-activeprevention)
• Handpieces,dispersivecable,andbipolarcablehaveafiniteservicelife.o Routinelyreplacetheaboveonabi-annualschedule
• Alwayshaveaspareautoclavedhandpiece,dispersivecable,andbipolarcableonhandInspecthandpieces,cables,andforcepsforvisibleflawsbeforeautoclave
• Routinelyinspectforbaremetalshowingwhereitshouldnotbe• Replacefaultyitems!Donotattemptrepair.
Handrestfordelicateprocedures
• Fordelicateproceduresestablishahandrestonthepatient• Doacoupleof“practicestrokes”withoutactivatingtheunitbeforeproceeding
Oculoplastic
• ALWAYSusecornealshields!Dental
• AlthoughintendedforgeneralveterinarysurgerytheV-10isverywellsuitedfordentalCoagulationhintsandadvice
• Monopolar“hard”coagulationiswhentheballisplacedincontactwithtissuethentheunitactivatedo Usedfordeeppenetrationofheavybleedso Usedfordesiccationorablationoflesionso Willhavesignificantcollateraltissuedenaturing,leavescicatrix
13
• Monopolar“soft”coagulationiswhentheunitisactivatedfirstthentheballbroughtintocontactwithtissue
o Usedforsuperficialcoagulationo Relativelyshallowtissuepenetration,minimalcollateraltissuedenaturing,cicatrix
• Monopolarcoagulationisineffectiveinwetorbloodyfields
o Usespongesasrequiredtoclearthefieldbeforemonopolarcoagulation
• Ballelectrodesizeo The1.5mmballtakestheleastRFpowertooperateo Ifpowerissettoohighthe1.5mmballcanablatetissueinsteadofcoagulateo The3mmballis“generalpurpose”o The5mmballtakesaveryhighRFpowersettingandisbestsuitedto“soft”coagulation
• Bipolarcoagulationo TakeslessRFpowerthanmonopolarcoagulationo Effectiveinwetorbloodyfieldso Maybeusedlikeamonopolarballbyholdingthetipsapart
§ Blunttipsworkbestforthis§ Maybeusedas“soft”or“hard”inthismanner§ Seepage5forlargeareacoagulation
ResolvingoperationaldifficultiesUNIT Unit fails to turn on.
• Verify that the electrical outlet is functional by plugging in another appliance known good. • Verify that power cord is firmly seated in the appliance entry.
Unit turns on OK, timing indicator goes out OK, but unit will not activate when pedal is pressed.
• Verify that the foot pedal connector is attached and seated properly. • Verify that the foot pedal cord is not damaged. • Check foot pedal for obvious faults: does it “click” when pressed?
Sometimes depressing the foot pedal activates the unit, sometimes not.
• If the foot pedal is depressed on the very extreme corner it may not “click”. Be sure to step on it as fully as practical to avoid this annoyance.
NOOPERATIONThe yellow “active” indicator comes on OK, but I get no cutting.
• Verify that the “Flexi-plate” dispersive plate is plugged in at the chair and at the unit.
14
• Verify that the electrode is fully seated and insulation is not caught in the chuck. • Verify that the dispersive cable is undamaged and functional. • Verify that the hand piece cable is undamaged and functional. • Electrodes must be clean
POOROPERATION
• Verify that proper initial power setting for the electrode selected is established. • Verify that COAG has not been inadvertently selected for an incision or excision. • Verify that heavy, thick fur is not adversely affecting dispersive efficiency • Verify dispersive plate positioning
Warrantyisfor5yearsfromdateofsalefortheunit.Electrodes,cables,groundpad,andbipolarforcepsfortwoyearsfromdateofsale.RepairsCallSummitHillLaboratoriesforaReturnAuthorizationnumber(RAnumber)BEFOREsendinginaunitforservicesoastoassureproperhandlingandpromptresponse.Haveyourunitserialnumberreadywhenyoucallanddescribeyourproblem.Handwrittendescriptionsmaybepackedwiththeunit.Toavoidshippingdamagetheunitshouldbereturnedinitsoriginalpackaging.Iftheoriginalpackagehasbeendiscarded,pleaserequestonefromSummitHillforreturningyourunitforservicewhencallingforRAnumber.CAUTION:foryoursafety!TheVETROSON®V-10devicecontainsnouserserviceableparts.
• Neveropentheunityourself.• Neverattemptmodificationofthedeviceoranyaccessory.• UseonlySummitHilllaboratoriessparesandaccessories
o DonotusegenericsubstitutesSUMMITHILLLABORATORIESTintonFallsBusinessCenterOneSheilaDriveTintonFalls,NJ07724Voice7329330800FAX7329330055sales@summithilllaboratories.comVisitwww.summithilllaboratories.comforreplacementitemsalsoforavailableelectrodesandbipolarforce
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