Û fold out this page Û use and maintenance manual - dental · Û use and maintenance manual Û...

Û Use and maintenance manual

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Manufacturer:

Mectron S.p.A.Via Loreto 15/A16042 Carasco (Ge) ItalyTel. +39 0185 35361Fax +39 0185 351374www.mectron.come-mail: [email protected]

750 Communications ParkwayColumbus, OH 43214Toll Free: 888 87 PIEZO x 8Telephone: 614 459 4922FAX: 614 459 4981www.piezosurgery.use-mail: [email protected]

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Û TABLE OF CONTENTS01 Û INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 01 .1 IntendeduseofthePIEZOSURGERY®touch . . . . . . . . . . . . . . . . . . 2 01 .2 Descriptionofthedevice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 01 .3Responsibilitywaiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 01 .4 Safetyprecautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 01 .5 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 602 Û IDENTIFICATION DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 02 .1 Identificationplateofthedevice . . . . . . . . . . . . . . . . . . . . . . . . . . 7 02 .2 Identificationdataofthehandpiece . . . . . . . . . . . . . . . . . . . . . . . 7 02 .3 Identificationdataoftheinserts . . . . . . . . . . . . . . . . . . . . . . . . . . 703 ÛDELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 03 .1 ListofthecomponentsofthePIEZOSURGERY®touch . . . . . . . . . . 804 ÛINSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 04 .1 Firstinstallation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 04 .2 Safetyprecautionsduringtheinstallation . . . . . . . . . . . . . . . . . . 9 04 .3 Connectionoftheaccessories . . . . . . . . . . . . . . . . . . . . . . . . . . 10

05 Û USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 05 .1 Switchingthedeviceonandoff . . . . . . . . . . . . . . . . . . . . . . . . . 12 05 .2 Descriptionofthekeyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 05 .3 Safetyprecautionsbeforeandduringuse . . . . . . . . . . . . . . . . . . 16 05 .4 Instructionsforuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 05 .5 Importantinformationontheinserts . . . . . . . . . . . . . . . . . . . . . 20

06 ÛMAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

07 Û DISPOSAL MODES AND PRECAUTIONS . . . . . . . . . . . . . . . . . . 21

08 ÛTECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 08 .1 Electromagneticcompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . 23

09 ÛTROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 09 .1 Diagnosticsystemandsymbolsonthekeyboard . . . . . . . . . . . . 27 09 .2 Quicksolutiontoproblems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 09 .3 Replacementofthefuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

10 ÛLIMITED WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 10 .1 CustomerService-Returnsand/orRepairs . . . . . . . . . . . . . . . . . 32

2

01 Û INTRODUCTION

01.1 Û INTENDED USE OF THE PIEZOSURGERY® touch

Read this manual and follow its instructions carefully before proceeding with the installation, use, maintenance, or other operations on the device. Always keep this manual within easy reach. ThewordsWARNINGandCAUTION,containedinthisdocument,carryspecialmeaningsandmustbecarefullyreviewed.

WARNING: Implies that death or serious injury could occur if the advice is not followed.

CAUTION: Implies that minor injury or device damage could occur if the advice is not followed NOTE: Implies advice that is not related to harm.

IMPORTANT: toavoidpotentialseriousinjurytotheuserandthepatientand/orthisdeviceorotherequipments,readallthe“Safetyprecautions”presentinthemanualwith

particularattention.Thepurposeofthismanualistomaketheoperatorknowledgeableofthesafetyprecautions,theinstallationprocedures,andtheinstructionsforacorrectuseandmaintenanceofthedeviceanditsaccessories.Useofthismanualforpurposesotherthanthosestrictlytiedtotheinstallation,useandmaintenanceofthedeviceisforbidden.Theinformationandillustrationsinthismanualareupdatedasofthedateofissuereportedonthelastpage.ThemanufacturerMectronSpAiscommittedtocontinuouslyupdateitsproductswithpossiblemodificationstodevicecomponents.Incaseyouuncoverdiscrepanciesbetweenwhatisdescribedinthismanualandthedeviceinyourpossession,contactPiezosurgeryInc.forclarificationsandsupport.

ThePIEZOSURGERY®touchisapiezoelectricultrasonicdevice,consistingofhandpiece/sandassociatedinsertsintendedfor:-Bonecutting,osteotomy,osteoplastyand drillinginavarietyoforalsurgical

procedures,includingimplantology,periodontalsurgery,surgicalorthodonticsandsurgicalendodonticsprocedures;

Scalingapplicationsincluding:-Scaling:Allgeneralproceduresforremovalof supragingivalandinterdentalcalculus&

plaquedeposits;-Periodontology:Periodontaltherapyand

debridementforalltypesofperiodontal diseases,includingperiodontalpocket irrigationandcleaning;-Endodontics:Alltreatmentsforroot canalreaming,irrigation,revision,filling, gutta-perchacondensationandretrograde preparation;-RestorativeandProsthetics:Cavity preparation,removalofprostheses,

amalgamcondensation,finishingofcrownpreparationsandinlay/onlaycondensation.

WARNING: Qualified and specialized personnel. Thedevicemustbeusedexclusivelybyspecializedandappropriatelytrainedpersonnelsuchasalicenseddentistcompletelyfamiliarwiththerequiredtechniquesandinstructionsforuseoftheequipment.Theuseofthedevicedoesnotcausesideeffectsifitisusedcorrectly.Animproperusemightcausetissuesheating

WARNING: Usethedeviceonlyfortheintendeduse.Failuretoobservethisprecautionmaycauseseriousinjuriestothepatient,theoperator,anddamages/breakdownstothedevice.

3

01 Û INTRODUCTION

01.2 Û DESCRIPTION OF THE DEVICE

01.3 Û RESPONSIBILITY WAIVER

TheuserinterfacehasbeenoptimizedwiththePIEZOSURGERY®touchmakingallthefunctionsreadilyavailablebyintegratingtheminthetouchkeyboard.ThePIEZOSURGERY®touch isadevicethatusesultrasonicpiezoelectrictechnologytogeneratemechanicalmicrovibrationsoftheinserts,toeffectivelycutmineralizedtissues.Thisallowsanefficientandsafecuttingwhichpreservestheintegrityoftheosteotomizedsurfaces.

Themicrometric,ultrasonicvibrationsoftheinsertsprovidegreaterprecisionandaselectivecuttingactioncomparedtotraditionalmethodssuchasdrillsoroscillatingsaws(whichactwithmacrovibrations),thereforeminimizingtraumaticeffectonsofttissues.Thecavitationeffectoftheirrigatingsolutionhelpstokeeptheoperatoryfieldblood-free.Thisprovidesanoptimalintra-operatoryvisualcontrolthusincreasingsafety,eveninareasthatareanatomicallymostdifficulttoaccess.

ThemanufacturerMectronandtheimporterPiezosurgeryInc.disclaimanyliability,expressedorimplied,andshallhavenoresponsibilityforanydirect,indirectorotherdamagesandpersonalinjuryarisingoutinconnectionwithanyerrorsintheuseofthedeviceanditsaccessories.ThemanufacturerMectronandtheimporterPiezosurgeryInc.shallbeundernoliability,expressedorimplied,withrespecttoanydamages(personalinjuryand/ordamagetoproperty)whichmightariseorbecaused,whetherbythecustomerorbyanyoftheusersoftheproductanditsaccessories,asresultof:1 Useorproceduresdifferentthanthose

specifiedintheintendeduseoftheproduct;

2 TheenvironmentalconditionsforthepreservationandstorageofthedevicearenotcomplianttotheprecautionsindicatedintheChapter08-TECHNICALDATA;

3 Thedeviceisnotusedincompliancewithalltheinstructionsandprecautionsdescribedinthismanual;

4 Theelectricalsysteminthepremisesinwhichthedeviceisusedisnotcomplianttothenormsinforceandtotherelativeprecautions;

5 Theassemblyoperations,extensions,adjustments,updates,andrepairsonthedeviceareperformedbypersonnelnotauthorizedbyPiezosurgeryInc;

6 Improperuse,mistreatments,and/orincorrectinterventions;

7 Anyandallattemptstotamperwithormodifythedevice,underanycircumstance;

8 Useofnon-originalPiezosurgery/Mectroninsertsthatentailafinitedamagetothethreadingofthehandpeice,thuscompromisingcorrectoperationandcausingriskofharmtothepatient;

9 Useofnon-originalPiezosurgery/Mectroninserts,usedinaccordancetodesignedandtestedsettingsofPiezosurgery/Mectronoriginalinserts.ThecorrectuseofthesettingsisguaranteedonlywithoriginalPiezosurgery/Mectroninserts;

10 Lackofstockmaterials(handpiece,inserts,wrenches)tobeusedintheeventofdevicestopduetofaultorofinconveniences.

4

WARNING: Do not install the device in places where there is a risk of explosion.Thedevicecannotoperateinenvironmentswhereflammableatmospheresarepresent(anestheticmixtures,oxygen,etc.)

CAUTION: Inthecasethattheenduser,whenoperatinginhisorherownmedicalstudyorclinic,mustsubjecttheelectro-medicalequipmentandsystemstoperiodicalinspectionsinordertoadheretoimposedrequirements,thetestproceduresthatmustbeappliedtoelectro-medicalequipmentandsystemstoevaluatesafetymustbeperformedinlinewithstandardIEC62353‘RecurrentTestandTestafterrepairofmedicalelectricalequipment’.

WARNING: Checking device status before the treatment. Alwayscheckthatthereisnowaterunderneaththedevice.Beforeeverytreatment,alwayscheckthatthedeviceworksperfectlyandthattheaccessoriesareefficient.DONOTusethedeviceanditsaccessoriesifdamageisapparent.ContactPiezosurgeryInc.iftheabnormalitiesconcernthedevice.

CAUTION: Theelectricalsystemofthepremisesinwhichthedeviceisinstalledandusedmustbecomplianttothenormsinforceandtotherelativeelectricalsafetyprecautions.

CAUTION: Onlyconnecttheconsoletohospitalgradereceptaclestoensureelectricalgroundingreliability.Thisdevicemustbegrounded.

WARNING: DonotoperatethefootswitchofthePIEZOSURGERY®touchdevicewhenthepumpheadoftheperistalticpumpisopen.Movingpartscouldinjuretheoperator

WARNING: Control of infections.First UseThereusableaccessories(brandneworreturnedbyservice)andthesingle-

useaccessories(diamondcoatedinserts)aredeliveredinNON-STERILEconditionsandmustbepreparedpriortousebyapplyingtheproceduresdescribedintheCleaningandSterilizationmanualprovidedwiththedevice.Every useOnceused,eachreusableaccessorymustbethoroughlyreprocessedpriortoreuse,accordingtotheproceduresdescribedintheCleaningandSterilizationmanualprovidedwiththedevice.

WARNING: Breakage and wear-out of the inserts.Highfrequencyoscillationsandwear-outmay,inrarecircumstances,leadtothebreakageoftheinsert.Deformedorotherwisedamagedinsertsaresusceptibletobreakageduringtheiruse.Theseinsertsmustneverbeused.Shouldaninsertfracture,duringuse,checkthatnoneofitsfragmentsremaininthetreatedpartand,atthesametime,applyeffectivesuctiontoremovethem.Thepatientmustbeinstructedtobreathethroughhisnoseduringthetreatment,oradentaldammustbeusedtopreventthepatientfromingestingfragmentsofbrokeninserts.Whenthenitridecoatingwearsout,thecuttingefficiencydecreases;re-sharpeningtheinsertdamagesitandisthereforeforbidden.Checkthattheinsertisnotwornout.Useofaworn-outinsertreducesthecuttingperformanceandcancausenecrosisofthebonesurfacetreated.Duringtheintervention,frequentlycheckthattheinsertisintact,especiallyinitsapicalpart.Duringtheintervention,avoidprolongedcontactwithretractorsorwithmetallicinstrumentationinuse.Donotexertexcessivepressureontheinsertsduringtheiruse.

WARNING: Diamondcoatedinsertsareintendedforsingleuseonly.

01.4 Û SAFETY PRECAUTIONS

5

01 Û INTRODUCTION

WARNING: OnlyuseoriginalPiezosurgery/Mectroninserts,accessories,andspareparts.

ContraindicationsWARNING: Donotusethe

PIEZOSURGERY®touchonpatientswhocarryheartstimulators(Pace-makers)orotherimplantableelectronicdevices.Thisprecautionalsoappliestotheoperator.

WARNING: Interference from other equipment. Theuseofanelectricalscalpelorotherelectro-surgicalunit/snearthePIEZOSURGERY®touchmayinterferewithitscorrectfunctioning.

CAUTION: Donotperformtreatmentsonmetalorceramic/porcelainprostheticartifacts(unlessotherwisespecified).Theultrasonicvibrationcouldcausedecementation/looseningofsuchartifacts.

WARNING: Interference with other equipment.ThoughcomplianttothestandardIEC60601-1-2,thePIEZOSURGERY®touchmaynonethelessinterferewithotherdevicesnearby.ThePIEZOSURGERY®touchmustnotbeusedneartoorstackedonotherdevices.Ifadjacentorstackeduseisnecessary,thePIEZOSURGERY®touchandtheotherdevicesmustbeobservedandcheckedtoverifynormaloperationintheconfigurationinwhichtheywillbeused.

CAUTION: Allowreusable,autoclavableitemstograduallyreturntoroomtemperatureaftersteamsterilizationandpriortousage.Thecoolingprocessmustnotbeaccelerated.

CAUTION: Nomodificationofthisequipmentisallowed.

6

01.5 Û SYMBOLSSerialnumber

Lotnumber

Productcode

Warning:readtheinstructionsforuse

Operatinginstructions

Temperaturelimitation-transportandstorageconditions

Humiditylimitation-transportandstorageconditions

Atmosphericpressurelimitation-transportandstorageconditions

ItindicatescompliancewiththeCE93/42CEEEN60601-1andEN60601-1-2.Notifiedbody:CERMET.

METMarkUL-CSAconformity

Manufacturer

Donotallowfingerstocontactmovingparts

QTY.1 Quantityofpartsinthepack=1

Single-use

Appliedpartoftype“B”aspernormEN60601-1

Canbesterilizedinautoclaveuptoamaximumtemperatureof135°C

Non-sterile

Thedeviceanditsaccessoriesmustnotbedisposedofortreatedassolidurbanwastes

Biohazard

I Activationswitch“on”

0 Activationswitch“off”

Alternatingcurrent

Connectionofthefootpedal

Equi-potentiality

ForUSmarketonly RxOnly CAUTION USFederalLawrestrictsthisdevicetosalebyorontheorder ofadentist

-10 °C

70 °C

10 %

90 %

1060 hPa

500 hPa

7

02 Û IDENTIFICATION DATA

02 Û IDENTIFICATION DATA

Everydevicehasanidentificationplatethatbearsthetechnicalcharacteristicsandtheserialnumber.Theidentificationplateislocatedontheinferiorpanelofthedevice.Additionalspecificationsarereportedinthismanual(SeeChapter08 - TECHNICAL DATA).

Eachhandpieceislaser-markedwithitsserialnumber(ref.1),andMectronandPIEZOSURGERY®touchlogos(ref.2).

Thefollowingdataarelaser-markedoneachinsert:thenameoftheinsert(ref.3),theMectronlogo(ref.4)andthelotnumbertowhichtheinsertbelongs(ref.5).

02.1 Û IDENTIFICATION PLATE OF THE DEVICE

02.2 Û IDENTIFICATION DATA OF THE HANDPIECE

02.3 Û IDENTIFICATION DATA OF THE INSERTS

OT7

AA/XXX

XX

3 4 5

ManufacturerMectron S.p.A.Via Loreto 15/A16042 Carasco -GE- Italy

409000000 made in Italy

PIEZOSURGERY TOUCHDENTAL UNIT100-240 V~ 120 VA - 50/60 Hz.Intermittent operation UL 60601-1 CSA C22.2

No. 601-1 - E113015

Rx

Onl

y0476

1 2

AnexactdescriptionofthemodelandoftheserialnumberofthedevicewillenableourAfter-SalesServicetoprovidefastandefficientsupport.AlwaysreferthesedatawheneveryoucontactPiezosurgeryInc.’sService.

8

03 Û DELIVERY

03.1 Û LIST OF THE COMPONENTS OF THE PIEZOSURGERY® touch Seeinsidecover PIEZOSURGERY®touchsystemconsistsof:A devicebodyB peristalticpumpC irrigationbagsupportrodD PIEZOSURGERY®touch handpiecefixedsupportE PIEZOSURGERY®touch handpiecemobilesupportF manualofuseandmaintenanceandmanualofcleaningandsterilizationG electricalpowersupplycableH footpedalwithbracket,cordandconnectorI back-upfootpedalJ handpiececompletewithcordandfrontterminalwithoutlight

CAUTIONthehandpieceandthecordcannotbeseparated

K inserts/insertkitL torquewrenchM peristalticpumptubingkit(Thekitiscomposedbyasetof6peristalticpumptubing)N bonegraftingkit(optional)O case

ThePIEZOSURGERY®touchconsistsofaccessoriesthatcanbeorderedseparately.Refertothe“PackingList”includedinyourpackage,sothatyoumayexactlyknowthequantityandtypeoftheaccessoriessuppliedwiththedeviceyouhavepurchased.Thepackageofthedeviceissensitivetostrongcollisions,becauseitcontainselectroniccomponents.Therefore,specialprecautionsmustbetakenfortransportandstorage.Donotoverlapmultipleboxes,inordernottosquashthepackagesunderneath.AllthematerialsshippedbyPiezosurgeryInc.havebeeninspectedupontheirdelivery.Thedeviceisdelivereddulyprotectedandpacked.Whenreceivingthedevice,checkforthepossiblepresenceofdamagesincurredduringthetransport.

WARNING:Carefullyunpackthedeviceandcheckifanydamageoccurredduringshipment.Iftheshippingpackagingisdamagedortheprotectivematerialshowssignsofstress,DONOTUSEthedeviceandfileacomplaintwiththetransporter.Keeptheshippingmaterialforcarrierinspection.

Keeptheoriginalpackaginguntilthedeviceistobedisposedofpermanentely.Packtheequipmentinitsoriginalpackagingduringprolongedperiodsofdisuse.ShouldthePIEZOSURGERY®touchequipmentneedservicingorrepair,returnittothePiezosurgeryInc.CustomerServiceintheoriginalpackaging.

WARNING:Beforestartingtooperatewiththedevice,makesurethatyouhavestockmaterial(handpiece,inserts,wrenches)availabletouseincasethedevicestopsduetoafaultorofinconveniences.

9

04 Û INSTALLATION

04 Û INSTALLATION

04.2 Û SAFETY PRECAUTIONS DURING INSTALLATION WARNING: Interference with

other equipment.ThoughcompliantwiththestandardIEC60601-1-2,thePIEZOSURGERY®touchmaynonethelessinterferewithotherdevicesnearby.ThePIEZOSURGERY®touchmustnotbeusedneartoorstackedonotherdevices.Ifadjacentorstackeduseisnecessary,thePIEZOSURGERY®touchandtheotherdevicesmustbeobservedandcheckedtoverifynormaloperationintheconfigurationinwhichtheywillbeused.

WARNING: Interference from other equipment.Theuseofanelectricalscalpelorotherelectro-surgicalunit/snearthePIEZOSURGERY®touchmayinterferewithitscorrectfunctioning.

WARNING:Theelectricalsystemofthepremisesinwhichthedeviceisinstalledandusedmustbecomplianttothenormsinforceandtotherelativeelectricalsafetyprecautions.

CAUTION: Onlyconnecttheconsoletohospitalgradereceptaclestoensureelectricalgroundingreliability.Thisdevicemustbegrounded.

WARNING:Do not install the device in places where there is a risk of explosion.Thedevicecannotoperateinenvironmentswhereflammableatmospheresarepresent(anestheticmixtures,oxygen,etc.)

WARNING: DonotoperatethefootswitchofthePIEZOSURGERY®touchdevicewhentheperistalticpumpcoverisopen.Movingpartscouldinjuretheoperator.

WARNING:Installthedeviceinaplaceprotectedagainstcollisionsoragainstaccidentalspraysofwaterorliquids.

WARNING: Donotinstallthedeviceaboveornearheatsources.Foreseeadequateaircirculationaroundthedevicewheninstallingit.Leaveadequatespace,especiallynearthefanplacedonthebackpartofthedevice.

CAUTION:DonotexposethedevicetodirectsunlightortosourcesofUVlight.

CAUTION: Thedevicecanbetransported,butitmustbehandledwithcarewhenmoved.Positionthefootpedalonground,sothatitcanonlybeactivatedintentionallybytheoperator.

CAUTION:Beforeconnectingthehandpiececordtothedevice,makesurethattheelectricalcontactsareperfectlydry.Ifneedbe,drythemwithcompressedair.

04.1 Û FIRST INSTALLATIONThedevicemustbeinstalledinacomfortableplacesuitableforitsuse.

Placetheconsoleonasturdy,flat,dryandhorizontalsurface.

10

WiththewritingUPfacingupward,inserttheconnectorofthehandpiececordintothehandpiecereceptacleonthePIEZOSURGERY®touch console;

Inserttheperistalticpumptubingintheperistalticpump,proceedingasfollows:- openthepumpcovercompletely;

04.3 Û CONNECTION OF THE ACCESSORIES1

2

3

4

5

Inserttheirrigationbagsupportrodinthededicatedhole;

InsertthehandpiecefixedsupportinthehousingNOTEThehandpiecesupportcanbeplacedin4differentlocations:lateralright,frontright,frontleft,lateralleft;

Inserttheperistalticpumptubing,suppliedwiththedevice,intotheconnectorofthehandpiececord;

CAUTION: UseoriginalPiezosurgery/Mectronperistalticpumptubingonly,asdamageorsubstandardperformancecouldresult.

11

04 Û INSTALLATION

Connecttheperistalticpumptubingtotheflowadjuster(notsupplied);

Connecttheflowadjuster(notsupplied)totheliquidbagusedforthetreatment(bagnotsupplied).Hangthebagtoitsspecificsupportrod;

7

6

8

9

NOTE Thefootpedalcomesequippedwithabracketthatallowsittobemovedtotheplacemostsuitablefortheoperation,withouttheneedtouseyourhandstomoveit.

Thebracketcanalsobepositionedhorizontallyifitisnotused.

Connectthefootpedaltothebackofthedeviceinthesocketmarkedwiththesymbolbymeansoftheplugofthepedalcable,untilyouheara“click”sound;

- Insertthetubingbyplacingitoverthepumprollers;

- closethepumpcovercompletely;

WARNING: DonotoperatethefootswitchofthePIEZOSURGERY®touchdevicewhentheperistalticpumpcoverisopen.Movingpartscouldinjuretheoperator.

12

11

05 Û USE

Turning the device onFacingthefrontoftheconsole,setthepowerswitchontheleftsidetothe“I”position,takingcarenottopressthefootpedal.Theconsolewillswitchonandfoursymbols(ref.Tinsidethecover)aretemporarilydisplayedonthetouchkeyboardandthenturnedoff.Atthispoint,thedevicesetsonthedefaultfactorysettingsanditisreadytooperate

Turning the device offFacingthefrontoftheconsole,turntheswitchontheleftsidetothe“O”position,takingcarenottopressthefootpedal.Theconsoleturnsoff.

05.1 Û SWITCHING THE DEVICE ON AND OFF

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Equipotentialplug:Thedeviceisequippedwithanadditionalequipotentialpluglocatedontherearoftheconsole.ThisplugisinaccordancewithDIN42801.Inserttheconnectoroftheequipotentialcord(optional)totheplugontherearofthedevice’sconsole.Thepurposeofadditionalpotentialequalizationistoreducedifferencesofpotentialwhichcanoccurduringoperationbetweenthedevice’sbodyandconductivepartsofotherobjectswithinthemedicalenvironment.

10Connectthepowersupplycordintothereceptacleonthebackoftheconsole.Connectitonlytohospitalgradereceptacles;

PLEASE NOTE WhenthePIEZOSURGERY®touchisswitchedon,thefollowingoperationalmodesareset:“function”ENDO,“irrigation”3,“light”OFF.

13

05 Û USE

Touch keyboard Theusercanconfigurethedevicebysimplytouchingonthetouchkeyboard.Dependingontheselectedsetting,theelectronicfeedbacksystemautomaticallyadjuststhecorrectoperatingfrequency.

05.2 Û DESCRIPTION OF THE KEYBOARD

FUNCTIONS (ref. Q inside cover)Dependingonthetypeofclinicalapplication,itispossibletochooseoneofthe6optionsavailablefromthe“function”list:ENDO:dedicatedtoendodonticsurgery,toSchneider’smembranedetachmentandconventionalendodontictreatmentsPERIO:dedicatedtoperiodontalsurgeryandconventionalscalingandperiodontaltreatmentsSPECIAL:dedicatedonlytotheinsertsforosteotomieswiththicknessesof0 .35mmandforprostheticapplicationsCANCELLOUS:dedicatedtothecuttingandremovalofpoorlymineralizedboneCORTICAL:dedicatedtothecuttingandremovalofhighlymineralizedboneIMPLANT:dedicatedtoboneperforationinthetechniqueoftheimplantsitepreparation

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FILLING AND FLUSHING THE IRRIGATION CIRCUIT (ref. S inside cover)Thedeviceisequippedwiththe“pump/flush”keywhich,dependingonthemodeofuse,allowstoperformthePUMPfunctionortheFLUSHfunction.ThePUMPfunctioncanbeusedatthebeginningofthetreatment,toflushtheentireirrigationlineuptotheinsert,sothatthesurgerycanbestartedwiththenecessaryirrigation(seeparagraph05 .4).TheFLUSHfunctionallowstorunaflushingcycleoftheirrigationcircuitofthehandpiece(s)usedduringthetreatment.

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CAUTION:TheFLUSHfunctionmustbeusedaftereverypatienttreatment,beforestartingthecleaningandsterilizationprocedures.Failuretocarryoutflushingofthehandpiecetubingwillleadtosaltcrystallisationthatcanseriouslydamagethedevice

WARNING: The“FLUSH”functiondoesnotsubstituteforthecleaningandsterilization

proceduresdescribedintheCleaningandSterilizationmanual.Afterhavingcarriedoutthe“FLUSH”function,thecleaningandsterilizationproceduresmustbefollowedmeticulouslyinordertopreparethedeviceaccessoriesreadyforthenextpatientandminimizeanyriskofpatient-to-patientcontamination.

14

Intheeventthatanirrigationcapacitylowerthan8ml/minisrequired,usethe“bonegraftingkit”(accessorythatcanbeorderedseparately),insertingitbetweentheflowadjusterandthetubeinsiliconofthehandpiece,makingitpassthroughtheperistalticpump,andselecting1asthelevelofirrigation.

0

1

2

3

4

5

6


implant

cortical

cancellous

endo

perio

special

auto

on

off

pump/clean

IRRIGATION (ref. P inside cover)Theirrigationflowratecanbeadjustedbyselectingthenumbersonthetouchkeyboardinthe“irrigation”column.7capacitylevelsareforeseen:0=operationofthepumpisclosed:noirrigationoutflowsfromtheinsertFrom1to6=thepumpflowgoesfrom8ml/mintoapproximately75ml/min.Thepossibilityofchoosingtheirrigationcapacitylevelsistiedtothetypeoffunctionselected,inthefollowingmanner:ENDO-7flowlevels:from0to6(from0toapproximately75ml/min)PERIO-7flowlevels:from0to6(from0toapproximately75ml/min)SPECIAL-6flowlevels:from1to6(from8toapproximately75ml/min)CANCELLOUS-6flowlevels:from1to6(from8toapproximately75ml/min)CORTICAL-6flowlevels:from1to6(from8toapproximately75ml/min)IMPLANT-6flowlevels:from1to6(from8toapproximately75ml/min)

NOTEtreatmentwithoutirrigationispossibleonlywiththeENDOandPERIOfunctions,settingtheirrigationcapacitylevelon“0”.

WARNING:Ifthe“bonegraftingkit”tubeiskeptinsertedfortheentiredurationoftheintervention,thecapacityofthepumponallitslevelsislimited,independentlyofwhichinsertisused.

��

OPTIONAL

15

05 Û USELIGHT (ref. R inside cover)Dependingonthetypeofhandpieceandoperationthatneedstobeperformed,itispossibletochoose3optionsfromthe“light”list:•BychoosingtheAUTOoption,theLEDlight

onthefrontterminalofthehandpieceisswitchedonbypressingthefootpedal,andautomaticallyswitchesoff3secondsafterthepedalisreleased.

•BychoosingtheONoption,theLEDlightonthefrontterminalofthehandpiecestaysonpermanently,regardlessofwhetherpressureisappliedonthefootpedalornot.Thelightswitchesoff100secondsafterthelastpressureofthefootpedalandtheoptionshiftsfromONtoAUTO.

•BychoosingtheOFFoption,theLEDlightonthefrontterminalofthehandpiecestaysoffpermanently.

ThepositionoftheLEDlightonthefrontterminalofthehandpiececanbeadjustedinthefollowingway:•Holdthebodyofthehandpieceandlightly

unscrewthemetalringnutlocatedatthebaseofthefrontterminal,rotatingitcounter-clockwise.

•RotatethefrontterminalsothattheLEDlightgoesintothedesiredandnecessaryposition.

•Tofastenitintoposition,screwthemetalringnut,rotatingitclockwise.

��

SYMBOLS (ref. T inside cover)ThePIEZOSURGERY®touchisequippedwithadiagnosticcircuitthatallowstodetectoperatingabnormalitiesandtoviewtheirtypeonthekeyboardviatheirrelativesymbol.Tohelptheuseridentifythemalfunctioningpart,foursymbolsareforeseenwhicharedescribedinparagraph09.1.0

1

2

3

4

5

6

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16

05.3 Û SAFETY PRECAUTIONS BEFORE AND DURING USEWARNING: Beforestartingtooperate

withthedevice,makesurethatyouhavestockmaterial(handpiece,inserts,wrenches)availabletouseincasethedevicestopsduetoafaultorofinconveniences.

CAUTION: Contra-indication. Donotperformtreatmentsonmetalorceramic/porcelainprostheticartifacts.(unlessotherwisespecified).Theultrasonicvibrationcouldcausedecementation/looseningofsuchartifacts.

WARNING: Contra-indications.DonotusethePIEZOSURGERY®touchonpatientswhocarryheartstimulators(Pace-makers)orotherimplantableelectronicdevices.Thisprecautionalsoappliestotheoperator.

WARNING: Checking device status before the treatment. Alwayscheckthatthereisnowaterunderneaththedevice.Beforeeverytreatment,alwayscheckthatthedeviceworksperfectlyandthattheaccessoriesareefficient.DONOTusethedeviceanditsaccessoriesifdamageisapparent.ContactPiezosurgeryInc.iftheabnormalitiesconcernthedevice.

CAUTION: FLUSH function. Afterthedeviceisusedwithaggressiveandnon-aggressivesolutions,itisnecessarytoperformaflushingcycleonthetubesandthehandpiecewiththeFLUSHfunction(seeCleaningandSterilizationManual).Ifthetubesarenotcleaned,thecrystallizationofthesaltsmayseriouslydamagethedevice.

CAUTION: Allowreusable,autoclavableitemstograduallyreturntoroomtemperatureaftersteamsterilizationandpriortousage.Thecoolingprocessmustnotbeaccelerated.

WARNING: Control of infections.First UseThereusableaccessories(brand

neworreturnedbyservice)andthesingle-useaccessories(diamondcoatedinserts)aredeliveredinNON-STERILEconditionsandmustbepreparedpriortousebyapplyingtheproceduresdescribedintheCleaningandSterilizationmanualprovidedwiththedevice.Every useOnceused,eachreusableaccessorymustbethoroughlyreprocessedpriortoreuse,accordingtotheproceduresdescribedintheCleaningandSterilizationmanualprovidedwiththedevice.

CAUTION: The electrical contacts inside the cord connector must be dry.Beforeconnectingthehandpiecetothedevice,makesurethattheelectricalcontactsoftheconnectorareperfectlydry,especiallyafterthesterilizationcycleinautoclave.Ifneedbe,drythecontactsbyblowingcompressedairontothem.

CAUTION: FLUSH function.TheFLUSHfunctionmustbeusedaftereverytreatment,beforestartingthecleaningandsterilizationprocedures.

WARNING: Toprovideadequatecoolingforthehandpiece,alwaysactivateitwiththeirrigationcircuitcorrectlyinstalledandfilled.Tofilltheirrigationcircuit,alwaysusethePUMPfunction

WARNING: Treatments that require irrigation. Alwayscheckoperationoftheirrigationbeforeandduringuse.Makesurethefluidoutflowsfromtheinsert.Donotusethedeviceiftheirrigationdoesnotworkorifthepumpisdefective.

WARNING: Only use original Piezosurgery/Mectron inserts, accessories, and spare parts.

WARNING: Use of non-original Piezosurgery/Mectron inserts: thisuseentailsfinitedamagetothehandpiecethreading,thuscompromisingcorrectoperationandriskingtocauseharmtothepatient.

17

05 Û USE

CAUTION:Donotactivatethehandpiecewhiletheinsertisincontactwiththeparttobetreated.Doingso,willnotallowtheelectroniccontrolcircuitoftheconsoletorecognizethebestpointofresonanceoftheinsert,requiredforefficientandoptimumperformance.

WARNING:Beforeeverytreatment,makesurethattheinsertappropriateforthetreatmentisinsertedonthehandpiece.ExclusivelyusetheoriginalPiezosurgery/Mectrontorquewrenchtofastentheinserttothehandpiece.

WARNING:Thepatientmustnotcomeintocontactwiththedevicebodyorthefootpedal.

WARNING:Donotchangetheinsertwithhandpiecerunning,topreventcausingwoundstotheoperator.

WARNING: Breakage and wear-out of the inserts. Highfrequencyoscillationsandwear-outmay,inrarecircumstances,leadtothebreakageoftheinsert.Donotbend,changeshapeof,orre-sharpenaninsertinanyway.Bendinganinsertorapplyingleverageonitcanleadtoitsbreakage.

Deformedorotherwisedamagedinsertsaresusceptibletobreakageduringtheiruse.Theseinsertsmustneverbeused.Excessivepressureappliedtoinsertduringitsusecancauseinsertfracture.Shouldaninsertfractureduringuse,checkthatnoneofitsfragmentsremaininthetreatedpartand,atthesametime,applyeffectivesuctiontoremovethem.Thepatientmustbeinstructedtobreathethroughhisnoseduringthetreatment,oradentaldammustbeusedtopreventthepatientfromingestingfragmentsofbrokeninserts.Whenthenitridecoatingwearsout,thecuttingefficiencydecreases;re-sharpeningtheinsertdamagesitandisthereforeforbidden.Priortoeachusecheckthattheinsertisnotwornout.Useofaworn-outinsertreducesthecuttingperformanceandcancausenecrosisofthebonesurfacetreated.Duringtheintervention,frequentlycheckthattheinsertisintact,especiallyitstop.Duringtheintervention,avoidprolongedcontactwithretractorsorwithmetallicinstrumentationinuse.

05.4 Û INSTRUCTIONS FOR USE

Openboththeairsocketontheflowadjusterandtheliquidpassage1

AfterhavingconnectedalltheaccessoriesasillustratedinParagraph04.3,proceedasfollows:

18

Tofilltheirrigationcircuit,usethePUMPfunctionbyselectingPUMP/FLUSHonthetouchkeyboard:alltheotherselectionoptionspresentonthedisplayaredisabled,andthePUMP/FLUSHwritingflashes

WhilethePUMP/FLUSHwordingisflashing,pressthefootpedalonceandreleaseit;thePUMP/FLUSHstopsflashingandtheirrigationcircuitstartstofillup

2

3

4

0

1

2

3

4

5

6

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��

��

��

��

��

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Assoonastheperistalticpumpstarts,theentirescaleofvaluesofthe“irrigation”sectionlightsupandduringtheliquidpassage,thevalueoftheirrigationshiftsfrom6to0

5ThecyclecanbeinterruptedassoonyouseeliquidoutflowingfromthePIEZOSURGERY®touchhandpiece,bypressingPUMP/FLUSHagainor,alternatively,bypressingthefootpedal.ThePUMPfunctionisdisabledandthekeyboardisenabledagain,anddisplaysthelastsettingused

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6ScrewthechoseninsertontothePIEZOSURGERY®touchhandpiece,untilitreachesthelimitstop

19

05 Û USE

10 Onthekeyboard,selectthetypeoffunctionandirrigationnecessaryandthelight,ifdesired

CAUTION:ForthecorrectsettingoftheFunctionparameterswiththespecificinsertyouwishtouse,consulttheChartannexedtothismanualtitled“AppropriatesettingsfortheinsertsonthePIEZOSURGERY®touch”ortheillustrativeleafletoftheMectroninsertyou’vepurchased.

7

8

9

TightentheinsertbyusingthePiezosurgery/Mectrontorquewrench.TocorrectlyusethePiezosurgery/Mectrontorquewrench,operateasfollows:

Puttheinsertinsidethewrenchasshown

Firmlyholdthecentralbodyofthehandpiece

CAUTION:Thehandpiecemustnotbegrabbedbyitsterminalpartand/orcord,butonlybyitscentralbody.Thehandpiecemustnotberotated,butmustbegraspedfirmly,andyoumustonlyrotatethewrench.

Rotatethewrenchclockwiseuntilthefrictionsnaps(theexternalbodyofthewrenchrotatescomparedtothehandpiece,emittingmechanical“CLICK”sounds).Theinsertisnowperfectlytightened

��

CORRECT

NOTCORRECT

20

WARNING: Diamond coated insertsDiamondcoatedinsertsareSINGLEUSE.Thediamondcoatedinsertsareintendedtobeusedonanindividualpatientduringasinglesurgicalprocedureandthendiscar-ded.Thediamondcoatedinsertscannotthere-forebereprocessedsincetheycannotbecleanedproperly.Boneandsoilresiduesmightremainadheredtothediamondcoatingevenafetrcleaningandsterilizationandenterintotheoralcavityofanotherpatient

WARNING:- Whenthetitaniumnitridecoating

isvisiblywornout,theinsertmustbereplaced.Useofawornoutinsertreducesitscuttingefficiency.

- Donotactivatethehandpiecewhiletheinsertisincontactwiththeparttobetreated.Doingso,willnotallowtheelectroniccontrolcircuitoftheconsoletorecognizethebestpointofresonanceoftheinsert,requiredforefficientandoptimumperformance.

- Checktheconditionofwearoftheinsertandthatitisintactbeforeandduringeveryuse.Ifadamageordropinperformanceisnotedreplaceitwithanewone.

-UseoriginalPiezosurgery/Mectroninsertsonly.Useofnon-originalinserts,inadditiontovoidingthewarranty,damagesthethreadingofthePIEZOSURGERY®touchhandpiece,withtheriskofnolongerbeingabletoscrew

theoriginalinsertscorrectlyduringsubsequentuse.Moreover,thedevicesettingsaretestedandguaranteedtooperatecorrectlyonlywhenoriginalPiezosurgery/Mectroninsertsareused.

- Donotchangetheshapeoftheinsertinanywaybyeitherbendingorfilingit.Thiscouldcauseittobreak.

- Donotuseaninsertthathassufferedanytypeofdeformation.

- Donotattempttosharpentheinsertused.

- Alwayscheckthatthethreadedpartsoftheinsertandofthehandpieceareperfectlyclean–seetheCleaningandSterilizationManual.

- Ifexcessivepressureisappliedontheinsert,itcancausetheinserttobreakandpossiblyharmthepatient.

-Forinformationonhowtocorrectlyusetheinserts,consulttheannexedsheet“AppropriatesettingsfortheinsertsonthePIEZOSURGERY®touch”ortheillustrativeleafletprovidedwiththePiezosurgery/Mectroninsertyou’vepurchased.

- BeforeusingthePIEZOSURGERY®touch,makesureyouhavepreparedtheoperatorysitebyhavingfirstmovedawaythesofttissues,toavoiddamagingthem.Itmayhappenthat,whilecuttingthebone,accidentalcontactofcertainpartsoftheinsertwiththesofttissuesinflictssmalltraumas.Tominimizethisrisk,usespecificprotectiveinstruments.

05.5 Û IMPORTANT INFORMATION ON THE INSERTS

21

06 Û MAINTENANCE

06 Û MAINTENANCE

07 Û DISPOSAL MODES AND PRECAUTIONS

Ifthedeviceisnotusedforprolongedtime,observethefollowingrecommendations:1 Runacompleteflushingcycleonthe

irrigationcircuitwiththeFLUSHfunction(seetheCleaningandSterilizationManual)

2 Disconnectthedevicefromtheelectricalnetwork

3 Iftheperiodofdisuseisprolonged,putthedevicebackinitsoriginalpackageandstoreitinasafeplace

4 Priortousingthedeviceagain,cleanandsterilizethehandpiece,theinserts,the

wrench,thetubes,andtheconnectors,followingtheinstructionsprovidedintheCleaningandSterilizationManual.

5Checkthattheinsertsarenotwornout,deformed,orbroken,placingspecialattentiontotheintegrityoftheirtip

WARNING: Periodicallycheckthattheelectricalpowercableisintact;ifitisdamaged,replaceitwithanoriginalPiezosurgery/Mectronsparepart.

WARNING: Hospital wastes.Hospitalwastes.Treatthefollowingitemsashospitalwaste:- Inserts:whentheyarewornoutor

broken;- Flowadjuster:attheendofeach

intervention;- Peristalticpumptube:after8sterilization

cycles;- Torquewrenchforinserts:whenworn

outorbroken.

Dischargingofbiohazardand/ornon-reusablematerialsmustbedonefollowinglocalandfederalregulationsforproperdisposalofcantaminatedmaterials.

22

08 Û TECHNICAL DATA

Device compliant to Dir. 93/42/CEE: ClassIIa

Classification as per EN 60601-1: I TypeB(Appliedparts:handpieceandinserts) IP20(device) IPX8(footpedal)

Device for intermittent operation: 60sec.ON-30sec.OFFwithirrigation 30sec.ON-120sec.OFFwithoutirrigation(ENDO,PERIO)

Power supply voltage: 100-240Vac50/60Hz

Max. power absorbed: 120VA

Fuses: Type5x20mm T2AL,250V

Operating frequency: Automaticscan From24KHzto36KHz

Power types: ENDO PERIO SPECIAL CANCELLOUS CORTICAL IMPLANT

Peristaltic pump capacity:Adjustableonthetouchscreen: ENDO/PERIO-7flowlevels:from0to6 (from0toapproximately75ml/min) SPECIAL/CANCELLOUS/CORTICAL/IMPLANT 6capacitylevels:from1to6 (from8toapproximately75ml/min)

LED system of the handpiece: LightfunctiononAUTO:LEDsystemofthehandpiece switchesonassoonasthedevicestartstooperate andswitchesoff3secondsafterthefootpedalis released LightfunctiononON:TheLEDofthehandpieceisalwayson;after100secondsoffootpedaldisuseit switchesoffbyitselfandthelightfunctionmovesinto positionAUTO LightFunctiononOFF:TheLEDofthehandpieceisalwaysoff.

Protections of the APC circuit:Nohandpiecedetected Cordinterruption Insertnottightenedcorrectlyorbroken

Operating conditions: from+10°Cto+40°C Relativehumidityfrom30%to75%

Transport and storage conditions: from-10°Cto+70°C Relativehumidityfrom10%to90% PressureofairP:500hPa/1060hPa

Peristaltic pump tube: Itisadvisablenottoexceed8sterilizationcycles

Weights and sizes: 3,2Kg L-l-h300x235x95mm

23


Guidance and manufacturer’s declaration - Electromagnetic emissions

ThePIEZOSURGERY®touchisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomeroruserofthePIEZOSURGERY®touchshouldensurethatitisusedinsuchanenvironment.

Emissions test

RFemissionsCISPR11

RFemissionsCISPR11

HarmonicemissionsIEC61000-3-2

Voltagefluctuations/flickeremissionsIEC61000-3-3

Compliance

Group1

ClassB

ClassA

Complies

Electromagnetic environment – Guidance

ThePIEZOSURGERY®touchonlyusesRFenergyforinternalfunction.Therefore,itsFRemissionsareverylowandarenotlikelytocauseanyinterferencewithnearbyelectronicequipment.

ThePIEZOSURGERY®touchissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

WARNING: Interference with other equipment.ThoughcompliantwiththestandardIEC60601-1-2,thePIEZOSURGERY®touchmaynonethelessinterferewithotherdevicesnearby.ThePIEZOSURGERY®touchmustnotbeusedneartoorstackedonotherdevices.Ifadjacentorstackeduseisnecessary,thePIEZOSURGERY®touchandtheotherdevicesmustbeobservedandcheckedtoverifynormaloperationintheconfigurationinwhichtheywillbeused.

WARNING:Portableandmobileradiocommunicationappliancesmayaffectthecorrectfunctioningofthedevice.

WARNING: Interference from other equipment.Theuseofanelectricalscalpelorotherelectro-surgicalunit/snearthePIEZOSURGERY®touchmayinterferewithitscorrectfunctioning.

WARNING:ThedevicerequiresspecificEMCprecautionsandmustbeinstalledandactivatedinaccordancewiththeEMCinformationgiveninthisparagraph.

08.1 Û ELECTROMAGNETIC COMPATIBILITY EN 60601-1-2

24

Guidance and manufacturer’s declaration - Electromagnetic immunity


Immunity test

Electrostaticdischarge(ESD)IEC61000-4-2

Electricalfasttransient/burstIEC61000-4-4

Powerfrequency(50/60Hz)magneticfieldIEC61000-4-8

N.B.:UtistheACmainsvoltagepriortoapplicationofthetestlevel.

SurgeIEC61000-4-5

Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlinesIEC61000-4-11

Test levelIEC 60601

±6kVcontact±8kVair

±2kVforpowersupplylines

±1kVforinput/outputlines

3A/m

±1kVdifferentialmode

±2kVcommonmode

<5%Ut(>95%dipinUt)for0,5cycles

40%Ut(60%dipinUt)for5cycles

70%Ut(30%dipinUt)for25cycles

<5%Ut

(>95%dipinUt)for5s

Electromagnetic environment - Guidance

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinacommercialorhospitalenvironment.



Compliance level

Thedevicecontinuestoworkregularlyandinsafety




Thedevicecanvaryfromtherequiredlevelsofimmunitywithadurationof<5% / >95% / 5saslongasthedeviceremainsinsafety,nomalfunctionshavebeendectedandcanberestoredtopre-teststatuswiththeinterventionoftheoperator

25


Guidance and manufacturer’s declaration - Electromagnetic immunity


Immunity test

ConductedRFIEC61000-4-6

RadiatedRFIEC61000-4-3

N.B.:(1) at80MHzand800MHz,thehigherfrequencyrangeapplies.(2)Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionand

reflectionfromstructures,objectsandpeople.a Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandland

mobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithanyreasonableaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichthePIEZOSURGERY®touchisusedexceedstheapplicableRFcompliancelevelgivenabove,thePIEZOSURGERY®touchshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientingorrelocatingthePIEZOSURGERY®touch.

b Overthefrequencyrangefrom150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

Test levelIEC 60601

3Vefffrom150kHzto80MHz

3V/mfrom80MHzto2,5GHz

Electromagnetic environment Guidance

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartofthedeviceincludingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.

Recommendedseparationdistanced=1,2√P

d=1,2√Pfrom80MHzto800MHzd=2,3√Pfrom800MHzto2,5GHz

where P isthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmetres(m).FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurveya,maybelessthanthecompliancelevelineachfrequencyrangeb.Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

Compliance level


26

Recommended separation distances between portable and mobile RF communications equipment and the PIEZOSURGERY® touch

ThePIEZOSURGERY®touchisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomeroruserofthePIEZOSURGERY®touchcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileFRcommunicationsequipment(transmitters)andthePIEZOSURGERY®touchasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Rated maximum output power of transmitter

‘W’

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmetres(m)canbecalculatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.N.B.:(1) at80MHzand800MHz,thehigherfrequencyrangeapplies.(2)Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionand

reflectionfromstructures,objectsandpeople.

from 150 kHz to 80 MHzd=1,2√P

from 800 MHz to 2,5 GHzd=2,3√P

Separation distance according to the frequency of transmitter ‘m’

from 80 MHz to 800 MHzd=1,2√P

27

09 Û TROUBLESHOOTING


09.1 Û DIAGNOSTIC SYSTEM AND SYMBOLS ON KEYBOARD

Symbols on keyboard Possible cause Solution

Handpiececordcontactswet

Insertnottightenedcorrectlyonhandpiece

Thoroughlydrythecontactswithcompressedair

UnscrewtheinsertandcorrectlyscrewitonagainwiththePiezosurgery/Mectrontorquewrench(seeparagraph05.4)

PIEZOSURGERY®touch handpiecenotconnectedtodevice

Peristalticpumpmalfunction

Insertbroken,worn-outordeformed

Handpiecedefective

Handpiececordcontactswet

Connectthehandpiece

Checkthattherearenoimpedimentstopumprotation

Replacetheinsert

Replacethehandpiece

Thoroughlydrythecontactswithcompressedair

Synccircuitmalfunction

Silicontubingnotpositionedcorrectlyinsidethepump

ContactPiezosurgeryInc.’sService

Correctlyrepositionthesilicontubinginsidethepump(seeparagraph04.3)

Thedevicehasbeenturnedoffandonagainwithoutwaiting5seconds

Turndeviceoffandwait5secondsbeforeturningitonagain

Abnormalitiesonelectricalnetworkorexcessiveelectrostaticdischargesorinternalabnormalities

Turndeviceoffandwait5secondsbeforeturningitonagainIfthesignalpersists,contactPiezosurgeryInc.’sService

IlPIEZOSURGERY®touchisequippedwithadiagnosticcircuitthatallowstodetectoperatingabnormalitiesandtoviewtheirtypeonthekeyboardviatheirrelativesymbol.Byusingthefollowingchart,theuserisguidedtowardtheidentificationandpossiblesolutionofthemalfunctiondetected.

Turn-onprocedureincorrect:thedevicehasbeenturnedonwiththefootpedalpressed

Checkthatthefootpedalisnotpressed.Iftheproblempersists,disconnectthepedaland,ifneedbe,contactPiezosurgeryInc.’sService

28

09.2 Û QUICK SOLUTION TO PROBLEMS

Problem Possible cause SolutionPowercordunpluggedornotcorrectlypluggedintothesocketontherearoftheconsole

Thefootpedalplugisnotcorrectlyinsertedintothesocketontherearoftheconsole

Checkthatthepowersupplycableisfirmlyconnected

Correctlyinsertthepedalpluginthesocketonthebackofthedevice

Theelectricalpowercableisdefective

Thefootpedaldoesnotwork

Thefusesareoutoforder

Checkthatthepowersupplysocketworksproperly.Replacetheelectricalpowercable

Replacetheno-workingfootpedalwiththeback-upfootpedalsuppliedwiththedeviceandcontactPiezosurgeryInc’sService

Replacethefuses(seeparagraph09.3)

The device does not power on when when

mains power switch is set to the “I” position

The device is on but not working. The

display does not signal any error

Seeparagraph09.1forthepossiblecause,accordingtothesymbolthathasbeendisplayed

Seeparagraph09.1 fortheactiontoundertake,accordingtothesymbolthathasbeendisplayed

The device is on but not working. One of

the following symbols appears on the screen:

Theinsertisnotcorrectlytightenedonthehandpiece

Theirrigationcircuithasnotbeencompletelyfilled

UnscrewandcorrectlyscrewtheinsertagainwiththeMectrontorquewrench(seeparagraph05.4)

FilltheirrigationcircuitviathePUMPfunction(seeparagraph05.4)

A slight whistling sound coming from the PIEZOSURGERY® touch

handpiece is heard during operation.

29


Problem Possible cause SolutionTheinserttypedoesnotforeseeliquidpassage

Useaninserttypewithliquidpassage

Theinsertisobstructed

Thehandpieceisobstructed

Theirrigationlevelonthescreenisadjustedon“0”

Theairinletoftheflowadjusterhasnotbeenopened

Theperistalticpumptubingisincorrectlyinstalled

Excessivepressureoftheimpellerontheperistalticpumptube

Theliquidbagisempty

Unscrewtheinsertfromthehandpieceandfreetheinsertwaterpassagebyblowingcompressedthroughit.Iftheproblempersists,replacetheinsertwithanewone

ContactPiezosurgeryInc.’sServiceAdjusttheirrigationlevel

Opentheairinletoftheflowadjuster

Checktheconnectionsofsilicontubing

Checkthatthetubeinsidetheperistalticpumpisproperlypositioned(Seeparagraph04.3)

Replacethebagwithafullone

No liquid outflows from the insert during

operation

The device works properly but the pump strains/

stresses

Thelidoftheperistalticpumpisnotclosedcorrectly

Theinsertisnotcorrectlytightenedonthehandpiece

Insertbroken,worn-out,ordeformed

Checkthatthelidoftheperistalticpumpisperfectlyclosed(Seeparagraph04.3)

UnscrewandcorrectlyscrewtheinsertagainwiththeMectrontorquewrench

Replacetheinsertwithanewone

The pump turns correctly, but when it stops,

liquid outflows from the handpiece

Insufficient performance

30

09.3 Û REPLACEMENT OF THE FUSES

Applyleveragewithaflatscrewdriver,insertingitstipintheseatofthefuse-holderdrawerlocatedunderthepowersupplysocket

WARNING: Switch the device off.AlwaysswitchconsoleOFFanddisconnectpowercordfromtheelectricalpowersocketbeforeperformingthefollowingintervention

WARNING:ReplaceexclusivelywiththetypeoffuseindicatedontherearoftheconsoleorintheChapter08-TECHNICALDATA

Pulloutthefuse-holderdrawer

Reinsertthedrawerinitshousing

1

2

3

31

ForallPiezosurgeryproductsunlessotherwisespecified.Anynon-approvedusageofthePIEZOSURGERY®touch devicewillvoidthewarranty.Anyusageofnon-Piezosurgeryparts,inserts,componentsorprocedureswillvoidthewarranty.Themanufacturer,MectronS.p.a.,warrantstothefirstoriginalpurchaser(customer)thattheirproductshavebeentested,inspectedandshippedinproperworkingorder.AllPiezosurgeryproducts,withtheexceptionnotedbelow,arecoveredbywarrantyforaperiodofoneyearfromthedateofpurchase.Productsarewarrantedtobefreefromdefectsinmaterialandworkmanship.ThislimitedwarrantyisextendedonlytothefirstcustomerpurchasingthePiezosurgeryproductsdirectlyfromPiezosurgeryInc.Thislimitedwarrantydoesnotapplytoanydevice/accessorywhichhasbeensubjecttoabnormalwearandtear,misuse,abuse,neglect,improperinstallationoroperationorthathasbeenaltered,adjustedortamperedwithbyanypersonotherthatPiezosurgeryInc.authorizedservicepersonnel.ThewarrantyisvalidonlyifPiezosurgeryInc.isnotifiedwithinthirty(30)daysfollowingdiscoveryofadefect.Forreturningproceduremakereferencetotheparagraph:“CUSTOMERSERVICE–RETURNSand/orREPAIRS”ReturnsmustbeauthorizedbyPiezosurgeryInc.PiezosurgeryInc.cannotacceptresponsibilityforreturnswhichhavenotbeenauthorized.ContactPiezosurgeryInc.CustomerServiceat88887PIEZOx8forreturnauthorization.

ThiswarrantyisvalidonlyiftheproductisreturnedtoPiezosurgeryInc.withinthirty(30)daysofPiezosurgeryInc.receivingnoticeofsuchdefect,asdescribedabove.ThecustomerisresponsibleforreturningthedefectiveequipmenttothePiezosurgeryInc.,servicelocationathisorherownexpense.Withinareasonabletimeafterreceiptofproduct/s,PiezosurgeryInc.,servicewillinvestigateandshallcorrectanydefectcoveredbywarrantybyproviding,atitsoption,oneofthefollowing:serviceorrepairoftheproduct,orareplacementoftheproduct.IfuponexaminationbyPiezosurgeryInc.’sservicepersonnelitisdeterminedthatthemalfunctioniscausedbyabnormalwearandtearorbydamagecausedbymisuse,abuse,tamperwith,orbyfailuretoperformnormalandroutinemaintenanceassetoutintheinstructionsforuseandmaintenancebookletoriginallyprovidedwiththedevice,warrantyprovisionswillnotapply.Inthiscaseanestimateforthecostofrepairwillbegiventothecustomerpriorservicingandrepairingtheproduct.Therepairwillbebilledtothecustomerinthesamemannerasoutofwarrantyrepair.Forselectedproducts:• Diamond coated inserts are not warranted.

Û 10 LIMITED WARRANTY

10 Û LIMITED WARRANTY

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Ifyouneedtechnicalassistanceregardingtheuse,oryouencounteraproblemthatrequiresservicingorrepair,contactPIEZOSURGERYInc.CustomerServiceat(1 888 87PIEZO).Returningproductsforanyreason,requiresareturnauthorizationnumberthatcanbeobtainedbycontactingPiezosurgeryInc.CustomerService.Pleaseprovidethefollowinginformation:•Productname•Serialnumber/lotnumber(ifapplicable)•Reasonofreturn•OriginalInvoiceNumber•Dateofpurchase

REPAIRSProductsreturnedforrepairmusthaveareturnauthorizationnumberthatmustbeincludedonallpaperworkandclearlyvisibleonthepackagesenttoPiezosurgeryInc.ContactPiezosurgeryInc.CustomerServiceandprovidethefollowinginformationtoobtainareturnauthorizationnumberpriortoreturninganyproductforrepairing.Makereferencetothisnumberforinquiriesregardingtherepairstatus.•Productname•Serialnumber/lotnumber(ifapplicable)•Detaileddescriptionoftheproblem•OriginalInvoiceNumber•DateofpurchaseIfyourequireaquote–NotifyCustomerService,whenrequestingthereturnauthorizationnumberthataquoteisrequired.Ifaquoteisnotrequestedtherepairwillbeprocessedandyouraccountbilledaccordingly–providedtherepairisnotcoveredunderwarranty.

RETURNED GOODSAllreturnsmusthaveareturnauthorizationnumberthatmustbeincludedinalltheshippingdocumentsandclearlyvisibleonthepackagesenttoPiezosurgeryInc.Allreturnsmustbeshippedprepaidfreight,otherwisetheywillnotbeaccepted.

CAUTION: Packaging.Packtheequipmentinitsoriginalpackagingtoensureitisnotdamagedduringshipment.

WARNING:lltheproductsmustbecleanedandsterilizedbeforereturning.PiezosurgeryInc.willnotacceptandprocesspotentiallybio-contaminatedproductswhichdonotmeetthisrequirement.Contaminatedproductswillbeimmediatelyreturnedtoyou,atyourexpense,fordecontaminationandsterilization.

Thiswarrantygivesyouspecificlegalrightsandyoumayhaveotherrightswhichvarybystateandmunicipality.Theforegoinglimitedwarrantyisinlieuofallotherwarranties,expressedorimplied,including,butnotlimitedto,theimpliedwarrantiesofmerchantabilityandfitnessforaparticularpurpose.Exceptclaimsforpersonalinjury,innocaseshallthecompanybeliableforanyspecial,incidentalorconsequentialdamagesbaseduponbreachofwarrantyoranyotherlegaltheory.Somejurisdictionsdonotallowlimitsonwarranties,oronremedies,and,insuchjurisdictions,thelimitinthisandtheprecedingparagraphsmaynotapply.

Theindicationsthatappearinthispublicationarenotbindingandcanbemodifiedwithoutfore-notice.TheItalianversionofthismanualistheoriginaldocumentfromwhichitstranslationshavebeenobtained.Incaseofanydiscrepancy,theItalianversionwillhavepertinence.

Texts,images,andgraphicsofthismanualarepropertyofMectronS.p.A.,Carasco,Italy.Allrightsreserved.Thecontentscannotbecopied,distributed,changed,ormadeavailabletothirdpartieswithoutthewrittenapprovalofMectronS.p.A.

10.1 Û CUSTOMER SERVICE - RETURNS AND/OR REPAIRS

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