ATS Dental B-ONE Manual

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USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
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Mechanicaldriveunitwithcoolantsupplyfordrivinginstrumentswithcompatible
connectionaccordingtoISO3964(DIN13940),suitableforuseindentalsurgery,
implantologyandstomatologicalsurgery.
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REFModel
BNE300
B‐ONE
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Refertothe“REF”onthebottomtoidentifythemodel.
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USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
1.SYMBOLS
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0425 
2017/745UE
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Riskofelectricshock
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FollowInstructionsforuse
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DisposalInformation
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TypeBappliance
V
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SupplyVoltage
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Manufacturer
REF
Reference
#
ModelName
SN 
SerialNumber
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Webusermanual
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ClassIEquipment
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Mode:continuousoperation
withintermittentload
Productionyear
MEDICAL DEVICE
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Readthisinstructionbookletcarefullybeforeinstallingandusingthemachine.Inthisway,youwillobtainthebestpossibleresults
andmaximumoperatingsafety.Thisbookletmustbekeptwiththeapparatusincaseofsaleortransfertoanotheruser.
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2.NOTICE/WARNING
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DMClassificationReg2017/745UEC(AnnexVIII)CLASSIIarule9.
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ClassificationCEIEN60601
ClassIEquipment
TypeBFAppliedPart
OrdinaryEquipment‐degreeofprotectionagainstingressofwater
Notsuitableforuseinthepresenceofaflammableanestheticmixturewithairorwithoxygenornitrousoxide.
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2.1Purpose–Properuse:
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B‐ONEisintendedonlyforuseinthefieldofdentistry,forsurgerytoexposeanddissectoraltissuestructures(suchastheperiodontal
gap,gingival,bone,thejaw,extractions,andimplantations).Theproductmaynotbeusedforapurposeforwhichitwasnotintended.
"Properuse"includesfollowingalltheinstructionsforuseandensuringthatallinspectionsandservicetasksareperformed.
Theoverarchingguidelinesand/ornationallaws,nationalregulations,andtherulesoftechnologyapplicabletomedicaldevicesforstart‐
upanduseoftheATSDENTALproductfortheintendedpurposearetobeappliedandcompliedwith.
Theusermustensurethatthattheunitworksproperlyandisinasatisfactoryconditionbeforeeachuse.
Duringuse,nationallegalregulationsmustbeobserved,inparticular:
theapplicablehealthandsafetyregulations
theapplicableaccidentpreventionregulations
Usershaveadutyto:
Onlyuseequipmentthatisoperatingcorrectly.
Toprotecthimself,thepatientandthirdpartiesfromdanger
Toavoidcontaminationfromtheproduct
Deviceusers:
UseoftheB‐ONEisrestrictedsolelytoqualified,trainedandcompetentdentalhealthpractitionersinthenormalcontextof
theirwork.
Ifyouhavereceivedthisdevicebyerror,pleasecontactthesuppliersothatitcanberemoved.
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MD

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USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
Userpopulation:
Thismedicaldevicecanonlybeusedbyskilledandcapablequalifieddentalhealthprofessionals,asapartoftheirnormalactivities.The
usermusthaveaperfectpracticalknowledgeoftheaccepteddentalrulesandpracticesincompliancewithestablisheddataofthe
science,andoftheprinciplesofmedicalhygienesuchasthecleaning,disinfection,andsterilisationofmedicaldevices,andmustobserve
thoserules,practicesandprinciples.
Thismedicaldevicecanbeusedirrespectivelyofspecific(adult)userdetails,suchasweight,age,height,gender,andnationality.The
usermustweargloves.Theuserisnotthepatient.
Usersmustnothaveanyofthefollowingailments:
Eyeproblemsunlessthelatterareappropriatelycorrected.
Disabilityoftheupperlimbs(correctholdingofarotaryhandpiece)orofthelowerlimbs(operationofacontrolpedal).
Earproblems(useofaudiblesignals,dependingontheequipment).
Memoryorconcentrationproblems(settings,sequences,ormedicalprocedures,etc.).
Specifictrainingforusers:
Nospecifictrainingotherthantheoriginalprofessionaltrainingisrequiredtousethismedicalequipment.
Patientpopulation:
Thismedicaldeviceisintendedforuseonthefollowingpatientpopulation:children,teenagers,adults,andelderlypeople.
Thismedicaldevicecanbeusedirrespectivelyofspecificpatientdetailssuchasweight(exceptforchildren),age,height,gender,and
nationality.Theuseofthismedicaldeviceisprohibitedonthefollowingpatientpopulation:infants,pregnantorbreastfeedingwomen,
patientswithmedicalcomplications,allergicpatients,patientswithaclinicalzonethatisnotsuitableforthetreatment.Thepatient
mustbecalm,relaxed,still,andideallylyingonadentalchair.
Bodyareasortypesoftissuetreated:
Themedicalcarecanonlybecarriedoutinthepatient'soralenvironment.
Principleofoperationofthemedicaldevice:
Anelectricalsignaloutputbythemedicaldeviceissuppliedtothemicromotor(dentalororalsurgery).Themicromotorisconnectedto
medicaldevicebyalead.
Themicromotorisequippedwitharotaryinstrumentholderontowhichatool(drill,burs,etc.)isattached.Therotationofthe
micromotoractivatesthetool.
Part(s)applied:
Rotaryinstrumentholder.Tool(drill,bur,etc.).
Utilization:
Themedicaldevicemustnotbeusedaboveanaltitudeof2,000metres(6,500feet).
Themedicaldeviceisnotrestrictedbyalimitednumberofutilisations.
Electricalconnection:
Yourdevicemustbeconnectedtotheelectricpowersupplybyacertifieddentalinstallationtechnician.Theelectricsupplyto
whichthedeviceisconnectedmustcomplywiththestandardsinforceinyourcountry.
Usingthedevice:
Donotusethedeviceifitappearstobedamagedorfaulty.
Turnthedeviceoffbeforeunpluggingthepowercord.
Tounplugthepowercord,griptheexternaltransformerandholdthewallsocket.
Neveruseanyotherirrigationsolutioncontainersthanthoseintendedforsuspensionfromthesuppliedbrackets.
Thedevicemustonlybeusedwithbottlesorbagsofphysiologicalsaline.
Thecapacityoftheirrigationsolutioncontainersusedmustnotexceedoneliter.
Whenthedeviceisnottobeusedforalongperiodoftime,unplugthedevicefromtheelectricsupply.
Donotmovethedeviceduringuse.
Donotinsertanythinginsidethemotor.
The“micromotor”issuppliednon‐Sterile!
Useonlypowercordprovided.
Useforintendedpurposesonly.Failuretoobservetheoperatinginstructionsmayresultinthepatientorusersufferingserious
injury.Beforeusingthisproduct,makesurethatyouhavestudiedandunderstoodtheoperatinginstructions.
Donotinstallwherethereisariskofanexplosion.TheSystemsarenotintendedforoperationinthepresenceofflammable
anestheticsorgases.
DonotdisassembleoraltertheSystemmotor,console,orfootswitch.
Connectmainspowercabletoaproperlyoutletonly.
Nevertouchdrills,burs,orotherhandpiecetipswhentheyarestillrotating.
Handpieceshouldonlybeattachedwhenthemotorhasstoppedrunning.
Environment:
Donotcoverthedeviceorobstructtheventilationvents.
Donotimmersethedeviceinliquid,anddonotuseitoutdoors.
Donottiltthedeviceatananglegreaterthan5°.
Donotplacethedevicenearaheatsource.
Makesurethatthecordsarenotinatrafficpath.
Thedeviceshouldbestoredinitsoriginalpackaginginasafeplace.
Donotexposethedevicetowatervapor,orsplashes.

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
USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
Thedeviceisnotdesignedtoworknearionizingradiation.
Donotinsertmetalobjectsintothedevice(riskofelectricshock,short‐circuitoremissionofhazardoussubstances).
Maintenance:
Beforeandaftereachuse,yourdevicemustbedisinfectedwithproductsrecommendedbythemanufacturer.
Beforeeachprocedure,itisessentialtomakesurethattheaccessoriestobeusedhavebeencleaned,disinfected.Donotuse
agentscontainingphenol,peraceticacid,peroxideandotheragentsthatbreakuptheoxygen.
DONOT(foranyreason),lubricatethemicromotor.Afterlubricatingthehandpiece,ensurethatthelubricantdoesnot
penetrateintothemicromotor.
Accessories:
ThedevicecanonlyacceptaccessoriesdistributedbyATSDENTALfortheparticularuseforwhichtheyareintended.
Useofaccessoriesfromothermanufacturersisapotentialhazardforyouoryourpatients.
Repair:
Donotrepairormodifythedevicewithoutpriorauthorizationfromthemanufacturer.
Inthecaseofafault,contactthesupplierofyourdevice.Donotuseunauthorizedrepairers,whomightmakeyourdevice
dangerousforyouandyourpatients.
Ifyouhaveanydoubt,contactanapproveddealerorourcustomersupportdepartment:
Informationconcerningtheaccuracyandprecisionofthisproductmaybeobtaineduponrequestbycontacting:
ATSDentalsrlViaVecchiaProvincialeLucchese,49/FSerravallePistoiese–Italy
Tel:+390573518137[email protected]
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2.2ElectromagneticInterferences
Toavoidpossiblerisksofelectromagneticinterferencesdonotuseotherelectro‐medicalinstrumentsofsimilarnaturenearB‐
ONE.Theunitcomplieswiththecurrentnormativeelectromagneticradiationlaw.
ThisdevicehasbeentestedandfoundtocomplywiththeemissionsrequirementsofIEC60601‐1‐2.Theserequirements
providereasonableprotectionagainstharmfulelectromagneticinterferenceinatypicalmedicalinstallation.However,high
levelsofradiofrequency(RF)emissionsfromelectricaldevices,suchascellularphones,maydisrupttheperformanceofthis
device.Tomitigatedisruptiveelectromagneticinterference,positionthisdeviceawayfromRFtransmittersandothersources
ofelectromagneticenergy.
Thedevicecomplieswithapplicableelectromagneticcompatibilitystandards.Theusershouldneverthelessensurethatany
potentialelectromagneticinterferencedoesnotcauseanadditionalrisk(presenceofradiofrequencyemitters,electronic
devices,etc.).Interferencemayoccurwhenusedonpatientswithcardiacpacemakers.Thissystememitselectromagnetic
fields,whichmeanstherearesomepotentialrisks.Themalfunctioningofimplantabledevicessuchascardiacpacemakersand
ICDs(implantablecardioverterdefibrillator)ispossible.Askpatientsandusersiftheyhaveanimplanteddevicebeforeusing
thisproduct.Explainthecircumstancestothem.Weighttherisksandbenefitsandcontactyourpatient'scardiologistor
appropriatequalifiedhealthcareprofessionalpriortoperformingthetreatmentKeepthisproductawayfromimplanted
devicesMakeappropriateemergencyprovisionsandtakeimmediateactionifpatientsbecomeill.Symptomincludingaraised
heartbeat,irregularpulse,anddizzinessmaysignalproblemswithacardiacpacemakerorICD.
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2.3Responsibilityofthemanufacturer
TheATSDentalcanonlyacceptresponsibilityforthesafety,reliability,andperformanceoftheB‐ONEwhenthereiscompliancewith
thefollowingdirections:

•TheB‐ONEmustbeusedinaccordancewiththeseInstructionsforUse.
•TheB‐ONEhasnocomponentswhichcanberepairedbytheuser.
Assembly,modifications,orrepairsmustonlybeundertakenbyanauthorizedserviceorganization.
•Unauthorizedopeningoftheequipmentinvalidatesallclaimsunderwarrantyandanyotherclaims.
•UseonelectricalcircuitcomplyingwiththetermsofregulationCEI64‐8section710.
•UseofcomponentswhicharenotoriginalordifferentfromthosespecifiedintheparagraphPACKAGECONTENTS.
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2.4Disposaloftheequipment
Pleaseobservetheregulationsapplicableinyourcountry.
WithintheEuropeanEconomicCommunity,CouncilDirective2002/96/EU(WEEE)requiresenvironmentallysoundrecycling/disposalof
electricalandelectronicdevices.Yourproductismarkedwiththeadjacentsymbol.Disposalofyourproductwithdomesticrefuseisnot
compatiblewiththeobjectivesofenvironmentallysoundrecycling/disposal.Theblackbarunderneaththe"garbagecan"symbolmeans
thatitwasputintocirculationafterAug.13,2005.(SeeEN50419:2005)PleasenotethatthisproductissubjecttoCouncilDirective
2002/96/EU(WEEE)andtheapplicablenationallawofyourcountryandmustberecycledordisposedofinanenvironmentallysound
manner.Pleasecontactyourdealeriffinaldisposalofyourproductisrequired.
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NOTICE:
Itisnecessaryfortheusertoreporttothemanufacturerandthecompetentauthorityofhisstateanyseriousaccidentthatoccursin
relationtothedevice.
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
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3.PACKAGECONTENTS
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REFModel
BNE300 
“B‐ONEAutoclavableMotor+DeLuxePedal+L.E.D.Light”
ElectronicControlConsole
MicromotorAssemblyAutoclavable
Pedal“DeLuxe”
IrrigationBagHangerRod
PeristalticPumpIrrigationLine(seepage15)
C‐PowerSupply
L.E.D.Light
1ContrangleLED–20:1(seepage15)
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Refertothe“REF”onthebottomtoidentifythemodel.
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
4.SETUP
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4.1Environmentalandtransportconditions:

Internaluse.Altitudelowerthan3000m(10,000ft).
Temperature:18°C/40°C(64°F/104°F).
RelativeHumidity:<80%(non‐condensing).
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4.2Safetyprecautions:

a) Donotinsertanythinginsidethemotor.
b) The“Motor”issuppliednon‐Sterile.
c) UseonlypowercordasdescribedinthesectionPackageContents
d) Useforintendedpurposesonly.Failuretoobservetheoperatinginstructionsmayresultinthepatientorusersuffering
seriousinjury.Beforeusingthisproduct,makesurethatyouhavestudiedandunderstoodtheoperatinginstructions.
e) Donotinstallwherethereisariskofanexplosion.TheSystemsarenotintendedforoperationinthepresenceof
flammableanestheticsorgases.
f) DonotdisassembleoraltertheSystemmotor,console,orfootswitch.
g) Connectmainspowercabletoaproperlygroundedoutletonly.
h) Nevertouchdrills,burs,orotherhandpiecetipswhentheyarestillrotating.
i) Handpieceshouldonlybeattachedwhenthemotorhasstoppedrunning.
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4.3Settinguptheunit:

1. Cuttheadhesivetapeandopenthesuitcase.Removetheunitanditsaccessoriesfromtheiroriginalpackagingandplace
onaflatsurface.Notinstallnearheatsources,directorindirect.
2. Verifythecontentsoftheboxaccordingtothesection“PACKAGECONTENTS”
3. Donotkinkthemotorhosesinceitmaydamageit.
4. Allaccessoriesaresuppliednon‐sterileexceptfortubing.
5. TheserialnumberontheUnit’srearpanelmustbethesameastheoneontransportdocuments.
6. Allowatleast150mmfreespacearoundtheunitforcoolingventilation.
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DamageinTransit
Ifthepackagingisvisiblydamagedondelivery,pleaseproceedasfollows:
a. Therecipientofthepackagemustrecordthelossordamageonthedeliveryreceipt.Therecipientandtherepresentativeof
theshippingcompanymustsignthisdeliveryreceipt.Withoutthisevidence,therecipientwillnotbeabletoassertaclaimfor
damagesagainsttheshippingcompany.
b. Leavetheproductandpackagingintheconditioninwhichyoureceiveditanddonotusetheproduct.
Iftheproductisdamagedbuttherewasnodiscernabledamagetothepackagingupondelivery,proceedasfollows:
a. Reportthedamageimmediatelyoratleast7daysafterthedeliverytothedeliverycompany.
b. Leavetheproductandpackagingintheconditioninwhichyoureceiveditanddonotuseadamagedproduct.
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4.4Assemblingtheunit

MicroMotorconnection
Connectthemicromotorintothereceptacleonthefrontofthecentralunit.
ConnecttheContrangletotheMicroMotor.
Onlyfor“REF”ABNE300pressthebuttonontherearsidetoswitchonLEDLight
PlacetheMicroMotoronthemotorholder.
FootPedalconnection
Connectthefootpedalintothereceptacleonthefrontofthecentralunit.
Placethefootpedalontheground.
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Whileinsertingtheplug,aligntheguideontheconnectorinanuprightpositiontofitintothecorrespondingfemaleguideontheB‐ONE.
Connectorshaveaspringretentionsystemtohelpavoidaccidentallydisconnectingtheunit'scordsandcables.
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
5.CONTROLPANELFUNCTIONS
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1.MotorPumpON/OFF
2.PompON/OFF
3.Pumpflow
4.Set5Programs
5.SetTorque+/‐
6.SetSpeed+/‐
7.Ratioofthecontrangleinuse
8.FWD/REV
9.Calibration
10.LEDON/OFF
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6.CONSOLEBACK
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3
2
REF: BNE300
1. PUMP
2. I POWER On/OffMAIN
3.. Power Cord In
1
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
7.PEDAL(FOOTCONTROLOPERATION)
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“REF”:BNE300
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“DELUXE”
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Theleft‐handbuttonallowsusertochangethevalueofthe
coolantpumpaswellasthekey“flow”onthekeyboard.
Thecentralupbuttonallowsusertochangetheprogramsas
wellasthekey“P‐programs”onthekeyboard.
Theright‐handbuttonallowsusertoswitchbetweenforward
andreversemotorrotation(wheninreverse,consolewillemit
abeepingtone),aswellasthekey“Fwd/Rev”onthekeyboard.
Thecentraldownbuttonallowsusertocontroluptothepre‐
selectedmaximumspeedandswitchonthepumpifenabled.
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8.IRRIGATIONLINESETUP
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1. OpenthepumpInserttherotorofthepumpinsidethepump.Closethepump.
2. Hangthebottleorbagofphysiologicalsalinefromthebracket.
3. Inserttheirrigationlineperforatingintothebottleorbagofphysiologicalsaline.
4. Connecttheendofirrigationlinetothecontrangle.
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NB:UseonlyATSDENTALTube.Donotrunthepumpwithouttube.
Donotusecoolantreservoirsthatcanholdmorethan1liter.Ensurethatthedeviceisstandingsecurely.Usetransparentcoolant
reservoirs.
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NB:Onlyincaseofusinganewinjector,
andonlyifareducedflowofthecoolant
isfelt,insert2dropsofSILICONEOIL
(easilyavailableonthemarket)inthe
centeroftherotortolimitfriction.
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
9.Use
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AftertheunithasbeensetupandtheuserhasbecomefamiliarwiththeSystem’scontrolpanelfunctions:
1. Attachtheappropriate"E‐Type"handpiecetothemotor.Itcanbeusedwithmostsurgicalcontra‐angleswithoutinternal
lightorsprayonthemarket.UseonlyhandpiecethatconformtoISO3964.Changethehandpieceandanglepieceonlywhen
themotornotrunning.
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1. Insertbaghangerrodintosocketonthetopoftheconsole.
2. Attachthemotortotheconnectorontherightside(facingtheunit)onthefrontpanel.
3. Attachthefootcontroltotheconnector(graycolor)onthefrontpanel.
4. Installirrigationtubingintopumpontherearpanel.Useonlytubingasdescribedin“IrrigationTubeSetUp”.
5. Switchon(ontherearpanel.
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IneveryprogramPrograms[1to5]aresetthesameparametersbythemanufacturer.
Performtorquecalibration,press“Calibr”keyonfrontpanelwhileholdingthemotor.Thisfunctionchecksthehandpiecemechanical
inertia,tooff‐setthisvalue.
Thisoperationwilltakeafewseconds,thedrillwillrunatdifferentspeed.
Thedrillmustnotbeengagedinanyoperationwhenthisfunctionisperformed.
Calibrationshouldbedonebeforeeachsurgicalsessionoranytimethehandpieceischangedorlubricated. 
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B‐ONEwillstoretheoperativeparametersforeach“program”assoonastheusersetsthem.Theywillbemaintainedinthememory
evenifthecentralunitisswitchedoff.Foreach“program”itispossibletosetspeed,torque,ratio,directionofrotationandflow.To
resettheparametersofthemanufacturer(SystemReset),pressthe“PUMPON/OFF”keywhiletheunitisswitchedon.Waituntilthe
endoftheoperation.

9.1Programmingtheunit
GEARRATIO:Setshandpiecereductionratio.Seetheavailablereductionratiointhefollowingtable:

1:116:120:124:132:164:180:1
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SPEED+/‐ : Setsmotorrotationspeed(valueinrpm).Speedvaluesdependoncontra‐anglereductionrate.
Maxspeedis2000rpmwith20:1contrangle.Minspeedis20rpmwith20:1contrangle.
TORQUE+/‐:increasesordecreasesthetorquevalues.TorquevaluesareinNcmanddependoncontra‐anglereductionrate.
Maxtorqueis80Ncmwith20:1contrangle.
Payspecialattentiontousethesameratioofthehandpiece.Torqueaccuracyisguaranteeonlywith20:1Contranglecorrectly
maintained.Thetorquevaluesareonlyforhandpiecesthatoperateproperly.Micromotorstopswhensettorqueisreached.Thetorque
valueincounterclockwiserotationisalways=MaxNcm
L.E.D.=LEDON/OFF
FLOW : Selectsvariableirrigationpumpflowrate.Seethefollowingtable:

0=noirrigationMINMEDMAX
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F/R:Switchbetweenforwardandreversemotorrotation(wheninreverse,consolewillemitabeepingtone).
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MOTORON/OFF:SwitchesmotorONandOFF(ifenabled).PUMPON/OFF:SwitchespumpONandOFF(ifenabled).
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USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
10.CleaningandSterilization

Unplugthemainunitfrompowersourcebeforecleaningordisinfecting.Donotusedirectlyonliquidsandsprays.Neverimmersethe
unitoritspartsinliquid.
Externalsurfaceoftheconsolemaybecleanedwithadampclothordisinfectantwipe.Thehousingisnotwaterproof.Donotuse
ultrasonicorsteamsterilizers.Externalsurfaceofthemicromotormaybecleanedwithadampclothordisinfectantwipe.Donotplace
micromotorinultrasonicsterilizers.MotorHolderandIrrigationBagHangerRodmaybecleanedwithadampclothordisinfectantwipe.
Theexteriorofthefootcontrolsmaybecleanedbywipingwithasoftclothmoistenedwithmilddetergentordisinfectingsolution.

WHATCANBESTERILIZED:STERILIZATIONMETHOD:
Sterilizationwithsteamorchemicalvapor
Sterilizationtime:18minutesat134°C/2bar.
Donotexceed138°Cor275°F
Coolingdowntime:2hours
Workingtemperature:40°C
Maxsterilizationcycles:500.
Donotsubmergeinanysolutions.
Donotuseultrasoniccleaners.
DonotsterilizewithEthyleneOxide
“REF”BNE300
MicromotorAssembly(Motor‐Cable‐Connector)
MotorHolder
IrrigationBagHangerRod
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Whentreatingpatientswhomayhaveanacute,criticalinfectiousdisease,besuretoobservethehygienicmeasurescitedinapplicable
publicationsandreports.Ifpossible,usesuitabledisposableproductstoavoidthetransmissionofcriticalpathogens.Theseprotectthe
user,thepatient,andallparticipantsinthesurgery.Amicrobiologicallyappropriatecoolantliquidmustbeused.Onlyuseprescribed
isotonicsalinesolutionNaCl0.9(identifiedasaninfusionsolution;followtheinstructionsonthepackageinsert)forcoolingand
sprayingwounds.Notallautoclavescanreach134°C.Notallautoclavesdrawapre‐vacuum.Pleaserefertoyourautoclave
manufacturerforspecificsterilizationinstructions.
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USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
11.Maintenance
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Themicromotorcablehaslimiteddurabilityandisconsideredaconsumableproduct.Thedurabilityofthecableislargelydependent
uponuseandtreatment,i.e.,handling,reprocessingandfrequencyofuse.
Cautionmustbeexercisedwhenconnectingordisconnectingthemicromotorandfootcontrolcablefromthedevicetoavoiddamage
tothecable.
Periodicallyinspectthemicromotorcordfordamagepriortouse.Ifthereisdamagenoted,contacttheManufacturer.
LUBRICATING:
‐Donotoilorlubricatethemicromotor.
RUBBERO‐RING:
‐Ifnecessary,substitute.ContacttheManufacturer
1.Donotattempttodisassemblethemotorormotorconnector.
2.Donotoilorlubricatethemotor.
3.Donotattachahandpiecetothemotorwhilethemotorisrunning.
4.Donotbendmotorcordsharply.
‐TheMicromotorissensitivetoshock.Donotdroporimpactmicromotoragainsthardsurface.
Failuretocomplywithanyoftheaboveinstructionsmayvoidyourwarranty.

12.TECHNICALDATA

ManufacturerATSDental–Pistoia–Italy NominalPower100VA
ModelB‐ONEFrequency50/60Hz
Dimensions185x160x100ProtectionClass1
MaterialsABSTypeBF
MicromotorBrushless40000/30000ClassMDIIarule9inAnnexIX93/42/EEC
Noise<65dBAConsoleIP21
SupplyVoltage24‐30VDCMicromotor
andPedals
IP21
Notsuitableforuseinpresenceofflammableanestheticsoroxygen.
Conditionsofuse:Temp+18°C/+40°C(+64°F/+140°F)RH<80%
ShippingandStorageconditions:Temp+5°C/+65°C(+41°F/+149°F)RH<20‐95%non‐condensing.
Lifeofthedevice:Whenusedasprescribed=5years.Nowarrantyclaimmaybemadeifthefailurehappenssoonerorlaterthan
indicated,becauseofthefrequencyofuse,sterilizationandmaintenance.
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USERMANUALRev25/05/2023
B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
14.”TROUBLESHOOTING”

Problem:Thecentralunitdoesnotswitchon.
PossiblecauseSolution
•PowercordnotconnectedproperlyMakesurethepowercordisproperlypluggedintotheelectricaloutletandthe
connectoronthebackoftheunit.
•Unithasnotbeenswitchedon.Checkthebackoftheunittoseethattheonbuttonhasbeenpressed.

•Brokenconnectionsinside.
•Transformerdamaged.
•PCBfaulty.
•Filtersupplydefective.
•Powerinterrupted.
Immediatelydiscontinueuseofthedeviceandcontactyourdistributor,servicecenter,
orthemanufacturerdirectly.
Problem:Thedisplayisnotworkingproperly
PossiblecauseSolution
•Possibleinterference.Checktoseeifthecentralunithasbeenpositionedtooclosetoanotherelectricaldevice
whichcancauseinterference.Inthiscase,movetheinterferingelectricaldevicefurther
awayfromthecentralunit.
•Brokenconnectionsinside.
•Displaydamaged.
•PCBdamaged.
Ifyoucannotfindthecauseofthemalfunction,immediatelydiscontinueuseofthe
deviceandcontactdealer,theauthorizedservicecenter,orthemanufacturerdirectly.
Problem:Thekeyboardisnotworkingproperly
PossiblecauseSolution
•Keyboarddamaged.
•Brokenconnectionsinside.
Attempttochangeparametersbyusingthefootpedal.
Contactyourdistributor,servicecenter,orthemanufacturerdirectly.
Problem:Themotordoesn’twork
PossiblecauseSolution
•MicromotorcablenotconnectedproperlyChecktoseethatthemicromotorcableispluggedintotheconnectoronthefrontright
ofthecentralunit,disconnectandreconnect
•Contrangledefectiveornotproperly
calibrated.
ChecktheintegrityoftheContrangle.RemovetheContrangleandperformcalibration.
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•Footpedaldamaged.AttempttostarttheMicroMotorbyusingthe[MotorON/OFFbutton]onthecentral
unitkeyboard.Ifunitdoesnotturnon,contactdealer,theauthorizedservicecenter,or
themanufacturerdirectly.
•PCBdamaged.
•Motordamaged.
•Connectorpinsand/orcabledamaged.
Immediatelydiscontinueuseofthedeviceandcontactdealer,theauthorizedservice
center,orthemanufacturerdirectly.
Problem:Themotorstopssuddenly
PossiblecauseSolution
•Keyboardand/orfootpedaldamagedTrytoturnoffthemotorbypressingthe[MotorON/OFF]buttononthekeyboardor
byusingthefootpedal.
Ifthemotorwillnotturnoff,immediatelydiscontinueuseofthedeviceandcontact
dealer,theauthorizedservicecenter,orthemanufacturerdirectly.
•Brokenconnectionsinside.
•PCBdamaged
Immediatelydiscontinueuseofthedeviceandcontactdealer,theauthorizedservice
center,orthemanufacturerdirectly.
Problem:Thepumpisnotworkingproperty
PossiblecauseSolution
•Tubenotcorrectlyinserted
•Tubedamaged.
Toverifythepropertubeconnection,followtheinstructionsonthisDFU.
Checkfordamagealongthetube,kinks,partialocclusions,etc.Arrangeforimmediate
replacementofthetube.
Problem:Thepumpstopssuddenly
PossiblecauseSolution
•Pumpdamaged/blocked.
•PCBdamaged.
Immediatelydiscontinueuseofthedeviceandcontactdealer,theauthorizedservice
center,orthemanufacturerdirectly.
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B‐ONE
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ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
15.ACCOMPANYINGDOCUMENTS
Electromagneticemissions:
B‐ONEisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheB‐ONEshouldonlybeusedinsuchanenvironment.
RFemissions
CISPR11
Group1B‐ONEusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsare
verylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.
RFemissions
CISPR11
ClassB
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B‐ONEissuitableforuseinallestablishmentincludingdomesticestablishmentsand
thosedirectlyconnectedtothepubliclow‐voltagepowersupply.
Harmonicemissions
IEC61000‐3‐2
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ClassA
Conforms
Voltagefluctuation/flicker
emissions
IEC61000‐3‐3
Conforms
ElectromagneticImmunity:
B‐ONEisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheB‐ONEshouldonlybeusedinsuchan
environment.
ImmunitytestTestlevel
EN60601‐1‐2
CompliancelevelElectromagneticenvironment‐guidance
Electrostaticdischarge
(ESD)EN61000‐4‐2
6kVcontact
8kVair
6kV
8kV
Floorshouldbewood,concrete,orceramictile.If
flooriscoveredwithsyntheticmaterial,therelative
humidityshouldbeatleast30%
Burst/Fasttransient
EN61000‐4‐4
2kVforpowersupply
lines

2kVforpowersupply
lines

QualityoftheMainpowersourceshouldbethatofa
typicalcommercialorhospitalenvironment
Surge
EN61000‐4‐5
1kVdifferentialmode
2kVcommonmode
1kVdifferentialmode
2kVcommonmode
QualityoftheMainpowersourceshouldbethatofa
typicalcommercialorhospitalenvironment
ImmunitytestTestlevel
ICE60601
CompliancelevelElectromagneticenvironment‐guidance
Voltagedips,short
interruptionsand
voltagevariationon
powersupplyinput
lines.







EN61100‐4‐11
5%Ut
(95%dipinU
t
)for0,5
cycle

40%Ut
(60%dipinU
v
)for5cycle

70%U
t

(30%dipinU
t
)per25
cycle

5%U
t
(95%dipinU
t
)for5sec
5%Ut
(95%dipinU
t
)for0,5
cycle

40%Ut
(60%dipinU
v
)for5
cycle

70%U
t

(30%dipinU
t
)per25
cycle

5%U
t
(95%dipinU
t
)for5
sec
QualityoftheMainpowersourceshouldbethatofa
typicalcommercialorhospitalenvironmentIfthe
useroftheB‐ONErequirescontinuedoperation
duringpowermaininterruptions,itisrecommended
thantheB‐ONEbepoweredfromanuninterruptible
powersupplyorbattery.
Powerfrequency
(50/60Hz)
magneticfield

EN61100‐4‐8


3A/m3A/m
Powerfrequencymagneticfieldsshouldbeata
typicalcommercialorhospitalestablishmentlevel.
B‐ONEisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheB‐ONEshouldonlybeusedinsuchan
environment.



USERMANUALRev25/05/2023
B‐ONE
Page14of16



ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
ImmunityTestTestlevel
IEC60601‐1‐2
Compliancelevel ElectromagneticEnvironment‐Guidance
ConductedRF
EN61000‐4‐6


RadiatedRF
IEC61000‐4‐3
3Vefffrom150KHzto
80MHz


3Vefffrom80MHzto
2.5GHz







3Vefffrom150KHz
to80MHz


3Vefffrom80MHz
to2.5GHz

PortableandmobileRFcommunicationequipment
shouldbeusednoclosertoanypartoftheB‐ONE,
includingcables,thantherecommendedseparation
distancecalculatedfromtheequationapplicabletothe
frequencyofthetransmitter.
Recommendedseparationdistance
d=1,2Pfrom150KHzto80MHz
d=1,2Pfrom80MHzto800MHz
d=2,3Pfrom800MHzto2.5GHz
wherePisthemaximumoutputpowerratingofthe
transmitterinwatts(w)accordingtothetransmitter
manufacturerandrecommendedseparationdistancein
metres(m).

FieldstrengthsfromfixedRFtransmitter,asdeterminedbyanelectromagneticsitesurvey
a
shouldbelessthanthecompliance
levelineachfrequencyrange
b
.Interferencemayoccurintheproximityofequipmentmarkedwiththefollowingsymbol:


RecommendedseparationdistancebetweenportableandmobileRFcommunicationsequipmentandtheB‐ONE
TheB‐ONEisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.Thecustomeror
theuseroftheB‐ONEcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableand
mobileRFcommunicationsequipment(transmitters)andtheB‐ONEasrecommendedbelow,accordingtothemaximumoutput
powerofthecommunicationsequipment.
Ratedmaximum
outputpowerof
transmitter(W)
Separationdistanceaccordinginfrequencyoftransmitter(m)

From150kHzto80MHz
d=1,2P
From80MHzto
800MHz
d=1.2P
From800MHzto2,5GHz
d=2,3P
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

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistance(D)inmeters(m)canbe
estimatedusingtheequationapplicabletothefrequencyofthetransmitter,where(P)isthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmittermanufacturer.


























USERMANUALRev25/05/2023
B‐ONE
Page15of16



ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]
IncludedinRef:BNE300–Model:B‐ONE

1XContra‐AngleHandpiece‐Ref:“201‐ATSL”


Implantology
Contra-angle handpiece
«201-ATSL»
0425
MD

TECHNICAL DATA
Gear Ratio 20:1
CA
2.334-2.350 mm
40000 RPM
2000 RPM
>55 Ncm
Torque
Max motor speed
Clamping system
Max operating speed
Shank diameter of the burs
Catalogue number
Serial number
Manufacturer
Date of manufacture
Thermo washer
disinfectable
Sterilizable up to the
stated temperature
Symbols
Medical Device
MD Reg. 2017/745 UE

SEE“DFU”INTHEPACKAGING


2XIRRIGATIONLINE





USERMANUALRev25/05/2023
B‐ONE
Page16of16



ATSDENTALsrl–51034SerravallePistoiese–Italy–www.atsdental.it–[email protected]


Manufacturer






Formoreinformation,contact:
ATSDENTALsrl
ViaVecchiaProv.leLucchese,49
51034SerravallePistoiese
Italy
+390573518137
www.atsdental.it‐[email protected]

Note:theinstructionsabovehavebeenvalidatedbythemanufacturerofthedeviceassuitableforpreparingthe
deviceforreuse.
Theproperimplementationofthepreparationprocess,aswellasachievingthedesiredresult,arefullresponsibility
ofthepersonperformingtheoperation.


ATSDENTALSRLreservestherighttomodifythepresentDFUwithoutpriornotice.


 

ViaVecchiaProvincialeLucchese,49/F‐Loc.Masotti
51034SERRAVALLEPISTOIESE(PT)‐Italy
Tel.:+390573518137–Fax:+3905731711140
[email protected]internet:www.atsdental.it
