small scanner. great comfort. - 3disc · thank you for purchasing the heron™ ios solution from...

User Manual

Small Scanner. Great Comfort.

1. Introducing the Heron™ IOS Solution 1.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.2 Indications supported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.3Certificationandcompliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.4 Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.5 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.6Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2. What’s in the Box

3.SystemRequirementsandSpecifications 3.1SystemSpecifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.1.1 Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.1.2 Scanning Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.1.3Software&LabIntegration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.2ComputerRequirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.2.1RequiredSoftwareandMisc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.2.2RequiredHardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.3EnvironmentConditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.4PowerInput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.5ReusableTips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.6 Scanner – Base and Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

4.HowtoConnect&SetuptheHeron™IOSSolution 4.1 Setting Up and Connecting the Heron™ IOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 4.2Heron™IOSComponentsOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4.3 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4.4 cloud storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

5. Operating the Heron™ IOS Solution 5.1 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 5.1.0CommunicationwiththeLab19 5.1.1CaseManagementSoftwareOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 5.2Indicationworkflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 5.2.1Createneworder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 5.3.Importantthingstoknowbeforescanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.4 Operating the scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.4.1 Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.4.2MandibularandMaxillaryScanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.4.3BiteAlignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 5.4.4Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 5.5ScanningTools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

6. Maintenance 6.1 Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 6.2CleaningandSterilizationofTip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 6.3 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 6.4Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

7.SafetyGuidelinesandWarnings 7.1WarningsandSymbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7.2 General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 7.3 General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 7.3.1SystemModification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 7.3.2ApprovedSoftware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 7.3.3EquipmentFailure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 7.4 Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 7.4.1 Moving Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 7.4.2DroppedEquipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 7.4.3 Base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 7.5ElectricalSafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 7.5.1ElectricalShock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 7.5.2StressonCables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 7.6EyeSafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 7.7 Hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 7.8DuringSystemsOperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 7.9SymbolsontheHeronandTransportCase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

8. Support, Warranty and Repair Service 8.1 Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 8.2 Standard Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 8.3 Repair Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 8.4OutofWarrantyRepairService . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

1. Introducing the Heron™ IOS Solution 1.1. Introduction

ThankyouforpurchasingtheHeron™IOSsolutionfrom3DISC.TheHeron™IOSsolutionisdesignedanddevelopedtoproducehigh-qualitydigitalintraoralscans,ormodels,fordentalrestorationoranalysis.

TheHeron™IOSsolutionisdesignedwithyouasadentistandyourpatientinmind.Thescannerislightweight,smallandeasytouse,enablingafast,accuratescanningandgreatpatientexperience.TheCasemanagementapplicationisordermanage-mentasyouknowitanddesignedforeasyandintuitiveuse.Enjoyyournewintraoralscanner solution!

1.2 Indications supported

Heron™ IOS can be used for the following indications:

∙ Anatomic crowns∙ Copings∙ Provisional crowns∙ Anatomical pontics∙ Reduced pontics∙ Provisional pontics∙ Inlays/Onlays∙ Implant abutments

∙ 3-unit implant bridges ∙ Up to 5-unit bridges ∙ Orthodontic aligners ∙ Nightguards∙ Splints∙ Retainers∙ Bleach trays∙ Sleep appliances

1.3Certificationandcompliance

Thesystemhasbeentestedandconformstothefollowingstandards:

•IEC60601-1,Medicalelectricalequipment-Part1:Generalrequirementsforbasicsafetyandessentialperformance•IEC60601-1-2,Medicalelectricalequipment-Part1-2:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:Electromagneticdisturbances-Requirementsandtests•IEC62471,Photobiologicalsafetyoflampsandlampsystems

1.4 Regulatory

TheHeron™IOSismanufacturedandmarketedinaccordancewithUSFDARegulati-onsandEUMedicalDeviceDirective93-42-EEC.

1.5 Intended Use

TheHeron™IOSisanopticalimpressionsystem.Itisusedtorecordthetopographicalcharacteristicsofteeth,dentalimpressions,orstonemodelsforuseinthecompu-ter-aideddesign(CAD)andcomputer-aidedmanufacturing(CAM)ofdentalrestorativeprosthetic devices.

1.6Classifications

The Heron™ IOS system has the following classifications•Protectionagainstelectricalshock:TypeBAppliedPart•Protectionagainstharmfulingressofwater:Ordinaryequipment(IPX0)•Safetyofapplicationinthepresenceofaflammableanestheticmaterialwithairorwithoxygenornitrousoxide:Equipmentnotsuitableforuseinthepresenceofaflam-mableanestheticmixturewithairorwithoxygenornitrousoxide.

CAUTION:Rxonly-FederallawrestrictsthisdevicetobesoldbyorontheorderofaDentist.

WARNING:Unintendeduseofthesystemcanresultinphysicalinjurytothepatientandoperator,anddamagetothesystem.

2. What’s in the BoxThe Heron™ IOS system includes the following

Name PartNumberHeron™IOSSystem(Includes3Tips) IOS-FP-71-001USB3.0Cable IOS-CP-00-043AC/DCPowerAdapter IOS-CP-00-088

SavetheBox:Itishighlyrecommendedthatyoustoretheboxinasafeplaceanddonotthrowitaway.Theboxisoptimalforanynecessarytransportationorshipmentofthe Heron™ IOS.

3.SystemRequirementsandSpecifications

3.1SystemSpecifications

3.1.1 Scanner

ScannerType Hand-held(chairside)scannerthatcreatesopticalimpressionsfordentalrestorations.

Design Compact,lightweight,ergonomic–designedtobeoperatedwithlittlephysicaleffort.

DimensionsBase Size:L306mm,W98mm,H72mm

DimensionsScanner Weight:150grams

Size:L256mm,W43mm,H43mm

PowerRequirement DC5.0V/4A(Powersupplyincluded)

ScannerTip Reusable,sterilizeusingsteamautoclave

HeatingElement Preventsformationoffogontheoptics

AcquisitionMethod Intraoralcamera–activestereoimaging

Color Scanning 24-bit(8-bitperchannel)

3.1.2 Scanning Process

ToothPreparation Nopowderorsprayrequired

Scanning Principle Continuously scanning and accumulating(stitching)depthand color data

DistanceScanner-Tooth 0–12mm

Possiblecontactdurationbyoperator 10min≤tNote:Mayvarywithhardwareconfiguration

OperatorAccessiblePart Handpiece

Possiblecontactdurationbypatient 10min≤t

Patientaccessiblepart(TypeBAppliedPart) Tip

Computer–ScannerInterface USB 3.0

3.1.3Software&LabIntegration

OutputFileFormat STL,PLY,OBJ

CompatibilitywithCAD/CAMSystems OpenArchitectureOutputformatSTL,PLY,OBJCompatiblewithmostDentalCADsystems

CaseManagementapplicationInterface Touchscreensupport

3.2ComputerRequirements

3.2.1RequiredSoftwareandMisc.

OperatingSystem Windows10(ExcludingWindows10S,nowdefunct)Administrativerightsrequired

DiskSpace 100GBoffreediskspaceorgreater

Ports 1xUSB3.0port(SuperSpeed)2xUSBport

3.2.2RequiredHardware

CPUType Inteli7-4Coresorgreater(e.g.i78700)

CPUClock 2.8GHzclockorgreater

Memory 16GBofRAMorgreater(DDR4orbetter)

GPU NVIDIAGeForceGraphicsProcessor000Series(GTX):1070orGreater1000Series(GTX):1070orgreater-Atleast6GBvideomemory2000Series(RTX):2060orgreater-Atleast6GBvideomemory

NOTE:AMDGPU’sareNOTcompatiblewiththeHeron™IOS.Notmeetingminimumhardwarerequirementswillaffecttheperformanceofthescanner.

3.3EnvironmentConditions

OperatingTemperature 10°C ~ 40°C

OperatingRelativeHumidity 10%~80%(non-condensing)

StorageTemperature - 20°C~60°C

StorageRelativeHumidity 10%~80%(non-condensing)Indooruseonly

Installation Category 1

Pollution Degree 2

IngressofLiquids IPXO

Protective Class ClassIIIb

Overvoltage category I(SuppliedfromoutputDCsource,max.5V.dc,600mA)ofnotebookornon-me-dicalgradePCcertifiedbyIEC60950-1

Max.workingcondition Continuouscycleswithimagecaptureandtransmissionfrom/toNotebookornon-medicalgradePC.

Otherpossibleaccessories(IEC60601-13rd,Cl.16)

NotebookwithAC/DCAdapter.

EquipmentMaintenance Nousermaintenanceisrequired,andnouserserviceisallowed.Pleasecontacttechnicalsupportifthereisaproblem.

Cleaning Donottrytocleantheinsideofthede-vice.RefertoChapter6forcleaningandsterilization.

3.4PowerInputThepoweradapterinputis5VDC,100-240VAC,50-60Hz.

3.5ReusableTipsScannertipisautoclavableupto250timesinasteamautoclave.Seechapter6.

3.6 Scanner – Base and HandpieceThescannerbodyconsistsoftheBaseandHandpiece,whichareconnectedbyaflexible,non-detachablecable.

4.HowtoConnect&Setupthe Heron™ IOS Solution

4.1 Setting Up and Connecting the Heron™ IOS

Install the system according to the following stepsYou can download the software from https://www.3disc.com/support/

Step 1:Placethebaseonaflat,stablesurfaceandplacetheHeron™IOShandpiecesecurelyinitsbase.

Step 2:ConnecttheAC/DCpoweradaptercabletotheBase;theconnectorsocketislocated underneath the Base.

Step 3:ConnecttheprovidedUSB3.0cabletotheBase; theconnectorsocketislocatedunderneaththeBase.

Step 4:ConnecttheotherendoftheUSBcabletothecomputer.

NOTE:UsingaUSBcableotherthantheoneprovidedmayresultinsystemmalfunctionorreducedperformance.

NOTE:ItisstronglyrecommendedtoplugtheUSBcabletoaUSBportlocatedatthebackofthecomputer;notdoingsomayresultinsystemmalfunctionorreducedperformance. MakesuretouseaUSBportthatiscompatiblewithUSB3.0(SuperSpeed),usuallyindicatedbythefollowingsymbol:notdoingsomayresultsystemmalfunctionorreducedperformance.

Ifusingalaptopcomputer,makesurethepowersupplyisconnectedtoanoutletandnotrunningonbatterypower.

Step 5: Connect the AC/DC power adapter to a power outlet.

WARNING: UnsuitableInstallationsites•Locationswithexcessivehumidityordust•Locationssubjecttohightemperature•Locationssubjecttoshakingorvibration•Locationsexposedtoconsiderableelectricalormagneticnoise,orotherformsofelectromagneticenergy

4.2Heron™IOSComponentsOverview

PleasereviewtheHeron™IOSfeaturesshowninthissection.Thiswillhelpyoulocatethefeatureswhentheyaredescribedinsections5-7.

1.Thebaseandscanner

2.Tip

3. Scan Button

4. Handpiece

5.USB3.0Cable

6.AC/DCPowerAdapter

4.3 Settings

General•Language,CurrentlyonlyEnglish.•3DOutputformatcanbeSTL,PLY,OBJ.•PictureformatscanbePNG,JPG.•PreferredstartpagecanbechosentobeRecentPatientsorRecentCases.•TheworkflowFastScancanbeenabledifPatientorCaseisnotneeded.•ViewSoftwareversion(Copyfunctiontotheright)•ViewScanningmoduleversion(Copyfunctiontotheright)•ManualsoftwareUpdatecheck.Automaticcheckisdoneateverylaunch.•LinktoUsermanualandto3DISCsupporthomepage.

�

�

��

�1

SystemUndersystemtheoptiontoexportorimportthepatientdatabase.

SoundsSelect to use the sound during scanning or not.Pre select volume and selectbetween different soundeffects.

UsersAdd, edit and delete users withEmainameandpictureAlsoPasswords canbe ad-ded on the user.

Lab ConnectionsSetup and select connec-tionswith Labs. Also setupthepreferredLabasdefault.

Order FormSelect Tooth numberingsystem. Shade system canbeselected.Patientnamescan be hidden in case ne-eded. New materials canbe importedandexported.Also special materials canbecreatedandedited.

4.4 cloud storage

HeronCloudisthefiletransfercloudsuppliedwithyourHeronsystem.ItcanbefoundonHeronCloud.com

Labsanduserscreateanaccountandsharethefilesfreeviathecloud.Logginginwillgiveanoverviewofthecasescreatedbytheuserorcasessenttotheuserwithcurrentstatus.

The interface supports the following languages: English, Danish, German, Spanish,French,Chinese,Korean

Connections with Labs and dentists is managed by clicking the connections button

Options for the Cloud

1.EditProfileenablestoeditname,mailandsoon.

2.PossibilitytoChangepassword.

3.Groupscanbecreated.

4.SettingscanchangethelookoftheCaseview.

Openingacasefromthelistwillshowalltheinformationneeded.Possibilitiesforchan-gingstatus,lookingatscansin3DViewer,downloadingfilesandaddingfilesarefoundhere.

5. Operating the Heron™ IOS Solution

5.1 Getting Started

Sign in and Creating a new accountAnewaccountneedstobecreatedbeforeitcanbelinkedtoauserinthesoftware.OnHeroncloud.comclick“CreateNewAccount”.Fillintherequiredfields(markedwithared*)andclick“Create”.

Amailwillbesenttoconfirmthemailaddress.Clicktheconfirmationlinkandyouareready to log in to the cloud.

1. Sharefilesdirectlybylocatingthefileinthe“openinExplorer”tabandcopyingthefileintoDropbox,wetransfer.com,emailetc.

2b. Afteryouhavecreatedyouraccountyoucannowconnectwithalabbygoingtoconnectionsmenuandadding connection.

2c. Add your HeronCloud™ connection to settings,yourconnectedlabswillnowappear as options.

2d. Send the cases via HeronCloud™ in the finalizepage.

5.1.0CommunicationwiththeLab

TheCaseManagementapplication,HeronClinic™,containstwobuilt-inmethodsforcommunicatingwiththelab.Youcaneither

1.Accessthescansdirectlybyclickingthe“exportfiles”tab,selectdesiredfilesanddraganddropinyourdesiredplatform.

2. Use HeronCloud™

Login screenUserloginpageisthefirstpagewhenthesoftwareisstarted.Selecttheuserandtypeinpasswordiftheuserissetupwiththat.

5.1.1CaseManagementSoftwareOverview

Start Screen PatientsWhenloggedinyouwillhavePatientsorCasesasdefaultview(selectedinsettings).Selectanalreadycreatedpatient, intheleftsideofthescreen,toviewand/orcreatenewcasesforthepatient.

CreatenewPatientorcasebyusingthebuttonsinthemainpartofthescreen.Settingsarefoundintheupperrightcornerbyclickingthegearwheel.Clickingontheuserintheupperrightcornerwillgivetheoptiontologout.

Start Screen CasesWhenloggedinyouwillhavePatientsorCasesasdefaultview(selectedinsettings).Selectanalreadycreatedcase,intheleftsideofthescreen,toviewthescansandcon-tinuetoallthecasesforthesamepatient.

CreatenewPatientorcasebyusingthebuttonsinthemainpartofthescreen.Settingsarefoundintheupperrightcornerbyclickingthegearwheel.Clickingontheuserintheupperrightcornerwillgivetheoptiontologout.

FiltersPatientsandcasescanbesortedwithfiltersorwithasearchforaspecificword/name.Filtersarechosenviathisbutton:

Creating a new PatientCreatinganewpatientwillopenthescreentotheright.Fill inthedata.Patient ID isautomaticallycreatedbutitispossibletochangetoadifferentIDifneeded.FirstandLastnamearemandatory.When filled in click create and you will be ready to create cases.

Delete a PatientItispossibletodeleteaPatientbyclickingthe3dotstotherightofthenameandselec-tingDelete.Notethatonlypatientswithnocasescanbedeletedsoanycasesunderthepatientmustbedeletedfirst.Itisdonebyclickingthe3dotsnexttothecase.Multiplecasescanbedeletedsimultaneously.

Create a new Case when Patient is selected.Whenapatientisselectedapreviewwillappearwithnameandcasesalreadyonthepatient.Hereyoualsohavetheoptiontocreateanewcaseforthesamepatient,bypressing add case .

5.2Indicationworkflows

HeronClinic™supportsthefollowingrestorationsandappliances:

AnatomiccrownsCopingsProvisionalcrownsAnatomicalponticsReduced ponticsProvisional ponticsInlays/OnlaysImplantabutments

3-unitimplantbridgesUpto5-unitbridgesOrthodontic alignersNightguardsSplintsRetainersBleach traysSleep appliances

5.2.1Createneworder

Tocreateanewpatientorder for theabove-mentioned indications, followthestepsbelow.

Create new CaseWhencreatinganewcasetheOrderFormwillbedisplayed.CheckthecorrectpatientandLabisselectedandthedesireddeliverydatefromtheLab.

Selecting the RestorationSelecttheteethandchoosetherestorationtype.Teethareselectedbyclickingonthemandmultipleteethcanbeselectedsimultaniously.Antagonistareselectedautomaticallybutcanbede-selectedifneeded.Pre-op scan can be selected if desired.

After Restoration is selectedThecolourandmaterialischosen.Noteabridgeisshownbytheouterlinesanddotsnext to the coloured teeth. Push Next when the Order Form is finished.

Scanning PageThe liveViewwindow in the lower left is showingwhat theHeron isactually seeing. It canbe changed In size. Small,Mediumand Large. The 3Dbuilding of the scan isshowninthemiddleofthescreen.Youcancapture2Dimagesbypressing“C”

5.3.Importantthingstoknowbeforescanning

Ifdoingacrown,preparethetoothwithagingivaretractioncord.Thisisoptionalhow-everhighlyrecommended.Priortoscanning,removetheretractioncordanddrythesurfaceofanybloodorsalivausinganair/watersyringeora2x2gauze

5.4 Operating the scanner 5.4.1 Scanning

1. Start ScanTobeginscanning,pressthebuttononthetopof the scanneror youmayclick ‘scan’on therighttoolbarwindow.

Recommended distance from tip to tooth isfrom0-12mm.

2. Green Image Whenthegreenboxispresent,itindicatesthescanissuccessfullystitchingtogether.Tomain-tain the green indicator, remain steady and precisewithyourmovements.

3. Red ImageIn the event of a red box, the scan has lostit’s track and is no longer stitching the scan together. This is caused by unsteady and suddenmovements of the handpiece aswellasalackofcheek/tongueretraction.

4. RestartIfyourscanhaslosttrack,simplyplacethescantipontheocclusalsurfaceofanalreadyscan-ned tooth.Theocclusal surfacehas themostdetailandwillallowthesoftwaretorecognizeitspositionquickly.Facialsurfacesaredifficulttorecognizeastheirsurfacesareflatter.

5.4.2MandibularandMaxillaryScanning

1.Beginyourscanbystartingonthearchofchosenrestoration.Ifscanningbotharches,youmayselecteitherarchtobegin.

2a.Forafullarch,followascanpathofocclusal,lin-gualthenbuccal.Beginningontheposteriortermi-nalmolar,workingacrosstheentireocclusalplaneof the arch, youwill end at the opposing terminalmolar.Whenscanningtheanteriorregion,ensuretoslightlyrollthescantipatleast1mmovertheincisaledgestocapturesomefacialsurface.

2b.Theliveviewwindowtotheleftisthemainpointof reference.While scanning,what is shown in thelivewindowwillappearonthe3Dimage.Ensuretheanatomyofthetoothiscenteredintheviewwindowwithlittletonocheekortissuepresent.

3.Whenfinished scanning theocclusal, startingattheterminalmolar,slightlyrotatethescannerto45degreesscanningtheentirelingualsurfaceoftheen-tirearchendingattheopposingterminalmolar.

4. To scan the buccal surface, again beginning ontheposteriorterminalmolar,youwillrotateat45de-greesscanningthebuccalsegmentstoppingatthemidline.Youwillrepeattheprocessontheopposingterminalmolartoconnectthemidlines.Ensureyoudonotscanallthewayaroundtheentirearchonthebuccal facialsurfaces.Finalize inscanningthebuc-calsideofthemolarswiththescannerina90degreeanglebeingsuretocaptureatleast5mmofgingiva.

5.Whenscaniscomplete,turnthescanneroffbythepowerbuttononthehandleofthescanner.Ifscan-ningbotharches, select theother archnow in thesoftware.

6.Repeatthesamescanpathandstrategyforbotharches.

5.4.3BiteAlignment

Intheeventofaquadrantscan,youwillbeaskedtoscanonlythesideofthequa-drant.Whendoingfullarchscans,youwillbepromptedtoscanbilateral.

Whenselecting‘bite’,allowafewsecondsforthearchscanstoload.

1. Scanning the occlusion1a.Tocapture thebite,youwillbeginscanningonthe centralmolars capturingbothmandibular andmaxillaryteethinthefirstpass.ThenscanonlytheMaxillarymolarsandgingivatillthearch

1b.Oncethearchislocked,thearchwillgettheini-tialscanoverlayedandagreencheckmarkwillap-perlikedescribedbelowindicatingyouarefinishedscanningthatarch.Oncethearchiscomplete,repe-attheprocessfortheopposingarch.

1c.Whenthebitealignmentiscomplete,youmayro-tatethe3Dimagetoconfirmcorrectpatientocclusion.

2.FinalizingWhenscanning isdoneweget theoverviewof thecase incl3Dpreviewof thescans.Additionalnotescan be added and pictures or similar can be atta-chedtothecase.IfconnectedtoaLabviaHeronC-loudthewholecasecannowbesenttothelab.Ad-ditionallythescansandorderformcanbeexportedtoadifferentlocationonthePC.

3DViewerEachofthescanscanbeopenedinthefullscreen3Dviewerforcloserinvestigation.

5.4.4Tip

1. Attach thetipwiththemirrorsidefacingdown-ward.Firmlypressthetipontothescanneruntilyouhearitlockintoplace.

2. Detachthetipbypressingthebuttonlocatedonthebottomofthehandpiece(1)whilepullingawayfromthescanner(2).

3. Rotatethetip180degreesformaxillaryscanningbypressingthebutton(1)locatedonthebottomofthe handpiece.

*It is not required to rotate the tip for maxillary scanning.

1

2

1

2

1

2

3. In the event you may feel that the alignment needs modification, you or your lab can upload the file into a design software for fine tuning. Access the files dire-ctly in Explorer like this.

A ScanEnablesthestartofscanningaswellaspausingthescan.

B ResetResetwilldeletethecurrentscan.

C Adjust Zoom levelYoumaychangethezoomlevel,(helpfulfortouchscreens)

D Center Scan on ScreenMovesthescaninthecenterofthescreen

E Color on/offTogglesbetweencolorandnoncolorscan

F Brush toolUsedtomarkareasonthescanformodification/deletion

G Measurement tool Placespointstomeasuredistance

H Finalize tool Forcesfinalprocessingofthescan

5.5ScanningTools

6. Maintenance

6.1 Cleaning the Handpiece

Theentirebody,cordandbaseof thescannermustbewipeddownusingaFederalEnvironmentalProtectionAgency(EPA)approveddisinfectantthatislabeledandspeci-fiedfortuberculocidal/mycobactericidalactivity.Donotusedisinfectantonthenozzle.

Recommended and approved surface disinfectants:

•BirexWipes:TBClaim=10minutes-‘Phenolic(Dual)Water-Based’•ProsprayWipes:TBClaim=10minutes-‘Phenolic(Dual)Water-Based’•CavicideWipes:TBClaim=3minutes-‘Phenolics(Dual)Alcohol-Based’•DisCideULTRAWipes:TBClaim-1minute-‘Phenolics(Dual)Alcohol-Based’•MaxiwipeGermicidalCloth:TBClaim=5minutes-‘Phenolics(Dual)Alcohol-Based’•Ster1Plus:TBClaim=5minutes-‘QuaternaryammoniumandAlcohol-Based’

6.2CleaningandSterilizationofTip

NOTE:Allcomponentsofthescanner(excludingthetips)mustbewipeddownandnotsprayed.Avoidgettinganymoisture,alcoholordisinfectantinsidetheopenscannerchamber.

NOTE:Theincludedtipsmustbeautoclavedpriortouseastheydonotcomepre-sterilized.

NOTE:Ensurethatthesurfaceofthemirrordoesnotshowresidues,smudges,scratches,oranydamage,asthiswouldaffecttheperfor-manceofthedevice.

Step-by-Step Procedure

Step 1: Cleanthetipwithsoapywater,ensuringthatthemirroriscleanandfreeofsmudges,stains,oranyresidue.Avoidusingabrasiveclothmaterialsasthiswillscratchthemirror.

Step 2:Afterdryingthetipexterior,carefullydrytheinteriorandmirrorwithlintfreewipesensuringyoudonotscratchthesur-face.Themirrorshouldbefreeofanynoticeabledebrisorwaterspots.

Step 3: Insertandsealthetip intoasterilizationpouch.Makesuretheseal isairtight.Eachtipshouldbepackagedindividu-ally.

Step 4:Sterilizethewrappedtipinasteamautoclaveatfollow-ingparameters:

•132°C(270°F)at4minutes,or•134°C(273°F)at4minutes

Step 5:Ensurethedrycycleiscompletepriortoremovingthetipfromtheautoclave.Ifthepouchisdampwithmoisture,pro-persterilizationcannotbeguaranteed.

WARNING:Alwaysautoclavethetipwrappedinasealedsterilizationpouch;failuretodosowillresultinpermanentstainsonthemirror.

NOTE:Tipsshouldnotbeplacedinanultrasoniccleaneroranycoldsterilesolutions.Thesterilantsolutionswillleaveastickyresidueorfilmonthemirrorwhendrying.

WARNING:Donotremovethepouchbeforethesterilizercompletesitsfulldrycycle.Ifthepouchiswetorhasanysignsofmoisture,thiscanpotentiallyleavewaterspotsonthemirrorwhichcanaffectimagequalityduringscanning.

WARNING:Useextremecautionwhencleaningthemirrorasitisverydelicate and is prone to scratching.

WARNING:Donotautoclavethehandpieceofthedevice.

6.3 Disposal

TheHeronisanelectricaldevicewithelectronicalcomponentsinsideandshouldbedisposedofinaccordancewithlocalenvironmentallawsandregulations.

6.4Calibration

TheHeron™IOSiscalibratedinthefactoryandthereforedoesnotrequirecalibrationwheninstalled.

IftheHeron™IOSbeginstohaveproblemsscanningandrecognizingteethmodels,thesystemshouldbeexamined,whichmayresultinthesystembeingreturnedforrepair/calibration.SeeSection8.4forfurtherinfo.

7.SafetyGuidelinesandWarnings

7.1WarningsandSymbols

WARNING: General prohibition indication. The functionality of thesystemcanbedestroyed in thecaseof incorrectuse. Ifunauthorizedchangeshavebeenmadetothedeliveredsystemandaccessories,thewarrantyby3DISCbecomesvoid.3DISCwillnotacceptanyresponsibili-tyorliabilityfortheimproperfunctioningoftheproductinsuchacase.

NOTE:Notesrepresentinformationthatisimportanttoknowbutwhichdonotaffectthefunctionalityofthesystem.

WARNING:Thefunctionalityofthesystemwillbelimitedinthecaseofincorrect use.

7.2 General Guidelines

•Donotspillliquidsonthebodyofthedevice •Neveroperatethedeviceinawetenvironment.•Keepthedeviceawayfromradiatorsandheatsources.•Usethedeviceonlywiththeaccessoriessupplied.• Do not alter the device or open enclosures.

Ifanyofthefollowingconditionsoccur,unplugthedevicefromtheelectricaloutletandcontactauthorizedservicepersonnel:

•Thepowercordorpoweradapterisdamaged.•Thedevicehasbeenexposedtowater.•Thedevicehasbeendamaged.•Thedevicedoesnotoperatecorrectlywhentheoperatinginstructionsarefollowed.

7.3 General Warnings

7.3.1SystemModification

7.3.2ApprovedSoftware

The Heron™ IOS device is designed to operate with the HeronClinic™ software. Seesection4fordetails.

WARNING: General prohibition indication. The functionality of thesystemcanbedestroyed in thecaseof incorrectuse. Ifunauthorizedchangeshavebeenmadetodeliveredsystemandaccessories,thewar-rantyby3DImagingandSimulationCorp.Americasbecomesvoid.3DImagingandSimulationCorp.Americaswillnotacceptanyresponsibili-tyorliabilityfortheimproperfunctioningoftheproductinsuchacase.

WARNING: Modifying the systemmay result in physical injury to the patientandoperator,anddamagetothesystem.

WARNING:TheHeron™IOSscannershouldonlybeusedwithappro-ved,compatiblesoftware.

7.3.3EquipmentFailure

7.4 Mechanical Hazards

7.4.1 Moving Parts

7.4.2DroppedEquipment

7.4.3 Base

WARNING:Incaseofsystemmalfunctionorfailure,youshould:Preventanycontactbetweenthesystemandthepatient.Unplugthesystemfromthepoweroutletandthecomputer.Storethesystemawaysoitcannotbeusedbysomeoneelse.Contact service personal.

NOTE:Allmovingpartsareinsidehandheldscannersodonotopentheunit.

WARNING: If thescannertip isdropped,ensurethatthemirror isnotdamagedandthatitisnotdetached;ifthetipisdamageditshouldbedisposedofimmediately.Ifthescannerhandpieceisdroppedorbum-ped,ensurethatnopartofthesystemisdamagedasitcouldaffectper-formance.

NOTE:Whennotinuse,alwaysrestthehandpieceontheBaseDonotplacetheBaseonaslantedsurface.Placethecables(powercableandUSBcable)wherepeoplecannotaccidentallygetcaught inthemandpotentiallydamagethesystem.

7.5ElectricalSafety

7.5.1ElectricalShock

7.5.2StressonCables

7.6EyeSafety

7.7 Hygiene

WARNING:Thereisariskofelectricalshockwhenopeningorattemp-ting to open any part of the system; only qualified service personalshouldopenpartsofthesystem.

WARNING:Careshouldbetakennottoapplyunnecessarystressonthecablesofthesystem,whetheritisthepowercable,theUSBcableorthecablebetweenthehandpieceandtheBase.

WARNING:Onlyusethepoweradaptersuppliedasapartofthesystem.

WARNING:Duringoperation, thesystememitsabright,flashing lightfromitstip.AlthoughthesystemcomplieswithstandardIEC62471(Pho-tobiologicalsafetyoflampsandlampsystems),prolongedexposuretoflashinglightmayresultindiscomfort,seizureoreyeirritation.

WARNING:Inordertomaintainsafetyforthepatient,wearsurgicalglo-veswhenhandlinganypartsofthesystem.Alwaysensurethatthetipismountedonthehandpiecebeforeinsertingitintothemouthofthepatient.Beforeusingthesystemwithanewpatient,ensurethatthesy-stemisdisinfected,andthetipissterilized.

7.8DuringSystemsOperation

WARNING:TheHeron™IOSsystemcontainsdelicateopticalandme-chanical elements and therefore shouldbehandled carefully.Donotdrop,bump,orshakethehandpieceorthetip.Alwaysplacethehand-pieceontheBasewhennotinuse.Donotputstressonthecablecon-nectingthehandpiecetotheBase.DonotsubmergethehandpieceortheBaseinanyliquid.DonotplacethehandpieceortheBaseonwetorheatedsurfaces.Holdthehandpiecewithafirmgripwhenhandlingit.

NOTE:Duringoperationofthesystem,thehandpieceandthetipmaygetslightlywarm;thisisnormal.

WARNING:Inordertopreventover-heatingofthesystem,theventilati-onopeningatthebottomofthehandpieceshouldneverbeobstructed.

7.9SymbolsontheHeronandTransportCase

Symbol Description

Manufacturer’stradenameandaddress(ISO15223-1w)

Dateofmanufacture(ISO15223-1)

EquipmentPowerOn/Off(push/push)

USB plug

Warning,ConsultAccompanyingDocuments

Generalmandatoryactionmanual

Generalprohibitionindication

UserManualReference

DirectiveonWasteElectricalandElectronicEquipment

AuthorizedRepresentativeintheEuropeanCommunity

WarninglabelforLED

Non-ionizingelectromagneticradiation

Direct Current

Type(B)Levelofprotectionagainstelectricshock

Consultoperatinginstructionforuse.

EuropeanConformitymark

Prescriptionsymbol

Non-sterile(Scanner-Tips)

Usermanualsareavailableelectronicallyatthelinkprovided

��

��

EC REP

i3disc.com/support

i

8. Support, Warranty and Repair Service 8.1 Support

Ifyouhavequestionsaboutthesoftware,pleaseconsultthemanualandHelpmenuinthesoftware.Ifyouareexperiencingissueswithyoursoftware,pleasecheckthelistofcommonissuesprovidedinsection8.6priortocontactingadealer.Itcouldbesimplyaquestionofaminorissuethatcanbefixedquickly.However,ifyou’restillexperiencingproblemsafterfollowingtherecommendationsinthissection,thenpleasecontactthedealerwhereyouboughttheequipment.

8.2 Standard Warranty

3DISC warrants its non-consumable hardware products to be free from defects in materialsandworkmanship.Thewarrantycoversthecostofpartsandlabortorepairthe product.

Pleasekeeptheshippingcontainerforfutureuse.Productsreturnedtothefactoryforrepairshouldbeproperlypackaged.Toobtainwarrantyservice,followtheproceduredescribedintheRepairServicesection.Failuretodosowillcausedelaysandadditionalexpensetothecustomer.

Thewarrantyisvalidwhentheproductisusedforitsintendedpurposeanddoesnotcoverproductswhichhavebeenmodifiedwithoutwrittenpermissionfrom3DImagingandSimulationCorp.Americas,orwhichhavebeendamagedbyabuse,accidentorconnectiontoincompatibleequipment.Thiswarrantyisinlieuofallotherwarranties,expressedorimplied.

8.3 Repair Service

TheHeron™ IOScannotbe serviced locally. In theeventofahardwaremalfunction,contactyourdealertoarrangeforaswapunit(samemodelornewer)soyourunitcanbereplaced,andworkcancontinue.SometestingmightbeneededinordertoverifytheHardware/Softwareerrorormalfunction.

The company reserves the right to cease providing repair, maintenance, parts and technicalsupportforitsnon-consumablehardwareproductsfiveyearsafteraproductisdiscontinued.Technicalsupportforoldversionsofsoftwareproductswillcease12monthsaftertheyareupgradedordiscontinued.

8.4OutofWarrantyRepairService

Out of warranty repair service is available in selected geographical locations. Contactthesupplierforcurrenttermsandrates.

Issue RecommendationThere’samemoryfullerrormessagethatpopsupwhenthesoftwareisopen.

ClearsomespaceontheCDrive

ThestatusintheLiveviewwindowis“Disconnected”.

CheckthatyouhaveexternalpowertotheHeronandthattheUSBcableisconnected to a USB 3 Port.

Scanningisveryslow. CheckthattheLaptopisconnectedtoanexternalpowersource.

Thecornersarecutintheliveviewwindow.

CheckthattheTipiscorrectlymountedandwhenrotatingitislockinginplacewithaclick.

Thereisaredaquareinthescanwindow Gobacktoatooththatisscannedandstartfromthereagain

Noimagesappearwhenscannedbuteverythingelse(e.g.livewindowimage,sounds,FPS)worksfine.

Thescannermightneedtoberecalibra-ted.Pleasecontactyourlocaldealerforsupport.

TherearespotsontheLiveviewwindow. Checkandcleanthemirrorofthetip.

WherecanIgettheHeron™IOSsoftwareandmanuals?

PleasefindthemintheSupportsectionof3DISCwebsite.

WehopethisQuickGuidewashelpfultoyou.Foradditionalmaterialanduserinformationgoto3disc.com/support.

HeronIOSUsermanual

HeronIOSHow-toVidoesHeronIOSTrainingVideos

3disc.com/support

USA&Canada

3D Imaging and Simulations Corp. Americas365HerndonPkwy#18Herndon, VA 20170United StatesTel:+17034306080Tel:+18006700363(Tollfree)

Europe, Middle East&Africa

3DISC EuropeGydevang39-413450 AlleroedDenmarkTel:+4588276650

AsiaPacific&Australia

3DISC Asia#912,165,Magokjungang-roGangseo-gu,SeulRepofKoreaTel:+82261013110

Contact [email protected]

Contact [email protected]

EC REP

IOS-FPM-71-002-EN_JAN20