Table of Contents - ImageWorks · 2015. 4. 13. · 7 Chapter 1: Safety and Precautions 1.1 General...

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Chapter 1 Safety and Precautions ............................................................................................................71.1 General Safety Tips ...................................................................................................................71.2 Safety Symbols .........................................................................................................................8

Chapter 2 Introduction ...............................................................................................................................92.1 Intraskan DC X-Ray Equipment ..............................................................................................92.2 Indication for Use ......................................................................................................................92.3 This Manual ...............................................................................................................................92.4 Included System Components .................................................................................................10

Chapter 3 Know Your Intraskan DC ....................................................................................................... 113.1 KeyComponentsIdentification ................................................................................................ 113.2 System Labels ..........................................................................................................................123.3 Intraskan DC Reach Dimensions and Movements ...........................................................143.4 IntraskanDCWallmountConfigurations .................................................................................203.5 Keypad Console .......................................................................................................................243.5.1 Graphical LCD Display .............................................................................................................243.5.2 Keypad .....................................................................................................................................24

Chapter 4 Operating Intraskan DC ...........................................................................................................264.1 BeforeYouBegin .....................................................................................................................264.2 PositioningthePatient .............................................................................................................264.3 AchievingtheBestImageQuality ............................................................................................274.4 Power Turn-On Procedure ........................................................................................................284.5 IntraskanDCOperating Procedure Summary ..........................................................................294.6 ExposureSettingsandTables ..................................................................................................294.6.1 DefaultExposureProgramPresets ..........................................................................................294.6.2 Default Exposure Values ..........................................................................................................294.7 DeliveringanExposureProcedure ...........................................................................................29

Chapter 5 Using the Keypad Console .....................................................................................................345.1 SelectingaPresetMode ..........................................................................................................345.2 SelectingkV .............................................................................................................................345.3 ConfiguringDefaults.................................................................................................................355.4 Console Events ........................................................................................................................36

Chapter 6 Maintenance .............................................................................................................................376.1 CleaningandDisinfecting ........................................................................................................376.2 CaringForYourEquipment ......................................................................................................376.3 Shipping,LongTermStorageandTubeSeasoning .................................................................386.4 Preventive Maintenance ...........................................................................................................386.5 Disposal of the Unit ..................................................................................................................38

Chapter 7 Troubleshooting and Error Codes ..........................................................................................40

Chapter 8 Measurement Techniques .......................................................................................................41

Annex A: Technical Specifications .................................................................................................44Annex B: Declaration of Conformity ..............................................................................................48Annex C: Guidance and Manufacturer’s Declaration ...................................................................49Annex D: Contact Details ................................................................................................................52

Table of Contents

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Figure1 Intraskan DC Key Component Identification ......................................................................11Figure2 IntraskanDCLabelLocation ..............................................................................................14Figure3 WallMountedIntraskanDC15"SupportTubeFullyExtended RightSideandTopViews ..................................................................................................14Figure4 WallMountedIntraskanDC24"SupportTubeFullyExtended RightSideandTopViews ..................................................................................................15Figure5 WallMountedIntraskanDC33"SupportTubeFullyExtended RightSideandTopViews ..................................................................................................15Figure6 WallmounthIntraskan DC Ground Clearance & Horizontally Extended ...........................16Figure7 Wall mounth Intraskan DC Vertically Extended ..................................................................16Figure8 FloorMountIntraskanDCFullyExtendedDimensions .....................................................17 Figure9 FloorMountIntraskanDCSweepAngle ............................................................................17Figure10 FloorMountIntraskanDCExtendedDimensions ..............................................................18Figure11 FloorMountIntraskanDC-TopView ...............................................................................18Figure12 FloorMountIntraskanDC-StorageDimensions .............................................................19Figure13 IntraskanDCKeypadConsoleandWallMountingConfigurations ....................................20Figure14 Intraskan DC Keypad Console with LED display ...............................................................24Figure15 Doorbell switch ...................................................................................................................24Figure16 Remote Keypad Console ...................................................................................................24Figure17 HorizontalAngulation .........................................................................................................27Figure18 ParallelingTechnique .........................................................................................................28Figure19 Home Screen .....................................................................................................................30Figure20 HomeScreenwithSHighlighted .......................................................................................30Figure21 mAparametermodifiedandaccepted ...............................................................................30Figure22 X-Ray-Preparing ..............................................................................................................31Figure23 X-Ray-Exposing ...............................................................................................................31Figure24 X-Ray - Results ..................................................................................................................31Figure 25 Start-up Screen ..................................................................................................................34Figure 26 Home Screen .....................................................................................................................34Figure 27 Mode Selection Screen .................................................................................................................................34Figure 28 Automatic mode ..........................................................................................................................................34Figure 29 Manual mode .....................................................................................................................35Figure30 ConfigurationScreen ................................................................................................................................35Figure31 Stand-by Screen ................................................................................................................36Figure32 Error Display ......................................................................................................................36Figure33 kVFeed-backcircuit ..........................................................................................................36Figure34 Test points ..........................................................................................................................36Figure35 mAFeed-backcircuit .........................................................................................................36Figure36 Exposure time measurements ...........................................................................................36Figure37 kVmeasurementusingkVpsensor ...................................................................................36

FigureA-1 X-RayTubeInsertRatingChart .........................................................................................42FigureA-2 X-Ray Tube Insert Thermal Data .......................................................................................42FigureA-3 HeatingandCoolingCurve ................................................................................................43

List of Illustrations

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Table A Key Description ..................................................................................................................... 25Table1 DefaultExposureValuesforShort/LongConeR1(Film) ..................................................... 32Table2 DefaultExposureValuesforShort/LongConeR2 ................................................................ 32Table 3 Default Exposure Values for Short Cone R3 ........................................................................ 33Table4 DefaultExposureValuesforLongConeR3 ........................................................................ 33Table5 Attention/WarningMessages .............................................................................................. 36Table 6 Tubeseasoning..................................................................................................................... 38Table 7 Error Codes .......................................................................................................................... 39Table8 TroubleshootingTips ............................................................................................................ 40TableA1 Tube-HeadSpecifications .................................................................................................... 41TableA2 X-RayTubeInsertSpecifications ......................................................................................... 41TableA3 MechanicalDimensionsandWeight .................................................................................... 43Table A4 Mains Power Requirements ................................................................................................. 44Table A5 Environmental Conditions .................................................................................................... 44Table C1 Guidance and Manufacturer’s Declaration –

ElectromagneticEmissions–ForallEQUIPMENTandSYSTEMS .................................... 46Table C2 Guidance and Manufacturer’s Declaration –

ElectromagneticImmunity–ForallEQUIPMENTandSYSTEMS ...................................... 47TableC3 GuidanceandManufacturer’sDeclaration–ElectromagneticImmunity–

forallEQUIPMENTandSYSTEMSthatarenotLIFE-SUPPORTING ................................. 48

List of Tables

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This Page is left blank Intentionally.

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Chapter 1: Safety and Precautions

1.1 General Safety Tips

Radiation Safety ThisX-Rayequipmentmaybedangerous to thepatientand theoperatorunlesssafeexposureparametersandoperatinginstructionsareobserved.• FollowproperX-Rayradiationsafetyrules.• Do not allow non-prescribed exposures.• Thesystemshouldbeusedonlybydentistsortrained&qualifieddentalstaff.• AlwayspointtheX-Raytube-headattheareatobeimaged.• Patientsshouldbeprovidedwithleadapronandthyroidcollarwhilebeingexposed.• TheoperatorshouldwearproperX-Rayshieldingprotection.• The operator should be at a distance of at least 2 meters away from the tube-head

whilecarryingouttheprocedure.• The operator should not be standing in the direction of theX-Ray.The operator

should always stand away from the X-Ray beam and behind the tube-head.

Electrical Safety Alwaysswitchoffthemainpowerwhencleaninganddisinfectingtheunit.Theunit contains lethalhighvoltages.Donotattempt toopencoversor repair theunityourselforwiththehelpofnon-certifiedservicepersonnel.Contactyourauthorizeddealer.ThisisanORDINARYMEDICALEQUIPMENTwithoutprotectionagainstingressofliquids.Wateroranyotherliquidshouldbepreventedfromleakingintotheequipment,astheymaycause short circuit and/or corrosion.

Mechanical Safety Wherecompletesafeguardingoftheequipmentisnotpossible,duecaremustbetakentoensurethatnopartoftheuser’sorpatient’sbodyorclothingcanbetrappedorinjuredbyanypartoftheequipment.Inparticular,makesurethatfingersarenotcaughtorpinchedduringscissorarmmovement.

ElectromagneticInterference

Thisequipment complieswithEMI regulations. Interferencebetween theunit andothersensitive electronics can occur under extreme conditions. Do not use the X-Ray equipmentincloseconjunctionwithothersensitivedevicesordeviceswhichcreatehighelectromagneticdisturbance.

Physical Injury Exercise cautionwhenoperating themechanical scissor arm.Since thearmmechanismallowsfreemovementwithminimalforce,aswingingarmcaninadvertentlycauseinjuries.Theswingingjointsonthearmarepotentialpinchpoints.Usecautionwhileoperatingthearm.

Installation and Service

Installation and service of Intraskan DCmustonlybedonebyanauthorizedserviceengi-neer. Consult the factory or dealer as necessary.Make sure that Intraskan DC is assembled and installed in compliance with all applicable lawsandrecommendationsconcerningelectricalsafety.

Explosion Safety Thisequipmentmustnotbeusedinthepresenceofflammableorpotentiallyexplosivedisinfectinggasesorvapors,whichcouldignitecausingpersonalinjuryand/ordamagetotheequipment.Ifsuchdisinfectantsareused,thevapormustbeallowedtodispersebeforeusingtheequipment.Thisequipmentisnotsuitableforuseinpresenceofanaestheticgases.

• Usersmustexerciseeveryprecautiontoensurepersonnelsafety,andbefamiliarwiththewarningsandcautionspresentedthroughoutthismanualandsummarizedbelow.

• Make sure to read and understand the safety related instructions.• MakesurenottomodifyanycomponentoftheIntraskanDCsystem.Anymodificationmay result in violation of compliance to the standards. Imageworks shall not beresponsible for anymodification causing violation of compliance, compromise onsafety,performancedeteriorationoranyotheradverseeffects.

• Warrantyofthisequipmentwillbevoidintheeventofanymodificationdonetotheequipment,misuseoftheequipmentandopeningorservicingbyunauthorizedpersonnel.

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Chapter 1: Safety and Precautions

1.2 Safety SymbolsThefollowingsafetyrelatedsymbolsarefoundontheequipment.

Caution Symbol

This symbol indicates the user to be cautious and refer to the user manual for safe operatinginstructions.

Protective Earth Ground

MainsEarthGroundisrequiredforcontinuedprotectionagainstshockhazards.

Type of Insulation

Class1,TypeBInsulation.Protectionagainstelectricshock (UL60601-1:2003).RequiresprotectiveEarthConnection.

High Voltage

Dangerousvoltagespresent.

Caution: X-RayX-RaySourceAssembly /Tube-headcapableofgeneratingX-Rays.ThisX-Rayunitmaybedangerous topatient&operatorsunlesssafeexposure factorsandoperatinginstructionsareobserved.

WEEE Symbol Indicates that the unit conforms with WEEE Directive 2002/96/EC and must be disposed ofonlyattheappropriatefacilitiesforrecoveryandrecycling.

X-Ray Emission Status

X-RayEmission/ON

FocalSpot

MainsNeutralConnection

Mains Line Connection

FollowInstructionsforuse

Floor Mount CaremustbetakenforthemovementandpositioningofIntraskan DCFloorMount.

TheFloorMountsystemismeantforlimitedmovementinsidetheclinicandisnotsuitableforTransportapplications.Beforemoving theFloorMountsystemaround, thescissorarmsmustbefoldedtoavoidunnecessarydamagetothesystem.

Thewheellocksshouldbeunlockedbeforemovingthesystem.Afterthesystemisplacedatthedesiredlocation,thewheellocksshouldbeputinlockposition.

This equipment is meant for limited movement within a clinic or hospital room. Adequate careshouldbetakenwhilemovingonramporonanunevensurface.

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Chapter 2: Introduction

2.1. Intraskan DC X-Ray EquipmentThe Intraskan DC HighFrequencyIntraoralX-Rayhasbeenengineeredandmanufacturedtoprovidemanyyearsofreliable service.Thesystemhousestwomicroprocessors,oneforcontrol/supervisoryfunctionsandanothertoprovidetheuser/machineinterface.ThetechnologyincorporatesfeedbackcircuitstoensureaccuracyandreproducibilityofX-Rayoutputfordentaldiagnosticradiography.IntraskanDCwillcreateradiographsofexcellentquality,performingequallywellusinganyimagereceptor.The HighFrequencyIntraoralX-Ray is hereafter referred to as Intraskan DC in this manual. Review and follow the guidelinesincludedinthisUser'sManualtothoroughlybecomefamiliarwiththeoperatingandsafetyprocedures.ThiswillensurethatyourIntraskanDCgivesyouthehighestlevelofservice.

2.2. Indication for UseTheImageworksHighFrequencyIntraoralX-RayistobeusedasasourceofX-RaysinDentalradiography.Only trained professionalsshouldusethisdevice.Federallawprohibitsthesaleofthisdevicetoindividualsotherthantrainedprofessionals.Useofthisdevice,otherthanasdescribedinthismanual,mayresultininjury.

2.3. This ManualThismanualisnottobeusedasareplacementfortraininginradiography.The document contains basic operation instructions, identification of parts, system labels and safety guidelines for the Intraskan DC models listed below. Additionally,troubleshootingtipsareprovidedshouldtheequipmentnotperformasintended.Thefollowingareguidelinesforusingthismanual.

Alerts users to important instructions that require caution whenoperatingtheunitsince they are related to safety.

This symbol points to an important detail / tip in the operation of the unit. Read carefully to avoid any problems.

ThismanualdescribestheuserinterfaceofthekeypadConsoleusingimagesasshowntotheleft.Theseimagesareindicativeonlyandthevaluesdisplayedmaydifferfromtheactualvaluesunlessspecifiedotherwise.

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2.4. Included System Components

The Wall Mounted IntraskanDCsystemisavailableinthreemodelconfigurationsusingdifferentStraightArmassembly.

Top Level VariantsIntraskanDCIntraoralX-RayFloorMount

WallMountedIntraskanDCHighFrequencyIntraoralX-Raywith15"StraightArm



Unpack each component and verify that items listed below are received as appropriate. If any item is miss-ingordamaged,notifyyourauthorizeddealer.

Chapter 2: Introduction

Description Part No.

IntraskanDCHighFre-quency Intraoral X-Ray

(oneonly)

WallMounted15"StraightArmwithoutremoteswitch 9992720300



WallMounted15"StraightArmwithremoteswitch 9992720350



FloorMount 9992720100

ContentsNote: The Tube-head is shipped attached to the Scissor Arm

StraightArmAssembly forWallMount(oneonly)

15"Long SK-309-000422-0

24"Long SK-309-000423-0

33"Long SK-309-000424-0

ScissorArmAssembly(includescables) SK-309-000425-0

70kVp 8mA Tube-head Assembly SK-309-000426-0

Base Unit Assembly SK-309-000427-0

Exposure Switch with Cable SK-309-000428-0

TemplateforWallPlate(SingleStudMounting)Installations SK-207-001473-0

Intraskan DC Extension Cone SK-211-000317-0

16"WallPlatewithtemplate(Optional) 9992720002

RemoteKeypadConsolewithtemplate(Optional) 9992720003

DoorbellSwitchwithtemplate(Optional) 9992720001

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Chapter 3: Know Your Intraskan DC

3.1 Key Component Identification

AsshowninFigure1,IntraskanDCiscomprisedofthefollowingcomponents:1. Base Unit (Both Wall mount and Floor Mount Units) TheBaseUnitprovidesmountingsupportforthestraightarmandscissorarmwithattachedtube-head.It

provides system power connection and application via the Mains Power Line Cord and the Mains Power ON/OFFSwitch.Overall operational control for Intraskan DC is also provided via the Keypad Console.

2. Keypad Console (Both Wall mount and Floor Mount Units) The Keypad Console is the user/machine interfaceprovidingallfunctionaloperatingcontrolsoftheIntraskan

DCsystem.ConsistingofaLCDdisplayandkeypad,the console keypad allows both automatic and manual selections of exposure parameters while the resultant operation status is shown via the LCD display.

3. Straight Arm (Wall mount Units) TheStraightArmprovidesthehorizontalspaceawayfromthewall-mountedBaseUnit.Availablein15,24

and 33-inchlengthsto meet the reach requirements of the installation site.4. Scissor Arm (Both Wall mount and Floor Mount Units) TheScissorArmconsistsofaverticalandhorizontalarmjoinedviaadoublejoint.Thisdesignenablessmooth

linearandupwardmotiontransitionswhileallowingtheattachedtube-headtoremainbalancedinallpositions.

5. Mobile Support Platform (Floor Mount Units) TheMobileSupportPlatformprovidesastableportableoperatingbaseforIntraskan DC FloorMount6. Tube-head with Beam Limiting Device (Both Wall mount and Floor Mount Units) Provides 55 kV – 70 kV voltagerange(adjustablein1kVsteps)and 4 mA – 8 mA current range(adjustable

in1mAsteps)toreduce exposure times and the amount of radiation absorbed by the patient. The tube-headisequippedwithabeamlimitingdevicewitha220mmsourcetoskindistanceand60mmbeamdiam-eterat theoutput.The tube-head is connected to thearmbymeansofa rotatingcontact, allowing540degreehorizontalrotationand310degreeverticalrotation.

Figure 1. Intraskan DC Key Component Identification

Wall Mounted Intraskan DC Intraskan DC Floor Mount

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3.2 System LabelsThissectionshowstherequiredsystemlabelsthatareaffixedontheunit.RefertoFigure2forthelocationofeachlabelbythecorrespondingitemnumberbelowthelabel.

Illustration 3: Angular Tape (#15)

Illustration 5: X-Ray Control Console Label (#4)

Illustration 2: FDA Label (#2)

Illustration 8: Manufacturer Label (#7)

Illustration 1: Straight Arm Label (#1)

Illustration 4: Warning Label (#3)

Illustration 6: Danger Label (#5)

Illustration 7. X-Rays Caution Label (#6)

Illustration 9: System Label (#8)

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Illustration 18: Base Column Label (#18) Illustration 19: Casted Base Label (#19)

Illustration 17: Extension Cone Label (Optional) (#17)

Illustration 12: Base Unit Sl. No. Label (#10)

Illustration 10: 3rd Ed-UL Mark Label (#9)Illustration 11: Base Unit Label (#11)

Illustration 13: Tube Housing label for focal sport 0.5 (#12)

Illustration 14: Tube Housing Sl. No. Label (#13)

Illustration 16: L-Arm Dome Label (#16)

Illustration 15: Scissor Arm Label (#14)

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Figure2.IntraskanDCSystemLabelLocation(Refersection3.2,Page12forSystemLabels)

3.3 Intraskan DC Reach Dimensions and MovementsFigures3through12showminimumandmaximumclearances,dimensionsandsweepanglesforboththewallmount-edandFloorMountunits.

Figure3.WallMountedIntraskanDC15"SupportTubeFullyExtendedRightSideandTopViews


15Figure5.WallMountedIntraskanDC33"SupportTubeFullyExtendedRightSideandTopViews

Figure4.WallMountedIntraskanDC24"SupportTubeFullyExtendedRightSideandTopViews


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Figure7.WallMountedIntraskanDCVerticallyExtended

Figure6.WallMountedIntraskanDCGroundClearance&HorizontallyExtended


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Figure8.FloorMountIntraskanDCFully Extended Dimensions

Figure 9. FloorMountIntraskanDCSweep Angle

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Figure11.FloorMountIntraskanDC-Topview

Figure10. FloorMountIntraskanDCExtended Dimensions

Chapter 3 Know Your Intraskan DC

19

Figure12.FloorMountIntraskanDC-StorageDimensions


View A. Right Side View View B. Front View

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3.4 Intraskan DC Wall mount Configurations

Figure13:IntraskanDCKeypadConsoleandWallmountingConfigurations

Can use Internal Keypad Console and Internal Exposure Switch

RJ45(8P8C)withsingledoorbellswitchCanusebothKeypadConsoles(internalandremote)withInternalExposureSwitchandsingledoorbellswitch.

Note: (ForConfigurations2-7)

1. RJ45-8P8C 35' Cable: CAT-5 24AWG 4-Twisted Pair 1:1 Connection. Similar to BELDEN P/N 1624R

2. RJ11-6P4C 35' Cable: Center 4 Positions Populated 1:1 Connection. Similar to P/N A2521 #B

3. 3Wire, 35' Cable: Shielded or Un-shielded Cable AWG 20-28. P/N LAPP0028503

4. 2 Wire shielded or unshielded cable AWG 20-28 P/N LAPP0028502

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RJ45(8P8C)withDOUBLEDOORBELLSWITCHCanusebothKeypadConsoles(internalandremote)withInternalExposureSwitchanddoubledoorbellswitch

3WIREWITHSINGLEDOORBELLSWITCHCanuseInternalKeypadConsolewithInternalExposureSwitchandsingledoorbellswitch

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3 WIRE WITH DOUBLE DOORBELL SWITCHCan use Internal Keypad Console with Internal Exposure Switch and double door bell switch

RJ11(6P4C)WITHSINGLEDOORBELLSWITCHCanuseInternalKeypadConsolewithInternalExposureSwitchandsingledoorbellswitch

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RJ11(6P4C)WITHDOUBLEDOORBELLSWITCHCan use Internal Keypad Console with Internal Exposure Switch and double door bell switch

Intraskan DC Floor Mount unit is powered directly through a Hospital-grade Plug.For Intraskan DC Floor Mount unit, exposure is given using Internal Exposure Switch as in Wall Mount Configuration 1.

2 Stud Mounting

IntraskanDCWallmountingConfigurations

Single Stud Mounting

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3.5 Keypad ConsoleAllfunctionaloperatingcontrolofIntraskanDCisprovidedbythekeypadConsolelocatedonthebaseunit,consist-ingofaLCDdisplayandkeypad.Apartfromthis,RemoteKeypadConsole(ExternalConsolewithDoorbellSwitch)and Doorbell Switch also is available as an optional accessory. This additional console will be used for different configurationsofconsoleasillustratedinSection3.4.It allows both automatic and manual selections of exposure parameters.ThelocationofthepanelcontrolsandindicatorsareshownbyFigure14,whilethefunctionofeachisdescribedonthefollowingpage.3.5.1 Graphical LCD DisplayTheLCDdisplayonthekeypadConsoleoffersarichuserinterface,displayingtheselectedexposureparametersalongwithmanyotheruser-friendlyfeatures.ThescreencomponentsofthehomescreenareshownbyFigure14.

3.5.2 KeypadInadditiontotheLCDdisplay,thekeypadConsolecontains8keysandexposureLEDindicator.Thesekeysareusedto select the exposure parameters. Intraskan DC simplifiestheprocessofselectingexposureparametersusingpre-programmedsettingsforeverycombinationofimagereceptor,adult/childandtoothanatomyasdescribedbysection4.7,SelectinganExposuresetofthismanual.Additionally,anaudiblesignal(beep)soundstoconfirmkeypadbuttonselectionandwhencertainerrorsoccur.ThisalertisalsoheardduringanyX-rayemissionoccurrence.

Figure14.IntraskanDCKeypadConsolewithLCDDisplay

Figure 15. Door Bell switch

Figure 16. Remote keypad Console

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Exposure Status LED Indicator

NoColor:Idle/StandbyGreen:ReadytoDeliverX-RayOrange:ExposureinProgressRed:OperationFault

UP / DOWN Keys Navigateupordownalistmenu.Increment or decrement parameter value.

Seconds/milliampere

TogglesbetweenSecond/mATopLED:SecondBottomLED:mA

Adult / Child Preset Key

TogglesbetweenAdult&ChildPreset.TopLED:AdultBottomLED:Child

Canine/IncisorCanine/Incisor preset keyLEDON-EnableLEDOFF-Disable

BitewingBitewingpresetkeyLEDON-EnableLEDOFF-Disable

Pre-MolarPre-Molar preset keyLEDON-EnableLEDOFF-Disable

MolarMolar preset keyLEDON-EnableLEDOFF-Disable

Table A. Key description

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Chapter 4: Operating Intraskan DC

4.1 Before You Begin

Makesurethattheoperatorhasreadandunderstoodthismanualregardingoperationofthe system. Usersmustexerciseeveryprecautiontoensurepersonalsafety,andbefamiliarwiththewarningspresentedthroughoutthismanualandsummarizedinChap-ter1(Page7).Government regulators may require that only a licensed operator may use thisequipment.Checkwithyourdealerregardingregulations.

Regulator Approvals Installationanduseofradiationgeneratingequipmentisregulatedbythegovernmentor itsauthorizedagencies inmostcountries.Checkwithyour localdealerregardingsiteapprovalsorusagerequirements.

The operator should be well acquainted with the radiation protection methods for both the operatorandpatientbeforeusingthisequipment.

Film DevelopmentMajorityofrepeatexposuresandinferiorX-Rayimagesareattributedtothestorage,handling,useanddevelopingofX-Rayfilmsrather than theequipment itself.Makesurethattheimagecapturefilmsarestoredandusedperinstructions.

Letthepatientknowthathe/sheisgoingtobeexposedtoX-Ray.AvoidX-RaysortakenecessaryprecautionswhenX-Rayingpregnantpatients.

4.2 Positioning the Patient

AdultsThe patient shall be seated and made comfortable so that he/she does not move duringtheexposure.Makesuretoplaceprotectiveapronsandshieldsoverthepatientwhere necessary.

Children Foryoungpatients,itmayberequiredthataguardianbeavailablenearthepatient.Insuchcases,instructtheguardiantobeonthesamesideoftheX-Rayport;awayfromtheX-Raybeamandbehindthetube-head.Theguardianshallwearradiationprotectiveclothing.

Position Indicating Device

ThePositionIndicatingDevice(PID),alsoreferredtoastheCone,shouldbeusedtoapproximate the area of X-Ray exposure.

The tube-head has an built-in focus to skin distance of 220mm ± 5mm. This is also referred as short cone distance,which is the safe distance at which the skin can be positioned.Optionally, the operator can use long cone. Long cone will increase the focus to skin position distance from 220mm ± 5mm to 300mm ± 5mm

27


4.3 Achieving the Best Image QualityIntraskan DC is engineered to provide thebest platform for dental radiographic imaging. However, thebest resultsareobtainedwhentheequipmentisusedproperlyperthemanufacturer'sspecifications.Practicingthefollowingpositioningtech-niques will help the user make the best out of the equipment’s output.

Patient's Head Position Patient’sheadshouldbeasstraightaspossible. Thepatientshouldnotmoveduringtheexposure.

Cone Position Cone should be positioned in such a way that the central axis of the cone is perpendicular to the teeth and

shouldbeasclosetotheareabeingimagedaspossible. Ingeneral, theverticalangulationoftheconeshouldbeat+45°formaxillateethand-10°forMandible

teeth. Thehorizontalangulationoftheconeshouldalsobemaintainedtoachieveperpendicularitywithrespect

totheteethasshownbyFigure17below.

The angle of the cone is indicated on the scale located on the vertical joint of the tube-head.

Figure17.HorizontalAngulation

M – Molar P – Pre-Molar C – Canine

MaxillaML

0°

C

P

M80-90°

60-75°

70-80°

Sagittal Plane

MandibleSagittal Plane

C

P

M80-90°

45°70-80°

0°

ML

28

Image Receptor Holder Usinganimagereceptorholderandheadpositioningdeviceisrecommendedsinceitgivesprecisecontrolover

theareatobeimaged.

Placement of Image Receptor Inside the Patient's MouthThe imagereceptorshouldbeplacedparalleltothelongaxisoftheteethasshownbyFigure18.

CR Central Ray: an imaginary beam of X-Rays in the exact center of the position indicating device.

Film parallel to long axis of tooth

CR perpendicular to long axis of tooth & film

Long axis of tooth

CR


The Image Receptor and holder are not part of supplied accessories.

Figure18.ParallelingTechnique

4.4 Power Turn-On ProcedureTurnonIntraskanDCbyperformingthefollowingsteps:

1. PlacetheMainPowerSwitchlocatedonthebottomoftheBaseUnittotheON(I)posi-tion.SeeFigure1.(Page11)

2. Onpowerup,observe that the system self check function initiates and the console dis-play'sStart-upScreenasshownbyFigure25(Page34).

3. Immediately following a successful self test, the console displays a home screen asshownbyFigure19(page30).

Refer to Chapter 5 for details on navigating the Keypad Console for setup and operation of Intraskan DC

Do not press any keypad keys during self test period. Any input will be considered an error at this time.

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4.5 Intraskan DC Operating Procedure Summary1. TurnonIntraskanDCbyperformingthePower Turn-On Procedure provided in section 4.4.2. Introducethereceptorintothepatient’smouthaccordingtothechosentechniqueasshownbyFigures17

and18(bisectingorparallel-Page27,28).3. Move the tube-head beam limiter near the patient and direct it exactly towards the tooth to be examined.4. Arrangethetube-headwithananglesuitablefortherequiredexposureandpositioning.5. MoveasfarawayastheExposureswitchcableallows,inadirectionoppositetotheX-raybeamemission

whilemaintainingvisualcontactwiththekeypad Console and the patient.

Refer to Tables 1 through 4 (Page 32 to 33) for estimated exposure values of minimum patient dose that can be modified per user requirement in Custom mode.

6. CreateanexposurebyperformingtheExposure Delivery Procedure provided in section 4.7. MakesuretorefertoChapter5fordetailsonnavigatingthekeypadConsoleforsetupandoperationof

Intraskan DC as necessary.

4.6 Exposure Settings and Tables

4.6.1 Default Exposure Program PresetsBy default the keypad console boots intoR1,Shortcone,Adult,Canine/IncisorPresets.Thedefaultorstart-upex-posureprogramistheexposureprogramsettooperateIntraskan DC upon power turn-on of the unit. The default exposureprogramcanbechangedusingthekeypadConsolebyperformingtheSettingaPresetastheStart-upModeprocedure provided in section 5.2

4.6.2 Default Exposure ValuesEstimatedexposurevalues(kV,mA&S)listedbyTables1through4(Page32to33)areforminimumpatientdoseandcanbemodifiedperuserrequirementlater.RefertothetablesbelowforDefaultExposureValuesforspecificIntraskan DC application modes and options.

Table1.DefaultExposureValuesforShort/LongConeR1(Film)

Table2.DefaultExposureValuesforShort/LongConeR2(Custom)

Table3.DefaultExposureValuesforShortConeR3(Custom)

Table4.DefaultExposureValuesforLongConeR3(Custom)

4.7 Exposure Delivery ProcedureThemomentthekeypadconsoledisplaystheHomescreen,theunitisreadytodeliveranexposure.Thissectionde-scribesthepreparationsthatcanbedonebeforedeliveringanexposureandwhathappensduringtheprocedure

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Figure19. Home Screen

Bringtheconsolebacktohomescreenasshowninfigure19.Here theusercanmodify themA,andSvalueThedefaults (kV,Cone,andPresetmode)canbesetduringConfigurationtime(SeeSection5.3).

Selecting an Exposure Set proceed as followsAn exposure set is a combination of patient type and tooth anatomy which the console uses as an indextoretrievetheexposureparameters.Foreachmode,thereare8presetsavailable.Toselectonefromthese8exposureset,usethepatienttypekeyandthetoothanatomykeys.e.g.totakeX-Rayimageofcanineofachild

1. Press the ADULT / CHILDkeytoselectchild(bottomLED),2. Press the CANINE key until the LED is turned on.

Modifcation of mA & S values proceed as follows

Figure 20. Home Screen with S

highlighted

Highlight the parameter Bydefaultparameter'S'isHighlighted(S/mA)

IfvaluesofmAisHighlighedandtobealtered,changethevaluesbyusingUp&Downkeys.IfvaluesofStobealtered,selectbypressing(S/mA)untilthepa-rameterisHighlighedandchangeusingUp&Downkeys.

Modify the parameterPress UP / DOWNkeystherequirednumberoftimestochangethehighlightedparameter.Theparameterbeingchangedtoindicatetheoperation.

Figure21.mAparametermodifiedand accepted

Accept the changeThe set parameters are accepted automatically.

31


Figure 22. X-Ray - Preparing

Now pressExposure Switch or Remote Exposure Button on the Doorbell switch to initiate the exposure.Heretheunitpreparesitselftodelivertheexposure.Thisstagemighttake a few seconds. Verify that an audible beep occurs and the X-Ray statusindicationLEDilluminatesgreen.StoporabortanexposurebysimplypressinganykeyotherthantheExposure Switch.

The Exposure Switch must be kept depressed throughout the entire exposure. Releasing the Exposure Switch before the end of the exposure terminates the emission with the messagedisplaying "X-RAY ABORTED" .

Figure 23. X-Ray - Exposing

Verify that an audible beep occurs and the screen shows the radia-tion iconwhile theexposure isbeingdelivered.TheX-RaystatusindicationLEDalsoilluminatesorange.

If you need to abort while delivering an exposure, simply release the Exposure Switch.

Figure 24. X-Ray - Results

Oncetheexposureiscompleted(orabortedwhiledelivering),theX-RayresultsscreendisplaystheactualvaluesofkV,mAandSsensed.

The Exposure Switch may be released once the X-Ray Results screen displays.IftheExposureSwitchiscontinuedtobeheld,thenextexpo-sure will not be initiated.

Results screen would show ABORTED rather than DONE when the exposure procedure was aborted.

The results screen is shown for 5 seconds if not interrupted by any key press(excepttheExposureSwitch).ThescreenreturnstoHomescreenand is ready for the next exposure.

The tube-head needs to cool down before proceeding to the next exposure. This waiting period depends on the specific exposure duration selected for the last exposure. If an attempt is made to conduct an exposure during this waiting period, the console displays a message requesting the operator to wait for the remaining amount of time required by the tube-head to cool down.

32

Table1.DefaultExposureValuesforShort/LongConeR1(Film)

Validated Exposure Values (kV, mA & S) mentioned below are for minimum patient dose and can be modified as per user requirement.

Anatomy kV mA

Time (S)

Slow FastCone

Short Long Short Long

Adult

Bitewing 70 8 0.09 0.27 0.07 0.22

Canine 70 8 0.14 0.44 0.11 0.35

Molar 70 8 0.16 0.49 0.13 0.39

Pre-Molar 70 8 0.14 0.44 0.11 0.35

Child

Bitewing 70 8 0.07 0.19 0.05 0.13

Canine 70 8 0.1 0.31 0.08 0.22

Molar 70 8 0.12 0.34 0.09 0.24

Pre-Molar 70 8 0.1 0.31 0.08 0.22

Table2.DefaultExposureValuesforShort/LongConeR2(Custom)

Estimated Exposure Values (kV, mA & S) mentioned below are for minimum patient dose and can be modified as per user requirement.

Anatomy kV mATime (S)

ConeShort Long

Adult

Bitewing 70 8 0.07 0.22

Canine 70 8 0.11 0.35

Molar 70 8 0.13 0.39

Pre-Molar 70 8 0.11 0.35

Child

Bitewing 70 8 0.05 0.13

Canine 70 8 0.08 0.22

Molar 70 8 0.09 0.24

Pre-Molar 70 8 0.08 0.22


33

Table3.DefaultExposureValuesforShortConeR3(Custom)



ConeShort

Adult

Bitewing 70 8 0.15

Canine 70 8 0.13

Molar 70 8 0.15

Pre-Molar 70 8 0.13

Child

Bitewing 70 8 0.11

Canine 70 8 0.11

Molar 70 8 0.12

Pre-Molar 70 8 0.11

Table4.DefaultExposureValuesforLongConeR3(Custom)



ConeLong

Adult

Bitewing 70 6 0.33

Canine 70 8 0.25

Molar 70 8 0.25

Pre-Molar 70 8 0.25

Child

Bitewing 70 8 0.18

Canine 70 8 0.18

Molar 70 8 0.18

Pre-Molar 70 8 0.18


34

Figure 27: Mode Selection Screen

Mode Selection ScreenGotoConfigurationmenuasexplainedinSection5.3.Use the UP/DOWNkeystonavigatewithinthelist.PressthesebuttonsuntilthedesiredmodeishighlightedSelectSetExposureModebypressingS/mA key. A screen similar to the one shown on the left side appears on the display.UsercanselectonemodeamongthesebypressingS/mA key. BypressingAdult/Child key to returns home screen with the newly se-lectedmodeabbreviatedonthetoprightsideofthedisplay.

Chapter 5: Using the Keypad Console

ThekeypadConsoleistheuserinterfaceallowingtheoperatortocontroltheX-Raysystemandgetfeedbackfromit.Thissectiondescribeshowtousetheconsoletocompletespecifictasks.Asapreface,thestagesthroughwhichtheconsolepassesbeforeitbecomesoperablearedescribedfirst.

Figure 25: Start-up Screen

Power up - IndicationOnpowerup,theconsoledisplaystheStart-upScreenasshownontheleft.Followingthis,theconsoleperformsselftest.Thekeypad,beeper and LCD backlightarechecked.Do notpressanykeys(includingexposureswitch)duringselftestperiod.

Figure 26: Home Screen

Home ScreenImmediately followingasuccessfulself test theconsoledisplaysascreensimilar to the one shown on the left. This screen displays current selection ofexposureparameters,exposuremodedetailsandaccessoriesselected(conetypeandfilmspeed).

A'READY'iconatthetoprightcornerofthedisplayindicatesthatthesys-tem is ready to deliver an exposure.

5.1 Selecting a Preset ModeAPresetModeisacollectionofexposureparameters(kV,mAandS)suitableforaparticulartypeofimagerecep-tor. The keypad Console of Intraskan DCprovidesatotalofthreeusermodesofoperation,whichinclude:

Onefactoryprogrammeddefaultmodes,R1(Film) Twocustommodes:R2&R3

Each mode provides 8 sets of exposure parameters based on the patient type and tooth anatomy. Thefactoryprogrammedmodesvariestheexposuredurationtosuitetheaccessories(conetypeandfilmspeed)se-lected.ChangethePresetModebyperformingtheprocedureprovidedbelow.

5.2 Selecting kVkVcanbemodifiedonlyinManualmode.To set Automatic mode proceed as follows.

Figure 28 : Automatic mode

GotoConfigurationmenuasexplainedinSection5.3.Set Select kV optioninConfigurationmenubyusingS/mA key. In Select kV asshowninfigure28,setAutomaticmodebypressingS/mA keyInAutomaticmode,usercannotmodifythekVvalue.

35

Figure 29 : Manual mode

To modify kV values in manual mode proceed as follows.GotoConfigurationmenuasexplainedinSection5.3.Set Select kV optioninConfigurationmenubyusingS/mA key. In Select kV asshowninfigure28,setmanualmodebyusingS/mA key.Use Up/Down key to select the required kV and setkVvalue,bypressingS/mAkeyasshowninfigure29.


5.3 Configuring DefaultsTosettheparameterslikekV,modesandconeasrequired,proceedasfollows.PressUpandDownkeysimultaneouslytoaccessconfigurationmenu(duringstartuplogo)

Theusercanset/accessthefollowingoptionsasshownintheFigure30

Use Up/DownkeytonavigatewithinConfigurationmenu. Press S/mAkeytoacceptcurrentlyhighlighteditem. Press Adult/Child key to return previous menu.

Figure30:ConfigurationScreen

36


5.4 Console EventsThissectiondescribesthespecialeventsdisplayedintheKeypadconsole.ForAttention/Warningmes-sages,referTable5andforerrorcodesreferTable7.

Figure 31. Stand-by Screen

InactiveAbsence of any activity for 10 minutes continuously on the console causesthesystemtogotoastateofinactivity.Thisismarkedbythescreen indicatingamessageasshownonthe leftsidealongwiththedisplaybacklightdrivenintoa‘breathing’state.PressanykeytobringtheconsolebacktotheHomescreen

Figure 32. Error Display

ErrorAnyerroroccurring in thesystem is reportedby theconsoleasfollows.• Displaysanerrormessagewithanerrorcodeandadditional

messages(examplecodeshownisCN009).• DisplaybacklightturnsRED• Anexposurecannotbedelivereduntiltheissueisresolved.

Attention/WarningMessages Screen Condition

Tube coolingPlease wait<n> seconds

Home EXPOSURE key pressed after an exposure andbeforethecoolingperiodexpires.

System error.<error code>Please retry

Home Afterfixinganinternalerrorwhileexposing.

ERROR<error code>Please restart

Home After an internal error that requires user / service intervention.

Table5:Attention/WarningMessages

37

Cleaning Methods. Inordertoensureproperhygiene,especiallywhenprotective barriers are not used between each patient,clean and disinfect Intraskan DC by thoroughlyperformingthefollowingprocedures:

Important: Makesurethattheunitiscompletelydrybeforeplugginginorturningpower back on.

Exterior Surfaces: Wipe the outside surfaces with a disposable towel moistened with water. Dry the external surface with disposable towels. Parts in Contact with the Patient’s Skin:Toensurepropercleaningoftheseparts,periodicdisinfectionwithanapprovedEPANonCorrosiveSurfaceDisinfectantisrecommended.Cleananyremainingdisinfectantresiduefromthe system with a disposable towel moistened with water.

6.2 Caring For Your Equipment Do not allow the unit to impact with any hard surfaces. Switchofftheunitwhenleavingforthedayorwhennotusedforalongtime. Ensurethattheunitisnotsubjecttodirectsunlight. Donotforcethearmmechanismsortube-headintoapositionitisnotdesignedfor.Therearemove-

ment stoppers provided. Avoidswingingthearmsorrotatingthetube-headinasuddenjerkymanner. Avoidfreeswingingofthearmsortube-head.Alwaysguidethemovementswithyourhand. Donothangexternal loadsorweightsonthetube-headorStraightArm.Thearmandbaseunitsare

designedforitsownweightandmaynotholdanadditionalweight. Schedule and carry out periodic maintenance checks.

Chapter 6: Maintenance

• Useasoftdampclothtocleantheoutsidesurfacesoftheequipment

• Donotsprayorletthecleaningfluidentertheunit.

• Periodicdisinfectingoftheunitisrequiredforhygiene.Disinfectwithacompatiblelow or intermediate level instrument grade disinfectant after cleaning.

• Useanon-acetonebaseddisinfectantliquid.

6.1 Cleaning and Disinfecting

Important: TurnOFFIntraskanDCWallmountorturnOFFandunplugthe Intraskan DC FloorMountUnit. Waitfor2minutesbeforeproceedingwithservice.Active internal circuits remain connected tomainvoltageevenwhenmainpowerswitchisturnedoff.

38

Chapter 6: Maintenance

6.3 Shipping, Long Term Storage and Tube seasoning Usetheoriginalpackingboxforshipping/transportingtheunit. Whennotusingforalongtime,covertheunitwithdustproofcoversandensuretheunitisnot

exposed to harsh environments. Incaseofnon-usageforlongperiod(>6months)X-RayTubeSeasoningisrecommended.

Cover theX-RayportwithLead .Using theKeypadConsoleset theparametersperTablebelow.GiveExposureandrepeatexposure5timesforeachcombinationofkV,mAandS.Afteralltheexposuresarecompleted,theUnitisreadyforuse.

kV mA Time(S)55 4 0.04

55 6 0.04

55 8 0.04

55 4 0.50

55 6 0.50

55 8 0.50

60 4 0.04

60 6 0.04

60 8 0.04

60 4 0.50

60 6 0.50

60 8 0.50

70 4 0.04

70 6 0.04

70 8 0.04

70 4 0.50

70 6 0.50

70 8 0.50

Table6:

6.4 Preventive Maintenance Forcontinuedservicesupport,ensureyouhaveenteredintoanannualmaintenanceprogramwith

yourdealer.Thiswillensurethatqualifiedengineersperiodicallykeepacheckontheequipment. Itisadvisedthattheunitbesubjecttoamaintenancescheduleonceeveryyear(after1styearof usage). Allservicingshouldbedonebyqualifiedpersonnel.

The interior of the Main Assembly is only accessible by removing hardware with tools and should only be opened and serviced by an authorized ImageWorks’ Dealer Service representative. Call your authorized Imageworks’ dealer for service. Since the interior of the unit contains high voltage com-ponents,failuretoheedthiswarningmayresultinequipmentdamage,personalinjuryand/ordeath.

6.5 Disposal of the UnitSomepartsoftheequipmentcontainmaterialandfluidswhichmustbedisposedofatappropriaterecyclingcentersconformingtoalllocal,stateandfederalregulations.Inparticulartheequipmentcontainsthefollowingmaterialsandorcomponents:

Tube-head:externalpackagesinnon-biodegradableplastic,dielectricoil, lead,copper,brass,aluminium,tungsten.

Power supply and remote control:externalpackagesinnonbiodegradableplastic,iron,populatedprintedcircuitboards,copper.

Tube-head extension:iron,aluminium,copper&siliconrubber.Important: The Manufacturer and the Distributor do not accept any responsibility for the disposal

of equipment or parts discarded by the user and the related costs.

39

Table 7. Error Codes

Error Code Error

CN001 Communication error

CN002 Console and tube-head are incompatible

CN003 X-Ray preparation time-out

CN004 Anode arc fault

CN005 Cathode arc fault

CN006 Over kV fault

CN007 Over mA fault

CN008 kVregulationfault

CN009 Filamentopenfault

CN010 Filamentlimitfault

CN011 CANfault

KB001 Keyjamerror

Chapter 7: Troubleshooting & Error codes

Intraskan DChasbeendesignedwithsafetyfeaturestoprotectthepatientandoperatorincaseoffailureofanelectrical component. The system automatically checks for errors and will report a malfunction by means of an error code on the Keypad Console display. These error codes are listed in the Table 7 below. The table lists the codeand identifies thecorrespondingequipmentoperational fault.Thecorrectiveaction for theerrorcode isprovidedbyTable8,whichalsolistsobservedproblemsandtheirpotentialsource.

40

Table8.TroubleshootingTips

Observed Problem Recommended Action

1. Errorstatewithdisplay indicatingCNXXX error code

Switch off mains power. Wait for 2 minutes and then Switch on mains power. Iftheproblempersists,contactauthorizedservicepersonnel.

2. Errorstatewithdisplay indicatingKB001 error code

Ensure none of the console keys are active.Switch off mains power. Wait for 2 minutes. Switch on mains power and make sure that none of the console keys are pressed.Iftheproblempersists,contactauthorizedservicepersonnel.

3. The unit does not power on when mains is switched on.

Check for loose contact at the wall socket end.Orthewalloutletisnotreceivingpower.Checklocalelectricalcircuitfor trips.Switch off mains power. Wait for 2 minutes. Switch on mains power.Iftheproblempersists,contactauthorizedservicepersonnel.

4. NoX-Rayimageeventhroughtheunit indicates normal exposure

Verify filmdevelopmentandstoragemethod.Thefilmscouldbedamagedorthechemicalscouldbecontaminated.Contact authorized service personnel to validate exposure quality.

5. The mechanical Straight Arm isdrifting and does not stay in setposition.

Thiscanbeduetonormalwearandtearorusingexcessforceonthe arms. Getthespringtensionadjustedbyanauthorizedserviceengineer.Contact authorized service personnel.

6. Poorimagequality Pleasemakesurethatfollowingpointsareobserved.

• Correct exposure values are selected for the anatomy.

• Whenusingfilmasimagereceptoritsstorageandprocess-ingareasrecommendedbythemanufacturer.

• Positioningoftube-headandreceptorisproper.

• Patientispositionedstablyduringimaging.Iftheproblempersists,contactauthorizedservicepersonnel.


Table8providestroubleshootingtipstohelptheuserrecoverfromanequipmentfaultcondition. It lists observed problems as well as recommends the corrective actions.


41

Chapter 8: Measurement Techniques

8.1 Direct measurement method

Instruments used in kV, mA and timer accuracies measurement

S/N Description Make Model Remarks01 DSO, 200Mhz YOKOGAWA DLM2024 AnyEquivalentequipmentcanbeused(with

valid calibration)


Abbreviations used:kV=Tubepotential,mA=Tube Current S= Exposure timeDSO=Digitalstorageoscilloscope

Tube Potential testing method:

TubepotentialmeasurementisdirectmethodbyusingpotentialdividerandDSOasshownbelow.PotentialdividerisinbuiltintotheINTRASKANDCandmeasurementpointTP2onthecontrolboard(referfigure34)providedforhookingmeasuringprobe.

Test procedure:(Productiontestwillbeperformedwithnominalinputvoltage110Vac,60Hz.)

1.ConnecttheprobeoftheDSOtoTP2(kVfeedback)withrespecttoground(mountingscrew)ofcontrolboardasshownintheFigure34.

2.SwitchONtheACmains.IndicationonControlboard:ThefaultLEDD10ontestcontrolboardshouldnotglowred.TheLEDD7ontestcontrolboardshouldglow(greencolor)andtheLEDD6(greencolor)ontestcontrolboardshouldbeblinkingevery1sec(approx).IndicationonConsoleboard:[Note:DonotpressanykeywhenconsoledisplaysthemessageSELFTEST]AllLED’sshouldglowduringselftest&LCDwilldisplayall3(Red,Green&Blue)coloursinsequence.Consoleshouldbootintothehomescreenwithoutdisplayinganyerrormessage.

3.CommandexposuresthroughoperatorconsolewithkV,mAandSsettingsshownintablebelow.Press&holdexposurebuttontillexposuredonesignalcomesintheLCDdisplay.MeasureandRecordthevoltageonOscilloscope.Tubepoten-tialsignalmeasuredfromDSOaremultipliedbyDesignfactor80/6.Eachmeasuredtubepotentialisverifiedwithrejectionlimit.

Figure 33. kV Feed back circuit Figure 34. Test Points

42


Tube kV Tube Current, Exposure Time55, 60, 65, 70. 4mA, 0.04s 4mA, 4s 6mA, 0.04s 6mA, 4s 8mA, 0.04s 8mA, 4s

4.Rejectionlimit: Design:3%. TobemeasuredbyaDSOhavingaccuracy<±2%. DifferencebetweenkVCommandtokVactualshallbe<±5%

Tube Current testing method :

Tubecurrentmeasurementisdirectmethodbyusingshunt/Sensingresistor,750Ohms,+/-1%andDSOasshownbe-low.CurrentsensingcircuitisinbuiltintotheINTRASKANDCandmeasurementpointTP5providedforhookingmeasur-ingprobe.

Test procedure:(Productiontestwillbeperformedwithnominalinputvoltage110Vac,60Hz).

1.ConnecttheprobeoftheDSOtoTP5(mAfeedback)withrespecttoground(mountingscrew)ofcontrolboardasshownintheFigure34.

2.SwitchONtheACmains.IndicationonControlboard:ThefaultLEDD10ontestcontrolboardshouldnotglowred.TheLEDD7ontestcontrolboardshouldglow(greencolour)andtheLEDD6(greencolour)ontestcontrolboardshouldbeblinkingevery1sec(approx).IndicationonConsoleboard:[Note:DonotpressanykeywhenconsoledisplaysthemessageSELFTEST]AllLED’sshouldglowduringselftest&LCDwilldisplayall3(Red,Green&Blue)coloursinsequence.Consoleshouldbootintothehomescreenwithoutdisplayinganyerrormessage.

3.CommandexposuresthroughoperatorconsolewithkV,mAandSsettingsshownintablebelow.Press&holdexpo-surebuttontillexposuredonesignalcomesintheLCDdisplay.MeasureandRecordthevoltageonOscilloscope.TubecurrentcalculatedfromDSOsignalmultipliedbyscalingfactorof(8/6).MeasuredTubecurrentreadingareverifiedwithrejectionunit.

Tube current loading (mA)

kV, S

4, 8 55, 0.04 55, 4 70, 0.04 70, 4

4.Rejectionlimit: Design:3% TobemeasuredbyaDSOhavingaccuracy<±2%. DifferencebetweenmACommandtomAactualshallbe<±5%

Exposure time test method:ExposuretimemeasurementisdirectmethodbyusingDSOasshownbelow.ExposuretimeismeasuredacrosstestpointsTP2andGround(Chassis).TheexposuretimeisthetimemeasuredbetweenstartofkVwaveformandstartoffallingedgefromFinalValue.

Figure 35. mA Feed back circuit

43


Eachmeasuredvalueisverifiedwithrejectionlimit.

kV mA S70 8 0.04, 0.40, 2, 4

Rejectionlimitset+/-10%ofsetexposuretime

Test procedure:

1.ConnecttheprobeoftheDSOtoTP2(kVfeedback)withrespecttoground(mountingscrew)ofcontrolboardasshownintheFigure34.

2.SwitchONtheACmains.IndicationonControlboard:ThefaultLEDD10ontestcontrolboardshouldnotglowred.TheLEDD7ontestcontrolboardshouldglow(greencolour)andtheLEDD6(greencolour)ontestcontrolboardshouldbeblinkingevery1sec(approx).IndicationonConsoleboard:[Note:DonotpressanykeywhenconsoledisplaysthemessageSELFTEST]AllLED’sshouldglowduringselftest&LCDwilldisplayall3(Red,Green&Blue)coloursinsequence.Consoleshouldbootintothehomescreenwithoutdisplayinganyerrormessage.

3.CommandexposuresthroughoperatorconsolewithKv,mAandSsettingsshownintablebelow.Press&holdex-posurebuttontillexposuredonesignalcomesintheLCDdisplay.MeasureandRecordthetimeonOscilloscope.%ofErroriscalculatedbetweensettime(command)andmeasuredtimeas%Error=((Measuredtime-SetTime)/Settime)x100%Example: % Error with 0.04S exposure time= ((0.0398 - 0.04) / 0.04) x 100 = -0.005 x 100 = -0.5%

8.2 Indirect Measurement method:

S/N Description Make Model Remarks01 Accu-pro Radcal 9096 AnyEquivalentequipmentcanbeused

(withvalidcalibration)02 Kvp sensor Radcal 40×12-WTest Procedure:Place the kVp sensor at 25cm from the focal spot. Visually center the kVp probe in the x-ray beam path such that the beamwillstrikesensorintheprobeasshowninthepicturebelowOncealigned,deliveranexposure(protocol:70kV,8mA,0.04S)andcapturethewaveformintheoscilloscope.

Acceptancecriteria:NoovershootinthekVwaveform

Figure 37. kV measurement using kVp sensor

Figure 36. Exposure Time measurement

44

Annex A: Technical Specifications

TableA1.Tube-headSpecifications

Description Specification

Generator Type HighFrequency,MicroprocessorControlled,ConstantPotential(DC)

Control of High Voltage Closed Loop

High Voltage Range 55kV–70kVSettable(Stepsize1kV)

Accuracy of High Voltage <±5%

High Voltage Ripple Frequency >200kHz

High Voltage Ripple LowFrequencyRipple(≤10kHz)shallbelessthan2%ptopmeasured@70kV/8mAHighFrequencyRipple(≤50kHz)shallbelessthan10%ptopmeasured@70kV/8mA

High Voltage Rise Time <3ms

Control of Tube Current Closed Loop

Tube-head current range 4mA–8mASettable(Stepsize1mA)

Accuracy of current <±5%

Maximum Exposure Time 4 seconds

Minimum Exposure Time 0.04 s

Exposure Timer Accuracy <±10%

Maximum Electrical Input 560Wat70kV,8mA

Duty Cycle 1:15Adaptive&autolimitbasedontemperature.

Additional X-Ray filtration Minimum2.0mmAlequivalent@70kV

Total X-Ray filtration >2.5mmAL/70kV

Minimum source to skin distance

220mm±5mm(in-built) 300mm±5mmwithoptionalcone

X-Ray field (at collimator tip) Circular,diameter≤60mm@SSDof220mmand300mm

Leakage radiation @ 1m <0.88mGy/h(100mR/h)

Leakage radiation technique 70kV,8mA,1s

Tube-head Outer Covers PCABSPlasticwithGlossyFinish

PID / Cone Material/Exten-sion Cone Silicone Rubber/Aluminium/ Markrolon - 2407

TableA2.X-RayTubeInsertSpecifications

Parameters Specification

Tube Insert Model OX/70-5

Focal Spot (IEC60336) 0.5

Anode material Tungsten

Anode angle 19°

Insert Inherent filtration 0.5mmAlequivalent@70kV

Anode thermal capacity 7 kJ

45

FigureA-2.X-RayTubeInsertThermalData


FigureA-1.X-RayTubeInsertRatingChart

46

FigureA-3.HeatingandCoolingCurve

TableA3.MechanicalDimensionsandWeight

Description Comment/Value

TotalWeightofSystem(includingPackingCarton)

Wall Mount 15"StraightArm-86lbs24"StraightArm-90Ibs33"StraightArm-95lbsFloorMount-223lbs

WeightofTube-head 11.023lbs(Approx.)

StraightArmMaterial Aluminum

Typeofpainting Glossy

Mountingtype BaseUnitadaptersforWallmountedorFloorMount

Extended Arm Reach15"StraightArm-61"24"StraightArm-71"33"StraightArm-80"

HeightofunitwithArmsfolded(WallMount) 49"±0.5

HeightofunitwithArmsfolded(FloorMount) 77"±0.5

StraightArmRotationaboutBase 160°±10°

ScissorArmSwing(WallMount) 205°±5°

ScissorArmSwing(FloorMount) 90°±5°

Tube-head swivel on horizontal plane 530°±10°

Tube-head rotation about Vertical Plane 305°±5°


47

Table A4. Mains Power Requirements

Description Requirement

Linevoltagerange 110VAC±10%,

Rangeofline-voltageregulationforoperation at maximum line current

±1%maximumat99VAC,60Hz

Line frequency Nominal:60Hz Range:54Hzto66Hz

MomentaryCurrent(70kV,8mA) 8A@110VAC

MomentaryPower(70kV,8mA) 0.88kVA@110VAC

Standby Current 250mA maximum

Line resistance ≤0.4Ohm

Current Peak 30 A for 2 ms at mains turn on

InputPowerFactor >0.9duringanyexposure

ElectricalClassification ClassI,TypeB

Electrical Connection Line,NeutralandGround,1-Phase (GroundisMandatory)

Table A5. Environmental Conditions

Description Specification

Operatingconditions Temperature:50°Fto104°F

Humidity:25%to75%

Altitude:1500m

Conditionsfortransportandstorage Temperature:-22°Fto158°F

Humidity:95%noncondensing

Altitude:3500m


48

Annex B: Declaration of Conformity

B1: Name and Description of ProductMedicaldevicename:ImageWorksHighFrequencyIntraoralX-RayMedicaldevicemodel:ImageWorksHighFrequencyIntraoralX-RayDeviceVariants:303-000133-X:ImageWorksHighFrequencyIntraoralX-RaywithFocalSpotSize0.5inaWallMountconfigurationsusingaStraightArm.WhereX=15",24"and33".303-000133-8:ImageWorksHighFrequencyIntraoralX-RaywithFocalSpotSize0.5inaFloorMountconfiguration.MedicaldeviceType:DentalX-RaySystemMedicaldeviceclassification:IIb-Rule10-MDD,ClassIIFDA

B2: Standards under which conformity is declared:ANSI/AAMIES60601-1:2005+C1:09+A2:10IEC60601-1:2005+CORR.1:2006+CORR.2:2007CAN/CSA-C22.2No.60601-1:2008IEC60601-1-2:2006IEC60601-1-3:2008IEC60601-2-65:2012IEC60601-2-28:201021CFR,SubchapterJ,CMDR SOR/98-282

B3: Marking :TheproductsdescribedhereinconformtotheULsafetymarking.

B4: DeclarationTheproductsdescribedherein,aredesigned,manufactured, inspected, tested,and releasedbySkanrayTechnologiesPvtLtd,acontractmanufacturerforImageWorks,Inc.,inaccordancewithFDA's21CFR,Part820,ISO9001:2008(ULFile#A17728)andISO13485:2003(ULFile#A17728).

B5: Authorized Representative

ImageWorks250ClearbrookRoad,Suite240Elmsford,NY10523USA1-914.592.6100 - Voice1-800.592.6666-TollFree1-914.592.6148-FaxWeb:www.imageworkscorporation.com

49

Annex C: Guidance & Manufacturer's Declaration

Table C1. Guidance and Manufacturer’s Declaration – ElectromagneticEmissionsForallEQUIPMENTandSYSTEMS

Emissions Test Compliance Electromagnetic Environment - Guide

RFemissionsEN55011 Group 1ImageWorks High Frequency Intraoral X-Ray uses RFenergy only for its internal function. Therefore, its RFemissions are very low and are not likely to cause any interference in nearby electronic equipment.

RFemissionsEN55011 Class A

ImageWorksHighFrequencyIntraoralX-Rayissuitableforuseinallestablishments,otherthandomesticestab-lishments and those directly connected to the public low-voltagepowersupplynetworksupplyingbuildingsusedfor domestic purposes.

Harmonic emissions EN61000-3-2 Class A

Voltagefluctuations/flicker EN61000-3-3 Complies

Accordingto:EN60601-1-2:2001+A1:2006(Group 1, class A, for use in Hospitals) (Not LIFE-SUPPORTING)

ImageWorksHighFrequencyIntraoralX-RayistestedperapplicableIECstandards,tobeusedunderelectromagnetic environment specifiedbelow.The customeror theuser of ImageWorksHighFre-quency Intraoral X-Ray should assure that it is used in such an environment.

50


Table C2. Guidance and Manufacturer’s Declaration – ElectromagneticImmunityForallEQUIPMENTandSYSTEMS

Immunity Test EN 60601 Test Level Compliance Level Electromagnetic Environment - Guidance

Electrostatic dis-charge(ESD)EN61000-4-2

±(2,4,6)kVcontact±(2,4,8)kVair

±(2,4,6)kVcontact±(2,4,8)kVair

Floorsshouldbewood,concreteorceramic tile. If the floor is coveredwith synthetic material, the relativehumidityshouldbeatleast30%.

Electrical fast tran-sient/burstEN61000-4-4

±2kVforpowersup-ply lines±1kVforSignallines

±2kVforpowersupplylines±1kVforSignallines

Mains power quality should be that of a typical commercial or hospital envi-ronment.

SurgeEN61000-4-5±1kVDifferentialmode±2kVCommonmode

±1kVDifferentialmode±2kVCommonmode

Mains power quality should be that of a typical commercial or hospital envi-ronment.

Voltagedips,shortinterruptions & volt-agevariationsonpower supply input lines EN61000-4-11

<5%UT(>95%dipinUT) for0,5cycle

<5%UT(>95%dipinUT) for0,5cycle

Mains power quality should be that of a typical commercial or hospi-tal environment. If the user of the Imageworks High Frequency In-traoral X-Ray requires continued operationduringpowermains inter-ruptions,itisrecommendedthatthisHighFrequencyIntraoralX-Raybepowered from an uninterruptible power supply or a battery.

40%UT(60%dipinUT) for 5 cycles

40%UT(60%dipinUT) for 5 cycles

70%UT(30%dipinUT)for25cycles

70%UT(30%dipinUT)for 25 cycles

<5%UT(>95%dipinUT) for 5 sec

<5%UT(>95%dipinUT) for 5 sec

Power frequency (50/60Hz)magneticfieldEN61000-4-8

3 A/m 3 A/mPower frequency magnetic fieldsshould be at levels characteristic of a typical location in a typical com-mercial or hospital environment.

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TableC3.GuidanceandManufacturer’sDeclaration-ElectromagneticImmunity- forallEQUIPMENTandSYSTEMSthatarenotLIFE-SUPPORTING

Immunity Test EN 60601 Test Level Compliance Level Electromagnetic Environment – Guidance

ConductedRF EN61000-4-6

3 Vrms 50 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Portable/mobileRFcommunicationsequipmentshouldbeusednoclosertoanypartoftheImageworksHighFrequencyIntraoralX-Ray,includingcables,thantherecommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance

d=1,2√P

d=1,2√P80MHzto800MHz

d=2,3√P800MHzto2,5GHz

WherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer and d is the recommended separation distanceinmeters(m).

RadiatedRF EN61000-4-3

3 V/m 80MHzto2,5GHz

3 V/m 80MHzto2,5GHz

Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey,ashould be less than the compliance level in each frequencyrange.Interference may occur in the vicinity of equipment markedwiththefollowingsymbol:

At80MHzand800MHz,thehigherfrequencyrangeapplies.Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflec-tionfromstructures,objectsandpeople.

a Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.Toassess theelectromagneticenvironmentdue tofixedRF transmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichIntraskanDCisusedexceedstheapplicableRFcompliancelevelabove,theImageworksHighFrequencyIntraoralX-Rayshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybeneces-sary,suchasreorientingorrelocatingtheImageworksHighFrequencyIntraoralX-Ray.

b Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

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Annex D: Contact Details

Corporate Head Quarters/ Factory and Technical Support

ImageWorks250 Clearbrook Road, Suite 240Elmsford, NY 10523 USA1-914.592.6100 - Voice1-800.592.6666 - Toll Free1-914.592.6148 - FaxWeb:www.imageworkscorporation.com

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