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Medical Device

OFF Power IEC 60417-5008.

ON Power IEC 60417-5007.

On/Off Power IEC 60417-5010.

Consult electronic instructions for use (Standard ISO 7000-1641).

Operating temperature limits

Separate collection for electrical and electronic equipment according to

Directive 2012/19/EU (WEEE).

Serial number (Standard ISO 7000).

Standby IEC 60417-5010

Storage temperature limits

Type B applied part (Standard IEC 60417).

UL Laboratory Equipment Listing

3 Symbols on product labels

6 KaVo ProXam iOS

Instructions for use

Содержание ProXam iOS

Страница 1: ...KaVo ProXam iOS Instructions for use EN...

Страница 2: ...to the appropriate requirements such as IEC 60364 equipment is used according to the operating instructions Planmeca pursues a policy of continual product development Although every effort is made to...

Страница 3: ...11 5 2 2 DICOM storage optional 12 5 2 3 Viewing and opening cases in Romexis 3D module 12 5 2 4 Combining model to 3D volume 12 6 Scanner setup 13 6 1 Connecting scanner cable 13 6 2 Plugging scanne...

Страница 4: ...odel 38 9 15 Eraser tool 38 9 16 Triming model 40 9 17 Colour model or stone model 41 9 18 Checking model for missing data 41 9 19 Delete model 42 9 20 Scanning upper and lowel 43 9 21 Editing scan la...

Страница 5: ...iting models in object browser 85 11 6 Analyses 86 11 7 Comparison tools 86 11 7 1 Side by side comparison 86 11 7 2 Superimposition 87 11 7 3 Sync camera 88 11 7 4 Fit surface models 88 11 8 3D print...

Страница 6: ...8 15 1 KaVo ProXam iOS specification 108 15 1 1 Applicable standards 109 15 1 2 Approvals all systems 110 15 1 3 Optical specifications 110 15 1 4 External components and connectors 111 15 1 5 UL list...

Страница 7: ...and or full arch and preparation areas including features such as implant scan locator fixtures braces brackets etc In addition it can record the topographical characteristics of the oral anatomy suc...

Страница 8: ...Inteded use environment The optical impression system is intended to be used in indoor environments only such as dental offices dental laboratories and dental schools 1 1 6 Side effects No side effect...

Страница 9: ...2 Associated documentation Romexis 6 user s manual 2 Associated documentation Instructions for use KaVo ProXam iOS 3...

Страница 10: ...issing or illegible please contact the manufacturer for replacement labels NOTE The labels may have changed since this manual was published NOTE Label examples are not shown in their actual size Alter...

Страница 11: ...warning Standard ISO 7010 Humidity limitation Keep away from rain Laser information Laser warning Lot number Manufacturer Standard ISO 7000 Laser class 1 Standard IEC 60825 Class 1 laser product Stan...

Страница 12: ...641 Operating temperature limits Separate collection for electrical and electronic equipment according to Directive 2012 19 EU WEEE Serial number Standard ISO 7000 Standby IEC 60417 5010 Storage tempe...

Страница 13: ...cause radio interference in which case the user may be required to take adequate measures WARNING When connecting the components use only the cables supplied with the scanner Failure to do so may resu...

Страница 14: ...ignment do not drop or strike the scanner Follow all stated precautions when using the scanner WARNING To prevent electrical shock and eye damage by laser radiation do not open any sealed covers or co...

Страница 15: ...section Cleaning preventive maintenance on page 101 CAUTION Do not stack the tips near or on any other metal instruments CAUTION Ensure your scanner is properly maintained see section Cleaning preven...

Страница 16: ...orks Open unlocked networks can make your system vulnerable 4 2 1 System default settings no user action required The following items are setup to protect your system by default and should not be disa...

Страница 17: ...is icon on your desktop or on the Windows menu The following message may appear from Windows Do you want to allow the following program to make changes to this computer 4 Click Yes This is a normal sa...

Страница 18: ...cases in Romexis 3D module All scans and designed restorations will automatically appear in the 3D module volumes list To view and open scans and cases in Romexis see section Viewing CAD CAM case in 3...

Страница 19: ...lowing components KaVo ProXam iOS scanner Scanner tip x 3 standard x 2 SlimLine x 1 Scanner cable x 2 Standalone holder Colour balancer Cover boot x 4 6 1 Connecting scanner cable Steps 1 Align the no...

Страница 20: ...r support or when replacing the cable 6 2 Plugging scanner into laptop About this task NOTE Keep the scanner connected to the cable at all times Remove the cable from the scanner only when directed by...

Страница 21: ...in use disconnect the cable from the laptop by grabbing on the connector CAUTION Do not pull on the cable itself to disconnect Bending or twisting the cable may impact system usability You do not nee...

Страница 22: ...he tip and the S displays on screen when in use The SlimLine tip is 5 7 mm thinner than the standard scanner tip With the SlimLine tip the field of view is 30 smaller compared to the standard tip 6 Sc...

Страница 23: ...s when the tip is removed The scanner comes with a removable tip When the scanner is not in use place the non functional protective scanner tip on the scanner delivered with the scanner To detach the...

Страница 24: ...cted while the next tip is being used For cleaning instructions see section Tip infection control procedure on page 101 6 4 Scanner holder The scanner comes with a standalone holder 6 Scanner setup 18...

Страница 25: ...plug the scanner cable while scanning NOTE Do not use the scanner when the battery is low If the computer has to shut down before the model is generated you will lose your scans Make sure the laptop i...

Страница 26: ...nual for information about adding and editing patient files 8 1 1 Starting new CAD CAM case About this task To begin scanning Steps 1 Do one of the following Add a new patient Click on a patient to hi...

Страница 27: ...e mouse horizontally vertically or diagonally to rotate the image Drag in small increments for more control 3 To stop rotating release the mouse button Repeat as needed 8 2 2 Changing model size About...

Страница 28: ...hout being rotated Follow these steps to move model Steps 1 Position the pointer on the model 2 Press and hold down the mouse wheel 3 Drag the model to the desired location and release the mouse wheel...

Страница 29: ...ng Apply To Default or Restore Factory Defaults will not affect individual cases that were customised 8 3 2 General Click Restore Factory Defaults to revert the current tab to original settings Click...

Страница 30: ...p s volume control To change the scanning music go to C Program Files PlanCAD bin Windows_App PlanCAD_Data StreamingAssets CustomMusic and save your file there The software should be able to read wav...

Страница 31: ...8 3 6 About settings Displays information about the software and the end user license agreement 8 Romexis CAD CAM module overview Instructions for use KaVo ProXam iOS 25...

Страница 32: ...power cord is being used on the laptop while scanning Scan tab layout 1 Workflow Wizard By default the Workflow Wizard is hidden Click the Wizard button to reveal hide the Workflow Wizard window Use...

Страница 33: ...canner graphic shows the Tip Information 9 3 Scanner icons 9 3 1 Sun icon See Model scanning on page 32 for detals 9 3 2 Imaging mode Activate Imaging Mode to use the scanner as an intraoral camera wi...

Страница 34: ...l to optimise the color This icon is available only when a Standard tip is connected 2 Insert the scanner with sterilised Standard size tip into the device as shown 3 Click Next Results Another screen...

Страница 35: ...e the top and bottom buttons simultaneously to Delete model Generate model Select colour stone view Select data density Steps 1 Press both buttons simultaneously while on the Layers tab A menu appears...

Страница 36: ...his can be turned OFF in Settings See Scan settings on page 24 for more information You do not have to follow the suggested pattern Click Close on the animation or start scanning to close the animatio...

Страница 37: ...oose a Workflow cannot be edited after scanning has started Restorative Upper Prep Lower Prep Buccal Bite Upper or Lower Preop Upper or Lower Preop Upper Prep Lower Prep Buccal Bite Upper or Lower Sca...

Страница 38: ...nother The system attempts to align it automatically If automatic alignment is unsuccessful a manual alignment window appears See Manual alignment on page 49 for more information Another option is to...

Страница 39: ...dback The Scanning Indicator box shows the current focus area and the outline colour changes according to the scanning status The colour changes from green scanning to red not scanning When the Scanni...

Страница 40: ...s and click Apply to Default 9 10 2 Checking scanning distance The distance between the scanner and the surface being scanned is indicated with a coloured box on the building model The colour of the o...

Страница 41: ...the reading range Red end of the reading range far away from tip NOTE Any colour shown means the scanner is capturing data The colours only correspond to the focal distance 9 10 3 Session usage A ses...

Страница 42: ...s a png image This allows you to easily share photos with your dental team or use them as a patient education tool The photos are available under Patient Data in the File module and under Photo in the...

Страница 43: ...t the blue laser into the distal interproximal area Scanner can be turned to a 90 degree angle if the position in the mouth allows it 3 Fill in missing data where needed 9 13 View controls Right click...

Страница 44: ...eneration option each model will generate as you switch layers click the Generate Model button or press M on the keyboard The system will process any ungenerated models when you exit the Scan screen e...

Страница 45: ...e Eraser icon with slider Click the Eraser tool to deactivate it TIP It is recommended that you not delete multiple teeth in a row Large gaps in the model is not recommended 9 Scanning Instructions fo...

Страница 46: ...ou may have difficulty with aligning your models Ensure you have your model at an even angle before trimming If you trim while the model is angled sharply you could accidentally trim away good data on...

Страница 47: ...lour like a poured stone model Use the sliders to adjust brightness and contrast if desired Color Model View Stone Model Upper Stone Model Upper beige Lower green Buccal blue Stone Model Pre op 9 18 C...

Страница 48: ...h should have good data on the interproximal contact area occlusal surfaces and of the lingual and buccal contours Data below the height of contour is not as crucial on the adjacent teeth Colour model...

Страница 49: ...A scan layer can be edited to change the name and or scan type This can be helpful if you accidentally scan something under the wrong label Steps 1 Right click the layer you want to edit 2 Click Rena...

Страница 50: ...te is scanned to align the upper and lower models While scanning the buccal the system attempts to automatically align the models and the Upper and Lower model will automatically appear in the model b...

Страница 51: ...ars with a notification noise then go to the opposing arch and repeat 3 b Scan the sides of the teeth that were captured in the upper and lower models Ensure some gingival data is captured First arch...

Страница 52: ...nning is stopped interim models appear in alignment NOTE If the models do not automatically appear for each arch scan the desired teeth and then manually align them See Manual alignment on page 49 for...

Страница 53: ...Bite 2 Refine 3 Verify alignment 4 If needed scan second Buccal Bite and refine 9 24 Occlusal contact strength About this task The Occlusal Contact heat map can be used to evaluate the alignment and...

Страница 54: ...cause any associated groups to be deleted 9 25 1 Create new alignment group About this task To create a new alignment group Steps 1 Drag one scan layer onto another If the system cannot align them au...

Страница 55: ...ired group Results The software attempts to align the new model to the group If it is unsuccessful for example if the upper arch aligned during the scanning of the buccal bite and lower arch did not y...

Страница 56: ...valuate the alignment If the previewed alignment will fail the Apply button is greyed out 7 You can click and drag to move adjust the points to improve the alignment or click Reset to start over 8 Cli...

Страница 57: ...as the preparation model 3 Scan the opposing and buccal bite 4 Insert the scan body and scan it under the Scan Body scan layer 5 Start the scanning at the gingival in order to capture enough data Whe...

Страница 58: ...gin Remove the excess impression material so that the scanner can get closer for scanning NOTE Any impression material can be used The system does not require a particular color or type of material Ab...

Страница 59: ...NOTE From the occlusal view the impression can give the optical illusion of looking like a regular model 4 Rotate the model to see all of the impression Be sure to check the contact areas on the adja...

Страница 60: ...one Mode 9 30 Full arch scanning About this task Follow these steps to perform full arch scanning Steps 1 Start on the distal of one side and scan the occlusal of the entire arch On the anteriors rota...

Страница 61: ...llow the instructions below to use the Open Bite workflow Steps 1 Select Open Bite as the workflow 2 Scan the Upper and Lower arches following the normal procedure 3 Have the patient bite on the bite...

Страница 62: ...are of one model 9 33 Import model About this task Follow these instructions to import a model Steps 1 Click a scan layer to select it 2 Right click the scan layer and select Import Model 3 Navigate t...

Страница 63: ...add scans or use the Erase tool on imported models 8 Repeat for all of the desired layers 9 34 Export model About this task Follow these instructions to export a model Steps 1 Click on a scan layer t...

Страница 64: ...tool groups on the Margin tab Draw Margin Add Segment 10 1 Draw margin About this task Follow these instructions to use the Draw Margin tool Steps 1 Click the Draw Margin tool The Tooth Indicator scr...

Страница 65: ...see margin or clicking in large increments may cause the system to lose track of the margin edge This can be corrected after the margin is drawn 7 Click the starting point to finish the margin The sy...

Страница 66: ...uating the margin 10 2 1 Color model view NOTE Color model view is for intraoral cases only Use Color Model to toggle between color view and stone view This can aid in seeing the margin in some cases...

Страница 67: ...slice 1 rotated to view other side Full arch slice 1 Follow these instructions to use the Slice Plane tool Steps 1 Rotate the model to view the slice from the other side 10 Margin tab Instructions fo...

Страница 68: ...Click Show Hide Margin to toggle the margin on off 10 2 4 Model opacity Use the slider to change the opacity of a model 10 3 Path of insertion About this task Path of Insertion is automatically activ...

Страница 69: ...a variety of ways to edit the margin These can be done in any order Click and drag a control point to move it Right click on a control point and select Delete Control Point to remove a single dot Dele...

Страница 70: ...10 Margin tab 64 KaVo ProXam iOS Instructions for use...

Страница 71: ...opened from the case list it appears in the Analyse tab 11 1 Preparation tools 11 2 Defining occlusion plane To orientate model the occlusal plane and midline must be defined 11 Analyse tab Instructi...

Страница 72: ...3 point alignment About this task Follow these instructions to define 3 point alignment Steps 1 Indicate 3 points right molar midline and left molar from the surface of the model by clicking on the m...

Страница 73: ...atically aligned 2 If necessary fine tune the alignment manually see section Manual alignment on page 68 3 Finish the alignment and exit the dialog by clicking Done 11 Analyse tab Instructions for use...

Страница 74: ...anual alignment If necessary you can use manual alignment to fine tune alignment after 3 point alignment You can freely translate the models by dragging 11 Analyse tab 68 KaVo ProXam iOS Instructions...

Страница 75: ...models drag from the arcs around the models To change viewing direction use the buttons on the manual alignment toolbar 11 3 Trimming model Paint ROI to trim 11 Analyse tab Instructions for use KaVo...

Страница 76: ...t keys while scrolling the mouse wheel To increase the size of the trimming tool zoom out To rotate models while trimming hold down the Alt key while dragging The surfaces behind the painted area s ar...

Страница 77: ...orientation to the state right after model orientation Multi view To visualise models from different directions and occlusal view at the same time click multiple views 11 4 1 Calculate contact map Ca...

Страница 78: ...set the maximum distance visualised drag the blue dot Model overlap is visualised in grey 11 4 2 Calculate undercuts About this task Follow these instructions to calculate undercuts Steps 1 Select the...

Страница 79: ...coloured in blue To change the insertion direction deactivate the tool re orient the model and click the button again The colour of the surface model returns to normal when the tool is deactivated 11...

Страница 80: ...ot is saved to 2D imaging module under Photos 11 5 Measurement tools 11 5 1 Point to point measurement About this task Use this tool to measure a distance from one point to another Steps 1 Activate th...

Страница 81: ...1 Click the Tooth width measurement tool 2 Click a numbered tooth on the chart In the upper jaw start from the posterior right side in the lower jaw start from the posterior left side 3 Click the dis...

Страница 82: ...measurement About this task Arch length measurement is calculated as a projection of the 3D points on the occlusal plane This measurement is used in some of the analyses NOTE The first arch length mea...

Страница 83: ...Steps 1 Activate the Arch length measurement tool The open bite view opens by default 11 Analyse tab Instructions for use KaVo ProXam iOS 77...

Страница 84: ...the view hold down the Alt key while dragging the model 3 When enough measurement points have been added complete the arch by deselecting the measurement tool or right click on the model Results The...

Страница 85: ...urement About this task The LM Activator arch length measurement tool aids in the selection of the appropriate appliance model and size The tool measures the distance across the incisors from the mesi...

Страница 86: ...eth are not guided towards the bottom of the slots but constrained by the ridges between the slots treatment may not be successful It is particularly important to check that the LM Activator applies d...

Страница 87: ...se wheel To adjust the view hold down the Alt key while dragging the model 3 Measure the arch length from the mesial surface of 13 to mesial surface of 23 by clicking on the vestibular surface of the...

Страница 88: ...process for lower teeth Results The measurements appear in the object browser 11 5 6 Drawing tooth margin About this task Margin line can be used for drawing an outline for prepared teeth before sendi...

Страница 89: ...ch you want to draw a margin 3 Click around the tooth to add points for a margin line At minimum three points are required A margin line is automatically drawn between the added margin points 11 Analy...

Страница 90: ...margin is red To change the colour click the red square next to the margin in the object browser and select the desired colour from the colour map To change the camera viewing angle hold down the Alt...

Страница 91: ...models in object browser In the object browser you can Show hide models by clicking this button Adjust transparency using the sliders Change model colour by clicking the square next to the model and...

Страница 92: ...ysis use the following formulae Measure arch circumference from mesial of first molar to mesial of first molar space available Measure the mesiodistal width of teeth from 5 to 5 and add together space...

Страница 93: ...on click on the desired notch What to do next You can adjust the colour and opacity of a model by selecting it in the object browser and dragging the slider To hide models from view click the Show Hid...

Страница 94: ...rotated the left side rotates accordingly and vice versa When the sync button is not selected both views can be adjusted independently 11 7 4 Fit surface models About this task Follow these instructio...

Страница 95: ...able models Before you begin NOTE Check the trimming to make sure no extra data is left outside the model About this task Follow these instructions to create 3D printable models Steps 1 Click the Gene...

Страница 96: ...3D models with bases About this task The folder where the models are exported must be defined in the Admin module for more information see the Romexis technical manual Steps 1 Click the Export the se...

Страница 97: ...be opened in Analyse tab Currently open case is indicated in the case list with blue background Inactivating cases Select the case folder and click Inactivate from the right click menu To inactivate a...

Страница 98: ...lyse tab 12 2 2 Filling in lab order form About this task Follow these instructions to create an order form in PDF format Steps 1 Select the case in Case list 2 Click Create Lab Order under File 3 Fil...

Страница 99: ...o select the whole upper or lower jaw select the correct jaw icon in the centre of the chart Implant guide Aligner Denture and 3D printed model are only available for full arch 5 Click Character 12 Se...

Страница 100: ...tion 9 When finished with adding restorations click Ready The restoration appears at the bottom of the window Results Once a lab order has been created it can be inactivated viewed as PDF or edited by...

Страница 101: ...orm can also be accessed in the File module under Attachments from where it can be opened by double clicking 12 2 3 Adding abutments to lab order form About this task To define an underlying implant S...

Страница 102: ...idge in the Tooth selection field 3 Select Bridge as indication 4 Create the bridge structure by clicking on the grey dots The clicked dots turn green marking the location of the bridge 12 2 5 Sending...

Страница 103: ...tion under Export NOTE CAD CAM export to 3Shape Dental System 2015 in 3oxz format is compatible with 3Shape Dental System 2015 software revision 15 5 0 3 Select the folder where to export the models W...

Страница 104: ...nual 12 4 2 DDX Cloud About this task Use Digital Dental Exchange to send cases digitally Steps 1 Select the cases to export in Case list 2 Click DDX Cloud under Send For more information see Romexis...

Страница 105: ...echnical manual Follow these instructions to send models Steps 1 Select the case to export in Case list 2 Click SimToCare under Send 3 Enter a valid email address a message and if desired a due date T...

Страница 106: ...e code if needed NOTE The code is not saved anywhere Once the QR code dialog is closed you cannot retrieve the code from Romexis In addition to the QR code a password is requested If necessary you can...

Страница 107: ...ed Cleaning the scanner tip incorrectly may result in incomplete disinfection and or permanent damage to the tip WARNING It is of utmost importance to clean the scanner tip after every patient to ensu...

Страница 108: ...ld be able to produce a low rate of between 4 8 Lpm 6 Rinse and brush around the edge and surrounding crevices of the mirror under running water for a minimum of 30 seconds NOTE To avoid scratching th...

Страница 109: ...on time is 10 minutes For any autoclave use a minimum dry time of 30 minutes 12 Whe the cycle has completed store the tip for later use 13 1 2 Storage About this task Follow these instructions to stor...

Страница 110: ...nge that has been saturated with a hospital grade TB rated germicide or pre moistened germicidal wipes apply the germicide to the entire surface of the scanner base scanner holder mouse mouse pad and...

Страница 111: ...moved once a month for cleaning Follow these instructions when cleaning the rubber sleeve Steps 1 Start on the bottom of the sleeve and flip roll it upwards 2 Continue rolling to the top of the scanne...

Страница 112: ...structed in section Cleaning scanner base and other surfaces after every patient on page 104 above 4 Ensure the cover is right side out and slide it back onto the scanner 13 Cleaning preventive mainte...

Страница 113: ...rvice KaVo Technical Service If you have any questions or complaints please contact the KaVo Technical Service 49 0 7351 56 2900 service cadcam kavo com 14 Service Instructions for use KaVo ProXam iOS...

Страница 114: ...ting conditions 15 C to 28 C 59 F to 82 F 5 95 non condensing relative humidity Maximum altitude 2 000 m 6 562 ft Dimensions Scanner with tip 41 x 45 x 249 mm 1 6 x 1 8 x 9 8 in Scanner without tip 40...

Страница 115: ...compatibility ISO 10993 European standards 93 42 EEC Medical Device Directive EN 60601 1 2006 Safety of Medical Electrical equipment EN 60601 1 2 Electromagnetic Compatibility EN 60825 1 Safety of La...

Страница 116: ...pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment g...

Страница 117: ...reasonable fault conditions 15 1 4 External components and connectors When connecting external components to the system attach only devices that have an appropriate NRTL mark for compliance with IEC...

Страница 118: ...r emissions IEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity The scanner is intended for use in the electromagnetic environment specified below The custome...

Страница 119: ...wered from an uninterruptible power supply UPS or a battery Power frequency 50 60Hz Magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a t...

Страница 120: ...s may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base station...

Страница 121: ...the maximum output power of the communications equipment Rated maximum output power W of transmitter Separation distance m according to frequency of transmitter 150 kHz to 80 MHz d 1 2 P 80 MHz to 800...

Страница 122: ...trouble scanning Scan Bodies I m having trouble saving cases I m having trouble saving cases How do I change the tooth number or preparation type on an existing margin How do I change the tooth number...

Страница 123: ...ot affect the stone model nor the amount of data collected by the scanner See Colour balancing on page 28 for more information My scanner seems to have slowed down Is your laptop plugged in Ensure the...

Страница 124: ...e if it connects okay A strange spider web chicken wire graphic appears when I try to scan This occurs if the scanner has not initialized correctly Unplug the scanner and plug back in I m having troub...

Страница 125: ...turer that any computers connected to a Romexis Server be hard wired This will ensure reliability faster saving and a more robust infrastructure If wireless networks are used it can lead to data loss...

Страница 126: ...date warning Dialog box appears if a windows update is being installed in the background Scanning is not recommended during Windows updates Low disk space warning Dialog box appears if the amount of a...

Страница 127: ...and Print Screen or Prt Scr keys The computer takes a screen shot and saves it in the folder Libraries Pictures Screenshots The screen shots are automatically numbered You can rename them if desired...

Страница 128: ...l waste legislation and instructions issued by the environmental authorities The risks involved and the necessary precautions must be taken into account when handling waste products Batteries must be...

Страница 129: ......

Страница 130: ...KaVo Dental GmbH Bismarckring 39 88400 Biberach Deutschland www kavo com 1 015 1250...

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