English - coDiagnostiX
Contents
1. Planning is performed by the calculation of several views such as vir tual OPG or a three dimensional reconstruction of the image data set by the analysis of the image data and the placement of im plants abutments and drilling sleeves INTRODUCTION AND OVERVIEW 2 2 1 Device variants and configuration coDiagnostiX is available in a producer and a client version The client can export digital drill guide and virtual planning data only through a coDiagnostiX M producer version coDiagnostiX Is an open software system The library contains im plant abutment and sleeve systems from a large number of manu facturers For drill guide fabrication with the gonyX M a template plan from coDiagnostiX M is required 2 2 2 Principles of operation Implant planning with coDiagnostiX M is part of an overall guided sur gery workflow There are two principal workflows that can be real ized with coDiagnosti X M e Analog workflow using gonyX and its accessories s Digital workflow using 3D manufacturing systems INTRODUCTION AND OVERVIEW 2 2 2 1 Guided surgery workflow The following chart outlines the positioning of coDiagnostiX within the general guided surgery work flow 12 DIGITAL Master model Scan Scan template fabrication CBICT scan Without scan template coDiagnostix 3D implant planning Drill guide fabrication 3D manufacturing Guided surgery ANAL2. coDiagnostiX 9 INSTRUCTIONS FOR USE S dental wings Important Keep this document for future reference CONTENTS 1 1 UR A L Laa 24 23 Zo 2 2 8 La 2 10 2 11 om SZ S 3 4 4 1 4 2 4 3 4 4 4 9 4 6 4 1 ABOUT THIS GUIDE Disclaimer License trademarks and copyright INTRODUCTION AND OVERVIEW Intended use Device description and features 2 2 1 Device variants and configuration 2 2 2 Principles of operation 2 2 3 Accessories and products used in combination Indications Contraindications Safety Precautions Compatibility information Data protection Further information Installation Disposal USER INTERFACE AND coDiagnostix BASICS Toolbar Views Object tree Plans STEP BY STEP CASE PLANNING Import DICOM data Define panoramic curve Import and match model scan data Detect nerve canal Detect gonyX reference pins Plan implant Plan abutments coDiagnostiX 9 INSTRUCTIONS FOR USE 10 10 10 11 11 14 21 21 21 22 29 29 26 26 2 29 29 30 OZ ES 34 ES 36 37 3 40 42 43 Dental Wings GmbH 4 8 Han sleeves 4 9 _ Design digital drill guide 4 10 Print protocols 4 11 coPeriodontiX 9 SAFETY CHECK 6 DISTRIBUTORS AND SERVICE 7 SYMBOLS ON THE PRODUCT AND OR PACKAGING Dental Wings GmbH 44 45 48 49 52 oo 06 coDiagnostiX 9 INSTRUCTIONS FOR USE 1 ABOUT THIS GUIDE These Instructions for Use are
3. Thoroughly check the congruency of the contours of the merged 3D objects in all views to ensure correct and accurate alignment of both objects upon import Matching of model scan data Is a prerequisite for digital drill guide design Match ing accuracy directly influences the accuracy of the digitally designed drill guide A Caution Inadequate drill guides may result In damage to vital anatomy at the time of surgical implant placement STEP BY STEP CASE PLANNING 45 Design wizard Select Object gt Add gt Digital Drill Guide from the main menu to open the wizard Decide If you want to create a completely new digital drill guide or use an existing guide as template Define the insertion direction for the drill guide Specify contact surfaces and sleeve mount dia meter and height Set offset and wall thickness e Add inspection windows and labeling text both optional Finish your guide Export your drill guide producer version only For further information see the coDiagnostix Help General prerequisite for accurate implant place ment results is the compliance by the user with all Instructions given by the software manufac turer as well as an accurate planning with coDiagnostiX on the part of the user After prior implant planning with coDiagnostix the accuracy of the drill guides and the location of the surgical site depend on the following factors a The quality of the CB CT
4. CAMLOG Biotechnologies AG Switzerland Steco is a registered trademark of steco system technik GmbH amp Co KG Germany bredent is a registered trademark of Bredent Dentalgerate und Ma terialien Fach und Organisationsberatung Peter Brehm Germany Neoss is a registered trademark of Neoss Limited United King dom 3Dconnexion is a registered trademark of 3Dconnexion GmbH Germany Copyright Dental Wings documents may not be reprinted or published in whole or in part without the written authorization of Dental Wings ABOUT THIS GUIDE 9 2 INTRODUCTION AND OVERVIEW 2 1 Intended use coDiagnostiX is intended to be used as preoperative planning soft ware for dental implant placement 2 2 Device description and features coDiagnostiX M is a 3D Implant planning software allowing the import and processing of the 3D CB CT scan dataset DICOM standard Based on the finalized implant planning the software allows for ex port of data for the production of drill guides using 3D manufacturing systems or the analog gonyX table In the analog workflow the pa tient has to wear a scan template with reference pins during the CB CT scan Working with the software Is based on a patients medical image data such as a CT Computed Tomography and CBCT Cone Beam Computed Tomography that is processed by coDiagnostiX after be ing transferred via CD DVD network or various other storage medi ums
5. To add further icons drag and drop the icon from the box onto the toolbar o remove icons from the toolbar simply drag them off the toolbar USER INTERFACE AND coDiagnostiX BASICS To add a new symbol drag it into the toolbar To remove a symbol drag and drop it from the toolbar back to the symbol list ep Separator Close Open gonyx Print all registration Reference lines 2D Reference planes Orientation Millimeter scales Zoom 3D indicators T 8 Reset views Move and turn Localizer AddTooth Delete position E x WB A Properties Positioning mode Density Redo Unda measurement e a2 p Vertical 3D cut Horizontal 3D cut Brightness Implant Designer Hide sidebar Analog workflow y Analog workflow Digital workflow 29 3 2 Views ER Views are color coded and can be displayed in other views as reference line with the re spective color Enlarge a view by clicking the Full Screen button or double click the title bar Move the Panoramic view inside and outside with the right scroll bar Moving views Enable the Move and Turn tool Move the view with the left mouse button Rotate the view with the right mouse button 3D view only 30 USER INTERFACE AND coDiagnostiX BASICS Manipulating the views most important tools Enables disables the Move and Turn tool Enables disables the Localizer tool Enables disables the Zoom tool Resets al
6. firewall Use a strong password to protect your computer system storage media and presentation devices Use data encryption to secure data on your computer system and storage media Backup your data regularly Use the anonymization function to protect patient personal data If required Archiving and restoring datasets in different versions of coDiag nostiX can cause compatibility problems 24 INTRODUCTION AND OVERVIEW 2 Compatibility information Caution Archiving and restoring datasets in different versions of coDiag nostiX M can cause compatibility problems Avoid using different versions of coDiagnostiX If you have any prob lems contact customer service In general patient datasets from older versions of coDiagnostiX can be opened with coDiagnostix 9 0 and above backward compatibility Check your dataset carefully to avoid minor incompatibilittes which might lead to failures in the planning of dental implants and or the production of scan templates or drill guides Older versions of coDiagnostiX however cannot work with datasets from coDiagnostiX 9 0 and above no forward compatibility of older coDiagnostiX versions 2 8 Data protection Access to the software Is restricted by the licensing system To protect data against loss or unauthorized use several security mechanisms have been implemented In coDiagnostiX Data encryption during storage and transfer throu
7. influences the accuracy of the digitally designed drill guide A Caution Inadequate drill guides may result In damage to vital anatomy at the time of surgical Implant placement f the result is not satisfying align the model scan manually in all 4 views To do so move the scan contours with the mouse or use the Fine Alignment function a Click the Finish button to apply the scan im port to your case For more detailed information consult the coDiagnostiX Help 38 STEP BY STEP CASE PLANNING 4 4 Detect nerve canal s Click the Nerve Canal icon to add the nerve canal objects The positioning mode will be ac tivated automatically In the object tree select the nerve canal you want to detect Set the entry point foramen mentale and the exit point foramen mandibule directly in the views Each nerve canal point can be moved and addi tional points can be added In all views To sup port nerve canal detection you can set as many nerve canal points as you want and In any view you like s Click Detect in the object tree coDiagnostix will automatically detect the nerve canal A Caution Always verify the correctness and accuracy of nerve canal display Automatic nerve detection does not guarantee exact and accurate nerve canal display Make sure to always verify the correct position of the nerve canal manually If nerve definition is not clear due to poor image guality the dataset must not b
8. intactness and operational readiness of hardware ele ments dongle data carriers and other material provided for instal lation and use of coDiagnostiX comply with the following condi tions Operating temperature 10 C to 40 C s Relative humidity 20 to 80 Storage temperature 20 C to 40 C 20 INTRODUCTION AND OVERVIEW 2 3 Indications coDiagnostiX is an implant planning software tool intended for use by dental professionals who have appropriate Knowledge in implanto logy and surgical dentistry This software reads Imaging information output from medical scan ners such as CB CT scanners It allows preoperative simulation and evaluation of patient anatomy and dental implant placement For automated manufacturing of drill guides in the dental laboratory environment coDiagnostiX M allows for export of data to 3D manu facturing systems Alternatively coDlagnostiX provides printouts of template plans for the creation of drill guides using a manually oper ated gonyX table 2 4 Contraindications coDiagnostiX is not intended to be used in direct contact with the patient nor Is it intended to be used with life sustaining devices coDiagnostiX must only be applied If additional radiation dose from 3D radiology compared to conventional x ray can be justified Con traindications applying to other medical devices used within the scope of a guided surgery workflow have to be taken into consider
9. when an element is placed such that the distance to other elements Is less than a defined value The user may still place the element where de sired to facilitate the surgical planning process Final element placement must be consistent with patient anatomy and the judgment of the clinician ae Distance to other sleeves SAFETY CHECK Distance Distance check check Adjustable by user Default 3 mm 2 mm value A Caution Always maintain an appropriate safety distance to the nerve canal Always maintain an appropriate distance around the implant v Always verify automatic nerve canal detection manually v If the analog workflow is used always ensure correct fit of scan template during radiology v Always give the information concerning CB CT scans accessible via the Help menu in the software to the radiologist before the first scan v Control all automatic functions of the soft ware v After planning is completed always finalize the plan Plan gt Finalize to ensure that the plan cannot be modified later SAFETY CHECK coDiagnostix Version 9 2 Licensed to 80030309 Dental Wings GmbH Patient data Name Patient 6 Date of birth 19591231 Patient ID 00143103 Mandible J3 v Check all printouts template plan gonyX verification etc to ensure that they belong to the corresponding finalized plan v Backup your data at regular intervals to avoid loss of data due to system
10. NG 4 1 Import DICOM data a Click Create dataset DICOM on the start screen Select Import data from CD DVD and click Im port a In case of any problems error messages warnings etc contact customer service Choose If you would like to plan a case for maxilla or mandible To plan both maxilla and mandible you need to create two separate plans coDiagnostiX switches to the standard planning screen AX Caution Do not use datasets which can be created in Spite of warning messages unless you fully un derstand the consequences of those warnings and are sure that there will be no unacceptable risk for the correctness and accuracy of your planning STEP BY STEP CASE PLANNING Quick D DICOM Trancfer Quick DIC COM Transfe Recently opened datasets Open dataset Demo Patient 5 CT Create dataset DICOM Quick DICOM Transfer Transfer DICOM images to database D Import data from CD DVD Import data from selected source CAUsersi z Switch to advanced mode on 4 2 Define panoramic curve a Click the Panoramic Curve icon Grab the points with the left mouse button and move the curve according to the patient s ana tomy O create additional points click outside the existing five basic points o delete additional points right click on the point and select Delete Point from the context menu The five basic points cannot be deleted 36 Hm o Press an
11. OG Fabrication With scan template VK With gonyx coDiagnoslix INTRODUCTION AND OVERVIEW 2 2 2 2 coDiagnostiX M workflow This chart outlines the standard work steps within coDiagnosti X M STEP BY STEP CASE PLANNING DIGITAL INTRODUCTION AND OVERVIEW Import DICOM data amp create dataset Define panoramic curve import model scan Detect nerve canal Register gonyxX coordinates Plan implants Plan sleeves Design amp export drill quide Print planning ar EENEG SP D Tab r mm WY kenge cm PT MU tee gt l Hr gil me i hn i FB Ed kp e Aren ms oo For further details see chapter 2 2 3 Accessories and products used in combination Analog workflow using gonyX and its accessories The use of the following products and accessories in combination with coDiagnostiX M has been validated gonyX M Device for scan template and drill guide fabrication by the dental laboratory gonyX accessories include Straumann reference pin and templix reference plate Devices for scan template production Straumann scan control bar Additional device for enhancement of quality of CT scans Straumann generic sleeve positioner including closing lid Device for sleeve positioning with gonyX Other products may in principle be suitable as well However the user has to validate their compatibility with coDiagnost
12. a tion 2 9 Safety There is no physical chemical electrical mechanical biological or electromagnetic hazard related to the software INTRODUCTION AND OVERVIEW ral Nevertheless the software has several integrated warning functions designed to alert and remind the user of his her legal responsibility to plan precisely and verify all planning results 2 6 Precautions Please be aware that the user of coDiagnostiX software Is solely responsible for the correctness accuracy and completeness of all data entered Into the coDiagnostiX software Do not use datasets which can be created In spite of warning mes sages unless you fully understand the consequences of those warn ings and are sure that there will be no unacceptable risk for the cor rectness and accuracy of your planning Automatic nerve detection does not guarantee exact and accurate nerve canal display Make sure to always verify the correct position of the nerve canal manually Always verify the correctness and accuracy of nerve canal display If nerve definition is not clear due to poor image quality the dataset must not be used Always maintain an appropriate safety distance to the nerve canal Datasets with reference pins in both jaws maxilla and mandible The automatic pin detection of coDiagnostiX EASY cannot distin guish between pins in the maxilla and those in the mandible when scanned together This can result in inaccurate planning A
13. anatomy at the time of surgical implant placement INTRODUCTION AND OVERVIEW 23 coDiagnostiX is not intended to be used in close proximity within a distance of 1 5 meters from the patient Make sure to comply with all applicable standards and technical regulations for any computer hardware used together with coDiagnostiX M For example Do not use multiple socket extension cords Do not touch the patient and simultaneously plugs ports or other connecting parts of the hardware Make sure that computer hardware which is used together with coDiagnostiX M is at least 1 9 meters away from the patient Before placing the scan template or drill guide into the patients mouth make sure to prepare such template or guide according to dental standard operating procedures and the instruction for use provided for your material Bone loss values output by coPeriodontiX are calculated values rep resenting the distance between the points set by the user and are not intended for diagnostic use The clinician should confirm actual prob ing depth measurements by physical examination It is the sole responsibility of the user to make sure that accessories and products used in combination with coDiagnostiX are intended to be used for such purpose Follow their instructions for use Protect your data against loss unauthorized access and unauthor ized use Secure your computer system by installing a malware scanner or
14. ange The user Is obliged to study the latest developments of coDiagnostiX regularly ABOUT THIS GUIDE Product life cycle The product life cycle of coDiagnostiX software Is 3 years After ex piration of this time the software may continue to function properly as long as configuration or hardware are not modified However legal and regulatory requirements change at regular inter vals The legal manufacturer does therefore not ensure compliance with the regulatory framework beyond the product life cycle period of 3 years Update your software after the end of its product life cycle to maintain regulatory compliance Input data The performance of coDiagnostixX depends on the quality and ac curacy of the CB CT scan as well as the model scan imported The user IS Solely responsible to ensure that the quality of the imported data is sufficient for proper performance of coDiagnostiX Relevant anatomical structures must be visible in the above scans CB CT devices have to comply with the recommendations of ICRP97 Inter national Commission on Radiological Protection Third party products and product data When planning patient cases with coDiagnostiX M and during the practical implementation of such planning the user may work with third party products and or product data Dental Wings GmbH its subsidiaries or distribution partners disclaim any liability for dam ages In connection with or arising from such third party
15. ccordingly do not use the EASY mode to plan datasets with reference pins in both jaws maxilla and mandible Automatic reference pin detection does not guarantee exact and ac curate results Make sure to always verify automatically detected ref erence pins manually 22 INTRODUCTION AND OVERVIEW Always visually check and verify the correctness and accuracy of ref erence pin detection If pin detection is not clear due to poor image quality the dataset must not be used Always maintain an appropriate distance around the implant Printouts containing images of the dataset are not intended for dia gnostic purposes Patient data presented on the iPad are intended for presentation purposes only Do not use such data for diagnostic purposes The gonyX verification should be printed directly from coDiag nostiX M to a calibrated printer Correct dimensioning of the digital drill guide and the selection of appropriate material lie within the sole responsibility of the user Make sure that the inspection windows placed in the digitally de signed drill guide do not affect the stability of the final guide Other wise there Is the risk of inaccurate drilling results which may com promise patient safety When using a drill guide without sleeves never drill directly through the guide Always use appropriate instruments such as drill handles to avoid chipping Inadequate drill guides may result In damage to vital
16. crash or hardware failure o4 SAFETY CHECK 6 DISTRIBUTORS AND SERVICE In case of questions please contact your local distributor Alternat ively contact coDiagnostiX support adental wings com in English or German DISTRIBUTORS AND SERVICE 90 7 SYMBOLS ON THE PRODUCT AND OR PACKAGING 06 Caution consult instructions for use for im portant cautionary information Consult instructions for use Caution Federal law restricts this device to sale by or on the order of a licensed health care practitioner The CE sign indicates that the product complies with applicable EU regulations Indicates the medical device manufacturer SYMBOLS ON THE PRODUCT AND OR PACKAGING www dentalwings com www codiagnostix com asl Dental Wings GmbH Duesseldorfer Platz 1 D 09111 Chemnitz Germany Dental Wings GmbH 2015 All rights reserved coDiagnostix 9 INSTRUCTIONS FOR USE 02 02 2015 P003 02 v8
17. ction STEP BY STEP CASE PLANNING 43 4 8 Plan sleeves s Select your implant in the object tree and click the Edit Sleeves icon he dialog box opens s Select a sleeve system from the list u Adjust the parameters as desired Observe all instructions provided by the sleeve system manufacturer Generic sleeve system coDiagnostiX offers a generic sleeve system This system works with presets and can be used to define and configure sleeve systems which are not pre installed For a detailed description see the coDiagnostiX M Help Thoroughly verify all data before storing or using a preset for a generic sleeve system A Caution Please be aware that the user of coDiagnosti XA M software is solely responsible for the correct ness accuracy and completeness of al data entered into the coDiagnostiX M software 44 a goonsetry parameters oe parameters epecfying the sieeve geometry These values affect he aperane of Ze Seeve the Laad the respective tiange mesh model for each sleeve Sleeves beer o Af es 7 g 55m 2 Length See of Arpce number STEP BY STEP CASE PLANNING 4 9 Design digital drill guide This step is used in the digital workflow only Preparation Complete your planning Scan the master model and import this scan The model scan must not Include any wax up or prosthetic setup s Match the model scan and the corresponding segmentation
18. d Color depth should be 32 bit true color The maximum resolution per view 3D reconstruction virtual OPG etc is 4096 x 3072 pixels 2 2 3 2 Input data requirements The software supports a wide range of image sources Including Computed Tomography CT and Cone Beam Computed Tomography CBCT as well as model scans from different sources It is also pos sible to work with other sliced image data or volume data INTRODUCTION AND OVERVIEW Supporting information for CB CT scans The production of CB CT scans lies within the full responsibility of the radiologist or appropriately qualified personnel However the fol lowing requirements have to be observed to support image data pro cessing and implant planning with coDiagnosti X M Preparation All metal parts which are not fixed must be removed from the pa tients mouth When using the analog workflow with the gonyX the patient must wear a scan template with reference pins during radiology The reference pins must be completely visible in the CB CT scan one slice above the pin is sufficient Make sure that all components attached to the scan template are firmly fixed Before placing the scan template into the patients mouth make sure to prepare such template according to dental standard oper ating procedures and the Instruction for use provided for your ma terial Block the opposite jaw with dental cotton rolls or adequate non ra diopaque material P
19. d hold the shift key to move the whole panoramic curve STEP BY STEP CASE PLANNING 4 3 Import and match model scan data u Select Object gt Add gt Model Scan from the main menu a Select the model scan file you want to import and open the file a Select the method to align the model scan The standard method Is alignment to another ob ject For other possible alignment options see the coDiagnostiX M Help Select the registration object volume seg mentation previously imported model scan to use for matching Model scan and registration object must cover analogous anatomical re gions Define pairs of corresponding regions by click ing the affected region both on the model scan and on the registration object For partially edentulous cases use the re maining teeth For edentulous cases use temporary Iim plants Pairs of corresponding regions should not lie on an approximately straight line and must be set at anatomically significant positions and as far away from each other as possible STEP BY STEP CASE PLANNING Do cet sen Liy tha wed kes ee bad masc Ier a te hee 37 s Click Next to perform automatic registration Thoroughly check the congruency of the con tours of the merged 3D objects in all views to ensure correct and accurate alignment of both objects upon import Matching of model scan data Is a prerequisite for digital drill guide design Matching accuracy directly
20. e used Always maintain an appropriate safety distance to the nerve canal STEP BY STEP CASE PLANNING Y ann 4 9 Detect gonyX reference pins gonyX registration is required for the analog workflow only e Click the gonyX Registration icon Use the Automatic Search button to start automatic pin detection Check your pin detection result for each refer ence pin To do so activate the reference pin in the work panel and check in each single view the correct alignment of the blue pin with the white pin in the scan AdJust as neces sary Adjusting reference pins with the mouse Move the reference pin with the left mouse button Rotate the reference pin with the right mouse button Confirm reference pin validation 40 STEP BY STEP CASE PLANNING Registration reliability The indicator shows the quality of reference pin registration Sufficient quality Insufficient quality No pin registration pos sible Yellow Poor quality Re check pin positioning In crease safety distances in planning to make allowance for possible inaccuracies A Caution Datasets with reference pins in both jaws max illa and mandible The automatic pin detection of coDiagnostiX EASY cannot distinguish between pins in the maxilla and those in the mandible when scanned together This can res ult in Inaccurate planning Accordingly do not use the EASY mode to plan datasets wit
21. gh the internet An archiving system to backup patient and planning data An on demand anonymization function for privacy protection Please bear in mind that the user Is responsible for data protection on user side INTRODUCTION AND OVERVIEW 25 Caution Protect your data against loss unauthorized access and unauthor ized use Secure your computer system by installing a malware scanner or firewall Use a strong password to protect your computer system storage media and presentation devices Use data encryption to secure data on your computer system and storage media Backup your data regularly Use the anonymization function to protect patient personal data If required 2 9 Further information a gonyX Lab Manual s coDiagnostiX M Help 2 10 Installation LL Note Do not plug the dongle into the computer until you are prompted to do so by the installation program Steps for installation 1 Insert the installation medium into the computer 2 If the installation process does not start automatically start the program manually by executing the file setup exe on your instal lation medium 3 Follow the instructions on the screen 26 INTRODUCTION AND OVERVIEW 2 11 Disposal Use existing disposal systems to dispose of the data carriers and their packaging INTRODUCTION AND OVERVIEW 27 3 USER INTERFACE AND coDiagnostiX BASICS The software user interface is ba
22. h refer ence pins in both jaws maxilla and mandible Automatic reference pin detection does not guarantee exact and accurate results Make sure to always verify automatically detected ref erence pins manually Always visually check and verify the correctness and accuracy of reference pin detection If pin detection is not clear due to poor image quality the dataset must not be used STEP BY STEP CASE PLANNING Registration reliability iss haan 41 4 6 Plan implant Click the Add Implant icon The Implant Data base opens a Select the implant and the tooth position s where the implant s shall be placed Click OK and the database closes Adjust the implant position The positioning mode is already activated Adjusting the implant Move the implant with the left mouse button Rotate the implant with the right mouse but ton To support correct implant positioning align the views with the implant axis This allows you to rotate 360 around the implant in the tangential view Always verify the correct position of the implants A Caution Always maintain an appropriate distance around the implant 42 SOMOU TIAN UO 9 m STEP BY STEP CASE PLANNING 4 7 Plan abutments s Select an implant in the object tree s Click the Edit Abutments icon he dialog box opens Switch to the Database tab and select the de sired abutment Click OK to apply your sele
23. irec tion cement enamel junction apical point bony pocket base This way four points can be set In one sectional plane The current point to be defined is illustrated in the chart on the right side both graphically and dS text 90 STEP BY STEP CASE PLANNING Results Radiographic vertical bone loss values are calcu lated and grouped in categories Ranges for the categories can be defined by the user with the cogwheel button Print results coPeriodontiX offers two types of print reports Results Screenshots s Click the Print Report button to select the type of print report you want to output results or screenshots s Click the Print button to print your results or Save as PDF N Caution Printouts containing images of the dataset are not intended for diagnostic purposes STEP BY STEP CASE PLANNING WEFFFFFFFFUFZE AI a a 9 SAFETY CHECK v Always align all 2D views with the implant axis and rotate around the implant to ensure cor rect positioning and to avoid any collisions BREET ue oll Lei Lj i d U ev Tangential we u OK Ze L he v Always consult collision warning and critical nerve distance warning Implant verification Bone density 2 606 HU Distance to other implants Distance to neve canal Distance collision warnings will be displayed
24. ispatcher Port 55555 UDP Broadcast query Additional requirements for the coDiagnostiX Network Database Working with the Network Database SQL module requires a Mi crosoft SQL Server Additional requirements for the coDiagnostiX Network License e An additional computer with a free USB slot running Microsoft Windows which acts as a dongle server a server running 24 7 is recommended but not necessary A permanent W LAN connection to the dongle server while run ning coDiagnostiX on the client computer Optional Shared network drive to store the database INTRODUCTION AND OVERVIEW Network configuration requirements caseXchange Client port 80 outgoing s Online Updater Client port 80 outgoing Network Database SQL To configure your network for use with SQL Server see the infor mation provided by Microsoft or contact your Dental Wings support e Network dongle Client TCP port 54237 UDP port 21945 both outgoing Server TCP port 94237 UDP port 21945 both incoming Additional requirements for running coDiagnostiX on Apple Mac OS X e Macintosh computer with Intel processor a Mac OS X 10 9 or newer a Parallels Desktop or VMWare Fusion for Macintosh including valid Windows license software to be purchased separately Screen resolution requirements For optimum usability of coDiagnostiX M a screen resolution of 1680 x 1050 pixels or higher with 96 dpi is recommende
25. ix Digital workflow using 3D manufacturing systems 3D manufacturing system There are many ways to produce drill guides with 3D manufacturing systems e g 3D printing system or milling machine provided the manufacturing system can read STL files and process biocompatible material 14 INTRODUCTION AND OVERVIEW The digital workflow has been validated with the following materials and 3D manufacturing systems example Objet Eden260V printer and Med610 material Rapid prototyping machine D30N2 SN3 with FotoDentLED Aim plant as material FORMIGA P110 laser sintering system with synthetic powder ma terial PA 2200 Each 3D manufacturing system which fulfills the reguirements above may In principle be suitable The user needs to ensure that the drill guide can be produced with sufficient accuracy and that the material used for fabrication is suitable for the use as a drill guide in patients 2 2 3 1 Computer hardware and software reguirements The following requirements are the minimum requirements recom mended for smooth operation of coDiagnostiX However under certain circumstances the software might also run on other configur ations RAM 8 GB Hard disk 1 GB of free storage space for installation and ap prox 90 MB per patient case Monitor with minimum screen resolution of 1024 x 768 pixels Keyboard and 2 button mouse mouse with scroll wheel recom mended DVD drive One free USB port Opera
26. l views and fits contents to the view box in all views Toggles the visibility of the Reference lines in all 2D views Aligns the cross sectional tangential and axial views with the axis of the currently selected implant at least one implant has to be planned USER INTERFACE AND coDiagnostiX BASICS 31 3 3 Object tree The object tree contains a Tree functions e g add delete a All the objects e g implants sleeves nerve canals measurements model scans drill guides a Tooth position panel currently selected tooth position Provides all the Information on the implant abutment sleeve and or virtual tooth for the given tooth position and allows to adjust them s Density statistics Moving rotating objects Select object in the object tree Activate the positioning mode Move object with the left mouse button Rotate object with the right mouse button some objects only Objects most important tree functions Description Adds a new object e g implant measurement Enables disables the positioning mode As long as the positioning mode is not activated the ob jects cannot be touched with the mouse Deletes the selected object ER Y Digital drill guides Digital Drill Guide Y O Surface scans and 3D models Mandible W Nerve canals KE Left nerve canal Right nerve canal Y O View definition C Panoramic curve Patient coordinate syste
27. m Y Segmentations Default Mandible USER INTERFACE AND coDiagnostiX BASICS 3 4 Plans Working with different plans Planning data are managed in plans You may create several plans for one patient Use the combo box to browse your plans Plans can be a Newly created deleted and copied select from the Plan menu a Protected against changes select Plan gt Properties from the main menu and tick Protect this plan against changes Such protection Is reversible e Finalized select Plan gt Finalize from the main menu No further modifications will be allowed Create a copy of the plan If you have to change something subseguently USER INTERFACE AND coDiagnostiX BASICS t Mandible Properties Management New Ctrl Shift N Create Copy Delete Finalize Edit Send Print Surgical Protocol Straumann e shop Import Prosthetic Design Virtual Planning Export Treatment Evaluation 33 4 STEP BY STEP CASE PLANNING Starting coDiagnostiX and loading a DICOM case s Start the coDiagnostiX software ensure that the dongle is connected s Insert the DICOM data you received from the CB CT scanner into the computer s disc drive N Caution Please be aware that the user of coDiagnostix software is solely responsible for the correct ness accuracy and completeness of all data entered into the coDiagnostiX M software 34 STEP BY STEP CASE PLANNI
28. manufactur ing system as well as the correct fabrication of scan templates and drill guides lie within the sole responsibility of the user coDiagnostiX is not intended to be used in direct contact with the patient or with life sustaining devices Dental Wings products must be used In accordance with their ac companying instructions for use Improper use or handling of Dental Wings products will void the warranty If any given for Dental Wings products If you require additional information on the proper use of Dental Wings products contact your local distributor The user Is not allowed to modify Dental Wings products DENTAL WINGS GMBH ITS AFFILIATES OR DISTRIBUTORS DISCLAIM REPRESENTATIONS AND WARRANTIES OF ANY KIND WHETHER EXPRESS OR IMPLIED WRITTEN OR ORAL WITH RESPECT TO THE PRODUCTS INCLUDING ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE ERROR FREE OPERATION OR NON INFRINGEMENT AND THE PRODUCTS ARE SOLD AS IS Our maximum liability arising out of the products or their use whether based upon warranty contract tort or otherwise shall not exceed the actual payments received by us in respect of the purchase price thereof In no event shall we be liable for special incidental or consequential damages including but not limited to loss of profits loss of data or loss of use damages arising hereun der or from the sale of the products Please note that coDiagnostiX software Is subject to ch
29. model scan data u The precision of aligning model scan data with CB CT data by the user 46 Visualization STEP BY STEP CASE PLANNING Errors in design of the drill guide software model such as using Incorrect sleeves or Inac curate sleeve placement Errors in production of drill guide by the labor atory Failure to check fit of the drill guide on the model prior to use Failure to check fit of the drill guide on the pa tient prior to surgery Drill guide incorrectly placed in the patient s mouth resulting in Inaccurate fit and inter op erative movement Inaccurate fit of the guided surgical instru ments with the sleeves of the drill guide in strument wear or Incorrect sleeve selection can result in a loose fit and positional inaccur acy N Caution Correct dimensioning of the digital drill guide and the selection of appropriate material le within the sole responsibility of the user Make sure that the Inspection windows placed In the digitally designed drill guide do not affect the stability of the final guide Otherwise there is the risk of inaccurate drilling results which may compromise patient safety When using a drill guide without sleeves never drill directly through the guide Always use ap propriate instruments such as drill handles to avoid chipping Please note that you are also responsible for the selection of an appropriate and calibrated 3D manufacturing system and the co
30. ositioning Align the occlusal plane to the scan plane as accurately as pos sible Important CT scanning parameters u A gantry angle of 0 is recommended to achieve the best quality for image reconstruction e Do NOT vary reconstruction parameters within a series constant value for X and Y axis a Set a high resolution bone algorithm actual setting depends on the device a Parameters for a complete dataset when using dynamic mode Slices 0 5 mm to 1 0 mm 0 5 mm recommended a When using spiral mode reconstruction to 1 0 mm slices or less 0 5 mm is recommended INTRODUCTION AND OVERVIEW KV approx 110 to 130 a mA approx 20 to 120 Storage of image data s Only axial slices are required e DICOM Ill format no raw data Visualization of motion artifacts In case of CT scans with scan template motion artifacts can be visu alized by attaching a scan control bar available as accessory to the template prior to scanning The performance of coDiagnostiX depends on the quality and ac curacy of the imported CB JCT and model scans The user is solely responsible to ensure that the quality of the imported data Is suffi cient for proper performance of coDiagnostiX Relevant anatomical structures must be visible in the scans CB CT devices must comply with the recommendations of ICRP97 International Commission on Radiological Protection 2 2 3 3 General operating and storage conditions To ensure
31. product data or products being used within this scope ABOUT THIS GUIDE 1 2 License trademarks and copyright Software license coDiagnostiX software Is protected by a License Agreement and may be used or copied only in accordance with the terms of this agreement It is illegal to copy or use coDiagnostiX software on any medium except those permitted in the License Agreement Some of the features offered by coDiagnostiX may require an addi tional license on your dongle Contact your local distributor for more information Availability Some of the products mentioned in this guide may not be available in all countries Trade names and trademarks DWOS coDiagnostiX M and gonyX are trademarks or registered trademarks of Dental Wings Straumann and CARES are registered trademarks of Straumann Holding AG Switzerland Microsoft SQL Server Windows Windows XP and Windows Vista are registered trademarks of Microsoft Corporation USA Intel Core is a trademark of Intel Corporation registered in the U S and or other countries Athlon is a trademark of Advanced Micro Devices Inc USA Macintosh Mac Mac OS and iPad are trademarks of Apple Inc registered in the U S and other countries App Store is a service mark of Apple Inc registered in the U S and other countries eToken M is a trademark of SafeNet Inc USA ABOUT THIS GUIDE CAMLOG is a registered trademark of
32. rogram steps A Caution Bone loss values output by coPeriodontiX are cal culated values representing the distance between the points set by the user and are not intended for diagnostic use The clinician should confirm actual probing depth measurements by physical examination Open the module to start periodontal charting e Click Open dataset on the start screen u Select the dataset and choose the Open with coPeriodontiX option at the bottom of the dia log box STEP BY STEP CASE PLANNING Name Patient 9 coPeriodontiX Date of birth n a PatientID nya Checked in 09 03 2011 13 29 30 Additional patient information Open with coPeriadantiX 49 Define panoramic curve a Select the type of jaw maxilla or mandible s Define the panoramic curve by placing panor amic curve points see chapter Panoramic Curve Define the tooth coordinate system The coordinate system can be moved with the left mouse button and rotated with the right mouse button Carry out the following steps for each tooth posi tion u Select the tooth position in the dental chart Roughly position the coordinate system by clicking the desired tooth in the virtual OPG s Fine align within the three basic planes Set measuring points Calculation is performed starting from the tooth axis in six directions vestibular oral vestibular distal oral mesial vestibular mesial oral distal Two points are captured for each d
33. rrect fabrica tion of the drill guide STEP BY STEP CASE PLANNING 4 10 Print protocols Click on the arrow of the Print icon in order to open the menu Most important print protocols Template plan Required for drill guide fabric ation with gonyX analog workflow only gonyX verification Required to check the setting of the gonyX coordinates and to verify the final drill guide analog workflow only Surgical protocol Protocol for using the guided instruments of Straumann CARES Guided Surgery Print all Defines a selection of protocols to be printed in one step N Caution Printouts containing images of the dataset are not intended for diagnostic purposes The gonyX verification should be printed dir ectly from coDiagnostiX M to a calibrated printer Note that a gonyX verification protocol that Is not printed on a calibrated printer but saved as PDF instead will not be calibrated 49 Material list Material list all plans Details Details all plans Template plan gonyA verification Surgical protocol Print screenshot Print all STEP BY STEP CASE PLANNING 4 11 coPeriodontiX coPeriodontiX is a user friendly tool to calculate the distance between the cement enamel junc tion and the bone level in six directions This is done with the help of high resolution CB CT data The module offers a workflow which guides the user through the individual p
34. sed on the Mi crosoft Windows standard allowing you to con trol the system easily by mouse To become famil iar with the system and the control elements such as buttons check boxes and edit controls consult the user manual of your operating system Create dataset DICOM cy Opens the DICOM Transfer dialog box to im E dental wings port DICOM data e g from a CD and to cre ate a patient dataset Open dataset Opens the Patient Database DICOM already imported coDiagnostix coDiagnostiX Management C coDiagnostiX M Management provides access to a lot of administrative functions such as backup or language setting Archiving and restoring datasets In different versions of coDiagnostiX can cause compat ibility problems Main menu Provides access to database related functions other modules or License Management Updates and remote support Shows information about updates and provides access to remote support active in ternet connection reguired 29 USER INTERFACE AND coDiagnostiX BASICS 3 1 Toolbar Patient Plan Object View Extras 7 ER Tools of the interactive planning workflow Basic tools for view manipulation Menu with complete set of functions Customizing the toolbar Right click on the toolbar and select Adjust to open the dialog box f necessary use the combo box to toggle between the presets for the analog or digital workflow
35. ting system Microsoft Windows 8 64 bit recommended other supported operating systems Microsoft Windows 8 32 bit Windows 7 64 bit and 32 bit PDF reader INTRODUCTION AND OVERVIEW Optional components a DVD burner a Printer u Internet connection An internet connection is required for instance for online updates remote support online transfer and DWOS Synergy e Network connection A network connection is required for using the optional Network Database SGL or Network License Additional reguirements for DWOS Synergy s coDiagnostiX version 9 5 or higher e DWOS version 4 0 or higher DWOS Synergy network configuration s Install at least one Synergy server within your network For infor mation on where to download the latest local Synergy server re lease contact coDiagnostiX M customer support see DISTRIBUTORS AND SERVICE lo be able to reach the Synergy server from other clients activate the following ports Por kend RabbitMQ server administration interface Port 61613 STOMP protocol communication with Incoming coDiagnostix INTRODUCTION AND OVERVIEW Port 80 HTTP protocol Synergy over the internet Outgoing N ot reguired for communication with local Synergy server Port 443 SSL protocol Synergy over the internet Not Outgoing required for communication with local Syn ergy server Port 61613 STOMP protocol communication with Outgoing coDiagnostix Port 61615 STOMP message gueue d
36. valid for the product life cycle of coDiagnostiX 9 unless new instructions are published within this period These Instructions for Use contain Important information for the safe and appropriate use of coDiagnostiX M Make sure to have read and understood this document prior to working with the software In case of questions contact the manufacturer Please keep this document for future reference Electronic Instructions for Use coDiagnostiX M 9 Instructions for Use are provided in electronic form A paper version can be requested from the manufacturer For fur ther information and contact details see http codiagnostix com ifu 1 1 Disclaimer coDiagnostiX software Is designed for use by persons who have ap propriate knowledge in implantology and surgical dentistry To run the software users must also have basic skills In operating a com puter The user of coDiagnostiX M is solely responsible for determining whether or not any product or treatment is suitable for a particular patient and circumstances The user of coDiagnostiX is solely re sponsible for the correctness completeness and adequacy of all data entered into coDiagnostiX software The user has to check the cor rectness and accuracy of planning with coDiagnostix software and to assess each individual case ABOUT THIS GUIDE Correct dimensioning of the digital drill guide the selection of ap propriate material and an appropriate and calibrated 3D
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