English - coDiagnostiX
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1. Dental Wings GmbH 2013 All rights reserved2. coDiagnostiX 8 6 INSTRUCTIONS FOR USE ZZ dental wings CONTENTS 1 ABOUT THIS GUIDE 5 2 INTRODUCTION AND OVERVIEW 8 2 1 Intended use oo y y y y 8 2 2 Device description and features 8 8 2 2 1 Device variants and configuration 2 2 2 Principles of operation 9 2 2 3 Accessories and products used in combination 10 2 3 Indications dE dd Contraindications 14 2 5 Precautions 14 2 6 Compatibility information 16 2 7 Further information 16 2 8 Installation 16 3 USER INTERFACE AND coDiagnostiX BASICS 17 3 1 Toolbar 18 3 2 Views 19 3 3 Object tree st 34 Plans 22 4 STEP BY STEP CASE PLANNING 23 4 1 Define panoramic curve 24 42 Detect nerve canal 25 4 3 Detect gonyX reference pins 26 44 Planimplant 27 4 5 Plan abutments 28 46 Plan sleeves 29 4 7 Print protocols 30 5 SAFETY CHECK 31 6 DISTRIBUTORS AND SERVICE 33 7 EXPLANATION OF THE SYMBOLS ON LABELS OR LEAFLETS 34 coDiagnostiX 8 6 INSTRUCTIONS FOR USE Dental Wings GmbH 1 ABOUT THIS GUIDE These Instructions for Use are valid for the product life cycle of coDiag nostix 8 6 unless new instructions are published within this period Electronic Instructions for Use coDiagnostix 8 6 Instructions for Use are provided in electronic form A pa per version can be requested from the manufacturer For further information and contact details see http codiagnostix com ifu Disclaimer coDiagnostix software is designed for use by persons who
3. PLANNING 4 6 Plan sleeves e Select your implant in the object tree and click the Edit Sleeves icon e The dialog box opens e Select a sleeve system from the list Adjust the parameters as desired Observe all instructions provided by the sleeve system manufacturer Thoroughly verify all data before storing or using a preset for a generic sleeve system A Caution Please be aware that the user of coDiagnostiX soft ware is solely responsible for the correctness accuracy and completeness of all data entered into the coDiag nostix software STEP BY STEP CASE PLANNING Sleeve system Straumann Guided Surgery No sleeve system User defined Straumann Guided Surgery steco system technik GaBler Zahntechnik Generic sleeve system Sleeve position H2 2 mm Drill length Drill handle Milling cutter 29 4 7 Print protocols Click on the arrow of the Print icon in order to open the menu Most important print protocols Template plan Required for surgical template fab rication with gonyX gonyX verification Required to check the setting of the gonyX coordinates and to verify the final surgical template Surgical protocol Protocol for using the guided in struments of Straumann CARES Guided Surgery Print all Defines a selection of protocols to be prin ted in one step Caution Printouts containing images of the dataset are not in te
4. Limitations regarding screen resolution For optimum usability of coDiagnostix a screen resolution of 1680 x 1050 pixels resp 1280 x 1024 pixels for monitors 4 3 or higher with 96 dpi is re commended Color resolution should be 32 bit true color The maximum res olution 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 Digital Volume Tomography DVT as well as surface intra oral IO and impression scans from different manufacturers It is also possible to work with other sliced image data or volume data Supporting information for CT DVT scans The production of CT DVT scans lies within the full responsibility of the radi ologist or appropriately qualified personnel However the following require ments have to be observed to support image data processing and implant planning with coDiagnostix 12 INTRODUCTION AND OVERVIEW Preparation e All metal parts which are not fixed have to be removed from the patient s mouth e When using the analog workflow with the gonyX have the patient wear a scan template with reference pins during radiology The reference pins have to be completely visible in the CT DVT scan one slice above the pin is sufficient e Make sure that all components attached to the scan template are firmly fixed e Clean or disinfect the template before pla
5. The object tree contains e Tree functions e g add delete All the objects e g implants sleeves nerve canals measurements e Comment field e Tooth position pane currently selected tooth posi tion Provides all the information on the implant abut ment sleeve and or virtual tooth for the given tooth position and allows to adjust them e 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 ob jects 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 USER INTERFACE AND coDiagnostix BASICS Plan Mandible E Tooth positions y LA 37 gt ZG Augmentations E Nerve canals ZO t mer EO E O View definition E Segmentations Symbol 21 3 4 Plans Working with different plans Planning data are managed in plans You may cre ate several plans for one patient Use the combo box to browse your plans Plans can be e Newly created deleted and copied select from the Plan menu e Protected against changes select Plan gt Prop erties from the main menu and tick Protect this plan a
6. and accurate results Make sure to always verify automatically detected reference 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 26 Change pin gt OO Automatic search Align pins x Delete all pins Registration reliability STEP BY STEP CASE PLANNING 4 4 Plan implant Click the Add Implant icon The Implant Database opens e Select the implant and the tooth position s where the implant s shall be placed Click OK and the database closes e 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 button 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 STEP BY STEP CASE PLANNING d 27 4 5 Plan abutments 28 Select an implant in the object tree Click the Edit Abutments icon The dialog box opens Switch to the Database tab and select the desired abutment Click OK to apply your selection Artide no 022 4104 Straumann RC Anatomic Artide no 022 4154 Artide no n a STEP BY STEP CASE
7. ark 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 re gistered 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 is a trademark of SafeNet Inc USA CAMLOG is a registered trademark of 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 Materialien Fach und Organisationsberatung Peter Brehm 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 2 INTRODUCTION AND OVERVIEW 2 1 Intended use coDiagnostiX is intended to be used as preoperative planning software for dental implant placement 2 2 Device description and features coDiagnostix is a 3D implant planning software allowing the import and processing of the 3D CT DVT scan dataset DICOM standard Based on the finalized implant planning the software allows for export of data for the pro duction of surgical templates using the analog gonyX table In the analog workflow the patient has to wear a scan template with reference pins during the CT DVT scan Working with t
8. cing it in the patient s mouth Positioning e Align the occlusal plane to the scan plane in the best way possible Important CT scanning parameters e A gantry angle of 0 is recommended to achieve the best quality for image reconstruction Block the opposite jaw bone using plastic material or cotton wool pads to avoid artifacts around the reference pins Do NOT vary reconstruction parameters within a series constant value for X and Y axis e Set a high resolution bone algorithm Inner Ear Bone High No EDGE Siemens e g AK 97 Elscint e g Ultra High etc e Parameters for a complete dataset when using dynamic mode Slices 0 5 mm to 1 0 mm e When using spiral mode reconstruction to 1 0 mm slices or less is recom mended KV approx 110 to 130 MA approx 20 to 120 Storage of image data e Only axial slices are required e DICOM II format no raw data Visualization of motion artifacts In case of CT scans with scan template motion artifacts can be visualized with the help of a scan control bar INTRODUCTION AND OVERVIEW 13 2 3 Indications coDiagnostix is an implant planning and surgery planning software tool in tended for use by dental professionals who have appropriate knowledge in implantology and surgical dentistry This software reads imaging information output from medical scanners such as CT or DVT scanners It allows preoper ati
9. combination The following products and accessories can be used in combination with coDiagnostix software Analog workflow using gonyX and its accessories gonyX Device for scan and surgical template fabrication by the dental laboratory gonyX accessories include Reference pin and templix reference plate Devices for scan template production Scan control bar Additional device for enhancement of quality of CT DVT scans Generic sleeve positioner including closing lid Device for sleeve positioning with gonyX 10 5 Surgical template fabrication 6 Guided Surgery and implant insertion INTRODUCTION AND OVERVIEW 2 2 3 1 Computer hardware and software requirements The following requirements are the minimum requirements recommended for smooth operation of coDiagnostiX However under certain circumstances the software might also run on other configurations Processor Intel Core or AMD Athlon 64 X2 Main memory 3 GB Hard disk 1 GB of free storage space for installation and approx 50 MB per patient case Monitor Text input device e g keyboard Pointing device e g mouse DVD drive One free USB port Minimum screen resolution 1024 x 768 pixels Operating system Microsoft Windows 7 recommended other supported operating systems Microsoft Windows XP Vista PDF reader Adobe Reader XI Optional components DVD burner Printer Internet connection An internet co
10. e 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 installation medium 3 Follow the instructions on the screen 16 INTRODUCTION AND OVERVIEW 3 USER INTERFACE AND coDiagnostiX BASICS The software user interface is based on the Microsoft Windows standard allowing you to control the system easily by mouse To become familiar with the system and the control elements such as buttons check boxes and edit controls consult the user manual of your op erating system Create dataset DICOM Opens the DICOM Transfer dialog box to import DICOM data e g from a CD and to create a pa tient dataset E Open dataset Opens the Patient Database DICOM already im ported E coDiagnostiX Management coDiagnostix Management provides access to a lot of administrative functions such as backup or language setting Archiving and restoring datasets in different ver sions of coDiagnostix can cause compatibility problems EN 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 internet connec tion required USER INTERFACE AND c
11. gainst changes Such protection is re versible 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 subsequently 22 Plam i Mandible t Maxilla Patient Plan Object View Extras Properties Management New Ctrl Shift N Delete Create Copy Finalize Send Print Surgical Protocol Straumann e shop Create coViewer Disc Import Prosthetics Virtual Planning Export Digital Drill Guide Creation Treatment Evaluation E Augmentations 0 29 ml USER INTERFACE AND coDiagnostix BASICS 4 STEP BY STEP CASE PLANNING Starting coDiagnostiX and loading a DICOM case Start the coDiagnostix software ensure that the dongle is connected Insert the DICOM data you received from the CT DVT scanner into the computer s disc drive Click Create dataset DICOM on the start screen Select Import data from CD DVD and click Import Incase of any problems error messages warnings etc contact customer service e Choose if you would like to plan a case for maxilla or mandible To plan both maxilla and mandible you need to generate two separate plans coDiagnostiX switches to the standard planning screen Caution Please be aware that the user of coDiagnostiX soft ware is solely responsible for the correctness accuracy and completeness of all data entered into the c
12. have appropri ate knowledge in implantology and surgical dentistry The user of coDiagnostiX is solely responsible for determining whether or not any product or treatment is suitable for a particular patient and circum stances The user of co DiagnostiX is solely responsible for the correctness completeness and adequacy of all data entered into coDiagnostiX software The user has to check the correctness and accuracy of planning with coDiag nostix software and to assess each individual case The selection of appropriate material as well as the correct fabrication of scan or surgical templates 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 accompanying 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 ad ditional information on the proper use of Dental Wings products contact your local distributor 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 ABOUT THIS GUIDE Our max
13. he software is based on a patient s medical image data such as a CT Computed Tomography and DVT Digital Volume Tomography that is processed by coDiagnostix after being transferred via CD DVD network or various other storage mediums Planning is performed by the calculation of several views such as virtual OPG or a three dimensional reconstruction of the image dataset by the analysis of the image data and the placement of implants abutments and drilling sleeves 2 2 1 Device variants and configuration coDiagnostiX is available in a full version and a client version The Client is assigned to a coDiagnostiX full version and can communicate and export template data only through the assigned full version coDiagnostiX is an open software system The library contains implant abutment and sleeve systems from several major manufacturers For surgical template fabrication with the gonyX a template plan from coDiagnostix is required INTRODUCTION AND OVERVIEW 2 2 2 Principles of operation Implant planning with coDiagnostixX is part of a guided surgery workflow 2 2 2 1 Analog workflow The master model represents the patient situation and is the basis for the production of the scan and surgical template 2 5 The scan template contains information about the de sired prosthetic outcome in form of radiopaque teeth visible in CT DVT scan 3 The scan template has to be connected to the templiX
14. iX will automatically detect the nerve canal 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 qual ity the dataset must not be used STEP BY STEP CASE PLANNING 4 3 Detect gonyX reference pins Click the gonyX Registration icon Use the Automatic Search button to start automatic pin detection e Check your pin detection result for each reference pin To do so activate the reference pin in the work pane and check in each single view the correct alignment of the blue pin with the white pin in the scan Adjust as necessary Adjusting reference pins with the mouse Move the reference pin with the left mouse but ton Rotate the reference pin with the right mouse button Confirm and accept reference pin validation Caution Datasets with reference pins in both jaws maxilla and mandible The automatic pin detection of coDiag nostix EASY cannot distinguish between pins in the maxilla and those in the mandible when scanned to gether This can result in inaccurate planning Accord ingly 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
15. imum 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 hereunder or from the sale of the products Please note that coDiagnostiX software is subject to change The user is ob liged to study the latest developments of coDiagnostiX regularly Product life cycle The product life cycle of coDiagnostix software is 3 years After expiration of this time the software may continue to function properly as long as con figuration or hardware are not modified However legal and regulatory requirements change at regular intervals The legal manufacturer does therefore not ensure compliance with the regulat ory framework beyond the product life cycle period of 3 years Declaration of Conformity expires after 3 years Update your software after the end of its product life cycle to maintain regulatory compliance Input data The performance of coDiagnostix depends on the quality and accuracy of the CT and or DVT scan as well as IO model or impression 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 s
16. nded for diagnostic purposes The gonyX verification should be printed directly from coDiagnostiX to a calibrated printer Note that a gonyX verification protocol that is not printed on a calibrated printer but saved as PDF in stead will not be calibrated 30 Material list Material list all plans Details Details all plans Template plan gonyX verification Surgical protecol Print screenshot Print all STEP BY STEP CASE PLANNING 5 SAFETY CHECK v Always align all 2D views with the implant axis and rotate around the implant to ensure correct position ing and to avoid any collisions Cross sectionals GF 1 0 mm IO Tangential v Always consult collision warning and critical nerve distance warning it Distance to other sleeves Implant verificatiom Bone density 8 606 EO Distance to other implants Distance to nerve canal SAFETY CHECK v Always verify automatic nerve canal detection manu ally v Always ensure correct fit of scan template during ra diology v Always give the information concerning CT DVT scans accessible via the Help menu in the software to the radiologist before the first scan v Control all automatic functions of the software v After the planning is completed always finalize the plan Plan gt Finalize to ensure that the plan can not be modified later v Check all printouts template plan gonyX verifica tion etc to ensure
17. nnection is required for instance for online updates remote support or online transfer Network connection A network connection is required for using the optional Network Database SQL or Network License Additional requirements for the coDiagnostiX Network Database Working with the Network Database SQL module requires a Microsoft SQL Server Additional requirements for the coDiagnostiX Network License 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 running coDiagnostiX on the client computer Optional Shared network drive to store the database INTRODUCTION AND OVERVIEW 11 Network configuration requirements e caseXchange Client port 80 outgoing e Online Updater Client port 80 outgoing Network Database SQL To configure your network for use with SQL Server see the information provided by Microsoft or contact your Dental Wings support e Network dongle Client TCP port 54237 UDP port 21945 both outgoing Server TCP port 54237 UDP port 21945 both incoming Additional requirements for running coDiagnostiX on Apple Mac OS X Macintosh computer with Intel processor e Mac OS X 10 6 or newer e Parallels Desktop for Macintosh including valid Windows license soft ware to be purchased separately
18. oDiag nostix software Do not use datasets which can be created in spite of warning messages unless you fully understand 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 DICOM Transfer Transfer DICOM images to database Import data from CD DVD Import data from selected source CAUsers Switch to advanced mode 23 4 1 Define panoramic curve 24 Click the Panoramic Curve icon Grab the points with the left mouse button and move the curve according to the patient s anatomy To create additional points click outside the existing five basic points To delete additional points right click on the point and select Delete Point from the context menu The five basic points cannot be deleted STEP BY STEP CASE PLANNING 4 2 Detect nerve canal e Click the Nerve Canal icon to add the nerve canal objects The positioning mode will be activated automatically e 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 additional points can be added in all views To support nerve canal detection you can set as many nerve canal points as you want and in any view you like e Click Detect in the object tree coDiagnost
19. oDiagnostix BASICS dental wings coDiagnostix 17 3 1 Toolbar Patient Plan Jbject View Extras z ow 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 select Adjust and drag the icon onto or from the toolbar 18 USER INTERFACE AND coDiagnostix BASICS 3 2 Views Views are color coded and can be displayed in other views as reference line with the respective 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 USER INTERFACE AND coDiagnostiX BASICS 19 Manipulating the views most important tools Description Enables disables the Move and Turn tool Enables disables the Localizer tool Enables disables the Zoom tool Resets all views and fits contents to 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 20 USER INTERFACE AND coDiagnostix BASICS 3 3 Object tree
20. plate containing three ref erence pins with the gonyX in order to ensure the link between digital implant planning and surgical tem plate fabrication 4 5 The patient is scanned wearing the scan template with a commercially available 3D CT DVT scanner The user can import the 3D dataset DICOM directly into coDiagnostiX planning software Each implant is positioned with respect to the patient s anatomy and the desired prosthetic outcome After completion of implant planning the software provides the plan for surgical template production with the gonyX 5 as well as further print protocols 6 INTRODUCTION AND OVERVIEW 1 Master model fabrication 2 Scan template fabrication 3 CT DVT scanning 4 3D implant planning The surgical template is produced with the gonyX ac cording to the template plan that is provided by coDiagnostix for each implant 4 The surgical tem plate contains the surgical sleeves that guide the sur gical instruments and the implant 6 There is no need to produce a new template If desired the scan tem plate 2 can be reworked into the surgical template During guided surgery the surgical template 5 is fixed in the patient s mouth Implant bed preparation and guided implant insertion is done using appropri ate guided instruments which have to be compatible with the used implant and sleeve systems 2 2 3 Accessories and products used in
21. that they belong to the corres ponding finalized plan 32 coDiagnostix Version 9 0 Licensed to Institut Straumann AG 800 Patient data Name Patient 6 Date of birth 19591231 Patient ID 00143103 Plan Mandible 1 SAFETY CHECK 6 DISTRIBUTORS AND SERVICE In case of questions please contact your local distributor Alternatively con tact coDiagnostiX support dental wings com in English or German DISTRIBUTORS AND SERVICE 33 7 LOT REF R 34 Rx only EA Batch code Catalog number Sterilized using irradiation Lower limit of temperature Upper limit of temperature Temperature limitation Caution Federal law restricts this device to sale by or on the order of a dental professional Do not re use Non sterile K gt L ez A gt fo JA re ke a a a EXPLANATION OF THE SYMBOLS ON LABELS OR LEAFLETS EXPLANATION OF THE SYMBOLS ON LABELS OR LEAFLETS Caution consult accompanying documents Use by Keep away from sunlight Dental Wings products with the CE mark fulfill the requirements of the respective European Directives see Declaration of Conformity Consult instructions for use Fragile handle with care Keep dry This way up Dental Wings GmbH Duesseldorfer Platz 1 D 09111 Chemnitz Germany www dental wings com coDiagnostiX 8 6 INSTRUCTIONS FOR USE 01 03 2013 P003 02
22. tructures shall be visible in the scan CT and DVT devices have to comply with the recommendations of ICRP97 International Commission on Radiolo gical Protection Third party products Within the scope of coDiagnostix the user works with third party manufac turers products Dental Wings GmbH its subsidiaries or distribution part ners disclaim any liability for damages in connection with or arising from planning with or usage of third party manufacturers products 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 il legal 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 additional li cense 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 ABOUT THIS GUIDE Trade names and trademarks DWOS is a registered trademark of Dental Wings inc Canada coDiag nostix gonyX and caseXchange are trademarks of Dental Wings GmbH Germany Straumann and CARES are registered trademarks of Straumann Holding AG Switzerland Microsoft SQL Server Windows Windows XP and Windows Vista are re gistered trademarks of Microsoft Corporation USA Intel Core is a tradem
23. used in close proximity within a dis tance of 1 5 meters from the patient Make sure to comply with all applicable standards and technical regulations for any computer hardware used to gether with coDiagnostix For example Do not use multiple socket extension cords Do not touch the patient and simultaneously plugs ports or other connect ing parts of the hardware Make sure that computer hardware which is used together with coDiag nostiX is at least 1 5 meters away from the patient Make sure to clean or disinfect the template before placing it in the patient s mouth INTRODUCTION AND OVERVIEW 2 6 Compatibility information Archiving and restoring datasets in different versions of coDiagnostixX can cause compatibility problems Avoid using different versions of coDiagnostix If you have any problems contact customer service In general patient datasets from older versions of coDiagnostix can be opened with coDiagnostix 8 6 backward compatibil ity Check your dataset carefully to avoid minor incompatibilities which might lead to failures in the planning of dental implants and or the production of scan and surgical templates Older versions of coDiagnostix however can not work with datasets from coDiagnostiX 8 6 no forward compatibility of older coDiagnostiX versions 2 7 Further information e gonyX Lab Manual e coDiagnostiX Help 2 8 Installation Note Do not plug th
24. ve simulation and evaluation of patient anatomy and dental implant place ment coDiagnostix provides printouts of template plans for the creation of sur gical templates using a manually operated gonyX table The surgical tem plate as well as a prior scan template are used in direct contact with the pa tient to facilitate accurate image registration within coDiagnostix and the correct positioning and alignment of the implants as planned with the soft ware 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 ra diology compared to conventional x ray can be justified Contraindications applying to other medical devices used within the scope of a guided surgery workflow have to be taken into consideration 2 5 Precautions Please be aware that the user of coDiagnostiX software is solely respons ible 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 messages un less you fully understand the consequences of those warnings and are sure that there will be no unacceptable risk for the correctness and accuracy of your planning Automatic nerve detection does not guarantee exact and accurate nerve canal display Make sure to always verif
25. y the correct position of the nerve canal manually Always verify the correctness and accuracy of nerve canal display 14 INTRODUCTION AND OVERVIEW If nerve definition is not clear due to poor image quality the dataset must not be used Datasets with reference pins in both jaws maxilla and mandible The auto matic 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 with reference 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 reference 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 Printouts containing images of the dataset are not intended for diagnostic 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 coDiagnostiX to a calibrated printer The selection of appropriate material as well as the correct fabrication of scan or surgical templates lie within the sole responsibility of the user coDiagnostiX is not intended to be
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