NemoStudio-Digital-User-Guide-Ed.-24.3-EN.pdf

User Guide 2024 Ed 24.3 EN Legal Manufacturer: Software Nemotec, S.L. Manufacturer Address: Avenida Juan Caramuel, 1. Parque Tecnológico de Leganés 28919 Leganés Madrid...

User Guide 2024 Ed 24.3 EN Legal Manufacturer: Software Nemotec, S.L. Manufacturer Address: Avenida Juan Caramuel, 1. Parque Tecnológico de Leganés 28919 Leganés Madrid Spain. Year of manufacture: 2024 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 1 of 644 Index INTRODUCTION........................................................................................................13 NemoStudio Advantages.........................................................................................14 NemoCast...............................................................................................................15 Disclaimer............................................................................................................16 License, trademarks and other rights...................................................................17 Indications for use................................................................................................17 Contraindications.................................................................................................18 Warnings.............................................................................................................18 Precautions..........................................................................................................19 NemoCeph..............................................................................................................21 Indications for use................................................................................................21 Precautions..........................................................................................................21 NemoFAB and NemoFAB Ortho..............................................................................23 Indications for use................................................................................................25 Warnings.............................................................................................................25 Precautions..........................................................................................................27 Treatment Steps..................................................................................................27 NemoFAB Software Benefits...............................................................................28 NemoScan..............................................................................................................30 Disclaimer............................................................................................................31 License, trademarks and other rights...................................................................32 NemoSmile..............................................................................................................38 Indications for use................................................................................................38 Warnings.............................................................................................................38 Precautions..........................................................................................................40 Contraindications.....................................................................................................40 Reporting a Problem...............................................................................................40 Compatibility information.........................................................................................41 Data protection........................................................................................................41 Further information..................................................................................................42 NEMOUNIVERSITY....................................................................................................43 TECHNICAL REQUIREMENTS..................................................................................45 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 2 of 644 INSTALLATION OF NEMOSTUDIO...........................................................................47 Back-up Files for Desktop mode..............................................................................48 UNINSTALL OF NEMOSTUDIO.................................................................................50 Support...................................................................................................................50 RUN NEMOSTUDIO FOR THE FIRST TIME..............................................................51 OPEN NEMOSTUDIO DESKTOP MODE...................................................................52 Patients on NemoStudio Desktop............................................................................53 Security, Users AND Passwords on NemoStudio Desktop......................................56 Referrers.................................................................................................................58 Enable Security.......................................................................................................59 EXPORT – IMPORT PATIENTS.............................................................................60 Export Patients....................................................................................................60 Import Patients.....................................................................................................64 Send-Receive Cases...............................................................................................70 OPEN NEMOSTUDIO IN WEB...................................................................................72 OPEN NEMOSTUDIO ON CLOUD MODE.................................................................73 Patients on NemoStudio Cloud................................................................................74 Patient Registration.............................................................................................74 Security, Users AND Passwords on NemoStudio Cloud..........................................75 Referrers.................................................................................................................77 Export - Import Patients...........................................................................................78 Export Patients....................................................................................................78 Import Patients.....................................................................................................79 Export Guides.........................................................................................................80 EDIT MENU................................................................................................................82 Image......................................................................................................................83 Capture...................................................................................................................84 Language selection.................................................................................................85 SAVE AND CLOSE NEMOSTUDIO ON DESKTOP OR CLOUD MODE....................86 SAVE AND CLOSE NEMOSTUDIO ON WEB MODE.................................................87 IMAGE CAPTURE......................................................................................................88 2D+ Capture............................................................................................................89 2D+ Capture Desktop (NemoCeph).........................................................................90 SERIES TYPES...................................................................................................97 3D+ Capture..........................................................................................................104 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 3 of 644 STRUCTURE FOR ALL PANELS.............................................................................105 MEASUREMENTS....................................................................................................106 IMPORT DICOM.......................................................................................................107 NEMOSCAN - IMPLANTS PREPARATION..............................................................109 Orientation.............................................................................................................109 Radiographic Index............................................................................................109 Import Models....................................................................................................111 Upper Model Fast Digital Base..........................................................................113 Lower Model Fast Digital Base..........................................................................114 Manual Orientation............................................................................................115 Arches Tracing......................................................................................................117 Describe Arch....................................................................................................117 Nerves/ Sinus....................................................................................................118 Segmentation........................................................................................................121 Teeth to segment...............................................................................................121 Upper Model Segmentation...............................................................................122 Lower Model Segmentation...............................................................................123 Teeth Landmarks...............................................................................................125 Segmenting Teeth Roots...................................................................................126 NEMOSCAN - IMPLANTS RESTORATIONS PLANNING........................................127 EXTRACTIONS.....................................................................................................127 Teeth Extractions...............................................................................................127 Virtual extraction from the bone.........................................................................128 PROSTHESIS.......................................................................................................129 Prosthesis..........................................................................................................129 Hybrid Prosthesis...............................................................................................132 IMPLANTS............................................................................................................133 Treatment Plan..................................................................................................133 Create Reports..................................................................................................140 Treatment Performed.........................................................................................141 ABUTMENT..........................................................................................................143 Planning Information..........................................................................................143 Abutment Design...............................................................................................144 Products................................................................................................................146 Surgical Guide...................................................................................................146 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 4 of 644  Biomodel............................................................................................................153 Biomodel for analogs.........................................................................................154 Build Prosthesis.................................................................................................156 Hybrid Prosthesis...............................................................................................160 Immediate Loading............................................................................................160 NEMOSMILE3D - CASE PREPARATION.................................................................162 Orientation.............................................................................................................162 Import and align the Models...............................................................................162 Manual Orientation............................................................................................164 Orientation Photos.............................................................................................166 Digital Bases.........................................................................................................167 Upper Model Fast Digital Base..........................................................................167 Lower Model Fast Digital Base..........................................................................168 Digital Bases......................................................................................................169 NEMOSMILE3D - CASE PLANNING........................................................................171 EXTRACTIONS WIZARD......................................................................................171 Virtual extraction from the model.......................................................................171 Virtual extraction from the bone.........................................................................172 Prosthesis.............................................................................................................173 Plane with image...................................................................................................176 Overlapping 2D + 3D + 2D guides.........................................................................177 Shells Creation......................................................................................................180 Shells.................................................................................................................180 SMILE EMULATION TOOLS....................................................................................186 Smile Emulations Prep..........................................................................................187 Teeth to segment...............................................................................................187 Upper Model Segmentation...............................................................................188 Lower Model Segmentation...............................................................................189 Teeth Landmarks...............................................................................................190 Segmenting Teeth Roots...................................................................................191 Smile Emulations Setup........................................................................................192 NEMOCAST – PREPARATION OF THE CASE........................................................195 Orientation.............................................................................................................195 Import Models....................................................................................................196 Occlusal Adjustment..........................................................................................197 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 5 of 644  Manual Orientation............................................................................................198 Photos Orientation.............................................................................................200 Digital Bases.........................................................................................................201 Upper Model Fast Digital Base..........................................................................201 Lower Model Fast Digital Base..........................................................................203 Digital Bases......................................................................................................204 Segmentation........................................................................................................205 Teeth to segment...............................................................................................205 Upper Model Segmentation...............................................................................206 Lower Model Segmentation...............................................................................207 Teeth Landmarks...............................................................................................209 Segmenting Teeth Roots...................................................................................210 Tracing and calculation of Wala.........................................................................211 NEMOCAST –PLANNING........................................................................................213 Place incisal guides...............................................................................................213 Manual Setup........................................................................................................216 Extractions in Setup...........................................................................................217 Alignment teeth in Setup....................................................................................217 3D Manual tooth................................................................................................218 2D Manual tooth................................................................................................218 Rotations and Translations................................................................................219 Warnings about movements in Dental Chart......................................................219 Attachments teeth in Setup................................................................................219 Add Bracket.......................................................................................................220 Spacing/Overlaps – IPR.....................................................................................221 Bolton section....................................................................................................222 Occlusion section...............................................................................................222 Create Report....................................................................................................224 Timeline.............................................................................................................226 Mockups................................................................................................................227 Second Phase.......................................................................................................228 Import from Records..........................................................................................229 Import from file...................................................................................................231 Alignment the edited model with a biomodel......................................................231 Products................................................................................................................239 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 6 of 644  Biomodels Setup................................................................................................239 Digital Wax........................................................................................................240 Labeling.............................................................................................................244 Aligners..............................................................................................................246 Export................................................................................................................250 Indirect Bonding Guides.....................................................................................256 Screws Guide....................................................................................................257 Analog model.....................................................................................................260 NEMOCEPH – CASE PREPARATION.....................................................................262 Toolbar..................................................................................................................263 Filters....................................................................................................................269 Transform Images.................................................................................................270 Image Conversion.................................................................................................271 Print Images..........................................................................................................275 Export Images.......................................................................................................275 Open the Image....................................................................................................276 IMAGE MANAGEMENT........................................................................................277 SERIES MANAGEMENT.......................................................................................283 IMAGE SET-UP....................................................................................................294 TEMPLATE MANAGEMENT.................................................................................299 CREATE TEMPLATES..........................................................................................304 TYPES OF TEMPLATES......................................................................................313 NEMOCEPH – CASE PLANNING............................................................................317 CEPHALOMETRIC TRACING...............................................................................317 Tracing Wizard...................................................................................................317 Image Calibration...............................................................................................318 Save and Delete a Cephalometry......................................................................332 TRACING PANEL.................................................................................................334 1. Tracing Wizard...........................................................................................335 2. New Tracing...............................................................................................336 3. Add Lateral Photo / Superimpose Patient Photo.........................................336 4. Superimpose another tracing......................................................................336 5. Import Structures from another Tracing......................................................339 6. X-Ray Rotation...........................................................................................340 VIEW.....................................................................................................................341 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 7 of 644  Analysis.............................................................................................................341 Analysis Settings...............................................................................................344 Display Layers...................................................................................................344 Profile................................................................................................................347 Control Points....................................................................................................347 Areas.................................................................................................................347 Vert....................................................................................................................348 Anchorage.........................................................................................................348 Measurements...................................................................................................349 PRINTING.............................................................................................................353 PREDICTIONS (TREATMENT PLANS)................................................................357 Predictions.........................................................................................................357 FRONTAL ANALYSIS...........................................................................................383 Cephalometric Tracing.......................................................................................383 Calibration: Calibrate the image.........................................................................384 MODEL ANALYSIS...............................................................................................388 Occlusogram Tracing.........................................................................................388 Model Measurements........................................................................................393 Bolton & Moyers Indexes...................................................................................394 Bolton Indexes...................................................................................................396 NEMOFAB - ORTHO/ORTHOGNATHIC VOLUME PREPARATION........................397 Orientation.............................................................................................................398 Import and align the Models...............................................................................398 Automatic Orientation........................................................................................399 Manual Orientation............................................................................................401 Photos Orientation.............................................................................................403 Records.................................................................................................................404 3D Photo mapping.............................................................................................404 Import 3D Photo (OBJ)......................................................................................405 Build X-Rays......................................................................................................406 Dental Nerves....................................................................................................407 TMJ...................................................................................................................408 Airway................................................................................................................409 Import Lateral Photo..........................................................................................410 Segmentation........................................................................................................412 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 8 of 644  Upper model merge area...................................................................................412 Lower model merge area...................................................................................414 Merge models to volume....................................................................................415 Osteotomies..........................................................................................................417 Import segmented models.................................................................................420 Chin Osteotomy.................................................................................................421 3D Ceph................................................................................................................421 NEMOFAB - ORTHOGNATHIC SURGERY ANALYSIS AND PLANNING................424 2D Ceph................................................................................................................424 3D Treatment Plan................................................................................................425 Standard Planning.............................................................................................425 Arnett Classic Wizard.........................................................................................427 Arnett Classic Wizard Mx...................................................................................433 Remove active surgical treatment plan..............................................................433 Create Reports..................................................................................................433 Guides...................................................................................................................434 Splints Design....................................................................................................434 Build Pre-Surgical Splints..................................................................................439 Reshaping Guides.............................................................................................441 Plates Design....................................................................................................442 Osteotomy Guide...............................................................................................451 OTHER TOOLS FOR PLANNING.............................................................................453 Compare Pre and Post CBCT...............................................................................453 Surgical Boxes and Sleeves..................................................................................454 Insert Screws........................................................................................................459 Design Wires.........................................................................................................464 Blocked Model.......................................................................................................466 Connectors............................................................................................................468 Baseplates............................................................................................................470 Occlusal Splints.....................................................................................................476 Virtual Pour Up......................................................................................................477 Model Builder........................................................................................................479 Align 3D with Photos.............................................................................................482 Import 3D Mesh (OBJ)..........................................................................................485 Morphing...............................................................................................................486 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 9 of 644  Lips Morphing........................................................................................................488 Gingivectomy guide...............................................................................................491 Preparation Guide.................................................................................................491 Expansion Plate....................................................................................................493 Corticotomy Guide.................................................................................................497 Import X-Ray.........................................................................................................502 NEMOSTORIES.......................................................................................................505 VIRTUAL ARTICULATOR.........................................................................................508 Virtual articulator...................................................................................................509 Virtual Articulator in Treatment Plan......................................................................515 Lower arch autorotation – incisal pin opening........................................................517 Apply a relationship to meshes associated to lower arch.......................................518 Import models with a relationship..........................................................................519 Build a bite splint...................................................................................................521 Functional or surgery simulation moving lower model...........................................528 Jaw tracker............................................................................................................530 Hinge Axis Locator................................................................................................535 Jaw Animation.......................................................................................................537 BASIC NEMOSTUDIO CONCEPTS.........................................................................538 ADVANCED CONCEPTS IN NEMOSTUDIO............................................................568 Mesh Transformation............................................................................................569 Mesh Operations...................................................................................................569 Add label in mesh..................................................................................................570 Compare meshes..................................................................................................570 Mesh alignment.....................................................................................................570 Align mesh with CBCT..........................................................................................570 NEMOSTUDIO WEB VERSION................................................................................577 Auto segmentation................................................................................................577 Options to edit Photos...........................................................................................579 Photos...............................................................................................................580 Compare............................................................................................................580 Calibrate............................................................................................................580 Transforms........................................................................................................581 Processing.........................................................................................................583 Filters.................................................................................................................583 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 10 of 644  Magnifying glass with filters...............................................................................584 Annotations........................................................................................................585 Masks................................................................................................................586 Densitometry.....................................................................................................588 Changes............................................................................................................589 Lateral Options......................................................................................................591 Anatomy............................................................................................................591 Mesh..................................................................................................................592 Objects..............................................................................................................592 Ceph Objects.....................................................................................................593 Analysis 2D........................................................................................................594 Implants Restorations Treatment Plan...................................................................594 NemoScan Toolbar...............................................................................................596 Tracker 3D.........................................................................................................596 Describe Arch....................................................................................................597 Photos...............................................................................................................598 Measure.............................................................................................................599 Guides...............................................................................................................599 Layouts..............................................................................................................600 View...................................................................................................................601 NemoCast Toolbar................................................................................................601 Tracker 3D.........................................................................................................601 Attach................................................................................................................602 Staging..............................................................................................................603 IPR....................................................................................................................605 Movements........................................................................................................606 Contacts............................................................................................................606 Bolton................................................................................................................607 Photos...............................................................................................................607 Measure.............................................................................................................609 Guides...............................................................................................................610 Layouts..............................................................................................................611 View...................................................................................................................611 Analysis.............................................................................................................612 Report................................................................................................................612 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 11 of 644  NemoFAB Toolbar.................................................................................................613 Tracker..............................................................................................................613 Photos...............................................................................................................613 Measure.............................................................................................................614 Guides...............................................................................................................614 Layouts..............................................................................................................614 View...................................................................................................................615 Analysis.............................................................................................................616 Report................................................................................................................617 Orthognathic Surgery Planning..............................................................................619 IMPORT LIBRARIES................................................................................................623 Import Predesigned Objects..................................................................................623 Import Implants, Pins, Abutment and Guides.........................................................624 Import Analysis......................................................................................................625 Import Brackets.....................................................................................................626 NEMOSTUDIO - FREQUENTLY ASKED QUESTIONS (FAQ).................................628 NEMOSCAN - FREQUENTLY ASKED QUESTIONS...............................................630 NEMOSMILE - FREQUENTLY ASKED QUESTIONS (FAQ)....................................634 NEMOCAST – FREQUENTLY ASKED QUESTIONS (FAQ)....................................636 NEMOCEPH - FREQUENTLY ASKED QUESTIONS (FAQ).....................................639 NEMOFAB - FREQUENTLY ASKED QUESTIONS (FAQ)........................................642 LEGEND OF LABELS AND SYMBOLS....................................................................643 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 12 of 644 INTRODUCTION NemoStudio is Nemotec’s digital interdisciplinary platform for dentistry that allows import/capture, storage, analysis, treatment plan and presenting/reporting of all those patients and their records, a worldwide reference in the field of Dentistry. NemoStudio has as its main objective to coordinate and unify all Nemotec applications, making them all compatible with each other and allowing an easier use of the software package that makes up the Nemotec software suite. This software suite presents its clients with unique, multidisciplinary and state-of-the-art solutions for the dental sector, compatible with any hardware on the market. It adds a multidisciplinary value to the work of doctors and it is recognized by international opinion leaders specialized in each area of Dentistry: Orthodontics, Orthognathics, Implantology and Aesthetics. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 13 of 644 NemoStudio Advantages A unique digital platform to work on, upload, edit and communicate patient cases: multi-disciplinary coordination and management. Greater predictability and clinical efficiency - all doctors examine the same case from their different specialties. Saves time - the NemoStudio Suite 2024 includes all cases and patient records in a single digital platform with a single interface. Greater control and quality with a practical and modern approach based on cutting-edge technology. An increase and higher acceptance of patient cases in the clinic. The improvement of communication between doctors and the laboratories of different specialties with a 100% digital flow. NemoStudio offers a complete pack of modules for the dental industry which can be added according to the customer’s needs and desired features. Each module is adapted to a different field of service, as follows: ➔ NemoCast - Software for Orthodontic planning ➔ NemoCeph – Cephalometric Software ➔ NemoFAB - Software for Orthognathic surgery ➔ NemoScan - Software for Implantology planning ➔ NemoSmile - Software for Digital Smile Design, Smile Emulations and Shell Designer 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 14 of 644 Since every module has its own capabilities, in the following sections a description of each one will be provided. NemoCast NemoCast is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact. NemoCast allows the user to: Import, organize, store images from CT or CBCT in DICOM format (optionally if the case has these images, called Volume Images). Import digital impressions of the teeth (scanned stone models and intraoral scanner) in STL, PLY or OBJ format, and align them over the volume image (if exists). Reorient the 3D volume. Do crowns and gingival segmentation on the digital models. Do root segmentation and complete teeth fusion (in case of volume image exists). If no volume image exists, it is possible to have virtual roots based on 3D templates for each tooth root. Do teeth landmarks identification in order to generate models analysis measurements. Do setups (treatment plans) doing individual movements of the teeth. Do staging of the different teeth movements. Export to STL the 3D models of the different stages of the setup. Export indirect bonding guide for Brackets placement. Inspect and analyze the progress of the treatment. Inspect and analyze the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. Results produced by the software and treatment plan tools are dependent on the quality of the records and the interpretation of trained and licensed practitioners. 3D manufacturing is out of NemoCast software control, depends on many external factors and lies within the sole responsibility of the user. Caution The provided instructions contain important information on the safe and appropriate use of the software. Make sure to have read and understood this document prior to installing and operating the software. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 15 of 644 Disclaimer NemoCast software is intended for use by dental professionals who have appropriate medical knowledge and training in orthodontic and dentistry. To run the software, users must also have basic skills in managing computers. The user of NemoCast is solely responsible for determining whether any product or treatment is suitable for a particular patient and circumstances. The user of NemoCast is solely responsible for the correctness, completeness and adequacy of all data entered in NemoCast software. The user must check the correctness and accuracy of planning with NemoCast software and to assess each individual case. Nemotec products must be used in accordance with their accompanying instructions for use. Improper use or handling of Nemotec products will void the warranty, if any, given for Nemotec products. If you require additional information on the proper use of Nemotec products, contact your local distributor. The user is not allowed to modify Nemotec products. Updates to hardware and software components are made regularly. Therefore, some of the instructions, specifications and pictures contained in these Instructions for Use may differ slightly from your situation. Nemotec reserves the right to revise or make changes or improvements to this product or documentation at any time without obligation to notify any person of such revisions or improvements. The user is obliged to study the latest developments of NemoCast regularly. Input data The performance of NemoCast depends on the quality and accuracy of the CBCT or 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 NemoCast. Relevant anatomical structures must be visible in the above scans. CBCT or CT devices have to comply with the recommendations of ICRP97 (International Commission on Radiological Protection). Third party products and product data When planning patient cases with NemoCast and during the practical implementation of such planning the user may work with third party products and/or product data. Nemotec, its subsidiaries, or distribution partners disclaim any liability for damages in connection with or arising from such third-party product data or products being used within this scope. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 16 of 644 License, trademarks and other rights NemoStudio License NemoStudio 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 NemoStudio software on any medium except those permitted in the License Agreement. Some of the modules offered by NemoStudio may require an additional 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 NEMOTEC and/or other trademarks and registered trademarks from Nemotec mentioned herein are the trademarks or registered trademarks of Nemotec. All other trademarks are the property of their respective owners. Copyright Nemotec documents may not be reprinted or published, in whole or in part, without the written authorization of Nemotec. Indications for use NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient’s dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/ desired treatment objectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment. The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 17 of 644 Contraindications None identified for NemoCast. It is the user's responsibility to evaluate whether any decisions regarding specific treatment plans can be made in the clinic during treatment. Warnings ⚫ ATTENTION: U.S. federal law restricts this product to sale by or on the order of a licensed dentist or physician. ⚫ NemoCast software works exclusively with axial tomographic slices in DICOM 3.0 format. ⚫ 3D segmentations of anatomies must be compared with the slice images and verified for approval by the responsible clinician. ⚫ For scans taken with an inter-slice distance of 1 mm the accuracy of the 3D reconstructions in the software varies between 0.1 and 0.2 mm. The use of larger inter-slice distances is not recommended. ⚫ Make sure to validate the teeth movements planned and be sure that those movements are clinically and anatomically viable in real life, the software does not check if the movements are appropriate to be performed in a real life situation" and the user has to have clinical knowledge to evaluate the treatment plan. ⚫ Model importation:  Ensure that any model scans imported into the system represent the patient-specific dentition of adequate quality.  Alignment process: Please verify that the alignment is correct using the 2D slices. Manual alignment is available. ⚫ Manual tooth segmentation:  Make sure to validate the spacing limits and tooth axes sufficiently when segmenting teeth with available visual inspection tools, in particular DICOM overlay or 2D radiograph images. ⚫ Some tools and functions use colors to guide and evaluate the design. Therefore, to use them efficiently, you must have the ability to recognize colors. ⚫ Anatomical points  Make sure to validate that the anatomical points placed over the crowns are in their correct position, in particular that all of them are present. ⚫ Performing analysis  Make sure to place the analysis points on the 3D model correctly according to the analysis protocol by optimizing zoom and position visualization to measure the correct anatomical features. ⚫ Collision detection  Use the available tools for collision detection and distance mapping during the virtual setup process. ⚫ Transparent aligners  To avoid confusion of aligners sequenced by patients, aligners can be marked with id labels. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 18 of 644  ⚫ Measurements  Make sure to place measurement points on the 3D model and 2D cross- section carefully by optimizing zoom and position visualization to measure the correct anatomical features.  All software measurements are displayed in mm and degrees.  Accurate measurements must be performed on the slice images (2D). The quality of the images and 3D surface models in the NemoCast software depends on the quality of the records used. ⚫ Product manufacturing:  It is the responsibility of the appliance manufacturer to ensure that the equipment and materials used are suitable for the production of appliances for orthodontic purposes. Nemotec does not manufacture or sell quick milling/prototyping machines and cannot therefore be held responsible for the results of a custom production process where NemoCast software is used as a component.  Please ensure that the required material thickness and setting parameters are applied, when creating the fixture model - according to the specific material and manufacturing machine requirements to be used.  It is the responsibility of the appliance manufacturer to ensure that the 3D appliance design is suitable for orthodontic purposes.  Note! The physical results you may produce using the Nemotec software may be considered a medical device in your territory. You are responsible for checking with your local regulatory agency for legal requirements related to the manufacture of these products. ⚫ Products shown in the Software may not have regulatory clearance for all countries, and it’s the responsibility of the professionals to check the availability of the products in its region. Precautions The provided instructions contain important information on the safe and appropriate use of the software. Make sure to have read and understood this document prior to installing and operating the software. NemoCAST software is designed as advanced medical software to be used by individuals with the necessary medical knowledge and training in orthodontics and dentistry to perform digital orthodontic workflows that do not influence or contradict conventional clinical treatment concepts and treatment principles. Be sure to use dental alloys or resins cleared or listed by the FDA for appliance fabrication. The FDA considers physical outputs to be medical devices regulated under 21 CFR 872.5470 that have regulatory requirements such as 510(k) clearance, registration and listing, equipment/manufacturing process validation, and quality system regulations. 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. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 19 of 644 The NemoCast software cannot determine in any way whether a specific tooth movement or whether a combination of tooth movements visualized in the software can be concretely implemented on a patient in real life. The software also does not contain a function to check whether such real-life implementations could produce damage, for example to the patient's teeth or gums. Any treatment that attempts to implement tooth movement or other manipulations visualized with the software on a patient should be planned and carried out only by a practitioner who has assessed with the necessary diligence whether the manipulation visualized can actually be implemented without causing harm to the patient. It is advisable to use the guide or model within a not extended time from the completion of the CT/MR scans on which they are based, taking into account possible physiological variations that may occur. The user must have sufficient experience in the use and handling of Windows™ based software. Including the Windows™ operating system itself. Before you can use the software in clinical cases, make sure you have received adequate training and instructions on how to operate the software correctly. If specific or advanced training is required, please contact your responsible sales representative/distributor. Nemotec is not responsible for the security of the end user's data or for any failure of the computer system that may result in loss of data. The user's organization is responsible for protecting the computer and network using up-to-date virus and malware protection software and a firewall. Nemotec disclaims any and all liability, express or implied, and shall have no liability for any direct, indirect, punitive or other conclusion or damage arising out of or in connection with any error of judgment or professional practice in the use of Nemotec products. Since the use of this product is under the control of the user, it is the responsibility of the user. Nemotec assumes no liability for any damages arising therefrom. Caution Patients' dental anatomy is subject to change. It is the user's responsibility to adhere to good dental practice in respect of time delays between data collection and treatment planning. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 20 of 644 NemoCeph NemoCeph is a software that allows its users to generate cephalometric analysis and perform a study with cephalometric tracing for a complete analysis in orthodontic treatment. The main functions of NemoCeph software are: ✔ Performing cephalometry by standard analysis. ✔ Customization of cephalometric analysis (only tracing, on the radiograph or on the photograph). ✔ Superimposition of photographs on cephalometry. ✔ Prediction on soft tissue (morphing). ✔ Creation of orthodontic treatment plans (VTO, STO and morphing). ✔ Creation of orthodontic and orthognathic surgery treatment plans (Dr. Arnett's module) in 2D. ✔ Generation of patient communication templates and customized reports. Indications for use NemoCeph is a software indicated to perform cephalometric tracings for a complete analysis of the morphology, physiology, and craniofacial pathology to be used to individualize and thoroughly plan the orthodontic treatment. It is used to generate tracing reports and make predictions about the patient's soft tissue. Precautions NemoCeph software is designed as a medical software to be used by people with knowledge and training in dentistry. Any analysis attempted on a patient with the NemoCeph software should only be performed by a professional who has diligently assessed whether the visualized analysis can be used for planning without causing harm to the patient. The user must have sufficient experience in the use and operation of Windows™-based software. Including the Windows™ operating system itself Before you can use the software in clinical cases, make sure you have received proper training and instructions on how to operate the software correctly. If specific or advanced training is required, end users should ask their responsible salesperson/distributor to contact to arrange this training. Nemotec is not responsible for the security of end user data or for any computer system failure that may result in data loss. The user's organization should be responsible for protecting the computer and network by using up-to-date virus and malware protection software and a firewall. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 21 of 644 Nemotec disclaims any and all liability, express or implied, and shall have no liability for any direct, indirect, punitive or other conclusion or damage arising out of or in connection with any error of judgment or professional practice in the use of Nemotec products. Since the use of this product is under the control of the user, it is the responsibility of the user. Nemotec assumes no liability for any damages arising therefrom. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 22 of 644 NemoFAB and NemoFAB Ortho The NemoFAB software is a tool designed for use by specialized dental or orthognathic practices or maxillofacial practices and surgeons for importing, storing and presenting patient images and supporting the orthognathic process and virtual treatment planning in Orthognathic and Maxillofacial Surgery procedures. Additionally NemoFAB can process the medical images to design various patient-specific digital outputs which include custom plates (implants), anatomical models, guides, splints, bone grafts meshes and case reports. NemoFAB allows the user to import the digital dental impressions in STL format (from a laboratory scanner or intraoral scanner) and merge them to the CT of the patient; this process is necessary if a splint is going to be created. The TMJ and airways of the patient can be segmented from the CT/CBCT to do measurements and analysis. Several types of osteotomies are supported: All kinds of Maxillary Le Fort, Bisagittal split, Chin and also Segmented Chin, Maxilla or Mandible in a diverse number of pieces too. The Arnett 3D cephalometric tracing allows the surgeon to have accurate measurements information about the position of the anatomical structures and the extent of the movements; ceph tracing allows the user to digitize anatomical landmarks on a patient’s Volume (in 3D) or radiograph (in 2D). Arnett FAB Cephalometric Analysis performs face, airway and bite analysis, and allows to simulate a treatment plan for orthodontic and surgical cases based on the methodologies of Dr. William Arnett. If the user does not want to follow the protocol of Dr. Arnett, a manual treatment plan can be done. The planning of the predicted final positions after surgery allows this module to create splints for aiding the surgeon in the placement of the bones in the surgery according to the treatment plan. Those splints can be produced in 3D printers or milling machines. For this purpose, the module is able to: Import, organize, store images from CT or CBCT in DICOM format (optionally if the case has these images, called Volume Images). Import digital impressions of the teeth (scanned stone models and intraoral scanner) in STL or PLY format, and align them over the volume image (if exists). Import facial scanner or 3D photos in OBJ or PLY format. Measurements of distances and angles in 2D, for slices, and 3D, for 3D views. Merge the dental digital impressions into the CT/CBCT patient volume. Do Orientation of the Volume according to the Natural Head Position of the patient (Reorient the 3D volume) Process and present the images (it can generate virtual frontal, lateral and panoramic x-rays). Take measurements in the 2D and the 3D images. Segmentation of Skull, Mandible, Face, Airways, Dental Nerves, Sinus and any manual volume region of anatomy or pathology. Airways analysis. Do evaluation of the airways volume and valve area. TMJ analysis. Reformat the coronal and sagittal slices of the TMJ area. Generate virtual XRays from different projections as lateral, frontal or panoramic. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 23 of 644  Perform 3D Photos using external 3D Photo or mapping 2D Photos over the 3D Skin extracted from the Volume. Perform osteotomies as all kinds of Maxillary Le Fort, Bisagittal split, Chin and also Segmented Chin, Maxilla or Mandible in a diverse number of pieces too or any custom anatomy design. Perform a 3D cephalometric analysis based on the methodologies of Dr. Willian Arnett. Perform a 2D cephalometric analysis based on the methodologies of Dr. Willian Arnett. Evaluate analysis measurements. Perform the virtual orthognathic surgery treatment plan in a generic way or according to Dr. Arnett’s protocol on the 2D and 3D. Design the surgery splints according to the treatment plan. Design the intermediate and final splints. Design the osteotomy guides. Design cutting bone guides. Design the patient individualized plating system. Possibility of simulation of virtual bone grafts with, included in the software, tools for adding/removing/sculpting material in a way similar to waxing manual methods. Design of meshes covering bone grafts. Make reports of the virtual orthognathic treatment plan. All working steps are saved to the patient file; one patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. The guided surgical template plan, STL file and/or guided surgical protocol is generated from the final surgical plan. The device has no patient contact. nor does it control any life-sustaining devices. 3D manufacturing is out of NemoFAB software control, depends on many external factors and lies within the sole responsibility of the user. As for the design and construction requirements: The development of the system has been done in Visual C ++ for windows cloud and desktop. The development of the system has been done in JAVA for web version. The tool used for reporting is JIRA. The database management system is Microsoft Access. NemoFAB Ortho is a subversion of NemoFAB software including only a few modules: Import and analysis of 2D (photographs and radiographs) and 3D (3D files and Computed Tomography DICOM format) records. Volume orientation Alignment of 3D files with the DICOM volume. Cephalometric analysis Mandibular reshaping (only with its license active) Splints and guides export in.stl format (only with plan Smart) 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 24 of 644 Indications for use NemoFAB is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the NemoFAB and the result is an output data file in STL that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, bone grafts meshes and case reports for use in maxillofacial, midface, & mandibular surgery. NemoFAB orthognathic devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age to < 12 years of age), adolescents (12 years of age - 21 years of age), and adults. NemoFAB software allows for surgical implants, anatomical models, guides and splints to be exported to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). Implants, anatomical models, guides and splints may require to be used with accessories. Warnings ⚫ ATTENTION: U.S. federal law restricts this product to sale by or on the order of a licensed dentist or physician. ⚫ NemoFAB software works exclusively with axial tomographic slices in DICOM 3.0 format. ⚫ 3D segmentations of anatomies must be compared with the slice images and verified for approval by the responsible clinician. ⚫ For scans taken with an inter-slice distance of 1 mm the accuracy of the 3D reconstructions in the software varies between 0.1 and 0.2 mm. The use of larger inter-slice distances is not recommended. ⚫ Model importation:  Ensure that any model scans imported into the system represent the patient-specific dentition of adequate quality.  Alignment process: Please verify that the alignment is correct using the 2D slices. Manual alignment is available. ⚫ Some tools and functions use colors to guide and evaluate the design. Therefore, to use them efficiently, you must have the ability to recognize colors. ⚫ Measurements  Make sure to place measurement points on the 3D model and 2D cross- section carefully by optimizing zoom and position visualization to measure the correct anatomical features.  All software measurements are displayed in mm and degrees. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 25 of 644   Accurate measurements must be performed on the slice images (2D). The quality of the images and 3D surface models in the NemoFAB software depends on the quality of the records used. ⚫ Product manufacturing:  It is the responsibility of the appliance manufacturer to ensure that the equipment and materials used are suitable for the production of appliances for orthodontic purposes. Nemotec does not manufacture or sell quick milling/prototyping machines and cannot therefore be held responsible for the results of a custom production process where NemoStudio software is used as a component.  Make sure that the default parameters for the calculation of the element to be manufactured are compatible with your manufacturing device and the materials used for an accurate construction.  Note! The physical results you may produce using the Nemotec software may be considered a medical device in your territory. You are responsible for checking with your local regulatory agency for legal requirements related to the manufacture of these products.  The guide must be fabricated based on the FDA cleared or legally marketed 3D printing fabrication method. The STL is to be exported to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable).  Note! In the US, the physical surgical guide for endosseous dental implant placement are medical devices. Please contact a third-party medical device manufacturer registered and listed in compliance with FDA regulatory requirements to manufacture the physical surgical guide for endosseous dental implant placement or to purchase a legally marketed, validated milling/printing system to create the physical implant surgical guide and at an on-site location. For more information, please contact your local regulatory agency for information regarding the regulatory status and requirements related to manufacture of these implant surgical guides. ⚫ The generated surgical guide files are only valid for the planned surgical procedure. ⚫ Please note that locally produced surgical guides must be manufactured using validated processes and appropriate materials in accordance with the manufacturer's instructions for use. The optimal fit must be verified prior to the surgical procedure. ⚫ We recommend that the clinician use FDA-approved materials and equipment indicated for the fabrication of dental splints. ⚫ Products shown in the Software may not have regulatory clearance for all countries, and it’s the responsibility of the professionals to check the availability of the products in its region. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 26 of 644 Precautions The NemoFAB software is designed as an advanced medical software to be used by individuals with the necessary medical knowledge and training in maxillofacial surgery and dentistry. It is designed for use as a preoperative software program for simulation and evaluation of orthognathic surgical treatment options. The FDA considers physical outputs to be medical devices regulated under 21 CFR 872.2050 that have regulatory requirements such as 510(k) clearance, registration and listing, equipment/manufacturing process validation, and quality system regulations. The user must have sufficient experience in the use and operation of Windows™-based software. Including the Windows™ operating system itself Any treatment that is intended to be applied to a patient, visualized with the NemoFAB software, should be planned and carried out only by a professional who has evaluated with the necessary diligence whether the visualized manipulation can really be implemented without causing harm to the patient. Before you can use the software in clinical cases, make sure you have received proper training and instructions on how to operate the software correctly. If specific or advanced training is required, end users should ask their responsible salesperson/distributor to contact to arrange this training. It is advisable to use the guide or model within a not extended time from the completion of the CT/MR scans on which they are based, considering possible physiological variations that may occur. Nemotec is not responsible for the security of end user data or for any computer system failure that may result in data loss. The user's organization should be responsible for protecting the computer and network by using up-to-date virus and malware protection software and a firewall. Nemotec disclaims any and all liability, express or implied, and shall have no liability for any direct, indirect, punitive or other conclusion or damage arising out of or in connection with any error of judgment or professional practice in the use of Nemotec products. Since the use of this product is under the control of the user, it is the responsibility of the user. Nemotec assumes no liability for any damages arising therefrom. Treatment Steps 1. Volume Orientation. The orientation of the volume is automatically achieved with the introduction of clinically significant measurements. The facial midlines, levels, and yaw are used to orient the volume. 2. Records Production. During this process the panorex, headfilms, tomograms, and airway records are automatically and simply produced. 3. Segmentation. In this step, the CBCT and models are rapidly and automatically merged as one, to allow analysis and treatment planning to follow. This step is not required in orthodontic analysis and treatment planning. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 27 of 644  4. Osteotomy Design. The surgeon designs the osteotomies to reflect exactly his or her preference for anatomical design. The customization of the osteotomies produces a preview of what will be evaluated in the operating room. 5. 3D Cephalometric Analysis. This step allows precision identification and digitization of important landmarks in the 3D environment. Key landmarks are selected which lead to consistent and superior results. 6. CephalometricTreatment Planning. Soft tissue cephalometric treatment planning is utilized to analysis problems of the face in the profile view. Cephalometric treatment planning is then utilized to correct issues that have been identified. 7. 3D Dimensional Treatment. The frontal midline, cant, and yaw corrections are automatically imported from step 1 orientation. The profile corrections achieved in step 6 (cephalometric treatment planning) are imported to correct the anteroposterior, vertical, and occlusal plane deformities. Step 7 corrects the face, airway, and bite in 3 dimensions. 8. Splint Design. In the final step, the doctor is able to design the splint to his or her specifications. The splint can then be made wherever is convenient for the doctor's schedule. NemoFAB Software Benefits ⚫ The NemoFAB software allows flexible usage: no set timing nor scheduling dictated by outside service centers. The treatment is done totally on the doctors schedule. ⚫ Accurate volume orientation of the CBCT based on the clinical patient. ⚫ Generation of all records: panorex, tomograms, cephalometric films, and airway analysis. ⚫ The entire treatment process in one place allows for total doctor control. ⚫ Osteotomy design by the doctor to the doctors specifications. ⚫ Cephalometric analysis according to the methods of Arnett's soft tissue cephalometric analysis and 7 step cephalometric treatment planning. Traditional cranial base cephalometrics available when desired. ⚫ Accurate 3D treatment planning. Clinical data is produced for accurate frontal and profile treatment guided by proven protocols. ⚫ Analysis and Treatment planning based on Arnett's methods and protocols. ⚫ NemoFAB software allows the doctor to do as little or as much of the treatment process as desired with technical support as needed. ⚫ NemoFAB enables model block to software conversion. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 28 of 644  ⚫ All records stored in the image library including 2D and 3D imaging, photographs, examination forms, 2D/3D treatment, and more. Every record in one place for organized treatment and review. ⚫ Orthognathic Surgery and Orthodontic versions available. ⚫ An additional benefit of the NemoFAB software is integration with other Nemotec software modules. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 29 of 644 NemoScan NemoScan is a comprehensive analysis and treatment planning software for dental implantology intended to be used by dental professionals who have appropriate knowledge in surgical implantology and dental implants prosthesis. The software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. The software is provided in three configurations: desktop, cloud and web. Surgical planning is performed through convenient layouts of views, analysis of image data and the placement of virtual dental implants and optionally virtual prosthetic teeth. One patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. Additional functions are available to the user for refinement of the surgical planning, such as: Import, organize, store images from CT or CBCT in DICOM format (optionally if the case has these images, called Volume Images). Import digital impressions of the teeth (scanned stone models and intraoral scanner) and/or implant files in STL or PLY format, and align them over the volume image (if exists). Import facial scanner or 3D photos in OBJ or PLY format. Measurements of distances and angles in 2D, for slices, and 3D, for 3D views. Patient gums, teeth, bones, mandibular nerves and sinus segmentation to help the planner in viewing those anatomical conditions in 3D and their corresponding cross sections in the 2D slices. Possibility of simulation of teeth extractions for immediate implants placement. Specific layouts of views with the selected implant centered to accurately positioning the virtual implant according to the anatomical volume conditions. Bone densitometry with a density statistic for density measuring in the area around a distance outside and inside the limits of the positioned implant. Real time distances and angles to sensible areas like other implants, nerves, patient teeth, sinus, etc. Possibility of adding prosthetic teeth for designing the immediate loading prosthesis or just for helping in orienting the implants according to the prosthetic conditions. NemoScan works with many manufacturers of implants, abutments, drills, analog, sleeves, hand pieces, etc., libraries to be used for simulation and treatment planning. The software allows importing these libraries and designing different kinds of surgical guides and immediate loading prosthesis to export the designed file in STL format. Finally, these designed files will be used to a validated manufacturing center or to the point of care. The device has no patient contact nor does it control any life-sustaining devices. Warning: Anatomical segmented structures cannot be used as sole information for the clinician to make clinical decisions. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 30 of 644 3D manufacturing is out of NemoScan software control, depends on many external factors and lies within the sole responsibility of the user. Warning: The guide must be fabricated based on the FDA cleared or legally marketed 3D printing fabrication method. The STL is to be exported to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). Caution The provided instructions contain important information on the safe and appropriate use of the software. Make sure to have read and understood this document prior to installing and operating the software. Disclaimer NemoScan software is intended for use by dental professionals who have appropriate medical knowledge and training in implantology and dentistry. To run the software, users must also have basic skills in operating a computer. The user of NemoScan is solely responsible for determining whether or not any product or treatment is suitable for a particular patient and circumstances. The user of NemoScan is solely responsible for the correctness, completeness and adequacy of all data entered into NemoScan software. The user must check the correctness and accuracy of planning with NemoScan software and to assess each individual case. Correct dimensioning of the surgical guide, the selection of appropriate material and an appropriate and calibrated 3D manufacturing system as well as the correct fabrication of scan templates and surgical guides lie within the sole responsibility of the user. Nemotec products must be used in accordance with their accompanying instructions for use. Improper use or handling of Nemotec products will void the warranty, if any, given for Nemotec products. If you require additional information on the proper use of Nemotec products, contact your local distributor. The user is not allowed to modify Nemotec products. Updates to hardware and software components are made regularly. Therefore, some of the instructions, specifications and pictures contained in these Instructions for Use may differ slightly from your particular situation. Nemotec reserves the right to revise or make changes or improvements to this product or documentation at any time without obligation to notify any person of such revisions or improvements. The user is obliged to study the latest developments of NemoScan regularly. Input data The performance of NemoScan depends on the quality and accuracy of the CBCT or 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 NemoScan. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 31 of 644 Relevant anatomical structures must be visible in the above scans. CBCT or CT devices must comply with the recommendations of ICRP97 (International Commission on Radiological Protection). Third party products and product data When planning patient cases with NemoScan and during the practical implementation of such planning the user may work with third party products and/or product data. Nemotec, its subsidiaries, or distribution partners disclaim any liability for damages in connection with or arising from such third-party product data or products being used within this scope. License, trademarks and other rights NemoScan License NemoScan 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 NemoScan software on any medium except those permitted in the License Agreement. Some of the modules offered by NemoScan may require an additional 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 NEMOTEC and/or other trademarks and registered trademarks from Nemotec mentioned herein are the trademarks or registered trademarks of Nemotec. All other trademarks are the property of their respective owners. Copyright Nemotec documents may not be reprinted or published, in whole or in part, without the written authorization of Nemotec. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 32 of 644 Indications for use NemoScan is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scanners such as CBCT or CT scanners. It is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous, partial edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step. NemoScan software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories. Contraindications None identified for NemoScan. It is the user's responsibility to evaluate whether any decisions regarding specific treatment plans can be made in the clinic during treatment. Any treatment that is intended to be applied to a patient, visualized with the NemoScan software, should be planned and carried out only by a professional who has evaluated with the necessary diligence whether the visualized manipulation can really be implemented without causing harm to the patient. Warnings ⚫ ATTENTION: U.S. federal law restricts this product to sale by or on the order of a licensed dentist or physician. ⚫ Customers must be sure that in the country that will be using this medical device it’s regulated. NemoScan it’s a medical device as a module of NemoStudio with CE certificate. NemoScan has 510 (k) certificates in the USA. ⚫ NemoScan is also FDA approved in Thailand. ⚫ NemoScan software works exclusively with axial tomographic slices in DICOM 3.0 format. ⚫ 3D segmentations of anatomies must be compared with the slice images and verified for approval by the responsible clinician. ⚫ For scans taken with an inter-slice distance of 1 mm the accuracy of the 3D reconstructions in the software varies between 0.1 and 0.2 mm. The use of larger inter-slice distances is not recommended. ⚫ Model importation:  Ensure that any model scans imported into the system represent the patient-specific dentition of adequate quality. 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 33 of 644   Alignment process: Please verify that the alignment is correct using the 2D slices. Manual alignment is available. ⚫ Manual tooth segmentation:  Make sure to validate the spacing limits and tooth axes sufficiently when segmenting teeth with available visual inspection tools, in particular DICOM overlay or 2D radiograph images. ⚫ Some tools and functions use colors to guide and evaluate the design. Therefore, to use them efficiently, you must have the ability to recognize colors. ⚫ Anatomical points  Make sure to validate that the anatomical points placed over the crowns are in their correct position, in particular that all of them are present. ⚫ Performing analysis  Make sure to place the analysis points on the 3D model correctly according to the analysis protocol by optimizing zoom and position visualization to measure the correct anatomical features. ⚫ Collision detection  Use the available tools for collision detection and distance mapping during the virtual setup process. ⚫ Measurements  Make sure to place measurement points on the 3D model and 2D cross- section carefully by optimizing zoom and position visualization to measure the correct anatomical features.  All software measurements are displayed in mm and degrees.  Accurate measurements must be performed on the slice images (2D). The quality of the images and 3D surface models in the NemoScan software depends on the quality of the records used. ⚫ Prosthesis design:  To obtain a healthy functioning restoration, make sure that the emergence profile of your restoration is optimally delineated and contoured, and make sure that it includes all areas required for the restorative design.  A licensed dentist should inspect for proper fit and under static and dynamic tooth movements of the dental restoration produced to ensure the health of the patient.  In cases of post-surgical definitive prosthetic design, in order to obtain a healthy functioning restoration, it is critical to accurately detect the position and orientation of the implant. Therefore, ensure that the correct alignment of an implant scan abutment and its library model are achieved for each restoration. ⚫ Implant treatment planning:  The software allows users to visualize a safety area around the implant whose extension can be modified by the user. Be careful if you decide to modify the default values.  Always check the drill length associated with the length of the drills. The system shows a message "Invalid drilling".  The guided surgery planning configuration can be controlled by the user, using precaution when setting all the surgery parameters. The system 28/05/2024 NemoStudio – User Guide Ed.24.3 EN 34 of 644  shows a message "The implant guide cylinder could not be configured with the selected surgical box".  It is the user's responsibility to follow the implant system manufacturer's placement parameters (e.g., Implantation Level, Maximum Angle/Divergence Correction, etc.) when planning implant placement.  While accuracy with guided surgery is higher than for unguided surgery, linear and angular deviations are possible and have been reported in experimental and clinical studies. The alignment of 3D models with 2D slices should always be checked.  Pathways of imaged nerves cannot be used as sole information for the clinician to make clinical decisions.  NemoScan is intended only for planning a straight path to the starting point of the root canal. The treatment of the root canal is not supported by the guide. ⚫ Product manufacturing:  It is the responsibility of the appliance manufacturer to ensure that the equipment and materials used are suitable for the production of appliances for orthodontic purposes. Nemotec does not manufacture or sell quick milling/prototyping machines and cannot therefore be held responsible for the results of a custom production process where NemoScan software is used as a component.  Please ensure that the required material thickness and setting parameters are applied, when creating the fixture model - according to the specific material and manufacturing machine requirements to be used.  The generated surgical guide files are only valid for the planned surgical procedure.  It is the responsibility of the appliance manufacturer to ensure that the 3D appliance design is suitable for orthodontic purposes.  Note! The physical results you may produce using the Nemotec software may be considered a medical device in your territory. You are respons