SMARTBRUSH. Version 2.5. Software User Guide Revision 1.0. Copyright 2016, Brainlab AG Germany. All rights reserved.

SMARTBRUSH Version 2.5 Software User Guide Revision 1.0 Copyright 2016, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS TABLE OF CONTENTS 1 GENERAL INFORMATION...3 1.1 Contact Data...3 1.2 Legal Information...4 1.3 Symbols Used in This Guide...6 1.4 Intended Use...7 1.5 Compatibility with Medical Devices...8 1.6 Training and Documentation...9 2 USING SMARTBRUSH...10 2.1 Introduction...10 2.2 Starting SmartBrush...12 2.2.1 Screen Layout for General Procedures...13 2.2.2 Layouts for General Procedures...15 2.2.3 Screen Layout for Spine SRS Procedures...18 2.2.4 Layouts for Spine SRS Procedures...19 2.2.5 Image Data Selection...22 2.3 Software Functions...24 2.4 Outlining...26 2.4.1 Creating 3D Objects Using Segmentation...27 2.4.2 Creating 3D Objects Using Same Slice Reconstruction...28 2.4.3 Automatic Generation of Clinical Objects...33 2.5 Finalizing Objects...36 2.5.1 Multi-Modal Options...40 2.6 Volumetric Reports...42 2.6.1 Volumetric Report Functions...43 2.7 Export...45 2.8 Closing SmartBrush...46 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 ii

Contact Data 1 GENERAL INFORMATION 1.1 Contact Data If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region Telephone and Fax Email United States, Canada, Central and South America Tel: +1 800 597 5911 Fax: +1 708 409 1619 us.support@brainlab.com Brazil Tel: (0800) 892 1217 brazil.support@brainlab.com UK Tel: +44 1223 755 333 Spain Tel: +34 900 649 115 France and French-speaking regions Africa, Asia, Australia, Europe Japan Tel: +33 800 676 030 Tel: +49 89 991568 44 Fax: +49 89 991568 5811 Tel: +81 3 3769 6900 Fax: +81 3 3769 6901 support@brainlab.com Expected Service Life Brainlab provides five years of service for software. During this period of time, software updates as well as field support are offered. Feedback Despite careful review, this manual may contain errors. Please contact us at igs.manuals@brainlab.com if you have suggestions as to how we can improve this manual. Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany Related Links 1.4 Intended Use on page 7 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 3

Legal Information 1.2 Legal Information Copyright This guide contains proprietary information protected by copyright. No part of this guide may be reproduced or translated without express written permission of Brainlab. Brainlab Trademarks Brainlab is a registered trademark of Brainlab AG in Germany and/or the US. SmartBrush is a registered trademark of Brainlab AG in Germany and/or the US. Non-Brainlab Trademarks Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries. Integrated 3rd-Party Software This software is based in part on the work of the Independent JPEG Group. This software is based in part on OpenJPEG. The full license and copyright notice can be found here: https://github.com/uclouvain/openjpeg/blob/master/license This software is based in part on libjpeg-turbo. The full license and copyright notice can be found here: https://github.com/libjpeg-turbo/libjpeg-turbo/blob/master/license.md This software is based in part on itextsharp by Bruno Lowagie and Paulo Soares. SmartBrush is proprietary software. The SmartBrush software is protected by copyright. In addition to the SmartBrush software, other software applications may also be installed on the SmartBrush workstation that are licensed under the GNU General Public License. The proprietary software and the free software are used in compliance with the "mere aggregation" clause defined by the GNU GPL. The full terms and conditions of the GNU General Public License can be found here: http://www.gnu.org/licenses/gpl-2.0.html This product includes libtiff 4.0.4 beta, copyright 1988-1997 Sam Leffler and copyright 1991-1997 Silicon Graphics. For a full description of copyrights and license see: www.remotesensing.org/libtiff This software is based in part on Xerces-C++ made available under the Apache Software License: https://xerces.apache.org/xerces-c/ CE Label The CE label indicates that the Brainlab product complies with the essential requirements of European Council Directive 93/42/EEC, the Medical Device Directive ( MDD ). According to the rules established by the MDD, SmartBrush 2.5 is a Class IIb product. NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab. Disposal Instructions Only dispose of electrical and electronic equipment in accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit: http://www.brainlab.com/en/sustainability Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 4

Legal Information Sales in the US US federal law restricts this device to sale by or on the order of a physician. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 5

Symbols Used in This Guide 1.3 Symbols Used in This Guide Warnings Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with equipment misuse. Cautions Cautions are indicated by circular caution symbols. They contain safety-critical information regarding possible problems with the device. Such problems include device malfunctions, device failure, damage to device or damage to property. Notes NOTE: Notes are formatted in italic type and indicate additional useful hints. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 6

Intended Use 1.4 Intended Use Brainlab Elements Brainlab Elements are applications for transferring DICOM data to and from picture archiving and communication systems (PACS) and other storage media devices. They include the following modules for medical procedures: Viewing Image processing Image fusion Segmentation 3D visualization Intended Use The SmartBrush Element provides an easy interface with tools and views to outline anatomical structures in patient image data. The output is saved as 3D DICOM segmentation object and can be used for further processing. Indications for Use Elements Smartbrush 2.5 can be used in all clinical workflows that require to outline anatomical structures in patient image data. The device itself does not have specific clinical indications. Intended User This user guide is intended for healthcare professionals and their assistants. Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system. Responsibility This system solely provides assistance to the surgeon and does not substitute or replace the surgeon s experience and/or responsibility during its use. Medical Electrical Systems For information regarding the configuration of medical electrical systems, see the relevant System User Guide and Technical User Guide. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 7

Compatibility with Medical Devices 1.5 Compatibility with Medical Devices Compatible Brainlab Medical Software SmartBrush 2.5 is compatible with: Patient Data Manager 2.3 - Content Manager 2.3 - DICOM Viewer 3.1 - Patient Selection 4.2 Other Brainlab Software Other compatible Brainlab software may become available after the release of this user guide. If you have questions regarding compatibility of the software, contact Brainlab support. If you are currently running software versions other than those specified above, contact Brainlab support for clarification regarding compatibility. Compatible Non-Brainlab Software SmartBrush 2.5 is compatible with: Microsoft Windows 7 Microsoft Windows 8.1 For detailed and up-to-date information regarding compatible operating systems, please contact Brainlab support. Only critical Microsoft Windows operating system updates are allowed. It is not recommended to download or install updates during patient treatment. It is recommended to protect the system with a state-of-the-art antivirus software. Be aware that this can negatively affect the system performance, e.g., real time scans (also known as on-access scanning, background guard, resident shield, auto-protect) can slow downloading and saving patient data. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 8

Training and Documentation 1.6 Training and Documentation Brainlab Training To ensure safe and appropriate use, before using the system all users should participate in a training program held by a Brainlab representative. Documentation This guide describes complex medical software that must be used with care. It is therefore important that all users of the system: Read this guide carefully before handling the equipment Have access to this guide at all times Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 9

Introduction 2 USING SMARTBRUSH 2.1 Introduction General Information SmartBrush is an image segmentation tool that offers advanced outlining functions to help you, e.g., distinguish healthy tissue from tumors. When you select an area to outline, the software automatically fills in regions of gray value similar to the selected area. The software builds up these segments for each image slice and renders them into a 3D object. SmartBrush within a Spine SRS workflow automatically generates a clinical target volume (CTV) and an Organ at Risk (OAR, cropped) based on a manually drawn object (Gross Tumor Volume or GTV). This target volume can be used for further planning steps. NOTE: SmartBrush uses automatic interpolation when creating objects. SmartBrush Workflow for General Procedures Step 1. Select an image set. 2. Create an object by outlining the structure using: Semi-automatic segmentation using SmartBrush. Manual segmentation using Brush. 3. Finalize the object. SmartBrush Workflow for Spine SRS Procedures (New Objects) Step 1. Select patient data image set. 2. Select your position of interest. 3. Create a Gross Tumor Object (GTV) object by outlining the structure using: Semi-automatic segmentation using SmartBrush. Manual segmentation using Brush. 4. Review the automatically generated Clinical Target Volume (CTV) and Organ At Risk (OAR). 5. Finalize the object. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 10

Introduction SmartBrush Workflow for Spine SRS Procedures (Existing Objects) Step 1. Select an image set with an existing GTV (Gross Target Volume), CTV (Clinical Target Volume) or OAR (Organ at Risk). 2. Edit the existing GTV. 3. Choose whether to link or unlink the CTV (or cropped OAR) to the GTV. NOTE: The objects are linked together meaning that they are dependant on each other. A GTV update initiates an OAR update. 4. Finalize the object. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 11

Starting SmartBrush 2.2 Starting SmartBrush Before You Begin Use Patient Selection to select the patient and desired data. Refer to the Software User Guide, Content Manager and Patient Selection for more information. Anomaly Detection SmartBrush uses anomaly detection, if it is present on the system when SmartBrush is started. This means that SmartBrush, in a general workflow, will focus and zoom its views on the abnormality detected. Select and Start Your Workflow Figure 1 Step 1. Select your workflow: E.g., Cranial > Planning. 2. Choose SmartBrush from within the workflow on the main screen of Content Manager. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 12

Screen Layout for General Procedures 2.2.1 Screen Layout for General Procedures General Information SmartBrush can be used to draw objects, e.g., tumors. It allows an accurate voxel-based object correction or segmentation. Screen and Toolbar Layout 2 3 4 5 6 7 8 9 1 Figure 2 No. 1 2 3 4 5 6 7 8 9 Explanation Main view containing, axial, coronal, sagittal and 3D reconstructions as a preview of the current result. Currently selected object Alerts: Contains process information Data: Opens the data selection window and view layout options Home: Takes you to Content Manager Navigation tools for defining the region of interest Smart Brush toggle switch for selecting brush tools Outlining tools for highlighting objects Displays the currently selected object. Click to center the object. Related Links 2.2 Starting SmartBrush on page 12 2.3 Software Functions on page 24 2.4 Outlining on page 26 2.4.3 How to Outline Objects Using Smart Brush on page 29 2.4.3 How to Outline Objects Using Brush on page 30 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 13

Screen Layout for General Procedures 2.5 Finalizing Objects on page 36 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 14

Layouts for General Procedures 2.2.2 Layouts for General Procedures Layout Types Figure 3 View ACS Side By Side Gallery Explanation Displays four different views of equal dimensions in the main screen. Axial, Coronal, and Sagittal reconstructions of the image set, with a basic 3D view. Displays two image sets of interest in the main screen. Displays the original image slices from the chosen image set. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 15

Layouts for General Procedures ACS View ① Figure 4 The ACS view displays slices of the selected image set in Axial, Coronal, and Sagittal views. A basic 3D visualization is provided ①. Side By Side View ① Figure 5 The Side By Side view displays two image sets side by side arranged in an ACS configuration ①. You choose the image set to be displayed by selecting them from the data pool. Use Pan, Zoom and Scroll accordingly to review your image set. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 16

Layouts for General Procedures Gallery View 1 2 Figure 6 The Gallery view displays the original slices 1 on screen from within the same image set. Use Swipe 2 to navigate up or down through the slices within the same image set. NOTE: It is not possible to outline objects within the Gallery view. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 17

Screen Layout for Spine SRS Procedures 2.2.3 Screen Layout for Spine SRS Procedures General Information SmartBrush in Spine SRS workflows can be used to draw objects, e.g., tumors. It also proposes CTV/OAR cropped objects according to RTOG guidelines. It allows an accurate voxel-based object correction or segmentation. Spine SRS Screen and Toolbar Layout ② ③ ④⑤⑥ ⑦ ⑧ ⑨ ⑩ ① Figure 7 No. Explanation ① Main view containing, axial, coronal, sagittal and 3D reconstructions as a preview of the current result ② Switch for changing between axial, coronal, sagittal views ③ Currently selected object ④ Alerts: Contains process information ⑤ Data: Opens the data selection window and view layout options ⑥ Home: Takes you to Content Manager ⑦ Navigation tools for defining the region of interest ⑧ Smart Brush toggle switch for selecting brush tools ⑨ Outlining tools for highlighting objects ⑩ Currently active GTV/CTV/OAR triple Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 18

Layouts for Spine SRS Procedures 2.2.4 Layouts for Spine SRS Procedures Layout Types Figure 8 View Spine Side By Side Gallery Explanation Displays Axial, Coronal and Sagittal reconstructions of one image set, with either Axial, Coronal and Sagittal reconstructions of the other image set and a view showing vertabrae. NOTE: Spine SRS workflows only. Displays two image sets of interest in the main screen. Displays a selection of image slices from the chosen image set. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 19

Layouts for Spine SRS Procedures Spine View ① ② ③ Figure 9 The Spine view displays two image sets. One set, showing an ACS configuration, with the other displaying either Axial, Coronal or Sagittal in a slice set at the bottom of the screen. Additionally displayed is a reconstruction of the spine vertabrae, which can be individually highlighted. ①. You can switch between the two image sets by selecting them. Use Pan, Zoom and Scroll accordingly to review your image set. NOTE: Spine SRS workflows only. Side By Side View ① Figure 10 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 20

Layouts for Spine SRS Procedures The Side By Side view displays two image sets side by side arranged in an ACS configuration ①. You can switch between the two image sets by selecting them. Use Pan, Zoom and Scroll accordingly to review your image set. Gallery View ① ② Figure 11 The Gallery view displays the original slices ① on screen from within the same image set. Use Swipe ② to navigate up or down through the slices within the same image set. NOTE: It is not possible to outline objects within the Gallery view. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 21

Image Data Selection 2.2.5 Image Data Selection General Information SmartBrush automatically chooses the "best" data sets to be displayed. In each of the view layouts, it is possible to choose the data set to be displayed using the data menu. NOTE: For further information contact Brainlab support. ACS and Gallery View Layouts Figure 12 ACS and Gallery view layouts display a single data set at any given time. To select your displayed data set, perform the following: Step 1. Select the layout. 2. Select the data set. Spine and the Side by Side Layouts Figure 13 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 22

Image Data Selection Spine and the Side by Side layouts offer multi-modal and mono-modal display options. To select your displayed data set, perform the following: Step 1. Select the layout. 2. Select layout section that you intend to display. 3. Select the data set. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 23

Software Functions 2.3 Software Functions Image Viewing Functions Button Function Scroll: Drag the mouse pointer through image slices. NOTE: You can use the mouse wheel as a shortcut. Zoom: Drag the mouse pointer: Down to zoom in Up to zoom out NOTE: You can use CTRL on the keyboard and the mouse wheel as a shortcut. Pan: Displays vertical and horizontal planes indicated by yellow lines on the images. NOTE: When Pan is selected in one view, the other views update accordingly. NOTE: You can use CTRL on the keyboard and the left mouse button as a shortcut. The position of the click/touch defines the view center. Windowing: Manually adjust the image brightness and contrast. Drawing and Outlining Tools Button Function Smart Brush segments all connected pixels with similar gray values in the defined area. NOTE: Defining a larger area increases the potential gray value scale. Brush segments all connected pixels. NOTE: Brush highlights the area based on where you marked and adds/removes segmented voxels in a small area around the marked area creating smooth object contours. Smart Erase removes pixels based on areas with similar gray values in the defined area. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 24

Software Functions Button Function Erase removes connected pixels manually. Undo undoes the last change made or multiple consecutive steps. Adjust the brush size for object outlining. How to Set the Resolution You can set a fixed resolution for all objects, independent from the slice sets used for drawing. This must be set up by Brainlab support. By default, an object is set to the same resolution as the first slice set selected. It is recommended to use slice sets with a resolution that is high enough to represent the structure to be segmented. Verify in the 2D views that the object generated by the SmartBrush function is correct. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 25

Outlining 2.4 Outlining General Information Brush and Smart Brush are the main tools used for outlining 3D objects. Brush gives the option of outlining the areas of interest manually. Like Smart Brush, the software builds up each segmented image slice into a 3D object. It allows an accurate voxel-based object correction or segmentation with more restricted interpolation. Brush is recommended for correcting structures. You can correct the structure on a slice by slice basis, which aids the interpolation process. Selecting Smart Brush Tools 1 Figure 14 Select Smart Brush drawing tools by toggling the switch 1 on/off. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 26

Creating 3D Objects Using Segmentation 2.4.1 Creating 3D Objects Using Segmentation How to Create 3D Objects Using Segmentation - Smart Brush Only After segmenting two slices in the ACS view, a 3D object is created that considers the actual drawn shape and the anatomical data visible in the surrounding area. 2 1 3 Figure 15 Steps 1. Outline the shape of the structure in one reconstruction 2 e.g., the coronal view. 2. Outline the shape of the structure in another reconstruction e.g., the sagittal view 1. The 3D object is automatically created 3. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 27

Creating 3D Objects Using Same Slice Reconstruction 2.4.2 Creating 3D Objects Using Same Slice Reconstruction General Information Using Smart Brush with two non-adjacent slices in the same orientation, the space between the slices is interpolated in order to create the 3D object. NOTE: If you switch, e.g., from an axial to a sagittal view, interpolation remains activated. To deactivate Smart Brush while switching views, choose another function from the menu, e.g., Pan. Creating Objects in Reconstructed Views Creating objects in reconstructed views, i.e., (containing images that have been reconstructed from original image slices) differs from creating objects in original slices. In reconstructed views, interpolated images are used, which may not show all details as expected (e.g., borders may be blurred). How to Create Interpolated Objects 1 2 3 Step Figure 16 1. Create a segmented region on one image slice 1 using Smart Brush or Brush. 2. Scroll through the image slices to the next distinct plane. 3. Create another segmented region on a different slice 2. 4. The area between the two slices is interpolated 3, creating a 3D view of the object. NOTE: Generally, thin and/or small objects in the 3D view may not be accurately displayed due to 3D mesh simplification. Review them in the 2D slice views 1. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 28

Creating 3D Objects Using Same Slice Reconstruction How to Outline Objects Using Smart Brush Figure 17 Step 1. Go to the region of interest using the Zoom, Scroll and Pan functions. 2. Select Smart Brush. 3. Highlight the areas to be segmented. Trace an outline with a brush stroke, keeping it slightly inside the object. The voxel lines follow the contours of the object.the region that is outlined is determined by the gray values and the contrast of the image. Smart Brush segments all connected pixels with similar gray values in the defined area. Defining a larger area increases the potential gray value scale. 4. If edges of the segmented area are not correctly separated from the surrounding area, use Erase to define these borders more accurately. If a mouse is used, use the right mouse button to erase when Smart Brush is active. 5. Scroll to next slice. 6. Repeat the highlighting steps until the object has been created in all relevant slices. Optionally, use 3D interpolation to outline the whole object volume. 7. Verify the object. 8. Select Done. Related Links 2.3 Software Functions on page 24 2.4 Outlining on page 26 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 29

Creating 3D Objects Using Same Slice Reconstruction 2.5 Finalizing Objects on page 36 How to Outline Objects Using Brush Smart Brush by default uses multi-modal information for outlining. However, this is not available for Brush. Figure 18 Step 1. Center and zoom to the region of interest using the Zoom, Scroll and Pan functions. 2. Select Brush. 3. Make a brush stroke over the area to be segmented. 4. Brush segments all connected pixels. Brush highlights using locally restricted interpolation to smoothly add the marked area to a 3D object. If edges of the segmented area are not correctly separated from the surrounding area, use Erase to define these borders more accurately. 5. Use Scroll to proceed to the next slice. 6. Repeat the highlighting steps until the object has been created in all relevant slices. You can skip slices using 3D interpolation. The information between the slices is then interpolated. 7. Verify the object. 8. Select Done. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 30

Creating 3D Objects Using Same Slice Reconstruction Related Links 2.3 Software Functions on page 24 2.4 Outlining on page 26 How to Outline Objects Using Smart Brush for Spine SRS Procedures ① ② ③ ④ ⑤ Figure 19 Step 1. Center and zoom to the region of interest using the Zoom, Scroll and Pan functions. 2. Ensure the Smart Brush selector is switched on ⑤ and select Smart Brush. 3. Select your vertebra ①. 4. Highlight the area to be segmented ③. Trace an outline with a brush stroke, keeping it slightly inside the object. The voxel lines follow the contours of the object. The region that is outlined is determined by the gray values and the contrast of the image. SmartBrush segments all connected pixels with similar gray values in the defined area. Defining a larger area increases the potential gray value scale. 5. If edges of the segmented area are not correctly separated from the surrounding area, use Erase to define these borders more accurately. If a mouse is used, use the right mouse button to erase when SmartBrush is active. 6. Scroll to next slice or continue outlining in a perpendicular reconstruction. 7. Repeat the highlighting steps until the object has been created in all relevant slices. Optionally, use 3D interpolation to outline the whole object volume. 8. Verify the drawn and automatically generated objects (GTV ②, CTV ③ and OAR, cropped objects ④) by selecting them in the tool area list and reviewing them. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 31

Creating 3D Objects Using Same Slice Reconstruction Step As soon as you begin to outline an object, a corresponding target volume (CTV) and an organ at risk (OAR) are generated. The CTV and OAR update accordingly throughout the GTV outlining process. 9. Select Done. Related Links 2.3 Software Functions on page 24 2.4 Outlining on page 26 2.4.3 How to Create Interpolated Objects on page 28 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 32

Automatic Generation of Clinical Objects 2.4.3 Automatic Generation of Clinical Objects General Information The automatic generation of a clinical target object follows the guidelines as published by Brett W. Cox et al in 2012. Cox B.W., Spratt D.E., Lovelock M., et al. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys 2012; 83:e597-605 Smartbrush generates a cropped OAR which is calculated based on the position of the clinical target (i.e., the cropped OAR covers the length of the spine where the CTV is located +/- 5 mm from top/bottom). This is visible in both 2D and 3D views. About Clinical Target Objects 1 2 3 Figure 20 As soon as you start a GTV, SmartBrush generates: CTV OAR e.g., Spinal Canal, cropped (default) No. 1 2 3 Explanation Gross Tumor (GTV) Clinical Target Volume (CTV) Organ at Risk (OAR) e.g., Spinal Canal, cropped Object Linking All three objects are linked, if any changes are made to the GTV through outlining, this propogates to the CTV. The flow is unidirectional: Figure 21 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 33

Automatic Generation of Clinical Objects Clinical Target Volume Example 1 6 2 5 3 4 Figure 22 No. 1 2 3 4 5 6 Explanation Vertebral body Pedicle Transverse processes/laminae Spinous process Transverse processes/laminae Pedicle Rules for Clinical Target Generation The automatic generation of a clinical target object follows these rules: When the Gross Tumor Volume involves a unilateral pedicle, the pedicle and the ipsilateral transverse process/lamina are included in the Clinical Target Volume. When the Gross Tumor Volume involves the spinous process, the entire spinous process and bilateral laminae are included in the Clinical Target Volume. When the Gross Tumor Volume involves the vertebral body and bilateral pedicle/transverse processes, the entire vertebral body, bilateral pedicles, transverse processes/laminae and spinous process are included in the Clinical Target Volume. When the Gross Tumor Volume involves the vertebral body and one unilateral pedicle, the entire vertebral body, pedicle and ipsilateral transverse process/lamina are included in the Clinical Target Volume. When the intersection between the Gross Tumor Volume and one sector is not empty, this sector is included in the Clinical Target Volume. The sector selection dynamically updates when changes occur to the Gross Tumor Volume. The Clinical Target Volume calculation updates with every change to the Gross Tumor Volume except for, changing the name, color or comments. Those changes do not trigger an update of the Clinical Target Volume (only the role and actual object data). Objects with Disconnected Volumes A dialog is displayed if you leave SmartBrush after generating objects (new or modified) with disconnected volumes. An object is treated as a disconnected volume if the total object volume minus the volume of the biggest component is bigger than 0.1 cm³. NOTE: Spine SRS does not support disconnected volumes for dose planning. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 34

Automatic Generation of Clinical Objects Reviewing Objects A dialog is displayed if you leave SmartBrush without reviewing the automatically generated objects. The objects are saved even if they are not reviewed. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 35

Finalizing Objects 2.5 Finalizing Objects General Information You can edit or amend objects at any time during the creation process using the data selection menu. Accessing Data Selection Button Function Select Data from the main screen to access images, objects and to view/edit their respective properties. About Data Selection 1 2 3 Figure 23 Within data selection, you can view selected image data 2 and objects 1, as well as add additional data or objects by pressing MORE. All are displayed as thumbnail images showing their respective properties: Images - Image modality - Slice distance - Slice sets Objects - Volume: Displays the calculated object volume - Basis: Image set where the object is defined Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 36

Finalizing Objects - Name: Enter your object name - Type: Choose an object type from the drop-down - Role: Choose a role attribute from the drop-down - Comment: Add applicable comments Data Selection Functions Button Function Amend or assign a color to an object. Create a volumetric report. Remove an object from the current selection. Enable multi-modal object creation. NOTE: When de-activated, the segmentation algorithm only uses information of the currently displayed slice set to calculate an object. Create a new object. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 37

Finalizing Objects How to Add a New Object Step 1. Select the Objects drop-down. 2. Select New Object from the Objects drop-down. 3. By default, Type is set as Tumor and Role is set as Undefined. You can change these using the drop-down menu presets e.g, set Role to CTV. Type and Role are added automatically even if you start outlining without selecting New Object first. 4. Return to the main screen and outline your object using the outlining tools, e.g, Smart Brush > Brush. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 38

Finalizing Objects How to Modify Existing Object Properties 1 2 Figure 24 Step 1. Select the Objects drop-down 2. 2. Select relevant object from the Objects drop-down. Edit the Basis, Name, Type, Role and Comment 1 as needed. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 39

Multi-Modal Options 2.5.1 Multi-Modal Options General Information If you are using slice sets co-registered by Image Fusion, you can display and modify image objects in all fused slice sets. A multi-modal object is created automatically when using different sets for segmentation. If the multi-modal drawing is performed in a multi-modal layout (side by side or spinal view layout), the two data sets displayed in the views are considered by the algorithm. If the multi-modal drawing is performed in a mono-modal view layout: The first two data sets in which the object is drawn are considered by the algorithm. With a third data set, the multi-modal algorithm takes the information from the last two selected data sets into consideration to draw the object. Visibility Options 1 Use 1 to turn object visibility on or off. Figure 25 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 40

Multi-Modal Options Example Containing Multi-Modal Image Sets Figure 26 Option Outline the tumor in an MR-T1 set Switch view to a fused MR-T2 set and continue outlining Information Data Used for Outlining MR-T1 set MR-T1 and MR-T2 Only the gray values of two image sets are used. If you select a third image set, the first image set is deselected and no longer displayed. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 41

Volumetric Reports 2.6 Volumetric Reports General Information A Volumetric Report contains information about the volume of an object, its area within one slice based on the longest diameters (Macdonald Criteria) and the longest diameter itself (Response Evaluation Criteria in Solid Tumors). Handling Volumetric Information A Volumetric Report: Is created for an object if you press the report icon. Stays valid as long as the according object is not modified. Is stored with the patient data as long as the object is not modified. Calculates objects to two decimal places if it is less than 10 cm 3. Anything greater is calculated to one decimal place. Existing reports can be reviewed using Image Viewer. Existing reports can be stored/exported using the Export function of Content Manager. The shape and position of an object must be verified in SmartBrush before creating a report. The report itself only gives information about volumetric measurements. Values calculated from an outlined object depend on the resolution of the corresponding image set including the object. NOTE: The Macdonald Criteria calculated on the Volumetric Report is performed using the original slices. Hence, the orientation to which the Macdonald Criteria is applied is equal to the scan direction. The resolution of the image series determines the accuracy of the method. Therefore, the object displayed in the software might have a slightly different result due to interpolation. NOTE: Contact Brainlab support for further information. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 42

Volumetric Report Functions 2.6.1 Volumetric Report Functions Button Function Pan around the report. Zoom to an area of the report. Fits the report to the width of the screen. Closes the report. Saves the report to a specified location. Prints the report to a specified printer. How to Create a Volumetric Report Figure 27 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 43

Volumetric Report Functions Step 1. In the Selected Data dialog, SmartBrush generates a Volumetric Report. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 44

Export 2.7 Export How to Export For information on exporting from the system, see the Content Manager Software User Guide. NOTE: If the data generated by the application (i.e., objects, segmentations) are used within follow-up applications, the results must be inspected carefully after the import into the follow-up application. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 45

Closing SmartBrush 2.8 Closing SmartBrush Saving Data on Shutdown Always finalize your current task before closing the software. Always close the software before shutting down the system. Data is not saved automatically if the system is shut down without properly closing the software. How to Close SmartBrush Step 1. Before closing, finalize your current task by selecting Done. 2. Select Exit from the main screen of Content Manager. Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 46

INDEX INDEX Symbols 3D object... 27 A ACS View... 16 B before you begin...12 Brush using Brush...30 C compatible Brainlab medical software Content Manager...8 DICOM Proxy... 8 DICOM Viewer...8 Patient Selection...8 create a Volumetric Report... 43 objects in reconstructed views...28 same slice reconstruction... 28 D data save on shutdown...46 disposal instructions... 4 E Export... 45 G Gallery View... 17,21 H how to close SmartBrush... 46 create a Volumetric Report... 43 create objects in reconstructed views...28 use Brush... 30 I image resolution... 25 interpolation...28 L layouts types... 15,19 M multi-modality... 37 O objects creating objects in reconstructed views...28 interpolated objects... 28 properties...38,39 open SmartBrush... 12 P Pan... 24,43 R resolution...25 S saving data on shutdown...46 Scroll... 24 Side By Side View... 16,20 SmartBrush general information...10 how to close...46 layouts... 15,19 object creation workflow... 10,11 using SmartBrush... 29 using SmartBrush for Spine SRS... 31 software opening SmartBrush...12 Spine View... 20 support... 3 sustainability...4 U Undo...25 V Views ACS View... 16 Gallery View... 17,21 Side By Side View... 16,20 Spine View...20 visibility... 40 Volumetric Report Print... 43 report functions...43 Save... 43 volumetric information... 42 W WEEE...4 Windowing...24 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 47

INDEX Z Zoom... 24,43 Software User Guide Rev. 1.0 SmartBrush Ver. 2.5 48

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