SMARTBRUSH ANGIO. Version 1.0. Software User Guide Revision 1.0. Copyright 2014, Brainlab AG Germany. All rights reserved.

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3 TABLE OF CONTENTS TABLE OF CONTENTS GENERAL INFORMATION...5 Contact Data and Legal Information...5 Legal Information...6 Symbols...7 Intended Use...8 Compatibility with Medical Devices...9 Non-Brainlab Software...10 Training and Documentation...11 USING SMARTBRUSH ANGIO...13 Introduction...13 Opening Smartbrush Angio...14 Selecting Data...15 Fusion...18 ROI (Region of Interest)...22 Using Smartbrush Angio...25 Closing Smartbrush Angio...31 INDEX...33 Software User Guide Rev. 1.0 Smartbrush Angio Ver

4 TABLE OF CONTENTS 4 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

5 GENERAL INFORMATION 1 GENERAL INFORMATION 1.1 Contact Data and Legal Information Contact Data Support If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region Telephone and Fax United States, Canada, Central and South America Tel: (800) Fax: (708) Brazil Tel: (0800) us.support@brainlab.com UK Tel: Spain Tel: +34 (900) France and French-speaking regions Tel: Africa, Asia, Australia, Europe Tel: Fax: support@brainlab.com Japan Tel: Fax: 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 Kapellenstr Feldkirchen Germany Software User Guide Rev. 1.0 Smartbrush Angio Ver

6 Contact Data and Legal Information 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. 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 itextsharp by Bruno Lowagie and Paulo Soares. Smartbrush Angio is proprietary software. The Smartbrush Angio software is protected by copyright. In addition to the Smartbrush Angio software, other software applications may also be installed on the Smartbrush Angio 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: CE Label The CE label shows that the Brainlab product complies with the essential requirements of Medical Device Directive (MDD). According to MDD, Council Directive 93/42/EEC, Smartbrush Angio 1.0 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: Sales in the US US federal law restricts this device to sale by or on the order of a physician. 6 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

7 GENERAL INFORMATION 1.2 Symbols 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 Angio Ver

8 Intended Use 1.3 Intended Use Using the System Intended Use Smartbrush Angio is an application for the outlining of anatomical vascular structures and pathologies in medical images. Intended User This user guide is intended for healthcare professionals and/or their staff. Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system. Responsibility This application solely provides additional assistance to the surgeon or user and does not by any means substitute or replace the surgeon s or user 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. 8 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

9 GENERAL INFORMATION 1.4 Compatibility with Medical Devices Brainlab Medical Software Compatible Brainlab Medical Software Smartbrush Angio 1.0 is compatible with: Content Manager 2.0 DICOM Viewer 2.0 Patient Browser 4.0 DICOM Proxy 3.2 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. Software User Guide Rev. 1.0 Smartbrush Angio Ver

10 Compatibility with Medical Devices Non-Brainlab Software Compatible Non-Brainlab Software Smartbrush Angio 1.0 is compatible with: Microsoft Windows 7 Microsoft Windows 8 For information regarding compatible service packs, 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. 10 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

11 GENERAL INFORMATION 1.5 Training and Documentation Overview 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 Angio Ver

12 Training and Documentation 12 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

USING SMARTBRUSH ANGIO 2 USING SMARTBRUSH ANGIO 2.1 Introduction Overview General Information Smartbrush Angio is an application for outlining vascular structures and pathologies in medical images.

13 USING SMARTBRUSH ANGIO 2 USING SMARTBRUSH ANGIO 2.1 Introduction Overview General Information Smartbrush Angio is an application for outlining vascular structures and pathologies in medical images. It allows you to combine a 3D image series with an unlocalized 2D dynamic angiography in order to simultaneously review the image information. Based on the imaging input, it is possible to outline vascular structures as 3D objects for further processing. Smartbrush Angio Workflow Workflow 1. Select an image series. 2. Create Fusion. 3. Highlight the region of interest in the image using ROI. 4. Verify and, if necessary, correct the 3D vascular object using Brush/Smartbrush Angio. Workflow Indicator There is a visual workflow indicator for Smartbrush Angio, which displays where you are in the workflow. Figure 1 Use the Back and Next buttons to navigate through the workflow. Software User Guide Rev. 1.0 Smartbrush Angio Ver

14 Opening Smartbrush Angio 2.2 Opening Smartbrush Angio How to Open the Angio Planning Workflow Step Select Angio Planning from the workflow options in Content Manager. 14 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

USING SMARTBRUSH ANGIO 2.3 Selecting Data Selecting Patients How to Select a Patient Steps 1. Choose a patient in Patient Browser. 2. Choose Select.

15 USING SMARTBRUSH ANGIO 2.3 Selecting Data Selecting Patients How to Select a Patient Steps 1. Choose a patient in Patient Browser. 2. Choose Select. NOTE: For further information see the Patient Browser Software User Guide. How to Select Images 2 1 Steps Figure Select the image series you would like to use 1. The images appear under Selected Data 2. NOTE: If any required data type is missing, you are notified in the info area 3. NOTE: Pre-existing Smartbrush Angio results can also be loaded. 2. Select OK. NOTE: You can only select OK when all required image series data is selected. NOTE: For further information see the Software User Guide for Content Manager, Patient Browser and DICOM Viewer. Software User Guide Rev. 1.0 Smartbrush Angio Ver

Selecting Data Image Data Requirements Smartbrush Angio requires image series data containing vascular details. Images such as CT or MRI are outlined automatically.

16 Selecting Data Image Data Requirements Smartbrush Angio requires image series data containing vascular details. Images such as CT or MRI are outlined automatically. Data selection only loads image series data which is relevant for the angio procedure and omits all data that is not relevant. Suitable data is: 2D image series: Frontal and lateral angiographic projections are required for the registration/ fusion with the 3D image series. The dynamic flow information is also used for visualization and comparison with the anatomical data. 3D MRI or CT with contrast: Enhanced contrast is necessary in order to distinguish the vascular information. Vessel objects: Vessel objects are automatically outlined based on the selected 3D modalities with contrast. NOTE: Contact Brainlab support for more scanning recommendations. Vessel Segmentation The selected and highlighted image series (marked by an orange border), triggers the priority for vessel segmentation. When different imaging modalities are selected, the highlighted image series is used first for vessel segmentation. The segmentation progress and image series is displayed in the info area. How to Define Image Orientation For angio planning, a frontal and lateral images series is required. Usually the orientation information is shown in the DICOM header 1. If the scanner does not save the orientation, you can manually: Steps 1. Select the pen icon Select the image orientation from the available options Select OK. How to Remove Images Step Select the X 2 to remove the image series from Selected Data. 16 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

17 USING SMARTBRUSH ANGIO How to Finalize Data Selection Step After data selection, select Next. Saving Changes When navigating away from patient selection, you are prompted by the following dialog: Options Figure 3 Save Discard Saves created content and returns you to patient selection. Deletes all created content and returns you to patient selection. Software User Guide Rev. 1.0 Smartbrush Angio Ver

18 Fusion 2.4 Fusion Fusing Images Figure 4 After selecting an image series, the software prompts you to fuse together (co-register) the image data. Selecting Fusion automatically fuses together the 2D and 3D image series. The images are fused together based on anatomical structures common to both image series. Review the fusion result before proceeding. 18 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

USING SMARTBRUSH ANGIO Pre-Fusion Manual Alignment 2 3 4 5 6 1 7 Figure 5 Aligning the images manually aids the fusion algorithm and improves results.

19 USING SMARTBRUSH ANGIO Pre-Fusion Manual Alignment Figure 5 Aligning the images manually aids the fusion algorithm and improves results. You can change the scale and rotate the 3D vessel layer about its axes, to better match the underlying 2D image data. No Explanation Illustrates image and vessel orientation. Rotate the 3D vessel layer horizontally. Rotate the 3D vessel layer on the X-Y axis. Rotate the 3D vessel layer vertically. Increase or decrease 3D image scale. Play the angiogram. Move slider to specific points within the angiogram. How to Adjust the 3D Vessel Layer Steps 1. Rotate or adjust the 3D vessel layer in relation to the underlying 2D image. 2. Once results are satisfactory, select Next to continue. Software User Guide Rev. 1.0 Smartbrush Angio Ver

Fusion How to Create an Automatic Fusion Steps 1. Select Fusion to start the fusion between the image series. 2. Verify fusion. 3. Select Next to continue.

20 Fusion How to Create an Automatic Fusion Steps 1. Select Fusion to start the fusion between the image series. 2. Verify fusion. 3. Select Next to continue. Fusion Dialog Figure 6 It is possible to skip the Fusion step without co-registering the image series data. It is recommended to select Yes and proceed with an automatic fusion upon viewing the above dialog. Fusion Functions Function Fusion: Optimizes the manually adjusted fusion between the image series. Select Undo Fusion to undo the automatic image fusion. NOTE: During an automatic fusion, all other functions are disabled until the fusion is complete. Reset and Undo Fusion share the same location on the toolbar. When Undo Fusion is used after an automatic fusion, it returns the vessel to its manually adjusted pre-fusion state. Reset returns the vessel back to its initial position, prior to manual adjustment. NOTE: After Reset is used, the function is disabled until the vessel is repositioned. 20 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

21 USING SMARTBRUSH ANGIO Function Figure 7 Vessel Visible: Turns the vessel overlay on or off, to aid manual fusion adjustment. The default transparency of the vessel object is 50% so that the background image is also visible. Vessel Complexity: increases or decreases the level of vessel complexity shown on the image overlay. NOTE: Vessel Complexity is used to remove vessel segmentation artifacts and improve fusion results. Only the visible vessel structures are considered for the automatic fusion. General Functions Function Opens the main screen of Content Manager. Opens data selection. Confirms the results of your current step and advances to the next step. Returns to previous step. The results are not automatically saved. How to Finalize Fusion Step After fusion editing, select Next. Software User Guide Rev. 1.0 Smartbrush Angio Ver

ROI (Region of Interest) 2.5 ROI (Region of Interest) General Information Use ROI to define regions of interest, e.g., a nidus on the angiogram. How to Use ROI 2 3 1 Figure 8 Steps 1.

22 ROI (Region of Interest) 2.5 ROI (Region of Interest) General Information Use ROI to define regions of interest, e.g., a nidus on the angiogram. How to Use ROI Figure 8 Steps 1. Scroll through the images using the sliders 1 (or mouse wheel) to find regions of interest. 2. Select ROI Brush Highlight a region of interest in one view by drawing an outline 2. The area is marked in blue and creates a ray 3 in the other view. NOTE: If necessary, reduce the brush size to 50% by pressing the shift key (available on the PC only) when drawing an outline. Highlight the region of interest in the other view. NOTE: If the rays in both views fail to intersect, Next is disabled. Adjust the ROI Brush stroke. 5. If needed, use ROI Erase to define the borders more accurately. NOTE: If a mouse is used, use the right mouse button to erase when ROI Brush is active. Optionally, select Undo to undo previous brush/erase steps. 22 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

23 USING SMARTBRUSH ANGIO Steps 6. Verify the ROI Brush object. 7. Select Next. View Options Figure 9 Use the drop down menu to switch between DSA (grayscale) and CIP (color) views to help identify regions of interest more easily. Software User Guide Rev. 1.0 Smartbrush Angio Ver

ROI (Region of Interest) ROI Views 2 1 Figure 10 No. View Explanation 1 2 CIP DSA Color Intensity Projection: Dynamic angio flow with color-coded time information based on DSA images.

24 ROI (Region of Interest) ROI Views 2 1 Figure 10 No. View Explanation 1 2 CIP DSA Color Intensity Projection: Dynamic angio flow with color-coded time information based on DSA images. Digital Subtraction Angiography: Displays the angiography imaging in grayscale. How to Finalize ROI Editing Step After ROI editing, select Next. 24 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

25 USING SMARTBRUSH ANGIO 2.6 Using Smartbrush Angio General Information After ROI definition, Smartbrush Angio automatically detects and builds a 3D nidus object based on the selected anatomical image data. This object is displayed on each slice of your patient image series. NOTE: If the nidus detection algorithm is unable to find useful data within your selected ROI, it creates a default nidus with the same shape as the ROI you defined. Main Screen Overview Smartbrush Angio allows you to manually highlight and fine-tune regions of interest within individual slices. By default the 3x3 View displays an overview of the detected 3D nidus object as slices. Each slice is available for editing. If you select a different view 2, the 3x3 View 4 updates accordingly Figure 11 No Explanation Angiogram views, e.g., lateral left or frontal right and their respective controls for angiogram playback. View options: Axial Coronal Sagittal 3D Orange border indicates the view in use in the main screen area Image slices of the 3D nidus object Toolbar Drop down view selection menu Adjustable slice thickness slider Software User Guide Rev. 1.0 Smartbrush Angio Ver

26 Using Smartbrush Angio Toolbar Functions Button Function Scroll: scroll through image slices by dragging the mouse pointer across the current slice. Zoom: zoom to the region of interest by dragging the mouse pointer across the slice. Toggle between 3x3 View and Single View and display a drop-down menu of available fused images. Pan: pan to region of interest on the images. The position of the click/touch defines the view center. NOTE: In 3x3 View, when Pan is selected in one view, the other views update accordingly. Retrace outlines of the 3D nidus object. Retouch individual slices of the 3D nidus object. NOTE: Single View only. Correct imperfections and define borders more accurately. Select Undo to undo the last change made. Adjust the brightness by dragging the mouse pointer across the current slice. Rotate around the 3D object using Rotate. NOTE: Available in the 3D View only. 26 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

27 USING SMARTBRUSH ANGIO How to Use Smartbrush for Editing Nidus Objects Steps 1. Select 3x3 View from View options. 2. Center and zoom to the region of interest using the Zoom, Scroll and Pan functions. 3. Select Smartbrush. 4. Drag Smartbrush over your highlighted area in a brush-like motion. 5. Smartbrush highlights all connected pixels. NOTE: Smartbrush highlights the area you marked and creates an object using 3D interpolation. 6. If any edges of the highlighted area are not correctly separated from the surrounding area, use Erase to define these borders more accurately. 7. Use Scroll to proceed to the next slice. 8. Adjust Slice Thickness if necessary (see page 29 for more information). 9. Repeat steps 4-8 until you are satisfied with the results. 10. Verify the 3D nidus object. 11. Select Done to complete angio planning. Content Manager opens. How to Use Brush for Editing Nidus Objects Steps 1. Select Single View from View options. 2. Center and zoom to the region of interest using the Zoom, Scroll and Pan functions. 3. Select Brush. 4. Drag Brush over your highlighted area in a brush-like motion. 5. Brush highlights all connected pixels and creates an object without interpolation. NOTE: Brush highlights the area you marked and does not add or remove voxels automatically. Software User Guide Rev. 1.0 Smartbrush Angio Ver

Using Smartbrush Angio Steps 6. If any edges of the highlighted area are not correctly separated from the surrounding area, use Erase to define these borders more accurately. 7.

28 Using Smartbrush Angio Steps 6. If any edges of the highlighted area are not correctly separated from the surrounding area, use Erase to define these borders more accurately. 7. Use Scroll to proceed to the next slice. 8. Adjust Slice Thickness if necessary (see page 29 for more information). 9. Repeat steps 4-8 until you are satisfied with the results. 10. Verify the 3D nidus object. 11. Select Done.to complete angio planning Content Manager opens. Saving the Nidus Object The 3D nidus object is saved in the workflow upon selecting Done. The default naming convention for the 3D nidus object is: Nidus ( 3D image series name ) How to View in 3D Figure 12 Steps 1. Select 3D from the view options 1. The main screen displays the 3D view. 2. Center and zoom to the region of interest using the Zoom, Scroll and Pan functions To aid viewing, increase or decrease the Vessel Complexity using the slider Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

USING SMARTBRUSH ANGIO Visualization Functions 1 Figure 13 You can view 2D angiography projections as videos to aid correct nidus detection. Steps 1.

29 USING SMARTBRUSH ANGIO Visualization Functions 1 Figure 13 You can view 2D angiography projections as videos to aid correct nidus detection. Steps 1. Select either the frontal or left/right angiography projection from the left side of the screen. 2. Click the play/pause button 1 to play the video in the main screen view. Alternatively, click the play button directly in the chosen project window. Viewing Options Options DSA View CIP View Red-Blue View Explanation Digital Subtraction Angiography: Displays the angiography imaging in grayscale. Color Intensity Projection: Dynamic angio flow with color-coded time information based on DSA images Red-blue represents the early-late contrast flow phase Slice Thickness 1 To aid viewing, increase the Slice Thickness using the slider 1 within 3x3 View and Single View. The views update accordingly and display greater image depth, similar to maximum intensity projection (MIP). Data Modification Any modification to the ROI, triggers the creation of a new nidus object. An existing 3D nidus object that is modified, is saved in a new plan with the same name. Software User Guide Rev. 1.0 Smartbrush Angio Ver

30 Using Smartbrush Angio Reviewing Results To verify your results you must consider the following: Review/compare with projective images Review CIP and Red-Blue images Slice thickness Always review and verify the ROI contouring result before proceeding. The vessel segmentation results should be reviewed and compared with the original images and 2D projections. Angio Planning Output When an angio plan is complete, the following output is saved as DICOM data after selecting Done: 3D objects (nidus and vessel segmentation) 2D CIP image series Fusions (2D projections with the 3D MR or CT volumes) Reloading Angio Planning Data When angio planning is complete, reloading the treatment plan skips the Fusion and ROI contouring steps. The existing result is displayed in the 3x3 View within Brush. The output can be used for further processing. 30 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

31 USING SMARTBRUSH ANGIO 2.7 Closing Smartbrush Angio How to Close Smartbrush Angio To leave your current session for any reason, proceed as follows: Steps 1. Before closing, finalize your current task by selecting Done. 2. Select Home. The Content Manager main screen opens. 3. Select Exit on the Content Manager main screen. 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. Software User Guide Rev. 1.0 Smartbrush Angio Ver

32 Closing Smartbrush Angio 32 Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

33 INDEX INDEX Numerics 3D rotate view A Angio Planning output...30 workflow...14 angiography visualization B Brush editing toolbar functions using Brush...27 D data modification ROI data disposal instructions... 6 E Erase F Functions fusion Reset Undo Fusion Vessel Complexity Vessel Visible Fusion adjustment functions...19 automatic fusion fusing images how to manually adjust manual alignment overview G general functions back data...21 home...21 next...21 H how to close Smartbrush Angio open Smartbrush Angio...14 remove images save use Brush use Smartbrush I image orientation...16 removal...16 image data requirements...16 M modifying data O output saving treatment plans P Pan R ROI CIP View...24 DSA View how to use ROI...22 view selection ROI Brush...22 ROI Erase...22 ROI views Rotate...26 S save on shutdown saving data on shutdown discard saving the nidus...28 treatment plans...30 unsaved changes Scroll select images patient...15 shutdown exit Slice Thickness Smartbrush...26 editing...27 using Smartbrush Smartbrush Angio general information...13 how to close...31 how to open...14 object creation workflow overview support... 5 Software User Guide Rev. 1.0 Smartbrush Angio Ver

34 INDEX U Undo...26 V vessel segmentation...16 viewing options 3x3 View CIP view... 29,30 Red-Blue view... 29,30 Single View...27 views 3D visualization functions play video W WEEE...6 Windowing...26 Z Zoom Software User Guide Rev. 1.0 Smartbrush Angio Ver. 1.0

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