QUENTRY FOR DBS QUENTRY - Version 3.1 - Software User Guide Revision 1.1 - Brainlab Online User Guides
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QUENTRY FOR DBS QUENTRY Version 3.1 Software User Guide Revision 1.1 Date of issue: 2020-12-29 (ISO 8601) Copyright 2020, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS TABLE OF CONTENTS 1 GENERAL INFORMATION.............................................................................................5 1.1 Contact Data ........................................................................................................................................5 1.2 Legal Information ...............................................................................................................................6 1.3 Symbols ................................................................................................................................................8 1.4 Using the System ...............................................................................................................................9 1.5 Compatibility with Software ...........................................................................................................10 1.6 Training and Documentation ........................................................................................................12 1.7 Technical Requirements .................................................................................................................13 2 QUENTRY for DBS .............................................................................................................15 2.1 Quentry for DBS................................................................................................................................15 2.2 Generating a Volumetric Map.........................................................................................................16 2.3 Viewing Clinical Data and Dashboards........................................................................................20 2.4 Brainlab Reference Model ..............................................................................................................22 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 3
TABLE OF CONTENTS 4 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
GENERAL INFORMATION 1 GENERAL INFORMATION 1.1 Contact Data Support If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: support@quentry.com Expected Service Life Brainlab provides five years of service for software applications. During this period of time, software updates as well as field support are offered. Feedback Despite careful review, this user guide may contain errors. Please contact us at user.guides@brainlab.com if you have improvement suggestions. Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 5
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 trademark of Brainlab AG. • Quentry® is a trademark of Brainlab AG. Non-Brainlab Trademarks • Microsoft®, Windows® and Internet Explorer® are registered trademarks of Microsoft Corporation in the US and other countries. Patent Information This product may be covered by one or more patents or pending patent applications. For details, see: www.brainlab.com/patent. Integrated Third-Party Software This software is based in part on the following work: • The Independent JPEG Group (https://github.com/uclouvain/openjpeg/blob/master/LICENSE). • The AWS SDK for .NET developed by Amazon.com, Inc. (https://aws.amazon.com/legal/) • The ClearCanvas SDK developed by ClearCanvas, Inc. (https://clearcanvas.github.io/) • The Log4Net developed by the Apache Software Foundation. (https://logging.apache.org/ log4net/) • The Microsoft .NET Framework SDK developed by Microsoft Corp. (https:// docs.microsoft.com/en-us/legal/termsofuse) • The Microsoft .NET Framework (WCF) developed by Microsoft Corp. (https:// docs.microsoft.com/en-us/legal/termsofuse) • The Microsoft DeepZoomTools developed by Microsoft Corp. (https://docs.microsoft.com/en-us/ legal/termsofuse) • The Microsoft DirectX SDK (February 2010) developed by Microsoft Corp.(https:// docs.microsoft.com/en-us/legal/termsofuse) • The Open DICOM developed by Albert Gnandt (https://sourceforge.net/projects/opendicom/). • The SharpZipLib (.NET) (https://github.com/icsharpcode/SharpZipLib). CE Label The CE label indicates that the Brainlab product complies with the essential re- quirements of Council Directive 93/42/EEC (the “MDD”). Quentry for DBS is a part of Quentry, which is a Class I product according to the rules established by the MDD. NOTE: The validity of the CE label can only be confirmed for products manufac- tured by Brainlab. 6 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
GENERAL INFORMATION Report Incidents Related to This Product You are required to report any serious incident that may have occurred related to this product to Brainlab, and if within Europe, to your corresponding national competent authority for medical devices. Sales in US US federal law restricts this device to sale by or on the order of a physician. No Medical Advice Neither Brainlab nor Quentry provide any medical advice. Customer is solely responsible for all medical decisions, including but not limited to the interpretation of any patient data, and any diagnosis, treatment or treatment plan made by the customer in connection with the use of Quentry. The customer acknowledges that image capture, image processing and image display also depend on the customer's specific computer hardware environment and corresponding system settings which are beyond reasonable control of Brainlab. Brainlab does not warrant that the image representation through Quentry will be free from any errors such as image distortions, color deviations or poor contrast and brightness values. It is the sole responsibility of the customer and any other user, physician or medical physicist involved to anticipate the possibility of such display errors in interpreting images visualized through Quentry. Security Quentry uses Amazon cloud infrastructure. All user-generated data is stored on servers that are located in secured facilities with 24/7/365 surveillance. The data centers are ISO 27001, SOC 1/ SSAE 16/ISAE 3402, and FISMA certified and accredited. The file data is stored within Amazon Web Services AWS (S3), a robust storage service designed for 99.999999999% durability. • Quentry user credentials, account data, and patient data are stored separately for increased security. • Advanced key management and access control systems ensure that Quentry patient data is accessible only to users who own the data. • All data transmitted is over TLS 128-Bit and stored 256-bit encryption. • Quentry meets both HIPAA and HITECH requirements for PHI (Protected Health Information), and is designed in accordance with European Union Data Protection Directives. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 7
Symbols 1.3 Symbols Warnings Warning Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with device use or misuse. Cautions Cautions are indicated by circular caution symbols. They contain important information regarding potential device malfunctions, device failure, damage to device or damage to property. Notes NOTE: Notes are formatted in italic type and indicate additional useful hints. Product Symbols Symbol Explanation Manufacturer Authorized representative in the European Community Consult instructions for use U.S. federal law restricts this device to sale by or on order of a physician Medical device 8 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
GENERAL INFORMATION 1.4 Using the System Intended Use and Indications for Use/Intended Purpose Quentry is indicated for image data transfer and online storage of medical images and related data. Quentry is a web based software for medical professionals that: • Supports users to build a global clinical network • Provides an online community to work in virtual groups • Provides users with tools for secure online image (DICOM) storage, review, transfer and sharing • Provides users with tools for aggregation and graphical visualization of patient data collected within Quentry It is not intended for primary diagnosis, detailed treatment planning or treatment of patients. Quentry does not have any specific indications for use. Intended Patient Population Quentry does not target any specific patient population. Intended User(s) and Conditions The device is generally used by medical professionals and medical organization support staff such as doctors, their assistants or nursing staff, within a hospital, a clinic, a doctor's office, or from remote locations, such as at home. Intended Use Environment Quentry is a pure web application that is accessible from any computer with internet connection. Plausibility Review Warning Before patient treatment, review the plausibility of all information input to and output from the system. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 9
Compatibility with Software 1.5 Compatibility with Software Compatible Brainlab Medical Software Quentry for DBS is compatible with the following Brainlab medical software: Brainlab Medical Software Comment Origin Data Manager Patient data management software. Used for viewing DICOM images and Brainlab treat- Viewer ment plans and comparing image sets. Guide XT Used for creating SFM Segmentation. Brainlab Elements Fibertracking Used to create fiber tracts. Brainlab Elements Trajectory Planning Used to create trajectories. Other compatible Brainlab software may become available after the release of this user guide. If you have questions regarding compatibility of software with Quentry for DBS contact Brainlab support. Warning Only Brainlab medical software specified by Brainlab may be installed and used with the system. Non-Brainlab Software Only authorized Brainlab employees may install software on the Brainlab system. Do not install or remove any software applications. Updates Warning Updates to the operating system (hotfixes) or third-party software should be performed outside clinical hours and in a test environment to verify correct operation of the Brainlab system. Brainlab monitors the released Windows hotfixes and will know, for some updates, if problems can be expected. Contact Brainlab support if any problems to operating system hotfixes are encountered. NOTE: This only applies to workstations or servers with the Cranial Contouring workflow or Quentry Gateway installed. Virus Scanning and Malware Brainlab recommends protecting the system with state-of-the-art anti-virus software. Be aware that some malware protection software (e.g., virus scanner) settings can negatively affect system performance. For example, if real-time scans are performed and each file access is monitored, then loading and saving patient data may be slow. Brainlab recommends disabling real-time scans and performing virus scans during non-clinical hours. Warning Ensure that your anti-virus software does not modify any Brainlab directories, specifically: • C:\Brainlab, D:\Brainlab, F:\Brainlab, etc. • C:\PatientData, D:\PatientData, F:\PatientData, etc. Warning Do not download or install updates during treatment planning. 10 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
GENERAL INFORMATION Contact Brainlab support for further information regarding any of these issues. NOTE: This only applies to workstations or servers with the Cranial Contouring workflow or Quentry Gateway installed. Microsoft Security Updates for Windows and Driver Updates Brainlab allows the installation of security patches only. Do not install service packs and optional updates. Verify your settings to ensure updates are downloaded and installed correctly and at a suitable time. Do not update drivers on Brainlab platforms. See the Brainlab website for more information about settings and a list of Microsoft Security Updates blocked by Brainlab support. Address: www.brainlab.com/updates Password: WindowsUpdates!89 NOTE: This only applies to workstations or servers with the Cranial Contouring workflow or Quentry Gateway installed. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 11
Training and Documentation 1.6 Training and Documentation Responsibility Warning This system solely provides assistance to the healthcare professional and does not substitute or replace the healthcare professional's experience and/or responsibility during its use. It must always be possible for the user to proceed without the assistance of the system. Only trained medical personnel may operate system components and accessory instrumentation. Reading User Guides This guide describes complex medical software or medical devices that must be used with care. It is therefore important that all users of the system, instrument or software: • Read this guide carefully before handling the equipment • Have access to this guide at all times Intended Audience Quentry.com is aimed at medical professionals (physicians, their staff, nurses, etc.) with sufficient understanding of the English technical vocabulary related to the fields of medical physics and medical imaging so as to enable appropriate understanding of the Quentry.com user interface. Available User Guides User Guide Contents Origin Data Manager Soft- Detailed software instructions on Content Manager and Patient ware User Guide Selection. Quentry.com Software Detailed software instructions on Quentry.com. User Guide Viewer Software User Detailed software instructions on Viewer. Guide Fibertracking Software Detailed software instructions on Fibertracking. User Guide Trajectory Planning Soft- Detailed software instructions on Trajectory Planning. ware User Guide 12 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
GENERAL INFORMATION 1.7 Technical Requirements Quentry Refer to the Quentry.com and Quentry Gateway Software User Guides. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 13
Technical Requirements 14 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
QUENTRY FOR DBS 2 QUENTRY FOR DBS 2.1 Quentry for DBS General Information Quentry for DBS is a licensed feature of Quentry that allows users to: • Upload and collect clinical data • Generate volumetric maps by aggregating regions of interest from patient image data • View graphical representations of clinical data and create your own dashboard Data Requirements and Preparation Each data set uploaded to Quentry for DBS must contain: • At least one Object (DICOM Segmentation Object (e.g., a Stimulation Field Model - SFM)) exported as Object • At least one image data (modality MRI) associated with the DICOM Segmentation Object (T1 or T2 in standard clinical resolution) • If the image data associated with the DICOM Segmentation Object is modality CT, a fusion with MRI must be provided Quentry for DBS Workflow Step 1. In Origin Data Manager, create DICOM segmentation objects and create meta informa- tion for these objects. 2. Upload image data and object meta information. 3. Filter objects with the uploaded meta info. 4. Generate a map. 5. View processing results. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 15
Generating a Volumetric Map 2.2 Generating a Volumetric Map General Information You can generate volumetric maps by aggregating regions of interest from patient image data. Maps can be constructed from the following DICOM segmentation objects: You can upload a 3D object of an SFM from Stimulation field model (SFM) Guide XT. You can upload a 3D object of a trajectory from Trajectory the Brainlab Element Trajectory Planning. You can upload a 3D object of a fiber bundle Fiber tract from the Brainlab Element Fibertracking. How to Create a Stimulation Field Model Step 1. Open Brainlab Origin Data Manager. 2. Select patient. 3. Select DBS Workflow. 4. Select postoperative data sets that include detected electrodes. NOTE: Ensure that an MR data set is always included. 5. Open GUIDE XT. 6. Create SFM. 7. Prepare DBS data for Quentry. For more information, refer to the Guide XT Software User Guide. How to Create a Trajectory Object Step 1. Open Brainlab Origin Data Manager. 2. Select patient. 3. Select Trajectory. 4. Choose a trajectory and export it. 5. In Origin Data Manager, export the object to Quentry for DBS. For more information, refer to the Trajectory Planning Software User Guide. How to Create a Fiber Tract Object Step 1. Open Brainlab Origin Data Manager. 2. Select patient. 16 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
QUENTRY FOR DBS Step 3. Select Fibertracking. 4. Choose a fiber bundle, and convert it to a 3D object. 5. In Origin Data Manager, export the object to Quentry for DBS. For more information, refer to the Fibertracking Software User Guide. How to Upload Image Data and PATIENT FORM - DBS Step 1. In Content Manager, select Export. 2. Any data sets you have selected are displayed. 3. Select Quentry as export destination. NOTE: PATIENT FORM - DBS is not displayed. How to Create a Map Step 1. In Quentry for DBS, select MAPS in Analytics. 2. Select New Map. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 17
Generating a Volumetric Map Step 3. Choose the type of map to create under SELECT MAP TYPE. 4. Select the filters you wish to apply to your map. 5. Enter a name for your map under Map Name. 6. Choose a color scheme under Colors. 7. Optional: enter a comment under Comments. 8. Select Save to create your map. Using Maps In Quentry for DBS, select MAPS in Analytics. Available maps are displayed. ① ② ③ ④ ⑤ ⑥ Figure 1 No. Component ① Map name ② Date created ③ Username 18 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
QUENTRY FOR DBS No. Component ④ Number of patients and objects included in map ⑤ Map type ⑥ Comment: Icons show filters used in map Options Icon Function To create a new map, select New Map. To clone an existing map, select Clone Map. To view a map, select View Map. To download the PDF report generat- select View Report. ed with the map, To download the map in order to use it in Origin Data Manager and Ele- select Download. ments (e.g., Guide XT), To delete a map, select Delete. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 19
Viewing Clinical Data and Dashboards 2.3 Viewing Clinical Data and Dashboards General Information You can view graphical representations of clinical data and create your own dashboard. How to View Graphical Data on the Dashboard Step 1. Select DASHBOARD from Analytics. 2. Any graphs or charts pinned to DASHBOARD are displayed. NOTE: Until you pin a graph, DASHBOARD remains empty. How to Create Dashboard Graphs from Clinical Data Step 1. To create a graph, select either POPULATION or TREATMENT from Analytics. 2. Select one of the topics from the drop-down menu (e.g., Patient Accrual under POPU- LATION). 3. Using the buttons in the upper right corner, select a chart type (e.g., line-chart or col- umn-chart). The graph is displayed. 20 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
QUENTRY FOR DBS Step 4. Edit the FILTERS options to limit information about the clinical data represented in a graph. Select APPLY when you are finished. NOTE: If you do not specify the CareTeam, the graph is generated based on data from all CareTeams of which you are a member. 5. To pin the graph so that it displays on your DASHBOARD, select the pin icon. Provide a name for the graph in SAVE TO DASHBOARD and select OK. NOTE: The pinned graph information shows the filters applied. NOTE: You can create and pin multiple graphs about the same topic using different filters. NOTE: If you make changes to a pinned graph later, it remains pinned. NOTE: To remove a pinned graph, select the x in the upper right-hand corner. Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 21
Brainlab Reference Model 2.4 Brainlab Reference Model General information The Brainlab Reference Model is an artificial patient used to superimpose probability maps onto a reference brain anatomy. The result of each processing session is stored in the Brainlab Reference Model in separate folders. After processing, you can review: • 1 artificial T1 MRI • 1 artificial T2 MRI • 1 artificial SWI MRI • 1 probability map • 1 aggregation report (.pdf) • 20 Brainlab atlas objects: - Capsula Interna Left - Capsula Interna Right - Caudatus Left - Caudatus Right - Globus Pallidus External Left - Globus Pallidus External Right - Globus Pallidus Internal Left - Globus Pallidus Internal Right - Nucleus Ruber Left - Nucleus Ruber Right - Putamen Left - Putamen Right - Substantia Nigra Left - Substantia Nigra Right - Subthalamic Nucleus Left - Subthalamic Nucleus Right - Thalamus Left - Thalamus Right - Ventral Intermediate Nucleus Left - Ventral Intermediate Nucleus Right 22 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1
INDEX INDEX B Brainlab Reference Model..........................................................22 C colors..........................................................................................18 compatible Brainlab medical software........................................10 Content Manager export.............................................................17 D dashboard.................................................................................. 20 DBS data.................................................................................... 16 downloading map....................................................................... 19 F filters...........................................................................................18 G graphs........................................................................................ 20 Guide XT.................................................................................... 16 M maps...........................................................................................17 O Origin Data Manager.................................................................. 16 P pin graphs...................................................................................21 population...................................................................................20 S SFM............................................................................................16 support......................................................................................... 5 T treatment.................................................................................... 20 W workflow..................................................................................... 15 Software User Guide Rev. 1.1 Quentry for DBS Ver. 3.1 23
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