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1. Introduction
1.1. Safety Analysis Overview
1.2. Safety of the Intended Function (SOTIF)
1.3. Cybersecurity Analysis
2. Installation and Configuration
2.1. Prerequisites
2.1.1. System Requirements
2.1.2. Licensing Considerations
2.1.3. Supported Third-Party Tools
2.2. Installing and Updating medini analyze
2.2.1. Uninstalling medini analyze
2.3. About Licensing
2.3.1. About the SAM Enterprise License
2.3.2. License Configuration
2.3.3. About License Servers
2.3.4. License Unavailability
2.3.5. License Borrowing
3. Getting Started with medini analyze
3.1. Starting the Application
3.1.1. Windows Start Menu
3.1.2. MPRX File
3.2. Application Structure and Views
3.2.1. Main Toolbar
3.2.2. Model Browser, Property View, and Editors
3.2.3. Perspectives
3.2.4. Preferences
3.3. Workspace Handling
3.4. Creating a Project
3.4.1. Managing Project Templates
3.4.2. Deriving a New Project from an Existing One
3.5. Deleting a Project from the Workspace
3.6. Renaming a Project
3.7. Opening and Closing Projects
3.8. Project Structure
4. Hazard Analysis and Risk Assessment
4.1. Creation of a new Analysis Model
4.2. Filling Hazard Analysis Tables
4.3. Views in the Hazard Analysis
4.4. Definition of Operational Situation Parameters
4.5. Analysis based on Operational Situation Catalogs
4.6. Using the Situation Matrix
4.6.1. Situation Matrix Configuration
4.6.2. Situation Matrix View
4.6.3. Situation Matrix Details
4.7. Creation of an Operational Situation Catalogs
4.8. Creation of pre-initialized hazard analyses
4.9. Import of an existing hazard analysis
4.10. Domain Specific Aspects of the Hazard Analysis
4.10.1. Hazard Analysis and Risk Assessment (Automotive)
4.10.2. Functional Hazard Assessment (Aerospace)
5. Safety Requirements Management
5.1. Safety Requirements Model
5.2. Graphical Editor for Safety Requirements
5.2.1. General
5.2.2. Element Creation and Modification
5.2.3. Relation Creation and Modification
5.2.4. ASIL Decomposition (ISO 26262)
5.3. Table Editors for Safety Goals and Safety Requirements
5.3.1. Safety Goal Table Editor
5.3.2. Requirements Table & Form Editors
5.4. Safety Requirement Allocation and Traceability
5.5. Requirements Renumbering
6. System Design Models
6.1. Creating a new SysML Model
6.2. Using the Graphical SysML Editor
6.2.1. Creating elements via the palette
6.2.2. Multiple Diagrams
6.2.3. Exchange Visual Appearance of Elements
6.3. Custom Table Views and Editor
6.3.1. Configuration of a Table View
6.4. SysML Blocks: Facilitating the type concept
6.4.1. Creating parts of an existing block type
6.4.2. Deriving a type from an existing part
6.4.3. Assigning, Removing, and Changing Types
6.4.4. Updating instances via their types
6.4.5. Using Feature Inheritance (Superclassing)
6.4.6. Port Definitions
6.4.7. Navigation between type and elements
6.5. SysML Activities and Actions
6.6. Specifying the Functions of a System
6.6.1. Functions in the diagram
6.7. Editing Properties of Model Elements
6.7.1. Property View for elements
6.7.2. General Element Properties
6.7.3. Safety Properties
6.7.4. Failure modes and Malfunctions
6.7.5. Failure Rates of elements
6.7.6. Limitations
6.7.7. Ports and Data Flow Specifications
6.7.8. Failure Mode Properties
6.7.9. Malfunctions
6.7.10. Element Dependencies
6.7.11. Copy of Failure Rate Data And Failure Modes
6.8. SysML Dependency Net Editor
6.8.1. Opening the Dependency Net Editor
6.8.2. Editing SysML Dependencies
6.9. SysML Reliability Table Editor
6.10. Cloning of complete SysML Models
6.11. Using Element Libraries
6.11.1. Creating an Element Library
6.11.2. Importing an Element Library
6.11.3. Updating an Element Library
6.12. Import of Element Lists from CSV/Excel
6.12.1. Updating Element Lists from CSV/Excel
6.13. Allocation and Traceability
6.14. Transition from SysML v1.x to SysML v2
7. Safety Analysis
7.1. Failure Mode and Effects Analysis (FMEA)
7.1.1. Setup of FMEA Risk Classification
7.1.2. FMEA Risk Matrix Definition
7.1.3. Creation of FMEA Worksheets
7.1.4. Executing the FMEA
7.1.5. FMEDA Option (Deprecated)
7.1.6. Import of FMEA data (Excel)
7.1.7. Copy and Paste for FMEA worksheets
7.2. System Weakness Analysis (SWA)
7.2.1. Creation of SWA Worksheets
7.2.2. SWA Worksheet Structure
7.3. Fault Tree Analysis (FTA)
7.3.1. Creation of FTA models
7.3.2. FTA Diagram Editor
7.3.3. FTA Diagram Pagination
7.3.4. Reoccurring Events
7.3.5. Laying Out a Fault Tree
7.3.6. Event and Gate Properties
7.3.7. Outline view
7.3.8. Creation of Events from Models
7.3.9. Importing FTA Models
7.3.10. Analysis of Fault Trees
7.3.11. Copy and Paste for FTA
7.3.12. Deriving safety requirements from FTA
7.3.13. Deriving failures from FTA
7.4. Component Fault Trees (CFT)
7.4.1. Creation of Fault Tree Components
7.4.2. Usage of Fault Tree Components
7.4.3. Handling of Probabilities in CFTs
7.4.4. Evaluation of CFTs
7.4.5. Generating fault trees from CFT
7.5. Reliability Block Diagrams (RBD)
7.5.1. Creation of RBD Diagrams
7.5.2. RBD Editor Concepts
7.5.3. RBD Evaluation
7.5.4. Conversion of RBD into FTA
7.6. FMEDA and Diagnostic Coverage Metrics
7.6.1. Creation of FMEDAs
7.6.2. FMEDA Worksheet Configuration
7.6.3. Usage of the FMEDA Worksheets
7.6.4. Safety Mechanism Coverage Analysis
7.6.5. Deactivation of Safety Mechanisms
7.6.6. Analyzing multiple Safety Goals
7.6.7. Analysis of Variants in FMEDA
7.6.8. SPF/LF for transient failures
7.6.9. Failure Modes - Causes and Effects
7.6.10. Copy and paste of FMEDA Worksheets
7.6.11. Copy analysis results in FMEDA Worksheets
7.6.12. Exporting an FMEDA Worksheet for configuration in an application context
7.7. HAZOP and Guideword Analysis
7.7.1. Guideword Template Definition
7.7.2. Creating a HAZOP or Guideword Analysis
7.7.3. Change Guideword Columns
7.8. Reliability Prediction
7.8.1. Failure Rate Handbooks
7.8.2. Reliability Databases
7.8.3. Component Failure Rates
7.8.4. Mission Profiles for Failure Rate Prediction
7.8.5. Transient Base Failure Rates
7.8.6. Adjusting the Unit of Failure Rates
7.8.7. Automation of Failure Rate Selection from Handbooks
7.9. Failure and Weakness Collections
7.9.1. Creating collections
7.9.2. Working with failure collections
7.9.3. Import into Collections
7.10. Measures and Design Controls
7.10.1. Working with Measures and Design Controls
7.10.2. Import of Measures/Mechanisms
7.10.3. Safety Mechanisms and Predefined Catalogs
7.11. Failure Rate Aggregation for Chip Design Analysis
7.12. Fault Injection Support for IP Design Analysis
7.12.1. Mapping failure modes and safety mechanisms to IP design models
7.12.2. Exporting Fault Injection Campaign Data
7.12.3. Updating Diagnostic Coverage values from fault injection runs
8. Safety Domain Profiles
8.1. Automotive (ISO 26262)
8.1.1. ISO 26262 Project Template
8.1.2. ASIL Assignment and Computation
8.1.3. Item Definition
8.1.4. HW Architectural Metrics (FMEDA)
8.2. Aerospace (ARP 4754A/ARP4761)
8.2.1. Aviation Project Template (ARP 4754A/ARP4761)
8.3. Industrial Profile (IEC 61508)
8.3.1. Industrial Project Template (IEC 61508)
8.4. Other Safety Standards
8.5. Cybersecurity Profile
8.5.1. Cybersecurity Project Template
8.5.2. Adding a Cybersecurity Domain Profile
9. Task Management & Commenting
9.1. Overview
9.2. Connection to Repositories
9.2.1. Repository Reconnection
9.2.2. Task Management with PTC Windchill RV&S (formerly Integrity)
9.3. Task Creation
9.4. Working with Tasks
9.4.1. Task to Element Navigation
9.4.2. Element to Task Navigation
9.4.3. Task Lists
9.4.4. Task Activation and Deactivation
9.4.5. Scheduling and other Properties of Tasks
9.4.6. Task lifecycle for deleted elements
9.5. Miscellaneous
9.5.1. Deletion of Task Associations
9.5.2. Export and Import of Task Lists
9.5.3. Submission of multiple Tasks
10. Checklists
10.1. Checklist Template Definition
10.2. Using Checklists
10.2.1. Using Checklist Headlines
10.3. Quick Edit Options
10.4. Duplicate a Checklist
11. Safety Planning and Management
11.1. Introduction
11.1.1. Safety Planning Overview
11.1.2. Ansys Digital Safety Manager
11.2. Team Management: Users, Roles, and Assignments
11.2.1. Define Groups and Users
11.2.2. Defining Roles and Assignments
11.3. Timeline and Milestones Management
11.3.1. Setting Project Timelines and Milestones
11.4. Safety Plan Organization
11.4.1. Creating a Safety Plan and Defining Activities
11.4.2. Specifying Work Products
12. Diff/Merge Handling
12.1. Overview of teamwork
12.1.1. 2-way vs. 3-way compare
12.1.2. Setup for teamwork
12.2. Comparison of projects
12.2.1. Configuring and starting project comparison
12.2.2. Differences perspective
12.3. Integrate and Merge
13. Real-Time Collaboration
13.1. Adding a Server
13.2. Opening a Project
13.3. Deleting a project from the server
13.4. Sharing a Project
13.5. Locking a Project for Editing
13.5.1. Starting Exclusive Editing
13.5.2. Stopping Exclusive Editing
13.5.3. Requesting Project Access
13.5.4. Unlocking a Locked Project
13.6. About Project Versions
13.6.1. Viewing a Version
13.7. Working Offline
13.7.1. Creating an Offline Project
13.7.2. Pushing Changes to the Server
13.7.3. Pulling Changes from the Server
13.7.4. Resolving Merge Conflicts
13.7.5. Deleting Offline Projects
14. Integrations
14.1. Exchange of Requirements with RMS
14.1.1. Common Integration Features
14.1.2. DOORS Integration
14.1.3. PTC Windchill RV&S Integration
14.1.4. Jama Integration
14.1.5. DOORS NG Integration
14.1.6. Polarion Integration
14.1.7. Codebeamer Integration
14.1.8. ReqIF based Requirements Exchange
14.1.9. Import and Export with Excel
14.2. MATLAB/Simulink Integration (Deprecated)
14.2.1. Connection to the MATLAB/Simulink Installation
14.2.2. Loading Simulink Models
14.2.3. Updating Simulink Models
14.2.4. Show details of imported Simulink models
14.3. Exchange with 3rd Party FTA Tools
14.3.1. Exchange with Reliability Workbench
14.3.2. Exchange with CAFTA
14.3.3. Exchange in OpenPSA Format
14.4. Exchange with 3rd Party FMEA Tools
14.4.1. Import of FMEA data (MSR-XML Format)
14.4.2. Export of FMEA data (MSR-XML Format)
14.5. Metadata of Imported Models
15. About SysML Model Integration
15.1. Importing Models from External SysML Tools
15.1.1. Concepts Supported During Import
15.1.2. About the Import of SysML Diagrams
15.2. Updating Imported SysML Models
15.2.1. Updating an Imported Model
15.3. Import from Ansys System Architecture Modeler (SAM)
15.3.1. Before you begin
15.3.2. Importing a Model from Ansys SAM
15.4. Import from IBM Rational Rhapsody
15.4.1. About Supported Versions
15.4.2. Before You Begin
15.4.3. Import Options for Rhapsody
15.4.4. Importing a Model from Rhapsody
15.4.5. Known Issues when Importing from Rhapsody
15.5. Import from Cameo Systems Modeler (MagicDraw)
15.5.1. Importing a Model from Cameo (MagicDraw)
15.6. Import from Sparx Systems Enterprise Architect
15.6.1. Importing a Model from EA
15.6.2. Importing Diagrams from Enterprise Architect
15.6.3. About Mappings in Enterprise Architect
15.6.4. About Constraints When Importing from EA
15.7. Import from SCADE Architect
15.7.1. Importing a Model from SCADE Architect
15.8. Import of Chip Design Data (IP Design)
15.8.1. Showing Details of Imported Models
16. Reporting and Document Generation
16.1. Table Reports
16.2. Standard Tool Reports
16.2.1. FTA Report (with auto-pagination)
16.2.2. FMEA Report
16.2.3. Automotive Reports (ISO 26262)
16.3. Generating an Overall Project Report
16.4. Generating a custom report
16.5. Using M2Doc to Generate a Report
16.5.1. Preparing the Report Configuration
16.5.2. Generating the Report
17. Common Features
17.1. Searching
17.2. Tagging Elements
17.3. Adding or Referencing Documents
17.3.1. Referencing to External Documents from Form Editors
17.4. Import and Export of Projects and Data
17.4.1. Export of projects using the Eclipse wizard
17.4.2. Import of projects using the Eclipse wizard
17.4.3. Import of Project Settings
17.4.4. Import of data in Excel/CSV-Format
17.5. Subversion and CMS Integrations
17.6. Element Relationships
17.7. Traceability
17.7.1. Creation of traces
17.7.2. Editing of Traces
17.7.3. Deletion of traces
17.7.4. Detection of dangling traces
17.7.5. Filtering the trace matrix
17.7.6. Predefined filters
17.7.7. Trace Matrix Report
17.7.8. Navigation via traces
17.8. Glossary
17.8.1. Creation of Glossary and Glossary Entries
17.8.2. Glossary Support in Forms
17.9. Dependency Viewer
17.9.1. Activation
17.9.2. Setting the focus
17.9.3. Dependency Viewer Options
17.9.4. Other options
17.10. Project states
17.11. Constraint validation
17.11.1. Project Validation
17.11.2. Definition and management of constraints
17.12. Profiling mechanism
17.12.1. Adding a new property
17.12.2. Text type properties
17.12.3. Reference type properties
17.12.4. Boolean type properties
17.12.5. Date type properties
17.12.6. Properties of type "derived"
17.13. Expressions Language
17.14. Project Settings
17.14.1. Auto-counter Patterns
17.14.2. Failure Rate Catalogs
17.15. Using the Model Browser
17.15.1. Drag and Drop
17.15.2. Management of package structure
17.15.3. View Menu
17.16. General aspects for table editors
17.16.1. Table Layout
17.16.2. Adding and manipulating rows and cells
17.16.3. Editing Reference Cells
17.16.4. Navigation in tables and data entry
17.16.5. Filtering Table Editors
17.16.6. Generating Reports
17.17. General aspects for graphical editors
17.17.1. Element creation
17.17.2. Copy, Paste and Element Deletion
17.17.3. Working with multiple diagrams
17.17.4. Changing the visual appearance of diagram elements
17.17.5. Referenced Elements
17.18. General aspects for form editors
17.18.1. Custom properties definition
17.19. Command Line Interface
17.19.1. Syntax
17.19.2. Compare Command
17.19.3. Open Command
17.20. Legend
17.21. Miscellaneous
18. Additional Information
18.1. Project migration after updating medini analyze
18.1.1. Migrating Shared Projects
18.1.2. Migration from 1.x and 2.x versions
18.1.3. Migration from v3.0 to v3.1
18.1.4. Migration from v3.1 to v3.2
18.1.5. Migration from v3.2 to v3.4
18.1.6. Migration from v3.4 to v4.0
18.1.7. Migration from v4.0, v18.0 and v18.1 to v18.2
18.1.8. Migration from v18.2 to v19.0
18.1.9. Migration from 19.x to 2019 R1
18.1.10. Migration from 2019 R1 to 2019 R2
18.1.11. Migration from 2019 R2 to 2019 R3
18.1.12. Migration from 2019 R3 to 2020 R1
18.1.13. Migration from 2020 R1 to 2020 R2
18.1.14. Migration from 2020 R2 to 2021 R1
18.1.15. Migration from 2021 R1 to 2021 R2
18.1.16. Migration from 2021 R2 to 2022 R1
18.1.17. Migration from 2022 R1 to 2022 R2
18.1.18. Migration from 2022 R2 to 2023 R1
18.1.19. Migration from 2023 R1 to 2023 R2
18.1.20. Migration from 2023 R2 to 2024 R1
18.1.21. Migration from 2024 R1 to 2024 R2
18.1.22. Migration from 2024 R2 to 2025 R1
18.2. Diagnostic Tools
18.3. Support for medini analyze
18.4. Reporting Defects and Problems
18.5. Out Of Memory
18.6. Deprecated Features
18.6.1. Generation of FTA from Simulink
18.6.2. Internal SVN Client
18.6.3. MATLAB/Simulink
18.7. Trademarks and copyright information