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/*

* SPDX-License-Identifier: AGPL-3.0-or-later

* SPDX-FileCopyrightText: Copyright 2026 Siemens Healthineers

*/

DAVE User Guide

Table of Contents

Getting Started

First Login

  1. Access the System

    • Open your web browser
    • Navigate to your DAVE URL (e.g., https://dave.yourorganization.com)
    • You'll see the login page

  2. Login Process

    • Enter your username (usually your email address)
    • Enter your password
    • If MFA is enabled, enter the 6-digit code from your authenticator app
    • Click "Login"

  3. Initial Setup

    • Complete your profile information
    • Set up notification preferences
    • Review and accept the terms of service

Dashboard Overview

The main dashboard provides a comprehensive overview of your organization's cybersecurity posture:

Key Metrics

  • Total Assets: Number of managed devices
  • Active Vulnerabilities: Current security issues
  • Open Recalls: FDA recalls affecting your devices
  • Compliance Rate: Overall compliance percentage

Navigation Menu

  • Dashboard: Main overview page
  • Assets: Device and asset management
  • Device Mapping: FDA device mapping
  • Recalls: FDA recall monitoring
  • Vulnerabilities: Security vulnerability management
  • Reports: Report generation and analytics

Asset Management

Adding Assets

Manual Entry

  1. Navigate to Assets → Add Asset
  2. Fill in the required information:
    • Basic Information
      • Hostname/IP Address
      • Asset Type
      • Manufacturer
      • Model Number
      • Serial Number
    • Network Information
      • IP Address
      • MAC Address
      • Network Segment
    • Organizational Data
      • Department
      • Location
      • Business Unit
      • Asset Owner
    • Criticality & Compliance
      • Criticality Level
      • Compliance Status
      • Security Classification
  3. Click Save Asset

Bulk Import

  1. Navigate to Assets → Upload Assets
  2. Prepare your CSV file with the following columns:
    • hostname, ip_address, manufacturer, model_number, serial_number
    • department, location, status, criticality_level
  3. Click Choose File and select your CSV
  4. Review the preview and click Import Assets

Managing Assets

Viewing Assets

  • List View: Tabular format with sorting and filtering
  • Grid View: Card-based layout for visual browsing
  • Search: Use the search bar to find specific assets
  • Filters: Filter by department, status, criticality, etc.

Editing Assets

  1. Click on an asset from the list
  2. Click Edit button
  3. Modify the required fields
  4. Click Save Changes

Asset Status Management

  • Active: Device is operational
  • Inactive: Device is offline or decommissioned
  • Maintenance: Device is under maintenance
  • Retired: Device has been decommissioned

Asset Categories

Medical Devices

  • Patient monitoring equipment
  • Diagnostic devices
  • Therapeutic devices
  • Laboratory equipment

IT Infrastructure

  • Servers and workstations
  • Network equipment
  • Storage systems
  • Security appliances

Device Mapping

FDA Device Mapping

The system automatically maps your assets to FDA device records for enhanced compliance monitoring.

Automatic Mapping

  1. MAC Address Lookup: System identifies manufacturer from MAC address
  2. FDA Database Query: Searches openFDA database for matching devices
  3. Confidence Scoring: Ranks potential matches by confidence level
  4. Manual Review: Review and confirm automatic matches

Manual Mapping

  1. Navigate to Device Mapping → Unmapped Assets
  2. Select an unmapped asset
  3. Search FDA database using device information
  4. Review potential matches
  5. Select the correct FDA device record
  6. Click Confirm Mapping

Mapping Status

  • Mapped: Asset successfully linked to FDA record
  • Unmapped: No FDA record found or mapping pending
  • Pending Review: Automatic mapping requires manual confirmation
  • Mapping Failed: Unable to find suitable FDA match

Device Information

FDA Device Data

  • Device Name: Official FDA device name
  • Manufacturer: Device manufacturer
  • Product Code: FDA product classification code
  • Device Class: FDA device class (I, II, or III)
  • Regulation Number: FDA regulation reference

Compliance Tracking

  • FDA Registration: Device registration status
  • Recall History: Past FDA recalls affecting this device
  • Vulnerability Status: Known security vulnerabilities
  • Compliance Score: Overall compliance rating

Vulnerability Management

SBOM Processing

Software Bill of Materials (SBOM) files provide detailed information about software components in your devices.

Uploading SBOM Files

  1. Navigate to Vulnerabilities → Upload SBOM
  2. Select the target device
  3. Choose your SBOM file (supports CycloneDX, SPDX, JSON, XML)
  4. Click Upload and Process

Supported SBOM Formats

  • CycloneDX: Industry-standard format
  • SPDX: Software Package Data Exchange format
  • JSON: Generic JSON format
  • XML: XML-based format

SBOM Processing

  • Component Extraction: Identifies all software components
  • Vulnerability Matching: Matches components to known vulnerabilities
  • Risk Assessment: Calculates risk scores for each component
  • Remediation Planning: Suggests remediation actions

Vulnerability Scanning

Automated Scanning

  • Scheduled Scans: Weekly vulnerability scans
  • Real-time Monitoring: Continuous vulnerability monitoring
  • NVD Integration: National Vulnerability Database integration
  • CVSS Scoring: Common Vulnerability Scoring System

Manual Scanning

  1. Navigate to Vulnerabilities → Scan Devices
  2. Select devices to scan
  3. Choose scan parameters
  4. Click Start Scan

Vulnerability Information

  • CVE ID: Common Vulnerabilities and Exposures identifier
  • Description: Detailed vulnerability description
  • Severity: Critical, High, Medium, Low, Info
  • CVSS Score: Numerical risk score (0.0-10.0)
  • Affected Components: Software components affected
  • Remediation: Suggested fixes and patches

Risk Assessment

Vulnerability Prioritization

  • Critical: Immediate attention required
  • High: Priority remediation needed
  • Medium: Address within reasonable timeframe
  • Low: Monitor and address when possible
  • Info: Informational only

Risk Factors

  • CVSS Score: Vulnerability severity
  • Exploitability: Ease of exploitation
  • Impact: Potential damage
  • Asset Criticality: Importance of affected device
  • Network Exposure: Network accessibility

Recall Management

FDA Recall Monitoring

The system automatically monitors FDA recalls and matches them to your devices.

Automatic Monitoring

  • Daily Checks: Automated daily recall monitoring
  • Real-time Alerts: Immediate notifications for new recalls
  • Device Matching: Automatic matching to affected devices
  • User Notifications: Email alerts to relevant users

Recall Information

  • FDA Recall Number: Official FDA recall identifier
  • Recall Date: Date recall was issued
  • Product Description: Detailed product information
  • Reason for Recall: Why the recall was issued
  • Manufacturer: Device manufacturer
  • Classification: Class I, II, or III recall
  • Affected Devices: Your devices affected by the recall

Recall Workflow

  1. Detection: System identifies new recall
  2. Matching: Matches recall to your devices
  3. Notification: Alerts relevant users
  4. Assessment: Review impact and required actions
  5. Remediation: Implement corrective actions
  6. Tracking: Monitor remediation progress
  7. Closure: Document resolution

Remediation Management

Remediation Status

  • Open: Recall requires action
  • In Progress: Remediation actions underway
  • Resolved: Recall has been addressed
  • Closed: No further action required

Remediation Actions

  • Device Replacement: Replace affected devices
  • Firmware Update: Update device firmware
  • Configuration Change: Modify device settings
  • Isolation: Remove device from network
  • Monitoring: Enhanced monitoring of affected devices

Documentation

  • Remediation Plan: Detailed action plan
  • Progress Updates: Regular status updates
  • Evidence Collection: Documentation of actions taken
  • Verification: Confirmation of successful remediation

Reporting

Report Generation

Available Reports

  • Asset Summary: Comprehensive asset overview
  • Vulnerability Report: Security vulnerability analysis
  • Recall Report: FDA recall status and impact
  • Compliance Report: Compliance status and issues
  • Device Mapping: Mapping status and gaps
  • Security Dashboard: Overall security posture

Generating Reports

  1. Navigate to Reports → Generate Report
  2. Select report type
  3. Choose export format (PDF, Excel, CSV)
  4. Set date range and filters
  5. Click Generate Report

Report Formats

  • PDF: Professional formatted reports
  • Excel: Spreadsheet format for analysis
  • CSV: Comma-separated values for data import
  • JSON: Machine-readable format

Analytics Dashboard

Key Metrics

  • Asset Statistics: Total, active, and new assets
  • Vulnerability Trends: Security issue trends over time
  • Recall Impact: Devices affected by recalls
  • Compliance Rates: Department compliance percentages

Department Analysis

  • Asset Distribution: Assets by department
  • Risk Assessment: Department risk levels
  • Compliance Status: Department compliance rates
  • Vulnerability Summary: Security issues by department

Trend Analysis

  • Historical Data: Trends over time
  • Seasonal Patterns: Recurring patterns
  • Risk Indicators: Early warning signs
  • Performance Metrics: System performance indicators

Scheduled Reports

Setting Up Scheduled Reports

  1. Navigate to Reports → Scheduled Reports
  2. Click Create Schedule
  3. Configure report parameters
  4. Set delivery schedule
  5. Add email recipients
  6. Click Save Schedule

Schedule Options

  • Daily: Daily report delivery
  • Weekly: Weekly summary reports
  • Monthly: Monthly comprehensive reports
  • Custom: Custom schedule configuration

User Management

User Roles

Administrator

  • Full system access
  • User management
  • System configuration
  • Background service management
  • Security management
  • API key management
  • Risk matrix configuration

User

  • Asset management
  • Device mapping
  • Vulnerability monitoring
  • Report generation
  • Dashboard access
  • Read-only system access

User Profile

Profile Information

  • Personal Details: Name, email, phone
  • Department: Organizational department
  • Role: User role and permissions
  • Preferences: Notification and display preferences

Notification Settings

  • Email Notifications: Email alert preferences
  • Dashboard Alerts: Dashboard notification settings
  • Report Delivery: Scheduled report preferences
  • Security Alerts: Security notification settings

Password Management

Password Requirements

  • Minimum 8 characters
  • Must contain uppercase and lowercase letters
  • Must contain numbers
  • Must contain special characters
  • Cannot reuse last 5 passwords

Password Reset

  1. Click Forgot Password on login page
  2. Enter your email address
  3. Check email for reset link
  4. Click reset link and enter new password
  5. Login with new password

Troubleshooting

Common Issues

Login Problems

  • Forgot Password: Use password reset function
  • Account Locked: Contact administrator
  • MFA Issues: Check authenticator app time sync
  • Browser Issues: Clear browser cache and cookies

Asset Management Issues

  • Upload Failures: Check file format and size
  • Missing Data: Verify required fields are filled
  • Permission Errors: Contact administrator for access
  • Search Issues: Try different search terms

Vulnerability Scanning Issues

  • Scan Failures: Check device connectivity
  • Missing Vulnerabilities: Verify SBOM upload
  • False Positives: Review vulnerability details
  • Update Issues: Check for system updates

Report Generation Issues

  • Report Failures: Check date ranges and filters
  • Missing Data: Verify data availability
  • Format Issues: Try different export formats
  • Download Problems: Check browser settings

Getting Help

Self-Service Resources

  • User Guide: This comprehensive guide
  • FAQ: Frequently asked questions
  • Video Tutorials: Step-by-step video guides
  • Knowledge Base: Searchable help articles

Contact Support

  • Email Support: support@yourorganization.com
  • Phone Support: (555) 123-4567
  • Ticket System: Submit support tickets
  • Live Chat: Real-time support during business hours

Training and Resources

  • User Training: Scheduled training sessions
  • Documentation: Comprehensive documentation
  • Best Practices: Recommended procedures
  • Updates: System update notifications

Last Updated: January 2024
Version: 1.0.0
For Technical Support: Contact your system administrator