Instructions for Use

Product Description

Intended Use

Marina Health is intended to assist maritime personnel in assessing and documenting medical conditions at sea. The software guides users through predefined medical assessment protocols and assures completeness of documentation to support remote consultation with healthcare professionals. The software is intended solely to support healthcare professionals by providing documentation assistance and does not perform diagnoses, make treatment decisions, support clinical-decision support or replace professional medical judgement. The final responsibility always lies with the medical personnel.

Intended Medical Indication

Marina Health is intended for assessment and documentation of common non-life-threatening medical conditions encountered in maritime environments. All diagnostic and treatment decisions must be made by qualified healthcare professionals, as the software serves only as an assessment structuring and documentation tool.

Characterization of User Profile

Marina Health is intended for use by both patients (e.g. seafarers presenting with medical complaints) who answer structured questions about symptoms and medical history, and personnel (e.g. maritime medical officers) who are assisted through physical examination and vital signs assessment. Users require only basic technical proficiency with web browsers and mobile devices.

Characterization of Patient Population

Marina Health is designed to assist with the assessment of patients, particularly seafarers and maritime personnel, of all ages (adults) presenting with various apparently non-life-threatening medical conditions in maritime environments. The system is intended to be used regardless of patient gender, ethnicity, or pre-existing medical conditions.

Characterization of Use Environment Including Software / Hardware

Marina Health operates as a web-based application accessible on smartphones (iOS/Android), tablets, and laptop/desktop computers with modern web browsers, requiring internet connectivity and microphone access for voice recognition features. The typical use environment is onboard maritime vessels.

Exclusions

⚠️ The software is not intended to replace professional medical judgement and all diagnosis and treatment decisions. The final responsibility always lies with the medical personnel.

Safety Information

Contraindications

1. Use as the sole means of medical assessment without appropriate professional medical oversight
2. Management of emergency medical situations without concurrent activation of appropriate emergency medical services
3. Direct diagnosis or prescription of medications without professional medical input
4. Replacement for professional medical judgment when such is available
5. Emergency/life-threatening situations

Warning and Remaining Risks

⚠️ Medical officer must always review the documentation before sending it to the maritime physician.

Reporting a Serious Incident

If you want to report a serious incident which occurred with this medical device, then you can do so by contacting your national competent authority under the following contact information:

For users in other countries, contact your national competent authority for medical devices.

Language

Arabic, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Filipino, Finnish, French, German, Greek, Hindi, Hungarian, Indonesian, Italian, Japanese, Korean, Malay, Norwegian, Polish, Portuguese (Brazil), Portuguese, Romanian, Russian, Slovak, Spanish, Swedish, Tamil, Turkish, Ukrainian, Vietnamese

System Requirements

Hardware

Any computer, smartphone or tablet capable of running a web browser with minimum specs defined in this document.

Software

Marina works for both Android and iOS. Software works for following mobile phone browsers:

• Safari 18.5 and above
• Chrome 135.0.7049.83 and above
• Firefox 141.1 (58972) and above
• Ecosia 141.0.7390.70.12 and above

Marina works in Ubuntu, macOS and Windows. Software works for following web browsers on computer:

• Safari 18.6 and above
• Chrome 142.0.7444.59 and above
• Firefox 144.0.2 and above
• Edge 126.0.2592.61 and above

IT-security Measures

ℹ️ Software grants authorized access to customers after correct login and password has been entered. Computer firewall on the client side has to allow WebRTC traffic for uninterrupted operation.

Installation

No installation is required. Software is accessible through web browser.

Safety and Maintenance

The software's lifetime is established to be 3 years. This is what is expected to be the maximum time until the implementation of a significant change, by which the manufacturer is able to react to the relevant changes to the software device environment, such as SOUP changes, cybersecurity innovations, or the evolving technological or medical state of the art.

Software Updates

Marina Health operates as a web-based application with automatic server-side updates managed by the manufacturer.

Frontend Updates

Updates to the user interface and browser-based components are deployed automatically. Users access the latest version by refreshing their browser or visiting the application URL. No manual installation is required.

Backend Updates

Server-side updates (API services, medical processing algorithms, PDF generation) are deployed via Docker container replacement on the production server. Updates typically occur during scheduled maintenance windows (48-hour advance notice provided) and require no user action.

Update Notification

Users will be notified of significant updates via email and in-app notifications. Browser compatibility requirements will be communicated 90 days in advance if changes are required.

Reporting Malfunctions

Users should report software errors, system unavailability, or unexpected behavior to:

• Email: support@marinahealth.eu
• Phone: +45 53 86 19 85
• Response Time: Within 2 business days

Include: date/time, description of issue, steps to reproduce, screenshots, browser/device information, and impact on medical assessment.

Reporting Clinical Incidents

If the software may have contributed to patient harm, delayed treatment, or incorrect medical information, report immediately to:

• Email: regulatory@marinahealth.eu
• Phone: +45 53 86 19 85 (24/7)
• Response Time: Acknowledged within 24 hours

Users must also report serious incidents to their national competent authority as required by MDR 2017/745.

Lost Password and Account Access

For access issues, verify internet connectivity, browser compatibility, and contact technical support: support@marinahealth.eu

Reporting Security Breaches

If you suspect unauthorized access, data leak, or cybersecurity concerns:

• Stop using the system for sensitive patient data
• Report immediately: security@marinahealth.eu or +45 53 86 19 85 (24/7)
• Response Time: Acknowledged within 24 hours

Video Tutorial

For a complete visual walkthrough of Marina's features and workflow, watch our tutorial video:

Using the Software

Getting Started

1. Access Marina via web browser at the provided URL
2. Log in with your credentials (username and password)
3. Grant microphone permissions when prompted by your browser
4. You will arrive at the main dashboard

Configuring Your Session

Before starting a conversation, configure the following settings in the top panel:

Voice Input Mode:

• Continuous: For hands-free operation. Marina listens continuously.
• Push-to-Talk: Hold the space bar (keyboard) or microphone button (screen) while speaking.

Language Selection:

• Select the patient's language from the dropdown menu
• Select your language as the medical officer
• Marina will translate in real-time if the languages differ

Conducting a Medical Interview

1. Click the Play button to connect to Marina's AI assistant
2. Once connected, begin speaking naturally
3. Marina will guide you through a structured medical interview:
   • Chief complaint
   • Medical history
   • Current symptoms
   • Medications
   • Allergies
   • Vital signs
4. The conversation displays in real-time on screen:
   • Your speech appears on the right
   • Marina's responses appear on the left
5. If using push-to-talk mode, hold the space bar or microphone button while speaking

Generating the Medical Incident Report

1. When the interview is complete, click Prepare Report
2. Marina automatically analyzes the conversation and populates a 72-field medical incident form
3. The form follows the ABCDE structure (Airway, Breathing, Circulation, Disability, Exposure, Evaluation) ensuring systematic documentation
4. Auto-populated information includes:
   • Patient details
   • Medical history
   • Examination findings
   • Vital signs and Maritime Early Warning Score (M-EWS)
   • Medical officer's assessment
   • Relevant handbook reference notifications

Reviewing and Editing

1. Review each section of the form carefully
2. Click any field to edit directly — simply type to make corrections or additions
3. Verify all extracted information is accurate and complete

⚠️ The medical officer must review and approve all automatically extracted information before finalizing the report.

Finalizing the Report

1. When satisfied with the review, click Download PDF
2. Marina generates an official RMD-compliant maritime medical incident report
3. Save the PDF to your local device before closing the session

Automatic Saving and History

• Marina automatically saves your work every few seconds
• If you need to step away, your conversation will be waiting when you return
• Click the History button to access previous conversations. From the history, you can:
  • Review past cases
  • Continue an interrupted interview
  • Delete records you no longer need

Algorithm Description

Marina Health uses conversational AI (ElevenLabs) and large language models (Nebius AI) to:

• Extract structured medical data from natural language conversations
• Identify medical topics and suggest relevant handbook references
• Extract vital signs and calculate Maritime Early Warning Score (M-EWS)
• Translate conversations

⚠️ All algorithm outputs are displayed to the medical officer for review and approval. The system operates in supervised assistance mode with mandatory human review before any data is used or transmitted. No autonomous clinical decisions are made.

Alternative Devices and Services

If Marina Health is unavailable, users may use:

• Manual paper-based documentation (RMD forms, ship medical log)
• Generic note-taking applications (no medical structure or handbook integration)
• Direct telemedical consultation via phone/radio without structured documentation
• Physical medical handbooks (Ship Captain's Medical Guide, WHO International Medical Guide for Ships)

⚠️ Marina Health is designed to complement, not replace, professional medical judgment and standard maritime medical protocols.