Instructions for Use (IFU)

This electronic version is available in English and German. A paper copy is provided free of charge within seven calendar days on request at regulatory@synduct.com.

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1. Device Identification

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2. Intended Purpose

DR. INFO is intended to be used by healthcare professionals as a clinical reference and knowledge-support tool for supporting the practice of evidence-based medicine.

DR. INFO is designed as a clinical information and education platform for healthcare professionals, such as physicians, pharmacists, nurses and clinical researchers. It retrieves, displays, summarizes, and organizes authoritative sources such as medical guidelines, consensus statements, peer-reviewed literature, and public drug databases.

DR. INFO supports healthcare professionals in the process of clinical decision-making by providing access to and structured presentation of current, evidence-based medical information, such as guideline-recommended diagnostic and treatment pathways, for use in clinical practice. It retrieves EMA SmPC data for EU-approved medicines (e.g., indications, dosing, warnings) to assist clinicians in reviewing authorised product information relevant to patient management. It can generate source-referenced clinical visuals (e.g., hypertension management flow-chart) to aid patient education by the healthcare professional and interrogate specific documents (guidelines, SmPCs, consensus statements) at paragraph level with citation-anchored answers.

DR. INFO does not and may not be used to analyse personal health data of patients, rank or prioritize treatment options, provide diagnostic or therapeutic recommendations, calculate doses, or present outputs as action guidance at the point of care. All outputs are informational in nature and intended solely to assist qualified healthcare professionals in exercising their own clinical judgment.

Core Features:

• AI Summary: Users can ask medical queries and receive AI-generated summaries sourced from verified, referenced medical literature and databases
• Drug Search: Search and retrieve drug information from EMA SmPC and FDA drug reference databases
• Guideline Search: Search and access clinical guidelines from recognised international bodies (AHA, ACC, ESC, NICE, ADA, and others)
• Visual Abstract Generation: Generate visual abstracts (graphical summaries) from AI summary answers and medical text for educational and reference purposes

Data Sources:

• European Medicines Agency (EMA) Summary of Product Characteristics (SmPC)
• U.S. Food and Drug Administration (FDA) drug reference databases
• Published clinical guidelines from recognised international bodies
• Peer-reviewed consensus statements and medical literature

All AI-generated summaries and visual abstracts are sourced from the above verified references and must be independently reviewed by the healthcare professional before use.

Intended Users: Healthcare professionals, such as physicians, pharmacists, nurses and clinical researchers, who are qualified and licensed in their respective disciplines.

Intended Use Environment: Clinical, hospital, research, and professional healthcare settings. Accessible via web browser on desktop or mobile device, and via the native DR. INFO iOS application on iPhone and iPad. The intended purpose and informational scope are identical on both clients.

Clinical Benefits: The benefit of DR. INFO for patients is indirect, through the healthcare professional who uses the information: faster access to current, referenced guideline, literature and EU product information when a clinical question arises, and a citation for every statement so that the professional can check its source. DR. INFO does not claim to improve patient outcomes, diagnostic accuracy or treatment effectiveness.

Performance Characteristics: Answers are generated from retrieved sources, with a citation for each statement, and are normally available within 60 seconds.

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3. Contraindications and Limitations of Use

IMPORTANT — PLEASE READ CAREFULLY

DR. INFO is not intended to:

• Replace clinical judgment or professional medical advice
• Serve as the sole basis for a clinical decision or replace the healthcare professional’s independent clinical judgment
• Diagnose, treat, cure, or prevent any disease or medical condition
• Generate, recommend, or rank therapeutic or diagnostic options
• Process, analyse, or access individual patient health data or medical records
• Perform dose calculations or prescribe medication

DR. INFO supports healthcare professionals through referenced information. All clinical decisions remain the responsibility of the qualified healthcare professional. Do not enter patient data.

The information displayed by DR. INFO is sourced from verified, authoritative references. However, medical knowledge evolves and information should always be cross-referenced with current clinical practice guidelines, institutional protocols, and up-to-date prescribing information when reviewing the material for reference or education.

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4. Safety Information

4.1 General Safety Warnings

• Not a diagnostic tool: DR. INFO does not diagnose conditions and must not be used as a diagnostic instrument.
• Not a prescribing tool: Drug information displayed (including dosing, contraindications, and interactions) is derived from source documents for reference purposes only. Prescribing decisions must be made by a licensed prescriber in accordance with applicable laws and clinical assessment.
• Check the original reference: Compare displayed information with the current original source for accuracy and currency. Use the information only as a reference to support independent professional clinical judgment; it must not replace that judgment.
• Emergency situations: DR. INFO is not designed or intended for use in emergency clinical situations where immediate decision-making is required.

4.2 Data Privacy

DR. INFO does not collect, process, store or use patient data. Users must not enter patient data, including patient details without identifiers. Queries concern medical knowledge and referenced information for professional clinical judgment and education; individual patient data must not be entered.

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5. System Requirements

5.1 Minimum Technical Requirements

5.2 Supported Operating Systems

• Windows 10 / 11
• macOS 11 (Big Sur) and later
• iOS 15 and later (mobile browser)
• Android 12 and later (mobile browser)

5.3 Native iOS Application

The DR. INFO iOS application is a native client delivering the same informational features as the web application.

Device permissions requested by the iOS app (each optional and used only for the stated feature):

• Microphone — used only when the user starts a voice search, to capture the spoken query. Voice search is for general medical queries; as with typed queries, users must not dictate any patient data, including de-identified patient information (see §4.2). The recorded audio is sent to Google Gemini for transcription into text and is discarded after transcription; the user is informed and asked for consent before first use.
• Photo library — used only to attach general reference material to a query and to save generated visual abstracts to the device, at the user's request. Patient images, patient documents and all other patient data are prohibited.

DR. INFO is not intended for the collection, processing, storage or use of patient data on either client. Users must not enter patient data, including de-identified records, images or dictated information. Account and technical usage data are processed as described in the privacy policy.

5.4 Accessibility

Users with accessibility requirements can contact support (info@synduct.com) for assistance.

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6. Getting Started

6.1 Account Registration

Web application:

1. Navigate to drinfo.ai
2. Select Register and complete the professional registration form
3. State your profession (access is restricted to healthcare professionals)
4. Verify your email address
5. Log in with your credentials

Native iOS application:

1. Install DR. INFO from the Apple App Store
2. Open the app and select Register, or sign in with an existing account (email/password or Apple Sign-In)
3. Complete the professional registration form and verify your email address
4. Log in with your credentials

The same account is used across the web and iOS clients.

6.2 Authentication

DR. INFO uses secure authentication (Firebase Authentication). Users are responsible for maintaining the confidentiality of their login credentials.

6.3 Session Management

Sessions automatically expire after a period of inactivity. Users will receive a timeout warning before automatic logout. Always log out when leaving a shared device.

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7. Core Features

7.1 EMA SmPC Search

Retrieve official Summary of Product Characteristics for EU-approved medicines. All SmPC data is sourced directly from the EMA database. Information includes indications, dosing, contraindications, warnings, interactions, and adverse effects as published by the EMA.

How to use: Enter a medicine name or active substance in the search bar and select "SmPC" as the content type.

7.2 Clinical Guideline Viewer

Access structured summaries and full-text views of clinical practice guidelines from international authorities. Each guideline entry displays the source organisation, publication date, and version.

How to use: Search by condition, specialty, or guideline name. Filter by issuing body or publication year.

7.3 Literature and Consensus Statements

Access peer-reviewed literature summaries and consensus statements. All content is source-referenced with citations.

How to use: Use the literature search function with keywords, condition names, or drug names.

7.4 Document Query (Citation-Anchored)

Submit a specific question about a loaded document (SmPC, guideline, or consensus statement). DR. INFO retrieves and displays the relevant passage with a direct citation anchor to the source paragraph.

Important: Answers are generated from, and cite, the retrieved source passages. Always verify each answer against the cited source before relying on it.

7.5 Visual Reference Generation

Generate structured visual summaries (flowcharts, tables, comparison views) from guideline or SmPC content for educational and professional reference purposes.

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8. Understanding Information Displayed

8.1 Source Attribution

All information displayed by DR. INFO carries a source label indicating:

• The originating authority (e.g., EMA, FDA, ESC, NICE)
• The document title and version
• The publication or last-updated date

Users should always note the source date and verify that the information is current for their clinical context.

8.2 Disclaimer

All outputs of DR. INFO are informational. They support, but do not replace, independent professional clinical judgment. Do not enter patient data, and do not use DR. INFO for the functions excluded in section 3.

8.3 Reporting Accuracy Concerns

Users who identify an accuracy concern are encouraged to report it via the in-app feedback mechanism or by contacting support directly.

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9. Reporting Issues and Feedback

Users are encouraged to report any concerns, errors, or feedback through the following channels:

Response time targets:

• Safety concerns: Acknowledged within 24 hours
• Accuracy issues: Investigated within 5 business days
• Technical issues: Acknowledged within 2 business days

Any concern that may relate to patient safety will be treated as a potential serious incident and assessed in accordance with EU MDR 2017/745 Article 87 requirements.

Reporting serious incidents: Any serious incident that has occurred in relation to DR. INFO should be reported to Synduct GmbH (regulatory@synduct.com) and to the competent authority of the Member State in which the user and/or patient is established (in Germany: the Federal Institute for Drugs and Medical Devices, BfArM).

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10. Updates and Versioning

DR. INFO is updated continuously. Users will be notified of significant updates via in-app notification. Security updates are released according to their risk.

Synduct GmbH maintains a version history and release notes; they are available on request at regulatory@synduct.com.

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11. Data Privacy and GDPR

DR. INFO is operated in compliance with EU GDPR 2016/679. Users have the right to:

• Access their personal data held by Synduct GmbH
• Request correction of inaccurate data
• Request deletion of their account and associated data
• Lodge a complaint with their national data protection authority

Full privacy policy: drinfo.ai/privacy-policy

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12. Contact and Support

Manufacturer: Synduct GmbH, Bergmannstr. 58, 80339 Munich, Germany

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13. Symbols and Labelling

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14. Document Control

Document Version History

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These Instructions for Use are provided in accordance with EU MDR 2017/745 Annex I, Chapter III. This document is the property of Synduct GmbH.