Preventicus Heartbeats. 1.10.2

The Preventicus Heartbeats medical device offers users the ability to monitor their heart rhythm using just their smartphone camera, providing results in approximately one minute. Regular utilization of this tool may assist in identifying cardiac arrhythmias, particularly atrial fibrillation.

It is important to note that Preventicus Heartbeats is exclusively available for individuals traveling within the EU, Great Britain, and Switzerland, and is not operational in the U.S., nor has it received FDA authorization.

Key features of Preventicus Heartbeats include:

• No additional devices required: The analysis of heart rhythm is conducted solely through the smartphone camera, allowing for convenience and accessibility at any time and place.
• Comprehensive support: After completing a measurement, users receive a thorough analysis that includes actionable recommendations. Abnormal results can be further evaluated by medical experts.
• Enhanced engagement: Users can benefit from personalized articles designed to promote heart health as part of their daily routine.

German health insurance companies provide added benefits through a complimentary screening program, which includes:

• Efficiency with accuracy: Measurement results are automatically assessed, with any abnormal findings being verified by a physician.
• Timely intervention: In cases where atrial fibrillation is confirmed, users are assured an appointment with a cardiologist within a two-week timeframe.
• Proactive measures: The program equips physicians with specialized ECG equipment for effective diagnosis.

For inquiries regarding coverage by health insurance providers, additional information can be found at: www.fingerzeigen.de

Intended use:

The objective of this app is to identify signs of cardiac arrhythmia, which encompasses:

• An irregular pulse with suspected atrial fibrillation
• Suspected other cardiac arrhythmias characterized by frequent irregular heartbeats
• Measurement of heart rate (including pulse and pulse rate), particularly in cases indicating rates that are excessively low or high

Important notes:

The results provided are classified as suspected diagnoses and should not be interpreted as definitive medical diagnoses. They do not substitute for professional consultation, diagnosis, or treatment by a healthcare provider. This app must not be employed for decision-making in situations perceived as life-threatening (e.g., heart attack).

For any questions regarding the app or the "RhythmusLeben" prevention programme, please contact us at:

• Phone: +49 (0) 36 41 / 55 98 45-1
• Email: [email protected]

Legal information:

The Preventicus Heartbeats app is a clinically validated Class IIa medical device certified by TÜV NORD CERT GmbH and complies with the essential requirements of Regulation (EU) 2017/745 and its national implementations. The quality management system of Preventicus GmbH is certified according to ISO 13485:2021, establishing the internationally recognized standards for medical device manufacturing quality management systems.