Preventicus Heartbeats 1.10.0

Preventicus Heartbeats is a certified medical device designed for recording pulse waves at the fingertip using a smartphone camera through photoplethysmography. This technology enables the analysis of both heart rate and heart rhythm, supporting the detection of sporadic cardiac arrhythmias, particularly atrial fibrillation. Early diagnosis of atrial fibrillation can significantly reduce the high risk of stroke through timely intervention, usually with medication.

Regular self-monitoring of heart rhythm, specifically "atrial fibrillation screening," is recommended in the guidelines established by the European Society of Cardiology (ESC) and the European Heart Rhythm Association. This practice is particularly beneficial for individuals at an elevated risk of stroke:

• Individuals aged 65 and above
• Those aged 55 and over with other cardiovascular risk factors such as high blood pressure, diabetes, history of stroke or heart attack, or experiencing palpitations
• As advised by a healthcare professional

The primary objective of the application is to identify possible signs (suspected or provisional diagnoses) of cardiac arrhythmias, particularly:

• Highly irregular pulse (absolute arrhythmia) suggesting atrial fibrillation
• Suspected other cardiac arrhythmias characterized by frequent irregular heartbeats (e.g., ectopic heartbeats)
• Determining heart rate with indications or suspicion of bradycardia (low pulse) or tachycardia (high pulse) without detailed diagnostic differentiation

All results provided are considered suspected (tentative) diagnoses produced by a digital medical device and not definitive medical diagnoses. They are not intended to substitute personal consultation, diagnosis, or treatment by a qualified physician and should not be used to make decisions in life-threatening situations.

Untreated atrial fibrillation (AF) represents a significant risk factor for stroke. Oftentimes asymptomatic and sporadic, AF can be challenging to detect during regular medical visits. To mitigate this risk, guidelines recommend routine self-assessment of heart rhythm. Following a medical diagnosis of AF, appropriate therapy, primarily pharmaceutical-based, can substantially reduce the likelihood of stroke.

The free basic version allows users to familiarize themselves with the measurement process, determine heart rate, and receive initial suggestions if potential heart rhythm irregularities are detected. Upgrading to the full version unlocks additional features such as:

• Detailed analysis and presentation of measurement results in a manner similar to an electrocardiogram (ECG)
• Saving and sharing measurements as ECG-comparable PDF documents
• An extended 5-minute measurement option for capturing less frequent arrhythmic events more accurately, especially useful when recommended by a healthcare provider
• Opting for evaluation of measurements by ECG technicians from Telecare centers to identify possible measurement errors and assess rhythm disturbances with a medical-technical perspective. This option is particularly valuable post-doctor's recommendation as it can significantly aid your doctor in subsequent diagnostics.

Legal Information:

The Preventicus Heartbeats application is a clinically validated Class IIa medical device certified by TÜV NORD CERT GmbH, complying with the essential requirements outlined in Directive 93/42/EEC or its national implementations. Preventicus GmbH's quality management system is certified according to ISO 13485:2016 standards, which establish globally recognized quality management system requirements for medical device manufacturers.