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Preventicus GmbH

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Preventicus Heartbeats is a certified medical device for recording pulse waves at the fingertip via smartphone camera (photoplethysmography). This allows both the heart rate (pulse) and the heart rhythm to be analyzed. Regular use supports the detection of sporadic cardiac arrhythmias, especially atrial fibrillation. If atrial fibrillation is diagnosed at an early stage, therapy - usually with medication - can almost equalize the otherwise high risk of stroke.

Regular self-measurement of the heart rhythm, especially "atrial fibrillation screening", is recommended in the guidelines of the European Society of Cardiology (ESC) and the European Heart Rhythm Association and is particularly suitable for people with an increasing risk of stroke:
- generally from the age of 65
- from 55 years of age in the presence of other cardiovascular risk factors (e.g. high blood pressure, diabetes, after a stroke or heart attack, in case of felt palpitations)
- according to doctor's recommendation

The purpose of the app is to detect evidences (suspected or tentative diagnoses) of cardiac arrhythmias, in particular
- Extremely irregular pulse (absolute arrhythmia) with suspected atrial fibrillation
- Suspected other cardiac arrhythmias with frequent irregular heartbeats (e.g. ectopic heartbeats)
- Determination of the heart rate with indications or suspicion of bradycardia (pulse too low) or tachycardia (pulse too high), without their further diagnostic differentiation

All results are suspected (tentative) diagnoses of a digital medical device, not an actual diagnosis in the medical sense. Suspected (tentative) diagnoses are under no circumstances a substitute for personal consultation, diagnosis or treatment by a physician. This app may not be used to make decisions in situations that are considered life-threatening.

A major risk factor for stroke is untreated atrial fibrillation (AF). It is often unnoticeable and only occurs occasionally, making it difficult to detect in a doctor's office. Therefore, guidelines recommend regular self-checking of the heart rhythm. After medical diagnosis of AF, a (mostly drug-based) therapy can almost normalize the risk of stroke.

Use the free basic version to get to know the measuring process, determine your heart rate and get first hints if the app detects possible heart rhythm disturbances. The full version offers you additional features:
- a detailed analysis and presentation of the measurement results in ECG comparable manner
- saving and sharing measurements as an ECG-comparable PDF document
- a longer 5-minute measurement option, especially if recommended by a doctor, in order to be able to record less frequent arrhythmic events more probably
- optionally the possibility for ECG technicians of Telecare centers to perform an evaluation of the measurements to exclude possible measurement errors and to verify rhythm disturbances from a medical-technical point of view. Use this possibility especially after a doctor's recommendation, since a medical-technical pre-qualification of your measurements can considerably support the subsequent diagnostics of your doctor

Legal information:
The Preventicus Heartbeats application is a clinically validated Class IIa medical device certified by TÜV NORD CERT GmbH and meets the basic requirements of the 93/42/EEC Directive or its national implementations. The quality management system of Preventicus GmbH is certified according to ISO 13485:2016. This standard formulates and defines the internationally valid requirements for quality management systems, especially for medical device manufacturers.

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