Preventicus Nightwatch

Preventicus GmbH

About this app

Preventicus Nightwatch is an MDR-certified medical device for recording heart rate curves using a Polar Verity Sense wristband. It can be used to analyze both the heart rate (pulse) and the heart rhythm. Regular use supports the detection of sporadic cardiac arrhythmias, especially atrial fibrillation. If atrial fibrillation is diagnosed at an early stage, treatment - usually with medication - can almost equalize the otherwise high risk of stroke.
Please note that Preventicus Nightwatch can currently only be used as part of a study with a corresponding access code.

The range of functions and the supported wearables will be continuously expanded in the future and the app will be made available for use outside of studies.

Intended purpose
The app is used to detect cardiac arrhythmias in the form of a suspected diagnosis and to determine and characterize the heart rate. This concerns the following cardiac arrhythmias:
- Detection and quantification of absolute arrhythmia with suspected atrial fibrillation
- Detection of extrasystoles and irregular heartbeats
- Determination of the heart rate with indications of bradycardia and tachycardia.

Important notes
All results are suspected diagnoses, not a diagnosis in the medical sense. Suspected diagnoses do not replace personal consultation, diagnosis or treatment by a doctor.
This app must not be used to make decisions in situations that are perceived as life-threatening (e.g. heart attack).

We will be happy to help you with any questions about the app:
Phone: [phone]
E-mail: [e-mail]

Legal information
The Preventicus Nightwatch app is a clinically validated Class IIa medical device certified by TÜV NORD CERT GmbH and meets the essential requirements of Regulation (EU) 2017/745 and its national implementation. The quality management system of Preventicus GmbH is certified according to ISO 13485. This standard formulates and defines the internationally applicable requirements for quality management systems, particularly for medical device manufacturers.