Preventicus Nightwatch

Please note that the Preventicus Nightwatch app can currently only be used after it has been set up by a healthcare professional.

Intended Use

Preventicus Nightwatch is intended to detect cardiac arrhythmias by providing a suspected diagnosis, as well as to determine and characterize the heart rate. This applies to the following cardiac arrhythmias: detection and quantification of absolute arrhythmia with suspected atrial fibrillation, detection of extrasystoles and irregular heartbeats, and determination of heart rate with indications of bradycardia and tachycardia.

The result obtained is merely a possible suspicion (specifically, in the sense of the German Medical Association [DVG]: “suspected diagnosis”); it is not a diagnosis in the medical sense. The results are provided for informational purposes only and under no circumstances replace a personal diagnosis, consultation, care, or treatment by a physician or medically trained personnel.

The range of functions and supported wearables is continuously being expanded, and the app is being enhanced for various use cases.

Warnings

Warnings can be found in our instructions for use.

Link to the electronic instructions for use (eIFU)

https://www.preventicus.com/manuals-preventicus-nightwatch-app/

UDI-DI: (01) 409996600010 6

Important Notes

This app must not be used to make decisions in situations perceived as life-threatening (e.g., a heart attack).

We will be happy to help you with any questions about the app:

Phone: +49 (0) 36 41 / 55 98 45-2

E-mail: [email protected]

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 DIN EN ISO 13485:2021 / EN ISO 13485:2016 + AC:2018 + A11:2021. This standard formulates and defines the internationally applicable requirements for quality management systems for medical device manufacturers.

Manufacturer: Preventicus GmbH | Ernst-Abbe-Str. 15 | 07743 Jena (Germany)

SRN: DE-MF-000008931