CardioSignal

Gain information about your heart health in just one minute with your phone.

CardioSignal application is a reliable and easy-to-use CE marked (Class IIb) medical device. The intended purpose of the application is to detect signs of atrial fibrillation in adults (aged 18 years and older).

Why use CardioSignal:

Atrial fibrillation is the most common heart rhythm disorder, and it may present without symptoms. With regular monitoring, it can be detected and treated early. When left untreated, atrial fibrillation can expose to e.g. stroke and heart failure.

How it works:

The app is easy to use: Lie down and relax. In the app, press the start button and place your phone in the center of your chest. The measurement takes 60 seconds, after which you will get the result shortly. If after a ‘Repeat the measurement’ result you get a ‘Signs of atrial fibrillation’ result, contact your doctor or care provider. Visit https://cardiosignal.com/support for more information.

Our patented technology utilizes smartphones' motion sensors to detect signs of atrial fibrillation, and is based on a decade of academic research and algorithm development. The accuracy of the CardioSignal app is 94% to detect signs of atrial fibrillation.

Please note that the atrial fibrillation measurement requires a 1 month, 3 month or 1 year subscription. Creating a user account is required. For more information, please visit https://www.cardiosignal.com .

Contraindications (= when the device should not be used)

This application is intended for individuals aged 18 years and older. Do not use it on those aged under 18 years. The heart rate of children and adolescents can be significantly affected by their breathing rate and a normal heart rhythm might look irregular.

Do not use the application for individuals who have a cardiac pacemaker. A powered-on phone held close to a cardiac pacemaker can create electromagnetic interference (EMI), which may alter the function of the pacemaker.

Read more about Warnings and Precautions from Instructions for Use: https://cardiosignal.com/support

In case of a health emergency, contact emergency services.

Product information

Device Name: CardioSignal

Intended Purpose: to detect signs of atrial fibrillation in adults (aged 18 years and older)

Operating Requirements: Android operating system version 9 or above; The device must have motion sensors (accelerometer and gyroscope)

Electronic Instructions for Use (eIFU): https://cardiosignal.com/support

Unique Device Identification number (UDI-DI): (CardioSignal v3.1 Android): 06430081450069

Notified Body: Eurofins Electric & Electronics Finland Oy (0537)

Certificate Number: CR-03-1202-877-25

Manufacturer information

Manufacturer: Precordior Oy, Aurakatu 6, 20100 Turku, Finland.

Single registration Number: FI-MF-000014540

Authorized representatives

UK Responsible Person: Psephos Limited

Sussex Innovation Center, Science Park Square, Brighton, East Sussex BN1 9SB

United Kingdom

rep@psephos.com, +44 1273 704527

Manufacturer Representative, Republic of India: GenePath Diagnostics India Private Limited

Safire Park Galleria, Pune-Mumbai Road, Wakdewadi, Shivaji Nagar, Pune 411005

Maharashtra, India

contactus@genepathdx.com, +91 204 856 6661

CDSCO PRECOR-FIN/1/MD/006237

Swiss Authorised Representative: OMCS Medical GmbH. C/O Mr Wilhelm Gudelow

Aegeristrasse 5, 6300 Zug

AR@omcmedical.com