Cardiopulmonary physiological parameter analysis software, patient-use

Intended purpose

The device is a software-only medical device intended to analyse and filter electrocardiogram (ECG) signals acquired from compatible devices to detect atrial fibrillation (AFib) and classify heart rate. The device is intended for use by healthcare professionals and/or lay users. The data generated by the device is intended for informational use only. The lay user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The output data is meant to supplement rhythm classification for the purposes of discriminating AFib from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The device is not recommended for users with other known arrhythmias. The device is intended for use by an adult population. The accessories allow the display of output data from the analysis performed by the ECG library