Cardiac electrophysiology application software

Intended purpose

The device is a software-only device intended for use with the dedicated hardware to create, record, store, transfer and display lead-II and lead-III of a two-channel electrocardiogram (ECG). It derives and displays leads I, aVR, aVF and aVL. The device determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (no signs of AFib but a sinus rhythm with heart rate between 100-150 bpm) on a classifiable waveform. The device is not recommended for users with other known arrhythmias. The device is intended for over-the-counter (OTC) use. The ECG data displayed by the device is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform 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 intended for use by an adult population.