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HeartKey Rhythm is intended for use by qualified healthcare professionals for analysing ECG data from adults. HeartKey Rhythm analyses a single ECG lead recorded from compatible devices used for arrhythmia diagnostics such as Holters, Extended Holters, ECG Patches, Event Recorders, or other similar devices when assessment of the rhythm is necessary. The HeartKey Rhythm application program interface (API) is intended to be integrated into other device software to provide the following capabilities: - ECG signal conditioning, - ECG signal quality assessment, - QRS beat detection, - Ventricular ectopic beat detection, - ECG rhythm analysis HeartKey Rhythm is not intended for use in life supporting, or sustaining systems, or real-time ECG monitors, or cardiac alarm devices, or OTC-use only devices. HeartKey Rhythm analysis results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

HeartKey Rhythm is intended to automatically analyse ECG data and provide ECG signal processing and assessment of cardiac arrhythmias. The software processes the following types of ambulatory ECGs: - Standard Holter: Lead I, II, III electrode configuration using gel electrodes e.g., Ag/AgCl, - Patch: Modified Lead II, Lead III, sternum using gel electrodes e.g., Ag/AgCl . HeartKey Rhythm is capable of analysing both continuous ECGs as well as event recorders. The device provides the following analysis: Feature | Description ------- | ----------- ECG Signal Processing Engine (SPE) | Signal Conditioning (SC): Reduce the noise artefact present in the input ECG signal for physician review of NSR, AF and VE beats. Beat Detector (BD): Detect the QRS complexes of the input ECG signal. Signal Quality (SQ): Identify and classify the ECG segments' signal quality from the input ECG signal. ECG Arrhythmia Analysis (AA) | Rhythm Analysis: Normal Sinus Rhythm, Atrial Fibrillation, Cardiac Pause, Tachycardia, Bradycardia, Inconclusive, Unreadable. Beat Analysis: Normal (N), Ventricular (V) Ectopic. Beat Clustering: Beat Cluster Template, Beat Cluster Count, QRS Location, Beat Classification, Heart Rate The Software Library may be integrated into ECG management systems, ECG analysis platforms or remote patient monitoring platforms. The filtered and enhanced ECG is not intended to be used by other automated analysis algorithms.