Electrocardiograph, Holter analyser, software

Intended purpose

A stand-alone software medical device intended to analyze in a computerized way continuous ECG recordings, visualize, review and edit the analysis and generate clinical reports. It intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. It is a tool to support the clinician in the interpretation of the ECG data and the diagnosis of heart rhythm disorders in adult and pediatric patients. It does not carry out an automated interpretation and is not intended as the only diagnostic tool.