Electrocardiograph, Holter analyser, software

Intended purpose

Atrio Plus is designed to assist healthcare professionals in reviewing and interpreting ambulatory ECG recordings to identify arrhythmic events and support clinical decisions. It is not intended for real-time monitoring, emergency diagnostics, or paediatric applications. The ECG AI software developed by Alerte Digital Health serves as a medical device intended to assist medical practitioners or trained personnel working under their supervision and direction in the review and analysis of ECG readings. The software also enables reports to be generated. Diagnosis of cardiac conditions and decisions regarding treatment of patients is the responsibility of the medical practitioner. The Atrio Plus product is a combination of AI algorithms and diagnostic workbench tools. The ECG AI algorithm is designed to compliment the ECG diagnostic workbench and assist in the evaluation and management of various cardiac conditions and diseases. A summary of indications for using Atrio Plus include: Syncope, pre‑syncopal episodes, palpitations where episodes are occurring more than once a week, another asymptomatic arrhythmia is suspected with an expected frequency of greater than once a week and surveillance following cardiac surgical procedures that have an established risk of causing dysrhythmia. Atrio Plus has been tested to reliable detect: AF (Atrial Fibrillation), Bradycardia, Tachycardia, Atrial and Ventricular Couplets and Triplets, Atrial and Ventricular Late Beats, Atrial and Ventricular Runs, Atrial and Ventricular Bigeminy and Trigeminy, Premature Atrial and Ventricular Contractions, Pause, Ventricular Ectopic Beats, Interpolated Premature Ventricular Contractions, R on T Beat, Noise, Minimum Heart Rate, Maximum Heart Rate and Average Heart Rate. The automated analysis explicitly does not include ST segment, QT interval, or any other automated morphological analysis. Exclusions for Morphological Analysis: Does not include automated evaluation of ST segment, QT interval, or other morphological abnormalities; these require manual interpretation by qualified prefessionals. Declared Limitations: To ensure safe and appropriate use of the device: - Not indicated for use in patients under 18 years of age. - Not validated for rhythms influenced by pacemakers or defibrillators. - Not intended for acute care or hospital telemetry settings. - Not validated for detection of ST-elevation, ischemia, or myocardial infarction. - Not designed for arrhythmia diagnosis without clinician oversight. - AI outputs must be reviewed by trained users; override functionality is provided and required.