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The AI-ECG Tracker is intended to be used by qualified healthcare professionals in hospitals and healthcare facilities for the assessment of arrhythmias using ECG data acquired from adults (age 22 and older) without pacemakers. The product supports downloading and analyzing data recorded from electrodes with conductive paste/gel placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary. The AI-ECG Tracker provides ECG signal processing and analysis on a beat by beat basis, QRS detection, Supraventricular Ectopic Beat detection, QRS feature extraction, interval measurement, and rhythm analysis. The AI-ECG Tracker is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. The AI-ECG Tracker interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

The AI-ECG Tracker is a distributed ECG auto analysis system designed to assist physicians and qualified healthcare professionals in measuring and interpreting ambulatory ECG data. The interpretations by the analysis program can be confirmed, edited, modified, or deleted by the physician and qualified healthcare professionals. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessments of common cardiac arrhythmias using ECG data acquired from adults (age 22 and older) without pacemakers. The AI-ECG Tracker receives ECG waveform data uploaded by a user, analyzes ECG data and automatically interprets on a computer server. The ECG measurement, interpretation and waveform data are then downloaded to the Physician Diagnostic Client for a physician to review, modify, confirm the analysis statements, and print the report. The original ECG waveform data is stored permanently in the user's server computer securely. The system uses a machine learning based process (convolutional neural network or CNN) only for development of the AI ECG algorithm. The AI ECG algorithm is only used for beat classification. After the AI ECG algorithm is developed, the AI-based beat classification model is locked in the released product which means the marketed device doesn't have active machine learning or selflearning features.

Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection. Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Carewell Digital Electrocardiographs, ECG-1101G(I) / ECG-1103G(I)/ ECG-1103LW(I) / ECG-1106L /ECG-1112 / ECG-1112D, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, fittered and analyzed, the ECG signal waveforms and analysis results are displayed on the LCD and recorded on the paper through thermal printer. ECG data, result and patient information could be stored in the memory of the device. All the models, ECG-1101G(1) / ECG-1103G(1) ECG-1103LW(1) / ECG-1106L /ECG-1112 / ECG-1112D of the proposed device, Carewell Digital Electrocardiographs, have difference in appearance. but follow the same design principle and similar technical specifications: They consist of three modules, which are power module and control module, and they have three operation modes, including AUTO Mode (automatic mode), MAN Mode (manual mode) and ANA Mode (analysis mode). They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.