CLINICAL EVALUATION OF AN 18-LEAD ECG DEVICE'S PERFORMANCE AND SAFETY: A PROSPECTIVE PAIRED-DEVICE STUDY

Abstract

This prospective, single-center study was designed to validate the clinical performance and safety of the Zoncare iMAC1800pro (iMAC-Series) 18-lead digital multi-channel electrocardiograph, with the ED** SE-18 as the reference standard. A total of 154 participants were enrolled and stratified into three cohorts: normal ECG (n=54), arrhythmia (n=50), and ST-segment abnormality (n=50). Each subject underwent simultaneous 18-lead ECG recordings using both devices, which were connected to the same set of skin electrodes via a standard passive Y-lead splitter cable. Key parameters including heart rate, PR interval, QRS duration, QT interval, QTc value, P-wave axis, QRS axis, T-wave axis, and ST-segment deviation were automatically measured by both systems and manually verified by senior cardiologists (with senior professional titles and more than 10 years of ECG diagnostic experience). The Zoncare iMAC1800pro showed clinical equivalence to the reference device in all measured parameters, with no statistically significant differences (P > 0.05). ST-segment elevation/depression and the maximum elevation/depression amplitude (all P > 0.05), indicating excellent consistency between the two devices in ST-segment deviation measurement. No device-related adverse events or equipment malfunctions were reported during the study. These findings confirm the clinical reliability and safety of the Zoncare iMAC1800pro for routine electrocardiographic assessment.