Author(s)

Bo Zhang¹, Tao Zhu², Tao Hu^2*, Jing Li², JiaBing Zhu², ZiYan Wan²

Affiliation(s)

¹Department of Cardiac Function, The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan 430070, Hubei, China.

²Wuhan Zoncare Bio-Medical Electronics Co., Ltd., Wuhan 430070, Hubei, China.

Corresponding Author

Tao Hu

ABSTRACT

This prospective, paired comparative study aimed to evaluate the diagnostic accuracy and safety of a multi-channel digital ECG system (Zoncare company, E-Series) against a conventional device (ED** company, SE-Series) in a clinical setting. A total of 154 participants were categorized into three groups—normal ECG, arrhythmia, and ST-segment elevation/depression—and underwent sequential ECG recordings with both devices in randomized order. Key parameters, including heart rate, PR interval, QRS duration, QT interval, and the axes of the P wave, QRS complex, and T wave, and ST-segment deviation, were automatically measured by both systems, with ST-deviation also assessed manually. Results indicated no statistically significant differences (P > 0.05) in any parameter between the two devices. Manual evaluation confirmed 100% recognition accuracy of ST-segment elevation or depression by the E-Series, with no significant difference in deviation magnitude (P > 0.05). Automatic measurements exhibited exceptionally high inter-device correlation, with r-values approaching 1 (all P < 0.001). No device-related adverse events were recorded throughout the study. In conclusion, the Zoncare E-Series multi-channel digital ECG system demonstrated diagnostic non-inferiority compared to the conventional reference device across a spectrum of cardiac rhythms and ischemic manifestations, supporting its reliability and safety for clinical electrocardiographic acquisition.

KEYWORDS

Accuracy; Electrocardiograph; Multichannel; ECG parameters; ST-segment deviation; Arrhythmias; Safety

CITE THIS PAPER

Bo Zhang, Tao Zhu, Tao Hu, Jing Li, JiaBing Zhu, ZiYan Wan. Evaluation of performance and safety of the 12-lead ECG: a prospective simultaneous paired comparative study. Journal of Pharmaceutical and Medical Research. 2026, 8(1): 21-27. DOI: https://doi.org/10.61784/jpmr3063.

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