国产心电图机数据采集精度与自动分析准确性的评估

Evaluation of domestic ECG machine on the accuracy of data acquisition and automatic analysis

目的探讨国产心电图机与进口心电图机性能的等效性。方法入组100例受试者,随机分为A、B两组,即国产心电图机分别与两款进口心电图机各对照50例,保持仪器设置相同,以3通连接导联线,同时、同步采集同一受试者常规12导联的心电信号。结果用三种统计学方法分析仪器自动测量的8项参数以及各波形振幅,均证实国产心电图机与进口心电图机所得数据差异无统计学意义,一致性和相关性好。结论以客观数据证实国产心电图机与进口心电图机在性能上是等效的,国人可以放心使用。

Objective To explore the equivalence of performance between domestic and imported ECG machines. Methods One hundred subjects were randomly divided into group A and B,each with 50 cases. In group A,routine 12-lead ECG was recorded simultaneously by ECG machine produced by Wuhan Zoncare Company（ type 1） and ECG machine produced by General Electric Company（ type 2）. In group B,routine 12-lead ECG was recorded simultaneously by type 1 ECG machine and ECG machine produced by Philips Electronics（ type 3）. The three types of ECG machines were set the same collection parameters,connected the lead wires of different types of machines with three links,and collected the routine 12-lead ECG signals of the same subject simultaneously and synchronously. Results Eight parameters and the amplitude of each waveform automatically measured by the equipments were analyzed by three statistical methods. Analysis results all confirmed that there was no statistical difference between the data separately obtained by domestic and imported ECG machines. It demonstrated good consistency and correlation of the data. Conclusion The objective data supports the equivalence of performance between domestic and imported ECG machines. And our fellow countrymen can utilize the domestic ones with confidence.