Extracorporeal pacemaker is cardiac rhythm management device with non-implantable pulse generator and is widely used medical institutions. Parameters such as pulse duration, pulse amplitude, pulse rate, sensibility, and PVARP can directly decide the metrological performance of the instrument. However, at present, there is no relevant calibration specification for extracorporeal pacemaker in China to calibrate the important parameters. This article presents a novel calibration method for extracorporeal pacemaker by determining corresponding environmental conditions, calibration standards, and calculation equations. The calibration results of the important parameters can meet the requirements of GB 16174.2-2015 Implants for surgery - Active implantable medical devices - Part 2 Cardiac pacemakers, which shows that the calibration method is scientific and practical for metrological performance evaluation of extracorporeal pacemaker.
Keywords: PVARP; calibration; extracorporeal pacemaker; pulse; sensibility.