体外起搏器校准装置的研制

Development of a Calibration Device for External Pacemakers

体外起搏器是一种通过电刺激来治疗心律失常,实现心脏起搏的医疗设备,其关键计量参数的准确性关系到患者的生命安全,有必要定期进行校准。针对这一校准需求,研制了一种体外起搏器校准装置,实现了对体外起搏器脉冲幅度、脉冲宽度、脉冲频率、感知灵敏度、不应期等参数的校准。重点介绍了体外起搏器校准装置的工作原理与软硬件的设计方法,并对校准装置的关键参数进行了测试,结果表明其技术指标达到了体外起搏器校准需求。该校准装置具有体积小、操作方便、准确度高等优点,解决了体外起搏器缺少校准装置的关键问题,完善了量值溯源体系,有助于降低体外起搏器的临床风险。

An external pacemaker is a medical device that treats arrhythmia and facilitates cardiac pacing through electrical stimulation.The precision of its key metrics is crucial to patient safety,necessitating regular calibration.Addressing this calibration need,we developed a calibration device for external pacemakers capable of calibrating parameters such as pulse amplitude,pulse width,pulse frequency,sensing sensitivity,and refractory period.This paper presents the working principles and the design methodology of both the software and hardware of the calibration device,and the testing of its key parameters.The results demonstrate that the technical characteristics of the calibration device fulfill the calibration requirements of external pacemakers.The device,compact,user-friendly,and highly accurate,resolves the pivotal issue of the absence of a dedicated calibration device for external pacemakers.It enhances the traceability system of measurement values and contributes to lowering the clinical risk associated with external pacemakers.