心室辅助装置基本性能研究

Study on Essential Performance of Ventricular Assist Device

目的 开展心室辅助装置电气安全和电磁兼容评价中的基本性能研究,为检验检测工作提供技术支撑。方法 通过对通用安全标准、电磁兼容标准和产品本身性能的分析和研究,确定心室辅助装置应涵盖的基本性能,并对评价方法进行解析。结果 通用标准解析表明,心室辅助装置性能(包括转速、流量、功率、流量特性、抗扭摆振动能力、密封性、溶血要求、启动性能等)和控制精度(包括转速、流量、功率等)应作为基本性能评价的指标,报警、辅助设备性能宜作为基本性能评价指标。结论 通过标准的解析和产品的研究,对心室辅助装置的基本性能确定提出了建议和方法,可为此类设备的检验检测工作奠定研究基础,同时对其他设备的基本性能研究也有一定的借鉴意义。

Objective To study the essential performance of electrical safety and electromagnetic compatibility evaluation of ventricular assist device(VAD),to provide technical support for quality assurance.Methods Through the analysis and research of general safety standards,electromagnetic compatibility standards and product performance,the basic performance of VAD was determined,and the evaluation method was analyzed.Results General standard analysis concluded that the performance of VAD(including rotational speed,flow,power,flow characteristics,anti-vibration ability,sealing,hemolysis requirements,starting performance,etc.)and control accuracy(including rotational speed,flow,power,etc.)should be taken as the indicators of basic performance evaluation,and the performance of alarm and auxiliary devices should be taken as the indicators of basic performance evaluation.Conclusion Through standard analysis and product research,suggestions and methods are put forward to determine the basic performance of VAD,which lays a research foundation for the inspection and detection of such devices.At the same time,it has reference significance for the basic performance research of other devices.