【摘要】 目的 研制一款智能腔镜器械电气绝缘安全检测仪以确保腔镜手术带电器械术中绝缘性能安全，并探讨其应用效果。方法 在原型机基础上进行升级改造，研发配套软件管理系统并将两者进行整合，研发一款全新国产的智能腔镜器械电气绝缘安全检测仪。于2019年8月～2020年10月进行临床试用，与传统人工目检法进行比较和评估，并对相关数据统计分析。结果 利用人工目检法和智能腔镜器械电气绝缘安全检测仪两种方法对190件腔镜电外科器械的绝缘破损点以及绝缘破损检出率进行统计，人工目检法共检出绝缘破损点数量7件，智能腔镜器械电气绝缘安全检测仪检出绝缘破损点数量共39件，显著高于人工目检法（P<0.05）。人工目检法和智能腔镜器械电气绝缘安全检测仪检出的绝缘破损率分别为3.68%(7/190)和20.53%(39/190)，两者之间差异有统计学意义（P<0.05）。人工目检法的工作人员数量为4位，平均检测用时分别为（40.78±2.63）s/件，智能腔镜器械电气绝缘安全检测仪工作人员数量仅需1位，平均检测用时分别为（10.86±0.00）s/件，智能腔镜器械电气绝缘安全检测仪检测的人力成本投入明显优于人工目检法。检测结果记录平均耗时分别为（29.18±2.91）s/10件和（5.15±0.00）s/10件，智能腔镜器械电气绝缘安全检测仪检测的时间成本投入明显优于人工目检法。人工目检法和智能腔镜器械电气绝缘安全检测仪法医护满意度分别是72.86%和96.71%，两者之间差异有统计学意义（P<0.05）。结论 智能腔镜器械电气绝缘安全检测仪可以提供更为安全高效的检测，提高医院的工作效率和安全质量。更多还原

【Abstract】 Objective To develop an intelligent endoscopic instrument electrical insulation safety detector to ensure the intraoperative insulation safety of surgical charged instruments, and to explore its application effect. Methods Based on the original prototype, the transformation and upgrading were carried out, the supporting software management system was developed, and the two were integrated. A brand-new domestic intelligent electrical insulation safety detector was developed. Clinical trials were conducted between August 2019 and October 2020 to compare and assess the traditional manual visual inspection. The relevant data were statistically analyzed. Results The number of insulation damage points and the detection rate of insulation damage in 190 endoscopic instruments were statistically analyzed by manual visual inspection and intelligent endoscopic instrument electrical insulation safety detector at the same time. The manual visual inspection detected seven insulation damage points. The intelligent endoscopic instrument electrical insulation safety detector detected 39 insulation damage points, significantly higher than that by manual visual inspection(P<0.05). The insulation damage rates detected by manual inspection and intelligent endoscopic instrument electrical insulation safety detector were 3.68%(7/190) and 20.53%(39/190), respectively, with a statistically significant difference(P<0.05). The number of detection personnel of manual visual inspection method was 4, and the average detection time was(40.78±2.63) s/piece. The number of detection personnel of intelligent endoscopic instrument electrical insulation safety detector was only 1. The average detection time was(10.86±0.00) s/piece, respectively. The labor cost investment of intelligent endoscopic instrument electrical insulation safety detector was significantly lower than that of the visual inspection method. The average time of recording the detection results was(29.18±2.91) s/10 pieces and(5.15±0.00) s/10 pieces,respectively. The time cost investment of detection by the intelligent endoscopic instrument electrical insulation safety detector was significantly lower than the visual inspection method. The satisfaction rate of medical care was 72.86%and 96.71% by manual visual inspection and intelligent endoscopic instrument electrical insulation safety detector, respectively. There was a statistical difference between the two groups(P<0.05). Conclusion Intelligent endoscopic instrument electrical insulation safety detector can provide more safe and efficient detection and improve the work efficiency and service quality of hospitals.更多还原