医用高频电刀波峰因子质量检测及其应用研究  

Quality detection and application of medical high frequency electrotome crest factor

作　　者：苌飞霸 袁先举 廖婧容 周翔 王子洪 郭海涛 CHANG Fei-ba;YUAN Xian-ju;LIAO Jjing-rong;ZHOU Xiang;WANG Zi-thong;GUO Hai-tao(Department of Medical Engineering,The First Affiliated Hospital of Army Medical Unirersity,Chongqing 400038,China)

机构地区：[1]陆军军医大学第一附属医院医学工程科,重庆400038

出　　处：《生物医学工程与临床》2022年第5期626-630,共5页Biomedical Engineering and Clinical Medicine

基　　金：重庆市科卫联合医学科研项目(2020MSXM022)。

摘　　要：目的 医用高频电刀是临床普遍应用的电外科医疗器械,为了确保其工作性能稳定及临床应用安全性,需要对高频电刀的各项参数进行严格的质量控制检测。方法 选择陆军军医大学第一附属医院6个品牌共计98台医用高频电刀,其中山东玉华9台,上海沪通6台,OLYMPUS 7台,ERBE 64台,COVIDIEN 5台,AESCULAP 7台。选择波峰因子(CF)作为高频电刀输出波形质量检测的关键指标,测量和分析高频电刀不同工作模式下(双极、电切模式3个、电凝模式3个)CF参考范围。结果 双极,CF最高是上海沪通品牌。电切模式,低切,CF最高是上海沪通品牌;纯切,CF最高是山东玉华品牌;混切,CF最高是OLYMPUS品牌。电凝模式,低凝、中凝、高凝,CF最高是OLYMPUS品牌。所有品牌高频电刀在正常工作模式下的CF都在标准规范要求范围内。结论 CF不仅可以有效衡量高频电刀输出波形稳定性,而且可以评价高频电刀的电切、电凝效果。医用高频电刀CF质量检测及其应用研究为确保医用高频电刀在临床中的安全使用、保障患者的安全提供了参考依据,为高频电刀的质量检测工作提供了相关参考标准。Objective To perform strict quality control testing for parameters of high frequency electrotome and ensure the stable performance and clinical application safety, because medical high frequency electrotome is widely used in clinical electrosurgery. Methods A total of 98 medical high-frequency electrotome of 6 brands from the First Affiliated Hospital of Army Medical University were selected, including 9 sets of Shandong YUHUA, 6 sets of Shanghai HUTONG, 7 sets of OLYMPUS,64 sets of ERBE, 5 sets of COVIDIEN and 7 sets of AESCULAP. The crest factor(CF) was selected as the key indicator for quality detection of high-frequency electrosurgical output waveform, and CF reference range in different working modes(bipolar, 3 normal working modes of electrocution or electrocoagulation) of high-frequency electrotome was measured and analyzed.Results The highest CF was HUTONG in bipolar cutting mode. For electric cutting mode, the highest CF value was HUTONG in low-cutting mode. The highest CF value was YUHUA in pure cutting mode;the highest CF was OLYMPUS in mixed cutting mode. For electric coagulation mode, the highest CF was OLYMPUS in low coagulation, medium coagulation and high coagulation. The CF of all brands of high frequency electrotome at normal working mode were in the standard range. Conclusion It is demonstrated that CF could effectively measure output waveform stability of high frequency electrotome and evaluate its electrocutting and coagulation effects. The quality detection and application research of CF provides the reference basis for safety application in clinical and patient, which shows relevant reference standards for quality detection of high frequency electrotome.

关 键 词：高频电刀 质量检测 波峰因子 检测指标 

分 类 号：R197.39[医药卫生—卫生事业管理] R612[医药卫生—公共卫生与预防医学]