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作 者:刘洋 刘培 李泽楷 李双双 LIU Yang;LIU Pei;LI Zekai;LI Shuangshuang(Chengdu Shuimu Medical Technology Co.,Ltd.,Chengdu 611731,China;Beijing Zhongguancun Shuimu Medical Technology Co.,Ltd.,Beijing 102600,China)
机构地区:[1]成都水木医疗科技有限公司,四川成都611731 [2]北京中关村水木医疗科技有限公司,北京102600
出 处:《电子产品可靠性与环境试验》2023年第5期33-38,共6页Electronic Product Reliability and Environmental Testing
摘 要:在医疗器械产品改型过程中,通过对样机进行温度步进环境试验,使新品缺陷充分、快速地暴露出来是十分重要的。通过对某医疗器械电源模块进行热测试,获得电源模块在常温条件下的热场分布和特定环境温度下的各关键点温度。测试发现该医疗器械开关直流电源存在两项潜在热缺陷。由此对其两项热设计缺陷做了相应的改进,并对其改进效果进行回归验证,结果表明改进效果十分明显,有利于提升产品的可靠性与成熟度水平,保障上市后的质量与可靠性,减轻售后维修保障负担,提高客户满意度。In the process of medical device product modification,it is very important to conduct a temperature step environment test on the prototype to fully and quickly expose the defects of the new product.Through the thermal test of the power module of a medical device,the thermal field distribution of the power module under normal temperature conditions and the temperature of each key point under a specific ambient temperature are obtained.The tests found that the medical device switching DC power supply had two potential thermal defects.Therefore,the two thermal design defects are improved accordingly,and the improvement effect is verified by regression.The improvement effect is very obvious,which is conducive to improving the reliability and maturity level of the product,ensuring the quality and reliability after listing,reducing the after-sales maintenance support burden,and improving customer satisfaction.
关 键 词:医疗器械 电源模块 热测试 潜在缺陷 改进效果研究
分 类 号:R197.39[医药卫生—卫生事业管理]
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