新生儿蓝光治疗仪质控检测实践方法研究  

Discussion on the Practice Method of Quality Control Testing for Neonatal Blue Light Therapy Instrument

作　　者：麦达成 陈炜业 肖翔 陈远鹏 张学文 陈广源 MAI Dacheng;CHEN Weiye;XIAO Xiang;CHEN Yuanpeng;ZHANG Xuewen;CHEN Guangyuan(Equipment Department,The Affiliated Panyu Central Hospital of Guangzhou Medical University,Guangzhou Guangdong 511400,China;Medical Device Management Branch of Guangdong Grassroots Medical Association,Guangzhou Guangdong 511400,China)

机构地区：[1]广州医科大学附属番禺中心医院设备科,广东广州511400 [2]广州市番禺质量技术监督检测所,广东广州511400

出　　处：《中国医疗设备》2025年第3期57-63,共7页China Medical Devices

基　　金：广州市番禺区科技计划项目(2023-Z04-029);广东省医学会医学工程学分会青年委员会科研课题项目(2023-GDMAZZ-11)。

摘　　要：目的为解决目前缺乏有效可行的新生儿蓝光治疗仪质控检测办法,尤其缺乏辐照性能的质控检测规范的问题,研究一种新生儿蓝光治疗仪质量控制检测办法,以确保其治疗效果。方法根据新生儿蓝光治疗仪的治疗原理和设计原理,从设备外观及日常管理、运行状态、辐照性能3个方面制定质控检测办法。其中,辐照性能包括辐照面积及距离、辐照强度。另外,使用垂直尺和水平尺作为对照组,与研制的蓝光辐射辅助测量装置(观察组1)、人手质控(观察组2)进行对比,以验证规范质控的重要性。结果上蓝光辐照强度和下蓝光辐照强度的各检测内容的最大值、最小值、平均值均在《YY 9706.250-2021医用电气设备第2-50部分》和《新生儿高胆红素血症诊断和治疗专家共识》的允许范围内,且差异有统计学意义(P<0.001)。研究明确提出移动式蓝光治疗仪在强光疗时应距离婴儿培养箱25 cm以上。在蓝光辐射辅助测量装置和人手质控的对比实验中,观察组2测量结果的离散程度比观察组1更大,差异均有统计学意义(P<0.001),且观察组1测量结果与对照组测量结果接近。结论新生儿蓝光治疗仪质控检测办法切实可行,符合《YY 9706.250-2021医用电气设备第2-50部分》和《新生儿高胆红素血症诊断和治疗专家共识》的有关规定。Objective To solve the problem of the lack of effective and feasible quality control testing methods for neonatal blue light therapy instrument,especially the lack of radiation performance quality control testing standards,to study a quality control testing method for neonatal blue light therapy instrument to ensure its therapeutic effect.Methods According to the treatment principle and design principle of the neonatal blue light therapy instrument,the quality control testing method was developed from the three aspects such as equipment appearance and daily management,running state and irradiation performance.Among them,irradiation performance included irradiation area and distance,irradiation intensity.In addition,the vertical ruler and level ruler were used as the control group to compare with the developed blue ray radiation auxiliary measuring device(observation group 1)and manual quality control(observation group 2)to verify the importance of standard quality control.Results The maximum,minimum and average values of the upper and lower blue light irradiation intensity were all within the permissible range of YY 9706.250-2021 Medical Electrical Equipment Part 2-50 and Expert Consensus on Diagnosis and Treatment of Neonatal Hyperbilirubinemia,and all differences were statistically significant(P<0.001).The study clearly suggested that the mobile blue light therapy device should be more than 25 cm away from the infant incubator during intense light therapy.In the comparison experiment between blue light radiation auxiliary measuring device and human hand quality control,the measurement results of observation group 2 were more discrete than those of observation group 1,with statistical significance(P<0.001),and the measurement results of observation group 1 were close to those of control group.Conclusion The quality control test method of neonatal blue light therapy instrument is feasible and in line with the relevant provisions of YY 9706.250-2021 Medical Electrical Equipment Part 2-50 and Expert Consensus on Di

关 键 词：蓝光治疗仪 质控检测 辐照距离 辐照强度 辐照性能 

分 类 号：R197.39[医药卫生—卫生事业管理]