摘要
目的从医疗器械质量控制的视角来评价手机闪光灯用于医疗用途的有效性和安全性,探讨手机在移动医疗领域的潜力。方法把闪光灯当作检眼镜的光源,对其光辐射安全性进行评价。以闪光灯为光源,光纤光谱仪为探测器,进行反射式血氧测量,分析获得的信号特征。结果手机检眼镜的光辐射风险主要取决于蓝光,本文手机检眼镜的应用情景根据ISO15004-2:2007标准应属于2类设备,手机闪光灯在组织中产生的信号可用于反射式血氧测量。结论手机作为日常生活广泛普及的个人物品和移动医疗的重要节点,其闪光灯本身具有医用价值和安全风险,有必要对它的研发和监管继续深入研究。
Objective To evaluate the effectiveness and safety of mobile flashlight from the perspective of medical device quality control so as to explore its potential in mobile health. Methods Taking mobile flashlight as the light source of ophthalmoscope, its optical radiation risks were evaluated. Using flashlight as the light source and a fiber optical spectrometer as the detector, measurement of reflective oximetry was made to analyze the signal. Results The optical radiation risk of mobile ophthalmoscope mainly depended on the blue light, and the application scenario in this paper was considered as Class 2 equipment according to ISO 15004-2：2007. The reflectance signal on tissue generated by the flashlight was useful for oximetry measurement. Conclusion As a common personal belonging and basic element in mobile health, the flashlight in cell phones had medical application effects and security risks, which should draw more attention from the research development departments to the regulation authorities.
出处
《中国医疗设备》
2016年第8期34-36,43,共4页
China Medical Devices
基金
国家科技支撑计划项目(2015BAI43H00)
中国食品药品检定研究院中青年基金项目(2015C02)
