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目的:评价南京普爱公司生产的高频移动式手术X线机临床应用的安全性能及操作性能。方法:参照国家关于新药临床验证的指导原则和医疗器械操作规范,以惠尔公司DigiArc-100型X线机为对照机型,通过临床60例受试者实施拍片和透视,进行国产PLX112C型X线机的临床验证。结果:2种设备拍片、透视的图像质量基本相同。结论:本验证产品操作方便,性能可靠、安全,能满足临床使用需要。
Objective: To evaluate the safety and performance of clinical application of high-frequency mobile surgical X-ray machine manufactured by Nanjing Puai Company. Methods: According to the guidelines of the state on the clinical validation of new drugs and the operation rules of medical devices, the X-ray machine DigiArc-100 of Whirlpool was used as a control model. 60 clinical subjects were involved in filming and fluoroscopy. The domestic PLX112C X Line machine clinical validation. Results: Two kinds of equipment, film, perspective image quality is basically the same. Conclusion: This verification product is easy to operate, reliable, safe and can meet the needs of clinical use.