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English

Even if the device does no harm and is deemed safe to use, this does not mean that the device actually does what is intended. So, clinical trials are intended to demonstrate that the device does what the company claims for it within the generally accepted accuracy and tolerances associated with the condition being monitored. For example, while wrist-worn devices are popular due to their conventional form factor, it is difficult to extract meaningful medical results from that location due to motion artifacts due to the physiology of the wrist, skin variations, and even the mechanical fit to the wrist.

Chinese

但即使器械没有危害,看来使用也是安全的,也不意味器械实际上就是如此,还是要经过临床试验,确认是否达到制造商所述的各项指标和功能,精度和偏差是否在可接受范围内。 例如,腕带式器械用得很普遍,因为这种形式很容易被大家接受,但是,在这个位置上提取对医疗有意义的结果是很难的,因为接受到的信息有运动失真,会受到腕部的生理反应、皮肤变化、甚至与腕部的机械配合的影响。