监护仪平安特点清单(国外英文资料).docVIP

监护仪安全特征清单(国外英文资料) Multi-parameter monitor safety feature list A1 general The first step in determining the harm is to analyze the characteristics of medical devices that may affect safety. One way is to raise a series of questions about the manufacturing, use and final disposal of medical devices. If from all involved personnel (such as users and maintenance personnel, patients, etc.) point of view, to ask these questions, there will be a able to find a more complete picture of possible harmful effects. The following questions help readers determine all possible hazards of the analyzed medical apparatus. These questions are not completely exhaustive, and ask the reader to add to the problems that apply to certain medical devices. A. what is the intended use/expected purpose and how to use medical instruments? Factors to consider include the expected user, the users mental and physical ability, skill and training, the man-machine engineering problems, the use environment of medical apparatus and instruments and installation by who, and patients will be able to control or influence the use of medical devices. It is important to note that those who have special needs, such as the disabled, the elderly and the children. Their special needs may include assistance from other personnel to use medical devices. Medical devices are expected to be used by individuals with different skill levels and cultural backgrounds. Expectations of medical equipment in disease diagnosis, prevention, care, treatment or ease, trauma and disability compensation, anatomical replacement or correction of the pregnancy control function. Are medical devices used for life support or life support? Do you need special intervention in case of medical device failure? Is there any special problem with interface design that can lead to careless usage errors (see a.27)? A2.1 Expected users: various clinical departments in the hospital, such as: emergency room, operating room, heart, heart with, neurology