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AUTOMATIC VALIDATION TECHNIQUES FOR VALIDATING OPERATION OF MEDICAL DEVICES

机译:用于验证医疗设备操作的自动验证技术

摘要

Techniques for validating operation of a medical device are disclosed. A data collection phase utilizes a first sensor carried by a patient to record patient parameter values indicative of conditions experienced by the patient (e.g., posture states). Therapy parameter values describing therapy adjustments requested by the patient in response to the conditions are also recorded. Associations formed between the therapy parameter values and the patient parameter values are used to develop a closed-loop algorithm for control of an IMD having a sensor similar to the first sensor. An automated device such as a robotic arm uses the recorded patient parameter values to automatically reproduce conditions present during the data collection phase. Therapy delivered by the IMD while under control of the closed-loop algorithm and while being subjected to the conditions is compared to the recorded therapy parameter values e to validate IMD operation.
机译:公开了用于验证医疗设备的操作的技术。数据收集阶段利用由患者携带的第一传感器来记录指示患者经历的状况(例如,姿势状态)的患者参数值。还记录了描述患者根据条件要求进行的治疗调整的治疗参数值。在治疗参数值和患者参数值之间形成的关联用于开发闭环算法,以控制具有类似于第一传感器的传感器的IMD。诸如机械臂的自动化设备使用记录的患者参数值来自动重现在数据收集阶段出现的状况。将IMD在闭环算法的控制下且处于条件下的治疗与记录的治疗参数值e进行比较,以验证IMD的操作。

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