[Analysis on Key Points of Safety and Effectiveness Evaluation of Wearable Rehabilitation Walking Aid Robot].

OBJECTIVE: To analyze the key points of evaluation on the safety and effectiveness of wearable rehabilitation walking aid robot, then improve its quality control ability. METHODS: Combined with the functional and structural characteristics of the wearable rehabilitation walking aid robot, the key points of quality evaluation were analyzed from the aspects of electrical safety and main performance. Some reasonable suggestions were put forward for the design and development of the robot. RESULTS: The key points of safety and effectiveness evaluation of wearable rehabilitation aid walking robot focused on battery, protection device, operation parameters, static load strength, network security, environmental adaptability and other aspects. CONCLUSIONS: By analyzing the key points of safety and effectiveness evaluation of wearable rehabilitation walking aid robot, certain ideas are provided for the design and development of such products, and reference is provided for the improvement of product quality evaluation system.

[Simulator of Heart Rate and Respiratory Rate for Monitoring Accuracy of Intelligent Sleep Monitoring Devices].

OBJECTIVE: Invent a simulator which provides a simulation of heart rate and respiratory rate to the intelligent sleep monitoring devices based on precision pressure sensors. METHODS: The simulator was composed of control part and simulated silicone doll. The simulated silicone doll contains heartbeat simulator and breathing simulation airbag. Heartbeat and breathing combination pressure signal can be produced according to frequency set values. Frequencies of pressure signal of the simulator were compared with the monitoring results of intelligent sleep monitoring devices with known accuracy to verify the frequency accuracy of pressure signal of the simulator. Verified the repeatability and stability of the simulator with a stopwatch. RESULTS: The heart rate of the simulator was with in ±2 beats per minute of the monitoring results of intelligent sleep monitoring devices and the respiratory rate of the simulator was with in ±2 times per minute of the monitoring results. The repeatability and stability of the simulator was better than ±5% according to results with a stopwatch. CONCLUSIONS: It's practicable to use the simulator which provides a simulation of heart rate and respiratory rate to the accuracy test of the intelligent sleep monitoring devices based on precision pressure sensor.

[Discussion on Testing and Standard of Blood Pressure Sensor at the Tip of Catheter].

With the implementation of the new policy for coronary stent centralized volume purchasing in China, the blood pressure sensor at the tip of the catheter, as one of the essential medical instruments for the diagnosis and treatment of coronary artery disease, will meet the new development opportunity of the industry, a number of medical device companies will actively participate in the development and registration of the catheter tip blood pressure sensor. As an invasive blood pressure sensor, the catheter tip blood pressure sensor should meet the current effective industry standard YY 0781-2010, however, there are many problems when using YY 0781-2010 as a blood pressure sensor because of the difference of product structure and working mode. In this paper, the problems about "Operation Manual", "electrical performance" and "safety requirement" in the course of carrying out YY 0781- 2010 with the blood pressure sensor on the tip of catheter are discussed and analyzed in detail, hope to provide some inspiration for more research and development enterprises of blood pressure sensors on the tip of catheters and inspectors of medical device testing institutions, also hope to be able to contribute to the high-quality development of blood pressure sensor industry at the tip of the Catheter.