Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
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Zhongguo Yi Liao Qi Xie Za Zhi · Sep 2017
[Discussion on the Existing Problems and Countermeasures of Medical Devices (Ⅱ) Clinical Trial].
To provide reference for further improve the level of medical devices clinical trial, to ensure the medical devices quality combing with the problems found in the medical devices clinical trial in Shandong province, the problems and countermeasures of medical devices (Ⅱ) clinical trial were explored. Four countermeasures were put forward to solve the problems of medical devices (Ⅱ) clinical trial from different angles including sponsors, clinical trials institutions and the important part of clinical trials:raising the threshold of entry, consummating relevant laws and regulations, establishing quality management system, strengthening personnel training, attaching great importance to CRA and CRC.
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Zhongguo Yi Liao Qi Xie Za Zhi · May 2016
[RapidArc Delivery Performance Using EDR2 Film and EPID Measurement].
This study describes the development and implementation of EDR2 film and electronic portal imaging device (EPID) during RapidArc QA. The tests were designed to evaluate RapidArc performance using EDR2 film and EPID tools. The accuracy of MLC position during gantry rotation, the ability to vary and control the dose-rate and gantry speed, the synchronization of variable MLC speed and dose-rate were examined. ⋯ The analysis of dose value was less than 2%. This study demonstrated that EDR2 film and EPID system can be used as reliable and efficient quality assurance tools for RapidArc delivery performance. Of course, the use of VMAT QA with EPID increases the efficiency of routine QA.
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Zhongguo Yi Liao Qi Xie Za Zhi · Jan 2016
[Observation and Repairment of Tidal Volume Abnormal Fault of Anesthesia Machine].
Anesthesia machine is an important equipment of clinical surgery. This paper introduces several abnormal conditions of the anesthesia machine, especially the judgment and the common fault check of the tidal volume for reference.
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Zhongguo Yi Liao Qi Xie Za Zhi · Jul 2015
[The Study of the Measurement of Heart Rate Variability Using ECG and Photoplethysmographic Signal].
In comparison with the measurement of heart rate variability from ECG and from photoplethysmographic signal from 46 healthy adults in their spontaneous breathing state. The beat-to-beat intervals in ECG and pulse-to-pulse intervals in photoplethysmographic signal are extracted, and then the parameters of heart rate variability are calculated. ⋯ The results show that the correlation coefficients of the HRV parameters in the two calculation methods are highly correlated. The Bland-Altman scattered plots show the relative bias results from the algorithm of the maximum of PPG signal are smallest and singular points that deviate from the consistent limits are the least compared with the other two algorithms.
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The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.