This study introduced the current testing content and standards of ECG medical electronic instruments, combined with actual clinical needs, and discussed the comprehensive verification and evaluation protocol for ECG medical electronic instruments. The protocol mainly includes hardware performance testing, automatic diagnostic function testing and clinical application evaluation. The protocol emphasizes the clinical practicality and importance of the comprehensive verification and evaluation program, and provides a reference for the institutions involved in the program.
Electrocardiography ; Electronics, Medical ; Reference Standards

Medical electronic endoscope is one of the indispensable tools in medical diagnosis and treatment. With the development of science and technology, electronic endoscope has higher safety and accuracy than traditional optical endoscope. Due to the sophisticated construction and high price, hospitals spend a lot of money on maintenance every year. In order to prolong the working life of electronic endoscope, reduce the incidence of artificial failure and save hospital costs, this study made a retrospective analysis on the common faults of electronic endoscope, and summarized the maintenance strategies for reference.
Electronics, Medical ; Endoscopes ; Retrospective Studies

The eRPS system for medical device registration of National Medical Products Administration was officially launched on June 24, 2019. This paper focused on the following two aspects of the electronic declaration process of medical device regulatory agencies in the whole world:one is whether the electronic submission format is consistent, the other is whether the electronic submission path is convenient. Suggestions are put forward for the next nationwide implementation of the electronic submission so as to speed up the process of the electronization of medical device evaluation in China.
China ; Electronics, Medical

No abstract available.
Electronics, Medical ; Defibrillators, Implantable ; Anti-Bacterial Agents ; Hematoma ; Pacemaker, Artificial

This paper presents a three-dimensional electronic laparoscopy system, including three-dimensional laparoscope pipe and medical video system. The three-dimensional laparoscope pipe adopts a dual-optical structure, which can collect three-dimensional information of the surgical region. By selecting a reasonable initial structure, the MTF curve of the objective lens is close to the diffraction limit, and the distortion is less than 25%. The medical video system also achieved high-definition image with 1 080 P, 30 Hz by GPU. At the mean time, the three-dimensional electronic laparoscope has achieved quantitative production and has been tested in a number of animals, which has broad application prospects and significant clinical application value.
Electronics, Medical ; Imaging, Three-Dimensional ; Laparoscopes ; Laparoscopy

This study presents an electronic portal imaging devices (EPIDs) based on daily check tool for Linac that is usable for different cancer centers.Several images of open rectangle fields were acquired with EPID and the key items of daily Linac check were derived from the obtained images using an in-house developed automatic analysis software.The experiment results showed that each parameter calculated by this tool is as reliable as the corresponding result measured by the commercial quality assurance devices and its measuring efficiency is much higher.
Electronics, Medical ; Electrons ; Particle Accelerators ; Phantoms, Imaging ; Radiometry ; Software

OBJECTIVE: To establish a method for measuring the photoelectric performance index (luminance response characteristic and luminance tolerance) of medical electronic endoscope. METHODS: Based on the clinical application and product features of medical electronic endoscope, the umbrella grayscale test chart and the adjustable gray scale test chart are designed and made from two aspects of distribution and density differential. RESULTS: The influence of gray scale arrangement, background illumination intensity and illumination spectrum on photoelectric performance measurement of electronic endoscope is verified by test. CONCLUSIONS It is a reference for the design analysis, evaluation and modification of electronic endoscope product photoelectric part, whether it is suitable for fast detection of umbels and more accurate gray scale test chart.
Electronics, Medical ; Endoscopes ; Light ; Quality Control

Around the features of low power and high integration of portable electronic medical equipment design, the primary low power MCU series from the current semiconductor manufacturers were compared. The analysis results showed that the 32-bit MCUs based on the low cost and high energy efficient ARM Cortex-M architectures, have comprehensive advantages on power level, operational performance and integrated peripherals obviously.
Electronics, Medical ; instrumentation ; Equipment Design

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind.
Biocompatible Materials ; Biomedical Engineering ; Blood Pressure ; Cochlear Implants ; Corrosion ; Electronics, Medical ; Humans ; Medical Staff ; Micro-Electrical-Mechanical Systems

The article introduces the requirements of accompanying documents on the new EMC standard of medical electrical equipment (YY 0505-2012), hope it can be useful for the manufacturers of medical electrical equipment.
Electronics, Medical ; instrumentation ; Equipment and Supplies ; standards