1.Analysis on the quality detection of different brands of spectrum therapy apparatus in complex environment
Yang LI ; Aowen DUAN ; Jing HUANG ; Hehua ZHANG
China Medical Equipment 2024;21(6):25-28
Objective:To analyze the results of quality detection of different brands of spectrum therapy apparatuses in complex environment,so as to improve the reliability of that in clinical use and to provide reference for medical institutions in selecting spectrum therapy apparatus that suits to different environments.Methods:A total of 4 different brands of spectrum therapy apparatuses(brand A,B,C,D)were selected,and the environments of cold,hot,wet and heat,and salt fog area were respectively simulated.The detection tests of low temperature storage,high temperature storage,wet and heat storage,and salt fog were conducted on the spectrum therapy apparatuses.According to the national standard"Environmental requirements and test methods for medical electrical equipment"and"Laboratory environmental test methods for military materiel Part 11:salt fog test",the results of quality tests of appearance function and temperature control of the spectrum therapy apparatuses after the test were analyzed.Results:In the test of appearance function,the appearance functions of brand A,brand B and brand C were normal in the tests of low temperature storage,high temperature storage,wet and heat storage,and salt fog,and brand D only showed obvious surface corrosion after salt fog test.In the test of temperature control,the errors of the temperature non-uniformity of the 4 spectral therapy apparatuses were less than 10%after the tests of low temperature storage,high temperature storage,wet and heat storage,and salt fog.The error ranges of brand B and brand D were between-10%and+10%due to the marked values of the surface temperatures of radiation devices of them were known,while those of brand A and C could not be analyzed due to the marked values of them were not known.Conclusion:The analysis on the quality detection of spectrum therapy apparatuses in the complex environment can improve the reliability of that in clinical use,and can choose the suitable brand and model for medical institutions at differently environmental regions,so as to ensure the clinical treatment effect of them.
2.Exploration on calibration method of detection of spectrum therapy instrument in low pressure environment
Yang LI ; Jing HUANG ; Aowen DUAN ; Hehua ZHANG
China Medical Equipment 2024;21(11):30-34
Objective:To explore the calibration method of quality detection of spectrum therapy instrument in low pressure environment,so as to ensure its safety and stability in clinical use.Methods:Aimed at the 4 types of vertical spectrum therapy instrument,the calibration of quality test were carried out in normal environment and the simulated low pressure environment for 5 different altitudes that included 1.0,2.5,3.5,4.5 and 5.5 km.The detection of appearance function,unevenness of surface temperature and surface error,as well as the repetition of measurement of spectrum therapy instrument among different low pressure environment were compared.Results:In the low pressure environments of 5 different altitudes,the performance parameters of 3 types of spectrum therapy instruments were better,and the error of temperature unevenness was less than 10%.The performance of one type of spectrum therapy instrument was poor,and the error of temperature unevenness was between 10%and 20%.For the error of surface temperature of radiator,one type of spectrum therapy instrument was<10%,and one type of that was>15%,and two types of that cannot be assessed because there was not specific value.In normal environment,each detection indicator of 4 spectrum therapy instruments were normal.In this trial,the repetition of the result of only 1 type of spectrum therapy instrument was relatively larger,which was between 1.5%and 2.4%,and the repetition of other types was smaller.Conclusion:The calibration and detection methods of quality test of spectrum therapy instrument was explored in this article,which can ensure the clinical therapeutic effect,safety and stability.It is helpful to reduce the risk of that in clinical use.
3.Research on technological roadmap based on theintegrated development of digestive tract endoscopy and artificial intelligence precision medicine
Rui NIE ; Aowen DUAN ; Xuesi LIU ; Jing XU ; Anhai WEI ; Hehua ZHANG
China Medical Equipment 2024;21(3):133-137
Objective:To study the technological roadmap of integrated development of digestive tract endoscopy and artificial intelligence precision medicine,and to provide research directions and feasible technological paths for the"overtaking on a curve"of domestic gastrointestinal endoscopy.Methods:The Delphi method was used to investigate the needs and research directions for the refinement of gastrointestinal endoscopy from the perspective of medical professionals.An analysis of development directions of artificial intelligence precision medical technology based on technical documents on artificial intelligence precision medical technology was conducted.The application scenarios and technology roadmap of early gastric cancer and inflammatory bowel disease patients were designed from four main service directions of precise diagnosis,precise treatment,precise medication,and precise health management of artificial intelligence precision medicine.Results:Two refined application scenarios were designed for precise diagnosis of early gastric cancer and precise health management of inflammatory bowel disease patients,the layout direction and feasible path were planned for the development of the new gastrointestinal endoscopy industry,and a technology roadmap for the development of intelligent gastrointestinal endoscopy industrywas formed.Conclusion:The technology roadmap for the integrated development of gastrointestinal endoscopy with artificial intelligence precision medicine provides a sustainable development path for addressing the patent blockade of foreign gastrointestinal endoscopy companies on domestic products,uneven distribution of medical resources in the field of gastroenterology,and early diagnosis and treatment of digestive system diseases.
4.Quality control testing and performance evaluation of polysomnography
Jing HUANG ; Li YANG ; Aowen DUAN ; Li XU ; Zhenwei DU ; Hengyu LONG ; Anhai WEI ; Kexin PAN
China Medical Equipment 2024;21(5):123-127
Objective:To research the quality control and testing methods of polysomnography and to ensure its safe and effective performance.Methods:A quality control testing method was designed for the main indicators of EEG signal,EMG signal,ECG signal,and pulse oxygen saturation of polysomnography.In August 2023,two polysomnography instruments of the same brand and different models(marked as Test Equipment A and Test Equipment B)in clinical use in Daping Hospital,Army Medical University were selected.The quality control testing of polysomnography instrument was conducted by using electroencephalogram calibration instrument and vital sign simulator to evaluate the reliability of the performance of polysomnography.Results:A quality control testing method was developed for quality control testing of polysomnography aiming at the repeatability of the indicated values of EEG signals,EMG signals,ECG signals,and pulse oxygen saturation of polysomnography.Except for the output value of 2 mV of the voltage measurement simulator of test equipment B,the relative error of the recorded data was-11%,and the parameters were out of tolerance,and the rest of the test data of test equipment A and test equipment B met the maximum limit output value of the national metrology verification regulations and the technical requirements of the equipment manufacturer.Conclusion:The quality control detection method of polysomnography can evaluate the performance parameters of the selected testing equipment A and testing equipment B,and provide technical support for the quality control detection and safe use of such equipment.
5.Research on calibration method of endoscopic liquid expansion pump
Jing HUANG ; Aowen DUAN ; Li YANG ; Xiaobo WEN ; Haijiang ZHU ; Anhai WEI ; Hengyu LONG ; Hehua ZHANG
China Medical Equipment 2024;21(10):194-197
A corresponding calibration method was proposed for the key performance parameters of the endoscopic liquid expansion pump,such as the pressure indication error,the flow rate indication error and the flow rate repeatability.4 different brands of endoscopic liquid expansion pumps in clinical use in the hospital were selected for calibration,and the feasibility of the calibration method was evaluated.In the pressure and flow range of the endoscope liquid expansion pump,3 calibration points of high,medium and low were selected,and each flow point was calibrated 3 times.The calibration results showed that the maximum error of pressure indication was 4.3%,the maximum error of flow indication was 9.3%,and the maximum repeatability of flow indication value was 0.8%,all of which met the technical requirements for the maximum allowable error of"Medical Endoscopes.Endoscope Functional Supply Units.Irrigation Pump"(YY/T 0864-2011)and"Calibration Specification for Syringe Pumps and Infusion Pumps"(JJF 1259-2018).The calibration method for endoscopic liquid expansion pump can improve the metrological traceability system of this type of equipment,ensure the accuracy and reliability of equipment values,improve product quality,and ensure medical safety.