1.Construction of evaluation indicator system for power system of otolaryngology surgery
Anhai WEI ; Jiaqing YANG ; Anfa LIU ; Mengjia JIA ; Lifen XU ; Fei LI ; Hehua ZHANG
China Medical Equipment 2025;22(11):128-131
Objective:To construct an evaluation indicator system for power system of otolaryngology surgery,so as to provide references for the configuration of surgical power devices of medical institutions.Methods:Literature review and brainstorming were used to analyze existing literature related to surgical power.Combined with expert opinions and clinical demands,an evaluation indicator system was initially proposed.The Delphi method was adopted to determine the evaluation indicators of power system of otolaryngology surgery.The analytic hierarchy process(AHP)method was used to determine the evaluation indicator system of the power system of otolaryngology surgery,which were constructed by weight of each indicator.Results:The evaluation indicator system of power system of otolaryngology surgery included 5 first-level indicators(integrity of medical equipment,products'performance indicators,safety,clinical application effect,and after-sales service guarantee)and 49 second-level indicators under the first-level indicators.In the first-level indicators,equipment's safety had the highest weight(20.48%).In the second-level indicators,the top three of the combined weights were respectively integrity of equipment's main device(7.19%),accessory's integrity(7.03%),and identification's integrity(6.03%).Conclusion:The evaluation index system for otolaryngological surgical power systems clarifies the core dimensions,specific indicators and relative importance of the evaluation,and can be applied to the procurement and selection of surgical power devices in medical institutions,performance testing,clinical effect evaluation and other aspects.
2.Analysis on the accuracy of anterior segment measurement assessment system and optical biometer in predicting lens in ICL implantation
Anhai WEI ; Yangcheng ZOU ; Mengjia JIA ; Anfa LIU ; Hehua ZHANG
China Medical Equipment 2025;22(8):41-45
Objective:To explore the accuracy of parameters of anterior segment measurement assessment system and optical biometer in predicting lens in implantable collamer lens(ICL)implantation.Methods:This study retrospectively analyzed the examination data of patients who underwent ICL surgery at the department of ophthalmology,Army Characteristic Medical Center from January 2020 to July 2024.The measured data of the chamber corner parameters,which included anterior chamber depth(ACD),central corneal thickness(CCT),white to white(WTW),flat keratometry(K1)and steep keratometry(K2),of 74 patients(134 eyes)who underwent simultaneous measurements of the IOLMaster 700 optical biometer and the Pentacam HR anterior segment measurement assessment system were selected.The expected spherical equivalent(EXP SPH),expected cylinder(EXP CYL),and expected spherical equivalent(EXP SEQ)were calculated,and the differences,correlations and consistencies of these data were analyzed.Results:There were significant differences in ACD,CCT,WTW,K1 and K2 between the IOLMaster 700 and Pentacam HR in measuring myopic patients(t=12.928,6.202,-37.877,-13.743,-12.007,P<0.001).All measured data showed high correlation(r=0.983,0.984,0.961,0.996,0.994,P<0.001).Bland-Altman consistency test showed that the measured values by 3%-6%were outside the limits of 95%consistency,and the differences among the EXP SPH of two instruments and the postoperative actually measured results of spherical lens(SPH),among the EXP CYL of two instruments and the postoperative actually measured results of cylinder lens(CYL),and among the EXP SEQ of two instruments and the postoperative actual measured results of spherical equivalent(SEQ)were statistically significant(x2=20.927,7.451,25.459,P<0.05).The average differences between Pentacam HR and IOLMaster 700 were respectively(0.024±0.491)D and(0.009±.491)D in predicting SPH,and were respectively(-0.05±0.476)D and(-0.049±0.475)D in predicting CYL,and were respectively(-0.001±0.458)D and(-0.016±0.461)D in predicting SEQ.Conclusion:During selection process of ICL surgery for lens,clinicians can reasonably choose Pentacam HR and IOLMaster 700 to calculate lens according to the actual requirements of the patients.
3.Analysis of influencing factors of secondary coagulopathy in patients with severe acute pancreatitis and establishment of prediction model
Yi ZHANG ; Hehua YU ; Tianpeng XU
Tianjin Medical Journal 2025;53(11):1180-1185
Objective To investigate the influencing factors of secondary coagulation dysfunction in patients with severe acute pancreatitis(SAP)and establish the prediction model.Methods A total of 298 SAP patients in our hospital from July 2021 to July 2024 were consecutively selected,and those with secondary coagulation dysfunction were included in the observation group,while those without secondary coagulation dysfunction were included in the control group.Multivariate Logistic regression analysis was employed to investigate the risk factors for secondary coagulation dysfunction in patients with SAP and to establish a multivariate joint prediction model.The receiver operating characteristic curve(ROC)and decision curve were used to evaluate the predictive value of the multivariate joint prediction model for secondary coagulation dysfunction in SAP patients.Results The incidence of secondary coagulation dysfunction in SAP patients was 32.21%.The activated partial thromboplastin time(APTT),prothrombin time(PT)and fibrinogen(FIB)were longer in the observation group than those in the control group(P<0.05).Acute physiological and chronic health score Ⅱ(APACHEⅡ)score,sequential organ failure assessment(SOFA)score,D-dimer,C-reactive protein and albumin were independent influencing factors of secondary coagulation dysfunction in SAP patients(P<0.05).The regression equation model was established according to the results of multivariate analysis screened variables,logit(P)=-24.747+0.363×APACHEⅡ score+0.952×SOFA score-0.449×albumin+1.768×D-dimer+1.004×C-reactive protein,with a good fit.Regression model predicted that the AUC value of secondary coagulation dysfunction in SAP patients was 0.937.Decision curve analysis results showed that the Logistic regression model could achieve the maximum clinical benefit when the threshold probability was in the range of 0.06 to 0.97.Conclusion A comprehensive assessment of influencing factors can comprehensively evaluate the condition of patients and identify patients at high risk of coagulation disorders at an early stage.
4.Analysis of influencing factors of secondary coagulopathy in patients with severe acute pancreatitis and establishment of prediction model
Yi ZHANG ; Hehua YU ; Tianpeng XU
Tianjin Medical Journal 2025;53(11):1180-1185
Objective To investigate the influencing factors of secondary coagulation dysfunction in patients with severe acute pancreatitis(SAP)and establish the prediction model.Methods A total of 298 SAP patients in our hospital from July 2021 to July 2024 were consecutively selected,and those with secondary coagulation dysfunction were included in the observation group,while those without secondary coagulation dysfunction were included in the control group.Multivariate Logistic regression analysis was employed to investigate the risk factors for secondary coagulation dysfunction in patients with SAP and to establish a multivariate joint prediction model.The receiver operating characteristic curve(ROC)and decision curve were used to evaluate the predictive value of the multivariate joint prediction model for secondary coagulation dysfunction in SAP patients.Results The incidence of secondary coagulation dysfunction in SAP patients was 32.21%.The activated partial thromboplastin time(APTT),prothrombin time(PT)and fibrinogen(FIB)were longer in the observation group than those in the control group(P<0.05).Acute physiological and chronic health score Ⅱ(APACHEⅡ)score,sequential organ failure assessment(SOFA)score,D-dimer,C-reactive protein and albumin were independent influencing factors of secondary coagulation dysfunction in SAP patients(P<0.05).The regression equation model was established according to the results of multivariate analysis screened variables,logit(P)=-24.747+0.363×APACHEⅡ score+0.952×SOFA score-0.449×albumin+1.768×D-dimer+1.004×C-reactive protein,with a good fit.Regression model predicted that the AUC value of secondary coagulation dysfunction in SAP patients was 0.937.Decision curve analysis results showed that the Logistic regression model could achieve the maximum clinical benefit when the threshold probability was in the range of 0.06 to 0.97.Conclusion A comprehensive assessment of influencing factors can comprehensively evaluate the condition of patients and identify patients at high risk of coagulation disorders at an early stage.
5.Construction of evaluation indicator system for power system of otolaryngology surgery
Anhai WEI ; Jiaqing YANG ; Anfa LIU ; Mengjia JIA ; Lifen XU ; Fei LI ; Hehua ZHANG
China Medical Equipment 2025;22(11):128-131
Objective:To construct an evaluation indicator system for power system of otolaryngology surgery,so as to provide references for the configuration of surgical power devices of medical institutions.Methods:Literature review and brainstorming were used to analyze existing literature related to surgical power.Combined with expert opinions and clinical demands,an evaluation indicator system was initially proposed.The Delphi method was adopted to determine the evaluation indicators of power system of otolaryngology surgery.The analytic hierarchy process(AHP)method was used to determine the evaluation indicator system of the power system of otolaryngology surgery,which were constructed by weight of each indicator.Results:The evaluation indicator system of power system of otolaryngology surgery included 5 first-level indicators(integrity of medical equipment,products'performance indicators,safety,clinical application effect,and after-sales service guarantee)and 49 second-level indicators under the first-level indicators.In the first-level indicators,equipment's safety had the highest weight(20.48%).In the second-level indicators,the top three of the combined weights were respectively integrity of equipment's main device(7.19%),accessory's integrity(7.03%),and identification's integrity(6.03%).Conclusion:The evaluation index system for otolaryngological surgical power systems clarifies the core dimensions,specific indicators and relative importance of the evaluation,and can be applied to the procurement and selection of surgical power devices in medical institutions,performance testing,clinical effect evaluation and other aspects.
6.Analysis on the accuracy of anterior segment measurement assessment system and optical biometer in predicting lens in ICL implantation
Anhai WEI ; Yangcheng ZOU ; Mengjia JIA ; Anfa LIU ; Hehua ZHANG
China Medical Equipment 2025;22(8):41-45
Objective:To explore the accuracy of parameters of anterior segment measurement assessment system and optical biometer in predicting lens in implantable collamer lens(ICL)implantation.Methods:This study retrospectively analyzed the examination data of patients who underwent ICL surgery at the department of ophthalmology,Army Characteristic Medical Center from January 2020 to July 2024.The measured data of the chamber corner parameters,which included anterior chamber depth(ACD),central corneal thickness(CCT),white to white(WTW),flat keratometry(K1)and steep keratometry(K2),of 74 patients(134 eyes)who underwent simultaneous measurements of the IOLMaster 700 optical biometer and the Pentacam HR anterior segment measurement assessment system were selected.The expected spherical equivalent(EXP SPH),expected cylinder(EXP CYL),and expected spherical equivalent(EXP SEQ)were calculated,and the differences,correlations and consistencies of these data were analyzed.Results:There were significant differences in ACD,CCT,WTW,K1 and K2 between the IOLMaster 700 and Pentacam HR in measuring myopic patients(t=12.928,6.202,-37.877,-13.743,-12.007,P<0.001).All measured data showed high correlation(r=0.983,0.984,0.961,0.996,0.994,P<0.001).Bland-Altman consistency test showed that the measured values by 3%-6%were outside the limits of 95%consistency,and the differences among the EXP SPH of two instruments and the postoperative actually measured results of spherical lens(SPH),among the EXP CYL of two instruments and the postoperative actually measured results of cylinder lens(CYL),and among the EXP SEQ of two instruments and the postoperative actual measured results of spherical equivalent(SEQ)were statistically significant(x2=20.927,7.451,25.459,P<0.05).The average differences between Pentacam HR and IOLMaster 700 were respectively(0.024±0.491)D and(0.009±.491)D in predicting SPH,and were respectively(-0.05±0.476)D and(-0.049±0.475)D in predicting CYL,and were respectively(-0.001±0.458)D and(-0.016±0.461)D in predicting SEQ.Conclusion:During selection process of ICL surgery for lens,clinicians can reasonably choose Pentacam HR and IOLMaster 700 to calculate lens according to the actual requirements of the patients.
7.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.
8.Meta-analysis of application effects of magnetic navigation-guided nasojejunal tube placement in critically ill patients
Hehua YU ; Zhuojuan JIANG ; Wenfang LI ; Qiqi ZHANG ; Jufei DING ; Peipei LEI
China Medical Equipment 2024;21(6):137-142
Objective:To analyze and evaluate the application effect of magnetic navigation-guided nasojejunal tube placement in critically ill patients by literature retrieval.Methods:The Chinese databases of CNKI,Wanfang,VIP and Chinese Biomedical Literature Service System were searched,as well as the literature on randomized controlled trials of magneto-guided nasojejunal tube placement in critically ill patients in foreign language databases of PubMed,CINAHL,Cochrane Library,Web of Science,and Embase,the search period was from January 2000 to September 2023.The literature were screened according to the inclusion and exclusion criteria,and the quality of the literature was evaluated.RevMan 5.4.1 software was used to conduct a meta-analysis of the four outcomes in the literature:success rate of placement,time required for successful placement,time to recovery of vital signs,and patient satisfaction.Results:A total of 7 randomized controlled trials of 7 studies were included,including 4 Chinese studies and 3 English studies,involving 682 patients.The success rate of magnetic navigation-guided nasojejunal tube placement was higher than that of bedside blind nasojejunal tube placement,the difference was statistically significant[OR=4.78,95%CI(2.16~10.58),P<0.0001].The time required for magnetic navigation guided nasojejunal tube placement was less than that of the bedside blind nasojejunal tube placemen,the difference was statistically significant[MD=-12.91,95%CI(-22.93~-2.90,P<0.00001].The time required for recovery of vital signs in patients with magnetic navigation guided nasojejunal tube placement was less than that of the bedside blind nasojejunal tube placemen,the difference was statistically significant[MD=-9.11,95%CI(-12.09~-6.13,P<0.00001].The satisfaction of patients with the magnetic navigation-guided nasojejunal tube placement was higher than that of patients with the bedside blind nasojejunal tube placement,the difference was statistically significant[OR=11.61,95%CI(3.96~34.01),P<0.00001].Conclusion:Compared with bedside blind nasojejunal tube placement,magnetic navigation-guided nasojejunal tube placement can significantly improve the success rate of nasojejunal tube placement in critically ill patients,reduce the time required for successful nasojejunal tube placement,reduce the recovery time of patients'vital signs,and improve patient satisfaction.
9.Discussion on the calibration method of ultrasonic physiotherapy equipment
Chao ZHOU ; Chuandong XIE ; Li YANG ; Hailong SONG ; Senzhong SHI ; Hehua ZHANG
China Medical Equipment 2024;21(9):181-184
Ultrasonic therapy technology is a research hotspot in the field of biomedicine,and the quality control and regulatory requirements for the ultrasonic physiotherapy equipment are also increasing.Based on this,the working principle and structure of ultrasonic physiotherapy equipment were analyzed,and a calibration method of ultrasonic physiotherapy equipment was proposed from the aspects of ultrasonic output power,effective radiation area and acoustic working frequency,etc.,aiming at its main measurement parameters,so as to provide technical reference for its measurement performance evaluation.Two ultrasonic physiotherapy equipment produced by different manufacturers were selected and tested to analyze the calibration results.The results showed that the calibration results were scientific and reasonable,highly operational,and in line with national standards,which can provide technical reference for metrology technical institutions to carry out related work.
10.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.

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