Preliminary study of metrological verification for blood pressure monitor on blood purification equipment
Objective During the actual clinical use of blood pressure monitor on blood purification equipment,there exists the phenomenon that the blood pressure indication fluctuates greatly and the accuracy of blood pressure indication is uncertain. Therefore, this article focuses on metrological verification for blood pressure monitor on blood purification equipment, to evaluate its accuracy in clinical practice. Methods Based on the design principle of blood pressure monitor on blood purification equipment, in accordance with the domestic"verification regulation of non-invasive automated sphygmomanometers:JJG693—2010", and reference to the BHS standard issued by the American Society of Hypertension, as well as the ANSI/AAMI standard jointly issued by the American National Standards Institute and the American Association for the Promotion of Medical Devices,ProSim 8 vital signs simulator is used to measure the blood pressure monitor on blood purification equipment,including blood pressure indication repeatability (systolic pressure, diastolic pressure) and blood pressure indication accuracy (systolic pressure,diastolic pressure).The metrological verification involves 4 types of 2 brands (WEGO Nikkiso and Fresenius Medical Care) ,with a total of 27 blood pressure monitor on blood purification equipment. Results The qualified rate of blood pressure indication repeatability is 100% for blood pressure monitor on blood purification equipment which participating in this study. The accuracy of blood pressure indication tends to decrease with the increase of the standard blood pressure setting value. Different types of blood pressure monitors show their own characteristics in blood pressure type (systolic pressure/diastolic pressure) ,blood pressure indication section and blood pressure indication error value. Also there is a certain proportion of unqualified rate of blood pressure indication accuracy. Conclusions In the actual clinical use,the blood pressure monitor on blood purification equipment has the characteristics of blood pressure indication in good repeatability and some problems in the accuracy. Therefore,it is necessary to pay attention to the regularly metrological verification of blood pressure monitor on blood purification equipment, in order to timely discover the problems in the use of blood pressure monitor and provide equipment and technical assurance for accurate patient blood pressure monitoring in clinical work.