Verification of clinical accuracy of automated non-invasive sphygmomanometers: Is it appropriate to use blood pressure simulators?

Abstract

Cardiovascular diseases are the most common cause of death in developed countries. Blood measurement is an integral part of the diagnosis of these diseases. With the development of oscillometric blood pressure monitors, the question of regular monitoring of their clinical accuracy (overall error) has arisen. This paper deals with the overall accuracy of two commercial tonometers (Hartmann Digital HG 160 comfort and HuBDIC HBP–1520), using two calibrated blood pressure simulators (Fluke BP Pump 2 and Fluke ProSim). Using the Wilcoxon rank-sum test, significant differences between the simulators have been proved for all measurements—both for SBP and DBP measurements and both for Hartmann Digital HG 160 and HuBDIC HBP–1520 tonometers (p < 0.001). Therefore, without the precise knowledge of the relationship between the blood pressure monitor and the simulator used, it is not appropriate to use simulators to determine the overall error. On the other hand, the tested devices had a very good repeatability of the measurements at all presets, with both simulators. From this point of view, it is suitable to use simulators to determine the stability of measurement by a given tonometer rather than its clinical accuracy.