A procedure to determine the accuracy of the blood pressure simulator

To be used in the diagnosis and monitoring of hypertension, automatic sphygmomanometers must undergo clinical investigation. This is a time-consuming and costly process, which is why it is not conducted for every manufactured sphygmomanometer. In this context, blood pressure simulators can serve as an alternative, provided there is a way to ascertain their accuracy and this article addresses that situation.

Utilizing statistical concepts associated with proficiency tests (ISO 13528:2015), a procedure was developed to determine the accuracy of simulators based on the oscillometric method.

The procedure was evaluated through a simulation involving 100,000 iterations.

The results indicate that the procedure is suitable, enabling its use for evaluating the measurement error of automatic sphygmomanometers.