Substitute of simulators for human subjects.

At present the overall accuracy of automated sphygmomanometers is assessed in validation studies performed with human subjects with a wide range of blood pressures. These studies permit test devices to be designated as having acceptable or unacceptable accuracy. The feasibility of performing and the statistical rationale for such validation tests under varying circumstances, such as during exercise, and with various subjects, such as the obese, are limited due to the time and money required. Many studies have inadequate quality controls for the reference blood pressure measurements. Simulators have the potential to improve the validation of automated sphygmomanometers, as long as they are able to replay the human biosignals in all their complexity and variability. The simulator developed by the Physikalisch-Technische Bundesanstalt and described in this paper demonstrates that this is feasible, whereas the commercially available devices do not satisfy these requirements, though they are suitable for assessing quality control and for testing reproducibility for manufacturers.