Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in auscultation mode, for clinic use and self-measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010

Abstract

To validate the UEBE Visomat Double Comfort, an upper arm blood pressure monitor, in a general population according to the European Society of Hypertension International Protocol revision 2010. The Visomat Double Comfort is a device designed for self-measurement of blood pressure and for clinical use. The monitor is provided with two operational modalities, a microphonic mode and an oscillometric mode. In this study, the auscultatory modality was tested. Device evaluation was performed in 33 participants with a mean±standard deviation age of 55±20 years (age range 25–88 years). Their systolic blood pressure was 140±28 mmHg, diastolic blood pressure was 87±17 mmHg, and arm circumference was 29±4 cm. The protocol requirements were followed precisely. The device passed all of the requirements fulfilling the standards of the protocol. Mean blood pressure differences between device and observer were −1.1±4.0 mmHg for systolic blood pressure and −0.4±4.1 mmHg for diastolic blood pressure. As the Visomat Double Comfort has achieved the required standards, it is recommended for clinical use in an adult population.