Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in oscillometric 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 designed for self-measurement of blood pressure and for clinical use in a general population according to the European Society of Hypertension International Protocol revision 2010. The device is provided with two operational modalities, a microphonic mode and an oscillometric mode. In this study, the oscillometric modality was tested. Device evaluation was performed in 33 participants with a mean ± standard deviation age of 56.3 ± 20.0 years (range, 25-85 years). Their systolic blood pressure was 140.4 ± 27.7 mmHg, diastolic blood pressure was 86.8 ± 17.2 mmHg, and arm circumference was 29.3 ± 3.9 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 -0.9 ± 4.1 mmHg for systolic blood pressure and -0.1 ± 3.3 mmHg for diastolic blood pressure. As the Visomat Double Comfort in the oscillometric modality has achieved the required standards, it is recommended for clinical use in an adult population.