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

Objective 

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.

Methods 

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.

Results 

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.

Conclusion 

As the Visomat Double Comfort in the oscillometric modality has achieved the required standards, it is recommended for clinical use in an adult population.