Objective: The aim of this study was to validate the UA-1200BLE device using the ISO 81060-2:2013 standard.
Materials and methods: Individuals aged more than 12 years were recruited from among the outpatients and volunteers of Jichi Medical University (Tochigi, Japan). Eighty-five patients were included in the final analyses. Validation was performed using the same-arm sequence protocol as per the ISO 81060-2:2013 standard.
Results: The device performed well against the standard; the mean and SD values for the differences between device and observed systolic and diastolic blood pressure values fulfilled both criterion 1 and criterion 2 of the standard (criterion 1: -2.62±6.89 and -0.90±6.63 mmHg, respectively; criterion 2: -2.65±5.36 and -0.91±6.12 mmHg, respectively). The Bland-Altman plots did not show any systematic variation in the error.
Conclusion: The UA-1200BLE device had a high level of accuracy and fulfilled all ISO 81060-2:2013 standard requirements in adults with a wide range of arm circumference measurements. It is therefore suitable as a wireless blood pressure monitoring tool in patients with hypertension.