Validation of the DBP-20I Monitor for Self Blood Pressure Measurement According to the Universal Protocol
Objective: To determine the accuracy of the Hingmed DBP-20i monitor, a device intended for oscillometric self blood pressure (BP) measurement according to the new ISO81060-2 2018/Amd 1/ Amd 2 (Universal) protocol.
Methods: The DBP-20i monitor was tested in 90 subjects from the general population aged from 19 to 78 years (mean 41 years). The device was provided with a single wide-range cuff suitable for arm circumferences ranging from 17 to 42 cm. The validation was carried out performing sequential same-arm measurements strictly following the universal protocol.
Results: The mean device–observer difference was 3.71±3.44 mmHg for systolic BP and 3.21±3.54 mmHg for diastolic BP. Both mean and standard deviations were below the maximum values required by the protocol (≤ 5 ± 8 mmHg) and thus criterion 1 was satisfied. The device performance satisfied also criterion 2 of the protocol being the standard deviations (3.38/3.45 mmHg) well below those required by the protocol (5.83/6.03 mmHg).
Conclusions: The Hingmed DBP-20i device satisfied the ISO 81060-2:2018/Amd 1/Amd 2 standard requirements for a general population study and is suitable for BP measurement in people with arm size ranging from 17 to 42 cm.