Accuracy of the WBP-02A Device for Ambulatory Blood Pressure Measurement According to the Universal Protocol
Objective: To determine the accuracy of the Hingmed WBP-02A monitor, an ambulatory blood pressure monitoring device, according to the new ISO81060-2 2018/Amd 1/Amd 2 (Universal) protocol.
Methods: The WBP-02A device was tested in 95 subjects from the general population using four cuffs of different size and in 36 subjects who underwent a bicycle ergometric test.
Results: In the general population, the mean device–observer blood pressure difference was 3.98±3.77 mmHg for systolic blood pressure and 3.53±3.37 mmHg for diastolic blood pressure. The mean and standard deviation were below the maximum values required by the protocol (≤ 5 ± 8 mmHg) and thus criterion 1 was satisfied. Also criterion 2 of the protocol was satisfied being the standard deviations (3.71/3.31 mmHg) well below those required by the protocol (5.64/5.97 mmHg). During the ergometric test the mean device–observer difference was 3.84±2.97 mmHg for systolic blood pressure and 3.30±3.06 mmHg for diastolic blood pressure satisfying the protocol requirement. Conclusions: The WBP-02A monitor satisfied the ISO 81060-2:2018/Amd 1/Amd 2 standard requirements for a general population study and also the protocol criterion for ambulatory blood pressure monitoring devices.