Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol

The present study aimed to evaluate the accuracy of the Omron HBP-9031C automated oscillometric upper-arm blood pressure (BP) measurement device for professional office BP monitoring, according to the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) in the general population. The device was assessed by using it on 85 participants, who fulfilled our inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP. The validation and data analysis were performed as per the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± SD of the differences between the test device and reference BP was 1 ± 8/−2 ± 6 mmHg (systolic/diastolic). The mean differences between the two observers and the Omron HBP-9031C were 1 ± 7 mmHg for systolic BP and −2 ± 6 mmHg for diastolic BP, according to criterion 2. The two ANSI/AAMI/ISO criteria were fulfilled. The OMRON HBP-9031C professional BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for clinical use.