Validation of the Omron HBP-9031C blood pressure monitor for clinics and hospitals according to the ANSI/AAMI/ISO 81060-2:2013 protocol

Abstract

Objective: The present study aimed to evaluate the accuracy of the Omron HBP-9031C automated oscillometric upper-arm blood pressure (BP) measurement device for blood pressure monitoring, according to the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO). Participants and Method: The device evaluations were performed in 85 participants, who fulfi lled the inclusion criteria of the protocol. The validation procedure and data analysis followed the protocol precisely. Results: 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 0.5 ± 7.84/-1.9 ± 6.30 mmHg (systolic/diastolic). The mean differences between the two observers and the Omron HBP-9031C were 0.5 ± 6.69 mmHg (range, −18 to 15 mmHg) for systolic BP and-1.9 ± 5.63 mmHg (range, −17 to 14 mmHg) for diastolic BP, according to criterion 2. The two criteria of the ANSI/AAMI/ISO were fulfi lled. Conclusion: The professional OMRON BP monitor, HBP-9031C fulfi lled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for clinical use.