Validation of the Omron HBP-1320 for professional use according to the ANSI/AAMI/ISO 81060-2: 2013 protocol and the 2010 revision of the European Society of Hypertension International Protocol.

Abstract

Performance of the Omron HBP-1320, designed for professional use by adding several features to the home blood pressure (BP) measuring device, was validated using two different protocols, specifically the ANSI/AAMI/ISO 81060-2:2013 (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol, 2010 Revision (ESH IP2), as a separate study. Three trained medical technologists validated the performance of this device by comparing data obtained from the device with those obtained using a standard mercury sphygmomanometer throughout the study. Mean differences in mercury readings for systolic BP (SBP) and diastolic BP (DBP) between the devices were 1.6 ± 5.8 and -0.4 ± 5.3 mmHg, respectively, according to the ANSI/AAMI/ISO protocol, and mean device-observer measurement differences were -0.4 ± 4.9 and -0.2 ± 4.2 mmHg, respectively, satisfying Part 1 of ESH IP2. Differences in SBP and DBP both satisfied Part 2 of ESH IP2. The number of absolute differences in the values obtained using the device and those obtained by the observers fulfilled the requirements of the ANSI/AAMI/ISO protocol and ESH IP2. Omron HBP-1320 met all requirements of the ANSI/AAMI/ISO protocol and ESH IP2.