Validation of Omron HEM-9200T, a home blood pressure monitoring device for the upper arm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol

Abstract

The performance of Omron HEM-9200T for monitoring blood pressure (BP) in the upper arm was validated in accordance with the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. The device was assessed by using it on 87 participants who fulfilled the inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP provided by the protocol. Validation and data analysis were performed according to the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± standard deviation of the differences between the test device and reference BP was −0.1 ± 5.06/1.2 ± 5.8 mmHg (systolic/diastolic). The mean differences between the two observers and Omron HEN-9200T were −0.1 ± 3.82 mmHg for systolic BP and 1.2 ± 5.34 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤6.91 for SBP and ≤6.87 for DBP. These two ANSI/AAMI/ISO criteria were fulfilled.

The Omron HEM-9200T BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for BP measurements at home in the general population.