Validating the accuracy of Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure according to the ISO 81060-2:2018+Amd 1:2020 protocol in the general population

Abstract

Purpose: The performance of the Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018 (E) and amendment (Amd)1:2020 protocol.

Methods: The device was used to assess 98 participants who fulfilled the inclusion criteria, including the range of arm circumference and systolic and diastolic BP, in accordance with the protocol. Data validation and analysis were performed according to the manufacturer's instructions.

Results: In the ISO validation procedure (criterion 1), the mean ± SD of the differences between test device readings and reference BP was 0.3 ± 6.17/3.6 ± 5.26 mmHg (systolic/diastolic). These data fulfilled the ISO requirements of ≤5±≤8 mmHg. The mean differences between the observer measurements and Omron HEM-7372T1-AZAZ (BP5460) readings were 0.3 ± 4.82 mmHg for systolic BP and 3.6 ± 4.78 mmHg for diastolic BP, fulfilling criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP. Therefore, two ISO criteria were fulfilled.

Conclusion: The Omron HEM-7372T1-AZAZ BP monitor fulfilled the requirements of the ISO validation standard. This device can be recommended for home BP measurements in the general population.