Validation of the Omron J7136 and HEM-7361T blood pressure monitors according to the International Organization for Standardization protocol (ISO 81060-2:2018 + Amd.1:2020)

OBJECTIVE: This study aimed to evaluate the accuracy of OMRON J7136 and HEM-7361T oscillometric blood pressure (BP) monitors in the general population according to the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd) 1:2020 standard. METHOD: Subjects were recruited to fulfill the age, gender, BP, and cuff distributions of the ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the OMRON J7136 were used for arm circumference 17-22 cm (small), 22-32 cm (medium), and 32-42 cm (large). A single cuff 17-36 cm was used on the OMRON HEM-7361T. RESULTS: The mean ± SD of the differences between the OMRON J7136 and reference BP readings was -2.14 ± 6.45/-1.43 ± 5.88 mmHg (systolic/diastolic) for criterion 1. The SD of the average BP differences between the OMRON J7136 and reference BP per subject was 5.49/5.36 mmHg (systolic/diastolic) for criterion 2. For the study on the OMRON HEM-7361T, the corresponding values were -2.56 ± 6.35/-3.18 ± 5.67 mmHg (systolic/diastolic) for criterion 1 and 5.33/5.32 mmHg (systolic/diastolic) for criterion 2. CONCLUSION: The OMRON J7136 and HEM-7361T BP monitors both fulfilled the requirements of the ISO Universal Standard (ISO 81060-2:2018/AMD 1:2020) in the general population and can be recommended for self-measurement in adults.