Validation of the Omron HEM-7380T (HCR-7728T) blood pressure monitor in the general population according to the international organization for standardization 81060-2:2018 + Amd.1:2020 and Amd.2:2024

OBJECTIVE: This study aimed to validate the accuracy of Omron HEM-7380T (HCR-7728T), an automated deflationary oscillometric upper-arm blood pressure (BP) monitor, according to the international organization for standardization (ISO) 81060-2 : 2018 + Amd1 : 2020 and Amd2 : 2024 protocols (ISO standards). METHODS: Accuracy was assessed by alternately measuring systolic BP (SBP) and diastolic BP (DBP) in the same arm using the test device and a mercury sphygmomanometer. All participants met the inclusion criteria outlined in the protocol. RESULTS: A total of 85 patients were included (43 males and 42 females), with a mean age of 63.9 ± 10.3 years and a mean arm circumference of 26.7 ± 5.4 cm. Regarding Criterion 1, the mean ± SD of the differences between the test device and reference BP was 0.1 ± 6.85 mmHg for SBP and 0.9 ± 5.41 mmHg for DBP, fulfilling the ISO requirement of less than or equal to 5 ± less than or equal to 8 mmHg. For Criterion 2, the SD values were 0.1 ± 5.69 mmHg for SBP and 0.9 ± 4.95 mmHg for DBP, satisfying the required thresholds of less than or equal to 6.95and less than or equal to 6.88, respectively. The results indicated that this device conforms to the ISO standards. CONCLUSION: Omron HEM-7380T fulfilled criteria 1 and 2 of the protocol. Therefore, the device is considered sufficiently accurate for BP measurements in the general population.