Accuracy of the OMRON M2 Intelli IT+ (HEM-7146T2-EBK) device for self-blood pressure measurements in children and adult populations according to the International Organization for Standardization Universal Standard (ISO 81060-2:2018/AMD 2:2024) proto

OBJECTIVE: This study aimed to assess the accuracy of the OMRON M2 Intelli IT+ (HEM-7146T2-EBK) brachial device for BP measurement in children and adults, according to the International Organization for Standardization (ISO) 81060-2:2018/AMD 2:2024 Standard. METHODS: OMRON M2 Intelli IT+ is an oscillometric device designed to measure BP at the brachial level. This study adhered to the ISO 81060-2:2018/AMD 2:2024 protocol and employed the same arm sequential BP measurement method. A total of 85 participants meeting the protocol-specified age, sex, BP, and cuff distribution criteria were included. The accuracy analysis utilized criterion 1 and criterion 2 defined in the ISO protocol. RESULTS: Eighty-seven individuals were selected; two were excluded because of high BP variability ( n = 1) and arrhythmia ( n = 1). Eighty-five participants (50 adults and 35 children) were included. Mean BP differences between the observer measurements were -0.1 ± 2.1/0.5 ± 1.9 mmHg [systolic BP (SBP)/diastolic BP (DBP)]. In the children and adult population ( n = 85), criterion 1, the mean BP differences between the reference measurements and the device were -2.1 ± 4.4/-0.3 ± 3.7 mmHg for SBP and DBP (≤5 ± 8 mmHg); criterion 2 was 3.1/2.9 mmHg for SBP and DBP (≤6.62/6.95 mmHg). In the children's population ( n = 35), criterion 1 values were -3.7 ± 4.0/-1.1 ± 4.1 mmHg for SBP and DBP (≤5 ± 8 mmHg). CONCLUSION: The OMRON M2 Intelli IT+ (HEM-7146T2-EBK) device meets the requirements of the ISO 81060-2:2018/AMD 2:2024 protocol, supporting its use in children and adults for home BP monitoring.