Minghui Gong, Y S Yang, Yingying Chen, Jing Li, Jiayu Su, Yannan Huang, Kai Zhong, 张静 Jing ZHANG, Teruyama Yuta, Y Zhang, Y N Jiang, Wei Song
BACKGROUND: Validation of the accuracy of the Omron HEM-790XT1 automatic oscillometric upper-arm blood pressure (BP) monitor in the general adults according to the international AAMI/ESH/ISO (ISO 81060-2:2018 + AMD1:2020) standard. METHODS: Eligible adult participants meeting the protocol-specific criteria for age, gender, BP range and arm circumference distribution were recruited. The BP was measured by two trained observers using the same-arm sequential method. The test device measured BP during the inflation phase and was compared with readings from a standard mercury sphygmomanometer. The test device was used with its standard cuff, validated for an arm circumference range of 22-32 cm. RESULTS: A total of 85 participants were included in the final analysis after excluding 2 participants. The average age was 35 ± 13.7 years, with males accounting for 35.29% and females for 64.71%. According to Criterion 1 (all individual paired readings), the mean difference ± standard deviation (SD) between the test and reference device was -1.09 ± 4.94 mmHg for systolic blood pressure (SBP) and -2.49 ± 4.97 mmHg for diastolic blood pressure (DBP), meeting the requirement of ≤5 ± 8 mmHg. According to Criterion 2 (average per participant), the mean difference ± SD between the test and reference device was -1.09 ± 3.81 mmHg for SBP and -2.49 ± 4.12 mmHg for DBP. Both the SDs for SBP and DBP were below the derived thresholds of 6.86 and 6.47 mmHg, respectively. The Omron HEM-790XT1 automatic oscillometric BP monitor demonstrated satisfactory consistency with the mercury sphygmomanometer in both SBP and DBP measurements. CONCLUSIONS: The Omron HEM-790XT1 automatic oscillometric upper-arm BP monitor satisfied all validation criteria of the AAMI/ESH/ISO (ISO 81060-2:2018 + AMD1:2020) standard and can be recommended for accurate BP measurement in adults within the validated arm circumference range.