Validating the accuracy of Omron HEM-790XT1 electronic blood pressure monitor in the general population according to AAMI/ESH/ISO (ISO 81060-2:2018 + AMD1:2020).

IF 2.3 4区医学

Blood Pressure Pub Date : 2026-12-01 Epub Date: 2026-06-17 DOI:10.1080/08037051.2026.2682038

Minghui Gong, Yang Yu, Yingying Chen, Jing Li, Jiayu Su, Yannan Huang, Kai Zhong, Jing Zhang, Yuta Teruyama, Ying Zhang, Yinong Jiang, Wei Song

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Abstract

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.

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根据AAMI/ESH/ISO （ISO 81060-2:2018 + AMD1:2020）验证欧姆龙hm - 790xt1电子血压计在普通人群中的准确性。

背景：根据国际AAMI/ESH/ISO （ISO 81060-2:2018 + AMD1:2020）标准，验证欧姆龙hm - 790xt1自动振荡上臂血压（BP）监测仪在普通成人中的准确性。方法：招募符合年龄、性别、血压范围和臂围分布等具体标准的成人受试者。血压由两名训练有素的观测者使用同臂顺序法测量。测试装置在膨胀阶段测量血压，并与标准水银血压计的读数进行比较。测试装置与其标准袖带一起使用，验证臂围范围为22cm-32cm。结果：剔除2名受试者后，最终分析共纳入85名受试者。平均年龄35±13.7岁，男性占35.29%，女性占64.71%。根据标准1（所有个体配对读数），试验与参考装置的收缩压（SBP）均值差±标准差为-1.09±4.94 mmHg，舒张压（DBP）均值差为-2.49±4.97 mmHg，满足≤5±8 mmHg的要求。根据标准2（每位参与者的平均值），试验与参考装置之间的平均差值±标准偏差为收缩压-1.09±3.81 mmHg，舒张压-2.49±4.12 mmHg。收缩压和舒张压的标准差分别低于6.86 mmHg和6.47 mmHg的导出阈值。欧姆龙HEM-790XT1自动振荡式血压监测仪在收缩压和舒张压测量方面与水银血压计表现出令人满意的一致性。结论：欧姆龙hm - 790xt1自动振荡上臂血压监测仪满足AAMI/ESH/ISO （ISO 81060-2:2018 + AMD1:2020）标准的所有验证标准，可推荐用于验证臂围范围内成人的准确血压测量。

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来源期刊

Blood Pressure Medicine-Cardiology and Cardiovascular Medicine

CiteScore

3.20

自引率

5.60%

发文量

期刊介绍： For outstanding coverage of the latest advances in hypertension research, turn to Blood Pressure, a primary source for authoritative and timely information on all aspects of hypertension research and management. Features include: • Physiology and pathophysiology of blood pressure regulation • Primary and secondary hypertension • Cerebrovascular and cardiovascular complications of hypertension • Detection, treatment and follow-up of hypertension • Non pharmacological and pharmacological management • Large outcome trials in hypertension.