Objective: This study aims to evaluate the accuracy of the Omron HBP-1320 electronic blood pressure (BP) monitor for ambulatory BP measurement in both pediatric and adult populations according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) (ISO 81060-2:2018/Amd 1:2020) protocol.
Methods: Subjects who met age, gender, BP, and cuff distribution criteria specified by the AAMI/ESH/ISO (ISO 81060-2:2018/Amd1:2020) protocol were recruited for this study. BP measurements were performed using the same-arm sequential measurement method. The test device was equipped with cuffs suitable for arm circumferences ranging from 12.0 to 42.0 cm.
Results: A total of 87 participants were initially recruited, with 85 (35 children and 50 adults) included in the final analysis after excluding two participants. The mean age of all participants was 38.1 ± 28.98 years, with children averaging 6.7 ± 2.23 years and adults 60.1 ± 15.39 years. For validation criterion 1, the mean ± SD of differences between the test device and reference BP measurements was 2.3 ± 5.47 mmHg for SBP and 1.3 ± 5.65 mmHg for DBP. Both mean differences were ≤5 mmHg, and SDs ≤ 8 mmHg, meeting the criterion. For validation criterion 2, the mean differences were 2.3 ± 3.93 mmHg for SBP and 1.3 ± 5.13 mmHg for DBP, satisfying the thresholds of ≤6.55 mmHg for SBP and ≤6.82 mmHg for DBP.
Conclusion: The Omron HBP-1320 electronic BP monitor meets the requirements of the AAMI/ESH/ISO (ISO 81060-2:2018/Amd 1:2020) validation standard for adults and children.
扫码关注我们
求助内容:
应助结果提醒方式:
