Validation of the Omron HEM-1040 Blood Pressure Monitor According to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 Protocol

• Main Authors: Takahashi H, Saito K
• Format: Article
• Language: English
• Published: Dove Medical Press 2020-12-01
• Series: Vascular Health and Risk Management
• Subjects: blood pressure monitoring device; accuracy; protocol; standard; validation
• Online Access: https://www.dovepress.com/validation-of-the-omron-hem-1040-blood-pressure-monitor-according-to-t-peer-reviewed-article-VHRM

Hakuo Takahashi,1 Kanako Saito2 1Department of Cardiology, Biwako Central Hospital, Otsu City, Shiga 520-0834, Japan; 2Department of Technology Development, Omron Healthcare Co., Ltd, Mukou City, Kyoto, JapanCorrespondence: Hakuo TakahashiDepartment of Cardiology, Biwako Central Hospital, 1-21-27, Hieidaira, Otsu City, Shiga 520-0016, JapanTel [phone]Fax [phone]Email [e-mail]: The accuracy of the Omron HEM-1040 automated oscillometric upper-arm blood pressure (BP) monitoring device, designed for home self-measurements in adult populations, was tested according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060– 2:2013 protocol.Methods: The requirements of this protocol were precisely followed with the recruitment of 85 individuals in whom sequential systolic BP (SBP) and diastolic BP (DBP) were measured in the same (left) arm and who fulfilled the inclusion criteria involving the ranges of arm circumference, SBP, and DBP.Results: The mean device-observer difference in the 255 separate pairs of BP data was − 2.7 ± 7.14 mmHg for SBP and − 3.3 ± 5.70 mmHg for DBP. The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060– 2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 85 participants was − 2.7 ± 5.89 mmHg for SBP and − 3.3 ± 4.99 mmHg for DBP, fulfilling criterion 2 with a standard deviation of ≤ 6.39 mmHg for SBP and ≤ 6.09 mmHg for DBP.Conclusion: The OMRON HEM-1040 BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard.Keywords: blood pressure monitoring device, accuracy, protocol, standard, validation