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

• Published in: Vascular health and risk management 2020-01, Vol.16, p.571-575
• Main Authors: Takahashi, Hakuo, Saito, Kanako
• Format: Article
• Language: English
• Subjects: Accuracy; Adult; Aged; Arm - blood supply; Auscultation; Blood Pressure; Blood Pressure Determination - instrumentation; Blood Pressure Determination - standards; blood pressure monitoring device; Cardiac arrhythmia; Female; Health care; Humans; Hypertension; International organizations; ISO standards; Male; Materials Testing; Middle Aged; Observer Variation; Original Research; Predictive Value of Tests; Pressure distribution; Pressure measurement; protocol; Reproducibility of Results; validation; Young Adult
• ISSN: 1178-2048; 1176-6344; 1178-2048
• DOI: 10.2147/VHRM.S287016

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. 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. 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. The OMRON HEM-1040 BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard.