Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol in the general population without arrhythmias.

Abstract

The present study aimed to evaluate the accuracy of the Omron HEM-7600T automated oscillometric upper-arm blood pressure (BP) monitor 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. We recruited individuals until we obtained 86 eligible participants whose BP levels and ranges of arm circumference met the BP distribution requirements specified by the ANSI/AAMI/ISO. In each individual, we sequentially measured systolic and diastolic blood pressures (DBPs) using a mercury sphygmomanometer (two observers) and the HEM-7600T device (one supervisor) in the left upper arm. Data analysis was performed according to the ANSI/AAMI/ISO guidelines. A total of 101 individuals were recruited, and 86 were finally included in the analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP was -0.6 ± 6.6/1.0 ± 6.5 mmHg (systolic/diastolic). 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 86 participants was -0.6 ± 5.65 mmHg for systolic blood pressure and 1.0 ± 5.96 mmHg for DBP, fulfilling criterion 2 with an SD of ≤6.91 mmHg for systolic blood pressure and ≤6.87 mmHg for DBP. The Omron HEM-7600T BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation protocol in adults and can be recommended for home BP measurements.