Objective: To assess the accuracy of the iHealth oscillometric ambulatory blood pressure (BP) monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard.
Methods: Adults were recruited to fulfil the age, sex, BP and cuff distribution criteria of the ANSI/AAMI/ISO standard using the same-arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-34 and 30-42 cm.
Results: A total of 100 individuals were recruited and 85 were included in the analysis. For validation criterion 1, the mean±SD of the differences between the test device and reference BP was -0.7±6.0/0.7±4.8 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference per participant was 4.72/3.97 mmHg (systolic/diastolic).
Conclusion: The iHealth ambulatory BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard in adults and can be recommended for clinical use.