Validation of the iHealth ambulatory blood pressure monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization standard


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Abstract

ObjectiveTo 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.MethodsAdults 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.ResultsA 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).ConclusionThe iHealth ambulatory BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard in adults and can be recommended for clinical use.

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