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Objective

To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2: 2018).

Methods

Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22–32 (medium) and 32–42 cm (large).

Results

One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean±SD of the differences between the test device and reference BP readings was 0.9±6.9/0.5±5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of …