Accuracy of the automated oscillometric home blood pressure monitor braun bua4000 with wide range cuff: validation according to the aami/esh/iso universal standard

Objective: To evaluate the blood pressure (BP) measurement accuracy of the Braun BUA4000 automated oscillometric upper-arm cuff device for self-home use in a 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) and its Amendment 1.2020-01. Design and method: Participants were recruited to fulfil the age, sex, BP, and limb distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. A single wide-range cuff of the test device was used for arm circumference range 22-42 cm. Results: A total of 98 individuals were recruited and 85 were analyzed (mean age 60.3±16.1 [SD] years, 44 men, arm circumference 31.5±5.1 cm, range 22-41.5 cm). For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was 0.9±6.4/-0.3±6.4 mmHg (systolic/diastolic; threshold < = 5±8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual (N = 85) was 5.15/5.81 mmHg (systolic/diastolic; threshold < = 6.88/6.95 mmHg). Conclusions: The Braun BUA4000 automated oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.