Validation of the oscillometric home blood pressure monitor Braun BUA4000 with wide-range cuff 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

ObjectiveTo 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.MethodsParticipants were recruited to fulfill the age, sex, BP and limb circumference distribution criteria of the AAMI/ESH/ISO Universal Standard in a 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.ResultsA 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).ConclusionThe Braun BUA4000 automated oscillometric BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard in a general population and can be recommended for self-monitoring of BP by patients at home.