Ps-c10-7: a novel professional automated auscultatory blood pressure monitor for office use with visual display of korotkoff sounds: inbody bpbio480kv validation

Objective: A novel professional automated auscultatory upper arm-cuff blood pressure (BP) monitor (InBody BPBIO480KV) for use in the office or clinic by healthcare professionals was developed. The device records the Korotkoff sounds using an electronic stethoscope embedded to the cuff, which are reproduced and graphically displayed on the device screen during cuff deflation, and automatically interpreted to report systolic and diastolic BP values. This validation study assessed the accuracy of the device 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) and the ISO Amendment 1.2020-01. Design and Method: Subjects were recruited to fulfil the age, gender, BP, arm size and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 23–28, 28–35 and 33–42 cm. Results: A total of 108 subjects were recruited and 85 were analyzed (mean age 57.3 ± 15.0 [SD] years, 53 men, arm circumference 32.1 ± 5.1 cm, range 23–42 cm). For validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings (N = 255) was 0.3 ± 5.5/0.6 ± 4.7 mmHg (systolic/diastolic; pass 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 3.76/3.61 mmHg (systolic/diastolic; pass threshold < = 6.95/6.91 mmHg). Conclusions: The InBody BPBIO480KV professional automated auscultatory BP device for office use comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) in general population and can be recommended for clinical use in adults.