Validation of a Novel Professional Automated Auscultatory Blood Pressure Monitor Korot V2 Doctor in General Population According to the Aami/Esh/Iso Universal Standard

Objective: A novel automated auscultatory upper arm-cuff blood pressure (BP) monitor KOROT V2 Doctor was developed for professional use. This device is equipped with an electronic stethoscope integrated into the cuff to enable recording of Korotkoff sounds. These auditory signals are graphically displayed during the deflation process, offering to the healthcare professionals a visual tool for assessing the quality of each automated reading. The device was validated 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, arm circumference and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35 and 33-42 cm. Results: Data from 85 individuals were analyzed (mean age 56.4±16.0 [SD] years, 50 men, arm circumference 23-42 cm). For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N=255) was -1.3±6.0/1.5±5.0 mmHg (systolic/diastolic; threshold <= 5±8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N=85) was 4.61/3.48 mmHg (systolic/diastolic; threshold <= 6.82/6.78 mmHg). Conclusions: The KOROT V2 Doctor electronic device developed for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably 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. This novel device offers potential additional advantages for clinical practice, as it simulates the gold standard manual auscultatory method and allows healthcare professionals to visually assess Korotkoff sounds during each measurement, allowing the rejection of poor-quality readings.