Validation of the novel professional automated auscultatory upper-arm cuff blood pressure monitor KOROT V2 Doctor (KOROT P2) in a pediatric population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018)

Objective The novel automated auscultatory upper arm-cuff blood pressure (BP) monitor KOROT V2 Doctor (KOROT P2) has been successfully validated for professional use in the general population with three cuff sizes (23–28, 28–35, and 33–42 cm). The device provides automated measurements of BP using an electronic stethoscope embedded in the cuff, which records and displays Korotkoff sounds during deflation, allowing visual assessment by the healthcare professional. The device is also equipped with pediatric cuffs, and this study aimed to evaluate the device’s accuracy in children. Methods The requirements of 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) were applied. Three cuffs of the test device were tested for arm circumference 15–18, 18–23, and 23–28 cm. Results Data from 35 individuals were analyzed [mean age: 8.7 ± 2.2 (SD) years, 18 boys, arm circumference: 15.1–28 cm]. For Validation Criterion 1, the mean difference ±SD between the test device and reference BP readings ( N = 105) was 0.7 ± 5.1/0.4 ± 6.2 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Validation Criterion 2, the SD of the averaged BP differences between the test and reference BP readings per individual was 3.92/4.78 mmHg (systolic/diastolic; threshold ≤6.90/6.93 mmHg). Conclusion The KOROT V2 Doctor (KOROT P2) device 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 pediatric population and can be recommended for clinical use.