Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms.

OBJECTIVE: To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol. METHODS: The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard. RESULTS: The mean BP difference between the device and the observers' reference measurements was 1.2 ±â€…2.0 mmHg for systolic BP and 1.0 ±â€…2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ±â€…8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle. CONCLUSIONS: These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm.

Validation of the Hingmed DBP-01P clinical automatic blood pressure monitor provided with wide-range cuff, evaluated in a general population according to the ISO 81060-2:2018 protocol.

To determine the accuracy of the Hingmed DBP-01P monitor for clinical automatic blood pressure (BP) measurement according to the International Organization for Standardization (ISO) 81060-2 2018 protocol. The DBP-01P was tested in 85 subjects from the general population (mean age, 69.9 years; 43 men) using a wide-range cuff for arm circumferences from 17 to 42 cm. The mean device-observer difference was 1.32 ± 3.18 mmHg for SBP and 0.78 ± 3.15 mmHg for DBP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also, criterion 2 was satisfied with the SDs of the 85 participants being well below the maximum values required by the protocol (6.80 and 6.89 mmHg for SBP and DBP pressure, respectively). These data show that the Hingmed BP monitor DBP-01P satisfied the ISO 81060-2:2018 standard requirements for a general population across a wide range of arm sizes using a single wide-range cuff.