Department of Medicine and Surgery, Villa Maria Hospital.
Department of Medicine, Studium Patavinum, University of Padova, Padova, Italy.
Blood Press Monit. 2024 Jun 1;29(3):144-148. doi: 10.1097/MBP.0000000000000696. Epub 2024 Feb 23.
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.
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.
The mean BP difference between the device and the observers' reference measurements was 1.2 ± 2.0 mmHg for systolic BP and 1.0 ± 2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 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.
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.
根据 ISO81060-2:2018 协议，确定 KOROT P3 Accurate（前身为 InBody BPBIO480KV）监测器的准确性，这是一种专为专业用途开发的自动听诊血压（BP）测量设备，适用于臂围较大的人群。
使用柯氏音法水银血压计和 20cm×40cm 的筒状带测臂围从>42cm 到 53cm 的 37 名受试者，将柯氏音法水银血压计作为参考标准，对 KOROT P3 Accurate 进行测试。
设备与观察者参考测量值之间的平均 BP 差值为收缩压 1.2±2.0mmHg，舒张压 1.0±2.0mmHg。这些数据符合协议标准要求的标准 1（≤5±8mmHg）。同时，标准 2 也得到了满足，收缩压的标准偏差为±1.7mmHg，舒张压的标准偏差为±1.6mmHg，远低于协议要求的最大值（±6.84/6.87mmHg）。设备与参考收缩压和舒张压差值的散点图显示，在参与者的 BP、臂围和上臂倾斜角度的范围内，设备具有相似的准确性。
这些数据表明，KOROT P3 Accurate 监测器在臂围从>42cm 到 53cm 的特殊人群中，满足 ISO 81060-2:2018 标准要求。
