Abstract：
OBJECTIVE: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy.
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) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill 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 (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills 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.
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) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill 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 (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills 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.
摘要：
目的：开发了一种新型的自动听诊上臂袖带血压（BP）监测仪KOROTV2Doctor（InBodyBPBIO280KV）供专业使用。嵌入在设备袖带中的电子听诊器记录科罗特科夫的声音，在放气期间以图形方式显示，允许医疗保健专业人员进行视觉评估。该设备提供自动测量BP和这项研究评估其准确性。
方法：应用了医疗器械促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）通用标准（ISO81060-2：2018）及其修正案1.2020-01的要求。参与者被招募来满足年龄，性别,BP,臂围,和通用标准及其修正案的袖带分布标准在一般人群中使用相同的手臂顺序测量方法。测试装置的三个袖口的臂周长23-28、28-35和33-42cm进行测试。
结果：分析了来自85个人的数据[平均年龄：56.4±16.0（SD）岁，50个人,手臂周长23-42厘米]。对于验证标准1,试验装置和参考BP读数(N=255)之间的平均差±SD为-1.3±6.0/1.5±5.0mmHg(收缩压/舒张压;阈值≤5±8mmHg)。对于标准2，每个个体（N=85）的平均BP差异的SD为4.61/3.48mmHg（收缩压/舒张压；阈值≤6.82/6.78mmHg）。
结论：专业使用的KOROTV2Doctor（InbodyBPBIO280KV）设备，它提供了自动听诊测量与科罗特科夫声音的视觉显示，在一般人群中舒适地满足AAMI/ESH/ISO通用标准（ISO81060-2:2018）的所有要求，可推荐用于临床。
方法：应用了医疗器械促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）通用标准（ISO81060-2：2018）及其修正案1.2020-01的要求。参与者被招募来满足年龄，性别,BP,臂围,和通用标准及其修正案的袖带分布标准在一般人群中使用相同的手臂顺序测量方法。测试装置的三个袖口的臂周长23-28、28-35和33-42cm进行测试。
结果：分析了来自85个人的数据[平均年龄：56.4±16.0（SD）岁，50个人,手臂周长23-42厘米]。对于验证标准1,试验装置和参考BP读数(N=255)之间的平均差±SD为-1.3±6.0/1.5±5.0mmHg(收缩压/舒张压;阈值≤5±8mmHg)。对于标准2，每个个体（N=85）的平均BP差异的SD为4.61/3.48mmHg（收缩压/舒张压；阈值≤6.82/6.78mmHg）。
结论：专业使用的KOROTV2Doctor（InbodyBPBIO280KV）设备，它提供了自动听诊测量与科罗特科夫声音的视觉显示，在一般人群中舒适地满足AAMI/ESH/ISO通用标准（ISO81060-2:2018）的所有要求，可推荐用于临床。
