PDF(Pubmed)
Abstract：
This study aimed to validate the accuracy of DBP-6279B, an automated inflationary oscillometric upper-arm blood pressure (BP) monitor, in the sitting position according to the AAMI/ESH/ISO (81060-2 : 2018 + Amd.1 : 2020) universal standard protocol. SBPs and DBPs were measured simultaneously on the same arm in 88 adults (female : male = 47 : 41) with a mean age of 56.85 years using a mercury sphygmomanometer (two observers) and a DBP-6279B device (one supervisor). The AAMI/ESH/ISO 81060-2 : 2018 and Amd.1 : 2020 universal standards for the validation of BP-measuring devices in adults and adolescents were followed. A total of 259 valid pairs of data were used in the analysis. According to Criterion 1, the mean difference of SBP between the test device (DBP-6279B) and the reference device (the mercury sphygmomanometer) was 0.75 mmHg, with a SD of 7.66 mmHg. The mean difference in DBP was 1.13 mmHg, with a SD of 6.14 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 0.85 mmHg, and the SD was 6.56 mmHg, which was less than 6.88 mmHg and met the requirements. The mean difference in DBP was 1.27 mmHg, and the SD was 5.42 mmHg, which was less than 6.82 mmHg and met the requirements. DBP-6279B fulfilled the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018 + Amd.1 : 2020); hence, it can be recommended for both clinical and self/home BP measurement in adults and adolescents.
摘要：
本研究旨在验证DBP-6279B的准确性，自动膨胀示波上臂血压（BP）监测仪，根据AAMI/ESH/ISO（81060-2：2018+Amd.1：2020）通用标准协议，坐在坐姿中。使用水银血压计（两名观察者）和DBP-6279B设备（一名主管）在88名平均年龄为56.85岁的成年人（女性：男性=47：41）的同一手臂上同时测量了SBP和DBP。遵循AAMI/ESH/ISO81060-2:2018和Amd.1:2020成人和青少年BP测量设备验证通用标准。在分析中总共使用了259对有效数据。根据标准1，试验装置（DBP-6279B）和参考装置（水银血压计）之间的SBP平均差为0.75mmHg，SD为7.66mmHg。DBP的平均差异为1.13mmHg，SD为6.14mmHg。SBP和DBP的平均差异均小于5mmHg，SD小于8mmHg,符合要求。根据标准2，测试装置与参考装置之间的SBP平均差为0.85mmHg，SD为6.56mmHg，小于6.88mmHg，符合要求。DBP的平均差异为1.27mmHg，SD为5.42mmHg，小于6.82mmHg，符合要求。DBP-6279B符合AAMI/ESH/ISO通用标准（ISO81060-2:2018+Amd.1:2020）的要求；因此，可推荐用于成人和青少年的临床和自我/家庭BP测量.
