PDF(Pubmed)
Abstract：
To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 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, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.
摘要：
根据AAMI/ESH/ISO通用标准（ISO81060-2：2018+Amd.1：2020），评估成人DBP-1333b上臂血压（BP）测量装置的准确性。在成年人群中招募受试者。测试装置是臂式电子血压计(DBP-1333b),参考装置是台式血压计(XJ11D)。以台式血压计测得的BP数据作为参考BP,对测试设备的非侵入性BP模块的准确性进行评估，以确定其是否符合要求。分析了来自90个人的数据。根据标准1,测试装置和参考装置之间的SBP的平均差为0.19mmHg,SD为7.45mmHg。DBP的平均差为-0.59mmHg,SD为6.47mmHg。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，SBP的SD为5.79mmHg，小于6.95mmHg，符合要求。DBP的SD为5.58mmHg，小于6.93mmHg，符合要求。结论是DBP-1333b符合AAMI/ESH/ISO通用标准（ISO81060-2：2018+Amd.1：2020），可以推荐成人使用。
