Department of Health Services, Fourth Military Medical University.
Department of Geriatrics, Xijing Hospital, Fourth Military Medical University.
Blood Press Monit. 2024 Apr 1;29(2):93-98. doi: 10.1097/MBP.0000000000000683. Epub 2023 Nov 15.
To evaluate the accuracy of the Wellvii VitalDetect automated oscillometric finger blood pressure monitor (single cuff size) for self/home blood pressure measurement according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).
According to the universal standard, a total of 92 participants were recruited and finally blood pressure of 85 eligible participants was sequentially measured and compared with a standard mercury sphygmomanometer.
A total of 255 comparison pairs were obtained and analyzed based on the universal standard. For the validation criterion 1 of the ISO 81060-2:2018 universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.66 ± 7.67 and 1.04 ± 6.45 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was ± 6.49 mmHg (pass ≤ 6.73 mmHg) and ± 5.67 mmHg (pass ≤ 6.86 mmHg) for systolic and diastolic blood pressure, respectively.
The Wellvii VitalDetect automated finger blood pressure monitor passed all the requirements for validation by the ISO 81060-2:2018 universal standard and can be recommended for self/home blood pressure measurement in general population.
根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018）评估 Wellvii VitalDetect 自动示波法指套式血压计（单袖带尺寸）用于自我/家庭血压测量的准确性。
根据通用标准，共招募了 92 名参与者，最终对 85 名符合条件的参与者的血压进行了顺序测量，并与标准汞柱血压计进行了比较。
根据 ISO 81060-2:2018 通用标准，共获得并分析了 255 对比较。对于 ISO 81060-2:2018 通用标准的验证标准 1，测试设备和参考血压读数之间差异的平均值±SD 分别为收缩压和舒张压的 1.66±7.67mmHg 和 1.04±6.45mmHg。对于标准 2，测试设备和参考血压每个受试者之间平均血压差异的 SD 分别为±6.49mmHg（合格值≤6.73mmHg）和±5.67mmHg（合格值≤6.86mmHg）（收缩压和舒张压）。
Wellvii VitalDetect 自动指套式血压计通过了 ISO 81060-2:2018 通用标准的所有验证要求，可推荐用于一般人群的自我/家庭血压测量。
