Li Duan, Li Yiming, Li Jiaheng, Gu Yuan, Shang Fujun
Department of Health Service, Fourth Military Medical University.
Department of General Practitioner, School of Basic Medicine, Fourth Military Medical University.
Blood Press Monit. 2025 Apr 1;30(2):93-96. doi: 10.1097/MBP.0000000000000740. Epub 2024 Dec 24.
This study aimed to evaluate the accuracy of the ANDON KD-7920 oscillometric wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020.
The same arm sequential method was used for blood pressure measurement among qualified participants according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the criteria of the protocol, and the Bland-Altman scatter plot was used to present the difference between the test device and reference results.
A total of 90 participants were included in the study. According to criterion 1 of the validation protocol, the mean ± SD of the differences between the test device and reference readings was 0.76 ± 6.23 mmHg and -0.13 ± 5.57 mmHg for systolic and diastolic blood pressure, respectively, which met the requirements of less than 5 ± 8 mmHg. According to the criterion 2, the average differences between the test device and reference readings per participant were 0.76 ± 5.56 mmHg and -0.13 ± 5.27 mmHg for systolic and diastolic blood pressure, respectively, which also met the requirements.
The ANDON KD-7920 wrist blood pressure monitor passed all the requirements of the ISO 81060-2:2018+AMD1:2020 and can be recommended for clinical use and self-measurement in general population.
本研究旨在根据ISO 81060-2:2018+AMD1:2020评估ANDON KD-7920示波腕式血压计在普通人群中的准确性。
根据ISO 81060-2:2018+AMD1:2020，对合格参与者采用同一手臂连续测量法测量血压。按照方案标准评估验证结果，并使用Bland-Altman散点图展示测试设备与参考结果之间的差异。
本研究共纳入90名参与者。根据验证方案的标准1，测试设备与参考读数之间收缩压和舒张压差异的均值±标准差分别为0.76±6.23 mmHg和-0.13±5.57 mmHg，满足小于5±8 mmHg的要求。根据标准2，每位参与者测试设备与参考读数之间收缩压和舒张压的平均差异分别为0.76±5.56 mmHg和-0.13±5.27 mmHg，也满足要求。
ANDON KD-7920腕式血压计通过了ISO 81060-2:2018+AMD1:2020的所有要求，可推荐用于普通人群的临床使用和自我测量。
