Chen Wan, Xiang Yuhan, Cheng Rui, Zhang Yang
Departments of Cardiology.
General Practice, Chongqing Jiulongpo People's Hospital, Chongqing.
Blood Press Monit. 2025 Jun 1;30(3):113-116. doi: 10.1097/MBP.0000000000000744.
The study aimed to validate the Pangao PG-800B18 oscillometric upper-arm blood pressure monitor in the general population in accordance with the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd) 1:2020 protocol.
Participants were recruited, and the same left-arm sequential method was used for blood pressure measurement in accordance with the protocol. Data validation and analysis were performed according to the protocol, and the Bland-Altman scatter plot was used to show the difference between the test device and reference results.
A total of 86 participants were included in the validation analysis. For the validation criterion 1 of the protocol, the mean ± SD of the differences between the test device and reference readings was -1.21 ± 6.71 mmHg and -0.73 ± 5.83 mmHg for systolic (SBP) and diastolic blood pressure (DBP), respectively. Furthermore, the SD of the differences between the test device and reference readings per participant was 5.81 and 5.02 mmHg for SBP and DBP, fulfilling the criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP.
The Pangao PG-800B18 upper-arm blood pressure monitor fulfilled the requirements of the ISO validation standard and can be recommended for clinical use and self-measurement in the general population.
本研究旨在根据国际标准化组织（ISO）81060-2:2018及修订版（修订案1:2020）协议，在普通人群中验证攀高PG-800B18振荡式上臂血压计。
招募参与者，并按照协议使用相同的左臂序贯法测量血压。根据协议进行数据验证和分析，采用Bland-Altman散点图展示测试设备与参考结果之间的差异。
共有86名参与者纳入验证分析。对于协议的验证标准1，测试设备与参考读数之间收缩压（SBP）和舒张压（DBP）差异的均值±标准差分别为-1.21±6.71 mmHg和-0.73±5.83 mmHg。此外，每位参与者测试设备与参考读数之间差异的标准差，SBP为5.81 mmHg，DBP为5.02 mmHg，满足标准2，即SBP标准差≤6.95，DBP标准差≤5.89。
攀高PG-800B18上臂血压计符合ISO验证标准要求，可推荐用于普通人群的临床使用和自我测量。
