Jialiang Ma, Yao Xiao, Yage Wang, Jieqiong Zhang, Yi Wan
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引用次数: 0
摘要
目的：本研究旨在根据国际标准化组织（ISO） 81060- 2:20 18，评估用于自我/家庭血压测量的Wellvii BP Go自动振荡手指血压（BP）监测仪的准确性。方法：共纳入85名符合年龄、性别、血压分布标准的普通人群。采用相同的手臂/手指顺序测量方法与标准水银血压计进行比较，评估符合ISO 81060- 2:20 18方案。结果：共获得255对对照对进行分析。对于验证标准1，测试装置与参考收缩压/舒张压读数之间差异的平均值±SD为2.12±7.33和1.30±6.35 mmHg。对于验证标准2，每位参与者的测试装置和参考血压之间的平均收缩压/舒张压差的SD分别为6.58/5.60 mmHg。结论：Wellvii BP Go自动手指血压监测仪已通过ISO 81060- 2:20 18的要求，可推荐用于普通人群的自我/家庭血压测量。
Clinical evaluation of the Wellvii BP Go blood pressure monitor according to the International Standardization Organization 81060-2:2018.
Objective: This study aimed to evaluate the accuracy of the Wellvii BP Go automated oscillometric finger blood pressure (BP) monitor for self/home BP measurement according to the International Standardization Organization (ISO) 81060-2 : 2018.
Methods: A total of 85 eligible participants was included in the study to fulfill the age, sex, and BP distribution criteria of the ISO standard in the general population. The same arm/finger sequential measurement method was used for comparison with a standard mercury sphygmomanometer, and the assessment were in accordance with the ISO 81060-2 : 2018 protocol.
Results: A total of 255 comparison pairs were obtained for analysis. For validation Criterion 1, the mean ± SD of the differences between the test device and reference systolic BP/diastolic BP readings was 2.12 ± 7.33 and 1.30 ± 6.35 mmHg. For validation Criterion 2, the SD of the averaged systolic BP/diastolic BP differences between the test device and reference BP per participant was 6.58/5.60 mmHg, respectively.
Conclusion: The Wellvii BP Go automated finger BP monitor has passed the requirements of the ISO 81060-2 : 2018, and can be recommended for self/home BP measurement in general population.
期刊介绍：
Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research.
This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine.
Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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