Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-02-01 Epub Date: 2023-09-14 DOI:10.1097/MBP.0000000000000678

Lei Shi, Xin-Yi Zhang, Jia-Yi Sun, Jin-Feng Chen, Yi-Fei Ma, Kai-Yuan Zhou

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引用次数: 0

Abstract

Objective: To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).

Methods: Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results.

Results: A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively.

Conclusion: The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.

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根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+AMD1:2020），验证 iHealth Track 上臂式血压计 KN-550BT 在普通人群中的应用。

目标：根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+AM根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+AMD1:2020），在普通人群中验证 iHealth Track KN-550BT 示波式上臂血压计：招募参与者，根据 ISO 81060-2:2018+AMD1:2020 使用相同的左臂顺序法测量血压。按照规程评估验证结果，并使用布兰德-阿尔特曼散点图显示测试设备与参考结果之间的差异：结果：共有 89 名合格参与者被纳入最终分析。在验证标准 1 中，收缩压和舒张压的测试设备和参考读数之间差异的平均值（± SD）分别为 -1.22 ± 5.76 mmHg 和 -0.08 ± 4.40 mmHg。对于标准 2，每位参与者的收缩压和舒张压测试设备和参考读数之间差异的平均值（± SD）分别为-1.22 ± 5.06 mmHg 和 -0.08 ± 3.84 mmHg：iHealth Track KN-550BT 上臂式血压计通过了 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+AMD1:2020）的所有要求，可推荐用于临床和普通人群的自我测量。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

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.