Validation of the Wellvii VitalDetect blood pressure monitor in general population according to the International Standardization Organization 81060-2:2018.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2024-04-01 Epub Date: 2023-11-15 DOI:10.1097/MBP.0000000000000683

Lin-Yi Li, Jin-Feng Chen, Sen Bing, Kui Liu, Rui Cheng, Yi Wan

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引用次数: 0

Abstract

Objective: 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).

Methods: 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.

Results: 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.

Conclusion: 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.

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根据国际标准化组织81060-2:2018，在普通人群中验证Wellvii VitalDetect血压监测仪。

目的:根据AAMI/ESH/ISO通用标准(ISO 81060-2:2018)，评估Wellvii VitalDetect自动振荡式手指血压计(单袖带尺寸)用于自我/家庭血压测量的准确性。方法:按照通用标准，共招募92名受试者，最终对85名符合条件的受试者进行血压测量，并与标准汞柱血压计进行比较。结果:共获得255对对照，并按通用标准进行分析。对于ISO 81060-2:2018通用标准验证准则1，测试装置与参考血压读数差异的平均值±SD分别为收缩压和舒张压1.66±7.67和1.04±6.45 mmHg。对于标准2，每位受试者的收缩压和舒张压的平均血压差与参考血压差的标准差分别为±6.49 mmHg(通过≤6.73 mmHg)和±5.67 mmHg(通过≤6.86 mmHg)。结论:Wellvii VitalDetect自动手指血压监测仪通过了ISO 81060-2:2018通用标准验证的所有要求，可推荐用于普通人群的自我/家庭血压测量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.