Validation of the Microlife WatchBP O3 (BP3SZ1-1) upper-arm, oscillometric blood pressure device in pregnancy according to ISO 81060-2:2018.

IF 1 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE
Annemarie de Greeff, Catherine A Cluver, Andrew H Shennan
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Abstract

To assess the accuracy of the Microlife WatchBP O3 upper-arm, oscillometric blood pressure (BP) device, suitable for clinic, home, and ambulatory use, in a pregnant population. This device was assessed according to the ISO 81060-2:2018 protocol in 45 pregnant women, including women with gestational hypertension and pre-eclampsia. Two cuff sizes were available for arm circumferences of 22-32 and 32-42 cm. Nine sequential same-arm measurements were obtained from each participant, alternating between the test device and auscultation. Forty-nine women were included, and four were excluded. Data from 45 women, including 14 women with gestational hypertension and 15 women with pre-eclampsia, were analyzed according to the protocol. The mean difference with SDs were 0.6 ± 7.9 mmHg for SBP and 3.4 ± 6.0 mmHg for DBP. The Microlife WatchBP O3 upper-arm, oscillometric BP device passed the criteria of the ISO 81060-2:2018 standard in normotensive pregnant women, women with gestational hypertension, and women with pre-eclampsia.

Microlife WatchBP O3 (BP3SZ1-1)上臂振荡式妊娠血压仪根据ISO 81060-2:2018进行验证。
评估Microlife WatchBP O3上臂振荡血压(BP)装置的准确性,适用于临床、家庭和门诊孕妇人群。根据ISO 81060-2:2018方案对45名孕妇进行了该设备的评估,其中包括患有妊娠高血压和先兆子痫的妇女。手臂围22-32和32-42厘米有两种袖口尺寸可供选择。从每个参与者获得9个连续的同臂测量,在测试装置和听诊之间交替进行。49名女性被纳入研究,4名被排除在外。根据该方案分析了45名妇女的数据,其中包括14名妊娠期高血压妇女和15名先兆子痫妇女。SDs的平均差值为收缩压0.6±7.9 mmHg,舒张压3.4±6.0 mmHg。Microlife WatchBP O3上臂振荡血压仪通过了ISO 81060-2:2018标准,适用于血压正常的孕妇、妊娠期高血压患者和先兆子痫患者。
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来源期刊
Blood Pressure Monitoring
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.
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