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.
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.
The iHealth Track KN-550BT upper-arm oscillometric upper-arm automated BP monitor fully complies with the requirements of ISO 81060-2:2018+AMD1:2020/AMD2:2024, and can be recommended for clinical application and home self-BP measurement among pregnant patients.
Ying Zhang, Dongmei Wang, Chunmei Cui et al.· Blood Pressure Monitoring· 0 citations
The Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) meets the accuracy and consistency requirements of the AAMI/ESH/ISO standard for SBP and DBP measurement in adolescents and adults with arm circumference 22.0-42.0 cm and is suitable for home use based on its design features and validation performance.
Ambulatory blood pressure monitoring (ABPM) is recommended for confirming hypertension and assessing out-of-office blood pressure (BP). However, patient burden and device tolerability may limit broader implementation. We compared participant experience with a traditional oscillometric ABPM device and a compact cuff-integrated ABPM. The PRO-BP Study was a pilot randomized crossover study of 20 adults in New York City. Participants completed two 24-hour ABPM periods over 7 days using the SpaceLabs 90227 and SOMNOmedics ABPM Pro devices. After each period, participants rated comfort, pain, sleep interference, embarrassment, noise, skin irritation, and interference with daytime activities. Both devices achieved guideline-based recording-quality thresholds. Compared with SpaceLabs, ABPM Pro was associated with greater comfort (median 7.0 [IQR, 5.0-8.5] vs 3.5 [IQR, 2.0-6.5]; P=0.004), less pain (1.5 [0-3.5] vs 5.0 [0.5-7.0]; P=0.003), and less embarrassment (0.5 [0-3.5] vs 3.0 [0-6.0]; P=0.01). Other experience ratings did not differ significantly. Participant experience should be considered alongside recording quality when evaluating validated ambulatory BP monitoring technologies.
J. Soddano, B. Fernandez-Sedano, S. Shurovi et al.· medRxiv· 0 citations
This represents the first evaluation of a Device Type 3 cuffless blood pressure algorithm (automated, wearable, demographic-calibrated, not at heart level) meeting ESH awake/asleep test criteria, suggesting Alysis-001's potential as a clinically viable alternative for ambulatory blood pressure monitoring in hypertensive patients.
ABSTRACT Objective The aim of this study was to evaluate the accuracy and agreement of heart rate (HR) and peripheral oxygen saturation (SpO2) measurements obtained using the wearable Owlet Smart Sock (OSS) in anaesthetised cats, compared with a reference veterinary bedside monitor (Monitor 1). Methods Twenty healthy cats aged 1–2 years and weighing 3.2 and 5.1 kg were enrolled. All animals underwent a standardised general anaesthesia protocol. HR and SpO2 were recorded simultaneously using the OSS and Monitor 1 at 1‐minute intervals for 20 min. A total of 307 paired measurements were analysed. Agreement was assessed using Bland–Altman analysis and clinical equivalence was evaluated using the two one‐sided tests (TOST) procedure, with predefined equivalence margins of ±10 bpm for HR and ±3% for SpO2. Results A very strong correlation was observed between OSS and Monitor 1 for HR measurements (r = 0.995; p < 0.0001). The mean difference was 0.18 bpm (95% CI: −0.38–0.40), demonstrating clinical equivalence (p < 0.0001). For SpO2 measurements, a statistically significant linear correlation was identified (r = 0.634; p < 0.0001). The mean difference was ‐0.5% (95% CI: −0.74 to −0.29), remaining within the predefined ±3% equivalence margin and indicating clinical equivalence (p < 0.0001). Conclusion In healthy cats, the OSS demonstrated high agreement with the reference monitor for HR measurements and provided clinically acceptable SpO2 values within established equivalence limits. Further validation under diverse clinical conditions and in different patient populations is warranted.
Şule Melek, Ö. Orhun, M. Senocak et al.· Veterinary Medicine and Scie...· 0 citations
Objectives
Accurate blood pressure (BP) measurement is essential for reliably estimating hypertension prevalence in population-based surveys. However, evidence supporting the use of oscillometric BP devices in pediatric populations remains limited. This study compared BP measurements obtained using an oscillometric device (OD) and an auscultatory device (AD) and evaluated inter-device agreement and the impact of device choice on hypertension prevalence estimates.
Methods
BP was measured sequentially with the AD and OD in 251 children and adolescents participating in the Korea National Health and Nutrition Examination Survey. Inter-device agreement was assessed using mean differences, limits of agreement, concordance correlation coefficients (CCCs), and regression analyses. Differences in prevalence estimates for elevated BP (EBP) and hypertension were also examined.
Results
Mean inter-device differences were minimal for systolic BP (SBP) (0.2 ± 5.9 mmHg) but negative for diastolic BP (DBP) (-1.5 ± 6.1 mmHg), with larger discrepancies in older girls. Agreement was moderate to good for SBP (CCC = 0.79) and weaker for DBP (CCC = 0.60). Nevertheless, more than 85% of paired measurements were within ±10 mmHg. Prevalence estimates for EBP (11.6% vs. 10.0%) and hypertension (4.8% vs. 4.4%) were comparable between devices, with relatively high negative agreement and overall agreement.
Conclusion
Despite modest underestimation of DBP in specific subgroups, oscillometric BP measurement showed acceptable agreement with the auscultatory method and yielded similar hypertension prevalence estimates. These findings suggest that oscillometric devices may be useful for pediatric BP measurement in public health surveillance systems.
Sung Hye Kim, Yu-Mi Kim, Hack-Lyoung Kim et al.· Epidemiology and Health· 0 citations
