Validation of the Arm-Type Fully Automatic Blood Pressure Monitor DBP-62F4B-P in adolescents and adults according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (ISO 81060-2:2018+Amd 2:2024) standard.
Aug 2026· Blood Pressure Monitoring· 0 citations· 14 references
Medicine
TL;DR
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.
Abstract
Objective
To validate the accuracy and safety of the Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) manufactured by JOYTECH Healthcare Co., Ltd. for blood pressure (BP) measurement in adolescents and adults with arm circumference 22.0-42.0 cm, in accordance with the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) (ISO 81060-2:2018+Amd 2:2024) international standard.
Methods
A total of 90 subjects were enrolled. Three valid datasets were collected from each subject, yielding 270 datasets for analysis. The mercury sphygmomanometer (reference device) data were used as the gold standard to evaluate whether the accuracy of the test device met the requirements.
Results
Based on 270 valid datasets, the mean difference between the test device and the reference device for SBP was -0.49 mmHg (SD = 7.29 mmHg), and for DBP was 1.45 mmHg (SD = 6.14 mmHg), meeting Criterion 1 requirements. Analysis based on individual averages of the 90 subjects showed a mean difference of -0.49 mmHg (SD = 5.57 mmHg) for SBP and 1.45 mmHg (SD = 5.05 mmHg) for DBP, both meeting the requirements of Criterion 2. The device maintained stable measurement performance across different arm circumferences, ages, and BP levels.
Conclusion
The Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) meets the accuracy and consistency requirements of the AAMI/ESH/ISO (ISO 81060-2:2018+Amd 2:2024) standard for SBP and DBP measurement in adolescents and adults with arm circumference 22.0-42.0 cm. It can be safely and effectively used for BP monitoring in clinical settings and, by extension, is suitable for home use based on its design features and validation performance.
OBJECTIVE
Validation of blood pressure (BP) devices is essential for reliable BP detection in pregnant populations. This study, therefore, set out to assess the measurement performance of the iHealth Track KN-550BT oscillometric upper-arm automated BP monitor for pregnant patients with the standard International Organization for Standardization (ISO) 81060-2:2018+AMD1:2020/AMD2:2024.
METHODS
This validation study enrolled a total of 45 pregnant patients. All BP measurements were performed sequentially on the left arm using the ISO unified standardized protocol. Device-reference discrepancies between the tested automated sphygmomanometer and the mercury sphygmomanometer were calculated and evaluated in strict accordance with the ISO standard specifications.
RESULTS
The study cohort consisted of 15 normotensive pregnant patients, 15 patients with gestational hypertension, and 15 patients diagnosed with preeclampsia. For the ISO Validation Criterion 1, the mean differences between the test device and mercury standard were -0.90 ± 4.82 mmHg for SBP and -0.91 ± 4.14 mmHg for DBP, respectively. For Criterion 2, the standard deviations of the averaged per-participant differences between device and reference measurements were 3.95 mmHg for SBP and 3.10 mmHg for DBP, respectively.
CONCLUSION
The iHealth Track KN-550BT upper-arm oscillometric 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
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.
Objective This study aimed to conduct a training-phase evaluation of a novel continuous automated non-invasive sphygmomanometer, oCare™ BP100, in intensive care unit (ICU) Taiwanese patients according to ISO 81060-3:2022 in Type T mode. The evaluation included stability testing and blood pressure change tracking. Methods A total of forty ICU patients were recruited from the National Taiwan University Hospital Hsin-Chu Branch. All enrolled patients had undergone unilateral radial artery catheterization in the forearm as part of routine clinical care. The catheter was connected to Philips patient monitors (Models: IntelliVue MX800 and X2) to obtain invasive blood pressure measurements for calibration purposes. Each subject underwent simultaneous monitoring with oCare™ BP100 sensors placed on the fingers of both hands. Paired measurements of the same side were further processed and followed ISO 81060-3:2022, for the defined Type T blood pressure monitor, the well-established stability method and the blood pressure change method were implemented and analyzed. Results The present study belongs to the training phase and therefore the study was not carried out completely according to the ISO 81060-3:2022 protocol, e.g., the distribution of gender and the eligible subject in BP change test not fulfilled. For all 6 analysis periods, for the corrected standard deviations of SBP, DBP, and MAP parameter defined ISO target thresholds (A) scorr ≤ 6 mmHg for each analysis period. In the Blood Pressure Change Test, at most 22 subjects the minimum requirement of 50 change points per subject, the for the change requirements were (B1) E¯50th≤25% and (B2) E¯85th≤50% error for blood pressure. Conclusion The present study demonstrated that a training-phase evaluation of Type T mode continuous automated non-invasive sphygmomanometer repeated SBP, DBP, and MAP measurement of oCare™ BP100 in Type T mode are stable across various analysis periods and patients. oCare™ BP100 in Type T Mode can track blood pressure changes in ICU patients during different activities. Even with the absence of females in the sex ratio and an insufficient number of participants in the blood pressure change test, the exploratory study still showed training-phase results that were within ISO target thresholds, full ISO validation remains to be completed.
Chao-Lun Lai, Yeh-Wen Lee, Chia-Fang Chang et al.· Frontiers in Medical Technol...· 0 citations
The metabolic syndrome (MetS) is characterized by having three or more of these risk factors: increased blood glucose (Glc), serum triglycerides (TG), blood pressure (BP), waist circumference (WC), and reduced high-density lipoprotein (HDL). Mobile diagnostics using point-of-care (POC) blood analyzers could help identify individuals at risk. This pilot study assessed reliability and validity of MetS risk factor analysis using POC analyzers in a mobile examination unit. Fifty participants (52 ± 7y; 170 ± 10 cm; 80 ± 19 kg, m/f: 21/29) were included for analysis. The mobile examination unit was equipped with different POC analyzers (Alere, LABGEO, CardioChek for Glc, HDL, TG; Quo-Test-A1C Testkit for HbA1c‘). Agreement compared to a reference laboratory (RefLab) was analyzed by Bland-Altman (bias, Limits of Agreement (LoA)), ICC, SEM and McNemar’s test. Test-retest analysis was assessed on two different days (max. two weeks apart) using Spearman’s rho, ICC, test-retest variability (TRV%) and McNemar’s test. Based on the smallest bias and low number of missing values (Glc: -5 [LoA − 25 to 6] mg/dl; TG: 8 [LoA − 58 to 30] mg/dl; HDL: -2 [LoA − 14 to 9] mg/dl), and the highest agreement in MetS diagnosis compared to the results of RefLab, the Alere POC device was chosen. Test-retest reliability (n = 16) for MetS risk factors and HbA1c measured in the mobile setup ranged from poor to excellent with low TRV (0.9–5.8%). Risk factor classification and MetS diagnosis did not differ between measurement days. A mobile setup using the Alere POC analyzer could be used as a valid mobile screening method for MetS to ensure early detection of risk factors.
S. Houtenbos, A. Schraplau, P. Wippert et al.· BMC Primary Care· 0 citations
Background Out-of-office blood pressure (BP) monitoring is essential for diagnosing and controlling hypertension. Between 2015 and 2025, wearable devices and portable cuffless platforms emerged that estimate BP without a conventional brachial cuff; their evaluation is complicated by technological heterogeneity, calibration, sensitivity to dynamic conditions, and recent device-specific standards. Objective To map the evidence published between 2015 and 2025 on wearable and portable cuffless devices for BP measurement or estimation, describing form factors, technologies, calibration/recalibration, validation, populations, settings, and standards or regulatory frameworks. Methods A scoping review was conducted in accordance with PRISMA-ScR and the Joanna Briggs Institute, using the PCC framework. Sources were searched in PubMed/MEDLINE, Scopus, Web of Science, and Embase, supplemented by device-directed searches and citation chasing. Extraction captured population, device, technology, setting, calibration, standard/protocol, comparator, metrics, limitations, conflicts, and funding. Results Sixty-three sources were included: 7 standards/consensus/regulatory documents, 1 case study, 6 reviews, and 49 primary studies. Primary evidence covered watches with miniaturized cuffs, wearable or portable cuffless devices, and rings/finger devices. Oscillometric wrist watches were methodologically closer to conventional automated monitors, although limited by positioning requirements, reading errors, and scarce ambulatory evidence. Cuffless devices relied on PPG/PWA, PTT/PAT, tonometry, or multimodal approaches, with calibration/recalibration and proprietary algorithms. Critical gaps persisted in post-calibration stability, dynamic conditions, sleep, treatment, arrhythmias, and special populations. Conclusions The 2015–2025 ecosystem shows rapid progress and a transition toward cuffless-specific validation. However, clinical utility depends on intended use, population, calibration/recalibration, and setting. Performance should not be extrapolated across technologies, populations, or contexts.
J. C. Bustamante-Rodríguez, Jhosmer Ballena-Caicedo, Julio César Bautista-Zuta et al.· Frontiers in Digital Health· 0 citations
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.
A. de Greeff, Catherine A Cluver, A. Shennan· Blood Pressure Monitoring· 0 citations