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.
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.
BACKGROUND:Nocturnal blood pressure patterns reflect autonomic and volume-related stress and may affect outcomes after pulmonary vein isolation (PVI). We examined their association with atrial fibrillation recurrence after PVI using ambulatory blood pressure monitoring (ABPM). METHODS AND RESULTS:We retrospectively studied 74 consecutive patients with preprocedural ABPM. Patients were classified as dipper (≥10% nocturnal systolic blood pressure decline), nondipper (0 to <10%), or riser (nighttime > daytime blood pressure). Recurrence was defined as any documented atrial tachyarrhythmia lasting greater than or equal to 30 s after the 90-day blanking period; episodes beginning during blanking and persisting beyond day 90 were assigned to day 90. Recurrence occurred in 27 patients (36.5%). Pattern distribution differed significantly by recurrence status (P = 0.002), with recurrence rates of 26.1% in dippers, 31.0% in nondippers, and 88.9% in risers. Kaplan-Meier analysis showed significantly lower freedom from recurrence in risers (log-rank P < 0.001). In univariable Cox analysis using dippers as the reference, risers were associated with recurrence (hazard ratio: 9.50, 95% confidence interval: 3.22-27.97; P < 0.001), whereas nondippers were not. In an exploratory multivariable model including nocturnal blood pressure pattern, persistent atrial fibrillation, and age, the riser pattern remained associated with recurrence (hazard ratio: 9.53, 95% confidence interval: 3.00-30.29; P < 0.001). CONCLUSION:The riser pattern on ABPM was associated with early postblanking recurrence after PVI and may provide complementary information for risk stratification.
The aim of the study was to determine the accuracy of the Hingmed V03D oscillometric monitor for upper arm blood pressure (BP) measurement according to the new International Organization for Standardization (ISO) 81060-2:2018/Amd1:2020/Amd2:2024 protocol. The Hingmed V03D is provided with a wide-range cuff for arm circumferences ranging from 22 to 41 cm. The device was tested in 85 subjects from the general population. The mean age of the participants was 51.7 years (range: 17-71 years). The mean device-observer difference was -1.2 ± 4.0 mmHg for SBP and -2.0 ± 3.7 mmHg for DBP, in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Criterion 2 of the ISO 81060-2:2018/Amd1:2020/Amd2:2024 protocol was also satisfied. The SD of SBP and DBP were 2.6 and 2.9 mmHg, respectively, well below the maximum values required by the protocol (6.84 and 6.65 mmHg for SBP and DBP, respectively). The measurement errors were unrelated to arm size. These results indicate that the Hingmed V03D is a reliable BP monitor because it satisfied the requirements of the ISO 81060-2:2018/Amd1:2020/Amd2:2024 protocol for the general population. This device showed that a single wide-range cuff can provide accurate measurements in standard as well as large arms with circumferences ranging from 22 to 41 cm.
BACKGROUND:Overt policing is a stressful occupational duty that burdens the cardiovascular system. Individuals with high blood pressure (BP) have been shown to have exacerbated cardiovascular reactivity to mental stress tests. However, it is unknown whether this premise is the same for policemen. AIM:To assess whether police officers with higher baseline BP exhibit exacerbated cardiovascular reactivity to mental stress. METHOD:Forty-one policemen (34 ± 4 years) were divided into two groups: lower BP (SBP < 120 mmHg, n = 15) and higher BP (SBP ≥ 120 mmHg, n = 26). The policemen were also subjected to acute mental stress. Cardiovascular reactivity was assessed at 2- and 4-min, while cardiovascular recovery was analyzed at 3 and 5 min. RESULTS:Policemen with higher baseline BP showed higher SBP values ( P < 0.001) at 2 min (148 ± 12 vs. 128 ± 13 mmHg) and 4 min (140 ± 10 vs. 125 ± 9 mmHg) of the acute mental stress, compared with policemen with lower baseline BP. During recovery, policemen with higher BP showed higher SBP values ( P < 0.001) at 3 min (130 ± 10 vs. 120 ± 7 mmHg) and 5 min (129 ± 8 vs. 116 ± 8 mmHg) compared with policemen with lower BP. DPB was higher ( P = 0.005) in policemen with higher BP compared with the policemen with lower BP, regardless of time. There was no difference in heart rate response between groups ( P > 0.005). CONCLUSION:Policemen with a higher baseline BP exhibited greater cardiovascular responses during acute mental stress.
BACKGROUND:Hypertensive disorders of pregnancy remain a leading cause of maternal and fetal morbidity and mortality worldwide. In women with chronic hypertension, adequate 24-h ambulatory blood pressure (ABPM) control has been associated with a reduced risk of adverse outcomes, including preeclampsia. However, the ability of office blood pressure (BP) measurements to reliably identify women with controlled ABPM during pregnancy remains uncertain. We conducted a retrospective cohort study including pregnant women with chronic hypertension evaluated before 20 weeks of gestation at a high-risk pregnancy center. METHODS:Office BP and 24-h ABPM were assessed using a standardized protocol at three gestational periods (14, 20, and 30 weeks). Controlled ABPM was defined by 24-h, daytime, and nighttime BP thresholds. Receiver operating characteristic curve analyses were performed to evaluate the discriminative ability of office systolic and diastolic BP to identify controlled ABPM and to explore potential cut-off values. RESULTS:Among 247 women with chronic hypertension, office BP demonstrated limited discriminatory performance across all gestational stages. Area under the curve values were consistently close to or below 0.5 for both systolic and diastolic BP, indicating poor classification ability. Cutoff values identified using the Youden index were clinically implausible and would have classified only a minimal proportion of women as having controlled ABPM. Even when clinically intuitive office BP thresholds were applied, sensitivity and specificity remained low. These findings indicate that office BP measurements cannot be considered a reliable surrogate for ABPM control in pregnant women with chronic hypertension. CONCLUSION:Consequently, ABPM remains essential for accurate BP assessment and risk stratification, particularly during the second half of pregnancy.
OBJECTIVE:To evaluate the accuracy of a novel wrist-worn cuff-calibrated photoplethysmography (PPG)-based remote patient monitoring device as an alternative to ambulatory blood pressure monitoring (ABPM). METHODS:This prospective single-center study included 40 adult patients undergoing standard 24 h ABPM with a 30-min measurement interval. Participants were equipped with a wrist-worn PPG device (CardioWatch 287-2; Corsano Health B.V., The Hague, The Netherlands, manufactured by MMT, Geneva, Switzerland) throughout the ABPM period. Investigational and reference measurements were compared using the average difference and SD for the full 24-h period as well as for awake and asleep periods, individually. Differences in awake-asleep blood pressure (BP) change between the investigational and reference devices were evaluated for all patients and per night-time BP dipper category. Finally, investigational BP monitoring accuracy under motion was visualized. RESULTS:Throughout the 24-h period, the absolute difference in average SBP and DBP was 3.65 (SD ± 4.57) and 2.98 (SD ± 3.91), respectively. Similar results were obtained for the subsets of day- and night-time determinations. The absolute difference in average awake-asleep BP change was 2.36 (SD ± 2.40) for SBP and 2.17 (SD ± 2.13) for DBP. Comparable absolute differences were present within each of the night-time dipper categories. The performance of the investigational device remained stable under motion. CONCLUSION:This study presents initial evidence supporting the accuracy of the evaluated wrist-worn PPG-based device in measuring 24-h as well as day- and night-time BP. In all cases, the average difference and SD remained below the cutoff values described by recent European Society of Hypertension guidelines. Therefore, the presented method can provide an accurate alternative to ABPM.
OBJECTIVES:To investigate the association between long-term predialysis blood pressure (BP) change and all-cause mortality in patients on maintenance hemodialysis (MHD). METHODS:We retrospectively included patients receiving MHD from 1 January 2019 to 31 December 2024. The regression slope was used to estimate BP temporal change with dialysis vintage. The regression slope was divided into three groups: small slope (absolute number < 0.05), large increasing slope (≥ 0.05 group), and large decreasing slope (≤-0.05 group). If the regression slope was positive, we defined the trend of BP was increasing. Conversely, BP showed a decreasing trend. Survival analysis was performed using Cox proportional hazards regression models. RESULTS:A total of 812 patients with 317 894 predialysis BP measurements were included in the final cohort. The mean predialysis BP was 146.44/85.66 mmHg. During the study period, 161 deaths occurred. In multivariable Cox regression analysis, patients with a small slope of SBP or DBP demonstrated the highest survival rate. Both patients with a large increasing slope or a large decreasing slope had significantly higher mortality ( P < 0.001). Notably, a BP change direction (an increasing or decreasing trend) was not associated with mortality. The association between long-term predialysis BP slope and mortality was independent of age at first hemodialysis, diabetic nephropathy, coronary heart disease, pulse rate, antihypertensive drug, and ultrafiltration. This association was consistent for both SBP and DBP. CONCLUSION:A stable trend of long-term predialysis BP was associated with a favorable survival outcome. Both SBP and DBP influence clinical outcomes.
Guidelines recommend initial blood pressure assessment on both arms, with the higher-reading arm used for future measurements. As simultaneous measurement devices are often unavailable, we evaluated if sequential measurements are appropriate for assessing interarm differences. Blood pressure was measured in Shanghai using an automated system. Consecutive readings were taken with 1-min intervals, beginning with the right followed by the left arm, with a third reading if the difference between the first two exceeded 5 mmHg. In 7838 participants, right arm readings were consistently higher, with mean interarm systolic/diastolic differences of 4.59/1.01 mmHg if two readings on each arm, 6.24/1.45 mmHg if two readings on one and three readings on another arm, and 7.22/1.90 mmHg if three readings on each arm. This sequential measurement approach led to more frequent right arm selection for blood pressure measurement and potential overestimation of the interarm differences. Simultaneous measurements may be needed, but future studies are required to confirm this.
BACKGROUND:Multimorbidity represents significant public health challenges, particularly in postmenopausal women, who experience increased risks for cardiovascular and metabolic diseases because of hormonal changes. While exercise therapy has shown promise in enhancing health outcomes for individuals with multimorbidity, evidence of its effectiveness in this specific population remains limited. OBJECTIVE:This study investigated the effects of a 12-week aerobic training program on ambulatory blood pressure, blood pressure variability, and arterial stiffness in postmenopausal women with and without cardiometabolic multimorbidity. METHODS:A controlled, quasi-experimental study was conducted with 41 women divided into two groups: SINGLE (one cardiometabolic condition; n = 18) and MULTI (multimorbidity; n = 23). Participants underwent aerobic training three times a week. Ambulatory blood pressure, blood pressure variability, and arterial stiffness were assessed before and after the intervention. RESULTS:A significant reduction in diastolic nocturnal dipping was observed only in the MULTI group (interaction P = 0.019), decreasing from 10 ± 12% to 7 ± 9%. Both groups showed a significant reduction in systolic (SINGLE: 21 to 8; MULTI: 19 to 7) and diastolic morning surge (SINGLE: 16 to 11; MULTI: 16 to 6) (time P < 0.001). No interaction effect was observed in arterial stiffness parameters. An exercise intervention effect ( P = 0.001) indicated an increase in augmentation index (%) in both groups following aerobic training. CONCLUSION:A 12-week aerobic program improved morning surge blood pressure in postmenopausal women. However, the MULTI group showed reduced nocturnal dipping.
Accurate blood pressure (BP) measurement is essential for hypertension management. Automated oscillometric BP monitors must be validated according to international standards before clinical and home use. This study aimed to evaluate the accuracy of the YuWell YE680B automated upper-arm BP monitor in accordance with the ISO 81060-2:2018 Universal Standard and its amendments, Amd.1:2020 and Amd.2:2024. A validation study was conducted using the same-arm sequential measurement method in a mixed population of adults and children aged greater than or equal to 3 years. Reference BP measurements were obtained by two trained observers using a calibrated mercury sphygmomanometer and a dual-head stethoscope. Device accuracy was assessed according to ISO criteria 1 and 2, and agreement was evaluated using Bland-Altman analysis. A total of 100 participants contributed to 300 valid paired measurements. The mean difference (test - reference) was -0.3 ± 6.77 mmHg for SBP and 0.4 ± 6.08 mmHg for DBP, fulfilling the requirements of ISO criterion 1. The SD of the participant-level mean differences was 5.81 mmHg for SBP and 5.32 mmHg for DBP, meeting the thresholds of ISO criterion 2. Bland-Altman analysis demonstrated good agreement across the measured BP range, with differences evenly distributed across the supported arm circumference range (17-52 cm). The YuWell YE680B automated upper-arm BP monitor met the accuracy requirements of ISO 81060-2:2018/Amd.1:2020/Amd.2:2024 in a mixed population of adults and children aged greater than or equal to 3 years. These findings support its use for BP measurement in clinical and home settings.
The aim of the study was to determine the accuracy of the Prolife PX7 Premium monitor for upper arm blood pressure (BP) measurement according to the International Organization for Standardization (ISO) 81060-2:2018/Amd1:2020/Amd2:2024 protocol. The Prolife PX7 Premium device, an oscillometric fully automatic BP monitor designed for BP measurement by both healthcare professionals and home users, is provided with a single wide-range conical cuff suitable for arm circumferences ranging from 22 to 45 cm. The device was tested in 86 subjects from the general population (52.3% men) with a mean age of 43.2 years. The mean device-observer systolic and diastolic BP differences and their SDs were in agreement with criterion 1 of the protocol requirements (≤5 ± 8 mmHg), being 4.3 ± 4.4 and 3.4 ± 4.3 mmHg, respectively. The measurement errors were unrelated to the arm sizes. Also, criterion 2 of the ISO 81060-2:2018/Amd1:2020/Amd2:2024 protocol was satisfied. The SDs of systolic and diastolic BPs were 4.2 and 4.1 mmHg, respectively, well below the maximum values required by the protocol (5.49 and 5.56 mmHg for systolic and diastolic BPs, respectively). The present results show that the Prolife PX7 Premium monitor satisfied the requirements of the ISO 81060-2:2018/Amd1:2020/Amd2:2024 protocol for the general population, demonstrating that a single cuff designed for a wide range of arm sizes can provide reliable measurements across a 22-45 cm range of arm circumferences.
OBJECTIVE:This study aimed to evaluate the accuracy of the Wellvii BP Go automated oscillometric finger blood pressure (BP) monitor for self/home BP measurement according to the International Standardization Organization (ISO) 81060-2 : 2018. METHODS:A total of 85 eligible participants was included in the study to fulfill the age, sex, and BP distribution criteria of the ISO standard in the general population. The same arm/finger sequential measurement method was used for comparison with a standard mercury sphygmomanometer, and the assessment were in accordance with the ISO 81060-2 : 2018 protocol. RESULTS:A total of 255 comparison pairs were obtained for analysis. For validation Criterion 1, the mean ± SD of the differences between the test device and reference systolic BP/diastolic BP readings was 2.12 ± 7.33 and 1.30 ± 6.35 mmHg. For validation Criterion 2, the SD of the averaged systolic BP/diastolic BP differences between the test device and reference BP per participant was 6.58/5.60 mmHg, respectively. CONCLUSION:The Wellvii BP Go automated finger BP monitor has passed the requirements of the ISO 81060-2 : 2018, and can be recommended for self/home BP measurement in general population.
Several protocols have been devised for the validation of blood pressure (BP) measurement monitors to establish minimum standards of accuracy. Three aspects are crucial for improving the agreement between the device and the reference BP which depend on the quality of the laboratory and the experience of the investigators: (a) the choice of the most appropriate cuff in relation to the subject's arm size. As shown by Marks and Groch the measurement error gradually and remarkably increases in a linear fashion when the optimal cuff width/arm circumference ratio is not achieved. This mandates that in expert laboratories numerous cuffs should be available with progressively increasing bladder width. (b) Minimizing patient's BP variability during testing is the most challenging goal to achieve for reducing the SD of the between-method BP differences. Habituation to the medical environment can be increased by prolonging the pretest interval to 15-30 min. (c) The laboratory must be of high standard both in terms of environmental conditions and available instrumentation. A perfect harmony and interrelationship of the team members in the various stages of the test must be achieved. This condition is acquired through a long period of formal education and supervised practice. Recently, several validation studies have achieved bias and precision far below the minimum required criteria probably due to a more careful and rigorous assessment of performance. This led some authors to suggest to move the threshold of the mean difference between device and reference BP from 5 down to 3 mmHg.
OBJECTIVE:This study aimed to assess the accuracy of the OMRON M2 Intelli IT+ (HEM-7146T2-EBK) brachial device for BP measurement in children and adults, according to the International Organization for Standardization (ISO) 81060-2:2018/AMD 2:2024 Standard. METHODS:OMRON M2 Intelli IT+ is an oscillometric device designed to measure BP at the brachial level. This study adhered to the ISO 81060-2:2018/AMD 2:2024 protocol and employed the same arm sequential BP measurement method. A total of 85 participants meeting the protocol-specified age, sex, BP, and cuff distribution criteria were included. The accuracy analysis utilized criterion 1 and criterion 2 defined in the ISO protocol. RESULTS:Eighty-seven individuals were selected; two were excluded because of high BP variability ( n = 1) and arrhythmia ( n = 1). Eighty-five participants (50 adults and 35 children) were included. Mean BP differences between the observer measurements were -0.1 ± 2.1/0.5 ± 1.9 mmHg [systolic BP (SBP)/diastolic BP (DBP)]. In the children and adult population ( n = 85), criterion 1, the mean BP differences between the reference measurements and the device were -2.1 ± 4.4/-0.3 ± 3.7 mmHg for SBP and DBP (≤5 ± 8 mmHg); criterion 2 was 3.1/2.9 mmHg for SBP and DBP (≤6.62/6.95 mmHg). In the children's population ( n = 35), criterion 1 values were -3.7 ± 4.0/-1.1 ± 4.1 mmHg for SBP and DBP (≤5 ± 8 mmHg). CONCLUSION:The OMRON M2 Intelli IT+ (HEM-7146T2-EBK) device meets the requirements of the ISO 81060-2:2018/AMD 2:2024 protocol, supporting its use in children and adults for home BP monitoring.
This study aims to evaluate the accuracy of the Hanvon KSY3600 Korotkoff-sound electronic blood pressure (BP) monitor in the adult population, in accordance with the ISO 81060-2:2018. A total of 90 participants were recruited for this clinical study. After excluding 3 individuals due to excessive BP variability, the remaining 87 participants were enrolled for the evaluation. All enrolled participants met the inclusion criteria, which specified ranges for arm circumference, SBP, and DBP. According to ISO 81060-2:2018 + Amd 1:2020, the mean ± SD of the differences between the test device and the reference BP measurements were -0.3 ± 2.35/-0.3 ± 1.72 mmHg (SBP/DBP), thus meeting the requirements of Criterion 1 (≤5 mmHg mean difference and ≤8 mmHg SD). The mean difference in SBP was -0.3 ± 1.11 mmHg, while that in DBP was -0.3 ± 0.90 mmHg; this also fulfilled the requirements of Standard 2, with standard deviations within the limits of ≤6.95 mmHg for both SBP and DBP. Both ISO criteria were therefore satisfied, showing that the Hanvon KSY3600 Korotkoff-sound electronic BP monitor conforms to the ISO 81060-2:2018 + Amd 1:2020. It can thus be recommended for BP measurements in adults, both in clinical settings and for home use.
BACKGROUND:Atrial fibrillation is one of the most common cardiac arrhythmias. It is a condition that significantly increases the risk of stroke and cardiac complications, making its early diagnosis and intervention a crucial part of improving long-term patient prognosis. This study evaluates the accuracy of an atrial fibrillation detection algorithm in a Korotkoff sound blood pressure (BP) monitor. METHODS:A total of 312 inpatients and outpatients were recruited for this study, with a Korotkoff sound BP monitor used to measure the BP and screen for atrial fibrillation. The study cohort included 148 patients with atrial fibrillation (mean age 73.3 ± 9.0 years) and 164 controls with sinus rhythm (mean age 44.7 ± 14.6 years). During BP measurement, a hand-held single-lead ECG device was used to simultaneously record ECGs for evaluating the accuracy of the atrial fibrillation detection algorithm. RESULTS:The device accurately identified all 148 confirmed atrial fibrillation patients, reliably triggering 'AFib' alerts in every instance. Throughout the evaluation of 164 non-atrial fibrillation subjects, the device maintained perfect specificity with zero false positive events. These results demonstrate 100% sensitivity and 100% specificity for atrial fibrillation detection. CONCLUSION:The Korotkoff sound BP monitor with atrial fibrillation detection algorithm exhibits excellent diagnostic accuracy. This device is of significant clinical value for early atrial fibrillation screening, serving as a convenient, efficient, and reliable tool for both home and primary medical institutions. Its capability for timely atrial fibrillation detection may contribute to reduced risks of stroke and other atrial fibrillation-related cardiovascular complications.
OBJECTIVE:The aim of this study was to evaluate the accuracy of the B.Well TH-75 oscillometric upper-arm blood pressure (BP) monitor in general population according to the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018+Amd1 : 2020+Amd2 : 2024), and the device is expected to be used for home BP monitoring, with its measurements serving as a clinical reference. METHODS:Subjects were recruited among the adult population to fulfill the age, gender, BP, and cuff distributions of the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018+Amd1 : 2020+Amd2 : 2024), and the study was approved by the Ethics Committee of the hospital. A single cuff 22-42 cm was used on the B.Well TH-75, and the validation was performed using the same-arm sequential BP measurement method. RESULTS:Data from 85 subjects were analyzed. According to Criterion 1, the mean difference of systolic blood pressure (SBP) and diastolic blood pressure (DBP) between the test and reference device was 2.36 ± 7.40 and 0.85 ± 6.47 mmHg, respectively, which met the requirements of less than 5 and 8 mmHg for mean difference and SD, respectively. According to Criterion 2, SD of SBP was 6.20 mmHg, which was less than 6.51 mmHg and met the requirements. The SD of DBP was 5.28 mmHg, which was less than 6.88 mmHg and met the requirements. CONCLUSION:The B.Well TH-75 upper-arm BP monitor fulfilled the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018+Amd1 : 2020+Amd2 : 2024) and can be recommended for use in general population.
