Blood Pressure Monitoring最新文献

{"title":"Oscillometric blood pressure measurement using a wide-range cuff from 22 to 41 cm of arm circumference: validation of the Hingmed V03D upper arm blood pressure monitor in a general population.","authors":"Wei Han, Renbao Li, Jiao Yang, Hui He, Le Yang, Paolo Palatini","doi":"10.1097/MBP.0000000000000809","DOIUrl":"10.1097/MBP.0000000000000809","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"253-257"},"PeriodicalIF":1.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148337621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of the novel professional automated auscultatory upper-arm cuff blood pressure monitor KOROT V2 Doctor (KOROT P2) in a pediatric population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018).","authors":"Ariadni Menti, Aikaterini Theodosiadi, Vasileios Ntousopoulos, Eirini Chrysovalanti Antonogiannaki, Anastasios Kollias, George S Stergiou","doi":"10.1097/MBP.0000000000000829","DOIUrl":"10.1097/MBP.0000000000000829","url":null,"abstract":"<p><strong>Objective: </strong>The novel automated auscultatory upper arm-cuff blood pressure (BP) monitor KOROT V2 Doctor (KOROT P2) has been successfully validated for professional use in the general population with three cuff sizes (23-28, 28-35, and 33-42 cm). The device provides automated measurements of BP using an electronic stethoscope embedded in the cuff, which records and displays Korotkoff sounds during deflation, allowing visual assessment by the healthcare professional. The device is also equipped with pediatric cuffs, and this study aimed to evaluate the device's accuracy in children.</p><p><strong>Methods: </strong>The requirements of the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) were applied. Three cuffs of the test device were tested for arm circumference 15-18, 18-23, and 23-28 cm.</p><p><strong>Results: </strong>Data from 35 individuals were analyzed [mean age: 8.7 ± 2.2 (SD) years, 18 boys, arm circumference: 15.1-28 cm]. For Validation Criterion 1, the mean difference ±SD between the test device and reference BP readings ( N  = 105) was 0.7 ± 5.1/0.4 ± 6.2 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Validation Criterion 2, the SD of the averaged BP differences between the test and reference BP readings per individual was 3.92/4.78 mmHg (systolic/diastolic; threshold ≤6.90/6.93 mmHg).</p><p><strong>Conclusion: </strong>The KOROT V2 Doctor (KOROT P2) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a pediatric population and can be recommended for clinical use.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical validation of the MED-58 upper-arm automated oscillometric blood pressure monitor with fan-shaped and rigid cuffs for home and clinical use in adolescents and adults, according to International Organization for Standardization 81060-2:2018 (Amd.1:2020; Amd.2:2024): a single-center prospective study.","authors":"HongYun Ma, JingZhen Liu, MengYa Chen, QianHui Yao","doi":"10.1097/MBP.0000000000000826","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000826","url":null,"abstract":"<p><p>This study validated the accuracy and safety of the MED-58 upper-arm automated oscillometric blood pressure monitor - intended for home and clinical use - with fan-shaped and rigid cuffs, per International Organization for Standardization (ISO) 81060-2:2018 (Amd.1:2020; Amd.2:2024). In this prospective, single-center validation study, participants aged ≥12 years were allocated to a fan-shaped cuff group (n = 85) or a rigid cuff group (n = 85). Per group, oscillometric readings with the MED-58 were compared with reference auscultatory measurements using the same-arm sequential method in ISO 81060-2. Blood pressure accuracy was assessed against ISO criterion 1 and 2. Secondary endpoints included pulse rate accuracy (±5% margin vs. manual palpation), device usability/performance, and safety. Both cuff configurations met ISO accuracy requirements. In the fan-shaped group, mean (±SD) device-reference differences were 1.1 ± 5.4 mmHg (SBP) and 0.3 ± 4.0 mmHg (DBP); SDs of per-participant mean differences were 4.4 mmHg (SBP) and 3.3 mmHg (DBP). In the rigid group, mean differences were 0.8 ± 5.2 mmHg (SBP) and 0.6 ± 4.5 mmHg (DBP); SDs of per-participant mean differences were 4.2 mmHg (SBP) and 3.8 mmHg (DBP). Mean pulse-rate differences were 1.65 bpm (fan-shaped) and 1.76 bpm (rigid), both within the prespecified ±5% equivalence margin. No adverse events were reported. The MED-58 demonstrated accuracy consistent with ISO 81060-2:2018 (Amd.1:2020; Amd.2:2024) with either cuff, with good usability and short-term safety.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical validation of MESI mTABLET BP according to ISO 81060-2:2018 + A1 + A2.","authors":"Jaka Strel, Metka Križič, Biljana Nikolova Stoilova, Ivan Pecev, Rebeka Novak, Matija Kiker, Tinkara Royal Mlinar","doi":"10.1097/MBP.0000000000000825","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000825","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to clinically validate the MESI mTABLET BP device in accordance with the protocol outlined in ISO 81060-2:2018 + A1 + A2.</p><p><strong>Methods: </strong>A total of 127 adult participants were enrolled, of whom 36 were excluded. The final study sample consisted of 91 participants with upper arm circumferences ranging from 22 to 50 cm. Blood pressure measurements obtained with the MESI mTABLET BP were compared with reference auscultatory measurements performed simultaneously by two trained observers. A same-arm sequential method was used, in which each MESI mTABLET BP measurement was compared against the average of the preceding and subsequent reference measurements. The study was approved by the National Medical Ethics Committee of the Republic of Slovenia.</p><p><strong>Results: </strong>The mean blood pressure difference between MESI mTABLET BP and the reference auscultatory method was 1.6 ± 4.3 mmHg for SBP and 1.9 ± 5.1 mmHg for DBP; hence, criterion 1 from the standard was fulfilled (required |mean| ≤5.00, SD ≤8.00 mmHg). Criterion 2 was also met, as the SD of average paired determinations per participant was ±3.56 mmHg for SBP and ±4.66 mmHg for DBP (required ≤6.76 and ≤6.68 mmHg, respectively).</p><p><strong>Conclusion: </strong>The MESI mTABLET BP demonstrated clinical accuracy and reliability, and can hence be recommended for use in clinical and primary care settings in adult populations with upper arm circumferences between 22 and 50 cm, as validated in the present study.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between severity of obstructive sleep apnea and ambulatory arterial stiffness index in a Chinese population.","authors":"Yi-Cheng Wu, Ming-Jing Wang, Hui-Xin Wang","doi":"10.1097/MBP.0000000000000822","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000822","url":null,"abstract":"<p><strong>Background: </strong>The purpose of the current study was to determine the correlation between the apnea-hypopnea index (AHI) and ambulatory arterial stiffness index (AASI) in patients with obstructive sleep apnea hypopnea syndrome (OSAHS).</p><p><strong>Methods: </strong>A total of 201 patients with OSAHS admitted to Zhongshan Hospital (Xiamen), Fudan University from January 2021 to October 2023 were selected and divided into two groups based on the AHI (mild-to-moderate and severe groups). All patients completed the general data collection, portable sleep monitoring, and dynamic blood pressure monitoring. One-way analysis of variance was used to compare the general clinical characteristics between groups with OSAHS of different severity. Correlation analysis was used to compare the correlation between AASI and portable sleep monitoring parameters. Multiple linear regression analysis was used to determine the correlation between AASI and portable sleep monitoring parameters.</p><p><strong>Results: </strong>Patients with severe OSAHS exhibited significantly higher BMI, uric acid levels, and AASI compared with the mild-to-moderate group (P < 0.05). Multiple linear regression analysis revealed that age, AHI, and the percentage of total time with oxygen saturation level less than 90% (T90) were independently and positively associated with AASI (P < 0.05), while the estimated glomerular filtration rate showed a negative association. Notably, age and the degree of nocturnal hypoxemia (T90) showed a more clinically significant association with arterial stiffness than AHI.</p><p><strong>Conclusion: </strong>There was a correlation between OSAHS severity and the AASI, and the degree of arteriosclerosis in OSAHS patients increased with an increase in the AHI, although age and hypoxic burden were the primary drivers of arterial stiffness.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of the LD-526 brachial blood pressure monitor according to the International Organization for Standardization protocol (ISO 81060-2:2018/AMD 1:2020/AMD 2:2024).","authors":"Yi Zhou, Xin-Yu Wang, Ruo-Yi Zou, Ji-Guang Wang","doi":"10.1097/MBP.0000000000000824","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000824","url":null,"abstract":"<p><strong>Objective: </strong>The LD-526 oscillometric upper-arm blood pressure (BP) monitor is intended for self-measurement of BP in adults. The aim of this study was to evaluate the accuracy of LD-526 oscillometric upper-arm BP monitor in the general population according to the International Organization for Standardization (ISO) universal standard (ISO 81060-2 : 2018/AMD 1 : 2020/AMD 2 : 2024).</p><p><strong>Method: </strong>Subjects were recruited to fulfill the age, gender, BP, and cuff distributions of the ISO universal standard in the general population using the same-arm sequential BP measurement method. The test device was used with one universal cuff for arm circumferences of 22-42 cm. Reference BP measurements were obtained using a calibrated mercury sphygmomanometer, with two cuffs (inflatable bladder sizes of 12 × 24 and 16 × 32 cm, respectively).</p><p><strong>Results: </strong>Of the 98 recruited subjects, 85 [women/men: 46/39; mean (±SD) age: 52.2 ± 17.4 years] were analyzed, and 13 were excluded from the final analysis: 10 because of reference BP variability and three because of cardiac arrhythmias. For validation of criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.34 ± 5.56/-0.31 ± 4.36 mmHg (systolic/diastolic). For criterion 2, the SD of the average BP differences between the test device and reference BP per subject was 4.51/3.77 mmHg (systolic/diastolic).</p><p><strong>Conclusion: </strong>The LD-526 BP monitor fulfilled all the requirements of the ISO universal standard (ISO 81060-2 : 2018/AMD 1 : 2020/AMD 2 : 2024) in the general population and can be recommended for self-measurement.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of home-based isometric handgrip or aerobic training on blood pressure variability and vascular health in older adults with elevated blood pressure and hypertension: secondary results from The HoldAge Trial.","authors":"Diogo Pinto, Nuno Dias Rato, Catarina Garcia, Manuel Teixeira, Maria J Marques, Teresa Amaral, Leonor Amaral, Ricardo Abreu, Cristiana Carneiro, Ana P Oliveira, Daniela Figueiredo, Jorge Polónia, José Mesquita-Bastos, João L Viana, Linda S Pescatello, Fernando Ribeiro, Alberto J Alves","doi":"10.1097/MBP.0000000000000820","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000820","url":null,"abstract":"<p><strong>Background: </strong>Hypertension is a multifactorial condition that is likely to affect older adults. We evaluated the effects of home-based isometric handgrip training (IHT) or aerobic exercise training (AET) on vascular health of older adults with elevated blood pressure (BP) and hypertension.</p><p><strong>Methods: </strong>The HoldAge trial (NCT04275032) was a two-center prospective randomized controlled trial. Eighty-four participants (46 women, 71.1 ± 3.6 years, BP: 137.1 ± 13.8/80.8 ± 8.3 mmHg) were randomized into IHT, AET, or usual medical care. Participants performed IHT or AET three times/week for 8 weeks. IHT consisted of 4 × 45 bilateral contractions at 50% of maximum voluntary contraction with 1-min rest between sets. AET consisted of walking 30 min at 50-70% of maximum oxygen consumption. Usual medical care received standard medical care. Outcome comprised blood pressure variability (BPV), flow-mediated dilation (FMD), aortic pulse wave velocity (aoPWV), and endothelial function and inflammation biomarkers.</p><p><strong>Results: </strong>No significant group × time interaction effects occurred for 24-h and daytime BPV, FMD, aoPWV, and circulating biomarkers (P > 0.05). A significant group × time interaction occurred for nighttime systolic BPV (P = 0.005). IHT decreased nighttime systolic BPV over time (-1.5 ± 3.0 mmHg; P = 0.011), while AET (1.1 ± 2.9 mmHg; P = 0.064) and usual medical care (0.6 ± 2.7 mmHg; P = 0.344) did not.</p><p><strong>Conclusion: </strong>Home-based IHT effectively reduces nighttime systolic BPV in older adults with elevated BP and hypertension, suggesting it could serve as a valuable nonpharmacological strategy to improve vascular health.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148839012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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.","authors":"Xiaojing Guo","doi":"10.1097/MBP.0000000000000818","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000818","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical investigation of the iHealth Track KN-550BT upper-arm blood pressure monitor in pregnant patients according to the ISO 81060-2:2018+AMD1:2020/AMD2:2024.","authors":"Ying Zhang, Dongmei Wang, Chunmei Cui, Yu Zhang, Jieqiong Zhang, Yi Wan","doi":"10.1097/MBP.0000000000000817","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000817","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of the Omron HEM-7380T (HCR-7728T) blood pressure monitor in the general population according to the international organization for standardization 81060-2:2018 + Amd.1:2020 and Amd.2:2024.","authors":"Hakuo Takahashi, Nobuki Yakura, Mitsuo Kuwabara","doi":"10.1097/MBP.0000000000000803","DOIUrl":"10.1097/MBP.0000000000000803","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to validate the accuracy of Omron HEM-7380T (HCR-7728T), an automated deflationary oscillometric upper-arm blood pressure (BP) monitor, according to the international organization for standardization (ISO) 81060-2 : 2018 + Amd1 : 2020 and Amd2 : 2024 protocols (ISO standards).</p><p><strong>Methods: </strong>Accuracy was assessed by alternately measuring systolic BP (SBP) and diastolic BP (DBP) in the same arm using the test device and a mercury sphygmomanometer. All participants met the inclusion criteria outlined in the protocol.</p><p><strong>Results: </strong>A total of 85 patients were included (43 males and 42 females), with a mean age of 63.9 ± 10.3 years and a mean arm circumference of 26.7 ± 5.4 cm. Regarding Criterion 1, the mean ± SD of the differences between the test device and reference BP was 0.1 ± 6.85 mmHg for SBP and 0.9 ± 5.41 mmHg for DBP, fulfilling the ISO requirement of less than or equal to 5 ± less than or equal to 8 mmHg. For Criterion 2, the SD values were 0.1 ± 5.69 mmHg for SBP and 0.9 ± 4.95 mmHg for DBP, satisfying the required thresholds of less than or equal to 6.95and less than or equal to 6.88, respectively. The results indicated that this device conforms to the ISO standards.</p><p><strong>Conclusion: </strong>Omron HEM-7380T fulfilled criteria 1 and 2 of the protocol. Therefore, the device is considered sufficiently accurate for BP measurements in the general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"181-184"},"PeriodicalIF":1.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147761168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}