{"title":"Validation of the Raycome model M2 ambulatory blood pressure monitor in the general 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":"Shijie Yang, Zhanyang Zhou, Huanhuan Miao, Hongye Zhang, Qiong Zhou, Mei Zhai, Yuqing Zhang","doi":"10.1097/MBP.0000000000000697","DOIUrl":"10.1097/MBP.0000000000000697","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in the general population according to 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) at rest and during dynamic exercise.</p><p><strong>Method: </strong>Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large).</p><p><strong>Results: </strong>For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.5 ± 6.2/-0.2 ± 5.1 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50 mmHg (systolic/diastolic). In the ambulatory validation study ( N = 35), the mean difference was 0.4 ± 5.9/-1.1 ± 5.8 mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error.</p><p><strong>Conclusion: </strong>These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"161-165"},"PeriodicalIF":1.3,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11045396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood Pressure MonitoringPub Date : 2024-06-01Epub Date: 2024-04-24DOI: 10.1097/MBP.0000000000000695
Maosheng Yan, Hanjun Zheng, Qian Liu, Bin Xiao, Chengmin Wang, Yanxia Jia, Siyu Pan
{"title":"Microvascular abnormalities induced by hand-transmitted vibration reflects in finger systolic blood pressure: a cross-sectional study in China.","authors":"Maosheng Yan, Hanjun Zheng, Qian Liu, Bin Xiao, Chengmin Wang, Yanxia Jia, Siyu Pan","doi":"10.1097/MBP.0000000000000695","DOIUrl":"10.1097/MBP.0000000000000695","url":null,"abstract":"<p><strong>Objective: </strong>Local vibration can cause microcirculatory abnormalities such as blood stasis and symmetrical intermittent digital artery vasospasm. Finger SBP (FSBP) measurement is a potential way of assessing vascular components. This study aims to comprehensively investigate the relationship between the occurrence of the vibration-induced white finger (VWF) and changes in FSBP and then set the application value of FSBP measurements in the early diagnosis of VWF.</p><p><strong>Methods: </strong>All samples were judgmental sampling from one factory. Totally 50 patients with VWF were the case group, while 50 without occupational hand-transmitted vibration exposure were the control group. FSBP measurements and epidemiological feature investigations were taken.</p><p><strong>Results: </strong>There were significant reductions in FSBP level and %FSBP index at both 10 °C and 30 °C in fingers reported VWF ( P < 0.05). The %FSBP abnormal rate of the index, ring and little finger in the VWF group was higher than the control (44.00% vs. 18.00%, 78.00% vs. 26.00%, 64.00% vs. 8.00%). The %FSBP of the ring and little finger had a relatively high application value (area under curve = 0.902, 0.737), while their standard regression coefficients were -0.23 and -0.412. The diagnostic cutoff value of the ring finger was 77.60%, while the sensitivity and specificity were 86.67%.</p><p><strong>Conclusion: </strong>FSBP measurements were proven helpful in monitoring and diagnosing VWF prospectively and proved to have great application value in our study. %FSBP of the ring finger was the appropriate diagnostic index in FSBP measurements, while its abnormal value could be set as 80.00%.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"136-143"},"PeriodicalIF":1.3,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11045399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood Pressure MonitoringPub Date : 2024-06-01Epub Date: 2024-04-24DOI: 10.1097/MBP.0000000000000694
Yi Wan, Duan Li, Jin-Feng Chen, Yang Zhang
{"title":"Validation of noninvasive blood pressure monitoring function of EDAN elite V5 patient monitor with reference invasive measurement according to the ISO 81060-2:2018 standard.","authors":"Yi Wan, Duan Li, Jin-Feng Chen, Yang Zhang","doi":"10.1097/MBP.0000000000000694","DOIUrl":"10.1097/MBP.0000000000000694","url":null,"abstract":"<p><strong>Objective: </strong>To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard.</p><p><strong>Methods: </strong>Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.</p><p><strong>Results: </strong>A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.</p><p><strong>Conclusion: </strong>The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"156-160"},"PeriodicalIF":1.3,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139970904","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}
Blood Pressure MonitoringPub Date : 2024-06-01Epub Date: 2024-02-23DOI: 10.1097/MBP.0000000000000696
Claudio Fania, Antonella Giletto, Alice Niero, Paolo Palatini
{"title":"Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms.","authors":"Claudio Fania, Antonella Giletto, Alice Niero, Paolo Palatini","doi":"10.1097/MBP.0000000000000696","DOIUrl":"10.1097/MBP.0000000000000696","url":null,"abstract":"<p><strong>Objective: </strong>To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol.</p><p><strong>Methods: </strong>The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard.</p><p><strong>Results: </strong>The mean BP difference between the device and the observers' reference measurements was 1.2 ± 2.0 mmHg for systolic BP and 1.0 ± 2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle.</p><p><strong>Conclusions: </strong>These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"144-148"},"PeriodicalIF":1.3,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929921","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}
Blood Pressure MonitoringPub Date : 2024-06-01Epub Date: 2024-04-24DOI: 10.1097/MBP.0000000000000688
Guocun Hou, Yulu Wu, Jiaying Wang, Jia Zhi
{"title":"Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020).","authors":"Guocun Hou, Yulu Wu, Jiaying Wang, Jia Zhi","doi":"10.1097/MBP.0000000000000688","DOIUrl":"10.1097/MBP.0000000000000688","url":null,"abstract":"<p><p>To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"149-155"},"PeriodicalIF":1.3,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11045392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood Pressure MonitoringPub Date : 2024-04-01Epub Date: 2023-11-15DOI: 10.1097/MBP.0000000000000685
Ayumi Toba, Joji Ishikawa, Kazumasa Harada
{"title":"Automated office blood pressure measurement with the assistance of an instructional video in patients with hypertension.","authors":"Ayumi Toba, Joji Ishikawa, Kazumasa Harada","doi":"10.1097/MBP.0000000000000685","DOIUrl":"10.1097/MBP.0000000000000685","url":null,"abstract":"<p><strong>Objectives: </strong>Automated office blood pressure (AOBP) measurement often requires assistance. Accompanied by an instructional video, AOBP measurement could be performed independently by patients.</p><p><strong>Design and methods: </strong>Seventy-five patients with hypertension were enrolled. AOBP was measured three times at 1-min intervals after 5 min of rest by an automated BP measurement device with the assistance of an animated instructional video. The video was designed originally to instruct patients on the way to measure BP appropriately. Perceived stress was evaluated using a questionnaire after the AOBP measurement. Office BP was measured three times using the same device. Home BP measurement was performed on 5 consecutive days.</p><p><strong>Results: </strong>The mean age of the patients was 74.5 ± 10.6 years, and 96% were taking antihypertensive drugs. Mean AOBP, office BP and home BP measurements were 135.2 ± 17.2/81.3 ± 11.1, 139.3 ± 16.3/78.6 ± 10.9 and 129.2 ± 16.7/72.7 ± 8.9 mmHg, respectively. Regarding SBP, the mean AOBP was significantly lower than office BP ( P = 0.005) and higher than home BP ( P = 0.004). The differences in SBP and DBP between AOBP and home BP measurements were significantly related to patients' perceived stress when performing AOBP measurements ( r = 0.289; P = 0.013 and r = 0.328; P = 0.004). In a multivariate analysis, patients' perceived stress was a significant predictor of the difference between AOBP and home BP ( P = 0.013), even after adjusting for age, sex, BMI and mean of AOBP and home BP.</p><p><strong>Conclusion: </strong>AOBP values measured with the assistance of an instructional video were between conventional office and home BP measurements. Perceived stress during AOBP measurement was related to the difference in AOBP from home BP.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"63-70"},"PeriodicalIF":1.3,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138298253","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}
Blood Pressure MonitoringPub Date : 2024-04-01Epub Date: 2023-12-14DOI: 10.1097/MBP.0000000000000686
Kui Liu, Dan Wu, Sen Bing, Lin-Yi Li
{"title":"Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard.","authors":"Kui Liu, Dan Wu, Sen Bing, Lin-Yi Li","doi":"10.1097/MBP.0000000000000686","DOIUrl":"10.1097/MBP.0000000000000686","url":null,"abstract":"<p><strong>Objective: </strong>To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.</p><p><strong>Methods: </strong>Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard.</p><p><strong>Results: </strong>For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively.</p><p><strong>Conclusion: </strong>The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"103-106"},"PeriodicalIF":1.3,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401673","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}
Blood Pressure MonitoringPub Date : 2024-04-01Epub Date: 2024-01-15DOI: 10.1097/MBP.0000000000000690
Odilon Abrahin, Rejane Pequeno Abrahin, Mayko Guimarães, Vitor Bruno Teixeira de Holanda, Fernanda Andreza De Pinho Lott Figueiredo, Bruno Viana Rosa, Ivo Vieira de Sousa Neto, Nicholas Rolnick, Gislane Ferreira de Melo, Emanuelle Fernandes Prestes, Dahan da Cunha Nascimento
{"title":"Blood pressure responsiveness to resistance training in the hypertensive older adult: a randomized controlled study.","authors":"Odilon Abrahin, Rejane Pequeno Abrahin, Mayko Guimarães, Vitor Bruno Teixeira de Holanda, Fernanda Andreza De Pinho Lott Figueiredo, Bruno Viana Rosa, Ivo Vieira de Sousa Neto, Nicholas Rolnick, Gislane Ferreira de Melo, Emanuelle Fernandes Prestes, Dahan da Cunha Nascimento","doi":"10.1097/MBP.0000000000000690","DOIUrl":"10.1097/MBP.0000000000000690","url":null,"abstract":"<p><p>Different lifestyle changes have been employed to improve clinical hypertension. However, there is scarce evidence on the blood pressure responsiveness to resistance training (RT) in hypertensive older adults. Consequently, little is known about some participants clinically reducing blood pressure and others not. Thus, we investigate the effects and responsiveness of RT on blood pressure in hypertensive older adults. We secondarily evaluated the biochemical risk factors for cardiovascular disease and functional performance. Older participants with hypertension were randomly assigned into RT (n = 27) and control group (n = 25). Blood pressure, functional performance (timed up and go, handgrip strength, biceps curl and sit-to-stand), fasting glucose, and lipid profiles were evaluated preintervention and postintervention. The statistic was performed in a single-blind manner, the statistician did not know who was the control and RT. RT was effective in reducing systolic blood pressure (SBP) (pre 135.7 ± 14.7; post 124.7 ± 11.0; P < 0.001) and the responses to RT stimuli varied noticeably between hypertensive older adults after 12 weeks. For example, 13 and 1 responders displayed a minimal clinical important difference for SBP attenuation (10.9 mmHg) in the RT and control groups, respectively. RT improved the functional performance of older people with hypertension, while no differences were found in biochemical parameters (triglycerides, HDL, LDL, fasting glucose) after 12 weeks. In conclusion, responses to RT stimuli varied noticeably between hypertensive individuals and RT was effective in reducing SBP.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"71-81"},"PeriodicalIF":1.3,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650279","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}
Blood Pressure MonitoringPub Date : 2024-04-01Epub Date: 2024-02-28DOI: 10.1097/MBP.0000000000000687
Jigar Patel, Hasan Zia, David F Lo
{"title":"Analyzing key genetic and comorbid factors on the efficacy of digital therapeutics for treating high blood pressure.","authors":"Jigar Patel, Hasan Zia, David F Lo","doi":"10.1097/MBP.0000000000000687","DOIUrl":"10.1097/MBP.0000000000000687","url":null,"abstract":"","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":"29 2","pages":"107-108"},"PeriodicalIF":1.3,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989256","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}
Blood Pressure MonitoringPub Date : 2024-04-01Epub Date: 2023-11-06DOI: 10.1097/MBP.0000000000000682
Ariadni Menti, Vasileios Ntousopoulos, Aikaterini Theodosiadi, Panagiota Stathopoulou, Anastasios Kollias, George S Stergiou
{"title":"Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.","authors":"Ariadni Menti, Vasileios Ntousopoulos, Aikaterini Theodosiadi, Panagiota Stathopoulou, Anastasios Kollias, George S Stergiou","doi":"10.1097/MBP.0000000000000682","DOIUrl":"10.1097/MBP.0000000000000682","url":null,"abstract":"<p><strong>Objective: </strong>This study evaluated the accuracy of the automated oscillometric upper-arm cuff device AVITA BPM82 intended for home use in a general population according to 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 Amendment 1.2020-01.</p><p><strong>Methods: </strong>Participants were recruited to fulfill the age, sex, blood pressure (BP), and limb distribution criteria of the AAMI/ESH/ISO Universal Standard and its Amendment 1.2020-01 in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-33 (medium) and 33-42 cm (large).</p><p><strong>Results: </strong>One-hundred-one individuals were recruited and 85 were analyzed [mean age 57.3 ± 15.1 (SD) years, 46 men, arm circumference 32 ± 5.1 cm, range 22.3-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was 1.3 ± 6.5/3.6 ± 5.9 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual (N = 85) was 5.70/5.25 mmHg (systolic/diastolic; threshold ≤6.82/5.89 mmHg).</p><p><strong>Conclusions: </strong>The automated oscillometric home BP monitor AVITA BPM82 comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 in a general population and can be recommended for clinical use.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"89-92"},"PeriodicalIF":1.3,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71477600","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}