{"title":"根据 ANSI/AAMI/ISO 81060-2:2018/Amd1:2020，在普通人群中验证 AViTA 上臂式血压计 BP636 的多种袖带尺寸。","authors":"Chung-Yu Lin, I-Chih Huang","doi":"10.1097/MBP.0000000000000722","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).</p><p><strong>Methods: </strong>The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.</p><p><strong>Results: </strong>For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, which was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).</p><p><strong>Conclusion: </strong>AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"321-326"},"PeriodicalIF":1.2000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11524622/pdf/","citationCount":"0","resultStr":"{\"title\":\"Validation of the AViTA upper-arm blood pressure monitor BP636 with multiple cuff sizes in the general population according to the ANSI/AAMI/ISO 81060-2:2018/Amd1:2020.\",\"authors\":\"Chung-Yu Lin, I-Chih Huang\",\"doi\":\"10.1097/MBP.0000000000000722\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).</p><p><strong>Methods: </strong>The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.</p><p><strong>Results: </strong>For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, which was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).</p><p><strong>Conclusion: </strong>AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.</p>\",\"PeriodicalId\":8950,\"journal\":{\"name\":\"Blood Pressure Monitoring\",\"volume\":\" \",\"pages\":\"321-326\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11524622/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Blood Pressure Monitoring\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MBP.0000000000000722\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood Pressure Monitoring","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MBP.0000000000000722","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/9 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Validation of the AViTA upper-arm blood pressure monitor BP636 with multiple cuff sizes in the general population according to the ANSI/AAMI/ISO 81060-2:2018/Amd1:2020.
Objective: To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).
Methods: The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.
Results: For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, which was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).
Conclusion: AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.
期刊介绍：
Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research.
This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine.
Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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