Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Lei Wang, Ju-Yun Li, Zhong-Qun Zhan
{"title":"根据 AAMI/ESH/ISO 通用标准（ISO 81060- 2:2018/AMD 1:2020）对 JAMR 上臂压力监测仪 B23 进行验证。","authors":"Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Lei Wang, Ju-Yun Li, Zhong-Qun Zhan","doi":"10.1097/MBP.0000000000000719","DOIUrl":null,"url":null,"abstract":"<p><p>The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":null,"pages":null},"PeriodicalIF":1.2000,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of the JAMR upper-arm pressure monitor B23 according to the AAMI/ESH/ISO Universal Standard (ISO 81060- 2:2018/AMD 1:2020).\",\"authors\":\"Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Lei Wang, Ju-Yun Li, Zhong-Qun Zhan\",\"doi\":\"10.1097/MBP.0000000000000719\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.</p>\",\"PeriodicalId\":8950,\"journal\":{\"name\":\"Blood Pressure Monitoring\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-07-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Blood Pressure Monitoring\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MBP.0000000000000719\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"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.0000000000000719","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Validation of the JAMR upper-arm pressure monitor B23 according to the AAMI/ESH/ISO Universal Standard (ISO 81060- 2:2018/AMD 1:2020).
The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.
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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