Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Prolife PA5 Comfort AF (BP 136A) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
Ariadni Menti, Vasileios Ntousopoulos, Petroula Lempidaki, Konstantina-Rozalia Bakalakou, Dimitrios Mariglis, Aikaterini Komnianou, Evangelia Ntaskagianni, Anastasios Kollias, George S Stergiou
{"title":"Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Prolife PA5 Comfort AF (BP 136A) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.","authors":"Ariadni Menti, Vasileios Ntousopoulos, Petroula Lempidaki, Konstantina-Rozalia Bakalakou, Dimitrios Mariglis, Aikaterini Komnianou, Evangelia Ntaskagianni, Anastasios Kollias, George S Stergiou","doi":"10.1097/MBP.0000000000000793","DOIUrl":null,"url":null,"abstract":"<p><p>This study evaluated the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) measuring device Prolife PA5 Comfort AF (BP 136A) 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 amendments (1 : 2020 and 2 : 2024). The requirements of the Universal Standardand its amendments for a validation study in a general population using the same arm sequential measurement method were applied. Participants were recruited to fulfill the age, sex, BP level, arm circumference, and cuff size distribution criteria. The test device measures BP during inflation and uses a wide-range cuff for arm circumference 22-42 cm. One-hundred-twenty-eight individuals were recruited and 85 were analyzed [mean age: 54.9 ± 15.0 (SD) years, 36 (42%) men, arm circumference: 31.7 ± 5.4 cm, range: 22.5-41.9 cm). For validation Criterion 1, the mean difference ± SD between the test device and reference BP readings ( N = 255) was -2.1 ± 7.5/-0.3 ± 5.3 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) were 6.44/5.07 mmHg (systolic/diastolic; threshold: ≤6.62/6.95 mmHg). The automated oscillometric home BP monitor Prolife PA5 Comfort AF (BP 136A) fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024) for a general population and can be recommended for clinical use.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"149-152"},"PeriodicalIF":1.0000,"publicationDate":"2026-06-01","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.0000000000000793","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
Abstract
This study evaluated the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) measuring device Prolife PA5 Comfort AF (BP 136A) 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 amendments (1 : 2020 and 2 : 2024). The requirements of the Universal Standardand its amendments for a validation study in a general population using the same arm sequential measurement method were applied. Participants were recruited to fulfill the age, sex, BP level, arm circumference, and cuff size distribution criteria. The test device measures BP during inflation and uses a wide-range cuff for arm circumference 22-42 cm. One-hundred-twenty-eight individuals were recruited and 85 were analyzed [mean age: 54.9 ± 15.0 (SD) years, 36 (42%) men, arm circumference: 31.7 ± 5.4 cm, range: 22.5-41.9 cm). For validation Criterion 1, the mean difference ± SD between the test device and reference BP readings ( N = 255) was -2.1 ± 7.5/-0.3 ± 5.3 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) were 6.44/5.07 mmHg (systolic/diastolic; threshold: ≤6.62/6.95 mmHg). The automated oscillometric home BP monitor Prolife PA5 Comfort AF (BP 136A) fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024) for a general population and can be recommended for clinical use.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
