Validation of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) and the International Organization for Standardization Amendment 1. 2020.
Journal
Blood pressure monitoring
ISSN: 1473-5725
Titre abrégé: Blood Press Monit
Pays: England
ID NLM: 9606438
Informations de publication
Date de publication:
01 Oct 2023
01 Oct 2023
Historique:
medline:
11
9
2023
pubmed:
29
6
2023
entrez:
29
6
2023
Statut:
ppublish
Résumé
To evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure (BP) monitor in general population (for clinic and home BP measurements in adults) 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. Subjects were recruited to fulfill the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-32 cm (standard) and 22-45 cm (wide range). Ninety-two subjects were recruited and 85 subjects were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.3 ± 7.2/2.2 ± 5.5 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 6.1/4.8 mmHg (systolic/diastolic). The YuWell YE660D oscillometric upper-arm electronic BP monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its Amendment 1. 2020 in adults and hence can be recommended for home and clinical use.
Identifiants
pubmed: 37382148
doi: 10.1097/MBP.0000000000000658
pii: 00126097-202310000-00007
doi:
Banques de données
ClinicalTrials.gov
['NCT number']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
276-279Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Références
Stergiou GS, Palatini P, Parati G, O’Brien E, Januszewicz A, Lurbe E, et al.; European Society of Hypertension Council and the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens 2021; 39:1293–1302.
Chen Q, Lei L, Li Y, Wang JG. Validation of the YuWell YE690A upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit 2017; 22:295–297.
International Organization for Standardization. ISO 81060-2:2018. Non-invasive sphygmomanometers-Part 2: clinical investigation of intermittent automated measurement type. https://www.iso.org/standard/73339.html . [Accessed 3 May 2022]
Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, et al.; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens 2019; 37:459–466.
International Organization for Standardization. ISO 81060-2:2018/Amd 1:2020. Non-invasive sphygmomanometers – Part 2: clinical investigation of intermittent automated measurement type – Amendment 1. https://www.iso.org/standard/75432.html . [Accessed 5 May 2022]
Zhang HJ, Zhang J, Wang SL, Zhang J, Teng LN, Zhang SJ, et al. Validation of the YuWell YE900 oscillometric blood pressure monitor for professional office use in adults and children according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). Blood Press Monit 2021; 26:396–399.