VALIDATION OF THE IHEALTH AMBULATORY BLOOD PRESSURE MONITOR IN ADULTS ACCORDING TO THE ANSI/AAMI/ISO 2013 STANDARD. (June 2018)

• Record Type: Journal Article
• Authors: Kollias, A.; Ntineri, A.; Kyriakoulis, K.; Stambolliu, E.; Stergiou, G.S.
• Is Part Of: Journal of hypertension. Volume 36(2018)Supplement 1
• Publication Date: 2018-06
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000539737.80493.48
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: To assess the blood pressure (BP) measurement accuracy of the iHealth oscillometric ambulatory BP monitor (iHealthlabs Europe SAS, Paris, France) in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060–2:2013 (ANSI/AAMI/ISO) standard. Design and method: The test device is a fully automated oscillometric ambulatory BP monitor attached on an upper-arm cuff (without tubes) and synchronizes data via Bluetooth with an app running on iPad. Adults were recruited to fulfil the age, gender, BP and cuff distribution criteria of the ANSI/AAMI/ISO standard using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22–34 and 30–42 cm. Results: A total of 100 subjects were recruited and 85 were included in the analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference systolic BP was −0.7 ± 6.0 mmHg and for diastolic 0.7 ± 4.8 mmHg. For validation criterion 2, the SD of the averaged systolic BP differences between the test device and reference method per subject was 4.72 and for diastolic 3.97 mmHg. Conclusions: The iHealth oscillometric ambulatory BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard in adults and can be recommended for clinical use.