Validation of the BPLab® 24-hour blood pressure monitoring system according to the European standard BS EN 1060-4:2004 and British Hypertension Society protocol

Abstract

Sergey A Koudryavtcev, Vyacheslav M LazarevDepartment of Military Medicine, Municipal Medical and Preventive Treatment Facility, ‘Clinical Hospital No 12’, Sormovsky District, Nizhny Novgorod, Russian FederationIntroduction: Automatic blood pressure (BP) measuring devices are more and more often used in BP self-checks and in 24-hour BP monitoring. Nowadays, 24-hour BP monitoring is a necessary procedure in arterial hypertension treatment. The aim of this study was to validate the BPLab® ambulatory blood pressure monitor according to the European standard BS EN 1060-4:2004 and the British Hypertension Society (BHS) protocol, as well as to work out solutions regarding the suitability of using this device in clinical practice.Methods: A group of 85 patients of both sexes and different ages, who voluntarily agreed to take part in the tests and were given detailed instructions on the measurement technique were recruited for this study. The results of the BP measurement obtained by a qualified operator using the BPLab® device were compared with the BP values measured using the Korotkov auscultatory method. Data were obtained simultaneously by two experts with experience of over 10 years and had completed a noninvasive BP measurement standardization training course. Discrepancies in the systolic and diastolic BP measurements (N = 510; 255 for each expert) were analyzed according to the criteria specified in the BHS-93 protocol.Results: The device passed the requirements of the European Standard BS EN 1060-4:2004 and was graded ‘A’ according to the criteria of the BHS protocol for both systolic BP and diastolic BP.Conclusion: The BPLab® 24-hour ambulatory blood pressure monitoring device may be recommended for extensive clinical use.Keywords: 24-hour blood pressure monitoring, device, validation, BPLab®