Koudryavtcev Sergey A, Lazarev Vyacheslav M
Department of Military Medicine, Municipal Medical and Preventive Treatment Facility, 'Clinical Hospital No 12', Sormovsky District, Nizhny Novgorod, Russian Federation.
Med Devices (Auckl). 2011;4:193-6. doi: 10.2147/MDER.S25800. Epub 2011 Oct 26.
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.
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.
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.
The BPLab(®) 24-hour ambulatory blood pressure monitoring device may be recommended for extensive clinical use.
自动血压测量设备越来越多地用于血压自我检测和24小时血压监测。如今，24小时血压监测是动脉高血压治疗中的一项必要程序。本研究的目的是根据欧洲标准BS EN 1060-4:2004和英国高血压学会（BHS）方案验证BPLab（®）动态血压监测仪，并制定关于在临床实践中使用该设备的适用性的解决方案。
本研究招募了一组85名不同年龄和性别的患者，他们自愿同意参与测试，并接受了关于测量技术的详细指导。将合格操作人员使用BPLab（®）设备获得的血压测量结果与使用柯氏听诊法测量的血压值进行比较。数据由两名经验超过10年且完成了无创血压测量标准化培训课程的专家同时获取。根据BHS-93方案规定的标准分析收缩压和舒张压测量的差异（N = 510；每位专家255次）。
该设备符合欧洲标准BS EN 1060-4:2004的要求，根据BHS方案的标准，收缩压和舒张压均被评为“A”级。
BPLab（®）24小时动态血压监测设备可推荐广泛应用于临床。
