Validation of the Omron MX3 Plus oscillometric blood pressure monitoring device according to the European Society of Hypertension international protocol

Background Demand for devices that allow the self-assessment of blood pressure continues to rise. Few self-assessment devices, however, have been validated against recognised protocols. The aim of this study was to validate the Omron MX3 Plus (model HEM-742-E) oscillometric blood pressure measuring device in accordance with the international protocol of the European Society of Hypertension. This automated device is currently available to the public in the UK through high-street chemists and other outlets. Design The European Society of Hypertension's international protocol for validation of blood pressure measuring devices in adults divides validation into two phases. The first phase is performed on 15 individuals, five in each of three specific blood pressure categories. If the device passes the first phase then a further 18 patients are recruited, making a total of 33 individuals on which the final validation is based. All subjects are aged 30 years or above. Methods The automated device was connected in parallel to two reference mercury sphygmomanometers. Nine sequential same-arm measurements were taken from each subject by two trained observers, alternating between the mercury sphygmomanometers and the test device. Results The Omron MX3 Plus passed both phases of the ESH validation process. The mean (standard deviation) of the difference between the observer and the device measurements was - 1.15 (5.7) mmHg for systolic and - 1.61 (4.7) mmHg for diastolic pressures, respectively. Conclusions The Omron MX3 Plus can be recommended for home and professional use in an adult population. (c) 2005 Lippincott Williams & Wilkins.