Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol

Background The Omron 705IT (HEM-759-E, Omron Corporation, Kyoto, Japan) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society and the Association for the Advancement of Medical Instrumentation SP10 validation criteria. Methods Study participants were recruited until a total of 85 were obtained that filled the blood pressure categories specified by the British Hypertension Society protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's & St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between mercury reference sphygmomanometers and the Omron 705IT (HEM-759-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with British Hypertension Society and Association for the Advancement of Medical Instrumentation criteria to determine the outcome of the study. Results The Omron 705IT (HEM-759-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the British Hypertension Society criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.60 (6-0) mmHg for systolic and -3.15 (6.6) mmHg for diastolic pressures, respectively. The device, therefore, also satisfies the Association for the Advancement of Medical Instrumentation SP10 standard, that requires differences of less than +/- 5 (8) mmHg. Conclusions The Omron 705IT (HEM-759-E) achieved an 'A/A' performance classification under the British Hypertension Society criteria and passes the Association for the Advancement of Medical Instrumentation requirements for the study population. It can be recommended for professional and home-use in an adult population.