Validation of the Rossmax S150 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

Abstract

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor Rossmax S150 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (16 women, mean age of 54 years) using a mercury sphygmomanometer (two observers) and the Rossmax S150 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. Data analysis was carried out using the ESHIP analyzer. The Rossmax S150 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 70/99, 90/99, and 97/99, respectively, for systolic blood pressure, and 84/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-six and 29 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥ 24). Three and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers comparisons greater than 5 mmHg. The Rossmax wrist blood pressure monitor S150 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.