Validation of the SCIAN LD-735 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Objective: This study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor SCIAN LD-735 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010.

Methods: Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese participants (10 women, mean age 44.8 years) using a mercury sphygmomanometer (two observers) and the SCIAN LD-735 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.

Results: The SCIAN LD-735 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 86/99, 97/99, and 98/99, respectively, for systolic blood pressure and 85/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. In total, 30 and 33 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure.

Conclusion: The SCIAN wrist blood pressure monitor LD-735 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.