Validation of the Andon KD-391 semiautomated blood pressure monitor in adults according to the International Protocol

Abstract

Accurate blood pressure measurement is important for both the patients and the health service in appropriate treatment and estimation of clinical risk. Few automated devices have been shown to be accurate when compared with mercury sphygmomanometer. This study presents the validation results of the Andon KD-391 semiautomated blood pressure monitor according to the International Protocol of the European Society of Hypertension (ESH) in an adult population. Sequential measurements of systolic and diastolic blood pressures were obtained in 33 participants who fulfilled the requirements of the International Protocol using the mercury sphygmomanometer (two observers) and the test device (one supervisor). According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). In phase 1, the Andon KD-391 device produced 29, 38 and 44 measurements for systolic blood pressure and 28, 39 and 43 for diastolic blood pressure falling within the zones 5, 10 and 15 mmHg, respectively. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -0.17+/-7.07 mmHg for systolic and -1.01+/-5.95 mmHg for diastolic blood pressure. According to the results of the validation study on the basis of the ESH International Protocol, the Andon KD-391 can be recommended for clinical use in an adult population.