Validation of the Andon KD-575 automated blood pressure monitor according to the European society of hypertension international protocol in adults.

OBJECTIVE

Blood pressure measuring devices should be subjected to an independent evaluation of accuracy before clinical use. The results of the validation of the Andon KD-575 automated blood pressure monitor according to the European Society of Hypertension International Protocol in adults are presented in this paper.

METHODS

Sequential same-arm measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). According to the validation protocol, 99 pairs 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).

RESULTS

In phase 1, the Andon KD-575 device produced 26, 38 and 43 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure and 35, 44 and 45 mmHg, respectively, for diastolic blood pressure. However, in phase 2, the test device failed to meet the criteria for systolic blood pressure but comfortably passed all of the criteria for diastolic blood pressure with a mean (standard deviation) device-observer difference of 2.00+/-7.12 mmHg for systolic and 1.47+/-4.71 mmHg for diastolic blood pressure.

CONCLUSION

The Andon KD-575 automated blood pressure monitor cannot be recommended for clinical use in an adult population because it records systolic blood pressure inaccurately.