Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS).

BACKGROUND

Blood pressure (BP) measurement accuracy is critical to the diagnosis and management of hypertension. The aim of the present study was to validate the Omron HBP-1100-E professional blood pressure measuring device in accordance with the American Association for the Advancement of Medical Instrumentation in Iranian adults.

MATERIALS AND

METHODS

Simultaneous blood pressure auscultator measurements were obtained by two observers using mercury sphygmomanometers as a reference, sequentially with a measurement by using the Omron HBP-1100-E device. Absolute device-reference blood pressure differences were categorized into three error categories (within 5, 10, and 15 mmHg), and mean device-reference blood pressure difference (standard deviation) was calculated and evaluated using the American Association for the Advancement of Medical Instrumentation criteria.

RESULTS

A total of 85 participants (250 paired readings) were enrolled to the study. 26.8%, 55.6%, and 79.6% of the device-reference blood pressure differences agreed to within 5, 10 and 15 mmHg, respectively, for systolic blood pressure, and 39.6%, 69.2%, and 81.6% of measurements for diastolic blood pressure, respectively, and failed to pass the protocol criteria. The mean device-reference blood pressure difference was 8.0 ± 13.1 mmHg for systolic BP and 2.2 ± 11.3 mmHg for diastolic BP, and was >5.0 ± 8.0 mmHg (required criteria).

CONCLUSION

Omron HBP-1100-E professional blood pressure monitor is not desirable for measuring the BP for Iranian adults as it overestimates blood pressure in this population.