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)

Abstract

Farahnaz Joukar,1– 3,* Sara Yeganeh,2,* Mohammadreza Naghipour,1 Soheil Hassanipour,3 Hossein-Ali Nikbakht,4 Fariborz Mansour-Ghanaei1– 3 1Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran; 2Caspian Digestive Disease Research Center, Guilan University of Medical Sciences, Rasht, Iran; 3GI Cancer Screening and Prevention Research Center, Guilan University of Medical Sciences, Rasht, Iran; 4Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran*These authors contributed equally to this workCorrespondence: Fariborz Mansour-Ghanaei Tel [phone]Fax [phone]Email [email protected]: 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.Keywords: validation, electronics, blood pressure monitor, automated devices, American Association for the Advancement of Medical Instrumentation

Keywords

• validation
• electronics
• blood pressure monitor
• automated devices
• american association for the advancement of medical instrumentation