Development of a simulator for the validation of noninvasive blood pressure-monitoring devices

This research aimed to develop a simulator capable of oscillometric pressure pulses recorded from the participants for the validation of oscillometric noninvasive blood pressure (NIBP) devices. The simulator generates the pressure pulses to the cuff connected to NIBP devices depending on the oscillometric waveforms obtained from the participants. Device readings were compared with auscultatory references (systolic and diastolic blood pressures) of the participants. A total of 94 oscillometric waveforms from participants were used in the simulator for the validation of two automated NIBP devices (Omron HEM-7221 and UA-787Plus). For Omron HEM-7221, the differences between device readings and auscultation references for systolic and diastolic blood pressures were 2.82 +/- 7.27 and -4.74 +/- 6.73 mmHg, respectively. UA-787Plus showed differences of 3.26 +/- 5.69 and -3.53 +/- 6.61 mmHg, respectively. Although the number of individual measurements did not fulfill the ISO 81060-2 requirement for clinical validation, criterion 1, where the average of the difference and SD should be lower than +/- 5 and -8 mmHg, was fulfilled. Although the simulator still needs extensive comparative studies to be verified, it could be a potential candidate for a simple and robust tool for the validation and quality control of NIBP devices. Copyright (C) 2016 Wolters Kluwer Health, Inc. All rights reserved.