Primary objective: To measure the repeatability and pressure pulse envelope of simulators used for testing oscillometric non-invasive blood pressure (NIBP) devices; to study the effect of different envelopes on NIBP devices, and to measure the difference between NIBP devices due to different oscillometric algorithms.
Methods: Three different models of NIBP simulator and 18 different patient monitors with NIBP function were studied. We developed a pressure measurement system (accuracy 0.048?mmHg) to measure the repeatability of simulators. The effect of changing the envelope was measured by using three simulators with one NIBP device. Differences between 18 NIBP devices were measured using one simulator at seven blood pressure settings.
Main outcomes and results: Simulators generate repeatable pressure pulse envelopes (< 0.2 mmHg) but the magnitude and shape depends on the model of simulator. Oscillometric NIBP devices are highly repeatable (< 2 mmHg) when presented with a repeatable pressure pulse envelope, but different devices employ different algorithms and give different results. For a simulated standard blood pressure setting of 120/80 mmHg, estimates of systolic pressure ranged from 112.6 to 126.6 mmHg (sd of 3.0 mmHg), and diastolic pressure ranged from 74.8 to 86.9 mmHg (sd of 3.5 mmHg).
Conclusions: Simulators and NIBP devices are sufficiently repeatable for clinical use, but further systematic clinical studies are required to better characterize the pressure pulse envelope for different patient groups.