Characterization of a pressure measuring system for the evaluation of medical devices.

The purpose of this study is to evaluate the possible use of four "FSA" thin and flexible resistive pressure mapping systems, designed by Vista Medical (Winnipeg, Manitoba, Canada), for the measurement of interface pressure exerted by lumbar belts onto the trunk. These sensors were originally designed for the measurement of low pressure applied by medical devices on the skin. Two types of tests were performed: standard metrology tests such as linearity, hysteresis, repeatability, reproducibility and drift, and specific tests for this application such as curvature, surface condition and mapping system superposition. The linear regression coefficient is between 0.86 and 0.98; hysteresis is between 6.29% and 9.41%. Measurements are repeatable. The location, time and operator, measurement surface condition and mapping system superposition have a statistically significant influence on the results. A stable measure is verified over the period defined in the calibration procedure, but unacceptable drift is observed afterward. The measurement stays suitable on a curved surface for an applied pressure above 50 mmHg. To conclude, the sensor has acceptable linearity, hysteresis and repeatability. Calibration must be adapted to avoid drift. Moreover, when comparing different measurements with this sensor, the location, the time, the operator and the measurement surface condition should not change; the mapping system must not be superimposed.