In vitro protocol for validating interface pressure sensors for therapeutic compression garments: Importance of sphygmomanometer placement and initial cuff diameter

An optimal protocol is needed to validate the performance of future interface pressure sensors for compression garments when using a sphygmomanometer. PicoPress® was used on a rigid plastic cylinder (r=4 cm). An FDA-cleared aneroid sphygmomanometer was used to apply pressures from 10-60 mmHg with a diameter of 8 cm or 12 cm placed either beneath the sphygmomanometer’s airbag or fabric cuff. A two-tail t-test was performed (P<0.05 for significance) for all applied pressures. PicoPress® outputs vary with sensor placement (airbag vs fabric cuff) and the initial cuff diameter. Sensor placement overlying the sphygmomanometer’s fabric cuff compared to the airbag led to significantly higher pressures (37%-135%) depending on the cuff diameter size. These differences were nearly all statistically significant (P<0.05). Validation of new interface pressure sensors deploying a sphygmomanometer for calibration should specify the location of sensor placement location and initial diameter with a preference for placement under the airbag.