Operating Principles

The principles for the functioning of the device are based on a direct relationship between the volume changes of segments of the VoluSense Pediatrics vest and the signals generated by these segments via electromagnetic induction. This novel approach to tidal breathing assessment has been tested in a number of clinical studies.

VoluSense Pediatrics is based on proprietary technologies related to volumetric physiological measuring systems and methods, using electromagnetic induction techniques (EIP).

Device details and safety

Our products are developed, produced and marketed in accordance with applicable regulations and approval procedures.

The resulting respiratory measurements are derived from changes in electromagnetic inductance in a wrap-around vest worn by the subject. The vest is disposable and should be used for one patient only to avoid cross-infections. The vest is made from soft elastic and hypoallergenic material (cotton and Lycra) evaluated according to ISO10993 and provided in sizes appropriate for the premature neonatal patient population including the smallest babies of less than one kilogram in weight.

The vests contain thin conductive coils that are insulated. Thorax volumes and volume changes are measured and depicted on a touch screen. The measurements are stored digitally for later review and comparison.

A weak, homogeneous magnetic field is created across a horizontally positioned bed or incubator. Magnetic noise from surrounding systems is factored in by means of a brief calibration procedure before each measurement. The magnetic field is of the same order of magnitude as the Earth’s magnetic field. Radiation from the system is low, comparable to the level from a traditional television set at a few meters away. A weak alternating current and very low voltage is applied.

For more details and specifics for each VoluSense release and patient vest, please refer to the applicable user guide.