Device Dossier

Heating unit, pad, water, control unit

Device Dossier for Heating unit, pad, water, control unit (Heating unit, pad, water, control unit, Class IIb, sponsor New Medical). ARTG record, intended…

Intended purpose

Cooling and heating device used to thermoregulate a patient's temperature. Used where a patient's core temperature needs to either be maintained at normothermia levels or be lowered to induce therapeutic hypothermia such as post cardiac arrest, neonatal hypoxia, traumatic brain injury. The device achieves this through working in an automated feedback way by circulating water through wraps or pads placed on the outside of the patient's skin surface. The device circulates water either in a heated or chilled form to control a patient's temperature through means of conduction.

TGA Public Summary