Device Dossier

Horizon Brammi - Heating unit, pad, water, control unit

Device Dossier for Horizon Brammi - Heating unit, pad, water, control unit (Heating unit, pad, water, control unit, Class IIb, sponsor Innervate). ARTG…

Intended purpose

The Horizon Brammi Infant Thermoregulation System delivers thermoregulation by monitoring and controlling the core temperature of infants, which can be used to maintain normothermia. It is suitable for use in babies who are affected by Hypoxic Ischaemic Encephalopathy (HIE) where the clinician requires the baby to receive moderate total body hypothermia in a hospital environment i.e. NICU, PICU. The system also has a non-servo mode. The Brammi System includes disposable mattresses, disposable rectal probes, and a reusable skin probe.

TGA Public Summary