Device Description
The EMCOOLSpad is a single use surface (skin) cooling device, which is adherent to the patient´s skin and so highly adjustable during the cooling procedure. An EMCOOLSpad consists of multiple cooling-cells made of thermoplastic poly-urethane, filled with high thermal conductivity material, stored frozen at 0 to -10°C.
Intended Use of the Device
The EMCOOLSpad is a temperature reduction system for adult patients only where clinically indicated, e.g. in hyperthermic patients.
User and Patient Interface
The patient's core temperature is regulated within in a certain temperature range by manually removing (= warming) or applying (=cooling) the EMCOOLSpads.
Device Interface
A commercially available third-party temperature probe connected to a commercially available third-party monitor senses the patient's core temperature.
510(k) pending, currently not available for sales in the US