Device Dossier

Sleep disorder interpretive software, professional-use

Device Dossier for Sleep disorder interpretive software, professional-use (Sleep disorder interpretive software, professional-use, Class IIa, sponsor…

Intended purpose

prismaTS is a clinical software application intended to import, store, display and analyse therapy data recorded by compatible Löwenstein Medical positive airway pressure (PAP) therapy devices. The software enables healthcare professionals to review therapy information and generate reports to support the monitoring and evaluation of respiratory therapy. The software does not control or modify therapy delivery and is intended to be used by trained healthcare professionals in clinical or sleep laboratory environments.

TGA Public Summary