Device Dossier
Ventilator, adult
Device Dossier for Ventilator, adult (Ventilator, adult, Class IIb, sponsor Lowenstein Medical). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Ventilator, adult
Intended purpose
The Elisa 600 and 800 VIT is designed for adult, paediatric, and neonatal patients requiring ventilation support. The range of application covers invasive and noninvasive ventilation by mask or helmet as well as nasal respiratory therapy (Highflow 02 therapy, nasal CPAP and nasal Bilevel). There are no known contraindications. It is the user's responsibility to select appropriate settings in consideration of the clinical situation of the ventilated patient, periodically review these settings and adapt them when necessary. When combined with an application system for volatile anaesthetic agents, the device can also be used as an anaesthesia workstation.