Device Dossier
Anaesthesia system
Device Dossier for Anaesthesia system (Anaesthesia system, Class IIb, sponsor Draeger). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Anaesthesia system
Intended purpose
This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions: – Ventilation monitoring – Inspiratory O2 measurement – Device monitoring – Anesthetic gas receiving system The following options are additionally available: – Patient-gas measurement module for O2, CO2, N2O, and anesthetic gases – O2 insufflation Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system, such as the Bain, Mapleson, Kuhn, or Waters system, may be used at the external fresh-gas outlet.