Device Dossier

Inflator, tracheal tube cuff

Device Dossier for Inflator, tracheal tube cuff (Inflator, tracheal tube cuff, Class IIa, sponsor Draeger). ARTG record, intended purpose, GMDN category…

Intended purpose

The CuffGuard is an endotracheal tube or tracheostomy tube cuff controller designed to continuously monitor and maintain user-defined cuff pressure in the ICU, OR and for intra-hospital transport. The CuffGuard is used for patients who require mechanical ventilation and who are intubated with endotracheal tube or tracheostomy tube including cuff. The CuffGuard has a pressure sensor and software that can monitor and automatically adjust the cuff pressure. The CuffGuard has no applied parts or parts that may come into contact with the patient. Note that the CuffGuard is used in combination with a connection tube and an endotracheal tube or a tracheostomy tube. The endotracheal tube and the tracheostomy tube are not supplied by IDMED. For the applied parts of these devices please refer to the documentation of their manufacturer.

TGA Public Summary