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The Servo-air ventilator system is intended for respiratory support, monitoring and treatment of pediatric and adult patients to be used only by healthcare providers to be used only in professional healthcare facilities and for transport within these facilities

The Servo-air 4.0 Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The Servo-air 4.0 Ventilator System is based on the cleared predicate device Servo-U/n 2.1 Ventilator System (K180098), with some modifications. The ventilation modes in the Servo-air 4.0 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the Servo-air, and the cleared predicate device Servo-U/n 2.1. The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. Servo-air contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). The Servo-air 4.0 Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.