Ventilator, adult

Intended purpose

The device is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The ventilator is intended to support pediatric patients (children and adolescents, weighing 20 Kg (44 lb) or greater), and adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. The ventilator is intended to be used only with various combinations of BMC-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.