Portable ventilator, electric

Intended purpose

The ventilator 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 weighing 20 kg (44 lb) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications.