Compass Health RESVENT IBREEZE APAP WITH

This device has been authorized by the FDA for Emergency Use (EUA) during the Coronavirus Disease (COVID-19) pandemic.  The FDA definition of the device is a Continuous Ventilator for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.  The Intended Use of the iBreeze PAP system is to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30kg (66 lbs) for use in the home, hospital, or institutional environment.

For more information on the EUA, visit

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas#ventilators

For facts of the known and unknown risks and benefits of the emergency use, visit

 https://www.fda.gov/media/136424/downloadiBreeze Software Update Instructions
iMatrix User Quick Manual
User Guide (PDF)
ResAssist 2.0 Manual
Software Update-for units with version (SVN#) 20033, 20265, 20456, 20705, 20849 or 21149, please use file V01.11.01_21385_ESP32_HR01_HR01
Software Update- for units with version (SVN#) 20518, 20698, 20848, 20894, 21148, 21178 or 21957, please use file V01.12.01_21384_ESP32_HR01

Shipping Weight: 66.0 lbs