Aerogen USB Controller - Indications for Use; Introduction

40
Aerogen
®
Introduction
The Aerogen
®
USB Controller System is:
• A portable medical device that is intended to aerosolize physician-
prescribed medications for inhalation.
• The Aerogen
®
USB Controller should only be operated from mains
using the Aerogen USB Controller AC/DC Adapter.
• An alternative to the existing Aerogen
®
Pro and Aerogen
®
Pro-X
Controllers.
Indications for Use
The Aerogen
®
USB Controller System includes the Aerogen
®
Pro and
Aerogen
®
Solo Nebulizers, which are intended to aerosolize physician-
prescribed medications for inhalation to patients on vent only in the
homecare environment.
The Aerogen
®
Pro Nebulizer is intended for multiple patient use in
hospital environment and single patient use in home environment.
Aerogen
®
Solo Nebulizer is for single patient use. Both nebulizers are for
pediatric (29 days or older) and adult patients.
Note: The Aerogen Pro is not intended as a multiple patient use device in
Home Use.