Aerogen Solo - Introduction; Indications for Use

Aerogen
®
2
Introduction
The Aerogen
®
Solo System is an iteration of the Aerogen
®
Pro Nebulizer
System. The indications for use of the Aerogen
®
Solo Nebulizer System
are given below. The Aerogen
®
Solo System consists of the Aerogen
®
Solo
nebulizer and the Aerogen
®
Pro-X Controller. It is intended for hospital use
only to nebulize physician-prescribed medications for inhalation which are
approved for use with a general purpose nebulizer. The Aerogen
®
Solo
nebulizer is for single patient use only and the Aerogen
®
Pro-X Controller
is for re-use.
The Aerogen Solo System is suitable for intermittent and continuous
nebulization of pediatric (29 days or older) and adult patients as described
in this manual.
Indications for Use
The Aerogen Solo Nebulizer System is a portable medical device for single
patient use that is intended to aerosolize physician-prescribed solutions
for inhalation to patients on and off ventilation or other positive pressure
breathing assistance.