Aerogen Pro-X - Introduction; Indications for Use

Aerogen
®
2
Introduction
The Aerogen
®
Solo System is an iteration of the Aerogen
®
Pro System.
The indications for use of the Aerogen
®
Pro System are given below. The
Aerogen
®
Solo System consists of the Aerogen
®
Solo nebuliser and the
Aerogen
®
Pro-X Controller. It is intended for hospital use only to nebulise
physician-prescribed medications for inhalation which are approved for
use with a general purpose nebuliser. The Aerogen
®
Solo nebuliser 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
nebulisation of neonate, paediatric and adult patients as described in this
manual.
Indications for Use
The Aerogen Pro System is a portable medical device for multiple patient
use that is intended to aerosolise physician-prescribed solutions for
inhalation to patients on and off ventilation or other positive pressure
breathing assistance. The Aerogen Pro System is suitable for use in adult,
paediatric and neonate patients as described in the Instruction Manual.