Aeroneb Solo System - Introduction; Indications for Use

Aeroneb
®
Solo System Instruction Manual 1
Introduction
The Aeroneb
®
Solo System is an iteration of the Aeroneb
®
Professional Nebulizer System. The indications for use
of the Aeroneb
®
Professional Nebulizer System are given
below. The Aeroneb
®
Solo System, which consists of the
Aeroneb
®
Solo nebulizer and the Aeroneb
®
Pro-X controller,
is a nebulizer system designed for use with mechanically
ventilated patients to aerosolize physician-prescribed
medications for inhalation which are approved for use with a
general purpose nebulizer. The Aeroneb
®
Solo nebulizer is for
single patient use only and the Aeroneb
®
Pro-X controller is
for re-use.
The Aeroneb
®
Solo System is suitable for use with neonate,
pediatric and adult patients as described in this manual. It is
for intermittent and continuous nebulization that incorporates
Aerogen’s OnQ™ Aerosol Generator.
The Aeroneb
®
Solo nebulizer is designed to operate in-line
with standard ventilator circuits and mechanical ventilators.
It operates without changing patient ventilator parameters and
can be relled without interrupting ventilation.
The Aeroneb
®
Pro-X control module operates from the AC/DC
adapter and can be operated on its internal rechargeable
battery for up to 45 minutes when fully charged. The product
operates without compressed gas, making it suitable for
portable applications.
Indications for Use:
The Aeroneb
®
Professional Nebulizer System is a portable
medical device for multiple patient use that is intended to
aerosolize physician-prescribed solutions for inhalation
to patients on and off ventilation or other positive pressure
breathing assistance. The Aeroneb
®
Professional Nebulizer
System is suitable for use in adult, pediatric and neonate
patients as described in the Instruction Manual.