Inova Labs Activox DUO2 - Manual (Page 4)

INTRODUCTION
The Activox DUO2 ® System is a fully-integrated oxygen concentrator
system for stationary and portable use. It consists of the Activox
DUO2 Stationary Base and the LifeChoice
® Activox ® Portable
Oxygen Concentrator (POC).
This operator’s manual will provide familiarity with the stationary
base and its accessories when used in conjunction with the POC.
It is important that all of the enclosed information, as well as that
pertaining to the LifeChoice Activox Portable Oxygen Concentrator
Operator’s Manual is read in its entirety.
The Activox DUO2 Stationary Base is an externally powered,
Class II, Type B device. The essential function of the device is to provide
oxygen at a volume that remains within tolerance - the tolerance was defined
based on technical judgment from within the manufacturer’s expertise in
this specific medical application. In addition, the device’s ability to detect
certain error conditions such as low oxygen concentration and create
an alarm is also considered a part of its essential function.
APPLICATION/INDICATIONS FOR USE
This manual applies to the Activox DUO2 Stationary Base Model
130-001.
INDICATIONS FOR USE: The Activox DUO2 Oxygen Concentrator
is used on a prescriptive basis by adult patients who are diagnosed
as requiring supplemental oxygen. The oxygen concentrator will
provide supplemental, high concentration oxygen to these patients. It is
not life-supporting nor life-sustaining. It may be used continuously in a
home or institutional/hospital setting.
2