Inova Labs Activox DUO2 User Manual
Operator’s Manual
Manufactured for & Distributed by
www.InovaLabs.com
Copyright © 2015 Inova Labs, Inc. All rights reserved.
No part of this document may be reproduced or
transmitted in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise,
without prior written permission from Inova Labs Inc.
Inova Labs Inc.
3500 Comsouth Drive
Suite 100
Austin, TX 78744 USA
Phone: 1.512.617.1700
Toll-Free: 1.800.220.0977
www.InovaLabs.com
0459
Represented in Europe by:
QNET BV
Hommerterweg 286
6436 AM Amstenrade
The Netherlands
TABLE OF CONTENTS
Introduction 2
Application/Indications For Use 2
Symbol Descriptions 3
Warnings 4
Contraindications 4
Adverse Events/Hazards 5
System Overview 6
Compatibility Interoperability 6
Standard Package Contents 7
User Controls 8
Part Names 10
Operating Instructions 12
Light Indicators/Alarms 15
Routine Maintenance 18
Specifications 20
Oxygen Concentration Over Altitude and Flow Rate 21
Accessories 21
Technical Support 22
Disposal 22
Service Life 22
Service Life Record 23
Warranty 25
EMC Information 29
Provider Instructions 32
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
SYMBOL DESCRIPTIONS
Symbol Description Symbol Description Symbol Description
Caution
No Smoking No Oil or Grease No Open Flame
Do Not Disassemble Keep Dry This Side Up
Fragile, Handle
with Care
Temperature Limit Humidity Limitation Radio Frequency
Gas Flow
U.S. Federal Law
Restricts This Device
to Sale By or On The
Order of A Physician
Type B Applied Part
Device that has no
conductive contact with
the patient
Consult Instructions
for Use
Compliant with
WEEE
Rechargeable
Battery
Catalogue Number Manufacturer
Serial Number Date of Manufacture
CE Marking
of Conformity
Representative
IPX0
Portable Oxygen
Concentrator
Connection
Class II Equipment
Not Protected Against
Water Ingress
Authorized
Representative in the
European Community
3
WARNINGS
1. U.S. Federal law restricts this device to sale by or on the order of a
physician.
2. It is the responsibility of the patient and/or provider to make
back-up arrangements for an alternative oxygen supply.
3. Availability of an alternate source of oxygen is required in case of
power outage or mechanical failure.
4. The device should be located as to avoid pollutants or flames.
5. Portable and mobile RF communications equipment can affect
medical devices. It is not recommended to operate the device near
or adjacent to other equipment other than the LifeChoice Activox
POC. If adjacent use is necessary, the Activox DUO2 Stationary
Concentrator should be observed to verify normal operation in the
configuration in which it will be used.
6. When storing or transporting the device, always keep it upright.
7. Inova Labs Inc. assumes no liability for persons choosing not to
adhere to manufacturer recommendations.
CONTRAINDICATIONS
1. The device is not intended to be life-supporting nor life-sustaining.
2. In certain circumstances, oxygen therapy can be hazardous. Please
seek medical advice before using this device.
3. The system is designed to provide a flow of high purity oxygen
up to 5 LPM continuous on the stationary base and up to 3 LPMeq
pulse on the POC. This system should only be used by patients
prescribed oxygen therapy within this range.
4. As the device will alarm through audio and visual indicators,
patients who are unable to communicate discomfort, hear, see and/
or understand the alarms may require additional monitoring.
4
ADVERSE EVENTS/HAZARDS
Failure to adhere to the statements below may impair performance of
the device and may void all warranties.
1. DO NOT use oil, grease or petroleum-based products on or near
the device.
2. DO NOT use power supplies or air filters other than those that came
with the system.
3. DO NOT allow smoking or open flames within 10 ft. (3 m) of the
device as the device produces enriched oxygen gas which
accelerates combustion.
4. DO NOT obstruct the air flow to the inlet and exhaust vents on
the oxygen concentrator. The device should be located in a well
ventilated area.
5. DO NOT submerge the device in liquid. The device should not be
exposed to water or precipitation as it may damage the electronic
components of the device and will void all warranties.
6. DO NOT operate or expose the device to temperatures and
humidity levels outside of the specified operational environment
conditions outlined in the Specifications section on pg. 20.
Excessive temperatures and humidity levels may damage the
device.
7. DO NOT plug the device into the same electrical outlet as major
appliances. Doing so may cause an electrical overload.
8. Humidifiers should not be used with pulse dose delivery
concentrators as they may affect the device’s performance in
triggering a pulse.
9. Use of certain humidifiers not specified for use with this oxygen
concentrator may impair performance.
10. DO NOT dismantle, open or shred secondary cells or batteries.
11. DO NOT expose cells or batteries to heat or fire and avoid storage in
direct sunlight.
NOTE: Refer to the LifeChoice Activox Portable Oxygen Concentrator
Operator’s Manual for additional Warnings, Contraindications and
Adverse Events/Hazards related to the POC.
5
SYSTEM OVERVIEW
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 POC.
It is important to keep the POC connected to the stationary base when
not in use. The POC offers additional control functions (mute) for the
stationary unit as well as monitors overall system operation (runtime)
and records service-related events (alarms). When connected to a
power source, the stationary base will charge both the internal and,
if purchased, external batteries for the POC.
COMPATIBILITY INTEROPERABILITY
Designed as a fully-integrated system, the stationary base will only
work with a compatible POC. In the event that the POC requires
service, the stationary base will operate independently.
Stationary base settings will not transfer to the POC when it is
disconnected for use. When disconnected from the stationary base,
the POC will power on at the last Pulse Setting used.
6
STANDARD PACKAGE CONTENTS
1
3
2
4
5
1
Activox DUO2 Stationary Base*
LifeChoice Activox POC*
2
3
AC Power Cord
(On back of unit)
Maintenance Tool
4
*Model identified on unit and packaging labels.
8
7
6
5
Replacement Air Filter
LifeChoice Activox External Battery
6
(Sold Separately)
7
External Battery Crate
8
Tool Holder
7
USER CONTROLS
Activox DUO2 Stationary Base Control Panel
Power
Switch
Reset
Button
Power
Indicator
External Battery
Charge Indicator
Alarm
Indicator
Flow Setting
Control Dial
Flow Setting
Meter
Power Switch: Turns the stationary base on or off.
Reset Button: If the internal circuit breaker has been tripped, the
Reset Button will extend, an audible alarm will sound continuously
for approximately 2 seconds, the unit will shut down and the POC will
function as though it were not connected to the stationary base. To
reset the internal circuit breaker, press the Reset Button.
Power Indicator: This LED will indicate if the stationary base is on
or off.
External Battery Charge Indicator: This LED will indicate if an
External Battery connected to the stationary base is charging. The LED
will flash if the External Battery is charging and will remain solid if it
is fully charged.
Alarm Indicator: This LED will indicate an alarm. Alarms may
consist of an audible and/or visual signal. Please reference the Alarm
Indicator diagram on pg. 16 to determine the cause of the alarm.
Flow Setting Control Dial: This dial is used to adjust the oxygen
flow within a range of 0 and 5 liters per minute (LPM).
Flow Setting Meter: This meter will indicate the oxygen flow
settings in LPM.
Audible Signals: An audible signal (beep) will indicate either a
change in operating status, or a condition that may need response
(alarm). Audio response will vary among users depending upon
hearing abilities.
CAUTION: Using unauthorized accessories may impair performance
8
and may void all warranties.
When a LifeChoice Activox POC and Activox DUO2 Stationary Base
are connected, the POC’s Control Panel will provide additional control
functions for the stationary base. For instructions on using the POC
separately, please refer to the LifeChoice Activox Portable Oxygen
Concentrator Operator’s Manual that came as a part of the system.
For a quick reference on the POC’s Control Panel, refer to the diagram
below.
Pulse Setting
Indicators
Power Indicator
LifeChoice Activox POC Control Panel
Activox Pro & Sport Control Panel
Alarm
Indicator
Power Button
Mute Button
Internal Battery
Charging Indicator
External Battery
Charging Indicator
Battery
Check
Button
Battery
Charge
Indicator
Hour Meter
(For use by trained
personnel only)
9
Loading...