Inova Labs Inc. Duo2 Operator's Manual

Manufactured for & Distributed by

3500 Comsouth Drive, Suite 100, Austin, Texas 78744 USA
Corporate Office 1.512.617.1700 | www.InovaLabs.com

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© 2015 Inova Labs Inc. All rights reserved. 13M-001 Rev H April 2015

Manufactured for & Distributed by

www.InovaLabs.com

Operator’s Manual

Inova Labs Inc.
3500 Comsouth Drive
Suite 100
Austin, TX 78744 USA
Phone: [phone]
Toll-Free: 1.800.220.0977
www.InovaLabs.com

0459

Represented in Europe by:
QNET BV
Hommerterweg 286
6436 AM Amstenrade
The Netherlands

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.

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

3

SYMBOL DESCRIPTIONS

Symbol Description Symbol Description Symbol Description

Caution

Consult Instructions

for Use

Portable Oxygen

Concentrator

Connection

No Smoking No Oil or Grease No Open Flame

Do Not Disassemble Keep Dry This Side Up

Fragile, Handle

with Care

Compliant with

WEEE

Class II Equipment

Temperature Limit Humidity Limitation Radio Frequency

Gas Flow

Rechargeable

Battery

IPX0

Not Protected Against

Water Ingress

U.S. Federal Law

Restricts This Device

to Sale By or On The

Order of A Physician

Catalogue Number Manufacturer

Serial Number Date of Manufacture

Type B Applied Part

Device that has no

conductive contact with

the patient

CE Marking

of Conformity

Representative

Authorized

Representative in the

European Community

4

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.

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 4 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.

CONTRAINDICATIONS

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

*Model identified on unit and packaging labels.

7

1

3

2

6

7

4

5

Activox DUO2 Stationary Base*

1

2

3

4

LifeChoice Activox POC*

(Standard Package)

AC Power Cord

(On back of unit)

Maintenance Tool

Replacement Air Filter

LifeChoice Activox External Battery

(Sold Separately)

External Battery Crate

5

6

7

8

Tool Holder

8

Activox DUO2 Stationary Base Control Panel

USER CONTROLS

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
and may void all warranties.

8

Flow Setting
Control Dial

Flow Setting
Meter

Power

Indicator

Reset

Button

External Battery
Charge Indicator

Alarm

Indicator

Power
Switch

9

LifeChoice Activox POC Control Panel

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.

Activox Pro & Sport Control Panel

Pulse Setting

Indicators

Mute Button

Battery
Charge
Indicator

Battery
Check
Button

Hour Meter

(For use by trained

personnel only)

Power Indicator

Power Button

Alarm
Indicator

Internal Battery

Charging Indicator

External Battery

Charging Indicator

Activox 4L Control Panel

Power Indicator

Power Button

Alarm Indicator

Navigation Controls

Mute Button

Display Screen

PART NAMES

10

POC Connection Cable: The Connection Cable plugs into the port on
the left side of the POC.

Lifting Handles: The handles are used when manually lifting the
stationary base.

Locking Front Wheels: The wheels swivel to enhance mobility during
relocation and lock to prevent unwanted movement when stationary.

Retractable Handle: The handle raises to enable the stationary base
to be moved easily.

LifeChoice Activox POC Cradle: The cradle holds the POC while it is
connected to the stationary base.

Cannula Nozzle Fitting: The nasal cannula connects to the metal
oxygen output nozzle on the front of the stationary base. Always
connect the cannula to this nozzle as it serves as a safety mechanism in
case of fire.

POC Connection

Cable

Lifting Handles

(on both sides)

Locking Front

Wheels

LifeChoice
Activox POC
Cradle

Cannula Nozzle
Fitting

Retractable Handle

11

PART NAMES

continued

Air Filter

Access Door

Fan Inlet Vent

Rear Wheels

External Battery
Charging Port

External Battery
Crate

AC Power Cord
Strap

AC Power Cord

Fan Outlet Vent (bottom)

Air Filter Access Door: The door is used to access the Air Filter for

replacement.

Fan Inlet Vent: Cooling air is drawn in through this opening.
(See Routine Maintenance section for cleaning instructions.)

Rear Wheels: The wheels support the entire weight of the stationary
base when it is tilted and rolled.

External Battery Charging Port: The port charges the POC’s External
Battery.

External Battery Crate: The crate stores the External Battery while
it is being charged.

AC Power Cord Strap: The strap secures the AC Power Cord when not
in use.

AC Power Cord: The cord is a NEMA 1-15P cord for a standard US non­grounded AC power plug.

Fan Outlet Vent: Processed air is exhausted through this opening.

OPERATING INSTRUCTIONS

The Activox DUO2 Stationary Base is designed to be used with a
compatible 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 for the stationary unit, as well as monitors
overall system operation and records service-related incidents.
When connected to a power source, the stationary base will charge
both the internal and, if purchased, external batteries for the POC.

For specific instructions on how to operate the LifeChoice Activox
POC separately, please refer to the LifeChoice Activox Portable
Oxygen Concentrator Operator’s Manual.

SETTING UP YOUR SYSTEM:

12

1. Plug the stationary base into the
nearest wall outlet.

2. Connect the nasal cannula to the
Cannula Nozzle Fitting.

3. Place the POC in the cradle located on
top of the stationary base and secure it
into place using the straps.

OPERATING
INSTRUCTIONS

continued

13

3. Plug the POC Connection Cable into
the port on the left side of the POC. If
you are using a Activox 4L POC, the
screen will display “Connected to
Activox DUO2”. If you are using an
Activox Pro or Sport POC, all three
pulse setting LEDs will illuminate.

NOTE: Ensure that the POC has at
least a partial internal battery charge
before connecting it to stationary base
that is powered on.

4. If an External Battery was purchased:

A. To attach the External Battery

Crate: (1) Insert the mounting
tabs on the External Battery Crate
into the holes on the backside of the
stationary base and (2) Slide the
External Battery Crate down until it
locks into place.

B. Place the External Battery in the

External Battery Crate.

C. Connect the External Battery to

the External Battery Port located
above the External Battery Crate.
The flat end of the cable should
be facing up. Verify the Battery
Charge LED on the front of the
unit is flashing.* It should take
approximately eight hours to fully
charge the External Battery.

CAUTION: Only use external batteries approved by Inova Labs.

*

NOTE: The External Battery will begin charging after the Internal Battery

in the POC has reached a 100% charge. The External Battery will also
charge when the POC is not connected to the DUO2.

1

2

14

OPERATING

INSTRUCTIONS

continued

CAUTION: (1) Use the stationary base only at the LPM setting and for
the length of time prescribed by your physician. (2) Maintain at least
1 ft. (30 cm) between the wall and the unit. (3) Do not set the indicator
ball above the red line.

1. Flip the Power Switch to the “On”
position. A one second audible
beep will sound, the Power LED will
illuminate green and the system will
begin running. It takes approximately
two minutes to reach full oxygen
concentration.

2. Use the Flow Setting Control Dial to
set the oxygen flow to the prescribed
LPM setting.

NOTE: If a 5 LPM setting is utilized,
adjust the dial so that the flow
indicator ball does not rise above the
“5” mark as it may cause the device
to alarm.

3. Position the nasal cannula or
breathing accessory onto your face
securely and begin breathing.

OPERATING YOUR SYSTEM:

15

LIGHT INDICATORS/ALARMS

NORMAL OPERATION INDICATORS

Normal

Operation

Light Indication Audible

Alarm

Action

Stationary

base is
plugged into a
power source.

All LEDs flash briefly.

Brief

audible

tone from

unit.

None. Stationary

base is functioning

normally.

Stationary

base is in the

“On” position

and running.

Power LED illuminates solid green.

Battery Charge LED may illuminate or

flash if External Battery is connected.

None

Allow for a warm-up

period of approximately

2 minutes before using.

Stationary

base is

charging

the External

Battery.

The Battery Charge LED

flashes green faster as the External

Battery approaches a full charge.

None

None. Stationary

base is functioning

normally.

Stationary

base has fully

charged the

External

Battery.

The Battery Charge LED illuminates

solid green.

None

None. Stationary

concentrator

is functioning normally.

When POC is

first connected

to the

stationary

base.

Pro & Sport Models: All LEDs flash

once and Pulse Setting LEDs remain

illuminated. The INT LED will

illuminate until the internal battery is

fully charged.

4L Model: “Connected to Activox

DUO2”, the INT Battery Bar and the

External Power Symbol will display

on the screen. “Charging Internal”

will display until the Internal Battery

is fully charged.

Brief

audible

tone from

POC.

None. POC is properly

connected to the stationary

base.

Connected to Activox DUO2

Charging Internal

16

ALARM/LIGHT

INDICATORS

continued

ALARM INDICATORS

NORMAL OPERATION INDICATORS

Problem Light Indication Audible

Alarm

Action

No oxygen
flow or low

oxygen
detected by
the system.*

Power LED is illuminated and

the Alarm LED illuminates

solid red.

5 second

audible

tone every

minute.

Remove the nasal cannula

hose from the Cannula Nozzle

Fitting:

• If the alarm stops, you
have a “no oxygen flow”

alarm. Check the hose for

kinks or blockage. If found,

remove the kink or blockage

and re-connect the cannula

hose. If the alarm does not

return, continue use. If no
kink or blockage is found,

switch to the POC or another

source of oxygen and contact

your equipment provider.

• If the alarm remains, you

have a “low oxygen purity”

alarm. Turn the system off.

Switch to the POC or another

source of oxygen and contact

your equipment provider.

High

pressure

detected by

the system.

The red Alarm LED light
flashes on and off every

.5 seconds

Audible

tone

alternating

on for

2 seconds

and then

off for 2

seconds.

Turn the system off.

Switch to the POC or another

source of oxygen and contact

your equipment provider.

Normal

Operation

Light Indication Audible

Alarm

Action

Stationary
base is on and

connected to

the POC.

*

Power

LED illuminates solid green. Battery

Charge LED may illuminate or flash if

External Battery is connected.

None

None. The stationary base

is properly connected to

the POC.

*If the POC being connected to the stationary base has a completely depleted internal battery, the LEDs
on the stationary base will briefly turn off and an approximate two second audible tone will sound before
the normal operation indicators initiate.

Problem Light Indication Audible

Alarm

Action

Low

pressure

detected by

the system.

The red Alarm LED light

flashes on and off every .5

seconds

Audible

tone

alternating

on for

2 seconds

and then

off for 5

seconds.

Turn the system off.

Switch to the POC or another

source of oxygen and contact

your equipment provider.

High

Temperature

detected by

the system.

The red Alarm LED light

flashes on and off every .5

seconds

Audible

tone

alternating

on for

2 seconds

and then

off for 1
second.

Turn the system off.
Switch to the POC or another
source of oxygen. Check the

air vents. If there is blockage,

remove it and restart the

system after 15 minutes. If

there is no blockage, contact

your equipment provider.

AC power
interruption
detected by

the unit.

All LEDs off.

Approx.

2 second

audible

tone.

Switch to the POC or another
source of oxygen. Check the

power supply. If there is a

power supply issue, solve

as appropriate. If there is no

power supply issue, contact

your equipment provider.

Circuit

Breaker

tripped

All LEDs off.

Approx.

2 second

audible

tone.

Reset the internal circuit

breaker, by pressing the

Reset Button. If there is a

power supply issue, solve

as appropriate. If there is no

power supply issue, contact

your equipment provider.

17

ALARM/LIGHT
INDICATORS

continued

ALARM INDICATORS

MUTE BUTTON

When the POC is connected to the Stationary Base, the POC mute button can be
pressed to mute the audible tones from the Stationary Base.

*

NOTE: The unit will not alarm for low oxygen purity during the first five minutes of

Activox DUO2 operation to allow the unit to reach full oxygen production.

ROUTINE MAINTENANCE

The Activox DUO2 System was designed to minimize the amount of
routine maintenance that is required. The device includes no end­user repairable parts. Aside from the preventative maintenance
outlined below, all other required maintenance must be performed
by qualified personnel.

INSTALLING A NEW AIR FILTER:

It is recommended that the Air Filter be changed yearly. However,
if the Activox DUO2 Stationary Base is used in dusty environments,
filter replacement may be required more frequently. The system
comes equipped with one factory-installed air filter and one
replacement filter. Contact your equipment provider for additional
replacement filters.

18

1. Flip the Power Switch to the “Off”
position.

2. Unplug the stationary base from the
electrical outlet.

3. Remove the Air Filter Access Door.

4. Remove the used Air Filter.

A. Wedge the pointed end of the

Maintenance Tool under the Air
Filter.

B. Raise the Air Filter up until it

dislodges from its position.

C. Pull the Air Filter out of its housing.

19

ROUTINE
MAINTENANCE

continued

5. Replace with a new Air Filter.

A. Put the new Air Filter into its

housing.

B. Firmly push down on the Air Filter

until it pops securely into place.

6. Replace the Air Filter Access Door.

7. Plug the stationary base into an
electrical outlet.

8. Flip the Power Switch to the “On”
position.

B

A

CAUTION: DO NOT operate the stationary base without an approved
Inova Labs Air Filter installed. Operating the system without a filter
may cause damage.

FAN INLET VENT CLEANING:

There is one fan inlet vent located on the back of the stationary base,
just above the serial number label. It is recommended that you
check this vent frequently to ensure there is no buildup of lint, hair
or other materials that could obstruct the flow of air into the vent.
Should the vent become obstructed, remove the material buildup
using a soft brush or a dry cloth. Never use alcohol, solvents or
petroleum distillates for cleaning any part of the stationary unit.

NASAL CANNULA INSPECTION:

At least once a week, visually inspect the nasal cannula. Make sure
there are no kinks or obstructions in the nasal cannula. Replace as
needed. DO NOT use a nasal cannula greater than 57 ft. (17 m).

20

SPECIFICATIONS

These specifications apply to the Activox DUO2 Stationary Base. For
LifeChoice Activox POC specifications, refer to the LifeChoice Activox
Portable Oxygen Concentrator Operator’s Manual.

Device Electrical Classification: Class II, Type B

Stationary Base Weight: 37.5 lbs. (17 kg)

Dimensions: 14.2” w x 24.8” h x 14.6” d (36 cm w x 63 cm h x 37cm d)

Mode of Operation: Continuous

Flow Setting Control*: 0 to 5 LPM

Oxygen Concentration†: 93% ± 3% (0-5 LPM)

Oxygen Concentration Sensor Alarm: 82% or less

Maximum Outlet Pressure: 8 psi (55 kPa)

Average Sound Level: 45 dB(A) at 10 ft. (3 m)

Power Supply: 230 (±10%) VAC, 50 Hz (Model 130-002)

Nasal Cannula: 57 ft. (17.3 m) maximum

Environmental Conditions for Use, Storage and Transport

Operational Temperature Range: 50°F to 95°F (10°C to 35°C)

Operational Humidity Range: Up to 95%, Non-condensing

Storage Temperature Range: 32°F to 140°F (0°C to 60°C)

Storage Humidity Range: Up to 95%, Non-condensing

Oxygen Sensor: 41°F to 113°F (5°C to 45°C), 0 to 13,123 ft. (0 to 4000 m),

101kPA to 60kPA

TECHNICAL DESCRIPTION

The Activox DUO2 System is a transportable*, prescription-use only
device that provides a high concentration of supplemental oxygen
to the end user. The system’s operation is based on the principle of
pressure swing adsorption (PSA). During PSA, nitrogen is removed
from incoming ambient air by bonding onto a molecular sieve material.
The remaining atmospheric gases, primarily concentrated oxygen, is
supplied to the end user through a nasal cannula. The system produces
a reliable and consistent source of physiologically appropriate levels
of oxygen within a concentration range of 90-96% across a continuous
flow rate range of 0 to 5 LPM. The stationary base unit and POC user
interfaces enable user control and notification of stationary base unit
events via LED and audible alerts. F1, F2 Fuse: 5A, 250V T-LAG, NANO2

SMD, RoHS Compliant

*Per IEC 60601-1

*The variation of the flow does not exceed the greater 10% of the set value or .2
LPM when a back pressure of 7 kPa (1 psig) is applied to the device output.

†Degradation may occur for settings less than 1 LPM.

21

ACCESSORIES (ADDITIONAL/REPLACEMENT/SPARE)

The accessories listed below are for the Activox DUO2 Stationary
Base. Please refer to the LifeChoice Activox Portable Oxygen
Concentrator Operator’s Manual for a list of accessories applicable to
that unit.

Air Filter

Removes dust particles from the air entering the Stationary Base.
Included with purchase of the Activox DUO2 Standard Package.

Product Number: 131-007

External Battery Crate

Stores the External Battery while it is being charged by the stationary
base. Included with purchase of Activox DUO2 Standard Package.

Product Number: 131-004

Maintenance Tool

Used to remove the air filter during routine maintenance. Included
with purchase of Activox DUO2 Standard Package. Product Number:

131-005

Tool Holder

Attach to your DUO unit to store the Maintenance Tool. Included with
purchase of Activox DUO2 Standard Package. Product Number: 133-

160.

OXYGEN CONCENTRATION OVER ALTITUDE AND FLOW RATE

1LPM

100%

99%

98%

97%

Flow Rate

Oxygen

Oxygen Concentration Over Altitude Range 0-4000 m

96%

95%

2LPM 3LPM 4LPM 5LPM

NOTE: Stated accuracy of multi-function oxygen concentrator indicator
is +/- 2%.

DISPOSAL

Inova Labs expects end users to dispose of the Activox DUO2 system in
an environmentally friendly way. Electrical and electronic equipment
is labeled with a crossed-out wheeled bin symbol indicating that the
equipment should be disposed of by the end user separate from
other types of waste. The end users should contact Inova Labs or
their local distributor for disposal, collection and recycling options
and terms and conditions for their country. In 2002, the European
Union introduced the Directive on Waste Electrical and Electronic
Equipment (WEEE). The aim of the Directive is to ensure that WEEE is
collected and treated separately. WEEE items may contain hazardous
substances that should not end up in the human environment and can
have adverse affects on it if they do.

TECHNICAL SUPPORT

Please contact the local medical equipment company that provided
or sold you the Activox DUO2 system for any technical or emergency
support.

If any additional information is needed, please contact Inova Labs’
Customer Care Team Monday-Friday, 7:00AM-7:00PM CST at

1.512.617.1744.

SERVICE LIFE

This section outlines the defined service life of the Activox DUO2
components. The Service Life of these components is dependent on
operating and environmental conditions. Should your device indicate
an alarm that requires you to contact your equipment provider, the
provider may determine that the Activox DUO2 unit must be sent
in for service. The corresponding alarm triggered by an internal
component at the end of its service life is listed below.

Alarm TriggeredComponent

Sieve Bed Low Oxygen

Compressor Low Oxygen or Low Pressure

Solenoid Valve Low Oxygen or Low Pressure

22

23

SERVICE LIFE RECORD

Date

Serviced

Components Serviced

(Sieve Bed,

Compressor, etc.)

Unit Serviced

(Stationary or POC)

Date

Returned

In the event that a component of the Activox DUO2 System is
returned for service or repair, use this section to track the date
and details of service.

24

Date

Serviced

Components Serviced

(Sieve Bed,

Compressor, etc.)

Unit Serviced

(Stationary or POC)

Date

Returned

25

WARRANTY

LIMITED WARRANTY AND DISCLAIMER

(“Limited Warranty”)

NOTE: This Limited Warranty provides specific legal rights. Purchaser may
also have other rights which vary from state to state or country to country and
in some cases, due to applicable laws, certain limitations or exclusions of this
Limited Warranty may not apply.

Inova Labs, Inc. (“Inova Labs”) warrants solely to the first purchaser from Inova
Labs (“Purchaser”) that each new portable or stationary oxygen concentrator
unit (or any combination thereof) excluding the Sieve Bed, Accessories, and
Batteries (such new units excluding the Sieve Bed, Accessories, and Batteries
hereinafter referred to as “Product”) shall be free from defects of design,
materials, and workmanship under normal use, operation and service for
three (3) years from the date of purchase (meaning the date of purchase as
evidenced by the sales receipt from Inova Labs or its authorized distributor,
hereafter referred to as the “Date of Purchase”). The Sieve Bed is warranted
to Purchaser to be free of defects of design, materials, and workmanship
under normal use, operation and service, for one (1) year for th POC and
three (3) years for the DUO2 from the Date of Purchase. Accessories and
Batteries are warranted to Purchaser solely to be free of defects, for one
(1) year from the Date of Purchase for Accessories and Batteries. Refer to
the table below for a detailed description of the relevant timeframes under
this Limited Warranty. Product components (which include the Outer Shell,
Control Panel, Compressors, Computer Controller & Power Boards, and PSA
Lung Assembly), Sieve Beds, Accessories, and Batteries are collectively
referred to as “Items.”

ITEM LENGTH OF COVERAGE

Outer Shell (POC Housing) 3 Years (POC & Stationary)

Control Panel (POC Keypad) 3 Years (POC & Stationary)

Computer Controller & Power Boards 3 Years (POC & Stationary)

Compressors 3 Years (POC & Stationary)

PSA Lung Assembly 3 Years (POC & Stationary)

Sieve Bed 1 Year (POC); 3 years (Stationary)

Battery – Internal 1 Year (POC)

Battery – External/Supplemental 1 Year (POC)

Accessories 1 Year (POC & Stationary)

26

The Limited Warranty extends only to the Purchaser and is not transferable
unless otherwise expressly agreed to in writing by Inova Labs.

Inova Labs’ oxygen concentrators produce enriched oxygen gas which
accelerates combustion. DO NOT ALLOW SMOKING OR OPEN FLAMES
within ten (10) feet (three (3) meters) of these devices while in use. A user’s
SMOKING of any kind (including cigarette, cigar, and pipe) while using
Product, and evidence that a user has smoked while using the Product, will
void all warranties with respect to that Product and related Items.

An extended warranty on the Product is available at a maximum of two (2)
additional years and must be purchased at the time of the original Date of
Purchase. An extended warranty on the Product covers components included
in the Standard Package (POC, Sieve Bed, Accessories and Internal Battery).
Extended warranties are offered to Purchaser only and are non-transferrable
unless otherwise expressly agreed to in writing by Inova Labs.

The Limited Warranty excludes from coverage any damage, failure, or
malfunction caused by or related to:

a. Abuse, misuse, negligence or accident;
b. Failure to comply with instructions contained in the Operator’s Manual;
c. Alteration, tampering, or modification by someone other than an

authorized Inova Labs representative;
d. Unauthorized repairs or alterations;
e. Environmental conditions (including but not limited to water, flame,

chemicals, fumes in the atmosphere, extreme heat or cold, food or

liquid, sand, dirt or the like);
f . Lack of regular, preventive maintenance and cleaning;
g. Damage in shipment to Inova Labs;
h. Other acts beyond the reasonable control of Inova Labs; and
i. Any damage caused by improper packaging when returning Items to

Inova Labs.

Warranty Service and Coverage

PURCHASER’S EXCLUSIVE REMEDY AND INOVA LABS’S SOLE OBLIGATION
HEREUNDER SHALL BE LIMITED TO REPAIR OR REPLACEMENT OF THE
DEFECTIVE ITEM OR REFUND OF THE APPLICABLE PURCHASE PRICE, AT
INOVA LABS’ OPTION.

Inova Lab’s warranty obligations hereunder are conditioned upon Purchaser’s
compliance with the warranty procedures set forth herein. If an Item fails
to conform to the Limited Warranty set forth herein, Purchaser must give
prompt written notice to Inova Labs (with such notice in no event beyond
the applicable warranty period), at which time Inova Labs or its authorized
distributor will issue a Return Material Authorization (“RMA”) number. All
Items claimed to be defective within the warranty period shall be properly
packaged and shipped on a prepaid basis to Inova Labs (USA sales) or
its authorized service center at Purchaser’s expense. The exterior of the

WARRANTY

continued

27

WARRANTY

continued

shipping container must clearly display the RMA number which properly
identifies returned Items and the Item must be packaged together with proof
of Date of Purchase. Items returned without a proper RMA number shall be
refused and returned to Purchaser at Purchaser’s expense. All returned Items
are subject to warranty confirmation by Inova Labs. Inova Labs shall pay
for standard shipment back to Purchaser for repair or replacement of Items
properly covered under this Limited Warranty.

When repairing or replacing the Item, Inova Labs may use functionally
equivalent Products or parts that are new, equivalent to new or refurbished.
All parts removed in the replacement of any Item shall become the property
of Inova Labs.

To the full extent permitted under applicable law, the warranty coverage
will not be extended or renewed or otherwise affected due to Inova Labs’s
authorized repair or replacement. However, part(s) repaired or replacement
Items will be warranted for the unexpired portion of the original Limited
Warranty.

Disclaimer of Warranties.

NO REPRESENTATIVE OF INOVA LABS HAS AUTHORITY TO MAKE
ANY REPRESENTATIONS OR PROMISES EXCEPT AS EXPRESSLY
STATED HEREIN. NO AGREEMENT VARYING OR EXTENDING THIS
LIMITED WARRANTY SHALL BE BINDING UPON INOVA LABS UNLESS
IN WRITING, SIGNED BY A DULY AUTHORIZED REPRESENTATIVE OF
INOVA LABS. THIS LIMITED WARRANTY IS EXCLUSIVE AND GIVEN
AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES,
AND TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE
LAW INOVA LABS EXPRESSLY DISCLAIMS ANY AND ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

Limitation of Liability.

TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW,
IN NO EVENT SHALL INOVA LABS HAVE ANY LIABILITY FOR ANY
CONSEQUENTIAL, SPECIAL, INCIDENTAL, INDIRECT, EXEMPLARY
OR PUNITIVE DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST
PROFITS, LOSS OF USE AND LOST REVENUE, REGARDLESS OF THE
FORM OF THE CLAIM, WHETHER IN CONTRACT, TORT, NEGLIGENCE,
STRICT LIABILITY OR OTHERWISE, ARISING OUT OF OR RELATING
TO INOVA LABS’ ITEMS, MATERIALS AND/OR SERVICES, AND EVEN
IF INOVA LABS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE
LAW, INOVA LABS’ LIABILITY HEREUNDER OR RELATING HERETO
SHALL NOT EXCEED THE PURCHASE PRICE PAID FOR THE ITEMS,
REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY
ACTION OR CLAIM IS BASED ON CONTRACT, TORT, NEGLIGENCE,

28

WARRANTY

continued

STRICT LIABILITY OR OTHERWISE. PURCHASER AGREES AND
ACKNOWLEDGES THAT THE ITEMS ARE OF A SIZE, DESIGN AND
CAPACITY SELECTED BY ITS MEDICAL PROVIDER.

Basis of Bargain

PURCHASER ACCEPTS THESE DISCLAIMERS OF WARRANTIES AND
LIMITATIONS OF LIABILITY CONTAINED HEREIN AS PART OF A
BARGAIN WITH RESPECT TO THE PRICING OF THE ITEMS AND
UNDERSTANDS THAT THE PRICING WOULD LIKELY BE HIGHER IF
INOVA LABS WERE REQUIRED TO BEAR LIABILITY IN EXCESS OF
THAT STATED HEREIN. ALL OF THE LIMITATIONS AND DISCLAIMERS
SET FORTH HEREIN SHALL APPLY NOTWITHSTANDING THE FAILURE
OF THE ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

Governing Law and Jurisdiction

The rights and obligations of the parties pursuant to this Limited Warranty
and any dispute arising hereunder shall be governed by and interpreted in
accordance with the internal (but not the conflicts) laws of the State of Texas,
USA. The 1980 U.N. Convention on Contracts for the International Sale of
Goods shall not apply. If any provision of this Limited Warranty is inconsistent
with applicable laws relating to Purchaser, Purchaser agrees to waive any and
all rights and remedies it may have under such laws to the extent it may waive
such rights and remedies. This Limited Warranty is offered as an additional
benefit to Purchaser’s statutory rights and it does not affect such statutory
rights in any way. The parties agree and consent that the state or federal
courts in Texas shall have exclusive jurisdiction with respect to any dispute
arising out of or relating to this Limited Warranty. If any provision of this
Limited Warranty is held to be illegal or unenforceable, that provision will
be limited or eliminated to the minimum extent necessary so that this Limited
Warranty will otherwise remain in full force and effect and enforceable.
EACH PARTY EXPRESSLY WAIVES ALL RIGHTS TO A TRIAL BY JURY.

Technical Support

Inova Labs’ Customer Care Team can be reached Monday-Friday, 7:00AM­7:00PM CST at 1.512.617.1744.

29

EMC INFORMATION

Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided in the accompanying tables.

The Activox DUO2™ Stationary Base is intended for use in the electromagnetic
environment specified below. The customer or end user of the model 130­001 should assure that it is used in such an environment.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity and
Emissions

Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level Environment - Guidance

Floors should be wood,

concrete or ceramic tile.

If floors are covered with

synthetic material, the

relative humidity should

be at least 30%.

+/- 2, 4, 8 kV

Air Direct

+/- 2, 4, 8 kV

Contact Direct

+/- 2, 4, 8 kV

Contact Indirect

+/- 2, 4, 8 kV

Air Direct

+/- 2, 4, 8 kV

Contact Direct

+/- 2, 4, 8 kV

Contact Indirect

Electrostatic

Discharge (ESD)

IEC 61000-4-2

Power frequency magnetic

fields should be at levels
characteristic of a typical

commercial or hospital

environment.

3 A/m 3 A/m

Power Frequency

(50/60Hz)

Magnetic Field

IEC 61000-4-8

Mains power quality

should be that of a typical

commercial or hospital

environment.

+/-2 kV for

power

supply lines

+/-2 kV for

power

supply lines

Electrical Fast

Transient/Burst

IEC 61000-4-4

Mains power quality

should be that of a typical

commercial or hospital

environment.

± 0.5 kV, ± 1

kV differential

mode

± 0.5 kV, ± 1 kV,

± 2 kV common

mode

± 0.5 kV, ± 1 kV

differential mode

± 0.5 kV, ± 1 kV,

± 2 kV common

mode

Surge

IEC 61000-4-5

Mains power quality

should be that of a typical

commercial or hospital

environment. If the user of the

model REF 130-002 requires

continued operation during

power mains interruptions,

it is recommended that

the oxygen concentrator

be powered from an

uninterrupted power supply

or battery.

< 5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% U

T

(30% dip in UT)

for 25 cycles

< 5% UT

(>95% dip in UT)

for 5 seconds

< 5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% U

T

(30% dip in UT)

for 25 cycles

< 5% UT

(>95% dip in UT)

for 5 seconds

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level Environment - Guidance

Portable and mobile RF
communications equipment
should be used no closer to

any part of the model REF

130-002, including cables,

than the recommended

separation distance

calculated from the equation

applicable to the frequency

of the transmitter.

d = [ ]√P 80 MHz to

800 MHz

d = [ ] √P 800 MHz to

2.5 GHz

Where ‘P’ is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and ‘d’ is the
recommended separation
distance in meters (m).

Field strengths from fixed RF
transmitters, as determined
by an electromagnetic
site survey,a should be less
than the compliance level in
each frequency range.

b

Interference may occur in the
vicinity of equipment marked
with the following symbol:

3 Vrms

150kHz-80MHz

3 V/m

80MHz-2.5GHz

3 V

3 V/m

Conducted RF
IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3.5
V1

7

E1

NOTE 1: UT is the a.c. mains voltage prior to application of the test level.

NOTE 2: At 80MHz and 800MHz, the higher frequency range applies.

NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in
which the model 130-001 is to be used exceeds the applicable RF compliance
level above, the model 130-001 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the model 130-001.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

EMC

INFORMATION

continued

30

EMC
INFORMATION

continued

The model 130-001 is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user
of the model 130-001 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the model 130-001
as recommended below, according to the maximum output power of the
communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where p is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.

Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and The Activox DUO2 Stationary Base Model

130-001.

Separation Distance According to the Frequency of Transmitter (m)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.74

1 1.2 1.2 2.3

10 3.8 3.8 7.4

100 12 12 23

Rated Maximum

Output Power of
Transmitter (W)

150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz

  d=[]√P d=[]√P d=[]√P

3.5
V1

3.5
E1

7

E1

Emissions Test

Compliance

Electromagnetic Environment - Guidance

The model 130-001 use RF energy only for its

internal function. Therefore, its RF emissions

are very low and are not likely to cause any

interference to nearby electronic equipment.

RF Emissions, CISPR 11

RF Emissions, CISPR 11

Harmonic Emissions,

IEC 61000-3-2

Voltage Fluctuations/Flicker

Emissions, IEC 61000-3-3

Group 1

Class B

N/A

N/A

The model 130-001 are suitable for use

in all establishments, including domestic

establishments and those directly connected to

the public low-voltage power supply network

that supplies buildings used for domestic

purposes.

31

32

PROVIDER INSTRUCTIONS

BATTERY CHARGING

Connection of the Activox POC to the DUO2 Stationary Base (No
External Battery)

4L -When the POC is connected to the stationary base, it will generate
a short audible beep tone. The POC display will read “Charging
Internal” until the internal battery is fully charged when “Charging
Internal” goes away. The Battery Charge LED on the stationary base
will not turn on.

Pro & Sport - When the POC is connected to the stationary base, it will
generate a short audible beep tone. The three LEDs for LPM 1, 2, and 3
will remain on. The green LED for INT will remain on until the internal
battery is fully charged when it turns off. The Battery Charge LED on
the stationary base will not turn on.

Connection of the Activox POC and an External Battery to the
DUO2 Stationary Base

4L -The external battery will begin charging AFTER the internal battery
of the POC is completely charged. The “Battery Charge” green LED
on the stationary base will flash until the external battery is completely
charged when it stops flashing and remains solid green. The POC will
NOT show the External Battery icon.

Pro & Sport - The external battery will begin charging AFTER the
internal battery of the POC is completely charged. The “Battery
Charge” green LED on the stationary base will flash until the external
battery is completely charged when it stops flashing and remains solid
green. The POC EXT LED will not illuminate.

Connection of ONLY an External Battery to the DUO2 Stationary
Base

4L -The “Battery Charge” green LED on the stationary base will flash
until the external battery is completely charged. Once fully charged,
it stops flashing and remains solid green.

Pro & Sport - The “Battery Charge” green LED on the stationary base
will flash until the external battery is completely charged when it stops
flashing and remains solid green.

33

CHECK HOURS

When the Activox POC is connected to the DUO2 Stationary Base, the POC will provide the
hours of operation for the Stationary Base. When disconnected, the POC will provide the
hours of operation of the POC.

MUTE BUTTON

When connected to the DUO2 Stationary Base, the Activox POC “Mute” button can be pressed
to mute the audible tone of the stationary base alarm

4L -When the Stationary DUO2 produces an alarm, depress the POC “Mute” button and the audible
tone will be muted. The red “Alarm” LED on the stationary base will remain on. The POC display
will show the “Mute” icon. To un-mute, press the POC “Mute” button again.

Pro & Sport - When the Stationary DUO2 produces an alarm, depress the POC “Mute” button and
the audible tone will be muted. The RED “Alarm” LED on the stationary base will remain on. The
amber LED next to the “Mute” button will turn on. To “un-mute” press the POC “Mute” button
again.