Inova Labs Inc. DUO2 User manual

Manufactured for & Distributed by

3500 Comsouth Drive, Suite 100, Austin, Texas 78744 USA

Corporate Office 1.512.617.1700 | www.InovaLabs.com

@InovaLifeChoice

Manufactured for & Distributed by

www.InovaLabs.com

Operator’s Manual

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

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 non-

grounded 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.

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Inova Labs Inc. DUO2 User manual

Inova Labs Inc. DUO2 User manual

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