LifeChoice Activox TM Portable Oxygen Concentrator Operator’s Manual

Copyright © 20 12 In ova 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 , Inc.

Find us on the World Wide Web at:

www. inovalabs.com

Inova Labs Inc.

3500 Comsouth Drive, Suite 100
Austin,TX 78744 USA

www. Inovalabs.com

Phone: 1.800.220.0977TABLE OF CONTENTS

Introduction 1

Application 1

- In dication s for Use 1

Symbol Descriptions 1

Warnings 2

User Controls 3

LifeChoice Activox Standard Package 5

LifeChoice Activox P art Names 5

Operating Instructions 6

- Before Using the LifeChoice Activox for the First Time 6

- Powering the LifeChoice Activox 6

- Battery Charging 7

Operating Procedure 8

Alarms/Light Indicators 9

Routine Maintenance 1 1

Specifications 1 2

Warranty 16

Accessories 19

Disposal 2 0LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 1 INTRODUCTION

Th e patient manual will provide familia rity with the LifeChoice Activox Portable Oxygen Concentrator (POC) and its accessories. Be sure to read all of the enclosed information in its entirety before using the LifeChoice Activox POC. The LifeChoice Activox POC is an internally powered, type BF device when powered by the internal battery and a Class II, Type BF device when connected to the external AC Adapter/Charger , DC Adapter/Charger or rechargeable battery. The essential performance of the LifeChoice Activox POC 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 concentration or no breath) and create an alarm is also considered a part of essential perfor mance.

APPLICATION

This manual applies to the LifeChoice Activox POC Model XYC100.

INDICATIONS FOR USE: The LifeChoice Activox Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This

oxy gen 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,

institution or travel environment. The LifeChoice Activox is also portable.

The LifeChoice Activox POC is pending FAA approved for air travel. T he required FAA label

locat ion is on the bottom of the LifeChoice Activox POC. The FAA a pproved POC list will

show Inova Labs LifeChoice Activox . Every airline has specific information required for traveling wit h oxygen. Before traveling, review your airline’s specific requirements. The Inova Labs website contains additional information at www.Inovalabs.com/resources.

SYMBOL DESCRIPTIONSLifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 2 WARNINGS

1. This device is NOT INTENDED to be life

- sustaining or life

- supporting.

2. This device should be used only when prescribed by a physician.

3. In certain circumstances, oxygen therapy can be hazardous. Please seek medical advice before using the LifeChoice Activox POC.

4. U.S. Federal law restricts this device to sale by or on the order of a physician.

5. The LifeChoice Activox POC is designed to provide a flow of high purity oxygen. Patients with a fast breathing rate or requiring high oxygen flow may require more oxygen than the

LifeChoice Activox POC can prod uce and, therefore, may not be a suitable candidate.

6. This device is not suitable for patients who are unable to hear or see alarms or communicate discomfort. If the patient shows any signs of discomfort, a physician should be consulted immediately.

7. I t is the responsibility of the patient and/or provider to make back

- up arrangements for an alternative oxygen supply when traveling; Inova Labs Inc. assumes no liability for persons choosing not to adhere to manufacturer recommendations.

8. Availability of an alternate source of oxygen is required in case of power outage or mechanical failure. Consult your physician or medical equipment supplier for the type of

back

- up system required.

9. The LifeChoice Activox POC is designed to be used in the provided/app roved carry case.

10. The LifeChoice Activox should be located so as to avoid pollutants or fumes.

11. The LifeChoice Activox POC does not require the use of any lubricants. Do not use oil, grease or petroleum

- based products on or near the LifeChoice Activox POC. Do not use power supplies/adapters, carry bags or accessories other than those which come with the

LifeChoice Activox POC. The use of non

- specified accessories may impair equipment performance and will void all warranties.

12. The LifeChoice A ctivox POC produces enriched oxygen gas which accelerates combustion. DO NOT ALLOW SMOKING OR OPEN FLAMES within 10 feet (3 meters) of this device while in use. Cigarette/cigar/pipe SMOKING while using the LifeChoice Activox

POC will VOID all warranties.

1 3. Never operate the LifeChoice Activo x POC in the accessory bag. This is provided for accessories only.

14. Do not submerge the LifeChoice Activox POC or any of the accessories in liquid. Do not expose to water or precipitation. Do not operate in rain. Th is could lead to damage.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 3 15. Portable and mobile RF c ommunications equipment can a ffect medical electrical
equipment.

16. The LifeChoice Activox POC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, th e LifeChoice Activox POC should be observed to verify normal operation in the configuration in which it will be used.

DANGER: No smoking or Open Flame

USER CONTROLS

The user controls on the LifeChoice Activox POC are specifically designed to be pressed by a finger. Never press any of the buttons with a pen, screwdriver, stylus or any other object. Pressing the buttons with any hard, sharp and/or small object can damage the user

controls and void all warranties

. The following items are essential parts of the user controls

for the LifeChoice Activox POC:

Indicator Lights: Colored lights indicate either a change in operating status or a condition that may need response (alarm).

Audible Signals: An audible signal (beep) indicates either a change in operating status or a condition that may need response (alarm).

Nasal Cannula: A standard single lumen nasal cannula or equivalent must be used with the

LifeChoice Activox POC to provide oxygen from the concentrator. A standard single lumen type cannula, 7

- foot (2

- meter), is recommended for use. An Adult Nasal Cannula is supplied

with each LifeChoice Activox POC . For replacement cannulas, please contact your local medical equipment supplier. Follow cleaning and care ins tructions provided with the nasal

cannula.

Caution: Use of some administration accessories not specified for use with this oxygen concentrator may impair the performance.

Auto Mode LEDs : There are two inhalation sensitivity modes on the control panel: Active

High and Sleep

- Low , which automatically adjust based on oxygen requirements. (Reference below diagram.)

Pulse Setting Control Buttons: There are three individual P u lse Setting B utton s on the control panel: 1, 2

, and 3 which are equivalent to 1, 2

, or 3 liters per minute (LPM) settings

on a continuous flow device. (Reference Control Panel diagram.)

Hour Meter Button: The LifeChoice Activox POC will read and display the number of

hours that the unit has been used. (Refer to Routine Maintenance section .)LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 4 Mute Button: The LifeChoice Activox POC features a mute function to disable audible

alarms during operation

. If an alarm has been muted, the yellow Mute LED will be

illuminated. (Reference Control Panel diagram.)

Battery Check Button: The Battery Check Button causes the battery charge level to be displayed

. (Reference Control Panel diagram.)

Battery Charge Ind icator : The Battery Charge Indicator consists of four LEDs labeled “25%”, “50%”, “75%”, and “100%”. (Reference Control Panel diagram.)

Charge

- level indication is approximate except at full charge when all four LEDs are solid
green. Use the following examples to interpret other charge levels:

Charge Level 25% LED 50% LED 75% LED 100% LED

37% Solid Green Flashing Green Off Off

50% Solid Green Solid Green Off Off

65% Solid Green Solid Green Flashing Green Off

100% Solid Green Solid Green Solid Green Solid Green

LifeChoice Activox Control PanelLifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 5 LIFECHOICE ACTIVOX POC STANDARD PACKAGE

The LifeChoice Activox POC can be operated using AC power, DC power or battery power during transport while inside the approved carry case. The STANDARD PACKAGE includes the following items:

(1) 4

- Way Carry Case Use as a convertible backpack, over

- the

- shoulder strap, briefcase or waist pack

(2) Standard single lumen 7

- foot (2

- meter) long nasal cannula

(3) LifeCho ice Activox Accessory Bag

(4) LifeCho ice Activox Portable Oxygen Concentrator with up to 7

- hour internal battery ( Refer to Battery Life table since actual time will vary depending upon breath rate and

dose. )

(5) AC Adapter/Charger (universal 100v

– 240v; 50hz

– 60hz)

(6) DC Adapter/Charger (12v) with standard “car” adapter plug

An External Battery is available for purchase separately which provide s up to 4 hours of additional portable time. ( Refer to Battery Life table since actual time will vary depending upon breath rate and dose. )

LIF ECHOICE ACTIVOX POC PART NAMES

External Battery Port : Connect external battery (if used) to this port. (This connection is to be used solely with the specified external battery.)

Cannula Nozzle Fitting: The nasal cannula connects to the oxygen output nozzle at the top

of the LifeChoice Activox POC. Do not place the cannula into nasal passages until the

LifeChoice Activox POC is fully powered on. Breathing through the cannula during start

- up will prevent the system from powering on.

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

Fan Outlet Vent : Cooling air is exhausted through this opening.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 6 OPERATING INSTRUCTIONS

BEFORE USING THE LIFECHOICE ACTIVOX POC FOR THE FIRST TIME

The LifeChoice Activox POC should be charged for a minimum of four hours before initial

use. Begin charging by c onnect ing the AC Adapter/Charger to the LifeChoice Activox POC and plug ging it into an electrical outlet.

Make sure to verify that t he Battery Che ck LED labeled “INT” is solid green. This indicates that the system recognizes the external power source and is charging the internal battery

.

If an external battery was purchased with the LifeChoice Activox POC, connect it to the External Battery P ort. It should take approximately three hours to fully charge the external battery (with internal battery already fully charged), and seven hours to charge both the internal and external batteries together. (See Battery Charging section for more details)

U n les s an optional external battery charger has be en purchased separately , t he external

b attery can only be charged when connected directly to the LifeChoice Activ o x POC. (C ontact your local medical equipment provider or customer support fo r information on

purc hasing the optional charger

. )

The LifeChoice Activox POC is recommended and designed to be operated and stored in its

carry ing case at all times.

Connect the nasal cannula securely to the LifeChoice Activox POC cannula nozzle fitting.

POWERING THE LIFECHOICE ACTIVOX

The LifeChoice Activox POC can be powered in four different ways: (1) internal battery, (2)

AC Adapter/Charger

, (3) DC Adapter/Charger

, or (4) external battery (optional, sold separately from the STANDARD PACKAGE)

.

The f ollowing specific s apply to each of the four modes (listed above) of powering the

LifeChoice Activox POC:

1. Internal Battery: A rechargeable internal battery is located within each

LifeChoice Activox POC unit. When fully charged, it supplies power to the Life

Choice Activox POC for up to seven hours. ( Refer to Battery Life table since actual time will vary depending upon breath rate and Pulse Setting. )

When the LifeChoice Activox POC is being powered from the internal battery , the Battery Check LED labeled “INT” will be slowly flashing. Pushing the Battery Check Button will display the charge level of the internal battery.

If not connected to the AC or DC Adapter/Charger the internal battery will slowly discharge over time even when not in use. Always check the b attery level prior to use to ensure adequate charge level

.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 7 2. AC Adapter/Charger : An AC Adapter/Charger allows the LifeChoice Activox

POC to be powered from a standard 100

- 240 VAC , 50/60 Hz outlet. Wh en the unit is operated from an AC Adapter/Charger , power from the AC outlet powers

the unit and r echarges the internal and/or external battery. ( See Battery Charging section below for deta i ls. )

Using an AC Adapter/Charger that is not specified by Inova Labs for use with the

LifeChoice Activox POC may damage the unit and will void all warranties.

3. DC Adapter/Charger : A DC Adapter/Charger can be connected from the

LifeChoice Activox POC unit to a vehicle ’s ( car, boat, motor home, etc.) standard

12 V DC outlet. When the system is connect ed to the DC ou tlet, power from the vehicle battery powers the LifeChoice Activox POC unit and re charges the internal and/or external battery . (See Battery Charging section below for details.)

The 12 VDC outlets in s ome pre

- 2000 model car s will not provide sufficient

current to operate the POC and charge the battery at the same time

. Verify that any DC outlet used can provide at least 10 amps at 12 V DC

.

4. External Battery: To power the LifeChoice Activox POC from an external battery, connect the external battery to the external battery connector port. A fully charged external battery will supply power to the Life Choice Activox POC for up to three

- and

- a

- half hours. ( Refer to Battery Life table since actual time will vary depending upon breath rate and Pulse Setting. )

When the LifeChoice Activox POC is being powered from the external battery

, the Battery Check LED labeled “EXT” will be slowly flashing. Pushing the Battery Check Button will display the charge level of the external battery.

Note: After turning on the Lif eChoice Activox POC

, allow 30 seconds for the unit to reach stated performance.

BATTERY CHARGING

To charge the internal and/ or external battery , connect the LifeChoice Activox POC to

either an AC or DC Adapter/Charger and a suitable outlet

. If the external battery is being charged also connect the external battery to the External Battery Port. Confirm that one of the Battery Check LED s, either “INT” or “EXT”, is solid green . This indicates that an AC or

DC external power source has been recognized and that battery charging is in progress

.

If an external battery is connected to the LifeChoice Activox POC , it is important to understand the battery charging sequence. By design the internal battery is charged first.

That means that the external batte ry will not start charging until the internal battery is charged to a 100% level. Use the “INT” and “EXT” Battery Check LEDs to determine which (if any) batteries are charging.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 8 To check the battery charge level while charging is in progress, p ress the Battery Check

B utton. The charge level will be displayed as indicated in the Battery Charge Indicator section (see User Controls). When a battery is fully charged, the corresponding Battery Check LED (“INT” or “EXT”) will be off.

It takes a minimum of four hours for a fully discharged internal battery to reach a 100% charge level

. If both internal and external batteries are full discharged it can take up to seven hours to achieve a 100% charge level in both batteries.

It is rec ommended to recharge th e batteries , even if only partially depleted, as often as possible. The batteries cannot be overcharged, and it is recommended to leave the

LifeChoice Activox POC plugged in via the AC or DC Adapter/Charger as often as possible.

The rechargeable batteries are maintenance

- free and can only be exchanged at the factory.

(Note: If the LifeChoice Activox POC is powered off and either the AC or DC Adapter/Chargers are connect ed to the LifeChoice Activox POC after charging is complete

, the internal fan s may cont inue to operate for an additional period of time until the temperature inside the unit is sufficiently cool. )

OPERATING PROCEDURE

1. Locate and position the LifeChoice Activox POC so that the air inlets and air outlets are not obstructed. The unit, particularly the air intake slots and the air outlets area, should be

located in a well

- ventilated space.

2. Power the LifeChoice Activox POC using one of the four modes described i n the Powering

the LifeChoice Activox section above

.

3. Press the P ower Button once to turn “ON”. An audible beep will occur and the Power

LED

, the Auto Mode Active

- High LED and the Pulse Setting of 1 LED will illuminate solid

green . This indicates that the LifeChoice Activox POC is powered on, is ready for use, and

that settings ma y now be changed. Pressing the Power B utton for an extended time after

the audible beep will cause the system to turn back “OFF”

.

CAUTION: Do not place the cannula into nasal passages until the LifeChoice Activox POC is fully powered on. Breathing through the cannula during start

- up will prevent the system from powering on.

4. There are two inhalation sensitivity modes on the control panel: Active

- High and Sleep

Low , which automatically adjust based on oxygen requirements. No action is required to

start the de livery of oxygen.

5. Select a Pulse Se tting of 1, 2

, or 3 as prescribed by your doctor. These settings are equivalent to 1, 2, or 3 LPM settings on a continuou s flow device. The green LED above theLifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 9 selected setting illuminates and will flash each time inhalation is detected indicating that a pulse

- wave of oxygen has been delivered.

6. Place the nasal cannula in the nasal passages and breathe normally. When the LifeChoice

Activox POC senses inhalation, oxygen is supplied through the cannula. The duration and size of the pulse is dependent upon the P u lse Se tting selected.

7. Check to make sure your unit’s battery is fully charged before venturing out with the

LifeChoice Activox POC for the first time

. Refer to the Battery Charge Indicator section (see User Controls)

.

8. To turn the LifeChoice Activox POC “OFF” , press the Power B utton and hold for 2 seconds until the green Power LED goes off and the unit shuts off. After the LifeChoice Activox POC
is pow ered off, the internal fans may continue to operate for an additional period of time until the temperature inside the unit is sufficiently cool

.

ALARMS/LIGHT INDICATORS

NORMAL OPERATION INDICATORS

Normal Operation Audible Alert Light Indication Action

LifeChoice Activox

POC turned on Brief Audible Tone Green LEDs of

Power

, Active

- High

and Pulse Setting of 1

are illuminated. You may begin to use

the LifeChoice

Activox POC unit in

30 seconds

LifeChoice Activox

POC has detected an inhalation/breath and is delivering a pulse of oxygen None Green LED of selected pulse

s etting flashes with

each breath LifeChoice Activox

POC is functioning normally

LifeChoice Activox POC powered by internal battery No ne Gree n B attery Check

LED labeled “INT” slowly flashe s LifeChoice Activox

POC is functioning normally

LifeChoice Activox POC plugged into or powered by an external source (AC,
DC, or external battery) No ne Green Battery Check

LED labeled “INT” is solid green LifeChoice Activox

POC is functioning normallyLifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 10 ALARM TABLE

Problem Audible Alarm Light Alarm Action

No breath detected by the unit for approximately 75

seconds Intermittent b eep Red Alarm LED

flashes Check the cannula

connection. Ensure that you are

b reathing through your nose. After the system detects a
breath, the alarm

will shut off. If the alarm persists,

contact your equipment provider. Low Battery Alarm (Approximately 10 minutes of battery power) Single loud, long

beep every 60

seconds. Amber Battery Check

LED labeled “INT” slowly flashe s Connect the

LifeChoice Activox

POC unit to an external power

source , or change to

another source of

oxygen.
Critical Low Battery

Alarm (Approximately 3 0

second s of battery power) Fast audible beep

(Unit shuts down) Amber Battery Check

LED labeled “INT” begins flashing quickly Connect the

LifeChoice Activox

POC unit to an external power

source , or change to

another source of

oxygen.
General malfunction

of the LifeChoice

Activox POC Continuous audible

al arm A larm LED is solid

red Turn off the unit.

Change to another source of oxygen, and contact your equipment provider.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 11 ROUTINE MAINTENANCE

The LifeChoice Activox doe s not have any end

- user repairable parts.

Intake Vent Cleaning: There is o ne intake vent located on the lower

- right side (facing the unit) of the LifeChoice Activox POC. The carrying case for the unit has mesh material corresponding to the location of the intake vent. You should visually check the carrying

case to ensure that there is no build

- up of lint, hair or other materials that could obstruct the flow of air into the unit’s intake vent. Remove any material build

- up using a soft brush.

At least once a month inspect the grille of the intake vent and if it appear s dirty, use a dry cotton swab (Q

- Tip® or similar) to clean it. Never use alcohol, solvents, or petroleum distillates for cleaning.

Carrying Case Cleaning : If it is necessary to clean the carrying case , use only warm water and a mild liquid dish detergent.

1. Before starting m ake sure the carrying case is closed.

2. Dampen a cloth in the detergent and water solution and wipe the outside surfaces of

the case clean.

Warning: D o not use alcohol, solvents, polishes or any oily substances since they may

be flammable.

Nasal Cannula Inspection: At least once a week, visually inspect the nasal cannula. Make sure there are no kinks or obstructions. Replace as needed with a s tandard 7

- foot (2

- meter) single

- lumen type cannula from your local medical equipment supplier.

Reserve Oxygen Supply: Your equipment provider should provide or suggest an alternative source of supplemental oxygen therapy in case there is a mechanical failure or

power outage.

Hour Meter: The hour meter function is typically only used by service personnel. To displ ay cumulative running hours push the Hour Meter Button for a minimum of two

seconds. The control panel LEDs listed below will then blink to establish an hour count.

The Sleep

- Low LED represents 10,000s of hours and the Active

- High LED represents

1,000s o f hours. The Pulse Setting of 1 LED represents 100s of hours. The Pulse Setting of 2 LED represents 10s of hours and the Pulse Setting of 3 LED represents 1s of hours.

The order of LED blinking starts with 10,000s of hours and ends with units of hours. If the value of a particular position is zero, the corresponding LED will not blink. For example, given an hour value of 987, neither the Sleep

- Low LED nor the Active

- High LED will blink. The first LED to blink with be the Pulse Setting of 1 LED and it will blink nine times.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 12 SPECIFICATIONS

Maximum outlet pressure: 19 psi (131 kPa)

Device Electrical Classification: Class II , Type BF Oxygen Concentration: 90% (+/

- 5 %) Oxygen Concentration Sensor Alarm: Less than 85 % for 16 consecutive breaths (+/

- 1.5%

accuracy over the operational range of LifeChoice Activox given below ) Flow Control Pulse Settings: 1, 2

, & 3 LPM (Equivalent to Continuous Flow) ±20% Mode of Operation: Continuous equipment and mobility: portable Weight: 5.0 Pounds (2.2kg)

Di mensions: 9.05 " Width x 7.875 " Height x 4. 38” Depth
Power Requirement: AC 10 0 to 240 VAC, 50 to 60 Hz; DC 12 to 19 VDC or Battery 12

- 16.8

VDC

LifeChoice Activox POC Input: 19VDC , 6A

External AC Power Adapter/Charger , XYC103AC

- Input: 100

- 240V AC , 2.5A ; Output: 19V,

6.3A

External DC Power Adapter/Charger , XYC104DC

- Input: 11.5

- 16VDC, 10 A; Output: 19V,

6.3A External Rechargeable Battery, XYC102 B Approximate Internal Battery Duration: See Battery Life T able Minimum Internal Battery Recharge Time: 4 Hours Sound: Less than 50 Decibels at 10 ft (3.05m), 54.4 Decibels at 3.3ft (1m)

Environmental Conditions for Use, Storage and Transport: Operational Temperature: 41 °F to 104 °F ( 5 ° C to 40 °C ) Operational Humidity Range: 15 % to 9 3 %, Non

- condensing Operational Al titude Max: 10,000 Feet (3km)

Storage Temperature:

- 25 °F to 140°F (

- 32 ° C to 60°C) Storage Humidity Range:

BATTERY LIFE TABLE

Run Time (@15 BPM) Pulse Setting

1 LPMeq 2 LPMeq 3 LPMeq

Internal Battery 7 Hours 6 Hours 4 Hours

External Battery 3.5 Hours 3 .5 Hours 2 HoursLifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 13 O XYGEN CONCENTRATION OVER ALTITUDE AND FLOW R ATE

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.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 14LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 15LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 16 WARRANTY (USA)

INOVA LABS, INC.

LIMITED WARRANTY AND DISCLAIMER

(“Limited Warranty”)

NOTE : This Limited Warranty does not affect Purchaser’s statutory rights under applicable national laws.

Inova Labs, Inc. (“Inova Labs”) warrants that each new LifeChoice ActivoxTM Portable Oxygen Concentrator (“POC”) shall be free from defects under normal use, operation and service for three (3) years. Any LifeChoice
ActivoxTM POC Accessories, the Sieve Bed and all Batteries are warranted for one (1) year. See the table below for detailed coverage under this Limited Warranty.

The Limited Warranty extends only to the first Purchaser (it is not transferable) and begins on the date of purchase as evidenced by the sales receipt directly from Inova Labs or through one of its authorized distributors. This Limited Warranty is only offered in connection with sales through Inova Labs’ authorized

distribution channels.

The LifeChoice ActivoxTM POC produces enriched oxygen gas which accelerates combustion. DO NOT ALLOW

SMOKING OR OPEN FLAMES within 10 feet (3 meters) of this device while in use. Cigarette/cigar/pipe SMOKING while using the LifeChoice ActivoxTM POC will VOID all warranties.

Extended Warranty is available

- two additional years maximum. Extended warranty covers the same components as the limited 3 year warranty. Batteries, sieve bed replacement and accessories remain at one year warranty. Extended warranties are offered to th e original owner only and are non

- transferrable. Extended warranties must be purchased at the time of original purchase of the LifeChoice ActivoxTM.

ITEM LENGTH OF COVERAGE

Outer Shell 3 years

Com pressors 3 years Computer Controller & Power Boards 3 years PSA Lung Assembly 3 years

Sieve Bed 1 year
Battery

– Internal 1 year
Battery

– External/Supplemental 1 year

Accessories 1 year

The Limited Warranty Excludes From Coverage

1. Defects caused by or related to:

a. Abuse, misuse, negligence or accident;

b. Failure to comply with instructions contained in the Operating Manual;

c. Alteration or modification by Purchaser;

d. Unauthorized repairs or alterations;

e. Environmental conditions (including but not limited to water, chemicals, fumes in the atmosphere, extreme heat, spillage of food or liquid, sand, dirt or the like);

f. Lack of regular, preventive maintenance and cleaning;

g. Damage in shipment;

h. Other acts beyond the reasonable control of Inova Labs.

i. Any damage caused by improper packaging when returning product to Inova Labs Inc.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 17 Warranty Service and Coverage Purchaser’s exclusive remedy and Inova Labs’ sole obligation hereunder shall be limited to repair, replacement or refund of the purchase price, at Inova Lab’s option. However, this Limited Warranty shall not exclude or limit (1) Purchaser’s statutory righ ts under the applicable national laws, or (2) Purchaser’s rights against the authorized distributor or vendor.

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 distributor at Purchaser’s expense. A prior obtained Return Authorization Number issued by Inova Labs (USA) or its authorized distributor must properly identify returned items together with proof of purchase date. Items returned withou t a Return Authorization Number shall be refused and returned to Purchaser at Purchaser’s expense. Inova Labs shall pay for regular shipment back to Purchaser for repair or replacement of items under this Limited Warranty.

Purchaser shall notify Inova Labs or its authorized distributor of the alleged defect within a reasonable time of discovery of the issue and in any event no later than prior to the expiry of the Limited Warranty coverage.

When repairing or replacing the item Inova Labs may use func tionally equivalent products or parts that are new, equivalent to new or re

- conditioned.

Customer is responsible for proper packaging of all returned items. Any product damage caused by improper packaging will not be covered under warranty repair. Warran ty does not include shipping to Inova Labs for
repair.

As far as national laws permit, the warranty coverage will not be extended or renewed or otherwise affected due to Inova Labs’ authorized repair or replacement. However, part(s) repaired or replacem ent product will be warranted for the unexpired portion of the original Limited Warranty or for sixty (60) days from the date of repair or replacement, whichever is longer.

NO REPRESENTATIVE OF INOVA LABS HAS AUTHORITY TO MAKE ANY REPRESENTATIONS OR

PROMISES EXCEPT AS STATED HEREIN. THIS LIMITED WARRANTY IS EXCLUSIVE AND GIVEN AND
ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A

PARTICULAR PURPO SE AND NON

- INFRINGEMENT. INOVA LABS SHALL HAVE NO FURTHER LIABILITY
FOR ANY DAMAGE, LOSS, COST OR FEE OF WHATEVER KIND OR NATURE, WHETHER FORSEEABLE OR NOT, INCLUDING BUT NOT LIMITED TO ATTORNEYS’ FEES, CONSEQUENTIAL, GENERAL, SPECIAL,

INCIDENTAL, INDIREC T, EXEMPLARY OR PUNITIVE DAMAGES, REGARDLESS OF THE FORM OF THE
CLAIM, WHETHER IN CONTRACT, TORT OR OTHERWISE, ARISING OUT OF OR RELATING TO INOVA LABS’ PRODUCTS, AND EVEN IF INOVA LABS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH

DAMAGES, LOSSES, COSTS OR FEES. TO THE EXTENT PERMITTED BY APPLICABLE LAW, INOVA LABS’

LIABILITY HEREUNDER OR RELATING HERETO SHALL NOT EXCEED THE PURCHASE PRICE PAID FOR
THE PRODUCT, REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM
IS BASED ON CONTRACT, TORT OR OTHERWISE. PURCHASER AGREES AND ACKNOWLEDGES THAT
THE PRODUCT IS OF A SIZE, DESIGN AND CAPACITY SELECTED BY ITS MEDICAL PROVIDER. NO

AGREEMENT VARYING OR EXTENDING THIS LIMITED WARRANTY SHALL BE BINDING UPON INOVA
LABS UNLESS IN WRITING, SIGNED BY A DU LY AUTHORIZED REPRESENTATIVE OF INOVA LABS.

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, Purc haser 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 st atutory 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 . EACH PARTY EXPRESSLY WAIVES ALL RIGHTS T O A TRIAL BY JURY.LifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 18 Technical Support Please contact the local medical equipment company that provided or sold the LifeChoice ActivoxTM P OC to you for any technical or emergency support.

If any additional information is needed, please contact Inova Labs’ Customer Care Manager at

1.800.220.0977 USALifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 19 ACCESSORIES ( ADDITIONAL/REPLACEME NT/SPARE )

Product Number: XYC105 B Description: Standard carry case for LifeChoice Activox POC comes complete with strap system that allows case to be used as a backpack , shoulder strap, waist strap or carried as a briefcase (Included with purchase of LifeChoice Activox POC.)

Product Number: XYC102 B Description: 4

- hour external battery. Extended time battery for more mobility. (Not

included with the STANDARD PACKAGE purchase of the LifeChoice Activox POC

. )

Product Number: TBD Description: External Battery charger module ( Not included with the STANDARD PACKAGE purchase of the LifeChoice Activox POC

. )

Product Number: TBD Description: Extended Life

- External battery pack ( Not included with the STANDARD PACKAGE purchase of the LifeChoice Activox POC

. )

Product Number: XYC283S B Description: Extra small waist belt strap for external battery pack. ( Not included with the STANDARD PACKAGE purchase of the LifeChoice Activo x POC

. )

Product Number: XYC103AC 10’ (3m)
Description: AC Adapter/Charger . Used to charge and run the LifeChoice Activox POC simultaneously . Used at home or in the car, RV, motor boat, etc. (Included with purchase of

LifeChoice Activox POC.)*

Product Nu mber: XYC104DC 6’ (1.8m)
Description: DC Adapter/Charger . Used to charge and run the LifeChoice Activox POC simultaneously. Used at home or in the car, RV, motor boat, etc. (Included with purchase of

LifeChoice Activox POC.)*

Product Number: XYC262

Descri ption: 7’(2.1m) standard single lumen cannula. (Included with purchase of

LifeChoice Activox POC.) ϯ

Product Number: XYC340 B Description: Accessory Bag

* Accessories, adapters, and cables other than those specificed, with the exception of adapters and cables sold by the manufacturer of the medical electrical equipment as replacement parts for internal components, may result in increased emissions or decreased immunity of the Model XYC100

ϯ Cannula may not be included in XYC100 packages in all countries based on local international requirementsLifeChoice Activox Operator’s Manual

XYC276B REV A Jul 2012 20 DISPOSAL

Inova Labs expects end users to dispose of LifeChoice Activox POC in an environmentally friendly way. Electrical and electronic equipment is label with the crossed out wheeled bin symbol indicating that the equipment should be disposed of by the end user separate from other types of waste. The LifeChoice Activox POC device contains lithium

- ion batteries, and 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 main 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 effects on it if they do.

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