LifeChojce 

"'inovaLabs 

.o -.:-^-o 

Docket Management Facility 

US Department of Transportation 

1200 New Jersey Avenue, SE 

West Building Ground Floor 

RoomW12-140 

Washington, DC 20590 :;:; -,-oS ' 

Applicant: — rf-'-OO 

William R. Wilkinson , ", "-'••-

Vice President of Engineenng ~o 

International Biophysics Corporation / Inova Labs, Inc. 

2101 East St. ElmoRd. 

Suite 275 

Austin, TX 78744 

bilKajibcbiO-Com 

Phone:(512)326-3244 

FAX: (512) 326-3299 

Mobile: (512) 466 7214 

Re: Petition for Exemption from Rulemaking 

January 21, 2011 

Dear Sir or Madam, 

Please accept this letter as petition for exemption to the Federal Aviation Administration's (FAA) Special 

Federal Regulation (SFAR) No. 106 under 14 CFR 121 that allows the use of certain portable oxygen 

concentrator (POC) devices on board passenger aircraft. Specifically, we are requesting that the FAA 

amend Section 2 and Section 3 (a) of SFAR No. 106 by changing the manufacturer's name of the 

previously approved LifeChoice Portable Oxygen Concentrator from "International Biophysics 

Corporation" to "(nova Labs, Inc." 

As stated in the previous petition (reference [Docket No. FAA-2004-185963 SFAR 106] Rin 2120-A181), 

the LifeChoice product was launched with Inova Labs as the distributor and International Biophysics 

Corporation as the exclusive manufacturer. A copy of the previously accepted petition is included for your 

reference. Inova Labs owned the technology and had licensed it to International Biophysics Corporation 

for manufacture. The sole change is that Inova Labs has replaced International Biophysics Corporation 

as manufacturer. The LifeChoice device and associated product documentation remains unchanged, the 

device will continue to be manufactured in the same facility in Austin, Texas, and the management 

remains substantially the same. The change in manufacturer name will not affect the letters previously 

provided to the manufacturer by PHMSA and the FDA affirming the status of each device as it pertains to 

the requisites stated in SFAR 106. 

Inova Labs Inc. | 2101 E. St. F.lmo Road. Suite 275 • Austin . Texa s 78744 

P 5 12-326-3237 j P 5 12-326-3299 

LifeChoiceOxvgeii.com 
LifeChojce 

**'Inova Labs 

We do not believe that the requested name change will constitute a "significant regulatory action" as 

defined in section 3(f) of Executive Order 12866, nor be considered "significant" as defined in DOT'S 

Regulatory Policies and Procedures. We therefore respectfully request that the FAA to grant an 

exemption to Section 2 and Section 3 (a) of SFAR No. 106 by allowing a manufacturer's name change for 

the previously approved LifeChoice Portable Oxygen Concentrator from International Biophysics 

Corporation to Inova Labs, Inc. 

Should you need additional information or have any questions regarding this petition, please feel free to 

contact me in any manner convenient for you. I have included my current contact information below for 

your convenience. 

Respectfully submitted, 

William R. Wilkinson 

Vice President of Engineering 

International Biophysics Corporation / Inova Labs, Inc. 

2101 EastSL ElmoRd. 

Suite 275 

Austin, TX 78744 

bill@ibcbio.com 

Phone: (512)326-3244 

FAX: (512)326-3299 

Mobile: (512) 466 7214 

Inova Labs Inc. | 2101 E. St. Elmo Road. Suite 275 | Austin. Texas 78744 

P 512-326-3237 | I- 512-326-3299 

LifeChoiccOxvgen.coni 
ATTACHMENT 

Copy of International Biophysics Corporation/ Inova Labs, LLC Petition 

Docket No. FAA-2004-185963 SFAR 106 Rin 2120-A181 
IBC lateraationa l Biophysic s C o r p o r a t i a n 

January 28, 2009 

U.S. Department of Transportation 

Docket Operations 

West Building, Ground Floor 

Room W12-140 

1200 New Jersey Avenue, SE 

Washington, DC 20590 

m 

CO 

• 1 T 

:z> — -

P 512.326.3244 

F 512.326.3299 

www.IBCbio.coni 

II Eos(St. ElmoRd 

Suite 275 

Austin, TX 78744 

Applicant: -::^.-; 

William R. Wilkinson ' _• f:i 

Vice President of Engineering V^ 

International Biophysics Corporation • ' 

2101 East St. Elmo Road 

Suite 275 

Austin, TX 78744 

bill@ibcbio.com 

Phone: (512) 326-3244 Ext. 110 

Fax:(512)326-3299 

Mobile: (512)466-7214 

Re: Petition to Amend SFAR No. 106 on Portable Oxygen Concentrator Devices on 

Passenger Aircraft 

Dear Sir or Madam: 

SiHCt 1V«2, 

Inlrniationiil 

CorfiomUan 'iiis 

manujaciurtd 

' ami mrjicul 

/BC IS /iroHi^/y 

crrtifitJas ISO 900i 

and /SO fita 5 

Please accept this letter as petition to amend the Federal Aviation Administration's 

(FAA) Special Federal Aviation Regulation (SFAR) No. 106 under 14 CFR 121 that 

allows for the use of certain portable oxygen concentrator (POC) devices on board 

passenger aircraft, [nternational Biophysics Corporation (IBC) is specifically requesting 

that the FAA amend Section 2 and Section 3(a) of SFAR No. 106 by adding the 

LifeChoice Portable Oxygen Concentrator manufactured by IBC and distributed by Inova 

Labs, LLC as one of the approved POC devices for use on passenger aircraft. 

Background 

IBC manufactures medical devices including life support devices used in open heart 

surgery and many other critical medical applications. IBC is the manufacturer of the 

LifeChoice Portable Oxygen Concentrator. The LifeChoice is a very small, lightweight, 

battery powered POC intended for patients with respiratory disorders that require the use 

of supplemental oxygen. At a weight of less than 5 pounds, the LifeChoice is half the size 

of other POC devices and requires no cart. This makes the device ideal for those patients 

who wish to retain the quality of life that comes with improved mobility. 7he ability to 

travel on passenger aircraft is a very important part of that lifestyle. In fact, true mobility 

was the driving force behind the development of the LifeChoice. With no cart and its 

very small size, it has the portability of an average woman's purse. As such, it is a vast 

^ 
r^ 

improvement for airline travel over previous POC devices. No more carts in the aisle or 

devices too bulky to fit under the seat. LifeChoice can be carried on and off the plane like 

a purse and it will not only fit under the seat and in the overhead bin of the smallest 

regional jets, but it can also fit into and operate from inside most seal back pockets. Not 

only will the traveling public with supplemental oxygen requirements benefit from 

LifeChoice, but also the airlines and their fellow passengers. 

LifeChoice provides oxygen by separating oxygen from ambient air utilizing a molecular 

sieve and pressure swing adsorption methodology. The resultant concentrated oxygen is 

accumulated in an oxygen reservoir for delivery to the patient. The LifeChoice dehvers 

oxygen to the patient through the pulse delivery method for maximum effectiveness and 

operational time. This means that a sensor in the LifeChoice detects the inhalation of the 

patient and delivers the oxygen in a bolus at that time. If no breathe is detected because 

the patient takes the cannula off, no oxygen is delivered. Similarly, no oxygen is 

delivered during exhalation which minimizes the waste of oxygen. This feature of 

delivering oxygen on demand also minimizes accumulation of concentrated oxygen in the 

vicinity of the device. 

FDA 510(k) Approval Letter 

On September 19, 2007, IBC submitted an application for written determination of 

substantial equivalence under section 510(k) of the Food Drug and Cosmetic act to The 

U.S. Food and Drug Administration. On January 3, 2008, FDA issued a written 

determination that LifeChoice is substantially equivalent in safety and effectiveness to a 

device that is currently on the market. (See Exhibit A) This predicate device is the Inogen 

One Oxygen Concentrator, a device that the FAA has already granted permission for use 

on passenger aircraft through amendment of SF.AR 106. Through this written 

determination by FDA, the LifeChoice may be marketed to persons requiring 

supplemental oxygen. This approval includes both portable and stationary use, an 

important improvement for the traveling public. 

PHMSA Letter of Interpretation 

On October 13, 2008, IBC submitted a letter to the Pipeline and Hazardous Materials 

Safety Administration requesting a written interpretation that the LifeChoice POC is not 

subject to the U.S. Hazardous Materials Regulation (HMR) as referenced in 49 CFR Parts 

100-180. On January 8, 2009, IBC received confirmation from PHMSA that the 

LifeChoice POC is not subject to the HMR. (See Exhibit B) 

Power Source for the LifeChoice 

The LifeChoice is powered by an internally captive lithium ion battery pack that is not 

removable or replaceable by the end user. It may also be powered by an external AC to 

DC power adapter, an external DC to DC power adapter or an external auxiliary lithium 

ion battery pack. This allows for maximum operating time through the use of different 

power sources. Recharging the internal or external battery packs requires the use of the 
external AC to DC Power Adapter or the external DC to DC Power Adapter supplied for 

the LifeChoice by Inova Labs. Both the internal and the external battery packs meet the 

HMR exemption requirement. 

Owner's Manual 

The owner's manual as contained in the FDA 510(k) submission is attached as exhibit C 

and the proposed amendment is a separate page as shown below. This amended Owner's 

Manual is identical to the original except that it contains this page for persons using the 

LifeChoice POC while traveling on passenger aircraft. 

Instructions for Using IBC LifeChoice Onboard Commercial Passenger Aircraft 

1. The user must have a written statement, to be kept in that person's possession, 

signed by a licensed physician that states whether oxygen use is necessary for all 

or a portion of the duration of the flight, and the required flow rate of oxygen. 

2. The user of the LifeChoice must inform the operator of the aircraft, the pilot in 

command and the flight crew that the LifeChoice POC will be used during the 

flight. 

3. If the LifeChoice is not used during take-off or Landing or during ground 

operations, it must be stored in the overhead compartment or under the seat in 

front of you. 

4. Users of the LifeChoice are prohibited from silting in any exit row or seat that 

may be detrimental to safety in an emergency as determined by a uniformed crew 

member. 

5. Users of the LifeChoice POC must be able to see and hear all alarms of the device 

and respond to them appropriately or travel with a companion who can. 

6. The user of the LifeChoice POC is responsible for the condition of the device and 

must ensure it is free of any petroleum products. 

7. The user of the LifeChoice must ensure that all lotions or salves applied to his/her 

person are oxygen approved. 

8. The user of the LifeChoice POC must carry sufficient batteries to power the 

LifeChoice POC throughout the duration of the flight including a reasonable 

estimate of any unanticipated delays. 

9. The user of the LifeChoice POC must ensure that the external auxiliary battery 

modules carried on board the aircraft in carry on baggage are packed in such a 

way to protect from short circuits, from generating excessive heat and are 

protected from physical damage. 

10. When the LifeChoice is not in use, the external auxiliary battery pack must be 

disconnected and packed separately to prevent accidental operation of the device. 

11. The user of the LifeChoice POC must ensure that there is no open flame or 

smoking within 10 feet of the seat row where he/she is sitting. 

r 
Summary 

IBC believes the information contained in this petition provides sufficient information for 

the FAA to determine that the LifeChoice POC is safe lo be carried and used onboard 

passenger aircraft. We therefore request that Section 2 and Section 3(a) of SFAR No. 106 

be amended by adding the LifeChoice as an approved POC device for use onboard 

passenger aircraft. 

Should you need additional information or have any questions regarding this product, 

please feel free to contact me in any manner convenient for you. I have my cell phone 

with me at all times and can get e-mail through it so that will be quickest whether through 

voice or e-mail. I have included my current information below as well as the website for 

this product should you wish to learn more about it. 

Respectfully submitted. 

^L/\\AnA^_^ 

William R. Wilkinson 

Vice President of Engineering 

International Biophysics Corporation 

2101 East St. Elmo Road 

Suite 275 

Austin, Texas 78744 

Phone:(512)326-3244 

Fax:(512)326-3299 

Cell: (512)466-7214 

E-mail: billt'g^ihcbio.com 

Web site : hitp://www.]ifechoiceoxv£;en.com 

^ 
EXHIBIT A 

r 

FDA 5I0(k) Approval Letter 
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Food and Drug Administration 

9200 Corporate Boulavanj 

Rockville MO 208S0 

JAN 1 i 2008 

Mr. David Shockley 

President 

International Biophysics Corporation 

2101 East St. Elmo Road, Suite 275 

Austin. Texas 78744 

r 

Re: K072688 

Trade/Device Name; International Biophysics Corporation LifeChoice 

Oxygen Concentrator 

Regulation Number: 21 CFR 868.5440 

Regulation Name: Portable Oxygen Generator 

Regulatory Class: II 

Product Code: CAW 

Dated: January 3. 2008 

Received: January 3, 2008 

Dear Mr. Shockley: 

We have reviewed your Section 510(k) premarket notification of intent to market the device 

referenced above and have determined the device is substantially equivalent (for the 

indications for use stated in the enclosure! to legally marketed predicate devices marketed in 

interstate commerce prior to May 28. 19~6. the enactment date of the Medical Device 

Amendments, or to devices that have been reclassified in accordance with the provisions of 

the Federal Food. Drug, and Cosmetic Aa (Act) that do not require approval of a premarket 

appro'/al application (P.M.A.). \ ou ma\'. therefore, market tliC device, subject to the general 

controls provisions of the Act. The general controls provisions of the Act include 

requirements for annual registration, lifting of devices, good manufacturing practice, 

labeling, and prohibitions against misbra:iding and adulteration. 

If your device is ciassiFied (see above) ir.:o either class II (Special Controls) or class 111 

(PMA), it may be subject to such additio:ijl controls, hxisting major regulations affecting 

your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In 

addition. FDA may publish further announcements concerning your device in the Federal 

Register. 
Page 2 - Mr. Shockley 

Please be advised that FDA's issuance of a substantial equivalence determination does not 

mean that FDA has made a determination that your device complies with other requirements 

of the Act or any Federal statutes and regulations administered by other Federal agencies. 

You must comply with all the Act's requirements, including, but not limited to: registration 

and listing (21 CFR Part 807); labeling (21 CFR Pan 801); good inanufaciuTing practice 

requirements as set forth in the quality systems (QS) regulation (21 CFR Pan 820); and if 

applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 

21 CFK 1000-1050. 

This letter will allow you to begin marketing your device as described in your Section 510(k) 

premarket notification. The FDA finding of substantial equivalence of your device to a 

legally marketed predicate device results in a classification for your device and thus, permits 

your device to proceed to the market. 

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 

please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation 

entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You 

may obtain other general information on your responsibilities under the Act from the 

Division of Small Manufacturers, International and Consumer Assistance at its toll-free 

number (800) 638-2041 or (240) 276-3150 or at its Internet address 

ht[p://www.fda,gov/cdrh/industrv/support/jndex.himl. 

Sincerely yours, 

Chiu Lin. Ph.D. 

Director 

Division of Anesthesiology. General Hospital, 

Infection Control and Dental Devices 

Office of Device Evaluation 

Center for Devices and 

Radiological Health 

Enclosure 
EXHIBIT B 

PMHS A Letter of Interpretation 
& 

U.S. tVp»rtineni 1200 ^^^ jo^ty An.. SE 

of Tmwpoiwton WMtMgton. DC 20S90 

Safety AdnWnitir.tion JA N 0 8 2003 

Mr. William R. WiUdnson 

Vice President of Engineering 

iDtematfonai Biophysics Corporation (IBC) 

2100 East St. Elmo Rd. 

Austin, TX 78744 

Rcf. No. 08-0266 

Dear Mr. Wilkinson: 

This is in respoDse to your October 13,2008 letter reganfing the applicability of the Hazardous 

Materials RcguUtions (HMR; 49 CFR Parts 100-180) to a device your company calls the 

LifeChoice Portable Oxygen Concentrator (POC). 

You state in your letter and a subsequent conversation with a niembcr of my staff that the 

UfcChoice POC is a lightweight device thai separates nitrogen from room air through the pressure 

swing absorption (PSA) process and stores the resultant concentrated oxygen gas for delivery (o 

patients requiring supplemental oxygen. This device delivers the oxygen to the patient through the 

pulse dose delivery method. The maximum internally attainable pressure during the PSA cycle of 

^he device is 22 psig (36.7 psia) over an operating temperature range of 5 "C to 40 *C (41 ' F to 104 

•F), with a maximum oxygen accumulator quantity of 45 mil per minute for operation in the pulse 

mode. The device can be powered by multiple power sources, including an internally captive, 

rechargeable lithium ion battery pack, AC to DC power adaptor, by an external DC to DC power 

adapter, or an external accessory lithium ion battery pack. The internally captive lithium ion battery 

consists of 8 rechargeable 2.2 amp-hour lithium ion cells with 0.3 grams of lithium content each, or 

a total of 5.2 grams of total cquivaleni lithium content (0.3 x 2 ^ Ah x 8 cells), and no other 

hazardous materials. The external accessory battery module consists of two battery packs, each 

conuining a total of 5,2 grams of total equivalent lithium content, or a total of 10.4 grams of total 

equivalent lithium content. The lithium ion batten- pack has been tested pursuant to the United 

Nations Manual of Tests and Criteria and is packaged in a manner to prevent short circuits when 

offered for transport or carried onboard passenger aircraft. You ask whether this device is regulated 

as a hazardous material under the HMR. 

Based on the information provided, the LifeChoice POC is not currently subject to the HMR 

because it meets the following criteria: 

1. The pressure of the oxygen in the device does not exceed 280 kPa (40-6 psia) at 20 *C 

(68 -F); 

2. The lithium ion batteries used to operate the device are excepted in the HMR; 
3. The portable oxygen concentrator contains no other materials subject to the HMR; and 

4. The battery pack is packaged in a manner to preclude it from creating sparks or generating a 

dangerous quantity of beat (for example, by the effective insulation of exposed terminals). 

You should also note Federal Aviation Administration (FAA) approval is required before these 

clcctn>nic devices are used by passengers on board airaafL The FAA published a final rule in the 

Federal Register regarding these devices on July 12,2005 (70 FR 40156). For further assistance, 

you may contact Mr. Dave Caiey. Aviation Safety Inspector for the FAA Air Carrier Operations 

Branch (AFS-220) by phone at (202)-267-3732 or email at david.caicv<a'faa.gov. 

In addition, even with FAA approval the air carrier ultimately determines what may or may not be 

earned on its aircraft We suggest that you check with the air carrier lo ensure that the UfeChoice 

portable oxygen concentiator may be caxricd. 

I hope this satisfies your inquiry. If we can be of further assistance, please conuct us. 

Sincere! 

HaUie L. Mitchell 

Chief, Regulatory Review and Reinvention 

Office of Hazardous Materials Standards 
EXHIBIT C 

LifeCho9ice Owner's Manual 

r 
r 

LifeCho.ice® ^ 

•.-am • -Sfc, 

^^rfM^ 

I P ' 

•p.-

\, ^ 

IipeCho2ice® OlJfygen Concentrator 

Owner's Manual 

www.Lifechoiceoxygeri.com 

Version 1.0 
LifeChozice® Oxygen Concentrator Instructions for Use 

INTRODUCTION 

This Patient Manual will familiarize you with the LifeChoice Portable Oxygen 

Concentrator and its accessories. Be sure to thoroughly read all of the 

information in this manual in its entirety. 

APPLICA TION ,.^|,S\ y ife % k 

This manual applies to t|ie'LifeCh.oic^pOjrtable o^gQr\c(j;icentrator. 

INTENDED USE: Jhe LifeQhoice Oxygen Cpnceritrat05,isvused on a prescriptive 

basis by patien^ >*ho are diagnosed as. remjiring lupplemental oxygen. This 

oxygen concentrator will provide supiDleraei^i;fpt^W^ to 

these patients^ It'isnot life supporting^tffoflrfe sustaining, [t ipa^ be* used 

continuously in a home, ins^tutipRTir travel enviropnient V ' ^ 

. .. 

CAUTION: Federal law restfi^tslthis^Ievice to sale by pi>^o^ the order of a 

physician. ^ t ^ '* • ^ ^ - '• 

WARNING: Av'StJability of a*n alterriate source of oxyger^ is required in case of 

power outage or mechanical failure, Cqnsq.lt your physician or medical 

equipment supplier for typfe of ba'ck-'tip system required. ^ -. '^ * ' 

NOTE: It is the responsibility of the patient and/or.provider to make back-up 

arrangements for alternalive.oxygen supply when traveling; Life Choice assumes 

no liability for persons choosing not.to adhere to manufacture^ recommendations. 

' ' • ^ ", \ " . ' • \ •'i •: 

WARNING: This device is'NOT INTENDED to be life sustatning pr life 

supporting. •?.'>' - "' ^ . 

CAUTION: Thisdeyice should be used only, when prescribed by a physician. 

CAUTION: Additional monitoring or attention may be required for patients using 

this device who are unable to hear or see alarms or coni^municate discomfort. If 

the patient shows any signs of discomfort, a physician should be consulted 

immediately. 

CAUTION: The LifeChoice is designed to provide a flow of high purity oxygen. 

Patients with a fast breathing rate, requiring high oj^ygen flow, may require more 

oxygen then the LifeChoice can produce, and therefore may not be suited for the 

LifeChoice. 
GENERAL PRECAUTIONS: 

WARNING: The device produces enriched oxygen gas which accelerates 

combustion. DO NOT ALLOW SMOKING OR OPEN FLAMES within 10 feet of 

this device while in use. 

WARNING: Do not submerse the LifeChoice or any of the accessories in liquid. 

Do not expose to water or precipitation. Do not operate in rain. This could lead to 

damage. , ^ "•, -'•• >, \^ . 

* IK, :i . 

CAUTION: Do not use oil, grease, or-petrpleyjn-based proqiucts on or near the 

LifeChoice. 

USER CO^ROLS .^ ^ \ V x ' ^^^ ^ \ 

CAUTION: The user controls on ^jie LifeChbice^^re specifically designed to be 

pressed by %fingeV. Neverpress any*of the buttonswith a pen, screwdriver, 

stylus, or any-pt^flr object. =• • "••* \'\^ • 

's 

NOTE: Pressing the buttons witl^t any hard, sharp and/or smaill object can 

damage the user control? android all warran{ies. > % •. "^ 

INDICATOR LIGHTS: Colored li^jitsJndicate either.a phange in opei^ating status 

or a condition that may nped resp6nsev(alarm). ' S \ 

AUDIBLE SIGNALS: An audible signal (beep) indicates eithej; a change in 

operating status or a condition that may need response (alarm).' 

GROSS PARflCLE FILTER: Verify that the filter mesh is in- place inside the 

intake slots on tftefent and back of-the poncentrator during operation to keep 

large particles and debrl^.^out of the ihpufair. See Section "Air Intake Filter 

Cleaning" for cleantn^ instructions.' ' t- ' .^ • 

CANNULA NOZZLE FITTING: The nasal cannula connects;to the oxygen output 

nozzle at the top of the LifeChoice. 'It iS:recommended to use a standard, single 

lumen nasal cannula (which is up to 7.foot long) from your local medical supplier. 

WARNING: Do not use power supplies/adapters or accessories other than those 

which come with the LifeChoice. The use of non-specified accessories may 

impair equipment performance and will void all warranties 

^ 
NASAL CANNULA: A standard nasal cannula or equivalent must be used with 

the LifeChoice to provide oxygen from the concentrator. A standard single lumen 

type cannula, seven feet in length or (ess, is recommended to use. 

The LifeCho2ice Mobility Package (XYC100) includes: 

• LifeChoice Portable Oxygen Concentrator 

• Carry Bag:.The carry bag provides a protective outer cover and shoulder 

strap to enable you to caggjjt^ % system c§n^&operated using AC 

power, DC power, or tJattery fjgw^r during trapsport while inside the 

approved carrybag. ' * :.. ••'^* '• ' ^ * 

power^ord (universal 100v -^40y ; 50Hz - 60hz) 

pov^er dprd (12v) wijh ^i^j^&3Bp!*'ear ^ 

• One sUuidard single lumen^T'q^sal ca^ f I 

' • k • ''• • ^ 

% 

OPERATING INSTRUCTIONS 

Locate and position the LifeChoice 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. 

Power the unit from the internal battery, DC outlet,'AC outlet, or the optional 

extended life extertialbattery. 

If you are in an automobile (boat, niotorhome, etc.) connect one end of the 

DC power supply into the LifeChoice power inlet and the other end into the 

DC outlet; or . - , 

If you are near an AC outlet, connect one end of the AC power supply into 

the LifeChoice power inlet and the other end into the AC outlet; or 

Connect one end of the optional extended life external battery pack into 

the LifeChoice power inlet 

Connect your cannula securely to the oxygen outlet. 
POWER BUTTON: Press once to turn "ON", an audible beep will occur and the 

green LED light above the Power button. Active button and Pulse Setting of 1 

button will illuminate once the LifeChoice is ready to operate in less than 2 

minutes. This indicates that LifeChoice is powered on, ready for use and settings 

may now be changed 

ACTIVE and SLEEP MODE: (Inhalation Sensitivity Setting) 

Press the Active button for normal inhal^tiop sensitivity used during normal 

activity/use. Pres^ the Sleep tjUjtpj^lc •qpr^^^ inhalation sensitivity used 

durin ig sleep or when resting.''T?h6Qse.,th resjing^''T;h"o<^e.,Jtie mhalatid in'lia'laVidn settinltinqg. which best suits 

your individual needs.,^ Sleep nriode nrjay^ot-wofk for all. '6erUiin shallow 

breathers and "mpcith" breathers mgy find theyine^d.cpntinuous"oxygen as 

opposed to pufei^nhalation:- Con'sult^ypuc pli^sS^ian cpr^erjflrig ^^^ sleep issues 

and needs. t \ v-%, 

*L\ ^ .••• • ''^.' ^ • •" . \ \\\^ -

FLOW SETTING^ONTRGlJ- BUTTONS!jhere-are|s|hree rhdivrdu^I qulse flow 

buttons on tffe control pariet: ,1 lEi|nri^2 Ipm\pd 3.1p^=^^^ arrioupt'Is 

equivalent vi^ulse). Press tKe d'^ired'flowisettini,a\^jjescribea^^^^ doctor. 

The green L^E^a^ove the Dipon se.Iected illumjn'gfes e(ndiw|jr*^Iinkeach time 

inhalation is detected and a pljls'&pf oxyben^jsdelivejred. ^ ' \ \ ,. 

To change the pulse flow^etting^-press t|]ie ^desired/Ipvv'getting button. The 

green LED light will illum[nate abo'Jp the selected setting "• \ • 

To turn the LifeChoice off, pres!^ the Power buttoh^ahd hold f6^2vseconds until 

the green LED above thef Power button goes off arid the,ijnit''shuts off. 

'•'t. 

When the LifeChoice senses inhalation,-pxygen-is supplied:tq you through your 

cannula. TheBlir^on of this puIsV^flow and size of the^pulsels dependent upon 

the pulse flow s^in g button selected. '• \ • \ \ 

> . , ""•".- - / -,., > .• '^ • '- r ' 

• . • •^." > „ f"-.- •> •' •• • 

POWE R SUPPLIES : LifeChoice cap be powered in four different ways -

the internal battery, an AC power^upply, a DC power supply or using the 

optional extended life e)fternal battery . •'>. 

INTERNAL BATTERY: A rechacgeabife internal battery is located within each 

LifeChoice unit. When it is fully charged it supplies power to the Life Choice unit 

for up to 2+ hours. When operating using internal battery power, the green LED 

above the Battery Check button will illuminate and blink slowly. 

NOTE: The internal battery will slowly discharge over time even when not 

in use. Always check the battery level prior to use to ensure adequate 

charge level. 
BATTERY LEVEL CHECK: Check to make sure your unit's battery is fully 

charged before venturing out with LifeChoice for the first time or upon 

subsequent use. To check the level of charge of the internal battery, press the 

Battery Check button on the LifeChoice control panel. The battery 

gauge/indicator(s) LED's next to the Battery Check button will illuminate to 

indicate the level of battery charge (25% to 100%). 

BATTERY CHARGING: To charge the internal battery, connect Life Choice to 

either an AC Power supply and a 100-240,volt, 5Q/60 Hz AC power outlet, or 

connect it to a DCpt»wer outl§iJ^"j9n;^3^jrnQbile.^^ home, etc.). It 

takes approximately 2 tp^+iours for"a^iiscHarged battery to fully charge. It is 

recommended to recharge the bgtt^ ^ ^Veteif onlif^,psfitially d^*f^^ as often as 

possible. When fully charged, all four LED'awill illunijnate. when the Battery 

Check button is;gressed. '^ - ' ^ -.^ '% \ ^. . %- \ ^ ^ . 

AC POWER Sq f PLY: An AC powep^fS^y^lo ^ tlje LifeCRfeiee tg pe 

connected to aVlOp-240 voIt,%g/6lJ Hz ouJUefc^ The poWi: Sypply coajfehs 100-

240 volt AC to;a DC voltage^pr'^tbe LifeQh'qjce unit. ^yVrien the unitjs^erated 

with the AC poyv^tjsupply, tto^erfromtf^ AC outletpfejwers the^uoitJand 

recharges theJnternal batte^ simultaneously: '% ''\ \ . ^^ \ ' 

DC POWER SUPPLY: A D© ppwer siipplv can be coriqe^ted frpm^th^, 

LifeChoice unit to an automobile's (b^at, motor*bon;[e, etc^te-yolt pC'outlet. 

When the system is connecteS^o the autb^obile's/vehipl^s DC oiitJet,^power 

from the automobile/vehicle t(atter>^Rpw^rs-the)E!j.if^Choice,upit.^ recharges the 

internal battery simultaneously. , '% ' .. \ , ''' ., \ i "^ 

ALARMS/LIGHT INDIC;^QRS: \ ' V 

v . •>, •^•' H • '^ •>. " " \ 

START-UP: Aijrief audible beep sounds at start-up when the Power button is 

pushed. ^ - V:: \ ^ ^ ^ ' 

LOW BATTERY:/Cs the^battery power'^approacj^es a low leVel (less than 10 

minutesof battery power remaining), the Green LED llght.rTiB)^tto the Battery 

Check button turns "Red and flashes slowly. There'is also an alidible long, loud 

beep that will sound once every 60; seconds. ^iA/he^ this ogcurs, connect the 

LifeChoice to a DC powpr outlet, ari AGtpower outlet;^the optional extended life 

external battery, or change to another source ofoxygen. 

When there is approximately 30 seconds of battery power remaining, the red 

slowly flashing I.ED next to the Battery Check light will begin flashing quickly and 

a constant audible alarm will sound. When this occurs, connect the LifeChoice 

into a DC power outlet, an AC power outlet, the optional extended life external 

battery, or change to another source of oxygen immediately 
When the LifeChoice is connected to DC power outlet or to an AC power outlet, 

the unit operates while recharging the internal battery simultaneously. The level 

of battery charge is indicated by the battery gauge/indicator(s) meter when the 

Battery Check light is pressed 

NO INHALATION/NO BREATH: When the LifeChoice is powered on, but does 

not sense breathing within a predetermined time period, approximately 60 

seconds, an audible alarm beeps every 1 second, and the red alami light blinks. 

If this occurs, check the connection frorTLthe|i;armula to the LifeChoice, make 

sure that the nasal cannula ^^^^^^)^^pjj^^^:.9 p i^ogr face, and ensure that 

you are breathing iHrougfj^yiSUr nose.,^nce The ^vstem defects a breath, the 

alarm will autonriaticallyTurn off. I| fh^t^r^ ' dbntlnueS'to spunb, change to an 

alternate source pLpxygen, and coritact your eguipmentjprovid^. 

GENERAL M^I^UNCTION; Jf tn | Uflc^ig^^ ^ 

continuous au<Jip!e|alarm s^hdfl' " •• " - .,. _ 

illuminated. A^Jgen.this occijrs,ith 

supplying is Qptside of specificatiOjns: 

oxygen and ^ntact your equipnrjent 

unction, a 

iht iff c5qtiau<jjjisiy 

mjratipn (Jf c&y'^^ th^t yifeC^jbice is 

'olfshouldchaqge t^angther^source of 

rovider '•''•{• ^ t- , f- •'• 

I f • ^ 

NORMAL OPERATION INPICAipRS ^ 

Normal Operation AUdiblajAlarrn # "^ Ligl f -

Brief audible tonj. 

Light- ^- Action 

LifeChoice 

turned on 

JjPower Button, 

.JLCtl\{^ Button and 

ifPulse Setting of.^ 

Burfbn ^ 9 GREEN^ 

,a'nd. illuminated ,' 

f i . ^• 

Youmay Jjegin to use your 

; LifeChoice Unit 

LifeChoice has._^ 

detected an "zf .;, 

Inhalation/breath and ' 

is delivering a pulse c^ 

oxygen 

No 

Selected ^ulse . 

Sehing Button ^ghf 

j-isQREENand^ 

blinks with eacjjbreath 

UileChoice is functioning 

;* • normally 

•A 

r 
ALARM TAB LE 

Problem Audible Alarm Light Action 

No breath 

detected by the 

unit for 

approximately 

60 seconds 

Intermittent: 

Beep, beep, beep 

RED Alarm button 

light blinks 

Check the cannula connection. 

Ensure that you are breathing 

through your nose. Once the 

system detects a breath, the alarm 

will shut off. If the alarm persists, 

contact your Equipment Provider 

Low Battery 

Indicator 

(Less than 10 

minutes of battery 

power) h 

' Single,,loGd, 

long, b'eep every 

-3 

60 seconds 

~t 

rr 

Critical Low T;; 

Battery Alarm '\_ 

(Approximately 30^ 

seconds of batt^^ry 

power) if ' 

Constant audible 

, beep '•?. 

Battery Check 

••VBuB^nj^hf tuhns 

REu and flashes 

.sloiS;tyt ;. 

* ••* • 

fe..' X ^' . • 

•BEO Battery Check 

llight button begin? 

~' f] ashing ;quiGkly 

/ 

Connect the LifeChoice unit into 

"*ca.DCioutlet, an AC outlet, or the 

optional extended life ex'.^rnal 

: fetfefji qr change to another 

'.• ^ source^of oxygen. 

—7~1^—'. 

•' RED AlarnT^light 

button continuously 

' ' illuminated 

Vyhen this" occu^ , cpnnect the 

; LifeChoice into a DC power 

.i^outlet, an AC pov^er outlet, the 

'opional extended life external 

battery, or ^ang e to another 

source of owg^n immediately. 

General 

malfunction of the 

LifeChoice 

Contjnupus *'. 

audible alarm. 

'Turn off thg unit. Change to 

anojhffr Source of o/ygen, and 

contact your Efliiipment Provider 

AIR INTAKE FILTER CLEANING: At least on^ time each we^k or more, if the 

gross mesh air filter intakes-appear dirty, use a "Q-tip" type cleaner to clean the 

mesh filter media in the intake slots on the front, and back of th6 unit. Follow 

these steps to properly clean the air intajce filter: :' 

Gently ruiia^.Q-Jip" type cleaner along the intake sjots (front and back of 

unit) to cle'an^n^'remove any debris from thejnt^ke filter mesh. Do not 

poke or gouge th^ mesh filter, just gently rub the "Q-tip" cleaner along the 

intake slot areas. 

While not required or recommended, you may wipe the oijtside surface of the 

LifeChoice with isopropyl (99% or less) alcohol as an outer surface cleaning 

method if desired. 

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 a power outage. During a power outage, alarm condition, 

or mechanical failure, use your reserve oxygen supply, and consult your 

Equipment Provider immediately. 
LifeChoice by Inova Labs Limited 3 Year Warranty: 

Limited Warranty: 

Inova Labs, LLC (Inova Labs) warrants that each new LifeChoice Oxygen Concentrator shall be 

free from defects in materials and parts under normal use and operation, and when correctly 

maintained for three years. Any LifeChoice accessories are warranted for one year. Any and all 

batteries for the LifeChoice are warranied for 1 Yr 

Purchaser agrees to ogeratc the P{pd#ct^^5coiTMic(^i^tff'ih*LifeChoice operating manual 

instructions as provided and^hat failure to d(Step,;shall^^oid,lhis*li5iitsd. warranty. Each item of 

equipment for which "warranty claim is asserteS snSHi)e returned on a'prepaid basis with proof of 

purchase date to Ihov^Ijabs, properly pajikaged 

will be responsibl^for all return freight 

identified by a R^nv^jLuthorizationW 

Return Authori^amn-plumber witi be-refiise 

Inova Labs shaltpS' fpr regular ^pmia i 

product under i^a^t^ . 

purchaser. The purchaser 

.musfib^'properly 

d without a 

s expense, 

cements of 

fb; I^niial rottins.scmc otti e items; ippaifbr rep^cement of 

fp, atxid^t, iq^rdper.pia^t^^c ^ abii^e Or -^ 

This limited wa^ari^jdoest not apfjly lb; 

parts/equipmeni^^^sitated by raisu^?, a __,___,__, _ 

repairs/alteratioiifs^g^^e by persons otficr tluji gibra Labp oK.pelsons'^otgexpressly authorized in 

writing prior to any repairs/aItprationsi^y I&jva Labs; dfflecti caused py the efecte of normal 

wear and tear; Acts of God oriother cai;scs«ot within tlScontroI of Inova Labs. ;'-

• i^ •• 1- I -Hi- - H 

The sole and exclusive remed)^or any defeat i§*jirrated'to repair or ,rebl3jeemento£the defective 

part or product, or refund of the purcha|e prfceattht^solf discretion of Iiiov^ t^bs? This limited 

warranty is exclusive and in lieu offill Other, wajjanties or regre^entatioMj eotpressed, or implied, 

either in fact or by operation q^law, statutory or otherwise, rhcluding but not limited to implied 

warranties of merchantability.ifitness for a particular pugios^ and npniinfringement. No 

representation or statement of Inova Labs may change ot^^alter this finiited \vartanty. 

Inova Labs shall hMfcitp further li^ility for datnagcjs, losses; CQ'$t pr fees of any kind or nature, 

whether foreseeablo.or noti'linciudiiig but not liiSited to attorney's fees^aiid consequential, 

general, special, incidentali^^nd^rect, ex,CTnpTary or p\piitifie damage^, regardless of the form of 

any claim, whether in c^nti^c^^tort, offtherwise, ari^g'out of .^r i^Iated to the use of Inova Labs 

products even if Inova Labs hagbeen a"dvised of th^-possibility of sDch daitiages, losses, cost or 

fees. Inova Lab's liability for loss or damages shall; not .exceed theVpurchase price paid for the 

particular product. . ' v ^ ' 

Any claims for breach of (his limited warranty shall be governed by Texas law and must be 

brought in a state or federal court in Texas. 

See our website for more detail www.lifechoiceoxygen.com 
Inova Labs 

2101 E.St. ElmoRd Suite 275 

Austin, TX 78744 

1.512.326.3244 Corp. Office 

1.512.326.3299 Fax 

www.lifechoiceoxygen.com 

ak •=- •.« 

* 'I 

.-!«»•«»« •fH •?^T^-.-

> 

Parts Covered byp Yr Limited warranty. * 

Outer Shell 

Sieve Bed 

Compressors i 

Computer Controller & Power Boards 

PSA Lung Assembly 

Battery-Internal • 

Battery-Extemat/Supplemental 

Accessories 

-i. 

J/' 

J 

" 

•i 

r3yr ^ 

\ " 

X 

X 

X 

• • • 

:; 

1Yr. 

X *-

•^ X 

X 

X 

i 

1 

•i- t-

' t -: 

; Includes touch panel buttons 

Excjjjdes "wef sieve 

-

,1 Year Warranty 

1 Year Warranty 

1 Year Warranty 

All Items are covered"for.Qormal wear and tear^ Any damage cause^ by user neglect or misuse 

will not be covered under the<3 year limited warranty 

Warranty does not include shipping 

n 
n 

LifeChooice® ^ i 

Life^ho2ic^Rortable'Ox^gen^Concentrator 

> Distributed by: ^ - ' 

< • • •. • . • ^ 

^ intpv^lSbs. LLCh | ^ '• i , 

2101 EagtSt Elmo ^d^^Suite 215^^ 

/tusiin, TX 787^4 I 

^ J 512-326-3^44 Corp. 6ffice . 

^-" 512-326-a299 Corp. Fax i ^ 

.•j t , • , ' 

24 Hr Toll Free: 877-490-3339 

iiv^^vw.LifechoiGeoxygeh.com 

Manufaqtured by: 

'Mnternationa! Biophysics Corp. 

Austin, TX 78744 

^^• ^