# LifeChojc e "'inovaLab s

. o -.:-^- o Docke t Managemen t Facilit y U S Departmen t o f Transportatio n 120 0 Ne wJerse yAvenue , S E Wes t Buildin g Groun d Floo r RoomW12-14 0 Washington , D C 2059 0 :;: ; -,-oS ' Applicant : —rf-'-O O Willia m R . Wilkinso n , " , "-'•• - Vic e Presiden t o f Engineenn g ~ o Internationa l Biophysic s Corporatio n / Inov a Labs , Inc . 210 1 Eas t St . ElmoRd . Suit e 27 5 Austin , T X 7874 4 bilKajibcbiO-Co m Phone:(512)326-324 4 FAX : (512 ) 326-329 9 Mobile : (512 ) 46 6 721 4 Re : Petitio n fo rExemptio n fro m Rulemakin g January21 , 201 1 Dea rSi ro rMadam , Pleas e accep t thi s lette ra s petitio n fo rexemptio n t o th e Federa l Aviatio n Administration' s (FAA ) Specia l Federa l Regulatio n (SFAR ) No . 10 6 unde r1 4 CF R 12 1 tha t allow s th e us e o f certai n portabl e oxyge n concentrato r(POC ) device s o n board passenge raircraft . Specifically , w e ar e requestin g tha t th e FAA amen d Sectio n 2 an d Sectio n 3 (a ) o f SFA R No . 10 6 b ychangin g th e manufacturer' s nam e o f th e previousl yapprove d LifeChoic e Portabl e Oxyge n Concentrato rfro m "Internationa l Biophysic s Corporation " t o "(nov a Labs , Inc. " A s state d i n th e previou s petitio n (referenc e [Docke t No . FAA-2004-18596 3 SFA R 106 ] Ri n 2120-A181) , th e LifeChoic e produc t wa s launche d wit h Inov a Lab s a s th e distributo ran d Internationa l Biophysic s Corporatio n a s th e exclusiv e manufacturer . Acop yo f th e previousl yaccepte d petitio n i s include d fo ryou r reference . Inov a Lab s owne d th e technolog yan d ha d license d i t t o Internationa l Biophysic s Corporatio n fo rmanufacture . Th e sol e chang e i s tha t Inov a Lab s ha s replace d Internationa l Biophysic s Corporatio n a s manufacturer . Th e LifeChoic e devic e an d associate d produc t documentatio n remain s unchanged , th e devic e wil l continu e t o b e manufacture d i n th e sam e facilit yi n Austin , Texas , an d th e managemen t remain s substantiall yth e same . Th e chang e i n manufacture rnam e wil l no t affec t th e letter s previousl y provide d t o th e manufacture rb yPHMS Aan d th e FD Aaffirmin g th e statu s o f eac h devic e a s i t pertain s t o th e requisite s state d i n SFA R 106 . Inov aLab s Inc . | 210 1 E . St . F.lm o Road . Suit e 27 5 • Austin . Texa s 7874 4 P 5 12-326-323 7 j P 5 12-326-329 9 LifeChoiceOxvgeii.co m

# LifeChojc e **'Inov a Lab s W e d o no t believ e tha t th e requeste d nam e chang e wil l constitut e a "significan t regulatoryaction " a s define d i n sectio n 3(f ) o f Executiv e Orde r12866 , no rb e considere d "significant " a s define d i n DOT' S RegulatoryPolicie s an d Procedures . W e therefor e respectfull yreques t tha t th e FAAt o gran t a n exemptio n t o Sectio n 2 an d Sectio n 3 (a ) o f SFA R No . 10 6 byallowin g a manufacturer' s nam e chang e fo r th e previousl yapprove d LifeChoic e Portabl e Oxyge n Concentrato rfro m Internationa l Biophysic s Corporatio n t o Inov a Labs , Inc . Shoul d yo u nee d additiona l informatio n o rhav e an yquestion s regardin g thi s petition , pleas e fee l fre e t o contac t m e i n an ymanne rconvenien t fo ryou . I hav e include d m ycurren t contac t informatio n belo wfo r you rconvenience . Respectfull ysubmitted ,

Willia m R . Wilkinso n Vic e Presiden t o f Engineerin g Internationa l Biophysic s Corporatio n / Inov a Labs , Inc . 210 1 EastS L ElmoRd . Suit e 27 5 Austin , TX 7874 4 bill@ibcbio.co m Phone : (512)326-324 4 FAX : (512)326-329 9 Mobile : (512 ) 46 6 721 4

Inov aLab s Inc . | 210 1 E . St . Elm o Road . Suit e 27 5 | Austin . Texa s 7874 4 P 512-326-323 7 | I- 512-326-329 9 LifeChoiccOxvgen.con i

### ATTACHMEN T

Cop yo f Internationa l Biophysic s Corporation / Inov a Labs , LL C Petitio n Docke t No . FAA-2004-185963 SFA R 10 6 Ri n 2120-A18 1

# IB C lateraationa l Biophysic s C o r p o r at i a n Januar y 28 , 200 9 U.S . Departmen t

o f Transportatio n Docke t Operation s Wes t Building , Groun dFloo r Roo mW12-14 0 120 0 Ne w Jerse y Avenue , S E Washington , D C 2059 0 m C O

• 1 T :z > — -

P 512.326.324 4 F 512.326.329 9 www.IBCbio.con i I I Eos(St . ElmoR d Suit e 27 5 Austin , T X7874 4 Applicant : -::^.- ;

Willia mR . Wilkinso n ' _ • f: i Vic e Presiden t

o f Engineerin g V ^ Internationa l Biophysic s Corporatio n • ' 210 1 Eas t

St . Elm o Roa d Suit e 27 5 Austin , T X 7874 4 bill@ibcbio.co m Phone : (512 ) 326-324 4 Ext . 11 0 Fax:(512)326-329 9 Mobile : (512)466-721 4 Re : Petitio n t o Amen dSFA RNo . 10 6 o n Portabl e Oxyge n Concentrato r Device s o n Passenge r

Aircraft Dea r Si r o r Madam :

SiHC t 1V«2 , Inlrniationii l CorfiomUa

n 'iii s manujaciurt d

' am i mrjicu l /B C I S /iroHi^/ y crrtifitJa s IS O 900 i an d/S O fita 5 Pleas e accep t thi s lette r

a s petitio n t o amen dth e Federa l Aviatio n Administration' s (FAA ) Specia l Federa l Aviatio n Regulatio n (SFAR ) No . 10 6 unde r 1 4 CF R12 1 tha

t allow s for

th e us e o f

certai n portabl e oxyge n concentrato r (POC ) device s on boar d passenge r

aircraft , [nternationa l Biophysic s Corporatio n (IBC ) i s specificall y requestin g tha t th e FA A amen dSectio n 2 an dSectio n 3(a ) o f SFA RNo . 10 6 b y addin g th e LifeChoic e Portabl e Oxyge n Concentrato r manufacture db y IB C an ddistribute dby Inov a Labs , LL C a s on e o f

th e approve dPO C device s fo r us e o n passenge r

aircraft . Backgroun d IB C manufacture s medica l device s includin g lif e suppor t

device s use di n ope n heart surger y an dman y othe r critica l medica l applications . IB C i s th e manufacture r o f th e LifeChoic e Portabl e Oxyge n Concentrator . Th e LifeChoic e i s avery small , lightweight , batter y powere dPO C intende dfor patient s wit hrespirator y disorder s that requir e th e us e o f supplementa l oxygen . A t aweigh t o f les s tha n 5 pounds , th e LifeChoic e i s hal f th e siz e o f othe r PO C device s an drequire s n o cart . Thi s make s th e devic e idea l for thos e patient s wh o wis ht o retai n th e qualit y o f lif e that come s wit himprove dmobility . 7h e abilit y t o trave l o n passenge r

aircraf t i s avery importan t

par t o f tha t lifestyle . I

n fact , tru e mobilit y wa s th e drivin g forc e behin dth e developmen t o f th e LifeChoice . Withn o cart an dit s very smal l size , i t

ha s th e portabilit y o f

an averag e woman' s purse . A s such , it i s avas t

^

# r ^ improvemen t fo r airlin e trave l ove r

previou s PO C devices . N o mor e cart s i n th e aisl e o r device s to o bulk y t o fit

unde r th e seat . LifeChoic e ca n b e carrie do n an dof f th e plan e lik e apurs e an dit

wil l no t onl y fit unde r th e sea t an di n th e overhea dbi n o f th e smalles t regiona l jets , bu t

i t ca n als o fit

int o an doperat e fro minsid e mos t sea l bac k

pockets . No t onl y wil l th e travelin g publi c wit hsupplementa l oxyge n requirement s benefi t from LifeChoice , bu t

als o th e airline s an dthei r fello w passengers . LifeChoic e provide s oxyge n b y separatin g oxyge n fro mambien t ai r utilizin g amolecula r siev e an dpressur e swin g adsorptio n methodology . Th e resultan t concentrate doxyge n i s accumulate di n a n oxyge n reservoi r fo r deliver y t o th e patient . Th e LifeChoic e dehver s oxyge n t o th e patien t

throug hth e puls e deliver y metho dfo r maximu meffectivenes s an d operationa l time . Thi s mean s tha t asenso r i n th e LifeChoic e detect s th e inhalatio n o f th e patien t an ddeliver s th e oxyge n i n abolu s at tha t time . I f n o breath e i s detecte dbecaus e th e patien t

take s th e cannul aoff , n o oxyge n i s delivered . Similarly , n o oxyge n i s delivere ddurin g exhalatio n whic hminimize s th e wast e o f oxygen . Thi s featur e o f deliverin g oxyge n o n deman dals o minimize s accumulatio n o f concentrate doxyge n i n th e vicinit y o f

th e device . FD A 510(k ) Approva l Lette r O n Septembe r

19 , 2007 , IB C submitte da n applicatio n for writte n determinatio n o f substantia l equivalenc e unde r sectio n 510(k ) o f

th e Foo dDru g an dCosmeti c ac t t o Th e U.S . Foo dan dDru g Administration . O n Januar y 3 , 2008 , FD A issue dawritte n determinatio n tha t

LifeChoic e i s substantiall y equivalen t i n safety an deffectivenes s t o a devic e tha t

i s currentl y o n th e market . (Se e Exhibi t A ) Thi s predicat e devic e i s th e Inoge n On e Oxyge n Concentrator , adevic e tha t th e FA A ha s alread y grante dpermissio n fo r us e o n passenge r

aircraf t throug hamendmen t

o f SF.A R106 . Throug hthi s writte n determinatio n b y FDA , th e LifeChoic e ma y b e markete dt o person s requirin g supplementa l oxygen . Thi s approva l include s bot hportabl e an dstationar y use , a n importan t improvemen t

fo r th e travelin g public . PHMS A Lette r

o f Interpretatio n O n Octobe r

13 , 2008 , IB C submitte dalette r t o th e Pipelin e an dHazardou s Material s Safety Administratio n requestin g awritte n interpretatio n tha t th e LifeChoic e PO C i s no t subjec t t o th e U.S . Hazardou s Material s Regulatio n (HMR ) a s reference di n 4 9 CF RPart s 100-180 . O n Januar y 8 , 2009 , IB C receive dconfirmatio n fro mPHMS A that th e LifeChoic e PO C i s no t

subjec t t o th e HMR . (Se e Exhibi t B ) Powe r Sourc e fo r

th e LifeChoic e Th e LifeChoic e i s powere db y an internall y captiv e lithiu mio n batter y pac k tha t i s no t removabl e o r

replaceabl e b y th e en duser . I t ma y als o b e powere db y a n externa l A C t o D C powe r

adapter , a n externa l D C t o D C powe r adapte r o r a n externa l auxiliar y lithiu m io n batter y pack . Thi s allow s for maximu moperatin g tim e throug hth e us e o f differen t powe r sources . Rechargin g th e interna l o r externa l batter y pack s require s th e us e o f th e

### externa l A C to D C Powe

r Adapter or the externa

l D C to D C Power

Adapter supplie dfo

r th e LifeChoic e b

y Inov aLabs . Bot

hthe interna

l an dth e external batter

y pack s mee

t the HM Rexemptio n requirement . Owner' s Manua l The owner' s manua

l a s containe di

n the FDA 510(k) submissio n i s attache das exhibit C andthe propose damendment i s aseparate pag e a s show n below . Thi s amende dOwner' s Manua l i s identical t o the original excep t tha t i t contain s thi s pag e fo

r person s usin g the LifeChoic e PO C whil e travelin g o n passenger

aircraft . Instruction s fo r

Usin g IB C LifeChoic e Onboar dCommercia l Passenge r Aircraf t 1 . The use

r mus t hav e awritte n statement , to b e kep t i n tha t person' s possession , signe dby alicense dphysician tha t state s whether

oxyge n us e i s necessar

y fo r all or aportio n of

the duratio n o f

the flight , an

dthe require dflow rat e o f oxygen . 2 . Th e use

r o f th e LifeChoic e mus t

infor mth e operato r

o f th e aircraft , the pilo t

i n commandan

dthe flight

cre w tha t the LifeChoic e PO C will b e useddurin g the flight . 3 . I f the LifeChoic e i s not

useddurin g take-of

f or Landin g or

durin g ground operations , i

t mus t b e store di

n the overheadcompartment o r under the sea t i n fron t o f you . 4 . User s o f

the LifeChoic e ar

e prohibite dfro

msiltin g i

n any exi t

ro w or sea t tha t ma y b e detrimental t

o safet y i n a n emergenc y as determine db y auniformedcre

w member . 5 . User s o f

the LifeChoic e PO C mus t b e abl e t o see an dhea r all alarm s of

the devic e andrespondto themappropriatel y or travel wit hacompanio n who can . 6 . The user

o f the LifeChoic e PO C i s responsibl e fo r the conditio n o f

the devic e an

d mus t ensure i t i s free o f an y petroleumproducts . 7 . Th e user o f th e LifeChoic e mus t

ensur e tha t all lotion s o r

salve s applie dto his/he

r perso n are oxygen approved . 8 . The use

r o f the LifeChoic e PO C mus t carr y sufficien

t batterie s to powe

r the LifeChoic e PO C throughou t th e duratio n o f

th e fligh t includin g areasonabl e estimate o f

an y unanticipate ddelays . 9 . The use

r o f the LifeChoic e PO C mus t ensure tha

t th e external auxiliar

y batter y module s carrie do

n boar dth e aircraf

t i n carr y on baggag e are packe di n suc ha wa y to protec t

fro mshor t circuits , fro

mgeneratin g excessiv e hea t an dar e protecte dfro

mphysica

l damage . 10 . Whe n the LifeChoic e i s not

i n use , the externa

l auxiliar y batter y pack must b e disconnecte dan

dpacke dseparately t

o prevent accidental operatio n o f

the device . 11 . Th e user o f the LifeChoic e PO C mus t ensure tha

t there i s n

o open flam

e or smokin g withi n 1 0 fee

t of the sea t ro w where he/sh e i s sitting . 

# r

### Summar y

IB C believe s th e informatio n containe di n thi s petitio n provide s sufficien t informatio n fo

r the FA A t o determin e tha

t th e LifeChoic e PO C i s saf e lo b e carrie dan dusedonboar d passenge r aircraft . W

e therefore reques t

tha t Sectio n 2 an

dSectio n 3(a) o f

SFA RNo . 106 b e amende db y addin g th e LifeChoic e a s a n approve dPO C devic e fo r us e onboar

d passenge r aircraft . Shoul dyou nee dadditional informatio n or hav e an y question s regardin g thi s product , pleas e fee l fre e to contac t

m e i n an y manne r convenient

fo r you . I hav e m

y cell phone wit hm e a t al l time s an

dca n ge t e-mail throughi

t s o tha t will b e quickes t

whether through voic e or e-mail . I hav e include dm y current informatio n belo w a s well a s the websit e fo r thi s produc t

shoul dyo

u wishto lear

n mor e about it . Respectfully submitted . 

## ^L/\\AnA^_ ^ Willia mR . Wilkinso n Vic e President

o f Engineerin g Internationa

l Biophysic s Corporatio n 210 1 Eas t St . Elmo Roa

d Suit e 27 5 Austin , Texa s 78744 Phone:(512)326-324 4 Fax:(512)326-329 9 Cell : (512)466-721 4 E-mail : billt'g^ihcbio.co

m We b site : hitp://www.]ifechoiceoxv£;en.co m

^

# EXHIBI T A

r FD A 5I0(k ) Approva l Lette rDEPARTMEN T O FHEALT H & HUMA N SERVICE S Publi cHealt h Servic e Foo d an d Dru g Administratio n 920 0 Corporat e Boulavan j Rockvill e M O 208S 0 JA N 1 i 200 8 Mr . Davi dShockle y Presiden t Internationa l Biophysic s Corporatio n 210 1 Eas t

St . Elm o Road , Suit e 27 5 Austin . Texa s 7874 4



# r Re : K07268 8

Trade/Devic e Name ; Internationa l Biophysic s Corporatio n LifeChoic e

Oxyge n Concentrato r Regulatio n Number : 2 1 CF R868.544 0 Regulatio n Name : Portabl e Oxyge n Generato r Regulator y Class : I

I Produc t Code : CA W Dated : Januar y 3 . 200 8 Received : Januar y 3 , 200 8 Dea r Mr . Shockley : W e hav e reviewe dyou r

Sectio n 510(k ) premarke t notificatio n o f

inten t t o marke t

th e devic e referencedabov e an dhav e determine dth e devic e i s substantiall y equivalen t (fo r th e indication s fo r

us e state di n th e enclosure ! t o legall y markete dpredicat e device s markete di n interstat e commerc e prio r t o Ma y 28 . 19~6 . th e enactmen t dat e o f th e Medica l Devic e Amendments , o r

t o device s tha t

hav e bee n reclassifie di n accordanc e withth e provision s o f th e Federa l Food . Drug , an dCosmeti c A a(Act ) that d o no t requir e approva l o f

apremarke t appro'/a l applicatio n (P.M.A.) . \o u ma\' . therefore , marke t tli C device , subjec t

t o th e genera l control s provision s o f

th e Act . Th e genera l control s provision s o f th e Ac t includ e requirement s for

annua l registration , liftin g of devices , goo dmanufacturin g practice , labeling , an dprohibition s agains t misbra:idin g an dadulteration . I f you r devic e i s ciassiFie d(se e above ) ir.: o eithe r clas s I I (Specia l Controls ) o r

clas s 11 1 (PMA) , i t may b e subjec t

t o suc hadditio:ij l controls , hxistin g majo r regulation s affectin g you r devic e ca n b e foun di

n th e Cod e o f

Federal Regulations , Titl e 21 . Part s 80 0 t o 898 . I n addition . FD A may publis hfurthe r announcement s concernin g you r devic e i n th e Federa l Register .Pag e 2 - Mr . Shockle y Pleas e b e advise dtha t

FDA' s issuanc e o f

asubstantia l equivalenc e determinatio n doe s no t mea n tha t FD A ha s mad e adeterminatio n that you r devic e complie s wit hothe r requirement s o f th e Ac t o r an y Federa l statute s an dregulation s administere db y othe r Federa l agencies . Yo u mus t compl y wit hal l th e Act' s requirements , including , bu t no t limite dto : registratio n an dlistin g (2 1 CF RPar t 807) ; labelin g (2 1 CF RPa n 801) ; goo dinanufaciuTin g practic e requirement s a s se t

forthi n th e qualit y system s (QS ) regulatio n (2 1 CF RPa n 820) ; an di f applicable , th e electroni c produc t radiatio n contro l provision s (Section s 53 1 -54 2 o f th e Act) ; 2 1 CF K 1000-1050 . Thi s lette r

wil l allo w yo u t o begi n marketin g you r devic e a s describe di n you r Sectio n 510(k ) premarke t

notification . Th e FD A finding o f substantia l equivalenc e o f you r devic e t o a legall y markete dpredicat e devic e result s i n aclassificatio n fo r you r devic e an dthus , permit s you r devic e t o procee dt o th e market . I f yo u desir e specifi c advic e fo r you r devic e o n ou r

labelin g regulatio n (2 1 CF RPar t 801) , pleas e contac t

th e Offic e o f

Complianc e a

t (240 ) 276-0115 . Also , pleas e not e th e regulatio n entitled . "Misbrandin g b y referenc e t o premarke t notification " (21CF RPart 807.97) . Yo u may obtai n othe r

genera l informatio n o n you r responsibilitie s unde r

th e Ac t fro mth e Divisio n o f

Smal l Manufacturers , Internationa l an dConsume r Assistanc e a

t it s toll-fre e numbe r (800 ) 638-204 1 o r

(240 ) 276-315 0 o r

a t it s Interne t

addres s ht[p://www.fda,gov/cdrh/industrv/support/jndex.himl . Sincerel y yours , Chi u Lin . Ph.D . Directo r Divisio n o f

Anesthesiology . Genera l Hospital , Infectio n Contro l an dDenta l Device s Offic e o f Devic e Evaluatio n Cente r fo r Device s an d Radiologica l Healt h

Enclosur e

# EXHIBI T B

PMH S A Lette r

o f Interpretatio n& U.S . tVp»rtinen i 120 0 ^^ ^ jo^t yAn. . S E o f Tmwpoiwto n WMtMgton . D C 20S90 Safet yAdnWnitir.tio n JA N 0 8 200 3 Mr . Willia mR . WiUdnso n Vic e President

o f Engineerin g iDtematfona

i Biophysic s Corporatio n (IBC ) 210 0 Eas t St . Elm o Rd . Austin , T X 7874 4 Rcf . No . 08-026 6 Dea r Mr . Wilkinson : Thi s i s i n respoDseto you r Octobe r 13,200 8 letter

reganfing th e applicability o f the Hazardou s Material s RcguUtion s (HMR ; 4 9 CF RPart s 100-180 ) t o adevic e you r compan y call s th e LifeChoic e Portabl e Oxyge n Concentrato r (POC) . Yo u state i n your

lette r an dasubsequen t

conversatio n wit

haniembc r

o f m y staf f tha t the UfcChoic e PO C i s alightweigh t devic e tha i separate s nitroge n fromroo mai r throug hth e pressure swin g absorptio n (PSA ) proces s an dstore s th e resultant concentrate doxyge n ga s fo r deliver y ( o patient s requiring supplemental oxygen . Thi s devic e deliver s th e oxyge n t o the patient throug hthe puls e dos e deliver

y method . Th e maximu minternall y attainabl e pressure durin g the PS A cycl e o f ^h e devic e i s 2 2 psi g (36. 7 psia ) ove r a n operatin g temperature rang e o f 5 " C t o 4 0 * C (41 ' Ft

o 10 4 •F) , wit hamaximu moxyge n accumulato r quantit y o f 4 5 mi l per

minut e for

operatio n i

n th e puls e mode . Th e devic e can b e powere db y multipl e power sources , includin g a

n internall y captive , rechargeabl e lithiu mion battery pack , A C t o D C power adaptor , b y a

n external D C t o D C power adapter , o r

a n external accessory lithiu mio n batter y pack . Th e internall y captiv e lithiu mion batter y consist s o f

8 rechargeabl e 2. 2 amp-hour lithiu mio

n cell s wit h0. 3 gram s of

lithiu mcontent

each , or atota l o f 5. 2 gram s o f

total cquivalen i lithiu mconten t (0. 3 x 2 ^ A

hx 8 cells) , an dn o other hazardou s materials . Th e external accessory batter y modul e consist s of

tw o battery packs , eac h conuinin g atotal o f

5, 2 gram s of

total equivalen t

lithiumcontent , or

atotal o f 10. 4 gram s o f

tota l equivalent lithiu mcontent . The lithiu mio n batten - pack ha s bee n teste dpursuan t

t o th e United Nation s Manua

l o f Test s an dCriteri aan di s package di n amanne r t o prevent shor t circuit s whe

n offere dfo r transpor t o r carrie donboar dpassenge r aircraft . Yo

u as k whethe r thi s devic e i s regulate d as ahazardou s material under the HMR . Basedon the informatio n provided , the LifeChoic e POC i s not currentl y subjec t

t o the HM R becaus e i t meet s th e followin g criteria : 1 . The pressur e o f

the oxyge n i

n the devic e doe s not

excee d28 0 kPa(40- 6 psia ) a t 2 0 * C (6 8 -F) ; 2 . Th e lithiu mion batterie s use dt o operat e the devic e ar e excepte di n the HMR ;3 . Th e portabl e oxyge n concentrato r contain s n o other

material s subjec t

t o th e HMR ; and 4 . Th e batter

y pac k i s package di n amanner

t o preclud e i t

fro mcreatin g sparks o r

generatin g a dangerou s quantity of

bea t (for example , b y the effectiv e insulatio n o f expose dterminals) . Yo u shoul dals o not e Federal Aviatio n Administratio n (FAA ) approval i s require dbefore thes e clcctn>nic device s are use db y passenger s o n boardairaaf LTh e FA A publishe dafinal rul e i n the Federa l Register regardin g thes e device s o n Jul y 12,200 5 (7 0 F R40156) . Fo r

furthe r assistance , yo u ma y contac t Mr . Dav e Caiey . Aviatio n Safet y Inspecto r

for the FAA Ai r

Carrie r Operation s Branch(AFS-220 ) b y phon e at (202)-267-373 2 o r

emai l a t david.caicv<a'faa.gov . I n addition , eve n wit

hFAA approva

l th e ai r carrier ultimatel y determine s wha t may o r ma y no t be earne do n it s aircraf

t We sugges t

tha t yo u chec k

wit hthe ai r carrie r l o ensur e that

th e UfeChoic e portabl e oxyge n concentiato r ma y b e caxricd . I hop e thi s satisfie s you r

inquiry . I

f w e ca n b e o f

furthe r assistance , pleas e conuc t us . Sincere ! HaUi e L . Mitchel l Chief , Regulator

y Revie w andReinventio n Office o f Hazardou s Material s Standard s

# EXHIBI T C

LifeCho9ic e Owner' s Manual

r

# r LifeCho.ice ® ^ •.-a m• -Sfc , ^^rfM ^

I P' •p. - \ , ^ 

# IipeCho2ice ® OlJfyge

n Concentrato r Owner' s Manua l www.Lifechoiceoxygeri.co m

Versio n 1. 0

## LifeChozice ® Oxyge n Concentrato rInstruction s fo rUs e INTRODUCTIO N Thi s Patien t Manua l wil l familiariz e yo u wit h th e LifeChoic e Portabl e Oxyge n Concentrato ran d it s accessories . B e sur e t o thoroughl yrea d al l o f th e informatio n i n thi s manua l i n it s entirety . 

## APPLIC ATIO N ,.^|,S\ yif e % k Thi s manua l applie s t o t|ie'LifeCh.oic^pOjrtabl e o^gQr\c(j;icentrator . INTENDE D USE : Jh e LifeQhoic e Oxyge n Cpnceritrat05,isvuse d o n a prescriptiv e basi s b ypatien ^

>*h o ar e diagnose d as . remjirin g lupplementa l oxygen . Thi s oxyge n concentrato rwil l provid e supiDleraei^i;fpt^W ^ t o thes e patients ^

It'isno t lif e supporting^tffoflrf e sustaining , [ t ipa ^ be * use d continuousl yi n a home , ins^tutipRTi rtrave l enviropnien t V ' ^

. . . CAUTION : Federa l la wrestfi^tslthis^Ievic e t o sal e b ypi>^o ^ th e orde ro f a physician . ^ t ^ ' * • ^ ^ - ' • WARNING : Av'StJabilityo f a* n alterriat e sourc e o f oxyger ^ i s require d i n cas e o f powe routag e o rmechanica l failure , Cqnsq.l t you rphysicia n o rmedica l equipmen t supplie rfo rtypf e o f ba'ck-'ti p syste m required . ^ - . ' ^ * ' NOTE : I t i s th e responsibilit yo f th e patien t and/or.provide rt o mak e back-u p arrangement s fo ralternalive.oxyge n suppl ywhe n traveling ; Lif e Choic e assume s n o liabilit yfo rperson s choosin g not.t o adher e t o manufacture ^ recommendations .

' ' • ^ " , \

" . ' • \ •' i • : WARNING : Thi s devic e is'NO TINTENDE D t o b e lif e sustatnin g p rlif e supporting . •?.'> ' - " ' ^ . CAUTION : Thisdeyic e shoul d b e use d only , whe n prescribe d b ya physician . CAUTION : Additiona l monitorin g o rattentio n ma yb e require d fo rpatient s usin g thi s devic e wh o ar e unabl e t o hea ro rse e alarm s o rconi^municat e discomfort . I f th e patien t show s an ysign s o f discomfort , a physicia n shoul d b e consulte d immediately . CAUTION : Th e LifeChoic e i s designe d t o provid e a flo wo f hig h purit yoxygen . Patient s wit h a fas t breathin g rate , requirin g hig h oj^yge n flow , ma yrequir e mor e oxyge n the n th e LifeChoic e ca n produce , an d therefor e ma yno t b e suite d fo rth e LifeChoice .

## GENERA L PRECAUTIONS : WARNING : Th e devic e produce s enriche d oxyge n ga s whic h accelerate s combustion . D O NO TALLO W SMOKIN G O R OPE N FLAME S withi n 1 0 fee t o f thi s devic e whil e i n use . WARNING : D o no t submers e th e LifeChoic e o ran yo f th e accessorie s i n liquid . D o no t expos e t o wate ro rprecipitation . D o no t operat e i n rain . Thi s coul d lea d t o damage . , ^ "• , -'• • > , \ ^ . * IK , :i . CAUTION : D o no t us e oil , grease , or-petrpleyjn-base d proqiuct s o n o rnea rth e LifeChoice . 

## USE R CO^ROL S . ^ ^ \ V x' ^^^ ^

\ CAUTION : Th e use rcontrol s o n ^ji e LifeChbice^^r e specificall ydesigne d t o b e presse d b y%fingeV . Neverpres s any*o f th e buttonswit h a pen , screwdriver , stylus , o rany-pt^fl robject . = • • "••

* \'\ ^

•

' s NOTE : Pressin g th e button s witl^ t an yhard , shar p and/o rsmail l objec t ca n damag e th e use rcontrol ? androi d al l warran{ies . > % • . " ^ INDICATO R LIGHTS : Colore d li^jitsJndicat e either. a phang e i n opei^atin g statu s o ra conditio n tha t ma ynpe d resp6nsev(alarm) . ' S \ AUDIBL E SIGNALS : A n audibl e signa l (beep ) indicate s eithej ; a chang e i n operatin g statu s o ra conditio n tha t ma ynee d respons e (alarm). ' GROS S PARflCL E FILTER : Verif ytha t th e filte rmes h i s in - plac e insid e th e intak e slot s o n tftefen t an d bac k of-th e poncentrato rdurin g operatio n t o kee p larg e particle s an d debrl^.^ou t o f th e ihpufair . Se e Sectio n "Ai rIntak e Filte r Cleaning " fo rcleantn ^ instructions. ' ' t - ' .

^ • CANNUL ANOZZL E FITTING : Th e nasa l cannul a connects;t o th e oxyge n outpu t nozzl e a t th e to p o f th e LifeChoice . 'I t iS:recommende d t o us e a standard , singl e lume n nasa l cannul a (whic h i s u p t o 7.foo t long ) fro m you rloca l medica l supplier . WARNING : D o no t us e powe rsupplies/adapter s o raccessorie s othe rtha n thos e whic h com e wit h th e LifeChoice . Th e us e o f non-specifie d accessorie s ma y impai requipmen t performanc e an d wil l voi d al l warrantie s ^NASA L CANNULA : Astandar d nasa l cannul a o requivalen t mus t b e use d wit h

th e LifeChoic e t o provid e oxyge n fro m th e concentrator . Astandar d singl e lume n typ e cannula , seve n fee t i n lengt h o r(ess , i s recommende d t o use . Th e LifeCho2ic e Mobilit yPackag e (XYC100 ) includes :

• LifeChoic e Portabl e Oxyge n Concentrato r • Carr yBag:.Th e carr yba g provide s a protectiv e oute rcove ran d shoulde r stra p t o enabl e yo u t o caggjjt ^ % syste m c§n^&operate d usin g A C power , D C power , o rtJatteryfjgw^ rdurin g trapspor t whil e insid e th e approve d carrybag . ' * :. . ••'^ * ' • ' ^

* power^or d (universa l 100 v-^40y ; 50H z - 60hz ) pov^e rdpr d (12v ) wij h ^i^j^&3Bp!*'ear ^ • On e sUuidar d singl e lumen^T'q^sa l ca ^ f I

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## OPERATIN G INSTRUCTION S Locat e an d positio n th e LifeChoic e s o tha t th e ai rinlet s an d ai routlet s ar e no t obstructed . Th e unit , particularl yth e ai rintak e slots^^:an d th e ai routlet s area , shoul d b e locate d i n a well-ventilate d space . Powe rth e uni t fro m th e interna l battery , D C outlet,'A C outlet , o rth e optiona l extende d lif e extertialbattery . I f yo u ar e i n a n automobil e (boat , niotorhome , etc. ) connec t on e en d o f th e D C powe rsuppl yint o th e LifeChoic e powe rinle t an d th e othe ren d int o th e D C outlet ; o r. - , I f yo u ar e nea ra n A C outlet , connec t on e en d o f th e A C powe rsuppl yint o th e LifeChoic e powe rinle t an d th e othe ren d int o th e A C outlet ; o r Connec t on e en d o f th e optiona l extende d lif e externa l batter ypac k int o th e LifeChoic e powe rinle t Connec t you rcannul a securel yt o th e oxyge n outlet .POWE R BUTTON : Pres s onc e t o tur n "ON" , a n audibl e bee p wil l occu ran d th e gree n LE D ligh t abov e th e Powe rbutton . Activ e butto n an d Puls e Settin g o f 1 butto n wil l illuminat e onc e th e LifeChoic e i s read yt o operat e i n les s tha n 2 minutes . Thi s indicate s tha t LifeChoic e i s powere d on , read yfo rus e an d setting s ma yno wb e change d ACTIV E an d SLEE P MODE : (Inhalatio n Sensitivit ySetting ) Pres s th e Activ e butto n fo rnorma l inhal^tio p sensitivit yuse d durin g norma l activity/use . Pres ^

th e Slee p tjUjtpj^l c•qpr^^ ^ inhalatio n sensitivit yuse d durin g slee p o rwhe n resting.''T?h6Qse.,th in'lia'laVid ltinq . i resjing^''T;h"o<^e.,Jti e mhalatid n settin g whic h bes t suit s you rindividua l needs., ^ Slee p nriod e nrjay^ot-wof k fo rall . '6erUii n shallo w breather s an d "mpcith " breather s mg yfin d theyine^d.cpntinuous"oxyge n a s oppose d t o pufei^nhalation: - Con'sult^ypu cpli^sS^ia n cpr^erjflri g ^^ ^ slee p issue s an d needs . t \

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.••• • ''^.' ^ • •" . \ \\\^ - FLO W SETTING^ONTRGlJ - BUTTONS!jhere-are|s|hre e rhdivrdu^ I quls e flo w button s o n tff e contro l pariet : , 1 lEi|nri^ 2 Ipm\p d 3.1p^=^^

^ arrioupt'I s equivalen t vi^ulse) . Pres s tK e d'^ired'flowisettini,a\^jjescribea^^^^ doctor . Th e gree n L^E^a^ov e th e Dipo n se.Iecte d illumjn'gfes e(ndiw|jr*^Iinkeac h tim e inhalatio n i s detecte d an d a pljls'&p f oxyben^jsdelivejred . ^ ' \ \ , . T o chang e th e puls e flow^etting^-pres s t|]i e ^desired/Ipvv'gettin g button . Th e gree n LE D ligh t wil l illum[nat e abo'J p th e selecte d settin g " • \ • T o tur n th e LifeChoic e off , pres! ^ th e Powe rbuttoh^ah d hol d f6^2vsecond s unti l th e gree n LE D abov e the f Powe rbutto n goe s of f ari d the,ijnit''shut s off .

'•'t . Whe n th e LifeChoic e sense s inhalation,-pxygen-i s supplied:t q yo u throug h you r cannula . TheBlir^o n o f thi s puIsV^flo wan d siz e o f the^pulsel s dependen t upo n th e puls e flo ws^in g butto n selected . ' • \ • \ \ > . , ""•".- - / -,. , > . • ' ^ • '- r' • . • •^." > „ f"-. - • > • ' • • • POWE R SUPPLIES : LifeChoic e ca p b e powere d i n fou rdifferen t way s - th e interna l battery , a n A C power^upply , a D C powe rsuppl yo rusin g th e optiona l extende d lif e e)fterna l batter y. •'> . INTERNA L BATTERY : Arechacgeabif e interna l batter yi s locate d withi n eac h LifeChoic e unit . Whe n it i s full ycharge d i t supplie s powe rt o th e Lif e Choic e uni t fo ru p t o 2 + hours . Whe n operatin g usin g interna l batter ypower , th e gree n LE D abov e th e Batter yChec k butto n wil l illuminat e an d blin k slowly . NOTE : Th e interna l batter ywil l slowl ydischarg e ove rtim e eve n whe n no t i n use . Alway s chec k

th e batter yleve l prio rt o us e t o ensur e adequat e charg e level .BATTER YLEVE L CHECK : Chec k t o mak e sur e you runit' s batter yi s full y charge d befor e venturin g ou t wit h LifeChoic e fo rth e firs t tim e o rupo n subsequen t use . T o chec k th e leve l o f charg e o f th e interna l battery , pres s th e Batter yChec k

butto n o n th e LifeChoic e contro l panel . Th e batter y gauge/indicator(s ) LED' s nex t t o th e Batter yChec k butto n wil l illuminat e t o indicat e th e leve l o f batter ycharg e (25 % t o 100%) . BATTER YCHARGING : T o charg e th e interna l battery , connec t Lif e Choic e t o eithe ra n A C Powe rsuppl yan d a 100-240,volt , 5Q/6 0 H z A C powe routlet , o r connec t i t t o a DCpt»we routl§iJ^"j9n;^3^jrnQbile.^ ^ home , etc.) . I t take s approximatel y2 tp^+iour s for"a^iiscHarge d batter yt o full ycharge . I t i s recommende d t o recharg e th e bgtt^ ^ ^Vetei f onlif^,psfitiall yd^*f^ ^ a s ofte n a s possible . Whe n full ycharged , al l fou rLED'awil l illunijnate . whe n th e Batter y Chec k butto n is;gressed . ' ^ - ' ^ -. ^ '% \ ^ . . % - \ ^ ^ . A C POWE R Sq f PLY : A n A C powep^fS^y^lo ^ tlj e LifeCRfeie e t g p e connecte d t o aVlOp-24 0 voIt,%g/6l J H z ouJUefc ^ Th e poWi : Syppl ycoajfeh s 100 - 24 0 vol t A C to; a D C voltage^pr'^tb e LifeQh'qjc e unit . ^yVrie n th e unitjs^erate d wit h th e A C poyv^tjsupply , tto^erfromtf^ A C outletpfejwer s the^uoitJan d recharge s theJnterna l batte ^ simultaneously : '

% '' \ \ . ^

^ \ ' D C POWE R SUPPLY : AD © ppwe rsiippl vca n b e coriqe^te d frpm^th^ , LifeChoic e uni t t o a n automobile' s (b^at , motor*bon;[e , etc^te-yol t pC'outlet . Whe n th e syste m i s connecteS^ o th e autb^obile's/vehipl^ s D C oiitJet,^powe r fro m th e automobile/vehicl e t(atter>^Rpw^rs-the)E!j.if^Choice,upit. ^ recharge s th e interna l batter ysimultaneously . , ' % ' . . \ , '' ' . , \ i " ^ 

## ALARMS/LIGH TINDIC;^QRS : \ ' V

v . •> , •^• ' H • ' ^ •> . " " \ START-UP : Aijrie f audibl e bee p sound s a t start-u p whe n th e Powe rbutto n i s pushed . ^ - V: : \ ^ ^

^ ' LO W BATTERY:/C s the^batter ypower'^approacj^e s a lo wleVe l (les s tha n 1 0 minuteso f batter ypowe rremaining) , th e Gree n LE D llght.rTiB)^tt o th e Batter y Chec k butto n turn s "Re d an d flashe s slowly . There'i s als o a n alidibl e long , lou d bee p tha t wil l soun d onc e ever y60 ; seconds . ^iA/he ^ thi s ogcurs , connec t th e LifeChoic e t o a D C powp routlet , ar i AGtpowe routlet;^th e optiona l extende d lif e externa l battery , o rchang e t o anothe rsourc e ofoxygen . Whe n ther e i s approximatel y3 0 second s o f batter ypowe rremaining , th e re d slowl yflashin g I.E D nex t t o th e Batter yChec k ligh t wil l begi n flashin g quickl yan d a constan t audibl e alar m wil l sound . Whe n thi s occurs , connec t th e LifeChoic e int o a D C powe routlet , a n A C powe routlet , th e optiona l extende d lif e externa l battery , o rchang e t o anothe rsourc e o f oxyge n immediatel yWhe n th e LifeChoic e i s connecte d t o D C powe routle t o rt o a n A C powe routlet ,

th e uni t operate s whil e rechargin g th e interna l batter ysimultaneously . Th e leve l o f batter ycharg e i s indicate d b yth e batter ygauge/indicator(s ) mete rwhe n th e Batter yChec k

ligh t i s presse d N O INHALATION/N O BREATH : Whe n th e LifeChoic e i s powere d on , bu t doe s no t sens e breathin g withi n a predetermine d tim e period , approximatel y6 0 seconds , a n audibl e alar m beep s ever y1 second , an d th e re d alam i ligh t blinks . I f thi s occurs , chec k

th e connectio n frorTLthe|i;armul a t o th e LifeChoice , mak e sur e tha t th e nasa l cannul a ^^^^^^)^^pjj^^^:.9 p i^og rface , an d ensur e tha t yo u ar e breathin g iHrougfj^yiSU rnose.,^nc e Th e ^vste m defect s a breath , th e alar m wil l autonriaticallyTur n off . I | fh^t^r^ ' dbntlnueS't o spunb , chang e t o a n alternat e sourc e pLpxygen , an d coritac t you reguipmentjprovid^ . GENERA L M^I^UNCTION ; J f tn | Uflc^ig^^ ^ 

### continuou s au<Jip!e|alarms^hdfl ' " •• " - ., . _ illuminated . A^Jgen.thi s occijrs,it h supplyin g i s Qptsid e o f specificatiOjns : oxyge n an d ^ntac t you requipnrjen t unction , a 

### ih t iff c5qtiau<jjjisi y mjratip n (J f c&y'^ ^

th^ t yifeC^jbic e i s 'olfshouldchaqg e t^angther^sourc e o f rovide r'•''•{ • ^

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## NORMA L OPERATIO N INPICAipR S ^ Norma l Operatio n AUdiblajAlarr n # " ^ Lig l 

# f - Brie f audibl e tonj . Light - ^ - Actio n LifeChoic e turne d o n JjPowe rButton , .JLCtl\{ ^ Butto n an d ifPuls e Settin g of. ^ Burfb n ^ 9 GREEN ^ ,a'nd . illuminate d , ' f i . ^ • Youma yJjegi n t o us e you r ; LifeChoic e Uni t

LifeChoic e has._

^ detecte d a n "z f .; , Inhalation/breat h an d ' i s deliverin g a puls e c

^ oxyge n N o Selecte d ^uls e .

Sehin g Butto n ^gh f j-isQREENand ^ blink s wit h eacjj breat h UileChoic e i s functionin g

; * • normall y

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### ALAR M TA B L E Proble m Audibl e Alar m Ligh t Actio n N o breat h detecte d b yth e uni t fo r approximatel y 6 0 second s Intermittent :

Beep , beep , bee p RE D Alar m butto n ligh t blink s Chec k th e cannul a connection . Ensur e tha t yo u ar e breathin g throug h you rnose . Onc e th e syste m detect s a breath , th e alar m wil l shu t off . I f th e alar m persists , contact you rEquipmen t Provide r Lo wBatter y Indicato r (Les s tha n 1 0 minute s o f batter y power ) h ' Single,,loGd ,

long , b'ee p ever y - 3 6 0 second s

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t 

## r r Critica l Lo wT; ; Batter yAlar m '\

_ (Approximatel y30^ second s o f batt^^r

y power ) i f ' Constan t audibl e

, bee p '•? . Batter yChec k

••VBuB^nj^h f tuhn s RE u an d flashe s .sloiS;ty t ; .

* ••* • fe..' X ^ ' . • •BE O Batter yChec k lligh t butto n begin ?

~ ' f] ashin g ;quiGkl y / Connec t th e LifeChoic e uni t int o "*ca.DCioutlet , a n A C outlet , o rth e optiona l extende d lif e ex'.^rna l : fetfefji q rchang e t o anothe r '. • ^ source^o f oxygen .



## —7~1^—' . ' • RE D AlarnT^ligh t butto n continuousl y ' ' illuminate d Vyhe n this " occu^ , cpnnec t th e ; LifeChoic e int o a D C powe r .i^outlet , a n A C pov^e routlet , th e 'opiona l extende d lif e externa l battery , o r^ang e t o anothe r sourc e o f owg^ n immediately . Genera l malfunctio n o f th e LifeChoic e Contjnupu s *' .

audibl e alarm . 'Tur n of f th g unit . Chang e t o anojhff rSourc e o f o/ygen , an d contac t you rEfliiipmen t Provide r AI R INTAK E FILTE R CLEANING : A t leas t on ^ tim e eac h we^ k

o rmore , i f th e gros s mes h ai rfilte rintakes-appea rdirty , us e a "Q-tip " typ e cleane rt o clea n th e mes h filte rmedi a i n th e intak e slot s o n th e front , an d bac k o f th 6 unit . Follo w thes e step s t o properl yclea n th e ai rintajc e filter : : ' Gentl yruiia^.Q-Jip " typ e cleane ralon g th e intak e sjot s (fron t an d bac k o f unit ) t o cle'an^n^'remov e an ydebri s fro m thejnt^k e filte rmesh . D o no t pok e o rgoug e th ^

mes h filter , jus t gentl yru b th e "Q-tip " cleane ralon g th e intak e slo t areas . Whil e no t require d o rrecommended , yo u ma ywip e th e oijtsid e surfac e o f th e LifeChoic e wit h isopropy l (99 % o rless ) alcoho l a s a n oute rsurfac e cleanin g metho d i f desired . RESERV E OXYGE N SUPPLY : You rEquipmen t Provide rshoul d provid e o r sugges t a n alternativ e sourc e o f supplementa l oxyge n therap yi n cas e ther e i s a mechanica l failur e o ra powe routage . Durin g a powe routage , alar m condition , o rmechanica l failure , us e you rreserv e oxyge n supply , an d consul t you r Equipmen t Provide rimmediately .

## LifeChoic e b y Inov aLab s Limite d3 Yea r Warranty : Limite dWarranty : Inov aLabs , LL C (Inov aLabs ) warrant s tha t eac hne w LifeChoic e Oxyge n Concentrato r shal l b e free fromdefect s in material s an dpart s unde r norma l us e an doperation , an dwhe n correctl y maintaine dfor

thre e years . An y LifeChoic e accessorie s ar e warrante dfo r on e year . An y an dal l batterie s fo r

th e LifeChoic e ar e warranie dfo r 1 Y r Purchase r

agree s t o ogerat c th e P{pd#ct^^5coiTMic(^i^tff'ih*LifeChoic e operatin g manua l instruction s a s provide dand^ha t failur e t o d(Step,;shall^^oid,lhis*li5iitsd . warranty . Eac hite mo f equipmen t

fo r whic h"warrant

y clai mi s asserte S snSHi) e returne do n a'prepai dbasi s wit hproo f o f purchas e dat e t o Ihov^Ijabs , properl y pajikage d wil l b e responsibl^fo r

al l retur n freight identifie db y aR^nv^jLuthorization W Retur n Authori^amn-plumbe r wit i be-refiis e Inov aLab s shaltpS ' fp r regula r ^pmia i produc t unde r i^a^t^ . purchaser . Th e purchase r .musfib^'properl y

dwithou t a s expense , cement s o f 

### ott i fb ; I^niia l rottins.scmc e items ; ippaifb r rep^cemen t

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t o an y repairs/aItprationsi^ y I&jv aLabs ; dfflect i cause dp y th e efect e o f norma l wea r an dtear ; Act s o f

Go doriothe r

cai;scs«o t

withi n tlScontro I o f

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th e purcha| e prfceattht^sol f discretio n o f

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implied , eithe r in fac t o r b y operatio n q^law , statutor y o r otherwise , rhcludin g bu t no t limite dt o implie d warrantie s o f

merchantability.ifitnes s fo r aparticula r

pugios ^ an dnpniinfringement . N o representatio n o r

statemen t

o f Inov aLab s ma y chang e ot^^alte r thi s finiited\vartanty . Inov aLab s shal l hMfcitp furthe r li^ilit y fo r

datnagcjs , losses ; CQ'$

t p r fee s o f an y kin do r

nature , whethe r foreseeablo.o r

noti'linciudiii g bu t

no t liiSite dt o attorney' s fees^aii dconsequential , general , special , incidentali^^nd^rect , ex,CTnpTar y o r p\piitifi e damage^ , regardles s o f th e for mo f an y claim , whethe r

in c^nti^c^^tort , offtherwise , ari^g'ou t o f .^ r i^Iate dt o th e us e o f

Inov aLab s product s eve n i f

Inov aLab s hagbee n a"dvisedo f th^-possibilit y o f

sDc hdaitiages , losses , cos t o r fees . Inov aLab' s liabilit y fo r los s o r damage s shall ; no t

.excee dtheVpurchas e pric e pai dfo r th e particula r product . . ' v ^ ' An y claim s fo r

breac ho f

(hi s limite dwarrant y shal l b e governe db y Texa s law an dmus t b e brough t in astat e o r

federa l cour t

in Texas .

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mor e detai l www.lifechoiceoxygen.co m

## Inov aLab s 210 1 E.St . ElmoR dSuit

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