# ISEQUAI ! : • • • • ' -T' T,-^ , Th e Smart Choice . •' • " " S(;Qu;i i Technoiogie s inc . 

### Jul y 26 , 201 0 Docke t Managemen t

Facilit y U S Departmen t

o f Transportatio n 120 0 New Jerse y Avenue , S E Wes t Buildin g Groun dFloo r Roo mW12-14 0 Washington , D C 2059 0 Re : Petitio n t o Amen dSFA RNo . 10 6 o n Portabl e Oxyge n Concentrato r Device s on Passenge r Aircraf t Dea r Ms . Deaderick : Pleas e accep t

thi s lette r

a s apetitio n to amen dth e Federal Aviatio n Administration' s (FAA ) Special Federa l Aviatio n Regulatio n (SFAR ) No . 10 6 unde r 1 4 CFR12 1 that

allow s for

th e us e o f

certai n portabl e oxyge n concentrato r (POC ) device s onboar dpassenge r aircraft . W e are specificall y requestin g that

th e FAA amen dth e Sectio n 2 an dSectio n 3(a ) o f SFA RNo . 10 6 b y addin g SeQual Technologies ' SARO S Oxyge n Syste ma s on e o f th e approve dPO C device s fo r us e on passenge r aircraft . Backgroun d SeQual Technologie s Inc . i s amanufacture r o f medical , militar y an dindustria l oxyge n concentrator s an dothe r ai r separatio n equipment . W e currentl y are preparin g t o marke t ou r SARO S Oxyge n System , whic hi s asmall , lightweight , batter y powere dPO C devic e for patient s that

requir e supplementa l oxygen . I

t i s ou r goal t o provid e a

n oxyge n syste mthat

wil l expan dapatient' s ability to trave l viaaircraf

t an dthu s substantiall y improv e thei r quality o f

life . Th e SARO S Oxyge n Syste m Technica l Manua l i s attache da s Exhibi t A . Th e SARO S Oxyge n Syste mseparate s oxyge n fromambien t ai r throug haproces s calle dPressur e Swin g Adsorptio n (PSA) . I t provide s asolutio n t o addres s bothstationary an dportabl e requirement s fo r oxyge n patient s needin g u p t o 3 liter s pe r minut e (LPM ) ful

l flo w operatio n an dup t o 9 6 milli-lite r bolu s i n apuls e flow mod e operation . Th e SARO S Oxyge n Syste machieve s it s performanc e throug h SeQual' s patente dAdvance dTechnolog y Fractionato r (ATF® ) technolog y andpatente dvariabl e spee d compresso r

an dcompresso r

drive , advance dmolecular siev e material s an drechargeabl e batteries . I t provide s US P93 % Medica l Grad e Oxyge n t o b e delivere dto th e patient . Th e Foo dan dDru g Administratio n (FDA ) ha s issue dSeQual Technologie s awritte n determinatio n that th e technolog y use din th e SARO S Oxyge n Syste mi s substantiall y equivalen t t o legall y markete d predicate ddevice s an dthu s i t can b e place do n th e marke t a s aportabl e oxyge n concentrator . (Se e Exhibi t B. ) Th e SARO S Oxyge n Syste mals o i s functionall y similar t o SeQual' s Eclips e Oxyge n Syste man dth e othe r

portabl e oxyge n concentrator s reference din th e FAA' s January 6 , 20 1 Final Rule . (Se e 7 0 Fed . Reg . 40156. )

# I SEQUAL ' Th e Smart Choice , 

### SeQual Reques t

for PHMS A Lette r

o f Interpretatio n O n Jul y 22 , 201 0 SeQual Technologie s submitte dalette r t o th e Pipelin e andHazardou s Material s Safet y Administratio n (PHMSA ) requestin g awritte n interpretatio n that th e SARO S Oxyge n Syste mi s no t subjec t t o th e U.S . hazardou s materia l regulation s (HMR ) pursuan t t o th e requirement s reference d in 4 9 CFR173.115(b)(1 ) for Clas s 2 , Divisio n 2. 2 gase s an d4 9 CFR173.18 5 fo r lithiu mio n batteries . Th e lette r i s attache da s Exhibi t

C . W e expec t

confirmatio n fromPHMS A b y mid-Octobe r that our produc t i s no t subjec t t o th e HMR . Powe r Sourc e for

SARO S Oxvae n Svste m Th e SARO S Oxyge n Syste mi s capabl e o f bein g operate ddirectl y froma n A C o r D C powe r

sourc e o r fromarechargeabl e lithiu mio n battery . I t ca n b e recharge dand/o r

powere db y aseparat e A C Powe r Adapte r o r wher e standar dA C lin e powe r i s available . Th e 2 4 Vol t D C Cabl e an dth e 1 2 Vol t Cabl e accessorie s allo w powe r

t o b e provide db y aD C auxiliary powe r outlet , suc ha s in amoto r vehicl e durin g transportation . Use r changeabl e lithiu mio n batterie s ar e availabl e t o provid e arang e o f ambulatory operationa l time . Th e lithiu mio n battery use dt o powe r th e SARO S Oxyge n Syste m provid e approximatel y 3 0 t o 9 0 minute s o f ru n time , dependin g o n th e flow mod e andsettin g require d b y th e patient . W e are very sensitiv e t o FAA' s concern s withregar dt o passenger s placin g spar e batterie s in thei r carry-o n baggage . W e therefor e designe dabatter y withrecesse dterminal s fo r us e in th e SARO S Oxyge n Syste mt o mee t

th e requirement s containe din Sectio n 3 , provisio n (b)(6 ) o f SFARNo . 106 . Thes e type s o f

terminal s significantl y reduc e th e possibilit y o f externa l short

circuit s fromoccurrin g whe n batterie s ar e carrie donboar daircraft . Ou r Technica l Manual als o wil l contai n detaile d instrucfion s o n th e Federa l regulator y requirement s for carryin g thes e batterie s onboar daircraft . W e wil l instruc t

ou r customer s t o utiliz e th e plasti c ba g (inne r packaging ) an dstron g fiberboardbo x tha t th e batter y i s shippe din whe n carryin g th e battery onboar dt o preven t th e batter y fro

mbein g damaged . Thes e instruction s an dadditional informatio n o n th e saf e transport

o f batterie s als o wil l b e poste do n ou r website . Instruction s for

Passenger s Usin g th e SARO S Oxvge n Svste mOnboar dAircraf t T o mee t th e FAA' s requirement s note di n SFA RNo . 106 , ou r Technica l Manua l andwebsit e wil l contai n th e followin g instruction s for passenger s that

inten dt o us e th e SARO S Oxyge n Syste m onboar daircraft : 1 Th e use r

mus t hav e awritte n statement , t o b e kep t in that person' s possession , signe db y a license dphysicia n statemen t that states : (i ) Whethe r

th e use r o f th e SARO S Oxyge n Syste mha s th e physica l andcognitiv e ability to see , hear , an dunderstan dth e device' s aural andvisual caution s an dwarning s andi s able , withou t assistance , t o tak e th e appropriat e actio n in respons e t o thos e caution s and warnings ; (ii ) Whethe r

o r no t oxyge n us e i s medicall y necessar y for all o r aportio n o f

th e duratio n o f th e trip ; an d (iii ) Th e maximu moxyge n flow rat e correspondin g t o th e pressur e in th e cabi n o f th e aircraf

t unde r norma l operatin g conditions . Pag e 2 of4

# I SEQUAL ' Th e Smar t Choice . 

### 2 . Th e use r

mus t informth e aircraf

t operato r an dcre w that

th e SARO S Oxyge n Syste mma y b e use donboar dth e aircraf

t an dhav e th e physician' s statemen t availabl e that

specifie s th e duratio n o f

oxyge n us e required ; 3 . Durin g movemen t

o n th e surface , takeoff

, an dlanding , th e SARO S Oxyge n Syste mmust : (i ) Eithe r b e stowe dunde r

th e seat i n front o f th e user , o r

in anothe r

approve dstowag e location , s o that i t doe s not bloc k th e aisl e way o r

th e entrywa y int o th e row ; 4 . User s o f

th e SARO S Oxyge n Syste mar e prohibite dfromsittin g i n exi t rows ; 5 . If th e use r o f th e SARO S Oxyge n Syste mi s no t capabl e o f

hearin g th e unit' s alarms , seein g th e alarmligh t

indicators , o r

hav e th e cognitiv e abilit y t o tak e th e appropriat e actio n in respons e t o th e variou s cautio n an dwarnin g alarm s an dalarmlight indicator s the y mus t

b e travelin g withsomeon e wh o i s capabl e o f performin g thos e funcfions ; 6 . Th e use r

mus t ensur e th e SARO S Oxyge n Syste mi s fre e o f oil , greas e o r

othe r petroleu m product s an di s i n goo dconditio n fre e fromdamag e o r othe r sign s o f excessiv e wea

r o r abuse ; 7 . Th e use r

mus t ensur e tha t

al l lotion s or

salve s that

are oxyge n approve dmay b e use db y person s usin g th e SARO S Oxyge n System ; 8 . Th e user , whos e physicia n statemen t specifie s th e duratio n o f oxyge n use , mus t

obtai n from th e aircraf

t operator , o r

b y othe r means , th e duratio n o f

th e planne dflight. Th e use r the n mus t carry o n th e flight asufficient numbe r o f batterie s t o powe r

th e SARO S Oxyge n Syste m for th e duratio n o f

th e oxyge n us e specifie din th e user' s physicia n statement , includin g a conservativ e estimat e o f

an y unanticipate ddelays ; 9 . Th e use r

mus t ensur e that

th e SARO S Oxyge n Syste mbatterie s carrie donboar dth e aircraf t in carry-o n baggag e ar e package din suc hawa y t o preven t short circuit s o r

generatin g a dangerou s quantit y o f

heat an dprotect s the mfromphysica l damage ; and 10 . If th e use r doe s no t inten dt o us e th e SARO S Oxyge n Syste monboar ddurin g th e flight, th e batter y mus t

b e remove dan dpackage dseparatel y t o preven t accidenta l operation . CompUanc e withRTCA/DO-160 E Th e SARO S Oxyge n Syste mha s successfiill y me t testin g pursuan t

t o th e requirement s o f

RTC A /DO 160E , Sectio n 2 1 t o sho w that th e devic e wil l no t

interfer e witha

n aircraft' s electrical , navigation , o r communicatio n equipment . Attache dar e th e dat afromth e RTC A testing . Summarv W e trus t th e informatio n containe di n thi s petitio n i s sufficient for FAA t o detennin e that

th e SARO S Oxyge n Syste mi s saf

e t o b e carrie donboardaircraft . W e therefor e reques t that Sectio n 2 andSectio n 3(a ) o f SFA RNo . 10 6 b e amende db y addin g SeQual Technologies ' SARO S Oxyge n Syste ma s a n approve dPO C devic e for us e onboar daircraft . Shoul dyo u nee dadditional informatio n o r hav e an y question s regardin g ou r product , pleas e d o no t hesitat e t o cal l m e a

t th e contac t

informatio n below . Pag e 3 of4

# ISEQUAL* Th e Smart Choice . 

### Respectfiilly ,

Pamel aJ . Jackso n Senio r Director , Governmen t

an dMilitary SeQual Technologie s Inc . 1143 6 Sorrent o Valle y Roa d San Diego , C A 9212 1 Phone:858-202-314 4 FAX : 858-558-191 5 Cell : 760-805-900 0 Email : pjackson@sequal.co m

Pag e 4 of4EXHIBI TA 

# SAROS TM Oxyge n System , Mode l 300 0 Technica l Manua l

1 o f 8 9

# CONTENT S

GENERA L INFORMATIO N 4 SYSTE M SPECIFICATION S 5 ELECTROMAGNETI C COMPATIBILIT Y8 HO W TH E SYSTE M WORK S 9 THEOR YO F OPERATO N 9 AT F CONCENTRATIO N MODUL E 1 0 COMPRESSO R 1 0 BRUSHLES S COMPRESSO R MOTO R DRIVE R (BCMD ) 1 0 COOLIN G FA N 1 0 POWE R BOAR D 1 0 SYSTE M BOAR D 1 0 CONTRO L PANE L 1 1 CONTINUOU S FLO W MOD E 1 1 PULS E FLO W MOD E WIT H AUTOSA TTECHNOLOG Y1 2 UTILIT YMOD E 1 2 SERVIC E MOD E FUNCTION S 1 2 POWE R SUPPLIE S 1 2 A C POWE R ADAPTE R 1 2 2 4 VOL TD C CABL E 1 3 BATTER Y1 3 CHARGIN G ALGORITH M 1 4 TRAININ G INTRODUCTIO N 1 6 TRAININ G CHECKLIS T1 7 IMPORTAN TSAFET YINSTRUCTION S 1 9 Symbol s use d 1 9 INDICATION S FO R US E 2 1 CONTRAINDICATION S 2 1 SAFET YGUIDELINE S 2 1 Batter ySafet y2 3 INTRODUCTIO N T O YOU R SARO S 2 4 UNDERSTANDIN G TH E CONTROL S o n th e FRON TPANE L 2 5 Descriptio n o f th e SARO S 2 5 Input/Outpu t Connection s 2 7 User-Control s an d Syste m Statu s Indicator s 2 8 Example s o f LC D Displa y2 9 RECOMMENDE D OPERATIN G ENVIRONMENT S 3 1 Th e Prope rLocatio n 3 2 OPERATIN G INSTRUCTION S 3 2 Powerin g O N You rSARO S 3 3 Operatin g You rSARO S 3 7 ALERTS , ALARM S AN D TROUBLESHOOTIN G 4 0 STANDAR D COMPONENT S AN D OPTIONA L ACCESSORIE S 4 3 CLEANING , CAR E AN D ROUTIN E MAINTENANC E 4 4 BATTER YCLEANING , CAR E AN D MAINTENANC E 4 5 INTRODUCTION-SERVIC E AN D REPAI R 4 6 2 o f 8 9PERIODI C MAINTENANC E LIS T4 6

MAITENANC E PROCEDUR E 4 7 TES TPROCEDURE S 5 1 RECOR D HOUR S O F OPERATIO N AN D SOFTWAR E VERSIO N 5 2 ELECTRICA L SAFETYTES T5 3 CLEANIN G TH E SARO S 5 3 SERVIC E AN D MAINTENANC E RECOR D 5 4 SHIPPIN G AN D TRANSPORTIN G TH E SARO S 5 5 STORIN G TH E SARO S 5 5 DISCARDIN G 5 5 ALAR M INDICATION S AN D CODE S 5 6 SERVIC E AN D REPAI R PROCEDURE S 6 0 SYSTE M SCHEMATI C AN D DIAGRAM S 6 1 MAI N COMPONENT S 6 2 REMOV E AN D REPLAC E TH E BATTER YCONNECTO R 6 3 POWE R CONNECTO R REPLACEMEN T7 0 USE R PANE L REPLACEMEN T7 1 REMOV E AN D REPLAC E TH E AT F ASSEMBLY74 MAINTENANC E AN D REPLACEMEN TPART S 8 6 MAUFACTURE D B

Y8 9

3 of 8 9

# Genera l Informatio n

Thi s Technica l Manua l wil l familiariz e yo u wit h informatio n regardin g th e SARO S Oxyge n System , Mode l 3000 . Instruction s i n thi s manua l ar e intende d t o hel p ensur e that : • Users ar e familia rwit h th e SARO S syste m component s an d syste m principle s o f operatio n • Users ar e give n prope rguidanc e i n th e us e of th e SARO S an d it s accessorie s • Users are mad e awar e o f th e care , maintenance , servic e an d repai ro f th e SARO S Oxyge n System . WARNIN G 

# A IMPORTAN TSAFETYINFORMATIO N FO R HAZARD S THA TMIGH TCAUS E

SERIOU S INJURY . CAUTIO N 

# A IMPORTAN TINFORMATIO N FO R PREVENTIN G DAMAG E T O TH E SAROS . D Q NOT ; INFORMATIO N NEEDIN G SPECIA L ATTENTION . IMPORTANT ! CLARIFYIN G INFORMATION , SPECIFI C INSTRUCTIONS , O R USE R REFERENC E

INFORMATION .

4 of 8 9

## SARO S OXYGE N SYSTE M SPECIFICATION S

Oxyge n Concentrato r Dimension s

- Wit h batter y

- Withou t batter y Weigh t

- Wit h Batter y

- Withou t Batter y Flo wSetting s

- Continuou s Flo w

- Puls e flo w Continuou s Flo wAccurac y Oxyge n concentratio n Maximu m Syste m Pressur e Oxyge n Outpu t Pressur e Oxyge n Concentratio n Statu s Indicato r

Nomina l Soun d Leve l Operatin g Environmen t

- Temperatur e

- Humidit y 

### Storag e Environmen t

- Temperatur e

- Humidit y Nomina l Powe r 3 LP M Continuou s Flo w Nomina l Batter yoperatin g tim e a t 3 LP M Continuou s Flo w Continuou s Flo wIndicatio n Audibl e Alar m Indicator s

Back-U p Alar m Powe r Filter s Devic e Classificatio n 26.80 " lon g x4.375 " diamete r 23.25 " lon g x4.375 " diamete r 12.2 5 pound s 10.0 0 pound s -1,2 , 3 LP M -16,32,48,64,80,9 6 m l +/ - 10 % o r20Gml/min , whicheve ri s greate r 93 % +/ - 3 % fo ral l flo wsetting s 1 5 psi g (103. 5 kPa ) 4. 0 psi g (27. 6 kPa ) nomina l Gree n Ligh t = Norma l Operatio n Yello wLigh t Flashin g = Warnin g o rCaution , les s tha n 85 % ± 3 % Re d Ligh t = Abnorma l Operation , les s tha n 70 % ±5 % <5 9 dB(A ) 32°Ft o 109°F(0°to43''C ) 10 % t o 95% , Non-condensing , 82.4° F (28°C ) Maximu m De wpoin t -4 ° F t o 140 ° F (-20 ° t o 60°C ) U p t o 95 % Non-condensin g S I 3 0 Watt s 3 0 Minute s Expresse d i n liter s pe rminut e (LPM ) • Los s o f Power/Ho t Batter y • Lo wBattery/War m Batter y • Lo wOxyge n Outpu t • N o breat h detectio n • 0 2 Flo wOutsid e Norma l Limit s • Lo w9 V batter y • Uni t Malfunctio n 9 V Interna l Batter y Ai rInle t Filter , HEP Aan d Exhaus t Filte r lE C Clas s 1 . Typ e B Applie d Part , IPX 1

5 o f 8 9

### Puls e Mod e Specification s

Puls e Setting s autoSA TTechnolog y Trigge rSensitivit y Trigge rCriteri a Minimu m tim e betwee n breath s Respons e t o Missin g Breath s 16,32,48,64,80,9 6 m l Servo-contro l t o maintai n consisten t Fi0 2 Adjustabl e setting s o f 1 (mos t sensitive) , 2 an d 3 (leas t sensitive ) Cannul a pressur e ha s droppe d belo wth e trigge r poin t (typicall ybetwee n 0.1 5 - 0.4 5 C m o f H2O o f negativ e pressure ) 1.2 5 second s (max . 3 consecutiv e breaths ) Switc h t o Continuou s Mod e i f n o inspiratio n ha s bee n detecte d fo r6 0 second s wit h a n audibl e alarm . 

### Bolu s Volum e an d Breat h Rate s Bolu s Siz e m l ( ±15% )

1 6 3 2 4 8 6 4 8 0 9 6 Ma xBreat h Rat e 4 0 4 0 4 0 4 0 3 7 3 1 NOTE : A t breat h rat e abov e Ma xBreat h Rate , bolu s siz e wil l b e reduce d proportionally . 

### Powe rAccessor ySpecification s A C Powe rAdapte r 2 4 VD C Cabl e Inpu t Voltag e Inpu t Powe r Outpu t Voltag e Outpu t Powe r 100-24 0 VAC , 50-6 0 H z 24 5 - 26 0 V A 2 4 VD C 20 0 W Inpu t Voltag e Inpu t Curren t 2 1 -2 9 VD C 10 A 

### Batter ySpecification s Outpu t Voltag e Capacit y Nomina l Batter yLif e Batter yRecharg e Tim e 14. 8 VD C 8 6 W-hour s 80 % Capacit yafte r20 0 Charge/Discharg e cycle s 2. 4 hour s t o achiev e 80 % capacit yfro m a full ydischarge d batter y

6 o f 8 9

### Independen t Safet yTestin g

SARO S Syste m an d SARO S Concentrator , Mode l 300 0 Safet y Electromagneti cCompatibilit y lE C 60601- 1 :198 8 + A 1 :199 1 + A 2 :199 5 + Corrigendu m (6/95 ) E N 60601-1(1990 ) + A1(1993 ) + A2(1995 ) + A12(1993 ) + A13(1996 ) + Corrigend a (7/94 ) FC C 15 B (Sec . 10 7 & 109) , EN55011 , EN60601-1- 2 :2001 , EN6100 - 3-2 , EN61000-3-3 , IEC61000-4-2 , IEC61000-4-3 , IEC61000-4-4 , IEC61000-4-5 , IEC61000-4-6 , IEC61000-4-8 , IEC61000-4-11 , lE C 60601-1 - 2 :2001 , RTC AD O 16 0 Re vF A C Powe rAdapte r Safet y Electromagneti cCompatibilit y lE C 60601-1:1988 + A1:199 1 +A2:199 5 FC C 15 B (Sec . 10 7 & 109) , EN55011 , EN60601-1- 2 :2001 , EN6100 - 3-2 , EN61000-3-3 , IEC61000-4-2 , IEC61000-4-3 , IEC61000-4-4 , IEC61000-4-5 , IEC61000-4-6 , IEC61000-4-8 , IEC61000-4-11 , EN55014- 1 2 4 VD C Cabl e Safet y Electromagneti cCompatibilit y Portion s o f lE C 60601-1:198 8 + A1:199 1 + A2:199 5 FC C 15 B (Sec . 109) , EN55011 , EN60601-1- 2 :2001 , IEC61000-4-2 , IEC61000-4-3 , IEC61000-4-4 , IEC61000-4-6 , lE C 60601-1- 2 :200 1 Batter y Safet y Electromagneti cCompatibilit y UL2054 , UL60950-1 , Firs t Editio n (U L Fil e MH29443) , lE C 60601 - 1:198 8 + A1:199 1 + A2:1995 , U N Transportatio n Test s T1-T 8 E N 61000-6- 3 :200 1 (EN5502 2 :1998+A 1 :2001+A 2 :2003) , EN61000-6- 1 :2001 , EN61000-4- 2 :1995+A 1 :1998 , EN61000-4- 3 :200 2 An yCSA-CU S mar k

fo rth e SARO S syste m doe s no t encompas s operatio n wit h th e 2 4 VD C Cable .

7 o f 8 9

## ELECTROMAGNETI C COMPATIBILIT Y

Thi s equipmen t complie s wit h th e limit s fo rmedica l device s t o th e IEC60601-1- 2 Electromagneti c Compatibilit yStandard . Thes e limit s ar e designe d t o provid e reasonabl e protectio n agains t harmfu l interferenc e i n a typica l medica l installation . Th e equipmen t generates , use s an d radiate s radi o frequenc yenerg yand , i f no t installe d accordin g wit h th e instructions , ma ycaus e harmfu l interferenc e t o othe rdevice s i n th e vicinity . However , ther e i s n o guarante e tha t interferenc e wil l no t occu ri n a particula r installation . I f thi s equipmen t doe s caus e harmfu l interferenc e t o othe rdevices , whic h ca n b e determine d b yturnin g th e equipmen t of f an d on , th e use ri s encourage d t o tr yt o correc t th e interferenc e b yon e o r mor e o f th e followin g measures : Reorien t o rrelocat e th e receivin g device . Increas e th e separatio n distanc e betwee n th e equipment . Connec t th e equipmen t int o a n outle t o n a circui t differen t fro m tha t whic h th e othe rdevice(s ) ar e connected . Consul t wit h SeQua l Technica l Suppor t fo rhelp . Guidanc e an d Manufacturer' s declaratio n - electromagneti cemission s Th e SeQua l Technologie s SARO S Oxyge n Syste m i s intende d fo rus e i n th e electromagneti c environmen t specifie d below . Th e custome ro rth e use ro f th e SeQua l Technologie s SARO S Oxyge n Syste m shoul d assur e tha t i t i s use d i n suc h a n environment . Emission s Tes t R F emission s E N 5501 1

R F emission s E N 5501 1 Harmoni cemission s lE C 61000 - 3- 2 Voltag e fluctuations /

flicke r emission s lE C 61000-3- 3 Complianc e Grou p 1

Clas s B Clas s A Complie s Electromagneti cenvironmen t

- guidanc e Th e SeQua l Technologie s SARO S Oxyge n Syste m use s R F energ yonl yfo rit s interna l function . Therefore , it s R F emission s ar e ver ylo wan d ar e no t likel yt o caus e an y interferenc e i n nearb yelectroni c equipment . Th e SeQua l Technologie s SARO S Oxyge n Syste m i s suitabl e fo rus e i n al l establishments , includin g domesti cestablishment s an d thos e directl yconnecte d t o th e publi clo w- voltag e powe r suppl ynetwor k

tha t supplie s building s use d fo rdomesti c purposes .

8 o f 8 9

# HOW SARO S WORK S

INTRODUCTIO N Th e SARO S Oxyge n System , Mode l 300 0 wit h autoSAT TM Technolog yi s a portabl e medica l devic e use d t o extrac t oxyge n fro m th e atmosphere , concentrat e i t t o greate rtha n 90 % an d flo wi t throug h th e oxyge n outle t port . Th e devic e wil l operat e i n Continuou s flo wo rPuls e flo wmodes . I n Continuou s Flo wMod e th e oxyge n i s provide d a t a constan t flo wrat e o f 1 , 2 , o r3 LPM . I n Puls e flo wMode , oxyge n i s supplie d i n a bolu s a t th e beginnin g o f eac h inspiration , providin g a selectabl e rang e settin g o f flo wbetwee n 1 6 m l an d 9 6 ml , i n increment s o f 1 6 ml . Asettin g o f 1 6 m l i n Puls e Flo wMod e deliver s th e equivalen t amoun t o f oxyge n a s a continuou s flo wMod e settin g o f 3 LPM . SARO S i s BT P (Body , Temperature , an d Pressure ) compensated . I t deliver s oxyge n b yaccountin g fo r differenc e betwee n ambien t condition s an d thos e foun d i n th e patient' s lung s (37°C) . SARO S operate s fro m externa l power , A C o r24VDC , o rfro m a rechargeabl e Battery . Th e syste m include s a "Smar t Battery " charge rtha t recharge s th e Batter ywheneve rth e SARO S i s connecte d t o externa l power . Th e syste m monitor s an d control s bot h th e powe rsourc e an d th e Batter yCharger . 

# BASI C THEOR YO F OPERATIO N SARO S Oxyge n Syste m use s a variabl e spee d compresso rt o provid e bot h positiv e an d negativ e ai r pressur e an d i s drive n b ya Brushles s D C Moto r(BLDC ) an d driv e system . Th e ATF ®

Concentrato rModul e accept s positivel yan d negativel ypressurize d ai ran d extract s oxyge n fro m thi s ai rusin g th e Pressur e Swin g Adsorptio n (PSA ) process . Th e AT F modul e sub-component s consis t o f patente d rotar yvalves , manifold , housing , siev e beds , an d a steppe rmoto r/ gea rdriv e system . Th e rotar yvalv e syste m channel s th e ga s i n a sequentia l manne rt o eac h o f th e siev e beds . Eac h be d i s pressurize d t o forc e th e oxyge n throug h th e siev e an d int o th e produc t tan k whil e mos t o f th e nitroge n i s separate d an d remain s i n th e sieve . Onc e th e proces s i s maximize d the n th e siev e bed s ar e purge d o f th e nitrogen . Th e purge d nitroge n i s the n vente d t o atmospher e throug h th e exhaus t vent . Th e proces s i s continuousl yrepeate d i n eac h siev e bed . Th e flo wo f produce d oxyge n passe s fro m th e produc t tan k t o a flo wan d concentratio n monitorin g an d contro l syste m whic h utilize s a proprietar yultrasoni cflo wan d concentratio n sensor . I t the n continue s throug h a flo wcontro l valv e t o accuratel ycontro l th e flo wo f oxyge n i n continuou s an d puls e flo wmodes . Th e oxyge n the n passe s throug h a HEP Afilte ran d i s delivere d t o th e oxyge n outle t port . Th e oxyge n flo wrat e an d mod e ar e selecte d b yth e user . I n continuou s flo wmode , oxyge n i s delivere d continuousl ya t rate s o f 1 , 2 , an d 3 LP M and , i n puls e flo wmode ; a bolu s i s delivere d a t th e beginnin g o f eac h inspiratio n wit h selectabl e volum e deliver yapproximatel yequivalen t t o rate s betwee n 1 6 an d 9 6 mL . Th e SARO S electroni csystem , togethe rwit h embedde d operationa l firmware , provid e th e mean s t o manag e power , contro l oxyge n production , monito rsafet yfunction s an d interfac e wit h th e user . Powe r managemen t function s includ e switchin g betwee n variou s powe rinputs , drivin g th e compressor , AT F steppe rmotor , an d proportiona l valve , monitorin g batter ystatu s an d chargin g whe n powe ri s availabl e fro m a n externa l source . Syste m managemen t function s includ e monitorin g ai l flow , pressures , concentration s an d safet yfunctions . Use rInterfac e component s suc h a s buttons , illuminate d indicators , LC D displa yan d audi o transduce rar e als o monitore d o rcontrolled . Th e Use rInterfac e inform s th e use r o f th e syste m status , allow s th e use rt o selec t a continuou s flo wo rpuls e mod e flo wsettin g an d th e abilit y t o se t th e desire d flo wrate . Th e Utilit yButto n th e Use rInterfac e als o allow s th e Use rt o obtai n informatio n abou t th e syste m - hour s o f operation , softwar e versio n an d 9 V batter ystatu s - o rmak e selection s o n variou s feature s suc h a s Tactica l o rNorma l Mode , Trigge rSensitivit yAdjustments , Buzze r loudnes s an d LC D Brightnes s an d Contrast . 9 o f 8 9

# ATF®

CONCENTRATO R MODUL E Th e SARO S Oxyge n System , Mode l 300 0 wit h autoSA TTechnolog yuse s a passiv e syste m t o separat e oxyge n fro m air . Ai rflow s int o th e SARO S wher e i t i s filtere d an d the n enter s th e compressor . Pressurize d ai rflow s fro m th e compresso rint o th e AT F Concentrato rModul e wher e i t i s separate d int o oxyge n an d nitroge n components . Th e ai rseparatio n proces s use s a rotar yvalv e syste m t o forc e ai r throug h a serie s o f pressurize d siev e beds . Throug h a proces s know n a s "pressur e swin g adsorption, " nitroge n molecule s ar e collecte d o n a n adsorben t materia l o rzeolit e allowin g th e concentrate d oxyge n t o b e force d throug h a siev e be d int o th e produc t tank . Th e nitroge n molecule s ar e the n purge d fro m th e adsorben t materia l usin g a vacuu m pressur e cycle . Oxyge n flow s fro m th e produc t tan k throug h a senso rtha t measure s flo wan d concentratio n an d the n throug h a HEP Afilter . Aflo wcontro l valv e regulate s th e flo wo f concentrate d oxygen . Th e proces s i s continuousl yrepeate d durin g operation . 

# COMPRESSO R Th e SARO S compresso ri s a two-hea d variabl e spee d scrol l compresso rdrive n b ya highl yefficien t Brushles s D C (BLDC ) motor . Whe n ai rflow s int o th e compressor , i t passe s throug h a n ai rinle t mes h filte rtha t filter s ou t impurities . Usin g on e head , th e compresso rtake s i n filtere d air , compresse s i t an d channel s th e compresse d ga s t o th e AT F Module . Th e secon d hea d pull s a vacuu m o n th e AT F modul e an d exhaust s nitroge n ric h ga s throug h a n exhaus t outle t muffle rt o suppres s th e nois e an d the n t o th e exhaus t ven t a t th e botto m o f th e device . 

# BRUSHLES S COMPRESSO R MOTO R DRIVE R (BCMD ) Th e BCM D drive s th e compresso rmoto rbase d o n th e inpu t powe rfro m eithe rth e battery , th e A C Powe r Adapte ro rth e 2 4 VD C Cable . 

# COOLIN G FA N Acoolin g fa n i s installe d i n th e SARO S t o provid e force d ai rcoolin g t o th e variou s component s i n th e syste m tha t generat e heat . 

# POWE R BOAR D Th e Powe rBoar d take s externa l powe rtha t come s int o th e SARO S fro m th e A C Powe rAdapter , 2 4 VD C Cabl e o rBatter yan d monitor s an d control s powe rdistributio n t o th e res t o f th e OMN I system . Th e Powe r Boar d als o drive s th e coolin g fan . 

# SYSTE M BOAR D Th e Syste m Boar d i s th e cente ro f nearl yal l th e SARO S functions . Th e Syste m Boar d i s a microcontroller-base d syste m tha t monitor s syste m dynamic s suc h a s temperatures , pressures , AT F steppe rmoto ran d proportiona l valve , produc t flo wan d concentration , an d th e Users ' input , indicator s an d buzze roperatio n an d externa l communications . I t measure s temperatur e o f th e oxygen , compresso r motor , ambien t temperature , an d AT F temperature , BCMD , Powe rBoar d an d th e Battery . Th e Syste m Boar d utilize s a proprietar yultrasoni cflo wan d concentratio n senso ran d a flo wcontro l valv e t o accuratel ycontro l th e flo woxyge n i n th e variou s flo wdeliver ymodes .

1 0 o f 8 9

### Fro m Product Tan k Ullrasoni cFlo w Concentratio n Measuremen t miaMmmmi i 

### T o Outpu t Por

t

Produc t Pressur e Contro l Syste m 

# CONTRO L PANE L Th e Contro l Pane l provide s a use rinterfac e consistin g of a membran e pane l keyboards , Liqui d Crysta l Displa y(LCD) , externa l powe rpresen t indicator , Batter ycapacityindicator , alar m statu s indicators , an d a buzzer . Th e use rinterfac e inform s th e use rof th e syste m statu s an d allow s th e use rt o se t th e desire d flo wmode s an d flo wrat e - continuou s o rpulse , displa ymod e - tactica l o rnormal , se t u p syste m parameters an d acquir e syste m information .



# CONTINUOU S FLO W MOD E Th e use rmayse t th e SARO S oxyge n flo wrat e an d mode . Continuou s Flo wMod e deliver s a constan t flo wo f oxyge n t o th e Oxyge n Outle t Por t at setting s of 1 , 2 , an d 3 LPM . Withi n th e SAROS , concentrate d oxyge n i s store d i n a product tan k at pressure s i n th e rang e of 5 - 9 ps i an d i s back-pressur e compensated . Thi s pressur e give s Continuou s Flo wMod e th e capabilityt o delive rth e indicate d flo wrat e t o th e patien t eve n i f extensio n tubin g i s used , u p t o 5 0 fee t long . I n addition , th e SARO S Continuou s Flo wMod e i s full ycompatibl e wit h humidifie ruse .

1 1 o f 8 9

## PULS E FLO W MOD E WIT H autoSAT TM TECHNOLOG Y

Th e SARO S Puls e Flo wMod e wit h autoSAT TM Technolog ydeliver s a hig h flo wo f oxyge n a t th e ver y beginnin g o f eac h inspirator yeffort . Th e approac h i s base d o n th e manne ri n whic h ga s i s delivere d int o a patient' s airway . SARO S use rma yselec t puls e volum e deliver yrate s betwee n 1 6 an d 9 6 ml . Puls e duration s var ybetwee n 10 0 millisecond s an d 50 0 millisecond s du e t o dea d spac e considerations . Th e fundamenta l approac h t o triggerin g an d controllin g th e oxyge n bolu s i n Puls e Flo wMod e is : Th e use rma yselec t puls e trigge rsensitivit yi n setting s 1 (mos t sensitive) , 2 , o r3 (leas t sensitive) . Th e puls e wil l b e triggere d whe n th e syste m meet s al l th e followin g criteria : Th e cannul a pressur e ha s droppe d belo wth e trigge rpoin t (typicall ybetwee n 0.1 5 an d 0.4 5 cmHzO) . A t les t 1.2 5 second s ha s passe d sinc e th e las t puls e began . Th e SARO S autoSAT TM Technolog yconsistentl ymaintain s th e Fi0 2 b yadjustin g t o th e patient' s respirator yrate . A s thei rrat e increases , th e autoSAT TM featur e serv o control s th e devic e t o automaticall y increas e oxyge n outpu t t o ensur e uninterrupte d deliver yo f th e se t bolu s volume . autoSAT TM provide s th e patien t wit h unparallele d performanc e withou t limitin g availabl e oxygen , enablin g th e syste m t o automaticall yadjus t t o increase d oxyge n demand s tha t ofte n occur . 

## UTILIT YMOD E AUse ro rServic e Technicia n ca n acces s th e Utilit yMod e functio n b ypressin g usin g th e Utilit yButto n o n th e contro l panel . Al l informatio n i s displaye d o n th e LCD . Advanc e t o th e nex t featur e i n th e Utilit yMod e b ydepressin g th e Utilit yButton . Th e "+ " or"- " butto n i s use d t o toggl e whe n a featur e i s selected . Pressin g th e Flo wMod e butto n take s yo u bac k on e step . 

## SERVIC E MOD E FUNCTION S Factor ymaintenanc e o rservic e update s ma ysometime s b e require d o n th e SAROS . Factor yan d qualifie d factory-traine d technician s ca n acces s servic e mod e softwar e function s b yusin g th e Servic e Por t locate d o n th e to p o f th e unit . . 

## POWE R SUPPLIE S SARO S ma yoperat e fro m eithe ra n A C Powe rAdapter , 2 4 VD C Cabl e o rBattery . Whe n powe ri s availabl e fro m a n externa l supply , th e SARO S wil l dra wfro m th e externa l sourc e rathe rtha n depletin g th e Battery . Connectio n t o externa l powe ri s indicate d whe n th e Externa l Powe rPresen t Indicato rlocate d o n th e Contro l Pane l i s illuminated . 

## A C POWE R ADAPTE R Th e A C Powe rAdapte ri s a universa l inpu t type , capabl e o f acceptin g 10 0 - 24 0 VAC , 50/6 0 Hz . I t i s capabl e o f deliverin g u p t o 200 W a t 2 4 VD C output . Th e inpu t cor d require s a grounde d receptacle . Countr yspecifi ccord s ma yb e use d wit h th e A C Powe rAdapter , a s th e suppl yi s equippe d wit h a universa l inpu t receptacle . Whe n use d i n a medica l car e facility , internationa l safet ystandard s requir e th e us e o f hospita l grad e A C powe rcor d wit h th e SAROS .

1 2 o f 8 9Th e A C Powe rAdapte rcontain s protectio n circuit s fo routpu t over-current , inpu t over-voltage , an d

interna l over-temperatur e conditions , i f an yo f thes e condition s exist , outpu t powe rwil l b e a Los s of Powe rAlarm . Refe rt o Alert , Alarm s an d Troubleshootin g Table . Thes e thre e condition s ar e self resetting , suc h tha t outpu t powe rwil l resum e whe n protectio n circuit s fal l bac k int o acceptabl e operatin g ranges . 

# 2 4 VD C CABL E Th e 2 4 VD C Cabl e i s intende d fo rus e wit h 2 4 vol t powe rsources , suc h a s thos e foun d i n variou s vehicles .



# BATTER Y Th e Batter

yallow s operatin g th e SARO S awayfro m A C o rD C power . Th e Batter yuse d wit h th e SARO S contain s Lithiu m Io n batter ycells , simila rt o thos e use d i n lapto p computer s an d cel l phones . Th e SARO S Batter yi s approximatel y8 6 W-hour s i n capacit yan d provide s a n outpu t voltag e of 12V t o 16.8V . Th e Batter yconnect s t o th e botto m o f th e SARO S an d i s secure d b ya mechanica l latchin g mechanism . Th e Batter yca n b e recharge d whe n th e SARO S i s connecte d t o th e A C Powe rAdapte ro rth e 2 4 VD C Cable . Th e Batter

yGaug e indicato ro n th e SARO S LC D wil l hav e a "waterfall " effect whe n th e Batter yi s charging . Th e fastes t wa yt o recharg e th e Batter yi s usin g th e A C Powe rAdapter .

Th e Batter

yha s a n integra l safet ycircui t tha t prevent s ove rcharge , ove rdischarg e o rdamag e du e t o a n externa l shor

t circui t o f th e pack . A n Integra l fue l gaug e communicate s batter yvoltage , current , charg e state , an d temperature . Base d o n th e voltag e supplie d b yth e Battery , th e syste m i s configure d t o optimiz e batter

ychargin g byregulatin g th e chargin g voltag e an d curren t a s follows :

1 3 of 8 9Batter yPac k Outpu t Voltag e (VDC ) <10. 0 10.0-11. 9 >12. 0 Chargin g Voltag e (VDC ) FAUL T 16. 6 16. 6 Chargin g Curren t (A ) FAUL T 0.6 6 5.6 0 Whe n th e SARO S i s operatin g o n Batter ypower , th e LC D display s a n estimat e o f th e amoun t o f tim e th e uni t ca n operat e a t th e curren t settings , withi n +/ - 5 minutes . Whe n th e SARO S i s operatin g o n Batter y an d th e tim e o n batter yfall s belo w1 5 minutes , th e LC D tim e o n batter ycharacter s wil l flas h t o indicat e a lo wbatter ycondition . Th e capacit yo f th e SARO S Batter yi s determine d b yelectronic s an d software . Whil e th e SARO S Batter y allow s th e concentrato rt o operat e a t it s ful l rang e o f capabilities , th e primar ypurpos e o f th e Batter yi s t o allo wa n autonomou s syste m whil e movin g betwee n A C o rD C powe rsources . Th e SAROS' s Battery , lik e al l lithiu m io n batteries , i s susceptibl e t o permanen t damag e fro m excessiv e heat . Exposur e t o excessiv e hea t ma yshorte n th e Battery' s servic e life . Th e Batter ycontain s multipl e temperatur e sensor s t o monito rbatter ycel l temperature . Th e amoun t o f hea t th e Batter yca n safel yendur e varie s dependin g o n ho wth e Batter yi s bein g used . Durin g discharge , th e SARO S softwar e wil l alar m whe n interna l batter ycel l temperatur e exceed s 60°C , an d wil l shu t th e syste m dow n i f interna l batter ycel l temperatur e exceed s 59°C . Whil e th e Batter yi s charging , softwar e wil l interrup t charge roperatio n whe n th e interna l batter ytemperatur e exceed s 40° C o rtemperatur e i s les s tha n 5°C . I n bot h o f thes e cases , whe n interna l batter ycel l temperatur e return s withi n thes e limits , th e SARO S wil l resum e norma l operation . Operatio n nea rthes e temperatur e limit s wil l no t damag e th e Battery , bu t ar e i n plac e t o ensur e tha t th e servic e lif e o f th e Batter yi s preserved . Hea t i n th e Batter yi s generate d durin g discharge , an d ca n als o b e th e resul t o f operatin g th e SARO S i n hig h ambien t temperatures . Th e amoun t o f internall ygenerate d hea t varie s wit h th e flo wsettin g - highe r flow s induc e greate rBatter yheating . Whil e hig h ambien t temperature s ar e typicall yth e resul t o f operatio n o n a ho t day , runnin g th e SARO S wit h inadequat e ventilatio n ca n als o caus e additiona l heat . Alway s ensur e tha t th e SARO S i s operate d i n a well-ventilate d space , th e ai rintak e filte ri s clean , an d intak e an d exhaus t vent s ar e unobstructed . 

## CHARGIN G ALGORITH M Th e chargin g algorith m i s performe d b yth e Powe rBoar d softwar e an d involve s thre e basi cdecisions :

1 . Whe n t o star t chargin g 2 . Ho wfas t t o charg e 3 . Whe n t o sto p chargin g Chargin g begin s whe n Batter yvoltag e fall s belo w93 % relativ e capacity . Th e chargin g curren t i s limite d b yth e charge rcapabilit yan d th e rate d capacit yo f th e Battery . Unde rcertai n conditions , th e SARO S ma y no t hav e enoug h externa l powe ravailabl e t o charg e th e batterie s a t th e ful l rate . I n thi s case , th e chargin g rat e wil l b e limite d t o th e availabl e power . A s th e Batter yaccumulate s charge , th e chargin g curren t require d wil l eventuall yfall . Batter ychargin g wil l ceas e whe n th e Batter yvoltag e i s greate rtha n 16V , charg e curren t i s les s tha n 0.66A , an d relativ e charg e i s greate rtha n 93% . Th e softwar e wil l onl ycharg e whe n th e Batter ytemperatur e i s a t o rbelo w40°C . Th e softwar e wil l alway s ru n th e coolin g fa n wheneve rth e charge ri s enabled . Th e Batter yCharge ri s disable d an d th e coolin g fa n i s se t t o maximu m wheneve rth e Batter ytemperatur e exceed s 40°C . Th e Batter ycharge ri s disable d whe n temperatur e i s les s tha n 5°C . 1 4 o f 8 9Al l lithiu m io n batterie s self-discharg e a t ver ylo wrate s whe n not i n use . SARO S Batterie s ar e shippe d fro m SeQua l i n a partiall ycharge d stat e (nominall y40%) . Whe n th e Batter yi s store d i n a cool , dr

y location , i t i s recommende d t o recharg e th e Batter yever y3 months . SeQua l recommend s a firs t in , firs t ou t rotatio n o f Batter

yinventor

yfo rmaximu m servic e life .

1 5 o f 8 9Th e followin g sectio n i s intende d t o assis t th e Traine rt o provid e a basi covervie wo f th e SARO S Oxyge n

Syste m fo rSe t up , use , routin e maintenance , troubl e shootin g an d repair . Settin g u p an d trainin g t o use , maintai n an d servic e th e AChec k Lis t i s provide d t o assis t yo u i n coverin g variou s aspect s o f th e system . Prope rtrainin g o f th e user s wil l resul t i n fewe rservic e calls , improve d complianc e an d utilizatio n o f th e SARO S t o it s fulles t capability . Befor e deliverin g th e device , chec k an d lo g th e statu s o f th e following : Part s Inventor y- Verif ytha t eac h SARO S i s provide d wit h th e followin g items :

• Technica l Manua l • SARO S Concentrato r • Cannul a • A C Powe rCor d • A C Powe rAdapte r • 2 4 Vol t D C Cabl e • Batter y • Spar e Filte rSe t Powe rSource s - Inser t an d chec k th e followin g fo rprope roperation :

• A C Powe rAdapte rwit h Powe rCor d • 2 4 VD C Cabl e • Batter y Electrica l Syste m - Us e th e Contro l Pane l t o chec k and/o radjus t th e following : Featur e Tactica l o rNorma l Mod e Alar m Code s Puls e Sensitivit ySettin g LC D Contras t Tactica l Buzze rVolum e Tactica l Mod e Brightnes s Norma l Mod e Brightnes s 9 V Batter yStatu s Hour s o f Operatio n Syste m Softwar e Par t Numbe ran d Revisio n Moto rSoftwar e Par t Numbe ran d Revisio n Factor yDefaul t TAC TO N AC=NON E 2 3 3 3 2 GOO D Actua l Hour s Lates t Revisio n Lates t Revisio n

1 6 o f 8 9TRAININ G TOPI C

Pre-Deliver ychec k

Lis t Indication s fo rUs e Contraindication s BASI C CONCEP TTRAININ G Rea d th e Technica l Manua l Devic e Specification s Safel yGuidelines , Warnings/Caution s Locatin g Devic e Use rPane l Button s an d Indicator s Alert s an d Alarm s Attachin g th e A C Powe rAdapte r Attachin g th e 2 4 VD C Cabl e Attachin g an d removin g th e Batter y Turnin g th e devic e O N an d OF F Selectin g Flo wMod e an d Setting s

- Selectin g Continuou s Flo wMod e

- Selectin g Puls e Flo wMod e wit h autoSA T Readin g th e Displa y Accessin g th e Utilit yMen u

- Tur n of f Tactica l Mod e

- Alar m code s

- Puls e Sensitivit ySettin g

- LC D Contras t

- Tactica l Buzze rVolum e

- Tactica l Mod e Brightnes s

- Norma l Mod e Brightnes s

- 9 V Batter yStatu s

- Hour s o f Operatio n

- Syste m Softwar e Par t Numbe ran d Revisio n

- Moto rSoftwar e Par t Numbe ran d Revisio n CLEANING , CAR E AN D MAINTENANC E

- Devic e an d accessor ycleanin g

- Replacin g th e filter s an d 9 V batter y TROUBLESHOOTIN G AN D REPAI R TRAINE D BY : INITIALS/DAT E

1 7 o f 8 9

# SARO S Oxyge n Syste m Technica l Manua l - Ho wt o us e i t

1 8 o f 8 9

# Importan t SafetyInstruction s

SeQual ® Technologie s Inc . (SeQual ) recommend s tha t thi s Technica l Manua l b e give n t o eac h use r receivin g a n SARO S Oxyge n System . Thi s manua l provide s al l o f th e necessar yinformatio n neede d fo ra user , o rclinician , t o successfull yoperat e th e SAROS . 

## SYMBOL S USE D I N TH E TECHNICA L MANUA L AN D O N SARO S Refe rt o thi s sectio n fo ra n explanatio n o f th e symbol s an d th e Warning s tha t accompan ythem . [_Jl J "Rea d Instructions" : Pleas e consul t th e Technica l Manua l instruction s provide d wit h th e product . / [ \ "Attentio n o rCaution" : Indicate s importan t informatio n tha t require s th e use rt o tak e specia l precaution s whe n certai n condition s ar e present . "N o Smokin g o rOpe n Flames" : Th e us e o f oxyge n require s tha t specia l car e b e take n t o reduc e th e risk

o f fire . Material s tha t bur n i n air , an d eve n som e material s tha t wil l no t bur n i n air , ar e easil yignite d an d bur n mor e rapidl yi n hig h concentration s o f oxygen . Fo rsafet yconcerns , al l possibl e source s o f ignitio n mus t b e kep t awa yfro m th e SARO S an d preferabl you t o f th e roo m i n whic h i t i s bein g used . Smokin g i n th e proximit yo f a n operatin g SARO S i s dangerous , an d ca n permanentl ydamag e th e devic e an d voi d th e warranty . rsc ) "Us e N o Oil s o rGrease" : Indicate s importan t informatio n abou t th e possibilit yo f spontaneou s an d violen t ignitio n tha t ma yoccu ri f oils , greas e o rothe rpetroleu m base d substance s com e int o contac t wit h oxyge n unde rpressure . IPX 2 Drippin g Rain : Th e SARO S Batter ywil l provid e protectio n agains t wate ringres s accordin g t o th e specification s indicated . Wate rspraye d a t a n angl e u p t o 15 ° o n th e outsid e shal l hav e n o harmfu l effect s (IPX2 . pe rlE C 60529) . IPX 1 Dri p Proo f Equipmenl-IPXI : Th e SAROS , th e A C Powe rAdapte ran d 2 4 VD C Cabl e provid e protectio n agains t th e harmfu l effect s o f th e ingres s o f liquids . (IPX , pe rlE C 60529) .

lE C Ico n fo rD C Powe r(Input )

n ^ "Typ e B Equipment" : Indicate s equipmen t providin g a particula rdegre e o f protectio n agains t electri cshock , particulari yregarding :

• Allowabl e leakag e current ; • Reliabilit yo f th e protectiv e eart h connectio n (grounding) . A"Amperes "

1 9 o f 8 9-'"Nw ^ "Alternatin g Current " / V ) "Audibl e Alarm" : A n audibl e indicato ri s provide d t o announc e a reductio n i n oxyge n concentratio n o rwhe n th e powe rha s bee n interrupte d o rlost . "ON/OFF " (Standby) : Power s th e devic e O N o rOFF , bu t doe s no t directl ydisconnec t th e main s power . m m "Increas e Flo wSetting" : Increase s th e flo wsettin g b y1 LP M an d puls e volum e b y1 6 m L increment s eac h tim e th e butto n i s pressed . "Decreas e Flo wSetting" : Decrease s th e flo wsettin g b y1 LP M an d puls e volum e b y1 6 m L increment s eac h tim e th e butto n i s pressed . "Flo wMode" ; Activate s eithe rContinuou s Flo wMod e o rPuls e Flo wMod e Operation .

^^^ H "Externa l Powe ri s Presen t Indicator" : Indicate s th e presenc e o f externa l power . "Batter yStatu s Gauge" : Show s th e amoun t o f charg e remainin g i n th e Battery . O 2 "Oxyge n Output" : Th e por t fro m whic h th e oxyge n flow s an d wher e th e tubin g o rinterfac e (standar d nasa l cannula ) i s attached . r^j— " • Utility : Th e Butto n tha t activate s a Utilit yMen u t o acces s informatio n o rt o chang e settings .

' > .Recycl e Symbo l

^ WEE E Symbol : D o No t Discard , Recycle . Contac t th e loca l cit yo rtow n office s fo rinstruction s o n prope rdisposa l o f th e Batter , electrica l o relectroni cequipment . E C RE P I Authorize d Europea n Representativ e

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# Indication s fo rUs e

SARO S OXYGE N SYSTE M I S INDICATE D FO R TH E ADMINISTRATIO N O F SUPPLEMENTA L OXYGEN . TH E DEVIC E I S NOTINTENDE D FO R LIF E SUPPOR TNO R DOE S I TPROVID E AN Y PATIEN TMONITORIN G CAPABILITIES . APHYSICIA N HA S PRESCRIBE D ASPECIFI C OXYGE N FLOW SETTIN G T O MEE TA N INDIVIDUAL' S NEEDS . OXYGE N FLO W SETTING S SHOUL D B E ADJUSTE D ON L YUNDE R TH E DIRECTIO N O F A PHYSICIA N 

### WARNIN G FEDERA L U.S . LA W RESTRICT S THI S DEVIC E T O SAL E BYO R O N TH E ORDE R O F APHYSICIAN . 

# Contraindication s WARNIN G I N CERTAI N CIRCUMSTANCES , TH E US E O F NON-PRESCRIBE D OXYGE N CA N B E HAZARDOUS . THI S DEVIC E SHOUL D ONL YB E USE D UNDE R TH E DIRECTIO N O F APHYSICIA N O R QUALIFIE D CLINICIAN . NO TFO R US E I N TH E PRESENC E O F FLAMMABL E ANESTHETICS . A S WIT H AN YELECTRICALL YPOWERE D DEVICE.JH E USE R MA YEXPERIENC E PERIOD S O F NON-OPERATIO N A S ARESUL TO F ELECTRICA L POWE R INTERRUPUTION , O R TH E NEE D T O HAV E TH E SARO S SERVICE D B YAQUALIFIE D TECHNICIAN . SARO S I S NO TAPPROPRIAT E FO R AN YPATIEN TWH O WOUL D EXPERIENC E ADVERS E HEALT H CONSEQUENCE S A S TH E RESUL TO F SUC H TEMPORAR YINTERRUPTION . US E O F A N OXYGE N MAS KI S CONTRAINDICATE D DU E T O TH E POSSIBILIT YO F REBREATHIN G EXHALE D CARBO N DIOXIDE . 

# SafetyGuideline s Thes e are Warning s an d Caution s tha t appl yt o hazard s o runsaf e practice s tha t coul d resul t i n seriou s injur yo rpropert ydamage . Kee p SARO S an d th e powe rcor d awa yfro m ho t surface s o rope n flames . SARO S shoul d b e locate d i n a well-ventilate d are a t o allo wfo radequat e ai rintake . Avoi d th e intak e o f airborn e pollutants , smok e an d fumes . ONL Yus e thi s devic e wit h accessorie s specifie d by , o rrecommende d by , SeQual . I f SARO S ha s bee n dropped , damage d o rexpose d t o wate rpleas e contac t a qualifie d technicia n fo rinspectio n o rpossibl e repai ro f th e device . Whe n usin g SARO S i n an yvehicle , b e sur e i t i s properl ysecured , belte d o rrestrained . D O NOTus e SARO S i f i t ha s a damage d powe rcor d o rplug . 2 1 o f 8 9• D O NOTdro p o rinser t an yobject s int o an yopenin g o n th e device . • D O NO Tbloc k

th e ai rinle t o rth e exhaus t ven t o f th e SARO S whe n i t i s o n a sof t surface , suc h a s a litter , bed , chair , carpet , couc h o rvehicl e seat . • D O NOTcove rth e devic e wit h a blanket , towe l o rsheet , etc . • D O NOToverfil l th e optiona l humidifier . Fil l th e optiona l humidifie rwit h wate rt o th e leve l show n b yth e manufacture ro f th e humidifier . 

### WARNIN G D O NO TREMOV E TH E COVER . THER E AR E N O USER-SERVICEABL E PART S INSID E TH E DEVICE . ONL YQUALIFIE D SERVIC E PERSONNE L SHOUL D REMOV E TH E COVE R O F TH E DEVICE . D O NOTOPERAT E TH E DEVICE , COMPONENT S O R ACCESSORIE S O N WE TSURFACE S O R I N STANDIN G WATE R AN D D O NO TSUBMERS E I N WATER . PROTEC TELECTRICA L POWE R CORD S FRO M SHAR P EDGES . ELECTRICA L SHOC KAN D SERIOU S PHYSICA L INJUR YMA YOCCUR . ONLYUS E TH E SEQUA L SUPPLIE D A C POWE R ADAPTE R AN D 2 4 VD C CABL E WIT H YOU R SAROS . US E O F AN YOTHE R A C POWE R ADAPTE R O R D C CABL E MAYB E HAZARDOUS , CAUS E SERIOU S DAMAG E T O YOU R SARO S AN D WIL L VOI D TH E WARRANTY . AVAILABILIT YO F A N ALTERNATE , O R BACK-UP , SOURC E O F SUPPLEMENTA L OXYGE N I S RECOMMENDE D I N CAS E O F APOWE R OUTAG E O R AMECHANICA L FAILUR E O F TH E DEVICE . 

### CAUTIO N LOCAT E OXYGE NSUPPL Y TUBIN G AN D AL L POWE R CORD S I NAMANNE R T O PREVEN T TRIPPIN G HAZARDS . D O NO T PLAC E TH E SARO S I NASMALL , ENCLOSE D SPACE , SUC H A S ABATHROOM , CLOSET , O R BO X WIT H TH E OXYGE NCANNUL AO R TUBIN G LEADIN G OU T O F TH E ENCLOSE D SPACE . D O NO T EXPOS E TH E DEVIC E T O TEMPERATURE S OUTSID E O F TH E SPECIFIE D RANG E O F OPERATIN G O R STORAG E TEMPERATURE S A S THI S MA Y DAMAG E TH E DEVICE .

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# Batter ySafet y

WARNIN G D O NO TDISASSEMBLE , PUNCTURE , O R CRUS H TH E BATTERY . BATTER YELECTROLYTE S MA Y B E TOXI C I F SWALLOWE D AN D CA N B E HARMFU L T O SKI N AN D EYES . KEE P TH E BATTER Y AWA YFRO M CHILDREN . D O NO TSHORT-CIRCUI TTH E BATTERY' S META L CONTACT S WIT H METALLI C OBJECTS , SUC H A S KEY S O R COINS . THI S MAYCAUS E SPARK S O R EXCESSIV E HEATT O B E GENERATED . US E O F ADAMAGE D BATTER YMAYCAUS E PERSONA L INJUR Y TH E BATTER YMAYEXPLOD E AN D CAUS E POTENTIA L INJUR YI F EXPOSE D T O AFIRE , O R DISPOSE D O F I N AFIRE . EXPOSIN G TH E BATTER YT O WATE R O R OTHE R LIQUID S MA YCAUS E PERSONA L INJURY . 

### CAUTIO N D O NOTEXPOS E TH E BATTER YT O TEMPERATURE S ABOV E 140 ° F (60°C) , SUC H A S I N A VEHICL E PARKE D I N TH E SU N O N AHOTDAY . I TI S NO TRECOMMENDE D THA TTH E BATTER YI S CHARGE D BELO W 4 1 F ° (5 ° C ) O R ABOV E 104 ° F (40 ° C) . ONLYUS E TH E BATTER YFO R IT S INTENDE D PURPOSE .

2 3 o f 8 9

# INTRODUCTIO N T O YOU R SARO S OXYGE N SYSTE M

Thi s Technica l Manua l wil l infor m yo u abou t th e us e an d car e of th e SAROS , it s standard component s an d th e optiona l accessories . Pleas e rea d thoroughl yal l of th e informatio n i n thi s manua l befor e operatin g th e SARO S an d receiv e prope rtrainin g o n th e us e an d car e of thi s device . 

### APHYSICIA N HA S PRESCRIBE D SUPPLEMENTA L OXYGE N A S PAR TO F A TREATMEN TPLA N T O MEE TA N INDIVIDUAL' S CLINCIA L NEEDS . OXYGE N FLOW MODE S AN D SETTING S SHOUL D B E ADJUSTE D ONL YUNDE R TH E ADVIC E O F A PHYSICIA N O R CLINICIAN . Arepresentatio n o f th e majo rfeature s o f th e SARO S hardwar e interfac e are show n belo w

• Membran e Pane l containing : • Fiv e tactil e button s allo wcontro l of al l use rcontrollabl e setting s " Five variabl e intensit yLE D indicators provid e overal l statu s • A n 8 characte rLC D displa yshow s setting s 9V Batter y Oxyge n Outle t Por

t Externa l Powe rConnecto r Dat a Communication s Connecto r Batter y Simplifie d Use rinstruction s Labe l Mai n / Ratin g Labe l Particulat e Mesh/Inle t Filte r

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# Understandin g th e Control s o n th e Fron t Pane l

DESCRIPTIO N O F TH E SARO S Becom e familia rwit h th e ke yfeature s of th e SARO S an d th e use rcontro l panel . Particulate Mesh/Inle t Filter Cover

Oxygen Outlet Por t HEP A Filter

Main/Ratin g Label (Underneath ) Batter y Simplifie d User Instruction s Label (Behind )



### FRON T- CONTRO L PANE L BAC K- SIMPLIFIE D INSTRUCTION S

2 5 o f 8 9

### TO P

External Power Connecto r Oxygen Outlet Por t BOTTO M -WITHOU TBATTER Y

Main/Ratin g Label

SERVIC E POR T(USB ) BOTTOM-WIT H BATTER Y 

# N Exhaus t

Ven t

Pus hButto n t o releas e Batter y

2 6 o

f 8 9

### Input/Outpu t Connection s

Oxyge n Outle t Por t Oxyge n suppl ytubin g o ra cannul a i s attache d t o thi s port . Particulat e Mesh /

Inle t Filte rAmbien t ai ri s draw n int o th e devic e throug h th e ai rinle t locate d a t th e

to p o f th e device . Thi s ai rinle t filte rprevent s dus t /debri s fro m enterin g th e SARO S an d shoul d b e cleane d regulariy . Servic e Por t Thi s connectio n allow s qualifie d servic e personne l t o diagnos e an d monito rth e SARO S performance . I t i s no t intende d fo rth e user . Externa l Powe rReceptacl e Th e SARO S A C Powe rAdapte ro r2 4 VD C Cabl e connect s t o thi s receptacle . Exhaus t Ven t Exhaus t ai rfro m th e SARO S leave s th e devic e fro m thi s vent .

2 7 o f 8 9

## USE R CONTROL S AN D SYSTE M STATU S INDICATOR S

Th e SARO S Use rContro l Pane l display s importan t operatin g information . Thi s sectio n wil l hel p yo u understan d thi s operatin g information . Tactica l Mod e i s provide d fo roperatio n wher e nois e an d ligh t ma ycompromis e a situation , I n thes e situations , th e LE D indicator s wil l b e of f an d th e audi o indicato rsoun d i s reduced . Th e syste m alway s start s u p i n Tactica l Mod e an d ca n b e change d t o Norma l Mod e b ydepressin g th e Utilit yButto n an d the n th e Decreas e butto n t o chang e fro m TACT=O N t o TACT=OFF . Tactica l Mod e i s indicate d b ya "T " o n th e LCD . Norma l Mod e provide s al l LE D indication s wit h ful l brightness , ful l audi o indicato rsoun d an d LC D backligh t Norma l Mod e i s indicate d b ya n "N " o n th e LCD . Green , Yellow , an d Re d Indicator s o n th e fron t pane l indicat e th e operatin g conditio n o f th e device . Fo r additiona l informatio n o n thes e indicator s se e th e Alerts , Alarm s an d Troubleshootin g Tabl e i n thi s manual . ON/OF F (Standby ) Butto n -Gree n Indicator : Thi s butto n power s th e devic e O N o rpower s i t OFF . Th e Gree n indicato ri s illuminate d whe n th e devic e i s powere d O N an d operatin g i n th e Norma l Mod e an d of f whe n operatin g i n Tactica l Mode . ^jf-U H Increas e o rDecreas e Flo wSettin g Button : Us e thes e button s t o se t th e flo wo rt o mak e selection s i n th e Utilit yMenu . Deliver yMod e Butto n an d Indicato r(Blue) : Th e SARO S contain s a butto n t o toggl e betwee n Continuou s Flo wan d Puls e Flo wmode . Th e Puls e Flo wmod e activate s autoSAT TM Technolog y- a s breat h rat e changes , th e syste m adjust s t o provid e a consisten t bolu s size . Th e Puls e Flo wMod e allow s a significan t increas e i n operatin g tim e whe n powere d b ya Battery . Whe n th e Puls e Flo wMod e i s activated , th e blu e Flo wMod e Indicato rilluminate s an d a puls e o f oxyge n i s delivere d wit h eac h inspirator yeffort . Whe n th e puls e o f oxyge n i s delivered , th e flo wmod e indicato rturn s off . Change s i n flo wmod e shoul d onl yb e mad e b ya clinician . 

# o / \ ALER T(Yellow ) Indicato r- Lo wan d Mediu m Priorit yAlerts : I n Norma l Mode , whe n illuminated , thi s indicate s a lo wpriorit yawarenes s conditio n o rCaution . Continu e t o us e you rsyste m an d refe rt o th e Alerts , Alarms , an d Troubleshootin g Tabl e fo rth e prope rresponse . A flashin g yello windicate s a mediu m priorit yalert . Apromp t respons e i s necessary . I n Tactica l Mode , a blinkin g sta r"* " indicate s a n alert . 

# A ^ ALAR M (Red ) Indicator - Hig h Priorit yAlarms : I n Norma l Mode , whe n illuminated , thi s indicate s a hig h priorit yalar m condition . A n immediat e respons e i s necessary . Refe rt o th e Alerts , Alarms , an d Troubleshootin g Tabl e an d contac t a qualifie d servic e technician . I n Tactica l Mode , a blinkin g sta r"* " indicate s a n alert . Buzzer : A n audibl e alar m (o rbuzzer ) i s use d t o aler t yo u t o th e operatin g conditio n o f th e device , eithe ra warnin g o rfailure , an d t o confir m a vali d ke ypres s b yth e user . 2 8 o f 8 9Flo wSettin g Indicator : Thi s i s th e mai n focu s o n you rcontro l panel . Aclinicia n wil l correctl yse t

th e prescribe d flo wfo reithe rth e CX - Continuou s Flo wMod e a t X LP M (1 , 2 o r3 ) and/o rth e PXX X - Puls e Flo wMod e XXX m l (16 , 32 , 48 , 64 , 80 , 96 ) settings . Eac h tim e th e devic e i s turne d ON , i t wil l operat e at C 3 ( 3 LPM ) continuou s flo wi n th e Tactica l DisplayMode . I Batter yStatu s Gauge :

• ••I I Thi s indicato rdisplay s th e charg e remainin g i n th e Battery . Whe n th e Batter yi s full ycharge d al l 5 gray bars ar e illuminated . Eac h gra yba rrepresent s approximatel y20 % o f th e tota l Batter ycharge . Whe n th e Batter yi s bein g charged , th e charg e indicato rbars wil l waterfall . I f th e Batter yi s not installed , o ri f i t i s improperi yinstalled , th e Batter yStatu s Gaug e wil l no t b e illuminate d an d Tim e o n Batter yi s not displayed . Externa l Powe ri s Presen t Indicator : Whe n th e SARO S i s properl yplugge d i n an d i s usin g th e A C o r2 4 VD C Cable , thi s indicato rwil l illuminat e o n th e Use rContro l Pane l i n Norma l Mode . 

### Example s o f LC D displa ya t Powe rU p

Exampl e of LC D Displa yindicate s th e followin g information : Continuou s Flo wat 3 LPM , Tactica l Mode , Batter ybetwee n 81 % an d 100 % of capacity , 2 9 minute s of batter yoperatin g tim e remains . Batter ysymbo l i s animate d wit h a waterfal l effect whe n charging .

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### Exampl e o f LC D displa ydurin g Continuou s Mod e

Exampl e o f LC D Displa yindicate s th e followin g information : Continuou s Flo wa

t 2 LPM , Norma l Mode , Batter ybetwee n 61 % an d 80 % o f capacity , 2 4 minute s o f batter yoperatin g tim e remains . Batter ysymbo l i s animate d wit h a waterfal l effect whe n charging . 

### Exampl e o f LC D displa ydurin g Puls e Mod e

Exampl e of LC D Displayindicate s th e followin g information : Puls e mod e a

t bolu s siz e of 4 8 mL , Tactica l Mode , Batter ybetwee n 61 % an d 80 % of capacity , 1. 1 hours of batter yoperatin g tim e remains . Batter

ysymbo l i s animate d wit h a waterfal l effect whe n charging .

3 0 o f 8 9

# Recommende d Operatin g Environment s

Th e followin g char t provide s importan t informatio n concernin g th e recommende d operatin g environments , o roperatin g conditions , fo rprope rus e o f th e device . Operatin g Temperatur e Operatin g Humidit y Transport/Storag e Temperatur e Electrica l Altitud e Placemen t Environmen t Operatin g Tim e 0 ° C t o 43 ° C 10 % - 95 % a t a n 82.4 ° F (28 ° C ) de wpoin t -4 ° F t o 140 ° F (-20 ° C t o 60 ° C ) Humidity ; U p t o 95 % Non-Condensin g Us e n o extensio n cord s o relectrica l outlet s controlle d b ya switch . 0 - 18,00 0 fee t ( 0 - 5,48 6 meters ) D O NO Tbloc k

th e ai rinle t o rth e exhaus t vent . Plac e devic e a minimu m o f 3 inche s (7. 5 cm ) awa yfro m walls , draperies , furniture , etc. ) Mus t b e smoke , pollutant , an d fum e free . 24-hour s pe rda ywhe n connecte d t o a n externa l A C Powe r Adapte ro r2 4 VD C Cable . NOTE : Whe n movin g th e SARO S fro m a n extrem e temperatur e environment , pleas e allo wtim e fo ryou r devic e t o acclimat e t o th e recommende d operatin g temperatur e environment . 

### WARNIN G OPERATIN G TH E SARO S OUTSID E O F TH E RECOMMENDE D OPERATIN G TEMPERATUR E ENVIRONMEN TMA YNEGATIVEL YIMPAC TDEVIC E PERFORMANCE , MA YCAUS E DAMAG E T O TH E DEVIC E AN D WIL L VOI D TH E WARRANT YI F THI S OCCURS . OPERATIN G TH E SARO S UNDE R HIG H AMBIEN TTEMPERATUR E CONDITION S MA YRESUL TI N HIG H PRODUC TGA S TEMPERATURE .

3 1 o f 8 9

## TH E PROPE R LOCATIO N

Select a locatio n fo rth e devic e tha t avoid s th e intak e o f smoke , fume s an d pollutants . Correct placemen t o f th e devic e shoul d allo wintak e o f ai rthroug h th e ai rinle t filte ra t th e to p an d allo wexhaus t ai rt o freel y leav e th e exhaus t ven t a t th e botto m o f th e device . Locat e th e devic e suc h tha t th e alarm s ca n b e heard an d Positio n th e oxyge n suppl ytubin g i n suc h a way tha t i t doe s no t kin k

o rocclude . Kee p th e SARO S at leas t fiv e (5 ) fee t (1. 5 m ) awa yfro m hot , sparkin g object s o rope n flames . D O NO Tlocat e th e devic e nea rflammabl e material s o rcleanin g agent s o ri n th e direct pat h o f an yheat source , suc h a s a stove , range , heat registe ro rca rheater . 

# Operatin g Instruction s BEFOR E OPERATIN G Thi s Technica l Manua l serve s a s you rreferenc e t o hel p yo u operat e an d maintai n th e device . I f yo u have an yquestion s o rconcern s pleas e qualifie d representative , o rSeQua l Technologie s Inc . 

### WARNIN G PROTEC TTH E SARO S AN D TH E A C POWE R ADAPTE R AN D 2 4 VD C CABL E FRO M AL L FLUI D SPILL S O R FLUI D DRIP S TO AVOI D POSSIBL E SHOC KHAZARDS . 

### CAUTIO N ALWAY S CHEC KTHA TTH E AI R INLE TAN D TH E EXHAUS TVEN TO F TH E DEVIC E AR E NOT BLOCKE D AN D THA TTH E AI R INLE TFILTE R I S CLEA N BEFOR E USIN G YOU R DEVICE .

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### POWERIN G O N YOU R SARO S

Th e SARO S come s complet e wit h th e concentrator , A C Powe rAdapter , 2 4 VD C Cable , Batter yan d extr a filters . Th e SARO S i s a lightweigh t portabl e an d stationar ysourc e o f supplementa l oxygen . Th e devic e i s capabl e o f bein g operate d directl yfro m thre e differen t powe rsources : 

### CONCENTRATO R 

# 1

Standar d Powe rSource s 

# jy^ ^ 

# r f ^

^S?*^H^^^ A C Powe rAdapte r

2 4 VD C Cabl e

Batter y



### GENERA L CHARGIN G INFORMATION : Th e SARO S charge s th e Batter ywhe n externa l powe r(A C o rDC ) i s presen t an d whe n th e Batter y temperatur e i s belo wa saf e chargin g temperature . Whe n externa l powe ri s disconnected , th e devic e wil l automaticall yswitc h ove rt o th e Battery , i f installe d an d charged . Whe n externa l powe ri s restored , b y pluggin g int o a n A C o rD C outlet , th e devic e wil l accep t powe rfro m th e externa l powe rsourc e an d recharg e th e Batter ywhil e operatin g th e devic e i f adequat e A C o rD C powe ri s available . 

### WARNIN G J2aji2 I TOUC H TH E POWE R CONNECTO R O N TH E BOTTO M O F TH E UNI TWIT H TH E BATTER Y REMOVE D AN D WHE N TH E DEVIC E I S CONNECTE D T O A N EXTERNA L A C O R D C POWE R SOURCE . (1 ) A C POWE R ADAPTER : Th e SARO S include s a universa l A C Powe rAdapte rfo rus e whereve r standar d A C powe ri s available . T o connec t t o a n A C powe rsource , b e sur e th e A C Powe rAdapte r devic e cor d i s securel yinserte d int o th e recesse d powe rreceptacl e o n th e to p o f th e devic e an d tha t th e A C powe rcor d fro m th e A C Powe rAdapte ri s plugge d int o a grounde d A C outlet . Whe n th e devic e i s plugge d i n properiy , th e Externa l Powe ri s Presen t Indicato rwil l appea ro n th e use rcontro l pane l i n Norma l Mode . 3 3 o f 8 9

### CAUTIO N

TH E A C POWE R CORD S USE D WIT H TH E SARO S MUS TMEE TTH E ELECTRICA L REQUIREMENT S O F TH E COUNTR YWHER E TH E DEVIC E I S USED . US E ONLYWIT H AGROUNDED , 3-PI N RECEPTACLE . D O NOTREMOV E TH E GROUNDIN G PI N FRO M TH E POWE R CORD . US E ONLYWIT H SEQUA L SUPPLIE D POWE R CORDS . (2 ) D C POWE R SUPPLY : A2 4 VD C Cabl e allow s th e syste m t o operat e fro m D C outlets , suc h a s thos e foun d i n vehicles . Star

t th e vehicle . Inser

t th e 2 4 VD C cabl e int o th e powe rreceptacl e o n th e to p o f th e device . Next , inser

t th e 2 4 VD C Cabl e plu g int o th e D C powe routle t i n you rvehicle . Whe n th e devic e i s properi yconnecte d an d receivin g powe rfro m th e D C powe rsource , a gree n indicato rligh t o n th e Externa l Powe ri s Presen t Indicator , o n th e contro l pane l wil l illuminat e i n Norma l Mode . 

### WARNIN G SECUR E TH E SARO S AN D TH E D C POWE R SUPPL YI N YOU R VEHICL E AN D B E SUR E THER E I S ADEQUAT E AI R FLO W T O TH E DEVIC E AN D THA TTH E AI R INLE TAN D EXHAUS TVENT S AR E NO TBLOCKED . BLOCKIN G O F TH E AI R INLE TO R EXHAUS TVEN TMA YIMPAI R DEVIC E PERFORMANCE . D O NOTLEAV E TH E SARO S O R 2 4 VD C CABL E PLUGGE D INT O TH E VEHICL E WITHOU TTH E ENGIN E RUNNIN G O R ATTEMP TT O STAR TTH E VEHICL E WHIL E TH E D C POWE R SUPPLYI S CONNECTE D T O TH E VEHICLE . DOIN G S O WIL L DRAI N TH E VEHICLE' S BATTERY . I F TH E VEHICLE' S D C POWE R SOURC E DROP S BELO W 11. 5 VOLT S (BROWNOU TCONDITION ) TH E SARO S WIL L REVER TT O BATTER YOPERATIO N I F TH E BATTER YI S PRESENT . 

## TYPICA L NE W BATTER YOPERATIN G TIM E Batter yOperatin g Time : Th e operatin g tim e o f th e Batter yi s displaye d o n th e use rcontro l panel . A variet yo f factors , suc h a s flo wsetting , Puls e o rContinuou s Flo wMode , temperatur e o rag e wil l impact th e operatin g time . Th e followin g tabl e provide s operatin g tim e estimate s fo rth e SARO S operatin g o n a full ycharge d Batter

ygive n certai n flo wsetting s an d nomina l operatin g conditions . CONTINUOU S FLO W SETTIN G (LPM ) 1. 0 2. 0 3. 0 CONTINUOU S FLO W H PULS E FLO W

BATTER YOPERATIN G • BATTER YOPERATIN G

TIM E m TIM E 1. 1 hour s H 1. 2 hour s 4 5 mi n H 1. 1 hour s 3 0 mi n H 5 3 mi n

H 4 7 mi n H 4 6 mi n H 3 7 mi n PULS E FLO W MOD E SETTIN G (ML ) 1 6 32 4 8 6 4 8 0 9 6 NOTE : Batter

yru n tim e wil l degrad e unde rhig h temperatur e us e an d a s th e batter ycell s age . 3

4 o f 8 9

### CAUTIO N

STOR E TH E BATTER YI N ACOO L AN D DRYLOCATION . THI S WIL L HEL P T O ASSUR E TH E LONGEVITYO F YOU R BATTERY . U.S . DEPARTMEN TO F TRANSPORTATIO N (DOT ) AN D UNITE D NATION S (UN ) REGULATION S REQUIR E TH E REMOVA L O F TH E BATTER YFRO M TH E DEVIC E FO R AL L INTERNATIONA L AIRLIN E TRAVE L WHE N TH E SARO S I S CHECKE D A S LUGGAGE.WHE N SHIPPIN G TH E SAROS , TH E BATTER YMUS TALS O B E REMOVE D FRO M TH E DEVIC E AN D PACKAGE D PROPERLY . QQJiQ I ATTEMP TT O OPE N TH E BATTERY ; THER E AR E N O SERVICEABL E PART S INSID E TH E BATTERY . ONLYREPLAC E TH E SEQUA L BATTER YSUPPLIE D WIT H TH E DEVIC E WIT H ASEQUA L BATTERY . RETUR N TH E BATTER YT O A N AUTHORIZE D SERVIC E CENTE R O R SEQUA L TECHNOLOGIE S FO R PROPE R DISPOSAL . D O NO TDISASSEMBLE , INCINERATE , O R HEATTH E BATTER YABOV E 140 ° F (60 ° C) . TH E BATTERY , USE D I N THI S DEVICE , MA YPRESEN TARIS KO F FIR E O R CHEMICA L BUR N I F MISTREATED . 

## TYPICA L BATTER YRECHARG E TIM E Th e typica l tim e t o recharg e you rBattery , i n orde rt o achiev e 80 % capacity , fro m a full ydischarge d Batter yi s 2. 4 hours . I f th e Batter

ybecome s to o war m durin g discharging , rechargin g wil l not begi n unti l th e Batter ysufficientl y cools . Removin g th e Batter yan d allowin g i t t o coo l mayexpedit e thi s coolin g process . 

## INITIA L BATTER YCHARGIN G Th e newBatter

ysupplie d wit h th e SARO S i s not full ycharge d whe n i t i s shippe d fro m th e factory . Pushin g th e Tes t Butto n o n th e Batter ywil l indicat e th e leve l of Charg e within . Befor e usin g th e SARO S fo rth e firs t time , full ycharg e th e Battery . Attac h th e Batter

ybyalignin g th e connecto ro n th e batter yt o th e matin g par

t o n th e botto m of th e SAROS . Th e Batter

ywil l clic k

int o place . Powe rth e SARO S ON , wit h th e A C Powe rAdapte rplugge d in , an d th e Batter ycorrectl yinstalled . Wit h th e devic e powere d ON , allo wth e Batter yt o completel ycharge . Th e Batter yi s full ycharge d whe n th e Batter yStatu s Gaug e Indicato ro n th e Contro l Pane l i s completel yilluminate d o rth e devic e ha s bee n chargin g fo ra minimu m of 5 hours . NOTE : Th e SARO S ca n b e use d whe n eithe rdischargin g o rrechargin g of th e Batter yi s takin g place . CAUTIO N D O NOTLEAV E TH E SAROS , O R BATTERY , I N TH E SEATIN G ARE AO F AMOTO R VEHICL E O R I N TH E TRUN KO F AMOTO R VEHICL E DURIN G AHO TDAY . NOTE : TH E STORAG E TEMPERATUR E RANG E FO R TH E DEVIC E I S -4° F (-20°C ) T O +140 ^ (+60°C ) AN D 95 % NON-CONDENSIN G HUMIDITY . 3 5 of 8 9I n th e even t o f a n externa l powe rinterruption , th e SARO S wil l automaticall yswitc h t o th e Batter y operation . Whe n externa l powe ri s restored , th e Batterywil l automaticall ystart recharging . I f th e Batteryi s no t present , o rfull ydischarged , during a n externa l powe rinterruption , th e SARO S wil l shu t down . 

## LO W BATTER YALERT S Th e tabl e belo wdescribe s th e LC D Displa yan d Alar m fo rLowBatter yConditions . MINIMU M REMAININ G TIM E O N BATTER Y Tim e Remainin g (Min ) Batter yIco n Alar m < 6 Minute s Flas h Flas h O N 1 2 Minute s <X < 1 5 Minute s Flas h Soli d OF F > 1 5 Minute s Soli d Soli d OF F NOTE : Pres s an d hol d th e Utilit yButto n fo ran d thi s wil l silenc e th e Los s o f Powe ralar m fo r2 minutes . Connectin g th e SARO S t o a n externa l A C powe rsuppl ywil l als o eliminat e thi s alarm . Whe n replacin g th e Batter ywithou t th e devic e bein g externall ypowered , pus h th e ON/OF F (Standby ) t o restar t th e SAROS . 

## BATTER YINSTALLATIO N ONT O SARO S 1 . Pres s th e Latchin g Pi n Releas e Butto n inwar d o n th e botto m of th e Batter yprio rt o installin g ont o th e SAROS . 2 . Inser t th e Batter

yont o th e SARO S byalignin g th e Batter yConnecto rof th e Batter yint o th e connecto r openin g at th e botto m of th e unit . Batter yi s properi yengage d whe n th e latc h pi n i s snappe d int o place .



### Batter y Connecto r

o f SARO S

3 6 o f 8 9

## OPERATIN G YOU R SARO S FO R TH E FIRS TTIM E

ste p 1 : Locatin g you rSAROS . Plac e th e SARO S i n a well-ventilate d area . B e sur e th e ai rinle t an d exhaus t ven t ar e no t obstructed . Positio n th e SARO S s o al l audibl e an d visua l indicator s o ralarm s ca n b e easil ysee n an d heard . Connec t th e A C Powe rAdapte rt o Externa l Powe rReceptacl e locate d o n to p o f th e devic e an d plu g th e devic e int o a grounde d A C Powe routlet , connec t t o a D C Powe rsourc e wit h th e 2 4 VD C Cable , o rb e sur e ther e i s a full ycharge d Batter yinstalled . Ste p 2 : Powe rO N th e Devic e an d allo wi t t o War m U p Oxyge n Monitorin g - Th e SARO S ha s a n oxyge n concentratio n statu s indicato r(OCSI ) built-i n t o th e device . Th e OCS I continuall ymonitor s th e oxyge n outpu t o f th e device . Pres s an d hol d th e "ON/OFF " Butto n t o powe rO N you rSAROS . Th e SARO S wil l star t u p i n Tactica l Mod e an d Continuou s Flo wo f 3 LPM . Allo wu p t o fiv e (5 ) minute s fo rth e devic e t o reac h it s performanc e specifications . I f th e devic e fail s t o reac h it s performanc e specification s afte r5 minutes , th e uni t wil l alar m accordin g t o th e mod e i t i s in . Ste p 3 : CONNEC TTH E OXYGE N SUPPL YTUBIN G T O TH E OXYGEN . Clea n an d Replac e th e cannul a an d oxyge n suppl ytubin g regulariy , a s recommende d b yth e Manufacturers ' Instructions . Ste p 4 : SELEC TTH E FLO W DELIVER YMOD E Pres s th e Flo wMod e butto n t o selec t th e desire d flo wmod e - Continuou s o rPulse . Pressin g thi s butto n repeatedl ywil l toggl e yo u bac k an d fort h betwee n th e flo wmodes . Whe n operatin g i n th e Continuou s Flo wMode , a continuou s suppl yo f oxyge n measure d i n liter s pe r minut e (LPM ) wil l flo wfro m th e Oxyge n Outle t Port . 

### WARNIN G D O NO TUS E SUPPL YTUBIN G O R CANNUL AEXTENSION S THA TAR E MOR E THA N 50 ' (15.2M ) I N LENGT H I N TH E CONTINUOU S FLO W MODE . PULS E FLO W MOD E OPERATION : Whe n operatin g i n Puls e Flo wMod e an d ther e i s n o inspirator yeffort detecte d b yth e devic e afte r6 0 second s tota l time , th e devic e wil l switc h t o th e Continuou s Flo wMod e an d wil l produc e a t a n equivalen t minut e volume . Th e aler t wil l ceas e a t thi s time . Whe n operatin g i n Puls e Flo wMode , a bolu s o f oxyge n measure d i n m L wil l b e delivere d fro m th e Oxyge n Outle t Port , eac h tim e a n inspirator yeffort , o rnegativ e pressure , i s detected .

3 7 o f 8 9PULS E FLO W MOD E FEATURES :

Th e SARO S Puls e Flo wMod e deliver s a hig h flo woxyge n bolu s a t th e beginnin g o f eac h inspiration . You rSARO S Puls e Flo wMod e ha s a feature , calle d autoSAT TM Technolog yan d a Puls e Flo wMod e Sensitivit ySettin g t o easil ytrigge rth e oxyge n bolu s delivery . Thes e feature s ar e provide d t o ensur e tha t patient s ca n easil ytrigge ra deliver yo f a n oxyge n bolu s an d tha t th e oxyge n bolu s maintain s consistenc yove rhighe rbreat h rates . autoSAT TM Technolog yprovide s a consisten t bolu s volum e o f oxyge n a s a patients ' breat h rat e increases . Puls e Settin g Bolu s Siz e (+/-15% ) 1 6 3 2 4 8 6 4 8 0 9 6 Maximu m Breat h Pe r

Minut e (bpm ) 4 0 4 0 4 0 4 0 3 7 3 1 NOTE : Bolu s volum e decrease s a s breat h rat e exceed s publishe d range . Th e Puls e Flo wSensitivit y( P SENS ) ca n b e adjuste d i n th e Utilit yMen u fro m 1 - 3 . Asettin g o f 1 i s th e mos t sensitiv e an d a settin g o f 3 i s th e least . 

### WARNIN G PULS E FLO W MOD E SETTING S MUS TB E DETERMINE D FO R EAC H PATIEN TINDIVIDUALLY . SETTING S USE D I N TH E CONTINUOU S FLO W MOD E MA YNO TAPPLY , O R B E APPROPRIATE , I N TH E PULS E FLO W MOD E AN D VIC E VERSA . A S WIT H AL L OXYGEN-CONSERVIN G TYP E DEVICES , TH E SARO S MA YNO TB E ABL E T O DETEC TAL L INSPIRATOR YEFFORT S I N TH E PULS E FLO W MODE . Ste p 5 : ADJUS TTH E FLO W SETTIN G T O TH E PRESCRIBE D LEVE L Usin g th e Flo wSettin g Buttons , adjus t th e flo wsettin g t o th e prescribe d setting . Ste p 6 : SELEC TUSE R DEFINABL E SETTING S USIN G TH E UTILIT YMEN U Th e Utilit yMen u ha s th e feature s tha t ca n b e adjuste d b yth e use ro rinformatio n fo rth e use ro rServic e Technician . Belo war e th e feature s o f th e Utilit yButto n an d th e Utilit yMenu :

• Pressin g th e Utilit ybutto n wil l tur n of f th e audi o alar m fo r11 9 second s unles s thi s i s prevente d b y a malfunction . • Th e Utilit yMen u mod e ca n b e entere d wheneve rth e uni t ha s powe r(Standb yo rON ) o r9 V Battery . • Eac h tim e th e Utilit yButto n i s pressed , th e Utilit ymen u wil l advanc e t o th e nex t option . • Th e option s withi n th e Utilit yMen u ca n b e change d b yusin g th e Increas e an d Decreas e buttons . • Pressin g th e Flo wMod e butto n i n th e Utilit yMen u goe s bac k t o th e previou s Utilit ymen u item . • Th e Utilit yMen u wil l rever t bac k t o th e previou s displa ymod e afte r5 seconds . • Pressin g an d holdin g th e Utilit ybutto n fo ra t leas t 1 0 second s wil l rese t th e SAROS . T o restart , pres s an d hol d ON/OF F (Standby ) button . • Th e firs t men u ite m t o appea ri s Tactica l Mod e O n / Off . 3 8 o f 8 9Th e followin g sequenc e o f screen s shal l b e displaye d o n th e LC D whe n th e Utilit yMen u i s displayed .

Tactica l Mod e O n /

Of f selection : Format : TACT=O N Tactica l mod e i s O N Format : TACT=OF F Norma l mod e i s O N Alar m Codes : Format : AC^XXX X Se e Alar m Cod e Tabl e definitions . Whe n mor e tha n on e alar m cod e i s present , pressin g th e Increas e ke ywil l sho wth e nex t highes t priorit ycod e an d pressin g th e Decreas e ke ywil l sho wth e nex t lowes t priorit ycode . Puls e Sensitivit y Format : P SEN S = X (wher e X i s th e valu e o f 1 thr u 3 ) LC D Contras t Format : LC D C T= X (wher e X i s th e valu e fro m 1 thr u 6 ) Tactica l Volum e Format : TVOL= X (wher e X i s th e valu e fro m 0 thr u 6 ) Tactica l Brightness : Forma t TBRT = X (wher e X i s 0 thr u 6 ) Select s th e LE D an d LC D backligh t Ligh t intensit yuse d i n Tactica l Mode . Norma l Mod e Brightness : Forma t N BR T= X (wher e X i s 1 thr u 6 ) Select s th e LE D an d LC D backligh t Ligh t intensit yuse d i n Norma l Mode . 9 V Batter yStatus : Format : 9 V = GOO D Batter yi s goo d Format : 9 V = RPL C Replac e 9 vbatter y Hour s o f Operatio n Format : HR = XXXX X Syste m Softwar e Par t Numbe ran d Revision : Format : SPPP P M m (wher e SPPP P = Syste m Softwar e Par t Number , M = Majo rVersion , an d m mino rVersion ) Moto rSoftwar e Par t Numbe ran d Revision : Format : MPPP P M m (wher e MPPP P = Moto rSoftwar e Par t Number , M = Majo rVersion , an d m mino rVersion ) Ste p 7 : BEGI N USIN G YOU R SARO S NOTE : Yo u wil l achiev e longe roperatin g tim e o n th e Batter yi f yo u operat e i n th e Puls e Flo wMode . Ste p 8 : POWE R OF F TH E DEVIC E Pres s an d hol d th e "ON/OFF " Standb yButto n fo rtw o (2 ) second s t o powe rOF F you rSAROS . Stor e th e SARO S i n a coo l an d dr ylocation . 3 9 o f 8 9

# Alerts , Alarms , an d Troubleshootin g Tabl e

Th e table s sho wth e possibl e audibl e an d visua l alert s an d alarms , thei rcondition s an d sugges t appropriat e troubleshootin g responses . I f yo u ar e unsur e abou t an yalert s o ralar m conditions , o r response s pleas e contac t a n authorize d servic e technicia n o rg o t o www.sequal.com . Alar m level s Typ e Hig h Alar m Me d Alar m Lo w Alar m Statu s Leve l

0 1 2 3 Gree n

LE D OF F OF F OF F O N Yello w

LE D OF F Blin k Blin k OF F Re d LE D

O N OF F OF F OF F Audi o Alar m

O N (ma yshutdow n electronic s afte r 1 0 seconds ) 2 beep s ever y 11 9 se c 1 bee p ever y 119 s OF F LC D

Flashin g sta r replace s To r N Flashin g sta r replace s To r N Flashin g sta r replace s To r N N C Descriptio n

Malfunctio n Attentio n i s require d Attentio n i s require d Al l O K 

### NC = N o Chang e WARNIN G AVAILABILIT YO F ABACK-U P SOURC E O F OXYGE N I S RECOMMENDE D I N CAS E O F POWE R OUTAG E O R ADEVIC E FAILURE . CONSULTYOU R PROVIDE R FO R BACK-U P OXYGE N SYSTEM . D O NOTIgnor e Alarms . Syste m wil l attemp t t o produc e oxyge n unde rfaul t conditio n bu t maynot b e a t purityo rflow .

4 0 o f 8 9

### SYSTE M TROUBLESHOOTIN G GUID E S YMPTO M SARO S doe s no t powe ro n

whe n ON/OF F butto n i s presse d

N o Oxyge n

Lo wOxyge n Concentratio n

Lo wOxyge n Flo w

N o Oxyge n delivere d i n Puls e Flo wMod e 

### PROBABL E CAUS E N o Batter yinstalle d Batter yi s discharge d o rn o externa l

powe ri s presen t Othe r Ai rInle t o rHEP AFilte rBlocke d

Humidifie r SARO S no t O N Tubin g o rcannul a i s no t properi y connecte d o ri s kinke d

Othe r Restrictio n i n tubin g o rhumidifie r Ai rInle t o rHEP AFilte rrestricte d Inadequat e Ventilatio n Othe r Restrictio n i n humidifie ro rtubin g Ai rInle t o rHEP AFilte rBlocke d

Othe r Tubing/cannul a longe rtha n 7 fee t (2.1m ) Humidifie rattache d N o inspiratio n detecte d 

### REMED Y Instal l Batter yo rplu g int o externa l

powe r Plu g int o externa l powe r Contac t a n authorize d Servic e

Technicia n Clea n Ai rInle t Filte ro rreplac e

HEP AFilte r Chec k humidifie rattachmen t an d tubin g Powe rSARO S O N Chec k tubing , cannul a an d connection s Contac t a n authorize d Servic e

Technicia n Repai ro rreplac e tubin g o r humidifier . Plac e you rSARO S s o ther e i s adequat e ai rflow . Clea n ai rinle t filte ro rreplac e HEP A Filter . Plac e you rSARO S s o ther e i s

adequat e ai rflow . Plac e you rSARO S s o tha t ther e i s adequat e ai rflow , i.e . no t covere d b ya blanke t o ra poncho . Contac t a n authorize d Servic e

Technicia n Repai ro rreplac e humidifie ro r

tubin g Clea n Ai rInle t Filte ro rreplac e

HEP AFilte r Contac t a n authorize d Servic e

Technicia n Attac h 7 foo t (2.1m ) tubing/cannul a

Remov e humidifie r Contac t a n authorize d Servic e

Technicia n

4 1 o f 8 9

### S YMPTO M Batter yStatu s Gaug e neve r indicate s full ycharge d Hea t relate d failures , i.e . Compresso rto o ho t Batter ywil l no t latc h ont o

SARO S Oxyge n productio n i s limite d du e t o powe rlimitation s 

### PROBABL E CAUS E Batter yi s agin g Ambien t conditio n i s to o ho t Batter yLatchin g Pi n Releas e i s stuc k i n th e wron g positio n Externa l powe rsourc e canno t suppl yenoug h powe r 

### REMED Y Contac t a n authorize d Servic e

Technicia n t o replac e Batter y Plac e uni t i n coo l environmen t o rou t o f direc t sunlight , i f possible . Pres s th e Latchin g Pi n Releas e Butto n inwar d t o fre e th e latc h mechanis m an d re-instal l Batter y Chec k ai rinle t filte ran d chec k th e externa l powe rsourc e

4 2 o f 8 9

# SARO S Optiona l Accessorie s

Visi t u s a t www.sequal.co m fo rmor e informatio n abou t optiona l accessories . Ther e ar e man ydifferen t type s o f oxyge n tubing , cannula , an d humidifiers . Th e followin g item s ar e recommende d b ySeQua l Technologie s fo rus e wit h you rSAROS . Salte rLabs ®

Humidifier , Par t Numbe r7600 , o requivalent : I f a n optiona l humidifie ri s prescribed , follo w th e manufacturer' s instruction s fo ruse . Attac h th e humidifie rt o th e oxyge n outle t por t o f th e SAROS . Us e o f optiona l humidifier s no t recommende d fo rth e SARO S ma yimpai rperformanc e o f th e devic e an d ma y voi d th e warranty . D O NO Tus e a humidifie ri n th e Puls e Flo wMode . Th e SARO S wil l no t detec t inspirator yeffort . Th e devic e wil l alar m an d defaul t t o th e Continuou s Flo wMod e fo rcontinuin g operation . SeQua l Technologie s Humidifie rAdapte r- Par t Numbe r3509 : I f prescribe d a n optiona l humidifie ri s prescribed , us e th e SeQua l Humidifie rAdapter . Follo wth e instruction s fo ruse . Attac h th e Humidifie r Adapte rt o th e oxyge n outle t por t o f th e SARO S an d the n t o th e humidifier . Attac h th e cannula , o roxyge n tubin g t o th e humidifie routlet . Salte rLab s Oxyge n Suppl yTubing , Par t Numbe rSerie s 2000 , o requivalent : Th e interna l diamete r shoul d b e n o les s tha n 3/16 " (0.4 8 cm) . Connec t th e oxyge n tubin g t o th e outle t por t o f th e humidifie ro r directl yt o th e oxyge n outle t por t o f th e SARO S i f yo u d o no t us e a humidifier . Connec t th e othe ren d o f th e tub e t o th e nasa l cannula , i f oxyge n suppl ytubin g i s no t alread yattache d t o th e cannula . Tubin g no t specifie d fo rus e wit h thi s SARO S ma yimpai rth e performanc e o f th e device . WARNIN G TH E TUB E FITTIN G MA YB E TIGH T- D O NO TUS E OIL S O R GREAS E T O LUBRICAT E TUBIN G O R OXYGE N OUTLE TPORT . I F TUBIN G BECOME S DISCONNECTE D DURIN G OPERATION , TH E SARO S DOE S NO TALARM . CHEC KFLO W A TTH E CANNUL AT O VERIF YOXYGE N DELIVERY . Salte rLab s Oxyge n Cannula , Par t Numbe r160 0 Series , o requivalent : Acannul a i s typicall yuse d t o delive roxyge n t o th e patient . I n mos t case s the yar e alread yattache d t o th e oxyge n tubing . I f not , follo w th e instruction s include d wit h th e cannul a t o attac h i t t o th e oxyge n tubing . Us e o f a n oxyge n cannul a no t specifie d fo rus e wit h thi s SARO S ma yimpai rth e performanc e o f th e device . WARNIN G US E O F A N OXYGE N MAS KI S CONTRAINDICATE D DU E T O TH E POSSIBILIT YO F REBREATHIN G EXHALE D CARBO N DIOXIDE .

4 3 o f 8 9

# Cleaning , Car e an d Routin e Maintenanc e

ROUTIN E MAINTENANC E Servicin g o f th e interna l component s o f thi s devic e mus t b e conducte d b ya traine d an d qualifie d servic e technician . Aqualifie d technicia n wil l perfor m inspection s an d maintenanc e o f th e compressor , alarms , interna l 9 vol t battery , Batter yan d othe rpart s onl ya s needed . 

### WARNIN G D O NO TDISASSEMBL E TH E SARO S O R ATTEMP TT O PERFOR M AN YMAINTENANC E TASK S OTHE R THA N THOS E DESCRIBE D I N TH E USE R CAR E AN D CLEANIN G O F TH E DEVIC E SECTIO N BELOW . DISASSEMBLIN G TH E SARO S MA YCREAT E A N ELECTRICA L SHOC KHAZAR D AN D WIL L VOI D YOU R WARRANTY . CONTAC TAQUALIFIE D TECHNICIA N FO R AN YINSPECTION , MAINTENANCE , O R REPAI R REQUIRED . 

# USE R CAR E AN D CLEANIN G O F TH E DEVIC E Cannul a Replacement : Clea n an d Replac e you rsuppl ytubin g an d cannul a o n a regula rbasi s a s recommende d b yth e manufacturer' s instructions . Ai rInle t Filter : Ambien t ai ri s draw n int o th e devic e throug h th e ai rinle t locate d o n th e to p o f th e device . Cleanin g th e ai rinle t filte ri s th e mos t importan t maintenanc e activit yt o kee p you rSARO S performin g properiy . Chec k

thi s ai rinle t filte rdail yan d clea n i t a t leas t onc e a wee k usin g th e followin g procedure : 1 . Remov e th e fou rscrew s o n th e Cove ro n th e to p o f th e devic e an d remov e th e ai rinle t filter . 2 . Was h th e filte ri n war m ta p water ; 3 . Allo wth e filte rt o ai rdry ; 4 . Reinser t th e filte ri n th e locatio n i t wa s removed ; 5 . Cleanin o ti p - kee p a clea n secon d filte ra s a replacemen t fo rus e whe n on e filte ri s drying . CAUTIO N TH E AI R INLE TFILTE R SHOUL D B E FRE E O F LIQUI D WATE R AN D DR YT O TH E TOUC H BEFOR E REINSTALLATION . EXCES S MOISTUR E I N TH E FILTE R MA YIMPAI R TH E PROPE R OPERATIO N O F TH E SAROS . Th e ai rinle t filte rshoul d b e replace d a s needed . I f th e SARO S i s use d i n a dust yenvironment , th e filte r ma ynee d t o b e replace d mor e often . A C Powe rAdapter , 2 4 VD C Cabl e an d Powe rCord : Tur n OF F th e SARO S an d disconnec t fro m A C o r D C powe rbefor e an ycleanin g o rdisinfectio n activity . Us e a dam p (no t soakin g wet ) clot h o rsponge . Spra yth e clot h o rspong e wit h a mil d detergen t solutio n t o clea n th e exterio ran d powe rsupplies . T o disinfec t th e SARO S us e Lysol ® Bran d I I disinfectant . Procee d a s directe d b yth e manufacturer .

4 4 o f 8 9WARNIN G

UNPLU G POWE R CORDS , A C O R D C POWE R SUPPLIE S BEFOR E CLEANIN G TH E EXTERIOR . D O NOTUS E DENATURE D ALCOHO L O R APPL YLIQUI D SPRAYO R AEROSO L CLEANER S T O TH E CORD S O R POWE R SUPPLIES . Optiona l Humidifier : I f used , clea n th e humidifie rdail yt o reduc e th e possibilit yo f contamination . Follo w th e cleanin g recommendation s byth e manufacture rof th e humidifier . Replac e th e humidifie rmonthly , o r a s recommende d b yth e manufacturer . 

# Batter yCleaning , Car e an d Maintenanc e Th e Batter

yi n th e SARO S require s specia l car e t o assur e a longe rlif e an d th e highes t leve l of performance . Th e SeQua l Batter yi s th e onl yapprove d Batter yrecommende d fo rus e wit h th e SAROS . Us e a dam p (no t soakin g wet ) clot h o rsponge . Firs t spra yth e clot h o rspong e wit h a mil d detergen t an d the n clea n th e Batter

ycas e an d th e latch . Batter yDisposal : You rBatter yi s rechargeabl e an d ca n b e recycled . Alway s retur n i t t o a n authorize d servic e cente ro rSeQua l Technologie s fo rprope rdisposal . Yo u ca n als o contact you rloca l cityo rtow n office s fo rinstruction s o n prope rdisposa l o f th e Battery . Batter yStorage : You rBatter yshoul d b e store d i n a coo l an d dr ylocation .

4 5 o f 8 9INTRODUCTIO N - SERVIC E AN D REPAI R

Maintainin g th e SARO S wil l insur e longe rlif e an d highe rperformance . Periodi cmaintenanc e i s recommended . CAUTIO N 

# A Th e SARO S contain s electrostati csensitiv e components . D o

No t ope n o rhandl e excep t a t a stati cfre e workstation . D o no t remov e cove rwithou t ES D protection .

PERIODI C MAINTENANC E LIS T Perfor m th e followin g maintenanc e procedures , a s needed . Th e frequencyo f th e periodi cmaintenanc e shoul d b e base d o n th e environmen t i n whic h th e SARO S i s use d within . Chec k an d clea n th e ai rinle t screen . Replac e a s neede d Chec k Batter yvisuall yan d functionall ywhe n received . Replac e a s needed . Inspec t A C Powe rAdapter , 2 4 VD C Cabl e an d cord s fo rdamage . Replac e a s needed . Verifytha t th e A C Powe rAdapte ran d 2 4 VD C Cabl e operate s wit h th e SAROS . Chec k 9 V battery . Replac e i f needed . Chec k HEPAFilter . Replac e i f needed . Rea d an d recor d hou rmeter . Chec k flo wrate , purity . Puls e Mod e an d alar m functions .

4 6 o f 8 9MAINTENANC E PROCEDURE S

Th e followin g sectio n list s procedure s tha t ar e necessar yt o maintai n th e SAROS . Servic e shoul d onl yb e performe d b ya qualifie d technician . T o perfor m periodi cmaintenance , th e onl ytool s tha t shoul d b e necessar yare : # 1 o r# 2 Phillip s Screwdrive r Wire-cuttin g Plier s Smal l cabl e tie s 3/8 " ope n en d wrenc h ES D Ma t o rapprove d ES D syste m

REMOVIN G TH E AI R INLE TCOVE R 1 . Disconnec t powe rsupplie s an d remov e th e batter yi f connected . 2 . Usin g a Phillip s screwdriver , loose n th e fou rcaptiv e screw s show n i n figur e 1 . 3 . Remov e cover .

Figur e 1

4 7 o f 8 9REMOVIN G AN D CLEANING/REPLACIN G TH E AI R INLE TFILTE R 1 . Gentl yremov e th e filte rshow n i n figure s 2 an d 3 . 2 . I f th e filte ri s damaged , replace . 3 . Fo rcleaning , gentl ywas h wit h war m soap ywater . Allo wfilte rt o completel ydr ybefor e re installing . 4 . Re-instal l Ai rInle t Filter . 5 . Usin g a Phillip s screwdriver , re-attac h th e Cover . 6 . Initia l an d dat e th e Servic e an d Maintenanc e Record . CAUTIO N 

# A Operatin g th e SARO S wit h a clogge d ai rinle t filte rma yreduc e performanc e an d lea d t o syste m damag e o rprematur e failure .

Figur e 2

Figur e 3

4 8 o f 8 9REPLACIN G TH E 9 V BATTER Y 1 . Disconnect powe rsupplie s an d remov e externa l batter yi f connected . 2 . Usin g a Phillip s screwdriver , loose n th e fou rcaptiv e screw s show n i n figur e #1 . 3 . Remov e cover . 4 . Remov e 9 V batter

yfro m wher e show n i n figur e 4 . 5 . Disconnect an d replac e batter ya s show n i n figur e 5 . 6 . Usin g a Phillip s screwdriver , replac e th e Ai rInle t Cover . 7 . Initia l an d dat e th e Servic e an d Maintenanc e Record .

Figur e 5

4 9 o f 8 9REPLACIN G TH E HEP AFILTE R

1 . Disconnect al l powe rsupplie s includin g externa l Batter yi f connected . 2 . Usin g a 3/8 " ope n en d wrench , remov e th e O 2 Fitting/HEP AFilte rshow n i n figure s 6 & 7 . 3 . Unscre wth e HEP AFilte rfro m th e O 2 Fittin g a s show n i n figur e 8 . 4 . Replac e wit h ne wHEP AFilter . D o not ove rtighten . NOTE : Insure tha t th e 0-Ring s show n i n figur e 9 are positione d correctl ybefor e re-installation . 5 . Re-instal l th e 0 2 Fitting/HEP AFilter . D o not ove rtighten. 6 . Initia l an d dat e th e Servic e an d Maintenanc e Record .

Figur e 6 Figure 7

Figur e 8

5 0 o f 8 9TES TPROCEDURE S

SARO S PURIT

YAN D FLO W RAT E TES TPROCEDUR E - PREFERRE D METHO D I t i s recommende d tha t th e SARO S b e teste d fo roxyge n concentratio n an d flo wperformance . SeQua l recommende d tes t setu p i s show n o n th e followin g diagram . Oxyge n monitors mayo rmaynot hav e a n interna l pum p t o dra wsample s o f oxyge n t o b e measured . Placemen t o f th e oxyge n monito ri n th e tes t setu p depend s whethe rthe yhav e a n interna l pump . Onl yon e oxyge n monito ri s neede d though . A n oxyge n monito rsuc h a s Salte rLabs ' PRO 2 Chec k Elit e o requivalen t mayb e used . • Connect th e circui t pe rth e diagra m show n below . • Tur n th e concentrato ro n an d se t th e targe t flo wo n th e SARO S t o 3 LP M continuou s flow . • Allo wth e SARO S t o stabilize , ( a minimu m o f 5 minutes ) • Verifyth e O

2 concentratio n an d O

2 flo wrate s ar e withi n specification . 

### SARO S Unit Flo w Meter O 2 Monito r wit hPum p (Alternate location ) O 2 Monito r wit hPum p (preferre dlocation ) • 

### Ven t t o Atmosphere

Figur e 9 : SeQua l Recommende d Tes t Setu p t o verifyperformanc e o f Oxyge n Concentrato r 

### Th e SARO S oxyge n concentratio n an d flo wsenso rcanno t b e calibrate d i n th e field . I f yo u suspect tha t th e SARO S flo wan d oxyge n puritymeasuremen t i s ou t o f calibration , pleas e retur n i t t o SeQua l fo rservice . PURIT YAN D FLOW RAT E PROCEDUR E - ALTERNAT E METHO D Attac h a calibrate d oxyge n monito rt o th e oxyge n outle t por t i n accordanc e wit h oxyge n monito r manufacturer' s recommendations . NOTE : 

### Som e sensin g equipmen t mayrestrict th e actua l flo wrat e belo wwha t

th e SARO S ca n provid e an d provid e inaccurat e concentratio n readings . I f testin g i s performe d wit h th e oxyge n monito ri n th e alternat e locatio n picture d above , ensur e tha t th e oxyge n monito rdoe s no t significantl yrestrict oxyge n flow . 5 1 of 8 9

### RECOR D HOUR S O F OPERATIO NAND SOFTWAR E VERSIO N T o hel p maintai n th e SAROS , yo u ma yobtai n th e Tota l Hour s o f Operatio n an d softwar e versio n number s fo rth e Contro l Board .

T o obtai n syste m information , follo w thes e steps : Pres s th e "Utility " Butto n o n th e contro l pane l an d advanc e t o th e followin g displa ymod e fo reac h tim e th e ico n i s depressed : Tactica l Mod e Alar m Cod e Puls e Sensitivit y LC D Contras t Tactica l Volum e Tactica l Brightnes s Norma l Brightnes s 9-vol t Batter yStatu s Hou ro f Operatio n Syste m Softwar e Versio n Moto rSoftwar e Versio n Figur e 9 : Dat a Outpu t For m Alar m Cod e Puls e Sensitivit y LC D Contras t Tactica l Volum e Tactica l Brightnes s Norma l Brightnes s 9-Vol t Batter y Statu s Hou rMete r Syste m Softwar e Versio n Moto rSoftwar e Versio n -- / ' • - '1- ^ ~ ~

-

•

Lo g th e Result s

5 2 o f 8 9ELECTRICA L SAFET YTES T T o tes t th e basi celectrica l safet yof th e SARO S A C Powe rAdapter , SeQua l recommend s usin g a n LKG 60 1 Electrica l SafetyAnalyze r(NeTec h Corporation , Hicksville , NY) o requivalen t t o verifytha t th e curren t leakag e t o groun d i s withi n appropriat e limits . Thi s i s require d fo rth e SARO S Oxyge n Syste m tha t utilize s th e Hospita l Grad e Powe rCord . 1 . 2 . 3 . 4 . 5 . Plu g th e A C Powe rAdapte rint o th e electrica l safet yanalyzer . Disconnect th e A C Powe rAdapte r fro m th e SARO S unit . Plu g th e safet yanalyze rint o a wal l outlet . Follo wth e analyze rmanufacturer' s instruction s fo rmeasurin g bot h th e forwar d an d revers e eart h leakag e curren t only . Verifytha t th e fonft^ar d an d reverse-curren t leakag e t o groun d i s </ = 250u a (100/115VA C applications ) an d </ = 50 0 u s (200/240VA C applications) . Disconnect th e A C Powe rAdapte rfro m th e electrica l safet yanalyzer . I f th e A C Powe rAdapte rmeasure s leakag e curren t greate rtha n th e criteri a i n ste p 3 , pleas e retur n i t t o SeQua l fo rservice . CLEANIN G TH E SARO S Us e mil d detergen t solutio n t o clea n th e sleeve , contro l pane l an d powe rsupplies . Tur n OF F th e SARO S an d disconnect fro m A C o rD C powe rbefor e an ycleanin g o rdisinfectio n activity . D O NOTsprayth e sleeve , contro l pane l o rpowe rsupplies . Us e a dam p (no t soakin g wet ) clot h o rsponge . Sprayth e clot h o rspong e wit h mil d detergen t solutio n t o clea n th e sleeve , contro l pane l o rpowe rsupplies . T o disinfect th e SAROS , us e Lyso l Bran d I I disinfectant . Procee d a s directe d b yth e manufacturer .

WARNING : Unplu g Powe rCords , A C o rD C Powe rSupplie s befor e

cleanin g th e exterio rcabinet . D O NO Tus e denature d alcoho l o rappl yliqui d spra yo raeroso l cleaners .

5 3 of 8 9

### SERVIC E AN D MAINTENANC E RECOR D

Wheneve rmaintenanc e o rservic e i s performe d o n a n SARO S unit , a n entr yshoul d b e mad e i n th e servic e lo g fo rtha t concentrato ro rrecorde d i n accordanc e wit h you rcompany' s standar d procedure . Wheneve rth e sleev e o f th e SARO S i s removed , th e flo wrate , purity , an d alar m statu s shoul d b e verifie d pe rth e Tes t Procedure s i n thi s manual .

SARO S Seria l Numbe r Dat e Hou rmete r

Readin g Initial s Servic e Performe d Purity Flo w Alarm s Comment s

Sampl e SARO S Maintenanc e Recor d

5 4 o f 8 9SHIPPIN G AN D TRANSPORTIN G TH E SARO S

Whe n shippin g th e SARO S us e origina l packagin g i f possible . Alway s remov e th e Batter yfro m th e SARO S befor e shipping . I f origina l packagin g materia l i s available , repac k th e SAROS , Batter

yan d powe rsupplie s i n th e designate d packagin g area . I f origina l packagin g materia l o rothe rSeQua l authorize d shippin g containe ri s no t available , contact SeQua l fo rreplacemen t shippin g container . WARNING : 

# A D O NO Texpos e th e SARO S t o water . Th e SARO S enclosur e

doe s no t provid e protectio n agains t th e harmfu l effect s o f liqui d ingress . Electrica l shoc k o rdamag e t o th e uni t ma yresult . STORIN G TH E SARO S Heat an d humiditymaydegrad e th e performanc e o rseverel ydamag e th e SAROS . Stor e th e devic e i n a cool , dr yprotecte d are a awayfro m hig h temperatures , moistur e an d humidity . Remov e th e Batter ywhe n storin g th e device . DISCARDIN G BATTERY : Contact th e loca l city , tow n o rcountr yoffice s fo rinstruction s o n prope rdisposa l of th e Battery . Alternately , SeQua l mayb e contacte d fo rth e Batter ydisposal . SAROS : Loca l environmenta l law s mayprohibi t disposa l of electrica l and/o relectroni cequipmen t suc h a s th e SARO S an d A C Powe rAdapter . Contact th e loca l city , tow n o rcountr yoffice s fo rinstruction s o n prope rdisposa l o f electrica l o relectroni cequipment . Alternately , SeQua l mayb e contacte d fo rdisposa l information .

5 5 of 8 9Alar m Indication s an d Code s

Thi s tabl e i s arrange d accordingl yt o alar m priority . Descriptio n Externa l voltag e to o hig h

Los s o f Powe r

Missin g Powe r Produc t To o Ho t Compresso r To o Ho t Powe rBoar d To o Ho t Moto rDrive r Boar d To o Ho t

IP C Failur e

%0 2 < 70 % Ultrasoni c Failur e Compresso r Stal l Compresso r Temperatur e Senso rFailur e AT F Temperatur e Senso rFailur e Compresso r an d AT F Leve l

0

0

0 0 0

0 0

0

0 0 0 0 0 0 Audi o indicato r O N

O N

O N O N O N

O N O N

O N

O N O N O N O N O N O N Ext .

Powe r LE D (Is/Is )

N C

N C N C N C

N C N C

N C

N C N C N C N C N C N C Batter y Ico n N C

N C

N C N C N C

N C N C

N C

N C N C N C N C N C N C Alar m Cod e ACOO

400 0

401 0 A41 0 910 0

920 0 930 0

AOO O

040 0 A30 0 919 4 911 0 890 0 911 0 890 0 Descriptio n Thi s alar m shal l activat e whe n th e externa l voltag e i s greate rtha n 30V . 0 2 Productio n an d batter ychargin g shal l no t begi n an d th e electronic s shal l shu t dow n afte r1 0 seconds . Thi s alar m shal l activat e durin g productio n whe n th e syste m determine s tha t vali d powe r ha s bee n lost . 0 2 Productio n an d batter y chargin g shal l stop , an d th e electronic s shal l shu t dow n afte r1 0 seconds . Thi s alar m shal l activat e i f th e use rattempt s t o star t th e uni t whil e ther e i s n o usabl e powe r sourc e connected . 0 2 Productio n an d batter y chargin g shal l no t begi n an d th e electronic s shal l shu t dow n afte r1 0 seconds . Thi s alar m shal l activat e whe n th e produc t temperatur e exceed s 60°C . 0 2 productio n shal l sto p o rcanno t b e started . 0 2 productio n shal l sto p o rcanno t b e started . 0 2 productio n an d batter ychargin g shal l sto p o rcanno t b e started . Th e electronic s shal l shu t dow n afte r1 0 second s whe n o n batter ypower . Th e displa yshal l b e blanke d afte r1 0 second s whe n o n externa l power . 0 2 productio n an d batter ychargin g shal l sto p o rcanno t b e started . 0 2 productio n an d batter ychargin g shal l sto p o rcanno t b e started . Th e electronic s shal l shu t dow n afte r1 0 second s whe n o n batter ypower . Th e displa yshal l b e blanke d afte r1 0 second s whe n o n externa l power . Th e alar m shal l activat e onl ywhe n concentratio n ha s bee n les s tha n 70 % fo r mor e tha n 6 0 seconds . I t shal l clea r immediatel yi f th e concentratio n goe s abov e 70%.Th e uni t shal l continu e production . 0 2 productio n shal l sto p o rcanno t b e started . 0 2 productio n shal l sto p o rcanno t b e started . 0 2 productio n shal l continue . 0 2 productio n shal l continue . 0 2 productio n shal l sto p o rno t b e starte d dependin g o n 5 6 of 8 9Descriptio n

Temperatur e Senso rFailur e Produc t Pressur e Senso rFailur e Ambien t Pressur e Senso rFailur e Produc t Temperatur e Senso rFailur e Ambien t Temperatur e Senso rFailur e Produc t an d Ambien t Temperatur e Senso rFailur e Unabl e t o Achiev e o r Maintai n Produc t Tan k Pressur e Purit y Calibratio n Dat a Failur e Flo w Calibratio n Dat a Failur e Watchdo g Timeou t

Invali d Rese t

I/ O Por t Failur e

RA M Failur e Leve l

0 0 0 0 0

0 0 0

0

0

0

0 Audi o indicato r

O N O N O N O N O N

O N O N O N

O N

O N

O N

O N Ext .

Powe r LE D

N C N C N C N C N C

N C N C N C

N C

N C

N C

N C Batter y ico n

N C N C N C N C N C

N C N C N C

N C

N C

N C

N C Alar m Cod e

A10 0 ABOO A41 0 AB1 0 A41 0 AB1 0

A50 0 A60 0 A70 0

900 0

800 0

810 0

820 0 Descriptio n Compresso rTemperatur e Senso ran d AT F Temperatur e Senso rcondition . 0 2 productio n shal l stop . 0 2 productio n shal l continue . 0 2 productio n shal l continue . 0 2 productio n shal l continue . 0 2 productio n shal l sto p o rno t b e starte d dependin g o n Produc t Temperatur e Senso r an d Ambien t Temperatur e Senso rcondition .

0 2 productio n shal l stop . Th e uni t shal l produc e usin g defaul t data . Th e uni t shal l produc e usin g defaul t data . 0 2 productio n an d batter ychargin g shal l sto p o rcanno t b e started . Th e electronic s shal l shu t dow n withi n 1 5 second s whe n o n batter y power . Th e displa yshal l b e blanke d withi n 1 5 second s whe n o n externa l power . 0 2 productio n an d batter ychargin g shal l no t start . Th e electronic s shal l shu t dow n withi n 1 5 second s whe n o n batter ypower . Th e displa y shal l b e blanke d withi n 1 5 second s whe n o n externa l power . 0 2 productio n an d batter ychargin g shal l no t start . Th e electronic s shal l shu t dow n withi n 1 5 second s whe n o n batter ypower . Th e displa y shal l b e blanke d withi n 1 5 second s whe n o n externa l power . 0 2 Productio n an d batter ychargin g shal l stop . Th e electronic s shal l shu t dow n withi n 1 5 second s whe n o n batter ypower . Th e displa y shal l b e blanke d withi n 1 5 second s whe n o n externa l power .

5 7 o f 8 9Descriptio n

Progra m Memor yFailur e Batter yTo o Ho t SS I Requeste d Alar m Hig h Flo wLimite d b y Availabl e Powe r Puls e Mod e Disable d Batter y Communicatio n Erro r War m Batter y Batter yTo o Col d t o Us e Batter yTo o Col d t o Charg e Flo wRat e Erro r Canno t Charg e Batter y Lo wBatter y Lo w9 vol t batter y 70% < 0 2 <85 % Ke yStuc k

O n Leve l

0 0 0 Audi o indicato r

O N O N O N 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s Ext .

Powe r LE D

N C N C N C N C N C (Is/Is ) N C N C N C N C N C N C N C

N C N C Batter y

Ico n

N C (Is/Is ) N C N C N C (1s/1s ) (Is/Is ) (Is/Is ) (Is/Is )

N C (1s/1s ) (Is/Is )

N C

N C N C Alar m Cod e

831 0 951 0 FOOO 201 0 A20 0 950 0 953 0 95C 0 95C C

200 0 952 C

954 0

100 0

080 0 811 0 Descriptio n 0 2 Productio n an d batter ychargin g shal l stop . Th e electronic s shal l shu t dow n withi n 1 5 second s o n whe n o n batter ypower . Th e displa yshal l b e blanke d withi n 1 5 second s whe n o n externa l power . Batter yshal l no t b e charge d o rdischarged . Thi s i s a n alar m tes t an d shal l no t affec t operation . Thi s alar m shal l activat e whe n flo wi s limite d b yth e availabl e power . Thi s alar m shal l activat e whe n a breat h senso r malfunctio n i s detected . Th e syste m shal l no t ente rpuls e mode . Batter yshal l no t b e charge d o rdischarged . Th e batter yshal l no t b e charged . Th e batter yshal l no t b e charge d o r discharged . Th e batter yshal l no t b e charged . Th e alar m shal l activat e whe n th e differenc e betwee n th e desire d flo wrat e an d th e measure d flo wrat e exceed s 10 % fo ra minimu m duratio n o f 6 0 seconds . Thi s alar m shal l activat e i f syste m i s attemptin g t o charg e th e battery , bu t can' t d o so . Th e alar m shal l activat e whe n th e tim e remainin g o n batter yi s s 6 minutes . Th e alar m shal l ceas e whe n th e tim e remainin g i s > 1 2 minutes . Th e alar m shal l activat e whe n th e measure d voltag e i s les s tha n 6.5V , an d shal l remai n activ e unti l batter yvoltag e improve s significantl y(non-volatile) . Th e alar m shal l activat e onl ywhe n concentratio n ha s bee n les s tha n 85 % fo r mor e tha n 6 0 seconds . I t shal l clea r mmediatel yi f th e concentratio n goe s abov e 85% . Thi s alar m shal l activat e whe n a ke yi s activ e fo rgreate rtha n 7 seconds .

5 8 o f 8 9Descriptio n

Ru n Lo g Storag e Failur e Breat h Pressur e Senso rFailur e Powe rBoar d Thermisto r Failur e Moto rDrive r Boar d Thermisto r Failur e Batter y Thermisto r failur e Batter yChi p Thermisto r failur e EEPRO M Dat a Writ e Failur e Even t Lo g Storag e Failur e SS I Requeste d Alar m Mediu m Al l O K Initializatio n Leve l

3 3 Audi o indicato r 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s 2 beep s o f 0.5 s ever y 119 s OF F OF F Ext .

Powe r LE D N C N C N C N C N C N C N C N C N C N C N C Batter y Ico n N C N C N C N C (Is/Is ) (Is/Is ) N C N C N C N C N C Alar m Cod e 830 0 A21 0 921 0 931 0 955 0 656 0 840 0 832 0 F10 0 Non e Non e Descriptio n Productio n shal l continue . Batter ychargin g i f require d shal l continue . Th e alar m shal l activat e whe n a breat h pressur e senso rfailure . Productio n shal l continue . Batter ychargin g i f require d shal l continue . Productio n shal l continue . Batter ychargin g i f require d shal l continue . Th e syste m shal l no t us e th e batter yi f th e reporte d independen t batter ythermisto rvalu e i s > 433 Ko r< 222K . Th e syste m shal l no t us e th e batter yi f th e reporte d batter ychi p thermisto rvalu e i s > 433 Ko r< 250K . Productio n shal l continue . Batter ychargin g i f require d shal l continue . Productio n shal l continue . Batter ychargin g i f require d shal l continue . Thi s i s a n alar m tes t an d shal l no t affec t operation . Thi s indicatio n shal l exis t whe n n o alarm s ar e detected . Purit yalarm s shal l b e inhibite d durin g th e initializatio n period . D O NOTIgnor e Alarms , purityo rflow . Syste m wil l attemp t t o produc e oxyge n unde rfaul t conditio n bu t maynot b e a t

5 9 of 8 9

## SERVIC E AN D REPAI R PROCEDURE S CAUTIO N 

# A Th e SARO S contain s electrostati csensitiv e components . D o

No t ope n o rhandl e excep t a t a stati cfre e workstation . D o no t remov e cove rwithou t ES D protection . WARNIN G 

# A Whe n performin g Servic e an d Repai rprocedures :

• D O NOTtouc h expose d circuit s durin g th e maintenance . • D O NOTtouc h movin g parts .

6 0 o f 8 9Svste m Schematic s an d Diagram s

M f M.t,i-im * J 

# i f "-|-7l-V"- { Ok—f ! ^

—-ik^—r « 

# ih . i - - 

### • ] 

## •^iW ; l # I J 3 | ; (si ) I— i TC : \ rj£iSUr : 

### ...Hlr '-!- ] ^—[^ ^

Figur e 10 : SARO S Oxyge n Syste m Bloc k Diagra m fo OM-V 6 1 o f 8 9

### Inle t Ca p

Assembl y Compressor/Produc t Tan k Assembl y Batter yConnector/Cabl e Assembl y

PC B Assembl y AT F Assembl y Figur e 11 : Mai n Component s

6 2 o f 8 9ELECTRICA L CIRCUI T

REMOV E AN D REPLAC E TH E BATTER YCONNECTO R

1 . Remov e th e thre e screw s show n belo wan d remov e th e Batter yInterfac e Plate .

Figur e 12 : Remova l o f th e thre e BI P Screw s 2 . Detac h th e Batter yInterfac e Assembl yfro m th e Rai n Guar d b yremovin g th e tw o screw s show n below .

Figur e 13 : Remova l o f Batter yInterfac e Assembl yScrews .

6 3 o f 8 93 . Remov e Sleeve , Sleev e Gaske t an d Sleev e Alignmen t Rin g t o expos e wiring .

Figur e 1 4 Figur e 1 5

4 . Cu t an d remov e th e gree n tie s show n below . Cautio n mus t b e use d t o avoi d damagin g wiring .

GREE N 

## TIES

= O Figur e 16 : Gree n Ti e remova l

64 of 8 95 . Loose n th e fou rscrew s show n belo wan d remov e th e Ai rInle t Cove ran d th e Ai rInle t Filter .

Figur e 17 : Ai rInle t Cove ran d Scree n Remova l 6 . Remov e an d disconnect th e 9 V Batter yan d th e Filter. .

Filte r 9 V Batter y

Figur e 18 : 9 V Removal .

6 5 of 8 97 . Remov e th e thre e Inle t Ca p Mountin g screw s show n below . 

### Inle t Ca p Mountin g Screw s

Figur e 19 : Inle t Ca p Scre wRemova l 8 . Cu t gree n cabl e ti e an d disconnect th e Oxyge n Outle t Tub e show n below .

Figur e 20 : Oxyge n Outle t Tub e Disconnect .

6 6 of 8 99 . Remov e tap e fro m Fron t Pane l FlexCabl e an d al l tap e securin g th e Sleev e Alignmen t Rin g t o th e

Mountin g Rails . Disconnect th e Fron t Pane l Flexcable . ^jWi:-;5a.-, ' -: •



### Securin g Tap e

Figur e 20a : Fron t Pane l FlexCabl e Disconnect . 10 . Disconnect th e Thermisto rConnecto ran d 9 V Batter yConnector . 

### Thermisto r Connecto r 9V Batter y Connecto r

Figur e 20b : Thermisto rConnecto ran d 9V Batter yConnecto r

6 7 o f 8 911 . Loose n th e screw s show n belo wan d remov e th e wire s fo rth e Inle t Ca p Powe rConnector .

Disconnect th e Tub e show n an d remov e th e Inle t Cap .

Figur e 21 : Inle t Ca p Powe r Figur e 21a : Tub e Disconnect

12 . Remov e th e tw o bulkhea d wirin g grommet s show n i n th e tw o figure s below . 

### Bulkhea d Grommet s

Figur e 2 2 Figur e 2 3

6 8 o f 8 913 . Loose n th e screw s show n belo wan d disconnec t th e Batter yInterfac e mai n powe rwires .

Figur e 24 : Mai n Powe rWire s fo rBatter yInterface . 14 . Disconnec t wher e show n below .

Figur e 25 : Secondar yConnecto rfo rBatter yInterfac e 15 . Remov e Batter yInterfac e cable . 16 . Rout e wire s fo rne wBatter yInterfac e Cable . 17 . Connec t Secondar yConnector . 18 . Attac h Mai n Powe rWire s fo rBatter yInterface . 19 . Positio n wire s an d re-appl ybulkhea d wir e grommets . 20 . Attac h Inle t Ca p Powe rConnecto rwires . 21 . Connec t Oxyge n Outle t Tube . 22 . Attac h Inle t Ca p usin g thre e screws . Us e Loctit e 22 2 an d d o no t ove rtighte n th e screws . 23 . Attac h an d instal l 9 V Batter yan d attac h Fron t Pane l Fle xCable . 24 . Instal l Inle t Filte rScree n an d Inle t Filte rCover . 25 . Appl yCabl e Tie s t o properi yre-secur e th e wirin g remove d i n previou s steps . 26 . Replac e Sleev e usin g 2 Sleev e Gasket s an d 2 Sleev e Alignmen t Rings . 27 . Attac h Batter yInterfac e t o th e Rai n Guard . Us e Loctit e 22 2 an d d o no t ove rtighte n th e screws . 6 9 o f 8 928 . Attac h th e rai n Guar d t o th e Sleev e an d secur e wit h th e Batter yInterfac e Plate . Us e thre e screw s wit h Loctit e 222 . D o no t ove rtighte n Screws . 29 . Perfor m produc t test . Powe rConnecto rReplacemen t

1 . Perfor m step s 1- 3 an d 5-1 1 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter y Connector" . 2 . Remov e th e fou rscrew s show n belo wan d remov e th e Powe rConnector .



### Powe rConnecto r Screw s

Figur e 26 : Powe rConnecto rRemova l 3 . Instal l ne wPowe rConnector . Us e Loctit e 22 2 o n th e fou rmountin g screws . Replac e 0-Rin g i f necessary . 4 . Perfor m step s 20-2 9 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter y Connector" .

7 0 o f 8 9Use rPane l Replacemen t

1 . Perfor m step s 1-

3 an d 5-1 1 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter y Connector" .

2 . Pee l of

f th e Use rPane l a s show n i n th e figur e below .

Figur e 28 : Use rPane l Remova l

7 1 o f 8 93 . Clea n th e surfac e show n i n th e figur e belo wbefor e re-applyin g th e newUse rPanel .



### Clea n Surfac e

Figur e 29 : Surfac e Pre p fo rapplicatio n of Use rPane l

4 . Remov e th e PS Aprotectiv e cove rfro m th e newUse rPanel . Inser t th e FlexCabl e a s show n i n th e figur e below .

Figur e 31 : Inser t FlexCabl e 72 of 8 97 . Positio n an d appl yth e ne wUse rPane l a s show n i n th e figure s below . Pres s firml yo n th e entir e

surfac e o f th e ne wUse rPane l t o insur e tha t i t i s bonde d correctly .

Figur e 3 2 Figur e 3 3

5 . Reconnect th e smal l tube . 6 . Perfor m step s 20-2 9 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter y Connector" .

73 o f 8 9OXYGE N CIRCUI T

Remov e an d Replac e th e AT F Assembly . NOTE : Ther e ar cn o setviceabi e part s insid e th e AT F Module . L"^ o no i attemp t t o disassembl e o rmodif yth e ATF Module . 1 . Perfor m step s 1-1 1 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter yConnector " 2 . Cu t an d remov e th e gree n tie s show n below . Cautio n mus t b e use d t o avoi d damagin g wiring .

GREE N TIE S Figur e 34 : Gree n Ti e remova l 3 . Remov e th e thre e mountin g rai l screw s show n below . Se t asid e th e rail .

Figure 35 : Rai l Scre wRemova l

74 of 8 94 . Cu t an d remov e th e tw o gree n tie s show n below . Cautio n mus t b e use d t o avoi d damagin g th e tubing .



### Remov e Tie s

Figure 36 : Gree n Ti e Remova l 5 . Remov e th e clamp s show n below . Disconnect th e tube .

Figure 37 : Clam p Remova l

75 of 8 96 . Remov e thre e screw s fro m eac h o f th e mountin g rail s show n i n th e tw o figure s below . Remov e

securin g tap e an d rails .

Figur e 3 8

Figur e 3 9

7 6 of 8 97 . Disconnect th e AT F Moto rConnecto rfro m th e PC B wher e show n i n th e figur e below .

Figur e 40 : AT F Moto rPowe rDisconnect . 8 . Disconnect th e AT F Thermisto rConnecto rfro m th e PC B wher e show n i n th e figur e below .

7 7 of 8 9Figure 41 : AT F Thermisto rDisconnect

9 . Remov e th e AT F Bulkhea d an d se t aside . 

### AT F Bulkhea d

Figur e 4 2 10 . Separat e th e AT F Modul e fro m th e Compressor/Tan k Modul e a s show n i n th e figur e below . Do no t damag e th e hose s durin g separation .

Figur e 43 : AT F Modul e Separatio n 7 8 o f 8 911 . Remov e th e cap s fro m th e AT F Port s o n th e replacemen t unit . Positio n th e newAT F Uni t a s

show n i n figur e 4 3 abov e an d reattac h th e tw o hoses . Secur e joint s wit h clamp s o rcabl e ties . D o not us e oi l o rgreas e i f th e tubin g i s difficul t t o install .

Onc e th e hose s ar e disconnecte d fro m th e AT F Modul e th e AT F Modul e i s expose d t o th e atmosphere . Ca p th e AT F Modul e port s immediatel yi n orde rt o minimiz e exposur e t o debri s an d humidit ywhic h ma yresul t i n AT F Modul e damage .

D O NO Tuse s an ypetroleu m base d o rothe rlubricants . A spontaneou s an d violen t ignitio n ma yoccu ri f oil , greas e o rothe r petroleu m substance s com e int o contac t vx'it h oxyge n unde r pressure . Kee p thes e substance s awa yfro m th e oxyge n system , tubin g an d connection s an d an yothe roxyge n source .

Remov e cap s o n AT F port s ONL Ybefor e connectin g th e tubes . D O NO Tleav e th e port s ope n unles s read yt o instal l th e tubes . Als o plac e th e remove d cap s fro m th e ne wAT F an d plac e o n th e port s o f th e replace d ATF .

12 . Reattac h AT F Bulkhead . 13 . Reattac h th e tw o sid e rails . Us e Loctit e 22 2 o n th e si xscrews . 14 . Reconnect th e AT F Thermisto ran d AT F Moto rConnector s t o th e PCB . 15 . Reattac h tub e fro m th e Product Tan k t o th e ATF . Secur e wit h a gree n tie . 16 . Reattac h to p rai l usin g thre e screws . Appl yLoctit e 22 2 t o th e screws . 7 9 o f 8 917 . Perfor m step s 20-2 9 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter y Connector" . Remov e an d Replac e th e Compressor/Product Tank/Bulkhead s Assembly .

1 . Perfor m step s 1-1 0 fro m th e previou s sectio n title d "Remov e an d Replac e th e Batter yConnector " 2 . Perfor m step s 2- 9 fro m th e previou s sectio n title d "Remov e an d Replac e th e AT F Assembly" . 3 . Disconnect th e Compresso rThermisto rConnecto rshow n i n th e figur e below .

Figur e 44 : AT F Thermisto rConnecto r 4 . Disconnect th e Compresso rHal l Senso rConnecto rshow n i n th e figur e below .

Figur e 45 : Compresso rHal l Senso rConnecto r

8 0 of 8 95 . Disconnect th e Compresso rPowe rcable s a s show n i n th e figur e below .

Figur e 46 : Compresso rPowe rWire s 6 . Remov e th e Bulkhea d Gromme t show n i n th e figur e below .

Figur e 4 7

8 1 o f 8 97 . Disconnect th e Fa n Connecto rshow n i n th e figur e below .

Figur e 48 : Fa n Connecto r 8 . Cu t an d remov e th e gree n ti e show n i n th e figur e below . Disconnect product tube .

Figur e 4 9

8 2 o f 8 99 . Remov e th e tw o screw s show n below . Remov e rail .

Figur e 5 0

10 . Remov e th e tw o screw s show n below . Remov e rail .

Figur e 5 1

8 3 o f 8 911 . Remov e th e Compressor/Product Tank/Bulkhea d Assembl ya s show n below . Insure tha t n o wire s

catc h o n edge s whil e removin g th e assembly .

Figur e 5 2 12 . Cu t an d remov e th e tw o gree n tie s show n i n th e figur e below . Se t asid e remove d component s fo r reassembly .

Figur e 5 3 

### NOTE : Ther e ar e n o serviceabl e part s insid e th e Compressor/Produc t

Tank/Bulkhea d Assembly . D o no t attemp t t o disassembl e o r modif yth e Compressor/Produc t Tank/Bulkhea d Assembly . 84 of 8 913 . Attac h component s remove d fro m ste p 1 2 t o th e ne wCompressor/Product Tank/Bulkhea d Assembly .

Secur e wit h cabl e ties .

14 . Reattac h rai l remove d i n ste p 10 . Us e Loctit e 22 2 o n al l screws . 15 . Reattac h rai l remove d i n ste p 9 . Us e Loctit e 22 2 o n al l screws . 16 . Reattac h product tube . Secur e wit h a cabl e tie . 17 . Rout e al l wire s a s show n i n previou s steps . 18 . Reconnect al l connector s an d wire s t o PCB . 19 . Perfor m step s 20-2 9 fro m th e sectio n title d "Remov e an d Replac e th e Batter yConnector "

8 5 o

f 8 9PREVENTATIV E MAINTENANC E AN D REPLACEMEN TPART S

Preventativ e Maintenanc e Part s Descriptio n Ai rInle t Filte r 9 V Batter y 0 2 Fittin g HEP AFilte r Larg e HEP AFilte r0-Rin g Smal l HEP AFilte r0-Rin g SeQua l Par t Numbe r 979 8 925 7 976 4 976 5 925 0 925 1 Replacemen t Part s Lis t "#"''^^^^^^^^^^^^^MQa:*''4T'fTlV--''''^>"-""i-" ^ Loctit e 222M S Kapto n Tap e Tubin g Tubin g Cabl e Ti e Tubin g PC B Wir e Harnes s Assembl y Dow n Pip e Filter , Exhaus t Exhaus t Tub e Tube , Filte rt o Ca p Tube , Silicon e Compresso rModul e Assembl y 0-Rin g 0-Rin g Bar b Inle t Cove rAssembl y Foa m Battery , 9 V Lithiu m Tub e Tub e Fiberglas s Sleev e Scre w Guard , Rai n Muffle rTub e Muffle rAssembl y Sleev e , Alignmen t Rin g Ambien t ThermisterThermisto r AT F Wir e Harnes s ThermisterThermisto rAssembl y Pipe , AT F - Produc t Tan k Batter yRibbo n ii^S^uaSplNurriBer? ' '• - 140 5 269 6 SP325 5 405 6 696 8 698 1 920 1 921 8 922 1 922 6 922 7 SP923 4 SP924 0 925 0 925 1 925 4 SP925 5 925 6 925 7 SP926 8 SP927 3 928 0 929 1 929 2 SP931 1 SP931 4 931 5 932 1 932 2 932 4 934 2 SP934 8 8 6 of 8 9

# ^^^^^^^^^^^^^^^^^^^^^^^^^^^ H Doubl e Side d Tap e Tube , Muffle rt o Rai n Guar d Wir e Sleev e PCB AASS Y EXTERNA L BATTER YASSEMBL Y D C Cable , 24VDC , Omn i I I AT F MODUL E ASSEMBLY , OMN I I I Membran e Pane l Tub e Grommetin g CYLINDE R SLEEVE , COMPOSIT E Inle t Ca p Assembl y Inle t Ca p Assembl y Foa m ELECTRONIC S BRACKE T Fitting , Bar b Filte r Externa l Wir e Harnes s Fa n FA N ASS Y Fa n Bulkhea d MUFFLE R EXHAUS T STRUT , TO P STRUT , LEF T STRUT , RIGH T RAI N GUAR D COMPRESSO R BULKHEA D VIBRATIO N MOUN TBUSHIN G VIBRATIO N MOUN TRIGH T COMPRESSO R HOS E EXHAUS TFITTIN G COMPRESSO R INLE TFITTIN G BATTER YCA P Produc t Tube , AT F t o Produc t Inle t Scree n AT F MOUN T Silicon e Rubbe rTubin g 1/8 " ID , 1/4 " OD , 1/16 " Wall , Whit e Alu m Tubin g 1/4 " OD,.18 " ID , .035 " Thick , 6 * L AT F BULKHEA D Isolatio n Gromme t SLEEV E GASKE T AT F BULKHEA D Pus h Pi n Batter yInterfac e RecpticalReceptacl e Assembl y Wir e Harness , Backu p Batter y Produc t Tan k

Assembly y Gromme t Scre w 

# Hi^^H^it^urriMftl i 937 0 939 0 SP963 8 SP971 0 SP972 3 972 7 SP972 9 973 1 973 2 SP973 9 975 2 SP975 6 975 7 975 8 976 1 976 4 976 5 976 6 976 7 SP977 0 977 2 977 6 977 8 977 9 978 0 978 6 978 7 978 8 978 9 979 0 979 1 979 3 979 4 979 7 979 8 979 9 990 7 990 8 992 2 992 7 992 8 992 9 993 6 SP993 9 994 1 SP994 5 995 9 9203- 2 8 7 o f 8 9Alu m Tubin g 3/8 " OD,.1875 " ID , Blu e 

# '^^^^^^^^msmmM&murrib m 9908- 1 SHCSM3x 4 9910- 1 Socke t Hea d Ca p Scre wM3 x8m m 9910- 4 10 0 Pe g Fla t Hea d Phillip s Scre w300SS , 4-40 , 3/16 " L , 9912- 1 Pa n Hea d Phillip s Machin e Scre w4-4 0 Thread , 1-1/4 " 9913-1 0 4-4 0 Scre w 9913- 3 Pa n Hea d Phillip s Scre w6-3 2 Thread , 1/2 " Lengt h 9914- 6 0-Rin g 9916- 3 0-Rin g 9916- 4 8-3 2 P h Hea d Scre w 9926- 2 #2-5 6 X 1/4 " LP H Scre w 9960- 3 9960- 4

8 8 o f 8 9

### Manufacture d by : SeQua l Technologie s Inc . 1143 6 Sorrent o Valle yRoa d Sa n Diego , C A9212 1 US A Toil-Free : 1-800-826-461 0 i n th e U.S. ,

o r1-858-202-310 0 Toll-Fre e Fax : 877-786-994 3 Worldwide : www.sequal.co m

SeQual®, SAROS TM an d autoSat TM are trademarks of SeQua l Technologie s Inc. , Sa n Diego , C A9212 1 Salte rLabs

® i s a registere d mar k

of Salte rLabs , Arvin , C

A9230 3 Lysol ® i s a registere d trademar k o f Reckitt Benckiser , UK .

P/ N 970 5 Rev : ADRAF T

8 9 of 8 9EXHIBIT S 

# Co\^ l t 3 510(k ) Summar y OC T 2 0 200 9 Submitte r Information : Submitter : Contact : Phone : FAX : Date of Summary : Devic e Name : Proprietar y Name : Commo n Name : Classificatio n of

Device : Produc t Code : SeQua l Technologies , Inc . 1143 6 Sorrent

o Valle y Roa d Sa n Diego , C

A 9212 1 Bria n Jarrell , Director

of Qualit y an dRegulator

y (858)202-315 7 (858)558-191 5 June 11,200 9 OMN I 2 Oxyge n Syste m Oxyge n Concentrator Generator , Oxygen , Portabl e as per 2 1 CF R868.544 0 CA W Predicat e Devic e Equivalence : SeQua l Technologie s i s claiming substantia l equivalenc e t

o tli e following legally marketedpredicate device : KO I 393 1 - OMN

I Oxyge n System , Model 100

0 (aka : Eclips e Oxyge

n System ) Descriptio n o f Device : 

### Th e OMN I 2 Oxygen Syste

mi s a n oxyge n concentrator

tha t provide s u

p t o 3 LP M continuou s flo

w or i n puls e mode a

n oxygen bolu s of

up t o 9 6 m L(milli-Liter) . The OMN I 2 Oxygen Syste

mi s basedo

n pressure swing adsorptio n (PSA) principles . The OMN I 2 Oxygen Syste

moperate s fromA

C power , DC power , o r

rechargeabl e batteries . Thi s devic e deliver s supplementa l oxygen fo

r patient s throughth e molecula r siev e bed s an di s designe dt o conserv e th e us e o f oxygen whil e operating i

n puls e flo w mode . During puls e flow mode , oxyge n i s delivere dt o the patien t throughapuls e flo

w valv e whe n th e star t i f inhalatio n i s detected .

Page 5-2

### The OMN I 2 Oxyge n Syste mconsist s of

pneumati c an

delectrica l components , A

C power supplies , D C cable s an

dlithiumion batteries . The systemha s inlet filtration , ai

r compressors , an

dSyntheti c Zeolite molecula r siev e bed s wit

harotar y valves , outlet filtration, electroni c flo

w contro l an

daudibl e /

visua l alarms . Intende dUse : The OMN I 2 Oxyge n Syste mi s intendedfo

r th e administratio n of

supplementa

l oxygen . The devic e i s no t

intende dfo

r lif e suppor t nor doe s i t provid e any patient

monitorin g capabilities . Th e OMN

I 2 Oxyge n Syste mi s prescriptio n legendrequired . Technologica l Characteristics ; The OMN I 2 Eclips e Oxygen Syste

moperate s comparably to th e liste dpredicate device . Tlie PS A technolog y employedt o generate the oxygen i s wel l established , an

dtherefore , rais e no new question s o f

safet y an deffectiveness . Performanc e Data : The OMN I 2 Oxygen Syste

mha s acomprehensiv e tes t platfor mtha t cover s syste

m performance , environmenta l conditions , electromagneti c compatibilit y (EMC) , an

d softwar e validation . Th e tes t

platfor mconfirm s complianc e wit hIS O 835 9 standar

dfo r Oxyge n Concentrator

devices . Outside agencie s provide independent analysi s relate dt

o complianc e wit

hEM C an dlE C 60601- 1 (Medica

l Electrica l Equipment—Par

t 1 : Genera

l Requirements) . The tes t platfor mensure s complianc e to recognize dconsensu s standard s an dtherefor e raise s no ne w question s o f safet y an deffectiveness . Conclusion ; Base do n intende duse , technolog y characteristics , desig n an dperformanc e dat

athe OMN I 2 Oxygen Syste

mi s substantially equivalent t o th e currently marketeddevices .

Pag e 5- 3DEPARTMEN T O FHEALT H & HUMA N SERVICE S Publi cHealt h Servic e Foo d an d Dru g Administratio n 1090 3 Ne wHampshir e Avenu e Documen t Contro l Roo m W-O66-060 9 Silve rSpring , M D 20993-000 2 

### Mr . Bria n Jarrel l Directo r o f Qualit y an dRegulator

y Affairs Sequa l Technologies , Incorporate d 1143 6 Sorrento Valley Road Sa n Diego , Californi a92121-130 6 

## OC T2 0 200 9

Re : K08316 3 

### Trade/Devic e Name : OMN I 2 Oxyge n Syste m Regulatio n Number : 2 1 CF R868.544 0 Regulatio n Name : Portabl e Oxyge n Generator Regulator y Class : I I Produc t Code : CA

W Dated : Jun e 11,200 9 Received : September

18 , 200 9 Dea r Mr . Jarrell : W e hav e reviewe dyou

r Sectio n 510(k

) premarket

notificatio n o

f intent t o marke t the devic e referencedabov e andhav e determine dtlie devic e i s substantiall y equivalent (fo r the indication s fo

r us e state din the enclosure ) t o legally markete dpredicate device s marketedi n interstate commerc e prior

to Ma y 28 , 1976 , the enactment

dat e o f th e Medica

l Devic e Amendments , o r

to device s tha

t hav e been reclassifie di

n accordanc e wit

hthe provision s o

f the Federa l Food , Drug , an

dCosmeti c Act

(Act) tha t do not requir e approva l o f apremarket approva l applicatio n (PMA) . Yo

u may , therefore , market

the device , subject

t o the genera

l control s provision s of

the Act , Th e genera

l control s provision s o

f th e Act include requirement s fo

r armua l registration , listin g o

f devices , goodmanufacturin g practice , labeling , an

dprohibition s agains t

misbrandin g an

dadulteration . I f you r devic e i s classifie d(see above ) into eithe r clas s I I (Specia l Controls ) o

r clas s 11 1 (PMA) , i t ma y b e subjec t

t o additiona

l controls . Existin g majo

r regulation s affecting you

r devic e ca n b e foundi

n the Code of

Federa l Regulations , Titl e 21 , Part s 80 0 t o 898 . I n addition , FDA ma

y publis hfurthe

r amiouncement s concernin g you r devic e i n the Federa

l Register .

### Pag e 2 - Mr . Jarrel l

Pleas e b e advise dtha

t FDA' s issuanc e o

f asubstantial equivalenc e determinatio n doe s not mea n tha t FD A ha s mad

e adeterminatio n tha

t you r devic e complie s wit

hothe r requirement s o f the Act or an y Federa l statute s an

dregulation s administere db y other Federa l agencies . Yo u mus t comply wit

hal l the Act' s requirements , including , bu t not limitedto : registratio n an dlistin g (2 1 CF

RPar t 807) ; labelin g (2 1 CF

RPar t 801) ; medica

l devic e reportin g (reportin g o

f medica l device-relate dadvers e events ) (2 1 CF R803) ; goo dmanufacturing practic e requirement s as set fort hi n the qualit

y system s (QS ) regulatio n (2 1 CF RPar t 820) ; an di f applicable , the electroni c produc t radiatio n contro l provision s (Section s 53 1 -54 2 o f the Act) ; 2 1 CF

R1000-1050 . I f yo u desire 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 g o t

o http://www.fda.gov/AboutFDA/CentersOfficcs/CDRHyCDRHOFfices/ucmll5809.hc mfo r th e Cente r fo r Device s an

dRadiological Health' s (CDRH's ) Office o f Compliance . Also , pleas e note th e regulatio n entitled , "Misbrandin g by referenc e t o premarket notification " (21CF RPar t 807.97) . For

question s regardin g the reportin g o f advers e event s unde

r the MDRregulatio n (2 1 CF

RPar t 803) , pleas e g o to http://www.fda.gov/cdrh/mdr / fo r the CDRH' s Office o

f Surveillanc e an

dBiometrics/Divisio n o

f Postmarket

Surveillance . Yo u ma y obtai n oUie

r genera l informatio n on you

r responsibilitie s under

the Act fro mthe Divisio n o

f Small Manufacturers , Internationa l an dConsumer

Assistanc e a

t its toll-free numbe r (800 ) 638-204 1 or

(240 ) 276-315 0 o

r a t its Internet

addres s http://www.fda.gov/cdrh/industry/support/index.html . Sincerely yours . 

## •fo r Susa n Runner , D.D.S, , M.A . Actin g Divisio n Directo r Divisio n of

Anesthesiology , Genera

l Hospita l Infection Contro l andDenta l Device s Office o f Devic e Evaluatio n Cente r fo r Device s an

d Radiologica

l Healt h

Enclosure

### SeQua l Technologie s Inc . 1143 6 Sorrent o Valle yRoad . Sa n Dieg o C A9212 1 US

A 

## Indication s fo rUs e Statemen t Ver / 3 - 4/24/9 6 Applicant : SeQua l Technologie s Inc . 510(k ) Numbe r(i f known) : K© 'S' 3 / ^ 3 Devic e Name : OMN I 2 Oxyge n Syste m indication s Fo rUse : Th e OMN I 2 Oxyge n Syste m i s intende d fo rth e administratio n o f supplementa l oxygen . Th e devic e i s no t intende d fo rlif e suppor t no r doe s i t provid e an ypatien t monitorin g capabilities . Prescriptio n Us e X (Par t 2 1 CF R 80 1 Subpar

t D ) AND/O R Over-The-Counte rUs e _ (2 1 CF R 80 7 Subpar

t C ) (PLEAS E D O NOTWRIT E BELOW THI S LIN E - CONTINU E O N ANOTHE R PAG E I F NEEDED ) Concurrenc e o f CDRH , Offic e o f Devic e Evaluatio n (ODE )

(Pe r2 1 CF R 801.109 ) (Optiona^omTat^^6|i ^ r IntStOk/indus e 

# .pAM ^

(Divisio n Sign-Off

) Division o f Anesthesiology, Genera

l Hospital infectio n Contioi , Denta

l Device s 510(k ) Number: , 

# ^o^^f^ J Pag e 4 - 2 

# X .Exhibi t C 

## ISEQSJAL ' Th e Smar t Choice . SeQua l Technologie s inc . 1 i4:ir t Sorrontf i Vni'- yiv.i.; o Sa n Dle;;o . C- \-i^'i.' ' Phoni ; 85c).;-'02.:ili:i : '^•i^ x 8;:,'H,h;-i8.nr: i vV-,VW.peQu;: i tX'- V 

### Jul y 22 , 201 0

Offic e o f Hazardou s Material s Standard s Pipelin e an dHazardou s Material s Safety Administratio n U.S . Departmen t

o f Transportatio n 120 0 Ne w Jerse y Avenue , S E Washington , D.C . 2059 0 Re : Classificatio n o f

SeQua l Technologies ' Lithiu mio n Battery an dSAROS'^' ^ Oxyge n Svste m T o Who mI

t May Concern : I a mwritin g t o reques t

writte n confirmatio n fromth e Pipelin e an dHazardou s Material s Safet y Administratio n (PHMSA ) that th e lithiu mio n batter y use di n ou r ne w SAROS^^^ Oxyge n Syste mi s no t subjec t t o th e U.S . hazardou s material s regulation s (HMR ) pursuan t t o Special Provisio n 18 8 and may b e carrie donboar dpassenge r aircraf t pursuan t t o 4 9 CFR§ 175.10(a)(17) . Backgroun d Th e SeQual SARO S Oxyge n Syste mi s adevic e that separate s oxyge n fromambien t ai r throug ha proces s calle dPressur e Swin g Adsorpdo n (PSA) . Th e produc t was develope din cooperatio n wit hth e U S Arm y Medica l Materie l Comman dt o support th e oxyge n need s o f

th e patient s o n th e battlefield . Th e SARO S provide s asolutio n t o addres s bothstationary an dportabl e requirement s fo r oxyge n patient s needin g u p t o 3 LPM fial l flow operado n an du p t o 9 6 m l flow in apuls e mod e operation . I t consist s o f

alightweight , portabl e oxyge n concentrato r witha n integrate doxyge n delivery valv e fo r condnuou s flow o r

puls e delivery an di s capabl e o f bein g operate ddirectl y froma n A C o r D C powe r sourc e o r fromrechargeabl e lithiu mio n batteries . I t ca n b e recharge dand/o r

powere db y aseparat e A C Powe r

Adapte r o r wher e standar dA C lin e powe r i s available . A 2 4 Volt

D C Cabl e o r

th e 1 2 Volt D C cabl e accessorie s allo w powe r t o b e provide db y aD C auxiliary powe r ouflet , suc ha s i

n amoto r vehicl e durin g transportation . Changeabl e an drechargeabl e batter y pack s ar e availabl e t o provid e a rang e o f ambulator y operationa l time . Th e SARO S Oxyge n Syste machieve s it s performanc e throug hSeQual' s patente dAdvance d Technolog y Fractionato r (ATF® ) technolog y an dpatente dvariabl e spee dcompresso r an dcompresso r drive , advance dmolecular siev e material s an drechargeabl e batteries . Thi s syste mwil l expan da n oxyge n patient' s ability t o trave l vi aaircraf t an dimprov e th e patient' s qualit y o f life .

# ISEQUAL ' Th e Smart Choice . 

### Clas s 2 , Division 2. 2 Ga s - 4 9 CFR173.11 5 Th e maximu mpressur e o f th e oxyge n exerte dwithi n th e SARO S Oxyge n Syste mpackagin g currentl y i s 23. 7 psi adurin g norma l operatio n a t 20 ° C . Thi s i s substandall y les s than th e 40. 6 psi aa t 20 ° C reference di n 4 9 CFR173.115(b)(1 ) for definin g aDivision 2. 2 gas . Therefore , i t i s ou r opinio n tha

t th e oxyge n exerte dwithi n th e SARO S Oxyge n Syste mi s no t aDivisio n 2. 2 ga s an dthu s i s no t subjec t t o th e U.S . HMR . Lithiu mio n Batterie s use di n SARO S Oxyge n Syste m Th e SARO S Oxyge n Syste mi s powere db y alithiu mio n batter y pac k that consist s o f

16 , 1. 5 ampere hou r lithiu mio n cells . Therefore , th e batter y contain s a n aggregat e equivalen t

lithiu mconten t

o f 7.2 0 gram s (o r 8 6 Watt-hours) . Th e cell s an dbatter y hav e bee n teste dpursuan t t o th e requirement s o f

th e UN Manua l o f

Test s an dCriteria . I t i s ou r opinio n that

th e lithiu mio n batter y i s no t subjec t t o th e HM Rpursuan t

t o Special Provisio n 18 8 becaus e th e cell s contai n no t mor e than 1. 5 gram s o f equivalen t

lithiu mcontent , th e battery contain s no t

mor e than 8 gram s o f

equivalen t

lithiu mcontent , th e cell s an dbatter y hav e bee n teste di n accordanc e withth e UN Manua l o f Test s an dCriteri aan dth e batter y an dSARO S Oxyge n Syste mwil l b e packe dpursuan t

t o th e requirement s o f

Special Provisio n 18 8 whe n offere dfo r transport . Th e battery als o meet s th e excepdo n foun din 4 9 CFR175.10(a ) (17 ) fo r passenger s andcre w members . Thi s provisio n i s generall y consisten t withon e foundin th e ICA O Technica l Instruction s that authorize s consume r

electroni c device s containin g lithiu mio n batterie s withu p t o 100 Watt-hour s t o b e carrie donboardpassenge r aircraft . I trus t th e informatio n containe dherei n i s sufficien t for PHMS A t o provid e awritte n determinatio n that th e SAROS''"' ^ Oxyge n Syste man dlithiu mio n batter y use dt o powe r i t ar e no t subjec t t o th e U.S . HM Rpursuan t

t o Special Provisio n 18 8 an dthe y mee t th e excepdo n foun din 4 9 CFR175.10(a)(17 ) fo r passenger s an dcre w members . Shoul dyo u nee dadditiona l informatio n o r hav e any question s regardin g ou r

product , pleas e d o no t

hesitat e to cal l m e a

t th e contac t

infonnatio n below . Respectfully , \•'/^.|lhL(^LQvJ|i. t 

### Pamel aJ . Jackso n Senio r Director , Governmen t

andMilitary SeQual Technologie s Inc . 1143 6 Sorrent o Valle y Roa d Sa n Diego , C A 9212 1 Phone:858-202-314 4 Cell : 760-805-900 0 Email : piackson(a),sequal.co m Pag e 2 o f 2

# ®

Nemko Nemk o USA , Inc . 1169 6 Sorrento Valley Rd. , Suit e F Sa n Diego , CA 92121-102 4 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0



### TES T REPOR T PE R 

## RCTAINC.DO-160 F FO RTH E 

## Oxyge n Concentrato r Model : 300 0

PREPARE D FOR SEQUA LTECHNOLOGIES , INC . 1143 6 SORRENT O VALLE Y RD . SANDIEGO , CA 9212 1

PREPARE D 

### o

n Apri l 15,201 0 REPOR T NUMBER : 

### 201 0 0414753 4 DO16 0

REVISIO N NON E PROJEC T NUMBER : 

### 42884- 1 NE x Number : 14753 4Nemk o S D USA , Inc .

REVISIO N

- DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phone(858 ) 755-552 5 Fax(858)452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT # 201 0 0414753 4 DOI6 0 PAG E 2 o f 3 2 

## DOCUMEN T HISTOR Y REVISIO N

.

_ DAT E

April 15,201 0 Apri l 15.201 0 COMMENT S

Prepare dBy : Release dBy : Rode l Resolm e Ala n Laudan i NOTE : Nemko USA , Inc . hereb y make s th e followin g statement s s o a s to confomi to th e Requirement s o f E N 17025 "Genera l Criteri aFor

th e Operatio n O f

Tes t Laboratories" : o Th e uni t

describe di

n thi s repor

t wa s receive da

t Nemko USA , Inc.' s facilitie s onApri l 05 , 2010 . o Testin g wa s performe don th e uni t describe di

n thi s repor

t onApri l 05 , 2010. . o Th e Tes t

Result s reporte dherei n apply onl y to th e Unit actuall y tested , andt

o substantiall y identical Units . Thi s Repor

t i s th e propert

y o f Nemko USA , Inc. , andshall not b e reproduced , excep t

i n full , withou t

prior written approval of

Nemko USA , Inc . However , all ownership right s are hereb y returne dunconditionall y t o Sequa l Technologies , Inc. , andapprova l i s hereb y grante dt

o Sequa l Technologies , Inc . an

dits employee s an

dagent s t

o reproduc e all o

r par t o f thi s repor t fo r an y legitimate busines s purpos e withou t furthe r referenc e t

o Nemk o USA , In cNemk o S D USA , Inc .

REVISIO N

- DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT # 201 0 0414753 4 DO16 0 PAGE 3 of 3 2 

## CERTIFICATIO N Th e compatibilit

y testin g andthi s repor

t hav e bee n prepare dby Nemko USA , Inc. , a n independent

electromagneti c compatibilit

y consultin g andtes t

laboratory . Th e compatibilit

y testin g an

dthi s repor

t hav e been prepare db y Nemk o USA , Inc. , a

n independent

electromagneti c compatibilit

y consultin g an

dtes t laboratory . Testin g wa s performe dPe r tes t method s describe di

n RTCA , Inc . DO I60F . 1 certif y th e dat aevaluatio n an

dequipment

configuratio n herein t

o b e atru e an

daccurate representatio n of the sample' s immunit y an demissio n characteristics , a s of the tes t date(s) , an

dfo r the desig n of

th e tes t sampl e utilize dt

o compil e thi s report . 

# 4&-'^y^^^ " Ala n Laudani , EMC/R

FTes t Engineer

### Nemko S D USA , Inc .

REVISIO N



### - DATE

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DOI6 0 PAG E 4 o f 3 2 

## TABL EO FCONTENT S DOCUMENT HISTORY 2 CERTIFICATIO N 3 1 ADMINISTRATIV EDAT A AND TES T SUMMAR Y 6 1. 1 Administrativ e Data6 1. 2 Tes t Specification s 6 1. 3 Tes t

Summar y 7 1.3. 1 Emission s Tes t

Summar y 7 1.3. 2 Other

Test s Summar

y 7 2 SYSTE

M CONFIGURATIO N 7 2. 1 SystemComponent s an dPower Cable s 7 2. 2 Devic e Interconnectio n andI/ O Cable s 7 2. 3 Descriptio n andMetho dof Exercisin g th e UUT 8 2. 4 Figure an dPicture o f actua l tes t Set-up 8 3 TES T SIT EINFORMATIO N 1 0 3. 1 Groun dPlan e 1 0 3. 2 Anechoi c Chamber 1 0 3. 3 Detectio n System1 0 3. 4 Tes t

Equipment

1 1 4 DO-160 FTest s 1 2 4. 1 Bondin g Tes t

1 2 4.1. 1 Bondin g Tes t

Metho d1 2 4.1. 2 Bondin g DataSheet s 1 2 4.1. 3 Tes t

Equipment

Lis t 1 2 4. 2 Emissio n of

Radi o Frequenc y Energ y Tes t 1 3 4.2. 1 Sectio n 2 1 Emissio n of Radi o Frequenc y Energy Tes t Metho d1 3 4.2. 2 Radiate dEmission s Tes t Data1 5 4.2. 3 Radiate dEmission s Photograph s 1 9 4.2. 4 Tes t

Equipment

Lis t 2 8 APPENDICE S APPENDIX A : Logsheet

A l APPENDIX B . Nemko USA , Inc . Tes t Equipment

& Facilitie s Calibratio n Progra mB l APPENDIX C : NVLA PAccreditatio n C I

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phone(858)755-552 5 Fax(858)452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT # 201 0 0414753 4 DOI6 0 PAGE 5 of 3 2 

### LIS T O FFIGURE S FIGUR E2.4- 1 UU T TES T SETU P FIGUR E2.4- 2 GENERA LTES T SET-U P FIGUR E2.4- 2 SARO S OXYGE NSYSTE M TES T CONFIGURATIO N FIGUR E4.2- 1 RADIATE D EMISSION S ANTENN A CONFIGURATION S FIGUR E4.2- 2 AMBIEN T SCA N HORIZONTA L FIGUR E4.2- 3 AMBIEN T SCA N VERTICA L FIGUR E4.2- 4 HORIZONTA L120VA C 60H z DAT A HORIZONTA L FIGUR E4.2- 5 HORIZONTA L120VA C 60H z DAT A VERTICA L FIGUR E4.2- 6 HORIZONTA LBATTER Y ONL Y DAT A HORIZONTA L FIGUR E4.2- 7 HORIZONTA LBATTER Y ONL Y DAT A VERTICA L FIGUR E4.2- 8 HORIZONTA L24VD C DAT A HORIZONTA L FIGUR E4.2- 9 HORIZONTA L24VD C DAT A VERTICA L FIGUR E4.2-1 0 10 0 MH z T O 20 0 MH z RANG E120VA C 60H z FIGUR E4.2-1 1 20 0 T O 1 GH Z RANG E120VA C 60H z FIGUR E4.2-1 2 1 T O 6 GH Z RANG E120VA C 60H z FIGUR E4.2-1 3 10 0 MH z T O 20 0 MH z RANG EBATTER Y ONL Y FIGUR E4.2-1 4 20 0 T O 1 GH z RANG EBATTER Y ONL Y FIGUR E4.2-1 5 1 T O 6 GH z RANG EBATTER Y ONL Y FIGUR E4.2-1 6 10 0 MH z T O 20 0 MH z RANG E24VD C FIGUR E4.2-1 7 20 0 T O 1 GH z RANG E24VD C FIGUR E4.2-1 8 1 T O 6 GH z RANG E24VD C 9 9 1 4 1 5 1 5 1 6 1 6 1 7 1 7 1 8 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 

### LIS T O FTABLE S Tabl e 1 Emissio n Test s 6 Tabl e 2 Othe r

test s 6 Tabl e 3 Emission s Tes t Summar y 7 Tabl e 4 Othe r

Tes t Summar y 7 Tabl e 5 Bondin g Tes t Result s 1 2 Tabl e 6 Bondin g Equipmen t Lis t 1 2 Tabl e 7 Equipmen t

Lis t 2 8Nemk o S D USA , Inc .

REVISIO N

- DATE

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DO16 0 PAG E 6 o f 3 2 

## 1 ADMINISTRATIV EDATA AN D TES T SUMMARY L I Administrativ e Dat a CLIENT :

CONTACT : E-MAIL : Sequa l Technologies , Inc . 1143 6 Sorrento Valley Rd . Sa n Diego , C

A 9212 1 (858)202-316 4 LoA n Maye r imayer(gsequal.co m DAT E(S ) O FTEST : Apri l 05,201 0 UNIT UNDE

RTES T (UUT) : PART NUMBER : SERIALNUMBER : CONDITIO N UPO N RECEIPT Oxygen Concentrato r 300 0 3 Suitabl e fo

r Tes t 

### 1.2 Tes t

Specification s Radi o Frequenc y Emission s andElectromagneti c Immunit y test s i n accordanc e wit

hthe requirement s of

RCTA , Inc . DO-160F . Tabl e 1 Emissio n Test s Tes t Metho d Sectio n 2 1 Requiremen t

RCTA , Inc . DO-160 F Descriptio n Emissio n of

R FEnerg y Radiate d Frequenc y Rang e

10 0 MH z to 6 GH z Limi t Categor y M Tabl e 2 Othe rtest s Tes t Metlio d Bondin g Tes t Requiremen t

<2.5mf i Descriptio n

Measurement

o f groun d plan e resistanc e Frequenc y Rang e N/ A Limi t

2.5m QNemk o S D USA , Inc .

REVISIO N

- DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , Sa n Diego , C

A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DO16 0 PAGE 7 o f 3 2 

### L 3 Tes t Summar y Sectio n 21 , Emissio n of

R FEnerg y Test , radiate demission s on 3 differen t modes : 120VAC 60Hz , battery , and24VDC . L3. 1 Emission s Tes t

Summar y Tabl e 3 Emission s Tes t Summar y 

### Specificatio n RCTA , Inc . DO-I60F , Sectio n 2 1 radiate d 

### Frequenc y Rang e Cat . M 100MHzto6GH z 

### Complianc e Statu s Passe d 

### L3. 2 Othe r

Test s Summar y Tabl e 4 Othe rTes t Summar y 

### Specificatio n Tes t Requirement s Complianc e Statu s Bondin g Tes t < 2. 5 mOh m Passe d Refe r t o th e tes t

result s sectio n fo r

furthe r details . 

## 2 SYSTEM CONFIGURATIO N 2. 1 Syste mComponent s an dPowe r Cable s DEVIC E EU T - Oxygen Concentrato r EU T - Power

Supply Unit MANUFACTURER MODEL# SERIAL * Sequa l Technologies , Inc . Model : 300 0 Seria l # : 3 S LPowe r Electronic s Corp . Model : MENTI220A2400F0 4 Seria l # : Sampl e 1 2 POWE RCABL E Powere db

y externa

l A C power suppl y 2m , 1 8 AWG , 3 wire . Medica l lE C connector s 

### 2. 2 Devic e Interconnectio n an dI/ O Cable s Connectio n N/A I/ O Cabl e 1 

# 1 N/ A

### Nemko S D USA , Inc .

REVISIO N



### - DATE

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , Sa n Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DO16 0 PAGE 8 o f 3 2 

### 2. 3 Descriptio n an dMetlio do f Exercisin g th e UUT . Th e Mode l 300 0 i s anOxyge n Concentrator . It s functio n i s t o extrac t oxyge n fro m th e atmosphere , concentrat e i t t o greate rtha n 9 0 % an d flo wi t throug h th e oxyge n outpu t port . Th e EU Twa s exercise d i n th e followin g thre e (3 ) operationa l configurations : A C operatio n an d charging , D C operatio n an d chargin g an d Batter

ypac k (externa l attached ) operation . Th e EU Tmod e o f operatio n i n al l case s was Continuou s flo w a t 3 LPM i n Tactica l Mode . I f testin g induce s a mod e chang e o rth e EU Tstop s operatio n o rcharging ; thi s ma yb e considere d a failure . Th e EUT' s performanc e durin g tes t wa s evaluate dagains t

th e performanc e criterio n specifie dby applicabl e tes t standards . Performanc e result s ar e detaile di

n th e tes t result s sectio n of

thi s report . 

### 2. 4 Figur e an dPictur e of actua l tes t

Set-u p 

## Figur e 2.4- 1 UU T Tes t

Setu p

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT S 201 0 0414753 4 D O 16

0 PAG E

9 of 3 2 

## Figur e 2.4- 2 Genera l Tes t Set-U p

•'.•:\(.t:-iv^<L'C' . •'<. ; C .l i I 

### t_« i NLli.^^.•••^;u;!l•. e M.inoc M 

### rVf^Yl . y 

## .A^ . 7 p ' - 

# -iZ ^

'••^y . 

### / / / 

## Figur e 2.4- 2 SARO S Oxyge n Syste mTes t Configuratio n

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DOI6 0 PAG E 10of3 2 

## 3 TES T SIT EINFORMATIO N Th e tes t site i s locate dat : NEMK O USA , Inc . 1169 6 Sorrent o Valley Road , Suite F Sa n Diego , CA 9212 1 NEMKO US A i s NVLA Pcertified . Th e NVLA PCertificatio n i s include din Appendi x C of thi s document . The site i s physicall y locate d1 8 mile s northwes t o f downtow n Sa

n Diego . Th e general are ai s avalle y 1.5 mile s eas t o f th e Pacifi c Ocean . Th e EMI testin g wa s under th e guidanc e of

Nationa l Associatio n of

Radi o an dTelecommunicatio n Engineer s (NARTE ) personnel . 

## 3. 1 Groun dPlan e Th e emission s andsusceptibility portion s o f th e testin g wa s performe don agroun dplane . Th e groun dplan e consiste d o f a8 ' X 3 ' X 1/8 " thic k

copper plate mounte do n awooden benc han di s connecte dto th e groun dro dvi aacopper bu s ba r 2 ' wid e an d0.25 " thick . Th e D C bondin g resistanc e betwee n th e groun dplan e an dgroun dwa s les s tha n 2.5mQ . Th e Uni t Under Tes t (UUT ) andLin e Isolatio n Stabilizatio n Networ k (LISN ) were bonde dto th e groun dplane . 

## 3. 2 Anechoic Chamber Th e radiate dan dconducte demission s test s were conducte dinside asem i anechoi c chamber

whic hmeasure s 20 ' x 12 ' x 10' . Carbon-loade dcone s provid e R Fdissipation . Radiate dsusceptibilit y test s were conducte dinside asem i anechoi c chamber whic hmeasure s 20 ' x 12 ' x 10' . Power capabilit y of th e chamber

include s 5 0 amp s a

t lOOVDC , 3 0 amp s pe

r phas e o f 12 0 VA C a t 40 0 Hz , an d5 0 amp s o f

u p to 25 0 VA C a

t up to 6 0 Hz . 

## 3. 3 Detection Syste

m Th e automate ddetectio n systemuse din emissio n testin g consist s o f aspectru manalyzer

controlle dby acomputer . Preamplifier s use dwher e necessary an dwhere the y are use da n appropriate notatio n i s mad e i n th e relevant

sectio n of th e report . Commerciall y availabl e EMI measurement softwar e Tota l Integrate dLaborator

y Environment

(TILE ) wa s use din th e performanc e o f thes e measurements . I

n thi s softwar

e package , th e bandwidth s andmeasurement time s ar e user-selectable , andth e bandwidth s andsweep time s were per th e requirement s RTCA , Inc . DO-160F .

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Aprin5,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT * 201 0 0414753 4 DO l 6 0 PAG E 1 1 of3 2 

### 3. 4 Tes t

Equipmen t NEMKO USA , Inc . operate s acomprehensiv e Periodi c Calibratio n Progra mi n order to ensure th e validit

y of all tes t data . NEMK O USA' s Periodi c Calibratio n Progra mi s full y compliant

t o th e requirement s of

NVLAPIS O Standar

d 17025 . NEMKO USA , Inc.' s calibratio n programtherefore meet s o r exceed s th e U S national commercia l an dmilitar y requirement s [N.B . ANSI/NCS LZ540-1 . Specifically , all of NEMKO XMA' s primar y referenc e standar ddevice s (e.g . vecto r voltmeters , multimeters , attenuator s andterminations , R Fpower meter s an

dtheir detecto r heads , oscilloscop e mainframe s an dplug-ins , spectru manalyzers , R Fpreselectors , quasi-pea

k adapters , interferenc e analyzers , impuls e generators , signal generator s an dpulse/fianction generators , field-strengthmeter s andtheir detecto r heads , etc. ) and certai n secondary standar ddevice s ar e periodicall y recalibrate dby :

• A NEMKO USA-approve dindependent (thirdparty ) metrolog y laborator y tha t use s NIST-traceabl e standard s an d tha t i s IS O Standard17025-accredite da s acalibratio n laboratorie s b y NIST ; or , • A NEMKO USA-approve dindependen t (thirdparty ) metrolog y laborator y tha t use s NIST-traceabl e standard s an d tha t i s IS O Standard17025-accredite da s acalibratio n laborator y b y another

accreditatio n body (suc has A2LA ) tha t i s mutuall y recognize db y NIST ; or , • A manufacturer

of Measurement

an dTes t Equipment

(M&TE) , if

th e manufacturer

use s NIST-traceabl e standard s an di s IS O Standard17025-accredite da s calibratio n laborator y either b y NIS T or

b y another

accreditatio n bod

y (suc ha s A2LA ) tha

t i s mutuall y recognize db y NIST ; or • A manufacturer

o f M&TE(or

b y aNEMKO USA-approve dindependent thirdpart y metrolog y laboratory ) tha t i s no t IS O Standard17025-accredited . (In thes e cases , NEMKO US A conduct s a n annual audi t

o f th e manufacturer or metrolog y laborator

y fo r th e purpose s of

provin g traceability t o NIST , ensurin g tha t adequate an

drepeatabl e calibratio n procedure s ar

e bein g applied , andverifyin g conformit y wit hth e other

requirement s of

IS O Standard 17025) . I n ail cases , th e entit

y performin g th e Calibratio n i s require dto furnis hNEMKO US A wit hacalibratio n tes t

repor t and/o r certificate o f

calibration , anda"calibratio n sticker " on eac hitemo f M&T Etha t i s successfully calibrated . Calibratio n interval s are normall y on e year , excep t whe n th e manufacture advise s ashorter interva l o r i f US Government

directive s or

client requirement s deman dashorter interval , Item s of

instrumentation/relate dequipment whichfai l durin g routin e use , or

whic hsuffe

r visibl e mechanical damag e (durin g us e o r whil e i n transit) , are sideline d pendin g repair

andrecalibration . (Repair s ar e carrie dou

t either in-hous e [if

minor ] o r by aNEMKO USA-approve d independent

[thir dparty ] metrolog y laboratory , or b y th e manufacturer

o f th e ite mo f M&TE) , Eachantenn ause dfo

r radiate demission s testin g i s calibrate dannuall y b y either aNIS T (or

A2LA ) IS O Standar

d 17025-Accredite dthird-part y Antenn aCalibratio n Laborator y o r b y th e antenna' s OE

M if th e OE M i s NIS T o

r A2L A IS O Standard17025-accredite da s a n antenn acalibratio n laboratory . Note : Th e reaso n NC R(n o ca l required ) equipment

i s use di n ates t se t u p an dstil l support s th e tes t i s tha t other calibrate dequipment

i s usedi n acalibratio n tes t

set u p before runnin g the officia l test .Nemk o S D USA , Inc .

REVISIO N

- DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMEN T # 201 0 0414753 4 DO16 0 PAG E 1 2 o f 3 2 

## 4 DO-160 FTest s 4. 1 Bondin g Tes t 4.1. 1 Bondin g Tes t

Metho d Per DO160F , th e bondin g betwee n th e LISN' s andgroun dplan e were measure dandverifie dto b e les s tha n 2, 5 milli ohms . 

### 4.1. 2 Bondin g Dat aSheet s Custome r Jo b orde r Tes t Enginee r Dat e Standar d Remark s Sequa l Technologies , Inc . 42884- 1 Rode l Resolm e Apri l 5 , 201 0 RTCADO160 F 300 0 Tabl e 5 Bondin g Tes t Result s Fro m Locatio n Wal l Tabl e Tabl e T o

Locatio n Tabl e LIS N Positiv e LIS N Negativ e Measure d m O 1. 8 0.0 9 0.0 8 Limi t

mf l 2. 5 i 1 Pas s

Pas s Pas s Pas s Remarl< s



### 4.1. 3 Tes t

Equipmen t

Lis t Tabl e 6 Bondin g Equipmen t Lis t Asse t No . 82 4 90 4 Descriptio n

USN , Se t Micro-ohmmete r Par t Numbe r Numbe r Corn-Powe r

LI-40 0 Keithle y 58 0 Seria l Numbe r 2506 3 40233 6 Las t Cal . 4-14-0 9 7-13-0 9 Ca l du e

4-14-1 0 7-13-1 0

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMEN T # 201 0 0414753 4 DO16 0 PAG E 1 3 of 3 2 

### 4. 2 Emissio n of

Radi o Frequenc y Energ y Tes t 4.2. 1 Sectio n 2 1 Emissio n of Radi o Frequenc y Energ y Tes t Metho d Thes e test s determin e tha

t th e equipment

doe s no t emit undesire dR

Fnois e i n exces s of

th e level s specifie dbelow . The notche s specifie di

n th e radiate demission s limit s are include dto protec t aircraf t R Fsensor s operatin g a

t thos e frequencies . Radiate dEmission s shal l meet th e Categor

y M limit s a s specifie di n DO-160 FSectio n 21, 4 andFigure 21-5 , The radiate demissio n wil l b e measure dfro m10 0 MH z to 6 GHz ,

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT # 201 0 0414753 4 DO16 0 PAG E 1 4 of 3 2 

## Figur e 4.2- 1 Radiate dEmission s Antenn aConfiguration s

Tes t Setu p Boundar y

Groun d Plan e Bondin g Stra p 

## RO D Counterpois e Floo r

Tes t Setu p Boundar y

Groun d Plan e 

## BICONICA L

Tes t Setu p Boundary

Groun d Plan e 

## DOUBL E RIDG E HOR N

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DOI6 0 PAG E 1 5 of 3 2 

## 4.2. 2 Radiate dEmission s Tes t Data Figur e 4.2- 2 AMBIEN T SCA N Horizonta l

Nemk o US A MIL-STD.461 D To. t Metho d RE10 2 Horizonta l Polarizatio n Radiate d Emission s Ambien t Scan s Sequa l Technoiogies , Inc . SARO S Oxyge n System , Mode l 300 0 42884-1/147S3 4

11:S1:35AM , Thursday , Apri l 15,201 0



## Figur e 4.2- 3 AMBIEN T SCA N Vertica l

Nemk o US A MIL-STD-461 F Tes t Metho d RE10 2 Vertica l Polarizatio n Radiate d Emission s Ambien t Sca n Sequa l Technologies , Inc . SARO S Oxyge n System , Mode l 300 0 42684-1/14753 4

• t ! • t t )

11:46:1 1 AM , Thursday , Apri l 15 , 201 0

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DO16 0 PAGE 1 6 o f 3 2 

## Figur e 4.2- 4 Horizonta l 120VA C 60H z Dat aHorizonta l Nemk o US A MIL-STD-461 D Tes t Metho d RE10 2 Horizonta l Polarizatio n Radiate d Emission s 120VA C 60H z Sequa l Technologies , Inc . SARO S Oxyge n System , Mode l 300 0 426S4-1/147S3 4 120VA C COH z

20.0-J 10. 0 -10.0 : r •20. 0 - . 7 *JM«MJ»*IM*<* *

-30.0 '

11:27:1 1 AM , Monday , Apri l 05 , 201 0 LO G Frequenc y 

## Figur e 4.2- 5 Horizonta l 120VA C 60H z Dat aVertica l

Nemk o US A MIL-STD-461 F Tes t Metho d RE10 2 Vertica l Polarizatio n Radiate d Emission s 120H z 60H z

100. 0 • ^ 90.o•i • 80. 0 70. 0 60.0- t 50. 0 5 40.0- t m 30.0:1 - T 3 20.0-J 10. 0 0 •lO.O- t -20.0 : r Sequa l Technoiogies , inc . SARO S Oxyge n System , Mode l 300 0 428B4-1/14753 4 120VA C 60H z 

# wU<-* ^

LO G Frequenc y 11:25:5 6 AM , Monday , Apri l 05 , 201 0

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DO16 0 PAG E 17of3 2 

## Figur e 4.2- 6 Horizonta l Batter y Onl y Dat aHorizonta l Nemk o US A MIL-STD-461 D Tes t Metho d RE10 2 Horizonta l Polarizatio n Radiate d Emission s Batter yPowere d

100. 0 T 90.0 : r •0.0 : r Sequa l Technologies , Inc . SARO S Oxyge n System , Mode l 300 0 42684-1/14753 4 Batter yPowere d

-10. 0 •20.0- f -30.0 ' 

### S^^fNfmf^" ^

LO G Frequenc y 12:36:1 5 PM , Monday , Apri l 05 , 201 0



## Figur e 4.2- 7 Horizonta l Batter y Onl y Dat aVertica l

Nemk o US A MIL-STD-461 F Tes t Metho d RE10 2 Vertica l Polarizatio n Radiate d Emission s Batter yPowere d

100.0- q Sequa l Technologies , Inc . SARO S Oxyge n System , Mode l 300 0 42684-1/14753 4 Batter yPowere d

E 

### t O 30.0 ' 20. 0 10. 0 0 : • •10.0-f - •20. 0 -30. 0 

### JiMiiiiii i a t Al i \k\\ik \ 

## -'^mwNnwr^ni^iii i 

# J^M^JUm ^

LO G Frequenc y 12:32:4 7 PM , Monday , Apri l 05 , 201 0

### Nemko S D USA , Inc .

REVISIO N



### - DATE

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT # 201 0 0414753 4 DOI6 0 PAG E 18or3 2 

## Figur e 4.2- 8 Horizonta l 24VD C Dat aHorizonta l Nemk o US A MIL-STD-461 D Tes t Metho d RE10 2 Horizonta l Polarizatio n Radiate d Emission s 28VD C

100. 0 90.0- ^ 80. 0 70. 0 60. 0 50. 0 J 40.0 m30.0- ^ 20. 0 10.0- t -lO.O-i r -20.0 : r Sequa l Technologies , Inc . SARO S Oxyge n System , Mode l 300 0 42884-1/14753 4 28VD C

-30. 0 

### iWM<%.**-J ^

LO G Frequenc y 02:09:2 1 PM , Monday , Apri l 05 , 201 0



## Figur e 4.2- 9 Horizonta l 24VD C Dat aVertica l

Nemk o US A MIL-STO-461 F Tes t Metho d RE10 2 Vertica l Polarizatio n Radiate d Emission s 26VD C

100.0- 3 so.o 80.0 - 70.0 - 80.0 - 50.0 - 5 40.0 - m 30.0 - 20.0 - 10.0 - 0 - -10.0 - -20.0 - r r r r 

### :

" • - ' ~ 

## rL——' a \M4 I I k I I 

## *''^\*.jji«W» ^ 

# l%¥^ ^ 

# V

-

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02:06:3 7 PM , Monday . Apri l 05 , 201 0 Sequa l Technologies , Inc . SARO S Oxyge n System , Mode l 300 0 42S84-1/147S3 4 28VD C 

# tr ^ 1

- - . I* " * j j 1 1 V ^ 

### Amf/M^*" ^ L^ ^ 

# s

Frequenc y 

### "" "

. . 1. . ji.1 . ^^M^lKHldl^BP^^^^^^ ^

10.D G

### Nemko S D USA , Inc .

REVISIO N



### - DATE

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , Sa n Diego , C

A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO l 60 FTes t

Repor t DOCUMENT S 201 0 0414753 4 DO16 0 PAG E 19of3 2 

### 4.2. 3 Radiate dEmission s Photograph s



## Figur e 4.2-1 0 100 MH z t o 20 0 MH z rang e 120VA C 60H z

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 II696Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DOI60 FTes t

Repor t DOCUMENT * 201 0 0414753 4 DO16 0 PAG E 2 0 o f 3 2 

## Figur e 4.2-1 1 20 0 t o 1 GH z rang e 120VA C 60H z

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , Sa n Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT * 201 0 0414753 4 D O 160 PAG E 2 1 or3 2 

## Figur e 4.2-1 2 1 t o 6 GH z rang e 120VA C 60H z

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMEN T # 201 0 0414753 4 D O 16

0 PAG E

2 2 of 3 2 

## Figur e 4.2-1 3 10 0 MH z t o 20 0 MH z rang e Batter y Onl y

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858)755-552 5 Fax (858)452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMEN T # 201 0 0414753 4 DO16 0 PAG E 2 3 o f 3 2 

## Figur e 4.2-1 4 20 0 t o 1 GH z rang e Batter y Onl y

### Nemko S D USA , Inc .

REVISIO N

- DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT * 201 0 0414753 4 DO16 0 PAG E 2 4 of 3 2 

## Figur e 4.2-1 5 1 t o 6 GH z rang e Batter y Onl y

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Aprin5,201 0 1169 6 Sorrent o Valle y Road , Suit e F , Sa n Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMENT * 201 0 0414753 4 DO16 0 PAG E 2 5 of 3 2 

## Figur e 4.2-1 6 10 0 MH z t o 20 0 MH z rang e 24VD C

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , Sa n Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 r Tes t Repor t DOCUMEN T # 201 0 0414753 4 DO16 0 PAG E 2 6 of 3 2 

## Figur e 4.2-1 7 20 0 t o 1 GH z rang e 24VD C

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMEN T # 201 0 0414753 4 DO16 0 PAG E 27 of 3 2 

## Figur e 4.2-1 8 1 t o 6 GH z rang e 24VD CNemk o S D USA , Inc .

REVISIO N

- DAT E

Apri l 15 , 201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc . Model : 300 0 DO160 FTes t

Repor t DOCUMEN T * 201 0 0414753 4 DO16 0 PAG E 2 8 o f 3 2 

### 4.2. 4 Tes t

Equipmen t

Lis t Tabl e 7 Equipmen t Lis t Asset No . 11 7 31 7 82 5 82 4 35 0 75 2 91 1 90 1 Descriptio n

Antenna , Eico n Pre-amp , H P LIS N Set , Corn-Powe r LIS N Set , Corn-Powe r Antenna , Dua l Ridg e Antenna , DR GHor n Spectru mAnalyzer , Agilen t Pre-amp , Sonom a Par t Numbe r Numbe r BIA-2 5 8449 A Ll-40 0 LI-40 0 RGA3 0 311 5 E4440 A 310 N Seria l Numbe r 261 1 2749 A 2506 4 2506 3 222 5 494 3 US4142126 6 13060 7 Las t

Cal . 5/18/0 9 4/16/0 9 6/18/0 9 4/14/0 9 4/9/0 9 11/12/0 8 12/17/0 9 3/27/0 9 Ca l du e

5/18/1 1 4/16/1 0 6/18/1 0 4/14/1 0 4/9/1 1 11/12/1 0 12/17/1 0 3/27/1 0

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , CA 9212 1 Phone(858)755-552 5 Fax(858)452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc .

300 0 DO160 FTes t

Repor t DOCUMENT * 201 0 0414753 4 DO16 0 PAG E B l of 3 2



### APPENDI X B . Nemk o USA , Inc . Tes t Equipmen t

& Facilitie s Calibratio n Progra m Nemko USA , Inc . operate s acomprehensiv e Periodi c Calibratio n Progra min order

t o ensur e th e validity o f

all tes t data . Nemko USA' s Periodi c Calibratio n Progra mi s full y compliant

to the requirement s o f

NVLAPPolic y Guide PG-1 - 1988 , ANSI/NCS LZ540-1-1994 , IS O 10012 : 2003 , ISO/IE C 17025:1999 , andlSO-9000 : 2000 . Nemk o USA , Inc.' s calibration s programtherefore meet s or exceed s th e US national commercial andmilitar y requirement s [N.B . ANSI/NCS LZ540-1-199 4 replace s M1L-STD-45662A] . Specifically , all o f

Nemko USA' s primar y referenc e standar ddevice s (e.g . vecto r voltmeters , multimeters , attenuator s andterminations , R

Fpower meter s andtheir

detecto r heads , oscilloscop e mainframe s andplug-ins , spectrumanalyzers , R Fpreselectors , quasi-pea

k adapters , interferenc e analyzers , impuls e generators , signa l generator s andpulse/functio n generators , field-strengt

hmeter s an dtheir

detecto r heads , etc. ) an dcertai n secondary standar ddevice s (e.g . R F Preamplifier s use din CISPR11/2 2 an dFC C Par t 15/1 8 tests ) are periodicall y recalibrate dby : o A Nemko USA-approve dindependent (thirdparty ) metrolog y laborator y tha t use s NIST-traceabl e standard s an dtha

t i s IS O Guid e 25-accredite da s acalibratio n laboratorie s b y NIST ; or , o A Nemko USA-approve dindependen t (thirdparty ) metrolog y laborator y tha t use s NIST-traceabl e standard s andtha

t i s IS O Guid e 25-accredite da s acalibratio n laborator y by another

accreditatio n bod

y (suc ha s A2LA ) tha

t i s mutuall y recognize dby NIST ; or , o A manufacturer

of Measurement

andTes t Equipment

(M&TE) , if

th e manufacturer

use s NIST-traceabl e standard s an di s IS O Guid e 25-accredite da s calibratio n laborator y either b y NIS T o

r b y another accreditatio n body (suc ha s A2LA ) tha t i s mutuall y recognize dby NIST ; o r o A manufacturer

of M&T E(or by aNemko USA-approve dindependent thirdpart y metrolog y laboratory ) tha t i s no t IS O Guid e 25-accredited . (I n thes e cases , Nemko US A conduct s a n annua l audi t of th e manufacturer

o r metrolog y laborator

y fo r th e purpose s of

provin g traceability t

o NIST , ensurin g tha

t adequate an drepeatabl e calibratio n procedure s are bein g applied , andverifyin g conformit y wit hth e other requirement s o f

IS O Guid e 25) .

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fax (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc .

300 0 DOI60 FTes t

Repor t DOCUMENT * 201 0 0414753 4 DO16 0 PAG E B2of3 2

I n all cases , th e entit

y performin g the Calibratio n i s require dto furnis hNemko US A wit hacalibratio n tes t

repor t and/or certificate o f

calibration , an da"calibratio n sticker " o n eac hitemo f M&T Etha t i s successfully calibrated . Calibratio n interval s are normall y on e year , excep t when th e manufacture advise s ashorter interva l o r if U S Government

directive s or

client requirement s deman dashorter interval . Item s o f

instrumentation/relate dequipment whic hfail durin g routin e use , o r whic hsuffe

r visibl e mechanical damag e (durin g us e o r whil e in transit) , are sideline d pendin g repair

andrecalibration . (Repair s are carrie dout either in-hous e [if

minor ] or

b y aNemko USA-approve d independent

[thir dparty ] metrolog y laboratory , o r by th e manufacturer

of th e itemo f

M&TE) . Eachantenn ause dfo

r CISPR1 1 andCISPR2 2 andFC C Par t 1 5 an dPar t 1 8 radiate demission s testin g (andfo r testin g to th e equivalent

Europea n Norms ) i s calibrate dannuall y b y either aNIS T (o r

A2LA ) IS O Standard17025-Accredite d third-party Antenn aCalibratio n Laborator y or b y th e antenna' s OE

M if th e OE M i s NIS T or

A2L A IS O Standar

d 17025-accredite da s a

n antenn acalibratio n laboratory . Th e antenn acalibration s ar e performe dusin g th e method s specifie di

n Annex G. 5 o f

CISPR16-1(2003 ) or

ANS I C63.5-2004 , includin g th e "Three-Antenn aMethod" . Certai n other kind s o f antenna s (e.g . magnetic-shielde dloop antennas ) are calibrate dannuall y b y either aNIS T (or

A2LA ) IS O Standard17025-accredite dthird-part y antenn acalibratio n laboratory , o r b y th e antenna' s OE

M if th e OE M i s NIS T o

r A2LA IS O Standard17025-accredite da s a n antenn acalibratio n laborator y usin g th e procedure s specifie di n th e lates t versio n o f SA EARP-958 . I n accordanc e wit

hFC C an

dother regulations , Nemko US A recalibrate s it s suite of antenna s usedfo

r radiate d emission s test s on a

n annua l basis . Thes e calibration s are performe da s aprecurso r t o the FCC-require dannua l revalidatio n o f

th e Normalize dSite Attenuatio n propertie s o f Nemk o USA' s Open Are aTes t Site . Nemk

o USA , Inc . use s th e procedure s give n i n bot hSu b claus e 16. 6 andAnnex G. 2 of CISPR16- 1 (2003) , and , ANS I C63.4-200 3 whe n performin g th e normalize dsite attenuatio n measurements .

### Nemko S D USA , Inc .

REVISIO N



### - DAT E

Apri l 15,201 0 1169 6 Sorrent o Valle y Road , Suit e F , San Diego , C A 9212 1 Phon e (858 ) 755-552 5 Fa x (858 ) 452-181 0 DOCUMEN T NAM E Sequa l Technologies , Inc .

300 0 DO l 60 FTes t

Repor t DOCUMEN T # 201 0 0414753 4 DO16 0 PAG E C I of 3 2 

## APPENDI X C : NVLA PAccreditatio n Unite d State s Departmen t o f Commerc e Nationa l Institut e o f Stanciard s an d Technolog y



# Certificat e o f Accreditatio n t o ISO/IE C 17025:200 5 NVI.API.AHCODE : 200116- 0 

## Ncnik o USA , Inc . - Sa

n Dicgo EM C Division San Diego , C A I S eccroOite d b ySh e Naliona l Volwtlar yLafcoralo/ yAcoredilatio n Progrn m fo rspociti csorvicos , liste d o n th e Scop e o f Accrediialion , tor : 

### ELECTROMAGNETI C COMPATIBILIT Y AN D TELECOMMUNICATION S Thi s laborator yi s accredile d i n accordanc o wit h th e recot/rnzc d IntomalioiKi l Standar d ISO/IE C 17025200 5 Thi s accreditatio n demonstrate s technica l competenc e lo ra define d scop e an d tfi e operatio n o f a laboiatot yQualit y

managemon i syste m (refe rt o join t ISO-lLAC-tA F Communiqu e date d Januar y200S) . /.•*:" " !° V 2I)1I)-01-0 1 lliroiii;l i 20111-12-1 1

Effectiv e date s JfittOfUt I fnaUiitt i o f Stunc'iHil s an d Tect'noit : hfV/LAP-01ClRE\. ' 70C'9-0\-2S )