MEuerFlc)' AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/o UserManual AMSR oxygenconcentratorstore.com 1-877-774-9271 EverFloUserManual SymbolKey m n E Follow Instructions forUse -\/ A(Power Type BFApplied Part REF ModelNumber 0assllequipment SN SerialNumber s Nosmoking @ Nooilorgrease @ Donotdisassemble lPXl proof Drip equipmenr A General Alarm c Action Required, Check System Notification ( C \ \ European Declaration ot 0123 .@;. L0nlormtty [anadian/U5 [ertification I | 0n(Power) Off(Power) r Compliant withtheWaste Electrical andElectronic EquipmenVRestriction oftheUse of(ertain Hazardous Substances inElectrical andElectronic (WEEE/RoH5) Equipment recycling directives Rao\L / (aution! U.5. federal lawrestricts thisdevice to sale byorontheorder ofaphysician. Abbreviations LED Light Emitting Diode LPM perMinute Liters OPI 0xygen Percentage Indicator EverFlo is a trademark of Respironics,Inc. and its affiliates. @ 2007 Respironics,lnc. and its affiliates.All rights reserved AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/o UserManual Chapter1: Introduction Your health careprofessionalhas determined that supplementaloxvgen is ofbenefir to vou and has prescribed an oxygen concentrator set at a specific {1o*.setting to meer vour needs.DO NOT change the llorv settings unlessyour health care professionaltellsvou to do so. Pleaseread and understandrhis entire manual before usins the device. IntendedUse TheEverF/o-- Ox,vgenConcentrator is intended to provide supplemental oxygen ro persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. AboutYourEverF/o The device produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieveand a pressureswi'rg adsorprion process.Your home care provider will show you how to operate the concentrator and will be availableto answer any questions. Ifyou have additional questions or problems, contact your horne care provider. Partsof YourConcentrator H u m i d i f i e rB o t t l e Mounting Strap d . OxygenOutiet /' Port 1". - - Air lnletFilter ri.W;L- Humidifier Connector Tube C o n t r o lP a n e l On/Off Switch Flow Meter Accessory Equipmentand Replacement Parts Contact your home care provider if you havequestionsabout this equipment. Use only the fbllowing Respironicsaccessories and replaccmenrparrswith this device: - Air Inlet Filter - Hurnidifie r Connector'lirbe AMSR oxygenconcentratorstore.com 1-877-774-9271 EverFloUserManual Warningsand Cautions Caution! U.S. federal ku restricts this deuice to sale by or on the order of a physician. Warnings A warning representsthe possibi/it1 ofharm to the opemtor or patient. ' For proper operation, your concentrator rcquires unobstructed ventilation. The ventilation ports are located at the rear baseof the device and at the side air inlet filter. Keep the device at least 6 to l2 inches (15 to 30 cm) away from walls, furniture, and especiallycurtajns that could impcde adequate airflow to the device. Do not place rhe concentrator rn a small closed space (such as a closct). ' Do not remove the covers of this device. Servicing must be reFerredto an authorized and trained Respironics home care provider. . I n t h e e v e n t o f a n e q u i p m e n t a l a r r n o r i f y o u a r e e x p c r i e n c i n ga n y s i g n so f d i s c o m l o r t c o n s u l t y o u r h o m e c a r ep r o v i d e r a n d / o r y o u r h e a l t h c a r c p r o f c s s i o n a il n r m c d i a t e l v . ' C ) x y g e ng e n e r a t e db v t h i s c o n c e n t r a t o ri s s u p p l e m e n t a la n d s h o u l d n o t b e c o n s i d e r e dl i l e s u p p o r t i n g o r l i f e s u s t a i n i n g . in certain circumstancesoxvgen therapy c:rn be hazardor.rs; any user should seek medical advicc prioi to using this device. ' W'here the prcscribins he:rlth care professionalhas detcrmined that an interruption in the supply of oxygen, lor any reason. nlav havc scriotts coltsequenccsto the r:ser,an alternatc source oltoxygen should be available for immediate trse. ' C)xvgen vigttrottslv ircccleratcs combttstion and should be kepr away lrom hcat or open flame. Nor suitable for use in t h c p r e s e n c co f a f l a n r n r a l r l ca n e s t h c t i cm i x t u r e w i t h a i r o r w i t h o x v g e n o r n i t r o u s o x i d e . ' D o I t o t s n t o k c . r t l l o x o t h e r s t o s m o k e o r h a v e o p e n f l a m e s n e a r t h e c o n c e n t r a t o rw h e n i t i s i n u s e . ' D o n o t r : s eo i l o r g r c i l s co n t h c c o n c e n t r a t o ro r i t s c o m p o n e n t s a s t h e s es u b s t l r n c e sw, h e n c o m b i n e d ' " v i t h o x y g c n , c a n g r e a t h .i n c r e . r s et h c p o t c n t i r r lf b r a f l r e h a z a r da n d p e r s o n a li n j u r y . . D o n o r u s c t h c o x \ . ! r c . c o l ) c e n t r a t o ri f e i t h e r t h e p l u g o r p o w e r c o r d i s d a m a g e d .D o n o t u s e e x t e n s i o nc o r d s o r e l e c t r i c a la d a p t c r t . ' D o n o t a t t e n ) p t t o c l c , t n t h c c o n c c n t r a t o rw h i l e i r i s p l u g g e d i n r o a n e l e c t r i c a lo u t l e t . ' Device operation above or outsicle of thc voltage, I-PM, temperature, humidity and/or altitude valucs specified may d e c r e a s co x y g e n c o n c e nr r a t i o n l e v c l s . ' Your home care provider is rcsponsiblc fbr perfbrming appropriate preventive maintenancc at the intervals r e c o m m e n d e db y t h e d e v i c er n a n u i r r c t u r c r . Cautions A caution rel)r€sentsthe possibi/i4r oJ'damageto the equipment. . Do not placeliquidson or nearthe devicc. ' Ifliquid is spilledon the device,turn thc porveroffar.rdunplug from clectricaloutlet beloreattemptingto cleanup spill. Call your home careproviderif devicedoesnor conrinueto work properly. 4 AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual Chapter2: OperatingInstructions W'arning Do not use extension cords or ebctrical OxygenOutletPort adapters' Selecta iocation that allos's the concentrator to draw in room air without being restricted.\Iake sure that the deviceis at least6 to 12 inches (15 to l0 cm) arvav from walls, furniture, and especially curtains that could impede adequateairflow to the device. Do not t. place the device near any heat source. z. After reading this entire manual, plug the power cord into an electrical outlet. Do either Step A or Step B below. If you are not using a humidiffer, connect your nasal cannula to the Oxygen Outlet Port, as shown in the top illustration on the right. R, If you are using a humidifier, follow the stepsbelow: 1. Ope n the filter door on the back of the device as shown. 2. Remove the humidifier connector tube from the back of the n l t e r door and replacethe filter door, as shown. 3. Fill your humidifier bottle according to the manufacturer's instructions. 4. Mount the filled humidifier on the top of the EverFlo device inside the velcro strap, as shown in the illustration on the right. ^, Step 3-81 Tighten the velcro strap around the bottle and secureit so it is held firmly in place. Step 3-84 Conncct the humidifier connector tube (that you retrieved from the flltcr door) to the Oxygen Outlet Port (as shown in Step 3-A above). 7. Connect the other end of the humidifier connector tube to the top of the humidifier with the elbow in the tubing facing the fiont, as shown here. 8. Connect your cannula to the humidifier bottle according to the humidifier bottle manufacturer's specifications. ( /. ./, 3-87 Step AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual 4. Pressthe powerswitchto the On [] position.Initially,all the LEDs will illuminateand the audible alertwill beepfor a few seconds. After that time, only the greenLED shouldremainlit. you can begin breathingfrom the deviceimmediatelyeventhough it rypically takes l0 minutes ro reacho*ygen puriry specifications. ') 5. Adjust the flow to the prescribed setting by turning the knob on the rop of the flow meter unril the ball is centered on the line marking the specific flow rate. FlowMeter Knob 6. Be sure oxygen is flowing through the cannula. If it is not, refer to theTioubleshootine Guidc in this manual. 7. 8. Put on the cannula as directed by your home care provider. S(rhenyou are not using the oxygen concenrrarot pressthe power switch to the Off [O] position. AMSR oxygenconcentratorstore.com 1-877-774-9271 EverFloUserManual C h a p t e3r : C l e a n i n & g Maintenance W'arning: h is importailt to urtplug tlte deuice beforeyou perfonn any cleaning. Caution: Excessmoisture nta_yinpair the proper operation of the deuice. Cleaning Periodicalh'.use a damp cloth to wipe down the exterior caseof the EverFlo device. If you use medical disinfectants.be sure to follow the manufacturer'sinstructions. If you are using a humidifier, clean your device according to your home care provider's or manufacturer's instructions. Service The EverFloOxyger-r Concentratorconrainsno user-servicable parts. W'arning Do not remoae the couersof thb deuice. Seruicing must be referred to an authorized and trained Respironics home careprouider. Howto ContactRespironics Tb havc your device serviced,contact your home care provider. IFyou need to contact Respironicsdirectly, call the RcspironicsClustomerServicedepartmcnt at 1-800-345-6443(US and Canada only) or l-724-387-4000. You can :rlsousc the fbllowir-readdresscs: Rcspironrcs l(X)l \lurrv Ridge Lane \ l u r r v s v i l l e. l ) A l 5 ( 1 6 8 US,{ RespironicsDeutschland (lewerbcstrassc 17 82211 Herrsching Germany Visit thc EverFloweb site at: www.everflo.respironics.com AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual Chapter4: AlarmsandTroubleshooting Alarm and Indicators The device has an audible alarm and three LED indicators, as shown below. \ o \r"',o*.^.:':;[;]::::,'J:'*'' RedAlarm Indicator AudibleAlarm/ ColoredLED PossibleCause YourAction AllSLEDs illuminate continuously andthe Audible Alarm issounding continuously. Ihedevice hasdetected a system malfunction. lmmediately turnoffthedevice, connect t0a back upoxygen source, andcallyourhome care provider. Ihedevice isturned onbut isnotoperating. 0ften this TheAudible Alarm issounding continuously. indicates that the device isnot None ofthe LEDs areilluminated. plugged inorthereisa power failure. Iheckthepower outletandveri!thatthedevice isplugged in.lftheproblem continues, connect toa back upoxygen source andcallyourhome provider. care RedLED illuminates continuously andthe Audible Alarm issounding continuously. Thedevice hasdetected a system malfunction. lmmediately turnoffthedevice andwait5 minutes. Restart thedevice. lf thecondition persists turntheunitoff,conned toa back up oxygen source, andcallyourhomecareprovider. Yellow LED illuminates continuously. The RedLED isblinkingandtheAudible Alarmis periodically. beeping Ihedevice hasdetected animpeded oxygen flow condition. Follow thetroubleshooting guide onthenext page. Connect t0a back upoxygen source andcallyourhome provider care ifyour troubleshooting actions failtoendthisalert condition. Yellow LED illuminates c0ntinuously. TheRed LED isoffandtheAudible Alarm issilent. Thedevice hasdetected a low (0Plunits oxygen condition. only.) Continue usingtheunitbutcallyourhomecare provider about thiscondition. AMSR oxygenconcentratorstore.com 1-877-774-9271 EverFloUserManual Troubleshooting Guide Problem Why it Happened What to Do YellowLED isblinking. TheRedLED isoffandthe Audible Alarm periodically. isbeeping Turn theflowrate down toyour prescribed level. Wait at least 2minutes. Thedevice hasdetected a highoxygen lfthe condition persists turn the unitoff, flowcondition. (onnect toaback upoxygen sour(e, ano provider. callyour home care Green LED illuminates continuously. Theother LEDs areoffandtheAudible Alarm issilent. Ihedevice isturned onandworking properly. Take noaction. Thepower cordplugisnotproperly inserted intotheelectrical outlet. Make sure thedevice isproperly plugged intotheelectrical outlet. Thedevice isnotworkingwhenit isturnedon. Theunitisnotreceiving powerfrom (IheAudible Alarm issounding continuously. theelectrical outlet. AllLEDs areoff.) lnternal partfailure. (heck yourhousehold outletfuseor circuit. Connect toaback upoxygen source and your contact home provider. care Thedevice isnotworkingwhenit isturnedon. partfailure. lnternal (IheAudible Alarm issounding continuously andall3 LEDs areilluminated.) lmpeded oxygen flowindication isactivated. (IheYellow LED illuminates continu0usly, theRed LtDisblinking andtheAudible Alarm is beeping periodically.) Limited oxygen flowt0theuser without anv faultindication. (onnect t0aback upoxygen source and yourhome contad provider. care Theairflow tothedevice isimpeded orblocked. Remove anyitemsthatappear to be blocking theairflow intothedevice. Theflowmeterknobiscompletely closed. Iurntheflowmeter knob counterclockwise tocenter theballonthe prescribed LPM flow. Theoxygen tubingiskinkedano blocking thedelivery ofoxygen. Check to seethatthetubingisnotkinked orblocked. Replace if necessary. Theoxygen tubingorcannulais faulty. Inspect andreplace theitems if necessarv. There isa poor(onnection toa device Ensure (AllLEDs thatallconnections areoffandtheAudible arefreefrom Alarmissilent.) accesS0ry. leaks. AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual Chapter5: Specifications Environmental Operating Temperature 5 5t o9 0 ' F( 1 3t o3 2 "C) 15to 950/0, noncondensing Altitude 0toi500ft. (0to2286 m) Physical D i m e n s i o n s 2 2 . 8 i n . xi1n5. x 9 .i n 5 .( 5 8 c m x 3 8 c2m4xc m ) (14t0 w"igtrt | :t.o,oi: lbs. t5kg) = StandardsCompliance This device isdesigned toconform tothefollowing standards: - IEC - I Medical 60601 Electrica I Equipment, Part1: General Req uirement forSafety - 1EC60601-1-22ndedition,MedicalElectricalEquipment,Partl-2:6eneralRequirementforSafety-CollateralStandard:Electr - Requirements Compatibility andTests - lS083590xygen - Safety (oncentrators forMedical Use Requirements Electrical, AC Power Consumption Models1020000,I 020001 l20VAt+1070,350W,60Hz 1020002,1020003 1020004,1020005230VAC+10%,320W,60H2 1020006,1020007,I 020008 +100/0. 1 0 2 0 0 0 9 , 1 0 2 0 0 1230VAC 0 <300W 50Hz 1 0 2 0 0 1 ,1 0 2 0 0 1 2 l +1070, 10200013 230VAt <300W,60Hz 10 AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual Oxygen OxygenConcentration* (All Modelsexcept 90-9670 from 0.5t05LPM 10200007,1020008) tVtodels1O2OOOO7, 1O2OOO8 87-960/ofron0.5 to5 LPM Device oper:rrion ebovc or outside of the voltage, LPM, temperarure, humidiry and/or akirude values specificd nrl. rl.creaseoxygen concentration levels. Sound Level Models1020000,1020001 45dBAtypical 1020002,1020003 1020004,1020005 1020006,1020008 1 0 2 0 0 0 9 , 1 0 2 0 0 143 0 dBAtypical 1020011,1020012 10200013 1020007 <40dBAtypical Classification 'lhe . EverFloOrygen Concentratoris classified as: . IEC ClassII Equipment 'lyp. BF Applied Part . II)XI Drip I'roof ' Not suitableForusein the presence of a flammableanesthetic mixturewith air or with oxygenor nitrous oxrdc. . Clontinuous()peration Disposal Dispose of the devicc in accordancewith local regulations. WEEE/RoHS Recycling Directives If you are subject to the VEEE/RoHS recycling this product. recycling directives,refer to www.respironics.com for the passport for 1l AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual AppendixA: EMCInformation Gutoancenno ManurncruRER's Decunnnot - Et-gcrRomnctenc EmtssloNs: Thisdevice isintended forusernthe electromagneticenvironment specifiedbelow.The userof this deviceshould make sure it is usedin such an environment. ThedeviceusesRFenergyonlyfor itsinternalfunction.Therefore, its RFemissions areverylowandarenot likelyto causeanyinterference in nearbyelectronic equipment. The deviceis suitablefor usein all establishmenttincluding domestic establishmentsand those directly connected to the public low-voltage power supply network. Voltage fl uctuations/Flickeremitsions lEc 6100G3-3 'Ihis Gulonnce lno MnnuplcTURER'sDrclAmrton - Elrcrnomncnertc lmnnulttY! device isintended for usein the electromagnetic environment specified below. The user of this device should make sure it is used in such an environmcnt. ElectrostaticDischarge(ESD) tEc 61000<-2 Voltagedips,short interruptions andvoltage variations on powersupply inputlines tEc6r00M11 t6 kV contact rg kV air Floorsshould be wood, concrete or ceramic tile. lffloors are covered with synthetic material,the relative humidity should be at least 309o. t2 kVforpowersupplylines t1 kVforinput-output lines i2 kVforsupplymains tl kVforinpuvoutput lines Mainspower quality shouldbe that of a typical home or hospital environment- t1 kV differential mode i2 kV common mode 11 kV differential mode t2 kV for common mode Mainspower quality should be that ofa typical home or hospital environment. <5o/oU, (>95olodip in Ur) for 0.5 cycle 40o/oU, (60% dip in Ur) for 5 cycles 7@/oU, (30% dip in Ur) for 25 cycles <5oloUr (>950/odip in Ur) for 5 sec <57oU, (>95olodip in Ur) for 0.5 cycle WoU, (600/0 dip in Ur)for 5 cycles 7@/oU, (3070dip in Ur) for 25 cycles <5VoU, (>95olodip in Ur) for 5 sec Mainspowerqualityshould b€ that ofa typicalhome or hospitalenvironment.lf the user of the device requirescontinued operationduring power mainsinterruptions. it is recommended that the device be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levelscharacteristicofa typical location in a typicalhospitalor home environment. NOTE:Ur is the a.c.mains voltage prior to application ofthe test level. 12 AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual Gutonnce anoMlHurncruRER's Drcunnrron- ErecrRomncnerrc lunnururw: This device is inrended for use in e l e c t r o m a g n e t i ce n v i t o n m e n ! . t ( ! i : ! . 1 the : . . ! , 1 \ , l - . r l . c r , , i r h i s d e v i c es h o u l d m a k , r u r c i r i s u s e d i n r u c h r n c n v i r o n m e n t . Portableand mobile RFcommunicatons equlpment shouldbe used no closerto any pan of the dev ce,includingcables,than the recommendedseparationdlstancecalculatedfrom the equationapplicableto the frequencyofthe transmitter. ConductedRF lEc 610004{ 3Vrms 150kHzto 80MHz RadiatedRF IEC6l 000'1 l 3V/m 80MHzto 2.5GHz Recommended separation distance: '150 d = 1.2.rP k H zt o 8 0 M H z d = 1 . 2 . I F S 0 M H z t o S o oM H z d = 2 . 3 . J F 8 0 0M H z t o 2 . 5 G H z Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommendedseparationdistancein meters(m). Field strengths from fixed RFtransmitters,as determined by an electromagnetic site suruey a, shoul{ be lessthan the compliance levei-ineach frequency range b. Interferencemay occur in the vicinity of equipment marked with the following symbol:(1j.11) 'l' NOTE1: At 80 MHz and 800 MHz,the higherfrequencyrangeapplies. propagationis affectedby absorptionand reflectionfrom structuret NOTE2: Theseguidelinesmay not apply in all situations.Electromagnetic objects, and people. a: Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios.amateurradio,AM and FM radiobroadcastand W broadcastcannot be predictedtheoreticallywith accuracy. To assess the electromagneticenvironmentdue to fixed RFtransmitters, an electromagneticsitesurveyshouldbe considered.lfthe measuredfield strengthin the locationin which the deviceis usedexceedsthe applicableRFcompliancelevelabove,the deviceshould be observedto verifi7normaloperation.lf abnormalperformanceis observed,additionalmeasuresmay be necessary, suchas re orientingor relocatingthe device. b: Over the frequency range 150 kHz to 80 MHz,the field strengths should be lessthan 3 V/m. Recomnnrruoro SrpnnnrtonDrsrnruces BETwEEN PonrlsL: nNoMosrlr RFConanautrcATtoNs EeutpMENTANDTHts DgVtCf: Thc clevicc is intended for use in an electromegnetic cnvironnrenr in which ratliatecl RF disturbances are controlled. The customer or the user of this devicc can hclp prevent electromagnetic interference bv nraintaining a minimum distance between portable and mobile RF communicarions equipment (transmitters) and this dcvice rs reconrnrended l;elow, according to the maximum output power o1 rhe communicrtions equipmcnt. 1 5 0 K H zr o 8 0 M H z '1.2JF d= 8O MHz ro 800 MHz d = 1.2.rt 80O MHz ro 2.5 GHz d = 2.3.JF For transmitters rated at a maximum output power not listed above, the recommended separationdistance d in meters (m) can be e s t i m a t e du s i n gt h e e q u a t i o na p p l i c a b l et o t h e f r e q u e n c yo f t h e t r a n s m i t t e rw , h e r e P i s t h e m a x i m u m o u t p u t p o w e r r a t i n go f t h e transmitter in watts (W) according to the transmitter manufacturer N o t e 1 : A t 8 0 M H z a n d 8 0 0 M H z ,t h e s e p a r a t i o nd i s t a n c ef o r t h e h i g h e rf r e q u e n c yr a n g ea p p l i e s . Note 2:These guidelines may not apply in all situations.Electromagneticpropagation is affected by absorption and reflectionfrom structures,objects, and people. 13 AMSR oxygenconcentratorstore.com 1-877-774-9271 EverF/oUserManual LimitedWarranty Respironics, Inc. warrants that the system shall be free from defects of workmanship and materials and will perform in accordancewith the product specificationsfor a period ofthree (3) yearsfrom the date ofsale by Respironics, Inc. ro the dealer. Respironics warrants that the EverFlo units serviced by Respironics, or an authorized service cenret will be free from defects in serviced materials for a period of 90 days and free from are warranted defectsin workmanship for a period of 90 davs from the time of service.Respironicsaccessories to be free of defects in materials and workmanship for a period of 90 days from the time of purchase.If the product fails to perform in accordancewith the product specifications,Respironics,Inc. will repair or replace - at its option - the defective material or parr. Respironics,Inc. will pay customary freight chargesfrom Respironics,Inc. to the dealer location onll'. This warranry does not cover damage causedby accident, misuse, abuse,alteration, and other defects not relared to material or workmanship. Respironics,Inc. disclaims all liabiliw for economic loss, loss of profits, overhead,or consequentialdamages which may be claimed to arise from anv saleor use of this product. Some statesdo not allow the exclusion or limitation of incidental or consequentialdamages,so the above limitation or exclusion may not apply to you. This warranry is given in lieu of all other expressor implied warranties, including the implied warranties of merchantabiliry and fitness for a particular purpose. In addition, in no event shall Respironicsbe liable for lost profits, loss of good will, or incidental or consequentialdamages,even if Respironicshas been advised of the possibiliry of the same. Some staresor provinces do not allow the exclusion of limitation of implied warranties or the disclaimer of incidental and consequentialdamages.Accordingly, the laws of your state or province may give you additional protections. To exerciseyour rights under this warranry, contact your local authorized Respironics,Inc. dealer or contact Resoironics,Inc. at: Respironics 1001Murry fudgeLane Murrysville,PA 15668 USA Respironics Deutschland Gewerbestrassel7 8221I Herrsching 1-800-345-6443 +49815293060 Cermany r-724-387-4000 14 AMSR oxygenconcentratorstore.com 1-877-774-9271