Oxus Portable Oxygen Concentrator RS-00410 …The Portable Oxygen Concentratoris intended to deliver concentratedoxygen for adult patients with chronic pulmonary diseases such as chronic

iiiDL-00096 Rev. 6

Portable Oxygen Concentrator User Manual

ivDL-00096 Rev. 6

Manufactured by:Oxus, Inc.1685 Northfield DriveRochester Hills, Michigan 48309U.S.A.

0086

MDSS GmbHSchiffgraben 4130175 Hannover, Germany

The information in this document is subject to change without notice. This document contains proprietary information that is protected by copyright. No part of this document may be reproduced in any manner, in whole or in part (except for brief excerpts in reviews and scientific papers), without the prior written consent of Oxus. Be sure to read carefully and understand all manuals provided with the product.

For HelpIf you have questions about the information in these instructions or about the safe operation of this device, contact your distributor.

DL-00418 Rev. 2ii

Classification

This equipment is listed with a nationally recognized testing laboratory and classified with respect to electric shock, fire, and mechanical hazards in accordance with the following standards:

•EN60601-1(1990),MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety+A1(1993)+A2(1995)+A13(1996)

•UL60601-1(1stedition,2006-04-26),MedicalElectricalEquipment, Part1:GeneralRequirementsforSafety

•IEC60601-1(2ndedition),MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety,withA1andA2

•CAN/CSAC22.2No.601.1-M90(R2005),MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety

•IEC60601-1-4(2000-2004),Edition1.1ConsolidatedEdition,MedicalElectricalEquipment,Parts1-4:GeneralRequirementsforSafety–CollateralStandard:ProgrammableElectricalMedicalSystems

This equipment is classified as:

•ClassII

•TypeBF

•IPX2

•Continuousoperationattemperaturesof95°F(35°C)downto41°F(5°C),andshort-timeoperationfor25minutesattemperaturesupto104°F(40°C)and93%±2%relativehumidity.

iiiDL-00096 Rev. 12

iv DL-00096 Rev. 6

Explanation of Packaging and Labeling Symbols

Caution,consultaccompanyingdocuments

Input18VDC,6.7A

Output=87%-96%oxygen

Serial number

Catalognumber

U.S.federallawrestrictsthisdevicetosalebyor on the order of a physician

Nosmoking

Noopenflamewhendeviceisinuseordonotincinerate

Donotdisassemble

Separate collection for electrical and electronic equipment

TypeBFaccordingtoelectricalsafetyrequirements

Operatingatmosphericpressurelimitation0’to8,000’

Storagetemperaturelimitation-4°Fto140°F(-20°Cto60°C)

Humiditylimitation5%to93%±2%non-condensing

DL-00122Revision: 3 ECO 10180

Print Colors:Light Grey- Match GE Plast ics GY7D412 (Background), approx PMS427C Yellow- PMS 123C (Symbol)Black- PMS Process Black (Symbol & Text)Red- PMS 485C (Symbols)

6.7A

CAUTION:

3

Consult accompanying documents

Keep Dry

Do not Disassemble

No Oil Do Not Remove FilterWhen Unit is Operating

WARNING:

or Grease No

Smoking No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen

Usenooilorgrease



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen

iv DL-00096 Rev. 12

vDL-00096 Rev. 12

Donotuseifpackagingisdamaged

Handle with care

Dateofmanufacture

Manufacturernameandaddress



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen



6.7A

CAUTION:

3


Keep Dry

Do not Disassemble


WARNING:

or Grease No

Smoking No Open

Flame


= 87% - 96% Oxygen

Keepdry(ThissymbolreferstotheIPX2 classificationofthedevice)

Disposeofusedbatteryproperly

Donotremovefilterwhileunitisoperating

Medical EquipmentUL60601-1 CAN/CSA C22.2 No. 601.1

See Accompanying Documents3RUE

Medicalequipmentwithrespecttoelectricshock,fire,andmechanicalhazardsinaccordancewithUL60601-1,CAN/CSAC22.2No.601.1

WARNING!Donotusethisdevicewithoutthe carryingcase.Useofthisdeviceoutsideitscarryingcasemayresultinanelectricshockhazard.

CautionHotSurface

RochesterHills,MI48309

vi DL-00096 Rev. 12

Introduction

MANUAL VERSIONPleaserefertothismanualfordetailedinstructionsonwarnings,precautions,specifications,andadditionalinformation.PrintedinU.S.A.

GENERAL INFORMATIONThisusermanualprovidesinformationforusersofthePortableOxygenConcentrator.Forthesakeofbrevity,theterms“concentrator,”“unit,”or“device”aresometimesusedinthisdocumenttorefertothePortableOxygenConcentrator.

WARNING:

STATEMENTS THAT DESCRIBE SERIOUS ADVERSE REACTIONS AND POTENTIAL SAFETY HAZARDS.

PRECAUTION:

STATEMENTS THAT CALL ATTENTION TO INFORMATION REGARDING ANY SPECIAL CARE TO BE EXERCISED BY THE PRACTITIONER AND/ OR PATIENT FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE.

IMPORTANT:

Statements calling attention to additional significant information about the device or a procedure.

IMPORTANT:

Users should read this entire manual before operating the Portable Oxygen Concentrator. Failure to do so could result in personal injury and/or death. If you have questions about the information in this user manual or about the safe operation of this system, contact your distributor.

TYPOGRAPHICAL CONVENTIONSThese instructions contain warnings, precautions, and notes to help call attentiontothemostimportantsafetyandoperationalaspectsofthesystem.Tohelpidentifytheseitemswhentheyoccurinthetext,theyareshownusingthefollowingtypographicalconventions:

Note: Statements that provide supplemental information.

viiDL-00096 Rev. 12

INDICATIONS FOR USEThePortableOxygenConcentratorisintendedtoprovidesupplemental oxygeninahome,institutional,ortravelenvironment.

INTENDED USEThePortableOxygenConcentratorisintendedtodeliverconcentratedoxygenfor adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stage of cancer, or anypatientrequiringsupplementaloxygen.Thedeviceisportable,enablingpatientswhoneedanoxygendevicetobetreatedathomeaccordingtoa clinician’sprescriptionordirection.ThePortableOxygenConcentratorisa prescription-onlydevice,isnotintendedforuseinlife-supportingor life-sustainingsituations,andisprovidednon-sterile.Itisdesignedtobe usedindoorsoroutdoors.

CONTRAINDICATIONSThePortableOxygenConcentratorisnotintendedtobeused:

•inlife-supportingorlife-sustainingsituations •inanoperatingorsurgicalenvironment •withanon-adultpopulation •inconjunctionwithflammableanestheticorflammablematerials

viii DL-00096 Rev. 12

Warnings and Precautions

WARNINGS OVERVIEW

PRECAUTION:

1. U.S.FEDERALLAWRESTRICTSTHISDEVICETOSALEBYORONTHEORDEROFAPHYSICIAN.

2. ITISRECOMMENDEDANALTERNATESOURCEOFOXYGENBEAVAILABLEINCASEOFPOWEROUTAGEORMECHANICALFAILURE.CONSULTPROVIDERORCLINICIANFORANAPPROPRIATEBACKUPSYSTEM.

3. NON-PRESCRIBEDOXYGENTHERAPYCANBEHAZARDOUSUNDERCERTAINCIRCUMSTANCES.USETHISDEVICEONLYWHENPRESCRIBEDBYACLINICIAN.

PRECAUTIONS OVERVIEW

WARNING:

1. CRITICAL! EXPLOSION HAZARD. DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS!

2. DO NOT USE A PORTABLE OXYGEN CONCENTRATOR OR ANY ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE.

3. DO NOT ALLOW SMOKING OR OPEN FLAMES NEAR THIS DEVICE. DO NOT USE THIS DEVICE IN THE PRESENCE OF POLLUTANTS OR FUMES.

4. DO NOT SUBMERGE THIS DEVICE IN LIQUID. DO NOT EXPOSE TO WATER OR PRECIPITATION. DO NOT EXPOSE TO DUSTY CONDITIONS.

5. DO NOT USE LUBRICANTS ON THIS DEVICE OR ANY OF ITS ACCESSORIES.

6. ALWAYS ENSURE BATTERY IS INSERTED BEFORE USING THIS DEVICE.

7. IF FEELING ILL OR EXPERIENCING DISCOMFORT WHILE USING THIS DEVICE, CONTACT CLINICIAN IMMEDIATELY.

8. DO NOT DISASSEMBLE THIS DEVICE OR ANY OF ITS ACCESSORIES. DO NOT ATTEMPT ANY MAINTENANCE OTHER THAN TASKS DESCRIBED IN “TROUBLESHOOTING” (PAGE 20). DISASSEMBLY CAN CREATE AN ELECTRIC SHOCK HAZARD AND WILL VOID THE WARRANTY. CONTACT CUSTOMER SERVICE FOR SERVICING BY AUTHORIZED PERSONNEL.

9. RISK OF ELECTRIC SHOCK. DO NOT OPERATE THIS DEVICE WITHOUT THE CARRYING CASE.

10. THIS DEVICE IS FOR CONTINUOUS OPERATION AT TEMPERATURES OF 95°F (35°C) DOWN TO 41°F (5°C), AND SHORT-TIME OPERATION FOR 25 MINUTES AT TEMPERATURES UP TO 104°F (40°C) AND 93% ± 2% RELATIVE HUMIDITY.

ixDL-00096 Rev. 12

PRECAUTION:

4. IFYOUAREUNABLETOHEARORSEEALARMS,DONOTHAVENORMALTACTILESENSITIVITY,ORCANNOTCOMMUNICATEDISCOMFORT,CONSULTCLINICIANBEFOREUSINGTHISDEVICE.

5. THISDEVICEISNOTDESIGNEDFORUSEWITHAHUMIDIFIERORNEBULIZER.IFAHUMIDIFIERORNEBULIZERISUSEDWITHTHISDEVICE,PERFORMANCEMAYBEDIMINISHEDANDTHEDEVICEMAYBEDAMAGED.

6. PATIENTSWITHAFASTBREATHINGRATEREQUIRINGAHIGHEROXYGENSETTINGMAYREQUIREMOREOXYGENTHANTHISDEVICECANPRODUCE.THISDEVICEMAYNOTBEAPPROPRIATEINTHATCASE.CONSULTCLINICIANFORALTERNATIVETREATMENT.

7. ONLYUSEAPPROVEDACCESSORIESWITHTHISDEVICE.REFERTOTHEAPPROVEDACCESSORIESGUIDEFORACOMPLETELISTOFACCESSORIESANDCANNULAAPPROVEDFORUSEWITHTHISDEVICE.USINGUNAPPROVEDACCESSORIESORCANNULAMAYIMPAIRTHEPERFORMANCEOFTHISDEVICE.

8. REPLACETHECANNULAONAREGULARBASIS.CHECKWITHyourdistributorORCLINICIANTODETERMINEHOWOFTENTHECANNULASHOULDBEREPLACED.

9. ELECTRICALCORDAND/ORTUBINGLYINGONTHEFLOORCOULDPRESENTATRIPPINGHAZARD.

10.NEVERLEAVETHISDEVICEINAHOTENVIRONMENT.NEVERLEAVETHISDEVICEINALOW-TEMPERATUREENVIRONMENT.EXTREMEHIGHORLOWTEMPERATURESCANDAMAGETHISDEVICE.

11.IFOXYGENCONCENTRATIONDROPSBELOWTHESPECIFIEDLEVEL,ANALARMWILLINDICATETHISCONDITION.IFALARMPERSISTS,STOPUSINGTHISDEVICE,SWITCHTOANALTERNATESOURCEOFOXYGEN,ANDCONTACTCUSTOMER SERVICE.

12.DONOTUSECLEANINGAGENTSOTHERTHANTHOSE SPECIFIEDINTHISMANUAL.ALLOWTHECLEANINGSOLUTIONTODRYFROMTHECLEANEDSURFACEBEFOREUSE.

13.ALWAYSDISCONNECTPOWERANDTURNOFFTHISDEVICEBEFORECLEANING.SEE“MAINTENANCEANDCLEANING”(PAGE12).

14.DONOTOBSTRUCTAIRINTAKEOREXHAUSTWHENOPERATINGTHISDEVICE.BLOCKAGECANCAUSEBUILDUPOFINTERNALHEATANDSHUTDOWNORDAMAGETHISDEVICE.

15.ALWAYSUSEINAWELL-VENTILATEDLOCATION.

16.DONOTOPERATETHISDEVICEWITHOUTTHEINPUTFILTERINPLACE.IFFILTERISREMOVED,PARTICLESMAYBEDRAWNINTOTHESYSTEMANDMAYDAMAGETHISDEVICE.

x DL-00096 Rev. 12

PRECAUTION:

17.ALWAYSOPERATEDEVICEATTHESETTINGPRESCRIBEDBYACLINICIAN.DONOTALTERTHESETTINGUNLESSPRESCRIBEDBYACLINICIAN.

18.THISDEVICEISDESIGNEDFORUSEBYONEPATIENTATATIME.

19.THISDEVICEMAYNOTREACHSPECIFIEDOXYGEN CONCENTRATIONPURITYUNTILITHASBEENINUSEFORUPTO10MINUTES.

20.ALWAYSFOLLOWTHEMAINTENANCESCHEDULEASSPECIFIEDIN“ROUTINEMAINTENANCE”(PAGE13).

21.IFTHISDEVICEINDICATESANABNORMALCONDITION,SEE“TROUBLESHOOTING”(PAGE20).

22.REMOVEBATTERYIFTHISDEVICEISNOTGOINGTOBEUSEDFORMORETHANSEVENDAYS.STOREBATTERYINACOOL,DRYPLACE.

23.ALWAYSFOLLOWCANNULAMANUFACTURER’SINSTRUCTIONSFORPROPERUSE.

24.ALWAYSTURNOFFTHISDEVICEWHENNOTINUSE.

25.DONOTUSETHISDEVICEWHILESLEEPINGUNLESSUNDERTHESUPERVISIONOFACLINICIAN.

26.DONOTPLACEOBJECTSONTOPOFTHISDEVICE.

27.THISDEVICEISRATEDIPX2.DONOTUSEINDUSTYCONDITIONS.

28.USECAUTIONWHENTOUCHINGTHISDEVICEINHIGHAMBIENT TEMPERATURES.

29.CHECKTHATTHISDEVICEOPERATESONBATTERYAFTER DISCONNECTINGFROMTHEPOWERSOURCE.

30.ONLYCHARGEBATTERYINTHISDEVICEORINANAPPROVEDCHARGER.(SEEAPPROVEDACCESSORIESGUIDE.)

IMPORTANT:

1. If an extension cord is necessary, use a UL listed 15 amp or higher cord. Do not connect any other devices on the same extension cord.

2. Inhale through nose for the concentrator to work most effectively. Inhaling through mouth may result in less effective oxygen therapy.

3. This device utilizes an oxygen-conserving delivery method, and the setting on this device may differ from your setting on a continuous flow oxygen concentrator (if you have been prescribed one). Your clinician will provide you with specific instructions based on your specific health condition and other variables.

xiDL-00096 Rev. 12

Contents

Classification........................................................................................ iiiExplanationofPackagingandLabelingSymbols................................. ivIntroduction.......................................................................................... vi ManualVersion............................................................................. vi GeneralInformation...................................................................... vi TypographicalConventions........................................................... vi IndicationsforUse........................................................................vii IntendedUse.................................................................................vii Contraindications...........................................................................viiWarningsandPrecautions...................................................................viii WarningsOverview......................................................................viii PrecautionsOverview..................................................................viiiBeforeYouGetStarted.........................................................................1 PowerSupply.................................................................................... 1 ChargingtheBattery...................................................................... 2FeaturesandControls........................................................................... 4 Accessories....................................................................................6 CarryingCase.......................................................................... 6 PullCart................................................................................... 7OperatingthePortableOxygenConcentrator...................................... 9 ConnectingNasalCannula................................................................ 9 TurningOn........................................................................................10 AdjustingSetting..............................................................................10 RespondingtoAlarms......................................................................11 TurningOff.......................................................................................11 TravelingbyAirWiththePortableOxygenConcentrator................11MaintenanceandCleaning..................................................................12 VerifyingtheAlarmSystem.............................................................12 BatteryCare.....................................................................................12 Environment/Storage.......................................................................12 RoutineMaintenance.......................................................................13 CleaningandChangingFilters......................................................13 InputFilter..............................................................................13 PatientFilter...........................................................................14 CompressorFilter...................................................................14 ExteriorCleaning..............................................................................15 AccessoryCleaning..........................................................................15 DeviceRepair...................................................................................15

xii DL-00096 Rev. 12

DeviceDisposal....................................................................................15AlarmIndicators...................................................................................16 Alarms..............................................................................................16 CriticalHighPriorityAlarms..........................................................16 HighPriorityAlarms......................................................................17 MediumPriorityAlarms................................................................17 LowPriorityAlarms......................................................................18 OtherMessages...........................................................................18Troubleshooting...................................................................................20Appendix1:TechnicalDescription...................................................... 21Appendix2:TechnicalInformation......................................................22Trademarks..........................................................................................25Disclaimer............................................................................................25AirlineTravelGuidelines......................................................................26

Before You Get Started

Alwaysinspectthedeviceanditsaccessoriesforanysignofdamagebeforeusing.

Note: While box or packaging may exhibit some damage, e.g., tears or dents, the device may still be in a usable condition.

Ifthedeviceoranyaccessoryshowsanysignofdamage,contactyourcareprovider.

Beforeyougetstarted,checktomakesureyouhavethefollowing:

•Concentrator •Battery •Carryingcase •AC/DCpowersupply

SeeApprovedAccessoriesGuideformoreinformation.

WARNING:

DO NOT USE A PORTABLE OXYGEN CONCENTRATOR OR ANY ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE.

POWER SUPPLYThePortableOxygenConcentratorcanalwaysbeusedwhendirectly connectedtoapowersource.However,toenhanceitsportability,thePortableOxygenConcentratorisequippedwitharechargeablelithium-ioninternalbattery.

WARNING:

ALWAYS ENSURE BATTERY IS INSERTED BEFORE USING THIS DEVICE.

1DL-00096 Rev. 12

Note: Optional power supplies are available for various global use and travel. See Approved Accessories Guide for complete list.

2 DL-00096 Rev. 12

Charging the Battery

PriortousingthePortableOxygenConcentratorforthefirsttime,installthebatteryasshowninFigure1.Thebatterywilllatchwhenfullyseated.

PRECAUTION:

ONLYCHARGEBATTERYINTHISDEVICEORINANAPPROVEDCHARGER.(SEEAPPROVEDACCESSORIESGUIDE.)

ConnecttheACpowersupply(consultApprovedAccessoriesGuide)byplugging the round connector into the receptacle on the side of the concen-trator.SeeFigure2.PlugtheotherendoftheACpowersupplyintoapoweroutlet.Alwaysusecautionwheninsertingthepowersupplytoawalloutlet.

Chargerrequirementsareuniversaltosupportawidevarietyofinternationalmarkets,soitcanbepluggedintoanoutletwith100-240VAC,50-60Hz.Allowthebatterytochargeforaminimumofthreehoursbeforeuse.Oncethebatteryiscompletelycharged,thedevicecanrunonbatteryforapproxi-mately4hoursatasettingof2.0.

Note: Battery run time may vary based on breathing rate, age of battery, and environmental conditions. See displayed text on device for battery charge status.

Figure 1.

DL-00096 Rev. 12 3

Figure 2.

Note: Ensure power status icon (see Figure 6, page 5) indicates power is connected. If not, check that cord is plugged in completely. (See “Troubleshooting” on page 20 for more information.)

Tomaximizebatterylifeandruntime,usewhileconnectedtoapowersourcewheneverpossible.Theinternalbatterywillautomaticallychargewhenevertheconcentratorisconnectedtoapowersource.TheLCD displaywillindicatewhetherthedeviceisoperatingonbatteryorexternalACpower.

Thefullychargedbatterywillretainsomelevelofchargeforuptosevendaysinthisdevicewhennotinuse.

Note: Battery damage may result if the concentrator’s battery is allowed to discharge completely.

PRECAUTION:

REMOVEBATTERYIFTHISDEVICEISNOTGOINGTOBEUSEDFOR MORETHANSEVENDAYS.STOREBATTERYINACOOL,DRYPLACE.

PRECAUTION:

CHECKTHATTHISDEVICEOPERATESONBATTERYAFTER DISCONNECTINGFROMTHEPOWERSOURCE.

Note: When not using the battery inside the unit, be sure to store it in the protective sleeve that was provided with the original package.

4 DL-00096 Rev. 12

Display screen

Features and Controls

Figure 3.

Figure 4.

Power key – turns device on or off

Previous/next key – changes setting

Display percentbattery charge

Alarm mute key – temporarily silences audible alarms or shows the last highest priority alarm

Cannula port

Green LED – indicates device is on

Yellow LED – indicates caution or attention required

Red LED – indicates a warning of danger and/or a need for urgent action

Alarm mute indicator – indicates alarm buzzer has been muted

Power supply port

Patient filter

Exhaust

5DL-00096 Rev. 12

Figure 5.

Input filter

Battery

Compressor filter

Air intake

Power status (battery)

Power status (external)

Figure 6.

Setting

Setting

Some models do not require a compressor filter

6 DL-00096 Rev. 12

ACCESSORIESAvarietyofaccessoriescanenhancetheportabilityanduseofthePortableOxygenConcentrator.Inadditiontothedevice,thepackagecontains accessoriestogetstartedandinstructionsforuse.RefertotheApprovedAccessoriesGuideforthecompletelistofavailableaccessories.

Only use a nasal cannula with the following specifications:

•7’(2.1m)or25’(7.6m)long •Highflow •Three-fluted •Crush-resistant •Largeinternaldiameterbore •Straightnon-taperedtips •Suitableforupto15lpmNote: Recommended model is Salter Labs 1600 HF cannula.

PRECAUTION:

ONLYUSEAPPROVEDACCESSORIESWITHTHISDEVICE.REFERTOTHEAPPROVEDACCESSORIESGUIDEFORACOMPLETELISTOFACCESSORIESANDCANNULAAPPROVEDFORUSEWITHTHISDEVICE.USINGUNAPPROVEDACCESSORIESORCANNULAMAYIMPAIRTHEPERFORMANCEOFTHISDEVICE.

Contactyourdistributorforupdatedinformationandaccessoriesorif additional,optional,orreplacementaccessoriesareneeded.

Carrying CaseToreducetheriskofelectricshock,alwaysusethePortableOxygenConcentratorwithacarryingcase(whichalsofurtherreducesthedevicenoiseduringoperation).Insertthedeviceinthecasesuchthatthedisplayscreenisvisiblethroughtheclearplasticwindowandsecurelyfastenallstraps.Whenproperlyinserted,itshouldlooklikeFigure7.Whenusingthecarryingcase,donotcarrytheconcentratorbyitshandle;usethecase’scarryingstrap.

WARNING:

RISK OF ELECTRIC SHOCK. DO NOT OPERATE THIS DEVICE WITHOUT THE CARRYING CASE.

7DL-00096 Rev. 12

Figure 7.

Pull CartWhenusingthePortableOxygenConcentratorwithapullcart,attachandsecuretheconcentratorwiththestrapsasshowninFigure8.Thehandlecanbepulledoutandadjustedforcomfort.

Figure 8.

Note: It is recommended that patients use the pull cart to transport the device whenever possible.

8 DL-00096 Rev. 12

Intentionally blank

9

Operating the Portable Oxygen Concentrator

DL-00096 Rev. 12

ThePortableOxygenConcentratorisdesignedforeaseofuse,withall functionsaccessedthroughjustafewkeysonthecontrolpanel.

ThePortableOxygenConcentratorshouldbecarriedinitscarryingcase,placedonacart,orusedwhilelayingonatableoruprightonthefloor.Thepatientshouldbewithintherecommendedcannulalengthduringuse.

Note: Except during startup and shutdown sequences, the backlight on the display screen will remain off. Pressing any key will turn the backlight “on” briefly. The backlight will also remain activated during an un-muted alarm condition.

CONNECTING NASAL CANNULA PRECAUTION:

REPLACETHECANNULAONAREGULARBASIS.CHECKWITH YOURDISTRIBUTORORCLINICIANTODETERMINEHOWOFTENTHECANNULASHOULDBEREPLACED.

PRECAUTION:

ALWAYSFOLLOWCANNULAMANUFACTURER’SINSTRUCTIONSFORPROPERUSE.

Connectthetubingtothecannulaport(oxygendischarge)asshowninFigure9.

Figure 9.

IMPORTANT:

Read “Warnings and Precautions” (page viii) before using this device.

10 DL-00096 Rev. 12

Toconnectthecannulatothepatient,positionthecannulatipsinpatient’s nostrilsandpasstubingoverbothearsandunderchin.Followmanufacturer’sinstructions.

Slideadapteruptubingtoadjustforcomfortandfit.

Oncethecannulaissecured,breathenormallythroughthenose.ThePortableOxygenConcentratorwilldetectabreathanddelivertheoxygenduringinhalation.

Note: Improper cannula placement may result in the Portable Oxygen Concentrator being unable to detect all respiratory efforts of the patient. Ensure cannula is connected securely and it has been fully inserted.

PRECAUTION:

PATIENTSWITHAFASTBREATHINGRATEREQUIRINGAHIGHER OXYGENSETTINGMAYREQUIREMOREOXYGENTHANTHISDEVICECANPRODUCE.THISDEVICEMAYNOTBEAPPROPRIATEINTHATCASE.CONSULTCLINICIANFORALTERNATIVETREATMENT.

TURNING ONToturnthePortableOxygenConcentratoron,pressthepowerkey.Theconcentratorwillchirpandthegreen,yellow,andredLEDswillflashonce,whilethescreendisplaysconcentratorsoftwareversioninformationandtotalelapsedruntimeinformation.ThegreenLEDwillthenstaylit.

Note: No adjustments can be made until the startup sequence is completed.

ADJUSTING SETTINGNote: After powering on the Portable Oxygen Concentrator, the startup sequence will take approximately 35 seconds. Specified oxygen level will be reached within 10 minutes of use.

Increaseordecreasethesettingusingtheprevious/nextkey.Pressingthenext(+)keyincreasesthesetting0.5,upto5.0.Pressingtheprevious(-)keydecreasessetting0.5,downto1.0.

Thecurrentsettingandpowersource(externalpowerorbattery;batteryiconalsoshowsapproximatelevelofchargeremaining)areshownonthedisplayscreenasshowninFigures10and11.

Figure 10. Concentrator operating on battery power.

11DL-00096 Rev. 12

Figure 11. Concentrator running on external power.

RESPONDING TO ALARMS

PRECAUTION:

IFYOUAREUNABLETOHEARORSEEALARMS,DONOTHAVE NORMALTACTILESENSITIVITY,ORCANNOTCOMMUNICATE DISCOMFORT,CONSULTCLINICIANBEFOREUSINGTHISDEVICE.

Pressingthealarmmutekeyatanytimewillsilencethebuzzer.Thelengthofthemuteperioddependsontheseverityofthealarm.(See“AlarmIndicators”onpage16.)Duringthismuteperiod,themuteLEDwillremainilluminated,indicatingthealarmbuzzerismuted.Pushthemutekeyagaintounmutealarms.Pressingthemutekeywhenthereisnoactivealarmwillmuteanyfuturemediumorlowpriorityalarmsforeighthours.See“Troubleshooting”(page20)foradditionalinformationonalarms.

TURNING OFF

PRECAUTION:

ALWAYSTURNOFFTHISDEVICEWHENNOTINUSE.

ToturnthePortableOxygenConcentratoroff,pressandholdthepowerkey.Thedevicewillchirpandthescreenwilldisplayashutdownmessage“Shuttingoff”forapproximatelyfiveseconds,thengointolow-powermode.Note: Do not disconnect the AC power supply and remove the battery at the same time while the unit is running. Always use the power key to turn the device off. Wait until the device has completely shut down before disconnecting from power and removing the battery.

TRAVELING BY AIR WITH THE PORTABLE OXYGEN CONCENTRATORContactyourdistributorforinformationonairlineregulationsrelatedto travelingwiththePortableOxygenConcentratorbyair.

12 DL-00096 Rev. 12

Maintenance and Cleaning

VERIFYING THE ALARM SYSTEMAtstartup,theLEDsshouldlightupandbuzzershouldsoundtoverify operation.

BATTERY CAREAvoidlettingbatterydeplete;operatedevicewhenconnectedtoACpowerwheneverpossibletohelpkeepbatterycharged.Disconnectbatteryifthedevicewillnotbeusedformorethansevendays,andstorethebatteryinacool,dryplace.

Disposeofbatteryaccordingtolocalregulationsorcontactyourdistributor.

ENVIRONMENT/STORAGEThePortableOxygenConcentratorcanoperateinthefollowingconditions:

•41°Fto95°F(5°Cto35°C) •5%to93%±2%relativehumidity(non-condensing) •Altitudesbetween0’to8,000’abovesealevel(0kmto2.4km)

Whennotinuse,thePortableOxygenConcentratorshouldbestoredinaclean,dryenvironmentbetween-4°Fand140°F(-20°Cand60°C).Note: The Portable Oxygen Concentrator can be safely stored up to 15,000’ (4,572 m) above sea level.

PRECAUTION:

NEVERLEAVETHISDEVICEINAHOTENVIRONMENT.NEVERLEAVETHISDEVICEINALOW-TEMPERATUREENVIRONMENT.EXTREMEHIGHOR LOWTEMPERATURESCANDAMAGETHISDEVICE.

PRECAUTION:

REMOVEBATTERYIFTHISDEVICEISNOTGOINGTOBEUSEDFORMORETHANSEVENDAYS.STOREBATTERYINACOOL,DRYPLACE.

WARNING:

THIS DEVICE IS FOR CONTINUOUS OPERATION AT TEMPERATURES OF 95°F (35°C) DOWN TO 41°F (5°C), AND SHORT-TIME OPERATION FOR 25 MINUTES AT TEMPERATURES UP TO 104°F (40°C) AND 93% ± 2% RELATIVE HUMIDITY.

13DL-00096 Rev. 12

ROUTINE MAINTENANCE

WARNING:

DO NOT USE LUBRICANTS ON THIS DEVICE OR ANY OF ITS ACCESSORIES.

PRECAUTION:

REPLACE THE CANNULA ON A REGULAR BASIS. CHECK WITH YOUR DISTRIBUTOR OR CLINICIAN TO DETERMINE HOW OFTEN THE CANNULA SHOULD BE REPLACED.

Devicewillindicatewithanalarmwhenafilterordeviceneedstobecleanedorchanged.(Also,see“Troubleshooting”onpage20.)

Cleaning and Changing FiltersFiltersinthePortableOxygenConcentratorshouldbeperiodicallywashedorreplacedasindicatedbymessagesonthedisplayscreen.

INPUTFILTERTheinputfilterisdesignedtokeepparticlesoutofthedeviceandshouldbewashedfrequently,especiallyifusedinacontaminatedenvironment(suchasnearconstructionsites,etc.).Note: If a replacement input filter is required, contact your distributor.

PRECAUTION:

DONOTOPERATETHISDEVICEWITHOUTTHEINPUTFILTERINPLACE. IFFILTERISREMOVED,PARTICLESMAYBEDRAWNINTOTHESYSTEMANDMAYDAMAGETHISDEVICE.

PRECAUTION:

ALWAYSDISCONNECTPOWERANDTURNOFFTHISDEVICEBEFORECLEANING.

Wash the input filter by following these steps:

1.Removethefilterfromthedevice. 2.Rinseundertapwaterwithoutsoap. 3.Airdry.

14 DL-00096 Rev. 12

PATIENTFILTERThepatientfilterisdesignedtotrapairborneparticulates.Ifthedevice indicates the patient filter should be replaced, contact your distributor for replacementfilter.ReplaceasshowninFigure12.

Figure 12.

COMPRESSORFILTERThecompressorfilterisdesignedtotrapairborneparticulates.Ifyourdevicehasacompressorfilter,thedevicewillindicatewhenthecompressorfiltershouldbereplaced,contactyourdistributorforreplacementfilter.ReplaceasshowninFigure13.

Figure 13.

Some models do not require a compressor filter.

15DL-00096 Rev. 12

EXTERIOR CLEANING

WARNING:

DO NOT SUBMERGE THIS DEVICE IN LIQUID. DO NOT EXPOSE TO WATER OR PRECIPITATION. DO NOT EXPOSE TO DUSTY CONDITIONS.

PRECAUTION:

DO NOT USE CLEANING AGENTS OTHER THAN THOSE SPECIFIED IN THIS MANUAL. ALLOW THE CLEANING SOLUTION TO DRY FROM THE CLEANED SURFACE BEFORE USE.

Cleantheexteriorwithasoftclothslightlydampenedwithsoapywateroramixtureof10%householdbleachinwater.

ACCESSORY CLEANINGRefertotheoriginalcannulamanufacturer’sinstructionsforcleaningthenasalcannula.

DEVICE REPAIRDonotattempttorepairthedevice.Contactyourdistributorforassistance(see“Troubleshooting”onpage20).

DEVICE DISPOSALContactyourdistributorregardingdisposalofthedevice.

16 DL-00096 Rev. 12

IfthePortableOxygenConcentratordetectsanalarmcondition,itwillindi-catethealarmvisuallyandaudiblywithin10seconds.Therearefourlevelsofalarms:criticalhighpriority,highpriority,mediumpriority,andlowpriority.Eachisindicateddifferentlybythebacklitdisplay;green,yellow,andredLEDs;andbuzzer,asindicatedbelow.Ineachcase,thealarmmessageandpowerstatuswilloverridethecurrentdisplay.Note: All alarm conditions and parameters are factory preset; conditions and parameters cannot be changed or adjusted by the user.

Alarm Status

Criticalhigh priority

High priority

Mediumpriority

Lowpriority

Audible Tone

Ten beeps per burst, burst repeatsevery3seconds

Ten beeps per burst, burst repeatsevery3seconds

Three beeps per burst, burstrepeatsevery8 seconds

Three beeps per burst, burstrepeatsevery 10minutes

Visual Indicator

SolidredLED (anddeviceshuts offautomatically)

FlashingredLED

FlashingyellowLED

SolidyellowLED

Note: If two alarm conditions exist at the same time, the highest priority alarm is indicated. If two or more alarm conditions of equal priority exist at the same time, the most recent one will be displayed.

Note: The most recent alarms indicated by the device are logged for reference by service personnel. This log is maintained even if the device is powered down or if power is lost for any other reason.

Note: If the mute key is pressed prior to an alarm condition (for example, to mute the device in a movie theater), critical high priority and high priority alarms will override the mute function; medium and low priority alarms will be muted for eight hours from the time the key was pressed. Press the mute key off to display the last highest priority alarm. Press the mute key on again to reset the eight-hour timer.

ALARMSWhenthePortableOxygenConcentratorsoundsanalarm,acorrespondingmessagewillbedisplayedonthescreen.Takeappropriateactionasdirectedinthechartsbelow.

Critical High Priority AlarmsNote: These alarms will disable the Portable Oxygen Concentrator immediately.Alarm Message

ChargeBattery

Alarm Indicators

Mute Time

20minutes

20minutes

8hours

24hours

Action

Recharge the battery pack by plugging in to power supply.Ensureallconnec-tionsaremadesecurely.

Description

Batteryneedscharging.

Alarm Message

CheckC-filtr

Description

Deviceisunabletomain-tain pressure

Action

Checkthatthecom-pressor filter is fully installed.Thearrowson the filter should line up with the arrows on theconcentrator.Ifthealarm persists, contact yourdistributor.

17DL-00096 Rev. 12

Alarm Message

CheckVents

LowBattery

XX:Service!*

*Value:21-50

Description

Deviceisunabletomaintain oxygenpurity.

Estimatedbatterylifelessthan17minutes.

Servicerequired.

Action

Besureairinlet/outlethasnotbeenblocked.If alarm persists, contact yourdistributor.

Chargethebatterypackby plugging in to power supply.

Note: The message will be automatically cleared when plugged in to power supply.

Contactyourdistributor.

High Priority AlarmsNote: These alarms will allow the Portable Oxygen Concentrator to continue operating.

Alarm Message

CheckCannula

XX:Service*

*Value:51-70

Description

Nobreathdetectedfor2minutes.

Servicerequired.

Action

Checkthecannulacon-nection.Besuretobreathethroughnose.Ifalarm persists, contact yourdistributor.

Note: The message will be automatically cleared when breathing is detected.


Medium Priority Alarms

XX:Service!*

*Value:01-20

Servicerequired. Contactyourdistributor.

18 DL-00096 Rev. 12

Alarm Message

ReplaceC-filtr

ReplaceP-filtr

WashI-filtr

Replace batt XX:Service*

*Value:71-99

Description

Compressorfilterneedsreplacement.

Patientfilterneeds replacement.

Inputfilterneedstobecleaned.

Mainbatteryhasexceeded300rechargecycles.

Servicerequired.

Action

Replacefilter.Pressandhold mute key for more than4secondstoresetthehourcounter.

Replacefilter.Pressandhold mute key for more than4secondstoresetthehourcounter.

Washinputfilter.Pressand hold mute key for morethan4secondsto resetthehourcounter.

Contactyourdistributorforreplacement.

Note: This alarm will be automatically cleared once a new battery is inserted. Battery will continue to function after 300 recharge cycles, but for a shorter time than a new battery.


Low Priority Alarms

Other Messages

Message

Powerremoved

SWVerN.NNN

Self test

Shutting off

Externalpower

Description

Externalpowerhasbeendisconnected; unit is now runningonbattery.

Displayofsoftwareversionduring startup and calibra-tion.ThisincludestestofbeeperandLEDs.

Indicatesunitisgoingthroughitstestatstartup.Displayedforapproximately 10seconds.

Displayedwhileunitgoesthroughitspower-downsequence.

Externalpoweris connected.

Action

Noactionisrequired.

Noactionisrequired.

Noactionisrequired.

Noactionisrequired.

Noactionisrequired.

19DL-00096 Rev. 12

Message

Batterylow

Fullycharged

Checkingpower

Nobattery

BattLifeNN%

Charging:NN%

Charging

RTXXXXX

BreathrateXX

Alarm cleared

Description

Estimatedbatterylifelessthan17minutes.Theunitwill also generate a high priority alarm as described above.

Displayedasthebatterymenu item when the batteryis100%charged.

Displayedasthebatterymenu item when the battery status has recently changed and the unit software is analyzing the changeinstatus.

Displayedasthebatterymenu item when there are no communications with thebattery.

Displayedpercentageofbattery charge if at least 10%andthereisno externalpowerconnected.

NN%displaysthecur-rentbatterychargelevel.Displayedwhenbatterychargeisgreaterthan10%butlessthan100%andthereisexternalpowerconnected.

Batterychargeislessthan10%andthereisexternalpowerconnected.

Non-resettabletotalelapsedtimeindicator(hours).

Thepatient’saveragebreathrate whenthedeviceisdeliveringthemaximumamountofoxygenandthe bolusisreduced.Ifnobreaths are detected, the most recent breath rate is shown.

Apreviouslysetalarmhasbeenautomaticallycleared.

Action

Chargethebatterypackby plugging in to power supply.

Noactionisrequired.

Noactionisrequired.

Verifythatthebat-tery pack is correctly installed.Contactyourdistributor if the battery is fully inserted and the message continues to be displayed longerthan30seconds.

Messageisdisplayedwhen mode key is pressed.



Noactionrequired.

Reduceactivitylevel.Besureairinlet/outlethasnotbeenblocked.

Note: The message will automatically clear when the device returns to normal operation.

Noactionrequired.

Other Messages, continued

Note: The message will be automatically cleared when plugged in to power supply.

20 DL-00096 Rev. 12

Problem

System becomes inoperative

Any alarm sound or either

Batterynotcharging

Possible Cause

•Systemmaybe disconnected from the powersource.

•Systemmaybeturnedoff.

•Criticalhighpriorityalarmhasoccurred.

•See“AlarmIndicators”onpage16.

•Powerisnotconnected.

•Batteryisnotfullyinserted.

•Batteryisinoperable.

Troubleshooting

•Checkthatthesystemis connected securely tothepowersource.

•Ensurethesystemispoweredon.

•Examinethesystemfordamageorexpo-suretoliquids.

•Ifproblempersists,contact your distribu-tor.

•See“Alarms”on page16.

•Checkconnectionstoensure:

1.Roundreceptacles aresecureinunit.

2.Powercordis connected to AC/DCsupplyor automotiveDC adapter is connected, ifapplicable.

3.Powercordis connected to wall outlet,ifapplicable.

4.Walloutlethas power.

•Ensurebatteryisfullyseated and latch is secure.

•Ifproblempersists,contact your distribu-tor.

(red)or

(yellow)LEDlit

Troubleshooting

21DL-00096 Rev. 12

Appendix 1: Technical Description

Size: 7.6”Wx5.6”Dx11.9”H(192mmWx142mmDx302mmH)

Unit weight: Lessthan10lbs(withoutcarryingcaseorcart)

Power requirements: 100-240VAC(±10%),50-60Hz;batterypower18VDC,6.7amps;DCadap-tor,18VDC,6.7amps(Note: See Approved Accessories Guide for model and part number of AC power supply.)

Purity: 87%-96%(22°C±3°C,14.29psia±0.04or739mmHgat40%±15%relativehumidity)at all flow rates

Setting: Useradjustable1.0to5.0(with0.5increments)(min.1.0;max.5.0)

Setting indicator: LCDdisplay

Maximum oxygen discharge pressure:20.5psiatsettingof5.0

Humidity range: 5%to93%±2%non-condensing

Operating altitude: 0’to8,000’relativetosealevel(0kmto2.4km)

Sound pressure level (measured 1 m from edge of chassis):Lessthan42dB(A)average

Type of protection (electrical): ClassI

Degree of protection (electrical): TypeBF

Degree of protection (water):IPX2

Degree of safety (flammable anesthetic mixture): Notsuitableforuseinthepresenceofaflammableanestheticmixture

Operation: Continuousoperationattemperaturesof95°F(35°C)downto41°F(5°C),andshort-time operationfor25minutesattemperaturesupto104°F(40°C).

Alarm sound pressure range: 65to85dB(A)

Alarm system delays: Lessthan10secondsafterdetection(lowoxygenalarmsifoxygenislessthan82%volumefractionatspecifiedenvironmentalconditions)

Oxygen concentrator status indicator:Highpriorityalarmthatindicateswhenoxygenconcentrationdropsbelow82%

Maximum Temperature:Underextremeenvironmentalandoperatingconditions,specificmaxi-mumsurfacetemperaturesarelistedbelow.Eachofthesespecificsurfacesalsolistsanexpecteduser contact limit as follows:

TheKeypanelcanreachupto140°F(60°C).Thissurfaceisintendedtobetouchedforlessthanoneminuteatatime.Theclearplasticwindowonthecarryingcasecanreachupto118.4°F(48°C).Thissurfaceisintendedtobetouchedforlessthantenminutesatatime.Theremainderofthecarryingcasecanreachupto109.4°F(43°C).Thissurfacehasnotimelimitationonusercontact.

22 DL-00096 Rev. 12

Appendix 2: Technical Information

ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATIONMedicalelectricalequipmentrequiresspecialprecautionsregarding electromagneticcompatibility(EMC).Portableandmobileradiofrequency(RF)communicationsequipmentcanaffectdevicessuchasthePortableOxygenConcentrator.Assuch,thedeviceshouldnotbeusedadjacenttoother equipment.Ifthisisnotpractical,thenobservethedevicetomakesureitisoperatingproperlyatalltimes.

Emissions test

RFemissions CISPR11

RFemissions CISPR11

Harmonic emissions IEC61000-3-2

Voltagefluctuations/ flicker emissions IEC61000-3-3

Compliance

Group1

ClassB

ClassA

Complies

Electromagnetic environment/guidance

ThePortableOxygenConcentratorusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowand are not likely to cause any interference innearbyelectronicequipment.

The concentrator is suitable for use in all establishments, including domestic establishments and those directly connected tothepubliclow-voltagepowersupplynetwork that supplies buildings used for domesticpurposes.

Guidance and manufacturer’s declaration: electromagnetic emissionsThePortableOxygenConcentratorisintendedforuseintheelectromagnetic environmentspecifiedbelow.Thecustomerortheuseroftheconcentratorshouldassurethatitisusedinsuchanenvironment.

23DL-00096 Rev. 12

Immunity test

Electrostatic discharge(ESD) IEC61000-4-2

Electricfast transient/burst IEC61000-4-4

Surge IEC61000-4-5

IEC 60601 test level

±6kVcontact±8kVair

±2kVforpower supply lines ±1kVforinput/outputlines

±1kV differential mode ±2kVcommon mode


Floorsshouldbewood,concrete,orceramictile.Iffloorsarecoveredwithsynthetic material, the relativehumidityshouldbeatleast30%.

Mainspowerqualityshould be that of a typical commercial or hospital environment.

Mainspowerqualityshould be that of a typical commercial or hospital environment.

Guidance and manufacturer’s declaration: electromagnetic immunityThePortableOxygenConcentratorisintendedforuseintheelectromagnetic environmentspecifiedbelow.Thecustomerortheuseroftheconcentratorshouldassurethatitisusedinsuchanenvironment.

Compliance level

±15kVcontact±8kVair

±2kVforpower supply lines ±1kVforinput/outputlines

±1kV differential mode ±2kVcommon mode

24 DL-00096 Rev. 12

Immunity test

Voltagedips,shortinterruptions, and voltagevariationson power supply input lines IEC61000-4-11

Powerfrequency(50/60Hz)magnetic field IEC61000-4-8

ConductedRF IEC61000-4-6

RadiatedRF IEC61000-4-3

IEC 60601 test level

<5%UT (>95%dipinUT) for0.5cycle

40%UT (60%dipinUT) for5cycles


<5%UT (>95%dipinUT) for5sec

3A/m

3Vrms150kHzto80Mhz

20V/m80Mhzto2.5Ghz


Mainspowerqualityshouldbe that of a typical commercial or hospital environment.IftheuserofthePortableOxygenConcentratorrequired continued operation during power main interruptions, it is recommended that the concentrator be powered from an uninterruptible powersupplyorbattery.

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristic of a typical commercial or hospital environment.

PortableandmobileRF communications equipment should be used no closer toanypartofthePortableOxygenConcentrator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d=1.2√Pd=1.2√P80MHzto800MHz

d=2.3√P800MHzto2.5GHz

wherePisthemaximum output power rating of the transmitterinwatts(W)according to the transmitter manufacturer and d is the recommended separation distanceinmeters(m).

FieldstrengthsfromfixedRFtransmitters,asdeter-mined by an electromagnetic sitesurveya should be less thanthecompliancelevelin each frequency rangeb.Interferencemayoccurinthevicinityofequipmentmarkedwith the following symbol:

Compliance level

<5%UT (>95%dipinUT) for0.5cycle



<5%UT (>95%dipinUT) for5sec

3A/m

3Vrms

20V/m

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio (cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcast,andTVbroadcastcannotbepredictedtheoretical-lywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichthePortableOxygenConcentratorisusedexceedstheapplicableRFcompliancelevelabove,theconcentratorshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingtheconcentrator.bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

25DL-00096 Rev. 12

Rated maximum output power of transmitter (W)

0.01

0.1

1

10

100

150 kHz to 80 MHz d=1.2√P

0.12

0.38

1.2

3.8

12

Recommended separation distances between portable and mobile RF communications equipment and the Portable Oxygen Concentrator

ThePortableOxygenConcentratorisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.Themonitorusercanhelpprevent electromagnetic interference by maintaining a minimum distance between portable and mobileRFcommunicationsequipment(transmitters)andthemonitorasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Separation distance (m) according to frequency of transmitter

80 MHz to 800 MHz d=1.2√P

0.12

0.38

1.2

3.8

12

800 MHz to 2.5 GHz d=2.3√P

0.23

0.73

2.3

7.3

23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistance(d)inmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects, and people.

Disclaimer

Theinformationinthisdocumenthasbeencarefullyexaminedandisbelievedtobereliable.Furthermore,Oxusreservestherighttomakechangestoanyproductshereintoimprovereadability,function,ordesign.Oxusdoesnotassume any liability arising out of the application or use of any product or cir-cuitdescribedherein;neitherdoesitcoveranylicenseunderitspatentrightsnortherightsofothers.

Trademarks

Alltrademarksarethepropertyoftheirrespectiveowners.

Airline Travel Guidelines

26 DL-00096 Rev. 12

Whentravelingbyair,itisrecommendedtheguidelineslistedbelow be followed:

1. Thepatientmustbecapableofseeingthealarmindicatorlights,hearingthevariouswarningalarms,andtakingtheappropriateactionsshouldtheunitfailtodetecttheuser’sbreathingorageneralmalfunctionoccurs.Ifthepatientisnotcapableoftheaboverequirement,theymustbetravelingwithsomeonewhoiscapableofperformingthosefunctionsfortheuser.

2. PersonusingthePortableOxygenConcentrator(POC)mustnotbeseatedinanaisle,normalexitrow,oremergencyexitsoasnottorestrictaccesstotheaislebyotherpassengers.PatientsshouldstowPOCwhileinuse,underneathseat,sothatitdoesnotinterferewiththemovementofotherpassengers.Ifpatientsarenotrequiredtouseoxygenduringtakeoff,landing,ormovementonthesurface,theymuststowthePOCaccordingtoairlineregulations(underneathseatorinoverheadcabin).

3. Patientisresponsibletocarrysufficientamountofbatteriestolastfortheentiretrip,includinglayoversand/orpossibleflightdelays.

4. Batteries,notbeingusedorextra,mustbestowedintheirprotectivecoveror/andplacedinsidethecarryingcaseorplacedinsideanapprovedcarry-onbaggage,packagedtopreventshortcircuitsandprotectedfromphysicaldamage.

5. Patientmustobtainasigned,licensedclinicianstatementthatmedicaloxygenisnecessaryforthedurationoftheflightandthemaximum settingallowedonboardanaircraft.

6. ThepatientmustinformtheaircraftoperatoranditscrewthatthePOCmaybeusedonboardtheaircraft.

7. Intheeventofanalarm,thePOCmustbeturnedofforalarmsmuted.8. Onlyoxygenapprovedlotionsorsalvesmaybeusedbythepatient.9. ThepatientmustoperatethePOCwithbatterypoweronly(donotuse

thecarcharger)whileonboardtheaircraft.TheA/Cpowercordandcarchargeroptionsarenotapprovedforonboardaircraftuse.

Intentionally blank

DL-00418 Rev. 2 27

Oxus, Inc.1685 Northfield DriveRochester Hills, Michigan 48309U.S.A.Tel: 888.475.1568

E-mail: [email protected]

All trademarks are the property of their respective owners.

©2012 Oxus, Inc. All rights reserved. DL-00418 Rev. 2