oxus portable oxygen concentrator rs-00410 …the portable oxygen concentratoris intended to deliver...
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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
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
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
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
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
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
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
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
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
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
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
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
Usenooilorgrease
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
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
iv DL-00096 Rev. 12
vDL-00096 Rev. 12
Donotuseifpackagingisdamaged
Handle with care
Dateofmanufacture
Manufacturernameandaddress
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
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
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
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.
Contactyourdistributor.
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.
Contactyourdistributor.
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.
Messageisdisplayedwhen mode key is pressed.
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
Electromagnetic environment/guidance
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
70%UT (30%dipinUT) for25cycles
<5%UT (>95%dipinUT) for5sec
3A/m
3Vrms150kHzto80Mhz
20V/m80Mhzto2.5Ghz
Electromagnetic environment/guidance
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
40%UT (60%dipinUT) for5cycles
70%UT (30%dipinUT) for25cycles
<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
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