Transcription

USER MANUALWhere will you go NEXT?1

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Table of ContentsChapter 1Chapter 2Chapter 3Chapter 4Chapter 5Chapter 6Chapter 7Chapter 8Glossary of Symbols1IntroductionIntended UseContraindications and General PrecautionsCautions and Warnings2222Description of the OxyGo NEXT Oxygen ConcentratorUser ControlsUser InterfacesInput/Output Connection5556Operating InstructionsGeneral InstructionsPower Supply OptionsOxyGo NEXT AccessoriesTraveling with OxyGo NEXT6681012Audible and Visible Signals12Troubleshooting18Cleaning, Care and MaintenanceCannula ReplacementOxyGo NEXT Column Change Procedure191920SpecificationsDisposal of Equipment and Accessories2324

1. Glossary of SymbolsSymbol KeyONLYType BF Applied PartCompliant with the WasteElectrical and ElectronicEquipment/Restrictionof the Use of CertainHazardous Substances inElectrical and ElectronicEquipment (WEEE/RoHS)recycling directiveClass II DeviceKeep DryNo Open Flames(Concentrator); Do notincinerate (Battery).Indoor or Dry LocationUse Only, Do Not Get WetU.S. Federal RegulationRestricts this Device toSale by order of Physician.May also be applicable inother CountriesONLY ONLYAC PowerNo smokingDC PowerONLYNo oil or greaseDo Not DisassembleElectrical Safety AgencyCertificateThe manufacturer of thisPOC has determined thisdevice conforms to allapplicable FAArequirements for POCcarriage and use on boardaircraft.1Refer to instructionmanual/booklet.ManufacturerThis symbol indicates useof the automobile DC inputpower cable (1400-1050)

2. IntroductionIntended UseThe OxyGo NEXT Oxygen Concentrator is usedon a prescriptive basis by patients requiringsupplemental oxygen. It supplies a highconcentration of oxygen and is used with anasal cannula to channel oxygen from theconcentrator to the patient. The OxyGo NEXTmay be used in home, institution, vehicle andvarious mobile environments.Cautions and WarningsCautions A caution indicates that a precautionor service procedure must be followed.Disregarding a caution could lead to aminor injury or damage to equipment. Additional monitoring or attentionmay be required for patients using thisdevice who are unable to hear or seealerts or communicate discomfort. If thepatient shows any signs of discomfort,a physician should be consultedimmediately. The OxyGo NEXT is not designed orspecified to be used in conjunctionwith a humidifier, nebulizer orconnected with any other equipment.Use of this device with a humidifier,nebulizer or connected with any otherequipment may impair performanceand/or damage the equipment. Do notmodify the OxyGo NEXT Concentrator.Any modifications performed on theequipment may impair performance ordamage equipment and will void yourwarranty. Do not use oil, grease, or petroleumbased products on or near the OxyGoNEXT. Do not use lubricants on the OxyGoNEXT or its accessories. Never leave the OxyGo NEXT in anenvironment which can reach hightemperatures, such as an unoccupiedcar in high temperature environments.This could damage the device. Avoid touching the recessed electricalcontacts of the External Battery Charger;damage to contacts may affect chargeroperation. Do not obstruct air intake or exhaustwhen operating the device. Blockageof air circulation or proximity to aheat source may lead to internal heatbuildup and shutdown or damage to theconcentrator.Intended LifeThe expected life for the OxyGo NEXT OxygenSystem is 5 years, with the exception of thesieve beds (metal columns) which have anexpected life of 1 year and the batteries,which have an expected life of 500 fullcharge/discharge cycles.Contraindications andPrecautions This device is NOT INTENDED to be lifesustaining or life supporting. Under certain circumstances, the use ofnon-prescribed oxygen therapy can behazardous. This device should be usedonly when prescribed by a physician. USA Federal law restricts this device tosale by or on the order of a physician.May also be applicable in othercountries. Nasal cannula should be rated for 6 litersper minute (e.g. Salter Labs 16SOFT) toensure proper patient usage and oxygendelivery. Availability of an alternate source ofoxygen is recommended in case ofpower outage or mechanical failure.Consult your equipment provider fortype of back-up system recommended. It is the responsibility of the patient tomake back-up arrangements foralternative oxygen supply whentraveling; OxyGo assumes no liabilityfor persons choosing not to adhere tomanufacturer recommendations.2

The OxyGo NEXT Concentrator isdesigned for continuous use. Foroptimal sieve bed (columns) life, theproduct should be used frequently. Do not operate the OxyGo NEXT withoutthe particle filter in place. Particlesdrawn into the system may damage theequipment. The OxyGo NEXT battery acts as asecondary power supply in the eventof a planned or unexpected loss of theAC or DC external power supply. Whenoperating the OxyGo NEXT from an ACor DC external power supply, a properlyinserted OxyGo NEXT battery should bemaintained in the unit. This procedurewill ensure uninterrupted operation andwill operate all alerts and alerts in theevent of a loss of the external powersupply.Ensure the power supply is in a wellventilated location as it relies on aircirculation for heat dissipation. Thepower supply may become hot duringoperation. Make sure the power supplycools down before handling. Do not disassemble the power supply.This may lead to component failureand/or safety risk. Do not place anything in the powersupply port other than the suppliedwall cord. Avoid the use of electricalextension cords with the OxyGo NEXT. Ifan extension cord must be used, use anextension cord that has an UnderwritersLaboratory (UL) Mark and a minimumwire thickness of 18 gauge. Do notconnect any other devices to the sameextension cord. To ensure oxygen flow, ensure that thenasal cannula is properly connected tothe nozzle fitting and that the tubing isnot kinked or pinched in any way. Replace the nasal cannula on a regularbasis. Check with your equipmentprovider or physician to determine howoften the cannula should be replaced.3 The OxyGo NEXT is designed to providea flow of high purity oxygen.An advisory alert, “Oxygen Low”, willinform you if oxygen concentrationdrops. If alert persists, contact yourequipment provider. Ensure the power supply is poweredfrom only one power source (AC or DC)at any given time. Ensure the automobile power socket isclean of cigarette ash and the adapterplug fits properly, otherwise overheatingmay occur. Do not use the power supply witha cigarette plug splitter or with anextension cable. This may causeoverheating of the DC power inputcable. Do not jump start the automobile withthe DC power cable connected. This maylead to voltage spikes which could shutdown and/or damage the DC powerinput cable. When powering the OxyGo NEXT in anautomobile ensure the vehicle’s engineis running first before connecting DCcable into cigarette lighter adapter.Operating the device without theengine running may drain the vehicle’sbattery. A change in altitude (for example, fromsea level to mountains) may affect totaloxygen available to the patient. Consultyour physician before traveling to higheror lower altitudes to determine if yourflow settings should be changed.Warnings A warning indicates that the personalsafety of the patient may be involved.Disregarding a warning could result ininjury. The device produces enriched oxygengas, which accelerates combustion. Do not allow smoking or open flameswithin 10 feet of this device while in use.

Avoid use of the OxyGo NEXT inpresence of pollutants, smoke or fumes.Do not use the OxyGo NEXT in presenceof flammable anesthetics, cleaningagents or other chemical vapors. Do not submerse the OxyGo NEXTor any of the accessories in liquid. Do not expose to water or precipitation.Do not operate in exposed rain. Thiscould lead to electrical shock and/ordamage. Do not use cleaning agents other thanthose specified in this User Manual.Do not use alcohol, isopropyl alcohol,ethylene chloride or petroleum basedcleaners on the cases or on the particlefilter. Never leave the OxyGo NEXT in anenvironment which can reach hightemperatures, such as an unoccupiedcar in high temperature environments.This could damage the device. Do not use power supplies, powercables or accessories other than thosespecified in this user manual. The useof non-specified power supplies, powercables or accessories may create asafety hazard and/or impair equipmentperformance. Do not wrap cords around power supplyfor storage. Do not drive, drag or placeobjects over cord. Doing so may lead todamaged cords and a failure to providepower to the concentrator. To avoid danger of choking orstrangulation hazard, keep cords awayfrom children and pets. If you begin to feel ill or are experiencingdiscomfort while using this device,consult your physician immediately. Ensure that the automobile powersocket is adequately fused for theOxyGo NEXT power requirements(minimum 10Amp, preferred 15Amp).If the power socket cannot support a10Amp load, the fuse may blow or thesocket may be damaged. The tip of the Cigarette Adapter Plugbecomes HOT when in use. Do not touchthe tip immediately after removal froman auto cigarette lighter socket. It is the responsibility of the patientto periodically check the battery andreplace as necessary. OxyGo assumesno liability for persons choosingnot to adhere to manufacturerrecommendations. Audible notifications, ranging from68dBA to 78dBA depending on theusers position, are to warn the userof problems. To insure that audiblenotifications may be heard, themaximum distance that the user canmove away from it must be determinedto suit the surrounding noise level.Make sure the OxyGo NEXT is in alocation where the alerts can be heardor will be recognized if they occur. Do not use any columns other thanthose specified in this user manual.The use of non-specified columns maycreate a safety hazard and/or impairequipment performance and will voidyour warranty. Do not disassemble the OxyGo NEXT orany of the accessories or attempt anymaintenance other than tasks describedin this user manual; disassembly createsa hazard of electrical shock and willvoid your warranty. Do not remove thetamper evident label. For events otherthan those described in this manual,contact your equipment provider forservicing by authorized personnel.4

3. OxyGo NEXT Oxygen Concentrator Description285413User Controls76ItemDescriptionFunction1ON / OFF ButtonPress once to turn “ON”; Press and hold for one second to turn “OFF”.2Flow SettingControl ButtonsUse the – or flow setting control buttons to select the setting as shownon the display. There are six settings, from 1 to 6.3Volume ControlButtonPressing this button will change the volume level, from 1 to 4.4Audible AlertButtonPressing this button will toggle the OxyGo NEXT’s breath detectionaudible alert on and off.Breath Detection Alert Mode. The OxyGo NEXT will alert with audible andvisual signals for “no breath detected” when this mode is enabled and nobreath has been detected for 60 seconds.At 60 seconds, the device will enter into auto pulse mode and onceanother breath is detected, the device will exit auto pulse mode anddeliver normally on inspiration. The display’s mode indication area willshow a bell icon, flashing yellow light and display message when the alertis enabled.If power is lost, the breath detection audible alert remains set in the userpreferred mode.User Interfaces5ItemDescriptionFunction5DisplayThis screen displays information regarding flow setting, power status,battery life and errors. Display appearance will vary. Before use, removethe static cling FCC label from the screen.6Indicator LightsA green light indicates breath detection. A yellow light indicates either achange in operating status or a condition that may need response (alert).A flashing light is higher priority than non-flashing.7Audible SignalsAn audible signal (beep) indicates either a change in operating status ora condition that may need response (alert). More frequent beeps indicatehigher priority conditions. The default volume is set at level 1 and can beadjusted to higher settings but it can not be silenced. If power is lost, theaudible signal remains set in the user preferred adjusted setting.8BacklightA backlight will illuminate the screen for 15 seconds when the on/offbutton is briefly pressed.

Input / Output ConnectionsParticle FilterThe filters mustbe in place at theintake ends ofIntakethe concentrator Ventduring operationto keep input airclean.Cannula NozzleFittingIntakeVentThe nasal cannulaconnects to thisnozzle for OxyGoNEXT output ofoxygenated air.DC Power InUSB PortConnection forexternal powerfrom the AC powersupply or DC powercable.For service use only.4. Operating InstructionsGeneral Instructions1.Place the OxyGo NEXT in a wellventilated location.1., 2., 3.2.Air intake and exhaust must have clearaccess. Locate the OxyGo NEXT in sucha way that any auditory alerts may beheard. Always operate the OxyGo NEXTin an upright position (see image forproper orientation).IntakeVent3.Ensure particle filters are in place at bothends of device.4.Insert the OxyGo NEXT battery by slidingbattery into place until the latch returnsto the upper position.5.IntakeVentExhaustVent4.Connect the AC input plug to the powersupply. Connect the AC power plugto the power source and connect thepower output plug to the OxyGo NEXT.The green LED on the power supply willbe illuminated and a beep will soundfrom the concentrator.6

6.Connect the nasal cannula tubingto the nozzle fitting. Nozzle fitting islocated on the top of the OxyGo NEXT.Use of a single lumen cannula up to25 feet in length is recommended toensure proper breath detection andoxygen delivery. Additional titrationmay be needed to ensure properoxygen delivery when using a particularcannula, consult your physician.7.Turn on your OxyGo NEXT by pressingthe ON/OFF Button. A single short beepwill sound after poweing on. Pleasewait icon