Patient ManualFocusTMPortableOxygen ConcentratorDO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READINGAND UNDERSTANDINGTHIS MANUAL. IF YOU ARE UNABLETO UNDERSTAND THE WARNINGS ANDINSTRUCTIONS, CONTACT YOUREQUIPMENT PROVIDER BEFORE ATTEMPTING TO USETHIS EQUIPMENT; OTHERWISE, INJURY OR DAMAGECAN RESULT.NO SMOKING signs should be prominently displayed in thehome or wherever Focus is in use. Proper informationabout the dangers of smoking in the presence of medical oxygen should be relayed.English: A multilingual version of the manual (MN172-1) is available through your Equipment Provider.Español: Una versión multilingüe del manual (MN172-1) está disponible a través de su proveedor de equipo.Français: Une version multilingue du manuel (MN172-1) est disponible par l'intermédiaire de votre fournisseur de matériel.Deutsche:Eine mehrsprachige Version des Handbuchs(MN172-1) ist in Ihrer Geräte-Anbieter.TABLE OF CONTENTSAirSep®FocusTM PortableOxygen ConcentratorAirSep’s FocusTM PortableOxygen Concentrator 1Symbols 1-2Why Your Physician Prescribed Oxygen 2What is the Focus PortableOxygen Concentrator? 3Important Safety Rules 4-7Getting Started with YourFocus Portable Oxygen Concentrator8-11Battery Charging 12Optional AirBelt / Charging theOptional AirBelt 13-15Nasal Cannula16-17Focus Unit Components 17Operating Instructions 18Power Supplies 19TABLE OF CONTENTSAirSep®FocusTM PortableOxygen ConcentratorAudible Alarm and Indicator Lights20-21How to Respond to Focus’sAudible Alarm andIndicator Lights 22Cleaning, Care, and Proper Maintenance 23Cabinet23Carrying Bag23Focus Accessories 24Reserve Oxygen Supply 24Troubleshooting 25-26Focus Specifications 27Classification 28Limited Warranty 29MN170-1 rev A 03/111AirSep’s FocusTMPortable Oxygen ConcentratorThis Patient Manual will acquaint you with AirSep’s FocusTM Portable Oxygen Concentrator (POC). Make sure you read andunderstand all the information contained in this manual beforeyou operate your Focus unit. Should you have any questions, yourEquipment Provider will behappy to answer them for you.SymbolsSymbols are frequently used onequipment and/or the manual in preference towords with the intention of decreasing thepossibility of misunderstanding caused by language differences. Symbols can also permit easier comprehension of a conceptwithin a restricted space.The following table is a list of symbols and definitionsused with the Focus Portable Oxygen Concentrator.SymbolDescriptionSymbolDescriptionON (power switch on)OFF (power switch off)Warning –Describes a hazard or unsafepractice that if not avoided can result insevere bodily injury, death or propertydamageClass II Equipment, double insulatedCaution –Describes a hazard or unsafepractice that if not avoided can result inminor bodily injury or property damageComplies with the 93/42/EEC directivedrawn up by the approved organizationNo. 0459Note – Provides information importantenough to emphasize or repeatSafety agency for CAN/CSA C22.2 No.601.1 M90 for medical electricalequipmentConsult the accompanyingdocumentsKeep unit and accessories dryUse no oil or greaseProper disposal of waste of electrical andelectronic equipment requiredMN170-1 rev A 03/112No smokingDo not disassembleType BF equipmentConsult instructions for useOxygen outlet connection to thecannulaDo not expose to open flamesCaution: Federal law (USA) restrictsthis for sale or rental by or on the orderof a physician or licensed health careprovider.Do not block fanMethod of disposing of waste:All waste from AirSep’s FocusOxygen Concentrator must be disposed of using the appropriatemethods specified bylocal authorities.Method for disposing of the device:In order to preserve the environment, the concentrator must be disposedof using the appropriatemethods specified bylocal authorities.Why Your Physician Prescribed OxygenMany people suffer from a variety ofheart, lung, and other respiratory diseases. A significant number of these patients can benefitfrom supplemental oxygen therapy at home,when traveling, or while participating in daily activities away from home.Oxygen is a gas that makesup 21% of the room air we breathe. Our bodies depend ona steady supply tofunction properly. Yourphysician prescribed a flow or setting to address your particularrespiratory condition.Although oxygen is a non-additive drug, unauthorized oxygen therapy can be dangerous. You mustseek medical advice before you usethis oxygen concentrator. The Equipment Provider who supplies your oxygen equipment will demonstrate how to operate the FocusPortable Oxygen Concentrator.MN170-1 rev A 03/113What is the Focus PortableOxygen Concentrator?Oxygen concentrators wereintroducedin the mid-1970sand have become the most convenient,reliable source of supplemental oxygenavailable today. Oxygen concentrators are the most cost-effective, efficient, and safest alternative to using high-pressure oxygencylinders or liquidoxygen. An oxygen concentrator provides all the oxygen you need with no cylinder or bottledeliveries required.The air we breathe contains approximately21% oxygen, 78% nitrogen, and 1%other gases. In the Focus unit, room air passes througha regenerative, adsorbent materialcalled molecular sieve. This material separates the oxygen from thenitrogen. The result isa flow ofhigh-concentration oxygen deliveredto the patient.Focus combines advanced oxygen concentrator technology with oxygen conserving technology for the world’s smallestand lightestportable oxygen concentrator at just1.75 lb (0.8 kg).The unit efficiently produces its ownoxygen, and quickly delivers it as a pulseof oxygen at the very beginning ofyour inhalation. This eliminatesthe waste associated with acontinuous flow oxygen device thatdelivers oxygen evenwhile you are exhaling. Focus produces the equivalent of2 LPM (liters per minute)continuous flow oxygenin a lightweight package that patientscan wear easily away from the home.Focus operates fromfourdifferent power sources. (Refer to thePower Supplies section of this manual.)MN170-1 rev A 03/114----[Read the Important Safety Rules section before operating this equipment.]----Important Safety RulesCarefully review and familiarize yourself with the followingimportant safety information about the portable Focus OxygenConcentrator.This device supplies high-concentration oxygen that promotes rapid burning. Do not allow smoking or open flameswithin five feet (1.5 m) of this device, or any oxygen-carrying accessory. Failure to observe this warning can result insevere fire, property damage, and/or cause physical injury or death.If you feel discomfort or are experiencing a medicalemergency, seek medical assistance immediately.This unit is not to be used for life support. Geriatric, pediatric, or any other patients unable to communicate discomfortwhile using this unit may require additional monitoring. Patients with hearing and/or sight impairment(s) may needassistance with monitoring alarms.Use no oil, grease, or petroleum-basedor other flammable products on the oxygen carrying accessories or the Focusunit. Oxygen accelerates the combustion of flammable substances.The incorrect use of the Focus battery can cause the batteryto get hot, ignite, and may cause serious injury. Be surenot to pierce, strike, step on, or dropthe battery, or otherwise subject thebattery to strongimpacts or shocks.While using the Focus unit outdoors with the AC powersupply, connect the power supply into a Ground FaultInterrupted (GFI) outlet only to preventaccidental electrical shock hazard.Electrical shock hazard. Disconnect the power cord fromthe electrical outlet before you clean the unit to preventaccidental electrical shock hazard. Onlyyour Equipment Provider or a qualified service technician should remove thecovers or service the unit.MN170-1 rev A 03/115Care should be taken to prevent Focus from getting wet or allowing water to enter the unit. This can cause the unit tomalfunction or shut down.Federal (USA) law restricts this device to sale orrental by order of a physician or other licensedhealth care provider.In the event of an alarm or you observethat Focus is not working properly; consult the Troubleshooting section in thismanual. If you cannot resolve the problem, consult your Equipment Provider.The Focus Portable Oxygen Concentrator may be used during sleep under the recommendation of a qualified clinician.Operating the Focus unit outside of its normal operating temperature range can affect performance and decreasebattery run time and/or increase battery charge time. (Refer to the Specifications section in this manual.)Do not allow either the air intake or the air outlet vents tobecome blocked. This can cause the Focus unit to overheatand affect performance.Do not operate unit in a restricted or confined space (i.e.,a small case or handbag) where ventilation can be limited.This can cause the Focus unit to overheat and affect performance.Storing the Focus unit outside of its temperature specifications may affect performance. (Refer to the Specificationssection of this manual)When using Focus in an automobile, boat, or on other DC sources with the DC power supply, make sure that the vehicleis started and running before connecting the Focus unit. Ifthe DC power supply does not illuminate and requires resetting,disconnect the DC power supply from the DC outlet, restart yourvehicle, and then reconnect your DC power supply intothe DC outlet. Failure to follow these instructions canresult in the power supply not supplying power to Focus.MN170-1 rev A 03/116When the automobile in which you areusing the Focus unit is turned off, disconnect and remove the unit from theautomobile with you. Do not store Focus in a very hotautomobile or in other similar, high-or low-temperatureenvironments. Operating or storing the unit outside the normal temperature range can affect the performance of theFocus. (Refer to the Specificationssection in this manual.)If the Focus has been stored for an extended period of timeoutside its normal operating temperature range, the unitshould be allowed to return to normal operating temperature before being turned on. (Refer to the Specificationssection in this manual.)Storing your Focus battery for extended periods of time athigh temperatures or with a fully charged/completelydischarged battery can degrade its overall battery life.Depending upon the temperature of the Focus battery, it cantake several minutes for the charging cycle to start afterconnecting to power. This is a normal condition and is intended for safe charging.The Focus battery does not need to be fully discharged before recharging. It is recommended to charge the Focusbattery after each use.If the Focus power supply remains connected when the batteryis fully charged, the four LEDs will turn off within 1⁄2hour.Cannula tubing must be non-kinking, which can be used for a total length of up to 25 ft (7.6 m) maximum.NO SMOKING signs should be prominently displayed in the homeor wherever Focus is in use. Proper information aboutthe dangers of smoking in the presenceof medical oxygen should be relayed.MN170-1 rev A 03/117Important Safety Rules for Optional AirBeltThe incorrect use of AirBelt can cause the battery to get hot,ignite, and can cause serious injury. Be sure not to pierce,strike, step on, or drop the battery, or otherwisesubject the battery to strong impacts or shocks.Do not attempt to charge the optional AirBelt withthe Focus power supply or AirBelt can be damaged.Use only the AirBelt power supply provided to charge AirBelt.Do not allow Focus or AirBelt to be stored in a very hotautomobile or in other similar, high- or low-temperatureenvironments. Operating AirBeltoutside the normal temperaturerange can affect the performance.(Refer to the Specifications section in this manual.)Storing your AirBelt for extended periods of time at high temperatures or with a fully charged or completely dischargedbattery can degrade its overall battery life.Depending upon the temperature of the Focus battery, it cantake several minutes for the charging cycle to start afterconnecting to power. This is a normal condition and is intended for safe charging,AirBelt does not need to be fully discharged before recharging. It is recommended to charge AirBelt after each use.If the AirBelt power supply remains connected when AirBelt isfully charged, the four LEDswill turn off within 1⁄2 hour.Replace safety cap on AirBelt cord when not in use.MN170-1 rev A 03/1187658[Read the Important Safety Rules section before operating this equipment.]Getting Started with Your FocusPortable Oxygen ConcentratorThe Focus packaging contains the following items, as shown below. If any items are missing, contact your Equipment Provider.1)Focus unit with carrying bag.2)Coil Cord w/Switch, connects battery to Focus3)Battery Pack, Lithium Ion/Rechargable (2 supplied)4)Battery case5)Universal Power Supply (AC/DC)6)AC Power Cord7)DC Power Cord8)Coil Cord without switch, connects battery to power supply only9)Focus Belt10)Focus shoulder strap11)Patient Manual (not shown)Figure 1: Focus with Battery2431Figure 2: Focus PowerSupply with DC Input Cordand adapter9Figure 4: Focus shoulder10Figure 3: Focus beltMN170-1 rev A 03/119Before operating Focus for the first time, familiarize yourself with the major components. These are illustrated in the Figuresonthe following pages and discussed later in the manual.Connecting to the Focus Power Inlet:Locate the arrow marking at the top of theconnector. Insert connector (Figure 5) intothe Focus power inlet (Figure 6) with thearrow on the side of the connector facing outward. Do not force the connector into the power inlet, as it can be inserted onlyoneway. This ensures that neither the unit nor the power accessories are damaged.Focus operates fromfourdifferent power sources.NOTE: Alwaysconnect to the Focus power inlet first before connecting to a power supply.1)Connecting Focus to AC electrical power:When you are near an AC outlet,you may choose to operate Focus with the universal power supply rather than the battery.Connect the cord on the power supply labeled asDC OUT To Focus into the Focus unit’s power inlet,as shown in Figure 7. Do not force the plug, as it should beinserted only one way.From the other end of the power supply, connect the 3-prong AC cord from thepower supply into any standard outlet.Focus unit’spower inletFigure: 6Focus unit’spower connectorFigure: 5Figure: 7DC OUT to FocusFocus unit’spower inletMN170-1 rev A 03/11102) Connecting Focus to a DC power source:The universal power supplycan also be used to operate the Focusunit from any 12-Volt DC power source.For example: to an automobile, (boat, motor home, etc.) with a12-Volt DC outlet.Connect the power supply cord labeled DC OUT To Focus into the Focus unit’s power inlet, as shown in Figure 8.Place the DC accessory adapter onthe end of the DC power cord.Connect the other end into the power supply input connection labeled Accessory DC IN.You can then connect the DC power cord (withadapter attached) into the12-Volt DC power source.Do not force the cords, asthey can be inserted only one way.Connect to FocusAccessory DC INFigure: 8DC OUT to FocusDC accessory adapterDC power cordMN170-1 rev A 03/11113)Connecting Focus with the Battery, as shown:Before using the battery, check that it has a sufficient charge.The battery is equipped with a gauge (Figure 9) to indicate the level of battery charge(25-100%). To check the level ofcharge of the battery, press thebutton on the battery’s keypad. The battery gauge/indicator(s)LEDs to the left of thebutton illuminate to indicate thelevel of battery charge (25-100%).Connect the switch end of the battery cord into the Focus unit’s powerinlet only, as shown in Figures 5 and 6.Connect the other end into the battery. Do not force the cords, as they can be properly inserted only one way.Refer to the instructions on charging the battery in the Battery Charging section.Focus is very light weight and easy to wear using the AirSep-supplied shoulder strap (Figure 4), or belt (Figure 3). You may clipthe battery on to either the strap or belt.Focus can be worn on the waist by feeding the AirSep-suppliedwaist belt (Figure 10) or theoptional AirBelt, (Figure 11)through the loops on the back ofthe Focus unit’s carrying bag. Focus can also be worn over theshoulder with the use of theAirSep-supplied shoulder strap as shown (Figure 12).Figure 10: Focus unit worn on the waist Figure 11: Focus unit worn with AirBelt Figure 12: Focus unit worn with the shoulder strapFocus units Power InletBattery GaugeBelt / Shoulder Figure: 9Strap clipMN170-1 rev A 03/1112Battery ChargingCheck to make sure your unit’s battery is fully charged beforeventuring out with Focus forthe first time or upon subsequentuse. To check the level of charge of the battery, press the button on the battery’s keypad. The battery gauge/indicator(s)illuminate to indicate the levelof battery charge (25-100%).To charge the Focus battery while using Focus:1a) Using AC Power: Follow the instructions in the Connecting Focus to AC electrical power section.1b) Using DC Power: Follow the instructionsin the Connecting Focus with the Batterysection.2)Connect the coiled battery cord (no on/off switch)into the power supply outlet labeled DC OUT ToBattery. Connect theother end to the battery.Note: The battery is charging whenever the unit operateson AC or DC power.The Focus battery will completely rechargefrom its fully depleted state in approximately 4 hours, whether the unit is in useon AC or on DC power.While charging a fully discharged battery, the LED will continueto blink until 25% capacity is reached. The LED will thenturn solid.Each of the four LEDs, 25% -100%, will blink as stated above, then turn solidwhen the battery reaches it’s capacity.When all LEDs illuminate solid, the battery is fully charged and the LEDs will remain solid for a period of time, then allfour LEDs will turn off.Figure: 13CD032-2Cord for recharging only(no on/off switch)DC OUT To Battery DC OUT to FocusMN170-1 rev A 03/1113Optional AirBeltOptionally, you may also havean AirBelt for extended use of Focus.The optional AirBelt (Figure 14),can power the Focus unit for up to 4 hours.Before using AirBelt, check that it is sufficiently charged.It requires approximately 3 1⁄2 hours to completely charge.AirBelt is equipped with a battery gauge/indicator to indicate thelevel of battery charge (25-100%). To check the levelofcharge, press the button on the AirBelt keypad. The battery gauge/indicator(s) illuminate to indicate the level of batterycharge (25-100%). Connect the interface cable (Figure 15) intothe AirBelt, then plug the other end of the interface cableinto the Focus, as shown in Figure 16. For proper orientation of the connector, see Connecting to the Focus Power Inletsection.Figure 14:AirBelt batteryAirBelt batterycharge level(25-100%Figure 15:AirBelt to Focus cordFigure 16:AirBelt batterywith FocusAirBelt toFocusconnectionMN170-1 rev A 03/1114Charging the Optional AirBeltTo chargethe AirBelt battery for extended use:1)Release safety cap from end of the AirBelt cord.2)Connect the AC/DC power supply (includedwith AirBelt Accessory kit) to theend of AirBelt’s power cord, as shownin Figure 17.3)Connect the AirBelt power supply to anAC electrical outlet to recharge.Replace safety cap on AirBelt cord when not in use.Do not attempt to charge the optional AirBelt with the Focus power supply or the AirBelt can be damaged.Use only the AirBelt power supply provided to charge AirBelt.The Focus AirBelt will completely recharge from itsfully depleted state in approximately 3 1⁄2 hours.While charging a fully discharged battery, the LED will continueto blink until 25% capacity isreached. The LED will then turnsolid.Each of the four LEDs, 25% -100%, will blink as stated above, then turn solid whenthe battery reaches it’s capacity.When all LEDs illuminate solid, the battery is fully charged andthe LEDs will remain solid for a period of time, then all fourLEDs willturn off.Figure 17: AirBelt Battery Charging set-upAirBeltAC/DC Power SupplyConnecting the AirBelt cord to the power supply cordMN170-1 rev A 03/1115The incorrect use of AirBelt can cause it to get hot, ignite,and may cause serious injury. Be sure not to pierce, strike,step on, or drop the battery, or otherwise subject the battery to strong impacts or shocks.Do not store Focus or AirBelt in a very hot automobile orin other similar, high- orlow-temperature environments.Operating or storing the AirBelt outside the normal temperaturerange can affect its performance. (Refer to theSpecifications section in this manual.)Storing your AirBelt for extended periods of time at high temperatures or with a fully charged or completely dischargedbattery can degrade its overall battery life.Depending upon the temperature of the Focus battery, it cantake several minutes for the charging cycle to start afterconnecting to power. This is a normal condition and is intended for safe charging.AirBelt does not need to be fully discharged before recharging. It is recommended to charge it after each use.If the AirBelt power supply remains connected when it is fully charged, the four LEDs will turn off within 1⁄2 hour.MN170-1 rev A 03/1116[Read the Important Safety Rules section before operating this equipment]Nasal CannulaA nasal cannula with tubing are used to deliver oxygen from the Focus unit to the user. The tubing is connected to the unit’soxygen outlet (See Figure 18).AirSep recommends a nasal cannula with 7 ft(2.1 m) of tubing, AirSep Part No.CU002-1, or other suitable cannula. Otherlengths of non-kinking/starchannel cannula can be used for a total length of up to 25 ft (7.6 m) maximum.When Focus is operating but does not sense breathing for 15minutes, a constant alarm sounds, and the amber alarm lightilluminates simultaneously. If this occurs, check the connection from the cannula to the Focus unit, make sure that the nasalcannula is positioned properly on your face, and ensure that you are breathing through your nose. (Your physician mayrecommend the use of a chin strap if needed.) If the alarm condition continues, change to another source of oxygen as available,and contact your Equipment Provider.Always followthe cannula manufacturer’s instructions for proper use. Consult your licensed health care provider todetermine how often the cannula should be replaced.Ensure the cannula is fully inserted and secure. This ensuresthat the Focus unit can properly detect inspiration foroxygen delivery.Figure: 18Connect the Cannula toFocus’s Oxygen OutletFocus Power InletMN170-1 rev A 03/1117Focus Unit ComponentsNow that you are familiar with Focus’s components, review the instructions on the following pages to operate the Focus unit.Cannula tubing must be non-kinking, which can be used for a total length of up to 25 ft (7.6 m) maximum.Figure 20: Focus Exterior View - FrontFocus Power InletAir OutletAir InletFocus Control Panel (Top view): Alarm Display and Power InletAlarm IndicatorBi-color LEDGreen light: On/ Pulse Flow IndicatorAmber light: Alarm and Service IndicatorLabel/PatientInstructionsFigure 21: Focus Exterior View - BackFigure: 19MN170-1 rev A 03/1118[Read the Important Safety Rules section before operating this equipment]Operating Instructions1.Locate and position Focus so that the air inlet and outletare not obstructed.2.Power the unit from (a) the battery; (b) DC outlet (i.e. automobile or motor boat); or (c) an AC outlet (i.e. normalhousehold electric). (Refer tothe Power Supplies sectionof this Patient Manual.(Refer toConnecting to Focus’s Power Inletsectionfor specific instructions on the connection of power sources.)3.Securely connect your cannula to theoxygen outlet, as shown in Figure 18.Use no oil, grease, or petroleum-basedor other flammable products on the oxygen carrying accessories or the Focusunit. Oxygen accelerates the combustion of flammable substances.4.Lift the control panel tab on the unit’s power inlet and connect the selectedpower source. (i.e., battery, AC or DC powersupply, or optional AirBelt)5.Turn the Focus unit on by pressing the power switch to the on position (l). The LEDs on the control panel willilluminate, alternating betweengreen and red, momentarily. Also, each time you turn on Focus, a brief alarm sounds.This indicates that Focus is powered for use.When Focus senses inhalation, oxygen is supplied to you through your cannula.The time required to reach maximum oxygenconcentration after turning on the Focus unit is approximately two minutes.6.To turn Focus off, press the power switch to the off position (0).MN170-1 rev A 03/1119[Read the Important Safety Rules section before operating this equipment]Power Supplies (Overview)Focus can be powered in four differentways – the battery, AC power, DC power,or an optional AirBelt. The Focus powersupply functions both as an AC power supply and a DC power supply.(Refer toConnecting to Focus’s Power Inletsection forspecific instructions regarding the connection of optionalpower sources.)Battery:Two rechargeable batteries are supplied with Focus.Each battery, when fully charged, supplies power to theFocus unit for up to 1 1⁄2hours. An audible alarm sounds when the battery power is getting low. The alarm is discussed inthe Audible Alarm and Indicator Lightssection of this manual. The 25% capacity LED will blink every 1⁄2 second toindicate a low state of chargewhen the button is pressed.During this condition, change to another battery or alternate power source.Battery Charging (Battery Charging section):To charge the battery, connect the battery to either the power supply anda 100-240 volt, 50/60 Hz AC power outlet, or connect the power supply to a DC power outlet in an automobile (boat,motor home, etc.). A discharged battery requires approximately four hours to fully charge. It is recommended torecharge the battery, even if only partially depleted, as often as possible.Universal Power SupplyThe AC power supply side of the universal power supply, allows the Focus unit to connect to a 100-240 volt, 50/60 Hzoutlet. The power supply converts 100-240volt AC to a DC voltage for the Focus unit to operate while recharging theFocus battery simultaneously.The DC power inlet on the universal power supply, allows the Focus unit to connect to a motor vehicle’s 12-Volt DCoutlet for the Focus unit to operate while recharging Focus’s battery simultaneously.Optional AirBelt:Focus can also be powered withAirBelt. AirBelt can be worn around the waist. When fully charged,the battery supplies power to Focus for up to 3 1⁄2 hours. AirBelt connects to theFocus unit’s power inlet. It can berecharged by connecting it only tothe AirBelt AC power supply.MN170-1 rev A 03/1120[Read the Important Safety Rules section before operating this equipment]Audible Alarm and Indicator LightsWhen the Focus unit senses inhalation, apulse of oxygen is deliveredthrough the nasal cannula. The green light on the unit’scontrol panel blinks each time a breath is detected.Additionally, when the unit is operating and the battery is simultaneously beingcharged through the AC or DC power supply,the battery for the Focus unit will display the charge level of the battery (25%to 100% state of charge) on the batterygauge/indicator(s) and remain on for approximately one hour after reaching a full charge.An audible alarm sounds if Focus has a low battery, if the cannula is disconnected, or if performance of the unit is outside ofspecifications. The light and audible alarm conditions are explained in detail below and summarized on the chart later in thissection of the manual.Start-UpA brief alarm sounds and the green and redLEDs (lights) will alternate at start-up. Focus begins to operate when thealternating LEDs (light) stop andgreen LED (lights) remains on.Low BatteryFocus unit indicators:As the battery power approaches a low level,the amber light on the Focus unit will flash on for1⁄2 second with a 5-second pause and simultaneously, a 1⁄2 second alarm soundswith a 5-second pause. Following thebattery warning indicators, if action is not taken, the unit will shut down. This will be indicated when the amber lightflashes 2 times with a 5-second pause and simultaneously,a 1⁄2 second alarm sounds 2 times with a 5 second pause.Battery indicator:The green light indicator on the battery gauge(Figure 9) light illuminates intermittently.When either of these conditions occurs,connect Focus to a DC poweroutlet or to an AC poweroutlet, or change toanother source of oxygen within two minutes. The level of battery charge is indicated by the battery gauge/indicator(s).You can also check the state of charge at any time by pressing the button.As noted above, when the unit is connected to AC or DCpower outlet, you may simultaneously charge the Focus batterysupplied with the unit while using the unit.In the event of an alarm or you observe Focus is not working properly; consult the Troubleshooting section in thismanual. If you cannot resolve the problem, consult your Equipment Provider.MN170-1 rev A 03/1121If you feel discomfort or are experiencing a medicalemergency, seek medical assistance immediately.Cannula disconnectedWhen Focus is operating but does not sense breathing for 15 minutes, a constant alarm sounds, and the amber alarm lightilluminates simultaneously. If this occurs, check the connection from the cannula to the Focus unit, make sure that thenasal cannula is positioned properly on your face, and ensure that you are breathing through your nose. (Your physicianmay recommend the use of a chin strap ifneeded.) If the alarm condition continues, change to another source of oxygen,as available, and contact your Equipment Provider.Focus’s capacity is exceededIf your breathing rate causes the capacity of Focus to be exceeded, an alarm sounds 3 times every 1⁄2 second with a 5second pause, and the amber alarm light illuminates simultaneously. You should reduce any physical activity, reset alarmby turning unit off and back on, and then if necessary changeto another source of oxygen as available, and contact yourEquipment Provider.General malfunctionIf Focus has a general malfunction, an audible alarm sounds and the red alarm lightilluminates. If this alarm conditionoccurs, change to another source of oxygen as available, andcontact your Equipment Provider.Service lightIf the Focus unit’s normally green lightchanges to solid amber with no audible alarm, contact your Equipment Provider.When the service indicator illuminates solid amber, it is time for your Focus unitto be inspected and/or serviced by yourEquipment Provider. After any necessaryservice and the performance is verifiedby the Equipment Provider, the serviceindicator light will be reset.This unit is not to be used for life support. Geriatric, pediatric, or any other patients unable to communicate discomfortwhile using this unit may require additional monitoring. Patients with hearing and/or sight impairment(s) may needassistance with monitoring alarms.Dual displayService Required (amber)Figure 22: Indicator of Required Inspection/ServiceMN170-1 rev A 03/1122How to Respond toFocus’s Audible Alarm and Indicator LightsStatusAudible AlarmLightIndicatesActionIndicatorBrief, continuous atstart–up(Green) and (Red)alternate;then (Green)continuous lightFocus has been turnedon.You may begin to operate your Focusunit.IndicatorNo(Green) flashes;on each breathFocus is delivering oxygenas a pulse flow.Continue using Focus normally.IndicatorNo(Amber) continuouslightInspection and/orServicerequired.Return unit to Equipment Providerfor inspection and/orservice.BatteryIndicatorNo25% (Green) light;flashesBattery charge is low.Connect the Focus unit into a DCoutlet or an AC outlet immediately.Charge battery.AlarmIntermittent:Beep(Amber) alarm;intermittent lightWarning: Battery voltageapproaching too low alevel to continue operatingFocus.Connect the Focus unit into a DCoutlet or an AC outlet immediately.Charge battery.AlarmIntermittent:Beep, beep(Amber) alarm;intermittent lightBattery shutdown: Batteryvoltage is too low tooperate Focus.Connect the Focus unit into a DCoutlet or an AC outlet immediately.Charge battery.AlarmContinuous:Beep(Amber) alarm;continuous lightNo breath detected by theunit for a predeterminedtime period.Check the cannula connection. Ensurethat you are breathing through yournose. If the alarm persists, contactyour Equipment Provider.AlarmIntermittent:Beep, beep, beep(Amber) alarm;intermittent lightBreathing rate isexceeding the capacity ofthe Focus unit.Reduce activity, and then if necessaryuse another source of oxygen, asavailable. Contact your EquipmentProvider.AlarmAudible alarm sounds(Red) lightGeneral malfunction of theFocus unit has occurred.Turn off the unit. Change to anothersource of oxygen, and contact yourEquipment Provider.MN170-1 rev A 03/1123Cleaning, Care, and Proper MaintenanceCabinetDisconnect the power cord from the electrical outlet before you clean or service the unit to prevent accidentalelectrical shock hazard.Do not use liquid directly on the Focus unit to clean it. Alist of undesirable chemical agents includes but is not limitedto the following: alcohol and alcohol-based products, concentrated chlorine-based products (ethylene chloride), andoil-based products (Pine-Sol, Lestoil). These are NOT to beused to clean the plastic housing on Focus, as they candamage the unit’s plastic.Replace the disposable cannula periodically following normal usage according to your Equipment Provider’srecommendations.Keep the Focus unit clean and free from moisture and dust. Cleanthe plastic housing periodically by wiping with a lintfree cloth or with a mild household cleaner applied witha damp cloth or sponge. Pay special attention to the oxygenoutlet for the cannula connection to make sure it remains free of dust, water, and particles.To prevent a voided AirSep warranty, follow all manufacturer’s instructions.AirSep does not recommend the sterilization of this equipment.Carrying Bag, Battery Case, Belt and StrapTo clean the carrying bag, batterycase, belt, and strap, brushonly with warm, soapy water (do not saturate), then allowto air dry. Do not machine wash or dry.MN170-1 rev A 03/1124Focus AccessoriesFor proper performance and safety, use onlythese listed accessories supplied by AirSep through your Equipment Provider. Useof accessories not listed below could adversely affect the performance and/or safetyof the Focus Portable Oxygen Concentrator.Part Number / DescriptionMI332-1Focus Bag Set includes the following:includes: MI333-1 Battery Case, FocusMI334-1 Shoulder Strap, FocusMI335-1 Belt, FocusMI345-1 Carrying Bag, FocusBT023-1 Lithium Ion battery pack, (2 supplied)CD034-1 DC power cordCD032-1 Battery-to-Focus cord with On/Off SwitchCD032-2 Battery-to-Power Supply cord (only) for charging batteryPW019-1Power Supply with battery charger for AC/DC connections, includingappropriate AC power cordOptional AirBelt includes the following:BT017-1 AirBelt batteryPW009-2Power Supply for AirBelt, including appropriate AC power cordCord for connecting AirBelt to FocusCD035-1 AirBelt-to-Focuscord with On/Off switchReserve Oxygen SupplyYour Equipment Provider may recommend another source of supplemental oxygen therapy in case there is a mechanicalfailure or a power outage.In the event of an alarm or you observe Focus is not working properly, consult the Troubleshooting section in thismanual. If you cannot resolve the problem, consult your Equipment Provider.If you feel discomfort or are experiencing a medicalemergency, seek medical assistance immediately.MN170-1 rev A 03/1125TroubleshootingThe Focus product is designed for years of trouble-free use.If your Focus Portable Oxygen Concentrator fails to operate properly, refer tothe chart on the following pages for possiblecauses and solutions and, if needed, consult your Equipment Provider.Do not attempt any maintenance other than the possible solutions listed below.ProblemProbable CauseSolutionAlarm condition,Intermittent: Beep, beep(Amber) light illuminates simultaneouslyand Focus shuts down.Battery voltage is too low to operate theFocusunit.Connect to DC or an AC outlet immediately.Alarm condition,Intermittent: Beep, beep, beepand the (Amber) alarm light illuminatessimultaneously.Breathing rate has exceeded the capacityof theFocusunit.Reduce activity, and then turn unit off and back onagain to reset unit. If necessary, change to anothersource of oxygen as available and contact yourEquipment Provider.Unit does not start on battery power, although thebattery indicates a charge.Battery may be hot tooor cold if leftoutdoors such as in an automobile.Allow thebattery to reach normal operatingtemperature, which may take several minutes ifexposed to temperature extremes. Temporarilyconnect your AC or DC power supply to the unit’spower inlet and power source, as needed.Delay in recharging battery.Battery exceeds charging temperature.Unit may be operated; however, charging may notresume until battery temperature is reduced.MN170-1 rev A 03/1126ProblemProbable CauseSolutionUnit alarms, does not start in automobile whileconnected to a properlyfunctioning DC outlet.Focus power supply needs resetting.Turn off unit. Disconnect the DC power supply fromthe automobile outlet, restart the automobile, andthen reconnect the DC power supply into theautomobile DC outlet to reset the DC power supply.Alarm condition,Audible alarm soundsand the (Red) alarm light illuminates.A general malfunction has occurred.Turn off unit. Change to another source of oxygen asavailable, and contact your Equipment Provider.Solid (Amber) light without audible alarm.Focus need inspection and / or service.Contact your Equipment Provider. It is time for yourFocus unit to be inspected and / or serviced by yourEquipment Provider. After any necessary service andthe performance is verified by the EquipmentProvider, the alarm service/indicator light will bereset.All other problems.Turn off unit. Change to another source of oxygen asavailable, and contact your Equipment Provider.MN170-1 rev A 03/1127Focus SpecificationsOxygen Concentration:*Pulse setting equivalent to a continuous flow of 90% oxygen - 3% / +5.5%Dimensions:6.4 in. high x 4.8 in. wide x 2.5 in. deep (16.4 cm high x 12.2 cm wide x 6.1 deep)Weight:Concentrator 1.75 lb (0.8 kg)Battery 0.53 lb (0.2 kg)Optional AirBelt Battery 1.8 lb (0.8 kg)Power:Universal Power Supply:AC Power Supply: Input # 1_100 – 240 VAC (1.5 Amps max at 120 VAC 50/60 Hz)DC Power Supply: Input # 2_11-16 VDC 5.0 Amps maxBattery duration(Rechargeablelithium Battery)Battery: 1 1⁄2 hours (per battery)Optional AirBelt Battery: 4 hoursBattery recharge time:4 hours; optional AirBelt: 3 1⁄2 hoursWarm-up time:2 minutesBattery cycle life:Approximately 300 cycles, then 80% capacity or below.Audible alarms and pulsevisual indicators:Start-up – audible and visualPulse flow – visualCannula disconnect- audible and visualBreath rate alarm – audible and visualGeneral malfunction – audible and visualService required - visualLow battery - audible and visualBattery condition – battery level indicator on batteryTemperature range:Normal operating temperature: 41°F to 104°F (5°C to 40°C)Storage temperature: -2°F to 140°F (-20°C to 60°C)* Based on an atmospheric pressureof 14.7 psi (101 kPa) at 70°F (21°C)* Operating unit outside of normal operational temperature range can affect performance.MN170-1 rev A 03/1128ClassificationType of protection against electric shock:Class IIProtection from electric shock is achieved by double insulation.Degree of protection against electric shock:Type BFEquipment providing a particular degree ofprotection against electric shock regarding1) allowable leakage current;2) reliability of protectiveearth connection (if present).Not intended for direct cardiac application.Independent testing for Medical Electrical Equipment Standard:Tested by QPS Testing Services NA Inc. to be in compliance with,IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety2nd edition 1988, A1 1991, A2 1995.Tested by QPS to be in compliance with applicable requirements of the Standard,CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment – Part 1: GeneralRequirements for Safety, General instruction No. 1; Supplement No. 1; 1994Amendment 2 – 1998 and General instruction No. 2 November 2003Protection against potential electromagnetic or otherinterference between the equipment and other devices.Tested by Ultratech Group of Labs to be in compliance with:EN 60601-1-2:2007 (EMC) (2nd Edition), Medical ElectricalEquipment, Part 1: General Requirements for SafetyCollateral Standard: Electrical Compatibility - Requirements and TestsRTCA-DO160F Airborne Equipment, Sec. 21,Emission of Radio Frequency EnergyCISPR 11:2004 / EN 55011:1998 +A1:1998 & A2:2002, ClassB Group 1, “Industrial, Scientific, and Medical (ISM)Equipment”FCC Part 15, Subpart B – Class B Unintentional RadiatorsMethod of cleaning and infection control allowed:Please refer to “Cleaning, Care, and Proper Maintenance” section of this Focus Patient Manual.Degree of safety of application in the presence of flammable anesthetic gases:Equipment not suited for such application.Mode of operation:Continuous duty.MN170-1 rev A 03/1129Limited WarrantyAirSep Corporation warrants the Focus Portable Oxygen Concentrator tobe free from defect inparts for three years (asspecified on the original invoice provided) from the date of delivery to the original purchaser, under normal use and operation.The batteries are warranted for one year. AirSep Corporation’sobligations under this warrantyare limited to the repair orreplacement of any such item of equipment (or part thereof) shown to be defective or, at AirSep Corporation’s option, to refundthe purchase price of any such defective item of equipment.Each item of equipment for which a warrantyclaim is asserted shall, at the requestof AirSep Corporation, be returned on aprepaid basis with proof of purchase date to the AirSep factory at the expense of the purchaser. The purchaser will beresponsible for return freight charges. Replacement parts shallbe warranted as stated abovefor the unexpired portion of theoriginal three-year parts warranty (as specified on the originalinvoice provided). This warranty does not extend to any item orpart subjected to misuse, accident, improper maintenance, or application, or which has been repaired or altered outside of theAirSep Corporation factory withoutthe express prior written authorization of AirSep Corporation.THE FOREGOING WARRANTY IS IN LIEU OF ANY OTHERWARRANTY, EXPRESSED OR IMPLIED, IN FACT ORIN LAW, INCLUDING WITHOUT LIMITATION THE WARRANTY OF MERCHANTABILITY OR THE WARRANTYOF FITNESS FOR PARTICULAR PURPOSE. IT ISEXPRESSLY UNDERSTOOD THAT PURCHASER’S SOLE ANDEXCLUSIVE REMEDY FOR DEFECT IN PARTS IS LIMITED TO ENFORCEMENT OFAIRSEP CORPORATION’SOBLIGATION AS SET FORTH ABOVE, AND AIRSEP CORPORATION SHALL NOT BE LIABLE TO PURCHASER OROTHERS FOR LOSS OF USE OF THE EQUIPMENT ORFOR OTHER SPECIAL, INDIRECT, INCIDENTAL, ORCONSEQUENTIAL DAMAGES.MN170-1 rev A 03/1130For European representative:Gavin Ayling9 Bungham LanePenkridge StaffordStaffordshire ST19 5NH EnglandE-mail:eurorepcontact@airsep.comMN170-1 rev A 03/1131For service on your Focus PortableOxygen Concentrator, please contact your local Equipment Provider at:Manufactured by:AirSep CorporationBuffalo, NY 14228-2085 USA**|MN170-1_A4~**MN170-1 Rev A