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Focus PortableOxygen ConcentratorService ManualTMMN171-1 REV C

Expedited Product Warranty Check service is available at 800-482-2473MN171-1 REV C

Table of ContentsSection 1.0Introduction1.11.21.31.41.5Equipment Provider ResponsibilityImportant Notice and Symbol ExplanationsDefinitions of SymbolsFocus SpecificationsFocus ClassificationsSection 2.0Operation Check andTest of Oxygen Concentration2.12.2Description of OperationOperation CheckSection 3.0Operating Instructions3.1General Instructions3.1.1 Connecting to Focus’s Power Inlet3.1.2 Power Sources Available to Focus3.1.3 Nasal Cannula3.1.4 Battery Charging3.1.4.1 Charging Focus Battery While Using the Power Supply withFocus3.1.4.2 Charging the Optional AirBelt Section 4.0Alarm SystemTable #1 - Alarm / Priority4.1Start-up4.2Battery StatusMN171-1 REV C

4.34.4Low BatteryDischarged Battery4.54.6Cannula DisconnectPerformance Warning4.6.1 Focus Capacity Exceeded4.6.2 General MalfunctionSection 5.0Oxygen Concentration Test and SpecificationSection 6.0Routine Maintenance / Instructions to Patient6.1Alarm / Service IndicatorSection 7.0Equipment Provider Maintenance7.17.27.37.47.5Equipment Provider Routine MaintenanceCompressor ServicingRecord MaintenanceInfection ControlCleaning and Preparing for New Patient UseSection 8.0ServiceNote: At this, all repairs must be performed at AirSep’s Service Department. If yourFocus requires service, contact your Customer Service representative to obtain an RGAand instructions for return to AirSep.Section 9.0Troubleshooting9.1MN171-1 REV CTroubleshooting Chart

1.0 Introduction1.1Equipment Provider ResponsibilityAll Equipment Providers of the Focus Portable Oxygen Concentratormust assume responsibilities for handling, operational check-out, patientinstruction, and maintenance. These responsibilities are outlined belowand throughout this manual.This unit is not to be used for life support. Geriatric, pediatric, or any other patients unable tocommunicate discomfort while using this unit may require additional monitoring. Patients withhearing and/or sight impairment(s) may need assistance with monitoring alarms.As an Equipment Provider, you must do all of the following:MN171-1 REV C Inspect the condition of each Focus unit immediately upondelivery to your business location. Note any sign of damage,external or internal, on the delivery receipt, and report itdirectly to both the freight company and AirSep Corporationimmediately. Check the operation of each Focus unit before delivery to apatient. Always operate the unit for a minimum of 10 minutes,and check that the oxygen concentration level is withinspecifications, as described in Section 5 of this manual. Deliver Focus units only to patients authorized by a physician’sprescription. Focus must not be used as a life-supportingdevice. Instruct patients how to use Focus in conjunction with thePatient Manual. Instruct patients to notify their physicians and/or EquipmentProviders if they experience any signs of discomfort. Be available to service each patient at any time. Maintain Focus in accordance with Section 7. Repair components and replace parts only as outlined in thismanual. Use only AirSep parts for replacement in Focus OxygenConcentrators.

1.2Important Notice and Symbol ExplanationsAs you review both the Focus Patient Manual and this Focus Service Manual,pay special attention to the WARNING, CAUTION, and NOTE messages. Theyidentify safety guidelines or other important information as follows:Warning – Describes a hazard or unsafepractice that if not avoided can result insevere bodily injury, death or propertydamageCaution – Describes a hazard or unsafepractice that if not avoided can result inminor bodily injury or property damageNote – Provides information importantenough to emphasize or repeatNO SMOKING signs should be prominently displayed in the home or wherever Focus is in use. Properinformation about the dangers of smoking in the presence of medical oxygen should be relayed.MN171-1 REV C

1.3Definitions of SymbolsSymbols are frequently used on equipment and/or the manual in preference to words with the intention ofdecreasing the possibility of misunderstanding caused by language differences. Symbols can also permit easiercomprehension of a concept within a restricted space.The following table is a list of symbols and definitions used with the Focus Portable Oxygen Concentrator.SymbolDescriptionON (power switch on)SymbolDescriptionOFF (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 unsafeSafety agency for CAN/CSA C22.2 No.601.1 M90 for medical electricalequipmentpractice that if not avoided can result inminor bodily injury or property damageNote – Provides information importantenough to emphasize or repeatKeep unit and accessories dryConsult the accompanyingdocumentsProper disposal of waste of electrical andelectronic equipment requiredUse no oil or greaseNo smokingConsult instructions for useType BF equipmentDo not expose to open flamesOxygen outlet connection to thecannulaDo not block fanCaution: Federal law (USA) restrictsthis for sale or rental by or on the orderof a physician or licensed health careprovider.MN171-1 REV CDo not disassemble

1.4 Focus SpecificationsOxygen Concentration:*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 ½ hours (per battery)Optional AirBelt Battery: 4 hoursBattery recharge time:4 hours; optional AirBelt: 3 ½ 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 batteryNormal operating temperature: 41 F to 104 F (5 C to 40 C)Storage temperature:-2 F to 140 F (-20 C to 60 C)Temperature range:* Based on an atmospheric pressure of 14.7 psi (101 kPa) at 70 F (21 C)* Operating unit outside of normal operational temperature range can affect performance.MN171-1 REV C

1.5 Focus ClassificationsType 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 of protection against electric shock regarding1) allowable leakage current;2) reliability of protective earth 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 other interference 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 Electrical Equipment, Part 1: GeneralRequirements for Safety-Collateral Standard: Electrical Compatibility - Requirements and TestsRTCA-DO160F Airborne Equipment, Sec. 21, Emission of Radio Frequency EnergyCISPR 11:2009 A1:2010 / EN 55011:2009, Class B 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 PatientManual.Degree of safety of application in the presence of flammable anesthetic gases:Equipment not suited for such application.Mode of operation:Continuous duty.MN171-1 REV C

2.0Operation Check and Test of Oxygen Concentration2.1 Description of OperationAir enters the Focus Oxygen Concentrator through an external air intake.This air enters the compressor via a suction resonator that quiets the compressor’s suction sound.The pressurized air then exits the compressor to a two-way solenoid feed valve that directs the air intoone of two sieve beds that contain molecular sieve. The unique property of molecular sieve enables it tophysically attract (adsorb) nitrogen when air passes through this material, thereby separating thenitrogen from the oxygen in ambient air.There are two sieve beds: While one produces high-concentration oxygen, the other is purged of thenitrogen it adsorbed (collected) while it made oxygen. Oxygen exits the product tank after first passingthrough the integrated product filter.In addition to the molecular sieve beds that allow oxygen to be separated from air, Focus contains anOxygen Conserving Device (OCD) valve that controls delivery of high-concentration oxygen to thepatient at the point in the breathing cycle when the patient starts to inhale.Focus delivers a gas consisting of 90% ( 5.5%/-3%) oxygen at a pulse flow rate equivalent to 2 LPM(liters per minute) constant flow.2.2Operation CheckAirSep tests every Focus Oxygen Concentrator thoroughly after manufacture. You must perform thefollowing test to ensure that no damage occurred in shipping or handling.1. Open and inspect all cartons upon delivery. Unpack the unit and removeit from the carton. Inspect the unit itself for damage.If the exterior of a unit’s carton is damaged, or if the unit itself is damaged,note this on the freight bill signed by the driver.2. Connect the power supply or battery to the unit. Turn the Focus unit on by pressing thepower switch to the on position (l). Refer to Section 3 for operating instructions.3. Check to see that the following sequence occurs:a. When Focus is turned on, [A one-second, audible alarm sounds to indicate start-up. Thegreen and red LED’s on the control panel will alternate on/off for (10) seconds. After the(10) second start up is complete the green LED will be illuminated indicating that theFocus is ready to be used.]b. The compressor runs.c. Exhaust air flows from the unit.4.MN171-1 REV CPerform an oxygen concentration test, as described in Section 5.