Eclipse 3 With AutoSAT - Chart Industries

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Eclipse 3 with autoSAT Personal Ambulatory Oxygen System (PAOS) Model 1000BPROVIDER TECHNICAL MANUAL

TABLE OF CONTENTSGeneral Information.4Warning and Caution Statements. 4Introduction to the Eclipse 3 Oxygen System. 5Eclipse Oxygen System Specifications.6Pulse Dose Mode Specifications. 7Power Accessory Specifications. 7AC Power Supply. 7DC Power Supply. 7Power Cartridge (Battery). 7Independent Safety Testing. 8Provider Support Policy. 8Electromagnetic Compatibility. 9Guidance and Manufacturer’s Declarations. 9How The Eclipse 3 Works.13Introduction.13ATF Concentrator Module.13Compressor and Compressor Enclosure.14Power Distribution.14Control Board.14Control Panel.15User Controls & System Status Indicators.15Continuous Flow Mode.17Pulse Dose Mode.17Provider Mode Functions.18Alarm Code.18Pulse Mode Sensitivity Adjustment.18Hours of Operation.189V Battery Status.18Rise Time.18Software Version.18Service Mode Functions.19EDAT.19Power Supplies.20AC Power Supply.20DC Power Supply.20Power Cartridge.21Typical New Power Cartridge Operation Time.21Charging Algorithm.24Training The Patient.25Introduction.25Pre-Delivery Check List.25Indications for Use.26Contraindications.26Basic Concept Training.26Safety Guidelines and Operational SafetyWarnings/Cautions.26Locating the Eclipse.27The Users Manual.27Showing Panel Buttons, Indicators, Alertsand Alarms.27Showing Power Cartridge Power Level.28Selecting the Proper Flow Mode and Setting.28Selecting Continuous Flow Mode.28Selecting Pulse Dose Mode.28Battery Conservation Feature.29Adjusting the Pulse Mode Sensitivity Setting.29Adjusting Rise Time.30Connecting the AC Power Supply.30Connecting the DC Power Supply.31Active Lifestyle Training.31Attach the Universal Cart.32Using Around the House.29Traveling by Vehicle.29Traveling by Air.34Traveling by Cruise Ship.34Traveling by Train.34Eclipse Maintenance.34Weekly Maintenance—Patient.34Clean the Air Inlet Filter.35Clean and Care for the Tubing and Cannula.35Clean the Cabinet and Control Paneland Power Supplies.35Monthly Maintenance—Patient.36Care for the Power Cartridge.36Calibrating the Power Cartridge.36Patient Training Checklist.37

TABLE OF CONTENTS (continued)Annual Maintenance—Provider.38Introduction.38Annual Maintenance Check List.38Checking and Replacing the Power Cartridge.38Eclipse Monthly Run Cycle.38Annual Maintenance Procedures.39Removing the Unit Cover.39Remove and Replace 9 Volt Battery.43Remove and Replace HEPA Filter.44External Filters (E1, E2, E2 PLus, and Early E3s).44Internal Filters (Newer E3s).45Remove and Replace the CompressorIntake Filter.47Reinstalling or Replacing the Unit Cover.48Test Procedures.49Eclipse Purity and Flow Rate TestProcedure - Preferred Method.49Purity and Flow Rate Test ProcedureAlternate Method.51Assembly and Alarm Verification Tests.51Record Hours of Operation & Software Version.52Electrical Safety Test.53Cleaning the Eclipse.53Provider Service and Maintenance Record.54Shipping and Transporting the Eclipse.55Storing the Eclipse.55Discarding.55Remove and Replace the Product TankAssembly (PN 6138-SEQ) Eclipse 1,Eclipse 2, Early Eclipse 3.68Routing Diagram for Pneumatic Tubing.70Remove and Replace the Product TankAssembly (PN 4378-SEQ) Eclipse 3–2011 inSN 11f06100456 and Above.71Electronics.76Remove and Replace the ControlBoard Assembly.76Remove and Replace the Buzzer Wire Harness.78Control Board Connector Diagram.79Remove and Replace the Power ManagerPrinted Circuit Board.80Power Manager PC Board Connector Diagram.83Power Manager PCB Identification.84Compressor.89Remove and Replace the Compressor Box.89Preventative Maintenance Parts.93Replacement Parts List.93Optional Accessories.94Chart-SeQual Customer Service ContactInformation.95Troubleshooting, Service, andRepair Procedures.56System Troubleshooting and Alarms.57Alarm Conditions and Alarm Codes.60Malfunction Codes.61System Schematics and Diagrams.62Oxygen Circuit.65Remove and Replace the ATF Module.653

Personal Ambulatory Oxygen System Provider Technical ManualGeneral InformationThis technical manual will familiarize you with Provider-specific information regarding the Eclipse 3 Oxygen System.Instructions in this manual are intended to help ensure that:- Providers are familiar with Eclipse 3 system components and system principles of operation- Providers are given proper guidance in the use of the Eclipse 3 and its accessories that can be conveyedto patients- Providers are made aware of the care, diagnostics, maintenance, and repair of the Eclipse 3Warning and Caution StatementsSafety instructions are defined as follows:WARNING:Important safety information for hazards that might cause seriousinjury.CAUTIONImportant information for preventing damage to the Eclipse.NOTE:Places emphasis on an operating characteristic or importantconsideration.4

Personal Ambulatory Oxygen System Provider Technical ManualIntroduction to the Eclipse 3 Oxygen SystemECLIPSE 3AC Power SupplyWITH NEMA POWER CORDPN: 5941-SEQDC Power SupplyUNIVERSAL CartPN: 5942-SEQPower Cartridge(battery)PN: 7082-SEQPN: 5991-SEQControl PanelEDAT Service PortHandle(Not for Patient Use)Air InletFilterExternal PowerReceptacleOxygenOutlet PortFAA Approval IconFAAApprovalIconPower CordRetainerRating Label &Serial NumberLocationCartAttachmentLocationFRONTExhaust VentPowerCartridge(Battery)Power Cartridge LatchBACK5

Eclipse Oxygen System SpecificationsPersonal Ambulatory Oxygen System Provider Technical ManualOxygen ConcentratorDimensions (H x W X D)WeightEclipsePower CartridgeFlow SettingsContinuous Flow(measured in Liters Per Minute LPM)Pulse Dose (measured in mL)Continuous Flow AccuracyOxygen ConcentrationMaximum System PressureOxygen Output PressureOxygen ConcentrationStatus IndicatorNominal Sound Level3.0 LPM Continuous Flow3.0 Pulse Dose ModeOperating EnvironmentTemperatureHumidityStorage EnvironmentTemperatureHumidityAltitudeNominal Power0.5 LPM Continuous flow3 LPM Continuous Flow1.0 Pulse Dose Setting6.0 Pulse Dose SettingBattery ChargingNominal Power Cartridge operating timeContinuous Flow2.0 LPM3.0 LPMPulse Dose (@ 12 BPM)2.06.019.3 x 12.3 x 7.1 inches(49.0cm x 31.2cm x 18.0cm)15.0 pounds3.4 pounds0.5 to 3.0 LPM (0.5 liter increments)16-96 (16mL increments), 128mL, 160mL, 192mL /- 10% or 200ml/min, whichever is greater87–95.6% for all flow settings15 psig (103.5 kPa)5.0 psig (34.5 kPa) nominalGreen Light Normal OperationYellow Light Warning or Caution, less than 85% 3%Red Light Flashing Abnormal Operation, less than 70% 5%48 dB(A)40 dB(A)50º F to 104º F ( 10 to 40 C)10% to 95%, Non-condensing, 82.4 F (28 C) Maximum Dew point-4º F to 140º F (-20 to 60 C)Up to 95% Non-condensing0 – 13,123 feet (0 - 4,000 meters)48 Watts145 Watts45 Watts95 Watts50 Watts2.0 hours1.3 hours5.2 hours3.5 hoursNote: Times will decrease with higher bolus size,breath rate, ambient temperature, power cartridgeage and use over time.Continuous Flow IndicationExpressed in liters per minute (LPM)Audible Alarm Indicators Loss of Power/Hot Power Cartridge Low Power Cartridge/Warm Power Cartridge Low Oxygen Output O2 Flow Outside Normal Limits Unit Malfunction Low 9V batteryBack-Up Alarm Power9V Internal BatteryFiltersAir Inlet, HEPA, Compressor IntakeDevice ClassificationIEC Class I, Type B Applied Part, IPX06

Personal Ambulatory Oxygen System Provider Technical ManualPulse Dose Mode SpecificationsPulse Settings1.0 to 6.0, in 16mL increments and 128mL, 160mL, 192mLTrigger SensitivityAdjustable Bolus Rise TimeAdjustable between settings of 1 (most sensitive) to 3 (least sensitive)Adjustable settings of Fast(factory setting), Medium, or Slow Cannula pressure has dropped below the trigger point (typically between 0.15– 0.45cm of H2O of negative pressure) At least 1¼ seconds has passed since the last pulse beganTrigger CriteriaMinimum time betweenbreaths1.25 seconds (max. 3 consecutive breaths)Response to Missing BreathsWhile in Pulse Dose Mode, the Eclipse 3 is always monitoring for breath detection.After 15 seconds of no breath detected, the Eclipse 3 “delivers” Continuous Flow at thelast Continuous Flow setting. After another 15 seconds, the Eclipse 3 stops deliveringContinuous Flow and waits 15 seconds for a breath. The Eclipse 3 will stay in thismodality until a breath is detected. (See Power Cartridge Conservation Feature, page 26.)Bolus Size( 15%) mL1.02.03.04.05.06.0-163248648096128160192Bolus Volume ( /- 15%)Pulse DoseSettingAC Power Supply andPower Cartridge (Battery)DC Power SupplyMax BreathRateMax : Bolus volume decreases as breath rate exceeds published range.Power Accessory SpecificationsAC Power SupplyDC Power SupplyInput Voltage100-240VAC, 50-60 HzInput Voltage11.5-18VDCInput Power245-260 VAOutput Voltage26 VDCOutput Voltage28 VDCOutput Power150W MaxOutput Power200WPower Cartridge (Battery)Output voltageCapacity14.8 VDCQuantity (2) 97.5 W-hrs batteries(Each containing 7.92 grams equivalent Lithium content)Nominal Power Cartridge Life80% Capacity after 500 Charge/Discharge cyclesPower Cartridge Recharge Time1.8 to 5.0 hours, dependent on flow setting, to achieve 80% capacityfrom a fully discharged Power Cartridge7

Personal Ambulatory Oxygen System Provider Technical ManualIndependent Safety TestingEclipse System and Eclipse Concentrator, Model 1000BSafetyIEC 60601-1 :1988 A1 :1991 A2 :1995 Corrigendum (6/95)EN 60601-1(1990) A1(1993) A2(1995) A12(1993) A13(1996) Corrigenda (7/94)ElectromagneticCompatibilityFCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-3-2, EN61000-3-3, IEC61000-4-2,IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, IEC 60601-12 :2001, RTCA DO 160 Rev EAC Power Supply, Model 5941SafetyIEC 60601-1:1988 A1:1991 A2:1995ElectromagneticCompatibilityFCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-3-2, EN61000-3-3, IEC61000-4-2,IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, EN55014-1DC Power Supply, Model 5942Portions of IEC 60601-1:1988 A1:1991 A2:1995SafetyElectromagneticCompatibilityFCC 15B (Sec. 109), EN55011, EN60601-1-2 :2001, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4,IEC61000-4-6, IEC 60601-1-2 :2001Power Cartridge 2400, PN 7082SafetyIEC 62133, UL60950-1, First Edition (UL File MH29443), IEC 60601-1:1988 A1:1991 A2:1995, UNTransportation Tests T1-T8ElectromagneticCompatibilityEN 61000-6-3 :2001 (EN55022 :1998 A1 :2001 A2 :2003), EN61000-6-1 :2001, EN61000-42 :1995 A1 :1998, EN61000-4-3 :2002Any CSA-CUS mark for the Eclipse system does not encompass operation with the DC Power Supply Model 5942.Provider Support PolicyObjective: As a manufacturer our organizational goal is to provide customer support and assistance tothe highest level of excellence.Customers are Providers (which include Dealers, Distributors and Agents).Support includes, but is not limited to, troubleshooting and Return Material Authorizations (RMA).Business Hours are Monday – Friday, 8:00am – 6:00pm EST.Chart-SeQual can only support customers who are recognized as Providers, Dealers, Distributors and/or Agents.These partnerships are qualified as having an existing account or are in the process of credit applicationcompletion. All patient or end-user inquiries including but not limited to RMA, warranty or serial numberquestions must be handled by their Provider.Provider Support Policy: Chart-SeQual Technologies is unable to provide direct assistance, clinical advice or recommendations to a patient or end-user. Providers have sole responsibility in assisting their patients.8

Personal Ambulatory Oxygen System Provider Technical ManualElectromagnetic CompatibilityThis equipment has been tested and found to comply with the limits for medical devices to the IEC60601-1-2 ElectromagneticCompatibility standard. These limits are designed to provide reasonable protection against harmful interference in a typicalmedical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed according to theinstructions, may cause harmful interference to other devices in the vicinity. There is, however no guarantee that interference willnot occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determinedby turning the equipment off and on, the User is encouraged to try to correct the interference by one or more of the followingmeasures: Reorient or relocate the receiving device. Increase the separation distance between the equipment. Connect the equipment into an outlet on a circuit different from that which the other device(s) are connected. Consult with Chart SeQual’s Technical Support Department for help.Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service accordingto the EMC information provided in this manual.Portable and mobile RF communications equipment can affect Medical Electrical Equipment.The use of Accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold bythe Manufacturer of this device as replacement parts for internal components, may result in increased Emissions or decreasedImmunity of the Eclipse 3.The Eclipse 3 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, theEclipse 3 should be observed to verify normal operation in the configuration in which it will be used.Guidance and Manufacturer’s Declaration - electromagnetic emissionsThe Eclipse 3 is intended for use in the electromagnetic environment specified below. The customer or the user of theEclipse 3 should assure that it is used in

Personal Ambulatory Oxygen System Provider Technical Manual 6 Oxygen Concentrator Dimensions (H x W X D) 19.3 x 12.3 x 7.1 inches (49.0cm x 31.2cm x 18.0cm) Weight Eclipse Power Cartridge

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