Transcription
Eclipse 5 with autoSAT Oxygen ConcentratorTECHNICAL SERVICE MANUAL
TABLE OF CONTENTSGeneral Information . 4Warning and Caution Statements . 4Introduction to the Eclipse 5 Oxygen System . 6Power Cartridge . 19Typical New Power Cartridge Operation Time. 20Charging Algorithm. 22Eclipse 5 Oxygen System Specifications . 7Pulse Dose Mode Specifications . 8Power Accessory Specifications . 8AC Power Supply . 8DC Power Supply. 8Power Cartridge (Battery) . 8Independent Safety Testing . 9Electromagnetic Compatibility . 10Guidance and Manufacturer’s Declarations . 10Training The Patient .23Introduction . 23Pre-Delivery Check List . 23Indications for Use . 24Contraindications . 24Basic Concept Training . 24Safety Guidelines and Operational SafetyWarnings/Caution. 24Locating the Eclipse 5 for Proper Use andVentilation. 25How The Eclipse 5 Works . 12Introduction . 12ATF Concentrator Module. 12Compressor and Compressor Enclosure . 13Power Distribution . 13Control Board . 13Control Panel . 14User Controls & System Status Indicators . 14Continuous Flow Mode . 15Pulse Dose Mode . 15Provider Mode Functions . 16Alarm Code . 16Pulse Mode Sensitivity Adjustment . 16Hours of Operation . 169V Battery Status . 16Rise Time (Bolus Delivery) . 16Software Version. 16Service Mode Functions . 17Eclipse 5 Data Acquisition Tool (EDAT) . 17Power Supplies . 18AC Power Supply . 18DC Power Supply. 18The Users Manual . 25Showing Panel Buttons, Indicators, Alerts andAlarms . 25Showing Power Cartridge Power Level . 26Selecting the Proper Flow Mode and Setting . 26Selecting Continuous Flow Mode . 26Selecting Pulse Dose Mode . 26“Power Cartridge (Battery) Conservation” Feature. 27Adjusting the Pulse Mode Sensitivity Setting . 27Adjusting Rise Time . 28Connecting the AC Power Supply . 28Connecting the DC Power Supply . 29Active Lifestyle Training. 29Attach the Universal Cart . 30Using Around the House . 30Traveling by Vehicle . 30Traveling by Air . 32Traveling by Cruise Ship . 32Traveling by Train . 32Eclipse 5 Maintenance . 33Weekly Maintenance—Patient . 33Clean the Air Inlet Filter . 33Clean and Care for the Tubing and Cannula . 33
TABLE OF CONTENTS (CONTINUED)Clean the Cabinet and Control Paneland Power Supplies . 33Monthly Maintenance—Patient. 34Care for the Power Cartridge . 34Calibrating the Power Cartridge. 34Patient Training Checklist . 35Annual Maintenance—Provider .36Introduction . 36Annual Maintenance Check List . 36Checking and Replacing the Power Cartridge. 36Eclipse 5 Monthly Run-Time Cycle . 36Annual Maintenance Procedures . 37Removing the Unit Cover . 37Remove and Replace 9 Volt Battery. 41Remove and Replace HEPA Filter. 42Internal Filters. 42Remove and Replace the CompressorIntake Filter. 44Reinstalling or Replacing the Unit Cover . 46Test Procedures . 47Purity and Flow Rate TestProcedure - Preferred Method . 47Purity and Flow Rate Test ProcedureAlternate Method . 47Assembly and Alarm Verification Tests . 48Record Hours of Operation & SoftwareVersion . 49Electrical Safety Test . 50Cleaning the Eclipse 5. 50Provider Service and Maintenance Record . 51Shipping and Transporting the Eclipse 5 . 52Storing the Eclipse 5 . 52Discarding . 52Troubleshooting, Service, andRepair Procedures . 53System Troubleshooting and Alarms. 54Alarm Conditions and Alarm Codes . 57Malfunction Codes . 59System Schematics and Diagrams . 60Oxygen Circuit . 62Remove and Replace the ATF Module. 62Remove and Replace the Product TankAssembly (PN 4378-SEQ) Eclipse 5 . 66Electronics . 69Remove and Replace the ControlBoard Assembly . 69Remove and Replace the Buzzer Wire Harness. 71Control Board Connector Diagram . 72Remove and Replace the Power ManagerPrinted Circuit Board . 73Compressor . 77Remove and Replace the Compressor Box 77Maintenance and Replacement Parts . 81Preventative Maintenance Parts. 81Replacement Parts List . 81Optional Accessories . 82CAIRE Inc. Customer Service ContactInformation . 833
GENERAL INFORMATIONThis technical manual will familiarize you with Provider-specific information regarding the Eclipse 5 OxygenSystem. Instructions in this manual are intended to help ensure that:- Providers are familiar with Eclipse 5 system components and system principles of operation- Providers are given proper guidance in the use of the Eclipse 5 and its accessories that canbe conveyed to patients- Providers are made aware of the care, diagnostics, maintenance, and repair of the Eclipse 5Warning and Caution StatementsSafety instructions are defined as follows:WARNING:Important safety information for hazards that mightcause serious injury.CAUTIONImportant information for preventing damage to the Eclipse 5.NOTE:Places emphasis on an operating characteristic orimportant consideration.Oxygen Concentrator Technical Service Manual PN 20631679 Rev F4
Internal SymbolsExternal Power IndicatorPower Cartridge (battery)Status GaugePower Cartridge SymbolAAmperes02Oxygen OutputRecycle SymbolFAA Approved Symbol:The U.S. Federal AviationAdministration (FAA) hasapproved this device foruse on-board commercialaircraft.Flow Setting IndicatorPulse Mode OperationDevice operating normally;power buttonISO 7010: Graphical symbols—Safety colorsand safety signs—Registered safety signsThe instruction manual mustbe read. Reg. # M002Keep away from openflame, fire, sparks. Openignition source and smokingprohibited. Reg. # P003Do not smoke near unit orwhile operating unit. Reg. #P002Council Directive 93/42/EEC; concerningmedical devicesAuthorized representative inthe European CommunityThis device complies withthe requirements of Directive93/42/EEC concerningmedical devices. It bears theCE marking as shown.IEC 60417Increase Flow SettingClass II Equipment, DoubleInsulated Reg. # 5172Decrease Flow SettingAlternating Current Reg. #5032ISO 7000; Graphical symbols for use onequipment—Index and synopsisStorage temperature limitationrange is -4 F to 140 F (-20 Cto 60 C). Reg. # 0632Portable humidity range is 15 to 95%.Base humidity range is 30 to 75%.Reg. # 2620Atmospheric pressure limitation. Reg.# 2621Operator’s manual; operating instructions. Reg. # 1641Name and address ofmanufacturer. Reg. # 3082Date of manufacturer. Reg. #2497Catalog Number. Reg. #2493Serial Number. Reg. # 2498This way up. Reg. # 0623Fragile, handle with care.Reg. # 0621Keep away from rain, keep dry. Reg.# 0626Drip Proof Equipment IP22: The Eclipse 5 and theAC power supply provideprotection against the harmfuleffects of ingress of liquids(IP22 per IEC 60529)Stacking limit by number. Reg. # 2403Direct Current Reg. # 5031Type BF applied part (degreeof protection against electricshock). Reg. # 5333CSA CertificationCertified for both the U.S.and Canadian markets, to theapplicable U.S. and Canadianstandards.IEC 60601-1-8Low Priority TechnicalAlarmFCC NOTICE:This device may containCYBLE-022001-00, including theantenna 2450AT18B100 from JohnsonTechnology, complies with par 15 ofthe FCC rules. The device meets therequirements for modular transmitterapproval as detailed in FCC publicNotice DA00-1407. Transmitteroperation is subject to the following twoconditions (1) This device may not causeharmful interference, and (2) This devicemust accept any interference received,including interference that may causeundesired operation.This product may be covered by oneor more patents, US and international.Please visit our website below for thelisting of applicable patents. Pat.: patents.gtls.io.Aircraft Use:CAIRE confirms that this machine meetsthe Federal Aviation Administration(FAA) requirements (RTCA/DO-160,section 21, category M) for all phases ofair travel.FCC Notice21 CFR 801.15: Code of Federal RegulationsTitle 21Federal law restricts thisdevice to sale by or on theorder of a physician.Council Directive 2012/19/EU: waste electricaland electronic equipment (WEEE)Wireless TechnologyTechnology usedBluetoothConnection typesSSP, iAP2, GATTFrequency2402 to 2480 MHzMax RF power output 4 dBmOperating range10m (Class 2)It is recommended that the machine is at aminimum distance of 0.43” (1.1 cm) from thebody during operation. Not applicable to masks,air tub- ing, or accessories.WEEEIEC 60601-1: Medical electrical equipmentPart 1 General requirements for basic safetyand essential performanceOxygen Concentrator Technical Service Manual PN 20631679 Rev F5
INTRODUCTION TO THE ECLIPSE 5 OXYGEN SYSTEMECLIPSE 5AC POWER SUPPLYWITH NEMA POWER CORDPN: 5941-SEQ (three LED model)PN: 20852326 (two LEDmodel)UNIVERSAL CARTDC POWER SUPPLYPN: 5942-SEQPOWER CARTRIDGE(BATTERY)PN: 5991-SEQPN: 7082-SEQHandleControl PanelEDAT Service Port(Not for Patient Use)Air InletFilterOxygenOutlet PortExternal onFAAApprovalIconPower CordRetainerPowerCartridge(battery)Exhaust VentRating Label &Serial NumberLocationPower Cartridge LatchFRONTBACKOxygen Concentrator Technical Service Manual PN 20631679 Rev F6
ECLIPSE 5 OXYGEN SYSTEM SPECIFICATIONSOxygen ConcentratorDimensions (H x W X D)19.3 x 12.3 x 7.1 inches(49.0cm x 31.2cm x 18.0cm)Weight15.0 poundsEclipse 53.4 poundsPower CartridgeFlow SettingsContinuous Flow (measured in Liters Per Minute LPM) Pulse 0.5 to 3.0 LPM (0.5 liter increments)Dose (measured in mL)Settings 1.0-6.0: 16-96mL (8mLincrements) Settings 7-9: 128mL,160mL, 192mLContinuous Flow Accuracy /- 10% or 200ml/min, whichever is greaterOxygen Concentration87–95.6% for all flow settingsMaximum System Pressure14 psig (96.5 kPa)Oxygen Output Pressure5.0 psig (34.5 kPa) nominalOxygen ConcentrationGreen Light Normal OperationYellow Light Warning or Caution, less than 85% 3%Status IndicatorRed Light Flashing Abnormal Operation, less than 70% 5% (Note: only for 3-LED models)Nominal Sound Level48 dB(A)3.0 LPM Continuous Flow40 dB(A)3.0 Pulse Dose ModeLess than 57 dB while alarmingOperating EnvironmentTemperatureHumidityStorage Environment TemperatureHumidityAltitudeNominal Power0.5 LPM Continuous flow 3 LPMContinuous Flow1.0 Pulse Dose Setting6.0 Pulse Dose Setting BatteryChargingNominal Power Cartridge operating time* ContinuousFlow2.0 LPM3.0 LPMPulse Dose (@ 12 BPM)Setting 2.0Setting 6.0Outlet PressureContinuous Flow IndicationAudible Alarm Indicators50º 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 hours* Note: Times will decrease with higher bolus size, breath rate, ambient tem
Oxygen Concentrator Technical Service Manual PN 20631679 Rev F 5 Drip Proof Equipment -IP22: The Eclipse 5 and the AC power supply provide protection against the harmful effects of ingress of liquids (IP22 per IEC 60529) IEC 60601-1-8 Low Priority Technical Alarm FCC NOTICE: This device may contain CYBLE-022001-00, including the
