CAIRE 1000B, Provider Technical Maunal

Page 1: ...PROVIDER TECHNICAL MANUAL Eclipse3 with autoSAT Personal Ambulatory Oxygen System PAOS Model 1000B...

Page 2: ...e 21 Charging Algorithm 24 TABLE OF CONTENTS Training The Patient 25 Introduction 25 Pre Delivery Check List 25 Indications for Use 26 Contraindications 26 Basic Concept Training 26 Safety Guidelines...

Page 3: ...55 Storing the Eclipse 55 Discarding 55 Troubleshooting Service and Repair Procedures 56 System Troubleshooting and Alarms 57 Alarm Conditions and Alarm Codes 60 Malfunction Codes 61 System Schematics...

Page 4: ...inciples of operation Providers are given proper guidance in the use of the Eclipse 3 and its accessories that can be conveyed to patients Providers are made aware of the care diagnostics maintenance...

Page 5: ...gen Outlet Port FAA Approval Icon BACK Power Cartridge Latch Exhaust Vent Power Cartridge Battery FAA Approval Icon Cart Attachment Location Air Inlet Filter EDAT Service Port Not for Patient Use Rati...

Page 6: ...e Humidity 50 F to 104 F 10 to 40 C 10 to 95 Non condensing 82 4 F 28 C Maximum Dew point Storage Environment Temperature Humidity 4 F to 140 F 20 to 60 C Up to 95 Non condensing Altitude 0 13 123 fee...

Page 7: ...ring Continuous Flow and waits 15 seconds for a breath The Eclipse 3 will stay in this modalityuntilabreathisdetected SeePowerCartridgeConservationFeature page26 Power Accessory Specifications AC Powe...

Page 8: ...File MH29443 IEC 60601 1 1988 A1 1991 A2 1995 UN Transportation Tests T1 T8 Electromagnetic Compatibility EN 61000 6 3 2001 EN55022 1998 A1 2001 A2 2003 EN61000 6 1 2001 EN61000 4 2 1995 A1 1998 EN610...

Page 9: ...anual Portable and mobile RF communications equipment can affect Medical Electrical Equipment TheuseofAccessories transducers andcablesotherthanthosespecified withtheexceptionoftransducersandcablessol...

Page 10: ...1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typi cal commercial or hospital environment Voltage dips short interruptio...

Page 11: ...RF transmitters as determined by an electromagnetic site sur vey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with th...

Page 12: ...power of transmit ter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3...

Page 13: ...The system monitors and controls both the power source and the Power Cartridge charger Figure 1 ECLIPSE System Block Diagram ATF CONCENTRATOR MODULE TheEclipseusesapassivesystemtoseparateoxygenfromair...

Page 14: ...within the compressor enclosure serves to efficientlydrawcoolingairinoverthecompressorcylinderswhilesimultaneouslypushingexhaustgasoutoftheconcentrator POWER DISTRIBUTION ThePowerManagertakesexternalp...

Page 15: ...d flow rate and flow mode ON OFF Button Green Indicator This button powers the device ON or OFF The Green Indicator is illuminated when the device is ON Increase or Decrease Setting Buttons Use these...

Page 16: ...and orthePulseDosesettings mL EachtimeyoupowerthedeviceON thepreviousmodeand orsetting has been saved and will be used at start up Do not get wet PowerCartridge battery StatusGauge Thisindicatordispl...

Page 17: ...es Regardlessofsetting thepulseprofileisasimplesquare wavepulsebasedona16mLvolume Referto PulseProfiles tablebelow Pulsedurationsarenolessthan100milli secondsatthebeginningoftheinspiration Therearethr...

Page 18: ...ory effort The LCD will show PS x PS 1 is the most sensitive setting PS 3 is the least sensitive setting Factory defaut is PS 2 HOURS OF OPERATION TheEclipsehourmeterprovidesvaluableinformationonhours...

Page 19: ...port needs EDAT software is capable of sensing and displaying historical event logs and values of components and sensors within the Eclipse system This can be used to determine system faults or user e...

Page 20: ...srequiretheuseofhospitalgradeACpowercordwiththeEclipse Figure 5 Eclipse 3 AC Power Supply TheEclipse3ACPowerSupplydoesnotcontainafan Wheninuse theACPowerSupplyshouldbelocatedinawell ventilated area Lo...

Page 21: ...power on DC DO NOT use the DC supply to power the Eclipse once the vehicle s engine is turned off as this may drain the car s battery POWER CARTRIDGE BATTERY ThePowerCartridgeallowsoperationawayfromA...

Page 22: ...mmercialairlineflightforinternationaltravel removethePowerCartridgeand properly package When shipping the Eclipse for any reason remove the Power Cartridge from the Eclipse IfthePowerCartridgegetstoow...

Page 23: ...urefallswithintheselimits theEclipsewillresumenormaloperation Operationnearthesetemperaturelimitswill not damage the Power Cartridge but are in place to ensure that the service life of the Power Cartr...

Page 24: ...ventuallyfall Whenthechargingcurrentfor eachPowerCartridgehasfallenbelow5 oftheratedcapacity chargingiscompleteandthePowerCartridgechargerisshut off The software will only charge when the Power Cartri...

Page 25: ...IST Before delivering the device check and log the status of the following Parts Inventory Verify that each Eclipse is provided to the patient with the following items a Users Manual a Quick Start Gui...

Page 26: ...fetyWarnings Cautionswitheachpatient Inaddition provider shouldcarryoutariskassessmentpriortoinstallationoftheEclipsetoassureproperconnectionandcompatibilitywithother equipment the patient may be usin...

Page 27: ...dindicatorcanbefound in the Eclipse Users Manual CAUTION Some patients are highly mobile and may use the device under varying circumstances Make sure your patient or patient caregiver completely under...

Page 28: ...ate the procedure for your patient Set the prescribed flow using the increase or decrease buttons Verify that the patient is able to adequately trigger the oxygen delivery while speaking sitting quiet...

Page 29: ...selectingsetting1 2or3 1 most sensitive 3 leastsensitive ThedefaultsettingforunitscomingfromSeQualis 2 ToadjustthePulseSensitivity performthe following steps 1 Have the patient sit quietly with the na...

Page 30: ...t the power cord into the AC Power Supply 3 Plug the power cord into a grounded outlet 4 The power supply LED displays green to indicate that the AC Power Supply is drawing power The External Power Pr...

Page 31: ...mode will also not operate above 96 mL Ensure adequate clearance around the DC Power Supply and the Eclipse Ensure the DC Power Supply and Eclipse are secured in the vehicle so that is does not become...

Page 32: ...by vehicle If so show your patient how to safely use the Eclipse while driving Refer to the previous section on Connecting the DC Power Supply for proper setup of the Eclipse system in a vehicle Figur...

Page 33: ...xtreme temperatures Extreme heat or cold may impair operation and damage the device and degrade the Power Cartridge WARNING NOTE Actual performance of the Eclipse may vary depending upon usage conditi...

Page 34: ...the Power Cartridge DO NOT use DC or ACPowerAdaptersonanaircraft ThepatientmustensurethattheyhaveanadequatenumberofsparePowerCartridgesto last for the duration of their trip Visitourwebsite www sequal...

Page 35: ...t information for the tubing and cannula CLEAN THE CABINET AND CONTROL PANEL AND POWER SUPPLIES To clean the cabinet Control Panel or power supply do the following 1 Turn OFF the Eclipse and discon ne...

Page 36: ...he patient will need an AC Power Supply to recharge the Power Cartridge and should be able to run the Eclipse from AC power for at least 5 hours The patient should follow these steps 1 Install the Pow...

Page 37: ...se Panel Buttons and Indicators Alerts and Alarms Power Cartridge Power Level Selecting Flow Mode and Setting Selecting Continuous Flow Mode Selecting Pulse Dose Mode with autoSAT Technology Adjusting...

Page 38: ...Pulse Dose Mode and alarm functions Replace compressor intake filter Perform electrical safety test Required only for PN 5701 Hospital Grade Power Cord Replace HEPA filter CHECKING AND REPLACING THE...

Page 39: ...utting pliers Small cable ties ESD Mat or approved ESD system Figure 11 Maintenance Tools REMOVING THE UNIT COVER 1 Disconnect power supplies and remove Power Cartridge before removing the unit cover...

Page 40: ...er pop the bottom end off first and rotate it towards the handle Be careful not to tear the Control Panel ribbon cable that is attached to the front cover Figure 13 Opening the Front Cover CAUTION The...

Page 41: ...This may damage the pins of the header Figure 14 Removing the Membrane Panel Overlay Ribbon Cable 7 Disconnect the silicone tube from the oxygen outlet tube at the top of the cover First cut the cabl...

Page 42: ...cting the Oxygen Outlet Tube 8 Lay the front panel away from Eclipse Inspect PEM Nut anchors in the front cover assembly Perform necessary maintenance Figure 16 Front Cover Removal Once the cover has...

Page 43: ...mpartment located at the bottom right corner of the unit Figure 17 Removing the 9 volt Battery 3 Disconnect the 9 volt battery harness 4 Remove and replace the 9 volt battery Figure 18 Disconnecting t...

Page 44: ...to the HEPA filter Figure 19 Removing the HEPA Filter 2 Disconnect both tubes from the filter hose barbs Figure 20 Disconnecting the HEPA Filter 3 Remove and replace the filter NOTE Always cut the hea...

Page 45: ...gure 21 Installing the HEPA Filter 5 Re install cable ties on silicone tubes NOTE Route tubing as shown in Figure 22 Install cable ties loosely as shown CAUTION Once the silicone tubes are disconnecte...

Page 46: ...46 2 Unscrew the wing nut that hold the HEPA filter Figure 23 Wing Nut 3 Unscrew the Clear HEPA filter and discard Filter small O Ring Figure 24 Unscrewing the HEPA Filter 4 Install the new small O ri...

Page 47: ...R INTAKE FILTER Replace the compressor intake filter annually or more often as needed The compressor intake filter may become clogged depending upon the amount of contaminants in the air smoke dust di...

Page 48: ...es attached to each end of the filter body 3 Install a new filter by pushing each tube completely over the barb on the filter body Verify flow direction is correct 4 Reconnect silicone tubes to the fi...

Page 49: ...or a minimum of 20 minutes prior to re installing the cover to check for a smooth and quiet calibration to be replaced by operation Tore installthecover followthestepsusingthereverseorder Ensurethatth...

Page 50: ...oncentrator on and set the target flow on the Eclipse to 3 LPM continuous flow Allow the Eclipse to stabilize can take up to 10 minutes Verify the O2 concentration and O2 flow rate are within specific...

Page 51: ...he Control Panel by pressing each of the Increase Decrease Pulse Dose Mode and No Smoking buttons and observe that the Eclipse buttons function normally 5 Press the Delivery Mode button and set the Ec...

Page 52: ...to 00 000 Alarm Code ALRM Displays most recent alarm code Additional alarm codes will also be displayed if present by continuing to press the key Pulse Sensitivity PS Hours of Operation HRS 9 volt Ba...

Page 53: ...er Supply from the electrical safety analyzer 5 If the AC Power Supply measures leakage current greater than the criteria in step 3 please return it to SeQual for service 6 EDAT may be utilized to rec...

Page 54: ...ftheEclipseisopened theflowrate purity and alarm status should be verified per the Test Procedures in this manual EDAT may be utilized to record Eclipse device status and dates of service Eclipse Seri...

Page 55: ...artridge when storing the device The Eclipse must be turned on and run for 2 hours each month to ensure proper operation performance Tip Running the power cartridge down completely and recharging it w...

Page 56: ...ures CAUTION The Eclipse contains electrostatic sensitive components Do not open or handle except at a static free workstation Do not remove cover without ESD protection NOTE To adaquately troubleshoo...

Page 57: ...lug it in to AC power and allow to recharge fully Replace battery if it does not come back within specification Any Power Source Yellow Light is Blink ing and Unit is beeping Low or No Oxygen Flow Pre...

Page 58: ...e to come up to Green Light operation Other Contact Chart TS for RMA service Eclipse Red Light and Alarms Battery has become Too Hot FAIL Condition Displayed FAIL XX Battery is too Hot and will not op...

Page 59: ...r DC Unit will beep for loss of external power AC power is loose or not connected Plug device directly into known good AC outlet extension cord and com puter strips are not recommended DC power is loo...

Page 60: ...O2 85 OFF Flashing OFF OFF PerformAnnualFilterPMMaintenance Ifconditionpersists service is required O2Concentration 70 004 O2 70 OFF OFF Flashing 3 Beeps PerformAnnualFilterPMMaintenance Ifconditionp...

Page 61: ...wEclipsetocoolfor30Minutes VerifyfunctionalityofPMfan Checktoensureventsarenot obstructed Compressor Motor Stalled FAIL 94 CheckCompressorwiresfordamage VerifyfunctionalityofPMPCB Verifyfunctionalityo...

Page 62: ...onal Ambulatory Oxygen System Provider Technical Manual 62 System Schematics and Diagrams SIMPLIFIED BLOCK DIAGRAM Figure 31 Eclipse 3 Oxygen System Simplified Block Diagram Figure 32 Top Case Compone...

Page 63: ...gen System Provider Technical Manual 63 Figure 33 Bottom Case Components ATF Module Product Tank Compressor Box Compressor Intake Filter Control Board Battery Bridge PC Board HEPA Filter Power Manager...

Page 64: ...er Technical Manual 64 Figure 34 Bottom Case Components Eclipse 3 Manufactured December 2011 and above ATF Module Product Tank Compressor Box Compressor Intake Filter Control Board Battery Bridge PC B...

Page 65: ...as described in the section Remove and Replace the Unit Cover 2 Cut the green tie as shown below and disconnect the silicone tube that goes into the product port of the ATF this tube comes from the P...

Page 66: ...screws and washers M4 Flat washer P N 6985 04 as shown below Figure 37 Remove ATF Module from Eclipse Case 7 Lift the ATF Take off the 3 grommets Disconnect the wire harness from the gearbox of the A...

Page 67: ...before installing Tighten screws but DO NOT squash the grommets 2 in lbs maximum NOTE Inspect all tubing before securing with a cable tie CAUTION Remove caps on ATF ports ONLY before connecting the tu...

Page 68: ...lacement 16 Installation of the Unit Cover on the unit is described in the Remove and Replace of the Unit Cover REMOVE AND REPLACE THE PRODUCT TANK ASSEMBLY PN 6138 SEQ ECLIPSE 1 ECLIPSE 2 EARLY ECLIP...

Page 69: ...ties Inspect the tubing to ensure the tubing is not kinked 7 Install the silicone tube that comes from the ATF product port to the bottom Product Tank as shown in Figure 40 on previous page Secure wi...

Page 70: ...Use the picture below as an aid to ensure proper routing of oxygen tubing in the Eclipse Figure 42 Oxygen Tubing Routing Tube from ATF Module to Product Tank 4 5 long Tube from Product Tank to Flow C...

Page 71: ...failure of one of its components then follow steps for Situation 3 Situation 3 If you are just replacing the HEPA filter then follow the steps in the PM section for Remove and Replace HEPA Filter Sit...

Page 72: ...screws Set aside for re installation Figure 44 Figure 44 Remove Screws 5 Lift out the old product tank PN 6138 SEQ Set aside for RMA return or scrap Install new Product Tank PN SP4378 SEQ or 4378 SEQ...

Page 73: ...t tank and locate the screw hole on the back case cover for the old product tank securing arm that was to the right top side of compressor See Figure 47 Figure 47 Install securing arms 4 Locate the Pr...

Page 74: ...eplace the Front Cover Assy on page 40 2 Remove the Front Cover Assy completely outlet tubing and front membrane ribbon cable Set aside 3 LocatethemetalProductTankandcutthecabletiesfromtheATFtotheProd...

Page 75: ...ws that hold the securing straps and the product tank in place remove the screws Set aside for re installation Figure 50 Fig 50 Remove screws 8 Lift out the old product tank PN 4378 SEQ Set aside for...

Page 76: ...Power Manager PC Board Communications ProportionalValve wire harness and Buzzer wire harnesses as shown in Figure 51 Cable Tie Screw Tube from Product Tank Tube from the Proportional Valve Buzzer Conn...

Page 77: ...e Placethe2screwsinthesheetmetalbracketasshowninFigure52 Inspectthetubing to ensure the tubing is not kinked 8 Lower the Control Board Assembly into the Unit Case only to where the aligning pins go th...

Page 78: ...stall a new buzzer apply a ring of cyanoacrylate adhesive Super Glue around the inlet hole as shown in Figure 53 Figure 53 Bonding the Buzzer to the case 5 Placebuzzerasshowninfigure54 Ensurethatthebu...

Page 79: ...e figure below as an aid to ensure proper connection of wire harnesses to the Power Manager printed circuit board Figure 55 Control Board Connector Diagram Buzzer Connector Air Inlet Temperature Data...

Page 80: ...artridge and unscrew the 4 screws M3x12 Pan Head SEM Screw P N 6974 312 SEQ shown in Figure 56 Figure 56 Battery Bridge Board Removal 2 Remove the Unit Cover as described in the section Remove and Rep...

Page 81: ...anager PC Board Removal 4 Unscrew the 2 screws M2x10 Pan Head Machine Screw P N 6961 210 SEQ holding the fan shown in Figure 49 Remove fan 5 Remove the Exhaust Tube shown in Figure 58 Figure 58 Exhaus...

Page 82: ...sition the Power Manager PCB into the slots on the Unit Case 8 Install the fan with the 2 screws and lightly tighten as shown in Figure 57 Apply Loctite 425Thread Locker on the tips of the screws befo...

Page 83: ...e below as an aid to ensure proper connection of wire harnesses to the Power Manager printed circuit board Figure 60 Power Manager PC Board Connector Diagram Early Production E3 Compressor Blower ATF...

Page 84: ...4 POWER MANAGER PCB IDENTIFICATION Use the picture below as an aid to ensure proper connection of wire harnesses to the Power Manager printed circuit board Figure 61 Previous Separate PM pcb and BBB p...

Page 85: ...63 Screws 1 2 Remove the Unit cover as described in section Remove and Replace the Unit Cover 1 3 Disconnect the 5 wire harnesses as shown in Figure 54 Remove the Battery Bridge pcb BBB pcb as shown...

Page 86: ...ust Tube 1 6 Pull the Power Manager pcb 1 out of the case Gently push the compressor box away from the Power Manager pcb about 1 8 Slide the board and the cabling out from under the edge of the compre...

Page 87: ...g58 GentlypushtheCompressorBoxaway from the Power Manager pcb by 1 8 Connect the 2 wire harnesses Ext Power ATF harness and the Control Board Ribbon Cable Note Routethewiringundertheedgeofthecompresso...

Page 88: ...ck over Install the 2 clips that come with the power manager board SP5932 1 SEQ set Note There is a right and left clip Large gap is on the right ensure you get both the metal heat sink and pcb corner...

Page 89: ...r is a limited wear component and may require servicing during the lifetime of the device The point of service will be dependent on factors such as operation time flow settings and environmental condi...

Page 90: ...Power Wire Harness Compressor Signal Wire Harness 3 Disconnect the 3 wire harnesses shown in Figure 72 Figure 72 Compressor Box electrical connections 4 Remove the Exhaust Tube as shown in Figure 73 F...

Page 91: ...fitting vinyl caps or vinyl electrical tape Figure 74 Removal of Compressor Pressure and Vacuum Hoses from ATF Module CAUTION Once the braided hoses are disconnected from the ATF Module the ATF Module...

Page 92: ...n previous page Secure joints with cable ties 11 Use a cable tie to secure the silicone tube to the braid tube to ensure that there is NO kinking on the bend as shown on Figure 74 on previous page Han...

Page 93: ...Supply 5942 SEQ Foot bottom 6956 SEQ Handle 6963 SEQ Inlet Filter 7028 SEQ Membrane Panel Overlay Eclipse 3 SP4225 SEQ Nut Outlet 2777 SEQ Outlet Assembly Oxygen 3922 SEQ Power Manager PCBA Eclipse 3...

Page 94: ...SEQ If your physician has prescribed an optional hu midifier youmayneedtousetheSeQualHumidifierAdapter Followtheinstructionsforuse AttachtheHumidifierAdapterto theoxygenoutletportoftheEclipseandthento...

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