Newport Medical Instruments, Inc. N E360 VENTILATOR

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Newport Medical Instruments, Inc.NEWPORT e360 VENTILATORService ManualSER360 Rev. A11/06NEWPORT MEDICAL INSTRUMENTS, INC.1620 Sunflower AvenueCosta Mesa, CA 92626 USATel: 714.427.5811Tel: 800.451.3111 (USA only)Fax: 714.427.0489Customer Service ext. 2820050www.NewportNMI.comemail: Info@NewportNMI.com

TABLE OF CONTENTSSection 1.INTRODUCTIONSection 2 .MAINTENANCE, OVERHAUL& SOFTWARE UPGRADESection 3 .TROUBLESHOOTING GUIDESection 4 .COMPONENT REMOVAL& REPLACEMENTSection 5 .CALIBRATION PROCEDURESSection 6 .OPERATIONAL VERIFICATIONPROCEDURESection 7 .CLEANING and MAINTENANCEAppendix A .THEORY OF OPERATIONAppendix B .ORDERING & CONTACTINFORMATIONAppendix C .DIAGRAMSSER360 A1106

1. INTRODUCTIONIntroduction .Definitions .General Warnings.General Cautions .Warranty .Factory Service.Copyright Information .Contact Information .SER360 A11061-11-11-11-21-21-31-31-3

SECTION 1INTRODUCTIONIt is very important to read and understand all of the information inthis manual before attempting to service the e360 Ventilator.Please review all warnings and cautions in this manual beforeattempting to service the e360 ventilator.DEFINITIONSWARNING A WARNING describes a condition that can causepersonal injury.Caution A Caution describes a condition that can causedamage to equipment.NOTE: A NOTE emphasizes information that is important orconvenient.Inspection: examination of actual condition.Service: measures to maintain specified condition.Repair: measures to restore to specified condition.Maintenance: inspection, service, and repair where necessary.Preventive Maintenance: maintenance performed at regularintervals.Operational Verification: a routine verification procedure toensure proper operation.Overhaul Procedure: a procedure for replacing key componentsat regular intervalsGENERAL WARNINGSPlease review all warnings and cautions in this manual beforeattempting to service the ventilator.Warnings and Cautions appear throughout this manual where theyare relevant. The Warnings and Cautions listed here applygenerally any time you work on the ventilator.SER360 A11061-1

INTRODUCTIONWARNINGTo maintain grounding integrity, connect only to a hospitalgrade receptacle. Always disconnect power supply beforeservicing the e360 ventilator.DANGER: there is a risk of explosion if used in the presence offlammable anesthetics.Before returning to patient use, the e360 ventilator must passthe operational verification procedure.All e360 ventilator service or repair must be performed by atechnician authorized and trained by Newport MedicalInstruments.Use extreme caution when working inside the e360 ventilatorwhile it is connected to a power source.GENERAL CAUTIONSCautionUse standard antistatic techniques when working inside thee360 ventilator or handling any electronic parts.Clean all external parts of the e360 ventilator prior to service.Use only dry, clean compressed air and medical grade oxygen.Water in the air or oxygen supply can cause equipmentmalfunction and damage.Mains voltage must correspond to the voltage range selectedon the power module of the e360 ventilator. Always replace anopen fuse with one of correct type and rating.Do not place containers of liquids near the e360 ventilator.Liquids that get into the e360 ventilator can cause equipmentmalfunction or damage.NOTE: Use the tools specified in the manual to perform specificProcedures.WARRANTYThe e360 ventilator comes with a two (2) year conditionalwarranty. The warranty covers any defect or malfunction thatoccurs due to normal use. The warranty does not cover any1-2SER360 A1106

SECTION 1scheduled maintenance. See the e360 Ventilator OperatingManual for the conditions of this warranty.Federal Law in the United States requires traceability of thisequipment. Please fill out the self-addressed Warranty RegistrationCard included with the product and return it to Newport promptly.Or register online at www.NewportNMI.com.FACTORY SERVICEScheduled maintenance or repair services are available from theNewport Technical Service department. See Appendix B forinstructions on returning your ventilator for service. Newport’sannual price list includes current pricing for scheduledmaintenance and labor rates. To obtain a copy of the price list,please contact your local Newport representative or contact ourCustomer Service department.COPYRIGHT INFORMATIONCopyright 2006 Newport Medical Instruments, Inc. all rightsreserved. The Newport e360 Ventilator system is manufactured inaccordance with Newport Medical Instruments, Inc. proprietaryinformation and is covered by the following Patent, #6,439,229.The information in this manual is the sole property of NewportMedical Instruments, Inc. and may not be duplicated withoutpermission. This manual may be revised or replaced by NewportMedical Instruments at any time and without notice.CONTACT INFORMATIONAddress:Newport Medical Instruments1620 Sunflower AvenueCosta Mesa, California, USA 92626Phone numbers: Toll-free within the United States: 800.451.3111Worldwide: 1.714.427.5811SER360 A1106Fax numbers:Main Fax: 1.714.427.0489Technical Service Fax: e@NewportNMI.com1-3

INTRODUCTIONDepartmentextensions:Customer Service: 282Technical Service: 500 (24-hour pager activated)Clinical Support: 123 (24-hour pager)Corporate Office Monday through Friday, 8:00 am to 5:00 pmhours:(USA Pacific Time)EU Representative: Newport Medical InstrumentsAtt. Robert Brinkc/o Braun & Co.19 Pasture Rd.Barton-on-HumberNorth LincolnshireDN18 5 HN, Englandtel: 44.77 68 231311Fax: 44.1652.6333991-4SER360 A1106

2. MAINTENANCE, OVERHAUL& SOFTWARE UPGRADEMaintenance & Overhaul Intervals. 2-1General Warnings. 2-1General Cautions . 2-2Parts Required / Tools Required . 2-2Maintenance Procedures . 2-3– Inlet Water Trap Filters & O-rings Assembly 2-3– Exhalation Valve Adapter . 2-4– Exhalation Valve Diaphragm, Seal& O-Ring. 2-5– Emergency Relief Diaphragm . 2-5Overhaul Procedures . 2-6– Inlet Water Trap Filters & O-rings Assembly 2-6– Air and Oxygen Inlet Regulator Rebuild . 2-7– Exhalation Valve Adapter . 2-7– Exhalation Valve Diaphragm/PoppetAssembly . 2-8– Cooling Fan Filter & Guard . 2-8– Emergency Relief Diaphragm . 2-9– Emergency Intake Diaphragm . 2-9– Inhalation Outlet Check Valve. 2-10– Internal Battery . 2-10– Tubing . 2-10Software Upgrade Procedure . 2-11General Information . 2-11Upgrade Procedure. 2-11Circuit Test & Diagnostic . 2-13Software Upgrade Form . 2-19SER360 A1106

MAINTENANCE & OVERHAUL INTERVALSSECTION 2The Level I Preventive Maintenance procedure should beperformed once a year or every 5000 hours, whichever comes first.Perform the Level 2 Overhaul Procedure, every 5 years or 25,000hours, whichever comes first.GENERAL WARNINGSWARNINGAll servicing or repair of the e360 ventilator must be carried outoff patient.Hazardous voltages are present inside the e360 ventilator. Useextreme caution if it is necessary to work inside the ventilatorwhile it is connected to a power source. Disconnect electricalpower, air and oxygen sources before attempting anydisassembly. Failure to do so could result in injury to servicepersonnel or equipment.To maintain grounding integrity, the e360 ventilator must beconnected to a hospital grade receptacle when in use.DANGER: There is a risk of explosion if the e360 ventilator isused in the presence of flammable anesthetics.Before returning to patient use, the e360 ventilator must passthe Operational Verification Procedure.All service repairs of the e360 ventilator must be performed bya service technician authorized and trained by Newport MedicalInstruments.To prevent damage from ESD and possible failure of the e360ventilator, use standard anti-static techniques when workinginside the e360 ventilator, handling circuit boards or otherelectronic components.SER360 A11062-1

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADEGENERAL CAUTIONSCautionClean all external parts of the e360 ventilator prior to service.Use only dry, clean compressed air and medical grade oxygen.Water in the air or oxygen supply can cause ventilatormalfunction or damage.Mains voltage must correspond to the voltage range specifiedon the e360 ventilator Power Entry Module. Always replacefuses with those of correct type and rating.Keep all liquids away from the e360 ventilator. Liquids in thee360 ventilator can cause malfunction or damage.Always use standard antistatic techniques when working insidethe e360 ventilator or handling any electronic parts.TOOLS REQUIREDNOTE: Use the tools specified in the manual to perform specificprocedures. Large Phillips screwdriverMedium Phillips screwdriverNeedle Nose pliersPARTS REQUIREDPreventive Maintenance Kit2-2The Preventive Maintenance Kit (PMK360A) includes the followingitems:Part NumberQuantityDescriptionJFK100P2JAR Filter KitADP2105M1Exhalation Valve AdapterDIA1800M1Emergency Relief DiaphragmSEL1800M1Exhalation Valve SealORG1200P1O-Ring, Exhalation Flow SensorDIA1810M1Exhalation Valve DiaphragmSER360 A1106

Overhaul KitSECTION 2The Overhaul Kit (OVL360A) includes the following items:Part NumberQuantityDescriptionJFK100P2JAR Filter KitRRK1800P2Regulator Rebuild KitGRD1800P1Cooling Fan Filter & GuardADP2105M1Exh. Valve AdapterPPT1805A1Exh. Valve Dia & Poppet AssyORG1200P1O-Ring, Exhalation Flow SensorDIA1800M1Emergency Relief DiaphragmVLV100P1Emergency Intake DiaphragmVLV2100M1Inhalation Outlet Check Valve DiaphramBAT1800P1Internal BatteryMAINTENANCE PROCEDURESWARNING: Disconnect electrical power, air and oxygensources before attempting any disassembly.Inlet Water Trap Filters & O-ring Assembly12SER360 A1106Figure 2-1 Inlet Water Trap Filter ReplacementUnscrew the collection bowl from the inlet water trap.Unscrew the filter holder.2-3

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE34Remove and replace the inlet filter and O-ring.Reinstall the filter holder and reassemble the water trapassembly.RetainingLatchAdapter LipValveAdapterADP2105MExhalation Valve Adapter12342-4Figure 2-2 Exhalation Valve Adapter ReplacementAccess the Exhalation Valve Adapter by lifting the RetainingLatch and removing the Exhalation Valve and Exhalation FlowSensor, see Figure 2-2 above.To remove the silicon Exhalation Valve Adapter, use your fingerto grasp the Adapter and pull it straight out.To replace the Exhalation Valve Adapter, orient the Adapter liptowards the inside of the instrument and press into place.Ensure that the Adapter is properly seated before re-installingthe Exhalation Valve and Exhalation Flow Sensor.SER360 A1106

SECTION 2Exhalation Valve Diaphragm, Seal & O-RingExh. ValveNut CollarNUT1802MExh. Valve CapCAP2112MCAP1803MDIA1810MPPT1800MDiaphragmPoppet 0PExh. Valve BodyBDY2103M12345ORG2127PFigure 2-3 Diaphragm, Seal & O-Ring ReplacementUnscrew the Exhalation Valve Nut Collar and lift off. Then liftoff the Exhalation Valve Cap and Diaphragm/Poppet Assy.Disassemble the Diaphragm/Poppet Assy.Reverse step 2 to install the new DIA1810M and SEL1800M.Reverse step 1 to reassemble the Diaphragm/Poppet Assy,Exhalation Valve Cap, and Exhalation Valve Nut Collar.Locate and replace O-ring (ORG1200P) inside the ExhalationValve Body, see Figure 2-3.Emergency Relief DiaphragmInh. Outlet AssyFigure 2-4 Inhalation Outlet AssemblySER360 A11062-5

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADEOutlet RetainingScrewsInhalationAdapter123456OVERHAUL PROCEDURESInhalationOutlet e CapFigure 2-5 Emergency Relief Diaphragm ReplacementAccess the Inhalation Outlet Assembly by removing the LowerRight Front Panel, see Figure 2-4 above.Remove the Inhalation Outlet Assembly by removing the tworetaining screws, see Figure 2-5 above.Remove 4 screws from Emergency Valve Cap to expose theEmergency Relief Valve.Insert finger and pull the Emergency Relief Diaphragm(DIA1800M) out of Inhalation Outlet Block.Replace the Emergency Relief Diaphragm.To reinstall components and assembly, reverse the aboveprocedure.WARNING: Disconnect electrical power, air and oxygensources before attempting any disassembly.Inlet Water Trap Filter and O-ring AssemblyTo replace the Inlet Filter and O-ring assemblies, follow theprocedures given in the Preventive Maintenance at the beginningof this section.2-6SER360 A1106

SECTION 2Air and Oxygen Inlet Regulator RebuildDiaphragmCoverSpringO-RingSlip RingFigure 2-6 Inlet Regulator RebuildTo remove/install the Air and Oxygen Inlet Regulator, follow theprocedures in Section 4 of this manual, “Removal of Servo Valves,Regulators, Inlet Block and Flow Sensor Block”.NOTE: Inlet Regulators must be outside of the Ventilator for disassembly and re-assembly.To install the Air and Oxygen Inlet Regulators Rebuild Kits, refer toFigure 2-6 and do the following:12Unscrew the brass cover from the regulator (no tool should beneeded) and remove the spring, diaphragm, diaphragmwasher, seat with O-ring, small spring, and ball (see Figure2-6).Replace the used parts, reversing the disassembly, with theparts from the Regulator Rebuild Kit P/N (RRK1800P).NOTE: The Regulator must be in a vertical position in order toreassemble the Kit components.3Install the Regulator brass cover, hand tight and ensure allcomponents are aligned.NOTE: This procedure is the same for both the air and the oxygenregulators.Exhalation Valve AdapterTo replace the Exhalation Valve Adapter, follow the proceduresgiven in the Preventive Maintenance at the beginning of thissection.SER360 A11062-7

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADEExhalation Valve Diaphragm/Poppet AssemblyRefer to Drawing 2-31234Unscrew the Exhalation Valve Nut Collar and lift off. Then liftoff the Exhalation Valve Cap and Diaphragm/Poppet Assembly.Replace complete Diaphragm/Poppet Assembly (p/n PPT1805A).Reverse step 1 to reassemble the Diaphragm/Poppet Assembly,Exhalation Valve Cap, and Exhalation Valve Nut Collar.Locate and replace O-ring (ORG1200P) inside the ExhalationValve Body, see Figure 2-3.Cooling Fan Filter & GuardCooling FanFilter & GuardFigure 2- 7 Filter and Guard Assembly ReplacementReplace the Cooling Fan Filter and Guard Assembly (GRD1800P),see Figure 2-7.2-8SER360 A1106

SECTION 2Emergency Relief DiaphragmEmergency Intake DiaphragmTo replace the Emergency Relief Diaphragm, follow theprocedures given in the Preventive Maintenance at the beginningof this section.Mixing BlockRetaining Screws (2)Mixing BlockEmergencyIntake ValveEmergency IntakeValve RetainingScrews (2)123456SER360 A1106Figure 2-8 Emergency Intake Diaphragm ReplacementRemove Top Cover following procedure in Section 4 of thismanual, “Removal of Top cover”.Remove Pneumatics Panel following procedure in Section 4 ofthis Manual, “Removal of Pneumatics Panel Assembly”.Remove Inspiratory Flow Sensors following procedure inSection 4 of this manual, “Removal of Inspiratory FlowSensors”.Remove two Emergency Intake Valve retaining screws, seeFigure 2-8 above.Remove the Emergency Intake Valve using Needle NosePliers.Replace the Emergency Intake Diaphragm (VLV100P) andreinstall assembly by reversing procedure above.2-9

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADEInhalation Outlet Check ValveInhalation OutletCheck Valve12345Figure 2-9 Inhalation Outlet Check ValveRemove the Mixing Block by removing the two retainingscrews, see Figure 2-8.Remove the Inhalation Adapter from the Inhalation OutletAssembly, see Figure 2-5.Insert finger and push out the Inhalation Outlet Check Valve,see Figure 2-9.Replace the Inhalation Outlet Check Valve Diaphragm(VLV2100M).To reinstall components and assembly, reverse aboveprocedure.Internal BatteryTo remove/install the Internal battery, follow the procedures inSection 4 of this manual, “Removal of Internal Battery”.Caution: To avoid discharging battery voltage, do not allowany metal object (including tools) to touch battery connectors.Warning: Observe correct polarity when reconnecting batteryconnectors.TubingThe tubing inside the e360 ventilator does not need to be replacedat any predetermined time interval; however, Newport is awarethat tubing may occasionally need replacing. During the overhaulprocedure, carefully inspect all tubing for degradation, cracks, or2-10SER360 A1106

SECTION 2brittleness. If the tubing indicates any of those symptoms, replaceas necessary.If tubing needs to be replaced, please contact Customer Serviceand order the e360 Tube Replacement Kit.Refer to the e360 System Pneumatic Diagram (SPD2100A)located in Appendix C to cut each tube to length and replace theworn tubing in the e360 ventilator.Upon CompletionAfter overhaul is completed, perform a complete electronic andpneumatic calibration as outlined in Section 5 of this manual andthe Operation Verification Procedure as provided in Section 6.e360 SOFTWARE UPGRADE PROCEDUREGENERAL INFORMATIONThe following items are required for software upgrade: Latest Software on USB Flash Drive Software Upgrade Instructions NMI Reusable Patient Circuit (PBC340A) or equivalent Cap to plug end of patient circuit (CAP100P) or equivalentUPGRADE PROCEDURENote: Follow this procedure to reload software after performing aMain Board, Display Board or Single Board Computer componentreplacement.123456SER360 A1106Confirm the e360 ventilator is OFF and connect AC powercord to the AC wall outlet (see Figure 2-13 for Power EntryModule location).Press and hold the “Accept” button and turn ON the power.Release the “Accept” button when NMI Logo Screen isdisplayed.Wait for few minutes until the Software Download/DiagnosticsMode screen is displayed, see Figure 2-11.Connect USB Flash Drive (with latest software) to the USBport on the Back Panel of the e360 ventilator (see Figure 2-13for USB port location).Press “Start Download” on touch screen (Figure 2-11). Thee360 ventilator will sound a short beep. “Touch Selection toBegin” message on screen will change to a flashing message:“downloading .” Wait 15 – 20 minutes for softwaredownload to complete.2-11

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE789Figure 2-11 Software Download/Diagnostics Mode ScreenWhen software download is completed, ventilator will sound ashort beep. “Download Complete” message will appear onthe screen and flashing stops.Turn OFF the power of the e360 ventilator.Wait at least 10 seconds and turn the e360 ventilator powerback ON.10 Wait until “Ventilation Standby” screen appears.11 Press “Start Ventilating” to begin ventilating.12 NOTE: Because Air/O2 gas supplies are not connected youwill get

This manual may be revised or replaced by Newport Medical Instruments at any time and without notice. CONTACT INFORMATION Address: Newport Medical Instruments 1620 Sunflower Avenue Costa Mesa, California, USA 92626 Phone numbers:Toll-free within the United States: 800.451.3111 Worldwide: 1.714.427.5811 Fax numbers: Main Fax: 1.714.427.0489 Technical Service Fax: 1.714.427.0572 Website: www .

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