Newport E360 Service Manual

Newport E360 Service Manual

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Newport Medical Instruments, Inc.
N
EWPORT
e360 V
Service Manual
SER360 Rev. A
ENTILATOR
11/06
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 Sunflower Avenue
Costa Mesa, CA 92626 USA
Tel: 714.427.5811
Tel: 800.451.3111 (USA only)
Fax: 714.427.0489
Customer Service ext. 282
www.NewportNMI.com
email: Info@NewportNMI.com
0050

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Summary of Contents for Newport E360

  • Page 1 Newport Medical Instruments, Inc. e360 V EWPORT ENTILATOR Service Manual SER360 Rev. A 11/06 NEWPORT MEDICAL INSTRUMENTS, INC. 1620 Sunflower Avenue Costa Mesa, CA 92626 USA Tel: 714.427.5811 Tel: 800.451.3111 (USA only) Fax: 714.427.0489 Customer Service ext. 282 www.NewportNMI.com email: Info@NewportNMI.com...
  • Page 3 TABLE OF CONTENTS Section 1..........INTRODUCTION Section 2 ....MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Section 3 ....TROUBLESHOOTING GUIDE Section 4 ......COMPONENT REMOVAL & REPLACEMENT Section 5 ....CALIBRATION PROCEDURES Section 6 ....OPERATIONAL VERIFICATION PROCEDURE Section 7 ....CLEANING and MAINTENANCE Appendix A ....THEORY OF OPERATION Appendix B ......ORDERING &...
  • Page 5: Table Of Contents

    1. INTRODUCTION Introduction ............1-1 Definitions .............. 1-1 General Warnings..........1-1 General Cautions ..........1-2 Warranty ..............1-2 Factory Service............1-3 Copyright Information ..........1-3 Contact Information ..........1-3 SER360 A1106...
  • Page 7: Introduction

    SECTION 1 INTRODUCTION It is very important to read and understand all of the information in this manual before attempting to service the e360 Ventilator. Please review all warnings and cautions in this manual before attempting to service the e360 ventilator.
  • Page 8: General Cautions

    Before returning to patient use, the e360 ventilator must pass the operational verification procedure. All e360 ventilator service or repair must be performed by a technician authorized and trained by Newport Medical Instruments. Use extreme caution when working inside the e360 ventilator while it is connected to a power source.
  • Page 9: Factory Service

    Manual for the conditions of this warranty. Federal Law in the United States requires traceability of this equipment. Please fill out the self-addressed Warranty Registration Card included with the product and return it to Newport promptly. Or register online at www.NewportNMI.com. FACTORY SERVICE Scheduled maintenance or repair services are available from the Newport Technical Service department.
  • Page 10 Technical Service: 500 (24-hour pager activated) Clinical Support: 123 (24-hour pager) Corporate Office Monday through Friday, 8:00 am to 5:00 pm hours: (USA Pacific Time) EU Representative: Newport Medical Instruments Att. Robert Brink c/o Braun & Co. 19 Pasture Rd. Barton-on-Humber...
  • Page 11 2. MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Maintenance & Overhaul Intervals......2-1 General Warnings..........2-1 General Cautions ..........2-2 Parts Required / Tools Required ......2-2 Maintenance Procedures ........2-3 – Inlet Water Trap Filters & O-rings Assembly 2-3 – Exhalation Valve Adapter ......2-4 –...
  • Page 13: Maintenance & Overhaul Intervals

    GENERAL WARNINGS WARNING All servicing or repair of the e360 ventilator must be carried out off patient. Hazardous voltages are present inside the e360 ventilator. Use extreme caution if it is necessary to work inside the ventilator while it is connected to a power source.
  • Page 14: General Cautions

    MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE GENERAL CAUTIONS Caution 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 ventilator malfunction or damage.
  • Page 15: Maintenance Procedures

    SECTION 2 Overhaul Kit The Overhaul Kit (OVL360A) includes the following items: Part Number Quantity Description JFK100P JAR Filter Kit RRK1800P Regulator Rebuild Kit GRD1800P Cooling Fan Filter & Guard ADP2105M Exh. Valve Adapter PPT1805A Exh. Valve Dia & Poppet Assy ORG1200P O-Ring, Exhalation Flow Sensor DIA1800M...
  • Page 16: Exhalation Valve Adapter

    MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Remove and replace the inlet filter and O-ring. Reinstall the filter holder and reassemble the water trap assembly. Retaining Latch Adapter Lip Valve Adapter ADP2105M Exhalation Valve Adapter Figure 2-2 Exhalation Valve Adapter Replacement Access the Exhalation Valve Adapter by lifting the Retaining Latch and removing the Exhalation Valve and Exhalation Flow Sensor, see Figure 2-2 above.
  • Page 17: Exhalation Valve Diaphragm, Seal & O-Ring

    SECTION 2 Exhalation Valve Diaphragm, Seal & O-Ring Exh. Valve Nut Collar Exh. Valve Cap NUT1802M CAP2112M CAP1803M DIA1810M PPT1800M Diaphragm Poppet Assy PPT1801M PPT1805A SEL1800M SLD2110M ORG1200P SCR1830P Exh. Valve Body ORG2127P BDY2103M Figure 2-3 Diaphragm, Seal & O-Ring Replacement Unscrew the Exhalation Valve Nut Collar and lift off.
  • Page 18: Overhaul Procedures

    MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Outlet Retaining Screws Emergency Inhalation Relief Outlet Block Inhalation Diaphragm Emergency Adapter DIA1800M Valve Cap Figure 2-5 Emergency Relief Diaphragm Replacement Access the Inhalation Outlet Assembly by removing the Lower Right Front Panel, see Figure 2-4 above. Remove the Inhalation Outlet Assembly by removing the two retaining screws, see Figure 2-5 above.
  • Page 19: Air And Oxygen Inlet Regulator Rebuild

    SECTION 2 Air and Oxygen Inlet Regulator Rebuild Diaphragm Cover O-Ring Spring Slip Ring Figure 2-6 Inlet Regulator Rebuild To remove/install the Air and Oxygen Inlet Regulator, follow the procedures in Section 4 of this manual, “Removal of Servo Valves, Regulators, Inlet Block and Flow Sensor Block”.
  • Page 20: Exhalation Valve Diaphragm/Poppet Assembly

    MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Exhalation Valve Diaphragm/Poppet Assembly Refer to Drawing 2-3 Unscrew the Exhalation Valve Nut Collar and lift off. Then lift off 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.
  • Page 21: Emergency Relief Diaphragm

    SECTION 2 Emergency Relief Diaphragm To replace the Emergency Relief Diaphragm, follow the procedures given in the Preventive Maintenance at the beginning Emergency Intake Diaphragm of this section. Mixing Block Retaining Screws (2) Mixing Block Emergency Intake Valve Emergency Intake Valve Retaining Screws (2) Figure 2-8 Emergency Intake Diaphragm Replacement...
  • Page 22: Inhalation Outlet Check Valve

    Warning: Observe correct polarity when reconnecting battery connectors. Tubing The tubing inside the e360 ventilator does not need to be replaced at any predetermined time interval; however, Newport is aware that tubing may occasionally need replacing. During the overhaul procedure, carefully inspect all tubing for degradation, cracks, or...
  • Page 23: Software Upgrade Procedure

    Mode screen is displayed, see Figure 2-11. Connect USB Flash Drive (with latest software) to the USB port on the Back Panel of the e360 ventilator (see Figure 2-13 for USB port location). Press “Start Download” on touch screen (Figure 2-11). The e360 ventilator will sound a short beep.
  • Page 24 When software download is completed, ventilator will sound a the screen and flashing stops. Turn OFF the power of the e360 ventilator. Wait at least 10 seconds and turn the e360 ventilator power back ON. 10 Wait until “Ventilation Standby” screen appears.
  • Page 25 Turn OFF the power of the e360 ventilator. Connect medical grade air source to Air Inlet on the Back Panel of the e360 ventilator and make sure that medical grade air source can provide at least 30 psi and does not exceed more than 90 psi.
  • Page 26 17 Turn “OFF” the power of the e360 ventilator. 18 Press and hold “Accept” button and then turn “ON” the power of the e360 ventilator to enter into Software Download screen on the e360 ventilator shown in Figure 2-11. “Accept”...
  • Page 27 Sensor calibration, d9. Wait for 30 sec ~ 1 minute until “TSI Air flow:“ and “Exhale Flow:“ numbers start to increase gradually and the air flow is delivered from the e360 ventilator. It requires 6 ~ 10 minutes to complete Exhalation Flow Sensor calibration, see Figure 2-18).
  • Page 28 MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Y-Piece Breathing Circuit Figure 2-14 Patient Circuit Setup Figure 2-15 Ventilation Standby Screen 2-16 SER360 A1106...
  • Page 29 SECTION 2 Figure 2-16 Circuit Check Screen Figure 2-17 Technical Screen 2-17 SER360 A1106...
  • Page 30 MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Figure 2-18 Diagnostic Data Screen 2-18 SER360 A1106...
  • Page 31: Software Upgrade Form

    SECTION 2 NEWPORT e360 VENTILATOR SOFTWARE UPGRADE FORM COMPLETE FORM MUST BE FAXED TO NEWPORT REGULATORY AFFAIRS UPON COMPLETION OF UPGRADE. Fax completed form to: 1.714.427.0839 attention RA/QA Or email requested information to: regulatory@NewportNMI.com Facility Name: __________________________________________________________________ Facility Address: ________________________________________________________________...
  • Page 33 3. TROUBLESHOOTING GUIDE Troubleshooting Guide .......... 3-1 Device Alert Messages.......... 3-3 SER360 A1106...
  • Page 35 SECTION 3 TROUBLESHOOTING GUIDE Table 3-1 may provide guidance in determining the cause and possible corrective action for ventilator problems. Newport does not guarantee that the suggested corrective action will solve the problem. Contact Newport Technical Service Department for additional assistance.
  • Page 36 TROUBLESHOOTING GUIDE Problem Potential Cause Suggested Action Internal battery does not Defective battery or battery Replace internal battery or replace the charge. charging hardware. DC-DC power supply PCB. Loss of battery power. Battery missing, discharged or Recharge or replace battery. defective.
  • Page 37 SECTION 3 DEVICE ALERT MESSAGES Table 3-2 defines the Device Alert violations and messages that may be displayed in the message window. The first line in the message window displays the date and time of the error; the second line displays the error message. Table 3-2 Device Alert Messages Device Alert Violation...
  • Page 38 Power Failure Power Failure High DC power out of tolerance. Check +12 VDC, –12 VDC and +5 VDC. (The e360 may have been powered by internal battery until it was depleted and a Device Alert resulted.) SER360 A1106...
  • Page 39 4. COMPONENT REMOVAL & REPLACEMENT Removal of Key Components – Preparation ............ 4-1 – Tools Required ..........4-1 Exhalation Valve and Exhalation Flow Sensor ............4-2 Exhalation Flow Sensor Cable (outside) (CBL2123P) ............4-3 Top Cover (CVR2101M)........4-3 Front Panel Assembly (DSP2102A) ....4-4 Main Board (PCB2100A) ........
  • Page 40 Heater Assembly (HTR1200A) ......4-22 Exhalation Manifold (MNF2110A) ......4-23 Exhalation Flow Sensor Board (PCB2103P) ..4-24 Battery (BAT1800P) ..........4-25 AC to DC Power Supply (PWR2100P)....4-26 DC to DC Power Supply Board (PCB2101A) ............ 4-27 Sound Processor Board (PCB2106P) ....4-28 Single Board Computer (SBC2100P)....
  • Page 41: Removal Of Key Components

    Removal of Key Components Unless instructed otherwise, reinstall parts by reversing the disassembly procedure. Preparation Before performing any repair or service on the e360 ventilator do the following: Disconnect the power. Shut off or disconnect the air and oxygen gas supplies.
  • Page 42: Exhalation Valve And Exhalation Flow Sensor

    COMPONENT REMOVAL & REPLACEMENT Removal of Exhalation Valve and Exhalation Flow Sensor Caution: The Exhalation Flow Sensor is a precise yet delicate instrument. Take care when handling not to disturb the measuring wires. The life cycle of the sensor is limited and will depend on observance of safe handling precautions and the ability to calibrate the sensor.
  • Page 43: Exhalation Flow Sensor Cable (Outside) (Cbl2123P)

    Figure 4-2 Top Cover Refer to figure 4-2 and follow these steps: Rotate the e360 so the rear of the ventilator is facing you. Locate the 6 screws securing the cover to the e360 and remove. SER360 A1106...
  • Page 44: Front Panel Assembly (Dsp2102A)

    COMPONENT REMOVAL & REPLACEMENT Grab the handles on the sides of the e360 ventilator, pull the sides away from the chassis and slide the cover off of the e360 ventilator. To reinstall, reverse above steps 2 and 3. Removal and Replacement of Front Panel Assembly DSP2102A...
  • Page 45 SECTION 4 • 2 wire cable of CBL2112A from connection IR of SBC2100P. IR is a 5 pin connector located on the bottom of SBC2100P. After all above cables are removed, fully remove the front panel assembly and set on a stable surface. To reinstall, reverse above steps 2 and 3.
  • Page 46: Main Board (Pcb2100A)

    For ESD protection, place the main board in an ESD safe container. To reinstall, reverse above steps 2 and 3. Note: If the main board PCB2100A is replaced, the e360 ventilator will need sofware reloaded and D5, D1, D2, D9 and D4 calibrations performed.
  • Page 47: Display Board (Pcb2102A)

    SECTION 4 Place the main board support with main board in an ESD safe container. To reinstall, reverse above steps 2 through 5. Note: Cable CBL2102A connects from P308 on PCB2100A to the top Red LED. Cable CBL2125A connects from P309 on PCB2100A to the top Amber LED.
  • Page 48: Touch Screen Interface Board (Pcb2105P)

    Place the display board in an ESD safe container. To reinstall, reverse above steps 2 through 7. Note: If the Display Board PCB2102A is replaced, the e360 ventilator will need the software reloaded. Refer to Section 2 for Software Upgrade Procedure.
  • Page 49: Large Lcd Cable (Cbl2105A)

    SECTION 4 Removal and Replacement of Large LCD Cable CBL2105A 4 nuts, 2 each side securing LCD hous- ing BKT2104M to LCD housing CBL2105A front panel cover BKT2104M Double sided tape located under cable Ground wire and nut Cable restraint and nut Figure 4-8 CBL2105A Refer to figure 4-8 and follow these steps:...
  • Page 50 COMPONENT REMOVAL & REPLACEMENT Removal and Replacement of Front Panel Cover CVR2104M Remove BZL2105M CVR2104M Nut securing flat ribbon 8 screws ground cable Encoder knob is located on front of panel Figure 4-9 Front Panel Cover CVR2104M Refer to figure 4-9 and follow these steps: Perform above steps to remove the Display Board PCB2102A.
  • Page 51: Optical Encoder (Enc1800P)

    SECTION 4 Removal and Replacement of Optical Encoder ENC1800P Perform above steps for removal of the front panel cover CVR2104M. Using an 11mm wrench, remove the nut and washer securing the encoder to the front panel cover CVR2104M. To reinstall, reverse the above step 2. Note: When securing the encoder with the nut and washer, tighten the nut to 8 in/lbs of torque.
  • Page 52: Touch Screen (Pnl2105P)

    COMPONENT REMOVAL & REPLACEMENT Removal and Replacement of Touch Screen PNL2105P Affix tape 0.10” from the inside edge TAP1200P BZL2105M Figure 4-10 Touch Screen Panel PNL2105P Note: Removal of the touch screen PNL2105P will destroy the screen, do not remove unless you have a replacement touch screen PNL2105P.
  • Page 53: Pneumatics Panel Assembly (Svo2101A)

    SECTION 4 Removal and Replacement Pneumatics Panel Assembly SVO2101A Refer to figures 4-11, 4-12 and 4-13 and follow these steps: 4 screws, 2 each side secures PNL2102M Figure 4-11 Pneumatics Panel 6 screws, 3 on each side secures CVR2106M Figure 4-12 Pneumatics Cover 4-13 SER360 A1106...
  • Page 54 Remove the yellow tube and blue tube from the air and oxygen servo vales SVO2101P While supporting the pneumatics panel, slide the panel away from the e360 ventilator. To reinstall, support the pneumatics panel and align the air and oxygen flow sensors into the flow sensor manifold block, secure 2 screws on top for the pneumatics panel PNL2102M before releasing support.
  • Page 55: Sensor Block

    SECTION 4 Removal and Replacement of Servo Valves, Regulators, Inlet Blocks and Flow Sensor Block Inlet block BLK2115M PNL2102M Regulator REG1800P Servo Valve SVO2101P Flow sensor block BLK2101M Figure 4-14 Pneumatics Panel Assembly SVO2101A Refer to figure 4-14 and follow these steps: Perform above steps for removal of pneumatic panel assembly SVO2101A.
  • Page 56: Regulator And Solenoid Assembly Bkt2105A

    COMPONENT REMOVAL & REPLACEMENT Removal and Replacement of Regulator and Solenoid Assembly BKT2105A 2 screws, 1 each side securing Regulator and solenoid BKT2105A to e360 assembly BKT2105A Exhalation Servo Vavle VLV1806P Crossover solenoid Emergency Relief SOL1501P Solenoid SOL1501P Machine 1 Pressure...
  • Page 57: Inspiratory Flow Sensors

    SECTION 4 Remove 2 screws and washers securing BKT2105A to the e360 ventilator. To reinstall, reverse the above steps. Removal and Replacement of FTD2100P and FTD2101P Inspiratory Flow Sensors Cable CBL2116A Mixing block Air flow sensor Connected to J1 on...
  • Page 58: Main Flow Outlet Block Assembly (Blk2108A)

    Oxygen sensor cable CBL2109A Outlet block BLK2108A Remove 2 screws Figure 4-18 Outlet Block BLK2108A Refer to figure 4-17 and 4-18 and follow these steps: Remove the 2 screws securing DOR2112M to the front of the e360 ventilator. 4-18 SER360 A1106...
  • Page 59: Oxygen Sensor (R125P03-002)

    SECTION 4 Remove 2 screws securing BLK2108A to the e360 ventilator. Pull the BLK2108A away from the e360 ventilator and remove 2 tubes. To reinstall, reverse above steps 2 and 3. Removal and Replacement of Oxygen Sensor R125P03-002 Refer to figure 4-18 and 4-19 and follow these steps.
  • Page 60: Assembly

    P03-002. Remove 2 screws on top of mixing block BLK2107M. Remove both the mixing block and inhalation block from the e360 ventilator. Remove 2 screws and washers securing mixing block BLK2107M to inhalation outlet block BLK2117M and separate the two.
  • Page 61 Remove flat cable CBL2118A from J401 on PCB2104A. Remove oxygen sensor cable CBL2109A from J404 on PCB2104A. Remove air and oxygen flow sensor cables CBL2116A from J402 and J403 on PCB2104A Remove 4 screws and washers securing PCB2104A to the e360 ventilator. 4-21 SER360 A1106...
  • Page 62 COMPONENT REMOVAL & REPLACEMENT To reinstall, reverse above steps 2 through 6. Note: If the analog board PCB2104A is replaced, the e360 ventilator will need D5 calibration performed. Refer to Section 5 for the D5 calibration. Removal and Replacement of Heater Assembly HTR2100A...
  • Page 63 Removal and Replacement of Exhalation Manifold MNF2110A Refer to figures 4-23 and 4-24 and follow these steps: Turn the e360 ventilator so the bottom of the unit is facing upward, remove 3 screws securing the MNF2101A to the base of the e360 and the 1 screw and washer securing the bumper BMP2100P to the bottom of the e360 ventilator.
  • Page 64: Exhalation Manifold Mnf2110A

    COMPONENT REMOVAL & REPLACEMENT Exhalation valve drive line Machine 2 pressure line Figure 4-24 Removal of MNF2110A Removal and Replacement of Exhalation Flow Sensor Board PCB2103P Refer to figure 4-25 and follow these steps. Perform above steps for removal of Exhalation Manifold MNF2110A.
  • Page 65: Battery (Bat1800P)

    Perform steps for removal of Top Cover on Page 4-3. Remove the battery wires from the positive and negative terminals. Remove the screw securing the battery bracket to the e360 ventilator and life off bracket. Remove the battery by lifting up and out.
  • Page 66 Perform above steps for removal of the battery. Removal cables CBL2115A from connector TB1 and CBL2103A from connector TB2 on PWR2100P Remove 4 screws and washers securing PWR2100P to the e360 ventilator. Remove the PWR2100P. To reinstall, reverse above steps 2 through 4. 4-26...
  • Page 67 • CBL2108A from J106 on PCB2101P • CBL2111A from J101 on PCB2101P • CBL2119A from J102 on PCB2101P Remove 4 screws and washers securing PCB2101P to the e360 ventilator. To reinstall, reverse above steps 2 and 3. 4-27 SER360 A1106...
  • Page 68: Sound Processor Board (Pcb2106P)

    Perform above steps for removal of the battery. Remove flat ribbon cable from CN1 on PCB2106P Remove 2 screws and washers securing PCB2106P to the e360 ventilator Remove the board. To reinstall, reverse above steps 2 through 4 Removal and Replacement of Single Board Computer SBC2100P...
  • Page 69 SBC2100P when connecting the 6-pin connector on SBC2100P. Note: If the Single Board Computer SBC2100P is replaced, the e360 ventilator will need software reloaded. Refer to Section 2 for Software Upgrade Procedure. 4-29...
  • Page 71 Setup ..............5-2 Diagnostic Mode ..........5-3 – Entering Diagnostic Mode......5-3 Analog PCB Calibration ........5-4 e360 Pneumatics Calibration ......5-9 – Air Inlet Regulator ........5-9 – Oxygen Inlet Regulator ........ 5-11 – Exhalation Servo Regulator ......5-11 –...
  • Page 73: Calibration Procedures

    The purpose of these procedures is to provide instructions and acceptance/rejection criteria to calibrate the e360 Ventilator. This section describes how to use the e360 Ventilator’s Diagnostic Mode to calibrate the e360 ventilator. The Diagnostic Mode can also be used for troubleshooting (see Section 3 for more information on troubleshooting).
  • Page 74: Setup

    Section 4, “Removal of Top Cover”. Reconnect the AC power to the e360 ventilator. Connect both air and oxygen supply gas sources to the e360 ventilator, verify supply gas sources are at 50 ±2 psig. Prior to starting the calibration procedure, verify that all test equipment is in current calibration status.
  • Page 75: Diagnostic Mode

    SECTION 5 Diagnostic Mode Most of the calibrations on the e360 ventilator are performed in the Diagnostic Mode. The Diagnostic Mode enables you to perform Servo Valve Calibration, Exhalation Valve Calibration, and Regulator Calibration. Table 5-1 Diagnostic Mode Diagnostic Mode...
  • Page 76 Panel and “0” will be displayed in the “Flow/t Insp” window “d0” will be displayed in the “Trig” window on the Control when the e360 ventilator enters into the Diagnostics Mode. Press the button below the “Trig” window, then the display will start blinking.
  • Page 77 SECTION 5 11 As the setting of “Resp Rate” increases, the value of “Drive Pressure” will decrease after the “Accept” button is pressed. 12 As the setting of “Resp Rate” decreases, the value of “Drive Pressure” will increase after the “Accept” button is pressed. 13 When the setting of “Resp Rate”...
  • Page 78 CALIBRATION PROCEDURES 25 Remove the pressure and then connect the ORANGE tubing back to the bottom port of transducer XD107. 26 To calibrate the zero pressure offset of Machine 2 pressure transducer XD106, repeat steps 4 to 14, except for the following difference.
  • Page 79 Device Alert will occur when the pressure to XD105 is 20cmH2O higher than the pressure to XD106. Device Alert can be only cleared by turning OFF and ON the e360 ventilator. pressure transducer XD102, repeat steps 4 to 14, except To calibrate the zero pressure offset of Air Gas Supply for the following difference.
  • Page 80 CALIBRATION PROCEDURES c. In step 24, calibrate the value of “Oxygen Gas Supply” to 25.0 ± 0.1 psig. d. In step 25, connect BLUE tubing back to the top port of transducer XD103. 34 Turn OFF the power, and then disconnect the Air and O supplies and AC power.
  • Page 81: Air Inlet Regulator

    Supply Pneumatics Calibration NOTE: Before proceeding with the pneumatics calibration, the Analog PCB in the e360 ventilator must be previously calibrated. NOTE: To calibrate Air/Oxygen Inlet Regulators, and Safety Regulator, use Diagnostic Mode “d3”: Manual Flow Adjustment. Air Inlet Regulator Connect the Air and Oxygen gas supplies and AC power to the e360 ventilator.
  • Page 82 CALIBRATION PROCEDURES Press the button below the “Trig” window then the display will start blinking. While the display is blinking, turn the Adjustment Knob to change the setting from “d0” to “d3”. Then press the “Accept” button to acknowledge. The Message ID will change to “11”. Press the button “Select”...
  • Page 83: Oxygen Inlet Regulator

    SECTION 5 Table 5-4 Air Flow and Pressure Settings Flow Setting Air Inlet Pressure 3 L/min 15.0 to 16.0 psig 100 L/min 12.0 to 14.5 psig 180 L/min > 9.5 psig Oxygen Inlet Regulator While still in Diagnostic Mode “d3”, adjust F to 100% oxygen and adjust Flow to 3 L/min.
  • Page 84: Safety Regulator

    Safety Regulator While still in Diagnostics Mode “d3”, adjust Flow to 3 L/min. Connect a patient circuit to the e360 ventilator as shown in Figure 6-1. (Test lung is not needed) Disconnect the patient circuit from the Exhalation Valve, and connect it to the Y-piece of the patient circuit, which is to form a close loop.
  • Page 85: Oxygen Servo Valve

    Disconnect the patient circuit from the e360 ventilator. Press the “Manual Inflation” button to initiate Air Servo Valve calibration. The e360 ventilator will go through a calibration maneuver that slowly increases and then decreases flow twice. The value of “TSI Air Flow” displayed on LCD touch screen will slowly change as the delivered flow changes.
  • Page 86: Exhalation Flow Sensor

    Turn OFF the e360 ventilator. Standby” screen is displayed. Turn ON the e360 ventilator and wait until the “Ventilation Connect the patient circuit to the e360 ventilator as shown in Figure 6-1. Occlude the patient circuit at the Y-piece using a cap. A filter and test lung is not required for this calibration.
  • Page 87 SECTION 5 Table 5-6 Descriptions of Message ID D1: Air Servo Valve Calibration Meaning Hit Manual Inflation Button to Start Air Servo Valve Calibration Calibrating Air Servo Valve Air Servo Valve Calibration Completed Calibration Failed: Valve Leaks more than 50 cc D2: Oxygen Servo Valve Calibration Meaning Hit Manual Inflation Button to Start Oxygen Servo Valve Calibration...
  • Page 88 CALIBRATION PROCEDURES D9: Exhalation Flow Sensor Calibration Meaning Occlude the Patient Circuit and Hit Manual Inflation Button to Start Exhalation Flow Sensor Calibration Calibration Exhalation Flow Sensor Exhalation Flow Sensor Calibration Completed Exhalation Flow Sensor Failed: Sensor Bad Exhalation Flow Sensor Calibration Failed: No Flow Detected Note: Proximal pressure is the average pressure of Machine 1 and Machine 2 pressure 5-16 SER360 A1106...
  • Page 89 – Manual Inflation ..........6-11 – Inspiratory Tidal Volume ......6-11 – Expiratory Tidal Volume ......6-11 – Alarm Silence ..........6-12 – Loss of Power Alarm and Battery Operation ............6-12 e360 Operational Verification Test Record Sheet ..........6-13 SER360 A1106...
  • Page 91: Operational Verification Procedure

    SECTION 6 OPERATIONAL VERIFICATION PROCEDURE The Operational Verification Procedure ensures that the Newport e360 Ventilator is in proper operating condition. WARNING Do not use the e360 ventilator unless it passes the Operational Verification Procedure. Test Equipment • Electrical safety test (EST) analyzer •...
  • Page 92: Setup

    Set regulators to 50 psig. Make a copy of the e360 Test Record sheets provided at the end of this section. Check the appropriate box or record appropriate data on the record sheet after each test is performed.
  • Page 93: Current Leakage Test

    OVP record sheet. To pass, the measured current leakage must be ? 100 µA. OPERATIONAL CHECKS Ensure the e360 ventilator Control Panel is adjusted to the settings shown in Table 6-1. NOTE: Adjustments are made with the Touch-Turn-Accept method.
  • Page 94: Front Panel Led Check

    OFF position. Press down the “Accept” button located next to the Adjustment Knob. OFF then to the ON position. This puts the e360 ventilator into While pressing the “Accept” button, toggle the power switch Diagnostics Mode. Release the ”Accept“ button.
  • Page 95: Circuit Leak Test

    Remove test lung if present and occlude the end of the patient circuit Y-Piece using CAP100P. Power ON the e360 ventilator or press “Setup & Calibration” button on the Control Panel. Press the “Circuit Check“ button on the display and follow the screen instructions.
  • Page 96: F I O Test

    OPERATIONAL VERIFICATION PROCEDURE Set the air gas supply pressure to 50 psig, and clear the alarm. Repeat steps 1-3 for the oxygen gas source. Shut off both gas supplies. Verify that the audible alarm sounds, the amber LED on the top is solid on, the red LED on the top is flashing, and the message display reads Both Air/O2 Supply Loss.
  • Page 97 Note: “The flow reading measured by the calibration analyzer” mentioned in steps 7-9 shall be the actual analyzer measurement dividing by 89%. This is because the e360 ventilator automatically reduces the flow delivery by 11% of the set flow to compensate for using without a humidifier (BTPS compensation).
  • Page 98: Bias Flow

    OPERATIONAL VERIFICATION PROCEDURE Bias Flow Set the e360 ventilator to Volume Control SPONT by pressing “Volume Control“ button until Spont LED is lit, and then pressing “Accept” button to acknowledge. Set the calibration analyzer to air flow measurement. Verify that the calibration analyzer measures a flow rate of 2.5 to 3.5 L/min, record the reading.
  • Page 99: Pressure Control

    Set Pressure Support to 0 cmH O, and verify no pressure- supported breaths are delivered. Pressure Trigger Sensitivity Set Pressure Support to 10 cmH Set PEEP/CPAP to 7 cmH Set e360 Trig to P (pressure) and set to 1.0 cmH SER360 A1106...
  • Page 100: Peep/Cpap

    PEEP/CPAP PEEP to 3 cmH O. Set the calibration analyzer to PEEP Set the e360 ventilator to the standard test settings except for measurement. Verify that the value of PEEP displayed on Numeric touch screen, the pressure reading measured by the calibration PEEP/CPAP setting are within tolerance of ±...
  • Page 101: Manual Inflation

    SECTION 6 Manual Inflation Set the e360 ventilator to Volume Control SPONT. Press the “Manual Inflation” button. Verify that a manual inflation is delivered while the button is pressed. Inspiratory Tidal Volume Set the e360 ventilator to Volume Control A/CMV.
  • Page 102: Alarm Silence

    Press the “Alarm Silence” button again and verify the indicator turns off, and the audible alarm resumes. Return e360 ventilator to standard test setting. Press Reset button to clear alarm indicators. Check off on the record sheet.
  • Page 103 SECTION 6 e360 OVP TEST RECORD SHEET Hospital or Organization ______________________________________________________________ e360 Serial Number ___________________ Hour Meter ________ Software Rev. __________ Service Technician ________________________________________ Date __________________ Released by ____________________________________________ Test Equipment: ID No. Electrical Safety Tol. Value Test Calibration Analyzer Ground resistance <0.1?
  • Page 104 OPERATIONAL VERIFICATION PROCEDURE e360 OVP TEST RECORD SHEET (CONTINUED) Inspiratory Time (sec) Ptrig Sensitivity (cmH 2 O) Measured Tol. Actual Tol. Range Insp. Time Range 0.25 0.2 - 0.3 + 0 - 2 0.4 - 0.6 + 2 - 4...
  • Page 105 APPENDIX A: THEORY OF OPERATION Device Description ..........A-1 Breath Types ............A-2 Volume Control..........A-2 Pressure Control ..........A-2 Volume Target Pressure Control ....A-3 Modes of Ventilation ..........A-3 A/CMV ............A-3 SIMV ..............A-4 SPONT ............A-4 Spontaneous Breath Management in SIMV and SPONT Modes ..........
  • Page 107: Device Description

    (peak, plateau, mean airway, and baseline). The e360 ventilator has a built in oxygen analyzer that can be calibrated with a push of a button. During exhalation, the e360 ventilator uses a bias flow to flush...
  • Page 108: Breath Types

    The heated exhalation system features an active exhalation valve with a low exhaled flow resistance for rapid return of circuit pressure to baseline and decreased potential for auto-PEEP. Breath Types The e360 ventilator offers these breath types: • Volume Control •...
  • Page 109: Modes Of Ventilation

    If the patient doesn’t breathe or if the patient’s efforts don’t cause airway pressure or airway flow to reach the Trig threshold, the e360 Ventilator delivers the number of time triggered breaths each minute selected via the Respiratory Rate setting.
  • Page 110: Spontaneous Breath Management In Simv And Spont Modes

    Trig threshold, no spontaneous breathing assistance is provided. Spontaneous Breath Management In SIMV and SPONT Modes There are two forms of spontaneous breath assistance on the e360 ventilator: • Pressure Support • Volume Target Pressure Support...
  • Page 111 (SIMV and SPONT - Volume Control and Pressure Control breath types only) For patient spontaneous efforts that trigger the ventilator, e360 delivers breaths with a constant pressure in the breathing circuit at a pressure equal to PEEP/CPAP + Pressure Support, until the end of patient inspiration.
  • Page 112: Safety Features

    • Protection From Re-breathing Exhaled Gases In Case of Ventilator Shutdown The e360 Ventilator software allows the user to perform a pre-use leak, compliance and resistance tests of the patient breathing circuit, humidifier and filters. Other software based selections include: breathing circuit compliance compensation of flow/volume delivery and monitoring On or Off, circuit type in use (heated expiratory limb (high output), heated insp.
  • Page 113 APPENDIX A decreased potential for auto-PEEP. A filter is used between the expiratory limb of the breathing circuit and the expiratory (FROM PATIENT) port to prevent contaminants in the exhaled gas from entering the exhalation system. Protection From Over Pressurization In the case of a High Pressure alarm violation, Sustained High Baseline Pressure alarm violation with suspension of ventilation, Device Alert shutdown, Both Air/O...
  • Page 114: Description Of Functional Subsystems

    THEORY OF OPERATION Description of Functional Subsystems The e360 Ventilator includes these subsystems: • Inhalation system • Exhalation system • Electronics • Safety mechanisms Inhalation System The inhalation system supplies gas according to the user-selected breath delivery settings. Figure A-1 e360 Ventilator Inhalation System Supply gas enters the inlet filters (one for oxygen and one for air) at a pressure of 30 to 90 pounds per square inch gauge (psig).
  • Page 115 APPENDIX A regulator and servo valve, the servo valve calibration should be rerun when either component is replaced. Most of the gas pressure drops across the servo valves, and gas exiting the servo valves is close to patient pressure. Check valves downstream of the servo valves prevent cross- contamination from the ventilator to the gas supplies.
  • Page 116: Exhalation System

    Figure A-2 e360 Ventilator Exhalation System Because gas delivered to and exhaled from the patient is humidified to near 100% relative humidity, the expiratory block includes a heater to prevent condensate from forming as the exhaled gas passes through the exhalation system.
  • Page 117: Electronics

    A pressure transducer at the exhalation valve provides feedback that tells the exhalation solenoid to increase or decrease its output to achieve the correct drive pressure. The exhalation solenoid associates an approximate PEEP with an approximate drive pressure. In case of a circuit disconnect, these reference pressures help avoid supplying excess pressure in the circuit after reconnection.
  • Page 119 APPENDIX B: ORDERING & CONTACT INFORMATION Ordering Parts and Kits ........B-1 Contact Technical Support ........B-3 Return e360 for Repair.......... B-3 Submit a Product Complaint ........ B-4 SER360 A1106...
  • Page 121 APPENDIX B ORDERING PARTS AND KITS FROM CUSTOMER SERVICE This section lists field-replaceable parts kits for the e360 Ventilator. For more information about parts or ordering, contact Newport Customer Service: Telephone (voice mail): 800.451.3111, extension 282 (only in USA) 714.427.5811, extension 282 Fax: 714.427.0489...
  • Page 122 ORDERING & CONTACT INFORMATION Table B-1 e360 Ventilator Spare Parts List, cont. Description Part Number CABLE ASSY, SBC TO BACKPANEL VGA PORT CBL2104A CABLE ASSY, SBC TO TOUCH PANEL CONTROLLER CBL2112A CABLE ASSY, USB TO SBC CBL2114A CABLE, GROUND CBL2144M...
  • Page 123 For other returns: dial extension 282 to reach the Customer Service department. RETURN e360 FOR REPAIR Follow these steps to return your e360 Ventilator for repair: Obtain a returned goods authorization (RGA) number from Newport Technical Support at the numbers given above.
  • Page 124 RGA number is issued. To submit a “Product Complaint Report”, go to the Newport website WWW.VENTILATORS.COM and click on Customer Support / Complaint Report. Fill out the form com- pletely with as much detail as possible and submit. A Technical Support Team member will review your product complaint and con- tact you shortly to resolve any issues you may have.
  • Page 125 APPENDIX C: DIAGRAMS e360 System Electrical Block Diagram ....C-1 e360 System Pneumatic Diagram ......C-2 SER360 A1106...
  • Page 126 DIAGRAMS SER360 A1106...
  • Page 127 APPENDIX C SYSTEM ELECTRICAL BLOCK DIAGRAM SWD2100A SER360 A1106...
  • Page 128 DIAGRAMS SER360 A1106...
  • Page 129 APPENDIX C e360 PNEUMATIC DIAGRAM SPD2100A SER360 A1106...

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