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NEWPORT E-360 Ventilator Service Manual

1. 10 Electronics ss 11 SER360 1106 DEVICE DESCRIPTION SER360 A1106 APPENDIX A The e360 ventilator employs a dual servo gas delivery system one each for air and oxygen a servo controlled active exhalation valve and a combination control panel interface and touch screen interface graphics monitor GUI The electronically controlled inlet gas mixing system is superior to traditional pneumatic mixers that must exhaust gas from the system to consistently deliver precise oxygen concentrations The dual servos respond immediately to change the delivered when requested by the control system Approximately 60 minutes of operational backup power is available when the ventilator s internal battery is fully charged In addition the e360 ventilator has remote alarm external battery VGA and external alarm silence connections plus an RS232 interface to connect to central monitoring systems and USB port for uploading software When the e360 ventilator is turned on the Power On Self Test POST verifies the integrity of the software and hardware of the ventilator and the ventilator is in Standby until the user selects Start Ventilating During operation the ventilator performs regular pressure transducer calibrations and software tests to ensure accuracy of monitored and displayed data A user initiated Circuit Check performs a leak test of the breathing circuit system and measures circu
2. TEM 5 2 Diagnostic Mode 5 3 Entering Diagnostic 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 Safety Regulator 5 12 Air Servo Valve 5 12 Oxygen Servo 444 5 13 Exhalation Flow Sensor 5 14 Exhalation Servo Valve 5 14 Descriptions of Message ID 5 15 SER360 A1106 SECTION 5 CALIBRATION PROCEDURES Calibration Equipment SER360 A1106 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 WARNING An authorized Newport Medical Instruments factory trained service technician must perform all service and repairs on the e360 Ventilator WARNING Hazardous voltages are present inside the e360 ventilator D
3. 4 7 Touch Screen Interface Board PCB2105P 4 8 Large LCD Cable CBL2105A 4 9 Front Panel Cover CVR2104M 4 10 Optical Encoder ENC19800P 4 11 Alarm LEDS vox cR rna 4 11 LCD Display DSP2105P 4 11 Touch Screen 21 4 12 Pneumatics Panel Assembly SVO2101A 4 13 Servo Valves Regulators Inlet Block and Flow Sensor 4 15 Regulator and Solenoid Assembly gt aa 4 16 Inspiratory Flow Sensors 4 17 Main Flow Outlet Block Assembly 2 ata cr Eri 4 18 Oxygen Sensor R125P03 002 4 19 Inhalation Outlet Block and Mixing Bloc ASSembly eel 4 20 Analog Board 2104 4 21 Heater Assembly HTR1200A 4 22 Exhalation Manifold 2110 4 23 Exhalation Flow Sensor Board PCB2103P 4 24 Battery BAT1800P 4 25 AC to DC Power Supply PWR 2100P 4 26 DC to DC Power Supply Board 2
4. Pressure Support cmH 0 10 Variance Set Ppeak Measured Pressure Tol Range 1 Variance Inspiratory Tidal Volume mL Set VTI Measured Volume Tol Range 10 Variance 10 Variance Expiratory Tidal Volume mL Tol Range Volume Measured Tol Range 10 10 212 259 10 10 423 517 10 880 1030 10 SER360 1106 APPENDIX THEORY OF OPERATION Device Description A 1 Breath Types c cerdos A 2 Volume ubt e n Do da A 2 Pressure Control A 2 Volume Target Pressure Control A 3 Modes of Ventilation A 3 246 Deci Ves orna ab d E 3 OIA 4 4 Spontaneous Breath Management SIMV and SPONT Modes A 5 Safety A 6 Description of Functional Subsystems A 8 Inhalation 8 Exhalation System
5. aap 10 PATIEN SE SOLENOID PRESSURE OXYGEN REGULATED SER360 A1106 APPENDIX FoR fpr e 11 26 27 CONNECTIONS ROM E TUBE LOCATION PORT LOCATION PORT LENGTH COLOR icem evene 5 1 s we free free s me a s e 2 joe pesmconas owrervsousnoo frere 72 rosse u gt 3 oneen knee ws 3 jme ow 3 mx onen Romeo f o s pememnm _ 3 gen pem C RAEN SES F 22772777770 s exem e me e mum e _ 2 suco pero venom 2 moore 5 sewowsemowase 72 omnee ICT a eem s we recreoucen a 1 emne rexs 2 osse remus e 3 pemamowmwran 74 7 3 jme e360 PNEUMATIC DIAGRAM SPD2100A SER360 1106
6. or equivalent e Adult test lung LNG800P or adult test lung with RP20 airway resistor LNG600A or equivalent e Adjustable 0 60 psig dry clean regulated medical grade air and oxygen gas supplies e to occlude the patient circuit Y piece CAP100P or equivalent Caution The accuracy of all test equipment electronic or pneumatic used for verification or calibration procedures should be certified annually by a testing laboratory before use 6 1 OPERATIONAL VERIFICATION PROCEDURE SETUP Y Piece Breathing Circuit Figure 6 1 Test Setup 1 Connect reusable adult patient breathing circuit to the e360 ventilator to be tested Attach a test lung to the patient breathing circuit Y Piece 2 Connect the calibration analyzer with oxygen sensor between the main flow outlet and the patient breathing circuit 3 Connect regulated adjustable air and oxygen gas supplies to ventilator inlets on the back of the ventilator Set regulators to 50 psig 4 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 ELECTRICAL SAFETY CHECKS Ground Resistance Test 1 Connect the A C power cord to the EST analyzer 2 Connect the ground lead of the EST analyzer to the labeled equipotential connection on the back of the ventilator 3 Perform ground resistance check and record th
7. 2 8 Emergency Relief Diaphragm 2 9 Emergency Intake Diaphragm 2 9 Inhalation Outlet Check Valve 2 10 Internal Battery 2 10 Uis aie EE 2 10 Software Upgrade Procedure 2 11 General Information 2 2 11 Upgrade Procedure 2 11 Circuit Test amp 2 13 Software Upgrade Form 2 19 SER360 1106 SECTION 2 MAINTENANCE 4 OVERHAUL INTERVALS The Level Preventive Maintenance procedure should be performed once a year or every 5000 hours whichever comes first Perform the Level 2 Overhaul Procedure every 5 years or 25 000 hours whichever comes first 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 Disconnect electrical power air and oxygen sources before attempting any disassembly Failure to do so could result in injury to service personnel or equipment To maintain grounding integrity the e360 ventilator must be connected to a hospital grade receptacle when in use DANGER There is a risk of explosion i
8. XD106 Machine 2 0 00 2 0 05 Green XD105 Machine 1 0 00 gt 0 05 Clear XD102 Air Gas Supply 0 0 psig 0 1 Yellow XD103 2 Gas DD 0 0 psig 50 41 Table 5 3 Gain Calibration GAIN SETTING TRANSDUCER ID LCD DISPLAY PRESSURE TOLERANCE DESIGN ATION t Insp XD107 Drive Pressure Bottom Port 110 gt XD106 Machine 2 XD105 Machine 1 110 cmH2O Bottom Port Top Port 110 cmH2O Yellow Pneumatics Calibration Air Inlet Regulator SER360 A1106 Blue 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 1 Connect the Air and Oxygen gas supplies and AC power to the e360 ventilator 2 Turn ON the power to the e360 ventilator 3 Enter the Diagnostics Mode following the procedure Entering Diagnostics Mode in this Section 5 9 CALIBRATION PROCEDURES 4 Press the button below the Trig window then the display will start blinking 5 While the display is blinking turn the Adjustment Knob to change the setting from dO to d3 Then press the Accept button to acknowledge The Message ID will change to 117 6 Press the button Select above the Flow t Insp windo
9. cmH20 gt Pressure Trigger Sensitivity Pressure Support 10 cmHoO gt SER360 1106 SECTION 6 Set calibration analyzer to peak pressure measurement in cmH5O Set Pressure Limit to 10 cmH5O and t Insp to 3 0 seconds Verify that the value of Ppeak displayed on Numeric screen the peak pressure measured by the calibration analyzer and the Pressure Limit setting are within tolerance of 10 among each other Record the readings on the Test Record Repeat step with Pressure Limit setting of 20 cmH5O Repeat step 3 with Pressure Limit setting of 50 cmH5O Set the e360 ventilator to Pressure Control SPONT Set Trig to P pressure and adjust to 0 5 cmH5O Set Pressure Support to 10 cmH5O Squeeze the test lung to trigger a breath Verify that the value of Ppeak displayed on Numeric screen the peak pressure measured by the calibration analyzer and the Pressure Support setting are within tolerance of 10 among each other Record the readings on the Test Record Repeat step 4 with Pressure Support for setting of 20 cmH5O Set Pressure Support to 0 cmH5O and verify no pressure supported breaths are delivered Set Pressure Support to 10 cmH5O Set PEEP CPAP to 7 cmH5O Set e360 Trig to P pressure and set to 1 0 cmH5O 6 9 OPERATIONAL VERIFICATION PROCEDURE PEEP CPAP PEEP CPAP PEEP CPAP 6 10 Manually squeeze and slowly release the test lung to creat
10. CALIBRATION PROCEDURES Exhalation Flow Sensor d9 Exhalation Servo Valve d4 10 Turn OFF the e360 ventilator Turn ON the e360 ventilator and wait until the Ventilation Standby screen is displayed 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 Press CIRCUIT CHECK LCD touch screen to perform the circuit check Confirm that the circuit check passes Press SENSORS on LCD touch screen and press Flow Sensor to start Exhalation Flow Sensor calibration It may require performing several times in order to pass the Exhalation Flow Sensor calibration Turn OFF the e360 ventilator and turn ON while pressing and holding Accept button to enter Diagnostics Mode Set the e360 ventilator to Diagnostics Mode d9 With patient circuit occluded press Manual Inflation button to start Exhalation Flow Sensor calibration in Diagnostics Mode The Message ID will change to 63 Wait for several minutes to complete the calibration until the Message ID changes to 41 Set the e360 ventilator to Diagnostics Mode d4 With patient circuit occluded press the Manual Inflation button once The Message will change to 35 Press the Manual Inflation button again to start the calibration now the Message ID will change to 15 Wait for several
11. The target pressure of the first breath when no target pressure has been established is PEEP CPAP 5 e Protection From Over Pressurization 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 expiratory limb middle output or HME leak compensation On or Off set time and date and adjust for operation at the local altitude All modes of ventilation and breath types on the e360 Ventilator include a range of settings appropriate for adult or pediatric infant patients To maximize patient safety the Control Panel has an Accept Button that must be pressed to activate any setting changes This feature is to prevent accidental changes The e360 has settable alarm limits for high and low peak airway pressure high and low expiratory minute volume high respiratory rate circuit disconnect threshold and apnea The Low Minute Volume Alarm activates Back up Ventilation which increases respiratory rate in and SIMV and provides pressure controlled ventilation according safe basic settings in SPONT mode in order to increase ventilatio
12. 3 Remove 4 screws and washers securing PWR2100P to the e360 ventilator 4 Remove the PWR2100P 5 To reinstall reverse above steps 2 through 4 4 26 SER360 1106 SECTION 4 Removal and Replacement of DC to DC Power Supply PCB2101A CBL2103A at J104 2111 atJ101 2101 103 1 on PCB2106P Remove 4 screws 5 S CBL2108A at J106 CBL2119A at J102 Figure 4 28 Dc to DC power supply PCB2101P Refer to figure 4 28 and follow steps 1 Perform above steps for removal of battery BAT 1880P 2 Remove cables from the following locations e 2101 from J103 on PCB2101P CBL2103A from J104 on PCB2101P CBL2108A from J106 on PCB2101P CBL2111A from J101 on PCB2101P CBL2119A from J102 on PCB2101P 3 Remove 4 screws and washers securing PCB2101P to the e360 ventilator 4 reinstall reverse above steps 2 and 3 SER360 A1106 4 27 COMPONENT REMOVAL 4 REPLACEMENT Removal and Replacement of Sound Processor Board PCB2106P Refer to figure 4 28 and follow these steps 1 Perform above steps for removal of the battery 2 Remove flat ribbon cable from CN1 on PCB2106P 3 Remove 2 screws and washers securing PCB2106P to the e360 ventilator 4 Remove the board 5 To reinstall reverse above steps 2 through 4 Removal and Replacement of Single Board Computer SBC2100P Cable CBL2105A to LCD connector CBL2104A to VGA connector Cable CBL2108A to
13. 4 27 Sound Processor Board 2106 4 28 Single Board Computer SBC2100P 4 28 Removal of Key Components Preparation Tools Required SER360 A1106 SECTION 4 Unless instructed otherwise reinstall parts by reversing the disassembly procedure Before performing any repair or service on the e360 ventilator do the following 1 2 Disconnect the power Shut off or disconnect the air and oxygen gas supplies Put on an ESD wrist strap and perform procedures in an ESD safe environment 0 Philips Screw Driver 1 Philips Screw Driver 2 Philips Screw Driver 1 Flat Screw Driver 5 64 Hex Key 7 32 Nut Driver or Wrench 11 mm Nut Driver or Wrench Torque Wrench set for 8 inch pounds Anti Static Wrist Strap Anti Static Parts Bin WARNING avoid possibility of electric shock do not touch the power supply transformer when servicing the ventilator These instructions are intended for use only by a Newport Medical Instruments factory trained technician Do not perform any unauthorized modifications or repairs to the ventilator or its components Caution To avoid damaging equipment always use standard electrostatic discharge ESD precautions including an ESD wrist strap when servicing the ventilator Note If the Main Board Display Board or Single Board computer components are replaced the e360 software must be reloaded Follow the Software Upgrade Procedure i
14. NewportNMI com TechService 9 NewportNMI com INTRODUCTION Department Customer Service 282 extensions 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 amp Co 19 Pasture Rd Barton on Humber North Lincolnshire DN18 5 HN England tel 44 77 68 231311 Fax 44 1652 633399 SER360 A1106 2 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE Maintenance amp Overhaul 1 2 1 General 2 1 General Cautions 2 2 Parts Required Tools Required 2 2 Maintenance Procedures 2 3 nlet Water Trap Filters amp O rings Assembly 2 3 Exhalation Valve Adapter 2 4 Exhalation Valve Diaphragm Seal KORING ient a a 2 5 Emergency Relief Diaphragm 2 5 Overhaul Procedures 2 6 Inlet Water Trap Filters amp O rings Assembly 2 6 Air and Oxygen Inlet Regulator Rebuild 2 7 Exhalation Valve Adapter 2 7 Exhalation Valve Diaphragm Poppet ASSBITIDIV 2 8 Cooling Fan Filter 4 Guard
15. adjust to 100 oxygen and adjust Flow to 3 L min 2 Adjust the oxygen inlet regulator pressure to 15 5 0 5 psig 3 adjust the Oxygen Inlet Pressure Regulator refer to the above Air Inlet Regulator step 9 4 Adjust Flow as shown below and verify that the expected regulated pressure for each flow setting is within tolerance Table 5 5 Oxygen Flow and Pressure Settings Flow Setting Oxygen Inlet Pressure 3 L min 15 0 to 16 0 psig 100 L min 12 0 to 14 5 psig 180 L min gt 9 5 psig 5 Adjust Flow to 0 L min and FO to 21 after the calibration is completed Exhalation Servo Regulator 1 Take the ORANGE tubing from the Exhalation Servo Valve port IN and connect to a high pressure gauge see Figure 5 4 2 Usea flat head screw driver to adjust the Exhalation Servo Regulator which is located near the Exhalation Servo Valve between 15 0 and 15 5 psig 3 Reconnect the ORANGE tubing to the Exhalation Servo Valve port IN SER360 1106 5 11 CALIBRATION PROCEDURES Safety Regulator Air Servo Valve d1 5 12 Orange Tubing to Exh Servo Val Port IN Exh Servo Val Exh Servo Regulator Safety Regulator Figure 5 4 Exhalation Servo Safety Regulators 1 While still in Diagnostics Mode d3 adjust Flow to L min 2 Connect a patient circuit to the e360 ventilator as shown in Figure 6 1 Test lung is not needed 3 Disconnect the patient circuit from
16. e360 ventilator 8 reinstall reverse the above steps Removal and Replacement of FTD2100P and FTD2101P Inspiratory Flow Sensors Cable CBL2116A Connected to J1 on flow sensors Mixing block BLK2107M Air flow sensor FTD2100P Oxygen flow sensor FTD2101P Figure 4 16 Inspiratory Flow Sensors Refer to figure 4 16 and follows these steps 1 Perform steps above for removal of pneumatics panel assembly SVO2101A 2 Remove cable CBL2116A from connector J1 on the flow sensor 3 Remove the flow sensors from mixing block BLK2107M by pulling the flow sensor straight out of the mixing block 4 reinstall reverse steps 2 and 3 Note If either of the flow sensors are replaced calibrations D1 and or D2 will need to be performed SER360 A1106 4 17 COMPONENT REMOVAL 4 REPLACEMENT Removal and Replacement of Main Flow Outlet Block Assembly BLK2108A Door DOR2112M Figure 4 17 Door DOR2112M Oxygen sensor cable CBL2109A Outlet block BLK2108A Figure 4 18 Outlet Block BLK2108A Refer to figure 4 17 and 4 18 and follow these steps 1 Remove the 2 screws securing DOR2112M to the front of the e360 ventilator 4 18 SER360 A1106 SECTION 4 2 Remove 2 screws securing BLK2108A to the e360 ventilator 3 Pull the BLK2108A away from the e360 ventilator and remove 2 tubes 4 reinstall reverse above steps 2 and 3 Removal and Replacement of Oxygen Sensor R125P03 002 Refer to figure 4 18 and
17. 3 and follow these steps 1 Perform steps 1 and 2 for removal of top cover 2 Locate the four screws securing the front panel assembly to the chassis of the e360 ventilator and remove 3 Carefully pull forward and away the front panel assembly from the e360 ventilator chassis Locate and remove the following cables e 2101 from J2 on PCB2100A e CBL2118A from J13 PCB2100A e CBL2110A from J8 on PCB2100A e CBL2113A from J10 on PCB2100A e Air and oxygen servo valve cables from J705 and J706 on PCB2100A CBL2107A from J708 PCB2100A CBL2122 from J9 on PCB2100A CBL2105A from connection LCD1 on SBC2100P 3 wire cable of CBL2112A from connection TS1 of SBC2100P TS1 is a 6 pin connector located adjacent to the speaker SPK1 4 4 SER360 1106 2 wire cable of CBL2112A from connection IR of SECTION 4 SBC2100P IR is a 5 pin connector located on the bottom of SBC2100P 4 After all above cables are removed fully remove the front panel assembly and set on a stable surface 5 To reinstall reverse above steps 2 and 3 Note Cable CBL2112A splits to two connectors 5 pin connector with 2 wires and 6 pin connector with 3 wires Ensure the 3 wires face outside when connecting the 6 pin connector on SBC2100P Note There is a small hole adjacent to J9 on PCB2100A which is to polarize the connector Removal and Replacement of Main Board PCB2100A SER360 A1106 CBL2102A amp CBL2125A connected to P308 amp
18. 4 SER360 1106 Circuit Leak Test Loss of Gas Alarm SER360 A1106 SECTION 6 Poor Ventilation Standby vee Circuit Check 1 Attach complete breathing circuit 2 Occlude circuit Y piece Patient Setup 3 Presss Circuit Check button to begin Technical START VENTILATING Figure 6 3 Circuit Leak Test NOTE Circuit Check is available in Ventilation Standby only 1 Remove test lung if present and occlude the end of the patient circuit Y Piece using CAP100P 2 Power ON the e360 ventilator or press Setup amp Calibration button on the Control Panel 3 Press the Circuit Check button on the display and follow the screen instructions 4 After the test is completed verify that the message display window reads PASSED Check off the record sheet and reattach the test lung 5 exit Ventilation Standby condition press the START VENTILATING button on LCD touch screen 1 Lower the air gas supply pressure to 20 psig Verify that there is no Loss of Gas alarm 2 Lower the air gas supply pressure to 8 psig Verify that the audible alarm sounds the amber LED on the top is flashing and the message display reads Air Supply Loss 6 5 OPERATIONAL VERIFICATION PROCEDURE 3 Set the air gas supply pressure to 50 psig and clear the alarm 4 Repeat steps 1 3 for the oxygen gas source 5 Shut off both gas supplies Verify that the audible alarm sounds the amber LED on the t
19. 6 5 Loss of Gas Lr e dier ant 6 5 Tesi Diu 6 6 e Main BLOW 6 6 Bias 9 6 8 Inspiratory TIme 5 urne 6 8 Respiratory Rate 6 8 Pressure 2 2 2 2 2 6 9 Pressure Support 6 9 Pressure Trigger Sensitivity 6 9 atre roi edita ed edu ease 6 10 Manual Inflation 6 11 Inspiratory Tidal Volume 6 11 Expiratory Tidal Volume 6 11 Alarm Silence 6 12 Loss of Power Alarm and Battery eR e eade bei 6 12 e360 Operational Verification Test Sheet oco ed iso to vaporem 6 13 SER360 1106 SECTION 6 OPERATIONAL VERIFICATION PROCEDURE Test Equipment SER360 A1106 The Operational Verification Procedure ensures that the Newport e360 Ventilator is in proper operating condition WARNING not use the e360 ventilator unless it passes the Operational Verification Procedure e Electrical safety test EST analyzer Certified calibration analyzer manufactured by TSI Inc or equivalent e Oxygen Analyzer Newport reusable patient breathing circuit
20. Alert shutdown Both Supply Loss alarm shutdown or Power Off the exhalation valve opens to allow the patient to exhale The exhalation valve also opens any time breathing circuit pressure reaches 135 cmH5O With exception of the High Pressure alarm these same conditions cause the inspiratory emergency relief valve solenoid to be de energized which allows the circuit pressure to vent if it is above the relief valve cracking pressure of 4 cmH5O The relief valve also opens any time breathing circuit pressure reaches 140 cmH5O A bacteria filter is placed between the inspiratory limb and the inspiratory TO PATIENT port to prevent contaminants in the exhaled gas from entering the inspiratory manifold when the inspiratory emergency relief valve is de energized Protection From Re breathing Exhaled Gases In Case of Ventilator Shutdown In the case of a Sustained High Baseline Pressure Alarm violation Device Alert shutdown Both Supply Loss alarm violation or Power Off gas delivery to the patient will cease The inspiratory manifold and exhalation valve systems are designed to protect the patient from re breathing exhaled gas under this condition A mechanical emergency intake valve in the inspiratory manifold allows the patient to breathe room air into the breathing circuit The exhalation valve acts as a one way valve allowing the patient to exhale but not inhale This system provides fresh gas through the inspiratory limb an
21. Calibration Failed Proximal Pressure Low than Target Pressure 19 Exhalation Valve Calibration Failed Test Flow Less than 1L min D5 Analog Board Calibration ID Meaning 21 Hit Manual Inflation Button to Start Analog Board Calibration 25 Analog Board Calibration Enabled 26 Analog Board Calibration Disabled SER360 A1106 5 15 CALIBRATION PROCEDURES D9 Exhalation Flow Sensor Calibration ID Meaning 2 Occlude the Patient Circuit and Hit Manual Inflation Button to Start Exhalation Flow Sensor Calibration 63 Calibration Exhalation Flow Sensor 41 Exhalation Flow Sensor Calibration Completed 59 Exhalation Flow Sensor Failed Sensor Bad 60 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 1106 6 OPERATIONAL VERIFICATION PROCEDURE Operational Verification Procedure 6 1 Test Equipment c t leere 6 1 SetuP ot 6 2 Electrical Safety Checks 6 2 Ground Resistance test 6 2 Current Leakage test 6 3 Operational Checks 6 3 Front Panel LED Check 6 4 Circuit Leak 2 22
22. FROM PATIENT port to prevent contaminants in the exhaled gas from entering the exhalation system and contaminating the exhalation valve and flow sensor Another filter should be placed at the TO PATIENT port to prevent contamination of the inspiratory manifold when the emergency relief valve opens the case of a Device Alert alarm Both Air Os Supply Loss alarm or Sustained High Baseline Pressure alarm that is accompanied by a blockage of the exhalation valve 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 The e360 ventilator offers these breath types Volume Control e Pressure Control e Volume Target Pressure Control Volume Control Each Volume Control mandatory breath is delivered primarily according to the user selected Tidal Volume and Flow Inspiratory Time setting and is secondarily affected by Respiratory Rate PEEP CPAP Pause Sigh and Flow Wave pattern settings A square flow wave pattern delivers the set flow constantly until the set tidal volume is delivered A descending ramp flow wave pattern delivers the set flow initially and then decreases at a constant rate until 5096 of the initial flow is reached and then terminates when the set Tidal Volume has been delivered Pressure Control Each Pressure Control mandatory breath is delivered primarily according to the u
23. L min and VT Tidal Volume to 500 reattach the test lung NOTE Because the e360 ventilator automatically compensates for use with a humidifier by lowering the flow by 11 calibrated to BTPS the calibration analyzer flow reading will be 11 lower than the ventilator s set flow rate if the calibration analyzer is not BPTS compensated NOTE When EMBED Equation 3 peakl reading displayed on the Numeric screen is higher than expected flow it could be caused by the peak flow delivered in the very beginning of the inspiratory phase In this case select flow waveform in the Waves screen and then press Freeze button to read the actual flow value To adjust the scale of the waveform touch the flow axis on the screen turn the knob and then touch the flow axis again to accept when a proper scale is obtained 6 7 OPERATIONAL VERIFICATION PROCEDURE Bias Flow MODE Volume Pressure Control Control A CMV SIMV SPONT Inspiratory Time Pressure Limit cmHgO Select Flow t Insp Respiratory Rate Select Flow t Insp 0 25 Umi 6 Resp Rate 6 8 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 Keep the te
24. Mandatory Ventilation SIMV e Spontaneous SPONT Assist Control Mandatory Ventilation A CMV In all breaths delivered to the patient are mandatory breaths The user may choose to Pressure Control Volume Control or Volume Target Pressure Control the mandatory breaths In any case the breaths may be time ventilator triggered or patient triggered The Respiratory Rate setting determines the minimum number of time triggered or patient triggered mandatory breaths delivered each minute In other words the patient is guaranteed to receive this number of mandatory breaths per minute The Trig setting determines the airway pressure or airway flow threshold that the patient s effort must reach in order to trigger these and additional mandatory breaths 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 Available on specific models SER360 A1106 A 3 THEORY OPERATION Synchronized Intermittent Mandatory Ventilation SIMV In SIMV mandatory and spontaneous breaths may be delivered to the patient The user may choose to Pressure Control Volume Control or Volume Target Pressure Control the mandatory breaths Mandatory breaths may be time ventilator triggered or patient triggered In Volume or Pressure Control
25. anesthetics 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 Caution Use standard antistatic techniques when working inside the e360 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 equipment malfunction and damage Mains voltage must correspond to the voltage range selected on the power module of the e360 ventilator Always replace an open 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 equipment malfunction or damage NOTE Use the tools specified in the manual to perform specific Procedures The e360 ventilator comes with a two 2 year conditional warranty The warranty covers any defect or malfunction that occurs due to normal use The warranty does not cover any SER360 1106 FACTORY SERVICE SECTION 1 scheduled maintenance See the e360 Ventilator Operating Manual for the conditions of this warranty Federal Law in the United States requires traceability of this
26. button is pressed As the setting of Resp Rate decreases the value of Drive Pressure will decrease after the Accept button is pressed Repeat steps 19 to 23 to obtain drive pressure of 110 0 cmH5O 1 0 cmH5O then press Manual Inflation button to acknowledge The Message ID will change to 26 5 5 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 In step 4 remove GREEN tubing from transducer XD106 b In step 7 adjust the setting of t Insp to 2 c In step 14 calibrate the value of Machine 2 to 0 00 0 05 cmH5O 27 To calibrate the gain of Machine 2 pressure transducer XD106 repeat steps 15 to 25 except for the following difference step 16 adjust the setting of t Insp to 3 b In step 17 apply a pressure of 110 1 cmH5O to the bottom port of transducer XD106 c In step 25 connect GREEN tubing back to the bottom port of transducer XD106 28 To calibrate the zero pressure offset of Machine 1 pressure transducer XD105 repeat steps 4 to 14 except for the following difference a In step 4 remove CLEAR tubing from transducer XD105 b In step 7 adjust the setting of t Insp to 4 c step 14 calibrate the value of Machine 1 to 0 00 0 05
27. care to line up the sensor port to the notch in the cable connector Press together do not twist SER360 A1106 SECTION 4 Removal and Replacement of Exhalation Flow Sensor Cable outside CBL2123P 1 Perform above steps for removal of Exhalation Valve and Exhalation Flow Sensor 2 Remove the Exhalation Flow Sensor Cable outside CBL2123P from the Exhalation Manifold MNF2110A by pulling the collet of the cable connector 3 reinstall the cable to the Exhalation Manifold MNF2110A align the key on the connector with the notch of the female connector on the Exhalation Manifold MNF2110A Note The lock mechanism of the connector can be easily released by pulling the collet of the connector Do NOT disconnect the connector by pulling the wire Removal and Replacement of Top Cover CVR2101M SER360 A1106 Remove 6 screws 3 each side securing top cover Figure 4 2 Top Cover Refer to figure 4 2 and follow these steps 1 Rotate the e360 so the rear of the ventilator is facing you 2 Locate the 6 screws securing the cover to the e360 and remove 4 3 COMPONENT REMOVAL 4 REPLACEMENT 3 Grab the handles on the sides of the e360 ventilator pull the sides away from the chassis and slide the cover off of the e860 ventilator 4 reinstall reverse above steps 2 and 3 Removal and Replacement of Front Panel Assembly DSP2102A Remove 4 screws 2 each side Figure 4 3 Front Panel Assembly DSP2102A Refer to 4
28. certified annually by a testing laboratory before use i d ail j mi Figure 5 1 e360 Ventilator Connected to Gas Sources 5 2 Visually inspect e360 ventilator for cosmetic defects damage or missing items Before removing the Top Cover unplug the e360 ventilator from the AC power and gas sources Remove the 6 screws on the Back Panel that secures the Top Cover to the e360 ventilator Remove the Top Cover see 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 SER360 A1106 Diagnostic Mode Entering Diagnostic Mode PROCEDURES SER360 A1106 SECTION 5 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 To enter Diagnostic Mode use the following instructions 1 Confirm the e360 ventilator is OFF and connected to AC power Press and hold the Accept button and turn ON the power Release the Accept button when NMI Logo Screen is displayed
29. cmH5O 29 To calibrate the gain of Machine 1 pressure transducer XD105 repeat steps 15 to 25 except for the following difference step 16 adjust the setting of t Insp to 5 b In step 17 apply a pressure of 110 1 cmH5O to both the top port of transducer XD105 and the bottom port of transducer XD106 c In step 25 connect CLEAR tubing back to the top port of transducer XD105 and connect GREEN tubing back to the bottom port of transducer XD106 5 6 SER360 A1106 SECTION 5 Note If pressure is only applied to transducer XD105 during this calibration 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 30 To calibrate the zero pressure offset of Air Gas Supply pressure transducer XD102 repeat steps 4 to 14 except for the following difference In step 4 remove YELLOW tubing from transducer XD102 b In step 7 adjust the setting of t Insp to 6 c In step 14 calibrate the value of Air Gas Supply to 0 0 0 1 31 To calibrate the gain of Air Gas Supply pressure transducer XD102 repeat steps 15 to 25 except for the following difference a In step 16 adjust the setting of t Insp to 7 b In step 17 apply a pressure of 25psig to the top port of transducer XD102 c In step 24 calibrate the value of Air Gas Supply to 25 0 0 1 psig d In step
30. 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 Scheduled maintenance or repair services are available from the Newport Technical Service department See Appendix B for instructions on returning your ventilator for service Newport s annual price list includes current pricing for scheduled maintenance and labor rates To obtain a copy of the price list please contact your local Newport representative or contact our Customer Service department COPYRIGHT INFORMATION CONTACT INFORMATION SER360 A1106 Copyright 2006 Newport Medical Instruments Inc all rights reserved The Newport e360 Ventilator system is manufactured in accordance with Newport Medical Instruments Inc proprietary information and is covered by the following Patent 6 439 229 The information in this manual is the sole property of Newport Medical Instruments Inc and may not be duplicated without permission This manual may be revised or replaced by Newport Medical Instruments at any time and without notice 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 NewportNMI com www Ventilators com Email Customers
31. power connector Cable CBL2114A to USB connector Cable CBL2112A to touch screen connector Cable CBL2112A to touch screen connector Remove 4 screws and washers 1 in each corner of PCB2100P Figure 4 29 Single Board Computer SBC2100P Refer to figure 4 29 and follow these steps 1 Perform above steps for removal of battery 2 Remove cables from the following locations 4 28 SER360 A1106 SER360 1106 SECTION 4 CBL2104A from VGA connector PCB2100P CBL2105A from LCD connector on PCB2100P CBL2108A from Power connector on PCB2100P CBL2112A from Touch Screen connector 3 wires on PCB2100P e CBL2100P from Touch Screen connector 2 wires on PCB2100P e 2114 from USB connector PCB2100P 3 Remove 4 screws and washers securing PCB2100P to the e360 ventilator 4 Remove the PCB2100P 5 To reinstall reverse steps 2 through 4 Note Cable CBL2112A splits to two connectors 5 pin connector with 2 wires and 6 pin connector with 3 wires Ensure the 3 wires face toward the closest edge of the 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 5 CALIBRATION PROCEDURES Calibration Procedures 5 1 Calibration Equipment 5 1
32. second line displays the error message Table 3 2 Device Alert Messages Device Alert Violation Priority Definitions Violation Messages Level Control communications Monitor uP Failed The monitor processor does not respond to a failure request from the control processor The monitor processor is not running Control CPU failure Control CPU Failed The control processor on the main PCB is bad Control exception failure M Internal System i The control processor has detected an abnormal operation such as illegal instruction or division by zero that was generated by the control software Control RAM Failure Control RAM Failed High Random access memory that is used by the control processor on the main PCB is damaged Control ROM failure Control ROM High Read only memory that stores the code of the Failed control processor has an incorrect check sum Control task continuity Control Tasks High Software tasks of the control processor have failure Failed operated out of sequence Dual RAM failure Dual RAM Failed i Random access memory that is shared between the control and monitor processors is damaged Monitor communications Control uP Failed The control processor does not respond to a failure request from the Monitor processor The control processor is not running Monitor CPU failure Monitor CPU Failed The monitor processor on the main PCB is bad Monitor exception failure C Internal System The monitor processor has dete
33. the Exhalation Valve and connect it to the Y piece of the patient circuit which is to form a close loop 4 Tee in a low pressure gauge in the patient circuit 5 Use a flat head screw driver to adjust the Safety Regulator see Figure 5 4 to obtain 140 5 cm2HO of Machine 1 pressure displayed on LCD touch screen 6 Verify the reading of the pressure gauge is within 2 cmHaO of the value of Machine 1 pressure 7 Adjust Flow to L min after the calibration is completed Then press Manual Inflation button to disable manual flow adjustment The Message ID will change to 13 Caution Do not attempt to perform Air Servo Valve calibration unless instructed by NMI Representative or for one of the following conditions Replacement or readjustment of Air Inlet Regulator Replacement of Air Servo Valve Replacement of Analog Replacement of Main PCB SER360 1106 42 SER360 1106 SECTION 5 Caution Do not attempt to perform Air Servo Valve calibration unless the air gas supply is regulated to 50 2 psig and capable of supporting a minimum of 180 L min of constant flow Set the e360 ventilator to Diagnostics Mode d1 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 twic
34. 06 Emergency Relief Diaphragm Emergency Intake Diaphragm SER360 A1106 SECTION 2 To replace the Emergency Relief Diaphragm follow the procedures given in the Preventive Maintenance at the beginning 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 1 Remove Top Cover following procedure in Section 4 of this manual Removal of Top cover 2 Remove Pneumatics Panel following procedure in Section 4 of this Manual Removal of Pneumatics Panel Assembly 3 Remove Inspiratory Flow Sensors following procedure in Section 4 of this manual Removal of Inspiratory Flow Sensors 4 Remove two Emergency Intake Valve retaining screws see Figure 2 8 above 5 Remove the Emergency Intake Valve using Needle Nose Pliers 6 Replace the Emergency Intake Diaphragm VLV100P and reinstall assembly by reversing procedure above 2 9 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE Inhalation Outlet Check Valve Inhalation Outlet Check Valve Figure 2 9 Inhalation Outlet Check Valve 1 Remove the Mixing Block by removing the two retaining screws see Figure 2 8 2 Remove the Inhalation Adapter from the Inhalation Outlet Assembly see Figure 2 5 3 Insert finger and push out the Inhalation Outlet Check Valve see Figure 2 9 4 Replace the Inhalation Outlet Check Valve Diaphrag
35. 1 Perform above steps for removal of Front Panel Assembly DSP2102A Remove 2 screws securing the door DOR2112M to the e360 ventilator Remove 2 screws securing heater HTR2100A to the MNF2110A Exhalation Manifold Remove heater cables from power supply board PCB2101A connectors J107 and J108 Remove the heater HTR2100A To reinstall reverse above steps 2 through 5 SER360 A1106 SECTION 4 Removal Replacement of Exhalation Manifold MNF2110A Refer to figures 4 23 and 4 24 and follow these steps 1 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 2 Remove the exhalation valve drive line and the Machine 2 pressure line from the rear of the Exhalation Manifold MNF2110A see figure 4 22 3 Remove the MNF2110A from the e360 ventilator 4 Toreinstall reverse above steps 2 and 3 Bumper BMP2100P Remove 3 screws Figure 4 23 Location of 3 screws and bumper SER360 A1106 4 23 COMPONENT REMOVAL 4 REPLACEMENT Exhalation valve drive line Machine 2 pressure line 4 Figure 4 24 Removal of MNF2110A Removal and Replacement of Exhalation Flow Sensor Board PCB2103P 4 24 Refer to figure 4 25 and follow these steps Perform above steps for removal of Exhalation Manifold MNF2110A 1 3 4 Remove cable CBL2122A fro
36. 25 connect YELLOW tubing back to the top port of transducer XD102 32 To calibrate the zero pressure offset of Oxygen Gas Supply pressure transducer XD103 repeat steps 4 to 14 except for the following difference a In step 4 remove BLUE tubing from transducer XD103 b In step 7 adjust the setting of t Insp to 8 c In step 14 calibrate the value of Oxygen Gas Supply to 0 0 0 1 psig 33 To calibrate the gain of Oxygen Gas Supply pressure transducer XD103 repeat steps 15 to 25 except for the following difference a In step 16 adjust the setting of t Insp to 9 b In step 17 apply a pressure of 25psig to the top port of transducer XD101 SER360 1106 5 7 CALIBRATION PROCEDURES In step 24 calibrate the value of Oxygen Gas Supply to 25 0 0 1 psig 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 gas supplies and AC power a E E d my 0 89 5 m 1516 NES IN B a 3 p OB nn 8 P Metu Ri LB Figure 5 2 Analog PCB 5 8 SER360 1106 SECTION 5 Table 5 2 Zero Offset Calibration ZERO SETTING TRANSDUCER ID LCD DISPLAY t Insp PRESSURE TOLERANCE TUBE COLOR XD107 Drive Pressure 3 00 cmH2O 0 05 Orange
37. 4 19 and follow these steps 1 Remove the Oxygen Sensor cable CBL2109A from the Oxygen Sensor R125P03 002 by unscrewing the connector on the cable 2 Remove the Oxygen Sensor by unscrewing the Oxygen Sensor counterclockwise 3 Toreinstall reverse above steps 1 and 2 Note If the Oxygen Sensor is installed too tightly to be removed place a Newport reusable circuit on the oxygen sensor to obtain better friction while unscrewing the Oxygen Sensor Figure 4 19 Use circuit to loosen Oxygen Senor SER360 1106 4 19 COMPONENT REMOVAL 4 REPLACEMENT Removal and Replacement of Inhalation Outlet Block and Mixing Block Assembly Remove 4 screws Inhalation outlet block Mixing block and washers A BLK2117M BLK2107M Figure 4 20 Inhalation Outlet block and mixing block Refer to figure 4 20 and follow these steps 1 Perform above steps for removal of Oxygen Sensor R125 002 2 Remove 2 screws on top of mixing block 2107 3 Remove both the mixing block and inhalation block from the e360 ventilator 4 Remove 2 screws and washers securing mixing block BLK2107M to inhalation outlet block BLK2117M and separate the two 5 To reinstall reverse above steps 2 through 5 4 20 SER360 A1106 SECTION 4 Removal and Replacement of Analog Board PCB2104A SER360 A1106 Flat cable CBL2118A Oxygen sensor cable CBL2109A Blue tube XD103 Green tube XD106 Orange tube E XD107 0 Clea
38. 7 Press Regional Settings button on LCD touch screen see Figure 2 17 Press Altitude button on LCD touch screen ft _ m setting will start flashing While the numbers are flashing rotate the Encoder Adjustment Knob to change the Altitude level to where this instruction is going to be performed For example if the location is at the sea level then set Altitude setting to 0 0 Press Accept button to set the new Altitude setting and flashing will stop Wait for 15 20 seconds Turn OFF the power of the e360 ventilator 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 button can be released once the ventilator sounds a short beep Press Start Diagnostics button on LCD touch screen and the Diagnostic Data screen will appear as shown in Figure 2 18 Press Trig Button on the Control Panel Rotate the Encoder Adjustment Knob to change value in display window to d9 and press Accept button Occlude the breathing circuit from the y piece using a CAP Do not use test lung SER360 1106 SECTION 2 22 Press Manual Inflation button to start Exhalation Flow 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 fro
39. A WO N Wait for few minutes until the Software Download Diagnostics Mode Screen is displayed see Figure 2 11 5 Press Start Diagnostics on the LCD touch screen see Figure 2 11 After short beeps Diagnostic Data Screen will be displayed Most calibrations rely on the Analog PCB being accurately calibrated first The Analog PCB has five 5 Transducers and each one must be calibrated according to the procedure in this Section After the Analog PCB has been properly calibrated proceed with the rest of the calibrations To perform the calibrations successfully it is very important that the air and oxygen gas supply are regulated to 50 2 psig and that 5 3 CALIBRATION PROCEDURES Analog PCB Calibration d5 5 4 the supply is capable of supporting a minimum of 180 L min of constant flow Attach the patient circuit to the e360 ventilator NOTE Observe ESD precautions throughout the following procedures for Analog PCB and Pneumatics Calibrations To locate the transducers on the Analog PCB see Figure 5 2 below 1 10 dO will be displayed in the Trig window on the Control Panel and 0 will be displayed in the Flow t Insp window when the e360 ventilator enters into the Diagnostics Mode 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 dO to 45 Then press the Accept but
40. BL2104A 5232 TOUCH PANEL va EXTERNAL EL MAAR CBL2114A USB USB SINGLE BOARD COMPUTER SBC2100P Tad BACK PANEL CBL2120A SBC AUDIO BOARD Coes 2108 SER360 1106 APPENDIX 02 FLOW FLOW SENSOR SENSOR ANALOG PCB PCB2104A CBL2116A CBL2118A CBL2116A oS CBL2109A a OXYGEN SENSOR CHASSIS CONNECTOR CBL2122A ASSY BL2113A CBL2107A SOLENOID CBL2101A SUPPLY CBL2103A 41 POWER ENTRY MODULE CBL2144M CBL2119A FAN POWER gt SWITCH 1 CBL2111A CBL2124P EXHALATION PCB CBL2124P EXHALATION FLOW SENSOR ADULT DC DC ASSY PCB2101A J107 J108 O a SYSTEM ELECTRICAL BLOCK DIAGRAM SWD2100A SER360 A1106 C 1 DIAGRAMS e560 PNEUMATIC DIAGRAM E E EXHALATION SYSTEM g 4 EXHALATION MANIFOLD L DRIVE PRESSURE SENSOR mmm FROM EXHALATION ae Nal A REZERO VALVE mi MACHINE 2 MUFFLER MACHINE PRESSURE 2 SENSORS 1 INHALATION SYSTEM Or 3 OUT 2 EXHALATION 7 AN REGULATOR 211 MACHINE PRESSURE 1 SENSOR A REZERO VALVE MACHINE 1
41. Drive e Software Upgrade Instructions e NMI Reusable Patient Circuit PBC340A or equivalent Cap to plug end of patient circuit CAP100P or equivalent Note Follow this procedure to reload software after performing a Main Board Display Board or Single Board Computer component replacement 1 Confirm the e360 ventilator is OFF and connect AC power cord to the AC wall outlet see Figure 2 13 for Power Entry Module location 2 Press and hold the Accept button and turn ON the power 3 Release the Accept button when NMI Logo Screen 15 displayed 4 Wait for few minutes until the Software Download Diagnostics Mode screen is displayed see Figure 2 11 5 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 6 Press Start Download on touch screen Figure 2 11 The e360 ventilator will sound a short beep Touch Selection to Begin message on screen will change to a flashing message downloading Wait 15 20 minutes for software download to complete MAINTENANCE OVERHAUL 8 SOFTWARE UPGRADE 2 12 10 11 12 13 14 15 16 Start Download Start Diagnostics Figure 2 11 Software Download Diagnostics Mode Screen When software download is completed ventilator will sound a short beep Download Complete message will appear on the screen and flashing stops Turn OFF the power of the e360 ve
42. INFORMATION Table B 1 e360 Ventilator Spare Parts List cont B 2 SER360 A1106 APPENDIX Table B 1 e360 Ventilator Spare Parts List cont CONTACT TECHNICAL SUPPORT Contact Newport Medical Instruments Technical Support using one of the contact information numbers below Phone 800 451 3111 extension 500 US only 714 427 5811 extension 500 Fax 714 427 0572 Technical Service Dept Email TechService NewportNMI com For maintenance warranty or non warranty repairs dial extension 500 to reach the Technical Service department If you need emergent technical support after business hours please call Technical Support and leave your name phone number and detailed message in the voice mail Our Technical Support Team members will be paged and return your call shortly 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 1 Obtain a returned goods authorization RGA number from Newport Technical Support at the numbers given above The RGA number helps to identify your repair and avoid service delays SER360 A1106 B 3 ORDERING amp CONTACT INFORMATION 2 Unless requested to do otherwise remove all accessories from the ventilator except the inlet water traps Do not send accessories to Newport 3 Package the ventilator in the original packing material if available If the original packing
43. NG GUIDE Troubleshooting Guide 3 1 Device Alert 5 3 3 SER360 A1106 TROUBLESHOOTING GUIDE Problem Fail Circuit Check Flow Sensor Error Bad Ventilator cannot achieve or maintain correct tidal volume plateau pressure or baseline pressure Pressure Bar graph does not show pressure rise SER360 A1106 SECTION 3 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 Table 3 1 Troubleshooting Guide Leak from patient circuit Leak from exhalation section Leak from inhalation section Leak from tubing connection inside the ventilator Defective exhalation flow sensor Defective exhalation flow sensor cables outside and inside Defective cable from exhalation sensor board to main board Defective exhalation sensor board Pressure relief valve regulator failure Crossover solenoid valve solenoid PCB failure Machine zero solenoid solenoid PCB valve failure Machine zero solenoid solenoid PCB valve failure Analog board malfunction Potential Cause Suggested Action Inspect patient circuit Disassemble exhalation valve to inspect exhalation valve diaphragm and seal Inspe
44. Newport Medical Instruments Inc NEWPORT 2360 VENTILATOR Service Manual SER360 Rev A 11 06 NEWPORT mW 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 SER360 1106 TABLE CONTENTS Section INTRODUCTION Section 2 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE Section 3 TROUBLESHOOTING GUIDE Section 4 COMPONENT REMOVAL amp REPLACEMENT Section 5 CALIBRATION PROCEDURES Section 6 OPERATIONAL VERIFICATION PROCEDURE Section 7 CLEANING and MAINTENANCE Appendix THEORY OF OPERATION Appendix ORDERING amp CONTACT INFORMATION Appendix EF TM MCN DIAGRAMS SER360 1106 1 INTRODUCTION IitFOgl ule Of asco DA A Me a tu area 1 1 1 1 General 1 1 General Cautions 1 2 Warranty 1 2 Factory Serice etes Dot el Rr brin Ud 1 3 Copyright Information 222 1 3 Contact Information 2 1 3 INTRODUCTION DEFINITIONS GENERAL WARNINGS SER360 A1106 SECTION 1 It is ver
45. P309 on PCB2100A Figure 4 4 Main Board PCB2100A Refer to figure 4 4 and follow these steps Remove 4 screws and washers CBL2106 connected To J4 on PCB2100A LCD cable CBL2105A Cables CBL2112A to SBC2100P 1 Perform steps above for removal of Front Panel Assembly DSP2102A 2 Remove cable CBL2106A from J4 on PCB2100A 3 Remove cable CBL2102A from P308 and CBL2125A from P309 on PCB2100A 4 Remove 4 screws and washers securing main board to the main board support 4 5 COMPONENT REMOVAL 4 REPLACEMENT 5 For ESD protection place the main board in an ESD safe container 6 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 Note Refer to Section 2 for Software Upgrade Procedure Refer to Section 5 for all the other calibrations Removal and Replacement of Main Board Support CVR2103M 4 6 CBL2102A and CLB2125A Remove 4 screws 2 each side CVR2103M CBL2106 connected Main board to J4 on PCB2100A PCB2100A Figure 4 5 Main Board Support CVR2103M Refer to figure 4 5 and follow these steps 1 Perform steps above for removal of Front Panel Assembly DSP2102A Remove cable CBL2106A from J4 on PCB2100A Remove the cables CBL2125A and CBL2102A from the top LEDs Remove Qty 4 screws and washers securing the main board support to the front panel
46. agm Adapter DiA1800M Emergency Valve Cap Figure 2 5 Emergency Relief Diaphragm Replacement 1 Access the Inhalation Outlet Assembly by removing the Lower Right Front Panel see Figure 2 4 above 2 Remove the Inhalation Outlet Assembly by removing the two retaining screws see Figure 2 5 above 3 Remove 4 screws from Emergency Valve Cap to expose the Emergency Relief Valve 4 Insert finger and pull the Emergency Relief Diaphragm DIA1800M out of Inhalation Outlet Block 5 Replace the Emergency Relief Diaphragm 6 To reinstall components and assembly reverse the above procedure OVERHAUL PROCEDURES WARNING Disconnect electrical power air and oxygen sources before attempting any disassembly Inlet Water Trap Filter and O ring Assembly To replace the Inlet Filter and O ring assemblies follow the procedures given in the Preventive Maintenance at the beginning of this section 2 6 SER360 A1106 SECTION 2 Air Oxygen Inlet Regulator Rebuild Exhalation Valve Adapter SER360 A1106 Cover 2 Diaphragm 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 NOTE Inlet Regulators must be outside of the Ventilator for dis assembly and re assembly To install the Air and Oxygen Inlet Regulators Rebuild Kits refer to Figure 2 6 an
47. ases its resistance The flow sensor adjusts power to keep wire temperature constant and the power required is directly proportional to the flow across the wire Each flow sensor is factory calibrated for air or oxygen Air and oxygen then enter the mixing chamber where they are combined The blended gas then exits to the patient circuit through the inspiratory manifold The inspiratory manifold also includes the emergency intake valve and the emergency relief valve These components are described above in item 4 Safety Features The oxygen sensor is mounted directly to the inspiratory manifold where it can monitor the delivered F O and compare it to the set FOV Because the oxygen sensor is sensitive to changes in atmospheric pressure and temperature the ventilator calibrates the oxygen sensor each time the Oo min button is activated and any time the monitored FjOo is gt 07 from the set value Ventilator software assigns an 5 of 1 0 to the voltage read during calibration The user may also initiate a calibration from a menu on the GUI During exhalation the inhalation system supplies a bias flow of 3 L min through the patient circuit to flush exhaled CO and stabilize temperature humidity and baseline pressure When either Leak Compensation or Non Invasive is turned On the ventilator provides leak compensation by increasing flow above bias flow to maintain end expiratory flow near 3 liters per minute in the expiratory
48. assembly Carefully lift up on the main board support and feed the cables CBL2105A CBL2106A and CBL2112A through the cut out on the main board support SER360 A1106 SECTION 4 6 Place the main board support with main board an ESD safe container 7 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 Removal and Replacement of Display Board PCB2102A SER360 A1106 Remove 9 screws PCB2102A Encoder cable and J209 Figure 4 6 Display Board PCB2102A CBL2112A PCB2105P 2 screws secure 4 pin ribbon cable PCB2105P Figure 4 7 Touch Screen Board PCB2105P Refer to figures 4 6 and 4 7 and follow these steps 4 7 COMPONENT REMOVAL 4 REPLACEMENT 8 9 Perform steps above for removal of Main Board Support Remove the 4 pin ribbon cable from header H2 on the touch screen interface board PCB2105P Remove cable CBL2112A from header H1 on the touch screen interface board PCB2105P Remove Qty 9 screws and washers securing the PCB2102A to the chassis of the DSP2102A Carefully lifting up on the display board from the lower left corner near the encoder locate and remove the cable of the encoder from J209 on the PCB2102A Remove the lamp cable of LCD DSP2105P from JP203 on PCB2102A Push on the tab and remove front panel membrane cable from JP202 on PCB2102A Place th
49. ct exhalation valve adapter Tighten inhalation flow outlet Tighten oxygen sensor Inspect emergency relief diaphragm Inspect pneumatic tubing inside the ven tilator Inspect TSI air oxygen flow sensors assembly Clean or replace emergency intake diaphragm Inspect rubber seal between inhalation outlet block and mixer block Replace exhalation flow sensor Replace exhalation flow sensor cables outside and inside Replace cable from exhalation sensor board to main board Replace the exhalation sensor board Perform the Operational Verification Procedure to diagnose the problem Replace any parts that may be defective Replace solenoid PCB and Analog PCB 3 1 TROUBLESHOOTING GUIDE Potential Cause Suggested Action Problem Internal battery does not charge Loss of battery power Low supply gas alarm No flow or low flow from inspiratory port during inspiratory phase of a mandatory breath Ventilator cannot cycle audible alarm on and error message displayed in message window Zero monitored exhaled flow Monitored values for exhaled flows or volumes differ from settings Monitored values differ from setting No audible alarm Defective battery or battery charging hardware Battery missing discharged or defective Defective battery hardware Supply pressure is not within specified range 30 90 psig Inlet regulator failure or servo valve failure Based on erro
50. cted abnormal operation such as illegal instruction or division by zero that was generated by the monitor software Monitor RAM failure Monitor RAM i Random access memory that is used by the Failed monitor processor on the main PCB is damaged SER360 A1106 3 3 TROUBLESHOOTING GUIDE Device Alert Violation Priority Definitions Violation Messages Level Monitor ROM failure Monitor ROM Read only memory that stores the code of the Failed monitor processor has an incorrect checksum Monitor task continuity Mon Task Failed Software tasks of the monitor processor have failure operated out of sequence 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 3 4 SER360 A1106 SER360 1106 4 amp REPLACEMENT Removal of Key Components EN 4 1 Tools Required enero sett 4 1 Exhalation Valve and Exhalation Flow eee T 4 2 Exhalation Flow Sensor Cable outside 4 3 Cover 2101 4 3 Front Panel Assembly 05 2102 4 4 Main Board 2100 4 5 Main Board Support CVR2103M 4 6 Display Board 2102
51. d an easy route for exhalation through the exhalation valve in the case of ventilator shutdown If the exhalation valve is blocked when the ventilator shuts down the patient will exhale through the inspiratory emergency relief valve when pressure in the circuit reaches the cracking pressure of 4 20 SER360 1106 7 THEORY OF OPERATION Description of Functional Subsystems The e360 Ventilator includes these subsystems Inhalation system Exhalation system e Electronics Safety mechanisms Inhalation System The inhalation system supplies gas according to the user selected breath delivery settings oum oA REGULATOR MACHINE PRESSURE 1 SENSOR I 1 1 I i A vave g 1 3 WET 5 T r Kae 1 r1 PATIENT A BLOCK rai EN REGULATOR Figure A 1 e360 Ventilator Inhalation System Supply gas enters the inlet filters
52. d do the following 1 Unscrew the brass cover from the regulator no tool should be needed and remove the spring diaphragm diaphragm washer seat with O ring small spring and ball see Figure 2 6 2 Replace the used parts reversing the disassembly with the parts from the Regulator Rebuild Kit P N RRK1800P NOTE The Regulator must be in a vertical position in order to reassemble the Kit components 3 Install the Regulator brass cover hand tight and ensure all components are aligned NOTE This procedure is the same for both the air and the oxygen regulators To replace the Exhalation Valve Adapter follow the procedures given in the Preventive Maintenance at the beginning of this section 2 7 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE Exhalation Valve Diaphragm Poppet Assembly Refer to Drawing 2 3 1 Unscrew the Exhalation Valve Nut Collar and lift off Then lift off the Exhalation Valve Cap and Diaphragm Poppet Assembly 2 Replace complete Diaphragm Poppet Assembly p n 1805 3 Reverse step 1 to reassemble the Diaphragm Poppet Assembly Exhalation Valve Cap and Exhalation Valve Nut Collar 4 Locate and replace O ring ORG1200P inside the Exhalation Valve see Figure 2 3 Cooling Fan Filter amp Guard Cooling Fan Filter amp Guard Figure 2 7 Filter and Guard Assembly Replacement Replace the Cooling Fan Filter and Guard Assembly GRD1800P see Figure 2 7 2 8 SER360 11
53. e The value of TSI Air Flow displayed on LCD touch screen will slowly change as the delivered flow changes Wait for several minutes to complete the calibration until the Message ID changes to 6 Note If the Message ID shows 7 during this calibration the Air Servo Valve needs to be replaced Caution Do not attempt to perform Oxygen Servo Valve calibration unless instructed by a NMI Representative or for one of the following conditions Replacement or readjustment of Oxygen Inlet Regulator Replacement of Oxygen Servo Valve Replacement of Analog PCB Replacement of Main PCB Caution Do not attempt to perform Oxygen Servo Valve calibration unless the oxygen gas supply is regulated to 50 2 psig and capable of supporting a minimum of 180 L min of constant flow Set the e360 ventilator to Diagnostics Mode d2 Disconnect the patient circuit from the e360 ventilator Press the Manual Inflation button to initiate Oxygen Servo Valve calibration The e360 ventilator will go through a calibration maneuver that slowly increases and then decreases flow twice The value of TSI O5 Flow displayed LCD touch screen will slowly change as the delivered flow changes Wait for several minutes to complete the calibration until the Message ID changes to 10 Note If the Message ID shows 7 during this calibration the Oxygen Servo Valve needs to be replaced 5 13
54. e dip in the pressure bar graph Verify that the dip equals the P Trig setting when a pressure support breath is triggered Repeat step 4 with setting of 3 20 Set Pressure Support to 0 cmH5O Leave the test lung connected and proceed to the next test Set the e360 ventilator to the standard test settings except for PEEP to cmH5O Set the calibration analyzer to PEEP measurement Verify that the value of PEEP displayed on Numeric touch screen the pressure reading measured by the calibration analyzer the pressure bar graph on the Control Panel and the PEEP CPAP setting are within tolerance of x 1 among each other Record readings on the e360 Test Record Repeat step 2 with PEEP setting of 10 cmH5O Set Low Paw alarm to 20 cmH5O and repeat step 2 with PEEP setting of 20 cmH5O NOTE Allow three to four breaths at each setting for pressure to stabilize 5 Set the PEEP to 0 cmH5O and set Low Paw alarm to 10 cmH5O 6 Remove the test lung SER360 1106 Manual Inflation MODE Volume Pressure Control Control A CMV SPONT Non Invasive Manual Inflation Tidal Volume 200 lt 999 mL 1 00 3 00 1 Expiratory Tidal Volume SER360 A1106 SECTION 6 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 Set the e360 ventilato
55. e 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 Removal and Replacement of Touch Screen Interface Board PCB2105P Refer to figure 4 7 above and follow these steps 1 2 4 8 Perform steps above for removal of Display Board PCB2102A Locate and remove 2 screws washers and nuts securing the PCB2105P to the display board To reinstall reverse step 2 SER360 A1106 SECTION 4 Removal and Replacement of Large LCD Cable CBL2105A SER360 A1106 4 nuts 2 each side securing LCD hous ing BKT2104M to LCD housing CBL2105A front panel cover Double sided tape located under cable BKT2104M Cable restraint and nut C Figure 4 8 CBL2105A Refer to figure 4 8 and follow these steps 1 2 Perform steps above to remove Display Board PCB2102A Using 7 32 nut driver remove the nut securing the ground wire of CBL2105A to the LCD housing BKT2104M Using a 7 32 nut driver remove the nut securing the cable restraint for CBL2105A to the LCD housing BKT2104M Gently lift the cable away from the LCD housing releasing it from the double sided tape Pull cable CBL2105A away from connector CN1 on the rear of the LCD display To reinstall the CBL2105A carefully align the cable connector with CN1 on the LCD di
56. e results on the OVP record sheet To pass the ventilator ground resistance must be 0 1 6 2 SER360 A1106 Current Leakage test OPERATIONAL CHECKS SER360 A1106 SECTION 6 1 Power the e360 ventilator 2 Perform the current leakage check and record the result on the OVP record sheet To pass the measured current leakage must be 100 pA 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 Table 6 1 Standard Test Setting Volume Control Mode 30 Tidal Volume 500 mL een NOTE Pressure readings should be to either cmH5O 6 3 OPERATIONAL VERIFICATION PROCEDURE Front Panel LED Check Encoder Adjustment Knob Manual Inflation N w gas O E Figure 6 2 Front Panel Controls amp Indicators 1 Toggle the power switch located on the back of the e360 ventilator to the OFF position 2 Press down the Accept button located next to the Adjustment Knob 3 While pressing the Accept button toggle the power switch OFF then to the ON position This puts the e360 ventilator into Diagnostics Mode Release the Accept button 4 Verify that all the Control Panel display lights are lit except for the Alarm Lamp on top of the ventilator 6
57. e securing a BKT2105A to e360 Exhalation Servo VLV1806P Emergency Relief Solenoid SOL1501P Machine 1 Pressure Rezero Solenoid SOL1501P Machine 2 Pressure Rezero Solenoid SOL1501P Figure 4 15 Regulator and Solenoid Assembly BKT2105A Refer to figure 4 15 and the System Pneumatic Diagram in Appendix C and follow these steps 1 Perform steps above for removal of Pneumatics Panel Assembly SVO2101A Remove the yellow tubing from the Air Inlet Block BLK2115M and remove the blue tubing from the Oxygen Inlet Block BLK2115M Refer to Fig 4 14 Remove the clear tubing from the top port of the pressure transducer XD105 machine 1 pressure on the analog board PCB2104A and remove the clear tubing from the exhaust port of the rezero solenoid SOL1501P for machine pressure 1 Remove the green tubing from the bottom port of the pressure transducer XD106 machine 2 pressure on the analog board PCB2104A and remove the green tubing from the exhaust port of the rezero solenoid SOL1501P for machine pressure 2 Remove the blue tubing one end of which is connected to the Exhalation Servo Valve VLV1806P from the other end which is connected to a tee connector Remove the green tubing one end of which is connected to the IN port of the Emergency Relief Solenoid SOL1501P from the other end which is connected to a cross tee connector SER360 A1106 SECTION 4 7 Remove 2 screws washers securing BKT2105A to the
58. enance Kit PMK360A includes the following items Part Number Quantity Description JFK100P 2 JAR Filter Kit ADP2105M Exhalation Valve Adapter DIA1800M Emergency Relief Diaphragm SEL1800M Exhalation Valve Seal ORG1200P O Ring Exhalation Flow Sensor DIA1810M Exhalation Valve Diaphragm 2 2 SER360 A1106 SECTION 2 Overhaul The Overhaul Kit OVL360A includes the following items JFK100P 2 JAR Filter Kit RRK1800P Regulator Rebuild Kit VLV2100M Inhalation Outlet Check Valve Diaphram BAT1800P Internal Battery MAINTENANCE PROCEDURES WARNING Disconnect electrical power air and oxygen sources before attempting any disassembly Inlet Water Trap Filters amp O ring Assembly Figure 2 1 Inlet Water Trap Filter Replacement 1 Unscrew the collection bowl from the inlet water trap 2 Unscrew the filter holder SER360 A1106 2 3 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE 3 Remove and replace the inlet filter and O ring 4 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 1 Access the Exhalation Valve Adapter by lifting the Retaining Latch and removing the Exhalation Valve and Exhalation Flow Sensor see Figure 2 2 above 2 To remove the silicon Exhalation Valve Adapter use your finger to grasp the Adapter and pull it
59. f the e360 ventilator is used in the presence of flammable anesthetics Before returning to patient use the e360 ventilator must pass the Operational Verification Procedure All service repairs of the e360 ventilator must be performed by a service technician authorized and trained by Newport Medical Instruments To prevent damage from ESD and possible failure of the e360 ventilator use standard anti static techniques when working inside the e360 ventilator handling circuit boards or other electronic components SER360 A1106 2 1 MAINTENANCE OVERHAUL 8 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 Mains voltage must correspond to the voltage range specified on the e360 ventilator Power Entry Module Always replace fuses with those of correct type and rating Keep all liquids away from the e360 ventilator Liquids in the e360 ventilator can cause malfunction or damage Always use standard antistatic techniques when working inside the e360 ventilator or handling any electronic parts TOOLS REQUIRED NOTE Use the tools specified in the manual to perform specific procedures Large Phillips screwdriver e Medium Phillips screwdriver e Needle Nose pliers PARTS REQUIRED Preventive Maintenance Kit The Preventive Maint
60. flow sensor The maximum leak compensation level available when Leak Compensation is turned On varies for each Patient Category as follows Ped Infant 8 L min Adult 15 L min Maximum leak compensation supplied by the Non Invasive function is 25 L min Transducers monitor pressure in the inspiratory manifold and expiratory system A transducer re zero solenoid maintains an accurate zero point for the pressure transducers by opening periodically to note the voltage that equals atmospheric zero pressure A 9 Exhalation System The exhalation system measures the flows and volumes of gas exhaled from the patient circuit measures pressure and controls the exhalation valve to manage pressure in the breathing circuit and allow patient exhalation EXHALATION MANIFOLD REZERO VALVE MACHINE 2 MACHINE PRESSURE 2 SENSORS 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 The heater heats the expiratory block and flow sensor to prevent condensation The exhalation flow sensor includes a hot wire sensor and a temperature compensation wire By measuring the temperature exchange for the hot wire in the flow sensor the ventilator calculates the flow of the exhaled gas The exhalation flo
61. g support Reverse steps 2 through 7 SER360 1106 SECTION 4 Removal and Replacement of Servo Valves Regulators Inlet Blocks and Flow Sensor Block SER360 A1106 Inlet block BLK2115M Figure 4 14 Pneumatics Panel Assembly SVO2101A Refer to figure 4 14 and follow these steps 1 Perform above steps for removal of pneumatic panel assembly SVO2101A Note To replace servo valves regulators inlet blocks or the flow sensor block all screws securing listed components need to be removed 2 Remove 4 screws 2 each securing the air and oxygen inlet blocks to PNL2102M 3 Remove 8 screws 4 each securing the air and oxygen servo valves to PNL2102M 4 Remove 2 screws securing the flow sensor block to PNL2102M 5 Lift all parts away from the panel PNL2102M at the same time then disassemble each component as needed 6 To reassemble reverse steps 2 through 5 Ensure the servo vales and regulators are aligned during reassembly Note If replacing either of the servo valves or regulators calibrations D1 D2 and calibration of the regulators will need to be performed Refer to Section 5 for D1 D2 and regulator calibration 4 15 COMPONENT REMOVAL 4 REPLACEMENT Removal and Replacement of Regulator and Solenoid Assembly BKT2105A 4 16 Regulator and solenoid assembly BKT2105A Crossover solenoid SOL1501P Safety Regulator REG1802P Exhalation Servo Regulator REG1701P 2 screws 1 each sid
62. he calibration analyzer and the Tidal Volume setting are within tolerance of 10 Record readings on the Test Record Set Tidal Volume to 1 00 L Verify that the value of VTE displayed on Numeric screen is between 840 mL 1 03 L and verify that the tidal volume reading measured by the calibration analyzer and the Tidal Volume setting are within tolerance of 10 Record readings on the Test Record Create an alarm condition by changing the settings and wait for the alarm to sound Press the Alarm Silence button and verify the indicator lights up and the audible alarm stops 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 Loss of Power Alarm and Battery Operation 6 12 1 2 Disconnect the power cord from the AC power source Verify that the messages AC Power Loss and Battery Back Up are displayed in the message window Verify that the audible alarm sounds the Power Fail indicator flashes and the Internal Battery indicator lights Verify that at least 3 bars of the charge bar graph are lit Reconnect the power cord to the AC power source SER360 1106 e360 OVP TEST RECORD SHEET Hospital or Organization SECTION 6 e360 Serial Number Hour Meter Software Rev Service Technician Released by Test Equip
63. ilator If there are no patient efforts or if the patient efforts fail to cause enough airway pressure or airway flow change to meet the set Trig threshold no spontaneous breathing assistance is provided Spontaneous Breath Management In SIMV and SPONT Modes 4 There two forms of spontaneous breath assistance on the e360 ventilator Pressure Support Volume Target Pressure Support SER360 A1106 SER360 1106 APPENDIX In Volume Control and Pressure Control SIMV spontaneous breaths with Pressure Support are available to the patient In Volume Target Pressure Control SIMV spontaneous breaths are Volume Target Pressure Support breaths In SPONT when Volume or Pressure Control breath type is selected spontaneous breaths with Pressure Support are available In SPONT Volume Target Pressure Control breath type Volume Target is selected in Advanced Data Set on GUI all spontaneous efforts are assisted by Volume Target Pressure Support Pressure Support 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 The breaths are delivered according to the user selected settings for Pressure Support Slope Rise Expiratory Threshold and PEEP CPAP The maximum inspiratory time is 2 seco
64. isconnect electrical power air and oxygen sources before attempting any disassembly Failure to do so could result in injury to service personnel or damage to equipment NOTE To prevent damage from ESD and possible failure of the e360 ventilator ALWAYS use standard anti static practices when working inside the e360 ventilator handling circuit boards or handling any other electronic components Verify that all test equipment is in current calibration status To calibrate the e360 Ventilator you will need the following e NMI Reusable Breathing Circuit PBC340A or equivalent Cap to plug the end of the breathing circuit CAP100P or equivalent e Clean dry regulated medical air and oxygen supplies at 50 2 psig NOTE To perform the calibration procedures correctly the gas supply pressure must be regulated to 50 2 psig The gas supplies can support a minimum constant flow of 180L min e Power Source of 100 240VAC 50 60 Hz High Pressure Gauge for reading from 0 60 psig or equivalent e Low Pressure Gauge for reading from 0 200 cmH5O or equivalent Calibrated pressure syringe NMI tool TOL1952P or equivalent 5 1 CALIBRATION PROCEDURES SETUP 1 4 inch Open ended Wrench 5 16 inch Open ended Wrench e Medium size flat head screw driver Caution The accuracy of all test equipment electronic or pneumatic used for verification or calibration procedures should be
65. it compliance and resistance User initiated sensor calibration tests allow for calibration of the and Exhalation Flow Sensors All breath types and modes include a range of ventilation and alarm settings appropriate for adult or pediatric infant patients The e360 ventilator has settable alarm limits for high and low airway pressure high and low expiratory minute ventilation back up ventilation high respiratory rate disconnect threshold and apnea There are built in alarms limits for Oo monitoring low baseline pressure high baseline pressure sustained high baseline pressure gas supply failure device alert and power switchover The e360 ventilator monitors and displays the power source volumes peak flows breath timing parameters ratio respiratory rate and inspiratory time delivered oxygen concentration and patient pressures 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 exhaled CO and stabilize temperature humidity and baseline pressure in the patient breathing circuit A stable baseline pressure between breaths helps to minimize auto triggering A 1 THEORY OPERATION Breath Types A 2 The exhalation system is heated to prevent moist exhaled gas from condensing in the exhalation pathway A bacteria filter should be used at the
66. ly the value of Drive Pressure cannot be increased In this case first increase the setting of Resp Rate to a high value and then decrease it Always press Accept button when the adjustment of the Resp Rate setting is made Repeat steps 8 to 13 to obtain drive pressure of 3 00 cmH5O 0 05cmH5O then press Manual Inflation button to acknowledge The Message ID will change to 26 NOTE Steps 15 to 25 are to calibrate the gain of the Exhalation drive pressure transducer XD107 Press the button below Flow t Insp window then the display will start blinking While the display is blinking turn the Adjustment Knob to set the value of t Insp to 1 and then press the Accept button to acknowledge Use a pressure syringe to apply a pressure of 110 1 20 to the bottom port of transducer XD107 Tee in a pressure gauge 0 to 200 cmH50 to insure accurate pressure delivery Press the Manual Inflation button to start the gain calibration The Message ID will change to 25 Press the button below the Resp Rate window then the display will start blinking While the display is blinking turn the Adjustment Knob to change the setting to any value then press the Accept button After the Accept button is pressed the value of Drive Pressure displayed on the LCD touch Screen will change As the setting of Resp Rate increases the value of Drive Pressure will increase after the Accept
67. m VLV2100M 5 Toreinstall components and assembly reverse above procedure Internal Battery To remove install the Internal battery follow the procedures in Section 4 of this manual Removal of Internal Battery Caution To avoid discharging battery voltage do not allow any metal object including tools to touch battery connectors 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 2 10 SER360 A1106 Upon Completion SECTION 2 brittleness If the tubing indicates any of those symptoms replace as necessary If tubing needs to be replaced please contact Customer Service and order the e360 Tube Replacement Kit Refer to the e860 System Pneumatic Diagram SPD2100A located in Appendix C to cut each tube to length and replace the worn tubing in the e360 ventilator After overhaul is completed perform a complete electronic and pneumatic calibration as outlined in Section 5 of this manual and the Operation Verification Procedure as provided in Section 6 e360 SOFTWARE UPGRADE PROCEDURE GENERAL INFORMATION UPGRADE PROCEDURE SER360 A1106 The following items are required for software upgrade Latest Software on USB Flash
68. m K1 and CBL2124P from K5 on PCB2103P Remove 2 screws and washers securing PCB2103P to the Exhalation Manifold MNF2110A Remove PCB2103P To reinstall reverse above steps 1 through 4 Note There is a small hole adjacent to K1 on PCB2103P which is to polarize the connector SER360 A1106 SECTION 4 CBL2124P connected to K5 on PCB2103P CBL2122A connected to K1 on PCB2103P Polarization hole for K1 on PCB2103P Figure 4 25 Exhalation Flow Sensor Board PCB2103A Removal and Replacement of Battery BAT1800P SER360 A1106 Positive terminal Negative terminal Remove screw Red wire Black wire Figure 4 26 Battery removal BAT1800P Refer to Figure 4 26 and perform these steps 1 Perform steps for removal of Top Cover on Page 4 3 2 Remove the battery wires from the positive and negative terminals 3 Remove the screw securing the battery bracket to the e360 ventilator and life off bracket 4 Remove the battery by lifting up and out 5 To reinstall reverse steps 2 through 4 4 25 COMPONENT REMOVAL 4 REPLACEMENT Removal and Replacement of AC DC Power Supply PWR2100P Cable CBL2115 Remove 4 screws Cable CBL2103 connected to TB1 and washers connected to TB2 Figure 4 27 AC DC Power Supply PWR2100P Refer to figure 4 27 and follows these steps 1 Perform above steps for removal of the battery 2 Removal cables CBL2115A from connector TB1 and CBL2103A from connector TB2 on PWR2100P
69. m the e360 ventilator It requires 6 10 minutes to complete Exhalation Flow Sensor calibration see Figure 2 18 23 When flow delivered from the e360 ventilator stops and Message ID number changes to 41 then the Exhalation Flow Sensor calibration is successfully completed see Figure 2 18 24 Turn OFF the power of the e360 ventilator 25 Disconnect medical grade air source from Air Inlet on the Back Panel of the e360 ventilator 26 Disconnect AC power cord from AC wall outlet 27 Upon completion of the installation of software upgrade you must complete the attached Newport e360 Ventilator Software Update Form with serial numbers part numbers and signatures and return it to Newport Regulatory Department via Fax at 1 714 427 0839 If you have any questions please contact Newport Technical Service Department Tel 1 714 427 5811 ext 500 Fax 1 714 427 0572 Email TechService NewportNMI com Inlet Air Inlet USB Connection Cooling Fan Filter Power Entry Module Figure 2 13 Back Panel of e360 Ventilator SER360 1106 2 15 MAINTENANCE OVERHAUL 8 SOFTWARE UPGRADE 2 16 iF Circuit Check 1 Attach complete breathing circuit 2 Occlude circuit Y piece 3 Presss Circui
70. material is not available call the Customer Service department to order a replacement box Package parts or accessories if requested for safe shipping original packing materials are not required SUBMIT A PRODUCT COMPLAINT B 4 If your ventilator is not functioning properly malfunctions or a part of your ventilator is defective a Product Complaint Report is required before any warranty replacement is authorized and or a 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 If you would like to request an RGA number for other returns or offer a product improvement suggestion you can also use the Product Complaint Report SER360 1106 SER360 1106 APPENDIX DIAGRAMS e360 System Electrical Block Diagram 1 e360 System Pneumatic Diagram C 2 DIAGRAMS LED RED CBL2102A CBL2125A MEMBRANE 9 CBL2106A REMOTE ALARM J4 MAIN F 1 8 J705 J10 CBL2105A OXYGEN AIR SERVOID SERVOID VALVE VALVE 1 CBL2112A VGA CBL2110A RS232 IR PWR C
71. ment Calibration Analyzer Oxygen Analyzer Electrical Safety Analyzer Test Inspiratory time Date Electrical Safety Tol Test Ground resistance lt 0 1 Max leakage current lt 100 Set Displayed Measured Tol Range 02 F02 Main Flow L min 21 Measured Flow 89 Tol Range Respiratory Rate 1 Variance Pressure Control 1 Variance Pressure Support Ptrig sensitivity PEEP CAP Manual Inflation Insp Tidal Volume 4 Variance 5 Variance Measured Flow 89 Tol Range Exp Tidal volume 1 Variance Alarm Silence Loss of power battery operation E p p SER360 1106 1 1 Variance 0 50 4 80 5 et i Bias Flow L min 5 Bias Flow Tol Rang 3 2 5 3 5 6 13 OPERATIONAL VERIFICATION PROCEDURE 360 OVP TEST RECORD SHEET CONTINUED Inspiratory Time sec Ptrig Sensitivity cmH 20 Set Measured Insp Time Actual Tol Range 0 25 0 5 Respirat ory Rate b min 20 Set ftot Measured Resp Rate PEEP Measured Tol Range Pressure Variance 1 Variance 1 Variance Pressure Control cmH 0 Set Ppeak Measured 1 Variance Tol Range 10 10
72. minutes to complete the calibration until the Message ID changes to 20 SER360 1106 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 Calibrating Oxygen Servo Valve 10 Oxygen Servo Valve Calibration Completed 7 Calibration Failed Valve Leaks more than 50 cc D3 Manual Flow Adjustment ID Meaning 11 Hit Manual Inflation Button to Enable Manual Flow Adjustment 12 Adjust Flow Setting 13 Manual Flow Adjustment Disabled D4 E xhalation Valve Calibration ID Meaning 14 Hit Manual Inflation Button to Enable Exhalation Valve Calibration 35 Occlude the Patient Circuit and Hit Manual Inflation Button Again to Start Exhalation Valve Calibration 15 Calibrating Exhalation Valve 20 Exhalation Valve Calibration Completed 16 Exhalation Valve Calibration Failed Proximal Pressure Less than 1 2 when Exhalation Valve Closed 17 Exhalation Valve Calibration Failed Proximal Pressure High than 1 2 when Exhalation Valve Opened 18 Exhalation Valve
73. n Section 2 to load software Contact Newport Technical Service if you need a software kit 4 1 COMPONENT REMOVAL 4 REPLACEMENT Removal of Exhalation Valve and Exhalation Flow Sensor 4 2 To disconnect cable CBL2123P from Exh Manifold MNF2110A pull the collet of the cable straight out To disconnect cable CBL2123P from Exh Flow Sensor FLS2101P pull the connector straight up 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 Always make sure that the flow sensor is completely dry before installation Figure 4 1 Exhalation Valve and Exhalation Flow Sensor Refer to figure 4 1 and follow these steps 1 Open the Front Panel Door on the lower left front of the ventilator to expose Exhalation Valve EXH2105A and Flow Sensor FLS2101P Remove the Exhalation Valve EXH2105A by releasing the retaining latch Disconnect the Flow Sensor Cable CBL2123P from the plastic body of the Flow Sensor FLS2101P by pulling cable straight up Do not twist With a twisting motion pull the plastic Flow Sensor FLS2101P away from the outlet of the Exhalation Valve EXH2105A To reinstall the Flow Sensor and Exhalation Valve EXH2105A reverse the above steps NOTE To reconnect the cable to the sensor body take
74. n back to acceptable values during the alarm condition In addition there are built in alarms limits for monitoring low baseline pressure high baseline pressure sustained high baseline pressure gas supply failure device alert and power switchover If a condition such as low battery power during battery operation or component malfunction occurs and the ventilator cannot maintain reliable operation it declares a Device Alert alarm This alarm cannot be silenced without first powering off the ventilator An Alarms and Message Bar on the GUI clearly displays all alarm and informational messages An alarm lamp on the top of the device lights with all alarms It can be viewed from 360 In addition a separate control panel indicator lights in case of a Device Alert The exhalation system is heated to prevent moisture in the exhaled gas from being condensed in the exhaled flow monitor system It features low exhalation flow resistance to allow rapid return to baseline pressure after a positive pressure breath and SER360 A1106 APPENDIX 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
75. nds for Adult and 1 2 seconds for Ped Infant patient types NOTE When Pressure Support is set to zero CPAP the ventilator raises the pressure in the patient circuit to a target pressure of 1 5 above the set PEEP CPAP until the end of inspiration Volume Target Pressure Support SIMV and SPONT Volume Target Pressure Control breath type only For patient spontaneous breaths in the Volume Target Pressure Control SPONT and SIMV modes the ventilator delivers breaths with a constant pressure in the breathing circuit at a pressure equal to a ventilator selected level between PEEP CPAP 5 cmH O mbar and the Pressure Limit until the end of patient inspiration Each Volume Target Pressure Support spontaneous breath is delivered primarily according to the user selected Tidal Volume and Pressure Limit and is secondarily affected by PEEP CPAP Slope Rise and Expiratory Threshold settings These are very much like pressure support spontaneous breaths but unlike the pressure support spontaneous breaths delivered when Pressure Control or Volume Control breath type is selected the pressure support level is managed breath by breath by the ventilator to a level that is between 5 2 above and the Pressure Limit setting in order to try to achieve the set Tidal A 5 THEORY OPERATION Safety Features A 6 Volume The set Tidal Volume is not guaranteed for each breath it is a target
76. ntilator Wait at least 10 seconds and turn the e360 ventilator power back ON Wait until Ventilation Standby screen appears Press Start Ventilating to begin ventilating NOTE Because gas supplies are not connected you will get an Loss alarm Disregard alarm while verifying software is installed correctly After Start Ventilation button is pressed confirm that Incompatible Software Message does not show up on the screen If this message appears on the LCD touch screen then the software download was NOT completed successfully Repeat 1 6 again If the same problem still remains then contact NMI representative for further assistance Press Extended Functions button on the Front control panel Press Event History button on LCD touch screen Confirm software is properly upgraded by checking software version number see Figure 2 12 left upper corner SER360 A1106 SECTION 2 __WENTEATORSETTINGS nire 1 o dm Figure 2 12 Event History Log Screen 17 The new Software version is now downloaded successfully 18 Remove USB Flash Drive from the USB Port on the back of the e360 ventilator Circuit Check Test and Diagnostic SER360 A1106 WARNING Before returning the e360 ventilator back for patient use after the software upgrade you must perform the following 1 Turn OFF the po
77. one for oxygen and one for air at a pressure of 30 to 90 pounds per square inch gauge psig Each inlet filter traps particles as small as 40 microns and includes a water trap to collect any water from the supply gas The filtered supply gas then enters a regulator that regulates pressure from 30 to 90 psig down to 15 psi Transducers monitor pressure at the regulators and a pressure drop at either regulator generates a low inlet pressure alarm The regulated gas enters the servo valves which are designed to supply gas to the patient circuit at the preset or ventilator managed flow A servo valve calibration creates a lookup table of the currents required to generate the range of flows from the servo valve The lookup table allows the ventilator to target the required flow as quickly as possible and feedback from the flow sensor every 10 milliseconds allows the ventilator to refine flow delivery Because the lookup table is unique to each combination of A 8 SER360 A1106 SER360 1106 APPENDIX 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 The flow sensors are hot wire anemometers as gas flows through the sensor it cools the wire and incre
78. op is solid on the red LED on the top is flashing and the message display reads Both Air O2 Supply Loss 6 on both gas supplies and clear the alarm Test 1 Set the to 0 21 2 Verify the value of displayed on LCD touch screen the FjOs reading measured by the oxygen analyzer and the 2 setting are within tolerance of 3 among each other Record the readings on the Test Record 3 Repeat step 1 with settings of 0 40 0 60 0 80 and 1 0 use Touch Turn Accept method to adjust settings 4 Set 2 to 0 21 NOTE Allow sufficient time for the calibration analyzer to stabilize at each setting before recording the calibration analyzer reading Main Flow Tidal Volume 1 Remove the test lung from the patient circuit Y Piece 2 Place the calibration analyzer at the Inhalation Outlet and set 1005000 the calibration analyzer to flow measurement 3 Press the button under the Tidal volume window and use the Touch Turn Accept method to adjust setting to 2 00 L 4 Press the Select button at the top of the Flow t Insp aa es window to choose Flow 5 Press Main Screen membrane button on control panel 6 Press the Numeric button on the LCD touch screen to display Numeric data 7 Set Flow to 5 L min verify the value of V peak Insp Flow displayed on the Numeric screen the flow reading measured by the calibration analyzer and the flow setting are within
79. r message Flow Sensor Cable disconnected Flow sensor defective Occluded or missing bacteria filter Dirty Exhalation flow sensor Exhalation heater failure Vent settings for Circuit Type humidity setup are incorrect for humidifier system in use Replace internal battery or replace the DC DC power supply PCB Recharge or replace battery Replace DC DC power supply PCB Ensure that both gas supplies have a pressure of at least 30 psig Calibrate air and oxygen regulators replace if calibration is not successful Calibrate servo valves replace if calibration is not successful Refer to Table 3 2 Device Alert Messages Reconnect cable to exhalation flow sensor Verify that pins in cable connector are not damaged Replace flow sensor Replace the bacteria filter Disassemble and clean the Exhalation Module replace the exhalation flow sensor Feel the bacteria filter If it is not warm to the touch replace the exhalation heater Correct Circuit Type selection in Patient Set up Defective oxygen sensor Replace the oxygen sensor Defective alarm speaker Sound processor board or SBC Replace alarm speaker or sound processor board or SBC 3 2 SER360 A1106 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
80. r to Volume Control A CMV Set Flow to 30 L min Press Setup amp Calibration button on the Control Panel and then press Patient Setup button on the LCD touch screen Press Circuit Type button on the LCD touch screen and set Circuit Type to HME by Touch Turn Accept method Press Main Screen button on the Control Panel and then press Numeric button on the LCD touch screen Set the calibration analyzer to volume measurement in BTPS mode and connect it in the inspiratory limb of the patient circuit Set Tidal Volume to 250 mL Verify the value of VTI displayed on Numeric screen the tidal volume reading measured by the calibration analyzer and the Tidal Volume setting are within tolerance of 10 among each other Record readings on the Test Record Repeat step 7 with Tidal Volume settings of 500 mL and 11 Connect the calibration analyzer in the expiratory limb of the patient circuit 6 11 OPERATIONAL VERIFICATION PROCEDURE Alarm Silence Set Tidal Volume to 250 mL Verify that the value of VTE displayed on Numeric screen is between 212 259 mL and verify that the tidal volume reading measured by the calibration analyzer and the Tidal Volume setting are within tolerance of 10 Record readings on the Test Record Set Tidal Volume to 500 mL Verify that the value of VTE displayed on Numeric screen is between 423 517 mL and that the tidal volume reading measured by t
81. r tube XD105 Remove 4 screws and washers Flow sensor cables CBL2116A Figure 4 21 Analog board PCB2104A Refer to figure 4 21 and follow these steps 1 Perform above steps for removal of Regulator and Solenoid Assembly BKT2105 2 Remove 5 tubes from PCB2104A e Orange tube exhalation valve pressure from XD107 Green tube Exhalation valve pressure from XD106 Blue tube Regulated oxygen pressure from XD103 Yellow tube Regulated air pressure from XD102 Clear tube Patient breathing circuit pressure from XD105 Note For transducers XD106 and XD107 the tubings are connected to the bottom ports of the transducers For transducers XD102 XD103 and XD105 the tubings are connected to the top ports of the transducers 3 Remove flat cable CBL2118A from J401 on PCB2104A 4 Remove oxygen sensor cable CBL2109A from J404 on PCB2104A 5 Remove air and oxygen flow sensor cables CBL2116A from J402 and J403 on PCB2104A 6 Remove 4 screws and washers securing PCB21044A to the e360 ventilator 4 21 COMPONENT REMOVAL 4 REPLACEMENT 7 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 4 22 Remove 2 screws and washers Heater HTR1200A Figure 4 22 Heater Assembly HTR2100A Refer to figure 4 22 and perform these steps
82. ser selected Pressure Limit and Inspiratory Time settings and is secondarily affected by Respiratory Rate PEEP CPAP and Slope Rise settings A Pressure Control inspiration terminates when the set Inspiratory Time has elapsed Available on specific models SER360 1106 APPENDIX A Volume Target Volume Target Pressure Control Each Volume Target Pressure Control mandatory breath is delivered primarily according to the user selected Tidal Volume Pressure Limit and Inspiratory Time settings and is secondarily affected by Respiratory Rate PEEP CPAP and Slope Rise settings These are much like pressure control mandatory breaths but unlike the pressure control mandatory breaths delivered When Pressure Control breath type is selected the pressure control level is managed breath by breath by the ventilator to a level that is between 5 2 above PEEP CPAP and the Pressure Limit setting in order to try to achieve the set Tidal Volume The set Tidal Volume is not guaranteed for each breath it is a target The first Volume Target Pressure Controlled mandatory breath delivered after Volume Target is turned ON is at a pressure control level equal to PEEP CPAP 5 cmH5O Spontaneous breaths in Volume Target Pressure Control SIMV and SPONT modes are Volume Target Pressure Support breaths Modes Of Ventilation Each breath type includes the choice of three modes e Assist Control Mandatory Ventilation A CMV e Synchronized Intermittent
83. splay and bend the cable up and push the connector on to CN1 then press the connector on to the double sided tape Reverse above steps 2 and 3 4 9 COMPONENT REMOVAL 4 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 1 Perform above steps to remove the Display Board PCB2102A 2 Using 5 64 hex key remove the set screw securing the control knob to the encoder and remove the knob 3 Remove Qty 8 screws and washers securing the CVR2104M to the front panel bezel BZL2105M 4 Remove the nut securing the flat ribbon cable ground to the side of front panel cover CVR2104M 5 Pull the front panel cover CVR2104M away from the front bezel and place in an ESD safe container 6 Toreinstall reverse above steps 2 through 5 4 10 SER360 A1106 SECTION 4 Removal and Replacement of Optical Encoder ENC1800P 1 3 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 Ibs of torque Removal and Replacement of Alarm LEDS 1 3 Perform above steps for removal the fron
84. st lung unattached Place the calibration analyzer at the patient circuit Y Piece Set the calibration analyzer to inspiratory time measurement Set the e360 ventilator to Pressure Control A CMV by pressing Pressure Control button until the A CMV LED is lit and then pressing Accept button to acknowledge Set Pressure Limit to 30 cmH5O Set t Insp to 0 25 seconds Verify the value of t displayed Numeric screen the inspiratory time reading measured by the calibration analyzer and the t Insp setting are within tolerance of x 0 05 seconds among each other Record the readings on the Test Record Set t Insp to 0 50 seconds Verify the value of tj displayed Numeric screen the inspiratory time reading measured by the calibration analyzer and the t Insp setting are within tolerance of x 0 10 seconds among each other Record the readings on the Test Record Set the calibration analyzer to breath rate measurement Set t Insp to 0 25 seconds and attach test lung to patient circuit Y Piece Set Resp Rate to 5 b min Verify the value of f tot displayed on Numeric screen the breath rate reading measured by the calibration analyzer and the Resp Rate setting are within 1 b min Record the readings on the Test Record Repeat step 3 with Resp Rate setting of 20 b min Set Resp Rate to 10 b min SER360 1106 Pressure Control Pressure Limit Pressure Support Trig Flow Pressure Support 10
85. straight out 3 Toreplace the Exhalation Valve Adapter orient the Adapter lip towards the inside of the instrument and press into place 4 Ensure that the Adapter is properly seated before re installing the Exhalation Valve and Exhalation Flow Sensor 2 4 SER360 A1106 SECTION 2 Exhalation Valve Diaphragm Seal amp O Ring Emergency Relief Diaphragm SER360 A1106 Exh Valve pus Nut Gollar Exh Valve Cap 2112 gt 1803 DIA1810M 1800 Diaphragm pu Poppet Assy r 1805 N E e PPT1801M 224 SEL1800M ORG1200P py SLD2110M SCR1830P y Exh Valve Body 27 N ORG2127P BDY2103M Figure 2 3 Diaphragm Seal amp O Ring Replacement Unscrew the Exhalation Valve Nut Collar and lift off Then lift off 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 Exhalation Valve Body see Figure 2 3 Front Panel Section Inh Outlet Assy Figure 2 4 Inhalation Outlet Assembly 2 5 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE Outlet Retaining Screws dcc 9 Inhalation Inhalation Outlet Block Diaphr
86. t Check button to begin START VENTILATING Figure 2 15 Ventilation Standby Screen SER360 A1106 SER360 1106 SECTION 2 2005 02 12 Ventilation Standby Circuit Check Test in Progress Ppeak PEEP FI yet VueLink Regional Circuit Comm come eee Settings u Check isplay E f e qo Sensors 08 Patient E ibt imam jp en 4 25 6 44 7 0 23 Figure 2 17 Technical Screen 2 17 MAINTENANCE OVERHAUL amp SOFTWARE UPGRADE Diagnostic Data TSI Air Flow TSI O2 Flow Exhale Flow Air Gas Supply O2 Gas Supply Machine 1 Machine 2 Drive Pressure Message ID Figure 2 18 Diagnostic Data Screen 2 18 SER360 A1106 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 e360 Mode WWE 055 0 Cther Language Current Hours e360 Model Serial Number Old software version Updated software version Company performing service Address of company performing service Software Updated by Exhalation Flow Sensor Calibration d9 performed by SER360 1106 2 19 3 TROUBLESHOOTI
87. t panel cover CVR2104M For each of the alarm LEDS remove Qty 2 screws securing the boards to the CVR2104M To reinstall reverse above step 2 Note The red LED is p n LED2101P and amber LED is p n LED2102P Removal and Replacement of LCD Display DSP2105P Refer to figure 4 8 and 4 9 and follow these steps 1 2 SER360 1106 Perform above steps for removal of CBL2105A Remove the 4 nuts and washers securing the LCD housing BKT2104M to the CVR2104M Remove the 4 screws securing the BKT2104M to the LCD display DSP2105P To reinstall reverse above steps 2 and 3 COMPONENT REMOVAL 4 REPLACEMENT Removal and Replacement of Touch Screen PNL2105P 4 12 BZL2105M Affix tape 0 10 from the inside edge P Y _ Figure 4 10 Touch Screen Panel 2105 Note Removal of the touch screen PNL2105P will destroy the screen do not remove unless you have a replacement touch screen PNL2105P Refer to figure 4 10 and follow these steps 1 Perform above steps for removal of the LCD display DSP2105P Using a flat screw driver pry the touch screen away from the front bezel BZL2105M To install a new touch screen clean all tape and adhesive from the front bezel and wipe clean with isopropyl alcohol Apply 4 pieces of double side tape p n TAP1200P around the perimeter of the bezel The tape should be placed 0 10 from the inside edge Press the tape firmly onto the bezel Peel back the protecti
88. the user may choose to pressure support the spontaneous breaths In Volume Target Pressure Control all spontaneous breaths are Volume Target Pressure Support breaths The Respiratory Rate setting determines the total number of mandatory breaths delivered each minute The Respiratory Rate setting also establishes a timing window that determines whether a patient trigger results in a mandatory breath or a spontaneous breath The Trig setting determines the airway pressure or airway flow threshold that the patient s effort must reach in order to trigger mandatory breaths and also to trigger spontaneous breaths in between mandatory breaths If there are no patient breathing efforts or if patient efforts fail to cause enough airway pressure or airway flow change to meet the set Trig threshold the patient receives the number of time triggered breaths each minute selected via the Respiratory Rate setting Spontaneous SPONT In SPONT all breaths delivered to the patient are spontaneous breaths When Volume Control or Pressure Control breath types are selected the user may choose to add Pressure Support to assist spontaneous efforts When Volume Target Pressure Control breath type is selected all spontaneous efforts are assisted by Volume Target Pressure Support The Trig setting determines the airway pressure or airway flow threshold that the patient s effort must reach in order to trigger spontaneous breathing assistance from the vent
89. tolerance of 1 L min among each other Record the readings on the Test Record 6 6 SER360 A1106 SER360 1106 SECTION 6 8 Set Flow to 10 L min verify the value of peak Insp Flow displayed on the Numeric screen the flow reading measured by the calibration analyzer and the flow setting are within tolerance of 1 L min among each other Record the readings on the Test Record 9 Set Flow to 50 L min verify the value of peak Insp Flow displayed on the Numeric screen the flow reading measured by the calibration analyzer and the flow setting are within tolerance of 4 L min among each other Record the readings on the Test Record Record the readings on the Test Record 10 Set Flow to 80 L min verify the value of peak Insp Flow displayed on the Numeric screen the flow reading measured by the calibration analyzer and the flow setting are within tolerance of 5 L min among each other Record the readings on the Test Record 11 Set to 100 and set the calibration analyzer to oxygen flow measurement 12 Repeat steps 7 10 Record the reading on the Test Record 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 13 Set to 21 Flow to 30
90. ton to acknowledge NOTE Steps 4 to 14 are to calibrate zero pressure offset of the Exhalation drive pressure transducer XD107 Remove the ORANGE tubing from transducer XD107 on the Analog PCB Press the Manual Inflation button to start the offset calibration The Message ID will change to 25 Refer to Table 5 5 for the descriptions of all message ID s Verify the setting of t Insp 15 0 If not press the button below Flow t Insp window then the display will start blinking While the display is blinking turn the Adjustment Knob to adjust the setting of t Insp to 0 and then press the Accept button to acknowledge Press the button below Resp Rate window then the display will start blinking While the display is blinking turn the Adjustment Knob to change the setting to any value and then press the Accept button to acknowledge After the Accept button is pressed the value of Drive Pressure displayed on the LCD touch Screen will change SER360 1106 SER360 1106 11 12 13 14 15 16 17 18 19 20 21 22 23 24 SECTION 5 As the setting of Resp Rate increases the value of Drive Pressure will decrease after the Accept button is pressed As the setting of Resp Rate decreases the value of Drive Pressure will increase after the Accept button is pressed When the setting of Resp Rate is 0 which cannot further decreased consequent
91. upply The power supply converts alternating current to direct current and accepts any voltage or frequency within the specified range Direct current from the power supply enters the DC DC PCB which supplies operating voltage to other PCBs includes circuitry for external battery connection and battery operation and powers the fan and heater The Main PCB accepts input from the oxygen sensor and servo valves acts as motherboard for the ventilator including the secondary Backup alarm The Main PCB powers and receives signals from the Analog PCB The Analog PCB accepts signals from the flow sensors and includes all ventilator transducers The Solenoid PCB includes all valve controls solenoids except for the exhalation valve solenoid attached to the jet pump The Single Board Computer Board includes all of the video interface USB RS232 Primary Audio Alarm and Touch Screen interfaces SER360 1106 APPENDIX ORDERING 8 CONTACT INFORMATION Ordering Parts and B 1 Contact Technical B 3 Return e360 for B 3 Submit a Product Complaint B 4 APPENDIX 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 C
92. ustomer Service Telephone voice mail 800 451 3111 extension 282 only in USA 714 427 5811 extension 282 Fax 714 427 0489 Customer Service department hours Monday through Friday 8 00 am to 5 00 pm USA Pacific Time Table B 1 e360 Ventilator Spare Parts List Description Part Number PREVENTIVE MAINTENANCE KIT PMK360A OVERHAUL KIT OVL360A 12 VOLT 7 2 AH AMP HOUR BATTERY BAT1800P ADAPTER EXHALATION ADP2105M ANALOG BOARD PCB2104A AUDIO BOARD PCB2106P SAFETY REGULATOR REG1802P BUZZER BZR1001P CABLE ASSEMBLY SPEAKER CBL2120A CABLE ASSY AC POWER INPUT CBL2115A CABLE ASSY ANALOG PCB CBL2118A CABLE ASSY DC DC TO BATTERY amp SWITCH CBL2111A CABLE ASSY DC DC TO SBC CBL2108A CABLE ASSY EXH PCB TO MAIN PCB CBL2122A CABLE ASSY INHALATION FLOW SENSOR CBL2116A CABLE ASSY LCD DISPLAY TO SBC CBL2105A CABLE ASSY MAIN TO BACK PANEL CBL2113A CABLE ASSY MAIN TO DC DC CBL2101A CABLE ASSY MAIN TO DISPLAY BOARD CBL2106A CABLE ASSY MAIN TO TOP AMBER LED CBL2125A CABLE ASSY MAIN TO 02 SENSOR CBL2109A CABLE ASSY MAIN TO POWER SUPPLY TO DC DC CBL2103A CABLE ASSY MAIN TO SINGLE BOARD CBL2110A CABLE ASSY MAIN TO SOLENOID ASSY CBL2107A CABLE ASSY MAIN TO TOP RED LED SER360 A1106 CBL2102A B 1 ORDERING 4 CONTACT
93. ve cover on the double sided tape to expose the adhesive carefully place the new touch screen PNL2105P on to the tape and press firmly Clean inside panel of debris and fingerprints before reinstalling the LCD display PNL2105P SER360 A1106 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 SER360 A1106 4 13 COMPONENT REMOVAL 4 REPLACEMENT Cover CRV2115M with Gasket GKT2101M Figure 4 13 Cover CRV2115M and Gasket GKT2101M Refer to figures 4 11 4 12 and 4 13 and follow these steps 1 Perform steps above for Removal of Top Cover and Front Panel Assembly Remove 6 screws securing the pneumatics cover CVR2106M Remove the 2 screws securing the cover CVR2115M and gasket GKT2101M Remove the yellow tube and blue tube from the air and oxygen inlet manifold BLK2115M Remove the 4 screws securing the pneumatics panel PNL2102M 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 releasin
94. w and press the Accept button to select Flow 7 Press the Manual Inflation button to enable manual flow adjustment The message ID will change to 12 8 Press the button below the Flow t Inst window then the display will start blinking 9 While the display is blinking turn the Adjustment Knob to change the setting from 0 to 3 Then press the Accept button to acknowledge This is to obtain a flow of 3 L min 10 Verify the value of Air Gas Supply is 15 5 0 5 psig Adjust the Air Inlet Pressure Regulator if not within specification 11 To adjust the Air Inlet Pressure Regulator use a 5 16 open ended wrench to loosen the bottom lock nut see Figure 5 3 Using a 1 4 open ended wrench rotate the top adjustment bolt to adjust the pressure Rotate the bolt clockwise to increase the pressure and counter clockwise to decrease the pressure When the value of Air Gas Supply is 15 0 0 5 psig secure the bottom lock nut Lock nut Adjustment bolt By Figure 5 3 Air Oxygen Pressure Regulators Adjustment 12 Adjust Flow as shown below and verify that the expected regulated pressure for each flow setting is within tolerance 5 10 SER360 A1106 SECTION 5 Table 5 4 Flow 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 gt 9 5 psig Oxygen Inlet Regulator 1 While still in Diagnostic Mode d3
95. w sensor requires a short calibration before it is put into use The calibration is performed by the user at ventilator start up and may also be initiated by the user during ventilation if calibration is suspect Gas from the exhalation valve flows to the exhalation flow sensor The exhalation valve includes a flexible silicone exhalation diaphragm and drive pressure from the jet pump opens and closes the diaphragm to manage pressure in the breathing circuit and allow patient exhalation The exhalation solenoid is a small servo valve that controls pressure to the exhalation valve diaphragm by varying its outlet size Gas from the exhalation solenoid enters the jet pump where it flows through a jet nozzle to create drive pressure to the exhalation valve diaphragm The low mass of the jet pump allows it to operate without the complications caused by oscillation of a larger part SER360 A1106 SER360 1106 A pressure transducer 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 Excess flow from the jet pump vents through the muffler Electronics Power to the ventilator enters the A C inlet which connects to the power s
96. wer of the e360 ventilator 2 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 see Figure 2 13 for Air Inlet 3 Connect appropriate patient circuit to the e360 ventilator as shown in Figure 2 14 Occlude the patient circuit using a CAP A filter and test lung are not required for this instruction 4 Turn the power of the e360 ventilator back ON 5 Wait until Ventilation Standby screen appears Follow the instructions that appear on LCD touch screen as shown in Figure 2 15 2 13 MAINTENANCE OVERHAUL 8 SOFTWARE UPGRADE 7 10 11 12 13 14 15 16 17 18 19 20 21 Press Circuit Check button on LCD touch screen and Circuit Check Test in Progress massage appears on LCD touch screen as shown in Figure 2 16 When circuit test is completed successfully Circuit Check PASSED message appears on LCD touch screen If circuit test failed Circuit Check FAILED message appears on LCD touch screen Please check the breathing circuit for leaks and press Circuit Check button on LCD touch screen and repeat Circuit Check If circuit check does not pass please contact NMI representative for further assistant Press Setup amp Calibration button on the Control Panel Press TECHNICAL button on LCD touch screen see Figure 2 1
97. y 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 WARNING A WARNING describes a condition that can cause personal injury Caution A Caution describes a condition that can cause damage to equipment NOTE A NOTE emphasizes information that is important or convenient 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 regular intervals Operational Verification a routine verification procedure to ensure proper operation Overhaul Procedure a procedure for replacing key components at regular intervals Please review all warnings and cautions in this manual before attempting to service the ventilator Warnings and Cautions appear throughout this manual where they are relevant The Warnings and Cautions listed here apply generally any time you work on the ventilator 1 1 INTRODUCTION GENERAL CAUTIONS WARRANTY WARNING To maintain grounding integrity connect only to a hospital grade receptacle Always disconnect power supply before servicing the e360 ventilator DANGER there is a risk of explosion if used in the presence of flammable

NEWPORT E-360 Ventilator Service Manual

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