e360 Service Manual SER360 Rev A Nov 2006

TABLE OF CONTENTS

Section 1...INTRODUCTION Section 2 ...MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE

Section 3 ...TROUBLESHOOTING GUIDE

Section 4 ...COMPONENT REMOVAL & REPLACEMENT Section 5 ...CALIBRATION PROCEDURES

Section 6 ...OPERATIONAL VERIFICATION PROCEDURE

Section 7 ...CLEANING and MAINTENANCE Appendix A ...THEORY OF OPERATION

Appendix B ...ORDERING & CONTACT INFORMATION

Appendix C ...DIAGRAMS

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1. INTRODUCTION Introduction ... 1-1 Definitions ... 1-1 General Warnings... 1-1 General Cautions ... 1-2 Warranty ... 1-2 Factory Service... 1-3 Copyright Information ... 1-3 Contact Information ... 1-3

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SECTION 1

INTRODUCTION

It is very important to read and understand all of the information in this manual before attempting to service the e360 Ventilator. Please review all warnings and cautions in this manual before attempting to service the e360 ventilator.

DEFINITIONS

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

GENERAL WARNINGS 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.

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1-1

INTRODUCTION

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 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.

GENERAL CAUTIONS

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.

WARRANTY 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 1-2

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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 equipment. Please fill out the self-addressed Warranty Registration Card included with the product and return it to Newport promptly. Or register online at www.NewportNMI.com.

FACTORY SERVICE Scheduled maintenance or repair services are available from the Newport Technical Service department. 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 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.

CONTACT INFORMATION

Address:

Newport Medical Instruments 1620 Sunflower Avenue Costa Mesa, California, USA 92626

Phone numbers: Toll-free within the United States: 800.451.3111 Worldwide: 1.714.427.5811

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Fax numbers:

Main Fax: 1.714.427.0489 Technical Service Fax: 1.714.427.0572

Website:

www.NewportNMI.com/ www.Ventilators.com

Email:

[email protected] [email protected] 1-3

INTRODUCTION

Department extensions:

Customer Service: 282 Technical Service: 500 (24-hour pager activated) Clinical Support: 123 (24-hour pager)

Corporate Office Monday through Friday, 8:00 am to 5:00 pm hours: (USA Pacific Time) EU Representative: Newport Medical Instruments Att. Robert Brink c/o Braun & Co. 19 Pasture Rd. Barton-on-Humber North Lincolnshire DN18 5 HN, England tel: ++44.77 68 231311 Fax: ++44.1652.633399

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

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MAINTENANCE & OVERHAUL INTERVALS

SECTION 2

The Level I 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 if 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.

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MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE GENERAL CAUTIONS

Caution Clean all external parts of the e360 ventilator prior to service. Use only dry, clean compressed air and medical grade oxygen. Water in the air or oxygen supply can cause ventilator malfunction or damage. 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 Medium Phillips screwdriver Needle Nose pliers

PARTS REQUIRED

Preventive Maintenance Kit

2-2

The Preventive Maintenance Kit (PMK360A) includes the following items: Part Number

Quantity

Description

JFK100P

2

JAR Filter Kit

ADP2105M

1

Exhalation Valve Adapter

DIA1800M

1

Emergency Relief Diaphragm

SEL1800M

1

Exhalation Valve Seal

ORG1200P

1

O-Ring, Exhalation Flow Sensor

DIA1810M

1

Exhalation Valve Diaphragm

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Overhaul Kit

SECTION 2 The Overhaul Kit (OVL360A) includes the following items: Part Number

Quantity

Description

JFK100P

2

JAR Filter Kit

RRK1800P

2

Regulator Rebuild Kit

GRD1800P

1

Cooling Fan Filter & Guard

ADP2105M

1

Exh. Valve Adapter

PPT1805A

1

Exh. Valve Dia & Poppet Assy

ORG1200P

1

O-Ring, Exhalation Flow Sensor

DIA1800M

1

Emergency Relief Diaphragm

VLV100P

1

Emergency Intake Diaphragm

VLV2100M

1

Inhalation Outlet Check Valve Diaphram

BAT1800P

1

Internal Battery

MAINTENANCE PROCEDURES

WARNING: Disconnect electrical power, air and oxygen sources before attempting any disassembly.

Inlet Water Trap Filters & O-ring Assembly

1

2 SER360 A1106

Figure 2-1 Inlet Water Trap Filter Replacement Unscrew the collection bowl from the inlet water trap. Unscrew the filter holder. 2-3

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE 3 4

Remove and replace the inlet filter and O-ring. Reinstall the filter holder and reassemble the water trap assembly.

Retaining Latch Adapter Lip

Valve Adapter

ADP2105M Exhalation Valve Adapter

1 2 3 4

2-4

Figure 2-2 Exhalation Valve Adapter Replacement Access the Exhalation Valve Adapter by lifting the Retaining Latch and removing the Exhalation Valve and Exhalation Flow Sensor, see Figure 2-2 above. To remove the silicon Exhalation Valve Adapter, use your finger to grasp the Adapter and pull it straight out. To replace the Exhalation Valve Adapter, orient the Adapter lip towards the inside of the instrument and press into place. Ensure that the Adapter is properly seated before re-installing the Exhalation Valve and Exhalation Flow Sensor.

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SECTION 2

Exhalation Valve Diaphragm, Seal & O-Ring Exh. Valve Nut Collar NUT1802M

Exh. Valve Cap CAP2112M CAP1803M DIA1810M PPT1800M

Diaphragm Poppet Assy PPT1805A

PPT1801M SEL1800M SLD2110M

ORG1200P

SCR1830P

Exh. Valve Body BDY2103M

1 2 3 4 5

ORG2127P

Figure 2-3 Diaphragm, Seal & 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.

Emergency Relief Diaphragm Inh. Outlet Assy

Figure 2-4 Inhalation Outlet Assembly SER360 A1106

2-5

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Outlet Retaining Screws

Inhalation Adapter

1 2 3 4 5 6

OVERHAUL PROCEDURES

Inhalation Outlet Block

Emergency Relief Diaphragm DIA1800M

Emergency Valve Cap

Figure 2-5 Emergency Relief Diaphragm Replacement Access the Inhalation Outlet Assembly by removing the Lower Right Front Panel, see Figure 2-4 above. Remove the Inhalation Outlet Assembly by removing the two retaining screws, see Figure 2-5 above. Remove 4 screws from Emergency Valve Cap to expose the Emergency Relief Valve. Insert finger and pull the Emergency Relief Diaphragm (DIA1800M) out of Inhalation Outlet Block. Replace the Emergency Relief Diaphragm. To reinstall components and assembly, reverse the above procedure.

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.

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SECTION 2

Air and Oxygen Inlet Regulator Rebuild

Diaphragm

Cover Spring

O-Ring

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 disassembly and re-assembly. To install the Air and Oxygen Inlet Regulators Rebuild Kits, refer to Figure 2-6 and do the following: 1 2

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). 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.

Exhalation Valve Adapter To replace the Exhalation Valve Adapter, follow the procedures given in the Preventive Maintenance at the beginning of this section.

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MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Exhalation Valve Diaphragm/Poppet Assembly

Refer to Drawing 2-3 1 2 3 4

Unscrew the Exhalation Valve Nut Collar and lift off. Then lift off the Exhalation Valve Cap and Diaphragm/Poppet Assembly. Replace complete Diaphragm/Poppet Assembly (p/n PPT1805A). Reverse step 1 to reassemble the Diaphragm/Poppet Assembly, Exhalation Valve Cap, and Exhalation Valve Nut Collar. Locate and replace O-ring (ORG1200P) inside the Exhalation Valve Body, see Figure 2-3.

Cooling Fan Filter & Guard

Cooling Fan Filter & Guard

Figure 2- 7 Filter and Guard Assembly Replacement Replace the Cooling Fan Filter and Guard Assembly (GRD1800P), see Figure 2-7.

2-8

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SECTION 2

Emergency Relief Diaphragm Emergency Intake Diaphragm

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)

1 2 3 4 5 6

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Figure 2-8 Emergency Intake Diaphragm Replacement Remove Top Cover following procedure in Section 4 of this manual, “Removal of Top cover”. Remove Pneumatics Panel following procedure in Section 4 of this Manual, “Removal of Pneumatics Panel Assembly”. Remove Inspiratory Flow Sensors following procedure in Section 4 of this manual, “Removal of Inspiratory Flow Sensors”. Remove two Emergency Intake Valve retaining screws, see Figure 2-8 above. Remove the Emergency Intake Valve using Needle Nose Pliers. Replace the Emergency Intake Diaphragm (VLV100P) and reinstall assembly by reversing procedure above.

2-9

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE Inhalation Outlet Check Valve

Inhalation Outlet Check Valve

1 2 3 4 5

Figure 2-9 Inhalation Outlet Check Valve Remove the Mixing Block by removing the two retaining screws, see Figure 2-8. Remove the Inhalation Adapter from the Inhalation Outlet Assembly, see Figure 2-5. Insert finger and push out the Inhalation Outlet Check Valve, see Figure 2-9. Replace the Inhalation Outlet Check Valve Diaphragm (VLV2100M). To reinstall components and assembly, reverse 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

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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 e360 System Pneumatic Diagram (SPD2100A) located in Appendix C to cut each tube to length and replace the worn tubing in the e360 ventilator.

Upon Completion 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

The following items are required for software upgrade: • Latest Software on USB Flash Drive • Software Upgrade Instructions • NMI Reusable Patient Circuit (PBC340A) or equivalent • Cap to plug end of patient circuit (CAP100P) or equivalent

UPGRADE PROCEDURE

Note: Follow this procedure to reload software after performing a Main Board, Display Board or Single Board Computer component replacement. 1 2 3 4 5 6

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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). Press and hold the “Accept” button and turn ON the power. Release the “Accept” button when NMI Logo Screen is displayed. Wait for few minutes until the Software Download/Diagnostics Mode screen is displayed, see Figure 2-11. Connect USB Flash Drive (with latest software) to the USB port on the Back Panel of the e360 ventilator (see Figure 2-13 for USB port location).

Press “Start Download” on touch screen (Figure 2-11). The e360 ventilator will sound a short beep. “Touch Selection to Begin” message on screen will change to a flashing message: “downloading….” Wait 15 – 20 minutes for software download to complete. 2-11

MAINTENANCE, OVERHAUL & SOFTWARE UPGRADE

7 8 9

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 ventilator. Wait at least 10 seconds and turn the e360 ventilator power back ON.

10 Wait until “Ventilation Standby” screen appears. 11 Press “Start Ventilating” to begin ventilating.

12 NOTE: Because Air/O2 gas supplies are not connected you will get an “Air/O2 Loss” alarm. Disregard alarm while verifying software is installed correctly. 13 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. 14 Press “Extended Functions” button on the Front control panel. 15 Press “Event History” button on LCD touch screen.

16 Confirm software is properly upgraded by checking software version number (see Figure 2-12, left upper corner).

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