S8 Elite and AutoSet Service Manual Rev 4

ResMed Ltd (Manufacturer) 1 Elizabeth MacArthur Drive Bella Vista NSW 2153 Australia ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA ResMed (UK) Ltd (EU Authorised Representative) 64 Milton Park Abingdon Oxfordshire OX14 4RX UK ResMed Offices Australia, Austria, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details). Protected by patents: AU 691200, AU 697652, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU 750761, AU 764761, AU 779327, EP 0651971, EP 0661071, EP 0920845, EP 0934723, EP 1028769, EP 1502618, JP 3580776, NZ 504595, US 4944310, US 5199424, US 5245995, US 5522382, US 5704345, US 6029665, US 6138675, US 6240921, US 6363933, US 6367474, US 6398739, US 6425395, US 6502572, US 6591834, US 6635021, US 6705315, US 6745768, US 6817361, US 6988498, US 7004908, US 7040317. Other patents pending. Protected by design registrations: AU 302180, AU 302181, AU 302182, AU 302183, AU 302184, AU 302185, AU 302186, CN 200430121212.2, CN 200430121211.8, CN 200430121214.1, CN 200430121215.6, CN 200430121216.0, CN 200430121217.5, EP 269436, HK 0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP 1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924. Others pending. S8, S8 AutoSet Respond, S8 AutoSet Spirit, S8 AutoSet Vantage, S8 Elite and S8 AutoScore are trademarks of ResMed Ltd and AutoSet is Registered in U.S. Patent and Trademark Office © 2007 ResMed Ltd. 338202/4 07 04

Contents 1

How to use this manual ... 4

2

Introduction ... 5

3

Intended users of this manual Nasal CPAP

6 6

Features of the flow generators

6

General inspection and servicing ... 7 Instructions for general inspection procedures

7

Equipment required Software Icons Function keys 1 Clean the flow generator 2 Record clinical settings 3 External examination 4 Internal examination (if necessary) 5 Replace the air filter 6 DC power test 7 Keypad test 8 H3i test 9 Data card test 10 Pressure calibration test 11 Flow calibration test 12 SmartStop test 13 Blower test 14 LCD test 15 Audible alarm test 16 Reload clinical settings 17 Set clock 18 Complete the Record of Service form 19 Fill out product problem report

7 8 8 8 9 11 11 12 12 12 12 14 14 15 15 15 15 15 16 16 17 17

4

Operator safety and static precautions ... 18

5

Replacing major subassemblies ... 19 Outer components of the S8 Elite/AutoSet Opening the flow generator Remove the filter Remove the top case Replacing the main PCB Installing the serial number Replacing the LCD Replacing the motor Replacing the power supply Replacing the flow sensor

Replacing the interface panel, keypad and handle Closing the flow generator

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S8™ Elite/AutoSet Service Manual

19 20 20 20 22 24 25 26 30 32

35 37

Opening the muffler Replacing the latch hook Closing the front muffler

6

40 41

Replacement parts list ...42 Outside cases Interface assembly Air filter components Internal components PCBs Front muffler Also available

7

38

42 43 43 43 45 45 46

Calibration procedures ...47 Equipment required Calibration Icons Order of calibration procedures 1 Pressure calibration 2 Flow calibration 3 Motor noise calibration

47 47 47 48 48 49

8

Troubleshooting guide ...50

9

System specifications ...52 Symbols which appear on the device

52

10 Recommended maintenance schedule ...53 Appendix A: Service request form ...54

Contents

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1

How to use this manual Each of the sections in this manual have been written with a specific purpose in mind. Use this guide to help you find the material which is relevant to your task at the moment. 2 Introduction – Gives a brief overview of the S8 Elite/AutoSet. 3 General inspection and servicing – Gives the procedures to help you examine a flow generator which has been brought into a service centre. The general inspection procedures should be performed before any other work is done on the flow generator. 4 Operator safety and static precautions – Provides safety advice and lists procedures to be followed whenever PCBs are removed from the S8 Elite/AutoSet unit. These procedures minimize the chance of ICs being damaged by static electricity. 5 Replacing major subassemblies – Highlights points to note when replacing subassemblies, reassembling the flow generator and indications of when recalibration is necessary. 6 Replacement parts – Shows labelled pictures and part numbers of all the spare parts and subassemblies available from ResMed. 7 Calibration procedures – Procedures to follow after a fault has been isolated to a PCB, the blower or the flow meter, and the part has been replaced. Follow these procedures to calibrate the unit. Once calibrated, restore the owner’s individual settings. 8 Troubleshooting guide – Gives you a way to quickly locate the problem and fix it if you know the symptoms of a faulty machine. 9 System specifications – Lists electrical and mechanical specifications of the flow generator and air tubing. 10 Recommended maintenance schedule – Provides a brief description of the maintenance which the owner of the flow generator should carry out. Some countries require all medical equipment to have a periodic service to confirm that the equipment is in good working order. Section 3, “General inspection and servicing” may be used in this situation. Appendix A: Service Request Form - Whenever you locate a fault in an S8 Elite/AutoSet, fill out this form and return it to ResMed for logging. Note:

Schematics of all PCBs in these flow generators are available to authorised service centres. To order, please contact your local ResMed office.

This manual contains special terms and icons that appear in the margins to draw your attention to specific and important information.

• Warning alerts you to possible injury. • Caution explains special measures for the safe and effective servicing of the device. • Note is an informative or helpful note.

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S8™ Elite/AutoSet Service Manual

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Introduction This manual is a guide to servicing and repairing the following ResMed flow generators: S8 Elite/AutoScore group

• • • • • •

33021 - S8 Elite (Americas) 33026 - S8 Elite (France) 33027 - S8 Elite (EUR G2) 33028 - S8 Elite (EUR G1) 33031 - S8 Elite (Germany) 33033 - S8 AutoScore (ANZ)

S8 AutoSet Spirit/Vantage group

• • • • • • • • • •

33112 - S8 AutoSet Vantage (Americas) 33113 - S8 AutoSet Spirit (EUR G1) 33121 - S8 AutoSet Spirit (AP) 33122 - S8 AutoSet Spirit (France) 33123 - S8 AutoSet Spirit (UK) 33124 - S8 AutoSet Spirit (Germany) 33125 - S8 AutoSet Spirit (EUR G2) 33126 - S8 AutoSet Spirit (ANZ) 33105 - S8 AutoSet C (Teijin) 33128 - S8 Respond (Japan)

It is written for ResMed distributors, and gives instructions for replacing subassemblies and for recalibration as appropriate. Work at the component level will normally be carried out by ResMed.

2 Introduction

5

Intended users of this manual Before attempting any repair work, please ensure that you:

• are familiar with the operating manual and the clinical manual for the product • have suitable electrical and mechanical training to satisfy the requirements of the relevant regulatory authorities

• use the correct antistatic procedures described in this manual Use only approved ResMed parts and never use parts that have failed, show excessive wear, have been contaminated, or are ineffective for their intended use.

Nasal CPAP Nasal Positive Airway Pressure systems are used to treat obstructive sleep apnea, a disorder that causes a physical obstruction in a person’s airway while sleeping. The principle of treatment is that filtered air is delivered by a flow generator through flexible tubing to a nasal mask worn by the patient while sleeping. The flow generator maintains a positive pressure in the patient’s airway which acts as a pneumatic splint, preventing the airway from collapsing during sleep.

Features of the flow generators The S8 Elite/AutoScore and S8 AutoSet Spirit/Vantage flow generators are designed to provide CPAP therapy to patients with OSA. The S8 AutoSet Spirit/Vantage flow generators have two therapeutic modes: AutoSet mode and CPAP mode. The AutoSet mode is not available in the S8 Elite/AutoScore flow generators. Note:

6

Schematics of all PCBs in this flow generator are available to authorised service centres. To order, please contact your local ResMed office.

S8™ Elite/AutoSet Service Manual

3

General inspection and servicing Instructions for general inspection procedures Carry out the procedures on the following pages to confirm that the S8 Elite/AutoSet is in good electrical and mechanical condition. These tests will highlight any major mechanical or electrical problem with the unit.

Equipment required • ResMed S8 Series Service Software 2.01 (33954) or available in service software kit 33953 which includes S8 serial adaptor, null modem cable, oxygen sideport connector, straight adapter, standard mask frame, closed bubble cushion and security key.

• • • • • •

Null modem cable (ResMed part # 17952) Oxygen side port connector (ResMed part # 14915) Straight adaptor (Z316) S8 serial adaptor (ResMed part # 22201) DC-12 converter (ResMed part# 33942) HumidAire 3i docking station

• Data card • Security key (ResMed part # 19331) Note:

The Security key used to service the AutoSet® Spirit is appropriate for use with the S8 Series Service Software.

• 2 metre air hose (ResMed part # 14961) • Manometer (0-30 cm H2O range) • Calibrated flow meter with flow regulation valve Note:

The flow meter must be capable of measuring air flows ranging from 0 - 180 L/min with an accuracy of 3% or better over this range.

• A computer running Windows 2000 or XP.

3 General inspection and servicing

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Software Icons Open flow generator settings dialog

Perform the LCD test

Perform the pressure calibration test

Perform the audible alarm test

Perform the flow calibration test

Set time and date

Perform the blower test

Record

SmartStop test

Record of service

Function keys

LCD screen Up key Left key

Right key

Down key Start/Stop key

1

Clean the flow generator Before servicing the unit it should be wiped down using a lint free cloth and a cleaning agent with a high alcohol content, e.g. isopropyl alcohol.

Warning

!

When using a cleaning agent with a high alcohol content refer to the appropriate Material Safety Data Sheet to ensure safe handling of the cleaning agent. Remove any stains from the cases. When removing any stains from the flow generator or mask system use soap or detergent-based cleaning solutions. Remove excess and wipe dry after use. Do not use thinners, trichlorethylene, bleach or other solvents. Do not apply oil to any component of the flow generator.

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S8™ Elite/AutoSet Service Manual

2

Record clinical settings 1 If applicable, remove the front muffler assembly. 2 With the unit unplugged from the wall, remove the data card module.

3 Connect the S8 serial adaptor to the flow generator. Press upwards and hold the button on the adapter, while pushing it onto the unit.

4 Turn on the flow generator and allow it to complete the self test. 5 Connect the flow generator to the computer via the null modem cable. S8 serial adaptor

Null modem cable

3 General inspection and servicing

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6 Open the S8 series service software. The following window will appear:

7 Select Settings>Flow generator settings from the main window, or press the Open flow generator settings dialog icon at the top of the main window. 8 The screen will appear with the unit settings:

The settings screen for an S8 AutoSet Vantage

9 Select File> Save screen settings to file, or select the floppy disk icon and save the settings under the unit’s serial number. 10 Remove the S8 adapter. Press upwards and hold the button on the adapter whilst pulling it away from the unit. 11 Refit the Data card module to the rear of the unit.

Caution

!

10

If the clinical settings can not be recorded, select the appropriate product code, press the Default button and save the file with the default settings for the faulty unit. Notify the patient, so they can have their settings reloaded.

S8™ Elite/AutoSet Service Manual

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External examination 1 Visually examine the flow generator for external damage such as: • deformation or cracking of the upper or lower cases • damaged components such as the mains power inlet • damage to the interface panel or bottom decal If either of the outside cases are fractured and require replacement, take particular care in inspecting all other components within the cases for damage. 2 Select Forms>Record of service, or press the Record of service icon. 3 Open the file saved earlier, containing the unit’s clinical settings. 4 Check the appropriate box for the external examination.

4 Warning

!

Internal examination (if necessary) The S8 Elite/AutoSet uses an isolated power supply, however, it is recommended that isolation transformers are also used for added safety while working with the cases opened up and power switched on. Remove the top case and chassis lid by following the instructions given in Section 5 Replacing major subassemblies. Inspect the flow generator for the following, recording any irregularities:

• • • •

The main PCB is seated correctly The blower assembly is seated correctly The flow meter is seated correctly The power supply PCB is seated correctly

Inspect the unit for the following, recording any irregularities:

• all mechanical components are seated correctly • all electrical components are mounted correctly and secured in position • there are no loose terminals, loose wires or incomplete insulation on electrical components or connections

• there are no loose pieces of wire or other objects trapped in the PCB Use an antistatic cloth or brush to remove dust or dirt from components and from the insides of the flow generator case. Repair or replace any missing or damaged external components. Rectify any problems either identified by the user or noted during servicing. Should any major components such as the blower assembly, the flow meter or the main PCB require replacement the flow generator should be recalibrated and tested after the assembly has been replaced. Follow the procedures in Section 7 Calibration procedures to calibrate the unit, then repeat tests 6-15 in Section 3 General inspection and servicing. Reassemble the flow generator. Record the results by checking the appropriate box in the General inspection results form.

Caution

!

Printed circuit boards can be damaged by static electricity. Please read the instructions in Section 4 Operator safety and static precautions before attempting to replace any PCBs. Thread cutting screws are used throughout the flow generator. When replacing a thread cutting screw, turn the screw anti-clockwise until it fits into the previously cut thread. Otherwise the original thread may be stripped out.

3 General inspection and servicing

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5

Replace the air filter 1 Remove the filter cover from the flow generator. 2 Replace the air filter, with the blue side of the filter material facing out from the unit. 3 Check the appropriate box in the General inspection results form.

Caution

! 6

Only use genuine ResMed spare parts, because the filter affects the flow characteristics of the flow generator, which in turn affects the pressure supplied to the patient.

DC power test 1 Turn off the flow generator at the mains. 2 Connect the DC-12 converter into the flow generator. 3 Connect the converter to a DC power source (12V battery or bench top power supply capable of supplying 3 amps or more). 4 Turn on the unit and confirm that the unit powers up. 5 Turn off the unit, remove the DC 12 converter, and reconnect it to mains power. 6 Check the appropriate box in the General inspection results form.

7

Keypad test 1 Switch the flow generator back on. Wait for the Welcome message to appear and check that the LEDs beneath the keypad are illuminated. Note:

The LEDs may not be clearly visible in bright light.

2 Press the Left key to enter the patient menu. Use the Up and Down buttons to cycle through the menu and the Left and Right keys to set and change options. Confirm that all button presses produce the appropriate response. 3 Press the start button and confirm that the flow generator starts. Press the button again and confirm that the flow generator stops. 4 Record the results by checking the appropriate box in the General inspection results form. If the flow generator fails this test, replace the keypad by following the procedures given in Section 5 Replacing major subassemblies. Once the keypad has been replaced, repeat the keypad test procedure. If the unit continues to fail check the contacts on the main PCB.

8

H3i test The S8 Elite/AutoSet is designed to integrate with the HumidAire 3i heated humidifier to form a single flow generator with humidification unit. The flow generator automatically detects the H3i docking station when it is connected to the flow generator.

Warning

!

12

The HumidAire 3i can reach a maximum temperature of 85°C. 1 Switch off the flow generator.

S8™ Elite/AutoSet Service Manual

2 With the front muffler assembly removed, attach the H3i to the flow generator, as shown below:

3 Switch the flow generator on and observe the LCD screen. After a Welcome message is displayed, the LCD should display the warm-up feature prompt. If the Mask fit screen is displayed, press the Right key to exit.

4 Turn the control dial to five (IIIII). 5 Press the Right key to start the H3i warming up. Ensure the light on the humidifier turns on to indicate the unit is warming.

Humidifier light

Note:

It may be difficult to determine if the humidifier light is on in a brightly lit room. 3 General inspection and servicing

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6 Press the Right key again to stop the warm-up feature. 7 Switch off the flow generator and remove the H3i docking station.

Warning

!

The heater plate will be extremely hot. 8 Switch on the flow generator and observe the LCD screen. Confirm that the warm-up feature prompt is not displayed on the screen. 9 Check the appropriate box in the General inspection results form.

9

Data card test 1 With the flow generator switched on, insert the data card into the flow generator, as shown below:

2 The LCD should briefly display the message:

3 Wait for the prompt to remove the card. 4 Remove the data card and confirm that the unit returns to the Standby screen. 5 Check the appropriate box in the General inspection results form.

10 Pressure calibration test Caution

!

Make sure the flow generator has been warmed up for at least 15 minutes before proceeding with the remaining tests. 1 With the unit unplugged from the wall, remove the data card module. 2 Connect the S8 serial adaptor to the flow generator. Press upwards and hold the button on the adapter, while pushing it onto the unit. 3 Turn on the flow generator and allow it to complete the self test. 4 Connect the flow generator to the computer via the null modem cable. 5 Select Performance Tests>Pressure calibration test from the main window, or press the Perform the pressure calibration test icon.

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S8™ Elite/AutoSet Service Manual

6 Set up the test equipment as instructed by the test software. 7 Select Next and follow the steps as instructed. If the flow generator fails this test, follow the procedures outlined in Section 7 Calibration procedures to do a full recalibration of the flow generator, ensuring the equipment set-up is correct.

11 Flow calibration test 1 Select Performance Tests>Flow calibration test from the main window, or press the Perform the flow calibration test icon. 2 Follow the steps as instructed. If the flow generator fails this test, follow the procedures outlined in Section 7 Calibration procedures to do a full recalibration of the flow generator, ensuring the equipment set-up is correct.

12 SmartStop test 1 Select Performance Tests>SmartStop test from the main window, or press the Perform the SmartStop test icon. 2 Follow the steps as instructed. If the flow generator fails this test, follow the procedures outlined in Section 7 Calibration procedures to do a full recalibration of the flow generator, ensuring the equipment set-up is correct.

13 Blower test 1 Select Performance Tests>Blower test from the main window, or press the Perform the blower test icon. 2 Set up the test equipment as instructed by the test software. 3 Select Next and follow the steps as instructed. If the flow generator fails this test, follow the procedures outlined in Section 7 Calibration procedures to do a full recalibration of the flow generator, ensuring the equipment set-up is correct.

14 LCD test 1 Select Performance Tests>LCD test from the main window, or press the Perform the LCD test icon. 2 Follow the steps as instructed. If the flow generator fails this test, refer to Section 8 Troubleshooting guide.

15 Audible alarm test 1 Select Performance Tests>Audible alarm test from the main window, or press the Perform the audible alarm test icon. 2 Follow the steps as instructed. If the flow generator fails this test, refer to Section 8 Troubleshooting guide.

3 General inspection and servicing

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16 Reload clinical settings 1 Select Settings>Flow generator settings from the main window. 2 Select File>Read settings from file, or select the folder icon. 3 Locate the settings file saved at the beginning of the General inspection and servicing procedures. 4 Open the settings file. 5 Once the settings are displayed on the screen, click the Set button to upload them to the flow generator. 6 Close the Flow generator settings window. 7 Check the Completed box in the General inspection results form.

17 Set clock Note:

Ensure that the PC used to service the flow generator is set to the correct date and time prior to pressing the Set time and date icon.

1 Select Settings>Set time and date from the main window, or press the Set time and date icon. 2 The following window will appear:

3 Select the appropriate time zone for the owner of the flow generator, then press the Locale button. 4 Check that the displayed flow generator time and date are the same as that shown in the "Set New Time and Date" frame. 5 If the details displayed are not correct, adjust the time and date using the scroll buttons, then press the Set button. 6 Close the Set Time and Date window. 7 Check the Completed box in the General inspection results form.

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S8™ Elite/AutoSet Service Manual

18 Complete the Record of Service form 1 Check the Clean flow generator box to indicate if the unit was cleaned according to the procedures outlined in step 1 Clean the flow generator.

2 Save the Record of Service form and close the service software. 3 Remove the S8 adapter. Press upwards and hold the button on the adapter whilst pulling it away from the unit. 4 Refit the Data card module to the rear of the unit.

19 Fill out product problem report 1 If any problems are found with the flow generator, fill out the Service request form in Appendix A of this manual, and send it to ResMed in Sydney for review and logging. (The address may be found on the first page of this manual.) 2 Check the Complete product problem report box in the General inspection results form. 3 Save the file. If a hard copy of the form is needed, press the Printer icon at the top of the window. 4 Close the Record of Service window.

3 General inspection and servicing

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4

Operator safety and static precautions

Warning

!

Prior to disassembly or assembly, make sure that the power is not connected to the flow generator. Integrated circuits (ICs) within the various PCBs can be badly damaged by electrostatic discharge or transient voltages. The following procedures are recommended to avoid component damage: 1 Work benches where handling and repairs are done must have surfaces of suitable conducting material connected via a 1 MΩ resistor to an electrical ground. 2 The area under and also in front of the work bench must be coated with a suitable conductive floor paint, or alternatively covered with a conductive floor mat. The conductive paint coating or floor mat must be connected to an electrical ground. 3 Soldering irons or solder baths must be at the same reference (ground) potential as the work bench. 4 A wrist strap must be worn by service personnel working at the bench. The wrist strap must have a conductive lead (1 MΩ) connected to the bench surface. Alternatively, a heel grounding strap to ground the operator to the floor may be used. (Such a wrist or heel strap should not create an electrical hazard for the wearer). 5 Handling of ICs should be kept to a minimum. If handling is required, avoid directly touching the leads. The recommended procedure is to first touch the container in which the ICs are stored, or the PCB in which they are mounted, before touching the ICs. Service personnel should take every precaution that the items will see the same reference potential when moved. 6 All ICs and PCB assemblies containing ICs should be stored in antistatic bags until use. 7 Service personnel should wear clothing which minimizes the build up of static charges. Cotton is preferable to wool or synthetic fibres. 8 Service personnel should avoid electrostatic build up through the movement of air over plastic material. 9 Plastic materials should wherever possible be kept away from the ICs as they develop and maintain high levels of static charge. 10 Low humidity increases potential static problems. Maintaining humidity levels above 60% is one of the most effective ways to guard against static handling problems.

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S8™ Elite/AutoSet Service Manual

5

Replacing major subassemblies This section contains brief instructions and points to be aware of as you replace major subassemblies and reassemble the flow generator.

Caution

!

When the main PCB, flow meter or motor is replaced, the flow generator must be recalibrated and tested. Follow the procedures in Section 7 Calibration procedures to calibrate the unit, then repeat tests 6-19 in Section 3 General inspection and servicing. Printed circuit boards can be damaged by static electricity. Please read the instructions in Section 4 Operator safety and static precautions before attempting to replace any PCBs. Thread cutting screws are used throughout the flow generator. When replacing a thread cutting screw, turn the screw anti-clockwise until it fits into the previously cut thread, otherwise the original thread may be stripped out.

Outer components of the S8 Elite/AutoSet Handle

Interface panel Filter

Air outlet Top case Bottom case

Rear view

Data card module Filter

DC input AC input

5 Replacing major subassemblies

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