S8 Elite and AutoSet Service Manual Oct 2010

Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Distributed by: ResMed Corp 9001 Spectrum Center Blvd. San Diego CA 92123 USA ResMed (UK) Ltd (EU Authorised Representative) 96 Milton Park Abingdon Oxfordshire OX14 4RY UK See www.resmed.com for other ResMed locations worldwide. Protected by patents: AU 691200, AU 697652, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU 750761, AU 764761, AU 779327, AU 2002231456, CN 02804930.6, EP 0651971, EP 0661071, EP 0920845, EP 0934723, EP 1028769, EP 1126893, EP 1502618, EP 1144036, JP 3580776, JP 3778797, NZ 504595, NZ 544765, NZ 570415, US 5704345, US 6138675, US 6240921, US 6363933, US 6367474, US 6425395, US 6502572, US 6591834, US 6745768, US 6817361, US 6988498, US 7040317, US 7100608. 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 200430121213.7, CN 200430121211.8, CN 200430121214.1, CN 200430121215.6, CN 200430121216.0, CN 200430121217.5, CN 200730324758.1, CN 200730324759.6, CN 200730324763.2, CN 200730324765.1, CN 200730324779.3, CN 200730324781.0, EU 269436, EU 815071, HK 0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP 1267270, JP 1267271, JP 1341816, JP 1338974, JP 1338975, JP 1339123, JP 1339124, JP 1339125, JP 1339126, JP 1338546, JP 1341954, JP 1338670, JP 1338973, NZ 405614, NZ 406923, NZ 406924, NZ 406925, NZ 406926, NZ 406927, NZ 406928, NZ 409901, NZ 409903, NZ 411472, NZ 411471, NZ 411552, NZ 411553, NZ 411554, NZ 411555, NZ 411556, NZ 411557, NZ 411558,US D544598, US D553228, US D557406, US D557407, US D560795, US D561891, US D565160, US D577807, US D578204, D585131, US D585540, US D589136, US D589137, US D589138, US D590494, US D614286. Others pending. S8, S8 AutoSet, S8 Elite and SmartStart are trademarks of ResMed Ltd and AutoSet and HumidAire are registered in U.S. Patent and Trademark Office.

© 2010 ResMed Ltd.

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Contents 1

How to use this manual ... 4

2

Introduction ... 5 Intended users of this manual

5

Features of the flow generators Product History

5 5

Software history

3

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

7

Equipment required 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 H4i test 8 Data card test 9 Pressure calibration test 11 Flow calibration test 12 SmartStop test 12 Blower test 13 Keypad test 14 LCD test 15 Audible alarm test 16 Finalise manual check results 17 Set clock 18 Reload clinical settings 19 Fill out product problem report

7 7 8 8 11 11 11 12 12 13 14 15 15 15 15 15 15 16 16 17 18

4

Operator safety and static precautions ... 19

5

Replacing major subassemblies ... 20 Outer components of the S8 Elite II/AutoSet II 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 Examining the motor Installing the motor Replacing the power supply Replacing the flow sensor

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

2

6

S8™ Elite II, S8 AutoSet™ II Service Manual

20 21 21 21 23 25 27 28 29 31 33 35

38 40

6

Replacement parts list ...41 Outside cases Also available Interface assembly Internal components PCBs

Spare parts list

7

41 41 42 42 44

45

Calibration procedures ...47 1 2 3

Equipment required Pressure calibration Flow calibration Motor noise calibration

47 47 48 48

8

Troubleshooting guide ...49

9

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

53

10 Recommended maintenance schedule ...54 Appendix A: Service request form ...55 Appendix B: Operational diagram ...56

Contents

3

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 II/AutoSet II. 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 II/AutoSet II 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. Appendix A: Service Request Form - Fill out this form if you need to return a device to ResMed for servicing. Appendix B: Operational diagram - Provides a functional block diagram of the S8 Elite II/AutoSet II flow generator. 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. 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 II, S8 AutoSet™ II Service Manual

2

Introduction This manual is a guide to servicing and repairing the range of S8 Elite II and S8 AutoSet II flow generators. 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.

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.

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

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

Product History Upon the original release of the S8 Elite II/AutoSet II products only the US versions of the units included Expiratory Pressure Relief (EPR) with the Easy-Breathe waveform (EBW). The latest release of S8 Elite II/AutoSet II products across all regions (except Japan) include EPR with EBW, and new product numbers for those products have been issued (except for the ANZ region which has retained the original product code). The product codes for the original release and EBW release of products are as follows: Americas 33039 - S8 Elite II 33129- S8 AutoSet II Germany 33043 - S8 Elite II

33075 - S8 Elite II EBW

33134 - S8 AutoSet Spirit II

33147 - S8 AutoSet Spirit II EBW

France 33040 - S8 Elite II

33072 - S8 Elite II EBW

33132 - S8 AutoSet Spirit II

33145 - S8 AutoSet Spirit II EBW

EUR G1 33042 - S8 Elite II

33074 - S8 Elite II EBW

33130 - S8 AutoSet Spirit II

33143 - S8 AutoSet Spirit II EBW

2 Introduction

5

EUR G2/APAC 33041 - S8 Elite II

33073 - S8 Elite II EBW

EUR G2 33135 - S8 AutoSet Spirit II

33148 - S8 AutoSet Spirit II EBW

APAC 33131 - S8 AutoSet Spirit II

33144 - S8 AutoSet Spirit II EBW

Japan 33138 - S8 AutoSet (Teijin) 33137 - S8 AutoSet Respond (Fukuda) ANZ 33044 - S8 AutoScore II 33136 - S8 AutoSet Spirit II UK 33133 - S8 AutoSet Spirit II

33146 - S8 AutoSet Spirit II EBW

The new release products that feature EPR with EBW can be identified by the EPR label on the interface panel, circled below (except in ANZ units):

Software history The software history of the S8 Elite II/AutoSet II products are as follows: US SX480-0100

Original release

SX480-0101

Maintenance upgrade

SX442-0200

Original release

SX480-0210

Maintenance upgrade

SX480-0101

Upgrade to EBW (same as current US version)

ROW

Note:

6

If the flow generator main PCB needs to be replaced, ensure the correct PCB is installed. If an original release unit (without EBW) needs a new PCB, ensure the replacement board has the appropriate software. Spare part main PCBs with EBW are not backward compatible.

S8™ Elite II, S8 AutoSet™ II 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 II/AutoSet II is in good electrical and mechanical condition. These tests will highlight any major mechanical or electrical problem with the unit.

Equipment required • ResMed Service Software 1.20 (19924) or available in service software kit #19923. (Software kit #19923 contains - S9 USB adapter and cable, oxygen sideport connector, straight adapter, calibration cap and air tubing connector.) Note:

Ensure you check the Technical Services website to confirm the latest version of service software available for use with this product.

• • • •

ResScan USB adaptor and cable (ResMed part #22203)

• • • • •

DC-12 converter (ResMed part# 33942)

Oxygen side port connector (ResMed part #14915) Straight adaptor (ResMed part #19375) Calibration adaptor kit - contains calibration cap, air tubing connector and oxygen sideport connector (ResMed part #19911)

H4i docking station Data card 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 XP or Vista (32-bit). Function keys

LCD screen Up key Left key

Right key

Down key Start/Stop key

3 General inspection and servicing

7

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.

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 ResScan USB adaptor to the flow generator. Press upwards and hold the button on the adaptor, 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 PC via the USB cable.

USB cable ResScan USB adaptor

8

S8™ Elite II, S8 AutoSet™ II Service Manual

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

XPlorer bar

Refresh button

7 Press the Refresh button (as indicated above) to enable the service software to recognise the flow generator. 8 The flow generator details will then be displayed at the bottom of the screen beside the Refresh button. The calibration and tests in the Xplorer bar at the left of the screen will also change to indicate the procedures specific for that product. 9 Select Flow Generator Settings... in the XPlorer bar, or click on the Flow Generator Setting Dialog icon

at the top of the screen.

10 Note: It will take a few seconds for the flow generator settings to be displayed. 11 The flow generator settings will be displayed as shown below:

12 Select Save to Database in the XPlorer bar.

3 General inspection and servicing

9

13 The service history dialog will then be displayed if the unit has existing records in the application database. (If there are no existing records, proceed to step 14.) Click on the Create a new Service Setting Record icon to start a new session, or select an existing session from the service history displayed:

Create a new Service Setting Record icon

14 The following window will then appear:

15 At this point, you can select the name of the service agent handling the device and enter the Service Record (SR) and Repair numbers, so that this information will be included with the flow generator settings details. Note:

To enter new service agent details, click on the image in the "Select service agent" window. A cursor will then appear in the "Service Agent" field, and the name can be entered. Once the service agent details are entered, any service agent names entered for that device will be available for selection in the drop down menu. If an existing session was selected, the "Select service agent" window will already be populated.

Warning

!

If the clinical settings cannot be recorded, select the appropriate product code for the product. In the XPlorer bar, click on "Read default settings", then click on "Reload to flow generator". Notify the patient, so they can have their settings reloaded. 16 Click on the Select button once the details have been entered. 17 The software will then return to the settings screen. 18 Turn off the flow generator and disconnect the serial adapter. 19 Refit the data card module.

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S8™ Elite II, S8 AutoSet™ II Service Manual

3

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.

4 Warning

!

Internal examination (if necessary) The VPAP range 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 6-17 in Section 3 General inspection and servicing. Reassemble the flow generator.

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.

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.

Caution

!

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. 3 General inspection and servicing

11

6

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.

7

H4i test The S8 Elite II/AutoSet II is designed to integrate with the H4i heated humidifier to form a single flow generator with humidification unit. The flow generator automatically detects the H4i docking station when it is connected to the flow generator.

Warning

!

The H4i can reach a maximum temperature of 85°C. 1 Switch off the flow generator. 2 Remove the power outlet plug from the front of the unit. 3 Attach the H4i to the flow generator.

4 Switch on the flow generator 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.

5 Turn the control dial to five (IIIII). 12

S8™ Elite II, S8 AutoSet™ II Service Manual

6 Press the Right key to start the H4i 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.

7 Press the Right key again to stop the warm-up feature. 8 Switch off the flow generator and remove the H4i docking station.

Warning

!

The heater plate will be extremely hot. 9 Refit the power outlet plug to the front of the unit. 10 Switch on the flow generator and observe the LCD screen. Confirm that the warm-up feature prompt is not displayed on the screen. 11 Check the appropriate box in the General inspection results form.

8

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

3 General inspection and servicing

13

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.

9 Caution

!

Pressure calibration test Make sure the flow generator has been warmed up for at least 15 minutes before proceeding with the remaining tests. 1 With the unit still switched off, remove the data card module and refit the ResScan USB adaptor, with USB cable attached. 2 Turn on the unit and allow it to complete the self test. 3 Return to the service software and press the Record button

.

4 The following screen will then appear, indicating the existing service records for the flow generator.

5 The most recently created record (the flow generator settings recorded earlier) will be highlighted. 6 Click on the Select button

to continue recording the service results to the same record.

7 The "Select service agent screen", as shown on page 10, will appear once again. 8 Select the name of the service agent and enter the SR number. 9 All calibration and tests, including tests completed without service software are then listed in the Xplorer bar. 10 Select Pressure calibration test in the XPlorer bar, or click on the Perform the pressure calibration test icon Note:

14

.

At the top of the screen at the beginning of each procedure is an alert reminding you to reload the clinical settings to the unit after completing the necessary test and calibration procedure. Click the OK button once you have read the alert.

S8™ Elite II, S8 AutoSet™ II Service Manual

11 Set up the test equipment as instructed by the test software. 12 Select Next and follow the steps as instructed. 13 If the flow generator fails this test, repeat the pressure calibration, ensuring the test set-up is correct.

11 Flow calibration test 1 Select Flow calibration test in the Xplorer bar, or click on te Perform the flow calibration 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.

12 SmartStop test 1 Select SmartStop test in the Xplorer bar, or click the Perform the SmartStop 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.

12 Blower test 1 Select Blower test in the XPlorer bar, or click on the Perform the blower test icon

.

2 The test set-up remains the same as the SmartStop test. 3 Select Next and follow the steps as instructed. If the flow generator fails this test, repeat the pressure calibration, ensuring the test set-up is correct. If the unit continues to fail, refer to Section 8 Troubleshooting guide.

13 Keypad test 1 Select Keypad test in the Xplorer bar, or click on te Perform the keypad test icon

.

2 The test set-up remains the same as the blower test. 3 Select Next and follow the steps as instructed. If the flow generator fails this test, refer to Section 8 Troubleshooting guide.

14 LCD test 1 Select LCD test in the XPlorer bar, or click on 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 Audible alarm test in test in the Xplorer bar, or click on te Perform the audible alarm 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, refer to Section 8 Troubleshooting guide. 3 General inspection and servicing

15

16 Finalise manual check results In the XPlorer bar at the left of the screen, all tests that are completed without the service software are listed under the title "Manual Check".

1 Click on the name of each manual check. A screen such as that shown below will be displayed:

For each manual check, indicate whether the unit passed or failed.

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 Set time and date... in the XPlorer bar, or click on the Read and adjust flow generator clock icon

.

2 The following window will appear:

16

S8™ Elite II, S8 AutoSet™ II Service Manual

3 Select the appropriate time zone for the owner of the flow generator, then press the Locale button. 4 Press the Select button to set the flow generator time and date.

18 Reload clinical settings 1 Click on the Record button to close the current session. 2 Select Flow Generator Settings... in the XPlorer bar, or click on the Flow Generator Setting Dialog icon

at the top of the screen.

3 The flow generator settings will be displayed. 4 Select Read database, as shown below:

5 All recorded sessions for the unit will be displayed. Ensure the most recent session (in which the clinical settings and results were recorded) is highlighted, then click the Select button

.

6 The screen will then be repopulated with the original settings. Select Reload to flow generator in the Xplorer bar to load the settings back into the unit. 7 Once complete, exit the settings screen. 8 Once again, press the Record button and ensure the most recent session (in which the clinical settings and results were recorded) is highlighted, then click on the Select button

.

9 Click on Reload settings at the bottom of the Xplorer bar.

3 General inspection and servicing

17

10 The following window will be displayed:

11 Click on the Select button to indicate that the clinical settings were successfully reloaded into the flow generator. 12 Press the Record button if you did not need to fill out the product problem report or print out the test results.

19 Fill out product problem report 1 If the flow generator needs to be returned to a ResMed service centre, fill out the ResMed Service Request Form in Appendix A of this manual, and send it to your regional ResMed office along with the flow generator. 2 Once again, click on the Record button and open the session just completed. 3 At the bottom of the Xplorer bar select Complete Problem Report and click on the Pass button to indicate that problem report was completed. 4 Click the Record button to finish the session.

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S8™ Elite II, S8 AutoSet™ II Service Manual

4 Warning

!

Operator safety and static precautions 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 M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 M) 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.

4 Operator safety and static precautions

19