SLE SLE4000 Model B Manuel utilisateur

SLE4000

Model C service manual

Version 4.1 to 4.3.2 software

Page 2 (Model C)

Software/Manual application Information:

Contact Information:

in any form or by any means, electronic, mechanical, photocopy, recording or otherwise, without prior

permission of SLE. © Copyright SLE 21/06/2011.

Manual : SM0022 Issue 4

SLE Part Nº: N6645/C

Note: This manual is to be used only with model C ventilators using the following

software version:

Version 4.1 to 4.3.2

SLE Limited

Twin Bridges Business Park

232 Selsdon Road

South Croydon

Surrey CR2 6PL

Telephone: +44 (0)20 8681 1414

Fax: +44 (0)20 8649 8570

E-mail: [email protected] (E-mail’s should be addressed to the Service Manager)

Web site: www.sle.co.uk

(Model C) Page 3

Contents

1. Warnings and Cautions ............................................................................................. 8

1.1. Warnings ........................................................................................................ 8

1.2. Cautions ......................................................................................................... 9

2. Principles of Operation .............................................................................................. 12

2.1. Electronic System........................................................................................... 12

2.2. Pneumatic System ......................................................................................... 13

3. Description of Symbols ............................................................................................. 16

4. Equipment list ........................................................................................................... 20

5. ENGMODE ............................................................................................................... 22

5.1. Accessing the Calibration Programs .............................................................. 22

5.2. Ventilator Calibration Program ....................................................................... 24

5.3. O2& Flow System Calibration........................................................................ 25

5.4. Reset Elapsed Time ....................................................................................... 26

5.5. Language Selection........................................................................................ 26

5.6. Activation of Language Selection Program form User Interface..................... 27

5.7. Exit ................................................................................................................. 27

5.8. Touch Screen Calibration Program ................................................................ 28

6. Component Replacement Procedure ........................................................................ 30

7. Preparing the SLE4000 ............................................................................................. 31

8. Component Replacement (Electronic unit) ............................................................... 33

8.1. Compact Flash Card (Part of N6631/21 PC board)........................................ 33

8.2. N6631/21 PC Board ....................................................................................... 33

8.3. N6634 CAN Card ........................................................................................... 34

8.4. N6631/06 Serial controller (Touch screen)..................................................... 34

8.5. L0275 Computer/Display Control assembly ................................................... 35

8.6. A0763/4B Control/Monitor Board.................................................................... 36

8.7. M0900 Power Supply Unit.............................................................................. 37

8.8. M0901 Batteries ............................................................................................. 38

8.9. A0761 Transducer PCB Assembly................................................................. 39

8.10. N6631/13 Inverter PCB ................................................................................ 40

8.11. N6631/02 LCD & N6631/05 Touch Screen .................................................. 41

9. Component Replacement (Pneumatic unit) .............................................................. 43

9.1. N2185/05 & 06 Duckbill and conical filters. .................................................... 43

9.2. L0287 Blender Assembly ............................................................................... 44

9.3. N2195/06 SV7 fresh gas supply solenoid....................................................... 45

9.4. N6612 FR7 flow regulator............................................................................... 46

9.5. N6615/01 PR1 input air regulator................................................................... 47

9.6. N6615/02 PR2 Input Oxygen Regulator......................................................... 49

9.7. L0289 Pressure regulator module .................................................................. 52

9.8. N2181 PR5 regulator...................................................................................... 54

9.9. N6623/S38 PR4 & PR6 pressure regulators .................................................. 55

9.10. N2195/16 SV13 solenoid.............................................................................. 57

Page 4 (Model C)

10. A0763/4B Monitor and control board .......................................................................60

10.1. A0763/4B board progammable devices........................................................60

10.2. A0763/4B Board Hardware Identifier ............................................................61

11. Electrical Safety Testing of the SLE4000 ................................................................65

12. PSU Testing ............................................................................................................69

13. Maintenance and Overhaul .....................................................................................72

13.1. Preventative Maintenance ............................................................................72

13.2. 12 & 36 month preventative maintenance procedure ...................................74

13.3. 24 month and 48 month overhaul procedures ..............................................82

13.4. 24 month / 10,000 hour overhaul procedure.................................................84

13.5. 48 month / 20,000 hour overhaul procedure.................................................91

13.6. 48 month overhaul procedure using N9410/48 overhaul kit. ........................93

14. Calibration Procedure for V4.1 to 4.3.2 software ....................................................104

14.1. Preliminary Inspection before calibration ......................................................104

14.2. Pneumatic set up ..........................................................................................105

14.3. Calibration of Controller and Monitor subsystems ........................................106

14.4. Controller “Block and Leak” pressure sensor calibration ..............................108

14.5. Controller Blender Pressure Sensor zeroing and Input pressure reg. trim ...109

14.6. Mean Jet Pressure Regulator Calibration .....................................................110

14.7. Forward Jet Pressure Regulator Calibration.................................................111

14.8. Wave shaping for leading and trailing edge of insp. phase ..........................112

14.9. O2System Calibration ..................................................................................113

14.10. Flow System Calibration .............................................................................113

14.11. Pressure Triggering Verification..................................................................113

14.12. Gas Fail Detection Verification....................................................................114

14.13. Blender and Oxygen Monitoring Verification...............................................115

14.14. Soak Test....................................................................................................116

14.15. Battery Charge Verification .........................................................................117

14.16. Battery Life Verification ...............................................................................117

14.17. Total Power Fail Alarm Test........................................................................117

14.18. Pressure Calibration Verification.................................................................118

15. Functional Testing ...................................................................................................120

15.1. Ventilator setup .............................................................................................120

16. Trouble Shooting Chart ...........................................................................................148

17. Software Version History .........................................................................................156

18. Oxygen Calibration Routines ...................................................................................158

18.1. One point or 100% Oxygen system calibration.............................................158

18.2. Two point or 21% & 100% Oxygen system calibration .................................158

19. Alarms .....................................................................................................................160

19.1. Alarm Protocols.............................................................................................160

19.2. Alarm Sounds ...............................................................................................160

19.3. Alarm Descriptions and actions to be taken..................................................161

19.4. Software and System Fail Protocols .............................................................180

(Model C) Page 5

20. Cleaning, disinfection and sterilization .................................................................... 181

20.1. Preparation of a new ventilator..................................................................... 181

20.2. Cleaning and disinfection of an in-service ventilator .................................... 181

20.3. Cleaning method .......................................................................................... 182

20.4. Disinfection method...................................................................................... 183

20.5. Sterilization method ...................................................................................... 184

21. Technical Specification ........................................................................................... 185

21.1. Operating Modes Conventional Ventilation .................................................. 185

21.2. Measurement ............................................................................................... 190

21.3. Exhalation Block Port Jet Sizes.................................................................... 191

21.4. Alarms .......................................................................................................... 192

21.5. Patient circuits .............................................................................................. 193

21.6. Outputs......................................................................................................... 194

21.7. Gas supplies................................................................................................. 195

21.8. Power, Dimensions, Standards etc. ............................................................. 196

21.9. Environmental Storage Conditions............................................................... 196

22. Ventilator labelling ................................................................................................... 197

22.1. SLE4000....................................................................................................... 197

23. Electrical Block Diagram ......................................................................................... 200

24. L0288 Pneumatic Unit Layout ................................................................................. 201

25. Pneumatic Unit Schematic ...................................................................................... 202

25.1. Schematic..................................................................................................... 202

26. Pneumatic Unit Tubing connections ....................................................................... 203

27. Main Loom Circuit Diagram .................................................................................... 204

28. A0761 circuit diagram ............................................................................................. 206

28.1. Transducer PCB Assembly .......................................................................... 206

29. A0763/02 circuit diagrams ...................................................................................... 208

29.1. Micro Controller ............................................................................................ 208

29.2. Conventional Valve Drive ............................................................................. 209

29.3. Power Distribution And Hardware Identifier.................................................. 210

29.4. Analogue Valve Drive / Non Volatile Memory / Interboard Comms.............. 211

29.5. High Speed Valve Drive ............................................................................... 212

29.6. Analogue Data acquisition/Monitor port........................................................ 213

29.7. Control & Monitor, PCB PSU Circuit............................................................. 214

29.8. Control & Monitor, Micro Non-isolated.......................................................... 215

29.9. Control & Monitor, Micro Isolated ................................................................. 216

29.10. Control & Monitor, Analog Isolated............................................................. 217

29.11. Control & Monitor, Alarm Controller............................................................ 218

30. Illustrated Parts List ................................................................................................ 220

Ventilator assembly .............................................................................................. 222

Base plate and side door assembly ...................................................................... 229

Front facia assembly ............................................................................................ 231

Page 6 (Model C)

Electronic module .................................................................................................233

Pneumatic module ................................................................................................253

Pressure regulator module ....................................................................................260

Oxygen regulator module ......................................................................................268

Partition assembly .................................................................................................271

Pneumatic module, sub assembly ........................................................................275

31. Equipotential stud modification ................................................................................284

31.1. Equipotential stud connection .......................................................................285

Appendix 1. Calibration Checklist ..................................................................................289

Appendix 2. Check list ...................................................................................................297

Appendix 3. TB & SI Index ............................................................................................302

32. Technical Bulletin & Service Information Letters .....................................................302

32.1. Service Information letters ............................................................................302

32.2. Technical Bulletins ........................................................................................304

Appendix 4. RS232 .......................................................................................................306

33. RS232 .....................................................................................................................306

33.1. Warnings for RS232......................................................................................306

33.2. Location of RS232 Port.................................................................................306

33.3. Overview .......................................................................................................307

33.4. Data and Pinout description..........................................................................307

33.5. Cable.............................................................................................................307

33.6. Parameter Descriptions and format ..............................................................308

33.7. List of parameters .........................................................................................308

33.8. Table of current alarm condition codes.........................................................311

33.9. RS232 Connection Settings and Testing Data Output..................................313

33.10. Glossary......................................................................................................313

Appendix 5. VueLink .....................................................................................................316

34. VueLink Technical Data ..........................................................................................316

34.1. Glossary........................................................................................................316

34.2. Connecting the SLE4000 to the VueLink patient monitor .............................316

34.3. Parameter Descriptions ................................................................................317

34.4. Data transferred to the VueLink system from the SLE4000..........................318

34.5. Alarm and inoperative indications .................................................................320

34.6. VueLink Task Window Layout.......................................................................323

34.7. Notes on General System Behaviour............................................................324

34.8. Activation of VueLink ....................................................................................325

34.9. Disabling VueLink. ........................................................................................326

(Model C) Page 7

Warnings and Cautions

Page 8 (Model C)

1. Warnings and Cautions

1.1 Warnings

1. The electronic and pneumatic units of the SLE4000 infant ventilator are sealed at the

factory with two Warranty Void If Label Broken seals. If the ventilator is subject to a

warranty agreement do not attempt to carry out any procedure that would involve

breaking these seals. If you make a warranty claim and these seals are broken SLE

may deem the warranty claim null and void. If the ventilator develops a fault within the

warranty period please refer to your warranty documentation.

2. Oxygen - Fire Hazard. Oxygen vigorously supports combustion and its use requires

special precaution to avoid fire hazards. Keep all sources of ignition away when oxygen

is in use. Do not use oil or grease on oxygen fittings or where oxygen is used.

3. Check the condition of the gas supply hoses to the ventilator. Do not use any hose that

shows signs of cracking, abrasion, kinking, splits, excessive wear or ageing. Make sure

that the Air or O2hose has not come into contact with oil or grease.

4. The SLE4000 ventilator contains temperature dependant devices which perform

normally in controlled environments in hospitals. However if the ventilator has been

stored at a temperature different to that in which it will be used, allow the unit to

acclimatize before powering up.

5. Failure to comply with the recommended service programs could lead to injury of the

patient, operator or damage to the ventilator. It is the owners responsibility to ensure

that the equipment is regularly maintained.

6. The SLE4000 contains static sensitive electrical devices. Anti static precautions must be

observed at all time when working on the ventilator.

(Model C) Page 9

1.2 Cautions

1. When working on the pneumatic unit, protect the front facia panel by resting it on a soft

pad.

2. Do not use a sharp instrument, such as a pen to activate the controls as the excessive

pressure applied by the point will damage the touch screen membrane.

3. The Ventilator must be connected to a suitably rated and grounded electrical power

source.

4. If the SLE4000 is adversely affected by equipment emitting electromagnetic interference

then that equipment should be switched off or removed from the vicinity of the SLE4000.

Conversely, if the SLE4000 is the source of interference to other neighbouring

equipment, it should be switched off or taken to another location.

5. The functioning of this machine may be adversely affected by the operation of

equipment such as high frequency surgical (diathermy) equipment, defibrillators, mobile

phones or short-wave therapy equipment in the vicinity.

7. The equipment is not suitable for use with, or in the presence of flammable anaesthetic

mixtures.

6. The SLE4000 flow monitoring system is calibrated to work in an air / oxygen mixture, the

use of other gas mixtures may affect the flow monitoring accuracy of the ventilator.

7. Disposal of the Oxygen Sensor Cell should be in accordance with local regulations for

hazardous substances. Do not incinerate. SLE offer a cell disposal service.

8. The SLE4000 contains several batteries, three 2 cell sealed lead acid batteries, one

PCB mounted lithium battery and 2 AA alkaline batteries. At the end of their useful life

these batteries should be disposed of in accordance with local authority guidelines.

9. Apart from the batteries, the ventilator and accessories do not contain any hazardous

components therefore no special precautions are required for their disposal. The

ventilator should be disposed of in accordance to the local WEEE (Waste Electrical and

Electronic Equipment) guidelines.

10. Care should be taken when attaching other equipment as this may affect mechanical

stability.

11. Any computer connected to the ventilator must be specified for medical use (i.e. it must

comply with the requirements of BS-EN-60601:1990).

Page 10 (Model C)

12. There is no special protection provided against ingress of water or liquids.

13. Do not use solvent based cleaning solutions to clean the touch screen or covers.

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