SLE SLE4000 Model B User manual

SLE4000
Model C service manual
Version 4.1 to 4.3.2 software

Page 2 (Model C)
Software/Manual application Information:
Contact Information:
All rights reserved. No part of this publication may be reproduced, stored in any retrieval system, or transmitted
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: [phone]
Fax: [phone]
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.

(Model C) Page 11
Principles of Operation

Page 12 (Model C)
2. Principles of Operation
The SLE4000 infant ventilator consists of an electronic system in the upper section of the
ventilator and a pneumatic system in the lower.
2.1 Electronic System
The electronic system comprises three autonomous subsystems, one responsible for
monitoring the patient, one responsible for controlling the valves of the pneumatic system
and one for the user interface (touchscreen and displayed data). They are connected
together by three serial communication links in a delta configuration.
The ventilator has an internal battery that can power the ventilator in the event of a mains
power fail. If the mains power fails with the battery fully charged, then operation will continue
for 30 to 60 minutes depending on ventilation mode.
See “Electrical Block Diagram” on page 200.

(Model C) Page 13
2.2 Pneumatic System
The pneumatic system comprises of the tubing and electro-mechanical valves necessary to
provide the gas in conventional ventilation modes. The two gas controlling functions are
blending and pressure generation
2.2.1 Blending
The method used for blending air and oxygen in known proportions is to pressure regulate
the two supplies (air and oxygen) so they produce equal flow rates and then allow each
supply into a mixing chamber for a time period equivalent to the proportions required. For
example, delivering oxygen at a set flow rate into a mixing chamber for 1 second and air at
the same flow rate for 2 seconds will result in a mixture of 1 part oxygen to 2 parts air
(resulting in a mix of 47.3%).
2.2.2 Pressure Generation
There are three nozzles within the exhalation block in the pneumatic subsystem. One for
generating negative pressure in the patient circuit and the other two for generating positive
pressure. The positive pressures nozzles are controlled by two electronically controlled
pressure regulators. The negative nozzle is controlled by an electronically controlled
solenoid valve.
The other positive nozzle (the mean jet) is used to generate steady pressures in ventilation
(CPAP or PEEP pressures). These three nozzles (or jets) are used in various combinations
to generate all ventilation modes.
2.2.3 Conventional ventilation
The negative (or reverse) jet is used in a steady mode to provide a small amount of flow to
offset the inadvertent patient circuit pressure generated from the fresh gas flow of 8 lpm. The
mean jet is also used in a steady mode to generate the base pressure level (CPAP or PEEP)
and the forward jet is used to generate the PIP pressure during the inspiratory phase. The
rise time of the inspiratory phase is controlled by dynamically controlling the forward jet
pressure regulator.
This provides a smooth rise in pressure and allows user adjustable rise times. The fall of the
inspiratory wave is also controlled by the forward jet pressure regulator to bring the pressure
down quickly and smoothly. Once the pressure has been brought close to the base pressure,
after about 100 ms, the forward jet solenoid is switched off to prevent any further artefact
causing false triggering.
Note that all jet pressures actually sum in the exhalation block, for example, to ventilate a
patient with a PEEP pressure of 5 mbar and a PIP pressure of 30 mbar, the mean jet will be
set to generate a continuous circuit pressure of 5 mbar and the forward jet will be set to
generate a circuit pressure varying between zero (exp phase) and 25 mbar (insp. phase).
Since the jet pressures will sum, this will result in the desired patient pressure.
See “Pneumatic Unit Schematic” on page 202.

Page 14 (Model C)
This page is intentionally blank.

(Model C) Page 15
Description of Symbols

Page 16 (Model C)
3. Description of Symbols
Symbol Description
Type BF connection (Situated on front panel)
Type B device (Situated on rear panel)
Read manual (Situated on rear panel)
Date of Manufacture (Appears on serial number label)
Do not dispose of as general waste (WEEE directive).
(Appears on serial number label).
EEC conformity marking showing compliance with the Medical
Devices Directive (Appears on serial number label)
Power Off
(Embossed on power switch)
Power ON
Indicates the mains power switch
Heavy, Lift with care (Situated on rear panel)

(Model C) Page 17
Mains/Battery power indicator (Situated on front panel)
Indicates a warning in the manual
Observe anti static precautions
Indicates a note in the manual
Indicates a caution in the manual
Check list item.
Symbol Description

Page 18 (Model C)
This page is intentionally blank.

(Model C) Page 19
Equipment List

Page 20 (Model C)
4. Equipment list
To service the SLE4000 infant ventilator the service personnel will require the following
equipment. Items marked with an SLE part number can be obtained by contacting the
service department.
•Electronic engineers tool kit.
•a/b Calibration analyser (calibrated in mbar) .......SLE Part Nº: N2830
•a Patient circuit ....................................................SLE Part Nº: BC5188/100 or /400
•a Humidification chamber (Typically MR225) ......SLE Part Nº: N3220
•b Test lung ...........................................................SLE Part Nº: N6647
•cFoam support pad
•a Digital Multimeter (1mv resolution)
•aCalibration kit....................................................SLE Part Nº: N9025
Which contains the following:
Block and leak Y piece assembly Qty 1
Flow tubing assembly ................ Qty 1
Internal pressure tubing kit ........ Qty 1
Y piece Kit .................................. Qty 1
Dummy load kit .......................... Qty 1
Tygon tubing 3/8" x 9/16" ........... Qty 600mm
•cStatic protection wrist band
•cAnti-static protective bags (300mm x 300mm)
•a Flow sensor cable.............................................SLE Part Nº: N6656
•a Flow sensor ......................................................SLE Part Nº: N5301 & N5401
•a Exhalation block ...............................................SLE Part Nº: N6622
•a Oxygen supply
•a Air supply
•a Earthing strap
aNote all items marked with an ‘a’ are required for servicing and overhaul. Without these
items the user will be unable to service or overhaul the SLE4000 ventilator.
bNote items marked with a ‘b’ are required to carry out the functional testing routine.