SLE SLE5000 Model J User manual

SLE5000
Model J service manual
Version 4.3.1 & 4.3.2 software

Page 2 (Model J)
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 30/09/2016.
Manual: SM31 Issue 3
SLE Part Nº: N6645/J
Note: This manual is to be used only with models J ventilators using the following
software version:
Version 4.3.1 & 4.3.2
SLE Limited
Twin Bridges Business Park
232 Selsdon Road
South Croydon
Surrey CR2 6PL
Telephone: [phone]
Service Fax: [phone]
E-mail: [email protected] (E-mail’s should be addressed to the Service Manager)
Web site: www.sle.co.uk
Revision history.
Issue 3: CR 371, 451 & 586. ECN167.

(Model J) Page 3
Contents
1. Warnings and Cautions .............................................................................................10
1.1. Warnings ........................................................................................................10
1.2. Cautions .........................................................................................................11
2. Principles of Operation ..............................................................................................14
2.1. Electronic System...........................................................................................14
2.2. Pneumatic System .........................................................................................15
3. Description of Symbols .............................................................................................18
4. Equipment list ...........................................................................................................22
5. ENGMODE ...............................................................................................................24
5.1. Accessing the Calibration Programs ..............................................................24
5.2. Ventilator Calibration Program .......................................................................26
5.3. O2 & Flow System Calibration........................................................................27
5.4. Reset Elapsed Time.......................................................................................28
5.5. Language Selection........................................................................................28
5.6. Activation of Language Selection Program form User Interface.....................29
5.7. Exit .................................................................................................................29
5.8. Touch Screen Calibration Program................................................................30
6. Component Replacement Procedure ........................................................................32
7. Preparing the SLE5000 .............................................................................................33
8. Component Replacement (Electronic unit) ...............................................................35
8.1. N6631/21/CF/50 Compact Flash Card...........................................................35
8.2. N6631/LX800 PC Board.................................................................................35
8.3. N6634/OEM2 CAN Card ................................................................................36
8.4. N6631/2216 Serial controller (Touch screen).................................................36
8.5. L0275/OEM2 Computer/Display Control assembly........................................37
8.6. A0763/02/M Control/Monitor Board................................................................38
8.7. M0915 Power Supply Unit..............................................................................39
8.8. M0901 Batteries .............................................................................................40
8.9. A0761 Transducer PCB Assembly.................................................................41
8.10. N6631/13 Inverter PCB ................................................................................42
8.11. N6631/02 LCD & N6631/05 Touch Screen ..................................................43
9. Component Replacement (Pneumatic unit) ..............................................................45
9.1. Duckbill and conical filters..............................................................................45
10. A0763/02/M Monitor and control board ...................................................................56
10.1. A0763/02/M board programmable devices...................................................56
10.2. A0763/02/M Board Hardware Identifier........................................................57
11. Electrical Safety Testing of the SLE5000 ................................................................61
12. PSU Testing ............................................................................................................65
13. Ventilator Power up and Power down. ....................................................................68
14. Back-up Battery Charging .......................................................................................69

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14.1. Battery indicator............................................................................................69
15. Extended storage ....................................................................................................71
16. Maintenance and Overhaul .....................................................................................74
16.1. Preventative Maintenance Kit.......................................................................74
16.2. 12 & 36 month preventative maintenance procedure...................................76
16.3. 24 month and 48 month overhaul procedures ..............................................84
16.4. 24 month / 10,000 hour overhaul procedure.................................................86
16.5. 48 month / 20,000 hour overhaul procedure.................................................94
16.6. 48 month overhaul procedure using N9410/48/G overhaul kit......................96
17. Calibration Procedure for V4.3.1 & V4.3.2 software ................................................108
17.1. Equipment required for calibration................................................................108
17.2. Preliminary Inspection before calibration......................................................109
17.3. Pneumatic set up..........................................................................................110
17.4. Calibration of Controller and Monitor subsystems........................................113
17.5. Controller “Block and Leak” pressure sensor calibration ..............................115
17.6. Controller Blender Pressure Sensor zeroing and Input pressure reg. trim ...116
17.7. Mean Jet Pressure Regulator Calibration.....................................................117
17.8. Forward Jet Pressure Regulator Calibration.................................................119
17.9. Reverse Jet Pressure Regulator Calibration.................................................120
17.10. Time Constant for pressure measurement waveform.................................121
17.11. Wave shaping for leading and trailing edge of insp. phase ........................121
17.12. O2 System Calibration................................................................................123
17.13. Flow System Calibration .............................................................................123
17.14. Pressure Triggering Verification..................................................................123
17.15. Gas Fail Detection Verification....................................................................123
17.16. Blender and Oxygen Monitoring Verification...............................................124
17.17. Soak Test....................................................................................................125
17.18. Battery Charge Verification.........................................................................126
17.19. Total Power Fail Alarm Test........................................................................126
17.20. Pressure Calibration Verification.................................................................127
18. Functional Testing ...................................................................................................130
18.1. Ventilator setup.............................................................................................130
19. Trouble Shooting Chart ...........................................................................................162
20. Software Version History .........................................................................................172
21. Oxygen Calibration Routines ...................................................................................174
21.1. One point or 100% Oxygen system calibration.............................................174
21.2. Two point or 21% & 100% Oxygen system calibration.................................174
22. Alarms .....................................................................................................................176
22.1. Alarm Protocols.............................................................................................176
22.2. Alarm Sounds ...............................................................................................176
22.3. Alarm Descriptions and actions to be taken..................................................177
22.4. Software and System Fail Protocols.............................................................196

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23. Cleaning, disinfection and sterilization ....................................................................197
23.1. Preparation of a new ventilator.....................................................................197
23.2. Cleaning and disinfection of an in-service ventilator ....................................197
23.3. Cleaning method ..........................................................................................198
23.4. Disinfection method......................................................................................199
23.5. Sterilization method......................................................................................200
24. Technical Specification ...........................................................................................201
24.1. Operating Modes Conventional Ventilation..................................................201
24.2. HFO Ventilation............................................................................................203
24.3. Measurement ...............................................................................................207
24.4. Exhalation Block Port Jet Sizes....................................................................208
24.5. Alarms ..........................................................................................................209
24.6. Patient circuits..............................................................................................210
24.7. Outputs.........................................................................................................211
24.8. Gas supplies.................................................................................................212
24.9. Power, Dimensions, Classification etc..........................................................213
24.10. Classification ..............................................................................................213
24.11. Environmental Storage Conditions.............................................................213
25. EMC compliance .....................................................................................................214
25.1. Electromagnetic immunity ............................................................................215
25.2. Recommended separation distances between portable and mobile RF
communications equipment and the SLE5000......................................................217
26. Ventilator labelling ...................................................................................................218
27. Electrical Block Diagram .........................................................................................220
28. L0280/KV Pneumatic Unit Layout & Schematic ......................................................221
28.1. Layout ..........................................................................................................221
28.2. Schematic ....................................................................................................222
29. Main Loom Circuit Diagram ....................................................................................223
30. L0275/OEM2 Assembly Schematic ........................................................................224
31. A0761 circuit diagram .............................................................................................226
31.1. Transducer PCB Assembly ..........................................................................226
32. A0763/02 circuit diagrams ......................................................................................228
32.1. Micro Controller............................................................................................228
32.2. Conventional Valve Drive.............................................................................229
32.3. Power Distribution And Hardware Identifier..................................................230
32.4. Analogue Valve Drive / Non Volatile Memory / Interboard Comms..............231
32.5. High Speed Valve Drive ...............................................................................232
32.6. Analogue Data acquisition/Monitor port........................................................233
32.7. Control & Monitor, PCB PSU Circuit.............................................................234
32.8. Control & Monitor, Micro Non-isolated..........................................................235
32.9. Control & Monitor, Micro Isolated.................................................................236
32.10. Control & Monitor, Analog Isolated.............................................................237
32.11. Control & Monitor, Alarm Controller............................................................238

Page 6 (Model J)
33. Illustrated Parts List .................................................................................................240
Ventilator assembly ...............................................................................................242
Base plate and side door assembly ......................................................................249
Front facia assembly .............................................................................................251
Electronic module .................................................................................................253
Pneumatic module ................................................................................................273
DISS air and oxygen fittings ..................................................................................285
34. Modifications ...........................................................................................................288
34.1. Equipotential stud modification.....................................................................288
34.2. Modification A as per SI120401 - (Bypassing of oxygen volume chamber)..290
34.3. Modification 1, 2 & 4 as per EMC upgrade...................................................292
34.4. Contents of N9020/000/KIT kit......................................................................293
34.5. Equipment list ...............................................................................................293
34.6. Checking the modification status. .................................................................295
34.7. EMC upgrade procedure...............................................................................296
34.8. Modification 1 (MOD1)..................................................................................298
34.9. Modification 2 (MOD2)..................................................................................300
34.10. Modification 4 (MOD4)................................................................................301
34.11. Re-assembly and testing ............................................................................302
34.12. MOD identification.......................................................................................302
34.13. Re-assembly...............................................................................................302
Appendix 1. Calibration Checklist ..................................................................................305
Appendix 2. Check list ...................................................................................................313
Appendix 3. TB & SI Index ............................................................................................318
35. Technical Bulletin & Service Information Letters .....................................................318
35.1. Service Information letters............................................................................318
35.2. Technical Bulletins........................................................................................320
Appendix 4. ...................................................................................................................322
36. RS232 .....................................................................................................................322
36.1. Warnings for RS232......................................................................................322
36.2. Location of RS232 Port.................................................................................322
36.3. Overview.......................................................................................................323
36.4. Data and Pinout description..........................................................................323
36.5. Cable.............................................................................................................323
36.6. Parameter Descriptions and format..............................................................324
36.7. List of parameters.........................................................................................324
36.8. Table of current alarm condition codes.........................................................327
36.9. RS232 Connection Settings and Testing Data Output..................................329
36.10. Glossary......................................................................................................329
Appendix 5. VueLink .....................................................................................................332
37. VueLink Technical Data ..........................................................................................332
37.1. Glossary........................................................................................................332

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37.2. Connecting the SLE5000 to the VueLink patient monitor.............................332
37.3. Parameter Descriptions................................................................................333
37.4. Data transferred to the VueLink system from the SLE5000.........................334
37.5. Alarm and inoperative indications.................................................................336
37.6. VueLink Task Window Layout......................................................................339
37.7. Notes on General System Behaviour...........................................................340
37.8. Activation of VueLink....................................................................................341
37.9. Disabling VueLink.........................................................................................342

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(Model J) Page 9
Warnings and Cautions

Page 10 (Model J)
1. Warnings and Cautions
1.1 Warnings
1. The electronic and pneumatic units of the SLE5000 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 SLE5000 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 SLE5000 contains static sensitive electrical devices. Anti static precautions must be
observed at all time when working on the ventilator.
7. When working on the ventilator disconnect the mains supply. Use an earthing strap to
earth the ventilator.

(Model J) Page 11
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 SLE5000 is adversely affected by equipment emitting electromagnetic interference
then that equipment should be switched off or removed from the vicinity of the SLE5000.
Conversely, if the SLE5000 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.
8. The equipment is not suitable for use with, or in the presence of flammable anaesthetic
mixtures.
6. The SLE5000 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 should be in accordance with local regulations for
hazardous substances. Do not incinerate. SLE offer a cell disposal service.
8. The ventilator must have its batteries charged every 14 days. The ventilator must be
connected to a mains power source for 24 hours to ensure a full charge. Failure to
charge the batteries will shorten the service life of the batteries which will result in
reduced battery life in a mains power fail situation.
9. If the ventilator is operating on battery power and allowed to completely discharge the
battery, it should be recharged a soon as possible. This is to avoid damaging the
batteries by allowing them to remain in a deep discharged state for any period of time.
Allowing the batteries to remain in the deep discharged state will shorten the life of the
batteries and the amount of time the ventilator can remain on battery power.
10. If the ventilator is not going to be used for a period in excess of 40 days then disconnect
the batteries from the power supply. (See “Extended storage” on page 71.)

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11. The SLE5000 contains several batteries, three 2 cell sealed lead acid batteries and 2
AA alkaline batteries. At the end of their useful life these batteries should be disposed of
in accordance with local authority guidelines.
12. 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.
13. Care should be taken when attaching other equipment as this may affect mechanical
stability.
14. Any computer connected to the ventilator must be specified for medical use .
15. There is no special protection provided against ingress of water or liquids.
16. Do not use solvent based cleaning solutions to clean the touch screen or covers.

(Model J) Page 13
Principles of Operation

Page 14 (Model J)
2. Principles of Operation
The SLE5000 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 220.

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2.2 Pneumatic System
The pneumatic system comprises of the tubing and electro-mechanical valves necessary to
provide the gas in conventional and oscillatory 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 pressures generated from the three nozzles are controlled by three
electronically controlled pressure regulators. The negative and one of the positive nozzle
pressures can also be switched on and off rapidly with in-line (high speed) solenoid valves.
The other positive nozzle (the mean jet) is used to generate steady pressures in ventilation
(CPAP or PEEP pressures in conventional modes and mean pressures in HFO modes).
These three nozzles (or jets) are used in various combinations to generate all ventilation
modes.
2.2.3 Conventional ventilation
In non HFO modes 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 rather than switching a steady pressure with
the high speed valves.
This provides a smooth rise in pressure and allows user adjustable rise times rather than
abrupt changes and pressure “ringing” which can result from high speed switching. The fall
of the inspiratory wave is also controlled by the forward jet pressure regulator to bring the
pressure down quickly and smoothly, using the high speed valves to do this would again
result in inadvertent ‘ringing’ which causes difficulties for the monitor subsystem in trying to
detect a patient breath attempt by monitoring the pressure alone. 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.

Page 16 (Model J)
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.
2.2.4 HFO ventilation
In pure HFO mode the mean jet pressure regulator is used purely to set the mean pressure.
The forward and reverse jet pressure regulators are used to generate steady positive and
negative delta P components that will be superimposed on the mean pressure. These
components are switched quickly using the high-speed solenoid valves to generate the HFO
pressures.
For example to ventilate a patient with a mean pressure of 10 mbar and a delta P pressure
of 60 mbar, the mean jet will be set to generate a continuous pressure of 10 mbar, the
forward jet will be set to generate a continuous pressure of 30 mbar and the reverse jet will
be generating a continuous pressure of –30 mbar. The HFO rate is determined by the rate of
switching between the forward and reverse pressures on the high-speed valves. Again,
because the jet pressures sum, the resulting patient pressures will be switching between –
20 mbar and +40 mbar.
Mean HFO pressures up to 35mbar are required but the mean jet can only generate
pressures up to about 20 mbars. To obtain higher mean pressures than 20mbars in HFO it is
necessary to apply a higher pressure on the forward pressure regulator and a lower
pressure on the reverse pressure regulator. Using this method, the desired mean must be
less than half the desired delta p pressure plus 20 mbars.
See “Pneumatic Unit Schematic” on page 222.

(Model J) Page 17
Description of Symbols

Page 18 (Model J)
3. Description of Symbols
Symbol Description
Type BF connection (Situated on front 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)
Indicates the mains power switch
Mains power present, (Situated on front panel)
Indicates a warning in the manual
Observe anti static precautions

(Model J) Page 19
Indicates a note in the manual
Indicates a caution in the manual
Check list item.
Symbol Description

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