SLE 4000 User manual

4000
Brand
SLE
Model
4000
Type
User manual

This manual is also suitable for

SLE5000 / SLE4000
User manual
Version 5.0 software
Page 2
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 29/04/2016
Manual: UM131 Issue 4
SLE Part Nº: UM131/V05/UK
Note: This manual has been written for use with model
G to
N ventilators. It is also
applicable to model A to F ventilators that have had the software upgraded to Version
5.0, but the user must note that there are hardware differences.
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: Sales & Training [email protected]
Service [email protected]
(E-mails should be addressed to the Service Manager)
Web site: www.sle.co.uk
Page 3
How To Use The
SLE5000/SLE4000 Infant Ventilator
The warnings on pages 24 to 27 must be read and understood before
using the SLE5000/SLE4000 ventilator. Failure to do so could lead to
injury or death of the patient.
1 WE RECOMMEND THE VENTILATOR BACK-UP POWER SUPPLY IS
FULLY CHARGED PRIOR TO USE: Page 68.
2 PERFORM THE PRE-USE TEST: Page 64.
3 SETUP THE VENTILATOR IN THE CHOSEN MODE: Page 84.
4 THE VENTILATOR IS READY FOR USE.
For troubleshooting see “Troubleshooting Chart” on page 112.
For more technical data see “Technical information” section on page 121.
For more installation information see “Installation” on page 122.
Page 4
This page is intentionally blank.
Page 5
Contents
1. Introduction ..................................................10
1.1 About This Manual.................................10
1.2 Intended Use .........................................10
1.3 Intended Users ......................................10
2. What’s New in version 5 ..............................11
2.1 TTV
plus
mode..........................................11
2.2 TTV
plus
volume alarm threshold changes11
2.2.1 Ti & Max Ti ............................................11
2.3 Discontinuing TTV
plus
.............................11
2.4 Leak compensation ...............................11
2.5 Cycle fail alarm with flow sensor
connected ..............................................11
2.6 Apnoea alarm active threshold reduction
from 20BPM to 10BPM11
2.7 Pressure and Flow waveform option .....11
2.8 Variable I:E ratio in HFO ventilation ......11
2.9 HFO mean control increased to 45
mbar ......................................................11
2.10 Ability to set the Delta P in preview
mode......................................................11
2.10.1 HFO only ...............................................11
2.10.2 HFO+CMV.............................................11
2.11 Default flow trigger setting of 0.6 l/min ..12
2.12 Minute volume alarm thresholds -
quick access ..........................................12
2.13 Change in the display of measured Vte.12
2.14 Modified operation of Main Power Fail
alarm......................................................12
2.15 Quick setup and functional testing
changes. ................................................12
2.16 FiO
2
control renamed O
2
%....................12
3. Description of the Ventilation Modes ........13
3.1 CPAP (with a flow sensor).....................13
3.1.1 CPAP with Apnoea Backup ...................13
3.1.2 CPAP with TTV
plus
for Backup Breaths..13
3.2 CPAP (without a flow sensor)................13
3.3 CMV.......................................................14
3.3.1 CMV with TTV
plus
....................................14
3.4 PTV........................................................14
3.4.1 PTV with TTV
plus
.....................................14
3.5 PSV .......................................................15
3.5.1 PSV with TTV
plus
....................................15
3.6 SIMV......................................................16
3.6.1 SIMV with PSV ......................................16
3.6.2 SIMV with TTV
plus
...................................16
3.7 HFO (SLE5000 only) .............................17
3.8 HFO+CMV (SLE5000 only) ...................17
3.9 Overview of Conventional Ventilation
Modes18
3.10 Detailed description of TTV
plus
, HFO MAP
Compensation & Automatic Leak
Compensation in PSV modes19
3.10.1 TTV
plus
....................................................19
3.11 Automatic Leak Compensation in PSV .
modes19
3.12 HFO mean compensation......................19
4. Technical Description ..................................20
5. User/Owner Responsibility .........................21
6. Warnings .......................................................24
6.1 Operational Warnings ............................24
6.1.1 General ..................................................24
7. Clinical Warnings .........................................27
7.1 Monitoring ..............................................27
7.2 Clinical considerations ...........................27
8. Ventilator Description ..................................30
9. Description of Symbols and Buttons .........33
10. User Interface .............................................36
10.1 User Interface Sections .........................36
10.2 Description of User Interface Indicators.36
10.3 Description of User Interface Controls...36
10.3.1 Examples of Control Use .......................36
10.4 Description of the Mode Panel in
Ventilation Off Mode ..............................38
10.5 Mode Select Button ...............................38
10.5.1 Oxygen Alarm Test ................................38
10.6 Services Panel.......................................38
10.6.1 Flow .......................................................39
10.6.2 Oxygen ..................................................39
10.6.3 Wave Shaping .......................................39
10.6.4 Alarm Volume ........................................39
10.6.5 Patient Leak Alarm Limit........................39
10.6.6 More Options Panel ...............................39
10.6.7 Language Toggle...................................40
10.6.8 Waveform Display Sync........................40
10.6.9 Set Time and Date.................................40
10.6.10 Version Information Panel .....................41
10.6.11 Monitor Services ....................................41
10.6.12 Controller Services ................................41
10.7 Mode Panel Functions in a Ventilation
Mode......................................................42
10.7.1 Standby Button (All modes) ...................43
10.7.2 Apnoea Setup for CPAP ........................43
10.7.3 Apnoea Setup for PTV & PSV and
SIMV ......................................................44
10.7.4 TTV
plus
for CPAP, PSV, PTV & SIMV.....44
10.7.5 Set Trigger for CPAP, PSV, PTV &
SIMV ......................................................45
10.7.6 Pressure Support in PSV.......................45
10.7.7 Pressure Support in SIMV .....................45
10.7.8 HFO Activity (SLE5000 Only) ................45
10.8 Alarm Panel ...........................................46
10.9 Default Waveform Windows ..................47
10.10 Alarm and Breath Detection Thresholds47
10.11 How to Set an Alarm Threshold.............48
10.12 Ventilation Parameters ..........................50
10.13 Lung Mechanics and Measurement
Panel......................................................51
10.14 The Pause Button ..................................52
10.15 Night Button and Screen Lock ...............52
Page 6
11. Loops, Trends & Waveforms .................... 54
11.1 Waveforms............................................ 54
11.2 Loops .................................................... 55
11.2.1 Capturing, Retrieving & Deleting Loops.55
11.3 Trends................................................... 56
11.3.1 Minute Volume trend............................. 56
11.3.2 Description of Trend Windows .............. 56
12. Ventilator Set-up ........................................ 58
12.1 Preparing the Ventilator for Use............ 58
12.2 Ventilator Power Up and Power Down.. 60
12.2.1 Mains power indicator. .......................... 60
12.2.2 Powering up and down. ........................ 60
12.2.3 Turning ON the ventilator ...................... 60
12.2.4 Turning OFF the ventilator .................... 60
12.3 Back-up Battery Charging ..................... 60
12.4 Battery indicator .................................... 61
12.4.1 Explanation of battery charging. ........... 61
12.5 Suspension of the “Main Power Fail”
alarm. .................................................... 61
12.6 Extended storage .................................. 62
12.6.1 Screw cap fuse holder .......................... 62
12.6.2 Drawer type fuse holder........................ 62
13. Pre-use test ................................................ 64
13.1 Pre-use test checklist ............................ 65
14. Operational Considerations ..................... 68
14.1 General ................................................. 68
14.1.1 Ventilation Off Mode ............................. 68
14.1.2 CPAP Mode without a Flow Sensor and
with the Apnoea alarm set to “OFF”...... 68
14.1.3 SIMV Mode without a Flow Sensor and
with the Apnoea alarm set to “OFF ....... 68
14.1.4 Gas Input Pressures ............................. 68
14.1.5 Mode Memory On Power Up ................ 68
14.1.6 Backup Battery Power .......................... 68
14.1.7 Parameter Memory ............................... 69
14.1.8 BPM or Backup, Measured and Set
Parameters ........................................... 69
14.1.9 Tidal Volume Parameter Resolution ..... 69
14.1.10 Displayed O
2
%...................................... 69
14.1.11 HFO mode, Mean & Delta P
Parameters ........................................... 69
14.1.12 HFO variable I:E ratio ........................... 69
14.1.13 HFO Mean compensation ..................... 69
14.1.14 Breath Detection ................................... 70
14.1.15 Targeted Tidal Volume, Vte (TTV) ........ 70
14.1.16 Max Ti in PSV ....................................... 70
14.1.17 Wave Shaping....................................... 71
14.1.18 Flow sensor removal for suctioning or
re-calibration, pausing ventilation ......... 71
14.1.19 Flow sensor removal for suctioning or
re-calibration but continuing ventilation. 72
14.1.20 BPM Tot. Measurement. ....................... 72
14.2 Alarms................................................... 73
14.2.1 High and Low Alarm Operation ............. 73
14.2.2 Minute Volume Alarm Threshold........... 74
14.2.3 Tidal Volume Alarm Threshold.............. 74
14.2.4 Cycle Fail Alarm Threshold ................... 74
14.2.5 Sub-ambient Pressure Alarm in Non HFO
Modes ................................................... 74
14.2.6 HFO Only Ventilator Set Threshold Alarms
(SLE5000 only) ..................................... 74
14.2.7 Patient Leak Alarm ................................ 75
14.2.8 Reset Contamination Alarm .................. 75
14.3 Patient Circuits, Humidification and Nitric
Oxide Therapy....................................... 76
14.3.1 Autofeed Humidification chambers........ 76
14.3.2 Nitric Oxide Therapy ............................. 76
14.3.3 Nebulization of Medication ................... 77
15. Flow and Pressure Triggering ..................80
15.1 Breath Detection Threshold (Flow
Triggering)............................................. 80
15.2 Breath Trigger Sensitivity (Pressure
Triggering)............................................. 80
15.3 Setting the Pressure Trigger Level in CPAP,
SIMV, PTV and PSV ............................ 81
16. Basic Set-up ...............................................84
16.1 Pre set-up checks ................................. 84
16.2 Setting the O
2
% .................................... 84
16.3 CPAP Set-up......................................... 85
16.3.1 Actions after connection to patient in
CPAP .................................................... 85
16.3.2 Interactive and limiting controls in
CPAP .................................................... 85
16.3.3 TTV
plus
(Volume targeting) of backup
breaths in CPAP.................................... 86
16.3.4 Ventilation without a flow sensor
connected.............................................. 86
16.3.5 Ventilation with the Apnoea alarm turned
“OFF”..................................................... 86
16.4 CMV Set-up........................................... 87
16.4.1 Actions after connection to patient in
CMV ...................................................... 87
16.4.2 Interactive and limiting controls in CMV 87
16.4.3 TTV
plus
(volume targeting) all mechanical
breaths in CMV. .................................... 88
16.4.4 Ventilation without a flow sensor
connected.............................................. 88
16.5 PTV Set-up............................................ 89
16.5.1 Actions after connection to patient in
PTV ....................................................... 89
16.5.2 Interactive and limiting controls in PTV. 90
16.5.3 TTV
plus
(Volume targeting) of all triggered
and mechanical breaths in PTV. ........... 90
16.5.4 Ventilation Without a Flow Sensor
Connected............................................. 90
16.6 PSV Set-up ........................................... 91
16.6.1 Actions After Connection to Patient in
PSV ....................................................... 91
16.6.2 Interactive and limiting controls in PSV. 92
16.6.3 TTV
plus
(Volume targeting) of all triggered
and mechanical breaths in PSV. ........... 92
16.6.4 Ventilation Without a Flow Sensor
Connected............................................. 92
16.7 SIMV Set-up.......................................... 93
Page 7
16.7.1 Actions After Connection to Patient in
SIMV......................................................93
16.7.2 Interactive and limiting controls in
SIMV......................................................94
16.7.3 TTV
plus
(Volume targeting) of all
synchronized and mechanical breaths in
SIMV......................................................94
16.7.4 Ventilation Without a Flow Sensor
Connected. ............................................95
16.8 HFO Only Set-up (SLE5000 only) .........96
16.8.1 Actions After Connection to Patient in
HFO .......................................................96
16.8.2 Interactive and limiting controls in HFO. 97
16.8.3 Ventilation Without a Flow Sensor
Connected. ............................................97
16.9 HFO+CMV Set-up (SLE5000 only) .......98
16.9.1 Actions After Connection to Patient in
HFO+CMV.............................................98
16.9.2 Limiting controls in HFO+CMV ..............98
16.9.3 Ventilation Without a Flow Sensor
Connected. ............................................98
17. N5402-REV2 & N5302 Flow Sensor ..........100
17.1 Calibration of the Flow Sensor ..............100
17.2 Cleaning and Sterilization of the N5402-
REV2 Sensor.........................................101
18. Frequently Asked Questions ....................104
18.1 Ventilator Related Questions.................104
18.2 Mode Related Questions.......................105
18.3 Patient Circuits ......................................106
19. Commonly Seen Alarms ...........................108
19.1 High Pressure........................................108
19.2 Low Pressure.........................................108
19.3 Breath Not Detected ..............................108
19.4 Low Tidal Volume ..................................108
19.5 Unexpected Rise or drop in Mean P.
(SLE5000 only)......................................108
19.6 Unexpected Rise or Drop in Max P.
(SLE5000 only)......................................108
19.7 Unexpected Rise or Drop in Min P.
(SLE5000 only)......................................108
19.8 Continuing Positive Pressure ................108
19.9 Leaking Fresh Gas ................................109
19.10 High Patient Leak ..................................109
19.11 Clean Flow Sensor ................................109
19.12 Faulty Flow Sensor................................109
19.13 Flow Calibration Fail ..............................109
19.14 Calibrate Flow Sensor ...........................109
19.15 Apnoea ..................................................109
20. Troubleshooting Chart ..............................112
20.1 Ventilation Related Problems ................112
20.2 Ventilator Related Problems..................114
21. Installation ..................................................122
21.0.1 Tools required for trolley assembly........122
21.1 Trolley assembly....................................122
21.2 Ventilator mounting................................123
21.3 Back-up battery connection ...................123
21.4 Ventilator labelling .................................123
21.5 Mains cable attachment.........................124
21.6 Water trap attachment ...........................124
21.7 Miscellaneous items ..............................124
22. Secondary Language Selection ................125
22.1 Activation of Language Selection
Program .................................................125
23. Oxygen Calibration Routines ....................126
23.1 One Point O
2
Calibration .......................126
23.2 Two Point O
2
Calibration .......................126
24. Functional Testing & Preventative
Maintenance Schedule ...............................127
24.1 Functional testing...................................127
24.2 Preventative Maintenance .....................127
24.2.1 Preventative Maintenance Model M-1 ...127
24.2.2 Preventative Maintenance Model N.......127
25. RS232 ..........................................................128
25.1 Cautions for RS232 ...............................128
25.2 Location of RS232 Port..........................128
25.3 Overview................................................128
25.3.1 Data and Pinout Description. .................128
25.3.2 Cable .....................................................128
25.3.3 Parameter Descriptions and Format......129
25.3.4 List of Parameters..................................129
25.3.5 Table of Current Alarm Condition
Codes. ...................................................131
25.4 RS232 Connection Settings and Testing
Data Output ...........................................131
26. Alarms .........................................................132
26.1 Alarm Protocols .....................................132
26.2 Alarm Sounds ........................................132
26.2.1 Un-recognized alarm condition ..............132
26.3 Alarm descriptions and actions to be
taken ......................................................133
26.4 Software and System Fail Protocols......144
27. Bacterial Filters ..........................................145
27.1 Bacterial filter, SLE Part Nº:N2029
(Autoclavable)........................................145
27.2 Bacterial filter, SLE Part Nº: N2587/000/001
(Single use)............................................145
28. Patient Circuits ...........................................146
28.1 Warnings for Patient Circuit Use............146
28.2 Generic 10mm Re-usable Patient
Circuit.....................................................147
28.3 Generic 10mm Single Use Patient
Circuit.....................................................148
28.4 Generic Nitric Oxide Delivery Adaptor
Kit...........................................................149
29. Cleaning, Disinfection and Sterilization ..150
29.1 Preparation of a New Ventilator.............150
29.2 Cleaning and Disinfection of an In-service
Ventilator................................................150
29.3 Cleaning, Disinfection & Sterilization
Chart ......................................................150
Page 8
29.4 Cleaning Method................................... 151
29.4.1 Ventilator ............................................... 151
29.4.2 Flow Sensor .......................................... 151
29.4.3 Exhalation block .................................... 151
29.5 Disinfection Method .............................. 151
29.5.1 Ventilator. .............................................. 151
29.5.2 Flow Sensor .......................................... 151
29.5.3 Exhalation block .................................... 151
29.6 Sterilization Method .............................. 151
30. Technical Specification ............................152
30.1 Operating Modes Conventional
Ventilation ............................................. 152
30.1.1 CPAP .................................................... 152
30.1.2 CMV ...................................................... 152
30.1.3 PTV ....................................................... 152
30.1.4 PSV....................................................... 152
30.1.5 SIMV ..................................................... 153
30.1.6 HFO Ventilation..................................... 153
30.1.7 HFO+CMV ............................................ 153
30.1.8 Controls (Via touchscreen display) ....... 154
30.1.9 Controls................................................. 155
30.2 Measurement ........................................ 155
30.2.1 Flow and Volume .................................. 155
30.2.2 Oxygen Concentration .......................... 155
30.2.3 Pressure................................................ 156
30.3 Exhalation Block Port Jet Sizes ............ 156
30.4 Alarms................................................... 156
30.4.1 User settable Alarms............................. 156
30.4.2 Obligatory Alarms (non adjustable by
user)...................................................... 156
30.5 Patient circuits....................................... 157
30.6 Outputs ................................................. 157
30.7 Gas supplies ......................................... 158
30.7.1 Oxygen supply ...................................... 158
30.7.2 Air supply .............................................. 158
30.7.3 Input pressures and ventilator
performance.......................................... 158
30.8 Power, Dimensions, Classification etc. . 158
30.8.1 Operating Environment: ........................ 158
30.8.2 Connectors............................................ 158
30.9 Classification ......................................... 158
30.10 Environmental Storage Conditions ....... 158
31. Functional Testing ...................................160
31.1 Functional testing .................................. 160
31.1.1 Complete Power Fail Alarm Test. ......... 160
31.1.2 Back-up alarm speaker test .................. 161
31.1.3 Setting O
2
% .......................................... 161
31.1.4 Functional Testing without a Flow
Sensor................................................... 161
31.1.5 Calibration of the Flow sensor .............. 161
31.1.6 Oxygen Alarm Test ............................... 162
31.1.7 Function and Alarm Testing .................. 163
31.1.8 High Pressure Alarm ............................. 165
31.1.9 Low Pressure Alarm.............................. 165
31.1.10 Breath Not Detected Alarm ................... 166
31.1.11 Leak / Block Alarm ................................ 166
31.1.12 Mains Failure Alarm .............................. 167
31.1.13 Gas Supply Alarms ............................... 167
31.1.14 Flow Sensor Disconnect Alarm ............. 168
31.1.15 Cycle Fail Alarm .................................... 168
31.1.16 Functional Test of HFO Mode ............... 173
31.1.17 Functional Test of HFO+CMV Mode..... 175
31.1.18 Pressure Change Alarm ........................ 176
32. EMC compliance ........................................178
32.1 Electromagnetic immunity ..................... 179
32.2 Recommended separation distances
between portable and mobile RF
communications equipment and the
SLE4000 & SLE5000181
33. Pneumatic Unit Schematic SLE4000 Model
H, K & N .......................................................182
34. Pneumatic Unit Schematic SLE5000 Model
G, G-R, J, L & M ..........................................183
35. Ventilator Labelling ...................................184
35.1 SLE4000 model N ................................. 184
35.2 SLE5000 Model M-1 ............................. 185
36. Consumables and Accessories ...............188
37. Glossary of Abbreviations Used in this
Manual .........................................................194
38. Index ...........................................................195
Page 9
Introduction
Page 10
1. Introduction
1.1 About This Manual
This user manual details the operation of the
SLE4000 and SLE5000 infant ventilators. The
difference between the SLE4000 and SLE5000
ventilator is that the SLE5000 has two extra modes
of operation, these being HFO and HFO+CMV.
The user manual will from this point onwards refer
to the SLE4000 and SLE5000 as “the ventilator”.
Where the user manual details an operation or
mode, specifically HFO or HFO+CMV then a
statement will appear stating, “SLE5000 only”.
The following are the external differences between
the SLE4000 and SLE5000 ventilators.
A. Overlays (SLE5000 overlays are blue, SLE4000
overlays are green).
B. Installed software. (Start up screens and Mode
select panels.)
1.2 Intended Use
The ventilator is designed for use on patients up to
20kg, in conventional ventilation. In high frequency
oscillation ventilation up to 20kg, dependant on lung
condition (SLE5000 only). The ventilator is designed
for “Continuous Operation”.
1.3 Intended Users
The ventilator is to be used by appropriately trained
and authorized personnel only. In this manual they
will be referred to as the “User”.
Note: HFO and HFO+CMV modes are not
available on the SLE4000 infant ventilator.
Note: All the graphics within this manual have
been produced with the N6647 test lung and
are not representative of actual clinical data.
Page 11
2. What’s New in version 5
2.1 TTV
plus
mode
The TTV
plus
algorithm mode has been modified to
provide a more stable volume delivery.
2.2 TTV
plus
volume alarm threshold
changes
Instead of auto tracking Vte alarms setting, above
and below the set Vte by ±3ml, the auto tracking low
tidal volume alarm will track to 10% or 1 ml below
the set Vte (whichever is lower) and the high tidal
volume alarm will track to 30% or 3ml above the set
Vte (whichever is higher).
The high and low minute volume alarms will now be
auto tracking as follows. The low minute volume
alarm shall be set to 50% below the VTE x BPM or
VTE x Backup breath rate, depending on the mode.
The high minute volume alarm shall be set to 200%
above the VTE x BPM or VTE x Backup breath rate,
depending on the mode.
When TTV
plus
is exited, the alarms shall reset to
their defaults.
See 14.2.2 & 14.2.3 on page 74.
2.2.1 Ti & Max Ti
When turning on the TTV function the Ti control no
longer changes to Max Ti.
2.3 Discontinuing TTV
plus
When switching from a mode with TTV
plus
set to ON
to a mode that does not support TTV
plus
(HFO &
HFO+CMV), or when the user turns OFF TTV
plus
the
ventilator sets the PIP level to the last used PIP
level from the MAX PIP control (This is not the set
MAX PIP) with a minimum of 5 mbar above the set
PEEP. The user should ensure the PIP is set
correctly and adjust if required.
The ventilator will display the following message
after discontinuing TTV
plus:
“TTV has been turned
OFF. Ensure PIP is set appropriately”.
2.4 Leak compensation
The leak compensation is automatically applied and
the leak compensation control is no longer present.
The algorithm will now compensate for leaks up to
50%.
2.5 Cycle fail alarm with flow sensor
connected
The pressure waveform will display the cycle fail
alarm threshold in all conventional modes. The
cycle fail alarm threshold will not be displayed when
the TTV
plus
function has been turned on, but the
cycle fail alarm is still active (See “Cycle Fail Alarm
Threshold” on page 74 for more information).
2.6 Apnoea alarm active threshold
reduction from 20BPM to 10BPM
The Apnoea Setup button will become active (in
SIMV, PTV and PSV modes) when the breath rate is
set below 10BPM, this was 20BPM in version 4.3
software.
2.7 Pressure and Flow waveform option
A new option in the Graph panel (Flow Real Time
button) has been added. Selection of the option will
display Pressure and Flow waveform windows only.
2.8 Variable I:E ratio in HFO ventilation
The user now has the ability to select the following
I:E ratios. 1:1, 1:2 & 1:3.
2.9 HFO mean control increased to 45
mbar
The upper range of the settable HFO mean has
been increased from 35 mbar to 45 mbar.
2.10 Ability to set the Delta P in preview
mode
2.10.1 HFO only
The user now has the ability to change the Delta P
up to a maximum of twice the set mean in preview
mode. In preview mode the mean is limited to 18
mbar which means that the maximum Delta P that
can be set is 36 mbar. The above statement is only
applicable for the preview mode.
If the mean is adjusted down then the Delta P will be
automatically reduced as appropriate. The Delta P
starting default value is 4 mbar.
2.10.2 HFO+CMV
The same shall apply when previewing HFO+CMV
mode. In HFO+CMV mode there is no mean control,
the Delta P shall be adjustable up to twice the set
PEEP. In preview mode the full PEEP setting of 20
mbar can be set which means that the maximum
Delta P that can be set is 40 mbar.
Note: For PSV the inspiratory time control is
always marked Max Ti irrespective of TTV
being ON or OFF.
Page 12
2.11 Default flow trigger setting of 0.6 l/
min
The default setting for the flow trigger in the flow
waveform window has been reduced from 2 l/min to
0.6 l/min.
2.12 Minute volume alarm thresholds -
quick access
The minute volume alarm threshold can be
accessed by pressing and holding the adjust button
in the alarm panel for greater than 3 seconds. This
will bring the user directly to the minute volume
waveform window. The minute volume alarm
thresholds are also quicker to adjust now.
2.13 Change in the display of measured
Vte
The Vte now displayed will either be a mechanical
(large) or spontaneous (small) breaths. The Vte
value in the lung mechanics panel will switch
between the large and small breath measurements,
according to the classification of the preceding
breath.
The table below gives a description of the types of
breath.
For further information see section ’14.1.16.4
Fluctuation of measured Vte’ on page 70.
2.14 Modified operation of Main Power
Fail alarm
The user can now silence the main power fail alarm
by pressing the Reset button in the alarm panel. A
message will be displayed in the top left hand
corner of the screen showing that the ventilator is
running on battery. Re-connection of mains power
will cancel the message.
2.15 Quick setup and functional testing
changes.
The quick setup process has been reviewed and
made shorter. Functional testing is now only
required at 3 monthly intervals or when the user
requires to check the performance of the ventilator.
2.16 FiO
2
control renamed O
2
%
FiO
2
control has been renamed O
2
%
Mode Vte (ml) large Vte (ml) small
CPAP Apnoea backup
breaths and manual
breaths only.
Unassisted
breaths
CMV Mandatory breaths
and manual breaths.
Unassisted
breaths
PTV Mandatory backup
breaths, triggered
breaths and manual
breaths
Unassisted
breaths.
PSV Mandatory backup
breaths, triggered
breaths and manual
breaths.
Unassisted
breaths.
SIMV SIMV breaths
(triggered and
untriggered) and
manual breaths
Unassisted
breaths and
PSV breaths.
HFO Expired volume
averaged over 3
breaths
N/A
Page 13
3. Description of the Ventilation
Modes
The ventilator has the ability to be used as either a
pressure controlled, volume targeted ventilator, as a
pressure limited, time cycled ventilator, and the
SLE5000 as a high frequency oscillation ventilator.
3.1 CPAP (with a flow sensor)
Continuous Positive Airway Pressure
The ventilator generates a continuous positive
airway pressure at a level set by the User. The
apnoea alarm will sound if the patient has not made
any breath attempts within the set apnoea period.
User sets the following:-
• CPAP
• Apnoea alarm time
• Backup breaths ON or OFF
• Manual breath parameters (Ti and PIP)
• O
2
%
• Flow breath detection threshold (Trigger
Sensitivity) – The patient effort required for the
ventilator to recognise the breath
• High and low pressure alarm thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume, high and low alarm thresholds
3.1.1 CPAP with Apnoea Backup
This is as for basic CPAP mode but if the patient
does not make a breath attempt within the Apnoea
time then a pressure limited, time cycled backup
breath is provided.
The user turns ON the backup breaths function.
3.1.2 CPAP with TTV
plus
(Targeted Tidal Volume)
for Backup Breaths.
This is as for basic CPAP with Apnoea Support,
where the inspiratory pressure shall be controlled by
the ventilator to achieve the user set Vte.
The User sets the following:-
• Enables Targeted Tidal Volume (TTV) and
selects volume to be delivered (Vte)
• Max PIP
3.2 CPAP (without a flow sensor)
The ventilator generates a continuous positive
airway pressure at a level set by the User.
User sets the following:-
• CPAP
• Apnoea Alarm ON/OFF
• Manual Breath parameters (Ti and PIP)
• O
2
%
• High and low pressure alarm thresholds
See “CPAP Mode without a Flow Sensor and with
the Apnoea alarm set to “OFF”” on page 68 of the
“Operational Considerations” chapter for information
on disabling the Apnoea alarm and action to be
taken.
Warning: If apnoea alarm is disabled when
the ventilator is used in CPAP mode without a
flow sensor, the ability for the ventilator to
deliver backup breaths is also disabled.
Backup breaths are disabled as they require
the Apnoea alarm to be triggered. Manual
breaths can still be delivered.
When the Apnoea is turned “OFF”, an
alternative method of detecting an apnoeic
episode must be used. The ventilator will not
alarm or provide mechanical backup breaths.
Note: The Apnoea alarm is automatically
enabled when the flow sensor is connected
and calibrated or if the user leaves CPAP
mode and enters any other ventilatory mode.
Page 14
3.3 CMV
Continuous Mandatory Ventilation
In this mode the inspiratory cycle is initiated by the
ventilator at a set BPM rate. The breaths are time
cycled.
The User sets the following:-
• BPM
• Positive End Expired Pressure (PEEP)
• Peak Inspiratory Pressure (PIP)
• Inspiratory Time (Ti)
• O
2
%
• High and low pressure alarm thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume, high and low alarm thresholds
3.3.1 CMV with TTV
plus
(Targeted Tidal Volume)
This is as for basic CMV where the inspiratory
pressure shall be controlled by the ventilator to
achieve the user set Vte.
The User sets the following:-
• Enables Targeted Tidal Volume (TTV) and
selects volume to be delivered (Vte)
• Max PIP
3.4 PTV
Patient Triggered Ventilation
In this mode all the patient's breath attempts are
pressure supported. Mechanical breaths are
delivered at the set parameters (Ti, PEEP and PIP)
if no patient effort is recognised.
The User sets the following:-
• Positive End Expired Pressure (PEEP)
• Peak Inspiratory Pressure (PIP)
• Inspiratory Time (Ti)
• Backup breath rate (Backup)
• Apnoea alarm time (Only if backup breath rate is
9 breaths per minute or lower)*
• O
2
%
• Flow breath detection threshold (Trigger
Sensitivity) – The patient effort required for the
ventilator to recognise the breath
• High and low pressure alarm thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume, high and low alarm thresholds
3.4.1 PTV with TTV
plus
(Targeted Tidal Volume)
This is as for basic PTV where the inspiratory
pressure shall be controlled by the ventilator to
achieve the user set Vte (for assisted breaths).
The User sets the following:-
• Enables Targeted Tidal Volume (TTV) and
selects volume to be delivered (Vte)
• Max PIP
*Note: PTV will continue to function as stated,
but with breath rates of 10 and above the
Apnoea alarms are de-activated. Backup rates
of 10 BPM and above are deemed sufficient to
support the patient.
Page 15
3.5 PSV
Pressure Supported Ventilation
This is a pressure limited mode of ventilation in
which each breath is patient triggered and
supported. The breath is patient triggered, pressure
supported and patient terminated. The infant
therefore has control of the whole cycle, i.e. the
inspiratory time and frequency. This form of
ventilation is dependant on the use of a flow sensor
placed between the ET tube connector and the
patient circuit. Changes in flow or volume signal
detects spontaneous breathing.
The termination sensitivity is also user adjustable
from 0% - 50%.
Example: 5% termination sensitivity means that the
pressure support will terminate when the inspiratory
flow drops to 5% of the peak value. The level of
pressure support can be manually adjusted by use
of the PIP parameter control.
PSV can be used in the weaning process. Weaning
is achieved by reducing the support level as the
infant is able to make more effort.
In this mode all the patient's breath attempts are
pressure supported, but mechanical breaths are
delivered at the set parameters (Ti, PEEP and PIP)
when a patient effort is recognised.
The User sets the following:-
• Positive End Expired Pressure (PEEP)
• Peak Inspiratory Pressure (PIP)
• Maximum inspiratory Time (Max Ti)
• Backup breath rate (Backup)
• The flow termination sensitivity
• Apnoea alarm time (Only if backup breath rate is
9 breaths per minute or lower)*
• O
2
%
• Flow breath detection threshold (Trigger
Sensitivity) – The patient effort required for the
ventilator to recognise the breath
• High and low pressure alarm thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume, high and low alarm thresholds
3.5.1 PSV with TTV
plus
(Targeted Tidal Volume)
This is as for basic PSV with Apnoea Support,
where the inspiratory pressure shall be controlled by
the ventilator to achieve the user set Vte (for
assisted breaths).
The User sets the following:-
• Enables Targeted Tidal Volume (TTV) and
selects volume to be delivered (Vte)
• Max PIP
• Max Ti
Note: If the user sets the termination
sensitivity to OFF the PSV mode behaves as
PTV.
*Note: PSV will continue to function as stated,
but with breath rates of 10 and above, Apnoea
alarms are de-activated. Backup rates of 10
BPM and above are deemed sufficient to
support the patient.
Page 16
3.6 SIMV
Synchronised Intermittent Mandatory
Ventilation
The frequency of mandatory breaths is determined
by the BPM control. When a mandatory breath is
due an assist window opens and waits for a
patient's inspiratory effort. When this occurs the
ventilator delivers a synchronised breath (SIMV
breaths). Once the breath has been delivered the
assist window closes until the next set breath is due.
If the ventilator does not see a patient's attempt to
breathe before the end of the defined time window
then a mandatory breath is delivered. The
mandatory breath point is the Time Window minus
the Inspiratory Time.
User sets the following:-
• BPM
• Apnoea alarm time (Only if backup breath rate is
9 breaths per minute or lower)*
• Positive End Expired Pressure (PEEP)
• Peak Inspiratory Pressure (PIP)
• Inspiratory Time (Ti)
• O
2
%
• Flow breath detection threshold (Trigger
Sensitivity) – The patient effort required for the
ventilator to recognise the breath.
• High and low pressure alarm thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume, high and low alarm threshold
3.6.1 SIMV with PSV
SIMV with PSV allows the user to select the
termination sensitivity and pressure support level on
non SIMV breaths. Once a mechanical breath is
delivered to the patient, the flow to the infant rapidly
peaks and then decelerates to the termination
threshold, inspiration ends and expiration can begin.
The following parameters must be selected: PEEP,
PIP, Ti, Breath detection level, Termination
sensitivity level, Backup BPM, Apnoea delay time,
O
2
%.
SIMV with PSV produces time cycled, pressure
limited breaths that are delivered at a set BPM rate.
Any additional patient breath attempts are pressure
supported (Flow cycled, pressure limited).
User sets the following:-
• The flow termination sensitivity
• Percentage pressure support, expressed as %
∆P (PIP minus PEEP)
3.6.2 SIMV with TTV
plus
(Targeted Tidal Volume)
This is as for basic SIMV (with or without Pressure
Support) with Apnoea Support, where the
inspiratory pressure shall be controlled by the
ventilator to achieve the user set Vte (for assisted
breaths).
The User sets the following:-
• Enables Targeted Tidal Volume (Vte (TTV)) and
selects volume to be delivered
• Max PIP
*Note: SIMV will continue to function as
stated, but with breath rate of 10 and above,
the Apnoea alarms are de-activated. Backup
rate of 10 BPM and above are deemed
sufficient to support the patient.
Assist windows
Time windows
60
BPM
Time window =
Inspiratory time
Mandatory breath point
Note: The ventilator does not apply
termination sensitivity to SIMV breaths. All
patient triggered, pressure supported breaths
are flow terminated unless the user sets the
stop support percentage value to OFF.
Supported
SIMV breath
SIMV breath
breath
Un-supported
patient breath
below trigger
threshold
triggered
Page 17
3.7 HFO (SLE5000 only)
High Frequency Oscillation
In this mode, the ventilator shall deliver continuous
high frequency oscillation. There is no patient
interaction.
• The User sets the following:-
• HFO rate
• HFO I:E ratio
• Mean pressure
• Pressure amplitude (Delta P)
• O
2
%
• High and low alarm pressure thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume high and low alarm thresholds
3.8 HFO+CMV (SLE5000 only)
A combination of oscillations during the expiratory
or inspiratory & expiratory phase of a time cycled,
pressure limited breath in CMV mode.
The User sets the following:-
• BPM
• Inspiratory Time (Ti)
• Peak Inspiratory Pressure (PIP)
• Positive End Expired Pressure (PEEP)
• HFO rate
• HFO activity (oscillations in inspiratory and
expiratory phases or expiratory phase only)
• Pressure amplitude (Delta P)
• O
2
%
• High and low alarm pressure thresholds
• Tidal volume, high and low alarm thresholds
• Minute volume high and low alarm thresholds
Page 18
3.9 Overview of Conventional
Ventilation Modes
The following table is a brief description of the
trigger, limit and cycle types for each conventional
ventilation mode.
Mode Trigger Limit Cycle
CPAP
CPAP with apnoea
backup
Time trigger Pressure limit Time cycled
CPAP with TTV
plus
Time trigger Volume limit Time cycled
CMV Time trigger Pressure limit Time cycled
CMV with TTV
plus
Time trigger Volume limit Time cycled
PTV Flow or pressure or time
trigger
Pressure limit Time cycled
PTV with TTV
plus
Flow or pressure or time
trigger
Volume limit Time cycled
PSV Flow or time trigger Pressure limit Flow cycled
PSV with TTV
plus
Flow or time trigger Volume limit Flow cycled
SIMV Flow or pressure or time
trigger
Pressure limit Time cycled
SIMV with PSV Flow or pressure or time
trigger
Pressure limit Time & flow cycled
SIMV with TTV
plus
Flow or pressure or time
trigger
Volume limit Time cycled
Page 19
3.10 Detailed description of TTV
plus
, HFO
MAP Compensation & Automatic
Leak Compensation in PSV modes
3.10.1 TTV
plus
TTV
plus
is based upon providing a stable expired
volume at the lowest possible pressure at the set Ti.
3.10.1.1 Detailed Description
When in TTV
plus
mode, the PIP is automatically
controlled to try and maintain the set expiratory
volume. As a safety measure, the pressure cannot
exceed the set Max PIP.
Spontaneous breath volumes are ignored for the
purposes of control.
If SIMV+PSV is used with TTV
plus
then the ventilator
can deliver machine breaths at two different PIP
levels and therefore deliver two different volumes.
No attempt is made to deliver the TTV
plus
volume for
the PSV breaths, only the mandatory breaths are
volume controlled. However the PSV breath
pressure level will change because it is defined as a
percentage of the mandatory breath ∆P (PIP minus
PEEP), which is volume adjusted.
3.11 Automatic Leak Compensation in
PSV modes
If a large leak is present in the respiratory circuit, it
may prevent the flow from being terminated in PSV
mode. If the leak flow is above the selected
termination sensitivity level the flow would not
terminate as the flow would never reach the
termination level.
An algorithm has been added that will compensate
for the leak and enables the termination levels
below leak flow to be terminated at the leak flow
level.
If the termination level is above the leak flow, the
flow is terminated at the selected termination level.
An algorithm would compensate for leak flows up to
5 l/min or 50% of the peak flow whichever happens
first. It is also only active if the leak volume is
between 10% to 50%.
3.12 HFO mean compensation
The ventilator includes a compensation algorithm
that closely maintains the set mean airway pressure
when the Delta P is increased/decreased.
In certain situations the mean airway pressure may
still increase in response to changes in Delta P as
the algorithm only has limited control over the
inadvertent mean airway pressure (10 mbar). The
feature may be disabled by the user if required.
Warning: The user should set the MAX PIP
close to measured PIP (4 to 5 mbar above
measured PIP or as per clinical
recommendation). If the flow sensor is
removed from the circuit (for suctioning or re-
calibration) and the patient circuit is
reconnected, the ventilator senses that the
Vte has dropped below the set target level. It
will then increase the pressure up to the set
MAX PIP to try and achieve the set Vte.
Note: HFO mean compensation cannot be
disabled whilst in a ventilatory mode.
Page 20
4. Technical Description
The ventilator is a computer controlled ventilator.
The computer is broken down into three electronic
subsystems that are housed in the upper
(electronic) section of the ventilator.
The three sub systems are user interface, monitor
and controller.
The interface subsystem controls the user interface,
the display and the touchscreen. The controller
subsystem regulates the pneumatic systems of the
ventilator. The monitor subsystem collects and
processes flow data and generates the alarms.
Each subsystem communicates with the other two
in a peer to peer protocol, i.e. no subsystem is in
complete control.
The ventilator is fitted with an auto-ranging power
supply that is capable of working with mains
supplies of 100V to 240V 50-60 Hertz. (Fuse ratings
T2.0AH 250V (5x20mm)).
The ventilator carries an onboard backup power
supply, which consists of sealed lead/acid batteries,
that can power the ventilator in the event of a mains
power fail. The batteries are charged from the
ventilators power supply. Both the battery supply
and mains power supply are monitored by the
ventilators other subsystems. In normal modes of
ventilation and with a fully charged battery, in a
mains power fail situation the ventilator will continue
to operate for 45 minutes to 60 minutes depending
on ventilation mode.
The pneumatic system consists of the following:
An electronic oxygen blender supplying blended gas
to a mixing chamber. The blended gas is then
controlled via solenoid valves to supply the
conventional ventilation system and the oscillatory
system.
For conventional ventilation (SLE4000 & SLE5000)
the gas is controlled by two pressure regulators that
produce positive and negative gas flows via the
forward and reverse jets.
For oscillatory ventilation (SLE5000 only) the gas
flow is controlled by four in-line high speed solenoid
valves that produce the oscillatory gas flow via the
forward and reverse jets.
See the pneumatic schematics on page 182.
The exhalation block mounts onto two jet ports one
forward/reverse and one mean pressure.
Pressure is monitored via the proximal airway port
through a pair of pressure transducers with data
being sent to the monitor subsystem.
Flow is monitored by a dual hot wire anemometer
mounted at the ET manifold with the flow data being
sent to the monitor subsystem.
Note: The SLE5000 and SLE4000 ventilators
have different pneumatic units.
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SLE 4000 User manual

4000
Brand
SLE
Model
4000
Type
User manual
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