User Manual
199 Pages
Preview
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SLE5000 / SLE4000 User manual Version 5.0 software
Software/Manual application Information:
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. Contact Information: 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 Service
[email protected] [email protected] (E-mails should be addressed to the Service Manager)
Web site:
www.sle.co.uk
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: SLE Part Nº:
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UM131 Issue 4 UM131/V05/UK
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.
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Contents 1. Introduction ...10
4. Technical Description ...20
1.1 1.2 1.3
5. User/Owner Responsibility ...21
About This Manual...10 Intended Use ...10 Intended Users ...10
2. What’s New in version 5 ...11 2.1 2.2 2.2.1 2.3 2.4 2.5
TTVplus mode ...11 TTVplus volume alarm threshold changes11 Ti & Max Ti ...11 Discontinuing TTVplus ...11 Leak compensation ...11 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 FiO2 control renamed O2%...12 3. Description of the Ventilation Modes ...13 3.1 3.1.1 3.1.2 3.2 3.3 3.3.1 3.4 3.4.1 3.5 3.5.1 3.6 3.6.1 3.6.2 3.7 3.8 3.9
CPAP (with a flow sensor)...13 CPAP with Apnoea Backup ...13 CPAP with TTVplus for Backup Breaths. .13 CPAP (without a flow sensor)...13 CMV...14 CMV with TTVplus...14 PTV...14 PTV with TTVplus...14 PSV ...15 PSV with TTVplus ...15 SIMV...16 SIMV with PSV ...16 SIMV with TTVplus ...16 HFO (SLE5000 only) ...17 HFO+CMV (SLE5000 only) ...17 Overview of Conventional Ventilation Modes18 3.10 Detailed description of TTVplus , HFO MAP Compensation & Automatic Leak Compensation in PSV modes19 3.10.1 TTVplus ...19 3.11 Automatic Leak Compensation in PSV . modes19 3.12 HFO mean compensation...19
6. Warnings ...24 6.1 6.1.1
Operational Warnings ...24 General ...24
7. Clinical Warnings ...27 7.1 7.2
Monitoring ...27 Clinical considerations ...27
8. Ventilator Description ...30 9. Description of Symbols and Buttons ...33 10. User Interface ...36 10.1 10.2 10.3 10.3.1 10.4
User Interface Sections ...36 Description of User Interface Indicators.36 Description of User Interface Controls...36 Examples of Control Use ...36 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 TTVplus 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
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11. Loops, Trends & Waveforms ... 54 11.1 11.2 11.2.1 11.3 11.3.1 11.3.2
Waveforms ... 54 Loops ... 55 Capturing, Retrieving & Deleting Loops.55 Trends ... 56 Minute Volume trend ... 56 Description of Trend Windows ... 56
12. Ventilator Set-up ... 58 12.1 12.2 12.2.1 12.2.2 12.2.3 12.2.4 12.3 12.4 12.4.1 12.5
Preparing the Ventilator for Use... 58 Ventilator Power Up and Power Down.. 60 Mains power indicator. ... 60 Powering up and down. ... 60 Turning ON the ventilator ... 60 Turning OFF the ventilator ... 60 Back-up Battery Charging ... 60 Battery indicator ... 61 Explanation of battery charging. ... 61 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 O2%... 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
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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 15.2 15.3
Breath Detection Threshold (Flow Triggering) ... 80 Breath Trigger Sensitivity (Pressure Triggering) ... 80 Setting the Pressure Trigger Level in CPAP, SIMV, PTV and PSV ... 81
16. Basic Set-up ... 84 16.1 16.2 16.3 16.3.1 16.3.2 16.3.3 16.3.4 16.3.5 16.4 16.4.1 16.4.2 16.4.3 16.4.4 16.5 16.5.1 16.5.2 16.5.3 16.5.4 16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.7
Pre set-up checks ... 84 Setting the O2% ... 84 CPAP Set-up ... 85 Actions after connection to patient in CPAP ... 85 Interactive and limiting controls in CPAP ... 85 TTVplus (Volume targeting) of backup breaths in CPAP... 86 Ventilation without a flow sensor connected... 86 Ventilation with the Apnoea alarm turned “OFF”... 86 CMV Set-up... 87 Actions after connection to patient in CMV ... 87 Interactive and limiting controls in CMV 87 TTVplus (volume targeting) all mechanical breaths in CMV. ... 88 Ventilation without a flow sensor connected... 88 PTV Set-up... 89 Actions after connection to patient in PTV ... 89 Interactive and limiting controls in PTV. 90 TTVplus (Volume targeting) of all triggered and mechanical breaths in PTV. ... 90 Ventilation Without a Flow Sensor Connected. ... 90 PSV Set-up ... 91 Actions After Connection to Patient in PSV ... 91 Interactive and limiting controls in PSV. 92 TTVplus (Volume targeting) of all triggered and mechanical breaths in PSV. ... 92 Ventilation Without a Flow Sensor Connected. ... 92 SIMV Set-up ... 93
16.7.1 Actions After Connection to Patient in SIMV...93 16.7.2 Interactive and limiting controls in SIMV...94 16.7.3 TTVplus (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 17.2
Calibration of the Flow Sensor ...100 Cleaning and Sterilization of the N5402REV2 Sensor...101
18. Frequently Asked Questions ...104 18.1 18.2 18.3
Ventilator Related Questions...104 Mode Related Questions ...105 Patient Circuits ...106
21.4 21.5 21.6 21.7
Ventilator labelling ...123 Mains cable attachment...124 Water trap attachment ...124 Miscellaneous items ...124
22. Secondary Language Selection ...125 22.1
Activation of Language Selection Program ...125
23. Oxygen Calibration Routines ...126 23.1 23.2
One Point O2 Calibration ...126 Two Point O2 Calibration ...126
24. Functional Testing & Preventative Maintenance Schedule ...127 24.1 24.2 24.2.1 24.2.2
Functional testing...127 Preventative Maintenance ...127 Preventative Maintenance Model M-1 ...127 Preventative Maintenance Model N...127
25. RS232 ...128 25.1 25.2 25.3 25.3.1 25.3.2 25.3.3 25.3.4 25.3.5 25.4
Cautions for RS232 ...128 Location of RS232 Port...128 Overview...128 Data and Pinout Description. ...128 Cable ...128 Parameter Descriptions and Format...129 List of Parameters...129 Table of Current Alarm Condition Codes. ...131 RS232 Connection Settings and Testing Data Output ...131
19. Commonly Seen Alarms ...108
26. Alarms ...132
19.1 19.2 19.3 19.4 19.5
26.1 26.2 26.2.1 26.3
19.6 19.7 19.8 19.9 19.10 19.11 19.12 19.13 19.14 19.15
High Pressure...108 Low Pressure...108 Breath Not Detected ...108 Low Tidal Volume ...108 Unexpected Rise or drop in Mean P. (SLE5000 only)...108 Unexpected Rise or Drop in Max P. (SLE5000 only)...108 Unexpected Rise or Drop in Min P. (SLE5000 only)...108 Continuing Positive Pressure ...108 Leaking Fresh Gas ...109 High Patient Leak ...109 Clean Flow Sensor ...109 Faulty Flow Sensor...109 Flow Calibration Fail ...109 Calibrate Flow Sensor ...109 Apnoea ...109
26.4
Alarm Protocols ...132 Alarm Sounds ...132 Un-recognized alarm condition ...132 Alarm descriptions and actions to be taken ...133 Software and System Fail Protocols...144
27. Bacterial Filters ...145 27.1 27.2
Bacterial filter, SLE Part Nº:N2029 (Autoclavable)...145 Bacterial filter, SLE Part Nº: N2587/000/001 (Single use)...145
28. Patient Circuits ...146 28.1 28.2 28.3
Warnings for Patient Circuit Use...146 Generic 10mm Re-usable Patient Circuit...147 Generic 10mm Single Use Patient Circuit...148 Generic Nitric Oxide Delivery Adaptor Kit...149
20. Troubleshooting Chart ...112
28.4
20.1 20.2
29. Cleaning, Disinfection and Sterilization ..150
Ventilation Related Problems ...112 Ventilator Related Problems...114
21. Installation ...122 21.0.1 21.1 21.2 21.3
Tools required for trolley assembly...122 Trolley assembly...122 Ventilator mounting...123 Back-up battery connection ...123
29.1 29.2 29.3
Preparation of a New Ventilator...150 Cleaning and Disinfection of an In-service Ventilator...150 Cleaning, Disinfection & Sterilization Chart ...150
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29.4 29.4.1 29.4.2 29.4.3 29.5 29.5.1 29.5.2 29.5.3 29.6
Cleaning Method ... 151 Ventilator ... 151 Flow Sensor ... 151 Exhalation block ... 151 Disinfection Method ... 151 Ventilator. ... 151 Flow Sensor ... 151 Exhalation block ... 151 Sterilization Method ... 151
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 32.2
30. Technical Specification ... 152 30.1 30.1.1 30.1.2 30.1.3 30.1.4 30.1.5 30.1.6 30.1.7 30.1.8 30.1.9 30.2 30.2.1 30.2.2 30.2.3 30.3 30.4 30.4.1 30.4.2 30.5 30.6 30.7 30.7.1 30.7.2 30.7.3 30.8 30.8.1 30.8.2 30.9 30.10
Operating Modes Conventional Ventilation ... 152 CPAP ... 152 CMV ... 152 PTV ... 152 PSV ... 152 SIMV ... 153 HFO Ventilation... 153 HFO+CMV ... 153 Controls (Via touchscreen display) ... 154 Controls... 155 Measurement ... 155 Flow and Volume ... 155 Oxygen Concentration ... 155 Pressure... 156 Exhalation Block Port Jet Sizes ... 156 Alarms ... 156 User settable Alarms... 156 Obligatory Alarms (non adjustable by user) ... 156 Patient circuits... 157 Outputs ... 157 Gas supplies ... 158 Oxygen supply ... 158 Air supply ... 158 Input pressures and ventilator performance ... 158 Power, Dimensions, Classification etc. . 158 Operating Environment: ... 158 Connectors... 158 Classification ... 158 Environmental Storage Conditions ... 158
31. Functional Testing ... 160 31.1 31.1.1 31.1.2 31.1.3 31.1.4
Functional testing ... 160 Complete Power Fail Alarm Test. ... 160 Back-up alarm speaker test ... 161 Setting O2% ... 161 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
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Electromagnetic immunity ... 179 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 35.2
SLE4000 model N ... 184 SLE5000 Model M-1 ... 185
36. Consumables and Accessories ... 188 37. Glossary of Abbreviations Used in this Manual ... 194 38. Index ... 195
Introduction
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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.)
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.
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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”.
2. What’s New in version 5 2.1 TTVplus mode The TTVplus algorithm mode has been modified to provide a more stable volume delivery.
2.2 TTVplus 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.
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 TTVplus 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
When TTV is exited, the alarms shall reset to their defaults.
The user now has the ability to select the following I:E ratios. 1:1, 1:2 & 1:3.
See 14.2.2 & 14.2.3 on page 74.
2.9 HFO mean control increased to 45 mbar
plus
2.2.1 Ti & Max Ti When turning on the TTV function the Ti control no longer changes to Max Ti. Note: For PSV the inspiratory time control is always marked Max Ti irrespective of TTV being ON or OFF.
2.3 Discontinuing TTVplus When switching from a mode with TTVplus set to ON to a mode that does not support TTVplus (HFO & HFO+CMV), or when the user turns OFF TTVplus 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 TTVplus: “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%.
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.
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2.11 Default flow trigger setting of 0.6 l/ min
2.14 Modified operation of Main Power Fail alarm
The default setting for the flow trigger in the flow waveform window has been reduced from 2 l/min to 0.6 l/min.
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.
2.12 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. 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
For further information see section ’14.1.16.4 Fluctuation of measured Vte’ on page 70.
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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 FiO2 control renamed O2% FiO2 control has been renamed O2%
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) • O2% • 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.
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.
The user turns ON the backup breaths function. 3.1.2 CPAP with TTVplus (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
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3.3 CMV
3.4 PTV
Continuous Mandatory Ventilation
Patient Triggered Ventilation
In this mode the inspiratory cycle is initiated by the ventilator at a set BPM rate. The breaths are time cycled.
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:• BPM
The User sets the following:-
• Positive End Expired Pressure (PEEP)
• Positive End Expired Pressure (PEEP)
• Peak Inspiratory Pressure (PIP)
• Peak Inspiratory Pressure (PIP)
• Inspiratory Time (Ti)
• Inspiratory Time (Ti)
• O 2% • High and low pressure alarm thresholds
• Backup breath rate (Backup)
• Tidal volume, high and low alarm thresholds • Minute volume, high and low alarm thresholds 3.3.1 CMV with TTVplus (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.
• 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
The User sets the following:-
• Minute volume, high and low alarm thresholds
• Enables Targeted Tidal Volume (TTV) and selects volume to be delivered (Vte)
*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.
• Max PIP
3.4.1 PTV with TTVplus (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
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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.
3.5.1 PSV with TTVplus (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
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. Note: If the user sets the termination sensitivity to OFF the PSV mode behaves as PTV. 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)* • O2% • 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 *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.
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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. Time windows
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, O2%. Un-supported patient breath below trigger threshold
Assist windows
SIMV breath
Supported triggered breath
SIMV breath
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. 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.
Inspiratory time Time window =
60 BPM
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 *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.
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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 TTVplus (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
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) • O2% • 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) • O2% • High and low alarm pressure thresholds • Tidal volume, high and low alarm thresholds • Minute volume high and low alarm thresholds
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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 with apnoea backup
Time trigger
Pressure limit
Time cycled
CPAP with TTVplus
Time trigger
Volume limit
Time cycled
CMV
Time trigger
Pressure limit
Time cycled
CMV with TTVplus
Time trigger
Volume limit
Time cycled
PTV
Flow or pressure or time trigger
Pressure limit
Time cycled
PTV with TTVplus
Flow or pressure or time trigger
Volume limit
Time cycled
PSV
Flow or time trigger
Pressure limit
Flow cycled
PSV with TTVplus
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 TTVplus
Flow or pressure or time trigger
Volume limit
Time cycled
CPAP
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3.10 Detailed description of TTVplus , HFO MAP Compensation & Automatic Leak Compensation in PSV modes 3.10.1 TTVplus TTVplus 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 TTVplus 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.
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. Note: HFO mean compensation cannot be disabled whilst in a ventilatory mode.
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 recalibration) 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. Spontaneous breath volumes are ignored for the purposes of control. If SIMV+PSV is used with TTVplus 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 TTVplus 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%.
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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. Note: The SLE5000 and SLE4000 ventilators have different pneumatic units. See the pneumatic schematics on page 182. The exhalation block mounts onto two jet ports one forward/reverse and one mean pressure.
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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.