Instructions for Use
205 Pages
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SLE5000 Instructions for use V5 - Model P & R ventilators
When the smallest thing matters
SLE Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL United Kingdom
Telephone: +44 (0)20 8681 1414 Fax:
+44 (0)20 8649 8570
E-mail:
Web site:
www.sle.co.uk
This manual is only to be used with: SLE5000 Model P1/P2 and R1/R2 infant ventilators.
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.
Distributor
© Copyright SLE 10/09/2019 Document ref: UM157/UK Issue 3 UM157/UK
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How To Use The SLE5000 Infant Ventilator The warnings on pages 22 to 25 must be read and understood before using the SLE5000 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 66.
2
PERFORM THE PRE-USE TEST: Page 62.
3
SETUP THE VENTILATOR IN THE CHOSEN MODE: Page 82.
4
THE VENTILATOR IS READY FOR USE.
For troubleshooting see “Troubleshooting Chart” on page 110. For more technical data see “Technical information” section on page 119. For more installation information see “Installation” on page 120.
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Contents
4. User/Owner Responsibility ...19
10.5.1 Oxygen Alarm Test ...36 10.6 Services Panel...36 10.6.1 Flow ...37 10.6.2 Oxygen ...37 10.6.3 Wave Shaping ...37 10.6.4 Alarm Volume ...37 10.6.5 Patient Leak Alarm Limit...37 10.6.6 More Options Panel ...37 10.6.7 Language Toggle...38 10.6.8 Waveform Display Sync...38 10.6.9 Set Time and Date...38 10.6.10 Version Information Panel ...39 10.6.11 Monitor Services ...39 10.6.12 Controller Services ...39 10.7 Mode Panel Functions in a Ventilation Mode ...40 10.7.1 Standby Button (All modes) ...41 10.7.2 Apnoea Setup for CPAP ...41 10.7.3 Apnoea Setup for PTV & PSV and SIMV ...42 10.7.4 TTVplus for CPAP, PSV, PTV & SIMV...42 10.7.5 Set Trigger for CPAP, PSV, PTV & SIMV ...43 10.7.6 Pressure Support in PSV...43 10.7.7 Pressure Support in SIMV ...43 10.7.8 HFO Activity (Only available with HFO option)...43 10.8 Alarm Panel ...44 10.9 Default Waveform Windows ...45 10.10 Alarm and Breath Detection Thresholds...45 10.11 How to Set an Alarm Threshold...46 10.12 Ventilation Parameters ...48 10.13 Lung Mechanics and Measurement Panel49 10.14 The Pause Button ...50 10.15 Night Button and Screen Lock ...50
5. Warnings ...22
11. Loops, Trends & Waveforms ...52
5.1 Operational Warnings...22 5.1.1 General...22
11.1 Waveforms...52 11.2 Loops ...53 11.2.1 Capturing, Retrieving & Deleting Loops.53 11.3 Trends...54 11.3.1 Minute Volume trend...54 11.3.2 Description of Trend Windows...54
1. Introduction ...10 1.1 1.2 1.3
About This Manual...10 Intended Use ...10 Intended Users ...10
2. Description of the Ventilation Modes ...11 2.1 CPAP (with a flow sensor)...11 2.1.1 CPAP with Apnoea Backup ...11 2.1.2 CPAP with TTVplus for Backup Breaths. .11 2.2 CPAP (without a flow sensor)...11 2.3 CMV...12 2.3.1 CMV with TTVplus...12 2.4 PTV...12 2.4.1 PTV with TTVplus...12 2.5 PSV ...13 2.5.1 PSV with TTVplus ...13 2.6 SIMV...14 2.6.1 SIMV with PSV ...14 2.6.2 SIMV with TTVplus ...14 2.7 HFO (Only available with HFO option) ...15 2.8 HFO+CMV (Only available with HFO option) ...15 2.9 Overview of Conventional Ventilation Modes ...16 2.10 Detailed description of TTVplus , HFO MAP Compensation & Automatic Leak Compensation in PSV modes...17 2.10.1 TTVplus ...17 2.10.2 Automatic Leak Compensation in PSV modes17 2.10.3 HFO mean compensation (Only available with HFO option)17 3. Technical Description ...18
6. Warnings - clinical ...25 6.1 Monitoring...25 6.1.1 Clinical - invasive...25 7. Cautions - general ...25 7.1
Cautions - clinical ...26
8. Ventilator Description ...28 9. Description of Symbols, Buttons and Indicators ...31 10. User Interface ...34 10.1 User Interface Sections ...34 10.2 Description of User Interface Indicators ...34 10.3 Description of User Interface Controls...34 10.3.1 Examples of Control Use...34 10.4 Description of the Mode Panel in Ventilation Off Mode...36 10.5 Mode Select Button ...36
12. Ventilator Set-up ...56 12.1 Preparing the Ventilator for Use ...56 12.2 Ventilator - patient & operator position ...57 12.3 Ventilator Power Up and Power Down. ...58 12.3.1 Mains power indicator...58 12.3.2 Powering up and down. ...58 12.3.3 Turning ON the ventilator...58 12.3.4 Turning OFF the ventilator...58 12.3.5 Isolation from mains supply ...58 12.4 Back-up Battery Charging...58 12.5 Battery indicator...59 12.5.1 Explanation of battery charging. ...59 12.6 Suspension of the “Main Power Fail” alarm. ...59
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12.7 Extended storage ... 60 12.7.1 Screw cap fuse holder ... 60 12.7.2 Drawer type fuse holder ... 60
15.3 Setting the Pressure Trigger Level in CPAP, SIMV, PTV and PSV ... 79
13. Pre-use test ... 62
16.1 Pre set-up checks... 82 16.2 Setting the O2%... 82 16.3 CPAP Set-up ... 83 16.3.1 Actions after connection to patient in CPAP ... 83 16.3.2 Interactive and limiting controls in CPAP ... 83 16.3.3 TTVplus (Volume targeting) of backup breaths in CPAP... 84 16.3.4 Ventilation without a flow sensor connected. ... 84 16.3.5 Ventilation with the Apnoea alarm turned “OFF”... 84 16.4 CMV Set-up... 85 16.4.1 Actions after connection to patient in CMV ... 85 16.4.2 Interactive and limiting controls in CMV 85 16.4.3 TTVplus (volume targeting) all mechanical breaths in CMV. ... 86 16.4.4 Ventilation without a flow sensor connected. ... 86 16.5 PTV Set-up... 87 16.5.1 Actions after connection to patient in PTV ... 87 16.5.2 Interactive and limiting controls in PTV. 88 16.5.3 TTVplus (Volume targeting) of all triggered and mechanical breaths in PTV. ... 88 16.5.4 Ventilation Without a Flow Sensor Connected. ... 88 16.6 PSV Set-up... 89 16.6.1 Actions After Connection to Patient in PSV ... 89 16.6.2 Interactive and limiting controls in PSV. 90 16.6.3 TTVplus (Volume targeting) of all triggered and mechanical breaths in PSV. ... 90 16.6.4 Ventilation Without a Flow Sensor Connected. ... 90 16.7 SIMV Set-up ... 91 16.7.1 Actions After Connection to Patient in SIMV ... 91 16.7.2 Interactive and limiting controls in SIMV. ... 92 16.7.3 TTVplus (Volume targeting) of all synchronized and mechanical breaths in SIMV. ... 92 16.7.4 Ventilation Without a Flow Sensor Connected. ... 93 16.8 HFO Only Set-up (Only available with HFO option) ... 94 16.8.1 Actions After Connection to Patient in HFO... 94 16.8.2 Interactive and limiting controls in HFO. 95 16.8.3 Ventilation Without a Flow Sensor Connected. ... 95 16.9 HFO+CMV Set-up (Only available with HFO option) ... 96
13.1 Pre-use test checklist ... 63 14. Operational Considerations ... 66 14.1 General ... 66 14.1.1 Ventilation Off Mode ... 66 14.1.2 CPAP Mode without a Flow Sensor and with the Apnoea alarm set to “OFF” ... 66 14.1.3 SIMV Mode without a Flow Sensor and with the Apnoea alarm set to “OFF ... 66 14.1.4 Gas Input Pressures ... 66 14.1.5 Mode Memory On Power Up ... 66 14.1.6 Backup Battery Power ... 66 14.1.7 Parameter Memory ... 67 14.1.8 BPM or Backup, Measured and Set Parameters ... 67 14.1.9 Tidal Volume Parameter Resolution ... 67 14.1.10 Displayed O2% ... 67 14.1.11 HFO mode, Mean & Delta P Parameters (Only available with HFO option) ... 67 14.1.12 HFO variable I:E ratio (Only available with HFO option) ... 67 14.1.13 HFO Mean compensation (Only available with HFO option) ... 67 14.1.14 Breath Detection ... 68 14.1.15 Targeted Tidal Volume, Vte (TTV) ... 68 14.1.16 Max Ti in PSV ... 68 14.1.17 Wave Shaping... 69 14.1.18 Suctioning (Closed suction). ... 69 14.1.19 Flow sensor removal for suctioning or recalibration, pausing ventilation ... 69 14.1.20 Flow sensor removal for suctioning or recalibration but continuing ventilation ... 70 14.1.21 BPM Tot. Measurement. ... 70 14.2 Alarms ... 71 14.2.1 High and Low Alarm Operation ... 71 14.2.2 Minute Volume Alarm Threshold... 72 14.2.3 Tidal Volume Alarm Threshold... 72 14.2.4 Cycle Fail Alarm Threshold ... 72 14.2.5 Sub-ambient Pressure Alarm in Non HFO Modes72 14.2.6 HFO Only Ventilator Set Threshold Alarms (Only available with HFO option) ... 72 14.2.7 Patient Leak Alarm... 73 14.2.8 Reset Contamination Alarm ... 73 14.3 Patient Circuits, Humidification and Nitric Oxide Therapy... 74 14.3.1 Autofeed Humidification chambers ... 74 14.3.2 Nitric Oxide Therapy ... 74 14.3.3 Nebulization of Medication ... 75 15. Flow and Pressure Triggering ... 78 15.1 Breath Detection Threshold (Flow Triggering) ... 78 15.2 Breath Trigger Sensitivity (Pressure Triggering)... 78
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16. Basic Set-up ... 82
16.9.1 Actions After Connection to Patient in HFO+CMV ...96 16.9.2 Limiting controls in HFO+CMV ...96 16.9.3 Ventilation Without a Flow Sensor Connected. ...96 17. N5402-REV2 & N5302 Flow Sensor ...98 17.1 Calibration of the Flow Sensor ...98 17.2 Cleaning and High Level Disinfection of the N5402-REV2 Sensor ...99 17.2.1 Cleaning ...99 17.2.2 Disinfection ...99 17.2.3 High level disinfection...99 18. Frequently Asked Questions ...102 18.1 Ventilator Related Questions...102 18.2 Mode Related Questions ...103 18.3 Patient Circuits ...104 19. Commonly Seen Alarms ...106 19.1 19.2 19.3 19.4 19.5
High Pressure...106 Low Pressure...106 Breath Not Detected ...106 Low Tidal Volume ...106 Unexpected Rise or drop in Mean P. (Only available with HFO option) ...106 19.6 Unexpected Rise or Drop in Max P. (Only available with HFO option) ...106 19.7 Unexpected Rise or Drop in Min P. (Only available with HFO option) ...106 19.8 Continuing Positive Pressure ...106 19.9 Leaking Fresh Gas ...107 19.10 High Patient Leak ...107 19.11 Clean Flow Sensor ...107 19.12 Faulty Flow Sensor...107 19.13 Flow Calibration Fail ...107 19.14 Calibrate Flow Sensor ...107 19.15 Apnoea ...107
24. Functional Testing & Preventative Maintenance Schedule ...125 24.1 Functional testing...125 24.2 Preventative Maintenance ...125 24.2.1 Preventative Maintenance Model P ...125 24.2.2 Preventative Maintenance Model R...125 24.3 Mains cable replacement...126 25. RS232 ...127 25.1 Cautions for RS232 ...127 25.2 Location of RS232 Port...127 25.3 Overview...127 25.3.1 Data and Pinout Description. ...127 25.3.2 Cable ...127 25.3.3 Parameter Descriptions and Format...128 25.3.4 List of Parameters...128 25.3.5 Table of Current Alarm Condition Codes. ...130 25.4 RS232 Connection Settings and Testing Data Output ...130 26. Alarms ...131 26.1 Alarm Protocols ...131 26.2 Alarm Sounds ...131 26.2.1 Un-recognized alarm condition ...131 26.2.2 Alarm log...131 26.2.3 Alarm type...131 26.3 Alarm descriptions and actions to be taken ...132 26.4 Software and System Fail Protocols...146 27. Bacterial Filters ...147 27.1 Bacterial filter, SLE Part Nº:N3029 (Autoclavable)...147 27.2 Bacterial filter, SLE Part Nº: N3587/N3588 (Single use)...147 28. Patient Circuits ...148
20.1 Ventilation Related Problems ...110 20.2 Ventilator Related Problems...112
28.1 28.2 28.3 28.4
21. Installation ...120
29. Cleaning and Disinfection ...152
21.0.1 Tools required for trolley assembly...120 21.1 Trolley assembly...120 21.2 Ventilator lifting points ...121 21.3 Ventilator mounting...121 21.4 Back-up battery connection ...121 21.5 Ventilator labelling ...121 21.6 Mains cable attachment...122 21.7 Water trap attachment ...122 21.8 Miscellaneous items ...122
29.1 Preparation of a New Ventilator...152 29.2 Cleaning and Disinfection of an In-service Ventilator...152 29.3 Cleaning & Disinfection...152 29.4 Cleaning Method...153 29.4.1 Ventilator...153 29.4.2 Flow Sensor...153 29.4.3 Exhalation block...153 29.4.4 Occlusion valve...153 29.5 Disinfection Method ...153 29.5.1 Ventilator...153 29.5.2 Flow Sensor...153 29.5.3 Exhalation block...153 29.6 High Level Disinfection Method ...153
20. Troubleshooting Chart ...110
22. Secondary Language Selection ...123 22.1 Activation of Language Selection Program ...123 23. Oxygen Calibration Routines ...124 23.1 One Point O2 Calibration ...124 23.2 Two Point O2 Calibration ...124
Warnings for Patient Circuit Use...148 Generic 10mm Re-usable Patient Circuit .149 Generic 10mm Single Use Patient Circuit 150 Generic Nitric Oxide Delivery Adaptor Kit .151
30. Technical Specification ...154 30.1 Mode of operation...154
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30.2 Operating Modes Conventional Ventilation ... 154 30.2.1 CPAP ... 154 30.2.2 CMV ... 154 30.2.3 PTV ... 155 30.2.4 PSV ... 155 30.2.5 SIMV ... 156 30.2.6 HFO Ventilation (Only available with HFO option) ... 156 30.2.7 HFO+CMV (Only available with HFO option) ... 157 30.3 Maximum limited Pressures ... 157 30.3.1 Controls (Via touchscreen display) ... 157 30.3.2 Controls... 159 30.4 Measurement ... 159 30.4.1 Flow sensor... 159 30.4.2 Flow ... 159 30.4.3 Volume ... 159 30.4.4 Volume controlled breath accuracy... 159 30.4.5 Pressure controlled breath accuracy ... 159 30.4.6 Accuracy of volume monitoring ... 159 30.5 Measured parameters ... 159 30.5.1 Measurement uncertainties... 161 30.6 Exhalation Block Port Jet Sizes ... 161 30.7 Patient circuits... 161 30.8 Breathing system filters... 161 30.8.1 N3029 ... 161 30.8.2 N3587 ... 161 30.8.3 N3588 ... 161 30.9 Alarms ... 162 30.9.1 User settable Alarms... 162 30.9.2 Obligatory Alarms (non adjustable by user) ... 162 30.10 Outputs... 162 30.11 GMDN classification number... 163 30.12 IP rating... 163 30.13 Gas supplies ... 163 30.13.1 Oxygen supply ... 163 30.13.2 Air supply ... 163 30.13.3 Input pressures and ventilator performance ... 163 30.14 Power, Dimensions, Classification etc. ... 164 30.14.1 Service life ... 164 30.14.2 Operating Environment: ... 164 30.14.3 Connectors... 164 30.15 Classification ... 164 30.16 Environmental Storage Conditions... 164 31. Functional Testing ... 166 31.1 Functional testing ... 166 31.1.1 Complete Power Fail Alarm Test. ... 166 31.1.2 Back-up alarm speaker test ... 167 31.1.3 Setting O2% ... 167 31.1.4 Functional Testing without a Flow Sensor ... 167 31.1.5 Calibration of the Flow sensor ... 167 31.1.6 Oxygen Alarm Test ... 168 31.1.7 Occlusion valve test ... 168 31.1.8 Function and Alarm Testing ... 169 31.1.9 High Pressure Alarm ... 171
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31.1.10 Low Pressure Alarm ... 171 31.1.11 Breath Not Detected Alarm ... 172 31.1.12 Leak / Block Alarm ... 172 31.1.13 Mains Failure Alarm ... 173 31.1.14 Gas Supply Alarms ... 173 31.1.15 Flow Sensor Disconnect Alarm ... 174 31.1.16 Cycle Fail Alarm ... 174 31.1.17 Functional Test of HFO Mode ... 179 31.1.18 Functional Test of HFO+CMV Mode ... 181 31.1.19 Pressure Change Alarm ... 182 32. EMC compliance ... 184 32.1 32.2 32.3 32.4
Emissions test compliance levels... 184 Immunity tests compliance levels... 184 Warnings - EMC ... 185 Cautions - EMC ... 185
33. Pneumatic Unit Schematic SLE5000 Model R (No HFO option) ... 186 34. Pneumatic Unit Schematic SLE5000 Model P (With HFO option) ... 187 35. Patient circuit pneumatic diagrams ... 188 36. Ventilator Labelling ... 189 36.1 SLE5000 model R ... 189 36.2 SLE5000 Model P ... 190 37. Training (User) ... 191 38. Training (service) ... 191 39. Consumables and Accessories ... 194 40. Glossary of Abbreviations Used in this Manual ... 200 41. Index ... 201
Introduction
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1. Introduction
1.2 Intended Use
1.1 About This Manual
The ventilator is designed for use on patients up to 20kg, in conventional ventilation.
This user manual details the operation of the SLE5000 infant ventilator. The SLE5000 is available with HFO modes as an option. The user manual will from this point onwards refer to the SLE5000 as “the ventilator”. The following are the external differences between the SLE5000 ventilator and the SLE5000 with HFO. A. Overlays (SLE5000 overlays are dark green and the SLE5000 with HFO overlays are blue grey,). B. Installed software. (Start up screens and Mode select panels.)
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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The high frequency oscillation ventilation (Only available with HFO option) can be used on patients up to 20kg, dependant on lung condition. The ventilator is designed for “Continuous Operation”.
1.3 Intended Users The ventilator is intended to be used in clinical application only by appropriately trained medical personnel and operated only by trained technicians during maintenance and service.In this manual they will be referred to as the “User”.
2. 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 as a high frequency oscillation ventilator (Only available with HFO option).
2.2 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
2.1 CPAP (with a flow sensor)
• Manual Breath parameters (Ti and PIP)
Continuous Positive Airway Pressure
• O 2% • High and low pressure alarm thresholds
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 2.1.1 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.
See “CPAP Mode without a Flow Sensor and with the Apnoea alarm set to “OFF”” on page 66 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. 2.1.2 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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2.3 CMV
2.4 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 2.3.1 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
2.4.1 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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2.5 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.
2.5.1 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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2.6 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
2.6.1 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%.
SIMV breath
Assist windows
Un-supported patient breath below trigger threshold
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) 2.6.2 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
2.7 HFO (Only available with HFO option) 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
2.8 HFO+CMV (Only available with HFO option) 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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2.9 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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2.10 Detailed description of TTVplus , HFO MAP Compensation & Automatic Leak Compensation in PSV modes 2.10.1 TTVplus TTVplus is based upon providing a stable expired volume at the lowest possible pressure at the set Ti. 2.10.1.1 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.
2.10.3 HFO mean compensation (Only available with HFO option) 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. 2.10.2 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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3. 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 the gas is controlled by two pressure regulators that produce positive and negative gas flows via the forward and reverse jets. For oscillatory ventilation (Only available with HFO option) 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 SLE5000 with HFO option ventilators, have different pneumatic units. See the pneumatic schematics on page 186. 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.
4. User/Owner Responsibility The ventilator and the authorized accessories for it are designed to be used in accordance with supplied manual and instructions. This equipment must be periodically checked, recalibrated, maintained and components repaired and replaced when necessary for the equipment to operate safely and reliably. Parts that have failed, in whole or in part, or exhibit excessive wear, or are contaminated, or are otherwise at the end of their useful life, should not be used and must be replaced immediately with parts supplied by SLE, or parts which are otherwise approved by SLE. Equipment which is not functioning correctly or is otherwise in need of repair or maintenance must not be used until all necessary repairs and/or maintenance have been completed and a factory authorized service representative has certified that the equipment is fit and ready for use. This equipment, its accessories or component parts should not be modified. The use of non-approved parts or accessories will invalidate the warranty. The owner/user of this equipment shall have the sole responsibility and liability for any damage or injury to persons or property (including the equipment itself) resulting from operation not in accordance with the operating instructions, or from faulty maintenance not in accordance with the authorized maintenance instructions, or from repair by anyone other than the factory authorized service representative, or from unauthorized modification of the equipment or accessories, or from the use of components or accessories that have been either damaged or not authorized for use with this equipment by the manufacturer.
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