Instructions for Use
286 Pages
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SLE6000 Instructions for use V2.0
When the smallest thing matters
This manual is only to be used with: SLE6000 infant ventilators.
SLE Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL
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. OxyGenie® is a registered trade mark in the EEA.
Telephone: +44 (0)20 8681 1414 Fax:
+44 (0)20 8649 8570
E-mail:
Web site:
www.sle.co.uk
Distributor
© Copyright SLE 18/07/2018 Document ref: UM165 Issue 2 UM165/UK
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Fast index
Fast index
This index allows users to move directly to the areas of interest. A full contents page is available on page 5. Section
Page
Patient circuit selection for invasive ventilation and modification for non invasive ventilation
50
Ventilator setup Invasive ventilation
66
Ventilator setup Non invasive ventilation - Dual limb patient circuit
82
Ventilator setup Non invasive ventilation - Single limb patient circuit
90
Ventilator setup Non invasive ventilation - High flow nasal cannula therapy
94
Invasive mode basic operation CPAP
66
CMV
68
PTV
70
PSV
72
SIMV
74
HFOV
76
HFOV+CMV
78
Non invasive mode basic operation - Dual limb patient circuit nCPAP
82
NIPPV
84
NIPPV Tr.
86
nHFOV
88
Non invasive mode basic operation - Single limb patient circuit NCPAP
90
DuoPAP
92
O2 therapy
94
Technical information OxyGenie®
110
SpO2 & etCO2 sensors
98
Description of user interface
128
Technical data
147
Troubleshooting
240
Functional testing
248
User Preferences
262
Installation instructions
256
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Fast index This page is intentionally left blank.
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Contents
Contents 1.1 Software modules (V2.0)... 14
7.5 Cautions - general ... 28 7.5.1 Bacterial filters... 29 7.5.2 Flow sensor ... 29 7.6 Cautions - clinical ... 29
2. Description of the Ventilation Modes (Invasive) ...15
8. Warnings & Cautions - External sensors ... 29
2.1 CPAP... 15 2.2 CMV ... 16 2.3 PTV ... 16 2.4 PSV ... 17 2.5 SIMV ... 17 2.6 HFOV ... 18 2.7 HFOV+CMV ... 19
8.1 Warnings for Masimo SET® ... 29 8.2 Cautions for Masimo SET®... 30 8.2.1 General... 30 8.2.2 Cleaning ... 30 8.2.3 Cautions for alarms ... 30 8.2.4 Cautions for measurements ... 31 8.2.5 Cautions for Masimo sensors... 32 8.3 Warnings for Oridion Micropod™ ... 33 8.4 Cautions for Oridion Micropod™ ... 34
1. Introduction ... 14
3. Description of the Ventilation Modes (Non Invasive - Dual limb patient circuits) ...19
9. Warnings & Cautions OxyGenie® ... 35
3.1 nCPAP... 19 3.2 NIPPV ... 19 3.3 NIPPV Tr. ... 20 3.4 nHFOV ... 21
9.1 Warnings for OxyGenie® ... 35 9.2 Cautions for OxyGenie® ... 35 9.3 Clinical warnings ... 35
10. Ventilator layout ... 38
4. Description of the Ventilation Modes (Non Invasive - Single limb patient circuits) ...21
10.1 Front ... 38 10.2 Rear... 39
4.1 nCPAP... 21 4.2 DuoPAP... 22
11. Ventilator basic setup ... 42 11.1 Pre-use Inspection... 42 11.2 Connection of equipotential bonding cable... 42 11.3 Connection of mains power ... 42 11.3.1 IEC/BS 1363/A3 specification power leads... 42 11.3.2 Schuko and NEMA specification power leads... 42 11.4 Connection of 24V DC auxiliary power ... 42 11.4.1 Mains or auxiliary power supply - power switch status indicator ... 43 11.5 Fitting the silencer and exhalation block... 43 11.6 Gas connections ... 43 11.7 Ventilator - patient & operator position... 43 11.8 Turning the ventilator On ... 44 11.8.1 With mains connected ... 44 11.8.2 Without mains connected ... 44 11.8.3 With DC power connected ... 44 11.9 Pre-use functional test ... 44 11.9.1 Power on self test ... 44 11.9.2 Reserve power check ... 44 11.9.3 Patient circuit selection ... 45 11.9.4 Pre-functional test checks... 45 11.9.5 Functional testing (Invasive dual limb)... 45
5. Description of the Ventilation Modes (Non Invasive - O2 cannula) ...22 5.1 O2 therapy ... 22
6. Intended use of the SLE6000 ... 24 6.1 Summary statement ... 24 6.1.1 Medical indication... 24 6.1.2 Medical contraindication... 24 6.1.3 Patient type ... 24 6.1.4 Body part under treatment ... 24 6.1.5 Clinical therapy... 24 6.1.6 Main User Profile... 24 6.2 Condition of use ... 24
7. Warnings & Cautions - Ventilator 26 7.1 Warnings - general ... 26 7.2 Warnings - patient circuit & humidifier... 27 7.3 Warnings - nCPAP (single Limb)... 27 7.4 Warnings - clinical ... 28 7.4.1 Monitoring ... 28 7.4.2 Clinical - invasive ... 28 7.4.3 Clinical - non invasive ... 28
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Contents 11.9.6 Functional testing (Non invasive dual limb) ... 46 11.9.7 Functional testing (Non invasive single limb) 46 11.10 Turning the ventilator Off ... 47 11.10.1 Isolation from mains supply... 47
13.4 PSV ... 72 13.5 SIMV... 74 13.6 HFOV ... 76 13.7 HFOV+CMV ... 78 13.8 Common warnings ... 80 13.9 Common cautions ... 80 13.9.1 Common alternate functions (Conventional ventilation) ... 80 13.9.1.1 Manual breath or Inspiratory hold... 80 13.9.1.2 O2 Boost or O2 suction... 80 13.9.2 Common alternate functions (High frequency ventilation) ... 80 13.9.2.1 Sigh or Sigh hold ... 80 13.9.2.2 O2 Boost or O2 suction... 80 13.10 Ventilation without a flow sensor ... 80
12. Patient circuit selection ... 50 12.1 Type of ventilation ... 50 12.1.1 Invasive ... 50 12.1.2 Non-Invasive (Dual limb)... 50 12.1.3 Non-Invasive (Single limb) ... 50 12.1.4 Non-Invasive O2 therapy (Single limb) . 50 12.1.4.1 Patient circuit selection ... 50 12.2 Assembly of BC6188 (Ø10 mm) or BC6198 (Ø15 mm) patient circuit... 50 12.2.1 Bacterial filters... 50 12.2.2 Humidification chamber... 51 12.2.3 Fitting the temperature probes to a BC6188 patient circuit ... 52 12.2.4 Fitting the temperature probes to a BC6198 patient circuit ... 52 12.2.5 Fitting the flow sensor to a BC6188 patient circuit... 53 12.2.6 Fitting the flow sensor to a BC6198 patient circuit... 53 12.2.7 Fitting the test lung... 53 12.3 Assembly of BC6188/DHW patient circuit 54 12.3.1 Bacterial filters... 54 12.3.2 Humidification chamber... 54 12.3.3 Fitting the test lung... 56 12.4 Modification of BC6188 or BC6188/DHW circuits for non-invasive dual limb ventilation. .. 57 12.4.1 Fitting a dual limb nCPAP generator. ... 57 12.5 Modification of BC6188 or BC6188/DHW circuits for non-invasive single limb ventilation. 58 12.5.1 Bacterial filters... 58 12.5.2 Humidification chamber... 58 12.5.3 Fitting the temperature probes ... 59 12.5.4 Fitting a single limb nCPAP generator... 60 12.6 Modification of BC6188 or BC6188/DHW circuits for non-invasive single limb O2 therapy. ... 61 12.6.1 Bacterial filters... 61 12.6.2 Humidification chamber... 61 12.6.3 Fitting the temperature probes ... 62 12.6.4 Fitting a oxygen therapy nasal cannula. 63
14. Non-invasive - Dual limb ... 82 14.1 nCPAP D ... 82 14.2 NIPPV D ... 84 14.3 NIPPV Tr. ... 86 14.4 nHFOV ... 88
15. Non-invasive - Single limb ... 90 15.1 nCPAP S ... 90 15.2 DuoPAP... 92 15.3 O2 therapy... 94 15.4 Common warnings ... 96 15.5 Common cautions ... 96 15.6 Common note... 96
16. SpO2 and etCO2 monitoring ... 98 16.1 SpO2 monitoring (Masimo SET) ... 98 16.1.1 Principle of Operation... 98 16.2 Masimo SET® Connection ... 99 16.2.1 Connection to ventilator... 99 16.2.2 Disconnection... 99 16.2.3 Selection of Masimo SET® Sensors... 99 16.2.4 Sensor application sites ... 99 16.2.5 Connection of a sensor ... 99 16.2.6 Disconnection... 99 16.3 Configuration ... 100 16.3.1 SpO2 monitoring ON/OFF ... 100 16.3.2 FastSat™ ... 100 16.3.3 Averaging Time ... 100 16.3.4 Alarm Delay... 100 16.3.5 Auto O2: SpO2 Target range alarm limits. ... 100 16.3.6 SpO2 Sensitivity... 100 16.3.7 Rapid Desat... 101 16.3.8 Perf Index ... 101 16.4 Monitored values ... 101 16.5 SpO2 alarms thresholds ... 101
13. Ventilation - Invasive ...66 13.1 CPAP... 66 13.2 CMV ... 68 13.3 PTV ... 70
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Contents 16.6 SpO2 Waveform and display options... 101 16.7 Standard Waveform display option... 102 16.7.0.1 SpO2 and etCO2 dual waveform display 102 16.8 SpO2Waveform display option ... 102 16.8.1 SpO2 Waveform in O2 therapy ... 103 16.9 SpO2 module testing ... 103 16.10 Operation during mains power interruption (Mains power fail) ... 103 16.11 EtCO2 monitoring (MicroPod™) ... 104 16.11.1 Principle of Operation ... 104 16.11.2 Connection to ventilator... 104 16.11.3 Initialization Time... 104 16.11.4 Disconnection ... 104 16.11.5 Mounting of module ... 104 16.11.6 Connection of a FilterLine™ ... 105 16.12 Configuration... 105 16.12.1 EtCO2 Monitoring ... 105 16.12.2 Pump control ... 105 16.12.3 Breath absence alarm time ... 105 16.12.4 Device information ... 105 16.13 Waveforms ... 106 16.13.0.1 EtCO2 and SpO2 dual waveform display ... 106 16.14 Monitored values... 106 16.15 EtCO2 alarms thresholds ... 106 16.16 EtCO2module testing ... 106 16.17 Operation during mains power interruption (Mains power fail) ... 107 16.18 Cleaning the MicroPod™ Enclosure ... 107
18.1.2 Apnoea alarm set to “Off” ... 116 18.1.3 Reserve power source ... 116 18.1.4 Parameter Memory... 116 18.1.5 HFO variable I:E ratio (Only available with HFOV and nHFOV options)... 116 18.1.6 Trigger sensitivity... 117 18.1.7 Volume Targeted Ventilation, Vte (VTV) 117 18.1.7.1 Ti... 117 18.1.7.2 Vte Target Resolution ... 117 18.1.8 Max Ti in PSV... 117 18.1.9 Suctioning (Closed suction)... 117 18.1.10 VTV & HFOV ... 117 18.1.10.1 Vte Target Resolution ... 117 18.2 O2 Suction... 118 18.3 O2 Boost ... 119 18.4 Alarm thresholds ... 120 18.4.1 Alarm thresholds for conventional modes (invasive and non invasive - dual limb). ... 120 18.4.2 Alarm thresholds for Oscillatory modes (invasive and non invasive - dual limb). ... 120 18.4.2.1 HFOV & nHFOV ... 120 18.4.2.2 HFOV+CMV (invasive - dual limb) ... 121 18.4.3 Alarm thresholds for conventional modes (non invasive - single limb). ... 122 18.4.4 High pressure threshold alarm operation. ... 122 18.4.5 Low pressure threshold alarm operation123 18.5 Patient Circuits, Humidification and Nitric Oxide Therapy ... 123 18.5.1 Autofeed Humidification chambers... 123 18.5.2 Nitric Oxide Therapy... 124 18.5.3 Nebulization of Medication ... 124 18.5.3.1 Nebulization using Aerogen® ... 124 18.6 Using the SLE6000 with SLE500E and SLE500S medical air compressors ... 125
17. OxyGenie® ...110 17.1 Introduction ... 110 17.1.1 OxyGenie® modes of operation ... 110 17.1.1.1 Auto mode... 110 17.1.1.2 Fallback mode:... 110 17.1.1.3 Manual override ... 111 17.1.1.4 Inactive mode... 111 17.2 OxyGenie® Fall back mode... 111 17.2.1 Checking the OxyGenie® response ... 111 17.2.2 Activating OxyGenie®... 111 17.2.3 Deactivating OxyGenie® ... 111 17.2.4 Activating manual override... 112 17.2.5 Changing the SpO2 target range... 112 17.2.6 Averaging Time ... 112 17.3 SpO2Waveform display option and OxyGenie® ... 112 17.4 OxyGenie® and O2 Boost ... 113 17.5 OxyGenie® and O2 Suction ... 113
19. User interface description ... 128 19.1 Standby mode ... 128 19.1.1 User interface ... 128 19.1.2 Information panel... 128 19.1.3 Information bar ... 128 19.1.4 Generic button/panel functions... 128 19.1.4.1 Panel functions... 128 19.1.4.2 Parameter time out... 128 19.1.4.3 Panel time out ... 128 19.1.4.4 Button states ... 128 19.1.4.5 Mode button ... 128 19.1.4.6 Start/Resume Ventilation button ... 128 19.1.4.7 Alarms ... 128 19.1.4.8 Utilities button... 128 19.1.4.9 Calibration & Utilities button ... 129 19.1.4.10 Layout button... 129 19.1.4.11 Multi function button ... 129
18. Operational features ...116 18.1 General ... 116 18.1.1 Standby Mode ... 116
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Contents
20. Technical description ... 148
19.1.5 Mode button & Start/Resume Ventilation button ... 129 19.1.6 Alarm button ... 129 19.1.6.1 Limits tab ... 129 19.1.6.2 History tab ... 130 19.1.6.3 Loudness tab... 130 19.1.7 Utilities & Calibration & Utilities button .. 130 19.1.7.1 Sensors tab (without external sensor/s) ... 131 19.1.7.2 Sensors tab (with external sensor/s).. 131 19.1.7.3 Brightness tab ... 131 19.1.7.4 System Tab ... 132 19.1.7.5 Data tab... 133 19.1.7.6 Downloading screen captures... 134 19.1.8 Layout Tab... 135 19.1.8.1 Waveforms ... 136 19.1.8.2 Loops ... 136 19.1.9 Capturing, Retrieving & Deleting Loops. 137 19.1.9.1 To capture Loops... 137 19.1.9.2 Trends ... 137 19.1.9.3 Single & double trend display... 138 19.1.9.4 Viewing trends... 138 19.2 Ventilation mode... 140 19.2.1 Alarm mute and pre-mute button ... 140 19.2.2 Parameters... 140 19.2.2.1 Parameter types ... 140 19.2.2.2 Parameter states... 140 19.2.2.3 Modifying a parameter ... 140 19.2.2.4 Turning “ON” a parameter function ... 140 19.2.3 Preview mode ... 141 19.2.4 Patient circuit selection ... 141 19.2.5 Monitored values... 141 19.2.5.1 Single column/double column layout.. 141 19.2.6 Alarms tab - ventilatory mode ... 142 19.2.6.1 Adjusting an alarm threshold... 142 19.2.6.2 Alarm auto tracking/auto set thresholds... 142 19.2.7 History and Loudness ... 143 19.2.8 Utilities tab - ventilatory mode ... 143 19.2.8.1 Flow sensor calibration ... 143 19.2.8.2 O2 calibration ... 144 19.2.9 Brightness tab - ventilatory mode... 144 19.2.10 System tab - ventilatory mode... 144 19.2.11 Data tab - ventilatory mode ... 144 19.2.12 Layout ... 144 19.2.13 Lock screen button... 144 19.2.14 Pause/play ... 144 19.2.15 Screen capture... 144 19.2.16 Alarm bar... 145 19.2.17 Mode specific controls... 145 19.2.17.1 Manual breath (Inspiratory Hold)... 145 19.2.17.2 Sigh (Sigh Hold) ... 145 19.2.18 Oscillation Pause ... 145 19.2.19 HFO Activity ... 145
21. Description of ventilatory modes (Invasive) ... 149 21.1 CPAP... 149 21.2 CMV ... 149 21.2.1 CMV & VTV ... 149 21.3 PTV ... 149 21.3.1 PTV & VTV ... 149 21.4 PSV ... 149 21.4.1 PSV & VTV... 149 21.5 SIMV... 149 21.5.1 SIMV with P Support ... 150 21.5.2 SIMV & VTV ... 150 21.6 HFOV ... 150 21.6.1 HFO & VTV ... 150 21.7 HFOV+CMV ... 150
22. Description of ventilatory modes (Non-invasive) ... 150 22.1 nCPAP (Dual and Single limb) ... 150 22.2 NIPPV (Dual limb) ... 150 22.3 NIPPV Tr. (Dual limb) ... 150 22.4 nHFOV (Dual limb only) ... 150 22.5 O2 Therapy (Single limb only) ... 150
23. Oxygen Calibration Routines ... 151 23.1 One Point O2 Calibration... 151 23.2 Two Point O2 Calibration ... 151
24. N5402-REV2 & N5302 flow sensor 152 24.1 Calibration of the Flow Sensor ... 152 24.2 Cleaning and high level disinfection of the N5402-REV2 Sensor... 153 24.2.1 Cleaning: ... 153 24.2.2 Disinfection:... 153 24.2.3 High level disinfection... 153
25. Technical specification ... 154 25.1 Operating Modes - Conventional Invasive Ventilation ... 154 25.1.1 CPAP mode... 154 25.1.2 CMV mode ... 154 25.1.3 PTV mode ... 155 25.1.4 PSV mode ... 155 25.1.5 SIMV mode... 156 25.1.6 HFOV mode ... 156 25.1.7 HFOV+CMV mode ... 157 25.2 Operating Modes Conventional Non Invasive Ventilation ... 157
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Contents 25.2.1 nCPAP D mode (Dual Limb)... 157 25.2.2 NIPPV D mode (Dual Limb) ... 158 25.2.3 NIPPV Tr. mode (Dual Limb)... 158 25.2.4 nHFOV mode (Dual Limb)... 158 25.2.5 nCPAP S mode (Single Limb) ... 159 25.2.6 O2 therapy (Single Limb) ... 159 25.2.7 OxyGenie ... 159 25.2.7.1 OxyGenie PCLCS attributes ... 159 25.3 Mode of operation ... 159 25.4 Controls... 159 25.4.1 Power Button ... 159 25.4.2 User Interface... 159 25.4.2.1 Buttons ... 159 25.4.2.2 Tabs... 162 25.4.2.3 Controls ... 162 25.5 Measurement ... 164 25.5.1 Flow sensor... 164 25.5.2 Flow ... 164 25.5.3 Volume ... 164 25.5.4 Volume controlled breath accuracy ... 164 25.5.5 Pressure controlled breath accuracy (Invasive Ventilation) ... 164 25.5.6 Pressure controlled breath accuracy (Noninvasive Ventilation) ... 164 25.5.7 Measured parameters ... 165 25.5.7.1 Oxygen Concentration ... 166 25.5.7.2 Pressure ... 166 25.5.7.3 Trends ... 166 25.5.7.4 Sound pressure level ... 166 25.5.7.5 Exhalation Block Port Jet Sizes ... 166 25.5.8 BS EN ISO 80601-2-12 Disclosure ... 166 25.5.9 Measurement uncertainties ... 167 25.6 Patient circuits ... 167 25.7 Breathing system filters ... 167 25.7.1 N3029... 167 25.7.2 N3587... 167 25.7.3 N3588... 167 25.8 Maximum limited Pressures ... 167 25.9 Gas supplies ... 167 25.9.1 Oxygen supply ... 167 25.9.2 Air supply ... 167 25.9.2.1 Connectors ... 168 25.9.3 Flows ... 168 25.10 Service life... 168 25.11 Power, Dimensions, Classification... 168 25.11.1 Power AC ... 168 25.11.2 Power DC ... 168 25.12 Operating Environment ... 168 25.12.1 Connectors ... 168 25.13 Classification (Electrical) ... 168 25.14 GMDN classification number... 168 25.15 IP rating... 168
25.16 Environmental Storage Conditions ... 168
26. Output ports (Electrical) ... 169 26.1 RS232 port ... 169 26.1.1 SLE6000 basic data output. ... 169 26.1.2 SLE6000 basic data output Specifications ... 169 26.1.3 Communications Settings... 169 26.1.3.1 Data Rate & Size ... 169 26.1.3.2 Data Format ... 169 26.1.4 Data Layout ... 169 26.1.5 Data Format ... 170 26.2 Vuelink & Intellibridge ... 175 26.2.1 Connecting to the VueLink patient monitor ... 175 26.2.2 Connecting to the IntelliBridge patient monitor ... 175 26.2.3 Parameter Descriptions... 176 26.2.4 Alarm messages... 177 26.2.5 Waveform ... 179 26.2.6 VueLink Task Window Layout... 179 26.3 Nurse call ... 180 26.3.1 Nurse call delay... 180 26.4 Ethernet... 180 26.5 USB (Data) ... 180 26.6 USB (Power) ... 180 26.7 External Monitor ... 180
27. Input ports (Electrical) ... 181 27.1 SpO2 and etCO2 ... 181 27.2 Flow sensor ... 181 27.3 DC 24V... 181
28. Sensor Specifications ... 181 28.1 Masimo SET® ... 181 28.1.1 Functional SpO2 (%)... 181 28.1.2 Pulse rate (BPM) ... 181 28.1.3 Perfusion index (%) ... 182 28.1.3.1 Senor Wavelength range... 182 28.1.4 Accuracy notes... 182 28.1.5 Environmental ... 183 28.1.5.1 Operating Conditions... 183 28.1.5.2 Storage Conditions ... 183 28.1.5.3 Implied license statement ... 183 28.2 MicroPod™... 183 28.2.1 Alarm limits ... 184 28.2.2 Measurement formats ... 184 28.2.3 Calculation methods for Capnography .. 184 28.2.4 Environmental ... 184 28.2.4.1 Operating Conditions... 184 28.2.4.2 Storage Conditions ... 184 28.2.4.3 Trademarks ... 184
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Contents
29. Alarms ... 185
37. Planned preventative Maintenance (PPM) ... 248
29.1 Alarm Prioritization ... 185 29.1.1 Alarm Characteristics ... 185 29.1.2 Alarm sounder volume ... 185 29.1.3 Alarm log ... 185 29.2 Alarm Indicators characteristics ... 185 29.3 Alarm table ... 189 29.4 Hardware Fault 3. (Power supply fault table) ... 211 29.5 Hardware Fault 4. (Monitor memory fault table) ... 212 29.6 Hardware Fault 6. (Controller fault table) . 213 29.7 Hardware Fault 5 & 9. (Local voltage monitor fail fault table)... 213
37.1 PPM schedule ... 248 37.2 PPM kits ... 248 37.2.1 Kit A... 248 37.2.2 Kit B... 248 37.3 Kit part numbers ... 248 37.4 Mains cable replacement ... 248 37.5 MicroPod™ PPM... 249
38. Ventilator Functional testing ... 249 38.1 Alarm testing ... 249 38.1.1 High Oxygen/Low Oxygen/Loss of gas supply alarm test... 249 38.1.2 Obstruction alarm - Blocked fresh gas .. 250 38.1.3 Partial occlusion alarm - Continuing positive pressure ... 250 38.1.4 High Pressure alarm - High pressure threshold exceeded ... 250 38.1.5 Expired volume alarm - Tidal volume above/ below threshold ... 250 38.1.6 Volume alarm - Minute volume above/below threshold... 250 38.1.7 Power supply failure alarm - Main power fail and battery check ... 250 38.2 Performance testing. ... 251 38.2.1 Conventional ... 251 38.2.2 Oscillatory... 251
30. Sensor Alarms ...214 30.1 Alarm Priorities... 214 30.1.1 Status messages... 214 30.2 SpO2 monitoring (System alarms)... 215 30.3 SpO2 monitoring (Patient alarms)... 219 30.4 EtCO2 monitoring (System alarms) ... 220 30.5 EtCO2 monitoring (Patient alarms) ... 223
31. Sensor Status messages ... 225 31.1 SpO2 Status messages ... 225 31.2 EtCO2 Status messages ... 226
32. Cleaning and disinfection ... 229 32.1 Instructions... 229 32.2 External surface cleaning instructions... 229 32.3 External surface disinfection instructions . 230 32.4 Exhalation block cleaning instructions ... 230 32.5 Exhalation block disinfection instructions. 230 32.6 Silencer disinfection instructions ... 230 32.7 Gas jet ports disinfection... 230 32.8 Occlusion valve ... 230 32.9 Cleaning of main air intake filter. ... 230
39. External sensor functional testing ... 252 39.1 Masimo SET® ... 252 39.1.1 Masimo SET® Functional testing ... 252 39.1.2 Masimo SET® SpO2 and PR alarms ... 252 39.2 MicroPod™... 253 39.2.1 MicroPod™ Functional testing ... 253 39.2.2 MicroPod™ etCO2 alarm ... 253
33. EMC compliance ...231
40. Installation instructions ... 256
33.1 Electromagnetic immunity ... 232 33.2 Recommended separation distances. ... 234
40.0.1 Tools required for trolley assembly... 256 40.1 Unpacking. ... 256 40.2 Medicart assembly ... 257 40.2.1 Medicart kit contents ... 257 40.2.2 Assembly... 257 40.3 Ventilator unpacking ... 258 40.4 Ventilator lifting points ... 259 40.5 Ventilator assembly to Medicart ... 259 40.6 Mains cable attachment ... 260 40.7 Pre-use functional test... 260 40.8 Ventilator configuration... 260
34. Pneumatic unit diagram ...235 34.1 Patient circuit pneumatic diagrams ... 236
35. Software version identification .. 237 36. Troubleshooting Chart ...240 36.1 Ventilation Related Problems ... 240 36.2 Ventilator Related Problems... 242 36.3 Sensor Related Problems ... 245
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Contents
41. User preferences ...262 41.1 Accessing user preferences... 262 41.1.1 Parameters tab... 262 41.1.1.1 Parameters... 262 41.1.2 Ventilation tab... 263 41.1.3 Alarms tab ... 263 41.1.4 Interface tab ... 264 41.1.5 Regional tab ... 264 41.1.6 Save / Quit tab ... 264
42. SLE 6000 Event and patient log software ...266 42.1 Minimum system requirements ... 266 42.1.1 Memory stick requirements ... 266 42.2 Installation of software... 266 42.3 Downloading the Patient log or Event log 266 42.4 Export file formats ... 267 42.4.1 File types... 267 42.4.1.1 RealtimeLog ... 267 42.4.1.2 AlarmsLog ... 267 42.4.1.3 TrendsDataLog... 268 42.4.1.4 SystemLog ... 268 42.4.1.5 DebugLog... 268 42.4.1.6 Log records ... 268 42.5 Reading patient Log files (.dat) ... 268 42.6 Reading Patient Log files (.txt) ... 269 42.7 Reading Event Log files (.evt) ... 270 42.7.1 Event log ... 270 42.7.2 Debug log... 270
43. Training (User) ...271 44. Training (service) ...271 45. Consumables & Accessories ...274 46. Glossary ... 279 47. SLE6000 markings and symbols 281 47.1 Description of ventilator markings ... 281 47.2 Description of option markings... 282 47.3 Description of interface markings. ... 282 47.4 Description of Micropod™ markings. ... 284
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Introduction
Introduction
13
Introduction
1. Introduction
SLE6000 Single Limb NIV Software Module
The SLE6000 infant ventilator running version 2.0 software is modular in design. This release has 9 modules that fit into the core module.
This software module adds the facility to ventilate using nCPAP and DuoPAP with a single limb circuit.
The graphic below shows how all the modules when purchased interface with the core module.
SLE6000 NIPPV Tr. Software Module This software module adds the facility to ventilate using NIPPV with support of patient triggered breaths with a dual limb circuit. SLE6000 Oxygen Therapy Software Module This software module adds the facility to use nasal O2 therapy sets with a single limb circuit. SLE6000 VTV (Conventional Ventilation) Software Module This software module adds VTV to all of the conventional invasive monitoring modes. SLE6000 etCO2 Monitoring Software Module This software module adds etCO2 software that allows an Oridion MicroPod™ to interface with the SLE6000. It requires an Oridion MicroPod™ and neonatal sampling lines. SLE6000 Masimo SpO2 Monitoring Software Module This software module adds SpO2 software that allows a Masimo uSpO2 module to interface with the SLE6000. It requires a SLE uSpO2 cable (Masimo SET) and infant, neonatal and neonatal/paediatric SpO2 sensors.
All of the modules are software modules. Refer to the side of the ventilator to see installed options.
1.1
Software modules (V2.0)
SLE6000 OxyGenie® Software Module
Core Configuration Software Module Core software is installed on all SLE6000 ventilators and includes invasive modes (CPAP,CMV, PTV, PSV, SIMV) and non-invasive modes (nCPAP, NIPPV) as standard.
This software module adds the Auto-O2 system that is intended to control the inspired oxygen delivery, to keep the SpO2 of the patient within a predefined range of SpO2.
SLE6000 HFOV (including HFOV VTV) Software Module This software module adds HFOV to the SLE6000 allowing both invasive and non-invasive (dual limb) HFOV. Invasive HFOV includes VTV as standard.
14
Introduction SLE6000 IntelliBridge Software Module
2. Description of the Ventilation Modes (Invasive)
This software module adds the connectivity to the external monitoring systems provided by the Philips Vuelink and IntelliBridge modules.
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 HFOV option).
2.1 CPAP 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:• Ti (Inspiratory time) • CPAP • PIP • O 2% Additional features • RR backup • Rise time • Trigger Sensitivity (Flow or Pressure breath detection threshold) Alarms • High and low PIP • High and low CPAP • High RR • Apnoea time
(Can be turned OFF)
Alarms available when flow sensor connected • High and low Vte • High and low Vmin • Percentage leak
(Active when flow sensor connected)
Additional items • Manual breath or Inspiratory hold button Features with SpO2 module • Pleth waveform when selected • High and low SpO2 alarm thresholds • High and low PR alarm thresholds OxyGenie® + SpO2 module • SpO2 target range • High O2% alarm
15
+
Introduction Features with etCO2 module
2.3 PTV
• etCO2 waveform when selected
Patient Triggered Ventilation
• High and low etCO2 alarm thresholds
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.
2.2 CMV Continuous Mandatory Ventilation
User sets the following:-
In this mode the inspiratory cycle is initiated by the ventilator at a set RR rate. The breaths are time cycled.
• RR (Respiratory rate)
User sets the following:-
• PIP
• PEEP
• O 2%
• Ti (Inspiratory time) • PEEP
• PIP
Additional features
• RR (Respiratory rate)
• Rise time
• Ti (Inspiratory time) • O 2%
• Trigger Sensitivity (Flow or Pressure breath detection threshold)
Additional features
Alarms thresholds
• Rise time
• High and low PIP
Alarms thresholds
• High and low PEEP
• High and low PIP
• High RR
• High and low PEEP
• Apnoea time
Alarms available when flow sensor connected
Alarms available when flow sensor connected
• High and low Vte
• High and low Vte
• High and low Vmin
• High and low Vmin
• Percentage leak
• Percentage leak
Additional items
Additional items
• Manual breath or Inspiratory hold button
• Manual breath or Inspiratory hold button
Features with VTV module • VTV of CMV breaths
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(Can be turned OFF)
Features with VTV module • VTV of patient breaths
Features with SpO2 module • Pleth waveform when selected
Features with SpO2 module
• High and low SpO2 alarm thresholds
• Pleth waveform when selected
• High and low PR alarm thresholds
• High and low SpO2 alarm thresholds
OxyGenie® + SpO2 module
• High and low PR alarm thresholds
• SpO2 target range • High O2% alarm
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OxyGenie® + SpO2 module
Features with etCO2 module
• SpO2 target range • High O2% alarm
• etCO2 waveform when selected
Features with etCO2 module
• High and low etCO2 alarm thresholds
• etCO2 waveform when selected • High and low etCO2 alarm thresholds
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Introduction
2.4 PSV
Features with etCO2 module
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.
• etCO2 waveform when selected • High and low etCO2 alarm thresholds
2.5 SIMV Synchronised Intermittent Mandatory Ventilation The frequency of mandatory breaths is determined by the RR 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.
The termination sensitivity is also user adjustable from 0% - 50%. User sets the following:-
Time windows
• RR (Respiratory rate) • Max Ti (Maximum Inspiratory time.) • PEEP • PIP • O 2%
Assist windows
Additional features
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
• Rise time • Trigger Sensitivity (Flow or Pressure breath detection threshold) • Termination Sensitivity Alarms thresholds • High and low PIP • High and low PEEP • High RR • Apnoea time
(Can be turned OFF)
Alarms available when flow sensor connected • High and low Vte
Inspiratory time
• High and low Vmin • Percentage leak
Time window =
Additional items
60 RR
User sets the following:-
• Manual breath or Inspiratory hold button
Features with SpO2 module
• • • • •
• Pleth waveform when selected
Additional features
• High and low SpO2 alarm thresholds
• Rise time • Trigger Sensitivity (Flow or Pressure breath detection threshold) – The patient effort required for the ventilator to recognise the breath. • Pressure support
Features with VTV module • VTV of all breaths
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• High and low PR alarm thresholds OxyGenie® + SpO2 module • SpO2 target range
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• High O2% alarm
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RR (Respiratory rate) Ti (Inspiratory time) PEEP PIP O 2%
Introduction Alarms thresholds
2.6 HFOV
• High and low PIP • High and low PEEP • High RR
High Frequency Oscillation
• Apnoea time
In this mode, the ventilator shall deliver continuous high frequency oscillation. There is no patient interaction.
(Can be turned OFF)
Alarms available when flow sensor connected
User sets the following:-
• High and low Vte
• Frequency
• High and low Vmin
• I:E ratio
• Percentage leak
• MAP • Delta P
Features with VTV module • VTV of all breaths
• VTV
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• O 2% Additional features
Features with SpO2 module
• Sigh RR
• Pleth waveform when selected
• Sigh Ti
• High and low SpO2 alarm thresholds
• Sigh P
• High and low PR alarm thresholds
Alarms thresholds
OxyGenie® + SpO
• High and low Paw
2 module
• SpO2 target range • High O2% alarm
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Alarms available when flow sensor connected • High and low Vte • High and low Vmin
Features with etCO2 module
• Percentage leak
• etCO2 waveform when selected • High and low etCO2 alarm thresholds
Features with SpO2 module • Pleth waveform when selected • High and low SpO2 alarm thresholds • High and low PR alarm thresholds OxyGenie® + SpO2 module SpO2 target range • High O2% alarm
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Introduction
3. Description of the Ventilation Modes (Non Invasive - Dual limb patient circuits)
2.7 HFOV+CMV A combination of oscillations during the expiratory or inspiratory & expiratory phase of a time cycled, pressure limited breath in CMV mode.
3.1 nCPAP
User sets the following:-
Nasal Continuous Positive airway pressure.
• RR (Respiratory rate) • Ti (Inspiratory time)
The ventilator generates a continuous positive airway pressure at a level set by the User.
• Frequency • PEEP
User sets the following:-
• PIP
• Ti (Inspiratory time)
• Delta P
• CPAP
• O 2%
• PIP
Additional features
• O 2%
• HFOV activity
Additional features
Features with SpO2 module
• RR backup
• Pleth waveform when selected
• Rise time
• High and low SpO2 alarm thresholds
• Trigger Sensitivity Pressure breath detection threshold – The patient effort required for the ventilator to recognise the breath.
• High and low PR alarm thresholds OxyGenie® + SpO2 module • SpO2 target range
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Alarms
• High O2% alarm
• High and low PIP • High and low CPAP • High RR • Apnoea time
(Can be turned OFF)
Features with SpO2 module • Pleth waveform when selected • High and low SpO2 alarm thresholds • High and low PR alarm thresholds OxyGenie® + SpO2 module • SpO2 target range • High O2% alarm
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3.2 NIPPV Non invasive positive pressure ventilation. In this mode the inspiratory cycle is initiated by the ventilator at a set respiratory rate. The breaths are time cycled. User sets the following:• RR (Respiratory rate) • Ti (Inspiratory time) • PEEP • PIP • O 2%
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Introduction Additional features
3.3 NIPPV Tr.
• Rise time
Non invasive positive pressure ventilation Triggered
Alarms • High and low PIP
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 recognized.
• High and low PEEP Additional items • Manual breath or Inspiratory hold button
User sets the following:• RR (Respiratory rate)
Features with SpO2 module
• Ti (Inspiratory time)
• Pleth waveform when selected
• PEEP
• High and low SpO2 alarm thresholds
• PIP
• High and low PR alarm thresholds
• O 2%
OxyGenie® + SpO2 module
Additional features
• SpO2 target range • High O2% alarm
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• Rise time • Trigger Sensitivity Pressure breath detection threshold Alarms • High and low PIP • High and low PEEP Additional items • Manual breath or Inspiratory hold button Features with SpO2 module • Pleth waveform when selected • High and low SpO2 alarm thresholds • High and low PR alarm thresholds OxyGenie® + SpO2 module • SpO2 target range • High O2% alarm
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