Instructions for Use
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SLE6000 Instructions for use V2.0.97 & 2.0.98
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 02/07/2020 Document ref: UM165/UK Issue 12 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 SpO2 & etCO2 sensors
98
OxyGenie®
110
Description of user interface
128
Technical data
147
Troubleshooting
244
Functional testing
252
User Preferences
266
Installation instructions
260
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Fast index This page is intentionally left blank.
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Contents
Contents
8.2 Warnings - EMC ... 27 8.3 Cautions - EMC ... 27 8.4 Warnings - patient circuit & humidifier ... 27 8.5 Warnings - nCPAP (single Limb) ... 28 8.6 Warnings - clinical ... 28 8.6.1 Monitoring... 28 8.6.2 Clinical - invasive... 28 8.6.3 Clinical - non invasive... 28 8.7 Cautions - general ... 28 8.7.1 Bacterial filters... 29 8.7.2 Flow sensor ... 29 8.8 Cautions - clinical ... 29
1. Introduction ... 14 1.1 Software modules (V2.0)... 14
2. Identifying software and hardware. ...15 2.1 Pneumatic module identification for HFOV applicability... 15
3. Description of the Ventilation Modes (Invasive) ...16 3.1 CPAP... 16 3.2 CMV ... 16 3.3 PTV ... 17 3.4 PSV ... 17 3.5 SIMV ... 18 3.6 HFOV ... 19 3.7 HFOV+CMV ... 19
9. Warnings & Cautions - External sensors ... 29 9.1 Warnings for Masimo SET® ... 29 9.2 Cautions for Masimo SET® ... 30 9.2.1 General... 30 9.2.2 Cleaning ... 31 9.2.3 Cautions for alarms ... 31 9.2.4 Cautions for measurements ... 31 9.2.5 Cautions for Masimo sensors... 32 9.3 Warnings for Oridion Micropod™ ... 33 9.4 Cautions for Oridion Micropod™ ... 34
4. Description of the Ventilation Modes (Non Invasive - Dual limb patient circuits) ...20 4.1 nCPAP... 20 4.2 NIPPV ... 20 4.3 NIPPV Tr. ... 21 4.4 nHFOV ... 21
10. Warnings & Cautions - OxyGenie® ... 35 10.1 Warnings for OxyGenie® ... 35 10.2 Cautions for OxyGenie® ... 35 10.3 Clinical warnings ... 35
5. Description of the Ventilation Modes (Non Invasive - Single limb patient circuits) ...22
11. Ventilator layout ... 38
5.1 nCPAP... 22 5.2 DuoPAP... 22
11.1 Front ... 38 11.2 Rear ... 39
6. Description of the Ventilation Modes (Non Invasive - O2 cannula) ...22
12. Ventilator basic setup ... 42 12.1 Pre-use Inspection ... 42 12.2 Connection of equipotential bonding cable42 12.3 Connection of mains power... 42 12.3.1 IEC/BS 1363/A3 specification power leads... 42 12.3.2 Schuko and NEMA specification power leads... 42 12.4 Connection of 24V DC auxiliary power... 42 12.4.1 Mains or auxiliary power supply - power switch status indicator ... 43 12.5 Fitting the silencer and exhalation block .. 43 12.6 Gas connections... 43 12.7 Ventilator - patient & operator position ... 43 12.8 Turning the ventilator On ... 44 12.8.1 With mains connected ... 44 12.8.2 Without mains connected ... 44
6.1 O2 therapy ... 22
7. Intended use of the SLE6000 ... 24 7.1 Summary statement ... 24 7.1.1 Medical indication... 24 7.1.2 Medical contraindication... 24 7.1.3 Patient type ... 24 7.1.4 Body part under treatment ... 24 7.1.5 Clinical therapy... 24 7.1.6 Main User Profile... 24 7.2 Condition of use ... 24
8. Warnings & Cautions - Ventilator 26 8.1 Warnings - general ... 26
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Contents 13.6.4 Fitting a oxygen therapy nasal cannula. 63
12.8.3 With DC power connected ... 44 12.9 Pre-use functional test ... 44 12.9.1 Power on self test... 44 12.9.2 Reserve power check... 44 12.9.3 Patient circuit selection ... 45 12.9.4 Pre-functional test checks ... 45 12.9.5 Functional testing (Invasive dual limb) .. 45 12.9.6 Functional testing (Non invasive dual limb) ... 46 12.9.7 Functional testing (Non invasive single limb) ... 46 12.10 Turning the ventilator Off ... 47 12.10.1 Isolation from mains supply... 47
14. Ventilation - Invasive ... 66 14.1 CPAP... 66 14.2 CMV ... 68 14.3 PTV ... 70 14.4 PSV ... 72 14.5 SIMV... 74 14.6 HFOV ... 76 14.7 HFOV+CMV ... 78 14.8 Common warnings ... 80 14.9 Common cautions ... 80 14.9.1 Common alternate functions (Conventional ventilation) ... 80 14.9.1.1 Manual breath or Inspiratory hold... 80 14.9.1.2 O2 Boost or O2 suction... 80 14.9.2 Common alternate functions (High frequency ventilation) ... 80 14.9.2.1 Sigh or Sigh hold ... 80 14.9.2.2 O2 Boost or O2 suction... 80 14.10 Ventilation without a flow sensor ... 80
13. Patient circuit selection ... 50 13.1 Type of ventilation ... 50 13.1.1 Invasive ... 50 13.1.2 Non-Invasive (Dual limb)... 50 13.1.3 Non-Invasive (Single limb) ... 50 13.1.4 Non-Invasive O2 therapy (Single limb) . 50 13.1.4.1 Patient circuit selection ... 50 13.2 Assembly of BC6188 (Ø10 mm) or BC6198 (Ø15 mm) patient circuit... 50 13.2.1 Bacterial filters... 50 13.2.2 Humidification chamber... 51 13.2.3 Fitting the temperature probes to a BC6188 patient circuit ... 52 13.2.4 Fitting the temperature probes to a BC6198 patient circuit ... 52 13.2.5 Fitting the flow sensor to a BC6188 patient circuit... 53 13.2.6 Fitting the flow sensor to a BC6198 patient circuit... 53 13.2.7 Fitting the test lung... 53 13.3 Assembly of BC6188/DHW patient circuit 54 13.3.1 Bacterial filters... 54 13.3.2 Humidification chamber... 54 13.3.3 Fitting the test lung... 56 13.4 Modification of BC6188 or BC6188/DHW circuits for non-invasive dual limb ventilation. .. 57 13.4.1 Fitting a dual limb nCPAP generator. ... 57 13.5 Modification of BC6188 or BC6188/DHW circuits for non-invasive single limb ventilation. 58 13.5.1 Bacterial filters... 58 13.5.2 Humidification chamber... 58 13.5.3 Fitting the temperature probes ... 59 13.5.4 Fitting a single limb nCPAP generator... 60 13.6 Modification of BC6188 or BC6188/DHW circuits for non-invasive single limb O2 therapy.61 13.6.1 Bacterial filters... 61 13.6.2 Humidification chamber... 61 13.6.3 Fitting the temperature probes ... 62
15. Non-invasive - Dual limb ... 82 15.1 nCPAP D ... 82 15.2 NIPPV D ... 84 15.3 NIPPV Tr... 86 15.4 nHFOV ... 88
16. Non-invasive - Single limb ... 90 16.1 nCPAP S ... 90 16.2 DuoPAP... 92 16.3 O2 therapy... 94 16.4 Common warnings ... 96 16.5 Common cautions ... 96 16.6 Common note... 96
17. SpO2 and etCO2 monitoring ... 98 17.1 SpO2 monitoring (Masimo SET)... 98 17.1.1 Principle of Operation... 98 17.2 Masimo SET® Connection ... 99 17.2.1 Connection to ventilator... 99 17.2.2 Disconnection... 99 17.2.3 Selection of Masimo SET® Sensors... 99 17.2.4 Sensor application sites ... 99 17.2.5 Connection of a sensor ... 99 17.2.6 Disconnection... 99 17.3 Configuration ... 100 17.3.1 SpO2 monitoring ON/OFF ... 100 17.3.2 FastSat™ ... 100 17.3.3 Averaging Time... 100 17.3.4 Alarm Delay ... 100
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Contents 18.2.3 Deactivating OxyGenie®... 111 18.2.4 Activating manual override ... 112 18.2.5 Changing the SpO2 target range... 112 18.2.6 Averaging Time... 112 18.3 SpO2Waveform display option and OxyGenie® ... 112 18.4 OxyGenie® and O2 Boost... 113 18.5 OxyGenie® and O2 Suction ... 113
17.3.5 Auto O2: SpO2 Target range alarm limits. ... 100 17.3.6 SpO2 Sensitivity ... 100 17.3.7 Rapid Desat ... 101 17.3.8 Perf Index... 101 17.4 Monitored values... 101 17.5 SpO2 alarms thresholds ... 101 17.6 SpO2 Waveform and display options ... 101 17.7 Standard Waveform display option ... 102 17.7.0.1 SpO2 and etCO2 dual waveform display ... 102 17.8 SpO2Waveform display option ... 102 17.8.1 SpO2 Waveform in O2 therapy... 103 17.9 SpO2 module testing ... 103 17.10 Operation during mains power interruption (Mains power fail) ... 103 17.11 EtCO2 monitoring (MicroPod™) ... 104 17.11.1 Principle of Operation ... 104 17.11.2 Connection to ventilator... 104 17.11.3 Initialization Time ... 104 17.11.4 Disconnection ... 104 17.11.5 Mounting of module ... 104 17.11.6 Connection of a FilterLine™ ... 105 17.12 Configuration... 105 17.12.1 EtCO2 Monitoring ... 105 17.12.2 Pump control ... 105 17.12.3 Breath absence alarm time ... 105 17.12.4 Device information ... 105 17.13 Waveforms ... 106 17.13.0.1 EtCO2 and SpO2 dual waveform display ... 106 17.14 Monitored values... 106 17.15 EtCO2 alarms thresholds ... 106 17.16 Flow measurement compensation when using side stream etCO2 monitoring... 106 17.17 EtCO2module testing ... 106 17.18 Operational notes related to etCO2 monitoring using MicroPod™... 106 17.19 Operation during mains power interruption (Mains power fail) ... 107 17.20 Cleaning the MicroPod™ Enclosure ... 107
19. Operational features ... 116 19.1 General... 116 19.1.1 Standby Mode ... 116 19.1.2 Apnoea alarm set to “Off” ... 116 19.1.3 Reserve power source ... 116 19.1.4 Parameter Memory... 116 19.1.5 HFO variable I:E ratio (Only available with HFOV and nHFOV options)... 116 19.1.6 Pressure Support Breaths Not Delivered as Set ... 117 19.1.7 Trigger sensitivity... 117 19.1.8 Volume Targeted Ventilation, Vte (VTV) 117 19.1.8.1 Ti ... 117 19.1.8.2 Vte Target Resolution ... 117 19.1.9 Max Ti in PSV... 117 19.1.10 Suctioning (Closed suction)... 117 19.1.11 VTV & HFOV ... 117 19.1.11.1 Vte Target Resolution ... 117 19.2 Types of leak compensation ... 118 19.2.1 VTV and patient leak ... 118 19.2.2 NIV modes and patient leak ... 118 19.2.3 PSV mode automatic leak Compensation ... 118 19.3 O2 Suction... 118 19.4 O2 Boost ... 119 19.5 Alarm thresholds... 120 19.5.1 Alarm thresholds for conventional modes (invasive and non invasive - dual limb). ... 120 19.5.2 Alarm thresholds for Oscillatory modes (invasive and non invasive - dual limb). ... 121 19.5.2.1 HFOV & nHFOV ... 121 19.5.2.2 HFOV+CMV (invasive - dual limb) ... 122 19.5.3 Alarm thresholds for conventional modes (non invasive - single limb). ... 122 19.5.4 High pressure threshold alarm operation. ... 123 19.5.5 Low pressure threshold alarm operation123 19.6 Patient Circuits, Humidification and Nitric Oxide Therapy ... 124 19.6.1 Invasive ventilation & autofeed humidification chambers... 124 19.6.2 Non-Invasive ventilation & autofeed humidification chambers... 124
18. OxyGenie® ...110 18.1 Introduction ... 110 18.1.1 OxyGenie® modes of operation ... 110 18.1.1.1 Auto mode ... 110 18.1.1.2 Fallback mode:... 110 18.1.1.3 Manual override ... 111 18.1.1.4 Inactive mode... 111 18.2 OxyGenie® Fall back mode... 111 18.2.1 Checking the OxyGenie® response ... 111 18.2.2 Activating OxyGenie® ... 111
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Contents 20.2.6 Alarms tab - ventilatory mode... 142 20.2.6.1 Adjusting an alarm threshold ... 142 20.2.6.2 Alarm auto tracking/auto set thresholds... 142 20.2.7 History and Loudness... 143 20.2.8 Utilities tab - ventilatory mode ... 143 20.2.8.1 Flow sensor calibration... 143 20.2.8.2 O2 calibration ... 144 20.2.9 Brightness tab - ventilatory mode... 144 20.2.10 System tab - ventilatory mode... 144 20.2.11 Data tab - ventilatory mode ... 144 20.2.12 Layout... 144 20.2.13 Lock screen button ... 144 20.2.14 Pause/play... 144 20.2.15 Screen capture ... 144 20.2.16 Alarm bar ... 145 20.2.17 Mode specific controls... 145 20.2.17.1 Manual breath (Inspiratory Hold)... 145 20.2.17.2 Sigh (Sigh Hold) ... 145 20.2.18 Oscillation Pause... 145 20.2.19 HFO Activity... 145
19.6.3 Nitric Oxide Therapy ... 124 19.6.4 Nebulization of Medication ... 125 19.6.4.1 Nebulization using Aerogen® ... 125 19.7 Using the SLE6000 with SLE500E and SLE500S medical air compressors ... 125
20. User interface description ... 128 20.1 Standby mode ... 128 20.1.1 User interface... 128 20.1.2 Information panel ... 128 20.1.3 Information bar ... 128 20.1.4 Generic button/panel functions ... 128 20.1.4.1 Panel functions ... 128 20.1.4.2 Parameter time out... 128 20.1.4.3 Panel time out ... 128 20.1.4.4 Button states ... 128 20.1.4.5 Mode button ... 128 20.1.4.6 Start/Resume Ventilation button... 128 20.1.4.7 Alarms ... 128 20.1.4.8 Utilities button... 128 20.1.4.9 Calibration & Utilities button ... 129 20.1.4.10 Layout button ... 129 20.1.4.11 Multi function button ... 129 20.1.5 Mode button & Start/Resume Ventilation button ... 129 20.1.6 Alarm button ... 129 20.1.6.1 Limits tab ... 129 20.1.6.2 History tab ... 130 20.1.6.3 Loudness tab... 130 20.1.7 Utilities & Calibration & Utilities button .. 130 20.1.7.1 Sensors tab (without external sensor/s) ... 131 20.1.7.2 Sensors tab (with external sensor/s).. 131 20.1.7.3 Brightness tab ... 131 20.1.7.4 System Tab ... 132 20.1.7.5 Data tab... 133 20.1.7.6 Downloading screen captures... 134 20.1.8 Layout Tab... 135 20.1.8.1 Waveforms ... 136 20.1.8.2 Loops ... 136 20.1.9 Capturing, Retrieving & Deleting Loops.137 20.1.9.1 To capture Loops... 137 20.1.9.2 Trends ... 137 20.1.9.3 Single & double trend display... 138 20.1.9.4 Viewing trends... 138 20.2 Ventilation mode... 140 20.2.1 Alarm mute and pre-mute button... 140 20.2.2 Parameters... 140 20.2.2.1 Parameter types ... 140 20.2.2.2 Parameter states... 140 20.2.2.3 Modifying a parameter ... 140 20.2.2.4 Turning “ON” a parameter function ... 140 20.2.3 Preview mode ... 141 20.2.4 Patient circuit selection ... 141 20.2.5 Monitored values... 141 20.2.5.1 Single column/double column layout.. 141
21. Technical description ... 148 22. Description of ventilatory modes (Invasive) ... 149 22.1 CPAP... 149 22.2 CMV ... 149 22.2.1 CMV & VTV ... 149 22.3 PTV ... 149 22.3.1 PTV & VTV ... 149 22.4 PSV ... 149 22.4.1 PSV & VTV... 149 22.5 SIMV... 149 22.5.1 SIMV with P Support ... 150 22.5.2 SIMV & VTV ... 150 22.6 HFOV ... 150 22.6.1 HFO & VTV ... 150 22.7 HFOV+CMV ... 150
23. Description of ventilatory modes (Non-invasive) ... 150 23.1 nCPAP (Dual and Single limb)... 150 23.2 NIPPV (Dual limb) ... 150 23.3 NIPPV Tr. (Dual limb) ... 150 23.4 nHFOV (Dual limb only) ... 150 23.5 O2 Therapy (Single limb only) ... 150
24. Oxygen Calibration Routines ... 151 24.1 One Point O2 Calibration... 151 24.2 Two Point O2 Calibration ... 151
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Contents
25. N5402-REV2 & N5302 flow sensor ...152
26.5.8 BS EN ISO 80601-2-12 Disclosure ... 167 26.5.9 Measurement uncertainties ... 167 26.6 Patient circuits ... 167 26.7 Breathing system filters ... 167 26.7.1 N3029... 167 26.7.2 N3587... 168 26.7.3 N3588... 168 26.8 Maximum limited Pressures ... 168 26.9 Gas supplies ... 168 26.9.1 Oxygen supply ... 168 26.9.2 Air supply ... 168 26.9.2.1 Connectors ... 168 26.9.3 Flows ... 168 26.10 Service life... 168 26.11 Power, Dimensions, Classification... 168 26.11.1 Power AC... 168 26.11.2 Power DC ... 168 26.12 Operating Environment ... 169 26.12.1 Connectors ... 169 26.13 Classification (Electrical) ... 169 26.14 GMDN classification number ... 169 26.15 IP rating ... 169 26.16 Environmental Storage Conditions ... 169
25.1 Calibration of the Flow Sensor ... 152 25.2 Cleaning and high level disinfection of the N5402-REV2 Sensor... 153 25.2.1 Cleaning: ... 153 25.2.2 Disinfection:... 153 25.2.3 High level disinfection ... 153
26. Technical specification ...154 26.1 Operating Modes - Conventional Invasive Ventilation ... 154 26.1.1 CPAP mode... 154 26.1.2 CMV mode ... 154 26.1.3 PTV mode ... 155 26.1.4 PSV mode ... 155 26.1.5 SIMV mode ... 156 26.1.6 HFOV mode ... 157 26.1.7 HFOV+CMV mode ... 157 26.2 Operating Modes Conventional Non Invasive Ventilation ... 158 26.2.1 nCPAP D mode (Dual Limb)... 158 26.2.2 NIPPV D mode (Dual Limb) ... 158 26.2.3 NIPPV Tr. mode (Dual Limb)... 158 26.2.4 nHFOV mode (Dual Limb)... 159 26.2.5 nCPAP S mode (Single Limb) ... 159 26.2.6 DuoPAP mode (Single Limb)... 159 26.2.7 O2 therapy (Single Limb) ... 160 26.2.8 OxyGenie ... 160 26.2.8.1 OxyGenie PCLCS attributes ... 160 26.3 Mode of operation ... 160 26.4 Controls... 160 26.4.1 Power Button ... 160 26.4.2 User Interface... 160 26.4.2.1 Buttons ... 160 26.4.2.2 Tabs... 163 26.4.2.3 Controls ... 163 26.5 Measurement ... 165 26.5.1 Flow sensor... 165 26.5.2 Flow ... 165 26.5.3 Volume ... 165 26.5.4 Volume controlled breath accuracy ... 165 26.5.5 Pressure controlled breath accuracy (Invasive Ventilation) ... 165 26.5.6 Pressure controlled breath accuracy (Noninvasive Ventilation) ... 165 26.5.7 Measured parameters ... 165 26.5.7.1 Oxygen Concentration ... 166 26.5.7.2 Pressure ... 166 26.5.7.3 Trends ... 166 26.5.7.4 Sound pressure level ... 167 26.5.7.5 Exhalation Block Port Jet Sizes ... 167
27. Output ports (Electrical) ... 170 27.1 RS232 port ... 170 27.2 SLE6000 basic data output (V2.0). ... 170 27.2.1 SLE6000 basic data output specifications (V2.0)... 170 27.2.2 Communications Settings (V2.0) ... 170 27.2.2.1 Data Rate & Size (V2.0) ... 170 27.2.2.2 Data Format ... 170 27.2.3 Data Layout ... 170 27.2.4 Data Format ... 171 27.3 SLE6000 enhanced data output (V3.0) ... 176 27.3.1 SLE6000 enhanced data output specifications (V3.0) ... 176 27.3.2 Communications Settings (V3.0) ... 176 27.3.2.1 Data Rate & Size (V3.0) ... 176 27.3.2.2 Data Format ... 176 27.3.3 Data Layout ... 176 27.3.4 Data Format ... 177 27.4 Vuelink & Intellibridge EC10 ... 184 27.4.1 Connecting to the VueLink patient monitor ... 184 27.4.2 Connecting to the IntelliBridge EC10 module ... 184 27.4.3 Parameter Descriptions... 185 27.4.4 Alarm messages... 186 27.4.5 Waveform ... 188 27.4.6 VueLink Task Window Layout... 188 27.5 Nurse call ... 189
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Contents 27.5.1 Nurse call delay... 189 27.6 Ethernet... 189 27.7 USB (Data)... 189 27.8 USB (Power) ... 189 27.9 External Monitor ... 189
32.1 SpO2 Status messages ... 232 32.2 EtCO2 Status messages ... 233
33. Cleaning and disinfection ... 235 33.1 Instructions ... 235 33.2 External surface cleaning instructions... 235 33.3 External surface disinfection instructions . 236 33.4 Exhalation block cleaning instructions... 236 33.5 Exhalation block disinfection instructions . 236 33.6 Reusable Silencer disinfection instructions ... 236 33.7 Gas jet ports disinfection ... 236 33.8 Occlusion valve ... 236 33.9 Cleaning of main air intake filter. ... 236
28. Input ports (Electrical) ... 190 28.1 SpO2 and etCO2 ... 190 28.2 Flow sensor... 190 28.3 DC 24V... 190
29. Sensor Specifications ... 190 29.1 Masimo SET® ... 190 29.1.1 Functional SpO2 (%) ... 190 29.1.2 Pulse rate (BPM)... 190 29.1.3 Perfusion index (%)... 191 29.1.3.1 Senor Wavelength range ... 191 29.1.4 Accuracy notes... 191 29.1.5 Environmental ... 192 29.1.5.1 Operating Conditions ... 192 29.1.5.2 Storage Conditions... 192 29.1.5.3 Implied license statement... 192 29.2 MicroPod™ ... 192 29.2.1 Alarm limits... 193 29.2.2 Measurement formats ... 193 29.2.3 Calculation methods for Capnography.. 193 29.2.4 Environmental ... 193 29.2.4.1 Operating Conditions ... 193 29.2.4.2 Storage Conditions... 193 29.2.4.3 Trademarks ... 193
34. EMC compliance ... 237 34.1 Emissions test compliance levels... 237 34.2 Immunity tests compliance levels... 237 34.3 Warnings - EMC ... 238 34.4 Cautions - EMC ... 238
35. Pneumatic unit diagram ... 239 35.1 HFO capable pneumatic unit... 239 35.2 Conventional pneumatic unit ... 240 35.3 Patient circuit pneumatic diagrams ... 241
36. Software version identification .. 242 37. Troubleshooting Chart ... 244 37.1 Ventilation Related Problems ... 244 37.2 Ventilator Related Problems... 246 37.3 Sensor Related Problems ... 249
30. Alarms ... 194 30.1 Alarm Prioritization ... 194 30.1.1 Alarm Characteristics ... 194 30.1.2 Alarm sounder volume ... 194 30.1.3 Alarm log ... 194 30.2 Alarm Indicators characteristics ... 194 30.3 Alarm table ... 197 30.4 “Power supply fault” fault table... 219 30.5 “Ventilator out of calibration” fault table... 220 30.6 “Controller hardware fault” fault table... 221 30.7 “Monitor hardware fault” fault table ... 221
38. Planned preventative Maintenance (PPM) ... 252 38.1 PPM schedule ... 252 38.2 PPM kits ... 252 38.2.1 Kit A ... 252 38.2.2 Kit B... 252 38.3 Kit part numbers ... 252 38.4 Mains cable replacement ... 252 38.5 MicroPod™ PPM... 253
31. Sensor Alarms ...222
39. Ventilator Functional testing ... 253
31.1 Alarm Priorities ... 222 31.1.1 Status messages... 222 31.2 SpO2 monitoring (System alarms) ... 223 31.3 SpO2 monitoring (Patient alarms) ... 226 31.4 EtCO2 monitoring (System alarms)... 227 31.5 EtCO2 monitoring (Patient alarms)... 230
39.1 Alarm testing... 253 39.1.1 High Oxygen/Low Oxygen/Loss of gas supply alarm test... 253 39.1.2 Obstruction alarm - Blocked fresh gas .. 254 39.1.3 Partial occlusion alarm - Continuing positive pressure ... 254
32. Sensor Status messages ... 232
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Contents 39.1.4 High Pressure alarm - High pressure threshold exceeded... 254 39.1.5 Expired volume alarm - Tidal volume above/ below threshold ... 254 39.1.6 Volume alarm - Minute volume above/below threshold ... 254 39.1.7 Power supply failure alarm - Main power fail and battery check... 254 39.2 Performance testing. ... 255 39.2.1 Conventional ... 255 39.2.2 Oscillatory ... 255
43.4.1 File types ... 271 43.4.1.1 RealtimeLog ... 271 43.4.1.2 AlarmsLog ... 271 43.4.1.3 TrendsDataLog ... 272 43.4.1.4 SystemLog ... 272 43.4.1.5 DebugLog... 272 43.4.1.6 Log records ... 272 43.5 Log Viewer Features ... 273 43.5.1 Load Files... 273 43.5.2 Export to XML... 273 43.5.3 Export to Excel ... 273 43.5.3.1 Events Log / Trends Log ... 273 43.5.4 Search Filter ... 274 43.5.5 Load Trend data by day... 274 43.5.6 Trends Settings ... 274 43.5.6.1 Trends button ... 274 43.5.6.2 Trend Data button... 274 43.5.7 All Trends ... 274 43.5.8 Load Real-time Data ... 274 43.5.8.1 Wave Data... 274 43.5.8.2 Entire Waves ... 274 43.5.8.3 Waves... 274 43.5.9 “UTAS” option ... 275 43.5.10 Timeline ... 275 43.5.11 Display data from last day ... 275
40. External sensor functional testing ...256 40.1 Masimo SET®... 256 40.1.1 Masimo SET® Functional testing ... 256 40.1.2 Masimo SET® SpO2 and PR alarms ... 256 40.2 MicroPod™ ... 257 40.2.1 MicroPod™ Functional testing ... 257 40.2.2 MicroPod™ etCO2 alarm ... 257
41. Installation instructions ...260 41.0.1 Tools required for trolley assembly... 260 41.1 Unpacking. ... 260 41.2 Medicart assembly ... 261 41.2.1 Medicart kit contents ... 261 41.2.2 Assembly... 261 41.3 Ventilator unpacking... 262 41.4 Ventilator lifting points ... 263 41.5 Ventilator assembly to Medicart ... 263 41.6 Mains cable attachment ... 264 41.7 Pre-use functional test. ... 264 41.8 Ventilator configuration... 264
44. Training (User) ... 277 45. Training (service) ... 277 46. Consumables & Accessories ... 280 47. Glossary ... 285 48. SLE6000 markings and symbols 287 48.1 Description of ventilator markings ... 287 48.2 Description of option markings ... 288 48.3 Description of interface markings. ... 288 48.4 Description of Micropod™ markings. ... 290
42. User preferences ...266 42.1 Accessing user preferences ... 266 42.1.1 Parameters tab... 266 42.1.1.1 Parameters... 266 42.1.2 Ventilation tab... 267 42.1.3 Alarms tab ... 267 42.1.4 Interface tab ... 268 42.1.5 Regional tab ... 268 42.1.6 Save / Quit tab ... 268
43. SLE 6000 Event and Patient Log viewer software ...270 43.1 Minimum system requirements ... 270 43.1.1 Memory stick requirements ... 270 43.2 Installation of software ... 270 43.3 Downloading the Patient log or Event log 270 43.4 Export file formats ... 271
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Introduction
Introduction
13
Introduction
1. Introduction
1.1
The SLE6000 infant ventilator running version 2.0 software is modular in design. This release has 9 modules that fit into the core module.
Software modules (V2.0) 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.
The graphic below shows how all the modules when purchased interface with the core module.
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. Note: The software module requires the HFO pneumatic module to be installed. SLE6000 Single Limb NIV Software Module This software module adds the facility to ventilate using nCPAP and DuoPAP with a single limb circuit. 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
The software modules with an asterisk (*) require additional hardware.
This software module adds VTV to all of the conventional invasive monitoring modes.
For HFOV the ventilator requires the HFO module. (Factory fitted or service upgrade).
SLE6000 etCO2 Monitoring Software Module
For CO2 the user will have to purchase the etCO2 module and accessories.
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.
For SpO2 the user will have to purchase the SpO2 module and sensors. For CO2 and SpO2 modules and accessories see Section ’46. Consumables & Accessories’ on page 280.
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Introduction
2. Identifying software and hardware.
SLE6000 Masimo SpO2 Monitoring Software Module
To identify the software modules refer to the icon panel on the side of the ventilator.
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. SLE6000 OxyGenie® Software Module
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 IntelliBridge Software Module This software module adds the connectivity to the external monitoring systems provided by the Philips Vuelink and IntelliBridge modules.
For your ventilator the installed software modules will be shown in the ICON panel.
2.1
Pneumatic module identification for HFOV applicability
To confirm if you can install the HFOV module please refer to the ventilators serial number (Located on the rear of the ventilator). If the second digit of the number is zero (60104612345) then the HFOV software can be installed. If the second digit of the number is five (651048612345) then a pneumatic unit upgrade is required to allow the HFOV software module to activate. (Please contact SLE or your distributor for more information).
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Introduction
3. Description of the Ventilation Modes (Invasive)
Features with etCO2 module • etCO2 waveform when selected • High and low etCO2 alarm thresholds
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).
3.2 CMV Continuous Mandatory Ventilation
3.1 CPAP
In this mode the inspiratory cycle is initiated by the ventilator at a set RR rate. The breaths are time cycled.
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:• PEEP • PIP • RR (Respiratory rate)
User sets the following:-
• Ti (Inspiratory time)
• Ti (Inspiratory time)
• O 2%
• CPAP
Additional features
• PIP
• Rise time
• O 2%
Alarms thresholds
Additional features
• High and low PIP
• RR backup
• High and low PEEP
• Rise time
Alarms available when flow sensor connected
• Trigger Sensitivity (Flow or Pressure breath detection threshold)
• High and low Vte • High and low Vmin
Alarms
• Percentage leak
• High and low PIP • High and low CPAP
Additional items
• High RR
• Manual breath or Inspiratory hold button
• Apnoea time
(Can be turned OFF)
Features with VTV module • VTV of CMV breaths
Alarms available when flow sensor connected • High and low Vte • High and low Vmin • Percentage leak
Features with SpO2 module (Active when flow sensor connected)
• Pleth waveform when selected • High and low SpO2 alarm thresholds
Additional items
• High and low PR alarm thresholds
• Manual breath or Inspiratory hold button
OxyGenie® + SpO2 module
Features with SpO2 module
• SpO2 target range • High O2% alarm
• Pleth waveform when selected • High and low SpO2 alarm thresholds • High and low PR alarm thresholds
Features with etCO2 module
OxyGenie® + SpO2 module
• etCO2 waveform when selected
• SpO2 target range
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• High and low etCO2 alarm thresholds
• High O2% alarm
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Introduction
3.3 PTV
3.4 PSV
Patient Triggered Ventilation
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.
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. User sets the following:• RR (Respiratory rate) • Ti (Inspiratory time) • PEEP • PIP • O 2%
The termination sensitivity is also user adjustable from 0% - 50%.
Additional features
User sets the following:-
• Rise time
• RR (Respiratory rate)
• Trigger Sensitivity (Flow or Pressure breath detection threshold)
• Max Ti (Maximum Inspiratory time.)
Alarms thresholds
• PIP
• High and low PIP
• O 2%
• PEEP
• High and low PEEP
Additional features
• High RR • Apnoea time
• Rise time
(Can be turned OFF)
Alarms available when flow sensor connected
• Trigger Sensitivity (Flow or Pressure breath detection threshold)
• High and low Vte
• Termination Sensitivity
• High and low Vmin
Alarms thresholds
• Percentage leak
• High and low PIP
Additional items
• High and low PEEP
• Manual breath or Inspiratory hold button
• High RR • Apnoea time
Features with VTV module • VTV of patient breaths
(Can be turned OFF)
Alarms available when flow sensor connected
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• High and low Vte • High and low Vmin
Features with SpO2 module
• Percentage leak
• Pleth waveform when selected
Additional items
• High and low SpO2 alarm thresholds
• Manual breath or Inspiratory hold button
• High and low PR alarm thresholds
Features with VTV module
OxyGenie® + SpO2 module
• VTV of all breaths
• SpO2 target range
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Features with SpO2 module
• High O2% alarm
• Pleth waveform when selected
Features with etCO2 module
• High and low SpO2 alarm thresholds
• etCO2 waveform when selected
• High and low PR alarm thresholds
• High and low etCO2 alarm thresholds
OxyGenie® + SpO2 module • SpO2 target range • High O2% alarm
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Introduction Features with etCO2 module
Alarms thresholds
• etCO2 waveform when selected
• High and low PIP • High and low PEEP • High RR
• High and low etCO2 alarm thresholds
• Apnoea time
3.5 SIMV
(Can be turned OFF)
Alarms available when flow sensor connected
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.
• High and low Vte • High and low Vmin • Percentage leak Features with VTV module • VTV of all breaths
Time windows
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Features with SpO2 module • Pleth waveform when selected • High and low SpO2 alarm thresholds • High and low PR alarm thresholds OxyGenie® + SpO2 module
Assist windows
• SpO2 target range • High O2% alarm
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
Features with etCO2 module • etCO2 waveform when selected • High and low etCO2 alarm thresholds
Inspiratory time Time window =
60 RR
User sets the following:• • • • •
RR (Respiratory rate) Ti (Inspiratory time) PEEP PIP O 2%
Additional features • Rise time • Trigger Sensitivity (Flow or Pressure breath detection threshold) – The patient effort required for the ventilator to recognise the breath. • Pressure support
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Introduction
3.6 HFOV
3.7 HFOV+CMV
High Frequency Oscillation
A combination of oscillations during the expiratory or inspiratory & expiratory phase of a time cycled, pressure limited breath in CMV mode.
In this mode, the ventilator shall deliver continuous high frequency oscillation. There is no patient interaction.
User sets the following:-
User sets the following:-
• RR (Respiratory rate)
• Frequency
• Ti (Inspiratory time)
• I:E ratio
• Frequency
• MAP
• PEEP
• Delta P
• PIP
• VTV
• Delta P
• O 2%
• O 2%
Additional features
Additional features
• Sigh RR
• HFOV activity
• Sigh Ti
Features with SpO2 module
• Sigh P
• Pleth waveform when selected
Alarms thresholds
• High and low SpO2 alarm thresholds
• High and low Paw
• High and low PR alarm thresholds
Alarms available when flow sensor connected • High and low Vte
OxyGenie® + SpO2 module
• High and low Vmin
• SpO2 target range • High O2% alarm
• Percentage leak 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
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• High O2% alarm
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Introduction
4. Description of the Ventilation Modes (Non Invasive - Dual limb patient circuits)
Additional features • Rise time Alarms • High and low PIP
4.1 nCPAP
• High and low PEEP
Nasal Continuous Positive airway pressure.
Additional items • Manual breath or Inspiratory hold button
The ventilator generates a continuous positive airway pressure at a level set by the User.
Features with SpO2 module
User sets the following:-
• Pleth waveform when selected
• Ti (Inspiratory time)
• High and low SpO2 alarm thresholds
• CPAP
• High and low PR alarm thresholds
• PIP
OxyGenie® + SpO2 module
• O 2%
• SpO2 target range • High O2% alarm
Additional features • RR backup • Rise time • Trigger Sensitivity Pressure breath detection threshold – The patient effort required for the ventilator to recognise the breath. Alarms • 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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4.2 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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