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UM165-UK Issue 12 (SLE6000 User Manual)

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0% found this document useful (0 votes)
308 views292 pages

UM165-UK Issue 12 (SLE6000 User Manual)

Uploaded by

tkAcuN
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 292

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 All rights reserved. No part of this publication
Surrey CR2 6PL 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.
Telephone: +44 (0)20 8681 1414
OxyGenie® is a registered trade mark in the EEA.
Fax: +44 (0)20 8649 8570
E-mail: sales@sle.co.uk

Web site: www.sle.co.uk

Distributor

© Copyright SLE 02/07/2020


Document ref: UM165/UK Issue 12
UM165/UK

2
Fast index

This index allows users to move directly to the areas


Fast index
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

3
Fast index

This page is intentionally left blank.

4
Contents

Contents 8.2 Warnings - EMC ......................................... 27


8.3 Cautions - EMC .......................................... 27
1. Introduction .......................................... 14 8.4 Warnings - patient circuit & humidifier ........ 27
1.1 Software modules (V2.0)............................ 14 8.5 Warnings - nCPAP (single Limb) ................ 28
8.6 Warnings - clinical ...................................... 28
2. Identifying software and hardware. 8.6.1 Monitoring................................................ 28
.............................................................15 8.6.2 Clinical - invasive..................................... 28
2.1 Pneumatic module identification for HFOV 8.6.3 Clinical - non invasive.............................. 28
applicability....................................................... 15 8.7 Cautions - general ...................................... 28
8.7.1 Bacterial filters......................................... 29
3. Description of the Ventilation Modes 8.7.2 Flow sensor ............................................. 29
(Invasive) ............................................16 8.8 Cautions - clinical ....................................... 29
3.1 CPAP.......................................................... 16
9. Warnings & Cautions - External
3.2 CMV ........................................................... 16
sensors .............................................. 29
3.3 PTV ........................................................... 17
3.4 PSV ............................................................ 17 9.1 Warnings for Masimo SET® ............................. 29
3.5 SIMV ......................................................... 18 9.2 Cautions for Masimo SET® .............................. 30
3.6 HFOV ......................................................... 19 9.2.1 General.................................................... 30
3.7 HFOV+CMV .............................................. 19 9.2.2 Cleaning .................................................. 31
9.2.3 Cautions for alarms ................................. 31
4. Description of the Ventilation Modes 9.2.4 Cautions for measurements .................... 31
(Non Invasive - Dual limb patient 9.2.5 Cautions for Masimo sensors.................. 32
circuits) ..............................................20 9.3 Warnings for Oridion Micropod™ ............... 33
4.1 nCPAP........................................................ 20 9.4 Cautions for Oridion Micropod™ ................ 34
4.2 NIPPV ........................................................ 20
10. Warnings & Cautions - OxyGenie®
4.3 NIPPV Tr. ................................................... 21
............................................................. 35
4.4 nHFOV ....................................................... 21
10.1 Warnings for OxyGenie® .......................... 35
5. Description of the Ventilation Modes 10.2 Cautions for OxyGenie® ........................... 35
(Non Invasive - Single limb patient 10.3 Clinical warnings ...................................... 35
circuits) ..............................................22
11. Ventilator layout .......................... 38
5.1 nCPAP........................................................ 22
11.1 Front ......................................................... 38
5.2 DuoPAP...................................................... 22
11.2 Rear .......................................................... 39
6. Description of the Ventilation Modes
12. Ventilator basic setup ................. 42
(Non Invasive - O2
cannula) .............................................22 12.1 Pre-use Inspection ................................... 42
12.2 Connection of equipotential bonding cable42
6.1 O2 therapy ................................................. 22
12.3 Connection of mains power...................... 42
7. Intended use of the SLE6000 ......... 24 12.3.1 IEC/BS 1363/A3 specification power
leads................................................................. 42
7.1 Summary statement ................................... 24 12.3.2 Schuko and NEMA specification power
7.1.1 Medical indication.................................... 24 leads................................................................. 42
7.1.2 Medical contraindication.......................... 24 12.4 Connection of 24V DC auxiliary power..... 42
7.1.3 Patient type ............................................. 24 12.4.1 Mains or auxiliary power supply - power
7.1.4 Body part under treatment ...................... 24 switch status indicator ...................................... 43
7.1.5 Clinical therapy........................................ 24 12.5 Fitting the silencer and exhalation block .. 43
7.1.6 Main User Profile..................................... 24 12.6 Gas connections....................................... 43
7.2 Condition of use ......................................... 24 12.7 Ventilator - patient & operator position ..... 43
12.8 Turning the ventilator On .......................... 44
8. Warnings & Cautions - Ventilator 26 12.8.1 With mains connected ........................... 44
8.1 Warnings - general ..................................... 26 12.8.2 Without mains connected ...................... 44

5
Contents

12.8.3 With DC power connected .................... 44 13.6.4 Fitting a oxygen therapy nasal cannula. 63
12.9 Pre-use functional test ............................. 44
12.9.1 Power on self test.................................. 44 14. Ventilation - Invasive .................. 66
12.9.2 Reserve power check............................ 44 14.1 CPAP........................................................ 66
12.9.3 Patient circuit selection ......................... 45 14.2 CMV ......................................................... 68
12.9.4 Pre-functional test checks ..................... 45 14.3 PTV .......................................................... 70
12.9.5 Functional testing (Invasive dual limb) .. 45 14.4 PSV .......................................................... 72
12.9.6 Functional testing (Non invasive dual 14.5 SIMV......................................................... 74
limb) ................................................................. 46 14.6 HFOV ....................................................... 76
12.9.7 Functional testing (Non invasive single
14.7 HFOV+CMV ............................................. 78
limb) ................................................................. 46
14.8 Common warnings ................................... 80
12.10 Turning the ventilator Off ....................... 47
14.9 Common cautions .................................... 80
12.10.1 Isolation from mains supply................. 47
14.9.1 Common alternate functions (Conventional
13. Patient circuit selection .............. 50 ventilation) ........................................................ 80
14.9.1.1 Manual breath or Inspiratory hold....... 80
13.1 Type of ventilation .................................... 50 14.9.1.2 O2 Boost or O2 suction....................... 80
13.1.1 Invasive ................................................. 50 14.9.2 Common alternate functions (High frequency
13.1.2 Non-Invasive (Dual limb)....................... 50 ventilation) ........................................................ 80
13.1.3 Non-Invasive (Single limb) .................... 50 14.9.2.1 Sigh or Sigh hold ................................ 80
13.1.4 Non-Invasive O2 therapy (Single limb) . 50 14.9.2.2 O2 Boost or O2 suction....................... 80
13.1.4.1 Patient circuit selection ...................... 50 14.10 Ventilation without a flow sensor ............ 80
13.2 Assembly of BC6188 (Ø10 mm) or BC6198
(Ø15 mm) patient circuit................................... 50 15. Non-invasive - Dual limb ............ 82
13.2.1 Bacterial filters....................................... 50 15.1 nCPAP D .................................................. 82
13.2.2 Humidification chamber......................... 51 15.2 NIPPV D ................................................... 84
13.2.3 Fitting the temperature probes to a BC6188 15.3 NIPPV Tr................................................... 86
patient circuit .................................................... 52 15.4 nHFOV ..................................................... 88
13.2.4 Fitting the temperature probes to a BC6198
patient circuit .................................................... 52 16. Non-invasive - Single limb ......... 90
13.2.5 Fitting the flow sensor to a BC6188 patient 16.1 nCPAP S .................................................. 90
circuit................................................................ 53 16.2 DuoPAP.................................................... 92
13.2.6 Fitting the flow sensor to a BC6198 patient 16.3 O2 therapy................................................ 94
circuit................................................................ 53 16.4 Common warnings ................................... 96
13.2.7 Fitting the test lung................................ 53 16.5 Common cautions .................................... 96
13.3 Assembly of BC6188/DHW patient circuit 54 16.6 Common note........................................... 96
13.3.1 Bacterial filters....................................... 54
13.3.2 Humidification chamber......................... 54 17. SpO2 and etCO2 monitoring ....... 98
13.3.3 Fitting the test lung................................ 56 17.1 SpO2 monitoring (Masimo SET)............... 98
13.4 Modification of BC6188 or BC6188/DHW 17.1.1 Principle of Operation............................ 98
circuits for non-invasive dual limb ventilation. .. 57 17.2 Masimo SET® Connection ....................... 99
13.4.1 Fitting a dual limb nCPAP generator. .... 57 17.2.1 Connection to ventilator......................... 99
13.5 Modification of BC6188 or BC6188/DHW 17.2.2 Disconnection........................................ 99
circuits for non-invasive single limb ventilation. 58 17.2.3 Selection of Masimo SET® Sensors...... 99
13.5.1 Bacterial filters....................................... 58 17.2.4 Sensor application sites ........................ 99
13.5.2 Humidification chamber......................... 58 17.2.5 Connection of a sensor ......................... 99
13.5.3 Fitting the temperature probes .............. 59 17.2.6 Disconnection........................................ 99
13.5.4 Fitting a single limb nCPAP generator... 60 17.3 Configuration ............................................ 100
13.6 Modification of BC6188 or BC6188/DHW 17.3.1 SpO2 monitoring ON/OFF ..................... 100
circuits for non-invasive single limb O2 therapy.61 17.3.2 FastSat™ .............................................. 100
13.6.1 Bacterial filters....................................... 61 17.3.3 Averaging Time...................................... 100
13.6.2 Humidification chamber......................... 61 17.3.4 Alarm Delay ........................................... 100
13.6.3 Fitting the temperature probes .............. 62

6
Contents

17.3.5 Auto O2: SpO2 Target range alarm limits. 18.2.3 Deactivating OxyGenie®........................ 111
......................................................................... 100 18.2.4 Activating manual override .................... 112
17.3.6 SpO2 Sensitivity .................................... 100 18.2.5 Changing the SpO2 target range........... 112
17.3.7 Rapid Desat .......................................... 101 18.2.6 Averaging Time...................................... 112
17.3.8 Perf Index.............................................. 101 18.3 SpO2Waveform display option and OxyGenie®
......................................................................... 112
17.4 Monitored values...................................... 101
18.4 OxyGenie® and O2 Boost......................... 113
17.5 SpO2 alarms thresholds ........................... 101
18.5 OxyGenie® and O2 Suction ...................... 113
17.6 SpO2 Waveform and display options ....... 101
17.7 Standard Waveform display option .......... 102 19. Operational features ................... 116
17.7.0.1 SpO2 and etCO2 dual waveform display
......................................................................... 102 19.1 General..................................................... 116
17.8 SpO2Waveform display option ................. 102 19.1.1 Standby Mode ....................................... 116
17.8.1 SpO2 Waveform in O2 therapy.............. 103 19.1.2 Apnoea alarm set to “Off” ...................... 116
17.9 SpO2 module testing ................................ 103 19.1.3 Reserve power source .......................... 116
17.10 Operation during mains power interruption 19.1.4 Parameter Memory................................ 116
(Mains power fail) ............................................. 103 19.1.5 HFO variable I:E ratio (Only available with
17.11 EtCO2 monitoring (MicroPod™) ............. 104 HFOV and nHFOV options).............................. 116
17.11.1 Principle of Operation .......................... 104 19.1.6 Pressure Support Breaths Not Delivered as
17.11.2 Connection to ventilator....................... 104 Set .................................................................... 117
17.11.3 Initialization Time ................................. 104 19.1.7 Trigger sensitivity................................... 117
17.11.4 Disconnection ...................................... 104 19.1.8 Volume Targeted Ventilation, Vte (VTV) 117
17.11.5 Mounting of module ............................. 104 19.1.8.1 Ti ......................................................... 117
17.11.6 Connection of a FilterLine™ ................ 105 19.1.8.2 Vte Target Resolution ......................... 117
17.12 Configuration.......................................... 105 19.1.9 Max Ti in PSV........................................ 117
17.12.1 EtCO2 Monitoring ................................ 105 19.1.10 Suctioning (Closed suction)................. 117
17.12.2 Pump control ....................................... 105 19.1.11 VTV & HFOV ....................................... 117
19.1.11.1 Vte Target Resolution ....................... 117
17.12.3 Breath absence alarm time ................. 105
19.2 Types of leak compensation ..................... 118
17.12.4 Device information .............................. 105
19.2.1 VTV and patient leak ............................. 118
17.13 Waveforms ............................................. 106
17.13.0.1 EtCO2 and SpO2 dual waveform display 19.2.2 NIV modes and patient leak .................. 118
......................................................................... 106 19.2.3 PSV mode automatic leak Compensation
17.14 Monitored values.................................... 106 ......................................................................... 118
17.15 EtCO2 alarms thresholds ....................... 106 19.3 O2 Suction................................................ 118
17.16 Flow measurement compensation when using 19.4 O2 Boost .................................................. 119
side stream etCO2 monitoring.......................... 106 19.5 Alarm thresholds....................................... 120
17.17 EtCO2module testing ............................. 106 19.5.1 Alarm thresholds for conventional modes
17.18 Operational notes related to etCO2 monitoring (invasive and non invasive - dual limb). ........... 120
using MicroPod™............................................. 106 19.5.2 Alarm thresholds for Oscillatory modes
17.19 Operation during mains power interruption (invasive and non invasive - dual limb). ........... 121
(Mains power fail) ............................................. 107 19.5.2.1 HFOV & nHFOV ................................. 121
19.5.2.2 HFOV+CMV (invasive - dual limb) ..... 122
17.20 Cleaning the MicroPod™ Enclosure ...... 107
19.5.3 Alarm thresholds for conventional modes
18. OxyGenie® ...................................110 (non invasive - single limb). .............................. 122
19.5.4 High pressure threshold alarm
18.1 Introduction .............................................. 110 operation. ......................................................... 123
18.1.1 OxyGenie® modes of operation ............ 110 19.5.5 Low pressure threshold alarm operation123
18.1.1.1 Auto mode .......................................... 110
19.6 Patient Circuits, Humidification and Nitric Oxide
18.1.1.2 Fallback mode:................................... 110
18.1.1.3 Manual override ................................. 111 Therapy ............................................................ 124
18.1.1.4 Inactive mode..................................... 111 19.6.1 Invasive ventilation & autofeed humidification
18.2 OxyGenie® Fall back mode...................... 111 chambers.......................................................... 124
18.2.1 Checking the OxyGenie® response ...... 111 19.6.2 Non-Invasive ventilation & autofeed
18.2.2 Activating OxyGenie® ............................ 111 humidification chambers................................... 124

7
Contents

19.6.3 Nitric Oxide Therapy ............................. 124 20.2.6 Alarms tab - ventilatory mode................ 142
19.6.4 Nebulization of Medication ................... 125 20.2.6.1 Adjusting an alarm threshold .............. 142
19.6.4.1 Nebulization using Aerogen® ............ 125 20.2.6.2 Alarm auto tracking/auto set
19.7 Using the SLE6000 with SLE500E and thresholds......................................................... 142
SLE500S medical air compressors .................. 125 20.2.7 History and Loudness............................ 143
20.2.8 Utilities tab - ventilatory mode ............... 143
20. User interface description .......... 128 20.2.8.1 Flow sensor calibration....................... 143
20.2.8.2 O2 calibration ..................................... 144
20.1 Standby mode .......................................... 128
20.2.9 Brightness tab - ventilatory mode.......... 144
20.1.1 User interface........................................ 128
20.2.10 System tab - ventilatory mode............. 144
20.1.2 Information panel .................................. 128
20.2.11 Data tab - ventilatory mode ................. 144
20.1.3 Information bar ...................................... 128
20.2.12 Layout.................................................. 144
20.1.4 Generic button/panel functions ............. 128
20.2.13 Lock screen button .............................. 144
20.1.4.1 Panel functions ................................... 128
20.1.4.2 Parameter time out............................. 128 20.2.14 Pause/play........................................... 144
20.1.4.3 Panel time out .................................... 128 20.2.15 Screen capture .................................... 144
20.1.4.4 Button states ...................................... 128 20.2.16 Alarm bar ............................................. 145
20.1.4.5 Mode button ....................................... 128 20.2.17 Mode specific controls......................... 145
20.1.4.6 Start/Resume Ventilation button......... 128 20.2.17.1 Manual breath (Inspiratory Hold)...... 145
20.1.4.7 Alarms ................................................ 128 20.2.17.2 Sigh (Sigh Hold) ............................... 145
20.1.4.8 Utilities button..................................... 128 20.2.18 Oscillation Pause................................. 145
20.1.4.9 Calibration & Utilities button ............... 129
20.2.19 HFO Activity......................................... 145
20.1.4.10 Layout button ................................... 129
20.1.4.11 Multi function button ......................... 129
21. Technical description ................. 148
20.1.5 Mode button & Start/Resume Ventilation
button .............................................................. 129 22. Description of ventilatory modes
20.1.6 Alarm button ......................................... 129 (Invasive) ........................................... 149
20.1.6.1 Limits tab ........................................... 129
20.1.6.2 History tab ......................................... 130 22.1 CPAP........................................................ 149
20.1.6.3 Loudness tab...................................... 130 22.2 CMV ......................................................... 149
20.1.7 Utilities & Calibration & Utilities button .. 130 22.2.1 CMV & VTV ........................................... 149
20.1.7.1 Sensors tab (without external 22.3 PTV .......................................................... 149
sensor/s) .......................................................... 131 22.3.1 PTV & VTV ........................................... 149
20.1.7.2 Sensors tab (with external sensor/s).. 131 22.4 PSV .......................................................... 149
20.1.7.3 Brightness tab .................................... 131
22.4.1 PSV & VTV............................................ 149
20.1.7.4 System Tab ........................................ 132
20.1.7.5 Data tab.............................................. 133 22.5 SIMV......................................................... 149
20.1.7.6 Downloading screen captures............ 134 22.5.1 SIMV with P Support ............................. 150
20.1.8 Layout Tab............................................. 135 22.5.2 SIMV & VTV .......................................... 150
20.1.8.1 Waveforms ......................................... 136 22.6 HFOV ....................................................... 150
20.1.8.2 Loops ................................................. 136 22.6.1 HFO & VTV ........................................... 150
20.1.9 Capturing, Retrieving & Deleting Loops.137 22.7 HFOV+CMV ............................................. 150
20.1.9.1 To capture Loops................................ 137
20.1.9.2 Trends ................................................ 137 23. Description of ventilatory modes
20.1.9.3 Single & double trend display............. 138 (Non-invasive) ................................... 150
20.1.9.4 Viewing trends.................................... 138
20.2 Ventilation mode....................................... 140 23.1 nCPAP (Dual and Single limb).................. 150
20.2.1 Alarm mute and pre-mute button........... 140 23.2 NIPPV (Dual limb) .................................... 150
20.2.2 Parameters............................................ 140 23.3 NIPPV Tr. (Dual limb) ............................... 150
20.2.2.1 Parameter types ................................ 140 23.4 nHFOV (Dual limb only) ........................... 150
20.2.2.2 Parameter states................................ 140 23.5 O2 Therapy (Single limb only) .................. 150
20.2.2.3 Modifying a parameter ....................... 140
20.2.2.4 Turning “ON” a parameter function .... 140 24. Oxygen Calibration Routines ..... 151
20.2.3 Preview mode ....................................... 141 24.1 One Point O2 Calibration.......................... 151
20.2.4 Patient circuit selection ......................... 141 24.2 Two Point O2 Calibration .......................... 151
20.2.5 Monitored values................................... 141
20.2.5.1 Single column/double column layout.. 141

8
Contents

25. N5402-REV2 & N5302 flow sensor 26.5.8 BS EN ISO 80601-2-12 Disclosure ....... 167
.............................................................152 26.5.9 Measurement uncertainties ................... 167
25.1 Calibration of the Flow Sensor ................. 152 26.6 Patient circuits .......................................... 167
25.2 Cleaning and high level disinfection of the 26.7 Breathing system filters ........................... 167
N5402-REV2 Sensor........................................ 153 26.7.1 N3029.................................................... 167
25.2.1 Cleaning: ............................................... 153 26.7.2 N3587.................................................... 168
25.2.2 Disinfection:........................................... 153 26.7.3 N3588.................................................... 168
25.2.3 High level disinfection ........................... 153 26.8 Maximum limited Pressures ..................... 168
26.9 Gas supplies ............................................ 168
26. Technical specification ...............154 26.9.1 Oxygen supply ...................................... 168
26.1 Operating Modes - Conventional Invasive 26.9.2 Air supply .............................................. 168
26.9.2.1 Connectors ........................................ 168
Ventilation ........................................................ 154
26.9.3 Flows .................................................... 168
26.1.1 CPAP mode........................................... 154
26.10 Service life.............................................. 168
26.1.2 CMV mode ............................................ 154
26.11 Power, Dimensions, Classification.......... 168
26.1.3 PTV mode ............................................. 155
26.11.1 Power AC............................................. 168
26.1.4 PSV mode ............................................. 155
26.11.2 Power DC ............................................ 168
26.1.5 SIMV mode ........................................... 156
26.12 Operating Environment .......................... 169
26.1.6 HFOV mode ......................................... 157
26.12.1 Connectors ......................................... 169
26.1.7 HFOV+CMV mode ................................ 157
26.13 Classification (Electrical) ........................ 169
26.2 Operating Modes Conventional Non Invasive
26.14 GMDN classification number .................. 169
Ventilation ........................................................ 158
26.15 IP rating .................................................. 169
26.2.1 nCPAP D mode (Dual Limb).................. 158
26.16 Environmental Storage Conditions ......... 169
26.2.2 NIPPV D mode (Dual Limb) .................. 158
26.2.3 NIPPV Tr. mode (Dual Limb)................. 158 27. Output ports (Electrical) ............. 170
26.2.4 nHFOV mode (Dual Limb)..................... 159
27.1 RS232 port ............................................... 170
26.2.5 nCPAP S mode (Single Limb) ............... 159
27.2 SLE6000 basic data output (V2.0). .......... 170
26.2.6 DuoPAP mode (Single Limb)................ 159
27.2.1 SLE6000 basic data output specifications
26.2.7 O2 therapy (Single Limb) ...................... 160
(V2.0)................................................................ 170
26.2.8 OxyGenie .............................................. 160
26.2.8.1 OxyGenie PCLCS attributes .............. 160 27.2.2 Communications Settings (V2.0) ........... 170
27.2.2.1 Data Rate & Size (V2.0) ..................... 170
26.3 Mode of operation .................................... 160
27.2.2.2 Data Format ....................................... 170
26.4 Controls.................................................... 160
27.2.3 Data Layout ........................................... 170
26.4.1 Power Button ........................................ 160
27.2.4 Data Format .......................................... 171
26.4.2 User Interface........................................ 160
27.3 SLE6000 enhanced data output (V3.0) .... 176
26.4.2.1 Buttons .............................................. 160
26.4.2.2 Tabs.................................................... 163 27.3.1 SLE6000 enhanced data output
26.4.2.3 Controls ............................................. 163 specifications (V3.0) ......................................... 176
26.5 Measurement .......................................... 165 27.3.2 Communications Settings (V3.0) ........... 176
26.5.1 Flow sensor........................................... 165 27.3.2.1 Data Rate & Size (V3.0) ..................... 176
27.3.2.2 Data Format ....................................... 176
26.5.2 Flow ...................................................... 165
27.3.3 Data Layout ........................................... 176
26.5.3 Volume .................................................. 165
27.3.4 Data Format .......................................... 177
26.5.4 Volume controlled breath accuracy ....... 165
27.4 Vuelink & Intellibridge EC10 ..................... 184
26.5.5 Pressure controlled breath accuracy
27.4.1 Connecting to the VueLink patient monitor
(Invasive Ventilation) ........................................ 165
......................................................................... 184
26.5.6 Pressure controlled breath accuracy (Non-
27.4.2 Connecting to the IntelliBridge EC10 module
invasive Ventilation) ......................................... 165
......................................................................... 184
26.5.7 Measured parameters ........................... 165
26.5.7.1 Oxygen Concentration ...................... 166 27.4.3 Parameter Descriptions......................... 185
26.5.7.2 Pressure ............................................ 166 27.4.4 Alarm messages.................................... 186
26.5.7.3 Trends ................................................ 166 27.4.5 Waveform .............................................. 188
26.5.7.4 Sound pressure level ......................... 167 27.4.6 VueLink Task Window Layout................ 188
26.5.7.5 Exhalation Block Port Jet Sizes ........ 167 27.5 Nurse call ................................................. 189

9
Contents

27.5.1 Nurse call delay..................................... 189 32.1 SpO2 Status messages ............................ 232
27.6 Ethernet.................................................... 189 32.2 EtCO2 Status messages .......................... 233
27.7 USB (Data)............................................... 189
27.8 USB (Power) ............................................ 189 33. Cleaning and disinfection .......... 235
27.9 External Monitor ....................................... 189 33.1 Instructions ............................................... 235
33.2 External surface cleaning instructions...... 235
28. Input ports (Electrical) ................ 190 33.3 External surface disinfection instructions . 236
28.1 SpO2 and etCO2 ...................................... 190 33.4 Exhalation block cleaning instructions...... 236
28.2 Flow sensor.............................................. 190 33.5 Exhalation block disinfection instructions . 236
28.3 DC 24V..................................................... 190 33.6 Reusable Silencer disinfection
instructions ....................................................... 236
29. Sensor Specifications ................. 190 33.7 Gas jet ports disinfection .......................... 236
29.1 Masimo SET® .......................................... 190 33.8 Occlusion valve ........................................ 236
29.1.1 Functional SpO2 (%) ............................. 190 33.9 Cleaning of main air intake filter. .............. 236
29.1.2 Pulse rate (BPM)................................... 190
29.1.3 Perfusion index (%)............................... 191
34. EMC compliance ......................... 237
29.1.3.1 Senor Wavelength range ................... 191 34.1 Emissions test compliance levels............. 237
29.1.4 Accuracy notes...................................... 191 34.2 Immunity tests compliance levels............. 237
29.1.5 Environmental ....................................... 192 34.3 Warnings - EMC ....................................... 238
29.1.5.1 Operating Conditions ......................... 192 34.4 Cautions - EMC ........................................ 238
29.1.5.2 Storage Conditions............................. 192
29.1.5.3 Implied license statement................... 192 35. Pneumatic unit diagram ............. 239
29.2 MicroPod™ .............................................. 192
35.1 HFO capable pneumatic unit.................... 239
29.2.1 Alarm limits............................................ 193
35.2 Conventional pneumatic unit .................... 240
29.2.2 Measurement formats ........................... 193
35.3 Patient circuit pneumatic diagrams .......... 241
29.2.3 Calculation methods for Capnography.. 193
29.2.4 Environmental ....................................... 193 36. Software version identification .. 242
29.2.4.1 Operating Conditions ......................... 193
29.2.4.2 Storage Conditions............................. 193 37. Troubleshooting Chart ............... 244
29.2.4.3 Trademarks ........................................ 193
37.1 Ventilation Related Problems ................... 244
30. Alarms .......................................... 194 37.2 Ventilator Related Problems..................... 246
37.3 Sensor Related Problems ........................ 249
30.1 Alarm Prioritization ................................... 194
30.1.1 Alarm Characteristics ............................ 194 38. Planned preventative Maintenance
30.1.2 Alarm sounder volume .......................... 194 (PPM) .................................................. 252
30.1.3 Alarm log ............................................... 194
38.1 PPM schedule .......................................... 252
30.2 Alarm Indicators characteristics ............... 194
38.2 PPM kits ................................................... 252
30.3 Alarm table .............................................. 197
38.2.1 Kit A ....................................................... 252
30.4 “Power supply fault” fault table................. 219
38.2.2 Kit B....................................................... 252
30.5 “Ventilator out of calibration” fault table.... 220
38.3 Kit part numbers ....................................... 252
30.6 “Controller hardware fault” fault table....... 221
38.4 Mains cable replacement ......................... 252
30.7 “Monitor hardware fault” fault table .......... 221
38.5 MicroPod™ PPM...................................... 253
31. Sensor Alarms .............................222
39. Ventilator Functional testing ..... 253
31.1 Alarm Priorities ......................................... 222
39.1 Alarm testing............................................. 253
31.1.1 Status messages................................... 222
39.1.1 High Oxygen/Low Oxygen/Loss of gas supply
31.2 SpO2 monitoring (System alarms) ........... 223
alarm test.......................................................... 253
31.3 SpO2 monitoring (Patient alarms) ............ 226
39.1.2 Obstruction alarm - Blocked fresh gas .. 254
31.4 EtCO2 monitoring (System alarms).......... 227
39.1.3 Partial occlusion alarm - Continuing positive
31.5 EtCO2 monitoring (Patient alarms)........... 230
pressure ........................................................... 254
32. Sensor Status messages ............ 232

10
Contents

39.1.4 High Pressure alarm - High pressure 43.4.1 File types ............................................... 271
threshold exceeded.......................................... 254 43.4.1.1 RealtimeLog ....................................... 271
39.1.5 Expired volume alarm - Tidal volume above/ 43.4.1.2 AlarmsLog .......................................... 271
below threshold ................................................ 254 43.4.1.3 TrendsDataLog ................................... 272
39.1.6 Volume alarm - Minute volume above/below 43.4.1.4 SystemLog ......................................... 272
43.4.1.5 DebugLog........................................... 272
threshold .......................................................... 254
43.4.1.6 Log records ........................................ 272
39.1.7 Power supply failure alarm - Main power fail
43.5 Log Viewer Features ................................ 273
and battery check............................................. 254
43.5.1 Load Files.............................................. 273
39.2 Performance testing. ................................ 255
43.5.2 Export to XML........................................ 273
39.2.1 Conventional ......................................... 255
43.5.3 Export to Excel ...................................... 273
39.2.2 Oscillatory ............................................. 255 43.5.3.1 Events Log / Trends Log .................... 273
43.5.4 Search Filter .......................................... 274
40. External sensor functional testing
43.5.5 Load Trend data by day......................... 274
.............................................................256
43.5.6 Trends Settings ..................................... 274
40.1 Masimo SET®........................................... 256 43.5.6.1 Trends button ..................................... 274
40.1.1 Masimo SET® Functional testing .......... 256 43.5.6.2 Trend Data button............................... 274
40.1.2 Masimo SET® SpO2 and PR alarms ..... 256 43.5.7 All Trends .............................................. 274
40.2 MicroPod™ .............................................. 257 43.5.8 Load Real-time Data ............................. 274
40.2.1 MicroPod™ Functional testing .............. 257 43.5.8.1 Wave Data.......................................... 274
40.2.2 MicroPod™ etCO2 alarm ...................... 257 43.5.8.2 Entire Waves ...................................... 274
43.5.8.3 Waves................................................. 274
41. Installation instructions ..............260 43.5.9 “UTAS” option ........................................ 275
41.0.1 Tools required for trolley assembly........ 260 43.5.10 Timeline ............................................... 275
41.1 Unpacking. ............................................... 260 43.5.11 Display data from last day ................... 275
41.2 Medicart assembly ................................... 261
44. Training (User) ............................ 277
41.2.1 Medicart kit contents ............................. 261
41.2.2 Assembly............................................... 261 45. Training (service) ........................ 277
41.3 Ventilator unpacking................................. 262
41.4 Ventilator lifting points .............................. 263 46. Consumables & Accessories ..... 280
41.5 Ventilator assembly to Medicart ............... 263
41.6 Mains cable attachment ........................... 264
47. Glossary ............................................... 285
41.7 Pre-use functional test. ............................ 264 48. SLE6000 markings and symbols 287
41.8 Ventilator configuration............................. 264
48.1 Description of ventilator markings ............ 287
42. User preferences .........................266 48.2 Description of option markings ................. 288
48.3 Description of interface markings. ............ 288
42.1 Accessing user preferences ..................... 266
48.4 Description of Micropod™ markings. ....... 290
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

11
Contents

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12
Introduction

Introduction

13
Introduction

1. Introduction 1.1 Software modules (V2.0)


The SLE6000 infant ventilator running version 2.0 Core Configuration Software Module
software is modular in design. This release has 9
modules that fit into the core module. Core software is installed on all SLE6000
ventilators and includes invasive modes
The graphic below shows how all the modules when (CPAP,CMV, PTV,
purchased interface with the core module. PSV, SIMV) and non-invasive modes (nCPAP,
NIPPV) as standard.
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
For HFOV the ventilator requires the HFO module. conventional invasive monitoring modes.
(Factory fitted or service upgrade).
SLE6000 etCO2 Monitoring Software
For CO2 the user will have to purchase the etCO2 Module
module and accessories.

For SpO2 the user will have to purchase the SpO2 This software module adds etCO2 software that
module and sensors. allows an Oridion MicroPod™ to interface with the
SLE6000. It requires an Oridion MicroPod™ and
For CO2 and SpO2 modules and accessories see neonatal sampling lines.
Section ’46. Consumables & Accessories’ on page
280.

14
Introduction

SLE6000 Masimo SpO2 Monitoring 2. Identifying software and


Software Module
hardware.
To identify the software modules refer to the icon
This software module adds SpO2 software that panel on the side of the ventilator.
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).

15
Introduction

3. Description of the Ventilation Features with etCO2 module


Modes (Invasive) • etCO2 waveform when selected
The ventilator has the ability to be used as either a • High and low etCO2 alarm thresholds
pressure controlled, volume targeted ventilator, as a
pressure limited, time cycled ventilator, and as a
high frequency oscillation ventilator (Only available 3.2 CMV
with HFOV option).
Continuous Mandatory Ventilation
3.1 CPAP In this mode the inspiratory cycle is
Continuous Positive Airway Pressure initiated by the ventilator at a set RR rate. The
breaths are time cycled.
The ventilator generates a continuous
positive airway pressure at a level set by the User. User sets the following:-
The apnoea alarm will sound if the patient has not • PEEP
made any breath attempts within the set apnoea • PIP
period.
• 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
Alarms available when flow sensor connected • VTV of CMV breaths +
• High and low Vte
• High and low Vmin Features with SpO2 module
• Percentage leak (Active when flow sensor • Pleth waveform when selected
connected)
• 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
• Pleth waveform when selected
• SpO2 target range +
• High O2% alarm
• High and low SpO2 alarm thresholds
• High and low PR alarm thresholds Features with etCO2 module
• etCO2 waveform when selected
OxyGenie® + SpO2 module
• SpO2 target range + • High and low etCO2 alarm thresholds

• High O2% alarm

16
Introduction

3.3 PTV 3.4 PSV


Patient Triggered Ventilation Pressure Supported Ventilation
This is a pressure limited mode of
In this mode all the patient's breath
ventilation in which each breath is patient
attempts are pressure supported. Mechanical
triggered and supported. The breath is patient
breaths are delivered at the set parameters (Ti,
triggered, pressure supported and patient
PEEP and PIP) if no patient effort is recognised.
terminated. The infant therefore has control of the
User sets the following:- whole cycle, i.e. the inspiratory time and frequency.
This form of ventilation is dependant on the use of a
• RR (Respiratory rate)
flow sensor placed between the ET tube connector
• Ti (Inspiratory time) and the patient circuit. Changes in flow or volume
• PEEP signal detects spontaneous breathing.
• PIP
The termination sensitivity is also user adjustable
• O 2% from 0% - 50%.
Additional features User sets the following:-
• Rise time • RR (Respiratory rate)
• Trigger Sensitivity (Flow or Pressure breath • Max Ti (Maximum Inspiratory time.)
detection threshold) • PEEP
Alarms thresholds • PIP
• High and low PIP • O 2%
• High and low PEEP
Additional features
• High RR
• Rise time
• Apnoea time (Can be turned OFF)
• Trigger Sensitivity (Flow or Pressure breath
Alarms available when flow sensor connected 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 (Can be turned OFF)
Features with VTV module Alarms available when flow sensor connected
• VTV of patient breaths + • 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 + 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

17
Introduction

Features with etCO2 module Alarms thresholds


• etCO2 waveform when selected • High and low PIP
• High and low etCO2 alarm thresholds • High and low PEEP
• High RR
• Apnoea time (Can be turned OFF)
3.5 SIMV
Alarms available when flow sensor connected
Synchronised Intermittent Mandatory • High and low Vte
Ventilation
• High and low Vmin
The frequency of mandatory breaths is
determined by the RR control. When a mandatory • Percentage leak
breath is due an assist window opens and waits for
a patient's inspiratory effort. When this occurs the
Features with VTV module
ventilator delivers a synchronised breath (SIMV
breaths). Once the breath has been delivered the
assist window closes until the next set breath is due.
+
• VTV of all breaths
Time windows Features with SpO2 module
• Pleth waveform when selected
• High and low SpO2 alarm thresholds
• High and low PR alarm thresholds

Assist windows OxyGenie® + SpO2 module

If the ventilator does not see a patient's attempt to • SpO2 target range +
breathe before the end of the defined time window • High O2% alarm
then a mandatory breath is delivered. The
Features with etCO2 module
mandatory breath point is the Time Window minus
the Inspiratory Time. • etCO2 waveform when selected
Mandatory breath point • High and low etCO2 alarm thresholds

Inspiratory time
60
Time window =
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

18
Introduction

3.6 HFOV 3.7 HFOV+CMV


High Frequency Oscillation A combination of oscillations during the
expiratory or inspiratory & expiratory
In this mode, the ventilator shall deliver
phase of a time cycled, pressure limited
continuous high frequency oscillation. There is no
breath in CMV mode.
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
• Sigh P Features with SpO2 module
• 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 +
• Percentage leak • High O2% alarm
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

19
Introduction

4. Description of the Ventilation Additional features


Modes (Non Invasive - Dual • Rise time

limb patient circuits) Alarms


• High and low PIP
4.1 nCPAP • High and low PEEP
Nasal Continuous Positive airway Additional items
pressure.
• 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
• O 2% OxyGenie® + SpO2 module

Additional features
• SpO2 target range +
• High O2% alarm
• 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

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%

20
Introduction

4.3 NIPPV Tr. 4.4 nHFOV


Non invasive positive pressure Nasal high frequency oscillation
ventilation Triggered
In this mode, the ventilator shall deliver
In this mode all the patient's breath attempts are continuous high frequency oscillation. There is no
pressure supported. Mechanical breaths are patient interaction.
delivered at the set parameters (Ti, PEEP and PIP)
if no patient effort is recognized. User sets the following:-
• Frequency
User sets the following:-
• I:E ratio
• RR (Respiratory rate)
• MAP
• Ti (Inspiratory time)
• Delta P
• PEEP
• O 2%
• PIP
• O 2% Additional features
• Sigh RR
Additional features
• Sigh Ti
• Rise time
• Sigh P
• Trigger Sensitivity Pressure breath detection
threshold Alarms thresholds
• High and low Paw
Alarms
• High and low PIP Additional items
• High and low PEEP • Sigh button or Sigh Hold
Additional items
• Manual breath or Inspiratory hold button 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 +
OxyGenie® + SpO2 module • High O2% alarm
• SpO2 target range +
• High O2% alarm

21
Introduction

5. Description of the Ventilation 5.2 DuoPAP


Modes (Non Invasive - Single Non invasive positive pressure
ventilation.
limb patient circuits)
In this mode the inspiratory cycle is initiated by the
5.1 nCPAP ventilator at a set respiratory rate. The breaths are
Nasal Continuous Positive airway time cycled.
pressure. User sets the following:-
The ventilator generates a continuous positive • RR (Respiratory rate)
airway pressure at a level set by the User. • Ti (Inspiratory time)
• PEEP
User sets the following:-
• PIP
• Ti (Inspiratory time)
• O 2%
• CPAP
• PIP Additional items
• O 2% • Manual breath or Inspiratory hold button

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 • High and low PR alarm thresholds
threshold – The patient effort
required for the ventilator to OxyGenie® + SpO2 module
recognise the breath. • SpO2 target range +
Alarms • High O2% alarm
• High and low PIP
• High and low CPAP
• High RR 6. Description of the Ventilation
• Apnoea time (Can be turned OFF) Modes (Non Invasive - O2
Additional items
cannula)
• Manual breath or Inspiratory hold button
6.1 O2 therapy
The ventilator generates a continuous
Features with SpO2 module flow at a level set by the User.
• Pleth waveform when selected
• High and low SpO2 alarm thresholds The User sets the following:-
• High and low PR alarm thresholds • Flow
OxyGenie® + SpO2 module • O 2%

• SpO2 target range + Features with SpO2 module


• High O2% alarm • Pleth waveform when selected
• High and low SpO2 alarm thresholds

OxyGenie® + SpO2 module


• SpO2 target range +
• High O2% alarm

22
Intended use

Intended use
“Summary statement” on page 24
“Condition of use” on page 24

23
Intended use

7. Intended use of the SLE6000 7.1.5 Clinical therapy


The SLE 6000 is used in conventional or High
7.1 Summary statement Frequency Oscillation modes of ventilation for:
The SLE6000 ventilator is intended to provide
continuous or intermittent respiratory support for • Non-life support ventilation
premature neonates greater than 0.3kg, term • Life support ventilation (needs Vte or etCO2
neonates and infants, as well as paediatric patients measurement)
up to 30kg depending on condition. • Non-invasive and invasive ventilation

The ventilator is intended for use in either invasive 7.1.6 Main User Profile
or non-invasive applications. The available The SLE 6000 is intended to be used in clinical
ventilator modes and features are configurable to application only by appropriately trained medical
customer requirements such as High Frequency personnel and operated only by trained technicians
Oscillation, etCO2 monitoring and SpO2 monitoring during maintenance and service.
(measuring and monitoring blood oxygen saturation
level using the SLE SpO2 cable) and OxyGenie® a 7.2 Condition of use
function that automatically adjusts the delivered O2 The SLE6000 ventilator is intended to provide
to increase time spent in the SpO2 target range). continuous or intermittent respiratory support for
premature and term neonates, infants, and
The SLE6000 ventilator is intended for use by a paediatric patients depending on condition.
physician or authorised qualified medical personnel. The ventilator is mobile when trolley mounted but
intended for static operation in a hospital intensive
The ventilator is mobile when trolley mounted but care unit in normal use.
intended for static operation in a Professional The ventilator is intended for use within an
Healthcare Facility. See section ’8. Warnings & appropriate medically clean environment, with
medical grade Air and Oxygen and with appropriate
Cautions - Ventilator’ on page 26 for exclusions.
MEDICALLY CLEAN ventilator breathing system
7.1.1 Medical indication and accessories.
Any pathology, where optimal gas exchange is
compromised and/or where patient condition
necessitates respiratory support.

7.1.2 Medical contraindication


There are no known contra-indications to
ventilation.
Cautions and warnings in this manual should be
adhered to.
Use of OxyGenie® is contraindicated on patients
whose target SpO2 is outside the following target
ranges.
90-94%
91-95%
92-96%
94-98%

7.1.3 Patient type


The SLE6000 series ventilator is intended to be
used on neonatal through paediatric patients with
weight ranging from 0.3 to 30 kg and dependent on
lung condition.

7.1.4 Body part under treatment


The ventilator is designed to administer ventilation
to the patient’s respiratory system.

24
Warnings and cautions

Warnings and cautions


“Warnings & Cautions - Ventilator” on page 26
“Warnings & Cautions - External sensors” on page 29

25
Warnings and cautions

8. Warnings & Cautions - 14 The VGA port shall not be used when connected
to a patient. It is for training purposes only.
Ventilator
15 The ventilator does not use Latex, nor was it
8.1 Warnings - general used in its construction.
The following warnings must be read and 16 Disconnect the mains power supply from the
understood before using the ventilator. Failure to do ventilator prior to cleaning.
so could lead to injury or death of the patient.
17 Do not cover the ventilator during use or allow
1 The whole of this manual should be read and the ventilator to become covered by any fabric or
understood before using the ventilator. curtain. Do not allow the exhaust ports or inlet
Operators must be suitably trained and clinically vents to become obstructed or blocked by
authorized for using the ventilator with patients. positioning the ventilator near curtains or fabric.
Particular care should be taken to check the
ventilator pressures prior to changing modes. 18 The ventilator has no emergency air intake.

2 Oxygen - Clinical use. Oxygen is a drug and 19 In a “Mains Power Fail” condition and if the user
should be prescribed as such. clears the “Mains Power Fail” alarm, the next
power related alarm that will trigger will be the
3 Oxygen - Fire Hazard. Oxygen vigorously medium priority “Battery Low” alarm. This
supports combustion and its use requires special indicates that the internal power supply has
precaution to avoid fire hazards. Keep all reached 25% capacity. If the user clears the
sources of ignition away when oxygen is in use. medium priority “Mains Power Fail” alarm, the
Do not use oil or grease on oxygen fittings or next power related alarm that will trigger will be
where oxygen is used. the high priority “Battery Low” alarm. This
4 Check the condition of the gas supply hoses to indicates that the internal power supply has a
the ventilator. Do not use any hose that shows less than 10 minutes remaining battery life.The
signs of cracking, abrasion, kinking, splits, user shall remove the patient to an alternative
excessive wear or ageing. Make sure that the Air form of ventilation at this point if mains power
or O2 hose has not come into contact with oil or cannot be restored.
grease. 20 Do not allow the batteries to remain in a deep
5 When the ventilator is being used on a patient, a discharged state. Recharge the batteries as
suitably trained person must be in attendance at soon as possible to preserve battery life. If the
all times to take prompt action should an alarm ventilator is to be placed in storage then ensure
or other indication of a problem occur. the batteries are fully charged.

6 Do not enter the “Standby” mode when 21 When the ventilator is used without the flow
connected to a patient. No ventilation is sensor and ventilating a patient with a 3mm or
delivered. smaller size endotracheal tubes, in the case of
patient extubation or the ET tube disconnecting
7 In case of ventilator failure, the lack of immediate from its ET connector, only the monitoring of
access to appropriate alternative means of flow, or of SpO2, or of transcutaneous Oxygen
ventilation can result in patient death. and Carbon Dioxide will dependably alert the
8 Do not touch the patient and ventilator metalwork medical team to an alarm situation, not the
at the same time to avoid earthing the patient. monitoring of pressures.
22 Failure to comply with the recommended service
9 The ventilator shall not be used in a hyperbaric
programs could lead to injury of the patient,
chamber.
operator or damage to the ventilator. It is the
10 The ventilator shall not be used in a MRI owners responsibility to ensure that the
(Magnetic Resonance Imaging) scanner. equipment is regularly maintained.
11 The ventilator shall not be used with helium or 23 To avoid the risk of electric shock, this equipment
mixtures with helium. must only be connected to a supply mains with
protective earth.
12 The ventilator accuracy can be affected by the
gas added by use of a nebuliser. 24 The ventilator must not be started or used on
battery power alone.
13 Any computer connected to the ventilator must
be specified for medical use.

26
Warnings and cautions

25 If the ventilator is adversely affected by 2 Use of accessories, transducers and cables


equipment emitting electromagnetic interference other than those specified or provided by the
then that equipment should be switched off or manufacturer of this equipment could result in
removed from the vicinity. Conversely, if the increased electromagnetic emissions or
ventilator is the source of interference to other decreased electromagnetic immunity of this
neighbouring equipment, it should be switched equipment and result in improper operation.
off or taken to another location.
3 Portable RF communications equipment
26 The functioning of this machine may be (including peripherals such as antenna cables
adversely affected by the operation of equipment and external antennas) should be used no closer
such as high frequency surgical (diathermy) than 30 cm (12 inches) to any part of the
equipment, defibrillators, mobile phones or short- SLE6000, including cables specified by the
wave therapy equipment in the vicinity. manufacturer. Otherwise, degradation of the
performance of this equipment could result.
27 The equipment is not suitable for use with, or in
the presence of flammable anaesthetic mixtures. 8.3 Cautions - EMC
28 Do not clean the touchscreen whilst the Only use the cables listed in chapter ’47.
ventilator is in operation. Consumables & Accessories’ on page 254 for
connection to accessories or transducers.
29 No modification of the ventilator is allowed. Any
modification of the ventilator or system requires
evaluation to BS EN 60601-1. (Please contact 8.4 Warnings - patient circuit &
SLE if you require modification of the ventilator humidifier
or the system). 4 Use only SLE approved patient circuits. The
30 The ventilator shall only be used with SLE accuracy of controlled and measured
approved accessories. parameters is only guaranteed by use of the
approved circuits.
31 The RS232 port shall not be connected to an IT
network. 5 On no account should antistatic or electrically
conductive tubing be used.
32 USB data devices shall not be connected to the
data port during patient use. 6 The humidifier used in the patient circuit must be
operated and maintained in accordance with the
33 Only the Aerogen USB controller shall be manufacturer’s instructions.
connected to the rear mounted USB port marked
Aerogen USB controller. 7 Any water trap used in the patient circuit must be
held in the upright positions below the patient
34 Ensure that the ventilator is not positioned in and drained regularly before it is full.
such a way that it is difficult to operate the
disconnection device. 8 The patient circuit should not be modified other
than the way described for non invasive use.
35 When the air or oxygen supplies are known to Modified patient circuits or circuits with additional
contain moisture and the ventilator is to be used sections or components may produce too high a
continuously the user is required to check the circuit resistance and circuit compliance for
rear mounted water traps at regular intervals. effective ventilation.
36 The user needs to be aware that SLE6000 9 Do not allow the heated section of the patient
ventilator alarms can be configured to user circuit to come into contact with the patient.
defined presets. This can lead to units within a
single locale having different alarm presets. 10 Adding attachments or other components or sub-
assemblies to the ventilator breathing system
can change the pressure gradient across the
ventilator breathing system and that such
8.2 Warnings - EMC
changes to the ventilator breathing system can
1 Use of this equipment adjacent to or stacked adversely affect the ventilator performance.
with other equipment should be avoided
because it could result in improper operation. If 11 Nebulisation or humidification can increase the
such use is necessary, this equipment and the resistance of breathing system filters and that
other equipment should be observed to verify the operator needs to monitor the breathing
that they are operating normally. system filter frequently for increased resistance
and blockage.

27
Warnings and cautions

12 Do not allow heated section of the patient circuit ventilator settings and inspired oxygen
to become covered, i.e. by a blanket or covering. concentrations may be required.
13 Do not touch the humidifier hot plate if exposed, 2 All ventilation should only be initiated by fully
as it may burn the skin when hot. trained and experienced medical personnel.
14 Ensure the temperature probes are cleaned and 3 Incorrect humidification; could cause
sterilized as per the manufacturers instructions. mobilisation of secretions and airway blockage.

8.5 Warnings - nCPAP (single Limb) 4 Intra-ventricular haemorrhage, cerebral


ischaemia due to increased levels of carbon
1 When using Small or Extra Small nasal prongs
dioxide.
during CPAP, the Ventilator may not raise an
alarm if a patient disconnection occurs. It is 5 Volutrauma resulting in (bronchopulmonary
recommended that back-up breaths are always dysplasia in the newborn);
turned on as this will deliver back up breaths and
alert the user to a low PIP condition if the nasal 6 The use of an uncuffed ET tube causing leaks
prongs become detached. Only the monitoring of preventing oxygenation and ventilation.
SpO2, or of transcutaneous Oxygen and Carbon 7 Maintenance of an adequate airway is of
Dioxide will dependably alert the medical team to paramount importance.
a patient disconnection.
8.6.3 Clinical - non invasive
8.6 Warnings - clinical
1 Damage to nares.
1 Failure to take corrective action when the alarms
are activated could result in injury or death to the 2 Under- or over- ventilatory support (with
patient. consequent abnormalities in blood gases);
3 Incorrect humidification; could cause
2 Use of the nurse call function does not remove
mobilisation of secretions and airway blockage.
the need to monitor both the patient or ventilator
at regular intervals. 4 Damage to trachea and bronchi;

8.6.1 Monitoring 5 Over- or under- inflation of the lung;


The minimum bedside patient monitoring 6 Atalectasis;
requirements are:
7 Air leak syndrome (pneumothorax,
• ECG/heart rate. pneumomediastinum, pneumopericardium.
• Blood pressure. pulmonary interstitial emphysema).
• Respiratory rate. 8.7 Cautions - general
• Oxygen saturation. 1 During use apart from the flow sensor there are
If the bedside patient monitor cannot provide blood no serviceable ventilator items.
pressure and oxygen saturation monitoring then
2 The ventilator should be disposed of in
independent blood pressure and oxygen saturation
accordance to the local WEEE (Waste Electrical
monitoring shall be used.
and Electronic Equipment) guidelines.
Additional monitoring HFOV and non invasive
3 Do not use solvent based cleaning solutions to
ventilation
clean the touchscreen or covers.
• Transcutaneous carbon dioxide monitoring. 4 Do not use a sharp instrument, such as a pen to
Additional monitoring conventional invasive activate the controls as the excessive pressure
modes applied by the point will damage the touchscreen
membrane.
• Transcutaneous carbon dioxide monitoring or
etCO2 monitoring 5 The ventilator contains temperature dependant
For units that are without Transcutaneous carbon devices which perform normally in controlled
dioxide monitoring or etCO2 monitoring facilities for environments in hospitals. However if the
ventilator has been stored at a temperature
arterial / venous or capillary blood sampling must be
different to that in which it will be used, allow the
available.
unit to acclimatize before powering up.
8.6.2 Clinical - invasive (Operating temperature range +10ºC to +40ºC)
1 When switching from conventional to high- 6 Disposal of the Oxygen cell should be in
frequency ventilation, or vice-versa, alterations in accordance with local regulations for hazardous

28
Warnings and cautions

substances. Do not incinerate. SLE offers a cell 9. Warnings & Cautions -


disposal service.
External sensors
7 Care should be taken when attaching other
equipment as this may affect mechanical 9.1 Warnings for Masimo SET®
stability.
8 When using the SLE6000 in conjunction with
either the SLE500E or SLE500S medical air 1Explosion hazard. Do not use the pulse
compressors the user needs to be aware that the oximeter in the presence of flammable
HFOV performance is limited. The SLE500E or anesthetics or other flammable substance in
SLE500S medical air compressors maximum combination with air, oxygen-enriched
flow is 60 l/min the SLE6000 requires 85 l/min. environments, or nitrous oxide.
This disparity will only be evident in HFOV mode 2 A pulse oximeter should NOT be used as an
where Delta P pressures of greater than 150 apnoea monitor.
mbar will cause the MAP (mean airway
pressure) to be unstable. 3 Do not start or operate the pulse oximeter unless
the setup was verified to be correct.
8.7.1 Bacterial filters
4 Do not use the pulse oximeter if it appears or is
1 The use of bacterial filters between the fresh gas
suspected to be damaged.
port and humidifier supply line & exhalation block
and the expiratory supply line is recommended. 5 To ensure safety, avoid stacking multiple devices
or placing anything on the device during
8.7.2 Flow sensor operation.
1 The reusable and single use flow sensor are
serviceable items and may require cleaning 6 Pulse rate measurement is based on the optical
during use. detection of a peripheral flow pulse and therefore
may not detect certain arrhythmias. The pulse
8.8 Cautions - clinical oximeter should not be used as a replacement or
1 Avoid setting the alarm limits to their extreme substitute for ECG based arrhythmia analysis.
values as this can limit the ventilators ability to 7 A pulse oximeter should be considered an early
detect hazardous conditions. warning device. As a trend towards patient
deoxygenation is indicated, blood samples
should be analyzed by a laboratory co-oximeter
to completely understand the patient’s condition.
8 If an alarm condition (other than exceptions
listed herein) occurs while the alarm silence
period is set to off, the only alarm indications will
be visual displays and symbols related to the
alarm condition.
9 To protect from electric shock, always remove
the sensor and completely disconnect the pulse
oximeter before bathing the patient.
10 Measure the oximeter’s leakage current
whenever an external device is connected to the
serial port. Leakage current must not exceed 100
microamperes.
11 Do not place the pulse oximeter or accessories
in any position that might cause it to fall on the
patient.

12 Do not use extension cords or adaptors of any


type. The power cord and plug must be intact
and undamaged.
13 If there is any doubt about the integrity of the
protective earth conductor arrangement, operate
the oximeter on internal battery power until the

29
Warnings and cautions

AC power supply protective conductor is fully 9.2 Cautions for Masimo SET®
functional.
9.2.1 General
14 To ensure patient electrical isolation, connect
1 Do not place the pulse oximeter where the
only to other equipment with electronically
controls can be changed by the patient.
isolated circuits.
2 When patients are undergoing photodynamic
15 As with all medical equipment, carefully route
therapy they may be sensitive to light sources.
patient cabling to reduce the possibility of patient
Pulse oximetry may be used only under careful
entanglement or strangulation.
clinical supervision for short time periods to
16 Interfering Substances: Carboxyhemoglobin may minimize interference with photodynamic
erroneously increase readings. The level of therapy.
increase is approximately equal to the amount of
3 Do not place the pulse oximeter on electrical
carboxyhemoglobin present. Dyes, or any
equipment that may affect the device, preventing
substance containing dyes, that change usual
it from working properly.
arterial pigmentation may cause erroneous
readings. 4 Change the application site or replace the sensor
and/or patient cable when a “Replace sensor”
17 Do not use the pulse oximeter or Masimo
and/or “Replace patient cable”, or a persistent
oximetry sensors during magnetic resonance
poor signal quality message (such as “Low SIQ”)
imaging (MRI) scanning. Induced current could
is displayed on the host monitor. These
potentially cause burns. The pulse oximeter may
messages may indicate that patient monitoring
affect the MRI image, and the MRI unit may
time is exhausted on the patient cable or sensor.
affect the accuracy of the oximetry
measurements. 5 If using pulse oximetry during full body
irradiation, keep the sensor out of the radiation
18 RS-232 System Interconnection. Consult IEC-
field. If the sensor is exposed to the radiation, the
601-1-1 for system interconnection guidance.
reading might be inaccurate or the device might
The specific requirements for system
read zero for the duration of the active irradiation
interconnection are dependent upon the device
period.
connected to the pulse oximeter and the relative
locations of each device from the patient, and 6 Electrical Shock Hazard: Carry out periodic tests
the relative location of the connected device to to verify that leakage currents of patient-applied
the medically used room containing the pulse circuits and the system are within acceptable
oximeter. In all circumstance the pulse oximeter limits as specified by the applicable safety
must be connected to a grounded AC power standards. The summation of leakage currents
supply. The pulse oximeter is referred to as an must be checked and in compliance with IEC
IEC 601/F device in the summary of situations 60601-1 and UL60601-1. The system leakage
table contained in IEC 601-1-1. current must be checked when connecting
external equipment to the system. When an
event such as a component drop of
approximately 1 meter or greater or a spillage of
blood or other liquids occurs, retest before
further use. Injury to personnel could occur.
7 Disposal of product - Comply with local laws in
the disposal of the device and/or its accessories.
8 To minimize radio interference, other electrical
equipment that emits radio frequency
transmissions should not be in close proximity to
the pulse oximeter.
9 Do not loop the patient cabling into a tight coil or
wrap around the device, as this can damage the
patient cabling.

30
Warnings and cautions

10 Additional information specific to the Masimo 9.2.4 Cautions for measurements


sensors compatible with the pulse oximeter, Variation in measurements may be profound and
including information about parameter/ may be affected by sampling technique as well as
measurement performance during motion and the patient's physiological conditions. Any results
low perfusion, may be found in the sensor's exhibiting inconsistency with the patient’s clinical
directions for use (DFU). status should be repeated and/or supplemented
with additional test data. Blood samples should be
11 Cables and sensors are provided with X-Cal™
analyzed by laboratory instruments prior to clinical
technology to minimize the risk of inaccurate
decision making to completely understand the
readings and unanticipated loss of patient
patient’s condition.
monitoring. Refer to the Cable or Sensor DFU for
the specified duration of the patient monitoring
The pulse oximeter should not be used as the sole
time.
basis for medical decisions. It must be used in
12 Do not adjust, repair, open, disassemble, or conjunction with clinical signs and symptoms.
modify the pulse oximeter or accessories. Injury
to personnel or equipment damage could occur. If the accuracy of any measurement does not seem
reasonable, first check the patient’s vital signs by
9.2.2 Cleaning alternate means and then check the pulse oximeter
1 Use cleaning solutions only as instructed in this for proper functioning.
operator's manual.
Inaccurate measurements may be caused by:
2 Electrical shock and flammability hazard: Before
cleaning, always turn off the device and
1 Incorrect sensor application or use
disconnect from any power source.
2 Significant levels of dysfunctional hemoglobins.
3 Do not submerge the pulse oximeter in any (e.g., carboxyhemoglobin or methemoglobin)
cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide 3 Intravascular dyes such as indocyanine green or
or any other method. This will seriously damage methylene blue.
the pulse oximeter.
4 Interfering Substances: Dyes, Nail polish or any
4 Do not soak or immerse the monitor in any liquid. substance containing dyes, that change usual
blood pigmentation may cause erroneous
5 Use the cleaning solution sparingly. Excessive readings.
solution can flow into the monitor and cause
damage to internal components. 5 Pulse rate measurement is based on the optical
detection of a peripheral flow pulse and therefore
6 Do not attempt to clean the device while may not detect certain arrhythmias. The pulse
monitoring a patient. oximeter should not be used as a replacement or
7 Do not touch, press, or rub the display panels substitute for ECG based arrhythmia analysis.
with abrasive cleaning compounds, instruments, 6 Exposure to excessive illumination, such as
brushes, rough surface materials, or bring them surgical lamps (especially ones with a xenon
into contact with anything that could scratch the light source),
panel.
7 Bilirubin lamps, fluorescent lights, infrared
8 Do not use petroleum-based or acetone heating lamps, or direct sunlight (exposure to
solutions, or other harsh solvents, to clean the excessive illumination can be corrected by
oximeter. These substances attack the device’s covering the sensor with a dark or opaque
materials and device failure can result. material)
9.2.3 Cautions for alarms 8 Excessive patient movement.
1 Check alarm limits each time the pulse oximeter
9 SpO2 is empirically calibrated to functional
is used to ensure that they are appropriate for
the patient being monitored. arterial oxygen saturation in healthy adult
volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin
(MetHb). A pulse oximeter cannot measure
elevated levels of COHb or MetHb. Increases in
either COHb or MetHb will affect the accuracy of
the SpO2 measurement.

31
Warnings and cautions

For increased COHb: COHb levels above normal 23 Placement of a sensor on an extremity with a
tend to increase the level of SpO2. The level of blood pressure cuff, arterial catheter, or
increase is approximately equal to the amount of intravascular line.
COHb that is present.
24 If SpO2 values indicate hypoxemia, a laboratory
blood sample should be taken to confirm the
NOTE: High levels of COHb may occur with a
patient’s condition.
seemingly normal SpO2. When elevated levels
of COHb are suspected, laboratory analysis 25 A functional tester cannot be used to assess the
(CO-Oximetry) of a blood sample should be accuracy of the pulse oximeter.
performed.
26 High-intensity extreme lights (such as pulsating
10 For increased MetHb: the SpO2 may be strobe lights) directed on the sensor, may not
decreased by levels of MetHb of up to allow the pulse oximeter to obtain vital sign
approximately 10% to 15%. At higher levels of readings.
MetHb, the SpO2 may tend to read in the low to
27 When using the Maximum Sensitivity setting,
mid 80s. When elevated levels of MetHb are performance of the "Sensor Off" detection may
suspected, laboratory analysis (CO-Oximetry) of be compromised. If the device is in this setting
a blood sample should be performed. and the sensor becomes dislodged from the
11 Venous congestion may cause under reading of patient, the potential for false readings may
actual arterial oxygen saturation. Therefore, occur due to environmental "noise" such as light,
assure proper venous outflow from monitored vibration, and excessive air movement.
site. Sensor should not be below heart level (e.g. 28 Loss of pulse signal can occur in any of the
sensor on hand of a patient in a bed with arm following situation:
dangling to the floor).
12 Venous pulsations may cause erroneous low The sensor is too tight.
readings (e.g. tricuspid value regurgitation). There is excessive illumination from light
sources such as a surgical lamp, a bilirubin
13 Patient suffers from abnormal pulse rhythm. lamp, or sunlight.
A blood pressure cuff is inflated on the same
14 The pulsations from intra-aortic balloon support
extremity as the one with a SpO2 sensor
can be additive to the pulse rate on the oximeter
pulse rate display. Verify patient's pulse rate attached.
against the ECG heart rate. The patient has hypotension, severe
vasoconstriction, severe anemia, or
15 Use only Masimo approved accessories. hypothermia.
There is arterial occlusion proximal to the sensor.
16 Motion artifact may lead to inaccurate
The patient is in cardiac arrest or is in shock.
measurements.
29 The pulse oximeter may be used during
17 Elevated levels of Total Bilirubin may lead to
electrocautery, but this may affect the accuracy
inaccurate SpO2 measurements.
or availability of the parameters and
18 With very low perfusion at the monitored site, the measurements.
readings may read lower than core arterial 30 Sensors applied too tightly or that become tight
oxygen saturation. due to edema will cause inaccurate readings and
19 If the Low Perfusion message is frequently can cause pressure necrosis.
displayed, find a better perfused monitoring site.
In the interim, assess the patient and, if 9.2.5 Cautions for Masimo sensors
indicated, verify oxygenation status through 1 Before use, carefully read the sensor directions
other means. for use.

20 Do not expose the Pulse CO-Oximeter to 2 Use only Masimo oximetry sensors for SpO2
excessive moisture such as direct exposure to measurements. Other oxygen transducers
rain. (sensors) may cause improper MS board
performance.
21 Excessive moisture can cause the Pulse CO-
Oximeter to perform inaccurately or fail.
22 Do not immerse the sensor or patient cable in
water or, solvents, or cleaning solutions (The
sensors and connectors are not waterproof).

32
Warnings and cautions

3 Tissue damage can be caused by incorrect 9.3 Warnings for Oridion


application or use (for example by wrapping the Micropod™
sensor too tightly). Inspect the sensor site as
directed in the sensor Directions for Use to
ensure skin integrity and correct positioning and
1 If uncertain about the accuracy of any
adhesion of the sensor.
measurement, first check the patient’s vital signs
4 Do not use damaged sensors. Do not use any by alternate means, and then make sure the
sensor with exposed optical components. module is functioning correctly.

5 Do not immerse the sensor in water, solvents, or 2 The module should not be used as an apnoea
cleaning solutions (the sensors and connectors monitor.
are not waterproof). Do not sterilize by
3 To ensure patient safety, do not place the
irradiation, steam, or ethylene oxide. See the
module in any position that might cause it to fall
cleaning instructions in the directions for use for
on the patient.
reusable Masimo sensors.
4 Carefully route the FilterLine™ to reduce the
6 Do not use damaged patient cables. Do not
possibility of patient entanglement or
immerse the patient cables in water, solvents, or
strangulation.
cleaning solutions (the patient cable connectors
are not waterproof). Do not sterilize by 5 Check CO2 and O2 tubing regularly during use to
irradiation, steam, or ethylene oxide. See the ensure that no kinks are present. Kinked tubing
cleaning instructions in the directions for use for may cause inaccurate CO2 sampling or affect O2
reusable Masimo patient cables. delivery to patient.
6 Do not lift the module by the FilterLine™, as the
FilterLine™ could disconnect from the module,
causing the module to fall on the patient.
7 Do not pull the module so that it becomes
detached from the patient monitor. After
readjusting the position of the module for any
reason, ensure that it has not become detached
from the monitor.
8 To ensure accurate performance and prevent
device failure, do not expose the module to
extreme moisture, such as rain.
9 The use of accessories and cables other than
those specified may result in increased emission
and/or decreased immunity of the equipment
and/or system.
10 CO2 readings and respiratory rate can be
affected by certain ambient environmental
conditions, and certain patient conditions.
11 The module is a prescription device and is to be
operated by qualified healthcare personnel only.
12 If calibration does not take place as instructed,
the module may be out of calibration. A module
that is out of calibration may provide inaccurate
results.
13 Do not use the FilterLine™ H Set Infant/Neonatal
during magnetic resonance imaging (MRI)
scanning. Using the FilterLine™ H Set Infant/
Neonatal during MRI scanning could create an
artefact on the MRI image.
14 Do not silence the audible alarm on the monitor if
patient safety may be compromised.

33
Warnings and cautions

15 Always respond immediately to a system alarm 28 Do not cut or remove any part of the sample line.
since the patient may not be monitored during Cutting the sample line could lead to erroneous
certain alarm conditions. readings.
16 Before each use, verify that the alarm limits are 29 Do not use compressed air to clean the
appropriate for the patient being monitored. FilterLine™.

17 When using the MicroPod™with anesthetics, 30 If too much moisture enters the sampling line
nitrous oxide or high concentrations of oxygen, (i.e., from patient secretions), the message
connect the gas outlet to a scavenger system. Clearing FilterLine™ will appear in the message
area. If the sampling line cannot be cleared, the
18 The MicroPod™ is not suitable for use in the message FilterLine™ Blockage will appear in the
presence of flammable anesthetic mixture with message area. Replace the sampling line once
air, oxygen or nitrous oxide. the FilterLine™ Blockage message appears.
19 The FilterLine™ may ignite in the presence of O2 9.4 Cautions for Oridion Micropod™
when directly exposed to laser, ESU devices, or
1 If the MicroPod™ sustains structural damage so
high heat. When performing head and neck
that its internal components are visible, it should
procedures involving laser, electrosurgical
not be used.
devices or high heat, use with caution to prevent
flammability of the FilterLine™ or surrounding 2 An extension cable should not be used with the
surgical drapes. USB version or either RS-232 version of the
MicroPod™.
20 To protect against electric shock hazard, the
3 Caution: Exercise care when removing the
module cover is to be removed only by qualified
MicroPod™ from a mount so that your finger
service personnel. There are no user-
does not get caught in the clip during removal.
serviceable parts inside.
4 During MRI scanning, the module must be
21 To ensure patient electrical isolation, connect placed outside the MRI suite. When the module
only to other equipment with circuits that are is used outside the MRI suite, etCO2 monitoring
electrically isolated. can be implemented using the FilterLine™ XL.
22 Operating high frequency electrosurgical 5 In high-altitude environments, etCO2 values may
equipment in the vicinity of the module can be lower than values observed at sea level, as
produce interference in the module and cause described by Dalton's law of partial pressures.
incorrect measurements. When using the module in high-altitude
environments, it is advisable to take this into
23 Do not use the module with nuclear spin
account and to consider adjusting etCO2 alarm
tomography (MRT, NMR, NMT) as the function of
the module may be disturbed. settings accordingly.
6 Electrical installation of the room or the building
24 Do not modify this equipment without in which the module is to be used must comply
authorization of the manufacturer. with regulations specified by the country in which
25 If this equipment is modified, appropriate the equipment is to be used.
inspection and testing must be conducted to 7 A strong magnetic field located 1 cm or less from
ensure continued safe use of the equipment. the MicroPod™ may temporarily affect
performance of the MicroPod™.
26 When using a sampling line for intubated
patients with a closed suction system, do not 8 Microstream™ etCO2 sampling lines are
place the airway adaptor between the suction designed for single patient use, and are not to be
catheter and endotracheal tube. This is to ensure reprocessed. Do not attempt to clean, disinfect,
that the airway adaptor does not interfere with sterilize or flush any part of the sampling line as
the functioning of the suction catheter. this can lead to damage to the module.
27 Loose or damaged connections may 9 Dispose of sampling lines and packaging
compromise ventilation or cause an inaccurate according to standard operating procedures or
measurement of respiratory gases. Securely local regulations for the disposal of contaminated
connect all components and check connections medical waste.
for leaks according to standard clinical 10 Before use, carefully read the Microstream™
procedures. etCO2 sampling lines Directions for Use.
11 Only use Microstream™ etCO2 sampling lines to
ensure the monitor functions properly.

34
Warnings and cautions

12 Ensure that tubing is not stretched during use. 10. Warnings & Cautions -
13 Use of a CO2 sampling line with H in its name OxyGenie®
(indicating that it is for use in humidified
environments) during MRI scanning may cause 10.1 Warnings for OxyGenie®
interference. These sampling lines include
1 Do not use OxyGenie® if the difference between
CapnoLine H/Long, CapnoLine H O2, Smart
SpO2 and SaO2 is greater than 5%.
CapnoLine H/Long, Smart CapnoLine H O2, and
Smart CapnoLine H Plus O2/Long. The use of 10.2 Cautions for OxyGenie®
non H sampling lines is advised.
1 An increasing requirement for oxygen while
14 CO2 sampling lines used with the monitor are
using OxyGenie® may be indicative of an
marked with the upper limit of oxygen that may
underlying condition which has to be addressed,
be provided with the sampling line. At levels of
even if SpO2 is within the target range.
oxygen provision higher than those marked on
the sampling line packaging, dilution of CO2 2 Before initiating (or re initiating) OxyGenie,
readings may occur, leading to lower CO2
check (and adjust if necessary) that the O2
values.
setting is appropriate for the patients current
15 When monitoring with capnography during clinical condition. This initial O2 setting optimises
sedation, please note that sedation may cause the initial response and initial response time of
hypoventilation and CO2 waveform distortion or
the algorithm.
disappearance. Waveform attenuation or
disappearance is an indicator that the status of 3 Additional ventilator independent patient
the patient’s airway should be assessed. monitoring (bedside vital monitoring blood gas
analyser) should be performed.
16 When monitoring patients during upper
endoscopy, partial blockage of the oral airway 10.3 Clinical warnings
due to endoscope positioning may cause periods
of low readings and rounded waveforms. The 1 Use of OxyGenie® is contraindicated on patients
occurrence will be more pronounced with high whose target SpO2 is outside the following target
oxygen delivery levels. ranges. 90-94%, 91-95%, 92-96%, 94-98%.
17 If CO2 insufflation is performed during CO2
monitoring, the EtCO2 values will accordingly
rise very significantly and this may result in
device alarms and abnormally high waveforms
until the CO2 is evacuated from the patient.

35
Warnings and cautions

This page is intentionally left blank.

36
Ventilator layout

Ventilator layout

37
Ventilator layout

11. Ventilator layout


This section details the physical features of a
SLE6000 infant ventilator.

10

1
5

4 3 2

9
8

11.1 Front
1 Mains power button (Ventilator On/Off control)
2 Proximal airway port (Pressure monitor port)
3 Fresh gas to patient port
4 Exhalation port from patient
5 Flow sensor (Electrical connector)
6 Touch screen
7 Exhalation block cover
8 Front lifting point
9 Trolley securing point
10 Light bar

38
Ventilator layout

11
30 29

28 27

25 26 12

24 23

20 13

15 14
22 21
19

17
16
18

11.2 Rear 24 EtCO2 electrical connector


11 Rear carry handle 25 RS232 interface (9 way D-sub)
12 Main cooling fan and filter 26 Aerogen Nebuliser power connector (USB)
13 IEC mains inlet socket 27 Nurse call electrical connector
14 Mains inlet cable locking clamp 28 Ethernet interface (RJ-45)
15 Equipotential stud 29 Data port (USB)
16 Exhaust port 30 VGA or DisplayPort output connector
17 Oxygen cell cover plate
18 Nebuliser port
19 Pressure relief valve and exhaust ports.
20 24V DC input electrical connector
21 Oxygen inlet port and water trap (Optional)
22 Air inlet port and water trap
23 SpO2 electrical connector

39
Ventilator layout

31

32

33

36 34

35

31 Air vent (Exhaust)


32 Software option ID stickers
33 Exhalation block flap
34 Exhalation block
35 Exhalation block clamp
36 Silencer

40
Ventilator setup

Ventilator setup

“Pre-use Inspection” on page 42


“Connection of equipotential bonding cable” on page 42
“Connection of mains power” on page 42
“Connection of 24V DC auxiliary power” on page 42
“Fitting the silencer and exhalation block” on page 43
“Gas connections” on page 43
“Turning the ventilator On” on page 44

41
Ventilator setup

12. Ventilator basic setup 12.3 Connection of mains power


This section details the setup of an in-service
SLE6000 infant ventilator. Note: Hospital environment may provide un-
switched sockets for medical devices.
12.1 Pre-use Inspection
12.3.1 IEC/BS 1363/A3 specification power leads
A. Check that the water trap/s are empty.
Insert the mains plug into
Caution. If the water trap/s are fitted with the the mains socket.
manual drain plug and contain water,
manually drain the water before proceeding
with the setup.

B. Check that the rear fan filter is free from dust.


Note: If the filter is dirty please follow the
cleaning procedure in the maintenance
section on page 235.

C. Ensure all covers are intact and that the Turn on the mains power
ventilator does not show signs of excessive wear or
corrosion on the visible metal parts.
12.2 Connection of equipotential
bonding cable
Note: If hospital guidelines require
equipotential bonding of the medical devices
connect as described below. (Equipotential
bonding involves connecting together all
12.3.2 Schuko and NEMA specification power
non-current carrying metalwork to form a
leads
zone within which it is not possible for
exposed metalwork to be at different voltage Insert the mains plug into
levels, which could cause a shock i.e. to the mains socket.
create an earthed equipotential zone).

The ventilator is equipped with one rear mounted


bonding point.

Connect the equipotential


bonding cable (1) to the 2
rear equipotential bonding
stud (2).  Note: Schuko lead shown.

1
12.4 Connection of 24V DC auxiliary
power
Connect the 24V DC
Connect the free end of power supply cable to
the equipotential bonding 4
the 24VDC auxiliary
cable from the ventilator
(3) to the equipotential
 power input connector
located on the rear of the
bonding point (4). ventilator.

Caution: Use only a medical grade 24V DC


power supply with a current rating of 4 A.

42
Ventilator setup

Fit the assembly to the


Note: The mains cable does not have to be
gas ports and lock in
disconnected when using the 24V DC
place.
auxiliary power.
Note: The user will
12.4.1 Mains or auxiliary power supply - power be unable to close
switch status indicator the access cover
When mains or auxiliary power is not unless the exhalation
connected to the ventilator the halo block is locked in
indicator around the mains switch will place.
be off.
Close the access cover.
When mains power or auxiliary is
connected to a ventilator that is "OFF" 12.6 Gas connections
the halo indicator around the mains
switch will illuminate. A static halo Warning. Check the condition of the gas
shows that the internal batteries are supply hoses to the ventilator. Do not use any
fully charged. hose that shows signs of cracking, abrasion,
kinking, splits, excessive wear or ageing.
A flashing halo shows that the internal Make sure that the Air or O2 hose has not
batteries are partially or fully dis- come into contact with oil or grease.
charged and they are charging.
Connect the Air and
Oxygen hoses to the rear
of the ventilator.
12.5 Fitting the silencer and exhalation
block Ensure the connecting
Open the exhalation nuts are hand tight.
block access cover.

Note: NIST connectors shown.

Connect the probes to


the wall connections

Clean the gas ports with


an alcohol wipe.

Note: BS probes shown.


Connect the Silencer and
exhalation block
together. 12.7 Ventilator - patient & operator
The relief valve balls position
 

indicate the rear of the In a standard setup the ventilator should be placed
exhalation block. to one side of the head end of the incubator/cot.
The operator position is standing in front of the
ventilator.
Note: Ensure that the silencer and Exhalation Routing of the patient circuit is left to the discretion
block have been cleaned in accordance with of the user.
the Cleaning and disinfection instructions on
Warning. Ensure that the water trap is always
page 235.
situated below the patient.

43
Ventilator setup

12.8 Turning the ventilator On 12.9 Pre-use functional test


12.8.1 With mains connected 12.9.1 Power on self test
Push and hold the mains switch for 3 Each time the ventilator is turned on it will perform a
seconds. power on self test (POST).
The POST checks the pneumatic unit for correct
The halo light should be amber (static function. Any issues will be shown by the machine
or flashing). displaying a technical alarm.
The ventilator also activates the visual and audible
The halo light should change colour to components of the alarm system.
green.
The ventilator will now power up and 1 Turn the unit on
enter standby mode.
2 Verify that the alarm light bar cycles Red,
Amber & Cyan.
The battery icon will be accompanied
by the mains power icon to show that 3 Verify that a single high priority audible alarm
the ventilator is running on mains was sounded.
power.
12.9.2 Reserve power check
12.8.2 Without mains connected Look at the battery status icon to see
Push and hold the mains switch for 3 the charge status of the reserve power
seconds. source.
The capacity is rated in a percentage
The halo light should be off. from 100% fully charged to 0% complete discharge.
If using the ventilator without the mains supply or
The halo light should change colour to the 24V DC supply the following is a guide to the
green. approximate operating time on the internal battery.
The ventilator will now power up and The ventilator will typically run for over 3 hours from
enter standby mode. 100% battery charge to complete discharge, both in
conventional and HFOV modes. Actual battery
The battery icon only will appear to discharge duration will depend on battery condition
show that the unit is running on battery and ventilation settings applied. Please refer to the
power. caution for actual safe operation times.

Note: After the unit enters Standby mode the


user will have to acknowledge the Mains Caution. When the ventilator internal power
power fail alarm message once the Calibrate source reaches 25% the user is required to
flow sensor/Flow sensor not connected transfer the patient to an alternate form of
alarms is cleared. ventilation if re-connection to the mains
supply is not possible. At 25% the ventilator
12.8.3 With DC power connected will display and sound the “Battery Low”
alarm.
Push and hold the mains switch for 3
seconds.

The halo light should be amber (static


or flashing).

The halo light should change colour to


green.
The ventilator will now power up and
enter standby mode.

The DC power icon will appear to


show that the unit is running on 24V
DC power.

44
Ventilator setup

12.9.3 Patient circuit selection 9 Disconnect the Air supply.


1 To carry out the patient circuit setup, as per 10 Ensure that the “No Air Supply” alarm is
chapter ’13. Patient circuit selection’ on page triggered.
50.
2 When the patient circuit has been assembled 11 Disconnect the Oxygen supply.
continue with one of the following tests 12 Ensure that the “No Gas” alarm is triggered.
• Invasive dual limb 13 Re-connect the Air supply.
Invasive test section ’12.9.5 Functional testing
(Invasive dual limb)’ on page 45. 14 Reset the low PIP alarm message.
• Non invasive dual limb 15 Ensure that the “No Oxygen Supply” alarm is
Non invasive test dual limb section ’12.9.6 triggered.
Functional testing (Non invasive dual limb)’ on 16 Reconnect the oxygen supply.
page 46.
17 Ensure all alarms cancel.
• Non invasive single limb
Non invasive test single limb section ’12.9.7 18 Select and enter HFOV mode.
Functional testing (Non invasive single limb)’ 19 Set a Delta P of 10 mbar.
on page 46.
20 Ensure that the ventilator is oscillating and that
12.9.4 Pre-functional test checks no alarms are present.
• Check that the humidifier is turned on. (Refer 21 Ensure that the set MAP and measured MAP
to the manufacturers instructions for more are within 1 mbar.
details).
• Check that the humidification chamber is filled Note: If the reading for step 21 is outside the
with appropriate sterile water to the designated stated tolerance check the patient circuit then
level. re-check.
• Check that the patient circuit heating connector 22 Remove the Fresh Gas limb.
is connected to the humidifier securely. (Refer
to the manufacturers instructions for more 23 Ensure that the “Leaking Fresh gas” alarm is
details). triggered.
• Check the patient circuit, make sure all the 24 Block the fresh gas port.
connections are secure and that the water trap 25 Ensure that the “Blocked Fresh gas” alarm is
is empty and positioned upright. triggered.
• Check that the humidifier temperature probes
26 Refit the Fresh Gas limb. Check that all the
are correctly inserted into the patient circuit
alarms clear.
monitoring ports.
27 Reconnect the flow sensor and flow sensor
12.9.5 Functional testing (Invasive dual limb)
cable.
1 Remove the flow sensor and test lung.
28 Calibrate the flow sensor.
2 Occlude the ET manifold.
29 Wait for the text “Calibration completed” to
3 Select and enter CMV mode. appear.
Note: If a 15 mm circuit is fitted select the 15 30 Refit the flow sensor and test lung.
mm patient circuit setting.
31 Disconnect the mains power supply.
4 Press “Continue without flow sensor” 32 Ensure that the “Mains Power Fail” alarm is
5 Set the low PEEP alarm threshold to -1 mbar. triggered. Check that the mains power symbol
disappears.
6 Ensure that the ventilator is cycling and that no
alarms are present. 33 Re-connect the mains power supply.

7 Ensure that the set PIP and measured PIP are 34 Ensure that the “Mains Power Fail” alarm
within 1 mbar. cancels. Check that the mains power symbol
reappears.
8 Ensure that the set PEEP and measured
35 Return to standby mode
PEEP are within 1 mbar.
36 Functional testing is now complete.
Note: If the readings for step 7 & 8 are outside
the stated tolerance check the patient circuit
then re-check.

45
Ventilator setup

12.9.6 Functional testing (Non invasive dual 24 Disconnect the mains power supply.
limb) 25 Ensure that the “Mains Power Fail” alarm is
Note: The non invasive ventilation does not triggered. Check that the mains power symbol
require the use of the flow sensor. If the flow disappears.
sensor or flow sensor cable is connected 26 Re-connect the mains power supply.
please disconnect prior to commencing the
27 Ensure that the “Mains Power Fail” alarm
functional test.
cancels. Check that the mains power symbol
1 Select and enter NIPPV D - dual limb mode. reappears.
28 Return to standby mode
2 Occlude the prongs.
29 Functional testing is now complete.
3 Set the low PEEP alarm threshold to -1 mbar.
4 Ensure that the ventilator is cycling and that no 12.9.7 Functional testing (Non invasive single
alarms are present. limb)
5 Ensure that the set PIP and measured PIP are Note: The non invasive ventilation does not
within 1 mbar. require the use of the flow sensor. If the flow
6 Ensure that the set PEEP and measured sensor or flow sensor cable is connected
PEEP are within 1 mbar. please disconnect prior to commencing the
functional test.
Note: If the readings for step 5 & 6 are outside
the stated tolerance check the patient circuit 1 Select and enter nCPAP single limb mode.
then re-check. 2 Occlude the prongs
7 Disconnect the Air supply. 3 Set the CPAP control to 5 mbar
8 Ensure that the “No Air Supply” alarm is 4 Ensure that the set CPAP and measured
triggered. CPAP are within 1 mbar.
9 Disconnect the Oxygen supply. 5 Disconnect the Air supply.
10 Ensure that the “No Gas” alarm is triggered. 6 Ensure that the “No Air Supply” alarm is
triggered.
11 Re-connect the Air supply.
7 Disconnect the Oxygen supply.
12 Reset the low PIP alarm message.
8 Ensure that the “No Gas” alarm is triggered.
13 Ensure that the “No Oxygen Supply” alarm is
triggered. 9 Re-connect the Air supply.
14 Reconnect the oxygen supply. 10 Reset the low PIP alarm message.
15 Ensure all alarms cancel. 11 Ensure that the “No Oxygen Supply” alarm is
triggered.
16 Remove the Fresh Gas limb.
12 Reconnect the oxygen supply.
17 Ensure that the “Leaking Fresh gas” alarm is
triggered. 13 Ensure all alarms cancel.
18 Block the fresh gas port. 14 Remove the Fresh Gas limb.
19 Ensure that the “Blocked Fresh gas” alarm is 15 Ensure that the “low pressure” alarm is
triggered. triggered.
20 Refit the Fresh Gas limb. Check that all the 16 Block the fresh gas port.
alarms clear. 17 Ensure that the “Blocked Fresh gas” alarm is
21 Select and enter NHFOV - dual limb mode. triggered.
22 Set a Delta P of 10 mbar. 18 Refit the Fresh Gas limb. Check that all the
alarms clear.
23 Ensure that the ventilator is oscillating and that
no alarms are present.Ensure that the set MAP 19 Disconnect the mains power supply.
and measured MAP are within 1 mbar. 20 Ensure that the “Mains Power Fail” alarm is
triggered. Check that the mains power symbol
Note: If the reading for step 23 is outside the disappears.
stated tolerance check the patient circuit then
re-check. 21 Re-connect the mains power supply.

46
Ventilator setup

22 Ensure that the “Mains Power Fail” alarm 12.10.1 Isolation from mains supply
cancels. Check that the mains power symbol To isolate the ventilator from the mains supply
reappears. remove the mains plug.
23 Return to standby mode
24 Functional testing is now complete.

12.10 Turning the ventilator Off


On completion of the session the user should enter
standby mode.


Press and hold the power button for 2


seconds.

Warning: Ensure that the ventilator is not


The information panel will be replaced by the positioned in such a way that it is difficult to
shutdown dialog box and button. operate the disconnection of the device.

Note: The shutdown dialog box will time out


after 10 seconds if no action is taken.

The user will have to repress the power switch


momentarily to cancel the “Power fail” audible
alarm.
Warning: If the audible power fail alarm does
not sound, remove the ventilator from service
and refer the unit for repair.

47
Ventilator setup

This page is intentionally left blank.

48
Patient circuits

Patient circuit selection


See “Assembly of BC6188 (Ø10 mm) or BC6198 (Ø15 mm) patient
circuit” on page 50.
See “Assembly of BC6188/DHW patient circuit” on page 54.
See “Modification of BC6188 or BC6188/DHW circuits for non-
invasive dual limb ventilation.” on page 57.
See “Modification of BC6188 or BC6188/DHW circuits for non-
invasive single limb ventilation.” on page 58.

49
Patient circuits

13. Patient circuit selection 13.1.4.1 Patient circuit selection


The invasive mode panel contains Patient Circuit
The SLE6000 has three patient circuits that are
two buttons that allow the user to 10mm
approved for use.
select between 10mm and 15mm
diameter patient circuits.
BC6188 Single use Neonatal/Infant breathing circuit
– 10mm tubing, single heated wire. (Conventional
and HFOV) Note: The selection of 15mm
patient circuits is only available
BC6188/DHW Single use Neonatal/Infant breathing for invasive ventilation. 15mm
circuit – 10/15mm tubing, dual heated wire. Changing to non-invasive
(Conventional and HFOV) ventilation automatically
selects 10mm patient circuits.
BC6198 Single use Paediatric breathing circuit –
15mm tubing (Conventional use only).

13.1 Type of ventilation 13.2 Assembly of BC6188 (Ø10 mm) or


BC6198 (Ø15 mm) patient circuit
13.1.1 Invasive
The following instruction covers the assembly of the
It is recommended for patients requiring tidal Ø10 mm BC6188 patient circuit (Neonatal) and the
volumes of less than 50 ml to use either BC6188 or Ø15 mm BC6198 patient circuit (Paediatric). Both
BC6188/DHW patient circuits for conventional and are single heated limb circuits.
oscillatory ventilation.
13.2.1 Bacterial filters
It is recommended for patients requiring tidal
Caution: The use of bacterial filters between
volumes of greater than 50 ml to use BC6198
the fresh gas port and humidifier supply line
patient circuits for conventional ventilation only.
& exhalation block and the expiratory supply
13.1.2 Non-Invasive (Dual limb) line is recommended.
Use either:
1 Fit the single use bacterial filter (A) to the
BC6188
exhalation port from patient port.
BC6188/DHW
2 Fit the single use bacterial filter (B) to the fresh
See “Modification of BC6188 or BC6188/DHW gas to patient port.
circuits for non-invasive dual limb ventilation.” on
page 57.

13.1.3 Non-Invasive (Single limb)


Use
BC6188.
BC6188/DHW
B

See “Modification of BC6188 or BC6188/DHW


circuits for non-invasive single limb ventilation.” on
page 58.

13.1.4 Non-Invasive O2 therapy (Single limb)


A
Use
BC6188.
Please refer to the consumable catalogue or the
BC6188/DHW SLE website for part numbers.
See “Modification of BC6188 or BC6188/DHW
circuits for non-invasive single limb O2 therapy.” on
page 61.

50
Patient circuits

13.2.2 Humidification chamber 2 Connect the 15mm female end (C) of the fresh
Ensure that the chamber is fitted securely to the gas supply line (D) to the to the bacterial filter
humidifier and filled to the correct level with sterile fitted to the ventilator port marked “Fresh Gas to
water.. Patient” (E).



C


D

Note: These instructions are illustrated with a


standard single use humidification chamber.
Auto fill and reusable chambers can also be


used. Reusable chambers will require the use F


of an adaptor for the fresh gas supply. G
Note: Please refer to the humidifier user
manual for warnings, cautions and operating
instructions.
Please refer to patient circuit instructions for
use for warnings and cautions and operating
instructions.

1 Remove the patient circuit from protective bag. 3 Connect the free end (F) of the fresh gas supply
line (D) to one of the ports of the humidification
Note: The BC6188 circuit is not supplied with chamber (G).
a humidification chamber (G).
4 The remaining section of the circuit is supplied
assembled.
5 Connect the heated limb (H) to the free port of
the humidification chamber (I).

H

I

51
Patient circuits

6 Connect the exhalation limb (J) to the bacterial 9 Ensure the clip (P) is placed over the
filter fitted to the exhalation port (K) marked temperature probe to ensure correct orientation.
“Exhalation port from Patient”.



K

J
13.2.4 Fitting the temperature probes to a
BC6198 patient circuit
10 Connect the humidifier temperature probes to
ports (N & O).

O
N



Warning. Ensure that the water trap is always 11 Ensure the clip (P) is placed over the
situated lower than the patient. temperature probe to ensure correct orientation.

7 Connect the proximal airway line (L) to the


proximal airway port (M) marked “Proximal P


Airway”.
M
L

12 Connect the humidifier heater wire lead (Q) to


the port on the inspiratory heated limb (H).

13.2.3 Fitting the temperature probes to a  H Q


BC6188 patient circuit
8 Connect the humidifier temperature probes to
ports (N & O).
O

N 13 Connect the heater wire (Q) and the temperature

probes (R) to the humidifier.

R

Q

52
Patient circuits

14 Connect the flow sensor cable (S) to the 13.2.5 Fitting the flow sensor to a BC6188
electrical connector on the front of the ventilator patient circuit
marked “Flow sensor” (T). 21 Remove the dust cap (U)
from the ET manifold (V). V U


T

S
22 Insert the flow sensor (W)
into the ET manifold (V).
V W


23 The patient circuit is now
ready to use.
15 Connect the flow
sensor cable to the
flow sensor. Ensure
that the cable
connector key fits into

the rear notch of the Note: Application of the ET tube is not


flow sensor connector. covered in this manual.

13.2.6 Fitting the flow sensor to a BC6198


patient circuit
24 Remove the dust cap (U)
Note: If the patient circuit is being assembled from the ET manifold (V). U
with the ventilator turned off skip steps 16
and 20.
V


16 The ventilator will alarm calibrate flow sensor.
Press the “Calibrate” button in the information
bar to activate the sensor panel or press the
“Utilities” button or the “Calibration and Utilities”
Button.
17 Occlude the flow 25 Insert the flow sensor (W)
into the ET manifold (V).
W
sensor to prevent any

flow across the sensor 26 The patient circuit is now


wires. V

ready to use.

Caution: To avoid contamination of the flow


sensor use gloves when calibrating. Note: Application of the ET tube is not
covered in this manual.
18 Press the Start calibration button and the
following text “Calibrating..” will be displayed
above the button 13.2.7 Fitting the test lung
Once the patient circuit is assembled connect the
19 When the calibrations has passed the test test lung (X) to the flow sensor (W). The circuit is
“Calibration completed” will appear. ready for pre use functional testing.
20 The flow sensor is now calibrated.
W
X

53
Patient circuits

13.3 Assembly of BC6188/DHW patient


circuit Note: This setup requires a dual heater wire
The following instruction covers the assembly of the lead.
Ø10 mm BC6188/DHW patient circuit (Neonatal) a
dual heated limb circuit. 1 Remove the patient circuit from protective bag.
2 Connect the 15mm female end (C) of the fresh
13.3.1 Bacterial filters gas supply line (D) to the to the bacterial filter
Caution: The use of bacterial filters between fitted to the ventilator port marked “Fresh Gas to
the fresh gas port and humidifier supply line Patient” (E).
& exhalation block and the expiratory supply
line is recommended. E


1 Fit the single use bacterial filter (A) to the
exhalation port from patient port. 
2 Fit the single use bacterial filter (B) to the fresh
gas to patient port. C


D

B


F


G
A
Please refer to the consumable catalogue or the
SLE website for part numbers.

13.3.2 Humidification chamber


Ensure that the chamber is fitted securely to the
humidifier and filled to the correct level with sterile
water..
3 Connect the free end (F) of the fresh gas supply
line (D) to one of the ports of the humidification
chamber (G).
4 The remaining section of the circuit is supplied
assembled.

Note: Please refer to the humidifier user


manual for warnings, cautions and operating
instructions.
Please refer to patient circuit instructions for
use for warnings and cautions and operating
instructions.

54
Patient circuits

5 Connect the heated limb (H) to the free port of 8 Connect the humidifier temperature probes to
the humidification chamber (I). ports (N & O).
O
H 
 N


I

 9 Ensure the clip (P) is placed over the


temperature probe to ensure correct orientation.


6 Connect the exhalation limb (J) to the bacterial
filter fitted to the exhalation port (K) marked
“Exhalation port from Patient”.

10 Connect the inspiratory limb heater wire lead to


 the port (Q) on the inspiratory heated limb (H).
K

 H Q

11 Connect the expiratory heater wire lead to the


port (Q) on the expiratory heated limb (R).

Q

7 Connect the proximal airway line (L) to the


proximal airway port (M) marked “Proximal
Airway”.

M
L


R

55
Patient circuits

12 Connect the heater wire (S) and the temperature 17 Press the Start calibration button and the
probes (T) to the humidifier. following text “Calibrating..” will be displayed
above the button
18 When the calibrations has passed the test
“Calibration completed” will appear.
19 The flow sensor is now calibrated.
 S
20 Remove the dust cap (W)
from the ET manifold (X). X W



T
13 Connect the flow sensor cable (U) to the
electrical connector on the front of the ventilator
marked “Flow sensor” (V). 21 Insert the flow sensor (Y)
into the ET manifold (V).
V Y


U 22 The patient circuit is now
ready to use.


V
Note: Application of the ET tube is not
covered in this manual.

14 Connect the flow 13.3.3 Fitting the test lung


sensor cable to the Once the patient circuit is assembled connect the
flow sensor. Ensure test lung (Z) to the flow sensor (Y). The circuit is
that the cable ready for pre use functional testing.
connector key fits into
Y

the rear notch of the


flow sensor connector.
Z

Note: If the patient circuit is being assembled


with the ventilator turned off skip steps 15
and 19.

15 The ventilator will alarm calibrate flow sensor.


Press the “Calibrate” button in the information
bar to activate the sensor panel or press the
“Utilities” button or the “Calibration and Utilities”
Button.
16 Occlude the flow
sensor to prevent any

flow across the sensor


wires.

Caution: To avoid contamination of the flow


sensor use gloves when calibrating .

56
Patient circuits

13.4 Modification of BC6188 or BC6188/ 6 Insert the adaptor (G) into the expiratory limb
DHW circuits for non-invasive dual (D).
limb ventilation.
Note: The flow sensor and flow sensor cable G


are not required for this set up. D


1 Assemble the BC6188 patient circuit as per
section 13.2 on page 50 or the BC6188/DHW
patient circuit section 13.3 on page 54.
2 Disconnect the proximal airway line (A) from the
ET manifold (B) at the luer connector. 13.4.1 Fitting a dual limb nCPAP generator.
7 Remove the nCPAP generator (H) from it

B packaging.
8 Connect the generator into the inspiratory limb
(C) and expiratory limb of (D) the patient circuit.

A


H

3 Disconnect the ET manifold (B) form the


inspiratory limb (C) and expiratory limb (D). D
C


B
D

C

Note: Application of the prongs/mask are not


covered in this manual. Please refer to the
4 Remove the luer adaptor (E) from the accessory instruction for use supplied with the nCPAP
bag supplied with the circuit. generator.

E

5 Connect the proximal airway line (F) to the


adaptor.

57
Patient circuits

13.5 Modification of BC6188 or BC6188/ 1 Remove the patient circuit from protective bag.
DHW circuits for non-invasive
single limb ventilation. Note: The BC6188 circuit is not supplied with
a humidification chamber (G).
Note: The flow sensor and flow sensor cable
are not required for this set up. 2 Connect the 15mm female end (C) of the fresh
gas supply line (D) to the to the bacterial filter
13.5.1 Bacterial filters fitted to the ventilator port marked “Fresh Gas to
Patient” (E).
Caution: The use of bacterial filters between
the fresh gas port and humidifier supply line E


& exhalation block and the expiratory supply
line is recommended.

1 Fit the single use bacterial filter (A) to the fresh 


gas to patient port (B).
C


D

A


B
G


F


Please refer to the consumable catalogue or the
SLE website for part numbers.

13.5.2 Humidification chamber


Ensure that the chamber is fitted securely to the
humidifier and filled to the correct level with sterile
water..

3 Connect the free end (F) of the fresh gas supply


line (D) to one of the ports of the humidification
chamber (G).

Note: Please refer to the humidifier user


manual for warnings, cautions and operating
instructions.
Please refer to patient circuit instructions for
use for warnings and cautions and operating
instructions.

58
Patient circuits

4 Disconnect the inspiratory limb (H) from the 6 Connect the heated limb (H) to the free port of
circuit at the temperature probe port and the humidification chamber (G).
proximal airway line (I) from ET manifold by
unscrewing the luer connector.

 
H

7 Connect the proximal airway line (K) to the


bacterial filter fitted to the proximal airway port
(L) marked “Proximal Airway”.

L

K

H

J
13.5.3 Fitting the temperature probes
8 Connect the humidifier temperature probes to
ports (M & N).
N

M

9 Ensure the clip (O) is placed over the


temperature probe to ensure correct orientation.

O

10 Connect the humidifier heater wire lead (O) to


the port on the inspiratory heated limb (H).
5 Replace the remaining part of the circuit (J) back
into its original packaging.
 H O

59
Patient circuits

11 Connect the heater wire (O) and the temperature


probes (P) to the humidifier. Note: Application of the prongs/mask are not
covered in this manual. Please refer to the
instruction for use supplied with the nCPAP
generator.

O

P

13.5.4 Fitting a single limb nCPAP generator.


12 Remove the nCPAP generator (Q) from its
packaging.
13 Connect the generator into the inspiratory (H)
limb of the patient circuit.

Q

14 Connect the proximal airway line (I) to the


pressure monitoring line port (R) on the nCPAP
generator.

R


60
Patient circuits

13.6 Modification of BC6188 or BC6188/


DHW circuits for non-invasive Note: Please refer to the humidifier user
single limb O2 therapy. manual for warnings, cautions and operating
instructions.
Note: The flow sensor and flow sensor cable
are not required for this set up. Please refer to patient circuit instructions for
use for warnings and cautions and operating
13.6.1 Bacterial filters instructions.
Caution: The use of bacterial filters between 1 Remove the patient circuit from protective bag.
the fresh gas port and humidifier supply line
& exhalation block and the expiratory supply Note: The BC6188 circuit is not supplied with
line is recommended. a humidification chamber (G).

1 Fit the single use bacterial filter (A) to the fresh 2 Connect the 15mm female end (C) of the fresh
gas to patient port (B). gas supply line (D) to the to the bacterial filter
fitted to the ventilator port marked “Fresh Gas to
Patient” (E).
E


A

 C
B


D

Please refer to the consumable catalogue or the


SLE website for part numbers.

13.6.2 Humidification chamber


Ensure that the chamber is fitted securely to the
G

humidifier and filled to the correct level with sterile
F
water.. 

3 Connect the free end (F) of the fresh gas supply


line (D) to one of the ports of the humidification
chamber (G).

61
Patient circuits

4 Disconnect the inspiratory limb (H) from the 6 Connect the heated limb (H) to the free port of
circuit at the temperature probe port. the humidification chamber (G).

 
H

13.6.3 Fitting the temperature probes


7 Connect the humidifier temperature probes to
ports (K & L).
L

H
K


J

8 Ensure the clip (M) is placed over the


temperature probe to ensure correct orientation.

M

9 Connect the humidifier heater wire lead (N) to


the port on the inspiratory heated limb (H).

 H N

5 Replace the remaining part of the circuit (J) back


into its original packaging.

62
Patient circuits

10 Connect the heater wire (O) and the temperature


probes (P) to the humidifier. Caution: Select the correct size nasal
cannula, the nasal prong outer diameter
should be approximately half the diameter of
the infant’s nares.

O

P

13.6.4 Fitting a oxygen therapy nasal cannula.


Note: The user will need to use the O2 therapy
patient circuit adaptor N4318 (R) to connect
the cannula to the therapy circuit.

11 Remove the (Q) from it packaging.


12 Connect the cannula to the inspiratory limb (H) of
the patient circuit using the adaptor (R).

R

Q

R


H
G

Note: Application of the cannula is not


covered in this manual. Please refer to the
instruction for use supplied with the cannula.

63
Patient circuits

This page is intentionally left blank.

64
Ventilation - Invasive

Ventilation - Invasive
“CPAP” on page 66

“CMV” on page 68

“PTV” on page 70

“PSV” on page 72

“SIMV” on page 74

“HFOV” on page 76

“HFOV+CMV” on page 78

65
Ventilation - Invasive

14. Ventilation - Invasive


14.1 CPAP

Mode type: Invasive Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.

RR backup
Press and hold Trigger sensitivity
the control for 2 The operation of the Trigger
seconds to sensitivity control is modified when
Additional switch On/Off. no flow sensor is connected. The
Parameters Press confirm to Rise time sensitivity unit changes from l/min to
Active for 120 acknowledge. Alters the percentage (%).
seconds when (Default 40 BPM pressure wave The default is changed from 0.6 l/
mode selected. when On). shape. min to 50%.

RR Backup Rise time Trig Sens


Additional
Parameters

BPM Seconds l/min

Ti CPAP PIP O2
Manual
Breath

Seconds mbar mbar %

Manual breath Ti CPAP PIP O2


Inspiratory Continuous Peak inspiratory Oxygen
time positive airway pressure in concentration
The inspiration pressure in mbar. For delivered to
time in seconds. mbar. manual and patient.
backup breaths.
Alternate Interactive controls Interactive controls Alternate
function A. The Ti control cannot be The CPAP control cannot be function
Inspiratory hold. increased beyond the set RR increased beyond the set PIP. The O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set CPAP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti. +

Auto O2

Note. The above values are shown at their


factory default settings.

66
Ventilation - Invasive

CPAP RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
Vmin BPM too high.
Vte Set maximum and Apnoea
Set maximum and minimum Set maximum
minimum thresholds. Apnoea time limit.
thresholds. (Thresholds Can be set to Off
(Thresholds invisible) (See warning Leak
invisible) High Alarm name: below) (Thresholds O2 % Set maximum
High Alarm name: Minute volume high invisible) Set maximum percentage leak
Tidal volume above threshold exceeded Alarm name: threshold. threshold.
high threshold Low Alarm name: Period between (Thresholds (Thresholds
Low Alarm name: Minute volume patient effort invisible) invisible)
Tidal volume below below low exceeds apnoea Alarm name: Alarm name:
low threshold. threshold. limit. O2 over set limit. High patient leak.
Vte Vmin RR O2 Leak
(ml) (l) (BPM) (%) (%)


30.0 18.00 100 60 35
7.0 0.25 0 21 0

 00.0 00.0
Apnoea
(seconds)

15
PIP CPAP etCO2 SpO2 PR
(mbar) (mbar) (mmHg) (%) (min)



20 7.0 50 99 180
15.0 4.0 -- -- --


11 1 20 88 100
Warning: PIP CPAP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name: etCO2 SpO2 PR
use an PIP too high PEEP too high
Set maximum and Set maximum and Set maximum and
alternative (Threshold Visible) (Threshold
minimum etCO2 minimum SpO2 minimum pulse rate
method of Low Alarm name: Invisible)
detecting an PIP too low Low Alarm name: thresholds. thresholds. Only
thresholds. Only
apnoeic (Threshold Pressure below low Only active when active when SpO2
active when SpO2
episode, with Invisible). threshold etCO2 module module connected.
module connected.
the Apnoea (Threshold Visible). connected.
alarm turned
“OFF”.

67
Ventilation - Invasive

14.2 CMV

Prior to and after connection, it is the user’s responsibility to adjust and monitor the
Mode type: Invasive ventilation parameters.

Additional
Parameters Rise time
Active for 120 Alters the
seconds when pressure wave
mode selected. shape.

RR Backup Rise time


Additional
Parameters

Seconds

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual breath RR Ti PEEP PIP VTV O2


Respiratory rate Inspiratory Positive Peak inspiratory Press and hold Oxygen
in breath per time expiratory end pressure in the control for 2 concentration
minute. The inspiration pressure in mbar. For seconds to delivered to
time in seconds. mbar. manual and switch On/Off. patient.
backup breaths. Press confirm to
acknowledge.
Alternate Interactive controls PIP MAX VTV Target Alternate
function A. The Ti control cannot be When VTV is on When VTV is on function
Inspiratory hold. increased beyond the set RR the control is the control is O2 Boost
backup rate. renamed PIP renamed VTV O2 suction
B. The RR backup rate control MAX. Use to set target. Use to
cannot be increased beyond the the maximum set the target
allowable Ti.. allowable PIP. volume.
C. The Rise time cannot be
increased beyond the set Ti. +

Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.

Note. The above values are shown at their


factory default settings.

68
Ventilation - Invasive

CMV
default alarm
thresholds

Vmin
Vte Set maximum and
Set maximum and minimum
minimum thresholds.
thresholds. (Thresholds
(Thresholds invisible) Leak
invisible) High Alarm name: O2 % Set maximum
High Alarm name: Minute volume high Set maximum percentage leak
Tidal volume above threshold exceeded threshold. threshold.
high threshold Low Alarm name: (Thresholds (Thresholds
Low Alarm name: Minute volume invisible) invisible)
Tidal volume below below low Alarm name: Alarm name:
low threshold. threshold. O2 over set limit. High patient leak.
Vte Vmin O2 Leak
(ml) (l) (%) (%)


30.0 18.00 60 35
7.0 0.25 21 0


00.0 00.0

PIP PEEP etCO2 SpO2 PR


(mbar) (mbar) (mmHg) (%) (min)


20 7.0 50 99 180
15.0 4.0 -- -- --


11 1 20 88 100
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name: etCO2 SpO2 PR
PIP too high PEEP too high Set maximum and Set maximum and Set maximum and
(Threshold Visible) (Threshold minimum etCO2 minimum SpO2 minimum pulse rate
Low Alarm name: Invisible) thresholds. Only
PIP too low Low Alarm name: thresholds. thresholds. Only
active when SpO2
(Threshold Pressure below low Only active when active when SpO2
etCO2 module module connected.
Invisible). threshold module connected.
(Threshold Visible). connected.

69
Ventilation - Invasive

14.3 PTV

Prior to and after connection, it is the user’s responsibility to adjust and monitor the
Mode type: Invasive ventilation parameters.

Trigger sensitivity
The operation of the Trigger
sensitivity control is modified when
Additional no flow sensor is connected. The
Parameters Rise time sensitivity unit changes from l/min to
Active for 120 Alters the percentage (%).
seconds when pressure wave The default is changed from 0.6 l/
mode selected. shape. min to 50%.

RR Backup Rise time Trig Sens


Additional
Parameters

Seconds l/min

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual breath RR Ti PEEP PIP VTV O2


Respiratory rate Inspiratory Positive end Peak inspiratory Press and hold Oxygen
in breath per time expiratory pressure in the control for 2 concentration
minute. The inspiration pressure in mbar. For seconds to delivered to
time in seconds. mbar. manual and switch On/Off. patient.
backup breaths. Press confirm to
acknowledge.
Alternate Interactive controls PIP MAX VTV Target Alternate
function A. The Ti control cannot be When VTV is on When VTV is on function
Inspiratory hold. increased beyond the set RR the control is the control is O2 Boost
backup rate. renamed PIP renamed VTV O2 suction
B. The RR backup rate control MAX. Use to set target. Use to
cannot be increased beyond the the maximum set the target
allowable Ti.. allowable PIP. volume.
C. The Rise time cannot be
increased beyond the set Ti. +

Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.

Note. The above values are shown at their


factory default settings.

70
Ventilation - Invasive

PTV RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
Vmin BPM too high
Vte Set maximum and Apnoea
Set maximum and minimum Set max Apnoea
minimum thresholds. time limit. Set to Off
thresholds. (Thresholds as default (See
(Thresholds invisible) warning below) Leak
invisible) High Alarm name: (Thresholds O2 % Set maximum
High Alarm name: Minute volume high invisible) Set maximum percentage leak
Tidal volume above threshold exceeded Alarm name: threshold. threshold.
high threshold Low Alarm name: Period between (Thresholds (Thresholds
Low Alarm name: Minute volume patient effort invisible) invisible)
Tidal volume below below low exceeds apnoea Alarm name: Alarm name:
low threshold. threshold. limit. O2 over set limit. High patient leak.
Vte Vmin RR O2 Leak
(ml) (l) (BPM) (%) (%)


30.0 18.00 100 60 35
7.0 0.25 0 21 0


00.0 00.0
Apnoea
(seconds)

OFF
PIP PEEP etCO2 SpO2 PR
(mbar) (mbar) (mmHg) (%) (min)



20 7.0 50 99 180
15.0 4.0 -- -- --


11 1 20 88 100
Warning: PIP PEEP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name: etCO2 SpO2 PR
use an PIP too high PEEP too high
alternative (Threshold Visible) (Threshold Set maximum and Set maximum and Set maximum and
method of Low Alarm name: Invisible) minimum etCO2 minimum SpO2 minimum pulse rate
detecting an PIP too low Low Alarm name: thresholds. Only
thresholds. thresholds. Only
apnoeic (Threshold Pressure below low active when SpO2
Only active when active when SpO2
episode, with Invisible). threshold etCO2 module module connected.
module connected.
the Apnoea (Threshold Visible). connected.
alarm turned
“OFF”

71
Ventilation - Invasive

14.4 PSV

Prior to and after connection, it is the user’s responsibility to adjust and monitor the
Mode type: Invasive ventilation parameters.
Trigger
sensitivity
The operation of
the Trigger
sensitivity
control is
modified when
no flow sensor is
connected. The
sensitivity unit
changes from l/ Termination
Additional min to sensitivity
Parameters Rise time percentage (%). Sets the
Active for 120 Alters the The default is termination
seconds when pressure wave changed from sensitivity the
mode selected. shape. 0.6 l/min to 50%. patient breath.

RR Backup Rise time Trig Sens Term Sens


Additional
Parameters

l/min %
Seconds

RR Ti Max PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual breath RR Ti Max PEEP PIP VTV O2


Respiratory rate Inspiratory Positive end Peak inspiratory Press and hold Oxygen
in breath per time expiratory pressure in the control for 2 concentration
minute. The inspiration pressure in mbar. For seconds to delivered to
time in seconds. mbar. manual and switch On/Off. patient.
backup breaths. Press confirm to
acknowledge.
Alternate Interactive controls PIP MAX VTV Target Alternate
function A. The Ti control cannot be When VTV is on When VTV is on function
Inspiratory hold. increased beyond the set RR the control is the control is O2 Boost
backup rate. renamed PIP renamed VTV O2 suction
B. The RR backup rate control MAX. Use to set target. Use to
cannot be increased beyond the the maximum set the target
allowable Ti. allowable PIP. volume.
C. The Rise time cannot be
increased beyond the set Ti. +

Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.

Note. The above values are shown at their


factory default settings.

72
Ventilation - Invasive

PSV RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
Vmin BPM too high
Vte Set maximum and Apnoea
Set maximum and minimum Set max Apnoea
minimum thresholds. time limit. Set to Off
thresholds. (Thresholds as default (See
(Thresholds invisible) warning below) Leak
invisible) High Alarm name: (Thresholds O2 % Set maximum
High Alarm name: Minute volume high invisible) Set maximum percentage leak
Tidal volume above threshold exceeded Alarm name: threshold. threshold.
high threshold Low Alarm name: Period between (Thresholds (Thresholds
Low Alarm name: Minute volume patient effort invisible) invisible)
Tidal volume below below low exceeds apnoea Alarm name: Alarm name:
low threshold. threshold. limit. O2 over set limit. High patient leak.
Vte Vmin RR O2 Leak
(ml) (l) (BPM) (%) (%)


30.0 18.00 100 60 35
7.0 0.25 0 21 0


00.0 00.0
Apnoea
(seconds)

OFF
PIP PEEP etCO2 SpO2 PR
(mbar) (mbar) (mmHg) (%) (min)



20 7.0 50 99 180
15.0 4.0 -- -- --


11 1 20 88 100
Warning: PIP PEEP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name: etCO2 SpO2 PR
use an PIP too high PEEP too high
alternative (Threshold Visible) (Threshold Set maximum and Set maximum and Set maximum and
method of Low Alarm name: Invisible) minimum etCO2 minimum SpO2 minimum pulse rate
detecting an PIP too low Low Alarm name: thresholds. Only
thresholds. thresholds. Only
apnoeic (Threshold Pressure below low active when SpO2
Only active when active when SpO2
episode, with Invisible). threshold etCO2 module module connected.
module connected.
the Apnoea (Threshold Visible). connected.
alarm turned
“OFF”

73
Ventilation - Invasive

14.5 SIMV

Prior to and after connection, it is the user’s responsibility to adjust and monitor the
Mode type: Invasive ventilation parameters.
Trigger
sensitivity
The operation of
the Trigger
sensitivity
control is
modified when
Pressure no flow sensor Termination
Support is connected. sensitivity
Press and hold The sensitivity Sets the
the control for 2 unit changes termination
seconds to from l/min to sensitivity the
Additional switch On/Off. percentage (%). patient breath.
Parameters Rise time Press confirm to The default is This parameter
Active for 120 Alters the acknowledge. changed from is on only when
seconds when pressure wave (Default 8 mbar 0.6 l/min to pressure
mode selected. shape. when On). 50%. support is on.

RR Backup Rise time P Support Trig Sens Term Sens


Additional
Parameters

Seconds mbar l/min %

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual breath RR Ti PEEP PIP VTV O2


Respiratory rate Inspiratory Positive end Peak inspiratory Press and hold Oxygen
in breath per time expiratory pressure in the control for 2 concentration
minute. The inspiration pressure in mbar. For seconds to delivered to
time in seconds. mbar manual and switch On/Off. patient.
backup breaths. Press confirm to
acknowledge.
Alternate Interactive controls PIP MAX VTV Target Alternate
function A. The Ti control cannot be When VTV is on When VTV is on function
Inspiratory hold increased beyond the set RR the control is the control is O2 Boost
backup rate. renamed PIP renamed VTV O2 suction
B. The RR backup rate control MAX. Use to set target. Use to
cannot be increased beyond the the maximum set the target
allowable Ti. allowable PIP. volume.
C. The Rise time cannot be
increased beyond the set Ti +

Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.

Note. The above values are shown at their


factory default settings.

74
Ventilation - Invasive

SIMV RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
Vmin BPM too high
Vte Set maximum and Apnoea
Set maximum and minimum Set max Apnoea
minimum thresholds. time limit. Set to Off
thresholds. (Thresholds as default (See
(Thresholds invisible) warning below) Leak
invisible) High Alarm name: (Thresholds O2 % Set maximum
High Alarm name: Minute volume high invisible) Set maximum percentage leak
Tidal volume above threshold exceeded Alarm name: threshold. threshold.
high threshold Low Alarm name: Period between (Thresholds (Thresholds
Low Alarm name: Minute volume patient effort invisible) invisible)
Tidal volume below below low exceeds apnoea Alarm name: Alarm name:
low threshold. threshold. limit. O2 over set limit. High patient leak.
Vte Vmin RR O2 Leak
(ml) (l) (BPM) (%) (%)


30.0 18.00 100 60 35
7.0 0.25 0 21 0


00.0 00.0
Apnoea
(seconds)

OFF
PIP PEEP etCO2 SpO2 PR
(mbar) (mbar) (mmHg) (%) (min)



20 7.0 50 99 180
15.0 4.0 -- -- --


11 1 20 88 100
Warning: PIP PEEP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name: etCO2 SpO2 PR
use an PIP too high PEEP too high Set maximum and Set maximum and Set maximum and
alternative (Threshold Visible) (Threshold minimum etCO2 minimum SpO2 minimum pulse rate
method of Low Alarm name: Invisible) thresholds. Only
thresholds. thresholds. Only
detecting an PIP too low Low Alarm name: active when SpO2
Only active when active when SpO2
apnoeic (Threshold Pressure below low
etCO2 module module connected. module connected.
episode, with Invisible). threshold
the Apnoea (Threshold Visible). connected.
alarm turned
“OFF”

75
Ventilation - Invasive

14.6 HFOV

Mode type: Invasive Prior to and after connection, it is the user’s responsibility to adjust and
monitor the ventilation parameters.
Oscillation Interactive controls
Pause The sigh RR cannot be increased
The oscillations beyond the limit dictated by the set
can be paused sigh inspiratory time. The sigh
for 60 seconds inspiratory time cannot be increased
by pressing the beyond the limit set by the set sigh
oscillation RR.
paused button. Sigh RR
Press and hold Press and hold
the control for 1 the control for 2 ΔP MAX
seconds to seconds to When the VTV
switch On/Off. switch On/Off. control is ON
Press confirm to the control is
acknowledge. renamed ΔP
Additional (Default 30 BPM Sigh Ti Sigh P MAX. The
Parameters when On). Sets Sets the Sets the maximum
Active for 120 the respiratory inspiratory time inspiratory allowable Delta
seconds when rate for the sigh for the sigh pressure for the pressure in
mode selected. breaths. breath. sigh breath. mbar.

Oscillation
Pause

Sigh RR Sigh Ti P Support Sigh P


Additional
Parameters

BPM Seconds mbar

Frequency I:E MAP ΔP VTV O2

Sigh

Hz Ratio mbar mbar ml %

Sigh* Frequency I:E MAP ΔP VTV O2


The sigh control HFO frequency Ratio for Mean airway Delta pressure Press and hold Oxygen
will initiate a in Hertz (Hz). inspiration to pressure in in mbar. the control for 2 concentration
pause at the set expiration (1:1, mbar. seconds to delivered to
Sigh Ti. 1:2 & 1:3). switch On/Off. patient.
Press confirm to
acknowledge.
Alternate Interactive controls Interactive controls Vte Target Alternate
function The Sigh Hold will use the user MAP and Sigh P When VTV is on function
Sigh hold. preference set 5 or 10 second A. The MAP control will the control is O2 Boost
pause. automatically start to increase the renamed VTV O2 suction
Sigh P when it passes the set level target. Use to
of Sigh P and the Sigh P will track set the target
the MAP. volume.
Caution*: With the Sigh RR set to Off the Sigh Ti can B. If the MAP is decreased the Sigh
be set anywhere between 0.1 and 3 seconds for
manual sighs. When Sigh RR is subsequently
P will remain at the new level. In this +
case the difference between MAP
turned on the Sigh Ti could be incompatible with the and Sigh P can be greater than 15
set Sigh RR. The user will have to adjust the Sigh Ti mbar.
or the Sigh RR accordingly. D. The Sigh P can be increased
independently of the set MAP but Auto O2
only 15 mbar above the set MAP.
Note. The Alternate
above values function with
are shown at Interactive
their factory controls
default Frequency and VTV target
settings. Pressing and holding the Frequency control for 2 seconds will link it to the Vte target control.
Increasing or decreasing the HFO Frequency will automatically adjust the Vte target control.

76
Ventilation - Invasive

HFOV
default alarm
thresholds

Vmin
Vte Set maximum and
Set maximum and minimum
minimum thresholds.
thresholds. (Thresholds
(Thresholds invisible) Leak
invisible) High Alarm name: O2 % Set maximum
High Alarm name: Minute volume high Set maximum percentage leak
Tidal volume above threshold exceeded threshold. threshold.
high threshold Low Alarm name: (Thresholds (Thresholds
Low Alarm name: Minute volume invisible) invisible)
Tidal volume below below low Alarm name: Alarm name:
low threshold. threshold. O2 over set limit. High patient leak
Vte Vmin O2 Leak
(ml) (l) (%) (%)


30.0 18.00 60 35
7.0 0.25 21 0


00.0 00.0
Paw Paw SpO2 PR
(mbar) (mbar) (%) (min)



17 99 180
5.0 2.0 -- --


-7 88 100
High Paw Low Paw
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: Low Alarm name: SpO2 PR
High Paw Low Pressure
(Threshold Visible). (Threshold Visible). Set maximum and Set maximum and
minimum SpO2 minimum pulse rate
thresholds. Only thresholds. Only
active when SpO2 active when SpO2
module connected. module connected.

77
Ventilation - Invasive

14.7 HFOV+CMV

Mode type: Invasive Prior to and after connection, it is the user’s responsibility to adjust and
monitor the ventilation parameters.
Oscillation
Pause
The oscillations
can be paused
for 60 seconds
by pressing the
oscillation
paused button.
Press and hold
the control for 1 HFO Activity
seconds to Allows the
switch On/Off. selection of
oscillations in
Additional both inspiratory
Parameters and expiratory
Active for 120 phases. or just
seconds when the expiratory
mode selected. phase.

Oscillation
Pause

HFO Activity
Additional
Parameters

RR Ti Frequency PEEP PIP ΔP O2

BPM Hz mbar mbar mbar %


Seconds

RR Ti Frequency PEEP PIP ΔP O2


Respiratory rate Inspiratory HFO frequency Positive end Peak inspiratory Delta pressure Oxygen
in breath per time in Hertz (Hz) expiratory pressure in in mbar. concentration
minute. The inspiration pressure in mbar. For delivered to
time in seconds. mbar manual and patient.
backup breaths.
Interactive controls Interactive controls Alternate
A. The Ti control cannot be The PEEP control cannot be function
increased beyond the set RR increased beyond the set PIP. The O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti +

Auto O2

Note. The above values are shown at their


factory default settings.

78
Ventilation - Invasive

HFOV+CMV
default alarm
thresholds

O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)


60
21

Paw Paw SpO2 PR


(mbar) (mbar) (%) (min)



17 99 180
5.0 2.0 -- --


-7 88 100
High Paw Low Paw
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: Low Alarm name: SpO2 PR
High Paw Low Pressure
(Threshold Visible). (Threshold Visible). Set maximum and Set maximum and
minimum SpO2 minimum pulse rate
thresholds. Only thresholds. Only
active when SpO2 active when SpO2
module connected. module connected.

79
Ventilation - Invasive

14.8 Common warnings 14.9.1 Common alternate functions


(Conventional ventilation)
Warning: The ventilator must not be
connected to the patient during the basic set- Note: Alternative functions are only selected
up procedure. via the user preferences utility.
See “User preferences” on page 132.
Warning: Do not enter the “Standby” mode
when connected to a patient. No ventilation is 14.9.1.1 Manual breath or Inspiratory hold
delivered. If a inspiratory hold time has been set in the user
preferences the Manual Breath button is replaced
Warning: The user shall ensure that all the by the Inspiratory Hold button. Pressing the button
alarm thresholds are set to appropriate levels will initiate a breath up to the set inspiratory time.
depending on patient condition. (this maximum time can be set to either 5 or 10
seconds). Releasing the button will end the breath.
14.9 Common cautions The inspiratory hold will use the set PIP.
14.9.1.2 O2 Boost or O2 suction
Caution: The basic set-up routines described
in this chapter are only to allow the user (i.e. If this feature has been enabled the user can select
clinician/medical staff) to enter each mode in when required O2 Boost or O2 suction through the
a safe manner. O2 parameter control.
It is the responsibility of the user to set safe 14.9.2 Common alternate functions (High
ventilation parameters. The ventilation frequency ventilation)
parameters stated in this chapter are used
only to guide the user, if the user deems these 14.9.2.1 Sigh or Sigh hold
parameters unsuitable for the patient then If a Sigh hold time has been set in the user
appropriate parameters should be selected. preferences the Sigh button is replaced by the Sigh
Hold button. Pressing the button will initiate a Sigh
The ventilator may display the parameters as breath up to the set inspiratory time. (this maximum
set by the user through the user preferences. time can be set to either 5 or 10 seconds).
Releasing the button will end the breath. The
The parameters stated in this chapter should
inspiratory hold will use the set Sigh P.
never override the user choice of ventilator
settings. 14.9.2.2 O2 Boost or O2 suction
If this feature has been enabled the user can select
Caution: The flow sensor is a serviceable item when required O2 Boost or O2 suction through the
and may require cleaning during use.
O2 parameter control.

14.10 Ventilation without a flow sensor


When using the ventilator without a flow sensor the
following features will not be available.

VTV control

Alarm thresholds
Tidal volume (Vte) ...........High and low
Minute volume (Vmin) .....High and low
Leak (%) ..........................Maximum

Waveforms and loops


Flow, Volume

80
Ventilation - Non invasive

Ventilation - Non-invasive
“Non-invasive - Dual limb”
“nCPAP D” on page 82

“NIPPV D” on page 84

“NIPPV Tr.” on page 86

“nHFOV” on page 88

“Non-invasive - Single limb”


“nCPAP S” on page 90

“DuoPAP” on page 92

“O2 therapy” on page 94

81
Ventilation - Non invasive

15. Non-invasive - Dual limb


15.1 nCPAP D

Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.
Dual limb patient circuit.

RR backup
Press and hold
the control for 2
seconds to
Additional switch On/Off.
Parameters Press confirm to Rise time
Active for 120 acknowledge. Alters the Trigger sensitivity
seconds when (Default 40 BPM pressure wave Set the breath trigger sensitivity.
mode selected. when On) shape. The default is 50%.

RR Backup Rise time Trig Sens


Additional
Parameters

BPM Seconds %

Ti CPAP PIP O2
Manual
Breath

Seconds mbar mbar %

Manual breath Ti CPAP PIP O2


Inspiratory time Continuous Peak inspiratory Oxygen
The inspiration positive airway pressure in concentration
time in seconds. pressure in mbar. For delivered to
mbar manual and patient.
backup breaths.
Alternate Interactive controls Interactive controls Alternate
function A. The Ti control cannot be The CPAP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set CPAP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti
+

Auto O2

Note. The above values are shown at their


factory default settings.

82
Ventilation - Non invasive

nCPAP D RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
BPM too high
Apnoea
Set maximum
Apnoea time limit.
Can be set to Off
(See warning
below) (Thresholds O2 %
invisible) Set maximum
Alarm name: threshold.
Period between (Thresholds
patient effort invisible)
exceeds apnoea Alarm name:
limit O2 over set limit.
RR O2
(BPM) (%)


100 60
0 21


Apnoea
(seconds)

15
PIP CPAP SpO2 PR
(mbar) (mbar) (%) (min)



20 7.0 99 180
15.0 4.0 -- --


11 1 88 100
Warning: PIP CPAP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name:
use an PIP too high PEEP too high SpO2 PR
alternative (Threshold Visible) (Threshold Set maximum and Set maximum and
method of Low Alarm name: Invisible) minimum SpO2 minimum pulse rate
detecting an PIP too low Low Alarm name: thresholds. Only thresholds. Only
apnoeic (Threshold Pressure below low active when SpO2 active when SpO2
episode, with Invisible) threshold module connected. module connected.
the Apnoea (Threshold Visible)
alarm turned
“OFF”

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Ventilation - Non invasive

15.2 NIPPV D

Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.
Dual limb patient circuit.

Additional
Parameters Rise time
Active for 120 Alters the
seconds when pressure wave
mode selected. shape.

RR Backup Rise time


Additional
Parameters

Seconds

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar %

Manual breath RR Ti PEEP PIP O2


Respiratory rate Inspiratory Positive end Peak inspiratory Oxygen
in breath per time expiratory pressure in concentration
minute. The inspiration pressure in mbar. For delivered to
time in seconds. mbar. manual and patient.
backup breaths.
Alternate Interactive controls Interactive controls Alternate
function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the Alarm note
allowable Ti. 1. The Low PIP alarm is disabled if
C. The Rise time cannot be the difference between the PIP and
increased beyond the set Ti PEEP are set to 6mbar or less.
2. If the difference between the PIP +
and PEEP is more than 6 mbar then
the following applies
a. If RR is 50 BPM or more the
alarm would sound after 5 ventilator
cycle. Auto O2
b. If RR is less than 50 BPM the
alarm would sound after 2 ventilator
cycle.

Note. The above values are shown at their


factory default settings.

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Ventilation - Non invasive

NIPPV D
default alarm
thresholds

O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)


60
21

PIP PEEP SpO2 PR


(mbar) (mbar) (%) (min)



20 7.0 99 180
15.0 4.0 -- --


11 1 88 100
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high SpO2 PR
(Threshold Visible) (Threshold Set maximum and Set maximum and
Low Alarm name: Invisible) minimum SpO2 minimum pulse rate
PIP too low Low Alarm name: thresholds. Only thresholds. Only
(Threshold Pressure below low active when SpO2 active when SpO2
Invisible) threshold module connected. module connected.
(Threshold Visible)

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Ventilation - Non invasive

15.3 NIPPV Tr.

Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.
Dual limb patient circuit.

Additional
Parameters Rise time
Active for 120 Alters the Trigger sensitivity
seconds when pressure wave Set the breath trigger sensitivity.
mode selected. shape. The default is 50%.

RR Backup Rise time P Support Trig Sens


Additional
Parameters

Seconds mbar %

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar %

Manual breath RR Ti PEEP PIP O2


Respiratory rate Inspiratory Positive end Peak inspiratory Oxygen
in breath per time expiratory pressure in concentration
minute. The inspiration pressure in mbar. For delivered to
time in seconds. mbar manual and patient.
backup breaths.
Alternate Interactive controls Interactive controls Alternate
function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the Alarm note
allowable Ti. 1. The Low PIP alarm is disabled if
C. The Rise time cannot be the difference between the PIP and
increased beyond the set Ti PEEP are set to 6mbar or less.
2. If the difference between the PIP +
and PEEP is more than 6 mbar then
the following applies
a. If RR is 50 BPM or more the
alarm would sound after 5 ventilator
cycle. Auto O2
b. If RR is less than 50 BPM the
alarm would sound after 2 ventilator
cycle.

Note. The above values are shown at their


factory default settings.

86
Ventilation - Non invasive

NIPPV Tr. RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
BPM too high
Apnoea
Set max Apnoea
time limit. Set to Off
as default (See
warning below)
(Thresholds O2 %
invisible) Set maximum
Alarm name: threshold.
Period between (Thresholds
patient effort invisible)
exceeds apnoea Alarm name:
limit. O2 over set limit.
RR O2
(BPM) (%)


100 60
0 21


Apnoea
(seconds)

OFF
PIP PEEP SpO2 PR
(mbar) (mbar) (%) (min)



20 7.0 99 180
15.0 4.0 -- --


11 1 88 100
Warning: PIP PEEP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name:
use an PIP too high PEEP too high SpO2 PR
alternative (Threshold Visible) (Threshold Set maximum and Set maximum and
method of Low Alarm name: Invisible) minimum SpO2 minimum pulse rate
detecting an PIP too low Low Alarm name: thresholds. Only thresholds. Only
apnoeic (Threshold Pressure below low active when SpO2 active when SpO2
episode, with Invisible) threshold module connected. module connected.
the Apnoea (Threshold Visible)
alarm turned
“OFF”

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Ventilation - Non invasive

15.4 nHFOV

Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust and
Dual limb patient circuit. monitor the ventilation parameters.
Oscillation Interactive controls
Pause The sigh RR cannot be increased
The oscillations beyond the limit dictated by the set
can be paused sigh inspiratory time. The sigh
for 60 seconds inspiratory time cannot be increased
by pressing the beyond the limit set by the set sigh
oscillation RR.
paused button.
Press and hold Sigh RR
the control for 1 Press and hold
seconds to the control for 2
switch On/Off. seconds to
switch On/Off.
Press confirm to
acknowledge.
Additional (Default 30 BPM Sigh Ti Sigh P
Parameters when On). Sets Sets the Sets the
Active for 120 the respiratory inspiratory time inspiratory
seconds when rate for the sigh for the sigh pressure for the
mode selected. breaths. breath. sigh breath.

Oscillation
Pause

Sigh RR Sigh Ti P Support Sigh P


Additional
Parameters

BPM Seconds mbar

Frequency I:E MAP ΔP VTV O2

Sigh

Hz Ratio mbar mbar %

Sigh* Frequency I:E MAP ΔP O2


The sigh control HFO frequency Ratio for Mean airway Delta pressure Oxygen
will initiate a in Hertz (Hz) inspiration to pressure in in mbar. concentration
pause at the set expiration (1:1, mbar delivered to
Sigh Ti. 1:2 & 1:3) patient.
Alternate Interactive controls Interactive controls Alternate
function The Sigh Hold will use the user MAP and Sigh P function
Sigh hold preference set 5 or 10 second A. The MAP control will O2 Boost
pause. O2 suction
automatically start to increase the
Caution*: With the Sigh RR set to Off the Sigh Ti can Sigh P when it passes the set level
be set anywhere between 0.1 and 3 seconds for of Sigh P and the Sigh P will track
manual Sigh’s. When Sigh RR is subsequently the MAP.
turned on the Sigh Ti could be incompatible with the B. If the MAP is decreased the Sigh
set Sigh RR. The user will have to adjust the Sigh Ti P will remain at the new level. In this +
or the Sigh RR accordingly.
case the difference between MAP
and Sigh P can be greater than 15
mbar.
C. The Sigh P cannot be decreased Auto O2
below the set MAP.
D. The Sigh P can be increased
independently of the set MAP but
only 15 mbar above the set MAP.
Note. The above values are shown at their factory
default settings.

88
Ventilation - Non invasive

nHFOV
default alarm
thresholds

O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)


60
21

Paw Paw SpO2 PR


(mbar) (mbar) (%) (min)



17 99 180
5.0 2.0 -- --


-7 88 100
High Paw Low Paw
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: Low Alarm name:
High Paw Low Pressure SpO2 PR
(Threshold Visible) (Threshold Visible) Set maximum and Set maximum and
minimum SpO2 minimum pulse rate
thresholds. Only thresholds. Only
active when SpO2 active when SpO2
module connected. module connected.

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Ventilation - Non invasive

16. Non-invasive - Single limb


16.1 nCPAP S

Mode type: Non-Invasive Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.
Single limb patient circuit.

RR backup
Press and hold
the control for 2
seconds to
Additional switch On/Off.
Parameters Press confirm to
Active for 120 acknowledge. Trigger sensitivity
seconds when (Default 10 BPM Set the breath trigger sensitivity.
mode selected. when On) The default is 50%.

RR Backup Rise time Trig Sens


Additional
Parameters

BPM Seconds %

Ti CPAP PIP O2
Manual
Breath

Seconds mbar mbar %

Manual breath Ti CPAP PIP O2


Inspiratory Continuous Peak inspiratory Oxygen
time positive airway pressure in concentration
The inspiration pressure in mbar. For delivered to
time in seconds. mbar manual and patient.
backup breaths.
Alternate Interactive controls Interactive controls Alternate
function A. The Ti control cannot be The CPAP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The
O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set CPAP.
cannot be increased beyond the
allowable Ti.

Auto O2

Warning: When using Small or Extra Small Note. The above values are shown at their
nasal prongs during CPAP, the Ventilator may factory default settings.
not raise an alarm if a patient disconnection
occurs. It is recommended that back-up
breaths are always turned on as this will Note: Application of the prongs/mask are not
deliver back up breaths and alert the user to a covered in this manual. Please refer to the
low PIP condition if the nasal prongs become instruction for use supplied with the nCPAP
detached. Only the monitoring of SpO2, or of generator.
transcutaneous Oxygen and Carbon Dioxide
will dependably alert the medical team to a
patient disconnection.

90
Ventilation - Non invasive

nCPAP S RR
Set maximum
default alarm threshold.
thresholds (Thresholds
invisible)
Alarm name:
BPM too high
Apnoea
Set maximum
Apnoea time limit.
Can be set to Off
(See warning
below) (Thresholds O2 %
invisible) Set maximum
Alarm name: threshold.
Period between (Thresholds
patient effort invisible)
exceeds apnoea Alarm name:
limit O2 over set limit.
RR O2
(BPM) (%)


100 60
0 21


Apnoea
(seconds)

15
PIP CPAP SpO2 PR
(mbar) (mbar) (%) (min)



15 9 99 180
15.0 4.0 -- --


8 1 88 100
Warning: PIP CPAP
Ventilation with Set maximum and Set maximum and
the Apnoea minimum minimum
alarm “OFF” thresholds. thresholds.
The user must High Alarm name: High Alarm name:
use an PIP too high PEEP too high SpO2 PR
alternative (Threshold Visible) (Threshold Set maximum and Set maximum and
method of Low Alarm name: Invisible) minimum SpO2 minimum pulse rate
detecting an PIP too low Low Alarm name: thresholds. Only thresholds. Only
apnoeic (Threshold Pressure below low active when SpO2 active when SpO2
episode, with Invisible) threshold module connected. module connected.
the Apnoea (Threshold Visible)
alarm turned
“OFF”

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Ventilation - Non invasive

16.2 DuoPAP

Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.
Single limb patient circuit.

RR Backup Rise time P Support


Additional
Parameters

Seconds mbar %

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar %

Manual breath RR Ti PEEP PIP O2


Respiratory rate Inspiratory Positive end Peak inspiratory Oxygen
in breath per time expiratory pressure in concentration
minute. The inspiration pressure in mbar. For delivered to
time in seconds. mbar manual and patient.
backup breaths.
Alternate Interactive controls Interactive controls Alternate
function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost
backup rate. PIP cannot be decreased below the O2 suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.

Auto O2

Note. The above values are shown at their


factory default settings.

Note: Application of the prongs/mask are not


covered in this manual. Please refer to the
instruction for use supplied with the nCPAP
generator.

92
Ventilation - Non invasive

DuoPAP
default alarm
thresholds

O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)


60
21

PIP PEEP SpO2 PR


(mbar) (mbar) (%) (min)



20 7.0 99 180
15.0 4.0 -- --


11 1 88 100
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high SpO2 PR
(Threshold Visible) (Threshold Set maximum and Set maximum and
Low Alarm name: Invisible) minimum SpO2 minimum pulse rate
PIP too low Low Alarm name: thresholds. Only thresholds. Only
(Threshold Pressure below low active when SpO2 active when SpO2
Invisible) threshold module connected. module connected.
(Threshold Visible)

93
Ventilation - Non invasive

16.3 O2 therapy

Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust and monitor the
ventilation parameters.
Single limb patient circuit.

Flow O2

mbar l/min %

Flow O2
Set the flow in Oxygen
l/min concentration
delivered to
patient.
Alternate
function
O2 Boost
O2 suction

Auto O2

Note. The above values are shown at their


factory default settings.

Note: O2 therapy has no alarms thresholds


when used without the SpO2 module

Note: O2 therapy mode displays the O2 (%)


trend by default.

Note: The O2 (%) trend will not display any


reading during the automatic oxygen
calibration routine.

94
Ventilation - Non invasive

O2 Therapy
default alarm
thresholds

O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)


60
21

SpO2 PR
(%) (min)



99 180
-- --


88 100

SpO2 PR
Set maximum and Set maximum and
minimum SpO2 minimum pulse rate
thresholds. Only thresholds. Only
active when SpO2 active when SpO2
module connected. module connected.

95
Ventilation - Non invasive

16.4 Common warnings


Warning: The ventilator must not be
connected to the patient during the basic set-
up procedure.

Warning: Do not enter the “Standby” mode


when connected to a patient. No ventilation is
delivered.

Warning: The user shall ensure that all the


alarm thresholds are set to appropriate levels
depending on patient condition.

16.5 Common cautions


Caution.The basic set-up routines described
in this chapter are only to allow the user (i.e.
clinician/medical staff) to enter each mode in
a safe manner.
It is the responsibility of the user to set safe
ventilation parameters. The ventilation
parameters stated in this chapter are used
only to guide the user, if the user deems these
parameters unsuitable for the patient then
appropriate parameters should be selected.
The ventilator may display the parameters as
set by the user through the user preferences.
The parameters stated in this chapter should
never override the user choice of ventilator
settings.

16.6 Common note


Note: All non-invasive modes are used
without a flow sensor. If the flow sensor is
connected please disconnect it prior to set
up.

96
SpO2 & etCO2 Sensors

SpO2 and etCO2 monitoring

“SpO2 monitoring (Masimo SET)” on page 98

“EtCO2 monitoring (MicroPod™)” on page 104

97
SpO2 & etCO2 Sensors

17. SpO2 and etCO2 monitoring The Masimo SET pulse oximeter assumes that
arterio-venous shunting is highly variable and that
17.1 SpO2 monitoring (Masimo fluctuating absorbance by venous blood is the major
component of noise during the pulse. decomposes
SET) S(660) and S(905) into an arterial signal plus a
The pulse oximeter is to be operated by, noise component and calculates the ratio of the
or under the supervision of, qualified arterial signals without the noise:
personnel only. The manual, accessories,
directions for use, all precautionary S(660) = S1 + N1
information, and specifications should be read
before use. S(905) = S2 + N2

17.1.1 Principle of Operation R = S1/S2


The Masimo SET® pulse oximeter is based on three
principles: Again, R is the ratio of two arterial pulse-added
absorbance signals and its value is used to find the
1. Oxyhemoglobin and deoxyhemoglobin differ in saturation SpO2 in an empirically derived equation
their absorption of red and infrared light
into the oximeter’s software. The values in the
(spectrophotometry).
empirically derived equation are based upon human
2. The volume of arterial blood in tissue and the light blood studies against a laboratory co-oximeter on
absorbed by the blood changes during the pulse healthy adult volunteers in induced hypoxia studies.
The above equations are combined and a noise
(plethysmography).
reference (N’) is determined:
3. Arterio-venous shunting is highly variable and
that fluctuating absorbance by venous blood is a N’ = S(660) - S(905) x R
major component of noise during the pulse.
If there is no noise N’ = 0: then S(660) = S(905) x R
The Masimo SET pulse oximeter as well as
which is the same relationship for the traditional
traditional pulse oximetry determines SpO2 by
pulse oximeter.
passing red and infrared light into a capillary bed
and measuring changes in light absorption during The equation for the noise reference is based on the
the pulsatile cycle. Red and infrared light-emitting value of R, the value being seeked to determine the
diodes (LEDs) in oximetry sensors serve as the light SpO2. The software sweeps through possible
sources, a photodiode serves as the photodetector.
values of R that correspond to SpO2 values
Traditional pulse oximetry assumes that all between 1% and 100% and generates an N’ value
pulsations in the light absorbance signal are caused for each of these R-values.
by oscillations in the arterial blood volume. This The S(660) and S(905) signals are processed with
assumes that the blood flow in the region of the each possible N’ noise reference through an
sensor passes entirely through the capillary bed adaptive correlation canceler (ACC) which yields an
rather than through any arterio-venous shunts. The output power for each possible value of R (i.e., each
traditional pulse oximeter calculates the ratio of possible SpO2 from 1% to 100%). The result is a
pulsatile absorbance (AC) to the mean absorbance Discrete Saturation Transform (DST™) plot of
(DC) at each of two wavelengths, 660 nm and 905 relative output power versus possible SpO2 value as
nm: shown in the following figure where R corresponds
S(660) = AC(660)/DC(660) to SpO2 = 97%:
S(905) = AC(905)/DC(905)

The oximeter then calculates the ratio of these two


arterial pulse-added absorbance signals:

R = S(660)/S(905)

This value of R is used to find the saturation SpO2 in


a look-up table built into the oximeter’s software.
The values in the look-up table are based upon
human blood studies against a laboratory co-
oximeter on healthy adult volunteers in induced
hypoxia studies.

98
SpO2 & etCO2 Sensors

17.2 Masimo SET® Connection 17.2.4 Sensor application sites


Site Selection
17.2.1 Connection to ventilator Always choose a site that is well perfused and will
Insert the Medi snap connector of the Oximetry completely cover the sensor's detector window. Site
Cable into the SpO2 socket on the rear of the should be cleaned of debris and dry prior to sensor
ventilator.(Red socket). placement.

NeoPt-3 Preterm Sensors


< 1 kg The preferred site is the foot. Alternatively,
across the palm and back of the hand can be used.
Neo-3 Neonatal/Adult Sensors
< 3 kg The preferred site is the foot. Alternatively,
across the palm and back of the hand can be used.
> 40 kg The preferred site is the middle or ring finger
of non-dominant hand.
lnf-3 Infant Sensors
3-20 kg The preferred site is the great toe.
Alternatively, the toe next to the great toe, or the
thumb can be used.
Pdtx-3 Paediatric
17.2.2 Disconnection 10-50 kg The preferred site is the middle or ring
The sensor cable can be disconnected at anytime. finger of non dominant hand.
The monitoring function can be turned OFF before
or after disconnection in the sensor panel or the Caution: The ventilator intended use is for for
user can press “Continue without SpO2” button in premature neonates greater than 0.3kg, term
the alarm message bar. neonates and infants, as well as paediatric
patients up to 30kg depending on condition.
17.2.3 Selection of Masimo SET® Sensors
The ventilator is currently designed to be used with 17.2.5 Connection of a sensor
the following 3 sensors. Firmly insert the 9-pin sensor connector to the
Oximetry Cable 9-pin receptacle shroud.
Masimo NeoPt-3
SLE P/Nº: LSP02/2321

Masimo Neo-3
SLE P/Nº: LSP02/2320

Masimo Inf-3
SLE P/Nº: LSP02/2319

Masimo Pdtx-3
Only available from Masimo Corp.

Caution. Please refer to the instruction for Rotate the clear latch over the mated connector until
use supplied with the sensors for size it snaps into place.
selection and application.

17.2.6 Disconnection
To disconnect the sensor, reverse the above steps.

99
SpO2 & etCO2 Sensors

17.3 Configuration 17.3.4 Alarm Delay


Select the utilities panel, this will now show the User Selectable Settings (seconds):
sensor tab then select the SpO2 button. 0
5
10 (Default)
15

17.3.5 Auto O2: SpO2 Target range alarm limits.


This option allows the user to pre select one of four
pre defined target ranges high and low alarm limits
for OxyGenie®.
90-94%
91-95% (Default1)
92-96%
94-98%
17.3.1 SpO2 monitoring ON/OFF For normal SpO2 monitoring the alarm limits are set
This button will turn the SpO2 monitoring function at 99%2 for the high and 88%2 for the low.
ON or OFF. 1
The default can be user set to any of the four
Note: This does not turn OFF the sensor. ranges via user preferences. See “Parameters tab”
When OFF, the displayed SpO2 value, trend on page 266.
and associated alarms are disabled. 2The
default high and low values can be use via set
user preferences. See “Alarms tab” on page 267.
17.3.2 FastSat™
17.3.6 SpO2 Sensitivity
FastSatTM enables rapid response to, and display
of, fast changes in SpO2 by giving priority to the The sensitivity mode setting allows the clinician to
most recent data. adapt the SpO2 measurement sensitivity to the
patient’s level of SpO2 signal strength and quality at
Caution. FastSatTM is not recommended for
the measurement site.
routine use as there may be an increase of the
frequency of alarms caused by rapid,
Normal Sensitivity is the recommended for
transitory SpO2 changes.
patients who are experiencing some compromise in
blood flow or perfusion. It is advisable for care areas
17.3.3 Averaging Time where patients are observed frequently, such as the
The user-selectable averaging feature allows the intensive care unit (ICU).
clinician to select the desired level of visibility to
subtle variations in the measured value. APOD (Adaptive Probe Off Detection) APOD
Sensitivity is the recommended sensitivity mode
*2-4 seconds where there is a high probability of the sensor
becoming detached. It is also the suggested mode
4-6 seconds
for care areas where patients are not visually
8 (Default) seconds monitored continuously. This mode delivers
enhanced protection against erroneous pulse rate
10 seconds
and arterial oxygen saturation readings when a
12 seconds sensor becomes inadvertently detached from a
patient due to excessive movement.
14 seconds
16 seconds. Maximum Sensitivity (MAX) is recommended for
use on patients with weak signals (e.g. high ambient
*The averaging time is fixed to 2-4 seconds when
noise and/or patients with very low perfusion) and
OxyGenie® is on.
for use during procedures or when clinician and
patient contact is continuous such as in higher
acuity settings.

100
SpO2 & etCO2 Sensors

17.3.7 Rapid Desat 17.6 SpO2 Waveform and display


The Rapid Desat Alarm is a user-selectable setting options
to allow a clinician to tell the monitor to override the
The SLE6000 displays the Pleth (Plethysmograph)
audible alarm delay when the SpO2 value exceeds
waveform and the SIQ (Signal Identification and
the alarm limit threshold by a user-selectable % Quality) indicator waveform.
User Selectable Settings:
5% (Default)
10%
Off

17.3.8 Perf Index


This button will turn the Perfusion Index function ON
or OFF in the waveform window. The Pleth waveform is displayed in the real time.
Perfusion Index is a value that indicates arterial
pulse signal strength as the percentage of pulsatile This SIQ indicator waveform shows the acquired
signal to non-pulsatile signal. measurement confidence and timing of each
detected pulse relative to the Pleth. The ventilator
displays the indicator waveform as a vertical line.
The taller the line the better the signal quality, as the
17.4 Monitored values quality drops the line decreases in height.
SpO2 in percent will be displayed in the bottom The quality is also indicated by a good quality signal
section of the monitored values panel. Circled in the being coloured blue and a poor quality signal being
above illustration. coloured orange.

PR (Pulse rate) is displayed in the top right of the The SIQ indicator waveform is not normalized.
SpO2 waveform.
Also displayed is the Pulse Rate PR and Perfusion
PI (Perfusion Index) when turned On will appear index PI. The Pulse rate is always displayed but the
next to PR value. Perfusion Index is only displayed when turned on
from the SpO2 sensor panel.

17.5 SpO2 alarms thresholds


When SpO2 monitoring is turned on the following
two high and low alarm thresholds become active in
the Alarm Limits panel.

SpO2% and PR (/min).

For SpO2 the user has a choice of two layouts.

Layout 1: “Waveforms” which is standard three


ventilation waveforms Pressure, Flow & Volume
with the addition of SpO2

Layout 2: "SpO2" which is one ventilation waveform


(Pressure, Flow or Volume) plus Pleth/SIQ SpO2
and Set O2.

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SpO2 & etCO2 Sensors

17.7 Standard Waveform display option 17.8 SpO2Waveform display option


From the Layout panel select Waveforms. From the Layout panel select SpO2..

Turn ON the SpO2 waveform.

The user can directly confirm the selection without


editing the SpO2 waveform preferences.
This will add a fourth Pleth/SIQ waveform to the
bottom of the waveforms in a ventilation mode.

If the user presses "Edit" button the “SpO2 Screen”


panel becomes active.

17.7.0.1 SpO2 and etCO2 dual waveform display


If the SpO2 and etCO2 sensors are connected at the
same time and both the waveforms have been
selected for display, the bottom waveform will be
divided in two. The left area for SpO2 and the right
area for etCO2.

The “SpO2 Screen” panel allows the user to select


which ventilator waveform is displayed at the top of
the screen and the time base for the trends.

The default waveforms and trends are:

Waveform ... Pressure*


Waveform ... Pleth
Trend .......... SpO2
Trend .......... Set O2

*The user can choose to display Pressure, Flow or


Volume.

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SpO2 & etCO2 Sensors

Pressing the confirm button will activate the SpO2 17.8.1 SpO2 Waveform in O2 therapy
layout. With SpO2 monitoring turned on the user can select
either the three waveforms from the “SpO2” panel
Pleth, SpO2 and Set O2 or two larger waveforms

 
1 Pleth and O2 by selecting the "Trends" panel.

2 17.9 SpO2 module testing


To test the functionality of the SpO2 module please
3 follow the instructions in section ’40.1 Masimo
SET®’ on page 256.
4
17.10 Operation during mains power
interruption (Mains power fail)
The SpO2 operation and monitoring is not affected
when ventilator mains power is interrupted.
1. Standard Pressure/Flow/Volume waveform.
Shows the one of the user selected waveforms.
Pressure waveform being the default.

2. Pleth/SIQ waveform
Shows the Pleth waveform (Upper trace) and the
signal quality indicator (SIQ) (Lower trace).
3. SpO2 trend.

Shows the SpO2 trend. The SpO2 trend has two


alarm thresholds. The SpO2 trend alarms thresholds
can be manually adjusted via the alarm panel, the
defaults are upper 98% and lower 88%. The limits
can be set to other values through user preference,
see section ’42.1.3 Alarms tab’ on page 267.
Note: Gaps can appear in the SpO2 trend due
to loss of signal.

4. Set O2% trend.

Shows the Set O2%

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SpO2 & etCO2 Sensors

17.11 EtCO2 monitoring (MicroPod™) 17.11.4 Disconnection


The sensor module can be disconnected at
17.11.1 Principle of Operation anytime. The monitoring function can be turned
The capnography module is intended to OFF before or after disconnection in the Sensor
provide professionally trained health care panel or the user can press “Continue without
providers with continuous, non-invasive etCO2” button in the alarm message bar.
measurement and monitoring of carbon
Note: When disconnecting a sampling line
dioxide concentration of the expired and inspired
from the device, hold the CO2 input
breath and respiration rate. It is intended for use
connector door open while removing the
with neonatal, pediatric, and adult patients in
sampling line, to avoid catching the sampling
hospitals, hospital-type facilities.
line on the connector door.
17.11.2 Connection to ventilator
Insert the Medi snap connector of the MicroPod™ 17.11.5 Mounting of module
Cable into the etCO2/CO2 socket on the rear of the CO2
ventilator.

This cable serves for both data communication and


power supply, with the module receiving power from Note: The MicroPod™ should be mounted
the monitor through this connection. A separate with the CO2 connector facing upwards or to
power source is not required.
the side to avoid ingress of water into the
exhaust port when the MicroPod™ is not in
A LED on the MicroPod™ will indicate functioning,
operation.
as follows:
• During startup the LED will blink slowly
• During normal operation the LED will remain on
continuously
• During a communication failure, malfunction, or
disconnection of the MicroPod™, the LED will be
off.

17.11.3 Initialization Time


The time before CO2 measurements are available
from the MicroPod™ to the ventilator includes
power-up time and initialization time. The
initialization time includes module initialization and
self tests.
Power-up time: Maximum 10 sec
Initialization time: Typically 30 seconds, maximum
180 seconds.

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SpO2 & etCO2 Sensors

17.11.6 Connection of a FilterLine™ 17.12 Configuration


Once configuration is complete, a patient can be Select the utilities panel, this will now show the
connected to the MicroPod™ for CO2 monitoring, as sensor tab then select the etCO2 button.
follows:

1. Slide open the CO2 input connector shutter and


connect the appropriate sampling line. Screw the
sampling line connector into the monitor clockwise
until it can no longer be turned.

17.12.1 EtCO2 Monitoring


This button will turn the etCO2 monitoring function
2. Connect the sampling line connector to the
ON or OFF.
patient circuit as shown below. When the sampling
line is connected, the MicroPod™ will immediately Note: This does not turn OFF the sensor.
begin to search for breaths, but it will not indicate a When OFF the displayed etCO2 value, trend
No Breath condition before any valid breaths have and associated alarms are disabled.
occurred.
17.12.2 Pump control
This will turn the MicroPod™ pump ON or OFF.

17.12.3 Breath absence alarm time


This will set the time trigger for the “No etCO2
Breath” Alarm. The range is from 10-60 seconds.
The default is 20 seconds

17.12.4 Device information


The panel also displays device information.

Software version of the MicroPod™.


Hardware version of the MicroPod™.
Device serial number.
Last Calibration date..
Next Calibration due date.
Next service due..
3. CO2 data will now be provided to the host monitor Note: See SLE6000 Service manual for
for display. The host monitor may also display IPI service information and calibration
data, if configured to do so. instructions.
4. All MicroPod™ messages and alarms are
controlled and displayed on the host monitor.

105
SpO2 & etCO2 Sensors

17.13 Waveforms 17.16 Flow measurement compensation


From the Layout panel select Waveforms. when using side stream etCO2
monitoring.
The patient flow sensor will compensate for the side
stream sample flow by adjusting patient flow
measurements when the etCO2 monitor pump is on
and etCO2 is detected. If the monitor pump is off or
etCO2 is not detected then no flow measurement
compensation is made.

Turn ON the etCO2 waveform.


17.17 EtCO2module testing
To test the functionality of the etCO2 module please
follow the instructions in section ’40.2 MicroPod™’
on page 257.

Press the confirm button. 17.18 Operational notes related to etCO2


This will add a fourth etCO2 waveform to the bottom monitoring using MicroPod™
of the waveforms in a ventilation mode.

Note: During nebulization or suction for


Intubated patients, in order to avoid moisture
buildup and sampling line occlusion, remove
the sampling line luer connector from the
module.

Note: Replace the sampling line according to


17.13.0.1 EtCO2 and SpO2 dual waveform display hospital protocol or when a blockage is
If the etCO2 and SpO2 sensors are connected at the indicated by the host monitor screen.
Excessive patient secretions or a build-up of
same time and both the waveforms have been
selected for display, the bottom waveform will be liquids in the airway tubing may occlude the
divided in two. The left area for SpO2 and the right sampling line, requiring more frequent
area for etCO2. replacement.

17.14 Monitored values Note: When connecting a sampling line to the


etCO2 in the selected units will be displayed in the module, screw the sampling line connecter
bottom section of the monitored values panel. clockwise into the module CO2 port until it
Circled in the above illustration. can no longer be turned, to ensure that it is
connected securely to the module. This will
17.15 EtCO2 alarms thresholds
assure that there is no leak of gases during
When etCO2 monitoring is turned on the following measurement at the connection point and
alarm threshold becomes active in the Alarm Limits that measurement accuracy is not
become active. compromised.

etCO2

106
SpO2 & etCO2 Sensors

Note: When the “Replace etCO2 filterline”


message appears on the screen, indicating
that the FilterLine™ which is attached to the
module is blocked, the module’s CO2 pump
will stop pumping the patient’s breath into the
module for testing. Follow the instructions
that appear in the Troubleshooting section of
this manual: First disconnect and reconnect
the FilterLine™. If the message still appears,
disconnect and replace the FilterLine™. Once
a working FilterLine™ is attached to the
module, the pump will automatically resume
operation.

Note: Following connection of the CO2


sampling line to the monitor and to the
patient, check that CO2 values appear on the
host monitor display.

Note: Sampling lines with H in their names


include a moisture reduction component
(Nafion® or its equivalent) for use in higher
humidity environments where long duration
use of CO2 sampling is required.

Note: All Biocompatibility Reports for the


sampling lines are kept in Oridion (Covidien
Jerusalem) AGILE PLM system, doc #
DR0025, and will be available upon request.

17.19 Operation during mains power


interruption (Mains power fail)
The etCO2 operation and monitoring is not affected
when ventilator mains power is interrupted.

17.20 Cleaning the MicroPod™


Enclosure
The following list of materials had been tested and
approved to be used for cleaning the MicroPod™
enclosure: water and soaps, dilution of ammonia
<3%, ethanol 70%, isopropanol 70%, and Incidur
spray. The cleaning should be performed by wiping
the MicroPod™ with a cloth moistened with any of
these materials.

107
SpO2 & etCO2 Sensors

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108
OxyGenie®

OxyGenie®

109
OxyGenie®

18. OxyGenie® SpO2 monitoring is obtained via Masimo SET


sensors. High and low SpO2 alarms are
Warning: Use of OxyGenie® is
automatically set to 1% above the upper end of the
contraindicated on patients whose target
target range and 1% below the lower end of the
SpO2 is outside the following target ranges.
target range. These limits are user adjustable.
90-94%, 91-95%, 92-96%, 94-98%.
See SLE uSpO2 Pulse Oximetry Cable (Masimo
SET) IFU for details of conditions which may affect
Caution: Before initiating (or re initiating)
the accuracy of SpO2 readings.
OxyGenie, check (and adjust if necessary)
that the O2 setting is appropriate for the Caution: Additional ventilator independent
patients current clinical condition. This initial patient monitoring (bedside vital monitoring
O2 setting optimises the initial response and blood gas analyser) should be performed.
initial response time of the algorithm.
Warning: Do not use OxyGenie® if the
18.1 Introduction difference between SpO2 and SaO2 is greater
The OxyGenie® system is intended to control the than 5%.
inspired oxygen delivery, to keep the SpO2 of the
patient within a predefined range of SpO2, during OxyGenie® can be used in any mode of ventilation.
mechanical ventilation, nCPAP, Non Invasive
Respiratory support and High Flow Oxygen Therapy 18.1.1 OxyGenie® modes of operation
administered to Neonatal, Infant and Paediatric
18.1.1.1 Auto mode
patients.
OxyGenie® calculates the patients oxygen
The OxyGenie® algorithm is a closed loop requirement from the current and previous SpO2
proportional-integral-derivative (PID) controller.
values every second and adjusts the oxygen
Once a second this algorithm uses the patient’s
blender setting accordingly.
SpO2 (measured using Masimo SET sensors) to
calculate the appropriate O2 setting to maintain When OxyGenie® is in “Auto” mode the status
indication box and the O2 Control shows “Auto” .
SpO2 within the target range.
When OxyGenie® is active the O2 control button
OxyGenie® calculates the average amount of
shows the instantaneous O2 value being sent to the
oxygen required to keep the patient within the target
blender. The monitored O2 will show the O2
range. This is calculated using 1 hours data and this
value is called the “Reference O2”. measured by the oxygen cell. A slight difference in
these values is normal

Note: the “Reference O2” value is an average 18.1.1.2 Fallback mode:


of the patient’s oxygen requirement for the OxyGenie® will go into “fallback mode” when no
last hour. valid SpO2 signal is received. This can occur if the
SpO2 sensor gets detached from the patient or does
not make good contact with the skin, or if a low SIQ
The OxyGenie® will is reported by the Masimo system.
not set the O2 to
RR Sp (/min) SpO2 (%)
more than 40% When OxyGenie®
above or below the is in “Fallback”
Vmin % Sp
reference O2, to mode the status RR Sp (/min) SpO2 (%)

avoid large O2 indication box show


fluctuations in Vmin % Sp
Δ FiO2 Max “waiting for signal”
delivered oxygen. Auto and the “O2” O2
The reference O2 Control shows Waiting for
value used for the
above function is
“- - -”
--- Signal

capped at 60% so that the OxyGenie® can always


reduce the O2 to 21% when required.

110
OxyGenie®

18.1.1.3 Manual override 18.2.2 Activating OxyGenie®


At any time when OxyGenie® is switched on the
user can make manual adjustments to the set O2, Note: OxyGenie® is only available when the
the manually set O2 will be delivered for 30 seconds SpO2 sensor is connected and SpO2
monitoring is turned on.
When OxyGenie® is in “manual override” mode the
status indication box show “manual override” and To activate OxyGenie® press and hold O2
the “O2” Control shows “- - -” the “O2” parameter control for 3
seconds.
18.1.1.4 Inactive mode
When OxyGenie® is not active the status indication
box will not be visible.
Press the
18.2 OxyGenie® Fall back mode O2
OxyGenie® button.
Operation of the Fall back mode is as follows.

First 60 seconds of no valid SpO2 signal: By pressing the


OxyGenie® will deliver the last O2 setting. confirm button
OxyGenie® will
After 60 seconds of no valid SpO2 signal become active.
If the last valid SpO2 reading was within the target
range the OxyGenie® will continue to deliver the last
set O2 value. This is indicated by O2
the status
If the last valid SpO2 reading was above the target indication message Auto
Auto
range OxyGenie® will slowly decrease the delivered box next to the O2
oxygen towards the reference O2 value. parameter control.
If the last valid SpO2 reading was below the target
range OxyGenie® will slowly increase The concentration of O2 will now be automatically
the delivered oxygen towards the reference O2
controlled to maintain the target SpO2 range.
value
18.2.3 Deactivating OxyGenie®
After SpO2 signal has been restored
As soon as a valid SpO2 signal is received To deactivate OxyGenie® press and
hold the O2 parameter control for 3
OxyGenie® will calculate and set the oxygen seconds.
requirement based on that SpO2 value. Auto

During “Fallback mode” the “O2” control button will Then press the O2
show “---“ in place of “Auto” and the OxyGenie® OxyGenie® button.
status indication will show “waiting for signal”

SpO2 alarms and exception messages will show in By pressing the


the alarms bar. confirm button
OxyGenie® will
18.2.1 Checking the OxyGenie® response become inactive.
The response of the OxyGenie® to changes in SpO2
can be seen in the set O2 shown in the O2 control
button and also in the O2 trend.
The O2 parameter control returns to O2
normal.

111
OxyGenie®

18.2.4 Activating manual override 18.3 SpO2Waveform display option and


Caution: Manual override cannot be cancelled OxyGenie®
once initiated. Pressing the confirm button will activate the SpO2
layout.
To modify the O2 O2
concentration
manually just touch Auto

  
the “O2” control.
Auto 1

2
The message box will be
replaced by the plus/minus
buttons. The text "Auto" will be
3
replaced by three dashes. ---
4
Adjust the O2% to O2
the required
percentage.
--- 1. Standard Pressure/Flow/Volume waveform.
Shows the one of the user selected waveforms.
On pressing the Pressure waveform being the default.
O2
confirm button the 2. Pleth/SIQ waveform
30 second manual Manual override
override will start. --- (30s) Shows the Pleth waveform (Upper trace) and the
This is indicated by signal quality indicator (SIQ) (Lower trace).
message box 3. SpO2 trend.
turning blue and displaying the text “Manual
Override” with the remaining seconds being
displayed underneath.

18.2.5 Changing the SpO2 target range


The SpO2 target range can be changed by the user
at any time. To change the target range, the user
must navigate “Utlillites”>”Sensors” then select the Shows the SpO2 trend and the SpO2 target range
“SpO2” button. The available SpO2 target ranges indicated by the blue bar. The target range is flanked
can be selected from the relevant drop list. by the two alarm thresholds which are automatically
On pressing confirm the target range will change to set to.±1% either side of the selected target range.
that selected. The SpO2 trend alarms thresholds can be manually
adjusted via the alarm panel.
18.2.6 Averaging Time Note: Gaps can appear in the SpO2 trend due
The averaging time is fixed to 2-4 seconds when to loss of signal.
OxyGenie® is on.
4. Set O2% trend.

Shows the Set O2% and the reference O2%


indicated by the dashed line. Also active is the High
O2% alarm threshold.

112
OxyGenie®

18.4 OxyGenie® and O2 Boost

Note. O2 Boost is disabled when OxyGenie®


is on.

To use O2 boost first disable OxyGenie®. For more


information on O2 boost See “O2 Boost” on
page 119.

18.5 OxyGenie® and O2 Suction

Note. O2 Suction is disabled when OxyGenie®


is on.

To use O2 Suction first disable OxyGenie®. For


more information on O2 Suction See “O2 Suction”
on page 118.

113
OxyGenie®

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114
Operational features

Operational features

115
Operational features

19. Operational features On cancelling the medium Priority “Battery Low”


alarm the following new icon will appear above the
19.1 General battery icon.

19.1.1 Standby Mode


Warning: Do not enter the “Standby” mode
when connected to a patient. No ventilation is
This indicates that the medium priority “Battery Low”
delivered.
alarm is inhibited.

19.1.2 Apnoea alarm set to “Off” The battery charge % status will continue to display
the percentage below the new icon until the high
In any mode where the user can set the Apnoea
priority “Battery Low” alarm is triggered indicating 10
alarm to “Off” the backup breaths are disabled even
minutes of battery life remaining.
when turned “On” unless apnoea is reinstated.
The triggering of the high priority “Battery Low”
Warning: The user must use an alternative alarm removes the “Low Battery alarm inhibit icon”.
method of detecting an apnoeic episode, Once all battery power has been exhausted the
whether ventilating invasively or non complete power fail alarm will sound and the
invasively with the Apnoea alarm turned ventilator will cease to operate.
“OFF”.
Warning. The ventilator can be used with a
completely discharged battery, but a note
19.1.3 Reserve power source
must be taken that in the event of a mains
The ventilator will typically run for over 3 hours from power failure the ventilator will cease to
100% battery charge to complete discharge, both in ventilate the patient.
conventional and HFOV modes. Actual battery
discharge duration will depend on battery condition
Warning. Do not allow the batteries to remain
and ventilation settings applied. Please refer to the
in a deep discharged state. Recharge the
warning for actual safe operation times.
batteries as soon as possible to preserve
The operation of the ventilator does not change battery life. If the ventilator is to be placed in
when on the reserve power source. storage then ensure the batteries are fully
The operation of the ventilator does not change charged.
when charging the reserve power source.
The ventilator does not have to be turned on to 19.1.4 Parameter Memory
charge the batteries. During use the ventilator will The user should be aware that the ventilator will
keep the batteries fully charged. remember user parameter settings when switching
In the event of a mains power failure a “Main Power between modes. Though when the setting is
Fail” alarm will sound and be displayed in the alarm remembered between ventilatory modes the
panel. The alarm is low priority. parameter title may change. An example is the
The user can suspend the “Main Power Fail” alarm CPAP parameter in CPAP mode becomes the
by pressing the Reset button when the “Main Power PEEP parameter in CMV mode.
Fail” alarm is present.
19.1.5 HFO variable I:E ratio (Only available with
HFOV and nHFOV options)
Warning: In a “Mains Power Fail” condition The variable I:E ratio allows the user to increase the
and if the user clears the “Mains Power Fail” expiratory phase in proportion to the inspiratory
alarm, the next power related alarm that will phase by the indicated ratio 1:2 or 1:3.
trigger will be the medium priority “Battery
Low” alarm. This indicates that the internal Warning: Inappropriate changes in the I:E
power source has reached 25% capacity. The ratio may result in a reduction of the volume
user shall remove the patient to an alternative for each HFO cycle and the subsequent
form of ventilation at this point if mains power minute volume delivered to the patient.
cannot be restored. If the user clears the Secondary monitoring of TcPO2 may be
medium priority “Mains Power Fail” alarm, required.
the next power related alarm that will trigger
will be the high priority “Battery Low” alarm.
This indicates that the internal power source
has a less than 10 minutes remaining battery
life.

116
Operational features

19.1.6 Pressure Support Breaths Not Delivered 19.1.8.2 Vte Target Resolution
as Set The tidal volume parameter control has three
There are a number of scenarios where the different resolutions.
ventilator may have difficulty in achieving the set
pressure on support breaths. From 2ml to 10ml the parameter increments in
Scenario 1 0.2ml steps (Fine resolution).
If the set support level is 5mbar or less above the From 10ml to 100ml the parameter increments in
PEEP with a short Ti time. 1ml steps (Standard resolution).
Scenario 2
If the patient lung is large or a large bore circuit is From 100ml to 300ml the parameter increments in
used. If the patient lung/circuit has a large 5ml steps (Coarse resolution).
compliance then it could have a large time constant
19.1.9 Max Ti in PSV
so regardless of what pressure the ventilator puts
out, it could take longer than the delivered Ti to rise In PSV mode the Ti parameter is marked Max Ti
to that pressure. because the termination sensitivity control (stop
support at %) can terminate the breath before the
19.1.7 Trigger sensitivity set inspiratory time is reached.
With a flow sensor fitted. 19.1.10 Suctioning (Closed suction).
The breath trigger sensitivity needs to be set in all
Closed suction catheters can be used in all invasive
patient interactive modes (default 0.6 ml).
modes. No special setting is required for the use of
Setting the breath trigger sensitivity at its most a closed suction catheter.
sensitive level (0.2ml) may allow the ventilator to
interpret background noise in the patient circuit as 19.1.11 VTV & HFOV
patient breathing, resulting in auto-triggering. Volume control is to be achieved by automatic
When the ventilator is used with a flow sensor the adjustment of the delta P, in a similar way to PIP
ventilator monitors gas flow to detect the patient being automatically controlled in conventional
breath. modes to maintain a fixed expiratory volume.
When the ventilator is used without a flow sensor There are significant differences (between HFOV +
the ventilator monitors pressure change to detect VTV and conventional VTV) as the volume is
the patient breath. updating much faster than it does in conventional
Without a flow sensor fitted. breath mode.
The breath trigger sensitivity needs to be set in all In conventional breath modes with VTV, a decision
patient interactive modes. Default 50%. to adjust the pressure is made whenever the
Setting the breath trigger sensitivity at its most expiratory volume is received from the monitor. This
sensitive level (100%) may allow the ventilator to is typically once per standard breath. In HFOV
interpret background noise in the patient circuit as expiratory volumes are updated once per cycle. The
patient breathing, resulting in auto-triggering. expiratory volumes are subject to large variations on
When the ventilator is used with a flow sensor the a cycle by cycle basis and are received up to 20
ventilator monitors gas flow to detect the patient times a second. Rather than make an adjustment on
breath. every cycle, they will be made on the average
When the ventilator is used without a flow sensor expiratory volume.
the ventilator monitors pressure change to detect As with conventional ventilation the Delta P “ΔP”
the patient breath. control message will become the “ΔP Max”.
19.1.8 Volume Targeted Ventilation, Vte (VTV) 19.1.11.1 Vte Target Resolution
19.1.8.1 Ti The tidal volume parameter control has two different
When VTV is set to ON in CPAP, CMV, PTV, PSV resolutions.
and SIMV, if the inspiratory volume exceeds a
From 2ml to 10ml the parameter increments in
safety limit, the breath is terminated, to prevent
0.2ml steps (Fine resolution).
over-distension of the lung. This will result in a lower
measured Ti than set. The actual inspiratory time is From 10ml to 50ml the parameter increments in 1ml
displayed in the lung mechanics and measurement steps (Standard resolution).
panel as Ti meas.

117
Operational features

19.2 Types of leak compensation 19.3 O2 Suction


19.2.1 VTV and patient leak Note: O2 suction is only available if activated
The ventilator will attempt to achieve the set VTV in user preferences. See “User preferences”
within the following limiters of Max PIP or 50% leak. on page 266.
or
The ventilator will increase the Max PIP to achieve
Caution. O2 Suction is disabled when Auto
the target volume and automatically compensate for
a leak of up to 50%. O2 is on. See “OxyGenie® and O2 Suction” on
page 113.
19.2.2 NIV modes and patient leak
The ventilator will increase the flow of the fresh gas The O2 suction feature allows the user to increase
in response to patient leak to a maximum of 15 l/min the delivered % of oxygen prior to, during and after
to maintain the CPAP/PEEP pressure set by the a suctioning procedure for a fixed time.
user.
To activate O2
O2 Suction
Suction press and
19.2.3 PSV mode automatic leak Compensation hold the O2
parameter control (+5% 3min)
If a large leak is present in the respiratory circuit, it for 3 seconds and
may prevent the flow from being terminated in PSV then press the O2
mode. If the leak flow is above the selected confirm button.
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 “O2 Suction in
Standby” message O2 Suction
at the leak flow level. If the termination level is in Standby
above the leak flow, the flow is terminated at the is displayed above
selected termination level. An algorithm would the O2 parameter
compensate for leak flows up to 5 l/min or 50% of control (the control
the peak flow whichever happens first. It is also is renamed “O2 O2 Suction
only active if the leak volume is between 10% to Suction”).
The plus/minus and
50%.
confirm button also
become active. %

The user if required can adjust the percentage


increase over the set at his point.

The colour of the ‘eyebrow’ bar of the O2 Suction


% O2 parameter control remains the
same for the part that represents the
original % O2 setting, but the colour
changes to red for the part that %
represents the O2 increase. The
example shows a set percentage of 30% with a
default boost of 5%.

Note: The default increase in O2 can be pre


set between 1 to 10% above the current
setting or 100%. The factory default is 5%.
See “User preferences” on page 266.

The user can increase or decrease the % O2, but it


cannot be reduced below the original set value.

118
Operational features

The user presses confirm button. This


O2 Pre
19.4 O2 Boost
action starts the O2 Suction Suction in
procedure. rogress Note: O2 Boost is only available if activated in
A message “O2 Pre Suction in user preferences. See “User preferences” on
Progress” message is displayed 2min 59s
page 266.
above the “O2 Suction” parameter O2 Suction
control for a countdown of 3 minutes.
Caution. O2 Boost is disabled when Auto O2
The ventilator waits for a
disconnection in the following 3 is on. See “OxyGenie® and O2 Boost” on
minutes. % page 113.

If the user doesn’t disconnect the patient during the The O2 Boost feature allow the user to increase the
3 minute window the boost will automatically finish. delivered % of oxygen to a preset or user set
increase for a maximum of two minutes.
When the user disconnects the
O2 Suction To activate O2
patient. The ventilator will display a in Progress O2 Boost
message “O2 Suction in Progress” Boost press and
and will start counting down for 2 hold the O2
minutes. 1min 59s parameter control (+5% 3min)
The alarm mute is automatically for 3 seconds and
O2 Suction
instated. then press the O2
During this time the ventilator waits for confirm button.
a re-connection. If the User doesn’t
reconnect the patient before the time %
is up, this will cause the ventilator to
alarm. The procedure stops at that
point. “O2 Boost in
Standby” message O2 Boost in
Standby
When the user reconnects the patient is displayed above
O2 Post
before the end of the 2 minute window the O2 parameter
Suction in
for suctioning, the ventilator starts a Progress control (the control
new 2 minute countdown, at the is renamed “O2 O2 Boost
elevated % O2. A message states 1min 59s Boost”).
“O2 Post Suction in Progress”. The plus/minus and
O2 Suction
confirm button also
become active. %
The procedure will stop at the end of
the 2 minute countdown.
%
Note: The default increase in O2 (Boost) can
be pre set between 1 to 10% above the current
If the user presses and holds the O2
O2 Suction setting or 100%. The factory default is 5%.
Suction parameter control at any time
a new control appears above the See “User preferences” on page 266.
message panel. If the user presses
Press to disable The colour of the ‘eyebrow’ bar of the O2 Boost
this control and confirms the action
% O2 parameter control remains the
the procedure is cancelled.The % O2
O2 Pre same for the part that represents the
returns to original value and message Suction in original % O2 setting, but the colour
clears. Progress
changes to red for the part that %
1min 59s represents the O2 increase. The
example show a set percentage of 30% with a
O2 Suction default boost of 5%.

The user can increase or decrease the % O2, but it


% cannot be reduced below the original set value.

119
Operational features

The user presses confirm button. This


O2 Boost in 19.5 Alarm thresholds
action starts the O2 boost procedure Progress
The ventilator for each mode has sets of pressure
related alarm thresholds that are set by the user or
A countdown timer is set for 2
1min 59s auto set by the ventilator around the user set
minutes. After 2 minutes the
parameters.
procedure stops. O2 Boost The only mode that does not have any pressure
related alarm thresholds is O2 therapy.

%
19.5.1 Alarm thresholds for conventional modes
(invasive and non invasive - dual limb).
The diagram below shows the pressure alarm
If the user presses and holds the O2
O2 Boost thresholds for conventional modes (invasive and
Boost parameter control a new control
non invasive).
appears above the message panel.
The user presses this control and
Press to disable
confirms the action the procedure is
cancelled.
O2 Boost in
Progress
The % O2 returns to original value
and message clears.
1min 59s

O2 boost

A. Zero pressure line


B. Waveform
Alarm thresholds
1. Low Pressure (Low PEEP alarm control)
Autoset and user adjustable.
2. High PIP (High PIP alarm control). Autoset and
user adjustable.
3. High pressure threshold exceeded (+5 mbar
above PIP). Autoset.
4. High pressure threshold exceeded (+20 mbar
above PIP) Autoset.
5. Sub ambient (-2 mbar below zero pressure).
Autoset.
6. High PEEP (High PEEP alarm control) Autoset
and user adjustable.
7. Low PIP (Low PIP alarm control). Autoset and
user adjustable.
8. Fail to cycle. Autoset.
9. Continuing positive pressure. (+5 mbar above
CPAP/PEEP for more than 4 seconds). Autoset.

120
Operational features

19.5.2 Alarm thresholds for Oscillatory modes


(invasive and non invasive - dual limb).
19.5.2.1 HFOV & nHFOV
The diagrams A & B show the pressure alarm
thresholds (invasive and non invasive modes).

Diagram B

1. Unexpected rise in delta P. (+5 mbar above


delta P). Autoset.
2. Unexpected drop in delta P. (-5 mbar below
delta P). Autoset.

Diagram A

A. Zero pressure line


B. Waveform
Alarm thresholds
1. Low pressure (Low Paw alarm control) Autoset
and user adjustable.
2. High pressure (High Paw alarm control)
Autoset and user adjustable.
3. High pressure threshold exceeded (+5 mbar
above PIP). Autoset.
4. High pressure threshold exceeded (+20 mbar
above PIP) Autoset.
5. Unexpected drop in mean P. (-5 mbar below
mean P). Autoset.
6. Unexpected rise in mean P. (+5 mbar above
mean P). Autoset.
7. Continuing positive pressure. (+15 mbar above
mean P for more than 4 seconds). Autoset.
8.Sub ambient (Mean pressure to go -2 mbar
below zero pressure). Autoset.

121
Operational features

19.5.2.2 HFOV+CMV (invasive - dual limb) 19.5.3 Alarm thresholds for conventional modes
The diagram below shows the pressure alarm (non invasive - single limb).
thresholds (invasive mode). The diagram below shows the pressure alarm
thresholds for conventional modes (non invasive).

A. Zero pressure line


B. Waveform
A. Zero pressure line Alarm thresholds
B. Waveform 1. Low Pressure (Low PEEP alarm control)
Alarm thresholds Autoset and user adjustable.
1. Low pressure (Low Paw alarm control) Autoset 2. High PIP (High PIP alarm control). Autoset and
and user adjustable. user adjustable.
2. High pressure (High Paw alarm control) 3. High pressure threshold exceeded (+5 mbar
Autoset and user adjustable. above PIP). Autoset.
3. High pressure threshold exceeded (+5 mbar 4. High pressure threshold exceeded (+20 mbar
above PIP). Autoset. above PIP) Autoset.
4. High pressure threshold exceeded (+20 mbar 5. Sub ambient (-2 mbar below zero pressure).
above PIP) Autoset. Autoset.
5. Pressure change detected. (See “Alarm 6. High PEEP (High PEEP alarm control) Autoset
message: Pressure change detected.” on and user adjustable.
page 204.) Autoset. 7. Low PIP (Low PIP alarm control). Autoset and
6. Continuing positive pressure. (+10 mbar above user adjustable.
mean P for more than 4 seconds). Autoset. 8. Fail to cycle. Autoset.
7. Sub ambient (Mean pressure to go -2 mbar 9. Continuing positive pressure. (+5 mbar above
below zero pressure). Autoset. CPAP/PEEP for mor than 4 seconds). Autoset.

122
Operational features

19.5.4 High pressure threshold alarm operation. 19.5.5 Low pressure threshold alarm operation
If a user set High PIP alarm threshold is crossed by Note: The user must be made aware that the
5 mbar or 20 mbar the ventilator carries out the Low Alarm threshold will only autotrack down
following actions. to 1mbar in conventional ventilation. If the
Crossing High PIP threshold by 5 mbar user wishes to set the alarm lower than 1mbar
then this has to be done manually. If the alarm
If the High PIP alarm threshold is exceeded by more threshold is manually set lower than 1mbar
than 5mbar the ventilator drops the fresh gas supply and a pressure related parameter is adjusted
for 3 seconds. It maintains the mean pressure and the low alarm threshold will return to 1mbar
stops ventilating. This is true for all modes of or to the threshold dictated by the CPAP
ventilation. The ventilator will re-instate the fresh pressure. The user will have to manually re-
gas supply after 3 seconds and then restart adjust the alarm threshold to the required
ventilation a further 5 seconds after re-instatement level.
of the fresh gas. The “High Pressure Threshold
Exceeded” alarm will sound until the condition is
Warning: If the user sets the low alarm
cleared. If the ventilator encounters the same
threshold below 1mbar the ventilator will not
conditions after restarting ventilation the cycle is
be able to detect a patient circuit
repeated.
disconnection of the following type:
Crossing the 20mbar ventilator set threshold Inspiratory limb disconnection from the ET
manifold complete with coloured restrictor.
If the High PIP alarm threshold is exceeded by more (In this case the low alarm will not be
than 20mbar the ventilator drops all the gas supplies triggered as it is set to 0 mbar or less, also the
for 6 seconds. It does not maintain the mean leak alarm will not activate as the restrictor is
pressure and stops ventilating. This is true for all still on the inspiratory limb.
modes of ventilation. The ventilator will re-instate
the fresh gas supply after 6 seconds and then The ventilator will also not instantly detect an
restart ventilation a further 2 seconds after re- ET tube disconnection from the flow sensor, if
instatement of the fresh gas. The “High Pressure the low alarm is set to 0 mbar or less. The
Threshold Exceeded” will sound until the condition ventilator will alarm with a “Breath Not
is cleared. If the ventilator encounters the same Detected” alarm after 20 seconds.
conditions after restarting ventilation the cycle is
repeated.

123
Operational features

19.6 Patient Circuits, Humidification 19.6.3 Nitric Oxide Therapy


and Nitric Oxide Therapy When the ventilator is used in conjunction with an
19.6.1 Invasive ventilation & autofeed Inhaled Nitric Oxide Delivery System, the ventilator
humidification chambers requires two NO scavenging filters (SLE part Nº
N4110 connected in parallel with a dual exhaust
When using the ventilator in invasive ventilation with
hose assembly SLE part Nº N4110/10) fitted to the
autofeed humidification chambers the water bag
exhalation block (remove the silencer). This is
should be mounted higher than the max Delta P or
supplied as a complete kit under SLE part Nº
MAX PIP being used. N4110/20. The flow of exhausted gas exceeds the
capability of a single scavenging filter.
Dual Exhaust Hose Assembly
SLE Part No: N4110/10

MAX
Delta P
or
MAX PIP

Note: Ensure that the autofeed humidification


chamber supply line is primed by forcing
water through the supply line into the
chamber. Exhalation block

Note: For non-invasive modes mount the bag NO Scavenging Filter


as high as possible. If the bag inflates due to SLE Part No: N4110
higher CPAP pressures then release the
pressure at regular intervals.
Caution: After using the ventilator with Nitric
To calculate the approximate height of the water Oxide therapy, rinse the exhalation block with
bag use the following conversion: water before cleaning, disinfection or
1 mbar = 1cm, then add 25cm to the calculated high autoclaving. This is to remove any deposits of
for the final height of the bag. NO that could react during steam autoclaving
Mounting the bag lower could allow the ventilator to with water to form Nitrous acid or Nitric acid.
pressurize the bag and thus prevent the chamber
from filling with water. Also, the bag in return Warning: Using the ventilator with only one
pressurizes the chamber which could cause high or N4110 scavenging filter, (fitted directly to the
sustained pressure alarms to be triggered. exhaust port) will cause a back pressure to be
generated. This will cause all the pressure
19.6.2 Non-Invasive ventilation & autofeed readings to become slightly elevated.
humidification chambers
When using the ventilator in non-invasive ventilation
with autofeed humidification chambers the water
bag should be mounted as high as possible. If the
bag inflates due to higher CPAP pressures then
release the pressure regularly from the bag.

124
Operational features

19.6.4 Nebulization of Medication

19.6.4.1 Nebulization using Aerogen® Note: Aerogen® USB Controller can only be
operated from a USB port on any medical
Caution: Only use Aerogen® USB Controller electrical equipment approved to IEC/EN
with the SLE6000. 60601-1 or Aerogen USB Controller AC/DC
adaptor.
Warning: Only use ultrasonic nebulization
devices with the SLE6000. 6 Open the plug on the nebulizer and use a pre-
A pneumatically driven nebulizer will cause filled ampoule or syringe to add medication to
increased pressure within the inspiratory limb the nebulizer. Close the plug.
of the circuit, which will trigger the “Blocked
Fresh Gas” alarm. Note: To avoid damage to the Aerogen® Solo,
do not use a syringe with a needle.
Warning: Do not use the flow sensor when
nebulizing medication. 7 To operate in 30 Minute Mode press the On/Off
button once.
When using the ventilator with a nebulizer,
the ventilator should be used as time cycled 8 To operate in 6 Hour Mode press the On/Off
pressure limited device by removal of the flow button from the off mode for >3 seconds.
sensor. 9 Verify the correct mode of operation is selected.
Removing the flow sensor from the ET 10 Verify that aerosol is visible.
manifold whilst still reconnected to the 11 When nebulization is complete remove the
ventilator is not advised as the “Breath Not
Aerogen® Solo and USB controller from the
Detected” alarm will become active and mask
circuit.
other alarm conditions that could arise.
12 Calibrate and replace the flow sensor if required.
Caution: Read and study all instructions
supplied with Aerogen® USB Controller.
19.7 Using the SLE6000 with SLE500E
1 Perform a functional test of the Aerogen®
and SLE500S medical air
nebulizer prior to use as described in the
compressors
Aerogen® IFU. Caution: When using the SLE6000 in
®
2 Connect the Aerogen Solo or Aerogen Pro ® conjunction with either the SLE500E or
nebulizer by firmly pushing into the T-piece. SLE500S medical air compressors the user
needs to be aware that the HFO performance
3 Connect the Aerogen® USB Controller to the is limited.
nebulizer.
The SLE500E or SLE500S medical air
4 Insert the nebulizer and the T-piece in the compressors maximum flow is 60 l/min the
breathing circuit. SLE6000 requires 85 l/min. This disparity will
only be evident in HFO mode where Delta P
5 The Aerogen® USB controller for use with
pressures of greater than 150 mbar will cause
Aerogen® Solo is powered from the Aerogen® the MAP (mean airway pressure) to be
Controller port situated on the rear of the unstable.
ventilator.

125
Operational features

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126
User interface - Standby mode

User interface description


“Standby mode” on page 128
“Ventilation mode” on page 140

127
User interface - Standby mode

20. User interface description 20.1.2 Information panel (2)


This section describes all the features of the user The information panel will display information and
interface. The chapter is divided into two sections, all associated ventilatory features.
the first Standby mode and the second Ventilation
20.1.3 Information bar (3)
mode. Standby mode describes the function of the
user interface whilst in Standby mode and The information bar is an area reserved at the top of
Ventilation mode the differences when in a the user interface that displays alarm messages,
ventilatory mode. time and date, power indicators. It also contains the
120 second alarm audio pause control and a multi
20.1 Standby mode function button.
Immediately after turning on the ventilator, the first
20.1.4 Generic button/panel functions
screen presented to the user will be “Standby”.
20.1.4.1 Panel functions
Warning. In “Standby” mode. The ventilator
Pressing the same control button that opened a
does not provide any patient support and all
panel, while the panel is open shall close the panel.
patient alarms are inactive. The information
panel carries the statement “Standby: Patient Pressing another control button shall close the
not ventilated”. current panel and open the associated panel of the
last pressed button. No changes to the original
menu shall take effect.
3 Pressing the ‘X’ button at the top right
 G
corner of the menu if required, shall close
the menu. No changes shall take effect.
20.1.4.2 Parameter time out
A If the ventilator is in a ventilation mode and the user
E doesn’t interact with a control for 15 seconds then
B
F the control shall be deselected and no changes
C shall take effect.
D
20.1.4.3 Panel time out
If the user doesn’t interact with a menu for 120s
then the window shall automatically close and no
changes shall take effect.

2
20.1.4.4 Button states
All the buttons have two states,
 Available and Selected. A selected
button is White. An available button is
1 dark grey.
1. User interface 20.1.4.5 Mode button (A)
2. Information panel This button selects the mode sub panels, Invasive,
3. Information bar Non Invasive and standby.
A. Mode button (Control Button) 20.1.4.6 Start/Resume Ventilation button (E)
B. Alarms button (Control Button) The mode button allows the user to select a mode of
ventilation.
C. Utilities button (Control Button)
D. Layout button (Control Button) 20.1.4.7 Alarms (B)
This button has no function in standby mode. When
E. Start/Resume ventilation button
pressed it will display the alarm sub panel with the
F. Calibration and utilities button factory or user set default values.
G. Multi function button
20.1.4.8 Utilities button (C)
20.1.1 User interface (1) This button selects the following sub panels:
The active display is referred to as the user Sensors (see “Sensors tab (without external sensor/
interface. Apart from the ON/OFF buttons all other s)” on page 131)
controls are through the user interface. All the Brightness (see “Brightness tab” on page 131)
controls are touch controls requiring a single touch System (see “System Tab” on page 132)
to operate.
Data (see “Data tab” on page 133)

128
User interface - Standby mode

20.1.4.9 Calibration & Utilities button (F) 20.1.6 Alarm button


This has the same function as the Utilities button
(C).
Touching “Alarm” button
20.1.4.10 Layout button (D) (D) activates the Alarm
This button selects the layout sub panel. In standby tabs.
mode only the trends can be selected. (see “Layout
Tab” on page 135) D
20.1.4.11 Multi function button (G)
This button has the following functions:
Lock/unlock screen.(See section 20.2.13 on page
144).
The Alarm panel has three available tabs: Limits
Alarm reset and alarm acknowledge.(See section
(E), History (F) and Loudness (G).
20.1.6 on page 129)
Note: The multi function button also changes
shape when activated for the Continue F G
E
without flow sensor alarm condition.

20.1.5 Mode button & Start/Resume Ventilation


button
Touching either button (A
or B) activates the mode
selection tabs.
A
B
The default tab is the Limits (E)
20.1.6.1 Limits tab
The Limits tab shows all available alarm thresholds.
The Mode panel has three available tabs: Invasive,
Non-invasive and Standby.
Note: The standby tab is available but
nonfunctional in standby mode.

Note: The mode that will be highlighted will


depend on whether the ventilator is set to
user set preferences, factory defaults or last
selected mode.

Select the required mode from area (1) and then


press the “Confirm” button (C) to select.

1 Note: The Limits tab is nonfunctional in


standby mode.

See section 20.2 on page 140 for mode related


descriptions.

129
User interface - Standby mode

20.1.6.2 History tab 20.1.6.3 Loudness tab


The History tab shows the last 1000 alarm events. The Loudness tab allows the user to adjust the
alarm sounder volume. The default setting is 60%.

The tab displays the following information for each


alarm event. The control is limited to 20% increments.
Priority - Indicated by colour. Red-High, Minimum setting 20% maximum 100%.
Yellow-Medium, Blue-Low.
Note: The user setting is reset to 60% on
Time - hh/mm power up.
Date - DD/MM/YYYY or MM/DD/YYYY
20.1.7 Utilities & Calibration & Utilities button
Duration in Hours, Minutes and Seconds
Touching “Utilities” button
Values - non functional in this release of (H) or the “Calibration &
software. Utilities” button (J)
Limit - the alarm setting activates the Utility tabs.
Not Ack - Indicator for user acknowledgment J
H
of alarm at time of activation
The alarm history can be viewed by using
the scroll arrows at the right hand side of the The Utility panel has four available tabs: Sensors
history. The single arrow is slow scroll the (K), Brightness (L), System (M) and Data (N).
double arrow is fast scroll. When at the
beginning or end of the list the user will only
be able to select arrows that can scroll
K L M N
through alarm messages.

130
User interface - Standby mode

20.1.7.1 Sensors tab (without external sensor/s) 20.1.7.3 Brightness tab


The sensor tab allows the user to calibrate the flow The Brightness tab allows the user to select Day or
sensor or perform a one point O2 calibration. Night mode and set the screen brightness for the
these modes.

Note: When the flow sensor is connected the


flow sensor calibration button is selected by The user change the set percentage brightness for
default. When using the ventilator without the each mode as stated below.
flow sensor only the one point O2 calibration Day mode: the default setting on at 70%
is selected by default. (Range 30% to 100%)
Night mode: the default setting on at 30%
Note: The latest calibration date & time will be (Range 20% to 60%).
displayed above the button.
Note: The day mode can only be decreased to
20.1.7.2 Sensors tab (with external sensor/s) 10% above the night mode setting. The night
The sensor tab allows the user to calibrate the flow mode can only be increased to 10% below the
sensor or perform a one point O2 calibration. day mode setting.

Note: Night mode is automatically cancelled


on the activation of an alarm.

131
User interface - Standby mode

20.1.7.4 System Tab 20.1.7.4.2 User preferences


The system tab allows the user to select from the
The user preferences button (P) allows the user to
following system related functions:
set the start up-defaults for the ventilator.
Set date and time (O)
User preferences (P)
Engineering mode (Q)
System information (R)
Screen Calibration (S)
System Update (T)

O
P
Q The access to the user preferences require the
R security code to be entered.
S See “User preferences” on page 266 for detailed
description.
T
20.1.7.4.3 Engineering Mode
The engineering mode button (Q) allows the service
engineer to access the setup and calibration
utilities.
20.1.7.4.1 Set date and time
The set time and date button (O) allows the user to
set the time and date for the ventilator.
Note: Daylight saving has to be manually set
by the user when required.

1. Set the Date and date format


2. Set the time.
 

1
Caution. Only trained service personnel
2 should access the engineering mode. For
information on Engineering mode please
consult the service manual. See chapter ’46.
Consumables & Accessories’ on page 280 for
service manual part number.

Note: Default date and time format defaults


can be set through user preferences.

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User interface - Standby mode

20.1.7.4.4 System information 20.1.7.4.6 System Update


The system information button (R) displays The System Update button (T) allows the service
ventilator system information. engineer to upgrade the ventilators software.
The subsystem version numbers are used to
determine the overall software version which is
displayed on this panel. See chapter ’36. Software
version identification’ on page 242 for further
information on the software version.
Note: Display Board CPU vitals, Elapsed time
from last service and input gas pressures are
primarily for use by service personnel.

20.1.7.4.5 Screen Calibration


The screen calibration button (S) allows the service
engineer to re-calibrate the touch screen.

Note: This button is only available in Version


1.0.43 software or higher.

Caution. Only trained service personnel


should access the Software Update feature.
For information on Software Update please
consult the service manual. See chapter ’46.
Consumables & Accessories’ on page 280 for
service manual part number.

20.1.7.5 Data tab


The data tab allows the user to select from the
Caution. Only trained service personnel
following export related functions:
should access the screen calibration. For
information on screen calibration please Patient log (U)
consult the service manual. See chapter ’46. Events log (V)
Consumables & Accessories’ on page 280 for
service manual part number. Screen captures (W)

Warning. Incorrect calibration of the touch


screen will render the ventilator inoperable.
U
V
W

133
User interface - Standby mode

20.1.7.5.1 Patient log 20.1.7.6 Downloading screen captures


Turn on the ventilator and allow it to enter Standby
The patient log button exports patient Trends,
mode.
Waveforms, Alarm Log & Events Log.
Insert a USB memory
Pressing the button (U) will display the "Start
stick into the data port
Export" button. If a USB memory stick is present the
at the rear of the
button will be active. See “SLE 6000 Event and
ventilator.
Patient Log viewer software” on page 270 for further
information.
20.1.7.5.2 Events log
The events log button exports the Events Log.
Pressing the button (V) will display the "Start Export"
button. If a USB memory stick is present the button Note: There are two USB ports on the rear of
will be active. See “SLE 6000 Event and Patient Log the ventilator. Use the port indicated (Data
viewer software” on page 270 for further Export).
information.

20.1.7.5.3 Screen capture
The screen capture button exports the last 10 USB
screen captures.
Pressing the button (W) will display the "Start
Export" button. If a USB memory stick is present the Activate the Utilities tabs (1) and select the Data tab
button will be active. (2).
See how to take screen captures in section ’20.2.15 2
Screen capture’ on page 144.


1

Select the Screen Captures button

Screen captures

134
User interface - Standby mode

On selection of the Screen Captures button the 20.1.8 Layout Tab


“Start Export” button becomes active. Press the The layout tab allows the user to select and
button to start the export to the USB memory stick. configure the Waveform (W), Loops (X), Trend (Y)
and SpO2 (Z) layouts prior to entering a ventilatory
mode.
Screen captures Start export

W X Y

The ventilator will display a progress bar during the Z


export process. Also displayed is a cancel button
that allows the user to terminate the export process.

The default selection in Standby mode is Trends.


Screen captures Start export
To view trends in Standby mode press the Layout
button and then the confirm button.
Cancel
To modify one of the layout formats
When complete the ventilator will indicate that the touch the required layout. The edit
data export was OK. button will appear.
Remove the USB memory stick from the ventilator.
The SLE6000 creates a folder with a identification
number that is unique to that ventilator. Press the edit button to enter the
Example: Ventilator ID 1001453795 selected layout panel.
Within the folder the user will find exported bitmap
files.
Each file is prefixed with the date followed by serial
code and then file type.
Note: Then ventilator will record the last
Example: layout selection and set it as the session
16_03_31_55929_ScreenCapture_00.bmp default.
Note: The ventilator does not overwrite any
existing files but creates new files with a
different serial code.
The ventilator will check the USB memory
stick for enough free space for the new export
files. If not enough free space is available the
ventilator will display the following message
“The USB stick does not have enough free
space. Minimum XMB free space needed”.

Note: If the user also exports the patient logs


or event logs these will be located within the
same folder.

The bitmaps can be viewed by most PC/MAC word


processor or file viewer applications.

135
User interface - Standby mode

20.1.8.1 Waveforms 20.1.8.2 Loops


The waveform panel allows the user to configure the The Loops panel allows the user to configure the
waveform panel in a ventilatory mode. waveform panel in a ventilatory mode.
Note: The configured waveform panel is not Note: The loops configured waveform panel is
visible in Standby mode. not visible in Standby mode.

Note: When the flow sensor is not connected Note: When the flow sensor is not connected.
the panel will show only the pressure the panel will show only the pressure
waveform as the default. waveform as the default.

The user can turn off two of the three available The Waveform panel is configured when loops are
waveforms. The available waveforms are: selected into 1 waveform (1), 1 primary loop (2) and
Pressure (Default On) 1 secondary loop (3).

Flow (Default On)


Volume (Default On) 1
The user can also change the style of the displayed
trends.
Filled - when turned on fills in the waveform with
colour.
Background - when turned on applies a time based
grid to the background of all the waveforms.
2
3

The waveform (1) can be configured to display.


Pressure (Default)
Flow
Volume
The primary loop (2) can be configured to display.
Flow against Volume - F/V
Flow against Pressure - F/P
Volume against pressure - V/P (Default)
The secondary loop (3) can be configured to
display.
Flow against Volume - F/V (Default)
Flow against Pressure - F/P
Volume against pressure - V/P

136
User interface - Standby mode

20.1.9 Capturing, Retrieving & Deleting Loops. 20.1.9.2 Trends


The trends are the only option that will be displayed
20.1.9.1 To capture Loops in Standby mode.
In the main waveform window two loops will be
displayed, the primary and secondary. The user has the choice of displaying up to eight
trends simultaneously in four displays lines. Each
Press the “Save” button. The current loops are display line can show a maximum of two trends.
saved. The ventilator will display the time and date The ventilator stores 14 days of trend data for each
as the loops are saved to memory at the top of each of the trends listed below.
loop.
The trend data is retained after powering down the
unit or after a total loss of power.
Save Keep Discard
The trends available in each display line are:
21/02/18 14:03 O2
Set O2
PIP
Two new buttons become active "Keep" and PEEP
"Discard". MAP
CPAP
Save Keep Discard ΔP
Vte
Vmin
21/02/18 14:03
RR
Triggers
Press “Discard” to erase the stored loops the user Resistance
will return to the initial “Save” button. Compliance
DCO2
Pres the “Keep” button to save the loops. On SpO2
pressing the “Keep” button two new buttons will
SIQ
appear.
Save Note: The user can display the same trend
New Hide Discard
twice in one display line.
The selection of trends is not affected by the
21/02/18 14:03
connection or disconnection of the flow
sensor.
The saved loops are displayed in white.
The default selection for Standby mode1:
Note: When viewing a stored loop the active Display line 1: PIP/PEEP
loops are shown as blue lines.
Display line 2: O2/Off
Pressing “Hide” will remove the saved loop from the Display line 3: MAP/Off
loop display areas. Two new buttons become active Display line 4: Off/Off
“Show” and “Delete”.
Note1. The defaults for display line 1 in a
Save ventilatory mode is different. The default is
New Show Delete
Pressure (Live)/Off. Pressure (Live) is not a
trend but the pressure waveform in real time.
21/02/18 14:03

Caution. Setting the defaults in Standby mode


Press “Show” to retrieve and display the saved will override the defaults of the ventilatory
loops. mode trends. If a trend is selected for Display
line 1 no real time waveforms will be
Press “Delete” to erase the saved loop from the
displayed on entering a ventilatory mode.
memory..

Note: The user cannot see the loop to be


deleted.

Pressing “Save New” the current loops are saved


and the “Keep” and “Discard” buttons will reappear.

137
User interface - Standby mode

20.1.9.2.1 Setting default trends. The Trend panel has one Style related control,
From the Trends Edit panel select the display line to Background.
be modified.
5

Background (5) - when turned on applies a time
based grid to the background of all the trends.
20.1.9.3 Single & double trend display
When a single trend is required for a display line the
trend window will display the trend as a blue line.
When two trends are displayed in the same display
line the second trend is orange and overlaid on top
the first.
20.1.9.4 Viewing trends
This will activate a drop down menu. After setting the required trend

   
views as previously described, A Zoom
press the confirm button to view
the trends in the waveform
windows. B Cursor
The associated trend view
controls will now become active.
These are located in the lower
C Scroll
right hand corner of the D 14:03:34
waveform windows.
Displayed are the Zoom (A),
E Current Zoom
1 hour

Cursor (B) and Scroll (C)


F
buttons. The trend start time (D).
The set zoom magnification (E).
The trend window locator bar
(F).
The drop down menu lists all the trend data that can
be displayed for that line. When selecting Zoom,
Cursor or Scroll the
The user can scroll cursor line and trend Zoom
down by using single value box becomes
arrow button (1).
 

4 active for each trend


The user can jump to Cursor
window.
the end of the list by 3 The values displayed in
pressing double arrow each box are coloured
button (2).
Scroll
1 and correspond to the
14:03:34
When the user has trend of the same colour
moved away from the 2 for that window. Current Zoom
1 hour
top of the list the up The values are for the
buttons (3 & 4) points that the cursor
become active. line intersects the trend
Touch the required line.
trend to select. If only one trend has ben selected for a particular
Repeat the process window only one value is shown.
for other display lines.
To cancel the
selection press the
Layout button.
To confirm the
selection press the
confirm button.

138
User interface - Standby mode

20.1.9.4.1 Zoom 20.1.9.4.3 Cursor


The Zoom function increases or The cursor function allows the user to
decreases the magnification of the Zoom move the cursor line through the Zoom
trend window time scale. current displayed trend window.
The zoom button when touched The cursor button when touched
activates the plus and minus buttons. Cursor activates the plus and minus buttons. Cursor
The plus and minus buttons are used Also displayed in the bottom part of
to increase/decrease the the panel are two icons that link the
Scroll plus/minus buttons to the direction of Scroll
magnification. Also displayed in the
bottom part of the panel are two icons 14:03:34 movement. 14:03:34
07-04
that link the plus/minus buttons to the Current Zoom Moving the cursor line to beyond the Current Zoom
level of magnification. 1 hour end of the window will move the line to 1 hour

The default time view for all the the beginning of the next time window.
windows is 1 hour. Decreasing the Time windows are dictated by the
zoom magnification is limited to Zoom magnification.
predefined steps of 2, 4, 6, 9, 12 & 24
hours. Increasing the zoom
magnification s limited to predefined steps of 30 and
15 minutes.
As the magnification is increased the Current Zoom
cursor in the trend window locator bar 24 hour

will increase or decrease dependant


on the zoom period.

20.1.9.4.2 Scroll
The scroll function allows the user to
move the cursor line through the 14 Zoom
days of trend data at the set
magnification.
The scroll button when touched Cursor
activates the plus and minus buttons.
Also displayed in the bottom part of
the panel are two icons that link the Scroll
plus/minus buttons to the direction of 14:03:34
movement.
Current Zoom
1 hour

As the user scrolls into the trend


history the trend window locator bar Scroll
moves accordingly.
14:03:34
The date will appear as the previous 07-04
days trend data is entered. Current Zoom
1 hour

139
User interface - Ventilation mode

20.2 Ventilation mode 20.2.2.2 Parameter states


All the parameters have three states, available
For the purpose of this section the user interface will preview, available active mode and selected.
be described in generic terms unless otherwise
specified. A selected button is White.
A An available preview button is black with a white
border.
An available button is dark grey.
20.2.2.3 Modifying a parameter
Touch the parameter required. O2
2 3

This will activate plus/minus


O2
buttons.

1. Parameters (Main and additional) Use the plus/minus


O2
2. Waveform panel buttons to adjust the
3. Monitored values parameter. After the
first adjustment the
The other areas are as per Standby mode. confirm button will
appear.
20.2.1 Alarm mute and pre-mute button (A)
The alarm mute/pre mute button Note: If no action is taken the selection is
allows the user to pre-mute all the cancelled after 15 seconds.
mutable alarms that may be
generated or mute an active patient Press the confirm O2 O2
alarm. button to accept the
The period that the audio component change.
of the alarm is paused for in both
scenarios is 120 seconds. The mute Audio Paused

time counts down to zero (The time


is displayed in minutes and seconds). 20.2.2.4 Turning “ON” a parameter function
Some parameters are inactive until VTV
20.2.2 Parameters turned on. Any inactive parameter has
the text OFF in the centre of the Off
20.2.2.1 Parameter types eyebrow.
Time based controls [Blue]
RR, Ti, Ti Max, Frequency, I:E ratio
Press an hold the parameter for 2 VTV
Pressure/Volume controls [Orange]: seconds.
CPAP, PIP, PIP Max, MAP (in HFOV), PEEP, Off
VTV, ΔP (in HFOV), Flow/Fresh Gas (Oxygen
Therapy)
Oxygen [Green] The plus/minus VTV O2
Additional Parameters [Blue]: buttons and the
confirm button will 3.0
Rise Time, Backup RR, Sigh RR, Sigh Ti
appear.
Additional parameters [White]:
Trigger Sensitivity, Termination Sensitivity The user can adjust the parameter and then confirm
Additional parameters [Orange] the setting or just confirm the activation of the
P support, Sigh P (in HFOV) parameter and then adjust the parameter as
previously described in section 20.2.2.3.
Note: If no action is taken the selection is
cancelled after 15 seconds.

140
User interface - Ventilation mode

20.2.3 Preview mode 20.2.4 Patient circuit selection


The User presses the Mode button and the mode The invasive mode panel contains Patient Circuit
panel appears. two buttons that allow the user to 10mm
select between 10mm and 15mm
diameter patient circuits.

For patients requiring tidal volumes


of less than 50ml use either: 10mm
15mm
For patients requiring tidal volumes
of greater than 50ml use: 15mm

Note: The selection of 15mm patient circuits


is only available for invasive ventilation.
By default, the Invasive tab will be selected on
Changing to non-invasive ventilation
startup, unless the user has pre-selected the non-
automatically selects 10mm patient circuits.
invasive tab as a default in the user preferences.
If already in a mode of ventilation, pressing the 20.2.5 Monitored values
mode button will bring up the mode panel with the
associated tab of the current mode. 20.2.5.1 Single column/double column
layout
On startup, the mode of ventilation that has been
The monitored values area to the right of
chosen in the user preferences will be pre-selected.
the waveform layout has two display
By default (factory default) this selection will be set
options. Single column with large
to ‘Invasive tab’. The selected mode button shall be
numbers and dual column with smaller
in ‘Selected’ state, all others shall be in ‘Available’
numbers.
state.
In single column mode the area displays
The user selects the ventilation mode of choice;
a maximum of 8 monitored values.
The controls of the selected mode shall appear
In double column mode the area displays
within the menu in ‘preview’ mode.
a maximum of 16 monitored values.
When already in a mode of ventilation, the settings
shall be the same as in the current mode, whenever 20.2.5.1.1 Switching between layouts
settings are common. The factory default is single column.The
In preview mode, the Confirm button will be default layout is set from user
available at all times. preferences, see “Interface tab” on
The user adjusts the ventilator parameters. page 268. Through user preferences the
user can set the user default to double
Presses parameter to be adjusted. column.
Parameter changes to ‘selected’ state. Which ever layout is selected the user in
User uses plus/minus keys to change the parameter a ventilatory mode can switch between
value. modes by touching the panel for 1
User presses a different parameter. second.
Previously pressed parameter returns to “available”
mode, but the parameter remains at the last
adjusted value. New parameter changes to
“selected” state.
User repeats process with other parameters if
required.
When the user is ready pressing the confirm button
accepts all the changes to the parameter controls
and activates the chosen mode.
The above procedure can be used when the user
wants to change more than one parameter at once,
while remaining in the same mode of ventilation.

141
User interface - Ventilation mode

20.2.6 Alarms tab - ventilatory mode 20.2.6.2 Alarm auto tracking/auto set thresholds
Selecting the alarm panel will now show all active The following alarms auto track the ventilation
alarm thresholds. parameters.
20.2.6.2.1 Invasive Conventional
Vte:
VTV Off:
High = 30 ml
Low = 0 ml
VTV On:
Below 10 ml
High = 130% of set value - minimum 3ml
above set
Low = 10% of set value
Above 10ml
The number of alarms thresholds will vary High = 30% above set
dependant on the mode selected or the number of
Low = 10% below set
selected sensors connected.
Vmin:
Note: Alarm threshold auto track the
associated parameter control. Adjust alarm VTV Off:
thresholds after ventilations parameter have High = 18 L
been set. Low = 0 L
VTV On:
Note: Selecting a ventilatory parameter will
automatically cancel the alarm panel and High = 200% of (Vte x RR)
discard any unconfirmed alarm threshold Low = 50% of (Vte x RR)
changes.
RR
20.2.6.1 Adjusting an alarm threshold Default = 100 BPM
Select the alarm panel. Touch Apn time
the threshold that requires
adjustment. Default = 15 seconds
The threshold will change colour Leak
to show that it has been Default = 25%
selected.
PIP
High = 5 mbar above set PIP
Low = 70% of the set PIP for the PIP
To adjust the threshold use the pressures between 8 mbar and 16 mbar,
plus minus buttons.
5 mbar below the set PIP for PIP pressures
between 17 and 50mbar
Press the confirm button when
threshold set. 90% of the set PIP for PIP pressures between
51 and 65 mbar
CPAP
Note: Each threshold change has to be
High = 5 mbar above set CPAP
confirmed independently.
Low = 5 mbar below set CPAP or 1 mbar if
Note: Selecting a new threshold without PEEP set to 6 mbar or lower
confirming the changes to the previous PEEP
threshold change will cause the previous High = 5 mbar above set PEEP
threshold setting to be discarded.
Low = 5 mbar below set PEEP or 1 mbar if
PEEP set to 6 mbar or lower

142
User interface - Ventilation mode

20.2.6.2.2 Invasive oscillatory 20.2.8 Utilities tab - ventilatory mode


HFOV High PIP (High Paw) Selecting the utilities panel will now show the sensor
tab.
High = 10 mbar above MAP + (ΔP ÷ 2)
HFOV+CMV High PIP (High Paw)
High = 10 mbar above PIP + (ΔP ÷ 2)
HFOV Low Paw (Low Pressure)
Low = 10 mbar below MAP - (ΔP ÷ 2)
HFOV+CMV Low Paw (Low Pressure)
Low = 10 mbar below PEEP - (ΔP ÷ 2)
20.2.6.2.3 Non invasive Conventional
RR
Default = 100 BPM
Apn time
Default = 15 seconds
The user can select between calibrating the flow
Leak sensor or the oxygen system (100%).
Default = 25%
Note: If using the ventilator without a flow
PIP sensor connected the Flow Sensor button will
High = 5 mbar above set PIP not be present.

Low = 70% of the set PIP for the PIP 20.2.8.1 Flow sensor calibration
pressures between 8 mbar and 16 mbar,
Caution. The flow sensor will have to be
5 mbar below the set PIP for PIP pressures
removed from the patient circuit.
between 17 and 50mbar
90% of the set PIP for PIP pressures between Occlude the flow sensor
51 and 65 mbar to prevent any flow


across the sensor wires.
CPAP
High = 5 mbar above set CPAP
Low = 5 mbar below set CPAP or 1 mbar if
PEEP set to 6 mbar or lower
PEEP
High = 5 mbar above set PEEP Caution: To avoid contamination of the flow
sensor use gloves when calibrating .
Low = 5 mbar below set PEEP or 1 mbar if
PEEP set to 6 mbar or lower Press the Start calibration button.
20.2.6.2.4 Non invasive oscillatory
HFOV High PIP (High Paw)
High = 10 mbar above MAP + (ΔP ÷ 2)
HFOV Low Paw (Low Pressure)
Low = 10 mbar below MAP - (ΔP ÷ 2)
The text “Calibrating..” will appear above the button.
The ventilator will sound a medium priority alarm
20.2.7 History and Loudness and display the alarm message “Calibrate Flow
These tabs operate as described in “History tab” on Sensor.”
page 130 and “Loudness tab” on page 130. When calibrated the button returns to its unpressed
state and the text “Calibration Completed.” will
appear.
Note: The Flow Sensor button has no default
setting. If the O2 calibration was the last used
this will be selected.

143
User interface - Ventilation mode

20.2.8.2 O2 calibration 20.2.13 Lock screen button


Select O2 button. The “Lock Screen” button is available when no
alarms are active. Pressing the button will lock the
screen.
The “Padlock” Icon will be
displayed on the button to
show that the screen is locked.

When locked all areas apart from the Lock screen


button are inactive.
In the event that an alarm is activated the screen is
automatically unlocked.
Note: In an alarm condition the lock screen
button becomes the alarm message “Reset”
button.
Press the “Start One Point O2 Calibration”.
The text “Calibrating..” will appear below the button Pressing the screen when locked will bring up the
and the O2% measured value will display the text information message “Screen is locked” and the
“CAL”. padlock icon will change colour to yellow.
The calibration will take approximately 4 minutes. To unlock the screen the user will have to press and
hold the button for 1 second.
The user can still set the O2% during the calibration.
Note: The O2 calibration button has no default 20.2.14 Pause/play
setting. If the Flow Sensor was the last used When in any ventilatory mode the pause
this will be selected. button will be available. The pause button
will pause the graphics section for 120
seconds.
Note: The O2 (%) trend will not display any
reading during the automatic oxygen To restart the graphics section the user
calibration routine. will have press the play button.

20.2.9 Brightness tab - ventilatory mode


20.2.15 Screen capture
See “Brightness tab” on page 131.
When in any ventilatory mode the pause
20.2.10 System tab - ventilatory mode or play button when touched and held for
3 seconds, will create a copy of the
The system tab has only two active buttons in a
screen and store it in the screen capture
ventilatory mode. Set Date and time and System
log.
information. All the other buttons are only available
when in Standby mode. See “Set date and time” on The screen capture log holds a maximum of 10
page 132 and “System information” on page 133 for screen captures.
more details. When the log is full the oldest screen capture is
discarded to create space for the new capture.
20.2.11 Data tab - ventilatory mode
Screen captures can only be downloaded in
The buttons are only available when in Standby “Standby mode”. See “Downloading screen
mode. See “Data tab” on page 133. captures” on page 134 for more information.
20.2.12 Layout
The layout tab allows the user to select and
configure the Waveform, Loops and Trend layouts.
The function is the same as in “Standby” mode, see
“Layout Tab” on page 135.

144
User interface - Ventilation mode

20.2.16 Alarm bar 20.2.18 Oscillation Pause


In the information area the alarm bar will be The Oscillation Pause button appears in the
displayed during an alarm condition. following invasive mode, HFOV and dual limb non
invasive mode nHFOV.
Pressing the Oscillation Pause button will deliver an
oscillatory pause at the set MAP for a maximum of
The alarm bar will display the highest priority alarm 60 seconds. Re-pressing the button during the 60
message. This is coloured red/amber/cyan when seconds will cancel the pause.
the alarm condition is active.
20.2.19 HFO Activity
The alarm bar is accompanied by the flashing light
bar and the high priority audile signal. The HFO activity button only appears in the invasive
HFOV+CMV mode. The HFO activity button allows
If the alarm condition clears with out a user the user to toggle between oscillations in the
interaction the bar will change colour to cyan. inspiration and expiration phases or just the
When the alarm bar is active the lock screen button expiratory phase.
changes function to become the alarm reset button. Touch the Additional
If the alarm condition has cleared pressing the reset Additional O2HFO Activity
Parameters button. This
arameters
button will clear the alarm bar. will activate the HFO
When no alarm conditions are active the information activity button.
area can display 1 of the following messages:
• Screen is locked Touch the HFO activity
Additional O2HFO Activity
• To unlock, press and hold for 1 second button.
Parameters
• Graphics Section paused Paused 120 secs

20.2.17 Mode specific controls


20.2.17.1 Manual breath (Inspiratory Hold) The activity indicator will replace the
O2
The manual breath button appears in the following button.
invasive modes, CPAP, CMV, PTV, PSV, SIMV and
dual/single limb non invasive modes, nCPAP,
NIPPV.
20.2.17.1.1 Manual breath This will activate plus/minus
O2
Pressing the manual breath button will deliver a buttons.Use the plus/minus
mechanical breath at the set PIP and Ti. buttons to toggle between
oscillations in the inspiration
20.2.17.1.2 Inspiratory Hold and expiration phases or just
Pressing the inspiratory hold button will deliver a the expiratory phase. Press the
mechanical breath at the set PIP for a maximum of confirm button to accept the
5 or 10 seconds. The time period is set through the change.
User Preferences. The set Ti is ignored. The indicator will change to the new
O2
20.2.17.2 Sigh (Sigh Hold) oscillation activity.
The Sigh button appears in the following invasive
mode, HFOV and dual limb non invasive mode
nHFOV.
20.2.17.2.1 Sigh
Pressing the Sigh button will deliver an oscillatory
pause at the set Sigh P and Sigh Ti.
20.2.17.2.2 Sigh Hold
Pressing the Sigh hold button will deliver an
oscillatory pause at the set Sigh P for a maximum of
5 or 10 seconds. The time period is set through the
User Preferences. The set Sigh Ti is ignored.

145
User interface - Ventilation mode

This page is intentionally left blank.

146
Technical data

Technical Data
“Technical description” on page 148
“Oxygen Calibration Routines” on page 151
“N5402-REV2 & N5302 flow sensor” on page 152
“Technical specification” on page 154
“Sensor Specifications” on page 190
“Alarms” on page 194
“Cleaning and disinfection” on page 235
“EMC compliance” on page 237
“Pneumatic unit diagram” on page 239
“Installation instructions” on page 260

147
Technical data

21. Technical description ventilator will continue to operate on its reserve


power supply.
The ventilator is a computer controlled ventilator.
The computer is divided into three main electronic The pneumatic system consists of the following:
subsystems that are housed in the upper An electronic oxygen blender blends the gas. The
(electronic) section of the ventilator. blended gas is then controlled via solenoid valves to
The three sub systems are user interface, monitor supply the conventional ventilation system and the
and controller. oscillatory system.
For conventional ventilation the gas is controlled by
The user interface subsystem controls the user two pressure regulators that produce positive and
interface, the display and the touchscreen. negative gas flows via the forward and reverse jets.
The controller subsystem regulates the pneumatic For oscillatory ventilation the gas flow is controlled
systems of the ventilator. by four in-line high speed solenoid valves that
produce the oscillatory gas flow via the forward and
The monitor subsystem collects and processes flow
reverse jets.
data and generates the alarms.
The exhalation block mounts onto two jet ports one
Each subsystem communicates with the other two forward/reverse and one mean pressure.
in a peer to peer protocol, i.e. no subsystem is in
complete control. Pressure is monitored via the proximal airway port
through a pair of pressure transducers with data
A communications module that integrates with the being sent to the monitor subsystem.
user interface and the monitor known as the ESMO Flow is monitored by a dual hot wire anemometer
provides connectivity for the Masimo SpO2 and mounted at the ET manifold with the flow data being
Covidians etCO2 external sensors. sent to the monitor subsystem.
Invasive modes shall utilize a two limb patient circuit
but non-invasive ventilation can be carried out either
on a two limb or on a single limb circuit. In two limb
circuit operation one limb is connected to the fresh
gas port and the other is connected to the
exhalation port.
The primary method of generating the patient
pressure in two limb use is from the driving jets in
the exhalation port.
A single limb non-invasive patient circuit is
connected to the fresh gas port so all patient
pressure control is achieved by directly controlling
the fresh gas flow.
The exhalation port on the ventilator is not
connected to the patient circuit. An increase in fresh
gas flow increases the patient pressure dependent
on the pneumatic resistance of the exhalation ‘limb’
The ventilator is fitted with an auto-ranging power of the single limb circuit (a single limb circuit still has
supply that is capable of working with mains an exhalation limb or port but it is not connected to
supplies of 100V to 240V 50-60 Hertz. the ventilator).
The ventilator can also run from an external 24V DC The patient pressure is monitored and the fresh gas
input. is controlled to maintain the desired patient
The ventilator carries an onboard backup power pressure.
source, which consists of two Lithium Ion battery The ventilator has two dedicated 5V inputs for
packs, that can power the ventilator in the event of a etCO2 and SpO2 monitoring.
mains power fail.
SpO2 can be monitored using Masimo SET SpO2
The batteries are charged from the ventilators sensors. These must be connected to the SLE
power supply. Internal battery power, 24V DC and uSpO2 cable.
mains power supply are monitored by the ventilators
other subsystems. etCO2 can be monitored using Microstream™
In normal modes of ventilation and with a fully technology using the Covidian MicroPod™
charged battery, in a mains power fail situation the

148
Technical data

22. Description of ventilatory Example: 5% termination sensitivity means that the


pressure support will terminate when the inspiratory
modes (Invasive) flow drops to 5% of the peak value. The level of
The ventilator has the ability to be used as either a pressure support can be manually adjusted by use
pressure controlled, volume targeted ventilator, as a of the PIP parameter control.
pressure limited, time cycled ventilator, and as a
high frequency oscillation ventilator. PSV can be used in the weaning process. Weaning
is achieved by reducing the support level as the
22.1 CPAP infant is able to make more effort.
Continuous positive airway pressure In this mode all the patient's breath attempts are
pressure supported, but mechanical breaths are
The ventilator generates a continuous positive
delivered at the set parameters (Ti, PEEP and PIP)
airway pressure at a level set by the User. The
when a patient effort is recognised.
apnoea alarm will sound if the patient has not made
any breath attempts within the set apnoea period. 22.4.1 PSV & VTV
The ventilator will provide backup breaths if This is as for basic PSV with Apnoea Support,
required. where the inspiratory pressure shall be controlled by
the ventilator to achieve the user set VTV (for
22.2 CMV assisted breaths).
Continuous Mandatory Ventilation
22.5 SIMV
In this mode the inspiratory cycle is initiated by the Synchronised Intermittent Mandatory
ventilator at a set BPM rate. The breaths are time Ventilation
cycled. The frequency of mandatory breaths is determined
by the BPM control. When a mandatory breath is
22.2.1 CMV & VTV
due an assist window opens and waits for a
This is as for basic CMV where the inspiratory patient's inspiratory effort. When this occurs the
pressure shall be controlled by the ventilator to ventilator delivers a synchronised breath (SIMV
achieve the user set VTV. breaths). Once the breath has been delivered the
assist window closes until the next set breath is due.
22.3 PTV
Time windows
Patient Triggered Ventilation

In this mode all the patient's breath attempts are


pressure supported. Mechanical breaths are
delivered at the set parameters (Ti, PEEP and PIP)
if no patient effort is recognised.
Assist windows
22.3.1 PTV & VTV
If the ventilator does not see a patient's attempt to
This is as for basic PTV where the inspiratory
breathe before the end of the defined time window
pressure shall be controlled by the ventilator to
then a mandatory breath is delivered. The
achieve the user set Vte (for assisted breaths).
mandatory breath point is the Time Window minus
22.4 PSV the Inspiratory Time.

Pressure Supported Ventilation Mandatory breath point

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 Inspiratory time
patient circuit. Changes in flow or volume signal
detects spontaneous breathing. 60
Time window =
BPM
The termination sensitivity is also user adjustable
from 0% - 50%.

149
Technical data

22.5.1 SIMV with P Support 23. Description of ventilatory


SIMV with P Support allows the user to select the
termination sensitivity and pressure support level on
modes (Non-invasive)
non SIMV breaths. Once a mechanical breath is The ventilator has the ability to be used as a
delivered to the patient, the flow to the infant rapidly pressure limited, time cycled ventilator, and as a
peaks and then decelerates to the termination high frequency oscillation ventilator. Using dual or
threshold, inspiration ends and expiration can begin. single limb delivery circuits.

SIMV with P Support produces time cycled, Note: O2 therapy is delivered by single limb
pressure limited breaths that are delivered at a set delivery circuit only.
BPM rate. Any additional patient breath attempts
are pressure supported (Flow cycled, pressure 23.1 nCPAP (Dual and Single limb)
limited).
Nasal Continuous positive airway pressure
22.5.2 SIMV & VTV
The ventilator generates a continuous positive
This is as for basic SIMV (with or without P airway pressure at a level set by the User. The
Support), where the inspiratory pressure shall be apnoea alarm will sound if the patient has not made
controlled by the ventilator to achieve the user set any breath attempts within the set apnoea period.
VTV (for assisted breaths).
The ventilator will provide backup breaths if
22.6 HFOV required.
High Frequency Oscillation
23.2 NIPPV (Dual limb)
In this mode, the ventilator shall deliver continuous Non-Invasive Intermittent Positive Pressure
high frequency oscillation. Small tidal volumes are ventilation
delivered at super physiological rates.
In this mode the inspiratory cycle is initiated by the
22.6.1 HFO & VTV ventilator at a set BPM rate. The breaths are time
This is as for basic H FO but automatically adjusts cycled.
the ΔP, in order to achieve the target Vte, set by the
user. 23.3 NIPPV Tr. (Dual limb)
Non-Invasive Intermittent Positive Pressure
22.7 HFOV+CMV ventilation Triggered
A combination of oscillations during the expiratory
In this mode all the patient's breath attempts are
or inspiratory & expiratory phase of a time cycled,
pressure supported. Mechanical breaths are
pressure limited breath in CMV mode.
delivered at the set parameters (Ti, PEEP and PIP)
if no patient effort is recognized.

23.4 nHFOV (Dual limb only)


Nasal High Frequency Oscillation

In this mode, the ventilator shall deliver continuous


high frequency oscillation.

23.5 O2 Therapy (Single limb only)


In this mode, the ventilator shall deliver continuous
flow at the set oxygen concentration.

150
Technical data

24. Oxygen Calibration Routines If the ventilator is carrying out the standard single
point 100% calibration the user will be unable to run
The ventilator has two oxygen cell calibration
a two point calibration until it is complete.
routines. The first calibration is the 100% oxygen
calibration (one point). This calibration is carried out In a ventilation mode the O2 measured value will
at the following intervals after the unit is turned on: read “CAL” in the O2 parameter control until the
start up, 10 minutes, 30 minutes, 60 minutes, 90
routine is complete.
minutes and then at 8 hourly intervals.
The second routine is the 21% and 100% oxygen
calibration (two point). This calibration should only
be carried out if the oxygen cell has been replaced
or has registered below 21% (cell drifting with age).

Warning: The user cannot carry out the two


point calibration whilst connected to a
patient. The ventilator has to be placed in
“Standby” mode and the calibration process
will deliver 21% O2 to the patient for 3
minutes.

24.1 One Point O2 Calibration


The user can carry out a one point calibration of the
system by accessing the oxygen sensor calibration
panel from the services panel.
The ventilator can be connected to a patient for this
calibration.
The ventilator will continue to deliver the user set
percentage of O2 during calibration.

The O2 measured value will read “CAL”.

Note: The ability to carry out a one point O2


calibration is only available when the
ventilator is set to a ventilatory mode.

24.2 Two Point O2 Calibration


The two point calibration routine can only be
performed from the Engineering mode.

Caution. Only trained service personnel


should access the engineering mode. For
information on Engineering mode please
consult the service manual. See chapter ’46.
Consumables & Accessories’ on page 280 for
service manual part number.

Carrying out a Two Point O2 Calibration button the


user will have to wait 6 minutes before carrying out
any new operation.
The ventilator will start with a 21% calibration for 3
minutes followed by a 100% calibration for 3
minutes.

Warning: The user cannot select a ventilation


mode whilst the two point calibration process
is running.

151
Technical data

25. N5402-REV2 & N5302 flow Occlude the flow sensor to


prevent any flow across the
sensor


sensor wires.
The ventilator employs a low dead space (<1ml),
heated wire anemometer sensor. To minimise dead
space the sensor body fills much of the ET tube
adaptor and patient circuit connection.
Press the Start calibration button and the following
Warning: Do not use any nebulized gases text “Calibrating..” will be displayed above the
(medications, salt solutions, etc.) in button.
conjunction with the sensor as they are likely
to degrade the performance of the sensor and When the calibrations has passed the test
subsequent displayed accuracies. “Calibration completed” will appear.

The flow sensor is now calibrated.


Caution: The flow sensor is a serviceable item
and may require cleaning during use. Note: The flow sensor should be calibrated
every 24 hours whilst in use, if the patient’s
SLE offer two types of sensor the N5402-REV2 condition permits.
which is a reusable sensor or the N5302 which is a
single use flow sensor. Note: The Calibration procedure is the same
for the N5402-REV2 and N5302 sensors.

N5302 N5402-REV2
Warning: Do not use the N5302 flow sensor if
its packaging has been damaged.

Warning: Do not use this flow sensor to


monitor patients with ET tube sizes larger
than 5.0 mm or that require more than 30 l/
min.

Note: The N5302 flow sensor is a single use


device. It is supplied sterile. The sensor can
be cleaned during use, but cannot be re-
sterilized. It should be discarded after use as
clinical waste. The N5302 flow sensor can be
cleaned by rinsing into sterile water.

Before re-insertion into the patient circuit the user


must calibrate the flow sensor.

25.1 Calibration of the Flow Sensor


Connect the flow sensor cable to the flow sensor.
Ensure that the cable connector key fits into the rear
notch of the flow sensor connector.

The ventilator will alarm calibrate flow sensor. Press


the “Calibrate” button in the information bar to
activate the sensor panel or press the “Utilities”
button or the “Calibration and Utilities” Button.

152
Technical data

25.2 Cleaning and high level disinfection 25.2.3 High level disinfection
of the N5402-REV2 Sensor Autoclave at

Warning: Before each use the sensor must be 134ºC (277ºF) (Allowable variation of temperature
checked for damage. Damaged parts must of +3ºC) at 220kPa (32psi) with a minimum holding
not be used. time of 3 minutes.

Remove the flow sensor connecting cable before or


any cleaning, high level disinfection. 121ºC (248ºF) (Allowable variation of temperature
Rinse the sensor body immediately after use and of +3ºC) at 96kPa (14.1psi) with a minimum holding
put it into a disinfectant (recommended by the time of 15 minutes.
infection control authority of the hospital /
organization), otherwise the sensor will encrust and Note: The sensor must not be connected to
cannot be used any more. other standard connectors when autoclaved
to prevent cracking. Ensure no other
Flow sensor
components/items are lying on the sensor
connecting cble
during the autoclaving process.
(Do not autoclave or
immerse in liquids)
ET Manifold port

Flow sensor body


ET tube port

Warning: Do not clean the flow sensor with


compressed air or water jet. As this will
destroy the sensor wires.

Prior to first use as well as after each use clean or


disinfect/high level disinfection the sensor.

25.2.1 Cleaning:
A soap solution or mild alkaline solution should be
used.

25.2.2 Disinfection:
Use commercially available disinfectants that are
recommended for use with PLASTIC MATERIALS.
Immersion times and concentrations stated must be
in accordance with manufacturer’s instructions

Note: Disinfectants containing compounds


similar to PHENOL or ALKYLAMINES
(Glucorrotamine) are unsuitable.

Note: Eliminate all residues of cleaning


agents and disinfectant used by thoroughly
rinsing with sterile water after each cleaning
and disinfecting procedure.

153
Technical data

26. Technical specification 26.1.2 CMV mode


Respiratory Rate (RR): 1 to 150
26.1 Operating Modes - Conventional Resolution . . . . . . . . 1 BPM
Invasive Ventilation Factory set default:. . 30 mbar
This section summarises the specification of the
SLE6000 ventilator in terms of the modes, ranges Inspiratory Time (Ti): 0.1 to 3.0 seconds
alarm limits on the operator adjustable controls and Resolution: . . . . . . . . 0.01 second
their accuracy. It also summarizes the mechanical Factory set default:. . 0.40 second.
and electrical power constraints.
PEEP Pressure - HFO pneumatics:
Note: If the ventilator is set to cmH2O via user 0 to 35 mbar
preferences substitute cmH2O for mbar. PEEP Pressure - Conventional pneumatics
1 to 35 mbar
26.1.1 CPAP mode Resolution . . . . . . . . 0.5 <10 mbar,
Inspiratory Time (Ti): . 0.1 to 3.0 seconds 1 mbar >10 mbar)
Resolution: . . . . . . . . 0.01 second) Factory set default:. . 4.0 mbar
Factory set default: . . 0.40 second.
PIP Pressure: . . . . . . 0 to 65 mbar
CPAP Pressure - HFO pneumatics: Resolution: . . . . . . . . 1 mbar
0 to 35 mbar Default: . . . . . . . . . . . 15 mbar
CPAP Pressure - Conventional pneumatics:
1 to 35 mbar VTV: . . . . . . . . . . . . . 2 to 300 ml
Resolution: . . . . . . . . 0.5 mbar <10mbar, 3 to 300 ml with etCO2 on.
1 mbar >10mbar) Factory set default: . Set to “Off”
Factory set default: . . 4.0 mbar Factory set default: . 3 ml when "On"

PIP Pressure: . . . . . . 0 to 65 mbar VTV control, when enabled becomes Vte Target
Resolution: . . . . . . . . 1 mbar control.
Factory set default: . . 15 mbar From 2 ml to 9.8 ml the parameter increments in 0.2
ml steps (Fine resolution)
O2 concentration: . . . 21 to 100% From 10 ml to 100 ml the parameter increments in
Resolution: . . . . . . . . 1% 1ml steps (Standard resolution).
Factory set default: . . 21% From 100 ml to 300 ml the parameter increments in
5ml steps (Coarse resolution).
Additional Parameters:
Apnoea Backup Rate (RR Backup control): O2 concentration: . . 21 to 100%
1 to 150 BPM Resolution: . . . . . . . . 1%
Resolution: . . . . . . . . 1 BPM Factory set default:. . 21%
Factory set default: . . 40 mbar
Additional Parameters:
Rise Time: . . . . . . . . 0.0 to 3.0 seconds Rise Time: . . . . . . . . 0.0 to 3.0 seconds
Resolution . . . . . . . . . 0.01 second Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.04 seconds Factory set default:. . 0.04 seconds

Trigger sensitivity with flow sensor


Trig Sens: . . . . . . . . . 0.2 l/min to 20 l/min
Resolution: . . . . . . . . 0.2 l/min
Factory set default: . . 0.6 l/min
Trigger sensitivity without flow sensor
Trig Sens: . . . . . . . . . 1% to 100%
Resolution: . . . . . . . . 1%
Factory set default: . . 50%

154
Technical data

26.1.3 PTV mode 26.1.4 PSV mode


Respiratory Rate (RR): 1 to 150 Respiratory Rate (RR): 1 to 150 BPM
Resolution: . . . . . . . . 1 BPM Resolution: . . . . . . . . 1 BPM
Factory set default: . . 30 BPM Factory set default:. . 30 BPM

Inspiratory Time (Ti ): 0.1 to 3.0 seconds Insp.Time (Ti Max):. . 0.1 to 3.0 seconds
Resolution . . . . . . . . . 0.01 second Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.40 second Factory set default:. . 0.40 second

PEEP Pressure - HFO pneumatics: PEEP Pressure - HFO pneumatics:


0 to 35 mbar 0 to 35 mbar
PEEP Pressure - Conventional pneumatics PEEP Pressure - Conventional pneumatics
1 to 35 mbar 1 to 35 mbar
Resolution: . . . . . . . . 0.5 mbar <10 mbar, Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar 1 mbar >10mbar)
Factory set default: . . 4.0 mbar Factory set default:. . 4.0 mbar

PIP Pressure: . . . . . . 0 to 65 mbar PIP Pressure: . . . . . . 0 to 65 mbar


Resolution: . . . . . . . . 1 mbar Resolution: . . . . . . . . 1 mbar
Factory set default: . . 15 mbar Factory set default:. . 15 mbar

VTV: . . . . . . . . . . . . . 2 to 300 ml VTV: . . . . . . . . . . . . . 2 to 300 ml


3 to 300 ml with etCO2 on. 3 to 300 ml with etCO2 on.
Factory set default: . . Set to “Off” Factory set default:. . Set to “Off”
Factory set default: . . 3 ml when "On" Factory set default:. . 3 ml when "On"

VTV control, when enabled becomes Vte Target VTV control, when enabled becomes Vte Target
control. control.
From 2 ml to 9.8 ml the parameter increments in 0.2 From 2 ml to 9.8 ml the parameter increments in 0.2
ml steps (Fine resolution) ml steps (Fine resolution)
From 10 ml to 100 ml the parameter increments in From 10 ml to 100 ml the parameter increments in
1ml steps (Standard resolution). 1ml steps (Standard resolution).
From 100 ml to 300 ml the parameter increments in From 100 ml to 300 ml the parameter increments in
5ml steps (Coarse resolution). 5ml steps (Coarse resolution).
O2 concentration: . . 21 to 100%
O2 concentration: . . . 21 to 100% Resolution: . . . . . . . . 1%
Resolution: . . . . . . . . 1% Factory set default:. . 21%
Factory set default: . . 21%
Additional Parameters:
Additional Parameters:
Rise Time: . . . . . . . . 0.0 to 3.0 seconds
Rise Time: . . . . . . . . . 0.0 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second
Resolution: . . . . . . . . 0.01 second
Factory set default:. . 0.04 seconds
Factory set default: . . 0.04 seconds
Trigger sensitivity with flow sensor
Trigger sensitivity with flow sensor
Trig Sens: . . . . . . . . . 0.2 l/min to 20 l/min
Trig Sens: . . . . . . . . . 0.2 l/min to 20 l/min
Resolution: . . . . . . . . 0.2 l/min
Resolution: . . . . . . . . 0.2 l/min
Factory set default:. . 0.6 l/min
Factory set default: . . 0.6 l/min
Trigger sensitivity without flow sensor
Trigger sensitivity without flow sensor
Trig Sens: . . . . . . . . . 1% to 100%
Trig Sens: . . . . . . . . . 1% to 100%
Resolution: . . . . . . . . 1%
Resolution: . . . . . . . . 1%
Factory set default:. . 50%
Factory set default: . . 50%

155
Technical data

Termination Sensitivity (Term Sens control): Trigger sensitivity with flow sensor
5 to 50% Trig Sens: . . . . . . . . . 0.2 l/min to 20 l/min
Resolution . . . . . . . . . 5% Resolution: . . . . . . . . 0.2 l/min
Factory set default: . . 5% Factory set default:. . 0.6 l/min
Trigger sensitivity without flow sensor
26.1.5 SIMV mode
Trig Sens: . . . . . . . . . 1% to 100%
Respiratory Rate (RR): 1 to 150 BPM
Resolution: . . . . . . . . 1%
Resolution: . . . . . . . . 1 BPM
Factory set default:. . 50%
Factory set default: . . 30 BPM
Termination Sensitivity (Term Sens control):
Inspiratory Time (Ti): . 0.1 to 3.0 seconds
5 to 50%
Resolution . . . . . . . . . 0.01 second
Resolution . . . . . . . . 5%
Factory set default: . . 0.40 second
Factory set default:. . 5%
PEEP Pressure - HFO pneumatics: Note: Termination Sensitivity parameter is not
0 to 35 mbar shown when pressure support (P Support) is
PEEP Pressure - Conventional pneumatics off.
1 to 35 mbar
Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar
Factory set default: . . 4.0 mbar

PIP Pressure: . . . . . . 0 to 65 mbar


Resolution: . . . . . . . . 1 mbar
Factory set default: . . 15 mbar

VTV: . . . . . . . . . . . . . 2 to 300 ml
3 to 300 ml with etCO2 on
Factory set default: . . Set to “Off”
Factory set default: . . 3 ml when "On"

VTV control, when enabled becomes Vte Target


control.
From 2 ml to 9.8 ml the parameter increments in 0.2
ml steps (Fine resolution)
From 10 ml to 100 ml the parameter increments in
1ml steps (Standard resolution).
From 100 ml to 300 ml the parameter increments in
5ml steps (Coarse resolution).
O2 concentration: . . . 21 to 100%
Resolution: . . . . . . . . 1%
Factory set default: . . 21%

Additional Parameters:
Rise Time: . . . . . . . . . 0.0 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.04 second

P Support: . . . . . . . . . 0 to 65 mbar
Factory set default: . . Set to “Off”
Factory set default: . . 8 mbar when "On"

156
Technical data

26.1.6 HFOV mode 26.1.7 HFOV+CMV mode


Frequency: . . . . . . . . 3 to 20 Hz Respiratory Rate (RR): 1 to 150 BPM
Resolution: . . . . . . . . 0.1 Hz Resolution: . . . . . . . . 1 BPM
Factory set default: . . 10.0 Hz Factory set default:. . 30 BPM

I: E Ratio: . . . . . . . . . 1:1 / 1:2 / 1:3 Inspiratory Time (Ti):. 0.1 to 3.0 seconds
Factory set default: . . 1:1 Resolution: . . . . . . . . 0.01 second
Factory set default:. . 0.40 second
MAP: . . . . . . . . . . . . . 0 to 45 mbar
Resolution: . . . . . . . . 1 mbar Frequency Range: . . 3 to 20Hz
Factory set default: . . 5 mbar Resolution: . . . . . . . . 0.1Hz
Factory set default:. . 10.0 Hz.
Delta P Range: . . . . . 4 to 180 mbar
Resolution: . . . . . . . . 1 mbar PEEP Pressure: . . . . 0 to 35 mbar
Factory set default: . . 4 mbar Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar
O2 concentration: . . . 21 to 100% Factory set default:. . 4.0 mbar
Resolution: . . . . . . . . 1%
Factory set default: . . 21% PIP Pressure: . . . . . . 0 to 65 mbar
Resolution: . . . . . . . . 1 mbar
Additional Parameters: Factory set default:. . 15 mbar
Sigh RR: . . . . . . . . . . 1 to 150 BPM Delta P Range: . . . . 4 to 180 mbar
Resolution: . . . . . . . . 1 BPM Resolution: . . . . . . . . 1 mbar
Factory set default: . . Set to “Off” Factory set default:. . 4 mbar
Factory set default: . . 30 BPM when "On"
O2 concentration: . . 21 to 100%
Sigh Ti control: . . . . . 0.1 to 3.0 seconds
Resolution: . . . . . . . . 1%
Resolution: . . . . . . . . 0.01 second
Factory set default:. . 21%
Factory set default: . . 0.40 second
Additional Parameters:
Sigh P control: . . . . . . 0 to 45 mbar
HFO Activity:. . . . . . . Oscillation on both high and
Resolution: . . . . . . . . 1 mbar low cycles.
Factory set default: . . 20 mbar Oscillation on low cycle only.
Oscillation Pause:. . . 60 seconds
VTV: . . . . . . . . . . . . . 2 to 50 ml
3 to 50 ml with etCO2 on
Factory set default: . . Set to “Off”
Factory set default: . . 2 ml when "On"

VTV control, when enabled becomes Vte Target


control.
From 2 ml to 9.8 ml the parameter increments in 0.2
ml steps (Fine resolution)
From 10 ml to 50 ml the parameter increments in
1ml steps (Standard resolution).

157
Technical data

26.2 Operating Modes Conventional Non 26.2.2 NIPPV D mode (Dual Limb)
Invasive Ventilation Respiratory Rate (RR): 1 to 150 BPM
Resolution: . . . . . . . . 1 BPM
26.2.1 nCPAP D mode (Dual Limb)
Factory set default:. . 30 BPM
Inspiratory Time (Ti): . 0.1 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second
Inspiratory Time (Ti):. 0.1 to 3.0 seconds
Factory set default: . . 0.40 second
Resolution: . . . . . . . . 0.01 second
CPAP Pressure - HFO pneumatics: Factory set default:. . 0.40 second
0 to 35 mbar
CPAP Pressure - Conventional pneumatics: PEEP Pressure - HFO pneumatics:
1 to 35 mbar 0 to 35 mbar
Resolution: . . . . . . . . 0.5 mbar <10 mbar, PEEP Pressure - Conventional pneumatics
1 mbar >10 mbar 1 to 35 mbar
Factory set default: . . 4 mbar Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar
PIP Pressure: . . . . . . 0 to 65 mbar Factory set default:. . 4 mbar
Resolution: . . . . . . . . 1mbar
PIP Pressure: . . . . . . 0 to 65 mbar
Factory set default: . . 15mbar
Resolution: . . . . . . . . 1 mbar)
O2 concentration: . . . 21 to 100% Factory set default:. . 15 mbar
Resolution: . . . . . . . . 1%
O2 concentration: . . 21 to 100%
Factory set default: . . 21%
Resolution: . . . . . . . . 1%
Additional Parameters: Factory set default:. . 21%
RR Backup control: . . 1 to 150 BPM
Additional Parameters:
Resolution: . . . . . . . . 1 BPM
Rise Time: . . . . . . . . 0.0 to 3.0 seconds
Factory set default: . . Set to “Off”
Resolution: . . . . . . . . 0.01 second
Factory set default: . . 40 BPM when "On"
Factory set default:. . 0.04 second
Rise Time: . . . . . . . . . 0.0 to 3.0 seconds
26.2.3 NIPPV Tr. mode (Dual Limb)
Resolution: . . . . . . . . 0.01 second
Respiratory Rate (RR): 1 to 150 BPM
Factory set default: . . 0.04 second
Resolution: . . . . . . . . 1 BPM
Trig Sens: . . . . . . . . . 1% to 100% Factory set default:. . 30 BPM
Resolution: . . . . . . . . 1%
Inspiratory Time (Ti):. 0.1 to 3.0 seconds
Factory set default: . . 50%
Resolution: . . . . . . . . 0.01 second
Factory set default:. . 0.40 second

PEEP Pressure - HFO pneumatics:


0 to 35 mbar
PEEP Pressure - Conventional pneumatics
1 to 35 mbar
Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar
Factory set default:. . 4 mbar

PIP Pressure: . . . . . . 0 to 65 mbar


Resolution: . . . . . . . . 1 mbar
Factory set default:. . 15 mbar

O2 concentration: . . 21 to 100%
Resolution: . . . . . . . . 1%
Factory set default:. . 21%

158
Technical data

Additional Parameters: 26.2.5 nCPAP S mode (Single Limb)


Rise Time: . . . . . . . . . 0.0 to 3.0 seconds Inspiratory Time (Ti):. 0.1 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.04 second Factory set default:. . 0.50 second

Trig Sens: . . . . . . . . . 1% to 100% CPAP Pressure: . . . . 2 to 15 mbar


Resolution: . . . . . . . . 1% Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar
Factory set default: . . 50%
Factory set default:. . 4.0 mbar

26.2.4 nHFOV mode (Dual Limb) PIP Pressure: . . . . . . 2 to 25 mbar


Frequency: . . . . . . . . 3 to 20Hz Resolution: . . . . . . . . 1mbar
Resolution: . . . . . . . . 0.1Hz Factory set default:. . 10mbar
Factory set default: . . 10.0 Hz
O2 concentration: . . 21 to 100%
I: E Ratio: . . . . . . . . . 1:1 / 1:2 / 1:3 Resolution: . . . . . . . . 1%
Factory set default: . . 1:1 Factory set default:. . 21%

Mean airway pressure (MAP control): Additional Parameters:


0 to 45 mbar RR Backup control: . 1 to 10 BPM
Resolution: . . . . . . . . 1 mbar Resolution: . . . . . . . . 1 BPM
Factory set default: . . 5 mbar Factory set default: . Set to “Off”
Factory set default: . 10 BPM when "On"
Delta P Range: . . . . . 4 to 180 mbar
Resolution: . . . . . . . . 1 mbar Trig Sens: . . . . . . . . . 1% to 100%
Factory set default: . . 4 mbar Resolution: . . . . . . . . 1%
Factory set default:. . 50%
O2 concentration: . . . 21 to 100%
Resolution: . . . . . . . . 1%
26.2.6 DuoPAP mode (Single Limb)
Factory set default: . . 21%
Respiratory Rate (RR): 1 to 60 BPM
Additional Parameters: Resolution: . . . . . . . . 1 BPM
Sigh RR: . . . . . . . . . . 1 to 150 BPM Factory set default:. . 20 BPM
Resolution: . . . . . . . . 1 BPM
Inspiratory Time (Ti):. 0.1 to 3.0 seconds
Factory set default: . . Set to “Off”
Resolution: . . . . . . . . 0.01 second
Factory set default: . . 30 BPM when "On"
Factory set default:. . 0.50 second
Sigh Ti control: . . . . . 0.1 to 3.0 seconds
PEEP Pressure: . . . . 2 to 15 mbar
Resolution: . . . . . . . . 0.01 second)
Resolution: . . . . . . . . 0.5 mbar <10 mbar,
Factory set default: . . 0.40 second 1 mbar >10 mbar
Factory set default:. . 4.0 mbar
Sigh P control: . . . . . . 0 to 45 mbar
Resolution: . . . . . . . . 1 mbar PIP Pressure: . . . . . . 2 to 25 mbar
Factory set default: . . 10 mbar Resolution: . . . . . . . . 1mbar
Factory set default:. . 10mbar

O2 concentration: . . 21 to 100%
Resolution: . . . . . . . . 1%
Factory set default:. . 21%

159
Technical data

26.2.7 O2 therapy (Single Limb) 26.3 Mode of operation


Flow Rate: . . . . . . . . . 2 to 30 l/min The ventilator is designed for continuous operation.
Resolution: . . . . . . . . 0.1 l/min
Factory set default: . . 8.0 l/min. 26.4 Controls

O2 concentration: . . . 21 to 100% 26.4.1 Power Button


The ON/OFF button has an integrated LED to
Resolution: . . . . . . . . 1%
indicate status of the ventilator, where:
Factory set default: . . 21%
“LED Off” means the unit is off and no mains power
is connected to the system,
26.2.8 OxyGenie
“Green” colour means unit is on and ready to use,
O2 range:. . . . . . . . . . 21 to 100%
Target ranges: . . . . . . 90-94, 91-95, 92-96, 94-98 “Amber” colour means the ventilator is off, mains
power is connected and the internal batteries are
26.2.8.1 OxyGenie PCLCS attributes fully charged,
For normal use case
Response time . . . . . 19 seconds “Flashing Amber” colour means the ventilator is off,
the mains power is connected and the internal
Settling time . . . . . . . 29 seconds
batteries are charging;
Overshoot . . . . . . . . . 4%
For worst use case 26.4.2 User Interface
Response time . . . . . 20 seconds The SLE6000 is fitted with a colour display with a
Settling time . . . . . . . 38 seconds screen resolution of 1024 by 768 pixels.
Overshoot . . . . . . . . . 4% The screen size is 12.1” with an LED backlight.

The touch screen is a 5 wire resistive type suitable


for operation whilst wearing medical gloves.

26.4.2.1 Buttons
The following buttons are accessible via the touch
screen.

Button Description
Opens the mode tabs
Mode Single press to select or cancel

Open the alarm tabs


Alarms Single press to select or cancel

Opens the utilities tabs


Utilities Single press to select or cancel

Opens the layout tabs


Layout Single press to select or cancel

Opens the mode tabs


Start / Resume ventilation
Single press to select

Opens the utilities tabs


Calibration & Utilities
Single press to select

Locks the screen


Lock Screen
Single press to select

Unlock the screen


Touch and hold for 1 second

Reset the active alarm or


Reset clears an alarm message
Single press to select

160
Technical data

Button Description Button Description


Selects sensors tab Selects the Oxygen
Calibrate O2 calibration
Single press to select
Single press to select
Selects CPAP mode
CPAP
Single press to select or cancel
Starts the calibration routine
Start One Point O2 Calibration
Single press to select
Selects CMV mode Selects the day screen mode
CMV Day
Single press to select or cancel
Single press to select

Selects PTV mode Selects the night screen


PTV
Single press to select or cancel Night mode
Single press to select
Selects PSV mode
PSV Selects the brightness %
Single press to select or cancel 70%
Single press to select
Selects SIMV mode
SIMV
Single press to select or cancel
Selects the date/time buttons
Set Date and Time
Single press to select
Selects HFOV mode Selects the code panel for
HFOV
Single press to select or cancel User Preferences user preference setup mode
Selects HFOV+CMV mode Single press to select
HFOV+CMV Single press to select or Selects the code panel for
cancel Engineering Mode engineering mode
Single press to select
Selects NCPAP mode
NCPAP Dual or Single limb Displays the system
Single press to select or cancel System information information
Selects NIPPV mode Single press to select
NIPPV Dual limb Selects the code panel for
Single press to select or cancel Screen Calibration screen calibration mode
Selects NHFOV mode Single press to select
NHFOV Dual limb only Activates Patient log export
Single press to select or cancel
Patient Log
utility
Selects O2 therapy mode Requires USB memory stick to be
O2 Therapy Single limb only inserted. Single press to select
Single press to select or cancel
Activates Events log export
Selects Standby mode Events Log
utility
Standby Requires USB memory stick to be
Single press to select or cancel
inserted. Single press to select
Rapid scroll up Activates Screen captures
Single press to select Screen captures export utility
Single press to select
Slow scroll up
Single press to select Starts the selected data
export.
Slow scroll down Start Export Single press to select - only active
Single press to select when USB memory stick present
and in standby mode.
Rapid scroll down
Cancels the selected data
Single press to select
export.
Single press to select - only active
Loudness % Cancel
60% when USB memory stick present, in
Single press to select or cancel
standby mode and export in
progress.
Selects the flow sensor
Flow Sensor calibration Returns user to Data tab.
Single press to select Single press to select - only active
OK when USB memory stick present, in
Starts the calibration routine standby mode and export complete.
Start Calibration
Single press to select Times out after 3 seconds

161
Technical data

Button Description Button Description

Selects the waveforms - Decrease setting


Single press to select
layout
Single press to select
Selects 10 mm patient circuit
ventilation
Selects the loops layout Single press to select
Single press to select

Selects 15 mm patient circuit


ventilation
Selects the trends layout
Single press to select
Single press to select

Opens the selected layout Additional


Parameters Activates all additional
Edit tab
parameters
Single press to select
Single press to select or cancel
Toggles between On & Off
ON Single press to select or cancel
Manual
Selects the pressure Breath Activates a manual breath
Pressure waveform Single press to select
Single press to select

Flow
Selects the flow waveform
Single press to select Inspiratory Activates an inspiratory hold
Hold Single press to select or button can
Selects the volume be held for a a maximum of 5 or 10
Volume waveform seconds depending on user set
Single press to select preference.

F/V
Selects the flow/volume loop
Single press to select
Activates an oscillatory sigh
Selects the flow/pressure Sigh Single press to select
F/P loop
Single press to select
Selects the volume/pressure Activates an oscillatory sigh
V/P loop hold
Single press to select Single press to select or button can
Sigh
be held for a a maximum of 5 or 10
Selects the trend drop down seconds depending on user set
menu preference.
Single press to select
OxyGenie
Confirm setting button Activates OxyGenie
Single press to select Single press to select..
(91-95%)

Cancel/Exit button Activates an oscillatory


Single press to select Oscillation
pause.
Pause
Activates the trend zoom Press and hold for 2 seconds
Zoom function Pauses the waveforms
Single press to select or cancel Single press to select
Press and hold for 1 second to
Cursor Activates the trend cursor Si h activate screen capture.
Single press to select or cancel
Releases the paused
Activates the trend scroll waveforms
Scroll function Single press to select
Single press to select or cancel Press and hold for 1 second to
Si h
activate screen capture.
Increase setting
+ Single press to select

162
Technical data

Button Description Tabs Description


Save screen capture to History tab
memory History Tab allows access to alarm history.
Press and hold for 3 seconds to Single press to select
activate screen capture Loudness tab
Number keys 0 to 9 Loudness Tab allows access to alarm
1 Single press to select
loudness adjustment tab.
Single press to select
Backspace - Cancels input Sensors tab
Single press to select Tab allows access to sensor
Sensors
Back button - returns to calibration tab.
<< Back Single press to select
previous tabs
Single press to select Brightness tab
Brightness Tab allows access to screen
Alarm audio pause brightness adjustment tab.
Single press to select or cancel Single press to select
System tab
System Tab allows access to system
functions tab.
Single press to select
Data tab
Data Tab allows access to data tab.
Single press to select

26.4.2.3 Controls
Measured values The following Controls are available via the touch
Press and hold for 1 second to screen:
toggle between single and double
column values. Controls Description
Ti
Ti (Inspiratory time) control
Range 0.1 - 3.0 seconds
Single press to select or cancel
Seconds

Ti Max
Ti Max (Maximum inspiratory
time) control
26.4.2.2 Tabs Range 0.1 - 3.0 seconds
The following Tabs are available via the touch Single press to select or cancel
Seconds
screen:
CPAP
Tabs Description CPAP control
Range 0.0 - 35 mbar
Invasive mode tab
Single press to select or cancel
Invasive Tab allows access to Invasive
mbar
modes and circuit size selection.
Single press to select
PEEP
Non-Invasive mode tab PEEP control
Non-Invasive Tab allows access to Non-invasive Range 0.0 - 35 mbar
modes. Single press to select or cancel
Single press to select
mbar

Standby mode tab


Tab allows access to Standby PIP
mode. PIP control
Standby
Standby mode only active when Range 1 - 65 mbar
ventilating. Single press to select or cancel
Single press to select mbar

Limits tab
Tab allows access to alarm limits.
Limits Alarm limits only active when
ventilating.
Single press to select

163
Technical data

Controls Description Controls Description

O2 Frequency
Oxygen % control Frequency control
Range 21 - 100 % Range 3 - 20 Hz
Single press to select or cancel Single press to select or cancel
% Hz

RR Backup
RR Backup (Respiratory I:E I:E (Inspiratory to expiratory
rate) control ratio) control
Range 1 - 150 BPM Range 3 - 20 Hz
Single press to select or cancel Single press to select or cancel
BPM Ratio

Rise Time Sigh RR Sigh RR (Sigh respiratory


Rise time control rate) control
Range 1 - 150 BPM Range 1 - 150 BPM
Single press to select or cancel Press and hold for 2 seconds to
Seconds BPM select

Trig Sens Trig Sens (Trigger Sigh Ti


Sigh Ti (Sigh inspiratory
sensitivity) control time) control
Range 1 - 150 l/min With flow sensor
Range 1 - 100 % Without flow sensor
Range 0.1 - 3.0 seconds
Single press to select or cancel Single press to select or cancel
l/min seconds

RR Sigh P Sigh P (Sigh pressure)


RR (Respiratory rate) control
Range 1 - 150 BPM control
Single press to select or cancel Range 0 - 45 mbar
Single press to select or cancel
BPM mbar

Term Sens
Term Sens (Termination
sensitivity) control
Range 5 - 50 %
Single press to select or cancel
%

VTV (Volume targeted


VTV
ventilation) control
Vte Target when on.
Range 2 - 300 ml
Press and hold for 2 seconds to
ml
select

P Support
P Support control
Range 0 - 65 mbar
Press and hold for 2 seconds to
select
mbar

ΔP
ΔP (Delta pressure) control
Range 4 - 180 mbar
Single press to select or cancel
mbar

MAP
MAP control
Range 0 - 45 mbar
Single press to select or cancel
mbar

164
Technical data

26.5 Measurement 26.5.6 Pressure controlled breath accuracy


(Non-invasive Ventilation)
26.5.1 Flow sensor PIP
Flow Sensor Type: . . 10 mm dual-hot-wire Maximum Bias error: . . . ±1 mbar
anemometer.
Maximum linearity error: . ±18 %
Applied part: . . . . . . . Type BF
PEEP
Flow Rate: . . . . . . . . . 0.2 l/min to 30 l/min
Maximum Bias error: . . . ±1 mbar
Accuracy: . . . . . . . . . ±8 % maximum
Maximum linearity error: . ±18 %
Dead space: . . . . . . . 1 ml
Oxygen
Weight: . . . . . . . . . . . 10 g
Maximum Bias error: . . . ±3 %
26.5.2 Flow Maximum linearity error: . ±0.5 %
Flow Rate: . . . . . . . . 0 l/min to 99 l/min
26.5.7 Measured parameters
Resolution: . . . . . . . . 0.1 l/min
Leak
26.5.3 Volume Measurement range: 0 to 99%
Expiratory Tidal Volume: Resolution: . . . . . . . . 1%
0 to 999 ml (0.1 ml) Percentage leak measured around ET tube (when
Expiratory Minute Volume: using an un-cuffed tube). The difference between
0 to 18 L the expired volume compared to the inspired
Resolution: . . . . . . . . 1 ml volume as a percentage and averaged over 5
breaths. A calculated value.
26.5.4 Volume controlled breath accuracy
Value smoothed with a filter (time constant equal to
Volume 10 breaths).
Maximum Bias error: . . . .±3 ml
Maximum linearity error: .±8 % Respiratory Rate (RR)
Measurement range: 0 to 999 BPM
PEEP Resolution: . . . . . . . . 1 BPM
Maximum Bias error: . . . .±1 mbar Total number of breaths detected by the ventilator.
(Mechanical and patient triggered). A measured
Maximum linearity error: .±18 %
value.
Compliance (C)
Oxygen
Measurement range: 0 to 99.9 ml/mbar
Maximum Bias error: . . . .±3 %
Resolution: . . . . . . . . 1ml/mbar
Maximum linearity error: .±0.5 %
Compliance is the ratio of the change in lung
volume to change in the applied pressures. A
26.5.5 Pressure controlled breath accuracy calculated value. Value smoothed with a filter (time
(Invasive Ventilation) constant equal to 3 breaths).
PIP C20/C:
Maximum Bias error: . . . .±1 mbar Measurement range: 0 to 9999.9
Maximum linearity error: .±11 % Resolution . . . . . . . . 0.1
Sampling Time: . . . . 2ms
PEEP Is the ratio of the compliance during the last 20% of
Maximum Bias error: . . . .±1 mbar the respiratory cycle to the total compliance. A
Maximum linearity error: .±18 % calculated value. Value smoothed with a filter (time
constant equal to 3 breaths).
Oxygen Resistance (R)
Maximum Bias error: . . . .±3 % Measurement range: 0 to 999 mbar l/second
Maximum linearity error: .±0.5 % Resolution . . . . . . . . 1
Resistance of the patient lung to flow The total
change in the applied pressure to the patient lung
divided by the peak expiratory flow from the lung. A
measured value.

165
Technical data

Value smoothed with a filter (time constant equal to Measurement range: 0 to 9.9 kPa
3 breaths). Resolution: . . . . . . . . 0.1 kPa
Inspiratory time (Ti). End-tidal CO2. A measured value.
Measurement range: . 0 to 9.99 seconds % volume
Resolution: . . . . . . . . 10 milliseconds Measurement range: 0 to 100 %
The measured inspiratory time, where the breath Resolution: . . . . . . . . 1 %
may be flow or volume terminated and therefore SpO2
shorter than the set inspiratory time. Measurement range: 0 to 100 %
Expiratory time (Te) Resolution: . . . . . . . . 1 %
Measurement range: . 0 to 9.99 seconds Peripheral capillary oxygen saturation. A measured
Resolution: . . . . . . . . 10 milliseconds value.
The measured expiratory time, Total respiratory rate PR (Pulse rate)
minus the Inspiratory time. A calculated value. Measurement range: 0 to 999 Pulses per minute
Vmin (l) Resolution: . . . . . . . . 1 Pulse
A measured value.
Measurement range: . 0 to 99.99 l
Resolution: . . . . . . . . 0.01 l PI (Perfusion index)
Minute volume is the accumulated expiratory tidal Measurement range: 0 to 99 %
volume over a one-minute period. A measured
Resolution: . . . . . . . . 0.1
value in litres per minute.
A calculated value.
Trigger (Trig)
26.5.7.1 Oxygen Concentration
Resolution: . . . . . . . . 1 Measurement range: 0% to 999%
The number of patient triggered breaths (updated Resolution: . . . . . . . . 1%
every 2 seconds). A measured value. Accuracy: . . . . . . . . . ±3%
Vte (ml) Response time: . . . . 45 seconds
Measurement range . 0 to 99.9 ml 26.5.7.2 Pressure
Resolution: . . . . . . . . 0.1 ml Peak Pressure: . . . . 0 to 999mbar
Expired volume of large and small breaths. A Resolution: . . . . . . . . 0.1 mbar
measured value in millilitres. Value smoothed with a Accuracy: . . . . . . . . . ±0.75% of full scale
filter (time constant equal to 3 breaths). A measured value
DC02
PEEP Pressure: . . . 0 to 999 mbar
Measurement range . 0 to 9999 Resolution: . . . . . . . . 0.1 mbar
Resolution . . . . . . . . . 1 Accuracy: . . . . . . . . . ±0.75% of full scale
Is a gas transport coefficient. A calculated value A measured value
based on tidal volume and frequency. Value
smoothed with a filter (time constant equal to 3 Mean Pressure: . . . . -999 to 999 mbar
breaths). Resolution: . . . . . . . . 0.1 mbar
I:E Ratio Accuracy: . . . . . . . . . ±0.75% of full scale
A measured value
Measurement range . 1:9.9 or 9.9:1
Resolution . . . . . . . . . 0.1 Delta P:
Inspiratory to Expiratory ratio. A calculated value Mean Pressure: . . . . 9 to 999 mbar
derived from the user set inspiratory time against Resolution: . . . . . . . . 1 mbar
the time divided by the user set BPM minus the In HFO combined mode Delta P is measured during
inspiratory time. expiration only. A measured value.
etCO2 Above values are obtained under ATPD (ambient
mmHg temperature and pressure, dry) conditions.
Measurement range: . 0 to 99.9 mmHg
26.5.7.3 Trends
Resolution: . . . . . . . . 0.1 mmHg Trend data logged at 1 Hz
Kpa

166
Technical data

26.5.7.4 Sound pressure level 26.5.9 Measurement uncertainties


Sound pressure level: 49 dBA Below are listed the measurement uncertainties for
Sound power level: . . 53 dBA following monitored variables:
26.5.7.5 Exhalation Block Port Jet Sizes Flow . . . . . . . . . . . . . . . . ±2%
Reverse or negative jet: Pressure . . . . . . . . . . . . . ±0.5%
Ø 1.45/1.5 mm Oxygen concentration . . ±2%
Forward or positive jet:
Ø 1.25/1.3 mm 26.6 Patient circuits
Mean or 3rd jet: . . . . Ø 0.60/1.0 mm
Ø 10 mm . . . . . . . . . BC6188
26.5.8 BS EN ISO 80601-2-12 Disclosure Resistance:. . . . . . . . @15 l/min 1.5 mbar
Volume controlled breaths Resistance:. . . . . . . . @30 l/min 6 mbar
Compliance: . . . . . . . 1.89 ml/kPa/m
As per the above standard, Clause 201.12.1.101
Inspiratory and expiratory pressure drop
Volume-controlled breath type, maximum
inaccuracies are contained within the tolerances 5 l/min. . . . . . . . . . . . 0.8 mbar
stated in Section 26.5.4 of this document. 2.5 l/min . . . . . . . . . . 0.38 mbar

With reference to Note 3 of Clause 201.12.1.101


Ø 10 mm . . . . . . . . . BC6188/DHW
Intentionally, for some of these tests, i.e., those with Resistance:. . . . . . . . @15 l/min 1.5 mbar
a large compliance and a large resistance, the end Resistance:. . . . . . . . @30 l/min 6 mbar
expiratory flow will not reach zero.
Compliance: . . . . . . . 1.89 ml/kPa/m
In these cases the actual delivered volume and the Inspiratory and expiratory pressure drop
value in table 201.103 (within BS EN ISO 80601-1- 5 l/min. . . . . . . . . . . . 1.50 mbar
12) the following differences are recorded: 2.5 l/min . . . . . . . . . . 0.25 mbar
Volumes of 50 ml and the O2% set to 60% (Circuit
compliance 3 ml/hPa, resistance 200 hPa/l/s, BPM Ø 15 mm . . . . . . . . . BC6198
30 and Ti of 0.6 sec.) inaccuracy rises to ±12%. Resistance:. . . . . . . . @15 l/min 0.3 mbar
PEEP at volumes of 20 ml and the O2% set to 30% Resistance:. . . . . . . . @30 l/min 1.0 mbar
(Circuit compliance 1 ml/hPa, resistance 200 hPa/l/ Compliance: . . . . . . . 3.72 ml/kPa/m
s, BPM 60 and Ti of 0.4 sec.) inaccuracy rises to Inspiratory and expiratory pressure drop
±38%. 5 l/min. . . . . . . . . . . . 0.15 mbar
Pressure controlled breaths 2.5 l/min . . . . . . . . . . 0 mbar

As per the above standard, Clause 201.12.1.102 26.7 Breathing system filters
Volume-controlled breath type, maximum
26.7.1 N3029
inaccuracies are contained within the tolerances
stated in Section 26.5.5 of this document. Filtration Efficiency: . BFE 99.999% VFE 99.992%
Resistance
With reference to Note 3 of Clause 201.12.1.102
@ 30 l/min: . . . . . . . . 160 pa
Intentionally, for some of these tests, i.e., those with Dead space: . . . . . . . 65ml
a large compliance and a large resistance, the end Connections: . . . . . . 22M/15F-22F/15M
expiratory flow will not reach zero. Weight: . . . . . . . . . . . 40gm
In these cases the actual delivered volume and the Autocalve cycles: . . . 5
value in table 201.104 (within BS EN ISO 80601-1-
12) the following differences are recorded:

PIP at 15 mbar and the O2% set to 30% (Circuit


compliance 20 ml/hPa, resistance 20 hPa/l/s, BPM
20 and Ti of 1 sec.) inaccuracy rises to ±11%.

PEEP at 5 mbar and the O2% set to 30% (Circuit


compliance 3 ml/hPa, resistance 50 hPa/l/s, BPM
30 and Ti of 0.6 sec.) inaccuracy rises to ±34%.

167
Technical data

26.7.2 N3587 26.9.2.1 Connectors


Filtration Efficiency: . . BFE 99.99% VFE 99.99% P/Nº Z6000/NST
Resistance Air connector . . . . . . NIST (ISO 18082:2014)
@ 30 l/min: . . . . . . . . 49.5pa Oxygen connector . . NIST (ISO 18082:2014)
Dead space: . . . . . . . 30 ml P/Nº Z6000/DIS
Connections: . . . . . . . 22M/15F-22F Air connector . . . . . . DISS
Weight: . . . . . . . . . . . 23gm Oxygen connector . . DISS

26.7.3 N3588 26.9.3 Flows


Filtration Efficiency: . . BFE 99.99995% VFE Variable Fresh Gas Flow:
99.99985% 2 to 30 l/min
Resistance Resolution: . . . . . . . . 1l/min
@ 30 l/min: . . . . . . . . 76 pa Maximum gas flow:. . 85 l/min
Dead space: . . . . . . . 30 ml Resolution: . . . . . . . . 1 l/min
Connections: . . . . . . . 22M/15F-22F/15M Nebulizer flow: . . . . . 7 l/min
Weight: . . . . . . . . . . . 25gm Resolution: . . . . . . . . 1l/min

26.8 Maximum limited Pressures


Conventional PLIM . . . 120 mbar (single fault 26.10 Service life
condition) The SLE6000 has a 10 year service life from the
date of commissioning.
26.9 Gas supplies
26.11 Power, Dimensions, Classification
The air and oxygen high pressure gas supplies are
used as fresh gas. 26.11.1 Power AC
26.9.1 Oxygen supply Mains Voltage: . . . . . 100-240V/ 50-60Hz Power:
115 VA
The ventilator requires a supply of medical grade
oxygen between 2.8 to 6 bar. Fuse: . . . . . . . . . . . . T2.5AH 250V (5x20mm)
(Qty 2)
26.9.2 Air supply The ventilator will typically run for over 3 hours from
The ventilator requires a supply of medical grade 100% battery charge to complete discharge, both in
compressed air to ISO8573.1 Class 1.4.1 (minimum conventional and HFO modes. Actual battery
level of filtration) between 2.8 to 6 bar discharge duration will depend on battery condition
and ventilation settings applied.
Recommended level of filtration is class 1.1.1.
Battery Charging: . . Full charge 18 Hours 80%
Description of Class 1.4.1 charge 8 hours
1= Maximum number of particles per cubic metre as 26.11.2 Power DC
a function of particle size.
Voltage: . . . . . . . . . . 24V 4A (Requires a medical
From 0,1 μm to 0,5 μm : < 20 000
grade power supply)
From 0,5 μm to 1,0 μm : < 400
From 1.0 μm to 5.0 μm : < 10 Connector: . . . . . . . . EN3 series 2. 2 way male
4 = Pressure dewpoint of +3 ºC. connector. (Switchcraft
EN32F16X)
1= oil content 0.01mg/m3

Description of Class 1.1.1

1= particle size of 0.1 microns.


1 = Pressure dewpoint of -70 ºC.
1= oil content 0.01mg/m3

If the compressed air supply is found to fall below


the ISO8573.1 standard then in-line filtration of the
air is required.

168
Technical data

26.12 Operating Environment


Temperature: . . . . . . +10ºC to +40ºC
Relative Humidity: . . 10 to 90% (Non condensing)
Ambient pressure: . . 620 mbar (4000m) to 1060
mbar (Sea level)
Size, Ventilator only: . 330 mm W x 369 mm H x 548
mm D
Height on pole: . . . . . 1310 mm
Weight (ventilator): . . 22Kg
Note: The ventilator maintains the accuracy of
controlled and displayed variables when
operating within the above stated limits of
temperature, humidity and ambient pressure.

26.12.1 Connectors
Exhalation port: . . . . . 15 mm (F) /22 mm (M)
Conical to ISO5356-1
Proximal Airway: . . . . 5 mm Non Conical
Fresh Gas Port:. . . . . 15 mm (M)
Conical to ISO5356-1
Nebulizer port:. . . . . . 5 mm Non Conical

26.13 Classification (Electrical)


Type of protection against electric shock: Class I.

Degree of protection against electric shock: Type


BF applied part.

Unit must be earthed.

26.14 GMDN classification number


GMDN: . . . . . . . . . . . 14361

26.15 IP rating
Type of protection against ingress of water: IP21

First digit 2: Protected against solid foreign objects


of 12,5 mm in diameter and greater

Second digit 1: Protection against vertically falling


water drops.

26.16 Environmental Storage Conditions


When packed for transport or storage;

Ambient Temperature:
-20°C to +50°C
Relative Humidity: . . . 10% to 90% non-condensing
Atmospheric Pressure:
500 mbar to 1060 mbar

169
Technical data

27. Output ports (Electrical) 27.2.2.2 Data Format


Data within the SLE6000 basic data output is
27.1 RS232 port implemented as a comma delimited ASCII string
format. All valid data is represented using
The SLE6000 has two versions of data output alphanumeric characters. Characters are used to
represent data which is out of range or invalid for a
Basic data output (V2.0) listed below or Enhanced
different reason and will be used in place of the
data output (V3.0)
parameter value.
See “SLE6000 enhanced data output (V3.0)” on
Character(s) Use case Description
page 176. for description.
‘?’ Invalid data Data which is
unknown or has
27.2 SLE6000 basic data output (V2.0). timed out will be
The SLE6000 basic data output is the default replaced by ‘?’.
protocol used to output data from the ventilator to an ‘-‘ Data is out of range Each data has an
external medical monitor. associated range.
Data which is out of
The data is a comma delimited ASCII string of 63 this range is
device parameters. replaced by ‘-‘
‘,’ Separation of
27.2.1 SLE6000 basic data output specifications parameters
(V2.0) <CR><LF> End of output string Carriage return,
SLE6000 basic data output contains a Header, Data Line Feed. Used to
indicate the end of a
and Footer format. data transmission
Header Data Footer
Device ID, 63 Parameters, Comma CRC, Carriage
27.2.3 Data Layout
Version, separated Return, Line An example of the output is shown below. The
Pressure Units, Feed header and footer sections are shown in bold the
Number of data is in italics.
Parameters

The data is output at a fixed baud rate, with no


parity bits or hardware handshaking in use. The
protocol is a unidirectional protocol and does not
require a response from the connected medical
monitor. The protocol does not allow for
transmission of data by the medical display monitor;
any data received by the SLE6000 ventilator will be
ignored.
Header Format
27.2.2 Communications Settings (V2.0)
Parameter Name Description Value
The SLE Protocol is transmitted using an RS232
Ventilator ID Unique to each type of SLE6000
format, with a fixed baud rate. The communication ventilator. i.e. “SLE6000”
interface uses the following RS232 settings:
Version ID Protocol Version ID V2.0
Setting Type Value Pressure Units The units of all displayed ‘0’ - mbar,
Baud Rate 19,200 bps pressure values. mbar or ‘1’ - cmH2O
cmH2O
Parity None
Parameter The number of 63
Data Bits 8 Number parameters output.
Stop Bits 1
Data Format ASCII Text String Footer Format
Flow Control None Description Number of Characters Range
CRC Value 4 0000 – FFFF
27.2.2.1 Data Rate & Size (V2.0)
The transmission of the data string begins every 1 Carriage Return 1 <CR> (0x0D)
second. The maximum size of each ASCII string is Line Feed 1 <LF> (0x0A)
512 bytes.

170
Technical data

27.2.4 Data Format The validity of each parameter is checked before


The data contains 63 parameters which are transmission by the SLE6000 ventilator.
outputted in a fixed order. Each parameter has a
defined limit and scaling. Each parameter is output Note: If the Pressure Units parameter is
in integer format. unknown, then all pressure related
parameters are replaced by the invalid data
character.

Nº Name Description Units Output Range (Physical range)


1 – 150
Set Respiratory Rate (Breaths per
1 RR Breaths/min
minute).
0 if RR backup is OFF
2 CPAP Set CPAP value. 0.1 * pressure units 0 – 350 (0 – 35 mbar or cmH2O)
10 – 1500
(2 – 300ml)
3 Tidal Volume Set Target Tidal Volume 0.2ml 15 – 1500
(3 – 300ml) with etCO2 sensor
connected
10 – 300
4 Ti Set Target inspiratory time 0.01s
(0.10 – 3.00s)
0 – 65 (mbar or cmH2O)

Pressure Unit 2 – 25 (mbar or cmH2O ) in nCPAP


5 PIP Set PIP Pressure
(1 mbar or 1 cmH2O) S, DuoPAP

Sigh P value in HFOV, nHFOV


6 O2 Set Oxygen Concentration % 21 – 100
7 HFO Delta P Set HFO Delta P Pressure Unit 4 – 180 (mbar or cmH2O)
8 HFO MAP Set HFO Mean Pressure Pressure Unit 0 – 45 (mbar or cmH2O)
9 HFO Frequency Set HFO Rate 0.1Hz 30 – 200 (3.0 – 20.0Hz)
Backup Respiratory rate in HFO 0 – 150
10 Sigh RR Breaths/min
mode ‘-‘if sigh cycling is not enabled.
Inspiratory time in HFO mode, for 10 – 300 (0.10 – 3.00s)
11 Sigh Ti 0.01s
Sigh breaths ‘-’ if sigh cycling is not enabled.
Pressure applied in Sigh breaths, 0 – 45 (mbar or cmH2O)
12 Sigh P Pressure unit
HFO mode. ‘-‘if sigh cycling is not enabled.
Uses the Breath mode enumerated
list:
CPAP = 0
CMV = 1
PTV =2
PSV = 7
SIMV =3
HFO only = 4
13 Ventilation Mode n/a n/a HFO + CMV = 5
nCPAP D= 9
NIPPV (Dual limb)= 10
NIPPV Tr = 11
NHFOV (Dual limb)= 12
NCPAP (Single limb)=13 DuoPAP
=14
O2 Therapy = 16
Standby = 17
0 = OFF.
14 VTV Status N/A N/A
255 = ON.
Set % of breath maximum flow 5 – 50
15 Termination Sensitivity %
which triggers breath termination. ‘-’ when OFF
0.1Lpm for low
triggering. 2 – 200
16 Breath Trigger Threshold Target trigger threshold If Pressure triggered (0.2 – 20 l/min for flow triggering. 1 –
then 0.5% 100% for Pressure Triggering)

171
Technical data

Nº Name Description Units Output Range (Physical range)


17 Time taken for pressure curve to
Rise Time 10ms 0 – 300 (0.00 – 3.00s)
reach 99% of the target pressure
18 Expiratory port flow whilst in O2 50 – 300 (5.0 – 30.0l/min)
Set Flow (O2 Mode) 0.1 l/min
support mode.
19 Nebuliser is connected and ON/OFF 255 = ENABLED
Nebuliser Enabled
enabled. 0 = DISABLED
20 5 – 50
Patient Leak alarm Leak alarm value % ‘-‘ when OFF

21 Time taken to trigger the apnoea 5 – 60


Apnoea Alarm Seconds
alarm ‘-‘ when Apnoea alarm is turned off
22 Value to trigger a low pressure -2200 – 1100 (-220 – 110 mbar or
Low pressure alarm 0.1 * Pressure Unit
alarm cmH2O)
23 0 – 450 (0 – 45.0 mbar)
High PEEP Alarm High PEEP alarm threshold. 0.1*Pressure Unit
1– 450 (1 – 45.0 cmH2O)
24 Cycle Fail alarm Cycle Fail alarm threshold. 0.1 * Pressure Unit 0 – 640 (0 – 64 mbar or cmH2O)
25 High PIP Alarm
Value to trigger a high pressure 10 – 1750 (1 – 175 mbar)
High Paw alarm in HFOV, 0.1 * Pressure Unit
alarm 50 – 1750 (5 – 175 cmH2O)
HFOV+ CMV and nHFOV
26 Value to trigger a low tidal volume 0 – 3950
Low tidal volume alarm 0.1ml
alarm (0 – 395ml)
27 Value to trigger a high tidal 10 – 4000
High tidal volume alarm 0.1ml
volume alarm (1 – 400ml)
28 Value to trigger the minute volume 0 – 17900
Low minute volume alarm ml
alarm (low) (0 – 17.90l)
29 Value to trigger the minute volume 10 – 18000
High minute volume alarm ml
alarm (high) (0.01l – 18l)
30 Low end tidal CO2 concentration etCO2 Units (as shown
Low etCO2 Alarm 0 – 145
alarm in parameter 54)
31 High end tidal CO2 concentration etCO2 Units (as shown
High etCO2 Alarm 5 – 150
alarm in parameter 54)
32 Low spO2 Alarm Low spO2 Concentration Alarm % 1 – 98
33 High spO2 Alarm High spO2 Concentration Alarm % 2 – 99 and ‘-‘ when OFF
34 Low Pulse Rate Alarm Low pulse rate alarm Beats/min 30 – 230
35 35 – 235
High Pulse Rate Alarm High pulse rate alarm Beats/min
‘-‘ when OFF
36 Measured RR (Respiratory Total breath count over the last
Breaths/min 0 – 255
Rate) minute
37 - 1 – 32767
(-0.1 – +3276.7 mbar)
Measured CPAP Measured CPAP value 0.1 * pressure units
- 1 – 32767
(-0.1 – +3276.7 cmH2O)
38 0 – 9900
Measured Ti Measured inspiratory time. 0.01s
(0.00 –99.0s)
39 0 – 32767
Measured Vinsp Measured inspiratory volume 0.1ml
(0 – 3.2767l)
40 0 – 32767
Measured Vte Measured expiratory volume 0.1ml
(0 – 3.2767l)
41 - 1 – 32767
(-0.1 – +3276.7 mbar)
Measured PEEP Measured PEEP value 0.1 * Pressure Unit
- 1 – 32767
(-0.1 – +3276.7 cmH2O)
42 - 1 – 32767
(-0.1 – +3276.7 mbar)
- 1 – 32767
Measured PIP Measured PIP value 0.1 * Pressure Unit
(-0.1 – +3276.7 cmH2O)

172
Technical data

Nº Name Description Units Output Range (Physical range)


Measured oxygen concentration 18– 100
43 Oxygen Concentration %
as a % of the air composition ‘-‘ during O2 Calibration
The difference between maximum
44 Measured HFO Delta P and minimum pressures in HFO Pressure Unit 0 – 255
mode.
-2200 – 1100
(-220 – +110 mbar)
45 Measured HFO MAP Measured HFO mean pressure 0.1* Pressure Unit
- 2200 – 1100
(-220 – +110 cmH2O)
Number of breaths triggered by
46 Trigger Count Breaths/min 0 – 255
the patient in the last minute
Measured volume change in the
47 Measured Minute Volume ml 0 – 18900l (0.00 – 18.9l)
last minute
Measured % of air leaking from
48 Leak % 0 – 99
the system
0.1 (mbar or mmH20/s/ 0 – 9990 (0 – 999 mbar/l/s or
49 Resistance Measured airway resistance
litre) cmH2O/l/s)

Measured dynamic airway 0.1 ml/mbar (0.1 ml/ 0 – 254 (0.0 – 25.4 ml/mbar or ml/
50 Compliance
compliance Pressure Unit) cmH2O)
The ratio of the compliance over
51 C20/C the last 20% of the pressure rise 0.1 0 – 99 (0.0 – 9.9)
compared to total compliance
52 DCO2 Gas transport coefficient 1 0 – 65534
53 etCO2 Measured End tidal CO2 pressure mmHg 0 – 150 (mmHg)
0 = mmHg,
54 etCO2 Units etCO2 Pressure Units N/A 1 = Volume Percentage,
2 = kPa
55 SpO2 Oxygen saturation 0.1% 0 – 250 (0.0 – 100.0%)
56 Pulse Rate Pulse rate Beats/minute 25 – 239
57 PCO2 Carbon Dioxide partial pressure mmHg 0 – 2000 (0.0 – 200.0 mmHg)
58 PO2 Oxygen partial pressure mmHg 0 – 2000 (0.0 – 200.0 mmHg)
59 Unassigned N/A N/A ‘-‘
60 Unassigned N/A N/A ‘-‘
61 Unassigned N/A N/A ‘-‘
62 Unassigned N/A N/A ‘-‘
The current active alarm. See
63 Alarm Status N/A See Alarm Table
(Table 6)

173
Technical data

Alarm Table Alarm


Alarm Description
Code
Alarm 62 No O2 Supply
Alarm Description
Code
1 O2 sensor disconnected. Please reconnect. 63 No Air Supply

2 The oxygen cell needs calibrating. 64 No Gas.

3 A new oxygen cell is required. 68 User interface has reset. Confirm settings.

4 O2 calibration fail 71 Controller system error. Restart ventilator.

5 High Oxygen Level. 72 Controller hardware error. Restart ventilator.

6 Low Oxygen level. 73 Alarm system failure. Remove ventilator from use.
Check data output.
15 Pressure sensor fault. Remove ventilator from use.
75 Note: The alarm changes to Status message when
16 High Pressure Threshold Exceeded. reset.
80 Sub Ambient Pressure - 1
17 Low Pressure
81 Sub Ambient Pressure - 2
18 Apnoea.
82 Flow Sensor Clipping
19 Cycle Fail.
83 Flow Sensor Reversed
20 Continuing Positive Pressure
90 Unexpected Rise in Mean Pressure
21 High CPAP
91 Unexpected Drop in Mean Pressure
22 High PEEP
96 Pressure change detected.
23 High PIP
97 Unexpected Rise in Delta Pressure.
24 Low PIP
Monitor isolated communication error. Restart 98 Unexpected Drop in Delta Pressure.
25
ventilator.
99 High PAW
26 Monitor isolated system error. Restart ventilator.
Internal communication fault. Remove ventilator from
Unable to calibrate Flow ADC. 100
27 use.
Note: applicable for Engineering Utility System Fail 101 (Memory Checksum Error) –
101
28 Calibrate Flow Sensor. redundant alarm
System Fail 102 (Memory Checksum Error) –
102
29 Unable to calibrate flow sensor. redundant alarm
System Fail 103 (Memory Checksum Error) –
30 Flow sensor is not connected. 103
redundant alarm
System Fail 104 (Memory Checksum Error) –
31 Flow sensor is defective. 104
redundant alarm
32 Flow sensor is contaminated. System Fail 105 (Memory Checksum Error) –
105
redundant alarm
40 Alarm system failure. Remove ventilator from use. Ventilator out of calibration. Remove ventilator from
106
use.
41 Not used in V2.0.90
Power supply error.
45 Battery low. 114 Note: Whenever the monitor sub system fails to
communicate with the power supply a resettable
46 Main Power Fail.
115 Power supply fault. Remove ventilator from use.
47 Battery fault. Remove ventilator from use.
116 Monitor hardware fault. Remove ventilator from use.
48 Battery low.
117 Monitor hardware fault. Remove ventilator from use.
50 High Minute Volume
Power supply fault. Restart ventilator.
51 Low Minute Volume 118 Note: When the “Power supply error.” alarm is activated
for more than 5 occurrences, the message changes to
52 Low Tidal Volume
120 High Respiratory Rate
53 High Patient Leak.
255 UI internal communication error. Restart ventilator.
54 Apnoea
End tidal CO2 Alarm
55 Breath Not Detected.
151 SpO2/etCO2 Hardware Fault
56 High Tidal Volume
180 No etCO2 Module Connected
60 Blocked Fresh Gas. Check patient circuit.
181 etCO2 Module Fault - 1
61 Leaking Fresh Gas. Check patient circuit.

174
Technical data

Alarm Alarm
Alarm Description Alarm Description
Code Code
182 etCO2 Module Fault - 2 169 Low SpO2

183 etCO2 Module Fault - 3 170 High Pulse Rate


etCO2 Calibration Is Due 171 Low Pulse Rate
184
NB: Status message
etCO2 Maintenance Is Due 172 Pulse Not detected (SpO2)
185
NB: Status message No SpO2 Cable Connected (Continue without SpO2
173
186 No etCO2 FilterLine connected sensor)
84 Monitor communication error. Restart ventilator.
189 Replace etCO2 FilterLine
208 O2 > 60%
190 etCO2 Module Fault - 4
210 OxyGenie not available.
191 etCO2 Module Fault - 5
211 Oxygenie Unexpected reset
192 Invalid CO2 Value

193 CO2 value over-range

194 No etCO2 Breath

197 High etCO2

198 Low etCO2

201 High CO2

202 Low CO2

203 High etCO2 Spont


etCO2 Purge
204
NB: Status message
etcCO2 Self Maintenance Mode
205
NB: Status message
etCO2 Pump Off
206
NB: Status message
etCO2 initializing
207
NB: Status message
SpO2 Alarm

151 SpO2/etCO2 Hardware Fault

153 No SpO2 module Connected

154 No SpO2 Sensor Connected

155 SpO2 Hardware Fault - 3

156 SpO2 Hardware Fault - 1

157 Defective SpO2 Sensor - 1


Low Perfusion Index (SpO2)
158
NB: Status message
Pulse Search
159
NB: Status message
160 SpO2 Sensor Interference Detected

161 SpO2 Sensor Off Patient


Too Much Ambient Light (SpO2)
162
NB: Status message
163 Defective SpO2 Sensor - 2
Low SpO2 Signal IQ
164
NB: Status message
No SpO2 Adhesive Sensor Connected (Continue
166
without SpO2 sensor)
167 SpO2 Hardware Fault - 2

168 High SpO2

175
Technical data

27.3 SLE6000 enhanced data output 27.3.2.2 Data Format


(V3.0) Data within the SLE6000 basic data output is
implemented as a comma delimited ASCII string
The SLE6000 enhanced data output is the
format. All valid data is represented using
requested protocol used to output enhanced data
alphanumeric characters. Characters are used to
from the ventilator to an external medical monitor.
represent data which is out of range or invalid for a
The data is a comma delimited ASCII string of 70 different reason and will be used in place of the
device parameters. parameter value.
Character(s) Use case Description
27.3.1 SLE6000 enhanced data output
specifications (V3.0) ‘?’ Invalid data Data which is
unknown or has
SLE6000 basic data output contains a Header, Data timed out will be
and Footer format. replaced by ‘?’.

Header Data Footer ‘-‘ Data is out of range Each data has an
associated range.
Device ID, 70 Parameters, Comma CRC, Carriage Data which is out of
Version, separated Return, Line this range is
Pressure Units, Feed replaced by ‘-‘
Number of
Parameters ‘,’ Separation of
parameters

The data is output at a fixed baud rate, with no parity <CR><LF> End of output string Carriage return,
Line Feed. Used to
bits. The V3 protocol is predominantly a
indicate the end of a
unidirectional protocol, however it must be data transmission
requested by connected medical monitor.

To enable the V3 protocol, send the string: 27.3.3 Data Layout


An example of the output is shown below. The
SLE6000,V3.0 header and footer sections are shown in bold the
data is in italics.
This must be periodically sent by the connected
medical monitor. If not received within 30 seconds of
the last receipt, the default V2 protocol is output.

27.3.2 Communications Settings (V3.0)


The SLE Protocol is transmitted using an RS232
format, with a fixed baud rate. The communication
interface uses the following RS232 settings:
Setting Type Value
Baud Rate 19,200 bps Header Format
Parity None Parameter Name Description Value
Data Bits 8 Ventilator ID Unique to each type of SLE6000
Stop Bits 1 ventilator. i.e. “SLE6000”
Data Format ASCII Text String Version ID Protocol Version ID V3.0
Flow Control None Pressure Units The units of all displayed ‘0’ - mbar,
pressure values. mbar or ‘1’ - cmH2O
27.3.2.1 Data Rate & Size (V3.0) cmH2O
The transmission of the data string begins every 1 Parameter The number of 70
second. The maximum size of each ASCII string is Number parameters output.
512 bytes.
Footer Format
Description Number of Characters Range
CRC Value 4 0000 – FFFF
Carriage Return 1 <CR> (0x0D)
Line Feed 1 <LF> (0x0A)

176
Technical data

27.3.4 Data Format The validity of each parameter is checked before


The data contains 70 parameters which are transmission by the SLE6000 ventilator.
outputted in a fixed order. Each parameter has a
defined limit and scaling. Each parameter is output Note: If the Pressure Units parameter is
in integer format. unknown, then all pressure related
parameters are replaced by the invalid data
character.

Nº Name Description Units Output Range (Physical range)


1 RR Set Respiratory Rate/ Backup Breaths/min 1 – 150
Respiratory Rate (Breaths per
RR Backup (in CPAP, minute). 0 – 10 (nCPAP S)
nCPAP S,
nCPAP D) 0 – 60 (DuoPAP)

‘-‘ if RR Backup is Off in CPAP, nCPAP


D, nCPAP S
2 CPAP (in CPAP, nCPAP S, Set CPAP/PEEP value. 0.1 * pressure units 0 – 350 (0.0 – 35.0 mbar or cmH2O)
nCPAP D modes)

PEEP (in CMV, SIMV, PTV, 20 – 150 (2.0 – 15.0 mbar or cmH20) in
PSV, HFOV+CMV, NIPPV, nCPAP S, DuoPAP
DuoPAP, NIPPV Tr )
3 Tidal Volume Set Target Tidal Volume 0.2ml 10 – 1500
(2.0 – 300ml)

10 – 250
(2.0 – 50ml) HFOV w/o the etCO2
sensor connected

15 – 250
(3.0 – 50 ml) HFOV with the etCO2
sensor connected
4 Ti Set Target inspiratory time 0.01s 10 – 300
(0.10 – 3.00s)
Ti Max in PSV
5 PIP Set PIP Pressure Pressure Unit 0 – 65 (mbar or cmH2O)
(1 mbar or 1 cmH2O)
2 – 25 (mbar or cmH2O )
6 O2 Set Oxygen Concentration % 21 – 100
7 HFO Delta P Set HFO Delta P Pressure Unit 4 – 180 mbar or cmH2O
8 HFO MAP Set HFO Mean Pressure Pressure Unit 0 – 45 (mbar or cmH2O)
9 HFO Frequency Set HFO Rate 0.1Hz 30 – 200 (3.0 – 20.0Hz)
10 Sigh RR Backup Respiratory rate in Breaths/min 0 – 150
HFO mode ‘-’ if sigh RR is not enabled.
11 Sigh Ti Inspiratory time in HFO mode, 0.01s 10 – 300 (0.10 – 3.00s)
for Sigh breaths
12 Sigh P Pressure applied in Sigh Pressure unit 0 – 45 (mbar or cmH2O)
breaths, HFO mode.

177
Technical data

Nº Name Description Units Output Range (Physical range)


13 Ventilation Mode n/a n/a Uses the Breath mode enumerated list:
CPAP = 0
CMV = 1
PTV =2
PSV = 7
SIMV =3
HFO only = 4
HFO + CMV = 5
nCPAP D= 9
NIPPV (Dual limb)= 10
NIPPV Tr = 11
NHFOV (Dual limb)= 12
NCPAP (Single limb)=13
DuoPAP =14
O2 Therapy = 16
Standby = 17
14 VTV Status N/A N/A 0 = OFF
255 = ON
15 Termination Set % of breath maximum flow % 5 – 50
Sensitivity which triggers breath ’-‘ if P Support is OFF
termination.
16 Breath Trigger Threshold Target trigger threshold 0.1Lpm for low triggering. 2 – 200
If Pressure triggered then (0.2 – 20.0 l/min for flow triggering;
0.5% 1 – 100% for Pressure Triggering)

17 Rise Time Time taken for pressure curve 10ms 0 – 300 (0.00 – 3.00s)
to reach 99% of the target ‘-’ if not available.
pressure
18 Set Flow (O2 Mode) Expiratory port flow whilst in 0.1 l/min 20 – 300 (2.0 – 30.0 l/min)
O2 support mode.

19 Nebuliser Enabled Nebuliser is connected and ON/OFF 255 = ENABLED


enabled. 0 = DISABLED
20 Patient Leak alarm Leak alarm value % 5 – 50 = ON
‘-’ = OFF

21 Apnoea Alarm Time taken to trigger the Seconds 5 – 60


apnoea alarm ‘-’ if Apnoea alarm is turned off
22 Low pressure alarm Value to trigger a low pressure 0.1 * Pressure Unit -100 to +340 (-10 to +34 mbar or
alarm cmH20) in conventional and NIV modes
Low Paw alarm in HFOV,
HFOV+ CMV and nHFOV -650 to +340 (-65 to +34 mbar or
cmH2O) in HFOV, nHFOV

-750 to +340 (-75 to +34 mbar or


cmH2O) in HFO+CMV
23 High PEEP Alarm High PEEP alarm threshold. 0.1*Pressure Unit 10 – 450 (1 – 45 mbar or cmH2O)

High CPAP Alarm in CPAP, 10 – 250 (1- 25 mbar or cmH20) in


nCPAP D and nCPAP S nCPAP S and DuoPAP
24 Cycle Fail alarm Cycle fail alarm threshold. 0.1 * Pressure Unit 0 – 640 (0 – 64 mbar or cmH2O)

0 – 240 (0 – 24 mbar or cmH2O) in


nCPAP S and DuoPAP

178
Technical data

Nº Name Description Units Output Range (Physical range)


25 High PIP Alarm Value to trigger a high 0.1 * Pressure Unit 50 – 800 (5 – 80 mbar or cmH20) in
pressure alarm CPAP, CMV, SIMV, PTV, PSV, nCPAP D,
High Paw alarm in HFOV, NIPPV D, NIPPV Tr.
HFOV+ CMV and nHFOV
50 - 400 (5 - 40 mbar or cmH2O) in
nCPAP S, DuoPAP;

100 – 1550 (10 – 155 mbar or cmH20) in


HFOV, nHFOV;

100 – 1750 (10 – 175 mbar or cmH2O)


in HFO+CMV
26 Low tidal volume alarm Value to trigger a low tidal 0.1ml 0 – 3950
volume alarm (0 – 395ml)
27 High tidal volume alarm Value to trigger a high tidal 0.1ml 10 – 4000
volume alarm (1 – 400ml) when VTV is OFF

2 – 4000
(0.2 – 400ml) when VTV is ON
28 Low minute volume alarm Value to trigger the minute ml 0 – 17900
volume alarm (low) (0 – 17.90l)
29 High minute volume alarm Value to trigger the minute ml 10 – 18000
volume alarm (high) (0.01l – 18.00l)
30 Low etCO2 Alarm Low end tidal CO2 etCO2 Units (as shown in 0 – 145
concentration alarm parameter 54)
Low CO2 Alarm in HFOV,
HFOV+ CMV
31 High etCO2 Alarm High end tidal CO2 etCO2 Units (as shown in 5 -150
concentration alarm parameter 54)
High CO2 Alarm in HFOV,
HFOV+ CMV
32 Low spO2 Alarm Low spO2 Concentration % 1 – 98
Alarm
33 High spO2 Alarm High spO2 Concentration % 2 – 99 and ‘-‘ when OFF
Alarm
34 Low Pulse Rate Alarm Low pulse rate alarm Beats/min 30 – 230
35 High Pulse Rate Alarm High pulse rate alarm Beats/min 35 – 235
36 Measured RR (Respiratory Total breath count over the last Breaths/min 0 – 255
Rate) minute
37 Measured CPAP Measured CPAP value 0.1 * pressure units - 90 – +9990
( -9.0 – +999mbar or cmH20)
38 Measured Ti Measured inspiratory time. 0.01s 0 – 9900
(0.00 –99.0s)
39 Measured Vinsp Measured inspiratory volume 0.1ml 0 – 32767
(0 – 3.2767l)
40 Measured Vte Measured expiratory volume 0.1ml 0 – 32767
(0 – 3.2767l)
41 Measured PEEP Measured PEEP value 0.1 * Pressure Unit - 90 – +9990
(-9.0 – +999 mbar or cmH20)
42 Measured PIP Measured PIP value 0.1 * Pressure Unit - 990 – +9990
(-99.0 – +999 mbar or cmH20)
43 Oxygen Concentration Measured oxygen % 18 – 100
concentration as a % of the air ‘-‘ during O2 Calibration
composition
44 Measured HFO Delta P The difference between Pressure Unit 0 – 255
maximum and minimum
pressures in HFO mode.
45 Measured HFO MAP Measured HFO mean pressure 0.1* Pressure Unit -90 – 9990
(-9- +999 mbar or cmH2O )
46 Trigger Count Number of breaths triggered by Breaths/min 0 – 255
the patient in the last minute

179
Technical data

Nº Name Description Units Output Range (Physical range)


47 Measured Minute Volume Measured volume change in ml 0 – 18899l (0.00 – 18.9l)
the last minute
48 Leak Measured % of air leaking from % 0 – 99
the system
49 Resistance Measured airway resistance 0.1 (mbar or mmH20) /l/s 0 – 9990 (0 – 999 mbar/l/s or cmH20/l/s)
50 Compliance Measured dynamic airway 0.1 ml/mbar (0.1 ml/ 0 – 254 (0.0 – 25.4 ml/mbar or ml/
compliance Pressure Unit) cmH20)
51 C20/C The ratio of the compliance 0.1 0 – 99 (0.0 – 9.9)
over the last 20% of the
pressure rise compared to total
compliance
52 DCO2 Gas transport coefficient 1 0 – 65534
53 etCO2 Measured End tidal CO2 mmHg 0 – 150 (mmHg)
pressure
54 etCO2 Units etCO2 Pressure Units N/A 0 = mmHg,
1 = Volume Percentage,
2 = kPa
55 SpO2 Oxygen saturation 0.1% 0 – 1000 (0.0 – 100.0%)
56 Pulse Rate Pulse rate Beats/minute 25 – 239
57 PCO2 Carbon Dioxide partial mmHg 0 – 2000 (0.0 – 200.0 mmHg)
pressure
58 PO2 Oxygen partial pressure mmHg 0 – 2000 (0.0 – 200.0 mmHg)
59 Measured PI Measured Perfusion Index % 0 - 2000
(0 - 20.00 %)
Where:
PI Numeric values 0.02 – 0.99 % have
resolution +/- 0.01 %;
PI numeric values 1 – 9.9 % have
resolution +/- 0.1 % and
PI numeric values 10 – 20 % have
resolution +/- 1 %;
60 Measured SIQ Measured Signal Inadequacy % 0 – 255 (0 – 100%)
61 Measured etCO2 Spont Measured end tidal CO2 mmHg 0 – 150 (mmHg)
spontaneous value
62 Measured % Spont Measured % spontaneous % 0 – 100%
value
63 Alarm Status The current active alarm. See N/A See SLE Protocol Alarm Table (Table
(Table 6) 13)
64 Measured Fresh Gas Flow Measured value of Fresh Gas l/min 0 – 500 (0.0 – 50.0l/min)
65 High etCO2 Spont alarm High end tidal CO2 mmHg 5 – 150mmHg
spontaneous alarm
66 Auto-O2 Status Automated Oxygen status % a) Auto-O2: inactive- RS232 output is 1

b) Auto-O2: active- RS232 output is 2

c) Auto-O2: limit reached- RS232 output


is 3

d) Auto-O2: fullback mode- RS232


output is 4

e) Auto-O2: manual override- RS232


output is 5

180
Technical data

Nº Name Description Units Output Range (Physical range)


67 Set Auto-O2 target range Automated Oxygen target % There are 4 available ranges:
range set 90-94% - RS232 output is 1

91-95% - RS232 output is 2

92-96% - RS232 output is 3

94-98% - RS232 output is 4


68 Reference O2 value Reference value of Oxygen % 21 – 100%
69 Variance Co-Efficient TBC TBC TBC
(deferred)
70 Time in Range TBC TBC TBC
(deferred)

181
Technical data

Alarm Table Alarm


Alarm Description
Code
Alarm 62 No O2 Supply
Alarm Description
Code
1 O2 sensor disconnected. Please reconnect. 63 No Air Supply

2 The oxygen cell needs calibrating. 64 No Gas.

3 A new oxygen cell is required. 68 User interface has reset. Confirm settings.

4 O2 calibration fail 71 Controller system error. Restart ventilator.

5 High Oxygen Level. 72 Controller hardware error. Restart ventilator.

6 Low Oxygen level. 73 Alarm system failure. Remove ventilator from use.
Check data output.
15 Pressure sensor fault. Remove ventilator from use.
75 Note: The alarm changes to Status message when
16 High Pressure Threshold Exceeded. reset.
80 Sub Ambient Pressure - 1
17 Low Pressure
81 Sub Ambient Pressure - 2
18 Apnoea.
82 Flow Sensor Clipping
19 Cycle Fail.
83 Flow Sensor Reversed
20 Continuing Positive Pressure
90 Unexpected Rise in Mean Pressure
21 High CPAP
91 Unexpected Drop in Mean Pressure
22 High PEEP
96 Pressure change detected.
23 High PIP
97 Unexpected Rise in Delta Pressure.
24 Low PIP
Monitor isolated communication error. Restart 98 Unexpected Drop in Delta Pressure.
25
ventilator.
99 High PAW
26 Monitor isolated system error. Restart ventilator.
Internal communication fault. Remove ventilator from
Unable to calibrate Flow ADC. 100
27 use.
Note: applicable for Engineering Utility System Fail 101 (Memory Checksum Error) –
101
28 Calibrate Flow Sensor. redundant alarm
System Fail 102 (Memory Checksum Error) –
102
29 Unable to calibrate flow sensor. redundant alarm
System Fail 103 (Memory Checksum Error) –
30 Flow sensor is not connected. 103
redundant alarm
System Fail 104 (Memory Checksum Error) –
31 Flow sensor is defective. 104
redundant alarm
32 Flow sensor is contaminated. System Fail 105 (Memory Checksum Error) –
105
redundant alarm
40 Alarm system failure. Remove ventilator from use. Ventilator out of calibration. Remove ventilator from
106
use.
41 Not used in V2.0.90
Power supply error.
45 Battery low. 114 Note: Whenever the monitor sub system fails to
communicate with the power supply a resettable
46 Main Power Fail.
115 Power supply fault. Remove ventilator from use.
47 Battery fault. Remove ventilator from use.
116 Monitor hardware fault. Remove ventilator from use.
48 Battery low.
117 Monitor hardware fault. Remove ventilator from use.
50 High Minute Volume
Power supply fault. Restart ventilator.
51 Low Minute Volume 118 Note: When the “Power supply error.” alarm is activated
for more than 5 occurrences, the message changes to
52 Low Tidal Volume
120 High Respiratory Rate
53 High Patient Leak.
255 UI internal communication error. Restart ventilator.
54 Apnoea
End tidal CO2 Alarm
55 Breath Not Detected.
151 SpO2/etCO2 Hardware Fault
56 High Tidal Volume
180 No etCO2 Module Connected
60 Blocked Fresh Gas. Check patient circuit.
181 etCO2 Module Fault - 1
61 Leaking Fresh Gas. Check patient circuit.

182
Technical data

Alarm Alarm
Alarm Description Alarm Description
Code Code
182 etCO2 Module Fault - 2 169 Low SpO2

183 etCO2 Module Fault - 3 170 High Pulse Rate


etCO2 Calibration Is Due 171 Low Pulse Rate
184
NB: Status message
etCO2 Maintenance Is Due 172 Pulse Not detected (SpO2)
185
NB: Status message No SpO2 Cable Connected (Continue without SpO2
173
186 No etCO2 FilterLine connected sensor)
84 Monitor communication error. Restart ventilator.
189 Replace etCO2 FilterLine
208 O2 > 60%
190 etCO2 Module Fault - 4
210 OxyGenie not available.
191 etCO2 Module Fault - 5
211 Oxygenie Unexpected reset
192 Invalid CO2 Value

193 CO2 value over-range

194 No etCO2 Breath

197 High etCO2

198 Low etCO2

201 High CO2

202 Low CO2

203 High etCO2 Spont


etCO2 Purge
204
NB: Status message
etcCO2 Self Maintenance Mode
205
NB: Status message
etCO2 Pump Off
206
NB: Status message
etCO2 initializing
207
NB: Status message
SpO2 Alarm

151 SpO2/etCO2 Hardware Fault

153 No SpO2 module Connected

154 No SpO2 Sensor Connected

155 SpO2 Hardware Fault - 3

156 SpO2 Hardware Fault - 1

157 Defective SpO2 Sensor - 1


Low Perfusion Index (SpO2)
158
NB: Status message
Pulse Search
159
NB: Status message
160 SpO2 Sensor Interference Detected

161 SpO2 Sensor Off Patient


Too Much Ambient Light (SpO2)
162
NB: Status message
163 Defective SpO2 Sensor - 2
Low SpO2 Signal IQ
164
NB: Status message
No SpO2 Adhesive Sensor Connected (Continue
166
without SpO2 sensor)
167 SpO2 Hardware Fault - 2

168 High SpO2

183
Technical data

27.4 Vuelink & Intellibridge EC10 27.4.2 Connecting to the IntelliBridge EC10
module
Caution: Use of the alarm data communicated The SLE6000 RS232 link has been adapted for
from the RS232 port is for information only Philips IntelliBridge EC10 Interface Module.
and does not remove the need to monitor (Philips P/Nº 865115 #A01,101)
both the patient or ventilator at regular
intervals.
Connection to the monitor must be via the Philips
27.4.1 Connecting to the VueLink patient monitor IntelliBridge EC5 ID module (Philips P/Nº865114
#101 DB9) and standard ethernet cable CAT5 with
The SLE6000 RS232 link has been adapted for
RJ45 connectors to the 9-pin RS232 socket on the
Philips Open Interface/VueLink module. Connection
back of the SLE6000 ventilator. (Philips P/Nº
to the monitor must be via the VueLink module.
865114 #L02*) *(#L01 = 1.5m, #L02 = 3m & #L03
(Philips P/Nº M1032A) The module must be of the
10m)
‘Ventilator’ type.

The cable from the M1032A module (Philips P/Nº The IntelliBridge items can be purchased either
M1032-61654) requires the SLE VueLink adaptor from SLE or your Philips distributor.
(SLE P/Nº W0344) to connect it to the 9-pin RS232 The transmission speed is 19200 bps, data format 8
socket on the back of the SLE6000 ventilator. bits, 1 stop bit and no parity. All data transmitted to
the IntelliVue monitor is transferred in packets or
The transmission speed is 19200 bps, data format 8
telegrams. The IntelliVue monitor sends data
bits, 1 stop bit and no parity. All data transmitted to
request telegrams and the SLE6000 sends
the VueLink monitor is transferred in packets or
response telegrams.
telegrams. The VueLink monitor sends data request
telegrams and the SLE6000 sends response
telegrams.

W0344


SLE6000

SLE6000 EC5 ID

M1032A

M1032-61654 EC10

RJ45 cable

Module Rack

Patient

Patient onitor
onitor

184
Technical data

27.4.3 Parameter Descriptions


Default
Parameter Available
SLE 6000 Label Philips Monitor Label Param Type value to
Nº on Vuelink
display
Waveform Pressure (waveform) AWP (Airway Pressure Wave) Waveform Flat line Yes
Waveform Flow (waveform) AWF (Airway Flow Wave) Waveform Flat line Yes
Waveform Volume (waveform) AWV (Airway Volume Wave) Waveform Flat line Yes
Waveform CO2 (waveform) CO_2( Airway CO2 Wave) Waveform Flat line Yes
Waveform Pleth (waveform) SpO_2 (SPO2 Wave) Waveform Flat line Yes
AWRR (Airway Respiration rate – airway
1 Meas RR(BPM) Measurement -1 Yes
measurement)
2 AWRR (Alarm limit) High Alarm Limit -1 No
3 PIP PIP (peak inspiratory pressure in mbar) Measurement 0 Yes
4 PIP (Alarm limits) High and Low Alarm Limit 0 No
5 PEEP/CPAP PEEP (positive end expiratory pressure in mbar) Measurement 0 Yes
PEEP/CPAP (alarm
6 High and Low Alarm Limit 0 No
limits)
7 Ti InsTi (Inspiratory Time) Measurement -1 Yes
8 Texp ExpTi (Expiratory Time) Measurement -1 Yes
9 Vte TVex (Expiratory tidal volume in ml) Measurement -1 Yes
10 Vte(Alarm limits) High and Low Alarm Limit -1 No
11 Vmin MINVOL ( Minute Volume) Measurement -1 Yes
12 Vmin(Alarm limits) High and Low Alarm Limit -1 No
13 O2 inO_2 (Inspired Oxygen) Measurement 0 Yes
14 Vti TVin (Inspired tidal volume in ml) Measurement 0 Yes
HFVAmp (High freq ventilation resp. amplitude)
15 HFO delta P Measurement 0 Yes
although Δp is available (if preferred)
16 C20/C C20/C (Overdistension Index) Measurement -1 Yes
DCO_2 (High Frequency Gas Transport Coefficient
17 DCO2 Measurement -1 Yes
value)
18 Mean P MnAwP or Pmean? (Mean airway Pressure) Measurement 0 Yes
19 Compl. Cdyn (Dynamic Lung Compliance) Measurement -1 Yes
20 Resist. Rdyn (Dynamic Lung Resistance) Measurement -1 Yes
21 Leak Leak (leakage in percent) Measurement 255 Yes
22 Leak (Alarm Limits) High Alarm Limit 100 No
23 etCO2 ETCO_2 (End-tidal CO2) Measurement -1 Yes
24 etCO2 (Alarm limits) High and Low Alarm Limit -1 No
25 SpO2 SpO_2 (Percent Oxyhemoglobin Saturation) Measurement 0 Yes
26 SpO2 (Alarm Limits) High and Low Alarm Limit 100 No
27 fgFlow fgFlow (Total Fresh gas flow) Measurement 0 Yes
28 Pulse PULSE (Pulse Rate) Measurement -1 Yes
29 Pulse (Alarm Limits) High and Low Alarm Limit -1 No

30 Trig (eg in CPAP) SpAWRR (Spontaneous Airway Respiration Rate) Measurement -1 Yes

31 Vent Mode sMode (Enumeration Setting: Mode) Setting Standby No


32 High PIP/PAW highP (Alarm Limit: High Pressure) Alarm Limit 0 No
sAWRR ( Set Airway Respiratory Rate measured in
33 Set RR Setting 0 No
rpm)

34 Set Ti sInsTi (set Inspiratory Time in seconds) Setting 0 No

sHFVRR (Set High frequency ventilation respiration


35 Set HFO Freq Setting 0 Yes
rate in Hz)

185
Technical data

Default
Parameter Available
SLE 6000 Label Philips Monitor Label Param Type value to
Nº on Vuelink
display
36 Set PEEP/CPAP sPEEP (set PEEP in mbar) Setting 0 No
37 Set Vte sTV (set tidal volume in ml) Setting 0 No
38 Set PIP sPIP (set PIP in mbar) Setting 0 No

39 Set O2 sO2 (Setting: Oxygen Concentration in %) Setting 0 No

40 Set HFO delta P sHFVAm (set high frequency ventilaton amp) Setting 0 No

sHFMAP (Setting: Mean Airway Pressure, around


41 Set HFO Mean Setting 0 No
which High Frequency Oscillations occur)

42 Breath Trig Threshold sTrgFl (set Flow Trigger) Setting 0 Yes


43 Apnoea alarm time sAADel (Apnoea Alarm Delay) Setting 0 No

44 Set flow sfgFl (Setting: total fresh gas flow on the mixer) Setting 0 No

sRRbak (Setting: Backup Respiration Rate of


45 Backup RR Setting 0 No
ventilator)

Trigger sensitivity (not


47 sTrig (Setting: Trigger Sensitivity) Setting 0 No
flow)
48 sSpO2 sSpO2 (Midpoint of target range) Setting 0 No
49 Perf Perfusion Measurement 0 No

27.4.4 Alarm messages


Affected
Philips Message Type Philips alarm message 6000 Alarm (ID)
Parameters
1 “VENT NOPERATIVE” Alarm system failure (40,73) All
General Hard Inop (data not available) Power supply error (114, 118)
Power supply fault (115)
Ventilator out of calibration (106)
Monitor hardware fault. (117)
Controller hardware error (72)
Controller system error (71)
Monitor hardware fault (27)
Monitor isolated communication (25)
Monitor isolated system error (26)
Unable to calibrate flow ADC (27)
User interface has reset (68)
Internal communication fault (100)
Check data output (75)
Nurse call error (41)
2 “O2 SENSOR” O2 Cell Disconnected (15) FIO_2
Specific Hard Inop (data not available) O2 Cell Exhausted (3)
O2 Cell Cal Fail (4)
O2 Cell Calibration
3 “FLOW SENSOR” Flow sensor defect (31) TVex
Specific Hard Inop (data not available) Flow sensor contaminated (32) TVin
Connect flow sensor (30) MV
Cannot Calibrate flow sensor (29) Cdyn
Calibrate flow sensor (28) Rdyn
Flow sensor reverse (83) Leak
Flow sensor clipped (82) C20/C
DCO_2
4 “SPO2 SENSOR” All 14 SPO2 system alarms from excluding PULSE
Specific Hard Inop (data invalid useless) External sensor communication error (151) SpO_2

186
Technical data

Affected
Philips Message Type Philips alarm message 6000 Alarm (ID)
Parameters
5 “ETCO2 SENSOR” All 11 ETCO2 system alarms from excluding ETCO_2
Specific Hard Inop (data invalid useless) External sensor communication error (151) PCO_2
PO_2

6 “PR. SENS. DRIFT” Pres. Sens. Drift (15) PEEP/CPAP


Specific Soft Inop (data invalid useless) PIP
HFVAm
MnAwP
Cdyn
Rdyn
7 “LOW PRESSURE” Sust. sub ambient (81)
Red Alarm Sub ambient (80)
Low PIP (24)
Low pressure (17)
Mean pressure low (91)
8 “HIGH PRESSURE” Cont. positive press (20)
Red Alarm High Pressure (16)
High Paw(99)
High PIP (23)
High CPAP (21)
PEEP too high(22)
Mean pressure high(91)
9 “VENT FAILURE” Monitor communication error (UI generated
Red Alarm alarm)
Controller hardware error (72)
Ventilator out of calibration (106)
Monitor isolated communication error (23)
Monitor isolated system error (26)
User interface has reset (68)
Alarm system failure (40)
OxyGenie is not available (210)
Auto O2 unexpected reset (211)
SpO2/etCO2 Hardware fault (151)
10 “CYCLE FAIL” Fail to cycle (19)
Red Alarm
11 “PR. SENS. DRIFT” Pressure sensor fault (15) PEEP
Red Alarm PIP
HFVAmp
MnAwP
Cdyn
Rdyn
12 “HFO P CHANGE” Pressure MAX change (96)
Red Alarm Delta Pressure Rise (97)
Delta pressure drop (98)
13 “GAS SUPPLY FAIL” No Gas (64)
Red Alarm No O2 Supply (62)
No Air Supply (63)
14 “BATTERY” Battery fault (47)
Red Alarm Battery Low (45,48)
15 “PAT. CIRCUIT” Blocked Fresh Gas (60)
Red Alarm Leaking Fresh Gas (61)
16 “APNOEA” Apnoea Breath (55)
Red Alarm Apnoea - Volume (54)
Apnoea - Pressure (18)
17 “HIGH RR” High BPM(120)
Red Alarm
18 “AUTO O2” Fast increase in O2 (209)
Yellow Alarm O2>X% (208)

187
Technical data

Affected
Philips Message Type Philips alarm message 6000 Alarm (ID)
Parameters
19 “SPO2” All 18 SPO2 system and patient alarms
Yellow Alarm
20 “ETCO2” All 17 ETCO2 system and patient alarms
Yellow Alarm

21 “FLOW SENS ALARM” Flow sensor defect (31) TVex


Yellow Alarm Flow sensor contaminated (32) TVin
Connect flow sensor (30) MV
Cannot calibrate flow (29) Cdyn
Calibrate flow sensor (28) Rdyn
Flow sensor reverse (83) Leak
Flow sensor clipped (82) C20/C
DCO_2
22 “VOLUME ALARM” High Minute Vol (50)
Yellow Alarm Pat. Leak Alarm (53)
Low Tidal Vol. (52)
High Tidal Vol. (56)
Low Minute Vol (51)
23 “POWER FAIL” Main Power Fail (46)
Yellow Alarm
24 “O2 CELL FAIL” O2 Cell Disconn (1) FIO_2
Yellow Alarm O2 Cell needs cal(2)
O2 Cell needs repl (3)
O2 Cell Cal Fail (4)
25 “O2 ” High O2 Level (5)
Yellow Alarm Low O2 Level (6)

27.4.5 Waveform

AWP (airway pressure)


AWF (airway flow)
AWV (airway volume)
CO_2 (Carbon dioxide wave - airway)
PLETH
(PLETH wave delivered by the SpO_2 parameter)

27.4.6 VueLink Task Window Layout

The VueLink task window for the SLE6000


will display the parameters as shown
below.
|-------------------|-------------------|-------------------|
| AWRR rpm | TVex ml | sHFVRR Hz |
| | | |
| PIP mbar | MV l | MnAwP mbar |
| | | |
| PEEP mbar | Leak % | HFVAmp mbar |
| | | |
| InsTi sec | Cdyn ml/mbar | DCO_2 |
| | | |
| ExpTi sec | Rdyn mbar/l/s | fgFlow l/min |
| | |-------------------|
| SpAWRR rpm | TVin ml | ETCO_2 mmHg |
| | |-------------------|
| | C20/C | SpO_2 % |
| |-------------------| |
| FIO_2 % | sTrgFl l/min | PULSE bpm |
|-------------------|-------------------|-------------------|

188
Technical data

27.5 Nurse call 27.9 External Monitor


The external monitor output allows the ventilator to
Warning. Use of the nurse call function does
connect any medical grade monitor that can display
not remove the need to monitor both the
patient or ventilator at regular intervals. XGA outputs at a resolution of 1024 x 768 pixels.

When connected to a hospital nurse call system the Note: The external monitor must be
ventilator will generate an activation signal on the connected to the VGA output port or
following alarm conditions: DisplayPort output port (depending on model)
prior to the ventilator being switched on. The
Condition 1. Any high priority alarm (Patient & ventilator only checks for external monitors
Technical) on power up.
Condition 2. A monitor system failure
Warning. An external monitor should not be
Condition 3. A total power failure or shutdown of the connected to the ventilator when being used
ventilator. clinically. The external monitor should only be
used for demonstrations or training
When the high priority alarm is cleared the
purposes.
activation signal for the nurse call system is
cancelled.

Pressing the ventilators ON/OFF button shall


deactivate the nurse-call activation signal for
conditions 2 and 3.

Note: For alarm condition 3 the duration of


the alarm activation signal is approximately 2
to 9 minutes.

27.5.1 Nurse call delay


The delay in activation of the nurse call alarm is
5ms.

27.6 Ethernet
The ethernet port is non-functional in this release of
software.

27.7 USB (Data)


The ventilator is supplied with one bi-directional
USB 2.0 data port. The port is utilised in the export
of patient log, event log, and screen captures, plus
in the upgrade of ventilator software.

27.8 USB (Power)


The ventilator is supplied with one USB 2.0 power
port. The port is utilised to power USB powered
ultrasonic nebuliser. The port is active when the
ventilator is turned on.

189
Technical data

28. Input ports (Electrical) 29. Sensor Specifications


Note: Additional information on sensor
28.1 SpO2 and etCO2 accuracy can be found with the instructions
Both SpO2 and etCO2 devices are type BF applied for use supplied with the sensor.
parts.
29.1 Masimo SET®
28.2 Flow sensor Patent information . . www.masimo.com/
The flow sensor is a type BF applied part. patents.htm

28.3 DC 24V 29.1.1 Functional SpO2 (%)


This port is to allow an external 24V 4A direct power Specification Criteria
supply to be connected. Display Range . . . . . 0.0% -100.0%
Calibration Range . . 70%-100%
Caution: Use only a medical grade 24V DC Calibration Standard. Invasive Co-oximeter
power supply with a current rating of 4A.
No motion Accuracy - Infant and Paediatric sensors
(rms) .......................... ≤2.0%
No motion Accuracy - Neonatal sensors
(rms) . . . . . . . . . . . . . ≤3.0%
Motion Accuracy
(rms) . . . . . . . . . . . . . ≤3.0%
Resolution . . . . . . . . ≤0.1 %
Time to Display. . . . . ≤8 seconds
Asystole Detection
Time . . . . . . . . . . . . . ≤8 seconds
Delay . . . . . . . . . . . . ≤10 seconds
Response Time . . . . ≤20 seconds
Display Update
Frequency . . . . . . . . ≥ 1 Hz
Average Time
(seconds) . . . . . . . . . 2-4, 4-6, 8, I 0, 12, 14, 16

29.1.2 Pulse rate (BPM)


Specification Criteria
Display Range . . . . . 25 BPM - 239 BPM
Calibration Range . . 25 BPM - 239 BPM
Calibration Standard. ECG and Patient Simulator
No motion Accuracy
(rms) . . . . . . . . . . . . . ≤ 3.0 BPM
Motion Accuracy
(rms) . . . . . . . . . . . . . ≤ 5.0 BPM
Resolution . . . . . . . . ≤ 1 BPM
Time to Display. . . . . ≤8 seconds
Asystole Detection
Time . . . . . . . . . . . . . ≤8 seconds
Delay . . . . . . . . . . . . ≤10 seconds
Response Time . . . . ≤20 seconds
Display Update
Frequency . . . . . . . . ≥ 1 Hz

190
Technical data

29.1.3 Perfusion index (%) performing rubbing and tapping motions, at 2 to 4


Specification Criteria Hz at an amplitude of 1 to 2 cm and a non-repetitive
Display Range . . . . . 0.02% - 20.0% motion between 1 to 5 Hz at an amplitude of 2 to 3
cm in induced hypoxia studies in the range of 70-
Calibration Range . . 0.10% - 20.0%
100% SpO2 against a laboratory CO-Oximeter and
Calibration Standard . Patient Simulator
ECG monitor. This variation equals ±1 standard
Resolution . . . . . . . . . ≤ 0.01% deviation. Plus or minus one standard deviation
Time to Display . . . . . encompasses 68% of the population. 1% has been
Asystole Detection added to the results to account for the effects of
Time . . . . . . . . . . . . . ≤8 seconds fetal hemoglobin present in neonates.
Delay . . . . . . . . . . . . . ≤10 seconds 5. The Masimo SET technology with Masimo
Response Time . . . . ≤20 seconds sensors has been validated for pulse rate accuracy
Display Update for the range of 25 - 239 BPM in bench top testing
Frequency . . . . . . . . . ≥ 1 Hz against a Biotek Index 2™ simulator. This variation
equals ±1 standard deviation. Plus or minus one
29.1.3.1 Senor Wavelength range standard deviation encompasses 68% of the
Masimo sensor Wavelength range = 653-905nm population.
Masimo sensor Output power ≤ 15mW
6. See sensor directions for use (DFU) for complete
29.1.4 Accuracy notes application information. Unless otherwise indicated,
reposition reusable sensors at least every 4 hours
1. The Masimo SET technology with Masimo
and adhesive sensors at least every 8 hours.
sensors has been validated for no motion accuracy
in human blood studies on healthy adult male and 7. Sensor accuracy specified when used with
female volunteers with light to dark skin Masimo technology using a Masimo patient cable
pigmentation in induced hypoxia studies in the for LNOP sensors, RD SET sensors, the LNCS
range of 70-100% SpO2 against a laboratory CO- sensors, or the M-LNCS sensors. Numbers
Oximeter and ECG monitor. This variation equals represent Arms (RMS error compared to the
±1standard deviation. Plus or minus one standard reference). Because pulse oximeter measurements
deviation encompasses 68% of the population. are statistically distributed, only about two-thirds of
the measurements can be expected to fall within a
2. The Masimo SET technology with Masimo
range of ± Arms compared to the reference value.
sensors has been validated for motion accuracy in
Unless otherwise noted, SpO2 accuracy is specified
human blood studies on healthy adult male and
from 70% to 100%. Pulse Rate accuracy is specified
female volunteers with light to dark skin
from 25 to 240 bpm.
pigmentation in induced hypoxia studies while
performing rubbing and tapping motions, at 2 to 4 8.Masimo M-LNCS, LNOP, RD SET, and LNCS
Hz at an amplitude of 1 to 2 cm and a non-repetitive sensors types have the same optical and electrical
motion between 1 to 5 Hz at an amplitude of 2 to 3 properties and may differ only in application type
cm in induced hypoxia studies in the range of 70- (adhesive/non-adhesive/hook & loop), cable
100% SpO2 against a laboratory CO-Oximeter and lengths, optical component locations (top or bottom
ECG monitor. This variation equals ±1 standard of sensor as aligned with cable), adhesive material
deviation, which encompasses 68% of the type/size, and connector type (LNOP 8 pin modular
population. plug, RD 15 pin modular plug, LNCS 9 pin, cable
based, and M-LNCS 15 pin, cable based). All
3. The Masimo SET technology has been validated
sensor accuracy information and sensor application
for low perfusion accuracy in bench top testing
instructions are provided with the associated sensor
against a Biotek Index 2™ simulator and Masimo’s
directions for use.
simulator with signal strengths of greater than
0.02% and transmission of greater than 5% for
saturations ranging from 70 to 100%. This variation
equals ±1 standard deviation. Plus or minus one
standard deviation encompasses 68% of the
population.

4. The Masimo SET Technology with Masimo Neo


sensors has been validated for neonatal motion
accuracy in human blood studies on healthy adult
male and female volunteers with light to dark skin
pigmentation in induced hypoxia studies while

191
Technical data

29.1.5 Environmental 29.2 MicroPod™


29.1.5.1 Operating Conditions Patent information . . US Patents:
Incandescent Light www.covidien.com/patents
Intensity. . . . . . . . . . . 100 k Lux (Sunlight) CO2 Units . . . . . . . . mmHg or kPa or Vol%
Fluorescent Light CO2, etCO2 Range . 0-150 mmHg
Intensity. . . . . . . . . . . 10 k Lux CO2 Waveform
Fluorescent Light Resolution . . . . . . . . 0.1 mmHg
Frequency . . . . . . . . . 50, 60 Hz ± l.0 Hz EtCO2 Resolution . . 1 mmHg
Temperatures @
CO2 Accuracy* . . . . 0-38 mmHg: ± 2 mmHg
ambient humidity . . . . 5ºC to 40ºC
39-150 mmHg: ± (5% of
Humidity . . . . . . . . . . 15% to 95%, non-condensing expected reading in mmHg +[
Pressure . . . . . . . . . . 500 to 1060 mbar 0.08 x (expected reading in
29.1.5.2 Storage Conditions mmHg –39mmHg)])**
Temperature@ Accuracy in the
ambient humidity . . . . -40ºC to 70ºC presence of interfering
Humidity . . . . . . . . . . 15% to 95%, non-condensing gases . . . . . . . . . . . . The accuracy specification is
as described below in the
29.1.5.3 Implied license statement presence of interfering
Possession or purchase of this device does not gases.
convey any express or implied license to use the
device with un-authorised sensors or cables which 0-38 mmHg: ± (2 mmHg +
would, alone or in combination with this device, fall 4% of the expected reading
within the scope of one or more of the patents in mmHg)
relating to this device.
39-150 mmHg: ± (9% of
expected reading in mmHg +[
0.08 x (expected reading in
mmHg –39mmHg)])
Respiration Rate
Range . . . . . . . . . . . 0-150 bpm
Respiration Rate
Accuracy . . . . . . . . . The accuracy test is
described in the SLE6000
service manual.
0-70 bpm: ±1 bpm
71-120 bpm: ±2 bpm
121-150 bpm: ±3 bpm
Drift of measurement
accuracy . . . . . . . . . . Regarding drift, please note
that the periodic auto zero
function compensates for
drifts between components,
changes in ambient
temperature, and barometric
conditions. This automatic
process eliminates variances
that might otherwise cause
measurement drift. Therefore
the module does not exhibit
drift.

Flow Rate . . . . . . . . 50 (tolerance -7.5, +15) ml/


min, flow measured by
volume

192
Technical data

Waveform Rise Time 29.2.3 Calculation methods for Capnography


10% to 90%. . . . . . . . . 1.72 seconds Capnography is a non-invasive method for
Waveform Sampling . 20 samples/s monitoring the level of carbon dioxide in exhaled
Initialization Time . . . 40 s (typical, includes power- breath (EtCO2) to assess a patient’s ventilatory
up and initialization time) status.
* In cases where the requirements of ISO 80601-2- Microstream™ capnography modules uses
55 are more stringent than the accuracy indicated Microstream™ non–dispersive infrared (NDIR)
by the table above, the MicroMediCO2 complies spectroscopy to continuously measure the amount
with the more stringent requirements. of CO2 during every breath, the amount of CO2
present at the end of exhalation (EtCO2), the
**For breath rates above 80 bpm, accuracy is 4
amount of CO2 present during inhalation (FiCO2),
mmHg or ±12 % of reading (whichever is greater)
and the Respiratory Rate.
for etCO2 values exceeding 18 mmHg.
Infrared spectroscopy is used to measure the
Peak picking . . . . . . . The module selects the peak concentration of molecules that absorb infrared
etCO2 value in a twenty light. Because the absorption is proportional to the
second window and this is concentration of the absorbing molecule, the
displayed in the monitored concentration can be determined by comparing its
values panel. absorption to that of a known standard.
Calibration Interval . . Initially calibrate after 1,200
operating hours, then once a 29.2.4 Environmental
year or after 4,000 operating
29.2.4.1 Operating Conditions
hours, whichever comes first.
Operating Temperature 0°C to 40°C
The initial calibration should
not occur before 720 hours of Operating Pressure . 57kPa to 106kPa (430 mmHg
use. If the initial calibration is to 795 mmHg)
done before 720 hours of Operating Altitude . . -381m to 15,240m (-1250
use, the module will reset to feet to 50,000 feet)
require its next calibration Altitude change rate 500ft/min (152m/min)
after 1200 hours, instead of maximum or ambient
after 4000 hours. pressure change of 2.4
Servicing . . . . . . . . . . After 30,000 operating hours, mmHg/min maximum.
certain components of the Operating Humidity . 10% to 95% non-condensing
capnography module need
Note: When using module with a ventilator,
servicing.
under high over pressures close to 10kPa
System Response Time (100cmH2O), the module may enter into a
etCO2 . . . . . . . . . . . . 6.83 seconds blockage mode in order to protect the module
Compensation . . . . . BTPS (standard correction from damage.
used by MicroPod™
capnography during all 29.2.4.2 Storage Conditions
measurement procedures for Storage & Transport
body temperature, pressure, Temperature . . . . . . -40°C to 70°C.
and saturation) Storage & Transport
Humidity . . . . . . . . . 10% to 95% non-condensing
29.2.1 Alarm limits
Storage & Transport
Low etCO2 . . . . . . . . . 0-145 mmHg
Pressure . . . . . . . . . 57kPa to 106kPa (430 mmHg
High etCO2 . . . . . . . . 5-150 mmHg to 795 mmHg)
Storage & Transport
29.2.2 Measurement formats
Altitude . . . . . . . . . . -1250 feet to 50,000 feet (-
The MicroPod™ provides CO2 data in the following
381m to 15,240m)
units:
29.2.4.3 Trademarks
mmHg. Microstream™, MicroPod™ , FilterLine™ are
% volume trademarks of a Medtronic company.

kPa

193
Technical data

30. Alarms 30.1.3 Alarm log


The SLE6000 incorporates an intelligent alarm The ventilator stores the last 1000 alarm messages
system that priorities the alarm messages, deals in the alarm log. When a new alarm is generated the
with muting of some of the alarms and enables 5 oldest alarm message is discarded.
levels of sound adjustments from 20% to 100%.
The alarm log is retained after powering down the
30.1 Alarm Prioritization unit or after a total loss of power.

The alarm signals generated by the alarm system 30.2 Alarm Indicators characteristics
are priority encoded, where the high priority alarm
Each alarm priority signal is accompanied by an
signal conveys a higher level of urgency than the
visual alarm, where red colour is used to indicate
medium or low priority alarm signals.
high priority alarm, amber colour is used to indicate
The medium priority alarm signal conveys a higher medium priority alarm and cyan colour is used to
level of urgency than the low priority alarm signal. indicate low priority. The high, medium and low
priority alarms have the characteristics detailed
Upon generation of an alarm a message indicating below.
the type of alarm is displayed to the user.
Alarm Indicator Flashing Duty
Simultaneously an audible alarm of the correct Category Colour Frequency Cycle
priority level is sounded. When changing modes, for High priority Red 1.9 Hz 30% on
any alarm that have been triggered the alarm
Medium
volume level is set to its minimum setting, for a Yellow 0.5 Hz 30% on
priority
period of 10 seconds. After the 10 seconds has
expired the alarm loudness will returns to the user Constant
Low priority Cyan 100% on
set value. (On)

The operator can inactivate nuisance generation of


auditory alarms for maximum period of 2
minutes.The operator can adjust the loudness of the
alarm.

Note: In the event of a mains power fail


situation there is no change in operation of
the alarm system or settings.

30.1.1 Alarm Characteristics


The ventilator produces three types of alarm
signals: high, medium and low priority depending on
the alarm condition.

The High priority alarm signal consists of 10 pulses.


A sequence of 5 pulses repeated once followed by a
10 second gap before restarting.

The Medium priority alarm signal consists of 3


pulses followed by a 20 second gap.

The Low priority alarm signal consists of 2 pulses,


alarm is not repeated.

30.1.2 Alarm sounder volume


For maximum volume setting.

High priority alarm: 70 dBA

Medium priority alarm: 70 dBA

Low priority alarm: 70 dBA

194
Technical data

A High Pressure Threshold Exceeded. .............. 203


A new oxygen cell is required. ....................... 215 High Pulse Rate ............................................. 226
Alarm system failure ....................................... 197, High Respiratory Rate. ................................... 214
217, High SpO2 ...................................................... 226
218 High Tidal volume ........................................... 213
Apnoea ........................................................... 213,
214 I
Internal communication fault .......................... 216
B Invalid CO2 Value .......................................... 229
Battery fault .................................................... 207
Battery low. .................................................... 208 L
Blocked Fresh Gas. Check patient circuit. ..... 208 Leaking Fresh Gas. Check patient circuit. ...... 208
Breath Not Detected. ...................................... 213 Low CO2 ........................................................ 231
Low etCO2 ..................................................... 230
C Low Oxygen Level. ......................................... 216
Calibrate Flow Sensor. ................................... 211 Low Perfusion Index (SpO2) .......................... 232
Check data output .......................................... 217 Low PIP .......................................................... 204
CO2 value over-range .................................... 229 Low Pressure ................................................. 204
Continuing Positive Pressure ......................... 202 Low Pulse Rate .............................................. 226
Controller hardware error ............................... 201 Low SpO2 ....................................................... 226
Controller system error ................................... 202 Low SpO2 Signal IQ ....................................... 232
Cycle Fail. ...................................................... 205 Low Tidal volume ........................................... 212

D M
Defective SpO2 Sensor - 1 ............................ 225 Main Power Fail. ............................................. 214
Defective SpO2 Sensor - 2 ............................ 225 Minute volume below low threshold. .............. 213
Monitor communication error .......................... 197
Monitor hardware fault .................................... 201,
E
207
etcCO2 Self Maintenance Mode .................... 233
Monitor isolated communication error ............ 209
etCO2 Calibration Is Due ............................... 233
Monitor isolated system error ......................... 209
etCO2 initializing ............................................ 233
etCO2 Maintenance Is Due ............................ 234
etCO2 Module Fault - 1 .................................. 227 N
etCO2 Module Fault - 2 .................................. 227 No Adhesive SpO2 Sensor Connected .......... 224
etCO2 Module Fault - 3 .................................. 228 No Air Supply ................................................. 207
etCO2 Module Fault - 4 .................................. 228, No etCO2 Breath ............................................ 230
229 No etCO2 FilterLine connected ...................... 228
etCO2 Pump Off ............................................. 233 No etCO2 Module Connected ........................ 227
etCO2 Purge .................................................. 233 No Gas ........................................................... 202
No O2 Supply ................................................. 206
No SpO2 Module Connected ......................... 223
F
No SpO2 Sensor Connected .......................... 224
Flow Sensor Clipping ..................................... 211
Flow sensor is contaminated. ......................... 210
Flow sensor is defective. ................................ 210 O
Flow sensor is not connected. ........................ 210 O2 Calibration Fail .......................................... 215
Flow Sensor Reversed ................................... 211 O2 over set limit ............................................. 216
O2 sensor disconnected ................................. 214
OxyGenie is not available ............................... 216
H
OxyGenie Unexpected reset .......................... 217
High CO2 ....................................................... 230
High etCO2 .................................................... 230
High etCO2 Spont .......................................... 231 P
High Minute Volume ....................................... 212 Power supply error ......................................... 198
High Oxygen Level. ........................................ 215 Power supply error. Restart ventilator. ........... 199
High Patient Leak. .......................................... 212 Power supply fault .......................................... 199
High Paw ........................................................ 203 Power supply faulty ........................................ 221
High PEEP ..................................................... 205 Pressure change detected. ............................ 204
High PIP ......................................................... 203 Pressure sensor fault ..................................... 205

195
Technical data

Pulse Not Detected (SpO2) ........................... 225


Pulse Search .................................................. 232

R
Replace etCO2 FilterLine ............................... 228

S
SpO2 Hardware Fault - 1 ............................... 223
SpO2 Hardware Fault - 2 ............................... 223
SpO2 Hardware Fault - 3 ............................... 224
SpO2 Sensor Interference Detected .............. 225
SpO2 Sensor Off Patient ............................... 225
SpO2/etCO2 Hardware Fault ......................... 223,
227
Sub Ambient Pressure - 1 .............................. 200
Sub Ambient Pressure - 2 .............................. 200

T
The oxygen cell needs calibrating. ................. 215
Too Much Ambient Light (SpO2) ................... 232
Total power fail ............................................... 218

U
UI internal communication error ..................... 198
Unable to calibrate flow sensor. ..................... 211
Unexpected Drop in Delta Pressure .............. 206
Unexpected Drop in Mean Pressure .............. 206
Unexpected Rise in Delta Pressure ............... 206
Unexpected Rise in Mean Pressure .............. 205
User interface has reset ................................. 212

V
Ventilator out of calibration ............................ 200

196
Technical data

30.3 Alarm table


Alarm message: Alarm system failure. Remove ventilator from use.
Alarm condition: Alarm generator error Alarm type: Technical
Active in all modes Alarm ranking: 0
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the monitor sub system fails to communicate with the alarm
controller. The monitor sub system will attempt to communicate 5 times before initiating the alarm.
The alarm history will display “0”
Ventilator action: The ventilator will display this alarm message and sound the backup sounder. The user
cannot cancel the backup sounder alarm tone. If a new alarm is generated the visual component of the alarm
is cancelled only. On this action the alarm priority changes to 68.
User action: Transfer the patient to an alternative form of ventilation. Remove ventilator from
service. Route ventilator for repair.

Alarm message: Monitor communication error. Restart ventilator.


Alarm condition: Monitor failure Alarm type: Technical
Active in all modes Alarm ranking: 0
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the user interface can no longer communicate to the monitor
subsystem.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “Monitor communication error. Restart ventilator.” re-
appears transfer the patient to an alternative form of ventilation. Withdraw ventilator from use. Route
ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. If required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

197
Technical data

Alarm message: UI internal communication error. Restart ventilator.


Alarm condition: User interface error (comms) Alarm type: Technical
Active in all modes Alarm ranking: 0
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the user interface can no longer communicate to the monitor or
controller subsystems.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “UI internal communication error. Restart ventilator.”
re-appears transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. If required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

Alarm message: Power supply error.


Alarm condition: Power supply communication error Alarm type: Technical
Active in all modes Alarm ranking: 1
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated whenever the monitor sub system fails to communicate with the power
supply.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Press Reset
Note: The user can press reset up a maximum of 5 times. After the fifth reset press a new alarm is
generated “Power supply fault. Restart ventilator.”. See “Alarm message: Power supply error.
Restart ventilator.” on page 199.

198
Technical data

Alarm message: Power supply error. Restart ventilator.


Alarm condition: Power supply communication error 1 Alarm type: Technical
Active in all modes Alarm ranking: 2
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the “Power supply error” alarm is acknowledged at least 5
times
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “Power supply error Restart ventilator.” re-appears
transfer the patient to an alternative form of ventilation. Withdraw ventilator from use. Route
ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. If required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

Alarm message: Power supply fault. Remove ventilator from use.


Alarm condition: Power supply faulty Alarm type: Technical
Active in all modes Alarm ranking: 3
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated whenever the power supply indicates it is in a fault state. See ““Power
supply fault” fault table” on page 219.
A fault code has been returned by the PSU
Incorrect PSU type.
One or both batteries are faulty.
The batteries are imbalanced.
One or both batteries are under 14.6V.
One or both batteries are not of the correct type.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

199
Technical data

Alarm message: Sub Ambient Pressure - 2


Alarm condition: Sub ambient Phase 2 Alarm type: Patient
Active in all modes Alarm ranking: 4
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: When the proximal pressure falls below -2mbar for greater than 50ms a “Sub ambient Pressure”
alarm is generated.
Ventilator action: Ventilator action: When the monitor subsystem detects the proximal pressure falls below -
2mbar for greater than 50ms it instructs the controller sub-system to shut off all gasses. If the gas are not cut
off during the next 50ms the monitor subsystem intervenes and cuts off the gasses.
User action: Check Patient. Check Patient circuit. If alarm persists transfer the patient to an
alternative form of ventilation. Withdraw ventilator from use. Route ventilator for repair.

Alarm message: Sub Ambient Pressure - 1


Alarm condition: Sub ambient Phase 1 Alarm type: Patient
Active in all modes Alarm ranking: 5
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: When the proximal pressure falls below -2mbar for less than 50ms a “Sub ambient Pressure”
alarm is generated.
Ventilator action: When the monitor subsystem detects the proximal pressure falls below -2mbar for less
than 50ms it instructs the controller sub-system to shut off all gasses. If the gas are not cut off during the next
50ms the monitor subsystem
intervenes and cuts off the gasses.
User action: Check Patient. Check Patient circuit. If alarm persists transfer the patient to an
alternative form of ventilation. Withdraw ventilator from use. Route ventilator for repair.

Alarm message: Ventilator out of calibration. Remove ventilator from use.


Alarm condition: Monitor memory Fault Alarm type: Technical
Active in all modes Alarm ranking: 6
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: Stored calibration values have been corrupted. This check only done on start-up. The values can
only be cleared by turning the ventilator OFF.
The nature of the alarms can be read in from the alarm history tab (Limit field).
See ““Ventilator out of calibration” fault table” on page 220.
Flow calibration values have been corrupted
Oxygen calibration values have been corrupted
Pressure offset calibration values have been corrupted
Pressure gain calibration values have been corrupted
Pressure time constant calibration values have been corrupted
Unable to send calibration data to the isolated side
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

200
Technical data

Alarm message: Monitor hardware fault. Remove ventilator from use.


Alarm condition: ADC VREF specification Alarm type: Technical
Active in all modes Alarm ranking: 7
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: ADC 2V5 REF is out of spec by at least 20%
Other ADC errors are also returned in the alarm history tab (Limit field).
The values can only be cleared by turning the ventilator OFF.
See ““Monitor hardware fault” fault table” on page 221.
2V5 REF (This message will trigger this alarm)
8V Standby error (This message will not trigger this alarm)
5V Sounder error (This message will not trigger this alarm)
3V3 error (This message will not trigger this alarm)
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

Alarm message: Controller hardware error. Restart ventilator.


Alarm condition: Control hardware fault Alarm type: Technical
Active in all modes Alarm ranking: 8
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: A number of controller faults are grouped together under this alarm. The nature of the alarms can
be read in from the alarm history tab (Limit field). See ““Controller hardware fault” fault table” on page 221.
Fresh gas module self-test has failed
Blender module self-test has failed
Breath jet module self-test has failed
Controller not responding
Controller has reset.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “Controller hardware error. Restart ventilator.” re-
appears transfer the patient to an alternative form of ventilation. Withdraw ventilator from use. Route
ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. If required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

201
Technical data

Alarm message: Controller system error. Restart ventilator.


Alarm condition: Control UI not responding Alarm type: Technical
Active in all modes Alarm ranking: 9
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: The controller subsystem sends life-ticks at regular intervals to the UI. If they are interrupted for
more than a prescribed time it is assumed that the controller sub-system is not functioning properly and the
“Controller system error. Restart ventilator.” alarm is generated. Any system error message received from
the controller will also activate this alarm.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “Controller system error. Restart ventilator” re-appears
transfer the patient to an alternative form of ventilation. Withdraw ventilator from use. Route
ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. If required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

Alarm message: No Gas


Alarm condition: Gas not connected Alarm type: Technical
Active in all modes Alarm ranking: 10
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated by the controller subsystem indicating that both air and oxygen supplies
have dropped below 2 bar.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Continuing Positive Pressure


Alarm condition: Continuing Pressure Alarm type: Patient
Active in all modes except O2 therapy Alarm ranking: 11
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the pressure remains more than 5mBar above the user set CPAP level for 4 seconds this alarm
is generated. In pure HFO mode this alarm is generated when the measured mean is more than 15mbar
above the captured mean or 15mbar above the received alarm threshold.
Ventilator action: In conventional modes, if the pressure rises more than 5mbar above the user set pressure
or the continuing positive pressure condition is recognised then the monitor will raise an alarm and instruct
the controller to stop ventilation. If this fails the monitor subsystem intervenes and stops ventilation.
User action: Check Patient. Check Patient circuit. If alarm persists transfer the patient to an
alternative form of ventilation. Withdraw ventilator from use. Route ventilator for repair.

202
Technical data

Alarm message: High Pressure Threshold Exceeded.


Alarm condition: High pressure Alarm type: Patient
Active in all modes except O2 therapy Alarm ranking: 12
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: In conventional modes, if the maximum pressure rises more than 5mbar above the high PIP
pressure threshold the monitor will raise an alarm and instruct the controller to stop ventilation. If this fails the
monitor subsystem intervenes and stops ventilation.
Ventilator action: If the pressure is 5mbar above the High PIP threshold a command is sent to the controller
to cut the gas but maintain the CPAP/PEEP/Mean.
If the pressure goes 20 mbar above the High PIP threshold the monitor should cut the all the gas off.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High PIP
threshold.

Alarm message: High Paw


Alarm condition: High Paw Alarm type: Patient
Active in HFO, HFO+CMV & NHFOV only. Alarm ranking: 13
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone above the High Paw alarm threshold by no more than 5 mbar.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High Paw
threshold.

Alarm message: High PIP


Alarm condition: High PIP Alarm type: Patient
Active in all modes except HFO, NHFOV and O2 therapy. Alarm ranking: 14
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone above the High PIP alarm threshold by no more than 5 mbar.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High PIP
threshold.

Alarm message: High CPAP


Alarm condition: High CPAP Alarm type: Patient
Active in CPAP mode only Alarm ranking: 15
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone above the High CPAP alarm threshold.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High CPAP
threshold.

203
Technical data

Alarm message: Low PIP


Alarm condition: Low PIP Alarm type: Patient
Active in all modes except HFO, NHFOV and O2 therapy Alarm ranking: 16
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition:
For CPAP. CMV, PSV, PTV & SIMV
1.Proximal pressure has to rise from below to the above of Low PIP alarm threshold during inspiration period
and it has to remain above the threshold for set the inspiration period.
For NIPPV and NIPPVtr
1. The Low PIP alarm is disabled if the difference between the PIP and PEEP are set to 6mbar or less.
2. If the difference between the PIP and PEEP is more than 6 mbar then the following applies
a. If RR is 50 BPM or more the alarm would sound after 5 ventilator cycle.
b. If RR is less than 50 BPM the alarm would sound after 2 ventilator cycle.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or Low PIP
threshold.

Alarm message: Low Pressure


Alarm condition: Low pressure Alarm type: Patient
Active in all modes Alarm ranking: 17
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: If the proximal pressure is below the Low PEEP pressure level this alarm is generated
Ventilator action: If the proximal pressure is below the set Low PEEP pressure level the ventilator will display
this alarm message. If the mean pressure drops below zero then the monitor will instruct the controller to
stop ventilation. If this fails the monitor subsystem intervenes and stops ventilation.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or Low PEEP
threshold.

Alarm message: Pressure change detected.


Alarm condition: Pressure MAX Change Alarm type: Patient
Active in HFO+CMV only Alarm ranking: 18
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Upon a change in the ventilator setting the maximum and minimum pressure during inspiratory
and expiratory phase is captured.
For this alarm to trigger the following conditions must be true:
Condition 1:
1-The captured expiratory maximum pressure must be less than 10mBar
2-The maximum pressure during the inspiration phase differs from the captured value by more than 5mBar.
Condition 2:
2-The maximum pressure during the expiration phase differs from the captured value by more than 5mBar.
Ventilator action: If the conditions for scenario 1 or 2 are met the ventilator will display this alarm message.
User action: User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or
press Auto Set.

204
Technical data

Alarm message: Cycle Fail.


Alarm condition: Fail to cycle Alarm type: Patient
Active in all volume modes. Alarm ranking: 19
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If Targeted volume is active this alarm would be generated if 2 consecutive breaths show a PEEP
and PIP of < 3mbars.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Pressure sensor fault. Remove ventilator from use.


Alarm condition: Pressure drift Alarm type: Patient
Active in all modes except O2 therapy Alarm ranking: 20
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the readings from the two input pressure transducers differ by more than 5 mbar for more than
0.5 seconds this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

Alarm message: High PEEP


Alarm condition: PEEP too high Alarm type: Patient
Active in all modes except HFO, NHFOV and O2 therapy Alarm ranking: 21
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: Proximal pressure has gone above the High PEEP alarm threshold during the expiratory cycle.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Unexpected Rise in Mean Pressure


Alarm condition: Mean Pressure High Alarm type: Patient
Active in HFO and NHFO only Alarm ranking: 22
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the mean proximal pressure is above the set mean pressure by more than 5 mbar this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

205
Technical data

Alarm message: Unexpected Drop in Mean Pressure


Alarm condition: Mean Pressure Low Alarm type: Patient
Active in HFO and NHFO only Alarm ranking: 23
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the mean proximal pressure is below the set mean pressure by more than 5 mbar this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Unexpected Rise in Delta Pressure


Alarm condition: Delta Pressure Rise Alarm type: Patient
Active in HFO and NHFO only Alarm ranking: 24
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the minimum and maximum of the proximal pressure increases/ decreases by more than 5 mbar
compared to the captured value this alarm is raised
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Unexpected Drop in Delta Pressure


Alarm condition: Delta Pressure Drop Alarm type: Patient
Active in HFO and NHFO only Alarm ranking: 25
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the proximal pressure decreases by more than 5 mbar compared to the captured value this
alarm is raised
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message ranked 26 is no longer used in this version of software

Alarm message: No O2 Supply


Alarm condition: O2 not connected Alarm type: Technical
Active in all modes Alarm ranking: 27
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated by the controller subsystem indicating the Oxygen supply has dropped
below 2 bar.
Ventilator action: The ventilator will display this alarm message and continue to operate on the air supply.
User action: Transfer the patient to an alternative form of ventilation.

206
Technical data

Alarm message: No Air Supply.


Alarm condition: Air not connected Alarm type: Technical
Active in all modes Alarm ranking: 28
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated by the controller subsystem indicating the Air supply has dropped below 2
bar.
Ventilator action: The ventilator will display this alarm message and continue to operate on the oxygen
supply.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Monitor hardware fault. Remove ventilator from use.


Alarm condition: ADC Voltage spec Alarm type: Technical
Active in all modes Alarm ranking: 29
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated whenever some of the voltage rails on the monitor board are out of
specification (dropped by more than 20%). The error codes can be read in from the alarm history tab (Limit
field).
See ““Monitor hardware fault” fault table” on page 221.
2V5 REF (This message will not trigger this alarm)
8V Standby error (This message will trigger this alarm)
5V Sounder error (This message will trigger this alarm)
3V3 error (This message will trigger this alarm)
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

Alarm message: Battery fault. Remove ventilator from use.


Alarm condition: Power Supply battery integrity Alarm type: Technical
Active in all modes Alarm ranking: 30
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: If the battery is not connected or faulty this alarm is generated
Ventilator action: The ventilator will display this alarm message. In the event of a mains power fail condition
the ventilator will shut down but will provide a flow of fresh gas to assist with spontaneous breathing (1.8 l/
min).
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

207
Technical data

Alarm message: Battery low.


Alarm condition: Power supply less than 10 minutes left to full
Alarm type: Technical
discharge
Active in all modes Alarm ranking: 31
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated if there is less than 10 minutes to full battery exhaustion.
Ventilator action: The ventilator will display this alarm message and continue to operate.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Battery low.


Alarm condition: Power supply battery low Alarm type: Technical
Active in all modes Alarm ranking: 32
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: This alarm is generated if there is less than 25% capacity.
Ventilator action: The ventilator will display this alarm message and continue to operate.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Blocked Fresh Gas. Check patient circuit.


Alarm condition: Block alarm Alarm type: Patient
Active in all modes Alarm ranking: 33
Alarm type: Visual and audible Alarm priority: High
Latching: No, except in O2 therapy Alarm mutable: No
Definition: This alarm is generated by the controller subsystem indicating that the fresh gas limb of the
patient circuit is blocked.
Ventilator action: The fresh gas pressure is constantly monitored by the controller sub system. This pressure
reading is also continually requested by the monitoring subsystem.
User action: Check Patient circuit.

Alarm message: Leaking Fresh Gas. Check patient circuit.


Alarm condition: Leak alarm Alarm type: Patient
Active in all modes Alarm ranking: 34
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated by the controller subsystem indicating that the fresh gas limb of the
patient circuit is leaking.
Ventilator action: The ventilator will display this alarm message but attainable PEEP and PIP pressures will
be reduced.
User action: Check Patient circuit.

208
Technical data

Alarm message: Monitor isolated communication error. Restart ventilator.


Alarm condition: Serial communication error Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 35
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: The internal communication error has occurred within the monitor subsystem.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “Monitor isolated communication error. Restart
ventilator.” re-appears transfer the patient to an alternative form of ventilation. Withdraw ventilator
from use. Route ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. If required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

Alarm message: Monitor isolated system error. Restart ventilator.


Alarm condition: Isolate system error Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 36
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: If the configuration data within the isolated side of the monitor subsystem is corrupted this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Manually ventilate the patient.
Step 2. Record the ventilator settings.
Step 3. Enter Standby mode and then restart the ventilator.
Step 4. Re-enter the mode of ventilation and reset the ventilator settings recorded prior to restart.
WARNING: If at this point the alarm message “Monitor isolated system error. Restart ventilator.” re-
appears transfer the patient to an alternative form of ventilation. Withdraw ventilator from use. Route
ventilator for repair.
Step 5. If required re-calibrate the flow sensor.
Step 6. IIf required turn on etCO2 / SpO2 monitoring.
Step 7. Reconnect the patient to the ventilator.
Step 8. Adjust ventilation parameters if required.

209
Technical data

Alarm message: Unable to calibrate flow ADC.


Alarm condition: Flow ADC unable to calibrate Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 37
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: During monitor subsystem flow calibration, if the signal levels are out of bounds this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.

Alarm message: Flow sensor is defective.


Alarm condition: Flow sensor defect Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 38
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If one of the flow sensor wires break this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor

Alarm message: Flow sensor is contaminated.


Alarm condition: Flow sensor is contaminated. Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 39
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If the measured flow is greater than 15 l/minfor 3.5 seconds this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor

Alarm message: Flow sensor is not connected.


Alarm condition: Flow sensor not connected. Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 40
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If the flow sensor is not connected or both wires have been broken this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor

210
Technical data

Alarm message: Unable to calibrate flow sensor.


Alarm condition: Unable to calibrate flow sensor Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 41
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If calibrating flow fails for any reason this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor. If alarm repeats transfer the patient to an alternative form of
ventilation. Withdraw ventilator from use. Route ventilator for repair.

Alarm message: Calibrate Flow Sensor.


Alarm condition: Flow sensor not calibrated Alarm type: Technical
Active in all modes with a flow sensor connected Alarm ranking: 42
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: The above alarm is generated whenever the ventilator is turned on or upon the re-connection of
the flow sensor.
Ventilator action: The ventilator will display this alarm message.
User action: Calibrate the flow sensor.

Alarm message: Flow Sensor Reversed.


Alarm condition: Flow Sensor Reversed Alarm type: Technical
Active in all modes with a flow sensor connected except HFO Alarm ranking: 43
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If the flow sensor is placed incorrectly in the circuit or the connecting wire is placed 180 degrees
out of phase to where it should go this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Re-fit flow sensor

Alarm message: Flow Sensor Clipping


Alarm condition: Flow sensor clipped Alarm type: Technical
Active in all modes with a flow sensor connected except HFO Alarm ranking: 44
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the flow through the flow sensor is greater than 30LPM for several breaths this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

211
Technical data

Alarm message: User interface has reset. Check Ventilator settings.


Alarm condition: The user interface has been reset Alarm type: Technical
Active in all modes Alarm ranking: 45
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: If the user interface subsystem resets this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action:
Step 1. Check the ventilator settings.
Step 2. Press reset to clear alarm message.
WARNING: If the alarm re-appears transfer the patient to an alternative form of ventilation. Withdraw
ventilator from use. Route ventilator for repair.

Alarm message: High Minute Volume


Alarm condition: High minute volume Alarm type: Patient
Active in all modes with a flow sensor connected except
Alarm ranking: 46
HFO+CMV. Not available in non-invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the minute volume is higher than the user set high minute volume threshold this alarm is
generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: High Patient Leak.


Alarm condition: Leak Alarm type: Patient
Active in all modes with a flow sensor connected except
Alarm ranking: 47
HFO+CMV, non-invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the calculated patient leak is above the user set alarm threshold this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Low Tidal volume


Alarm condition: Low tidal volume Alarm type: Patient
Active in all modes with a flow sensor connected except non-
Alarm ranking: 48
invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: Tidal volumes lower than the user selected threshold would generate this alarm.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

212
Technical data

Alarm message: High Tidal volume


Alarm condition: High tidal volume Alarm type: Patient
Active in all modes with a flow sensor connected except non-
Alarm ranking: 49
invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: Tidal volumes higher than the user selected threshold would generate this alarm.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Low Minute Volume


Alarm condition: Low minute volume Alarm type: Patient
Active in all modes with a flow sensor connected except non-
Alarm ranking: 50
invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the minute volume is lower than the user-set low minute volume threshold this alarm is
generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Breath Not Detected.


Alarm condition: Apnoea Breath Alarm type: Patient
Active in all modes with a flow sensor connected except non-
Alarm ranking: 51
invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If a breath is not detected within 20 seconds after the ventilator delivers a pressure cycle this
alarm will be generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Apnoea


Alarm condition: Apnoea volume Alarm type: Patient
Active in all modes with a flow sensor connected except non-
Alarm ranking: 52
invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If a flow trigger is not detected within the user set apnoea time this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

213
Technical data

Alarm message: Apnoea


Alarm condition: Apnoea pressure Alarm type: Patient
Active in all modes without a flow sensor connected. Alarm ranking: 53
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If a pressure trigger is not detected within the user set apnoea time this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: High Respiratory Rate.


Alarm condition: High BPM Alarm type: Patient
Active in invasive CPAP, PTV, PSV, SIMV and non Alarm ranking: 54
invasive NCPAP dual and single limb. Not available in
O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: This alarm is generated when the measured total BPM (RR) is more than the user set threshold.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Main Power Fail.


Alarm condition: Mains failure Alarm type: Technical
Active in all modes Alarm ranking: 55
Alarm type: Visual and audible Alarm priority: Low
Latching: No Alarm mutable: Yes
Definition: This alarm is generated when the mains voltage is removed from the ventilator.
Ventilator action: The ventilator will display this alarm message and switches to the internal power source.
User action: Restore mains power. Transfer the patient to an alternative form of ventilation.

Alarm message: O2 sensor disconnected. Please reconnect.


Alarm condition: Oxygen cell not connected Alarm type: Technical
Active in all modes Alarm ranking: 56
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: A disconnection of the oxygen cell will generate this alarm.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

214
Technical data

Alarm message: The oxygen cell needs calibrating.


Alarm condition: Oxygen cell needs calibrating Alarm type: Technical
Active in all modes Alarm ranking: 57
Alarm type: Visual and audible Alarm priority: Medium
Latching: Yes Alarm mutable: Yes
Definition: If at any time the measured oxygen is more than 100% this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Recalibrate the Oxygen. If the message returns transfer the patient to an alternative
form of ventilation. Withdraw ventilator from use. Route ventilator for repair.

Alarm message: A new oxygen cell is required.


Alarm condition: Oxygen cell needs replacing Alarm type: Technical
Active in all modes Alarm ranking: 58
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If the oxygen cell could not be calibrated during a calibration point this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for cell replacement.

Alarm message: O2 Calibration Fail


Alarm condition: O2 Calibration fail Alarm type: Technical
Active in all modes Alarm ranking: 59
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: If during 100% oxygen calibration the oxygen cell fails to see 100% oxygen this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.

Alarm message: High Oxygen Level.


Alarm condition: Oxygen too high Alarm type: Technical
Active in all modes Alarm ranking: 60
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the delivered oxygen is higher than the set oxygen level by more than 5% this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Recalibrate the Oxygen. If the message returns transfer the patient to an
alternative form of ventilation. Withdraw ventilator from use. Route ventilator for repair.

215
Technical data

Alarm message: Low Oxygen Level.


Alarm condition: Oxygen too low Alarm type: Technical
Active in all modes Alarm ranking:61
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the delivered oxygen is lower than the set oxygen level by more than 5% this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Recalibrate the Oxygen. If the message returns transfer the patient to an
alternative form of ventilation. Withdraw ventilator from use. Route ventilator for repair.

Alarm message: O2 > N%


Alarm condition: O2 greater then set percentage Alarm type: Technical
Active in OxyGenie® mode only Alarm ranking: 62
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: No
Definition: When OxyGenie® is active the user can set a delivered oxygen level above which they want to be
notified, default of 60, alarm delay is the same as SpO2 alarm delay.
N = User set percentage.
Ventilator action: The ventilator will display this alarm message.
User action: Check patient for change of underlying condition causing increased requirement for
oxygen, consider adjuring ventilator parameters. Check patient circuit for leak.

Alarm message: Internal communication fault. Remove ventilator from use.


Alarm condition: Can Display Congestion Alarm type: Technical
Active in all modes Alarm ranking: 63
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: If the data cannot be sent to the user interface subsystem this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.

Alarm message: OxyGenie is not available.


Alarm condition: PCLC failure Alarm type: Technical
Active in all modes Alarm ranking: 64
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: The PCLC sub-system sends life-ticks at regular intervals to the monitor. If the above life ticks are
interrupted for more than a prescribed time it will be assumed that the PCLC sub-system is not functioning
properly.
Ventilator action: The ventilator will display this alarm message.
User action: Manual titration/adjustment of oxygen is required. Route ventilator for repair when
convenient

216
Technical data

Alarm message: Check data output.


Alarm condition: MO hardware fault Alarm type: Technical
Active in all modes Alarm ranking: 65
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: No
Definition: ESMO not responding. The ESMO sub-system is to send life-ticks at regular intervals to the
monitor. If the above life ticks are interrupted for more than a prescribed time it will be assumed that the
ESMO sub-system is not functioning properly
Ventilator action: The ventilator will display this alarm message. On pressing reset the alarm message
becomes a status message that will remain visible whilst the ESMO is not responding.
User action:
With an external monitor device connected. Press the reset button and then check the external
monitors is still receiving data. If no data is being received disconnect the monitoring device.
Ventilation functionality is not affected. If the status message does not self-cancel and remains
present until the patient session has ended, route ventilator for repair.
Without an external monitor device connected. Press the reset button. Ventilation functionality is not
affected. If the status message does not self-cancel and remains present until the patient session
has ended, route ventilator for repair.

External sensor alarms


All external sensor alarms (etCO2 and SpO2) are ranked 66 when active.
See “Sensor Alarms” on page 222.

Alarm message: OxyGenie Unexpected reset


Alarm condition: PCLC has reset Alarm type: Technical
Active in all modes when Auto-O2 licence is present Alarm ranking: 67
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Definition: The UI checks the status of the PCLC, if the PCLC resets the UI will report this, the PCLC will be
in manual mode on reset
Ventilator action: The ventilator will display this alarm message.
User action: OxyGenie® has been set to manual due to a reset, reactivate OxyGenie® to continue
automatic adjustment of O2. Before re-initiating OxyGenie®, check that the O2 setting reflects the
patient’s current clinical condition to ensure that the control algorithm responds appropriately.
If the alarm persists, manual titration/adjustment of oxygen is required and route ventilator for repair
when convenient

Alarm message: Alarm system failure. Remove ventilator from use.


Alarm condition: Alarm generator error Alarm type: Technical
Active in all modes Alarm ranking: 68
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: The ventilator will display this alarm message and sound the backup sounder. The user cannot
cancel the backup sounder alarm tone. If a new alarm is generated the visual component of the alarm is
cancelled only.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

217
Technical data

Alarm message: Alarm system failure. Remove ventilator from use.


Alarm condition: Backup sounder fault Alarm type: Technical
Active in all modes Alarm ranking: 69
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the UI detects failure of the backup speaker. The alarm can be
only cleared by turning the ventilator OFF.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from use.
Route ventilator for repair.

Alarm Sound: Total power failure


Alarm condition: Total power failure Alarm type: Technical
- Alarm ranking: -
Alarm type: Audible only Alarm priority: High
Definition: When all internal power is exhausted this alarm is sounded.
Ventilator action: The ventilator will sound this alarm until the unit is turned off or the alarm power supply is
exhausted.
User action: Transfer the patient to an alternative form of ventilation.

218
Displayed

9
8
7
6
5
4
3
2
1

11

34
33
32
31
30
29
28
27
26
25
24
23
22
21
20
19
18
17
16
15
14
13
12
10
alarm Nº

One or both batteries

X
X
X
X
X
are not of the correct type

One or both batteries

X
X
X
X
X
X
X
X
X
X
X
X
X
X
are under 14.6V.

The batteries are

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
imbalanced

One or both

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
batteries are faulty.

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Incorrect PSU type
30.4 “Power supply fault” fault table

A fault code has been

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

returned by the PSU

219
Displayed
Technical data

63
62
61
60
59
58
57
56
55
54
53
52
51
50
49
48
47
46
45
44
43
42
41
40
39
38
37
36
35

alarm Nº

One or both batteries

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

are not of the correct type

One or both batteries

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
are under 14.6V.

The batteries are

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

imbalanced

One or both

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

batteries are faulty.

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

Incorrect PSU type

A fault code has been

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

returned by the PSU


Displayed

9
8
7
6
5
4
3
2
1

11

33
32
31
30
29
28
27
26
25
24
23
22
21
20
19
18
17
16
15
14
13
12
10
alarm Nº

Unable to send calibration

X
X
X
X
table

data to the isolated side


Pressure time constant

X
X
X
X
X
X
X
X
X
X
X
X
X
X
calibration values have been
corrupted.
Pressure gain calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
values have been corrupted

Pressure offset calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
values have been corrupted

Oxygen calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
values have been corrupted

Flow calibration values

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
30.5 “Ventilator out of calibration” fault

have been corrupted

220
Technical data

Displayed

63
62
61
60
59
58
57
56
55
54
53
52
51
50
49
48
47
46
45
44
43
42
41
40
39
38
37
36
35
34

alarm Nº

Unable to send calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

data to the isolated side


Pressure time constant

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
calibration values have been
corrupted.
Pressure gain calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

values have been corrupted

Pressure offset calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

values have been corrupted

Oxygen calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

values have been corrupted

Flow calibration values

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

have been corrupted


Technical data

30.6 “Controller hardware fault” fault 30.7 “Monitor hardware fault” fault table
table

8V standby error

8V standby error
Controller not

VREF error
responding

Displayed
Fresh gas
Displayed

Controller

Breath jet

3V3 error
alarm Nº
alarm Nº

module
Blender
module

module
reset

1 X 1 X
2 X 2 X
3 X X 3 X X
4 X 4 X
5 X X 5 X X
6 X X 6 X X
7 X X X 7 X X X
8 X 8 X
9 X X 9 X X
10 X X 10 X X
11 X X X 11 X X X
12 X X 12 X X
13 X X X 13 X X X
14 X X X 14 X X X
15 X X X X 15 X X X X
16 X
17 X X
18 X X
19 X X X
20 X X
21 X X X
22 X X X
23 X X X X
24 X X
25 X X X
26 X X X
27 X X X X
28 X X X
29 X X X X
30 X X X X
31 X X X X X

221
Technical data

31. Sensor Alarms


31.1 Alarm Priorities
Standard priorities for the external sensors when
both etCO2 and SpO2 sensors are connected.
When one alarm is presented to the user (according
to their respective priorities) from each external
sensors. The priories are as follows:

Priority 1. SpO2 system alarm


Priority 2. SpO2 patient alarm
Priority 3. etCO2 system Alarm
Priority 4. etCO2 patient Alarm

In general a SpO2 alarm has a higher priority than


etCO2 alarm.
However, under the following condition the etCO2
alarm becomes higher priority than spO2 alarm.

Priority 1. etCO2 patient alarm is active


Priority 2. SpO2 system alarm is active
Priority 3. etCO2 System alarm is not active

31.1.1 Status messages


Only one status message is presented from each
sensor with the following priority:

Priority 1. SpO2 alarm


Priority 2. etCO2 alarm
Priority 3. SpO2 status
Priority 4. etCO2 status

If etCO2 alarm has a higher priority than the SpO2


alarm then the priority would be:

Priority 1. etCO2 alarm


Priority 2. SpO2 alarm
Priority 3. etCO2 status
Priority 4. SpO2 status

222
Technical data

31.2 SpO2 monitoring (System alarms)

Alarm message: SpO2/etCO2 Hardware Fault


Alarm condition: Communication error Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 1
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Remove SpO2/etCO2 sensors or press “Continue Without external sensors” button.

Alarm message: No SpO2 Module Connected


Alarm condition: Module disconnected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 2
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Connect SpO2 sensor or turn OFF SpO2 monitoring.

Alarm message: SpO2 Hardware Fault - 1


Alarm condition: Module Fault/ Hardware failure Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 3
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor cable or remove SpO2 sensor cable and turn OFF SpO2 monitoring or
press “Continue Without SpO2 sensor” button.

Alarm message: SpO2 Hardware Fault - 2


Alarm condition: Demo Mode Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 4
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor cable or remove SpO2 sensor cable and turn OFF SpO2 monitoring or
press “Continue Without SpO2 sensor” button.

223
Technical data

Alarm message: SpO2 Hardware Fault - 3


Alarm condition: SpO2 module reset Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 5
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor cable or remove SpO2 sensor cable and turn OFF SpO2 monitoring or
press “Continue Without SpO2 sensor” button.

Alarm message: No SpO2 Sensor Connected


Alarm condition: No Sensor Connected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 6
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Connect SpO2 sensor or turn OFF SpO2 monitoring.

Alarm message: No SpO2 Cable Connected


Alarm condition: No Cable Connected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 7
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Connect SpO2 sensor or turn OFF SpO2 monitoring.

Alarm message: No Adhesive SpO2 Sensor Connected


Alarm condition: No Adhesive Sensor Connected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 8
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Connect Adhesive SpO2 sensor or turn OFF SpO2 monitoring.

224
Technical data

Alarm message: Defective SpO2 Sensor - 1


Alarm condition: Defective Sensor Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 9
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace SpO2 sensor

Alarm message: Defective SpO2 Sensor - 2


Alarm condition: Unrecognized sensor Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 10
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace SpO2 sensor

Alarm message: SpO2 Sensor Off Patient


Alarm condition: Sensor Off Patient Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 11
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Check sensor

Alarm message: SpO2 Sensor Interference Detected


Alarm condition: Interference Detected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 12
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Check sensor

Alarm message: Pulse Not Detected (SpO2)


Alarm condition: Pulse Not Detected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 14
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Check sensor

225
Technical data

31.3 SpO2 monitoring (Patient alarms)

Alarm message: High SpO2


Alarm condition: SpO2 High Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 1
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
The ventilator will display this alarm message and flash the SpO2 value in the monitored parameter display.
User action: Check patient/Check ventilation parameters

Alarm message: Low SpO2


Alarm condition: SpO2 low Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 2
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
The ventilator will display this alarm message and flash the SpO2 value in the monitored parameter display.
User action: Check patient/Check ventilation parameters

Alarm message: High Pulse Rate


Alarm condition: Pulse rate high Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 3
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
The ventilator will display this alarm message and flash the PR value in the waveform title bar.
User action: Check patient/Check ventilation parameters

Alarm message: Low Pulse Rate


Alarm condition: Pulse rate low Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 4
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
The ventilator will display this alarm message and flash the RR value in the waveform title bar.
User action: Check patient/Check ventilation parameters

226
Technical data

31.4 EtCO2 monitoring (System alarms)

Alarm message: SpO2/etCO2 Hardware Fault


Alarm condition: Communication error Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 1
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Remove SpO2/etCO2 sensors.

Alarm message: No etCO2 Module Connected


Alarm condition: Module disconnection Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 2
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Connect etCO2 sensor or turn OFF etCO2 monitoring.

Alarm message: etCO2 Module Fault - 1


Alarm condition: Module malfunction Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 3
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring or press “Continue Without etCO2 sensor” button.

Alarm message: etCO2 Module Fault - 2


Alarm condition: Invalid mode Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 4
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring.

227
Technical data

Alarm message: etCO2 Module Fault - 3


Alarm condition: Module reset Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 5
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring.

Alarm message: No etCO2 FilterLine connected


Alarm condition: FilterLine™ not connected Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 6
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Connect FilterLine™ or turn OFF etCO2 monitoring or press “Continue Without etCO2
sensor” button.

Alarm message: Replace etCO2 FilterLine


Alarm condition: Occlusion in gas input line Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 7
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace FilterLine™

Alarm message: etCO2 Module Fault - 4


Alarm condition: Temperature out of range Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 8
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring or press “Continue Without etCO2 sensor” button.

228
Technical data

Alarm message: etCO2 Module Fault - 5


Alarm condition: Check Flow Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 9
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring or press “Continue Without etCO2 sensor” button.

Alarm message: CO2 value over-range


Alarm condition: CO2 value over-range Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 10
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring.

Alarm message: Invalid CO2 Value


Alarm condition: Invalid CO2 Value Alarm type: Technical
Active in all modes: Yes when sensor connected Alarm ranking: 11
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Replace sensor module or remove etCO2 module and FilterLine™ and turn OFF etCO2
monitoring.

229
Technical data

31.5 EtCO2 monitoring (Patient alarms)

Alarm message: No etCO2 Breath


Alarm condition: No breath Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 1
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and show dashes in the monitored
parameter display.
User action: Check patient, Check FilterLine™. Check ventilation parameters.

Alarm message: High etCO2


Alarm condition: etCO2 High alarm Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 2
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and flash the etCO2 value in the monitored
parameter display.
User action: Check patient, Check ventilation parameters.

Alarm message: Low etCO2


Alarm condition: etCO2 Low alarm Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 3
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and flash the etCO2 value in the monitored
parameter display.
User action: Check patient, Check ventilation parameters.

Alarm message: High CO2


Alarm condition: CO2 High alarm Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 4
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and flash the CO2 value in the monitored
parameter display.
User action: Check patient, Check ventilation parameters.

230
Technical data

Alarm message: Low CO2


Alarm condition: CO2 Low alarm Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 5
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message and flash the CO2 value in the monitored
parameter display.
User action: Check patient, Check ventilation parameters.

Alarm message: High etCO2 Spont


Alarm condition: etCO2 Spont High alarm Alarm type: Patient
Active in all modes: Yes when sensor connected Alarm ranking: 6
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes
Ventilator action: The ventilator will display this alarm message.
User action: Check patient, Check ventilation parameters.

231
Technical data

32. Sensor Status messages


32.1 SpO2 Status messages

Status message: Too Much Ambient Light (SpO2)


Condition: Too Much Ambient Light Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 1
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message.
User action: Check sensor and reduce ambient light

Status message: Low Perfusion Index (SpO2)


Condition: Low Perfusion Index Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 2
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and flash the PI value in the waveform display.
User action: Check sensor, Check patient, Check ventilation parameters.

Status message: Pulse Search


Condition: Pulse Search Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 3
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and flash the SpO2 value in the monitored
parameter display.
User action: Check sensor, Check patient, Check ventilation parameters.

Status message: Low SpO2 Signal IQ


Condition: Low Signal IQ for more than 30 seconds Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 4
Alarm type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: Check sensor

232
Technical data

32.2 EtCO2 Status messages


Status message: etCO2 initializing
Condition: Start-up Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 1
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: Allow sensor module to start.

Status message: etCO2 Purge


Condition: Purge active Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 2
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: Allow sensor to complete purge cycle.

Status message: etCO2 Self Maintenance Mode


Condition: Self maintenance mode Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 3
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: Allow sensor to complete self maintenance mode.

Status message: etCO2 Pump OFF


Condition: Pump off Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 4
Message type: Visual and audible Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: Turn pump ON if required.

Status message: etCO2 Calibration Is Due


Condition: Calibration is due Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 5
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: None.

233
Technical data

Status message: etCO2 Maintenance Is Due


Condition: Maintenance is due Message type: Technical
Active in all modes: Yes when sensor connected Message ranking: 6
Message type: Visual Message priority: Low
Latching: No Message mutable: N/A
Ventilator action: The ventilator will display this message and show dashes in the monitored parameter
display.
User action: None.

234
Technical data

33. Cleaning and disinfection 6 Unlock the exhalation


block by turning the
The cleaning and disinfection instructions are for
clamp through 90
SLE6000’s external surfaces and the detachable
degrees until it is
components of the SLE6000 that are required to be
horizontal.
cleaned and disinfected after each patient use.

Note: All other accessories not listed here


can be cleaned in accordance with local
hospital guideline.
7 Gently pull away the
Note: For the etCO2 MicroPod™ module and exhalation block and
the uSpO2 cable (Masimo SET®) refer to the silencer from the gas
ports.
instructions for use supplied with the
respective device.

Components that can are in the gas pathway and


can become contaminated are:

Exhalation block 8 Separate the silencer


Silencer and exhalation block.
Gas jet ports
Occlusion valve



The ventilator’s external surface includes the back
surface of the ventilator, the screen, the metal plate
at the bottom of the ventilator, the metal cover and
the moulded case. 33.2 External surface cleaning
Detachable components are: the exhalation block instructions
and silencer. 1 Obtain three clean, disposable, absorbent non-
shedding cloths.
33.1 Instructions
2 Prepare a mild purpose detergent solution/ hand
Before cleaning or disinfecting the exterior of the hot water in a clean container.
ventilator the following tasks should be performed:
3 Wipe the ventilator’ external surface using mild
1 Disconnect the mains cable from the mains general purpose detergent solution/hand hot
supply. water with the first cloth.
2 Remove the patient circuit and bacterial filters. 4 If detergent was used for step 3, remove the
Discard any single use items as per appropriate detergent from the ventilator’ external surface
hospital authority guidelines. Reusable items using the second cloth with water only.
should be processed as per appropriate hospital
authority guidelines and the manufacturers’ 5 Wipe the ventilator’s external surface dry using
instructions. the third cloth.

3 Disconnect the gas supplies from the wall


outlets.
4 Disconnect the Oxygen and Air hoses from the
ventilator and cap the inlet ports.
5 Open the side flap.

235
Technical data

33.3 External surface disinfection 33.7 Gas jet ports disinfection


instructions 1 Obtain two clean, disposable, absorbent non-
1 Obtain two clean, disposable, absorbent non- shedding cloths.
shedding cloths. 2 Pour Alcohol (70% isopropanol) in a container.
2 Pour Alcohol (70% isopropanol) in a container.
3 Dampen one of the cloths in the Alcohol (70%
3 Dampen one of the cloths in the Alcohol (70%
isopropanol).
isopropanol).
4 Wipe the ventilator’s external surface with the 4 Wipe the two jet ports
alcohol-wetted cloth. with the alcohol-
5 Wipe the ventilator’s external surface dry using wetted cloth.
the second cloth. 5 Wipe the dry using
OR the second cloth.
6 Wipe the ventilator’s external surface using
Alcohol (70% isopropanol) wipes.
7 Allow to dry.
33.8 Occlusion valve
33.4 Exhalation block cleaning
instructions If the occlusion valve
which is internally
Note: For use of automatic washers please mounted is deemed to
follow hospital guidelines. have been contaminated
it can only be cleaned by
1 Prepare a mild purpose detergent solution/ hand a service technician as it
hot water in a clean container. requires ventilator
2 Wash the exhalation block in the mild general disassembly.
purpose detergent solution / hand hot water.
3 Rinse with sterile water. 33.9 Cleaning of main air intake filter.
4 Allow to dry. 1 Remove the fan filter guard (1). No tool required.
5 Check that the pressure relief valve ball rattle
when the exhalation block is shaken. If not 2
rewash and ensure any residue is removed that


may be sticking the balls in place.

33.5 Exhalation block disinfection


instructions 1
1 Pour Alcohol (70% isopropanol) in a container,
enough to submerge the exhalation block in it.
2 Immerse the exhalation block in Alcohol (70%
isopropanol) for 30seconds.
3 Allow to dry for an hour.
4 Autoclave with pure dry saturated steam at
134°C at 320kPa with a minimum holding time of
3 minutes or 121°C at 210kPa with a minimum 2 Remove the filter (2).
holding time of 15 minutes.
3 Wash the filter (2) in clean water.
33.6 Reusable Silencer disinfection Warning. Do not wring or deform the filter as
instructions this will cause it to loose its shape.
1 Steam disinfect with pure dry saturated steam at
134°C at 320kPa with a minimum holding time of 4 Dry the filter (2) between paper towels until no
3 minutes or 121°C at 210kPa with a minimum moisture is left.
holding time of 15 minutes 5 Replace the filter (2) and filter guard (1).

Note: The silencer can be steam disinfected


up to 25 times. Mark the silencer with a
suitable marker after each steam disinfection
cycle to indicate the number of cycles
completed.

236
Technical data

34. EMC compliance 34.2 Immunity tests compliance levels


Note: The emissions characteristics of this IEC61000-4-2:2008
equipment make it suitable for use in Electrostatic discharge
industrial areas and hospitals (CISPR 11 class Air discharge at 8kV and 15 kV
A). If it is used in a residential environment Contact discharge at 8kV
(for which CISPR 11 class B is normally
required) this equipment might not offer Indirect discharge at 8kV
adequate protection to radio-frequency IEC61000-4-3:2006 +A1:2007 +A2:2010
communication services. The user might Radiated RF electromagnetic fields
need to take mitigation measures, such as 80 - 2700 MHz in all planes
relocating or re-orienting the equipment.
Proximity fields from RF wireless equipment
TETRA 400 (380-390 MHz)
The SLE6000 was tested to IEC 60601-1-2:2015
complies to the following in relation to GMRS 460 and FRS460 (430-470 MHz)
Electromagnetic disturbances with no deviations. LTE bands 13 and 17 (704-787 MHz)

Based on the stated intended environment, the GSM 800/900, TETRA 800. iDEN 820, CDMA
ventilator has been classified as Group 1, Class A. 850, LTE Band 5 (800-960 MHz)
GSM1800, CDMA 1900, DECT, LTE Bands 1, 3,
4 & 15, UMTS (1700-1990 MHz)
34.1 Emissions test compliance levels
Bluetooth, WLAN 802.11b/g/n, RFID 2450, LTE
CISPR16-2-1:2008 +A1:2010 +A2:2013
Band 7 (2400-2570 MHz)
Mains terminal disturbance voltages
WLAN 802.11a/n (5100-5700 MHz)
240Vac at 50Hz
IEC61000-4-4:2012
110Vac at 60Hz Electrical fast transients and bursts
100Vac at 60Hz 2 kV AC input 240Vac 50Hz

CISPR16-2-3 :2010 +A1:2010 2 kV AC input 110Vac 60Hz


Electromagnetic radiation disturbances - 2 kV AC input 100Vac 60Hz
electric field
IEC61000-4-5:2014
30 MHz to 1 GHz - Vertical - 240Vac 50Hz
Surges
30 MHz to 1 GHz - Horizontal - 240Vac 50Hz AC input 240Vac 50Hz
30 MHz to 1 GHz - Vertical - 110Vac 60Hz AC input 110Vac 60Hz
30 MHz to 1 GHz - Horizontal - 110Vac 60Hz AC input 100Vac 60Hz
30 MHz to 1 GHz - Vertical - 100Vac 60Hz IEC61000-4-6:2013
30 MHz to 1 GHz - Horizontal - 100Vac 60Hz Conducted disturbances induced by RF fields
3 Vrms 240Vac 50Hz
IEC61000-3-2:2014
Harmonic current emissions 3 Vrms 110Vac 60Hz
230Vac at 50Hz IEC61000-4-8:2009
110Vac at 60Hz Power frequency magnetic fields
30 A/m 240Vac 50Hz
100Vac at 60Hz
30 A/m 110Vac 60Hz
IEC61000-3-3:2013
Voltage fluctuations and flicker IEC61000-4-11:2004
230Vac at 50Hz Volt age dips and short interruptions
AC input 240Vac 50Hz
110Vac at 50Hz
AC input 110Vac 60Hz
100Vac at 50Hz
AC input 100Vac 60Hz

237
Technical data

34.3 Warnings - EMC


1. Use of this equipment adjacent to or stacked
with other equipment should be avoided
because it could result in improper operation. If
such use is necessary, this equipment and the
other equipment should be observed to verify
that they are operating normally.

2. Use of accessories, transducers and cables


other than those specified or provided by the
manufacturer of this equipment could result in
increased electromagnetic emissions or
decreased electromagnetic immunity of this
equipment and result in improper operation.

3. Portable RF communications equipment


(including peripherals such as antenna cables
and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the
SLE6000, including cables specified by the
manufacturer. Otherwise, degradation of the
performance of this equipment could result.
34.4 Cautions - EMC
1. Only use the cables listed in chapter ’47.
Consumables & Accessories’ on page 254 for
connection to accessories or transducers.

238
Technical data

35. Pneumatic unit diagram Below is a schematic representation of the


pneumatic unit of the ventilator.
35.1 HFO capable pneumatic unit

239
Technical data

35.2 Conventional pneumatic unit Below is a schematic representation of the


pneumatic unit of the ventilator.

240
Technical data

35.3 Patient circuit pneumatic diagrams

241
Technical data

36. Software version identification


Below is a chart that allows the user to
identify the software version installed on the
ventilator.
System Version V2.0.97 V2.0.98

Subsystems

GUI software 2.0.36 2.0.36


User Preferences 2.0.14 2.0.14
UI Bios (Ventilator Serial Nº: 6XX01XXXXX,
V3.23#4 V3.23#4
6XX02XXXXX & 6XX03XXXXX)
UI Bios (Ventilator Serial Nº: 6XX04XXXXX) S1.63.4.0 S1.63.4.0
MMS software 2.0.54 2.0.54
MMS hardware 2 or C5 2 or C5
PCLC software 2.0.20 2.0.20
Controller software 217 217
Controller hardware 3 3
Monitor – Isolated SW 112 112
Monitor – Non Isolated 225 225
Monitor hardware 3 3
ESMO software MO 2.0.13 2.0.13
ESMO software ES 2.0.7 2.0.7
ESMO hardware 3,4 3,4
PSU software 1.0.3 1.0.3
PSU hardware 4.1 4.1
Alarm monitor software 1.4.0 1.4.0
Alarm UI software 1.4.0 1.4.0
Languages 2.0.29 2.0.29
Operating System Version (Ventilator Serial Nº:
2.0.2 2.0.2
6XX01XXXXX, 6XX02XXXXX & 6XX03XXXXX)
Operating System Version (Ventilator Serial Nº:
3.0.3 3.0.4
6XX04XXXXX)
System Update 2.1.4 2.1.4
Engineering Utility 2.0.16 2.0.16
Screen Calibration Utility 1.1.1 1.1.1

Caution. If the user finds a mis-match


of subsystem versions please do not
use the ventilator and refer it to a
qualified service technician.

242
Troubleshooting

Troubleshooting

243
Troubleshooting

37. Troubleshooting Chart


37.1 Ventilation Related Problems

Warning: In all alarm conditions check


the patient first.

Symptom Possible Cause Remedy

Alarm Message: Fresh gas supply tube blocked or Check the fresh gas supply line and
Blocked Fresh Gas. kinked. rest of the patient circuit.
Check patient circuit.
10mm circuit fitted but ventilator
invasive mode set to 15mm patient
circuit.

Patient circuit leaking fresh gas. Check the fresh gas supply line and
Alarm Message: rest of the patient circuit plus water
Leaking Fresh Gas. trap.
Check patient circuit.
15mm circuit fitted but ventilator
invasive mode set to 10mm patient
circuit.

Alarm Message: Constriction of proximal airway line. Remove constriction.


Continuing positive
pressure.

Alarm Message: Waveform has crossed high pressure Check ventilator pressures.
High Pressure threshold alarm threshold.
exceeded. Check the patient circuit.

Alarm Message: Waveform has crossed cycle fail alarm Check ventilator pressures.
Cycle Fail. threshold.
Check the patient circuit and water
trap.

Waveform has crossed low pressure Check ventilator pressures.


Alarm Message: alarm threshold. Check the patient circuit and water
Low Pressure. trap.
Adjust alarm threshold.

Alarm Message: The mean pressure has increased by Check ventilator pressures.
Unexpected rise in mean more than 5mbar. Check the patient circuit.
pressure. Press autoset to for new alarm
thresholds.

Alarm Message: The mean pressure has decreased by Check ventilator pressures.
Unexpected drop in more than 5mbar. Check the patient circuit and water
mean pressure. trap.
Press autoset to for new alarm
thresholds.

Alarm Message: The maximum pressure has increased Check ventilator pressures.
Unexpected rise in delta by more than 5mbar. Check the patient circuit.
pressure. Press autoset to for new alarm
thresholds.

244
Troubleshooting

Symptom Possible Cause Remedy

Alarm Message: The maximum pressure has Check ventilator pressures.


Unexpected Drop in decreased by more than 5mbar. Check the patient circuit and water
Delta Pressure. trap.
Press autoset to for new alarm
thresholds.

Alarm Message: Flow sensor has become encrusted Remove sensor from patient circuit.
Flow sensor is with secretions. Fit new flow sensor and calibrate.
contaminated. Refit sensor into patient circuit.
If no replacement sensor available
press “Continue without flow” and set
breath trigger sensitivity.

Alarm Message: The minute volume trend has crossed Check ventilator pressures.
High Minute Volume. the high minute volume alarm Check the patient circuit.
threshold. Set new alarm threshold.

Alarm Message: The minute volume trend has crossed Check ventilator pressures.
Low Minute Volume. the low minute volume alarm Check the patient circuit.
threshold. Set new alarm threshold.

Alarm Message: The calculated percentage of patient Check the patient circuit.
High Patient Leak. leak has crossed the alarm threshold. Set new alarm threshold.

Alarm Message: The tidal volume waveform has Check the patient.
Low Tidal Volume. crossed the low tidal volume alarm Check the patient circuit and water
threshold. trap.
Set new alarm threshold.

Alarm Message: A breath has not been detected by the Set new breath detection threshold or
Apnoea. ventilator. breath trigger sensitivity.

Check the patient circuit.

Alarm Message: ET tube blocked or disconnected. Check the patient for air entry.
Breath Not Detected. Check the patient circuit.

Preview mode cancels. The preview mode self cancels after Re-select preview mode.
120 seconds if no button presses are
made.

245
Troubleshooting

37.2 Ventilator Related Problems

Warning: In all alarm conditions check


the patient first.

Symptom Possible Cause Remedy

Ventilator screen Display failure. Refer ventilator to qualified service


remains blank on power personnel.
up. Power button halo is
green.

Ventilator screen blank Display failure. Remove patient to alternative form of


with alarm tone being ventilation, then remove ventilator
generated. Ventilator from service.
continuing to ventilate.
Refer ventilator to qualified service
personnel.

Ventilator screen blank. Complete power failure. Remove patient to alternative form of
Power button halo is Off. ventilation, then remove ventilator
Continuous alarm tone from service.
being generated.

Touchscreen buttons do Touching the screen at two points. Touch the screen at one point only
not operate as expected.
Touchscreen out of alignment. Refer ventilator to qualified service
personnel.

Touchscreen buttons do Touchscreen failure. Remove patient to alternative form of


not operate. ventilation, then remove ventilator
from service.

Refer ventilator to qualified service


personnel.

Total power fail alarm Power button not re-pressed on power Re-press button fully to cancel alarm.
active (Audible only) down.
after turning off the
ventilator.

Alarm Message: No Air and Oxygen supplies not Check Air and Oxygen
Gas. connected to ventilator. supplies/connections.

Air and Oxygen supply failed. If generated whilst connected to a


patient, remove patient to alternative
form of ventilation.

Leaking fresh gas alarm Air and Oxygen supply failed. If generated whilst connected to a
with CPAP/PEEP/Mean patient, remove patient to alternative
at zero and PIP/Delta P form of ventilation.
at zero.
Alarm Message: Check Air and Oxygen
Leaking Fresh Gas. supplies/connections.
Check patient circuit.

246
Troubleshooting

Symptom Possible Cause Remedy

Low pressure alarm with Air and Oxygen supply failed. If generated whilst connected to a
CPAP/PEEP/Mean at patient, remove patient to alternative
zero and PIP/Delta P at form of ventilation.
zero.
Alarm Message: Check Air and Oxygen
Low Pressure. supplies/connections.

Alarm Message: Oxygen supply not connected to Check Oxygen supply/connections.


No O2 Supply. ventilator.
If generated whilst connected to a
Oxygen supply failed. patient, remove patient to alternative
form of ventilation.

No Air supply alarm. Air supply not connected to ventilator. Check Air supply / connections.
Alarm Message:
No Air Supply. Air supply failed. If generated whilst connected to a
patient, remove patient to alternative
form of ventilation.

Battery fault alarm. The internal battery has failed or the Remove ventilator from service.
Alarm Message: power supply has developed a fault. Note alarm message and refer
Battery Fault. ventilator to qualified service
personnel.

Battery Low alarm. Battery has reached 25% charge level. Restore mains power.
Alarm Message: If mains power cannot be restored,
Battery Low. remove patient to alternative form of
(Medium priority) ventilation.
Note alarm message and refer
ventilator to qualified service
personnel.

Battery Low alarm. Battery has reached 10 minute Restore mains power.
Alarm Message: operation. If mains power cannot be restored,
Battery Low. remove patient to alternative form of
(High priority) ventilation.
Note alarm message and refer
ventilator to qualified service
personnel.

Pressure sensor drift A pressure sensor transducer has Remove ventilator from service.
alarm. failed an internal system check. If generated whilst connected to a
Alarm Message: patient, remove patient to alternative
Pressure sensor fault form of ventilation
remove ventilator from Note alarm message and refer
use. ventilator to qualified service
personnel.

247
Troubleshooting

Symptom Possible Cause Remedy

Alarm Message: Faulty A flow sensor heated wire has broken. Remove sensor from patient circuit.
Flow Sensor. Discard the flow sensor.
Fit new flow sensor and recalibrate.

Refit sensor into patient circuit.


If no replacement sensor available
press “Continue without flow” and set
breath trigger sensitivity.

If message continues, remove patient


to alternative form of ventilation, then
remove ventilator from service.
Note alarm message and refer
ventilator to qualified service
personnel.

Alarm Message: Flow sensor cable not connected to Connect flow sensor cable and
Connect Flow Sensor. ventilator. recalibrate flow sensor. Refit sensor
into patient circuit. If to be used without
sensor press “Continue without flow”
and set breath trigger sensitivity.

Remove sensor from patient circuit.


If sensor connected, both heated wires Discard the flow sensor.
broken. Fit new flow sensor and recalibrate.
Refit sensor into patient circuit.
If no replacement sensor available
press “Continue without flow” and set
breath trigger sensitivity.

Alarm Message: New sensor connected to ventilator. Carry out calibration routine.
Calibrate Flow Sensor. Fit sensor into patient circuit.

Alarm Message: Internal hardware reset has occurred. Remove ventilator from service.
User interface has reset. If generated whilst connected to a
Confirm settings patient, remove patient to alternative
form of ventilation
Note alarm message and refer
ventilator to qualified service
personnel.

Alarm Message: The oxygen sensor cell has become Remove patient to alternative form of
O2 sensor disconnected. ventilation, then remove ventilator
disconnected. Please from service.
reconnect.. Note alarm message and refer
ventilator to qualified service
personnel.

Calibrate Oxygen cell The oxygen sensor has registered Recalibrate O2 sensor.
alarm. >100% oxygen concentration.
Alarm Message: If sensor at fault a new oxygen cell
The Oxygen Cell needs alarm will be generated. If this
calibrating. messages appears remove patient to
alternative form of ventilation, then
remove ventilator from service.
Note alarm message and refer
ventilator to qualified service
personnel.

248
Troubleshooting

Symptom Possible Cause Remedy

Oxygen calibration During the oxygen sensor calibration Remove patient to alternative form of
failure. the ventilator could not achieve a ventilation, then remove ventilator
Alarm Message: reading of 100% oxygen. from service.
O2 Claibration Fail
Note alarm message and refer
ventilator to qualified service
personnel.

Monitor/Display Comms A hardware/software fault has Remove patient to alternative form of


fail alarm. developed within the ventilator. ventilation, then remove ventilator
Alarm Message: from service.
Internal communication Note alarm message and refer
fault. Remove ventilator ventilator to qualified service
from use. personnel.

High or low pressure A hardware fault has developed within a) Check the alarm thresholds are set
alarm with fresh gas the pneumatic unit of the ventilator. correctly.
cut off.
b) Press the Reset button to restart
Pressure spike of ventilation.
20mbar or greater
followed by no fresh gas. If the pressure spike is generated the
ventilator will cut all gases again.
Alarm Message:
High Pressure threshold c) Remove the patient immediately to
exceeded. or Low an alternative form of ventilation.
Pressure.
d) Remove the ventilator from service
and refer ventilator to qualified service
personnel.

37.3 Sensor Related Problems

Warning: In all alarm conditions check


the patient first.
etCO2 sensor

Symptom Possible Cause Remedy

Alarm Message: Blocked filterline First disconnect and reconnect the


Replace etCO2 filterline FilterLine™. If the message still
appears, disconnect and replace the
FilterLine™. Once a working
FilterLine™ is attached to the module,
the pump will automatically resume
operation.

249
Troubleshooting

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250
PPM & Functional testing

PPM & Functional testing

251
PPM & Functional testing

38. Planned preventative 38.2.2 Kit B


Proportional valve kit (3 valves) Qty. 1
Maintenance (PPM)
High speed valve assembly Qty. 1
Warning. Planned preventative Maintenance
of this ventilator should only be carried out Each PPM kit will require the installation of the
by a SLE trained hospital engineer or an SLE above parts and a re-calibration.
service engineer.
38.3 Kit part numbers
38.1 PPM schedule Kit A N9610/A
Kit B N9610/B
Year Use PPM Use PPM
Note: A service manual is available for use by
KIt A kit B*
qualified engineers who have been trained by
1 A SLE on this product.

2 A The service manual contains full illustrated


parts list, circuit diagrams, pneumatic
3 A diagrams and calibration procedure for the
ventilator.
4 A
Contact SLE or your distributor for further
5 A
information.
6 A B*
38.4 Mains cable replacement
7 A
Warning. The replacement of the mains cable
8 A should only be carried out by a SLE trained
9 A hospital engineer or an SLE service engineer.

10 A Remove the two screws (A) to release the clamp


(B).

*Note: Kit B shall be used at 6 years or 30,000


hours, which ever is sooner. The time in C
hours should be taken from the hour counter

mounted in the rear of the pneumatic chassis.

The hour counter only records the time the


ventilator is in operation i.e. turned on.

38.2 PPM kits B


The SLE6000 has two PPM kits, A & B.


38.2.1 Kit A A
Kit contains the following.
Oxygen sensor cell Qty. 1 Remove the mains cable (C).

Conical filter Qty. 2 Only replace the cable with one of the following
Duckbill valve Qty. 2 cables available from SLE:
Duckbill washer Qty. 2 Mains cable 3M long UK 3 pin plug. P/Nº:M0255/
“O” rings Qty. 2 095
Orifice block “O” rings Qty. 2
Mains cable 3M long Shuko plug. P/Nº:M0255/096
Particulate filters 5μm Qty. 2
Mains cable 3M long NEMA plug. P/Nº:M0255/097

252
PPM & Functional testing

38.5 MicroPod™ PPM 39. Ventilator Functional testing


A calibration should be performed after the initial Functional testing can be performed if the user
1,200 hours of use, and following that calibration wants to check the operation of the alarms or the
once a year or every 4,000 operating hours, basic performance of the ventilator.
whichever comes first. Functional testing is broken down into two sections,
alarm testing and performance testing.
After 30,000 operating hours, certain components of
the capnography module need servicing. Only a
39.1 Alarm testing
trained technician can provide this service. Consult The alarm test routine allows the user to
SLE or your distributor for more information. test the essential performance of the
following alarms:
The ventilator will display from the etCO2 sensor tab
Alarm type Alarm message
the following information:
High Oxygen High oxygen level
Date of last calibration Low Oxygen Low oxygen level
Date of next calibration
Date of next service PEEP alarm CPAP to high/
PEEP to high
Note: A service manual is available for use by Obstruction alarm Blocked fresh gas
qualified engineers who have been trained by
Partial occlusion alarm Continuing positive
SLE on this product.
pressure
Order SM38 issue 5 or higher Expired volume alarm Tidal volume above
The service manual contains the calibration high threshold
procedure for the MicroPod™. Low volume alarm Minute volume
below low threshold
Calibration of the MicroPod™ requires the
use of a calibration Gas. Power supply failure alarm Main power fail

Contact SLE or your sales distributor for Loss of gas supply alarm No air supply
further information. No O2 supply
High Pressure alarm High pressure
threshold exceeded
1 Use the standard ventilator set up as
described in “Ventilator basic setup” on
page 42.
2 Connect a full patient circuit and test lung.
Warning: The patient circuit used for
functional testing must not be used for
patient ventilation.

3 Select and enter CMV mode.


4 Ensure that the oxygen system has completed
its calibration.

39.1.1 High Oxygen/Low Oxygen/Loss of gas


supply alarm test
1 Set the O2 control to 21%.
2 Disconnect the Air supply. (The ventilator will
now switch to 100% oxygen).
3 The loss of air supply alarm will now trigger
(Message “No Air Supply”).
4 Allow the O2 measured value to reach 100%.
5 Reconnect the Air supply.

253
PPM & Functional testing

6 The High oxygen alarm (Message “High 39.1.5 Expired volume alarm - Tidal volume
Oxygen level”) will be triggered. above/below threshold
7 Set the O2 control to 25%. 1 Change mode to HFO.
8 Disconnect the oxygen supply. (The ventilator 2 Set the ΔP to 80 mbar.
will now switch to 100% air).
3 Open the alarm panel.
9 The loss of oxygen supply alarm will now
4 Reduce the upper Vte alarm threshold to
trigger (Message “No O2 supply”).
below the measured value.
10 Disconnect the air supply
5 Wait for approximately 20 seconds and the
11 The loss of gas supply alarm will now trigger high expired volume alarm will now trigger,
(Message “No Gas”). (Message “Tidal volume above high
threshold”).
12 Reconnect both gases.
6 Return the high alarm threshold to 30 ml.
39.1.2 Obstruction alarm - Blocked fresh gas
7 Reset any alarm messages.
1 Still in CMV mode remove the inspiratory
supply line and obstruct the “Fresh gas to 8 Increase the lower Vte alarm threshold to
Patient” port. above the measured value.

2 Press the reset button until the “Blocked fresh 9 Wait for approximately 20 seconds and the low
Gas” alarm appears. expired volume alarm will now trigger,
(Message “Tidal volume below low threshold”).
3 Reconnect the inspiratory supply line and reset
all alarm messages. 10 Return the low alarm threshold to 0 ml.
11 Reset any alarm messages.
39.1.3 Partial occlusion alarm - Continuing
positive pressure 39.1.6 Volume alarm - Minute volume above/
1 Change mode to CPAP below threshold

2 Gently constrict the exhalation limb tube to 1 Reduce the upper Vmin alarm threshold to
increase the measured pressure to just under below the measured value.
the high PIP alarm threshold. Ensure that the 2 Wait for approximately 20 seconds and the
pressure waveform does not cross the High high minute volume alarm will now trigger,
PIP alarm threshold. (Message “Minute volume above high
3 The partial occlusion alarm will now trigger, threshold”).
(Message “Continuing positive pressure”)and 3 Return the high alarm threshold to 18 l.
the gases will be cut.
4 Increase the lower Vmin alarm threshold to
Note: The CPAP to high alarm will be above the measured value.
triggered first but will then be overridden
by the Continuing positive pressure 5 Wait for approximately 20 seconds and the low
alarm minute volume alarm will now trigger,
(Message “Minute volume below low
4 Release the constriction from the exhalation threshold”).
limb tube. 6 Return the low alarm threshold to 0 l.
39.1.4 High Pressure alarm - High pressure
39.1.7 Power supply failure alarm - Main power
threshold exceeded
fail and battery check
1 Block the proximal airway line by creating a
1 Disconnect the mains power by removing the
folding the line over.
plug from the supply socket.
2 The pressure waveform should increase above
2 The power supply failure alarm will now trigger,
the high PIP alarm threshold.
(Message “Main power fail”).
3 The high pressure alarm will now trigger,
3 Check that the AC symbol is no longer present,
(Message “High Pressure Threshold
symbol located next to battery icon.
Exceeded”).
4 Reconnect the mains power by inserting the
plug into the supply socket.
5 The alarm message will cancel.

254
PPM & Functional testing

6 Check that the AC symbol is present, symbol


located next to battery icon. Warning: If any of the above test fail do not
7 Ensure that the ventilator continues to operate use the ventilator but withdraw it from service
normally. and refer it to qualified service personnel for
repair/re-calibration.
8 Ensure a battery percentage is displayed.
9 Change mode to CMV.

39.2 Performance testing.


The performance test is divided into two steps,
conventional and oscillatory.

39.2.1 Conventional
1 Remove the flow sensor form the ET
manifold and occlude the ET
manifold.
2 Disconnect the flow sensor and press
“Continue without flow sensor”.
3 Set the following:
RR 30 BPM
Ti 1 second
PEEP 0 mbar
PIP 15 mbar
4 Confirm that the measured PIP is 15 mbar ± 1
mbar.
5 Confirm that the measured PEEP is 0 mbar± 1
mbar.

39.2.2 Oscillatory
1 Change mode to HFO.
2 Set the following:
Frequency 5 Hz
I:E ratio 1:1
MAP 0 mbar
ΔP 20 mbar
3 Confirm that the measured MAP is 0 mbar + 1
mbar.
4 Set the ΔP to 150 mbar
5 Confirm that the measured MAP is 0 mbar + 5
mbar.
6 Set the ΔP to 180 mbar
7 Confirm that the measured ΔP is >150 mbar.
8 Confirm that the measured MAP is 0 mbar + 12
mbar.
9 Set the ventilator to standby
10 Remove the test circuit.
11 Functional testing is now complete.

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PPM & Functional testing

40. External sensor functional 6 Reset the Low Threshold below the measured
value.
testing
7 Decrease the SpO2 high alarm threshold
40.1 Masimo SET® above the measured SpO2 value.
1 Use the standard ventilator set up as
8 Wait for the SpO2 high alarm to be triggered.
described in “Ventilator basic setup”
on page 42. 9 Reset the Low Threshold below the measured
2 Connect a full patient circuit and test lung. value.

Warning: The patient circuit used for 10 Reset all alarm messages.
functional testing must not be used for 11 Press the “Layout” button.
patient ventilation.
12 Select "Waveforms" and press Edit.
3 Do not connect a flow sensor. 13 Set the SpO2 waveform to ON and press the
40.1.1 Masimo SET® Functional testing confirm button.

Note: To test the alarms the user will have to 14 Increase the PR low alarm threshold above the
user one of the following sensors Masimo Inf- measured PR value displayed in the waveform
3 or Masimo Neo-3 or Masimo NeoPt-3. title bar.
15 Wait for the PR low alarm to be triggered.
1 Setup the Masimo sensor as described in
16 Reset the Low Threshold below the measured
section ’17.2 Masimo SET® Connection’ on
value.
page 99.
17 Decrease the PR high alarm threshold above
2 From the “Utilities” Sensor tab press the SpO2
the measured PR value.
button.
18 Wait for the PR high alarm to be triggered.
3 Turn on SpO2 monitoring.
19 Reset the Low Threshold below the measured
4 Select CMV mode. value.
5 Press “Continue Without Flow sensor” button. 20 The SpO2 alarms test are now complete.
6 Reset all alarm messages.
7 Press the “Alarm” button and select the
“Current” tab.
8 The message “Sensor Off patient” should be
displayed.
9 Disconnect the sensor from the adaptor cable.
10 The “No SpO2 Sensor connected” alarm
should appear.
11 Reconnect the sensor and the message
should return to “Sensor Off patient”.

40.1.2 Masimo SET® SpO2 and PR alarms


1 The user should apply the selected sensor to a
finger.
2 Wait for the ventilator to display the measured
SpO2 reading.
3 Enter the alarm panel.
4 Increase the SpO2 low alarm threshold above
the measured SpO2 value.
5 Wait for the SpO2 low alarm to be triggered.

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PPM & Functional testing

40.2 MicroPod™ 9 Reset the Low Threshold below the measured


1 Use the standard ventilator set up as value.
described in “Ventilator basic setup” 10 Reset all alarm messages.
on page 42.
11 The etCO2 alarm test is now complete.
2 Connect a full patient circuit and test lung.
Warning: The patient circuit used for
functional testing must not be used for
patient ventilation.

3 Do not connect a flow sensor.

40.2.1 MicroPod™ Functional testing


Note: To test the alarms the user will have to
user a compatible FilterLine™.

1 Setup the MicroPod™ as described in section


’17.11 EtCO2 monitoring (MicroPod™)’ on
page 104.
2 From the “Utilities” Sensor tab press the etCO2
button.
3 Turn on etCO2 monitoring.
4 Select CMV mode.
5 Press “Continue Without Flow sensor” button.
6 Reset all alarm messages.
7 Press the “Alarm” button and select the
“Current” tab.
8 The message “Sensor Off patient” should be
displayed.
9 Disconnect the sensor from the adaptor cable.
10 The “No SpO2 Sensor connected” alarm
should appear.
11 Reconnect the sensor and the message
should return to “Sensor Off patient”.

40.2.2 MicroPod™ etCO2 alarm


1 The user should blow into the filter line.
2 Continue to blow until the ventilator displays
the measured etCO2 reading.
3 Enter the alarm panel.
4 Increase the etCO2 low alarm threshold above
the measured etCO2 value.
5 Wait for the etCO2 low alarm to be triggered.
6 Reset the Low Threshold below the measured
value.
7 Decrease the etCO2 high alarm threshold
above the measured etCO2 value.
8 Wait for the etCO2 high alarm to be triggered.

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PPM & Functional testing

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258
Installation instructions

Installation instructions
“Unpacking.” on page 260

“Medicart assembly” on page 261

“Ventilator unpacking” on page 262

“Ventilator assembly to Medicart” on page 263

“Mains cable attachment” on page 264

“Pre-use functional test.” on page 264

“Ventilator configuration” on page 264

259
Installation instructions

41. Installation instructions 41.1 Unpacking.


The following installation instructions allow the user 1. Place the shipping carton on a flat surface with
to assemble the ventilator and functionally test the access to all sides.
ventilator.

Warnings:
The ventilator should be commissioned only
by qualified service personnel.

Warnings:
A complete ventilator-trolley shipping carton
weighs approximately 60kg.and requires 2
person lifting.
The Ventilator carton weighs approximately
25 kg and removal from the shipping carton
requires 2 person lifting.
The ventilator weighs 22kg ±0.5kg. Failure to
secure the ventilator to the trolley can cause
the ventilator to fall off when in transit.
2. Open the top of the shipping carton and remove
Failure to secure the mains inlet cable to the the packing strips (A, B & C), this is to allow access
ventilator can cause the mains to be to the lifting handle for the ventilator carton.
disconnected whilst in use.
Failure to secure either the mains cable or the
ventilator, places the machine in an unsafe A



state, and the ventilator should not be used B
until these two items are rectified.


C
The following is the order for installation.
A. Unpacking
B. Trolley assembly.
C. Ventilator mounting.
D. Ventilator setup.

Note: The ventilator is supplied with a


commissioning procedure in the accessories
box.

41.0.1 Tools required for trolley assembly


5mm A/F Allen key Qty. 1
3mm A/F Allen key Qty. 1
Pozi drive screwdriver Qty. 1 Note: The packing strip (C) may be replaced
by a humidifier heater base.

Note: Accessory bags may be inserted into


the voids.

260
Installation instructions

3. Remove the ventilator carton by using the lifting 41.2 Medicart assembly
handles.
41.2.1 Medicart kit contents

D Top plate assembly ..................Qty. 1


Support column .........................Qty. 1
Base plate with castors .............Qty. 1
Hose hook .................................Qty. 1
Humidifier mount .......................Qty. 1


E Screws M6 button head ............Qty. 6
Washers ....................................Qty. 6
Screws M6 Countersunk head ..Qty. 10

41.2.2 Assembly
1. Attach support column to wheel base using 6
button head screws and spring washers. Ensure the
basket support (A) faces the towards the locking
castors (B) of the base.


B

Note: This step requires two person lifting


from points D and E. A
4. Remove the Medicart carton from the base of the
box.

F

Note: This step requires two person


assembly.

Note: This step requires two person lifting


from points F and G.

5. The next stage is to assemble the Medicart.

261
Installation instructions

2. Rotate the base and column and lock the front 41.3 Ventilator unpacking
wheels. Attach top plate (C) to the centre column
1. Place the ventilator carton on a flat stable
using 6xM6 countersunk screws (D). surface.


D

2. Remove the packing tape securing the top flaps


and open the flaps fully.
3. Remove the accessories (A) packed in the two
pockets of the large insert.

A
3. Attach hook (E) to the column with 2xM6 A
countersunk screws. Slide the basket (F) into the
lower accessory mount, an optional set screw is
supplied for locking.


E

F 4. Remove the upper foam insert (B) and the two


cardboard inserts (C & D).

K C J



B

262
Installation instructions

5. Lift the ventilator out of the base foam pad using 41.5 Ventilator assembly to Medicart
the rear lift point (E) and the front lift point (F). The
Place the ventilator on the Medicart.
front lift point (F) is the scoop at the front of the
ventilator which is partly covered by the support
foam.

E

F


A

6. Place the ventilator of a stable flat surface and


remove the protective film. Remove the two red
protective caps (G).

Ensure that all the feet protrude through base tray


holes.Secure the ventilator by using the captive
screw (A) located on the underside of the base

plate.
G
The ventilator is now ready to be mounted to the
Medicart. If the ventilator is not to be mounted on a
Medicart then advance to section 41.6 “Mains cable
attachment” .

Note: Retain the packaging for future use.

41.4 Ventilator lifting points


The following are the lifting points for the ventilator.

The front scoop and the rear handle.

263
Installation instructions

41.6 Mains cable attachment 41.7 Pre-use functional test.


The mains cable need to secured via the attached Carry out the “Ventilator basic setup” on page 42
clamp.. and the “Functional testing (Invasive dual limb)” on
page 45.
41.8 Ventilator configuration
The ventilator is shipped with factory defaults as
listed in the technical specification. The user can
configure the ventilator by setting the user defined
features from the user preference application. See
“User preferences” on page 266.
A


B
Note: The mains lead is found in the
accessories pack supplied with the ventilator

Remove the cable clamp (A) by removing the two


screws (B).

Insert the mains cable (C) into the inlet socket.

C

A

Secure the cable by refitting the cable clamp (A)


using the two screws (B).

264
User preferences

User preferences
“Accessing user preferences” on page 266
“Parameters tab” on page 266
“Ventilation tab” on page 267
“Alarms tab” on page 267
“Interface tab” on page 268
“Regional tab” on page 268
“Save / Quit tab” on page 268

265
User preferences

42. User preferences 42.1.1.1 Parameters


From this panel the following can be set.
This section describes all the features of the user
preference interface.
Note: User preferences can only be selected
from “Standby mode”.

42.1 Accessing user preferences


To access user preferences select “Utilities” or
“Calibration/Utilities” > “System” > “User
preferences”.
The user preferences number pad will be displayed.

Default ventilation mode.


RR (BPM) Range 1 to 150 BPM1
Default 30 BPM
Ti (seconds) Range 0.1 to 3 seconds2
Default 0.4 seconds
PIP (mbar) Range 0 to 65 mbar3
Default 15 mbar
PEEP (mbar) Range 0 to 35 mbar4
Default 4 mbar
O2% Range 21 to 100 %
Default 21%
Enter the default code of 0420 and press the VTe Target (ml) Range 2 to 300 ml
confirm button.The user will now be presented with Default 3 ml
the user preferences “Parameters” tab as the
default. I:E ratio 1:1, 1:2 & 1:3
Default 1:1
42.1.1 Parameters tab Trigger
Form this tab the user can select the following: sensitivity (l/min) 0.2 to 20 l/min
Default 0.6 l/min
Parameters - Setting user defaults for power up. Apnoea backup
Ventilation - Setting of ventilation pre-sets RR (BPM) 1 to 150 BPM
Default 40 mbar
Alarms - Setting of alarm defaults.
MAP (mbar) 2 to 45 mbar
Interface - Setting of interface defaults.
Default 5 mbar
Regional - Setting on Language and units.
Frequency (Hz) 3 to 20 Hz
Save/Quit - Save settings and factory reset. Default 10 Hz
SpO2 target range 90-94%
91-95% Default
92-96%
94-98%

Note1: This parameter is limited by the set Ti.


Note2: This parameter is limited by the set RR.
Note3: This parameter is limited by the set
PEEP.
Note4: This parameter is limited by the set
PIP.

266
User preferences

42.1.2 Ventilation tab 42.1.3 Alarms tab


The ventilation tab sets the preference for features The alarm tab sets the preference for default limits
available in a ventilatory mode. for the displayed alarms available in a ventilatory
mode.

Manual breath maximum hold - Set Ti, 5 seconds


and 10 seconds. (Default set Ti)
High RR (BPM) - Range 0 to 150 BPM (Default 100
Manual sigh maximum hold - Set Ti, 5 seconds and BPM).
10 seconds. (Default set Ti)
High minute volume Conventional (ml) - Default
O2 Boost5 - ON or OFF (Default OFF) 18000 ml.

O2 Suction5 - ON or OFF (Default OFF) Low minute volume Conventional (ml) - Default 0
ml.
Pre-Set O2 for O2 Boost or O2 Suction - 100% or
adjustable from 1 to 10% (Default 5%) High minute volume HFO (ml) - Default 18000 ml.

Low minute volume HFO (ml) - Default 0 ml.


Note5: Only one function can be enabled. If Apnoea time (sec) - Range 5 to 60 sec (Default
the user turns on one function then tries to 15sec).
turn on the other the first active function is High SpO2 - Range 6 to 99 % (Default 99%) limited
automatically turned OFF.
by Low SpO2 value.
Low SpO2 - Range 5 to 98 % (Default 89%) limited
by High SpO2 value.
High Pulse rate (BPM) Range 31 to 235 BPM
(Default 180 BPM) limited by Low Pulse rate value.
Low Pulse rate (BPM) Range 30 to 234 BPM
(Default 100 BPM) limited by High Pulse rate value.
High etCO2 (mmHg) Range 10 to 95 mmHg (Default
50 mmHg) limited by Low etCO2 value.
Low etCO2 (mmHg) Range 5 to 90 mmHg (Default
20 mmHg) limited by High etCO2 value.

267
User preferences

42.1.4 Interface tab Chinese


The interface tab sets the user interface Ukrainian
preferences for features available in a ventilatory Swedish.
mode. Note: Only for the Chinese language when
selected a new feature becomes available.
The new feature is to disable “Continue
without flow sensor” button for the “Flow
sensor not connected” alarm condition.

Date Format - dd/mm/yyyy or mm/dd/yyyy


(Default dd/mm/yyyy)
Pressure - mbar or cmH2O (Default mbar)
CO2 Units - % Volume, kPa or mmHg.

42.1.6 Save / Quit tab


The Save / Quit tab allows the user to save or
discard change to the user preferences.

Monitored values panel Single column or Double


column (Default Single column )
Graph background - OFF or ON (Default OFF)
Waveforms - Lines or filled in (Default lines)

42.1.5 Regional tab


The interface tab sets the user interface
preferences for features available in a ventilatory
mode.

The user is presented with three options.


Save
Factory reset values
Exit
Pressing Save will record the changes to system
memory. Press OK to return to the main menu.

Pressing Factory reset values will reset the


ventilator to factory defaults but not record the
changes to system memory. The user should press
either the OK or SAVE button to record the changes
Language - English (Default English) to system memory.
Available languages:
Pressing EXIT will end the user preference
French session. The user will have to press and hold the
Spanish power button for 15 seconds to cycle the power.
German Caution. Pressing the exit button without
Italian saving will discard all changes made in this
Dutch session. The user will have no option but to
Polish cycle power and repeat the process.
Russian
Portuguese
Turkish
Japanese
Greek

268
Event and patient log software

Event and patient log software

269
Event and patient log software

43. SLE 6000 Event and Patient 43.2 Installation of software


Log viewer software Insert the SLE USB memory stick supplied with the
ventilator into the host computer.
Caution: SLE 6000 Event and patient log
software is intended for research purposes When the AutoPlay window appears select "Open
only. SLE 6000 Event and patient log software folder to view files.
must not be used for clinical purposes
including diagnosis or patient monitoring.

Caution: Ensure exported ventilation data is


protected in accordance with local laws and
regulations. Refer to institutional controls
and processes to store, safeguard and
protect the exported ventilation data and files.
Open the folder Setup Wizard.
43.1 Minimum system requirements Select the file “SetupLogViewer.msi”.
Operating system ... Windows 7 Right click the set up wizard “SetupLogViewer.msi”
CPU........................ Pentium or compatible, and select “Install”.
300MHz Set up wizard for Log Viewer opens. Press “Next” in
Memory .................. 128 MB the set up wizard
Press “Next” in Select Installation folder dialogue
Hard drive............... 2 GB
Press “Next” in the Confirm Installation dialogue
Media ..................... CD-ROM drive or USB port
Close the installer
Display ................... Super VGA (800 × 600)
A shortcut “Log Viewer” is automatically installed in
Input device(s)........ Keyboard, mouse user’s desktop.
.Net Framework...... version 3.5 43.3 Downloading the Patient log or
Event log
43.1.1 Memory stick requirements
Type ....................... USB2 The process for downloading the log files is the
same for Patient or Event log.
Size ........................ Minimum 1Gb
The Patient log process is shown below.
Turn on the ventilator and allow it to enter Standby
mode.

Insert a USB memory


stick into the data port
at the rear of the
ventilator.

270
Event and patient log software

Activate the Utilities tabs (1) and select the Data tab 43.4 Export file formats
(2).
The SLE6000 creates a folder with a identification
2 number that is unique that ventilator.
 Example: Ventilator ID 1001453795
Within the folder the user will find a number of files.
Each file is prefixed with the date followed by serial
code and then file type.
 Example: 16_03_31_192222_RealtimeLog.dat

1 The patient log generates 3 files:


1. 16_03_31_192222_Realtimelog.dat
Select the Patient Log button 2. 16_03_31_192225_AlarmsLog.txt
3. 16_03_31_192335_TrendsDataLog.dat
Patient Log The event log generates 2 files:
1. 16_03_31_192345_SystemLog.evt
2. 16_03_31_192225_DebugLog.evt
Note: The ventilator does not overwrite any
existing files but creates new files with a
different serial code.
The ventilator will check the USB memory
On selection of the Patient log button the “Start
stick for enough free space for the new export
Export” button becomes active. Press the button to
files. If not enough free space is available the
start the export to the USB memory stick.
ventilator will display the following message
Patient Log “The USB stick does not have enough free
space. Minimum XMB free space needed”.

Note: If the user also exports the screen


Start export captures these will be located within the same
folder.
File name:
The ventilator will display a progress bar during the 16_04_01_193759_ScreenCapture_01.bmp
export process. Also displayed is a cancel button
that allows the user to terminate the export process. 43.4.1 File types
The ventilator creates three file types, .dat .evt and
.txt. The .dat and .evt files can only be read by the
supplied viewer software. the .txt file can be read by
most desk top publishing or spreadsheet programs.
43.4.1.1 RealtimeLog
File type: 16_03_31_192222_RealtimeLog.dat
Patient Log
The RealtimeLog captures the real time waveform
data for pressure, flow, volume and CO2 (CO2 not
implemented in this release of software).
43.4.1.2 AlarmsLog
Start export File type: 16_03_31_192225_AlarmsLog.txt
The AlarmsLog captures all alarm conditions.
Cancel

When complete the ventilator will indicate that the


data export was OK.
Remove the USB memory stick from the ventilator.

271
Event and patient log software

43.4.1.3 TrendsDataLog
File type:16_03_31_192335_TrendsDataLog.dat
The TrendsDataLcontains the following trend data
1) PIP
2) PEEP
3) MAP
4) CPAP
5) DeltaP
6) Vte
7) Vte Spont
8) Vmin
9) %VminSpont
10) RR
11) RR Spont
12) Triggers
13) CO2
14) SpO2
15) Resistance
16) Compliance
17) DCO2
18) Pulse Rate
19) SIQ
20) Reference O2
21) Set FiO2
22) Current measured O2

43.4.1.4 SystemLog
File type:16_03_31_192345_SystemLog.evt
The SystemLog captures all the user interaction
with the ventilator.
Including the SpO2 target range.
43.4.1.5 DebugLog
File type:16_03_31_192225_DebugLog.evt
The DebugLog captures all the software messages.
This feature is for service personnel only.
43.4.1.6 Log records
Each log can stores 64,000 records apart from the
AlarmsLog which is limited to 1000. When any log
becomes full the oldest log entry is deleted and all
current log entries move down to make room for the
new log entry.

272
Event and patient log software

43.5 Log Viewer Features

43.5.1 Load Files Date time ticks will be marked for Alarms, Events
This button is used to load the and Trends in solid blue colour
events log (“SystemLog.evt”),
alarms log(“AlarmsLog.txt”) and 43.5.2 Export to XML
Trends log (“TrendsDataLog.dat”). This feature saves the Alarms
and Event as a XML file.
Press “Load files” button, and select files to be
opened. To select multiple files, press “Ctrl” button Press “Export to XML” button.
in the keyboard and select all three files Give a filename and save as
(SystemLog.evt, AlarmsLog.txt and (.*xml)
TrendsDataLog.dat) to be opened.
43.5.3 Export to Excel
Within around 30 - 60secs events and alarms will be
loaded and displayed in the “Alarm Event window” 43.5.3.1 Events Log / Trends Log
(window in the left side of the application). Press either the "Events Log"
or "Trends Log" button to save
the data as an Excel file.

Note: To change the second column in excel


sheet to display correct date time, you will
need to change the default format of the excel
column.
Perform the following steps in exported excel.
Choose whole of second column
“EventTime” (click a cell in second column
press Ctrl+ space bar)
Right click select “Format Cells”.
Choose “Custom”and type in as “dd/mm/yyyy
hh:mm:ss.000” in the “Type” field of excel
sheet, and press “OK”.

Also the start time, end time and date time ticks will
be marked in the Timeline (which is at the very
bottom of the application).

273
Event and patient log software

43.5.4 Search Filter Waveform play can be stopped at any time by


This feature is to pressing the icon “l l”
search entries in Alarm Waveforms can be scrolled to the desired date-time
Event window. by adjusting the “Position” scroll bar.
Waveform screen can be hidden by pressing the
Type (for e.g.: “PIP”) in Search filter textbox. Press “Hide Trend” button at the top right corner
“Search items” button. “Hide Trend” button will only be available when the
All entries with text “PIP” will be displayed in Alarm trend waveforms are shown.
Event window
43.5.6.2 Trend Data button
If after viewing trends and returning to the data view,
43.5.5 Load Trend data by day
this button will re-display the trend data in its
Log Viewer numerical table if it not visible.
application is
ready to read 43.5.7 All Trends
and display “All Trends” button in Trend Settings panel loads
the Trend data, once the date time ticks are marked upto14 days trends and export to excel in one
in the Timeline for Trends. button click (thus removing the manual process of
Choose any day by pressing the “Read Trend data” selecting each day of trend, loading the data and
drop down box (for e.g.: Day 14). Or type manually then exporting to excel.
the day as “Day 14”
Caution: All Trends export can take a very
Wait around 60s (might take little longer depending
long time from few seconds to 30 minutes or
on the size of loaded data. Trend data is logged
more (depending on how long the ventilator
every second for the whole day. When the wait
was running)
cursor turns to default mouse cursor, “Trends / Real-
time window” will be opened in right side of the
application with Trends data for the chosen day 43.5.8 Load Real-time Data
(e.g.: Day 14). 43.5.8.1 Wave Data
To open another day of trend data, repeat the above The Wave Data button
steps. will load the real-time
wave date using a 30
43.5.6 Trends Settings second sampling rate.
43.5.6.1 Trends button 43.5.8.2 Entire Waves
Press “Trends” The Wave Data button will load the real-time wave
button in the “Trend date using a 50 millisecond sampling rate.
Settings” panel.
Caution: An Entire waves load will take
approximately 10 minutes.
Trends edit panel will be displayed; where up to 6
trend parameters can be selected by pressing drop- 43.5.8.3 Waves
down box. Waves edit panel will be displayed; where up to 6
Default parameters: waveforms can be selected by pressing drop-down
Display 1: O2 box.
Default parameters:
Display 2: MAP
Display 1: Pressure wave
Display 3: Vmin
Display 2: Flow wave
Display 4: SpO2
Display 3: Volume wave
Display 5: PEEP
Display 4: EtCO2 wave
Display 6: PIP
Display 5: SpO2 wave
Press “OK” button in the Trends edit panel. It might
take few seconds to display the Trends waveform Display 6: Off
Pressing the play icon “►” in the menu bar, plays Press “OK” button in the Wave edit panel.
the trends waveform.
Pressing the play icon “►” in the menu bar, plays
The speed of the trend waveform can be adjusted the trends waveform.
by scrolling the “Playback Speed” scroll bar in the
menu.

274
Event and patient log software

The speed of the trend waveform can be adjusted


by scrolling the “Playback Speed” scroll bar in the
menu.

43.5.9 “UTAS” option


This is a password protected feature not
for general use.

43.5.10 Timeline

At the bottom of the application, there is a bar


showing the Start time and End time of the exported
data (which is 14 days of data).
There are two vertical lines in the timeline (called
left cursor and right cursor)
Alarms, Events and Trends data will be shown in
solid blue colour in the timeline, so the user can
drag these cursors to the blue coloured region. And
Alarms and Events (and trends if loaded) will be
automatically updated based on the left and right
cursor positions.
First time, click on the left cursor and drag the
cursor.

43.5.11 Display data from last day


Press this button in Time line to display events,
alarms and trends in the last day (14th day).

275
Event and patient log software

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276
Training

44. Training (User) 45. Training (service)


SLE provide user training courses for the SLE6000 SLE provide service training courses for the
infant ventilator. SLE6000 infant ventilator.

End-User Training The courses cover the servicing and maintenance


SLE, or their Distributor, offers clinical support to all of hardware and software of the SLE6000 infant
users of SLE ventilators. This is always coordinated ventilator.
through the local Sales Specialist or Distributor to
ensure effective use of your time. Over the course Please contact SLE Ltd.
of the ventilator installation, a specialist will ensure
that users receive in-depth training on SLE Please ask for “Service training”
products.
Telephone: +44 (0)20 8681 1414
On-Going Training Fax: +44 (0)20 8649 8570
Once the ventilator has been installed and
commissioned, SLE or your local Distributor’s E-mail: service@sle.co.uk
clinical support staff, will spend time in the NICU,
with the medical and nursing staff, to answer any
questions that may arise and offer further support.

Specialist in vivo Workshops


SLE supports clinician-led ventilation seminars; the
seminars are aimed at consultant level
Neonatologists and Paediatric Intensivists.

In some countries SLE will sponsor a clinical expert


to present a seminar using a prepared animal lung
to demonstrate lung recruitment. This is usually
aimed at Registrars, House Officers and senior
nursing staff.

Additionally, SLE runs a series of in vivo ventilation


workshops around the world each year. These
courses are intended for clinicians and focuses on
lung protective strategies. Using an in vivo model,
these seminars are hands-on and include both
conventional and high-frequency oscillation
ventilation.

Please contact SLE Ltd.

Please ask for “End user training”

Telephone: +44 (0)20 8681 1414


Fax: +44 (0)20 8649 8570

E-mail: sales@sle.co.uk

277
Training

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278
Accessories

Consumables & Accessories

279
Accessories

46. Consumables & Accessories

Consumable Items Image Part No

10mm Patient Circuit (Single use).


BC6188/15
Box of 15

10mm Patient Circuit (Single use) Dual Heated Wire with


BC6188/DHW/07
chamber. Box of 7

10mm Patient Circuit (Single use) Dual Heated Wire without


BC6288/DHW/15
chamber. Box of 15

Nitric oxide adaptor kit (Single use) for use with BC prefix patient
BC6110/KIT/5
circuit.

Dual Exhaust Hose Assembly for nitric oxide scavenging N4110/10

Flow sensor (autoclavable). N5402-REV2

Flow sensor (Sterile Single use).


N5302/05
Pack of 5

Flow sensor (Sterile Single use).


N5302/50
Pack of 50

Silencer (Single use)


N2186/SU/20
Pack of 20

Silencer (Single use)


N2186/SU/50
Pack of 50

280
Accessories

Warning. Use of cables other than those listed


below may result in increased
electromagnetic emissions or decreased
electromagnetic immunity

Accessories Image Part No

SLE6000 Core Configuration Software Module Z6000/COR

SLE6000 HFOV (including HFOV VTV) Software Module Z6000/HFO

SLE6000 Single Limb NIV Software Module Z6000/SLN

SLE6000 Oxygen Therapy Software Module Z6000/O2T

SLE6000 VTV (Conventional Ventilation) Software Module Z6000/VTV

SLE6000 ETCO2 Monitoring Software Module Z6000/ETC

SLE6000 Masimo SpO2 Monitoring Software Module Z6000/SPO

SLE6000 NIPPV Tr. Software Module Z6000/NIP

SLE6000 OxyGenie® O2 Closed Loop Software Module Z6000/CLP

Flow Sensor connecting cable with anti microbial coating.


N6656
(1.5 m)

SLE uSpO2 cable (Masimo SET) (Cable 1.8 m) and LNCS


L6000/SP2/KIT
sensor sample pack kit

MicroPod™ Microstream™ etCO2 module LETC2/RS03000

MicroPod™ Mounting Kit (Vesa) LETC2/9279

MicroPod™ Mounting Kit (Clip) LETC2/9283

MicroPod™ Calibration Software Kit


LETC2/9348
(LEMO connection cable 1 m)

Mains cable (1. 5m) UK 3 pin plug & 90º IEC connector M0255/095

Mains cable (1.5 m) Shuko (European) plug & 90º IEC


M0255/096
connector

Mains cable (1.5 m) Nema North American) plug & 90º IEC
M0255/097
connector

RS232 cable (2 m) L6000/232/001

VGA video cable (Male to Male) 2m L6000/VGA/001

Nurse call cable (3 m fully wired) L6000/NCW/001

Nurse call cable (3 m normally open) L6000/NCO/001

Nurse call cable (3 m normally closed) L6000/NCC/001

DC input cable (2 m) L6000/0DC/001

281
Accessories

Accessories Image Part No

Spare exhalation Block. N6622

Silencer (Reusable) N2186/RS

Oxygen water trap assembly L6000/XWT

Fully automatic water trap bowl. N9606/01

O2 hose, 3 metres length - 90º NIST nut to BS probe.


N2035/RAC/001
Tube colour white.

Air hose, 3 metres length - 90º NIST nut to BS probe.


N2199/RAC/001
Tube colour black.

O2 hose, 3metres length - 90º DISS Male to DISS Female.


N2035/RDS/001
Tube colour White

282
Accessories

Accessories Image Part No

Air hose, 3 metres length - 90º DISS Female to DISS Male.


N2199/RDS/001
Tube colour Black

O2 hose, 4.3 metres length - 90º DISS Male to DISS female.


N2035/RAD/GRN
Tube colour Green

Air hose, 4.3 metres length - 90º DISS Female to DISS Female.
N2199/RAD/YEL
Tube colour Yellow

MR850 Humidifier Heater Base. (230V) For UK Only.


N3850/00

MR850 Humidifier Heater Base. (230V)


N3850/01

Heater adaptor for use with Single Use patient circuits &
chambers and MR850 Humidifier Heater Base. N5600

Dual Heater adaptor for use with Single Use patient circuits &
chambers and MR850 Humidifier Heater Base. N5601

MR858 Heater adaptor for use with Re-usable patient circuits &
chambers and MR850 Humidifier Heater Base. N3858

MR860 Dual Temperature Probe (for 850 F&P humidifier).


N3860

283
Accessories

Accessories Image Part No

Test Lung. N6647

Medicart with two locking castors, basket, hose hook and medi
N6690
rails.

Aerogen Solo USB controller Starter Kit - UK L1025/SLU/0UK

Aerogen Solo USB controller Starter Kit - Northern Europe L1025/SLU/0NE

Aerogen Solo USB controller Starter Kit - Central Europe L1025/SLU/0CE

Aerogen Solo USB controller Starter Kit - East Europe L1025/SLU/0EE

Aerogen Solo USB controller Starter Kit - Southern Europe L1025/SLU/0SE

Aerogen Solo USB controller Starter Kit - Scandinavia L1025/SLU/0SC

Aerogen Solo USB controller Starter Kit - Russia & Baltics L1025/SLU/0RB

Patient Circuit Arm. N6627/212

Instructions for use for SLE6000. (English) UM165/UK

Instructions for use for SLE6000. (French) UM165/FR

Instructions for use for SLE6000. (Spanish) UM165/ES

Instructions for use for SLE6000. (German) UM165/DE

Instructions for use for SLE6000. (Italian) UM165/IT

Instructions for use for SLE6000. (Turkish) UM165/TR

Instructions for use for SLE6000. (Polish) UM165/PL

Instructions for use for SLE6000. (Portuguese) UM165/PT

Instructions for use for SLE6000. (Dutch) UM165/NL

Instructions for use for SLE6000. (Russian) UM165/RU

Instructions for use for SLE6000. (Ukrainian) UM165/UA

Instructions for use for SLE6000. (Greek) UM165/GR

Instructions for use for SLE6000. (Swedish) UM165/SE

Instructions for use for SLE6000. (Chinese) UM165/CN

Instructions for use for SLE6000. (Japanese) UM165/JP

Service Manual for SLE6000 (English Only) SM38

284
Glossary

47. Glossary High frequency oscillatory


HFOV
ventilation
(American Standard Code for
HFNC High flow nasal cannulae
Information Interchange) is the most
common format for text files in Hz Hertz (Cycles per second)
ASCII
computers. Not suitable for non-
English letters but suitable for I:E Inspiratory: Expiratory Ratio
numerics.
Insp Time Inspiratory Time
O2 Oxygen
ISM Industrial, scientific, and medical
°C Degrees Celsius
kg Kilogram
°F Degrees Fahrenheit
kHz Kilohertz
» Approximately equal to
LED Light Emitting Diode
bar Unit of Barometric Pressure
LF Low Frequency
BPM Breaths Per Minute
l/min Litre per Minute
Body temperature and pressure
BTPS mbar Millibar
staturated
MHz Megahertz
Ratio of the compliance during the
C20/C last 20% of the respiratory cycle MMS Messaging Management System
compared to whole cycle
ml Milliliters
cm Centimetre
ms Millisecond
cmH2O Centimetres of water
Mean P Mean Pressure
CMV Continuous Mandatory Ventilation
NEEP Negative End Expiratory Pressure
Compl.
Compliance nasal intermittent Positive Pressure
or C NIPPV
Ventilation
Continuous Positive Airway Nasal Continuous Positive Airway
CPAP NCPAP
Pressure Pressure
CPU Central processing unit NHFO Nasal High Frequency Oscillation
Gas transport coefficient, based on MAP Mean airway pressure
DCO2
tidal volume and frequency.
MO Monitor output
DHW Dual heated wire
O2% Percentage Oxygen
dP Delta Pressure
PCLC Physiological closed loop controller
DPI Dots per inch
PEEP Positive End Expiratory Pressure
EMC Electromagnetic Compatibility
PIP Peak Inspiratory Pressure
ES External Sensor
POST Power on self test
ESMO External Sensor & Monitor
PPM Planned preventative maintenance
ET Endotracheal
PR Pulse Rate
EtCO2 End-tidal CO2
psi Pounds per Square Inch
GHz Gigahertz
PSU Power Supply Unit
Global Medical Device
GMDN PTV Patient Triggered Ventilation
Nomeclature.
RF Radio Frequency

285
Glossary

RR Respiratory Rate

Resist.
Resistance
or R

RS232 is a long established


standard for low speed serial data
RS232C
communication, “C” being the
current version.

SaO2 Saturated arterial oxygen

Synchronised Intermittent
SIMV
Mandatory Ventilation

SIQ Signal Identification and Quality

Peripheral capillary oxygen


SpO2
saturation

Standard temperature and pressure


STPD
dry.

Ti Inspiratory time

VTV Volume Targeted Ventilation

tcPCO2 Transcutaneous Carbon Dioxide

tcPO2 Transcutaneous Oxygen

UI User interface

USB Universal Serial Bus

VLBW Very low birth weight

VGA Video Graphics Array

Vol. Cont. Volume Control

Vexp(ml) Expired Volume Control in millilitres

Vinsp(ml). Inspired Volume in millililtres

Vmin (l) Minute Volume in litres

Vt Tidal volume

Vte Tidal Volume expiratory

286
Marking and symbols

48. SLE6000 markings and


symbols
48.1 Description of ventilator markings
USB port

General Warning Symbol

Symbol for Equipotentiality

Caution Symbol

Direct Current icon

Warning, Electricity

Device weight

Refer to Instruction Manual/Booklet

On/Off

Type BF Applied Part Symbol


CE mark and notified body
number

Nurse Symbol

Serial number

Ethernet port

Manufacturer

VGA port

Date of manufacture

Dispaly port

WEEE Symbol

287
Marking and symbols

48.2 Description of option markings 48.3 Description of interface markings.


.Located on side of ventilator

Warning Symbol
Core software specification and
version number software option.

Mains power icon


HFO ventilation software option.
HFOV, HFOV+CMV & nHFOV

Direct Current icon

Volume Targeted Ventilation


software option.

Battery icon 100%

Non invasive software option.


nCPAP & DuoPAP

Battery icon 0%

Non invasive software option.


NIPPV Tr.
Fuse Symbol

Masimo SpO2 monitoring


software option.
Audio paused

Microstream™ etCO2
monitoring software option. Alarm inhibit

Upper alarm limit

288
Marking and symbols

Lower alarm limit Scroll right (Cursor)

Screen capture Scroll left (Scroll)

Backspace Scroll right (Scroll)

Close HFO in expiration phase only.

HFO in inspiration and


Scroll up
expiration phase.

Scroll down Locked screen

Zoom in (Zoom)
Play

Zoom out (Zoom) Pause

Scroll left (Cursor) Confirm

289
Marking and symbols

48.4 Description of Micropod™


markings.

Caution

Type BF Defibrillator proof


protection

Gas inlet

Gas outlet

For prescription use only

CE mark

WEEE Symbol

290
SLE reserves the right to make changes without
prior notice in equipment, publications and prices as
may be deemed necessary or desirable.

Revision History

Rev. Date Change ref.

1 30/04/18 Initial issue.

2 18/07/18 CR1709

3 16/11/18 CN 101
CR 1746
CR 1800
CR 1801
CR 1802
CR 1824
CR 1858

4 21/11/18 CR 1889

5 14/03/19 CR 1918 Mantis 1768


CR 1951 Mantis 1978
CR 1952 Mantis 2185
CR 1962 Mantis 2203
CR 2316 Mantis 2345
Mantis 2361

6 26/03/19 CR 2368

7 11/06/19 CR 2148

8 08/07/19 CN 139
CR 2428

9 08/11/19 CN 160

10 31/01/20 CN 176

11 19/05/20 CN 181
CR 2788
CR 2806

12 02/07/20 CR 2854
CR 2926
V2.0.98

291
+44 (0)20 8681 1414 SLE Limited

Twin Bridges Business Park


+44 (0)20 8649 8570
232 Selsdon Road

sales@sle.co.uk South Croydon

Surrey
www.sle.co.uk
CR2 6PL

UK

When the smallest thing matters

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