UM165-UK Issue 12 (SLE6000 User Manual)
UM165-UK Issue 12 (SLE6000 User Manual)
Distributor
2
Fast index
Patient circuit selection for invasive ventilation and modification for non invasive ventilation 50
Ventilator setup Non invasive ventilation - High flow nasal cannula therapy 94
CPAP 66
CMV 68
PTV 70
PSV 72
SIMV 74
HFOV 76
HFOV+CMV 78
nCPAP 82
NIPPV 84
NIPPV Tr. 86
nHFOV 88
NCPAP 90
DuoPAP 92
O2 therapy 94
Technical information
OxyGenie® 110
Troubleshooting 244
3
Fast index
4
Contents
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
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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
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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
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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
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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
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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
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Contents
12
Introduction
Introduction
13
Introduction
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
15
Introduction
16
Introduction
17
Introduction
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
19
Introduction
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
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
21
Introduction
22
Intended use
Intended use
“Summary statement” on page 24
“Condition of use” on page 24
23
Intended use
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.
24
Warnings and cautions
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
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.
28
Warnings and cautions
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
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
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
36
Ventilator layout
Ventilator layout
37
Ventilator layout
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
39
Ventilator layout
31
32
33
36 34
35
40
Ventilator setup
Ventilator setup
41
Ventilator setup
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).
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.
42
Ventilator setup
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
44
Ventilator setup
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.
Press and hold the power button for 2
seconds.
47
Ventilator setup
48
Patient circuits
49
Patient circuits
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
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.
Airway”.
M
L
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
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
53
Patient circuits
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.
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
6 Connect the exhalation limb (J) to the bacterial
filter fitted to the exhalation port (K) marked
“Exhalation port from Patient”.
H Q
Q
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.
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
B
D
C
E
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.
D
A
B
G
F
Please refer to the consumable catalogue or the
SLE website for part numbers.
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
L
K
H
J
13.5.3 Fitting the temperature probes
8 Connect the humidifier temperature probes to
ports (M & N).
N
M
O
59
Patient circuits
O
P
Q
R
60
Patient circuits
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
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
H
K
J
M
H N
62
Patient circuits
O
P
R
Q
R
H
G
63
Patient circuits
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
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%.
Ti CPAP PIP O2
Manual
Breath
Auto O2
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.
Seconds
Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.
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
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%.
Seconds l/min
Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.
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.
l/min %
Seconds
Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.
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.
Auto O2
Interactive controls
The PEEP control cannot be
increased beyond the set PIP. The
PIP cannot be decreased below the
set PEEP.
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
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
Auto O2
78
Ventilation - Invasive
HFOV+CMV
default alarm
thresholds
O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)
60
21
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
VTV control
Alarm thresholds
Tidal volume (Vte) ...........High and low
Minute volume (Vmin) .....High and low
Leak (%) ..........................Maximum
80
Ventilation - Non invasive
Ventilation - Non-invasive
“Non-invasive - Dual limb”
“nCPAP D” on page 82
“NIPPV D” on page 84
“nHFOV” on page 88
“DuoPAP” on page 92
81
Ventilation - Non invasive
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%.
BPM Seconds %
Ti CPAP PIP O2
Manual
Breath
Auto O2
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”
83
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.
Seconds
84
Ventilation - Non invasive
NIPPV D
default alarm
thresholds
O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)
60
21
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)
85
Ventilation - Non invasive
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%.
Seconds mbar %
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”
87
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
88
Ventilation - Non invasive
nHFOV
default alarm
thresholds
O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)
60
21
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.
89
Ventilation - Non invasive
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%.
BPM Seconds %
Ti CPAP PIP O2
Manual
Breath
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”
91
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.
Seconds mbar %
Auto O2
92
Ventilation - Non invasive
DuoPAP
default alarm
thresholds
O2 %
Set maximum
threshold.
(Thresholds
invisible)
Alarm name:
O2 over set limit.
O2
(%)
60
21
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
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
96
SpO2 & etCO2 Sensors
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
R = S(660)/S(905)
98
SpO2 & etCO2 Sensors
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
100
SpO2 & etCO2 Sensors
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.
101
SpO2 & etCO2 Sensors
102
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. Pleth/SIQ waveform
Shows the Pleth waveform (Upper trace) and the
signal quality indicator (SIQ) (Lower trace).
3. SpO2 trend.
103
SpO2 & etCO2 Sensors
104
SpO2 & etCO2 Sensors
105
SpO2 & etCO2 Sensors
etCO2
106
SpO2 & etCO2 Sensors
107
SpO2 & etCO2 Sensors
108
OxyGenie®
OxyGenie®
109
OxyGenie®
110
OxyGenie®
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”
111
OxyGenie®
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.
112
OxyGenie®
113
OxyGenie®
114
Operational features
Operational features
115
Operational features
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
118
Operational features
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%.
119
Operational features
%
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
120
Operational features
Diagram B
Diagram A
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).
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
MAX
Delta P
or
MAX PIP
124
Operational features
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
126
User interface - Standby mode
127
User interface - Standby mode
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
129
User interface - Standby mode
130
User interface - Standby mode
131
User interface - Standby mode
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
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.
132
User interface - Standby mode
133
User interface - Standby mode
1
Screen captures
134
User interface - Standby mode
W X Y
135
User interface - 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).
136
User interface - Standby mode
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
138
User interface - Standby mode
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
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
139
User interface - Ventilation mode
140
User interface - Ventilation mode
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
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User interface - Ventilation mode
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
144
User interface - Ventilation mode
145
User interface - Ventilation mode
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
148
Technical data
149
Technical data
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.
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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).
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Technical data
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.
N5302 N5402-REV2
Warning: Do not use the N5302 flow sensor if
its packaging has been damaged.
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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.
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
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Technical data
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
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Technical data
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
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%
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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
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"
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"
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Technical data
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"
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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
O2 concentration: . . 21 to 100%
Resolution: . . . . . . . . 1%
Factory set default:. . 21%
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Technical data
O2 concentration: . . 21 to 100%
Resolution: . . . . . . . . 1%
Factory set default:. . 21%
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Technical data
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
160
Technical data
161
Technical data
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%)
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Technical data
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
Limits tab
Tab allows access to alarm limits.
Limits Alarm limits only active when
ventilating.
Single press to select
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Technical data
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
Term Sens
Term Sens (Termination
sensitivity) control
Range 5 - 50 %
Single press to select or cancel
%
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
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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
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Technical data
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:
167
Technical data
168
Technical data
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
26.15 IP rating
Type of protection against ingress of water: IP21
Ambient Temperature:
-20°C to +50°C
Relative Humidity: . . . 10% to 90% non-condensing
Atmospheric Pressure:
500 mbar to 1060 mbar
169
Technical data
170
Technical data
171
Technical data
172
Technical data
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)
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Technical data
3 A new oxygen cell is required. 68 User interface has reset. Confirm settings.
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
175
Technical data
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.
176
Technical data
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
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.
178
Technical data
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
180
Technical data
181
Technical data
3 A new oxygen cell is required. 68 User interface has reset. Confirm settings.
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
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
30 Trig (eg in CPAP) SpAWRR (Spontaneous Airway Respiration Rate) Measurement -1 Yes
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
40 Set HFO delta P sHFVAm (set high frequency ventilaton amp) Setting 0 No
44 Set flow sfgFl (Setting: total fresh gas flow on the mixer) Setting 0 No
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
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
27.4.5 Waveform
188
Technical data
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.
27.6 Ethernet
The ethernet port is non-functional in this release of
software.
189
Technical data
190
Technical data
191
Technical data
192
Technical data
kPa
193
Technical data
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)
194
Technical data
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
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
197
Technical data
198
Technical data
199
Technical data
200
Technical data
201
Technical data
202
Technical data
203
Technical data
204
Technical data
205
Technical data
206
Technical data
207
Technical data
208
Technical data
209
Technical data
210
Technical data
211
Technical data
212
Technical data
213
Technical data
214
Technical data
215
Technical data
216
Technical data
217
Technical data
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
X
X
X
X
X
are not of the correct type
X
X
X
X
X
X
X
X
X
X
X
X
X
X
are under 14.6V.
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
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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
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
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
are under 14.6V.
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
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
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
X
X
X
X
table
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
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
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
30.5 “Ventilator out of calibration” fault
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
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
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
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Oxygen 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
X
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
222
Technical data
223
Technical data
224
Technical data
225
Technical data
226
Technical data
227
Technical data
228
Technical data
229
Technical data
230
Technical data
231
Technical data
232
Technical data
233
Technical data
234
Technical data
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.
235
Technical data
may be sticking the balls in place.
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).
236
Technical data
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
237
Technical data
238
Technical data
239
Technical data
240
Technical data
241
Technical data
Subsystems
242
Troubleshooting
Troubleshooting
243
Troubleshooting
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: 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.
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
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.
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
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.
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.
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
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.
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
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.
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.
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
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.
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.
249
Troubleshooting
250
PPM & Functional testing
251
PPM & Functional testing
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
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.
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
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.
255
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”.
256
PPM & Functional testing
257
PPM & Functional testing
258
Installation instructions
Installation instructions
“Unpacking.” on page 260
259
Installation instructions
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.
260
Installation instructions
3. Remove the ventilator carton by using the lifting 41.2 Medicart assembly
handles.
41.2.1 Medicart kit contents
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
from points D and E. A
4. Remove the Medicart carton from the base of the
box.
F
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
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
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
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” .
263
Installation instructions
C
A
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
266
User preferences
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.
267
User preferences
268
Event and patient log software
269
Event and patient log software
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
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
43.5.1 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.
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
274
Event and patient log software
43.5.10 Timeline
275
Event and patient log software
276
Training
E-mail: sales@sle.co.uk
277
Training
278
Accessories
279
Accessories
Nitric oxide adaptor kit (Single use) for use with BC prefix patient
BC6110/KIT/5
circuit.
280
Accessories
Mains cable (1. 5m) UK 3 pin plug & 90º IEC connector M0255/095
Mains cable (1.5 m) Nema North American) plug & 90º IEC
M0255/097
connector
281
Accessories
282
Accessories
Air hose, 4.3 metres length - 90º DISS Female to DISS Female.
N2199/RAD/YEL
Tube colour Yellow
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
283
Accessories
Medicart with two locking castors, basket, hose hook and medi
N6690
rails.
Aerogen Solo USB controller Starter Kit - Russia & Baltics L1025/SLU/0RB
284
Glossary
285
Glossary
RR Respiratory Rate
Resist.
Resistance
or R
Synchronised Intermittent
SIMV
Mandatory Ventilation
Ti Inspiratory time
UI User interface
Vt Tidal volume
286
Marking and symbols
Caution Symbol
Warning, Electricity
Device weight
On/Off
Nurse Symbol
Serial number
Ethernet port
Manufacturer
VGA port
Date of manufacture
Dispaly port
WEEE Symbol
287
Marking and symbols
Warning Symbol
Core software specification and
version number software option.
Battery icon 0%
Microstream™ etCO2
monitoring software option. Alarm inhibit
288
Marking and symbols
Zoom in (Zoom)
Play
289
Marking and symbols
Caution
Gas inlet
Gas outlet
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
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
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
Surrey
www.sle.co.uk
CR2 6PL
UK