Page 2 All rights reserved. No part of this publication may be reproduced, stored in any retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopy, recording or otherwise, without prior permission of SLE. © Copyright SLE 10/04/2006. Manual : UM0083 Issue 6 SLE Part Nº:...
Page 3 SLE5000/SLE4000 Infant Ventilator The warnings on pages 28 to 32 must be read and understood before using the SLE5000/SLE4000 ventilator. Failure to do so could lead to injury or death of the patient. MAKE SURE THAT THE VENTILATOR BACK-UP POWER SUPPLY IS FULLY CHARGED: Page 134.
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Page 5: Table Of Contents
2.4.1. PSV with TTV ....................20 2.5. SIMV (Synchronized Intermittent Mandatory Ventilation).........21 2.5.1. SIMV with PSV ..................22 2.5.2. SIMV with TTV...................23 2.6. HFO (SLE5000 only) ..................23 2.7. HFO+CMV (SLE5000 only) ................23 2.8. Mode controls ....................24 2.8.1. TTV Control Mode ..................24 2.9. Technical Description ..................25 3.
Page 6 7.8.5. Set Trigger for CPAP, PSV, PTV & SIMV ..........57 7.8.6. Pressure Support in PSV ................57 7.8.7. Pressure Support in SIMV................. 58 7.8.8. HFO Activity (SLE5000 Only)..............58 7.9. Alarm Panel ..................... 59 7.10. Default Waveform Windows................60 7.11.
Page 7 11.1.1. Complete Power Fail Alarm Test.............95 11.1.2. Setting FiO .....................96 11.1.3. Functional Testing with No Flow Sensor ..........96 11.1.4. Calibration of the Flow sensor ..............96 11.1.5. Oxygen Alarm Test ..................98 11.1.6. Function and Alarm Testing..............100 11.1.7. High Pressure Alarm................104 11.1.8.
Page 8 14.2.5. HFO Only Ventilator Set Threshold Alarms (SLE5000 only)....142 14.2.6. Patient Leak Alarm .................. 143 14.2.7. Reset Contamination Alarm ..............143 14.3. Patient Circuits, Humidification and Nitric Oxide Therapy ......144 14.3.1. Patient Circuits with Incubators, Cots and Paediatric beds..... 144 14.3.2.
Page 9 19.0.3. Breath Not Detected ................194 19.0.4. Low Tidal Volume ..................194 19.0.5. Unexpected Rise or drop in Mean P (SLE5000 only) ......195 19.0.6. Unexpected Rise or Drop in Max P (SLE5000 only)........195 19.0.7. Unexpected Rise or Drop in Min P (SLE5000 only).........195 19.0.8.
Page 10 26. Patient Circuits ....................... 247 26.1. Warnings for Patient Circuit Use..............247 26.2. 10mm Diameter Re-usable Patient Circuit (SLE Part Nº N2391/50) ..... 248 26.2.1. Sterilising of the N2391/50 re-usable Patient Circuit....... 248 26.3. 10mm Patient Circuit, SLE Part Nº N5188 & N5188/850......250 26.4.
Page 11 28.8. Power, Dimensions, Standards etc..............272 28.9. Environmental Storage Conditions ..............272 29. Pneumatic Unit Schematic ..................273 30. Ventilator Labelling ....................274 30.1. SLE4000......................274 30.2. SLE5000......................275 31. Consumables and Accessories ................278 32. Glossary of Abbreviations Used in this Manual ..........284 33. Index .........................287 Page 11 of 292...
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Page 13 Introduction Page 13 of 292...
Page 14: Introduction
SLE4000 and SLE5000 ventilator is that the SLE5000 has two extra modes of operation, these being HFO and HFO+CMV. The user manual will from this point onwards refer to the SLE4000 and SLE5000 as “the ventilator”. Where the user manual details an operation or mode: specifically HFO or HFO+CMV then a statement will appear stating, “SLE5000 only”.
Page 15: Description Of The Ventilation Modes
2. Description of the Ventilation Modes The ventilator has the ability to be used as either a pressure controlled, volume targeted ventilator, as a pressure limited, time cycled ventilator, and the SLE5000 as a high frequency oscillation ventilator. 2.1 CPAP Continuous Positive Airway Pressure The ventilator generates a continuous positive airway pressure at a level set by the User.
Page 16: Cmv
2.2 CMV Continuous Mandatory Ventilation In this mode the inspiratory cycle is initiated by the ventilator at a set BPM rate. The breaths can be either time limited and pressure cycled or flow cycled and pressure limited. The User sets the following:- •...
Page 17: Ptv
2.3 PTV Patient Triggered Ventilation In this mode all the patient's breath attempts are pressure supported. Mechanical breaths are delivered at the set parameters (Ti, PEEP and PIP) if no patient effort is recognised. This mode can be used with or without a flow sensor. The User sets the following:- •...
Page 18: Ptv With Ttv
Note: PTV will continue to function as stated, but with breath rates of 20 and above apnoea alarms will be ignored by the ventilator. Breath rates of 20BPM and above are deemed sufficient to support the patient. Should the breath rate be set below 20BPM the apnoea alarm is enabled.
Page 19: Psv
2.4 PSV Pressure Supported Ventilation This is a pressure limited mode of ventilation in which each breath is patient triggered and supported. The breath is patient triggered, pressure supported and patient terminated. The infant therefore has control of the whole cycle, i.e. the inspiratory time, frequency and minute volume.
Page 20: Psv With Ttv
PSV Flow and Tidal volume waveforms (with termination sensitivity). Note: PSV will continue to function as stated, but with breath rates of 20 and above apnoea alarms will be ignored by the ventilator. Breath rates of 20BPM and above are deemed sufficient to support the patient. Should the breath rate be set below 20BPM the apnoea alarm is enabled.
Page 21: Simv (Synchronized Intermittent Mandatory Ventilation)
2.5 SIMV (Synchronized Intermittent Mandatory Ventilation) The frequency of mandatory breaths is determined by the BPM control. When a mandatory breath is due an assist window opens and waits for a patient's inspiratory effort. When this occurs the ventilator delivers a synchronised breath (SIMV breaths). Once the breath has been delivered the assist window closes until the next set breath is due.
Page 22: Simv With Psv
Note: SIMV will continue to function as stated, but with breath rates of 20 and above apnoea alarms will be ignored by the ventilator. Breath rates of 20BPM and above are deemed sufficient to support the patient. Should the breath rate be set below 20BPM the apnoea alarm is enabled.
Page 23: Simv With Ttv
Enables Targeted Tidal Volume and selects volume to be delivered • Max PIP • Max Ti 2.6 HFO (SLE5000 only) High Frequency Oscillation In this mode, the ventilator shall deliver continuous high frequency oscillation. There is no patient interaction. The User sets the following:- •...
Page 24: Mode Controls
2.8 Mode controls 2.8.1 TTV Control Mode (Targeted Tidal Volume) The aim of TTV is to prevent over distension of the alveoli and thereby limit volutrauma. By targeting a selected tidal volume, and achieving and maintaining the tidal volume with pressure ventilation, also limits barotrauma.
Page 25: Technical Description
2.9 Technical Description The ventilator is a computer controlled ventilator. The computer is broken down into three electronic subsystems that are housed in the upper (electronic) section of the ventilator. The three sub systems are user interface, monitor and control. The interface subsystem controls the user interface, the display and the touch screen.
Page 26: User/Owner Responsibility
SLE, or parts which are otherwise approved by SLE. Equipment which is not functioning correctly or is otherwise in need of repair or maintenance...
Page 27 Operational and Clinical Warnings Page 27 of 292...
Page 28: Warnings
4. Warnings 4.1 Operational Warnings The following warnings must be read and understood before using the ventilator. Failure to do so could lead to injury or death of the patient. General The whole of this manual should be read and understood before using the ventilator. Operators must be suitably trained and clinically authorized for using the ventilator with patients.
Page 29 19. If the ventilator is adversely affected by equipment emitting electromagnetic interference then that equipment should be switched off or removed from the vicinity of the SLE5000. Conversely, if the ventilator is the source of interference to other neighbouring equipment, it should be switched off or taken to another location.
Page 30 31. Do not use solvent based cleaning solutions to clean the touch screen or covers. Humidifier / Patient Circuit 32. Use only SLE approved patient circuits. On no account should antistatic or electrically conductive tubing be used. 33. The humidifier used in the patient circuit must be operated and maintained in accordance with its manufacturer’s instructions.
Page 31: Clinical Warnings
“Circuit Disconnection Procedure” on page 138. 39. A new flow sensor is delivered clean, but not sterile. It should be autoclaved as described in the Cleaning and Disinfection Procedures prior to initial use. Use only SLE approved flow sensors (Part number: N5201).
Page 32 Circulatory abnormalities (reduced systemic or pulmonary venous return, hypotension, tachycardia, bradycardia, reduced cardiac output, excessive variability of blood pressure); Maintenance of an adequate airway is paramount in the infant or child undergoing high- frequency oscillatory ventilation. The following points should be stressed in airway management on units employing HFOV: 10.
Page 33 Ventilator Description Page 33 of 292...
Page 34: Ventilator Description
5. Ventilator Description Rear Cover Front cover Touch Screen Power On Flow Sensor Connector Exhalation Block Flap Proximal Airway Port Fresh Gas Port Exhalation Block Front View Page 34 of 292...
Page 35 Cooling louvres Battery Power Terminaton Switch RS232 & Viewlink Connector Exhaust port for Exhalation Block Mains Power Cable Air Supply Cell cover Inlet Oxygen Supply Mains Power Switch Inlet Fuse Holder Rear View Page 35 of 292...
Page 36 Silencer Guides Exhalation Block Guides Silencer Exhalation Block Clamp Exhalation Block Guides Exhalation Block Exhalation Block Port Page 36 of 292...
Page 37: Description Of Symbols And Buttons
6. Description of Symbols and Buttons Symbol Description Type BF connection (Situated on front panel). Type B device (Situated on rear panel). Read manual (Situated on rear panel). Date of Manufacture (Appears on serial number label). Do not dispose of as general waste (WEEE directive). (Appears on serial number label).
Page 38 Symbol Description Mains/Battery power indicator (Situated on front panel). Screen pause. Waveform display options. Display options and service data. Enables the Targated Tidal Volume Panel. Enables the breath detection threshold in the flow window. Night mode and Screen Lock. Return button. Returns the user to previous panel. Next Button.
Page 39 Symbol Description Wave shaping controls. Language selection. Alarm mute. Picture capture button. Stored Loop (Loop on display). Stored Loop (Loop in memory). Zoom in. Zoom out. Please wait symbol. (Displayed when storing loop). High Tidal Volume Alarm in mbar Cycle Fail Alarm in mbar. Returns the waveform windows to their default settings of: Pressure, Flow and Tidal volume.
Page 40 Symbol Description Pressure wave window with Flow versus Volume loop display. Pressure wave window with Flow versus Pressure loop display. Pressure wave window with Volume versus Pressure loop display. Pressure wave window and Tidal Volume wave window. Pressure wave window and Minute Volume wave window. Pressure wave window and Max pressure against time display.
Page 41 Symbol Description Indicates a warning in the manual. Indicates a note in the manual. Indicates a caution in the manual. Check list item. A table explaining all abbreviations within this manual can be found on page 284. Page 41 of 292...
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Page 43 User Interface Description Page 43 of 292...
Page 44: User Interface
7. User Interface Warning: Do not use a sharp instrument, such as a pen to activate the touch screen controls as the excessive pressure applied by the point will damage the touch screen membrane. Note: The ventilator touch screen works on a one touch principle. If the user touches the screen at two points, the first point touched is recognized and the second is ignored.
Page 45: Description Of User Interface Indicators
The touch screen as the name suggests is controlled by touch. When using the ventilator it is advisable to have clean dry hands (gloved hands will also activate controls). Only a small amount of pressure is required to activate a control. 7.2 Description of User Interface Indicators In the mode panel the user will find indicator lights next to functions that can be turned ON or OFF.
Page 46: Examples Of Control Use
7.3.1 Examples of Control Use The following section describes the use of each of the above controls. 7.3.1.1 Buttons Touch the mode select button and this will activate the mode select panel. Select the required mode. The mode selected will be highlighted by a colour change (from light green to dark green).
Page 47 7.3.1.3 Up / Down Arrows The arrows appear when a function or parameter which can be modified is selected. The up arrow increases the chosen value and the down arrow decreases the value. The arrow selected changes colour when touched. The arrow can be touched repeatedly to increment the parameter in individual increments or held down to rapidly change the value.
Page 48: Description Of The Mode Panel In Ventilation Off Mode
Mode Select Panel. The panel displays all the ventilation modes that can be selected. SLE4000 SLE5000 Selection of the mode has to be confirmed by pressing the Confirm button. (Note the confirm button flashes between green and white).
Page 49: Oxygen Alarm Test
7.4.3 Oxygen Alarm Test The Oxygen Alarm Test button activates the Oxygen Alarm Testing panel. This panel allows the user to test the High and Low Oxygen alarm prior to use. For a detailed description on how this test is carried out, See “Oxygen Alarm Test”...
Page 50: Flow
7.5.1 Flow On pressing the Flow button (D) the Calibrate Flow Sensor panel will be displayed. The Calibrate button (I) runs the calibration routine for the flow sensor. For more details on the Flow Sensor and calibration see page 182. The Return button returns the user to the Services panel.
Page 51: Alarm Volume
7.5.4 Alarm Volume On pressing the Volume Control button (G) the Alarm Volume panel will be displayed. The alarm volume panel allows the user to set the alarm sounder volume between 7 maximum and 3 minimum. The sounder level settings below 3 can not be selected as normal background noise could mask the alarm.
Page 52: Language Toggle
Displayed on this panel are four buttons: Language Toggle button (L) Waveform Display Sync button (M) Set Time and Date button (N) Version.. (O) The Return button returns the user to the Services panel. 7.6.1 Language Toggle The ventilator software can be supplied to the user with a secondary language installed.
Page 53: Version Information Panel
7.6.1.2 Set Time and Date The Set Time and Date button (N) allows the user to set the internal clock and calendar of the ventilator. The date and time is displayed above the pressure waveform window. Note: the ventilator uses the 24 hour clock system and Day/Month/Year date system.
Page 54: Monitor Services
7.7.1 Monitor Services On pressing the Monitor button (P) the Monitor services panel will be displayed. This panel displays the Two point O calibration button and the software version numbers for the monitor subsystem. Note: See section 21. on page 214 for information on the two point oxygen sensor calibration.
Page 55: Mode Panel Functions In A Ventilation Mode
7.8 Mode Panel Functions in a Ventilation Mode For each ventilation mode, extra mode specific functions are displayed in the panel (except HFO Only). SLE4000 & SLE5000 For CPAP Apnoea Setup, Set Trigger and TTV buttons. For CMV TTV button.
Page 56: Apnoea Setup For Cpap
7.8.2 Apnoea Setup for CPAP The Apnoea Settings panel allows the user to set the Apnoea detection time and to activate backup breaths if apnoea is detected. The Backup breaths function is activated by the ON/OFF toggle button (S) and the Apnoea Detect time is controlled by the Arrow controls.
Page 57: Ttv For Cpap, Psv, Ptv & Simv
7.8.4 TTV for CPAP, PSV, PTV & SIMV The Targeted Tidal Volume panel allows the user to turn ON or OFF volume targeting. Volume targeting (TTV) is activated by the ON/OFF toggle button (T). When Volume Limiting is ON the Tidal volume parameter panel appears allowing the Tidal Volume limit to be set.
Page 58: Pressure Support In Simv
7.8.8 HFO Activity (SLE5000 Only) The HFO activity panel allows the user to toggle between oscillations in both inspiratory and expiratory phases of the CMV waveform or just the expiratory phase.
Page 59: Alarm Panel
7.9 Alarm Panel The Alarm Panel displays all the alarm messages. The Adjust button (U) activates the alarm setup panel in the Mode panel area, plus any alarm threshold in the waveform windows. It also allows the user to jump directly to the flow sensor and oxygen cell calibration panels when their respective alarms are triggered (provided no other higher priority alarms are active).
Page 60: Default Waveform Windows
The SLE4000 ventilator default setting is to display: Pressure, Flow and Tidal volume waveforms for CPAP, CMV, PTV, PSV and SIMV. The SLE5000 ventilator default setting is to display: Pressure, Flow and Tidal volume waveforms for CPAP, CMV, PTV, PSV, SIMV and HFO. For HFO+CMV the ventilator will only display Pressure and Flow waveforms.
Page 61 The alarm thresholds are also displayed in these waveform windows. The scales in waveform windows autoscale to match the set ventilation parameters. When the ventilator is used without a flow sensor the default layout changes to exclude flow related waveforms. The ventilator can also display loops and trends.
Page 62: Alarm And Breath Detection Thresholds
7.11 Alarm and Breath Detection Thresholds The ventilator has the following user adjustable alarms and breath detection threshold. Default waveform windows (with flow sensor connected): High Pressure Low Pressure Breath detection High Tidal Volume Low Tidal Volume Minute volume graph (selected from graph options button): High Minute Volume Low Minute...
Page 63: How To Set An Alarm Threshold
7.12 How to Set an Alarm Threshold To adjust an alarm threshold press the Adjust button in the alarm panel. If no alarm condition is present the user will have to select the alarm threshold for modification. In an alarm condition the user on pressing the Adjust button will find that the crossed alarm threshold will automatically be selected.
Page 64 Note: The High and Low Pressure Alarm thresholds auto track the pressure waveform by 5mbar for conventional modes of ventilation and 10mbar for HFO modes. Note: In CPAP, PTV, PSV and SIMV modes, the Flow window has a breath detection threshold. This threshold is activated by the Set Trigger button or can modified in the same manner as an alarm threshold as described above.
Page 65 Note: The user can only adjust the alarm thresholds to 15mbar above the maximum PIP or 15mbar below the minimum pressure in conventional ventilation or 20mbar above the maximum PIP or 20mbar below the minimum pressure in HFO or combined mode ventilation (HFO + CMV). This safety feature stops the user setting the alarm threshold so high that in practice the alarm is turned off.
Page 66: Ventilation Parameters
7.13 Ventilation Parameters Each ventilation mode has a number of parameters that have to be changed to meet the clinical requirements. The interface displays the user definable parameters at the bottom of the touch screen. On power up the ventilator defaults to the stand by mode and only displays the FiO parameter.
Page 67 The parameters can be selected and modified in the same way as in the preview mode. In the preview mode the parameters panel displays the set value. In the ventilation mode the parameters panel displays the measured value in the centre of the eyebrow and the set value in the right hand corner.
Page 68: Lung Mechanics And Measurement Panel
7.14 Lung Mechanics and Measurement Panel This panel displays the measured and calculated ventilation parameters. When no flow sensor is fitted only non flow based values are displayed. The panels shown display the parameters for each ventilation mode. SLE4000 & SLE5000 SLE5000 Only CPAP HFO+CMV SIMV Note: For CMV the IE ratio is replaced with measured Ti when TTV is on.
Page 69 Vmin (l) Minute volume is the accumulated expiratory tidal volume over a one-minute period. A measured value in litres. Texp(s) Total expiration time in seconds. A measured value. Leak(%) Percentage leak from the patient circuit. The difference between the expired volume compared to the inspired volume as a percentage.
Page 70: The Pause Button
7.15 The Pause Button The pause button is located in the top right hand corner of the screen. Pressing the button will freeze all the waveform windows for 1 minute. Pressing the pause button at any time whilst the screen is frozen will unfreeze the waveform windows.
Page 71 Loops, Trends & Waveforms Page 71 of 292...
Page 72: Loops, Trends & Waveforms
8. Loops, Trends & Waveforms This chapter details the way the ventilator displays patient data. The ventilator displays the realtime data collected from the proximal airway pressure transducer and ET manifold mounted flow sensor to provide Pressure, Flow and Tidal Volume waveforms.
Page 73 This means that the waveforms remain static (they do not creep from left to right) in the windows. For interactive ventilatory modes the data is enhanced by displaying the patient trigger in a different colour. To view the trigger point the ventilator colours the first 200 milli seconds orange, after the patient effort that has crossed the breath detection threshold.
Page 74: Loops
8.2 Loops The ventilator displays the following three loops: flow versus volume, flow versus pressure and volume versus pressure. The ventilator draws three loops before refreshing the window. Each loop is coloured differently in each three loop cycle. The colours being red, green and black.
Page 75 The ventilator will display the time and date that the loop was saved as it copies the data to memory. The ventilator will now display the saved looped and the current active loops. Step 3. Stored Loop button Note: When viewing a stored loop the active loops are shown as dashed lines.
Page 76: Trends
8.2.1.2 Retrieving Loops The user can retrieve a loop by pressing the Stored Loop button in the loop window. Note: The ventilator will revert to the axis scale of the stored loop. This could cause the current active loop to be drawn partially off the window. 8.3 Trends The ventilator can display eight different trends, these being Minute Volume, Max Pressure, Mean Pressure, Min Pressure, FiO...
Page 77 Ventilator Set-up Page 77 of 292...
Page 78: Ventilator Set-Up
9. Ventilator Set-up Note: The ventilator cannot be started on battery power. 9.1 Preparing the Ventilator for Use To prepare the ventilator for functional testing and later patient ventilation, carry out the following steps. Step 1 Cleaning Make sure that the ventilator has been cleaned in accordance with the instructions in “Cleaning, Disinfection and Sterilization”...
Page 79 Step 3 Connection of Oxygen and Air Hoses to the Gas Supplies Oxygen outlet Air outlet Oxygen supply hose Air supply hose Plug into the gas supplies, at a gas pressure of about 4 bar. Step 4 Connection of Mains Power Check mains power switch is set to OFF (O) Connect plug to mains switch and turn on at...
Page 80 Step 5 Fit the Exhalation Block and Silencer to the Gas Manifolds Connect the silencer to the exhalation block and then place the assembly onto the gas mainfolds (C). Lock the exhalation block by turning the clamp through 90 degrees until it is vertical (D).
Page 81 Supply Line Humidifier Water Trap Connect the SLE approved patient circuit as shown in the diagram above (F). Note: Patient circuit type and design may vary from the diagram Fit the humidification chamber into the humidifier. Page 81 of 292...
Page 82: Setup Related Items
Step 7 Setup Complete The ventilator is now ready for functional testing. Now see "Functional Testing" on page 94. 9.2 Setup Related Items 9.2.1 Shutting Down of the Ventilator The ventilator contains a battery back-up power supply that will continue to operate the ventilator in the event of a power failure.
Page 83 Quick Setup Guide Page 83 of 292...
Page 84: Quick Setup
200, then the unit should not be used until it has been repaired. Please contact an SLE approved engineer, or SLE. Warning: The settings used for the quick setup of the ventilator do not bear any relation to settings for ventilation of a patient.
Page 85: Complete Power Fail Alarm Test
10.0.1 Complete Power Fail Alarm Test. Step 1 The ventilator has a complete power fail alarm. This alarm is activated when both mains power and back-up battery power fail. This alarm is a high pitched, continuous tone emitted by the ventilator in the event of complete power failure. Turn ON the ventilator allow the start up screen to clear and wait for it to enter the Ventilation Off mode.
Page 86: Calibration Of The Flow Sensor
10.0.2 Calibration of the Flow Sensor Step 2 Make sure that there is no flow passing the through the sensor. For this purpose, occlude the flow sensor by holding it between two fingers, closing both ends as shown in the following picture. Press the Options and Service Data button.
Page 87: Low Oxygen Alarm Test
10.0.3 Low Oxygen Alarm Test Step 3 In Ventilation Off mode panel press the Oxygen Alarm Test button. The Oxygen alarm testing window will now be displayed in the Mode Panel. With the Alarm Auto-Track button set to ON set the FiO parameter to 45% O Once set, press the Alarm Auto-Track button.
Page 88 Step 4 Press the Mode Select button to enter the Mode select panel. Step 5 From the Mode Select panel select CPAP, press the confirm button. Page 88 of 292...
Page 89: Apnoea Alarm
10.0.4 Apnoea Alarm Step 6 Set the following parameters in the CPAP: Ti......1 sec CPAP ....5 mbar PIP....... 20 mbar ..... 21% Verify that: The visual and audible Apnoea alarm is triggered after 20 seconds. Step 7 Pull the test lung to mimic a breath, then acknowledge and reset the alarm. Verify that: a manual breath is delivered when the manual breath button is pressed.
Page 90: Leak / Block Alarm
10.0.5 Leak / Block Alarm Step 11 Disconnect the fresh gas tubing from the ventilator. This should initiate an audible and visual LEAK alarm indication. Step 12 Occlude the fresh gas outlet. This should initiate an audible and BLOCK visual alarm indication. Reconnect the tubing, audible and visual alarms should reset.
Page 91: Functional Test Of Hfo+Cmv Mode
For the SLE4000 ventilator: Select Ventilation Off from the Mode Select panel. Press the confirm button. Advance to set Step 18 For the SLE5000 ventilator: Select HFO+CMV from the Mode Select panel, but press the confirm button. Advance to Step 15.
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Page 93 Functional Testing Page 93 of 292...
Page 94: Functional Testing
200, then the unit should not be used until it has been repaired. Please contact an SLE approved engineer, or SLE. Warning: The settings used in the functional testing of the ventilator do not bear any relation to settings for ventilation of a patient.
Page 95: Stage 1 Functional Testing
Stage 1 Functional Testing 11.1 Stage 1 Functional testing 11.1.1 Complete Power Fail Alarm Test. Step 1 The ventilator has a complete power fail alarm. This alarm is activated when both mains power and back-up battery power fail. This alarm is a high pitched, continuous tone emitted by the ventilator in the event of complete power failure.
Page 96: Setting Fio
11.1.2 Setting FiO Step 2 In the ventilation off mode select the FiO parameter and using the arrow keys set the value to 21% FiO The ventilator defaults to 21% on start up.The measured value will be displayed once the O cell has finished it’s self calibration routine.
Page 97 From the services panel press the Flow button (A) With the flow sensor now occluded press the Calibrate button (B). This initiates the calibration cycle for the flow sensor. Keep the sensor occluded until the words “Calibration Complete” appear above the Calibrate button. The sensor has now been calibrated and can be fitted into the patient circuit.
Page 98: Oxygen Alarm Test
11.1.5 Oxygen Alarm Test Step 5 In ventilation off mode panel press the Oxygen Alarm Test button. The Oxygen alarm testing window will now be displayed in the Mode Panel. With the Alarm Auto-Track button set to ON set the FiO parameter to 45% O Once set, press the Alarm Auto-Track button.
Page 99 Decrease the percentage of oxygen to 37%. The blender will reduce the percentage of oxygen to the set value. The Low Oxygen Alarm will now be triggered. Further decrease the percentage of oxygen to 21% and press the Return button to cancel the Oxygen alarm test.
Page 100: Function And Alarm Testing
11.1.6 Function and Alarm Testing Step 8 Set the following parameters in the CPAP preview mode: Ti ......1 sec CPAP ....5 mbar PIP .......20 mbar ......21% After pressing the confirm button the user will be presented with the CPAP screen. Set the high alarm to 30 mbar Step 9 Check that:...
Page 101 Note: If functional testing the ventilator without a flow sensor fitted the TTV button will not appear and the Flow v Time & Tidal Volume v Time windows will be replaced by the Breath Trigger Level bar. Step 11 Pull the test lung to mimic a breath, then acknowledge and reset the alarm. Verify that: after 20 seconds the visual and audible Apnoea alarm is triggered.
Page 102 Pull the test lung to mimic a breath, then acknowledge and reset the alarm. Verify that: after 10 seconds that the ventilator delivers a backup breath and the visual and audible Apnoea alarm is triggered. Note: Functional testing with a flow sensor, but with the patient circuit occluded, the Breath Not Detected alarm will be triggered on the second mechanical breath.
Page 103 Step 17 Press the Mode Select button and select CMV from the Mode Select panel, but Do Not press the confirm button. Advance to Step 18. Step 18 Set the following parameters in the CMV preview mode: BPM..... 30 Ti......1 sec PEEP ....
Page 104: High Pressure Alarm
11.1.7 High Pressure Alarm Step 20 Reduce high alarm setting to 19mbar. This should initiate an audible alarm and a High Pressure visual alarm. Reduce the high alarm threshold a further 6mbar below the measured PIP. The high pressure alarm should remain but all fresh gas should now be cut off.
Page 105: Breath Not Detected Alarm
11.1.9 Breath Not Detected Alarm Step 22 Set the PEEP to 1 mbar Remove the test lung from the flow sensor. Occlude the flow sensor. After 10 seconds this should initiate an audible and visual Breath Not Detected alarm. Refit the test lung to the flow sensor. The Alarm should self cancel.
Page 106: Leak / Block Alarm
11.1.10 Leak / Block Alarm Step 23 Disconnect the fresh gas tubing from the ventilator. This should initiate an audible and visual LEAK alarm indication. Step 24 Occlude the fresh gas outlet. This should initiate an audible and visual BLOCK alarm indication. Reconnect the tubing, audible and visual alarms should reset.
Page 107: Gas Supply Alarms
11.1.12 Gas Supply Alarms Warning: Disconnect the gas supplies from the wall outlet only. DO NOT unscrew the hose connections from the rear of the ventilator. Step 26 Disconnect Air supply from wall outlet, an audible / visual alarm should be activated.
Page 108: Flow Sensor Disconnect Alarm
11.1.13 Flow Sensor Disconnect Alarm Note: If functional testing without the flow sensor advance to Step 30. Step 29 Disconnect the flow sensor plug from the ventilator an audible / visual alarm should be activated. Press the Continue without flow button. 11.1.14 Cycle Fail Alarm When the ventilator is used without a flow sensor a Cycle Fail alarm threshold...
Page 109 For the SLE4000 ventilator: Select Ventilation Off from the Mode Select panel. Press the confirm button. Advance to Step 42. For the SLE5000 ventilator: Select HFO Only from the Mode Select panel, but do not press the confirm button. Advance to Step 34.
Page 110: Functional Test Of Hfo Mode
11.1.15 Functional Test of HFO Mode Step 34 Set the following parameters in the HFO Only preview mode HFO Rate.....10Hz Mean ....5mbar ......21% Delta P ....Not available in preview mode After pressing the confirm button the user will be presented with the HFO screen.
Page 111 Note: If functional testing the ventilator without a flow sensor fitted the Flow v Time & Tidal Volume v Time windows will not appear. Press the Mode Select button and select HFO+CMV from the Mode Select panel, but do not press the confirm button. Advance to 11.1.16.
Page 112: Functional Test Of Hfo+Cmv Mode
11.1.16 Functional Test of HFO+CMV Mode Step 36 For the functional test set the following parameters in the HFO+CMV preview mode BPM .....30 Ti ......1 sec HFO Rate.....10Hz PEEP....4mbar PIP .......30 mbar Delta P ....Not available in preview mode ......21% After pressing the confirm button the user will be presented with the HFO + CMV screen.
Page 113 Note: If functional testing the ventilator without a flow sensor fitted Flow v Time & Tidal Volume v Time windows will not appear. Step 37 Verify that: the ventilator cycles with oscillations in both the inspiratory and expiratory phases the waveforms appear in the waveform windows the I:E ratio in the breath parameter panel reads 1.0 : 2.0 Step 38 Press the HFO Activity...
Page 114: Pressure Change Alarm
11.1.17 Pressure Change Alarm Step 40 Disconnect the flow sensor and test lung from the ET manifold for a maximum of 3 seconds then reconnect. Verify that: the visual and audible Pressure Change Detected alarm is triggered. Press the reset button to clear the alarm panel of the alarm notification.
Page 115: Stage 2 Functional Testing
Stage 2 Functional Testing 11.2 Stage 2 Functional testing The stage 2 testing routine must be carried out in conjunction with a stage 1 testing routine. 11.2.1 Functional Test of CMV Mode Step 43 For the functional test set the following parameters in the CMV preview mode: BPM.....
Page 116 Note: If functional testing the ventilator without a flow sensor fitted the Volume Limit button and the Flow v Time & Tidal Volume v Time windows will not appear. Step 44 Verify that: the ventilator is cycling, the I:E ratio in the breath parameter panel reads 1.0 : 1.0, the waveforms appear in the waveform windows.
Page 117 Step 46 Verify that: the pressure wave form is modified accordingly. Default position Midway position Step 47 Return the indicator bar to its original position and press the Return button to return to the Services panel panel. Step 48 Press the Next.. button to reach the More Options panel.
Page 118 Step 51 From the mode select panel press the TTV button. (Skip Step 51 to Step 55, if functional testing without a flow sensor). Step 52 Turn on the Volume targeting by pressing the button marked OFF. The text in the button will change to ON.
Page 119 Step 54 Set a Tidal volume of 8ml and a Max PIP of 30mbar Verify that: The displayed waveform changes showing a rise in flow with a sharp cut off. Step 55 Turn off the volume limiting. Step 56 Press the Mode Select button and select PSV from the Mode Select panel, but do not press the confirm button.
Page 120: Functional Test Of Psv Mode
11.2.2 Functional Test of PSV Mode Step 57 For the functional test set the following parameters in the PSV preview mode: Backup ....30 BPM PEEP....5 mbar PIP .......20 mbar Max Ti ....1 sec ......21% After pressing the confirm button the user will be presented with the PSV screen.
Page 121 Note: If functional testing the ventilator without a flow sensor fitted the TTV button will not appear and the Flow v Time & Tidal Volume v Time windows will be replaced by the Breath Trigger Level bar. Step 59 Press the PSV Setup button to display the Pressure Support panel.
Page 122 Step 60 Reduce the back up rate to 19 BPM. The Apnoea Setup button should now become active. Press the Apnoea Setup button on the Mode Panel. The Apnoea Settings panel should now be displayed. Set the apnoea detection to 10 seconds. Press the Return button to return to the Mode panel.
Page 123: Functional Test Of Simv Mode
11.2.3 Functional Test of SIMV Mode Step 63 For the functional test set the following parameters in the SIMV preview mode: BPM..... 30 Ti......1 sec PEEP ....4mbar PIP....... 25 mbar ..... 21% After pressing the confirm button the user will be presented with the SIMV screen.
Page 124 Note: If functional testing the ventilator without a flow sensor fitted the TTV button will not appear and the Flow v Time & Tidal Volume v Time windows will be replaced by the Breath Trigger Level bar. Step 64 Verify that: the ventilator cycles, the cycle waveform appears in the waveform windows, after 1 minute the BPM Tot should read 30 BPM in the breath...
Page 125 Note: Without the flow sensor fitted the user will only be able to set the triggered breath level percentage. Press the ON/OFF button (F) to activate pressure support. Wait for the ventilator to deliver a new mandatory breath, on completion of this breath pull the test lung, after the ventilator has delivered the synchronized breath, pull the test lung in approximately 0.5 second intervals.
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Page 127 Functional Test Check List Page 127 of 292...
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Page 129: Stage 1 Check List
12. Stage 1 Check List The ventilator must pass all the test’s. Pass Fail Step 1: Complete power fail alarm test. Audible alarm triggered and cancelled. Step 2: Setting FiO Measured value corresponds to set value. Step 5: Oxygen alarm test. High and Low alarms triggered.
Page 130 Pass Fail Step 23: Leak alarm. Alarm triggered and cancelled. Step 24: Block alarm. Alarm triggered and cancelled. Step 25: Mains failure alarm. Alarm triggered and cancelled. Step 26: Gas supply alarms. No Air supply Alarm triggered and cancelled. Step 27: Gas supply alarms. No O supply Alarm triggered.
Page 131: Stage 2 Check List
13. Stage 2 check list The ventilator must pass all the test’s. Pass Fail Step 44: CMV functional test. ventilator is cycling, waveforms appear and I:E ratio = 1:1. Step 46: Wave shape modified. Pressure wave modified. Step 49: Waveform display synchronisation. Waveforms should be displayed starting at the left hand edge of the window.
Page 132 Pass Fail Step 65: SIMV functional test. The ventilator delivers a synchronized breath. Step 66: SIMV functional test. The ventilator does not trigger on the 2 to 3 test lung initiated breaths before delivering the next synchronized breath. Step 67: SIMV functional test. The ventilator does not trigger on the 2 to 3 test lung initiated breaths before delivering the next synchronized breath, but provides...
Page 133 Operational Considerations Page 133 of 292...
Page 134: Operational Considerations
14. Operational Considerations 14.1 General 14.1.1 Ventilation Off Mode Warning: The user should never enter Ventilation Off mode when connected to a patient. The ventilator does not ventilate in this mode. 14.1.2 Gas Input Pressures The ventilator requires the gas input pressures to be between 4-5bar. The ventilator can operate with the gas pressures at 3-4bar, but when there is a high demand for gas, No O Supply or No Air Supply alarms can be triggered.
Page 135: Parameter Memory
Warning: Should the ventilator be in use in a mains power fail situation, the user must be aware that turning off the ventilator and terminating battery power will mean that the ventilator cannot be restarted, i.e the ventilator cannot be started on battery power. The ventilator can only be restarted once mains power has been restored.
Page 136: Breath Detection
14.1.10 Breath Detection The breath detection threshold needs to be set in all patient interactive modes. Setting the breath detection threshold at its most sensitive level (0.2ml) may allow the ventilator to interpret background noise in the patient circuit as patient breathing, resulting in auto-triggering.
Page 137: Overshoot
14.1.12.4 Continuing without flow with TTV ON When the user disconnects the flow sensor when ventilating in a mode with TTV ON, the ventilator on disconnection defaults the PIP level to 5 mbar above the set PEEP level, irrespective of what the user has set. 14.1.13 Overshoot Due to patient circuit and/or patient lung compliance overshoot may be present in the inspiratory part of...
Page 138: Circuit Disconnection Procedure
When the user now switches between TTV ventilation and standard ventilation the ventilator automatically switches between the two stored wave shape settings. 14.1.15 Circuit Disconnection Procedure Due to the method of monitoring of the flow sensor, under certain settings the ventilator can misinterpret the removal of the ET tube from the flow sensor (for endotracheal suctioning as an example) as flow sensor contamination.
Page 139: Bpm Tot. Measurement
14.1.16 BPM Tot. Measurement. The ventilator measures BPM in two different ways, with and without a flow sensor. When used without a flow sensor fitted, the ventilator measures pressure in the proximal airway tube to determine whether a breath has been delivered. Because of this monitoring of pressure, the BPM reading in the lung mechanics and measurement panel, displays the total number of machine delivered breaths (Mechanical breaths and triggered breaths).
Page 140: Alarms
14.2 Alarms 14.2.1 High and Low Alarm Operation The high and low alarm thresholds warn the user to a positive or negative increase in the pressure waveform. The high and low alarms are limited so that the user cannot set them so far above or below the pressure waveform that in practice they are turned Off.
Page 141: Minute Volume Alarm Threshold
Crossing the 20mbar ventilator set threshold If the high or low alarm threshold is exceeded by more than 20mbar the ventilator drops all the gas supplies for 6 seconds. It does not maintain the mean pressure and stops ventilating and this is true for all modes of ventilation. The ventilator will re-instate the fresh gas supply after 6 seconds and then restart ventilation a further 2 seconds after re-instatement of the fresh gas.
Page 142: Hfo Only Ventilator Set Threshold Alarms (Sle5000 Only)
14.2.5 HFO Only Ventilator Set Threshold Alarms (SLE5000 only) The user needs to be made aware that in HFO Only mode the ventilator sets 6 alarm thresholds that are invisible to the user. The thresholds are grouped in pairs and are as follows.
Page 143: Patient Leak Alarm
14.2.6 Patient Leak Alarm The user can modify the percentage at which the patient leak alarm is triggered or turn off the alarm all together. Note: If a patient leak alarm is triggered the user can reach the Patient Leak Alarm Limit panel in one action by pressing adjust button in the alarm panel.
Page 144: Patient Circuits, Humidification And Nitric Oxide Therapy
14.3 Patient Circuits, Humidification and Nitric Oxide Therapy 14.3.1 Patient Circuits with Incubators, Cots and Paediatric beds If using the ventilator to ventilate a patient in an incubator the user should select the N5188 or N5188/02 patient circuit. If using the ventilator to ventilate a patient in an IICS, Cot or Paediatric bed the user should select the N5188/02 patient circuit.
Page 145: Autofeed Humidification Chambers
14.3.2 Autofeed Humidification chambers When using autofeed humidification chambers the waterbag should be mounted higher than the max delta P or max PIP being used. To calculate the approximate height of the water bag use the following conversion: 1 mbar = 1cm, then add 25cm to the calcutated high for the final hight of the bag. Mounting the bag lower could allow the ventilator to pressurize the bag and thus prevent the chamber from filling with water.
Page 146: Nitric Oxide Therapy
When the ventilator is used in conjunction with an Inhaled Nitric Oxide Delivery System, the ventilator requires two NO scavenging filters (SLE part Nº N4110 connected in parallel with a dual exhaust hose assembly SLE part Nº N4110/10) fitted to the exhalation block (remove the silencer). This is supplied as a complete kit under SLE part Nº...
Page 147: Nebulization Of Medication
14.3.4 Nebulization of Medication When using a N2269 nebulizer kit with the N5188 patient circuit. The N2269 nebulizer requires an additional flow of gas which alters the prescribed set PIP and PEEP levels. Physical insertion of the N2269 nebulizer kit into the N5188 patient circuit. Disconnect the inspiratory limb (A) with amber restrictor from the ET manifold (B).
Page 148 Procedure Step 1 Note the set PIP and PEEP. Step 2 Disconnect the flow sensor cable from the ventilator and press the “Continue with out flow sensor” button. Step 3 Remove the flow sensor from the ET manifold. Step 4 Insert the nebulizer kit into the patient circuit.
Page 149 Flow and Pressure Tiggering Page 149 of 292...
Page 150: Flow And Pressure Triggering
15. Flow and Pressure Triggering 15.1 Breath Detection Threshold (Flow Triggering) When the ventilator is used with a flow sensor the flow waveform window contains a breath detection threshold. The breath detection threshold needs to be set in the following modes: CPAP, PTV, PSV and SIMV. The ventilator monitors gas flow to detect a patient breath.
Page 151: Breath Trigger Sensitivity (Pressure Triggering)
15.2 Breath Trigger Sensitivity (Pressure Triggering) The ventilator was designed primarily to be used with the N5201 flow sensor, but the ventilator can be operated without the flow sensor present. This changes the mode of operation of ventilator from a pressure ventilator with flow control to a pressure ventilator.
Page 152: Setting The Pressure Trigger Level In Cpap, Simv, Ptv And Psv
15.3 Setting the Pressure Trigger Level in CPAP, SIMV, PTV and PSV Note: The setting of the pressure trigger level can only be carried out once the ventilator is connected to a patient. Note: The Breath trigger sensitivity defaults to midway between min and max.
Page 153 Basic Setup Page 153 of 292...
Page 154: Basic Set-Up
The parameters stated in this chapter should never override the user choice of ventilator settings. Note: Only SLE approved circuits should be used with this ventilator. 16.1 Pre Set-up Checks Check that the humidifier is turned on. (Refer to the manufactures instructions for more details).
Page 155: Setting The Fio
16.2 Setting the FiO Step 1. In the Ventilation OFF mode select the percentage of FIO required per the prescription. Note: the FI0 can be set in the preview of each selected mode. Step 2. Select the required mode of ventilation. For CPAP see section 16.3 on page 156.
Page 156: Cpap Set-Up
16.3 CPAP Set-up Step 1. From the Mode Select panel select CPAP. Step 2. Default parameters in the preview mode: Ti ......0.4 sec (for manual breaths) CPAP ....2 mbar PIP .......10 mbar (for manual breaths) ......As per prescription Note: Ti (Insp. time) and PIP parameters are for the Manual and Back up Breaths.
Page 157: Actions After Connection To Patient In Cpap
16.3.1 Actions After Connection to Patient in CPAP Step 4. To adjust the Apnoea detection time and to activate backup breaths in the event of Apnoea press the Apnoea Setup button on the Mode Panel. The Apnoea Settings panel should now be displayed.
Page 158 TTV (Volume targeting) of backup breaths in CPAP. When the user selects TTV the PIP control becomes the MAX PIP control. The Max PIP control allows the user to set the maximum pressure at which a volume limited backup breath is delivered. In TTV the volume that the machine delivers is the limiting factor.
Page 159: Ventilation Without A Flow Sensor Connected
Step 9. If TTV (volume targeting) of the backup breaths is required, turn on the function and set the Max PIP and the Tidal Vol (Targeted Tidal Volume). The user may have to adjust the Low Tidal volume alarm threshold. Note: When TTV is discontinued the Max PIP returns to 5mbar above the set PEEP.
Page 160: Cmv Set-Up
16.4 CMV Set-up Step 1. From the Mode Select panel select CMV. Step 2. Default parameters in the preview mode: BPM .....30 Ti ......0.4 sec PEEP....2mbar PIP .......10mbar ......As per prescription Step 3. Press the Confirm button to enter the CMV mode. The ventilator will now start to ventilate at the set parameters.
Page 161: Actions After Connection To Patient In Cmv
16.4.1 Actions After Connection to Patient in CMV Step 4. The High and Low Pressure Alarm thresholds auto track the pressure waveform by 5mbar. The alarm thresholds can be adjusted if required. The thresholds are found in the pressure waveform window. High Step 5.
Page 162: Ventilation Without A Flow Sensor Connected
TTV (volume targeting) all mechanical breaths in CMV. When the user selects TTV the PIP control becomes the MAX PIP control. The Max PIP control allows the user to set the maximum pressure at which a volume limited backup breath is delivered. In TTV the volume that the machine delivers is the limiting factor.
Page 163: Ptv Set-Up
16.5 PTV Set-up Step 1. From the Mode Select panel select PTV. Step 2. Default parameters in the preview mode: Backup....30 BPM Ti......0.4 sec PEEP ....2 mbar PIP....... 10 mbar ..... As per prescription Note: Ti and PIP parameters are for the manual and back up breaths. Step 3.
Page 164: Actions After Connection To Patient In Ptv
16.5.1 Actions after connection to patient in PTV Step 4. Adjust the Backup parameter to the desired BPM rate. Step 5. If the backup breath rate is 19 BPM or lower the Apnoea setup is activated. Press the Apnoea Setup button on the Mode Panel. The Apnoea Settings panel should now be displayed.
Page 165 Interactive and limiting controls in PTV. The user needs to be aware that the following controls interact. The PEEP control interacts with the PIP control. When increasing the PEEP pressure, the PIP pressure will track accordingly if initially below the starting PEEP level.
Page 166: Ventilation Without A Flow Sensor Connected
Step 9. If required, set the minute volume alarms. The alarm thresholds are found by selecting the minute volume graph . Once set the user can revert to the default waveform display. Note: The user cannot set the high and low minute volume alarms when the flow sensor is not connected.
Page 167: Psv Set-Up
16.6 PSV Set-up Step 1. From the Mode Select panel select PSV. Step 2. Default parameters in the preview mode: Backup....30 BPM Max Ti....0.4 sec PEEP ....2 mbar PIP....... 10 mbar ..... As per prescription Note: Ti and PIP parameters are for the manual and back up breaths. Step 3.
Page 168: Actions After Connection To Patient In Psv
16.6.1 Actions After Connection to Patient in PSV Step 4. Adjust the Backup parameter to the desired BPM rate. Step 5. If the backup breath rate is 19 BPM or lower the Apnoea setup is activated. Press the Apnoea Setup button on the Mode Panel.
Page 169 Interactive and limiting controls in PSV. The user needs to be aware that the following controls interact. The PEEP control interacts with the PIP control. When increasing the PEEP, the PIP will track accordingly if initially below the starting PEEP level. The PIP control is limited by the PEEP.
Page 170: Ventilation Without A Flow Sensor Connected
Step 10. If TTV (volume targeting) of the triggered and mechanical breaths is required, turn on the function and set the Max PIP and the Tidal Vol (Targeted Tidal Volume). The user may have to adjust the Low Tidal volume alarm threshold. Note: When TTV is discontinued the Max PIP returns to 5mbar above the set PEEP.
Page 171: Simv Set-Up
16.7 SIMV Set-up Step 1. From the Mode Select panel select SIMV. Step 2. Default parameters in the preview mode: BPM..... 30 Ti......0.4 sec PEEP ....2mbar PIP....... 10 mbar ..... As per prescription Step 3. Press the Confirm button to enter the SIMV mode.
Page 172: Actions After Connection To Patient In Simv
16.7.1 Actions After Connection to Patient in SIMV Step 4. Adjust the BPM parameter to the desired BPM rate. Step 5. If the backup breath rate is 19 BPM or lower the Apnoea setup is activated. Press the Apnoea Setup button on the Mode Panel.
Page 173 Interactive and limiting controls in SIMV. The user needs to be aware that the following controls interact. The BPM and Ti controls interact. Increasing the number of breaths per minute can decrease the inspiratory time. Increasing the Insp time can decrease the number of breaths per minute.
Page 174 Step 8. Set the Breath Detection threshold for Apnoea settings. The threshold is found in the flow waveform window. (This waveform will not appear when operating without a flow sensor). Breath Detection Step 9. If required, set the minute volume alarms. The alarm thresholds are found by selecting the minute volume graph .
Page 175: Ventilation Without A Flow Sensor Connected
Note: Without the flow sensor connected the user will only be able to set the “Triggered breath level set to” percentage. Note: If TTV is ON the termination sensitivity and provide support values for non SIMV breaths will only come into effect if the targeted tidal volume could not be reached.
Page 176: Hfo Only Set-Up (Sle5000 Only)
16.8 HFO Only Set-up (SLE5000 only) Step 1. From the Mode Select panel select HFO Only. Step 2. Default parameters in the preview mode: HFO Rate.....10Hz Mean ....2mbar Delta P ....Can not be set in the preview mode Default value 4 mbar ......As per prescription...
Page 177: Actions After Connection To Patient In Hfo
16.8.1 Actions After Connection to Patient in HFO Step 4. Adjust the Delta P parameter as required. Note: Do not press the autoset button in the alarm panel until the required Delta P has been set. Pressing the autoset button before adjustment will only cause the unexpected drop/rise alarm to be re-triggered on changing the Delta P setting.
Page 178: Hfo+Cmv Set-Up (Sle5000 Only)
16.9 HFO+CMV Set-up (SLE5000 only) Step 1. From the Mode Select panel select HFO+CMV. Step 2. Default parameters in the preview mode: BPM .....30 Ti ......0.4 sec HFO Rate.....10Hz PEEP....2mbar PIP .......10 mbar Delta P ....Can not be set in the preview mode Default value 4 m ......Set as per prescription...
Page 179: Actions After Connection To Patient In Hfo+Cmv
16.9.1 Actions After Connection to Patient in HFO+CMV Step 4. The user can select which type of HFO activity is required by pressing the HFO Activity Button on the Mode panel. Select the mode required and press the Return Button. Limiting controls in HFO+CMV The user needs to be aware that the following controls interact.
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Page 181 Flow Sensor Care Page 181 of 292...
Page 182: N5201 Flow Sensor
To minimise dead space the sensor body fills much of the ET tube adapter and patient circuit connection. The ventilator flow sensor (SLE Part Nº N5201) is designed to measure flow rates that do not exceed 30 LPM. Do not use this flow sensor to monitor patients with ET tube sizes larger than 5.0 mm or that require more than 30 LPM.
Page 183 With the sensor now occluded press the Calibrate button (A). This initiates calibration cycle for the flow sensor. Keep the sensor occluded until the words Calibration Complete appears above the Calibrate button. The sensor has now been calibrated and can be fitted into the patient circuit.
Page 184: Cleaning And Sterilization
17.2 Cleaning and Sterilization Remove the flow sensor connecting cable before any cleaning, disinfection or sterilisation. Rinse the sensor body immediately after use and put it into a disinfectant (recommended by the infection control authority of the hospital / organisation), otherwise the sensor will encrust and cannot be used any more.
Page 185 Prior to first use as well as after each use Clean or Disinfect/Sterilize the sensor. Cleaning: A soap solution or mild alkaline solution should be used. Disinfection: Use commercially available disinfectants that are recommended for use with PLASTIC MATERIALS. Immersion times and concentrations stated must be in accordance with manufacturer’s instructions Note:...
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Page 187 Frequently Asked Questions Page 187 of 292...
Page 188: Frequently Asked Questions
18. Frequently Asked Questions 18.1 Ventilator Related Questions 18.1.1 What range of patients is the ventilator designed to ventilate? The ventilator is designed to ventilate neonates, infants and paediatric patients from 400gms to 20kg. 18.1.2 Can the ventilator be used without a flow sensor? Yes.
Page 189: What Happens When The Pause Button Is Pressed
18.1.6 What happens when the Pause button is pressed? Pressing the Pause button will freeze all the waveform windows for 1 minute. Whilst the waveforms are frozen ventilation does continue. Pressing the Pause button anytime whilst the waveforms are frozen will unfreeze the waveforms 18.1.7 What is the operating time of the battery? The battery is able to operate for 60 minutes.
Page 190: Mode Related Questions
18.2 Mode Related Questions 18.2.1 What is meant by Targeted Tidal Volume? The user selects the appropriate volume. This volume is then achieved, limited, and maintained by pressure. Changes in resistance and compliance are automatically accommodated. 18.2.2 What are appropriate Tidal Volumes? Preterm infants 4 - 6ml/kg Term infants 4 - 8ml/kg Paediatric patients 10 - 12ml/kg...
Page 191: Why Is There No Set Value For Map And Dp In Hfo Mode
18.3.6 Should bacterial filters be used on the expiratory limb? SLE recommends the use of a single use bacterial filter on the expiratory limb as a way of preventing contamination of the ventilator and the environment. It does need to be changed every 24hrs, or if wet at any time. A wet bacterial filter will no longer filter bacteria and will also cause an increase in pressure.
Page 192: How Often Does The Exhalation Block And Silencer Need To Be Autoclaved
18.3.8 How often does the exhalation block and silencer need to be autoclaved? Both the exhalation block and the silencer need autoclaving after each patient. The silencer can be autoclaved up to 25 times. Thereafter the plastic ends may become brittle and crack. 18.3.9 How do I clean the exhalation block and scavenging system after using NO? All patient circuitry must be single use.
Page 193 Commonly Seen Alarms Page 193 of 292...
Page 194: Commonly Seen Alarms
The low pressure threshold is automatically set at 1mbar on power and should not be adjusted to a level below that. (SLE5000 Only). The alarm thresholds are set 10 mbar above and below peak pressure in HFO. If the PIP is more than 5 mbar above the alarm limit, the gasses will be cut and the ventilator will attempt to restart HFO within 6 seconds.
Page 195: Unexpected Rise Or Drop In Mean P (Sle5000 Only)
19.0.5 Unexpected Rise or drop in Mean P (SLE5000 only) In HFO mode MAP alarms are automatically set at 5 mbar above and below the mean pressure level. This is not a user set alarm and is not shown anywhere on the screen.
Page 196: High Patient Leak
19.0.10 High Patient Leak This “Leak” is the leak measured around the distal end of the endotracheal tube. Infant ET tubes are uncuffed and therefore there will be a leak around the end if the tube. The smaller the tube the greater the leak is likely to be. It is measured as a percentage and is the difference between what was inspired compared to what was expired.The user is able to set the “Leak Alarm”...
Page 197: Calibration Fail
19.0.13 Calibration Fail For some reason the flow sensor will not calibrate, even if the message has been “Calibration Complete”. The reason could be that the sensor is defective due to mishandling, or has secretions preventing adequate flow through the sensor. Action: Handle sensor according to the guidelines laid out in the user manual.
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Page 199: Trouble Shooting Chart
Trouble Shooting Chart Page 199 of 292...
Page 200: Trouble Shooting Chart
20. Trouble Shooting Chart Warning: In all alarm conditions check the patient first. 20.1 Ventilator Related Problems Symptom Possible Cause Remedy Ventilator does not Mains power supply turned off. Turn on mains supply. power up when turned on but is Blown main fuse.
Page 201 Symptom Possible Cause Remedy Touch screen Touch screen failure. Remove patient to alternative buttons do not form of ventilation, then remove operate. ventilator from service. Refer ventilator to qualified service personnel. Total power fail Battery disconnect button not Depress button fully to cancel alarm active fully depressed on power down.
Page 202 Symptom Possible Cause Remedy Controller failure A hardware/software fault has Remove patient to alternative alarm. developed within the ventilator. form of ventilation, then remove Alarm Message: ventilator from service. Controller Not Note alarm message and refer Responding. ventilator to qualified service (Displayed below personnel.
Page 203 Symptom Possible Cause Remedy Low pressure alarm Air and Oxygen supply failed. If generated whilst connected to with CPAP/PEEP/ a patient, remove patient to Mean at zero and alternative form of ventilation. PIP/Delta P at zero. Alarm Message: Check Air and Oxygen supplies/ Low Pressure.
Page 204 Symptom Possible Cause Remedy Pressure sensor A pressure sensor transducer Remove ventilator from service. drift alarm. has failed an internal system If generated whilst connected to Alarm Message: check. a patient, remove patient to Pressure Sensor alternative form of ventilation Drift.
Page 205 Symptom Possible Cause Remedy Connect flow sensor Flow sensor cable not Connect flow sensor cable and alarm. connected to ventilator. recalibrate flow sensor. Refit Alarm Message: sensor into patient circuit. If to Connect flow be used without sensor press sensor. “Continue without flow”...
Page 206 Symptom Possible Cause Remedy Fresh gas solenoid Pneumatic system failure. Remove patient to alternative fail alarm. form of ventilation, then remove Alarm Message: ventilator from service. Fresh Gas Note alarm message and refer Solenoid Fail. ventilator to qualified service personnel. High oxygen level Oxygen sensor drifting.
Page 207 Symptom Possible Cause Remedy Calibrate Oxygen The oxygen sensor has Recalibrate O2 sensor. cell alarm. registered >105% oxygen Alarm Message: concentration. If sensor at fault a new oxygen Calibrate Oxygen cell alarm will be generated. If Cell. this messages appears remove patient to alternative form of ventilation, then remove ventilator from service.
Page 208 Symptom Possible Cause Remedy High or low pressure A hardware fault has developed a) Check the alarm thresholds are set correctly. alarm with fresh gas within the pneumatic unit of the cut off. ventilator. b) Press the reset button to restart ventilation.
Page 209: Ventilation Related Problems
20.2 Ventilation Related Problems Warning: In all alarm conditions check the patient first. Symptom Possible Cause Remedy Tidal volume Flow sensor incorrectly Calibrate flow sensor. maintained despite calibrated. low PIP. Blocked Fresh Gas Fresh gas supply tube blocked Check the fresh gas supply line alarm.
Page 210 Symptom Possible Cause Remedy Unexpected rise in The mean pressure has Check ventilator pressures. mean P alarm. increased by more than 5mbar. Check the patient circuit. Alarm Message: Press autoset to for new alarm Unexpected rise in thresholds. mean P. Unexpected drop in The mean pressure has Check ventilator pressures.
Page 211 Symptom Possible Cause Remedy Clean flow sensor Flow sensor has become Remove sensor from patient alarm. encrusted with secretions. circuit. Alarm Message: Fit new flow sensor and Clean Flow calibrate. Sensor. Refit sensor into patient circuit. If no replacement sensor available press “Continue without flow”...
Page 212 Symptom Possible Cause Remedy Breath not detected ET tube blocked or Check the patient for air entry. alarm. disconnected. Check the patient circuit. Alarm Message: Breath Not Detected. High alarm Alarm threshold set very high. Set alarm threshold closer to threshold does not Check numerical value against waveform.
Page 213: Technical Information
Technical Information Page 213 of 292...
Page 214: Oxygen Calibration Routines
21. Oxygen Calibration Routines The ventilator has two oxygen cell calibration routines. The first calibration is the 100% oxygen calibration (one point). This calibration is carried out at the following intervals after the unit is turned on: 0.5 minutes, 30 minutes, 60 minutes, 90 minutes and then at 8 hourly intervals.
Page 215: Preventative Maintenance And Overhaul Schedule
22. Preventative Maintenance and Overhaul Schedule Warning: Preventative Maintenance, Overhaul and Calibration of this ventilator should only be carried out by an SLE trained hospital engineer or an SLE service engineer. Interval Maintenance type Kit type Part Nº 6 months...
Page 216: Rs232
23. RS232 This section describes the data format and connections for the serial interface of the infant ventilator. 23.1 Warnings for RS232 Any computer connected to the ventilator must be specified for medical use (i.e. it must comply with the requirements of BS-EN-60601:1990). Do not connect the RS232 port via the interface cable to other types of devices that do not comply to the requirements of BS-EN-60601:1990.
Page 217: Overview
23.3 Overview 23.3.1 Data and Pinout Description. Data Format: RS232-C compatible, 19200 bps, 8 data bits, 1 stop bit, no parity. The data output is a comma delimited ASCII text string terminated by carriage return and linefeed (<CR>,<LF>). There is 1 second between the start of consecutive text string transmissions.
Page 218: Parameter Descriptions And Format
23.3.3 Parameter Descriptions and Format The text string that is output contains 40 parameters. e.g. 60,2,6,10,23,100,4,2,100,1,0,5,20,0,45,20,30,160,280,0,45,0,15000,60,3,10,145 ,139,3,25,99,22,13,0,824,10,3275,6,39,64, A description of each parameter follows; 23.3.4 List of Parameters Details Param. Nº Description Units Set BPM breaths/minute 0 to 150 Set CPAP mbar Set CPAP pressure 0 to 35 mbar Set Tidal Volume...
Page 219 Details Param. Nº Description Units Set Termination Set percentage Sensitivity 0 to 50 = percentage of max. flow that triggers termination, if value < 0 then termination sens. is off Set Breath Trig. lpm for flow 2 to 200 (0.2 to 20lpm for flow Threshold triggering.
Page 220 Details Param. Nº Description Units Measured Exp. 0.1ml 0 to 32768 (0 to 3.2768 l) Volume Measured PEEP mbar -175 to 175 mbar Measured PIP mbar -175 to 175 mbar Measured FiO2 0 to 100 % Measured HFO Delta mbar -175 to 175 mbar Measured HFO Mean mbar...
Page 221: Table Of Current Alarm Condition Codes
23.3.5 Table of Current Alarm Condition Codes. Value Currently Displayed alarm condition No Current Alarms Oxygen Cell Disconnected Calibrate Oxygen Cell Oxygen Cell Exhausted O2 Calibration Fail High Oxygen Level Low Oxygen Level Monitor EEPROM Fail System Fail - Monitor Isolated System Fail Pressure Sensor Drift High Pressure Low Pressure...
Page 222 Battery Fault High Minute Volume Low Minute Volume Low Tidal Volume High Patient Leak Apnoea - Volume Breath Not Detected High Tidal Volume Blocked Fresh Gas Leaking Fresh Gas No O2 Supply No Air Supply No Gas Max. Pressure too low Fresh Gas Solenoid Fail Controller Failure - control subsys.
Page 223: Rs232 Connection Settings And Testing Data Output
Monitor/Display Comms Fail EEProm Flow data corrupt EEProm Oxygen data corrupt EEProm Pressure Offset data corrupt EEProm Pressure Gain data corrupt EEProm Pressure Time constant Data corrupt 23.4 RS232 Connection Settings and Testing Data Output Connect a standard serial cable from the ventilator to the test computer. Turn on the ventilator and allow it to enter ventilation off mode.
Page 224: Alarms
24. Alarms 24.1 Alarm Protocols The following descriptions summarizes the alarms to be generated by the ventilator. The alarms are sorted by their priority ratings. An alarm of a higher priority can interrupt a lower priority alarm, effectively, masking lower priority alarms.
Page 225: Alarm Descriptions And Actions To Be Taken
24.3 Alarm Descriptions and Actions to be Taken Alarm 1. Monitor Failure Alarm message........Monitor failure Alarm sub message ......Remove ventilator from service Priority of alarm........1 Monitor mode........N/A Can alarm be muted ......No Sounder Priority ........High Alarm Description: If the monitor system fails this alarm is generated by the controller system.
Page 226 Alarm 3. Sub-ambient Pressure Alarm message ........Sub ambient pressure Alarm sub message ......Safety shutdown activated and ventilator restarting Priority of alarm ........3 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: If the proximal pressure falls below -2mbar for <50ms a sub-ambient alarm is generated but mean pressure is maintained.
Page 227 Alarm 5. 101 System Fail (Memory Checksum Error) Alarm message........Monitor EEPROM fail Alarm sub message ......Monitor checksum Fail Alarm code........... 101 Priority of alarm........5 Monitor mode........All Can alarm be muted ......No Sounder Priority ........High Alarm Description: At power up flow data in EEPROM corrupt.
Page 228 Alarm 8. 104 System Fail (Memory Checksum Error) Alarm message ........Monitor EEPROM fail Alarm sub message ......Monitor checksum Fail Alarm code ...........104 Priority of alarm ........8 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: At power up pressure gain data in EEPROM corrupt. Action: Remove ventilator from service.
Page 229 Alarm 11. Continuing Positive Pressure Alarm message........Continuing positive pressure Alarm sub message ......Check patient circuit Priority of alarm........11 Monitor mode........All Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: When the ventilator detects a increase of 5mbar above the PEEP that is maintained for more than 10 seconds this alarm is generated.
Page 230 Alarm 14. Pressure Change Detected Alarm message ........Pressure Change Detected Alarm sub message ......Check Patient Connection Priority of alarm ........14 Monitor mode ........HFO+CMV only Can alarm be muted ......Yes Sounder Priority........High Alarm Description: When the user changes a pressure related parameter the ventilator stores the maximum inspiration and expiration pressure values.
Page 231 Alarm 17. Unexpected Rise in Mean P Alarm message........Unexpected rise in mean P Alarm sub message ......Press autoset to adjust HFO alarms to new pressures Priority of alarm........17 Monitor mode........HFO Only Can alarm be muted ......Yes Sounder Priority ........
Page 232 Alarm 20. Unexpected Drop in Max P Alarm message ........Unexpected drop in max P Alarm sub message ......Press autoset to adjust HFO alarms to new pressures Priority of alarm ........20 Monitor mode ........HFO Only Can alarm be muted ......Yes Sounder Priority........High Alarm Description: When the ventilator set alarm threshold of 5mbar below the max pressure is crossed this alarm is generated.
Page 233 Alarm 23. No Gas Alarm message........No gas Alarm sub message ......Connect ventilator to gas Priority of alarm........23 Monitor mode........All Can alarm be muted ......No Sounder Priority ........High Alarm Description: If no gas is detected by the ventilator this alarm is generated. Action: Connect gas supplies to ventilator.
Page 234 Alarm 26. Battery Fault Alarm message ........Battery fault Alarm sub message ......Internal battery not detected Priority of alarm ........26 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: The battery can not be detected by the ventilators monitoring system Action: Remove ventilator from service.
Page 235 Alarm 29. Leaking Fresh Gas Alarm message........Leaking fresh gas Alarm sub message ......Fresh gas supply to patient may be leaking Priority of alarm........29 Monitor mode........All Can alarm be muted ......No Sounder Priority ........High Alarm Description: If the fresh gas supply is detected to be leaking this alarm is generated.
Page 236 Alarm 32. Flow Monitor (Flow ADC Unable to Calibrate) Alarm message ........System Fail Alarm sub message ......Unable to calibrate flow ADC Priority of alarm ........32 Monitor mode ........Flow Can alarm be muted ......Yes Sounder Priority........High Alarm Description: Errors detected within the flow monitoring device. Action: Remove patient to alternative form of ventilation, then remove ventilator from service.
Page 237 Alarm 35. Connect Flow Sensor Alarm message........Connect flow sensor Alarm sub message ......Flow sensor is not connected Priority of alarm........35 Monitor mode........Flow Can alarm be muted ......Yes Sounder Priority ........Medium Alarm Description: If the sensor is not connected or both wires have been broken this alarm is generated. Action: Connect flow sensor, if sensor already in situ replace and discard the defective flow sensor.
Page 238 Alarm 38. User Interface Failure Alarm message ........User interface failure Alarm sub message ......User interface has reset unexpectedly Priority of alarm ........38 Monitor mode ........All Can alarm be muted ......Yes Sounder Priority........High Alarm Description: When a hardware reset has taken place within the ventilator this alarm is generated. Action: Remove patient to alternative form of ventilation, then remove ventilator from service.
Page 239 Alarm 41. Low Tidal Volume Alarm message........High tidal volume Alarm sub message ......Tidal volume below low threshold Priority of alarm........41 Monitor mode........Flow Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: Tidal volumes lower than a user-selected threshold will generate this alarm. Action: Check patient.
Page 240 Alarm 44. Breath Not Detected Alarm message ........Breath not detected Alarm sub message ......Check patient connection Priority of alarm ........44 Monitor mode ........Flow Can alarm be muted ......Yes Sounder Priority........Medium Alarm Description: If after a machine delivered breath the ventilator does not detect a patient response within 10 seconds then this alarm is generated.
Page 241 Alarm 47. Main Power Failure Alarm message........Main power fail Alarm sub message ......Running on internal battery Priority of alarm........47 Monitor mode........All Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: If the mains supply fails this alarm is generated. Action: Check mains connection.
Page 242 Alarm 50. Calibrate Oxygen Cell Alarm message ........Calibrate oxygen cell Alarm sub message ......The oxygen cell needs calibrating Priority of alarm ........50 Monitor mode ........All Can alarm be muted ......Yes Sounder Priority........Medium Alarm Description: If at any time the measured oxygen is >100% this alarm will be generated. Action: Recalibrate O sensor.
Page 243 Alarm 53. High Oxygen Level Alarm message........High oxygen level Alarm sub message ......The O is higher than desired Priority of alarm........53 Monitor mode........All Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: If the delivered oxygen differs from the user selected level by more than 5% the above alarm is generated.
Page 244: Software And System Fail Protocols
Alarm 56. Alarm Controller Fail Alarm message ........System Fail Alarm sub message ......Alarm Controller Fail Priority of alarm ........56 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: If the alarm controller fails this message is generated. Action: Remove patient to alternative form of ventilation, then remove ventilator from service.
Page 245: Bacterial Filters
The ventilator can be used without bacterial filters in place, but the user must take extra care in not allowing secretions or fluids to enter the ventilators gas ports. 25.1 Bacterial filter, SLE Part Nº:N2029 (Autoclavable) This autoclavable bacterial filter is fitted into the humidifier supply line and has to be fitted in accordance with the indicator arrow embossed on the surface of the filter.
Page 246: Bacterial Filter, Sle Part Nº: N2587 (Single Use)
25.2 Bacterial filter, SLE Part Nº: N2587 (Single use) This single use bacterial filter is fitted onto the exhalation block outlet. This filter should be disposed of in accordance with local hospital authority guidelines. A new filter should be used with each patient.
Page 247: Patient Circuits
The ventilator can use both single use and autoclavable patient circuits. 26.1 Warnings for Patient Circuit Use. Use only SLE approved patient circuits. Applicable to single use and re-usable patient circuits. Make sure that all connections are made properly and are tight before use.
Page 248: 10Mm Diameter Re-Usable Patient Circuit (Sle Part Nº N2391/50)
Clean and sterilize before and after use. It is recommended that a high quality bacteria filter (SLE part no. N2029) is fitted at the fresh gas connection to the humidifier inlet, however the circuit may be used without. Connect the patient circuit as shown in the diagram and described below.
Page 249 DIAGRAM INDEX A Proximal Airway Inlet 1 Humidifier Supply Line B Exhalation Port (From Patient) 2 Inspiratory Supply Line C Ø10 x 100 Tube Assembly 3 Expiratory Supply Line D Single Use Bacteria Filter 4 Proximal Airway Pressure Line E Autoclavable Bacteria Filter 5 Temperature Monitoring Port F ET Manifold 6 Inspiratory Supply Line...
Page 250: 10Mm Patient Circuit, Sle Part Nº N5188 & N5188/850
The SLE N5188/850 circuit has a clover leaf heater wire connector. It is recommended that a high quality bacteria filter (SLE part No. N2029) is fitted at the fresh gas connection to the humidifier inlet, however the circuit may be used without.
Page 251 N5188/850 DIAGRAM INDEX A. Proximal Airway K. Water Trap B. Exhalation Port (from patient) L. N2257 adaptor for MR225/290/390 chamber* C. Short Tube 1 Humidifier Supply Line D. Single Use Bacteria Filter 2 Inspiratory Supply Line E. Autoclavable Bacteria Filter 3 Expiratory Supply Line F.
Page 252: 10Mm Patient Circuit, Sle Part Nº N5188/02 & N5188/02/850
The SLE N5188/02/850 circuit has a clover leaf heater wire connector. It is recommended that a high quality bacteria filter (SLE part No. N2029) is fitted at the fresh gas connection to the humidifier inlet, however the circuit may be used without.
Page 253 N5188/02/850 DIAGRAM INDEX A. Proximal Airway K. Water Trap B. Exhalation Port (from patient) L. N2257 adaptor for MR225/290/390 chamber* C. Short Tube 1 Humidifier Supply Line D. Single Use Bacteria Filter 2 Inspiratory Supply Line E. Autoclavable Bacteria Filter 3 Expiratory Supply Line F.
Page 254: N5238/50 Heated Patient Circuit For No Therapy
Nitric Oxide Therapy System or SLE INOSYS Inhaled NO System. With dual hose scavenger filter. It is recommended that a high quality bacteria filter (SLE part no. N2029) is fitted at the fresh gas connection to the humidifier inlet, however the circuit may be used without.
Page 255 Hyrdophobic filter N4108 Monitor Line Bacteria Filter N4117/06 Delivery line DIAGRAM INDEX A. Proximal Airway K. Water Trap B. Exhalation Port (from patient) L. N2257 adaptor for MR225/290/390 chamber* C. Short Tube 1 Humidifier Supply Line D. Single Use Bacteria Filter 2 Inspiratory Supply Line E.
Page 256: Nitric Oxide Delivery Adaptor Kit (Sle Part Nº N2238/50)
This non-sterile circuit kit is for single patient use. It is designed to be used with an SLE type N5188 circuit, in combination with a Servo controlled humidifier (Fisher and Paykel Humidifier or equivalent) and an Inhaled Nitric Oxide Delivery System.
Page 257: Cleaning, Disinfection And Sterilization
62°C. DO NOT immerse any part of the ventilator in any liquid, with the exception of the expiratory exhalation block (SLE part No N6622). 27.1 Preparation of a New Ventilator Remove all transit packaging. Inspect the fresh gas port and proximal airway port for any packing material.
Page 258: Cleaning, Disinfection & Sterilization Chart
• Unlock the exhalation block by turning the clamp through 90 degrees until it is horizontal. • Gently pull away the exhalation block and silencer from the gas ports. • Separate the silencer and exhalation block. Refitting the silencer and exhalation block is the reversal of removal. Do not force the exhalation block into place.
Page 259: Disinfection Method
Ensure that the detergent solution does not enter the unit or the exhalation block gas ports on the side of the machine. (Touch Screen) Do not use any abrasive cleaners on the touch screen surface. Flow Sensor Wash in hand hot water/mild general purpose detergent solution (as prescribed by the appropriate hospital authority).
Page 260: Sterilization Method
27.5 Sterilization Method The silencer (N2186/01), flow sensor (N5201) and exhalation block (N6622) must be sterilized between use on patients. The ventilator cannot be sterilized. The exhalation block must be cleaned as an essential prerequisite to sterilization. For the silencer, flow sensor and exhalation block. Autoclave with pure dry saturated steam at: 134ºC (277ºF) (Allowable variation of temperature of +3ºC) at 220kPa (32psi) with a minimum holding time of 3 minutes...
Page 261: Technical Specification
28. Technical Specification This section summarizes the specification of the ventilator in terms of the modes, ranges and limits that are required on the controls and the displays. It also summarizes the mechanical and electrical power constraints. 28.1 Operating Modes Conventional Ventilation 28.1.1 CPAP Inspiratory Time: 0.1 to 3.0 seconds, steps of 0.01 seconds...
Page 262: Psv
28.1.4 PSV Inspiratory Time: 0.1 to 3.0 seconds, steps of 0.01 seconds CPAP Pressure: 0 mbar to 20 mbar Inspiratory Pressure: 0 mbar to 65 mbar Volume Targeting: 2 ml to 200 ml 21% to 100% Backup breaths are pressure limited, time cycled. 28.1.5 SIMV BPM: 1 to 150...
Page 263: Controls (Via Touch Screen Display)
28.2.3 Controls (Via touch screen display) Adjust button: Activates alarm thresholds for modification Alarm Auto-Track button: Sets selected %0 for testing Apnea Sup Button: Sends diagnostic pulse Apnoea setup button: Activates Backup/Apnoea settings panel Arrow buttons: Increments value up or down or scrolls left/right Auto set Button: Autoset high, cycle and low alarm thresholds Backup parameter control:...
Page 264 F/P Loop button: Selects flow versus pressure loop display Flow Trigger button Activates the breath detection threshold F/V Loop button: Selects flow versus volume loop display Graphs button: Activates waveform and loops panels HFO activity button: Activates HFO activity panel HFO Only button: Selects HFO only mode HFO rate parameter control:...
Page 265 PIP parameter control: 0 to 65 mbar Picture capture button: Stores loop to memory PSV button: Selects PSV mode PSV Setup: button: Activates pressure support panel PTV button: Selects PTV mode Reset button: Resets current alarm Reset contamination alarm Resets the alarm button: Resistance Trend Button Selects resistance against time display...
Page 266: Controls
28.2.4 Controls Battery power termination: Terminates backup battery power supply ON/OFF: Control for mains power supply 28.3 Measurement 28.3.1 Flow and Volume Flow Sensor Type: 10 mm dual-hot-wire-anemometer with replaceable hot- wire subassembly, autoclaveable. Sensor electrically isolated. Flow Rate: 0.2 lpm to 32 lpm (Accuracy ±8 % maximum) Expiratory Tidal Volume: 0 to 999ml (0.1ml) Expiratory Minute Volume:...
Page 267: Pressure
28.3.3 Pressure Real Time Pressure: Resolution 1mbar Drift detection: detects drift when there is a pressure difference of more than 5mbar between the two pressure transducers. Only active when the measured pressure is below 70mbar. Sampling Time: Peak Pressure: 0 to 175 mbar (resolution 1mbar) PEEP Pressure: 0 to 175 mbar (resolution 1mbar) Mean Pressure:...
Page 268: Alarms
28.4 Alarms 28.4.1 User settable Alarms High Pressure: Autoset when patient pressure controls are adjusted, or manually adjustable. Range: 10 to 110 mbar Resolution: 0.5 mbar Cycle Fail: Autoset when patient pressure controls are adjusted, or manually adjustable. Range: 0 or 5 mbar above low-pressure threshold (whichever is lower) to 5 mbar below high-pressure threshold.
Page 269: Obligatory Alarms (Non Adjustable By User)
28.4.2 Obligatory Alarms (non adjustable by user) Monitor Failure Sustained sub ambient Sub ambient Controller Failure System fail, Memory checksum error System fail, Alarm controller error Gas not connected not connected Air not connected Block alarm Leak alarm Battery fault Battery low Continuing positive pressure Pressure sensor drift...
Page 270: Outputs
Trigger Count Measured Minute Volume Measured Leak Measure Resistance Measured Compliance Measured C20/C Current Alarm ID For more details refer to the RS232 addendum. Contact SLE for more details. Compatability with: Vuelink. Contact SLE for more details. Page 270 of 292...
Page 271: Gas Supplies
28.7 Gas supplies Note: The ventilator requires the gas input pressures to be between 4-5bar. The ventilator can operate with the gas pressures at 3-4bar, but when there is a high demand for gas, No O Supply or No Air Supply alarms can be triggered.
Page 272: Power, Dimensions, Standards Etc
BS EN 60601-1-4: 1996 Medical Devices Directive (93/42/EEC) Patient Circuit Required: Model: 10 mm Single use for use with incubators (SLE Part Nº: N5188) Model: 10mm Single use for use cots (SLE Part Nº: N5188/02 Model: 10 mm Re-usable (SLE Part Nº: N2391/50) 28.9 Environmental Storage Conditions...
Page 273: Pneumatic Unit Schematic
29. Pneumatic Unit Schematic Below is a schematic representation of the pneumatic unit of the ventilator. Legend Page 273 of 292...
Page 274: Ventilator Labelling
30. Ventilator Labelling 30.1 SLE4000 Page 274 of 292...
Page 275: Sle5000
30.2 SLE5000 Page 275 of 292...
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Page 277 Consumables & Accessories Page 277 of 292...
Page 278: Consumables And Accessories
31. Consumables and Accessories Item Part N 10mm Patient Circuit (Single use) N5188 Temperature probe port 450mm from ET tube. Flying lead (Molex) heater wire connector. 10mm Patient Circuit (Single use) N5188/850 Temperature probe port 450mm from ET tube. Clover leaf heater wire connector. 10mm Patient Circuit (Single use) N5188/02 Temperature probe port at ET tube.
Page 279 Item Part N Bacteria filter (autoclavable) N2029 Bacteria filter (single use) N2587 (complete) 4 metres length N2035 Air hose, 4 bar (complete) 4 metres length N2199 MR850 Humidifier Heater Base. (230V) For UK Only N3850/00 MR850 Humidifier Heater Base. (230V) N3850/01 MR220 Single Use chamber.
Page 280 Item Part N MR559 Heater Adapter for use with Single Use N3559 patient circuits & chambers and MR700 Humidifier Heater Base MR558 Heater Adapter for use with Re-usable N3558 patient circuits & chambers and MR700 Humidifier Heater Base MR859 Heater Adapter for use with Single Use N3859 patient circuits &...
Page 281 Item Part N MR860 Dual Temperature Probe (for 850 F&P N3860 humidifier) Test Lung N6647 Basic pole and 5 star base M0770/80 Ventilator Cart with locking front castors, basket and N6627 medi rail. (Shelf height 82cm) Ventilator Cart with two locking castors, basket and N6650 medi rail.
Page 282 Item Part N Patient Circuit Arm N6627/212 5 micron particulate filter and watertrap, for air inlet. Z0005/05 User Manual for SLE4000/5000 N6626/05 Quick setup guide N6626/06 Service Manual for SLE4000/5000 N6645 Page 282 of 292...
Page 283 Glossary Page 283 of 292...
Page 284: Glossary Of Abbreviations Used In This Manual
32. Glossary of Abbreviations Used in this Manual ASCII (American Standard Code for Information Interchange) is the most common format for text files in computers. Not suitable for non-English letters but suitable for numerics. Oxygen °C Degrees Celsius °F Degrees Fahrenheit ≈...
Page 285 Low Frequency Litres per Minute mbar Millibar Millilitres Millisecond NEEP Negative End Expiratory Pressure Mean P Mean Pressure PEEP Positive End Expiratory Pressure Peak Inspiratory Pressure Pounds per Square Inch Patient Triggered Ventilation Resist. Resistance RS232C RS232 is a long established standard for low speed serial data communication, “C”...
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Page 287: Index
33. Index ......106 Alarm, Leak/block ....235 Alarm, Leaking Fresh Gas ........104 Alarm, Low ....239 Alarm, Low Minute Volume ... 284 Abbreviations, used in the manual ....243 Alarm, Low Oxygen Level ....59 Adjust Button, location .......
Page 288 .......189 ....50 Battery charging time Flow Button, description of .......68 BPM Tot, Value Flow Sensor Connecting Cable, Part Nº .135 ....31 BPM, measured and set parameters Flow Sensor Warnings......136 Flow Sensor, Calibration 86, 96, Breath Detection ....150 Breath detection threshold ....151 Breath Trigger Sensitivity...
Page 289 ........ 136 ....215 Max Ti in PSV Preventative Maintenance ....... 69 ..........55 Mean P, Value ..141 .... 120 Minute Voulme Alarm Threshold PSV mode, functional test of ......44 ....19 Mode panel location PSV, description of mode ....
Page 290 ..190 Targeted Tidal Volume, meaning ....261 Technical Specification .....58 Termination sensitivity .......68 Ti Meas., Value ......47 Ti parameter control ....135 Tidal Volume Parameter .....136 Tidal Volume Reading ..........72 Trends ......189 Trigger Sensitivity .........68 Trigger, Value ....57 TTV panel, description of ......24 TTV, control mode ......136...
Page 291 SLE reserves the right to make changes without prior notice in equipment, publications and prices as may be deemed necessary or desirable. Page 291 of 292...
Page 292 0120...

This manual is also suitable for:

Sle4000

SLE SLE5000 User Manual

1 Introduction

2 Description of the Ventilation Modes

3 User/Owner Responsibility

4 Warnings

5 Ventilator Description

6 Description of Symbols and Buttons

7 User Interface

8 Loops, Trends & Waveforms

9 Ventilator Set-Up

10 Quick Setup

11 Functional Testing

12 Stage 1 Check List

13 Stage 2 Check List

14 Operational Considerations

15 Flow and Pressure Triggering

16 Basic Set-Up

17 N5201 Flow Sensor

18 Frequently Asked Questions

19 Commonly Seen Alarms

20 Trouble Shooting Chart

21 Oxygen Calibration Routines

22 Preventative Maintenance and Overhaul Schedule

23 Rs232

24 Alarms

25 Bacterial Filters

26 Patient Circuits

27 Cleaning, Disinfection and Sterilization

28 Technical Specification

29 Pneumatic Unit Schematic

30 Ventilator Labelling

31 Consumables and Accessories

32 Glossary of Abbreviations Used in this Manual

33 Index

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Troubleshooting

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Summary of Contents for SLE SLE5000