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Instructions For Use V1.0: When The Smallest Thing Matters

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0% found this document useful (0 votes)
3K views

Instructions For Use V1.0: When The Smallest Thing Matters

JHJ

Uploaded by

Leandro Villamil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 206

SLE6000

Instructions for use


V1.0

When the smallest thing matters


This manual is only to be used with:
SLE6000 infant ventilators.
SLE Limited
Twin Bridges Business Park
232 Selsdon Road
South Croydon All rights reserved. No part of this publication
Surrey CR2 6PL may be reproduced, stored in any retrieval
system, or transmitted in any form or by any
means, electronic, mechanical, photocopy,
recording or otherwise, without prior permission
of SLE.
Telephone: +44 (0)20 8681 1414
Fax: +44 (0)20 8649 8570
E-mail: sales@sle.co.uk

Web site: www.sle.co.uk

Distributor

© Copyright SLE 25/04/2017


Document ref: UM154 Issue 6
UM154/UK

2
Fast index

Fast index
This index allows users to move directly to the areas
of interest. A full contents page is available on page
11.

Section Page

Patient circuit selection for invasive ventilation and modification for non invasive ventilation 30

Ventilator setup Invasive ventilation 46

Ventilator setup Non invasive ventilation - Dual limb patient circuit 62

Ventilator setup Non invasive ventilation - Single limb patient circuit 68

Ventilator setup Non invasive ventilation - High flow nasal cannula therapy 70

Invasive mode basic operation

CPAP 46

CMV 48

PTV 50

PSV 52

SIMV 54

HFOV 56

HFOV+CMV 58

Non invasive mode basic operation - Dual limb patient circuit

NCPAP 62

NIPPV 64

NHFOV 66

Non invasive mode basic operation - Single limb patient circuit

NCPAP 68

O2 therapy 70

Technical information

Description of user interface 84

Technical data 101

Troubleshooting 159

Functional testing 165

Installation instructions 178

3
Fast index

This page is intentionally left blank.

4
Intended use

Intended use
“Summary statement” on page 6
“Condition of use” on page 6

5
Intended use

1. Intended use of the SLE 6000 1.2 Condition of use


The SLE6000 ventilator is intended to provide
1.1 Summary statement continuous or intermittent respiratory support for
The SLE6000 ventilator is intended to provide premature and term neonates, infants, and
continuous or intermittent respiratory support for paediatric patients depending on condition.
premature and term neonates and infants, as well The ventilator is mobile when trolley mounted but
as paediatric patients up to 30kg depending on intended for static operation in a hospital intensive
condition. care unit in normal use.
The ventilator is intended for use in either invasive The ventilator is intended for use within an
or non-invasive applications. The SLE6000 with appropriate medically clean environment, with
HFO option offers additional high frequency medical grade Air and Oxygen and with appropriate
oscillation modes. MEDICALLY CLEAN ventilator breathing system
The SLE6000 ventilator is intended for use by a and accessories.
physician or authorised qualified medical personnel.
The ventilator is mobile when trolley mounted but
intended for static operation in a hospital intensive
care unit in normal use.

1.1.1 Medical indication


Any pathology, where optimal gas exchange is
compromised and/or where patient condition
necessitates respiratory support.

1.1.2 Medical contraindication


There are no known contra-indications to
ventilation. Cautions and warnings in this manual
should be adhered to.

1.1.3 Patient type


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

1.1.4 Body part under treatment


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

1.1.5 Clinical therapy


The SLE 6000 is used in conventional modes of
ventilation for:
- Non-life support ventilation and life support
ventilation (needs Vte or etCO2 measurement)
- Non-invasive and invasive ventilation
The SLE6000 with ‘HFOV’ option offers additional
high frequency oscillation (HFOV) modes.

1.1.6 Main User Profile


The SLE 6000 is intended to be used in clinical
application only by appropriately trained medical
personnel and operated only by trained technicians
during maintenance and service.

6
Warnings and cautions

Warnings and cautions


“Warnings - general” on page 8
“Cautions - general” on page 10

7
Warnings and cautions

2. Warnings & Cautions 15 The ventilator does not use Latex, nor was it
used in its construction.
2.1 Warnings - general
16 Disconnect the mains power supply from the
The following warnings must be read and ventilator prior to cleaning.
understood before using the ventilator. Failure to do
so could lead to injury or death of the patient. 17 Do not cover the ventilator during use or allow
the ventilator to become covered by any fabric or
1 The whole of this manual should be read and curtain. Do not allow the exhaust ports or inlet
understood before using the ventilator. vents to become obstructed or blocked by
Operators must be suitably trained and clinically positioning the ventilator near curtains or fabric.
authorized for using the ventilator with patients.
Particular care should be taken to check the 18 The ventilator has no emergency air intake.
ventilator pressures prior to changing modes. 19 In a “Mains Power Fail” condition and if the user
2 Oxygen - Clinical use. Oxygen is a drug and clears the “Mains Power Fail” alarm, the next
should be prescribed as such. power related alarm that will trigger will be the
medium priority “Battery Low” alarm. This
3 Oxygen - Fire Hazard. Oxygen vigorously indicates that the internal power supply has
supports combustion and its use requires special reached 25% capacity. If the user clears the
precaution to avoid fire hazards. Keep all medium priority “Mains Power Fail” alarm, the
sources of ignition away when oxygen is in use. next power related alarm that will trigger will be
Do not use oil or grease on oxygen fittings or the high priority “Battery Low” alarm. This
where oxygen is used. indicates that the internal power supply has a
less than 10 minutes remaining battery life.The
4 Check the condition of the gas supply hoses to
user shall remove the patient to an alternative
the ventilator. Do not use any hose that shows
form of ventilation at this point if mains power
signs of cracking, abrasion, kinking, splits,
cannot be restored.
excessive wear or ageing. Make sure that the Air
or O2 hose has not come into contact with oil or 20 When the ventilator is used without the flow
grease. sensor and ventilating a patient with a 3mm or
smaller size endotracheal tubes, in the case of
5 When the ventilator is being used on a patient, a
patient extubation or the ET tube disconnecting
suitably trained person must be in attendance at
from its ET connector, only the monitoring of
all times to take prompt action should an alarm
flow, or of SpO2, or of transcutaneous Oxygen
or other indication of a problem occur.
and Carbon Dioxide will dependably alert the
6 Do not enter the “Standby” mode when medical team to an alarm situation, not the
connected to a patient. No ventilation is monitoring of pressures.
delivered.
21 Failure to comply with the recommended service
7 In case of ventilator failure, the lack of immediate programs could lead to injury of the patient,
access to appropriate alternative means of operator or damage to the ventilator. It is the
ventilation can result in patient death. owners responsibility to ensure that the
equipment is regularly maintained.
8 Do not touch the patient and ventilator metalwork
at the same time to avoid earthing the patient. 22 To avoid the risk of electric shock, this equipment
must only be connected to a supply mains with
9 The ventilator shall not be used in a hyperbaric protective earth.
chamber.
23 The ventilator must not be started or used on
10 The ventilator shall not be used in a MRI battery power alone.
(Magnetic Resonance Imaging) scanner.
24 If the ventilator is adversely affected by
11 The ventilator shall not be used with helium or equipment emitting electromagnetic interference
mixtures with helium. then that equipment should be switched off or
12 The ventilator accuracy can be affected by the removed from the vicinity. Conversely, if the
gas added by use of a nebuliser. ventilator is the source of interference to other
neighbouring equipment, it should be switched
13 Any computer connected to the ventilator must off or taken to another location.
be specified for medical use.
14 The VGA port shall not be used when connected
to a patient. It is for training purposes only.

8
Warnings and cautions

25 The functioning of this machine may be 40 The patient circuit should not be modified other
adversely affected by the operation of equipment than the way described for non invasive use.
such as high frequency surgical (diathermy) Modified patient circuits or circuits with additional
equipment, defibrillators, mobile phones or short- sections or components may produce too high a
wave therapy equipment in the vicinity. circuit resistance and circuit compliance for
effective ventilation.
26 The equipment is not suitable for use with, or in
the presence of flammable anaesthetic mixtures. 41 Do not allow the heated section of the patient
circuit to come into contact with the patient.
27 Do not clean the touchscreen whilst the
ventilator is in operation. 42 Adding attachments or other components or sub-
assemblies to the ventilator breathing system
28 No modification of the ventilator is allowed. Any can change the pressure gradient across the
modification of the ventilator or system requires ventilator breathing system and that such
evaluation to BS EN 60601-1. (Please contact changes to the ventilator breathing system can
SLE if you require modification of the ventilator adversely affect the ventilator performance.
or the system).
43 Nebulisation or humidification can increase the
29 The ventilator shall only be used with SLE resistance of breathing system filters and that
approved accessories. the operator needs to monitor the breathing
30 The RS232 port shall not be connected to an IT system filter frequently for increased resistance
network. and blockage.

31 USB data devices shall not be connected to the 44 Do not allow heated section of the patient circuit
data port during patient use. to become covered, i.e. by a blanket or covering.

32 Only the Aerogen USB controller shall be 45 Do not touch the humidifier hot plate if exposed,
connected to the rear mounted USB port marked as it may burn the skin when hot.
Aerogen USB controller. 46 Ensure the temperature probes are cleaned and
33 Ensure that the ventilator is not positioned in sterilized as per the manufacturers instructions.
such a way that it is difficult to operate the
disconnection of the device.
2.3 Warnings - clinical
1 Failure to take corrective action when the alarms
34 When the air or oxygen supplies are known to are activated could result in injury or death to the
contain moisture and the ventilator is to be used patient.
continuously the user is required to check the
rear mounted water traps at regular intervals. 2 Use of the nurse call function does not remove
the need to monitor both the patient or ventilator
35 The user needs to be aware that SLE6000 at regular intervals.
ventilator alarms can be configured to user
defined presets. This can lead to units within a 2.3.1 Monitoring
single locale having different alarm presets. The minimum bedside patient monitoring
2.2 Warnings patient circuit & requirements are:
humidifier • ECG/heart rate.
36 Use only SLE approved patient circuits. The • Blood pressure.
accuracy of controlled and measured • Respiratory rate.
parameters is only guaranteed by use of the
• Oxygen saturation.
approved circuits.
If the bedside patient monitor cannot provide blood
37 On no account should antistatic or electrically pressure and oxygen saturation monitoring then
conductive tubing be used. independent blood pressure and oxygen saturation
38 The humidifier used in the patient circuit must be monitoring shall be used.
operated and maintained in accordance with the
manufacturer’s instructions.
39 Any water trap used in the patient circuit must be
held in the upright positions below the patient
and drained regularly before it is full.

9
Warnings and cautions

Additional monitoring HFO and non invasive 3 Do not use a sharp instrument, such as a pen to
ventilation activate the controls as the excessive pressure
applied by the point will damage the touchscreen
• Transcutaneous carbon dioxide monitoring. membrane.
Additional monitoring conventional invasive
modes 4 The ventilator contains temperature dependant
devices which perform normally in controlled
• Transcutaneous carbon dioxide monitoring or environments in hospitals. However if the
ETCO2 monitoring ventilator has been stored at a temperature
For units that are without Transcutaneous carbon different to that in which it will be used, allow the
dioxide monitoring or ETCO2 monitoring facilities for unit to acclimatize before powering up.
arterial / venous or capillary blood sampling must be (Operating temperature range +10ºC to +40ºC)
available. 5 Disposal of the Oxygen cell should be in
accordance with local regulations for hazardous
2.3.2 Clinical - invasive substances. Do not incinerate. SLE offers a cell
1 When switching from conventional to high- disposal service.
frequency ventilation, or vice-versa, alterations in
ventilator settings and inspired oxygen 6 Care should be taken when attaching other
concentrations may be required. equipment as this may affect mechanical
stability.
2 All ventilation should only be initiated by fully
trained and experienced medical personnel. 2.4.1 Flow sensor
3 Incorrect humidification; could cause 1 The reusable and single use flow sensor are
mobilisation of secretions and airway blockage. serviceable items and may require cleaning
during use.
4 Intra-ventricular haemorrhage, cerebral
ischaemia due to increased levels of carbon 2.5 Cautions - clinical
dioxide. 1 Avoid setting the alarm limits to their extreme
values as this can limit the ventilators ability to
5 Volutrauma resulting in (bronchopulmonary
detect hazardous conditions.
dysplasia in the newborn);
6 The use of an uncuffed ET tube causing leaks
preventing oxygenation and ventilation.
7 Maintenance of an adequate airway is of
paramount importance.

2.3.3 Clinical - non invasive


1 Damage to nares.
2 Under- or over- ventilatory support (with
consequent abnormalities in blood gases);
3 Incorrect humidification; could cause
mobilisation of secretions and airway blockage.
4 Damage to trachea and bronchi;
5 Over- or under- inflation of the lung;
6 Atalectasis;
7 Air leak syndrome (pneumothorax,
pneumomediastinum, pneumopericardium.
pulmonary interstitial emphysema).

2.4 Cautions - general


1 The ventilator should be disposed of in
accordance to the local WEEE (Waste Electrical
and Electronic Equipment) guidelines.
2 Do not use solvent based cleaning solutions to
clean the touchscreen or covers.

10
Contents

Contents 4.9.4 Pre-functional test checks ....................... 25


4.9.5 Functional testing (Invasive dual limb) .... 25
1. Intended use of the SLE 6000 ....... 6 4.9.6 Functional testing (Non invasive dual
limb).................................................................. 26
1.1 Summary statement ................................... 6
4.9.7 Functional testing (Non invasive single
1.1.1 Medical indication.................................... 6
limb).................................................................. 26
1.1.2 Medical contraindication.......................... 6
4.10 Turning the ventilator Off ......................... 27
1.1.3 Patient type ............................................. 6
4.10.1 Isolation from mains supply................... 27
1.1.4 Body part under treatment ...................... 6
1.1.5 Clinical therapy........................................ 6
5. Patient circuit selection ................ 30
1.1.6 Main User Profile..................................... 6
1.2 Condition of use ......................................... 6 5.1 Type of ventilation ...................................... 30
5.1.1 Invasive ................................................... 30
2. Warnings & Cautions ....................8 5.1.2 Non-Invasive (Dual limb) ......................... 30
5.1.3 Non-Invasive (Single limb) ...................... 30
2.1 Warnings - general ..................................... 8
5.1.3.1 Patient circuit selection......................... 30
2.2 Warnings patient circuit & humidifier .......... 9
5.2 Assembly of BC6188 (Ø10 mm) or BC6198
2.3 Warnings - clinical ...................................... 9
(Ø15 mm) patient circuit ................................... 30
2.3.1 Monitoring ............................................... 9
5.2.1 Bacterial filters......................................... 30
2.3.2 Clinical - invasive .................................... 10
5.2.2 Humidification chamber........................... 30
2.3.3 Clinical - non invasive ............................. 10
5.2.3 Fitting the temperature probes to a
2.4 Cautions - general...................................... 10
BC6188 patient circuit ...................................... 32
2.4.1 Flow sensor............................................. 10
5.2.4 Fitting the temperature probes to a
2.5 Cautions - clinical ....................................... 10
BC6198 patient circuit ...................................... 32
5.2.5 Fitting the flow sensor to a BC6188
3. Ventilator layout ............................18 patient circuit .................................................... 33
3.1 Front........................................................... 18 5.2.6 Fitting the flow sensor to a BC6198
3.2 Rear ........................................................... 19 patient circuit .................................................... 33
5.2.7 Fitting the test lung .................................. 33
4. Ventilator basic setup ...................22 5.3 Assembly of BC6188/DHW patient circuit .. 34
4.1 Pre-use Inspection ..................................... 22 5.3.1 Bacterial filters......................................... 34
4.2 Connection of equipotential bonding cable 22 5.3.2 Humidification chamber........................... 34
4.3 Connection of mains power........................ 22 5.3.3 Fitting the test lung .................................. 36
4.3.1 IEC/BS 1363/A3 specification power 5.4 Modification of BC6188 or BC6188/DHW
leads................................................................. 22 circuits for non-invasive dual limb ventilation. .. 37
4.3.2 Schuko and NEMA specification power 5.4.1 Fitting a dual limb nCPAP generator........ 37
leads................................................................. 22 5.5 Modification of BC6188 or BC6188/DHW
4.4 Connection of 24V DC power..................... 22 circuits for non-invasive single limb ventilation. 38
4.4.1 Mains or DC power supply - power 5.5.1 Bacterial filters......................................... 38
switch status indicator ...................................... 23 5.5.2 Humidification chamber........................... 38
4.5 Fitting the silencer and exhalation block .... 23 5.5.3 Fitting the temperature probes ................ 39
4.6 Gas connections ........................................ 23 5.5.4 Fitting a single limb nCPAP generator. .... 40
4.7 Ventilator - patient & operator position ....... 23 5.6 Modification of BC6188 or BC6188/DHW
4.8 Turning the ventilator On............................ 24 circuits for non-invasive single limb O2
4.8.1 With mains connected............................. 24 therapy.............................................................. 41
4.8.2 Without mains connected........................ 24 5.6.1 Bacterial filters......................................... 41
4.8.3 With DC power connected ...................... 24 5.6.2 Humidification chamber........................... 41
4.9 Pre-use functional test ............................... 24 5.6.3 Fitting the temperature probes ................ 42
4.9.1 Power on self test.................................... 24 5.6.4 Fitting a oxygen therapy nasal cannula... 43
4.9.2 Reserve power check.............................. 24
4.9.3 Patient circuit selection ........................... 25

11
Contents

6. Ventilation - Invasive ....................46 9.4.2 Alarm thresholds for Oscillatory modes


6.1 CPAP.......................................................... 46 (invasive and non invasive - dual limb). ........... 77
9.4.2.1 HFOV & NHFOV .................................. 77
6.2 CMV ........................................................... 48
9.4.2.2 HFO+CMV (invasive - dual limb).......... 78
6.3 PTV ............................................................ 50
9.4.3 Alarm thresholds for conventional modes
6.4 PSV ............................................................ 52
(non invasive - single limb)............................... 79
6.5 SIMV .......................................................... 54
9.5 Patient Circuits, Humidification and Nitric
6.6 HFOV ......................................................... 56
Oxide Therapy.................................................. 79
6.7 HFOV+CMV ............................................... 58
9.5.1 Autofeed Humidification chambers.......... 79
6.8 Common warnings ..................................... 60
9.5.2 Nitric Oxide Therapy................................ 80
6.9 Common cautions ...................................... 60
9.5.3 Nebulization of Medication ..................... 80
6.9.1 Common alternate functions 9.5.3.1 Pneumatically driven. ........................... 80
(Conventional ventilation)................................. 60 9.5.3.2 Nebulization Procedure ........................ 81
6.9.1.1 Manual breath or Inspiratory hold ........ 60 9.5.3.3 Nebulization using Aerogen® ............... 81
6.9.1.2 O2 Boost or O2 suction......................... 60
6.9.2 Common alternate functions (High 10. User interface description .......... 84
frequency ventilation) ....................................... 60
6.9.2.1 Sigh or Sigh hold.................................. 60 10.1 Standby mode .......................................... 84
6.9.2.2 O2 Boost or O2 suction......................... 60 10.1.1 User interface ........................................ 84
6.10 Ventilation without a flow sensor .............. 60 10.1.2 Information panel................................... 84
10.1.3 Information bar ...................................... 84
7. Non-invasive - Dual limb .............. 62 10.1.4 Generic button/panel functions.............. 84
10.1.4.1 Panel functions................................... 84
7.1 nCPAP D .................................................... 62 10.1.4.2 Parameter time out............................. 84
7.2 NIPPV D..................................................... 64 10.1.4.3 Panel time out .................................... 84
7.3 nHFOV D.................................................... 66 10.1.4.4 Button states ...................................... 84
10.1.4.5 Mode button ....................................... 84
8. Non-invasive - Single limb ...........68 10.1.4.6 Start/Resume Ventilation button ......... 84
10.1.4.7 Alarms ................................................ 84
8.1 nCPAP S .................................................... 68 10.1.4.8 Utilities button..................................... 84
8.2 O2 therapy ................................................. 70 10.1.4.9 Calibration & Utilities button ............... 85
8.3 Common warnings ..................................... 71 10.1.4.10 Layout button.................................... 85
8.4 Common cautions ...................................... 71 10.1.4.11 Multi function button ......................... 85
8.5 Common note............................................. 71 10.1.5 Mode button & Start/Resume
Ventilation button ............................................. 85
9. Operational features ..................... 74 10.1.6 Alarm button ......................................... 85
10.1.6.1 Limits tab ........................................... 85
9.1 General ...................................................... 74 10.1.6.2 History tab ......................................... 86
9.1.1 Standby Mode ......................................... 74 10.1.6.3 Loudness tab...................................... 86
9.1.2 Apnoea alarm set to “Off”........................ 74 10.1.7 Utilities & Calibration & Utilities button .. 86
9.1.3 Reserve power source ............................ 74 10.1.7.1 Sensors tab ........................................ 87
9.1.4 Parameter Memory ................................. 74 10.1.7.2 Brightness tab .................................... 87
10.1.7.3 System Tab......................................... 87
9.1.5 HFO variable I:E ratio (Only available
10.1.7.4 Data tab.............................................. 89
with HFO and NHFOV options)........................ 74 10.1.7.5 Downloading screen captures ............ 89
9.1.6 Trigger sensitivity .................................... 75 10.1.8 Layout Tab............................................. 90
9.1.7 Volume Targeted Ventilation, Vte (VTV).. 75 10.1.8.1 Waveforms ......................................... 91
9.1.7.1 Ti .......................................................... 75 10.1.8.2 Loops.................................................. 91
9.1.7.2 Vte Target Resolution........................... 75 10.1.8.3 Trends ................................................ 92
9.1.8 Max Ti in PSV ......................................... 75 10.1.8.4 Single & double trend display............. 93
9.1.9 Suctioning (Closed suction). ................... 75 10.1.8.5 Viewing trends.................................... 93
9.2 O2 Suction ................................................. 75 10.2 Ventilation mode....................................... 95
9.3 O2 Boost .................................................... 76 10.2.1 Alarm mute and pre-mute button........... 95
9.4 Alarm thresholds ........................................ 77 10.2.2 Parameters............................................ 95
9.4.1 Alarm thresholds for conventional 10.2.2.1 Parameter types ................................ 95
10.2.2.2 Parameter states ................................ 95
modes (invasive and non invasive - dual limb). 77

12
Contents

10.2.2.3 Modifying a parameter ....................... 95 14. Oxygen Calibration Routines ..... 105
10.2.2.4 Turning “ON” a parameter function .... 95
14.1 One Point O2 Calibration.......................... 105
10.2.3 Preview mode ....................................... 96
14.2 Two Point O2 Calibration .......................... 105
10.2.4 Patient circuit selection ......................... 96
10.2.5 Monitored values................................... 96
10.2.5.1 Single column/double column layout.. 96 15. N5402-REV2 & N5302 flow sensor
10.2.6 Alarms tab - ventilatory mode ............... 97 106
10.2.6.1 Adjusting an alarm threshold.............. 97 15.1 Calibration of the Flow Sensor ................. 106
10.2.6.2 Alarm auto tracking/auto set 15.2 Cleaning and high level disinfection of the
thresholds......................................................... 97
N5402-REV2 Sensor........................................ 107
10.2.7 History and Loudness ........................... 98
15.2.1 Cleaning: ............................................... 107
10.2.8 Utilities tab - ventilatory mode ............... 98
15.2.2 Disinfection:........................................... 107
10.2.8.1 Flow sensor calibration ...................... 98
10.2.8.2 O2 calibration ..................................... 99 15.2.3 High level disinfection............................ 107
10.2.9 Brightness tab - ventilatory mode.......... 99
10.2.10 System tab - ventilatory mode............. 99 16. Technical specification .............. 108
10.2.11 Data tab - ventilatory mode ................. 99 16.1 Operating Modes - Conventional Invasive
10.2.12 Layout ................................................. 99 Ventilation ........................................................ 108
10.2.13 Lock screen button.............................. 99 16.1.1 CPAP mode ........................................... 108
10.2.14 Pause/play .......................................... 99 16.1.2 CMV mode ............................................ 108
10.2.15 Screen capture.................................... 99 16.1.3 PTV mode ............................................. 109
10.2.16 Alarm bar............................................. 100 16.1.4 PSV mode ............................................. 109
10.2.17 Mode specific controls......................... 100 16.1.5 SIMV mode............................................ 110
10.2.17.1 Manual breath (Inspiratory Hold)...... 100 16.1.6 HFOV mode ......................................... 110
10.2.17.2 Sigh (Sigh Hold) ............................... 100 16.1.7 HFOV+CMV mode ................................ 111
10.2.18 Oscillation Pause ................................ 100 16.2 Operating Modes Conventional Non
10.2.19 HFO Activity ........................................ 100 Invasive Ventilation .......................................... 111
16.2.1 nCPAP D mode (Dual Limb).................. 111
11. Technical description .................102 16.2.2 NIPPV D mode (Dual Limb) .................. 112
16.2.3 nHFOV D mode (Dual Limb) ................. 112
12. Description of ventilatory modes 16.2.4 nCPAP S mode (Single Limb) ............... 113
(Invasive) ............................................103 16.2.5 O2 therapy (Single Limb) ...................... 113
12.1 CPAP........................................................ 103 16.3 Mode of operation .................................... 113
12.2 CMV ......................................................... 103 16.4 Controls .................................................... 113
12.2.1 CMV & VTV........................................... 103 16.4.1 Power Button ........................................ 113
12.3 PTV .......................................................... 103 16.4.2 User Interface........................................ 113
12.3.1 PTV & VTV........................................... 103 16.4.2.1 Buttons .............................................. 113
12.4 PSV .......................................................... 103 16.4.2.2 Tabs.................................................... 116
16.4.2.3 Controls ............................................. 116
12.4.1 PSV & VTV............................................ 103
16.5 Measurement .......................................... 118
12.5 SIMV ........................................................ 103
16.5.1 Flow sensor ........................................... 118
12.5.1 SIMV with P Support ............................. 104
16.5.2 Flow ...................................................... 118
12.5.2 SIMV & VTV .......................................... 104
16.5.3 Volume .................................................. 118
12.6 HFO.......................................................... 104
16.5.4 Volume controlled breath accuracy ....... 118
12.7 HFO+CMV................................................ 104
16.5.5 Pressure controlled breath accuracy..... 118
16.5.6 Measured parameters ........................... 118
13. Description of ventilatory modes
16.5.6.1 Oxygen Concentration ....................... 119
(Non-invasive) ...................................104 16.5.6.2 Pressure ............................................ 119
13.1 nCPAP (Dual and Single limb) ................. 104 16.5.6.3 Sound pressure level.......................... 119
13.2 NIPPV (Dual limb) .................................... 104 16.5.6.4 Exhalation Block Port Jet Sizes ......... 119
13.3 nHFO (Dual limb only).............................. 104 16.5.7 BS EN ISO 80601-2-12 Disclosure ....... 120
13.4 O2 Therapy (Single limb only) .................. 104 16.5.8 Measurement uncertainties ................... 120
16.6 Patient circuits .......................................... 120

13
Contents

16.7 Breathing system filters ........................... 120 19.4 Hardware Fault 4. (Monitor memory fault
16.7.1 N3029.................................................... 120 table) ................................................................ 154
16.7.2 N3587.................................................... 120 19.5 Hardware Fault 6. (Controller fault table) . 155
16.8 Maximum limited Pressures ..................... 120 19.6 Hardware Fault 5 & 9. (Local voltage
16.9 Gas supplies ........................................... 121 monitor fail fault table) ...................................... 156
16.9.1 Oxygen supply ..................................... 121
16.9.2 Air supply ............................................. 121 20. Cleaning and disinfection .......... 157
16.9.2.1 Connectors ........................................ 121
20.1 Instructions ............................................... 157
16.9.3 Flows .................................................... 121
20.2 External surface cleaning instructions...... 157
16.10 Service life.............................................. 121
20.3 External surface disinfection instructions . 158
16.11 Power, Dimensions, Classification ......... 121
20.4 Exhalation block cleaning instructions...... 158
16.11.1 Power AC ............................................ 121
20.5 Exhalation block disinfection instructions . 158
16.11.2 Power DC ............................................ 121
20.6 Silencer disinfection instructions .............. 158
16.12 Operating Environment .......................... 121
20.7 Gas jet ports disinfection .......................... 158
16.12.1 Connectors ......................................... 121
20.8 Occlusion valve ........................................ 158
16.13 Classification (Electrical) ........................ 122
20.9 Cleaning of main air intake filter. .............. 158
16.14 GMDN classification number.................. 122
16.15 IP rating.................................................. 122
21. Troubleshooting Chart ............... 159
16.16 Environmental Storage Conditions......... 122
21.1 Ventilation Related Problems ................... 159
17. Outputs ports (Electrical) ...........122 21.2 Ventilator Related Problems..................... 161

17.1 RS232 port ............................................... 122


22. Planned preventative Maintenance
17.1.1 SLE6000 basic data output. .................. 122
(PPM) .................................................. 165
17.1.2 SLE6000 basic data output
Specifications ................................................... 122 22.1 PPM schedule .......................................... 165
17.1.3 Communications Settings ..................... 122 22.2 PPM kits ................................................... 165
17.1.3.1 Data Rate & Size................................ 122 22.2.1 Kit A....................................................... 165
17.1.3.2 Data Format ....................................... 123 22.2.2 Kit B....................................................... 165
17.1.4 Data Layout........................................... 123 22.3 Kit part numbers ....................................... 165
17.1.5 Data Format .......................................... 123 22.4 Mains cable replacement ......................... 165
17.2 Nurse call ................................................. 127
17.2.1 Nurse call delay..................................... 127 23. Functional testing ....................... 166
17.3 Ethernet.................................................... 127 23.1 Alarm testing ............................................ 166
17.4 USB (Data)............................................... 127 23.1.1 High Oxygen/Low Oxygen/Loss of gas
17.5 USB (Power) ............................................ 127 supply alarm test .............................................. 166
17.6 External Monitor ....................................... 127 23.1.2 Obstruction alarm - Blocked fresh gas .. 166
23.1.3 Partial occlusion alarm - Continuing
18. Inputs ports (Electrical) .............. 128 positive pressure .............................................. 166
18.1 SPO2 and EtCO2...................................... 128 23.1.4 High Pressure alarm - High pressure
18.2 Flow sensor.............................................. 128 threshold exceeded .......................................... 166
18.3 DC 24V..................................................... 128 23.1.5 Expired volume alarm - Tidal volume
above/below threshold ..................................... 167
19. Alarms .......................................... 129 23.1.6 Volume alarm - Minute volume
19.1 Alarm Prioritization ................................... 129 above/below threshold ..................................... 167
19.1.1 Alarm Characteristics ............................ 129 23.1.7 Power supply failure alarm - Main
19.1.2 Alarm sounder volume .......................... 129 power fail and battery check............................. 167
19.1.3 Alarm log ............................................... 129 23.2 Performance testing. ................................ 167
19.2 Alarm Indicators characteristics ............... 129 23.2.1 Conventional ......................................... 167
19.2.0.1 Alarm table ......................................... 131 23.2.2 Oscillatory.............................................. 167
19.3 Hardware Fault 3. (Power supply fault
table) ................................................................ 154

14
Contents

24. EMC compliance .........................169 29.7.2 Debug log .............................................. 192


24.1 Electromagnetic immunity ........................ 170
24.2 Recommended separation distances. ...... 172 30. Training (User) ............................ 193

25. Pneumatic unit diagram .............173 31. Training (service) ........................ 193
25.1 Patient circuit pneumatic diagrams .......... 174
32. Accessories ................................. 196
26. Software version identification ..175 33. Glossary ............................................... 199
27. Installation instructions ..............178 34. SLE6000 markings and symbols 201
27.0.1 Tools required for trolley assembly........ 178
34.1 Description of ventilator markings ............ 201
27.1 Unpacking. ............................................... 178
34.2 Description of interface markings. ............ 202
27.2 Medicart assembly ................................... 179
27.2.1 Medicart kit contents ............................. 179
27.2.2 Assembly............................................... 179
27.3 Ventilator unpacking ................................. 180
27.4 Ventilator lifting points .............................. 181
27.5 Ventilator assembly to Medicart ............... 181
27.6 Mains cable attachment ........................... 181
27.7 Pre-use functional test. ............................ 182
27.8 Ventilator configuration............................. 182

28. User preferences .........................184


28.1 Accessing user preferences..................... 184
28.1.1 Parameters tab...................................... 184
28.1.1.1 Parameters......................................... 184
28.1.2 Ventilation tab........................................ 185
28.1.3 Alarms tab ............................................. 185
28.1.4 Interface tab .......................................... 185
28.1.5 Regional tab .......................................... 186
28.1.6 Save / Quit tab ...................................... 186

29. SLE 6000 Event and patient log


software .............................................188
29.1 Minimum system requirements ................ 188
29.1.1 Memory stick requirements ................... 188
29.2 Installation of software.............................. 188
29.3 Downloading the Patient log or Event log 188
29.4 Export file formats .................................... 189
29.4.1 File types............................................... 189
29.4.1.1 RealtimeLog ....................................... 189
29.4.1.2 AlarmsLog .......................................... 189
29.4.1.3 TrendsDataLog................................... 189
29.4.1.4 SystemLog ......................................... 189
29.4.1.5 DebugLog........................................... 189
29.4.1.6 Log records ........................................ 189
29.5 Reading patient Log files (.dat) ................ 190
29.6 Reading Patient Log files (.txt) ................. 191
29.7 Reading Event Log files (.evt) .................. 191
29.7.1 Event log ............................................... 191

15
Contents

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16
Ventilator layout

Ventilator layout

17
Ventilator layout

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

10

1
5

4 3 2

9
8

3.1 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

18
Ventilator layout

11
30 29

28 27

25 26 12

24 23

20 13

15 14
22 21
19

17
16
18

3.2 Rear 24 EtCO2 electrical connector


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

19
Ventilator layout

31

32

33

36 34

35

31 Air vent (Exhaust)


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

20
Ventilator setup

Ventilator setup

“Pre-use Inspection” on page 22


“Connection of equipotential bonding cable” on page 22
“Connection of mains power” on page 22
“Connection of 24V DC power” on page 22
“Fitting the silencer and exhalation block” on page 23
“Gas connections” on page 23
“Turning the ventilator On” on page 24

21
Ventilator setup

4. Ventilator basic setup 4.3 Connection of mains power


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

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


Note: If the filter is dirty please follow the
cleaning procedure in the maintenance
section on page 157.

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.
4.2 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
4.3.2 Schuko and NEMA specification power
non-current carrying metalwork to form a
leads
zone within which it is not possible for
exposed metalwork to be at different voltage Insert the mains plug into
levels, which could cause a shock i.e. to the mains socket.
create an earthed equipotential zone).

The ventilator is equipped with one rear mounted


bonding point.

Connect the equipotential


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

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

bonding point (4).


Caution: Use only a medical grade 24V DC


power supply with a current rating of 4 A.

22
Ventilator setup

Fit the assembly to the


Note: The mains cable does not have to be
gas ports and lock in
disconnected when using the 24V DC power.
place.
4.4.1 Mains or DC power supply - power switch Note: The user will
status indicator be unable to close
When mains or DC power is not the access cover
connected to the ventilator the halo unless the exhalation
indicator around the mains switch will block is locked in
be off. place.

When mains power or DC is Close the access cover.


connected to a ventilator that is "OFF"
the halo indicator around the mains 4.6 Gas connections
switch will illuminate. A static halo
shows that the internal batteries are Warning. Check the condition of the gas
fully charged. supply hoses to the ventilator. Do not use any
hose that shows signs of cracking, abrasion,
A flashing halo shows that the internal kinking, splits, excessive wear or ageing.
batteries are partially or fully dis- Make sure that the Air or O2 hose has not
charged and they are charging. come into contact with oil or grease.

Connect the Air and


Oxygen hoses to the rear
4.5 Fitting the silencer and exhalation of the ventilator.
block
Open the exhalation Ensure the connecting
block access cover. nuts are hand tight.

Note: NIST connectors shown.

Connect the probes to


the wall connections
Clean the gas ports with
an alcohol wipe.

Note: BS probes shown.


Connect the Silencer and
exhalation block
together.
The relief valve balls 4.7 Ventilator - patient & operator
 

indicate the rear of the position


exhalation block. In a standard setup the ventilator should be placed
to one side of the head end of the incubator/cot.
The operator position is standing in front of the
Note: Ensure that the silencer and Exhalation ventilator.
block have been cleaned in accordance with Routing of the patient circuit is left to the discretion
the Cleaning and disinfection instructions on of the user.
page 157.
Warning. Ensure that the water trap is always
situated below the patient.

23
Ventilator setup

4.8 Turning the ventilator On 4.9 Pre-use functional test


4.8.1 With mains connected 4.9.1 Power on self test
Push and hold the mains switch for 3 Each time the ventilator is turned on it will perform a
seconds. power on self test (POST).
The POST checks the pneumatic unit for correct
The halo light should be amber (static function. Any issues will be shown by the machine
or flashing). displaying a technical alarm.
The ventilator also activates the visual and audible
The halo light should change colour to components of the alarm system.
green.
The ventilator will now power up and 1 Turn the unit on
enter standby mode.
2 Verify that the alarm light bar cycles Red,
Amber & Cyan.
The battery icon will be accompanied
by the mains power icon to show that 3 Verify that a single high priority audible alarm
the ventilator is running on mains was sounded.
power.
4.9.2 Reserve power check
4.8.2 Without mains connected Look at the battery status icon to see
Push and hold the mains switch for 3 the charge status of the reserve power
seconds. source.
The capacity is rated in a percentage
The halo light should be off. from 100% fully charged to 0% complete discharge.
If using the ventilator without the mains supply or
The halo light should change colour to the 24V DC supply the following is a guide to the
green. approximate operating time on the internal battery.
The ventilator will now power up and The ventilator will typically run for over 3 hours from
enter standby mode. 100% battery charge to complete discharge, both in
conventional and HFO modes. Actual battery
The battery icon only will appear to discharge duration will depend on battery condition
show that the unit is running on battery and ventilation settings applied. Please refer to the
power. warning for actual safe operation times.

Note: After the unit enters Standby mode the


user will have to acknowledge the Mains Mode 100% to 25% 50% to 25%
power fail alarm message once the Calibrate Standby 130 40
flow sensor/Flow sensor not connected
alarms is cleared. CMV 120 35

HFO+CMV 105 30
4.8.3 With DC power connected
Push and hold the mains switch for 3 NIPPV 120 35
seconds. All times are in minutes.

The halo light should be amber (static


Note: The above stated times can vary due to
or flashing).
the age or condition of the batteries.
The halo light should change colour to
green.
The ventilator will now power up and Warning. When the ventilator internal power
enter standby mode. source reaches 25% the user is required to
transfer the patient to an alternate form of
The DC power icon will appear to ventilation if re-connection to the mains
show that the unit is running on 24V supply is not possible. At 25% the ventilator
DC power. will display and sound the “Battery Low”
alarm.

24
Ventilator setup

4.9.3 Patient circuit selection 10 Ensure that the “No Air Supply” alarm is
1 To carry out the patient circuit setup, as per triggered.
chapter ’5. Patient circuit selection’ on page 11 Disconnect the Oxygen supply.
30.
12 Ensure that the “No Gas” alarm is triggered.
2 When the patient circuit has been assembled
13 Re-connect the Air supply.
continue with one of the following tests
14 Reset the low PIP alarm message.
• Invasive test section ’4.9.5 Functional testing
(Invasive dual limb)’ on page 25. 15 Ensure that the “No Oxygen Supply” alarm is
• Non invasive test dual limb section ’4.9.6 triggered.
Functional testing (Non invasive dual limb)’ on 16 Reconnect the oxygen supply.
page 26.
17 Ensure all alarms cancel.
• Non invasive test single limb section ’4.9.7
Functional testing (Non invasive single limb)’ 18 Select and enter HFO mode.
on page 26. 19 Set a Delta P of 10 mbar.

4.9.4 Pre-functional test checks 20 Ensure that the ventilator is oscillating and that
no alarms are present.
• Check that the humidifier is turned on. (Refer
to the manufacturers instructions for more 21 Ensure that the set MAP and measured MAP
details). are within 1 mbar.
• Check that the humidification chamber is filled
Note: If the reading for step 21 is outside the
with appropriate sterile water to the designated
stated tolerance check the patient circuit then
level.
re-check.
• Check that the patient circuit heating connector
is connected to the humidifier securely. (Refer 22 Remove the Fresh Gas limb.
to the manufacturers instructions for more
details). 23 Ensure that the “Leaking Fresh gas” alarm is
triggered.
• Check the patient circuit, make sure all the
connections are secure and that the water trap 24 Block the fresh gas port.
is empty and positioned upright. 25 Ensure that the “Blocked Fresh gas” alarm is
• Check that the humidifier temperature probes triggered.
are correctly inserted into the patient circuit 26 Refit the Fresh Gas limb. Check that all the
monitoring ports. alarms clear.
4.9.5 Functional testing (Invasive dual limb) 27 Reconnect the flow sensor and flow sensor
1 Remove the flow sensor and test lung. cable.
2 Occlude the ET manifold. 28 Calibrate the flow sensor.

3 Select and enter CMV mode. 29 Wait for the text “Calibration completed” to
appear.
Note: If a 15 mm circuit is fitted select the 15 30 Refit the flow sensor and test lung.
mm patient circuit setting.
31 Disconnect the mains power supply.
4 Press “Continue without flow sensor” 32 Ensure that the “Mains Power Fail” alarm is
5 Set the low PEEP alarm threshold to -1 mbar. triggered. Check that the mains power symbol
disappears.
6 Ensure that the ventilator is cycling and that no
alarms are present. 33 Re-connect the mains power supply.
7 Ensure that the set PIP and measured PIP are 34 Ensure that the “Mains Power Fail” alarm
within 1 mbar. cancels. Check that the mains power symbol
reappears.
8 Ensure that the set PEEP and measured
PEEP are within 1 mbar. 35 Return to standby mode
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.

9 Disconnect the Air supply.

25
Ventilator setup

4.9.6 Functional testing (Non invasive dual limb) 24 Disconnect the mains power supply.

Note: The non invasive ventilation does not 25 Ensure that the “Mains Power Fail” alarm is
require the use of the flow sensor. If the flow triggered. Check that the mains power symbol
sensor or flow sensor cable is connected disappears.
please disconnect prior to commencing the 26 Re-connect the mains power supply.
functional test.
27 Ensure that the “Mains Power Fail” alarm
1 Select and enter NIPPV D - dual limb mode. cancels. Check that the mains power symbol
reappears.
2 Occlude the prongs.
28 Return to standby mode
3 Set the low PEEP alarm threshold to -1 mbar.
29 Functional testing is now complete.
4 Ensure that the ventilator is cycling and that no
alarms are present. 4.9.7 Functional testing (Non invasive single
5 Ensure that the set PIP and measured PIP are limb)
within 1 mbar. Note: The non invasive ventilation does not
6 Ensure that the set PEEP and measured require the use of the flow sensor. If the flow
PEEP are within 1 mbar. sensor or flow sensor cable is connected
please disconnect prior to commencing the
Note: If the readings for step 5 & 6 are outside functional test.
the stated tolerance check the patient circuit
then re-check. 1 Select and enter nCPAP single limb mode.
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
triggered. 4 Ensure that the set CPAP and measured
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
11 Re-connect the Air supply.
triggered.
12 Reset the low PIP alarm message. 7 Disconnect the Oxygen supply.
13 Ensure that the “No Oxygen Supply” alarm is 8 Ensure that the “No Gas” alarm is triggered.
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
16 Remove the Fresh Gas limb. triggered.
17 Ensure that the “Leaking Fresh gas” alarm is
12 Reconnect the oxygen supply.
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
triggered. 15 Ensure that the “low pressure” alarm is
triggered.
20 Refit the Fresh Gas limb. Check that all the
alarms clear. 16 Block the fresh gas port.
21 Select and enter NHFOV - dual limb mode. 17 Ensure that the “Blocked Fresh gas” alarm is
triggered.
22 Set a Delta P of 10 mbar.
23 Ensure that the ventilator is oscillating and that
no alarms are present.Ensure that the set MAP
and measured MAP are within 1 mbar.

Note: If the reading for step 23 is outside the


stated tolerance check the patient circuit then
re-check.

26
Ventilator setup

18 Refit the Fresh Gas limb. Check that all the 4.10 Turning the ventilator Off
alarms clear.
On completion of the session the user should enter
19 Disconnect the mains power supply. standby mode.
20 Ensure that the “Mains Power Fail” alarm is Press and hold the power button for 2
triggered. Check that the mains power symbol seconds.
disappears.
21 Re-connect the mains power supply.
22 Ensure that the “Mains Power Fail” alarm The information panel will be replaced by the
cancels. Check that the mains power symbol shutdown dialog box and button.
reappears.
23 Return to standby mode
24 Functional testing is now complete.

Note: The shutdown dialog box will time out


after 10 seconds if no action is taken.

The user will have to repress the power switch


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

4.10.1 Isolation from mains supply


To isolate the ventilator from the mains supply
remove the mains plug.

Warning: Ensure that the ventilator is not


positioned in such a way that it is difficult to
operate the disconnection of the device.

27
Ventilator setup

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28
Patient circuits

Patient circuit selection


See “Assembly of BC6188 (Ø10 mm) or BC6198 (Ø15 mm) patient
circuit” on page 30.
See “Assembly of BC6188/DHW patient circuit” on page 34.
See “Modification of BC6188 or BC6188/DHW circuits for non-
invasive dual limb ventilation.” on page 37.
See “Modification of BC6188 or BC6188/DHW circuits for non-
invasive single limb ventilation.” on page 38.

29
Patient circuits

5. Patient circuit selection 5.2 Assembly of BC6188 (Ø10 mm) or


The SLE6000 has three patient circuits that are BC6198 (Ø15 mm) patient circuit
approved for use. The following instruction covers the assembly of the
Ø10 mm BC6188 patient circuit (Neonatal) and the
Ø15 mm BC6198 patient circuit (Paediatric). Both
BC6188 Single use Neonatal/Infant breathing circuit are single heated limb circuits.
– 10mm tubing, single heated wire.
5.2.1 Bacterial filters
BC6188/DHW Single use Neonatal/Infant breathing
Note: It is recommended that bacterial filters
circuit – 10/15mm tubing, dual heated wire.
are fitted in the fresh gas supply and on the
patient side of the exhalation block.
BC6198 Single use Paediatric breathing circuit –
15mm tubing. 1 Fit the single use bacterial filter (A) to the
exhalation port from patient port.
5.1 Type of ventilation 2 Fit the fresh gas port bacterial filter
(autoclavable) (B) to the fresh gas to patient port.
5.1.1 Invasive

For patients requiring tidal volumes of less than


50 ml use either:
BC6188
BC6188/DHW
For patients requiring tidal volumes of greater than B


50 ml use:
BC6198

5.1.2 Non-Invasive (Dual limb)


Use either:
A

BC6188
BC6188/DHW
Please refer to the consumable catalogue or the
See “Modification of BC6188 or BC6188/DHW SLE website for part numbers.
circuits for non-invasive dual limb ventilation.” on
page 37. 5.2.2 Humidification chamber
Ensure that the chamber is fitted securely to the
5.1.3 Non-Invasive (Single limb) humidifier and filled to the correct level with sterile
Use water..
BC6188.
BC6188/DHW

5.1.3.1 Patient circuit selection


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

Note: The selection of 15mm


patient circuits is only available
for invasive ventilation. 15mm
Changing to non-invasive Note: These instructions are illustrated with a
ventilation automatically standard single use humidification chamber.
selects 10mm patient circuits.
Auto fill and reusable chambers can also be
used. Reusable chambers will require the use
of an adaptor for the fresh gas supply.

30
Patient circuits

5 Connect the heated limb (H) to the free port of


Note: Please refer to the humidifier user
the humidification chamber (I).
manual for warnings, cautions and operating
instructions.
Please refer to patient circuit instructions for H
use for warnings and cautions and operating
instructions. 
1 Remove the patient circuit from protective bag.
I


Note: The BC6188 circuit is not supplied with
a humidification chamber (G).

2 Connect the 15mm female end (C) of the fresh


gas supply line (D) to the to the bacterial filter
fitted to the ventilator port marked “Fresh Gas to
Patient” (E).
6 Connect the exhalation limb (J) to the bacterial
E filter fitted to the exhalation port (K) marked

“Exhalation port from Patient”.


C

K


D J

F

Warning. Ensure that the water trap is always


situated lower than the patient.

7 Connect the proximal airway line (L) to the


3 Connect the free end (F) of the fresh gas supply proximal airway port (M) marked “Proximal
line (D) to one of the ports of the humidification Airway”.
chamber (G).
M
L

4 The remaining section of the circuit is supplied


assembled.

31
Patient circuits

5.2.3 Fitting the temperature probes to a 13 Connect the heater wire (Q) and the temperature
BC6188 patient circuit probes (R) to the humidifier.
8 Connect the humidifier temperature probes to
ports (N & O).

O
 R
 
Q
N
14 Connect the flow sensor cable (S) to the
9 Ensure the clip (P) is placed over the electrical connector on the front of the ventilator
temperature probe to ensure correct orientation. marked “Flow sensor” (T).

P T


S
5.2.4 Fitting the temperature probes to a
BC6198 patient circuit
10 Connect the humidifier temperature probes to
ports (N & O). 15 Connect the flow
sensor cable to the
flow sensor. Ensure
that the cable
O connector key fits into


N the rear notch of the

flow sensor connector.

11 Ensure the clip (P) is placed over the


temperature probe to ensure correct orientation.
Note: If the patient circuit is being assembled
with the ventilator turned off skip steps 16
P and 20.

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”
12 Connect the humidifier heater wire lead (Q) to Button.
the port on the inspiratory heated limb (H). 17 Occlude the flow
sensor to prevent any

flow across the sensor


 H Q wires.

Caution: To avoid contamination of the flow


sensor use gloves when calibrating.

32
Patient circuits

18 Press the Start calibration button and the


following text “Calibrating..” will be displayed Note: Application of the ET tube is not
above the button covered in this manual.
19 When the calibrations has passed the test
“Calibration completed” will appear. 5.2.7 Fitting the test lung
20 The flow sensor is now calibrated. Once the patient circuit is assembled connect the
test lung (X) to the flow sensor (W). The circuit is
5.2.5 Fitting the flow sensor to a BC6188 ready for pre use functional testing.
patient circuit
21 Remove the dust cap (U) W
from the ET manifold (V). V U X

22 Insert the flow sensor (W)


into the ET manifold (V).
V W

23 The patient circuit is now


ready to use.

Note: Application of the ET tube is not


covered in this manual.

5.2.6 Fitting the flow sensor to a BC6198


patient circuit
24 Remove the dust cap (U)
from the ET manifold (V). U
V

25 Insert the flow sensor (W)


into the ET manifold (V). W

26 The patient circuit is now


V

ready to use.

33
Patient circuits

5.3 Assembly of BC6188/DHW patient


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


exhalation port from patient port.
2 Fit the fresh gas port bacterial filter 
(autoclavable) (B) to the fresh gas to patient port.
C


D

B



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

5.3.2 Humidification chamber


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

Note: Please refer to the humidifier user


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

34
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 
 
I


N
9 Ensure the clip (P) is placed over the
temperature probe to ensure correct orientation.


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

10 Connect the inspiratory limb heater wire lead to


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

 H Q

11 Connect the expiratory heater wire lead to the


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

Q

7 Connect the proximal airway line (L) to the


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

M
L


R

35
Patient circuits

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



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


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


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

14 Connect the flow 5.3.3 Fitting the test lung


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

the rear notch of the


flow sensor connector.
Z

Note: If the patient circuit is being assembled


with the ventilator turned off skip steps 15
and 19.

15 The ventilator will alarm calibrate flow sensor.


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

flow across the sensor


wires.

Caution: To avoid contamination of the flow


sensor use gloves when calibrating .

36
Patient circuits

5.4 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 5.2 on page 30 or the BC6188/DHW
patient circuit section 5.3 on page 34.
2 Disconnect the proximal airway line (A) from the
ET manifold (B) at the Luer connector. 5.4.1 Fitting a dual limb nCPAP generator.
7 Remove the nCPAP generator (H) from its

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

A


H

3 Disconnect the ET manifold (B) from the


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


B
D

C

Note: Application of the prongs/mask are not


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

E

5 Connect the proximal airway line (F) to the


adaptor.

37
Patient circuits

5.5 Modification of BC6188 or BC6188/


DHW circuits for non-invasive Note: Please refer to the humidifier user
single limb ventilation. manual for warnings, cautions and operating
instructions.
Note: The flow sensor and flow sensor cable
are not required for this set up. Please refer to patient circuit instructions for
use for warnings and cautions and operating
5.5.1 Bacterial filters instructions.

Note: It is recommended that bacterial filters 1 Remove the patient circuit from protective bag.
are fitted in the fresh gas supply and on the
patient side of the exhalation block. Note: The BC6188 circuit is not supplied with
a humidification chamber (G).
1 Fit the fresh gas port bacterial filter
(autoclavable) (A) to the fresh gas to patient port 2 Connect the 15mm female end (C) of the fresh
(B). gas supply line (D) to the to the bacterial filter
fitted to the ventilator port marked “Fresh Gas to
Patient” (E).


A 

 C
B


D

Please refer to the consumable catalogue or the


SLE website for part numbers.

5.5.2 Humidification chamber


Ensure that the chamber is fitted securely to the
G

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

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


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

38
Patient circuits

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

 
H

7 Connect the proximal airway line (K) to the


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

L

K

H

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


 N
M

9 Ensure the clip (O) is placed over the


temperature probe to ensure correct orientation.

O

10 Connect the humidifier heater wire lead (O) to


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

39
Patient circuits

11 Connect the heater wire (O) and the temperature


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

O

P

5.5.4 Fitting a single limb nCPAP generator.


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

Q

14 Connect the proximal airway line (I) to the


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

R


40
Patient circuits

5.6 Modification of BC6188 or BC6188/


DHW circuits for non-invasive Note: Please refer to the humidifier user
single limb O2 therapy. manual for warnings, cautions and operating
instructions.
Note: The flow sensor and flow sensor cable
are not required for this set up. Please refer to patient circuit instructions for
use for warnings and cautions and operating
5.6.1 Bacterial filters instructions.

Note: It is recommended that bacterial filters 1 Remove the patient circuit from protective bag.
are fitted in the fresh gas supply and on the
patient side of the exhalation block. Note: The BC6188 circuit is not supplied with
a humidification chamber (G).
1 Fit the fresh gas port bacterial filter
(autoclavable) (A) to the fresh gas to patient port 2 Connect the 15mm female end (C) of the fresh
(B). gas supply line (D) to the to the bacterial filter
fitted to the ventilator port marked “Fresh Gas to
Patient” (E).


A 

 C
B


D

Please refer to the consumable catalogue or the


SLE website for part numbers.

5.6.2 Humidification chamber


Ensure that the chamber is fitted securely to the
G

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

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


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

41
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

5.6.3 Fitting the temperature probes


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

H

J 
K
8 Ensure the clip (M) is placed over the
temperature probe to ensure correct orientation.

M

9 Connect the humidifier heater wire lead (N) to


the port on the inspiratory heated limb (H).

 H N

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


into its original packaging.

42
Patient circuits

10 Connect the heater wire (O) and the temperature


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

O

P

5.6.4 Fitting an oxygen therapy nasal cannula.


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

11 Remove the cannula (Q) from it packaging.


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

R

Q

R


H
G

Note: Application of the cannula is not


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

43
Patient circuits

This page is intentionally left blank

44
Ventilation - Invasive

Ventilation - Invasive
“CPAP” on page 46
“CMV” on page 48
“PTV” on page 50
“PSV” on page 52
“SIMV” on page 54
“HFOV+CMV” on page 58
“HFOV” on page 56

45
Ventilation - Invasive

6. Ventilation - Invasive
6.1 CPAP

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

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

RR Backup Rise time Trig Sens


Additional
Parameters

BPM Seconds l/min

Ti CPAP PIP O2
Manual
Breath

Seconds mbar mbar %

Manual Ti CPAP PIP O2


breath Inspiratory Continuous Peak inspiratory Oxygen
time positive airway pressure in concentration
The inspiration pressure in mbar. For delivered to
mbar manual and patient.
time in seconds.
backup breaths.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The CPAP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost or O2
backup rate. PIP cannot be decreased below the suction
B. The RR backup rate control set CPAP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

46
Ventilation - Invasive

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


30.0 18.00 100 15 35
7.0 0.25 0 0


00.0 00.0 Ventilation with
the Apnoea
alarm “OFF”

Warning: The user


PIP CPAP must use an
(mbar) (mbar) alternative method
of detecting an
 apnoeic episode,

20 7.0 with the Apnoea
alarm turned
“OFF”.

15.0 4.0


11 1
PIP CPAP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

47
Ventilation - Invasive

6.2 CMV

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

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

RR Backup Rise time


Additional
Parameters

Seconds

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual RR Ti PEEP PIP VTV O2


breath Respiratory rate Inspiratory Positive Peak inspiratory Press and hold Oxygen
in breath per time expiratory end pressure in the control for 2 concentration
minute. pressure in mbar. For seconds to delivered to
The inspiration
time in seconds. mbar. manual and switch On/Off. patient.
backup breaths. Press confirm to
acknowledge.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost or O2
backup rate. PIP cannot be decreased below the suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

48
Ventilation - Invasive

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


30.0 18.00 35
7.0 0.25 0


00.0 00.0
PIP PEEP
(mbar) (mbar)


20 7.0
15.0 4.0


11 1
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

49
Ventilation - Invasive

6.3 PTV

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

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

RR Backup Rise time Trig Sens


Additional
Parameters

Seconds l/min

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual RR Ti PEEP PIP VTV O2


breath Respiratory rate Inspiratory Positive end Peak inspiratory Press and hold Oxygen
in breath per time expiratory pressure in the control for 2 concentration
minute. pressure in mbar. For seconds to delivered to
The inspiration
time in seconds. mbar. manual and switch On/Off. patient.
backup breaths. Press confirm to
acknowledge.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost or O2
backup rate. PIP cannot be decreased below the suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

50
Ventilation - Invasive

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


30.0 18.00 100 15 35
7.0 0.25 0 0


00.0 00.0 Ventilation with
the Apnoea
alarm “OFF”

Warning: The user


PIP PEEP must use an
(mbar) (mbar) alternative method
of detecting an
 apnoeic episode,

20 7.0 with the Apnoea
alarm turned
“OFF”.

15.0 4.0


11 1
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

51
Ventilation - Invasive

6.4 PSV

Mode type: Invasive Prior to and after connection, it is the user’s responsibility to adjust
and monitor the 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/min to Termination
Additional percentage (%). sensitivity
Parameters Rise time The default is Sets the
Active for 120 Alters the changed from termination
seconds when pressure wave 0.6 l/min to sensitivity the
mode selected. shape. 50%. patient breath.

RR Backup Rise time Trig Sens Term Sens


Additional
Parameters

l/min %
Seconds

RR Ti Max PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual RR Ti Max PEEP PIP VTV O2


breath Respiratory rate Inspiratory Positive end Peak inspiratory Press and hold Oxygen
in breath per time expiratory pressure in the control for 2 concentration
minute. The inspiration pressure in mbar. For seconds to delivered to
mbar manual and switch On/Off. patient.
time in seconds.
backup breaths. Press confirm to
acknowledge.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost or O2
backup rate. PIP cannot be decreased below the suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

52
Ventilation - Invasive

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


30.0 18.00 100 15 35
7.0 0.25 0 0


00.0 00.0 Ventilation with
the Apnoea
alarm “OFF”

Warning: The user


PIP PEEP must use an
(mbar) (mbar) alternative method
of detecting an
 apnoeic episode,

20 7.0 with the Apnoea
alarm turned
“OFF”.

15.0 4.0


11 1
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

53
Ventilation - Invasive

6.5 SIMV

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

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

RR Backup Rise time P Support Trig Sens Term Sens


Additional
Parameters

Seconds mbar l/min %

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar ml %

Manual RR Ti PEEP PIP VTV O2


breath Respiratory rate Inspiratory Positive end Peak inspiratory Press and hold Oxygen
in breath per time expiratory pressure in the control for 2 concentration
minute. The inspiration pressure in mbar. For seconds to delivered to
mbar manual and switch On/Off. patient.
time in seconds.
backup breaths. Press confirm to
acknowledge.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost or O2
backup rate. PIP cannot be decreased below the suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

54
Ventilation - Invasive

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


30.0 18.00 100 15 35
7.0 0.25 0 0


00.0 00.0 Ventilation with
the Apnoea
alarm “OFF”

Warning: The user


PIP PEEP must use an
(mbar) (mbar) alternative method
of detecting an
 apnoeic episode,

20 7.0 with the Apnoea
alarm turned
“OFF”.

15.0 4.0


11 1
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

55
Ventilation - Invasive

6.6 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.
Press and hold Sigh RR
the control for 1
Press and hold
seconds to the control for 2
switch On/Off.
seconds to
switch On/Off.
Press confirm to
acknowledge.
Additional (Default 30 BPM Sigh Ti Sigh P
Parameters when On). Sets Sets the Sets the
Active for 120 the respiratory inspiratory time inspiratory
seconds when rate for the sigh for the sigh pressure for the
mode selected. breaths. breath. sigh breath.

Oscillation
Pause

Sigh RR Sigh Ti P Support Sigh P


Additional
Parameters

BPM Seconds mbar

Frequency I:E MAP ΔP VTV O2

Sigh

Hz Ratio mbar mbar %

Sigh* Frequency I:E MAP ΔP O2


The sigh control HFO frequency Ratio for Mean airway Delta pressure Oxygen
will initiate a in Hertz (Hz) inspiration to pressure in in mbar. concentration
pause at the set expiration (1:1, mbar delivered to
Sigh Ti. 1:2 & 1:3) patient.

Alternate Interactive controls Interactive controls Alternate


function The Sigh Hold will use the user MAP and Sigh P function
Sigh hold preference set 5 or 10 second A. The MAP control will O2 Boost or O2
pause. automatically start to increase the suction
Sigh P when it equals the set Sigh
P.
B.The MAP control will
Caution*: With the Sigh RR set to Off the Sigh Ti can automatically start to decrease the
be set anywhere between 0.1 and 3 seconds for
Sigh P when decreased
manual Sigh’s. When Sigh RR is subsequently
C. The Sigh P cannot be decreased
turned on the Sigh Ti could be incompatible with the below the set MAP.
set Sigh RR. The user will have to adjust the Sigh Ti
D. The Sigh P can be increased
or the Sigh RR accordingly.
independently of the set MAP but
only 15 mbar above the set MAP.

Note. The above values are shown at their factory


default settings.

56
Ventilation - Invasive

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


30.0 18.00 35
7.0 0.25 0


00.0 00.0
Paw Paw
(mbar) (mbar)


17
5.0 2.0


-7
High Paw Low Paw
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: Low Alarm name:
High Paw Low Pressure
(Threshold Visible) (Threshold Visible)

57
Ventilation - Invasive

6.7 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 HFO
the control for 1 Activity
seconds to Allows the
switch On/Off.
selection of
oscillations in
Additional both inspiratory
Parameters and expiratory
Active for 120 phases. or just
seconds when the expiratory
mode selected. phase.

Oscillation
Pause

HFO Activity
Additional
Parameters

RR Ti Frequency PEEP PIP ΔP O2

BPM Hz mbar mbar mbar %


Seconds

RR Ti Frequency PEEP PIP ΔP O2


Respiratory rate Inspiratory HFO frequency Positive end Peak inspiratory Delta pressure Oxygen
in breath per time in Hertz (Hz) expiratory pressure in in mbar. concentration
minute. pressure in mbar. For delivered to
The inspiration
time in seconds. mbar manual and patient.
backup breaths.

Interactive controls Interactive controls Alternate


A. The Ti control cannot be The PEEP control cannot be function
increased beyond the set RR increased beyond the set PIP. The O2 Boost or O2
backup rate. PIP cannot be decreased below the suction
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

58
Ventilation - Invasive

HFO+CMV
default alarm
thresholds



Paw Paw
(mbar) (mbar)


17
5.0 2.0


-7
High Paw Low Paw
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: Low Alarm name:
High Paw Low Pressure
(Threshold Visible) (Threshold Visible)

59
Ventilation - Invasive

6.8 Common warnings 6.9.1 Common alternate functions


(Conventional ventilation)
Warning: The ventilator must not be
6.9.1.1 Manual breath or Inspiratory hold
connected to the patient during the basic set-
If a inspiratory hold time has been set in the user
up procedure.
preferences the Manual Breath button is replaced
by the Inspiratory Hold button. Pressing the button
Warning: Do not enter the “Standby” mode will initiate a breath up to the set inspiratory time.
when connected to a patient. No ventilation is (this maximum time can be set to either 5 or 10
delivered. seconds). Releasing the button will end the breath.
The inspiratory hold will use the set PIP.
Warning: The user shall ensure that all the
6.9.1.2 O2 Boost or O2 suction
alarm thresholds are set to appropriate levels
depending on patient condition. If this feature has been enabled the user can select
when required O2 Boost or O2 suction through the
6.9 Common cautions O2 parameter control.
Caution: The basic set-up routines described 6.9.2 Common alternate functions (High
in this chapter are only to allow the user (i.e. frequency ventilation)
clinician/medical staff) to enter each mode in
a safe manner. 6.9.2.1 Sigh or Sigh hold
If a Sigh hold time has been set in the user
It is the responsibility of the user to set safe preferences the Sigh button is replaced by the Sigh
ventilation parameters. The ventilation Hold button. Pressing the button will initiate a Sigh
parameters stated in this chapter are used breath up to the set inspiratory time. (this maximum
only to guide the user, if the user deems these time can be set to either 5 or 10 seconds).
parameters unsuitable for the patient then Releasing the button will end the breath. The
appropriate parameters should be selected. inspiratory hold will use the set Sigh P.
The ventilator may display the parameters as 6.9.2.2 O2 Boost or O2 suction
set by the user through the user preferences.
If this feature has been enabled the user can select
The parameters stated in this chapter should when required O2 Boost or O2 suction through the
never override the user choice of ventilator O2 parameter control.
settings.

Caution: The flow sensor is a serviceable item 6.10 Ventilation without a flow sensor
and may require cleaning during use. When using the ventilator without a flow sensor the
following features will not be available.

VTV control

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

Waveforms and loops


Flow, Volume

60
Ventilation - Non invasive

Ventilation - Non-invasive
“Non-invasive - Dual limb”
“nCPAP D” on page 62
“NIPPV D” on page 64
“nHFOV D” on page 66
“Non-invasive - Single limb”
“nCPAP S” on page 68
“O2 therapy” on page 70

61
Ventilation - Non invasive

7. Non-invasive - Dual limb


7.1 nCPAP D

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

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

RR Backup Rise time Trig Sens


Additional
Parameters

BPM Seconds %

Ti CPAP PIP O2
Manual
Breath

Seconds mbar mbar %

Manual Ti CPAP PIP O2


breath Inspiratory Continuous Peak inspiratory Oxygen
time positive airway pressure in concentration
The inspiration pressure in mbar. For delivered to
mbar manual and patient.
time in seconds.
backup breaths.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The CPAP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost.
backup rate. PIP cannot be decreased below the
B. The RR backup rate control set CPAP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

62
Ventilation - Non invasive

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


100 15
0
 Ventilation with
 the Apnoea
alarm “OFF”

Warning: The user


PIP CPAP must use an
(mbar) (mbar) alternative method
of detecting an
 apnoeic episode,

20 7.0 with the Apnoea
alarm turned
“OFF”.

15.0 4.0


11 1
PIP CPAP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

63
Ventilation - Non invasive

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

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

RR Backup Rise time


Additional
Parameters

Seconds

RR Ti PEEP PIP VTV O2


Manual
Breath

BPM Seconds mbar mbar %

Manual RR Ti PEEP PIP O2


breath Respiratory rate Inspiratory Positive end Peak inspiratory Oxygen
in breath per time expiratory pressure in concentration
minute. pressure in mbar. For delivered to
The inspiration
time in seconds. mbar. manual and patient.
backup breaths.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The PEEP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost.
backup rate. PIP cannot be decreased below the
B. The RR backup rate control set PEEP.
cannot be increased beyond the
allowable Ti.
C. The Rise time cannot be
increased beyond the set Ti

Note. The above values are shown at their


factory default settings.

64
Ventilation - Non invasive

NIPPV D
default alarm
thresholds



PIP PEEP
(mbar) (mbar)


20 7.0
15.0 4.0


11 1
PIP PEEP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

65
Ventilation - Non invasive

7.3 nHFOV D
Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust
Dual limb patient circuit. 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.
Press and hold Sigh RR
the control for 1
Press and hold
seconds to the control for 2
switch On/Off.
seconds to
switch On/Off.
Press confirm to
acknowledge.
Additional (Default 30 BPM Sigh Ti Sigh P
Parameters when On). Sets Sets the Sets the
Active for 120 the respiratory inspiratory time inspiratory
seconds when rate for the sigh for the sigh pressure for the
mode selected. breaths. breath. sigh breath.

Oscillation
Pause

Sigh RR Sigh Ti P Support Sigh P


Additional
Parameters

BPM Seconds mbar

Frequency I:E MAP ΔP VTV O2

Sigh

Hz Ratio mbar mbar %

Sigh* Frequency I:E MAP ΔP O2


The sigh control HFO frequency Ratio for Mean airway Delta pressure Oxygen
will initiate a in Hertz (Hz) inspiration to pressure in in mbar. concentration
pause at the set expiration (1:1, mbar delivered to
Sigh Ti. 1:2 & 1:3) patient.

Alternate Interactive controls Interactive controls Alternate


function The Sigh Hold will use the user MAP and Sigh P function
Sigh hold preference set 5 or 10 second A. The MAP control will O2 Boost.
pause. automatically start to increase the
Sigh P when it equals the set Sigh
P.
B.The MAP control will
Caution*: With the Sigh RR set to Off the Sigh Ti can
automatically start to decrease the
be set anywhere between 0.1 and 3 seconds for
Sigh P when decreased
manual Sigh’s. When Sigh RR is subsequently
C. The Sigh P cannot be decreased
turned on the Sigh Ti could be incompatible with the
below the set MAP.
set Sigh RR. The user will have to adjust the Sigh Ti
D. The Sigh P can be increased
or the Sigh RR accordingly.
independently of the set MAP but
only 15 mbar above the set MAP.

Note. The above values are shown at their factory


default settings.

66
Ventilation - Non invasive

nHFOV D
default alarm
thresholds



Paw Paw
(mbar) (mbar)


17
5.0 2.0


-7
High Paw Low Paw
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: Low Alarm name:
High Paw Low Pressure
(Threshold Visible) (Threshold Visible)

67
Ventilation - Non invasive

8. Non-invasive - Single limb


8.1 nCPAP S

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

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

RR Backup Rise time Trig Sens


Additional
Parameters

BPM Seconds %

Ti CPAP PIP O2
Manual
Breath

Seconds mbar mbar %

Manual Ti CPAP PIP O2


breath Inspiratory Continuous Peak inspiratory Oxygen
time positive airway pressure in concentration
The inspiration pressure in mbar. For delivered to
mbar manual and patient.
time in seconds.
backup breaths.

Alternate Interactive controls Interactive controls Alternate


function A. The Ti control cannot be The CPAP control cannot be function
Inspiratory hold increased beyond the set RR increased beyond the set PIP. The O2 Boost.
backup rate. PIP cannot be decreased below the
B. The RR backup rate control set CPAP.
cannot be increased beyond the
allowable Ti.

Note. The above values are shown at their


factory default settings.

68
Ventilation - Non invasive

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


100 15
0
 Ventilation with
 the Apnoea
alarm “OFF”

Warning: The user


PIP CPAP must use an
(mbar) (mbar) alternative method
of detecting an
 apnoeic episode,

15 9 with the Apnoea
alarm turned
“OFF”.

15.0 4.0


8 1
PIP CPAP
Set maximum and Set maximum and
minimum minimum
thresholds. thresholds.
High Alarm name: High Alarm name:
PIP too high PEEP too high
(Threshold Visible) (Threshold
Low Alarm name: Invisible)
PIP too low Low Alarm name:
(Threshold Pressure below low
Invisible) threshold
(Threshold Visible)

69
Ventilation - Non invasive

8.2 O2 therapy
Mode type: Non-invasive. Prior to and after connection, it is the user’s responsibility to adjust
Single limb patient circuit. and monitor the ventilation parameters.

Flow O2

mbar l/min %

Flow O2
Set the flow in Oxygen
l/min concentration
delivered to
patient.

Alternate
function
O2 Boost.

Note. The above values are shown at their


factory default settings.

Note: O2 therapy has no alarms thresholds.

Note: O2 therapy mode displays the O2 (%)


trend by default.

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


reading during the automatic oxygen
calibration routine.

70
Ventilation - Non invasive

8.3 Common warnings


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

Warning: Do not enter the “Standby” mode


when connected to a patient. No ventilation is
delivered.

Warning: The user shall ensure that all the


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

8.4 Common cautions


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

8.5 Common note


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

71
Ventilation - Non invasive

This page is intentionally left blank.

72
Operational features

Operational features

73
Operational features

9. Operational features
Warning: In a “Mains Power Fail” condition
9.1 General and if the user clears the “Mains Power Fail”
alarm, the next power related alarm that will
9.1.1 Standby Mode
trigger will be the medium priority “Battery
Warning: Do not enter the “Standby” mode Low” alarm. This indicates that the internal
when connected to a patient. No ventilation is power source has reached 25% capacity. The
delivered. user shall remove the patient to an alternative
form of ventilation at this point if mains power
9.1.2 Apnoea alarm set to “Off” cannot be restored. If the user clears the
In any mode where the user can set the Apnoea medium priority “Mains Power Fail” alarm,
alarm to “Off” the backup breaths are disabled even the next power related alarm that will trigger
when turned “On” unless apnoea is reinstated. will be the high priority “Battery Low” alarm.
This indicates that the internal power source
Warning: The user must use an alternative has a less than 10 minutes remaining battery
method of detecting an apnoeic episode, life.
whether ventilating invasively or non
invasively with the Apnoea alarm turned Once all battery power has been exhausted the
“OFF”. complete power fail alarm will sound and the
ventilator will cease to operate.
9.1.3 Reserve power source
Warning. The ventilator can be used with a
The ventilator has a reserve power source (2 completely discharged battery, but a note
internal batteries) that will continue to operate the must be taken that in the event of a mains
ventilator in the event of mains power failure. power failure the ventilator will cease to
Mode 100% to 25% 50% to 25% ventilate the patient.

Standby 130 40
9.1.4 Parameter Memory
CMV 120 35 The user should be aware that the ventilator will
remember user parameter settings when switching
HFO+CMV 105 30 between modes. Though when the setting is
NIPPV 120 35 remembered between ventilatory modes the
parameter title may change. An example is the
All times are in minutes. CPAP parameter in CPAP mode becomes the
The operation of the ventilator does not change PEEP parameter in CMV mode.
when on the reserve power source.
9.1.5 HFO variable I:E ratio (Only available with
The operation of the ventilator does not change HFO and NHFOV options)
when charging the reserve power source. The variable I:E ratio allows the user to increase the
expiratory phase in proportion to the inspiratory
The ventilator does not have to be turned on to
phase by the indicated ratio 1:2 or 1:3.
charge the batteries. During use the ventilator will
keep the batteries fully charged.
Warning: Inappropriate changes in the I:E
In the event of a mains power failure a “Main Power ratio may result in a reduction of the volume
Fail” alarm will sound and be displayed in the alarm for each HFO cycle and the subsequent
panel. The alarm is high priority. minute volume delivered to the patient.
Secondary monitoring of TcPO2 may be
The user can suspend the “Main Power Fail” alarm
required.
by pressing the Reset button when the “Main Power
Fail” alarm is present.

74
Operational features

9.1.6 Trigger sensitivity 9.2 O2 Suction


With a flow sensor fitted.
The breath trigger sensitivity needs to be set in all Note: O2 suction is only available if activated
patient interactive modes (default 0.6 ml). in user preferences. See “User preferences”
Setting the breath trigger sensitivity at its most on page 184.
sensitive level (0.2ml) may allow the ventilator to
interpret background noise in the patient circuit as The O2 suction feature allows the user to increase
patient breathing, resulting in auto-triggering. the delivered % of oxygen prior to, during and after
When the ventilator is used with a flow sensor the a suctioning procedure for a fixed time.
ventilator monitors gas flow to detect the patient
breath. To activate O2 Suction press and hold O2
When the ventilator is used without a flow sensor the O2 parameter control for 3
the ventilator monitors pressure change to detect seconds.
the patient breath.
Without a flow sensor fitted.
The breath trigger sensitivity needs to be set in all “O2 Suction in
Standby” message O2 Suction
patient interactive modes. Default 50%. in Standby
Setting the breath trigger sensitivity at its most is displayed above
sensitive level (100%) may allow the ventilator to the O2 parameter
interpret background noise in the patient circuit as control (the control
patient breathing, resulting in auto-triggering. is renamed “O2 O2 Suction
When the ventilator is used with a flow sensor the suction”).
ventilator monitors gas flow to detect the patient The plus/minus and
breath. confirm button also
become active. %
When the ventilator is used without a flow sensor
the ventilator monitors pressure change to detect
the patient breath. Note: O2 suction control can be set between 1
9.1.7 Volume Targeted Ventilation, Vte (VTV) to 10% above the current setting or 100%. See
“User preferences” on page 184.
9.1.7.1 Ti
When VTV is set to ON in CPAP, CMV, PTV, PSV The colour of the ‘eyebrow’ bar of the O2 Suction
and SIMV, if the inspiratory volume exceeds a % O2 parameter control remains the
safety limit, the breath is terminated, to prevent same for the part that represents the
over-distension of the lung. This will result in a lower original % O2 setting, but the colour
measured Ti than set. The actual inspiratory time is changes to red for the part that %
displayed in the lung mechanics and measurement represents the O2 increase. The
panel as Ti meas. example shows a set percentage of 30% with a
default boost of 5%.
9.1.7.2 Vte Target Resolution
The tidal volume parameter control has three The user can increase or decrease the % O2, but it
different resolutions. cannot be reduced below the original set value.
From 2ml to 10ml the parameter increments in
0.2ml steps (Fine resolution). The user presses confirm button.
This action starts the O2 boost O2 Boost in
Progress
From 10ml to 100ml the parameter increments in procedure.
1ml steps (Standard resolution). A message “O2 Boost in Progress”
2.59 (s)
message is displayed above the “O2
From 100ml to 300ml the parameter increments in
Suction” parameter control for a O2 Suction
5ml steps (Coarse resolution).
countdown of 3 minutes.
9.1.8 Max Ti in PSV The ventilator waits for a
In PSV mode the Ti parameter is marked Max Ti disconnection in the following 3
minutes. %
because the termination sensitivity control (stop
support at %) can terminate the breath before the
set inspiratory time is reached. If the user presses and holds the O2 Suction
parameter control and then presses the confirm
9.1.9 Suctioning (Closed suction). button before 3 minutes and before the control times
Closed suction catheters can be used in all invasive out, the procedure is cancelled.The % O2 returns to
modes. No special setting is required for the use of original value and message clears.
a closed suction catheter.

75
Operational features

If the user doesn’t disconnect the patient during the The colour of the ‘eyebrow’ bar of the O2 Boost
3 minute window the boost will automatically finish. % O2 parameter control remains the
same for the part that represents the
When the user disconnects the original % O2 setting, but the colour
patient. The ventilator will display a O2 Pre changes to red for the part that %
Suction in
message “O2 Pre Suction in Progress represents the O2 increase. The
Progress” and will start counting down example show a set percentage of 30% with a
1.59 (s)
for 2 minutes. default boost of 5%.
The alarm mute is automatically O2 Suction
instated. The user can increase or decrease the % O2, but it
During this time the ventilator waits for cannot be reduced below the original set value.
a re-connection. If the User doesn’t
reconnect the patient before the time % The user presses confirm button. This
O2 Boost in
is up, this will cause the ventilator to action starts the O2 boost procedure Progress
alarm. The procedure stops at that
point. A countdown timer is set for 2
1.59 (s)
When the user reconnects the patient minutes. After 2 minutes the
O2 Post
before the end of the 2 minute window procedure stops. O2 Boost
Suction in
for suctioning, the ventilator starts a Progress
new 2 minute countdown, at the If the user presses and holds the “O2
1.59 (s)
elevated % O2. A message states “O2 Boost” parameter control for 3
Post Suction in Progress”. seconds and then presses the %
O2 Suction
“Confirm” button before the time is up
The procedure will stop at the end of the Boost is cancelled and the % O2
the 2 minute countdown. setting returns to the original value.
%
9.3 O2 Boost

Note: O2 Boost is only available if activated in


user preferences. See “User preferences” on
page 184.
The O2 Boost feature allow the user to increase the
delivered % of oxygen to a preset or user set
increase for a maximum of two minutes.

To activate O2 Boost press and hold O2


the O2 parameter control for 3
seconds.

“O2 Boost in
Standby” message O2 Boost in
Standby
is displayed above
the O2 parameter
control (the control
is renamed “O2 O2 Boost
Boost”).
The plus/minus and
confirm button also
become active. %

Note: O2 Boost control can be set to between


1 to 10% above the current setting or 100%.
See “User preferences” on page 184.

76
Operational features

9.4 Alarm thresholds 9.4.2 Alarm thresholds for Oscillatory modes


(invasive and non invasive - dual limb).
The ventilator for each mode has sets of pressure
related alarm thresholds that are set by the user or 9.4.2.1 HFOV & NHFOV
auto set by the ventilator around the user set The diagrams A & B show the pressure alarm
parameters. thresholds (invasive and non invasive modes).
The only mode that does not have any pressure
related alarm thresholds is O2 therapy.

9.4.1 Alarm thresholds for conventional modes


(invasive and non invasive - dual limb).
The diagram below shows the pressure alarm
thresholds for conventional modes (invasive and
non invasive).

Diagram A

A. Zero pressure line A. Zero pressure line


B. Waveform B. Waveform
Alarm thresholds Alarm thresholds
1. Low Pressure (Low PEEP alarm control) 1. Low pressure (Low Paw alarm control) Autoset
Autoset and user adjustable. and user adjustable.
2. High PIP (High PIP alarm control). Autoset and 2. High pressure (High Paw alarm control)
user adjustable. Autoset and user adjustable.
3. High pressure threshold exceeded (+5 mbar 3. High pressure threshold exceeded (+5 mbar
above PIP). Autoset. above PIP). Autoset.
4. High pressure threshold exceeded (+20 mbar 4. High pressure threshold exceeded (+20 mbar
above PIP) Autoset. above PIP) Autoset.
5. Sub ambient (-2 mbar below zero pressure). 5. Unexpected drop in mean P. (-5 mbar below
Autoset. mean P). Autoset.
6. High PEEP (High PEEP alarm control) Autoset 6. Unexpected rise in mean P. (+5 mbar above
and user adjustable. mean P). Autoset.
7. Low PIP (Low PIP alarm control). Autoset and 7. Continuing positive pressure. (+10 mbar above
user adjustable. mean P for mor than 4 seconds). Autoset.
8. Fail to cycle. Autoset. 8.Sub ambient (Mean pressure to go -2 mbar
9. Continuing positive pressure. (+14 mbar above below zero pressure). Autoset.
CPAP/PEEP for mor than 10 seconds). Autoset.

77
Operational features

9.4.2.2 HFO+CMV (invasive - dual limb)


The diagram below shows the pressure alarm
thresholds (invasive mode).

Diagram B

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


delta P). Autoset.
2. Unexpected drop in delta P. (-5 mbar below
delta P). Autoset. A. Zero pressure line
B. Waveform
Alarm thresholds
1. Low pressure (Low Paw alarm control) Autoset
and user adjustable.
2. High pressure (High Paw alarm control)
Autoset and user adjustable.
3. High pressure threshold exceeded (+5 mbar
above PIP). Autoset.
4. High pressure threshold exceeded (+20 mbar
above PIP) Autoset.
5. Pressure change detected. (See “Alarm
message: Pressure change detected.” on
page 138.) Autoset.
6. Continuing positive pressure. (+10 mbar above
mean P for mor than 4 seconds). Autoset.
7. Sub ambient (Mean pressure to go -2 mbar
below zero pressure). Autoset.

78
Operational features

9.4.3 Alarm thresholds for conventional modes 9.5 Patient Circuits, Humidification
(non invasive - single limb). and Nitric Oxide Therapy
The diagram below shows the pressure alarm
thresholds for conventional modes (non invasive). 9.5.1 Autofeed Humidification chambers
When using autofeed humidification chambers the
waterbag should be mounted higher than the max
Delta P or MAX PIP being used.

MAX
Delta P
or
MAX PIP

A. Zero pressure line


B. Waveform
Alarm thresholds
1. Low Pressure (Low PEEP alarm control)
Autoset and user adjustable.
2. High PIP (High PIP alarm control). Autoset and
user adjustable.
3. High pressure threshold exceeded (+5 mbar
above PIP). Autoset.
4. High pressure threshold exceeded (+20 mbar
above PIP) Autoset.
5. Sub ambient (-2 mbar below zero pressure).
Autoset.
6. High PEEP (High PEEP alarm control) Autoset
and user adjustable.
7. Low PIP (Low PIP alarm control). Autoset and
user adjustable.
8. Fail to cycle. Autoset.
9. Continuing positive pressure. (+5 mbar above To calculate the approximate height of the water bag
CPAP/PEEP for mor than 10 seconds). Autoset. use the following conversion:
1 mbar = 1cm, then add 25cm to the calculated high
for the final height of the bag.
Mounting the bag lower could allow the ventilator to
pressurize the bag and thus prevent the chamber
from filling with water. Also, the bag in return
pressurizes the chamber which could cause high or
sustained pressure alarms to be triggered.

79
Operational features

9.5.2 Nitric Oxide Therapy 9.5.3 Nebulization of Medication


When the ventilator is used in conjunction with an 9.5.3.1 Pneumatically driven.
Inhaled Nitric Oxide Delivery System, the ventilator
requires two NO scavenging filters (SLE part Nº Warning: Do not use the flow sensor when
N4110 connected in parallel with a dual exhaust nebulizing medication.
hose assembly SLE part Nº N4110/10) fitted to the
exhalation block (remove the silencer). This is When using the ventilator with a nebulizer,
supplied as a complete kit under SLE part Nº the ventilator should be used as time cycled
N4110/20. The flow of exhausted gas exceeds the pressure limited device by removal of the flow
capability of a single scavenging filter. sensor.

Dual Exhaust Hose Assembly Removing the flow sensor from the ET
SLE Part No: N4110/10 manifold whilst still reconnected to the
ventilator is not advised as the “Breath Not
Detected” alarm will become active and mask
other alarm conditions that could arise.

When using a nebulizer kit with the patient circuit,


the nebulizer requires an additional flow of gas
which alters the prescribed set PIP and PEEP
levels.
Disconnect the tube with the temperature probe port
(A) from the tube (B).
Insert the nebulizer (C) into the circuit.

A B
C

Exhalation block

D
NO Scavenging Filter
SLE Part No: N4110

Caution: After using the ventilator with Nitric Connect the free end of the nebulizer supply tube
Oxide therapy, rinse the exhalation block with (D) to the base of the nebulizer.
water before cleaning, disinfection or
Connect the nebulizer to a flow meter.
sterilization. This is to remove any deposits of
NO that could react during steam autoclaving Operational Changes
with water to form Nitrous acid or Nitric acid.
Warning: When nebulizing using flows of 6 to
Warning: Using the ventilator with only one 10 l/min (dependant on the rate required for
N4110 scavenging filter, (fitted directly to the nebulizing), this will cause the PEEP and PIP
exhaust port) will cause a back pressure to be pressures to rise and will require adjustment
generated. This will cause all the pressure of the PEEP and PIP pressures at
readings to become slightly elevated. commencement and completion of
nebulizing.

When nebulization of the fluid is complete the flow


sensor should re connected and calibrated then
inserted back into the circuit.

80
Operational features

9.5.3.2 Nebulization Procedure 4 Insert the nebulizer and the T-piece in the
breathing circuit.
1 Note the set PIP and PEEP.
5 The Aerogen® USB controller for use with
2 Disconnect the flow sensor cable from the
Aerogen® Solo is powered from the Aerogen®
ventilator and press the “Continue without flow
Controller port situated on the rear of the
sensor” button.
ventilator.
3 Remove the flow sensor from the ET manifold.
4 Insert the nebulizer kit into the patient circuit.
5 Connect the nebulizer to a flow meter.
6 Fill the nebulizer with the fluid to be nebulized.
7 Increase the high PIP alarm threshold in the
pressure waveform window.
Note: Aerogen® USB Controller can only be
8 Set a flow of gas through the nebulizer via the
flow meter of 6 to 10 l/min (dependant on the operated from a USB port on any medical
rate required for nebulizing). electrical equipment approved to IEC/EN
60601-1 or Aerogen USB Controller AC/DC
9 Adjust the PIP and PEEP to compensate for the
Adapter.
increased flow of gas through the ET manifold.
10 After nebulization close off the flow meter. 6 Open the plug on the nebulizer and use a pre-
filled ampoule or syringe to add medication to
11 Connect the flow sensor and recalibrate.
the nebulizer. Close the plug.
12 Remove the nebulizer kit and reconnect the
inspiratory tube to the ET manifold. Note: To avoid damage to the Aerogen® Solo,
13 Re-fit the flow sensor between the ET manifold do not use a syringe with a needle.
and the ET tube.
7 To operate in 30 Minute Mode press the On/Off
14 Adjust the PIP and PEEP to compensate for the button once.
decreased flow of gas through the ET.
8 To operate in 6 Hour Mode press the On/Off
9.5.3.3 Nebulization using Aerogen® button from the off mode for >3 seconds.
9 Verify the correct mode of operation is selected.
Warning: Do not use the flow sensor when
nebulizing medication . 10 Verify that aerosol is visible.
When using the ventilator with a nebulizer, 11 When nebulization is complete remove the
the ventilator should be used as time cycled Aerogen® Solo and USB controller from the
pressure limited device by removal of the flow circuit.
sensor. 12 Calibrate and replace the flow sensor if required.
Removing the flow sensor from the ET
manifold whilst still connected to the
ventilator is not advised as the “Breath Not
Detected” alarm will become active and mask
other alarm conditions that could arise.

Caution: Read and study all instructions


supplied with Aerogen® USB Controller.

1 Perform a functional test of the Aerogen®


nebulizer prior to use as described in the
Aerogen® IFU.
2 Connect the Aerogen® Solo or Aerogen® Pro
nebulizer by firmly pushing into the T-piece.
3 Connect the Aerogen® USB Controller to the
nebulizer.

81
Operational features

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82
User interface - Standby mode

User interface description


“Standby mode” on page 84
“Ventilation mode” on page 95

83
User interface - Standby mode

10. User interface description 10.1.2 Information panel (2)


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

2
10.1.4.4 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 10.1.4.5 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) 10.1.4.6 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) 10.1.4.7 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
10.1.4.8 Utilities button (C)
10.1.1 User interface (1) This button selects the following sub panels:
The active display is referred to as the user Sensors (see “Sensors tab” on page 87)
interface. Apart from the ON/OFF buttons all other Brightness (see “Brightness tab” on page 87)
controls are through the user interface. All the System (see “System Tab” on page 87)
controls are touch controls requiring a single touch
Data (see “Data tab” on page 89)
to operate.

84
User interface - Standby mode

10.1.4.9 Calibration & Utilities button (F) 10.1.6 Alarm button


This has the same function as the Utilities button
(C).
Touching “Alarm” button
10.1.4.10 Layout button (D) (D) activates the Alarm
This button selects the layout sub panel. In standby tabs.
mode only the trends can be selected. (see “Layout
Tab” on page 90) D
10.1.4.11 Multi function button (G)
This button has the following functions:
Lock/unlock screen.(See section 10.2.13 on page
99).
The Alarm panel has three available tabs: Limits
Alarm reset and alarm acknowledge.(See section
(E), History (F) and Loudness (G).
10.1.6 on page 85)
Note: The multi function button also changes
shape when activated for the Continue F G
E
without flow sensor alarm condition.

10.1.5 Mode button & Start/Resume Ventilation


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

Note: The mode that will be highlighted will


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

Select the required mode from area (1) and then


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

1 Note: The Limits tab is nonfunctional in


standby mode.

See section 10.2 on page 95 for mode related


descriptions.

85
User interface - Standby mode

10.1.6.2 History tab 10.1.6.3 Loudness tab


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

The tab displays the following information for each


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

86
User interface - Standby mode

10.1.7.1 Sensors tab


The sensor tab allows the user to calibrate the flow Note: Night mode is automatically cancelled
on the activation of an alarm.
sensor or perform a one point O2 calibration.
10.1.7.3 System Tab
The system tab allows the user to select from the
following system related functions:
Set date and time (O)
User preferences (P)
Engineering mode (Q)
System information (R)
Screen Calibration (S)

O
Note: When the flow sensor is connected the P
flow sensor calibration button is selected by
default. When using the ventilator without the Q
flow sensor only the one point O2 calibration R
is selected by default.
S

Note: The latest calibration date & time will be


displayed above the button.

10.1.7.2 Brightness tab


The Brightness tab allows the user to select Day or 10.1.7.3.1 Set date and time
Night mode and set the screen brightness for the
these modes. The set time and date button allows the user to set
the time and date for the ventilator.
Note: Daylight saving has to be manually set
by the user when required.

1. Set the Date and date format


2. Set the time.
 

2
The user change the set percentage brightness for
each mode as stated below.
Day mode: the default setting on at 70%
(Range 30% to 100%)
Night mode: the default setting on at 30%
(Range 20% to 60%).
Note: Default date and time format defaults
Note: The day mode can only be decreased to
can be set through user preferences.
10% above the night mode setting. The night
mode can only be increased to 10% below the
day mode setting.

87
User interface - Standby mode

10.1.7.3.2 User preferences 10.1.7.3.4 System information


The user preferences button allows the user to set The system information button displays ventilator
the start up-defaults for the ventilator. system information.
The subsystem version numbers are used to
determine the overall software version which is
displayed on this panel. See chapter ’26. Software
version identification’ on page 175 for further
information on the software version.
Note: Display Board CPU vitals, Elapsed time
from last service and input gas pressures are
primarily for use by service personnel.

10.1.7.3.5 Screen Calibration


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

The access to the user preferences require the


security code to be entered.
See “User preferences” on page 184 for detailed
description.
10.1.7.3.3 Engineering Mode
The engineering mode button allows the service
engineer to access the setup and calibration
utilities.

Caution. Only trained service personnel


should access the screen calibration. For
information on screen calibration please
consult the service manual. See chapter ’32.
Accessories’ on page 196 for service manual
part number.

Warning. Incorrect calibration of the touch


screen will render the ventilator inoperable.

Caution. Only trained service personnel


should access the engineering mode. For
information on Engineering mode please
consult the service manual. See chapter ’32.
Accessories’ on page 196 for service manual
part number.

88
User interface - Standby mode

10.1.7.4 Data tab 10.1.7.5 Downloading screen captures


The data tab allows the user to select from the Turn on the ventilator and allow it to enter Standby
following export related functions: mode.
Patient log (T) Insert a USB memory
stick into the data port
Events log (U)
at the rear of the
Screen captures (V) ventilator.

T
U
Note: There are two USB ports on the rear of
V the ventilator. Use the port with the indicated.

USB

Activate the Utilities tabs (1) and select the Data tab
10.1.7.4.1 Patient log (2).

The patient log button exports patient Trends, 2


Waveforms, Alarm Log & Events Log. 
Pressing the button (T) will display the "Start Export"
button. If a USB memory stick is present the button
will be active. See “SLE 6000 Event and patient log
software” on page 188 for further information. 
10.1.7.4.2 Events log
1
The events log button exports the Events Log.
Pressing the button (U) will display the "Start
Export" button. If a USB memory stick is present the
button will be active. See “SLE 6000 Event and
patient log software” on page 188 for further Select the Screen Captures button
information.
10.1.7.4.3 Screen capture
The screen capture button exports the last 10
screen captures.
Pressing the button (V) will display the "Start Export"
button. If a USB memory stick is present the button Screen captures
will be active.
See how to take screen captures in section ’10.2.15
Screen capture’ on page 99.

89
User interface - Standby mode

On selection of the Screen Captures button the 10.1.8 Layout Tab


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

Screen captures Start export

W X Y

The ventilator will display a progress bar during the


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

The default selection in Standby mode is Trends.


To view trends in Standby mode press the Layout
Screen captures Start export
button and then the confirm button.

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

Note: If the user also exports the patient logs


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

The bitmaps can be viewed by most PC/MAC word


processor or file viewer applications.

90
User interface - Standby mode

10.1.8.1 Waveforms 10.1.8.2 Loops


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

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

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

Flow (Default On)


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

The waveform (1) can be configured to display.


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

91
User interface - Standby mode

10.1.8.3 Trends 10.1.8.3.1 Setting default trends.


The trends are the only option that will be displayed
From the Trends Edit panel select the display line to
in Standby mode.
be modified.
The user has the choice of displaying up to eight
trends simultaneously in four displays lines. Each
display line can show a maximum of two trends.
The ventilator stores 14 days of trend data for each
of the trends listed below.
The trends available in each display line are:
O2
PIP
PEEP
MAP
CPAP
ΔP
Vte
Vmin
RR This will activate a drop down menu.
Triggers
Resistance
Compliance
DCO2

Note: The user can display the same trend


twice in one display line.
The selection of trends is not affected by the
connection or disconnection of the flow
sensor.

The default selection for Standby mode1:


Display line 1: PIP/PEEP
Display line 2: O2/Off
The drop down menu lists all the trend data that can
Display line 3: MAP/Off
be displayed for that line.
Display line 4: Off/Off
The user can scroll
Note1. The defaults for display line 1 in a down by using single
arrow button (1).
 
ventilatory mode is different. The default is 4
Pressure (Live)/Off. Pressure (Live) is not a The user can jump to
trend but the pressure waveform in real time. the end of the list by 3
pressing double arrow
Caution. Setting the defaults in Standby mode button (2).
1
will override the defaults of the ventilatory When the user has
mode trends. If a trend is selected for Display moved away from the 2
line 1 no real time waveforms will be top of the list the up
displayed on entering a ventilatory mode. buttons (3 & 4)
become active.
Touch the required
trend to select.
Repeat the process
for other display lines.
To cancel the
selection press the
Layout button.
To confirm the
selection press the
confirm button.

92
User interface - Standby mode

The Trend panel has two Style related controls, 10.1.8.5.1 Zoom
Filled and Background. The Zoom function increases or
decreases the magnification of the Zoom
5 trend window time scale.
6
  The zoom button when touched
activates the plus and minus buttons. Cursor
The plus and minus buttons are used
Filled (5) - when turned on fills in the trend with to increase/decrease the Scroll
colour. magnification. Also displayed in the
Background (6) - when turned on applies a time bottom part of the panel are two icons 14:03:34
based grid to the background of all the trends. that link the plus/minus buttons to the Current Zoom
level of magnification. 1 hour
10.1.8.4 Single & double trend display
When a single trend is required for a display line the The default time view for all the
trend window will display the trend as a blue line. windows is 1 hour. Decreasing the
When two trends are displayed in the same display zoom magnification is limited to
line the second trend is orange and overlaid on top predefined steps of 2, 4, 6, 9, 12 & 24
the first. hours. Increasing the zoom
magnification s limited to predefined steps of 30 and
10.1.8.5 Viewing trends 15 minutes.
After setting the required trend As the magnification is increased the Current Zoom
   

views as previously described, Zoom


A cursor in the trend window locator bar 24 hour
press the confirm button to view will increase or decrease dependant
the trends in the waveform on the zoom period.
windows. B Cursor
The associated trend view
controls will now become active. 10.1.8.5.2 Scroll
These are located in the lower
C Scroll
The scroll function allows the user to
right hand corner of the D move the cursor line through the 14
waveform windows.
14:03:34
Zoom
days of trend data at the set
Displayed are the Zoom (A),
E Current Zoom
1 hour magnification.
Cursor (B) and Scroll (C)
F The scroll button when touched Cursor
buttons. The trend start time (D). activates the plus and minus buttons.
The set zoom magnification (E). Also displayed in the bottom part of
The trend window locator bar the panel are two icons that link the Scroll
(F). plus/minus buttons to the direction of 14:03:34
When selecting Zoom, movement.
Current Zoom
Cursor or Scroll the 1 hour
cursor line and trend Zoom
value box becomes
active for each trend
Cursor
window.
The values displayed in As the user scrolls into the trend
each box are coloured Scroll history the trend window locator bar Scroll
and correspond to the moves accordingly.
14:03:34 14:03:34
trend of the same colour The date will appear as the previous 07-04
for that window. Current Zoom
days trend data is entered. Current Zoom
1 hour
1 hour
The values are for the
points that the cursor
line intersects the trend
line.
If only one trend has ben selected for a particular
window only one value is shown.

93
User interface - Standby mode

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

the beginning of the next time window.


Time windows are dictated by the
Zoom magnification.

94
User interface - Ventilation mode

10.2 Ventilation mode 10.2.2.2 Parameter states


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

This will activate plus/minus


O2
buttons.

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


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

time counts down to zero (The time


is displayed in minutes and seconds). 10.2.2.4 Turning “ON” a parameter function
Some parameters are inactive until VTV
10.2.2 Parameters turned on. Any inactive parameter has
the text OFF in the centre of the Off
10.2.2.1 Parameter types eyebrow.
Time based controls [Blue]
RR, Ti, Ti Max, Frequency, I:E ratio
Press an hold the parameter for 2 VTV
Pressure/Volume controls [Orange]: seconds.
CPAP, PIP, PIP Max, MAP (in HFO), PEEP, Off
VTV, ΔP (in HFO), Flow/Fresh Gas (Oxygen
Therapy)
Oxygen [Green] The plus/minus VTV O2
Additional Parameters [Blue]: buttons and the
confirm button will 3.0
Rise Time, Backup RR, Sigh RR, Sigh Ti
appear.
Additional parameters [White]:
Trigger Sensitivity, Termination Sensitivity The user can adjust the parameter and then confirm
Additional parameters [Orange] the setting or just confirm the activation of the
P support, Sigh P (in HFO) parameter and then adjust the parameter as
previously described in section 10.2.2.3.
Note: If no action is taken the selection is
cancelled after 15 seconds.

95
User interface - Ventilation mode

10.2.3 Preview mode 10.2.4 Patient circuit selection


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

For patients requiring tidal volumes


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

Note: The selection of 15mm patient circuits


is only available for invasive ventilation.
By default, the Invasive tab will be selected on
Changing to non-invasive ventilation
startup, unless the user has pre-selected the non-
automatically selects 10mm patient circuits.
invasive tab as a default in the user preferences.
If already in a mode of ventilation, pressing the 10.2.5 Monitored values
mode button will bring up the mode panel with the
associated tab of the current mode. 10.2.5.1 Single column/double column
layout
On startup, the mode of ventilation that has been
The monitored values area to the right of
chosen in the user preferences will be pre-selected.
the waveform layout has two display
By default (factory default) this selection will be set
options. Single column with large
to ‘Invasive tab’. The selected mode button shall be
numbers and dual column with smaller
in ‘Selected’ state, all others shall be in ‘Available’
numbers.
state.
In single column mode the area displays
The user selects the ventilation mode of choice;
a maximum of 8 monitored values.
The controls of the selected mode shall appear
In double column mode the area displays
within the menu in ‘preview’ mode.
a maximum of 16 monitored values.
When already in a mode of ventilation, the settings
shall be the same as in the current mode, whenever 10.2.5.1.1 Switching between layouts
settings are common. The factory default is single column.The
In preview mode, the Confirm button will be default layout is set from user
available at all times. preferences, see “Interface tab” on
The user adjusts the ventilator parameters. page 185. Through user preferences the
user can set the user default to double
Presses parameter to be adjusted. column.
Parameter changes to ‘selected’ state. Which ever layout is selected the user in
User uses plus/minus keys to change the parameter a ventilatory mode can switch between
value. modes by touching the panel for 1
User presses a different parameter. second.
Previously pressed parameter returns to “available”
mode, but the parameter remains at the last
adjusted value. New parameter changes to
“selected” state.
User repeats process with other parameters if
required.
When the user is ready pressing the confirm button
accepts all the changes to the parameter controls
and activates the chosen mode.
The above procedure can be used when the user
wants to change more than one parameter at once,
while remaining in the same mode of ventilation.

96
User interface - Ventilation mode

10.2.6 Alarms tab - ventilatory mode 10.2.6.2 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.
10.2.6.2.1 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% above 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
10.2.6.1 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

97
User interface - Ventilation mode

10.2.6.2.2 Invasive oscillatory 10.2.8 Utilities tab - ventilatory mode


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

Low = 70% of the set PIP for the PIP 10.2.8.1 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.
10.2.6.2.4 Non invasive oscillatory
HFO High PIP (High Paw)
High = 10 mbar above MAP + (∆P ÷ 2)
HFO Low Paw (Low Pressure)
Low = 10 mbar below MAP - (∆P ÷ 2)
The text “Calibrating..” will appear above the button.
The ventilator will sound a medium priority alarm
10.2.7 History and Loudness and display the alarm message “Calibrate Flow
These tabs operate as described in “History tab” on Sensor.”
page 86 and “Loudness tab” on page 86. 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.

98
User interface - Ventilation mode

10.2.8.2 O2 calibration 10.2.13 Lock screen button


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

When locked all areas apart from the Lock screen


button are inactive.
In the event that an alarm is activated the screen is
automatically unlocked.
Note: In an alarm condition the lock screen
button becomes the alarm message “Reset”
button.
Press the “Start One Point O2 Calibration”.
The text “Calibrating..” will appear below the button Pressing the screen when locked will bring up the
and the O2% measured value will display the text information message “Screen is locked” and the
“CAL”. padlock icon will change colour to yellow.
The calibration will take approximately 4 minutes. To unlock the screen the user will have to press and
hold the button for 1 second.
The user can still set the O2% during the calibration.
Note: The O2 calibration button has no default 10.2.14 Pause/play
setting. If the Flow Sensor was the last used When in any ventilatory mode the pause
this will be selected. button will be available. The pause button
will pause the graphics section for 120
seconds.
Note: The O2 (%) trend will not display any
reading during the automatic oxygen To restart the graphics section the user
calibration routine. will have press the play button.

10.2.9 Brightness tab - ventilatory mode


10.2.15 Screen capture
See “Brightness tab” on page 87.
When in any ventilatory mode the pause
10.2.10 System tab - ventilatory mode or play button when touched and held for
3 seconds, will create a copy of the
The system tab has only two active buttons in a
screen and store it in the screen capture
ventilatory mode. Set Date and time and System
log.
information. All the other buttons are only available
when in Standby mode. See “Set date and time” on The screen capture log holds a maximum of 10
page 87 and “System information” on page 88 for screen captures.
more details. When the log is full the oldest screen capture is
discarded to create space for the new capture.
10.2.11 Data tab - ventilatory mode
Screen captures can only be downloaded in
The buttons are only available when in Standby “Standby mode”. See “Downloading screen
mode. See “Data tab” on page 89. captures” on page 89 for more information.
10.2.12 Layout
The layout tab allows the user to select and
configure the Waveform, Loops and Trend layouts.
The function is the same as in “Standby” mode, see
“Layout Tab” on page 90.

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User interface - Ventilation mode

10.2.16 Alarm bar 10.2.18 Oscillation Pause


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

10.2.17 Mode specific controls


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

100
Technical data

Technical Data
“Technical description” on page 102
“Oxygen Calibration Routines” on page 105
“N5402-REV2 & N5302 flow sensor” on page 106
“Technical specification” on page 108
“Alarms” on page 129
“Cleaning and disinfection” on page 157
“Troubleshooting Chart” on page 159
“Planned preventative Maintenance (PPM)” on page 165
“EMC compliance” on page 169
“Pneumatic unit diagram” on page 173
“Installation instructions” on page 178

101
Technical data

11. Technical description The pneumatic system consists of the following:


The ventilator is a computer controlled ventilator. An electronic oxygen blender blends the gas. The
The computer is divided into three electronic blended gas is then controlled via solenoid valves to
subsystems that are housed in the upper supply the conventional ventilation system and the
(electronic) section of the ventilator. oscillatory system.
The three sub systems are user interface, monitor For conventional ventilation the gas is controlled by
and controller. two pressure regulators that produce positive and
negative gas flows via the forward and reverse jets.
The user interface subsystem controls the user
interface, the display and the touchscreen. For oscillatory ventilation the gas flow is controlled
by four in-line high speed solenoid valves that
The controller subsystem regulates the pneumatic
produce the oscillatory gas flow via the forward and
systems of the ventilator.
reverse jets.
The monitor subsystem collects and processes flow
The exhalation block mounts onto two jet ports one
data and generates the alarms.
forward/reverse and one mean pressure.
Each subsystem communicates with the other two
Pressure is monitored via the proximal airway port
in a peer to peer protocol, i.e. no subsystem is in
through a pair of pressure transducers with data
complete control.
being sent to the monitor subsystem.
Flow is monitored by a dual hot wire anemometer
mounted at the ET manifold with the flow data being
sent to the monitor subsystem.
Invasive modes shall utilize a two limb patient circuit
but non-invasive ventilation can be carried out either
on a two limb or on a single limb circuit. In two limb
circuit operation one limb is connected to the fresh
gas port and the other is connected to the
exhalation port.

The primary method of generating the patient


pressure in two limb use is from the driving jets in
the exhalation port.

A single limb non-invasive patient circuit is


connected to the fresh gas port so all patient
pressure control is achieved by directly controlling
the fresh gas flow.
The ventilator is fitted with an auto-ranging power
supply that is capable of working with mains The exhalation port on the ventilator is not
supplies of 100V to 240V 50-60 Hertz. connected to the patient circuit. An increase in fresh
gas flow increases the patient pressure dependent
The ventilator can also run from an external 24V DC
on the pneumatic resistance of the exhalation ‘limb’
input.
of the single limb circuit (a single limb circuit still has
The ventilator carries an onboard backup power an exhalation limb or port but it is not connected to
source, which consists of two Lithium Ion battery the ventilator).
packs, that can power the ventilator in the event of a
The patient pressure is monitored and the fresh gas
mains power fail.
is controlled to maintain the desired patient
The batteries are charged from the ventilators pressure.
power supply. Internal battery power, 24V DC and
mains power supply are monitored by the ventilators
other subsystems.
In normal modes of ventilation and with a fully
charged battery, in a mains power fail situation the
ventilator will continue to operate on its reserve
power supply.

102
Technical data

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


pressure support will terminate when the inspiratory
modes (Invasive) flow drops to 5% of the peak value. The level of
The ventilator has the ability to be used as either a pressure support can be manually adjusted by use
pressure controlled, volume targeted ventilator, as a of the PIP parameter control.
pressure limited, time cycled ventilator, and as a
high frequency oscillation ventilator. PSV can be used in the weaning process. Weaning
is achieved by reducing the support level as the
12.1 CPAP infant is able to make more effort.
Continuous positive airway pressure In this mode all the patient's breath attempts are
pressure supported, but mechanical breaths are
The ventilator generates a continuous positive
delivered at the set parameters (Ti, PEEP and PIP)
airway pressure at a level set by the User. The
when a patient effort is recognised.
apnoea alarm will sound if the patient has not made
any breath attempts within the set apnoea period. 12.4.1 PSV & VTV (Volume Targeted Ventilation
The ventilator will provide backup breaths if This is as for basic PSV with Apnoea Support,
required. where the inspiratory pressure shall be controlled by
the ventilator to achieve the user set VTV (for
12.2 CMV assisted breaths).
Continuous Mandatory Ventilation
12.5 SIMV
In this mode the inspiratory cycle is initiated by the Synchronised Intermittent Mandatory
ventilator at a set BPM rate. The breaths are time Ventilation
cycled. The frequency of mandatory breaths is determined
by the BPM control. When a mandatory breath is
12.2.1 CMV & VTV (Volume Targeted Ventilation)
due an assist window opens and waits for a
This is as for basic CMV where the inspiratory patient's inspiratory effort. When this occurs the
pressure shall be controlled by the ventilator to ventilator delivers a synchronised breath (SIMV
achieve the user set VTV. breaths). Once the breath has been delivered the
assist window closes until the next set breath is due.
12.3 PTV
Time windows
Patient Triggered Ventilation

In this mode all the patient's breath attempts are


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

Pressure Supported Ventilation Mandatory breath point

This is a pressure limited mode of ventilation in


which each breath is patient triggered and
supported. The breath is patient triggered, pressure
supported and patient terminated. The infant
therefore has control of the whole cycle, i.e. the
inspiratory time and frequency. This form of
ventilation is dependant on the use of a flow sensor
placed between the ET tube connector and the Inspiratory time
patient circuit. Changes in flow or volume signal
detects spontaneous breathing. 60
Time window =
BPM
The termination sensitivity is also user adjustable
from 0% - 50%.

103
Technical data

12.5.1 SIMV with P Support 13. Description of ventilatory


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

SIMV with P Support produces time cycled, Note: O2 therapy is delivered by single limb
pressure limited breaths that are delivered at a set delivery circuit only.
BPM rate. Any additional patient breath attempts
are pressure supported (Flow cycled, pressure 13.1 nCPAP (Dual and Single limb)
limited).
Nasal Continuous positive airway pressure
12.5.2 SIMV & VTV (Volume Targeted Ventilation)
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
12.6 HFO required.
High Frequency Oscillation
13.2 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
12.7 HFO+CMV ventilator at a set BPM rate. The breaths are time
A combination of oscillations during the expiratory cycled.
or inspiratory & expiratory phase of a time cycled,
13.3 nHFO (Dual limb only)
pressure limited breath in CMV mode.
Nasal High Frequency Oscillation

In this mode, the ventilator shall deliver continuous


high frequency oscillation.

13.4 O2 Therapy (Single limb only)


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

104
Technical data

14. 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:
start up, 10 minutes, 30 minutes, 60 minutes, 90
minutes and then at 8 hourly intervals.
Engineering Mode
The second routine is the 21% and 100% oxygen
calibration (two point). This calibration should only
be carried out if the oxygen cell has been replaced
or has registered below 21% (cell drifting with age).

Warning: The user cannot carry out the two


point calibration whilst connected to a
patient. The ventilator has to be placed in
“Standby” mode and the calibration process Pressing the Two Point O2 Calibration button the
will deliver 21% O2 to the patient for 3 user will have to wait 6 minutes before carrying out
minutes. any new operation.

14.1 One Point O2 Calibration The ventilator will start with a 21% calibration for 3
minutes followed by a 100% calibration for 3
The user can carry out a one point calibration of the minutes.
system by accessing the oxygen sensor calibration
panel from the services panel. Warning: The user cannot select a ventilation
mode whilst the two point calibration process
The ventilator can be connected to a patient for this is running.
calibration.
The ventilator will continue to deliver the user set If the ventilator is carrying out the standard single
percentage of O2 during calibration. point 100% calibration the user will be unable to run
a two point calibration until it is complete.
The O2 measured value will read “CAL”.
In a ventilation mode the O2 measured value will
14.2 Two Point O2 Calibration read “CAL” in the O2 parameter control until the
routine is complete.
The two point calibration routine can only be
performed from the Engineering mode.
To carry out a two point calibration access
Engineering Mode from “Utilities” / “System” tab.

Engineering Mode

Type in the code: 0872 and press confirm.


This will activate the “Calibrate Oxygen System”
Engineering mode feature.

105
Technical data

15. N5402-REV2 & N5302 flow Press the Start calibration button and the following
text “Calibrating..” will be displayed above the
sensor button.
The ventilator employs a low dead space (<1ml),
heated wire anemometer sensor. To minimise dead When the calibrations has passed the test
space the sensor body fills much of the ET tube “Calibration completed” will appear.
adapter and patient circuit connection.
The flow sensor is now calibrated.
Caution: The flow sensor is a serviceable item
Note: The flow sensor should be calibrated
and may require cleaning during use.
every 24 hours whilst in use, if the patient’s
condition permits.
SLE offer two types of sensor the N5402-REV2
which is a reusable sensor or the N5302 which is a
single use flow sensor. Note: The Calibration procedure is the same
for the N5402-REV2 and N5302 sensors.

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

Warning: Do not use this flow sensor to


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

Note: The N5302 flow sensor is a single use


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

Before re-insertion into the patient circuit the user


must calibrate the flow sensor.

15.1 Calibration of the Flow Sensor


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

The ventilator will alarm calibrate flow sensor. Press


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

Occlude the flow sensor to


prevent any flow across the

sensor wires.

106
Technical data

15.2 Cleaning and high level disinfection Note: Eliminate all residues of cleaning
of the N5402-REV2 Sensor agents and disinfectant used by thoroughly
rinsing with sterile water after each cleaning
Warning: Do not use any nebulized gases
and disinfecting procedure.
(medications, salt solutions, etc.) in
conjunction with the sensor as they are likely
15.2.3 High level disinfection
to degrade the performance of the sensor and
subsequent displayed accuracies. Autoclave at

134ºC (277ºF) (Allowable variation of temperature


Warning: Before each use the sensor must be of +3ºC) at 220kPa (32psi) with a minimum holding
checked for damage. Damaged parts must not time of 3 minutes.
be used.
or
Remove the flow sensor connecting cable before
any cleaning, high level disinfection. 121ºC (248ºF) (Allowable variation of temperature
of +3ºC) at 96kPa (14.1psi) with a minimum holding
Rinse the sensor body immediately after use and time of 15 minutes.
put it into a disinfectant (recommended by the
infection control authority of the hospital / Note: The sensor must not be connected to
organization), otherwise the sensor will encrust and other standard connectors when autoclaved
cannot be used any more. to prevent cracking. Ensure no other
Flow sensor components/items are lying on the sensor
connecting cble during the autoclaving process.
(Do not autoclave or
immerse in liquids)
ET Manifold port

Flow sensor body


ET tube port

Warning: Do not clean the flow sensor with


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

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


disinfect/high level disinfection the sensor.

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

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

Note: Disinfectants containing compounds


similar to PHENOL or ALKYLAMINES
(Glucorrotamine) are unsuitable.

107
Technical data

16. Technical specification 16.1.2 CMV mode


Respiratory Rate (RR): 1 to 150
16.1 Operating Modes - Conventional Resolution . . . . . . . . 1BPM
Invasive Ventilation Factory set default:. . 30 mbar
This section summarises the specification of the
SLE6000 ventilator in terms of the modes, ranges Inspiratory Time (Ti): 0.1 to 3.0 seconds
alarm limits on the operator adjustable controls and Resolution: . . . . . . . . 0.01 second
their accuracy. It also summarizes the mechanical
and electrical power constraints. PEEP Pressure: . . . . 0 to 35 mbar
Resolution . . . . . . . . 0.5 <10 mbar,
Note: If the ventilator is set to cmH2O via user 1 mbar >10 mbar)
preferences substitute cmH2O for mbar. Factory set default:. . 4 mbar

16.1.1 CPAP mode PIP Pressure: . . . . . . 0 to 65 mbar


Inspiratory Time (Ti): . 0.1 to 3.0 seconds Resolution: . . . . . . . . 1 mbar)
Resolution: . . . . . . . . 0.01 second) Default: . . . . . . . . . . . 15 mbar
Factory set default: . . 0.4 second.
Volume Targeted Ventilation (VTV):
CPAP Pressure (CPAP): 2 to 300 ml
0 to 35 mbar Factory set default: . Set to “Off”
Resolution: . . . . . . . . 0.5 mbar <10mbar, Factory set default: . 3 ml when "On"
1 mbar >10mbar)
Factory set default: . . 4 mbar VTV control, when enabled becomes Vte Target
control.
PIP Pressure: . . . . . . 0 to 65 mbar From 2 ml to 10 ml the parameter increments in 0.2
Resolution: . . . . . . . . 1 mbar) ml steps (Fine resolution)
Factory set default: . . 15 mbar From 10 ml to 100 ml the parameter increments in
1ml steps (Standard resolution).
O2 concentration: . . . 21 to 100% From 100 ml to 300 ml the parameter increments in
Resolution: . . . . . . . . 1% 5ml steps (Coarse resolution).
Factory set default: . . 21%
O2 concentration: . . 21 to 100%
Additional Parameters: Resolution: . . . . . . . . 1%
Apnoea Backup Rate (RR Backup control): Factory set default:. . 21%
1 to 150 BPM
Resolution: . . . . . . . . 1 BPM Additional Parameters:
Factory set default: . . 30 mbar Rise Time: . . . . . . . . 0.0 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second
Rise Time: . . . . . . . . 0.0 to 3.0 seconds Factory set default:. . 0.04 seconds
Resolution . . . . . . . . . 0.01 second
Factory set default: . . 0.04 seconds

Trigger sensitivity with flow sensor


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

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Technical data

16.1.3 PTV mode 16.1.4 PSV mode


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

Inspiratory Time (Ti ): 0.1 to 3.0 seconds Insp.Time (Ti Max):. . 0.1 to 3.0 seconds
Resolution . . . . . . . . . 0.01 second Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.4 second Factory set default:. . 0.4 second

PEEP Pressure . . . . . 0 to 35 mbar PEEP Pressure: . . . . 0 to 35 mbar


Resolution: . . . . . . . . 0.5 mbar <10 mbar, Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar 1 mbar >10mbar)
Factory set default: . . 4 mbar Factory set default:. . 4 mbar

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


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

Volume Targeted Ventilation: Volume Targeted Ventilation:


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

VTV control, when enabled becomes Vte Target VTV control, when enabled becomes Vte Target
control. control.
From 2 ml to 10 ml the parameter increments in 0.2 From 2 ml to 10 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%

Termination Sensitivity (Term Sens control):


5 to 50%
Resolution . . . . . . . . 5%
Factory set default:. . 5%

109
Technical data

16.1.5 SIMV mode Termination Sensitivity (Term Sens control):


Respiratory Rate (RR): 1 to 150 BPM 5 to 50%
Resolution: . . . . . . . . 1 BPM Resolution . . . . . . . . 5%
Factory set default: . . 30 BPM Factory set default:. . 5%
Note: Termination Sensitivity parameter is not
Inspiratory Time (Ti): . 0.1 to 3.0 seconds
shown when pressure support (P Support) is
Resolution . . . . . . . . . 0.01 second off.
Factory set default: . . 0.4 second

PEEP Pressure: . . . . 0 to 35 mbar


Resolution: . . . . . . . . 0.5 mbar <10 mbar, 16.1.6 HFOV mode
1 mbar >10 mbar Frequency: . . . . . . . . 3 to 20 Hz
Factory set default: . . 4 mbar Resolution: . . . . . . . . 0.1 Hz
Factory set default:. . 10 Hz
PIP Pressure: . . . . . . 0 to 65 mbar
Resolution: . . . . . . . . 1 mbar I: E Ratio: . . . . . . . . . 1:1 / 1:2 / 1:3
Factory set default: . . 15 mbar Factory set default:. . 1:1

Volume Targeted Ventilation: MAP:. . . . . . . . . . . . . 0 to 45 mbar


2 to 300 ml Resolution: . . . . . . . . 1 mbar
Factory set default: . . Set to “Off” Factory set default:. . 5 mbar
Factory set default: . . 3 ml when "On"
Delta P Range: . . . . . 4 to 180 mbar
VTV control, when enabled becomes Vte Target Resolution: . . . . . . . . 1 mbar
control. Factory set default:. . 4 mbar
From 2 ml to 10 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:
O2 concentration: . . . 21 to 100% Sigh RR: . . . . . . . . . . 1 to 150 BPM
Resolution: . . . . . . . . 1% Resolution: . . . . . . . . 1 BPM
Factory set default: . . 21% Factory set default: . Set to “Off”
Factory set default: . 30 BPM when "On"
Additional Parameters:
Rise Time: . . . . . . . . . 0.0 to 3.0 seconds Sigh Ti control: . . . . . 0.1 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.1 second Factory set default:. . 0.4 second

P Support: . . . . . . . . . 0 to 65 mbar Sigh P control: . . . . . 0 to 45 mbar


Factory set default: . . Set to “Off” Resolution: . . . . . . . . 1 mbar
Factory set default: . . 8 mbar when "On" Factory set default:. . 20 mbar

Trigger sensitivity with flow sensor


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

110
Technical data

16.1.7 HFOV+CMV mode 16.2 Operating Modes Conventional Non


Respiratory Rate (RR): 1 to 150 BPM Invasive Ventilation
Resolution: . . . . . . . . 1 BPM
16.2.1 nCPAP D mode (Dual Limb)
Factory set default: . . 30 BPM
Inspiratory Time (Ti):. 0.1 to 3.0 seconds
Inspiratory Time (Ti): . 0.1 to 3.0 seconds Resolution: . . . . . . . . 0.01 second
Resolution: . . . . . . . . 0.01 second Factory set default:. . 0.40 second
Factory set default: . . 0.40 second
CPAP Pressure: . . . . 0 to 35 mbar
Frequency Range:. . . 3 to 20Hz Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar
Resolution: . . . . . . . . 0.1Hz
Factory set default:. . 4 mbar
Factory set default: . . 10Hz.
PIP Pressure: . . . . . . 0 to 65 mbar
PEEP Pressure: . . . . 0 to 35 mbar
Resolution: . . . . . . . . 1mbar
Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar Factory set default:. . 15mbar

PIP Pressure: . . . . . . 0 to 65 mbar O2 concentration: . . 21 to 100%


Resolution: . . . . . . . . 1 mbar Resolution: . . . . . . . . 1%
Factory set default: . . 15 mbar Factory set default:. . 21%

Delta P Range: . . . . . 4 to 180 mbar Additional Parameters:


Resolution: . . . . . . . . 1 mbar RR Backup control: . 1 to 150 BPM
Factory set default: . . 4 mbar Resolution: . . . . . . . . 1 BPM
Factory set default: . Set to “Off”
O2 concentration: . . . 21 to 100% Factory set default: . 40 BPM when "On"
Resolution: . . . . . . . . 1%
Factory set default: . . 21% Rise Time: . . . . . . . . 0.0 to 3.0 seconds
Resolution: . . . . . . . . 0.01 second
Additional Parameters: Factory set default:. . 0.1 second
HFO Activity: . . . . . . . Oscillation on both high and
low cycles. Trig Sens: . . . . . . . . . 1% to 100%
Oscillation on low cycle only. Resolution: . . . . . . . . 1%
Oscillation Pause: . . . 60 seconds Factory set default:. . 50%

111
Technical data

16.2.2 NIPPV D mode (Dual Limb) 16.2.3 nHFOV D mode (Dual Limb)
Respiratory Rate (RR): 1 to 150 BPM Frequency: . . . . . . . . 3 to 20Hz
Resolution: . . . . . . . . 1 BPM Resolution: . . . . . . . . 0.1Hz
Factory set default: . . 30 BPM Factory set default:. . 10 Hz

Inspiratory Time (Ti): . 0.1 to 3.0 seconds I: E Ratio: . . . . . . . . . 1:1 / 1:2 / 1:3
Resolution: . . . . . . . . 0.01 second Factory set default:. . 1:1
Factory set default: . . 0.40 second
Mean airway pressure (MAP control):
0 to 45 mbar
PEEP Pressure: . . . . 0 to 35 mbar
Resolution: . . . . . . . . 1 mbar
Resolution: . . . . . . . . 0.5 mbar <10 mbar,
1 mbar >10 mbar Factory set default:. . 5 mbar
Factory set default: . . 4 mbar
Delta P Range: . . . . 4 to 180 mbar
PIP Pressure: . . . . . . 0 to 65 mbar Resolution: . . . . . . . . 1 mbar
Resolution: . . . . . . . . 1 mbar) Factory set default:. . 4 mbar
Factory set default: . . 15 mbar
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: Sigh RR: . . . . . . . . . . 1 to 150 BPM
Rise Time: . . . . . . . . . 0.0 to 3.0 seconds Resolution: . . . . . . . . 1 BPM
Resolution: . . . . . . . . 0.01 second Factory set default: . Set to “Off”
Factory set default: . . 0.04 second Factory set default: . 30 BPM when "On"

Sigh Ti control: . . . . . 0.1 to 3.0 seconds


Resolution: . . . . . . . . 0.01 second)
Factory set default:. . 0.4 second

Sigh P control: . . . . . 0 to 45 mbar


Resolution: . . . . . . . . 1 mbar
Factory set default:. . 20 mbar

112
Technical data

16.2.4 nCPAP S mode (Single Limb) 16.3 Mode of operation


Inspiratory Time (Ti): . 0.1 to 3.0 seconds The ventilator is designed for continuous operation.
Resolution: . . . . . . . . 0.01 second
Factory set default: . . 0.50 second 16.4 Controls

CPAP Pressure: . . . . 2 to 15 mbar 16.4.1 Power Button


Resolution: . . . . . . . . 0.5 mbar <10 mbar, The ON/OFF button has an integrated LED to
1 mbar >10 mbar indicate status of the ventilator, where:
Factory set default: . . 4 mbar “LED Off” means the unit is off and no mains power
is connected to the system,
PIP Pressure: . . . . . . 2 to 25 mbar
Resolution: . . . . . . . . 1mbar “Green” colour means unit is on and ready to use,
Factory set default: . . 10mbar “Amber” colour means the ventilator is off, mains
power is connected and the internal batteries are
O2 concentration: . . . 21 to 100% fully charged,
Resolution: . . . . . . . . 1%
“Flashing Amber” colour means the ventilator is off,
Factory set default: . . 21% the mains power is connected and the internal
batteries are charging;
Additional Parameters:
RR Backup control: . . 1 to 10 BPM 16.4.2 User Interface
Resolution: . . . . . . . . 1 BPM The SLE6000 is fitted with a colour display with a
Factory set default: . . Set to “Off” screen resolution of 1024 by 768 pixels.
Factory set default: . . 10 BPM when "On" The screen size is 12.1” with an LED backlight.
Trig Sens: . . . . . . . . . 1% to 100% The touch screen is a 5 wire resistive type suitable
Resolution: . . . . . . . . 1% for operation whilst wearing medical gloves.
Factory set default: . . 50% 16.4.2.1 Buttons
The following buttons are accessible via the touch
screen.

16.2.5 O2 therapy (Single Limb) Button Description


Flow Rate: . . . . . . . . . 2 to 30 l/min Opens the mode tabs
Mode
Resolution: . . . . . . . . 0.1 l/min Single press to select or cancel
Factory set default: . . 8 l/min.
Open the alarm tabs
Alarms Single press to select or cancel
O2 concentration: . . . 21 to 100%
Resolution: . . . . . . . . 1% Opens the utilities tabs
Utilities Single press to select or cancel
Factory set default: . . 21%
Opens the layout tabs
Layout Single press to select or cancel

Opens the mode tabs


Start / Resume ventilation
Single press to select

Opens the utilities tabs


Calibration & Utilities
Single press to select

Locks the screen


Lock Screen
Single press to select

Unlock the screen


Touch and hold for 1 second

Reset the active alarm or


Reset clears an alarm message
Single press to select

113
Technical data

Button Description Button Description


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

Selects PTV mode Selects the night screen


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

114
Technical data

Button Description Button Description

Selects the waveforms - Decrease setting


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

Selects 15 mm patient circuit


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

Opens the selected layout Additional


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

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

F/V
Selects the flow/volume loop
Single press to select
Activates an oscillatory sigh
Selects the flow/pressure Sigh Single press to select
F/P loop
Single press to select
Selects the volume/pressure Activates an oscillatory sigh
V/P loop hold
Single press to select Single press to select. or button can
Sigh
be held for a a maximum of 5 or 10
Selects the trend drop down seconds depending on user set
menu preference.
Single press to select
Activates an oscillatory
Oscillation
pause.
Confirm setting button Pause
Press and hold for 2 seconds
Single press to select
Pauses the waveforms
Single press to select
Cancel/Exit button Press and hold for 1 second to
Single press to select Si h activate screen capture.

Activates the trend zoom Releases the paused


Zoom function waveforms
Single press to select
Single press to select or cancel
Press and hold for 1 second to
Si h
Cursor Activates the trend cursor activate screen capture.
Single press to select or cancel Save screen capture to
Activates the trend scroll memory
Scroll function Press and hold for 3 seconds to
Single press to select or cancel activate screen capture

Number keys 0 to 9
+ Increase setting
Single press to select
1 Single press to select

115
Technical data

Button Description Tabs Description


Backspace - Cancels input Sensors tab
Single press to select Sensors Tab allows access to sensor
calibration tab.
Back button - returns to Single press to select
<< Back previous tabs
Single press to select Brightness tab
Brightness Tab allows access to screen
Alarm audio pause brightness adjustment tab.
Single press to select or cancel Single press to select
System tab
System Tab allows access to system
functions tab.
Single press to select
Data tab
Data Tab allows access to data tab.
Single press to select

16.4.2.3 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
Range 0.1 - 3.0 seconds
16.4.2.2 Tabs
Single press to select or cancel
The following Tabs are available via the touch 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
Tab allows access to Non-invasive Range 0.0 - 35 mbar
Non-Invasive Single press to select or cancel
modes.
Single press to select mbar

Standby mode tab


Tab allows access to Standby mode. PIP
Standby Standby mode only active when
PIP control
ventilating. Range 1 - 65 mbar
Single press to select Single press to select or cancel
mbar
Limits tab
Tab allows access to alarm limits.
Limits O2
Alarm limits only active when
Oxygen % control
ventilating.
Range 21 - 100 %
Single press to select
Single press to select or cancel
History tab %
History Tab allows access to alarm history.
Single press to select RR Backup
RR Backup (Respiratory
Loudness tab rate) control
Loudness Tab allows access to alarm Range 1 - 150 BPM
loudness adjustment tab. Single press to select or cancel
Single press to select BPM

116
Technical data

Controls Description Controls Description


Rise Time Sigh RR Sigh RR (Sigh respiratory
Rise time control rate) control
Range 0 - 3 seconds Range 1 - 150 BPM
Single press to select or cancel Press and hold for 2 seconds to
Seconds BPM select

Trig Sens Trig Sens (Trigger sensitivity) Sigh Ti


Sigh Ti (Sigh inspiratory
control time) control
Range 1 - 20 l/min with flow sensor
Range 0.1 - 3.0 seconds
Range 1 - 100 % without flow sensor
Single press to select or cancel Single press to select or cancel
l/min seconds

RR Sigh P Sigh P (Sigh pressure)


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

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

VTV (Volume targeted


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

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

∆P
∆P (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

Frequency
Frequency control
Range 3 - 20 Hz
Single press to select or cancel
Hz

I:E I:E (Inspiratory to expiratory


ratio) control
Range 1:1, 1;2 & 1:3
Single press to select or cancel
Ratio

117
Technical data

16.5 Measurement 16.5.6 Measured parameters


Leak
16.5.1 Flow sensor
Measurement range: 0-99%
Flow Sensor Type: . . 10 mm dual-hot-wire
Resolution: . . . . . . . . 1%
anemometer.
Percentage leak measured around ET tube (when
Applied part: . . . . . . . Type BF
using an un-cuffed tube). The difference between
Flow Rate: . . . . . . . . . 0.2 l/min to 30 l/min the expired volume compared to the inspired
Accuracy: . . . . . . . . . ±8 % maximum volume as a percentage and averaged over 5
Dead space: . . . . . . . 1 ml breaths. A calculated value.
Weight: . . . . . . . . . . . 10 g
Value smoothed with a filter (time constant equal to
16.5.2 Flow 10 breaths).
Flow Rate: . . . . . . . . 0 l/min to 99 l/min Respiratory Rate (RR)
Resolution: . . . . . . . . 0.1 l/min Measurement range: 0 to 999 BPM
Resolution: . . . . . . . . 1 BPM
16.5.3 Volume
Total number of breaths detected by the ventilator.
Expiratory Tidal Volume:
(Mechanical and patient triggered). A measured
0 to 999 ml (0.1 ml)
value.
Expiratory Minute Volume:
0 to 18 L Compliance (C)
Resolution: . . . . . . . . 1 ml Measurement range: 0 to 99.9 ml/mbar
Resolution: . . . . . . . . 1ml/mbar
16.5.4 Volume controlled breath accuracy Compliance is the ratio of the change in lung
Volume volume to change in the applied pressures. A
Maximum Bias error: . . . .±3 ml calculated value. Value smoothed with a filter (time
Maximum linearity error: .±8 % constant equal to 3 breaths).
Typical: . . . . . . . . . . . . . .±8 % C20/C:
PEEP Measurement range: 9999
Maximum Bias error: . . . .±1 mbar Resolution . . . . . . . . 1
Maximum linearity error: .±18 % Sampling Time: . . . . 2ms
Typical: . . . . . . . . . . . . . .±1 mbar Is the ratio of the compliance during the last 20% of
Oxygen the respiratory cycle to the total compliance. A
Maximum Bias error: . . . .±3 % calculated value. Value smoothed with a filter (time
Maximum linearity error: .±0.5 % constant equal to 3 breaths).
Typical: . . . . . . . . . . . . . .±3 % Resistance (R)
Measurement range: 0 to 999 mbar l/second
16.5.5 Pressure controlled breath accuracy
Resolution . . . . . . . . 1
PIP
Resistance of the patient lung to flow The total
Maximum Bias error: . . . .±1 mbar
change in the applied pressure to the patient lung
Maximum linearity error: .±11 % divided by the peak expiratory flow from the lung. A
Typical: . . . . . . . . . . . . . .±1 mbar measured value.
PEEP
Value smoothed with a filter (time constant equal to
Maximum Bias error: . . . .±1 mbar
3 breaths).
Maximum linearity error: .±18 %
Typical: . . . . . . . . . . . . . .±1 mbar Inspiratory time (Ti)
Oxygen Measurement range: 0 to 9.99 seconds
Maximum Bias error: . . . .±3 % Resolution: . . . . . . . . 10 milliseconds
Maximum linearity error: .±0.5 % The measured inspiratory time, where the breath
Typical: . . . . . . . . . . . . . .±3 % may be flow or volume terminated and therefore
shorter than the set inspiratory time.

118
Technical data

Expiratory time (Te) 16.5.6.2 Pressure


Measurement range: . 0 to 9.99 seconds
Resolution: . . . . . . . . 10 milliseconds Peak Pressure: . . . . 0 to 999mbar
The measured expiratory time, Total respiratory rate Resolution: . . . . . . . . 0.1 mbar
minus the Inspiratory time. A calculated value. Accuracy: . . . . . . . . . ±0.75% of full scale
A measured value
Vmin (l)
Measurement range: . 0 to 99.99 l PEEP Pressure: . . . 0 to 999 mbar
Resolution: . . . . . . . . 0.01 l Resolution: . . . . . . . . 0.1 mbar
Minute volume is the accumulated expiratory tidal Accuracy: . . . . . . . . . ±0.75% of full scale
volume over a one-minute period. A measured A measured value
value in litres per minute.
Mean Pressure: . . . . -999 to 999 mbar
Trigger (Trig)
Resolution: . . . . . . . . 0.1 mbar
Resolution: . . . . . . . . 1 Accuracy: . . . . . . . . . ±0.75% of full scale
The number of patient triggered breaths (updated A measured value
every 2 seconds). A measured value.
Vte (ml) Delta P:
Mean Pressure: . . . . 9 to 999 mbar
Measurement range . 0 to 99.9 ml
Resolution: . . . . . . . . 1 mbar
Resolution: . . . . . . . . 0.1 ml
In HFO combined mode Delta P is measured during
Expired volume of large and small breaths. A
expiration only. A measured value.
measured value in millilitres. Value smoothed with a
filter (time constant equal to 3 breaths). Above values are obtained under ATPD (ambient
DC02 temperature and pressure, dry) conditions.

Measurement range . 0 to 9999


Resolution . . . . . . . . . 1 16.5.6.3 Sound pressure level
Is a gas transport coefficient. A calculated value Sound pressure level: 49 dBA
based on tidal volume and frequency. Value Sound power level:. . 53 dBA
smoothed with a filter (time constant equal to 3
breaths). 16.5.6.4 Exhalation Block Port Jet Sizes
Reverse or negative jet:
I:E Ratio Ø 1.45/1.5 mm
Forward or positive jet:
Measurement range . 1:9.9 or 9.9:1
Ø 1.25/1.3 mm
Resolution . . . . . . . . . 0.1
Mean or 3rd jet: . . . . Ø 0.60/1.0 mm
Inspiratory to Expiratory ratio. A calculated value
derived from the user set inspiratory time against
the time divided by the user set BPM minus the
inspiratory time.

16.5.6.1 Oxygen Concentration


Measurement range: 0% to 999%
Resolution: . . . . . . . . 1%
Accuracy: . . . . . . . . . ±3%
Response time: . . . . . 45 seconds

119
Technical data

16.5.7 BS EN ISO 80601-2-12 Disclosure 16.6 Patient circuits


Volume controlled breaths Ø 10 mm . . . . . . . . . BC6188
As per the above standard, Clause 201.12.1.101 Resistance:. . . . . . . . @15 l/min 1.5 mbar
Volume-controlled breath type, maximum Resistance:. . . . . . . . @30 l/min 6 mbar
inaccuracies are contained within the tolerances Compliance: . . . . . . . 1.89 ml/kPa/m
stated in Section 16.5.2 of this document. Inspiratory and expiratory pressure drop
With reference to Note 3 of Clause 201.12.1.101 30 l/min. . . . . . . . . . . 11.24 mbar
15 l/min. . . . . . . . . . . 3.69 mbar
Intentionally, for some of these tests, i.e., those with
5 l/min. . . . . . . . . . . . 0.8 mbar
a large compliance and a large resistance, the end
expiratory flow will not reach zero. 2.5 l/min . . . . . . . . . . 0.38 mbar

In these cases the actual delivered volume and the


Ø 10 mm . . . . . . . . . BC6188/DHW
value in table 201.103 (within BS EN ISO 80601-1-
12) the following differences are recorded: Resistance:. . . . . . . . @15 l/min 1.5 mbar
Resistance:. . . . . . . . @30 l/min 6 mbar
Volumes of 50 ml and the O2% set to 60% (Circuit Compliance: . . . . . . . 1.89 ml/kPa/m
compliance 3 ml/hPa, resistance 200 hPa/l/s, BPM
Inspiratory and expiratory pressure drop
30 and Ti of 0.6 sec.) inaccuracy rises to ±12%.

PEEP at volumes of 20 ml and the O2% set to 30% 30 l/min. . . . . . . . . . . 11.24 mbar
(Circuit compliance 1 ml/hPa, resistance 200 hPa/l/ 15 l/min. . . . . . . . . . . 3.69 mbar
s, BPM 60 and Ti of 0.4 sec.) inaccuracy rises to
5 l/min. . . . . . . . . . . . 0.8 mbar
±38%.
2.5 l/min . . . . . . . . . . 0.38 mbar
Pressure controlled breaths

As per the above standard, Clause 201.12.1.102 Ø 15 mm . . . . . . . . . BC6198


Volume-controlled breath type, maximum Resistance:. . . . . . . . @15 l/min 0.3 mbar
inaccuracies are contained within the tolerances Resistance:. . . . . . . . @30 l/min 1.0 mbar
stated in Section 16.5.2 of this document. Compliance: . . . . . . . 3.72 ml/kPa/m
With reference to Note 3 of Clause 201.12.1.102 Inspiratory and expiratory pressure drop
30 l/min. . . . . . . . . . . 2 mbar
Intentionally, for some of these tests, i.e., those with 15 l/min. . . . . . . . . . . 0.64 mbar
a large compliance and a large resistance, the end
5 l/min. . . . . . . . . . . . 0.15 mbar
expiratory flow will not reach zero.
2.5 l/min . . . . . . . . . . 0 mbar
In these cases the actual delivered volume and the
value in table 201.104 (within BS EN ISO 80601-1- 16.7 Breathing system filters
12) the following differences are recorded:
16.7.1 N3029
PIP at 15 mbar and the O2% set to 30% (Circuit Filtration Efficiency: . BFE 99.999% VFE 99.999%
compliance 20 ml/hPa, resistance 20 hPa/l/s, BPM Resistance @ 60 l/min: < 380 pa
20 and Ti of 1 sec.) inaccuracy rises to ±11%.
Dead space: . . . . . . . 99 ml
PEEP at 5 mbar and the O2% set to 30% (Circuit Connections: . . . . . . 22M/15F-22F/15M
compliance 3 ml/hPa, resistance 50 hPa/l/s, BPM Weight: . . . . . . . . . . . 40gm
30 and Ti of 0.6 sec.) inaccuracy rises to ±34%. Autocalve cycles: . . . 5
16.5.8 Measurement uncertainties 16.7.2 N3587
Below are listed the measurement uncertainties for Filtration Efficiency: . BFE 99.999% VFE 99.999%
following monitored variables:
Resistance @ 30 l/min: 60 pa
Flow. . . . . . . . . . . . . . . . .±2% Dead space: . . . . . . . 30 ml
Pressure . . . . . . . . . . . . .±0.5% Connections: . . . . . . 22M/15F-22F
Oxygen concentration . . .±2% Weight: . . . . . . . . . . . 23gm

16.8 Maximum limited Pressures


Conventional PLIM . . . 120 mbar (single fault
condition)

120
Technical data

16.9 Gas supplies 16.11 Power, Dimensions, Classification


The air and oxygen high pressure gas supplies are
16.11.1 Power AC
used as fresh gas.
Mains Voltage: . . . . . 100-240V/ 50-60Hz Power:
16.9.1 Oxygen supply 115 VA
The ventilator requires a supply of medical grade Fuse: . . . . . . . . . . . . T2.5AH 250V (5x20mm)
oxygen between 2.8 to 6 bar. (Qty 2)
The ventilator will typically run for over 3 hours from
16.9.2 Air supply 100% battery charge to complete discharge, both in
The ventilator requires a supply of medical grade conventional and HFO modes. Actual battery
compressed air to ISO8573.1 Class 1.4.1 (minimum discharge duration will depend on battery condition
level of filtration) between 2.8 to 6 bar and ventilation settings applied.

Recommended level of filtration is class 1.1.1. Battery Back up:

Description of Class 1.4.1 1= particle size of 0.1 Mode 100% to 25% 50% to 25%
microns. 4 = Pressure dewpoint of +3 ºC. 1= oil Standby 130 40
content 0.01mg/m3
CMV 120 35
Description of Class 1.1.1 1= particle size of 0.1
microns. 1 = Pressure dewpoint of -70 ºC. 1= oil HFO+CMV 105 30
content 0.01mg/m3 NIPPV 120 35
If the compressed air supply is found to fall below All times are in minutes.
the ISO8573.1 standard then in-line filtration of the Battery Charging: . . Full charge 18 Hours 80%
air is required. charge 8 hours
16.9.2.1 Connectors 16.11.2 Power DC
P/Nº Z6000/NST Voltage: . . . . . . . . . . 24V 4A (Requires a medical
Air connector . . . . . . . NIST (ISO 18082:2014) grade power supply)
Oxygen connector . . . NIST (ISO 18082:2014) Connector: . . . . . . . . EN3 series 2. 2 way male
P/Nº Z6000/DIS connector. (Switchcraft
Air connector . . . . . . . DISS EN32F16X)
Oxygen connector . . . DISS
16.12 Operating Environment
16.9.3 Flows Temperature: . . . . . . +10ºC to +40ºC
Variable Fresh Gas Flow: Relative Humidity: . . 10 to 90% (Non condensing)
2 to 30 l/min Ambient pressure: . . 620 hPa (4000m) to 1060
Resolution: . . . . . . . . 1l/min hPa (Sea level)
Maximum gas flow: . . 85 l/min Size, Ventilator only:. 330 mm W x 369 mm H x 548
Resolution: . . . . . . . . 1 l/min mm D
Nebulizer flow:. . . . . . 7 l/min Height on pole: . . . . . 1140 mm
Resolution: . . . . . . . . 1l/min Weight (ventilator): . . 20Kg
Note: The ventilator maintains the accuracy of
16.10 Service life controlled and displayed variables when
operating within the above stated limits of
The SLE6000 has a 10 year service life from the temperature, humidity and ambient pressure.
date of commissioning.
16.12.1 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

121
Technical data

16.13 Classification (Electrical) 17. Outputs ports (Electrical)


Type of protection against electric shock: Class I.
17.1 RS232 port
Degree of protection against electric shock: Type
BF applied part. 17.1.1 SLE6000 basic data output.
The SLE6000 basic data output is the default
Unit must be earthed.
protocol used to output data from the ventilator to an
external medical monitor.
16.14 GMDN classification number
GMDN: . . . . . . . . . . . 14361 The data is a comma delimited ASCII string of 58
device parameters.
16.15 IP rating
17.1.2 SLE6000 basic data output Specifications
Type of protection against ingress of water: IP21 SLE6000 basic data output contains a Header, Data
First digit 2: Protected against solid foreign objects and Footer format.
of 12,5 mm in diameter and greater Header Data Footer
Second digit 1: Protection against vertically falling Device ID, 58 Parameters, Comma CRC, Carriage
water drops. Version, separated Return, Line
Pressure Units, Feed
Number of
16.16 Environmental Storage Conditions Parameters
When packed for transport or storage;
The data is output at a fixed baud rate, with no parity
Ambient Temperature: bits or hardware handshaking in use. The protocol is
-20°C to +50°C a unidirectional protocol and does not require a
Relative Humidity: . . . 10% to 90% non-condensing response from the connected medical monitor. The
Atmospheric Pressure:620 hPa (4000m) to 1060 protocol does not allow for transmission of data by
hPa (Sea level) the medical display monitor; any data received by
the SLE6000 ventilator will be ignored.

17.1.3 Communications Settings


The SLE Protocol is transmitted using an RS232
format, with a fixed baud rate. The communication
interface uses the following RS232 settings:
Setting Type Value
Baud Rate 19,200 bps
Parity None
Data Bits 8
Stop Bits 1
Data Format ASCII Text String
Flow Control None

17.1.3.1 Data Rate & Size


The transmission of the data string begins every 1
second. The maximum size of each ASCII string is
512 bytes.

122
Technical data

17.1.3.2 Data Format defined limit and scaling. Each parameter is output
Data within the SLE6000 basic data output is in integer format.
implemented as a comma delimited ASCII string
format. All valid data is represented using The validity of each parameter is checked before
alphanumeric characters. Characters are used to transmission by the SLE6000 ventilator.
represent data which is out of range or invalid for a
different reason and will be used in place of the Note: If the Pressure Units parameter is
parameter value. unknown, then all pressure related
parameters are replaced by the invalid data
Character(s) Use case Description character.
‘?’ Invalid data Data which is
unknown or has Nº Name Description Units Output Range
timed out will be (Physical range)
replaced by ‘?’.
1 RR Set Breaths/ 1 – 150,
‘-‘ Data is out of range Each data has an Respiratory min 0 if RR backup is
associated range. Rate OFF.
Data which is out of (Breaths per
this range is minute).
replaced by ‘-‘
2 CPAP Set CPAP 0.1 * 0 – 350
‘,’ Separation of value. pressure (0 – 35 mbar)
parameters units 0 – 357
<CR><LF> End of output string Carriage return, (0 – 35.7 cmH20)
Line Feed. Used to 3 Tidal Set Target 0.2ml 10 – 1500
indicate the end of a Volume Tidal Volume (2 – 300ml)
data transmission
4 Ti Set Target 0.01s 10 – 300
inspiratory (0.10 – 3.00s)
17.1.4 Data Layout time
An example of the output is shown below. The 5 PIP Set PIP Pressur 0 – 65(mbar)
header and footer sections are shown in bold the Pressure e Unit 0 – 66 (cmH2O)
data is in italics. (1 mbar
or 1
cmH2O)
6 O2 Set Oxygen % 21 – 100
Concentratio
n
7 HFO Delta P Set HFO Pressur 4 – 180 mbar
Delta P e Unit 4 – 183 cmH20
8 HFO MAP Set HFO Pressur 0 – 45
Mean e Unit (mbar or cmH2O)
Pressure
Header Format 9 HFO Set HFO 0.1Hz 30 – 200 (3 –
Frequency Rate 20Hz)
Parameter Name Description Value
10 Sigh RR Backup Breaths/ 1-150,
Ventilator ID Unique to each type of SLE6000 Respiratory min ‘-‘ if sigh cycling is
ventilator. i.e. “SLE6000” rate in HFO not enabled.
Version ID Protocol Version ID V2.0 mode
Pressure Units The units of all displayed ‘0’ - mbar, 11 Sigh Ti Inspiratory 0.01s 10 – 300
pressure values. mbar or ‘1’ - cmH2O time in HFO (0.10 – 3.00s),
cmH2O mode, for ‘-‘ if sigh cycling is
Sigh breaths not enabled.
Parameter The number of 58
Number parameters output. 12 Sigh P Pressure Pressur 0 – 60mbar (0-
applied in e unit 61cmH2O),
Sigh ‘-‘ if sigh cycling is
Footer Format
breaths, not enabled.
HFO mode.
Description Number of Characters Range
CRC Value 4 0000 – FFFF
Carriage Return 1 <CR> (0x0D)
Line Feed 1 <LF> (0x0A)

17.1.5 Data Format


The data contains 58 parameters which are
outputted in a fixed order. Each parameter has a

123
Technical data

13 Ventilation n/a n/a Uses the Breath 23 High PEEP High PEEP 0.1*Pres 50 – 450
Mode mode Alarm alarm sure (5.0 – 45.0 mbar)
enumerated list: threshold. Unit 50 – 459
CPAP = 0 (5.0 – 45.9
CMV = 1 cmH2O)
PTV =2
24 Cycle Fail / Low 0.1 * 0 – 1150
PSV = 3
Low PIP inspiratory Pressur (0 – 115 mbar)
SIMV =4 alarm phase e Unit 0 – 1172
HFO only = 6
pressure (1 – 117.2
HFO + CMV = 7
alarm cmH20)
nCPAP D= 9 threshold.
NIPPV D = 10
SNIPPV D = 11 25 High PIP Value to 0.1 * 100 – 1200
NHFOV D = 12 Alarm trigger a Pressur (10 – 120mbar)
NCPAP S =13 high e Unit 100 – 1223
NIPPV S =14 pressure (10 – 122.3
SNIPPV S = 15 alarm cmH20)
O2 Therapy = 16 26 Low tidal Value to 0.1ml 0 – 2970
Standby = 17 volume trigger a low (0 – 297ml)
14 VTV Status N/A N/A 0 = OFF. alarm tidal volume
255 = ON. alarm
15 Termination Set % of % 0 – 50 27 High tidal Value to 0.1ml 30 – 3000
Sensitivity breath volume trigger a (3 – 300ml)
5-50
maximum alarm high tidal
flow which volume
If ’-‘ = OFF
triggers alarm
breath 28 Low minute Value to ml 0 – 17900
termination. volume trigger the (0 – 17.9l)
16 Breath Target 0.1l/min 2 – 200 alarm minute
Trigger trigger for low (0.2 – 20 l/min for volume
Threshold threshold triggerin flow triggering. alarm (low)
g. 1 – 100% for 29 High minute Value to ml 1000 – 18000
If Pressure volume trigger the (1l – 18l)
Pressur Triggering) alarm minute
e volume
triggere alarm (high)
d then
0.5% 30 Low etCO2 Low end etCO2 0 - 145
Alarm tidal CO2 Units (as
17 Rise Time Time taken 10ms 0 – 300 concentratio shown in
for pressure (0.00 – 3.00s) n alarm paramet
curve to er 54)
reach 99%
of the target 31 High etCO2 High end etCO2 5 -150
pressure Alarm tidal CO2 Units (as
concentratio shown in
18 Set Flow Expiratory 0.1 l/min 50 – 3000 n alarm paramet
(O2 Mode) port flow (5.0 – 300.0 l/ er 54)
whilst in O2 min)
support 32 Low spO2 Low spO2 % 1 – 98
mode. Alarm Concentratio
n Alarm
19 Nebuliser Nebuliser is ON/OFF 255 = ENABLED
Enabled connected 0 = DISABLED. 33 High spO2 High spO2 % 2 – 98
and Alarm Concentratio
enabled. n Alarm

20 Patient Leak Leak alarm % 10 – 50 34 Low Pulse Low pulse Beats/ 30 – 230
alarm value 5-50= ON. Rate Alarm rate alarm min
‘-‘ = OFF 35 High Pulse High pulse Beats/ 35 - 235
Rate Alarm rate alarm min
21 Apnoea Time taken Seconds 5 – 60
Alarm to trigger the 36 Measured Total breath Breaths/ 0 – 255
apnoea RR count over min
alarm (Respiratory the last
Rate) minute
22 Low Value to 0.1 * -1200 – 1100
pressure trigger a low Pressur (-120 – 110mbar) 37 Measured Measured 0.1 mbar - 1750 – 1750
alarm pressure e Unit -1223 – 1121 CPAP CPAP value (-175 – +175
alarm (-122.3 – 112.1 mbar)
cmH20) -1784 – 1784
(-178.4 – 178.4
cmH20)

124
Technical data

38 Measured Ti Measured 0.01s 0 – 32767 50 Compliance Measured 0.1 ml/ 0 – 255 (0.0 –
inspiratory (0 – 327.67 s) dynamic mbar 25.5 ml/mbar)
time. airway (0.1 ml/ 0 – 250 (0.0 –
39 Measured Measured 0.1ml 0 – 32767 compliance Pressur 25.0 ml/cmH20)
e Unit)
Vinsp inspiratory (0 – 3.2767l)
volume 51 C20/C The ratio of 0.1 0 – 255 (0 – 25.5)
40 Measured Measured 0.1ml 0 – 32767 the
compliance
Vte expiratory (0 – 3.2767l)
over the last
volume
20% of the
41 Measured Measured 0.1 * - 1750 – 1750 pressure rise
PEEP PEEP value Pressur (-175 – +175 compared to
e Unit mbar) total
-1784 – 1784 (- compliance
178.4 – 178.4
cmH20) 52 DCO2 Gas 1 0 – 32000
transport
42 Measured Measured 0.1 * - 1750 – 1750 coefficient
PIP PIP value Pressur (-175 – +175
53 etCO2 Measured mmHg, 0 - 255
e Unit mbar)
End tidal Volume
-1784 – 1784 (-
178.4 – 178.4 CO2 Percent
pressure age, kPa
cmH20)
43 Oxygen Measured % 0 – 100 54 etCO2 Units etCO2 N/A 0 = mmHg,
Pressure 1 = Volume
Concentrati oxygen
Units Percentage,
on concentratio
n as a % of 2 = kPa
the air 55 SpO2 Oxygen 0.1% 0 – 1000 (0.0 –
composition saturation 100.0%)
44 Measured The Pressur - 1750 – 1750 56 Pulse Rate Pulse rate Beats/ 0 - 239
HFO Delta P difference e Unit (-175 – +175 minute
between mbar)
57 CO2 Carbon mmHg 0 – 2000 (0.0 –
maximum -1784 – 1784 (-
Dioxide 200.0mmHg)
and 178.4 – 178.4 partial
minimum cmH20)
pressure
pressures in
HFO mode. 58 Alarm The current N/A See Alarm Table
Status active alarm.
45 Measured Measured 0.1* - 1750 – 1750
HFO MAP HFO mean Pressur (-175 – +175
pressure e Unit mbar)
-1784 – 1784 (-
178.4 – 178.4
cmH20)
46 Trigger Number of Breaths/ 0 – 255
Count breaths min
triggered by
the patient in
the last
minute
47 Measured Measured ml 0 – 32767 (0 –
Minute volume 32.767l)
Volume change in
the last
minute
48 Leak Measured % % 0 – 100
of air leaking
from the
system
49 Resistance Measured 0.1 0 – 32767
airway (mbar or (0 – 3276.7
resistance mmH20) mbar.s/l)
.s/litre 0 – 32767
( 0 – 3341.4
cmH20.s/l)

125
Technical data

Alarm Table 64 No Gas.


Alarm 68 Hardware Fault 14
Alarm Description
Code 71 Hardware Fault 7
1 Hardware Fault 15 72 Hardware Fault 6
2 The oxygen cell needs calibrating. 75 Hardware Fault 18
3 A new oxygen cell is required. 80 Sub Ambient Pressure - 1
4 Hardware Fault 16 81 Sub Ambient Pressure - 2
5 High Oxygen Level. 82 Flow Sensor Clipping
6 Low Oxygen level. 83 Flow Sensor Reversed
15 Hardware Fault 8 90 Unexpected Rise in Mean Pressure
16 High Pressure Threshold Exceeded. 91 Unexpected Drop in Mean Pressure
17 Low Pressure 96 Pressure change detected.
18 Apnoea 97 Unexpected Rise in Delta Pressure.
19 Cycle Fail. 98 Unexpected Drop in Delta Pressure.
20 Continuing Positive Pressure 99 High Paw
21 High CPAP 100 Hardware Fault 17
22 High PEEP 106 Hardware Fault 4
23 High PIP 114 Hardware Fault 2
24 Low PIP 115 Hardware Fault 3
25 Hardware Fault 11 116 Hardware Fault 9
26 Hardware Fault 12 117 Hardware Fault 5
27 Hardware Fault 13 120 High respiratory rate
28 Calibrate Flow Sensor.
29 Unable to calibrate flow sensor.
30 Flow sensor is not connected.
31 Flow sensor is defective.
32 Flow sensor is contaminated.
40 Hardware Fault 1
41 Hardware Fault 19
45 Battery low.
46 Main Power Fail.
47 Hardware Fault 10
48 Battery low.
50 High minute volume
51 Low minute volume
52 Low tidal volume
53 High Patient Leak.
54 Apnoea
55 Breath Not Detected.
56 High tidal volume
60 Blocked Fresh Gas.
61 Leaking Fresh Gas.
62 No O2 Supply
63 No Air Supply

126
Technical data

17.2 Nurse call 17.6 External Monitor


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

When connected to a hospital nurse call system the Warning. An external monitor should not be
ventilator will generate an activation signal on the connected to the ventilator when being used
following alarm conditions: clinically. The external monitor should only be
used for demonstrations or training
Condition 1. Any high priority alarm (Patient & purposes.
Technical)

Condition 2. A monitor system failure

Condition 3. A total power failure or shutdown of the


ventilator.

When the high priority alarm is cleared the


activation signal for the nurse call system is
cancelled.

Pressing the ventilators ON/OFF button shall


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

Note: For alarm condition 3 the duration of


the alarm activation signal is approximately 2
to 9 minutes.

17.2.1 Nurse call delay


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

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

17.4 USB (Data)


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

17.5 USB (Power)


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

127
Technical data

18. Inputs ports (Electrical)


18.1 SPO2 and EtCO2
The SPO2 and EtCO2 are non-functional in this
release of software.

Both SPO2 and EtCO2 devices are type BF applied


parts.

18.2 Flow sensor


The flow sensor is a type BF applied part.

18.3 DC 24V
This port is to allow an external 24V 4A direct power
supply to be connected.

Caution: Use only a medical grade 24V DC


power supply with a current rating of 4A.

128
Technical data

19. Alarms 19.1.3 Alarm log


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

The alarm signals generated by the alarm system 19.2 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 2Hz 30% on
any alarm that have been triggered the alarm
Medium
volume level is set to its minimum setting, for a Yellow 0.6Hz 30% on
priority
period of 10 seconds. After the 10 seconds has
expired the alarm loudness will returns to the user Constant
Low priority Cyan 100% on
set value. (On)

The operator can inactivate nuisance generation of


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

Note: In the event of a mains power fail


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

19.1.1 Alarm Characteristics


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

The High priority alarm signal consists of 10 pulses.


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

The Medium priority alarm signal consists of 3


pulses followed by a 20 second gap.

The Low priority alarm signal consists of 2 pulses,


alarm is not repeated.

19.1.2 Alarm sounder volume


High priority alarm: 72 dBA

Medium priority alarm: 72 dBA

Low priority alarm: No low priority alarms

129
Technical data

A Low Tidal volume ............................................ 147


A new oxygen cell is required. ........................ 151
Apnoea ............................................................ 149 M
Main Power Fail. ............................................. 150
B Minute volume below low threshold. ............... 148
Battery low. ..................................................... 142
Blocked Fresh Gas. Check patient circuit. ...... 143 N
Breath Not Detected. ...................................... 148 No Air Supply .................................................. 141
No Gas ............................................................ 135
C No O2 Supply .................................................. 141
Calibrate Flow Sensor. .................................... 145
Continuing Positive Pressure .......................... 136 P
Cycle Fail. ....................................................... 138 Power supply faulty ......................................... 156
Pressure change detected. ............................. 138
F
Flow Sensor Clipping ...................................... 146 S
Flow sensor is contaminated. ......................... 145 Sub Ambient Pressure - 1 ............................... 133
Flow sensor is defective. ................................. 144 Sub Ambient Pressure - 2 ............................... 133
Flow sensor is not connected. ........................ 145
Flow Sensor Reversed .................................... 146
T
The oxygen cell needs calibrating. .................. 150
H Total power fail ................................................ 153
Hardware Fault 1 ............................................ 131
Hardware Fault 10 .......................................... 142
U
Hardware Fault 11 .......................................... 143
Unable to calibrate flow sensor. ...................... 145
Hardware Fault 12 .......................................... 144
Unexpected Drop in Delta Pressure ................ 140
Hardware Fault 13 .......................................... 144
Unexpected Drop in Mean Pressure ............... 140
Hardware Fault 14 .......................................... 146
Unexpected Rise in Delta Pressure ................ 140
Hardware Fault 15 .......................................... 150
Unexpected Rise in Mean Pressure ................ 139
Hardware Fault 16 .......................................... 151
Hardware Fault 17 .......................................... 152
Hardware Fault 18 .......................................... 152
Hardware Fault 19 .......................................... 153
Hardware Fault 2 ............................................ 132
Hardware Fault 20 .......................................... 131
Hardware Fault 21 .......................................... 131
Hardware Fault 3 ............................................ 132
Hardware Fault 4 ............................................ 134
Hardware Fault 5 ............................................ 134
Hardware Fault 6 ............................................ 135
Hardware Fault 7 ............................................ 135
Hardware Fault 8 ............................................ 139
Hardware Fault 9 ............................................ 141
High Minute Volume ........................................ 147
High Oxygen Level. ......................................... 151
High Patient Leak. ........................................... 147
High Paw ......................................................... 136
High PEEP ...................................................... 139
High PIP .......................................................... 137
High Pressure Threshold Exceeded. .............. 136
High Respiratory Rate. .................................... 149
High Tidal volume ........................................... 148

L
Leaking Fresh Gas. Check patient circuit. ...... 143
Low Oxygen Level. ......................................... 152
Low PIP ........................................................... 137
Low Pressure .................................................. 138

130
Technical data

19.2.0.1 Alarm table

Alarm message: Hardware Fault 21. Remove ventilator from service!


Alarm condition: User interface error (comms) Alarm type: Technical
Active in all modes Alarm ranking: 0
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the user interface can no longer communicate to the monitor or
controller subsystems.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: Hardware Fault 20. Remove ventilator from service!


Alarm condition: Monitor failure Alarm type: Technical
Active in all modes Alarm ranking: 0
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the user interface can no longer communicate to the monitor
subsystem.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: Hardware Fault 1. Remove ventilator from service!


Alarm condition: Alarm generator error Alarm type: Technical
Active in all modes Alarm ranking: 0
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: No
Definition: This alarm is generated whenever the monitor sub system fails to communicate with the alarm
controller. The monitor sub system will attempt to communicate 5 times before initiating the alarm.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

131
Technical data

Alarm message: Hardware Fault 2. Remove ventilator from service!


Alarm condition: Power supply communication error Alarm type: Technical
Active in all modes Alarm ranking: 1
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated whenever the monitor sub system fails to communicate with the power
supply. The monitor sub system will attempt to communicate 5 times before initiating the alarm.
Ventilator action: Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: Hardware Fault 3. Remove ventilator from service!


Alarm condition: Power supply faulty Alarm type: Technical
Active in all modes Alarm ranking: 2
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated whenever the power supply indicates it is in a fault state. See “Hardware
Fault 3. (Power supply fault table)” on page 154.

A fault code has been returned by the PSU


Incorrect PSU type.
One or both batteries are faulty.
The batteries are imbalanced.
One or both batteries are under 14.6V.
One or both batteries are not of the correct type.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

132
Technical data

Alarm message: Sub Ambient Pressure - 2


Alarm condition: Sub ambient Phase 2 Alarm type: Patient
Active in all modes Alarm ranking: 3
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: When the proximal pressure falls below -2mbar for greater than 50ms a “Sub ambient Pressure”
alarm is generated.
Ventilator action: When the monitor subsystem detects the proximal pressure falls below -2mbar for greater
than 50ms it instructs the controller sub-system to shut off all gasses. If the gas are not cut off during the next
50ms the monitor subsystem intervenes and cuts off the gasses.
User action: Check Patient. Check Patient circuit. If alarm persists transfer the patient to an
alternative form of ventilation. Withdraw ventilator from service. Route ventilator for repair.

Alarm message: Sub Ambient Pressure - 1


Alarm condition: Sub ambient Phase 1 Alarm type: Patient
Active in all modes Alarm ranking: 4
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: When the proximal pressure falls below -2mbar for less than 50ms a “Sub ambient Pressure”
alarm is generated.

Ventilator action: When the monitor subsystem detects the proximal pressure falls below -2mbar for less
than 50ms it instructs the controller sub-system to shut off all gasses. If the gas are not cut off during the next
50ms the monitor subsystem intervenes and cuts off the gasses.
User action: Check Patient. Check Patient circuit. If alarm persists transfer the patient to an
alternative form of ventilation. Withdraw ventilator from service. Route ventilator for repair.

133
Technical data

Alarm message: Hardware Fault 4. Remove ventilator from service!


Alarm condition: Monitor memory Fault Alarm type: Technical
Active in all modes Alarm ranking: 5
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: Stored calibration values have been corrupted. This check only done on start-up. The values can
only be cleared by turning the ventilator OFF.
The nature of the alarms can be read in from the alarm history tab (Limit field).
See “Hardware Fault 4. (Monitor memory fault table)” on page 154.
Flow calibration values have been corrupted
Oxygen calibration values have been corrupted
Pressure offset calibration values have been corrupted
Pressure gain calibration values have been corrupted
Pressure time constant calibration values have been corrupted
Unable to send calibration data to the isolated side
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: Hardware Fault 5. Remove ventilator from service!


Alarm condition: ADC VREF specification Alarm type: Technical

Active in all modes Alarm ranking: 6


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: ADC 2V5 REF is out of spec by at least 20%
Other ADC errors are also returned in the alarm history tab (Limit field).
The values can only be cleared by turning the ventilator OFF.
See “Hardware Fault 5 & 9. (Local voltage monitor fail fault table)” on page 156.
2V5 REF (This message will trigger this alarm)
8V Standby error (This message will not trigger this alarm)
5V Sounder error (This message will not trigger this alarm)
3V3 error (This message will not trigger this alarm)
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

134
Technical data

Alarm message: Hardware Fault 6. Remove ventilator from service!


Alarm condition: Control hardware fault Alarm type: Technical

Active in all modes Alarm ranking: 7


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: A number of controller faults are grouped together under this alarm. The nature of the alarms can
be read in from the alarm history tab (Limit field). See “Hardware Fault 4. (Monitor memory fault table)” on
page 154.
Fresh gas module self-test has failed
Blender module self-test has failed
Breath jet module self-test has failed
Controller not responding
Controller has reset.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: Hardware Fault 7. Remove ventilator from service!


Alarm condition: Control UI not responding Alarm type: Technical
Active in all modes Alarm ranking: 8
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: The controller subsystemsends life-ticks at regular intervals to the monitor subsystem. If they are
interrupted for more than a prescribed time it is assumed that the controller sub-system is not functioning
properly and the “Controller Failure.” alarm is generated. Any system error message received from the
controller will also activate this alarm.
Ventilator action: If a control subsystem failure occurs, operation of all valves is switched off. Without the
power applied to the valves a fresh gas flow of 1.8l/min of air is available for spontaneous breathing. The
monitor subsystem shall recognise that the controller is no longer responding to status requests and shall
raise an alarm. If the controller resets itself it will stop ventilation.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: No Gas


Alarm condition: Gas not connected Alarm type: Technical

Active in all modes Alarm ranking: 9


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No
Definition: This alarm is generated by the controller subsystem indicating that both air and oxygen supplies
have dropped below 2 bar.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation.

135
Technical data

Alarm message: Continuing Positive Pressure


Alarm condition: Continuing Pressure Alarm type: Patient
Active in all modes except O2 therapy Alarm ranking: 10
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the pressure remains more than 5mBar above the user set CPAP level for 4 seconds this alarm
is generated. In pure HFO mode this alarm is generated when the measured mean is more than 15mbar
above the captured mean or 15mbar above the received alarm threshold.
Ventilator action: In conventional modes, if the pressure rises more than 5mbar above the user set pressure
or the continuing positive pressure condition is recognised then the monitor will raise an alarm and instruct
the controller to stop ventilation. If this fails the monitor subsystem intervenes and stops ventilation.
User action: Check Patient. Check Patient circuit. If alarm persists transfer the patient to an
alternative form of ventilation. Withdraw ventilator from service. Route ventilator for repair.

Alarm message: High Pressure Threshold Exceeded.


Alarm condition: High pressure Alarm type: Patient
Active in all modes except O2 therapy Alarm ranking: 11
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: In conventional modes, if the maximum pressure rises more than 5mbar above the high PIP
pressure threshold the monitor will raise an alarm and instruct the controller to stop
ventilation. If this fails the monitor subsystem intervenes and stops ventilation.
Ventilator action: If the pressure is 5mbar above the High PIP threshold a command is sent to the controller
to cut the gas but maintain the PIP.
If the pressure goes 20 mbar above the High PIP threshold the monitor should cut the all the gas off.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High PIP
threshold.

Alarm message: High Paw


Alarm condition: High Paw Alarm type: Patient
Active in HFO, HFO+CMV & NHFOV only. Alarm ranking: 12
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone above the High Paw alarm threshold by no more than 5 mbar.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High Paw
threshold.

136
Technical data

Alarm message: High PIP


Alarm condition: High PIP Alarm type: Patient
Active in all modes except HFO, NHFOV and O2 therapy. Alarm ranking: 13
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone above the High PIP alarm threshold by no more than 5 mbar.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High PIP
threshold.

Alarm message: High CPAP


Alarm condition: High PIP Alarm type: Patient
Active in CPAP mode only Alarm ranking: 14
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone above the High CPAP alarm threshold.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or High CPAP
threshold.

Alarm message: Low PIP


Alarm condition: Low PIP Alarm type: Patient
Active in all modes except HFO, NHFOV and O2 therapy Alarm ranking: 15
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Proximal pressure has gone below the Low PIP alarm threshold during the inspiration cycle.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or Low PIP
threshold.

137
Technical data

Alarm message: Low Pressure


Alarm condition: Low pressure Alarm type: Patient
Active in all modes Alarm ranking: 16
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: If the proximal pressure is below the Low PEEP pressure level this alarm is generated
Ventilator action: If the proximal pressure is below the set Low PEEP/CPAP/Paw pressure level the ventilator
will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or Low PEEP/CPAP/
Paw threshold.

Alarm message: Pressure change detected.


Alarm condition: Pressure MAX Change Alarm type: Patient
Active in HFO+CMV only Alarm ranking: 17
Alarm type: Visual and audible Alarm priority: High
Latching: Yes Alarm mutable: Yes
Definition: Upon a change in the ventilator setting the maximum and minimum pressure during inspiratory
and expiratory phase is captured.
For this alarm to trigger the following conditions must be true:
Condition 1:
1-The captured expiratory maximum pressure must be less than 10mBar
2-The maximum pressure during the inspiration phase differs from the captured value by more than 5mBar.
Condition 2:
2-The maximum pressure during the expiration phase differs from the captured value by more than 5mBar.
Ventilator action: If the conditions for scenario 1 or 2 are met the ventilator will display this alarm message.
User action: User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters or
press Auto Set.

Alarm message: Cycle Fail.


Alarm condition: Fail to cycle Alarm type: Patient
Active in all volume modes. Alarm ranking: 18
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If Targeted volume is active this alarm would be generated if 2 consecutive breaths show a PEEP
and PIP of < 3mbars.

Ventilator action: The ventilator will display this alarm message.


User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

138
Technical data

Alarm message: Hardware Fault 8. Remove ventilator from service!


Alarm condition: Pressure drift Alarm type: Patient
Active in all modes except O2 therapy Alarm ranking: 19
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the readings from the two input pressure transducers differ by more than 5 mbar for more than
0.5 seconds this alarm is generated.

Ventilator action: The ventilator will display this alarm message.


User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: High PEEP


Alarm condition: PEEP too high Alarm type: Patient
Active in all modes except HFO, NHFOV and O2 therapy Alarm ranking: 20
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: Proximal pressure has gone above the High PEEP alarm threshold during the expiratory cycle.

Ventilator action: The ventilator will display this alarm message.


User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Unexpected Rise in Mean Pressure


Alarm condition: Mean Pressure High Alarm type: Patient

Active in HFO and NHFO only Alarm ranking: 21


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the mean proximal pressure is above the set mean pressure by more than 5 mbar this alarm is
generated.

Ventilator action: The ventilator will display this alarm message.


User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

139
Technical data

Alarm message: Unexpected Drop in Mean Pressure


Alarm condition: Mean Pressure Low Alarm type: Patient

Active in HFO and NHFO only Alarm ranking: 22


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the mean proximal pressure is below the set mean pressure by more than 5 mbar this alarm is
generated.

Ventilator action: The ventilator will display this alarm message.


User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Unexpected Rise in Delta Pressure


Alarm condition: Delta Pressure Rise Alarm type: Patient

Active in HFO and NHFO only Alarm ranking: 23


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the minimum and maximum of the proximal pressure increases/ decreases by more than 5 mbar
compared to the captured value this alarm is raised

Ventilator action: The ventilator will display this alarm message.


User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Unexpected Drop in Delta Pressure


Alarm condition: Delta Pressure Drop Alarm type: Patient

Active in HFO and NHFO only Alarm ranking: 24


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

Unused alarm condition


The alarm ranked 25 is not currently used.
Active: NO Alarm ranking: 25

140
Technical data

Alarm message: No O2 Supply


Alarm condition: O2 not connected Alarm type: Technical

Active in all modes Alarm ranking: 26


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: This alarm is generated by the controller subsystem indicating the Oxygen supply has dropped
below 2 bar.
Ventilator action: The ventilator will display this alarm message and continue to operate on the air supply.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: No Air Supply.


Alarm condition: Air not connected Alarm type: Technical

Active in all modes Alarm ranking: 27


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: This alarm is generated by the controller subsystem indicating the Air supply has dropped below 2
bar.
Ventilator action: The ventilator will display this alarm message and continue to operate on the oxygen
supply.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Hardware Fault 9. Remove ventilator from service!


Alarm condition: ADC Voltage spec Alarm type: Technical

Active in all modes Alarm ranking: 28


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: No
Definition: This alarm is generated whenever some of the voltage rails on the monitor board are out of
specification (dropped by more than 20%). The error codes can be read in from the alarm history tab (Limit
field).
See “Hardware Fault 5 & 9. (Local voltage monitor fail fault table)” on page 156.
2V5 REF (This message will not trigger this alarm)
8V Standby error (This message will trigger this alarm)
5V Sounder error (This message will trigger this alarm)
3V3 error (This message will trigger this alarm)
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

141
Technical data

Alarm message: Hardware Fault 10. Remove ventilator from service!


Alarm condition: Power Supply battery integrity Alarm type: Technical

Active in all modes Alarm ranking: 29


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: If the battery is not connected or faulty this alarm is generated


Ventilator action: The ventilator will display this alarm message. In the event of a mains power fail condition
the ventilator will shut down but will provide a flow of fresh gas to assist with spontaneous breathing (1.8 l/
min).
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: Battery low.


Alarm condition: Power supply less than10 minutes left to full Alarm type: Technical
discharge
Active in all modes Alarm ranking: 30
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: This alarm is generated if there is less than 10 minutes to full battery exhaustion.
Ventilator action: The ventilator will display this alarm message and continue to operate.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Battery low.


Alarm condition: Power supply battery low Alarm type: Technical

Active in all modes Alarm ranking: 31


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: This alarm is generated if there is less than 25% capacity.


Ventilator action: The ventilator will display this alarm message and continue to operate.
User action: Transfer the patient to an alternative form of ventilation.

142
Technical data

Alarm message: Blocked Fresh Gas. Check patient circuit.


Alarm condition: Block alarm Alarm type: Patient

Active in all modes Alarm ranking: 32


Alarm type: Visual and audible Alarm priority: High
Latching: No, except in O2 therapy Alarm mutable: No

Definition: This alarm is generated by the controller subsystem indicating that the fresh gas limb of the
patient circuit is blocked.
Ventilator action: The fresh gas pressure is constantly monitored by the controller sub system. This pressure
reading is also continually requested by the monitoring subsystem.
User action: Check Patient circuit.

Alarm message: Leaking Fresh Gas. Check patient circuit.


Alarm condition: Leak alarm Alarm type: Patient

Active in all modes Alarm ranking: 33


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: This alarm is generated by the controller subsystem indicating that the fresh gas limb of the
patient circuit is leaking.
Ventilator action: The ventilator will display this alarm message but attainable PEEP and PIP pressures will
be reduced.
User action: Check Patient circuit.

Alarm message: Hardware Fault 11. Remove ventilator from service!


Alarm condition: Serial communication error Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 34


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: The internal communication error has occurred within the monitor subsystem.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation.

143
Technical data

Alarm message: Hardware Fault 12. Remove ventilator from service!


Alarm condition: Isolate system error Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 35


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: If the configuration data within the isolated side of the monitor subsystem is corrupted this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Hardware Fault 13. Remove ventilator from service!


Alarm condition: Flow ADC unable to calibrate Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 36


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: During monitor subsystem flow calibration, if the signal levels are out of bounds this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation.

Alarm message: Flow sensor is defective.


Alarm condition: Flow sensor defect Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 37


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If one of the flow sensor wires break this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor

144
Technical data

Alarm message: Flow sensor is contaminated.


Alarm condition: Flow sensor is contaminated. Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 38


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If the measured flow is greater than 15 l/minfor 3.5 seconds this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor

Alarm message: Flow sensor is not connected.


Alarm condition: Flow sensor not connected. Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 39


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If the flow sensor is not connected or both wires have been broken this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor

Alarm message: Unable to calibrate flow sensor.


Alarm condition: Unable to calibrate flow sensor Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 40


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If calibrating flow fails for any reason this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Replace flow sensor. If alarm repeats transfer the patient to an alternative form of
ventilation. Withdraw ventilator from service. Route ventilator for repair.

Alarm message: Calibrate Flow Sensor.


Alarm condition: Flow sensor not calibrated Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 41


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: The above alarm is generated whenever the ventilator is turned on or upon the re-connection of
the flow sensor.
Ventilator action: The ventilator will display this alarm message.
User action: Calibrate the flow sensor.

145
Technical data

Alarm message: Flow Sensor Reversed.


Alarm condition: Flow Sensor Reversed Alarm type: Technical

Active in all modes with a flow sensor connected Alarm ranking: 42


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If the flow sensor is placed incorrectly in the circuit or the connecting wire is placed 180 degrees
out of phase to where it should go this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Re-fit flow sensor

Alarm message: Flow Sensor Clipping


Alarm condition: Flow sensor clipped Alarm type: Technical

Active in all modes with a flow sensor connected except HFO Alarm ranking: 43
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the flow through the flow sensor is greater than 30LPM for several breaths this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust ventilatory parameters.

Alarm message: Hardware Fault 14. Remove ventilator from service!


Alarm condition: The user interface has been reset Alarm type: Technical

Active in all modes Alarm ranking: 44


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: If the user interface subsystem resets this alarm is generated.


Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

146
Technical data

Alarm message: High Minute Volume


Alarm condition: High minute volume Alarm type: Patient

Active in all modes with a flow sensor connected except HFO+CMV.


Alarm ranking: 45
Not available in non-invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes
Definition: If the minute volume is higher than the user set high minute volume threshold this alarm is
generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: High Patient Leak.


Alarm condition: Leak Alarm type: Patient

Active in all modes with a flow sensor connected except HFO+CMV,


Alarm ranking: 46
non-invasive modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the calculated patient leak is above the user set alarm threshold this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Low Tidal volume


Alarm condition: Low tidal volume Alarm type: Patient

Active in all modes with a flow sensor connected except non-invasive


Alarm ranking: 47
modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: Tidal volumes higher than the user selected threshold would generate this alarm.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

147
Technical data

Alarm message: High Tidal volume


Alarm condition: High tidal volume Alarm type: Patient

Active in all modes with a flow sensor connected except non-invasive


Alarm ranking: 48
modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: Tidal volumes higher than the user selected threshold would generate this alarm.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Low Minute Volume


Alarm condition: Low minute volume Alarm type: Patient

Active in all modes with a flow sensor connected except non-invasive


Alarm ranking: 49
modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the minute volume is lower than the user-set low minute volume threshold this alarm is
generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Breath Not Detected.


Alarm condition: Apnoea Breath Alarm type: Patient

Active in all modes with a flow sensor connected except non-invasive


Alarm ranking: 50
modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If a breath is not detected within 20 seconds after the ventilator delivers a pressure cycle this
alarm will be generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

148
Technical data

Alarm message: Apnoea


Alarm condition: Apnoea volume Alarm type: Patient

Active in all modes with a flow sensor connected except non-invasive


Alarm ranking: 51
modes and O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If a flow trigger is not detected within the user set apnoea time this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: Apnoea


Alarm condition: Apnoea pressure Alarm type: Patient

Active in all modes without a flow sensor connected. Alarm ranking: 52


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If a pressure trigger is not detected within the user set apnoea time this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

Alarm message: High Respiratory Rate.


Alarm condition: High BPM Alarm type: Patient

Active in invasive CPAP, PTV, PSV, SIMV and non invasive NCPAP
Alarm ranking: 53
dual and single limb. Not available in O2 therapy.
Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: This alarm is generated when the measured total BPM (RR) is more than the user set threshold.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Check Patient circuit. Adjust alarm threshold.

149
Technical data

Alarm message: Main Power Fail.


Alarm condition: Mains failure Alarm type: Technical

Active in all modes Alarm ranking: 54


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: This alarm is generated when the mains voltage is removed from the ventilator.

Ventilator action: The ventilator will display this alarm message and switches to the internal power source.
User action: Restore mains power. Transfer the patient to an alternative form of ventilation.

Alarm message: Hardware Fault 15. Remove ventilator from service!


Alarm condition: Oxygen cell not connected Alarm type: Technical

Active in all modes Alarm ranking: 55


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: A disconnection of the oxygen cell will generate this alarm.


Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for repair.

Alarm message: The oxygen cell needs calibrating.


Alarm condition: Oxygen cell needs calibrating Alarm type: Technical

Active in all modes Alarm ranking: 56


Alarm type: Visual and audible Alarm priority: Medium
Latching: Yes Alarm mutable: Yes

Definition: If at any time the measured oxygen is more than 100% this alarm is generated
Ventilator action: The ventilator will display this alarm message.
User action: Recalibrate the Oxygen. If the message returns transfer the patient to an alternative
form of ventilation. Withdraw ventilator from service. Route ventilator for repair.

150
Technical data

Alarm message: A new oxygen cell is required.


Alarm condition: Oxygen cell needs replacing Alarm type: Technical

Active in all modes Alarm ranking: 57


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If the oxygen cell could not be calibrated during a calibration point this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for cell replacement.

Alarm message: Hardware Fault 16. Remove ventilator from service!


Alarm condition: Oxygen solenoid failure Alarm type: Technical

Active in all modes Alarm ranking: 58


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: Yes

Definition: If during 100% oxygen calibration the oxygen solenoid fails to activate this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for cell replacement.

Alarm message: High Oxygen Level.


Alarm condition: Oxygen too high Alarm type: Technical

Active in all modes Alarm ranking:59


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the delivered oxygen is higher than the set oxygen level by more than 5% this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Recalibrate the Oxygen. If the message returns transfer the patient to an
alternative form of ventilation. Withdraw ventilator from service. Route ventilator for repair.

151
Technical data

Alarm message: Low Oxygen Level.


Alarm condition: Oxygen too low Alarm type: Technical

Active in all modes Alarm ranking:60


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: Yes

Definition: If the delivered oxygen is lower than the set oxygen level by more than 5% this alarm is
generated.
Ventilator action: The ventilator will display this alarm message.
User action: Check Patient. Recalibrate the Oxygen. If the message returns transfer the patient to an
alternative form of ventilation. Withdraw ventilator from service. Route ventilator for repair.

Alarm message: Hardware Fault 17. Remove ventilator from service!


Alarm condition: Can Display Congestion Alarm type: Technical

Active in all modes Alarm ranking: 61


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: If the data cannot be sent to the user interface subsystem this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for cell replacement.

Alarm message: Hardware Fault 18. Remove ventilator from service!


Alarm condition: ESMO hardware fault Alarm type: Technical

Active in all modes Alarm ranking: 62


Alarm type: Visual and audible Alarm priority: Medium
Latching: No Alarm mutable: No

Definition: ESMO not responding. The ESMO sub-system is to send life-ticks at regular intervals to the
monitor. If the above life ticks are interrupted for more than a prescribed time it will be assumed that the
ESMO sub-system is not functioning properly
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for cell replacement.

152
Technical data

Alarm message: Hardware Fault 19. Remove ventilator from service!


Alarm condition: Nurse call error Alarm type: Technical

Active in all modes Alarm ranking: 63


Alarm type: Visual and audible Alarm priority: High
Latching: No Alarm mutable: No

Definition: The nurse call relay is checked upon activation and deactivation. If it is found not to be in a correct
state this alarm is generated.
Ventilator action: The ventilator will display this alarm message.
User action: Transfer the patient to an alternative form of ventilation. Withdraw ventilator from
service. Route ventilator for cell replacement.

Alarm Sound: Continuous


Alarm condition: Total power failure Alarm type: Technical

- Alarm ranking: 64
Alarm type: Audible only Alarm priority: High
Definition: When all internal power is exhausted this alarm is sounded.
Ventilator action: The ventilator will sound this alarm until the unit is turned off or the alarm power supply is
exhausted.
User action: Transfer the patient to an alternative form of ventilation.

153
Displayed

9
8
7
6
5
4
3
2
1

11

44
43
42
41
40
39
38
37
36
35
34
33
32
31
30
29
28
27
26
25
24
23
22
21
20
19
18
17
16
15
14
13
12
10
alarm Nº
One or both batteries

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
are not of the
correct type
One or both batteries

X
X
X
X
X
X
X
X
X
X
X
X
X
X
fault table)

are under 14.6V.

The batteries are

X
X
X
X
X
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
batteries are faulty.

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

Incorrect PSU type

A fault code has


19.3 Hardware Fault 3. (Power supply

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

been returned by
the PSU

154
Displayed Displayed

9
8
7
6
5
4
3
2
1
Technical data

11

15
14
13
12
10
63
62
61
60
59
58
57
56
55
54
53
52
51
50
49
48
47
46
45

alarm Nº alarm Nº

Unable to send calibration One or both batteries

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

data to the isolated side are not of the


correct type
Pressure time constant One or both batteries
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

fault table)
calibration values have been
are under 14.6V.
corrupted.
Pressure gain calibration The batteries are

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

values have been corrupted imbalanced

Pressure offset calibration One or both

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

values have been corrupted batteries are faulty.

Oxygen calibration

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

Incorrect PSU type


values have been corrupted

Flow calibration values A fault code has

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

have been corrupted been returned by


19.4 Hardware Fault 4. (Monitor memory

the PSU
Displayed

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

Unable to send calibration

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
data to the isolated side
Pressure time constant

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

Pressure offset calibration

X
X
X
X
X
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
X
X
X
X
X
X

values have been corrupted

Flow calibration values

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

have been corrupted

155
Displayed Displayed
Technical data

63
62
61

7
6
5
4
3
2
1

23
22
21
20
19
18
17
16

151
150
149
148
147
146
145
144
135
134
133
132
131
130
129
128
alarm Nº alarm Nº

Unable to send calibration


X
X
X

Controller
table)

data to the isolated side

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
reset
Pressure time constant
X
X
X

calibration values have been


Controller not

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
corrupted.
responding
Pressure gain calibration
X
X
X

values have been corrupted


Breath jet

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

module Pressure offset calibration


X
X
X

values have been corrupted


Blender

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

Oxygen calibration
X
X

module
values have been corrupted

Fresh gas Flow calibration values

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

19.5 Hardware Fault 6. (Controller fault

module have been corrupted


Technical data

19.6 Hardware Fault 5 & 9. (Local voltage


monitor fail fault table)

8V standby error

8V standby error

VREF error
Displayed

3V3 error
alarm Nº

1 X
2 X
3 X X
4 X
5 X X
6 X X
7 X X X
8 X
9 X X
10 X X
11 X X X
12 X X
13 X X X
14 X X X
15 X X X X

156
Technical data

20. Cleaning and disinfection 6 Unlock the exhalation


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

Note: All other accessories not listed here


can be cleaned in accordance with local
hospital guideline.
7 Gently pull away the
Components that can are in the gas pathway and exhalation block and
can become contaminated are: silencer from the gas
ports.
Exhalation block
Silencer
Gas jet ports
Occlusion valve

The ventilator’s external surface includes the back


surface of the ventilator, the screen, the metal plate 8 Separate the silencer
at the bottom of the ventilator, the metal cover and and exhalation block.
the moulded case.


Detachable components are: the exhalation block


and silencer.

20.1 Instructions
Before cleaning or disinfecting the exterior of the 20.2 External surface cleaning
ventilator the following tasks should be performed: instructions
1 Disconnect the mains cable from the mains 1 Obtain three clean, disposable, absorbent non-
supply. shedding cloths.

2 Remove the patient circuit and bacterial filters. 2 Prepare a mild purpose detergent solution/ hand
Discard any single use items as per appropriate hot water in a clean container.
hospital authority guidelines. Reusable items 3 Wipe the ventilator’ external surface using mild
should be processed as per appropriate hospital general purpose detergent solution/hand hot
authority guidelines and the manufacturers’ water with the first cloth.
instructions.
4 If detergent was used for step 3, remove the
3 Disconnect the gas supplies from the wall detergent from the ventilator’ external surface
outlets. using the second cloth with water only.
4 Disconnect the Oxygen and Air hoses from the 5 Wipe the ventilator’s external surface dry using
ventilator and cap the inlet ports. the third cloth.
5 Open the side flap.

157
Technical data

20.3 External surface disinfection 2 Pour Alcohol (70% isopropanol) in a container.


instructions 3 Dampen one of the cloths in the Alcohol (70%
1 Obtain two clean, disposable, absorbent non- isopropanol).
shedding cloths.
4 Wipe the two jet ports
2 Pour Alcohol (70% isopropanol) in a container. with the alcohol-
wetted cloth.
3 Dampen one of the cloths in the Alcohol (70%
isopropanol). 5 Wipe the dry using
the second cloth.
4 Wipe the ventilator’s external surface with the
alcohol-wetted cloth.
5 Wipe the ventilator’s external surface dry using
the second cloth.
OR 20.8 Occlusion valve
If the occlusion valve
6 Wipe the ventilator’s external surface using which is internally
Alcohol (70% isopropanol) wipes. mounted is deemed to
7 Allow to dry. have been contaminated
it can only be cleaned by
20.4 Exhalation block cleaning a service technician as it
instructions requires ventilator
disassembly.
1 Prepare a mild purpose detergent solution/ hand
hot water in a clean container.
2 Wash the exhalation block in the mild general
purpose detergent solution / hand hot water. 20.9 Cleaning of main air intake filter.
1 Remove the fan filter guard (1). No tool required.
3 Rinse with sterile water.
4 Allow to dry.

20.5 Exhalation block disinfection


instructions
1 Pour Alcohol (70% isopropanol) in a container,  2
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. 1
4 Autoclave with pure dry saturated steam at
134°C at 220kPa with a minimum holding time of
3 minutes or 121°C at 96kPa with a minimum
holding time of 15 minutes.

20.6 Silencer disinfection instructions


1 Autoclave with pure dry saturated steam at
134°C at 220kPa with a minimum holding time of
3 minutes or 121°C at 96kPa with a minimum
holding time of 15 minutes. 2 Remove the filter (2).
3 Wash the filter (2) in clean water.
Note: The silencer can be autoclaved up to 25
times. Mark the silencer with an autoclavable Warning. Do not wring or deform the filter as
marker after each autoclave cycle to indicate this will cause it to loose its shape.
the number of autoclave cycles completed.
4 Dry the filter (2) between paper towels until no
20.7 Gas jet ports disinfection moisture is left.
1 Obtain two clean, disposable, absorbent non- 5 Replace the filter (2) and filter guard (1).
shedding cloths.

158
Troubleshooting

21. Troubleshooting Chart


21.1 Ventilation Related Problems

Warning: In all alarm conditions check


the patient first.

Symptom Possible Cause Remedy

Alarm Message: Fresh gas supply tube blocked or Check the fresh gas supply line and
Blocked Fresh Gas. kinked. rest of the patient circuit.
Check patient circuit.
10mm circuit fitted but ventilator
invasive mode set to 15mm patient
circuit.

Patient circuit leaking fresh gas. Check the fresh gas supply line and
Alarm Message: rest of the patient circuit plus water
Leaking Fresh Gas. trap.
Check patient circuit.
15mm circuit fitted but ventilator
invasive mode set to 10mm patient
circuit.

Alarm Message: Constriction of proximal airway line. Remove constriction.


Continuing positive
pressure.

Alarm Message: Waveform has crossed high pressure Check ventilator pressures.
High Pressure alarm threshold.
threshold exceeded. Check the patient circuit.

Alarm Message: Waveform has crossed cycle fail alarm Check ventilator pressures.
Cycle Fail. threshold.
Check the patient circuit and water
trap.

Waveform has crossed low pressure Check ventilator pressures.


Alarm Message: alarm threshold. Check the patient circuit and water
Low Pressure. trap.
Adjust alarm threshold.

Alarm Message: The mean pressure has increased by Check ventilator pressures.
Unexpected rise in more than 5mbar. Check the patient circuit.
mean 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 by more than 5mbar. Check the patient circuit.
delta pressure. Press autoset to for new alarm
thresholds.

159
Troubleshooting

Symptom Possible Cause Remedy

Alarm Message: The maximum pressure has Check ventilator pressures.


Unexpected Drop in decreased by more than 5mbar. Check the patient circuit and water
Delta Pressure. trap.
Press autoset to for new alarm
thresholds.

Alarm Message: Flow sensor has become encrusted Remove sensor from patient circuit.
Flow sensor is with secretions. Fit new flow sensor and calibrate.
contaminated. Refit sensor into patient circuit.
If no replacement sensor available
press “Continue without flow” and set
breath trigger sensitivity.

Alarm Message: The minute volume trend has crossed Check ventilator pressures.
High Minute Volume. the high minute volume alarm Check the patient circuit.
threshold. Set new alarm threshold.

Alarm Message: The minute volume trend has crossed Check ventilator pressures.
Low Minute Volume. the low minute volume alarm Check the patient circuit.
threshold. Set new alarm threshold.

Alarm Message: The calculated percentage of patient Check the patient circuit.
High Patient Leak. leak has crossed the alarm threshold. Set new alarm threshold.

Alarm Message: The tidal volume waveform has Check the patient.
Low Tidal Volume. crossed the low tidal volume alarm Check the patient circuit and water
threshold. trap.
Set new alarm threshold.

Alarm Message: A breath has not been detected by the Set new breath detection threshold or
Apnoea. ventilator. breath trigger sensitivity.

Check the patient circuit.

Alarm Message: ET tube blocked or disconnected. Check the patient for air entry.
Breath Not Detected. Check the patient circuit.

Preview mode cancels. The preview mode self cancels after Re-select preview mode.
120 seconds if no button presses are
made.

160
Troubleshooting

21.2 Ventilator Related Problems

Warning: In all alarm conditions check


the patient first.

Symptom Possible Cause Remedy

Ventilator screen Display failure. Refer ventilator to qualified service


remains blank on power personnel.
up. Power button halo is
green.

Ventilator screen blank Display failure. Remove patient to alternative form of


with alarm tone being ventilation, then remove ventilator
generated. Ventilator from service.
continuing to ventilate.
Refer ventilator to qualified service
personnel.

Ventilator screen blank. Complete power failure. Remove patient to alternative form of
Power button halo is Off. ventilation, then remove ventilator
Continuous alarm tone from service.
being generated.

Touchscreen buttons do Touching the screen at two points. Touch the screen at one point only
not operate as expected.
Touchscreen out of alignment. Refer ventilator to qualified service
personnel.

Touchscreen buttons do Touchscreen failure. Remove patient to alternative form of


not operate. ventilation, then remove ventilator
from service.

Refer ventilator to qualified service


personnel.

Total power fail alarm Power button not re-pressed on power Re-press button fully to cancel alarm.
active (Audible only) down.
after turning off the
ventilator.

Alarm Message: No Air and Oxygen supplies not Check Air and Oxygen
Gas. connected to ventilator. supplies/connections.

Air and Oxygen supply failed. If generated whilst connected to a


patient, remove patient to alternative
form of ventilation.

Leaking fresh gas alarm Air and Oxygen supply failed. If generated whilst connected to a
with CPAP/PEEP/Mean patient, remove patient to alternative
at zero and PIP/Delta P form of ventilation.
at zero.
Alarm Message: Check Air and Oxygen
Leaking Fresh Gas. supplies/connections.
Check patient circuit.

161
Troubleshooting

Symptom Possible Cause Remedy

Low pressure alarm with Air and Oxygen supply failed. If generated whilst connected to a
CPAP/PEEP/Mean at patient, remove patient to alternative
zero and PIP/Delta P at form of ventilation.
zero.
Alarm Message: Check Air and Oxygen
Low Pressure. supplies/connections.

Alarm Message: Oxygen supply not connected to Check Oxygen supply/connections.


No O2 Supply. ventilator.
If generated whilst connected to a
Oxygen supply failed. patient, remove patient to alternative
form of ventilation.

No Air supply alarm. Air supply not connected to ventilator. Check Air supply / connections.
Alarm Message:
No Air Supply. Air supply failed. If generated whilst connected to a
patient, remove patient to alternative
form of ventilation.

Battery fault alarm. The internal battery has failed or the Remove ventilator from service.
Alarm Message: power supply has developed a fault. Note alarm message and refer
Battery Fault. ventilator to qualified service
personnel.

Battery Low alarm. Battery has reached 25% charge level. Restore mains power.
Alarm Message: If mains power cannot be restored,
Battery Low. remove patient to alternative form of
(Medium priority) ventilation.
Note alarm message and refer
ventilator to qualified service
personnel.

Battery Low alarm. Battery has reached 10 minute Restore mains power.
Alarm Message: operation. If mains power cannot be restored,
Battery Low. remove patient to alternative form of
(High priority) ventilation.
Note alarm message and refer
ventilator to qualified service
personnel.

Pressure sensor drift A pressure sensor transducer has Remove ventilator from service.
alarm. failed an internal system check. If generated whilst connected to a
Alarm Message: patient, remove patient to alternative
Hardware fault 8. form of ventilation
remove ventilator from Note alarm message and refer
service. ventilator to qualified service
personnel.

162
Troubleshooting

Symptom Possible Cause Remedy

Alarm Message: Faulty A flow sensor heated wire has broken. Remove sensor from patient circuit.
Flow Sensor. Discard the flow sensor.
Fit new flow sensor and recalibrate.

Refit sensor into patient circuit.


If no replacement sensor available
press “Continue without flow” and set
breath trigger sensitivity.

If message continues, remove patient


to alternative form of ventilation, then
remove ventilator from service.
Note alarm message and refer
ventilator to qualified service
personnel.

Alarm Message: Flow sensor cable not connected to Connect flow sensor cable and
Connect Flow Sensor. ventilator. recalibrate flow sensor. Refit sensor
into patient circuit. If to be used
without sensor press “Continue
without flow” and set breath trigger
sensitivity.

If sensor connected, both heated wires Remove sensor from patient circuit.
broken. Discard the flow sensor.
Fit new flow sensor and recalibrate.
Refit sensor into patient circuit.
If no replacement sensor available
press “Continue without flow” and set
breath trigger sensitivity.

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.
Hardware fault 14. If generated whilst connected to a
remove ventilator from patient, remove patient to alternative
service. 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
Hardware fault 15. disconnected. ventilation, then remove ventilator
remove ventilator from from service.
service. 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.

163
Troubleshooting

Symptom Possible Cause Remedy

Oxygen calibration During the oxygen sensor calibration Remove patient to alternative form of
failure. the ventilator could not achieve a ventilation, then remove ventilator
Alarm Message: reading of 100% oxygen. from service.
Hardware fault 16.
remove ventilator from Note alarm message and refer
service. ventilator to qualified service
personnel.

Monitor/Display Comms A hardware/software fault has Remove patient to alternative form of


fail alarm. developed within the ventilator. ventilation, then remove ventilator
Alarm Message: from service.
Hardware fault 17. Note alarm message and refer
remove ventilator from ventilator to qualified service
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 c) Remove the patient immediately to
threshold exceeded. or an alternative form of ventilation.
Low Pressure.
d) Remove the ventilator from service
and refer ventilator to qualified service
personnel.

164
Functional testing

22. Planned preventative 22.2.2 Kit B


Proportional valve kit (3 valves) Qty. 1
Maintenance (PPM)
High speed valve assembly Qty. 1
Warning. Planned preventative Maintenance
of this ventilator should only be carried out Each PPM kit will require the installation of the
by a SLE trained hospital engineer or an SLE above parts and a re-calibration.
service engineer.
22.3 Kit part numbers
22.1 PPM schedule Kit A N9610/A
Kit B N9610/B
Year Use PPM Use PPM
A service manual is available for use by
KIt A kit B*
qualified engineers who have been trained by
1 A SLE on this product.

2 A The service manual contains full illustrated


parts list, circuit diagrams, pneumatic
3 A diagrams and calibration procedure for the
ventilator.
4 A
Contact SLE or your distributor for further
5 A
information.
6 A B*
22.4 Mains cable replacement
7 A
Warning. The replacement of the mains cable
8 A should only be carried out by a SLE trained
9 A hospital engineer or an SLE service engineer.

10 A Remove the two screws (A) to release the clamp


(B).

*Note: Kit B shall be used at 6 years or 30,000


hours, which ever is sooner. The time in C
hours should be taken from the hour counter

mounted in the rear of the pneumatic chassis.

The hour counter only records the time the


ventilator is in operation i.e. turned on.

22.2 PPM kits B


The SLE6000 has two PPM kits, A & B.


22.2.1 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:M0255/95
“O” rings Qty. 2
Mains cable 3M long Shuko plug. P/Nº:M0255/96
Orifice block “O” rings Qty. 2
Particulate filters 5μm Qty. 2 Mains cable 3M long NEMA plug. P/Nº:M0255/97

165
Functional testing

23. Functional testing 7 Set the O2 control to 25%.


Functional testing can be performed if the user 8 Disconnect the oxygen supply. (The ventilator
wants to check the operation of the alarms or the will now switch to 100% air).
basic performance of the ventilator.
9 The loss of oxygen supply alarm will now
Functional testing is broken down into two sections,
trigger (Message “No O2 supply”).
alarm testing and performance testing.
10 Disconnect the air supply
23.1 Alarm testing
11 The loss of gas supply alarm will now trigger
The alarm test routine allows the user to test the
(Message “No Gas”).
essential performance of the following alarms:
12 Reconnect both gases.
Alarm type Alarm message
High Oxygen High oxygen level 23.1.2 Obstruction alarm - Blocked fresh gas
Low Oxygen Low oxygen level 1 Still in CMV mode remove the inspiratory
supply line and obstruct the “Fresh gas to
PEEP alarm CPAP to high/
Patient” port.
PEEP to high
2 Press the reset button until the “Blocked fresh
Obstruction alarm Blocked fresh gas
Gas” alarm appears.
Partial occlusion alarm Continuing positive 3 Reconnect the inspiratory supply line and reset
pressure all alarm messages.
Expired volume alarm Tidal volume above
high threshold 23.1.3 Partial occlusion alarm - Continuing
positive pressure
Low volume alarm Minute volume
below low threshold 1 Change mode to CPAP

Power supply failure alarm Main power fail 2 Gently constrict the exhalation limb tube to
increase the measured pressure to just under
Loss of gas supply alarm No air supply the high PIP alarm threshold. Ensure that the
No O2 supply pressure waveform does not cross the High
High Pressure alarm High pressure PIP alarm threshold.
threshold exceeded 3 The partial occlusion alarm will now trigger,
1 Use the standard ventilator set up as described (Message “Continuing positive pressure”)and
in “Ventilator basic setup” on page 22. the gases will be cut.
Note: The CPAP to high alarm will be
2 Connect a full patient circuit and test lung.
triggered first but will then be overridden
Warning: The patient circuit used for by the Continuing positive pressure
functional testing must not be used for alarm
patient ventilation.
4 Release the constriction from the exhalation
3 Select and enter CMV mode. limb tube.
4 Ensure that the oxygen system has completed
23.1.4 High Pressure alarm - High pressure
its calibration.
threshold exceeded
23.1.1 High Oxygen/Low Oxygen/Loss of gas 1 Block the proximal airway line by creating a
supply alarm test folding the line over.
1 Set the O2 control to 21%. 2 The pressure waveform should increase above
2 Disconnect the Air supply. (The ventilator will the high PIP alarm threshold.
now switch to 100% oxygen). 3 The high pressure alarm will now trigger,
3 The loss of air supply alarm will now trigger (Message “High Pressure Threshold
(Message “No Air Supply”). Exceeded”).

4 Allow the O2 measured value to reach 100%.


5 Reconnect the Air supply.
6 The High oxygen alarm (Message “High
Oxygen level”) will be triggered.

166
Functional testing

23.1.5 Expired volume alarm - Tidal volume 6 Check that the AC symbol is present, symbol
above/below threshold located next to battery icon.
1 Change mode to HFO. 7 Ensure that the ventilator continues to operate
normally.
2 Set the ΔP to 80 mbar.
8 Ensure a battery percentage is displayed.
3 Open the alarm panel.
9 Change mode to CMV.
4 Reduce the upper Vte alarm threshold to
below the measured value.
5 Wait for approximately 20 seconds and the 23.2 Performance testing.
high expired volume alarm will now trigger, The performance test is divided into two steps,
(Message “Tidal volume above high conventional and oscillatory.
threshold”).
23.2.1 Conventional
6 Return the high alarm threshold to 30 ml.
1 Remove the flow sensor form the ET manifold
7 Reset any alarm messages. and occlude the ET manifold.
8 Increase the lower Vte alarm threshold to 2 Disconnect the flow sensor and press
above the measured value. “Continue without flow sensor”.
9 Wait for approximately 20 seconds and the low 3 Set the following:
expired volume alarm will now trigger, RR 30 BPM
(Message “Tidal volume below low threshold”). Ti 1 second
10 Return the low alarm threshold to 0 ml. PEEP 0 mbar
PIP 15 mbar
11 Reset any alarm messages.
4 Confirm that the measured PIP is 15 mbar ± 1
23.1.6 Volume alarm - Minute volume above/ mbar.
below threshold
5 Confirm that the measured PEEP is 0 mbar± 1
1 Reduce the upper Vmin alarm threshold to mbar.
below the measured value.
23.2.2 Oscillatory.
2 Wait for approximately 20 seconds and the
high minute volume alarm will now trigger, 1 Change mode to HFO.
(Message “Minute volume above high 2 Set the following:
threshold”). Frequency 5 Hz
3 Return the high alarm threshold to 18 l. I:E ratio 1:1
MAP 0 mbar
4 Increase the lower Vmin alarm threshold to ΔP 20 mbar
above the measured value.
3 Confirm that the measured ΔP is 20 mbar ± 1
5 Wait for approximately 20 seconds and the low mbar.
minute volume alarm will now trigger,
(Message “Minute volume below low 4 Confirm that the measured MAP is 0 mbar + 1
threshold”). mbar.

6 Return the low alarm threshold to 0 l. 5 Set the ΔP to 150 mbar


6 Confirm that the measured ΔP is 150 mbar ± 1
23.1.7 Power supply failure alarm - Main power
mbar.
fail and battery check
7 Confirm that the measured MAP is 0 mbar + 5
1 Disconnect the mains power by removing the
mbar.
plug from the supply socket.
8 Set the ΔP to 180 mbar
2 The power supply failure alarm will now trigger,
(Message “Main power fail”). 9 Confirm that the measured ΔP is >155 mbar.
3 Check that the AC symbol is no longer present, 10 Confirm that the measured MAP is 0 mbar + 12
symbol located next to battery icon. mbar.
4 Reconnect the mains power by inserting the 11 Set the ventilator to standby
plug into the supply socket.
12 Remove the test circuit.
5 The alarm message will cancel.

167
Functional testing

Functional testing is now complete.

Warning: If any of the above test fail do not


use the ventilator but withdraw it from service
and refer it to qualified service personnel for
repair/re-calibration.

168
Technical data

24. EMC compliance


The SLE6000 electro magnetic compatibility was
tested to and meets the requirements of the
following relevant standards:

EN60601-1-2
EN61000-3-2
EN61000-3-3

Guidance and manufacturer's declaration - electromagnetic emissions

The SLE6000 is intended for use in the electromagnetic environment specified below. The customer or the
user of the SLE6000 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment- guidance

RF emissions Group 1 The SLE6000 uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

RF emissions Class A The SLE6000 is suitable for use in all establishments other
CISPR 11 than domestic, and may be used in domestic establishments
and those directly connected to the public low-voltage power
Harmonic emissions Class A supply network that supplies buildings used for domestic
IEC 61000-3-2 purposes, provided the following warning is heeded:

Voltage fluctuations/ Complies Warning. This equipment/system is intended for use by


healthcare professionals only. This equipment/ system may
flicker emissions
cause radio interference or may disrupt the operation of
IEC 61000-3-3
nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the SLE6000 or
shielding the location.

169
Technical data

24.1 Electromagnetic immunity

Guidance and manufacturer's declaration - electromagnetic immunity

The SLE6000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
SLE6000 should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge Floors should be wood, concrete or ceramic


±6 kV Contact ±6 kV Contact
(ESD) tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
±8 kV Air ±8 kV Air
IEC 61000-4-2

Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines supply lines typical commercial or hospital
environment.
IEC 61000-4-4 ±1 kV for input/output Test not applicable
lines

Surge Mains power quality should be that of a


typical commercial or hospital environment.
±1 kV line(s) to line(s) ±1 kV line(s) to line(s)
IEC 61000-4-5 If the user of the SLE6000 requires
continued operation during power mains
interruptions, it is recommended that the
±2 kV line(s) to earth ±2 kV line(s) to earth
SLE6000 be powered from an
uninterruptible power supply or a battery.

Voltage dips, short <5 % UT <5 % UT Mains power quality should be that of a
interruptions and (>95% dip in UT) (>95% dip in UT) typical commercial or hospital environment.
voltage variations on for 0.5 cycle for 0.5 cycle
the power supply input
lines 40 % UT 40 % UT
(60% dip in UT) (60% dip in UT)
for 5 cycles for 5 cycles
IEC 61000-4-11
70 % UT 70 % UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles

<5 % UT <5 % UT
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s

Power frequency (50/ 3 A/m 3 A/m Power frequency magnetic fields should be
60 Hz) magnetic field at levels characteristic of a typical location
in a typical commercial or hospital
environment.
IEC 61000-4-8

NOTE UT is the a.c. mains voltage prior to application of the test level.

170
Technical data

Guidance and manufacturer's declaration - electromagnetic immunity

The SLE6000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
SLE6000 should assure that it is used in such an electromagnetic environment.

Immunity test IEC 60601 TEST Compliance Electromagnetic environment - guidance


LEVEL level

Portable and mobile RF communications equipment should be


used no closer to any part of the SLE6000, including cables,
than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.

Recommended separation distance


Conducted RF 10V 10V
IEC 61000-4-6 150kHz to 80MHz d = 1.2 p
in ISM bands

Radiated RF 10V/m 10V/m d = 1.2 p 80 MHz to 800 MHz


IEC 61000-4-3 80MHz to 2.5 GHz

d = 2.3 p 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter


in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in metres (m)b.
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site surveyc, should be less than the
compliance level in each frequency range.d
Interference may occur in the vicinity of equipment marked
with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
bThe
compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz
to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been
incorporated into the formulae used in calculating the recommended separation distance for transmitters in these
frequency ranges.
cField
strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the SLE6000 is used exceeds the applicable RF
compliance level above, the SLE6000 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the SLE6000.
dOver
the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m

171
Technical data

24.2 Recommended separation


distances.
Recommended separation distances between
portable and mobile RF communications equipment
and the SLE6000.

Recommended separation distances between


portable and mobile RF communications equipment and the SLE6000

The SLE6000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the SLE6000 can help prevent electromagnetic interference by maintaining a minimum
between portable and mobile RF communications equipment (transmitters) and the SLE6000 as recommended
according to the maximum output power of the communications equipment.

Rated maximum Separation distance according to frequency of transmitter


output power of m
transmitter
w 150 kHz to 80 MHz in ISM 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz
bands
d = 1.2 p d = 1.2 p d = 2.3 p

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.79 3.79 7.27

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,587 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

NOTE 3 An additional factor of 1013 has been incorporated into the formulae used in calculating the recommended
separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
objects and people.

172
Technical data

25. Pneumatic unit diagram Below is a schematic representation of the


pneumatic unit of the ventilator.

173
Technical data

25.1 Patient circuit pneumatic diagrams

174
Technical data

26. Software version identification


Below is a chart that allows the user to
identify the software version installed on
the ventilator.

System version number V1.0.17 V1.0.21 V1.0.25

Subsystem version Nº

Display board software 0.8.5 0.8.6 0.9.0

UI BIOS 3.22#3 3.22#3 3.22#3

MMS software 0.1.16 0.1.16 0.1.16

MMS hardware 2 2 2

Controller software 26 28 28

Controller Check sum 104 8 8

Controller hardware 3 3 3

Monitor software ISO 112 112 112

Monitor software non


38 39 41
ISO

Monitor hardware 3 3 3

ESMO software MO 0.9.0 0.9.0 0.9.0

ESMO software ES 0.3.0 0.3.0 0.3.0

ESMO hardware 2 3 3 or 4

PSU software 1.0.3 1.0.3 1.0.3

PSU hardware 4.1 4.1 4.1

User preferences 0.1.7 0.1.7 0.1.7

Caution. If the user finds a mis-match


of subsystem versions please do not
use the ventilator and refer it to a
qualified service technician.

175
Technical data

This page is intentionally left blank.

176
Installation instructions

Installation instructions
“Unpacking.” on page 178

“Medicart assembly” on page 179

“Ventilator unpacking” on page 180

“Ventilator assembly to Medicart” on page 181

“Mains cable attachment” on page 181

“Pre-use functional test.” on page 182

“Ventilator configuration” on page 182

177
Installation instructions

27. Installation instructions 27.1 Unpacking.


The following installation instructions allow the user 1. Place the shipping carton on a flat surface with
to assemble the ventilator and functionally test the access to all sides.
ventilator.

Warnings:
The ventilator should be commissioned only
by qualified service personnel.

Warnings:
A complete ventilator-trolley shipping carton
weighs approximately 60kg.and requires 2
person lifting.
The Ventilator carton weighs approximately
25 kg and removal from the shipping carton
requires 2 person lifting.
The ventilator weighs 22kg ±0.5kg. Failure to
secure the ventilator to the trolley can cause
the ventilator to fall off when in transit.
2. Open the top of the shipping carton and remove
Failure to secure the mains inlet cable to the the packing strips (A, B & C), this is to allow access
ventilator can cause the mains to be to the lifting handle for the ventilator carton.
disconnected whilst in use.
Failure to secure either the mains cable or the
ventilator, places the machine in an unsafe A



state, and the ventilator should not be used B
until these two items are rectified.


C
The following is the order for installation.
A. Unpacking
B. Trolley assembly.
C. Ventilator mounting.
D. Ventilator setup.

Note: The ventilator is supplied with a


commissioning procedure in the accessories
box.

27.0.1 Tools required for trolley assembly


5mm A/F Allen key Qty. 1
3mm A/F Allen key Qty. 1
Pozi drive screwdriver Qty. 1 Note: The packing strip (C) may be replaced
by a humidifier heater base.

Note: Accessory bags may be inserted into


the voids.

178
Installation instructions

3. Remove the ventilator carton by using the lifting 27.2.2 Assembly


handles. 1. Attach support column to wheel base using 6
button head screws and spring washers. Ensure the
D basket support (A) faces the towards the locking
castors (B) of the base.



E B


A

Note: This step requires two person lifting


from points D and E.

4. Remove the Medicart carton from the base of the


box.
Note: This step requires two person
F assembly.

2. Rotate the base and column and lock the front


wheels. Attach top plate (C) to the centre column
using 6xM6 countersunk screws (D).

D
G

C

Note: This step requires two person lifting


from points F and G.

5. The next stage is to assemble the Medicart.


27.2 Medicart assembly
27.2.1 Medicart kit contents
Top plate assembly .................. Qty. 1
Support column......................... Qty. 1
Base plate with castors ............. Qty. 1
Hose hook................................. Qty. 1
Humidifier mount....................... Qty. 1
Screws M6 button head ............ Qty. 6
Washers .................................... Qty. 6
Screws M6 Countersunk head.. Qty. 10

179
Installation instructions

3. Attach hook (E) to the column with 2xM6 3. Pull the plastic clip (A) out of the carton.Reapeat
countersunk screws. Slide the basket (F) into the until all four clips have been removed.
lower accessory mount, an optional set screw is
supplied for locking.


A


E 4. Lift the outer sleeve (C) from the base tray (D).

F


C


27.3 Ventilator unpacking

 
1. Place the ventilator carton on a flat stable  F
surface. E

A
D

Caution. The upper foam insert (E) and the


cardboard packing (F & G) may remain stuck
in the carton lid. This will cause any

accessories to fall out.


A A
5. Remove the accessories (H) packed in the two

pockets of the large insert.


A
H

2. Remove the four plastic clips (A) from the base H


tray. Squeeze the inner strip (B).

B

180
Installation instructions

6. Remove the upper foam and the two cardboard 27.5 Ventilator assembly to Medicart
inserts. Lift the ventilator out of the base foam pad
Place the ventilator on the Medicart.
using the rear lift point (J) and the front lift point (K).

K J



M

7. Place the ventilator of a stable flat surface and


remove the protective film. Remove the two red
protective caps (L).

Ensure that all the feet protrude through base tray


holes.Secure the ventilator by using the captive

screw (M) located on the underside of the base


plate.
L
27.6 Mains cable attachment
The ventilator is now ready to be mounted to the
Medicart. If the ventilator is not to be mounted on a The mains cable need to secured via the attached
Medicart then advance to section 27.6 “Mains cable clamp..
attachment” .

Note: Retain the packaging for future use.

27.4 Ventilator lifting points


The following are the lifting points for the ventilator.

N


O
Note: The mains lead is found in the
The front scoop and the rear handle. accessories pack supplied with the ventilator

Remove the cable clamp (N) by removing the two


screws (O).

181
Installation instructions

Insert the mains cable (P) into the inlet socket.

 N



O

Secure the cable by refitting the cable clamp (N)


using the two screws (O).

27.7 Pre-use functional test.


Carry out the “Ventilator basic setup” on page 22
and the “Functional testing (Invasive dual limb)” on
page 25.
27.8 Ventilator configuration
The ventilator is shipped with factory defaults as
listed in the technical specification. The user can
configure the ventilator by setting the user defined
features from the user preference application. See
“User preferences” on page 184.

182
User preferences

User preferences
“Accessing user preferences” on page 184
“Parameters tab” on page 184
“Ventilation tab” on page 185
“Alarms tab” on page 185
“Interface tab” on page 185
“Regional tab” on page 186
“Save / Quit tab” on page 186

183
User preferences

28. User preferences 28.1.1.1 Parameters


From this panel the following can be set.
This section describes all the features of the user
preference interface..
Note: User preferences can only be selected
from “Standby mode”.

28.1 Accessing user preferences


To access user preferences select “Utilities” or
“Calibration/Utilities” > “System” > “User
preferences”.
The user preferences number pad will be displayed.

Default ventilation mode.


RR (BPM) Range 1 to 150 BPM1
Default 30 BPM

Ti (seconds) Range 0.1 to 3 seconds2


Default 0.4 seconds

PIP (mbar) Range 0 to 65 mbar3


Default 15 mbar

PEEP (mbar) Range 0 to 35 mbar4


Default 4 mbar
O2% Range 21 to 100 %
Enter the default code of 0420 and press the Default 21%
confirm button.The user will now be presented with VTe Target (ml) Range 2 to 300 ml
the user preferences “Parameters” tab as the Default 3 ml
default.
I:E ratio 1:1, 1:2 & 1:3
28.1.1 Parameters tab Default 1:1
Form this tab the user can select the following: Trigger
sensitivity (l/min) 0.2 to 20 l/min
Parameters - Setting user defaults for power up. Default 0.6 l/min
Ventilation - Setting of ventilation pre-sets Apnoea backup
Alarms - Setting of alarm defaults. RR (BPM) 1 to 150 BPM
Default 40 mbar
Interface - Setting of interface defaults.
Regional - Setting on Language and units. MAP (mbar) 2 to 45 mbar
Default 5 mbar
Save/Quit - Save settings and factory reset.
Frequency (Hz) 3 to 20 Hz
Default 10 Hz

Note1: This parameter is limited by the set Ti.


Note2: This parameter is limited by the set RR.
Note3: This parameter is limited by the set
PEEP.
Note4: This parameter is limited by the set
PIP.

184
User preferences

28.1.2 Ventilation tab 28.1.3 Alarms tab


The ventilation tab sets the preference for features The alarm tab sets the preference for default limits
available in a ventilatory mode. for the displayed alarms available in a ventilatory
mode.

Manual breath maximum hold - Set Ti, 5 seconds


and 10 seconds. (Default set Ti)
High RR (BPM) - Range 0 to 150 BPM (Default 100
Manual sigh maximum hold - Set Ti, 5 seconds and BPM)
10 seconds. (Default set Ti)
High minute volume Conventional (ml) - Default
O2 Boost5 - ON or OFF (Default OFF) 18000 ml

O2 Suction5 - ON or OFF (Default OFF) Low minute volume Conventional (ml) - Default 0 ml

Pre-Set O2 for O2 Boost or O2 Suction - 100% or High minute volume HFO (ml) - Default 18000 ml
adjustable from 1 to 10% (Default 5%)
Low minute volume HFO (ml) - Default 0 ml
Apnoea time (sec) - Range 5 to 60 sec (Default
Note5: Only one function can be enabled. If 15sec)
the user turns on one function then tries to
turn on the other the first active function is 28.1.4 Interface tab
automatically turned OFF. The interface tab sets the user interface preferences
for features available in a ventilatory mode.

Monitored values panel Single column or Double


column (Default Single column )
Graph background - OFF or ON (Default OFF)
Waveforms - Lines or filled in (Default lines)

185
User preferences

28.1.5 Regional tab 28.1.6 Save / Quit tab


The interface tab sets the user interface preferences The Save / Quit tab allows the user to save or
for features available in a ventilatory mode. discard change to the user preferences.

The user is presented with three options.


Language6 - English (Default English) Save
Date Format - dd/mm/yyyy or mm/dd/yyyy Factory reset values
(Default dd/mm/yyyy) Exit
Pressure - mbar or cmH2O (Default mbar) Pressing Save will record the changes to system
memory. Press OK to return to the main menu.
Note6: English only in this release of
software. Pressing Factory reset values will reset the
ventilator to factory defaults but not record the
changes to system memory. The user should press
either the OK or SAVE button to record the changes
to system memory.

Pressing EXIT will end the user preference


session. The user will have to press and hold the
power button for 15 seconds to cycle the power.
Caution. Pressing the exit button without
saving will discard all changes made in this
session. The user will have no option but to
cycle power and repeat the process.

186
Event and patient log software

Event and patient Log software

187
Event and patient log software

29. SLE 6000 Event and patient log 29.3 Downloading the Patient log or
Event log
software
The process for downloading the log files is the
Caution: SLE 6000 Event and patient log same for Patient or Event log.
software is intended for research purposes
only. SLE 6000 Event and patient log software The Patient log process is shown below.
must not be used for clinical purposes Turn on the ventilator and allow it to enter Standby
including diagnosis or patient monitoring. mode.

29.1 Minimum system requirements Insert a USB memory


Operating system ... Windows XP stick into the data port
at the rear of the
CPU........................ Pentium or compatible,
ventilator.
300MHz
Memory .................. 128 MB
Hard drive............... 2 GB
Media ..................... CD-ROM drive or USB port
Display ................... Super VGA (800 × 600)
Input device(s)........ Keyboard, mouse Activate the Utilities tabs (1) and select the Data tab
(2).
.Net Framework...... version 3.5
2
29.1.1 Memory stick requirements
Type ....................... USB2

Size ........................ Minimum 1Gb
29.2 Installation of software
Insert the SLE USB memory stick supplied with the

ventilator into the host computer. 1
When the AutoPlay window appears select "Open
folder to view files.

Select the Patient Log button

Patient Log

From the Windows Explorer, copy the folder


"SLE6000 log viewers" to the C: drive of the host
computer.

When the transfer is complete the viewers are ready


to use.

188
Event and patient log software

On selection of the Patient log button the “Start The event log generates 2 files:
Export” button becomes active. Press the button to 1. 16_03_31_192345_SystemLog.evt
start the export to the USB memory stick.
2. 16_03_31_192225_DebugLog.evt

Patient Log Note: The ventilator does not overwrite any


existing files but creates new files with a
different serial code.
The ventilator will check the USB memory
Start export stick for enough free space for the new export
files. If not enough free space is available the
ventilator will display the following message
“The USB stick does not have enough free
space. Minimum XMB free space needed”.

The ventilator will display a progress bar during the Note: If the user also exports the screen
export process. Also displayed is a cancel button captures these will be located within the same
that allows the user to terminate the export process. folder.
File name:
16_04_01_193759_ScreenCapture_01.bmp

29.4.1 File types


The ventilator creates three file types, .dat .evt and
.txt. The .dat and .evt files can only be read by the
Patient Log supplied viewer software. the .txt file can be read by
most desk top publishing or spreadsheet programs.
29.4.1.1 RealtimeLog
File type: 16_03_31_192222_RealtimeLog.dat
Start export The RealtimeLog captures the real time waveform
data for pressure, flow, volume and CO2 (CO2 not
implemented in this release of software).
Cancel
29.4.1.2 AlarmsLog
File type: 16_03_31_192225_AlarmsLog.txt
When complete the ventilator will indicate that the The AlarmsLog captures all alarm conditions.
data export was OK.
Remove the USB memory stick from the ventilator. 29.4.1.3 TrendsDataLog
File type:16_03_31_192335_TrendsDataLog.dat
29.4 Export file formats The TrendsDataLog currently cannot be viewed in
The SLE6000 creates a folder with a identification this version of software.
number that is unique that ventilator.
29.4.1.4 SystemLog
Example: Ventilator ID 1001453795 File type:16_03_31_192345_SystemLog.evt
Within the folder the user will find a number of files. The SystemLog captures all the user interaction
Each file is prefixed with the date followed by serial with the ventilator.
code and then file type.
29.4.1.5 DebugLog
Example: 16_03_31_192222_RealtimeLog.dat File type:16_03_31_192225_DebugLog.evt
The patient log generates 3 files: The DebugLog captures all the software messages.
1. 16_03_31_192222_Realtimelog.dat This feature is for service personnel only.
2. 16_03_31_192225_AlarmsLog.txt 29.4.1.6 Log records
3. 16_03_31_192335_TrendsDataLog.dat 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.

189
Event and patient log software

29.5 Reading patient Log files (.dat) The viewer will now open the Realtimelog file and
present the user with the real time log options.
As previously described the ventilator is supplied
with two applications located within the SLE6000
log viewers folder that has been copied to the host
computer.
If the user opens the folder they will see two .exe
files.
For viewing patient log data the user must select
SLE6000 Patient Log.exe.
To run the application double click the SLE6000
Patient Log.exe executable file, or select the file,
right click and select open, this will run the
application. To view a specific set of waveforms select and
double click the text in the left hand column.
The user will now see the SLE6000 Patient Log
viewer window appear.

The viewer will now display the pressure waveform


log table.

To view a RealtimeLog file click on the "Open log


file" button.

This will open the file navigator window. Navigate to


the USB memory stick or the location to where the
file have been copied.

From the log table scroll to the time stamp required.

Double click the start time in the left hand column.


This will display the pressure waveform and data for
Select the required Realtimelog.dat file and click the selected time period.
"Open".

190
Event and patient log software

The user can export the information in the left hand 29.7 Reading Event Log files (.evt)
window to a .CSV file.
As previously described the ventilator is supplied
with two applications located within the SLE6000
log viewers folder that has been copied to the host
computer.
The CSV file is stored in the same folder location as If the user opens the folder they will see two .exe
the source Log file. files.
The application will create a CSV file name that For viewing event log data the user must select
contains the date and time stamp of the record SLE6000 Event Log.exe.
selected. To run the application double click the SLE6000
Event Log.exe executable file, or select the file, right
click and select open. this will run the application.

29.7.1 Event log


Example: The user will now see the SLE6000 Event Log
SLE6000Data Flow 31_03_2016 19_00_04.csv viewer window appear.
The process is the same for Flow and Volume.
Note: CO2 is non functional in this release of
software.

29.6 Reading Patient Log files (.txt)


The patient log export produces one file that can be
read by any program that can open simple text files
(.txt)
Opening the file will give the user the last 1000
alarm messages.
The file contains the time, date, alarm message,
duration, priority, alarm acknowledgement, value,
limit and alarm ID.

To view a system log file click on the "Open log file"


button.

This will open the file navigator window. Navigate to


Example log: the USB memory stick or the location to where the
file have been copied.
Time/Date Message Duration
03:58,23-03-16,High Patient Leak.,000:03:31,
Priority Acknowledgement Value Limit ID
HIGH, UNACKNOWLEDGED, ,5 ,53
When the alarm log reaches 1000 messages the
newest message will push the oldest message out
of the log. Discarded messages can not be
retrieved.

191
Event and patient log software

Select the required Systemlog.evt file and click


"Open".

The viewer will now display the system event log


table.

The log will display a chronological list of all user


actions recorded by the ventilator.
The user can only view the system log. Currently
there is no export facility.

29.7.2 Debug log


The debug log is a service function and requires the
user to tick "Open as Engineering (debug) Event
Log box.

For more information on the debug log please refer


to the SLE6000 service manual.

192
Training

30. Training (User) 31. Training (service)


SLE provide user training courses for the SLE6000 SLE provide service training courses for the
infant ventilator. SLE6000 infant ventilator.

End-User Training The courses cover the servicing and maintenance


SLE, or their Distributor, offers clinical support to all of hardware and software of the SLE6000 infant
users of SLE ventilators. This is always coordinated ventilator.
through the local Sales Specialist or Distributor to
ensure effective use of your time. Over the course Please contact SLE Ltd.
of the ventilator installation, a specialist will ensure
that users receive in-depth training on SLE Please ask for “Service training”
products.
Telephone: +44 (0)20 8681 1414
On-Going Training Fax: +44 (0)20 8649 8570
Once the ventilator has been installed and
commissioned, SLE or your local Distributor’s E-mail: service@sle.co.uk
clinical support staff, will spend time in the NICU,
with the medical and nursing staff, to answer any
questions that may arise and offer further support.

Specialist in vivo Workshops


SLE supports clinician-led ventilation seminars; the
seminars are aimed at consultant level
Neonatologists and Paediatric Intensivists.

In some countries SLE will sponsor a clinical expert


to present a seminar using a prepared animal lung
to demonstrate lung recruitment. This is usually
aimed at Registrars, House Officers and senior
nursing staff.

Additionally, SLE runs a series of in vivo ventilation


workshops around the world each year. These
courses are intended for clinicians and focuses on
lung protective strategies. Using an in vivo model,
these seminars are hands-on and include both
conventional and high-frequency oscillation
ventilation.

Please contact SLE Ltd.

Please ask for “End user training”

Telephone: +44 (0)20 8681 1414


Fax: +44 (0)20 8649 8570

E-mail: sales@sle.co.uk

193
Training

This page is intentionally left blank.

194
Accessories

Accessories

195
Accessories

32. Accessories
Note: For consumables please refer to the Warning. Use of cables other than those
SLE6000 consumables catalogue. This is listed below may result in increased
available on request from SLE or the electromagnetic emissions or decreased
distributor. electromagnetic immunity

Item Part No

Flow Sensor connecting cable with anti microbial coating. (1.5 N6656
m)

Mains cable (1. 5m) UK 3 pin plug & 90º IEC connector M0255/095

Mains cable (1.5 m) Shuko (European) plug & 90º IEC M0255/096
connector

Mains cable (1.5 m) Nema North American) plug & 90º IEC M0255/097
connector

RS232 cable (2 m) L6000/232/001

VGA video cable (Male to Male) 2m L6000/VGA/001

Nurse call cable (3 m fully wired) L6000/NCW/001

Nurse call cable (3 m normally open) L6000/NCO/001

Nurse call cable (3 m normally closed) L6000/NCC/001

DC input cable (2 m) L6000/0DC/001

Spare exhalation Block. N6622

Silencer (Autoclavable) N2186/01

Oxygen water trap assembly L6000/XWT

O2 hose, 3 metres length - 90º NIST nut to BS probe. N2035/RAC/001


Tube colour white.

196
Accessories

Item Part No

Air hose, 3 metres length - 90º NIST nut to BS probe. Tube N2199/RAC/001
colour black.

O2 hose, metres length - 90º DISS to DISS. Tube colour black N2035/RDS/001

Air hose, 3 metres length - 90º DISS to DISS. Tube colour black N2199/RDS/001

MR850 Humidifier Heater Base. (230V) For UK Only. N3850/00

MR850 Humidifier Heater Base. (230V) N3850/01

Heater Adapter for use with Single Use patient circuits & N5600
chambers and MR850 Humidifier Heater Base.

Dual Heater Adapter for use with Single Use patient circuits & N5601
chambers and MR850 Humidifier Heater Base.

MR858 Heater Adapter for use with Re-usable patient circuits & N3858
chambers and MR850 Humidifier Heater Base.

MR860 Dual Temperature Probe (for 850 F&P humidifier). N3860

197
Accessories

Item Part No

Test Lung. N6647

Medicart with two locking castors, basket, hose hook and medi N6690
rails.

Patient Circuit Arm. N6627/212

User Manual for SLE6000. (English) UM154/UK

User Manual for SLE6000. (French)

User Manual for SLE6000. (Spanish)

User Manual for SLE6000. (German)

User Manual for SLE6000. (Portuguese)

Service Manual for SLE6000 SM39

198
Glossary

33. Glossary HFNC High flow nasal cannulae

Hz Hertz (Cycles per second)


ASCII (American Standard Code for
Information Interchange) is the most I:E Inspiratory: Expiratory Ratio
common format for text files in
computers. Not suitable for non- Insp Time Inspiratory Time
English letters but suitable for
ISM Industrial, scientific, and medical
numerics.
kg Kilogram
O2 Oxygen
kHz Kilohertz
°C Degrees Celsius
LED Light Emitting Diode
°F Degrees Fahrenheit
LF Low Frequency
≈ Approximately equal to
l/min Litre per Minute
bar Unit of Barometric Pressure
mbar Millibar
BPM Breaths Per Minute
MHz Megahertz
BTPS Body temperature and pressure
staturated MMS Messaging Management System
C20/C Ratio of the compliance during the ml Milliliters
last 20% of the respiratory cycle
compared to whole cycle ms Millisecond

cm Centimetre Mean P Mean Pressure

cmH2O Centimetres of water NEEP Negative End Expiratory Pressure

CMV Continuous Mandatory Ventilation NIPPV nasal intermittent Positive Pressure


Ventilation
Compl. Compliance
NCPAP Nasal Continuous Positive Airway
CPAP Continuous Positive Airway Pressure
Pressure
NHFO Nasal High Frequency Oscillation
CPU Central processing unit
MAP Mean airway pressure
DCO2 Gas transport coefficient, based on
tidal volume and frequency. MO Monitor output

DHW Dual heated wire O 2% Percentage Oxygen

dP Delta Pressure PEEP Positive End Expiratory Pressure

DPI Dots per inch PIP Peak Inspiratory Pressure

EMC Electromagnetic Compatibility POST Power on self test

ES External Sensor PPM Planned preventative maintenance

ESMO External Sensor & Monitor psi Pounds per Square Inch

ET Endotracheal PSU Power Supply Unit

GHz Gigahertz PTV Patient Triggered Ventilation

GMDN Global Medical Device RF Radio Frequency


Nomeclature.
RR Respiratory Rate
HFO High Frequency Oscillation
Resist. Resistance
HFOV High frequency oscillatory
ventilation

199
Glossary

RS232C RS232 is a long established


standard for low speed serial data
communication, “C” being the
current version.

SaO2 Saturated oxygen

SIMV Synchronised Intermittent


Mandatory Ventilation

STPD Standard temperature and pressure


dry.

Ti Inspiratory time

VTV Volume Targeted Ventilation

tcPCO2 Transcutaneous Carbon Dioxide

tcPO2 Transcutaneous Oxygen

UI User interface

USB Universal Serial Bus

VLBW Very low birth weight

VGA Video Graphics Array

Vol. Cont. Volume Control

Vexp(ml) Expired Volume Control in millilitres

Vinsp(ml). Inspired Volume in millililtres

Vmin (l) Minute Volume in litres

Vt Tidal volume

Vte Tidal Volume expiratory

200
Marking and symbols

34. SLE6000 markings and


symbols
USB port
34.1 Description of ventilator markings
.

General Warning Symbol Symbol for Equipotentiality

Caution Symbol Direct Current icon

Warning, Electricity Device weight

Refer to Instruction Manual/Booklet On/Off

Type BF Applied Part Symbol CE mark and notified body


number

Nurse Symbol Serial number

Ethernet port Manufacturer

VGA port Date of manufacture

201
Marking and symbols

WEEE Symbol Lower alarm limit

34.2 Description of interface markings.


Screen capture

Warning Symbol

Backspace

Mains power icon

Close

Direct Current icon

Scroll up

Battery icon 100%

Scroll down

Battery icon 0%

Zoom in (Zoom)

Fuse Symbol

Zoom out (Zoom)

Audio paused

Scroll left (Cursor)

Upper alarm limit

202
Marking and symbols

Scroll right (Cursor)

Scroll left (Scroll)

Scroll right (Scroll)

HFO in expiration phase only.

HFO in inspiration and


expiration phase.

Locked screen

Play

Pause

Confirm

203
Marking and symbols

This page is intentionally left blank

204
SLE reserves the right to make changes without
prior notice in equipment, publications and prices as
may be deemed necessary or desirable.

Revision History

Rev. Date Change ref.

1 24/07/16 Initial issue.

2 13/10/16 CR 733, 734, 748, 749, 776,


782, 787, 801, 803, 810,
825 & 830.

3 20/10/16 CR 834

4 17/01/17 CR 958

5 31/03/17 CR891, 968, 997, 1001,


1012 & 1022

6 25/04/17 CR1043

205
+44 (0)20 8681 1414 SLE Limited

Twin Bridges Business Park


+44 (0)20 8649 8570
232 Selsdon Road

sales@sle.co.uk South Croydon

Surrey
www.sle.co.uk
CR2 6PL

UK

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