SLE 2000 Infant User manual

SLE 2000

Ventilator

User manual

Infant Ventilator

0120

Issue

9

Contact Information:

SLE Limited
Twin Bridges Business Park
232 Selsdon Road
South Croydon
Surrey CR2 6PL

Telephone: [phone]

Fax: [phone]

E-mail: [email protected] (E-mail’s should be addressed to the Service Manager)

Web site: www.sle.co.uk

All rights reserved. No part of this publication may be reproduced, stored in any retrieval system, or
transmitted in any form or by any means, electronic, mechanical, photocopy, recording or otherwise,
without prior permission of SLE. © Copyright SLE 01/10/2004.

Manual : UM0017 Issue 9
SLE Part Nº: N2000/11

Page 2 of 66

Contents

1. Introduction .................................................................................................7

2. Principles of Operation SLE2000 Valveless System ................................ 8

3. User/Owner Responsibility ........................................................................9

4. Warnings ......................................................................................................10

4.1. Operational Warnings......................................................................... 10

4.2. Clinical Warnings................................................................................ 11

5. Glossary of Abbreviations Used in This Manual ...................................... 13

6. Symbols .......................................................................................................14

Operating Instructions

7. Ventilator Description .................................................................................16

7.1. Front Panel.........................................................................................16

7.2. Function of Front Panel Controls and Indicators ................................ 17

8. Functional Tests .......................................................................................... 19

8.1. Pressure Regulators and Gauges ...................................................... 19

8.2. Pre-setting alarm limits.......................................................................20

8.3. Power On Automatic Test...................................................................20

8.4. Pressure Display.................................................................................20

8.5. CMV Mode..........................................................................................21

8.6. PTV Mode...........................................................................................21

8.7. SIMV Mode......................................................................................... 22

8.8. Alarm Test ..........................................................................................23

8.8.1. Low CPAP....................................................................................23

8.8.2. High and Cycle Fail Alarm............................................................ 23

8.8.3. Leak and Block Alarms ................................................................ 24

8.8.4. Mains failure alarm.......................................................................24

8.8.5. O2 Blender Alarm.........................................................................25

8.9. Condition of O2 Cell............................................................................ 25

8.10. Completing Functional Testing .........................................................25

8.11. Basic Set Up..................................................................................... 26

8.12. To Use the SLE2000 in CPAP Mode................................................27

8.12.1. Manual breaths in CPAP mode..................................................27

8.13. To Use the SLE2000 in CMV Mode.................................................. 28

8.14. Patient Triggered Modes .................................................................. 29

8.14.1. To use SLE 2000 in PTV and SIMV mode................................29

Technical Information

9. Ventilator Controls ......................................................................................32

9.1. Electronic module...............................................................................32

9.1.1. Power Switch (5 positions).........................................................32

9.1.2. System Fail LED .......................................................................... 32

9.1.3. CPAP Mode .................................................................................32

9.1.4. CMV Mode...................................................................................32

9.1.5. PTV Mode....................................................................................33

9.1.6. SIMV Mode. ................................................................................. 33

Page 3 of 66

9.1.7. BPM .............................................................................................35

9.1.8. Inspiration Time............................................................................35

9.1.9. I:E Ratio .......................................................................................35

9.1.10. Oxygen (FlO2)............................................................................35

9.1.11. Pressure Display........................................................................ 35

9.1.12. Three position switch. ................................................................ 36

9.1.13. Pressure Wave Switch............................................................... 36

9.1.14. Manual Breath............................................................................36

9.2. Pneumatic Module.............................................................................. 37

9.2.1. Proximal Airway ........................................................................... 37

9.2.2. Removable Exhalation Block N2190............................................37

9.2.3. Fresh Gas Port.............................................................................37

9.2.4. Regulator and Pressure Gauges..................................................38

9.2.5. O2 Blender (% FlO2) ....................................................................38

10. Alarms ........................................................................................................ 39

10.0.1. Microprocessor...........................................................................39

10.0.2. Mains Failure Audible Alarm......................................................39

10.0.3. Gas Supply Failure Alarm..........................................................39

10.0.4. Fresh Gas Fail Alarm (Block & Leak).........................................40

10.0.5. Adjustable Alarm........................................................................40

10.0.6. High Alarm ................................................................................. 40

10.0.7. Cycle Fail Alarm........................................................................40

10.0.8. Low CPAP Alarm ....................................................................... 41

10.0.9. O2 Blender Alarm.......................................................................41

10.0.10. Alarm Mute...............................................................................41

10.0.11. Alarm Volume...........................................................................41

10.0.12. Alarm Verification..................................................................... 41

11. Auxiliary Output ........................................................................................42

12. Rear Panel .................................................................................................. 43

13. Patient Circuit Connection .......................................................................44

14. Filter Systems ............................................................................................ 46

14.1. Bacterial filter, SLE Part Nº:N2029 (Autoclavable)...........................46

14.2. Bacterial filter, SLE Part Nº:N2587 (Single use)............................... 46

14.2.1. Precautions when using bacterial filter N2587........................... 46

15. Cleaning, Disinfection and Sterilization ..................................................47

15.1. Preparation of a new ventilator......................................................... 47

15.2. Cleaning and disinfection of an in-service ventilator......................... 47

15.2.1. Cleaning, Disinfection & Sterilization chart ................................ 48

15.3. Cleaning method...............................................................................48

15.4. Disinfection method..........................................................................49

15.5. Sterilization method..........................................................................49

16. User Operational Checks .........................................................................50

17. SLE2000 Trouble Shooting Chart ............................................................51

18. Service Programmes ................................................................................ 54

19. Pressure unit conversion constants .......................................................56

Page 4 of 66

20. Technical Specification ............................................................................57

20.1. Conventional Ventilation................................................................... 57

20.2. Displays............................................................................................57

20.3. Controls ............................................................................................ 58

20.4. Alarms...............................................................................................59

20.5. Air and Oxygen Supplies..................................................................59

20.5.1. Oxygen supply ...........................................................................59

20.5.2. Air supply ................................................................................... 59

20.6. Power , Dimensions etc.................................................................... 60

21. Consumables and Accessories for SLE 2000 ........................................ 61

22. Ordering Information ................................................................................63

23. Technical Bulletins ................................................................................... 64

Page 5 of 66

How to use the SLE2000

NOTE THE WARNINGS (PAGE 10) MUST BE READ AND UNDERSTOOD
BEFORE USING THE SLE2000 VENTILATOR. FAILURE TO DO SO COULD
LEAD TO INJURY OR DEATH

1 PERFORM THE FUNCTIONAL TESTS : PAGE 19

(THIS SHOULD TAKE NO MORE THAN 20 MINUTES)

2 SETUP THE SLE2000 IN THE CHOSEN MODE: PAGE 26

3 THE SLE2000 IS READY FOR USE

FOR MORE INFORMATION SEE TECHNICAL SECTION PAGE 32

FOR TROUBLE SHOOTING SEE TROUBLESHOOTING CHART PAGE 51

Page 6 of 66

1. Introduction

The SLE2000 is a constant flow, time cycle, and pressure limited neonatal ventilator
with patient triggering.

Main features are that it has no expiratory valve but uses a reverse flow of mixed gas
that is injected from the exhaust manifold into the expiratory limb of the patient circuit.
This flow of gas has the effect of compressing 5 LPM humidified gas into the patient
ET tube.

The advantage of this system is that there is no expiratory resistance due to valves or
diaphragms, therefore no inadvertent PEEP is generated.

Page 7 of 66

2. Principles of Operation SLE2000 Valveless System*

The patient circuit is supplied with a constant fixed flow of 5LPM fresh gas. This gas
comes from the internally mounted oxygen blender and its concentration is also
monitored by a fuel cell and displayed on the FlO2 digital display. This fresh gas

supply is then passed through a humidifier to the inspiratory port of the patient ET
connector. Built into the ventilator are circuits to detect either a gas flow failure or a
tubing blockage. The patient circuit requires a restrictor fitted into the inspiritory port.
Therefore, only SLE approved patient circuits must be used.

The Expiratory limb of the patient circuit is connected to the Exhalation port on the
ventilator. This consists of a removable block mounted on a manifold, accessed by
lowering the left hand side cover. The expiratory manifold has two nozzles. The front
one to generate CPAP/PEEP and is supplied via the CPAP regulator on the front
panel of the Pneumatic Module. The rear one to generate peak inspiratory
pressure(PIP).

To avoid the possibility of gas dilution these regulators are supplied with the same
oxygen concentration as the Fresh Gas supply . The front nozzle is used to generate
an opposing flow to the Fresh Gas in the exhalation block and thus create CPAP The
rear nozzle is used to generate the peak inspiratory pressure in the same way,
supplying constant pressures at all breathing rates.

The PIP regulator and gauge on the
front panel set the pressure that is
supplied to a solenoid valve which is
connected to the rear nozzle.
The Electronic Module controls the rate
and duration of the flow of Driving Gas
into the Exhalation block in opposition
to the Fresh Gas flow. This opposing
flow acts as a pneumatic piston and
creates a pressure wave at the ET
manifold. The lung inflation pressure
and hence the tidal volume are
controlled by the PIP regulator.

NOTE: The ventilator should be set to a square waveform for breathing rates
above 60 BPM

* The Valveless Ventilation Principle was designed and patented by Prof. J G Whitwam and Mr.
M. K. Chakrabarti of the R.P.G.M.S Hammersmith Hospital.
This patent is exclusively licensed to SLE

THE EQUIPMENT IS HOUSED IN TWO MODULES, PNEUMATIC AND
ELECTRONIC, THESE CAN BE UNCOUPLED FOR EASE OF SERVICE.

Page 8 of 66

3. User/Owner Responsibility

This SLE 2000 INFANT VENTILATOR and the authorised accessories for it are
designed to be used in accordance with supplied manuals and instructions. This
equipment must be periodically checked, recalibrated, maintained and components
repaired and replaced when necessary for the equipment to operate safely and
reliably.

Parts that have failed, in whole or in part, or exhibit excessive wear, or are
contaminated, or are otherwise at the end of their useful life, should not be used and
must be replaced immediately with parts supplied by SLE, or parts which are
otherwise approved by SLE. Equipment which is not functioning correctly or is
otherwise in need of repair or maintenance must not be used until all necessary
repairs and/or maintenance have been completed and a factory authorised service
representative has certified that the equipment is fit and ready for use. This
equipment, its accessories or component parts should not be modified. The use of
non-approved parts or accessories will invalidate the warranty.

The owner/user of this equipment shall have the sole responsibility and liability for any
damage or injury to persons or property (including the equipment itself) resulting from
operation not in accordance with the operating instructions, or from faulty
maintenance not in accordance with the authorised maintenance instructions, or from
repair by anyone other than the factory authorised service representative, or from
unauthorised modification of the equipment or accessories, or from the use of
components or accessories that have been either damaged or not authorised for use
with this equipment by the manufacturer.

Page 9 of 66

4. Warnings

4.1 Operational Warnings

The following warnings must be read and understood before using the SLE2000
ventilator. Failure to do so could lead to injury or death.

1 The whole of this manual should be read and understood before using the

SLE2000. Operators must be suitably trained and clinically authorised for using
the SLE2000 with patients. Particular care should be taken to check the
ventilator pressures prior to changing modes.

2 It is recommended that the back panel BPM range key switch is removed during

use.
3 Oxygen - Clinical use. Oxygen is a drug and should be prescribed as such.
4 Oxygen - Fire Hazard. Oxygen vigorously supports combustion and its use

requires special precaution to avoid fire hazards. Keep all sources of ignition

away when oxygen is in use. Do Not use oil or grease on oxygen fittings or

where oxygen is used.
5 Audible and Visual warning alarms indicate a potentially harmful condition to the

patient. However when ventilating a patient with a 3mm or smaller size

endotracheal tubes, in case of patient extubation or the ET tube

disconnecting from its ET connector, only the monitoring of flow (module

SLE 2100), or of SpO2, or Pt02/PtCO2 will dependably alert the medical

team to an alarm situation, not the monitoring of pressures.

6 When the ventilator is being used on a patient, a suitably trained person must be

in attendance at all times to take prompt action should an alarm or other

indication of a problem occur.
7 The ventilator functional tests must be carried out each time the SLE 2000 is

used on patients. If any of these tests do not function as described then there is

a problem and the ventilator must not be used until it is rectified.
8 The humidifier used in the patient circuit must be operated and maintained in

accordance with its manufacturer’s instructions. It is the owners responsibility to

ensure that the equipment is regularly maintained. (See service programme on

page 54)
9 Any water trap used in the patient circuit must be drained regularly before it is

full.
10 Failure to comply with the recommended service programs could lead to injury to

the patient, operator or damage to the ventilator. It is the owners responsibility

to ensure that the equipment is regularly maintained. (See service programme

page 54)

on
11 Functioning of this ventilator may be adversely affected by high frequency

surgical (Diathermy) , defibrillators, mobile phones, short-wave therapy or

equipment producing strong magnetic fields, operating the in vicinity.

Page 10 of 66

12 The Ventilator must be plugged into a suitably rated and grounded electrical

power source.
13 There is no special protection provided against ingress of water or liquids.
14 The equipment is not suit able for use with, or in the presence of flammable

anaesthetic mixtures.
15 Use only SLE approved patient circuits. On no account should antistatic or

electrically conductive tubing be used in the patient circuit.
16 No external volt age should be applied to the auxiliary socket. Any connections to

this socket must be approved by SLE and screened to comply with EMC

regulations. Ensure protection cap is fitted when socket is not in use.
17 The electronic module of the ventilator contains a primary battery for mains

failure alarm, if the ventilator is not to be used for 3 months or more, then the

battery should be removed.
18 Care should be taken when attaching other equipment as this may affect

stability.
19 When using nebulizers and other delivery systems e.g. NO with the ventilator in

High Alarm or gas leak condition, the patient can receive inaccurate mixtures.
20 If the SLE 2000 Infant Ventilator is adversely affected by equipment emitting

electromagnetic interference then that equipment should be switched off or

removed from the vicinity of the 2000. Conversely, if the 2000 is the source of

such interference to neighbouring equipment then it should be switched off or

taken to another location.

4.2 Clinical Warnings

Failure to take corrective action when alarms function could result in injury or death to
the patient.

There are risks inherent in the use of mechanical ventilation in the newborn and
during infancy and childhood. These may include:

1 Under- or over-ventilation (with consequent abnormalities in blood gases).
2 Incorrect humidification.
3 Intracranial haemorrhage, cerebral ischaemia.
4 Chronic lung disease (bronchopulmonary dysplasia in the newborn).
5 Damage to trachea and bronchi.
6 Over- or under-inflation of the lung.
7 Atalectasis.
8 Air leak syndrome (pneumothorax, pneumomediastinum, pneumopericardium.

pulmonary interstitial emphysema).

Page 11 of 66

9 Circulatory abnormalities (reduced systemic or pulmonary venous retum,

hypotension, tachycardia, bradycardia, reduced cardiac output, excessive

variability of blood pressure).
10 Mobilisation of secretions and airway blockage.
11 Exposing a baby to elevated concetrations of Oxygen may lead to Retrolental

Fibroplasia. (Retinopathy of prematurity)

The minimum patient monitoring requirements for Ventilation are:
1 ECG/heart rate.

2 Chest wall movement.
3 Blood pressure (continuous intravascular/regular, intermittent measurements).
4 Transcut aneous carbon dioxide/intravascular carbon dioxide/regular, intermittent

arterial/capillary samples.
5 Regular arterial and transcutaneous blood gas monitoring.
6 Regular chest X-rays.
7 Regular cranial ultrasound examinations.
8 Standard nursing care for Intensive Care patients.

Page 12 of 66

5. Glossary of Abbreviations Used in This Manual

bar
BPM
cm
cms
cmH2O

CMV

CPAP

°C
°F
EMC

ET

Unit of Pressure
Breaths Per Minute
Centimetre
Centimetres
Centimetres of Water

Controlled Mechanical
Ventilation

Continuous Positive Airway
Pressure

Degrees Celsius
Degrees Fahrenheit
Electromagnetic Compatibility

Endotracheal

LED
LF
LPM
MIT
ml

ms

O

2

PTV
PIP
PEEP

psi

Light Emitting Diode
Low Frequency
Litres per Minute
Maximum Inspiratory Time
Millilitres

Millisecond

Oxygen

Patient Triggered Ventilation
Peak Inspiratory Pressure
Positive End Expiratory

Pressure
Pounds per Square Inch

FIO

2

Hz

I:E

Insp.
Kg

Fractional Concentration of
Inspired
Oxygen

Hertz

Inspiratory : Expiratory Ratio

Inspiration Time
Kilogram

SaO

2

SIMV

tcPCO

tcPO

2

≈

Saturated oxygen

Synchronised Intermittent
Mandatory Ventilation

Transcutaneous Carbon

2

Dioxide
Transcutaneous Oxygen

Approximately equal to

Page 13 of 66

6. Symbols

The Following Symbols are used on the Equipment

Alternating Current

Attention, consult accompanying documents.

Conformance mark and notified body registration

0120

Type B (IEC601-1) protection against electric shock.

I On (power: connection to the mains)
O Off (power: disconnected from the mains)

Rotate: clockwise to increase, anticlockwise to decrease

Page 14 of 66

Page 15 of 66

7. Ventilator Description

The SLE 2000 consists of two linked modules, Electronic and Pneumatic.

Electronic
Module

Pneumatic
Module

7.1 Front Panel

2

28

27

26

25

3

1

4

5

7

6

9

8

10

11

12

13

14

15

16

17

18

Page 16 of 66

24

23

22

21

20

19

7.2 Function of Front Panel Controls and Indicators

Nº Item Description

1 POWER and

OPERATIONAL

MODE Switch
2 POWER LED Indicates power is ‘ON’.
3 SYSTEM FAIL LED When this LED lights and the alarm sounds, it

4 BPM digital display

with adjustment

knob
5 INSP. TIME digital

display with

adjustment knob
6 FRESH GAS

BLOCK audible

alarm.
7 I:E RATIO digital

display

Selects Power OFF, ALARM TEST/CPAP, CMV,
PTV, SIMV modes.

indicates failure of the main processor. If this
happens, the ventilator must be removed from
service.

Displays between 1-250 BPM.
Available in two ranges: 1-125 BPM& 126-250
BPM, selectable by rear security key switch

Inspiratory Time
Displays 0.1-3.0 seconds in 1-125 BPM range
or 0.01-0.3 seconds in 126-250 BPM range.

Indicates problems within the patient circuit line.

Displays from 9.9:1 to 1:9.9 calculated from BPM
and Insp. time

8 LEAK LED’s

audible alarm.
9 MAX MEAN MIN

switch with digital

PRESSURE display
10 FIO2 digital display Accurately displays the % O2 as set by the Air-

11 TRIGGER BACK-

UP LED

12 MANUAL BREATH

Pushbutton

13 Pressure Gauge -6

to +60 cmH2O.

14 PTV SENSITIVITY

control

Indicates problems within the patient circuit line.

Selects and displays Max., Mean or Min airway
pressures.

Oxygen Blender.
Indicates a machine-delivered breath due to patient

failure to trigger ventilate or during back-up time
window.

Causes delivery of a single breath in CPAP, CMV
and PTV modes to preset inspiration times and
pressures.

Proximal Airway Pressure. This pressure is
displayed more accurately by the independent
digital display.

Variable patient trigger level setting.
Sensitivity between 1(least sensitive to patient
effort) and 5 (most sensitive to patient effort).

Page 17 of 66

Nº Item Description

15 PRESSURE WAVE

switch
16 ALARM MUTE

Pushbutton and

LED
17 AIR OXYGEN

BLENDER control

18 O2 inlet O2 hose connector.
19 Medical air inlet Medical air hose connector.

20 Inspiratory

Pressure

Regulator
21 SYSTEM DRIVING

PRESSURE gauge

22 CPAP/PEEP

regulator

Permits change of leading edge of pressure wave
from square to taper in 1-125 BPM range only.

Mutes audible alarms for one minute.

Sets air/oxygen mix between 21 and 100% 02 ±
3% with digital indication from independent

monitoring circuits.

Adjusts driving pressure to set circuit inspiratory
pressure.
Range 0-60 cmH2O.

Approximate indication of the pressure above
PEEP which will be delivered to the patient in CMV,
PTV, SIMV or manual breath modes.

Sets CPAP level in the circuit, range is 0 to 15
cmH2O (nominal).

23 ALARM RESET

Pushbutton
24 Fresh Gas Port 5LPM blended gas supply to patient (ventilator

25 Proximal airway Proximal airway tube connector.
26 Exhalation block Connection for expiratory limb of patient circuit.
27 PIP, CYCLE FAIL

and HIGH alarm

LED’s with control
28 CPAP Alarm LED

and control

Resets audible and visual alarms.

powered up).
1LPM blended gas supply to patient (ventilator
OFF)

Sets visual and audible alarm level for inspiratory
pressure between 0 and 60 cmH2O.

Sets visual and audible alarm level for CPAP
pressure.

Page 18 of 66

8. Functional Tests

The following functional tests must be carried out to ensure that this equipment
is working correctly before connection to a patient.

• NOTE: IF ANY OF THESE TESTS DO NOT FUNCTION AS DESCRIBED,
THERE IS A PROBLEM AND THE UNIT SHOULD NOT BE USED UNTIL IT HAS
BEEN REPAIRED. PLEASE CONTACT AN SLE APPROVED ENGINEER, OR
SLE.

With Power switch set to OFF carry out the following steps.

 Connect AIR, OXYGEN Hoses to ventilator and plug into

gas supplies, at a gas pressure of about 4 bar.

 Connect mains cable to a suitably rated and grounded

electrical power source.

 Connect SLE approved patient circuit with test lung to the ventilator. For further

Air

O

information see page 44 or instructions supplied with patient circuit.

8.1 Pressure Regulators and Gauges

Check the CPAP/PEEP regulator, by turning the control from minimum to
maximum making sure the large gauge reads between 0 and greater than 15.
Check the INSPIRATORY regulator, by turning the control from minimum to
maximum and making sure that the system driving pressure gauge reads between
minimum and maximum, this gauge is for indication only and not for measuring
operating pressures. Return regulators to minimum.

•Regulator Controls are lockable. Push to lock, Pull to unlock.

2

Page 19 of 66

8.2 Pre-setting alarm limits

 Set the CPAP alarm control to -5 cmH

O and the PIP alarm control to 60 cmH2O

2

8.3 Power On Automatic Test

 Set ventilator mode switch to CPAP.

The ventilator will now carry out a self test as follows.
Power LED shows green and an automatic test of functions & alarms is initialised.

Firstly the displays and audible alarms are turned on for approximately two seconds to
demonstrate that they are operable, then for a further three seconds all the digital
displays show a sequence of numbers from O to 9 before returning to their normal
state.

Note: Block LED does not come on during this sequence.

8.4 Pressure Display

 Set CPAP/PEEP regulator to give 10 cmH

display with the pressure display selector switch in the MIN
position.

 Set the INSP pressure to 40 cmH
 Set the INSP Time to 0.5min

O

2

Ensure that :-

• LED Pressure display reads 10 cmH2O ± 2 cmH2O

• CPAP/PEEP gauge reads ≈10 cmH2O

• Inspiratory cycle is initiated when manual breath button is pressed. (The pressure

display will read 50 cmH2O and then return to 10cmH2O)

Press reset to cancel the cycle fail alarm.

O on the pressure

2

Page 20 of 66

8.5 CMV Mode

 Set the following ventilator conditions :-
 CPAP/PEEP regulator to 10 cmH

 Re-set Inspiratory regulator to ≈30

cmH2O

 Set the Pressure display switch to PEAK

O

2

 Set PIP alarm control to 40 cm H
 Advance the mode switch to CMV

 Set the BPM Rate to 60
 Set the INSP TIME to 0.50

O

2

Ensure that :-

• The ventilator is cycling

• I:E Ratio display reading 1:1

• With the pressure switch check that the mean reads approximately 20 and the peak

reads approximately 40 on the LED.

8.6 PTV Mode

 Set BPM rate to 20 in CMV mode
 Advance the mode switch to PTV
 Set the PTV Sensitivity control to 1

Ensure that :-

• V entilator should continue to cycle

•BPM display reading is initially 0

• TRIGGER BACK-UP LED is “on”

Page 21 of 66

 Apply slight pressure to test lung and release to simulate patient inspiratory effort.

Ensure that with each operation :-

• The ventilator cycles once.

• The TRIGGER BACK-UP LED is “OFF”.

Note: It may be necessary to adjust the PTV sensitivity to
achieve correct operation.

Note: The BPM display will show patient effort detected each minute

8.7 SIMV Mode

 Advance the mode switch to SIMV

Ensure that :-

• The ventilator continues to cycle.

• The BPM display shows set rate.

 Gently squeeze and release the test lung to simulate patient breathing.

Ensure that :-

• The ventilator continues to cycle at the set rate but synchronised with the pressure
from test lung.

 Set Pressure Display Selector switch in the Min position.

Page 22 of 66

8.8 Alarm Test

8.8.1 Low CPAP

Set the following ventilator conditions :-

 Return the mode switch to CPAP.
 Set the CPAP/PEEP regulator to ≈5 cmH

O.

2

• Increase the Low CP AP alarm control to 10 cmH2O. The Low
CPAP alarm will sound and the LED in the alarm panel will

illumuniate.

• Reset the Low CPAP alarm control below 5 cmH2O. The
Low CPAP audible alarm will cancel but the LED in the alarm

panel will remain illumuniated.

• Press the reset button to cancel the visual alarm.

8.8.2 High and Cycle Fail Alarm

 Set the PIP alarm control to 30 cmH
 Set the Pressure display switch to PEAK

 Advance the mode switch to CMV

O.

2

The ventilator will start to cycle

 Adjust the Inspiratory pressure regulator to give a pressure of 30 cmH

O on the

2

pressure LED display.

The ventilator is ready for the High and Cycle Fail Alarm tests

• Decrease the PIP alarm control to 20 cmH2O. This will trigger the HIGH visual and
audible alarm and the LEAK visual alarm

• Increase the PIP alarm control to 30 cmH2O. The HIGH visual and audible alarm
and the LEAK visual alarm will continue

• Press the reset button to cancel the alarms.

Note: The Fresh Gas flow is reduced from ≈5LPM to ≈1LPM in
the High Alarm condition.

Page 23 of 66

• Increase the PIP alarm control to 40 cmH2O. The Cycle Fail visual and audible
alarms will be initiated.

• Decrease the PIP alarm control to 30 cmH2O. The Cycle Fail audible alarm will
cancel but the visual alarm will continue.

• Press the reset button to cancel the visual alarm.

• Return the mode switch to CPAP.

• Set Pressure Display Selector switch in the Min position.

Set the CPAP/PEEP regulator to 10 cmH2O.

8.8.3 Leak and Block Alarms

 Remove the hose from the FRESH GAS (TO PATIENT) port.

• The LEAK visual and audible alarm will be initiated.

 Place a finger over the FRESH GAS (TO PATIENT) port.

• The BLOCK visual and audible alarm will be initiated.

• Replace the hose to cancel the alarms

8.8.4 Mains failure alarm

(Do not turn the mode switch to off).

Disconnect mains power by switching off or removing mains plug from power socket.
This should initiate an audible alarm. Reconnect mains power supply, the ventilator
should carry out self test and resume previous mode of operation.

Page 24 of 66

8.8.5 O2 Blender Alarm

Set Blender to 60%. Disconnect air supply from wall outlet, an audible alarm should
be heard from blender. Reconnect air supply, alarm should self cancel. Disconnect
O2 supply, an audible alarm should be heard from blender. Reconnect O2 supply,

alarm should self cancel.

8.9 Condition of O2 Cell.

Set blender to 100% and observe that displayed FIO2 is 100%.
Set blender to 21% and observe that displayed FIO2 is 21%.

If the reading does not reach 100% then the cell requires adjustment.
To adjust the O2 cell reading , set blender control to 100%.

Disconnect air supply hose from the wall socket and allow 3 minutes before adjusting
control on rear panel. See “Rear Panel” on page 43. for position of control).

If unable to set 100%, O2 Cell must be replaced.

Ignore any blender alarms during this adjustment.

8.10 Completing Functional Testing

 Return all the pressure regulators to minimum.
 Set the Pressure display switch to MIN.
 Set the CPAP alarm control to -5 cm

 Turn the mode switch to OFF

Functional testing is now complete.

O and the PIP alarm control to 60 cmH2O.

2

Page 25 of 66

8.11 Basic Set Up

Warning: It is the operator’s responsibility to check the ventilator pressures
prior to changing modes.

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

Warning: Remove the key switch from the rear of the unit when in use to avoid
accidental change of modes.

Step 1. Connect SLE approved patient circuit to the Ventilator and Humidifier.

• For further information see page 44 or instructions supplied with patient
circuit.

• To test the system the patient manifold must be occluded or a Test Lung
fitted.

• Only an SLE approved patient circuit should be used with this equipment

Step 2. Set up the humidifier to manufacturer’s instructions
Step 3. Set the following ventilator conditions :-

 Set the mode switch to OFF
 Set all the pressure regulators to minimum.
 Set the Pressure display switch to MIN.
 Set the CPAP alarm control to -5 cmH

O and the PIP

2

alarm control to 60 cmH2O.

Step 4. Select mode of ventilation to CPAP

The ventilator will now carry out a self test as described on page 20. Ensure that
this test is completed satisfactorily before continuing.

If after completion of the above self test an alarm continues, a red light might
indicate either BLOCK or LEAK in the fresh gas tubing of the patient circuit. Ensure
that all patient fittings are correctly made and secure.

DO NOT CONTINUE UNTIL ALARMS ARE CLEARED

Page 26 of 66

Step 5. (a) Set required O2 concentration by means of O2 Blender

Control. %O2 Oxygen will be monitored and displayed in
Fl02 Digital Display. The unit should now be ready to
connect to a patient.

• Changes will take 30 seconds to stabilise on the FlO2
display.

Oxygen - Clinical use. Oxygen is a drug and should be prescribed as such.
Exposing a baby to elevated concentrations may lead to Retrolental Fibroplasia.

Oxygen - Fire Hazard. Oxygen vigorously supports combustion and it s use
requires special precaution to avoid fire hazards. Keep all sources of ignition
away when oxygen is in use. Do not use oil or grease on oxygen fittings or
where oxygen is used.

8.12 To Use the SLE2000 in CPAP Mode

As in steps 1 to 5 plus:
(a) Increase CPAP/PEEP pressure to required level

These Controls are lockable. Push to lock, Pull to unlock.

• Pressure will be indicated on the digital display.

(b) Set the CPAP alarm to the required level.

8.12.1 Manual breaths in CPAP mode.

Note: Exclusive to CPAP mode.

To set the parameters for the manual breath advance the mode switch to CMV. Set
the Pressure Display switch to Peak. Set the required Inspiratory time. Increase the
INSP. PRESSURE regulator to required pressure. Check by pushing the manual
breath button. Return the Pressure Display switch to Min. Return the mode switch to
CPAP.

Page 27 of 66

8.13 To Use the SLE2000 in CMV Mode

As in steps 1 to 5 and CPAP setup.
(a) Set INSP.TIME to required rate

(displayed in seconds).

(b) Select Pressure Wave Shape

SQUARE or TAPER.

(c) Switch mode switch from CPAP to CMV
Note: Ventilator will start to cycle and the alarms will probably sound - press

MUTE to silence them.

(d) Adjust the BPM to required rate.
(e) Set the pressure display switch to PEAK and increase the INSP. PRESSURE

regulator to the desired level. This is indicated on the digital pressure display.
(f) Set the PIP alarm to required level. Press RESET to clear the alarms.

LOW CPAP is activated if

pressure falls below setting

HIGH will activate if PIP

setting is exceeded by more
than 4 cms. It will also open a
pressure relief valve and

activate

LEAK alarm

CYCLE FAIL will activate if

pressure wave fails to pass
through a threshold which is
automatically set at 4 cms

below the

PIP setting

Page 28 of 66

8.14 Patient Triggered Modes

8.14.1 To use SLE 2000 in PTV and SIMV mode

As in steps 1 to 5 and CPAP setup
(a) Advance the mode switch to CMV
(b) Set PTV sensitivity to 1
(c) Set the BPM control to provide either:-

The desired back-up rate for PTV
or

The desired number of mandatory breaths per minute for SIMV
(d) Advance the mode switch from CMV to PTV or SIMV
Once connected to a patient, increase the PTV sensitivity towards Max until patient

effort triggers the ventilator. This is indicated by the TRIGGER BACK-UP light
extinguishing.

The weaker the patient the higher the sensitivity required.
After 60 seconds with an update every 60 seconds, the BPM LED display will indicate

the number of patient initiated breaths that were delivered in the preceding minute.
Care should be taken not to set the PTV sensitivity too high as it could self trigger.

Note on the set-up for PTV
If currently ventilating a patient in CMV mode and the decision is made to
change to PTV, the BPM must be reduced to approx. 10 BPM. This is done to
enable the patient to trigger the ventilator. Once this has been achieved the
BPM can be increased to approximately 20 BPM below the patients measured
respiratory rate.

This becomes the backup BPM rate.

Page 29 of 66

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Page 30 of 66

Page 31 of 66

9. Ventilator Controls

9.1 Electronic module

9.1.1 Power Switch (5 positions)

OFF- CPAP- CMV- PTV- SIMV

• OFF = All electrical power off.

Note: There is a limited fresh gas supply with power
switch in the OFF position, if ventilator is used with
Headboxes etc. switch to CPAP.

Switching to CPAP. CMV. PTV or SIMV (power on),

POWER LED shows green and an automatic test of functions & alarms is initiated.

Firstly the displays and audible alarms are turned on for approximately two seconds
to demonstrate that they are operable, then for a further three seconds all the digital
displays show a sequence of numbers from O to 9 before returning to their normal
state.

Note: Block LEDs do not come on during this sequence.

9.1.2 System Fail LED

Lights if main microprocessor system or other electronic circuitry fails (See section
on alarms page 39 )

9.1.3 CPAP Mode

FlO2, mean and min airway pressure digital displays. The Manual Breath
pushbutton and associated with it the 'High', 'Low', 'Failure to Cycle' and 'Fresh

Gas' alarms. Also activated is the INSP. Time control for maual breath. The time

of this breath and pressure must be preset by the user. The mean airway pressure
in CPAP will show an average of airway pressures.

9.1.4 CMV Mode

Enables the BPM control and INSP. TIME controls to set and display the rate and
MIT of the ventilator cycles, and from these settings calculates and displays the l:E
ratio.

• If these controls are set outside valid safety limits their respective displays will

flash. The position of last control adjusted should be decreased to bring the
adjustment to valid safety settings and stop the display from flashing.

Page 32 of 66

9.1.5 PTV Mode

Another main feature of the ventilator is its patient trigger system. This functions
without any transducer in the patient circuit, on the principle of monitoring the rate
of change of pressure during the onset of inspiratory effort. In fact it measures
inspiratory flow by this means and not a pressure plateau.

The BPM control no longer functions in this mode. The last
BPM setting in CMV, prior to switching to PTV will be the
back-up rate. (Setting a time window for Apnoea). Additionally
the PTV sensitivity control is activated, all inspiratory efforts at
chosen sensitivity should trigger the ventilator.

However, if the sensitivity is set too low, or the patient fails to
make an inspiratory effort during the back-up time window , the
ventilator will deliver a back-up breath and indicate this by the TRIGGER BACK UP
LED. If the sensitivity is set too high the ventilator could auto trigger at a high rate.

After 60 seconds with an update every 60 seconds, the BPM LED display will
indicate the number of patient initiated breaths that were delivered in the preceding
minute.

In this mode inspiratory times of less than 0.4 seconds are recommended.

• In PTV mode the BPM display will show only patient initiated breaths. To check

back up rate it is necessary to change the mode switch temporarily to CMV.

• To enable an audible back-up bleep, hold the Reset button in during the automatic

test mode on power up.

Note: PTV has a default of 12 breaths per minute, if the mode switch is turned
straight to PTV mode with out stopping on CMV mode to set the back up breath
rate.
This is also the case if there is an interruption to the power supply, the
ventilator will also default to this setting. It will be necessary to change the
mode switch temporarily to CMV to reset the required BPM.

9.1.6 SIMV Mode.

This mode enables BPM control to select and display the maximum number of
breaths, triggered or untriggered, to be delivered by the ventilator.

If the patient fails to trigger the ventilator during the first half of the SIMV time
window, the ventilator will immediately deliver a mandatory breath and indicate this
with an audible bleep. Any additional spontaneous breaths by the patient will be
unsupported by the ventilator.

• To enable an audible back-up bleep, hold the Reset button in during the automatic

test mode on power up.

Page 33 of 66

This SIMV feature of the SLE 2000 functions in the following manner:

The BPM control setting will determine the number of breaths that will be supplied in
each minute. In the period between each of these breaths a time window is opened.
During the first half of this time window, should the patient attempt to make an
inspiratory effort, the ventilator will deliver a single synchronised mandatory breath. If,
however, after the first half of this time window has elapsed the patient has made no
detected effort to breathe the ventilator will then supply a single unsynchronised
mandatory breath and make a short audible bleep.

It is possible to enable the audible bleep made on each mandatory breath in the SIMV
mode. Whilst switching the ventilator mode switch from the OFF position to SIMV,
and during the initial ventilator system check, when the digital displays run the their
numerical check, the RESET button is held in. This will enable the audible bleep, until
the ventilator is switched OFF again.

The ventilator will only supply one breath during each time period set by the BPM rate.
So the total number of breaths delivered either synchronised or mandatory will be only
that shown in the BPM display.

If an inspirating effort is
detected during SIMV
period, ventilator will
deliver a synchronised
breath. All further
spontaneous breaths
during this time window are
not assisted.

Page 34 of 66

If patient fails to make an
effort during SIMV period,
ventilator will deliver a
mandatory breath at start
of mandatory period, any
further efforts during time
window are ignored.

Patient triggers breath at
start of time window and
ventilator will ignore all
breaths until this time
window has elapsed.

9.1.7 BPM

Ten-turn control with LED digital
indication to set the breath rate
per minute.

9.1.8 Inspiration Time

Set by ten-turn control with
indication on 3 digit LED display
showing the set value in seconds.

Invalid settings of the BPM. and INSP.TIME controls are indicated by these two
displays flashing. The ventilator will not allow the expiration time to be set to less
than 0.25 seconds.
Two ranges controlled by the rear BPM range switch

0.1-3.0 secs (1-125 BPM range) setting resolution 0.02 secs

0.01-0.3 secs (126-250 BPM range) setting resolution 0.01 secs

9.1.9 I:E Ratio

This appears on a four digit LED display and is calculated from
the settings of the BPM and the INSP.TIME controls.

• If the BPM and the INSP TIMES are set so that the l:E ratio

exceeds 9.9:1 or 1:9.9, the display will show four dashes. This
will also occur in the PTV Mode.

9.1.10 Oxygen (FlO2)

Indication of the oxygen concentration of the Fresh Gas supply to
the patient appears on a 3 digit LED display. Should the indication
fall below 18% the display will flash.

Recalibration at 100% O2 is effected by rear panel screwdriver
adjustment. See page 43

9.1.11 Pressure Display

Digital LED indication ±65 cm/H20

Page 35 of 66

9.1.12 Three position switch.

For selecting display of PEAK (maximum), MEAN, or MIN
(Minimum) airway pressures.

9.1.13 Pressure Wave Switch

This switch alters the pressure waveform
from square to tapered as indicated.

• This is a Locking Toggle Switch. Pull toggle lever to release.

• The ventilator should be set to a square waveform for breathing rates above 60

BPM.

9.1.14 Manual Breath

The manual breath push button functions in the

CPAP, CMV and PTV modes, with the High pressure and Failure to
Cycle alarms operative.

• The duration of the Manual Breath is controlled by the INSP. TIME

setting.

Manual

Breath

Page 36 of 66

9.2 Pneumatic Module

9.2.1 Proximal Airway

Input from patient ET connector to pressure display and internal
pressure transducers.

9.2.2 Removable Exhalation Block N2190

Can be removed easily for cleaning by lowering side panel.

Pressure release valve

9.2.3 Fresh Gas Port

The Fresh Gas port supplies 5 LPM of the blended gas via the
humidifier to the patient inspiratory port on the ET connector
when the ventilator is switched on.

Page 37 of 66

9.2.4 Regulator and Pressure Gauges.

• These 2 pressure regulator controls have push/pull locking caps.

CPAP/PEEP

This regulator controls the base pressure in the circuit.

INSP. PRESSURE

This regulator controls the peak inspiratory pressure (PIP).

SYSTEM DRIVING PRESSURE

This guage shows the pressure above CPAP/PEEP.

9.2.5 O2 Blender (% FlO2)

The oxygen blender controls the amount of oxygen available
in the fresh gas supply. The blender is monitored separately
by an internal analyser and displayed on the FlO2 digital

display.

There is an option (Option 3) for a blended gas output
connected on the side of the unit.

Note: This output provides up to 15 LPM Blended gas
controlled by the O2% control

Page 38 of 66

10. Alarms

Warning Audible and V isual warning alarms indicate a potentially harmful
condition to the patient . Failure to take corrective action could result in injury
or death to the patient.

10.0.1 Microprocessor

The microprocessor system failure and other electronic circuitry failures are
alarmed as follows.

The microprocessor carries out a self check every 20 ms, and should a failure be
detected the 'SYSTEM FAIL' LED will start to flash and the processor will attempt
to reset itself. There is a secondary watchdog alarm independent of the above
system which is reset by the main processor every 20 ms. Should the processor
fail to reset this watchdog within 3 seconds then a HIGH FREQUENCY alarm will
pulse at 2 Hz. This alarm can only be cancelled by switching the ventilator off.

Other hardware system checks are incorporated such as the
monitoring of the solenoid driver circuitry. If the solenoid driver
fails to operate when the processor has initiated a solenoid valve
closure or opening, 'SOL' will appear in the BPM display window.
All the front panel potentiometers are frequently checked for
continuity. If a defect is found then, 'HELP' appears in the l:E
ratio display window and the solenoid is de-energised.

Further checks are made on the processor associated hardware, and again if any
fault is detected the solenoid is de-energised and ‘HELP’ is displayed in the l:E
ratio display window.

10.0.2 Mains Failure Audible Alarm

Active when the mode switch is in any position except OFF and will alarm if mains
voltage supply fails.

10.0.3 Gas Supply Failure Alarm

The Air and Oxygen audible alarms are an integral part of the blender, and function
when AIR or O2 pressures differ by more than 30 PSI and if either gas is

disconnected.

Page 39 of 66

10.0.4 Fresh Gas Fail Alarm (Block & Leak)

This fresh gas failure system will detect either a blockage or a leak in the Fresh Gas
supply line. To achieve this there is a small restrictor fitted in the Inspiratory Port of
the patient circuit, creating a pressure in the alarm circuitry to the Electronics
Module. Should the Fresh Gas supply to the patient fail, visual and audible alarms

will activate. The Fresh Gas LEAK LED will illuminate and the audible alarms will
operate. This alarm will reset when the gas flow is restored. Similarly the Fresh
Gas BLOCK LED will illuminate and the alarm will sound, should there be a
blockage in the patient gas supply, and a high pressure relief valve will be
activated.

10.0.5 Adjustable Alarm

Two controls on the front panel control the settings for HIGH/CYCLE FAIL and
LOW alarms.

10.0.6 High Alarm

Should the airway pressure exceed the PIP alarm setting by more than 4 cms,
audible and visual alarms will be activated, a system leak will be introduced to vent
excessive pressure and the fresh gas supply will be cut off. HIGH pressure alarms
can only be cleared and fresh gas returned by reducing airway pressure then
pressing the RESET button.

10.0.7 CYCLE FAIL ALARM

This alarm will be activated should the pressure wave fail to pass through a
threshold 4 cms below the PIP setting on either inspiration or expiration, indicating
a drop in airway pressure, a leak or circuit blockage. The audible alarm will reset
automatically on correct pressure being restored but the visual alarm must be
RESET by pressing the reset button.

Page 40 of 66

10.0.8 Low CPAP Alarm

Should the circuit pressure fall below the LOW CP AP alarm setting then an audible
and visual alarm will be activated. The audible alarm will reset automatically on
correct pressure being restored but the visual alarm must be reset by pressing the

RESET button.

10.0.9 O2 Blender Alarm

This is a mechanical alarm and will sound when the pressure difference between
the supply gasses is greater than 30psi, indicating a possible gas supply failure.

10.0.10 Alarm Mute

This button will mute the audible alarms of PATIENT GAS FAILURES, CYCLE
F AIL, LOW PRESSURE, and HIGH PRESSURE for a period of 60 seconds, but
can be reset by the RESET push button, providing no alarm condition exists.

10.0.11 Alarm Volume

The main high frequency alarm volume is factory pre set which is not user
adjustable.

10.0.12 Alarm Verification

For the procedure for verifying the alarms see page 23.

Page 41 of 66

11. Auxiliary Output

Warning No external voltage should be applied to the auxiliary socket. Any
connections to this socket must be approved by SLE and screened to comply
with EMC regulations. Ensure protection cap is fitted when socket is not in use.

Analogue signal outputs are available at the rear of the electronics module, on the 7
pin DIN connector Auxiliary O/P.

Buffered airway pressure. Pin 1 1 - 7 volts corresponding to 0 to 60 cmH2O

FIO

2.

Common ground. Pin 3
All other pins must be left unconnected. SLE reserve the right to use these pins for

other uses.

• Only SLE approved equipment may be connected to this auxiliary output socket.

Pin 2 0 - 4 volts corresponding to 0 to 100%

Page 42 of 66

SLE
232 SELSDON ROAD
SOUTH CROYDON
SURREY CR2 6PL U.K.
TYPE Nº
SERIAL Nº
SUPPY V ~ Hz
POWER A
CLASS TYPE

12. Rear Panel

Auxiliary Output Connector

Alarm Sounder

FI02 100% Adjustment Tool

Running Time indicator

Gas Inlet Ports

Range switch

FI02 100% Adjustment

FuseHolders

CAUTION- ELECTRIC SHOCK HAZARD. DO NOT REMOVE COVERS
PERSONNEL.

DISCONNECT ELECTRICAL SUPPLY

CAUTION- FIRE HAZARD. ENSURE FAN OUTLETS ARE FREE FROM

DANGER - EXPLOSION HAZARD. DO NOT USE IN THE PRESENCE

THIS EQUIPMENT SHOULD ONLY BE USED BY SUITABLY TRAINED
AND CLINICALLY AUTHORISED PERSONNEL.

OR PANELS. REFER SERVICING TO QUALIFIED

BEFORE SERVICING

OBSTRUCTION. CHANGE FAN FILTERS REGULARLY
(SEE USER MANUAL)

OF FLAMMABLE ANAESTHETICS.

Page 43 of 66

13. Patient Circuit Connection

SINGLE USE HEATED PATIENT CIRCUIT (SLE Part Nº N2188)

Temperature port 450mm from ET Manifold.This non-sterile circuit is for single
patient use only. It is designed to be used with an SLE2000 or SLE2000HFO
Infant Ventilator in combination with a Servo controlled humidifier - typically
SLE3000, Fisher and Paykel or equivalent.

DIRECTIONS FOR USE CAUTIONS

It is recommended that a high quality bacteria filter (SLE part
No. N2029) is fitted at the fresh gas connection to the
humidifier inlet, however the circuit may be used without.
Connect the patient circuit as shown in the diagram and
described below. Drain water trap regularly by removing the
bottom cup. (Circuit pressure is not lost when cup is
removed).

1.HUMIDIFIER SUPPLY LINE
If a bacteria filter is being used, fit the very short piece of
transparent tube to the ventilator outlet marked “Fresh Gas to
Patient”. Fit the bacteria filter into this tube. Take the loose
length of blue pipe and connect the small end of this to the
bacteria filter and the larger end to the humidifier inlet. If a
bacteria filter is not being used, connect the loose length of
blue tube directly between the “Fresh Gas to Patient”
ventilator outlet and the humidifier inlet.

2. INSPIRATORY SUPPLY LINE
Take the main patient circuit and fit the blue tube with the
large connector to the humidifier outlet. Plug the electrical
connector into the humidifier heated wire supply.

3. EXPIRATORY SUPPLY LINE
Take the clear tube with the large connector and fit to the
exhalation port of the ventilator. Position water trap in an
upright position at the lowest point in the circuit limb.

4. PROXIMAL AIRWAY PRESSURE LINE
Connect the small diameter clear tube from the patient circuit
to the proximal airway port on the ventilator.

Make sure that all connections are made properly and are
tight before use.
For circuit heating, follow the directions provided with the
humidifier.
Do not use in applications where gas temperature at outlet of
humidifier exceeds 55ºC.
Do not cover the patient circuit with anything which may
cause the tube to overheat.
Avoid resting the patient circuit against patient skin.
Keep water trap upright with cup at bottom.
Make sure the drain cup is secure.

5. TEMPERATURE MONITORING
Two ports are provided for dual temperature probes, one in
the connector on the humidifier outlet (next to the heated
wire inlet) and a second port in the blue tube close to the ET
connector.

DIAGRAM INDEX

A. Proximal Airway
B. Exhalation Port (from patient)
C. Short Tube
D. Single Use Bacteria Filter SLE Part Nº N2587 or N2187
E. Autoclavable Bacteria Filter SLE Part NºN2029
F. ET Manifold
G. Red Restrictor
H. To Heater Wire Adaptor
J. Humidification Chamber
K. Water Trap

Page 44 of 66

REUSABLE 10mm HEATED PATIENT CIRCUIT (SLE Part Nº N2391)

This circuit must be clean and sterilised before use. It is designed to be used

with an SLE 2000 or SLE2000HFO Infant V entilator in combination with a Servo

controlled humidifier - typically a Fisher and Paykel or equivalent..

DIRECTIONS FOR USE CAUTIONS

Clean and sterilise before and after subsequent use of 7
days maximum. It is recommended that a high quality
bacteria filter (SLE part no. N2029) is fitted at the fresh gas
connection to the humidifier inlet, however the circuit may be
used without. Connect the patient circuit as shown in the
diagram and described below. Drain water trap regularly by
removing the bottom cup. (Circuit pressure is not lost when
cup is removed).

1. HUMIDIFIER SUPPLY LINE
If a bacteria filter is being used, fit the short piece of tube
ITEM C to the ventilator outlet marked ‘Fresh Gas to Patient’.
Fit the bacteria filter into this tube. Take th e loose length of
tube ITEM 1 and connect the free end of this to the bacteria
filter and the adaptor end to the humidifier inlet. If a bacteria
filter is not being used, connect the loose length of tube ITEM
1 directly between the ‘Fresh Gas to Patient’ ventilator outlet
and the humidifier inlet.

2. INSPIRATORY SUPPLY LINE
Take the main patient circuit and fit the tube with the large
connector to the humidifier outlet. Plug the humidifier heated
wire supply onto electrical connector ITEM H

3. EXPIRATORY SUPPLY LINE
T ake the tube with the connector and fit to the exhalation port
of the ventilator. Position water trap in an upright position at
the lowest point in the circuit limb.

4. PROXIMAL AIRWAY PRESSURE LINE
Connect the small diameter clear tube from the patient circuit
to the proximal airway port on the ventilator.

5. TEMPERATURE MONITORING
Two ports are provided for dual temperature probes, one in
the connector on the humidifier outlet (next to the heated
wire inlet) and a second port in the ET Manifold ITEM 5.
STERILISING (Maximum Temperature 134°C)
Dismantle circuit parts and water container for cleaning.
Steam autoclave only, at a recommended temperature of
121°C for 20 minutes.Allow 15 minutes dry time and return to
ambient temperature before assembly and use.

Make sure that all connections are made properly and are
tight before use.
For circuit heating, follow the directions provided with the
humidifier
Do not use in applications where gas temp. at outlet of
humidifier exceeds 55ºC.
Do not cover the patient circuit with anything which may
cause the tube to overheat.
Do not autoclave water trap if medications containing
chlorinated or aromatic hydrocarbons are used or with the
water container fitted.
Avoid resting the patient circuit against patient skin
Keep water trap upright with cup at bottom. Empty container
before water reaches MAX Level Line. Make sure the drain
cup is secure.

DIAGRAM INDEX
A Proximal Airway Inlet
B Exhalation Port (Fr om Patient)
C Ø10 x 100 Tube Assembly Part Nº N2998/04
D Single Use Bacteria Filter - Optional Part Nº N2187 or
N2587
E Autoclavable Bacteria Filter - Optional Part Nº N2029
F ET Manifold Part NºN3145
G Red Metal Restrictor Part NºN2266
H Heater Connection - Dual Servo Hose Assy Part Nº N3510
J Hu m idifie r Chamber - Re f erence o nly
K Water Trap Part Nº N3139
T Temperature Probe - Reference only
1 Humidifier Supply Line - Ø10 x 610 Part Nº N2998/24
2 Inspiratory Supply Line - Ø10 x 250 Pt No.N2998/10 &
Ø10 x 1220 Pt No.N2998/48
3 Expiratory Supply Line - Ø10 x 760 Pt No.N2998/30
(x2)+Adaptor No.N3148 (x5)
4 Proximal Airway Pressure Line - i/Ø 1/8” x o/Ø 1/4” x 1830
Part Nº.N2030

5 Temperature Monitoring - Probe Port H ousing Tee Part Nº
N3146
6 Inspiratory Supply Line - Ø10 x 100 Tube Assembly Part Nº
N2998/04
11 Hose Clips - Secure Temperature Probe Lead Part Nº
N3049
12 Draw Wire - Tool for Assembly of Heater Wire. Part Nº
N3071

Page 45 of 66

14. Filter Systems

IIt is recommended that bacteria filters are
fitted in the fresh gas supply and on the
patient side of the exhalation block.

The filters reduce the possibility of infection
to the patient and contamination of the
ventilator from secretions or fluids in the
breathing circuits that could accidentally
enter the ventilators gas ports.

It is recommended that a silencer be fitted

Bacteria
Filter N2029

Bacteria Filter
N2587

The SLE2000 can be used without bacterial filters in place, but the user must take
extra care in not allowing secretions or fluids to enter the ventilators gas ports.

14.1 Bacterial filter, SLE Part Nº:N2029 (Autoclavable)

This autoclavable bacterial filter is fitted into the humidifier supply line and has to be
fitted in accordance with the indicator arrow embossed on the surface of the filter.

on the exhaust side of the exhalation block,
this helps to reduce the noise level of the
system.

Do not immerse the filter in any liquid.

Autoclave with pure dry saturated steam at:
134ºC (277ºF) (Allowable variation of temperature of +3ºC) at 220kPa (32psi) with a
minimum holding time of 3 minutes

or
121ºC (248ºF) (Allowable variation of temperature of +3ºC) at 96kPa (14.1psi) with a
minimum holding time of 15 minutes.

The filter can be autocalved a maximum of 25 times within its anticipated service life
of 12 months. For other makes of

bacterial filter please refer to manufacturers

instructions.

14.2 Bacterial filter, SLE Part Nº:N2587 (Single use)

This single use bacterial filter is fitted onto the exhalation block outlet. This filter
should be disposed of in accordance with local hospital authority guidelines. A new
filter should be used for every new patient.

14.2.1 Precautions when using bacterial filter N2587

The user should be aware that any occlusion of the filter increases the resistance to
airflow , resulting in increased or erratic airway pressures. Airway pressures should be
monitored during use and the filter changed if found to be contaminated in any way.
When using humidification the filter should be checked regularly for signs of water
build up which could cause occlusion.

Page 46 of 66

15. Cleaning, Disinfection and Sterilization

All cleaning, disinfection and sterilizing should be carried out under the direction of the
appropriate hospital authority.

DO NOT allow moisture to enter the electronic module or its electrical sockets.
Electronic malfunction may result.

DO NOT steam autoclave the SLE 2000 or otherwise subject it to temperatures above
62°C.

DO NOT immerse any part of the SLE 2000 in any liquid, with the exception of the
expiratory exhalation block (SLE part No N2190).

15.1 Preparation of a new ventilator

Remove all transit packaging. Inspect the fresh gas port and proximal airway port for
any packing material. (Retain packaging for future use as the ventilator must be
returned in its original box).

Remove the protective film from the LCD screen.
Clean, disinfect and sterilize in accordance with the instructions in section 15.2 .
Remove the inlet air and O2 gas port caps. (Retain for future use).

15.2 Cleaning and disinfection of an in-service ventilator

The table 1 outlines the areas of the ventilator which can be uniquely cleaned,
disinfected and sterilized.

Before cleaning or disinfecting the exterior of the ventilator the following tasks should
be performed:

• The mains cable should be disconnected from the mains supply.

• Remove the patient circuit and bacterial filters. Discard any single use items
as per appropriate hospital authority guidelines. Reusable items should be
processed as per appropriate hospital authority guidelines and the
manufacturers instructions.

• Disconnect the gas supplies from the wall outlets.

• Disconnect the Oxygen and Air hoses from the ventilator and cap the inlet
ports.

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• Lift up lever (A) on side of ventilator
and lower side flap.

A

• Remove the silencer (B) by pulling
it through the hole at the rear.

• Remove the exhalation block (C)
by firstly taking hold of the block
and then pulling it out towards you
without the need for undue force.

Refitting the silencer and exhalation block is the reversal of removal. Do not force the

exhalation block into place.

15.2.1 Cleaning, Disinfection & Sterilization chart

Item Clean Disinfect Sterilize
Ventilator Yes Yes
Silencer Yes
Exhalation block Yes Yes Yes

Table 1

B

C

Warnings (General): Do not insert any object (such as a needle) in to the gas
ports. This action will result in damage to the port. If the user believes there is a
foreign object in a gas port, please refer the ventilator to qualified service
personnel for inspection and repair.

Note: The silencer should be autoclaved only. If the silencer is found to have
visual contamination internally, discard and replace with a new silencer.

15.3 Cleaning method

Note: Cleaning is an essential prerequisite to disinfection and sterilization.
Ventilator. For cleaning use three clean, disposable, absorbent, non-shedding cloths.

Wipe clean with the first cloth using a hand hot water/mild general purpose detergent
solution (as prescribed by the appropriate hospital authority). Do not overload the
cloth with liquid. Remove the water/mild general purpose detergent solution with the
second cloth using water only. Do not overload the cloth with liquid. Wipe dry with the
remaining cloth. Care should be taken to ensure that the ventilator gas jets in the ports
are not blocked by any debris.

Exhalation block. The exhalation block can be immersed and agitated in the
detergent solution. Do not insert any objects into the exhalation block. Rinse the
exhalation block in clean water, it must be allowed to dry thoroughly before
sterilization.

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Warning: Ensure that the detergent solution or water does not enter the unit or
the exhalation block gas ports on the side of the machine.

15.4 Disinfection method

Note: Alcohols such as 70% isopropanol have a good activity against bacteria
and viruses. They should only be used after all visible surface dirt has been
removed from the area to be disinfected.

Ventilator. For disinfection use two clean, disposable, absorbent, non-shedding

cloths. Wipe clean with the first cloth using Alcohol (70% isopropanol). Wipe dry with
the remaining cloth.

Exhalation block. The exhalation block can be immersed in Alcohol (70%
isopropanol). The exhalation block must be allowed to dry thoroughly before
sterilization.

15.5 Sterilization method

The silencer SLE part Nº N2186 and exhalation block SLE part Nº N2190 must be
sterilized between use on patients. The ventilator cannot be sterilized.

The exhalation block must be cleaned as an essential prerequisite to sterilization.
Autoclave with pure dry saturated steam at:
134ºC (277ºF) (Allowable variation of temperature of +3ºC) at 220kPa (32psi) with a

minimum holding time of 3 minutes

or
121ºC (248ºF) (Allowable variation of temperature of +3ºC) at 96kPa (14.1psi) with a
minimum holding time of 15 minutes.

There is no limit on number of autoclave cycles for the exhalation block.
The silencer can be autoclaved up to 20 times. The body of the silencer should be

marked after each autoclave cycle with a high temperature, water proof, permanent
maker to indicate number of sterilization cycles completed.

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16. User Operational Checks

1. Functional test as described on page 19 should be carried out every time the

patient circuit is changed.

2. Check the running time meter on the rear of the ventilator to see if preventative

maintenance or overhaul is due. Arrange if necessary.

3. It is the users responsibility to ensure that the ventilator is maintained in accordance

with the service programme;
Preventative maintenance : 6 monthly
Overhaul : 10,000 hours or 24 monthly.

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17. SLE2000 Trouble Shooting Chart

Symptom Possible Cause Remedy

Leak Alarm - audible
& visual

Block Alarm ­audible & visual

Blender Alarm ­audible when both
gases connected.

Incorrect circuit fitted.

Damaged circuit fitted.
Humidifier chamber.
High alarm condition.

Fresh gas supply has
decreased.

Leak alarm drift
Fresh gas filter blocked.

Fresh gas restrictor blocked.
Alarm shuttle sticking.

Replace with correct circuit
P/No. N2188 or variant.

Replace with new circuit.
Replace chamber.
High alarm LED illuminated

Reset Insp. pressure and/or
adjust High alarm parameter

Consult Service Manual.

Consult Service Manual.
Replace filter.
Replace circuit.

Remove both gases from supply
and re-connect O

does not work, disconnect and
then connect the Air first.
Consult SLE trained Engineer if
alarm persists.

first. If this

2

High Alarm - audible
& visual

Either Air or O2 gas has failed

Air/O2 differential pressure
exceeded.

Incorrect PIP alarm setting. Readjust alarm to INSP

Repair gas supply
Check that the difference in

pressure between the two
gasses is less then 30 PSI.

PRESSURE or readjust INSP
Pressure regulator.

Page 51 of 66

Symptom Possible Cause Remedy

Cycle Fail Alarm ­audible & visual.

System Fail ­audible & visual.

CPAP
Unable to set
desired pressure.

Incorrect PIP alarm setting.

Proximal Airway line
disconnected.

Proximal Airway blocked with
water.

Solenoid failure.

Component failure As above.

Faulty patient circuit.
Incorrectly assembled patient

circuit.
Exhalation block - located

incorrectly.

Readjuct PIP alarm to INSp
pressure. Check sent vent
pressure.

Reconnect tubing.

Clear blockage.

Consult Service Manual or SLE
trained Engineer.

Replace circuit.
Reassemble as per drawing

supplied with circuit.
Relocate the block assembly.

Regulator cap is in LOCKED
position.

Seized regulator control.

CPAP nozzle blocked.

Pull regulator cap out to release
from locked status.

Consult SLE trained Engineer.

Consult SLE trained Engineer.

Page 52 of 66

Symptom Possible Cause Remedy

PEAK INSP.
PRESSURE
Unable to set
desired pressure.

HELP message.
Displayed in I:E
window

Faulty patient circuit.
Incorrectly assembled patient

circuit.
Exhalation block - located

incorrectly.
Regulator cap is in LOCKED

position.

Seized regulator control.
Insp. nozzle blocked.

High alarm condition.
Water in proximal airway

pressure tubing
System failure Consult SLE trained Engineer.

Replace circuit.
Reassemble as per drawing

supplied with circuit.
Relocate the block assembly.

Pull regulator cap out to release
from locked status.

Consult SLE trained Engineer.
Consult SLE trained Engineer.
Reset alarm setting.
Drain tube

SOL message
displayed in BPM
window.

Varying pressures Check for blocked or water

Waveform has a
slow rise time.

System failure Consult SLE trained Engineer.

logged filters.
Water in proximal airway line. Replace patient circuit.

Replace filters

Consult SLE trained Engineer.

Page 53 of 66

18. Service Programmes

Service or calibration of this ventilator should only be carried out by an SLE trained
hospital engineer or an SLE service engineer.

To assist in checking operational use and service periods, the ventilator is fitted with a
time elapsed meter. Times should be noted when any service or major component
replacement is carried out on individual units.

6 MONTHLY PREVENTATIVE MAINTENANCE

Preventative maintenance should be completed at a maximum of every 6 monthls.
This maintenance is intended to be carried out in the hospital. Preventative
Maintenance will include:-

• Visual inspection of and cleaning of all exterior surfaces, controls, attachments and

accessories.

• Removing the covers and cleaning all dust from interior of the unit.

• Visual inspection and replacement where necessary, of all tubing, electrical wiring,

connectors, crimps, screws, nuts, hardware and checking the general condition of

all other internal components and assemblies.

• Inspection of the mains failure battery holder for corrosion and replacement of the

battery.

• Pneumatic and Electronic testing and where necessary, calibration of ventilator.

• A maintenance agreement is available. Contact your distributor for further details.
10,000 Hrs (24 MONTHLY) OVERHAUL

Overhaul should be carried out at a maximum of 10,000 hours operation or every two
years of service. This overhaul must be performed by an SLE trained hospital
engineer or an SLE service engineer.

In addition to the checks and items performed during the preventative maintenance,
an overhaul will include replacement of :-

• Oxygen monitor cell

• Oxygen blender

• Main solenoid SV1

• PIP and CPAP regulators

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Checking operation and general condition and replacing where necessary the
following components:

• Solenoid valves SV2, SV3, and SV4

• Tubing and connectors.

• Battery holder.

• Alarm sounders.

• Mode, wave shape, frequency range and pressure range switches.

• Pressure relief valves.

• A service manual including circuit diagrams descriptions of operations, part s

lists etc., is available for use by qualified engineers who have been trained by

SLE on this product. Contact your distributor for further information.

• SLE can offer an exchange service for the complete pneumatic module.

Page 55 of 66

19. Pressure unit conversion constants

PSI

a

k Pascal bar

PSI 1.000 6.8947
k Pascal 0.14504 1.000

6.8947 x 10

10.000 x 10

cmH2O

-2

70.308 51.715

-3

10.1973 7.5006

b

bar 14.5 100 1.000 1019.73 750.06
cmH2O 1.42237 x

-2

10

mmHg 1.9337 x

-2

10

0.09806

0.13332

9.806 x 10

1.3332 x 10

-4

1.000 0.7355

-3

1.3595 1.000

For example : To convert PSI to cmH2O multiply by 70.308

Notes:

a. PSI - pound per square inch

b. at 4 oC

mmHg

c

c. at 0 oC

Page 56 of 66

20. Technical Specification

20.1 Conventional Ventilation

Modes: CPAP,CMV,PTV,SIMV
BPM Ranges: 1-125 or 126 - 250 breaths per minute (1BPM

STEPS) selected via rear security key switch
Inspiratory Time: 0.1-3.0 or 0.01-0.3 seconds
I:E Range : 9.9:1 - 1:9.9 calculated from BPM and INSP.

TIME settings.
CPAP Pressure: 0 cmH2O to 15 cmH2O minimum.

Inspiratory Pressure: 0 cmH2O to 60 cmH2O

switched fast or slow rise waveforms.

20.2 Displays

Proximal Airway Pressure Gauge Gauge range -6 to +60 cmH2O
Seven segment LED’s: showing BPM, INSP. TIME, I:E RATIO, FIO2

and PRESSURE (max., mean or min.).

Indicator LEDs: POWER: green LED indicates power on.

SYSTEM F AIL: Indicates main processor
system fail.
TRIGGER BACK-UP: Indicates a machine
delivered breath if patient fails to trigger
ventilator during back-up time window .
MAX., MEAN, MIN.: indicates which value is
being displayed on the 7 segment pressure
display.
MUTE: Indicates that the mute function is
active.

Alarm LED’s LOW CP AP : warning of the pressure dropping

below the LOW CPAP alarm limit
CYCLE FAIL: warning that no breath has been
detected. Ventilator breath is below alarm
threshold.
HIGH: warning of the PIP alarm limit being
exceeded
BLOCK: warning of a block in the fresh gas
supply limb of patient circuit.
LEAK : warning of a leak in the fresh gas
supply limb of the patient circuit.

Driving Pressure Gauge:
(Scaled for resultant inspiratory
pressures above PEEP)

Gauge range :0-60 cmH2O plus PEEP level

Page 57 of 66

20.3 Controls

Ventilation mode switch: OFF, ALARM TEST/CPAP, CMV, PTV, SIMV
BPM Control (ten turn): either 1-125BPM or 126-250BPM
INSP. TIME Control (ten turn): either 0.10-3.00 seconds (min exp time: 0.25

seconds) or 0.01-0.3 seconds (min exp time:

0.12)
Pressure Display Switch: MAX., MEAN, MIN.
Pressure Wave Switch: Slow or Fast rise
Manual Breath Pushbutton
Alarm Mute and Reset

Pushbuttons:
Trigger Sensitivity Control: Range: 2ml/0.5 sec max. To 10ml/0.5sec min.

Pressure alarm setting controls: LOW CPAP: -5 to 15cmH2O

Pressure controls: INSPIRATORY

Air/Oxygen Blender Control 21-100% ± 3%

Mute active for 60 seconds (approx.)

Using SLE N2188 patient circuit.

PIP :10 to 60 cmH2O

CPAP/PEEP

Page 58 of 66

20.4 Alarms

Audible only:
Loss of mains supply: Battery powered alarm

Loss of Air or O2 supply: Blender alarm.

Audible and Visual:

HIGH CIRCUIT PRESSURE
CYCLE FAIL
LOW CIRCUIT PRESSURE
FRESH GAS BLOCK
FRESH GAS LEAK or TOTAL GAS SUPPLY
FAIL SYSTEM FAIL: FAIL.

20.5 Air and Oxygen Supplies

The SLE2000 HFO infant ventilator is designed to be use with medical grade
compressed air and oxygen.

20.5.1 Oxygen supply

The SLE2000 HFO requires a supply of pure oxygen between 3 to 5 bar.

20.5.2 Air supply

The SLE2000 HFO requires a supply of medical grade compressed air to ISO8573.1
Class 1.4.1 (minimum level of filtration) between 3 to 5 bar. Recommended level of
filtration is class 1.1.1.

Description of Class 1.4.1

1= particle size of 0.1 microns. 4 = Pressure dewpoint of +3ºC . 1= oil content 0.01Mg/
m3

Description of Class 1.1.1

1= particle size of 0.1 microns. 1 = Pressure dewpoint of -70ºC . 1= oil content

0.01Mg/m3

Page 59 of 66

20.6 Power , Dimensions etc.

Voltage : 100-120V/ 50-60 Hz

220-250V/ 50-60 Hz
Power : 120 VA
Fuses : 220-250V~50-60 Hz : Fuse T 1.0A

100-120V~50-60 Hz : Fuse T 2.0A
Operating Environment: Temp: 10-40°C

Humidity: 0-90% (non condensing)
Size, Ventilator only : 37 cms W × 31 cms H × 32 cms D
Height on pole: 137 cms
Weight Ventilator Only: 10 Kgs
Complies with: CE DECLARATION OF CONFORMITY

IEC 601-1 and 601-2-12 1988

BS 5724 Part 1 and section 2.12.1990

EMC Medical device 601-1-2
Patient Circuit Required: Model : N2188 Single use. or variant

Model : N2200 Re-usable. or variant
Transport and storage conditions Temperature -20 to 50“C for not longer than 2.5

months

Humidity 15 to 90% (non condensing) for not

longer than 2.5 months

Atmospheric pressure 500 to 1060hPa for not

longer than 2.5 months
Protection Class 1 T ype B Protection against electric

Shock
Mode of operation Continuous

Page 60 of 66

21. Consumables and Accessories for SLE 2000

MR700 Heater Base usable with all appropriate items
listed below

N3700/01 (230V)
N3700/02 (100V)
N3700/03 (115V)

N3220 -MR220 Single use chamber
(Box of 50) for use with above

N2188 - Standard Single use Patient Circuits for use with
above (Box of 30) Other configurations available

N3557 MR557
Heater Adapter for use with above single use patient
circuits & chambers

N3340 -MR340 Re-usable chamber
for use with above

N2391 - Re-Usable Patient Circuit for use with above

N2200 - Re-Usable Patient Circuit Accessory Kit

N3558 MR558 Heater Adapter for use with above
re-usable patient circuits & chambers

N3170 MR170 Pole Clamp for MR700 heater base

N3560 MR560 Dual Temperature Probe

Page 61 of 66

N2190 Spare exhalation Block

N2029 Bacteria filter (autoclavable)

N2587 Bacteria filter (single use)

Inlet :22mm (male) Outlet 22mm (female)
N2187 Bacteria filter (single use)
Inlet & Outlet:15mm (female) or 22mm (male) Tapered

Connections
N2186 Silencer (fitted to rear of exhalation block)

N2035 O2 (complete) 4 metres length

N2199 Air hose, 4 bar (complete) 4 metres length

N2006/11 User Manual for SLE2000
N2000/00 Service Manual for SLE2000
N2002/01 User Manual for SLE2000 on CD-ROM
N2002 Service Manual for SLE2000 on CD-ROM

Page 62 of 66

22. Ordering Information

SLE 2000* Z2002 Stand mounted Ventilator ( without humidifier), Hoses,

Manual and Single Use Circuits (Qty 3)

SLE 2000* Z2102 As above but for Shelf mounted Ventilator ( without

humidifier)
SLE 2000* Z2202 As above but for Rail mounted Ventilator ( without humidifier)
*State voltage required
OPTIONS**

Option 1 ref. N2200 Reusable circuit start-up kit (Part No. N2200).

Option 3 ref. Z0003 Auxiliary 0-15 LPM Blended Output.

**State operation required

Air Compressors

AD 3600, ref. L0035 Suitable for 1 Ventilator
AD 2000, ref. L0030 Suitable for 2 Ventilators

Page 63 of 66

23. Technical Bulletins

Listed below are all the technical bulletins that are relevant to the SLE2000 infant
ventilator.

TB 990603: Removal of hour counter from electrical chassis.
TB 000201: New versions of control software
TB 000801: Ventilator firmware revision list
TB 040301: CPU Boards for serial Nº: E0108 & Y0963 to Y0975
TB 040401: V0226 potentiometer design change

Any of the above technical bulletins can be obtained by contacting the SLE Service
Department.

Page 64 of 66

SLE reserves the right to make changes without prior notice in equipment,

publications and prices as may be deemed necessary or desirable.

Page 65 of 66