1.The electronic and pneumatic units of the SLE5000 infant ventilator are sealed at the
factory with two “Warranty Void If Label Broken” seals. If the ventilator is subject to a
warranty agreement do not attempt to carry out any procedure that would involve
breaking these seals. If you make a warranty claim and these seals are broken SLE
may deem the warranty claim null and void. If the ventilator develops a fault within the
warranty period please refer to your warranty documentation.
2.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.
3.Check the condition of the gas supply hoses to the ventilator. Do not use any hose that
shows signs of cracking, abrasion, kinking, splits, excessive wear or ageing. Make sure
that the Air or O2 hose has not come into contact with oil or grease.
4.The SLE5000 ventilator contains temperature dependant devices which perform
normally in controlled environments in hospitals. However if the ventilator has been
stored at a temperature different to that in which it will be used, allow the unit to
acclimatize before powering up.
5.Failure to comply with the recommended service programs could lead to injury of the
patient, operator or damage to the ventilator. It is the owners responsibility to ensure
that the equipment is regularly maintained.
6.The SLE5000 contains static sensitive electrical devices. Anti static precautions must be
observed at all time when working on the ventilator.
7.When working on the ventilator disconnect the mains supply. Use an earthing strap to
earth the ventilator.
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Page 11
1.2 Cautions
1.When working on the pneumatic unit, protect the front facia panel by resting it on a soft
pad.
2.Do not use a sharp instrument, such as a pen to activate the controls as the excessive
pressure applied by the point will damage the touch screen membrane.
3.The Ventilator must be connected to a suitably rated and grounded electrical power
source.
4.If the SLE5000 is adversely affected by equipment emitting electromagnetic interference
then that equipment should be switched off or removed from the vicinity of the SLE5000.
Conversely, if the SLE5000 is the source of interference to other neighbouring
equipment, it should be switched off or taken to another location.
5.The functioning of this machine may be adversely affected by the operation of
equipment such as high frequency surgical (diathermy) equipment, defibrillators, mobile
phones or short-wave therapy equipment in the vicinity.
8.The equipment is not suitable for use with, or in the presence of flammable anaesthetic
mixtures.
6.The SLE5000 flow monitoring system is calibrated to work in an air / oxygen mixture, the
use of other gas mixtures may affect the flow monitoring accuracy of the ventilator.
7.Disposal of the Oxygen Sensor should be in accordance with local regulations for
hazardous substances. Do not incinerate. SLE offer a cell disposal service.
8.The ventilator must have its batteries charged every 14 days. The ventilator must be
connected to a mains power source for 24 hours to ensure a full charge. Failure to
charge the batteries will shorten the service life of the batteries which will result in
reduced battery life in a mains power fail situation.
9.If the ventilator is operating on battery power and allowed to completely discharge the
battery, it should be recharged a soon as possible. This is to avoid damaging the
batteries by allowing them to remain in a deep discharged state for any period of time.
Allowing the batteries to remain in the deep discharged state will shorten the life of the
batteries and the amount of time the ventilator can remain on battery power.
10. If the ventilator is not going to be used for a period in excess of 40 days then disconnect
the batteries from the power supply. (See “Extended storage” on page 71.)
(Model J) Page 11
Page 12
11. The SLE5000 contains several batteries, three 2 cell sealed lead acid batteries and 2
AA alkaline batteries. At the end of their useful life these batteries should be disposed of
in accordance with local authority guidelines.
12. Apart from the batteries, the ventilator and accessories do not contain any hazardous
components therefore no special precautions are required for their disposal. The
ventilator should be disposed of in accordance to the local WEEE (Waste Electrical and
Electronic Equipment) guidelines.
13. Care should be taken when attaching other equipment as this may affect mechanical
stability.
14. Any computer connected to the ventilator must be specified for medical use .
15. There is no special protection provided against ingress of water or liquids.
16. Do not use solvent based cleaning solutions to clean the touch screen or covers.
Page 12 (Model J)
Page 13
Principles of Operation
(Model J) Page 13
Page 14
2. Principles of Operation
The SLE5000 infant ventilator consists of an electronic system in the upper section of the
ventilator and a pneumatic system in the lower.
2.1 Electronic System
The electronic system comprises three autonomous subsystems, one responsible for
monitoring the patient, one responsible for controlling the valves of the pneumatic system
and one for the user interface (touchscreen and displayed data). They are connected
together by three serial communication links in a delta configuration.
The ventilator has an internal battery that can power the ventilator in the event of a mains
power fail. If the mains power fails with the battery fully charged, then operation will continue
for 30 to 60 minutes depending on ventilation mode.
See “Electrical Block Diagram” on page 220.
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Page 15
2.2 Pneumatic System
The pneumatic system comprises of the tubing and electro-mechanical valves necessary to
provide the gas in conventional and oscillatory ventilation modes. The two gas controlling
functions are blending and pressure generation
2.2.1 Blending
The method used for blending air and oxygen in known proportions is to pressure regulate
the two supplies (air and oxygen) so they produce equal flow rates and then allow each
supply into a mixing chamber for a time period equivalent to the proportions required. For
example, delivering oxygen at a set flow rate into a mixing chamber for 1 second and air at
the same flow rate for 2 seconds will result in a mixture of 1 part oxygen to 2 parts air
(resulting in a mix of 47.3%).
2.2.2 Pressure Generation
There are three nozzles within the exhalation block in the pneumatic subsystem. One for
generating negative pressure in the patient circuit and the other two for generating positive
pressure. The pressures generated from the three nozzles are controlled by three
electronically controlled pressure regulators. The negative and one of the positive nozzle
pressures can also be switched on and off rapidly with in-line (high speed) solenoid valves.
The other positive nozzle (the mean jet) is used to generate steady pressures in ventilation
(CPAP or PEEP pressures in conventional modes and mean pressures in HFO modes).
These three nozzles (or jets) are used in various combinations to generate all ventilation
modes.
2.2.3 Conventional ventilation
In non HFO modes the negative (or reverse) jet is used in a steady mode to provide a small
amount of flow to offset the inadvertent patient circuit pressure generated from the fresh gas
flow of 8 lpm. The mean jet is also used in a steady mode to generate the base pressure
level (CPAP or PEEP) and the forward jet is used to generate the PIP pressure during the
inspiratory phase. The rise time of the inspiratory phase is controlled by dynamically
controlling the forward jet pressure regulator rather than switching a steady pressure with
the high speed valves.
This provides a smooth rise in pressure and allows user adjustable rise times rather than
abrupt changes and pressure “ringing” which can result from high speed switching. The fall
of the inspiratory wave is also controlled by the forward jet pressure regulator to bring the
pressure down quickly and smoothly, using the high speed valves to do this would again
result in inadvertent ‘ringing’ which causes difficulties for the monitor subsystem in trying to
detect a patient breath attempt by monitoring the pressure alone. Once the pressure has
been brought close to the base pressure, after about 100 ms, the forward jet solenoid is
switched off to prevent any further artefact causing false triggering.
(Model J) Page 15
Page 16
Note that all jet pressures actually sum in the exhalation block, for example, to ventilate a
patient with a PEEP pressure of 5 mbar and a PIP pressure of 30 mbar, the mean jet will be
set to generate a continuous circuit pressure of 5 mbar and the forward jet will be set to
generate a circuit pressure varying between zero (exp phase) and 25 mbar (insp. phase).
Since the jet pressures will sum, this will result in the desired patient pressure.
2.2.4 HFO ventilation
In pure HFO mode the mean jet pressure regulator is used purely to set the mean pressure.
The forward and reverse jet pressure regulators are used to generate steady positive and
negative delta P components that will be superimposed on the mean pressure. These
components are switched quickly using the high-speed solenoid valves to generate the HFO
pressures.
For example to ventilate a patient with a mean pressure of 10 mbar and a delta P pressure
of 60 mbar, the mean jet will be set to generate a continuous pressure of 10 mbar, the
forward jet will be set to generate a continuous pressure of 30 mbar and the reverse jet will
be generating a continuous pressure of –30 mbar. The HFO rate is determined by the rate of
switching between the forward and reverse pressures on the high-speed valves. Again,
because the jet pressures sum, the resulting patient pressures will be switching between –
20 mbar and +40 mbar.
Mean HFO pressures up to 35mbar are required but the mean jet can only generate
pressures up to about 20 mbars. To obtain higher mean pressures than 20mbars in HFO it is
necessary to apply a higher pressure on the forward pressure regulator and a lower
pressure on the reverse pressure regulator. Using this method, the desired mean must be
less than half the desired delta p pressure plus 20 mbars.
See “Pneumatic Unit Schematic” on page 222.
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Page 17
Description of Symbols
(Model J) Page 17
Page 18
3. Description of Symbols
SymbolDescription
Type BF connection (Situated on front panel)
Read manual (Situated on rear panel)
Date of Manufacture (Appears on serial number label)
Do not dispose of as general waste (WEEE directive)
(Appears on serial number label)
EEC conformity marking showing compliance with the Medical
Devices Directive (Appears on serial number label)
Indicates the mains power switch
Mains power present, (Situated on front panel)
Indicates a warning in the manual
Observe anti static precautions
Page 18 (Model J)
Page 19
SymbolDescription
Indicates a note in the manual
Indicates a caution in the manual
Check list item.
(Model J) Page 19
Page 20
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Page 21
Equipment List
(Model J) Page 21
Page 22
4. Equipment list
To service the SLE5000 infant ventilator the service personnel will require the following
equipment. Items marked with an SLE part number can be obtained by contacting the
service department.
• Electronic engineers tool kit.
a/b
•
•a Patient circuit....................................................SLE Part Nº: BC5188/100 or /400
•a Humidification chamber (Typically MR225)......SLE Part Nº: N3220
•
•
•
•
Calibration analyser (calibrated in mbar) .......SLE Part Nº: N2830
b
Test lung...........................................................SLE Part Nº: N6647
c
Foam support pad
a
Digital Multimeter (1mv resolution)
a
Calibration kit....................................................SLE Part Nº: N9025
Which contains the following:
Block and leak Y piece assembly Qty 1
Flow tubing assembly ................ Qty 1
Internal pressure tubing kit ........ Qty 1
Y piece Kit .................................. Qty 1
Dummy load kit .......................... Qty 1
Tygon tubing 3/8" x 9/16" ...........Qty 600mm
•cStatic protection wrist band
•cAnti-static protective bags (300mm x 300mm)
•a Flow sensor cable.............................................SLE Part Nº: N6635
•a Flow sensor......................................................SLE Part Nº: N5201
a
Exhalation block ...............................................SLE Part Nº: N6622
•
•a Oxygen supply
•a Air supply
a
•
Earthing strap
a
Note all items marked with an ‘a’ are required for servicing and overhaul. Without these
items the user will be unable to service or overhaul the SLE5000 ventilator.
b
Note items marked with a ‘b’ are required to carry out the functional testing routine.
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Page 23
Engineering Mode Software
(Model J) Page 23
Page 24
5. ENGMODE
The SLE5000 ventilator is calibrated via two calibration programs, one for the
ventilator and one for the Touch screen. The calibration programs are accessed
via the Controller Services panel in the user interface.
5.1 Accessing the Calibration Programs
Step 1 Press the Options and Service Data
Button.
Step 2 Press the Next button.
Step 3 Press the Version button.
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Page 25
Step 4 Press the Controller button.
Step 5 Enter the code supplied by SLE into the
ventilator, via the controller services panel
to activate the calibration program.
Begin psv is the A button.
End psv is the B button.
Apnea supis the C button.
Enter your code here____________________
(Model J) Page 25
Page 26
5.2 Ventilator Calibration Program
The calibration program has four main functions.
1. Sensor Calibration
2. Jet Calibration
3. O2 & Flow System Calibration
4. Elapsed Time Reset.
5. Language Selection
6. Exit
5.2.1 Sensor Calibration
The sensor calibration panel allows the following sensors to be calibrated.
Controller
The setting of the
block and leak sensor
offset and gain.
The setting of the
blender sensor offset
and gain.
Monitor
The setting of the
blender sensor gain.
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Page 27
5.2.2 Jet Calibration
The jet calibration panel allows the forward jet, reverse jet and mean jet to be
adjusted. Also contained within this panel are the controls to adjust the inspiratory
and expiratory leading edges of the CMV wave form. Associated controls to set
the ventilator in CMV or HFO mode are also displayed.
Note: HFO mean compensation is automatically set to OFF in ENGMODE.
5.3 O2 & Flow System Calibration
The O2 & Flow System calibration panel allows the calibration of the oxygen
monitoring system (2 point calibration, 100% and 21%) and the calibration of the
flow system.
The flow system is a
factory set system
and requires an ETU2 for calibration.
Note: O2 calibration
time is 7 minutes.
(Model J) Page 27
Page 28
5.4 Reset Elapsed Time
The reset elapsed time panel allows the ventilators time counter to be reset to
zero days and minutes.
This function is only
used at the 20,000
hour overhaul.
5.5 Language Selection
The “Language Selection Program” panel displays the languages choices that
can be installed.
Note: For version 4.3.1 software the “Language Selection Program”
can be accessed from the user interface see section 5.6 on page 29.
Page 28 (Model J)
Page 29
The Select Language area
of the screen will display a
number of buttons. The
number of buttons will vary
according to the release of
foreign languages.*.
* Please contact SLE or your distributor for information on the availability of
secondary languages.
To install a secondary language select the language required.
The name of the selected
language will be displayed
in the selected language
area.
Press the “Install Language” button. When the name of the installed language is
displayed in the Installed Language area the installation is complete.
Press “Exit” and restart the ventilator.
5.6 Activation of Language Selection Program form User Interface
Enter the following code AABBCC into the ventilator
via the controller services panel to activate the
Language Selection Program.
Begin psv is the A button.
End psv is the B button.
Apnea supis the C button.
5.7 Exit
The exit button will return the user to a DOS prompt. To return to the ventilator to
its normal operating mode, restart the ventilator.
(Model J) Page 29
Page 30
5.8 Touch Screen Calibration Program
The touch screen calibration program is accessed by the same method as for the
calibration program. See ’5.1 Accessing the Calibration Programs’ on page 24.
Enter you code here____________________
For the touch screen please follow the on screen instructions.
To return to the ventilator to its normal operating mode, restart the ventilator.
Warning: Failure to carry out the touch screen calibration correctly can
cause the ventilator to become unusable. A failed touch screen calibration
can only be corrected by connection of a specialist device. Please contact
SLE or your distributor in this situation.
Page 30 (Model J)
Page 31
Component Replacement
(Model J) Page 31
Page 32
6. Component Replacement Procedure
The component replacement procedures detailed in this chapter describes how to replace
the individual component in isolation. Each procedure details what setup is required to return
the ventilator to service. After completing any or all of the following procedures a full
functional test as described in this manual must be carried out.
The following replacement and setup procedures are detailed in this chapter.
Electronic unit
• Compact flash card...................................SLE Part Nº: N6631/21/CF/50
• PC board ..................................................SLE Part Nº: N6631/LX800
• CAN card ..................................................SLE Part Nº: N6634
• Computer /display control assembly.........SLE Part Nº: L0275/OEM2
• Serial controller (Touch screen)................SLE Part Nº: N6631/2216
• Control and monitor board........................ SLE Part Nº: A0763/02/M
• Power supply unit......................................SLE Part Nº: M0915
• Batteries....................................................SLE Part Nº: M0901
• Transducer PCB assembly....................... SLE Part Nº: A0761
• LCD...........................................................SLE Part Nº: N6631/02
• Touch screen.............................................SLE Part Nº: N6631/05
• Inverter PCB .............................................SLE Part Nº: N6631/13
•
Pneumatic Unit
• Conical and Duckbill filters........................SLE Part Nº: N2185/06 & N2185/05
• Blender manifold block..............................SLE Part Nº: N0280/01
• Pressure regulators PR3, PR4 & PR6......SLE Part Nº: N0280/02/S46
• High speed jet valves SV9, 10, 11 & 12....SLE Part Nº: N0280/03
• Regulator input air PR1.............................SLE Part Nº: N0280/05
• Regulator input oxygen PR2.....................SLE Part Nº: N0280/06
•
Page 32 (Model J)
Page 33
7. Preparing the SLE5000
A
A
A
A
A
Caution: the SLE5000 ventilator weighs 21.8kg fully assembled. Care should
be taken when handling the ventilator.
If preparing to work on both the electronic and pneumatic units of the SLE5000 remove the
ventilator from the stand and place it on a flat stable surface. The SLE5000 ventilator is
attached to the trolley or pole by two screws with shake proof washers. Retain the screws
and washers for re-attachment of the ventilator.
If work is to be carried out on the electronic unit only, it is advisable to leave the ventilator
attached to the trolley.
Step 1 Remove the five fixing screws (A) from
the rear cover.
Step 2 Slide the rear cover towards the rear of
the machine. When the lip has been disengaged
lift the cover off.
(Model J) Page 33
Page 34
Warning: If the ventilator is under a
C
C
D
D
B
D
warranty agreement removal of the
inner covers may void the
agreement. Please refer to the
warranty documentation.
Step 3 Remove the screws (B) (2
screws) (C) (4 screws) to release the
electronic inner cover.
Step 4 Remove the screws (D) (6
screws) to release the pneumatic unit
base plate.
Step 5 Rest the ventilator on a soft
pad.
Warning: Disconnect the ventilator
from the mains supply. Use an
earthing strap to earth the ventilator.
Page 34 (Model J)
Page 35
8. Component Replacement (Electronic unit)
B
B
B
B
B
C
C
C
D
G
G
E
F
A
H
I
I
I
8.1 N6631/21/CF/50 Compact Flash Card
1. Slide the compact flash card (B) out of its socket
in the direction of the arrow.
2. Insertion of the compact flash card is the reverse
of removal.
Caution: Do not force the compact flash card out of the carrier , as it may catch
on the connector mounted on the edge of the board
Setup: If the same or new card is inserted software then a full functional test is required for
this component. If the card is part of full software upgrade i.e. with control and monitor
firmware, then a full system calibration is required.
8.2 N6631/LX800 PC Board
1. Disconnect the display cable (A).
2. Remove the screws (B) and washers (C)
that retain the PC board to the support pillars.
3. Disconnect the inverter enable cable (D)
and the PC board power connector (E).
4. Gently disconnect the PC board (F) from
the CAN card by lifting the board vertically,
until all the connector pins are disengaged
from the socket.
5. Disconnect the interface cables (G) from the
PC board.
6. Disconnect the serial controller cable (H)
from the PC board.
7. The PCB spacers (I) are now loose.
8. Assembly is the reverse of removal.
Setup: Confirm that the ventilators time and date settings are correct. (Refer to the user
manual for more details on how to set the time and date).
(Model J) Page 35
Page 36
8.3 N6634/OEM2 CAN Card
A
B
B
A
B
C
D
C
Warning: The CAN card is a static sensitive device.
1.The CAN card (A) is already loose from the
removal of the N6331/LX800 PC board.
2. Disconnect the CAN card ribbon cables (B).
3. The CAN card (A) can now be removed.
4. Assembly is the reverse of removal.
Setup: No setup is required for this device.
8.4 N6631/2216 Serial controller (Touch screen)
Warning: The Serial controller is a static sensitive device.
1. Disconnect the touch screen ribbon cable
(A) from the board.
2. Disconnect the carrier board link cable (B)
from the board.
3. Remove the two nuts and washers (C)
retaining the serial controller PCB.
4. Remove the serial controller PCB (D).
5. Assembly of the serial controller PCB is the
reverse of removal.
Setup: Touch screen calibration.
Page 36 (Model J)
Page 37
8.5 L0275/OEM2 Computer/Display Control assembly
A
B
E
C
F
G
D
Red/Black wire
Pin 1
L0275/OEM2
Warning: The Computer/Display Control assembly is a static sensitive device.
1. Remove the PCB locking screw. This will allow the top board assembly
to slide forward a small amount which gives better access to the edge
connectors of the top board.
2. Disconnect the display cable connector (A).
3. Disconnect the touch screen connector cable connector (B).
4. Disconnect the carrier board power cable connector (C).
5. Disconnect the inverter board power cable connector (D).
6. Disconnect the CAN card interface cables (E & F).
7. Disconnect the RS232 connector cable (G)
8. The carrier board can now be removed by sliding towards the rear of the ventilator.
Note: The orientation of the
display cable .
(Model J) Page 37
Page 38
8.6 A0763/02/M Control/Monitor Board
E
F
H
I
J
K
B
C
A
D
G
L
Warning: The Control/Monitor Board is a static sensitive device.
1. Remove the L0275/OEM2
Computer/Display Control
assembly as described in section
8.5.
2. Disconnect the following cables.
3. CAN card link ribbon cable
controller side (A). (P3)
4.CAN card link ribbon cable
controller side (B). (JP3)
5. Power supply connector
controller side, main loom (C). (P4)
6. Controller to A0761 transducer
assembly ribbon cable (D). (P5)
2. Disconnect the electrical connectors
from PR3 (D), PR4 (E) and PR6 (F).
PR3 cable is tagged 3.
PR4 cable is tagged 4.
PR6 cable is tagged 6.
Page 48 (Model J)
Page 49
3.Remove the four nuts and washers (G)
G
G
G
G
K
J
M
I
H
L
L
securing the pressure regulator manifold
assembly.
4. To remove the pressure
regulators (H, I & J) from
the manifold block (K)
remove the screws (L),
two per regulator.
5. Assembly is reversal of removal.
Setup: Full system calibration is required for this component.
(Model J) Page 49
Note: that the ‘O’ rings (M) will be released once the regulator has been
removed.
Page 50
9.1.3 N0280/03 High Speed Jet Valve Assembly
B
C
A
D
D
D
D
Location in pneumatic unit
Part number: N0280/03
1. Disconnect the electrical connectors
from PR3 (A), PR4 (B) and PR6 (C).
PR3 cable is tagged 3.
PR4 cable is tagged 4.
PR6 cable is tagged 6.
2. Loosen but do not remove the four nuts
(D) securing the pressure regulator
manifold assembly. Once loose slide the
assembly in the direction of the arrow.
Page 50 (Model J)
Page 51
3. The high speed valve assembly and
E
F
loom (E) can now be removed by
disengaging the valves from the rear of
the forward and reverse jet manifold
(F).
4. Assembly is reversal of removal.
Setup: Pneumatic setup and full system calibration is required for this component.
(Model J) Page 51
Page 52
9.1.4 N0280/05 inlet air pressure regulator
B
C
A
C
B
1.Remove the remaining tube (A) from the
inlet air pressure regulator (B).
2. Remove the two nuts (C).
3. Withdraw the regulator (B).
4. Assembly is reversal of removal.
Setup: Full system calibration is required
for this component.
Page 52 (Model J)
Page 53
9.1.5 N0280/06 inlet oxygen pressure regulator
B
C
A
D
E
G
F
I
E
E
H
A
C
J
C
K
A
1. Disconnect the tube (A) from the inlet
manifold elbow (B).
2. Disconnect the tube (C) from the inlet
manifold elbow (D).
3. Remove the two fixing nuts (E).
4. Draw the regulator (F) from the exhaust
block (G) disengaging the tube (H) from
the fitting (I).
Note: the tubes (A & C) will be
discarded with the regulator.
5. Assembly is reversal of removal for the
original component.
5. For a new regulator connect new bleed
tubes (A & C) to the replacement oxygen
regulator bleed ports (J & K).
Tube length A = 210mm
Tube length C = 190mm
Note: Panel mount regulator shown.
Setup: Full system calibration is required
for this component.
(Model J) Page 53
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Page 55
A0763/02/M Board
(Model J) Page 55
Page 56
10. A0763/02/M Monitor and control board
A
B
d
c
1
5
6
4
3
2
e
The SLE5000 uses the base A0760 Rev F PCB to make up the A0763/02/M
board.
10.1 A0763/02/M board programmable devices
The A0763/02/M board is divided into two sections a) the monitor side and b) the
control side.The monitor section is divided into a further two sections c) monitor
isolated and d) monitor non islolated.
On the A0763/02/M board there are six programmable devices. These devices
are:
1) U23 monitor software non isolated IC
2) U25 monitor non isolated PAL
3) U9 monitor software isolated IC
4) U14 monitor isolated PAL
Page 56 (Model J)
5) U33 controller software IC
6) U34 controller PAL
Page 57
10.2 A0763/02/M Board Hardware Identifier
The A0763/02/M board has a group of resistors that allow the software to
recognize the pneumatic unit configuration. There are 10 hardware idents
possible on the board.
The table below outlines the resistor groups to produce specific hardware ID’s.
The SLE5000 Model G ventilator uses Hardware Ident 3.
(Model J) Page 57
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Page 58 (Model J)
Page 59
Electrical Safety Testing
(Model J) Page 59
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Page 61
11. Electrical Safety Testing of the SLE5000
This test is performed using an approved electrical safety testing device.
The electrical safety test must be carried out on the unit with all the electrical connections
intact.
Connect the ventilator to the electrical safety tester and turn the unit ON.
Connect the flow sensor connector via a test loom to the electrical safety tester.
Perform the tests.
Equipment under test is: SLE5000 Infant Ventilator Class 1B (flow sensor is a Floating type
applied part).
TestExpected Results
Class B Tests
Expected ValueTolerance
Insulation Resistance
Earth Continuity
Earth Leakage
Earth Leakage (supply o/c)
Enclosure Leakage (normal)
Enclosure Leakage (earth o/c)
Enclosure Leakage (supply o/c)
Patient Leakage on Applied Part
Patient Leakage on Applied Part (Earth o/c)
Patient Leakage on Applied Part (supply o/c)
Class BF Tests
Mains on Applied Part Normal
Mains on Applied Part Reversed
Check that in all the preceding tests: the resistance to earth on the internal metal screening
is less than 0.2Ω.
This check should only be carried out if the PSU is suspected to be faulty.
a) Unplug the battery connector from the PSU.
b) Remove the the top board assembly.
c) Turn on the ventilator and check the output voltages of the power supply at the
following points on the wireloom.
On P4 (connection to the controller
side of the controller monitor board)
check the following pins.;
d) Turn off the ventilator and reconnect the battery connector.
e) Refit the PC board
f) Turn on the ventilator and check that the cooling fan is rotating and the power
LED on the front panel is illuminated.
g) On the battery connection, check that the voltage indicates battery charging.
Look for the voltage increasing gradually as the battery charges. 13.8V = o/c
condition or battery fully charged.
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Power Up-Down & Battery Care
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13. Ventilator Power up and Power down.
2 seconds
13.0.1 Mains power indicator.
The ventilator has a LED indicator on the front facia to indicate when mains
power is present. The indicator unlike previous models does not indicate that the
machine is ON. The mains power present indicator allows the user to see that the
ventilator is charging the batteries.
13.0.2 Powering up and down.
The ventilator has an internal battery that will allow the ventilator to continue
operating in a mains power failure situation. The ventilator can also be started on
battery power when not connected to the mains or in a mains power fail situation.
The user has to be aware that the “Mains Power Fail Alarm” will sound until mains
power has been restored.
13.0.3 Turning ON the ventilator
Depress and hold down the mains power switch for 2 seconds. When the
ventilator has started release the button.
13.0.4 Turning OFF the ventilator
Depress and hold down the mains power switch for 2 seconds. The ventilator will
power down but the “Complete Power Fail Alarm” will be active.
To cancel the alarm depress the mains switch again but do not hold down.
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14. Back-up Battery Charging
A
B
Prior to first use, the ventilator should be connected to a suitable power outlet that
is ON for a minimum of 24 hours. The ventilator does not need to be turned on to
charge the battery.
The ventilator will indicate that mains power is present via the indicator LED on
the front of the machine.
It is recommended that the ventilator has its batteries charged every 14 days. The
ventilator must be connected to a mains power source for 24 hours to ensure a
full charge.
If the ventilator has not been used or charged in a 40 day period, it must be
charged for 24 hours. Failure to do this will leave the batteries in a deep
discharged state.
Warning: Allowing the batteries to remain in the deep discharged state will
shorten the service life of the batteries and the amount of time the ventilator
can remain on battery power.
Warning: If the ventilator is operating on battery power and allowed to
completely discharge the battery, it should be recharged a soon as
possible.
14.1 Battery indicator
Version 4.3 software displays two icons in the top left hand corner of the screen.
The first is the battery status icon (A) and the second is the mains power
connected icon (B). The battery status icon operates in two different ways,
dependant on model of ventilator. The mains power connected icon functions the
same way on all models of ventilator.
When mains power is connected, the ventilator displays the mains power
connected icon.
When mains power is disconnected, the ventilator displays the mains
power disconnected icon.
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The battery status icon has seven states.
With mains power connected or disconnected
a) Charged to 75% or greater, the battery icon displays three green blocks.
With mains power disconnected
b) Discharged to between 50% and 75% of battery capacity.
c) Discharged to between 25% and 50% of battery capacity.
d) Discharged to between 0% and 25% of battery capacity
With mains power connected
e) Charging, where the blocks cycle from left to right.
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15. Extended storage
A
A
A
A
A
D
E
If the ventilator is not going to be used for a period in excess of 40 days then the
following protocol has to be followed.
The batteries will require charging prior to disconnection for 24 hours. This is
required to protect the batteries against damage due to deep discharge.
1. Remove the five fixing screws (A)
from the rear cover.
2. Slide the rear cover to reveal the battery fuse holder.
3. Pull out the fuse drawer (D).
4. Remove the fuse from the rear
compartment and place it in the front
compartment (E).
5. Close the fuse drawer (D).
6. Tag the ventilator to record that the
batteries have been disconnected.
On re-commissioning the ventilator reverse the above process and re-charge the
batteries for a further 24 hours.
Note: If the ventilator has been in storage for more than 18 months then
carry out a 10,000 hour overhaul prior to returning the ventilator to service.
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Maintenance and Overhaul
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16. Maintenance and Overhaul
The ventilator has the following maintenance / overhaul schedule.
12 monthsPreventative maintenance Kit: N9010/12/G
24 months (10,000hrs) OverhaulKit: N9010/24/G
36 monthsPreventative maintenanceKit: N9010/12/G
48 months (20,000hrs) OverhaulKit: N9010/48/G
4. Discard the O-ring’s, nylon filter cones, washers and duckbill check valves.
5. Re-assemble with the new components.
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16.2.3 Replacement of N2042 “O” Rings
A
B
1. Remove the silencer and exhalation
block from the ventilator.
2. Locate the two ’O’ rings located (A & B)
on gas ports.
3. Using a blunt probe lift out the old ’O’
ring and discard. Repeat the process for
the other ’O’ ring.
4. Wipe the gas ports with an approved
sterilizing solution.
5. Place new ’O’ rings into the grooves.
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16.2.4 Replacement of N2191/10 O2 Cell
A
B
B
1. Remove the O2 cell cover plate (A).
2. Pull out the cable until the connector (B) is
visible. Gently pull apart the connector.
3. Unscrew the cell anti-clockwise until free and
discard, treat the cell as a battery and dispose of
in the appropriate method.
4. Replacement of the cell is the reversal of
removal.
5. In addition to the tests carried out in the
previous preventative maintenace procedure,
carry out a 2 point oxygen calibration routine.
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16.2.5 Replacement of CMOS backup batteries
1. Remove the two AA batteries and discard in accordance with local waste authority
guidelines.
2. Replace the batteries taking care to correctly insert the cells.
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24 & 48 Month Overhaul
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16.3 24 month and 48 month overhaul procedures
The ventilator has two overhaul points, the first at 24 months or 10,000 hours (whichever is
sooner) and 48 months or 20,000 hours (whichever is sooner).
The 24 month / 10,000 hour overhaul consists of the replacement of the following
components.
These components are supplied in the form of an overhaul kit part Nº: N9010/24/G
Options available for the 48 month overhaul:
Option 1. To carry out a service exchange of the pneumatic unit. (Part Nº: N9010/200)
Option 2. To purchase a new pneumatic unit. (Part Nº: N9010/250)
Option 3. To carry out the overhaul from the N9010/48/G kit of parts.
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24 Month / 10,000 Hour Overhaul
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16.4 24 month / 10,000 hour overhaul procedure
A
A
A
A
A
The following instructions, list the order in which the 24 month overhaul should be carried
out.
1. Remove the five fixing screws (A)
indicated from the rear cover.
2. Slide the rear cover towards the rear of
the machine. When the lip has been
disengaged lift the cover off.
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Warning: If the ventilator is under a
C
C
D
D
B
D
warranty agreement removal of the
inner covers may void the agreement.
Please refer to the warranty
documentation.
3. Remove the screws (B) (2 screws)
(C) (4 screws) to release the electronic
inner cover .
4. Remove the screws (D) (6 screws) to
release the pneumatic unit base plate.
5. Rest the ventilator on a soft pad.
Warning: Disconnect the ventilator
from the mains supply. Use an
earthing strap to earth the ventilator.
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16.4.1 L0275/OEM2 Computer/Display Control assembly
A
B
E
C
F
G
D
Red/Black wire
Pin 1
L0275/OEM2
Warning: The Computer/Display Control assemblies are static sensitive
devices.
1. Remove the PCB locking screw. This will allow the top board assembly
to slide forward a small amount which gives better access to the edge
connectors of the top board.
2. Disconnect the display cable connector (A).
3. Disconnect the touch screen connector cable connector (B).
4. Disconnect the carrier board power cable connector (C).
5. Disconnect the inverter board power cable connector (D).
6. Disconnect the CAN card interface cables (E & F).
7. Disconnect the RS232 connector cable (G).
8. The carrier board can now be removed by sliding towards the rear of the ventilator.
Note: The orientation of the
display cable .
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16.4.2 A0763/02/M Control/Monitor Board
E
F
H
I
J
K
B
C
A
D
G
L
Warning: The Control/Monitor Board is a static sensitive device.
1. Disconnect the following cables.
3. CAN card link ribbon cable
controller side (A). (P3)
4.CAN card link ribbon cable
controller side (B). (JP3)
5. Power supply connector
controller side, main loom (C). (P4)
6. Controller to A0761 transducer
assembly ribbon cable (D). (P5)
10. Battery/power supply sensing connector, main loom (H). (JP9)
11. Controller to A0761 transducer assembly connector (I). (JP7)
12. O2 cell connector (J). (JP8)
13. Power supply connector monitor side, main loom (K). (JP6)
14. Flow sensor connector (L). (JP4)
15. The control and monitor board can
now be removed.
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16.4.3 Removal of the Backup Batteries
A
A
B
1. Disconnect all the battery
terminal leads.
2. Remove the four retaining
screws for the first two battery
blocks.
3. Remove the two batteries.
4. Remove the two fixing screws and washers (A),
securing the fixing bracket (B) for the third battery.
5. Slide the battery forward and lift clear.
6. Remove the two fixing screws to release the
bracket from the battery block.
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7. Remove the two screws retaining the bracket to
the battery.
8. Reversing the procedure for replacement of the batteries, re-install all the electronic
module components.
Note: When refitting the batteries the screws require a torque setting of 1.2Nm
9. Carry out the following to complete the 24 month overhaul.
10. Carry out the 12 & 36 month preventative maintenance procedure.
16.4.4 Setup
1. Reset the time and date.
2. Carry out the two point oxygen calibration.
3. Carry out a full functional test.
4. Replace all the covers.
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48 Month / 20,000 Hour Overhaul
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16.5 48 month / 20,000 hour overhaul procedure
A
B
C
D
E
F
F
F
F
F
F
F
The procedure for the 48 month / 20,000 overhaul is as follows for Options 1 and 2.
1. Remove the outer cover, inner cover and base
plate
2. Remove the front facia panel by removing the
attaching countersunk screws.
Note: The front facia panel cannot be
removed completely as it remains connected
via two electrical cables to the electronic unit.
3. Disconnect the following tubes connected to ports (A & B).
Note: Tubing removed for clarity.
4. Disconnect the three looms (C, D & E) from the bulkhead connectors.
5. Remove the seven fixing screws and washers (F).
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6. Attach the new pneumatic unit (reverse of removal).
Note: The service exchange or the new pneumatic unit will be Model M-1 in design.
Please refer to the Model M & M-1 service manual available from the SLE service
department.
7. Refit the front facia panel.
8. Carry out the replacement procedure for the following items, CPU battery and backup
batteries.
9. Replace inner and outer covers.
10. Carry out a full system calibration, followed by a complete functional tests.
11. After calibration and functional testing, carry out a full electrical safety test.
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16.6 48 month overhaul procedure using N9410/48/G overhaul kit.
B
C
A
E
F
D
The overhaul of the electronic unit follows the same procedure as that of a 24 month
overhaul.
16.6.1 Pneumatic unit 48 month overhaul procedure
Note: Replace any tubing deemed to be brittle, damaged or discoloured. Tubing
should be removed and replaced as the item it is attached to is removed from the
pneumatic unit.
16.6.2 Removal of N0280/03 High Speed Jet Valve Assembly