SLE SLE2000 HFO Manuel utilisateur

SLE2000

Service manual

Page 2 (SLE2000)

Contact Information:

in any form or by any means, electronic, mechanical, photocopy, recording or otherwise, without prior

permission of SLE. © Copyright SLE 19/03/2012.

Manual : SM7 Issue 12

SLE Part Nº: N2000/00

SLE Limited

Twin Bridges Business Park

232 Selsdon Road

South Croydon

Surrey CR2 6PL

Telephone: +44 (0)20 8681 1414

Fax: +44 (0)20 8649 8570

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

Web site: www.sle.co.uk

(SLE2000) Page 3

Contents

1. Introduction ............................................................................................................... 8

2. Principles of operation SLE2000 valveless system ................................................... 8

3. User/owner responsibility .......................................................................................... 10

4. Warnings ................................................................................................................... 11

5. Symbols used on or in the equipment ....................................................................... 12

6. Glossary of abbreviations ......................................................................................... 13

7. Ventilator control description ..................................................................................... 16

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

7.2. Function of front panel controls and indicators............................................... 17

7.3. Rear panel...................................................................................................... 19

7.4. Side panel ...................................................................................................... 20

8. Accessing the SLE2000 internal components. ......................................................... 22

8.1. Electronic module........................................................................................... 22

8.2. Pneumatic module.......................................................................................... 22

8.2.1. To Remove the A0702/01 PCB (Runner mounted) ................................. 23

8.2.2. To Remove the A0702/01 PCB (Pillar mounted) ..................................... 24

8.3. To Separate The Two Modules ...................................................................... 25

8.4. Removal Of The Oxygen Blender................................................................... 26

8.5. Removal of the Oxygen cell............................................................................ 27

8.5.1. Oxygen Cell Mounting ............................................................................. 27

9. Maintenance ............................................................................................................. 30

9.1. Cleaning, disinfection and sterilization ........................................................... 30

9.1.1. Preparation of a new ventilator ................................................................ 30

9.1.2. Cleaning and disinfection of an in-service ventilator................................ 30

9.1.3. Cleaning, Disinfection & Sterilization chart .............................................. 31

9.1.4. Cleaning method...................................................................................... 31

9.1.5. Disinfection method ................................................................................. 32

9.1.6. Sterilization method ................................................................................. 32

9.2. Filter systems ................................................................................................. 33

9.2.1. Bacterial filter, SLE Part Nº:N2029 (Autoclavable) .................................. 33

9.3. Bacterial filter, SLE Part Nº:N2587 (Single use)............................................. 33

9.3.1. Precautions when using bacterial filter N2587......................................... 33

9.4. Monthly operational checks............................................................................ 34

9.4.1. Battery condition and LED display test. ................................................... 34

9.4.2. Air and oxygen supply failure alarm test.................................................. 34

9.4.3. Condition of O2cell.................................................................................. 34

9.4.4. Proximal airway pressure gauge accuracy .............................................. 34

9.4.5. Inspiratory nozzle..................................................................................... 34

9.5. Preventative maintenance.............................................................................. 35

9.6. Overhaul......................................................................................................... 35

9.6.1. Service parts list ...................................................................................... 36

Page 4 (SLE2000)

10. Electronic module description .................................................................................38

10.1. Description of operation ................................................................................38

11. Pneumatic module description ...............................................................................40

11.1. Description of operation ................................................................................40

11.2. Fresh Gas System ........................................................................................42

11.3. CPAP System ...............................................................................................43

11.4. Inspiratory System ........................................................................................44

11.5. Pneumatic Circuit Diagram ...........................................................................45

11.6. Pneumatic Module Parts List ........................................................................46

12. Test Equipment Required ........................................................................................50

13. SLE2000 Calibration Procedure ..............................................................................51

13.1. Electronic unit preliminary checks and adjustment .......................................51

13.1.1. System Watchdog ..................................................................................52

13.1.2. Pressure Transducer, PTR1 Calibration. ...............................................52

13.1.3. Pressure Transducer Buffered Output ...................................................52

13.1.4. CPAP alarm threshold control. ...............................................................52

13.1.5. PIP alarm threshold control. ...................................................................53

13.1.6. Inspiration Time Control .........................................................................53

13.1.7. Alarm Volume Control ............................................................................53

13.1.8. Airway Trigger Calibration (Part 1) .........................................................53

13.2. Pneumatic module setup and calibration ......................................................54

13.2.1. Fresh Gas Pressure Regulator (REG3) Adjustment ..............................54

13.2.1. Minimum blender flow needle valve (NV2) adjustment .........................54

13.2.2. Fresh gas flow needle valve (NV1) adjustment......................................54

13.2.3. Fresh Gas Block and Leak Alarm...........................................................55

13.2.4. FiO2 Digital Display................................................................................55

13.2.5. Airway Trigger Calibration (Part 2) ........................................................56

13.3. Soak Test......................................................................................................57

13.4. CMV mode soak test 50 hours .....................................................................57

13.5. Functional testing (Post soak).......................................................................58

13.5.1. Perform Electrical Safety Test................................................................58

4.0.1. Basic Operation........................................................................................58

4.0.2. Mains Voltage tolerance test. ...................................................................60

4.1. SLE 2000 Electrical Troubleshooting Chart ....................................................62

4.2. SLE 2000 Pneumatic Troubleshooting Chart..................................................63

5. Technical Specification ..............................................................................................66

5.1. Conventional Ventilation .................................................................................66

5.2. Displays ..........................................................................................................66

5.3. Controls...........................................................................................................67

5.4. Alarms.............................................................................................................67

5.5. Power , Dimensions etc. .................................................................................68

6. Electronic Circuit Details ...........................................................................................70

6.1. Display Board A0700/01 .................................................................................70

6.1.1. Display Board Circuit Diagram A0700/01.................................................71

(SLE2000) Page 5

6.2. LED Board A0701/01 ..................................................................................... 73

6.2.1. LED Circuit Board Diagram CD/A0701/01............................................... 74

6.3. Ventilator CPU Board AS/A0702/01 Issue 4 ................................................. 77

6.3.1. Ventilator CPU Board CD/A0702/01 Issue 2 Sheet 1 of 3....................... 78

6.3.2. Airway Trigger Circuit Diagram CD/A0702/01 Sheet 2 of 3..................... 79

6.3.3. Window Pressure Alarm A0702/01 Sheet 3 of 3 ..................................... 80

6.4. Ventilator CPU Board AS/A0702/01 Issue 5 ................................................. 84

6.4.1. Ventilator CPU Board CD/A0702/01 Issue 6 ........................................... 85

6.5. Ventilator CPU Board AS/A0702/01 Issue 5 ................................................. 89

6.5.1. Ventilator CPU Board (Detail A) .............................................................. 90

6.5.2. Ventilator CPU Board CD/A0702/01 Issue 7 ........................................... 91

6.6. RS232/423 Option.......................................................................................... 96

6.7. PSU PCB AS/A0703/01 issue 3 ..................................................................... 99

6.7.1. Power Supply Circuit Diagram CD/A0703/01 issue 4.............................. 100

6.8. PSU PCB AS/A0703/01 issue 7 ..................................................................... 103

6.8.1. Power Supply Circuit Diagram CD/A0703/01 issue 5.............................. 104

6.9. PSU PCB AS/A0703/01 issue 8 ..................................................................... 107

6.9.1. Power Supply Circuit Diagram CD/A0703/01 issue 6.............................. 108

6.10. Back-up alarm sounder AS/A0703/03 issue 1.............................................. 111

6.10.1. Back-up alarm sounder circuit diagram CD/A0703/03 issue 1 .............. 112

6.11. A0704 P.S.U. PCB assembly ....................................................................... 114

6.12. CD/W0288 Wireloom issue 1 ....................................................................... 117

6.13. CD/W0288 Wireloom issue 3 ....................................................................... 118

6.14. Electronic Chassis Stage 1 AS/L0105 issue 8 ............................................. 120

6.15. Electronic Chassis Stage 2 AS/L0104 issue 4 ............................................. 125

6.15.1. Electronic Chassis AS/L0104 issue 4 .................................................... 126

6.16. Electronic Chassis Stage 2 AS/L0104 issue 8 ............................................. 129

6.16.1. Electronic Chassis AS/L0104 issue 8 .................................................... 130

6.17. Electronic Chassis Stage 1 AS/L0105 issue 9 ............................................. 133

6.18. Electronic Chassis Stage 2 AS/L0104 issue 9 ............................................. 138

6.18.1. Electronic Chassis AS/L0104 issue 9 .................................................... 139

7. Service Information and Technical bulletins ............................................................. 156

7.1. Service Information ........................................................................................ 157

7.1.1. SI 980301 Ventilator Alarms &INOSYS Nitric Oxide Delivery System .... 157

7.1.2. SI 980302 Ventilator oxygen cells (N2191) ............................................. 159

7.1.3. SI 990302 Possible inadvertant solenoid failure messages .................... 160

7.1.4. SI 000201 Leak Alarm Trigger Threshold................................................ 162

7.1.5. SI 020901 Cleaning, Disinfection and Sterilisation of SLE ventilators..... 164

7.1.6. SI 031101 N2183 0-4 bar pressure gauge .............................................. 165

7.1.7. SI 050301Maximum Mean & Min Pressure Selection Switch.................. 166

7.1.8. SI 050701 Activation of watchdog secondary alarm sounder in case of

primary alarm sounder failure. ............................................................................ 167

7.1.9. SI 060104 Replacement N2125 push button switches ............................ 168

7.1.10. SI 060201 New PCB mounting method ................................................. 170

7.1.11. SI 060301 O0408 key switch replacement ............................................ 171

7.1.12. SI 070301 Design and component change to the A0703/01 PSU PCB 173

Page 6 (SLE2000)

7.2. Technical Bulletins ..........................................................................................174

7.2.1. TB 990603 Removal of hour counter from electrical chassis. ..................174

7.2.2. TB 000201 New versions of control software...........................................175

7.2.3. TB 000801 Ventilator Firmware Status ....................................................176

7.2.4. TB 040301 SLE2000 CPU Boards ...........................................................179

7.2.5. TB 040401 V0226 Potentiometer .............................................................181

7.2.6. TB060901 Alarm sounder replacement at 10,000 hr overhaul.................182

6. Issue Revision Record ..............................................................................................185

7. Index ..........................................................................................................................186

(SLE2000) Page 7

Introduction

Page 8 (SLE2000)

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.

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.

(SLE2000) Page 9

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

Page 10 (SLE2000)

3. User/owner responsibility

This SLE 2000 INFANT VENTILATOR equipment and the authorised accessories for it are

designed to function as specified in the relevant instruction manual only when operated,

maintained and repaired 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 should 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 and any of its accessories or component parts should not be

modified.

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 a factory authorised service representative, or from unauthorised modification of the

equipment or accessories, or from the use of components or accessories that have either

been damaged or not authorised for use with this equipment by the factory.

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