SLE SLE2000 HFO Manual de usuario

SLE2000 HFO

User manual

Page 2

Contact Information:

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

08/11/2013.

Manual : UM8 Issue 17

SLE Part Nº: N2006/00

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

Page 3

Contents

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

1.1. intended use ................................................8

1.2. Principles of Operation SLE 2000 HFO .......8

2. User/Owner Responsibility. ........................9

3. Warnings ......................................................10

3.1. Operational Warnings ..................................10

3.2. Clinical Warnings .........................................11

3.3. Monitoring ....................................................11

3.4. Clinical considerations .................................11

4. Operation ......................................................14

4.1. Functional Tests ..........................................14

4.2. Pressure Regulators and Gauges ...............14

4.3. Automatic Power On Test............................14

4.4. Setting Alarm Limits.....................................14

4.5. CPAP Mode .................................................14

4.6. CMV Mode...................................................15

4.7. PTV Mode....................................................15

4.8. SIMV Mode ..................................................15

4.9. HFO Modes .................................................15

4.10. Alarm Test .................................................16

4.10.1. To Verify Alarms ....................................16

4.10.2. High Alarm .............................................16

4.10.3. Cycle Fail Alarm.....................................16

4.10.4. Low Alarm..............................................17

4.10.5. Leak/block Alarm ...................................17

4.10.6. Mains Failure Alarm...............................17

4.10.7. O2Blender Alarm...................................17

4.10.8. Oxygen Concentration Alarm.................17

4.11. O2Cell .......................................................17

4.11.1. Condition Of O2Cell. .............................17

5. Basic Set Up for the SLE 2000 HFO ...........18

5.1. To Use the SLE 2000 HFO in CPAP Mode .19

5.2. To Use the SLE 2000 HFO in CMV Mode ...19

5.3. Patient Trigger Modes .................................20

5.3.1. To Use SLE 2000 In PTV or SIMV Mode20

5.4. To Use the SLE 2000 HFO in the Oscillator

Mode...................................................................20

5.4.1. EXP..........................................................20

5.4.2. INSP ........................................................21

5.4.3. CONT. (combined)...................................21

5.4.4. CONT. (oscillation only)...........................21

6. Technical Information .................................24

6.1. Electronic Module Controls..........................24

6.1.1. Mode Switch (5 positions)........................24

6.1.2. System Fail LED ......................................24

6.1.3. CPAP Mode .............................................24

6.1.4. CMV Mode ...............................................24

6.1.5. PTV Mode ................................................24

6.1.6. SIMV Mode ..............................................25

6.1.7. BPM .........................................................25

6.1.8. Inspiration Time .......................................25

6.1.9. I:E Ratio ...................................................25

6.1.10. Oxygen (FlO2)........................................26

6.1.11. Pressure Display....................................26

6.1.12. Three Position Switch. ...........................26

6.1.13. Pressure Display Bargraph. ...................26

6.1.14. Pressure Wave Switch...........................26

6.1.15. Manual Breath........................................26

6.1.16. HFO Controls .........................................26

6.1.17. Time Control Switch...............................26

6.1.18. Screen Switch ........................................27

6.1.19. Freeze....................................................27

6.2. Pneumatic Module Controls.........................27

6.2.1. Proximal Airway .......................................27

6.2.2. Removable Exhalation Block ...................27

6.2.3. Fresh Gas Port.........................................27

6.2.4. Regulator and Pressure Gauges .............27

6.2.5. O2Blender (% FlO2) ................................27

7. Alarms ...........................................................28

7.1. Microprocessor ............................................28

7.2. Mains Failure Audible Alarm ........................28

7.3. Gas Supply Failure Alarm ............................28

7.4. Fresh Gas Fail Alarm (Block & Leak)...........28

7.5. HFO Fail.......................................................28

7.6. Fan Fail ........................................................28

7.7. Adjustable Alarm..........................................28

7.8. High Alarm ...................................................28

7.9. Cycle Fail Alarm...........................................28

7.10. Low Alarm ..................................................28

7.11. Delta P Alarm .............................................29

7.12. O2BLender Alarm......................................29

7.13. Oxygen Alarm ............................................29

7.14. Alarm Mute.................................................29

7.15. Alarm Volume ............................................29

7.16. Alarm Verification.......................................29

8. Auxiliary Output ...........................................29

9. Rear Panel ....................................................30

Page 4

10. Filter Systems ............................................ 31

10.1. Bacterial filter, SLE Part Nº:N2029

(Autoclavable) .................................................... 31

10.2. Bacterial filter, SLE Part Nº:N2587/000/001

(Single use) ........................................................ 31

10.2.1. Precautions when using bacterial filter

N2587/000/001................................................... 31

11. Cleaning, Disinfection and Sterilization .. 32

11.1. Preparation of a new ventilator.................. 32

11.2. Cleaning and disinfection of an

in-service ventilator ............................................ 32

11.2.1. Cleaning, Disinfection & Sterilization

chart ................................................................... 32

11.3. Cleaning method ....................................... 33

11.4. Disinfection method................................... 33

11.5. Sterilization method................................... 33

12. SLE 2000 HFO Trouble Shooting Chart ... 34

13. User Operational Checks .......................... 37

14. Service and Maintenance Programmes .. 37

14.1. Maintenance.............................................. 37

14.2. Overhaul at 10,000 hours.......................... 37

14.3. 10,000 Hrs Overhaul ................................. 38

15. Glossary of Abbreviations Used in This

Manual .............................................................. 39

16. Symbols ....................................................... 40

17. Pressure Unit Conversion Constants ...... 41

18. Technical Specification ............................ 42

18.1. Conventional Ventilation............................ 42

18.2. HFO Ventilation ......................................... 42

18.2.1. Spontaneous breathing during power

failure.................................................................. 42

18.3. Displays..................................................... 42

18.4. Controls ..................................................... 42

18.5. Alarms ....................................................... 43

18.6. Air and Oxygen Supplies........................... 43

18.6.1. Oxygen supply....................................... 43

18.6.2. Air supply............................................... 43

18.6.3. Flow rates.............................................. 43

18.7. Power , Dimensions etc............................. 43

18.8. Environmental Storage Conditions............ 44

19. EMC compliance ........................................ 45

19.1. Electromagnetic immunity ......................... 46

19.2. Recommended separation distances between

portable and mobile RF communications equipment

and the SLE2000 HFO ....................................... 48

20. Pneumatic Diagram ................................... 49

21. Consumables and Accessories ............... 52

Page 5

How to use the SLE2000 HFO

NOTE: The warnings (page 10) must be read and understood before using the

SLE2000 HFO ventilator. Failure to do so could lead to injury or death.

1 PERFORM THE FUNCTIONAL TESTS : PAGE 14.

(This should take no more than 20 minutes)

2 SETUP THE SLE2000 HFO IN THE CHOSEN MODE: PAGE 18.

3 THE SLE2000 HFO IS READY FOR USE

For more information see technical section page 24.

For trouble shooting see troubleshooting chart page 34.

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Page 7

Introduction

Page 8

1. Introduction

The SLE2000 HFO ventilator is designed for use on

neonates/infants. Its principle of operation is time

cycled, pressure limited ventilation using a constant

fresh gas flow.

Main features are that it has no expiratory valve but

uses a reverse flow of mixed gas that is injected into

the expiratory limb of the patient circuit from the

exhaust manifold. This flow of gas has the effect of

compressing 5 l/min 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. Also

the fresh gas flow does not require adjusting for

various rates. Another advantage is that the driving

flow in the exhaust manifold is controlled by a

regulator and therefore provides constant pressure

at all breathing rates.

The oscillatory feature is provided by a rotating jet,

driven by a motor, situated at the rear of the exhaust

block. From this jet a stream of driving gas is rotated

into the exhalation manifold which provides both, an

active inspiratory and active expiratory flow. It can

also be combined with a conventional mode such

that we can have oscillation superimposed on the

inspiratory pressure plateau, or during the expiration

phase, or a combination of both. Finally with the

ventilator operating in the CPAP mode, the

SLE2000 HFO can act as a pure oscillator where

the mean airway pressure is adjusted via the CPAP

control, and the differential pressure can be set by

the oscillation regulator.

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.

Additionally the SLE2000 HFO has a built in oxygen

monitoring cell, fresh gas and leak alarms.

1.1 intended use

The ventilator is designed for use on neonatal and

paediatric patients from 300g to 10 kg in the

following invasive modes: CPAP, CMV, PTV, SIMV

& HFO.

The ventilator is designed to be used in a clinical

environment (example a hospital NICU or similar)

where medical grade gas and power supplies are

present.

1.2 Principles of Operation SLE 2000

HFO

The patient circuit is supplied with a constant fixed

flow of fresh gas at 5 litres per minute. This gas

comes from the internally mounted Oxygen Blender

and its concentration is monitored by a fuel cell and

displayed on the FlO2digital 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. This circuitry

requires a restrictor fitted into the Inspiratory port of

the patient circuit. Therefore, only SLE2000

approved patient circuit must be used with this

equipment.

The Exhalation block mounts onto two pressure

manifold blocks. The front block has two nozzles.

The first is used to generate CPAP/PEEP via the

CPAP/PEEP regulator, by generating an opposing

flow to the fresh gas in the exhalation tube thus

creating CPAP/PEEP. The second is used to

generate the peak Inspiratory pressure. The

Inspiratory regulator sets the pressure that is

supplied to a solenoid valve which is connected to

the rear nozzle.

The Electronic Section controls the rate and

duration of opening of the solenoid valve.

When the valve is open the Driving Gas enters the

expiratory tube in opposition to the Fresh Gas flow.

This opposing flow acts as a pneumatic piston and

creates a pressure plateau at the ET connector

The lung inflation pressure and hence the tidal

volume are controlled by the Inspiratory regulator in

conventional ventilation.

The same gas mixture from the Oxygen Blender is

used to supply the patient Fresh Gas, CPAP,

Inspiratory and Oscillation driving gas pressure.

This avoids any possibility of dilution of the Fresh

Gas mixture.

There is a wave shape switch. This modifies the

Driving Gas flow rate from the Solenoid valve

through the nozzle and is used to slow down the rise

time of the pressure waveform. In the taper position

The rise time is approximately 250 ms.

Page 9

The second or rear manifold block is the High

Frequency Oscillator pressure generator. Creating a

pressure by means of a spinning jet of gas thus

providing an active positive and negative waveform

(Sinusoidal). Pressure is controlled via the oscillator

regulator and frequency via the Frequency or Rate

control.

When operating the HFO in Inspiratory or expiratory

mode, gas release is controlled via a solenoid

synchronised with the Inspiratory time and BPM.

2. User/Owner Responsibility.

This SLE 2000 HFO 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 10

3. Warnings

3.1 Operational Warnings

The following warnings must be read and

understood before using the SLE2000 HFO

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 HFO

Operators must be suitably trained and

clinically authorised for using the SLE2000

HFO with patients. Particular care should be

taken to check the ventilator pressures prior to

changing modes.

2 Oxygen - Clinical use. Oxygen is a drug and

should be prescribed as such.

3 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.

4 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/PtCO2will dependably alert the

medical team to an alarm situation, not the

monitoring of pressures.

5 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.

6 The ventilator functional tests must be carried

out each time the SLE 2000 HFO 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.

7 The humidifier used in the patient circuit must

be operated and maintained in accordance

with its manufacturer’s instructions.

8 An alternative form of ventilation should be

available whenever the ventilator is in use.

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.

11 Functioning of this ventilator may be adversely

affected by high frequency surgical

(Diathermy) defibrillators, short-wave therapy

or equipment producing strong magnetic fields,

operating in the vicinity.

12 The Ventilator must be connected to 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 suitable for use with, or

in the presence of flammable anaesthetic

mixtures.

15 Do not cover the ventilator during use or allow

the ventilator to become covered by any fabric

or curtain. Do not allow the exhaust ports or

inlet vents to become obstructed or blocked by

positioning the ventilator near curtains or

fabric.

16 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.

17 The electronic module of the ventilator

contains a primary battery, 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 Use only SLE approved patient circuits. On no

account should antistatic or electrically

conductive tubing be used in the patient circuit.

20 The patient circuit should not be modified.

Modified patient circuits or circuits with

additional sections or components may

produce too high a circuit resistance and circuit

compliance for effective ventilation.

21 Use of non approved patient circuits may

cause inadvertent block or leaks alarms.

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