User Manual
79 Pages
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SLE2000 User manual
Contact Information:
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
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 06/09/2013. Manual : UM91 Issue 4 SLE Part Nº: N2000/FL
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1. Introduction ... 10 1.1. Intended Use ... 10 1.1.1. Intended User ... 10 2. Principles of Operation SLE2000 Valveless System ... 11 3. User/Owner Responsibility ... 12 4. Warnings ... 14 4.1. Operational Warnings... 14 4.2. Clinical Warnings... 17 5. Ventilator Description ... 20 5.1. Front Panel ... 20 5.2. Function of Front Panel Controls and Indicators ... 21 6. Symbols ... 23 7. Functional Tests ... 26 7.1. Pressure Regulators and Gauges ... 26 7.2. Pre-setting alarm limits ... 27 7.3. Power On Automatic Test... 27 7.4. Pressure Display ... 27 7.5. CMV Mode ... 28 7.6. PTV Mode ... 29 7.7. SIMV Mode... 29 7.8. Alarm Test ... 30 7.8.1. Low CPAP ... 30 7.8.2. High and Cycle Fail Alarm ... 30 7.8.3. Leak and Block Alarms ... 31 7.8.4. Mains failure alarm ... 31 7.8.5. O2 Blender Alarm... 32 7.9. Condition of O2 Cell. ... 32 7.10. Completing Functional Testing ... 32 8. Basic Setup ... 34 8.1. To Use the SLE2000 in CPAP Mode... 35 8.1.1. Manual breaths in CPAP mode. ... 35 8.2. To Use the SLE2000 in CMV Mode ... 36 8.2.1. Manual breaths in CMV mode. ... 36 8.3. Patient Triggered Modes ... 37 8.3.1. To use SLE 2000 in PTV and SIMV mode ... 37 8.3.2. Manual breaths in PTV. ... 37 8.3.3. Manual breaths in SIMV. ... 37 9. Technical Information ... 40 9.1. Electronic module ... 40 9.1.1. Power Switch (5 positions) ... 40 9.1.2. System Fail LED ... 40 9.1.3. CPAP Mode ... 40
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9.1.4. CMV Mode ...40 9.1.5. PTV Mode ...41 9.1.6. SIMV Mode...41 9.1.7. BPM...43 9.1.8. Inspiration Time...43 9.1.9. I:E Ratio...43 9.1.10. Oxygen (FlO2 ) ...43 9.1.11. Pressure Display ...43 9.1.12. Three position switch...44 9.1.13. Pressure Wave Switch ...44 9.1.14. Manual Breath ...44 9.2. Pneumatic Module ...45 9.2.1. Proximal Airway...45 9.2.2. Fresh Gas Port ...45 9.2.3. Removable Exhalation Block N2190 ...45 9.2.4. Regulator and Pressure Gauges...46 9.2.5. O2 Blender (% FlO2 ) ...46 9.2.6. Option 3...46 10. Alarms ...47 10.0.1. System fail...47 10.0.2. Mains Failure Audible Alarm ...47 10.0.3. Gas Supply Failure Alarm ...47 10.0.4. Fresh Gas Fail Alarm (Block & Leak) ...48 10.0.5. Adjustable Alarm ...48 10.0.6. High Alarm...48 10.0.7. cycle Fail Alarm ...48 10.0.8. Low CPAP Alarm...49 10.0.9. O2 Blender Alarm ...49 10.0.10. Alarm Mute ...49 10.0.11. Alarm Volume...49 10.0.12. Alarm Verification ...49 11. Auxiliary Output ...50 12. Rear Panel ...51 13. Patient Circuit Connection ...52 14. Filter Systems ...53 14.1. Bacterial filter, SLE Part Nº:N2029 (Autoclavable) ...53 14.2. Bacterial filter, SLE Part Nº:N2587 (Single use) ...53 14.2.1. Precautions when using bacterial filter N2587 ...53 15. Commissioning procedure ...54 15.1. Preparation of a new ventilator ...54 16. Cleaning, Disinfection and Sterilization ...55 16.1. Cleaning and disinfection of an in-service ventilator...55 16.1.1. Cleaning, Disinfection & Sterilization chart...56
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16.2. Cleaning method ... 56 16.3. Disinfection method ... 57 16.4. Sterilization method ... 57 17. User Operational Checks ... 58 18. SLE2000 Trouble Shooting Chart ... 59 19. Service Programmes ... 62 20. Pressure unit conversion constants ... 64 21. Technical Specification ... 65 21.1. Conventional Ventilation... 65 21.1.1. Spontaneous breathing during power failure ... 65 21.2. Displays ... 65 21.3. Controls ... 66 21.4. Alarms ... 67 21.5. Air and Oxygen Supplies ... 67 21.5.1. Oxygen supply ... 67 21.5.2. Air supply ... 67 21.5.3. Blender flow rate... 67 21.6. Power, Dimensions etc... 68 22. EMC compliance ... 69 22.1. Electromagnetic immunity ... 70 22.2. Recommended separation distances between portable and mobile RF communications equipment and the SLE2000 ... 72 23. Pneumatic diagram ... 73 24. Consumables and Accessories for SLE 2000 ... 74 25. Ordering Information ... 77 26. Glossary of Abbreviations Used in This Manual ... 78
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How to use the SLE2000 NOTE THE WARNINGS (PAGE 14) 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 26 (THIS SHOULD TAKE NO MORE THAN 20 MINUTES)
2 SETUP THE SLE2000 IN THE CHOSEN MODE: PAGE 34
3 THE SLE2000 IS READY FOR USE
FOR MORE INFORMATION SEE TECHNICAL SECTION PAGE 40 FOR TROUBLE SHOOTING SEE TROUBLESHOOTING CHART PAGE 59
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Introduction
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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 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.
1.1 Intended Use The ventilator is designed for use on neonatal, and pediatric patients from 300g to 10 kg, in the following invasive modes, CPAP, CMV, PTV & SIMV. 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. 1.1.1 Intended User The ventilator is to be used by appropriately clinically trained and authorised personnel only.
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2. Principles of Operation SLE2000 Valveless System* The patient circuit is supplied with a constant fixed flow of 5l/min 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 inspiratory 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.
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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.
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Operational and Clinical Warnings
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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 ventilator. Operators must be suitably trained and clinically authorized for using the ventilator 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.
When using the SLE2000 an external oxygen monitor must be used. Monitoring must be from the inspiratory limb of the patient circuit.
5.
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.
6.
Audible and Visual warning alarms indicate a potentially harmful condition to the patient.
7.
Check that the alarm mute button operation is not impaired or that the button has been mechanically disabled.
8.
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.
9.
Never turn the unit OFF when connected to a patient.
10. An alternative form of ventilation should be available whenever the ventilator is in use. 11. Please read the operational notes, for information relating to ventilation options and operational practice when the ventilator is connected to a patient. 12. Do not touch the patient and ventilator metalwork at the same time to avoid earthing the patient. 13. The 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.
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Ventilator 14. The ventilator is not protected against the ingress of water. (IPX0) 15. Do not cover the ventilator 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. The ventilator does not support automatic record keeping. 17. The ventilator has no emergency air intake. 18. When the ventilator is used with a 3mm or smaller size endotracheal tubes, in the case of patient extubation or the ET tube disconnecting from its ET connector, only the monitoring of SpO2, or of transcutaneous Oxygen and Carbon Dioxide will dependably alert the medical team to an alarm situation, not the monitoring of pressures. 19. 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. 20. Ensure that the operation of the mute button is not impaired. 21. 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. 22. The Ventilator must be connected to a suitably rated and grounded electrical power source. The ventilator must not be started or used on battery power alone. 23. If the ventilator is adversely affected by equipment emitting electromagnetic interference then that equipment should be switched off or removed from the vicinity. Conversely, if the ventilator is the source of interference to other neighbouring equipment, it should be switched off or taken to another location. 24. 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. 25. The equipment is not suitable for use with, or in the presence of flammable anaesthetic mixtures. 26. Disposal of the Oxygen cell should be in accordance with local regulations for hazardous substances. Do not incinerate. SLE offer a cell disposal service.
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27. 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. 28. The ventilator contains one AA size alkaline battery. At the end of its useful life the battery should be disposed of in accordance with the local authority guidelines. 29. Apart from a AA battery, 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. 30. Care should be taken when attaching other equipment as this may affect mechanical stability. 31. There is no special protection provided against ingress of water or liquids. 32. When using the ventilator with Nitric Oxide therapy devices, two N4110 filters are required to scavenge all the waste Nitric Oxide. 33. Do not use solvent based cleaning solutions to clean the touch screen or covers.
Humidifier / Patient Circuit 34. Use only SLE approved patient circuits. On no account should antistatic or electrically conductive tubing be used. 35. Use of non approved patient circuits may cause inadvertent block or leaks alarms. 36. The humidifier used in the patient circuit must be operated and maintained in accordance with its manufacturer’s instructions. 37. Any water trap used in the patient circuit must be held in the upright positions and drained regularly before it is full. 38. 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. 39. The use of bacterial filters between the fresh gas port and humidifier supply line & exhalation block and the expiratory supply line is strongly recommended. 40. 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.
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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).
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 concentrations 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
Transcutaneous 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.
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Ventilator Description
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5. Ventilator Description The SLE 2000 consists of two linked modules, Electronic and Pneumatic.
Electronic Module
Pneumatic Module
5.1 Front Panel 3
5 6
4
7
9
8
10
11
12 13
2 14 1
15
28 16
27
17
26
18
25
24
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23
22
21
20
19