Elisee 150 Clinical Manual July 2010

Elisée™ 150

Clinical Manual English

NOT013189-5 07 10

ResMed Schweiz AG Viaduktstrasse, Basel, Switzerland, +41 61 564 7000. Saime SAS (Manufacturer), Z.I., 25 rue de l’Etain, 77176 Savigny-le-Temple, France. ResMed Corp Poway, CA, USA +1 858 746 2400, ResMed Ltd Bella Vista, NSW, Australia, +61 (2) 8884 1000. ResMed has offices in Austria, Brasil, China, Finland, France, Germany, Hong Kong, India, Japan, Malaysia, the Netherlands, New Zealand, Norway, Singapore, Spain, Sweden, Switzerland and the United Kingdom (see www.resmed.com for details). Protected by the following patents: FR 0303538, FR 2766568, US 6164141. Other patents pending. Elisée is a trademark of Saime SAS. The technical specifications may be changed without notice. © 2007 Saime SAS is a subsidiary of ResMed Inc.

Foreword Contents of the Manual This clinical manual is for an Elisée™ 150 ventilator with a software version of 2.3X or higher. The manual is divided into sections. A summary of the information contained in each section is given below: • General Safety Instructions: precautions relating to use of the ventilator; • Introduction and Description: description of the ventilator and its accessories; • Installation: installation of the ventilator and its accessories; • Ventilation: description of the ventilation modes and associated parameters; • Clinical Configuration and Use: using the ventilator - turning it on and off, entering ventilation settings in clinical mode; • Patient Use: using the ventilator in Patient mode - turning it on and off; • Alarms: description of the alarms and troubleshooting guide; • Maintenance and Disinfection: procedures for cleaning the ventilator and accessories and preventative maintenance schedule; • Specifications and Technical Description: description and technical specifications for the ventilator and its accessories, relevant standards; • Appendices: list of parts and accessories, list of ventilation settings and measurements, list of symbols and abbreviations.

Definitions This manual contains special terms and icons that appear in the margins. Their purpose is to draw your attention to specific or important information.

!

Caution

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Warning

Explains special measures for the safe and effective use of the ventilator. Alerts you to possible injury. Note: Is an informative or helpful note.

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Contents Foreword... iii 1 General Safety Instructions... 11 2 Introduction and Description... 13 2.1 Purpose of the Elisée 150 2.2 Description of the ventilator’s exterior 2.3 Description of power sources

13 14 17

Mains power pack ... 17 External DC power supply ... 18 External battery pack ... 19 Internal battery ... 19 Power status information ... 20

2.4 Description of the gas supplies

21

Air inlet ... 21 Oxygen port ... 21

3 Installation... 23 3.1 Power supplies

23

Mains power pack ... 23 External DC power supply ... 24 External battery pack ... 25

3.2 Gas supply

26

Air inlet ... 26 Low-pressure oxygen ... 26

3.3 Patient circuits and accessories

28

Connection of the single limb circuit and double limb circuit expiratory supports ... 29 Connecting a single limb patient circuit ... 30 Connecting a double limb patient circuit ... 31 Connecting accessories ... 32

3.4 Turning the Elisée 150 on and off

35

Turning on ... 35 Using the touch screen ... 35 Turning off ... 36

4 Ventilation... 39 4.1 Ventilation parameter definitions 4.2 Ventilation modes

39 48

(Assisted) Controlled Ventilation ((A)CV and P(A)CV) ... 48 Intermittent Assisted Controlled Ventilation (Synchronised Intermittent Mandatory Ventilation) SIMV and PSIMV ... 52 Spontaneous ventilation (PS.SV (PS) and PS.VT) ... 56

v

5 Clinical Configuration and Use... 63 5.1 Accessing the clinical screens 5.2 Manual test 5.3 Programming ventilation options

63 65 70

Using the new patient icon ... 70 Using the P1 and P2 buttons ... 72 Modifying the patient configuration ... 73 Changing the ventilation mode ... 74 Adjusting ventilation parameters ... 75 Starting and stopping ventilation ... 80

5.4 Monitoring ventilation

81

Measurements ... 82 Event log ... 83 Preparing the settings for monitoring in Easyview 150 ... 86

5.5 Changing mode during ventilation 5.6 Parameter options

89 91

Parameter options screen ... 91 Description of the parameter options ... 92

5.7 Specific settings

93

Calibrating the touch screen ... 93 Empty curves/filled curves ... 94 Screen brightness and digital sound (volume level) ... 95 Date and time ... 97 Assigning program names ... 99

5.8 Exiting the clinical screens

102

6 Patient use... 103 6.1 Main patient screen 6.2 Patient mode settings screen 6.3 Starting and stopping ventilation in patient mode

103 104 105

Starting ventilation in patient mode ... 105 Stopping ventilation in patient mode ... 105

6.4 Measurements screen 6.5 Changing ventilation program during ventilation 6.6 Screen brightness/Digital sound volume

106 107 108

Accessing the setting screen ... 108 Setting ... 108

6.7 Calibrating the touch screen 6.8 Power supply and patient timer information

109 110

Power supply ... 110 Patient timer ... 111

7 Alarms... 113 7.1 Monitoring the alarms

113

Silencing audible alarms ... 113

7.2 List of ventilation monitoring alarms 7.3 General alarms causes and remedies 7.4 Alarm checking procedure

114 116 120

Testing the mains power and external DC power alarms ... 120 Testing settings alarms for use with single or double limb circuits ... 121 Testing settings alarms for use with a double limb circuit ... 124 Testing settings alarms for use with a single limb circuit ... 125

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8 Maintenance and Disinfection... 127 8.1 Cleaning and maintenance frequency

127

Cleaning frequency ... 127 Preventative maintenance frequency ... 127

8.2 Maintenance, cleaning and replacement of wearing parts

128

Patient circuit and expiratory valve clapper ... 128 Humidifier ... 128 The ventilator’s exterior ... 129 Replacing the anti-dust filter ... 130 Replacing the O2 cell ... 131 Double limb circuit expiratory support ... 133

9 Technical Specifications and Description... 135 9.1 Technical description and operation

135

Technical description ... 135 Operation of the ventilator ... 136 Pressurised air flow diagram – Single limb circuit ... 137 Pressurised air flow diagram – Double limb circuit ... 138

9.2 Technical specifications for the Elisée 150

139

Electrical specifications ... 139 Battery life ... 139 Pressurised air specifications ... 142 Specifications and performance data ... 142 Operating, storage and transport conditions ... 145

9.3 Technical specifications for accessories 9.4 Applicable standards

146 148

10 Appendices... 149 10.1 Spare parts and accessories 10.2 Parameters and measurements

149 150

Parameter interdependence ... 150 Ranges of adjustment, accuracies and default values ... 152

10.3 Abbreviations and symbols

156

List of Figures... 165 List of Tables... 169 Index... 171

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1 General Safety Instructions The following are general safety instructions. Other specific warnings and notes can be found throughout the text of the manual. This manual must be read and understood in full by the user before the device is used by a patient.

Use • The Elisée 150 must not be covered or positioned in a way which could impede ventilation. • Before connecting the patient to the ventilator, check the whole of the patient circuit to

eliminate any risk of leaks or defective parts. • Alarms should be checked and adjusted before the device is used for a new patient. They

• • • •

• •

should also be checked and adjusted regularly when the device is being used for home ventilation. These checks could be included in regular servicing. The ventilation settings must be decided and applied under the supervision of a physician or qualified and trained staff. Do not use the ventilator with antistatic or electrically conductive patient circuits. It is recommended that you have an alternative means of ventilation available. For ventilation-dependent patients, it is vitally important that you monitor the ventilator while it is in operation. Ensure that the person caring for the patient is capable of taking the necessary corrective action if an alarm is triggered or if the device malfunctions. Do not use the ventilator if there are obvious external defects or unexplained changes in performance. The ventilator and its clinical manual have received CE marking (notified body: TÜV Rheinland, CE 0197). All accessories used must be CE-marked and must comply with the relevant standards.

Operation • Do not use this device in the presence of flammable anaesthetic agents. • Several different pressure measurement units are used in this manual, to correspond to the

usual measurement units. 1mbar = 1hPa = 1.016cmH2O. • The user must ensure that the total resistance of the patient circuit and ventilation

accessories does not exceed 6hPa (= 6.096cmH2O) for a flow rate of 60 L/min in adult ventilation, or 6 hPa for a flow rate of 30L/min in paediatric ventilation.

Technical characteristics • The pressure in the device will not be lower than atmospheric pressure during the expiratory

phase. • The maximum pressure delivered by the device cannot exceed 60 - 70hPa (= 61.0 - 71.1cmH2O). • The ventilator design ensures that, if the device were to stop, the patient would be able to breathe spontaneously and would not rebreathe exhaled air.

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Servicing and maintenance • The manufacturer accepts no liability for damage to the device caused by maintenance or

• • • • • •

modifications which do not comply with the instructions provided and which do not have the manufacturer's prior approval, or which have been carried out by unauthorised persons. There is a technical manual for the ventilator, which is issued at ResMed training sessions. It must be read and understood by the technicians responsible for servicing the ventilator. If anything unexpected occurs,contact your ResMed representative. To avoid the risk of electrocution, do not open the shell. All procedures should be carried out by a technician trained in the maintenance of the ventilator. Do not obstruct the vents. Before using the device for the first time, and also between patients, the accessories should be cleaned and disinfected. Replacement fuses must be identical to the old ones, and comply with the same standards. Replacement must be carried out by a qualified technician.

Power supply • If there is interference on the electrical network, operate the ventilator on battery power. • The electricity source used for the ventilator must comply with the current standards. • Use the specific power cord supplied with the ventilator.

Electromagnetic compatibility • The user must ensure that the operation of the ventilator is not impaired by the concurrent

use of devices such as defibrillators or diathermy, electrosurgery or radiology equipment or mobile phones. • The device may be affected by electromagnetic fields greater than 10V/m.

Transport and storage • This device is not protected against water penetration (IPX0). During transportation we

recommend using the device in its bag, to provide maximum protection against accidental splashes. • The ventilator must not be exposed to direct sunlight. • The ventilator must not be subjected to any violent impact. • The ventilator must not be turned on immediately after storage or transport in conditions different from the recommended operating conditions.

Recycling • In accordance with directive 2002/96/EC concerning waste electrical and electronic

equipment, this device must be disposed of separately from other types of rubbish. It must not be disposed of with ordinary municipal waste. To dispose of this device, use the appropriate waste collection, reuse and recycling system available in your region.

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2 Introduction and Description 2.1 Purpose of the Elisée 150 The Elisée 150 is a valve ventilation device delivering both pressure and volumetric ventilation, making it suitable for ventilating adult or child patients, at home and/or in a hospital setting. It is not designed for neonatal ventilation and should not be used with circuits with a 10mm diameter. The circuit type chosen should be: • 15mm in diameter for ventilation with a tidal volume between 50 and 300mL; • 22mm in diameter for ventilation with a tidal volume > 300mL.

The device can be used with a single limb circuit and an expiratory valve, or with a double limb circuit. The Elisée 150 is designed to be used for both dependent and non-dependent patients. This ventilator is fitted with an internal battery which is automatically used if the mains power supply or external DC power supply is lost. The Elisée 150 is designed to ensure that the patient is not affected by device malfunctions, using a system of automatically triggered alarms. However, it is preferable for the patient to have a backup means of ventilation close by. Depending on the patient's condition, a backup Elisée 150 may need to be provided.

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2.2 Description of the ventilator’s exterior 1. Mains or external power supply LED (see "Power status information" on page 20). 2. Retractable handle. 3. Internal and external battery LEDs: indicate the battery charge levels. 4. Alarm Silence button. 5. Brightness sensor: automatically adjusts the screen contrast. 6. Data exchange LED: green and flashing when data is being transferred via the serial port. 7. Bluetooth LED: steady blue when a connection is established. 8. Touch screen: lets you view and adjust the various parameters.

9

10

8

7

6

INT.

1

EXT.

5

3

4

2

Figure 2.1: Top view.

9. Single or double limb circuit expiratory support (interchangeable). 10. Insufflation outlet. 11. Mains power pack or external battery pack (interchangeable).

9

10

11

Figure 2.2: View of left side with double limb circuit expiratory support.

9

10

11

Figure 2.3: View of left side with single limb circuit expiratory support.

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12. External DC power socket 12 - 28V / 15A max. 13. On/Off push button. 14. Serial link cable connection socket for connecting to a PC. 15. Remote alarm socket.

12

14

13

15

Figure 2.4: View of right side.

16.Low-pressure O2 port connection. 17. Air inlet. 18. Access to the O2 cell (optional).

17 18 16

Figure 2.5: Rear view.

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19. Manufacturer plate. 20. Ventilator serial number. Table 2.1: Description of a specimen serial number, e.g. EL2D0701001

EL2D

07

01

001

Product code

Year of manufacture

Month of manufacture

Sequential manufacture number

21. Compartment for mains power pack or external battery pack. 22. Speaker. 23. Item code (e.g. PACXXXXXX).

17

22

20 19

21

–

23

Figure 2.6: view underneath.

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2.3 Description of power sources The Elisée 150 can operate with four different power sources. The device automatically selects the most secure available power source according to the following order of priority: 1. Mains AC voltage: 100-230VAC / 50-60Hz / 0.6-1A (mains power pack inserted in the Elisée compartment). 2. DC voltage from an external source: 12-28VDC / 15A max. 3. External battery pack inside the external battery pack/mains power pack compartment. 4. Internal battery. In the event of a power cut or if the mains power cord is disconnected, an audible and visual alarm is activated. It can be stopped by pressing the Alarm Silence button .

Mains power pack This pack is used for connecting the ventilator to the mains supply (see "Mains power pack" on page 23).

Figure 2.7: Mains power pack.

This pack can also be used outside of its compartment, in which case it is connected to the ventilator using the external power cord. This arrangement enables the ventilator to operate on mains power and recharge the external battery at the same time (see "Figure 3.2: Connecting the mains power pack outside of its compartment." on page 24 or see "Figure 3.4: Elisée 150 with external battery pack and DC power source." on page 25). Note: When powered using the external power cord, the ventilator treats this supply as an external supply, not a mains supply.

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External DC power supply

External power supply cord (mains power pack/Elisée connection)

12-28 VDC power cord

Figure 2.8: External DC power cords.

An external DC power source (in a vehicule with 12-28V, 15A max.) can be used by connecting the external power cord to the right side of the ventilator (see "Figure 3.3: 12-28VDC power cord, connected." on page 24). Note: The external DC power source must have a guaranteed life of at least one hour. If the external power supply is less than 19 +/- 1V, the batteries will not be recharged.

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External battery pack

Figure 2.9: Li-Ion external battery pack.

This battery pack is attached and removed in the same way as the mains power pack (see "Mains power pack" on page 23). This power supply takes priority over the internal battery. Note: The external battery pack should be disconnected when the ventilator is switched off. The external battery is recharged when the ventilator is connected to the mains power pack using the external power cord or to an external DC supply (see "Figure 3.4: Elisée 150 with external battery pack and DC power source." on page 25). Note: When the external battery charge drops below 5%, the Elisée 150 switches to the internal battery.

Internal battery This battery is inside the ventilator. It is used when the ventilator is not connected to the mains supply, to an external DC supply or to the external battery. Whenever the ventilator is connected to an external power source (mains supply or external DC supply) of more than 19 +/- 1V, the internal battery is automatically recharged. Note: When the charge level falls below 15%, the Battery Low alarm is triggered. Within a minimum of 5 minutes, this alarm is followed by the Battery Empty alarm (charge less than 5) signalling that ventilation will stop. Once ventilation has stopped, the device will shut down completely within a minimum of 5 minutes. During this time, connecting the device to a power source (other than the external battery) will immediately restart ventilation.

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Power status information There are three LEDs on the top of the device showing the status of the power sources. Table 2.2: Power status information Power source

Symbol and LED status

Meaning

Mains or external.

Green.

Mains power pack or external DC supply present.

Off.

Neither mains power pack nor external DC supply present.

Green.

Battery charged.

Green light, flashing slowly.

Battery discharging: more than 15% capacity remaining.

Orange light, flashing slowly.

Battery discharging: less than 15% capacity remaining.

Red light, flashing slowly.

Battery discharging: less than 5% capacity remaining.

Orange light, flashing rapidly.

Battery charging interrupted (battery temperature too high).

Green light, flashing rapidly.

Battery charging.

Internal battery or external battery.

Note: If the ventilator is operating on battery power alone, you must ensure it is adequately charged (green light, flashing slowly). If not, connect the ventilator to the mains supply. The battery charge is displayed one minute after the ventilator is started: one stroke in the battery symbol indicates a charge level of around 25%.

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2.4 Description of the gas supplies Air inlet for gas supply Oxygen port

Figure 2.10: Gas supply.

Air inlet Ambient air passes through a removable anti-dust filter before arriving in the pressurised air circuit.

!

Caution Do not obstruct this filter.

Oxygen port The VS Ultra/VS Integra has a low-pressure oxygen port (maximum 400kPa and 15L/min). The air is enriched with oxygen through a special detachable metal connector (see "Spare parts and accessories" on page 149).

Figure 2.11: Metal connector.

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