Elisee 150 Clinical Manual Aug 2008

Elisée™ 150

Clinical Manual English

ResMed Paris (Manufacturer), 240 rue de la Motte, 77 550 Moissy-Cramayel, France. ResMed Schweiz AG Viaduktstrasse, Basel, Switzerland, +41 61 564 7000. 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 ResMed Paris. The technical specifications may be changed without notice. © 2008 ResMed Paris is a subsidiary of ResMed Inc. Created: Aug. 2008

0197

Foreword Contents of the Manual This Clinical Manual is for the Elisée™ 150 Li-Ion ventilator, with software version V2.50 or higher. This manual is divided into sections: General safety instructions: Precautions relating to use of the ventilator; Introduction and description: Description of the ventilator and its accessories; Ventilation: Description of the ventilation modes and associated parameters; Setup: How to set up the ventilator and its accessories; Ventilator configuration and operation: Turning the ventilator on and off, setting ventilation parameters, patient use; • Maintenance and disinfection: Procedures for cleaning the ventilator and accessories and preventative maintenance schedule; • Alarms and troubleshooting: Description of the alarms and troubleshooting guide; • Technical specifications: Description and technical specifications of the ventilator and its accessories; associated standards; list of parts and accessories; list of symbols and abbreviations. • • • • •

All measurements of pressure are given in cmH2O. 1 cmH2O = 0.984 hPa = 0.984 mBar.

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

!

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.

iii

Contents Foreword 1 Safety instructions... 9 General advice ... 9 How to use ... 9 Power supply ... 9 Oxygen ... 10 Electromagnetic compatibility ... 10 Technical specifications ... 10 Servicing and maintenance ... 10 Transport and storage ... 10 Recycling ... 11

2 Description... 13 2.1 Purpose of the Elisée 150 2.2 Description of the ventilator

13 14

Top view ... 14 Touch screen and LCD screen ... 14 Left shoulder ... 15 Right shoulder ... 15 Rear view ... 16 Underside view ... 16

2.3 Power supplies

16

1st Priority: Mains power pack and external DC power supply ... 17 2nd Priority: External battery pack ... 17 3rd Priority: Internal battery ... 18

2.4 Gas supplies 2.5 Features at a glance

18 19

Adjustable touch screen ... 19 User interface ... 19 Ventilation programs ... 19 Low-pressure oxygen monitoring ... 19 Ventilation modes ... 19 Sensitivity to patient effort (triggers) ... 19 Ventilation monitoring ... 19 Battery life ... 20

2.6 Accessories

20

3 Ventilation... 21 3.1 Ventilation parameters

21

Pressure support and inspiratory pressure Pi (cmH2O) ... 21 Positive end expiratory pressure PEEP (cmH2O) ... 21 Inspiratory time Ti (s) ... 21 I:E ratio (inspiration to expiration ratio) ... 21 Maximum inspiratory time Ti Max (s) ... 22 Apnea time Tapnea (s) ... 22 Tidal volume VT (mL) ... 22 Backup tidal volume Vts (mL) ... 22 Recruitment cycles ... 23 Max. flow Vmax (L/min) ... 23 Flow shape ... 23 Respiratory rate F (breaths per minute, bpm) ... 24 Backup rate Fmini (breaths per minute, bpm) ... 24 Rise time ... 24 Expiratory trigger Tg Exp ... 25 Inspiratory trigger TgI ... 26

v

3.2 Ventilation modes

26

Spontaneous ventilation with continuous positive airway pressure (CPAP) ... 26 (Assisted) Controlled Ventilation ((A)CV and P(A)CV) ... 27 Synchronized Intermittent Mandatory Ventilation (SIMV and PSIMV) ... 30 Spontaneous ventilation (PS.SV (PS) and PS.VT modes) ... 32

3.3 Ventilation settings and measurements

36

Adult ventilation settings ... 36 Paediatric ventilation settings ... 37 Triggers ... 38 Units of measurement and accuracy (actual and displayed measurements) ... 38 Interdependence between settings and measurements ... 39

4 Setting up... 41 4.1 Power supplies

41

Mains power pack ... 41 External DC power supply ... 42 External battery pack ... 44

4.2 Patient circuits

44

Fitting the circuit support (single or double) ... 44 Connecting the patient circuit (single or double) ... 45

4.3 Low-pressure oxygen

47

Connecting an oxygen supply ... 47 Activating and deactivating the oxygen monitoring ... 47

4.4 Other accessories

48

5 How to use... 51 5.1 Starting up

52

Switching on the device ... 52 Starting ventilation ... 52

5.2 Unlocking the screen to access the Clinical menu 5.3 Manual test (while ventilation is stopped) 5.4 Setting a ventilation program

53 54 56

How to access the ventilation program settings ... 56 Setting the ventilation mode ... 58 Setting the parameters (during ventilation or while ventilation is stopped) ... 60 Setting the alarms (during ventilation or while ventilation is stopped) ... 62

5.5 Monitoring ventilation

62

Curves ... 62 Measurements ... 63 Event log and clinical log ... 63 Programming the trends ... 65

5.6 Ventilation settings options

66

BTPS correction ... 66 Activating the P2 program ... 66 Selecting target parameters (volume-controlled mode, ACV) ... 67

5.7 Optional settings (during ventilation or while ventilation is stopped)

68

Screen brightness and digital sound ... 69 Setting the date and time ... 70 Assigning names to the ventilation programs ... 71 Calibrating the touch screen ... 72 Appearance of the curves (during ventilation only) ... 72

5.8 Patient use

73

Turning on and off ... 73 Manual test ... 73 Viewing settings (while ventilation is stopped) ... 73 Viewing settings (during ventilation) ... 73 Patient timer ... 74 Changing the ventilation program during ventilation ... 74

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5.9 Stopping ventilation/shutting down the ventilator

74

Clinical menu ... 74 Forced ventilator shutdown ... 75 Patient menu ... 75

5.10 Power supplies

76

Conditions for recharging the internal and external batteries ... 76 Power supply status display ... 76 LEDs on the LED panel ... 77

6 Maintenance and disinfection... 79 6.1 Hospital/Health care facility, Home use and New patient 6.2 List of cleaning/replacement tasks

79 80

1 Mask ... 80 2 Patient circuit ... 80 3 Double circuit support and expiratory valve clapper ... 81 4 O2 sensor ... 82 5 Antibacterial filter ... 83 6 Humidifier ... 83 7 Replacing the dust filter ... 84 8 Ventilator casing ... 84

6.3 Summary table 6.4 Preventative maintenance

85 86

Preventative maintenance schedule ... 86

7 Alarms and troubleshooting... 87 7.1 Alarm signal 7.2 Alarm types

87 88

Ventilation monitoring alarms ... 88 Technical alarms ... 90 Servicing alarms ... 90

7.3 Level of priority and whether alarms can be stopped

91

Priority indicators ... 91 Relative alarm priorities ... 91 Deactivating the audible signal ... 91

7.4 Alarm settings

92

Adult ventilation ... 92 Paediatric ventilation ... 93

7.5 Setting the Pi alarm threshold – special case

93

Example of how to set the Pi alarm threshold ... 94

7.6 Alarm checking procedure

95

Testing the power supply alarms ... 95 Tests which apply to both single and double circuit alarms ... 96 Tests for double circuit-only alarms ... 97 Tests for single circuit-only alarms ... 98

7.7 Troubleshooting

99

8 Technical specifications... 101 8.1 Technical description and operation

101

Technical description ... 101 How the ventilator works ... 102 Block Diagram of Elisée 150 with single circuit ... 103 Block Diagram of Elisée 150 with double circuit ... 103

8.2 Elisée 150 technical specifications

104

Electrical specifications ... 104 Battery life ... 104 Pressurised air specifications ... 106 Specifications and performance data ... 106 Volume level ... 107 Operating, storage and transport conditions ... 107

8.3 Technical specifications for accessories

108

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8.4 Applicable standards 8.5 Operating symbols and abbreviations

109 110

Symbols displayed on the screen ... 110 Symbols on the LED panel ... 112

8.6 Symbols on the device casing

113

Warning and information symbols ... 113 Sockets and connections ... 113 Transport and storage ... 114

8.7 Electromagnetic emissions and immunity 8.8 Spare parts and accessories

114 116

Index... 117

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1 Safety instructions General advice Other specific warnings and notes will be found throughout the text of the manual. This manual must be read and understood in full by the user before the ventilator is used on a patient. This manual is intended for use by physicians, HME providers and nursing staff. There is also 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. • Do not use the ventilator if it is damaged, or if there are obvious external defects or

unexplained changes in performance. • The ventilation settings must be prescribed by the patient's physician. • The ventilation settings must be determined and applied under the supervision of a physician •

• • •

or qualified and trained staff. Monitoring the ventilator is of vital importance for ventilation-dependent patients. Ensure that the person caring for the patient is capable of taking the necessary corrective action if an alarm is triggered or if the ventilator malfunctions. It is recommended that you have a backup means of ventilation available. This ventilator is designed for adult and paediatric ventilation. It is not intended for neonatal ventilation. Use the ventilator with CE-marked accessories only and in compliance with the manufacturer's recommendations.

How to 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. • Do not block the vents on the ventilator. • 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. Do not use the ventilator with antistatic or electrically conductive patient circuits. Do not use this device in the presence of flammable anaesthetic agents. The user must ensure that the total resistance of the patient circuit and ventilation accessories does not exceed 6 cmH2O for a flow rate of 60 L/min (in adult ventilation), or for a flow rate of 30 L/min (in paediatric ventilation). If a technical alarm is triggered, switch off the ventilator and unplug the mains power and oxygen supplies.

Power supply • • • • • •

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Do not use the ventilator if either the power cord or the mains power pack is damaged. If there is interference on the electrical network, operate the ventilator on battery power. The power source used for the ventilator must comply with the current standards. Use the specific power cord supplied with the ventilator. The ventilator must not be connected to a multi-socket plug board or an extension cord. When the ventilator has been disconnected from mains power and stored for an extended period of time, the backup battery will discharge. If the "ADJUST CLOCK" alarm is triggered when the ventilator is turned on, the battery must be recharged by connecting to mains power.

Safety instructions

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Oxygen • We recommend that you disconnect the oxygen port when the ventilator is in standby mode

or turned off. • Do not try to open or pierce the oxygen sensor. • The ventilator is not capable of compensating for changes in atmospheric pressure. The FiO2

measurements may be affected by altitude.

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 10 V/m. • The use of accessories or power cords other than those specified may increase emissions from the ventilator or decrease its immunity.

Technical specifications • The pressure in the ventilator will not be lower than atmospheric pressure during the

expiratory phase. • The maximum pressure delivered by the ventilator cannot exceed 60 – 70 cmH2O. • The design of the ventilator ensures that, if the device were to stop, the patient would be able

to breathe spontaneously and would not rebreathe exhaled air.

Servicing and maintenance • The manufacturer accepts no liability for damage which may occur to the ventilator due to: • Maintenance or changes which do not comply with the instructions provided or do not have

the manufacturer's prior approval; • Maintenance or changes carried out by unauthorised persons. • If anything unexpected occurs,contact your ResMed representative. • To avoid the risk of electrocution, do not remove the covers. All procedures should be carried

out by a technician trained in the maintenance of the ventilator. • Do not block the vents on the ventilator. • 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.

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

recommend using the ventilator 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.

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

equipment, this device must be sorted and 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. • Whether new or worn out, the oxygen sensor contains toxic substances. It must be disposed of in accordance with the applicable waste processing regulations in your region and in accordance with local environmental legislation. Do not burn the sensor: risk of toxic smoke.

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Safety instructions

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2 Description 2.1 Purpose of the Elisée 150 The Elisée 150 is a valve ventilation device capable of delivering pressure-based or volume-based, invasive or non-invasive ventilation to adult or paediatric patients at home or in the hospital. It is not designed for neonatal ventilation. The Elisée 150 can be used with circuits with the following diameters: • 15 mm for ventilation with a tidal volume between 50 and 300 mL; • 22 mm for ventilation with a tidal volume > 300 mL.

It can be used with: • A single circuit, an expiratory valve and a proximal pressure line; or • A double circuit.

The Elisée 150 is designed to be used by both dependent and non-dependent patients. It has an internal battery which is used automatically if the mains or external DC power supply is cut off. The Elisée 150 is designed to ensure that the patient is not affected by device malfunctions, using a system of automatically triggered ventilation monitoring and technical alarms. For ventilation-dependent patients in particular it is advisable to have a second Elisée 150 available as a backup.

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Description

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2.2 Description of the ventilator Top view Interchangeable expiratory circuit support for single or double circuit (double circuit support shown attached)

Touch screen (for setting and viewing the various parameters)

INT.

EXT.

Handle

Data exchange LED (flashes green during transfer via the serial port)

Power supplies: (For details, see Table 5.3 on page 77)

Bluetooth LED (shows a continuous blue light when a connection is established)

Mains or external power supply LED INT.

EXT.

Internal battery LED (charge status) External battery LED (charge status)

Alarm Silence button

Brightness sensor (automatically adjusts the screen contrast)

Figure 2.1: Top view

Touch screen and LCD screen You can select screens and parameters by pressing the buttons, both on the device and on the touch screen.

28 February 11: 28: 31

Wednesday

Intern.

Mains

P1:

ACV

P2:

PS

START VENTIL

 1s

Figure 2.2: Using the touch screen

The Elisée 150 has two levels of access for clinicians: • Access intended for the clinician only (Clinical menu); • Patient access (Patient menu).

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"Closed padlock" symbol

"Open padlock" symbol U

23

cm H2O

ACV

90

info

P

70

16

60

0

15,6 H2O

Press to access settings screens

80 70

Pa ra m

Pressure value (cmH2O)

>

50 HP

40

v 28 0

30

Bar graph <PE

0

Mains

P1:

60 50 40

Ppeak I/E 23.2 1/3,3 cm H2O

FTOT 13

c/ min

VE 6,3

l/ min

Curves

ACV

P2:

20

PS

10

Instantaneous measurements

Clinical menu screen

0

Power supplies currently available Press to access the ventilation program measurements and parameters

< HP

30

20 10

28 February 11: 28: 31 Intern.

Wednesday

90

>

80

M od es

cm

< PE

Patient menu screen

Figure 2.3: Example of a screen in the Clinical menu (left) and a screen in the Patient menu (right) during ventilation

For a list of all of the symbols that appear on the screen, see “Operating symbols and abbreviations” on page 110.

Left shoulder Expiratory circuit support for single or double circuits Expiratory circuit support for double circuit, interchangeable with single circuit support

(for a detailed view of the support, see Figure 4.6, Single and double circuit supports, on page 45) Insufflation outlet Mains power pack or external battery (interchangeable) Figure 2.4: View of the left-hand side with the expiratory circuit support for single or double circuits

Right shoulder External DC power socket 12–28 V / 15 A max. Remote alarm socket (

)

Serial link cable connection socket for connecting to a PC ( ) On/Off button (

)

Figure 2.5: View of the right-hand side

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Rear view Air inlet

Oxygen sensor (optional) with protective cap

Low-pressure oxygen port connection Figure 2.6: Rear view

Underside view Dust filter (air inlet) Speaker Ventilator serial number label: Example: EL2D0807001: Manufacturer plate Product code (PACXXXXXX)

–

Product code

Year of manufacture

Month of manufacture

Manufacture No.

EL2D

08

07

001

Compartment for mains power pack or external battery pack

Figure 2.7: Underside view

2.3 Power supplies The Elisée 150 can operate on three different power sources.

ResMed Power Station

Priority 3 Priority 1 Priority 1

External power source (vehicle) Mains power pack (grey label and 2 connectors) External battery pack (blue label, no connectors)

Priority 2

Mains power pack and external power cord (in this case the pack is considered as an external power supply)

Figure 2.8: Power supply types available to the Elisée 150 and priority of use by the ventilator

The most secure power supply is selected automatically according to the following order of priority, from highest to lowest.

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1st Priority: Mains power pack and external DC power supply Mains power pack The pack is housed in the compartment located on the underside of the ventilator. It ensures a DC power supply from the mains (100–230 V AC / 50–60 Hz / 0.6–1 A) and enables the internal battery to recharge.

Connector for power cord on mains power pack Figure 2.9: Mains power pack, top view (left) and underside view (right)

Note: If used outside of its compartment, the mains power pack is connected to the ventilator with an external power cord and is therefore considered to be an external power supply (see next paragraph). Place the dummy pack in the compartment so that it is never left empty.

External DC power supply A 12–28 V DC / 15 A max. external DC power supply is provided: • Either by the mains power pack connected via its power cord; • Or by the ResMed Power Station equipped with a charger; • Or by a vehicle.

It should allow the ventilator to be operated without mains power for at least 1 hour.

Charger Power Station

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

Cord for connecting to the ventilator

DC power cord for power supply from vehicle

Figure 2.10: Types of external power supply available

2nd Priority: External battery pack Like the mains power pack, the external battery pack is housed in the compartment located on the underside of the ventilator. This power supply takes priority over the internal battery. During ventilation, the battery can be recharged if the voltage is higher than 20 V. However, when ventilation is not being delivered, the battery will recharge whatever the voltage. It is advisable to disconnect the external battery pack if the ventilator is stored for a prolonged period.

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Description

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Blue label

Figure 2.11: Li-Ion external battery pack

The external battery recharges when the ventilator is connected to: • The mains power pack via the external power cord; • An external DC power source. When the charge of the external battery falls below 5%, the Elisée 150 switches to internal battery power.

3rd Priority: Internal battery During ventilation, the battery can be recharged by an external power source (external DC or mains) if the voltage is higher than 20 V. However, when ventilation is not being delivered, the battery will recharge whatever the voltage. Notes: • The "Low battery" alarm is triggered, followed by the "Empty battery" alarm. This indicates that ventilation has stopped. • Once ventilation has stopped, the device will shut down completely after a minimum of 5 minutes. During this time, connecting the device to a power source (other than the external battery) will immediately restart ventilation. If mains power is absent, an audible signal will sound and a symbol will appear on the screen. button to mute the audible signal. Press the Alarm Silence To view the status of the power supplies, see “Power supplies” on page 76.

2.4 Gas supplies Metal coupling for connecting an external low-pressure oxygen supply Low-pressure oxygen port (max. 400 kPa, max. 15 L/min)

Dust filter (filters ambient air as it enters the device and before it reaches the air tubing) Figure 2.12: Gas supply (ambient air and low-pressure oxygen)

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Caution Do not block the air filter (

).

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2.5 Features at a glance Adjustable touch screen The screen, which consists of an integrated touch screen and an LCD screen, can be calibrated quickly and easily. In addition, the screen orientation can be inverted.

User interface The user interface offers three separate menus: • Patient menu (limited access to the functions of the ventilator); • Clinical menu (access to all the functions); • Technical menu (not covered in this manual).

Ventilation programs For the same patient, the Elisée 150 enables you to program: • Two ventilation programs; • Each of which can be in either invasive or non-invasive mode. The patient can switch between programs during ventilation, as long as this is allowed by the patient circuit configuration.

Low-pressure oxygen monitoring The Elisée 150 can receive a supply of low-pressure oxygen. The oxygen supply is connected with a metal coupling. A MOX20 internal oxygen measuring sensor (optional) makes it possible to monitor the FiO2 (oxygen concentration in the volume delivered to the patient).

Ventilation modes • CPAP (Continuous Positive Airway Pressure): Spontaneous ventilation with continuous • • • • •

positive pressure provided to the airways. Volume-Controlled (CV) and Assisted Volume-Controlled (ACV) Ventilation; Pressure-Controlled (PCV) and Assisted Pressure-Controlled (PACV) Ventilation; Synchronised Intermittent Mandatory Ventilation (SIMV); Pressure-Synchronized Intermittent Mandatory Ventilation (PSIMV); Pressure Support (PS.SV (PS)) and Pressure Support with Minimum Tidal Volume (PS.VT).

Sensitivity to patient effort (triggers) Sensitivity to the patient's inspiratory and expiratory effort is provided by inspiratory and expiratory triggers, which operate with both single and double circuits.

Ventilation monitoring Settings for ventilation trends are entered on the Elisée 150, and the ventilation data is then recovered and analysed by the EasyView™ 150 software program.

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Description

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Battery life The Elisée 150's internal battery allows it to operate for a significant period of time without a mains power connection. This time can be extended through the use of alternative power sources, which can be used simultaneously (external battery pack, ResMed Power Station, mains power pack and power supply from a car battery). The Elisée 150 can switch between power supplies without having to stop ventilation ("hot swap").

2.6 Accessories The following accessories are available for use with the ventilator: • Non-vented mask

• External batteries

• Patient circuit

• Remote control

• Single and double circuit supports

• Trolley

• Oxygen accessories: low-pressure oxygen sensor and oxygen coupling

• Remote alarm

• Antibacterial filter

• EasyView 150 trends analysis software

• Humidifier and water traps

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