Elisee 150 Patient Manual March 2009

Contents 1 Introduction... 1 1.1 Definitions 1.2 User/owner responsibility

1 1

2 Medical Information... 2 2.1 Purpose of the Elisée 150 2.2 Warnings

2 2

3 Description of the Elisée 150... 3 3.1 Components of the Elisée 150 3.2 Front of the Elisée 150 3.3 Touch screen 3.4 Connecting the circuit 3.5 On/Off button 3.6 Rear view

3 4 4 5 6 6

4 Connection Procedures... 7 4.1 Connecting the circuit 4.2 Electrical connection 4.3 Connecting an oxygen supply

7 9 11

5 How to use... 12 5.1 Starting up the ventilator 5.2 Starting ventilation 5.3 Stopping ventilation 5.4 Shutting down the device 5.5 Viewing ventilation settings and measurements 5.6 Charging the battery

12 12 13 14 15 15

6 Alarms and Troubleshooting... 16 7 Cleaning and Maintenance... 18 7.1 Maintenance of the dust filter 7.2 Maintenance of the exterior of the device 7.3 Maintenance of your circuit

19 19 19

8 Appendices... 20 8.1 Technical specifications 8.2 Description of buttons and symbols 8.3 Travelling with your device 8.4 Manual test (while ventilation is stopped)

20 20 22 22

Index... 25

iii

1 Introduction This manual is provided with your Elisée™ 150 ventilator (with software version 2.50 or higher). It is not a substitute for the clinical manual.

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

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WARNING Alerts you to possible injury.

!

CAUTION Explains special measures for the safe and effective use of the device. Note: Is an informative or helpful note.

1.2 User/owner responsibility The owner or user of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from: • operation which is not in accordance with the operating instructions supplied • maintenance or modifications carried out unless in accordance with authorised instructions and by authorised persons. Please read this manual carefully before use.

Introduction

1

2 Medical Information 2.1 Purpose of the Elisée 150 The Elisée 150 is a ventilator designed to be used by both adults and children, in the home or clinical environment. The ventilator is used with either a single or a double patient circuit.

2.2 Warnings This manual is provided with the device you have received. It does not in any way replace the clinical manual supplied to your physician or clinical care provider. • The advice contained in this manual does not replace the instructions given by your physician (or clinical care provider), who will already be familiar with the operation of the device through the clinical manual provided. • The device settings must be made by competent and trained staff under a doctor's supervision. • The ventilator must be used with the accessories recommended by the manufacturer or your prescribing physician. The use of inappropriate accessories is likely to affect the operation of the device. • In the case of externally visible faults, cease using the device. • In the event of functional problems (e.g. you find it difficult to breathe or trigger an inspiratory phase), do not hesitate to contact your clinical care provider. • Do not open the device casing. Repairs and internal servicing should only be performed by an authorised service agent. The above are general warnings. Other specific warnings and notes will be found throughout the manual. •

2

3 Description of the Elisée 150 3.1 Components of the Elisée 150 The picture below shows the set of components available from your clinical care provider: • Travel bag (1); • Elisée 150 ventilator (2); • Standard power cord (3); • Patient circuit (double circuit shown here) (4).

2

1

INT.

EXT.

3

4 Figure 1: Elisée 150 components.

Description of the Elisée 150

3

3.2 Front of the Elisée 150 The front has: • a touch screen (1); • an LED panel (2); • a retractable handle (3).

1

2

INT.

EXT.

3 Figure 2: Front view.

3.3 Touch screen You can use the buttons displayed on the device's touch screen to navigate through the menus of the Elisée 150. When you start up your Elisée 150, the start screen appears. The following information is displayed:

28 February 11: 28: 31

Wednesd.

Intern.

Mains

Ventilation program configured by your physician.

PS

START VENTIL

 1s

Figure 3: Start screen.

4

Type of electrical power supply.

Start ventilation button.

Note: See Section 8.2, “Description of buttons and symbols” on page 20 for more information on the various screens.

3.4 Connecting the circuit Your device will be fitted with a circuit support to connect a single or double circuit to, as prescribed by your physician.

Air outlet

Exhalation and proximal pressure line connections Figure 4: Single circuit support.

Air outlet

Exhalation circuit support with valve Figure 5: Double circuit support.

Description of the Elisée 150

5

3.5 On/Off button The On/Off button, along with several electrical connection ports, is on the right side of your Elisée 150.

12-28 V 15A max

On/Off button

Figure 6: Right side.

3.6 Rear view At the rear of the device you will see: • the oxygen connection (if prescribed by your physician); • the air inlet.

Air inlet Oxygen connection Figure 7: Rear view.

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6

WARNING • Do not block the air inlet, or the performance of your device may be compromised. • Use of oxygen can lead to a risk of explosion. Consult your clinical care provider on the necessary precautions.

4 Connection Procedures 4.1 Connecting the circuit Your system may be configured for either a single circuit or double circuit. For connection instructions, refer to the appropriate section for your air tubing configuration.

Connecting a single circuit 1. Connect the expiratory valve tube which has a connector on one end by pushing it firmly over the longer of the two pressure connectors on the device (a). 2. Then push the tube without a connector firmly onto the shorter pressure connector (b).

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CAUTION Take great care not to confuse the two tubes. 3. Then fasten the patient circuit firmly to the air outlet.

a

b

Depending on the type of patient circuit you are using, it may be necessary to cut off the connector on the end of the proximal pressure line

Figure 8: Connection of a single circuit.

Connection Procedures

7

Connecting a double circuit 1. Connect one limb of your double circuit to the air outlet. 2. Secure the other limb of your circuit to the other connector. Note: Other components in your patient circuit may include a humidification system, an antibacterial filter, a mask or cannulae, and water traps. Contact your clinical care provider if you have any concerns about connecting your patient circuit or accessories. Read the instructions provided with any accessories you are using (humidifier, filters, etc.).

Figure 9: Connection of a double circuit.

8

4.2 Electrical connection Your device may have one of two electrical connection configurations: • standard electrical connection; or • external electrical connection.

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CAUTION Be careful not to place the device where it could be knocked over or where someone may trip over the power cord.

Standard electrical connection If you are using the standard electrical connection located under your Elisée 150 (See Figure 11):

Figure 10: Standard power cord.

1. Insert one end of the cord into the connector underneath the device. 2. Push down the fastening clip on the connector. 3. Insert the mains plug into the power supply.

Figure 11: Standard mains power connection.

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CAUTION Remember to push down the fastening clip to hold the power cord in place. This will prevent accidental disconnection from the power supply.

Connection Procedures

9

External electrical connection If you are using an external electrical connection as shown below:

Figure 12: External electrical connection.

1. On the right side of the device, insert the cord into the connector in the 12-28 V socket marked “ 15A .” max 2. Insert the other end of the cord into a power outlet.

Figure 13: External mains power cable connection.

10

4.3 Connecting an oxygen supply Your Elisée 150 will be equipped with an oxygen connector should your prescribed treatment require oxygen. Connect the oxygen supply tube to the oxygen connector on the rear of the device.

!

CAUTION Ensure that the oxygen supply is switched off whenever oxygen is being connected or disconnected.

Oxygen supply

Figure 14: Connection of oxygen supply.

Connection Procedures

11

5 How to use 5.1 Starting up the ventilator After making all the required connections (patient circuit, accessories, tracheotomy tube or mask, electrical connections, etc.), press the On/Off button on the right-hand side of the device.

12-28 V 15A max

Figure 15: Switch the device on.

5.2 Starting ventilation When the ventilator starts up, the start screen is displayed. Press and hold the "START VENTIL" button for one second to start treatment. 28 February 11: 28: 31

Wednesd.

Intern.

Mains

PS

START VENTIL

 1s

INT.

EXT.

Figure 16: Starting ventilation.

12

Selecting a ventilation program Your physician may configure two different ventilation programs on your Elisée 150. To switch from one ventilation program to the other, simply press and hold the appropriate button. The selected program will turn black. cm

33.6 H2O

28 February 11: 28: 31 Intern.

Wednesd.

90 80 70

Secteur

60 50

P1:

ACV

P2:

PS

40 30 20 < Ai

10 0

< PE

INT.

EXT.

Figure 17: Selecting the ventilation mode.

5.3 Stopping ventilation 1. Press the On/Off button on the right-hand side of the device. 2. Press to stop ventilation.

cm

33.6 H2O Retour

90 80 70 60 50 40

Pause (stop ventilation)

30 20 < Ai

10 0

Stop machine

< PE

INT.

EXT.

Figure 18: Stopping ventilation.

How to use

13

5.4 Shutting down the device 1. Press the On/Off button on the right-hand side of the device. 2. Depending on whether or not your device is delivering ventilation: • During ventilation, press to turn off the ventilator: cm

33.6 H2O Back

90 80 70 60 50 40

Pause (stop ventilation)

30 20 < Ai

10 0

Stop machine

< PE

INT.

EXT.

Figure 19: Shutting down the device during ventilation. •

When ventilation is not being delivered, press YES to turn off the ventilator: Last test the 18/06/08 Double circuit : PASS

TEST

Do you want to switch off?

YES

NO

INT .

EXT.

Figure 20: Shutting down the device when ventilation is not being delivered.

14

5.5 Viewing ventilation settings and measurements To view the ventilation measurements and the settings programmed by your clinical care provider, press the ventilation program button. The following screen will appear: cm

26 H2O

Patient meter : 00000163H

VT 500 ml

90 80

PEEP cm 0 H 2O

70

F 15 bmp

60 50 40

I/E 1/2.0

Flowshape

1

Trigger 3

┘HP

30 20 10 < PE

0

PEEP VTI cm 4.2 H2O 501 ml

VTE 499 ml

Ppeak cm 25.1 H2O

Figure 21: A typical ventilation measurements and settings screen (while ventilation is being delivered).

5.6 Charging the battery The battery of your Elisée 150 charges whenever your mains power cord is connected (See Section 4.2, “Electrical connection” on page 9), whether or not the device is switched on. The table below explains the various battery LED displays. Table 1: Battery LED on the LED panel. Symbol and LED status

Meaning

Steady green light

Battery charged.

Green light, flashing slowly

Battery discharging.

Orange light, flashing slowly

Battery discharging (battery low).

Red light, flashing slowly

Battery discharging (battery flat).

Orange light, flashing rapidly

Battery charging interrupted (battery temperature too high or too low).

Green light, flashing rapidly

Battery charging.

How to use

15

6 Alarms and Troubleshooting The Elisée 150 is fitted with alarms to alert you to changes that will affect your treatment. Check that the patient circuit is correctly connected to your device. Some alarms can be deactivated temporarily (for 2 minutes) by pressing the button. The alarm will be reactivated if the problem persists.

!

CAUTION Service and repairs should only be performed by an authorised service agent. Do not attempt to service or repair the device yourself. Table 2: Alarm, cause and solution. Alarm icon

16

Cause

Solution

INT.

Internal battery power low.

Connect device to mains supply.

INT.

External battery power low.

Connect device to mains supply.

A component in your patient circuit is wrongly connected.

Check that your patient circuit is set up correctly as demonstrated by your clinical care provider, or replace it. Contact your clinical care provider if the alarm persists.

A technical fault has occurred in your device.

Contact your clinical care provider.

HP

A component in your patient circuit (tubing, mask, tracheotomy tube, etc.) may be blocked.

Clean, empty or replace the components of your patient circuit. Contact your clinical care provider if the alarm persists.

LP

A component in your patient circuit (tubing, mask, tracheotomy tube, etc.) may be wrongly connected.

Check that your patient circuit is set up correctly as demonstrated by your clinical care provider, or replace it. Contact your clinical care provider if the alarm persists.

Alarm icon

Cause

Solution

O2

A component in your oxygen circuit may be wrongly connected.

Check that the oxygen supply equipment is securely connected. Contact your clinical care provider if the alarm persists.

V

Your breathing has changed. OR A component in your patient circuit (tubing, mask, tracheotomy tube, etc.) may be wrongly connected.

Check that your patient circuit is set up correctly as demonstrated by your clinical care provider, or replace it. Contact your clinical care provider if the alarm persists.

F

Your breathing has changed. OR A component in your patient circuit (tubing, mask, tracheotomy tube, etc.) may be wrongly connected.

Check that your patient circuit is correctly set up as demonstrated by your clinical care provider, or replace it. Contact your clinical care provider if the alarm persists.

The power supply is disconnected.

If the disconnection is intentional, or due to a power outage, acknowledge by pressing the Alarm Silence button . Otherwise, reconnect the power supply. Contact your clinical care provider if the alarm LED remains lit.

Alarms and Troubleshooting

17

7 Cleaning and Maintenance Your clinical care provider will maintain your device and its accessories regularly. You should also maintain your device and accessories regularly as described below. Maintenance instructions for the various components are shown in this table. Table 3: Maintenance frequency.

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Component

Frequency

Patient circuit.

Weekly.

Exterior of device.

Weekly.

Dust filter (clean).

Monthly.

Dust filter (replace).

Every 6 months, or when worn or soiled.

CAUTION • For maintenance of the following accessories: mask, humidifier, antibacterial filter and water traps, refer to the manuals provided with these items. • Do not use bleach, chlorine, alcohol, aromatic-based solutions (including all scented oils), or moisturising or antibacterial soaps. These solutions may cause hardening and reduce the life of the product. WARNING Beware of electric shock. Do not immerse the device or power cord in water. Always unplug the device before cleaning and be sure that it is dry before plugging it back in.