Elisee 250 User Manual July 2007

SAFETY REQUIREMENTS The Elisée™ 250 is applicable for adult and paediatric patients. It is not designed for neonatal ventilation. This device is approved for continuous ventilation support. In an emergency situation and when using the device in barometric ventilation, do not leave the patient unsupervised. Do not operate the ventilator in the presence of flammable anaesthetics: it might result in fire or explosion. As the device uses the ambient air to function, it should not be used in an infected atmosphere (smoke, infectious agents). The device is not designed to be used on the scene of a fire. The user should take the necessary precautions to ensure the specified electromagnetic compatibility (EMC) limits are not exceeded. In particular, where the device is used in the presence of short waves or high frequency generators, such as defibrillators, diathermy, electrosurgery or radiology devices, cellphones, etc., interference may occur if the energy emitted is higher than the levels stipulated in Directive 93/42 EC. This device may be affected by interference from electromagnetic fields exceeding 10 V/m. The device is protected against water splash (IPX4) if the following conditions are respected: −

The device is used in its emergency and transport bag;

−

The mains supply pack is disconnected from the compartment under the device;

− The device runs on batteries. As the air inlet is situated at the back of the device, the latter should not be immersed. If the device is used in other configuration than those described above, it is not protected against water penetration (IPX0). It is the same for the mains supply pack. During transport, we recommend using the device in its security bag. The latter should be firmly fastened in the vehicle thanks to the loops designed for that purpose. Keep the device away from direct sunlight outside its emergency and transport bag. Do not expose the device to violent impacts outside its emergency and transport bag. Do not start the ventilator up immediately after storage or transport in conditions other than the recommended operating conditions. Do not cover the ventilator and place it so that its cooling system is not obstructed. Do not obstruct the openings of the ventilator. This equipment doesn't deliver a pressure lower than atmospheric pressure during the exhalation phase. The ventilator has been designed to avoid the inhalation of CO2 when the device stops: the rotary valve is closed so the expired gas runs through the exhalation valve instead of the inspiratory limb. The design of the ventilator and the properties of the turbine ensure that the maximum pressure supplied by the equipment cannot exceed 100 hPa (=101.6 cmH2O). We recommend disconnecting all oxygen inputs when the device is on standby mode or when it is turned off. Oxygen inputs must be connected after turning the ventilator on and be disconnected before turning the ventilator off. In case of turbine failure, the device can't be used even if a high pressure oxygen supply is connected. The electrical installation must comply with the local regulation standard. The device must be connected on the mains supply with the specific mains supply pack and the specific cable provided with the device. Any other connections may result in patient injury. If any doubts of electrical disruption on mains supply, the device must be used on the internal battery. We recommend connecting the device to the mains as soon as possible in order to recharge internal and / or external batteries in case of land, air or maritime intervention. To avoid personal injury and the risk of electric shock, as well as damages to the ventilator, do note operate the ventilator with its covers or panels removed. For any servicing, refer to technicians who have been trained to the ventilator maintenance.

Safety requirements

3

Check all audible and visual alarms regularly. Before connecting the ventilator to a patient, check all accessories to detect leakage risks and faulty elements. Do not use anti-static or electrically conductive hoses or tubing with the ventilator. Users must check that the total resistance of patient circuit does not exceed 6hPa (=6.096 cmH2O) for a 60 l/min flow (adult configuration) or 6 hPa (= 6.096 cmH2O) for a 30 l/min flow (paediatric configuration). The device and its user's manual have obtained the CE-marking (TÜV Rheinland, 0197). All used accessories must be certified CE. All electrical accessories must comply with electrical safety standard and electromagnetic compatibility standard (EN60601-1, EN60601-1-2). To obtain optimum electrical autonomy, perform a complete charge cycle for the built-in (and/or external) batteries before use. All faulty fuses from power supply or CPU board must be replaced by fuses with the same specifications. Decontamination and disinfection of the ventilator and its accessories must be carried out according to the manufacturer's instructions and according to the hospital protocol. Prior to the very first use of the ventilator or any use of the ventilator with a new patient, users must clean and disinfect accessories. If required, the manufacturer can give method used during production and delivery to ensure the cleanness of elements. Ventilation parameters settings must be fixed and carried out under the direction of a physician or qualified and trained staff. We recommend having a back-up ventilator or another way of ventilation. In accordance with directive 2002/96/EC concerning waste electrical and electronic equipment, this device must be sorted and disposed of separately. It must not be disposed of with municipal waste. To discard this device, you should use an appropriate waste collection system and the waste reuse and recycling systems in your area.

The serial number indicates the product code; EL2U, the year and the month of manufacturing, the number of the device in the month. Example:

EL2U 07 01 001 year

4

n° of the device in a month month

Safety requirements

SAFETY REQUIREMENTS... 3 I

II

INTRODUCTION ... 8

I.1

Field of application... 8

I.2

Main specifications of the ventilator... 8

I.3

Description of the ventilator panels ... 9

INSTALLATION ... 11

II.1

Supply ... 11

II.1.1 II.1.2

II.2

Power supply ... 11 Gas supply ... 14

Assembly of patient circuits and accessories... 15

II.2.1 II.2.2 II.2.3 II.2.4 III

Connection of "single patient circuit" or "double patient circuit" support ... 15 Connection of single patient circuit ... 16 Connection of double patient circuit... 17 Connection of accessories ... 17

CONFIGURATION OF ELISEE 250 ... 19

III.1

Standby mode ... 19

III.2

Turning the ventilator on ... 19

III.3

Using touch screen ... 19

III.4

Turning the ventilator off ... 20

III.5

Functional tests ... 20

III.5.1 III.5.2

III.6

Configuration of the Elisée 250... 25

III.6.1 III.6.2 III.6.3 III.6.4 III.6.5 III.6.6 III.6.7 IV

Manual test ... 21 Check of the electrical and pneumatic connection ... 24 Displays of ventilation selection (type, mode)... 25 Modification of ventilation mode... 26 Setting of ventilation parameters ... 26 Setting of the apnea ventilation parameters ... 27 Alarm thresholds setting ... 28 Starting and stopping the ventilation... 29 Check of the configuration ... 29

VENTILATOR SETTING ... 30

IV.1

Change of mode while ventilating ... 30

IV.2

Touch screen locking ... 31

IV.2.1 IV.2.2

Touch screen locking... 31 Touch screen unlocking... 31

IV.3

O2 100% ... 32

IV.4

Extended features ... 33

IV.4.1 IV.4.2

IV.5

Extended features menu... 33 Extended features options ... 34

Specific settings ... 35

IV.5.1 IV.5.2 IV.5.3 IV.5.4

Touch screen calibration... 35 Empty curves / full curves ... 35 Screen luminosity and screen orientation ... 36 Date/time... 38

5

V

VENTILATION MODES ... 39

V.1

Ventilation parameters definition ... 39

V.2

Ventilation modes... 41

V.2.1 V.2.2 V.2.3 VI

(Assisted) controlled ventilation ((A)CV or P(A)CV) ... 41 Spontaneous ventilation PS... 45 CPAP ventilation ... 47

ALARMS ... 48

VI.1

Alarms observation... 48

VI.2

Inhibition of audible alarms ... 48

VI.3

Presentation of ventilatory monitoring alarms... 49

VI.4

Alarm record in the black box... 51

VI.5

Reasons and corrective measures of ventilation alarms releases... 52

VI.5.1 VI.5.2 VI.5.3

VI.6

Presentation of maintenance alarms ... 55

VI.7

Presentation of technical alarms ... 55

VI.8

Alarms checking procedure... 58

VI.8.1 VI.8.2 VI.8.3 VI.8.4 VII

Test of mains supply or external DC supply alarms... 58 Test of setting alarms for a use with a single or a double circuit... 58 Test of setting alarms for a use with a double patient circuit ... 59 Test of setting alarms for a use with a single patient circuit ... 60

CLEANING AND DISINFECTION ... 62

VII.1

Recommended cleaning schedule ... 62

VII.2

Maintenance (methods for decontamination and cleaning) and replacement. ... 62

VII.2.1 VII.2.2 VII.2.3 VII.2.4 VII.2.5 VII.2.6 VIII

Patient circuit and exhalation valve ... 62 Humidifier... 63 Exterior surfaces of the ventilator ... 63 Anti-dust filter... 63 O2 CELL REPLACEMENT... 64 "Double circuit" support ... 66

TECHNICAL SPECIFICATIONS... 67

VIII.1 VIII.1.1 VIII.1.2 VIII.1.3

VIII.2 VIII.2.1 VIII.2.2 VIII.2.3 VIII.2.4

6

Unstoppable audible alarms ... 52 Temporarily stoppable audible alarms... 52 Stoppable audible alarms ... 54

Technical description and principles of operation ... 67 Technical description... 67 Functioning when using a single circuit ... 69 Functioning when using a double circuit... 70

Technical specifications... 71 Electrical specifications ... 71 Pneumatic specifications... 71 Specifications and performances ... 72 Operating, storage and transport conditions... 74

VIII.3

Accessories specifications... 75

VIII.4

Product compliance ... 76

IX

APPENDICES ... 77

IX.1

Accessories and spare parts... 77

IX.1.1 IX.1.2

IX.2

List of accessories... 77 List of spare parts... 77

Measures and parameters... 78

IX.2.1 IX.2.2 IX.2.3 IX.2.4

Interdependence of parameters... 78 Tacit parameters limits ... 79 Setting ranges, accuracies and default values ... 79 Symbols and abbreviations ... 82

7

I

INTRODUCTION

I.1 Field of application Elisée 250 is a dual mode ventilator. It combines barometric and volumetric ventilation. It can be used with invasive or non-invasive ventilation. The different possibilities of ventilation modes (controlled, assisted or pressure support) allow the ventilation of a wide range of adult and paediatric patients (with a tidal volume ≥ 50ml). The security and the autonomy of the device meet a continuous use on severe patients (dependent on ventilation). The device can be used in following situations: −

Mobile use for first aid to patients, in ICU or in recovery room

−

Mobile use during secondary transport such as transportation by road or by plane, and also during transport of patients under mechanical respiration in hospital.

−

Emergency use: resuscitation on the scene of an accident or a drowning. Do not use the ventilator in dangerous, explosive or biologically infected atmospheres.

−

Transport use: transport internally or outside the hospital, emergency situation, transport on long distances. The transport of the device is made easier thanks to the built-in handle on the ventilator or on security bag.

I.2 Main specifications of the ventilator Ventilation mode: ƒ

Assisted Controlled Ventilation ACV/PACV: barometric and volumetric.

ƒ

Mains supply : 100-230VAC, 50/60Hz, 0.6-1A

ƒ

Spontaneous ventilation : pressure support PS

ƒ

External supply : 12-28VDC,15 amps maxi

ƒ

CPAP ventilation

ƒ

Internal battery : Li-Ion ; 14.4 VDC ; 6.3 amp-hr

ƒ

External battery : Li-Ion ; 14.4 VDC ;6.3 amp-hr

ƒ

Consumption 75 VA.

ƒ

Class of device: Class II BF type.

ƒ

Oxygen: 240-700 kPa, 15 l/min maxi.

Trigger: auto-manual Parameters: ƒ

Frequency: 2 to 80 bpm.

ƒ

Tidal volume: 50 to 2,500 ml.

ƒ

Inspiratory Pressure: 3 to 60 cmH2O.

ƒ

Maxi flow: 5 to 120 l/min.

ƒ

PEEP : 0 to 25 hPa (=25.4 cmH2O)

ƒ

Flow shape: square or decreasing.

ƒ

FiO2: 21 to 100% (monitoring built-in).

ƒ

Backup Apnea Ventilation: programmable VCV/PCV.

ƒ

Key 100% O2 – 2min.

Display: ƒ

Built-in display: touch screen, electroluminescent, monochrome.

Oxygen consumption : In (A)CV mode, with Tv = 500 ml, PEEP = 7hPa, F = 15 bpm and I/E = 1/2.0 : ƒ FiO2 = 100 %, O2 consumption = 18 L/min +/- 20% ƒ FiO2 = 70 %, O2 consumption = 8 L/min +/20%

8

ƒ FiO2 = 60 %, O2 consumption = 6 L/min +/20% Power supply:

Introduction

Battery autonomy and recharging: Adult, PCV mode, P Insp. = 20 cmH2O, PEEP = 0 cmH2O, F = 15 bpm, Ti = 1.2 s, Trigger = NO, Slope = 3, BTPS = NO, MAQUET 190 test lung, patient circuit CIR009727, minimum screen brightness, Vte ≈ 425 mL, Altitude: 100 m, Temperature: 20°C): Internal battery: > 3 h; Battery + external battery pack: > 6 hrs. Recharging: the battery charging time is around 6 hrs per battery, with the device connected to mains power. (With an external power supplyof < 19 +/- 1 volts, the batteries do not recharge during ventilation.) Weight and size: ƒ

Size:

290 * 250 * 130 mm.

ƒ

Weight :

4.05 kg ventilator only 4.5 kg ventilator with mains supply pack 4,8 kg ventilator with external supply pack

I.3 Description of the ventilator panels

1 – Mains supply or external indicator light. 6

2 – Handle. 3 – Internal and external battery indicator: indicate the state of batteries charge.

1

4 – Silence alarm button. 5 – Luminosity sensor: automatically adjusts the contrast of the display. 6 – Touch screen: to set and visualize the parameters. 2

3

4

5

Figure 1: Top view of ventilator

7 – Connection of expiratory supports (double or single circuit).

7

8 – Insufflation outlet

.

8

Figure 2: Left view of ventilator

9 – External DC supply from 12V to 28V / 15 amps maxi. 10 – Push button on/off

.

11 – Serial connection socket: to connect to a PC.

9

10

11

Figure 3 : Right view of ventilator

Introduction

9

12 – Air outlet: do not obstruct. 12

13 – O2 high pressure connector (standardized EN739 connector). 15

14 – Air inlet. 15 – Access to O2 sensor.

13

14

Figure 4: Rear view of ventilator

17

16

16 – Manufacturer's name plate. 17 – Ventilator identification no. e.g. EL2U0701001 EL2U Elisée code

19

18

07

01

Year of Month of manufacture manufacture

001 Number in the month

18 – Location of the mains supply battery or the external supply battery. 19 – Item code PACXXX.

Figure 5: Underneath view of ventilator

10

Introduction

II

INSTALLATION

II.1 Supply II.1.1 Power supply The ventilator can work from 4 different power supplies. The device selects automatically the power supply according to the following priorities: 1: Mains alternating voltage: 100-230VAC / 50-60Hz / 0,6-1 amp (connection to the mains supply pack). 2: DC voltage coming from an external power supply: 12-28VDC / 15 amps maxi. 3: External battery (external battery pack installed). 4: Internal battery. In case of power cuts or if the mains supply cord is disconnected, an audible and visual alarm is released. It can be stopped by pressing the silence alarm button

. This alarm lasts maximum 15 seconds

Mains supply pack This pack enables the connection between the device and the mains supply.

! : The mains supply pack is not protected against water splash (IPX0). Therefore it should not be connected to the ventilator when there is a risk of water penetration. Assembly

! : Disconnect the mains supply before assembling.

Put both lugs in their compartment

Press firmly on the pack until the clip is locked

Disassembly

! : Disconnect the mains supply before assembling.

Installation 11

Connection

Connect the mains wire to the power port on the right side of the pack.

Fold down the retaining clip to avoid incidental disconnection of the cord.

L : The power supply is operative as soon as the device is connected to the mains supply. ! : When the ventilator is connected to the mains supply, turning the device off is impossible. The ventilator switches to standby mode to recharge the internal battery. To switch the ventilator off, disconnect the mains supply. This pack can be used outside its location. It is then connected to the device through an external supply cord. This assembly enables the device to work on the mains supply and to recharge the external battery.

! : When supplied with the external supply cord, the Elisée 250 manages this supply as an external supply, not as mains supply.

! : This configuration is recommended when using the device in emergency situation. A quick disconnection of the mains cord allows using the device outside the vehicle.

12

Installation

External DC power supply An external DC power supply (such as helicopter or car batteries from 12 to 28V – 15A max) can be connected by connecting the external power cord to the power port on the right side of the ventilator.

! : When the ventilator is connected to an external power supply, turning the ventilator off is impossible. The ventilator automatically switches to standby mode to recharge the internal battery (and the external battery if it is connected to the ventilator). To switch the ventilator off, disconnect the external power supply.

! : The external power supply ensures a charge of at least 1 hour. ! : If the external supply is lower than 19+/-1 V, then the recharge of the batteries is not made. External battery pack Refer to the assembling and disassembling instructions of the mains supply pack (see above) to assemble and disassemble the external battery pack. This kind of power supply takes priority on the internal battery supply.

! : The external battery pack should be disconnected when the device is switched off.

The external battery is recharged through the device when connected to the mains supply or to an external DC supply.

L : When the external battery charge drops below 5%, the Elisée 250 switches to the internal battery.

! : This configuration is recommended when using the External battery pack

device in emergency situation. A quick disconnection of the mains cord allows using the device outside the vehicle.

Mains supply pack Internal battery This battery stands inside the ventilator. When the ventilator is disconnected of either the mains supply or the external DC supply or the external battery, the device uses the internal battery. While the ventilator is plugged in (mains supply or external DC supply) upper than 19 +/- 1V, the internal battery is automatically charged.

L: When the charge level falls below 15%, the Low battery alarm is triggered. Within a minimum of 5 minutes, this alarm is followed by the Flat battery alarm (charge less than 5%) signalling that ventilation will stop. Once ventilation has stopped, the device will shut down completely within a minimum time period of 5 minutes. During this time, connecting the device to an external power source (other than the external battery) will immediately restart ventilation.

Installation 13

II.1.2 Gas supply Input of ambient air Ambient air enters the pneumatic circuit through an anti-dust filter.

!

! : Do not obstruct.

Input of ambient air

High pressure oxygen The Elisée 250 is equipped with an input of high pressure oxygen (pressure from 240 kPa up to 400 kPa). Oxygen can be delivered through an oxygen bottle equipped with a pressure reducer.

L It is advisable to set the pressure reducer at 400 kPa with a margin of 50 kPa. The Elisée 250 automatically manages the FiO2 following the instructions users have set.

! : Flexible hoses must comply with EN739 standard specifications. ! : The oxygen should be connected only once the ventilation has started. Disconnect the oxygen before stopping the ventilation.

Oxygen consumption The theoretical consumption of oxygen is displayed at the bottom right of the graphs screen.

Oxygen consumption

14

Installation

II.2 Assembly of patient circuits and accessories Elisée 250 allows users to connect a single or a double patient circuit thanks to its interchangeable exhalation valve control. Elisée 250 is a ventilator for adults and children ventilation. It is not designed for neonatal ventilation and should not be used with circuits having 10 mm in diameter. The user may use the following types of circuits: −

15 mm in diameter for ventilation with a tidal volume between 50 and 300 ml;

−

22 mm in diameter for ventilation with a tidal volume > 300 ml.

! : Elisée 250 automatically detects the type and characteristics of the patient circuit (single or double circuit) during the manual test. A manual test should then be done after changing the circuit.

II.2.1 Connection of "single patient circuit" or "double patient circuit" support There are two supports:

"Single circuit" support allows connecting the exhalation valve control connector and the proximal pressure line.

Air outlet : do not obstruct

"Double circuit" support allows connecting the exhalation limb.

Each support is to be directly connected to the port on the left side of the ventilator. Assembly and disassembly:

Locating points

Clips To remove the support: press on the clips and pull the support. To install the support: position correctly the centre points and press on the support until the clips are locked.

! : Check those center points fit in

Installation 15

II.2.2 Connection of single patient circuit EXHALATION VALVE

Exhalation Valve

PRESSURE

Proximal pressure line



PATIENT

To obtain an efficient working, we recommend the use of Intersurgical circuit or equivalent. To assembly the proximal pressure line (Intersurgical reference: CIR011563), cut the nozzle.

L : Proximal pressure line must be placed as near as possible from the patient. Proximal pressure measure improves insufflation pressure monitoring and pressure trigger sensitivity.

8 If users connect a HME filter, proximal pressure line must be installed between the patient and the filter. 8 Use of a dual-limb circuit is recommended for ventilation-dependent patients. 8 We recommend setting a Vti alarm threshold of 10 - 15% of delivered volume. Patient circuit installation Check the device is equipped with a single patient circuit support (otherwise, change the circuit). Connect the exhalation valve control nozzle. Push it and turn it of a quarter on the right. Connect the proximal pressure line by fitting the hose onto the notched tip. Connect the inspiratory limb to the insufflation outlet

Exhalation valve control

16

Proximal pressure line

.

Inspiratory limb of the patient circuit (Ø 22mm standard)

Installation

II.2.3 Connection of double patient circuit

L : Any circuit, with or without water trap, reusable or single use, complying with the specifications of the recommended circuit can be used with the Elisée 250.

Check that the Elisée 250 is equipped with its "double circuit" support (otherwise, change it). Connect the exhalation limb to the input of exhalation gas

Connect the inspiratory limb to the insufflation output

.

8 We recommend setting a Vte alarm threshold based on measured expiratory volumes. Exhalation limb of the patient circuit (Ø 22mm standard)

Inspiratory limb of the patient circuit (Ø 22mm standard)

II.2.4 Connection of accessories

! : Do not forget to do a manual test after any change in the patient circuit. Filters Bacterial or and "heat and moisture exchanging" filters can be connected to the Y-coupler, to the exhalation input or to the insufflation output.

L : It is advisable to connect a bacterial filter to the insufflation input or a HME filter between the Y-coupler and the patient.

! : Assemble these filters in compliance with the manufacturer’s recommendations. Active humidifier system

A humidifier ("Fisher and Paykel" of "MR850" type or equivalent) can be connected to the device in order to improve air humidity. Electrical connection is done according to the manufacturer’s directions.

! : Assemble the humidifier in compliance with the manufacturer’s directions.

Humidifier

Installation 17

Emergency and transport bag

During transport, we recommend using the device in its emergency and transport bag (non-contractual picture). The latter should be firmly fastened in the vehicle thanks to the loops designed for that purpose.

Loops The opposite configuration is recommended when using the device in emergency situation. A quick disconnection of the mains cord allows using the device outside the vehicle.

! : In emergency situation, the mains pack should be disconnected from the trap situated under the device.

18

Installation

III

CONFIGURATION OF ELISEE 250

III.1 Standby mode When the device is switched off but connected to mains power, a screen showing the battery charge level will appear. After 60 seconds the standby screen will appear. Touch the screen or press the Alarm Mute button to display the Battery charge level screen again.

« Indicator screen of the battery »

« Standby mode »

III.2 Turning the ventilator on

Press the button

III.3

on the right side of the ventilator.

Using touch screen

Press the corresponding icons on the screen to reach display screens and select parameters.

Configuration of Elisée 250 19

III.4 Turning the ventilator off Press the button on the right side of the ventilator. The following display appears: To turn the ventilator off, press the icon indication "stop machine".

next to the

L : By safety measure, users have to press the icon for more than 3 seconds to turn the ventilator off. The message "STOP IN PROGRESS" is displayed and the ventilator turns off. A beep alarm releases. Users can stop it by pressing the silence button .

L : When the ventilator is connected to the mains supply or the external supply, it doesn't turn off but switches to standby mode to recharge batteries.

L : In case of touch screen failure: −

Disconnect the mains supply;

−

Press the button

−

Maintain pressure on the buttons until the ventilator stops (10 seconds).

on the right side of the ventilator and the silence alarm button

simultaneously;

III.5 Functional tests All of these tests must be carried out after turning the ventilator on or after any change or modification in the patient circuit. They consist of: −

A manual test;

−

A check of the electrical connection;

−

A check of the pneumatic connection.

The following section describes these tests.

20

Configuration of Elisée 250

III.5.1 Manual test This test must be carried out when turning the ventilator on or after any change or modification in the patient circuit. To do the test, turn the device on. The welcome screen is displayed.

Press this frame in order to display the test. By safety measure, a minimum 3-second pressure is required.

Back to the welcome screen

The result of the last test appears. Users can either return to the welcome screen or redo a test by pressing “RESTART TEST”.

To start a new test

To cancel the test in progress

Follow the instructions: disconnect the patient circuit and its accessories. As soon as users press “CONTINUE”, the ventilator measures the sensors offsets.

To go ahead

Configuration of Elisée 250 21