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Pocket Guide
Evita XL
Software version 7.n
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
The user must be familiar with the device according to the national and local laws and recommendations.
There will be no exchange of the Pocket Guide when the product is updated/upgraded.
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2 Pocket Guide Evita XL
Contents
Contents
. . . . . . . . . . . . . . . . . . . . . . . . .
Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Front connections . . . . . . . . . . . . . . . . . . . . . . . . .
Back panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9
. . . . . . . . . . . . . . . . . . . .
Connecting to the power supply . . . . . . . . . . . . . .
Connecting to the gas supply . . . . . . . . . . . . . . . .
Installing expiratory valve, flow sensor . . . . . . . . .
9
Connecting the breathing circuit . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . .
11
Activating Standby mode . . . . . . . . . . . . . . . . . . . .
Entering the humidification type . . . . . . . . . . . . . .
Check readiness for operation. . . . . . . . . . . . . . . .
5
. . . . . . . . . . . . . . . . . . . . . . . .
33
Flow sensor calibration . . . . . . . . . . . . . . . . . . . . .
sensor calibration . . . . . . . . . . . . . . . . . . . . . . .
33
. . . . . . . . . . . . . . . . . .
34
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35
. . . . . . . . . . . . . . . . . . . . . . .
14
Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Main screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dialog windows and therapy controls . . . . . . . . . .
Controls and color scheme . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17
Selecting the patient . . . . . . . . . . . . . . . . . . . . . . .
Starting ventilation . . . . . . . . . . . . . . . . . . . . . . . . .
Setting the ventilation mode . . . . . . . . . . . . . . . . .
Setting the ventilation parameters . . . . . . . . . . . . .
Bronchial suctioning . . . . . . . . . . . . . . . . . . . . . . .
NIV – non-invasive ventilation
(SW 6.12 or higher) . . . . . . . . . . . . . . . . . . . . . . . .
Standby mode (SW 6.12 or higher) . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . .
23
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24
On-screen alarm messages . . . . . . . . . . . . . . . . .
Displaying alarm information . . . . . . . . . . . . . . . . .
Setting alarm limits . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . .
27
. . . . . . . . . . . . . . . . . . .
32
Displaying waveforms . . . . . . . . . . . . . . . . . . . . . .
Displaying the logbook . . . . . . . . . . . . . . . . . . . . .
Pocket Guide Evita XL 3
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4 Pocket Guide Evita XL
System Overview
System Overview
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Control panel
A
B
C
D
E
F
G
H
I
A Touch-sensitive screen
B Audio paused 2 min.
key for suppressing the alarm tone for two minutes
C
D
Alarm Limits key for setting alarm limits
Ventilator Settings key for setting ventilation mode and ventilation parameters
E Unassigned key for future functions
F Sensor Parameter key for calibrating sensors and for switching monitoring on or off
G 1
2
3 tions
System Setup key for configuring device func-
H Start/Standby key for switching between operation and Standby mode
I Rotary knob for selecting and confirming settings
Pocket Guide Evita XL 5
System Overview
Front connections
6
A B C D E
A Gas exhaust port
(EXHAUST – NOT FOR SPIROMETERS)
B Flow sensor
C Flow sensor flap (thermal cover)
D Expiratory valve with expiratory connector port
(GAS RETURN)
E Latch for expiratory valve
F Nebulizer connection
G Inspiratory connector port
(GAS OUTPUT)
H Locking screw for protective cover
(behind it: O 2 sensor)
F G H
Pocket Guide Evita XL
R
Q
P
O
Back panel
A B C D E F
System Overview
G
H
I
N
A Power switch with protective cover
B COM 2, COM 3 ports for RS 232, 2 CAN interfaces, and analog interface (optional)
C Connection for nurse call (optional)
D Connection for Remote Pad (optional)
E LAN connection for web application server of
SmartCare
F Cooling-air filter
G Option overview plate (not visible) on the right-hand side panel
H Connection
.
V for neonatal flow sensor (optional)
I ILV socket for the connecting cable for independent lung ventilation with two ventilators
J Connection for oxygen (O 2 )
K Connection for medical compressed air (AIR)
L Temp socket for temperature sensor (optional)
M L K J
M CO 2 socket for CO 2 sensor (optional)
N COM 1 RS 232C port for RS 232 interface, e. g., for monitoring system
O AC fuses
P Connector for power cable (AC)
Q DC socket
R Cooling fan
Pocket Guide Evita XL 7
8
System Overview
Trolley
A Evita XL
B Handle
C Trolley column
D Hose hook, 2x
E Humidifier holder (optional)
F Universal bracket with standard rail (optional)
G Dual castors with locking brakes, 4x
G
A
B
C
D
E
F
D
Pocket Guide Evita XL
Preparation
Preparation
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
How to start the
Evita XL
Preparing the Evita XL
– Connect the power supply
– Connect the gas supply (Air + O 2 )
– Install expiratory valve, flow sensor
– Connect the breathing circuit
– Switch on Evita XL
– Activate Standby mode
– Enter the humidification type
Checking readiness for operation
– Perform the Device Check
– Perform the Airtight Check
– Test the DC power pack (batteries)
Selecting patient and therapy settings
– Select the patient
– Set the ventilation parameters
– Set the alarm limits
Starting ventilation
– Touch start button in the Start/Standby dialog window
Connecting to the power supply
The mains voltage must correspond to the voltage range indicated on the rating plate.
Either: or:
220 V to 240 V
100 V to 127 V z Insert plug into the mains power socket.
For operation with DC power pack and external battery
(DC power pack option): z Connect optional external battery with cable.
Connecting to the gas supply
A
Air O 2
B
1 Screw on the compressed air hose (A) to the Air inlet connector and the compressed O 2 gas hose (B) to the O 2 inlet connector on the back panel of Evita XL .
2 Connect the plugs to the central gas supply wall terminal units.
Pocket Guide Evita XL 9
Preparation
Installing expiratory valve, flow sensor
Installing the expiratory valve
2 Place flow sensor (B) into its mount – with the connector facing towards the device – and push into the socket, as far as it will go.
3 Push flow sensor to the right and into the rubber lip seal of the expiratory valve, as far as it will go.
Connecting the breathing circuit
A
D
A
B
B
Evita XL
0.4m
1 Press down the segments on the right and left and tilt the control panel (A) upwards.
2 Push expiratory valve (B) into the mount until it clicks into position. Check that it is properly engaged by gently pulling on the port.
Mounting the flow sensor
1
A
Push connector socket (A) all the way to the left.
E
D
0.6m
1.1m
C
0.6m
B
1 Attach hinged arm (A) to the rail on the left-hand side of the ventilator and tighten screws.
2 Connect breathing hoses of appropriate lengths to the ports (B). Observe the required hose lengths (indicated in meters).
3 Install water traps (C) in vertical position.
4 Connect Y-piece (D), with the rubber sleeve of the
Y-piece on the inspiratory side.
5 Insert the Y-piece in the opening of the hinged arm
(E).
6 Connect test lung.
B
10 Pocket Guide Evita XL
Preparation
Switching on
Evita XL
A
Activating Standby mode
1 Touch Standby button within 30 seconds and press rotary knob to confirm.
The alarm message Standby activated !!!
is displayed in the header bar.
To acknowledge this message:
2 Touch Alarm Reset button to the right of the message and press rotary knob to confirm.
Evita XL is in Standby mode:
A
B
1 Press On/Off switch (A) until it engages.
The protective cover pivots down over the On/Off switch to protect against inadvertent switching off.
The Selftest screen with version no., date, and part no. of the software is now displayed.
The Selftest is performed automatically.
2 Wait for this test to be completed.
Evita XL then displays the "Start" screen.
Evita XL will start ventilation with the pre-configured settings unless values are changed or Standby mode is activated within 30 seconds.
Standby is displayed in the header bar of the screen
(A). Standby is displayed on the screen (B)
Pocket Guide Evita XL 11
Preparation
Entering the humidification type
B C
Check readiness for operation
A
Performing the Device Check
The Device Check can only be performed in Standby mode.
C
B
A
1 Touch the Humidifier tab (A).
Evita XL offers the following selections:
2
Active Humid.
(B)= Active breathing gas humidifier
HME/ Filter (C) = Heat and Moisture Exchanger
Touch button corresponding to the type of humidification used. The button turns yellow.
3 Press rotary knob to confirm. The button turns green.
Selecting the humidification type is only possible in
Standby mode.
1 Touch the Check tab (A).
Evita XL displays the date and result (B) of the last Device Check and Airtight Check.
2 Touch the Device Check tab (C).
E
D
Evita XL displays a list of the individual checks (D). The scope of this list depends on the options available on the ventilator.
No Device Check is possible while the ventilator is performing an automatic calibration of the flow sensor or O 2 sensor.
z In this case, wait until calibration is complete and restart Device Check.
12 Pocket Guide Evita XL
Preparation
Starting the Device Check
1 Touch the Check button (E).
Evita XL performs the following test steps:
System
– Fit and functionality of expiratory valve
– Fit of flow sensor
– Fit of neonatal flow sensor (optional)
– Type of humidification
– Completeness of breathing circuit
– Fit of temperature sensor (optional)
Function
– Test of the Air/O 2 switchover valve
– Test of the safety valve
– Gas supply
– Test of the back-up alarm (power failure alarm)
Sensors
– Calibration of the flow sensor
– Calibration of the neonatal flow sensor (optional)
– Calibration of the O 2 sensor
– Zero calibration of the CO 2 sensor (optional)
– Position of the CO 2 sensor (optional)
Performing the Airtight Check
The Airtight Check must be performed after the following actions:
– Device Check
– Change of the breathing circuit
– Change of breathing gas humidification
The Airtight Check can only be performed in Standby mode.
Prerequisite: The Start / Standby dialog window must be open.
1 Touch the Check tab (A).
2 Touch the Airtight Check tab (B).
C
3 Touch the Check button (C)
B
A
Device Check procedure
Evita XL guides the operator through each test step in a question-and-answer dialog format. Questions are displayed in the information field in the header bar and must be answered by touching the Yes or No buttons.
The instructions for performing the test steps are displayed.
Evita XL indicates a correct result with a checkmark
( ). Faulty results are marked with F .
Two dashes (- -) appear if a test step is not performed.
In the event of faulty results F :
1 Eliminate the cause of the problem.
2 Touch the Repeat button.
Test steps may be skipped by touching the Next test button if this is acceptable.
Testing the DC power pack (batteries)
Changeover test to battery operation
1 Pull out the power plug.
If the DC power pack is available, Evita XL switches over to internal or external battery mode and does not interrupt operation.
If the DC power pack is not available, the audible power failure alarm is triggered.
2 Plug in the power plug again.
The device switches to mains operation.
After successful checking of readiness for operation, Evita XL is ready for use.
Pocket Guide Evita XL 13
Operating Concept
Operating Concept
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Control panel
The control panel is characterized by a 15" touch screen, its clear layout and easy operation.
Its main elements are:
Main screen
A
F B
B
A
C
E D C
A Large screen with all the information and controls needed for ventilation.
B Fixed function keys beside the screen - for rapid access to major functions.
C Rotary knob for selecting and confirming settings on the screen.
A Header bar with the following fields:
– Alarms, messages, and instructions for the operator
– Therapy status: Therapy type (ventilation or O 2
Therapy), ventilation mode, and additional settings
– Patient category
B Main menu bar with buttons for opening dialog windows and activating functions
C Power supply display
D Field for device status with type of humidification
E Therapy bar with therapy controls for the ventilation parameters of the active ventilation mode and its additional settings
F Monitoring area with waveforms, loops, trends, and measured values
14 Pocket Guide Evita XL
Operating Concept
Main menu bar Therapy bar
The main menu bar contains fixed and freely configurable buttons. Touching a button opens the corresponding dialog window or activates the corresponding function.
Fixed buttons
1 2 3 , 1 2 3 , 1 2 3 for selecting a different set of measured values in the field for measured values.
Main for selecting the main screen.
Data ...
for displaying all measured values, the logbook, or trends on an additional card.
Special Procedure ...
for selecting additional functions, e. g., medication nebulization or oxygenation for bronchial suctioning.
The therapy bar on the main screen contains the therapy controls for the active ventilation mode.
A
A Therapy controls
Therapy controls
The therapy controls are used to set the ventilation parameters.
Therapy controls are contained in the therapy bar of the active ventilation mode and in the dialog window for specifying the ventilation settings.
Dialog windows and therapy controls
Dialog windows
A
Dialog windows consist of one or several pages which are displayed by touching the corresponding horizontal or vertical tab. Dialog windows contain elements for operating the device and inform the operator of current settings. Dialog windows can be opened by pressing a key or by touching a button in the main menu bar.
D
E
A
B C
D
A Dialog window title
B Button for accessing additional information (if applicable)
C Button for closing the dialog window
D Tab – touch the relevant tab to open a page
E Setting assistance field
A Therapy controls
Controls and color scheme
The following controls are available to the operator:
– Tabs
– Therapy controls
– Buttons
The touch-sensitive screen controls are used in a similar way as real keys and rotary knobs:
– Touching these controls with a fingertip is equivalent to pressing a key or taking hold of a knob.
– Settings are made and confirmed by turning and pressing the rotary knob.
Pocket Guide Evita XL 15
Operating Concept
Colors are used to indicate the status of the screen controls: gray = not available yellow = ready for use pale green = available, but is not active dark green = available and is active
For buttons:
1 2 4
3
1 to select = touch,
2 the button turns yellow,
3 to confirm = press rotary knob,
4 the button turns pale green or dark green.
For therapy controls:
1 2 5
3
4
1 to select = touch ,
2 the therapy control turns yellow,
3 to set = turn rotary knob,
4 to confirm = press rotary knob,
5 the therapy control turns pale green or dark green.
16 Pocket Guide Evita XL
Operation
Operation
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Selecting the patient
After switching on Evita XL , the operator can select between:
– Admitting a new patient
– Using the settings of the previous patient
Evita XL determines the tidal volume V T and respiratory rate f based on the ideal body weight and displays these values in the lower part of the dialog window (F). The other ventilation parameters displayed in the lower part of the dialog window are start-up values.
Using the settings of the previous patient
Admitting a new patient
For a new patient, Evita XL determines the start-up settings for the ventilation parameters based on the ideal body weight (factory setting) or based on the patient category. The settings can be configured. Only when a new patient is admitted, the body weight or the patient category can be changed.
Prerequisite: The Start / Standby dialog window must be open. Evita XL must be in Standby mode.
Specific patient settings in effect before Evita XL was switched off may be restored, including alarm limits, application mode, and ventilator status. Monitoring is always active after the ventilator has been switched on.
Prerequisite: The Start / Standby dialog window must be open. Evita XL must be in Standby mode.
A
A
B C D
E
F
1 Touch New Patient tab (A).
Depending on the patient category:
2 Touch Adult (B), Ped.
(C), or Neo.
(D) button.
3 Touch Ideal Body Weight button (E).
4 Turn rotary knob to enter the ideal body weight [kg], press rotary knob to confirm.
z Touch Previous Patient tab (A) and press rotary knob to confirm.
The previous ventilation settings are again effective.
Pocket Guide Evita XL 17
Operation
Starting ventilation
Before using on the patient z Check readiness for operation.
z Check therapy settings:
– For alarm limits.
– For ventilation modes and ventilation parameters.
In the Start / Standby dialog window:
A
The page of the active ventilation mode (A) with the
Basic settings (B) appears by default. The corresponding therapy controls (C) are displayed. The selected therapy control is yellow and can be set. With the
Add. settings tab (D), the active ventilation mode can be extended by additional parameters.
The following ventilation modes are factory-configured:
– SIMV
– CMV
– PCV+
– CPAP/ P Supp
Other ventilation modes (optional) can be selected via the more tab (E):
– MMV
– PCV+ Assist
– APRV
– PPS (optional)
The ventilation modes can also be supplemented with additional settings.
z Touch Start button (A) and press rotary knob to confirm.
Evita XL now starts ventilation.
Setting the ventilation mode
Changing the ventilation mode
Prerequisite: The Basic settings page must be open in the Ventilator Settings dialog window.
1 Touch the relevant tab, e. g., SIMV (A). The tab turns yellow.
Opening ventilation settings
A
The Ventilator Settings dialog window can be opened as follows: z Press Ventilator Settings key.
or z Touch a therapy control in the therapy bar.
Evita XL opens the Ventilator Settings dialog window.
A E
2 If necessary, set the ventilation parameters.
3 Confirm the ventilation mode by pressing the rotary knob. The color of the tab changes to dark green.
The ventilation mode is active. The settings are effective for the patient.
C
B
D
18 Pocket Guide Evita XL
Operation
Setting the ventilation parameters
Prerequisite: The Basic settings page must be open in the Ventilator Settings dialog window.
D E
C
B
A
1 Touch the relevant therapy control, e. g., (A).
2 Turn the rotary knob to set the value.
3 Press rotary knob to confirm.
Additional ventilation parameters derived from the ventilation parameter are calculated by Evita XL and displayed in the setting assistance field (B).
When the limit set for the parameter has been reached,
Evita XL displays a message.
3 Touch therapy control (C).
4 Set the value using the rotary knob and confirm.
To switch on an additional setting:
5 Touch (D) button and press rotary knob to confirm.
To switch off an additional setting:
6 Touch (E) button and press rotary knob to confirm.
The ventilation modes can be combined with additional settings to optimize ventilation.
Setting additional functions
Prerequisite: The Ventilator Settings dialog window must be open.
1 Touch Add. settings tab (A).
B
A
The additional settings of the active or selected ventilation mode are displayed.
2 Touch the tab for the relevant additional setting, e. g., (B).
The page for setting the associated parameter is displayed.
Pocket Guide Evita XL 19
Operation
Overview of the availability of additional settings
Ventilation mode
CMV
SIMV
MMV
ILV Master
ILV Slave
PCV+
PCV+ Assist
APRV
CPAP/ PSupp
PPS (optional)
ATC
(optional)
X
X
X
X
X
X
X
X
X
X
Apnea ventilation
X
Flowtrigger
Additional settings
Inspiratory termination
AutoFlow
X X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Sigh
X
X
X
PLV
X
X
X
X
X
Bronchial suctioning
Before suctioning
1 Touch Special Procedure ...
button in the main menu bar.
A
B
Preoxygenation lasts for a maximum of 180 seconds.
During this time, Evita XL waits for the disconnection necessary for suctioning. If no disconnection is detected within 180 seconds, Evita XL terminates the oxygenation procedure.
During suctioning
The time available for suctioning is displayed in seconds in the header bar. If suctioning is completed and the patient reconnected within the time available,
Evita XL will end the disconnection phase.
After suctioning
The Additional Function page (A) appears by default.
2 Touch O 2
↑
suction button (B).
3 Press rotary knob to confirm.
The oxygenation procedure is started.
Evita XL ventilates the patient in the set ventilation mode with the appropriately increased O 2 concentration.
The preoxygenation phase with the remaining time in seconds is displayed continuously in the header bar.
After reconnection, Evita XL resumes ventilation in the set ventilation mode. For postoxygenation, the O 2 concentration is increased for the first 120 seconds.
The postoxygenation phase with the remaining time in seconds is displayed in the header bar.
Canceling oxygenation
Touch O 2
↑
suction button.
20 Pocket Guide Evita XL
Operation
NIV – non-invasive ventilation
(SW 6.12 or higher)
Selecting NIV
The application mode can only be changed in Standby mode.
1 Touch Tube / Mask tab (A).
Starting ventilation with NIV
Prerequisite: The Start / Standby dialog window must be open.
A
B
A z Touch Start button (A) and press rotary knob to confirm.
2 Touch Mask (NIV) button (B).
3 Press rotary knob to confirm.
Evita XL displays the application mode in the header bar:
Mask Ventilation
Setting ventilation for NIV
z Set ventilation mode and ventilation parameters.
Monitoring during ventilation with NIV
In addition to the monitoring during ventilation in tube mode, certain new limits can be set in NIV.
The following alarm limits may be deactivated in order to avoid artifacts:
– MV , lower alarm limit for minute volume
– V Ti , upper alarm limit for inspiratory tidal volume
– T Apnea , upper alarm limit for apnea monitoring
If the lower alarm limit for minute volume or the upper alarm limit for apnea monitoring is switched off, Evita XL displays a permanent message in the header bar.
If the upper alarm limit for inspiratory tidal volume is switched off, Evita XL displays a message in the header bar for 15 seconds.
A time lag T deconnect between 0 and 60 seconds can be set for the alarm limit P AW (airway pressure low).
NIV Plus (optional) (SW 7.0 or higher)
The following functions are additionally available with the NIV Plus option:
– Standby Plus
– Flow reduction during disconnection
– Extended leakage compensation
Pocket Guide Evita XL 21
Operation
Standby Plus mode (SW 7.0 or higher)
If the device is switched from Mask Ventilation application mode to Standby, Evita XL switches to
Standby Plus.
In Standby Plus mode Evita XL starts ventilation as soon as it detects the first breath of the patient.
On-screen displays:
A
Standby mode (SW 6.12 or higher)
Switch to Standby mode or Standby Plus mode for the following actions:
– To keep Evita XL ready for operation while the patient is absent
– To switch between ventilation and O 2 Therapy
– To change application mode
– To change between patient categories
– To perform the Device Check and Airtight Check.
B
Selecting Standby mode z Press and hold the Start/Standby key for
3 seconds.
Evita XL is in Standby mode.
or z Press Start/Standby key.
Evita XL opens the Start / Standby dialog window.
Standby (A) is displayed in the header bar of the screen. Standby Plus (B) is also displayed on the screen.
When the mask is put back on, Evita XL detects the patient's inspiration and continues ventilation with the previous settings. The Mask Ventilation application mode is active again.
A
Flow reduction during disconnection
When the mask is removed, Evita XL reduces the inspiratory flow in the Adult and Ped.
patient categories. The function can be configured.
Extended leakage compensation
With the NIV Plus option, Evita XL performs leakage compensation during pressure-controlled ventilation in the
– Adult patient category, up to 180 L/min
–
–
Ped.
patient category, up to 60 L/min
Neo.
patient category, up to 30 L/min
1 Touch Standby button (A).
2 Press rotary knob to confirm.
B
3 Touch Alarm Reset button (B) in the header bar.
4 Press rotary knob to confirm.
Evita XL is in Standby mode or Standby Plus mode (only with NIV Plus option).
22 Pocket Guide Evita XL
On-screen displays:
D
C
Switching off
Evita XL
1 Switch Evita XL to Standby mode.
A
Operation
Standby (C) is displayed in the header bar of the screen. Standby or Standby Plus is displayed on the screen (D).
Resuming ventilation z Check ventilation settings (A).
2 Pivot protective cover upwards.
3 Press the On/Off switch (A) until it disengages.
Evita XL is switched off.
B
A
1 Touch Start button (B).
2 Press rotary knob to confirm.
The main screen is displayed, Evita XL starts ventilation.
or z Press Start/Standby key.
Evita XL starts ventilation.
Pocket Guide Evita XL 23
Alarms
Alarms
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
On-screen alarm messages
In the event of an alarm, the relevant alarm message appears in the alarm message field (A).
A
Alarm priorities
Evita XL assigns the alarm message its respective priority. It marks the text with exclamation marks and differently colored backgrounds. Evita XL generates the corresponding alarm tone sequences.
Warning High-priority alarm message
Low-priority alarm message
!!! Red background five-tone sequence which is sounded twice and repeated every 7 seconds
Caution Medium-priority alarm !!
Yellow background three-tone sequence which is repeated every message 20 seconds
Note !
Yellow background two-tone sequence which is sounded once
24 Pocket Guide Evita XL
Alarms
Displaying alarm information
A
Acknowledging alarm messages
Acknowledging high-priority alarm messages
A
D
B
C
1 Touch Alarm Info button (A).
All currently active alarm messages (B) are displayed.
2 Using the rotary knob, select the alarm message
(B).
3 Touch button (C).
The cause and remedy (D) of the alarm message are displayed.
z Remedy the fault.
The alarm tone ceases when the fault has been remedied. Medium- and low-priority alarm messages disappear automatically. High-priority alarm messages remain displayed in the color of the header bar and must be acknowledged.
z Touch the Alarm Reset button (A) in the header bar and confirm using the rotary knob.
Evita XL saves the alarm message, which can be displayed in the Data dialog window on the Logbook page.
Acknowledging Apnea ventilation !!
alarm message
The medium-priority alarm message (Caution)
Apnea ventilation !!
may be obscured by alarm messages of higher priority. The alarm message may therefore also be acknowledged with the Apnea Reset button.
B
1 Touch Alarm Info button.
2 Touch Apnea Reset button (B) and confirm using the rotary knob.
Evita XL continues to ventilate in the previously set ventilation mode.
Silencing audible alarms
The audible alarm can be silenced for a maximum of
2 minutes.
Pocket Guide Evita XL 25
Alarms
D
A
Setting alarm limits
z Press Alarm Limits key.
Evita XL opens the Limits page (A).
A
Evita XL
B
C
D
E
The set alarm limits and the current measured value are displayed.
z Press Audio paused 2 min.
(A) key.
The yellow LED in the key lights up.
The audible alarm will be silenced for 2 minutes.
B
The symbol (B) and the remaining time are displayed in the header bar.
If the fault that triggered the alarm is not remedied at the end of the 2 minutes, the audible alarm starts again.
If you wish to reactivate the audible alarm earlier: z Press Audio paused 2 min.
(A) key again.
Power failure alarm
If the loudspeaker for generating audible alarms fails due to a fault, a continuous tone will be generated by an auxiliary alarm.
The same continuous alarm tone also serves as a power supply alarm in the event of temporary interruption of power supply.
Connect Evita XL directly to another power supply or continue ventilation with an alternative system
(e. g., resuscitator).
(B) = Upper alarm limit
(C) = Currently measured value
(D) = Lower alarm limit
The values for the upper and lower alarm limit shown in the buttons are start-up values which are effective whenever the device is switched on.
Setting alarm limits
1 Touch the button for the respective alarm limit. The button will turn yellow.
2 Turn the rotary knob to set the value.
3 Press rotary knob to confirm. The button turns green.
The new alarm limit is effective.
Alarm limits for the optional measured value etCO 2 can be set on the Limits 2 page (E).
Deactivating alarm limits
1 Touch lower alarm limit (D).
2 Reduce value using rotary knob until a message is displayed in the header bar.
3 Press rotary knob to confirm.
4 Continue turning rotary knob until the value is replaced by dashes (--) in the display (D).
5 Press rotary knob to confirm.
The lower alarm limit is deactivated.
26 Pocket Guide Evita XL
Alarm messages
Alarm messages
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
The following alarm messages are an extract from all possible alarms only. For a complete list of alarm messages, refer to the Instructions for Use.
Message
Air supply down !!!
Airway obstructed ?!!!
Priority Cause
250 Air supply pressure too low.
230
Remedy
Make sure that supply pressure is greater than 43.5 psi (3 cmH 2 O).
Check condition of patient, check tube
Airway pressure high !!!
Airway pressure low !!!
205
204
The ventilator applies only a very small volume with each mechanical stroke, e. g. because the tube is blocked.
Patient 'fights' against the mechanical strokes in pressurecontrolled ventilation, with the result that the set inspiratory pressure is achieved with only a very small volume applied.
NeoFlow sensor not installed in the breathing system.
The upper alarm limit for the airway pressure has been exceeded. The patient is 'fighting' the ventilator or coughing.
Kinked patient circuit.
Leak or disconnection.
Check condition of patient, check ventilator settings.
Install NeoFlow sensor in the breathing system.
Check condition of patient. Check ventilation pattern. Adjust alarm limits if necessary.
Apnea !!!
Apnea ventilation !!
181
230
Patient´s spontaneous breathing has stopped.
Stenosis
Flow sensor not calibrated.
Due to detected apnea, the system has automatically switched over to mandatory ventilation.
Check patient circuit and tube.
Inflate cuff and check for leaks.
Check breathing circuit for tight connections. Check that the expiratory valve is properly engaged.
Check condition of patient, if necessary apply controlled ventilation.
Check condition of patient. Check tube. Check breathing circuit.
Calibrate flow sensor.
Check ventilation. Return to the original ventilation mode by touching the 'Apnea Reset' button and confirm. Check condition of patient. Check tube.
Pocket Guide Evita XL 27
Alarm messages
Message
Check settings !!
Device failure 00.00.000
!!!
Ext. battery activated !!!
FiO 2 low !!!
Priority
205
253
160
130
Cause
Malfunction while setting the ventilation pattern or the alarm limits.
The ventilation started with the configured initial values after switching on.
Device has detected a malfunction.
The ventilator is being powered by the external battery due to the absence of mains supply.
Only with fully charged batteries the device can be powered up to
120 minutes.
O 2 sensors not calibrated.
Faulty fresh-gas mixer function.
The ventilation function may be affected. This may lead to deviations in the O 2 concentration and tidal volume.
Remedy
Check ventilation pattern and alarm limits. The following settings are affected: O 2 concentration 'O 2 ', Alarm limit 'P AW high',
'MV low', status external flow source, status oxygenation for endotracheal suction key 'Alarm
Silence', button 'Alarm Reset', button 'Insp.hold', button
'Exp.hold', switch off O 2 monitoring, switch off flow monitoring.
Confirmation with rotary knob.
Confirm message with 'Alarm Reset' button.
Check parameters, patient values, and alarm settings and adjust them if necessary. Confirm message with 'Alarm Reset' button.
Switch 'off' and again 'on' the device. If the message disappears ventilation can be continued. If the message does not disappear, disconnect the patient from the device and continue ventilation immediately with another independent ventilator. Call
DrägerService.
Connect ventilator to the mains supply. Acknowledge the message with 'Alarm Reset' button and confirm.
Calibrate O 2 sensor.
Disconnect patient from the device and continue ventilation immediately with another independent ventilator. Call
DrägerService.
28 Pocket Guide Evita XL
Alarm messages
Message
Flow measurement out of range !!!
Int. battery activated !!!
Int. battery discharged !!!
Int. battery only 2 minutes left !!
Leakage !
Priority Cause
235 Water in flow sensor. Expiratory minute volume exceeds minute volume delivered by the ventilator.
160
Remedy
Dry flow sensor or change flow sensor and perform manual calibration.
Flow sensor not calibrated or faulty. Expiratory minute volume exceeds minute volume delivered by the ventilator.
Calibrate flow sensor, replace if necessary.
Flow measurement malfunction.
The ventilation function of the device is limited. Check patient condition, check ventilation. If not acceptable disconnect patient from the device and continue ventilation immediately with another independent ventilator. Call
DrägerService.
Due to the lack of power supply and absence of or discharged external battery the device is powered by the internal battery.
The maximum remaining time from the internal battery is
10 minutes.
Connect ventilator to the mains supply or to a fully charged external battery within 10 minutes.
Acknowledge the message with
'Alarm Reset' button and confirm.
254 Connect ventilator immediately to the mains supply or to a fully charged external battery.
250
009
Due to the lack of power supply and absence of or discharged external battery the device is powered by the internal battery.
The time for operation with power from the internal battery has expired.
Due to the lack of power supply and absence of or discharged external battery the device is powered by the internal battery.
The remaining operating time with power from the internal battery is less than 2 minutes.
The measured minute volume leak MV leak is 20 % higher than the minute volume measured on the exspiration side.
Connect ventilator to the mains supply or to a fully charged external battery within 2 minutes.
Check that the patient circuit connections are leakproof Check that the tube is correctly fitted.
Pocket Guide Evita XL 29
Alarm messages
Message
MV high !!!
MV low !!!
O 2 measurement out of range !!!
O 2 supply down !!!
PEEP high !!!
Pressure meas. error !!!
Priority Cause
160 The expired minute volume has exceeded the upper alarm limit.
160
132
249
216
170
Flow sensor not calibrated. Water in flow sensor.
The minute volume has fallen below the lower alarm limit.
Stenosis or obstruction Flow sensor not calibrated
Leakage or disconnection.
O sensor provides invalid measured values.
O
O
2
2
2
measurement malfunction.
supply pressure too low.
Expiratory system obstructed.
Expiratory resistance is increasing.
Ventilator faulty.
Fluid in expiratory valve.
Pressure measurement malfunction.
Remedy
Check condition of patient, check pattern of ventilation, adjust MV alarm limit if necessary.
Calibrate flow sensor. Drain water trap of breathing circuit. Dry flow sensor or replace.
Check condition of patient, check pattern of ventilation, adjust alarm limit if necessary.
Check condition of patient, check ventilation pattern, check tube or mask. Adjust alarm limit if necessary. Calibrate flow sensor.
Check breathing circuit for tight connections. Check whether the expiratory valve is properly engaged. Check whether tube or mask is fitted correctly.
Calibrate O 2 sensor, replace if necessary.
Ventilation can be continued: use external O 2 monitoring and deactivate integrated O 2 monitoring.
Call DrägerService.
Make sure supply pressure is greater than 43.5 psi (3 cmH 2 O).
Check hose system and exspiration valve (check also for condensate).
Check bacterial filter. Replace if necessary.
Disconnect patient from the device and continue ventilation without delay using another independent ventilator. Call
DrägerService.
Replace expiratory valve, then clean and dry.
Disconnect patient from the device and continue ventilation immediately with another independent ventilator. Call
DrägerService.
30 Pocket Guide Evita XL
Alarm messages
Message
Standby activated !!!
Tidal volume high !!!
Vol. not const., pressure limited !!
Priority Cause
255 Evita XL
Standby.
has been switched to
165 The upper alarm limit of the applied inspiratory tidal volume V Ti has been exceeded during three consecutive ventilator breaths.
Leak or disconnection.
220 Due to pressure limitation or time limit, the set tidal volume
V T has not been delivered.
Remedy
Acknowledge Standby with
'Alarm Reset' button and confirm.
Check condition of patient. Check pattern of ventilation. Adjust alarm limit if necessary.
Check that patient circuit and connections are leakproof.
Prolong inspiratory time 'T insp ', increase inspiratory flow 'Flow', increase pressure limitation 'P max .
Touch the 'Alarm Reset' button and confirm to suppress the visual and audible alarms until the cause of the alarm is remedied.
Pocket Guide Evita XL 31
Waveforms and logbook
Waveforms and logbook
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Displaying waveforms
The following real-time waveforms can be displayed:
– P AW (t)
– Flow (t)
– Volume (t)
– etCO 2 (t) (optional)
Selecting real-time waveforms
1 Touch Main button in the main menu bar.
Selecting other real-time waveforms
1 Touch Curve only tab (C).
2 Touch button for the parameter (D) to be displayed as a real-time waveform.
Evita XL displays the real-time waveform for this parameter. The dialog window is closed automatically.
In the same way it is possible to select:
– trends
– short trends
– recruitment trends
– loops
– big loops.
B
C
A
D
Displaying the logbook
A
2 Touch the relevant button (A).
Evita XL opens a dialog window, the Curves page (B) is selected by default.
1 Touch Data ...
button in the main menu bar.
2 Touch Logbook tab (A).
32 Pocket Guide Evita XL
Sensor calibration
Sensor calibration
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Flow sensor calibration O
2
sensor calibration
Flow sensor calibration is performed automatically at the following intervals:
– During device check
– Automatically, at least once a day
– After replacing the flow sensor
Evita XL cleans the flow sensor automatically before it is calibrated.
Evita XL also automatically cleans and calibrates the flow sensor after medication nebulization.
The flow sensor calibration can also be performed manually. The flow sensor may be calibrated during ventilation.
Starting manual calibration of the flow sensor
1 Press Sensor Parameter key.
The Flow page (A) appears by default. Flow monitoring is now switched on.
O 2 sensor calibration is performed at the following intervals:
– During device check
– Automatically, at least once a day
– After replacing the O 2 sensor (wait 15 minutes for the O 2 sensor to warm up)
– When measured and set values diverge by more than 2 Vol.%
The O 2 sensor calibration can also be performed manually. The O 2 sensor may be calibrated during ventilation.
Starting manual O 2 sensor calibration
1 Press Sensor Parameter key.
2 Touch O 2 tab (A).
A
B
A
B
2 Touch Start button (B).
Evita XL calibrates the flow sensor.
Evita XL uses the next inspiratory phase for calibration.
A message is displayed in the header bar.
3 Touch Start button (B).
Evita XL calibrates the O 2 sensor.
A message is displayed in the header bar.
The Start button (B) turns pale green when calibration is completed.
Pocket Guide Evita XL 33
Cleaning and disinfection
Cleaning and disinfection
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Components which can be reprocessed
Evita XL basic device
Trolley
Hinged arm
Gas supply hose
Breathing hoses
Y-piece
Water traps
Collection containers
Adapter parts for the medication nebulizer
Reusable expiratory valve and, if necessary, individual parts
Disposable expiratory valve
Spirolog flow sensor
SpiroLife flow sensor
Neonatal flow sensor insert
Neonatal flow sensor housing
Temperature sensor
CO 2 sensor
Reusable cuvette of the CO 2 sensor
Disposable cuvette of the CO 2 sensor
Test filter for CO 2 sensor
Breathing gas humidifier
Recommended reprocessing intervals after each patient after each patient after each patient/ weekly after each patient/ weekly daily daily daily daily daily daily daily
1)
Machine cleaning and disinfection no no yes yes no no no yes no no yes
Cleaning Disinfection outside outside possible possible outside outside outside possible outside outside possible
Manual outside outside possible possible
Dispose of after each patient/weekly yes yes yes
2) possible outside
3) outside 4) possible
Dispose of after each patient/weekly
Sterilization no no yes yes no yes yes yes yes no yes
Medication nebulizer
Bacterial filter daily after each patient/ weekly no outside
4)
In accordance with separate Instructions for Use outside
In accordance with separate Instructions for Use no
In accordance with separate Instructions for Use
1) Nebulizing may lead to formation of more extensive deposits requiring more frequent replacement.
2) Additionally treat the expiratory valve after disinfection.
3) Do not bath-disinfect.
4) Do not bath-disinfect. Wipe-disinfect, e. g., with 70 % ethanol.
34 Pocket Guide Evita XL
Accessories
Accessories
NOTE
The Evita XL Pocket Guide is not a replacement or substitute for the Instructions for Use.
Any use of the device requires full understanding and strict observation of the Instructions for Use.
Product Number Description
Spirolog 8403735 Flow sensor (set of 5)
SpiroLife
Expiration valve
MK01900 Flow sensor
8410580 Expiratory valve, autoclavable
Expiration valve 8414776 Disposable expiratory valve, (set of 10)
O 2 sensor (capsule) 6850645 Sensor for O 2 measurement
VentSet Basic MP00320 Disposable breathing circuit, 150 cm
VentSet Coax with holder MP00317
Disposable coaxial breathing system with Luer Lock elbow and hose holder
Filter/HME TwinStar ® 55 MP01805 Filter/HME combination
HME HumidStar
®
55 MP01730 Heat and moisture exchanger
ClassicStar ® , Size S
ClassicStar ® , Size M
ClassicStar ® , Size L
MP01573 Air cushion mask
MP01574 Air cushion mask
MP01575 Air cushion mask
Pocket Guide Evita XL 35
Accessories
Product
NovaStar
®
, Size S
NovaStar
®
, Size M
NovaStar
®
, Size L
Number
MP01579
MP01580
MP01581
Description
Gel mask, reusable
Gel mask, reusable
Gel mask, reusable
Aeroneb Pro Nebulizer MP01017 Nebulizer with electronic micropump
Cuvette adults, reusable
Cuvette, pediatric, reusable
Cuvette, adult, disposable
Cuvette, pediatric, disposable
6870279
6870280
MP01062
MP01063
Cuvette for CO
Cuvette for CO
Cuvette for CO
Cuvette for CO
2
2
2
2
measurement - adult, reusable
measurement - pediatric, reusable
measurement - adult, disposable
measurement - pediatric, disposable
36 Pocket Guide Evita XL
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Pocket Guide Evita XL 37
HEADQUARTERS
Dräger Medical AG & Co. KG
Starting 2010-09:
Dräger Medical GmbH
Moislinger Allee 53–55
23558 Lübeck, Germany www.draeger.com
REGION NORTH AMERICA
Draeger Medical, Inc.
3135 Quarry Road
Telford, PA 18969, USA
Tel +1 215 721 5400
Toll-free +1 800 437 2437
Fax +1 215 723 5936 [email protected]
Manufacturer:
Dräger Medical AG & Co. KG
Starting 2010-09:
Dräger Medical GmbH
23542 Lübeck, Germany
The quality management system at
Dräger Medical AG & Co. KG is certified according to ISO 13485, ISO 9001 and
Annex II.3 of Directive 93/42/EEC
(Medical devices).
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