Dräger Medical Evita 2 dura User manual

Evita 2 dura
Intensive Care Ventilator
Instructions for Use
Software 4.n
1-251-96
D
MEDICAL

Starting up
Switching on
Push in power switch on back panel until it clicks into
place = ON.
The flap comes down over the switch to prevent it
being inadvertently switched off.
Evita 2 dura runs a self-test.
Wait until the 10-second test phase is complete.
Evita 2 dura always begins ventilation with the start-up
values marked by an arrow on the on-screen knobs.
To select these start-up values, please refer to
pages 62 onwards.
After power cuts and after standby mode, the settings
valid immediately before the interruption of operation
remain in use.
Patient mode
After switching on, Evita 2 dura displays a choice of
patient modes:
–»Adults« = adult patients
–»Paed.« = children
–»Neo.« = neonates
(when using the "NeoFlow" option)
–»prev. patient« = previous patient
Example:
Adult ventilation
With this information, Evita 2 dura defines the adjustment
ranges and the start-up values of the ventilation
parameters.
The starting procedure, with selection of the patient
mode, can be configured by the user, see Configuration
on page 55 onwards.
22
Operation
Starting up
Working with these Instructions for Use
Header line – the title...
of the main chapter
The title of the specific sub-section is printed underneath
the main header – to help you find your way quickly from
subject to subject.
Page body...
the Instructions for Use
in combined text/illustrations. The information is
expressed in the form of practical actions, giving the user
direct hands-on experience in learning how to use the
machine.
Left-hand column...
the text
provides explanations and instructs the user step-by-step
in the practical use of the product, with short, clear
instructions in easy-to-follow sequence.
Bullet points indicate separate actions. Where several
actions are described, numbers are used both to refer to
the relevant details in the illustrations and to specify the
sequence of actions.
Right-hand column...
the illustrations
provide the visual reference for the text and make it easier
to locate the various parts of the equipment. Elements
mentioned in the text are highlighted. Unnecessary details
are avoided.
Screen displays prompt the user to proceed and confirm
correct actions.
Working with these Instructions for Use
2

What's new in Evita 2 dura
software 4.n
Specification of the humidifier used
– »Active humidifier«
or
– »HME/Filter« (artificial nose)
– for more accurate measurement of the volume
parameters
Apnoea ventilation On/Off
– can be selected as starting configuration
Extended range of settings for the
alarm time TApnoea >>
>>
– from 5 to 60 seconds
(formerly 15 to 60 seconds)
Ventilation mode BIPAPAssist
– for pressure-controlled assisted ventilation
Patient mode »prev. patient« can be selected
– to adopt the settings, including alarms, which were
effective before switching off the equipment
Leakage compensation On/Off
– for activation and deactivation of the automatic
leakage compensation function
Monitoring of tube blockages
– New alarm message »Tube blocked !!!«
Additional weaning parameters
available as software version 4.n plus upgrade
in addition to the parameter occlusion pressure P 0.1
Evita 2 dura 4.n also determines the parameters
– RSB Rapid Shallow Breathing index
and
– NIF Negative Inspiratory Force index
–fspn and MVspn as trend
External flow source
available as software version 4.n plus upgrade
– The amount of external flow is calculated by
Evita 2 dura 4.n (e.g. for additional tracheal gas
insufflation) and adjusts the volume monitoring
tolerances in order to avoid inadvertent alarms
Evita Remote (Remote Pad)
optionally available
– Remote control pad for parallel remote operation of
function keys on Evita 2 dura 4.n
NIV
optionally available
– Application mode to support non-invasive ventilation
therapies
Nurse call
optionally available
– Socket for connecting alarm signals to a central alarm
station in the hospital
Simplified settings
under "other modes"
3
What's new in Evita 2 dura software 4.n

4

For Your Safety and that of Your Patients.................................................9
Intended Medical Application.................................................................. 11
Operating Concept...................................................................................13
Ventilation Controls..................................................................................14
Setting ventilation parameters....................................................................14
Selecting the ventilation mode................................................................... 14
Screen Operating Controls...................................................................... 15
Keys for routine and additional functions....................................................15
Power switch............................................................................................ 16
Standby key »O«..................................................................................... 16
Screen Pages...........................................................................................17
Structure of the main page........................................................................ 17
Structure of the application-specific pages.................................................17
»Settings«..................................................................................................18
»Alarms«....................................................................................................18
»Measurements«........................................................................................18
»Calibration / Configuration«......................................................................19
Colour screen........................................................................................... 20
Operation................................................................................................. 21
Starting up............................................................................................... 22
Switching on............................................................................................. 22
Patient mode............................................................................................. 22
Selecting the patient mode........................................................................ 23
Starting ventilation..................................................................................... 24
Setting Ventilation Modes........................................................................25
IPPV..........................................................................................................27
SIMV, SIMV/ASB......................................................................................29
BIPAP, BIPAP/ASB.................................................................................. 31
BIPAPAssist................................................................................................32
CPAP, CPAP/ASB....................................................................................33
MMV, MMV/ASB...................................................................................... 34
Apnoea ventilation................................................................................... 36
Setting Alarm Limits.................................................................................37
In the Event of an Alarm.......................................................................... 38
Warning.................................................................................................... 38
Caution..................................................................................................... 38
Advisory.................................................................................................... 38
Suppressing the audible alarm...................................................................39
Information .......................................................................................... 39
5
Contents
Contents

Displaying Curves and Measured Values................................................ 40
In the main page........................................................................................40
Display measured values........................................................................... 41
Curve freezing...........................................................................................42
Special Functions.....................................................................................43
Manual inspiration......................................................................................43
Manual expiration hold............................................................................... 43
Medicament nebulisation........................................................................... 44
Oxygen enrichment for bronchial suction................................................... 47
Switching to Standby/Terminating standby mode.................................. 49
Calibrating................................................................................................50
Calibrating the O2sensor manually............................................................50
Calibrating the flow sensor manually..........................................................51
External flow source.................................................................................. 52
Switching off the monitor functions........................................................ 53
Configuration........................................................................................... 55
System Settings.......................................................................................56
Adjusting the volume of the audible alarm.................................................. 56
Setting the contrast................................................................................... 56
Country-specific settings......................................................................... 57
Selecting the language.............................................................................. 57
Setting the date and time...........................................................................57
Selecting measuring units..........................................................................57
Interface...................................................................................................58
Selecting the interface...............................................................................58
Screen......................................................................................................59
Selecting the displayed combination of measured values............................59
Selecting the displayed curves...................................................................61
Ventilation Defaults..................................................................................62
Patient-specific defaults.............................................................................62
Default ventilation parameter values........................................................... 63
Activating / deactivating pressure limit Pmax.............................................. 64
Apnoea ventilation on/off........................................................................... 65
Leakage compensation on/off....................................................................66
Default alarm limits.................................................................................... 67
Default ventilation mode.............................................................................69
6
Contents
Contents

Fault – Cause – Remedy.......................................................................... 71
Care..........................................................................................................79
Dismantling.............................................................................................. 80
Removing parts......................................................................................... 80
Disinfecting/Cleaning/Sterilising............................................................ 83
Disinfecting / cleaning / sterilising schedule............................................... 85
Assembling.............................................................................................. 86
Mounting the expiration valve..................................................................... 86
Inserting the expiration valve...................................................................... 86
Fitting the flow sensor............................................................................... 87
Fitting the O2sensor................................................................................. 87
Note on the use of heat and moisture exchangers...................................... 88
Note on the use of bacterial filters..............................................................88
For ventilating adults and children..............................................................89
For ventilating infants.................................................................................91
Supply and Connections..........................................................................92
Electrical power supply..............................................................................92
Gas supply................................................................................................93
Evita Remote (optional).............................................................................94
Connection................................................................................................94
Note automatic self-test............................................................................. 95
Nurse call (optional)..................................................................................96
Technical Data...........................................................................................96
Before Using for the First Time............................................................... 97
Device Check...........................................................................................97
Preparing the device check....................................................................... 97
Performing the device check......................................................................99
Device.....................................................................................................101
Leakproofing...........................................................................................103
Maintenance Intervals............................................................................107
Clean or replace cooling air filter............................................................. 107
Removing and reinserting ambient-air filter...............................................108
Correct disposal of batteries and O2sensors.......................................... 108
Correct disposal of apparatus................................................................. 108
Description.............................................................................................109
Ventilation Modes.................................................................................. 110
Volume-controlled ventilation with PLV.....................................................110
Sigh (intermittent PEEP)..........................................................................111
SIMV.......................................................................................................112
ASB........................................................................................................113
BIPAP.....................................................................................................114
7
Contents
Contents

BIPAPAssist............................................................................................. 115
MMV.......................................................................................................116
Flow measurement..................................................................................117
Automatic leakage compensation.............................................................119
Rapid Shallow Breathing RSB.................................................................121
Negative Inspiratory Force NIF................................................................ 121
Insp. O2concentration during
medicament nebulisation...................................................................... 122
Bibliography...........................................................................................123
What's what........................................................................................... 125
Control unit............................................................................................. 126
Front connection block for ventilation.......................................................127
Back panel..............................................................................................128
Abbreviations......................................................................................... 129
Symbols................................................................................................. 132
Technical Data....................................................................................... 133
Environmental conditions.........................................................................134
Settings.................................................................................................. 134
Performance data....................................................................................135
Measured value displays..........................................................................136
Monitoring...............................................................................................137
Operating data........................................................................................ 138
Parts List / Order List.............................................................................141
Parts List................................................................................................ 142
For adult ventilation ................................................................................ 142
For paediatric ventilation .........................................................................143
Order List............................................................................................... 144
Index...................................................................................................... 146
8
Contents
Contents

9
For Your Safety and that of Your
Patients
Strictly follow the Instructions for Use
Any use of the apparatus requires full understanding and
strict observation of these instructions. The apparatus is
only to be used for purposes specified here.
Maintenance
The apparatus must be inspected and serviced regularly
by trained service personnel at six monthly intervals.
Repair and general overhaul of the apparatus may only be
carried out by trained service personnel.
We recommend that a service contract be obtained with
DrägerService and that all repairs also be carried out by
them. Only authentic Dräger spare parts may be used for
maintenance.
Observe chapter "Maintenance Intervals".
Accessories
Do not use accessory parts other than those in the order
list.
Not for use in areas of explosion hazard
This apparatus is neither approved nor certified for use in
areas where combustible or explosive gas mixtures are
likely to occur.
Safe connection with other electrical equipment
Electrical connections to equipment which is not listed in
these Instructions for Use should only be made following
consultations with the respective manufacturers or an
expert.
Liability for proper function or damage
The liability for the proper function of the apparatus is
irrevocably transferred to the owner or operator to the
extent that the apparatus is serviced or repaired by
personnel not employed or authorised by DrägerService
or if the apparatus is used in a manner not conforming to
its intended use.
Dräger cannot be held responsible for damage caused
by non-compliance with the recommendations given
above. The warranty and liability provisions of the terms
of sale and delivery of Dräger are likewise not modified
by the recommendations given above.
Dräger Medical AG & Co. KGaA
For Your Safety and that of Your Patients

Safe use of the equipment
This equipment must only be used under the
supervision of qualified medical staff, so that help is
available immediately if any faults or malfunctions
occur.
This equipment must not be used with flammable
gases or anaesthetic agents. Danger of fire!
Do not use mobile telephones within 10 metres of
ventilators!
Mobile telephones may impair the functioning of
electromedical equipment and endanger the patient1).
Appropriate ventilation monitoring
The built-in monitoring facilities of Evita 2 dura ensure
appropriate monitoring of ventilation therapy and there-
fore detect any undesirable changes in the following
ventilation parameters:
– Airway pressure, Paw
– Expiratory minute volume, MV
– Inspiratory O2concentration, FiO2
– Inspiratory breathing gas temperature, T
– Expiratory CO2concentration, etCO2(optional)
– Inspiratory breathing volume, VTI
– Apnoea time
– Tachypnoea monitoring
Changes in these parameters may be caused by:
– Acute changes in the patient's condition
– Incorrect settings and faulty handling
– Equipment malfunctions
– Failure of power and gas supplies
If a fault occurs in this equipment, separate measuring
instruments should be used.
1) Dräger medical equipment meets the requirements for immunity to
interference in accordance with the specific product standards and
EN 60601-1-2 (IEC 601-1-2). Depending on the type of mobile
telephone used and on the application situation, however, field
strengths exceeding the values specified in the applicable standards
may develop in the immediate vicinity of the mobile telephone and
therefore lead to faults and malfunctions.
Back-up ventilation with an independent manual
ventilation device
If a fault is detected in Evita 2 dura so that its life-support
functions are no longer assured, ventilation using an
independent ventilation device must be started without
delay – if necessary with PEEP and/or increased
inspiratory O2concentration (e.g. with the
Dräger Resutator 2000).
10
For Your Safety and that of Your Patients
Safe use of the equipment

Contents
Intended Medical Application.................................................................. 12
11
Intended Medical Application
Contents
Intended Medical Application

Intended Medical Application
Evita 2 dura
Long-term ventilator for intensive care.
For adults, children and neonates.
With the following ventilation modes:
IPPV Intermittent Positive Pressure Ventilation
controlled and assisted constant-volume ventilation.
With the options:
–CPPV (Continuous Positive Pressure Ventilation)
–PLV (Pressure Limited Ventilation)
–AutoFlow* (optional)
for automatic regulation of inspiration flow
–IRV (Inversed Ratio Ventilation)
SIMV Synchronized Intermittent Mandatory Ventilation
Procedure for weaning patients off the ventilator after
they have started spontaneous breathing.
With the options:
–PLV (Pressure Limited Ventilation)
–AutoFlow(optional)
for automatic regulation of inspiration flow
MMV Mandatory Minute Volume Ventilation
Spontaneous breathing with automatic adjustment of
mandatory ventilation to the patient's minute volume
requirement.
With the options:
–PLV (Pressure Limited Ventilation)
–AutoFlow(optional)
for automatic regulation of inspiration flow
SB Spontaneous Breathing
Spontaneous breathing at ambient pressure
CPAP Continuous Positive Airway Pressure
Spontaneous breathing with positive airway pressure
ASB Assisted Spontaneous Breathing
Pressure-assisted spontaneous breathing
BIPAP* Biphasic Positive Airway Pressure
Pressure-controlled ventilation combined with free
spontaneous breathing during the complete breathing
cycle, and adjustable pressure increase to CPAP level.
–––––––––––
* Registered trade mark
BIPAPAssist (Biphasic Positive Airway Pressure Assisted)
Pressure-controlled assisted ventilation
APRV Airway Pressure Release Ventilation (optional)
Spontaneous breathing on two pressure levels with long
time ranges – independently adjustable.
Special modes:
Apnoea Ventilation
For switching over automatically to
volume-controlled mandatory ventilation, if breathing
stops.
If apnoea occurs, Evita 2 dura emits an alarm after the
preset alarm period (TApnoea >) and starts volume-
controlled ventilation.
ILV (optional)
Independent Lung Ventilation
Separate, differentiated, synchronised ventilation with
two Evita units, one for each lung.
Diagnostics
Intrinsic PEEP-measurement (optional)
for determining intrinsic PEEP and measuring trapped
volume.
Occlusion pressure measurement (optional)
for evaluating breathing drive during spontaneous
breathing.
With monitoring for
airway pressure, Paw
expiratory minute volume, MV
inspiratory O2concentration, FiO2
inspiratory breathing gas temperature, T
expiratory CO2 concentration, etCO2 (optional)
functional O2saturation and heart rate (optional)
inspiratory breathing volume, VTI
apnoea time
tachypnoea monitoring to detect rapid, shallow
spontaneous breathing
Automatic gas switch-over
In the event of a gas failure, the change-over to another
gas is automatic.
12
Intended Medical Application

Contents
Ventilation Controls................................................................................ 14
Setting ventilation parameters...................................................................14
Selecting the ventilation mode.................................................................. 14
Screen Operating Controls.....................................................................15
Keys for routine and additional functions...................................................15
Power switch........................................................................................... 16
Standby key »O«.................................................................................... 16
Screen Pages..........................................................................................17
Structure of the main page....................................................................... 17
Structure of the application-specific pages................................................17
»Settings«.................................................................................................18
»Alarms«...................................................................................................18
»Measurements«.......................................................................................18
»Calibration / Configuration«.....................................................................19
Colour screen......................................................................................... 20
Operating Concept
Contents
13
Operating Concept

Ventilation Controls
1Keys for selecting the ventilation modes:
–IPPV
–SIMV
–BIPAP
and
–other modes
2Keys for selecting / setting ventilation parameters:
– Tidal volume VT
– Inspiration time Tinsp
– Frequency f
– Inspiratory flow Flow
– Inspiratory pressure Pinsp
– Pressure-assisted spontaneous breathing ∆PASB
– Positive end-expiratory pressure PEEP
– Pressure rise time Ramp
–O2concentration O2
– Sensitivity Trigger
3Central "turn-and-push" rotary knob for setting the
parameters:
To set = turn the rotary knob
To confirm setting = press the rotary knob.
Setting ventilation parameters
2To set a ventilation parameter = press the
corresponding parameter key.
The yellow LED in the key lights up.
3To set the value of the ventilation parameter =
turn the rotary knob. The value is displayed next to the
parameter key.
3To confirm the value = press the rotary knob.
The yellow LED goes out.
Selecting the ventilation mode
1Hold down the appropriate key for about 3 seconds
or
press the appropriate key briefly and
confirm = press the rotary knob.
The selected ventilation mode will now be activated.
For detailed instructions on setting the ventilation modes,
see page 25.
D
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1
2Evita 2 dura
Operating Concept
Ventilation Controls
14

Screen Operating Controls
1Menu keys for selecting the menu on the screen.
2Central "turn-and-push" rotary knob for selecting and
setting the options displayed on the screen.
To select/set = turn the rotary knob
To confirm = press the rotary knob.
3Screen operating keys:
»Print « key for manual printer logging,
» « key for setting the screen brightness to
bright or dark,
»Freeze « key for freezing the curves,
»Curves « key for displaying a different pair of
curves,
»Values « key for displaying a different
combination of measured values,
one reserve key for future functions.
Keys for routine and additional functions
4Frequently used keys for routine functions are
positioned on the right-hand side of the front panel:
»g«key for suppressing the audible alarm tone,
»Alarm Reset« key for resetting or acknowledging
alarm messages,
»« key for calling up information and help on the
desired setting,
» « key for protecting against inadvertent or
unauthorised modification of the settings of the
ventilation parameters or ventilation modes.
5Keys for additional functions are positioned on the
left-hand side of the front panel:
» « key for switching the medicament nebuliser
on / off,
»O2 Suction«key for oxygen enrichment during
bronchial suction.
»Insp. hold« for manually activated inspiration,
»Exp. hold« for extending the expiration time,
one reserve key for future functions.
Operating Concept
Screen Operating Controls
15
1 2
3
1
2
DEvita 2 dura
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54
Evita 2 dura

Power switch
To switch the apparatus on / off.
Located on the back panel, with a covering flap to
protect the switch from being switched off inadvertently.
Standby key »O«
Placed on its own, away from other keys.
For keeping the apparatus on standby
or
for switching on ventilation.
To switch to standby:
●Press and hold down the »O« key for at least
3 seconds.
To switch on ventilation:
●Briefly press and release the »O« key.
Operating Concept
Power switch
Standby key » O «
16
DEvita 2 dura

Screen Pages
The screen pages consist of two basic structures:
– the main page, displaying all important ventilation
characteristics at a glance
and
– the application-specific pages for functions and
settings.
Important functions are displayed in the same position in
both structures:
– active ventilation mode and patient mode
– alarm, warning and advisory messages
– field for the menu selection keys
– information and help.
Structure of the main page
➀Line for the active ventilation mode, patient mode
and trigger indicator.
➁Bar for alarm, warning and advisory messages
➂Field for menu selection keys
➃Field for measured values
➄Field for curves
➅Bar for information and help
Structure of the application-specific pages
➀Bar for the currently active ventilation mode and
patient mode (example: BIPAP)
➁Field for displaying the selected menu
➂Field for the menu bar
➃Bar for the alarm, warning and advisory messages
➄Field for menu selection keys
➅Bar for information and help
➆Screen field, selectable with the rotary knob
➇Screen key, selectable with the rotary knob
➈Field for continuous pressure display and monitoring
17
Operating Concept
Screen Pages
➀ ➁
➅ ➄ ➃ ➂
➀ ➅ ➆ ➁
➄ ➇ ➈ ➂ ➃

The menu keys on the right-hand edge of the screen
select the screen pages for the following specific
application situations:
– Settings
– Alarms
– Measurements
– Measurement manoeuvre (optional)
– Calib./Config.
»Settings«
– For setting apnoea ventilation.
– For setting intermittent PEEP.
For detailed operating instructions, see "Setting
ventilation modes" on page 25 onwards.
»Alarms«
– For displaying the measured values with their alarm
limits.
– For setting the alarm limits.
For detailed operating instructions, see "Setting alarm
limits" on page 37.
»Measurements«
– For displaying all the measured values in the current
ventilation mode.
Press the »Table jj« screen key to display more option
measured values in »Table 2«.
Operating Concept
Screen Pages
18
DEvita 2 dura
001 37 253

»Calibration / Configuration«
Sensors
– Calibrating the sensors for O2and flow
– Switching the monitoring system on and off
Device
– Setting the volume of the acoustic alarm
– Setting the screen contrast
– Setting the date and time
– Selecting language and measurement units
– Setting the external interfaces
Display
– Selecting 2 x 6 measured values from the main page
– Selecting 2 x 2 curves from the main page
Ventilation
– Patient mode
– Ventilation mode
– Ventilation parameters
– Alarm limits.
19
Operating Concept
Screen Pages

Colour screen
For differentiating various items of information on the
screen.
For messages:
Red = Alarm
Yellow = Caution or advisory message
Blue = Alarm is no longer active
Example: "!!! Apnoea" alarm
For menu buttons:
Green = Can be selected
Black = Has been selected
Example: Menu button »Device ++«
For screen keys:
Green "LED" in the screen key = function not active
Yellow "LED" in the screen key = function active
Example: Screen key »Flow« – function active
Colour screen
20
002 37 253003 37 253004 37 253