evita_4_and_evita_instructions_for_use_sw_4-n_2nd_e.pdf
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Instructions for Use
Evita 4 / Evita 4 edition
WARNING
For a full understanding of the
performance characteristics of this
device, the user should carefully read
this manual before use of the device.
Intensive Care Ventilator
Software 4.n
Page 2
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.
Calibrating
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.
The last calibration/zeroing values remain stored until the next
calibration/zero calibration, even when the machine is
switched off.
Calibration of the pressure sensors for measuring the airway
pressure is automatic.
The flow sensor and O2 sensor are automatically calibrated
once per day.
Manual calibration of the flow sensor can be performed at any
time, even during ventilation.
Manual calibration of the O2 sensor can be performed at any
time, even during ventilation. The applied O2 concentration is
not affected by calibration.
The calibration of the CO2 sensor can be checked during ventilation.
Start calibration:
z Press »Calibration« key.
Display (example):
z Touch the »O2« screen key.
The LED in the screen key changes colour to yellow.
Message in the help line at the bottom of the screen:
»O2-calibration«
After calibration is complete, the yellow LED in the screen
key goes out.
134
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.
Calibrating the O2 sensor
– Before operation, during the device check.
– After replacing the O2 sensor (wait for the 15 minute
warmup time of the O2 sensor).
– If the measured value and set value deviate from each
other by more than 2 Vol%.
The O2 sensor can be calibrated during ventilation.
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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109
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
site_109
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.
z Bullet points indicate the steps to be followed,
1 Where several steps are described, the numbers refer to
the illustration. Numbering starts from 1 again on each new
page,
– Dashes indicate lists of data, options or objects.
Operation
Page 3
Trademarks
Registered trademarks
– AutoFlow®
Trademarks used under licence
– BIPAP*
Definitions
WARNING
A WARNING statement provides important information
about a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
A CAUTION statement provides important information about
a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or in
damage to the equipment or other property.
NOTE
A NOTE provides additional information intended to avoid
inconvenience during operation.
Abbreviations and Symbols
Please refer to "Abbreviations" on page 193 and "Symbols" on
page 195 for explanations.
*
Licensed trademark
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Evita 4 edition
The Evita 4 edition is identical to the Evita 4. Both devices
have identical components, options and functionalities. This
refers to all electrical, electronic and pneumatic components
as well as to the trolley, the installed software and the available
options.
The terms "Evita 4" and "Evita 4 edition" are used
synonymously in these Instructions for Use.
What's new in Evita 4 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)
Frequency can be reduced to 0
– for BIPAP and SIMV, for weaning without transitions
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
Additional weaning parameters
available as software version 4.n plus upgrade
in addition to the parameter occlusion pressure P 0.1
Evita 4 4.n also determines the parameters
– RSB Rapid Shallow Breathing index
and
– NIF Negative Inspiratory Force index
External flow source
available as software version 4.n plus upgrade
– The amount of external flow is calculated by Evita 4 4.n
(e. g. for additional tracheal gas insufflation) and adjusts
the volume monitoring tolerances in order to avoid inadvertent alarms
Extended use of loop presentations
available as software version 4.n plus upgrade
– Loops can be zoomed and frozen
– Loops can be displayed permanently in the upper part of
the screen
Evita Remote (Remote Pad)
optionally available
– Remote control pad for parallel remote operation of function keys on Evita 4
NIV
optionally available
– Application mode to support non-invasive ventilation therapies
Nurse call
optionally available
– Connection for transmitting alarm signals to a central hospital alarm station
Leakage compensation On/Off
– for activation and deactivation of the automatic leakage
compensation function
Extended logbook entries
– Evita 4 4.n identifies alarms which are active but not displayed with an asterisk
Monitoring of tube blockages
– new alarm message »Tube blocked !!!«
*
4
Please refer to page 200 onwards for new features in software
versions 2.n and 3.n
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Contents
Contents
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
For Your Safety and that of Your Patients . . . . . . . . . . . . . 7
Dismantling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Disinfecting/Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Care list for the Evita 4 intensive care ventilator . . . . . . . . 155
Assembling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Before Reusing on Patient. . . . . . . . . . . . . . . . . . . . . . . . . 157
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Clean Covering Grid for Heating Patient Part . . . . . . . . . . 159
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
General WARNINGS and CAUTIONS. . . . . . . . . . . . . . . . .10
Intended Medical Application . . . . . . . . . . . . . . . . . . . . . . 13
Operating Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Structure of the Control Unit . . . . . . . . . . . . . . . . . . . . . . . . 18
The Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
On-Screen Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Screen Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Control Unit Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Information on Preparation . . . . . . . . . . . . . . . . . . . . . . . . .32
Preparing the EvitaMobil Trolley . . . . . . . . . . . . . . . . . . . . . 32
Positioning the Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . 33
Fitting the Device Components . . . . . . . . . . . . . . . . . . . . . .35
Using HME, Bacterial Filters and Hose Systems. . . . . . . . . 38
Ventilating Adults and Children . . . . . . . . . . . . . . . . . . . . . .39
Ventilating Infants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Connecting to Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Connecting Evita Remote (optional) . . . . . . . . . . . . . . . . . .45
Connecting the Nurse Call (optional). . . . . . . . . . . . . . . . . .47
Before Using for the First Time . . . . . . . . . . . . . . . . . . . . . .49
Device Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Transportation within the hospital . . . . . . . . . . . . . . . . . . . . 58
Switching piped gas supply to cylinder supply. . . . . . . . . . .58
No Instrument Tray (optional) . . . . . . . . . . . . . . . . . . . . . . . 59
Cleaning, Disinfection, and Sterilisation . . . . . . . . . . . . 149
What is what. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Weaning Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Insp. O2 Concentration During Medication Nebulisation . . 192
Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
What was new in Evita 4 software 2.n . . . . . . . . . . . . . . 200
What was new in Evita 4 software 3.n . . . . . . . . . . . . . . 201
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Starting up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Patient Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Starting Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Setting Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . . . .65
ILV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Apnoea Ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Setting Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
In the Event of an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Displaying Curves and Measured Values . . . . . . . . . . . . . . 90
Displaying Measured Values . . . . . . . . . . . . . . . . . . . . . . . .91
Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Loops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Screen Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Special Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Switching off monitor functions . . . . . . . . . . . . . . . . . . . . .106
Selecting Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Calibrating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
System Defaults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use . . . . . . . . . . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . . . . . . . . . . .
Safe connection with other electrical equipment . . . . . . . .
Safe networking of computers . . . . . . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Functional safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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General WARNINGS and CAUTIONS . . . . . . . . . . . . . . 10
Note on EMC/ESD risk for the device function . . . . . . . . . 10
Appropriate ventilation monitoring . . . . . . . . . . . . . . . . . . 11
Back-up ventilation with an independent manual
ventilation device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
WARNING
Strictly follow these Instructions for Use.
Any use of the product requires full understanding and
strict observation of all portions of these instructions.
The device is only to be used for the purpose specified
under "Intended Use" from page 13 and in conjunction
with appropriate patient monitoring (see page 9).
Observe all WARNING and CAUTION statements
throughout this manual and all statements on device
labels.
Maintenance
WARNING
The device must be inspected and serviced regularly by
trained service personnel. Repair of the device may also
only be carried out by trained service personnel.
Dräger recommends that a service contract be obtained
with DrägerService and that all repairs also be carried
out by them. Dräger recommends that only authentic
Dräger repair parts be used for maintenance. Otherwise
the correct functioning of the device may be compromised.
See chapter "Maintenance".
8
Accessories
WARNING
Only the accessories indicated on the list of accessories
for Evita 90 38 780 (1st edition or higher) have been
tested and approved to be used with the device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific device.
Otherwise the correct functioning of the device may be
compromised.
Not for use in areas of explosion hazard
WARNING
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
WARNING
Electrical connections to equipment which is not listed
in these Instructions for Use should only be made following consultation with the respective manufacturers.
Safe networking of computers
When networking with electrical devices, the operator is
responsible for ensuring that the resulting system meets the
requirements set forth by the following standards:
– EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility;
Requirements and tests
– EN 60601-1-4 (IEC 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Follow associated installation and operating instructions.
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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For Your Safety and that of Your Patients
Patient safety
The design of the equipment, the accompanying literature,
and the labelling on the equipment take into consideration that
the purchase and use of the equipment are restricted to
trained professionals, and that certain inherent characteristics
of the equipment are known to the trained operator.
Instructions, warnings, and caution statements are limited,
therefore, largely to the specifics of the Dräger design.
This publication excludes references to various hazards which
are obvious to a medical professional and operator of this
equipment, to the consequences of product misuse, and to
potentially adverse effects in patients with abnormal conditions. Product modification or misuse can be dangerous.
Patient monitoring
The operators of the system must recognise their responsibility for choosing appropriate safety monitoring that supplies
adequate information on equipment performance and patient
condition.
Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and patient condition to simple, direct
observation of clinical signs.
The responsibility for the selection of the best level of patient
monitoring lies solely with the equipment operator.
Functional safety
The essential performance consists in controlled and monitored patient ventilation with user-defined settings for the monitoring functions
– minimum breathing gas flow,
– maximum airway pressure,
– minimum and maximum oxygen concentration in the
breathing gas,
or, if a set limit is exceeded, by an appropriate alarm. The
device is equipped with basic safety features to reduce the
possibility of patient injury while the cause of an alarm is
remedied.
Dräger Medical GmbH
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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For Your Safety and that of Your Patients
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to general
operation of the device. WARNINGS and CAUTIONS specific
to subsystems or particular features appear with those topics
in later sections of the manual.
WARNING
Use the device under the supervision of qualified medical personnel only to ensure that any malfunction is
remedied without delay.
WARNING
This equipment must not be used with flammable gases
or anaesthetic agents. Danger of fire!
WARNING
Do not use the device in hyperbaric chambers!
Device operation may be affected, thus placing the
patient at risk.
WARNING
The equipment must not be used for nuclear resonance
tomography (MRT, NMR, NMI)!
This may impair correct functioning of the equipment
and endanger the patient.
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibility (EMC)
pursuant to international EMC standard IEC 60601-1-2
Electromedical devices are subject to special precautionary
measures concerning electromagnetic compatibility (EMC)
and must be installed and put into operation in accordance
with the EMC information included in the technical documentation which is available from DrägerService on request.
Portable and mobile RF communications equipment can affect
medical electrical equipment.
WARNING
Connector pins with an ESD warning sign
should not be touched and no connections
should be made between these connectors
without implementing ESD protective measures. Such precautionary procedures may include antistatic clothing and shoes, the touch of a ground stud
before and during connecting the pins or the use of electrically isolating and antistatic gloves. All staff involved
in the above shall receive instruction in these ESD precautionary procedures.
WARNING
Do not place any liquid container (e. g. infusion container) above or on top of the Evita 4.
Any liquid getting into the device could prevent Evita 4
from working properly or damage it, and endanger the
patient.
WARNING
Medications and other substances based on inflammable solvents, such as alcohol, must not be used in the
patient system. Adequate ventilation must be ensured
when using inflammable substances for disinfection.
Flammable vapours may ignite during calibration of the
flow sensor and destroy the sensor. Fire hazard!
NOTE
The risk of a software error endangering the patient can be
minimized as follows:
A software development process is applied that conforms
with the state-of-the-art technology and international standards for medical products.
10
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
Page 11
For Your Safety and that of Your Patients
Appropriate ventilation monitoring
The built-in monitoring facilities of Evita 4 ensure appropriate
monitoring of ventilation therapy and therefore detect any
undesirable changes in the following ventilation parameters:
– Airway pressure, Paw
– Expiratory minute volume, MV
– Inspiratory O2 concentration, FiO2
– Inspiratory breathing gas temperature, T
– Expiratory CO2 concentration, 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.
Back-up ventilation with an independent manual ventilation device
If a fault is detected in Evita 4 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 O2 concentration
(e. g. with manual breathing bag MR 100)
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Intended Medical Application
Intended Medical Application
Scope of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
With the following ventilation modes . . . . . . . . . . . . . . . . .
Supplements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostic functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DC power supply unit (optional) . . . . . . . . . . . . . . . . . . . .
Evita 4 Link (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MEDIBUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Automatic gas switch-over . . . . . . . . . . . . . . . . . . . . . . . .
Areas of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Intended Medical Application
Scope of Application
Evita 4 – long-term ventilator for intensive care.
For adults, children and neonates.
For premature babies with the "NeoFlow" option.
With the following ventilation modes
IPPV (Intermittent Positive Pressure Ventilation)
Volume-controlled ventilation with fixed mandatory minute
volume.
With the options:
– CPPV (Continuous Positive Pressure Ventilation)
Controlled ventilation with continuous positive airway
pressure
– PLV (Pressure Limited Ventilation)
Pressure limited constant-volume ventilation
– AutoFlow®
for automatic regulation of "Insp. Flow" and "Pinsp"
– IRV (Inversed Ratio Ventilation)
Ventilation with inversed inspiration/expiration ratio.
SIMV (Synchronized Intermittent Mandatory Ventilation)
Combines mechanical (volume-controlled) ventilation with
spontaneous breathing.
With the options:
– PLV (Pressure Limited Ventilation)
Pressure limited constant-volume ventilation
– AutoFlow®
for automatic regulation of "Insp. Flow" and "Pinsp".
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)
Pressure limited constant-volume ventilation
– AutoFlow®
for automatic regulation of "Insp. Flow" and "Pinsp".
BIPAP (Biphasic Positive Airway Pressure)
Pressure-controlled ventilation combined with free
spontaneous breathing during the complete breathing cycle
and adjustable pressure assist on CPAP level.
BIPAPAssist (Biphasic Positive Airway Pressure Assisted)
Pressure-controlled assisted ventilation.
APRV (Airway Pressure Release Ventilation)
Spontaneous breathing on two pressure levels with long time
ranges – independently adjustable.
PPS (Proportional Pressure Support) (optional)
For differentiated proportional support of spontaneous
breathing with pathological compliance and/or resistance.
ILV (Independent Lung Ventilation)
Separate, differentiated, synchronised ventilation with two
Evita units, independently ventilating each lung.
Supplements
Automatic Tube Compensation ATC (optional)
Can be used for all ventilation modes.
Compensates the tube resistance.
Apnoea ventilation
For switching over automatically to volume-controlled
mandatory ventilation, if breathing stops.
If apnoea occurs, Evita 4 emits an alarm after the preset alarm
« and starts volume-controlled ventilation.
period »TApnoea
NIV mask ventilation (optional)
Non-invasive ventilation
For ventilation with a nasal or facial mask to support noninvasive ventilation of patients with spontaneous breathing.
Choice available between mask ventilation and ventilation of
intubated patients.
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.
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Instructions for Use Evita 4 / Evita 4 edition SW 4.n
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Intended Medical Application
Diagnostic functions
Intrinsic PEEP measurement
For determining intrinsic PEEP when air trapping occurs.
Occlusion pressure measurement
For evaluating breathing drive during spontaneous breathing.
Negative Inspiratory Force NIF (optional)
For measuring the patient's maximum inspiratory effort
following expiration.
Monitoring
Airway pressure Paw
Expiratory minute volume MV
Inspiratory tidal volume VTi
Inspiratory O2 concentration FiO2
Inspiratory breathing gas temperature T
Apnoea time
Tachypnoea
Expiratory CO2 concentration etCO2 (optional)
DC power supply unit (optional)
Integrated DC power supply unit, supplying Evita 4 with power
from two DC sources:
– Two internal 12 V lead-gel batteries in the DC power
supply unit
and
– optionally via additional external 12 V or 24 V lead-gel
batteries.
MEDIBUS
Software protocol for the transfer of data between Evita 4 and
an external medical or non-medical device (e. g. patient
monitors or computers for data management systems) via an
RS 232 port, see "MEDIBUS for Dräger Intensive Care
Devices" (90 28 329).
WARNING
All transferred data are for information only and should
not be used as basis for diagnostic or therapeutic decisions. Danger to the patient cannot be excluded.
To protect the patient and the user against electrical hazards,
it is essential that all systems consisting of medical devices as
well as other electrical devices which are not restricted to
computers, printers etc., are only assembled by trained
personnel.
The system must meet the requirements of the
IEC/EN 60601-1-1 and IEC/EN 60601-1-2 standards.
Automatic gas switch-over
In the event of a gas failure, the unit automatically changes
over to the other gas supply available.
Areas of use
In the intensive care ward or in the recovery room and with the
optional DC power supply unit when transporting ventilated
patients within the hospital.
For uninterrupted operation following failure of the mains
power supply, by automatically switching over to the external
or internal battery.
For supplying power from the internal batteries or additionally
from external batteries during in-house transport.
Evita 4 Link (optional)
Interface card
For output of measured values, status messages and alarm
messages to on-line equipment for monitoring, documentation
or processing.
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
15
Page 16
16
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
Page 17
Operating Concept
Operating Concept
Structure of the Control Unit . . . . . . . . . . . . . . . . . . . . . 18
The Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
On-Screen Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Screen Keys for Selecting Functions without
Confirmation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Screen Keys for Function Selection, Adjustment and
Confirmation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Screen Knobs for Setting Parameters . . . . . . . . . . . . . . . 22
Screen Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Standard Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen Page »Mode settings« . . . . . . . . . . . . . . . . . . . . .
»Alarm limits« Screen Page . . . . . . . . . . . . . . . . . . . . . . .
»Values measured« Screen Page . . . . . . . . . . . . . . . . . .
Display Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
»Special procedure« Screen Page . . . . . . . . . . . . . . . . . .
»Calibration« Screen Page . . . . . . . . . . . . . . . . . . . . . . . .
»Configuration« Screen Page . . . . . . . . . . . . . . . . . . . . . .
24
24
26
27
27
28
28
29
Control Unit Location . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
17
Page 18
Operating Concept
Structure of the Control Unit
The main components of the control unit are the screen, a set
of fixed function, keys and the central rotary dial-knob.
The function keys are used to call up the screen pages appropriate to the application.
Evita 4
Evita 4
214
NOTE
Do not cover the black plastic frame around the screen and
do not place any objects in the frame.
The touch-sensitive screen keys and knobs will no longer
function correctly.
001
In addition to curves, measured values and status displays,
the screen contains, in a separate field, touch-sensitive keys
and touch-sensitive rotary knobs for parameter setting.
The touch-sensitive screen keys and the screen knobs are
used in a similar way to ordinary keys and knobs:
Touching with the fingertip is equivalent to pressing a key or
taking hold of a knob.
The display always contains only the screen keys and screen
knobs required for function selection and/or adjustment.
Settings and confirmations are made by turning and pressing
the central, rotary knob.
The keys for routine functions are placed to the right and left
on the outside of the front panel.
Frequently used function keys are placed on the right, e. g. the
key » « for selecting the standard page or the
»Alarm Reset« key for resetting or confirming messages.
Evita 4
002
Less frequently used function keys are placed on the left-hand
side of the front panel, e. g. the key »
« for switching the
medication nebuliser on/off, or the »O2 Suction« key for
bronchial suctioning.
18
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
Page 19
Operating Concept
The Power Switch
004
003
for switching the device on/off.
The power switch is located on the back panel and has a pivoting cover to protect against being inadvertently switched off.
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
19
Page 20
Operating Concept
On-Screen Controls
Touching these controls with the fingertip is equivalent to
pressing key or taking hold of a knob.
The colour displays the status of the "control" and "LEDs":
green
= usable
white
= not usable
yellow
= adjust/confirm
black
= effective function/display
Screen Keys for Selecting Functions without
Confirmation
e. g. for paging through the system on-screen
for changing the menu
for switching over displays.
IPPV
Assist
A
m
Paw [mbar]
60
40
21
Ppeak
33 > 50
Pplat
27
20
0
-10
MV
0
2
21
4
.500
O2 [%]
6
1.7
VT
8
t [s]
21
Tinsp
f
1
2
3
FiO2
5.3 _
7.0
4.0
Basic
settings
IPPV
Extra
settings
BIPAP
SIMV
60
5
Flow
PEEP
ASB
005
The lower half of the screen contains touch-sensitive coloured
screen keys and screen knobs.
IPPV
60
Assist
A
m
Paw [mbar]
40
21
Ppeak
33 > 50
Pplat
27
20
0
-10
MV
0
MV
2
4
6
f
11:06 total 1.5
spon 0.0
8
t [s]
11:06 total 1.5
spon 0.0
1
2
3
FiO2
5.3 _ 7.0
4.0
Zoom in
Table
Zoom out
Trends
40
20
20
10
Loops
0
12:03 11:03
12:03
Logbook
006
0
11:03
Example:
z Press the »Table« key = select display.
The key goes black to show that the function is active.
Table
007
Table
20
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
Page 21
Operating Concept
Screen Keys for Function Selection, Adjustment and
Confirmation
Display (example):
IPPV
60
A
m
Paw [mbar]
40
21
Ppeak
33 > 50
Pplat
27
20
0
-10
7.0
5.3 _ 4.0
MV
0
MV
2
5.3
4
L/min 4.0
6
_
7.0
fspn
0.0
bpm
_
30
VTi
.497
L
_
780
_
50
33
L/min
t [s]
TApnoea
etCO2
s
––
mmHg
0
_
15
_
100
Limits
Monitoring
Logbook
008
Paw
8
1
2
3
FiO2
1
Touch the relevant screen key for the alarm limits, e. g.:
MV 2.3 L/min »
«
The colour changes from green to yellow = setting function
is set.
Turn the rotary knob = adjust the alarm limit. The value is
displayed in the screen key.
Press the rotary knob = the colour changes from yellow to
green, and the set alarm limit is confirmed and effective.
1
9.3
3.1
3
To cancel the setting:
z Touch the screen key again
or
z touch another screen key.
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
2.3 L/min
2
3
200
2
MV
21
Page 22
Operating Concept
Screen Knobs for Setting Parameters
Display (example):
IPPV
60
Assist
A
m
Paw [mbar]
40
21
Ppeak
33 > 50
Pplat
27
20
0
-10
MV
0
2
21
.500
VT
6
1.7
Tinsp
8
t [s]
21
f
60
5
Flow
PEEP
5.3 _
7.0
4.0
Basic
settings
IPPV
Extra
settings
BIPAP
SIMV
ASB
005
O2 [%]
4
1
2
3
FiO2
e. g. »PEEP« screen knob.
Touch the »PEEP« screen knob:
1 It changes colour from green to yellow = setting function
selected.
2 Turn rotary knob = Adjust setting. The value is displayed in
the knob.
3 Press rotary knob = Confirm. The knob changes colour
from yellow to green, and the setting is validated and takes
effect.
1
5
PEEP
PEEP [mbar]
2
While pressure values, such as Pmax, are being set, they are
displayed in the Paw (t) curve as a dashed black line.
10
PEEP [mbar]
009
3
To cancel the setting:
z Press the screen knob again
or
z press another screen knob.
22
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
Page 23
Operating Concept
Screen Pages
All the screen pages have the same structure, i.e. their contents are always arranged in the same positions on the screen:
Messages indicating ventilation modes and alarms, displays
of measured values and curves, and help functions, always
appear in the same position on the screen:
2
3
4
5
6
The active ventilation mode/patient mode is displayed
on the left-hand side of the top line.
The ventilation mode is indicated by its abbreviation, e. g.
BIPAP.
The patient mode is indicated by a symbol:
A
for adults,
P
for paediatric.
In the case of spontaneous breathing activity by the
patient, a lung symbol
is briefly displayed as indicator.
Curves are displayed in the upper left-hand quarter of the
screen.
The lower half of the screen shows curves and measured
values or screen keys and screen knobs – depending
which screen page is selected.
Alarms are displayed on the right of the top line.
Measured values are displayed in the upper right-hand
quarter of the screen.
Help functions appear in the bottom line of the screen. On
the right, Evita 4 provides setting instructions. On the left,
Evita 4 provides information on the current status – this
information can be accessed by pressing key » «.
5
2 Curves
Measured
values
3 Curves or screen knobs
Measured
values or
screen keys
6 Help functions
Evita 4
011
The solid function keys to the right of the screen are used to
select the screen pages for the following specific application
situations:
– Mode settings
– Alarm limits
– Values measured
– Special procedure
– Calibration
– Configuration
1 Current ventilation mode/patient mode 4 Alarms
010
1
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
23
Page 24
Operating Concept
Standard Page
For displaying the ventilation status
z Press » « key.
Display (example):
The standard page shows the ventilation situation at a glance
– reduced to the most important measurement parameters
and curves.
Four measured values are shown on the right, and two curves
on the left.
Other measured values and curves can be selected in the
standard page and all subsequent screen pages.
012
To select other measured value combinations:
z Touch screen key » « repeatedly.
To select other curves:
z Touch key » « and touch the screen key corresponding
to the desired curve.
Screen Page »Mode settings«
For displaying the setting parameters
The bottom right-hand side of the screen contains the screen
keys for selecting the ventilation modes.
The screen key displayed in black (IPPV in the example) represents the currently activated ventilation mode.
The bottom left-hand side of the screen contains the onscreen rotary control knobs.
The values of the setting parameters are displayed in the
screen knobs relevant to the ventilation mode.
The user-definable start-up settings are marked by an
arrow ( ) on the scales of the screen knobs. See "Configuration" on page 123 onwards.
24
013
Changing the settings of an active ventilation mode
z Touch the appropriate screen knob, which will change
colour from green to yellow = setting function enabled.
z Turn the rotary knob on the control unit = adjustment of the
value of setting in the screen knob.
z Press the rotary knob: the screen knob changes colour
from green to yellow = the setting is confirmed (validated)
and active.
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
Page 25
Operating Concept
To set the parameters for BIPAP:
z Touch the screen knob, which changes colour from green
to yellow = adjustment function selected.
z Turn rotary knob = adjust value displayed in screen knob.
z Press rotary knob: the screen knob changes colour from
yellow to green = setting validated and effective.
If the indicator "LED" next to a screen knob is illuminated
white, the knob setting will only be effective after the new ventilation mode has been switched on (example: »PASB« knob).
If the indicator "LED" is illuminated yellow, the relevant knob
setting is already active in the existing ventilation mode (example: »O2« knob).
The start-up values effective on switching on the ventilator are
marked on the relevant knob-scale with an arrow ( ).
(example: PASB = 0 mbar)
z Press the rotary knob: the screen key changes colour from
yellow to black = the ventilation mode is active.
For detailed instructions on setting the ventilation modes,
please refer to page 65 onwards.
014
Selecting another ventilation mode and setting its
parameters
z Touch the appropriate screen key, e. g. »BIPAP«. The key
changes colour from green to yellow, and the parameter
setting page for BIPAP is displayed.
PEEP +
10
PASB
015
Cancel selection of ventilation mode:
z Press the black screen key for the effective ventilation
mode again
or
z touch another screen key for selecting ventilation modes.
Cancel parameter setting:
z Touch screen key or screen knob again
or
z press another screen key or another screen knob.
To quit a screen page:
1 Press » « key = return to standard page
or
2 press any of the function keys next to the screen on the
right.
Evita 4
1
016
2
Instructions for Use Evita 4 / Evita 4 edition SW 4.n
25