NORTH AMERICAN DRÄGER Drager Evita XL NeoFlow User manual
Instructions for Use
Evita XL / Evita XL Neo
WARNING
For a full understanding of the
performance characteristics of this
medical device, the user should
carefully read these Instructions for
Use before use of the medical device.
Intensive Care Ventilator
Software 7.0n
Working with these Instructions for Use
The title of the main chapter in the header line
helps with orientation and navigation.
The instructions for the user combine text and
illustrations, providing a comprehensive overview
of the system. The information is presented as
sequential steps of action, allowing the user to learn
directly how to use the device.
The text provides explanations and instructs the
user step-by-step in the practical use of the
product, with short, clear instructions in easy-tofollow sequence.
1 Consecutive numbers indicate steps of action,
with the numbering restarting with “1” for each
new sequence of actions.
z Bullet points indicate individual actions or
different options for action.
– Dashes indicate the listing of data, options or
objects.
(A) Letters in parentheses refer to elements in the
relevant illustration.
The illustrations show the relationship between
the text and the device. Elements mentioned in the
text are highlighted. Unnecessary details are
omitted.
Schematic renderings of screen images guide the
user and allow to reconfirm actions performed. The
actual screen images differ in look or in
configuation.
A Letters denote elements referred to in the text.
Typografic conventions
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for
example, PEEP, Air or Apnea ventilation.
The “greater than” symbol > indicates the
navigation path in a dialog window, for example,
System Setup > Ventilation > Alarm Limits. In
this example, System Setup represents the dialog
window title, Ventilation represents a horizontal
tab and Alarm Limits a vertical tab.
These Instructions for Use apply to Evita XL and
EvitaXLNeo as well as to Evita 4 and Evita 2 dura
with the Evita XL option.
In the existing Instructions for Use, only the term
"Evita XL" is used.
2 Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Trademarks
– Evita XL
– AutoFlow
– SmartCare
are trademarks owned by Dräger.
BIPAP*)
* Trademark Used Under Licence
®
®
®
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 medical device or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Abbreviations and Symbols
Please refer to the sections "Abbreviations"
on page 27 and "Symbols" on page 32 for
explanations.
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 3
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4 Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Contents
Contents
For Your Safety and that of Your Patients . . 7
General WARNINGS and CAUTIONS . . . . . . . 10
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of Use . . . . . . . . . . . . . . . . . . . . . 16
Scope of Delivery and Available Options . . . . . 16
System Overview . . . . . . . . . . . . . . . . . . . . . . 21
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Front Connections . . . . . . . . . . . . . . . . . . . . . . 23
Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Evita XL Mobil trolley . . . . . . . . . . . . . . . . . . . . 26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Operating Concept . . . . . . . . . . . . . . . . . . . . . 35
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Buttons with a Fixed Function . . . . . . . . . . . . . 36
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Safety Information for Preparation . . . . . . . . . . 44
Safety Information for the Trolley . . . . . . . . . . . 44
Preparation of the Evita XL Mobil Trolley . . . . . 45
Preparation of the EvitaMobil Trolley . . . . . . . . 49
Positioning the Control Panel . . . . . . . . . . . . . . 51
Preparation of Evita XL for Ventilation . . . . . . . 52
Connecting Evita Remote . . . . . . . . . . . . . . . . . 62
Connecting Nurse Call . . . . . . . . . . . . . . . . . . . 63
Transportation within the hospital / Moving
Evita XL with the trolley . . . . . . . . . . . . . . . . . . 65
Starting Up . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Switching on Evita XL. . . . . . . . . . . . . . . . . . . . 68
Entering the Humidification Type . . . . . . . . . . . 69
Checking Readiness for Operation. . . . . . . . . . 70
Selecting Tube or Mask (NIV) Application
Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Selecting the Patient . . . . . . . . . . . . . . . . . . . . 79
Starting Ventilation. . . . . . . . . . . . . . . . . . . . . . 80
Setting Ventilation . . . . . . . . . . . . . . . . . . . . . . 81
ILV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
NIV – Non-Invasive Ventilation . . . . . . . . . . . . 91
Medication nebulization. . . . . . . . . . . . . . . . . . 94
Pre- and Postoxygenation for Bronchial
Suctioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . 101
Expiratory Hold . . . . . . . . . . . . . . . . . . . . . . . . 101
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Low Flow PV-Loop . . . . . . . . . . . . . . . . . . . . . 104
2 Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
O
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . 109
Mains Power Supply / DC Power Supply . . . . 111
Evita Link. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
On-Screen Alarm Messages . . . . . . . . . . . . . . 124
Displaying Alarm Information . . . . . . . . . . . . . 125
Silencing Audible Alarms. . . . . . . . . . . . . . . . . 126
Power Failure Alarm . . . . . . . . . . . . . . . . . . . . 126
Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . 127
Measured Values, Graphics, and Trends . . 129
Displaying Graphics . . . . . . . . . . . . . . . . . . . . 130
Displaying Measured Values . . . . . . . . . . . . . . 134
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Information on Sensor Calibration . . . . . . . . . . 138
Flow Sensor Calibration . . . . . . . . . . . . . . . . . 139
External Flow Compensation . . . . . . . . . . . . . 140
Neonatal Flow Sensor Calibration. . . . . . . . . . 141
2 Sensor Calibration . . . . . . . . . . . . . . . . . . . 142
O
Checking CO
2 Sensor . . . . . . . . . . . . . . . . . . . 143
Switching Monitoring Functions Off or On . . . . 151
NeoFlow Monitoring . . . . . . . . . . . . . . . . . . . . 154
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 155
Information on Configuration . . . . . . . . . . . . . . 156
System-Specific Settings. . . . . . . . . . . . . . . . . 156
Therapy-Specific Start-Up Settings . . . . . . . . . 163
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 5
Contents
Problem Solving . . . . . . . . . . . . . . . . . . . . . . .169
Alarm – Cause – Remedy . . . . . . . . . . . . . . . .170
Cleaning, Disinfection, and Sterilization . . . 189
Safety Information for Reprocessing . . . . . . . . 190
Disassembling Components and
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . 190
Reprocessing Procedure . . . . . . . . . . . . . . . . . 196
Reprocessing List for Evita XL . . . . . . . . . . . . . 198
Re-assembly of Parts . . . . . . . . . . . . . . . . . . . .200
Before Reusing on Patient . . . . . . . . . . . . . . . . 201
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Maintenance Intervals . . . . . . . . . . . . . . . . . . .204
Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Disposal of batteries. . . . . . . . . . . . . . . . . . . . . 208
Disposal of O
2 sensor . . . . . . . . . . . . . . . . . . . 208
Disposal of a neonatal flow sensor. . . . . . . . . . 208
Disposal of the medical device. . . . . . . . . . . . .208
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 209
Environmental Conditions . . . . . . . . . . . . . . . . 210
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210
APRV Airway Pressure Release Ventilation. . . 212
ATC Automatic Tube Compensation . . . . . . . . 212
2 Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . .213
O
Power Characteristics . . . . . . . . . . . . . . . . . . . 213
Display of Measured Values. . . . . . . . . . . . . . .215
Computed Value Displays . . . . . . . . . . . . . . . . 218
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Operating Data . . . . . . . . . . . . . . . . . . . . . . . . .222
Device Outputs. . . . . . . . . . . . . . . . . . . . . . . . . 226
DC Power Pack . . . . . . . . . . . . . . . . . . . . . . . .228
LUST Protocol . . . . . . . . . . . . . . . . . . . . . . . . .229
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 235
Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
Principle of Operation . . . . . . . . . . . . . . . . . . 239
Ventilation Modes. . . . . . . . . . . . . . . . . . . . . . . 240
Additional Settings . . . . . . . . . . . . . . . . . . . . . .254
Measurements . . . . . . . . . . . . . . . . . . . . . . . . . 261
Alarm – Detection/Description . . . . . . . . . . . . . 271
Screen Configurations . . . . . . . . . . . . . . . . . . . 277
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
Special ASCII Characters Used . . . . . . . . . . . .285
6
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use . . . . . . 8
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Not for use in areas of explosion hazard . . . . . 8
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Restriction of Distribution . . . . . . . . . . . . . . . . . 8
Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9
Functional Safety . . . . . . . . . . . . . . . . . . . . . . . 10
General WARNINGS and CAUTIONS . . . . . . 10
Note on EMC/ESD risk for the device
function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Sterile Accessories. . . . . . . . . . . . . . . . . . . . . . 12
Ventilation Monitoring. . . . . . . . . . . . . . . . . . . . 12
Back-up ventilation with an independent
manual ventilation device . . . . . . . . . . . . . . . . . 13
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 7
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
WARNING
Any use of the medical device requires full
understanding and strict observation of all
portions of these Instructions for Use. The
medical device is only to be used for the
purpose specified under "Intended Use"
on page 16 and in conjunction with
appropriate patient monitoring (see page 9).
Strictly observe all WARNING and CAUTION
statements throughout these Instructions for
Use and all statements on medical device
labels.
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by properly trained service
personnel.
Repair of the medical device may also only be
carried out by properly 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 medical device may
be compromised.
See chapter "Maintenance".
Accessories
WARNI NG
Only the accessories indicated on the list of
accessories 9038780 (1st edition or higher)
have been tested and approved to be used
with the medical device. Accordingly it is
strongly recommended that only these
accessories be used in conjunction with the
specific medical device. Otherwise the correct
functioning of the medical device may be
compromised.
Not for use in areas of explosion hazard
WARNI NG
This medical device 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
CAUTION
Danger to the patient
Electrical connections to equipment which is not
listed in these Instructions for Use should only be
made following consultation with the respective
manufacturers.
Restriction of Distribution
CAUTION
Device for use in health care facilities only and
exclusively by persons with specific training and
experience in its use.
8
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
For Your Safety and that of Your Patients
Networking
Device combinations approved by Dräger (see
Instructions for Use of the individual devices or
units) meet the requirements set forth by the
following standards:
– IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility; Requirements and tests
– IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
If Dräger devices or units are connected to other
Dräger devices or third-party devices and the
resulting combination is not approved by Dräger,
the correct functioning of the devices may be
compromised. The operator is responsible for
ensuring that the resulting system meets the
requirements set forth by the above standards.
Strictly follow Assembly Instructions and
Instructions for Use for each networked device.
Patient safety
The design of the medical device, the
accompanying literature, and the labeling on the
medical device take into consideration that the
purchase and use of the medical device are
restricted to trained professionals, and that certain
inherent characteristics of the medical device 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 medical device, to
the consequences of medical device misuse, and
to potentially adverse effects in patients with
abnormal conditions. Medical device modification
or misuse can be dangerous.
CAUTION
Danger to the patient.
Individual measured values and monitoring
parameters should not be used as the sole basis
for therapeutic decisions.
Patient monitoring
The operators of the medical device are
responsible for choosing appropriate safety
monitoring that supplies adequate information on
medical device performance and patient condition.
Patient safety may be achieved through a wide
variety of means ranging from electronic
surveillance of medical device 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 medical
device operator.
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 9
For Your Safety and that of Your Patients
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 O
breathing gas,
or, if a set limit is exceeded, by an appropriate
alarm. The medical device is equipped with basic
safety features to reduce the possibility of patient
injury while the cause of an alarm is remedied.
2 concentration in the
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to
general operation of the medical device.
WARNINGS and CAUTIONS specific to
subsystems or particular features appear with
those topics in later sections of these Instructions
for Use or in the Instructions for Use of any product
being used with this device.
WARNING
Evita XL must only be used under the
supervision of qualified medical personnel in
order to provide immediate corrective action
in the case of a malfunction.
WARNING
Always use a ventilator that has been cleaned
and disinfected and has been successfully
tested to be ready for operation.
WARNI NG
This device is to be used only in rooms with
line power installations complying with
national and international safety standards for
hospital patient rooms (e.g., according to
international standard IEC 60364-7-710
"Electrical installations of buildings - Part 7710: Requirements for special installations or
locations - Medical locations").
To maintain grounding integrity, connect only
to a "hospital grade" receptacle. Always
disconnect supply before servicing.
WARNI NG
Do not use the device in conjunction with
flammable gases or anesthetics - fire hazard!
WARNI NG
Do not use Evita XL in hyperbaric chambers.
Device malfunction may result, with the risk of
patient injury.
WARNI NG
Do not use in conjunction with magnetic
resonance imaging (MRI)! Device malfunction
may result, with the risk of patient injury.
10
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
For Your Safety and that of Your Patients
WARNING
Using high frequency electrosurgery
equipment, defibrillators, or short-wave
treatment equipment in the vicinity of the
device may interfere with its operation and
pose a risk of patient injury.
WARNING
Never use flammable medications (e.g. on the
basis of isopropyl alcohol) or other
substances based on flammable solvents in
the breathing system. Always provide
adequate ventilation when using flammable
substances for disinfection. Flammable
vapors may otherwise ignite when calibrating
the flow sensor and destroy the flow sensor in
the process. Fire hazard!
WARNING
Always use extreme caution when using
oxygen!
Oxygen intensely supports any burning! No
smoking, no open fire in areas where oxygen
is in use!
Always provide adequate ventilation in order
to maintain ambient O
2 concentrations of
21 %.
Always secure O
2 cylinders against tipping
over, do not expose to extreme heat.
Do not use oil or grease on O
2 equipment such
as tank valves or pressure regulators. Do not
touch with oily hands. Risk of fire!
Open and close valves slowly, with smooth
turns. Do not use any tools.
WARNING
Do not block air intake. Ventilator malfunction
will result.
WARNING
Do not place any container with liquids
(e.g., infusion bottle) above or on top of
Evita XL. Any liquid getting into the device
could prevent Evita XL from working properly
or damage it and endanger the patient.
WARNING
When using Evita XL in combination with
other products and when using Evita XL
during transportation within the hospital the
person responsible for operating the device
must ensure that all equipment is adequately
secured in accordance with applicable safety
standards.
CAUTION
The touch active area of the screen has a
sensitive surface. Damage to the surface will lead
to malfunctions when using the touch active
operating elements. Do not operate the touch
active area of the screen with sharp objects. Do
not damage the screen surface of Evita XL when
cleaning or during transportation within the
hospital.
NOTE
The risk of endangering the patient by software
errors is minimized as follows:
A software development process is applied that
conforms with the state-of-the-art technology and
international standards for medical devices.
WARNING
Always heed all precautions and follow all
hospital protocols with respect to the
administration of oxygen. Make adjustments
to the FiO
2 according to the blood gas values
measured.
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 11
For Your Safety and that of Your Patients
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 provided on page 235.
Portable and mobile RF communications
equipment can affect medical electrical equipment.
WARNING
Connector pins with an electrostatic
discharge (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.
Sterile Accessories
CAUTION
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged or there
are other signs of non-sterility. Disposable articles
may not be reprocessed and resterilized.
Ventilation Monitoring
The monitoring integrated in Evita XL monitors the
following parameters:
– Airway pressure, P
– Expiratory minute volume, MV
– Inspiratory tidal volume, V
– Inspiratory O2 concentration, FiO2
– Inspiratory breathing gas temperature, T
– End-expiratory CO
– Apnea time, TApnea
– Respiratory rate, fspn
Changes in these parameters may be caused by:
– acute changes in the patient’s condition
– incorrect settings and user error
– device fault conditions
– failure of power and gas supplies
WARNI NG
In case of malfunction of any of the built-in
monitoring, a substitute must be provided in
order to maintain an adequate level of
monitoring. The operator of the ventilator
system must still assume full responsibility
for proper ventilation and patient safety in all
situations.
During O
2 Therapy, the monitoring functions of
Evita XL are restricted.
AW
Ti
2 concentration, etCO2
Reuse, processing or sterilization can lead to a
failure of the medical devices and cause injuries to
patient.
12
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Back-up ventilation with an independent
manual ventilation device
WARNING
The user should ensure that back-up
ventilation with an independent manual
ventilation device is always available.
If a fault is detected in Evita XL, so that its lifesupport functions are no longer assured: start
ventilation using an independent ventilation
device without delay – if necessary with PEEP
and/or an increased inspiratory O
concentration (e.g., with manual breathing
bag MR 100).
2
For Your Safety and that of Your Patients
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 13
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14 Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Application
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of Use . . . . . . . . . . . . . . . . . . . . 16
Scope of Delivery and Available Options. . . 16
Evita XL without options . . . . . . . . . . . . . . . . . . 16
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Monitoring in accordance with the options
used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Application
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 15
Application
Intended Use
Evita XL – Long-term ventilator for intensive care.
For adults, children, and neonates with a minimum
body weight of 3 kg (6.6 lbs).
For premature infants with a minimum body weight
of 0.5 kg (1.1 lbs) only with the NeoFlow option.
EvitaXLNeo* – Long-term ventilator for intensive
care.
For children, neonates, and premature infants with
a minimum body weight of 0.5 kg (1.1 lbs).
For adults only with the Adult option.
* In some countries only available under the name
Environment of Use
In the intensive care ward or in the recovery room.
During transportation of ventilated patients within
the hospital.
Scope of Delivery and Available Options
Evita XL without options
Evita XL for the Adult and Pediatric patient
categories
EvitaXLNeo for the Neonatal and Pediatric patient
categories
Evita XL and EvitaXLNeo can be supplemented
with options, see page 18.
– PLV (Pressure Limited Ventilation)
– AutoFlow
– IRV (Inversed Ratio Ventilation)
Evita XL.
Pressure limited constant-volume ventilation
®
for automatic setting of inspiratory flow and
insp
P
Ventilation with inversed inspiration/expiration
ratio
CMV ventilation mode
Continuous Mandatory Ventilation
Volume-controlled ventilation with fixed mandatory
minute volume.
With the functions:
– CPPV (Continuous Positive Pressure
Ventilation) Controlled ventilation with
continuous positive airway pressure
16
SIMV ventilation mode
Synchronized Intermittent Mandatory Ventilation
Combines mechanical (volume-controlled)
ventilation with spontaneous breathing.
With the functions:
– PLV (Pressure Limited Ventilation)
Pressure limited constant-volume ventilation
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Application
– AutoFlow
®
for automatic setting of inspiratory flow and
insp
P
SB (Spontaneous Breathing)
Spontaneous breathing at ambient pressure
PCV+ ventilation mode
Pressure Controlled Ventilation plus
(BIPAP* (Biphasic Positive Airway Pressure))
Pressure-controlled ventilation combined with free
spontaneous breathing during the complete
breathing cycle and adjustable pressure support on
CPAP level.
CPAP ventilation mode
Continuous Positive Airway Pressure
Spontaneous breathing with positive airway
pressure.
PSupp. ventilation mode
Pressure-supported spontaneous breathing.
ILV ventilation mode
Independent Lung Ventilation
Differential, synchronized ventilation with two Evita
devices, independently ventilating each lung.
If apnea occurs, Evita XL sounds an alarm after the
preset alarm period (T
Apnea ) and starts apnea
ventilation.
O2 Therapy
Continuous flow application with adjustable O
2
concentration and flow for the O2 Therapy function
for patients with independent breathing and using
oxygen masks.
DC power pack**
Integrated DC power pack supplying Evita XL with
power from two internal 12 V lead-acid gel batteries
for a maximum of 10 minutes.
For uninterrupted operation in case of mains power
failure, Evita XL automatically switches over to the
internal batteries.
MEDIBUS
Software protocol for the transfer of data between
Evita XL and an external medical or non-medical
device (e.g., patient monitors or computers for data
management systems) via an RS 232 interface,
see "MEDIBUS for Dräger Intensive Care Devices"
(9028329).
Automatic gas switch-over
In the event of a gas failure, Evita XL automatically
switches over to the other gas supply available.
Apnea ventilation additional setting
If apnea occurs while Apnea Ventilation is
activated, the system automatically switches over
to mandatory ventilation.
In the Adult and Pediatric patient categories, the
device switches over to volume-controlled
ventilation.
In the Neonatal patient category, the device
Other features
– Standard display of waveforms, measured
values, and PV-Loop
– Three waveforms can be displayed on-screen
at the same time
– PV-Loop
Evita XL offers limited configurability.
switches over to pressure-controlled ventilation.
** Optional on Evita 4 and Evita 2 dura with the Evita XL
* Trademark Used Under Licence
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 17
option
Application
Options
Evita XL displays the options available in the
device, see "Displaying available options"
on page 162.
NIV – Non-Invasive Ventilation
Patients with spontaneous breathing are supported
with non-invasive ventilation therapies using a
nasal or face mask.
Choice between mask ventilation and ventilation of
intubated patients.
LPP* (Lung Protection Package)
– Recruitment Trends
– Low Flow PV-Loop
Adult
Standard on Evita XL
Addition of Adult patient category to Evita XL Neo
ATC (Automatic Tube Compensation)
Compensation of tube resistance
Can be used with all ventilation modes.
XL Ventilation Plus
Additional ventilation modes:
– APRV (Airway Pressure Release Ventilation)
Spontaneous breathing on two independentlyadjustable pressure levels with long time
ranges.
– MMV (Mandatory Minute (Volume) Ventilation)
Spontaneous breathing with automatic
adjustment of mandatory ventilation to the
patient's minute volume requirement.
With the functions:
– PLV (Pressure Limited Ventilation)
Pressure limited constant-volume
ventilation.
–AutoFlow
®
for automatic setting of inspiratory flow and
insp
P
– PCV+ Assist (Pressure Controlled Ventilation
plus, Assisted (BIPAP Assist))
Pressure-controlled, assisted ventilation
XL Monitoring Plus
Additional loops, trends, and diagnostic functions
– Intrinsic PEEP measurement
Determination of Intrinsic PEEP and measuring
trapped volume (air trapping)
– Occlusion pressure measurement
Evaluation of patient’s breathing drive during
spontaneous breathing
– Negative Inspiratory Force NIF
Measurement of the patient's maximum
inspiratory effort following expiration
–RSB
Rapid Shallow Breathing
XL Configuration Plus
Additional configuration possibilities for:
– Measured values
– Buttons in the main menu bar
– Screen configurations
– Customized values and settings
SmartCare / PS**
Knowledge-based system for clinical guidelines.
For the use of SmartCare / PS the following options
are additionally required:
– CapnoPlus
–ATC
– XL Monitoring Plus
– XL Configuration Plus
* Not available on Evita XL Neo ** Not available on EvitaXLNeo
18
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Application
NeoFlow
Standard on EvitaXLNeo
Neonatal mode with basic flow
Extends the range of uses of Evita XL to include
long-term ventilation of premature infants through
addition of the Neo. patient category.
In the Ped. and Neo. patient categories, a
proximal neonatal flow sensor is used for flow
monitoring.
NurseCall
– Nurse call for connection to central hospital
alarm system
– Connection option for Remote Pad
CapnoPlus
Proximal CO
2 measurement
Evita Link
Interface card
Output of measured values, status messages and
alarm messages to connected equipment for
monitoring, documentation, or further processing.
External battery for DC power pack
Extension of integrated DC power pack with
external 12 V or 24 V lead-acid gel batteries.
For uninterrupted operation for max. 2 hours in
case of mains supply failure
For supplying power during transportation within
the hospital
Remote Pad
Remote control of routine functions
Monitoring in accordance with the
options used
– Airway pressure, PAW
– Expiratory minute volume, MV
– Inspiratory tidal volume, V
– Inspiratory O2 concentration, FiO2
– Inspiratory breathing gas temperature, T
– Apnea time, T
Apnea
– Respiratory rate, fspn
– End-expiratory CO2 concentration, etCO2
Ti
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 19
This page has intentionally been left blank.
20 Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
System Overview
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . 22
Front Connections . . . . . . . . . . . . . . . . . . . . . 23
Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Evita XL Mobil trolley . . . . . . . . . . . . . . . . . . . 26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 27
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
System Overview
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 21
System Overview
Control Panel
I
A
B
C
D
E
F
G
H
A Audio paused 2 min. or Alarm Silence
key for suppressing the alarm tone for two
minutes
B Alarm Limits key for setting alarm limits
C Ventilator Settings key for setting
ventilation mode and ventilation parameters
D Unassigned key for future functions
E Sensor Parameter key for calibrating
sensors and for switching monitoring on or off
1
2
3
F System Setup key for configuring device
functions
G Start/Standby key for switching between
operation and standby mode
H Rotary knob for selecting and confirming
settings
22
MT-0071-2008
I Touch-sensitive screen
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Front Connections
System Overview
B
A
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)
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 23
C
D
E
FH
G
H Locking screw for protective cover
(behind it: O
2 sensor and ambient air filter)
MT-0072-2008
System Overview
Back Panel
ABC
Q
P
O
N
M
A Power switch with protective flap
B COM 2, COM 3 ports for RS 232, 2 CAN
interfaces and analog interface (optional)
C Connection for Remote Pad (optional)
D Connection for nurse call (optional)
E Cooling-air filter
F Connection for neonatal flow sensor (optional)
G ILV socket for the connecting cable for
independent lung ventilation with two
ventilators
H Connection for O
I Connection for medical air (Air)
2
D
E
F
G
J
J Temp socket for temperature sensor
K CO
2 socket for CO2 sensor (optional)
L COM 1 RS 232C port for RS 232 interface,
e.g., for printer
M Rating plate (not visible) on the left-hand side
panel
N AC fuses
O Connector for power cable
P DC socket
Q Fan
IHKL
EvitaXL_back_panel
24
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
Labels
Main WARNING/CAUTION label
DANGER !
RISK OF EXPLOSION IF USED IN THE
PRESENCE OF FLAMMABLE ANESTHETICS
WARNING !
DISCONNECT SUPPLY BEFORE SERVICING
REPAIRS ON THIS EQUIPMENT TO BE
PERFORMED ONLY BY DrägerService OR ITS
AUTHORIZED SERVICE CENTERS
CAUTION !
TO MAINTAIN GROUNDING INTEGRITY,
CONNECT ONLY TO A "HOSPITAL GRADE"
RECEPTACLE
TO REDUCE RISK OF ELECTRIC SHOCK, DO
NOT REMOVE COVER
USE ONLY DRY AND CLEAN COMPRESSED
AIR AND OXYGEN. WATER IN GAS SUPPLY
CAN CAUSE EQUIPMENT MALFUNCTION
FEDERAL (USA) LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN
System Overview
No pushing
Air intake CAUTION label
CAUTION !
DO NOT BLOCK
AIR INTAKE
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 25
System Overview
Evita XL Mobil trolley
B
A
C
D
E
F
G
H
A Evita XL
B Handle
C Trolley column
D Hose hook
E Humidifier holder (optional)
F Alignment aid
G Universal bracket with standard rail (optional)
H Dual castors with locking brakes, 4 x
123
26
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
System Overview
Abbreviations
Abbreviation Description
Adult Option for EvitaXLNeo so that the device can be used for adults
Alarm Info Display alarm causes and remedies
Alarm Reset Acknowledge alarm message
APRV Airway Pressure Release Ventilation. Spontaneous breathing at continuous positive
airway pressure with short-term pressure release
ATC Automatic Tube Compensation
AutoFlow Special function for automatic regulation of the inspiratory flow during volume-controlled
ventilation, enables free deep breathing
BIPAP Assist
(PCV+ Assist)
BIPAP
(PCV+)
bpm Breaths per minute
BTPS Body Temperature, Pressure, Saturated
C Compliance
CAN Controller Area Network
CCP Critical Closing Pressure
CMV Continuous Mandatory Ventilation
CMV
Assist Trigger-assisted Continuous Mandatory Ventilation
CO
2 CO2 production [L/min]
Comp. Degree of tube compensation (set value)
COPD Chronic Obstructive Pulmonary Disease
CPAP Continuous Positive Airway Pressure. Spontaneous breathing with positive airway
CPAP/ PSupp Spontaneous breathing with positive airway pressure and pressure support
CPPV Continuous Positive Pressure Ventilation
C
stat Static compliance
Δint.PEEP Intermittent Positive End-Expiratory Pressure (expiratory sigh)
ΔP
Apnea Set value for PApnea relative to PEEP
ΔP
AW Pressure support on the tube
ΔPSupp Set value for P
EIP End-inspiratory pressure
Biphasic Positive Airway Pressure Assisted. Ventilation mode for assisted ventilation
with continuous positive airway pressure with two different pressure levels
Biphasic Positive Airway Pressure. Ventilation mode for spontaneous breathing at
continuous positive airway pressure with two different pressure levels
Measured values based on the conditions of the patient lungs: body temperature 37 °C
(98.6 °F), water-vapor saturated gas, ambient pressure
Intermittent ventilation with positive pressure
pressure
Controlled ventilation with continuous positive airway pressure
Supp. relative to PEEP
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 27
System Overview
Abbreviation Description
EMC Electromagnetic compatibility
etCO
2 End-expiratory CO2 concentration
Ext. Flow External Flow
f Respiratory rate in bpm
Fail to cycle Breathing cycle failure. Ventilator detects no inspiration
f
Apnea Respiratory rate setting for apnea ventilation
FeCO
2 Expiratory CO2 concentration
FiO
2 Inspiratory O2 concentration
Flow Set value of the maximum inspiratory flow
In the Neonatal patient category:
Displayed real-time waveform, patient flow, with leakage correction (measured value)
FlowAssist Adjustable pressure assistance in proportion to patient flow
Flow
bf Basic flow (system setting), see "Power Characteristics" on page 213
Flow
exp Expiratory flow, without leakage correction
Flowinsp Inspiratory flow, without leakage correction
Flow
leak Current leakage flow
Flow
out Flow through the expiratory valve during inspiration
Flowpatient Inspiratory/expiratory flow, with leakage correction (measured value)
f
mand Mandatory mechanical portion of overall respiratory rate
f
spn Spontaneous breathing portion of overall respiratory rate
ftotal Total respiratory rate (fmand + fspn)
f
trig. Triggered portion of overall respiratory rate
I : E Ratio of inspiratory : expiratory time
IBW Ideal Body Weight
ID ∅ Internal tube diameter (set value)
ILV Independent Lung Ventilation
Ventilation with two ventilators, one for each lung
insp. flow Inspiratory Flow
IPPV Intermittent Positive Pressure Ventilation
Intermittent ventilation with positive pressure
IPPV
Assist Trigger-assisted Intermittent Positive Pressure Ventilation
IRV Inversed Ratio Ventilation. Ventilation with inversed ratio of inspiration/expiration
KG Body weight [kg]
K
Tube Tube coefficient
LIP Lower Inflection Point
LUST List-controlled universal interface driver program
MEDIBUS Dräger communication protocol for medical devices
28
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
System Overview
Abbreviation Description
MMV Mandatory Minute (Volume) Ventilation
MV Minute volume, without leakage correction (measured value)
MVleak Leakage minute volume – mean leakage flow, averaged over inspiration and expiration
(measured value)
MV
Patient Expiratory measured minute volume, with leakage correction
MVspn Spontaneously breathed minute volume
NeoFlow Option for Evita XL so that the device can be used for neonates
NIF Negative Inspiratory Force. Maximum inspiratory effort
NIV Non-Invasive Ventilation, mask ventilation
NTC Negative Temperature Coefficient
NTPD Normal Temperature, Pressure, Dry
O
2 Set value for inspiratory O2 concentration [Vol.%]
O
2↑ suction Oxygenation program active
P0.1 100 ms occlusion pressure
P
Apnea Set value for inspiratory pressure with apnea ventilation
P
AW Airway pressure at the Y-piece (measured value)
PCV+ Assist
(BIPAP Assist)
PCV+
(BIPAP)
Ventilation mode for assisted ventilation with continuous positive airway pressure with
two different pressure levels
Ventilation mode for spontaneous breathing at continuous positive airway pressure with
two different pressure levels
PEEP Positive End-Expiratory Pressure
PEEP
i Intrinsic PEEP
P
exp Airway pressure in the expiratory breathing hose
high Set value of the upper pressure level in APRV
P
P
insp Set value of the upper pressure level in PCV+
Pleth Plethysmogram
P
limit Set value of maximum applied airway pressure during measuring maneuver Low Flow
PV-Loop
P
low Set value for the lower pressure level in APRV
PLV Pressure Limited Ventilation
P
max Maximum airway pressure
PMC Point of Maximum Curvature
P
mean Mean airway pressure at the Y-piece (measured value)
P
min Minimum airway pressure
Ppeak Peak pressure
P
plat End-inspiratory airway pressure
PS Pressure Support
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n 29
System Overview
Abbreviation Description
Pstart Initial airway pressure during measuring maneuver Low Flow PV-Loop
PSupp. Pressure-supported spontaneous breathing
P
Supp. Set value for PSupp. pressure support
PSV Pressure-supported spontaneous breathing
P
Trach Pressure in the trachea
QRS Intraventricular excitation propagation in the ECG
RResistance
RecrTrend Recruitment Trend. Breath-based trend
R
exp Flow resistance of the expiratory breathing hose
R
insp Flow resistance of the inspiratory breathing hose
RSBi Rapid Shallow Breathing. Quotient of spontaneous breathing rate and tidal volume
SB Spontaneous Breathing. Spontaneous breath at ambient pressure
SIMV Synchronized Intermittent Mandatory Ventilation
Slope Pressure rise time for PSupp.
SpO
2 Functional oxygen saturation
T Inspiratory breathing gas temperature
T
Apnea Apnea alarm delay time
Ta ue Respiratory time constant, expiratory:
– with activated leakage compensation = leakage-compensated tidal volume /
leakage-compensated maximum expiratory flow
– with deactivated leakage compensation = expiratory tidal volume / maximum
expiratory flow
Tdeconnect Delay time for alarm limit PAW (airway pressure low) in Mask (NIV) application mode
e Expiratory time
T
TGI Tracheal Gas Insufflation
T
high Time for the upper pressure level in APRV
Ti Inspiratory time
T
i max Set value of the inspiratory time with non-invasive ventilation in CPAP/ PSupp
ventilation mode
insp Set value of the inspiratory time
T
T
low Time for the lower pressure level in APRV
Tmax [sec] Maximum period of measuring maneuver Low Flow PV-Loop
Trigg. [L/min] Set value for the flow trigger threshold
UIP Upper Inflection Point
UMDNS Universal Medical Device Nomenclature System
V
ds Serial dead space
V
limit Set value of maximum applied volume during measuring maneuver Low Flow PV-Loop
Vol .Assist Adjustable pressure support in proportion to tidal volume
30
Instructions for Use Evita XL / EvitaXLNeo SW 7.0n
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