evita_xl_and_evita_xl_neo_instructions_for_use_sw_7.pdf
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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
Page 2
Working with these Instructions for Use
The title of the main chapter in the header line
helps with orientation and navigation.
Typografic conventions
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.
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for
example, PEEP, Air or Apnoea ventilation.
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.
–
The “greater than” symbol > indicates the
navigation path in a dialog window, for example,
System Setup > Therapy > Alarm Limits. In this
example, System Setup represents the dialog
window title, Therapy represents a horizontal tab
and Alarm Limits a vertical tab.
These Instructions for Use apply to Evita XL and
Evita XL Neo 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.
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.
2
Instructions for Use Evita XL SW 7.0n
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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 24 and "Symbols" on page 28 for
explanations.
Instructions for Use Evita XL SW 7.0n
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This page has intentionally been left blank.
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Instructions for Use Evita XL SW 7.0n
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Contents
Contents
7
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
73
General WARNINGS and CAUTIONS . . . . . . . 10
For Your Safety and that of Your Patients . .
Selecting the Patient . . . . . . . . . . . . . . . . . . . .
Starting Ventilation. . . . . . . . . . . . . . . . . . . . . .
Setting Ventilation . . . . . . . . . . . . . . . . . . . . . .
ILV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NIV – Non-Invasive Ventilation . . . . . . . . . . . .
Medication nebulization. . . . . . . . . . . . . . . . . .
Pre- and Postoxygenation for Bronchial
Suctioning . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manual Inspiration . . . . . . . . . . . . . . . . . . . . . .
Expiratory Hold . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low Flow PV-Loop . . . . . . . . . . . . . . . . . . . . .
O2 Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . .
Mains Power Supply / DC Power Supply . . . .
Evita Link. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
75
76
77
84
87
91
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environment of Use . . . . . . . . . . . . . . . . . . . . . 14
Scope of Delivery and Available Options . . . . . 14
System Overview . . . . . . . . . . . . . . . . . . . . . . 19
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . .
Front Connections . . . . . . . . . . . . . . . . . . . . . .
Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Evita XL Mobil trolley . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
21
22
23
24
28
Operating Concept . . . . . . . . . . . . . . . . . . . . . 31
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Buttons with a Fixed Function . . . . . . . . . . . . . 32
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Safety Information for Preparation . . . . . . . . . .
Safety Information for the Trolley . . . . . . . . . . .
Preparation of the Evita XL Mobil Trolley . . . . .
Preparation of the EvitaMobil Trolley . . . . . . . .
Positioning the Control Panel . . . . . . . . . . . . . .
Preparation of Evita XL for Ventilation . . . . . . .
Connecting Evita Remote. . . . . . . . . . . . . . . . .
Connecting Nurse Call . . . . . . . . . . . . . . . . . . .
Transportation within the hospital / Moving
Evita XL with the trolley . . . . . . . . . . . . . . . . . .
40
40
41
45
47
48
58
60
62
Starting Up . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Switching on Evita XL. . . . . . . . . . . . . . . . . . . .
Entering the Humidification Type . . . . . . . . . . .
Checking Readiness for Operation. . . . . . . . . .
Selecting Tube or Mask (NIV) Application
Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
64
65
66
71
96
98
98
99
101
104
106
108
115
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
On-Screen Alarm Messages . . . . . . . . . . . . . .
Displaying Alarm Information . . . . . . . . . . . . .
Silencing Audible Alarms. . . . . . . . . . . . . . . . .
Power Failure Alarm . . . . . . . . . . . . . . . . . . . .
Setting Alarm Limits . . . . . . . . . . . . . . . . . . . .
120
121
122
122
123
Measured Values, Graphics, and Trends . . 125
Displaying Graphics . . . . . . . . . . . . . . . . . . . . 126
Displaying Measured Values . . . . . . . . . . . . . . 130
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Information on Sensor Calibration. . . . . . . . . .
Flow Sensor Calibration . . . . . . . . . . . . . . . . .
External Flow Compensation . . . . . . . . . . . . .
Neonatal Flow Sensor Calibration . . . . . . . . . .
O2 Sensor Calibration . . . . . . . . . . . . . . . . . . .
Checking CO2 Sensor . . . . . . . . . . . . . . . . . . .
Switching Monitoring Functions Off or On . . . .
NeoFlow Monitoring . . . . . . . . . . . . . . . . . . . .
134
135
136
137
138
139
147
150
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 151
Information on Configuration . . . . . . . . . . . . . . 152
System-Specific Settings. . . . . . . . . . . . . . . . . 152
Therapy-Specific Start-Up Settings . . . . . . . . . 159
Instructions for Use Evita XL SW 7.0n
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Page 6
Contents
Problem Solving . . . . . . . . . . . . . . . . . . . . . . . 165
Alarm – Cause – Remedy . . . . . . . . . . . . . . . . 166
Cleaning, Disinfection, and Sterilization . . . 183
Safety Information for Reprocessing . . . . . . . . 184
Disassembling Components and
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Reprocessing Procedure . . . . . . . . . . . . . . . . . 190
Reprocessing List for Evita XL . . . . . . . . . . . . . 192
Re-assembly of Parts . . . . . . . . . . . . . . . . . . . . 194
Before Reusing on Patient . . . . . . . . . . . . . . . . 195
References . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Special ASCII Characters Used . . . . . . . . . . . 284
Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Maintenance Intervals . . . . . . . . . . . . . . . . . . . 198
Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Safety Information . . . . . . . . . . . . . . . . . . . . . . 202
Disposal of batteries. . . . . . . . . . . . . . . . . . . . . 202
Disposal of O2 sensor . . . . . . . . . . . . . . . . . . . 202
Disposal of a neonatal flow sensor. . . . . . . . . . 202
Disposal of the medical device. . . . . . . . . . . . . 203
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 205
Environmental Conditions . . . . . . . . . . . . . . . . 206
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
APRV Airway Pressure Release Ventilation. . . 208
ATC Automatic Tube Compensation . . . . . . . . 208
PPS Proportional Pressure Support. . . . . . . . . 209
O2 Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Power Characteristics . . . . . . . . . . . . . . . . . . . 210
Display of Measured Values . . . . . . . . . . . . . . . 212
Computed Value Displays . . . . . . . . . . . . . . . . 216
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Operating Data . . . . . . . . . . . . . . . . . . . . . . . . . 219
Device Outputs . . . . . . . . . . . . . . . . . . . . . . . . . 223
DC Power Pack . . . . . . . . . . . . . . . . . . . . . . . . 225
LUST Protocol . . . . . . . . . . . . . . . . . . . . . . . . . 226
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 232
Principle of Operation . . . . . . . . . . . . . . . . . . 237
Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . 238
Additional Settings . . . . . . . . . . . . . . . . . . . . . . 253
Measurements . . . . . . . . . . . . . . . . . . . . . . . . . 260
Alarm – Detection/Description . . . . . . . . . . . . . 270
Screen Configurations . . . . . . . . . . . . . . . . . . . 276
6
Instructions for Use Evita XL SW 7.0n
Page 7
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
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sterile Accessories . . . . . . . . . . . . . . . . . . . . . .
Ventilation Monitoring . . . . . . . . . . . . . . . . . . . .
Back-up ventilation with an independent
manual ventilation device . . . . . . . . . . . . . . . . .
Instructions for Use Evita XL SW 7.0n
11
11
12
12
7
Page 8
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 14 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.
Accessories
WARNING
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
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".
8
WARNING
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.
Instructions for Use Evita XL SW 7.0n
Page 9
For Your Safety and that of Your Patients
Networking
Patient safety
Device combinations approved by Dräger (see
Instructions for Use of the individual devices or
units) meet the requirements set forth by the
following standards:
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.
–
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.
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 SW 7.0n
9
Page 10
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 O2 concentration in the
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.
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
Do not use the device in conjunction with
flammable gases or anesthetics - fire hazard!
WARNING
Do not use Evita XL in hyperbaric chambers.
Device malfunction may result, with the risk of
patient injury.
10
WARNING
Do not use in conjunction with magnetic
resonance imaging (MRI)! Device malfunction
may result, with the risk of patient injury.
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!
Instructions for Use Evita XL SW 7.0n
Page 11
For Your Safety and that of Your Patients
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 the relevant basic
requirements of Directive 93/42/EEC.
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.
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 232.
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.
Reuse, processing or sterilization can lead to a
failure of the medical devices and cause injuries to
patient.
Instructions for Use Evita XL SW 7.0n
11
Page 12
For Your Safety and that of Your Patients
Ventilation Monitoring
The monitoring integrated in Evita XL monitors the
following parameters:
–
Airway pressure, PAW
–
Expiratory minute volume, MV
–
Inspiratory tidal volume, VTi
–
Inspiratory O2 concentration, FiO2
–
Inspiratory breathing gas temperature, T
–
End-expiratory CO2 concentration, etCO2
–
Apnea time, TApnoea
–
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
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.
During O2 Therapy, the monitoring functions of
Evita XL are restricted.
Back-up ventilation with an independent
manual ventilation device
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 O2 concentration (e.g., with
manual breathing bag MR 100).
12
Instructions for Use Evita XL SW 7.0n
Page 13
Application
Application
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environment of Use . . . . . . . . . . . . . . . . . . . . 14
Scope of Delivery and Available Options. . . 14
Evita XL without options . . . . . . . . . . . . . . . . . . 14
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Monitoring in accordance with the options
used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Instructions for Use Evita XL SW 7.0n
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Page 14
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) with the NeoFlow option.
Evita XL Neo* – 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 with the Adult option.
*
In some countries only available under the name
Evita XL.
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
–
PLV (Pressure Limited Ventilation)
Pressure limited constant-volume ventilation
Evita XL for the Adult and Pediatric patient
categories
–
AutoFlow®
for automatic setting of inspiratory flow and
Pinsp
–
IRV (Inversed Ratio Ventilation)
Ventilation with inversed inspiration/expiration
ratio
Evita XL Neo for the Neonatal and Pediatric patient
categories
Evita XL and Evita XL Neo can be supplemented
with options, see page 16.
IPPV ventilation mode
SIMV ventilation mode
Intermittent Positive Pressure Ventilation
Synchronized Intermittent Mandatory Ventilation
Volume-controlled ventilation with fixed mandatory
minute volume.
Combines mechanical (volume-controlled)
ventilation with spontaneous breathing.
With the functions:
With the functions:
–
–
14
CPPV (Continuous Positive Pressure
Ventilation) Controlled ventilation with
continuous positive airway pressure
PLV (Pressure Limited Ventilation)
Pressure limited constant-volume ventilation
Instructions for Use Evita XL SW 7.0n
Page 15
Application
–
AutoFlow®
for automatic setting of inspiratory flow and
Pinsp
If apnea occurs, Evita XL sounds an alarm after the
preset alarm period (TApnoea
) and starts apnea
ventilation.
SB (Spontaneous Breathing)
O2 Therapy
Spontaneous breathing at ambient pressure
Continuous flow application with adjustable O2
concentration and flow for the O2 Therapy function
for patients with independent breathing and using
oxygen masks.
BIPAP* ventilation mode
Biphasic Positive Airway Pressure
Pressure-controlled ventilation combined with free
spontaneous breathing during the complete
breathing cycle and adjustable pressure support on
CPAP level.
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.
Continuous Positive Airway Pressure
For uninterrupted operation in case of mains power
failure, Evita XL automatically switches over to the
internal batteries.
Spontaneous breathing with positive airway
pressure.
MEDIBUS
CPAP ventilation mode
ASB ventilation mode
Assisted Spontaneous Breathing
Pressure-supported spontaneous breathing.
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).
ILV ventilation mode
Independent Lung Ventilation
Differential, synchronized ventilation with two Evita
devices, independently ventilating each lung.
Apnoea 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.
Automatic gas switch-over
In the event of a gas failure, Evita XL automatically
switches over to the other gas supply available.
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.
In the Neonatal patient category, the device
switches over to pressure-controlled ventilation.
**
*
Trademark Used Under Licence
Instructions for Use Evita XL SW 7.0n
Optional on Evita 4 and Evita 2 dura with the Evita XL
option
15
Page 16
Application
Options
Evita XL displays the options available in the
device, see "Displaying available options"
on page 158.
PPS* (Proportional Pressure Support)
Differential proportional support of spontaneous
breathing in cases of pathological compliance
and/or resistance.
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
Pinsp
–
BIPAP Assist (Biphasic Positive Airway
Pressure Assisted)
Pressure-controlled, assisted ventilation
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.
NIV Plus
In addition to NIV:
– Evita XL detects the patient’s inspiration and
switches automatically from Standby Plus
mode to non-invasive ventilation
– When the mask is removed, patient flow is
reduced until the mask is put back on
– Extended leakage compensation
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
LPP** (Lung Protection Package)
–
–
Recruitment Trends
Low Flow PV-Loop
Adult
Standard on Evita XL
Addition of Adult patient category to Evita XL Neo
XL Configuration Plus
ATC (Automatic Tube Compensation)
Compensation of tube resistance
Can be used with all ventilation modes.
*
**
16
Not available for the US market
Not available on Evita XL Neo
Additional configuration possibilities for:
– Measured values
– Buttons in the main menu bar
– Screen configurations
– Customized values and settings
Instructions for Use Evita XL SW 7.0n
Page 17
Application
SmartCare / PS*
External battery for DC power pack
Knowledge-based system for clinical guidelines.
Extension of integrated DC power pack with
external 12 V or 24 V lead-acid gel batteries.
For the use of SmartCare / PS the following options
are additionally required:
– CapnoPlus
– ATC
– XL Monitoring Plus
– XL Configuration Plus
NeoFlow
Standard on Evita XL Neo
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 Paed. and Neo. patient categories, a
proximal neonatal flow sensor is used for flow
monitoring.
For uninterrupted operation for max. 2 hours in
case of mains supply failure
For supplying power during transportation within
the hospital
Quiet Power Failure Alarm**
Evita XL can be equipped with a quiet version of the
power failure alarm for use in particularly quiet
clinical environments.
Quiet loudspeaker
Evita XL can be equipped with a quiet version of the
alarm enunciator for use in particularly quiet clinical
environments.
Remote Pad
NurseCall
–
–
Nurse call for connection to central hospital
alarm system
Connection option for Remote Pad
CapnoPlus
Remote control of routine functions
Insp. term. PIF
Adjustable criterion for the termination of
ASB breaths
Proximal CO2 measurement
Evita Link
Interface card
Output of measured values, status messages and
alarm messages to connected equipment for
monitoring, documentation, or further processing.
**
*
Not available on Evita XL Neo
Instructions for Use Evita XL SW 7.0n
Not available for USA, Canada, Japan, China, Taiwan,
Korea, and Brazil
17
Page 18
Application
Monitoring in accordance with the
options used
–
Airway pressure, PAW
–
Expiratory minute volume, MV
–
Inspiratory tidal volume, VTi
–
Inspiratory O2 concentration, FiO2
–
Inspiratory breathing gas temperature, T
–
Apnea time, TApnoea
–
Respiratory rate, fspn
–
End-expiratory CO2 concentration, etCO2
18
Instructions for Use Evita XL SW 7.0n
Page 19
System Overview
System Overview
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . 20
Front Connections . . . . . . . . . . . . . . . . . . . . . 21
Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Evita XL Mobil trolley . . . . . . . . . . . . . . . . . . . 23
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 24
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Instructions for Use Evita XL SW 7.0n
19
Page 20
System Overview
Control Panel
I
A
B
C
D
E
F
G
MT-0071-2008
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
I
Touch-sensitive screen
D Unassigned key for future functions
E
Sensor Parameter key for calibrating
sensors and for switching monitoring on or off
F
System Setup key for configuring device
functions
G
Start/Standby key for switching between
operation and standby mode
1
2
3
H Rotary knob for selecting and confirming
settings
20
Instructions for Use Evita XL SW 7.0n
Page 21
System Overview
Front Connections
B C
D
E
F
G
H
MT-0072-2008
A
A
Gas exhaust port
(EXHAUST – NOT FOR SPIROMETERS)
H Locking screw for protective cover
(behind it: O2 sensor and ambient air filter)
B Flow sensor
C Flow sensor flap
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 SW 7.0n
21
Page 22
System Overview
Back Panel
A
B
C
D
E
Q
F
G
P
O
N
L
K
A Power switch with protective flap
J
B COM 2, COM 3 ports for RS 232, 2 CAN
interfaces and analog interface (optional)
K CO2
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
I
J
Temp
H
socket for temperature sensor
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
H Connection for O2
I
22
Connection for medical air (Air)
Instructions for Use Evita XL SW 7.0n
EvitaXL_back_panel
M
Page 23
System Overview
Evita XL Mobil trolley
A
B
C
D
E
F
G
123
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
Instructions for Use Evita XL SW 7.0n
23
Page 24
System Overview
Abbreviations
Abbreviation
Description
Adult
Option for Evita XL Neo 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
ASB
Assisted Spontaneous Breathing. Pressure-supported spontaneous breathing
ATC
Automatic Tube Compensation
AutoFlow
Special function for automatic regulation of the inspiratory flow during volume-controlled
ventilation, enables free deep breathing
BIPAP
Biphasic Positive Airway Pressure. Ventilation mode for spontaneous breathing at
continuous positive airway pressure with two different pressure levels
BIPAP Assist
Biphasic Positive Airway Pressure Assisted. Ventilation mode for assisted ventilation
with continuous positive airway pressure with two different pressure levels
bpm
Breaths per minute
BTPS
Body Temperature, Pressure, Saturated
Measured values based on the conditions of the patient lungs: body temperature 37 °C
(98.6 °F), water-vapor saturated gas, ambient pressure
C
Compliance
CAN
Controller Area Network
CCP
Critical Closing Pressure
CO2
Comp.
CO2 production [L/min]
Degree of tube compensation (set value)
COPD
Chronic Obstructive Pulmonary Disease
CPAP
Continuous Positive Airway Pressure. Spontaneous breathing with positive airway
pressure
CPAP/ASB
Spontaneous breathing with positive airway pressure and pressure support
CPPV
Continuous Positive Pressure Ventilation
Controlled ventilation with continuous positive airway pressure
Cstat
Static compliance
Δint.PEEP
Intermittent Positive End-Expiratory Pressure (expiratory sigh)
ΔPApnoea
Set value for PApnoea relative to PEEP
ΔPASB
Set value for PASB relative to PEEP
ΔPAW
Pressure support on the tube
EIP
End-inspiratory pressure
EMC
Electromagnetic compatibility
etCO2
End-expiratory CO2 concentration
24
Instructions for Use Evita XL SW 7.0n
Page 25
System Overview
Abbreviation
Description
Ext. Flow
External Flow
f
Respiratory rate in bpm
Fail to cycle
Breathing cycle failure. Ventilator detects no inspiration
fApnoea
Respiratory rate setting for apnea ventilation
FeCO2
Expiratory CO2 concentration
FiO2
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
Flowbf
Basic flow (system setting), see "Power Characteristics" on page 210
Flowexp
Expiratory flow, without leakage correction
Flowinsp
Inspiratory flow, without leakage correction
Flowleak
Current leakage flow
Flowout
Flow through the expiratory valve during inspiration
Flowpatient
Inspiratory/expiratory flow, with leakage correction (measured value)
fmand
Mandatory mechanical portion of overall respiratory rate
fspn
Spontaneous breathing portion of overall respiratory rate
ftotal
Total respiratory rate (fmand + fspn)
ftrig.
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
Insp. term.
PIF[%]
Criterion for the termination of ASB breaths, % of maximum inspiratory flow
(Peak Inspiratory Flow)
IPPV
Intermittent Positive Pressure Ventilation
Intermittent ventilation with positive pressure
IPPVAssist
Trigger-assisted Intermittent Positive Pressure Ventilation
IRV
Inversed Ratio Ventilation. Ventilation with inversed ratio of inspiration/expiration
KG
Body weight [kg]
KTube
Tube coefficient
LIP
Lower Inflection Point
LUST
List-controlled universal interface driver program
MEDIBUS
Dräger communication protocol for medical devices
MMV
Mandatory Minute (Volume) Ventilation
Instructions for Use Evita XL SW 7.0n
25