evita_infinity_v500_instructions_for_use_sw_2-n_edi.pdf
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Instructions for use
Infinity Acute Care System
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Evita Infinity V500
Ventilation unit
SW 2.n
Page 2
Typographical conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
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
related illustration.
A Letters in illustrations denote elements referred
to in the text.
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for
example, PEEP, Air or Alarms.
The "greater than" symbol > indicates the
navigation path in a dialog window, for example,
System setup > Ventilation > Modes. In this
example, System setup represents the dialog
window title, Ventilation represents a horizontally
aligned tab, and Modes a vertically aligned tab.
Screen images
Schematic renderings of screen images are used,
which may differ in appearance or in configuration
from the actual screen images.
Product name used
In these instructions for use, the designation
Evita V500 is used for Evita Infinity V500.
Use of terms
Dräger uses the term "Accessory" not only for
accessories in the sense of IEC 60601-1, but also
for consumable parts, removable parts, and
attached parts.
Trademarks
Trademark
AutoFlow
Infinity
®
®
Trademark owner
Trademark
Trademark owner
Dräger
MEDIBUS.X®
Dräger
Sekusept
®
QuickSet®
Actichlor®
ATC®
Oxycide®
SmartCare®
Acute Care
SystemTM
Medical CockpitTM
DrägerService®
MEDIBUS™
2
Klorsept
Ecolab USA
®
Medentech
BruTab 6S
®
Descogen®
Dispatch
Ecolab
®
®
Dismozon
Brulin
Antiseptica
Clorox
BODE Chemie
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Trademark
Trademark owner
Virkon®
DuPont
Perform®
Mikrozid
Schülke & Mayr
®
Buraton®
acryl-des®
BIPAP1)
1)
Licensed trademark
Safety information 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.
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Definition of the target groups
For this medical device users, service personnel,
and experts are defined as target groups.
Service personnel
These target groups have been instructed in the
use of the medical device and have the necessary
knowledge to use, install, reprocess, maintain or
repair the medical device.
Service personnel are persons who are responsible
for the maintenance of the medical device towards
the operating organization.
Dräger emphasizes that the medical device must
be used, installed, reprocessed, maintained or
repaired exclusively by defined target groups.
Service personnel are persons who may install,
reprocess, or maintain the medical device.
Experts
Experts are persons who may carry out repair or
complex maintenance work on the medical device.
Users
Users are persons who may use the medical device
in accordance with its intended use.
Abbreviations and symbols
For explanations refer to sections "Abbreviations"
and "Symbols" in chapter "System overview".
4
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Contents
Contents
Typographical conventions . . . . . . . . . . . . . . . .
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety information definitions . . . . . . . . . . . . . .
Definition of the target groups . . . . . . . . . . . . .
Abbreviations and symbols. . . . . . . . . . . . . . . .
2
2
3
4
4
For your safety and that of your patients. . .
7
General safety information . . . . . . . . . . . . . . . . 8
Product-specific safety information. . . . . . . . . . 12
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Indications for use and contraindications . . . . . 18
Environment of use. . . . . . . . . . . . . . . . . . . . . . 18
System overview . . . . . . . . . . . . . . . . . . . . . . 19
Infinity Acute Care System – Workstation
Critical Care . . . . . . . . . . . . . . . . . . . . . . . . . . .
Evita V500 ventilation unit . . . . . . . . . . . . . . . .
Trolley 2-90 cm. . . . . . . . . . . . . . . . . . . . . . . . .
GS500 gas supply unit . . . . . . . . . . . . . . . . . .
Range of functions . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
21
23
24
25
27
33
Operating concept . . . . . . . . . . . . . . . . . . . . . 37
Operating concept for Infinity C500 . . . . . . . . . 38
Operating concept for Evita V500 . . . . . . . . . . 38
Assembly and preparation . . . . . . . . . . . . . . 43
Safety information for assembly and
preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparing the trolley . . . . . . . . . . . . . . . . . . . .
Preparing the Medical Cockpit . . . . . . . . . . . . .
Preparing the ventilation unit . . . . . . . . . . . . . .
Intrahospital transport. . . . . . . . . . . . . . . . . . . .
44
44
48
53
66
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 67
Safety information on getting started . . . . . . . .
Switching on Evita V500 and Infinity C500. . . .
Selecting a patient . . . . . . . . . . . . . . . . . . . . . .
Selecting the breathing circuit and the
breathing gas humidifier . . . . . . . . . . . . . . . . . .
68
68
69
Checking readiness for operation . . . . . . . . . . 74
Selecting the Tube or NIV application mode . 83
Transfer of ventilation settings. . . . . . . . . . . . . 84
Selecting the therapy type . . . . . . . . . . . . . . . 85
Starting the therapy . . . . . . . . . . . . . . . . . . . . . 86
Displaying the status of accessories . . . . . . . . 87
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . .
89
Setting ventilation . . . . . . . . . . . . . . . . . . . . . .
NIV – Non-invasive ventilation . . . . . . . . . . . .
Displaying curves and measured values . . . .
Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maneuvers. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication nebulization . . . . . . . . . . . . . . . . .
Measurement maneuver Low Flow PV
Loop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostics – measurement maneuver . . . . .
GS500 gas supply unit . . . . . . . . . . . . . . . . . .
O2 therapy . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standby mode . . . . . . . . . . . . . . . . . . . . . . . . .
Ending operation . . . . . . . . . . . . . . . . . . . . . . .
Storing Evita V500. . . . . . . . . . . . . . . . . . . . . .
Mains power supply / DC power supply . . . . .
Intrahospital patient transport . . . . . . . . . . . . .
91
99
102
106
107
111
119
123
126
127
130
132
133
134
137
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display of alarms. . . . . . . . . . . . . . . . . . . . . . .
Displaying information on alarms . . . . . . . . . .
Alarm history . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting alarm limits . . . . . . . . . . . . . . . . . . . . .
Setting the volume of the alarm tone . . . . . . .
Suppressing the alarm tone . . . . . . . . . . . . . .
Position of the user to the alarm system . . . . .
Failure of the acoustic alarm . . . . . . . . . . . . .
140
140
142
143
144
146
147
147
148
Trends and data . . . . . . . . . . . . . . . . . . . . . . . 149
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Displaying trends . . . . . . . . . . . . . . . . . . . . . .
Displaying data . . . . . . . . . . . . . . . . . . . . . . . .
Displaying the logbook . . . . . . . . . . . . . . . . . .
Data export . . . . . . . . . . . . . . . . . . . . . . . . . . .
150
150
154
155
156
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Contents
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Technical data . . . . . . . . . . . . . . . . . . . . . . . . 277
Information on monitoring. . . . . . . . . . . . . . . . . 158
Flow monitoring . . . . . . . . . . . . . . . . . . . . . . . . 159
O2 monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 164
CO2 monitoring. . . . . . . . . . . . . . . . . . . . . . . . . 165
Ambient conditions . . . . . . . . . . . . . . . . . . . . .
Set values . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performance characteristics . . . . . . . . . . . . . .
Displayed measured values . . . . . . . . . . . . . .
Displayed calculated values . . . . . . . . . . . . . .
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating data. . . . . . . . . . . . . . . . . . . . . . . . .
Device ports . . . . . . . . . . . . . . . . . . . . . . . . . .
Automatic alarm limits . . . . . . . . . . . . . . . . . . .
Essential performance characteristics. . . . . . .
Connections to IT networks. . . . . . . . . . . . . . .
Open-source software . . . . . . . . . . . . . . . . . . .
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 173
Information on configuration. . . . . . . . . . . . . . . 174
Configuring the screen display . . . . . . . . . . . . 174
Configuring alarm settings . . . . . . . . . . . . . . . . 183
Configuring ventilation settings . . . . . . . . . . . . 186
Importing and exporting configurations . . . . . . 195
Installing applications . . . . . . . . . . . . . . . . . . . . 197
System status . . . . . . . . . . . . . . . . . . . . . . . . . . 198
System settings . . . . . . . . . . . . . . . . . . . . . . . . 200
Service dialog. . . . . . . . . . . . . . . . . . . . . . . . . . 203
Alarm – Cause – Remedy . . . . . . . . . . . . . . . 205
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 243
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Information on reprocessing. . . . . . . . . . . . . . . 248
Classifications for reprocessing . . . . . . . . . . . . 250
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 251
Reprocessing procedure . . . . . . . . . . . . . . . . . 253
After reprocessing . . . . . . . . . . . . . . . . . . . . . . 259
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
Preventive maintenance. . . . . . . . . . . . . . . . . . 266
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Replacing the ambient air filter. . . . . . . . . . . . . 267
Replacing the diaphragm of the expiratory
valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Replacing the expiratory valve . . . . . . . . . . . . . 268
Preventive maintenance on the GS500 gas
supply unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
Battery maintenance . . . . . . . . . . . . . . . . . . . . 270
278
279
283
286
291
292
296
301
302
305
306
307
Principles of operation . . . . . . . . . . . . . . . . . 309
Description of the ventilation modes . . . . . . . .
Additional settings for ventilation. . . . . . . . . . .
Special functions . . . . . . . . . . . . . . . . . . . . . . .
Description of the therapy types . . . . . . . . . . .
Automatic leakage compensation . . . . . . . . .
Flow reduction Anti Air Shower . . . . . . . . . . . .
Measurements. . . . . . . . . . . . . . . . . . . . . . . . .
Battery concept . . . . . . . . . . . . . . . . . . . . . . . .
Pneumatic functional description . . . . . . . . . .
Main menu bar structure . . . . . . . . . . . . . . . . .
Factory-set screen views. . . . . . . . . . . . . . . . .
List of references . . . . . . . . . . . . . . . . . . . . . .
310
332
345
353
354
355
356
359
363
366
371
372
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 375
Password for Evita V500 SW 2.n . . . . . . . . . 381
Information on the password . . . . . . . . . . . . 381
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Safety information on disposal . . . . . . . . . . . . . 274
Disposal of packaging material . . . . . . . . . . . . 274
Disposal of batteries. . . . . . . . . . . . . . . . . . . . . 275
Disposal of flow sensor and neonatal flow
sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
Disposal of medical devices . . . . . . . . . . . . . . . 275
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For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . .
8
Strictly follow these instructions for use . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Safe connection to other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Device combinations . . . . . . . . . . . . . . . . . . . .
Connection to IT network . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Information on electromagnetic compatibility . .
Disposable articles . . . . . . . . . . . . . . . . . . . . . .
Sterile accessories . . . . . . . . . . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
8
8
8
9
9
9
9
10
10
10
11
11
11
11
11
12
Product-specific safety information . . . . . . . 12
Monitoring ventilation . . . . . . . . . . . . . . . . . . . . 14
Back-up ventilation with an independent
manual ventilation device . . . . . . . . . . . . . . . . . 14
Handling Infinity ID components. . . . . . . . . . . . 15
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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For your safety and that of your patients
General safety information
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this device.
Strictly follow these instructions for use
WARNING
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the
purpose specified under "Intended use"
on page 18 and in conjunction with
appropriate patient monitoring (see page 10).
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety
information statements constitutes a use of
the medical device that is inconsistent with its
intended use.
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by service personnel.
Repairs or complex maintenance work carried
out on the medical device must be performed
by experts.
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService.
Dräger recommends that only genuine Dräger
parts are used for maintenance.
If the above are not complied with, the correct
functioning of the medical device may be
compromised.
Observe chapter "Maintenance".
Safety checks
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Accessories
WARNING
Only the accessories indicated on the list of
accessories 9039085 (2nd edition or later)
have been tested and approved for use with
the medical device.
Therefore, it is strongly recommended that
only these accessories are used in
conjunction with the medical device.
Otherwise, the correct functioning of the
medical device may be compromised.
8
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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For your safety and that of your patients
Not for use in areas of explosion hazard
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 to other electrical
equipment
WARNING
Risk of patient injury
Electrical connections to equipment not listed
in these instructions for use or these
assembly instructions must only be made
when approved by each respective
manufacturer.
Connected devices
WARNING
Risk of electric shock and of device
malfunction
Any connected devices or device
combinations not complying with the
requirements mentioned in these instructions
for use may compromise the correct
functioning of the medical device. Before
operating the medical device, strictly comply
with the instructions for use of all connected
devices or device combinations.
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying
documents of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional state of the individual
devices may be compromised. The operating
organization must ensure that the device
combination complies with the applicable editions
of the relevant standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards:
– IEC˽60601-1, 3rd˽edition (general
requirements for safety, device combinations,
software-controlled functions)
– IEC˽60601-1-2 (electromagnetic
compatibility)
– IEC˽60601-1-8 (alarm systems)
Or:
– IEC˽60601-1, 2nd˽edition (general
requirements for safety)
– IEC˽60601-1-1 (device combinations)
– IEC˽60601-1-2 (electromagnetic
compatibility)
– IEC˽60601-1-4 (software-controlled
functions)
– IEC˽60601-1-8 (alarm systems)
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Page 10
For your safety and that of your patients
Connection to IT network
The connection of the medical device to a network
or later changes in the network can result in
previously unidentified risks for patients, users and
third parties. These risks must be identified and
controlled before putting the medical device into
operation.
Relevant changes to the network include:
– Configuration changes
– Adding or removing additional equipment
– Update or upgrade of connected devices
Risks
Overloading of the medical device as a result of
very high network traffic (e.g., due to "denial of
service" attacks) could lead to deactivation of the
interfaces. The service functionality would not then
be available until the medical device has been
restarted. In rare cases, a warm boot may take
place and may occur repeatedly.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
Patient monitoring
The user of the medical device is responsible for
choosing suitable monitoring that provides
appropriate information about medical device
performance and the patient's condition.
Patient safety may be achieved by 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 selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Patient safety
The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to persons familiar with the most
important inherent characteristics of the medical
device. Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
These instructions for use do not contain
references to various hazards which are obvious to
users or references to the consequences of
medical device misuse, or to potentially adverse
effects in patients with different underlying
diseases. Medical device modification or misuse
can be dangerous.
10
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For your safety and that of your patients
Information on electromagnetic
compatibility
General information on electromagnetic
compatibility (EMC) according 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 in the separate
instructions for use "Workstation Critical Care and
Workstation Neonatal Care".
Portable and mobile RF communications
equipment can affect medical electrical equipment.
WARNING
Do not connect connectors with an ESD
warning symbol and do not touch the pins of
such connectors without implementing ESD
protective measures. Such protective
measures may include antistatic clothing and
shoes, touching a ground stud before and
during connection of the pins, or using
electrically insulating and antistatic gloves.
All relevant personnel must be instructed in
these ESD protective measures.
WARNING
Do not use portable and mobile HF
communications equipment, e.g., mobile
phones, in the vicinity of the medical device.
Maintain separation distances; see EMC
information in the separate instructions for
use, "Workstation Critical Care and
Workstation Neonatal Care".
Disposable articles
WARNING
Risk of patient injury as a result of failure of
the accessories
Disposable articles were developed, tested
and manufactured for single use only. Reuse,
reprocessing or sterilization can lead to a
failure of the accessories and cause injuries
to the patient.
Do not reuse, reprocess, or sterilize
disposable articles.
Sterile accessories
CAUTION
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged, or if
there are other signs of non-sterility.
Installing accessories
CAUTION
Install accessories to the basic device in
accordance with the instructions for use of the
basic device. Make sure that there is a safe
connection to the basic device system.
Strictly observe instructions for use and assembly
instructions.
Storing the instructions for use
CAUTION
The instructions for use must be kept in an
accessible location for users.
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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For your safety and that of your patients
Training
Training for users is available from the Dräger
organization responsible, see www.draeger.com.
Product-specific safety information
WARNING
This medical device is intended to be used
only by trained users.
WARNING
Risk of fire
The flow sensor can ignite medications or
other substances based on highly flammable
substances.
– Do not nebulize medications or other
substances that are easily flammable or
spray them into the device.
– Do not use substances containing alcohol.
– Do not allow flammable or explosive
substances to enter the breathing system
or the breathing circuit.
WARNING
Risk of fire
WARNING
Do not use the medical device in hyperbaric
chambers! This may impair correct
functioning of the medical device and
endanger the patient.
WARNING
Correct functioning of the medical device may
be impaired by operation of high-frequency
electrosurgery units, defibrillators or shortwave therapy equipment and endanger the
patient.
WARNING
Risk of malfunction
Unauthorized modifications to the medical
device lead to malfunctions.
This medical device must not be modified
unless authorized by the manufacturer.
Do not use the medical device in conjunction
with flammable gases or flammable solutions
that can mix with air, oxygen or nitrous oxide,
or other sources of ignition since the medical
device could ignite. Do not allow the medical
device to come into contact with sources of
ignition.
WARNING
Risk of electric shock
Live components are located under the cover.
Do not open the housing of the medical
device.
WARNING
Do not use the medical device during
magnetic resonance imaging (MRI, NMR,
NMI)! This may impair correct functioning of
the medical device and endanger the patient.
12
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 13
For your safety and that of your patients
WARNING
Risk of fire
Do not use the medical device in oxygenenriched rooms since the medical device
could ignite.
Medical device malfunctions can increase the
O2 concentration in the ambient air. The
medical device is only suitable for use in
rooms with sufficient ventilation.
WARNING
Do not obstruct the gas inlet for the safety
valve. Otherwise, spontaneous breathing via
the emergency breathing valve is not possible
in the event of a device failure.
WARNING
With neonates, the administration of
increased O2 concentrations can lead to
retinopathy of prematurity.
Use additional monitoring, e.g., external SpO2.
WARNING
Risk of fire
The use of unapproved O2 pressure reducers
can lead to excess pressure which can cause
a fire.
When supplying the ventilator with oxygen
from a compressed gas cylinder, only use
pressure reducers compliant with ISO 10524.
Slowly open the pressure reducer manually.
Do not use tools.
WARNING
Risk of unnoticed change in inspiratory O2
concentration
If an additional flow is delivered by an external
flow source, the actual O2 concentration
delivered may deviate from the displayed
values.
Use additional monitoring, e.g., external SpO2
monitoring, if necessary.
WARNING
Risk of patient injury
If leakages are present, e.g., with non-invasive
ventilation, the actual tidal volume may
deviate from the measured values for VTe and
VTi.
Activate leakage compensation and monitor
the measured value for VT. Minimize or
remedy all leakages.
WARNING
Risk of failure of flow measurement
Deposits that were not removed during
reprocessing can damage the measuring
wires in the flow sensor or cause a fire.
– Before inserting the flow sensor check for
visible damage, soiling, and particles.
Repeat this check regularly.
– Replace flow sensors when damaged,
soiled, or not particlefree.
CAUTION
Keep away from sources of heat such as direct
sunlight, heat radiators or spotlights! Otherwise
the medical device may become too hot.
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Page 14
For your safety and that of your patients
CAUTION
Do not obstruct or close off the vents on the
medical device. Air must be able to enter freely.
Otherwise the medical device may become too
hot. An alarm is triggered if the medical device
overheats during operation.
CAUTION
Positive-pressure ventilation can lead to negative
effects, such as barotrauma or strain on the
circulatory system.
CAUTION
Risk of patient injury
An additional flow delivered by an external flow
source can affect the measured values for airway
pressure and flow.
Monitoring ventilation
The following parameters are monitored by the
built-in monitoring facilities of Evita V500:
– Airway pressure
– Expiratory minute volume
– Inspiratory tidal volume
– Respiratory rate
– Apnea alarm time
– Inspiratory O2 concentration
– End-expiratory CO2 concentration
Changes in these parameters may be caused by:
– Acute changes in the patient's condition
– Incorrect settings and faulty handling
– Device malfunctions
– Failure of power and gas supplies
If a fault occurs in this equipment, separate
measuring instruments must be used.
During O2 therapy, the monitoring functions of the
medical device are restricted. See chapter "O2
therapy" on page 127.
CAUTION
Risk of malfunction
The touch screen has a sensitive surface.
Damage to the surface may cause the touchsensitive controls not to work properly.
Do not operate the screen with sharp objects.
Back-up ventilation with an independent
manual ventilation device
WARNING
If a fault is detected in the medical device, its
life-support functions may no longer be
assured. Ventilation of the patient using an
independent ventilation device must be
started without delay, if necessary with PEEP
and/or an increased inspiratory O2
concentration (e.g., with a manual
resuscitator).
14
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 15
For your safety and that of your patients
Handling Infinity ID components
Through ownership or purchase of this medical
device equipped with RFID technology, you have
only acquired the right to use the medical device
and RFID technology in conjunction with products
approved by Dräger and in strict compliance with
these instructions for use. No intellectual property
rights or any rights to the use of the medical device
or RFID technology are hereby granted, either
explicitly or implicitly, which are contrary to the
above-mentioned conditions.
WARNING
Risk of patient injury
The RFID system of this medical device complies
with Part 15 of the FCC regulations, and its
operation is subject to the following conditions:
1
This medical device does not cause any
dangerous interference.
2
The medical device is not liable to damage
caused by the reception of interference,
including interference causing undesired
operating conditions.
Dräger hereby declares that the RFID system in the
ventilation unit is in compliance with the basic
requirements and the other pertinent regulations of
Directive 1999/5/EC.
Although Evita V500 does not exceed the
applicable limiting values for electromagnetic
fields, radiation can interfere with the
functioning of pacemakers. Wearers of
pacemakers must keep a distance of at least
25 cm (10 in) between the pacemaker and
Evita V500.
Emission of high-frequency energy
This medical device is equipped with an RFID
(Radio Frequency Identification) system to enable
wireless communication with Infinity ID
accessories. Any changes or modifications to the
RFID system may only be carried out by experts.
Otherwise this may compromise patient safety.
This medical device has been designed and
manufactured to comply with emission limit values
for high-frequency energy. These limiting values
are incorporated in international safety standards
such as IEC 60601-1-2 (EN 60601-1-2) which have
been defined by regulation authorities, such as the
Federal Communications Commission
(FCC Rules), Industry Canada (Radio Standards
Specifications) and the European
Telecommunications Standards Institute
(ETSI standards).
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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16
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 17
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Indications for use and contraindications . . 18
Environment of use . . . . . . . . . . . . . . . . . . . . 18
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Application
Intended use
The Evita V500 ventilation unit of the
Infinity Acute Care System is intended for the
ventilation of adults, pediatric patients and
neonates. Evita V500 provides mandatory
ventilation modes and ventilation modes for
supporting spontaneous breathing and also airway
monitoring. The Evita V500 ventilation unit is used
with Dräger Infinity C Series Medical Cockpits. The
Evita V500 ventilation unit is intended for use in
different medical care areas.
Indications for use and contraindications
Indications
The Evita V500 ventilation unit is used in
combination with Dräger Infinity C Series Medical
Cockpits. Evita V500 is used for treating patients
who require temporary or longer term respiratory
support for different medical reasons.
It is the responsibility of the user to select the
appropriate respiratory mode for the underlying
disease of the patient. For all ventilator settings, the
user needs to consider the respiratory status and
the general state of health of the patient in order to
optimally adapt the ventilation settings to the
patient's condition. Any changes to the patient's
state need to be monitored continuously.
Contraindications
There are no additional contraindications apart
from the contraindications contained in chapter
"For your safety and that of your patients".
Environment of use
Evita V500 is intended for stationary use in
hospitals and medical rooms or for patient
transportation within the hospital.
–
In rooms without sufficient ventilation
Do not operate the device with helium or helium
mixtures.
Do not use the device in the following
environments:
– In hyperbaric chambers
– For magnetic resonance imaging (MRI, NMR,
NMI)
– In conjunction with flammable gases or
flammable solutions that can mix with air,
oxygen or nitrous oxide
– In areas of explosion hazard
– In areas with combustible or explosive
substances
18
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 19
System overview
System overview
Infinity Acute Care System – Workstation
Critical Care . . . . . . . . . . . . . . . . . . . . . . . . . . 20
How to use the Workstation Critical Care. . . . . 20
Evita V500 ventilation unit . . . . . . . . . . . . . . . 21
Front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Back panel . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Left side view . . . . . . . . . . . . . . . . . . . . . . . . . .
Right side view . . . . . . . . . . . . . . . . . . . . . . . . .
21
22
22
23
Trolley 2-90 cm . . . . . . . . . . . . . . . . . . . . . . . . 23
GS500 gas supply unit . . . . . . . . . . . . . . . . . . 24
Back panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Range of functions . . . . . . . . . . . . . . . . . . . . . 25
Ventilation functions of Evita V500 . . . . . . . . . .
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication nebulizer. . . . . . . . . . . . . . . . . . . . .
Attaching accessories. . . . . . . . . . . . . . . . . . . .
25
26
26
26
26
26
26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 27
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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Page 20
System overview
Infinity Acute Care System – Workstation Critical Care
How to use the Workstation Critical Care
The Workstation Critical Care can consist of the
following units:
– Infinity C500 (Medical Cockpit)
– Evita V500 (ventilation unit)
– Trolley 2-90 cm (trolley)
– GS500 (gas supply unit)
– PS500 (power supply unit)
– Transport Supply Unit (transport supply unit)
A
Before using the Workstation Critical Care,
carefully read the following instructions for use:
– Instructions for use for "Workstation Critical
Care and Workstation Neonatal Care"
– Instructions for use for "Infinity Medical
Cockpits"
– Instructions for use for "Evita Infinity V500"
– Instructions for use for "Transport Supply Unit"
B
The Workstation Critical Care may include
additional accessories, see separate list of
accessories.
C
D
001
E
A Infinity C500 – Control and display unit (Medical
Cockpit). Strictly follow the instructions for use
for "Infinity Medical Cockpits".
B Evita V500 – Ventilation unit
C GS500 – Gas supply unit
D PS500 – Power supply unit
E Trolley 2-90 cm – Trolley
20
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 21
System overview
Evita V500 ventilation unit
Front panel
Front view, flap folded upwards
Front view, flap closed
A
B
G
H
I
F
C
D
J
070
071
E
A Operation display of ventilation
During ventilation, the inspiratory and
expiratory phases are indicated by a bar
display. The measured values for minute
volume MVe and the inspiratory O2
concentration FiO2 are also displayed.
G Infinity ID flow sensor
In the Neo. patient category: Muffler
H Gas outlet Exhaust, non-tapered connection
(EXHAUST – NOT FOR SPIROMETER)
I
Connections for future extensions
J
Nebulizer port (nebulizer gas outlet for
pneumatic medication nebulizer)
B Infinity ID expiratory valve with expiratory port
In the Neo. patient category: Infinity ID
neonatal expiratory valve with expiratory port
Exp. (GAS RETURN)
C Inspiratory unit (safety valve with inspiratory
port) Insp. (GAS OUTPUT)
D Gas inlet for the Emergency air intake safety
valve, non-tapered connection, do not obstruct
(EMERGENCY AIR INTAKE)
E Water trap
F Flap
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
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System overview
Back panel
Left side view
A
B
C
D
E
F
G
005
004
A
B
C
D
E
F
G
A Fuse for the batteries
B Connection for the neonatal flow sensor V5
C Connections for future extensions V6, V8
D Connection for CO2 sensor V7
A Connection for system cable to Infinity C500 V1
B Connections for future extensions V2, V3
C Connection for nurse call V4
D Toggle switch
E Potential equalization pin
F Fuse for mains power supply F1, F2
G Connection for mains power supply
E Ambient air filter with cover
F Strain relief for cable
G Left device flap
22
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 23
System overview
Right side view
A Connection for data cable to the GS500 gas
supply unit V9
A
B Connection for gas connection to the GS500
gas supply unit
C Connection for Air compressed gas hose Air
(FRESH GAS)
B
C
D Connection for O2 compressed gas hose O2
(FRESH GAS)
D
E Right device flap
014
E
Trolley 2-90 cm
A Mount for Infinity C500
B Handle
A
C Trolley column
B
D Hose hooks
E Alignment aid
C
D
E
F
F Humidifier holder, can be swiveled
G Universal holder with standard rail
H Double castors with locking brake, set of 4
D
G
038
H
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Page 24
System overview
GS500 gas supply unit
Back panel
C
C
A
C
C
330
B
A Rating plate
B Gas connection
C Screws (to hold the side panels in place)
24
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
Page 25
System overview
Range of functions
The functions described correspond to the overall
functionality of Evita V500. Some functions are only
optional and may not be included in the individual
device configuration. Optional functions are shown
in the separate list of accessories.
Ventilation functions of Evita V500
Ventilation modes:
– Volume-controlled ventilation:
– VC-SIMV
– VC-AC
– VC-CMV
– VC-MMV
– Pressure-controlled ventilation:
– PC-SIMV
– PC-BIPAP
– PC-AC
– PC-CMV
– PC-APRV
– PC-PSV
– Support of spontaneous breathing:
– SPN-CPAP/PS
– SPN-CPAP/VS
– SPN-PPS
Special functions:
– Maneuvers:
– Manual inspiration/hold
– Exp. hold
– Suction maneuver
– Manual disconnection
– Medication nebulization
– Measurement maneuver Low Flow PV Loop
– Diagnostics – measurement maneuver
– Intrinsic PEEP measurement
– Occlusion pressure measurement
– NIF measurement
Therapy types:
– Invasive ventilation (Tube)
– O2 Therapy
– Non-invasive ventilation (NIV)
Additional information
For a detailed description of the ventilation modes
and the additional settings see page 310.
Abbreviations see page 27.
Additional settings for ventilation:
– Apnea Ventilation
– Flow trigger
– Inspiratory termination
– Sigh
– AutoFlow
– Volume Guarantee
– ATC
– AutoRelease
– Variable PS
– SmartCare/PS
Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n
25