Evita V800 / V600

Intensive care ventilator

Software 1.n

Instructions for use

WARNING
To properly use this medical device, read and comply
with these instructions for use.
Evita V800 / V600
 This page has been left blank intentionally.

2 Instructions for use | Evita V800 / V600 SW 1.n

 Contents

Contents
Evita V800
Intensive care
/ V600
ventilator

1 Information about this document ........................................................... 7

1.1 Typographical conventions ............................................................. 7
1.2 Use of terms ................................................................................... 7
1.3 Illustrations...................................................................................... 7
1.4 Additional documents ..................................................................... 7
1.5 Trademarks..................................................................................... 8

2 Safety-related information....................................................................... 9
2.1 Intended use ................................................................................... 9
2.2 Indications....................................................................................... 9
2.3 Contraindications ............................................................................ 9
2.4 Environments of use ....................................................................... 9
2.5 Essential performance characteristics ............................................ 10
2.6 User group requirements ................................................................ 10
2.7 Information on safety instructions and precautionary statements... 11
2.8 Safety instructions .......................................................................... 12
2.9 Further information ......................................................................... 17

3 Overview ................................................................................................... 18
3.1 Intensive care ventilator.................................................................. 18
3.2 Display unit ..................................................................................... 19
3.3 Ventilation unit ................................................................................ 21
3.4 Trolley ............................................................................................. 25
3.5 GS500 gas supply unit.................................................................... 26
3.6 Range of functions.......................................................................... 26
3.7 Abbreviations .................................................................................. 29
3.8 Symbols .......................................................................................... 36
3.9 Product labels ................................................................................. 40

4 Operating concept.................................................................................... 41
4.1 Screen ............................................................................................ 41
4.2 Using the screen............................................................................. 45
4.3 Setting the ventilation ..................................................................... 51
4.4 Operating the monitoring area ........................................................ 54
4.5 Using the help function ................................................................... 57

5 Assembly and preparation ...................................................................... 59

5.1 Safety instructions .......................................................................... 59
5.2 Maximum loads............................................................................... 63
5.3 Attaching and adjusting the holders and accessories..................... 64
5.4 Attaching compressed gas cylinders to the trolley.......................... 67
5.5 Preparing the display unit ............................................................... 69
5.6 Preparing the ventilation unit .......................................................... 73
5.7 Establishing the power supply ........................................................ 82
5.8 Checking the main switch ............................................................... 84
5.9 Connecting the potential equalization cable ................................... 84
5.10 Establishing the gas supply ............................................................ 85
5.11 Connecting the nurse call ............................................................... 85

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Contents

5.12 Closing the lateral device flaps ....................................................... 86

5.13 Intrahospital device transport.......................................................... 87

6 Getting started.......................................................................................... 88
6.1 Safety instructions .......................................................................... 88
6.2 Turning on the device ..................................................................... 89
6.3 Checking operational readiness ..................................................... 90
6.4 Selecting the therapy type .............................................................. 101
6.5 Admitting a new patient .................................................................. 102
6.6 Starting the therapy ........................................................................ 104

7 Operation .................................................................................................. 106

7.1 Safety instructions .......................................................................... 106
7.2 Ventilation settings.......................................................................... 110
7.3 Changing the therapy type during therapy...................................... 113
7.4 Changing the body weight during ventilation .................................. 114
7.5 Non-invasive ventilation (NIV) ........................................................ 115
7.6 Apnea ventilation ............................................................................ 116
7.7 Loops .............................................................................................. 117
7.8 Smart Pulmonary View ................................................................... 118
7.9 Maneuvers ...................................................................................... 119
7.10 Medication nebulization .................................................................. 122
7.11 Measurement maneuver Low-flow PV loop .................................... 130
7.12 Diagnostics – measurement maneuver .......................................... 137
7.13 GS500 gas supply unit.................................................................... 140
7.14 Intrahospital patient transport ......................................................... 141
7.15 O2 therapy ...................................................................................... 143
7.16 Interrupting therapy – standby mode .............................................. 145
7.17 Battery operation ............................................................................ 146

8 Ending operation...................................................................................... 150

8.1 Shutting down the device................................................................ 150
8.2 Interrupting the gas supply ............................................................. 151
8.3 Storing the device ........................................................................... 151
8.4 Disassembly ................................................................................... 152

9 Alarms ....................................................................................................... 157

9.1 Display of alarms ............................................................................ 157
9.2 Alarm logbook................................................................................. 158
9.3 Confirming alarm messages ........................................................... 159
9.4 Alarm limits ..................................................................................... 160
9.5 Setting the alarm volume ................................................................ 162
9.6 Alarm silence .................................................................................. 163
9.7 Alarm delay..................................................................................... 164
9.8 Alarm system behavior during power supply failure or after turning
off the device .................................................................................. 164

10 Trends ....................................................................................................... 165

10.1 Opening the dialog.......................................................................... 165
10.2 Displaying trends ............................................................................ 165

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10.3 Displaying current values................................................................ 168

10.4 Displaying the logbook.................................................................... 168
10.5 Displaying the test results............................................................... 169
10.6 Performing a data export ................................................................ 170

11 Monitoring................................................................................................. 172
11.1 Safety instructions .......................................................................... 172
11.2 Information on monitoring ............................................................... 173
11.3 Flow monitoring .............................................................................. 174
11.4 O2 monitoring.................................................................................. 178
11.5 CO2 monitoring ............................................................................... 180

12 Configuration............................................................................................ 185
12.1 Safety instructions .......................................................................... 185
12.2 Information on configuration ........................................................... 185
12.3 Configuring the screen display ....................................................... 186
12.4 Configuring the alarm settings ........................................................ 192
12.5 Configuring ventilation settings....................................................... 192
12.6 Configuring the start settings .......................................................... 194
12.7 Importing and exporting configurations........................................... 198
12.8 Activating software options ............................................................. 199
12.9 Performing and configuring the battery test.................................... 200
12.10 Changing the system settings......................................................... 201

13 Troubleshooting ....................................................................................... 204

13.1 Displaying alarm messages............................................................ 204
13.2 Confirming alarm messages ........................................................... 204
13.3 Alarm – Cause – Remedy............................................................... 205

14 Service ...................................................................................................... 229

14.1 Safety instructions .......................................................................... 229
14.2 Prerequisites................................................................................... 229
14.3 Definition of service terminology..................................................... 230
14.4 Inspection ....................................................................................... 230
14.5 Maintenance ................................................................................... 231
14.6 Repair ............................................................................................. 232
14.7 Replacing the room air filter............................................................ 232
14.8 Replacing the diaphragm of the expiratory valve............................ 232
14.9 Replacing the expiratory valve........................................................ 233
14.10 Maintenance of the gas supply unit GS500 .................................... 233
14.11 Battery maintenance....................................................................... 234

15 Disposal .................................................................................................... 239

15.1 Safety instructions .......................................................................... 239
15.2 Disposing of the device................................................................... 239
15.3 Disposing of the packaging material............................................... 239
15.4 Disposing of the batteries ............................................................... 239
15.5 Disposing of the flow sensors ......................................................... 239

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Contents

16 Technical data .......................................................................................... 240

16.1 Ambient conditions ......................................................................... 240
16.2 Set values ....................................................................................... 241
16.3 Performance characteristics ........................................................... 245
16.4 Displayed measured values............................................................ 247
16.5 Displayed calculated values ........................................................... 252
16.6 Monitoring ....................................................................................... 253
16.7 Operating characteristics ................................................................ 256
16.8 Interfaces and ports ........................................................................ 260
16.9 Measurements and weight.............................................................. 261
16.10 Automatic alarm limits..................................................................... 263
16.11 Device combinations....................................................................... 266
16.12 EMC declaration ............................................................................. 266
16.13 Connections to IT networks ............................................................ 268
16.14 Open-source software .................................................................... 271

17 Principles of operation ............................................................................ 272

17.1 Ventilation modes ........................................................................... 272
17.2 Additional settings for ventilation .................................................... 291
17.3 Maneuvers ...................................................................................... 303
17.4 Smart Pulmonary View ................................................................... 309
17.5 Therapy types ................................................................................. 310
17.6 Leakage adaptation and leakage compensation ............................ 311
17.7 Linking the maximum airway pressure to the upper alarm limit –
Pmax/Paw high autoset .................................................................. 313
17.8 Flow reduction – Anti-air shower .................................................... 314
17.9 Measurements ................................................................................ 314
17.10 Battery concept............................................................................... 317
17.11 Pneumatic functional description .................................................... 321
17.12 Menu structure................................................................................ 323
17.13 List of references ............................................................................ 326

18 Password .................................................................................................. 329

18.1 User password for Evita V800 / V600 Software 1.n........................ 329
18.2 Information about the user password ............................................. 329

Index .......................................................................................................... 331

6 Instructions for use | Evita V800 / V600 SW 1.n

 Information about this document

1 Information about this document

1.1 Typographical conventions
Text Bold, italicized texts indicate labels on the device and screen texts.
1. Numbers followed by a period indicate individual action steps in a
sequence of actions. Numbering begins with the number 1 for each new
sequence of actions.
a. Lowercase letters followed by a period indicate subordinate action steps.
Numbering begins anew with the letter a. for each new subordinate action
step.
● This bullet point indicates individual process steps with no specific
sequence.
► This triangle in safety instructions and precautionary statements indicates
ways to avoid danger.
(1) Numbers in parentheses refer to elements in figures.
1 Numbers in figures indicate elements referred to in the text.
– Dashes indicate listings.
> The greater-than symbol indicates the navigation path in a dialog.
This symbol indicates information that makes it easier to use the product.
 This arrow indicates the result of an action step.
✓ This check mark indicates the result of a sequence of actions.

1.2 Use of terms

Dräger uses the term "accessories" not only for accessories in the sense of
IEC 60601-1, but also for consumables, removable parts, and attached parts.
The products "Evita V800" and "Evita V600" are also referred to as "Evita".

1.3 Illustrations
Illustrations of products and screen content in this document may differ from the
actual products depending on configuration and design.
The figures display the product "Evita V800". The information they contain also
applies to the product "Evita V600".

1.4 Additional documents

The reprocessing for this product is described in the separate reprocessing
instructions delivered with the product.

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Information about this document

1.5 Trademarks
1.5.1 Trademarks owned by Dräger
Trademark
Evita®
SmartCare®
ATC®
AutoFlow®
QuickSet®
Infinity®
MEDIBUS®
MEDIBUS.X®

The following web page provides a list of the countries in which the trademarks are
registered: www.draeger.com/trademarks

1.5.2 Trademarks owned by third-party manufacturers

Trademark used Trademark owner
under license
BIPAP Respironics

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 Safety-related information

2 Safety-related information
2.1 Intended use
The intensive care ventilator Evita is intended for the ventilation of adults, pediatric
patients and neonates. This device provides mandatory ventilation modes and
ventilation modes for supporting spontaneous breathing as well as ventilation
monitoring.

2.2 Indications
The device is used for treating patients who require temporary or longer-term
respiratory support for different medical reasons.

2.3 Contraindications
There are no additional contraindications apart from the contraindications contained
in the sections on safety instructions.
It is the responsibility of the user to select the appropriate ventilation 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 condition need to be monitored continuously.

2.4 Environments of use

The device is intended for stationary use in hospitals and medical rooms or for
intrahospital patient transport.
Do not use the device in the following environments of use:
– Hyperbaric chambers
– Magnetic resonance imaging
– Together with flammable gases or flammable solutions that can mix with air,
oxygen, or nitrous oxide
– Areas with danger of explosion
– Areas with combustible and highly flammable substances
– Rooms with insufficient ventilation
Do not operate the device with helium or helium mixtures.

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Safety-related information

2.5 Essential performance characteristics

If the essential performance characteristics function correctly, this guarantees that
the product can be used in accordance with its intended use. The product has the
following essential performance characteristics:
– Controlled and monitored ventilation with settings defined by the user for the
following monitoring functions:
– Minimum and maximum tidal volume
– Maximum airway pressure
– Minimum and maximum O2 concentration in the breathing gas
– If one of the set limits is exceeded, a corresponding alarm is issued.
Additionally, the integrated monitoring issues an alarm in the following situations:
– Failure of the external power supply
– Battery discharge
– Failure of the gas supply

2.6 User group requirements

The term "user group" describes the personnel responsible who have been
assigned by the operating organization to perform a particular task on a product.

2.6.1 Duties of the operating organization

The operating organization must ensure the following:
– Every user group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant chapters in this
document.

2.6.2 User groups

Clinical users
This user group operates the product in accordance with the intended use.
Users have medical specialist knowledge in the field of ventilation. Users have
knowledge of device monitoring and ventilation care.

Reprocessing personnel
This user group carries out the necessary activities to reprocess the product.
Reprocessing personnel has specialist knowledge in the reprocessing of medical
devices.

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 Safety-related information

Service personnel
This user group installs the product and performs the service activities.
Service personnel has specialist knowledge in electrical and mechanical
engineering and experience in the servicing of medical devices.
Where product specific knowledge or tools are required, the service activities must
be carried out by specialized service personnel. The specialized service personnel
was trained by Dräger for these service activities on this product.

2.7 Information on safety instructions and precautionary

statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.

2.7.1 Safety instructions

This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.

2.7.2 Precautionary statements

Precautionary statements relate to action steps and warn of risks that may arise
when performing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.

Warning sign Signal word Consequences of non-compliance

WARNING May result in death or serious injury.
CAUTION May result in moderate or minor injury.
NOTICE May result in property damage.

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Safety-related information

2.8 Safety instructions

2.8.1 Instructions for use
Failure to use the product in accordance with the information contained in these
instructions for use may result in personal injury and property damage.
► Follow these instructions for use.
► Use this product only according to its intended use.
► Keep these instructions for use close to hand.
► Follow these instructions for use and those for any products used in conjunction
with this product.
The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potentially negative effects on patients with one or more illnesses

2.8.2 Symbols and product labels

Failure to observe symbols and product labels may result in personal injury and
property damage.
► Observe the symbols and product labels.

2.8.3 Monitoring the patient's condition

Monitoring of a patient's condition can range from direct observation to electronic
monitoring by means of medical devices. The patient may be put at risk if his or her
condition is not adequately monitored.
► Monitor the patient's condition by suitable means and at appropriate intervals.

2.8.4 Monitoring
Integrated monitoring
The integrated monitoring uses certain parameters to monitor the therapy (see
"Monitoring functions of ventilation monitoring", page 28).
The following factors may cause changes to these parameters:
– Acute changes in the patient's condition
– Incorrect settings and faulty handling
– Device malfunction
– Failure of the power supply and the gas supply
► If a fault occurs in the integrated monitoring, use separate measuring
instruments.

Monitoring during O2 therapy

During O2 therapy, the monitoring functions of the medical device are limited.
► Observe the following information: "O2 therapy", page 143.

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 Safety-related information

2.8.5 Standby mode

Ventilation does not take place in standby mode. If connected, the patient may be
put at risk.
► Connect the patient only after the therapy has been started.

2.8.6 Keeping a manual ventilation device ready

If a fault is detected in the medical device, its life-support functions may no longer
be assured. The patient may be put at risk.
► Keep an independent ventilation device (e.g., a manual resuscitator) ready.
► Immediately start the ventilation of the patient using the independent ventilation
device. If required, perform ventilation with PEEP and/or with an increased
inspiratory O2 concentration.

2.8.7 Alarms
Alarm volume
If the alarm volume is too low, alarm signals may not be heard. The patient may be
put at risk.
► Set the alarm volume loud enough so that the alarm signals can be heard in the
environment where the device is located.
► The user must remain within hearing distance of the alarm signals.

2.8.8 Device
Ventilation slots
Obstructing or closing off the ventilation slots may cause the device to overheat. An
alarm is issued if the device overheats.
► Make sure air can easily enter the device at the ventilation slots.

Sources of heat
Direct sunlight or other external sources of heat may cause the device to overheat.
► Keep away from sources of heat such as direct sunlight, radiant warmer, or
spotlights.

Penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
As a result, the patient may be put at risk.
► Ensure that no liquid penetrates the device.
► Do not place any containers with liquids on or above the device.

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Safety-related information

Housing
Under the housing, there are live electrical components, which may cause an
electric shock.
► Do not open the housing of the device.

2.8.9 Display unit

If the touchscreen is cleaned or disinfected during therapy, the settings may
inadvertently be changed. The patient may be put at risk.
► Clean and disinfect the touchscreen only if no patient is connected.

2.8.10 Ventilation unit

Gas inlet for the inspiratory valve
If the gas inlet for the inspiratory valve is covered, it is not possible to perform
spontaneous breathing using the emergency breathing valve in the event of device
failure. The patient may suffocate.
► Do not obstruct the gas inlet for the inspiratory valve.

2.8.11 Accessories
Compatible accessories
The use of incompatible accessories may adversely affect the functional integrity of
the product. Personal injury and property damage may occur as a consequence.
► Use only compatible accessories. The accessories that are compatible with this
product are listed in the list of accessories supplied with the product.

Disposable products
Disposable products whose packaging has been opened may be contaminated with
infectious agents.
► Keep disposable products packaged until they are used. Do not use disposable
products whose packaging is damaged.
Disposable products are developed, inspected, and produced exclusively for single
use. Reuse, reprocessing or sterilization may lead to a failure of the accessories
and cause injuries to the patient.
► Do not reuse, reprocess, or sterilize disposable products.

Installing accessories
If accessories are not securely fastened, they may fall down. This may result in
personal injury and property damage.
► Install accessories to the main device in accordance with the instructions for use
of the main device.
► Make sure that there is a safe connection to the main device.

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 Safety-related information

2.8.12 Gases and solutions

Combustible or explosive gas mixtures
If oxygen concentrations over 25 Vol% or combustible or explosive gas mixtures
occur, there is an increased risk of explosion and fire that may result in personal
injury and property damage.
► Do not operate the device in areas where oxygen concentrations exceeding
25 Vol% or combustible or explosive gas mixtures may occur.
► Do not operate the device in areas where combustible solvents or explosive
anesthetic agents are used.

Ignition sources
Ignition source (e.g., open flames or sparks) may lead to fires in the presence of
oxygen. There may be a risk of personal injury.
► Keep the device away from ignition sources.

Increased oxygen concentration in the ambient air

Medical device malfunctions may increase the O2 concentration in the ambient air.
As a result, the medical device may ignite.
► Do not use the medical device in rooms that are enriched with oxygen.
► The medical device is suitable only for use in rooms with sufficient ventilation.

2.8.13 External flow source

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. The patient may be
put at risk.
► If necessary, use additional monitoring, e.g., external SpO2 monitoring.

Negative impacts on the measured values

An additional flow delivered by an external flow source may affect the measured
values for airway pressure and flow.
► Do not use additional flow.

2.8.14 Modifications to the product

Modifications to the product may lead to malfunctions and unforeseen risks. This
may result in injury to the patient or the user or in property damage.
► Do not modify this product.

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Safety-related information

2.8.15 Connected devices and device combinations

Any connected devices or device combinations that do not comply with the
requirements mentioned in these instructions for use may compromise the
functional integrity of the medical device. Personal injury and property damage may
occur as a consequence.
► Connections to electric devices not listed in this document may be made only if
approved by their manufacturer.
► Before this device is commissioned, the instructions for use of all connected
devices and device combinations must be heeded.

2.8.16 Data transfer

As a result of misinterpretation of the measured values or other parameters, an
incorrect diagnosis may be made and thus the patient may be put at risk.
► Do not use individual measured values and monitoring parameters as the sole
basis for therapeutic decisions.

2.8.17 Reprocessing
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
► Perform reprocessing according to the reprocessing instructions delivered with
the product.

2.8.18 Service
If service activities are not performed regularly, malfunctions may occur, which may
result in personal injury and property damage.
► Perform service activities in accordance with the chapter "Service".

2.8.19 Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. During installation and before initial
operation, follow the information in section: "EMC declaration" (page 266).

Electrostatic discharge
When components that bear the ESD warning symbol are handled, protective
measures against electrostatic discharge must be complied with. Otherwise,
malfunctions may occur that put the patient at risk.
To prevent malfunctions, observe the following measures and train the relevant
personnel:
► Follow the ESD protective measures, such as:
– Wear antistatic clothing and shoes.
– Use electrically insulating and antistatic gloves.
– When establishing connections, touch a potential equalization pin.
► Observe the requirements for the electromagnetic environment. Observe the
following section: "Electromagnetic environment" (page 266).

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 Safety-related information

Electromagnetic disturbances
Wireless communication devices (e.g., cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic
radiation. When such devices are operated too close to this device or its cables, the
functional integrity of this device may be compromised by electromagnetic
disturbances. As a result, the patient could be put at risk.
► Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless
communication devices, to ensure that the essential performance of this device
is fulfilled.
► Maintain an adequate distance between this device and other medical electrical
equipment.
In case of short electromagnetic disturbances as tested according to
IEC 60601-1-2, the following performance degradations may occur:
– Temporary black screens
– Disturbances of CO2 measurement
After elimination of the electromagnetic disturbances, the performance
degradations end at the latest after 8 seconds. In case of present alarms, the
secondary acoustic alarm system will be activated. The ventilation performance is
not affected. The ventilation unit operation display will indicate pressure, volume,
and FiO2.
The ventilator was tested according to the recommendations of
IEC TR 60601-4-2: Medical. During burst coupling of ±1 kV on mains, the following
performance degradations may occur:
– Temporary black screens
– Disturbances of CO2 measurement
After the burst coupling, the degradation of performance ends at the latest after
8 seconds without any user intervention. Changing to another power socket may
help. Burst coupling in the power network can be minimized or prevented by using a
corresponding mains filter in the power network.

2.8.20 Network security

Impermissible usage of data interfaces may result in new risks.
► Only create connections to data interfaces if permission for this has been
obtained from the organization responsible (party responsible for IT and party in
charge of the devices for the hospital).
► Observe the following information: "Connections to IT networks", page 268.

2.9 Further information

2.9.1 Training
Training for users is available via the Dräger organization responsible (see
www.draeger.com).

2.9.2 Mandatory reporting of adverse events

Serious adverse events with this product must be reported to Dräger and the
responsible authorities.

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Overview

3 Overview
3.1 Intensive care ventilator

41922
1 1

2 2

3 3

4 4

5 5

No. Designation
1 Display unit
2 Ventilation unit
3 GS500 gas supply unit
4 PS500 power supply unit
5 Trolley

For additional accessories, see the separate list of accessories.

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 Overview

3.2 Display unit

3.2.1 Front
1 2

38310
6 5 4 3

No. Designation Description

1 Alarm bar The alarm bar flashes briefly during For further infor-
the system startup and indicates that mation see: "Opti-
the alarm system is functioning prop- cal alarm
erly. signals",
page 157.
In the event of an alarm, the alarm bar
flashes in the color corresponding to
the alarm priority.
2 Screen The screen is a touchscreen. For further infor-
mation see:
"Screen",
page 41.
3 Pressing this key pauses all acoustic For further infor-
alarm signals for 2 minutes. mation see:
(Alarm silence "Alarm silence",
key) page 163.
4 Rotary knob The rotary knob is used to select and
confirm settings or functions.
5 LED for mains voltage For further infor-
mation see:
LED for the internal battery "Power supply
LED for the power supply unit PS500 indicators",
page 20.
6 On/off key For further infor-
mation see:
This key is used to switch the device
"Turning on the
on or off. The LED in the key lights up
device", page 89.
when the device is switched on.
For further infor-
mation see:
"Shutting down
the device",
page 150.

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Overview

3.2.1.1 Power supply indicators

LED lights up green LED lights up yel- LED does not light
low up
LED for Mains voltage is - The device is discon-
mains volt- available, and the nected from the
age main switch is acti- mains voltage.
vated
LED for the Battery charge is Battery charge is The internal battery is
internal bat- greater than approx. between approx. faulty or discharged,
tery 90 %. 10 % and 90 %. or the device is
switched off with the
main switch.
LED for the Battery charge is Battery charge is The power supply
power sup- greater than approx. between approx. unit is faulty or dis-
ply unit 90 %. 10 % and 90 %. charged, or the
PS500 device is switched off
with the main switch.

3.2.2 Rear

1 2

37930
3 3

43 5

No. Designation Description

1 Alarm bar The alarm bar flashes briefly during For further infor-
the system startup and indicates that mation see: "Opti-
the alarm system is functioning prop- cal alarm
erly. signals",
page 157.
In the event of an alarm, the alarm bar
flashes in the color corresponding to
the alarm priority.

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 Overview

No. Designation Description

2 COM Serial ports (RS-232) for exchanging For further infor-
data via communication protocols mation see: "Con-
(MEDIBUS) necting external
3 USB ports for exporting data, configu- devices to the
ration exchange, and installing soft- data interfaces",
ware options page 72.
4 LAN Port for service purposes
5 HDMI Port for external device (e.g., projec-
tor)

3.3 Ventilation unit

3.3.1 Front
Front, flap closed:

38312
6

4 1
2
3

No. Designation Description

1 Insp. Inspiratory valve with inspiratory port
(GAS OUTPUT)
2 Emergency air Gas inlet for the inspiratory valve, non-tapered connector,
intake do not obstruct (EMERGENCY AIR INTAKE)
3 Water trap Water trap container of the expiratory valve
4 Exp. Expiratory valve with expiratory port or neonatal expira-
tory valve with expiratory port
(GAS RETURN)
5 Flap Cover of the expiratory unit
For further information see: "Handling the flap", page 73.

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Overview

No. Designation Description

6 Operation display During ventilation, a bar display indicates the inspiratory
and expiratory phases. The measured values for the min-
ute volume MVe and inspiratory O2 concentration FiO2
are also displayed.
If the device is switched off and the power plug is con-
nected to the mains voltage, the charge status indicator of
the batteries and the symbol are displayed when the
batteries are charging.

Front, flap folded upwards:

38313
7
8
9
10
9

No. Designation Description

7 Exhaust Gas outlet, non-tapered connector
8 Expiratory flow Expiratory flow sensor (see "Fitting the expiratory flow
sensor sensor", page 76) or muffler (see "Assembling the neona-
tal expiratory valve", page 74)
Muffler
9 Connectors Ports for future extensions
10 Nebulizer port Gas outlet for the pneumatic medication nebulizer

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 Overview

3.3.2 Rear

38314
1
2
3
4
5
6

No. Designation Description

1 F3 Fuse for the internal battery
2 Neo Flow Port for the neonatal flow sensor
3 Ports for future extensions
4 CO2 Port for the CO2 sensor
5 Potential equalization pin
6 F1, F2 Fuse for the mains power supply
7 Port for the mains power supply

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Overview

3.3.3 Left side

38315
1
2
5

3 V2

4
5

No. Designation Description

1 Port for the system cable which leads to the display unit

2 USB port

3 Port for nurse call

4 V2 Port for future extensions

5 Main switch

6 Room air filter with cover

7 Strain relief for cable

3.3.4 Right side

38317
1
2

3
4

No. Designation Description

1 V9 Port for the data cable to the GS500 gas supply unit
2 Port for the gas connection to the GS500 gas supply unit

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 Overview

No. Designation Description

3 Air Port for compressed gas hose for Air
(FRESH GAS)
4 O2 Port for compressed gas hose for O2
(FRESH GAS)

3.4 Trolley

38318
1
2
3
4

5
6
7

No. Designation
1 Do not push
Mark on the device for areas whose risk of tipping over is increased as a
result of horizontal strain
2 Mount for the display unit
3 Handle
4 Trolley column
5 Hose holder
6 Guide
7 Holder with standard rail, can be swiveled
8 Universal holder with standard rail
9 Double castors with locking brake, 4 pieces

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Overview

3.5 GS500 gas supply unit

3.5.1 Rear

38319
1 1

3 2

1 1

No. Designation
1 Screws (to hold the side panels in place)
2 Rating plate
3 Gas connection

3.6 Range of functions

General information
This section describes the entire functionality of the device. Some functions are
only optional and may deviate from the individual device configuration. Options are
shown in the separate list of accessories.

3.6.1 Therapy types

– Invasive ventilation (Tube)
– Non-invasive ventilation (NIV)
– O2 therapy

3.6.2 Ventilation functions

Detailed descriptions are available in the following sections:
– Ventilation functions (see "Principles of operation", page 272)
– Abbreviations (see "Abbreviations", page 29)

Ventilation modes
Volume-controlled ventilation:
– VC-SIMV
– VC-AC
– VC-CMV
– VC-MMV

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 Overview

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

Additional settings for ventilation

– Apnea ventilation
– Trigger
– Sigh
– AutoFlow
– Volume guarantee
– ATC
– AutoRelease
– Variable PS
– SmartCare/PS

Other ventilation functions

– "Insp term" during pressure support
– Anti-air shower

Maneuvers
– Manual insp./inspiration hold
– Expiration hold
– O2/suctioning
– Manual disconnection
– Nebulization
– Measurement maneuver Low-flow PV loop
– Diagnostics – measurement maneuver
– Measurement of intrinsic PEEP (PEEPi)
– Measurement of occlusion pressure (P0.1)
– Measurement of maximum inspiratory effort of the patient (NIF)

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3.6.3 Monitoring functions of ventilation monitoring

Patient monitoring is supported by the following alarm limit settings:
– Maximum airway pressure (Paw)
– Expiratory minute volume (MVe)
– Inspiratory tidal volume (VTi or VT)
– Apnea alarm time (Tapn)
– Spontaneous respiratory rate (RRspon)
– End-tidal CO2 concentration (etCO2)
The inspiratory O2 concentration is monitored by automatically set limits.
During non-invasive ventilation and O2 therapy, certain monitoring functions are
deactivated or can be deactivated.

3.6.4 Screen displays

– Waveforms
– Graphical trends
– Loops
– Alarm logbook
– Logbook
– Numeric parameters
– Lists for measured values and set values
– User-specific lists for measured values and set values
– Smart Pulmonary View

3.6.5 Power supply

The device is designed for connection to the hospital's mains power supply of 100
to 240 V at 50/60 Hz.
If the mains voltage fails, operation can be maintained via the internal battery or the
PS500 power supply unit.

3.6.6 Gas supply

The device features country-specific connectors for the gas supply with oxygen and
medical compressed air.
Additionally, the device can be equipped with the GS500 gas supply unit. GS500
supplies the device with compressed air.

3.6.7 O2 therapy
The device provides high-flow oxygen therapy.

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 Overview

3.6.8 Data transfer

COM port
The following communication protocols are available for exchanging data between
the device and external medical or non-medical devices:
– MEDIBUS.X
– MEDIBUS
– MED.X.Comp.

USB port
After suitable USB mass storage devices are connected, the following actions (and
others) are possible:
– Export the data.
– Save the screen content as a screenshot.
– Save and load the device configuration.
– Install the software options.
The nebulizer Aeroneb Pro can be connected to the USB port.

LAN port
Use of the port is exclusively permitted for service purposes.

HDMI port
For demonstrative purposes, an external device (e.g., projector) can be connected.

3.6.9 Medication nebulization

For medication nebulization a pneumatic medication nebulizer can be connected.

3.6.10 Attaching accessories

Various holders can be used to attach accessories. The holders are attached to the
device or the trolley.

3.7 Abbreviations
Abbreviation Explanation
% leak Leakage proportion the of inspiratory minute volume in percent
% MVspon Spontaneous breathing portion of minute volume in percent
Adult Adult patient category
Ah Ampere hours (output specification for batteries)
Air Label on the device, port for compressed gas hose for Air
(FRESH GAS)
Alarm reset Dismissing an alarm message that is no longer active
Apnea vent. Apnea ventilation
APRV Airway Pressure Release Ventilation
ATC Automatic tube compensation

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Overview

Abbreviation Explanation
AutoFlow Special function for automatic optimization of inspiratory flow
BF Body Floating
BTPS Body temperature, pressure, saturated
37 °C (98.6 °F) body core temperature, ambient pressure,
100 % relative humidity
C Compliance
C20/Cdyn Ratio of the dynamic compliance of the last 20 % of inspiration
to total dynamic compliance
C20/Cstat Ratio of the static compliance of the last 20 % of inspiration to
total static compliance. Is determined using the low-flow
maneuver.
Cdyn Dynamic compliance
CISPR Comité International Spécial des Perturbations Radioélec-
triques
International special committee on radio interference
CO2 slope Increase of measured CO2 value in phase III of the CO2 wave-
form
COM Serial port
Compens Degree of tube compensation
COPD Chronic Obstructive Pulmonary Disease
Cstat Static compliance
Cycles sigh Number of respiratory cycles per sigh phase (set value)
DHCP Communication protocol
ΔintPEEP Additional intermittent PEEP for sighs (set value)
ΔPsupp Relative pressure support above PEEP (set value)
E Elastance
EIP End-inspiratory pressure
EMC Electromagnetic compatibility
Emergency air Safety air inlet, inspiratory relief valve (EMERGENCY AIR
intake INTAKE)
Endotrach. Endotracheal tube
ESD Electrostatic discharge
etCO2 End-tidal CO2 concentration
Exhaust Gas outlet
Exp term Expiration termination criterion in percent of the peak expiratory
flow
Exp. Label on the device, expiratory port (GAS RETURN)
Exp. Expiration
FiO2 Inspiratory O2 concentration (set value)
Flow Flow (set value)

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Abbreviation Explanation
Flow assist Flow-based assistance in ventilation mode SPN-PPS (set
value)
Flow max Peak inspiratory flow during non-invasive ventilation (patient
category Neonate)
Flowepeak Peak expiratory flow
Flowipeak Peak inspiratory flow
GS500 Gas supply unit
HDMI High Definition Multimedia Interface
HF High-frequency
I:E Ratio of inspiratory time to expiratory time (set value)
I:E spon I:E during spontaneous breathing
IBW Ideal body weight (kg)
IEC/CEI Acoustic alarm signal according to the standard IEC 60601-1-8
incl. PEEP Measured PEEP after complete expiration at the set PEEP
level
Insp term Inspiration termination criterion in percent of the peak inspira-
tory flow
Insp. Label on the device, inspiratory port (GAS OUTPUT)
Insp. Inspiration
Insp. flow Inspiratory flow
Interval sigh Interval between two sigh phases (set value)
IP21 Degree of protection against ingress of liquids and particles
LAN Local Area Network
LIP Lower inflection point
MED.X.Comp. Communication protocol for medical devices with a data defini-
tion that is standardized across all devices
MEDIBUS Communication protocol for medical devices
MEDIBUS.X Communication protocol for medical devices with uniform data
definition for all devices
Minute volume
Upper alarm limit for minute volume
high
Minute volume
Lower alarm limit for minute volume
low
MV Minute volume, leakage-corrected
MV delay Delay time for the Minute volume high and Minute volume
low alarms
MVapn Minute volume during apnea ventilation
MVe Expiratory minute volume, overall, not leakage-corrected
MVemand Mandatory expiratory minute volume
MVespon Spontaneous expiratory minute volume
MVi Inspiratory minute volume, overall, not leakage-corrected

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Abbreviation Explanation
MVleak Leakage minute volume
Neonate Neonates patient category
NIF Negative Inspiratory Force
NiMH Nickel-metal hydride, battery technology
NIV Non-invasive ventilation
NTPD Normal temperature, pressure, dry
20 °C (68 °F), 1013 hPa, dry
O2 Label on the device, port for compressed gas hose for O2
(FRESH GAS)
O2/suctioning Suction maneuver
P0.1 Occlusion pressure in P0.1 maneuver
Palv Alveolar pressure
Paw Airway pressure
Paw high Upper alarm limit for airway pressure
PC-AC PC: Pressure Control, AC: Assist Control
Assisted-controlled, pressure-controlled ventilation with back-
up respiratory rate
PC-APRV PC: Pressure Control, APRV: Airway Pressure Release Ventila-
tion
Spontaneous breathing under continuous positive airway pres-
sure with brief pressure releases
PC-BIPAP PC: Pressure Control, BIPAP: Biphasic Positive Airway Pres-
sure
Spontaneous breathing under continuous positive airway pres-
sure with 2 different pressure levels
PC-CMV PC: Pressure Control, CMV: Controlled Mandatory Ventilation
Continuous pressure-controlled ventilation
PC-PSV PC: Pressure Control, PSV: Pressure Support Ventilation
Spontaneous breathing at continuous positive pressure level
with pressure support and backup frequency
PC-SIMV PC: Pressure Control, SIMV: Synchronized Intermittent Manda-
tory Ventilation
Intermittent, triggered, pressure-controlled ventilation
Pediatric patient Pediatric patient category
PEEP Positive end-expiratory pressure
PEEPi Intrinsic PEEP
Phigh Upper pressure level in ventilation mode PC-APRV (set value)
Pinsp Inspiratory pressure (set value)
PIP Peak Inspiratory Pressure
Plimit Pressure limitation for low-flow maneuver (set value)
Plow Lower pressure level in ventilation mode PC-APRV (set value)

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Abbreviation Explanation
Pmaninsp Inspiratory pressure for manual inspiration during non-invasive
ventilation (patient category Neonate, ventilation mode SPN-
CPAP)
Pmax Maximum allowed airway pressure (set value)
Pmax/Paw high Linking the maximum airway pressure to the alarm limit Paw
autoset high
PMC Point of maximum curvature
Pmean Mean airway pressure
Pmin Minimum airway pressure
Pplat Plateau pressure
Press var Pressure support variability for the function Variable PS (set
value)
PS Pressure support
PS500 Power supply unit
Pstart Initial pressure for low-flow maneuver (set value)
Psupp Absolute pressure support
Ptrach Tracheal pressure
R Resistance
Respiratory rate
Upper alarm limit for respiratory rate
high
Rpat Airway resistance of the patient
RR Respiratory rate (set value)
RRapn Respiratory rate during apnea ventilation (set value)
RRmand Mandatory respiratory rate
RRspon Spontaneous respiratory rate
RRtrig Respiratory rate of triggered mandatory breaths
RSBI Rapid shallow breathing index
Quotient of spontaneous respiratory rate and tidal volume
r² Correlation coefficient for the calculation method "Least Mean
Square" for resistance R, compliance, C and time constant TC
SIM Subscriber Identity Module
Participant identification
Slope Pressure rise time (set value)
Smart Pulmo-
Graphic display of lung characteristics
nary View
SPN-CPAP SPN: Spontaneous, CPAP: Continuous Positive Airway Pres-
sure
Spontaneous breathing with continuous positive pressure level
SPN-CPAP/PS SPN: Spontaneous, CPAP: Continuous Positive Airway Pres-
sure, PS: Pressure Support
Spontaneous breathing with continuous positive pressure level
with or without pressure support

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Abbreviation Explanation
SPN-CPAP/VS SPN: Spontaneous, CPAP: Continuous Positive Airway Pres-
sure, VS: Volume Support
Spontaneous breathing with continuous positive pressure level
with or without volume support
SPN-PPS SPN: Spontaneous, PPS: Proportional Pressure Support
Spontaneous breathing with flow- and volume-proportional
pressure support
SpO2 Pulse oximetry O2 saturation
STPD Standard temperature, pressure, dry
0 °C (32 °F), 1013 hPa, dry
Tapn Apnea alarm time (set value)
TC Time constant tau
TCe Time constant calculated from expiratory tidal volume and peak
expiratory flow
Tdiscon Disconnection alarm time (set value)
Te Expiratory time (set value)
Thigh Time of the upper pressure level in ventilation mode PC-APRV
(set value)
Ti Inspiratory time (set value)
Tidal volume
Upper alarm limit for the inspiratory tidal volume
high
Tidal volume low Lower alarm limit for the inspiratory tidal volume
Timax Maximum inspiratory time for flow during pressure or volume
support (set value)
Tispon Inspiratory time during spontaneous breathing
Tlimit Calculated maximum time for low-flow maneuver
Tlow Time of the lower pressure level in ventilation mode PC-APRV
Tlow max Maximum expiratory time during ventilation mode PC-APRV
(set value)
Tmaninsp Duration of the breath for manual inspiration during non-inva-
sive ventilation (patient category Neonate, ventilation mode
SPN-CPAP)
Tplat Time of inspiratory plateau
Trach. Tracheostomy tube
Trigger Trigger threshold, sensitivity (set value)
Tube Ø Inner diameter of the tube
UIP Upper inflection point
UN Nominal voltage
USB Universal Serial Bus
Serial bus system
Variable PS Variable pressure support in ventilation mode SPN-CPAP/PS

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Abbreviation Explanation
VC-AC VC: Volume Control, AC: Assist Control
Assisted-controlled, volume-controlled ventilation with fixed
inspiratory flow and backup respiratory rate
VC-CMV VC: Volume Control, CMV: Controlled Mandatory Ventilation
Continuous volume-controlled ventilation
VC-MMV VC: Volume Control, MMV: Mandatory Minute Ventilation
Volume-controlled ventilation to ensure a minimum minute vol-
ume
VC-SIMV VC: Volume Control, SIMV: Synchronized Intermittent Manda-
tory Ventilation
Intermittent, triggered, volume-controlled ventilation
Vds Serial dead space up to the CO2 cuvette
Vds/VTe Ratio of serial dead space to expiratory tidal volume
VG Volume guarantee
Vlimit Volume limit for low-flow maneuver (set value)
Vol assist Volume support in ventilation mode SPN-PPS (set value)
VRLA Valve-regulated lead-acid, battery technology
VS Volume support
VT Tidal volume, leakage-corrected
VT/IBW Tidal volume relative to ideal body weight
VTapn Tidal volume for apnea ventilation (set value)
VTCO2 Amount of CO2 expired per spontaneous breath
VTe Expiratory tidal volume, not leakage-corrected
VTemand Expiratory tidal volume during a mandatory breath
VTespon Expiratory tidal volume during a spontaneous breath
VTi Inspiratory tidal volume, not leakage-corrected
VTimand Inspiratory tidal volume during a mandatory breath
VTispon Inspiratory tidal volume during a spontaneous breath
VTmand Tidal volume during a mandatory breath
Vtrap Volume trapped in the lungs due to intrinsic PEEP
VTspon Tidal volume during a spontaneous breath
V̇ CO2 Amount of CO2 expired per minute

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3.8 Symbols
Additional information about the symbols is available on the following web page:
www.draeger.com/md-symbols

3.8.1 Symbols on the device and trolley

Symbol Explanation
Observe the instructions for use
Observe the instructions for use
Attention!
Observe accompanying documents
General warning

On/off key
Mains voltage
Internal battery
Power supply unit PS500
Alarm silence key

Exhaust Gas outlet (EXHAUST)

Port for medication nebulizer
Expiratory valve locked

Expiratory valve unlocked

Main switch is turned on

Main switch is turned off

Port for the neonatal flow sensor
Applied part type BF (body floating)

Potential equalization connector

Connection to protective grounding

Fuse

Port for nurse call

USB port

Port for system cable

YYYY-MM-DD
Date of manufacture
Manufacturer

36 Instructions for use | Evita V800 / V600 SW 1.n