Dräger Perseus A500 User manual

Instructions for use
Perseus A500
WARNING
To properly use this medical
device, read and comply with
these instructions for use.
Anesthesia workstation
Software 2.0n
Perseus A500

2 Instructions for use Perseus A500 SW 2.0n
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Instructions for use Perseus A500 SW 2.0n 3
Contents
Perseus A500
Contents
Information about this document................. 5
Applicability of these instructions for use......... 5
Typographical conventions.............................. 5
Use of terms .................................................... 5
Illustrations ...................................................... 5
Further documents .......................................... 6
Trademarks ..................................................... 6
Safety information definitions .......................... 6
User group requirements................................. 7
For your safety and that of your patients.... 8
General safety information .............................. 9
Product-specific safety information.................. 12
Application ..................................................... 14
Intended use.................................................... 15
Indications/Contraindications........................... 15
Further information on application ................... 16
Overview......................................................... 17
Hardware......................................................... 18
Functional scope ............................................. 33
Gas flow plan................................................... 36
Operating concept ......................................... 39
Screen ............................................................. 40
Color concept .................................................. 42
Selecting and setting ....................................... 43
Remote control for the ceiling-mounted version
(combination with Dräger ceiling supply units) 44
Safety sensor................................................... 45
Assembly and preparation............................ 46
Perseus as a ceiling-mounted version............. 47
Mounting of accessories.................................. 49
Before first operation ....................................... 52
Intrahospital transport...................................... 56
Establishing the gas supply ............................. 57
Ensuring the gas scavenging .......................... 62
Preparation for a day of operations / after
reprocessing .................................................... 63
Selecting and connecting patient-specific
accessories...................................................... 67
Connecting or exchanging consumables......... 76
Getting started ............................................... 79
Turning on Perseus ......................................... 80
Checking the device configuration .................. 81
Checking the operational readiness ................ 81
Emergency start-up ......................................... 82
Operation ........................................................ 83
Safety information ........................................... 85
Starting the therapy ......................................... 87
Adjusting the therapy....................................... 90
Special forms of therapy.................................. 93
Maneuvers (optional)....................................... 95
Using fields with special functions ................... 100
Organizing the screen display ......................... 105
Displaying additional data ............................... 108
Setting the sound volume................................ 110
Adjusting the alarms........................................ 110
Changing the patient data ............................... 113
Exporting data ................................................. 113
Other settings .................................................. 114
Ending the therapy .......................................... 116
Change of patient ............................................ 118
Tests ............................................................... 120
Information on the availability of individual
device functions............................................... 121
Testing the device ........................................... 121
Performing the tests ........................................ 123
Completing the checklist ................................. 126
Ending operation ........................................... 135
Turning off the device...................................... 136
Alarms............................................................. 138
Displaying alarms ............................................ 139
Response to alarms ........................................ 140
Adopting alarm settings when changing the
ventilation mode .............................................. 143
Alarm delay and alarm escalation ................... 144
Activation of alarms after breath detection ...... 147
Intelligent alarm behavior ................................ 147

Contents
4 Instructions for use Perseus A500 SW 2.0n
Configuration ................................................. 148
Device settings ................................................ 149
Setting the date and time ................................ 149
Defining the start settings ................................ 150
Transferring device configurations .................. 171
Activating software options.............................. 172
Overview of configurable screen contents ...... 173
Troubleshooting ............................................ 180
Leakage........................................................... 181
Power supply failure ........................................ 182
Emergency O2delivery (electronically
controlled gas mixer) ....................................... 183
Failure of the gas supply ................................. 184
Failure of fresh-gas delivery (electronically
controlled gas mixture) .................................... 186
Ventilator failure .............................................. 186
Gas measurement failure ................................ 187
Flow measurement failure ............................... 187
Screen fault/user interface failure.................... 188
Complete failure .............................................. 188
Problems with the anesthetic gas receiving
system (AGS) .................................................. 189
Problems with cylinder pressure reducers ...... 190
Problems with the Vapor View option.............. 190
Support request............................................... 190
Alarm – Cause – Remedy ............................... 191
Service............................................................ 214
Safety information ........................................... 215
Transport for maintenance purposes .............. 216
Definition of service terminology ..................... 216
Inspection ........................................................ 217
Maintenance.................................................... 219
Repair.............................................................. 220
Disposal.......................................................... 221
Safety information ........................................... 222
Disposing of the device ................................... 222
Disposing of accessories................................. 222
Technical data................................................ 223
General information......................................... 224
Ambient conditions .......................................... 224
Fresh-gas delivery........................................... 225
Fresh-gas delivery (electronically controlled
gas mixer)........................................................ 225
Fresh-gas delivery (mechanically controlled
gas mixer)........................................................ 226
Ventilator ......................................................... 226
Breathing system............................................. 229
External fresh-gas outlet ................................. 231
Anesthetic gas receiving system ..................... 231
Measuring systems and displays .................... 231
Display of calculated values ............................ 237
Operating characteristics................................. 238
Device outputs................................................. 244
Relevant standards ......................................... 247
Diagrams ......................................................... 249
Device combinations ....................................... 250
EMC declaration.............................................. 251
Emission of high-frequency energy ................. 252
Connections to IT networks............................. 253
Open-source software ..................................... 256
Principles of operation.................................. 257
Description of the ventilation modes ............... 258
Minimum O2delivery ....................................... 268
Influence of patient category, weight, and age
on device behavior .......................................... 269
Infinity ID accessory support ........................... 269
Schematic diagram of alarm tones.................. 271
Combination lock on the drawer (optional)...... 272
Annex.............................................................. 274
Abbreviations................................................... 275
Symbols........................................................... 277
Product labels.................................................. 280
Overview of the menu structure ...................... 282
Password........................................................ 285
Configuration password for Perseus
A500 Software 2.0n......................................... 285
Index ............................................................... 287

Instructions for use Perseus A500 SW 2.0n 5
Information about this document
Information about this document
Applicability of these instructions for use
This document applies to products with software
version 2.03 or higher.
Typographical conventions
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 product "Perseus A500" is also referred to as
"Perseus".
Illustrations
Illustrations of products and screen content in this
document may differ from the actual products
depending on configuration and design.
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet points indicate individual actions or dif-
ferent options for action.
– Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
related illustration.
ALetters in illustrations denote elements
referred to in the text.
> The greater-than symbol indicates the naviga-
tion path in a dialog window.
Bold, italicized text indicates labels on the
device and texts that are displayed on the
screen.

Information about this document
6 Instructions for use Perseus A500 SW 2.0n
Further documents
The reprocessing of this product is described in
the separate reprocessing instructions supplied
with the product.
Trademarks
Trademarks owned by Dräger The following web page provides a list of the
countries in which the trademarks are registered:
www.draeger.com/trademarks
Trademarks owned by third-party
manufacturers
Safety information definitions
Trademark
Perseus®
Infinity®
D-Vapor®
Drägersorb®
MEDIBUS®
ServiceConnect®
WaterLock®
Trademark Trademark owner
Selectatec®Datex-Ohmeda
Trademark used
under license
Trademark owner
BIPAP Respironics
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 Perseus A500 SW 2.0n 7
Information about this document
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.
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.
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 anesthesia. Users have knowledge of
device monitoring and perioperative 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.
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.

For your safety and that of your patients
8 Instructions for use Perseus A500 SW 2.0n
For your safety and that of your patients
General safety information ........................... 9
Strictly follow these instructions for use .......... 9
Service ............................................................ 9
Accessories ..................................................... 9
Patient safety................................................... 10
Patient monitoring ........................................... 10
Electromagnetic compatibility (EMC) .............. 11
Training ........................................................... 11
Keeping the instructions for use ...................... 11
Product-specific safety information ............ 12
Essential performance..................................... 13
Handling Infinity ID components...................... 13

Instructions for use Perseus A500 SW 2.0n 9
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
its subsystems or particular features appear in the
respective sections of these instructions for use or
in the instructions for use of any other product
being used with this device.
Strictly follow these instructions for use
Service
Accessories
WARNING
Risk of incorrect operation and incorrect use
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" (see
page 15) 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.
WARNING
Risk if service is not performed regularly
If service is not performed regularly,
malfunctions may occur, which can result in
personal injury and property damage.
Perform the service in accordance with the
chapter "Service".
WARNING
Risk due to incompatible 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.
WARNING
Risk due to faulty accessories
The use of faulty accessories may
compromise the functional integrity of the
product. Personal injury and property
damage may result.
Use only accessories that are in good
working order.
WARNING
Risk due to misoperation, incorrect use, or
incorrect reprocessing
Strictly observe the instructions for use of all
accessory parts, e.g.:
– Water traps
– Flow sensors
– CLIC adapter
– CLIC absorber
–Sodalime
– Breathing hoses
– Masks
– Filter
– Bronchial suction
– Vaporizer
– Manual resuscitator
– AGSS terminal unit

For your safety and that of your patients
10 Instructions for use Perseus A500 SW 2.0n
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.
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
medical device
– Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.
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.

Instructions for use Perseus A500 SW 2.0n 11
For your safety and that of your patients
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 251).
This device can be affected by other electrical
devices.
Training
User training is offered by the responsible Dräger
organization, see www.draeger.com.
Keeping the instructions for use
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against
electrostatic discharge are employed in the
following situations:
– When touching the pins of connectors
that carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the
following measures and train the relevant
personnel:
– Observe the ESD protective measures.
Such measures may include wearing
antistatic clothing and shoes, touching a
potential equalization pin before and while
making the connection, or using
electrically insulating and antistatic
gloves.
– Observe the requirements for the
electromagnetic environment. Observe
the following section: "Electromagnetic
environment" (page 251).
WARNING
Risk due to electromagnetic disturbance
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.
WARNING
Risk of operating errors
The instructions for use must be kept in an
accessible location for users.

For your safety and that of your patients
12 Instructions for use Perseus A500 SW 2.0n
Product-specific safety information
WARNING
Risk due to device failure
Device failure can compromise the correct
therapy functionality of the device.
To ensure immediate remedial action in case
of device failure, the device may only be
operated under permanent supervision of
users. Always have a manual resuscitator
ready.
WARNING
Dräger recommends that the user remains in
the vicinity of the anesthesia machine, i.e.
within a distance of up to 4 meters (12 feet).
This facilitates fast recognition and response
in the event of an alarm.
WARNING
Risk due to modifications
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.
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.
– Do not use cyclopropane or ether.
WARNING
Risk due to 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 particle-free.
CAUTION
Risk of crushing
Movable device parts or attached components
may cause crushing due to clamping. Pay special
attention to edges, movable parts, and corners
when working with the following components:
– Column cover
– Breathing system cover
–Drawers
– Extensible writing tray
– Swivel arms for mounted devices
– Accessories such as gas cylinders,
vaporizers, CLIC absorber, and CLIC adapter
WARNING
Risk due to electromagnetic fields
Although the medical device does not exceed
the applicable limiting values for
electromagnetic fields, such radiation can
interfere with the functioning of pacemakers.
All wearers of pacemakers should maintain a
distance of at least 25 cm (10 in) between
pacemaker and medical device.

Instructions for use Perseus A500 SW 2.0n 13
For your safety and that of your patients
Essential performance
General
– Supply of the anesthesia workstation with O2:
If the O2supply (central gas supply or gas
cylinder) fails, an alarm is issued.
– Supply of the patient with adequately
oxygenated breathing gas:
If the breathing gas contains insufficient levels
of O2, an alarm is issued.
– Patients are not supplied with excessively high
anesthetic gas concentrations:
If excessively high anesthetic gas
concentrations are delivered, an alarm is
issued.
– Monitoring of the airway pressure:
Alarms are issued depending on the set alarm
limits.
Gas measurement
– Breathing gas monitoring:
Measurement of the gas composition with ISO
accuracy.
– Monitoring of the breathing gas concentrations:
If a set alarm limit is exceeded or the gas
measurement fails, alarms will be issued.
Handling Infinity ID components
Ownership or purchase of this medical device with
RFID technology only includes 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.

Application
14 Instructions for use Perseus A500 SW 2.0n
Application
Intended use .................................................. 15
Indications/Contraindications ...................... 15
Indications ....................................................... 15
Contraindications............................................. 15
Further information on application .............. 16
Environments of use........................................ 16

Instructions for use Perseus A500 SW 2.0n 15
Application
Intended use
The Perseus anesthesia workstation is intended
for use in anesthetizing adults, children, and
neonates and can be used for automatic and
manual ventilation, pressure-supported
spontaneous breathing, and spontaneous
breathing.
Perseus is equipped with airway monitoring, gas
measurement and device monitoring, O2
insufflation, and an anesthetic gas receiving
system.
Anesthesia is achieved through a mixture of pure
oxygen and Air (medical compressed air) or pure
oxygen and nitrous oxide, with the addition of
volatile anesthetic agents.
Ventilation is accomplished on the patient through
a laryngeal mask airway, a full-face mask, or an
endotracheal tube.
The integrated breathing system can be used with
partial rebreathing (low-flow or minimum-flow).
A non-rebreathing system such as the Kuhn or
Medec Water System may be used at the external
fresh-gas outlet (optional).
Indications/Contraindications
Indications
Perseus is specified for inhalational anesthesia
and/or patient ventilation in accordance with the
intended use during surgical or diagnostic
interventions.
Contraindications
–Perseus applies medications such as oxygen,
nitrous oxide, or volatile anesthetic agents,
among others. For contraindications to the
applied medications, strictly follow the
instructions for use of the medication.
– Do not use soda lime based on potassium
hydroxide. Otherwise, there is a risk of CO
formation.
– Only use pelletized soda lime. Otherwise, there
is a risk of faulty measurement or faulty
delivery as well as progressive damage to the
breathing system due to dust.
– For patients suspected of malignant
hyperthermia: Do not use any volatile
anesthetic agent or Perseus with residual
concentrations of these gases above 5 ppm.
– Do not perform low-flow anesthesia on patients
with ketoacidosis or patients under the
influence of alcohol. Otherwise, there is a risk
of acetone accumulation in the patient.
The user is responsible for setting the gas delivery
and ventilation according to the individual patient
status. Patient status must be continually
monitored for any potential changes.

Application
16 Instructions for use Perseus A500 SW 2.0n
Further information on application
Environments of use
Perseus is designed for use in rooms in which
therapeutic or diagnostic interventions can be
performed under permanent supervision of users.
Also, do not use Perseus in the following
environments:
– Outside buildings
– On intensive care units
– During patient transport
– In vehicles, airplanes, or helicopters
WARNING
Risk of explosion and fire
This medical device is neither approved nor
certified for use in areas where oxygen
concentrations greater than 25 Vol%,
combustible or explosive gas mixtures are
likely to occur.
WARNING
Risk of device malfunctions and/or patient
injury and user injury
Magnetic fields can negatively influence the
correct functioning of the medical device and
therefore endanger the patient or user.
Do not use the medical device in rooms
where devices for magnetic field applications
are used (e.g., magnetic resonance imaging).

Instructions for use Perseus A500 SW 2.0n 17
Overview
Overview
Hardware ........................................................ 18
Front (trolley version)....................................... 18
Front (ceiling-mounted version)....................... 19
Screen ............................................................. 19
Plug-in connection with Vapor View option for
up to 3 vaporizers ............................................ 20
Breathing system............................................. 21
Side view from left ........................................... 22
Device column................................................. 23
Rear (trolley version) ....................................... 24
Rear (ceiling-mounted version) ....................... 26
Interfaces......................................................... 27
Gas inlets......................................................... 28
Hanger yokes (optional) for gas cylinders with
pin-index connections...................................... 29
Auxiliary power sockets (trolley version) ......... 30
Gas mixing unit (electronically controlled) ....... 31
Gas mixing unit (mechanically controlled) ....... 32
Functional scope ........................................... 33
Device versions, options, and accessories...... 33
Gas delivery..................................................... 33
Ventilation modes ............................................ 33
Additional operation modes ............................. 33
Monitoring........................................................ 33
Display on the screen ...................................... 34
Protocoling....................................................... 34
Gas supply....................................................... 34
Gas scavenging............................................... 34
Data exchange, interfaces............................... 35
Gas flow plan ................................................. 36
Breathing system............................................. 36
Gas supply (electronically controlled gas
mixer)............................................................... 37
Gas supply (mechanically controlled gas
mixer)............................................................... 38

Overview
18 Instructions for use Perseus A500 SW 2.0n
Hardware
Front (trolley version)
AScreen with integrated workplace illumination
BGas mixing unit (electronically controlled gas
mixer shown here)
CWork surface
DDrawer or pull-out writing tray with lockable
compartment (optional)
ECentral brake
FCastors with central brake
GFootrest
HTrolley
IAnesthetic gas receiving system with flow
indicator
JCO2absorber
KAPL valve
LExternal fresh-gas outlet (optional)
MPlug-in connector with Vapor View option for up
to 3 vaporizers (the version for 2 vaporizers is
shown here)
10335
A
B
C
D
E
F
G
I
J
K
L
M
H

Instructions for use Perseus A500 SW 2.0n 19
Overview
Front (ceiling-mounted version)
Differences from the trolley version:
ARemote control for controlling and positioning
the ceiling supply unit (functions dependent on
the type of the ceiling supply unit)
BLockable drawer (optional)
CSafety sensor
DDevice column without trolley
Although the remote control and the safety sensor
are mounted on Perseus, from an electrotechnical
point of view they are part of the connected ceiling
supply unit. The safety sensor functions with any
ceiling supply unit.
Screen
ATouchscreen to call up functions or dialog
windows
BAudio paused key to suppress the alarm
tones of all active alarms for 2 minutes
CRotary knob with background illumination to
select and confirm settings
DKey for switching the workplace
illumination on and off and dimming the
illumination intensity in 3 steps (dark, medium,
and bright)
EKey for turning the device on or off
18909
A
B
C
D
10340
A
C
DE B

Overview
20 Instructions for use Perseus A500 SW 2.0n
Plug-in connection with Vapor View option for up to 3 vaporizers
The version for 2 vaporizers is shown here:
ASensor unit
BIllumination unit
10397
A
B