perseus_a500__instructions_for_use_sw_1-0n.pdf
Page 1
Instructions for use
Perseus A500
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Anesthesia workstation
Software 1.0n
Page 2
Typographical conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
z Bullet points indicate individual actions or
different options for action.
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for
example, PEEP, etCO2, or Start sett. fresh-gas.
(A) Letters in parentheses refer to elements in the
related illustration.
The "greater than" symbol > indicates the
navigation path in a dialog window, for example,
System setup > Alarms > Alarm limits. In this
example, System setup represents the dialog
window title, Alarms represents a horizontally
aligned tab, and Alarm limits a vertically aligned
tab.
A Letters in illustrations denote elements referred
to in the text.
Product names in use
–
Dashes indicate the listing of data, options, or
objects.
In these instructions for use, instead of "Perseus
A500", the labeling Perseus is used.
Screen images
Schematic renderings of screen images are used,
which may differ in appearance or in configuration
from the actual screen images.
Trademarks
–
Perseus®
–
Infinity®
–
DrägerService®
–
Dräger-Vapor®
–
D-Vapor®
–
Drägersorb®
–
MEDIBUS.X®
–
WaterLock®
–
BIPAP*
*
Trademark used under license
are trademarks owned by Dräger.
–
Selectatec®
is a trademark owned by Datex-Ohmeda.
2
Instructions for use Perseus A500 SW 1.0n
Page 3
Safety information definitions
WARNING
CAUTION
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
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.
Definition of target groups
For this product, users, service personnel, and
experts are defined as target groups.
Service personnel
These target groups must have received
instruction in the use of the product and must have
the neces-sary training and knowledge to use,
install, repro-cess, maintain, or repair the product.
The target groups must understand the language
of the present document.
Service personnel are persons who are
responsible for the maintenance of the product.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined
target groups.
Users
Users are persons who use the product in
accordance with its intended use.
Instructions for use Perseus A500 SW 1.0n
Service personnel must be trained in the
maintenance of medical devices and install,
reprocess, and maintain the product.
Experts
Experts are persons who perform repair or
complex maintenance work on the product.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
3
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Abbreviations and symbols
Explanations can be found in the sections
''Abbreviations'' and ''Symbols'' in chapter ''Annex''.
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Instructions for use Perseus A500 SW 1.0n
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Contents
Contents
For your safety and that of your patients....
7
General safety information ..............................
8
Product-specific safety information.................. 11
Application ..................................................... 13
Intended use.................................................... 14
Indications/Contraindications........................... 14
Further information on application ................... 15
Overview......................................................... 16
Hardware ......................................................... 17
Functional scope ............................................. 27
Operating concept......................................... 30
Screen ............................................................. 31
Color concept .................................................. 33
Selecting and setting ....................................... 34
Assembly and preparation ........................... 36
Mounting the accessories................................
Before first operation .......................................
Transport within the hospital............................
Establishing the gas supply .............................
Establishing the gas scavenging .....................
Preparation for an operation day / after
cleaning and sterilization .................................
Selecting and connecting patient-specific
accessories......................................................
Connecting or exchanging consumables.........
37
38
41
42
45
46
50
56
Changing the patient data ............................... 84
Data export...................................................... 84
Making additional settings ............................... 85
Ending the therapy .......................................... 86
Patient change ................................................ 87
Switching off the device................................... 89
System test ....................................................
91
Viewing the availability of individual device
functions .......................................................... 92
Testing the system .......................................... 92
Performing tests .............................................. 94
Processing the checklist.................................. 95
Alarms ............................................................ 100
Alarm signals...................................................
Response to alarms ........................................
Adopting alarm settings when changing the
ventilation mode ..............................................
Alarm delay and alarm escalation ...................
Alarm de-escalation.........................................
Activation of alarms after breath detection ......
101
102
104
106
108
109
Configuration................................................. 110
Device settings ................................................
Defining start settings......................................
Transferring device configurations ..................
Activating applications.....................................
Overview of configurable screen contents ......
111
111
129
130
130
Getting started ............................................... 59
Problem solving ............................................ 136
Switching on Perseus ...................................... 60
Checking readiness for operation.................... 61
Operation in case of emergency...................... 61
Locating and remedying leakage ....................
Power supply failure ........................................
Failure of the gas supply .................................
Failure of the gas mixer...................................
Ventilator failure ..............................................
Gas measurement failure ................................
Failure of flow measurement ...........................
Screen fault/user interface failure....................
Complete failure ..............................................
Problems with the anesthetic gas receiving
system (AGS) ..................................................
Problems with the pressure reducers..............
Problems with the Vapor View option..............
Alarm – Cause – Remedy ...............................
Operation........................................................ 62
Safety information............................................
Starting the therapy .........................................
Adjusting the therapy.......................................
Special forms of therapy..................................
Using fields with special functions ...................
Arranging the screen display ...........................
Viewing additional data....................................
Setting the volume...........................................
Adjusting the alarms ........................................
Instructions for use Perseus A500 SW 1.0n
63
64
66
69
71
75
79
81
81
137
138
140
141
141
142
142
142
143
143
144
144
145
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Contents
Cleaning, disinfection and sterilization....... 164
Disassembly ....................................................
Reprocessing procedures ...............................
Reprocessing list .............................................
Assembling the components ...........................
Before using on patients again........................
165
166
170
174
174
Maintenance................................................... 175
Overview .........................................................
Inspection ........................................................
Service ............................................................
Repairs ............................................................
176
176
178
179
Disposal ......................................................... 180
Disposing of the medical device...................... 181
Disposal of accessories................................... 181
Technical data ............................................... 182
Diagrams ......................................................... 198
EMC declaration.............................................. 201
Software license compliance (optional) ........... 206
Principles of operation ................................. 207
Description of the ventilation modes ...............
Influence of patient category, weight, and age
on device behavior ..........................................
Infinity ID accessory support ...........................
Schematic diagram of alarm tones..................
208
217
218
219
Annex ............................................................. 220
Abbreviations................................................... 221
Symbols........................................................... 223
Overview of the menu structure ...................... 226
Password ....................................................... 229
Configuration password for Perseus
A500 Software 1.0n......................................... 229
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Instructions for use Perseus A500 SW 1.0n
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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 .....................................................
Connection to other devices ............................
Connection to IT network.................................
Patient safety...................................................
Patient monitoring............................................
Information on electromagnetic compatibility ..
Training............................................................
Keeping the instructions for use ......................
8
8
8
8
9
9
10
10
10
11
11
Product-specific safety information ............ 11
Functional safety ............................................. 12
Handling Infinity ID components...................... 12
Instructions for use Perseus A500 SW 1.0n
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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
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
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 14) 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
Risk of medical device failure and patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts. Dräger recommends DrägerService
for a service contract and for performing
repairs. Dräger recommends using original
Dräger parts for maintenance.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter ''Maintenance''.
Safety checks
The medical device must be subject to regular
safety checks. See chapter ''Maintenance''.
Accessories
WARNING
Danger from incorrect accessories
Only the accessories in the list of accessories
9052630 (1st edition or higher) have been
tested and approved for use with the medical
device.
Therefore, it is urgently recommended that
the medical device only be used in
combination with these accessories.
Otherwise, the medical device may not
function properly.
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Instructions for use Perseus A500 SW 1.0n
Page 9
For your safety and that of your patients
WARNING
–
Risk of operating errors and incorrect use
Strictly observe the instructions for use of all
accessory parts, e.g.,:
– Water traps
– Flow sensors
– CLIC adapter
– CLIC absorber
– Soda lime
– Breathing hoses
– Masks
– Filters
– Endotracheal suction
– Vaporizer
– Emergency breathing bag
– AGSS terminal unit
Connection to other devices
Device combinations approved by Dräger meet the
requirements of the following standards:
–
IEC 60601-1 (3rd edition)
Medical electrical equipment
Part 1: General requirements for basic safety
and essential performance
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for basic
safety and essential performance
Collateral standard: Electromagnetic
compatibility; Requirements and tests
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for basic
safety and essential performance
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
If Dräger devices are connected to other Dräger
devices or third-party devices and the resulting
combination is not approved by Dräger, the correct
functioning of the devices may be compromised.
The operating organization is responsible for
ensuring that the resulting system meets the
requirements of the applicable standards.
Strictly observe assembly instructions and
instructions for use for each networked device.
Connection to IT network
The connection of the medical device to a network
or subsequent network changes can lead to
previously unidentified risks for patients, users,
and third parties. These risks must be identified
and tested before operating the medical device.
Relevant network changes are, among others:
–
Instructions for use Perseus A500 SW 1.0n
IEC 60601-1 (2nd edition)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility; Requirements and tests
– IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable
electrical medical systems
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for safety
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Configuration changes
9
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For your safety and that of your patients
–
Addition or removal of additional devices
–
Update or upgrade of connected devices
The Ethernet interfaces are only suitable for
connecting devices or networks with a rated
voltage of maximum 24 V DC that meet one of the
following requirements:
–
IEC 60950-1: Ungrounded SELV circuits
–
IEC 60601-1 (as of 2nd edition): Touchable
secondary circuits
Risks
An overload of the medical device due to a very
high network load (e.g., through denial-of-service
attacks) could lead to deactivation of the interface.
In this case, the service functions are not available
until the medical device is restarted. In rare cases,
a warm boot may take place and may occur
repeatedly.
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 users, and that certain
inherent characteristics of the medical device are
known to the user. 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 who operate this medical device as well as
references to the consequences of medical device
misuse, and to potentially adverse effects in
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.
Information on electromagnetic
compatibility
General information on electromagnetic
compatibility (EMC) according to the international
EMC standard IEC 60601-1-2:
Medical electric equipment is subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information provided (see page 201).
Portable and mobile RF communications
equipment can affect medical electrical equipment.
WARNING
Risk of electric shock
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 users must be instructed in these
ESD protective measures.
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Instructions for use Perseus A500 SW 1.0n
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For your safety and that of your patients
WARNING
Risk of device failure
Electromagnetic fields e.g., those generated
by radio frequency communication
equipment such as mobile phones, highfrequency electrical surgery equipment,
defibrillators or shortwave therapy devices
can disrupt the function of the medical
device.
Only operate radio frequency devices at a
sufficient safety clearance of at least 20 cm
(7.9 in).
Training
User trainings are offered by the responsible
Dräger organization, see www.draeger.com.
Keeping the instructions for use
CAUTION
Risk of operating errors
The instructions for use must be kept in an
accessible location for users.
Product-specific safety information
WARNING
WARNING
Risk due to device failure
Risk of fire
Device failure can compromise the correct
therapy functionality of the device.
To avoid a fire hazard, do not introduce drugs
or other substances based on flammable
solvents, such as alcohol, into the breathing
system and do not use explosive anesthetic
agents such as ether or cyclopropane or
spray them into 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 an emergency breathing
bag ready.
If highly flammable substances are used for
disinfection, adequate ventilation is required.
WARNING
Dräger recommends the user to remain 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 of malfunction
Unallowed modifications to the medical
device lead to malfunctions.
This medical device may not be changed
without permission from Dräger.
Instructions for use Perseus A500 SW 1.0n
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
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For your safety and that of your patients
WARNING
Risk of electric shock
If a USB storage medium with its own power
supply is used, failure of its protective
ground may raise the patient leakage current.
Only use USB storage media without their
own power supply as authorized by the list of
accessories.
Handling Infinity ID components
Ownership or purchase of this medical device with
RFID technology, only include 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 due to electromagnetic fields
Although Perseus does not exceed the valid
limit 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.
Functional safety
The essential performance features comprise:
–
Supply of the anesthesia workstation with O2
If the O2 supply (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 and the
expiratory minute volume
Alarms are issued depending on the set alarm
limits.
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Instructions for use Perseus A500 SW 1.0n
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Application
Application
Intended use .................................................. 14
Indications/Contraindications ...................... 14
Indications ....................................................... 14
Contraindications............................................. 14
Further information on application.............. 15
Environment of use.......................................... 15
Instructions for use Perseus A500 SW 1.0n
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Page 14
Application
Intended use
The anesthesia workstation Perseus 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.
Ventilation is accomplished on the patient through
a laryngeal mask, a 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).
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.
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.
14
–
For patients suspected of malignant
hypothermia: Do not use any volatile
anesthetic agent or Perseus with residual
concentrations of these gases above 5 ppm.
–
Do not conduct low-flow anesthesia on patients
with ketoacidosis, or patients under the
influence of alcohol. This will raise the 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.
Instructions for use Perseus A500 SW 1.0n
Page 15
Application
Further information on application
Environment of use
Perseus is conceived for use in rooms in which
therapeutic or diagnostic interventions can be
carried out.
WARNING
Risk of explosion
This medical device is neither approved nor
certified for use in areas where oxygen
concentrations greater than 25 %,
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 near nuclear
magnetic resonance imaging (MRT, NMR,
NMI).
Also, do not use Perseus in the following
environments:
–
outside of massive buildings
–
on intensive care units
–
during patient transport
–
in vehicles, airplanes, or helicopters
Instructions for use Perseus A500 SW 1.0n
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Overview
Overview
Hardware ........................................................
17
Front ................................................................
The screen ......................................................
Plug-in connection for vaporizers with option
Vapor View ......................................................
Breathing system.............................................
Side view from left ...........................................
Device column.................................................
Rear.................................................................
Interfaces.........................................................
Gas inlets ........................................................
Auxiliary power sockets...................................
Mixer unit.........................................................
17
18
Functional scope...........................................
27
Options and accessories .................................
Gas dosage .....................................................
Ventilation modes............................................
Additional operation modes.............................
Monitoring........................................................
Display on the screen......................................
Protocoling ......................................................
Gas supply ......................................................
Gas scavenging...............................................
Data exchange, interfaces...............................
27
27
27
27
27
27
28
28
28
28
16
18
19
20
21
22
23
24
25
26
Instructions for use Perseus A500 SW 1.0n
Page 17
Overview
Hardware
Front
A
B
M
L
K
C
D
J
I
E
H
F
10335
G
A Screen with illumination
J
CO2 absorber
B Mixer unit
K APL valve
C Work surface
L External fresh-gas outlet (optional)
D Extensible writing tray with compartment for
instructions for use (optional)
M Plug-in connection for vaporizers with option
Vapor View
E Central brake
F Castors with central brake
G Footrest
H Trolley
I
Anesthetic gas receiving system with flow
indicator
Instructions for use Perseus A500 SW 1.0n
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Page 18
Overview
The screen
B Audio paused key
to suppress the alarm
tones of all active alarms for 2 minutes
C Rotary knob with background illumination to
select and confirm settings
D Key
for switching the work light on or off
and dimming the illumination in 4 steps (off,
dark, medium, and bright)
A
E Key
E
D
B
10340
C
for switching the device on or off
A Touch screen to call up functions or dialog
windows
Plug-in connection for vaporizers with option Vapor View
B
10397
A
A Sensor unit
B Illumination unit
18
Instructions for use Perseus A500 SW 1.0n
Page 19
Overview
Breathing system
A
B
C
D
E
F
G
10370
H
A Water trap with connection for sample line
B Inspiratory port
C Bag elbow with cone for occluding purposes
e.g., for leakage test
D APL valve
E Expiratory port
F Holder for breathing bag hose
G CO2 absorber
H Anesthetic gas receiving system
Instructions for use Perseus A500 SW 1.0n
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Overview
Side view from left
C
A
10337
B
A GCX rail for mounting additional workstation
components
B Strain relief for AGS hose, adjustable height
C External fresh-gas outlet (optional)
20
Instructions for use Perseus A500 SW 1.0n
Page 21
Overview
Device column
The following illustration shows the left side of the
device:
A
B
F
E
D
10369
C
A Column cover
B GCX rail
C Recesses for cables which lead e.g., into the
device arms
D Screw for closing the cable conduit lid
E Tabs to hold the cable
F Cable conduit
Instructions for use Perseus A500 SW 1.0n
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Overview
Rear
A
H
B
A
A
G
C
F
D
E
E
10336
D
A Standard rail
B Gas inlets
C Strain relief for compressed gas hose
D Connection possibility for 38 mm tube
(optional)
E Castor with castor brake
F Gas cylinder holders (optional) with Velcro
strap to secure gas cylinders
G Interfaces
H Rating plate
22
Instructions for use Perseus A500 SW 1.0n
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Overview
Interfaces
A
B
D
E
F
10367
G
C
A Device switch
B Serial interfaces (COM 1 and COM 2)
C USB interface
D Network interface
E Interface for work light (optional)
F IEC connector (socket for power cable)
G Potential equalization pin
Instructions for use Perseus A500 SW 1.0n
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Overview
Gas inlets
C
B
A Connections for gas pressure measurement of
gas cylinders (optional)
B Connections for central gas supply (N2O
optional)
C Connections for external gas cylinders
(optional)
24
Instructions for use Perseus A500 SW 1.0n
10338
A
Page 25
Overview
Auxiliary power sockets
View with column cover removed:
A
B
10368
C
A Auxiliary power sockets, depending on
equipment variant
B Isolation transformer switch (optional)
C Circuit breakers or fuses, depending on
equipment variant
Instructions for use Perseus A500 SW 1.0n
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