zeus_infinity_empowered_instructions_for_use_sw_1-n.pdf
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Instructions for Use
Zeus Infinity Empowered
WARNING
For a full understanding of the
performance characteristics of this
medical device, the user should
carefully read these Instructions for
Use before use of the medical device.
Anesthesia Workstation System
Software 1.n
Page 2
Working with these Instructions for Use
The title of the main chapter in the header line
helps to orient and navigate quickly.
The Instructions for Use in a combination of text
and pictures provide the user with a comprehensive
overview of the system. The information is
presented as action steps which the user can
implement directly on the device.
The text gives explanations and guides the user
unambiguously with brief instructions in an
ergonomic sequence to the benefits of the product.
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.
–
Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
related illustration.
The illustrations establish the relationship
between text and device. Elements mentioned in
the text are highlighted; unimportant details are
dispensed with.
Schematic screen displays guide the user and
confirm the action steps. Schematic renderings of
screen images are used, which may differ in
appearance or in configuration from the actual
screen images.
A Letters identify elements referred to in the text.
Typographical Conventions
Any text appearing on the screen and any labeling
on the device are printed in bold and italics, for
example, PEEP, or MixGas settings.
The "greater than" symbol > indicates the
navigation path in a dialog window, for example,
Screen setup > Screen layout > General. In this
example, Screen setup represents the dialog
window title, Screen layout represents a
horizontally aligned tab, and General a vertically
aligned tab.
These Instructions for Use apply to the Zeus Infinity
Empowered
In these Instructions for Use, only the term
"Zeus IE" is used.
Trademarks
–
–
–
–
–
–
–
–
2
AutoFlow®
Drägersorb® 800 Plus
Drägersorb® Free
Forta®
SpiroLife®
VacuSmart®
Zeus®
Infinity®
are registered trademarksof Dräger.
–
–
–
IVDock™
Trident™
Dräger Fill™
are protected trademarks of Dräger.
–
BIS™
Instructions for Use Zeus Infinity Empowered SW 1.n
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–
Bispectral Index ™
are protected trademarks of Aspect Medical
Systems Inc.
–
Quik Fil®
is a registered trademark of Abbott Laboratories.
–
Masimo®
–
Masimo SET®
–
Signal Extraction Technology (SET)®
are registered trademarks of Masimo Corporation.
–
Nellcor®
–
Nellcor OxiMax
registered trademarks of Covidian.
Saf-T-Fill™
is a protected trademark of Baxter.
Definition
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 of the
medical device.
Abbreviations and Symbols
Explanations can be found in the chapters
"Abbreviations" on page 27 and "Symbols"
on page 32.
Instructions for Use Zeus Infinity Empowered SW 1.n
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Instructions for Use Zeus Infinity Empowered SW 1.n
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Contents
Contents
For Your Safety and that of Your Patients . .
7
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Automatic self test (Auto self test). . . . . . . . . . 84
Pretest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Displaying the test results . . . . . . . . . . . . . . . . 85
Displaying the test results during operation . . 88
Starting in emergencies. . . . . . . . . . . . . . . . . . 89
System overview . . . . . . . . . . . . . . . . . . . . . . 19
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
91
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Start settings . . . . . . . . . . . . . . . . . . . . . . . . . .
Changing patient data . . . . . . . . . . . . . . . . . . .
Gas delivery . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Web access (optional) . . . . . . . . . . . . . . . . . . .
IV system – IVenus . . . . . . . . . . . . . . . . . . . . .
End of operation . . . . . . . . . . . . . . . . . . . . . . .
92
94
97
102
115
116
130
General Safety Information. . . . . . . . . . . . . . . . 10
Delivery form and processing to make it
ready for use. . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Operating concept . . . . . . . . . . . . . . . . . . . . . 35
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen layout . . . . . . . . . . . . . . . . . . . . . . . . . .
Using the touch screen. . . . . . . . . . . . . . . . . . .
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview of the menu structure . . . . . . . . . . . .
36
37
39
40
41
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Before initial use . . . . . . . . . . . . . . . . . . . . . . . .
Zeus IE as ceiling unit . . . . . . . . . . . . . . . . . . .
Establishing electrical connections. . . . . . . . . .
Establishing the gas supply . . . . . . . . . . . . . . .
Connecting anesthetic gas receiving system
(AGS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replacing or filling the CO2 absorber . . . . . . . .
Connecting hoses. . . . . . . . . . . . . . . . . . . . . . .
Preparing optional patient monitoring. . . . . . . .
Connecting IV system. . . . . . . . . . . . . . . . . . . .
DIVA metering modules for anesthetic
agents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIVA metering module with Dräger Fill filling
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIVA metering module with safety filling
device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sevoflurane safety filling system Quik Fil . . . . .
Filling system for desflurane. . . . . . . . . . . . . . .
50
51
51
53
54
55
57
60
61
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Alarm behaviour at power on . . . . . . . . . . . . .
Display alarms. . . . . . . . . . . . . . . . . . . . . . . . .
Alarm info . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm log . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suspending alarms . . . . . . . . . . . . . . . . . . . . .
Alarm recorder (optional with hemodynamic
and Infinity network) . . . . . . . . . . . . . . . . . . . .
All limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Autoset limits . . . . . . . . . . . . . . . . . . . . . . . . . .
Suppressing the alarm tone . . . . . . . . . . . . . .
Set ranges of the patient monitoring alarm
limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trends and diagnosis windows . . . . . . . . . . . .
134
134
135
135
136
139
140
141
145
148
150
154
62
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
65
Overview of the monitoring . . . . . . . . . . . . . . . 158
Device monitoring . . . . . . . . . . . . . . . . . . . . . . 159
Patient monitoring . . . . . . . . . . . . . . . . . . . . . . 165
67
71
73
Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Switching on Zeus IE . . . . . . . . . . . . . . . . . . . . 79
Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Instructions for Use Zeus Infinity Empowered SW 1.n
Fault - Cause - Remedy. . . . . . . . . . . . . . . . . 213
Failure behavior. . . . . . . . . . . . . . . . . . . . . . . .
Power outage . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply failure . . . . . . . . . . . . . . . . . . . . . .
Ventilator failure. . . . . . . . . . . . . . . . . . . . . . . .
Anesthetic gas delivery failure (DIVA failure) .
214
214
215
215
216
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Contents
Mixer and DIVA failure . . . . . . . . . . . . . . . . . . . 216
Rotary safety knob Anaesth. Ventilator
Emerg. Off for ventilation . . . . . . . . . . . . . . . . . 216
In the event of partial system failures . . . . . . . . 217
In the event of device failure . . . . . . . . . . . . . . 218
Failure behavior DPS . . . . . . . . . . . . . . . . . . . . 218
Messages Zeus IE . . . . . . . . . . . . . . . . . . . . . . 218
Metering module faults . . . . . . . . . . . . . . . . . . . 274
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 279
Configuration information . . . . . . . . . . . . . . . . . 280
System setup . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Configuring the screen . . . . . . . . . . . . . . . . . . . 287
Configuring basic settings . . . . . . . . . . . . . . . . 291
Other functions of the system. . . . . . . . . . . . . . 306
Service functions . . . . . . . . . . . . . . . . . . . . . . . 308
Cleaning, disinfection, and sterilization. . . . 309
Safety information on reprocessing . . . . . . . . . 310
Hygiene precautions. . . . . . . . . . . . . . . . . . . . . 310
Care instructions for monitoring accessories . . 315
Dismantling components . . . . . . . . . . . . . . . . . 317
Care list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 329
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 332
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335
Gas delivery, control mode Auto control . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Breathing system. . . . . . . . . . . . . . . . . . . . . . .
Fresh-gas outlet for non-rebreathing system
(optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Airway resistances . . . . . . . . . . . . . . . . . . . . .
Measuring system . . . . . . . . . . . . . . . . . . . . . .
O2-, CO2 and anesthetic gas measurement . .
Anesthetic gas measurement (infrared
spectroscopy) . . . . . . . . . . . . . . . . . . . . . . . . .
Anesthetic gas metering modules . . . . . . . . . .
Data communication . . . . . . . . . . . . . . . . . . . .
Relevant standards . . . . . . . . . . . . . . . . . . . . .
Modules for patient monitoring . . . . . . . . . . . .
Hemodynamic modules. . . . . . . . . . . . . . . . . .
Trident Pod (NMT). . . . . . . . . . . . . . . . . . . . . .
BISx pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring specifications . . . . . . . . . . . . . . . . .
ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-invasive blood pressure measurement
(NIBP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Invasive blood pressure (IBP) . . . . . . . . . . . . .
Wedge measurement . . . . . . . . . . . . . . . . . . .
Cardiac output (C.O.) . . . . . . . . . . . . . . . . . . .
Pulse oximetry (SpO2). . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . .
Neuromuscular Transmission Monitoring
NMT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anesthesia depth monitoring BIS . . . . . . . . . .
EMC declaration . . . . . . . . . . . . . . . . . . . . . . .
346
347
349
349
350
350
352
353
354
354
355
356
356
357
358
359
359
360
362
363
363
363
366
366
368
369
Description. . . . . . . . . . . . . . . . . . . . . . . . . . . 373
Safety Information . . . . . . . . . . . . . . . . . . . . . . 336
Disposing of batteries. . . . . . . . . . . . . . . . . . . . 336
Disposing of disposable articles . . . . . . . . . . . . 336
Disposal of the Medical Device . . . . . . . . . . . . 337
Gas flow diagram . . . . . . . . . . . . . . . . . . . . . .
Gas control loops . . . . . . . . . . . . . . . . . . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation modes . . . . . . . . . . . . . . . . . . . . . .
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
374
375
380
380
385
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 339
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389
Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . 340
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 340
Latex-free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341
Penetration values of IBF filter . . . . . . . . . . . . . 341
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 341
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 342
Central gas supply . . . . . . . . . . . . . . . . . . . . . . 343
Gas delivery, control mode FG ctrl. . . . . . . . . . 345
6
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 7
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use . . . . . . 8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety inspections . . . . . . . . . . . . . . . . . . . . . . 8
Metrological controls* . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connected devices . . . . . . . . . . . . . . . . . . . . . . 8
Not for use in areas of explosion hazard . . . . . 9
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9
Essential performance . . . . . . . . . . . . . . . . . . . 10
General Safety Information . . . . . . . . . . . . . . 10
Note on the EMC/ESD hazard to device
function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Sterile-packaged accessories. . . . . . . . . . . . . . 12
Alternative monitoring. . . . . . . . . . . . . . . . . . . . 13
Delivery form and processing to make it
ready for use . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Instructions for Use Zeus Infinity Empowered SW 1.n
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Page 8
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
WARNING
Any use of the medical device requires full
understanding and strict observation of all
sections of these Instructions for Use. The
medical device must only be used for the
purpose specified under "Intended Use"
on page 16 and in conjunction with
appropriate patient monitoring (see page 9).
Strictly observe all WARNING and CAUTION
statements throughout these Instructions for
Use and all statements on medical device
labels.
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by trained personnel.
Repair of the medical device may also only be
carried out by trained personnel.
Dräger recommends that a service contract be
obtained with DrägerService and that all
repairs also be carried out by them. Dräger
recommends that only authentic Dräger repair
parts be used for maintenance and that the
Remote Service be used. Otherwise, the
correct functioning of the medical device may
be compromised.
See chapter "Maintenance".
Metrological controls*
Subject the medical device to regular metrological
controls in accordance with the German Medical
Devices Operator Ordinance (MPBetreibV) (see
"Inspection" on page 331).
Accessories
WARNING
Only the accessories indicated on the list of
accessories 90 52 018 (1st edition or later)
have been tested and approved for use with
the medical device.
Therefore, it is strongly recommended that the
medical device is only used in conjunction
with the corresponding accessories.
Otherwise, the correct functioning of the
medical device may be compromised.
Connected devices
WARNING
Any connected devices or device
combinations not complying with the
requirements mentioned in these Instructions
for Use may compromise the proper
functioning of the medical device. Before
starting the medical device, read the
respective documentation and the
Instructions for Use for all connected devices
or device combinations.
Safety inspections*
Subject the medical device to regular safety
inspections in accordance with the German
Medical Devices Operator Ordinance
(MPBetreibV) (see "Inspection" on page 331).
*
8
Only applies in the Federal Republic of Germany
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 9
For Your Safety and that of Your Patients
Not for use in areas of explosion hazard
WARNING
The medical device is not approved for use in
areas of explosion hazard.
Safe connection with other electrical
equipment
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these Instructions for Use may only be made after
consultation with each respective manufacturer.
Networking
Device combinations approved by Dräger (see
Instructions for Use for the individual devices or
units) meet the requirements of the following
standards:
–
IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
–
IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
–
–
IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility; Requirements and tests
IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
If Dräger devices or units are connected to other
Dräger devices or third-party devices and the
resulting combination is not approved by Dräger,
Instructions for Use Zeus Infinity Empowered SW 1.n
the correct functioning of the devices may be
compromised. The owner is responsible for
ensuring that the resulting system meets the
requirements of the above-mentioned standards.
Strictly observe the Assembly Instructions and
Instructions for Use for each networked device!
Patient safety
The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to trained professionals, and that
certain inherent characteristics of the medical
device are known to the trained user. Instructions
for use 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
a medical professional who operates this medical
device nor references to the consequences of
medical device misuse, and to potentially adverse
effects in patients with different underlying
diseases. Modification or misuse of the medical
device can be dangerous.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
Patient monitoring
The user of the medical device is responsible for
choosing suitable monitoring that provides
appropriate information about medical device
performance and the patient's condition.
Patient safety may be achieved by a wide variety of
means ranging from electronic surveillance of
medical device performance and patient condition
to simple, direct observation of clinical signs.
9
Page 10
For Your Safety and that of Your Patients
The responsibility for selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Essential performance
The essential performance consists of
–
controlled and monitored patient ventilation
–
and anesthetic agent delivery
with user-defined settings for the monitoring
functions:
–
minimum breathing gas flow
–
maximum airway pressure
–
minimum and maximum O2 concentration in
the breathing gas,
–
minimum and maximum anesthetic agent
concentration in the breathing gas
or
–
if a set limit is exceeded, by an appropriate
alarm.
The medical device is equipped with basic safety
features to reduce the possibility of patient injury
while the cause of an alarm is remedied.
General Safety Information
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
Instructions for Use or in the Instructions for Use of
another product being used with this device.
WARNING
Only use the Zeus IE anesthesia workstation
with constant supervision by qualified
medical personnel in order to intervene
immediately in the event of a malfunction.
Note on the EMC/ESD hazard to device
function
General information on the electromagnetic
compatibility EMC/ESD declaration according to
the international EMC standard IEC 60601-1-2:
installed and put into operation in accordance with
the EMC information provided in the technical
documentation, see page 369.
Portable and mobile RF communications
equipment can affect medical electrical equipment.
WARNING
Pins of connectors carrying an ESD
warning symbol (electrostatic
discharge) must not be touched or
connections made between these connectors
without ESD protective measures being
applied. Such protective measures may
include antistatic clothing and shoes,
touching a ground stud before and during
connection of the pins, or using electrically
insulating and antistatic gloves. All relevant
personnel should be instructed in these ESD
protective measures.
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
10
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 11
For Your Safety and that of Your Patients
WARNING
Danger of electric shock to user and patient.
Connection of devices to the auxiliary sockets
of the anesthesia device can cause an
increase in the patient discharge current
beyond the permissible value if the protective
conductor of a device fails. Therefore, check
the entire discharge current when connecting.
When the permissible values for the entire
discharge current are exceeded, devices must
not be connected to the auxiliary sockets of
the anesthesia device, but to a separate wall
socket.
The system must meet the requirements for
medical electrical equipment according to the
IEC/EN 60601-1-1 and IEC/EN 60601-1-2
standards.
WARNING
Risk of burns.
Do not use humidifiers or heated hoses!
WARNING
Fire hazard.
Drugs or other substances based on
combustible solvents such as alcohol must
not be introduced to the patient system.
WARNING
Risk of strangulation.
Portable and mobile HF communication equipment
can influence medical devices!
Only device combinations released according to
Medical Devices Directive 93/42/EEC may be
used.
WARNING
Device contamination possible.
Only operate Zeus IE with airway filters.
WARNING
Risk of burns when using HF surgery
equipment.
Do not use antistatic or conductive breathing
hoses.
WARNING
Risk of patient injury
When using near-patient filters do not
scavenge at the patient end! In the event of
stenosis or increased filter resistance the
patient may be injured by vacuum.
WARNING
Risk of equipment malfunction.
Only have network functions configured by
authorized, trained personnel.
Errors in configuration can impair operation
of the device and the network.
Make connection to the patient carefully.
WARNING
Fire hazard.
Do not use any explosive anesthetic agents
such as ether or cyclopropane.
WARNING
Zeus IE must not be used with magnetic
resonance imaging (MRT, NMR, NMI)! Device
operation may be affected, thus placing the
patient at risk.
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Page 12
For Your Safety and that of Your Patients
WARNING
Risk of patient injury
NOTE
Risk of injury.
The following operating states are prohibited
when the patient is connected:
– Standby
– Self test
– Leak test
– Leakage assistant
– Pretest
– Service mode.
Handle the DIVA metering module with care and
prevent it from tilting and falling down.
No monitoring is possible in these operating
states. During the test, pressures and
concentrations may occur in the system
which are hazardous to the patient!
CAUTION
Health risk.
Operate Zeus IE with connected anesthetic gas
scavenging system (AGSS) only.
CAUTION
Do not use silicone spray! Silicone spray can
cause breathing system valves to stick.
CAUTION
Do not use DIVA metering modules which have
been dropped or damaged. Any damage can
result in faulty metering.
CAUTION
Risk of tipping over.
When transporting the device and all the hinged
arms are swung inward to the center of the device
and locked, ensure that the slope of the floor does
not exceed ±10°.
If the transport position is not observed, the
maximum slope of the floor is reduced to ±5°.
NOTE
Operate in sufficiently ventilated rooms or the CO2
measurement may otherwise be impaired.
NOTE
The ambient conditions specified in the Technical
Data must be observed during operation and
storage of the device.
NOTE
There may be a restriction of ambient conditions
owing to mounted accessories or specifications
issued by the anesthetic agent manufacturer.
NOTE
In a closed system, foreign gases can accumulate
in the breathing gas with longer surgery times,
e.g., by decomposition of the breathing gas.
Increased concentrations of foreign gases can be
prevented by regularly flushing the breathing
system.
Sterile-packaged accessories
CAUTION
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged or there
are other signs of non-sterility. Single-use articles
must not be reprocessed and resterilized.
Reuse, reprocessing, or sterilization may lead to
failure of the medical devices and injury to the
patient.
NOTE
Do not cover or close off the vents on the device.
Make sure there is an adequate supply of air.
Otherwise, the device may overheat.
12
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 13
For Your Safety and that of Your Patients
Alternative monitoring
In the event of a failure of individual monitoring
functions, appropriate alternative monitoring must
be provided. Patient monitoring (ECG, SpO2, etc.)
must be used according to the customary
recommendations in the particular country.
CAUTION
Risk of patient injury
Individual measuring and trend values may be
evaluated only in the context of other measuring
and metering parameters. Otherwise, artefacts
and erroneous measuring and trend values for an
individual parameter could lead to a false
diagnosis when assessing the patient.
Delivery form and processing to make it ready for use
Before the first use, the Zeus IE anesthesia
workstation system must be equipped with the
accessories required for operation as well as other
devices required for use, e.g., patient monitoring.
The required connections must be established with
the supply lines (power supply, Air, N2O, O2,
anesthetic gas scavenging system).
Charge the internal battery for at least 10 hours
before the first startup.
Before every use, Zeus IE must be equipped
according to the specifications in the Instructions
for Use.
Zeus IE goes through an internal self test after each
power-on. The self test must be performed once a
day as well as after servicing and when replacing
parts. Perform a leak test before a patient change
when replacing the breathing hoses.
Before operation, at least the measurement
displays of the following parameters have to be
configured on the screen in accordance with the
requirements of national standards (see
IEC 60601-2-13):
– FiO2
– etCO2
– inVA
– MV
– Airway pressure
Instructions for Use Zeus Infinity Empowered SW 1.n
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14
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 15
Application
Application
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . .
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . .
Device monitoring. . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring (optional). . . . . . . . . . . . . . .
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas disposal. . . . . . . . . . . . . . . . . . . . . . . . . . .
Data exchange, interfaces . . . . . . . . . . . . . . . .
Breathing system . . . . . . . . . . . . . . . . . . . . . . .
16
16
16
16
17
17
17
17
18
18
Instructions for Use Zeus Infinity Empowered SW 1.n
15
Page 16
Application
Intended Use
Ventilation modes
Zeus IE enables all forms of general anesthesia
(inhalation anesthesia, balanced anesthesia and
total intravenous anesthesia) and regional
anesthesia, as well as the monitoring of regional
anesthesia.
Volume-controlled ventilation at constant
inspiration flow Volume Control
Anesthesia is conducted with automatic ventilation,
manual ventilation or spontaneous breathing with
an oxygen ratio of at least 25 %, using a mixture of
Air (medical compressed air) or nitrousoxide with
pure oxygen and additional delivery of volatile
anesthetic agents and/or intravenous drugs.
Volume-controlled ventilation at decelerating
inspiration flow Volume Control AutoFlow,
synchronization of ventilation breaths Sync.(VC)
and Pressure Support if required.
Pressure-controlled ventilation Pressure Control,
synchronization of ventilation breaths Sync.(PC)
and Pressure Support if required.
Pressure-supported ventilation at constant positive
airway pressure Pressure Support
Application
Manual ventilation/spontaneous breathing with and
without CPAP MAN/SPON
The Anesthesia Workstation System Zeus IE is
designed for use in medical rooms, operating
rooms and induction and recovery rooms.
Device monitoring
Applications range from adults to pediatric patients
and neonates.
Ventilation is performed on the patient using a
laryngeal mask, a mask or an endotracheal tube.
The breathing system can be used either with
partial rebreathing (low flow or minimal flow) or with
complete rebreathing (closed system).
Non-rebreathing system with external fresh-gas
outlet, for manual ventilation for connection to Bain
or Magill system for example (optional).
Zeus IE is equipped with modules for drug
metering, for patient and device monitoring and for
ventilation.
The following are indicated as measured
values:
–
–
–
–
–
–
–
–
–
–
–
Airway pressure PIP
Airway pressure Plat
Airway pressure PEEP
Airway pressure Mean
Minute volume MV
Tidal volume VT
Respiratory rate RR
CO2, inspiratory and expiratory
O2, inspiratory and expiratory
N2O, inspiratory and expiratory
Anesthetic agent concentration, inspiratory and
expiratory
The following are represented as curves:
–
–
–
–
–
Airway pressure Paw
Inspiratory and expiratory flow or volume curves
Capnogram
Oxigram
PV FV Loops
Additionally there are chronological trends of
measured values (trends) as well as a log book
available.
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Instructions for Use Zeus Infinity Empowered SW 1.n
Page 17
Application
Patient monitoring (optional)
The following are indicated as measured
values:
–
–
–
–
–
–
–
–
–
–
Heart rate ECG HR/PLS
ST segment ST segm.
Oxygen saturation SpO2
Non-invasive blood pressure NIBP
Invasive blood pressure IBP
Cardiac output C.O./ Calculat.
Temperature Temp
Degree of muscle relaxation: Single, TOF, PTC
Depth of hypnosis BIS
Wedge pressure PWP
Patient monitoring*
–
–
–
–
–
–
–
–
–
Heart rate HR
ST segment ST
Oxygen saturation SpO2
Non-invasive blood pressure NIBP
Invasive blood pressure IBP
Temperature T1, T2
Relaxometry measurement TOF
Depth of hypnosis measurement BIS
Arrhythmia detection (optional)
Applicable inhalation anesthetic agents
–
–
–
Isoflurane
Sevoflurane
Desflurane
The following are represented as curves:
–
–
–
–
Electrocardiogram ECG (up to 3 curves)
Plethysmogram SpO2
Invasive blood pressure IBP (up to 10 curves)
Electroencephalogram EEG
Additionally there are chronological trends of
measured values (trends) as well as a log book
available.
Monitoring
The monitoring of the patient is ensured by
adjustable alarm limits.
Device monitoring
–
–
–
–
–
–
–
–
Airway pressure Paw
Expiratory minute volume MVe
Apnea
Tidal volume, inspiratory VTi
Inspiratory anesthesia gas concentration
Recognition of anesthesia gas mixtures
Inspiratory O2 and N2O concentrations FiO2,
inN2O
Inspiratory and expiratory CO2 concentrations
inCO2, etCO2
Applicable intravenous drugs
All suitable medications permitted for anesthesia
and for metering with syringe pumps (optional).
Applicable gas mixtures for the carrier gas
–
–
Gas supply
The plug formats of the Zeus IE anesthesia
workstation are selectable and comply with the
customary formats in the particular country.
Zeus IE has connections for O2, Air or N2O backup
gas cylinders, which must be equipped with
pressure reducers and pressure sensors.
Gas disposal
The anesthetic gas receiving system (AGS) must
be used as a required accessory. The AGS is
connected to an appropriately marked connecting
nozzle on Zeus IE.
*
Instructions for Use Zeus Infinity Empowered SW 1.n
O2/Air
O2/N2O
depending on the options installed
17
Page 18
Application
Data exchange, interfaces
For data communication there are two serial ports,
COM1 and COM2, using the Dräger MEDIBUS
data protocol.
USB interfaces for e.g., import/export of device
setups
An Infinity network connection in conjunction with
patient monitoring (optional).
Two network interfaces for remote diagnosis,
printers and web applications, e.g., WebView
(optional).
Breathing system
Interfaces to the patient are the 22 mm ∅-sockets
on the breathing system for the connection of
EN 12342-compliant breathing hoses.
For breathing systems without rebreathing, e.g.,
Bain system, an external fresh-gas outlet is
available (optional).
18
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 19
System overview
System overview
Components . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Breathing system view . . . . . . . . . . . . . . . . . . .
Connection for oxygen therapy. . . . . . . . . . . . .
Connection field for patient monitoring and
IV system (optional) . . . . . . . . . . . . . . . . . . . . .
Rear with doors open . . . . . . . . . . . . . . . . . . . .
Connections to the gas supply block . . . . . . . .
Connections to the back of the device
Zeus IE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connections to the back of the screen . . . . . . .
Connections, power supply and additional
sockets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIVA metering modules . . . . . . . . . . . . . . . . . .
20
21
21
21
23
24
25
25
26
26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 27
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Instructions for Use Zeus Infinity Empowered SW 1.n
19
Page 20
System overview
Components
Front
A
P
O
N
M
L
K
J
I
H
B
C
D
E
001
F
G
A Control panel – screen
K External fresh-gas outlet, optional
B Transport handles
L O2 flow meter for regional anesthesia
C Pull-out writing table
M Self-test adapter
D DIVA metering modules, 2 pieces
N Breathing system with APL valve
E Unlock buttons for DIVA metering modules
O Bracket with infusion apparatus stand
F Central brake
P IV system (IVenus) consisting of: IVDock
(basis) and up to 4 syringe pumps Module DPS
(Dynamic Pressure System), optional
G Drawer
H Endotracheal suction system
I
Disposable absorber Drägersorb CLIC
(or reusable absorber)
J
Output from O2 flow meter
20
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 21
System overview
Breathing system view
A B C
Connection for oxygen therapy
D
A
E
F
G
H
I
J
O
N
M
L
A
O2
211
K
B Mechanical pressure gauge for airway pressure
212
A O2 flush button O2+
D Safety rotary knob for O2 emergency delivery
Safety-O2
The additional oxygen flow meter (A) delivers a set
flow of pure oxygen, e.g., for oxygen metering
through a nasal cannula. The supplemental oxygen
can be used in each ventilation mode:
– Standby
– Zeus IE off,
E APL valve
as long as the central O2 supply is connected.
C Safety rotary knob Anaesth. Ventilator Emerg.
Off
F Self-test adapter
G O2 flow meter for regional anesthesia
H Output from O2 flow meter
I
J
External fresh-gas outlet (ext. FG outlet),
optional
Connection field for patient monitoring
and IV system (optional)
SpO2 measurement with SmartPod SpO2
Expiration nozzle
K Breathing bag nozzle
L CO2 absorber
M Protect water trap
147
Connection of internal sample line to
the Protect water trap
N CO2 water trap with connection point for sample
line
Connection of sample line to the CO2
water trap
O Inspiration nozzle
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System overview
HEMOMED 1
MULTIMED
Aux / Hemo 2
Aux / Hemo 3
SpO2
146
NIBP
SpO2 measurement without SpO2 SmartPod
(optional)
IV-System
Sync.
MULTIMED
009
HEMOMED 1
MULTIMED
Connection for accessories to
measure electrocardiography
(ECG HR/PLS) and body
temperature (Temp)
HEMOMED 1 Connection for accessories to
measure invasive blood pressures
(IBP) and cardiac output (C.O.)
Aux/Hemo 2/3 Connection for accessories to
measure more invasive blood
pressures (More IBP) and cardiac
output (C.O./ Calculat.)
Aux / Hemo 2
NIBP
Aux / Hemo 3
Sync.
IV-System
NIBP
Connection for accessories to
measure non-invasive blood
pressure (NIBP)
SpO2
Connection for accessories to
measure oxygen saturation (SpO2)
according to the technology marked
(Masimo SET oder Nellcor OxiMax)
Sync.
Connection for synchronization of a
defibrillator
IV system
Connection for Dräger IV system
(IVenus)
010
Connection for anesthesia effect
monitoring accessories (Trident
pod, BISx pod)
Without optional patient monitoring, only the
connection to the optional IV system is installed.
22
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 23
System overview
MULTIMED
Connection for accessories to
measure oxygen saturation (SpO2),
electrocardiography (ECG
HR/PLS), and body temperature
(Temp)
Rear with doors open
A
HEMOMED 1 Connection for accessories to
measure invasive blood pressures
(IBP) and cardiac output (C.O.)
I
Aux/Hemo 2/3 Connection for accessories to
measure more invasive blood
pressures (More IBP) and cardiac
output (C.O./ Calculat.)
H
E
E
Connection for anesthesia effect
monitoring accessories (Trident
pod, BISx pod)
B
C
D
E
F
G
Connection for accessories to
measure non-invasive blood
pressure (NIBP)
Sync.
Connection for synchronization of a
defibrillator
A Receptacle for cylinder pressure reducer
IV system
Connection for Dräger IV system
(IVenus)
C Backup gas cylinders with pressure reducers
173
NIBP
Without optional patient monitoring, only the
connection to the optional IV system is installed.
B Gas supply block
D Waste gas connector
E 3 ports for DrägerService (behind the left
backup gas cylinder and above the AGS)
F Anesthetic gas receiving system (AGS)
G Auxiliary sockets
H Circuit breaker
Use only in an emergency to interrupt battery
charging and to switch off the device with the
exception of the screen. To disconnect the
entire device from the power supply, unplug the
mains plug.
I
Instructions for Use Zeus Infinity Empowered SW 1.n
Electrical connections for cylinder pressure
sensors
23
Page 24
System overview
Connections to the gas supply block
B
C
D
E
F
084
A
A Connection of central N2O supply
B Connection for N2O backup gas cylinder
C Connection of central Air supply
D Connection for Air backup gas cylinder
E Connection of central O2 supply
F Connection of O2 backup gas cylinder
The Air outlet option and the O2 outlet option are
not shown in this figure.
24
Instructions for Use Zeus Infinity Empowered SW 1.n
Page 25
System overview
Connections to the back of the device
Zeus IE
Connections to the back of the screen
CAUTION
Unsupported USB devices
USB devices that are not supported or have too
high a current consumption can impair correct
equipment operation.
Only use supported USB devices with a maximum
current consumption of 500 mA.
CAUTION
USB devices with their own mains supply
USB devices with their own mains supply (e.g.
USB printers) can endanger patients and users.
B
C
D
026
A
Only connect passive USB devices to the
Zeus IE.
View with doors open.
Ports relevant to the user:
A COM 1, RS 232 interface, MEDIBUS
B COM 2, RS 232 interface, MEDIBUS
C Ethernet 3, Infinity Network socket
D Ethernet 1 and Ethernet 2, hospital network
port, optional
Only connect printers which have been approved
by Dräger to the Ethernet 1 port.
(see Printer settings page 295)
C
A
B
C
025
CAUTION
User intervention in internal device interfaces is
prohibited. This may impair correct functioning of
the device.
A COM 1, COM 2
B USB ports
C One USB port on each side
Instructions for Use Zeus Infinity Empowered SW 1.n
25