zeus_infinity_empowered_instructions_for_use_sw_2-n.pdf
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Instructions for use
Zeus Infinity Empowered
WARNING
To properly use this medical device,
read and comply with these instructions for use.
Anesthesia workstation system
Software 2.n
Page 2
Typographical conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
l
Bullet points indicate individual actions or different options for action.
–
Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
related illustration.
A
Letters in illustrations denote elements referred
to in the text.
>
The "greater than" symbol indicates the navigation path in a dialog window.
Bold italic text is used to identify labeling on the
device and text displayed on the screen.
Screen reproductions
The illustrations of products and screen contents
may, depending on configuration and equipment,
differ from the actual products.
Use of terms
Dräger uses the term "Accessory" not only for accessories in the sense of IEC 60601-1, but also for
consumable parts, removable parts, and attached
parts.
The product "Zeus Infinity Empowered" is also referred to as "Zeus IE".
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Instructions for use Zeus Infinity Empowered SW 2.n
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Trademarks
Trademark
Trademark owner
AutoFlow®
Trademark
Trademark owner
Nellcor®
Zeus®
Covidian
Nellcor OxiMax
Drägersorb®
800 Plus
IVDock™
®
Drägersorb Free
Trident™
Forta®
Dräger Fill™
SpiroLife®
®
Dräger
Dräger
DrägerService®
Bispectral Index™
Aspect Medical Systems
Inc.
VacuSmart®
Saf-T-Fill™
Baxter
Infinity®
Incidin Extra N®
Quik
Fil®
Abbott Laboratories
®
Masimo
Masimo
SET®
BIS™
Buraton 10F
®
Gigasept FF
®
Ecolab
Schülke & Mayr
Masimo Corporation
Signal Extraction
Technology (SET)®
Definition
WARNING
A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
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.
Instructions for use Zeus Infinity Empowered SW 2.n
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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 necessary training and knowledge to use, install, reprocess, maintain, or repair the product.
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.
Service personnel must be trained in the maintenance of medical devices and install, reprocess,
and maintain the product.
Experts
Users
Experts are persons who perform repair or complex
maintenance work on the product.
Users are persons who use the product in accordance with its intended use.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
Abbreviations and Symbols
Explanations are listed in Chapter "Overview" in
sections "Abbreviations" and "Symbols".
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Instructions for use Zeus Infinity Empowered SW 2.n
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Contents
Contents
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
For your safety and that of your patients. . .
9
General safety information . . . . . . . . . . . . . . . . 10
Product-specific safety information. . . . . . . . . . 15
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Data exchange, ports . . . . . . . . . . . . . . . . . . . . 22
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Components . . . . . . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product labels. . . . . . . . . . . . . . . . . . . . . . . . . .
24
33
38
40
Operating concept . . . . . . . . . . . . . . . . . . . . . 41
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen layout . . . . . . . . . . . . . . . . . . . . . . . . . .
Using the touch screen. . . . . . . . . . . . . . . . . . .
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview of the menu structure . . . . . . . . . . . .
42
44
47
48
49
Assembly and preparation . . . . . . . . . . . . . . 57
Before initial use . . . . . . . . . . . . . . . . . . . . . . . .
Zeus IE as a ceiling device. . . . . . . . . . . . . . . .
Establishing the mains power supply . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quik Fil sevoflurane safety filling system . . . . .
Filling system for desflurane. . . . . . . . . . . . . . .
58
59
60
63
65
66
69
72
73
74
77
80
84
87
Instructions for use Zeus Infinity Empowered SW 2.n
Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
89
Device check . . . . . . . . . . . . . . . . . . . . . . . . . .
Switching on Zeus IE. . . . . . . . . . . . . . . . . . . .
Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Automatic self test (Auto self test). . . . . . . . . .
Pretest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Displaying the test results . . . . . . . . . . . . . . . .
Displaying the test results during operation . .
Startup in emergencies . . . . . . . . . . . . . . . . . .
90
94
95
96
99
100
101
104
105
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Start settings . . . . . . . . . . . . . . . . . . . . . . . . . .
Changing patient data . . . . . . . . . . . . . . . . . . .
Integrated SmartPilot View (optional) . . . . . . .
Gas delivery . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Web access (optional) . . . . . . . . . . . . . . . . . . .
IV system – IVenus . . . . . . . . . . . . . . . . . . . . .
End of operation . . . . . . . . . . . . . . . . . . . . . . .
108
112
114
115
122
138
140
156
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
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 . . . . . . . . . . . .
160
160
161
161
162
166
167
168
172
177
179
184
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Overview of the monitoring . . . . . . . . . . . . . . . 188
Device monitoring . . . . . . . . . . . . . . . . . . . . . . 189
Patient monitoring . . . . . . . . . . . . . . . . . . . . . . 197
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Contents
Fault – Cause – Remedy . . . . . . . . . . . . . . . . 249
Technical data . . . . . . . . . . . . . . . . . . . . . . . . 395
Failure behavior . . . . . . . . . . . . . . . . . . . . . . . . 250
Power outage . . . . . . . . . . . . . . . . . . . . . . . . . . 250
Gas failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Ventilator failure . . . . . . . . . . . . . . . . . . . . . . . . 252
Anesthetic gas delivery failure (DIVA failure) . . 252
Mixer and DIVA failure . . . . . . . . . . . . . . . . . . . 252
Rotary safety knob Anesth. Ventilator Off
for ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . 253
In the event of partial system failures . . . . . . . . 253
In the event of device failure . . . . . . . . . . . . . . 254
Failure behavior DPS . . . . . . . . . . . . . . . . . . . . 255
Messages Zeus IE . . . . . . . . . . . . . . . . . . . . . . 255
Metering module faults . . . . . . . . . . . . . . . . . . . 317
General information. . . . . . . . . . . . . . . . . . . . .
Identification . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification . . . . . . . . . . . . . . . . . . . . . . . . . .
Latex-free . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Penetration values of IBF filter . . . . . . . . . . . .
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power supply. . . . . . . . . . . . . . . . . . . . . . . . . .
Ambient conditions . . . . . . . . . . . . . . . . . . . . .
Alarm tone sequence IEC . . . . . . . . . . . . . . . .
Central gas supply. . . . . . . . . . . . . . . . . . . . . .
Gas delivery, control mode FG ctrl. . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . .
General safety standards for anesthesia
workstations . . . . . . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . . .
Essential performance. . . . . . . . . . . . . . . . . . .
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . .
Device combinations . . . . . . . . . . . . . . . . . . . .
Connections to IT networks. . . . . . . . . . . . . . .
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 321
Configuration information . . . . . . . . . . . . . . . . . 322
System setup . . . . . . . . . . . . . . . . . . . . . . . . . . 323
Configuring the screen . . . . . . . . . . . . . . . . . . . 329
Configuring basic settings . . . . . . . . . . . . . . . . 335
Other functions of the system. . . . . . . . . . . . . . 353
Service functions . . . . . . . . . . . . . . . . . . . . . . . 356
Cleaning, disinfection, and sterilization. . . . 357
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 358
Dismantling components . . . . . . . . . . . . . . . . . 360
Reprocessing methods. . . . . . . . . . . . . . . . . . . 367
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 371
Care instructions for monitoring accessories . . 376
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 378
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 383
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 384
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385
Preventive maintenance. . . . . . . . . . . . . . . . . . 387
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
Disposal of the medical device . . . . . . . . . . . . . 392
Disposing of accessories . . . . . . . . . . . . . . . . . 392
Disposal of non-rechargeable batteries . . . . . . 393
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396
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399
400
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404
404
405
407
408
408
409
411
412
413
413
414
416
416
417
418
418
418
420
422
422
423
423
426
426
428
429
430
435
436
Instructions for use Zeus Infinity Empowered SW 2.n
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Contents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 439
Gas flow diagram . . . . . . . . . . . . . . . . . . . . . . . 440
Gas control loops . . . . . . . . . . . . . . . . . . . . . . . 441
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 446
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . . 446
Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 451
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455
Instructions for use Zeus Infinity Empowered SW 2.n
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This page was intentionally left blank.
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Instructions for use Zeus Infinity Empowered SW 2.n
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For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . . 10
Strictly follow these instructions for use . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . .
Metrological checks*. . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Information on electromagnetic compatibility . .
Sterile accessories . . . . . . . . . . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
10
10
10
11
11
12
12
12
12
13
13
14
14
14
Product-specific safety information . . . . . . . 15
Instructions for use Zeus Infinity Empowered SW 2.n
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For your safety and that of your patients
General safety information
The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific
to subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this device.
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.
Strictly follow these instructions for use
WARNING
Risk of incorrect operation and of incorrect
use
If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance".
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 20
and in conjunction with appropriate patient
monitoring (see page 12).
Dräger recommends DrägerService for a service contract and for repairs. Dräger also recommends using original Dräger parts for
maintenance.
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.
Safety checks*
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Metrological checks*
The medical device must undergo regular metrological checks. See chapter "Maintenance".
*
10
Only applies in the Federal Republic of Germany
Instructions for use Zeus Infinity Empowered SW 2.n
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For your safety and that of your patients
Accessories
Connected devices
WARNING
Risk due to incompatible accessories
WARNING
Risk of electric shock and device malfunction
Dräger has tested only the compatibility of accessories listed in the current list of accessories. If other, incompatible accessories are
used, there is a risk of patient injury due to
medical device failure.
Any connected devices or device combinations not complying with the requirements
mentioned in these instructions for use can
compromise the correct functioning of the
medical device and lead to an electric shock.
Before using the medical device, refer to and
strictly comply with the instructions for use of
all connected devices and device combinations.
Dräger recommends that the medical device is
only used together with accessories listed in
the current list of accessories.
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
– Filter
– Endotracheal suction
– Vaporizer
– Manual resuscitator
– AGSS terminal unit
Instructions for use Zeus Infinity Empowered SW 2.n
WARNING
Risk of device malfunction
The medical device may be operated in combination with other Dräger devices or with devices from third party manufacturers. If a device combination is not approved by Dräger,
the safety and the functionality of the individual devices may be compromised.
– The operating organization must ensure
that the device combination complies with
the applicable editions of the relevant
standards for medical devices.
– Strictly observe assembly instructions and
instructions for use for each networked device.
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For your safety and that of your patients
Not for use in areas of explosion hazard
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.% or combustible or explosive gas mixtures are likely to occur.
Safe connection with other electrical
equipment
Patient monitoring
The user of the medical device is responsible for
choosing a suitable patient monitoring system that
provides appropriate information on medical device
performance and patient condition.
Patient safety can be achieved by a wide variety of
means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs.
The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.
CAUTION
Risk of patient injury
Connections to electrical devices not listed in
these instructions for use may only be made when
approved by each respective device manufacturer.
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 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:
–
Dangers that are obvious to the user
–
Consequences of obvious improper use of the
medical device
–
Possible negative impacts on patients with various underlying diseases
Medical device modification or misuse can be dangerous.
12
Instructions for use Zeus Infinity Empowered SW 2.n
Page 13
For your safety and that of your patients
Information on electromagnetic compatibility
WARNING
Risk of electric shock
General information on electromagnetic compatibility (EMC) according to international EMC standard
IEC 60601-1-2:
The connection of devices to auxiliary power
sockets can lead to an increased leakage current. If the protective ground of one of these
devices fails, the leakage current may rise
above the permissible values.
– Only connect with the approval of the respective device manufacturer.
– Have the leakage current checked by service personnel.
– If the permissible value is exceeded, use a
mains power socket on a wall instead of
the auxiliary power socket of the device.
Medical electrical equipment is subject to special
precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and
put into operation in accordance with the provided
EMC information (see page 430).
Portable and mobile radio frequency communication equipment can affect medical electrical equipment.
WARNING
Risk of electric shock
Do not connect connectors with an ESD warning symbol and do not touch their pins without
implementing ESD protective measures. Such
protective measures can include antistatic
clothing and shoes, touching a potential equilization pin 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.
Sterile accessories
CAUTION
Risk of medical device failure and patient injury
Do not use accessories in sterile packaging if the
packaging has been opened, damaged, or if there
are other signs that the accessories are not sterile.
Reuse, reprocessing, and sterilization of disposable products is not permitted.
WARNING
Risk of device failure
Electromagnetic fields can compromise
proper operation of the device. Electromagnetic fields are generated by, e.g., radio frequency communication equipment such as:
– Mobile phones
– Radio frequency electrosurgical equipment
– Defibrillators
– Shortwave therapy equipment
Use radio frequency equipment only with a
sufficient safety clearance of at least 20 cm
(7.9 in).
Instructions for use Zeus Infinity Empowered SW 2.n
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For your safety and that of your patients
Installing accessories
CAUTION
Risk of device failure
Install the accessory on the basic device in accordance with the instructions of the basic device.
Check for secure connection to the basic device.
Strictly observe the instructions for use and assembly instructions.
Storing the instructions for use
CAUTION
Risk of operating errors
Instructions for use must be kept accessible to the
user.
Training
Training for users is available from the Dräger organization responsible, see www.draeger.com.
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Instructions for use Zeus Infinity Empowered SW 2.n
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For your safety and that of your patients
Product-specific safety information
WARNING
Risk of misinterpretation
WARNING
Risk of not hearing the alarm tone
Misdiagnosis or misinterpretation of the
measured values or other parameters may endanger the patient.
Dräger recommends the user to remain in the
vicinity of the anesthesia machine, i.e. within
a distance of up to 4 meters (12 ft). This facilitates fast recognition and response in the
event of an alarm.
Do not make therapeutic decisions based
solely on individual measured values and
monitoring parameters. Therapeutic decisions must be made solely by the user.
WARNING
Risk of malfunction
Unallowed modifications to the medical device lead to malfunctions.
This medical device may not be modified without permission from Dräger.
WARNING
Risk of malfunction
Device failure or user errors may compromise
the correct functioning of the device. The
medical device does not react automatically to
certain changes in the patient condition, operating errors, or failure of components.
WARNING
Risk of insufficient ventilation
Device failure or operating errors can lead to
ventilation failure.
– To ensure immediate remedial action in
case of device failure, the device may only
be operated under permanent supervision
of users.
– The general safety standards for anesthesia systems require that a manual resuscitator be kept at the ready for emergency
ventilation.
WARNING
Risk of burns
Do not use humidifiers or heated hoses!
Continuously monitor the medical device so
that corrective measures can be initiated immediately.
WARNING
Risk of device failures
The device may fail if the power supply is interrupted.
Always connect the device on an uninterruptible power supply.
Instructions for use Zeus Infinity Empowered SW 2.n
15
Page 16
For your safety and that of your patients
WARNING
Risk of fire
WARNING
Risk of burns
The flow sensor may ignite medications or
other substances that are easily flammable.
– 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.
Conductive breathing hoses or face masks
may cause burns during HF surgery.
WARNING
Risk due to flow measurement failure
Deposits which are not removed during reprocessing may damage the measuring wires
in the flow sensor or cause fire.
– Before inserting the flow sensor check for
visible damage, soiling, and particles. Repeat this check regularly.
– Replace flow sensors when damaged,
soiled, or not particlefree.
WARNING
Risk of strangulation
Make connection to the patient carefully.
WARNING
Zeus IE must not be used with magnetic resonance imaging (MRI, NMR, NMI). Device operation may be affected, thus placing the patient
at risk.
WARNING
Device contamination possible
Only operate Zeus IE with airway filters.
16
Do not use this type of hose and mask combined with HF surgery.
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.
WARNING
Risk of patient injury
The following operating states are prohibited
when the patient is connected:
– Standby
– Self test
– Leak test
– Leakage assistant
– Pretest
– Service mode
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!
Instructions for use Zeus Infinity Empowered SW 2.n
Page 17
For your safety and that of your patients
CAUTION
Risk of crushing
CAUTION
Risk of tipping over during transport
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
The medical device may tip over if handled incorrectly. Observe the following points when transporting medical devices:
– The medical device may only be moved by
people who have the physical ability to do so.
– To improve the maneuverability, transport the
device with 2 persons.
– When transporting over inclines, around corners, or over thresholds (e.g., through doors
or in elevators), make sure that the medical
device does not bump against anything.
– Clear the writing tray and fold it down completely or slide it into the device.
– Do not pull the medical device over hoses, cables, or other obstacles lying on the floor.
– Do not activate the brake while the medical
device is being moved.
– Use only the handles provided to push or pull
the device.
CAUTION
Risk of crushing
If the writing tray is not correctly locked in place,
objects can fall down or fingers and breathing
hoses, for example, can be pinched.
Make sure that the writing tray is correctly locked
when folding down or sliding into the device.
CAUTION
Health risk
Operate Zeus IE with connected anesthetic gas
scavenging system (AGSS) only.
CAUTION
Do not use silicone spray! Silicone spray may
cause breathing system valves to stick.
CAUTION
Do not use DIVA metering modules which have
been dropped or damaged. Any damage may result in faulty metering.
Instructions for use Zeus Infinity Empowered SW 2.n
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Page 18
For your safety and that of your patients
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, make sure that the slope of the floor
does not exceed ±10°.
If the transport position is not maintained, the
maximum slope of the floor is reduced to ±5°.
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.
NOTE
Risk of injury
Handle the DIVA metering module with care and
prevent it from tilting and falling down.
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.
18
Instructions for use Zeus Infinity Empowered SW 2.n
Page 19
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . .
Device monitoring. . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring (optional). . . . . . . . . . . . . . .
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas disposal. . . . . . . . . . . . . . . . . . . . . . . . . . .
Breathing system . . . . . . . . . . . . . . . . . . . . . . .
20
20
20
21
21
22
22
22
Data exchange, ports . . . . . . . . . . . . . . . . . . . 22
Instructions for use Zeus Infinity Empowered SW 2.n
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Page 20
Application
Intended use
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.
Ventilation modes
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 nitrous oxide with
pure oxygen and additional delivery of volatile anesthetic agents and/or intravenous drugs.
Volume-controlled ventilation with decelerating inspiratory flow Volume Control AutoFlow;
synchronization of Sync.(VC) and Pressure Support breaths if required.
Application
The Anesthesia workstation system Zeus IE is designed for use in medical rooms, operating rooms
and induction and recovery rooms.
Applications range from adults to pediatric patients
and neonates.
Ventilation is accomplished on the patient through
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.
20
Volume-controlled ventilation at constant inspiration flow Volume Control
Pressure-controlled ventilation Pressure Control;
synchronization of Sync.(PC) and Pressure Support breaths if required.
Pressure-supported ventilation at constant positive
airway pressure Pressure Support
Manual ventilation/spontaneous breathing with and
without CPAP MAN/SPON
Device monitoring
The following are displayed 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
Instructions for use Zeus Infinity Empowered SW 2.n
Page 21
Application
The following are displayed 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.
Patient monitoring (optional)
The following are displayed 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
–
–
–
–
–
Tidal volume, inspiratory VTi
Inspiratory anesthetic gas concentration
Recognition of anesthesia gas mixtures
Inspiratory O2 and N2O concentrations FiO2,
inN2O
Inspiratory and expiratory CO2 concentrations
inCO2, etCO2
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
Applicable intravenous drugs
The following are displayed 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.
All suitable medications permitted for anesthesia
and for metering with syringe pumps (optional).
Applicable gas mixtures for the carrier gas
–
–
O2/Air
O2/N2O
*
depending on the options installed
Monitoring
The monitoring of the patient is ensured by adjustable alarm limits.
Device monitoring
–
–
–
Airway pressure Paw
Expiratory minute volume MVe
Apnea
Instructions for use Zeus Infinity Empowered SW 2.n
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Page 22
Application
Gas supply
Breathing system
The plug formats of the Zeus IE anesthesia workstation are selectable and comply with the customary formats in the particular country.
Interfaces to the patient are the 22 mm ∅-sockets
on the breathing system for the connection of
EN 12342-compliant breathing hoses.
Zeus IE has connections for O2, Air or N2O backup
gas cylinders, which must be equipped with pressure reducers and pressure sensors.
For breathing systems without rebreathing, e.g.,
Bain system, an external fresh-gas outlet is available (optional).
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.
Data exchange, ports
MEDIBUS is a software protocol for data transfer
between Zeus IE and external medical or non-medical devices (e.g., hemodynamic monitors, data
management systems, or computers) via an RS232
interface.
Before transferring data, ensure strict compliance
with the following documents:
–
–
–
MEDIBUS.X, Rules and Standards for Implementation (9052607)
MEDIBUS.X, Profile Definition for Data Communication V1.n (9052608)
MEDIBUS, Supported Data SW 1.n (9040096)
Serial ports
Two serial ports, COM 1 and COM 2, are provided
for data communication using the Dräger MEDIBUS data protocol.
USB interface
The USB ports enable data exchange with Dräger
USB storage media.
Network interface
Zeus IE can be connected to a network using the
following interfaces.
–
Infinity network connection in conjunction with
patient monitoring (optional).
–
Network ports for remote diagnosis, printers,
and web applications, e.g., WebView (optional).
If a corresponding service contract has been
obtained, the function Remote Service can be
executed via a network connection and the hospital network.
For further information on connections to IT networks, see page 436.
The COM 3 serial port can only be used in conjunction with the Integrated SmartPilot View option.
22
Instructions for use Zeus Infinity Empowered SW 2.n
Page 23
Overview
Overview
Components . . . . . . . . . . . . . . . . . . . . . . . . . . 24
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 . . . . . . . . . . . . . . . . . .
24
25
25
26
27
28
29
30
31
32
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 33
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Product labels. . . . . . . . . . . . . . . . . . . . . . . . . 40
Instructions for use Zeus Infinity Empowered SW 2.n
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Page 24
Overview
Components
Front
A
P
O
N
M
L
K
J
I
H
B
C
D
E
001
F
G
A Operating 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 Module DPS (Dynamic Pressure System) syringe pumps, optional
G Drawer
H Endotracheal suction
I
Drägersorb CLIC disposable absorber
(or reusable absorber)
J
Output from O2 flow meter
24
Instructions for use Zeus Infinity Empowered SW 2.n
Page 25
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+
E APL valve
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,
F Self-test adapter
as long as the central O2 supply is connected.
C Safety rotary knob Anesth. Ventilator Off
D Safety rotary knob for O2 emergency delivery
O2
G O2 flow meter for regional anesthesia
H Output from O2 flow meter
I
External fresh-gas outlet (ext. FG outlet), optional
J
Expiratory port
K Breathing bag nozzle
L CO2 absorber
M Protect water trap
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 Inspiratory port
Instructions for use Zeus Infinity Empowered SW 2.n
25