primus_infinity_empowered__instructions_for_use_sw_.pdf
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Instructions for Use
Primus Infinity Empowered
WARNING
To properly use this medical device,
read and comply with these Instructions for Use.
Anesthesia Workstation
SW 4.5n
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.
–
Dashes indicate the listing of data, options, or
objects.
A Letters in illustrations denote elements referred
to in the text.
Any text shown on the screen and any labeling on
the device are printed in bold and italics, e.g. PEEP,
Air, or Alarm Settings.
The "greater than" symbol > indicates the navigation path in a dialog window, e.g. System Setup >
Ventilation > Basic Settings. In this example,
System Setup represents the dialog window title,
Ventilation represents a horizontally aligned tab,
and Basic Settings a vertically aligned tab.
Screen reproductions
The reproductions of screen content in the instructions for use can differ from the content actually
shown on the screen.
Product name
In these Instructions for Use, Primus IE, the abbreviated form of the device name, is used instead of
the long form Primus Infinity Empowered.
Trademarks
Registered trademarks
–
DrägerService®
–
Drägersorb®
–
D-Vapor®
–
Infinity®
–
Spirolog®
–
SpiroLife®
–
Vapor®
–
WaterLock®
is a registered trademark of Chemische Fabrik
DR. WEIGERT GmbH & Co. KG.
Pending trademark applications
VacuSmartTM is a pending trademark application of
Dräger.
are registered trademarks of Dräger.
–
Durasensor®
–
OxiMax®
are registered trademarks of Nellcor.
–
2
Neodisher® Medizym
Instructions for Use Primus Infinity Empowered SW 4.5n
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Safety information definitions
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.
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
For explanations refer to sections Abbreviations
and Symbols see page 29.
Instructions for Use Primus Infinity Empowered SW 4.5n
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Instructions for Use Primus Infinity Empowered SW 4.5n
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Components . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ancillary functions. . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
28
29
31
Operating concept . . . . . . . . . . . . . . . . . . . . . 35
Screen ergonomics. . . . . . . . . . . . . . . . . . . . . .
Keys with permanent functions (hard keys) . . .
Keys with variable functions (soft keys) . . . . . .
Selecting and setting . . . . . . . . . . . . . . . . . . . .
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . .
System LED indicators . . . . . . . . . . . . . . . . . . .
General information about Infinity ID
functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Menu Structure Overview . . . . . . . . . . . . . . . . .
36
37
38
38
41
42
43
45
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Before first use . . . . . . . . . . . . . . . . . . . . . . . . .
Information about transport within the clinic . . .
Accessory Weight Limits . . . . . . . . . . . . . . . . .
Primus Infinity Empowered as a wall/ceiling
device (optional) . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the gas supply . . . . . . . . . . . . . . . .
Connecting the anesthetic gas scavenging
system AGS . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the endotracheal aspiration
system (optional) . . . . . . . . . . . . . . . . . . . . . . .
Connecting the patient system . . . . . . . . . . . . .
Connecting the flexible arm for the manual
breathing bag (optional) . . . . . . . . . . . . . . . . . .
Park holder for vaporizer units (optional) . . . . .
Connecting the electrical connections . . . . . . .
52
53
54
55
58
60
61
62
66
67
68
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 71
Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Instructions for Use Primus Infinity Empowered SW 4.5n
Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emergency start . . . . . . . . . . . . . . . . . . . . . . .
81
86
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
89
Starting Operation . . . . . . . . . . . . . . . . . . . . . .
Setting fresh-gas concentrations. . . . . . . . . . .
Setting the Vapor . . . . . . . . . . . . . . . . . . . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Using non-rebreathing systems. . . . . . . . . . . .
Changing patients . . . . . . . . . . . . . . . . . . . . . .
90
93
95
96
112
113
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Alarm displays . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm priorities and alarm signals . . . . . . . . . .
Suppressing alarms. . . . . . . . . . . . . . . . . . . . .
Limit-based alarms activated in respective
ventilation modes . . . . . . . . . . . . . . . . . . . . . .
Enabling/disabling CO2 alarms . . . . . . . . . . . .
HLM mode. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enabling/disabling SpO2 alarms (optional) . . .
Displaying and setting alarm limits . . . . . . . . .
120
121
122
124
125
126
128
129
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Selecting the standard screen . . . . . . . . . . . . .
Monitoring mode . . . . . . . . . . . . . . . . . . . . . . .
Screen layout . . . . . . . . . . . . . . . . . . . . . . . . .
Displayed parameters . . . . . . . . . . . . . . . . . . .
Gas measurement. . . . . . . . . . . . . . . . . . . . . .
Using the volumeter function. . . . . . . . . . . . . .
Econometer (optional) . . . . . . . . . . . . . . . . . . .
Loops (optional). . . . . . . . . . . . . . . . . . . . . . . .
Mini trends (optional). . . . . . . . . . . . . . . . . . . .
Selecting the data screen . . . . . . . . . . . . . . . .
Selecting the trend screen. . . . . . . . . . . . . . . .
Selecting the logbook . . . . . . . . . . . . . . . . . . .
Using the timer function. . . . . . . . . . . . . . . . . .
SpO2 measurement (optional). . . . . . . . . . . . .
134
135
135
136
138
141
142
142
143
145
145
147
148
149
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 153
Configuring the default settings. . . . . . . . . . . .
Basic settings and audible signals . . . . . . . . .
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interfaces/logbook . . . . . . . . . . . . . . . . . . . . . .
154
155
156
157
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Contents
Screen layout . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Setting alarm limits . . . . . . . . . . . . . . . . . . . . . . 159
Ventilator and gas delivery . . . . . . . . . . . . . . . . 161
System information. . . . . . . . . . . . . . . . . . . . . . 164
Configuration during operation . . . . . . . . . . . . . 166
Setting the patient's age and weight during
operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Fault – Cause – Remedy . . . . . . . . . . . . . . . . 171
Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Gas failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Ventilator failure . . . . . . . . . . . . . . . . . . . . . . . . 174
Fresh gas delivery failure . . . . . . . . . . . . . . . . . 175
Ventilator and fresh gas delivery failure . . . . . . 175
Gas measurement failure . . . . . . . . . . . . . . . . . 176
Screen error . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
User interface failure . . . . . . . . . . . . . . . . . . . . 176
System failure. . . . . . . . . . . . . . . . . . . . . . . . . . 177
Alarm messages. . . . . . . . . . . . . . . . . . . . . . . . 178
Cleaning, Disinfection and Sterilization . . . . 197
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Reprocessing Procedure . . . . . . . . . . . . . . . . . 205
Reprocessing List. . . . . . . . . . . . . . . . . . . . . . . 208
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Preventive maintenance. . . . . . . . . . . . . . . . . . 219
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Emptying or replacing the water trap . . . . . . . . 222
Replacing the O2 sensor . . . . . . . . . . . . . . . . . 223
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Disposal of the Medical Device . . . . . . . . . . . . 226
Disposal of Non-Rechargeable Batteries . . . . . 226
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 227
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . 228
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 247
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
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Instructions for Use Primus Infinity Empowered SW 4.5n
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safe networking of computers . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Information on Electromagnetic
Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sterile accessories . . . . . . . . . . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Only one copy of the Instructions for Use
available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emission of Radio Frequency Energy . . . . . . .
8
8
8
8
9
9
9
9
9
10
10
10
11
11
11
Product-specific safety information . . . . . . . 11
Functional safety . . . . . . . . . . . . . . . . . . . . . . . 13
Instructions for Use Primus Infinity Empowered SW 4.5n
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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 medical
device.
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 17). 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
The medical device must be inspected and
serviced regularly by professionals who possess the required qualifications due to their
training and their experience.
Repair of the medical device must also be performed by trained personnel with additional
product-specific DrägerService training.
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService.
Dräger further recommends that only authentic Dräger repair parts are used for maintenance.
If the above are not complied with, the correct
functioning of the medical device may be
compromised.
See chapter "Maintenance".
Accessories
WARNING
Only the accessories indicated on the list of
accessories 90 39 430 (1st edition or higher)
have been tested and approved for use with
the medical device.
Therefore, it is strongly recommended that
only these accessories are used in conjunction with the medical device. Otherwise, the
correct functioning of the medical device may
be compromised.
Not for use in areas of explosion hazard
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
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Instructions for Use Primus Infinity Empowered SW 4.5n
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For Your Safety and that of your Patients
Connected devices
WARNING
Risk of electric shock and of device malfunction
Any connected devices or device combinations not complying with the requirements
mentioned in these Instructions for Use may
compromise the correct functioning of the
medical device. Before operating any combination of devices, refer to and strictly comply
with the Instructions for Use for all connected
devices and device combinations.
–
EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
–
EN 60601-1-4 (IEC 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Follow Assembly Instructions and Instructions for
Use.
Patient safety
Safe connection with other electrical
equipment
WARNING
Risk of electric shock
Electrical connections to equipment not listed
in these Instructions for Use must only be
made when approved by each respective manufacturer.
Safe networking of computers
When networking with electrical devices, the operator is responsible for ensuring that the resulting
system meets the requirements set forth by the following standards:
–
–
EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
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 professionals, 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 professionals 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.
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 patient´s condition.
Instructions for Use Primus Infinity Empowered SW 4.5n
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For Your Safety and that of your Patients
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 selection 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 international EMC standard
IEC60601-1-2:
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 EMC
information provided on page 247.
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING
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 personnel must be instructed in these
ESD protective measures.
WARNING
Risk of electric shock
Connecting devices to the auxiliary outlets of the anesthesia
machine can cause an increase
in leakage current beyond permissible values if the protective conductor of
a device fails.
Check the leakage current when connecting
devices to the auxiliary outlets. If connecting
a device (or devices) increases the leakage
current to a value which exceeds the permissible value, do not use the auxiliary outlets of
the anesthesia machine: use a separate wall
socket.
The system must meet the requirements for
medical electrical equipment in accordance to
IEC/EN 60601-1-1 and IEC/EN 60601-1-2.
Sterile accessories
CAUTION
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged or there
are other signs of non-sterility. Disposable articles
must not be reprocessed and resterilized. Reuse,
reprocessing, or resterilization can lead to a failure of the medical device and cause injury to the
patient.
Installing accessories
CAUTION
Install accessories to the basic device in accordance with the Instructions for Use of the basic
device. Make sure that there is a safe connection
to the basic device system.
Strictly observe Assembly Instructions and Instructions for Use.
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Instructions for Use Primus Infinity Empowered SW 4.5n
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For Your Safety and that of your Patients
Only one copy of the Instructions for Use
available
CAUTION
The medical devices are not available individually.
Only one copy of the Instructions for Use is
included in the clinical package and must therefore be kept in a location accessible for users.
Training
Training for users is available from the Dräger organization responsible, see www.draeger.com.
Emission of Radio Frequency Energy
For wireless communication with Infinity ID accessories, this medical device is equipped with an
RFID (Radio Frequency Identification) system.
Any changes or modifications to the RFID system
must be implemented by properly trained service
personnel; otherwise patient safety may be negatively affected.
This medical device was developed and produced
in such a manner that the emission limits for radio
frequency (RF) energy will not be exceeded. These
limits are part of international safety standards,
such as IEC 60601-1-2 (EN 60601-1-2), and have
been defined by regulatory bodies such as the Federal Communications Commission (FCC Rules),
Industry Canada (Radio Standards Specifications)
and the European Telecommunications Standards
Institute (ETSI Standards).
The RFID system of this medical device complies
with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may
not cause harmful interference, and (2) this device
must accept any interference received, including
interference that may cause undesired operation.
Product-specific safety information
WARNING
Risk due to barely audible alarms
WARNING
Risk due to a noisy environment
The user must remain within the hearing
range of the acoustic alarm signal. This permits quick recognition and handling of the
alarm.
When operating in a noisy environment, the
volume of the alarm signals must be adjusted
to suit.
Adjust the volume of the alarm signal to the
distance from the medical device.
Instructions for Use Primus Infinity Empowered SW 4.5n
Always set the volume of the alarm signal sufficiently high.
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For Your Safety and that of your Patients
WARNING
Risk of use error
CAUTION
Risk of patient injury
Various potentially dangerous situations may
occur which demand the attention of trained
personnel.
An incorrect diagnosis or misinterpretation of
measured values, or other parameters, may
endanger the patient.
The workstation may only be used under the
permanent supervision of qualified medical
personnel so that assistance can be provided
immediately in the event of any malfunctions.
Do not base therapy decisions on individual measured values or monitoring parameters only.
WARNING
Risk of fire
In order to prevent a fire hazard, explosive
anesthetics, such as ether or cyclopropane,
must not be used.
WARNING
Risk of device failure and/or danger to patient
Magnetic fields may negatively influence the
proper function of the anesthesia machine,
thus endangering the patient.
Primus IE must not be used with magnetic resonance imaging (MRT, NMR, NMI)!
WARNING
Risk of explosion, fire
If an oxygen leak is suspected within or near
the anesthesia machine, do not initiate operation.
Disconnect all oxygen supplies and contact a
trained service technician.
WARNING
Risk of fire
WARNING
Risk of patient injury
If ventilation of the patient is no longer
assured due to an obvious fault in the equipment, the patient must immediately be ventilated with a separate emergency ventilator.
Always keep a manual ventilator at hand.
WARNING
Risk of burns
Conductive breathing hoses or face masks
may cause burns during HF surgery.
Do not use these types of hoses and masks in
combination with HF surgery.
CAUTION
Risk of mechanical failure
The shock and vibrations caused by transportation may lead to a mechanical failure. The application of a wall or ceiling mount is designated for
buildings.
Do not use the anesthesia machine for mobile
facilities such as ambulances, helicopters or
ships.
To prevent a fire hazard, drugs or other substances based on inflammable solvents, such
as alcohol, must not be introduced into the
patient system.
Adequate ventilation must be ensured if
highly inflammable substances are used for
disinfection.
12
Instructions for Use Primus Infinity Empowered SW 4.5n
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For Your Safety and that of your Patients
CAUTION
Risk of physical injury
To avoid physical injury, e.g. pinching, pay special
attention to edges, moving parts and corners
when working with drawers, the ventilator module,
doors, the writing tray and/or swivel arms for
mounted devices, as well as other accessories,
such as gas cylinders, vaporizer units, CLIC
absorbers and CLIC adapters.
CAUTION
Risk of device failure
Compressed gas supply (central supply or cylinder): To avoid damaging the device(s) attached to
a gas supply, use only medical gases. Pay particular attention to national and international standards regulating the use of medical gases.
Functional safety
The essential performance features comprise:
–
Delivery of medical gases enriched with anesthetic agents in adjustable concentrations and
amounts
–
Patient ventilation with parameters and modes
set by the user
–
Monitoring functions and alarm functions with
settings selected by the user:
–
minimum minute volume
–
maximum airway pressure
–
minimum and maximum O2 and anesthetic
gas concentration in the breathing gas
The medical device is equipped with basic safety
features to reduce the likelihood of patient injury
until the cause of an alarm is remedied.
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Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Utilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . .
The following measured values are
displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters can be displayed
as mini trends . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters are displayed as
curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following are displayed as bar graphs . . . .
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16
16
16
17
17
17
17
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Application
Intended use
WARNING
Risk of device failure and/ or danger to patient
If the intended use of this anesthesia machine
is not adhered to, it may fail and/or the patient
may be endangered.
–
Spontaneous breathing (Spont.)
–
Pressure-assisted spontaneous breathing in
Press. Support CPAP (optional)
–
Volume AF (Volume Mode AutoFlow)
(optional).
With activation of: Synchronization,
Press. Support (Pressure support) (optional)
Use the anesthesia machine only as specified
in the intended use of these Instructions for
Use.
Primus Infinity Empowered – Anesthesia Workstation for adults, children, and neonates with automatic and manual ventilation, as well as
spontaneous breathing with or without pressure
support.
The following measured values are
displayed
–
Peak pressure PEAK, mean pressure PMEAN,
plateau pressure PLAT, and PEEP
–
Expiratory minute volume MV,
difference between insp. and exp. minute volume MVLEAK,
–
patient compliance CPAT,
Utilization
–
Inhalation anesthesia in rebreathing systems
–
Inhalation anesthesia in semi-closed to virtually
closed systems with "low flow" and "minimal
flow" techniques (for minimal gas and anesthetic agent consumption)
–
Inhalation anesthesia in non-rebreathing systems, with a separate fresh-gas outlet for connecting, e.g. a Bain system or Magill system,
with a fresh-gas flow of 0.2 to 18 L/min
(optional).
tidal volume VT,
breathing rate freq.
–
Inspiratory and expiratory concentration of O2,
N2O, anesthetic gas, and CO2
–
ΔO2:
difference between insp. and exp. O2 concentration
Optional:
Ventilation modes
–
–
Functional oxygen saturation (SpO2) and pulse
rate
Volume-controlled ventilation in Volume Mode.
With activation of: Synchronization,
Press. Support (Pressure support) (optional)
–
Pressure-controlled ventilation in
Pressure Mode.
With activation of: Synchronization,
Press. Support (Pressure support) (optional)
–
16
Manual ventilation (Man.)
Instructions for Use Primus Infinity Empowered SW 4.5n
Page 17
Application
The following parameters can be
displayed as mini trends*
–
CO2 minute volume MV*CO2
–
O2 Uptake
–
PEEP, patient compliance CPAT
The following parameters are displayed
as curves
Monitoring
by means of adjustable alarm limits which can automatically be adapted to the momentary ventilation
situation.
With monitoring for
–
Airway pressure PAW
–
Expiratory minute volume MV
–
Apnea
–
Inspiratory and expiratory anesthetic gas concentration
–
Airway pressure PAW
–
Inspiratory and expiratory flow
–
–
Inspiratory and expiratory concentration of O2,
CO2, and anesthetic gas
Detection of anesthetic gas mixtures (simultaneous detection of up to two anesthetic agents)
–
Inspiratory O2 and N2O concentrations
Optional:
–
Inspiratory and expiratory CO2 concentrations
–
Plethysmogram
–
Special alarm response in HLM mode
–
PAW-V loops and V-Flow loops
–
Automatic agent alarm activation for multiples
of MAC (xMAC)
The following are displayed as bar
graphs
–
Inspiratory, expiratory, and leakage tidal volume
–
Volumeter
–
Pressure
–
Econometer for indicating fresh-gas utilization
(optional)
Optional:
–
Oxygen saturation
–
Pulse rate
Trends showing the measured values over time
and a logbook are also available.
*
optional
Instructions for Use Primus Infinity Empowered SW 4.5n
17
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18
Instructions for Use Primus Infinity Empowered SW 4.5n
Page 19
Overview
Overview
Components . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas inlets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen with user interface . . . . . . . . . . . . . . . .
Interface panel . . . . . . . . . . . . . . . . . . . . . . . . .
Flexible arm for manual breathing bag
(optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Auxiliary flowmeter and mechanical
pressure gauge (optional). . . . . . . . . . . . . . . . .
Gas flow diagram . . . . . . . . . . . . . . . . . . . . . . .
20
21
22
23
24
25
26
27
Ancillary functions . . . . . . . . . . . . . . . . . . . . . 28
Infinity ID wireless accessory detection
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
MEDIBUS/MEDIBUS.X Protocol . . . . . . . . . . . 28
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 29
List of abbreviations used in the software
and on the device . . . . . . . . . . . . . . . . . . . . . . . 29
List of general abbreviations. . . . . . . . . . . . . . . 30
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Instructions for Use Primus Infinity Empowered SW 4.5n
19
Page 20
Overview
Components
Front
V
A
B
C
U
T
S
R
Q
D
E
F
G
H
I
J
P
K
L
M
N
001
O
A
B
C
D
E
F
G
H
I
J
K
20
Lighting control (dimmer)
Top shelf (for external monitors)
Screen with user interface
Rotary knob
System power switch
O2 emergency delivery Safety O2
O2 flush button O2+
Writing table
Breathing system
Release button for ventilator module
Disposable absorber Drägersorb CLIC
(or reusable absorber)
L
M
N
O
P
Q
R
S
T
U
V
Drawer
Central brake
Footrest
Castors
Endotracheal aspiration system (optional)
Water trap with sample line connection
Auxiliary oxygen flowmeter (optional)
Mechanical pressure gauge (optional)
Vapor units with Interlock system
External fresh-gas outlet (optional)
Auxiliary AC socket (for Desflurane vaporizer)
Instructions for Use Primus Infinity Empowered SW 4.5n
Page 21
Overview
Rear
M
L
A
B
C
K
J
002
I
D
E
F
G
H
A Connectors for reserve gas cylinder pressure
sensors
B O2 sensor
(not applicable for consumption-free O2 measurement)
C Filter for fan
D Auxiliary outlets
E Type plate
F Pins for grounding cables of auxiliary units
G Scavenging nozzle
H Anesthetic gas scavenging system AGS
I Power cord
J Pin for grounding cable
K Gas inlets
Instructions for Use Primus Infinity Empowered SW 4.5n
L Connection for optional halogen lamp
(Remove cap before use.)
Use the lamp specified in the list of accessories
only!
M Interface panel
21
Typenschild (type plate) wo??? Noch anziehen...
Page 22
Overview
Gas inlets
G
A
F
B
D
C
003
E
A
B
C
D
E
Connection for central gas supply O2
Connection for O2 cylinder
O2 outlet for oxygen flow tube (optional)
Connection for central gas supply AIR
AIR outlet for endotracheal aspiration system
(optional)
F Connection for N2O cylinder
G Connection for central gas supply N2O
22
Instructions for Use Primus Infinity Empowered SW 4.5n
Page 23
Overview
Screen with user interface
A
B
C
D
E
Volume
F
G
U
H
T
S
I
R
J
Q
P
K
N
M
L
300
O
A Status field for the current ventilation mode
B Alarm field for alarms and their class
C Curve field for curves and other displayed modules
D Numerical field for measured values
E Soft keys for monitoring functions
F LEDs indicating the alarm status
G Key for silencing acoustic alarms for 2 minutes
H Key for changing the screen pages
I Key for calling up the standard screen
J Soft keys for ventilation settings
K Rotary knob: "select, set, confirm"
L Key for switching over to Standby
M LEDs for power supply/battery power
N Keys for selecting the ventilation mode
Instructions for Use Primus Infinity Empowered SW 4.5n
O LED indicators for the central gas supply and
reserve gas cylinders
P Keys for selecting the carrier gas (N2O or Air)
Q Soft keys for fresh-gas delivery settings
R Prompt field for user guidance
S Bar graph for gas delivery (virtual flow tubes)
T Bar graph for fresh-gas utilization (econometer)
(optional)
U Parameter field for gas monitoring
23
Page 24
Overview
Interface panel
D
A
C
004
B
A
SpO2
Socket for SpO2 sensor
B
COM 1
MEDIBUS, MEDIBUS.X interface
C
COM 2
MEDIBUS, MEDIBUS.X interface
D
IV System
Connection for Dräger IV System
24
(optional)
Instructions for Use Primus Infinity Empowered SW 4.5n
Page 25
Overview
Flexible arm for manual breathing bag
(optional)
A
005
C B
A Flexible arm
B Knurled screws (for mounting on the breathing
system)
C Cone for Y-piece (for self test)
Instructions for Use Primus Infinity Empowered SW 4.5n
25