primus___instructions_for_use_sw_4-n.pdf
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Instructions for Use
Primus
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
SW 4.n
Page 2
Working with these Instructions for Use
The title of the main chapter in the header line
helps with orientation and navigation.
Typing conventions
The instructions for the user combine text and
illustrations, providing a comprehensive overview
of the system. The information is presented as
sequential steps of action, allowing the user to learn
directly how to use the device.
–
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 sign > is used in menu sequences. First the
main menu is indicated, then the menu option to
be selected and further submenus (if applicable), e.g. System Setup > Ventilation > Basic
Settings.
The text provides explanations and instructs the
user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow
sequence.
1
Consecutive numbers indicate steps of action,
with the numbering restarting with “1” for each
new sequence of actions.
Trademarks
Registered trademarks
–
DrägerService®
–
Drägersorb®
–
D-Vapor®
(A) Letters in parentheses refer to elements in the
relevant illustration.
–
Spirolog®
–
SpiroLife®
The illustrations establish the relationship
between the text and the device. Elements mentioned in the text are highlighted. Unnecessary
details are omitted.
–
Vapor®
–
WaterLock®
Schematic renderings of screen images guide the
user and allow to reconfirm actions performed. The
actual screen images differ in look or in configuration.
–
Durasensor®
–
OxiMax®
A Letters denote elements referred to in the text.
–
z Bullet points indicate individual actions or different options for action.
–
Dashes indicate the listing of data, options, or
objects.
are registered trademarks of Dräger.
are registered trademarks of Nellcor.
Neodisher® Medizym
is a registered trademark of Chemische Fabrik
DR. WEIGERT GmbH & Co. KG.
Pending trademark applications
VacuSmartTM is a pending trademark application of
Dräger.
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Instructions for Use Primus SW 4.n
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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.
Abbreviations and Symbols
Please refer to "Abbreviations" on page 26 and
"Symbols" on page 29 for explanations.
Instructions for Use Primus SW 4.n
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Instructions for Use Primus SW 4.n
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Contents
Contents
For Your Safety and that of your Patients . .
7
General WARNINGS and CAUTIONS . . . . . . .
9
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Starting Operation . . . . . . . . . . . . . . . . . . . . . .
Setting fresh-gas concentrations. . . . . . . . . . .
Setting the Vapor . . . . . . . . . . . . . . . . . . . . . . .
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Using non-rebreathing systems. . . . . . . . . . . .
Changing patients . . . . . . . . . . . . . . . . . . . . . .
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Components . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ancillary functions. . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . .
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
18
25
26
29
Operating concept . . . . . . . . . . . . . . . . . . . . . 31
Screen ergonomics. . . . . . . . . . . . . . . . . . . . . .
Keys with permanent functions (hard keys) . . .
Keys with variable functions (soft keys) . . . . . .
Selecting and setting . . . . . . . . . . . . . . . . . . . .
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . .
System LED indicators . . . . . . . . . . . . . . . . . . .
Menu Structure Overview . . . . . . . . . . . . . . . . .
32
33
34
34
37
38
39
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Before first use . . . . . . . . . . . . . . . . . . . . . . . . .
Information about transport within the clinic . . .
Accessory Weight Limits . . . . . . . . . . . . . . . . .
Primus 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 . . . . . . .
46
47
48
49
51
53
54
55
110
111
112
113
115
116
117
118
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Selecting the standard screen . . . . . . . . . . . . .
Monitoring mode . . . . . . . . . . . . . . . . . . . . . . .
Screen layout . . . . . . . . . . . . . . . . . . . . . . . . .
Displayed parameters . . . . . . . . . . . . . . . . . . .
Gas measurement. . . . . . . . . . . . . . . . . . . . . .
Using the volumeter function. . . . . . . . . . . . . .
Econometer (optional) . . . . . . . . . . . . . . . . . . .
Loops (optional). . . . . . . . . . . . . . . . . . . . . . . .
Selecting the data screen . . . . . . . . . . . . . . . .
Selecting the trend screen. . . . . . . . . . . . . . . .
Selecting the logbook . . . . . . . . . . . . . . . . . . .
Using the timer function. . . . . . . . . . . . . . . . . .
SpO2 measurement (optional). . . . . . . . . . . . .
122
123
123
124
125
128
129
130
131
132
133
134
135
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 139
59
59
60
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 63
Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Self test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Emergency start . . . . . . . . . . . . . . . . . . . . . . . . 77
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Instructions for Use Primus SW 4.n
80
81
83
84
101
102
Configuring the default settings. . . . . . . . . . . .
Basic settings and audible signals . . . . . . . . .
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interfaces/logbook . . . . . . . . . . . . . . . . . . . . . .
Screen layout . . . . . . . . . . . . . . . . . . . . . . . . .
Setting alarm limits . . . . . . . . . . . . . . . . . . . . .
Ventilator and gas delivery . . . . . . . . . . . . . . .
System information . . . . . . . . . . . . . . . . . . . . .
Configuration during operation . . . . . . . . . . . .
140
141
142
143
144
145
147
149
151
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Contents
Setting the patient's age and weight during
operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Fault – Cause – Remedy . . . . . . . . . . . . . . . . 155
Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Gas failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Ventilator failure . . . . . . . . . . . . . . . . . . . . . . . . 158
Fresh gas delivery failure . . . . . . . . . . . . . . . . . 159
Ventilator and fresh gas delivery failure . . . . . . 159
Gas measurement failure . . . . . . . . . . . . . . . . . 160
Screen error . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
System failure. . . . . . . . . . . . . . . . . . . . . . . . . . 161
Alarm messages. . . . . . . . . . . . . . . . . . . . . . . . 162
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Removing components. . . . . . . . . . . . . . . . . . . 180
Scope of validity . . . . . . . . . . . . . . . . . . . . . . . . 187
Sequence of steps . . . . . . . . . . . . . . . . . . . . . . 187
What is meant by hygiene and care? . . . . . . . . 187
Disinfecting/cleaning/sterilizing . . . . . . . . . . . . 188
Care list Primus anesthesia workstation. . . . . . 190
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Emptying or replacing the water trap . . . . . . . . 203
Replacing the O2 sensor . . . . . . . . . . . . . . . . . 205
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Disposing of batteries and O2 sensors . . . . . . . 208
Disposing and emptying of water trap . . . . . . . 208
Disposing of the used device . . . . . . . . . . . . . . 208
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 209
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . 210
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 227
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
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Instructions for Use Primus SW 4.n
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For Your Safety and that of your Patients
For Your Safety and that of your Patients
Strictly follow these Instructions for Use . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safe networking of computers . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
8
8
8
8
8
9
9
9
General WARNINGS and CAUTIONS . . . . . .
9
Note on EMC/ESD risk for the device
function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Accessories in sterile packaging . . . . . . . . . . . 11
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Instructions for Use Primus SW 4.n
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Page 8
For Your Safety and that of your Patients
Strictly follow these Instructions for Use
WARNING
Strictly follow these Instructions for Use.
Any use of the medical device requires full
understanding and strict observation of all
portions of these instructions. The medical
device is only to be used for the purpose
specified under "Intended use" on page 14
and in conjunction with appropriate patient
monitoring (see page 15). 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 service personnel.
Repair of the medical device may also only be
carried out by trained service personnel.
Dräger Medical recommends that a service
contract be obtained with DrägerService and
that all repairs also be carried out by them.
Dräger Medical recommends that only authentic Dräger Medical repair parts be used for
maintenance. Otherwise the correct functioning of the medical device may be compromised.
See chapter "Maintenance".
Accessories
WARNING
Only the accessories indicated on the list of
accessories 86 03 522 (13th edition or higher)
have been tested and approved for use with
the medical device. Accordingly it is strongly
recommended that only these accessories be
used in conjunction with the specific 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.
Safe connection with other electrical
equipment
WARNING
Risk of electric shock.
Electrical connections to equipment not listed
in these Instructions for Use should only be
made following consultation with the respective manufacturers of the equipment involved.
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.
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Instructions for Use Primus SW 4.n
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For Your Safety and that of your Patients
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
–
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
The design of the medical device, the accompanying literature, and the labeling on the medical
device take into consideration that the purchase
and use of the medical device are restricted to
trained professionals, and that certain inherent
characteristics of the medical device are known to
the trained operator. Instructions, warnings, and
caution statements are limited, therefore, largely to
the specifics of the Dräger design.
This publication excludes references to various
hazards which are obvious to a medical professional and operator of this medical device, to the
consequences of medical device misuse, and to
potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous.
Patient monitoring
The operators of the medical device must recognize their responsibility for choosing appropriate
safety monitoring that supplies adequate information on medical device performance and patient
condition.
Patient safety may be achieved through a wide
variety of different means ranging from electronic
surveillance of medical device performance and
patient condition to simple, direct observation of
clinical signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical
device operator.
Dräger Medical GmbH
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to
general operation of the device. WARNINGS and
CAUTIONS specific to subsystems or particular
features appear with those topics in later sections
of these Instructions for Use or in the devicespecific Instructions for Use.
Instructions for Use Primus SW 4.n
9
Page 10
For Your Safety and that of your Patients
WARNING
Risk of use error.
Various potentially dangerous situations may
occur which demand the attention of trained
personnel.
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.
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 must not be used with magnetic resonance imaging (MRT, NMR, NMI)!
WARNING
Risk of fire.
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.
Note on EMC/ESD risk for the device
function
Electromedical devices are subject to special precautionary measures concerning electromagnetic
compatibility (EMC) and must be installed and put
into operation in accordance with the EMC information included, see page 227.
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING
Connector pins with an ESD
warning sign should not be
touched and no connections
should be made between these
connectors without implementing ESD protective measures. Such precautionary procedures may
include antistatic clothing and shoes, the
touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves. All staff involved
in the above shall receive instruction in these
ESD precautionary procedures.
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.
General information on electromagnetic compatibility (EMC) pursuant to international EMC standard
IEC60601-1-2: 2001
10
Instructions for Use Primus SW 4.n
Page 11
For Your Safety and that of your Patients
Accessories in sterile packaging
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.
Reprocessing and resterilization of single-use
accessories is not permitted.
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.
Software
CAUTION
Risk of mechanical failure.
The device's software has been developed and
tested carefully in accordance with Dräger's high
quality standards. It is therefore highly improbable
that software errors can become a hazard to the
patient.
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.
Additionally, independent protective functions are
extensively implemented in the software, as well as
in electronics and mechanics, for all safety-related
functions of the device. Through this, the probability
that an error in the software or other functions can
be detected before it affects the patient's safety is
very high. Regular automated or manual tests
ensure the effectiveness of all protective measures.
CAUTION
Risk of physical injury.
CAUTION
Risk of patient injury.
An incorrect diagnosis or misinterpretation of
measured values, or other parameters, may
endanger the patient.
Do not base therapy decisions on individual measured values or monitoring parameters only.
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.
Instructions for Use Primus SW 4.n
Do not use the anesthesia machine for mobile
facilities such as ambulances, helicopters or
ships.
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.
Dräger Medical cannot be held liable for any damage which occurs as a result of these instructions
not being observed.
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Instructions for Use Primus SW 4.n
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Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Utilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . .
The following measured values are
displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following parameters are displayed as
curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The following are displayed as bar graphs . . . .
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instructions for Use Primus SW 4.n
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14
14
15
15
15
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Page 14
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,
Use the anesthesia machine only as specified
in the intended use of these Instructions for
Use.
Press. Support (Pressure support) (optional)
Primus – 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
Utilization
–
Expiratory minute volume MV,
difference between insp. and exp. minute volume MVLEAK,
patient compliance CPAT,
–
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).
–
Inspiratory and expiratory concentration of O2,
N2O, anesthetic gas, and CO2
–
ΔO2:
–
Ventilation modes
tidal volume VT,
breathing rate freq.
difference between insp. and exp. O2 concentration
Optional:
–
–
Volume-controlled ventilation in Volume Mode.
Functional oxygen saturation (SpO2) and pulse
rate
With activation of: Synchronization,
Press. Support (Pressure support) (optional)
–
Pressure-controlled ventilation in
Pressure Mode.
With activation of: Synchronization,
Press. Support (Pressure support) (optional)
–
14
Manual ventilation (Man.)
Instructions for Use Primus SW 4.n
Page 15
Application
The following parameters are displayed
as curves
–
Airway pressure PAW
–
Inspiratory and expiratory flow
–
Inspiratory and expiratory concentration of O2,
CO2, and anesthetic gas
–
Special alarm response in HLM mode
–
Automatic agent alarm activation for multiples
of MAC (xMAC)
Optional:
–
Oxygen saturation
–
Pulse rate
Optional:
–
Plethysmogram
–
PAW-V loops and V-Flow loops
The following are displayed as bar
graphs
–
Inspiratory, expiratory, and leakage tidal volume
–
Volumeter
–
Pressure
–
Econometer for indicating fresh-gas utilization
(optional)
Trends showing the measured values over time
and a logbook are also available.
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
–
Detection of anesthetic gas mixtures (simultaneous detection of up to two anesthetic agents)
–
Inspiratory O2 and N2O concentrations
–
Inspiratory and expiratory CO2 concentrations
Instructions for Use Primus SW 4.n
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Instructions for Use Primus SW 4.n
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Overview
Overview
Components . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas inlets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen with user interface . . . . . . . . . . . . . . . .
Interface panel . . . . . . . . . . . . . . . . . . . . . . . . .
Flexible arm for manual breathing bag
(optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas flow diagram . . . . . . . . . . . . . . . . . . . . . . .
18
19
20
21
22
23
24
Ancillary functions . . . . . . . . . . . . . . . . . . . . . 25
MEDIBUS Protocol . . . . . . . . . . . . . . . . . . . . . . 25
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 26
List of abbreviations used in the software
and on the device . . . . . . . . . . . . . . . . . . . . . . . 26
List of general abbreviations. . . . . . . . . . . . . . . 28
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Instructions for Use Primus SW 4.n
17
Page 18
Overview
Components
Front
P
A
O
N
B
C
D
E
F
G
H
M
L
I
J
001
K
A
B
C
D
E
F
G
H
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*
*
available since November 2004
18
I
J
K
L
M
N
O
P
Absorber
(optional disposable Dräger absorber
Drägersorb CLIC)
Drawer
Castors with locking brake
Endotracheal aspiration system (optional)
Water trap with sample line connection
Vapor units with Interlock system
External fresh-gas outlet (optional)
Top shelf (for external monitors)
Instructions for Use Primus SW 4.n
Page 19
Overview
Rear
L
A
B
C
K
J
D
E
F
G
I
002
H
A Connectors for reserve gas cylinder pressure
sensors
B O2 sensor
(not applicable for consumption-free O2 measurement)
C Filter for fan
D Pins for grounding cables of auxiliary units
E Auxiliary outlets with fuse switches
F Scavenging nozzle
G Anesthetic gas scavenging system AGS
H Power cord
I Pin for grounding cable
J Gas inlets
K Connection for optional halogen lamp
(remove cap before use.)
Use the lamp specified in the list of accessories
only!
Instructions for Use Primus SW 4.n
L Interface panel
19
Page 20
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
20
Instructions for Use Primus SW 4.n
Page 21
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 SW 4.n
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
21
Page 22
Overview
Interface panel
(Available since January 2005, interfaces which are not used
were removed.)
D
A
C
004
B
A
SpO2
Socket for SpO2 sensor
B
COM 1
MEDIBUS interface
C
COM 2
MEDIBUS interface
D
IV System
Connection for Dräger IV System
22
(optional)
Instructions for Use Primus SW 4.n
Page 23
Overview
Flexible arm for manual breathing bag
(optional)
A
B
005
C
A Flexible arm
B Knurled screws (for mounting on the breathing
system)
C Cone for Y-piece (for self test)
Instructions for Use Primus SW 4.n
23
Page 24
Overview
Gas flow diagram
J
I
A
MAN
C
N 2O
Air
O2
N
MAN
SPONT
H
Q
P
R
0
Vol %
Isoflurane
Dräger
O
L
K
G
P
M
AUTO
Vapor 2000
0.5 L
P
P
E
S
D
T
M
O2+
F
U
100
B
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
24
N2O cylinder
O2 cylinder
Gas inlet valves
Safety oxygen control
Flow control
O2 flush
Breathing bag
Vaporizer
APL valve
to scavenger
Absorber
Exp. valve
PEEP/PMAX
Sample line
PAW sensor
Exp. flow sensor
Gas measurement
Insp. valve
Insp. flow sensor
Piston pump ventilator
Ext. fresh-gas outlet (optional)
Instructions for Use Primus SW 4.n
Page 25
Overview
Ancillary functions
MEDIBUS Protocol
MEDIBUS is a software protocol for use in transferring data between Primus and an external medical
or non-medical device (e.g. hemodynamic monitors, data management systems, or a Windowsbased computer) via the RS-232 interface (see
9037426, sixth edition or higher).
WARNING
Risk of patient injury.
Data transferred via the MEDIBUS interface is
for information only and is not intended as a
basis for diagnosis or therapy decisions.
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.
Instructions for Use Primus SW 4.n
25