fabius_plus_instructions_for_use_sw_3-n.pdf
Page 1
Instructions for Use
Fabius plus
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
Software 3.n
Page 2
Working with these
Instructions for Use
The configuration functions available in Standby
include calibrations, system tests, and the management of default settings.
To access Standby mode:
1
Press the »
« key (Standby).
566
1
The waveform window is replaced by a confirmation message and the instruction to shut off flow.
The LED on the Standby key starts blinking and will
remain blinking until Standby is confirmed.
NOTE:
If confirmation does not occur within 15 seconds,
the ventilator remains in the previous mode and the
waveform window is restored.
z Confirm the mode change. The ventilator enters
Standby mode, the Standby screen replaces the
previous screen, and the Standby LED stops
blinking and remains on.
The following soft key labels appear at the bottom of the Standby screen:
– »Run System Test«
– »Calibrate Flow Sensor«
– »Calibrate O2 Sensor«
– »Leak/Compl Test«
– »Access Alarm Log«
– »Restore Site Defaults«
z Turn off fresh gas flow.
112
Instructions for Use Fabius plus SW 3.n
305
Left-Hand Column – the Text
The text in the left-hand column provides explanations and step-by-step instructions on the practical
use of the machine.
z Bullet points indicate separate actions.
1 Where several actions are described, numbers
are used to refer to relevant details in the illustrations. On each page the numbering restart
with “1”.
– Dashes indicate the listing of data, options or
objects.
Configuration Functions in Standby
Mode
522
Page Body
The page body in these Instructions for Use combines text and illustrations. The information is presented as sequential steps of action, giving the user
hands-on experience in learning how to use the
Fabius plus machine.
Configuration
501
Header Line
The header line on each page contains the title of
the chapter.
Right-Hand Column – the Illustrations
The illustrations provide visual reference for the
text and for locating the various parts of the equipment. Elements mentioned in the text are highlighted. Renderings of screen displays guide the user
and provide a way to reconfirm actions performed.
Typing Conventions in this Manual
– User controls, such as hard keys and soft keys,
and screen pages are printed in bold within quotation marks, e.g., »PEEP« or »Volume Settings«
– Screen messages are printed in bold within
quotation marks, e.g., »Flow Calibration in
progress«
– Alarm messages are printed in bold within quotation marks, including the exclamation marks
that indicate their alarm urgency level, e.g.,
»APNEA PRESSURE!!!«
2
Instructions for Use Fabius plus SW 3.n
Page 3
Trademarks
®
Definition of the Target Group
®
®
DrägerService , Spirolog , SpiroLife ,
Drägersorb®, D-Vapor®, Fabius® plus, Vapor®, and
Vitalink® are registered trademarks of Dräger.
Selectatec® is a registered trademark of
Datex-Ohmeda.
All other products or brand names are trademarks
of their respective owners.
Definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
The following group of users is defined with respect
to the use of the medical device:
Professionals
These users are persons
– who have been instructed on the medical
device, and
– who are medical professionals, or have received technical training, and
– who are authorized to use and reprocess or to
instal and maintain the medical device in accordance with the intended use.
Dräger recommends that the medical device is
used exclusively by professionals.
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 equipment or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Abbreviations and Symbols
Please refer to "Abbreviations" on page 30 and
"Symbols" on page 31 for explanations.
Notice
This document is provided for customer information
only, and will not be updated or exchanged without
customer request.
Depending on the configuration of the individual
medical device, the images in the Instructions for
Use may differ.
Instructions for Use Fabius plus SW 3.n
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This page intentionally left blank
4
Instructions for Use Fabius plus SW 3.n
Page 5
Contents
Contents
Working with these Instructions for Use . . . . . 2
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Abbreviations and Symbols . . . . . . . . . . . . . . . . . 3
Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Definition of the Target Group. . . . . . . . . . . . . . . . 3
For Your Safety and that of Your Patients . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
System Overview . . . . . . . . . . . . . . . . . . . . . . . 15
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Compact Breathing System (Top View) . . . . . . . 17
Rear View (Pin-Index Connector). . . . . . . . . . . . 18
Threaded Connectors. . . . . . . . . . . . . . . . . . . . . 19
Interface Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . . . . 21
Vaporizer Exclusion Systems . . . . . . . . . . . . . . . 21
Fabius plus as a Wall Device . . . . . . . . . . . . . . . 23
Auxiliary Oxygen Flow Meter . . . . . . . . . . . . . . . 24
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Communication Ports . . . . . . . . . . . . . . . . . . . . . 26
Auxiliary Fresh-Gas Outlet . . . . . . . . . . . . . . . . . 27
Accessory Weight Limits . . . . . . . . . . . . . . . . . . 29
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Operation Concept . . . . . . . . . . . . . . . . . . . . . . 33
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
The Screen Display . . . . . . . . . . . . . . . . . . . . . . 35
Rotary Knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Fixed Function Keys . . . . . . . . . . . . . . . . . . . . . . 36
Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Fresh-Gas Control . . . . . . . . . . . . . . . . . . . . . . . 41
LED Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Gas System Color Coding . . . . . . . . . . . . . . . . . 42
Screen Color Concept . . . . . . . . . . . . . . . . . . . . 42
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Activating the Battery . . . . . . . . . . . . . . . . . . . . . 44
Fitting the CO2 Absorber on the Compact
Breathing System . . . . . . . . . . . . . . . . . . . . . . . . 44
Instructions for Use Fabius plus SW 3.n
Installing the Drägersorb CLIC Absorber . . . . . 45
Connecting the Compact Breathing System . . . 46
Inserting the Flow Sensor . . . . . . . . . . . . . . . . . 47
Connecting the Waste-Gas Outlet Port . . . . . . . 48
Installing the Flexible Bag Arm or Breathing
Bag Extension*and Bag . . . . . . . . . . . . . . . . . . 48
Connecting Pipeline Supply of N2O, AIR and
O2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Connecting the Reserve Gas Cylinders (for PinIndex Mounting). . . . . . . . . . . . . . . . . . . . . . . . . 50
Connecting the Reserve Gas Cylinders for
N2O, AIR and O2 (for Cylinders with Threaded
Connectors). . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Connecting the AGS Anesthetic Gas
Receiving System . . . . . . . . . . . . . . . . . . . . . . . 55
Connecting the Suction System . . . . . . . . . . . . 57
Connecting the Breathing Hoses. . . . . . . . . . . . 58
Inserting a new O2 Sensor Capsule . . . . . . . . . 60
Connecting the O2 Sensor . . . . . . . . . . . . . . . . 60
Connecting the Pressure Sensor . . . . . . . . . . . 61
Connecting the Pressure Breathing Gauge. . . . 61
Connecting the Flow Sensor . . . . . . . . . . . . . . . 62
Connecting the APL Bypass and PEEP/PMAX
Hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Attaching the Manual Ventilation Bag . . . . . . . . 63
Preparing the Ventilator . . . . . . . . . . . . . . . . . . . 63
Ventilator Safety Features . . . . . . . . . . . . . . . . . 63
Installing Vaporizers . . . . . . . . . . . . . . . . . . . . . 64
Additional Equipment . . . . . . . . . . . . . . . . . . . . 64
Potential Equalization . . . . . . . . . . . . . . . . . . . . 65
Connecting AC Power . . . . . . . . . . . . . . . . . . . . 65
Auxiliary power outlets . . . . . . . . . . . . . . . . . . . 66
Daily and Pre-use Checkout . . . . . . . . . . . . . . . 66
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . 67
Powering-Up the Machine . . . . . . . . . . . . . . . . . 68
Power-Up Standby Screen . . . . . . . . . . . . . . . . 69
Checking Readiness for Operation . . . . . . . . . . 69
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Power-Up Standby Screen . . . . . . . . . . . . . . . .
Setting Fresh-Gas Flow. . . . . . . . . . . . . . . . . . .
Setting Vaporizer Concentration . . . . . . . . . . . .
O2 Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low Flow Anesthesia . . . . . . . . . . . . . . . . . . . .
72
72
74
75
76
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Page 6
Contents
Nitrogen Wash-Out (If Required) . . . . . . . . . . . . 76
Replacing CO2 Absorbent . . . . . . . . . . . . . . . . . 76
Ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Ventilator Safety Features . . . . . . . . . . . . . . . . . 95
Changing Patients . . . . . . . . . . . . . . . . . . . . . . . 96
Ending Operation . . . . . . . . . . . . . . . . . . . . . . . . 97
Using the external fresh-gas outlet as a
common gas outlet . . . . . . . . . . . . . . . . . . . . . . . 98
Using the external fresh-gas outlet with an
additional switch . . . . . . . . . . . . . . . . . . . . . . . . 101
Preparing for Storage or Transport. . . . . . . . . . 104
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Oxygen Monitoring . . . . . . . . . . . . . . . . . . . . . . 112
O2 Monitoring Disabled . . . . . . . . . . . . . . . . . . 116
O2 Low Supply Alarm . . . . . . . . . . . . . . . . . . . . 116
Respiratory Volume Monitoring . . . . . . . . . . . . 117
Breathing Pressure Monitoring. . . . . . . . . . . . . 119
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 121
Configuration Functions in Standby Mode . . . . 122
Configuration during Operation . . . . . . . . . . . . 143
Fault-Cause-Remedy . . . . . . . . . . . . . . . . . . . 151
Power Failure Backup . . . . . . . . . . . . . . . . . . . 152
Ventilator Fail State . . . . . . . . . . . . . . . . . . . . . 154
Overriding the Ventilator. . . . . . . . . . . . . . . . . . 154
Fault-Cause-Remedy . . . . . . . . . . . . . . . . . . . . 156
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . 181
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Routine Maintenance . . . . . . . . . . . . . . . . . . . 185
Checking Readiness for Operation . . . . . . . . . 187
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Disposal of the Medical Device . . . . . . . . . . . . 190
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 191
Ambient Conditions . . . . . . . . . . . . . . . . . . . . .
Machine Data . . . . . . . . . . . . . . . . . . . . . . . . .
Fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EMC declaration . . . . . . . . . . . . . . . . . . . . . . .
Electrical Safety Conformance . . . . . . . . . . . .
General Safety Standards for Anesthesia . . . .
Freedom from latex . . . . . . . . . . . . . . . . . . . . .
Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anesthesia Gas Supply Module . . . . . . . . . . .
Anesthetic Agent Vaporizer Interface . . . . . . .
Breathing System . . . . . . . . . . . . . . . . . . . . . .
Low Oxygen Supply Pressure Alarm. . . . . . . .
S-ORC (Sensitive Oxygen Ratio Controller) . .
Serial Interface . . . . . . . . . . . . . . . . . . . . . . . .
Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
192
192
194
195
200
200
200
200
203
204
206
208
208
209
210
Appendix – Daily and Pre-use Checkout
Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Safety information on reprocessing . . . . . . . . . 164
Pre-cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Reprocessing methods. . . . . . . . . . . . . . . . . . . 164
Removing the Compact Breathing System. . . . 167
Dismantling Parts of the Ventilator . . . . . . . . . . 169
Removing anesthetic gas scavenging system
(AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Removing the Suction System . . . . . . . . . . . . . 170
Reprocessing Breathing system. . . . . . . . . . . . 170
Care List for Fabius plus Components . . . . . . . 172
Reassembling the Breathing System . . . . . . . . 174
Reinstalling the Ventilator . . . . . . . . . . . . . . . . . 176
Reinstalling the Scavenger System . . . . . . . . . 177
Reinstalling the Suction System . . . . . . . . . . . . 179
Checking Readiness for Operation . . . . . . . . . 180
6
Instructions for Use Fabius plus SW 3.n
Page 7
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use . . . . . . 8
Not for use in areas of explosion hazard . . . . . . 8
Safe connection with other electrical
equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safe networking of computers . . . . . . . . . . . . . . 8
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring . . . . . . . . . . . . . . . . . . . . . . . 9
General WARNINGS and CAUTIONS . . . . . . 10
Note on EMC/ESD risk for the device function 10
Accessories in sterile packaging . . . . . . . . . . . 10
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Instructions for Use Fabius plus SW 3.n
7
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 9). Strictly observe all WARNING and CAUTION statements throughout
these Instructions for Use and all statements
on medical device labels.
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by trained service personnel.
Repair of the medical device may also only be
carried out by trained service personnel.
Dräger recommends that a service contract be
obtained with DrägerService and that all
repairs also be carried out by them. Dräger
recommends that only authentic Dräger repair
parts be used for maintenance. 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 9052267 (1. edition or higher)
have been tested and approved to be used
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.
8
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
Electrical connections to equipment which is
not listed in these Instructions for Use should
only be made following consultation with the
respective manufacturers.
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.
Instructions for Use Fabius plus SW 3.n
Page 9
For Your Safety and that of Your Patients
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.
Instructions for Use Fabius plus SW 3.n
9
Page 10
For Your Safety and that of Your Patients
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 the manual.
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibility (EMC) pursuant to international EMC standard
IEC 60601-1-2: 2001
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 195.
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.
10
WARNING
Risk of electric shock
Connecting devices to the
Medical Power Outlet Strip 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 Medical
Power Outlet Strip. 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
Fabius plus: use a separate wall socket.
The system must meet the requirements for
medical equipment in accordance with
IEC/EN 60601-1-1 and IEC/EN 60601-1-2 and
the particular standards of the connected
devices.
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.
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.
Instructions for Use Fabius plus SW 3.n
Page 11
For Your Safety and that of Your Patients
Software
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.
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.
WARNING
Do not use conductive breathing hoses or
face masks.
They may cause burns during HF surgery.
WARNING
Any person involved with the setup, operation, or maintenance of the Fabius plus anesthesia workstation must be thoroughly
familiar with this instruction manual.
WARNING
This anesthesia workstation will not respond
automatically to certain changes in patient
condition, operator error, or failure of components. The anesthesia workstation has to be
operated under the constant supervision and
control of a qualified operator in order to provide immediate corrective action.
WARNING
No third-party components shall be attached
to the anesthesia workstation, ventilator, or
breathing system (except for certain approved
components), otherwise the correct functioning of the medical device may be compromised. For more information, contact
DrägerService or your local authorized service organization.
Instructions for Use Fabius plus SW 3.n
WARNING
Each institution and user has a duty to independently assess, based on its, his, or her unique circumstances, what components to
include in an anesthesia workstation. However, Dräger, in the interest of patient safety,
strongly recommends the use of an oxygen
analyzer, pressure monitor, volume monitor,
and end-tidal CO2 monitor in the breathing circuit at all times.
WARNING
Risk of unintentional movement of the anesthesia workstation
Apply the caster brakes when the anesthesia
workstation is in use.
WARNING
Remove any equipment mounted on the
machine before transport. The writing table
should also be free of all objects and pushed
back in the locked position.
If these precautions are not followed, the
device may tip over and pose a risk to safety.
WARNING
Risk of fire
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.
WARNING
Explosive anesthetics, such as ether or cyclopropane, must not be used due to the risk of
fire.
WARNING
Always keep a breathing bag at hand. If ventilation of the patient is compromised, the patient must be immediately ventilated with a
separate emergency ventilator.
11
Page 12
For Your Safety and that of Your Patients
WARNING
Do not apply unregulated suction to the patient circuit when using the device.
WARNING
To avoid electrical shock hazard: Due to the
risk of electrical shock, do not remove any
component cover. Refer any servicing to
DrägerService. Use only hospital-grade
grounded electric outlets and power cord.
This device is to be used only in rooms with
line power installations complying with national safety standards for hospital patient
rooms (e.g. IEC 60601-1 "Safety of Medical
Electrical Equipment"). Make sure the external
equipment is hospital-grade (regarding national regulations) grounded before connecting
the equipment. Disconnect the power supply
from the electrical outlet before cleaning or
servicing. Let it dry completely before reconnecting it to the electrical outlet. Always
ensure that the clamp for the power cord at the
power supply end is tight, thus preventing an
accidental disconnect from the unit. Do not
connect additional external equipment other
than equipment specified by Dräger.
CAUTION
Communications with external equipment may be
temporarily affected by electromagnetic interference due to the use of electrosurgical equipment.
CAUTION
Do not use Fabius plus during magnetic resonance (MRI, NMR, NMI).
Device operation may be affected, thus placing
the patient at risk.
12
CAUTION
Risk of physical injury
To avoid physical injury, pay special attention to
edges, moving parts and corners when working
with:
– drawers,
– the ventilator module,
– the writing tray,
– swivel arms for mounted devices,
– gas cylinders,
– vaporizer units,
– CLIC absorbers and CLIC adapters,
as well as other accessories.
CAUTION
Risk of pinching fingers or breathing hoses and
objects falling down
If the writing table is not engaged correctly,
objects can fall down and fingers or breathing
hoses can be pinched.
CAUTION
Risk of device failure
If the anesthesia workstation is operated when tilted, components maybe damaged or may function improperly.
Do not operate the anesthesia workstation if it is
tilted more than 1°.
NOTE
Software must be installed by qualified personnel.
We recommend to contact DrägerService for software installation.
NOTE
If the error-free state of the protective earthing conductor or its connection to the device is doubtful,
the device must be operated using the internal
power supply (battery).
Instructions for Use Fabius plus SW 3.n
Page 13
Intended Use
Intended Use
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . 14
MEDIBUS and Vitalink Protocols . . . . . . . . . . . 14
Instructions for Use Fabius plus SW 3.n
13
Page 14
Intended Use
Intended Use
Fabius plus is an inhalation anesthesia workstation
for use in operating, induction and recovery rooms.
It may be used with O2, N2O, and AIR supplied by
a medical gas pipeline system or by externally
mounted gas cylinders.
Fabius plus is equipped with a compact breathing
system, providing fresh-gas decoupling, PEEP, and
pressure limitation.
The following ventilation options are available:
–
–
–
–
–
–
Volume Controlled Ventilation
Pressure Controlled Ventilation (Optional)
Pressure Support (Optional)
SIMV/PS (Optional)
Manual Ventilation
Spontaneous Breathing
Fabius plus is equipped with an electrically driven
and electronically controlled ventilator and monitors
for airway pressure (P), volume (V), and inspiratory
oxygen concentration (FiO2).
As per IEC 60601-2-13 (Anesthetic Workstations
and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and
anesthetic agent is required when the machine is in
use.
NOTE
"O2 Monitoring Disabled" is a local authorized service organization-configurable option. See "O2
Monitoring Disabled" on page 116 for more information. In this case, external FiO2 monitoring must
be available.
14
IEC 60601-2-13 :2003 requires that a manual ventilation bag must be available for emergency use.
Fresh-gas enrichment is provided by the Dräger
Vapor anesthetic vaporizer.
MEDIBUS and Vitalink Protocols
MEDIBUS and Vitalink are software protocols for
use in transferring data between the Fabius plus
and an external medical or non-medical device
(e.g., hemodynamic monitors, data management
systems, or a Windows-based computer) via the
RS-232 interface (see 9038530, 3rd edition or higher).
WARNING
Data transferred via MEDIBUS and Vitalink
interfaces are for information only and are not
intended as a basis for diagnosis or therapy
decisions.
WARNING
In order to protect patients and users from
electrical hazards, is it imperative that all systems consisting of electrical medical devices
and other electrical devices, such as but not
limited to PCs, printers, etc., be mounted
exclusively by trained personnel.
The system must meet the requirements about
medical electrical equipment in accordance to
IEC/EN 60601-1-1 and IEC/EN 60601-1-2.
Instructions for Use Fabius plus SW 3.n
Page 15
System Overview
System Overview
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Compact Breathing System (Top View) . . . . 17
Rear View (Pin-Index Connector) . . . . . . . . . 18
Threaded Connectors . . . . . . . . . . . . . . . . . . 19
Interface Panel . . . . . . . . . . . . . . . . . . . . . . . . 20
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . 21
Vaporizer Exclusion Systems . . . . . . . . . . . . 21
Dräger Vapor Interlock 2 System (Optional) . . 21
Selectatec (Optional) . . . . . . . . . . . . . . . . . . . . 22
Dräger Auto Exclusion 2 Vaporizer Mount (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Fabius plus as a Wall Device . . . . . . . . . . . . 23
Auxiliary Oxygen Flow Meter . . . . . . . . . . . . 24
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Communication Ports . . . . . . . . . . . . . . . . . . 26
Recommended Device Configuration . . . . . . . 26
Auxiliary Fresh-Gas Outlet . . . . . . . . . . . . . . 27
Using the external fresh-gas outlet as a
common gas outlet . . . . . . . . . . . . . . . . . . . . . 28
Using the external fresh-gas outlet with an
additional switch . . . . . . . . . . . . . . . . . . . . . . . 28
Accessory Weight Limits . . . . . . . . . . . . . . . 29
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 30
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Instructions for Use Fabius plus SW 3.n
15
Page 16
System Overview
Front View
1
2
plus
15
3
4
O2
14
13
12
5
6
7
11
10
8
073
9
1
2
3
4
5
6
7
Ventilator control panel (settings for ventilation
parameters and airway monitoring)
Display screen
Gauges for Pin index O2 and N2O cylinders*
Gauges for central gas supplier
Flow meters tube block
Fresh-gas control valves
Writing table
*
optional
16
8
9
10
11
12
13
14
15
Storage drawers
Brake
Absorber
Compact Breathing System (COSY)
Ventilator
Auxiliary oxygen flowmeter*
Vapor mount
Oxygen Flush
Instructions for Use Fabius plus SW 3.n
Page 17
System Overview
Compact Breathing System (Top View)
1
2
3
4 5
14
6
13
12
7
8
10
9
064
11
1
2
3
4
5
14
Auxiliary fresh-gas outlet*
PEEP/PMAX valve connection port
Bag holder
Expiratory valve
Flow-sensor guard (flow-sensor protection) or
COSY shielding (not pictured)
Expiratory port
Connector for breathing bag
Inspiratory port
Inspiratory valve
Fresh-gas decoupling valve
APL bypass valve connection port
Breathing system mount with locking bolt
Selecting knob for »MAN« and »SPONT« on
pressure limiting (APL) valve
Sample gas return port
*
optional
6
7
8
9
10
11
12
13
Instructions for Use Fabius plus SW 3.n
NOTE
Graphic depicted without COSY shielding.
17
Page 18
System Overview
Rear View (Pin-Index Connector)
1
2
4
5
066
3
1
2
3
4
5
Connector for cylinders (threaded connectors)*
Connectors for medical gas pipeline supply
(central supply)
Pin index connector for O2*
Pin index connector for N2O or AIR*
Compact Breathing System (COSY)
*
optional
18
Instructions for Use Fabius plus SW 3.n
Page 19
System Overview
Threaded Connectors
1
2
065
3
1
3
Connector for medical gas pipeline supply
(central supply)
Connector for cylinders O2, O2 and N2O or O2
and AIR (threaded connectors)*
Cylinders
*
optional
2
Instructions for Use Fabius plus SW 3.n
19
Page 20
System Overview
Interface Panel
1
10
9
074
8
2
3
4
5
6
7
1
2
3
4
5
6
7
8
9
10
20
Potential equalization pin
COM 1
PEEP
APL
Oxygen Sensor
Pressure Breathing
Volume Sensor
Power cable connection
ON/OFF switch
Fuse
Instructions for Use Fabius plus SW 3.n
Page 21
System Overview
Vaporizers (Optional)
The Dräger Vapor anesthetic agent vaporizers are
used to enrich the fresh gas with a precisely metered quantity of vapor from the liquid anesthetic
agent being used, i.e., Isoflurane, Halothane, Enflurane, Sevoflurane, or Desflurane.
When using a Desflurane vaporizer, it must be connected to mains power.
For complete information, consult the appropriate
Instruction for Use provided with the vaporizer.
Vaporizer Exclusion Systems
The exclusion systems available for the
Fabius plus are described below.
Dräger Vapor Interlock 2 System (Optional)
The Dräger Interlock 2 system is used to ensure
that only one of two vaporizers can be used at a
time. It has a selector lever used to select which
vaporizer is enabled.
070
Moving the selector lever away from the desired
vaporizer allows that vaporizer to be used and the
other to be locked out of use.
075
Note that the selector lever is shown in the center
position. This ensures that both vaporizers are in
the locked position. Also, this is the recommended
position for the selector lever when moving the
Fabius plus.
Instructions for Use Fabius plus SW 3.n
21
Page 22
System Overview
Selectatec (Optional)
The interlock system for the Selectatec is built into
the vaporizers. When a vaporizer is selected for
use, the interlocking index pins will protrude from
the sides of the vaporizer thereby not allowing the
adjacent vaporizer to be opened. For more specific
information on the Selectatec, refer to the
Selectatec Vaporizer’s instruction manual.
Dräger Auto Exclusion 2 Vaporizer Mount (Optional)
This system has an automatic interlock system that
ensures only one vaporizer can be used at a time.
When one of the two vaporizers is selected for use
(opened), the interlock mechanism within that
vaporizer’s mounting system is activated automatically, preventing the other vaporizer from being
used.
NOTE
Only Dräger vaporizers labeled as
"AUTO EXCLUSION" vaporizers are compatible
with the Dräger Auto Exclusion 2-Vaporizer Mount.
See table for the Auto Exclusion Vaporizer technical data.
Normal
Operating
Range
Extended
Operating
Range
≤10 L/min Dräger Vapor 2000
Instruction for Use
Manual’s delivered
concentration accuracy values apply.
>10 to
Dräger auto exclusion
≤15 L/min vaporizer concentration
output accuracy may
be reduced.
When using a Desflurane vaporizer, it must be connected to mains power.
22
Instructions for Use Fabius plus SW 3.n
Page 23
System Overview
Fabius plus as a Wall Device*
The Fabius plus may also be mounted on the wall.
Follow the Assembly Instructions for Fabius plus as
a wall device (9037202, 7th edition or higher).
Fabius plus uses a holder instead of a trolley, see
page 16, to be attached to the wall.
020
NOTE
Do not overload the wall mount. Refer to the
Instructions for Use of the wall mount for the possible load of the wallmount.
*
optional
Instructions for Use Fabius plus SW 3.n
23
Page 24
System Overview
Auxiliary Oxygen Flow Meter*
The auxiliary oxygen flow meter delivers a metered
flow of pure oxygen, used, for example in the
delivery of oxygen through a nasal cannula.
Auxiliary oxygen can be used in any ventilation
mode, in standby, or even if the machine is
switched off.
O2
The auxiliary oxygen flowmeter may be used to
provide supplemental inspired oxygen to a patient
under spinal, epidural, or other regional anesthesia.
It may also be used to enrich the inspired gas
mixture provided by a manually powered selfinflating resusciator bag**.
z Test the auxiliary oxygen flowmeter. Adjust the
flow knob (1) and make sure the float moves
freely over the full range of the flowmeter.
1
077
WARNING
Risk of patient injury
Do not connect the patient directly to the auxiliary oxygen outlet.
High pressure will be applied and the patient
endangered.
WARNING
Risk of fire
Cauterizing close to a source of oxygen can
lead to fire.
When finishing oxygen therapy, make sure the flow
meter is completely closed:
z Turn the flow knob (1) clockwise until it can no
longer be turned.
Only then the oxygen flow is completely off.
WARNING
Risk of fire
Before cauterizing, close the flow meter,
remove the mask and wait a few moments to
ensure that any oxygen accumulation has dissipated.
*
**
24
optional
ASTM F1850-22(2005) §76
Instructions for Use Fabius plus SW 3.n
Page 25
System Overview
APL Valve
WARNING
Risk of patient injury
Route all lines/cables away from the APL
valve to prevent interference with the APL
valve adjustment knob. Lines/cables caught
underneath the APL valve adjustment knob
could interfere with proper functioning of this
valve.
The APL valve has two functions. It limits the maximum pressure during manual ventilation. It also
exhausts excess gas into the scavenger system
during manual and spontaneous ventilation.
The APL valve is connected to the patient airway
through the ventilator. It functions only when the
ventilator is in ManSpont mode or ventilator override condition.
033
The APL valve has a labeled knob for selecting between spontaneous and manual modes of ventilation and for indicating approximate pressure
settings.
– When the APL valve knob is rotated fully counterclockwise, pressure is released for spontaneous ventilation. Spontaneous ventilation
automatically eliminates resistance to patient
exhalation.
– In manual mode, the APL valve knob can be
rotated to change the pressure threshold at
which gas will flow through the valve and into
the scavenging system. Clockwise rotation of
the APL valve knob increases the pressure
threshold, and counterclockwise rotation of the
APL valve knob decreases the pressure threshold. Lifting the top of the APL valve knob will
temporarily relieve pressure.
NOTE
The APL valve is automatically excluded from the
breathing circuit whenever an automatic ventilation mode is selected.
NOTE
Even in automatic ventilation, the APL valve must
be adjusted to a pressure that is safe for the patient!
Instructions for Use Fabius plus SW 3.n
25