fabuis_mri_instruction_for_use_sw_3-n_edition_9_jan.pdf
Page 1
Instructions for Use
Fabius MRI
WARNING
To properly use this medical device,
read and comply with these Instructions for Use.
Anesthesia Workstation
Software 3.n
Page 2
Working with These
Instructions for Use
Header Line
The header line on each page contains the title of
the chapter.
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 MRI workstation.
Configuration
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.
z 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.
Configuration Functions in Standby
Mode
The configuration functions available in Standby
include calibrations, system tests, and the management of default settings.
To access Standby mode:
1
Press the »Standby« key.
566
1
522
NOTE:
If confirmation does not occur within 15 seconds,
the ventilator remains in the previous mode and the
waveform window is restored.
501
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«
124
Instructions for Use Fabius MRI SW 3.n
305
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 MRI SW 3.n
Page 3
Trademarks
®
Definition of target groups
®
®
DrägerService , Spirolog , SpiroLife ,
Drägersorb®, Fabius® MRI, Vapor®, and Vitalink®
are registered trademarks of Dräger Medical.
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.
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
For this medical device users, service personnel,
and experts are defined as target groups.
These traget groups have been instructed in the
use of the medical device and have the necessary
knowledge to use, install, reprocess, maintain or
repair the medical device.
Dräger emphasizes that the medical device must
be used, installed, reprocessed, maintained or
repaired exclusively by defined target groups.
Users
Users are persons who may use the medical device
in accordance with its intended use.
Service personnel
Service personnel are persons who are responsible
for the maintenance of the medical device towards
the operating organization.
Service personnel are persons who may instal,
reprocess, or maintain the medical device.
Experts
Experts are persons who may carry out repair or
complex maintenance work on the medical device.
Please refer to “Abbreviations” on page 34 and
“Symbol Definition” on page 35 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 MRI SW 3.n
3
Page 4
Magnetic Resonance (MR) Definitions
Term
Meaning
MR
Magnetic Resonance
MRI
Magnetic Resonance Imaging
MRT
Magnetic Resonance Tomography
MR Safe
An item that poses no known hazards in all MR environments.
MR Environment
This term is used to describe the general environment present in
the vicinity of an MRT scanner. In particular, this refers to the
area within the 5-gauss line around the scanner. Characteristics
of the environment include the following:
1) the static magnetic field (the range of 0.2 to 3 tesla is most
common, but it can exceed 4.0 tesla*) and associated spatial
gradients;
2) rapidly changing magnetic fields (imaging gradients ~kHz);
and
3) radio frequency (RF) magnetic field pulses (on the order of
tens to hundreds of MHz, i.e., in the FM radio band).
The "MR Environment" includes anywhere in the MR procedure
room, including the center of the bore of the MRT scanner.
*1 tesla = 10000 gauss
Five-Gauss Line
This line specifies the perimeter around an MRT scanner within
which the static magnetic fields are higher than five gauss. Five
gauss and below are considered "safe” levels of static magnetic
field exposure for the general public. (5 gauss = 0.50 mtesla)
Image Artifact
This is a general term that refers to an inappropriate image
signal at a specified spatial location. lt is generally characterized
as increased signal intensity in an area which is known to
contain no signal producing material or decreased signal
intensity (voids) where signal should be produced.
MR Conditional
An item that has been demonstrated to pose no known hazards
in a specified MR enviroment with specified conditions of use.
Field conditions that define the specified MR enviroment include
field strength, spatial gradient, dB/dt (time rate of change of the
magnetic field), radio frequency (RF) fields and specific
absorption rate (SAR).
4
Instructions for Use Fabius MRI 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 target groups . . . . . . . . . . . . . . . . . . 3
Magnetic Resonance (MR) Definitions . . . . . . . . . 4
For Your Safety and that of Your Patients . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . 16
System Overview . . . . . . . . . . . . . . . . . . . . . . . 17
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Compact Breathing System (Top View) . . . . . . . 19
Rear View (Threaded Connectors) . . . . . . . . . . 20
Interface Panel . . . . . . . . . . . . . . . . . . . . . . . . . 21
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . . . . 22
Vaporizer Exclusion Systems . . . . . . . . . . . . . . . 22
Auxiliary Oxygen Flowmeter. . . . . . . . . . . . . . . . 24
O2 Flush Button . . . . . . . . . . . . . . . . . . . . . . . . . 25
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Writing Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Communication Port . . . . . . . . . . . . . . . . . . . . . . 28
Teslameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
External fresh-gas outlet with an additional
switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Accessory Mounting . . . . . . . . . . . . . . . . . . . . . . 32
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Symbol Definition . . . . . . . . . . . . . . . . . . . . . . . . 35
Operation Concept . . . . . . . . . . . . . . . . . . . . . . 37
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
The Screen Display . . . . . . . . . . . . . . . . . . . . . . 39
Rotary Knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Fixed Function Keys . . . . . . . . . . . . . . . . . . . . . . 40
Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Fresh Gas Control . . . . . . . . . . . . . . . . . . . . . . . 45
LED Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Gas System Color Coding . . . . . . . . . . . . . . . . . 48
Screen Color Concept . . . . . . . . . . . . . . . . . . . . 48
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Instructions for Use Fabius MRI SW 3.n
Activating the Battery . . . . . . . . . . . . . . . . . . . .
Fitting the CO2 Absorber on the Compact
Breathing System . . . . . . . . . . . . . . . . . . . . . . .
Inserting the Flow Sensor . . . . . . . . . . . . . . . . .
Connecting the Compact Breathing System . . .
Installing the Drägersorb CLIC Adapter . . . . . .
Connecting the Waste Gas Outlet Port . . . . . . .
Installing the Breathing Bag Extension and
Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting Pipeline Supply of N2O, AIR and
O2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the Reserve Gas Cylinders for
N2O, AIR and O2 ( for Pin-Index Mounting) . . .
Connecting the Reserve Gas Cylinders for
N2O, AIR and O2 (for Cylinders with Threaded
Connectors). . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the AGSS Anesthetic Gas
Scavenging System. . . . . . . . . . . . . . . . . . . . . .
Connecting the Suction System . . . . . . . . . . . .
Connecting the Breathing Hoses and
Breathing Bag . . . . . . . . . . . . . . . . . . . . . . . . . .
Inserting a new O2 Sensor Capsule . . . . . . . . .
Connecting the O2 Sensor . . . . . . . . . . . . . . . .
Connecting the Pressure Sensor . . . . . . . . . . .
Connecting the Breathing Pressure Gauge. . . .
Connecting the Flow Sensor . . . . . . . . . . . . . . .
Connecting the APL Bypass and PEEP/PMAX
Hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparing the Ventilator. . . . . . . . . . . . . . . . . . .
Ventilator Safety Features . . . . . . . . . . . . . . . . .
Installing Vaporizers . . . . . . . . . . . . . . . . . . . . .
Connecting Auxiliary Equipment . . . . . . . . . . . .
Auxiliary power outlets . . . . . . . . . . . . . . . . . . .
Positioning the Fabius MRI at MRT System . . .
Connecting AC Power . . . . . . . . . . . . . . . . . . . .
Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Daily and Pre-use Checkout . . . . . . . . . . . . . . .
50
51
52
52
54
55
56
57
58
61
62
64
65
68
68
69
69
70
70
71
71
72
74
75
76
78
79
80
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . 81
Powering-Up the Machine . . . . . . . . . . . . . . . . . 82
Power-Up Standby Screen . . . . . . . . . . . . . . . . 83
Checking Readiness for Operation . . . . . . . . . . 83
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Power-Up Standby Screen . . . . . . . . . . . . . . . . 86
5
Page 6
Contents
Setting Fresh Gas Flow . . . . . . . . . . . . . . . . . . . 86
Setting Vaporizer Concentration. . . . . . . . . . . . . 88
O2 Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Low Flow Anesthesia . . . . . . . . . . . . . . . . . . . . . 90
Nitrogen Wash-Out (If Required) . . . . . . . . . . . . 90
Replacing CO2 Absorbent . . . . . . . . . . . . . . . . . 90
Ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Ventilator Safety Features . . . . . . . . . . . . . . . . 110
Changing Patients . . . . . . . . . . . . . . . . . . . . . . 111
Ending Operation . . . . . . . . . . . . . . . . . . . . . . . 112
End of Vaporizer Use . . . . . . . . . . . . . . . . . . . . 113
Using the external fresh-gas outlet with an
additional switch . . . . . . . . . . . . . . . . . . . . . . . . 114
Preparing for Storage or Transport. . . . . . . . . . 119
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Oxygen Monitoring . . . . . . . . . . . . . . . . . . . . . . 128
O2 Monitoring Disabled . . . . . . . . . . . . . . . . . . 132
Respiratory Volume Monitoring . . . . . . . . . . . . 133
Breathing Pressure Monitoring. . . . . . . . . . . . . 135
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 137
Configuration Functions in Standby Mode . . . . 138
Configuration during Operation . . . . . . . . . . . . 159
Fault-Cause-Remedy . . . . . . . . . . . . . . . . . . . 165
Reinstalling the Suction System . . . . . . . . . . . 191
Checking Readiness for Operation . . . . . . . . . 192
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . 193
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Routine Maintenance . . . . . . . . . . . . . . . . . . . 197
Checking Readiness for Operation . . . . . . . . . 199
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Disposal of the Medical Device . . . . . . . . . . . . 202
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 203
MRI Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ambient Conditions . . . . . . . . . . . . . . . . . . . . .
Machine Data . . . . . . . . . . . . . . . . . . . . . . . . .
Tesla Sensor . . . . . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic Compatibility (EMC) . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . .
Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
204
204
204
206
207
212
212
212
212
215
216
218
220
221
221
222
Power Failure Backup . . . . . . . . . . . . . . . . . . . 166
Ventilator Fail State . . . . . . . . . . . . . . . . . . . . . 168
Overriding the Ventilator. . . . . . . . . . . . . . . . . . 168
Fault-Cause-Remedy . . . . . . . . . . . . . . . . . . . . 170
Appendix 1 - Daily and Pre-use Checkout
Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Imaging Test Protocol (ITP) Overview: . . . . . . 233
Safety information on reprocessing . . . . . . . . . 176
Pre-cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Reprocessing methods. . . . . . . . . . . . . . . . . . . 176
Removing the Compact Breathing System. . . . 179
Removing Parts of the Ventilator . . . . . . . . . . . 181
Removing anesthetic gas scavenging system
(AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Removing the Suction System . . . . . . . . . . . . . 182
Reprocessing Breathing system. . . . . . . . . . . . 182
Care List for Fabius MRI Components . . . . . . . 184
Reassembling the Breathing System . . . . . . . . 186
Reinstalling the Ventilator . . . . . . . . . . . . . . . . . 188
Reinstalling the Scavenger System . . . . . . . . . 189
6
Appendix 2 - Imaging Test Protocol . . . . . . 233
Appendix 3 - Record of Transfer and
Equipment Installation Drawing. . . . . . . . . . 235
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
Instructions for Use Fabius MRI 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
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 MRI 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 16 and in conjunction with appropriate patient monitoring
(see page 9). Strictly observe all WARNING
and CAUTION statements throughout this
Instruction 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 9052103 en (1st 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 associated Assembly Instructions and
Instructions for Use.
Instructions for Use Fabius MRI 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 MRI 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 these Instructions for Use or in the device-specific Instructions for Use.
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibility (EMC) pursuant to international EMC standard
IEC 60601-1-2
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 207.
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 MRI:
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 decision on individual
measured values or monitoring parameters.
Instructions for Use Fabius MRI 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 MRI anesthesia workstation must be thoroughly
familiar with this instruction manual.
WARNING
Do not use conductive breathing hoses or
face masks.
They may cause burns during HF surgery.
WARNING
This MR conditional anesthesia workstation
has been tested with magnets with field
strengths of 1.5 tesla and 3 tesla by a fringe
field strength of 40 mtesla (400 gauss). Use of
the machine with higher strengths could
result in ventilator and device malfunction.
Additionally, unmanageable attractive forces
could lead to serious injury.
Instructions for Use Fabius MRI SW 3.n
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 machine, 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.
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 system. 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
Always lock the caster brakes after the
Fabius MRI has been positioned in the MRI
scanner room. Magnetic attractive forces
between the magnet and the anesthesia
machine may cause unintentional movement
of the anesthesia machine if the casters are
unlocked.
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 flammable substances are used for disinfection.
11
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For Your Safety and that of Your Patients
WARNING
Explosive anesthetics, such as ether or cyclopropane, must not be used due to the risk of
fire.
WARNING
Do not use conductive breathing hoses or
face masks.
They may cause burns during HF surgery.
WARNING
Do not apply unregulated suction to the
patient circuit when using this device.
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.
WARNING
Remove any equipment mounted to 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
Do not bring any ferromagnetic tools or equipment into the scanning room.
Ferromagnetic objects (made of steel, iron, or
stainless steel) are strongly attracted to the
magnet and can become harmful projectiles.
WARNING
Be careful in handling the power cord and
main power plug. These parts still contain
minor magnetic components. The power cord
can be attracted to MRI system.
WARNING
Do not use any type of Desflurane vaporizer in
the MR environment. In an MR environment
functionality of the Desflurane vaporizer will
be compromised.
WARNING
A pre-use checkout procedure must be performed immediately before each use of the
Fabius MRI. A recommended procedure is
provided in this Instruction for Use, see
“Appendix 1 - Daily and Pre-use Checkout
Form” on page 225.
WARNING
Do not place any object on this machine
unless it is specifically labeled to be used in
an MR scanning room and on a Fabius MRI
anesthesia system. Objects placed on this
machine that are not designed for use with
this anesthesia system may be strongly
attracted to the magnet and may cause serious injury or death when the machine is used
in an MR scanning room.
WARNING
All the procedures described in this manual
require that any use of ferromagnetic tools is
done only while the Fabius MRI is out of the
scanner room.
12
Instructions for Use Fabius MRI SW 3.n
Page 13
For Your Safety and that of Your Patients
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 electrical
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 hospitalgrade grounded (regarding national regulations) 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.
WARNING
The Fabius MRI and its patient connections
must be carefully positioned so that the
patient cannot be disconnected when being
removed from the MRT system.
WARNING
When moving the anesthesia machine,
remove all monitors and equipment from the
top shelf and hinged arms, remove the
absorber system, vaporizers, and reserve gas
cylinders, push in the writing tray, and use
only the machine handles to push or pull the
unit (see “Accessory Mounting” on page 32).
The anesthesia machine should only be
moved by people who are physically capable
of handling its weight. Dräger Medical recommends that two people move the anesthesia
machine to aid in maneuverability.
Exercise special care so that the machine
does not tip when moving up or down
inclines, around corners, and across thresholds (for example, in door frames and elevators). Do not attempt to pull the machine over
any hoses, cords, or other obstacles on the
floor.
CAUTION
Do not use the following non-rebreathing systems: Magill, Kuhn or Bain. They are not MR safe
or MR conditional.
Otherwise the diagnostic quality of the MRT
images will be affected.
Instructions for Use Fabius MRI SW 3.n
WARNING
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
WARNING
Use only non-rebreathing systems having a
reservoir bag in compliance with ISO 5362
and/or a pressure relief valve to ensure correct pressure at the patient connection port. If
disregarded, this could lead to personal
injury.
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
Use MR safe or MR conditional non-rebreathing
systems. Otherwise the diagnostic quality of the
MRT images will be affected.
CAUTION
Provide sufficient length of hoses for movement.
CAUTION
Communications with external equipment may be
temporarily affected by electromagnetic interference due to the use of electrosurgical equipment.
13
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For Your Safety and that of Your Patients
CAUTION
Watch hoses connected to the patient while moving the Fabius MRI.
CAUTION
Only Vapor 2000 vaporizers can by used on the
Fabius MRI in MRT scanner rooms.
CAUTION
Risk of injury and image artifacts
The Fabius MRI is designed for use in MR environment only as a system. The user should not
assume that individual components of the system
can be safely used in MR environment.
CAUTION
Risk of injury
Do not service this device while it is in the MR
environment.
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.
NOTE
Software must be installed by qualified personnel.
We recommend to contact DrägerService for software installation.
NOTE
If the correct functionality of the protective earthing
conductor or its connection to the device is doubtful, the device must be operated using the internal
power supply (battery).
14
Instructions for Use Fabius MRI SW 3.n
Page 15
Intended Use
Intended Use
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . 16
Indications for Use . . . . . . . . . . . . . . . . . . . . 16
MEDIBUS Protocol . . . . . . . . . . . . . . . . . . . . . 16
Instructions for Use Fabius MRI SW 3.n
15
Page 16
Intended Use
Intended Use
Indications for Use
Fabius MRI is an inhalation anesthesia machine for
use in MRI environments in operating, induction
and recovery rooms. It can only be used in MRI
scanner rooms with magnets 1.5 tesla and 3 tesla
at a fringe field strength of 40 mtesla (400 gauss) or
less.
The Fabius MRI is indicated as a continuous flow
anesthesia system useable in an MRI environment.
The Fabius MRI may be used for manually assisted
or automatic ventilation, delivery of gases and
anesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.
It may be used with O2, N2O, and AIR supplied by
a medical gas pipeline system or by externally
mounted gas cylinders.
Fabius MRI 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
Pressure Support (Optional)
SIMV/PS (Optional)
Manual Ventilation
Spontaneous Breathing
Fabius MRI 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.
MEDIBUS Protocol
MEDIBUS is a software protocol for use in transferring data between the Fabius MRI 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 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.
NOTE
O2 Monitoring Disabled” is a local authorized service organization-configurable option. See “O2
Monitoring Disabled” on page 132 for more information. In this case, external FiO2 monitoring must
be available.
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.
16
Instructions for Use Fabius MRI SW 3.n
Page 17
System Overview
System Overview
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Compact Breathing System (Top View) . . . . 19
Rear View (Threaded Connectors) . . . . . . . . 20
Interface Panel . . . . . . . . . . . . . . . . . . . . . . . . 21
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . 22
Vaporizer Exclusion Systems . . . . . . . . . . . . 22
Dräger Vapor Interlock 2 System (Optional) . . 22
Dräger Auto Exclusion 2-Vaporizer Mount
(Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Auxiliary Oxygen Flowmeter . . . . . . . . . . . . 24
O2 Flush Button . . . . . . . . . . . . . . . . . . . . . . . 25
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Writing Table . . . . . . . . . . . . . . . . . . . . . . . . . 28
Communication Port . . . . . . . . . . . . . . . . . . . 28
Teslameter . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Location of the Sensors . . . . . . . . . . . . . . . . . . 29
External fresh-gas outlet with an additional
switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Accessory Mounting . . . . . . . . . . . . . . . . . . . 32
Maximum Weight Loads . . . . . . . . . . . . . . . . . 33
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 34
Symbol Definition . . . . . . . . . . . . . . . . . . . . . 35
Instructions for Use Fabius MRI SW 3.n
17
Page 18
System Overview
Front View
1
23
4
5
5
15
6
14
13
≤ 40 mtesla (400 gauss)
7
12
8
11
9
113
10
1
Ventilator control panel (settings for ventilation
parameters and airway monitoring)
2 Total fresh gas flowmeter
3 Display screen
4 Interlock or Auto Exclusion Vapor mount
5 Additional alarm indicators
6 Fresh gas controls
7 Gauges (Pin-Index cylinders)
8 Writing table
9 Storage drawers
10 Central brake
18
11
12
13
14
15
Absorber
Compact Breathing System (COSY)
Oxygen flush button
Ventilator
Auxiliary oxygen flowmeter
Instructions for Use Fabius MRI SW 3.n
Page 19
System Overview
Compact Breathing System (Top View)
1
2
3 4
13
5
12
11
6
7
9
8
064
10
1
2
3
4
5
6
7
8
9
10
11
12
PEEP/PMAX valve connection port
Bag holder
Expiratory valve
Flow-sensor guard (flow-sensor protection)
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
13 Sample gas return port
Instructions for Use Fabius MRI SW 3.n
19
Page 20
System Overview
Rear View (Threaded Connectors)
1 2
3
4
5
6
7
11
10
8
103
9
1
2
3
4
5
6
7
20
Connector for medical gas pipeline supply (central supply)
Connector for cylinders (threaded connectors)
Type plate
Ventilator hose connection
Interface panel
ON/OFF switch
Fuse
8
9
10
11
Compact Breathing System (COSY)
Power cable connection
Potential equalization pin
Auxiliary power outlets
Instructions for Use Fabius MRI SW 3.n
Page 21
System Overview
Interface Panel
1
2
3
4
5
7
6
074
8
1
2
3
4
5
6
7
8
COM 1 (for Service or fiber optic cable
(8608376) only)
Oxygen Sensor
Volume Sensor
ON/OFF switch
APL
Fuse
Breathing Pressure
PEEP
Instructions for Use Fabius MRI SW 3.n
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Page 22
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, or Sevoflurane.
WARNING
Do not use any type of Desflurane vaporizer in
the MR environment. In an MR environment
functionality of the Desflurane vaporizer will
be compromised.
CAUTION
Only Vapor 2000 vaporizers can by used on the
Fabius MRI in MRT scanner rooms.
For complete information, consult the appropriate
Instruction for Use provided with the vaporizer.
Vaporizer Exclusion Systems
The exclusion systems available for the
Fabius MRI 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.
22
Instructions for Use Fabius MRI SW 3.n
Page 23
System Overview
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 MRI.
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.
Instructions for Use Fabius MRI SW 3.n
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System Overview
Auxiliary Oxygen Flowmeter
The auxiliary oxygen flowmeter 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.
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
069
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
ASTM F1850-22(2005) §76
Instructions for Use Fabius MRI SW 3.n
Page 25
System Overview
O2 Flush Button
A manually operated O2 flush button (1) is located
on the front of the machine. When actuated, the
valve delivers an unmetered flow of at least
35 L/min to the breathing system and breathing bag
while bypassing the ventilator. The Fabius MRI
does not need to be switched on in order to use the
O2 flush.
037
1
Instructions for Use Fabius MRI SW 3.n
25