NORTH AMERICAN DRÄGER Drager Fabius Anesthesia User manual
Technical Documentation
Fabius MRI
Anesthesia System
WARNING!
Each servicing and/or testing of the device
requires full understanding of this Technical Documentation. Carefully read this
Technical Documentation and any applicable Instructions for Use prior to any use of
the device.
Revision 1.0
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9036337
Because you care
Inhaltsverzeichnis
General
1 Symbols and Definitions 6
2 Notes 6
1 Cautions and Warnings 8
1.1 Patient safety .......................................................................................................................... 8
1.2 Warnings ................................................................................................................................ 8
Function Description
1 Abbreviations 12
2 General 12
3 Basics of magnetic resonance tomography 12
4 Safety instructions 12
5 General Information about the Fabius MRI 14
6 Battery backup 17
7 Fabius MRI Piping Diagram 18
8 Function description of the gas box 18
9 SORC (Sensitive Oxygen Ratio Controller) 19
10 Cosy 2.6 breathing system 21
10.1 Ventilation mode ................................................................................................................... 25
10.2 Manual ventilation ................................................................................................................ 26
10.3 Spontaneous breathing ........................................................................................................ 27
10.4 Volume/pressure control ventilation mode ........................................................................... 29
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10.5 Cosy 2.6 absorber ................................................................................................................ 31
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Inhaltsverzeichnis
11 Lung ventilator 31
11.1 Pressure limiting valve ..........................................................................................................34
11.2 Auxiliary-air valve .................................................................................................................34
12 Pneumatic assembly 35
12.1 PEEP/Pmax valve control .....................................................................................................35
12.2 APL bypass valve control .....................................................................................................36
13 Control PCB 36
14 Function Description: Control PCB 37
15 Control panel assembly 38
16 FiO2 measurement 40
17 Respiratory flow measurement 41
18 Gas flow rate measurement 42
19 Anesthetic vaporizer(s) 43
Maintenance Procedures
1 Diagnostics 46
Annex
Parts catalog
Test List
4
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General
5
General Fabius MRI
1 Symbols and Defini-
tions
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 or servicing of the equipment.
Definitions:
Inspection = examination of actual condition
Maintenance = measures to maintain specified condition
Repair = measures to restore specified condition
Servicing = inspection, maintenance, and repair
2Notes This Technical Documentation conforms to the IEC 60601-1 standard.
Read each step in every procedure thoroughly before beginning any test.
Always use the proper tools and specified test equipment. If you deviate from
the instructions and/or recommendations in this Technical Documentation,
the equipment may operate improperly or unsafely, or the equipment could
be damaged.
Dräger recommends that only Dräger supplied repair parts be used for maintenance. Otherwise the correct functioning of the device may be compromised.
The maintenance procedures described in this Technical Documentation may
be performed by properly trained service personnel only. These maintenance
procedures do not replace inspections and servicing by the manufacturer.
This Technical Documentation is for the purpose of information only. Product
descriptions found in this Technical Documentation are in no way a substitute
for reading and studying the Instructions for Use.
NOTE
Unless otherwise stated, reference is made to laws, regulations or standards (as amended) applicable in the Federal Republic of Germany for
equipment used or serviced in Germany. Users or technicians in all other
countries must verify compliance with local laws or applicable international
standards.
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NOTE
If the test values are not met, please contact your local service organization.
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General Fabius MRI
1 Cautions and Warn-
ings
1.1 Patient safety The design of the medical device, the accompanying literature, and the label-
ing 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.
1.2 Warnings 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.
WARNING
Any person involved with the setup, operation, or maintenance of the
Fabius MRI anesthesia system must be thoroughly familiar with the
instruction manual.
CAUTION
Only the accessories indicated on the list of accessories 8607185 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.
WARNING
This MR conditional anesthesia machine has been tested with magnets with field strengths of 1.5 tesla and 3 tesla by a fringe field
strength of 40 mtesla. Use of the machine with higher strengths could
result in ventilator and device malfunction. Additionally, unmanageable attractive forces could lead to serious injury.
CAUTION
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.
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CAUTION
Only the combinations approved by Dräger Medical, with monitoring may
be used. Otherwise the correct functioning of the device maybe compromised.
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.
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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
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
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.
CAUTION
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.
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General Fabius MRI
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Function Description
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MRI Fabius MRI
1 Abbreviations MRI → Magnetic Resonance Imaging
MRT → Magnetic Resonance Tomography
Tesla (T) → Magnetic flux density/induction
HF → High Frequency
2 General Fabius MRI is a variant of the Fabius GS/Tiro which operates in a MRI envi-
ronment.
3 Basics of magnetic
resonance tomography
Magnetic resonance (MR) or nuclear magnetic resonance imaging is a diagnostic technique which produces high-resolution pictures (images) of the
human body without the use of dangerous X-rays.
Signals are generated and received using a strong magnet and a radio-frequency antenna. The resulting images are evaluated and displayed by a
computer.
4 Safety instructions As the MR scanner generates very strong magnetic fields, special safety pre-
cautions must be taken.
Strong, high-frequency magnetic fields can heat metal. There is a risk of
burns caused by metal objects on the person or implants.
Ferromagnetic (metal) objects can also be accelerated with great force and
could cause injury.
The data content of cards featuring magnetic strips (such as credit cards)
may be wiped.
Before entering the MR scanner room remove all metal objects from your person. This includes:
–Coins
–Key
–Watches
– Items of jewelry
–Tools
– Cards with magnetic strips
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Persons with implants should consult a specialist doctor before entering the
room.
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Metal implants inside the body may cause pain and injuries when they are
introduced into the magnetic field. Therefore, patients with certain implants
are contraindicated from MR imaging. Prior to MR examination, the MR physician or technologist will ask the patients about the following risk factors:
– cardiac pacemakers
– metal plates, nails, or metal implants
– artery clamps
– artificial cardiac valves
– intrauterine contraceptive devices
– body jewelry
– cosmetic decorations or tattoos (the dyes used may contain metal flakes
or slivers)
– shrapnel
– pregnancy (should be reported)
According to current knowledge, damaging effects are unlikely at the magnetic field strength used (up to 3.0 tesla).
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Function description Fabius MRI
5 General Information
about the Fabius
MRI
The Fabius MRI comprises the following assemblies:
– Display and control panel
– Flowmeter assembly
– Gas box: Gas inlet assembly and related items
– Breathing system
– Pneumatic assembly
– Lung ventilator
– Anesthetic vaporizer(s)
– Trolley
– Cover with additional alarm
Monitoring, electrical connections and gas connections as shown in Fig. 1,
Fig. 2, Fig. 3, Fig. 4 and Fig. 5.
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Fig. 1 Front view of Fabius MRI anesthesia system, for legend see
Table 1
Table 1 Legend to Fig. 1
No. Name
1 Breathing system Cosy 2.6
2 Lung ventilator
3 Oxygen flowmeter (auxiliary)
4 Additional alarm lights
5 Display
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No. Name
6 Control panel
7 Anesthetic vaporizer mount
8 Pipeline supply manometers
9 Flow control valves
10 Total fresh gas flowmeter
11 Cylinder Manometer
12 Trolley
13 O
flush key
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Fig. 2 Rear view with interface plate; legend, see Tab le 2
Table 2 Legend to Fig. 2
No. Name
1 Serial communication ports
2 O2 sensor connection
3 Spirolog sensor cable
4 ON/OFF switch
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Function description Fabius MRI
No. Name
5 Battery fuse
6 Airway pressure connection
7 Tube connection for PEEP valve
8 Tube connection for APL bypass valve
Fig. 3 Rear view showing gas pipeline and PIN index cylinder connec-
tions, for legend see Tab le 3
Table 3 Legend to Fig. 3
No. Name
1 N2O PIN index cylinder connection
2 O2 or AIR PIN index cylinder connection
3 O2 PIN index cylinder connection
Fig. 4 Central tube connections and high-pressure connections
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Fig. 5 Multiple socket strip
6 Battery backup Fabius MRI battery power is provided by two rechargeable series-connected
12 V batteries. These batteries remain on charge as long as the machine is
plugged into an active AC outlet. Should power supply fail while the machine
is in operation, the batteries will allow the machine to continue operating for a
minimum of 45 minutes, provided that the batteries are fully charged.
The batteries are accessible by opening the ventilator compartment. The
3.15A battery fuse is located at the back of the control box.
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Fig. 6 Battery backup arrangement
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Function description Fabius MRI
7 Fabius MRI Piping
Diagram
Fig. 7 Fabius MRI piping diagram, variant US 2-Gas
8 Function descrip-
tion of the gas box
The supply gases flow through the filters and non-return valves in the gas
inlet assembly. Pipeline supply pressures are indicated on pipeline pressure
gauges located on the flowmeter assembly. Cylinder pressure gauges are
located on the trolley assembly. The pressures of O2 and N2O delivered to
the flowmeter assembly are set by regulators on the gas inlet assembly.
If the O2 supply fails or its pressure decreases below a certain limit, the O2
low alarm switch generates an alarm.
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Fig. 8 Gas Box Function Diagram, part 1
If the O2 flush button is pressed, oxygen is delivered to the fresh-gas outlet.
The fresh-gas ejector prevents the fresh gas from flowing back into the anesthetic vaporizer. This avoids an increase in anesthetic gas concentration.
9 SORC (Sensitive
Oxygen Ratio Controller)
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Fig. 9 Gas Box Function Diagram, part 2
The SORC is a control element that functions like an N2O shut-off device and
ensures a vital O2 concentration in the fresh gas. In the event of an O2 shortage, the SORC limits the N2O flow such that the O2 concentration in the
fresh gas does not decrease below 21 vol.%.
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Function description Fabius MRI
If the O2 flow control valve is closed or if the O2 flow is lower than or equal to
200 mL/min, the SORC interrupts the N2O flow.
N2O can be added as of an O2 flow of approx. 300 mL/min. In this case, the
SORC also prevents O2 concentrations below 21 vol.%.
The SORC bypass allows the oxygen to bypass the resistor in the SORC
when O2 flows above 10 L/min are needed.
Fig. 10 SORC function diagram, part 1
The O2 and N2O flows are adjusted with the flow control valves.
Resistors located at the outlets of the SORC generate back-pressures. These
back-pressures exert a force on the control diaphragms of the SORC. The O2
back-pressure opens the SORC. The N2O back-pressure closes the SORC.
The pressure ratio at the control diaphragm affects the N2O flow.
The resistors and the spring force are dimensioned such that a minimum concentration of 21 vol.% of O2 is always ensured. The maximum O2 flow is
approx. 12 L/min.
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Fig. 11 SORC function diagram, part 2, for legend see Tab l e 4
10 Cosy 2.6 breathing
system
Table 4 Legend to Fig. 11
No. Name
1 Control diaphragms
2Resistors
3 N2O non-return valve
4 Operating-point adjusting screw
5 Flow control valves
The Cosy 2.6 breathing system allows three modes of patient ventilation:
– Manual ventilation and spontaneous breathing
– Volume controlled ventilation
– Pressure controlled ventilation
On APL valves with control knob, switching from “IPPV/SPONT” to “MAN” is
carried out by turning the knob.
In the “MAN” position, the breathing system is closed to atmosphere. This
position is used for manual ventilation of the patient. The APL valve opening
pressure can be adjusted from 5 to 70 cmH2O (mbar).
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In the “SPONT” switch position the APL valve is open to atmosphere. This
position is used for spontaneous breathing.
Using the control box and the PEEP/Pmax valve, the pressure limit (Pmax)
can also be adjusted during volume control from 15 cmH2O (mbar) to
70 cmH2O (mbar) via the membrane keypad.
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Function description Fabius MRI
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Fig. 12 Cosy 2.6 breathing system, for legend see Tab l e 5
Table 5 Legend to Fig. 12
No. Name
1 Inspiratory connection
2 Inspiratory valve and O2 sensor connection
3 Fresh-gas decoupling valve
4 APL bypass valve
5 MAN/SPONT APL valve
6 Sample gas connection
7 Anesthetic gas scavenging port
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No. Name
8 Fresh-gas port
9 Lung ventilator port
10 Absorber
11 Pressure sensor connection
12 Breathing bag hook
13 Flow sensor (Spirolog) (not shown)
14 Expiratory connection
15 PEEP/Pmax valve
16 Breathing bag terminal and standby holder for Y-piece
17 Expiratory valve
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Function description Fabius MRI
Fig. 13 Function diagram of Fabius MRI - Cosy 2.6 breathing system
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10.1 Ventilation mode
Fig. 14 Functional diagram of the ventilation mode, for legend see Tab le
6
Table 6 Legend to Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19,
Fig. 20
No. Name
1 Absorber
2 Fresh gas inlet
3 Fresh-gas decoupling
4 Lung ventilator
5 Inspiratory valve
6 Pressure sensor
7 Oxygen sensor
8 Inspiratory tube
9Y-piece
10 Lung
11 Expiratory tube
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12 Flow sensor
13 PEEP/Pmax valve
14 Expiratory valve
15 APL bypass valve
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Function description Fabius MRI
No. Name
16 APL valve
17 Non-return valve
18 Manual breathing bag
10.2 Manual ventilation
Manual ventilation: General
Manual ventilation: Inspiration
During manual ventilation, the APL valve is set to the “MAN” position. The
safety valve of the patient system is activated.
The item numbers mentioned in the following paragraphs refer to Fig. 15.
During inspiration, expiratory valve 14 remains closed. When the operator
compresses the manual breathing bag 18 the gas mixture (expiratory gas
and fresh gas 2) flows through the absorber 1, the fresh-gas decoupling valve
3, the inspiratory valve 5, the O2 sensor 7, the inspiratory hose 8, and the Ypiece 9 into the patient’s lung 10. The pressure sensor 6 measures the airway pressure. The ventilation pressure is limited by the APL valve 16. Any
excess amount of the gas mixture flows through the APL valve and the nonreturn valve 17 to the anesthetic gas scavenging system.
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Manual ventilation: Expiration
Fig. 15 Manual ventilation (inspiration) - Cosy 2.6 breathing system; for
legend see Tab l e 6
During expiration, the inspiratory valve remains closed thus preventing the
expiratory gas from flowing back into the inspiratory branch.
The item numbers mentioned in the following paragraphs refer to Fig. 16.
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After releasing the breathing bag 18, the expiratory gas from the lung 10
flows through the expiratory tube 11, the flow sensor 12, the PEEP/Pmax
valve 13, the expiratory valve 14, into the manual ventilation bag and through
the absorber 18. At the same time, new fresh gas 2 flows into the manual
ventilation bag.
10.3 Spontaneous breathing
Spontaneous breathing:
General
Spontaneous breathing:
Inspiration
Fig. 16 Manual ventilation (expiration) - Cosy 2.6 breathing system; for
legend see Table 6
A prerequisite for spontaneous breathing is that the patient is supplied with a
sufficient amount of fresh gas. The APL valve selector must be set to the
“SPONT” position. No pressure builds up in the compact breathing system.
During inspiration, the expiratory valve remains closed thus preventing
rebreathing of expiratory gas containing CO2.
The item numbers mentioned in the following paragraphs refer to Fig. 17.
The patient inhales the gas mixture (expiratory gas and fresh gas 2) from the
manual ventilation bag 18. The gas mixture flows through the fresh-gas
decoupling valve 3, the inspiratory valve 5, the O2 sensor 7, the inspiratory
hose 8, and through the Y-piece 9 into the lung 10. The pressure sensor 6
measures the airway pressure.
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