Fabius MRI Technical Documentation Rev 2.0

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

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10.2 Manual ventilation ... 26 10.3 Spontaneous breathing ... 27 10.4 Volume/pressure control ventilation mode ... 29 10.5 Cosy 2.6 absorber ... 31 3

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

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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

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Test List

General

5

General 1

Symbols and Definitions

Fabius MRI

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:

2

Notes

Inspection

= examination of actual condition

Maintenance

= measures to maintain specified condition

Repair

= measures to restore specified condition

Servicing

= inspection, maintenance, and repair

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.

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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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.

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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.

Fabius MRI

General

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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 Warnings

1.1

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.

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.

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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CAUTION Only the combinations approved by Dräger Medical, with monitoring may be used. Otherwise the correct functioning of the device maybe compromised.

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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.

Fabius MRI

General

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.

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CAUTION Only Vapor 2000 vaporizers can by used on the Fabius MRI in MRT scanner rooms.

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General Fabius MRI

Function Description

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MRI 1

Fabius MRI 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 environment.

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 precautions 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.

–

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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Before entering the MR scanner room remove all metal objects from your person. This includes:

Fabius MRI

MRI 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

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artery clamps

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artificial cardiac valves

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intrauterine contraceptive devices

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body jewelry

–

cosmetic decorations or tattoos (the dyes used may contain metal flakes or slivers)

–

shrapnel

–

pregnancy (should be reported)

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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 5

General Information about the Fabius MRI

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

Fig. 1

Front view of Fabius MRI anesthesia system, for legend see Table 1

Table 1

Legend to Fig. 1

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Name

1

Breathing system Cosy 2.6

2

Lung ventilator

3

Oxygen flowmeter (auxiliary)

4

Additional alarm lights

5

Display

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Monitoring, electrical connections and gas connections as shown in Fig. 1, Fig. 2, Fig. 3, Fig. 4 and Fig. 5.

Fabius MRI

Function description

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

O2 flush key

Fig. 2

Rear view with interface plate; legend, see Table 2

Table 2

Legend to Fig. 2

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Name

1

Serial communication ports

2

O2 sensor connection

3

Spirolog sensor cable

4

ON/OFF switch

15

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 connections, for legend see Table 3

Table 3

Legend to Fig. 3 Name

1

N2O PIN index cylinder connection

2

O2 or AIR PIN index cylinder connection

3

O2 PIN index cylinder connection

Central tube connections and high-pressure connections

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Fig. 4

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No.

Fabius MRI

Function description

Fig. 5

6

Battery backup

Multiple socket strip

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.

Fig. 6

Battery backup arrangement

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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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Function description 7

Fig. 7

8

Fabius MRI

Fabius MRI Piping Diagram

Fabius MRI piping diagram, variant US 2-Gas

Function description 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.

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If the O2 supply fails or its pressure decreases below a certain limit, the O2 low alarm switch generates an alarm.

Fabius MRI

Function description

Fig. 8

Gas Box Function Diagram, part 1

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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.

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SORC (Sensitive Oxygen Ratio Controller)

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.

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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.

Fabius MRI

Function description

Fig. 11

SORC function diagram, part 2, for legend see Table 4

Table 4

Legend to Fig. 11

No.

10

Cosy 2.6 breathing system

Name

1

Control diaphragms

2

Resistors

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

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). 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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On APL valves with control knob, switching from “IPPV/SPONT” to “MAN” is carried out by turning the knob.

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