MAGNETOM Family Operator Manual - MR System syngo MR E11

MAGNETOM Family Operator Manual – MR System syngo MR E11

Legend

Indicates a hint Provides information on how to avoid operating errors or information emphasizing important details Indicates the solution to a problem Provides troubleshooting information or answers to frequently asked questions Indicates a list item Indicates a prerequisite A condition that has to be fulfilled before starting a particular operation Indicates a single-step operation Indicates steps within operating sequences

Italic

Used for references and for table or figure titles Used to identify a link to related information as well as previous or next steps

Bold

Used to identify window titles, menu items, function names, buttons, and keys, for example, the Save button

Blue

Used to emphasize particularly important sections of the text

Courier

Used for on-screen output of the system including code-related elements or commands

Courier

Identifies inputs you need to provide

Menu > Menu Item <variable> &$87,21

Used for the navigation to a certain submenu entry Identifies variables or parameters, for example, within a string CAUTION Used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury or material damage. CAUTION consists of the following elements: ◾ Information about the nature of a hazardous situation ◾ Consequences of not avoiding a hazardous situation ◾ Methods of avoiding a hazardous situation

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WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

:$51,1*

WARNING consists of the following elements: ◾ Information about the nature of a hazardous situation ◾ Consequences of not avoiding a hazardous situation ◾ Methods of avoiding a hazardous situation

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Legend

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Table of contents

1 Introduction

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1.1

Layout of the operator manual

12

1.2

The current operator manual

12

1.3

Intended use

13

1.4

Authorized operating personnel 1.4.1 Definitions of different persons

13 14

2 Safety

15

2.1

Preface about safety 2.1.1 Hazards and risks 2.1.2 Common causes of accidents 2.1.3 Responsibility

15 15 15 15

2.2

Common/permanently existing hazards 2.2.1 Electromagnetic fields 2.2.2 Safety instructions on the static magnetic field 2.2.3 Safety instructions on RF and gradient fields 2.2.4 Contraindications 2.2.5 Mechanical hazards 2.2.6 Compatibility

16 16

2.3

What else must be observed? 2.3.1 Ambient conditions 2.3.2 Access to the examination room 2.3.3 Noise development 2.3.4 Patient care 2.3.5 Artifacts and imaging errors 2.3.6 Maintenance/repair 2.3.7 Signs and symbols 2.3.8 System owner-related advices 2.3.9 Coils/quality assurance

29 29 29 30 31 32 37 37 40 40

2.4

In case of emergency 2.4.1 Emergency switches 2.4.2 Medical emergency 2.4.3 Coolant accidents 2.4.4 Fire/Fire fighting

40 40 43 44 45

17 19 22 24 27

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Table of contents

3 MR system components

47

3.1

Overview MR system 3.1.1 About function 3.1.2 Super-conducting magnet 3.1.3 Electronics cabinets 3.1.4 RF coils

47 47 47 47 49

3.2

syngo Acquisition Workplace 3.2.1 Host 3.2.2 Data recording 3.2.3 Monitor 3.2.4 Keyboard 3.2.5 Mouse 3.2.6 syngo MR Workplace (optional)

49 50 50 50 51 52 53

3.3

System control 3.3.1 Description 3.3.2 Operating the Dot display

53 53 57

3.4

Patient table 3.4.1 Description 3.4.2 Operating the patient table

57 57 59

3.5

Dockable patient table 3.5.1 Description 3.5.2 Operating the dockable patient table

64 64 66

3.6

Laser light localizer 3.6.1 Using the laser light localizer

70 71

3.7

Alarm box 3.7.1 Description 3.7.2 Checks

72 72 73

3.8

Intercom 3.8.1 Description 3.8.2 Operating the intercom

74 74 76

3.9

In-Room syngo Acquisition Workplace 3.9.1 Description 3.9.2 Operating the In-Room syngo Acquisition Workplace

77 77

3.10 Other components and accessories 3.10.1 Gradient supervision

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78 81 81

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Table of contents

4 Physiological imaging 4.1

Triggering methods 4.1.1 Prospective triggering 4.1.2 Retrospective gating

83 83 84

4.2

Physiological Measurement Unit (PMU) 4.2.1 Description 4.2.2 Preparing the measurement

84 84 89

4.3

ECG triggering 4.3.1 Description 4.3.2 Performing

91 91 93

4.4

Pulse triggering 4.4.1 Description 4.4.2 Performing

95 95 95

4.5

Respiratory triggering 4.5.1 Description 4.5.2 Performing

96 96 96

4.6

External triggering 4.6.1 Input for external trigger signal 4.6.2 Performing

97 97 98

5 MR system operation

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99

5.1

Daily functionality checks 5.1.1 Checking the functionality and cleanliness

99

5.2

Starting up and shutting down the MR system 5.2.1 Starting the system (System On) 5.2.2 Shutting down the system (System Off) 5.2.3 Shutting down the syngo MR Workplace 5.2.4 Starting/ending Standby

100 101 103 104 105

5.3

Preparing the MR system 5.3.1 Connecting the squeeze bulb 5.3.2 Setting tunnel conditions

106 106 106

5.4

Preparing the patient 5.4.1 Informing the patient

107 107

5.5

Physiological effects 5.5.1 Operating modes 5.5.2 Exposure to low frequency electromagnetic fields 5.5.3 Exposure to RF electromagnetic fields

108 108

99

110 112

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Table of contents

5.6

Starting/Stopping the measurement 5.6.1 Starting the measurement 5.6.2 Stopping the measurement

6 Maintenance 6.1

117

Cleaning 6.1.1 Cleaning the patient table, the straps, the plugs and connectors 6.1.2 Cleaning and disinfecting the receptors 6.1.3 Cleaning system components 6.1.4 Cleaning the LCD monitor/video display 6.1.5 Cleaning the camera lens 6.1.6 Cleaning the data carrier 6.1.7 Care and cleaning of floors

117

Return and disposal 6.2.1 MR System 6.2.2 Packaging 6.2.3 Batteries and accumulators

121 121 121 121

7 Appendix: regulatory information

123

6.2

117 118 118 119 120 120 120

7.1

Medical devices of other manufacturers

123

7.2

CE for Physiological Measurement Unit (PMU)

124

Index

10

116 116 116

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Introduction

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1 Introduction The MR system operator manual covers safety information and general system information. This manual is valid for the following systems:

MAGNETOM Aera (1.5T)

MAGNETOM Skyra (3T)

MAGNETOM Prisma (3T)

MAGNETOM Avantofit (1.5T)

MAGNETOM Skyrafit (3T)

MAGNETOM Prismafit (3T)



Not all MR systems are released for all countries! Contact your Siemens Sales Organization about the systems available in your country. In order to operate the MR system accurately and safely, the operating personnel must have the necessary expertise as well as knowledge of the complete operator manual. The operator manual must be read carefully prior to using the MR system.

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1

Introduction

1.1 Layout of the operator manual Your complete operator manual is split up into several volumes to improve readability. Each of these individual operator manuals covers a specific topic: ◾ Hardware components (system, coils, etc.) ◾ Software (measurement, evaluation, etc.) Another element of the complete operator manual is the information provided for the system owner of the MR system. The extent of the respective operator manual depends on the system configuration used and may vary.



All components of the complete operator manual may include safety information that needs to be adhered to. The operator manuals for hardware and software address the authorized user. Basic knowledge in operating PCs and software is a prerequisite.

1.2 The current operator manual This manual may include descriptions covering standard as well as optional hardware and software. Contact your Siemens Sales Organization with respect to the hardware and software available for your system. The description of an option does not infer a legal requirement to provide it. The graphics, figures, and medical images used in this operator manual are examples only. The actual display and design of these may be slightly different on your system. Male and female patients are referred to as “the patient” for the sake of simplicity.

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1.3 Intended use Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.



The MAGNETOM MR system is not a device with measuring function as defined in the Medical Device Directive (MDD). Quantitative measured values obtained are for informational purposes and cannot be used as the only basis for diagnosis.



For the USA only: Federal law restricts this device to sale, distribution and use by or on the order of a physician.



Your MR system is a medical device for human use only!

1.4 Authorized operating personnel The MAGNETOM MR system must be operated according to the intended use and only by qualified persons with the necessary knowledge in accordance with country-specific regulations, e.g. physicians, trained radiological technicians or technologists, subsequent to the necessary user training.

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1

Introduction

This user training must include basics in MR technology as well as safe handling of MR systems. The user must be familiar with potential hazard and safety guidelines the same way the user is familiar with emergency and rescue scenarios. In addition, the user has to have read and understood the contents of the operator manual. Please contact Siemens Service for more information on available training options and suggested duration and frequency of such training.

1.4.1

Definitions of different persons Term used

Explanation

User/Operator/ Operating personnel

Person who operates the system or software, takes care of the patient or reads images

System owner

Person who is responsible for the MR environment. This includes legal requirements, emergency plans, employee information and qualifications, as well as maintenance/repair.

MR worker

Person who works within the controlled access area or MR environment

Typically physicians, trained radiological technicians, or technologists

User/Operator as well as further personnel (for example, cleaning staff, facility manager, service personnel) Siemens Service/service personnel

Group of specially trained persons who are authorized by Siemens to perform certain maintenance activities References to “Siemens Service” include service personnel authorized by Siemens.

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Safety

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2 Safety 2.1 Preface about safety 2.1.1

Hazards and risks An MR system may present various hazards. Some occur only during the examination, while others exist permanently and thus are also relevant to non-users (e.g. cleaning personnel). The various hazards and the corresponding safety instructions are explained in the safety chapter of this operator manual.

2.1.2

Common causes of accidents Despite safety instructions, some hazards lead to accidents time and again. In particular, this includes magnet accidents and RF burns/loop formation, as well as the use of incompatible devices and the wearing of clothing with electrically conductive materials. A detailed patient screening ensures that the patient is free of metallic objects and clothing with metallic yarns or appliqués. The following sections provide information on how to avoid the most common mistakes and the resulting safety risks. These sections were prepared based on the long-time experience of Siemens.

2.1.3

Responsibility Siemens accepts no responsibility for the safety, reliability, and performance of the MR system, if the MR system is not used in accordance with the instructions for use (Operator Manual, System Owner Manual). Siemens is also not responsible for any direct or indirect damages caused by incorrect operation. This includes, but is not limited to, accidents with ferromagnetic objects. This applies even if the consequences only become obvious at a later point in time.

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Safety

2.2 Common/permanently existing hazards The frequency at which the potential hazards mentioned in this section lead to accidents is still too high. Therefore, it is especially important to observe the instructions on how to avoid these dangerous situations. The most significant hazards include: ◾ Electromagnetic fields ◾ Contraindications ◾ Mechanical hazards ◾ Incompatible devices

2.2.1

Electromagnetic fields In the examination room, there are different kinds of electromagnetic fields and the resulting risks.

Fields

Most serious hazards

Static magnetic field

Movement by implants and prostheses in the body Attraction, alignment, and projectile-like acceleration of magnetizable objects ( Page 17 Safety instructions on the static magnetic field)

Gradient fields

Peripheral nerve stimulation ( Page 19 Safety instructions on RF and gradient fields)

RF fields

Warming of body tissue ( Page 19 Safety instructions on RF and gradient fields)



All persons (e.g. patients, physicians, operating and cleaning personnel, accompanying persons, and rescue personnel/fire fighters) are exposed to these fields in the examination room. Therefore, all limits and safety measures regarding electromagnetic fields equally apply to patients and MR workers. ◆ Observe prohibition signs in the area near the entrances to the MR system and the controlled access area.

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Safety

Static magnetic field/controlled access area

2

The static basic field is generated by a superconductive magnet and may extend beyond the examination room (walls, ceilings). In order to minimize the hazards mentioned, the controlled access area of the basic field is identified on the floor (0.5 mT line). Outside the controlled access area, the magnetic flux density is less than 0.5 mT. See: System owner manual

Gradient fields

RF fields

Linearly rising additional fields of variable strength - gradient fields are superimposed on the static main magnetic field in three different orientations. They may cause shifts in charge in the patient's tissue and lead to peripheral nerve stimulation. The nuclear spins of the body tissue are stimulated via pulsed electromagnetic RF fields. These RF pulses are generated by an RF transmit amplifier and transferred via RF coils to the object to be measured. RF fields lead to warming of the body tissue. In this context, an important value per body weight is the specific absorption rate or SAR. ( Page 108 Physiological effects)

Side effects

Possible undesirable side effects for MR are dizziness, heating, claustrophobia and nerve stimulation.

2.2.2

Safety instructions on the static magnetic field The list of objects in this chapter is not exhaustive. It only serves as an illustration of objects that present hazards in the presence of magnetic forces. ◆ Only use equipment specified or recommended for use in the controlled access area.

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Safety

 WARNING Movement and/or alignment of implants and prostheses in the body, as well as attraction, alignment, and projectile-like acceleration of magnetizable objects may result in very serious hazards! Injury to patient and operating personnel ◆ Do not use resuscitation devices - for example, defibrillators or oxygen bottles - in the examination room. ◆ Do not use transport trolleys, movable beds, stretchers, etc. that consist of magnetizable parts. ◆ Do not wear or carry any magnetizable objects on your person - for example, watches, pens, scissors, etc.. ◆ Use only proven MR Safe or MR Conditional accessories, parts subject to wear and tear, and disposable articles with the MR system. ◆ Use only MR Safe or MR Conditional tools and devices. ◆ Service work on the MR system may only be performed by Siemens Service. ◆ Ensure that only authorized personnel enter the controlled access area (0.5 mT exclusion zone), for example, electricians or cleaning personnel trained in MR safety. ◆ Keep the door to the examination room closed.

 WARNING Magnetizable objects introduced into the magnetic field become projectiles! Injury to patient and operating personnel ◆ Inform the operating personnel about the effect of forces on ferromagnetic parts or implants, especially on systems with a higher field strength (for example, 3T). Explain that the forces increase with the field strength of the magnet!

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Safety

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For China only: In 3-T systems medical supervision is required for all patients according to IEC 60601-2-33 (2nd edition). Dizziness during exposure

When persons (e.g. MR workers or patients) are exposed to the static magnetic field, possible effects are dizziness, light-headedness, or metallic taste, especially in 3-Tesla magnetic fields. 1 Ask the patient to lie still during the measurement. 2 Keep a sufficient distance to the magnet and avoid rapid movements of the head.

 CAUTION Dizziness, light-headedness or metallic taste in the patient‘s mouth during measurements and/or table movements in a 3Tesla magnetic field! Reaction of fear by the patient ◆ Prior to the examination, inform the patient about the possible occurrence of these symptoms. Device malfunctions

2.2.3 Patients at risk

Current loops and bore wall contact

Magnetic flux densities exceeding 0.5 mT can interfere with electronic implants or other devices. The main magnetic field may either affect or destroy electronic data carriers such as check or credit cards, hard disks, ID cards with magnetic strips and/or magnetic tapes, diskettes or pocket calculators, as well as RFID chips (Radio Frequency Identification).

Safety instructions on RF and gradient fields ◆ Do not examine patients unable to communicate potential overheating effects (e.g. small children, seriously ill, paralyzed, unconscious, sedated, or handicapped patients). Dangerous current loops may be generated when parts of the patient's body touch. These loops may lead to burns or increase the probability of stimulation. Current loops are also generated when the patient's skin contacts the tunnel lining or RF coil cables.

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2

Safety



Ensure to prevent potential current loops as shown in the red labeled illustration. Ensure the patient is positioned with proper distance (5 mm) to magnet tunnel as well as proper distance between parts of the body as shown in the green labeled illustration. ◆ To lower the effects of gradient fields or RF fields, keep a sufficient distance from the RF coils and the magnet tunnel (gradient coils), and reduce the time of exposure during measurements.

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 CAUTION The patient is wearing electrically conductive material! Incorrect patient positioning! Formation of electric current loops Peripheral nerve stimulation of the patient ◆ Ensure that the patient does not wear clothing that is wet or dampened by perspiration. ◆ Ensure that the patient is free of metallic rings, chains, or electrically conductive materials worked into items of clothing (for example, brassiere support wires, metallic appliqués or woven metallic yarns). ◆ Always position the patient so that the patient's arms are aligned with the torso and ensure that hands, arms, and legs do not touch (minimum distance: 5 mm). ◆ Ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering. ◆ To ensure this distance, use positioning aids, e.g. blankets made of linen, cotton, or paper, or dry material that is permeable to air. ◆ Ensure sufficient ventilation.

 CAUTION Heating up/ignition of synthetic blankets via the RF field during the measurement! Patient burns ◆ Use only covers made of paper, cotton or linen.

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