Siemens MAGNETOM Skyra fit User manual

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MAGNETOM Skyrafit
Operator Manual – MR System
syngo MR E11
Answers for life.

MAGNETOM Skyrafit
Operator Manual – MR System
syngo MR E11

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
Used for references and for table or figure titles
Used to identify a link to related information as well as previous or next steps
Used to identify window titles, menu items, function names, buttons, and keys, for
example, the Save button
Used to emphasize particularly important sections of the text
Used for on-screen output of the system including code-related elements or
commands
Identifies inputs you need to provide
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
Italic
Bold
Blue
Courier
Courier
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WARNING
Indicates a hazardous situation which, if not avoided, could result in death or
serious injury.
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
:$51,1*
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1 Introduction 11
1.1 Layout of the operator manual 11
1.2 The current operator manual 11
1.3 Intended use 12
1.4 Authorized operating personnel 13
1.4.1 Definitions of different persons 13
2 Safety 15
2.1 Preface about safety 15
2.1.1 Hazards and risks 15
2.1.2 Common causes of accidents 15
2.1.3 Responsibility 15
2.1.4 Configuration of hazard hints 16
2.2 Common/permanently existing hazards 16
2.2.1 Electromagnetic fields 16
2.2.2 Safety instructions on the static magnetic
field 18
2.2.3 Safety instructions on RF and gradient
fields 20
2.2.4 Contraindications 23
2.2.5 Mechanical hazards 25
2.2.6 Compatibility 28
2.3 What else must be observed? 30
2.3.1 Ambient conditions 30
2.3.2 Access to the examination room 30
2.3.3 Noise development 31
2.3.4 Patient care 32
2.3.5 Artifacts and imaging errors 33
2.3.6 Maintenance/repair 38
2.3.7 Signs and symbols 38
2.3.8 System owner-related advices 41
2.3.9 Coils/quality assurance 41
2.4 In case of emergency 41
2.4.1 Emergency switches 41
2.4.2 Medical emergency 44
2.4.3 Coolant accidents 45
2.4.4 Fire/Fire fighting 46
Table of contents
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3 MR system components 47
3.1 Overview MR system 47
3.1.1 About function 47
3.1.2 Super-conducting magnet 47
3.1.3 Electronics cabinets 47
3.1.4 RF coils 49
3.2 syngo Acquisition Workplace 49
3.2.1 Host 50
3.2.2 Data recording 50
3.2.3 Monitor 50
3.2.4 Keyboard 51
3.2.5 Mouse 52
3.2.6 syngo MR Workplace (optional) 53
3.3 System control 53
3.3.1 Description 53
3.3.2 Operating the Dot display 57
3.4 Patient table 57
3.4.1 Description 57
3.4.2 Operating the patient table 59
3.5 Dockable patient table 64
3.5.1 Description 64
3.5.2 Operating the dockable patient table 65
3.6 Laser light localizer 70
3.6.1 Using the laser light localizer 70
3.7 Alarm box 72
3.7.1 Description 72
3.7.2 Checks 72
3.8 Intercom 74
3.8.1 Description 74
3.8.2 Operating the intercom 75
3.9 In-Room syngo Acquisition Workplace 76
3.9.1 Description 76
3.9.2 Operating the In-Room syngo Acquisition
Workplace 77
3.10 Other components and accessories 80
3.10.1 Gradient supervision 80
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4 Physiological imaging 83
4.1 Triggering methods 83
4.1.1 Prospective triggering 83
4.1.2 Retrospective gating 84
4.2 Physiological Measurement Unit (PMU) 84
4.2.1 Description 84
4.2.2 Preparing the measurement 89
4.3 ECG triggering 91
4.3.1 Description 91
4.3.2 Performing 92
4.4 Pulse triggering 95
4.4.1 Description 95
4.4.2 Performing 95
4.5 Respiratory triggering 96
4.5.1 Description 96
4.5.2 Performing 96
4.6 External triggering 97
4.6.1 Input for external trigger signal 97
4.6.2 Performing 98
5 MR system operation 99
5.1 Daily functionality checks 99
5.1.1 Checking the functionality and
cleanliness 99
5.2 Starting up and shutting down the MR system 100
5.2.1 Starting the system (System On) 101
5.2.2 Shutting down the system (System Off) 103
5.2.3 Shutting down the syngo MR Workplace 104
5.2.4 Starting/ending Standby 105
5.3 Preparing the MR system 105
5.3.1 Connecting the squeeze bulb 106
5.3.2 Setting tunnel conditions 106
5.4 Preparing the patient 106
5.4.1 Informing the patient 107
5.5 Physiological effects 108
5.5.1 Operating modes 108
5.5.2 Exposure to low frequency
electromagnetic fields 110
5.5.3 Exposure to RF electromagnetic fields 112
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5.6 Starting/Stopping the measurement 115
5.6.1 Starting the measurement 115
5.6.2 Stopping the measurement 115
6 Maintenance 117
6.1 Cleaning 117
6.1.1 Cleaning the LCD monitor/video display 117
6.1.2 Cleaning the camera lens 118
6.1.3 Cleaning the data carrier 118
6.1.4 Cleaning the plugs and connectors 118
6.1.5 Cleaning the patient table and the straps 118
6.1.6 Cleaning and disinfecting the receptors 118
6.1.7 Disinfecting system components 119
6.1.8 Care and cleaning of floors 119
6.2 Return and disposal 120
6.2.1 MR System 120
6.2.2 Packaging 120
6.2.3 Batteries and accumulators 120
7 Appendix: regulatory information 123
7.1 Medical devices of other manufacturers 123
7.2 CE for Physiological Measurement Unit (PMU) 124
Table of contents
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Introduction
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.
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.
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.
1
1.1
1.2
Introduction 1
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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.
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!
1.3
1 Introduction
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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.
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.
Definitions of different persons
Term used Explanation
User/Operator/
Operating per-
sonnel
Person who operates the system or software,
takes care of the patient or reads images
Typically physicians, trained radiological techni-
cians, or technologists
System owner Person who is responsible for the MR environ-
ment. This includes legal requirements, emer-
gency plans, employee information and qualifica-
tions, as well as maintenance/repair.
MR worker Person who works within the controlled access
area or MR environment
User/Operator as well as further personnel (for
example, cleaning staff, facility manager, service
personnel)
1.4
1.4.1
Introduction 1
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Term used Explanation
Siemens Serv-
ice/service per-
sonnel
Group of specially trained persons who are
authorized by Siemens to perform certain mainte-
nance activities
References to “Siemens Service” include service
personnel authorized by Siemens.
1 Introduction
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Safety
Preface about safety
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.
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.
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.
2
2.1
2.1.1
2.1.2
2.1.3
Safety 2
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Configuration of hazard hints
All hazard hints are identified in a special way. The following
keywords signal the level of hazard involved:
WARNING Warning regarding risks that may result in
death or serious physical injury.
CAUTION Warning regarding risks that may result in
minor physical injury or material damage.
Example:
WARNING
Source of danger!
Consequences
◆Countermeasure.
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
Electromagnetic fields
In the examination room, there are different kinds of electro-
magnetic fields and the resulting risks.
2.1.4
2.2
2.2.1
2 Safety
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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 18 Safety instructions on the static magnetic field)
Gradient fields Peripheral nerve stimulation
( Page 20 Safety instructions on RF and gradient fields)
RF fields Warming of body tissue
( Page 20 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.
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
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.
Static magnetic field/controlled
access area
Gradient fields
RF fields
Safety 2
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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)
Possible undesirable side effects for MR are dizziness, heating,
claustrophobia and nerve stimulation.
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.
Side effects
2.2.2
2 Safety
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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!
Safety 2
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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).
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.
1Ask the patient to lie still during the measurement.
2Keep 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 3-
Tesla magnetic field!
Reaction of fear by the patient
◆Prior to the examination, inform the patient about the
possible occurrence of these symptoms.
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.
Dizziness during exposure
Device malfunctions
2.2.3
Patients at risk
Current loops and bore wall
contact
2 Safety
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