Siemens MAGNETOM Avanto User manual

www.siemens.com/healthcare
MAGNETOM Avanto,
MAGNETOM Verio
Operator Manual – MR System
syngo MR E11

MAGNETOM Avanto,
MAGNETOM Verio
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
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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 Documentation overview 11
1.1.1 Availability 11
1.1.2 Contents 12
1.2 Accessing the operator manuals on the Internet 13
1.3 Intended use 13
1.4 Authorized operating personnel 14
1.4.1 Definitions of different persons 14
1.5 Information about branding 15
1.5.1 Siemens Healthineers 15
2 Safety 17
2.1 Preface about safety 17
2.1.1 Hazards and risks 17
2.1.2 Common causes of accidents 17
2.1.3 Responsibility 17
2.2 Common/permanently existing hazards 18
2.2.1 Electromagnetic fields 18
2.2.2 Safety instructions on the static magnetic
field 19
2.2.3 Safety instructions on RF and gradient
fields 21
2.2.4 Contraindications 24
2.2.5 Mechanical hazards 26
2.2.6 Compatibility 28
2.3 What else must be observed? 29
2.3.1 Ambient conditions 29
2.3.2 Access to the examination room 30
2.3.3 Noise development 30
2.3.4 Patient care 31
2.3.5 Interventional procedures 33
2.3.6 Artifacts and imaging errors 33
2.3.7 Maintenance/repair 37
2.3.8 Signs and symbols 38
2.3.9 System owner-related advices 40
2.3.10 Coils/quality assurance 41
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2.4 In case of emergency 41
2.4.1 Emergency switches 41
2.4.2 Medical emergency 46
2.4.3 Coolant accidents 46
2.4.4 Fire/Fire fighting 47
3 MR system components 49
3.1 Overview system 49
3.1.1 About function 49
3.1.2 Super-conducting magnet 49
3.1.3 Electronics cabinets 50
3.1.4 RF coils 51
3.2 syngo Acquisition Workplace 52
3.2.1 Host 52
3.2.2 Data recording 52
3.2.3 Monitor 53
3.2.4 Keyboard 53
3.2.5 Mouse 54
3.2.6 syngo MR Workplace (optional) 55
3.3 System control 55
3.3.1 Control units 56
3.3.2 Table display 56
3.4 Patient table 58
3.4.1 Description 58
3.4.2 Operation 61
3.5 Laser-light localizer 65
3.5.1 Using the laser-light localizer 65
3.6 Alarm box 66
3.6.1 Description 66
3.6.2 Checks 67
3.7 Intercom 70
3.7.1 Description 70
3.7.2 Operating the intercom 72
3.8 In-Room syngo Acquisition Workplace 76
3.8.1 Description 76
3.8.2 Operating the In-Room syngo Acquisition
Workplace 77
3.9 Other components and accessories 79
3.9.1 Gradient supervision 79
3.9.2 MagnaCoilTM Headset System 81
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4 Physiological imaging 85
4.1 Triggering methods 85
4.1.1 Prospective triggering 85
4.1.2 Retrospective gating 86
4.2 Physiological Measurement Unit (PMU) 86
4.2.1 Description 86
4.2.2 General operation 93
4.3 ECG triggering 95
4.3.1 Description 95
4.3.2 Performing 97
4.4 Pulse triggering 99
4.4.1 Description 99
4.4.2 Performing 99
4.5 Respiratory triggering 100
4.5.1 Description 100
4.5.2 Performing 100
4.6 External triggering 102
4.6.1 Input for external trigger signal 102
4.6.2 Performing 103
5 MR system operation 105
5.1 Daily functionality checks 105
5.1.1 Checking the functionality and
cleanliness 105
5.2 Starting up and shutting down the MR system 106
5.2.1 Starting the system (System On) 107
5.2.2 Shutting down the system (System Off) 108
5.2.3 Shutting down the syngo MR Workplace 110
5.2.4 Starting/ending Standby 111
5.3 Preparing the MR system 111
5.3.1 Connecting the squeeze bulb and the
headset 111
5.3.2 Setting tunnel conditions 111
5.4 Preparing the patient 113
5.4.1 Informing the patient 113
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5.5 Physiological effects 113
5.5.1 Operating modes 114
5.5.2 SAR: Exposure to RF electromagnetic
fields 116
5.5.3 Stimu: Exposure to low frequency
electromagnetic fields 121
5.6 Starting/Stopping the measurement 122
5.6.1 Starting the measurement 122
5.6.2 Stopping the measurement 123
6 Maintenance 125
6.1 Cleaning 125
6.1.1 Cleaning system components 126
6.1.2 Cleaning accessories 128
6.1.3 Care and cleaning of floors 129
6.2 Return and disposal 130
6.2.1 MR System 130
6.2.2 Packaging 130
6.2.3 Batteries and accumulators 130
7 Appendix: regulatory information 131
7.1 Medical devices of other manufacturers 131
7.2 CE for Physiological Measurement Unit (PMU) 132
7.3 FCC and IC for Physiological Measurement Unit 132
Index 133
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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.
Documentation overview
To improve readability, the Instructions for Use are split up into a
number of individual operator manuals. Each of these individual
operator manuals covers a specific topic or addresses a specific user
group:
◾Hardware components (system, coils, etc.)
◾Software (measurement, evaluation, etc.)
◾System owner manual
The scope of the respective operator manual depends on the system
configuration and may vary.
All components of the complete operator manual may include
safety information that must be adhered to. The intended use of
the system is stated in the operator manual MR System.
Availability
The Instructions for Use are made available mainly in electronic form.
All operator manuals for your system are available online as PDF files
in the Document Library:
1
1.1
1.1.1
Internet
Introduction 1
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◾http://www.siemens.com/MedImaging-Manuals
For detailed information, see: ( Page 13 Accessing the operator
manuals on the Internet)
Additionally, the software-related operator manuals are provided on a
digital medium, for example, CD-ROM or USB flash drive.
The hardware-related operator manuals for your system are provided
in printed form.
Information on frequently-used software functions are also available
context-sensitive in the Online Help. As the Online Help is part of the
software user interface, the language of the Online Help is the same
as the language of the software user interface.
EU Regulations stipulate that every European customer shall be
provided with the option to receive a paper copy of the Instructions
for Use. To comply with this regulation, a voucher is included in the
delivery.
To obtain a printed copy of your Instructions for Use, follow the
instructions on the voucher.
Contents
The operator manuals include information on frequently used
functions for safe and proper use. They may include descriptions
covering standard as well as optional hardware and software. The
description of an option does not infer a legal requirement to provide
it. To find out what hardware and software is available for your
system, contact your Siemens Sales Organization.
The graphics, figures, and medical images used in the documentation
are examples only. Their actual display and design may be slightly
different on your system.
The operator manuals for hardware and software address the
authorized user. Basic knowledge in operating PCs and software is a
prerequisite.
For the sake of simplicity, male and female patients are referred to as
“the patient”.
Other media
Online Help
Customer voucher (European
Union)
1.1.2
1 Introduction
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Accessing the operator manuals on the
Internet
The operator manuals for your system are available electronically on
the Internet.
✓You have the correct name and version of your system (medical
device) at hand.
1In a browser window, enter the following URL:
http://www.siemens.com/MedImaging-Manuals
If you are visiting this site for the first time, you will need to
register and apply for an account.
2Follow the instructions given on the website. After logging on, you
will find further support in the Imaging & Therapy Document
Library help.
3Search and filter for the required document.
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 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.
1.2
1.3
Introduction 1
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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!
Authorized operating personnel
The 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, having received 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 and 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.
1.4
1.4.1
1 Introduction
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Term used Explanation
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)
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.
Information about branding
Siemens Healthineers
Siemens has recently reorganized its organizational group structure.
The healthcare business now is a separate legal entity. This is
manifested in our new brand name:
While we have adopted this new brand name, the legal name of our
company and the name of the Legal Manufacturer do not change.
This change also does not impact any legal obligations. This new
brand name is reflected on newly created product labeling (for
example, user and technical manuals). Already existing material will
not bear the new brand name.
1.5
1.5.1
Introduction 1
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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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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.
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 19 Safety instructions on the static magnetic field)
Gradient fields Peripheral nerve stimulation
( Page 21 Safety instructions on RF and gradient fields)
RF fields Warming of body tissue
( Page 21 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.
2.2
2.2.1
2 Safety
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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
0.5mT. 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.
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 113 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.
Static magnetic field/controlled
access area
Gradient fields
RF fields
Side effects
2.2.2
Safety 2
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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
high field strength. Explain that the forces increase with the
field strength of the magnet!
2Safety
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