Siemens MAGNETOM syngo MR D11 User manual

www.siemens.com/healthcare
MAGNETOM Family,
Biograph mMR
Operator Manual – MR Elastography
syngo MR D11, syngo MR D13, syngo MR B19,
syngo MR B20P, syngo MR E11

MAGNETOM Family,
Biograph mMR
Operator Manual – MR Elastography
syngo MR D11, syngo MR D13, syngo MR B19,
syngo MR B20P, 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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Legend
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1 Introduction 9
1.1 Information about branding 9
1.1.1 Siemens Healthineers 9
2 Safety information 11
2.1 General 11
2.2 Handling of hardware components 11
2.3 Compatibility 13
2.3.1 Labeling 14
3 Description 17
3.1 Hardware components 17
3.1.1 Trigger converter box 17
3.1.2 Active driver 18
3.1.3 Passive driver 18
3.1.4 Additional components 18
3.2 Software application 19
3.2.1 Image acquisition 19
3.2.2 Image evaluation 19
4 Configuration 21
5 Preparation 25
6 Examination 27
6.1 Scope 27
6.2 Performing the measurement 27
6.3 Viewing the results 28
7 Maintenance of hardware components 31
7.1 Cleaning 31
7.2 Storing 31
7.3 Disposal 31
8 Technical data 33
8.1 Technical data of the Resoundant components 33
Table of contents
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9 Appendix: regulatory information 35
9.1 Medical devices of other manufacturers 35
Table of contents
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Introduction
This operator manual is an addendum to the operator manual MR
system, respectively MR-PET system.
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 appearance and design of
these may be slightly different on your system.
References to “Siemens Service” include service personnel authorized
by Siemens.
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.
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:
1
1.1
1.1.1
Introduction 1
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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 Introduction
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Safety information
General
All safety information of the valid operator manuals must be
adhered to without fail. It is merely supplemented by the notes
contained herein.
All personnel should be instructed in the proper connection, use and
handling of the system.
Always follow proper safety, operating and maintenance
procedures to prevent exposure to electrical or mechanical
hazards that may cause injury.
Handling of hardware components
WARNING
Improper handling of system components!
Serious injury to patient and operator
System components may not function correctly
◆Use all components of the system with care. Visually check
the components of the system before each use, do not use
the components if there is any visual damage.
◆Do not use the components of the system in the presence of
flammable anesthetics in combination with air, oxygen or
nitrous oxide.
◆Avoid contact with water as the equipment is not protected
against the ingress of water.
2
2.1
2.2
Safety information 2
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CAUTION
Active driver is not properly configured!
Wrong diagnosis
◆Ensure that the active driver is configured correctly as
described in the configuration setup (see chapter
configuration).
CAUTION
Use of unapproved accessories or cables!
Electromagnetic interference may lead to incorrect
operation of the equipment
◆Only use accessories and cables that are provided by
Resoundant.
- or -
Consult Resoundant if other cables need to be used.
WARNING
Improper storage of driver components!
Serious injury due to projectile accidents
Driver components may not function correctly
◆Never place the active driver component of the system in the
examination room.
◆Store the active driver component in an air-conditioned
equipment room.
◆Store the passive driver component of the system in the
examination room.
2Safety information
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WARNING
Improper operating, servicing, and/or cleaning of the system
components!
Serious injury to patient and operator
System components may be damaged
◆Ensure that the operator is properly trained and observes all
safety information.
◆Ensure that the system is not modified, and only serviced by
trained service representatives.
◆Do not attempt to clean the components while attached to
main power. Unplug the components from main power
before cleaning them.
◆Never place the components of the system in any type of
sterilizer.
◆Follow the instructions on cleaning, storage and disposal
stated in this manual.
◆If any part of the component becomes contaminated by
human body fluids, dispose of it in accordance with local
regulations.
Installation and configuration of the trigger converter box must
only be performed by Siemens Service.
Compatibility
For the MR Elastography components, the following classifications
apply:
2.3
Safety information 2
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Trigger converter
box
Active driver
Passive driver
Labeling
ASTM International developed a new classification system for
implants and ancillary clinical devices. The following definitions
apply:
MR Safe An item that poses no known hazards in all MR environments. MR Safe items
include nonconducting, nonmagnetic items such as a plastic petri dish. An
item may be determined to be MR Safe by providing a scientifically based
rationale rather than test data.
MR Conditional An item that has been demonstrated to pose no known hazards in a specified
MR environment with specified conditions of use. Field conditions that define
the specified MR environment include field strength, spatial gradient, dB/dt
(time rate of change of the magnetic field), RF fields, and SAR. Additional
conditions, including specific configurations of the item, may be required.
MR Conditional devices (for example, RF communications equipment) may
present hazards as well. Please observe the manufacturer's operator manual
to avoid potential hazards and injuries.
2.3.1
2 Safety information
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MR Unsafe An item that is known to pose hazards in all MR environments. MR Unsafe
items include magnetic items such as a pair of ferromagnetic scissors.
If in any doubt contact the vendor and do not place the component
inside the magnetic field.
Contact Siemens for a complete list of MR Safe Siemens products.
Safety information 2
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2 Safety information
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Description
Hardware components
The hardware components of the MR Elastography option create,
conduct and introduce pressure waves into the human body. They are
designed to be used in conjunction with imaging systems.
There are three specific components of the MR Elastography option:
Equipment room (A), examination room (B)
(1) Trigger converter box
(2) Active driver
(3) Passive driver
The active driver and the passive driver are third-party products and
part of the Resoundant acoustic driver system. A complete list of the
Resoundant hardware components is contained in the Resoundant
user manual, which is supplied with the hardware package.
Trigger converter box
The trigger converter box is located next to the active driver in the
equipment room. It is configured by Siemens Service. It receives input
from the scanner electronics and triggers the active driver.
The trigger converter box is MR Unsafe.
3
3.1
3.1.1
Description 3
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Active driver
The active driver is located in the equipment room. The active driver
is triggered by the trigger converter box and creates pressure waves.
The pressure waves are transferred to the passive driver via plastic
tubing.
If the active driver is on, but not triggered by the trigger
converter box for longer than 1.5 hours, the active driver will
enter a low-power sleep mode. Triggers from the MR system will
not wake the unit automatically - the active driver has to be
switched off and on again to function.
The front panel of the active driver includes a green LED for Power.
Systems manufactured after April 2018 also include a blue LED to
indicate Awake (ready to output acoustic energy).
The active driver is MR Unsafe.
Passive driver
The passive driver is placed on the patient’s body and secured with a
belt. It is connected to the plastic tubing coming from the active
driver via a connector.
The passive driver applies the pressure waves received from the
active driver to the patient’s body.
The passive driver is MR Safe. The passive driver is not in patient
contact. See also example image: Chapter "Preparation".
Additional components
The following components are also included:
◾Long and short plastic tubing for pressure wave transfer from
active to passive driver
◾Belt for securing the passive driver
◾Cords and cables for connecting the trigger converter box with the
active driver and the components with the scanner electronics
3.1.2
3.1.3
3.1.4
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Only approved replacement parts must be used. Any changes or
modifications to the components directly connected to the
scanner (for example, trigger converter box) must be approved
by Siemens.
Software application
The software application of the MR Elastography option monitors the
propagation of the pressure waves in the human tissue.
Image acquisition
The following protocols are available for MR Elastography
acquisitions:
◾greMRE_tra_bh: a single slice can be acquired in a 28 s breathhold
◾greMRE_tra_p2_bh: for noncompliant patients requiring a shorter
breath-hold time, a single slice can be acquired in a 22 s
breathhold
Image evaluation
For post-processing, the software displays the wave propagation and
generates relative stiffness maps.
The following result images are generated:
◾Magnitude
◾Relative stiffness
◾Relative stiffness 95%
◾Wave
◾Phase Difference
◾Confidence
For more information, see ( Page 27 Examination)
3.2
3.2.1
3.2.2
Description 3
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3 Description
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