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The MR Section of The National Electrical ManufacturersAs- THIS DOCUMENT IS intended to address considera-
sociation (NEMA). in response to a request from the Food & tions with regard to the design and testing of third
Drug Administration (FDA),recently issued a position paper party equipment for use with a n MR system. It also
to address generic issues related to the compatibility of ac- provides information that may be of use to the end user
cessory equipment produced by third party equipment man-
ufacturers or MR equipment users and intended to be used
of that equipment. The information provided herein is
in conjunction with MR equipment or within the MR scan- generic with respect to MRI systems. Designers of third
ning room. The recommendations concern scanning acces- party equipment for use with MR systems, and users
sories, such as radiofrequency (RF) coils, patient monitoring of MR equipment building their own coils and acces-
equipment and injectors, as well as patient comfort acces- sories, should be aware that MR is a n evolving tech-
sories and positioning devices. The following issues related nology and specifications and performance
to safety performance are discussed (a)the interaction of characteristics of specific MR systems continually
the equipment with the MR scanner, (b) interactions of the change. Products from third party sources should be
MR scanner with the equipment, and (c)potential safety haz- tested under simulated or actual conditions of use. Be-
ards for patients and staff that can be posed by accessory cause upgrades to the MR system to achieve higher
equipment in the MR scan environment. The recommenda-
tions are based on combined input from NEMA member com- performance levels may affect the characteristics of the
panies who manufacture MR systems and MR accessories equipment, manufacturers of accessory devices are ad-
and are presented for consideration in the design of MR ac- vised that today's testing may not be sufficient to en-
cessory products and incorporation of these concepts into sure the safety and effectiveness of their device with
testing plans to ensure MR compatibility of third party de- tomorrow's MR system.
vices. Additional information with regard to system-specificre-
Index terms: MR compatibility - M K safety. MK equipment quirements should be obtained directly from the MR mar-
ufacturer.
JMRJ 1998: &:12-18
DeBnition of M R Compatibility
Abbreviations: CHT = cathode ray tube. DC = direct current. EMC = electromag- A device can be considered a s MR compatible if it can
netic compatil,ility. FDA = Fond & Drug Administration. LCD :. liquid crystal display. be used safely, a s indicated, within the MR scan room
LED = light r'mitting diode. NEMA = National Electncal Manufiicturers Association.
OE:M = original equipment m;iriulacturer. RF = radiolrequency. SAR = sperifir ab-
and during the scan procedure without adversely affect-
soiption rat<' T/R = transmitJrrceive. ing the performance of either the MR system or the device
itself. A device may be MR compatible for certain types of
uses but not for others. The device labeling must clearly
and explicitly define the conditions for safe and effective
use.
Scope
The document covers the following areas: (a)interac-
tion of the equipment with the MR system, (b)interaction
of the MR system with the equipment, (c) potential safety
hazards resulting from the use of the equipment in an
MR scanning environment, (d) special considerations for
surface coils, insert gradient coils, and cervical fixation
devices.
It provides guidance that is intended for use during the
initial design and subsequent installation of accessory
equipment obtained from third parties. Third party
equipment is that produced by someone other than an
original equipment manufacturer (OEM) of MR systems
From I he Maqnetic Resonance Section, Diagnostic Imaging and ThPrapy Systems Di- and intended for use a s an accessory in the MR environ-
vision. Na1ioii.il Electrical Manufacturers Association. 1300 Norlh 17th Street. Suite ment.
1847. K o s s l ~ nVA 22209. E-mail ekkQmr.pirker.com. Received September 19. 1996: Because the number of possible devices that could be
revision rrqiirsted May 20. 1997: accepted May 28. Presented a t the Workshop on
Advances in MR Safety and Compatibility. Macinan. VA. June $1-1 1. 1996. Address
useful accessories to MR scanners is very large and the
reprint requests t o E K.K. at Picker International. 595 Miner Road. Cleveland. OH number actually used in the MR environment grows
44143. daily, we have chosen those in most common use as ex-
ISMRM. l < l Y 4 amples to illustrate the variety of interactions that are of
12
concern. These include pulse oximeters, ECG monitors, through the patient interface connections (ECG leads or
respirators, anesthetic apparatus, contrast injectors, and pulse pickup) into the imaging area.
infusion pumps. It also includes scanning accessories To prevent this RF interference from degrading the MR
such as surface coils and patient positioning devices and image, appropriate measures should be used to provide
patient comfort systems such a s audio and video devices. RF shielding, such a s housing the display in a n RF tight
Although implanted metallic, electronic, or mechanical enclosure or locating the unit outside the RF room. In
devices a s well a s surgical intervention devices are not either case, the connections between the display unit and
explicitly included in this document, the principles stated the patient interface should pass through low pass filters
herein can be applied to such devices with appropriate that significantly attenuate (minimum of - 100 dB) fre-
attention being paid to the unique circumstances being quencies around the Larmor frequency of the MR system
set up by the devices proximity to specific tissue. (eg, 21.3 MHz for a 0.5T magnet, or 64 MHz for a 1.5-T
magnet). For patient contact devices, such a s ECG mon-
0 THE MR ENVIRONMENT itors, safety guidelines for patient isolation and leakage
The MR environment is the term used to describe the currents must be ensured per the requirements of IEC
general environment in the vicinity of the MR scanner (ie, 60 1- 1.2
Sensors and detectors such as those used in pulse
magnet). It includes the region from the center of the
oximetry equipment contain a n additional interference
magnet bore out to the 5-G line (.0005 T). Beyond the 5-G
line. the levels of magnetic field are generally considered source. Pulse oximeters measure the absorption ratio of
to be safe, although some effect may still be produced a red LED and infrared LED to determine the patients
on devices such as cathode ray tube (CRT) displays and pulse and blood saturated oxygen content. Units that cy-
image intensifiers. cle the LEDS on and off at a rate of several kilohertz can
be a source of radiated RF interference, which can be
picked up easily by the MR receive coil and result in de-
Characteristics of the M R Environment graded image quality, because the sensor is located very
The MR environment is characterized by the following: near the receiving coil of the MR system. Shielding of the
1. The static magnetic field (most commonly in the range sensor is recommended to prevent this noise from reach-
of .2to 2.0 T, although field strengths a s low a s .06 T ing the MR system.
and greater than 4 T are also in use) and the associ- Similar RF considerations should be made in the selec-
ated spatial field gradient. tion of patient audio and video equipment. The tape deck,
2. The rapidly changing magnetic fields (gradients)that tuner, or CD player for a patient audio system usually is
are used during imaging (- 1 Hz). located near the operators console and a speaker or
3. Radiofrequency (RF) pulses (on the order of tens to headphone set is located within the scan room. MR man-
hundreds of MHz). ufacturers require that signals between the audio equip-
ment and the speaker must penetrate the RF room
0 INTERACTION OF EQUIPMENT WITH THE MR through appropriate filters or make use of a nonelectri-
SYSTEM cally conducting medium, eg, fiber optics or infrared
External equipment can interact with the MR system transmission, to prevent RF interference outside the
either through the generation of R F interference or dis- room from being conducted into the MRI environment.
turbance of the homogeneity of the magnetic field. Either Specific information about these requirements can be ob-
of these may adversely affect scanner performance and tained from the Siting Guides, available from most OEM
reduce its diagnostic effectiveness. MR system manufacturers.
Simple solutions may not be available with video equip-
RF Interference Considerations ment such as patient TV. As with audio equipment, con-
In general, third party equipment should be designed trol signals must be filtered at the RF room wall.
to meet the requirements of IEC 601-1-2. This standard Additionally, consideration must be given to the interfer-
defines field levels for RF emissions and electromagnetic ing frequencies that could be generated by the TV display
compatibility (EMC).Related standards and tests can be itself. If a flat panel display is used, it should be properly
found in CISPR- 11 and IEC 80 1- 1 through 4. It should enclosed and RF should be shielded to prevent interfer-
be noted that none of the current standards are specifi- ence with the MR system.
cally concerned with MR compatibility and additional
steps actually are required. Some general guidance re- Magnetic Field Considerations
lated to design practices for MRI accessories is given be- Significant masses of ferromagnetic material in prox-
low. imity to the magnet can disturb the homogeneity of the
If RF shielding is inadequate, equipment that includes static MR magnetic field. Distorted images could result if
display screens and/or microprocessors, such a s patient the homogeneity of the main magnetic field is degraded
monitoring equipment, may produce RF interference that significantly (1). Respirators and anesthesia equipment,
affects image quality. Interference sources include micro- carts, or gas cylinders should be designed to use nonfer-
processor clocks and displays that can generate a wide romagnetic materials. Patient monitoring equipment lo-
range of frequencies. Light emitting diode (LED), liquid cated within the scan room also could have an effect on
crystal display (LCD),or CRT displays and indicators may the magnetic field homogeneity. Power supply transform-
appear visibly steady but are, in reality, being electrically ers or the frame of the unit could contain sufficient mag-
turned on and off at a high frequency a s a requirement netic material to result in a distortion of the field.
of the display technology or to conserve power. The re- Other conductive, but nonferromagnetic, materials
sulting clock and display interference can be radiated di- may exhibit induced RF currents that can lead to image
rectly into the RF room environment or conducted distortion. Artifacts caused by nonferromagnetic materi-
These documents can be obtained from the ANSI Sales Office. 1 I West 42nd Street, This document can be obtained from the ANSI Sales Oflice. 1 1 West 42nd Strert
New York. NY 10036. (212) 642-4900 New York. NY 10036. (212) 642-4900