Chapter 2
MRI Safety Information
MR
MR Conditional
Using the CRW ® System in a Magnetic
Resonance Imaging Environment
MRI Safety Information
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MR Unsafe Components
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Non-clinical testing has demonstrated that the Disposable Head Ring Screws
(DHRS), Universal Compact Head Ring Assembly (UCHRA), and Luminant® MR/CT
Localizer (LL01) devices, when assembled, are MR Conditional. A patient with these
devices assembled can be scanned safely under the following conditions:
Static magnetic field of 1.5 T and 3.0
l
Maximum spatial field gradient of 5,000 Gauss/cm (50T/m)
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Maximum MR system reported, whole body averaged specific absorption rate
l
(SAR) of 2.0 W/kg in Normal Operating Mode
Under the scan conditions defined above, the assembled devices (DHRS, UCHRA, LL01)
are expected to produce a maximum temperature rise of less than 6°C after 15 minutes
of continuous scanning.
Caution: The RF heating behavior does not scale with static field strength.
Devices which do not exhibit detectable heating at one field strength may
exhibit high values of localized heating at another field strength.
In non-clinical testing, the image artifact caused by the device extends approximately
1mm from the assembled devices (DHRS, UCHRA, LL01) when imaged with either a
spin-echo or a gradient echo pulse sequence and either a 1.5 T or a 3.0 T MRI system.
Chapter 2 . Using the CRW® System in a Magnetic Resonance Imaging Environment . 8
EN – English
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