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Conditional 8
Conditional 8 – Note: This information pertains to an implant/device that has MRI labeling at 1.5-Tesla and 3-Tesla, only.

The implant/device was determined to be MR Conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Non-clinical testing demonstrated that the implant/device is MR Conditional. A patient with this implant/device can be scanned safely immediately after placement under the following conditions:
• Static magnetic field of 1.5-Tesla and 3-Tesla, only
• Maximum spatial gradient magnetic field of 720-gauss/cm (a higher spatial gradient magnetic field value may apply if properly calculated)
• Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg (i.e., the Normal Operating Mode) for 15 minutes of scanning (per pulse sequence)

MRI-Related Heating
In non-clinical testing, the implant/device produced the following temperature rises during MRI performed for 15-minutes (i.e. per pulse sequence) in 1.5-Tesla and 3-Tesla MR systems, using an MR system reported, whole body averaged SAR of 2-W/kg or less, as follows:
Highest temperature changes
Less than or equal to 6.0 degrees C at 1.5-T/64-MHz
Less than or equal to 6.0 degrees C at 3-T/128-MHz

Artifact
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant/device. In some cases, the artifact size relative to the size of the implant or device may be indicated.

Attention: Contact the manufacturer of this implant/device for further information.


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