M708348B771 Rev A
2017-10-15
ARTiC-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti
Spinal Systems
MRI Safety Information
IMPORTANT INF ORMATION ON THE ARTiC-L™ 3D Ti Spinal System and ARTiC-XL ™ 3D Ti
Spinal System
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
MR Conditional
In non-clinical testing, the ART i C-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti Spinal System were
determined to be MR Conditional. A patient with these devices can be safely scanned immediately after
device placement under the following conditions:
Static Magnetic Field
• Static magnetic field of 1.5 Tesla and 3 Tesla.
• Maximum spatial gradient magnetic field of 3000 Gauss/cm (30 T/m) or less
• Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg under Normal operating
mode for 15 minutes of scanning per pulse sequence.
MRI-Related Heating
Under the scan conditions defined above, the ARTiC-L™ and ARTiC-XL™ 3D Ti Spinal Systems were
expected to produce a maximum temperature rise of less than 5.0°C after 15 minutes of continuous
scanning.
Artifact Information
In non-clinical testing, the image artifact caused by the device extends approximately 13 mm for a spin
echo sequence and 23 mm for a gradient echo sequence in a 3 Tesla MR system. Therefore, optimization of
MR imaging parameters to compensate for the presence of these devices may be necessary.
If the ARTiC-L™ 3D Ti Spinal System and ART iC-XL™ 3D Ti Spinal System are used in connection
with any device which is not MR Conditional, be advised this combination has not been tested in the MR
environment and, therefore, highe r heating and possible injury to the patient may occur.
The presence of other implants or the health state of the patient may require a modification of the MR
conditions.
Further Information
See the device-specific package insert for a complete listing of indications, contraindications, warnings,
and precautions.
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