Mri-Related Heating - Integra LifeSciences Codman 82-3048 Mode D'emploi

• The MR system can be operated in either of
the following modes:
Normal Operating Mode (i.e., mode of
o
operation of the MR EQUIPMENT in which
none of the outputs have a value that may
cause physiological stress to PATIENTS)
only with a maximum whole-body-averaged
specific absorption rate of 2.0 W/kg.
First Level Controlled Operating Mode
o
(i.e., mode of operation of the
MR EQUIPMENT in which one or more
outputs reach a value that may cause
physiological stress to PATIENTS that
needs to be controlled by MEDICAL
SUPERVISION) with a whole-body-averaged
specific absorption rate of 4.0 W/kg.
MRI Testing Information
Static Magnetic Field
Translational attraction and torque associated
with a 3 Tesla or lower field strength MR
system are at levels that are less than
those related to gravity and will not pose an
additional hazard or risk to the patient in an
MRI environment at 3 Tesla or less.

MRI-Related Heating

In non-clinical testing, the connector
produced a temperature rise of 0.4°C at a
maximum MR system reported whole-body-
averaged specific absorption rate (SAR) of
3.0 W/kg for 15 minutes of MR scanning
(per pulse sequence) in a 3 T EXCITE
MR Scanner, Software G3 .0-052B, General
Electric Healthcare, Milwaukee, WI, USA.
MRI Artifacts
Artifacts were assessed using T1-weighted
spin echo (SE) and gradient echo (GRE)
pulse sequences. The details of these pulse
sequences and the corresponding artifact
sizes are listed in Table 1. MR image quality
might be compromised if the area of interest
is in the exact location or relatively close to
the location of the connector. However, MRI
artifacts can be minimized by careful selection
of pulse sequence parameters.
Note: The maximum artifact size, as seen on
the gradient echo pulse sequence, extends
approximately 25 mm relative to the size and
shape of the connector.
3
®