Integra LifeSciences Codman RICKHAM Manual página 5

Magnetic Resonance Imaging (MRI) Information
The HOLTER Ventriculostomy Reservoir Sets listed below have no
materials that are metallic or conducting and, therefore, are "MR
Safe" in accordance with the American Society for Testing and
Materials (ASTM) Standard F2503.
82-1615
82-1616
82-1617
Non-clinical testing has demonstrated that the HOLTER
Ventriculostomy Reservoir Sets listed below are considered "MR
Conditional" in accordance with ASTM F2503 and they can be
scanned safely under the following conditions at any time after
implantation:
82-1621
82-1623
82-1625
Conditions
• Static magnetic field of 3 Tesla or less.
• Spatial gradient field of 720 Gauss/cm or less.
• The MR system can be operated in either of the following modes:
o Normal Operating Mode (i.e., mode of 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.
o First Level Controlled Operating Mode (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 HOLTER Ventriculostomy Reservoir Sets
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
RICKHAM design, nylon and silicone
Large RICKHAM design, nylon and silicone
SALMON-RICKHAM design, nylon and silicone
RICKHAM design, stainless steel
Large RICKHAM design, stainless steel
SALMON-RICKHAM design, stainless steel
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