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A patient with the MedStream Programmable Infusion Pump connected to either
the CODMAN Intraspinal Catheter (REF 60-2918) or the SureStream Intraspinal
Catheter (REF 70020) in either a one-piece or two-piece configuration may be
scanned safely under the following conditions and specific guidelines.
Conditions
•
Static magnetic field of 3 Tesla or less.
•
Spatial gradient field of 720 Gauss/cm or less.
•
Maximum whole-body-averaged specific absorption rate (SAR) of 3.0 W/kg for
15 minutes of scanning.
Specific Guidelines
•
Confirmation that cessation of therapy will not negatively impact the patient is
required prior to the MRI exposure.
•
If the cessation of drug therapy will negatively impact the patient but the MRI
procedure is still necessary, an alternate means of temporary drug delivery
with clinical monitoring should be implemented.
•
If there is concern that depriving the patient of drug delivery may be unsafe for
the patient during the MRI procedure, medical supervision should be provided
while the MRI procedure is conducted.
•
The MRI procedure may cause a reset event that will stop the infusion and
elicit an audible alarm or beeping. This reset event does NOT cause loss
of memory data. Upon termination of the MRI procedure, interrogate the
MedStream Programmable Infusion Pump with the MedStream Control Unit to
obtain the pump's current status. If the infusion program has stopped, restart
the program using the MedStream Control Unit.
•
If the physician is unable to restart the pump after an MRI, contact your local
Codman representative.
MRI TESTING INFORMATION
Static Magnetic Field
Translational attraction and torque were assessed at 3 Tesla following guidelines
provided by ASTM 2052-02 and ASTM 2213-06 standards, respectively. Translational
attraction and torque associated with a 3 Tesla or lower field strength MR systems
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
A temperature change equal to or less than 1.9ºC was observed during testing
(parameters listed below). The measured maximum change in temperature
remained below the level of concern indicated by the FDA Guidance for the
6
torso. In the unlikely event that the patient experiences an uncomfortable heating
sensation from the device, the MRI procedure should be stopped immediately and
the scan parameters should be adjusted to reduce the MR system reported whole-
body-averaged SAR to a comfortable level.
Test Parameters:
•
Maximum MR system-report whole-body-averaged SAR of 3.0 W/kg.
•
15-minute duration MR scanning.
®
•
3 Tesla MR system (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 may be compromised if the area
of interest is in the exact location or relatively close to the location of the Medstream
Programmable Infusion Pump. However, MRI artifacts can be minimized by careful
selection of pulse sequence parameters.
Table 1
Summary of MRI Artifact Information
2
Artifact Size (mm
)
28,570
27,849
Pulse Sequence
T1-SE
T1-SE
TR (msec)
500
500
TE (msec)
20
20
Flip Angle
n/a
n/a
Bandwidth (kHz)
16
16
Field of View (cm)
40
40
Matrix Size
256x256
256x256
Section Thickness
10
10
(mm)
Imaging Plane
Parallel
Perpendicular
(long-axis)
(short-axis)
IMPORTANT: For updates on MRI Safety Information, MRI Artifact Information,
Effects of Electromagnetic Interference, contact Codman Customer Service
at 800 660 2660 or +1 508 880 8156, or your Codman Representative.
39,079
40,842
GRE
GRE
100
100
15
15
30°
30°
16
16
40
40
256x256
256x256
10
10
Parallel
Perpendicular
(long-axis)
(short-axis)
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