ZOLL IVTM Catheter Quattro - Manual (Page 8)

Quattro
®
Catheter
Instructions for Use
Model IC4593/8700-0660-01
8 of 11
106083-001 Rev 2
MRI Information.
The following models of the ZOLL Heat Exchange Catheters have been determined to be MR-Conditional (formerly classified as
MRI-safe) according to the terminology specified in the American Society for Testing and Materials (ASTM) International,
Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance
Environment. ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005.
1. Cool Line ®
2. Icy ®
3. Quattro ®
Non-clinical testing demonstrated that these catheters are MR Conditional. A patient with this implant can be scanned safely
immediately after placement under the following conditions:
Magnetic Field Interactions
For magnetic field interactions,
-Static magnetic field of 1.5-Tesla or less
-Maximum spatial gradient magnetic field of 2.4 Tesla/meter or less
MRI-Related Heating
In non-clinical testing, these catheters produced the following temperature rises during MRI performed for 20-min in 1.5-Tesla
(1.5-Tesla/64-MHz, General electric Medical Systems, Milwaukee, WI) MR systems, as follows:
Highest temperature change
MRI Condition
+0.6
˚C
1.5-T/64-MHz
Therefore, the MRI-related heating experiments for these catheters at 1.5-Tesla using a transmit/receive RF body coil at MR system
reported whole body averaged SARs of 2.0-W/kg, indicated that the greatest amount of heating that occurred in association with these
specific conditions was equal to or less than 0.6
˚C at 1.5-Tesla.
Artifact Information
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of these catheters.
The artifact size information is, as follows:
Pulse sequence
T1-SE T1-SE GRE GRE
Signal Void Size <1,106-mm 2 <25-mm 2 <1,857-mm 2 <60-mm 2
Imaging Plane parallel perpendicular parallel perpendicular
Therefore, optimization of MR imaging parameters to compensate for the presence of these catheters may be necessary.