Nipro TI-SE Instructions D'utilisation page 7

MR LABELING BASED ON THE TEST RESULTS
MR Information. The TWINLINE Catheter (polyurethane with
embedded stainless steel connector) was determined to be
MR-conditional 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, P.O. Box
C700, West Conshohocken, Pennsylvania, 2005.
Non-Clinical testing demostrated that the TWINLINE Catheter
(polyurethane with embedded stainless steel connector) is MR
Conditional. A patient with this device can be scanned safely
immediately after placement under the following conditions:
- Static magnetic field of 3-Tesla or less
- Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MR-Related Heating
In non-clinical testing, the TWINLINE Catheter (polyurethane with
embedded stainless steel connector) produced the following
temperature rise during MR performed for 15-min in the 3-Tesla
(3-Tesla/128-MHZ, Excite, HDx, Software 14X.M5, General
Electric Healthcare, Milwaukee, WI) MR System:
Highest temperature change +1.6°C
Therefore, the MR-related heating experiments for the TWINLINE
Catheter (polyurethane with embedded stainless steel connector) at
3-Tesla using a transmit/receive RF body coil at an MR system
reported whole body averaged SAR of 2.9-W/kg (i.e., associated with
a calorimetry measured whole body averaged value of 2.7-W/kg)
indicated that the greatest amount of heating that occured in
association with these specific conditions was equal to or less than
+1.6°C.
Artifact Information
MR image quality may be compromised if the area of interest is in
the exact same area or relatively close to the position of the
TWINLINE Catheter (polyurethane with embedded stainless steel
connector). Therefore, optimization of MR imaging parameters to
compensate for the presence of this device may be necessary.
Pulse Sequence
Signal Void Size
Plane Orientation
Medcomp WARRANTS THAT THIS PRODUCT WAS MANUFACTURED
®
ACCORDING TO APPLICABLE STANDARDS AND SPECIFICATIONS. PATIENT
CONDITION, CLINICAL TREATEMENT, AND PRODUCT MAINTENANCE MAY
EFFECT THE PERFORMANCE OF THIS PRODUCT. USE OF THIS PRODUCT SHOULD
BE IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED AND AS DIRECTED
BY THE PRESCRIBING PHYSICIAN.
Because of continuing product improvement, prices, specifications, and model
availability are subject to change without notice. Medcomp
its products or contents without notice.
Medcomp is a registered trademark of Medical Components, Inc.
®
StatLock is a registered trademark of C.R. Bard, Inc. or an affiliate
®
MR Safety Information
MR
T1-SE T1-SE
778-mm 233-mm
2
Parallel Perpendicular
WARRANTY
GRE
1,456-mm
2 2
Parallel
-5-
GRE
1,778-mm
2
Perpendicular
reserves the right to modify
®