Mri Safety Information - MedComp 14F Split Cath Rg Instrucciones De Uso

MRI LABELING BASED ON THE TEST RESULTS

MRI Safety Information

MR
Non-clinical testing has demonstrated that the 14F Split Cath® Rg catheter/
Extension Assembly is MR Conditional. A patient with this device can be safely
scanned in an MR system meeting the following conditions:
•
Static magnetic field of 1.5 T and 3.0 T only
•
Maximum spatial gradient magnetic field of 4,000-Gauss/cm.
•
Maximum MR system reported, whole body averaged specific absorption rate (SAR)
4 W/kg (First Level Controlled Mode).
Under the scan conditions defined above, the 14F Split Cath® Rg catheter/
Extension Assembly is expected to produce a maximum temperature rise of 2.3ºC
after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends
approximately 20 mm from the 14F Split Cath® Rg catheter/Extension Assembly
when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.
Medcomp WARRANTS THAT THIS PRODUCT WAS MANUFACTURED
®
ACCORDING TO APPLICABLE STANDARDS AND SPECIFICATIONS. PATIENT
CONDITION, CLINICAL TREATMENT, 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
to modify its products or contents in accordance with all relevant regulatory
requirements.
Medcomp and Split Cath
®
References:
1. Zaleski GX, Funaki B, Lorenz JM, Garofalo
RS, Moscatel MA, Rosenblum JD, Leef JA.
Experience with tunneled femoral
hemodialysis catheters. Am J Roentgenol.
1999 Feb;172(2):493-6.
WARRANTY
are
® Rg registered trademarks of Medical Components, Inc.
-10-
reserves the right
®