MRI Safety - Bard Medical | 合法醫療器材資訊網

MRISafetyTheDenali®VenaCavaFilterwasdeterminedtobe...inthevenacavainthefollowingsituations:•PatientswithanIVCdiameterlargerthan28mm.

MRI Safety The Denali® Vena Cava Filter 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, PO Box C700, West Conshohocken, Pennsylvania, 2005. Non-clinical testing demonstrated that the Denali® Vena Cava Filter is MR Conditional. A patient with this implant can be scanned safely immediately after placement under the following conditions: • Static magnetic field of 3-Tesla or 1.5-Tesla Spatial gradient magnetic field of 720-Gauss/cm or less Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg in the normal operating mode In non-clinical testing, the Denali® Vena Cava Filter produced a temperature rise of 2.7°C at ...