fgp_Sinus_SuperFlex_535

Sinus SuperFlex 535

Peripheral Stent

Optimed

Fabrikat/model

Sinus SuperFlex 535

Peripheral stent

Optimed

Bemærk

Atypisk IFU fra producenten...


A scientific investigation [1, 2] demonstrated that implant/ device made out of nitinol and/or tantalum are MR Conditional. A patient with this implant/device can be scanned safely immediately after placement under the following conditions...


l Static magnetic field of 3.0-Tesla or less


Kommentar

Man må således antage, at der fra producentes side ikke er udstukket begrænsende restriktioner i forhold til såvel maksimale spatiale gradienter samt til maksimal WB-SAR.

Bemærk

Producenten har noteret følgende i IFU...

The effect of heating in the MRI environment for overlapping stents is not known.

Statisk feltstyrke

Maksimalt 3,0 Tesla

Spatial gradient

Ikke specifikt oplyst - Formentlig ingen restriktioner...

Slew rate (Gr)

Ikke oplyst

SAR

Producenten har noteret følgende i IFU...


In non-clinical testing, the implant/ device produced the following temperature rises when MRI was performed for 3 min at 1.5 Tesla. (Intera, Philips Medical Systems (PMS), Software 12.6.1.4) and performed for 15 min. at 3 Tesla (Signa Hdxt, General Electric (GE). Medical Systems, Software 15.0_M4_0910.a) and at an average whole-body SAR of 3 W/kg registered by the MRI system.


Anbefaling, grundet uklar IFU: Max WB-SAR - 2 W/kg (normal operating mode)

B1+rms

Ikke oplyst

Coil type

Ikke oplyst

Artefakter

Må kunne forventes

Temperaturstigning

Producenten har noteret følgende i IFU...


Highest temperature change MRI Condition
     - l Less than or equal to 4.0 degrees C at 1.5-Tesla
     - l Less than or equal to 4.0 degrees C at 3.0-Tesla

Kilde

IFU fra producenten - Reference: 1161_001

Gyldighed

Denne procedure kan anvendes som inspirationskilde til udvikling af egne sikkerhedsforskrifter

Information

Procedure 1161. Revision: 1.8

Udarbejdet af: Bo Haugaard Jørgensen

Dato: 02.12.2023

Opdateres: Løbende, senest 01.01.2025