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...
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 |
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 |
