Device Dossier
Radiation therapy treatment planning system, application program software
Device Dossier for Radiation therapy treatment planning system, application program software (Radiation therapy software, Class IIb, sponsor Elekta).…
- GMDN category: Radiation therapy software
Intended purpose
EPIbeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification. The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the presence of the patient and subsequently processes it. The processed data is compared with data calculated by the EPIbeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.