Users Manual Part 1

IBA | iv | Clinical User’s Guide
Volume 1 - Treatment Session
Only appropriately qualified personnel may operate the equipment or work in its
vicinity. Qualified personnel are persons familiar with the installation, assembly,
startup, operation, and maintenance of this product, and who possess the relevant
qualifications for their work in accordance with current standards in safety
technology.
Intended Use
The Proteus PLUS is a medical device designed to produce and deliver a proton
beam for the treatment of patients with localized tumors and other conditions
susceptible to treatment by radiation.
The PTS may include a Fixed Small Beam Treatment Room dedicated to treatment
of patients with localized tumors and other conditions susceptible to treatment by
radiation localized in the head and neck.
Indications for Use
The Proteus PLUS is indicated, according to published data, for the following
indications:
 Pediatric tumors
 Medulloblastoma
 Ependymoma, craniopharyngioma
 Rhabdomyosarcoma
 Central Nervous System (CNS) germ cell tumor
 Atypical teratoid rhabdoid
 Glioma
 Skull base chordoma and chondrosarcoma
 Soft tissue sarcoma, osteosarcoma, Ewing’s sarcoma
 Lymphoma (Hodgkin and non-Hodgkin)
 Ocular tumors
CAUTION United States Federal law restricts this device to sale by or on the order
of a physician.