Intended Use Statement
The MEVION S250 and MEVION S250i are intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation.
Statement of Contraindications (SOC)
Residual Risk Statement
The MEVION S250 and MEVION S250i must only be operated by properly qualified, trained, certified, and experienced personnel. Under no condition may unqualified personnel be permitted to operate this medical device.
Mevion consciously designed and developed the MEVION S250 and MEVION S250i with an intent to minimize the risk of harm to the patient, users, and bystanders associated with use and operation of the MEVION S250 and MEVION S250i. Mevion evaluates hazards, and provide mitigation based on severity and probability of identified risks. Due to the nature of proton beam radiation therapy, residual risks exist during use and operation. Operators must be specifically trained on all equipment, read all instructions, user materials, and customer notices, comply with good clinical practices, exercise due and appropriate care, read and accordingly respond to user warnings and signals, and remain attentive and alert throughout the treatment delivery process.
All forms of radiation therapy may cause side effects, based upon treatment location and prescribed treatment dose. Side effects may include, but are not limited to, hair loss, fatigue, skin irritation, nausea, slow wound healing, respiratory or digestive issues, or irritation to other tissue or organs. Misuse of the product or user error could result in negligible or serious injury, or, in extreme cases, death. Physicians must be adequately qualified, as the ultimate safety and efficacy of the treatment relies upon physician treatment selection, planning, and delivery.
The MEVION S250 and MEVION S250i must be used in accordance with all applicable user, patient, and environmental safety guidelines, laws, and other requirements.