Intended Use Summary & Important Safety Information

Important Safety Information

Radiation therapy may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary or reproductive systems, fatigue, nausea, skin irritation, and hair loss. In some patients, they can be severe. Treatment sessions may vary in complexity and time. Radiation therapy is not appropriate for all cancers. Patients should discuss the treatment and side effects with their physicians before starting treatment. Individual treatment results may vary. Varian as a medical device manufacturer cannot and does not recommend specific treatment approaches. Medical providers retain the authority to direct all medical decisions regarding the care and treatment of patients.

Product Availability

The products or features presented on this website may not be available for sale in all markets. Their presentation should not be construed as promotion in jurisdictions where authorization to do so has not been granted by law or the applicable regulatory agency.

Intended Use Summary for Linear Accelerators

Varian Medical Systems' linear accelerators are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Safety Statement for Radiation Treatment

Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary or reproductive systems, fatigue, nausea, skin irritation, and hair loss. In some patients, they can be severe. Treatment sessions may vary in complexity and time. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation with your doctor to make sure radiation treatment is right for you. Varian as a medical device manufacturer cannot and does not recommend specific treatment approaches. Individual treatment results may vary.

Safety Statement for Brachytherapy

Radiation treatments may cause side effects varying with the part of the body being treated. This may include, but not be limited to irritation to the mouth, respiratory system, digestive system, genitourinary system, fatigue, nausea, skin irritation, and hair loss. In a minority of patients, side effects can be severe. Typically, the side effects are temporary. Radiation treatment is not appropriate for all cancers. Treatment sessions may vary in complexity and time.

Side effects of applicator placement and/or implantation may occur. These side effects may include, but are not limited to, localized discomfort, bleeding, and infection or other localized side effects based on the location the applicator is placed. Side effects may also occur as a result of procedural anesthesia, and may include, but are not limited to, hypotension, bradycardia, respiratory suppression, airway obstruction, bronchospasm, or decreased oxygen saturation. Patients should discuss the treatment and side effects with their physicians before starting treatment sessions.

Intended Use for Brachytherapy

Varian Medical Systems’ software, afterloaders, and applicators are intended to provide radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Safety Statement for Smart Segmentation

The specific expert cases, commentary, and other information provided here are intended to provide scientific background and informative examples, and are not intended to provide medical advice or an endorsement of any particular radiation contouring or treatment procedure. The radiation oncology healthcare team is solely responsible for deciding whether a patient is a candidate for radiation therapy and how to provide and contour radiation therapy.

Intended Use for Smart Segmentation

Smart Segmentation Knowledge-Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.

Safety Statement for Calypso System

Implanted Beacon transponders may migrate such that they pass from the patient’s body or move to a different location within the body. The most frequent side effects associated with implantation of Beacon transponders are typically temporary and may include, but are not limited to, pain, bleeding, infection. In some patients, these side effects may be serious. Use of the Calypso System and its associated Beacon transponders is not appropriate for all patients. Use of the Surface Beacon transponder for patient setup without correlation to an independent alignment method may lead to patient mis‐localization. You should discuss the potential for side effects and their severity, as well as the benefits of the Calypso System and its associated Beacon transponders with your doctor to make sure it is right for you.

ARIA OIS [from ARIA v11 ISD]

ARIA OIS is designed to assist the oncology staff in managing the patients’ entire course of treatment, approving treatment plans, and performing quality assurance review of the treatment, i.e. to follow-up the delivered treatments and dose to the defined site. The indications for use include any disease or condition treatable with radiation therapy, including but not limited to cancer.

Intended Use for ARIA Practice Management

ARIA Practice Management is a software solution that manages departmental administrative and clinical activities. ARIA Practice Management aggregates information into a complete oncology-specific electronic medical record (EMR) to support medical information management. ARIA Practice Management provides for the scheduling of clinical activities, the capture of patient history information, the ability to document response to treatment, the storage of patient documentation and the capturing of activities for billing purposes.

Safety Statement for ARIA Practice Management

Side effects are related to the treatments delivered independent of our software and must be discussed by the clinician with the patient on a case-by-case basis. Medical providers shall retain the authority to direct all medical decisions regarding the care and treatment of its patients. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Intended Use for ARIA Oncology Information System for Medical Oncology

The ARIA Oncology Information System for Medical Oncology is a software solution that provides the tools needed to manage administrative and financial activities in the medical oncology department. The tools provided by the ARIA Oncology Information System for Medical Oncology software are: Disease Management, Chemotherapy ordering, Drug Ordering, non-drug physician ordering, Pharmacy, Decision Support, Clinical Trials, Health Assessment, Data Collection and Analysis, Charge capture, Report generation.

Safety Statement for ARIA Oncology Information System for Medical Oncology

Intended Use for ARIA Oncology Information System for Radiation Oncology

The ARIA oncology information system for Radiation Oncology is a software solution that manages departmental administrative and clinical activities. ARIA oncology information system for Radiation Oncology aggregates information into a complete oncology-specific electronic medical record to support medical information management. ARIAoncology information system for Radiation Oncology provides for the scheduling of clinical activities, the capture of patient history information, the ability to document response to treatment, the storage of patient documentation and the capturing of activities for billing purposes.

Safety Statement for ARIA Oncology Information System for Radiation Oncology

Intended Use for ARIA Radiation Therapy Management (RTM)

The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIARadiation Therapy Management also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments.

Safety Statement for ARIA Radiation Therapy Management (RTM)

Intended Use for ARIA Oncology Information System (OIS)

The ARIA oncology information system and Radiation Therapy Management product are software solutions that provide the tools needed to manage administrative and financial activities in an oncology department along with treatment and image management associated with chemotherapy and radiotherapy delivery. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Intended Use for Eclipse Treatment Planning System

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for brachytherapy treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Eclipse should only be used by qualified medical professionals.

Safety Statement for Eclipse Treatment Planning System

Specific Product Disclaimers

360 Oncology Care Management Product Disclaimer

360 Oncology care management is not available for sale in all markets and specifications are subject to change without notice. 360 Oncology is not intended to replace clinical decisions, provide medical advice or endorse any particular radiation plan or treatment regimen. The patient’s medical professionals are solely responsible for and must rely on their professional clinical judgment when deciding how to plan and provide treatment. 360 Oncology is not a substitute for customer’s primary data sources and is not for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Safety Statement for ARIA CORE oncology management solution

ARIA CORE is designed to assist the oncology staff in managing the patients’ entire course of treatment, approving treatment plans, and performing quality assurance review of the treatment, i.e. to follow-up the delivered treatments and dose to the defined site. The indications for use include any disease or condition treatable with radiation therapy and systemic therapy, including but not limited to cancer. Side effects are related to the treatments delivered independent of our software and must be discussed by the clinician with the patient on a case-by-case basis. Medical providers shall retain the authority to direct all medical decisions regarding the care and treatment of its patients. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Intended Use Statement for ARIA CORE oncology management solution

The ARIA CORE oncology management solution is a software solution that manages departmental administrative and clinical activities in the radiation therapy department and manage administrative and financial activities in the medical oncology department. ARIA CORE aggregates information into a complete oncology-specific electronic medical record to support medical information management. ARIA CORE provides for the scheduling of clinical activities, the capture of patient history information, the ability to document response to treatment, the storage of patient documentation and the capturing of activities for billing purposes.

Intended Use Statement for ARIA STM

ARIA STM is intended to be used exclusively by healthcare professionals in a clinical setting to facilitate provider treatment management decisions by using treatment management templates defined at the administrative level for patient care and to receive structured data from the ARIA OIS electronic health record and/or manually entered information, perform calculations routinely used in clinical practice, and return informational results to a healthcare professional responsible for cancer treatment.

Safety Statement for ARIA STM

Side effects are related to the treatments delivered independent of our software and must be discussed by the clinician with the patient on a case-by-case basis. Medical providers shall retain the authority to direct all medical decisions regarding the care and treatment of their patients. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Intended Use Statement for ARIA CORE Mobile

ARIA CORE Mobile is intended to be used exclusively by healthcare professionals in a clinical setting to support the review of summarized information from the clinical chart, in order to perform clinical assessments and make clinical decisions, and to support the management of medication information, as well as approval, processing, and administration of care tasks.

InSightive and Qumulate Analytics Software Products Disclaimers

Varian Medical Systems’ analytics software products are for operational and clinical data visualization and are to be used solely for informational purposes. Varian analytics software products are not for use as data or other sources for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

InSightive Product Disclaimer

InSightive analytics is a software tool for the aggregation and display of customer’s information and data maintained within customer’s ARIA oncology information system and is to be used solely for informational purposes. InSightive analytics is not a substitute for customer’s primary data source and is not for use as data or other sources for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Qumulate QA Product Disclaimer

Qumulate QA is a quality assurance tool that allows clinics to visualize, store, and manage their QA machine data. Qumulate QA is not a substitute for customer’s primary data source and is not for use as data or other sources for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Varian Medical Systems is not authorized or qualified to engage in activities that may be construed or deemed to constitute the practice of medicine.

Cryo Product Disclaimer

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology (including cryoanalgesia), dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures, including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Use only as directed. As with all surgical procedures, the possibility of adverse reactions such as pain, fever, chills, sepsis, edema, perforation, ulceration, and hemorrhage may occur.

MTX Product Disclaimer

The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical procedures and in laparoscopic and percutaneous ablation procedures, using image guidance, including partial or complete ablation of nonresectable liver tumors.

The MTX is contraindicated in patients with pacemakers or other active electronic device implants. The MTX is contraindicated in pregnant women as potential risks to the patient and/or fetus have not been established. Use only as directed. Procedural risks may include but are not limited to, pain, infection, and bleeding.

Embolic microspheres

EMBOZENE microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroid (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.

Vascular embolization is a procedure that has inherent risk. The procedure should be performed by specialized physicians experienced in vascular embolization procedures. Risks include but are not limited to: post-embolization syndrome (pain, fever, elevated white blood cell count), vasospasm, vessel trauma (e.g., dissection, perforation, rupture), foreign body reactions (e.g., pain, rash, fever, inflammation), hemorrhage, development of alternative vascular pathways, recanalization, or recurrence of symptoms, infection, allergic reactions, non-target embolization, ischemia at an undesirable location, ischemic infarction, tissue damage, nerve injury, neurological deficits, thrombosis, radiation exposure from fluoroscopy used to visualize the blood vessels during embolization, and/or death.

ONCOZENE microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including hepatoma.

Vascular embolization is a procedure that has inherent risk. The procedure should be performed by specialized physicians experienced in vascular embolization procedures. Risks include, but are not limited to, radiation exposure from fluoroscopy used to visualize the blood vessels during embolization, allergic reactions, tissue damage, complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgement, vasospasm, vessel trauma [e.g., dissection, perforation, rupture]), foreign body reactions (e.g., pain, rash, fever, inflammation), hemorrhage, development of alternative vascular pathways, recanalization with recurrence of symptoms, infection, ischemic infarction, neurological deficits, post-embolization syndrome, non-target vessel thrombosis, and death.

Intended Use Summary & Important Safety Information | Varian