RadiaDyne
Essential Product Information (EPI)

Intended Use and Product Information:

The OARtrac® System with patient specific, reusable, precalibrated PSD sensors is intended for use in photon radiation therapy to monitor and validate radiation dose during External Beam Therapy to the surface of the skin or the rectal prostatic interface. This dose verification information obtained during the treatment is then used to compare with the planned dose that the Radiation Oncologists expect to provide to their patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery, but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient’s treatment plan accordingly.

Indication For Use:

The OARtrac® System with patient specific, reusable, precalibrated PSD sensors are intended for use during cancer treatments to measure photon radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body, and indicated for use when adhered to the skin with a bolus, or inserted into the rectum to measure the rectal prostatic interface via a specifically designed endorectal balloon device.

Warnings & Precautions:

  • If the balloon is compromised or damaged during use, the PSD sensor must be discarded and not reused
  • Do not use if there are any outward signs of physical damage to the device
  • Patient injury may result from tampering with the device. Upon suspicion, please contact RadiaDyne® immediately.
  • MR conditional for 3T or less
  • These Instructions For Use apply only to the OARtrac® microPSD Sensor Cable device of the OARtrac® System. For information and applicable warnings on other components of the system, please see the OARtrac® Software Manual, OARtrac® System Manual, & OARtrac® Installation & Maintenance Manual.

Intended Use and Product Information:

The RadiaDyne® ImmobiLoc® Prostate Immobilization Treatment Balloon Device is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during the computed tomography (CT) exam and radiation treatment (RT) therapy. The product is packaged in a kit configuration which includes the following components to perform the procedure: Non-latex Rectal Balloon Device, depth stopper, surgical lubricant, syringe, and instructions for use manual.

Indication For Use:

The RadiaDyne® ImmobiLoc® Prostate Immobilization Treatment Rectal Balloon is a single use, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the rectal wall and adjacent structural anatomies of male patients who require radiation therapy for Prostate Cancer Treatment. The purpose of the device is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation treatments (RT). The placement of the balloon requires a physician or a physician directed health care professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment.

Contraindications:

  • Hemorrhoids
  • Peri-rectal / Peri-anal abscess
  • Anal Fissure
  • Prior low anterior resection
  • Rectal Fistula
  • Rectal Fissure
  • Rectal Ulcer
  • Anal Canal Stricture
  • Diverticulitis
  • Surgery of the prostate, rectum or surrounding area within the last eight weeks Radiation of the rectum or surrounding area within the last eight weeks Any standard exclusionary criteria recognized for endo-rectal / intra-rectal devices

Intended Use and Product Information:

The RadiaDyne® Alatus® Vaginal Balloon Packing System is designed to assist in positioning and displacing of the vaginal wall in a more predictable and reproducible location during the computed tomography (CT) exam and radiation treatment (RT) therapy. The product is packaged in a kit configuration which includes the following components to perform the procedure: Two (2) non-latex vaginal balloons, surgical lubricant, two (2) attachment clips, syringe, chart labels and instructions for use manual.

Indication For Use:

The RadiaDyne® Alatus® Vaginal Balloon Packing System is a single use, non-sterile, disposable,flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Contraindications:

  • Vaginitis
  • Excessive vaginal bleeding
  • Any standard exclusionary criteria recognized for vaginal devices
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