For Clinicians | eIFU Links
Instructions for Use For Healthcare Professionals
You may view or print the Instructions for Use for our brachytherapy and vascular interventions products directly from this site.
Things to Know:
- Instructions for Use for all products may not be available on this site. If you are unable to find an IFU and need assistance, please contact your sales or customer service representative.
- Instructions for Use should be reviewed before using or implanting a device.
- Documents may change without notice. The most current version will be available on this website.
Magnetic Resonance Imaging (MRI): MR Conditional
Non-clinical testing demonstrated that the AgX100 Iodine-125 Device and TheraSeed Palladium-103 Device are MR Conditional. A patient with this device can be scanned safely in an MR system under the following conditions:
• Static magnetic field of 1.5-Tesla or 3-Tesla, only
• Maximum spatial gradient magnetic field of 4,000-Gauss/cm (40-T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the AgX100 Iodine-125 Device and TheraSeed Palladium-103 Device are expected to produce a maximum temperature rise of 1.6˚C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the AgX100 Iodine-125 Device and TheraSeed Palladium-103 Device extends approximately 5-mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.
NOTE: MR Testing did not address mitigation risks associated with MRI scans when seeds are within, adjacent to, or in close proximity with any other implanted devices.
eIFU's for Brachytherapy
