Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, all single-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton): (1) Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows: screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm, threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws should exclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and with no other screwdriver); (2) Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws; (3) EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solely tightening or loosening the provided screws exclusively, not intended for use with any other screws).
A non-powered, noninvasive component of an electromagnetic surgical tracking system intended to provide a reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure; the EM-tracking diagrams may be subsequently overlaid on radiological images for surgical navigation. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an electrically-powered marker for active registration. This is a single-use device.
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