Brand Name or Equal Worksheet ( Salient Characteristics ) v 2.0 ELEKTA LEKSELL STEREOTACTIC SYSTEM (G-FRAME) Essential/significant physical, functional, or performance characteristics. Frame system must have an endoscope guidance adapter System must have a fully integrated micro and macro stimulation positioning function and DBS electrode implantation Implantation must include cross-hairs and A-P holder to verify position System must have a wide range of brain lesion electrodes fully integrated The frame must able to be fixed to the patient s head with 4 adjustable self-tapping screws Stereotactic frame system must use x, y, and z coordinates to localize any point in 3D space A center arc must be employed to target in 3 dimensions Kit must include insulated fixation posts and reusable fixation screws Frame must be able to attach to patient s head by fixation of the coordinate frame with adjustable fixation posts and four self-tapping screws. System must have a sterilizing tray for both frame kit and multi-purpose arc Front of G frame must have front piece titanium screws M4 x 10mm System must have both kits of head frame and arc kit with counter scale Compatibility Frame system must be compatible with Elekta Leksell Neurosurgery accessories and parts for standardization with already owned Elekta Leksell frame system kits. Weight- N/A Industry/Government Standard The Elekta Lesksell Stereotactic system is the Industry/Government standard for stereotactic neurosurgery frames. Purpose This stereostactic system is for use in neurosurgical treatment of targets within the brain. Governing Body or Organization SFVAHCS Other N/A Complete generic identification Stereotactic Neurosurgery Head Frame and Arc system Applicable model/make/catalog number E L E K T A L E K S E L L S T E R E O T A C T I C S Y S T E M ® ( G - F R A M E ) B55309 , B55308 Manufacturer name Elekta Per VAAR 811.104 and 811.105, I certify the following regarding the above information: The salient characteristics listed above are essential to the Government s requirements. To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture. Name, Date: Rogelio Zulueta, OR Administrator 11/28/2018

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