36C26119Q0399-000.docx

ELEKTA LEKSELL STEREOTACTIC SYSTEM (G-FRAME)

1) 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

a) Compatibility – Frame system must be compatible with Elekta Leksell Neurosurgery accessories and parts for standardization with already owned Elekta Leksell frame system kits.

b) Weight- N/A

c) Industry/Government Standard – The Elekta Lesksell Stereotactic system is the Industry/Government standard for stereotactic neurosurgery frames.

d) Purpose – This stereostactic system is for use in neurosurgical treatment of targets within the brain.

e) Governing Body or Organization – SFVAHCS

f) Other – N/A

2) Complete generic identification – Stereotactic Neurosurgery Head Frame and Arc system

3) 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

4) 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

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

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* = Required Field FedBizOpps Presolicitation Notice Rev. March 2010 Elekta Leksell StereoTactic System with Head Frame 95652-2609 36C26119Q0399 03-21-2019 N 334510 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 3230 Peacekeeper Way, Bldg 209 McClellan CA 95652-2609

SFVAMC

4150 Clement St San Francisco, CA 94121 United States www.sanfrancisco.va.gov San Francisco VA Medical Center image1.emf image2.emf image3.emf image4.emf image5.emf