6515--Leksell Vantage Stereotactic Instruments Brand name or Equal to This is not a request for quotes

Page 1 of Page 6 of 51 Page 1 of Statement of Need The Corporal Michael J. Crescenz VA Medical Center requires additional components for the Leksell stereotactic system specifically to enhance the capabilities for performing Deep Brain Stimulation (DBS) procedures at our facility. Background Deep Brain Stimulation (DBS) is a recognized treatment for various neurological conditions, including Parkinson s disease, essential tremor, and dystonia. The procedure involves implanting electrodes within certain areas of the brain to produce electrical impulses that regulate abnormal impulses or affect certain cells and chemicals within the brain. CMC VAMC uses the Leksell stereotactic system for precise navigation and targeting during these intricate procedures. While the existing system provides a solid foundation, certain components must always have back-ups to maintain the highest standards of care, improve outcome accuracy, and expand the procedural capabilities in line with modern advancements in DBS. The procurement and integration of these additional back-up components will have a profound impact on our service- delivery. Salient Characteristics/ Compatibility Requirements: Brand Name or Equal
Needs to be compatible with current Alpha Omega s Neuro Omega platform for Deep Brain Stimulation (DBS)
Accuracy must be within 1 micron (.001 mm).
Must filter, amplify, and digitize signals from the brain up to a foot away from patient head.
Must minimize electromagnetic interference and other types of interference in the room Must be shielded with Tungsten or other equivalent material
Must also measure Local Field potentials from each micro electrode on the implanted lead
Must include Sterilization tray for Drive Headstage and Cable ECoG HeadBox HeadBox Cable HeadBox Holder Transformer Recording Only
Drive and recording HeadStage must be one single assembly with electronic drive HeadStage must measure ECoG, EMG, EEG, and other electric signals from the body with up to 16 channels. 10 Channels must be able to record unfiltered raw, high frequency spike and low frequency LFP signals. There must be an ability to expand the amount of channels Must allow for trajectory adjustments without frame manipulation
Must Drive up to 5 micro electrodes simultaneously
Must utilize broadband filtering
Only 1 cable shall be utilized to connect headstage to Neuro Omega No adaptors or connectors can be used
HeadStage Drive and Cable must meet Robert Koch Institute recommendations for cleaning and sterilization of medical devices
Must be usable with or without Stereotactic Frames
Must be compatible with the following systems at a minimum
Rosa ONE Brain Leksel Frame
Must allow for implantation of DBS Electrode without altering the position of the drive or removing cannulas.
Example Brand Name or Equal Schedule
1040051Leksell Vantage Key 1EA An instrument screw driver used with Leksell Vantage Stereotactic Arc System as well as with FirmFix pins during Leksell Vantage Head Frame Fixation. Index bits Hex 3 and 4 are made of titanium while the rest of the Leksell Vantage Key is made of aluminum. 1040025 Leksell Vantage Cross-Hairs 1EA Leksell Vantage Cross-Hairs Kit in Stainless Steel is used with Leksell Vantage Stereotactic System to intraoperatively check the placement of inserted electrodes, catheters or other instruments in relation to the set target point. The cross-hair has two parts. The cross plate has a thin pattern of a cross and the ring plate has a thin pattern of concentric rings. This difference makes it easy to find the line of sight in the X-ray images. Both the ring plate and the cross plate are equipped with rubber O-rings that ensure secure attachment to the rings of the arc. The cross-hairs is MR Unsafe. 1040036 Leksell Vantage Head Frame 1EA This design of the head frame gives an open space in front of the face area. Therefore, it gives space for intubation of the patient if necessary in an emergency situation. The frame is MR Safe. The frame is designed for head sizes between 49 and 62 cm in circumference. The head width can be 134-175 mm in range and length 167-215 mm in range. The Leksell Vantage Key is used for FirmFix pin head frame fixation and for Leksell Vantage Stereotactic Arc target coordinate settings. 2 x Leksell Vantage Keys are included. 1040048 Leksell Vantage Arc System 1EA Leksell Vantage Arc System is designed to allow the surgeon to select any desired trajectory to the predetermined target, regardless of the patient"s position, when using together with Leksell Vantage Head Frame. It is used for diagnostic and therapeutic procedures, such as functional interventions and minimal invasive neurosurgical procedures within its intended use. The arc system is MR Conditional. 1040045 Leksell Vantage Arc Tray 1EA The sterilization tray is used for the sterilization procedure of the parts of the Leksell Vantage Arc System, Leksell Vantage Key and Leksell Vantage Arc Cross-Hairs. 1040093 Vantage Starburst 3/8 1EA Includes the Starburst interface for operating table base units with 3/8 screw interface, the starburst screw, and allen key 6 mm that are used to fix the starburst to the Leksell Vantage Frame Holder. 1040114 Leksell Vantage Frame Holder 1EA Holds the Leksell Vantage Head Frame in position when interfacing to operating tables and diagnostic CT scanner tables. It is used in the operating theatre together with Starburst interfaces. It is also used during CT imaging where it is attached to the Leksell Vantage Frame Holder Extension. 1556500 EN/Leksell Vantage/QRG 1EA
1569126 EN/LVSS ARC System/QRG 1EA
1572849 EN-US/ Leksell Vantage System /IFU
1EA

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