The Department of Veterans Affairs is seeking a vendor to provide a robotic surgical equipment system and software solution for brain surgery. The system must be compatible with VA TRM, VA SAAS, and DICOM. The vendor will be responsible for installation, training, and maintenance of the system. The contract will be for a period of up to 1 year. Key features of the system include: image-guided robotic stereotactic equipment, software for neurosurgical and ENT procedures, and a touch screen display. The vendor must provide a firm fixed price for the system, including all necessary accessories and software.
Some of the key requirements for the system include:
* Technically equivalent to a complete robotic brain surgery system
* Must have an alignment software updates compliant with VA TRM, VA SAAS, DICOM
* Indicated use for neurosurgical and ENT procedures
* Includes mobile wheeled touch display cart, infrared camera cart, and touch screen at least 32” for easy control and clear visualization
* Includes 4k resolution or better for clear visualization
* Includes display drape and integrated laser pointer
* Includes non-invasive battery-powered, quick, touchless, and markerless patient registration wireless laser pointer
* Includes storage box for registration accessories and navigation pointer for image-guided neuro- and ENT surgery
* Includes safe storage tray and efficient steam sterilization (autoclaving) of standard cranial accessories
* Includes OIT VA TRM compliant data management software compatible with Optum, VISTA, and Cerner
* Includes image viewing, manipulation, and data enrichment software specifically developed for surgeons
* Includes image fusion capabilities to exploit all anatomical & functional data sets simultaneously
* Includes intuitive and interactive 3D contouring tool for outlining of pathologies and anatomical structures in medical images
* Includes software platform to map complex paths by integrating target deep-brain structures with patient-specific vascular and functional maps for multiple trajectories for neurosurgical approaches
* Includes software spatial mapping is a primary requirement for frameless stereotaxy and surgical navigation to ensure the pinpoint accuracy necessary in neurosurgery for cranial patient data registration
* Includes hardware component in computer-assisted surgery and neuronavigation systems Instrument Calibration Matrix Device for instant intraoperative calibration of length, diameter and vector of a rigid instrument
* Includes real-time views of both unique patient anatomy and surgical instrument positions visualization of patient data and instrument software shapes in 3D for comprising overviews and improved spatial orientation
* Includes microscope navigation software for the integration of compatible surgical microscopes and robotic visualization systems for existing microscope integration
* Includes a head-up display, also known as a HUD or head-up guidance system (HGS), is any transparent display that presents data without requiring users to look away
* Includes augmented reality outlines into ocular for visualization of planned structures injected
* Includes augmented reality video overlay on navigation screen for visualization of injected outlines
* Includes software for 3D Displayed brain structures include anatomical objects, fiber tracts, trajectories, and points
* Includes software tools - Probe's Eye View: Displays the patient's MRI or CT scans as if you are looking directly from the center of the surgical microscope's focal point
* Includes Ergonomic remote control of navigation functionality via microscope handle
* Includes Live Overlays: Projects 3D arrows, floating pins, and paths directly onto the road or sidewalk in front of you through your device's camera
* Includes Visual Positioning System (VPS): Utilizes computer vision and artificial intelligence to scan nearby buildings and landmarks, providing highly accurate localization even in dense urban areas where GPS signals struggle
* Includes Real-Time Data Feeds: Continuously updates with live traffic conditions, construction zones, and road closures without requiring you to switch between applications
* Includes Point of Interest (POI) Tagging: Highlights nearby businesses, restaurants, and transit stops in real-time, displaying ratings and operational details as you scan the street
* Includes Enhanced Safety: Designed to prevent distraction by keeping your eyes on the road (or directly ahead) rather than forcing you to mentally translate a flat 2D map into physical space
* Includes microscope adapter with tracking array for navigation of existing surgical microscope
* Includes Cranial reference arrays track a patient's exact 3D orientation in space for image-guided neurosurgery
* Includes Spare parts for combined use with a second patient reference array cranial with four marker spheres
* Includes four marker geometery spheres software tool to track location of the patient's head
* Includes High-precision manufactured stainless steel
* Includes Autoclavable design for easy sterilization
* Includes ENT Patient Reference Array for dynamic tracking of patient movement
* Includes Single screw fixation on the reference headband
* Includes Integrated calibration points for instant instrument calibration
* Includes Precision manufactured stainless steel for high durability
* Includes Wireless and autoclavable design for fast sterilization
* Includes Reflective Marker Spheres for wireless navigation
* Includes patient reference multi-articulated attachment arm
* Includes compatible Mayfield/metal head holder and T-Adapter to be sterilizable
* Includes ergonomic design and high-quality, corrosion-resistant steel HEX screwdriver T-handle 2.5 MM (x1) for additional tightening and loosening of instrument screws
* Includes adapter to connect instruments such as the Disposable Stylet to the electro magnetic Interface Box
* Includes instrument (Cylindrical) adapter clamps used in conjunction with an optical tracking geometry or an electromagnetic sensor; the instrument adapter clamp easily integrates surgical instruments into surgical navigation through attaching the clamp at a cylindrically shaped part of the instrument
* Includes Support instrument diameters: 2.5mm - 7.0mm
* Includes ergonomic design and high-quality, corrosion-resistant steel single-screw jaw fixation for attaching clamp to the instrument
* Includes Standardize interface for attaching the tracking component to the clamp to be sterilizable
* Includes Atleast 30° angulation of tracking component to instrument axis for computer-assisted robotic surgery
* Includes Instrument Adapter EM and software platform allows the surgical instrument to be tracked in 3D space using electromagnetic (EM) navigation systems—procedures where line-of-sight optical tracking might be obstructed for electromagnetic navigation
* Includes Interchangeable, various sized, sterilizable devices used in image-guided surgery to clamp onto standard surgical tools and feature highly reflective spheres for infrared optical cameras to track the precise position, orientation, and trajectory of the instrument in real-time
* Includes Autoclavable design for fast sterilization
* Includes Ergonomic design and high-quality, corrosion-resistant steel with an instrument adapter clamp used in conjunction with an optical tracking geometry or an electromagnetic sensor, the instrument adapter clamp easily integrates instruments such as forceps into surgical navigation
* Includes Adjustable fixation screw for attaching clamp to the instrument to be sterilizable
* Includes Standardized interface for attaching the tracking component to the clamp to be sterilizable
* Includes Electromagnetic Instrument Adapter navigation. Reusable sterilizable standardized surgical accessory system used in electromagnetic image-guided procedures
* Includes Instrument tracking Instrument Adapter Arrays: These attach to standard surgical tools (pointers, suction devices, forceps, and etc...) and are equipped with reflective marker spheres. Infrared cameras track these spheres in real-time, functioning similarly to a surgical GPS
* Includes Autoclavable design for fast sterilization
* Includes At least a 45-degree offset instrument adapter to provide an additional offset between adapter clamp / array & increases movement space if multiple instruments navigated
* Includes Software Flexible & ergonomic array positioning on instrument free line of sight using alternate technologies
* Includes Offset mounted array allows free sight along instrument axis for 8 different adapter clamp-offset snap-in positions selectable
* Includes Satellites instrument requiring no remote access to VA network or VA patient info alignment pin so VA service can manually secure dish/place dish
* Includes Precision manufactured stainless steel for high durability
* Includes Wireless and autoclavable design for fast sterilization "Full Digital Integration of easily overlay live ultrasound scans onto pre-operative CT/MRIs, allowing for immediate assessment of anatomical changes and deformation (brain shift) during complex cranial procedures
* Includes IT integration including connection to DICOM, setup of DICOM Query Retrieve and DICOM PUSH, modality worklist and intraoperative modality integration, manual/automatic data saving to central archive, active directory integration
* Includes Microscope Interface 4.0 Cable for integration with existing robotic visualization system and advanced visualization system
* Includes image-guided surgery software for Spine and Trauma navigation
* Includes software of manual registration for Spine and Trauma navigation with manual surface-matching
* Includes setup software for spine and trauma navigation
* Includes software image auto registration with 3D C-Arms for Spine and Trauma navigation
* Includes software authorized Registration Hardware Fluoro 3D for GE OEC 3D & ZIEHM RFD 3D
* Includes spine accessory kit parts and software
* Includes software Registration and basic navigation with the pointer
* Includes spine accessory kit Drilling - use of pre-calibrated drill guide tools with adjustable depth control to navigate open thoracic, lumber, cervical, and sacral cases
* Includes spine accessory kit Open surgery - software use of generic pre-calibrated awls and probes to navigate open thoracolumbar and sacral cases
* Includes spine accessory kit Universal Instrument Integration software for registering third party instruments with manual calibration using modular instrument adapter clamps
* Includes spine accessory kit minimally Invasive Surgery – enables reference array attachment with a 2-pin reference clamp and a minimally invasive pedicle access with the dedicated pedicle access needle for the insertion of Kirschner wires with diameters from 1.5 mm to 1.8 mm
* Includes small-footprint ultrasound navigation into cranial procedures digitally fuse and overlay live ultrasound data with pre-operative MRI or CT scans directly in the surgeon's view
* Includes onsite visit for integration and verification of third-party devices including a complete verification of system accuracy and software and hardware functionality
* Includes on-site qualified clinical support by a qualified and trained service staff member for one cranial treatment
* Includes on-site qualified clinical support by a qualified and trained service staff member for one ENT treatment
* Includes onsite qualified cranial application training for all members of clinical staff
* Includes onsite qualified ENT application training for all members of clinical staff
* Includes onsite education and qualified OEM training by a vendor service trained representative will be provided to VAMHCS clinical staff within 10 days of installation
* Includes onsite education and OEM qualified training by a vendor service trained representative shall be provided to the VAMHCS Biomedical Engineer Shop, including the Biomedical Equipment Support Specialists (BESS) within 10 days of installation
* Includes vendor is responsible to coordinate destination delivery, OEM installation, deinstallation, VA TRM compliant software, no remote access, and training with VA COR POC for a fully operational and fully installed equipment and software within one year of award
* Includes qualified vendor must deinstall existing equipment to warehouse for VA property manager disposal
* Includes qualified OEM installer required to certify validation hardware, software licenses, and software associated to the new system, and offered software item approved on OIT VA TRM network
* Includes installation includes authorized DICOM, VA SAAS, and VA TRM compliance
* Includes delivered materials will arrive in manufacturer’s original sealed containers with the associated purchase order number listed on the outside of the box
* Includes upon installation, the contractor shall remove all related shipping debris and packing from the VAMHCS facilities
* Includes delivery and installation shall be completed between 7:00 a.m. and 3:30 p.m. Monday – Friday unless mutually agreed upon. All federal holidays are excluded
* Includes warranty begins upon accepted proof of service for fully operational and installed system
* Includes provide equipment manufacturers’ recommended maintenance schedules, user manual, and operation materials packaged with RFQ response. Manuals should be made available in an electronic format
* Includes authorized OEM vendor is fully responsible for the equipment and software until fully installed and fully operational
* Includes the authorized OEM vendor shall resolve any missing and damaged items found upon install and replaced at no cost to the Government for acceptance of fully installed and operational system
* Includes contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s) for government acceptance
* Includes authorized OEM vendor includes service, repairs, maintenance, software updates maintenance and repair for base year effective upon fully installed and operational
* Includes equipment life expectancy
* Includes at least one year include warranty phone and onsite repairs
* Includes all in-person and remote repairs/support/travel/installer shall be performed by authorized OEM qualified vendor, which has been certified by manufacturer, to perform the repairs/support during the contract period of performance
* Includes manufacturer name/model number
* Includes VA TRM software names/versions
* Includes origin