FBODaily.com | FedBizOpps: FILE | 65 | ENT NAVIGATION SYSTEM - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 01, 2013 FBO #4207
DOCUMENT

65 -- ENT NAVIGATION SYSTEM - Attachment

Notice Date: 5/30/2013
Notice Type: Attachment
NAICS: 339112 — Surgical and Medical Instrument Manufacturing
Contracting Office: Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
ZIP Code: 23667
Solicitation Number: VA24613Q1457
Response Due: 6/11/2013
Archive Date: 7/11/2013
Point of Contact: John J Summers
E-Mail Address: 6-6048<br
Small Business Set-Aside: N/A
Description: The Department of Veterans Affairs, VISN 6 Network Contracting Office (NCO), on behalf of Veterans Affairs Medical Center Salisbury, NC is conducting market research through this sources sought notice to help determine the availability of qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses or Small Businesses to provide one ENT Navigation System that includes the following: 1 B12601 COMPREHENSIVE ENT NAVIGATION SYSTEM PACKAGE Comprehensive Package for image guided surgery for ENT indications including refurbished navigation system, standard instrumentation, ENT Navigation Software, Installation & Training: E19507 - REFURBISHED KOLIBRI NAVIGATION STATION 2.0 (WITH MOBILE CAMERA STAND 2.0) Refurbished, mobile, space saving high performance Image-Guided-Surgery station, integrated in an ultra mobile cart with a separated mobile camera stand for flexible positioning of the refurbished infrared cameras, featuring Brainlab's advanced optical, wireless passive marker tracking technology: oIntegrated lightweight design for easy system relocation oTotal surgical control in sterile field on a fingertip, accessible via swivel-mounted / adjustable 17" touchscreen oRapid data transfer directly to the navigation station, eliminating the need of an additional "Planning & Transfer station" oEasy accessible, top-mounted and integrated CD-RW/DVD-ROM combo-drive and USB 2.0 port for direct data import oBuilt in computer with Pentium IV / 3.0GHz Central Processor Unit oMobile cart w. uninterrupted power supply, shelf, keyboard, mouse oMobile Camera Stand 2.0 for mounting and adjusting the Camera Kit. oMobile Stand is equipped with Cart docking mechanism for easy transportation and storage 30038 - UNIVERSAL DICOM TRANSFER Universal patient data communication software that allows for import of patient data in DICOM format on Brainlab systems. oImport from any data sources including PACS ("Query/Retrieve" and "Push"), USB, CD/DVD and network oImport of any modalities including CT, MR, PET/SPECT, X-ray oSelection of patient from patient list on PACS (C-FIND) oPACS access via DICOM "Query/Retrieve" (compatible to all major PACS systems) oReceipt of data via DICOM "Push" oScreenshots taken on the system can be send to PACS in DICOM format (C-STORE) oGeneric license valid for all applications (navigation and planning) installed on system 22215 - NAVIGATION SOFTWARE ENT Image-guided surgery software for head and neck indications: oUser interface specially designed for intra-operative touch screen control oCamera alignment assistance for easy navigation setup oReal-time tracking and 2D/3D visualization of a pointer and up to 4 instruments simultaneously in various views oNavigation on multiple (fused) data sets of different modalities such as CT, MR, NM incl. CT/MR-Angio and Perfusion data o'Patient Browser' interface to select and load patient data before surgery and to add data sets at any time during surgery oInherent safety check advice oMultiple predefined screen layouts, customizable per user oAutomatic maximization of 3D/Endoscope view if no instrument is navigated oQuick multiple-choice configuration of single views oMenu bar switch to toggle between standard and enlarged navigation views oInteractive display of patient data including scroll, pan, zoom and windowing adjustment oScreenshot feature for documentation purposes oDynamic patient referencing for positional independence REGISTRATION oStandard patient registration without foot pedals by simply pivoting the pointer in the patient markers in any order oSemiautomatic Multi-Modality Fiducial/Donut Marker detection oDigitizing of anatomical landmarks for re-registration oColor-coded registration accuracy mapping with distance to surface indication (requires surface matching registration) oAnimated registration 'Guide' for set-up specific support with continual feedback (requires surface matching registration) PLANNING oFully compatible with iPlan ENT and iPlan CMF for pre-operative definition of objects, mirroring planes, import and export of STL-data and planning of trajectories oVirtual tool tip extension for approach simulation oPlanning, adjustment and review of multiple trajectories including navigated entry point definition oDynamic visualization of distance to target point and intra-operative landmarks for approach optimization o'Auto Pilot' view for guided instrument alignment to a trajectory o'Patient Browser' interface to save all changes and additions performed during navigation as additional plan INSTRUMENTS oIntuitive calibration of additional instruments on the fly with instrument adapters (S,M,L,XL clamps with M,ML,L,XL arrays) oDetailed instrument calibration with diameter, length and vector using the 'Instrument Calibration Matrix' (Revision 4) oPathway control of instruments through data sets displayed in pre- or user-defined 'Inline' and 'Probe's Eye' views oVisualization of patient data and actual instrument shapes in 3D for comprising overviews and improved spatial orientation oPoint-to-point distance indication of tracked instruments oAuto-zoom in to tool tip for magnification of target area oIntegration of video signals for live display on the navigation screen (S-Video format minimum requirement: Kolibri 2.0.2) oOptional support of 'Pre-operative Automatic Image Fusion' oOptional support of surface matching registration oOptional support of various third party surgical microscopes oOptional support of various third party ultrasound devices oOptional support of 'Research Link To Navigation' (Open IGT) oOptional support of 'Painter' software oOptional support of 'Automatic Image Registration' for iCT and iMRI (2.0) Brainsuite environments oOptional support of 'Data Set Alignment' software oOptional support of 'Object Shift' software oMinimum requirement: VectorVision WS 6 (min. 2GB RAM) or Kolibri 2 (min. 2GB RAM) 21804 - SURFACE MATCHING REGISTRATION SOFTWARE Software for patient registration in the OR without markers oRegistration based on existing CT or MRI data sets oMinimizes skin-shift inaccuracies compared to marker-based registration methods o3D display of patient data for registration area identification o3D threshold adjustment for optimized registration results oAnimated registration 'Guide' for set-up and tool specific support with continual feedback (Cranial/ENT 2.1 or higher) oSelective acquisition of registration points by simply touching the patients' skin with the Softouch registration pointer oSelective contactless acquisition of 3D coordinates directly projected onto the patients' skin with z-touch laser pointer oVisual and acoustic registration status information oAutomatic correlation of acquired points with anatomical data oRegistration result rating (good, medium) for increased safety oEasy verification of registration result through display of acquired points in the 3D patient data view oColor-coded registration accuracy mapping with pointer distance to surface indication (with VV 7.9 or higher) oPossibility to acquire additional points to "improve" registration result (with VV 7.9 or higher) oNo manual re-editing of acquired data points necessary oNo additional registration of reference structures necessary oRequires 18390 SOFTOUCH REGISTRATION POINTER and/or 41990 Z-TOUCH LASER POINTER oMinimum requirement software: VectorVision Cranial/ENT 7.0 or Kolibri Cranial/ENT 2.0 41798 - INSTRUMENT ADAPTER ARRAY SIZE M Tracking array, connected to ''Instrument Adapter Clamp'', enables navigation of virtually any pre-existing surg. instrument: oArray-Clamp interface (STARLINK) allows exchange & integration of different sized instrument adapter clamps, enabling the user to select the best fit for existing surgical instruments oPrecision manufactured stainless steel for high durability oWireless and autoclavable design for fast sterilization oRequires the "Reflective Marker Spheres" and "Instrument Adapter Clamp" for the wireless navigation 41801 - INSTRUMENT ADAPTER ARRAY SIZE L Tracking array, connected to ''Instrument Adapter Clamp'', enables navigation of virtually any pre-existing surg. instrument: oArray-Clamp interface (STARLINK) allows exchange & integration of different sized instrument adapter clamps, enabling the user to select the best fit for existing surgical instruments oPrecision manufactured stainless steel for high durability oWireless and autoclavable design for fast sterilization oRequires the "Reflective Marker Spheres" and "Instrument Adapter Clamp" for the wireless navigation 55002 - INSTRUMENT ADAPTER CLAMP SIZE M Used in conjunction with an ''Instrument Adapter Array'', the instrument adaptor clamp easily integrates a wide range M (medium) sized surgical instruments into surgical navigation: oAdjustable width jaws are sized via adjustment screw oClamp-Array interface (STARLINK) for fast attachment and exchange of different sized "Instrument Adapter Arrays" oInterchangeable Clamp-Array combination enables to select the best fit for existing surgical instruments oPrecision manufactured stainless steel for high durability oWireless and autoclavable design for fast sterilization 55003 - INSTRUMENT ADAPTER CLAMP SIZE L Used in conjunction with an ''Instrument Adapter Array'', the instrument adaptor clamp easily integrates a wide range L (large) sized surgical instruments into surgical navigation: oAdjustable width jaws are sized via adjustment screw oClamp-Array interface (STARLINK) for fast attachment and exchange of different sized "Instrument Adapter Arrays" oInterchangeable Clamp-Array combination enables to select the best fit for existing surgical instruments oPrecision manufactured stainless steel for high durability. Wireless and autoclavable design for fast sterilization 55061 - TOOL FOR INSTRUMENT ADAPTER Allen key for fixation of Instrument Adapter Array 41985 - Z-TOUCH LASER POINTER Battery powered wireless laser pointer for quick and accurate markerless patient registration: oNo patient markers or fiducials and extra scans required oTouchless registration eliminates patient skin-distortion oPilot laser beam for selective and easy acquisition of optimal anatomical features at the patient's surface oOnly system to acquire projected 3D laser points directly in the patient coordinate system, maximizing accuracy oZ-touch comes in a 3-in-one storage case for the Z-touch pointer, Softouch pointer, BrainLAB Pointer (sharp or blunt tip), and all related accessories oRequires "Surface Matching Registration Software" (art.no. 21804 oCompliant with IEC 60601-1:2005 (3rd Ed.) oLaser product Class 3R according to IEC 60825-1:2007 (2nd Ed.) 52311 - STERILIZATION TRAY ENT/CMF For safe, efficient sterilization (autoclaving) and storage of Brainlab instruments 53106 - POINTER WITH BLUNT TIP FOR CRANIAL/ENT (x 2) Standard instrument for the intra-operative registration of anatomical landmarks and surface point acquisition: oRounded tip for sliding and continuous point acquisition oWireless and autoclavable design for fast sterilization oRequires Reflective Marker Spheres for wireless navigation oContains a blunt tip pointer and the corresponding gauge to be stored in sterilization tray 41874 - INSTRUMENT CALIBRATION MATRIX (Rev.4) Device for instant intra-operative calibration of the length, diameter and vector of any rigid surgical instrument: oPrecision manufactured stainless steel for high durability oWireless and autoclavable design for fast sterilization oRequires Reflective Marker Spheres for wireless navigation 2 B12203. Minimum SW version: VV cranial 6.01, -ENT 6.01, -Hip 2.0, -Knee 1.5, -Spine 5.1, Kolibri cranial / ENT 1.0 41877 - REFERENCE HEADBAND STAR (x 2) Enables dynam Minimum SW version: VV cranial 6.01, -ENT 6.01, -Hip 2.0, -Knee 1.5, -Spine 5.1, Kolibri cranial / ENT 1.0 41877 - REFERENCE HEADBAND STAR (x 2) Enables dynamic tracking of patient movement: oSingle screw fixation on the Reference Headband oIntegrated calibration point for instant instrument calibration oPrecision manufactured stainless steel for high durability oWireless and autoclavable design for fast sterilization oRequires Reflective Marker Spheres for wireless navigation 55013 - INSTRUMENT ADAPTER OFFSET-LINK 45 � / 20mm (STARLINK) Provides an additional offset between adapter clamp / array & increases movement space if multiple instruments navigated: oFlexible & optimized array positioning on instrument according to surgeons preference & free camera-array line of sight oOffset mounted array allows free sight along instrument axis o8 different adapter clamp-offset snap-in positions selectable o8 different adapter array-offset snap-in positions selectable oCompatible with STARLINK instruments without alignment pin oPrecision manufactured stainless steel for high durability oWireless and autoclavable design for fast sterilization 81001-01 - NAVIGATION SYSTEM INSTALLATION (1 MOBILE UNIT) BL SW installation off-site / on-site, HW set up on-site & test: oAssembly of all hardware & computer components oTesting & verifying of data transfer by scanning a test phantom and simulation of the data transfer specific steps oAcceptance protocol according to quality system oVerification of completeness, functioning, precision, faultlessness of all soft-and hardware components 81023-01 - CLINICAL CONSULTATION ENT - 1 CASE (x 3) On-site clinical support for a case with BrainLAB equipment. Applicable to an ENT case. Facilitated by qualified and trained BrainLAB Support Personnel. Requires 48 hours advance notice. 81022-05 - BRAINLAB ACADEMY OAT: ENT (1 DAY) The BrainLAB Onsite Application Training Program (OAT) is a three-hour training program for all members of a clinical team who utilize BrainLAB VectorVision � IGS products. Onsite training offers participants the opportunity to gain a basic proficiency and comfort level in using IGS technology. Participants use the equipment and software to demonstrate proficiency in OR setup, patient registration, planning, navigation, and basic troubleshooting for a navigated case. Each one-day OAT purchase includes the following: o(2) three-hour training sessions for staff and surgeons, maximum six participants per session oCEU/CE accreditation oParticipant educational materials oTravel and accommodations for Application Trainer ENT OAT purchases are transferable toward CMF product training. ENT ACCESSORIES SUCTION TUBE PACKAGE CHARR 8 55790-10 - SUCTION FRONTAL SINUS (CHARR. 8) LEFT STARLINK INTERFACE Suction device equipped with ''Starlink Inteface'' for wireless navigation in combination with a "Instrument Adapter Array" Tissue safe tip design Double bent design for approach to frontal sinus Designed for left-handed users Wireless and autoclavable design for fast sterilization Requires ''Instrument Adapter Array (Starlink)'' 55790-20 - SUCTION FRONTAL SINUS (CHARR. 8) RIGHT STARLINK INTERFACE Suction device equipped with ''Starlink Inteface'' for wireless navigation in combination with a "Instrument Adapter Array" Tissue safe tip design Double bent design for approach to frontal sinus Wireless and autoclavable design for fast sterilization Requires ''Instrument Adapter Array (Starlink)'' 55790-50 - SUCTION MAXILLARY SINUS (CHARR. 8) STARLINK INTERFACE Suction device equipped with ''Starlink Inteface'' for wireless navigation in combination with a "Instrument Adapter Array" Tissue safe tip design Designed for approach to maxillary sinus Wireless and autoclavable design for fast sterilization Requires ''Instrument Adapter Array (Starlink)'' 55790-05 - SUCTION STANDARD (CHARR. 8) STARLINK INTERFACE Suction device equipped with ''Starlink Inteface'' for wireless navigation in combination with a "Instrument Adapter Array" Tissue safe tip design Geometry: 0 � offset, 35 mm with tip end of 45 � offset, 95 mm Wireless and autoclavable design for fast sterilization Requires ''Instrument Adapter Array (Starlink)'' The capability statements received from this market research are for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not assume any costs incurred by the contractor in the preparation of response. All responses shall be submitted in writing no later than June 6, 2013, 12:00 PM, EST to the attention of: John J. Summers, VA Medical Center, 27 Averill Avenue, Hampton, VA 23667. E-mail address: john.summers2@va.gov
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/HaVAMC/VAMCCO80220/VA24613Q1457/listing.html)
Document(s): Attachment; File Name: VA246-13-Q-1457 VA246-13-Q-1457_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=781063&FileName=VA246-13-Q-1457-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=781063&FileName=VA246-13-Q-1457-000.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: Salisbury VAMC;1601 Brenner Avenue;Salisbury, NC; Zip Code: 28144
Record: SN03075490-W 20130601/130530235108-4b40cf05f7480f9d11163446be0bbdc3 (fbodaily.com)
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65 -- ENT NAVIGATION SYSTEM - Attachment