Stryker Surgical Video Equipment

Objective The Robert J. Dole VA Medical Center (Dole VA) requires new surgical video equipment to replace the current video system that is end of life. All items shall be new, unused, and all equipment and accessories, software, installation, training, and project management support shall be provided by the vendor. The technical specifications for this requirement are described below. SCOPE OF WORK Vendor shall adhere to all deadlines outlined in Table 1, below. If delays occur, the vendor must notify CO and POC in writing, at least 14 days in advance Any government requested delay for delivery, up to 90 days, shall be at no additional cost to the Government The Vendor shall provide all components required so that the equipment outlined in Section 3 is fully operational. The Vendor shall provide all missing parts, features, software, and/or components, not included, to fully complete the installation at no additional cost to the Government. The Vendor shall provide all labor, supervision, and any other resources required to deliver, assemble/install, and test all listed equipment. The Vendor is responsible for conducting training and in-services and shall provide all labor, supervision, and any other resources required for such training and in-services. All hardware, software, and services must meet the manufacturers and VA specifications. Facility is requesting removal of existing equipment, if there is a turn-in credit offered towards the cost/price of new equipment. Table 1 Description of Vendor Task Deadline Notify POC of equipment delivery At least 10 business days prior to delivery Schedule operator training Prior to equipment delivery Equipment delivery Within 60 days from the effective date of award Install and test all newly purchased equipment Within 90 days from the effective date of award Provide verification documentation Within 3 business days from installation and testing of new equipment Remove all existing equipment and associated accessories Within 90 days from the effective date of award Complete all onsite clinical training Within 90 days from the effective date of award Complete all onsite technical training Within 90 days from the effective date of award Complete all onsite training for cleaning personnel Within 90 days from the effective date of award DELIVERABLES Proposed products must meet all the salient characteristics and functions defined below: Hardware & Software Camera Control Unit Quantity: 6 EA Specification/Salient Characteristics: Minimum resolution: 4K Scalable to accommodate future advancements in peripheral device integration and control The ability to assess perfusion for open surgery Intuitive capacitive touch screen LCD interface for ease of operation Capable of accommodating up to 10 different surgical specialties settings for optimal color resolution and brightness User-friendly and easily understood by nursing staff The ability/compatibility to see lighted ureteral stents that when placed, emits infrared light that can be detected to visualize the ureters (critical anatomy) in real time The ability to see fluorescence in 4K and lighted ureteral stents simultaneously CF Rated Capable of visualizing and highlighting lung and ovarian cancer Can showcase over 1 billion reproducible colors Includes dynamic range enhancements that improve visualization in both the highlights and shadows of the picture to increase clarity and details across the image Has technology been built into the system designed to reduce the effects of RF 5 advanced imaging modes of fluorescence for visualization to accommodate multiple specialties all in 4K Light Source Quantity: 6 EA Specification/Salient Characteristics: It has technology that is designed to increase patient and operating rooms safety by minimizing the amount of time the light source is on, making patient and drape burns less likely Gives real time adjustments of light output to optimize visualization in every surgical scene 2 infrared lasers for advanced imaging (fluorescence/lighted stents) Gives visualize feedback to showcase when light cable is properly seated 32” 4K Wireless Transmitter Quantity: 4 EA Specification/Salient Characteristics: Wirelessly transmits 4K and 1080p signals Improve safety and workflow efficiencies in the OR Eliminate tripping hazards from cabling on the ground Enable a seamless linking process with LED confirmation & permanent and non-permanent pairing options 32” 4K Wireless Receiver Quantity: 3 EA Specification/Salient Characteristics: Wirelessly receives 4K and 1080p signals Improve safety and workflow efficiencies in the OR Eliminate tripping hazards from cabling on the ground Enable a seamless linking process with LED confirmation & permanent and non-permanent pairing options 32” 4K OLED Surgical Display & Covers Quantity: 11 EA Specification/Salient Characteristics: Resolution: 4096 x 2160 Size: 32” corner to corner Ability to represent 1.07 billion different colors Offers crisp contrast ratio of 1,000,000:1 OLED technology with self-illuminating pixels, eliminating the need for external backlighting 0.1 ms response time for no detectable image lag 14.0 lbs. for easy installation in both integrated and cart-based rooms 9 preset surgical specialties Includes 32" 4K OLED display covers OLED Surgical Display Cover Quantity: 11 EA Specifications/Salient Characteristics: Intended to protect your displays from scratches/damage prolonging your investment Easily removable for cleaning Quick and seamless “install” Highly durable Camera Head Quantity: 12 EA Specification/Salient Characteristics: CMOS 3-Chip camera technology designed for enhanced light sensitivity and increased patient safety Programmable to control OR equipment from camera head Ergonomic lightweight design for minimally invasive surgery Insufflator Quantity: 6 EA Specifications/Salient Characteristics: Enhances image clarity For laparoscopic and robotic surgery Removes surgical smoke for a safer work environment 6 unique operating modes All-inclusive system with integrated heating, humidification, and smoke evacuation capabilities 4 interchangeable tube set options Light Cable Quantity: 12 EA Specifications/Salient Characteristics: Scope sensing technology that automatically turns the light off when the scope is disconnected from the light cable Fiber optic cable Compatible Advanced Imaging modes Fluorescence Consistent lighting in small cavities Auto light feature Overlay mode to highlight ICG Contrast mode Portable Handheld Fluorescence Imager Quantity: 1 EA Specifications/Salient Characteristics: Intuitive operator controls Comfortable single-handed operation Indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, and plastic, microsurgical, and reconstructive surgical procedures System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes 1080p x 60fps Indicated for use in adult and pediatric patients one month of age and older Combine enhanced fluorescence signal information with vivid white light images in real-time 4 fluorescence modes for visualization Software allows the surgeon to further evaluate the intensity of the fluorescence signal in real time through relative percentage values and a color maps mode The ability to visualize lymphatic channels through the skin. Portable Handled Fluorescence Imager Video Processor Quantity: 1 EA Specifications/Salient Characteristics: Features a timer that is automatically activated when fluorescence is detected, and icons indicating ingress and the fluorescence assessment window Involves no ionizing radiation and utilizes a non-nephrotoxic fluorescence imaging agent with a very short half-life thus allowing surgeons to repeat intraoperative perfusion assessment numerous times throughout the procedure The ability to visualize lymphatic channels through the skin. Secondary Monitor Roll Stand Quantity: 3 EA Specifications/Salient Characteristics: Intended to support a secondary monitor that is used in operating rooms. Intended to be used as a peripheral observation station that is used for viewing images Power supply bracket 5 cable clip brackets for cable management Pneumatic pressure height adjustment 2 locking casters Swivel adjustment lever Mobile Surgical Equipment Cart Quantity: 4 EA Specifications/Salient Characteristics: Monitors stow feature & adjustable arm increases maneuverability and transport with ease Data port panel on back of cart provides access to connect peripheral devices Integrated cable management system for less clutter of cables No doors, giving increased access points and reduced footprint Interchangeable shelves Laparoscope Autoclavable 5.4mm 0 Deg 30cm Quantity: 6 EA Specifications/Salient Characteristics: Built in technology to visualize fluorescence and advanced imaging in 4K Bulit in adapter to optimize technology that turns off light cable when not in use saving patient/drape burns Each rod lens is coated with proprietary technology, allowing users to toggle between white light and fluorescence modes without delay or compromise in image quality Laparoscope Autoclavable 5.4mm 30 Deg 30cm Quantity: 6 EA Specifications/Salient Characteristics: Bulit in adapter to optimize technology that turns off light cable when not in use saving patient/drape burns Built in technology to visualize fluorescence and advanced imaging in 4K Each rod lens is coated with proprietary technology, allowing users to toggle between white light and fluorescence modes without delay or compromise in image quality Laparoscope Autoclavable 10mm 30 Deg 33cm Quantity: 3 EA Specifications/Salient Characteristics: Bulit in adapter to optimize technology that turns off light cable when not in use saving patient/drape burns Built in technology to visualize fluorescence and advanced imaging in 4K Each rod lens is coated with proprietary technology, allowing users to toggle between white light and fluorescence modes without delay or compromise in image quality Laparoscope Autoclavable 10mm 0 Deg 33cm Quantity: 3 EA Specifications/Salient Characteristics: Bulit in adapter to optimize technology that turns off light cable when not in use saving patient/drape burns Built in technology to visualize fluorescence and advanced imaging in 4K Each rod lens is coated with proprietary technology, allowing users to toggle between white light and fluorescence modes without delay or compromise in image quality Cystoscope/Hysteroscope Autoclavable 4mm 30 Deg Quantity: 4 EA Specifications/Salient Characteristics: Indicated for use in Urology/GYN cases Advanced imaging capabilities to localize bladder tumors Cystoscope/Hysteroscope Autoclavable 4mm 0 Deg Quantity: 4 EA Specifications/Salient Characteristics: Indicated for use in Urology/GYN cases Advanced imaging capabilities to localize bladder tumors Arthroscope Autoclavable 4K 4mm 30 Deg Quantity: 5 EA Specifications/Salient Characteristics: Indicated for use Arthroscopy cases 165mm working length 105 Deg field of view Arthroscope Autoclavable 4K 4mm 70 Deg Quantity: 5 EA Specifications/Salient Characteristics: Indicated for use Arthroscopy cases 165mm working length 105 Deg field of view Arthroscope Shaver and Bur Handpiece Quantity: 5 EA Specifications/Salient Characteristics: Indicated for use Arthroscopy cases Ability to run up to 12,000 RPM’s Chip technology – Each disposable is individually programmed with optimized settings Straight, Hip, Small-Joint, and Angled Offerings ‘Subchondral drill’ option designed for efficient microfracture by plugging directly into handpieces Arthroscope Resection Console Quantity: 3 EA Specifications/Salient Characteristics: Indicated for use Arthroscopy cases Two-in-one console and footswitch Technology allows to integrate with an arthroscopy pump, optimizing suction and flow rates per disposable Integrated foot pedal controls energy probe, shaver handpiece, and arthroscopy pump functionality Ability to change COAG intraoperatively from 19 to 56 watts Fully customizable for surgeon specific RPM, COAG and CUT settings. Arthroscope Resection Console Footswitch Quantity: 3 EA Specifications/Salient Characteristics: Indicated for use Arthroscopy cases Ability to control both radio frequency and shaver functionality Eliminates the need for a second foot pedal Programmable button mapping to accommodate surgeon preferences Arthroscope Fluid Management Console Quantity: 3EA Specifications/Salient Characteristics: Indicated for use Arthroscopy cases Integrates with shavers and radio frequency devices by optimizing suction rate for each disposable Surgeon-profiles can be pre-programmed to control features like joint pressure and flow, shaver and radio frequency settings, on screen displays, and footswitch and hand control settings Built in intelligence system providing users “how to” instructions for each console features and function Pencil Obturator 5.8 MM Pump Cannula Quantity: 6 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Used to avoid fluid leakage and allow smooth sliding of instruments. Smooth low friction surfaced. 4.0 Operative Inner Sheath Quantity: 4 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Reusable 4.0 Operative Outer Sheath Quantity: 4 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Reusable 4.0 Diagnostic Inner Sheath Quantity: 4 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Reusable 4.0 Diagnostic Outer Sheath Quantity: 4 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Reusable Instrument Endoscope Tray Quantity: 6 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Safe storage for endoscope camera Reusable Laparoscope Tray Quantity: 12 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Safe storage for laparoscope camera Reusable Urology Gynecology Accessories Tray Quantity: 4 EA Specifications/Salient Characteristics: Surgical grade Stainless Steel Safe storage for urology/gynecology accessories Reusable 5.8 cannulated w/ 2 rotating stopcocks Quantity: 6 Specification/Salient Characteristics: Allows for outflow/inflow to be controlled by the Surgeon. Adapter Speed-Lock Cystoscopes Quantity: 6 Specification/Salient Characteristics: Adapter that allows for scopes to be quickly attached to camera head Cutter/Cannula 4.5mm Quantity: 5 Specification/Salient Characteristics: A cutter cannula features a unique cutting edge to facilitate tissue resection and is compatible with instruments such as shavers Obturator 4.5mm Quantity: 5 Specification/Salient Characteristics: Helps create and maintain an access path for inserting instruments and an arthroscope into a joint Cutter Bur Cannula 5.6mm Quantity: 5 Specification/Salient Characteristics: Allows for the precise resection (cutting and removal) of tissue and bone within a joint or surgical site, often while providing visualization and fluid management for the procedure. Obturator 5.6mm Quantity: 5 Specification/Salient Characteristics: Helps create and maintain an access path for inserting instruments and an arthroscope into a joint Irrigation Adapter Quantity: 5 Specification/Salient Characteristics: flushes the surgical site with sterile fluid to keep it clean, remove debris and bacteria, and maintain clear visibility for the surgeon Other Deliverables Service manual Quantity: 2 EA Specification/Salient Characteristics: Language: English Provided by manufacturer Includes manufacturer’s instructions for service, maintenance, and repair of CLIN 001, 002, 003, 004, 005, and 008 Operator’s manual Quantity: 2 EA Specification/Salient Characteristics: Language: English Provided by manufacturer Includes manufacturer’s instructions for end user operation of CLIN 001, 002, 003, 004, 005, and 008 Clinical Training Quantity: 1 JB Specification/Salient Characteristics: On-site training program for in-house clinical personnel. Training for clinical personnel must provide nurses, providers, and all other clinical staff with the tools and knowledge to fully operate the devices/software and conduct checks per the manufacturer’s instructions and hospital regulations, as well as answer any questions personnel may have regarding the new equipment/software. Training must also equip education personnel to provide refresher training for current clinical staff and to train new clinical staff for future training sessions, following this training. Vendor shall provide on-site training of the equipment to the clinical users according to training deadlines outlined in Table 1. Vendor shall coordinate all training dates with POC (or designee) who will communicate internally with appropriate VA staff. If applicable, Vendor shall include all travel, registration, and other associated costs to provide this training in their proposal. Personnel Training Quantity: 1 JB Specification/Salient Characteristics: On-site training program for in-house cleaning/housekeeping personnel. Training to provide staff with the tools and knowledge to properly clean the devices without damaging the equipment, according to the manufacturer’s instructions and hospital regulations. Training to also answer any questions staff may have regarding the new equipment. Training must also equip education/supervisory personnel to provide refresher training to current Sterile Processing staff and to train new employees in the future. Vendor shall provide on-site training of the equipment according to training deadlines outlined in Table 1. Vendor shall coordinate all training dates with POC (or designee) who will communicate internally with appropriate VA staff. Technical On-Site Training Quantity: 1 JB Specification/Salient Characteristics: On-site training program for the biomed technicians. Technical training must provide up to 10 biomed personnel with the tools and knowledge to fully operate, maintain troubleshooting, and repair the system by OEM standards, as well as answer any questions personnel may have regarding the new equipment. Vendor shall provide on-site training of the equipment to the technical staff according to training deadlines outlined in Table 1. Vendor shall coordinate all training dates with POC (or designee) who will communicate internally with appropriate VA staff. Technical Off-Site Training Class, if offered Quantity: 1 JB Specification/Salient Characteristics: Off-site training class for at least 1 biomed technician. Technical training must provide at least 1 biomed technician with the skills and knowledge to fully operate, maintain, troubleshoot, and repair the system by OEM standards. Any certifications required or offered to service equipment will be provided. Vendor shall provide off-site training within 6 months of the conclusion of manufacturer’s warranties of the equipment to ensure seamless transition of equipment maintenance. Vendor shall coordinate training with POC (or designee) and designated biomed employee to be trained. If applicable, Vendor shall include all travel, registration, and other associated costs to provide this training in their proposal. Shipping and Delivery Quantity: 1 JB Vendor shall deliver all equipment to: Robert J. Dole VA Medical Center ATTN: Healthcare Technology Management 5500 E. Kellogg Wichita, KS 67218 Ensure that equipment is sent to the Attention of Healthcare Technology Management (formerly Biomedical Engineering). Include the PO Number on the shipping label. Deliver materials to the facility in manufacturer's original sealed boxes or containers with brand name marked thereon. Package to prevent damage or deterioration during shipment, handling, and storage. Maintain protective covering in place and in good repair until delivery is necessary. Vendor shall notify POC of delivery dates according to timelines outlined in Table 1. POC must confirm delivery and installation dates before equipment is received on station. This is to allow VA personnel to be prepared to receive, install, and deploy the equipment upon its arrival. Delivery must be in accordance with Hours of Operation and federal holidays in Section 7. Delivery of oversized, palletized orders, or orders that contain many components will be coordinated with the POC who will communicate internally with Warehouse Staff. Vendor shall adhere to all equipment delivery deadlines outlined in Table 1. Assembly, Installation, and Testing Quantity: 1 JB Vendor shall be responsible for: The vendor shall conduct a meeting at least 3 business days prior to delivery date to plan and coordinate equipment arrival, assembly, testing, and deployment. Vendor responsible for assembly and installation of systems. Install shall include unboxing, assembly, implementation, and testing of all purchased hardware, features, software, and interfaces to VA electronic systems in coordination with clinical staff, Healthcare Technology Management (formerly Biomedical Engineering) staff, OI&T staff, and others identified as needed. Vendor shall provide all necessary accessories, cables, adapters, etc. to deliver a fully functional clinical device/system. Vendor must test and verify all equipment, components, and accessories are fully operational and ready for use in accordance with manufacturer’s recommendations. Vendors must provide documentation of their verification. At a minimum, documentation must include equipment serial numbers, description of work completed, date completed, company name, and name and signature of the person who completed the work. Vendors shall adhere to all assembly, installation, and testing deadlines in Table 1. Vendor shall adhere to all equipment removal deadlines outlined in Table 1. Facility is requesting the removal of existing equipment if a trade-in value can be incorporated in total cost of new equipment. Warranty & Service Quantity: 60 months The Vendor shall provide: Minimum of 1 year warranty Include 60 months of service equivalent to the Procare plan All manufacturers’ warranty with products upon acceptance by the VA Medical Center. Warranty – The system, all accessories, and all software shall be covered under the manufacturer’s warranty and shall include all parts and labor. The warranty period shall not begin until after the Dole VA POC or designee has accepted the products’ delivery, installation, and functionality. A manufacturer’s factory-trained Field Service Engineer shall perform installation and corrective and preventative maintenance during the warranty period. The warranty shall include all manufacturers recommended Preventive Maintenance procedures for its duration. All available software updates and security patches will be made available to the Dole VA during the warranty period. The vendor shall provide documentation of all work completed (corrective maintenance, preventive maintenance, software updates, etc.) within 3 business days of completion. At a minimum, documentation must include equipment serial numbers, work completed, date completed, company name, and name and signature of the who completed the work. The vendor shall provide a response to applications and technical calls within 8 hours. Vendor shall ship replacement parts within 48 hours of identifying necessity by Dole VA Healthcare Technology Management (formerly Biomedical Engineering) staff. Trade-in Credit (optional) Quantity: Specification/Salient Characteristics: Include trade-in value deduction on bid price in exchange for equipment available for trade in. Removal of existing equipment if there is a turn-in credit offered. The contractor shall adhere to all equipment removal deadlines Points of contact The vendor must include all of the following contacts in all email communications, unless instructed otherwise- COR: PSA Surgery Project Manager: Biomedical Engineer, Healthcare Technology Management Key Stakeholders: OR Nurse Manager Network Security & Connectivity Requirements OEM-supported operating system Latest DICOM print, store, commit, structured report (SR), and modality worklist Wireless connectivity to VA network—Compatible with 802.11b/g/n and FIPS 140-2 or FIPS 140-3 compliant TRM approved software Remote vendor access (i.e. an approved MOU ISA) ERA Encrypted hard drive Compatible/interfaces with Federal Electronic Health Record Compatible/interfaces with the following- VAPACS-VISTA IMAGING/VISTA WORKLIST Software-VISTA IMAGING/VISTA WORKLIST Other equipment/system-STRYKER OR HUB INTEGRATION Advanced Visualization system-STRYKER VISUALIZATION SYSTEM The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days. All other vulnerabilities shall be remediate as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. SITE Conditions and Protection of Property Vendor representatives must check in with Dole VA Biomedical Engineering when they arrive on-site and check out upon completion of work each day. Vendor on-site visits shall be coordinated with the POC (or designee) before being scheduled or conducted. There shall be no smoking or vaping on Dole VA premises at any time. Eating and drinking are not allowed inside the hospital, except for in the Canteen Dining area. Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center. Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes, but is not limited to, removal of packaging and a clean sweep/mop of the area as required by work type. Vendors shall protect all items from damage. The Vendor shall take precautions against damage to the building(s), grounds, and furnishings. The Vendor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Vendor. The Vendor shall perform an inspection of the building(s) and grounds with the POC prior to commencing work to ensure that the Vendor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Vendor. The source of all repairs beyond simple surface cleaning is the facility construction Vendor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and POC is required before the Vendor perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work. Vendor staff shall minimize noise as much as possible while working in all buildings. Vendor is responsible for providing all PPE necessary for their work. The Vendor shall be responsible for security of the areas in which the work is being performed prior to completion. Hours of operation Normal hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. Central Standard Time, excluding Federal holidays. The Government hereby provides notice, and Vendor hereby acknowledges receipt that Government personnel observe the listed days as holidays: New Year's Day January 1 Martin Luther King's Birthday Third Monday in January President's Birthday Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas December 25th In addition to the days designated as holidays, the Government observes the following days: Any other day designated by Executive Order. Any other day designated by the President’s Proclamation; and Any other day designated by Federal Statute. All services shall be performed during normal hours unless prior approval is granted and scheduled with the COR. Work performed outside normal hours will be at no additional cost to the Government.

• NAICS339112
• PSC6515

• J_A_Redacted.pdf

  .pdf411 KBNot yet available
• 36C25526Q0665.pdf

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• Tracie Raggs
  Contracting Officer
  tracie.raggs@va.gov913-946-1985