Olympus Soltive Laser System Statement of Need (SON) Background: The Lebanon VA Medical Center (LVAMC) has a brand requirement for one (1) Olympus Soltive Laser System, and accessories. The Olympus Soltive Laser System will be used in the OR for Urological procedures. Scope of Work: The Contractor shall provide all shipping and deliver for One (1) Olympus Soltive Laser System with itemized system requirements noted in the table below for the Lebanon VAMC. No Training or Installation Required. Item Description Catalog Number Quantity TFL PREMIUM LASER SYSTEM TFL-PLS 1 TC-L COMPACT TROLLEY SET 1 TC-L 1 LASER SAFETY GOGGLES EMP-ASG 8 TFL Laser Footswitch Wired TFL-AFSW 1 TFL Laser Blast Shield TFL-ABS 2 TFL Laser Interlock Connector TFL-AIC 1 TFL Laser Warning Sign TFL-AWS 2 Salient Characteristics of the brand name required Olympus Soltive Laser System: Must be all-in-one Platform Must have full and complete range of laser fibers available, starting at 150um up to 940 um for different procedures Must have class 4 Laser Must have wavelength: 1,920 nm- 1,960 nm Must have laser Energy: 0.025 J-6J Must have laser Frequency: 1 Hz-2,400 Hz Must have average Power: 1 W-60 W adjustable Must have pulse duration: 200 us-50ms Must have aiming Beam: Green, 500-550 nm, power adjustable 0-5 mW, Class 3R Must meet electrical requirements: 100-240V at 1,200 VA 50/60 Hz Must be of a compact size dimensions HxWxD: 29.5 x37.0 x 56.0 cm Weight 40kg Must be Air-Laser Cooling System Must Protect against Electric Shock Class 1/type BF Classification of Medical Device Directive Class llb Must have Shockpulse-SE to treat stones from above and below Must offer BPH treatment with prostate enucleation and hemostasis Must plug into any standard 110v wall outlet with no special wiring Must include Auxiliary Screen, wireless footswitch, power cord, and Laser Warning Sign Must include Blast Shield, video cable and video cable adaptor Must include Interlock Connector Must include Thulium Fiber Laser /Laser Fiber Delivery: Delivery shall be within thirty (30) days from the time of award. The Olympus Soltive Laser System, and accessories shall be delivered to the Lebanon VAMC located at 1700 S. Lincoln Ave., Lebanon, PA 17042; Attn; Warehouse. BioMedical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks. GOVERNMENT FURNISHED INFORMATION OR MATERIAL: This acquisition does not include Government-furnished property (GFP), identify in the Statement of Work all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more. This acquisition does not include Contractor-acquired property (CAP). REPORTS/DELIVERABLES: Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Lebanon (595). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. Influenza Vaccination: VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VA. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities follows VHA Directive 1192. HIPAA Training Certificates: If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the POC listed in the awarded contract. Tobacco: All VA Pittsburgh property is tobacco free. Contractor personnel will comply with Altoona VA tobacco and smoking policies. Violations will result in a warning and possible citation. COVID-19 Related Policies: 1. Upon entering VA, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VA. 2. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement. Vendor Credentialing: Vendor access to the VA is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VA is not responsible for this. All vendors are required to check-in at the Symplr kiosk using their smart phone or desktop check-in with Symplr login and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VA sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended.
