XTRAC Velocity 7 Excimer Laser

STATEMENT OF WORK STRATA Skin Sciences XTRAC Velocity 7 Excimer Laser Scope Contractor shall furnish including but not limited to all labor, materials, parts, equipment, tools, transportation, and supervision to provide the Michael E DeBakey VA Medical Center (MEDVAMC), 2002 Holcombe Blvd, Houston, Texas 77030 with STRATA Skin Sciences XTRAC Velocity 7 Excimer Laser. The Contractor shall provide all necessary services including setup, configuration, and installation to get the specified equipment working properly. The Contractor shall provide all necessary training to the designated VA employees on how to use the installed equipment after completion of installation. The equipment, all of its accessories, and supplies that come with the equipment shall be brand new. The contractor shall not provide refurbished or used equipment. All work shall be done in a first-class manner. The equipment, all necessary services related to removal, mobile unit usage, setup, configuration, installation, and training services are hereinafter collectively referred as - Deliverables. All Deliverables shall be delivered based on an agreed schedule of work after award, preferably within six months and as free on board (FOB) destination. Background MEDVAMC is requesting purchase of 1 (one each) XTRAC Velocity 7 Excimer Laser for use in the treatment of skin disorders such as psoriasis, vitiligo and atopic dermatological conditions. This treatment provides long lasting remission and relief in 10-12 sessions and eliminates the daily multiple steroidal cream applications giving patients the freedom for better quality of life. This is a replacement of the current Pharos laser device which has reached end-of-life and no longer supported or available. Specific Requirements The contractor shall provide the Michael E. DeBakey VAMC with one STRATA Skin Sciences XTRAC Velocity 7 Excimer Laser that includes the following: New XTRAC Velocity 7 with 1 year warranty 1 each Software upgrades during the 1 year warranty period 1 each Touch control liquid light guide delivery system with 1 each Adjustable iris hand-piece & aiming beam One cylinder of excimer laser gas 1 each One XTRAC laser accessory kit License for royalty-free use for treatment of vitiligo 1 each An excimer laser is an ultraviolet (UV) laser that uses a compound of noble gases, halogen, etc. as its laser medium, typical examples being ArF excimer lasers (wavelength of 193 nm), KrF excimer lasers (wavelength of 248 nm), XeCl excimer lasers (wavelength of 308 nm), and XeF excimer lasers (wavelength of 351 nm). Pulse repetition Rate 400 Hz, spot size: 4.0cm2 (2cm x 2cm), Dose Range 25-5000mi/cm2, laser output power 4.0 -7.2 watts. Physical Attributes: Dimensions: 18 L x 39 D x 34'H Weight: 200 lbs AC Input power: 100-230 VAC 1.2k VA max; 50/60Hz Gas Type: Custom xenon chloride mix Power connector: HBL8215CT (standard hospital grade, 120 V plug) Laser control: User selectable - handpiece Remote Interlock: contact closure, isolated and powered w/24 V DC, 5mA Training The contractor will provide one on-site training session on the proper use of the XTRAC Velocity 7 laser within 30 days of the delivery. Training will be conducted Monday-Friday between 8am and 3pm as date/time agreed upon between parties as to not impact clinical care. Standards Contractor shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by the VAMC, and any upgrades/updates, as well as following most current published standards/ specifications/regulations: Manufacturer s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission (JC), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Underwriters Laboratories (UL) ,Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract. Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, OSHA, VA, and CDRH. The contractor shall supply certification of tuberculosis testing completion prior to commencing any work located on the MEDVAMC campus. The C&A requirements do not apply and a Security Accreditation Package is not required. Testing and Certification Upon completing installation of the system, the Contractor shall notify the Contracting Officer's Representative (COR) in writing that the system is ready for acceptance testing, and that it meets all requirements of the OEM, VA standards and contract requirements. Submission of this notification of system readiness shall be accomplished by the contractor prior to the beginning of the scheduled Government Acceptance Test. Government Acceptance Test The Contractor shall perform the Government Acceptance Test in the presence of the COR for proof-of-performance. The Government Acceptance Test shall be performed within 30 days from the effective date of award. Upon completing the Government Acceptance Test successfully, the Contractor shall document the success of this Government Acceptance Test and furnish a copy to the COR before the Contractor's representative departs the VA premises. Product Modification, Removal or Recall If any product awarded under this solicitation requires modification, is removed or recalled by the Contractor or manufacturer, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps shall immediately be taken by the Contractor: a. Notify the Contracting Officer in writing of the required changes. Provide two copies of the notification which shall include, but not be limited to the following: (1) Complete item description and/or identification, order numbers from customers, and the contract number assigned; (2) Reasons for modifications, removal or recall; and (3) Necessary instructions for return for credit, replacement or corrective action. b. The Contractor shall provide the above information to all agencies and VA facilities who purchased the product. The Contracting Officer shall be provided a copy of the notification as stated above and a list of all agencies and/or VA facilities notified. c. The Contractor shall be responsible for any costs associated with the above. 4. GENERAL INFORMATION 4.1. Delivery Location Michael E. DeBakey Medical Center Building 100 2002 Holcombe Blvd. Houston, Texas 77030 4.2 Place of Performance The Contractor shall deliver and perform all work at the Michael E. DeBakey VA Medical Center, Building #100, located at 2002 Boulevard in Houston, Texas 77030. The contractor shall provide all supplies and necessary services including setup, configuration, and installation for the XTRAC Velocity 7 Excimer Laser in the Dermatology Section as listed in Section 3 above. Hours of Operation Services shall be performed during the VA normal business hours, 8:00 a.m. through 4:30 p.m., Monday through Friday, excluding Federal holidays. Any scheduled work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). VA follows all Federal holidays that are set by law (USC Title 5 Section 6103). The Government hereby provides notice and Contractor 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 20 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 25 In addition to the days designated as holidays, the Government observes the following days: 1. Any other day designated by Executive Order; 2. Any other day designated by the President's Proclamation; and 3. Any other day designated by Federal Statute. 4.3 Period of Performance The Contractor shall deliver all supplies and finish all works of installation, configuration and setup within 30 days from the effective date of award. All training shall be complete by 60 days from the effective date of award. The training shall be provided after the test and acceptance date of the equipment. 4.4 Warranty. Contractor to provide manufacturer's warranty period. All equipment and materials shall come with a standard one-year warranty. Warranty shall begin after completion of test. The Contractor shall be an OEM authorized dealer, authorized distributor or authorized reseller for the proposed equipment and/or services contracts for maintenance of equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the supplies, equipment and/or services contracts for maintenance of equipment shall be in accordance with the OEM terms and conditions. 4.5 Deliverables A. User's Operating and Maintenance Manual. Contractor shall provide a complete set of User's Operating and Maintenance Manual at no charge to the Government. 4.6 Invoicing The Contractor shall not invoice for payment until all of the requirements are complete. VA's Electronic Invoice Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, Vendor Electronic Invoice Submission Methods. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below: - VA's Electronic Invoice Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungstennetwork.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge. - A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org). END OF THE STATEMENT OF WORK