6515--Lubbock Anesthesia Cart

STATEMENT OF WORK (SOW) PURPOSE: The purpose is to procure a brand name or equal Perseus Anesthesia Machines and accessories for the Amarillo VA Medical Center. GOVERNMENT FURNISHED RESOURCES: Information Sources. Agency personnel shall be available for technical exchanges. Documentation: Packing list shall include lot numbers, serial numbers and expiration dates of all delivered products and equipment. SECURITY REQUIREMENTS: In reference to VHA Handbook 6500.6 Appendix A, Blocks 6 and 7, the equipment included in this contract does not capture and process ePHI over the hospital network. In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment (or service) included in this contract does not involve connection of IT devices to a VA network. Therefore, C&A, SAP, & the following from App C do not apply. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information

protection, patient privacy, and information system security as delineated in this contract. During install, training, warranty repair and/or maintenance provided by the contractor, they may have physical administrative access to the equipment included in this contract that capture and process ePHI. If warranty repair is done off-site, all hard drives or other data storage devices will be removed or purged of data, prior to release to contractor. Privacy and HIPAA Focused Training Web-Based (WBT): VA Course No. VA10203 is the official privacy training for VA employees, contractors, and volunteers who have access to protected health information (PHI) in the performance of their official duties or have access to VA systems (e.g. CPRS or VistA Web). All contracted employees will complete this training prior to being granted access to the subject equipment, or to the data therein. The training is available on the VA TMS website at: https:// www.tms.va.gov. Contractor will provide evidence of training to the COR, if requested. The Contractor personnel must follow all VA policies, standard operating procedures, applicable laws and regulations while on VA property. Violations of VA regulations and policies may result in citation and disciplinary measures for persons violating the law. The Contractor must obtain all necessary licenses and/or permits required to perform the work, except for software licenses that need to be procured from a Contractor or vendor in accordance with the requirements document. The Contractor must take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. PLACE OF PERFORMANCE/ DELIVERY: The contractor shall provide the following for shipment and delivery of equipment: Timely submission of deliverables are essential to successful completing this requirement. Schedules for deliverables are specified below. WARRANTY: The contractor shall provide the standard 12- months warranty; with an option to purchase an extended warranty of 3-5 years that will cover all parts, labor, supplies, travel costs, and user support at no additional cost to the Government. INSPECTION AND ACCEPTANCE: Only the Contracting Officer (CO) and the Point of Contact (POC) has the authority to inspect, accept or reject all deliverables. All rejected deliverables will be corrected at the contractor s expense with no additional cost to the government The contractor shall provide a complete set of unabridged operator manuals, service manuals, electronic schematics, troubleshooting guides, and parts lists for each piece of equipment which is part of the system procured by the Medical Center. The contractor shall provide a complete set of manufacturer s cleaning guidelines/instruction for each system component that is used. PLACE OF PERFORMANCE/ DELIVERY: On-site delivery team to perform unpacking, uncrating, and removal of packing material, setup and inside delivery to location specified by Point of Contact or delegate. The Contractor shall Install the procurement/item to: Lubbock VA Health Clinic 3510 4th Street Lubbock, Texas 79412 Operating Room 2nd Floor HOURS OF OPERATIONS: Delivery shall be scheduled from 7:30 am - 4:00 p.m., Monday through Friday, excluding Federal Holidays. There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that VA follows: Under current definitions, four are set by date: New Year's Day January 1 Independence Day July 4 Veterans Day November 11 Christmas Day December 25 If any of the above falls on a Saturday, then Friday must be observed as a holiday. Similarly, if one falls on a Sunday, then Monday must be observed as a holiday. The other six are set by a day of the week and month: Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November Mandatory Check in/out and Removable of Media Scanning: For any services performed on-site the Contractor must, upon arrival at the Lubbock VA Health Clinic, report to the Facility POC to check in before proceeding to the any department and before performing any services. Prior to leaving the Lubbock VA Health Clinic, the Contractor must check out with the POC. This check in and check out is mandatory. Upon check in the Contractor must ensure that any removable media is scanned by the Biomedical Engineering Section prior to connecting to any Lubbock VA Health Clinic network, device or system. The Contractor must provide any removable media to Biomedical Engineering staff to perform malware/virus scan checks. The Government will not perform any virus or malware removal on the Contractor s removable media. The Contractor shall be responsible for assessing the Lubbock VA Health Clinic for all requirement cabling and other equipment needed for installation. The contractor will re-connect the new unit to the existing utilities and perform the start-up check to ensure proper function. The Contractor will consult and coordinate with the in-house engineering group to gain access to restricted areas. All installation plans will be reviewed and signed off on by the project POC and engineering representative. POINTS OF CONTACT: Anastasia Bowen, Administrative Officer (112) Surgical Service Thomas E. Creek VA Medical Center 6010 Amarillo Blvd West Amarillo, TX 79106 O: (806) 355-9703 ext. 4592 C: (806) 282-3222 E: anastasia.bowen@va.gov Operating Constraints: All installation and implementation work must be completed during regular business hours from 8:00am - 4:00 p.m., Monday through Friday, excluding Federal Holidays. Lubbock VA Health Clinic has discretion to defer/hold any installations if locations are not accessible for the installation process. Specific Tasks: The Contractor must perform the following: The Contractor must attend a Project Kickoff Meeting where the project must be discussed in detail. The meeting will be conducted by conference call and coordinated by the POC within seven (7) days after the contract award. Clinical, Surgical, and Bio-med Staff training is required onsite which will be coordinated by the POC within seven (7) days after the contract award. Salient Characteristics: SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: . This equipment will assist in providing superior care to our Veterans. This is the standard of care outside the VA and with essential features as; Must Have the below Requirements: Clinical Application. Support-IT-Clinical Training minimum 24 hrs (3 days) Weight 160 kg (353 lbs.), nominal configuration Dimensions (H × W × D) 148 cm × 115 cm × 79 cm (58.3 in × 45.2 in × 31.1 in) Power consumption 70 W, typical; max. 2.2 kW with aux power sockets in use Electrical mains connection 100 240 V~ 50/60 Hz (w/o isolation transformer) Electrical mains connection 100 127 V~ 50/60 Hz or 220 240 V~ 50/60 Hz (w isolation transformer) Maximum power consumption 12 A Integrated battery backup time 30 minutes minimum, 150 minutes typical (new and fully charged battery) Data interfaces 2 × RS 232 (MEDIBUS protocol), 1 × USB, 1 × LAN Integrated power sockets 4 × country specific (w isolation transformer) or 4 × IEC Latex Not made with natural rubber latex Drawer module(s) (optional) 3 drawers incl. 2 lockable drawers and a writing surface Ambient conditions shall include: Temperature 10 to 40°C (50 to 104°F) Air pressure 9.0 to 15.3 psi Equivalent to 4,000-meter altitude Fresh-gas delivery electronically controlled gas mixer Fresh-gas flow Off; 0.2 to 15 L/min O2-concentration 21 to 100% in Air, 25 to 100% (in N2O) O2-flush 25 to 75 L/min at 39 to 100 psi supply pressure O2-flow for auxiliary and additional oxygen Off; 2 to at least 10 L/min V Ventilator TurboVent2 (electrically driven and electronically controlled turbo ventilator) Standard modes of ventilation Manual/Spontaneous Pressure Control CMV, Pressure Control SIMV+ Volume Control CMV, Volume Control CMV/AF, Volume Control SIMV/AF Optional modes of ventilation Pressure Support, consisting of: CPAP/Pressure Support, Pressure Control SIMV+/PS and Volume Control SIMV/AF/PS Pressure Control APRV External fresh gas outlet Patient demographics Neonates, pediatrics, adults Tidal volume 20 to 2,000 ml Inspiratory pressure PINSP 3 to 80 cmH2O Pressure limitation PMAX 7 to 80 cmH2O Pressure support over PEEP 0 to 78 cmH2O Respiratory rate 3 to 100/min Inspiratory time 0.2 to 10 s Inspiratory flow 0 to 180 L/min PEEP/CPAP Off; 2 to 35 cmH2O Measurement systems displays and further functionality: 15.3" touch screen, configurable user interface, intelligent alarm management incl. remedy assistance Minute volume (MV) and tidal volume (VT); respiratory rate (RR); peak inspiratory pressure (PIP), plateau pressure (Pplat), mean airway pressure (Pmean), PEEP; compliance (C), resistance (R) Integrated gas bench for measuring inspiratory and expiratory gas concentrations of O2, N2O, CO2 and anesthetic agents (automatic detection of Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane); age corrected display of xMAC values Simultaneous display of 3 real-time curves for CO2, O2 and anesthetic agent concentrations, airway pressure, inspiratory and expiratory flow Bar graph display of volume and tidal volume; virtual flow tubes for O2, AIR, N2O Simultaneous display of 2 loops: Volume-Pressure and Flow-Volume, reference loop Graphical or tabular display of trends and mini-trends simultaneous with real time curves Low flow wizard to display fresh gas efficiency Fresh gas and anesthetic agent consumption measurement per case and per last zeroing Auto Set for alarms Device Status Panel with LC Display for airway pressure, supply status of battery and gases (CGS + cylinders) Dosing of O2 and anesthetic agents during Man/Spont ventilation possible, even without power Programmable, time-based fully automatic start-up and self-test of device and software Integrated, dimmable illumination of working and documentation surfaces, illuminated vaporizers (optional) Heated breathing system, tool-free exchangeability Must be FDA Approved Class 2 Medical Device RME must be able to be reprocessed (cleaned mechanically or by hand) utilizing facility approved enzymatic detergents and lubricant s when necessary, Steam Sterilization at typical 270-272 degree for no more than 4 minutes of exposure or hydrogen peroxide sterilization validated only by ASP Sterrad NX.