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STATEMENT OF NEED Pulmonary Function Testing Body Box Background. The current body box system used at the Pittsburgh VA Healthcare System is past the life cycle expectation. The system is beginning to... STATEMENT OF NEED Pulmonary Function Testing Body Box Background. The current body box system used at the Pittsburgh VA Healthcare System is past the life cycle expectation. The system is beginning to fail on a regular basis. Due to COVID 19, it is increasingly important to have reliable pulmonary function testing (PFT) equipment as COVID 19 can cause sever damage to the patient s respiratory system. A newer system will increase the reliability of available equipment when needed. The current system is outdated and upgraded equipment will be an improvement to patient care. In a traditional plethysmograph (or "body box"), the patient, is placed inside a sealed chamber the size of a small telephone booth with a single mouthpiece. At the end of normal expiration, the mouthpiece is closed. The patient is then asked to make an inspiratory effort. As the patient tries to inhale (a maneuver which looks and feels like panting), the lungs expand, decreasing pressure within the lungs and increasing lung volume. This, in turn, increases the pressure within the box since it is a closed system and the volume of the box compartment has decreased to accommodate the new volume of the subject. Scope. The following items are being requested by the Pittsburgh VA Medical Center. These items will meet the minimum needs of the facility. Description Qty Characteristics Body Plethysmograph with Real Time Diffusion 1 Clear Plethysmograph Chamber with Spirometry, Thoracic Gas Volumes, Airways Resistance, Nitrogen Washout & Real Time Diffusion Capacity. Compact foot print of no more than 4ft x 4ft Desk 1 To hold monitor and printer max 2ft x 3ft Environment Monitor 1 Environment Monitor (temp, humidity and pressure) & Interface Cable Printer 1 InkJet Bronchial Provocation 1 Software Pulmonary Consult 1 Software Operator Training 1 To be provided to no less than 4 people Mobile Ultima PF System 1 Must include Spirometry, Real Time Diffusion Capacity, Nitrogen Washout, Respiratory Mechanics, Single Breath Nitrogen, Trending, Software Security Option, User Defined Predicteds, Windows 10 Pro All-In-One Computer, Computer Upgrade 1 At least 23 screen, color Printer 1 InkJet Bronchial Provocation 1 Software Pulmonary Consult 1 Software Operator Training 1 To be provide to no less than 4 people Resmon Pro FOT 1 external power supply (100-240v), Desk 1 Max size 2ft x 3ft, to hold monitor and printer Multi User 1 Must have multi user capability Computer 1 Dell 23" Windows 10 Pro 64-Bit All-In-One Computer Printer 1 InkJet Operator Training 1 To be provided to no less than 4 people 3. Specific Tasks. 3.1 Task 1 Delivery The vendor will deliver the above items to the Pittsburgh VA University Drive campus. The equipment will be delivered to the facility: Pittsburgh VA Healthcare System University Dr Pittsburgh, PA 15240 3.2 Task 2. Installation and Assembly The vendor will provide any equipment needed for proper assembly of the equipment. This includes any uncrating, assembling, and installation of components. Installation will also include testing the equipment. Testing shall include any tasks determined by the contractor to be necessary to ensure the machines are free of craftsmanship defects, all component parts are functioning within manufacturer s specification. Biomedical Engineering staff will determine if testing results are satisfactory to begin internal acceptance and fit for use. 4. Deliverables: Installation and assembly of equipment will be complete and approved for use by the vendor, the medical staff, biomed, and any other applicable groups. Contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. used on this project. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without SDS sheets. All instructions for use shall be followed. Products will not be used until SDS's are submitted to the COR. The contractor shall maintain a current, green in color, loose-leaf notebook on the job site at all times, which is readily available for viewing by the COR or VA Safety Officer. 5. Performance Monitoring The facility point of contact will monitor the successful delivery of the equipment by maintaining contact with the vendor and coordinating with the VA and Biomedical Engineering personnel. The facility point of contact will also ensure the equipment is assembled and all installation of hardware and software is done to contract specifications. 6. Security Requirements The contractor will have access to the PFT Lab to deliver the units and to perform applications training on the equipment. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). There will be no Government-Furnished Equipment or Government furnished Information provided to the vendor. 8. Other Pertinent Information or Special Considerations. a. Identification of Possible Follow-on Work. Possible follow-on work could be contact with the Vendor for troubleshooting problems. Also, vendor may be notified if the product is not functioning properly. b. Identification of Potential Conflicts of Interest (COI). There are no known potential conflicts of interest. c. Identification of Non-Disclosure Requirements. The vendor will not have access to proprietary information during the installation of the equipment. d. Packaging, Packing and Shipping Instructions. Packaging and shipping will be at the discretion of the vendor e. Inspection and Acceptance Criteria. Products will be inspected upon arrival by the COR, Biomedical Engineering and Medicine Service. 9. Risk Control Personnel will follow any safety recommendations given by the vendor for the equipment. 10. Place of Performance. Pittsburgh VA Healthcare System University Dr Pittsburgh, PA 15240 11. Delivery Schedule. The items listed above shall be delivered to the Pittsburgh VA Healthcare System, University Drive campus once the purchase has been finalized. 12. Evaluation Team Dr. Sharon Camhi and Michelle Welsbacher 13. COVID-19 Related Policies Upon entering VAPHS, 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 VAPHS. 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.