Inactive

Scope: The Buffalo VAMC is seeking to procure one (1) new Emprint HD Ablation System with ancillary components to meet the demand for these medical procedures. The proposed Emprint Ablation System sha... Scope: The Buffalo VAMC is seeking to procure one (1) new Emprint HD Ablation System with ancillary components to meet the demand for these medical procedures. The proposed Emprint Ablation System shall have FDA clearance for utilization in the United States of America. Specific Technical Elements: The proposed Emprint HD Ablation System shall meet the following Buffalo VA Medical Center technical requirements. *Offering vendors shall provide complete, detailed responses to each of the following Terms and Conditions in their bid proposals. 1 The proposed Emprint HD Ablation System shall include Thermosphere Technology. 2 The proposed Emprint HD Ablation System shall produce reliable large spherical zones of ablation rely on three types of energy control, (thermal, field and wavelength control). 3 The proposed Emprint HD Ablation System shall be capable of performing microwave ablation for the kidney, lung, and liver. 4 The proposed Emprint HD Ablation System must include its own standalone cart creating a mobile unit to be stored and wheeled to different areas of the OR. 5 The offering vendor shall provide details of the proposed Emprint HD Ablation System clinical and technical alarms. 6 The offering vendor shall confirm that the performance of the Emprint HD Ablation System shall not be affected by EMI radiated or conducted through the power lines from another device. 7 The offering vendor certifies that the proposed Emprint HD Ablation System shall withstand normal hospital power interruptions, including generator testing, without manual intervention and that normal device operation will be restored automatically, without loss of data, once power is restored. The offering vendor shall specify and provide power conditioning if required. 8 The offering vendor certified that operator safety and system performance should not be adversely affected by fluid spills. 9 Switches and controls of the proposed Emprint HD Ablation System should be protected against accidental setting changes (e.g., due to someone brushing against the panel / screen). Device design should prevent misinterpretation of displays and control settings. The controls (i.e., switches, knobs, etc.) should be visible and clearly identified, and their functions should be self-evident. Terms and Conditions: The offering vendor shall meet the following Buffalo VA Medical Center Terms and Conditions. *Offering vendors shall provide complete, detailed responses to each of the following Terms and Conditions in their bid proposals. 1 Cleaning and disinfecting protocols for the proposed Emprint HD Ablation System units shall be provided and demonstrated to staff by the offering vendor. A list of acceptable cleaning and disinfecting chemistries shall be included with the purchase of the proposed Integrated Flow device. 2 The offering vendor shall provide two copies of all service literature, including any necessary service and maintenance software, keys, and or passwords (in accordance with: 21-CFR 820.170(a), NFPA99 (2012 edition) Chapter 10.5.3, VAAR 852.211-70, and the VA NAC AS3000 clause). 3 The offering vendor shall provide On-Site Operator (End-User) Training for the proposed Emprint HD Ablation System. The On-Site Operator Training shall instruct clinical operators how to properly utilize the proposed Emprint HD Ablation System. The On-Site Operator Training to be provided shall be coordinated with the Buffalo VAMC Surgical Department. 4 The offering vendor shall disclose the preventive maintenance requirements for the proposed Emprint HD Ablation System (including required inspections, device testing protocols, and necessary time/ frequency dependent part replacements). 5 A standard, 1-year warranty shall be included with the bid proposal. Other warranty options may be detailed (offering vendors not required to do so) but should only be listed as potential options in the bid proposal. 6 Delivery of the proposed Emprint HD Ablation System shall be coordinated with the Contracting Officer (CO) and Contracting Officer Technical Representative (COTR).