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STATEMENT OF WORK GENERAL SCOPE Microwave Ablation system Brand Name or Equal Brand: Neuwave Part Number: NWC1US1N 1.0 General 1.1 Objective Provide a Microwave ablation unit with a 2450 MHz generator... STATEMENT OF WORK GENERAL SCOPE Microwave Ablation system Brand Name or Equal Brand: Neuwave Part Number: NWC1US1N 1.0 General 1.1 Objective Provide a Microwave ablation unit with a 2450 MHz generator that can perform ablation in a variety of lesions and tumors including liver, lung, kidney and bone tumors. Must include energy control to help protect non-targeted anatomy. Must have the ability to use multiple probes to address various types of lesions and their sizes. 1.2 Scope of Work 1.3 Technical Salient Characteristics: Combined Thermal and Non-thermal ablation system (Microwave, RadioFrequency, Cool frequency, and chemical ablation procedures) Reduce destruction of tissue by extreme hyperthermia (elevated tissue temperatures) or hypothermia (depressed tissue temperatures), and reduce interference with implanted in non-targeted tissue areas Multiple operating conditions (type of target tissue, type and dose of energy administered, method and duration of energy output) At least 3 Radiofrequency output modes for Auto, temp, and manual Radiofrequency Ablation equipment requires flow of electric charge that periodically reverses indefinity at radio frequencies no higher than 450kHz Equipment must treat multiple percutaneous and surgical lesions. Microwave Ablation equipment requires frequency as low as 300MHz and as high as 300 GHz At least 2 Microwave power modes Manual and intermittent Needs auto cauterization probes At least 2450 MHz Industrial Solid State Microwave Generator Software compatible/interface with existing VA Vista (indicate in quote) Onsite minimum 3 days technologist training and webinar video training (indicate in quote) Warranty at least 2 years (provide warranty copy) Equipment must conform Digital Imaging and Communication in Medicine Standard (provide proof). All equipment and software fully operational after Complete install of equipment by required delivery date Vendor must certify ability to meet delivery date of 100 days ARO Vendor to provide before and after hour help desk support phone number, field locations, remote phone number, and email for potential issues related to operation and install equipment and software. 1.4 Ablation System Technical Requirements Ablation system than provides cryoablation, percutaneous ethanol injection (PEI), irreversible electroporation, TACE trans-arterial chemoembolization, HIFU high-intensity focused ultrasound Control of necrosis pattern i.e. shape and size of the ablated volume, ability to set operating conditions (type of target tissue, type and dose of energy administered, method and duration of energy output) Shapability of thermal lesion Coagulation performance Ability to preserve tissue around the target with a lack of interference with implanted medical devices or prostheses. Provide Radiofrequency Thermal Ablation of alternating electric currents at radio frequencies up to 450kHz. Must have at least three radiofrequency energy output modes: Auto (power regulated automatically according to impedance), Manual (preset power output) and Temp (power regulated automatically according to the temperature set) Provide Microwave Thermal Ablation at a frequency of between 300MHz and 300 GHz with both Manual (Continuous power deliver) and Pulsed (intermittent power delivery) Provide automatic procedure for cauterizing the applicator entry path at the end of treatment (track ablation) Have at least a 2450 MHz generator. 2.0 Training Technologist Training: Go-Live onsite Applications Training (minimum 3 days) to be used for technologists Support and other Documentation to Provide: Provide DICOM Conformance Statement if applicable Provide completed Pre-procurement Assessment form (6550) and MDS2 document if applicable Provide information about your company s applications and technical support structure during the warranty period (i.e. a listing of Field Service Engineer locations and availability, support 800 phone number(s), remote support, etc.) Provide information about your company s applications and technical support structure during after the warranty period (i.e. a listing of Field Service Engineer locations and availability, support 800 phone number(s), remote support, etc.) 2.1 Evaluations Factors Technical: Acceptable-Vendor Product must meet all technical requirements 1-17 listed in SOW to include (warranty, model, part number, and product literature). Unacceptable/non-responsive- Vendor s product/offer does not meet all technical requirements 1-17 to include (missing warranty, model, part number, product literature. Distribution letter: Acceptable-Vendor must provide signed authorized manufacturer letter to authorized distribute. Unacceptable/non-responsive- Vendor is not manufacturer and vendor does not provide from manufacturer a signed authorization to distribute letter. Price: Acceptable Lowest price that meets technical and letter requirements and is the lowest quote. Unacceptable/non-responsive- Vendor product fails to meet all technical, letter requirements, and is not the lowest price quote. This requirement will be IAW Brand Name or Equal product descriptions, which requires that the Respondent indicate each product that is being offered as an equal product to the illustrative of (Neuwave Ablation System list part number (NWC1IS1N) where applicable. For each equal product, the Respondent must include a description reflecting the characteristics and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the Brand Name or Equal product requirements. The Respondent must also clearly identify the item by brand name (if any) and make/model number. Finally, the Respondent must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information for the Planners consideration, and clearly describe any modifications it plans to make to a product to make it conform to the or equal product requirements.