36C10G18Q0155-002.docx

Salient Characteristics (SC) Literature Review Cryotherapy Tissue Ablation System – Brand Name or Equal (BNOE) Medtronic

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires that the offeror indicate each product that is being offered as an “equal” product. For each equal product, the offeror 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 solicitation. The offeror also must clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Salient Characteristics (SC) Literature Review Cryotherapy Tissue Ablation System

SC 1 Cryotherapy Tissue Ablation System must demonstrate compliance with requirements of widely accepted product safety standards, as determined through independent testing by organizations such as the American National Standards Institute (ANSI), Underwriters Laboratories (UL), and American Section of the International Association for Testing Materials, International Electro technical Commission (IEC). Must be FDA approved.

SC 2 Cryotherapy Tissue Ablation System must have a durable solid non-absorbing, corrosion-resistant design.

SC 3 Cryotherapy Tissue Ablation System must use a minimum cord length of 8 feet and the charger must use standard electrical wall outlet - 110V-120V circuit; 120V 60Hz AC input.

SC 4 Cryotherapy Tissue Ablation System must have an integrated temperature indicator and a timer for monitoring and controlling therapy duration.

SC 5 Cryotherapy Tissue Ablation System must be able to be cleaned using hospital grade cleaning solutions. Surfaces must be nonabsorbent. Vendor must provide manufacturer-cleaning guidelines.