36C10G18Q0117-004.docx

Brymill Brand Cryosurgical Units or Equal

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

VENDORS SUBMITTING AN "OR EQUAL" QUOTE MUST MEET ALL THE MINIMUM SALIENT CHARACTERISTICS LISTED BELOW.

Minimum Salient Characteristics (SC) for the Cryosurgical Units (Literature Review)

SC1 Cryosurgical Units must provide an accurate, consistent and a controlled-flow application of liquid nitrogen treatment to destroy or remove dermatology related skin lesions by freezing.

SC2 Cryosurgical Units must be compliant with the International Organization for Standardization (ISO), ISO 9001 and ISO 13485.

SC3 Cryosurgical Units must be approved by the Federal Drug Administration (FDA) FDA regulation 878.4350.

SC4 Cryosurgical units must provide appropriate safety features to include relief valve, trigger feature with automatic shut-off, vacuum design to eliminate exterior freezing of the bottle.

SC5 Cryosurgical Units must be portable, hand-held, and 1lb or less with a fingertip trigger that is user-friendly for both right-handed and left-handed users.

SC6 Cryosurgical Units must be corrosion-resistant and must be able to be cleaned using hospital grade cleaning solutions such as Sani-Cloth disposable wipes and peroxide. Surface must be non-porous and nonabsorbent. Surface material must be able to tolerate a cleaning between each patient.

SC7 Cryosurgical units must provide a variety of straight spray tips and bent spray tips with apertures of various sizes.

SC8 Two (2) Operator manuals/CDs must be provided for each Cryotherapy Unit

SC9 Cryosurgical Unit B-700 must have a minimum capacity to contain of 16 fluid ounces of liquid nitrogen

SC10 Cryosurgical Unit B-800 must have a minimum capacity to contain of 10 fluid ounces of liquid nitrogen