ATTACHMENT B - MINIMUM SALIENT CHARACTERISTICS_PRODUCT DESCRIPTION.pdf

PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Ellex, Inc. Ultra Q™ Brand Name or Equal Ophthalmic Q-Switched ND YAG Laser System

Prepared By:

Strategic Acquisition Center

Department of Veterans Affairs 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Ophthalmic Q-Switched ND YAG Laser System product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

Surgical lasers are used to create surgical incisions, excise or vaporize deeper tissue, coagulate bleeding vessels, and vaporize surface anomalies, in either open or endoscopic surgeries, depending on the device's capabilities. They may be used for general surgery, gynecology, urology, ophthalmology, dermatology, and a wide variety of other surgical specialties.

Surgical lasers provide one or more laser outputs that can be used to vaporize, cut, or coagulate tissue in surgery. Their output modes include continuous and pulsed energy delivery. They utilize one or more lasing mediums that output different wavelengths and have a variety of delivery systems that alter the effects of lasers on tissue.

Q-Switched YAG Laser:

Q-switched Nd: YAG (neodymium: yttrium-aluminum-garnet or “YAG”), is a family of solid-state lasers that contain the doping element neodymium and emits wavelengths of 1,064 nm. The laser energy is not preferentially absorbed by water or hemoglobin compared to other lasing medium types. As such, this wavelength penetrates more deeply into tissue, with maximal penetration of up to 10 mm and produces either a photo disruptive or a photothermal effect. Nd: YAG wavelengths can be transmitted through a biomicroscope or through optical fibers for endoscopic applications. These wavelengths can also pass through clear fluids, unpigmented tissue, and the top layer of skin, making Nd: YAG lasers more effective than others in treating certain medical conditions.

In Ophthalmology, the YAG laser is the laser used to open an opacified posterior capsule after cataract surgery. YAG laser capsulotomy is performed utilizing a biomicroscope. During YAG laser capsulotomy, the ophthalmologist may use a contact lens to help focus the laser energy at the level of the lens capsule, stabilize the eye and improve the laser beam optics.

The YAG laser also is used to create an opening in the iris (iridotomy) in cases of narrow or closed anterior chamber angles.

The Vendor must demonstrate the ability to meet all requirements of the solicitation.

The objective is to provide Ophthalmic Q-Switched ND YAG Laser Systems to be used by Ophthalmologists throughout the VA medical centers and facilities.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the vendor indicate that each product being offered is an “equal” product to the Ellex, Inc. Ultra Q™ Ophthalmic Q-switch ND YAG Laser Systems. For each equal product, the vendor must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The vendor must also clearly identify the item by brand name (if any) and make/model number. Finally, 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, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Contract

Line Items

Manufacturer Part Number Description

0001 Ellex, Inc. ULTRAQ Ultra Q™ Laser

0002 Ellex, Inc. V-BASE-MT V-Base Mobile Table

The Department of Veterans Affairs (VA) is seeking vendors who can provide Ellex, Inc.

Ultra Q™ Ophthalmic Q-Switched ND YAG Laser System as listed above or equal commodities which meet all the following salient characteristics:

CLIN 0001

ULTRA Q™ LASER

PART NUMBER: ULTRAQ

SC #

SALIENT

CHARACTERISTICS

METHOD OF

EVALUATION

LOCATION IN

LITERATURE

SC 1

Must be a Q-switched Nd:YAG Laser System

Literature Review

SC 2

Must deliver a wavelength of 1064 nm

Literature Review

SC 3

Must have a Burst Mode of 1, 2 and 3 pulses per trigger

Literature Review

SC 4

Must have a minimum spot size of 8 um

Literature Review

SC 5

Must have an Energy Per Pulse (or Output Energy) range of at least 0.3-10 mj/pulse

SC 6

Must have a minimum Pulse Repetition Frequency of 2.5 Hz

Literature Review

SC 7

Must have a minimum Pulse Duration or Pulse Width of ≤ 4 ns

SC 8

Must achieve minimum 1.6 mj plasma threshold in air.

Literature Review

SC 9

Must be able to shift the laser focal point up to 350 µm