6515--Dry Eye Treatment System

In accordance with RFO FAR 5.101, this Presolicitation Notice is issued to inform potential vendors that a solicitation for the Treatment of Dry Eyes will be posted to the government point of entry within the next ten days.

All responsible sources may submit a quotation, in accordance with the Request for Quotes (RFQ) requirements, which will be considered by the agency.

Vendors are notified that One or more of the items under this acquisition is subject to Free Trade Agreements.

Please see RFQ 36C24226Q0710, once posted for further information and submission instructions.

STATEMENT OF NEED

Coatesville Veterans Affairs Medical Center (VAMC)

Optometry Department

Treatment Modality for Management of Ocular Surface and Eyelid Disease

DESCRIPTION:

The Optometry Department of Coatesville VA Medical Center (VAMC) requires a device specifically designed to address ocular surface and eyelid diseases, such as dry eye syndrome, meibomian gland disease, blepharitis, Acne Rosacea, and related skin conditions around the eyes. The required technology must utilize dual frequency monopolar Radio Frequency (RF) and electronic dynamic muscle stimulation (DMS) to deliver heat and muscle stimulation at varying tissue depths. This modality aims to increase blood circulation, enhance meibomian gland function, improve muscle tone, and boost blinking efficiency, thereby providing relief for patients with these conditions.

The device must employ monopolar RF technology, which is essential as it reduces the risk of electrical arcing and ensures rapid, uniform heating of deeper eyelid tissues.

Dual frequency RF technology is necessary because it does not cause skin depigmentation and is not contraindicated for any patient population. This feature allows for more aggressive management of dry eye in all veterans at Coatesville. Treatments with this technology enhance blood circulation, stimulate collagen production, and support meibomian gland function. Treatments enhance blood circulation, stimulate collagen production, and provide meibomian gland function.

Dynamic muscle stimulation is also required for mechanical, non-invasive correction of eyelid muscle tone to restore normal function. Abnormal eyelid function increases the risk of corneal surface irregularities, epithelial breakdown, and permanent vision loss. Dynamic muscle stimulation uses controlled electrical pulses to reactivate and restore resting muscle tone in the orbicularis oculi. These treatments improve blinking efficiency, stabilize the natural tear film, protect the cornea from progressive exposure damage, and reduce the need for daily home care.

SCOPE:

The contractor shall provide a new FDA approved Monopolar Dual Frequency RF with Electronic Dynamic Muscle Stimulation. The device must be able to treat patients of all skin tones for dry eye syndrome, meibomian gland disease, blepharitis, Acne Rosacea, and conditions affecting the skin around the eyes. All minimum salient characteristics must be met.

The Lumenis BE OptiLift System is a Brand Name Product provided for reference comparable salient characteristics only; no brand-name requirement is intended.

SALIENT CHARACTERISTICS

FDA-approved specifically for ophthalmic and optometric use

Clinically validated for treatment of all scope diagnoses

Monopolar Application

Utilizes dual frequency technology

Utilizes electronic dynamic muscle stimulation

Multiple RF frequencies capable of tailoring depth and intensity of treatments to specific skin thickness and patient needs

Non-pigment dependent system

No required anesthesia, topical numbing creams, injections, or eye drops

Zero post-procedure downtime

Touch screen display

Rounded electrode contoured for eyes to maximize patient safety and comfort

Automatic treatment presets

DELIVERY REQUIREMENTS:

Supplier shall perform all required assembly in accordance with the manufacturers instructions.

Supplier shall inspect to ensure that the system is clean, has no scratches and that the installation is complete and ready for patient use. The vender will provide on-site training to staff.

Vendor shall remove all trash, cartons, debris, and must provide and execute a recycling plan for cartons and cardboard disposal.

Vendor shall be responsible for delivery, assembly/installation, and training during normal business hours Monday-Friday 7:30 am to 4:30 pm, excluding any declared Federal Holidays.

Scheduling for delivery shall be coordinated at least 7 business days prior to shipment.