6650--Scanning Systems: Laser: Optical Biometry

REQUEST FOR INFORMATION

This RFI is being sent solely for information and planning purposes and does not constitute a solicitation or obligation on the part of the Government. Per FAR 15.201(e), responses to this notice are not considered offers, shall not be used as a proposal, and cannot be accepted by the Government to form a binding contract. Neither unsolicited proposals nor any other kinds of offers will be considered in response to this notice. No evaluation letters and/or results will be issued to the respondents; however, the Government does reserve the right to contact any respondent and/or respondent reference to obtain additional information. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. Any resulting procurement action will be the subject of a separate, future announcement. The information is provided for discussion purposes and any potential strategy for this acquisition may change prior to any solicitation release. The acquisition strategy, evaluation methodology, contract type, and any other acquisition decisions are to be determined.

The Department of Veteran Affairs located at Huntington VAMC located at 150 Spring Valley Dr., Huntington, WV 25704 is seeking a Scanning System: Laser: Optical Biometry.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510- Electromedical and Electrotherapeutic Apparatus Manufacturing, size standard is 1,250 employees.

Salient Characteristics:

Perform accurate biometry, keratometry and intraocular calculations including toric lenses, especially in difficult cataract cases.

Measurements must be obtained via non-contact.

Measurements obtained via two-dimensional swept-source OCT (SS-OCT).

Must have ability to obtain biometry readings on dense cataracts.

Automated data transfer:

Must be capable of seamlessly integrating with ophthalmic data management systems already in place to eliminate manual data entry errors. The data management system in place is the ZEISS FORUM.

Must be capable of transferring data via ZEISS FORUM into the biometry unit and vice versa.

DICOM compatibility:

Must be DICOM-compliant to interface with electronic medical record systems i.e. VISTA.

Physical and Operational Requirements

Must have a compact and ergonomical design.

Must include patient positioning features.

Adjustable chin rest.

Head support for stable measurements.

Must be compatible with standard U.S. electrical outlets.

Must be FDA-approved for use in ophthalmic biometry and comply with ISO standards for medical devices.

Responses:

The response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

Vendor are requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

Full name and address of company

DUNS number/ CAGE Code/ SAM UIE

Business Size

Manufacturer or Distributor

If distributor provide full name, business size and address of manufacturer.

Country of Origin designation for all products MUST COMPLETE THIS SECTION

Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met.

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Authorized Distributor Letter Certified by OEM with a current date.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.