MODIFICATION
65 -- Ophthalmoscope, scanning laser
- Notice Date
- 4/16/2021 6:41:57 AM
- Notice Type
- Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- NAVAL MEDICAL LOGISTICS COMMAND FORT DETRICK MD 21702-9203 USA
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264521Q0022
- Response Due
- 4/17/2021 7:00:00 AM
- Archive Date
- 05/02/2021
- Point of Contact
- Gerrie M. Johnson
- E-Mail Address
-
gerrie.m.johnson.civ@mail.mil
(gerrie.m.johnson.civ@mail.mil)
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (FAR� 13.106-1(b)(1)), soliciting from a single source. The proposed source is Melling, LLC (dba MellingMedical), 658 South Columbus Street, Alexandra, VA 22314. United States Naval Hospital (USNH) Yokosuka has a requirement for one (1) ophthalmoscope, scanning laser [18-190]. The ophthalmoscope shall be able to scan the retina to assess retinal health of adult eyes. The ophthalmoscope shall be able to complete a retinal scan of the eye through a non-mydriatic, non-dilated pupil in less than one minute. The unit shall be capable of scanning a non-dilated pupil with a minimum diameter of 2 mm. The ophthalmoscope shall be capable of scanning a minimum of 200 degrees of the retina in a single panoramic capture. The unit shall be capable of performing iris detection. The ophthalmoscope shall be capable of various wavelengths for different visual depths in order to assess retinal health. The unit shall be capable of viewing the sensory retina to the retinal pigment epithelial (RPE) at a 532 nm wavelength. The unit shall be capable of viewing a deeper depth at 635 nm wavelength that views the RPE to the Choroid. The unit shall be capable of viewing the eye structures at these specific wavelengths to characterize degeneration, diseases, and deterioration to the retina. The unit shall be capable of various procedures including, but not limited to, imaging in color, red-free, and autofluorescence. The electrical requirement for the system is 120 VAC, 60 Hz. The unit shall operate on a DOD supported operating system (OS).� The vendor shall provide two (2) operators manuals and two (2) service manuals, each in English. The instrument shall support the Integrating the Healthcare Enterprise (IHE) Eye Care Workflow Integration Profile as an Acquisition Modality Actor with the Patient Instructions Option.� The instrument shall support the IHE Eye Care Workflow Integration Profile as an Acquisition Modality with the Relative Image Position Coding Option.� The instrument shall send DICOM images to the Eye Care PACS.� The instrument DICOM shall not be proprietary. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM.� All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States.� The claims made for the product shall comply with the regulations of the FDA, with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.� The system shall be installed in compliance with OSHA requirements. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/ec7f178cc7bf4d16bbb6ef34a9c33711/view)
- Place of Performance
- Address: JPN
- Country: JPN
- Country: JPN
- Record
- SN05974529-F 20210418/210416230111 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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