The Naval Medical Logistics Command has a requirement for one (1) camera, photographic, ophthalmic, photographic, fundus, mydriatic [23-485] for U.S. Naval Hospital (USNH) Okinawa.

The fundus, ophthalmic, mydriatic, photographic camera shall be capable of examining the retinas of neonatal patients (i.e. pre-mature infants) for retinal abnormalities (i.e. vascular, developmental) and neonatal vascular retinopathies, specifically retinopathy of prematurity (ROP). The ophthalmic camera shall be capable of capturing images of ROP in patients cared for in the neonatal intensive care unit (NICU). The ophthalmic camera shall include fluorescein angiography (FA) capability for ROP imaging. The ophthalmic camera, including the FA capability, shall have clearance/approval by the U.S. Food and Drug Administration (FDA). Additionally, the solution shall be comprised of a mobile central processing unit (CPU), display screen, ophthalmic camera, tri-function footswitch, and a 130o field of view ROP lens for retinal visualization. Also, the requirement shall include installation and operator training for the ophthalmic camera. The power requirements are 120 VAC, 50/60 Hz.

In addition, 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 an 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 system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.