Inactive
Notice ID:N626450R0034
The system shall be a suspended body and face shield radiation protection device that provides radiation shielding to a clinician from the top of the head down to the calves. The system shall be a fre...
The system shall be a suspended body and face shield radiation protection device that provides radiation shielding to a clinician from the top of the head down to the calves. The system shall be a free-standing overhead motion system. The system shall include a lead-acrylic transparent face shield and arm flap shields. The body apron with arm flap shields shall have a lead equivalency of up to 1 mm and the head shield shall have a lead equivalency of up to 0.5 mm. The system shall allow the operator to maintain freedom of motion in all three spatial axes and range of arm motion during procedures. Each system shall include install. 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.