The vendor shall provide a blood product irradiator with the following minimum physical, functional and performance characteristics: (a) The irradiator must be
designed and FDA 510(k) approved as a medical device to irradiate blood components to prevent Transfusion Associated - Graft Versus Host Disease (TAGVHD), (b) The irradiator must deliver a dose of irradiation of 2500 cGy (25 Gy) targeted to the central portion of the blood product container and 1500 cGy (15 Gy) should be the minimum dose at any other point. This must be confirmed with dosimetry testing at the time of installation and six (6) months after installation, (c) The irradiation source of the irradiator should be by X-ray tubes and not contain radioactive source material (e.g., cesium-137 or cobalt-60), (d) The irradiator must
weigh no more than 2,200 pounds (1,000Kg) in order to comply with the facility's weight-bearing load limitations.

The vendor shall provide annual servicing of this equipment for a period of five (5) years.

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