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The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood components to inactivate leukocytes and lymphocytes.

The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models. The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the "start" button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message "cycle completed OK." is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.