1 High Rubidium-82 (Rb-82) yield with minimal residual Sr-82/Sr-85 breakthrough 2 Must consistently provide sufficient activity and elution efficiency with short elution time (<70 seconds) to maximize workflow efficiency and reduce patient preparation time 3 Must meet or exceed U.S. Pharmacopeia (USP) and FDG standards with the minimal breakthrough of Strontium-82 and Strontium-85 (Sr-82/Sr-85 <0.02 uCi/mCi of Rb-82 at the time of administration) 4 Integrated system to measure and report Sr-82/Sr-85 breakthrough with automated alerts if thresholds are exceeded 5 Adequate built-in radiation shielding, safe waste management system, integrated dose calibrator, and automatic error detection for malfunctions, low-yields, and contamination 6 Compact design suitable for installation in PET imaging suites that operate on standard power outlets in the United States at 120V 7 Efficient Rb-82 generator that provides consistent and accurate performance for 6-weeks 8 Must comply with all the FDA, USP, NRC, and ISO regulatory and certification requirements for medical devices and radioactive materials 9 Assurance of consistent generator availability and timely replacements every 6 weeks 10 Any/all new upgrades to the hardware/software/firmware will be included/provided each time the generator is replaced.
