Analysis of the generator was completed and proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.706 volts, shows an ifi=yes condition.There were no performance or any other type of adverse conditions found with the pulse generator.
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