Packaging system for sterile transfer of non-sterile battery

A medical device packaging system comprising:

• an outer package comprising:
• an entire medical device;
• a sterile tray assembly having a first sterile side, a second sterile side, a first sterile barrier comprising a sterile tray between the first and second sterile side and a second sterile barrier, the second sterile barrier being releasable over the second sterile side;
• wherein the first sterile side, the second sterile side, the first sterile barrier and the second sterile barrier are all sterile when removed from the outer package,
• wherein the first sterile side comprises a first sterile controlled zone within the tray assembly that is sterile when removed from the outer package and remains sterile when transferred to a surgical operating field,
• wherein the second sterile side comprises a second controlled zone within the tray assembly that is initially sterile when removed from the outer package and later becomes a non-sterile controlled zone after releasing the second sterile barrier following insertion of a non-sterile battery into an originally sterile interior battery compartment within the second controlled zone;
• wherein the first sterile side of said sterile tray assembly is releasably secured to a proximal exterior portion of the entire sterile medical device having a sterile device body, a sterile proximal battery housing, a sterile handle;
• and a sterile battery compartment cover in the first sterile controlled zone, and
• wherein the originally sterile interior battery compartment of the proximal battery housing is accessible in the second controlled zone through an opening in the second sterile barrier and a first opening in the sterile tray over an opening in the internal sterile battery compartment of the proximal battery housing, such that a sterile person can handle the entire sterile medical device with the tray assembly in a vertical orientation from the first sterile side of the sterile tray assembly within the sterile operating field and present it the internal sterile battery compartment of the proximal battery housing to a non-sterile person in a controlled manner from within the sterile operating field,
• wherein said non-sterile person can insert a non-sterile battery through the opening in the second sterile barrier and the first opening in the first sterile barrier into the internal sterile battery compartment of the proximal battery housing from an area outside of the sterile operating field, thus making the internal battery compartment non-sterile, while the proximal exterior portion of the entire sterile medical device remains isolated and sterile behind the first sterility barrier on the first side of the tray assembly, and
• wherein the second sterile barrier can then be released from over the second sterile side to expose a second opening proximal to the first opening in the first sterile barrier of the sterile tray assembly.