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Maintaining Device Effectiveness
Device Storage
FOR SINGLE USE ONLY.
Do not resterilize and re-implant explanted pulse generators.
St. Jude Medical has sterilized the pulse generator with ethylene oxide prior to shipment. Contact
St. Jude Medical if resterilization is necessary.
Do not implant the device when:
It has been dropped on a hard surface because this could have damaged pulse generator
components.
The sterility indicator within the inner package is purple, because it might not have been sterilized.
Its storage package has been pierced or altered, because this could have rendered it non-sterile.
It has been stored or transported outside the environmental temperature limits.
Storage limits: 10° to 45°C.
Transportation limits: -20° to 60°C.
An electrical reset condition may occur at temperatures below -20°C.
After cold storage, allow the device to reach room temperature before charging the capacitors,
programming, or implanting the device because cold temperature may affect initial device
function.
Its "use before" date has expired, because this can adversely affect pulse generator longevity or
