remote possibility for a device to intermiently oversense while the CT scanning beam is directly over the
implanted device.
Sterilizaon
▪ The package contents have been sterilized with ethylene oxide before shipment. This device is FOR▪
SINGLE USE ONLY and is not intended to be resterilized.
▪ Do not implant the device when the sterility indicator within the inner package is purple, because it might▪
not have been sterilized, or when the storage package has been pierced or altered, because this could
have rendered it non‑sterile.
Storage and Handling
▪
Store the device at temperatures between 15°C (59°F) and 30°C (86°F). During transportaon and▪
handling the device can be exposed to temperature excursions between ‑20°C and 60°C (-4°F and 140°F).
▪ Store the device in a clean area, away from magnets, kits containing magnets, and sources of
▪
electromagnec interference to avoid device damage.
▪ Do not implant a device that has been dropped on a hard surface while outside of its intact shelf package,▪
or from a height of more than 61 cm (24 in.) while within its intact shelf package. Sterility, integrity, or
funcon cannot be guaranteed under these condions, and the device should be returned to
Abbo
Medical
for inspecon.
▪ Aer cold storage, allow the device to reach room temperature before programming or implanng the▪
device because cold temperature may aect inial device funcon.
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