User Manual

Lumax Technical Manual 149
3. Sterilization and Storage
The ICD/CRT-D is shipped in a storage box, equipped with a
quality control seal and product information label. The label
contains the model specifications, technical data, serial number,
use before date, as well as sterilization and storage information.
The ICD/CRT-D and its accessories have been sealed in a
container and gas sterilized with ethylene oxide. To assure
sterility, the container should be checked for integrity prior to
opening.
CAUTION
Device Packaging - Do not use the device if the device’s
packaging is wet, punctured, opened or damaged because
the integrity of the sterile packaging may be compromised.
Return the device to BIOTRONIK.
Re-sterilization - Do not re-sterilize and re-implant
explanted devices.
Storage (temperature) - Store the device between 5° to
45°C (41° - 113° F) because temperatures outside this range
could damage the device.
Storage (magnets) - To avoid damage to the device, store
the device in a clean area, away from magnets, kits
containing magnets, and sources of electromagnetic
interference (EMI).
Temperature Stabilization - Allow the device to reach room
temperature before programming or implanting the device
because temperature extremes may affect initial device
function.
Use Before Date - Do not implant the device after the USE
BEFORE DATE because the device may have reduced
longevity.