15
MR environment is not determined. For more information, please consult the MRI Procedure
Information document.
Sterilization, Storage and Handling
Resterilization.
Do not resterilize and re-implant explanted pulse generators.
Use before date.
Do not implant the device after the "use before" date because the battery may have
reduced longevity.
If package is damaged.
Do not use the device or accessories if the packaging is wet, punctured,
opened or damaged because the integrity of the sterile packaging may be compromised. Return the
device to St. Jude Medical.
Device storage.
Store the device in a clean area, away from magnets, kits containing magnets, and
sources of electromagnetic interference (page 20) to avoid device damage. Store the device between
10° and 45°C because temperatures outside this range may damage the device.
Temperature Equilibration.
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.
Follow-up Testing
Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation
