9
Sterilization, Storage and Handling
Sterilization, Storage and Handling
Sterilization, Storage and Handling
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 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
Follow
Follow
Follow----up Testing
up Testing
up Testing
up Testing
Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation
(CPR) are present during post-implant device testing should the patient require external rescue.
