User's Manual

US-ENGLISH – 11
4.2. STERILIZATION, STORAGE AND HANDLING
Resterilization: Do not resterilize and re-implant explanted ICDs.
"Use Before" Date: A "Use Before" date is printed on the outer storage
package and on the sterile package. Do not implant the device after this
date because the battery may have reduced longevity and sterility may
be affected. It should be returned to Sorin CRM.
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 the
manufacturer.
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 0 - 50 °C (32 - 122 °F).
Temperatures outside the specified range may damage the device.
Equilibration: Allow the device to reach room temperature before
programming or implanting the device because rapid temperature
changes may affect initial device function.
4.3. IMPLANTATION AND DEVICE PROGRAMMING
Use only a Sorin CRM programmer to communicate with the device.
Do not inadvertently position any magnet over the ICD; this suspends
tachyarrhythmia detection and treatment.
Replace the device when the programmer displays an ERI (defined by
a battery voltage of 2.66 ± 0.01 V or a magnet rate lower than or equal
to 80 bpm).
Program device parameters such as sensitivity threshold and VT and
VF detection intervals as specified in the device manuals.
Lead System: Do not use a lead system other than those with
demonstrated compatibility because undersensing cardiac activity and
failure to deliver necessary therapy may result.