User's Manual

US-ENGLISH – 11
4.3. IMPLANTATION AND DEVICE PROGRAMMING
Use only a Sorin CRM programmer to communicate with the device.
Do not 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.
In situations where an ICD and a pacemaker are implanted in the
same patient, interaction testing should be completed. If the
interaction between the ICD and the pacemaker cannot be resolved
through repositioning of the leads or reprogramming of either the
pacemaker or the ICD, the pacemaker should not be implanted (or
should be explanted if previously implanted).
Failure to properly insert the torque wrench into the perforation at an
angle perpendicular to the connector receptacle may result in
damage to the sealing system and its self-sealing properties.
A safety margin of at least 10 J in the defibrillation threshold (DFT) is
recommended. Carefully confirm that true ventricular fibrillation has
been induced because the DFT for ventricular tachycardia or flutter
may be lower.
The defibrillator should be implanted with the engraved side
facing outwards in order to facilitate telemetric communication
with the programming head and to display the radiographic
identification correctly.
*: corresponds to Recommended Replacement Time (RRT) / End of
Service (EOS) as referred in the EN45502-2-2 standard.