is used, only brief signal bursts may be delivered and the neutral electrode has to be
positioned such that the current affecting the OPTIMIZER Smart IPG and the attached
leads is minimized. The risk of adverse effects can be decreased by reprogramming the
OPTIMIZER Smart IPG into Standby (OOO) mode. The patient’s peripheral pulse
should be monitored throughout the procedure and correct operation of the OPTIMIZER
Smart IPG should be verified immediately after the procedure. If the device has gone into
its “DOWN” mode, it needs to be reset (how to proceed with an OPTIMIZER Smart IPG
reset is detailed in Section 21).
5.3 RF Ablation
RF ablation can cause the OPTIMIZER Smart IPG to inhibit CCM signal delivery or to
revert to its “DOWN” mode [Standby (OOO) mode, with no delivery of CCM] with the
possible loss of statistical data. Depending on the amount of energy coupled into the
system, the device could also be damaged. If an RF ablation procedure is performed in
close proximity to the leads, the leads can couple radio frequency energy via the lead tips
into the myocardium, producing burns or possibly cardiac arrhythmias.
If an RF ablation procedure has to be performed, the neutral electrode should be
positioned such that the current flowing through the OPTIMIZER Smart IPG and the
leads is minimized. Avoid direct contact between the ablation catheter and the
OPTIMIZER Smart IPG or its leads. The risk of adverse effects can be decreased by
reprogramming the OPTIMIZER Smart IPG into Standby (OOO) mode. The patient’s
peripheral pulse should be monitored throughout the procedure and correct operation of
the OPTIMIZER Smart IPG should be verified immediately after the procedure. If the
device has gone into its “DOWN” mode, it needs to be reset (how to proceed with an
OPTIMIZER Smart IPG reset is detailed in Section 21).
5.4 Diathermy (Medical “Short Wave” Induction Heating)
Medical diathermy is generally contraindicated in patients with implanted devices. The
effects of such intense energies on the OPTIMIZER Smart IPG cannot be predicted.
Although damage to the circuitry of the IPG and/or the myocardium appears unlikely, it
nevertheless could occur.
If diathermy is to be used notwithstanding the contraindication, it may not be applied in
proximity of the OPTIMIZER Smart IPG and its leads. The risk of adverse effects can be
decreased by reprogramming the OPTIMIZER Smart IPG into Standby (OOO) mode.
The patient’s peripheral pulse should be monitored throughout the procedure and correct
operation of the OPTIMIZER Smart IPG should be verified immediately after the
procedure. If the device has gone into its “DOWN” mode, it needs to be reset (how to
proceed with an OPTIMIZER Smart IPG reset is detailed in Section 21).
5.5 Defibrillation and Cardioversion
Any implanted device can be damaged by external cardioversion or defibrillation. In
addition, the myocardium adjacent to the lead tips and/or the tissue in the area of the
device may be damaged. Altered signal thresholds could also be one of the consequences.
The defibrillation current can also make the OPTIMIZER Smart IPG revert to its
“DOWN” mode [Standby (OOO) mode, with no delivery of CCM] with the possible loss
of statistical data. The system can be damaged by exposure of high energies.
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