Use Instructions

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5.3 RF Ablation
Warning: RF ablation can cause the OPTIMIZER Smart Mini IPG to inhibit CCM therapy delivery
or to revert to its “DOWN” mode (equivalent to 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 radiofrequency (RF)
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 Mini IPG and the leads is minimized.
Avoid direct contact between the ablation catheter and the OPTIMIZER Smart Mini IPG or its
leads. The risk of adverse effects can be decreased by reprogramming the OPTIMIZER Smart
Mini IPG into OOO mode. The patient’s peripheral pulse should be monitored throughout the
procedure and correct operation of the OPTIMIZER Smart Mini IPG should be verified
immediately after the procedure. If the device has gone into its “DOWN” mode, it will need to be
reset by qualified personnel. A consequence of a device reset is that all statistical data stored in
the IPG is cleared.
5.4 Diathermy (Medical “Short Wave” Induction Heating)
Warning: Medical diathermy is generally contraindicated in patients with implanted devices. The
effects of such intense energies on the OPTIMIZER Smart Mini 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 should not be applied in close
proximity of the OPTIMIZER Smart Mini IPG and its associated leads. The risk of adverse effects
can be decreased by reprogramming the OPTIMIZER Smart Mini IPG into OOO mode. The
patient’s peripheral pulse should be monitored throughout the procedure and correct operation of
the OPTIMIZER Smart Mini IPG should be verified immediately after the procedure. If the device
has gone into its “DOWN” mode, it will need to be reset by qualified personnel. A consequence of
a device reset is that all statistical data stored in the IPG is cleared.
5.5 Defibrillation and Cardioversion
Warning: 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 Mini
IPG revert to its “DOWN” mode (equivalent to OOO mode, with no delivery of CCM).
The OPTIMIZER Smart Mini IPG and its leads can be damaged by exposure to high
energies.
No particular paddle placement can avoid such damage. To decrease the risk, it is recommended
to position the paddles anterior and posterior, as far away from the OPTIMIZER Smart Mini IPG
as possible. In addition, paddle positions that would bring the OPTIMIZER Smart Mini IPG into
the direct path of the defibrillation current should be avoided.
After defibrillation, the function of the OPTIMIZER Smart Mini IPG should be closely monitored. In
the unlikely event of abnormal function, lead repositioning (or replacement), reprogramming of the
IPG may be required. If the device is found to have reverted to its “DOWN” mode, it will need to
be reset by qualified personnel. A consequence of a device reset is that all statistical data stored
in the IPG is cleared.
Internal defibrillation will not damage the device.