5.8 Lithotripsy
Warning: Direct exposure of the OPTIMIZER Smart IPG to shock waves can damage
the device. A device implanted outside the shock wave path presents no clear-
cut contraindication to lithotripsy. Precautionary programming of the
OPTIMIZER Smart IPG to Standby (OOO) mode reduces the risk of adverse
effects. The patient’s peripheral pulse should be monitored during the
procedure. Immediately after the treatment, the OPTIMIZER Smart IPG has
to be checked for proper function. If the device is found to have reverted to its
“DOWN” mode, it needs to be reset (how to proceed with an OPTIMIZER
Smart IPG reset is detailed in Section 21).
5.9 Therapeutic Ultrasound
Warning: Direct exposure of the OPTIMIZER Smart IPG to therapeutic ultrasound can
damage the device. In addition, unexpected focusing of the ultrasound beam
may harm the patient.
Therapeutic ultrasound can be used provided the implant is located far away from the
ultrasound field and clearly outside the field. Precautionary programming the
OPTIMIZER Smart IPG to Standby (OOO) mode reduces the risk of adverse effects. The
patient’s peripheral pulse should be monitored during the procedure. Immediately after
the treatment, the OPTIMIZER Smart IPG should be checked for proper function. If the
device is found to have reverted to its “DOWN” mode, it needs to be reset (how to
proceed with an OPTIMIZER Smart IPG reset is detailed in Section 21).
5.10 Transcutaneous Electrical Nerve Stimulation (TENS)
TENS is generally contraindicated in patients with implanted electrical devices. The
high-voltage impulse delivered into the body by the TENS unit can impair the operation
of the OPTIMIZER Smart IPG.
If a TENS unit is used nonetheless, the TENS electrodes have to be attached as far as
possible from the OPTIMIZER Smart IPG and its leads. In addition, aiming for a limited
current path, the TENS electrodes should be placed as close to each other as possible.
The patient’s peripheral pulse should be closely monitored while TENS is applied.
Precautionary programming the OPTIMIZER Smart IPG to Standby (OOO) mode
reduces the risk of adverse effects.
5.11 Home Appliances
Home and commercial microwave ovens do not affect the operation of the OPTIMIZER
Smart IPG, provided they are in good condition and used as intended. Even microwave
energy from a severely defective microwave oven directly radiating onto the IPG does
not damage the device, although the sensing function may be impaired, which could
eventually impact CCM signal delivery.
Patients with an implanted OPTIMIZER Smart IPG should be advised that some electric
razors, electric power tools, and electric ignition systems, including those of gasoline
powered engines, could cause interference. Generally, patients implanted with an
OPTIMIZER Smart IPG may use gasoline powered engines, provided that protective
hoods, shrouds, and other shielding devices have not been removed.
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