4.6 Resterilization and Reuse
Do not resterilize the OPTIMIZER Smart IPG, Port Plug, or the Allen wrench provided
with the device. An OPTIMIZER Smart IPG that has been explanted for any reason may
not be reimplanted in another patient.
4.7 Cremation
The OPTIMIZER Smart IPG contains a sealed chemical battery and therefore must not
be incinerated. Make absolutely sure to explant the device before a deceased patient is
cremated.
5. CAUTIONS
5.1 Environmental Conditions
The following discussion on potential hazards from the environment focuses on
maintaining the utmost patient safety. Although the OPTIMIZER Smart IPG was
designed to provide the highest possible protection against such hazards, complete
immunity against these risks cannot be guaranteed.
Note: The OPTIMIZER Smart IPG should not be used in the vicinity of other electrical
equipment. If proper separation is not feasible, the OPTIMIZER Smart IPG has to be
monitored to ensure normal function.
Just like any other IPG, the OPTIMIZER Smart IPG can be affected by interference from
magnetic, electrical, and electromagnetic signals, provided these are sufficiently strong or
have characteristics resembling cardiac activity. Most interference will lead to inhibition
of CCM signal delivery. In rare cases, an interfering signal could trigger inappropriate
CCM signal delivery. In addition, interfering signals exceeding a certain threshold may
couple enough energy into the IPG to damage the IPG circuits and/or the myocardial
tissue in the vicinity of the leads. The patient manual also covers these factors, and these
risks should be disclosed in the discussion with the patient.
The susceptibility of a particular device is dependent on the location of the IPG pocket,
the type of interfering signal, and on the programmed operating parameters.
Because of the diversity of the potential causes of electromagnetic interference, Impulse
Dynamics cannot characterize and describe all sources of interference and their effects in
this manual.
Warning: Patients should be instructed to be cautious in the vicinity of equipment that
generates electrical or electromagnetic fields and to seek medical advice
before entering an area with posted warnings advising pacemaker patients (or
patients with other types of implantable devices) not to approach.
5.2 Electrocautery
Use of surgical electrocautery devices can induce CCM signal inhibition or can 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 device can be damaged if
high energies are coupled into the system.
Use of electrocautery in close proximity to an implanted OPTIMIZER Smart IPG can
also couple radio frequency energy directly through the leads and lead tips into the
cardiac muscle tissue, producing burns or possibly cardiac arrhythmias. If electrocautery
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