Use Instructions

10
5.10 Handling
Warning: Do not implant the OPTIMIZER Smart Mini IPG if the package is damaged or if the
device has been dropped onto a hard surface from a height of 12 in or more while still
in the shipping box. Do not implant the device if it has been dropped onto a hard
surface after unpacking. Damaged packages or dropped devices should be returned to
Impulse Dynamics for evaluation.
5.11 Resterilization and Reuse
Warning: An OPTIMIZER Smart Mini IPG or Port Plug that has been explanted for any reason
must not be reused in another patient.
Do not resterilize and/or reuse the OPTIMIZER Smart Mini IPG, the Port Plug, or the torque
wrench provided with the device.
5.12 Cremation
Warning: Never incinerate an OPTIMIZER Smart Mini IPG. The IPG must be explanted before
the deceased patient is cremated.
The OPTIMIZER Smart Mini IPG contains a sealed chemical battery. Make absolutely certain that
an implanted OPTIMIZER Smart Mini IPG is removed before a deceased patient is cremated.
6.0 CAUTIONS
6.1 Environmental Conditions
The following discussion on potential hazards from the environment focuses on maintaining the
utmost patient safety. Although the OPTIMIZER Smart Mini IPG was designed to provide the
highest possible protection against such hazards, complete immunity against these risks cannot
be guaranteed.
The OPTIMIZER Smart Mini IPG should not be used in the vicinity of other electrical equipment
capable of producing signals that could interfere with its operation. If proper separation is not
feasible, the OPTIMIZER Smart Mini IPG has to be monitored to ensure normal function.
Similar to other cardiac rhythm management IPGs, the OPTIMIZER Smart Mini 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 therapy delivery. In rare cases, an interfering signal could trigger
inappropriate CCM therapy 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’s Manual addresses these risks, which should be
discussed during consultations with the patient.
The susceptibility of a particular device is dependent on the location of the IPG pocket, the type of
interfering signal, and 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 its effects in this
manual.
Caution: Patients should be instructed to be cautious in the vicinity of equipment that generates
strong 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.
6.2 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 Mini IPG.