User's Manual

information on radiation effects is available. Sources of therapeutic radiation include therapeutic X
rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the
implanted IPG should be shielded with lead. Damage to the system may not be immediately
detectable.
Restricted areas.
Warn patients to seek medical guidance before entering environments that
could adversely affect the operation of the implanted device, including areas protected by a
warning notice preventing entry by patients fitted with a pacemaker.
Component manipulation by patients.
The patient must be instructed to not rub or exert
pressure on implanted components through the skin as this may cause lead dislodgement leading
to stimulation at the implant site, IPG inversion leading to the inability to communicate with the
device, or skin erosion that can lead to another surgical procedure or possible infection.
Lead movement.
Patients should be instructed to avoid bending, twisting, and stretching;
entering hyperbaric chambers above 1.5 atmospheres; operating the neurostimulator while
driving; or lifting objects over 2 kg (5 lb) for at least six weeks after implantation. These activities
may cause lead movement, resulting in understimulation or overstimulation for the patient.
Excessive lead migration may require reoperation to replace the leads.
Operation of machines, equipment, and vehicles.
In the clinical experience with this device,
patients have experienced few effects when moving from lying down to sitting up. Therefore, it is
unlikely patients will need to adjust stimulation when changing positions or moving. However,
advise patients who feel uncomfortable paresthesia during postural changes that they should not
operate potentially dangerous equipment such as power tools, automobiles, or other motor
vehicles. These patients should not climb ladders or participate in activities where postural
changes or abrupt movements could alter the perception of stimulation intensity and cause
patients to fall or lose control of equipment or vehicles or injure others.
Explosive and flammable gases.
Do not use a clinician programmer or patient controller in an
environment where explosive or flammable gas fumes or vapors are present. The operation of
these devices could cause them to ignite, causing severe burns, injury, or death.
Device components.
The use of components not approved for use by St. Jude Medical with this
system may result in damage to the system and increased risk to the patient.
Application modificiation.
To prevent unintended stimulation, do not modify the operating
system in any way. Do not use the application if the operating system is compromised (i.e.,
jailbroken).
Case damage.
Do not handle the IPG if the case is pierced or ruptured because severe burns
could result from exposure to battery chemicals.
IPG disposal.
Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain
batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG
because explosion or fire may result.
Product materials.
Neurostimulation systems have materials that come in contact or may come
in contact with tissue. A physician should determine whether or not a patient may have an allergic
reaction to these materials before the system is implanted.
Precautions
The following precautions apply to this neurostimulation system.
General Precautions
Clinician training.
Implanting physicians should be experienced in the diagnosis and treatment
of chronic pain syndromes and have undergone surgical and device implantation training.
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