Precautions - Abbott Proclaim 3660 Clinician Manual

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.
Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to
avoid damage. Advise patients to not use their device when engaging in activities that might cause
it to get wet, such as swimming or bathing.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been
established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy
and nursing have not been established.
Device components. The use of components not approved for use by Abbott Medical with this
system may result in damage to the system and increased risk to the patient.
Device modification. Equipment is not serviceable by the customer. To prevent injury or damage
to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical
for service.
Application modification. 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 Abbott 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.
Patient selection. It is extremely important to select patients appropriately for neurostimulation.
Thorough psychiatric screening should be performed. Patients should not be dependent on drugs
and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation
might require that the device be explanted.
Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in)
separates the implanted IPGs to minimize unintended interaction with other system components.
Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be
routed in close proximity. Nonadjacent leads can possibly create a conduit for stray
electromagnetic energy that could cause the patient unwanted stimulation.
High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor
disturbances, or render the patient incapable of controlling the stimulator. If unpleasant
sensations occur, the device should be turned off immediately.
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