Abbott Eterna 32400, Clinician Manual

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Keep dry to avoid damage. Clinician programmers, patient controllers, and chargers are not waterproof.
Keep them dry to avoid damage. Advise patients to not use their devices when engaging in activities that
might cause them 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. This 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 generator software in any
way. Only apply software updates that are published directly by Abbott Medical.
Case damage. Do not handle the generator if the case is pierced or ruptured because severe burns could
result from exposure to battery chemicals.
Generator disposal. Return all explanted generators to Abbott Medical for safe disposal. generators contain
batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the generator
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. Patients should avoid charging their generator over
an incision that has not completely healed. 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 generators 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.
Implant heating. While charging the generator, patients may perceive an increase in temperature at the
generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant
where the patient has normal sensation.
High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor
disturbances or render the patient incapable of controlling the generator. If unpleasant sensations occur,
turn off stimulation immediately.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can
generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage
system components. Patients should avoid getting too close to these types of EMI sources, which include
the following examples: commercial electrical equipment (such as arc welders and induction furnaces),
communication equipment (such as microwave transmitters and high-power amateur transmitters), high-
voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as
therapeutic radiation and electromagnetic lithotripsy).
Consumer goods and electronic devices. Magnetic interference with consumer goods or electronic devices
that contain magnets, such as mobile phones and smart watches, may unintentionally cause the
neurostimulation system to turn on or turn off or affect communication between the device and generator;
however, it will not change the prescribed programmed parameters. Patients should be advised to keep
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