Abbott Eterna 32400 - Device Handling and Modification; General Precautions

Keep dry to avoid damage. Clinician programmers, paent controllers, and chargers are not waterproof.
Keep them dry to avoid damage. Advise paents to not use their devices when engaging in acvies that
might cause them to get wet, such as swimming or bathing.
Pediatric use. Safety and eecveness of neurosmulaon for pediatric use have not been established.
Pregnancy and nursing. Safety and eecveness of neurosmulaon for use during pregnancy and nursing
have not been established.
Device components. The use of components not approved for use by Abbo Medical with this system may
result in damage to the system and increased risk to the paent.
Device modicaon. 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 Abbo Medical for service.
Applicaon modicaon. To prevent unintended smulaon, do not modify the generator soware in any
way. Only apply soware updates that are published directly by Abbo Medical.
Case damage. Do not handle the generator if the case is pierced or ruptured because severe burns could
result from exposure to baery chemicals.
Generator disposal. Return all explanted generators to Abbo Medical for safe disposal. generators contain
baeries as well as other potenally hazardous materials. Do not crush, puncture, or burn the generator
because explosion or re may result.
Product materials. Neurosmulaon systems have materials that come in contact or may come in contact
with ssue. A physician should determine whether or not a paent may have an allergic reacon to these
materials before the system is implanted.
Precauons
The following precauons apply to this neurosmulaon system.
General Precauons
Clinician training. Implanng physicians should be experienced in the diagnosis and treatment of chronic
pain syndromes and have undergone surgical and device implantaon training.
Paent selecon. It is extremely important to select paents appropriately for neurosmulaon. Thorough
psychiatric screening should be performed. Paents should not be dependent on drugs and should be able
to operate the neurosmulaon system.
Infecon. Follow proper infecon control procedures. Paents should avoid charging their generator over
an incision that has not completely healed. Infecons related to system implantaon might require that the
device be explanted.
Implantaon of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the
implanted generators to minimize unintended interacon with other system components.
Implantaon of mulple leads. If mulple leads are implanted, leads and extensions should be routed in
close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnec energy that could
cause the paent unwanted smulaon.
Implant heang. While charging the generator, paents may perceive an increase in temperature at the
generator site. In paents who have areas of increased sensivity to heat, consider placing the implant
where the paent has normal sensaon.
High smulaon outputs. Smulaon at high outputs may cause unpleasant sensaons or motor
disturbances or render the paent incapable of controlling the generator. If unpleasant sensaons occur,
turn o smulaon immediately.
Electromagnec interference (EMI). Some equipment in home, work, medical, and public environments can
generate EMI that is strong enough to interfere with the operaon of a neurosmulaon system or damage
system components. Paents should avoid geng too close to these types of EMI sources, which include
the following examples: commercial electrical equipment (such as arc welders and inducon furnaces),
communicaon equipment (such as microwave transmiers and high-power amateur transmiers), high-
voltage power lines, radiofrequency idencaon (RFID) devices, and some medical procedures (such as
therapeuc radiaon and electromagnec lithotripsy).
Consumer goods and electronic devices. Magnec interference with consumer goods or electronic devices
that contain magnets, such as mobile phones and smart watches, may unintenonally cause the
neurosmulaon system to turn on or turn o or aect communicaon between the device and generator;
however, it will not change the prescribed programmed parameters. Paents should be advised to keep
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