Abbott Prodigy 3855 - Page 7

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 recharging an IPG, paents may perceive an increase in temperature. 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 may render the paent incapable of controlling the paent programmer. If unpleasant
sensaons occur, the device should be turned o immediately.
Postural changes. Changes in posture or abrupt movements may result in a decrease or increase in the
perceived level of smulaon. Percepon of higher levels of smulaon has been described by some paents
as uncomfortable, painful, or jolng. Paents should be advised to turn down the amplitude or turn o the
IPG before making extreme posture changes or abrupt movements such as stretching, liing their arms over
their heads, or exercising. If unpleasant sensaons occur, the IPG should be turned o immediately.
The detectors and metal screening devices. Certain types of anthe devices, such as those used at
entrances or exits of department stores, libraries, and other public establishments, and airport security
screening devices may aect smulaon. Paents who are implanted with nonadjacent mulple leads and
paents who are sensive to low smulaon thresholds may experience a momentary increase in their
perceived smulaon, which has been described by some paents as uncomfortable or jolng. Paents
should use cauon when approaching such a device and should request assistance to bypass the device. If
they must proceed through the device, paents should turn o the IPG and proceed with cauon, being sure
to move through the detector quickly.
Lead movement. Paents should be instructed to avoid bending, twisng, stretching, and liing objects over
2 kg (5 lb) for six to eight weeks aer implantaon of a neurosmulaon system. Extension of the upper torso
or neck may cause lead movement and alter the smulaon eld (especially with leads in the cervical area),
resulng in oversmulaon or ineecve smulaon.
Smulaon parameters. Paents should be cauoned that smulaon parameters must be determined
under the supervision of a physician and that they should not adjust smulaon parameters within prescribed
programs unless ordered to do so by a physician.
Mobile phones. The eect of mobile phones on neurosmulaon systems is unknown; paents should avoid
placing mobile phones directly over the system.
Sterilizaon and Storage
Single-use, sterile device. The implanted components of this neurosmulaon system are intended for a
single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before
shipment and are supplied in sterile packaging to permit direct introducon into the sterile eld. Do not
resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact with liquids
of any kind.
Handling and Implementaon
Expiraon date. An expiraon date (or “use‑by” date) is printed on the packaging. Do not use the system if
the use‑by date has expired.
Care and handling of components. Use extreme care when handling system components prior to
implantaon. Excessive heat, excessive tracon, excessive bending, excessive twisng , or the use of sharp
instruments may damage and cause failure of the components.
Package or component damage. Do not implant a device if the sterile package or components show signs of
damage, if the sterile seal is ruptured, or if contaminaon is suspected for any reason. Return any suspect
components to Abbo Medical
for evaluaon.
Exposure to body uids or saline. Prior to connecon, exposure of the metal contacts, such as those on the
connecon end of a lead or extension, to body uids or saline can lead to corrosion. If such exposure occurs,
clean the aected parts with sterile, deionized water or sterile water for irrigaon, and dry them completely
prior to lead connecon and implantaon.
System tesng. To ensure correct operaon, the system should always be tested aer implantaon and
before the paent leaves the surgery suite.
Device modicaon. The 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.
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