St. Jude Medical GII Proclaim Manual De Instrucciones página 8

Theft detectors and metal screening devices. Certain types of antitheft devices, such as those used
at entrances or exits of department stores, libraries, and other public establishments, and airport
security screening devices may affect stimulation. Patients who are implanted with nonadjacent
multiple leads and patients who are sensitive to low stimulation thresholds may experience a
momentary increase in their perceived stimulation, which has been described by some patients as
uncomfortable or jolting. Patients should use caution when approaching such a device and should
request assistance to bypass the device. If they must proceed through the device, patients should
turn off the IPG and proceed with caution, being sure to move through the detector quickly.
Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients
should avoid placing mobile phones directly over the system.
Sterilization and Storage
Single-use, sterile device. The implanted components of this neurostimulation 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 introduction into the sterile
field. 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 Implementation
Expiration date. An expiration date (or "use-before" date) is printed on the packaging. Do not use
the system if the use-before date has expired.
Care and handling of components. Use extreme care when handling system components prior to
implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, 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 contamination is suspected for any reason.
Return any suspect components to St. Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested after implantation
and before the patient leaves the surgery suite.
Device modification. 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 St. Jude Medical for
service.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic
lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be
used, do not focus the energy near the IPG.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical
damage to an implanted neurostimulation system if used directly over the implanted system.
External defibrillators. The safety of discharge of an external defibrillator on patients with implanted
neurostimulation systems has not been established.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted
neurostimulation system, although no testing has been done and no definite 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.
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