St.Jude Medical Proclaim Manuel page 6

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.
4
ARTMT100145789A.pdf 6 11/11/2015 8:52:57 AM