Sterilization And Storage; Handling And Implementation - Abbott Proclaim 3660 Clinician Manual

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).
Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting
objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system.
Extension of the upper torso or neck may cause lead movement and alter the stimulation field
(especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
Patient training. Instruct patients to use their neurostimulation system only after an authorized
clinician has programmed the device and has trained the patient how to control stimulation and
safely use the system.
Programmer use. Allow only authorized use of the clinician programmer to avoid any
programming changes that may injure a patient.

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.
Handle the device with care. The clinician programmer and patient controller are sensitive
electronic devices that can be damaged by rough handling, such as dropping them on the
ground.
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 Abbott Medical for evaluation.
Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as
those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion.
If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for
irrigation, and dry them completely prior to lead connection and implantation.
System testing. To ensure correct operation, always test the system during the implant
procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery
suite.
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