Abbott Eterna 32400 - Implant Precautions; Electromagnetic Interference (EMI); Consumer Device Interference

their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any
smart device in a pocket near the generator. If a paent is concerned about a smart device interacng with
their neurosmulaon system, consider disabling magnet mode. For more informaon about seng the
magnet mode, refer to the clinician programmer manual or contact Technical Support.
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.
Paent training. Instruct paents to use their neurosmulaon system only aer an authorized clinician has
programmed the generator and has trained the paent on how to safely control smulaon and to charge
the system.
Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes
that may injure a paent.
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-before” date) is printed on the packaging. Do not use the
system if the use-before date has expired.
Recharge-by date. A recharge-by date is printed on the packaging. If this date has been reached or has been
exceeded before the date of implantaon, the generator should be charged prior to implantaon.
Handle devices with care. The clinician programmer and paent controller are sensive 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
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, the device, or any device
components show signs of damage, tampering, or if the sterile seal is ruptured, or contaminaon is
suspected for any reason. Return any suspect components to Abbo Medical for evaluaon.
Exposure to body uids or saline. Exposure of the metal contacts, such as those on the connecon end of a
lead or extension, to body uids or saline prior to connecon 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, always test the system during the implant procedure, before
closing the neurosmulator pocket, and before the paent leaves the surgery suite.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic
lithotriptor, may damage the electronic circuitry of an implanted generator. If lithotripsy must be used, do
not focus the energy near the generator.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage
to an implanted neurosmulaon system if used directly over the implanted system.
External debrillators. Safety for use of external debrillator discharges on a paent receiving
neurosmulaon has not been established. External debrillaon can cause induced currents in the lead-
extension poron of the neurosmulaon system. Aer debrillaon, conrm the neurosmulaon system
is sll working.
Therapeuc radiaon. Therapeuc radiaon may damage the electronic circuitry of an implanted
neurosmulaon system, although no tesng has been done and no denite informaon on radiaon
eects is available. Sources of therapeuc radiaon include therapeuc X rays, cobalt machines, and linear
accelerators. If radiaon therapy is required, the area over the implanted generator should be shielded with
lead. Damage to the system may not be immediately detectable.
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