Abbott Eterna 32400, Руководство для клиницистов

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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 patient is concerned about a smart device interacting with
their neurostimulation system, consider disabling magnet mode. For more information about setting the
magnet mode, refer to the clinician programmer manual or contact Technical Support.
Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects
over 2 kg (5 lb) for 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 generator and has trained the patient on how to safely control stimulation and to charge
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.
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 implantation, the generator should be charged prior to implantation.
Handle devices 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, the device, or any device
components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is
suspected for any reason. Return any suspect components to Abbott Medical for evaluation.
Exposure to body fluids or saline. Exposure of the metal contacts, such as those on the connection end of a
lead or extension, to body fluids or saline prior to connection 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.
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 neurostimulation system if used directly over the implanted system.
External defibrillators. Safety for use of external defibrillator discharges on a patient receiving
neurostimulation has not been established. External defibrillation can cause induced currents in the lead-
extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system
is still working.
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 generator should be shielded with
lead. Damage to the system may not be immediately detectable.
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