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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Avoid placing equipmentcomponents directly over other electronic devices. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. For more information about MR Conditional products, visit the Abbott product information page atsjm.com/MRIReady. Safety and effectiveness of neurostimulation for pediatric use have not been established. Contamination of the device may lead to injury, illness, or death of the patient. Before you get an MRI scan with any implanted device, you need to make sure that your device is eligible to receive that kind of scan. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. These radiopaque markers clearly show the separation of the three electrodes under X-ray. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Do not use surgical instruments to handle the lead. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. The use of this device is contraindicated in patients with systemic infection or local infection in the area of the procedure. 2018 Abbott. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. This device is not intended for bilateral use. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Radiofrequency or microwave ablation.Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Schedule your MRI appointment. The IPG should be explanted before cremation because the IPG could explode. Its small, discreet and available with Abbotts proprietary BurstDR stimulation, a new technology thats clinically proven to provide better pain relief than traditional neurostimulation. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Fire hazard. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Neurostimulation trial systems. The text begins with a discussion of basic MRI physics and then proceeds to a description of the bioeffects of static, gradient, and radiofrequency electromagnetic fields as well as the risks associated with acoustic noise. Other active implanted devices. Its important that the MRI clinic understands and can meet the MR conditions and settings required for your implanted neurostimulator. 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. Computed tomography (CT). Return of symptoms and rebound effect.The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Only approved medical grade power cords can be used with the generator. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Component disposal. Removing each item in slow movements while holding the remaining components in place will assist this process. Inform the patient with a neurostimulation system that stimulation needs to be turned off prior to the MRI scan. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Exposure to body fluids or saline. Move through the device quickly. Keep reading to learn more about how to receive an MRI with a neurostimulator device. The implanted components of this neurostimulation system are intended for a single use only. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Safety Info ID# Safety Topic / Subject Article Text 255: Bone Fusion (Spinal) Stimulator: The implantable bone fusion or spinal fusion stimulator is designed for use as an adjunct therapy to a spinal fusion procedure. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Device components. Place a new grounding pad on a fresh patch of skin. Electrocardiograms.Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. This book is your essential companion when preparing for board review and recertification exams and in your daily clinical practice. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Avoid using physiological monitoring equipment during a procedure. Under specific conditions. Found inside Page 1But for many clinicians, these new methods pose many questions. What are the available modalities? How do they work? Which patients might benefit from them? How do I explain the processes to patients? Store components and their packaging where they will not come in contact with liquids of any kind. 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