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. 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 and induce voltage through the lead that could jolt or shock the patient. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. IPGs contain batteries as well as other potentially hazardous materials. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. six to eight weeks after implantation of a neurostimulation system. Electrocardiograms. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Securing the IPG. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. *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. Care and handling of components. Patients should cautiously approach such devices and should request help to bypass them. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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). While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Storage environment. 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. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Wireless use restrictions. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Electrical medical treatment. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). The force of the instruments may damage the lead or stylet. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). Skydiving, skiing, or hiking in the mountains. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers All components listed must be implanted unless noted as "optional." Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. 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. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Wireless use restrictions. Case damage. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. maximize the distance between the implanted systems; Use in patients with diabetes. 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. Excessive lead migration may require reoperation to replace the leads. Bending the sheath. If interference occurs, try holding the phone to the other ear or turning off the phone. Unwanted changes in stimulation may include a jolting or shocking feeling. separates the implanted IPGs to minimize unintended interaction with other system components. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Security, antitheft, and radiofrequency identification (RFID) devices. Risk of depression, suicidal ideations, and suicide. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. 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. Only apply software updates that are published directly by Abbott Medical. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Application modification. INDICATIONS FOR USE If lithotripsy must be used, do not focus the energy near the IPG. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Electromagnetic interference (EMI). The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. If the stylet is removed from the lead, it may be difficult to reinsert it. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Follow proper infection control procedures. 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. Package or component damage. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Damage to the system may not be immediately detectable. IPG disposal. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Do not use the application if the operating system is compromised (that is, jailbroken). 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. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Long-term safety and effectiveness. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Always be aware of the needle tip position. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. 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 and induce voltage through the lead that could jolt or shock the patient. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. 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. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. If unpleasant sensations occur, the IPG should be turned off immediately. Component disposal. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol).
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