abbott proclaim spinal cord stimulator mri safety abbott proclaim spinal cord stimulator mri safety

Do not use the application if the operating system is compromised (i.e., jailbroken). Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. January 4, 2022 By Sean Whooley. Keep dry to avoid damage. 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. Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. Set the electrosurgery device to the lowest possible energy setting. The IPG should be explanted before cremation because the IPG could explode. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Battery precaution. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. radiofrequency identification (RFID) devices. Needle positioning. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Skydiving, skiing, or hiking in the mountains. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. 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. Activities requiring coordination. Skin erosion. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Removing components. Using the tunneling tool. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. 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. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Electrosurgery. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. 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. Explosive and flammable gasses. Diathermy therapy. Return the explanted IPG to Abbott Medical. If lithotripsy must be used, do not focus the energy near the IPG. 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. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Patients should avoid charging their generator over an incision that has not completely healed. Emergency procedures. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Magnetic resonance imaging (MRI). If interference occurs, try holding the phone to the other ear or turning off the phone. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. To prevent injury or damage to the system, do not modify the equipment. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Caution patients to not make unauthorized changes to physician-established stimulation parameters. 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). Security, antitheft, and radiofrequency identification (RFID) devices. 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. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Inaccurate ECG results may lead to inappropriate treatment of the patient. High stimulation outputs. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. 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. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Advance the needle and guidewire slowly. maximize the distance between the implanted systems; Use in patients with diabetes. If multiple leads are implanted, leads and extensions should be routed in close proximity. 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. 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). 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. Magnetic resonance imaging (MRI). To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Patients should cautiously approach such devices and should request help to bypass them. Risk of depression, suicidal ideations, and suicide. If needed, return the equipment to Abbott Medical for service. 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. Exposure to body fluids or saline. Stimulation Modes. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. 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). Patient activities and environmental precautions. Single-use, sterile device. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Damage to the system may not be immediately detectable. Unauthorized changes to stimulation parameters. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The placement of the leads involves some risk, as with any surgical procedure. High stimulation outputs. Transcutaneous electrical nerve stimulation (TENS). 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. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Avoid excessive stimulation. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. If unpleasant sensations occur, the IPG should be turned off immediately. Security, antitheft, and radiofrequency identification (RFID) devices. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Diathermy is further prohibited because it may also damage the neurostimulation system components. Implanting physicians should be experienced in stereotactic and functional neurosurgery.