Monitoring devices that use needle electrodes are not recommended. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Memo on file. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. MRI systems that meet the following criteria: • MRI magnet strength of 1.5T only, in a horizontal closed bore system (no … Intended Use. patients with chronic pain caused by CRPS or causalgia the chance to try a temporary evaluation of our DRG system before they commit to an implant. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. An expiration date (or “use-before” date) is printed on the packaging. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Inspection. 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. Do not suture directly onto the lead to avoid damaging the lead. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Ensure the patient does not come into contact with metal parts of the table and its accessories. Patients should cautiously approach such devices and should request help to bypass them. Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Patient selection. In fact, approximately 82% of patients with an implanted spinal cord stimulation system (SCS) are expected to need at least one MRI within five years of implant. Do not move the electrode while it is activated. Failure to do so may result in damage to the sheath. Package or component damage. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. 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. MRI COMPATIBILITY In the future, you may need magnetic resonance imaging (MRI) to diagnose an illness. Stop if heat is felt at site of the grounding pad. Do not operate the equipment again until the source of the problem is identified and corrected. View and Download Abbott St. Jude Medical Patient Controller 3875 user manual online. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Follow proper infection control procedures. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Excessive lead migration may require reoperation to replace the leads. Antistatic sheeting is recommended. Explosive and flammable gases. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. IPG disposal. Keep the device dry. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. Explosion hazard. St. Jude Medical Product Manuals Access online digital product and treatment information for patients or healthcares professionals to view, download or print. 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. If unpleasant sensations occur, the device should be turned off immediately. Abbott’s new Proclaim XR SCS system offers a safe and effective, non-opioid option for managing chronic pain. Therapeutic radiation. Failure to do so may cause harm to the patient such as damage to the dura. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Electrocardiograms. Check whether the patient has an electrically conductive implant and, if so, obtain qualified advice before using the generator. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. One extensive study in the medical literature found 38% of the research participants had device-related problems.9 The most common complications were unintended movement (also called migration) of the leads, failed co… INDICATIONS Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. If the patient complains of heating at the grounding pad site, stop the procedure and remove the grounding pad from the patient. Patient Controller App, 3875 Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Activities requiring excessive twisting or stretching. The Prodigy MRI™ SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott’s smallest implantable pulse generator (IPG). Lead insertion through sheath. 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 at manuals.sjm.com). While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Patient's visual ability to read the patient controller screen. The system is intended to be used with leads and associated extensions that are compatible with the system. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Use dry gauze if necessary. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. This damage could result in loss of therapy, requiring additional surgery for system replacement. Use caution when sedating the patient. For safety, always have someone positioned next to the Emergency Stop button during operation. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. St. Jude Medical Patient Controller 3875 medical equipment pdf manual download. Skydiving, skiing, or hiking in the mountains. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. © 2018 Abbott. When cleaning the outer casing or touchscreen, do not use abrasive agents or solvents. If interference occurs, try holding the phone to the other ear or turning off the phone. Restricted areas. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than forty internationally respected experts in the field. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Diathermy is further prohibited because it may also damage the neurostimulation system components. Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. The tip of the sheath may whip around and could cause harm to the patient. See "Appendix B: System Components and Accessories" (page 1). For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. If unexpected parameter readings are observed that do not correspond to the preset values, halt the procedure immediately by pressing the Emergency Stop button. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. See "Cleaning the Generator" (page 32). Providing strain relief. Magnetic resonance imaging (MRI). No modification of this equipment is allowed. High stimulation outputs. After defibrillation, confirm the neurostimulation system is still working. Safety and effectiveness of neurostimulation for pediatric use have not been established. Built with Abbott’s revolutionary BurstDR™ Stimulation, the A prospective in vivo study in patients with SCS, exploring the changes produced by 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. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The safety and effectiveness of neurostimulation for pediatric use have not been established. But when you have an implanted device, you have to be careful about MRI scans. In general, any sign that gives warnings for people with heart pacemakers also applies to spinal cord stimulators. Check whether the patient has a cardiac pacemaker or other active implantable device and, if so, obtain qualified advice before using the generator. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Storage environment. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. If unpleasant sensations occur, the IPG should be turned off immediately. External defibrillators. View product information for Medtronic neurostimulators used for spinal cord stimulation, for the management of chronic pain. Component manipulation by patients. Only approved medical grade power cords can be used with the generator. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Now offering unique, low-energy form options for spinal cord stimulation. With innovative devices like the Proclaim DRG Neurostimulation System , living with pain doesn't have to sidetrack your life. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Pregnancy and nursing. Damage to the system may not be immediately detectable. Use only the power cord specified for this unit. 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. MRI systems that meet the following criteria: • MRI magnet strength of 1.5T only Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. The implanted components of this neurostimulation system are intended for a single use only. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. “I told them that it feels like the lead is moving up and down my spine,” one patient said. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Electric shock hazard. Every day, chronic pain slows down about 1.5 billion people worldwide.1 At Abbott, we’re ready to partner with you to deliver relief, one patient at a time. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Patients who are unable to properly operate the system. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable.
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