![]() For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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. Insertion of a sheath without the lead may result in dural puncture. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Patients should exercise reasonable caution when bathing. 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. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. commercial electrical equipment (such as arc welders and induction furnaces). Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Failure to do so may result in damage to the sheath. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Failure to provide strain relief may result in lead migration requiring a revision procedure. 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. Do not use the system if the use-before date has expired. 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). If needed, return the equipment to Abbott Medical for service. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). The equipment is not serviceable by the customer. Return them to Abbott Medical for proper disposal. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). A recharge-by date is printed on the packaging. ![]() Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. 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. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider.
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