Abbott Eterna 32400 - Electrosurgery Precautions; Device Interference and Safety

Diathermy is further prohibited because it may also damage the neurosmulaon system components. This
damage could result in loss of therapy, requiring addional surgery for system implantaon and
replacement. Injury or damage can occur during diathermy treatment whether the neurosmulaon system
is turned on or o.
Electrosurgery. To avoid harming the paent or damaging the neurosmulaon system, do not use
monopolar electrosurgery devices on paents with implanted neurosmulaon systems. If use of
electrocautery is necessary, place the neurosmulator in Surgery mode using the clinician programmer app
or the paent controller app before using an electrosurgery device.
During the implant procedure, if an electrosurgery device must be used, take the following acons:
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Use bipolar electrosurgery only.▪
▪ Place the neurosmulator in Surgery mode before using an electrosurgery device.
▪
▪
Set the electrosurgery device to the lowest possible energy seng. Output power below 80 W is▪
recommended for all acvaons.
▪
Complete any electrosurgery before connecng the leads or extensions to the neurosmulator.▪
▪
Keep the current paths from the electrosurgery device as far from the neurosmulaon system as
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possible.
▪
Exit Surgery mode during intraoperave tesng and aer the procedure is completed.
▪
NOTE: During intraoperave tesng, Surgery mode must be turned o for the neurosmulaon system
to funcon correctly.
▪
Conrm that the neurosmulaon system is funconing correctly during the implant procedure, before
▪
closing the neurosmulator pocket, and aer the implant procedure.
Aer any surgery, check the neurosmulaon system for the following:
▪
Check the neurosmulator to ensure Surgery mode has been turned o, even if Surgery mode was not
▪
turned on at the beginning or during the procedure.
▪
Conrm the neurosmulaon system is funconing.
▪
Implanted cardiac systems. Physicians need to be aware of the risk and possible interacon between a
neurosmulaon system and an implanted cardiac system, such as a pacemaker or debrillator. Electrical
pulses from a neurosmulaon system may interact with the sensing operaon of an implanted cardiac
system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac
system from sensing the output of the neurosmulaon system, (1) maximize the distance between the
implanted systems; (2) verify that the neurosmulaon system is not interfering with the funcons of the
implanted cardiac system; (3) avoid programming either device in a unipolar mode (using the device’s can as
an anode) or using neurosmulaon system sengs that interfere with the funcon of the implantable
cardiac system.
Other acve implanted devices. The neurosmulaon system may interfere with the normal operaon of
another acve implanted device, such as a pacemaker, debrillator, or another type of neurosmulator.
Conversely, the other acve implanted device may interfere with the operaon of the neurosmulaon
system.
Interference with other devices. Some of this system’s electronic equipment, such as the programmer and
controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including
other acve implanted devices. Avoid placing equipment components directly over other electronic devices.
To correct the eect of interference with other devices, turn o the equipment or increase the distance
between the equipment and the device being aected.
Operaon of machines, equipment, and vehicles. Paents using therapy that generates paresthesia should
turn o smulaon before operang motorized vehicles, such as automobiles, or potenally dangerous
machinery and equipment because sudden smulaon changes may distract them from properly operang
it. However, current data shows that most paents using BurstDR™ smulaon therapy do not experience
paresthesia. For paents who do not feel paresthesia, sudden smulaon changes are less likely to occur
and distract them while operang motorized vehicles, machinery, or equipment.
Explosive and ammable gases. Do not use a clinician programmer or paent controller around explosive or
ammable gas fumes or vapors. This includes oxygen-enriched environments such as hyperbaric chambers.
Operang the device near gas fumes or vapors could cause them to catch re. If gas fumes or vapors catch
re, it could cause severe burns, injury, or death.
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