Physicians need to be aware of the following warnings:ĭo not use extension cords or adapters of any type. This device presents a fire hazard under certain conditions. Do not use this equipment in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.įire hazard. Do not operate the equipment again until the source of the problem is identified and corrected.Įxplosion hazard. If unexpected parameters are observed that do not correspond to the preset values, halt the procedure immediately by pressing the Emergency Stop button on the top of the generator. A failure of the equipment could result in an unintended increase of output power. Turn off the equipment and unplug the power cord before cleaning or servicing.ĭo not allow any fluid to enter the ventilation holes or sockets.Įquipment failure. Replace the power cord or plug immediately if it is cracked, frayed, broken, or otherwise damaged. For service, contact Abbott Medical.ĭo not under any circumstances perform testing or maintenance on the equipment while it is being used on a patient. No modification of this equipment is allowed.ĭo not attempt to service or modify the equipment. Use only the power cord specified for this unit. Only approved medical grade power cords can be used with the generator. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Physicians need to be aware of the following warnings: This device presents an electric shock hazard under certain conditions. The generator is for use only by qualified medical personnel.Įlectric shock hazard. Read and understand the instructions for use provided in this clinician's manual before operating the generator. The following warnings apply to this generator. The use of this device is contraindicated in patients with systemic infection or local infection in the area of the procedure. Examples include facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures. The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is intended for lesioning of neural tissue in the nervous system as an aid in the management of pain. Read this section to gather important prescription and safety information. IonicRF™ Generator Prescription And Safety Information IonicRF™ Generator User Needs Validation Report (90624319). IonicRF™ Generator Summative Validation Report (90624300). IonicRF Accessory Compatibility Validation Report (90627604).
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