Part of Abbott’s suite of chronic pain therapies, the IonicRF™ Generator brings high-efficiency performance1 to pain relief, targeting discrete areas that include:
- Neck2-3
- Upper2 and lower2 back
- Sacroiliac joint4
- Facial pain5
- Shoulder
- Knee
- Hip
- Foot
Part of Abbott’s suite of chronic pain therapies, the IonicRF™ Generator brings high-efficiency performance1 to pain relief, targeting discrete areas that include:
The IonicRF™ Generator provides flexible chronic pain management to treat a variety of patient populations, and covers a range of procedure types:
The system offers intelligent control of the Simplicity™ RF Denervation Probe, which has three independent electrodes to create a true strip lesion with a single insertion point. The result is greater anatomical coverage in less time.4
The IonicRF™ Generator features include:
The system is also compatible with Abbott’s comprehensive portfolio of needles—16, 18, 20, and 22 gauge—as well as single-use and reusable electrodes.6
The design of the IonicRF™ Generator enables healthcare teams to quickly become proficient in its use.8 The system features:
Reorder Number | Description |
---|---|
RFG-IONIC | IonicRF™ Generator |
Accessories
Reorder Number | Description |
---|---|
RD-0856 | IonicRF™ Generator Roll Stand |
RF-POLE | IonicRF™ Generator Pole Mount |
RF-DGP-IS | IonicRF™ Generator Grounding Pad |
Click below to see more of Abbott's neurostimulation product portfolio for chronic pain.
™ Indicates a trademark of the Abbott group of companies.
Read this section to gather important prescription and safety information.
The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is intended for lesioning of neural tissue in the peripheral nervous system as an aid in the management of pain.
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. Examples include, but are not limited to, facet denervation, rhizotomy, and related functional neurosurgical procedures.
The use of this device is contraindicated in patients with systemic infection or local infection in the area of the procedure.
The following warnings apply to this generator.
Instructions for use. Read and understand the instructions for use provided in this clinician's manual before operating the generator.
Hazardous electrical output. The generator is for use only by qualified medical personnel.
Electric shock hazard. This device presents an electric shock hazard under certain conditions. Physicians need to be aware of the following warnings:
Equipment failure. A failure of the equipment could result in an unintended increase of output power. 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. Do not operate the equipment again until the source of the problem is identified and corrected.
Explosion hazard. Do not use this equipment in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Fire hazard. This device presents a fire hazard under certain conditions. Physicians need to be aware of the following warnings:
Pooling hazard. Flammable solutions may pool under the patient or in body depressions, such as the umbilicus, and in body cavities, such as the vagina. Remove fluids pooled in body depressions and cavities before using the generator.
Ignition hazard. Be aware of and take care to avoid the danger of ignition of endogenous gasses (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the generator).
Risk of RF burns and unintended stimulation. Do not turn the generator power on while touching any electrodes or probes. Do not place a generator-connected electrode that is not being used in contact with the patient.
Risk of RF burns to patient. This device presents a risk of RF burns to the patient under certain conditions. Physicians need to be aware of the following warnings:
Interference with active implants. Check whether the patient has a cardiac pacemaker or other active implantable device and, if so, obtain qualified advice before using the generator. Operating the generator may interfere with or damage the implanted device.
Redirection of high-frequency currents. Check whether the patient has an electrically conductive implant and, if so, obtain qualified advice before using the generator. Operating the generator may cause concentration or redirection of high-frequency currents.
Interference with other equipment. During RF lesioning procedures, the radiated electrical fields may interfere with other electrical medical equipment. See "Minimizing Electromagnetic Interference" (page 5).
Shortwave or microwave equipment. Operation in close proximity to shortwave or microwave therapy equipment may produce instability in the applied parts.
Apparent low output or failure of equipment. If low output is observed or the equipment does not function correctly at normal operating setting, check the grounding pad and its connections.
Risk of patient injury. Do not use endoscopically. The accessories are not appropriate for endoscopic use.
Proper device use. Do not operate the generator if the alert tones are not audible after the volume is adjusted.
Non-sterile. The generator is non-sterile and should be kept outside of the sterile field.
Accessories. Use only accessories approved by Abbott Medical. See “Appendix C: System Components and Accessories” (page 42).
Continuity monitoring. The generator uses continuity monitoring. Loss of safe contact between the neutral electrode and the patient will result in an auditory alarm.
PRECAUTIONS
The following precautions apply to this generator.
Inspection. Inspect the generator and reusable accessories before each use. In particular, check the electrode cable insulation for possible damage.
Mechanical damage. If the equipment has suffered any mechanical damage, return it to the supplier for inspection and testing before further use.
Electrode positioning. Do not activate the generator output until the electrodes are correctly positioned in the patient.
Use of fluids. If fluids are being used during a procedure, ensure that they are positioned away from the generator.
Dispersive connections. Ensure that the grounding pad is connected to the patient and to the generator.
Cleaning the generator. When cleaning the outer casing or touchscreen, do not use abrasive agents or solvents. See "Cleaning the Generator" (page 32).
Emergency stop. For safety, always have someone positioned next to the Emergency Stop button during operation. If at any time the device is behaving erratically, press the Emergency Stop button, located on top of the generator, which will return the device to a safe state. For example, if the displayed temperature and graph do not match the desired set temperature.
Possible adverse events that may result from the use of this device include, but are not limited to, the following:
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Chronic Pain