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Nimbus Essential Product Info

Nimbus Essential Product Info

Indications For Use:

The Nimbus Electrosurgical RF Multitined Expandable Electrode is intended for use in radio frequency (RF) heat lesion procedures for relief of pain.

Description:

The Nimbus Electrosurgical RF Multitined Expandable Electrode consists of an insulated cannula with an active tip for use in RF heat lesion procedures for the relief of pain. The active tip contains deployable tines that are advanced via the spin collar and determines the size of the RF lesion. The Nimbus Electrosurgical RF Multitined Expandable Electrode is sterilized and intended for single use only.

Features:

  1. The Nimbus Electrosurgical RF Multitined Expandable Electrode has a rigid cannula with a tip that can be used for insertion into target tissues and is capable of placement via radiography and traditional motor/sensory stimulation protocols.

  2. The Nimbus Electrosurgical RF Multitined Expandable Electrode contains an active tip with expandable needle electrodes (tines) that can be deployed with the spin collar.

Lesion Formation:

The Nimbus Electrosurgical RF Multitined Expandable Electrode consists of an insulated cannula with an active tip for use in RF heat lesion procedures for the relief of pain. The active tip transfers RF energy to the target tissue and consists of the needle tip, the deployable tines, and the uninsulated portion of the cannula. A representative diagram of a 10mm Nimbus Electrosurgical RF Multitined Expandable active tip is shown in Figure 1a.

During the ablation procedure, the RF heat lesion propagates from the active surface of the electrode as dictates by the current density distribution. A graphical representation of a typical heat heat lesion formed using a 10mm Nimbus Electrosurgical RF Multitined Expandable Electrode active tip is shown in Figure 1b. Figure 1c. provides a cross sectional diagram of a representative isotherm distribution during the creation of a lesion using a 10mm Nimbus Electrosurgical RF Multitined Expandable Electrode active tip.

Warnings:

  1. Do not use if damage to the device or insulation is noted as tissue damage or electrical leakage could occur which could lead to patient or user injury.

  2. Do not use if the package has been opened or damaged.

  3. Always fully insert the probe into the cannula. Failure to comply will prevent proper placement of the tip of the probe and may result in patient injury.

  4. Always ensure that the correct RF probe and generator are used with the device. The Nimbus Electrosurgical RF Multitined Expandable Electrode is rated for use in high frequency lesions up to 850 volts and may only be used with compatible Pain Management Generators with a maximum voltage rating less than or equal to 850 volts. See equipment list below for compatible generators.

  5. Do not attach anything (e.g., hemostats, clamps, etc.) to the device. This may damage the device or its insulation which could lead to patient or user injury.

  6. Do not bend or kink the electrode or the tines. This may cause damage to the product and result in reduced functionality or tissue damage during insertion or removal.

  7. Do not modify the Nimbus Electrosurgical RF Multitined Expandable Electrode. Any modifications may compromise the safety and effectiveness of the device.

  8. Take care when handling as electrode and tines can cause injury.

  9. Do not remove the device without ensuring that the tines are fully retracted within the cannula. If abnormal removal force is experienced during removal of the tines, check to ensure tines are fully retracted.

  10. Patients with vascular deficiency are at increased risk of thermal injury from dispersive electrodes.

  11. Patients with frail skin are at increased risk of skin damage from the adhesive on the dispersive pads.

  12. Refer to warnings in RF generator manual.

  13. Federal Law (USA) restricts this device to sale by or on the order of a physician.

  14. The entire area of the neutral electrode (grounding pad) should be reliably attached to a suitably prepared and appropriate
    area of the patient’s body during heat ablation for pain management.

  15. During the procedure, the patient should not come in contact with metal objects which are earthed or which have an appreciable capacitance to earth (e.g. operating table supports, etc.).

  16. The patient leads should be positioned in such a way that contact with the patient or other leads is avoided. Unused active electrodes should be temporarily stored in a location that is isolated from the patient.

  17. Apparent low output or failure of the RF surgical equipment to function correctly at the normal operating settings may indicate faulty application of the neutral electrode (grounding pad) or poor contact with its connections. In this case, the application of the neutral electrode (grounding pad) and its connections should be checked before selecting a higher output power.

  18. Failure of the RF surgical equipment could result in an unintended increase of output power.

  19. Neuromuscular stimulation modes have a risk of producing electrical arcs between RF electrodes and tissue.

  20. The Nimbus Electrosurgical RF Multitined Expandable Electrode is not for use in the central nervous system.

Precautions:

  1.  The safety of electrosurgery will be greatly enhanced by a thorough knowledge of the medical literature on the subject. Study of specific information on the hazards and complications of the procedure in question is especially recommended.

  2. The power applied by the RF generator should be kept to the minimum necessary to achieve the desired clinical effect.

  3. If retraction/removal of the device is difficult, do not exert additional force. Infuse small amounts of saline and gently retract the tines. It may be necessary to alternately retract and deploy the tines in order to free the tissues. The saline will soften coagulated tissues and allow for tine retraction.

  4. The Nimbus Electrosurgical RF Multitined Expandable Electrode is a single-use device. It should not be cleaned, re-sterilized, or re-used. Reuse can cause patient injury and/ or communication of infectious disease(s) from one patient to another.

  5. Contamination of the device may lead to injury, illness or death of the patient.

  6. Reprocessing may compromise the integrity of the device and/or lead to device failure.

  7. The Nimbus Electrosurgical RF Multitined Expandable Electrode has NOT been demonstrated compatible with magnetic resonance imaging (MRI). Use of MRI in conjunction with this device may lead to patient or user injury.

  8. Never use electrosurgical devices in the presence of flammable liquids, gases or oxidizing agents. The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Precautions must be taken to avoid contact of flammable materials and substances with electrosurgical electrodes.

  9. The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away.

  10. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate beforethe use of RF surgery. There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluidpooled in these areas should be removed before RF surgical equipment is used. Attention should be called to the danger of ignition of endogenous gases. Some materials, for example cotton and gauze, when saturated with oxygen, may be ignited by sparks produced in normal use of the RF surgical equipment.

  11. As necessary, clean the electrode tip between placements by rinsing the tip in sterile solution and gently wiping the tip to remove excess tissue. Use caution not to use an abrasive substance that may cause damage to the insulation. Accumulation of excess tissue on the tip may make electrode and/or tines removal difficult.

  12. Safe use of the device requires adequate separation between the thermal lesion and adjacent anatomical structures. Skin-to-skin contact (i.e. arms and body of patient, etc.) should be avoided during the procedure. For example, this can be avoided by insertion of dry gauze.

Contraindications:

  1. For patients with cardiac pacemakers, a variety of changes can occur during and after the treatment. In sensing mode the pacemaker may interpret the RF signal as a heartbeat and may fail to pace the heart. Contact the pacemaker company to determine if the pacemaker should be converted to a fixed-rate pacing during the RF procedure. Evaluate the patient’s pacing system after the procedure.

  2. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the RF lesion generator.

  3. If the patient has a spinal cord stimulator contact the manufacturer to determine if the stimulator needs to be in the bipolar stimulation mode or in the OFF position. When RF surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from surgical electrodes. Tine monitoring electrodes are not recommended. In all cases, monitoring systems incorporating RF current limiting devices are recommended. Interference produced by the operation of RF surgical equipment may adversely influence the operation of other electronic equipment.

  4. The NIMBUS electrode has NOT been demonstrated compatible with magnetic resonance imaging (MRI). Use of MRI in conjunction with this device may lead to patient or user injury.

  5. The use of general anesthesia is contraindicated. To allow for patient feedback during the procedure, it should be performed under local anesthesia.

  6. For surgical procedures where the RF current could flow through parts of the body having a relatively small cross sectional area, the use of bipolar techniques may be undesirable in order to avoid unwanted tissue damage.

Equipment List:

RF Lesion procedures should be performed in a specialized clinical setting equipped with a fluoroscopy unit. The equipment required to perform RF procedures is as follows:

• Nimbus Electrosurgical RF Multitined Expandable Electrode
• Pain Management Probes
• Pain Management Generator*
• Pain Management Connector Cables
• Pain Management Dispersive Pads

*Note: The Nimbus Electrosurgical RF Multitined Expandable Electrode is rated for use in RF lesion creation up to 850 volts and may only be used with compatible pain management generators with a maximum voltage rating less than or equal to 850 volts.

Instructions for Use:

Pending completion of all patient preparation, the following procedure is the recommended operation for the device.

  1. Inspect product packaging. If sterile barrier or device are in any way compromised, do not use.

  2. Under sterile procedure, open package by peeling pouch at the chevron end.

  3. Remove protective sheath over electrode and tines.

  4. Inspect device prior to use. DO NOT USE if the device is damaged.

  5. Verify that the tines mechanically deploy and that the RF Generator goes through its self-check per the generator’s user manual.

  6. Before inserting the device into tissue, ensure that the tines are fully retracted into the cannula by rotating the Spin Collar. Rotation of the collar will retract the tines without other force being applied.

  7. Insert the device to desired location under radiography. Perform traditional sensory/motor stimulation protocols to ensure safe placement.

  8. Insert the RF probe into the connector lumen of the device. If significant resistance or force is required to insert the probe do not force assembly. Use a repeated push and turn process to attempt to align the probe with the probe lumen. Probe should seat fully and bind with the connector.

  9. Deploy tines by rotating Spin Collar until Advancing Hub can be seen aligned with the “T” shaped deployment indicator on the Main Hub. Ensure that the RF probe remains fully seated in the connector.

  10. When ready to apply therapeutic RF energy, verify that the RF Generator is running a program appropriate to achieve the desired clinical effect.

  11. Start RF power via prescribed therapy.

  12. Upon completion of therapy, fully retract the tines by rotating the Spin Collar.

  13. Remove the electrode from the tissue by pulling on the Main Body of the device.

  14. Reinsert electrode and tines as needed to achieve desired clinical result.

  15. Dispose of device per hospital or clinic protocol for “sharps” and/or “biohazards.”

Please contact company with name, facility and email address to request complete IFU.

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