Simplicity™ III Disposable Radiofrequency Electrode

Prescription and Safety Information

Read this section to gather important prescription and safety information.

INDICATION FOR USE

The Abbott Medical Simplicity™ III Disposable Radiofrequency Electrode is intended for use in the treatment of chronic pain by the ablation of neural tissue.

DESCRIPTION

The Simplicity III electrode is a disposable radiofrequency (RF) device consisting of three isolated electrodes along the shaft. Radiopaque markers are located between the distal and the middle electrodes, between the middle and the proximal electrodes, and below the proximal electrode. These radiopaque markers clearly show the separation of the three electrodes under X-ray. The Simplicity III electrode needs to be connected to an Abbott Medical RF generator using an Abbott Medical adapter cable.

WARNINGS

• Sharp; handle carefully.
• Do not proceed unless all electrodes read body temperature when connected and inserted into the patient.
• Stop if heat is felt at site of the grounding pad.
• When the Simplicity III electrode is used to perform lesion procedures in the sacral region, always ensure that the electrode does not enter any of the sacral foramen and that the electrode does not proceed inferior to the inferior border of the sacrum.
• Do not use the electrode if the package has been opened or damaged.
• Ensure the most proximal contact on the electrode is not too close to the dermis to prevent skin burn.
• Use of general anesthesia is not recommended during the procedure. It is advised to use local anesthesia or conscious sedation so patient interaction is possible.
• The electrode should only be used by physicians trained in the use of the device.
• The electrode is intended for single-use only. This device is not intended for bilateral use.
• The electrode should only be used with an Abbott Medical RF generator.
• During treatment with the Simplicity III electrode, the patient should continuously be monitored and evaluated for any unexpected symptoms.
• Before starting any thermal treatment with the electrode, ensure no motor nerves are in the vicinity of the electrode.
• Do not move the electrode while it is activated.
• Do not use the electrode if any damage is observed.
• Do not bend or reshape the electrode; this can cause permanent mechanical damage.
• Use minimal force and torque when manipulating the electrode; the handle has been designed to release if too much torque is applied. 
• Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
• Reprocessing may compromise the structural integrity of the device and/or lead to device failure.
• Cleaning, disinfection, and sterilization may compromise essential material and design characteristics, leading to device failure.

MAT-2006979 v1.0