User`s guide

AngioDynamics, Inc. Model 1500X User’s Guide and Service Manual
160-103990 Rev 03 Page 6
Follow directions and recommended practices for the preparation, placement,
surveillance, removal and use of any Dispersive Electrode used with this RF
Generator in accordance with your facility’s standard operating procedure, the
Dispersive Electrode’s Instruction for Use, and AAMI standards.
• Patients with peripheral vascular deficiency are at increased risk of thermal injury
from Dispersive electrodes.
• Patients with frail skin are at increased risk of skin damage from the adhesive on the
Dispersive pads.
• Having RF power on at the same time as infusion, using a method different from the
instructions in this document and accompanying the Disposable Electrosurgical
Device, may alter the path of the electrical energy away from target tissues.
• It is important to carefully evaluate all candidates for this procedure for proximity of
the intended ablation site to critical structures. As with all electrosurgical procedures,
there is a risk of injuring adjacent structures. Ensure that device placement is at
least 1 cm away from structures not intended for ablation. PROXIMITY TO NERVE
STRUCTURES IS PARTICULARLY CRITICAL. SERIOUS COMPLICATIONS
SUCH AS INCONTINENCE CAN OCCUR IF THESE CRITICAL STRUCTURES
ARE DAMAGED DURING THE RF ABLATION PROCEDURE.
3.5 Warnings and Precautions Specific to the Ablation of Non-
resectable Liver Lesions
• Incomplete ablation – In some cases, the lesion will only be partially destroyed. The
final determination of the success of lesion destruction can only be made by imaging
studies following the procedure and during regular long-term follow-up.
3.6 Warnings and Precautions Specific to the Ablation of Painful
Bone Metastases
• It is important to carefully evaluate all candidates for this procedure for evidence of
impending fracture, particularly in weight-bearing bone. Do not perform RF ablation
of metastases in weight-bearing bone with evidence of impending fracture.
• Pathologic fracture is more prevalent and serious in long bone. The study conducted
did not have a significant number of patients with metastases involving long bones;
therefore, the study may not give an accurate estimate of the fracture rate after
treatment for patients with metastases involving long bone.
• Since bone metastases occur at various locations in the skeleton, the proper
placement of the dispersive electrodes may vary. Dispersive electrodes should be
oriented with the longest edge toward the target ablation site with 25 – 50 cm
distance between the ablation site and dispersive electrodes. Dispersive electrodes
should be equivalent distances from the active electrode in order to minimize the risk
of a skin burn. (See Dispersive Electrode’s Instruction for Use for examples of
dispersive electrode placement locations.)
• Beyond four weeks, the durability of pain relief after using this device to ablate
painful bone metastases has not been established.