StarBurst SDE Tech Sheet
Contents
1. StarBurst Radiofrequency Ablation Electrodes StarBurst SDE RFA ELECTRODES BENEFITS e Straight needle with side deployed arrays e Small needle gauge and sharper trocar tip for easier access into the lesion site e Smaller spherical ablations 2 cm e Dynamic real time temperature readouts e Multi point temperature feedback e Patented side deployment array design SPECIFICATIONS e Three arrays plus active trocar tip e Three thermocouples angiodynamics StarBurst SDE RFA ELECTRODES SDE Scalable Spherical Ablations 2 cm Diagram drawn to scale Size cm 20t Volume cm3 t4 2 t The Cannula tip should be 1 5 cm from the center of the ablation t The Cannula tip should be 1 0 cm from the center of the ablation Product Name Length Part Outer Diameter O D StarBurst SDE Electrode 12 cm 700 102486 17 gauge 4 5 French StarBurst SDE Electrode w attached cable 12 cm 700 103908 17 gauge 4 5 French Pre attached Main Cable Main cable is pre attached for improved ease of use IMPORTANT RISK INFORMATION INDICATION FOR USE The StarBurst SDE Electrosurgical Device is a tool to transmit monopolar radiofrequency energy provided by the RITA 1500 or 1500X RF Generator and is indicated for use in percutaneous laparoscopic or intraoperative coagulation and ablation of soft tissue including the partial or complete ablation of non resectable liver lesions and palli2. ation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy WARNINGS AND PRECAUTIONS For single use only Do not bend or kink the trocar or the needles do not attach anything i e clamps etc to the Device or use metal introducers that do not have insulation inadvertent patient injury may result To ensure safe angiodynamics Model 1500X RF Generator The Model 1500X RF Generator is designed specifically for use with RITA electrosurgical devices It is the latest radiofrequency generation system that features technological advances including software upgrade capabilities potential for 250 watts of power and three flexible serial ports and effective use follow the manufacturer s directions and recommended practices for the preparation placement surveillance removal and use of the dispersive electrode To achieve the desired ablation follow the manufacturer s guidelines of ablation time and temperature Ensure that the device is placed at least 1 cm away from structures not intended for ablation In laparoscopic procedures care must be taken to avoid a gas embolism and activation of the device when not in contact with target tissue may cause capacitive coupling In some cases a liver lesion will only be partially destroyed the final determination of the success of lesion destruction can only be made by imaging studies following the proced
3. ure and during regular long term follow up For ablation of painful USA gt 14 Plaza Drive Latham NY 12110 gt tel 800 772 6446 or 518 798 1215 gt fax 518 798 1360 International gt Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O gt The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com AngioDynamics the AngioDynamics logo StarBurst and RITA are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary bone metastases do not perform RF ablation in weight bearing bone with evidence of impending fracture Pathologic fracture is more prevalent and serious in long bone Please see package insert for complete list of warnings and precautions Refer to individual product IFUs and or User Manual to see full Warnings Precautions Possible Adverse Effects and Contraindications Observe all instructions prior to use Failure to do so may result in patient complications CAUTION Federal USA law restricts this device to sale by or on the order of a physician t Covered by one or more of the following US patents 5472441 5486161 5536267 5672173 5672174 5683384 5728143 5782827 5863290 5913855 5928229 5935123 5980517 6071280 EP 0 777 445 B1 and Japanese patent 3009735 Other patents pending 2013 AngioDynamics Inc MLC 389 US Rev A
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