StarBurst MRI Tech Sheet
Contents
1. 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 procedure 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 This product is MRI compatible to systems operating at 1 5 tesla or less MRI conditional 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 592. 13855 5928229 5935123 5980517 6071280 EP 0 777 445 B1 and Japanese patent 3009735 Other patents pending tt SurgEndosc E Berber NL Herceg KJ Casto amp AE Siper stein 2004 18 390 396 2013 AngioDynamics Inc MLC 387 US Rev A
3. StarBurst MRI RFA ELECTRODES StarBurst Radiofrequency Ablation Electrodes BENEFITS e Compatible with MRI use e A single device with the capability to produce scalable spherical ablations 3 5 cm e Patented expandable multi array space filling configuration e Reliable repeatable ablations e Multi point temperature feedback with dynamic real time readouts e Beveled surgical tip for easier penetration of hard tissue SPECIFICATIONS e Nine arrays plus active trocar tip e Five thermocouples H angiodynamics StarBurst MRI RFA ELECTRODES MRI Scalable Spherical Ablations 3 5 cm Diagram drawn to scale 4 Size cm Volume cm3 f 5 0t 655 N 40tt tt 33 5 3 0tt 144 t The Cannula tip should be 1 5 cm from the center of the ablation t t The Cannula tip should be 1 0 cm from the center of the ablation Product Name Length Part With Attached Cable Outer Diameter O D StarBurst MRI Electrode 10 cm 700 102441 700 103907 14 gauge 6 4 French StarBurst MRI Electrode 15 cm 700 102421 700 103906 14 gauge 6 4 French Main Cable Green 9 to 14 pin n a 700 101892 n a Pre attached Main Cable Main cable is pre attached for improved ease of use IMPORTANT RISK INFORMATION INDICATION FOR USE The StarBurst MRI 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 percutan
4. eous laparoscopic or intraoperative coagulation and ablation of soft tissue including the partial or complete ablation of non resectable liver lesions and palliation 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 gt 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
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