COBLATION™ PROCISE™ MLW
Contents
1. COBLATION PROCISE MLW Laryngeal Wand COBLATION plasma technology for laryngeal lesions and tracheal procedures The PROCISE MLW laryngeal Wand provides pinpoint ablation and coagulation capabilities Surgical technique COBLATOR Il surgery system setup 1 Set up the COBLATOR II system and the PROCISE MLW laryngeal Wand according to the Controller User s Manual and Wand Instructions for Use IFU Note This guide is not intended to replace the COBLATOR User s Manual or Wand IFU Thoroughly review the User s Manual and Wand IFU before installing or operating this system 2 Default settings Coblate 7 Coag 3 Adjust as needed and per surgeon preference The ultra slim 3 Connect the Wand s suction tubing to an OR suction source separate from any other suction r snait 01 the instrumentation Suction should be set to approximately 250mmHg PROCISE MLW Wand provides 4 Connect the Wand s saline tubing to bag of normal saline and adjust saline flow to a minimum gt ccess to the trachea intermittent drip making it well suited for operating on small Patient other preparation anatomy 1 To ensure optimal visualization throughout the procedure the Wand can be used with standard laryngoscopes and microscopes Use the largest laryngoscope that can be accommodated Those with proximally and distally adjustable blades are particularly useful 2 Standard cuffed microlaryngeal tubes a2. ates present References Smith LP Roy S Operating room fires in otolaryngology risk factors and prevention Am J Otolaryngol Article in press Epub 2010 Apr 14 Roy S Smith LP Device related risk of fire in oropharyngeal surgery a mechanical model Am J Otolaryngol 2010 Sept 31 5 356 359 This article references preclinical non human data As such results may not necessarily be the same in human procedures Matt BH Cottee LA Reducing risk of fire in the operating room using COBLATION technology Otolaryngol Head Neck Surg 2010 Sept 143 3 454 5 Data based on tongue tissue in an animal model results may not be the same in humans Data on file report 35764 01 Data based on vocal fold study in an animal model results may not be the same in humans Data on file report 35766 01 ArthroCare Corporation www smith nephew com 7000 West William Cannon Drive Austin TX 78735 USA Order Entry 1 800 797 6520 Order Entry Fax 1 888 994 2782 2014 Smith amp Nephew Inc Trademark of Smith amp Nephew Reg US Pat amp TM Office P N 45403 Rev C 11 14
3. ment 2 Press the ablation pedal yellow of the Foot Control to activate the Wand Make brief contact 1 2 seconds with target tissue through the use of a dabbing motion Continue ablation briefly after removing the tip from target tissue to allow digestion of any tissue on the electrode surface Deactivate the Wand by taking your foot off the foot pedal Caution Keep the active electrode directly facing target tissue User should always pay close attention to the position of the PROCISE MLW Wand and to its proximity to surrounding untargeted tissue Ensure non targeted tissue does not contact the exposed metal of active or return electrodes Do not bend the Wand shaft or rub the Wand tip against target tissue during ablation as this could result in clogging of the suction line Do not use the Wand suction line as a standard surgical suction device to clear debris from the surgical field as this could result in clogging of the suction line 3 To coagulate tissue position Wand tip directly over the source of bleeding and depress the Coagulation pedal blue Thermal effect Histology animal model 600 500 400 300 200 100 0 Default COBLATE setting Default COBLATE setting Day 3 Day 21 Depth um Default coblate Maximum coblate Default coag Device settings At Day 21 all vocal fold lesions were 100 epithelialized in canine model Gross appearance of vocal fold lesions was fully healed with no exud
4. re adequate for protection of the lower airways from any excess Saline This can be aided by gentle packing above the balloon with wet cottonoids Chance contact of the COBLATION Wand with the tube will not cause damage to the airway tube Note Recent studies about airway fires suggest that using COBLATION technology in place of traditional electrosurgical or laser devices during oropharyngeal surgery significantly reduces the risk of igniting an airway fire due to the low heat generated and the lack of spark or ignition medium under normal operating circumstances Special endotracheal tubes used with lasers are not necessary Venturi ventilation has also been used successfully in conjuntion with COBLATION technology A head down Trendelenberg position should be utilized to ensure any excess saline flows into the pharynx and not in the trachea Coblator II COBLATION 2 14 From ArthroCare EXT Procedure 1 To ablate tissue position Wand tip in close proximity to target tissue Caution Care should be taken in monitoring the targeted tissue during ablation to ensure consistent and controlled tissue removal is achieved Care should also be taken to ensure surrounding tissue is properly monitored Due to the smaller anatomies of certain patients carefully monitor the surrounding tissues to ensure tissue ablation is localized to the targeted tissue Before COBLATION technology treatment After COBLATION technology treat
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