LumbarCool DFU
Contents
1. Probes only The LumsarCooL Introducer provides a path for the LumsarCooL Probe to the nervous tissue Kimperty CLark LumparCoot Cooled Radiofrequency Probe sterile single use It is inserted through a LumearCooL Introducer into or near nervous tissue Sterile water circulates internally to cool the LumsarCooL Probe while it delivers radiofrequency energy A thermocouple in the LumsarCooL Probe measures cooled electrode temperature throughout the procedure Indications for Use The Kimperty CLark LumsarCooL Cooled Radiofrequency Kit in combination with the Kimperty Cark Radiofrequency RF Generator PMG 115 TD PMG 230 TD formerly Baylis Pain Management Generator is indicated for use to create RF lesions in nervous tissue Contraindications For patients with cardiac pacemakers a variety of changes can occur during and after the treatment In sensing mode the pacemaker may interpret the RF signal as a heartbeat and may fail to pace the heart Contact the pacemaker company to determine if the pacemaker should be converted to a fixed rate pacing during the RF procedure Evaluate the patient s pacing system after the procedure Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the RF Generator If the patient has a spinal cord deep brain or other stimulator contact the manufacturer to determine if the stimulator nee2. order to return products under limited warranty you must have a return authorization number before shipping the products back to Kimberly Clark Limited Warranties Kimberly Clark warrants that these products are free from defects in original workmanship and materials If these products prove to be defective in original workmanship or original materials Kimberly Clark in its absolute and sole discretion will replace or repair any such product less charges for transportation and labor costs incidental to inspection removal or restocking of product This limited warranty applies only to original factory delivered products that have been used for their normal and intended uses Kimberly Clark s limited warranty shall NOT apply to Kimberly Clark s products which have been repaired altered or modified in any way and shall NOT apply to Kimberly Clark s products which have been improperly stored or improperly installed operated or maintained contrary to Kimberly Clark s Instructions The warranty period for Kimeerty CLark RF Probes and RF Generator Connector Cables is 90 days from the date of purchase unless otherwise stated Disclaimer and Exclusion of Other Warranties There are no warranties of any kind which extend beyond the description of the warranties above Kimberly Clark disclaims and excludes all warranties whether expressed or implied of merchantability or fitness for a particular use of purpose Limitation of Liability
3. readings are observed Use of damaged equipment may cause patient injury Do not modify Kimserty Cark Equipment Any modifications may compromise safety and efficacy of the device When the RF Generator is activated the conducted and radiated electrical fields may interfere with other electrical medical equipment The RF Generator is capable of delivering significant electrical power Patient or operator injury can result from improper handling of the Probes particularly when operating the device During power delivery the patient should not be allowed to come in contact with grounded metal surfaces Do not remove or withdraw the device while energy is being delivered Precautions Do not attempt to use the LumearCoo Kit before thoroughly reading the accompanying Instructions for Use and the User s Manual for the RF Generator and Kimper y CLark Dispersive Electrode PMA GP BAY Apparent low power output or failure of the equipment to function properly at normal settings may indicate 1 faulty application of the dispersive electrode or 2 power failure to an electrical lead Do not increase power level before checking for obvious defects or misapplication To prevent the risk of ignition make sure that flammable material is not present in the room during RF power application Only physicians familiar with RF lesion techniques should use the LumearCoo Kit components It is the physician s responsibility to determine assess
4. the pump to ensure the lid is not open Check RF Generator for any error messages Check that the connector s keys are lined up in the proper orientation Ensure that the connectors are clean and unobstructed Do not use Discard immediately Ensure the Tube Kit is correctly connected to the Probe Ensure the Tube Kit has been correctly placed in the pumphead Ensure the burette reservoir has been filled Visually inspect the Tube Kit tubing and joints for leaks and occlusions Ensure that the float ball in the burette is floating and not occluding the outflow of water from the burette Ensure the pump tubing thick walled tubing that is coming directly out of the bottom port of the burette is placed in the pumphead Check to see if water is running down the wall of the burette Close the pumphead lid Gently shake the burette to try and loosen the ball from the bottom of the burette Inject sterile water through the port of the lid rather than removing the lid Immediately discard the Tube Kit Customer Service and Product Return Information If you have any problems with or questions about Kimeerty CLark Medical Equipment contact our technical support personnel at the following address and or phone number Kimberly Clark 1400 Holcomb Bridge Road Roswell GA 30076 2199 Email InterventionalPain KCHC KCC COM U S Customers 800 KCHELPS 800 742 1996 International Customers 1 770 587 7200 Notes In
5. CH Kimberly Clark LumBarCoot Cooled Radiofrequency Kit Pain Management Instructions for Use D Kimberly Clark Trusted Clinical Solutions Pump Connector Cable LumearCoot Stylet Generator Tube Kit LumBarCooL Probe LumBaRCooL Introducer Cooled Radiofrequency Connector Cable Grounding Pad Monopolar System Sterile water injection port Luer Locks for connection of Tube Kit to LumsarCooL Probe 70 mL Mark Burette Reservoir Cooled Radiofrequency Sterile Tube Kit Inject sterile we AZ water into burette Remove lid and pour sterile TT ETI ig 3 Burette Placement in Pump Unit AN Placement of Tubing in the Pump Unit Fig 6 Do Not Use Attention See single STERILE EO If Package Rx Only Instructions for Use Use Only Is Damaged we Upper Limit Keep Away Dispose of of Temperature AL from Sunlight Properly 0086 T KIMBERLY CLARK LumearCoor Cooled Radiofrequency Kit Pain Management Federal Law USA restricts this device to sale by or on the order of a physician Device Description K mserLy CLark Cooled Radiofrequency Sterile Tube Kit sterile single use non body contact It is used for closed loop circulation of sterile water through a LumsarCooL Cooled Radiofrequency RF Probe It includes a burette and tubing K mserLY CLark LumgarCooL Cooled Radiofrequency Introducer sterile single use It is to be used with the LumsarCooL
6. and communicate to each individual patient all foreseeable risks of the RF lesion procedure The sterile packaging should be visually inspected prior to use to detect any compromise Ensure that the packaging has not been damaged Do not use the equipment if the packaging has been compromised Proper sterile techniques must be used when assembling and filling the Tube Kit Do not place the lid down on a non sterile surface Kimperty CLark Cooled Radiofrequency Sterile Tube Kit The Tube Kit is for use with a single LumsarCooL Probe Care must be taken to ensure all luer fittings are secure to prevent leaking Do not disconnect luer fittings while the pump is running Arrange equipment to minimize tubing tripping hazards Do NOT perform cooled RF lesion procedures if water is not circulating through the Tube Kit water is leaking or air bubbles are seen in the tubing Immediately stop the procedure and correct circulation before restarting the procedure Do NOT pinch the tubing of the Tube Kit Kimperty CLark LumparCoo Cooled Radiofrequency Introducer Be careful while handling the LumsarCooL Introducer The sharp tip can cause injury to the operator if handled carelessly Handle the Introducer safely when it is in use due to electric currents Do not move the Introducer without the stylet fully inserted Choose the properly sized Introducer Kimperty CLark LumparCoo Cooled Radiofrequency Probe The Tube Kit should never be d
7. ds to be in the bipolar stimulation mode or in the OFF position This procedure should be reconsidered in patients with any prior neurological deficit The use of general anesthesia is contraindicated To allow for patient feedback and response during the procedure it should be performed under local anesthesia Systemic infection or local infection in area of the procedure Blood coagulation disorders or anticoagulant use Warnings The LumsarCoot Kit contains single use devices Do not reuse reprocess or resterilize this medical device Reuse reprocessing or resterilization may 1 adversely affect the known biocompatibility of the device 2 compromise the structural integrity of the device 3 lead to the device not performing as intended or 4 create a risk of contamination and cause the transmission of infectious diseases resulting in a patient injury illness or death The LumsarCoor Probe must be used with the correct connector cable Attempts to use it with other connector cables can result in electrocution of the patient or operator Laboratory staff and patients can undergo significant x ray exposure during radiofrequency procedures due to the continuous use of fluoroscopic imaging This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects Therefore adequate measures must be taken to minimize this exposure Discontinue use if inaccurate erratic or sluggish temperature
8. ed with luer locks for connection to the LumsarCooL Probe The LumparCoo Probe LumearCoot Introducer and Tube Kit are ethylene oxide sterilized and supplied sterile The devices should be stored in a cool dry environment Note Please contact Kimberly Clark for a list of all model numbers and sizes Inspection Prior to Use The sterile packaging should be visually inspected prior to use to detect any compromise Ensure that the packaging has not been damaged Do not use the equipment if the packaging has been compromised Equipment Required Procedures should be performed in a specialized clinical setting equipped with a fluoroscopy unit The equipment required to perform RF procedures include LumBaRCooL Cooled Radiofrequency Probe LumBarCoo Cooled Radiofrequency Introducer s e Cooled Radiofrequency Peristaltic Pump Unit and Cable e Cooled Radiofrequency Sterile Tube Kit Cooled Radiofrequency Connector Cable Dispersive Electrode Radiofrequency Generator PMG 115 TD PMG 230 TD Instructions for Use Monopolar System Fig 1 Assemble all the equipment required for the procedure Set up the RF Generator PMG 115 TD PMG 230 1D and the Pump Unit as directed in their Instructions for Use Connect the Connector Cable to the RF Generator as described in its Instructions for Use Open the package in the sterile field using appropriate sterile techniques Inspect the devices visually to make sure there is no damage to them Do NOT
9. for Damages In any claim or lawsuit for damages arising from alleged breach of warranty breach of contract negligence product liability or any other legal or equitable theory the buyer specifically agrees that Kimberly Clark shall not be liable for damages for loss of profits or claims of buyer s customers for any such damages Kimberly Clark s sole liability for damages shall be limited to the cost to buyer of the specified goods sold by Kimberly Clark to buyer which give rise to the claim for liability The buyer s use of this product shall be deemed acceptance of the terms and conditions of these limited warranties exclusions disclaimers and limitations of liability for money damages
10. isconnected from the Probe when RF delivery is in progress The lumen of the Tube Kit should not be obstructed in any way during the procedure as this will stop cooling of the Probe Disconnect the Probe by pulling the connector not the cable Handle the Probe safely when it is in use due to electric currents and the hot tip While inserting the Probe through the LumearCoot Introducer watch the fluoroscope for any buckling Do not attempt to further insert the Probe if any buckling is observed or significant resistance is felt Do not move the LumsarCooL Introducer when the Probe is in it If repositioning is needed retract the Probe from the Introducer and then reposition the Introducer with the stylet inserted The Cooled RF Temp displayed on the RF Generator refers to the cooled electrode temperature and not the hottest tissue temperature Adverse Events Potential complications associated with the use of this device include but are not limited to infection nerve damage increased pain visceral injury failure of technique paralysis and death Product Specifications The LumearCoo Probe is comprised of an electrically insulated shaft with an active tip that functions as an electrode for RF energy delivery a handle tubes with luer locks and a cable with a 7 pin connector The LumsarCooL Introducer includes an insulated stainless steel cannula and a stylet The Tube Kit is comprised of a burette and flexible tubing fitt
11. perform the procedure with any damaged equipment Cooled Radiofrequency Sterile Tube Kit Fig 2 1 Place the burette into the burette holder on the side of the Pump Unit The side of the burette with 2 or 3 ports indicates the top of the burette Fig 3 2 Fill the burette with room temperature sterile water Use sterile handling techniques Fill the burette to the 70 mL mark Burette can be filled by injecting sterile water through a port in the lid or by temporarily removing the lid and pouring sterile water in Warning BE SURE TO FILL THE BURETTE TO THE 70 mL MARK Not filling the burette to the 70 mL mark will result in an inadequate supply of water for circulation Use ONLY sterile room temperature water Ensure the lid is snapped back onto the body of the burette after filling Inject sterile water into burette OR remove lid and pour sterile water Fig 4 5 3 Place the thick walled tubing coming out of the bottom of the burette into the pumphead of the Pump Unit Place the tubing in the channels of the L shaped bracket to ensure that the tubing is not obstructed while closing the pumphead Close the lid on the pumphead to clamp down on the tubing Fig 6 4 Remove the caps on the male and female luer locks Connect the appropriate luer lock to the corresponding luer lock on the Probe Do not over tighten the connection Caution Connect one Tube Kit to one LumsarCooL Probe Fig 7 5 Atthe end of the procedure disca
12. rd the Tube Kit appropriately LumearCooi Cooled Radiofrequency Introducer 1 With the stylet in the Introducer carefully insert the Introducer into the patient using fluoroscopic guidance to place it at the desired lesion location 2 Once the Introducer is in the proper position carefully remove the stylet from the Introducer 3 Repeat steps 1 2 with a second Introducer if necessary LumearCooi Cooled Radiofrequency Probe 1 Insert the Probes into the tissue through the Introducer Never force the Probe in if significant resistance is felt 2 Attach the dispersive electrode to the RF Generator and place the dispersive electrode pad on the patient as directed in the Instructions for Use and User s Manual accompanying the package 3 Connect the Probe to the Tube Kit 4 Connect the 14 pin connector of the Connector Cable into the RF Generator Connect the Probe to the 7 pin connector on the Connector Cable 5 Select the Treatment mode in the RF Generator Set advanced settings and the parameters for RF delivery in the RF Generator as described in the User s Manual 6 Perform the procedure as described in the RF Generator User s Manual The procedure comprises pre cooling treatment and optional post cooling stages Note Other than reproduction of their usual referred pain or irritation due to Probe introduction monitor the patient for unexpected symptoms that may indicate for example spinal cord or nerve root irrita
13. tion If these indications are suspected discontinue energy delivery 7 After treatment remove the Probes and the Introducer and discard as biohazards Remove the Dispersive Electrode from the patient and discard appropriately Disconnect the Connector Cable from the RF Generator Follow standard hospital techniques to handle reusable items Troubleshooting The following table is provided to assist the user in diagnosing potential problems PROBLEM No temperature measurement OR Inaccurate erratic or sluggish temperature reading Water does not flow through the Probe and Tube Kit Probe Connector does not fit in Probe Plug in Damage to Insulation on Probe or Introducer Water is not circulating through tubing during LumearCooL pre cooling ON and post cooling states Water is not dripping into the burette Float is stuck on bottom port of the burette The lid of the burette cannot be removed Tube Kit breaks is leaking or is occluded TROUBLESHOOTING Ensure all connections are made Probe s to Connector Cable Connector Cable to the RF Generator RF Generator to power outlet Check for an error message on the RF Generator Visually inspect the Probe or Cable for damage Ensure that devices are dry and at room temperature If problem persists discontinue use Stop the procedure immediately Check the luer lock connections to ensure the Tube Kit is connected to the Probe Check
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