TransDiscal DFU
Contents
1. Kit components It is the physician s responsibility to determine assess 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 TransDiscat 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 C ark TransDiscat Cooled Radiofrequency Introducer Be careful while handling the TransDiscat 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 remove or withdraw the Introducer while energy is being delivered Do not move the Introducer without t2. The following table is provided to assist the user in diagnosing potential problems TROUBLESHOOTING No temperature Ensure that all connections are made measurement in Probe s to Y Connector Cable treatment mode Y Connector Cable to the RF Generator OR e RF Generator to power outlet Inaccurate erratic or Check for an error message on the RF sluggish temperature Generator reading in treatment mode Visually inspect the Probe or Cable for damage Ensure that devices are dry and at room temperature If problem persists discontinue use PROBLEM Water does not flow through TransDiscat Probe and Tube Kit Stop the procedure immediately Check the luer lock connections to ensure the Tube Kit is connected to the TRANSDIscAL Probe Check the Pump to ensure the lid is not open Check RF Generator for any error messages Probe connector does not fit in Probe plug in Check that the connector s keys are lined up in the proper orientation Ensure that the connectors are clean and unobstructed Damage to insulation on TransDiscat Probe or Introducer Do not use Discard immediately TROUBLESHOOTING Ensure the Tube Kit is correctly connected to the Probe Ensure the Tube Kit has been placed in the pumphead and that it is correctly located in the L shaped tube guides Ensure the burette reservoir has been filled Visually inspect the Tube Kit tubing and joints for leaks and occlusions Ensur
3. slightly This value is not to be used to assess the hottest tissue in the disc periphery 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 TransDisca Probe is comprised of an electrically insulated shaft with a active tip that functions as an electrode for RF energy delivery a handle tubes with luer locks and a cable with a 5 pin connector The TransDisca Introducer includes an insulated stainless steel cannula and a stylet The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for connection to the TransDiscal Probe The kit components 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 in the disc should be performed in a specialized clinical setting equipped with a fluoroscopy unit The equipment required to perform RF procedures include TransDiscal Cooled Radiofrequency Probe s e TransDiscat Cooled Radiofrequency I
4. 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 After filling ensure the lid is snapped back onto the body of the burette it was removed from It is important that the lid corresponds to the original burette body it was removed from do not mix up the lids Inject sterile water into burette Fig 4 OR remove lid and pour sterile water Fig 5 3 Place the thick walled tubing coming out of the bottom of the burette into the pumphead of the Pump Unit Fig 6 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 4 Remove the caps on the male and female luer locks Connect the appropriate luer lock to the corresponding luer lock on the TransDiscat Probe Fig 7 Do not over tighten the connection Caution Connect one Tube Kit to one TransDiscat Probe 5 Atthe end of the procedure discard the Tube Kit appropriately Kimperty C ark TransDiscar Cooled Radiofrequency Probe 1 Insert the TransDisca Probes in the intervertebral disc through the Introducers Never for
5. CH Kimberly Clark TRANSDISCAL Cooled Radiofrequency Kit Pain Management Instructions for Use D Kimberly Clark Trusted Clinical Solutions Sterile water injection port Luer Locks for connection of Tube Kit to TransDiscat Probe 70 ml Mark Pump Connector Cable Burette Reservoir Cooled Radiofrequency Sterile Tube Kit Tube Kit Probe E C TransDiscaL Trans DiscaL Ls Introducer Y Connector Cable TRANSDISCAL Introducer Tube Kit Trans DiscaL Probe System Schematic Inject sterile water into burette Remove lid and pour sterile water Fig 5 Placement of Tubing in the Pump Unit Fig 6 Single Use Only Do Not Use STERILE EO Q If Package Is Damaged M Attention See gt lt Keep Away Dispose of Instructions for Use A from Sunlight Properly T KIMBERLY CLARK TransDiscat Cooled Radiofrequency Kit Pain Management Federal U S A law restricts this device to sale by or on the order of a physician Device Description Kimperty CLark TransDiscat Cooled Radiofrequency Introducer sterile single use It is to be used with the Kimber y CLark TransDiscat Cooled Radiofrequency Probes only The TransDisca Introducer provides a path for the TransDiscat Probe to the disc Kimperty CLark TransDiscac Cooled Radiofrequency Probe sterile single use
6. It is inserted through a TransDisca Introducer into the intervertebral disc Sterile water circulates internally to cool the TransDiscat Probe while it delivers radiofrequency RF energy Thermocouples in the TransDiscaL Probe measure cooled electrode temperature throughout the procedure Kimperty CLark Cooled Radiofrequency Sterile Tube Kit sterile single use non body contact It is used for closed loop circulation of sterile water through a TransDiscat Probe It includes a burette and tubing Indications For Use The Kimper y CLark TRansDiscaL Cooled Radiofrequency Kit in combination with the Kimperty Cark Radiofrequency Generator PMG 115 TD PMG 230 TD formerly Baylis Pain Management Generator is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs 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 radiofrequency 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 patien
7. ce the TransDisca Probe in if significant resistance is felt 2 Connect the TransDiscat Probe to the Tube Kit 3 Connect the TransDisca Probes to the TransDisca Y Connector Cable If the option of one TransDiscat Probe has been enabled in the RF Generator connect the TransDisca Probe to TransDiscaL Probe A side of the TransDiscat Y Connector Cable 4 Select the Treatment Mode in the RF Generator Set advanced settings and the parameters for RF delivery in the RF Generator as described in its User s Manual 5 Perform the procedure as described in the RF Generator User s Manual The procedure comprises pre cooling treatment and post cooling stages 6 Temperatures at the tip of the electrode and 3 mm proximal to the electrode of the TransDiscat Probe are monitored throughout the procedure by the RF Generator Note Other than reproduction of their usual back pain or irritation due to TransDiscaL Probe introduction monitor the patient for unexpected symptoms that may indicate for example spinal cord or nerve root irritation If these indications are suspected discontinue energy delivery 7 After post cooling remove the TransDiscat Probes and the Introducer and discard as biohazards If used remove the Dispersive Electrode from the patient and discard appropriately Disconnect the TransDiscat Y Connector Cable from the RF Generator Follow standard hospital techniques to handle reusable items Troubleshooting
8. e 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 Water is not dripping Check to see if water is running down the wall into the burette of the burette Tubing cannot be Open the pumphead lid fully and place the placed in the pump tubing above the L shaped guides Close the pumphead lid Gently shake the burette to try and loosen the ball from the bottom of the burette PROBLEM Water is not circulating through tubing during TransDisca pre cooling ON and post cooling states Float is stuck on bottom port of the burette Check to see that male and female luer locks are properly connected Immediately discard the Tube Kit Customer Service and Product Return Information If you have any problems with or questions about this KimBerty CLark Equipment contact our technical support personnel Kimberly Clark 1400 Holcomb Bridge Rd Roswell GA 30076 2199 E mail InterventionalPain KCHC KCC COM U S Customers 800 KCHELPS 800 742 1996 International Customers 1 770 587 7200 Tube Kit cannot be connected to Probe Tube Kit breaks is leaking or is occluded Notes In order to return products under limited warranty you must have a return authorization number before shipping the products back to Kimberly Clark Limit
9. easures must be taken to minimize this exposure Discontinue use if inaccurate erratic or sluggish temperature 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 TransDiscat 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 TransDiscat Kit before thoroughly reading the accompanying Instructions for Use and the User s Manual for the RF Generator 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 TransDisca
10. ed 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 Kimerty 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 for Damages In any claim or lawsuit for damages arising from alleged breach of warranty breach of contract negligence product liability or any other l
11. egal 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
12. he stylet fully inserted Kimperty CLark TransDiscat Cooled Radiofrequency Probe The Tube Kit should never be disconnected from the TransDisca 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 TRANSDIScAL Probe Disconnect the TransDiscat Probe by pulling the connector not the cable Handle the TransDisca Probe safely when it is in use due to electric currents and the hot tip While inserting the TransDiscat Probe through the TransDiscat Introducer watch the fluoroscope for any buckling Do not attempt to further insert the TransDiscaL Probe if any buckling is observed or significant resistance is felt Confirm the placement of the TransDiscal Probe in the disc with fluoroscopy Do not apply RF energy if any segment of the TransDiscat Probe distal to the Introducer is outside the intervertebral disc wall Do not move the TransDiscat Introducer when the TransDiscat Probe is in it If repositioning is needed retract the TransDisca Probe from the Introducer and then reposition the Introducer with the stylet inserted The TransDisca Temp displayed on the RF Generator refers to the cooled electrode temperature and not the hottest tissue temperature The Peripheral Disc Temp displayed on the RF Generator refers to the temperature of the TransDiscal Probe shaft 3 mm proximal from the electrode and is cooled
13. ntroducer s Cooled Radiofrequency Peristaltic Pump Unit and Cable Cooled Radiofrequency Sterile Tube Kit s gt TransDisca Cooled Radiofrequency Y Connector Cable e Dispersive Electrode Radiofrequency Generator PMG 115 TD PMG 230 TD Instructions For Use Fig 2 Figure 2 is a schematic representation of the connections of the system Assemble all the equipment required for the procedure Set up the Radiofrequency Generator PMG 115 TD PMG 230 TD and the Pump Unit as directed in their Instructions for Use Connect the TransDiscat Y 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 perform the procedure with any damaged equipment Kimperty C ark TransDiscat Cooled Radiofrequency Introducer 1 Carefully insert the Introducer with the stylet in it into the intervertebral disc under fluoroscopic guidance 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 Kimperty CLark Cooled Radiofrequency Sterile Tube Kit Fig 1 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
14. t has a spinal cord deep brain or other stimulator contact the manufacturer to determine if the stimulator needs 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 TransDiscat 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 TransDisca 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 m
Download Pdf Manuals
Related Search