Radiofrequency Probe & Radiofrequency
Contents
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5. Kimberly Clark Radiofrequency Probe amp Radiofrequency Generator Connector Cable Pain Management Instructions for Use Protective Tube y Handle Loo J RF Electrode i PC RF Probe Bend R RF Probe Plug In Relief Cable Fig 1 PMX XX YYC RF Generator Plug In RF Probe Connector cob clr RF Generator Connector Cable Fig 2 PMX BAY BAY RF Generator Plug In RF Probe Connector SE RF Generator Connector Cable PMX RAD BAY RF Generator Plug In RF Probe Connector RF Generator Connector Cable Fig 4 PMX BAY ORA RF Generator Plug In RF Probe Connector RF Generator Connector Cable Fig 5 PMX NEU BAY RF Generator Cable Plug In RF Probe Connector RF Generator Connector Cable Fig 6 PMX SAC BAY I Attention See Dispose of Ton Pyrogoniz LA N nstructions for Use gt lt Properly KiMBERLY CLARK Radiofrequency Probe amp Radiofrequency Generator Connector Cable Pain Management Rx Only Federal U S A law restricts this device to sale by or on the order of a physician Device Description The Kimperty Cark Radiofrequency RF Probes Fig 1 are individual electrodes that are used with a disposable radiofrequency RF cannula sold separately of the corresponding gauge and length The Kimeerty CLark Radiofrequency RF Generator Connector Cables PMX BAY BAY Fig 2 PMX RAD BAY Fig 3 PMX BAY ORA Fig 4 PMX NEU BAY Fig 5 and PMX SAC
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7. 1 4 pin female RF Probe Connector to connect to Probe 2 14 pin male RF Generator Plug In to connect to Generator PMX BAY ORA Fig 4 The Kimeerty CLark PMX BAY ORA connects the KiMBERIY CLARK RF Generator to the Smith amp Nephew Probe Model 4 Pin Intradiscal Catheter or 4 Pin Intradiscal Catheter XL Two different connectors 1 4 pin female RF Probe Connector to connect to Probe 2 14 pin male RF Generator Plug In to connect to Generator Note Cable should NOT be used with the Intradiscal decompression catheter if the generator in use is Generator Version 1 2 or lower Note fusing the PMG Version 2 0 ensure that the secondary thermocouple option is disabled Refer to Generator TD User Manual e Are used to connect an IDL probe model 902002 to the Kimperty CLark RF Generator Should NOT be used with the IDL decompression catheter if the generator in use is PMG Version 1 2 or lower e Have two different connectors 1 4 pin female RF Probe Connector to connect to Probe 2 14 pin male RF Generator Plug In to connect to Generator PMX NEU BAY Fig 5 The Kimeerty CLark PMX NEU BAY connects the KIMBERIY CLARK2 RF Probes to the Neurotherm Generator Two different connectors 1 4 pin female RF Probe Connector to connect to Probe 2 4 pin male metal RF Generator Plug In to connect to Generator PMX SAC BAY Fig 6 The Kimeerty CLark PMX SAC BAY connects the KIMBERIY CLARK
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14. Stimulate and lesion as necessary Refer to the RF Generator User s Manual for more information After the Procedure 1 Remove RF electrode of the probe from the cannula 2 Remove cannula from the patient 3 Disconnect the RF Probe from the RF Generator Connector Cable by pulling on the plug body Caution Prevent damage to your cable and probe When pulling the connectors apart be sure to pull on the plug and not the cable 4 Disconnect the RF Generator Connector Cable from the generator 5 Discard the cannula 6 Remove Disposable Indifferent dispersive Patch DIP electrode from patient and discard 7 Prepare the reusable probe and connector cable for cleaning and ster ilization Transfer the used Kimeerty CLark RF Probe and KIMBERIY CLARK RF Generator Connector Cable to a carrying surface and cover them with a wet cloth to ensure that blood and other contaminants do not dry on the surface Cleaning and Sterilization Instructions Danger The Kimerty CLark RF Probe and Kimeerty C ark RF Generator Connector Cable are shipped non sterile and must be cleaned and sterilized as per these Instructions for Use prior to each use Failure to properly clean and sterilize the device can cause patient injury and or the communica tion of infectious diseases from one patient to another Important The manufacturer recommends the user follow a quality control program for each sterilization cycle that meets or exceeds American Operating R
15. may be used Note For effective sterilization the protective tube MUST be removed during sterilization and placed next to the probe in the tray Warning Kimberly Clark has validated ONLY the previously mentioned cleaning and sterilization methods for the Kimserty CLark RF Probe and RF Generator Connector Cable No other cleaning and sterilization methods have been tested If any other type of cleaning or sterilization method is used on these products it is up to the user to verify sterility Failure to properly clean the device can lead to patient injury Troubleshooting The following table is provided to assist the user in diagnosing potential problems PROBLEM COMMENTS TROUBLESHOOTING No tem In order to measure Ensure that all connections perature temperature the are made measurement entire system must probe to connector cable in 77 77 sl al connector tableto mode evices must be in generator ood working order OR g 9 e generator to power outlet Check for an error message on the generator Visually inspect the probe or cable for damage Ensure that devices are dry and at room temperature If problem persists discontinue use Inaccurate erratic or sluggish temperature reading in treatment mode RF Probe The fit of the probe does not fit in the cannula is very into the RF precise Cannula In very rare situations the manufacturing of the probe and or cannula may prohib
16. not be liable for damages for loss of profits or claims of buyers 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 bpulep uoul 10 1IJ1qel JO suonellulii pue si vilepsip Suolsnpx SaULEM paur 894 SUO IPUOD pue swa 34 JO y b d p p tu p aq Ilpus Npod sly Jo asn s1 Nq ay 404 wep 84 0 s Prym J nq 0 yAe AjJaquuly Aq pjos spoob pay nads y Jo J nq 0113802 y 0 aq jeus saHewep 10 qlqeil 05 s e ALaquuly sabewep upns Aue 10 5 19 2 si nq sullpp 10 5 0 Jo sso 10 s betuep 104 1 q JOU Jjeys y1e Ajaquuly ey 5 iqpoup ds saXng y Koay ajqgeynba 10 1 uno Aue 10 flllqe l pnposd bilb u 42611 02 0 YeaIq AYUeLEM 10 yppeaaq p b lip Woy Hulse sabewep 10 ynsmej 10 wep Aue uj s beuleq 104 llqeri Jo uone lu1 sodind 10 sn P 10 SS U U 10 JI Iqe1UPuDJ ui 10 pal dwi 10 p ss idx JaYJaYM S RUBLEA P s pnpx pue sullppsip uep H quli p uol u ui snol A 1d se s IlJUPLIPA v hdi s p y
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18. 4 6 Dry the surface of the device on the outside with a clean dry towel Put the protective tube back onto the probe and place all parts back in the Sterilization and Storage Tray Sterilization All EXCEPT PMX SAC BAY The following sterilization methods have been validated for use with Kimperly CLark RF Probes and RF Generator Connector Cables Steam Sterilization e Gravity Displacement Steam Sterilization STERRAD Sterilization Sterilization PMX SAC BAY The following sterilization methods have been validated for use with Kimperty CLark PMX SAC BAY Generator Connector Cable Steam Sterilization e Gravity Displacement Steam Sterilization Steam Sterilization Prevaccum Wrapped 132 C 135 C 270 F 275 F for 3 4 min Unwrapped flash 132 C for 4 min Gravity Displacement Steam Sterilization Wrapped 132 C 135 C 270 F 275 F for 15 minutes Unwrapped Flash 132 C 135 C for 15 minutes STERRAD Sterilization Kimeerty CLark RF Probes and RF Generator Connector Cables may be sterilized with the following STERRAD systems STERRAD 1005 STERRAD 50 STERRAD 200 STERRAD NX STERRAD 100NX All instructions given in the corresponding STERRAD Sterilization System Users Guide must be followed Note The Kimserty Ciar RF Probe and RF Generator Connector Cable should NOT be sterilized within the autoclave case Any validated tray recommended for use with STERRAD
19. BAY Fig 6 respectively connect the Kimeerty Cark RF Probes to the RF Generator connect the Kimperty CLark RF Probes to the Valleylab RFG Series Generator connect the KIMBERIY CLARK RF Probes to the Neurotherm Generator connect the Kimperty CLark RF Generator formerly Baylis Pain Management Generator to the Smith amp Nephew Probe Model 4 Pin Intradiscal Catheter 4 Pin Intradiscal Catheter XL or 4 Pin Intradiscal Decompression Catheter connect the KimBerty CLark RF Probes to the STRYKER RF Generator cable or STRYKER RF Multi Gen Cable Indications For Use Kimperty CLark Radiofrequency Probe and Kimeerty CLark Radiofrequency Genera tor Connector Cable will be used in conjunction with a radiofrequency generator to create 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 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 lesion generator If the patient has a spinal cord deep brain or other stimulator contact the manufacturer to det
20. RF Probes to the STRYKER RF Generator or STRYKER RF Multi Gen e Two different connectors 1 4 pin female RF Probe Connector to connect to Probe 2 12 pin male metal RF Generator Plug In to connect to Generator cable Storage Instructions KimBerLy CLarK RF Generator Connector Cables should be stored in a cool dry place Store the RF Generator Connector Cables in the Sterilization and Storage Tray provided to reduce the risk of damage due to storage Autoclave Case is Shipped non sterile Should be used at all times to store the Kimberiy CLark Probe and KIMBERIY CLARK RF Generator Connector Cable Steam sterilizable and should be used to hold the devices while they are being sterilized NOT to be used with STERRAD Inspection Prior to Use Perform the following checks before the patient is presented for the procedure These steps will allow you to verify that the equipment you will use is in proper working order Do these tests in a sterile environment e Sterility Check The RF Probes and RF Generator Connector Cables are shipped non sterile They must be sterilized prior to each use e Visual Inspection Ensure RF Probes and RF Generator Connector Cables have no visible damage such as discoloration cracks label fading cable splice or kinks Do NOT use damaged or defective equipment e Residual Moisture Ensure the RF Probes and RF Generator Connector Cables are dry Residual mo
21. e Discontinue use if inaccurate erratic or sluggish temperature readings are observed Use of damaged equipment may cause patient injury e Do not modify Kimserty Ciark Equipment Any modifications may compromise the safety and efficacy of the device When an RF Generator is activated the conducted and radiated elec trical 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 han dling of the RF Probe particularly when operating the device e 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 Kimperty CLark RF Probes and RF Generator Connector Cables before thoroughly reading the Instructions for Use and the Users Manual for the RF Generator The Kimperty CLark RF Probes and RF Generator Connector Cables should be used by physicians familiar with RF lesion techniques e 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 adjust treament parameters before checking for obvious defects or misapplication In order to prevent the risk of ignition make sure that flammable material is not
22. ermine if the stimulator needs to be in the bipolar stimula tion 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 treatment should be performed under local anesthesia Systemic infection or local infection in area of the procedure Blood coagulation disorders or anticoagulant use Warnings Kimserty Ciark RF Probes and RF Generator Connector Cables are shipped non sterile and must be cleaned and sterilized prior to use as instructed in the Instructions for Use The Kimeerty Cark RF Probes and RF Generator Connector Cables are reusable devices Failure to properly clean and sterilize the device can cause patient injury and or the communication of infectious diseases from one patient to another Kimserty CLark RF Probes and RF Generator Connector Cables must be used with the correct connector cable Attempts to use it with other RF Generator Connector Cables can result in electrocu tion of the patient or operator e Laboratory staff and patients can undergo significant x ray expo sure during RF 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
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24. isture can cause malfunctions Equipment Required RF lesion procedures should be performed in a specialized clinical setting with fluoroscopic equipment The RF equipment required for the procedure is as follows e Disposable RF Cannula RE Probe and corresponding RF Generator Connector Cable RE Generator e Disposable Indifferent dispersive Patch DIP electrode meeting ANSI AAMI standard HF 18 requirements for electrosurgical electrodes Instructions for Use 1 Assemble all required equipment for the intended procedure and posi tion the patient as necessary 2 Attach the Disposable Indifferent dispersive Patch DIP electrode Read and follow the manufacturer s Instructions for Use of the DIP electrode to determine proper placement Always use DIP electrodes that meet or exceed ANSI AAMI HF 18 requirements 3 Connect the appropriate connector cable to the connector cable connec tion on the RF generator Maintain access to the RF Probe Connector on the connector cable in order to facilitate easy attachment of the probe 4 With the stylet in the cannula insert the cannula into the patient using fluoroscopic guidance to place the active tip at the desired lesion location 5 Once the cannula is properly placed carefully remove the stylet from the cannula and insert the pre sized RF Electrode down the shaft of the cannula 6 Attach the probe to the connector cable via the Probe Plug In and RF Probe Connector 7
25. it the correct fit Ensure that the stylet has been removed from the cannula Ensure that the RF Electrode is completely smooth and clean Check the gauge of the cannula and ensure that the correctly sized probe is in use Try another cannula of the same size RF Probe Connector does not fit in RF Probe Plug In Check that the connector s keys are lined up in the proper orientation Ensure that the connectors are clean and unobstructed Each of the connec tors is designed to connect in a specific way for safety rea sons If the connector keys are out of line the connectors won t fit together RF Electrode Due to the small di Breaks or ameter shaft the RF Kinks Electrode portion of the Kimperty CLark RF Probe can withstand very little damage due to handling Discard Immediately Customer Service and Product Return Information If you have any problems with or questions about this KIMBERIY 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 Notes In order to return products under limited warranty you must have a return authorization number before shipping the products back to Kimberly Clark Limited Warranty Kimberly Clark warrants that these products are free from defects in original w
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28. oom Nurses AORN Standards Recommended Practices amp Guidelines 2000 This program includes but is not limited to recording e Type of sterilizer and cycle used e Lot control number e load contents e Exposure time and temperature if not provided by a recording chart e Operators name e Results of sterilization process monitoring i e chemical mechanical biological Cleaning and Decontamination 1 Ensure that blood and other contaminants do not dry on the Kimperty CLark RF Probe and the Kimeerty CLark RF Generator Connector Cable 2 Remove the protective tube from the probe and follow the Instructions below for each piece separately 3 Rinse all parts with deionized water until colorless run off water occurs Once the water runs clear soak the parts except for the connectors in deionized water at 22 C 48 C for 1 minute Remove the probe and components from the water and scrub them with a soft bristle brush until they are visually clean Note Do not let the connectors soak Wipe connectors as necessary until they are visually clean 4 Soak the probe and components except connectors in an enzymatic cleaning solution for 20 minutes Ensure that the temperature of the solution is below 55 C Scrub again with a soft bristle brush and rinse thoroughly using deionized water until all traces of detergent residue are removed 5 Visually inspect the parts again for debris if any is present repeat steps 3 and
29. orkmanship 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 lark5 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 Probe 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 as previously mentioned Kimberly Clark disclaims and excludes all warranties whether expressed or implied of merchantability or fitness for a particular use or 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 legal or equitable theory the buyer specifically agrees that Kimberly Clark shall
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31. present in the room during RF power application It is the physician s responsibility to determine assess and communicate to each individual patient all foreseeable risks of the RF lesion procedure 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 Kimeerty CLark RF Probes should be used by physicians familiar with RF lesion techniques KiMBER Y CLARK RF Probe Fig 1 The Kimperty CLark RF Probes PMP are individual electrodes that are used with disposable RF cannula sold separately of the corresponding gauge and length e Available with straight and curved cannulae Model number indicates cannula information Model Number Probe XX YYC where XX indicates gauge of cannula associated with the probe YY indicates length of cannula associated with the probe C if present indicates that cannula is curved Note Please contact Kimberly Clark for a list of all model numbers and sizes RF Probes are shipped non sterile and must be sterilized as per Instructions for Use prior to use Are supplied non pyrogenic Are supplied with the following additional parts e protective tubing to prevent bending or kinking of the RF Electrode during handling e Black 4 pin male connector Probe Plug In to connect the Kimperty CLark RF Probe to the RF Gene
32. rator Connector Cable Color coded bend relief which corresponds to the gauge of the cannula they should be used with White 16G Pink 18G Yellow 20G Green 21G Black 22G e Black probe cable for use with straight cannula and a white probe cable for use with curved cannula Storage Instructions KIMBERIY CLARK RF Probes should be stored in a cool dry place Store the RF Probes in the Sterilization and Storage Tray provided to reduce the risk of damage due to storage Special Handling Instructions The Kimberty CLark RF Probe is delicate due to its small diameter RF electrode Do not bend kink or stress the RF electrode Do not crush or splice the probe cable Doing so could damage the temperature sensing mechanism in the device and lead to improper temperature measurement KiMBERIY CLARK RF Generator Connector Cables Five models PMX BAY BAY PMX RAD BAY PMX BAY ORA PMX NEU BAY PMX SAC BAY Shipped non sterile and must be sterilized as per Users Manual prior to first use PMX BAY BAY Fig 2 The Kimeerty CLark PMX BAY BAY connects the Kimperty CLark RF Probe to the Generator PMG Two different connectors 1 4 pin female RF Probe Connector to connect to Probe 2 14 pin male RF Generator Plug In to connect to Generator PMX RAD BAY Fig 3 The Kimeerty CLark PMX RAD BAY connects the Kimperty CLark RF Probe PMP to a Valleylab RFG Series Generator e Two different connectors
33. ud ay OJUO Peq qm 9AI I9 0Id t Ng 19400 ue p e YUM apis no y UO adIAap v JO DENS ay IG 9 y pue sd s e d 1 1u s ud si Aue JI suq p 10 uree sed y p dsul JeNSIA ae np s JUdHJa ap JO s 2e1 hun 1972M p zl ol p bulsn Ajyhnosoyy suli pue usniq 1SIIqQ 110 e YM urepe qnD Mojaq 51 uonn os y 40 lmibl d l y zey Insu3 sayNUIW QZ 10J 401 105 Bulue p hpu l z UP ul S10 2 UU02 d x s Ju uodui02 pue qold By Up p Ajjensia Ady jun 1pss 2 u se si0 2 uuo 3D0S 10 23UU02 AY 19 JOU OG 9 ON ue p AjjensiA v un usniq hsliq 105 L YIM Wal QNS pue Ja eM ay W014 sJu uoduuo pue ay BAOWAY NULU 10 8p Z7Z 18 p Zluol p u S1012 UU02 y 10 1d X sed Y 5 IL SUNI Y DUQ 511220 1972M JJO UNJ S9 10 09 llun 19354 p Zluo0l p YIM syed asuly Ajayesedas adaid pp 104 M l q SUOI INIYSU BY A0 0J pue qo1d y qn aAI Da 01d BY Z 9106 10p UU0 44 HUVT ATUIAWIY Y PUL qolq JOUNIN 4Y uV1T AT39WIJ y UO ap JOU op SJURUILUE UO 19470 pue poojq eyz nsuJ uoizeurwezuo q pue Bulue 1e2160 01q polubup ui ewy 3 1 bullo luoti 5592010 101921 1915 JO sj ns 5 Wey Hulpsorad e Aq 30u Jl
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