SInergy™ User Guide
Contents
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3. The follovving section outlines the procedure for setting up the Pain Management Sinergy System We have provided two set up guides e Quick Start Equipment Set Up designed for users who have previously handled the equipment Detailed Equipment Set Up designed for users who are using the system for the first time Equipment Set Up Diagram The Pain Management Slneroy System consists of Reusable Equipment 1 Pain Management Generator V2 2A or higher 2 Pain Management Pump Unit 3 Pump Connecting Cable not shown 4 Pain Management Cooled RF Connector Cable Disposable Kit 5 One Pain Management Tube Kit 6 One Pain Management Slnergy Probe 7 Two Pain Management Slnergy Introducers 8 Two Pain Management Epsilon Rulers not shown Quick Start Equipment Set Up Connect the Generator to the Pump Unit Plug in the Generator and turn it on Insert one Pain Management Tube Kit into the Pain Management Pump Unit Fill the burette with sterile water Connect the Cooled RF Connecting Cable to the Generator Place the introducer and probe in the patient Connect probes to Pain Management Tube Kit Connect the probe to the Cooled RF Connecting Cable VOSS oN PM1013 Rev 09 08 Page 11 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Detailed Equipment Set Up 1 Connect the Generator to the Pa
4. Guidelines 6 Place the Dispersive Electrode on the patient e Place the Dispersive Electrode on the patient according to the Instructions for Use provided with the kit 7 Connect probes to Pain Management Tube Kits e Pass the tubing and electrical connections on the probe out of the sterile field Remove the caps from the two luer locks on the Slnergy Probe and the Tube Kit Connect the luer locks snugly Maintain sterility of the tubing s inner pathway so in case water is accidentally spilled in the sterile field sterility will not be compromised Luer Lock Cap PM1013 Rev 09 08 Page 15 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 8 Connect the probes to the Cooled RF Connecting Cable Connect the male connectors on the Slnergy Probes to the female connectors on the Cooled RF Connecting Cable e Connect the Cooled RF Connecting Cable to the generator 9 Connect the Dispersive Electrode to the Generator Now the equipment set up is complete PM1013 Rev 09 08 Page 16 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 8 Procedure Guidelines Overview This section describes the positioning of the introducers and probe within the patient In this section you will learn e
5. experiments were designed to map temperatures in the tissue and in the surrounding neural structures to ensure that heat was applied in a manner suitable for both efficacy and safety during treatment For practical use set the Advanced Settings on the generator as follows Ramp Rate 80 C min Post Treatment Cooling Disable Number of Probes 1 Power Limit 12 Watts PM1013 Rev 09 08 Page 40 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 10 Generator Graphs During Treatment Overvievv This section shows images of generator screens to explain what a typical procedure looks like compared to an abnormal procedure In this section you will learn e Appearance of a typical procedure graph e Appearance of an abnormal procedure graph The figures in this section represent screens of a Baylis Pain Management Generator Model PMG 115 TD and PMG 230 TD V2 2A Refer to the generator s user manual for complete details The graph on the generator shows the temperature COOLED RF TEMP in yellow and the power POVVER in magenta An ideal procedure graph as shown below has fairly smooth lines with the COOLED RF TEMP rising steadily until the SET TEMPERATURE dashed yellow line is reached The POWER will increase until the COOLED RF TEMP reaches SET TEMPERATURE Following this the POWER may p
6. of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 9 Lesion Parameters Overvievv This section describes the parameters used to control the heating profile during the procedure n this section you will learn e VVhat the modifiable parameters are e How the parameters affect the heating e Suggested parameters to use Parameters used to create heating profile The parameters available to control the heating profile are Ramp Rate Set Temperature Time 70 Set Temperature La 60 4 9 Ramp Rate C minute Duration a minutes Time min There is a temperature sensor at the tip of the Sinergy Probe The generator will monitor this temperature sensor and automatically deliver the required power to raise the temperature of the target tissue The shape of the heating profile is determined by the parameters Ramp Rate Set Temperature and Time At the beginning of the procedure the temperature is lower than body temperature because the pumps are running and cooling has begun The probe temperature will increase at the Ramp Rate PM1013 Rev 09 08 Page 38 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued until it reach
7. surface of the skin Consider the tip of the marker needle as representing the center of a clock face Rotate the Epsilon ruler around this point such that the upper spoke is marking a location equivalent to 2 30 for right sided treatment or 9 30 for left sided treatment IMPORTANT NOTE Similar to other fluoroscopic measurement techniques the Epsilon ruler will experience some degree of parallax error This is because the sacrum and the Epsilon are at different depths with respect to the image intensifier To minimize y parallax error experienced as distortion of the shape of the ruler when it is tilted both the Epsilon ruler and the patient s sacrum should be perpendicular to the beam of the emitter during placement In other words the Epsilon should be flat on the patient s skin and the image should be A P PM1013 Rev 09 08 Page 24 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 5 The first target location with the Cooled RF probe is 7 to 10mm lateral and slightly inferior to the S1 finder needle On the clock face this corresponds to a 4 o clock position 8 o clock for left sided treatment With the use of the Epsilon ruler as a guide direct the introducer perpendicularly down the beam until the stylet has made firm contact with the dorsal sacral surface Note that the ligame
8. the screen e The error fault event text message displayed including possible cause error fault code and recoverable non recoverable indications regarding Cooled RF Mode are listed in Table 1 NOTE For recoverable faults the error code is displayed for approximately 10 seconds the Generator will automatically transition back to the previous READY state PM1013 Rev 09 08 Page 50 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Table 1 Cooled Error Fault code interpretation LCD Text Message LCD Text Message A Measured Temperature Exceeds Setpoint Possible high impedance or desiccated tissue at probe tip A Measured Power Exceeds Setpoint Please check all probe and cable connections Possible intermittent cable or poor tissue contact A Excessive RF Current Measured Possible short between electrodes or defective probe or cable A Excessive RF Voltage Measured Possible intermittent cable connection or loss of tissue contact A Excessive RF Power Measured Possible intermittent tissue contact Possible defective probe s or cable s A High Impedance Detected Check probe cable and dispersive return electrode connections Possible poor tissue contact Probe or cable may be defective A Unrecognized Probe Type See User Manual for a list of valid probes Please note e
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10. volume spherical lesions When these lesions are positioned appropriately the inherent variability of nerve target location can be overcome in a practical and efficient manner Temperature Control Temperature sensors at the electrode tips allow the RF generator to control the power delivery and the rate of internal electrode cooling In this manner lesion shape and size will remain consistent This is particularly important in an area of the anatomy that contains multiple tissue types near the target structure Note that the temperatures at the electrode tips are reflective of the surface of the cooled electrodes and not the maximum lesion temperature Spherical Lesions The spherical shape of the lesion allows perpendicular oblique or parallel approaches towards the target structure The distally projecting portion of the lesion will form around ridges and within crevices on irregularly shaped surfaces Safe amp Easy Placement Placement of the Sinergy probes is straight forward and results in minimal disturbance to the overlying soft tissue Introducers and electrodes are directed at the target using a down the beam perpendicular approach To reposition towards adjacent targets the introducer is retracted slightly and pivoted about the skin rather than creating additional skin punctures Summary of System Benefits The Sinergy System creates reproducible large volume lesions by utilizing e Temperature controlled radiofreque
11. 30 Monitor the patient s response during lesioning for non concordant pain in the groin anterior thigh lower leg or foot The lesion can be stopped at any time by pressing the ON OFF button on the lower right corner of the pain generator PM1013 Rev 09 08 Page 36 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 21 Optionally perform a second lesion at the base of the superior articular process of the sacrum 6 8mm inferior to the first lesion location Post Procedure Care Discharge Instructions on the day of the procedure Do not drive or operate machinery Do not engage in any strenuous activity Do not soak in the bathtub but a shower is okay Eat a regular diet You may remove bandages the following day You may use an ice pack today and warm moist heat tomorrow if you experience discomfort when the local anesthetic wears off e f you experience fever chills or severe pain at accompanied by swelling and redness at the injection site contact your treating physician e f you experience shortness of breath or chest pains go to the nearest emergency room Activity Guidelines e Resume normal activities as tolerated the day after the procedure e Avoid excessive activity lifting or other forms of increased physical activity for 1 3 days following the procedure PM1013 Rev 09 08 Page 37
12. 90 6 9 Organ LW Electrophysiologic principles of radiofrequency lesion making Appl Neurophysiol 1976 39 69 76 10 Saberski L Fitzgerald J Ahmad M Cryoneurolysis and Radiofrequency Lesioning In Raj P ed Practical Management of Pain Third ed Mosby 2000 753 67 11 Watanabe 1 Masaki R Min N et al Cooled tip ablation results in increased radiofrequency power delivery and lesion size in the canine heart importance of catheter tip temperature monitoring for prevention of popping and impedance rise J Interv Card Electrophysiol 2002 6 9 16 12 Wittkampf FH Hauer RN Robles de Medina EO Radiofrequency ablation with a cooled porus electrode catheter abstract J Am Coll Cardiol 1998 11 13 Wong WS VanderBrink BA Riley RE et al Effect of saline irrigation flow rate on temperature profile during cooled radiofrequency ablation J Interv Card Electrophysiol 2000 4 321 6 14 Yin W Willard F Carreiro J et al Sensory stimulation guided sacroiliac joint radiofrequency neurotomy technique based on neuroanatomy of the dorsal sacral plexus Spine 2003 28 2419 25 PM1013 Rev 09 08 Page 56 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued
13. Baylis Medical Company Inc Patents pending and or issued Trouble Shooting Flovv Chart Legend Error Persists n b Errors 101 103 and 104 mb Error Clears gt See additional text Error 101 Error 104 Loose or Check all improper connections connections Loose connection Ensure pump PMG connection cable is secure Ensure pump lids are closed Ensure tubing Tubing is correctly incorrectly placed within placed within the pump pump head head Pump lids vvere open Tube kit tube incorrectly connected to connecte correctly to probe the probe Damaged Cooled RF E Connector nsure vvater Cable Occluded is flowing tube kit through the tube kit and float ball is floating Swap Cooled RF Connector Cable Re prime while squeezing upper and lower jaw of pump head SI Damaged a Probe Internal error requires repair Call Clinical Support PM1013 Rev 09 08 Page 54 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Trouble Shooting Flovv Chart Legend gt Error Persists Errors 106 108 123 125 ma Error Clears gt See additional Errors 108 123 125 text 7 Ensure sterile water is gt 7 17 C and lt 34 C temperature Improper connections
14. Check all connections Damaged Cable Swap Slineroy Connecting Cable Swap SInergy Probe Damaged Probe Internal error requires repair Call Clinical Support PM1013 Rev 09 08 Page 55 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 12 References 1 Aranovv S The use of radiofrequency power in making lesions in the brain J Neurosurg 1960 17 431 8 2 Borggrefe M Hindricks G Haverkamp VV et al Catheter ablation using radiofrequency energy Clin Cardiol 1990 13 127 31 3 Dadd JS Ryan TP Platt R Tissue impedance as a function of temperature and time Biomed Sci Instrum 1996 32 205 14 4 Gabriel C Gabriel S Corthout E The dielectric properties of biological tissues 1 Literature surveys Phys Med Biol 1996 41 2231 49 5 Haemmerich D Chachati L Wright AS et al Hepatic radiofrequency ablation with internally cooled probes effect of coolant temperature on lesion size EEE Trans Biomed Eng 2003 50 493 500 6 Lorentzen T A cooled needle electrode for radiofrequency tissue ablation thermodynamic aspects of improved performance compared with conventional needle design Acad Radiol 1996 3 556 63 f Noe CE Racz GB Radiofrequency In Raj P ed Pain Medicine A Comprehensive Review First ed Mosby 1996 8 O Connor JL Bloom DA William T Bovie and electrosurgery Surgery 1996 119 3
15. L5 dorsal root These nerves are known to be responsible for sacroiliac joint complex mediated pain In this procedure a Pain Management Sinergy Introducer is placed at a point between the posterior sacral foramen and the sacroiliac joint A Pain Management Slneroy Probe is inserted through the introducer and into the tissue superficial to the posterior surface of the sacrum Radiofrequency RF energy is delivered from and concentrated around the electrode The electrode is internally cooled with circulating water RF energy heats the tissue while circulating water moderates the temperature in close proximity to the electrode This combination creates large volume lesions without excessive heating at the electrode Successive lesions are created by repositioning the introducer and electrode in a step wise manner until all lateral branches between the sacral foramina and the sacroiliac joint have been disrupted For a list of equipment related to the Pain Management SlInergy System see Section 5 A physician using this equipment must be familiar with lumbar sacral spine anatomy image guided spine procedures and sacroiliac joint injection techniques Important Message This guide does not replace the information in the Instructions for Use provided with the components of the Pain Management Slnergy System The Instructions for Use includes important information such as vvarnings precautions contraindications and trouble shooting The Instructio
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18. PAIN MANAGEMENT N x K N Sinergy System USER GU DE For effective denervation in the treatment of chronic sacroiliac joint pain September 2008 PM1013 Rev 09 08 1 Table of Contents E d 2 2 RLO UCURua DL O Do 2 3 Physics of the Pain Management Slnergy System 4 Benefits of the Pain Management Slneroy System 7 5 Technical Description of the Equipment 8 Oy Rada aa 10 fe Setup IASWUCTIONS 11 Oe EP OCEGLU UIC SINS S a an 17 Ox eson Parame 38 10 Generator Graphs During Treatment 41 11 PT POUTOIS SMO a B dr 45 12 CTEChCES 46 2 Introduction The Pain Management Slnergy System in combination with the Baylis Pain Management Generator PMG TD is indicated for creating RF lesions in nervous tissue to treat patients with sacroiliac joint complex mediated pain The procedure is known as sacroiliac joint radiofrequency neurotomy and ablates the afferent nociceptive nerves Target structures include the lateral branches of the S1 though S3 dorsal roots and the dorsal ramus of the
19. The general safety guidelines for placement e Brief lumbar sacral anatomy with fluoroscopic and photographic images e Step by step placement technique General Safety Guidelines For safe and effective tissue heating and safe anatomical access abide by the following guidelines For L5 dorsal ramus neurotomy the electrode should be directed at the dorsal surface of the notch between the sacral ala and the superior articular process of the sacrum On a lateral fluoroscopic view the introducer should be no further ventral than the anterior posterior midline of the superior articular process SAP Placement more superior ventral to the target point brings the electrode closer to the segmental nerve root and increases the risk of inadvertent heating of this structure For 51 S3 lateral branch neurotomy the electrode should be placed such that the active tip is at least 7 mm from the edge of nearest posterior sacral foramina This electrode placement will ensure that there is no heating at the sacral canal Electrode depth should be confirmed with lateral fluoroscopy prior to lesion creation This will verify that the electrode is located superficial to the sacral surface and confirm that it has not slipped into the nearest posterior foramen e For all targets the introducer should be directed towards the target site until the tip is in contact with bone When the stylet is removed and the electrode is inserted there will be a 2 mm ga
20. This is demonstrated not only between specimens but also from side to side and from level to level There exists no correlation between nerve location and the bony landmarks identifiable under fluoroscopy This variability presents a challenge for clinicians seeking to treat sacroiliac joint syndrome PM1013 Rev 09 08 Page 19 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Procedure Preparation The patient should be N P O prior to the procedure Bovvel prep is encouraged for enhanced imaging quality but is optional based on physician preference Prophylactic antibiotics can be administered prior to the procedure based on physician preference Place the patient in the prone position on the table The patient must be monitored properly throughout the procedure using verbal communication as well as equipment to measure heart rate blood oxygen level and blood pressure As with any minimally invasive technique adhere to sterile procedural practices Prepare the site with sterile draping to maintain sterility of the lower lumbar and sacral area The procedure is conducted with the aid of fluoroscopic guidance Precautions should be taken to minimize exposure to radiation Ensure the patient is comfortable and the appropriate pharmacological pain therapy has been administered This may constitute intravenous sedatio
21. ademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 4 Fill the burette vvith sterile vvater Fill the burette to the 70 mL mark with room temperature sterile water by a injecting through the port in the lid or b removing the lid and pouring the sterile water into the burette a Inject sterile water through the port in the lid e Remove the cap of the burette e Using a sterile syringe fill the burette with 70 ml of sterile water at room temperature b Remove the lid and pour sterile water into the burette e Open the lid by pressing in and up with your thumbs around one of the three petals e Observe proper sterile handling technique while filling the burette do not place the lid of the burette down on a non sterile surface e The fill lines on the burette represent 7OmL and 80mL respectively e After filling to between the lines snap the lid back into place on the burette e Note that not all burettes have removable lids In this case fill the burette by injecting water through the port in the lid Upper 80mL and Lower 7OmL Fill Lines PM1013 Rev 09 08 Page 14 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 5 Place the introducer and probe in the patient Prepare the patient and place the Sinergy Introducer and Probe See Section 8 for Placement
22. along the inside lateral aspect of each S1 S2 and S3 sacral foramina until it has entered the posterior aspect of the sacral canal The purpose of this finder needle is to act as a reference point for the placement of the introducer and the probe in the absence of reliable bony landmarks PM1013 Rev 09 08 Page 22 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 3 t is important to confirm that the finder needles are in the sacral foramina by rotating to a lateral fluoroscopic view The tip of the needle should be visible in the sacral canal The finder needles are then withdrawn until the tip of each needle is marking the posterior aspect or opening of the sacral canal Finder Needles PM1013 Rev 09 08 Page 23 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 4 Obtain an A P fluoroscopic image Place an Epsilon ruler on the skin near the insertion site such that the central spoke is aligned with the lateral border of the S1 foramen as marked by the tip of the finder needle The Epsilon ruler is a small stainless steel ruler which projects linear distance onto the sacrum and provides a reference for appropriate lesion spacing Surgical tape can be used to help secure the Epsilon to the
23. ar during a Slnergy procedure Trouble Shooting Pain Management SInergy System Components In addition to the information contained within this document each Sinergy Kit has a troubleshooting table in its Instructions for Use to assist the user in diagnosing potential problems PM1013 Rev 09 08 Page 45 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued p nss Jo pue sjusjeg Ou Auedwog jeopan sieg Jo 5 61 10 pue syewape ase uojsdg pue ADIUS 002 XU AUedwod jeaipan sieg 80 60 ELOLWd 9G JO bi qn v pueosiq pil y Hulaowa uey pij v Ul yod v 9 1091 YOO lini e Ul zey Huiqn yy eqn JO 4011995 y zlinss ld e Sulsn syeoli UN 29 BY u sool 0 BY 5 dn 18S zu wd nb v ul d s s s pino qn p deus 7 v olul qni 94 Jo Y JO WO 0g y wou Buiwoo Sulqm v soejd pue dund y JO y u do in i sde yoo PyYM v YOO jew uO pue BuO sey yy qn pue insuq pobewep jou ase suid ou ey pue suid Jo
24. cates the tissue temperature local to the electrode This decreasing gradient of PM1013 Rev 09 08 Page 4 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued current density limits the size of the heat lesion that can be produced VVith a constant power a heat lesion will only grow to a limited size because the amount of heat created will come to equilibrium with the heat removed by the surrounding tissue and blood flow Figure 2 Current density represented by arrows around an electrode represented by the circle Note how the tail ends of the arrows are more concentrated at the electrode and less dense as the arrows radiate away from the electrode A way to increase the volume of tissue heated using RF is to increase the power However increasing power also has its limitations AS power increases so does the temperature of the tissue in close proximity to the electrode Exceeding 95 C may cause cavitations tissue charring and uncontrolled lesion formation It has been demonstrated that tissue impedance the measurement of tissue resistance to alternating current decreases as the temperature increases up to 60 to 70 C further increase in temperature however leads to a rapid increase in tissue impedance As tissue impedance increases at high temperatures the further flow of current becomes more difficult and harder to
25. control Internally Cooled RF Systems Another means of increasing the volume of the lesion is by using internally cooled RF electrodes This technique was first proposed by Wittkampf in 19881 The hollow lumens of internally water cooled probes permit continuous cooling of the electrode with a fluid Internally cooled RF electrodes act as heat sinks that remove heat from tissue adjacent to the electrode Consequently time duration or power deposition can be increased during the procedure without causing high impedance and tissue charring around the electrodes As a result internally cooled electrodes can produce much larger lesions compared to non cooled electrodes Furthermore the tissue in proximity to the electrode does not need to be as hot in order to reach target temperatures at greater distances away from the electrode Figure 3 The water used for circulation in cooled RF lesions need only be room temperature When used for cooled RF water temperatures of 5 C have been shown to not significantly affect lesion size in ex vivo hepatic ablations compared to water temperatures of 25 C However increasing flow rate of the coolant has been demonstrated to significantly affect lesion size PM1013 Rev 09 08 Page 5 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued n summary by cooling the tissue adiacen
26. dwu jewou 16 1 e Aq p lupdulo22E q Ajay SIU uOq JO nssn SANOSUUOD SU D UIYJIM p uonisod s y 1 AY uses q ACW 9 9 s yids JO suonepilloso abe AA aqojd y uonisod l pue uoyng HO UO nd no v Ssseid inp oold y dois Adu 1 lEsun Ue o JOU y UL LUO o bu Adoosolonil v Y29490 SulAoul ned 10 y o np og Aew sul pouu 1u unp n ul u s q yiu s yids JO 54 12050 jews sn nunuoosi p 51515 ye pue p zey 9 JO ajqed 10 y dsul 8016 Sunoous iqno n JO eyo moj 0 Z pue 9014 pnfoul s po JOE 01850 v UO ess w Ue suonoy Bunoous lqnolL 80 60 ELOLWd OM qolc A5s uls Jaye s JuUsUISHeUReW uled JOU S8OP UO S one aonad lqissod Pain Management Generator Error Fault Codes for Cooled RF Mode lf an error fault condition should occur a pop up message will display an error fault code in the center of
27. ebrae e Greater than 80 pain relief from two separate intra articular blocks with no more than 2cc of injectate per block It is recommended to use higher concentration anesthetic such as 0 75 bupivacaine or 4 lidocaine for a more effective block e Chronic axial pain lasting for longer than six months e Age greater than 18 years e Failed to achieve adequate improvement with comprehensive non operative treatments including but not limited to activity alteration non steroidal anti inflammatory physical and or manual therapy and fluoroscopically guided steroid injections in and around the area of pathology All other possible sources of low back pain have been ruled out including but not limited to the intervertebral discs the zygapophyseal joints the hip joint symptomatic spondylolisthesis and other regional soft tissue structures Candidates for the Sacroiliac Joint Neurotomy procedure will be excluded if they meet any of the following criteria Pregnancy Systematic infection or localized infection at the anticipated introducer entry site History of coagulopathy or unexplained bleeding Irreversible psychological barriers to recovery Active radicular pain radiculopathy Immunosuppression PM1013 Rev 09 08 Page 10 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 7 Setup nstructions Overvievv
28. ed 500 ohms Impedance values exceeding 500 ohms may indicate that the probe is positioned in tissue not suitable for lesioning or that the probe is not fully seated in the hub of the introducer The position of the probe is secured by sliding the green depth stopper down to the surface of the skin PM1013 Rev 09 08 Page 27 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 8 Create the first lesion according the parameters outlined in Lesion Parameters Section 9 of this document Suggested parameters include Set Temperature 60 C Time 2 30 Monitor the patient s response during lesioning for non concordant pain in the groin anterior thigh lower leg or foot The lesion can be stopped at any time by depressing the ON OFF button on the lower right corner of the pain generator Isotherm Celcius PM1013 Rev 09 08 Page 28 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 10 After the first lesion is complete remove the probe from the introducer and replace it vvith the stylet This is important as the probe is not designed to penetrate tough connective tissue Directing the probe through connective tissue may render it inoperative The second target site is 7 10 mm superior and lat
29. ent to flow through it and is based on the availability of loose electrons in the material Resistance is the opposite of conductance Copper wire for instance has high conductance and is a good conductor while rubber has low conductance and is a very poor conductor Since rubber is a poor conductor this means that it is a good resistor In a resistor as current passes through the material energy is used The harder it is to pass current through a material due to lower conductance the more energy is used The energy that is used does not disappear but is converted to a different form of energy often in the form of heat The conversion of electrical energy to thermal energy by passing current through a material with resistance is called resistive heating A good example of resistive heating is an electric toaster The metal filament in the toaster is PM1013 Rev 09 08 Page 3 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued made of nickel and chromium which has an ideal resistance to convert electricity to heat Biological tissue is not a very good conductor when using direct current Resistive heat can be generated but the flow of current cannot be controlled easily and it can damage the cells Using direct current to heat tissue may produce unpredictable tissue temperatures and irregular shaped lesions Excessive temperatur
30. eral to the tip of the S1 finder needle On the clock face this corresponds to a 2 30 position 9 30 position on the left side and should be marked by the upper spoke of the Epsilon ruler The introducer and stylet are then redirected tovvards the second target site by withdrawing slightly and pivoting about the skin In this manner the original skin puncture can be used as a pivot point for the second and third targets Confirm electrode placement and create a lesion using the same procedures described previously S1 9 30 PM1013 Rev 09 08 Page 29 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 11 Remove the probe and replace the stylet in the introducer The third target site is 7 10 mm inferior and lateral to the finder needle On the clock face this corresponds to a 5 30 position 6 30 position on the left side and should be marked by the lower spoke of the Epsilon ruler Once again the original skin puncture can be used as a pivot point Withdraw the introducer slightly and direct it towards the target Confirm electrode placement and create a lesion using the same procedures described previously PM1013 Rev 09 08 Page 30 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or i
31. es the Set Temperature The temperature will remain at the Set Temperature until the Time is complete Effect of Parameters Ramp Rate is the rate of increase in temperature per minute as measured by the probe s temperature sensor A slower Ramp Rate results in better control of heating larger volumes of heated tissue and more consistent temperature profile A faster Ramp Rate results in shorter procedure time In conventional non cooled RF procedures such as a z joint rhizotomy the ramp rate is usually about 15 seconds The optimum ramp rate for the Slnergy System is only slight longer lasting 25 seconds t must be understood that this time has been optimized to balance procedural speed and lesion consistency Ramp Rate can only be changed in the Advanced Settings of the generator Set Temperature is the desired temperature of the probe s electrode surface The temperature will increase at the Ramp Rate until it reaches the Set Temperature which is then maintained Due to the cooling of the electrodes the Set Temperature will be 10 15 Celsius lower than the tissue a few millimeters from the electrode The level of the Set Temperature in combination with the Ramp Rate and Time will affect the temperature throughout the tissue Set Temperature can be changed at any time before or during the RF delivery Time is the duration of radiofrequency energy delivery including the temperature ramp up and plateau A longer Time will allow a grea
32. es would lead to burning of tissue gas formation and uncontrolled destruction of tissue lonic Heating with AC Another way electrical energy is converted to heat in tissue is by ionic heating To overcome the drawback of direct current use of alternating current for medical applications was pioneered by Cushing and Bovie in the 1920s originally for hemostasis Later in the 1950s Aranow and Cosman deployed alternating current for creating neural lesions Alternating current conducts through tissue with less resistance and more control than direct current The greater the alternating current frequency the greater the conductance Alternating current causes the charged molecules or ions in the tissue to follow the directional variation of the alternating current resulting in molecular vibration The molecular vibration produces heat due to frictional forces This effect is called ionic heating The body is a complex system that uses electric current for a wide range of functions from regulating a heart beat to sending the sense of touch from a finger to the brain If alternating current is applied to the body using frequencies similar to those used by the body it can interfere with physiological functions causing unwanted effects This is avoided by using a frequency beyond those used by the body Alternating current with a very high frequency in the order of 500 kHz does not affect physiological functions RF Generators i
33. in Management Pump Unit e Connect the male connector of the Pain Management Pump Connector Cable to the generator e Connect the female connector of the Pain Management Pump Connector Cable to the Pump Unit e Push the connectors as far in as possible and then tighten by turning the collar clockwise b 2 Plug in the Generator e Plug the power cord into the Pain Management Generator and connect the generator directly to a grounded receptacle e Turn the generator on PM1013 Rev 09 08 Page 12 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 3 Insert Tube Kits into the Pain Management Pump Unit e Remove the Pain Management Tube Kit from the sterile package Put the burette into the Pump Unit s burette holder Open the pump head lid and thread the thicker tubing from the bottom of the burette into the pump head tube holder e Ensure that the tubing is properly placed between the notches and along the center channel beneath the pump head Improper positioning of the tubing can pinch the tube and restrict the water flow e Close the lid in order to hold the tubing in place Leave the luer lock caps on the tubing until you are ready to connect the probes so the inner pathway of the tube kit remains sterile PM1013 Rev 09 08 Page 13 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are tr
34. l Ala PM1013 Rev 09 08 Page 33 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 16 The target point lies at the base of the SAP along its lateral midline This corresponds to a point in the notch vvhere the surface of the bone is still dorsally facing before it curves ventrally towards the intervertebral foramen The target point is visualized using an anterior posterior AP fluoroscopic view The puncture point on the skin is just lateral and inferior to the target Adjustments to the puncture point can be made to ensure that the needle course is medial to the iliac crest The introducer is advanced until contact is made with the target bony endpoint Under AP view the tip of the needle should be up against the base of the SAP and under its lateral margin Note that needle placement is on the dorsal Surface of the bone Placement more superior ventral to the target point brings the electrode closer to the segmental nerve root and increases the risk of inadvertent heating of this structure PM1013 Rev 09 08 Page 34 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 17 Rotation to an oblique view should confirm correct location of the stylet tip at the target point Reposition as
35. lateau or decrease slightly over the remainder of the procedure Typical POWER values range from 2 to 12 Watts ail BAYLIS MEDICAL COMPANY INC MEASUREMENTS 6 1 TIME min 2 90 STIMULATION MODE 1 SAVE VOLTAGE CURRENT TEMP SETTINGS Generator graph of an ideal procedure PM1013 Rev 09 08 Page 41 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued The graph in on this page is similar to the ideal graph except there is a small blip in both lines at about 1 minute This is commonly seen if the patient moves to get more comfortable or coughs t may also be seen if the probe is bumped or moved This is likely not a problem but it is a good idea to check the lateral and AP fluoroscopy views to make sure the probe is still in a desirable position FT aan BAYLIS MEDICAL COMPANY NC ol MEASUREMENTS TEMP 1 2 SET TEMP C A COOLED RF DATA TIME min 100 va 2 30 0 1 2 STIMULATION MODE VOLTAGE CURRENT a a s nu uu x r OUTPUT aNG m 1 on PAIN MANAGEMENT GENERATOR acca Sea Ng OFF O L 2 Gene
36. n oral analgesics or other methods depending on physician and institution preference The patient should be relaxed and able to communicate throughout the procedure General anesthesia should be avoided CAT PM1013 Rev 09 08 Page 20 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Sacroiliac Joint Neurotomy Procedural Technique A technique for lesioning the lateral branches of the S1 thru S3 dorsal roots using the Pain Management Slnergy System is provided Subsequent pages detail a technique for lesioning the L5 dorsal ramus using the same equipment Fluoroscopic images provided courtesy of Dr Robert E Wright Denver Pain Management and Dr Paul Dreyfuss Washington Interventional Spine Associates Sacroiliac Joint Neurotomy 51 53 Lateral Branches 1 Obtain an anterior posterior A P fluoroscopic image by aligning the L5 S1 vertebral end plates The S1 S2 and S3 posterior sacral foramina should be identifiable If not the image can be rotated 10 15 degrees in the ipsilateral direction or as required in order to better visualize the posterior sacral foramina PM1013 Rev 09 08 Page 21 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 2 A thin gauge needle is gently placed
37. n the Market Today Today modern AC generators use a frequency between 400 and 600 kilohertz which is in the radiofrequency RF range and are generally referred to as RF generators RF generators are now equipped with automatic temperature control and impedance monitoring Temperature control allows for effective lesion formation whereas impedance monitoring detects changes in tissue resistance to electric current Impedance monitoring also aids in electrode placement because impedance varies between different tissues Monopolar Electrode Systems Monopolar System Physics n medical applications RF current is delivered to tissue by an electrode usually on the end of a probe or insulated cannula lonic heating of tissue is a function of the current density or current per unit area RF current flows out of the electrode radially and as a result current density progressively decreases away from the electrode This is illustrated in Figure 2 where a circle represents an electrode and arrows represent the current flowing radially from the electrode The current shown by the arrows is denser in areas closer to the electrode Consequently ionic heating is greatest at the proximity of the electrode and decreases with increasing distance RF devices often contain temperature sensors Note that the electrode itself does not heat up Instead the tissue heats from ionic heating and the heat conducts back to the electrode where the sensor indi
38. ncy energy application Internally cooled electrodes Application specific electrode design Impedance monitoring User friendly design and interface PM1013 Rev 09 08 Page 7 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 5 Technical Description of the Equipment Overvievv In this section you are going to learn about all of the components of the Slnergy System You will learn the function of each device and the relationship of the device within the system Baylis Pain Management Generator Model PMG TD V2 2 or higher Important features A software based computerized radiofrequency generator e Several safety features are incorporated into the control algorithm For example the generator can detect broken or improperly set up equipment and give appropriate error messages t is designed to power and control the pump unit and provide automatically controlled parameters designed for the procedure Pain Management Pump Unit Model TDA PPU 1 Important features ua e The pump unit circulates sterile water through TAN the Slnergy Probe This is achieved via closed loop fluid circuit The closed loop fluid circuit includes a Pain Management Tube Kit and a Slneroy Probe e The Pain Management Pump comes with a connector cable which connects it to the generator PMG TD for po
39. necessary to obtain appropriate needle position 18 A lateral view is obtained to confirm depth of needle placement The tip of the stylet should be no deeper than the AP midline of the SAP which can be approximated by the joint space of the L5 S1 zygopophysial joint PM1013 Rev 09 08 RIGHT LATERAL Max Insertion depth L5 S1 z joint space 4 4 Page 35 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 19 Remove the stylet from the introducer A small volume less that or equal to 1cc of local anesthetic is optionally administered to the target site through the introducer Place the SInergy Probe into the introducer ensuring that it is seated snuggly in the hub On lateral view the tip of the probe should be 2 mm proximal to the tip position previously observed for the stylet This is to accommodate the distal project of the lesion from the tip of the electrode Note that there will be up to 4mm of distal lesion projection from the tip of the electrode Ensure there is adequate distance between the tip of the electrode and the foramen of the L5 segmental nerve root to minimize the risk of inadvertent heating to this structure 20 A lesion is created around the tip of the electrode as previously described Suggested lesion parameters remain unchanged Set Temperature 60 C Time 2
40. ns for Use for each component must be read prior to use PM1013 Rev 09 08 Page 2 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 3 Physics of the Pain Management Sinergy System Overvievv This section briefly explains how the Sinergy System heats nervous tissue In this section you will learn e The reason why high frequency alternating current is used to heat tissue The reason why the Sinergy Probes are internally cooled Direct Current amp Alternate Current Electric current refers to the amount of charge that passes through a surface per measure of time At an atomic level current is the flow of electrons A current that moves in the same direction around a circuit is referred to as Direct Current DC A current whose direction alternates continuously back and forth is referred to as Alternating Current AC see Figure 1 The number of times that the current alternates back and forth in a second is known as frequency Frequency is measured in Hertz For example 60 Hertz means that the current alternates back and forth 60 times per second Current Current Time Time Direct Current DC Alternate Current AC Figure 1 Direct Current DC and Alternate Current AC signal amplitudes Resistive Heating with DC Electrical conductance is the property of a material that determines the ability of curr
41. ntous tissue along the surface of the sacrum can be dense and difficult to penetrate S1 8 00 PM1013 Rev 09 08 Page 25 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 6 Confirm the depth of the stylet and introducer by rotating the image to a lateral vievv The stylet and introducer should be at the sacral surface and must not have slipped into the sacral foramina Not infrequently especially at 51 one needs to advance further through very tough tissue to obtain the target position PM1013 Rev 09 08 Page 26 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 7 Rotate the C arm back to an A P view Remove the stylet from the introducer A small volume less that or equal to 1cc of local anesthetic is optionally administered to the target site through the introducer Place the Sinergy Probe into the introducer ensuring that it is seated snuggly in the hub Note that the Slnergy Probe is 2 mm shorter that the stylet The probe is designed to sit 2 mm off of the dorsal sacral surface to ensure that the thermocouple is not shielded in bone and that the lesion does not extend unnecessarily into the periosteum The impedance displayed on the screen of the Pain Management Generator should not exce
42. or accurate placement of the probe Pain Management Tube Kit Model TDA TBK 1 Important features One tube kit is required for a procedure 115 used for circulation of sterile 1 water through the SInergy Probe a the purpose of cooling the electrode The Pain Management Pump Unit pumps vvater through the tube kit s The Tube Kit comprises medical 4 grade tubing and a burette that holds sterile vvater SB PM1013 Rev 09 08 Page 9 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Pain Management Epsilon Ruler Model SIA E10 Important Features e Open circular stainless steel ruler with a 10 mm radius and 10 mm central spoke length e Used during the procedure to measure a safe distance between the sacral foramina and the electrode 6 Patient Selection Candidates for sacroiliac joint neurotomy must have a history of chronic sacroiliac joint complex pain for at least 6 months and meet the selection criteria It is important to adhere to these criteria for the safety of the patient and success of the treatment The physician must be trained to diagnose sacroiliac joint complex mediated pain Selection Criteria Candidates for the Sacroiliac Joint Neurotomy procedure must meet the following inclusion criteria e Predominantly axial pain below the L5 vert
43. p between the active tip and bony endpoint This will achieve the appropriate electrode depth for treatment Ensure that the probe is seated firmly in the introducer before proceeding e The stylet should always be replaced in the introducer prior to repositioning The electrode is not designed to create new pathways through the dense connective tissue along the surface of the sacrum Ensure that the electrode does not make physical contact with the finder needle during RF delivery PM1013 Rev 09 08 Page 17 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Lumbo Sacral Anatomy Fluoroscopic Image This is an A P vievv of a lumbo sacral spine showing the SI joint margin the sacral foramina and the sacral ala Illustration of Sacrum Compare the above image with this illustration of the posterior sacral surface SI Joint Margin PM1013 Rev 09 08 Page 18 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Sacroiliac Joint Innervation Lateral branches of the posterior rami are responsible for relaying nociceptive signals from the SIJ and the surrounding structures to the CNS Anatomical studies suggest that the number and running course of these lateral branches is variable
44. rator graph showing a small blip is okay PM1013 Rev 09 08 Page 42 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued The graph in on this page is also similar to the ideal graph except that the POVVER has reached the povver limit of 12VV for a short period of time during the beginning of the procedure As a result it has taken about 15 seconds longer than usual for the COOLED RF TEMP to reach SET TEMPERATURE This is periodically seen when the probe has been placed in particularly dense connective tissue The power limit has ensured that the lesion formed in a safe and uniform manner If the SET TEMPERATURE is unable to reach SET TEMPERATURE because of this feature stop the procedure and reposition the electrode 4 5 BAYLIS MEDICAL COMPANY INC o TIME min SET TEMP CC 2 07 7 7 lt Asi RF DATA PUMP TIME min 7 71 lt A Y ap w z y 0 1 2 i STIMULATION MODE i AUTO SAVE VOLTAGE CURRENT TEMP SETTINGS N l PAIN MANAGEMENT GENERATOR x LE Generator graph showing that reaching the power limit is okay PM1013 Rev 09 08 Page 43 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or regis
45. rror code and contact technical support if problem persists PM1013 Rev 09 08 A Pump Malfunction Ensure pump lids are fully closed and cable is securely connected Pump unit may be defective Dynamic Probe Pump Mapping Failure Check probe and cable connections ensure fluid circuitry is connected correctly and free from obstruction Repeat priming while squeezing the upper and lower jaw of the pump head Probe s or cable s may be defective Contact technical support if problem persists A Pump Current Limit Check pump unit and ensure cable is securely connected Contact technical support if problem persists A Cooled Temperature Out Of Range Outside 18 34 C expected range Probe s cable s or pump unit may be defective A Probe A Not Connected Check probe and cable connections Probe or cable s may be defective A Invalid Probe A Temperature Reading Check probe and cable connections Probe or cable s may be defective Try new probe and cable s if problem persists Page 51 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued LCD Text Message A High Impedance Detected Check probe and cable connections Possible poor tissue contact Probe s or cable s may be defective A Low Impedance Detected Possible short circuit between electrodes or damaged introducer in
46. ssued 12 The same sequence of steps is repeated to create a lateral arc of treated tissue around the S2 dorsal foramen lesioning at the 4 o clock 2 30 o clock and 5 30 o clock positions 8 o clock 9 30 o clock and 6 30 o clock positions on the left side S2 8 00 S2 9 30 PM1013 Rev 09 08 Page 31 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 13 The same sequence of steps is also repeated to create a lateral arc of tissue around the S3 dorsal foramen this time only lesioning at the 2 30 o clock and 4 o clock positions 9 30 o clock and 8 o clock positions on the left side 53 9 30 S3 8 00 S3 4 00 S3 2 30 PM1013 Rev 09 08 Page 32 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 14 After completing the lesions at S3 there is a continuous band of ablative lesions between the sacral foramina and the sacroiliac joint L5 Dorsal Ramus Neurotomy 15 Needle placement for this procedure is similar to that for a diagnostic lumbar medial branch block at the same level The target location is the notch between the ala of the sacrum and the superior articular process SAP of the sacrum This corresponds to the known running course of the L5 dorsal ramus Sacra
47. sulation A High Impedance Detected Check probe cable and dispersive return electrode connections Possible poor tissue contact Probe or cable may be defective A Low Impedance Detected Possible short circuit between electrodes or damaged introducer insulation PM1013 Rev 09 08 Page 52 of 56 Baylis Medical Company Inc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Loose connections Trouble Shooting Flow Chart Legend Errors 80 to 87 mi Error Persists gt Error Clears gt See additional text Ensure connectors are dry Check connections After drying if error clears moisture on the connector caused the error Not necessary for E80 One of the devices is Reposition Independently probe ensure Swap probe and probe is fully cable Swap damaged inserted into cable only for introducer E87 Swap probe Both of the and cable at the devices are same time Not damaged applicable to E87 Probe may have had poor tissue contact or not fully inserted in introducer Internal error resolved by reboot Turn PMG ON OFF Internal error requires repair Call Clinical Support PM1013 Rev 09 08 Page 53 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of
48. t to the electrode vvith cool vvater a larger volume lesion can be created This is accomplished by increasing the time of the procedure or the energy output of the RF generator Temperature Non cooled Cooled Distance Probe Figure 3 Temperature distribution of non cooled and cooled RF electrodes The circulation of coolant through an electrode also affects the shape of the lesion A monopolar cooled RF electrode for example can be designed to create a lesion that is either spherical or elliptical in shape A portion of this lesion can project distally from the probe heating tissue that might otherwise be difficult to access These distinct lesion characteristics allow perpendicular electrode placement towards the target In the case of the spherical lesion created by the Slnergy System varying degrees of obliquity will have no effect on the orientation of the lesion Figure 4 Figure 4 Spherical lesions allow perpendicular or oblique placement towards the target structure PM1013 Rev 09 08 Page 6 of 56 Baylis Medical Company nc 2007 Slnergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 4 Benefits of the Pain Management Sinergy System nternally Cooled for Greater Power Applications The Sinergy System electrodes are internally cooled which allows for greater power to be delivered Increasing power enables the creation of large
49. ter volume of tissue to be heated until thermal equilibrium is reached The optimum Time is long enough for adequate volume heating without excessive procedure time Time can be changed at any time before or during the RF delivery Power Limit is the maximum power in Watts that the generator will output at any time during the procedure Power output will vary throughout the procedure as required to achieve the desired Ramp Rate and Set Temperature Typically power values are higher during the temperature ramp and lower once the probe has reached Set Temperature If the Power Limit is reached during temperature ramp the generator will continue to deliver RF at this maximum value This may increase the Ramp Rate by several seconds but will ensure that the lesion forms in a safe and consistent manner lf the Power Limit is set too high it is possible to have irregular lesion shapes or excessive heating Refer to the following page for the suggested lesion parameters PM1013 Rev 09 08 Page 39 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Suggested Parameters The suggested parameters used for treating a patient with the Slnergy System are Set Temperature 60 C Ramp Rate 80 C min Time 2 30 minutes These parameters were tested and scrutinized through a series of bench tests and in vivo experiments The
50. tered trademarks of Baylis Medical Company Inc Patents pending and or issued An example of a graph that indicates a poor procedure is shown below The COOLED RF TEMP and POWER lines have become erratic indicating that the electrode is not able to deliver RF energy in a consistent manner for this tissue location This will likely be accompanied by a higher that normal impedance reading gt 500 Q This may be caused by tissue inhomogeneity around the active tip of the electrode or by placing the active tip in dense connective tissue or bone Immediately stop the procedure and reposition the electrode BAYLIS MEDICAL COMPANY INC MEASUREMENTS 0 38 i COOLED RF DATA TIME min j 2 30 av 0 1 2 wv P STIMULATION MODE VOLTAGE CURRENT A outeur 7 N ee mes Q J PAIN MANAGEMENT GENERATOR _ 2 O J a 1 Generator graph of a procedure PM1013 Rev 09 06 Page 44 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued 11 Troubleshooting Overvievv In this section you will e Learn how to identify potential problems with system components e Become familiar with the Generator Error and Fault Codes that may appe
51. wer and speed control Pain Management Cooled RF Connector Cable Model CRX BAY CRP Important features Used to connect SInergy Probe to the generator Provides access to the Cooled RF mode in the generator Transmits RF energy from the generator to the probe Transmits signals from the temperature sensor in the probe to the generator PM1013 Rev 09 08 Page 8 of 56 Baylis Medical Company nc 2007 Sinergy and Epsilon are trademarks and or registered trademarks of Baylis Medical Company Inc Patents pending and or issued Pain Management Sinergy Probe Model SIP 17 150 4 and SIP 17 75 4 Important features e One probe is required for a procedure e The probe delivers RF energy creating a spherical lesion centered about the active tip e Sterile water is circulated internally within the electrode during the procedure which cools the electrode The sterile water is contained and does not contact patient tissue e Each probe has a temperature sensor at the distal end of the electrode The temperature sensor measures temperature and provides control of RF energy delivery throughout the procedure e Each probe includes a 4 cable and tubing extension to reach out of the Sterile field Pain Management Sinergy Introducer Model 51 17 150 and 51 17 75 Important features e An introducer is comprised of a fully insulated cannula and a sharp trocar tipped stylet e The 17 gauge introducer allows f
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