G4 Generator. Four-Electrode Radiofrequency Generator. The Leader in RF Medicine Since 1952

Transcription

1 G4 Generator Four- Radiofrequency Generator The Leader in Medicine Since 1952

2 Pioneers of Radiofrequency Cosman s Historic Firsts in Medicine Landmark inventions by Bernard J Cosman, MS (MIT) and MIT Professor Eric R Cosman, Sr, PhD Founded and owned Radionics, the world leader in medicine until its sale s First commercial radiofrequency generator (1952) First temperature-monitoring electrode First impedance monitor 1960 s First facet denervation electrode with Dr. Shealy First trigeal neuralgia electrode with Dr. Sweet First cordotomy electrode with Dr. Rosomoff 1970 s First medial branch TC electrode with Dr. Sluijter First curved trigeal electrode with Dr. Tew First TC cordotomy electrode with Dr. Levin First DREZ electrode with Dr. Nashold 1980 s First intradiscal heating with Dr. Sluijter First cardiac ablation generator First CT cordotomy electrode with Dr. Kanpolat 1990 s Invented pulsed (P) with Dr. Sluijter et al. First pulsed generator, the G-3C+ First curved cannulae with Drs. Racz & Finch First generator for tumor ablation First cooled electrode with Dr. Goldberg The Next Generation of Innovation The latest advances from Prof Eric R Cosman, Sr, PhD and Eric R Cosman, Jr, PhD (MIT) 2004-present Founded Cosman Medical. G4 four-electrode, touch-screen generator G-1A & 1B generators with simplified controls Fundamental discoveries in & P biophysics 1, 2 First palisade for sacroiliac joint (SIJ) pain s G s G-3A 1970 s G s G-3B 1990 s G-3C+ 1971: MIT Professor Eric R Cosman, Sr, PhD and his father, Bernard J Cosman, MS (MIT) in the Radionics booth at the American Association of Neurological Surgeons (AANS) congress. 2007: Eric R Cosman, Jr, PhD (MIT) and his father, Professor Eric R Cosman, Sr, PhD in the Cosman Medical exhibition booth at the International Spine Intervention Society (ISIS) congress. 1 Cosman ER Jr, Cosman ER Sr. Electric and Field Effects in Tissue Around Radiofrequency s. Pain Medicine 2005; 6(6):

3 Superior, Efficiency, and Ease of Use The Most Advanced Generator Ever Built ersion 2 of the popular G4 generator builds on Cosman s tradition of performance, safety, and quality in pain management and neurosurgery with the widest available range of features: Intuitive 12 touch screen Large color-coded readings control with knob or screen Automatic stimulation ramp Simultaneous or stagger start of electrodes Two interface options: One Touch: Simple, digital Graphing: Advanced, graphical Enough power to heat four 16ga cannula Multi-bipolar for SI joint pain E-dose control Full operability with 12 touch screen or wireless remote. The upright screen is visible from a distance. Optional knob control. Unparalleled Capability. Unmatched Simplicity. Wireless Remote Control Nitinol, standard, or disposable electrodes. Smooth steerable cannulae of all sizes. 10mm 12mm Treat Four Sites At Once Automatic and Independent Control. Simultaneous or Auto Stagger Start. Faster & s. 15mm SI Joint Palisade TM Kit Bipolar and guide block produce a more complete SIJ lesion zone with fewer lesions. 3 Create two bipolar lesions at once. Genicular Treating multiple nerves at the same time can save time and reduce costs. 2 Cosman ER Jr, Dolensky JR, Hoffman RA. Factors That Affect Radiofrequency Heat Lesion Size. Pain Medicine 2014; 15(2): Cosman ER Jr, Gonzalez CD. Bipolar Radiofrequency Lesion Geometry: Implications for Palisade Treatment of Sacroiliac Joint Pain. Pain Practice 2011; 11(1):3-22.

4 Preset: Medial Branch Electorde Type = Standard Active s = 1 Sensory Rate = 50 Hz Senory Width = 1 Sensory Auto Ramp = Off Motor Rate = 2 Hz Motor Width = 1 Motor Auto Ramp = 2.0 Ramp Speed = Fast Control Units = oltage Doctor Info Name = Best Deptartment = Anesthesiology Hospital = University Hospital Set Temp = 90 Set Time = 1:30 Stagger Start = 0 sec Mode = Standard Auto Ramp = On Max Temp = 42 Set Time = 1:30 Set oltage = 45 Pulse Rate = 2 Hz = 20 Stagger Start = 0 sec E-dose = oltage Auto Ramp = On Interface = One Touch Cosman G4: Simple Customizable Workflow with Uni Two Interfaces to Satisfy Diverse Needs Select a different interface for each doctor preset. oltage W 1 100mA One Standard Stepped Set Temp Set Time 1:30 One Touch Interface ery large displays Simplified touch screen controls Useful in a busy practice Choose either the simplicity of full touch screen automation or the precision of manual knob control : ma 1: W One :30 Reset Set Temp Settings Set Temp Set Time 1:30 Mode Standard Auto Ramp On Change Graphing Interface Graph temperature and voltage Knob or touch screen control Useful for advanced treatments 1 Load stored procedure settings, doctor and patient information. Start Patient Database Select Preset Cordotomy Functional Stereotaxy Intradiscal Medial Branch Palisade SIJ Pallidotomy DRG Splanchnic Nerve Sympathectomy Thoracic Medical Branch Trigeal Neuralgia Doctor Presets Store hundreds of procedure settings for multiple doctors. Select Patient Jump to... Edit info... Last Name First Name ID Belden Anne Fritz Albert Holder Richard Jenkins Diane Salinas Carlos Tyler Walter an Dieren Teus Zedillo Miguel New Delete Delete All DOB L3-L5 R Medial Branch T6-7 L/R Medial Branch C2-4 L DRG Trigeal 2/3 R Sacroiliac Joint Palisade L3-L5 L Medial Branch C3-5 L/R DRG L4-5 L Medial Branch Patient Database Store patient names, IDs, DOBs, and notes. Recall on repeat appointments. Modify Presets Cancel Start Cancel Ok 2 Perform procedure. Adjust electrode setup, settings, notes, and site labels as desired. One Motor One One One Type Active s Labels Standard Bipolar Edit Clear All Connect as Shown G Labels 1: Not specified 4 1 oltage Sensory Motor Pulse Rate 2 Hz 1 oltage Ramp 1.2 oltage W 1 100mA Standard Stepped Set Temp Set Time 1:30 42 oltage ma Max Temp 42 Set Time 1:30 Set oltage 45 Pulse 2 Hz 20 Intuitive color-coded screens and large displays 3 Print or export procedure record. Or save on G4 for later export. Print procedure summary directly to a USB printer Export electronic records to USB thumb drive JPEG screen shots for records & presentations Plot & analyze data for clinical research

5 Four s que Automation, Control, and Record Features Four s e Radiofrequency Custom 100 Settings Custom Settings Simultaneous or automatic stagger start of up to four electrodes One One Smooth automatic temperature control for large and small electrodes Displays of all crucial readings: :45 1:30 0 0:45 1:30 0 0:45 1:30 0 0:45 1:30 olts, Milliamps, Watts, 1and Oh 1 One One 100 ma 210 Ω 100 ma 230 Ω 117 ma 150 ma Automatic staggering of electrode activations oltage, current, or power control for multiple non-tc electrodes (CR) 2.0 W 2.1 W 3.2 W 4.5 W quickly identifies problem electrodes Reset Patented technology for energizing 42 multiple electrodes One One Proprietary algorith accelerate heating 42 A broad range of temperature 42 settings 1(37-95 ) 1 Max TempSet Temp Max Temp oltage oltage Intradiscal stepped temperature 70 progra 100 Elapsed 70 Time Max Set Time Temp Max Set Time Temp The oltage widest range of pulse settings: oltage Rate 1-10 Hz, Ω 53 Ω1: :30 Push-button adjustment 42 of the automatic Width 2-30 ec, oltage set temperature during lesioning E-dose: Automatic control of pulse settings to Set Settings Max Set oltage Time Temp Set Max Set oltage Time Temp oltage oltage optimize nerve exposure to 35 the electric 60 field 1 Ω 35 Set 1: Temp Ω : khz waveform for optimal P effect Pulse Set Set oltage Time 1:30 Pulse Set Set oltage Time Low and high-temperature 18 P ( ) ma ma 1 Hz Stagger 45 6 Hz Ω 1:30 7 Ω Start 1: sec Mode Pulse Set oltage Standard Pulse Set oltage ma ma 2 Hz 0 20 Sensory & Motor 6 Auto 45 8 Hz Ramp 455 On 1: :45 1: :45 1:30 Pulse Pulse Automatic : Choose slow or instant-on ramp rate COSMAN G4 ersion COSMAN G4 ersion ma :08 PM ma 4 Hz 102:08 PM 10 Hz 4 Manual : Use knob or on-screen buttons Change Select any P 2, 3,..., 30 ec 00 ma Mark the final 230 stimulation level Ω for 117 true electronic ma record keeping 150 ma Select any P Pulse Rate 1, 2,..., 10 Hz COSMAN G4 ersion COSMAN G4 ersion :08 PM 2:08 PM Audible impedance tone for cordotomy and intradiscal placement W Support for both spinal and 3.2 W neurosurgical procedures: 4.5 W Rate Hz, Width COSMAN G4 ec, ersion voltage or current COSMAN G4 control ersion :08 PM Motor 2:08 PM One User Friendly in Multiple Languages Clear labeling and helpful troubleshooting messages simplify usage in a variety of selectable languages :08 PM Type Active s Labels Four s Reglages Personnalisés Configuration des Électrodes Quatre Électrodes Connect as Shown G Otros Parámetros Configuración de Electrodos 4 Cuatro Electrodos Standard Bipolar Connecter Comme Indiqué G Type Standard Bipolaire Conecte según se muestra G Tipo 3 de 4 Estándar Bipolar Électrodes Actives Edit Positions Labels Electrodos Clear All 1: Not specified Activos 2: Not specified Positions 3: Not specified Modifier Effacer Électrode 1: Non specifié 4: Not specified Électrode 2: Non specifié Etiquetas Etiquetas Électrode 3: Non specifié Modificar Borrar Electrodo 1: Sin especificar Électrode 4: Non specifié Electrodo 2: Sin especificar Electrodo 3: Sin especificar Electrodo 4: Sin especificar Électrodes Thermique Pulsée Terer Electrodos EStim Notas Térmica Pulsada Terar Sensory ma 0.1 ma OFF 2.0 ma 0.5 ma 0.1 ma 250 Ω Ω 37 One Ramp OFF COSMAN G4 ersion :08 PM Sensory Motor Pulse Rate Hz Start Sensory Motor Pulse Rate 2 Hz 1 Ramp 6 ma Select and preset manual or automatic control for sensory and motor modes separately Calibration and Safety Checks Ongoing checks of temperature and other readings confirm accuracy and control. Self-diagnostic tests of hardware and software verify proper function. Reset Set Temp Settings Set Temp Set Time 1:30 Stagger Start 0 sec Mode Standard Auto Ramp On Change

6 Wide Range of Pain Management and Neurosurgical Reliable Thermocouple (TC) s Choose a direct 3-meter connection to the generator, or an extension cable Colored to match cannulae shaft lengths: 5, 10, 15, 20 cm Compatible with both straight and curved cannulae of any gauge Nitinol (TCN) Made from Nickel-Titanium memory metal Improved durability to daily use and autoclaving Nitinol (TCN) Standard (CSK) Disposable (TCD) Standard (CSK) Disposable (TCD) Autoclavable for reuse in multiple procedures Cost-effective and reliable Sold sterile-packed to eliate sterilization planning Eliate the possibility of disease transmission Smooth Steerable Cannulae Straight (CC) or Curved (K) 5, 10, 15, 20 cm shafts 2, 4, 5, 10, 15 mm tips 22, 21, 20, 18, 16 gauge Sharp or Blunt Siliconized Echogenic Curved Sharp (K-C101018S) Curved Blunt (K-C101020B) Straight Sharp (CC101022) SideKick Tapered insulation for smooth maneuvering Disposable Injection s & Needles Keep your target while injecting through long fluid line Tissue piercing, steerable, smooth shafts: 5, 10, 15 cm Small hub with marker for injection direction Injection -Control (CU) Many sizes, straight & curved tips. US Patent 7,862,563. Injection (CR) 5mm tip for voltage-control, shrouded connector Injection (CP) 1mm tip for precise stimulation-guided blocks Block Injection Needle (CN) High quality, reliable, low cost Unitized /Cannula with Injection & Control (CU)

7 s, Cannulae, and Accessories 12mm 10mm Sacroiliac Joint (SIJ) Palisade TM Kit Guide block simplifies alignment and placement of cannulae Bipolar creates larger heat lesions than cooled as used in pain management 2, 3 Bipolar produces a more complete SIJ lesion zone in less time, with fewer lesions, using smaller cannulae 2, 3 Even faster with the G4: Create two bipolar lesions at once 15mm Knee and Hip Pain Radiofrequency ablation is a non-surgical, non-narcotic treatment option for those who are not candidates for invasive surgery Treating multiple nerves at once saves time and reduces costs Flextrode TM Disc Kit An extendable electrode with curved introducer simplifies targeted intradiscal placements Automatic stepped-temperature progra Targeted Intradiscal Trigeal Neuralgia Kits TEW Curved TIC Straight s Cordotomy Kits Autoclavable or Disposable Includes spinal needles Use X-ray or CT guidance Trigeal Neuralgia (TEW, TIC) Cordotomy: Reusable (LCE), Disposable (LCED) Stereotactic Brain s Adapt to most stereotactic frames Thalamotomy, Pallidotomy, Cingulotomy for treatment of movement disorders and intractable pain DREZ Kits Spinal DREZ Kit (NTCD) Nucleus Caudalis Kit (ENA) Stereotaxy (TC): Numerous sizes available DREZ (ENA, NTCD)

8 Percutaneous radiofrequency denervation of lumbo-sacral facet and sacroiliac joints is a simple and effective way to treat spinal pain. Radiofrequency Treatment of the Trigeal Nerve Enables Selective Destruction of Pain Fibers While Preserving Touch and Motor Function in the Face G4 Four-Output Radiofrequency Generator COSMAN Radiofrequency Treatment of the Lumbar Medial Branch by Charles A. Gauci, MD, FRCA, FIPP, FFPMRCA Technique Series COSMAN Percutaneous Stereotactic Radiofrequency Treatment of Trigeal Neuralgia Technique Series by John M.Tew, Jr., MD, FACS, and Andrew Grande, MD Wireless Remote Control (G4-M) Step-by-step Guides Footswitch (FS-1) G4 Cable Organizer (G4-CO) G4 Four- Generator Cordless Ground Pad (DGP-PMC) CR Injection Organizer (CR-CO) Ground Pad (DGP-PM) Sterile Test Pad (G-STP) Test plugs verify calibration and control (G-TP) (480 khz carrier frequency) Auto Temp: Off, Auto Timer: 5 sec 30 Auto Stepped: Start, Step, Final Temps and Times : 0 50 Watts (480 khz carrier frequency) Auto : Off, Auto Timer: 5 sec 30 oltage: olts Peak Rates: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 Hz Widths/Durations: 2, 3,..., 30 ec E-dose: Control oltage or (Biphasic Square Pulses) Rates: 2, 5, 50, 75, 100, 150, 180, 200 Hz Widths/Durations: 0.1, 0.5, 1, 2, 3 ec oltage Control: 0-3 olts Control: 0-10 ma Monitor: Ω Monitor: USB Export: PCL3 Printer, Flash Drive (TXT, JPEG) Size: in 3 ( cm 3 ) Touch Screen: 12.1 in (30.7 cm) Weight: 22 lbs (10 kg) Electric Supply: 100, 120, 220, 240 ac; 50/60 Hz Designed and Built by Cosman Medical Like all Cosman products, the Cosman G4 radiofrequency generator is designed, manufactured, and serviced by our own engineers and technicians to ensure superior quality control, faster service, and cost savings that we pass on to our customers. Cosman Medical, Inc. is an ISO certified company. The G4 is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, and for lesioning nerve tissue for functional neurosurgical procedures. Part # G4 G4-M FS-1 G-STP G-TP SC-2 CB112-TC CB114-TC CB116, CB116-4 DGP-PM-5,10,25 G-1A & 1B One- Generators Description Four- Generator Wireless Remote Control Foot Switch Sterilizable Test Pad with Cable Output Test Plug Storage and Carrying Case 2.4 m Cable, Connects TC to G4 2.4 m Cable, Connects Disposable TC to G4 2.4 m Cable, Connects CR/CP (s) to G4 Disposable Ground Pad, 5, 10, or 25/pk Rx Only. Read Instructions for Use before use. Some products not available in all countries. Tel: Fax: info@cosmanmedical.com 2016 Cosman Medical, Inc. Cosman Medical, Inc. 22 Terry Avenue Burlington, MA USA SPI11682 Rev C