PMG
V4.2
User’s Manual
PMG-Basic
PMG-Advanced
15-H1-654-0-01 / 025-0169-420 REV B
COOLED RADIOFREQUENCY
PAIN MANAGEMENT
GENERATOR
*
Avanos Exhibit 2069 Page 1
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-00895
Page 1: ...2 User s Manual PMG Basic PMG Advanced 15 H1 654 0 01 025 0169 420 REV B COOLED RADIOFREQUENCY PAIN MANAGEMENT GENERATOR Avanos Exhibit 2069 Page 1 Medtronic Inc v Avanos Medical Sales LLC Case IPR202...
Page 2: ...2 Avanos Exhibit 2069 Page 2 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Page 3: ...ON SETTINGS State 25 7 7 2 ADVANCED SETTINGS Mode LESION SETTINGS State 26 7 7 3 ADVANCED SETTINGS Mode TRANSDISCAL SETTINGS State 27 7 7 4 1 ADVANCED SETTINGS Mode MULTI COOLED RF1 SETTINGS State 28...
Page 4: ...Multi RFAUTOTEMPLESION ONDisplay 19 Figure7 14 Multi RFAUTOPULSED ONDisplay 19 Figure7 15 COOLEDRFAUTOTEMP ONDisplay 19 Figure7 16 MULTI COOLEDRF ONDisplay 19 Figure7 17 TRANSDISCALMONOPOLARTREATMENT...
Page 5: ...that comprise the machine steps necessary to complete a procedure The modes for this Generator include Current Stimulation Voltage Stimulation AutoTemp Lesion Manual Power Lesion Auto Pulsed Lesion M...
Page 6: ...ying actual power or voltage delivered measured probe temperature s time of power duration and measured impedance The use of a dispersive return electrode is specified in the accompanying IFUs of prob...
Page 7: ...may induce hazardous currents The cables to the surgical electrodes should be positioned in such a way that contact with the PATIENT or other leads are avoided Temporarily unused ACTIVE ELECTRODES sh...
Page 8: ...This includes the PMX PMP PMC PMF TDX TDP TDI TDA CRX and CRP line of products 5 User Interface Overview Figure5 1Generatorfrontpanel 5 1 Front Panel Displays Controls and Connections Descriptions of...
Page 9: ...acquired during RF output in lesion states for ON states when in the LESION mode and treatment states when in COOLED RF TRANSDISCAL RFA and IDL modes The horizontal axis is time corresponding to the t...
Page 10: ...Hz 2 Hz PULSE DUR 0 1 0 2 0 5 1 0 ms 1 0 ms CURRENT 0 0 10 0 mA 0 0 mA AUTOTEMP LESION SETTEMP 38 95 C 80 C TIME 15 600 s 75 s MULTI RF TRUE TX MAX RAMPTIME EXTENSION DISABLE 5 120 s with 5 s interval...
Page 11: ...lights during a portion of the System Initialization state Figure7 1SystemInitializationStateDisplay The POST state is initiated after System Initialization is completed It lasts about 30 seconds Fig...
Page 12: ...None N A None STATE PARAMETERS MeasurementWindow StatusWindow Available States Available Settings Status Description Status Description Status Description Status Description System Initialization N A...
Page 13: ...nnecting Cable is used If the position of the switch on the Switching Cable does not concur TREATMENT mode is not selectable WhenTreatment mode is selected the Generator will enter the READY state of...
Page 14: ...er than 0 00V for Stimulus pulses to be delivered CURRENT STIMULATION Stimulus pulses are not delivered during the READY state During the ON state Current must be greater than 0 00 mA for Stimulus pul...
Page 15: ...IMULATION AUTOTEMP MANUAL POWER AUTO PULSED MANUAL PULSED SAVE SETTINGS While in the READY state other operating modes for HALYARD Pain Management Thermocouple probes are available When a different mo...
Page 16: ...nge 15 600 s Increment 1 s Default 75 s MANUAL POWER LESION TEMP LIMIT Range 38 95 C Increment 1 C Default 80 C TIME Range 15 600 s Increment 1 s Default 75 s POWER LIMIT Range 0 50W Increment N A Def...
Page 17: ...uple Probe are displayed Impedance measurement for RFA is displayed Time and Power are not displayed dashed lines replace values If the Thermocouple Probe is disabled via RFA SETTINGS in the ADVANCED...
Page 18: ...CURRENTSTIMULATION ONDisplay Figure7 9AUTOTEMPLESION ONDisplay Figure7 10MANUALPOWERLESION ONDisplay Figure7 11AUTOPULSEDLESION ONDisplay Figure7 12MANUALPULSEDLESION ONDisplay Avanos Exhibit 2069 Pag...
Page 19: ...EMP ANDTRANSDISCALTREATMENT states consist of PRE TREATMENT COOLING TREATMENT ON and POST TREATMENT COOLING if enabled from ADVANCED SETTINGS Figure7 15COOLEDRFAUTOTEMP ONDisplay Figure7 16MULTI COOLE...
Page 20: ...7TRANSDISCALMONOPOLARTREATMENT ONDisplay Figure7 18TRANSDISCALBIPOLARTREATMENT ONDisplay Figure7 19RFAMODETREATMENT ONDisplay Avanos Exhibit 2069 Page 20 Medtronic Inc v Avanos Medical Sales LLC Case...
Page 21: ...21 Figure7 20IDLMODE ONDisplay SecondaryThermocoupleDisabled Avanos Exhibit 2069 Page 21 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Page 22: ...ed during Stimulus pulse delivery A tone is generated for two seconds at the conclusion of the procedure Impedance Related Audio Output OFF Impedance related audio output is not generated during the O...
Page 23: ...ment 1 s MANUAL POWER LESION TEMP LIMIT Range 38 95 C Increment 1 C TIME Range 15 600 s Increment 1 s POWER LIMIT Range N A Increment N A AUTO PULSED LESION SETTEMP Range 38 95 C Increment 1 C TIME Ra...
Page 24: ...TINGS During ON state SETTIME should not be decreased below INITIALTIME in ADVANCED SETTINGS SET TEMP Range 40 95 C Increment 1 C TIME Range 30 s 20 min Increment 30 s Availablevaluesmaybelimitedtotwo...
Page 25: ...IMULATION SETTINGS screen Settings on this screen apply to bothVOLTAGE and CURRENT STIMULATION This mode allows the user to limit the quantity of selectable values in Stimulation Modes to two frequent...
Page 26: ...s when LESION SETTINGS is selected from the ADVANCED SETTINGS Mode This screen allows adjustment of the initial RAMPTIME taken by the AUTOTEMP LESION and AUTO PULSED LESION modes to attain the SETTEMP...
Page 27: ...DiscWarningTemperature the rate of the Output ON tone increases the tone is played more often This screen allows adjustment of the RAMP RATE used by theTRANSDISCAL mode to attain the SETTEMPERATURE Se...
Page 28: ...e an error notification will be generated This feature can be turned off by changing the setting to DISABLE Figure7 25aADVANCEDSETTINGSMode MULTI COOLEDRF1SETTINGSDisplay Settings Affected Mode Parame...
Page 29: ...NG IMPEDANCE Refer to the EXAMPLE shown in Figure 7 25b for details If the IMPEDANCE CUTOFF MULTIPLIER is DISABLED thenWarning W221 is generated at 1000 Figure7 25bADVANCEDSETTINGSMode MULTI COOLEDRF2...
Page 30: ...ial to change SET POWER LIMIT Figure7 26ADVANCEDSETTINGSMode COOLEDRFSETTINGSDisplay Settings Affected Mode Parameter DESCRIPTION Range Units DefaultValue Increment Cooled RF Auto Temp Mode RAMP RATE...
Page 31: ...the RFA andTransDiscal Placement Modes Enabling Impedance Audio in All Ready States enables the tone in the AutoTemp Manual Power Auto Pulsed Manual Pulsed Cooled RF AutoTemp TransDiscalTreatment Mode...
Page 32: ...EAKTEMP 15 60 s 1 10 min 15 s 1 s for 15 60 s 30 s for 1 10 min 7 7 8 ADVANCED SETTINGS Mode IDL SETTINGS State The following screen appears when IDL SETTINGS is selected from the ADVANCED SETTINGS mo...
Page 33: ...re7 30RecoverableErrorPop UpDisplay 7 8 1 1 Display Yellow error indicator will display on screen Error text will display in the center of the screen within the Status window 7 8 1 2 Settings In all m...
Page 34: ...specified voltage and current limits Applied part of patient circuit is not referenced to earth at high frequency The maximum output of 50W is restricted by Maximum voltage 160Vrms Maximum current 0...
Page 35: ...MG operates over the ACVoltage range of 100VAC 240VAC When replacing fuses ensure the integrity of the new fuses by inspecting for physical damage that could affect the function of the fuse Use a prec...
Page 36: ...36 8 15 Output Power Graphs Figure8 1Powervs LoadandPeakVoltage Avanos Exhibit 2069 Page 36 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Page 37: ...ticular installation Portable and mobile RF communications equipment can affect medical electrical equipment Table8 2 IEC EMC Specifications Emissions Guidance and Manufacturer s Declaration Electroma...
Page 38: ...cial or hospital environment NOTE UT istheACmainsvoltagepriortoapplicationofthetestlevel Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3Vrms 150 kHz to 80 MHz 3V m 80 MHz to 2 5 GHz 3Vrms 3V m...
Page 39: ...to the transmitter manufacturer NOTE 1 At80MHzand800MHz theseparationdistanceforthehigherfrequencyrangeapplies NOTE 2 Theseguidelinesmaynotapplyinallsituations Electromagneticpropagationisaffectedbyab...
Page 40: ...propriate sized active electrode tip to achieve the desired lesion size ActiveTip size Lesion Size and Shape T 60 C Typical Anatomy Placement Distal Projection Average 2 mm 4 6 mm Oblate Spheriod Cerv...
Page 41: ...e Return Electrode connection Up V Down W Earth Ground Federal law U S A restricts this device to sale by or on the order of a physician Rx ONLY Footswitch Fuses Manufacturer MeasuredTemperature Non I...
Page 42: ...ll be issued a thirty day 30 warranty against defects in both materials and workmanship provided the original warranty period has passed Instruments submitted due to defects in materials and workmansh...
Page 43: ...43 Avanos Exhibit 2069 Page 43 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Page 44: ...GA 30004 USA Halyard Belgium BVBA Leonardo Da Vincilaan 1 1930 Zaventem Belgium Registered Trademark or Trademark of Halyard Health Inc or its affiliates 2015 HYH All rights reserved KIMBERLY CLARK i...
