20
Figure 7-17 TRANSDISCAL MONOPOLAR TREATMENT — ON Display
Figure 7-18 TRANSDISCAL BIPOLAR TREATMENT — ON Display
Figure 7-19 RFA MODE TREATMENT — ON Display
Avanos Exhibit 2069 Page 20
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089
Страница 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...
Страница 2: ...2 Avanos Exhibit 2069 Page 2 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 18: ...CURRENTSTIMULATION ONDisplay Figure7 9AUTOTEMPLESION ONDisplay Figure7 10MANUALPOWERLESION ONDisplay Figure7 11AUTOPULSEDLESION ONDisplay Figure7 12MANUALPULSEDLESION ONDisplay Avanos Exhibit 2069 Pag...
Страница 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...
Страница 20: ...7TRANSDISCALMONOPOLARTREATMENT ONDisplay Figure7 18TRANSDISCALBIPOLARTREATMENT ONDisplay Figure7 19RFAMODETREATMENT ONDisplay Avanos Exhibit 2069 Page 20 Medtronic Inc v Avanos Medical Sales LLC Case...
Страница 21: ...21 Figure7 20IDLMODE ONDisplay SecondaryThermocoupleDisabled Avanos Exhibit 2069 Page 21 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 39: ...to the transmitter manufacturer NOTE 1 At80MHzand800MHz theseparationdistanceforthehigherfrequencyrangeapplies NOTE 2 Theseguidelinesmaynotapplyinallsituations Electromagneticpropagationisaffectedbyab...
Страница 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...
Страница 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...
Страница 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...
Страница 43: ...43 Avanos Exhibit 2069 Page 43 Medtronic Inc v Avanos Medical Sales LLC Case IPR2020 0089...
Страница 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...
