Stryker RF MultiGen 0406-900-000 Instructions For Use Manual Download

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DSGN-fm-50366 rev. None

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Effective: July 1, 2008

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Stryker Instruments

(269) 323-7700
(800) 253-3210

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8.5 inch (width) x 11 inch
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Instructions For Use

0406-900-702

Summary of Contents for RF MultiGen 0406-900-000

Page 1: ... the document should not appear on produced Labels or IFUs Description Type Stryker Instruments 269 323 7700 800 253 3210 Print Location Suppliers Services Part Number Rev 8 5 inch width x 11 inch Booklet Print Center Four Color Graphics on White Background 20 Bond or Equivalent N A N A Instructions For Use 0406 900 702 E ...

Page 2: ...Instructions For Use 2014 05 0406 900 702 Rev E www stryker com Interventional Spine IVS RF MultiGen Generator 0406 900 000 5 x Software Version ENGLISH EN ...

Page 3: ......

Page 4: ... Bipolar Combination Procedure Using a MultiGen Cable 18 To Configure a Parallel Bipolar Procedure Using MultiGen Cable s 19 To Start A Procedure 20 To EDIT Sensory or Motor Stimulation Settings 21 To Perform Sensory or Motor Stimulation 23 To EDIT RF Output Settings 24 To Control RF Output 26 To Start Single Electrode s separately or staggered 26 To Start Multiple Electrodes concurrently 28 To Pe...

Page 5: ...ment Concerning Radio Frequency Interference 44 Specifications 45 Disposal Recycle 49 Appendix A RF Hand Controller Instructions 49 Intended Use 49 Features and Functions 49 Appendix B Maximum Frequency and Maximum Stimulation Width Graphs 52 Appendix C Relative Lesion Sizes and Shapes parallel bipolar only 52 Appendix D DualWave Waveform 54 Appendix E Radio Frequency Output Plot 54 Appendix F Fac...

Page 6: ... INACTIVE 25 Figure 21 RF Output PULSE Preset Dashboard 25 Figure 22 RF Output Screen START CONFIRM Dashboard 26 Figure 23 RF Output Screen THERMAL mode ACTIVE 27 Figure 24 RF Output Screen PULSE mode ACTIVE 27 Figure 25 RF Output Screen THERMAL mode INACTIVE SELECTED AND LOCKED ELECTRODES 1 2 and 3 28 Figure 26 RF Output Screen THERMAL mode PARALLEL BIPOLAR ACTIVE 29 Figure 27 RF Output Screen PU...

Page 7: ...2 mm x 5 8 mm width x length 52 Figure 48 Contiguous Lesion 7 8 mm x 9 6 mm width x length 52 Figure 49 Non contiguous Lesions 4 4 mm x 7 5 mm width x length 5 0 mm x 8 2 mm width x length 53 Figure 50 Non contiguous Lesions 4 7 mm x 8 5 mm width x length 5 1 mm x 8 2 mm width x length 53 Figure 51 DualWave Waveform 54 Figure 52 RF Output Plot 54 ...

Page 8: ...ton wool or gauze that is saturated with oxygen Take special precautions regarding electromagnetic compatibility EMC when using medical electrical equipment like this system Install and place this system into service according to the EMC information contained in this manual Portable and mobile RF communications equipment can affect the function of this system DO NOT use this equipment with patient...

Page 9: ...evice is intended for a single use only A single use device may not withstand chemical chemical vapor or high temperature sterilization reprocessing Design features may make cleaning difficult Reuse may create a serious risk of contamination and may compromise the structural integrity of the device resulting in operational failure Critical product information may be lost if the device is re packag...

Page 10: ...een placed in the general location the electrode is inserted into the cannula Sensory stimulation and motor stimulation are used to facilitate the proper placement of the electrode cannula before lesion creation Targeting information is provided by monitoring tissue impedance and providing low frequency stimulating signals to obtain additional information Sensory stimulation controls are used to c...

Page 11: ... G Parallel Printer Cable Port back panel Allows the installation of a PCL3 compliant printer H Power Receptacle back panel Allows the installation of a power cord I Equipotential Grounding Lug back panel Allows the installation a equipotential ground connection Symbol Definitions The symbols located on the equipment and or labeling are defined in this section or in the Symbol Definition Chart See...

Page 12: ...d part F Monopolar Electrode Delivers energy to the monopolar cannula and measures the temperature at the treatment site applied part G MultiGen Cable Provides the connection interface between the generator and a maximum of two electrodes H Ground Pad Neutral Electrode Used with monopolar electrode configurations only the pad is placed securely on the patient s body in proximity to the site of the...

Page 13: ... E Dashboard Area Displays the electrode information for the selected procedure tab Access this color coded area to edit the electrode setting values of the selected tab F PARALLEL Button Touch to select the parallel bipolar mode to ON or OFF When ON two procedure tabs will merge 1 2 or 3 4 Two parallel bipolar stimulations cannot be performed at one time Each parallel bipolar stimulation must be ...

Page 14: ...TE Touch to delete a file folder or setting value START x2xx START Touch to apply energy to the assigned electrode s The numbers indicate the electrodes that will apply energy Touch the START button in the dashboard area to apply energy STOP STOP ALL Touch to remove energy from active electrode s During lesion creation ALL will appear on the button to indicate the use of more than one electrode BU...

Page 15: ...cable CAUTIONS When connecting or disconnecting any of the two types of cables to the front of the generator always hold the cable by its connector the plug not the cord The locking sleeve is the ridged portion of the connector During removal this ridged portion should be pinched and pulled straight back Cables that are connected to the front of the generator have keyed push pull type connectors t...

Page 16: ...e size and shape of the lesion during its creation NOTE ALWAYS use and properly connect a ground pad to the generator for monopolar electrode configurations The generator will not energize the monopolar electrode if a ground pad is not adequately connected and applied to the patient If a ground pad is not connected or the connection is interrupted an error message will appear on the display 3 Plac...

Page 17: ...0406 900 100 Empty Ground Pad Cable 0406 850 200 7 Empty MultiGen Cable 0406 900 100 Two Concurrent Monopolar 2 MultiGen Cable 0406 900 100 Empty Ground Pad Cable 0406 850 200 7 Empty MultiGen Cable 0406 900 100 Three Concurrent Monopolar 3 MultiGen Cable 0406 900 100 MultiGen Cable 0406 900 100 Ground Pad Cable 0406 850 200 7 and 8 MultiGen Cable 0406 900 100 MultiGen Cable 0406 900 100 Four Conc...

Page 18: ...ee To Perform Initial Setup section 2 See To Connect Electrode Cable s section 3 See To Attach Cable Identification Tags section 4 See To Connect a Ground Pad monopolar only section 5 See To Connect a Printer optional section 6 See To Connect a RF Hand Controller optional section Figure 7 Monopolar or Monopolar and Parallel Bipolar Configuration ...

Page 19: ... either generator port 1 See To Perform Initial Setup section 2 See To Connect Electrode Cable s section 3 See To Attach Cable Identification Tags section 4 See To Connect a Ground Pad monopolar only section 5 See To Connect a Printer optional section 6 See To Connect a RF Hand Controller optional section Figure 8 Monopolar or Monopolar and Parallel Bipolar Combination Configuration ...

Page 20: ...g MultiGen Cable s 1 See To Perform Initial Setup section 2 See To Connect Electrode Cable s section 3 See To Attach Cable Identification Tags section 4 See To Connect a Printer optional section 5 See To Connect a RF Hand Controller optional section Figure 9 Parallel Bipolar Configuration ...

Page 21: ... PROCEDURE button is selected see To Save or Access Saved Procedure Settings section to create edit or select a folder file for a procedure 2 Under the guidance of X ray or fluoroscopic technology place the cannula tip in the target nerve tissue area NOTE Fluoroscopic dye may be injected to facilitate the correct placement of the electrode cannula tip in proximity to the target nerve tissue 3 Remo...

Page 22: ...0v IMPEDANCE AMPLITUDE 200Ω 0 00v IMPEDANCE AMPLITUDE 200Ω 0 00v IMPEDANCE AMPLITUDE 1 2 3 4 PARALLEL PARALLEL START 1xxx FREQUENCY 2 0Hz WIDTH 1 00ms AMPLITUDE 0 00v EDIT EDIT PLACEMENT L2 LEFT EDIT EDIT MOTOR STIM SUMMARY LESION SENSORY MOTOR Figure 12 Typical Stimulation Motor Screen INACTIVE To EDIT Sensory or Motor Stimulation Settings NOTE The sensory and motor stimulation screens have a sim...

Page 23: ...ing is not adjustable after the START button is touched B EDIT WIDTH Button Window Touch to select a preset width Once selected the value is displayed in the window This setting is not adjustable after the START button is touched C EDIT AMPLITUDE Button Window Touch to enter a specific amplitude setting value Once entered the value is displayed in the window This value is adjustable after the STAR...

Page 24: ...tep rate values have been set as required See To EDIT Sensory or Motor Stimulation Settings section 2 If performing a parallel bipolar procedure touch the PARALLEL button see figure 16 3 Touch the START button to apply stimulation energy using the setting values displayed in the procedure tab area The active electrode identifier number will flash and an audible beep will sound to indicate the stim...

Page 25: ... PARALLEL 37C 0S 250Ω w TEMPERATURE TIME IMPEDANCE WATTAGE EDIT 37C 0S 250Ω w TEMPERATURE TIME IMPEDANCE WATTAGE EDIT PARALLEL 4 3 2 1 1 Figure 18 RF Output Screen in THERMAL Mode INACTIVE 48s 0 999 8 5 6 7 4 1 2 3 9 0 CANCEL ENTER EDIT HOLD TIME Figure 19 Typical Keypad Dashboard HOLD TIME A EDIT SET TEMP Button Window Touch to enter a specific set temperature B EDIT HOLD TIME Button Window Touch...

Page 26: ...RF lesion creation inadvertent selection of the THERMAL RF button may result in undesired tissue damage and result in patient injury NOTE THERMAL and PULSE modes of operation may be performed at the same time in separate procedure tabs A EDIT PULSE VALUES Button Window Available in PULSE mode only touch to select a preset value and a PULSE CONTROL option The selected value appears in the window B ...

Page 27: ... value displayed is approximately 37 C body temperature and the impedance value displayed is within a normal range for the procedure Ensure the electrode identifier number corresponds to the desired tagged electrode 3 Touch and confirm the START button to apply RF energy output see figure 22 The electrode identifier number will flash and an audible beep will be heard to indicate the application of...

Page 28: ... value remaining in seconds C IMPEDANCE Tab Value The value displayed in ohms 0 2000 Ω is continuously monitored and represents tissue impedance measured by the electrode s If no electrodes are connected the IMPEDANCE tab value will display If an electrode is connected to any port but the value exceeds its limit the value displayed will be HIGH for all tabs A lesion cannot be created if the impeda...

Page 29: ...fore use The number s will remain depressed to indicate they are selected locked and ready to apply RF energy output see figure 25 4 Touch the START button A START confirmation dashboard will display the number of electrodes that will apply RF energy output Touch the START button on the dashboard to confirm the application of RF energy output 5 The electrode identifier number s of each active elec...

Page 30: ...the actual temperature value displayed is approximately 37 C body temperature and the impedance value displayed is within a normal range for the procedure 5 Touch and confirm the START button to apply RF energy output The electrode tab number will flash on the screen and an audible beep will be heard to indicate the application of RF energy output 6 If the RF energy output must be stopped before t...

Page 31: ...RALLEL PARALLEL Figure 28 Choose Placement Region Dashboard RIGHT LEFT PLACEMENT L3 LEFT S1 S2 S3 S4 S1 S2 L5 L5 L4 L4 L3 L3 L2 L2 L1 L1 S3 S4 CX CX ENTER CANCEL Figure 29 Typical CHOOSE PLACEMENT Dashboard LUMBAR A CHOOSE PLACEMENT REGION Dashboard Touch one of the anatomical region buttons to access a region dashboard B CERVICAL Button Touch to access the cervical region dashboard C THORACIC But...

Page 32: ...ta is also collected if adjustments are made Data collection ends when the procedure ends or the STOP button is touched D Date and Time Window Left Right Arrow Buttons Touch to scroll through and view the date and timestamp information captured during data collection The procedure values associated with each date timestamp will be displayed E MOTOR Summary Window View motor stimulation values coll...

Page 33: ... a new folder or file ENTER CANCEL LUMBAR 1 2 3 4 5 6 7 8 9 0 Q W E R T Y U I O P A S D F G H J K L Z X C V B N M DELETE SHIFT SPACE FILE NAME Figure 31 Typical Keyboard Screen A Title Window Enter a printout folder or file name up to 25 characters in length for example patient name or level treated B SPACE Key Touch to enter a space between characters C SHIFT Key Touch to enter the ampersand and ...

Page 34: ...ed folder B OPEN Button Touch to open a selected folder and access the Select File screen You may touch the selected folder again to open the folder directly C FOLDER Selection Window View all the available folders Touch the folder icon to select it The selected folder is displayed as a blue folder icon D EDIT NAME Button Touch to access a keyboard screen to change the name of a selected folder E ...

Page 35: ...pen a selected file You may touch the selected file again to open it directly C BACK Button Touch to return to the Select Folder screen D FILE Selection Window View all the available files Touch the file icon to select it The selected file is displayed as a blue file icon E EDIT NAME Button Touch to open a keyboard screen to change the name of a selected file F DELETE Button Touch to delete a sele...

Page 36: ...bs If APPLY TO THIS TAB ONLY is selected each tab may be edited individually C EDIT Setting Value Button s Touch to edit the setting values for the sensory motor or lesion procedures D ACCEPT Button Touch to accept the file setting values displayed E CANCEL Button Touch to cancel any changes made to the file setting values F Intradiscal Lesion IDL Button The intradiscal adapter cable and catheter ...

Page 37: ...N A EDIT Button Registered To Window Touch to access a keyboard screen to enter or edit the registration information The window displays the registration information B Information Window Displays generator information related to software hardware and service C FACTORY DEFAULTS Button Touch to remove all user created files and folders in the file management system and reset the generator system def...

Page 38: ...ightness B ADJUST POSITION Button Touch to access the Display Position screen Touch the arrow buttons to adjust the horizontal and vertical position of the display ENTER CANCEL C CALIBRATE TOUCHSCREEN Button Touch to access the touch screen calibration screen Touch the center of the red box once at each unique location as it moves around the screen DO NOT touch the red box more than once at any lo...

Page 39: ... decrease the speaker volume B BEEP ON TOUCH Switch Touch to activate YES or deactivate NO a beep sound when any button except the amplitude adjustment is touched on the screen C BEEP WITH NEW AMPLITUDE Switch Touch to activate YES or deactivate NO a beep sound when the arrow buttons are touched during amplitude adjustment on the active sensory or motor stimulation screens The arrow buttons will r...

Page 40: ...E MONTH Button Window Touch to enter a new month value using the keypad buttons The new value will appear in the window F YEAR Button Window Touch to enter a new year value using the keypad buttons The new value will appear in the window G TIME Window View the time hour minutes seconds currently applied H RANGE Window View the acceptable range for a new value I ACCEPT Button Touch to apply a new v...

Page 41: ...creen touch the LANGUAGE button to access the Language Settings screen see figure 40 In the future the screen language may be changed to one of several languages FACTORY DEFAULTS PROCEDURE DEFAULTS DATE TIME REGISTRATION DISPLAY SOUND English Français Italiano Deutsch Español SELECT LANGUAGE LANGUAGE Figure 40 Language Settings Screen ...

Page 42: ...tabs If APPLY TO THIS TAB ONLY is selected each tab may be edited individually C EDIT Settings Buttons Touch to edit the setting values for the sensory motor or lesion procedures D ACCEPT Button Touch to accept changes to the procedure default setting values E CANCEL Button Touch to cancel any changes made to the procedure default setting values F IDL Button The intradiscal adapter cable and cathe...

Page 43: ... all four procedure tabs two ports The temperature value displayed on the generator and the temperature value of the calibrated temperature measurement device should be within 4 C 2 C from 37 0 C to 95 0 C IMPEDANCE 500 Ohm resistors 1 1 Ensure the generator is in stimulation mode either sensory or motor 2 Carefully connect one side of the resistor to the exposed tip of the cannula electrode 3 Lif...

Page 44: ...nd other operating room equipment into different outlets circuits The system impedance is too high The instrument may be damaged The electrode MultiGen cable connections is are not secure Ensure all connections are secure The electrode is not fully inserted into the cannula Ensure the electrode is fully inserted into the cannula The ground pad cable connection is not secure The ground pad placemen...

Page 45: ...ged Replace the electrode and or MultiGen cable If the error persists contact Stryker customer service A rapid increase in system impedance has been detected The electrode is not fully inserted into the cannula Ensure the electrode is fully inserted into the cannula The electrode placement is not correct Ensure the active tip of the electrode is surrounded by tissue and the tip is not in a blood v...

Page 46: ...Equipment Part 1 General Requirements for Basic Safety and Essential Performance Consolidated Reprint 2009 Amendment 2 2010 INTERNATIONAL ELECTROTECHNICAL COMMISSION IEC IEC 60601 1 2005 Ed 3 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Corrigendum 1 2006 Corrigendum 2 2007 EUROPEAN COMMITTEE FOR ELECTROTECHNICAL STANDARDIZATION CENELEC EN 606...

Page 47: ...Transportation Temperature 30 C 10 C 65 C 34 C Relative Humidity 80 15 Atmospheric Pressure 1 Pulse mode frequency and width tolerances may vary based on the number of active electrodes and their corresponding pulse mode settings Guidance and manufacturer s declaration electromagnetic emissions The RF MultiGen generator REF 0406 900 000 is intended for use in the electromagnetic environment specif...

Page 48: ...onment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 ...

Page 49: ...nvironment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the RF MultiGen generator REF 0406 900 000 is used exceeds the applicable RF compliance level above the RF MultiGen generator REF 0406 900 000 should be observed to be verify normal operation If abnormal performance is observed additional measures may ...

Page 50: ...Controller Instructions Intended Use The RF Hand Controller is designed to be used with the RF Generator REF 0406 800 000 generator and RF MultiGen generator REF 0406 900 000 The hand controller can be used by the circulating assistant or by the surgeon from within the sterile field to control the generator and select basic system functions see figure 44 Features and Functions Figure 44 Hand Contr...

Page 51: ...STIMULATION INACTIVE STIMULATION ACTIVE No function No function Press to STOP sensory or motor stimulation LESION No function Press to START sensory or motor stimulation Press to STOP sensory or motor stimulation STIM Press to begin using the default setting values Press to access the next screen sensory to motor to lesion etc No function NEXT Press to begin using the default setting values Press ...

Page 52: ... No function Press to access and view the next file or folder Press to select the YES button in a pop up requiring a YES NO response INCREASE FAST Press to access the previous procedure tab electrode identifier 1 to electrode identifier 4 to electrode identifier 3 etc No function Press to access and view the previous file or folder Press to select YES button in a pop up requiring a YES NO response...

Page 53: ...s Stimulation Width Graph Figure 46 Maximum Stimulation Width vs Frequency Graph Appendix C Relative Lesion Sizes and Shapes parallel bipolar only NOTES Due to the variability in distance that can arise when placing the electrodes it is important to remember that the distance between the electrodes directly affects the relative shape and size of the resulting lesion Lesion sizes can vary significa...

Page 54: ...ed between the two electrodes For more information see Pino Hoeft et al1 1 Pino CA Hoeft MA Hofsess C Rathmell JP 2005 Morphologic analysis of bipolar radio frequency lesions Implications for treatment of the sacroiliac joint Regional Anesthesia and Pain Medicine Vol 30 No 4 July August 2005 335 338 10 mm Figure 49 Non contiguous Lesions 4 4 mm x 7 5 mm width x length 5 0 mm x 8 2 mm width x lengt...

Page 55: ...urst is output and lasts about 10 microseconds μs 2 a delay of no output occurs and lasts a random amount of time 3 steps 1 and 2 are repeated for six milliseconds The random length delays result in a aperiodic train of bursts Figure 51 DualWave Waveform Appendix E Radio Frequency Output Plot see figure 52 50 45 40 35 30 25 20 15 10 5 0 0 100 200 300 400 500 600 700 800 0 200 400 600 800 1000 Impe...

Page 56: ...isecond Software License Notice The generator contains software that is installed by the Stryker Corporation Stryker Corporation owns this software this software is never sold Each sale of a software containing product is not a sale of such software it includes only a license to use the software in the product in which the software was initially installed Any license granted by Stryker Corporation...

Page 57: ...ufactured for Stryker Instruments 4100 E Milham Kalamazoo Michigan 49001 USA 269 323 7700 800 253 3210 Manufactured by Synergetics Inc 79 Hubble Drive Suite 105 109 Dardenne Prairie MO 63368 USA ES DE FR IT NL PT 0406 900 713 JA ZH KO 0406 900 720 ...

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