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Programming with groups and programs

1. TO WORK IN DEMO MODE button Figure 11 APPLICATION SELECTION and THERAPY DESKTOP screens 18 English 8840 8870 V A 2011 04 Navigating to the Therapy Desktop 1 To insert and eject the application card Insert the application card arrow and bar code side facing up and in the direction of the arrow into the card slot until it is seated Figure 12 Caution To avoid damaging the components do not force the application card into the clinician programmer and do not insert non Medtronic application cards To lock the application card in place pull out the APPLICATION CARD EJECTION key then flip it down and to the side so that it is flush with the opening APPLICATION CARD EJECTION key Figure 12 Inserting the application card To eject the application card reverse the instructions in step 2 then push in the APPLICATION CARD EJECTION key Note Do not remove the application card while the programmer is ON If the application card must be ejected turn the programmer OFF reinsert the card then turn the programmer ON Caution Do not remove the application card while the application is active If the application card is removed while the application is active the session will automatically end and unsaved data will be lost To turn the programmer ON or OFF Slide and momentarily hold the POWER key Figure 1 on page 8 To check programmer battery status View the battery status icon on t
2. 4 To correct settings or make changes access the PROGRAM mySTIM menu f Printing session reports Session reports contain the settings and patient and system information from patient sessions You can print reports during and after patient sessions The following reports can be selected for printing depending on whether data exist for the report Summary report neurostimulator data and history this report is always available as indicated by the check mark by the title Groups report group and program information Measurements report results from the electrode impedance test and group impedance test myStim Diary report group use data since the last session 8840 8870 V A 2011 04 English 77 Working List report information on all programs in the Working List Patient report for the patient information on patient settings available patient limits and Scheduled Therapy MDT Data report data that can be provided to Medtronic Technical Services this report is a separate file in the Session Data Manager All Reports all reports are selected for printing Reports selected to be printed after a patient session are saved as a single report in the Session Data Manager and named with the patient session name You can print saved session reports from the Session Data Manager or print current settings any time during the programming session Session reports are saved to the application card so the appropriate
3. Measurements and diagnostic data obtained from the clinician programmer are intended to aid in your clinical assessment However as with any electronic system internal and external factors can influence neurostimulator measurements For example changes in lead position can affect the stimulation current or the impedance measurement If you obtain a reading that seems inconsistent with your observations repeat the measurement Before using any measurement functions please note the following Measure electrode impedance at the beginning of each programming session These measurements verify the integrity of lead extension connector pathways They may provide information about lead problems eg lead breakage short circuit open circuit For example measurements that show a significant increase in impedance can indicate a fractured lead conductor a loose setscrew etc Conversely a significant decrease in impedance can indicate shorted conductors a break in lead insulation etc Measurements taken at the beginning of the session may be useful in interpreting diagnostic data collected since the previous session Measure group therapy impedance at the end of each programming session These measurements provide documentation the pathways are intact and the current provided is sufficient for the selected therapy To check electrode impedance During the electrode impedance test preset rate and pulse width values are used The preset
4. 4 Access the PROGRAM mySTIM menu f and select Limits Settings Select a group from the group selection drop down list Figure 39 on page 69 Select the appropriate radio button for rate limits Figure 39 If you selected the CUSTOMIZE radio button select the specific values for the limits a Select the entry from the rate input box for the rate The RATE LIMITS screen appears b Select values for the upper limit tracking or custom and lower custom limit 72 English 8840 8870 V A 2011 04 Note The limits are displayed in the information area of the screen c Select the OK button O Hold the programming head steady over the neurostimulator and select the PROGRAM button To enable GroupAdjust If appropriate for the patient the group adjust feature can be enabled to allow the patient to increase or decrease all program amplitudes in the active group at the same time 1 2 3 e oe NS Access the PROGRAM mySTIM menu f and select Limits Settings Select A Z from the group selection drop down list Select the checkbox next to GroupAdjust Figure 39 on page 69 to enable the feature if it is not active Hold the programming head steady over the neurostimulator and select the PROGRAM button To enable TARGETmyStim Access the PROGRAM mySTIM menu Ci and select Limits Settings Select A Z from the group selection drop down list Select the TARGETmySTIM button Figure 39 on page 69 Se
5. 1 Press down and forward on the programming head until it snaps out of the docked position Figure 9 Figure 9 Extending programming head 2 Extend the programming head to the desired position To retract and dock the programming head 1 Turn the cable reel in the direction of the arrow until the programming head rests against the programmer Figure 10 Figure 10 Retracting the programming head 2 Gently push the programming head into place until it snaps into the docked position 8840 8870 V A 2011 04 English 17 Preparing for a programming session Before beginning a programming session insert the appropriate application card turn the programmer ON check the programmer battery status and navigate to the THERAPY DESKTOP screen Figure 11 The following tasks can be initiated from the THERAPY DESKTOP screen Transfer patient information by selecting the UTILITIES tab Work in demo mode by selecting the TO WORK IN DEMO MODE button Interrogate the neurostimulator and begin a programming session by pressing the PROGRAMMING P key UTILITIES tab Neurostimulation Desktop To begin a session NEUROSTIMULATION APPLICATION button Position programming a head over Cc neurostimulator i Press the button x OR Select a Device Caution Tum neurostimulator ON before all parameter adjustments especially amplitude and pulse width SESSION DATA MANAGER button To work in demo mode
6. From the second drop down list on the screen select a program Figure 33 The SCROLL RIGHT SCROLL LEFT buttons provide an alternative method to view and select a program Notes Only programs that have the same lead configuration as the interrogated neurostimulator are available in the drop down lists The settings for the selected program are displayed The rate setting will be the same for all the programs in the group The rate setting may change depending on whether the imported program is the first in the group and on how many programs are in the group 6 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 58 English 8840 8870 V A 2011 04 To save programs to the Working List During a programming session you may wish to save newly created or modified programs to the Working List These programs are saved in the Model 8840 Clinician Programmer and are available for use until the end of the programming session 1 Access the PROGRAM mySTIM menu f and select Program myStim 2 Select and program a group refer to Programming with groups and programs on page 48 3 Select a numbered program tab or an undefined program tab 4 Adjust the parameter settings for that program Note Amplitude value cannot be 0 0 V gi Select the SAVE button to label the new program and save it to the Working List Label
7. RestoreADVANCED SoftStart Stop AutoFill GroupAdjust Optimizer TARGETmyStim TargetStim and SynchroMed are trademarks of Medtronic Inc registered in the U S and other countries Seiko is a registered trademark of Seiko Instruments Inc 2 English 8840 8870 V A 2011 04 Table of contents Description 7 Package contents 7 Introduction 8 Programmer components 8 Printer 9 Navigation status and data entry 10 Navigation and status 10 Programmer status bar 10 Slider bar 11 Title bar 12 Navigation bar 12 Data entry 14 Using the programming head 16 Disconnecting the magnet 16 To disconnect the magnet from the programming head 16 Extending and retracting the programming head 16 To extend the programming head 17 To retract and dock the programming head 17 Preparing for a programming session 18 Navigating to the Therapy Desktop 19 To insert and eject the application card 19 To turn the programmer ON or OFF 19 Refer to the indications sheet for indications and related information Refer to the device implant manual for device description package contents device specifications and instructions for use Refer to System Eligibility Battery Longevity Specifications reference manual packaged with the software application card for neurostimulator selection battery longevity calculations and specific neurostimulator specifications Refer to the Model 8840 N Vision Clinician Programmer user manual for pr
8. and the settings apply to existing and new groups 68 English 8840 8870 V A 2011 04 Checkbox to enable GroupAdjust Limit types TARGETmySTIM button RestoreADVANCED Limits Settings myStim Settings Group Amp limits amp Full Range e Customize amp Off PW limits amp Full Range e Customize amp Off 210 450 us Rate limits Full Range e Customize LU Off M GroupAdjust TARGETmyStim Other Settings M SoftStart Stop M Cycling cars NJK 37713 John Doe A Z limits RestoreADVANCED Limits Settings myStim Settings Group Group selection drop down list Amp limits amp Full Range le Customize Lc Off PW limits 210 300 ps amp Full Range 210 450 ps Customize C Off 210 390 us Input boxes for selecting limit values Rate limits QC Full Range e Customize LU Off 40 80 Hz Other Settings M SoftStart Stop TM Cycling een NJK 37713 John Doe Individual group limits Figure 39 Programming patient control limits If clinician set limits are programmed CUSTOMIZE radio button selected the following options are available Upper limits To set upper limits you may choose one of two programming options Tracking upper limit adjusts with changes made to the stimulation parameter value eg amplitude during a session Custom upper limit fixed regardless of changes made to the stimulation parameter eg ampl
9. verify that the amplitudes are set to 0 0 V before turning on the neurostimulator Table 4 Screening process with the ENS Procedure Do this Go to page Prepare for the screening process 1 Check the programmer e Check replace programmer batteries page 95 Ensure that the application card is properly installed page 19 2 Turn the programmer ON e Turn ON the programmer The APPLICATION page 19 SELECTION screen appears 24 English 8840 8870 V A 2011 04 Table 4 Screening process with the ENS continued Procedure Select the NEUROSTIMULATION APPLICATION button Interrogate the neurostimulator Select the intraoperative screening option Select lead configuration Select lead configuration Check system performance Check electrode impedance if desired Note Perform this procedure at the beginning of the session These measurements verify the integrity of lead extension connector pathways Check group therapy impedance if desired Note Perform this procedure at the end of the session These measurements provide documentation that pathways are intact and the current provided is sufficient for the selected therapy Set stimulation parameters Ensure that the neurostimulator is ON Set electrode polarities Set rate and pulse width Set amplitude resolution and amplitude Do this Go to page The THERAPY DESKTOP screen appears page 18 e Connect the ENS to the programmer page 23
10. 2011 04 English 53 Notes To avoid possible sudden unpleasant stimulation for the patient ensure that the neurostimulator is ON before programming the amplitude Amplitude is automatically programmed when a target value is selected Ramping to the new value begins immediately This differs from pulse width and rate programming which require the clinician to press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen before the new values take effect Amplitude values may also be modified from the group tab see To adjust amplitudes from the group tab on page 50 Access the PROGRAM mySTIM menu f and select Program myStim 1 2 Select and program a group 3 Select a program tab in the selected group 4 Select the amplitude input box Figure 30 RestoreADVANCED Program myStim O RestoreADVANCED Program myStim cd a C aC S 6 Current Programs M Programmed 5 6 all All zl gt 0 0 25 5 0 7 5 10 0 Amplitude values Program label Gand bad mes e g 0 5 30 55 80 10 5 1 0 35 60 85 I 13 40 65 90 E Amplitude input box sa 45 70 i Amplitude resolution values 2 Amplitude resolution E AMPLITUDE TO ZERO button 005 LI EC W F 8 6 E 35 0 0 Hi STOP button Upper limit tracking 3 0 a i 7 Figure 30 Programming amplitude and amplitude resolution Select an amplitude resolution Figure 30 Select the amplitude input box again To set amplitude hold the pro
11. A Select a print report button to move sessions into and out of the print queue A PRINT SHORT REPORT button 20 A h PRINT LONG REPORT button 20 y REMOVE FROM PRINT QUEUE button amp Notes The long report includes all reports selected using the print later option the print short report option includes the summary report only The MDT Data report can be printed with either the short report or long report option To view a report from the Session Data Manager Select the SESSION DATA MANAGER button E from the slider bar Select an individual report Select the VIEW button 3 8840 8870 V A 2011 04 English 79 Managing session data files As long as there is space on the application card a new session data file is generated at the end of each programming session Session data files are stored in the Session Data Manager Approximately 50 sessions can be stored on the programmer The APPLICATION SELECTION screen displays the session data file status when the Model 8840 Clinician Programmer is turned ON Figure 46 on page 80 n Number of sessions saved Percentage of memory used If the percentage of memory used approaches 100 or a message that the Session Data Manager is full appears when the application is launched delete unneeded files Number of files available to print SESSION DATA MANAGER button Percentage of memory used Figure 46 APPLICATION SELECTION screen To delete
12. A neurostimulator safety feature that turns stimulation OFF 98 English 8840 8870 V A 2011 04 Programs A specific combination of amplitude rate and pulse width parameters acting on a specific electrode set that determines the stimulation pulses that are delivered Pulse width The length of time measured in microseconds us that a particular pulse is delivered Rate The number of times per second measured in Hertz Hz that a neurostimulation pulse is delivered Screening Intraoperative testing to determine best paresthesia coverage Session Data Manager Allows collection and storage of patient data information gathered during patient sessions Report data from previous sessions can be viewed and printed SoftStart Stop Allows stimulation to begin with a ramped output to prevent the sensation of a sudden burst of stimulation when the neurostimulator is turned on and gradually decreases the amplitude to 0 0 V when the neurostimulator is turned off Stylus A blunt pen shaped or pencil shaped device used to make contact with a touchscreen on a device such as a computer or programmer TargetmyStim Allows the patient to refine therapy settings by transitioning electrode patterns using interleaved stimulation pulses TargetStim Identifies and refines therapy settings by transitioning electrode patterns using interleaved stimulation pulses Target value Before programming the intended value of a parameter
13. ON recharge etc Review modify stimulation parameters verify that desired program is selected Select a group and a program Review modify electrode polarities Review modify rate and pulse width Access the PROGRAM mySTIM menu and select page 48 Program myStim e Select a group from the group selection drop down list e While holding the programming head steady over the neurostimulator press the PROGRAMMING P key or select the ACTIVATE button on the programmer screen to make the group active Select a program tab Use the stylus to select negative positive or OFF page 51 electrode polarities for the selected lead Turn the SCROLL WHEEL to move electrode polarity assignments up and down on the selected lead s Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen If desired select values for rate and pulse width before programming electrode polarities e Select the rate input box then select a rate page 52 Select the pulse width input box then select a pulse width Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 8840 8870 V A 2011 04 English 33 Table 5 Programming process continued Procedure 4 Review modify amplitude resolution and amplitude 5 Review modify stimu
14. Press the PROGRAMMING key The light on the back of page 82 the programming head will flash green while telemetry is ongoing and will stop flashing when telemetry is finished e If no error messages appear continue If an error message appears see the troubleshooting section e Select Intraoperative from the TESTSTIM SELECTION page 24 screen On the LEAD CONFIGURATION screen configure the page 38 leads to be consistent with the patient s lead setup e Access the MEASUREMENT menu and select Electrode page 42 Impedance Select the desired amplitude from the drop down list e Select the MEASUREMENT button e Select the OK button to perform the test Review electrode impedance measurement results Note This procedure takes approximately 1 minute In order to perform measurements this procedure temporarily reprograms the stimulation settings e Access the MEASUREMENT menu and select Group page 44 Impedance Select the MEASUREMENT button e Select the OK button to perform the test Review impedance and stimulation current data Note This measurement is available only when a program has been defined e If the neurostimulator is OFF select the page 42 NEUROSTIMULATOR ON OFF button Access the PROGRAM mySTIM menu and select page 51 Program myStim e Use the stylus to select negative positive or OFF electrode polarities for the selected lead s Turn the scroll wheel to move electrode polarity ass
15. Telemetry Radio frequency communication between a clinician programmer and an implanted neurostimulator Test stimulation A postoperative multiday trial period of a patient s reaction to stimulation using an external neurostimulator and implanted leads Tracking limit Patient control limits that automatically remain at the specified value above the clinician programmed value Tracking limits change when the programmed value is changed with the clinician programmer 8840 8870 V A 2011 04 English 99 100 English 8840 8870 V A 2011 04 8840 8870 V A 2011 04 English 101 102 English 8840 8870 V A 2011 04 Contacts Asia Medtronic International Ltd Tel 02891 4068 Fax 02591 0313 Medtronic Asia Ltd Tel 02 548 1148 Fax 02 518 4786 Australia Medtronic Australasia Pty Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel 61 2 9857 9000 Fax 61 2 9878 5100 Toll free 1 800 668 6700 Austria Medtronic Osterreich GmbH Tel 01 240440 Fax 01 24044 100 Belgium Medtronic Belgium S A Tel 02 456 0900 Fax 02 460 2667 Canada Medtronic of Canada Ltd Tel 1 905 460 3800 Fax 1905 826 6620 Czech Republic Medtronic Czechia s r o Tel 2 965 795 80 Fax 2 965 795 89 Denmark Medtronic Danmark A S Tel 45 32 48 18 00 Fax 45 32 48 18 01 Finland Medtronic Finland Oy LTD Tel 09 755 2500 Fax 09 755 25018 France Medtronic France S A S Tel 01 5538 1700 Fax 01 5538 1800 Germany M
16. application card must be inserted into the programmer 1 e e wn da i N To print a report during the session Ensure the printer is ON Access the END SESSION menu gt and select Print Reports Select the checkbox in the Now column next to the reports on the list Move the programmer to within 1 meter 3 3 ft of the printer with the printer and programmer IR ports directly facing each other Select the PRINT button _ To print a report after the session Ensure that the printer is ON Access the END SESSION menu acy and select Print Reports Select the checkbox in the Later column next to the reports on the list Move the programmer to within 1 meter 3 3 ft of the printer with the printer and programmer IR ports directly facing each other Select the SESSION DATA MANAGER button a from the slider bar The SESSION DATA MANAGER screen appears Figure 45 78 English 8840 8870 V A 2011 04 rr E _ bene j amn Print queue N SELECT DESELECT ALL REPORTS button 2006 03 08 John Doe REF PRINT SHORT REPORT button L Ei mer REMOVE FROM PRINT QUEUE button CnEenet 2006 03 08 John Doe RES 2006 03 08 John Doe R SELECT DESELECT ALL REPORTS button Selected sessions PRINT LONG REPORT button Figure 45 SESSION DATA MANAGER screen Select an individual report to print by highlighting the report or print all reports by selecting the SELECT DESELECT ALL REPORTS button
17. desired refine stimulation e Access the PROGRAM mySTIM menu and select page 62 parameters using Optimizer Program myStim Select a numbered program tab in the active group e Select the OPTIMIZER button e Select an optimization from the drop down list e Press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen e Select the OK button Complete the screening process 1 Exit application e Access the END SESSION menu and select Exit page 81 e View or print the temporary session report in the Session page 77 Data Manager Pain Test Stim postoperative test stimulation new and follow Up To use the programmer for a new test stimulation session Note Put new batteries in the ENS prior to each new test stimulation See the ENS technical manual for instructions on changing the batteries 1 Select New from the TESTSTIM SELECTION screen refer to Figure 15 on page 24 2 Follow the instructions given in this manual for programming the neurostimulator Refer to Table 5 on page 32 for basic programming steps Use the reference page numbers listed on the table to find additional information in other sections of the manual To use the programmer for a follow up test stimulation session Select Follow up from the TESTSTIM SELECTION screen refer to Figure 15 on page 24 da 26 English 8840 8870 V A 2011 04 2 Follow the instructions given in this manual for programming the neurostimulator Refer
18. during a programming session may cause unsaved data to be lost If the programmer will not be used for several weeks remove the AA batteries from the programmer Batteries left in the programmer may corrode causing damage to the electronic components To replace the programmer batteries Ensure that the appropriate application card is in place Exit the application if necessary Turn the programmer OFF I Press down lightly on the battery compartment cover and push the cover in the direction of the arrow then rotate the cover upwards Figure 51 on page 95 Figure 51 Removing the battery compartment cover 5 Replace all 4 AA batteries Do not use rechargeable batteries Correct battery polarity is indicated inside the battery compartment 6 Replace the battery compartment cover by sliding the cover until it snaps into place 8840 8870 V A 2011 04 English 95 Turn the programmer ON If the programmer does not turn ON verify that the batteries have been installed with the correct polarity Note Dispose of depleted batteries in accordance with local regulations To replace the lithium back up battery 1 Remove the AA programmer batteries 2 Remove the lithium battery from the compartment located inside the AA battery compartment 3 Insert a new lithium battery BR1225 standard lithium coin cell 4 Replace the AA batteries Notes After replacing the lithium back up battery you need to reset the Loc
19. patient session files Select the SESSION DATA MANAGER button Figure 46 from the APPLICATION SELECTION screen or the slider bar Figure 4 on page 11 CI 2 Selecta patient session or sessions 3 Select the DELETE button 1 80 English 8840 8870 V A 2011 04 4 Select the DELETE button L again Printing the screen You can print the current screen displayed on the programmer and send the image to a printer To print the current screen 1 Ensure the printer is ON 2 Access the END SESSION menu gt and select Print Screen 3 Move the programmer to within 1 meter 3 3 ft of the printer with the printer and programmer IR ports directly facing each other Ending the current patient session You can end the current patient session without exiting the application entirely When you end the current patient session the session settings are saved to a session data file and can no longer be updated To end the current patient session 1 Access the END SESSION menu gt and select End Session 2 Select the END PATIENT SESSION button gt 3 Select the OK button O Exiting the application When you exit the application the session settings are saved to a session data file Session data files are saved in the Session Data Manager and named with the session name To exit the application 1 Access the END SESSION menu gt and select Exit 2 Select the OK button Ph 8840 8870 V A 2011 04 Eng
20. programmer Check the ENS clock to ensure it is accurate myStim Diary data may appear offset because of the change Check INS clock The time difference between the INS clock and the clinician programmer clock is greater than one hour Check the INS clock setting to ensure it is set properly INS clock has changed The patient has changed the INS clock using the patient programmer Check the INS clock to ensure it is accurate myStim Diary data may appear offset because of the change Recharge soon The INS battery charge level is low and therapy will not be available soon Charge the neurostimulator battery RestoreADVANCED INS INS is at EOS The INS has reached end of service EOS and therapy is not available Replace the device INS is at ERI The RestoreADVANCED INS is within 6 months of its scheduled end of service The PrimeADVANCED INS is within weeks of its scheduled end of service Replace the device before the end of service is reached Refer to the System Eligibility Battery Longevity and Specifications Neurostimulation Systems for Pain reference manual Charge sooner Since the last physician session the INS batteries were depleted at least once to a low enough level that stimulation was disabled between rechargings RestoreADVANCED INS Charge daily The INS needs to be recharged at least once a day to provide 24 hour stimulation This may be due to high parameter settings or reduced battery capacity Parameter adju
21. settings or reduce the number of electrodes The neurostimulator has undergone a power on reset No therapy is available until the device is re activated The patient programmer can be used to re activate the neurostimulator up to 8 times between clinician sessions After 8 times the clinician programmer must be used to re activate the neurostimulator The RestoreADVANCED INS battery was overcharged or the wrong batteries were placed in the ENS The patient must come into the clinic and the clinician programmer must be used to determine device status Invalid settings were detected in the INS ENS The device must be reset and valid settings entered Invalid settings were detected in the patient programmer The patient should remove the programmer batteries and re insert them after a few seconds The error code should disappear If it reappears the patient programmer may need to be replaced 8840 8870 V A 2011 04 System and programmer settings This section covers the programmer and operating system settings that can be changed by the user Setting localization options The LOCALIZATION screen allows you to change the language date time and decimal format Note The first time the programmer is turned ON or after the lithium backup battery is replaced the LOCALIZATION screen does not allow you to change the language selection To change the language selection reenter the LOCALIZATION screen through the slider bar T
22. the new program a Select a percentage rating indicating the effectiveness of the program according to the patient from the rating list box b Select the body location that the program is stimulating or the activity being done from the drop down list c Select the bilateral spread checkbox and set the percentage rating for bilateral stimulation Use the SCROLL LEFT or SCROLL RIGHT buttons or the selection bar to select the appropriate values 7 Hold the programming head steady over the neurostimulator then select the OK button to save the newly labeled program to the Working List Programming using TargetStim and Optimizer TargetStim and Optimizer provide optional advanced methods of adding programs to groups and refining stimulation settings TargetStim transitions electrode patterns by using interleaved pulses and ramping amplitude to locate effective therapy lt can be used to quickly identify and refine therapy settings during intraoperative test stimulation or it can be used to refine therapy settings during follow up sessions Optimizer can be used to quickly refine programs using variations of the initial program electrode settings Tocreate modify programs using TargetStim TargetStim is available for groups and programs that meet the following criteria The electrode pattern for the program must be able to move up and down the lead There must be at least 1 undefined program The group pulse width
23. to Table 5 on page 32 for basic programming steps Use the reference page numbers listed on the table to find additional information in other sections of the manual 8840 8870 V A 2011 04 English 27 Programming the neurostimulator Programming the neurostimulator involves reviewing and modifying the information settings and optional features that are programmed in the neurostimulator Information and settings may have been programmed in an earlier session or may be the default parameters that were set during manufacturing Note The screens presented in this manual are representative of specific Medtronic neurostimulator applications Features represented may not be available with all external neurostimulator models during test stimulation or with all implantable neurostimulator models during programming During a programming session telemetry transfers and retrieves data to and from the neurostimulator The data transferred and retrieved include the following Stimulation parameters Electrode polarities Programmed positive negative or OFF Pulse width Duration of each pulse in microseconds us The patient experiences pulse width as the strength or coverage of the paresthesia Rate Frequency of pulses in Hertz Hz The patient experiences rate as the smoothness of the paresthesia Amplitude Strength of pulse in volts V The patient experiences amplitude as the strength or coverage of the paresthe
24. 11 04 Table 1 Programmer status bar icon descriptions Nontelemetry communication port Nontelemetry Printer ca Printing Programming head Programming head present G Communication active established between programming head and device Magnet present on programming head fhag Demo mode LS Demo mode is active Programmer battery High battery status Low battery status Slider bar communication is Nontelemetry communication is inactive Printing error gt Printing i inactive Programming head not present No Gi communication between programming head and device Magnet present Magnet Kad telemetry Kua present successful tt telemetry not successful Medium battery status Depleted battery status blinking The slider bar provides access to programmer information operating system and touchscreen display settings and printer and calculator functions The slider bar can be accessed any time during a programming session by selecting the SLIDER BAR button on the programmer status bar Figure 4 2006 03 17 ff F RQ LL SLIDER BAR button _ lo9 26 ft i RestoreADVANCED Start Session Figure 4 SLIDER BAR button 8840 8870 V A 2011 04 English 11 Table 2 SLIDER BAR button descriptions Button Description INFORMATION Display the names model numbers and version Le numbers for programmer application and associate
25. Access the MEASUREMENT menu and select Battery page 46 Longevity e Select a group from the group selection drop down list Select the MEASUREMENT button The following parameters and features are optional and are designed to increase patient comfort and ease of use as well as extend neurostimulator battery life and the interval between battery recharges INS only If desired review modify SoftStart Stop If desired review modify Cycling Review modify patient control limits If desired review modify GroupAdijust Access the PROGRAM mySTIM menu and select Limits page 67 Settings e Select a group from the group selection drop down list e If needed select the checkbox next to SoftStart Stop to turn the feature ON e Select the SoftStart Stop input box e Select a value e Select the OK button e Hold the programming head steady over the neurostimulator and program the SoftStart Stop value e Access the PROGRAM mySTIM menu and select Limits page 67 Settings e Select a group from the group selection drop down list If needed select the checkbox to turn the feature ON e Select the Cycling input box e Select Cycling ON and OFF Time values e Select the OK button Hold the programming head steady over the neurostimulator and program the Cycling values e Access the PROGRAM mySTIM menu and select Limits page 67 Settings From the group selection drop down list select a letter for a single grou
26. Access the PROGRAM mySTIM menu f and select Program myStim Select and program a group Select a program tab in the selected group Select the pulse width input box or the rate input box Figure 29 Restore ADVANCED Program myStim Fe_alC 0 0 0 0 Current Programs v Ali z gt Program label C1 Lower Back Upper Leg Pulse width input box a fo Ul a WN Rate input box Figure 29 Programming pulse width or rate on a program tab Select a target value from the list of values that appears in the value window The actual and target values appear in the input box with an arrow pointing from the actual value to the target value Note Some values may not be available due to high output interlocks or shared electrodes page 29 If desired fine tune the target value by turning the scroll wheel to increase or decrease the target Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen To review modify amplitude resolution and amplitude Amplitude is the strength of the pulse in volts The patient experiences amplitude as the strength or coverage of the paresthesia Amplitude resolution is the size of the incremental or decremental steps during the time that the amplitude is ramping increasing or decreasing and when the patient adjusts the amplitude setting with the patient programmer 8840 8870 V A
27. D AutoFill E a2 T B Generate Groups from Group selection drop down list Degree of Difference Degree of difference H C same C similar C different Number of Groups to Generate Select Number Number of groups to generate gt a veteran 37713 John Doe Figure 32 Creating new defined groups using AutoFill Select the starting group from the group selection drop down list Figure 32 Select the degree of difference for the electrode patterns rate and pulse width are unchanged Figure 32 The following options are available same The generated group s will be identical to the starting group 56 English 8840 8870 V A 2011 04 similar The generated group s will be created using the Optimizer algorithm to provide new electrode patterns different The generated group s will be created using the Optimizer algorithm to provide new electrode patterns Selecting this option generally provides the highest degree of difference in electrode patterns 4 Select the number of groups to generate using the drop down list Figure 32 Note The number of new groups that can be generated may vary based on the number of programs currently programmed A maximum of 32 programs are available between all groups 5 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 6 Review the informa
28. D Program myStim Program not stimulating amplitude is 0 0 V Lower Back Jv gt 240 us 50Hz e R Program stimulating Foot Js 450 us 50Hz AMPLITUDE ADJUSTMENT buttons Leg lt a 330 ps 50 Hz Figure 27 Adjusting amplitude on the PROGRAM mySTIM screen group tab selected 50 English 8840 8870 V A 2011 04 Reviewing modifying stimulation parameters Reviewing and modifying the stimulation parameters includes programming the electrode polarities pulse width amplitude resolution and amplitude for each program in a group Rate is programmed for all programs in a group Caution To prevent possible uncomfortable or unexpected stimulation jolting or shocking sensation when stimulation is turned on program parameter changes in small increments above the perception threshold the amplitude at which the patient first perceives paresthesia Selecting and programming groups and programs Refer to Programming with groups and programs on page 48 when selecting groups and programs to review modify Using the scroll wheel for programming If desired the scroll wheel on the clinician programmer can be used to make fine adjustments when programming stimulation parameters When a stimulation parameter value is selected with the stylus the SCROLL WHEEL icon 4 appears next to the selected parameter indicating the value can be adjusted by the scroll wheel See further instructions for using the scro
29. Display name of current patient session Display active and available groups Display group optional settings End patient session e Print a variety of session reports e Exit application e Print screen Data entry Enter data into the programmer through the touchscreen display Most data are accepted through the following Drop down list Select the arrow on the right side of a drop down list Select a value or entry 30 Setting input box A selection of values appears when the stylus contacts a setting input box Select a value Keyboard The keyboard appears when the stylus contacts an input box that requires alphanumeric input To enter data select each character Four keyboards are available Figure 7 14 English 8840 8870 V A 2011 04 Close keyboard Enter Backspace International character keyboard Special character keyboard spacebaf Figure 7 Programmer keyboards Alternate keyboards are available by selecting the following buttons STRAIGHT ARROW Uppercase alpha and international characters CIRCULAR ARROW EJ International and special characters 8840 8870 V A 2011 04 English 15 Using the programming head After entering data into the clinician programmer use the programming head to send the data to the device via telemetry Disconnecting the magnet The magnet must be removed from the programming head before using it with any device except SynchroMed and SynchroMe
30. Elective Replacement Indicator ERI Notification that the INS is nearing end of service Electrode impedance measurements Measurements of the resistance of the lead s extension s and body tissue that can provide information about the condition of the implanted system eg short circuit open circuit Electrode polarity State of each electrode for all implanted leads positive negative or off End of Service EOS Condition of an implantable device at the time it is no longer able to operate successfully Final settings Settings in effect at the end of the patient session Group Collection of programs that work together for a particular effect or area GroupAdjust Allows patients to use their patient programmer to increase or decrease all program amplitudes for the active group at the same time Group therapy impedance measurements Impedance and stimulation current measurements taken at the programmed settings Initial settings Settings in effect at the start of the patient session Input box An area on the programmer touchscreen that when activated initiates the appearance of another screen or an action by the programmer Lead configuration The number of leads and electrodes Localization parameters Options for selecting country specific formats for date time numbering schemes and language Optimizer Refines programs using variations of the initial program electrode settings Power on reset
31. For more information on programming a new group see Adding groups and programs on page 55 To activate a group and select a program 1 Access the PROGRAM mySTIM menu f and select Program myStim 2 Select a group from the group selection drop down list Figure 26 48 English 8840 8870 V A 2011 04 RestoreADVANCED wal myStim Group selection drop down list Undefined program tab Program tabs in active group Active group tab Jev 240 ps 50Hz Vv 23 0 8 Foot asv 450 ys 50Hz Lower Leg Gao 330 ps 50 Hz I ACTIVATE button NJK 37713 John Doe Figure 26 PROGRAM mySTIM screen To activate the group hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the ACTIVATE button on the programmer screen Select a numbered program tab to modify settings for a program or select an undefined program tab in the group to create a new program see Adding groups and programs on page 55 Select the group tab to return to the active group settings or to select a new group Note To create or modify programs using stored programs refer to Adding modifying programs using stored programs on page 57 Reviewing group settings during programming You can review stimulation parameter settings for all programs in a group on the PROGRAM mySTIM screen group tab selected at any time during programming The settings on the PROGRAM mySTIM scre
32. ID fields AE Patient Diagnosis Patient diagnosis drop down list Physician Information gt Notes Physician information fields Notes field Patient session name NJK 37713 John Doe Figure 17 PATIENT DATA screen 2 Enter patient name ID number or any other appropriate information in the patient ID fields Figure 17 Note The patient session name includes the information from the first patient ID field The patient session name will appear at the bottom of every screen and on session reports Select a patient diagnosis from the drop down list or enter another diagnosis Figure 17 Enter physician name and phone number or any other appropriate information in the physician information fields and notes field Figure 17 5 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen Entering device information Note Changing the lead configuration or numbering will delete all groups and programs associated with the current lead configuration 8840 8870 V A 2011 04 English 37 To program lead configuration 1 Access the PROFILE menu Ge and select Lead Configuration RestoreADVANCED Lead Configuration Lead configuration drop down list Lead name fields Electrode numbering drop down lists 0 1 2 3 4 5 6 7 FLIP LEADS VERTICALLY button NJK 37713 John Doe Figure 18 LEAD C
33. MMING key P or use the stylus to select anywhere in the To Begin a Session box If the programming head is extended a status light is visible on the back of the programming head Green light flashing Telemetry is successful Amber light flashing Telemetry is unsuccessful An error message appears on the screen see the appropriate Telemetry Failure message in Table 9 on page 85 for more information English 8840 8870 V A 2011 04 Programming for intraoperative screening and postoperative test stimulation To program for intraoperative screening or postoperative test stimulation the Model 37021 or Model 37022 External Neurostimulator ENS is connected to the Model 8840 Clinician Programmer The Model 8870 Application Card provides the software to program the ENS for these procedures Note The screens presented in this manual are representative of specific Medtronic neurostimulator applications Features represented may not be available with all external neurostimulator models during test stimulation or with all implantable neurostimulator models during programming ENS preparation Refer to the ENS user manual for instructions for connecting disconnecting the ENS to the Model 8840 Clinician Programmer connecting the snap lid connector cable to the ENS changing ENS batteries Note Put new batteries in the ENS prior to each new test stimulation Refer to the lead implant manual for instructions for co
34. ONFIGURATION screen 2 Select the appropriate lead configuration from the lead configuration drop down list Figure 18 Note Configurations in the drop down list with parentheses around them represent surgical leads A forward slash indicates the leads are separated in the body and it may not be possible to program them together using the TargetStim feature If appropriate enter lead names in the lead name fields Figure 18 4 lf appropriate renumber the electrodes using the electrode numbering drop down list if lead connection to the neurostimulator is different than pictured 5 If appropriate select the FLIP LEADS VERTICALLY button if lead orientation is different than pictured The electrodes may also be renumbered from this screen Figure 18 6 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen To enter lead model number 1 Access the PROFILE menu and select Lead Data 2 Enter lead model numbers in the lead model number fields 38 English 8840 8870 V A 2011 04 Select the YES button if an extension was used View the lead orientation and configuration on the screen Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen To enter neurostimulator information Access the PROFILE menu and select Dev
35. Physician Recharge Mode RestoreADVANCED Neurostimulator If the patient allows the implanted neurostimulator to overdischarge telemetry is no longer available from the neurostimulator The patient will not be able to charge the neurostimulator battery using the charging system The patient must return to the clinic and the physician must charge the neurostimulator battery using the Physician Recharge Mode on the recharger Typically the neurostimulator will return to normal charging mode in less than 60 minutes If it does not the process should be repeated If the neurostimulator cannot be charged it must be replaced Notes Ifthe battery is successfully recharged it regains functionality but may require more frequent charging sessions by the patient The neurostimulator battery can be restored with the Physician Recharge Mode only twice If the battery is allowed to overdischarge a third time the neurostimulator will reach end of service To perform a physician charging session Palpate the patient s skin to determine the best location for the charging antenna and place the antenna over the neurostimulator 2 Simultaneously press and hold down the START key and AUDIO key located on the front of the recharger Figure 47 for 10 seconds A screen with a 60 minute timer will appear and charging begins da 84 English 8840 8870 V A 2011 04 START key _ AUDIO key E Figure 47 Recharger 3 Continue c
36. REMENT button Figure 22 5 Select the OK button 2h and maintain the position of the programming head over the neurostimulator for the duration of the test Note To stop the group impedance test do one of the following Select the CANCEL button Push the red THERAPY STOP key to turn the neurostimulator OFF 6 Review the group impedance test results Note Test results can be viewed at any time during the programming session by returning to the GROUP IMPEDANCE screen To check neurostimulator battery information At initial interrogation the neurostimulator battery level status RestoreADVANCED INS and service life on the BATTERY screen are updated with the latest test results 1 Access the MEASUREMENT menu P and select Battery RestoreADYANCED PrimeADVANCED Battery Battery DE t D Neurostimulator Neurostimulator Battery Service life Service life Recharge Number Typical duration hrs Typical interval days Typical coupling tit ie Charge Details percorre oe 2004 09 08 Duration hrs 4 2 charge at end 100 37713 John Doe BEL Sannan 37702 John Doe RestoreADVANCED PrimeADVANCED Figure 23 BATTERY screen 8840 8870 V A 2011 04 English 45 Check the battery level status icon Figure 23 RestoreADVANCED INS The icon displayed indicates the battery level status at 100 Cem 75 50 SB 25 or 0 B Review the implant
37. RestoreADVANCED INS Due to a carryover effect the patient may continue to experience symptom suppression during the Cycling OFF time 1 Access the PROGRAM mySTIM menu f and select Limits Settings 2 To program Cycling for a specific group select a group from the group selection drop down list or select A Z to program Cycling for all existing and new groups Figure 38 on page 66 3 Select the checkbox next to Cycling to enable the feature if it is not active Note To disable Cycling deselect the checkbox and go to step 6 Select the Cycling input box Figure 38 on page 66 Use the selection bar or arrow buttons to select the Cycling ON TIME and the Cycling OFF TIME then select the OK button O 6 Holdthe programming head steady over the neurostimulator 7 Select the PROGRAM button Programming a neurostimulator for patient control Patient control limits for amplitude pulse width and rate are set by the clinician and programmed to the neurostimulator before the patient leaves the clinic The patient uses a patient programmer to adjust the stimulation parameter values within the clinician set limits If appropriate for the patient the group adjust feature GroupAdjust can be enabled to allow the patient to increase or decrease all program amplitudes in the active group at the same time Also if appropriate for the patient TARGETmyStim can be enabled to allow the patient to move stimulation settings from elec
38. a gt Medtronic N VISION CLINICIAN PROGRAMMER 8840 with SOFTWARE 8870 RestoreADVANCED and PrimeADVANCED neurostimulation systems for pain 09 07 Programmer guide for software version A _ S gt S gt E a ll mm ee Rx only C 2006 0123 Explanation of symbols on product and package labeling for non USA audiences gp E TO no C ep gt rN gt mE h N C9 N gt B AS TEON Serial number Caution Consult instructions for use Temperature limitation For USA audiences only Non ionizing electromagnetic radiation IEC 60601 1 EN60601 1 Type BF Equipment Conformit Europ enne European Conformity This symbol means that the device fully complies with AIMD Directive 90 385 EEC NB 0123 and R amp TTE Directive 1999 5 EC System meets the applicable Canadian CAN CSA C22 2 No 60601 1 electrical safety standard requirements Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling medtronic com for instructions on proper disposal of this product Chinese Standard SJ T11364 2006 Logo Electronic Information Products Pollution Control Symbol The date in this logo means the environmental protection use period of the product Manufacturer Authorized representative in the European community 8840 8870 V A 2011 04 English 1 Medtronic myStim N Vision PrimeADVANCED
39. ace batteries now BATTERY WARNING Neurostimulator batteries are depleted Replace batteries now Exit application BATTERY WARNING Neurostimulator battery is discharged Exit application BATTERY WARNING Neurostimulator battery is discharged Charge battery now Exit application CONFIGURATION CHANGE All groups and programs associated with current configuration will be deleted Press OK to change configuration DELETE GROUP Select OK to delete this group DELETE PROGRAM Select OK to delete this program DELETE EVENT Select OK to delete this event from schedule DEVICE NOT SUPPORTED 86 English 8840 8870 V A 2011 04 Explanation will end and unsaved data will be lost Reinserting the card will start a new session There is a problem with the application card and it cannot be used A new card must be obtained before a session can be started There is a problem with the application An unrecoverable software error has occurred Contact Medtronic with the service code The programmer batteries are low and may not last an entire programming session Replace the batteries before starting a session The ENS batteries must be replaced now for the ENS to function properly Therapy from the neurostimulator is no longer available PrimeADVANCED INS Neurostimulator battery must be charged now Therapy from the neurostimulator is no longer available RestoreADVANCED INS Changing lead configura
40. alization parameters For instructions see Setting localization options on page 93 Dispose of depleted batteries in accordance with local regulations Return nonfunctioning devices to Medtronic for disposal Cleaning the programmer a To clean the programmer Clean the exterior surfaces of the programming head IR lens and magnet with a damp sponge or soft cloth moistened with water mild detergent or alcohol Be careful to not allow liquid into any programmer components When programming in a sterile field if the programming head comes in contact with a patient s skin wipe the programming head with an antibacterial solution Clean the touchscreen only with a soft dry lint free cloth Do not use cleansers on the touchscreen Caution Scratches on the touchscreen may interfere with selecting an option If the touchscreen is not responding appropriately return the programmer to Medtronic for repair or replacement Calibrating the touchscreen The touchscreen may require periodic calibration When calibrating the touchscreen the programmer compares the points of contact with known locations If the calibration fails the programmer restarts the calibration procedure until the procedure is successfully completed 96 English 8840 8870 V A 2011 04 N VISION CALIBRATE button Figure 52 Calibrating the display To calibrate the touchscreen To begin calibration do one of the following Press and ho
41. ancel pending values by selecting the CANCEL button Bh or the CLEAR PENDING button 8840 8870 V A 2011 04 English 31 Basic programming steps Table 5 presents an overview of the basic steps for a typical follow up programming session The steps apply for both the implantable neurostimulator INS and the external neurostimulator ENS Note The clinician programmer and the installed application card do not program any devices other than associated Medtronic neurostimulators and pumps If an attempt is made to program an incompatible device an error message appears on the programmer Table 5 Programming process Procedure Prepare for the programming session 1 Check the programmer 2 Turn the programmer ON 3 Select the NEUROSTIMULATION APPLICATION button Review initial programming 1 Interrogate the neurostimulator 2 If this is anew patient or if components have been changed enter patient and component information and configure leads 3 Review patient use data and neurostimulation system information 4 Ensure that the neurostimulator is ON Check system performance 1 Check neurostimulator battery information Do this Go to page e Check replace programmer batteries page 95 Ensure that the application card is properly installed page 19 e Turn ON the programmer The APPLICATION page 19 SELECTION screen appears The THERAPY DESKTOP screen appears page 19 Hold the programmi
42. box to turn the feature ON Drag an event block to the 24 hour calendar On the EVENT DETAILS screen select a group to define the new event and adjust the start and stop times for the event e Select the OK button e Create additional scheduled therapy events or update events as desired e Hold the programming head steady over the neurostimulator and program the events e Access the END SESSION menu and select End page 76 Session page 49 Access the PROGRAM mySTIM menu and select Program myStim to review the detailed programmed settings Ensure that the printer is ON page e Access the END SESSION menu and select Print Reports e Select the desired reports e Select the PRINT button e Access the END SESSION menu and select Exit page 81 Note To end the patient session without exiting the application access the END SESSION menu and select End Session then select the END PATIENT SESSION button gt gt e Select the OK button Entering patient and physician information The programmer provides two fields for patient information a drop down list for patient diagnosis two fields for physician information and a field for neurostimulator physician notes The patient and physician information is stored in the 36 English 8840 8870 V A 2011 04 To enter patient information 1 Access the PROFILE menu ie and select Patient Data RestoreADVANCED Patient Data CE 3 4 D Patient ID Patient
43. d Move away from sources of possible EMI eg computer monitors Impedance and stimulation current measurements Electrode impedance and stimulation current are electrical values that can be measured by the neurostimulator and interrogated with the programmer see Checking system performance on page 42 The values listed below may help to further define the system problem For an open circuit broken wire loose connection highly resistive tissue check for impedance as follows At0 25 V gt 4000 ohms At0 7 V gt 10000 ohms At1 5 V gt 20000 ohms At3 0V gt 40000 ohms For a short circuit crossed wires significant stimulation current check for impedance as follows At 0 25 V lt 50 ohms At0O 7 V lt 50 ohms At1 5 V lt 50 ohms At 3 0 V lt 150 ohms Reading serial numbers 1 2 To read the neurostimulator serial number Interrogate the neurostimulator Read the neurostimulator serial number from the bottom of any of the programmer screens To read the clinician programmer serial number Do one of the following Remove the battery compartment cover and batteries see Changing the programmer batteries on page 95 The clinician programmer serial number is located inside the battery compartment 8840 8870 V A 2011 04 English 83 Select the INFORMATION button from the slider bar The clinician programmer serial number is located next to the programmer icon
44. d EL pumps Caution The Model 8529 Magnet is for use with Medtronic SynchroMed and SynchroMed EL Pumps only Remove the magnet from the Model 8840 Clinician Programmer before approaching a patient with a different pump a neurostimulator or another active implanted medical device eg pacemaker defibrillator If the magnet is too close to another active device the therapy of the other device may change To disconnect the magnet from the programming head 1 Unlock the magnet from the programming head by turning the magnet Figure 8 2 Store the magnet in the programmer carrying case qe Figure 8 Unlocking the magnet from the programming head Caution Do not place the magnet on or near computer monitors magnetic storage disks or tapes televisions credit cards or other items affected by strong magnetic fields If the magnet is too close to these items they may be damaged Extending and retracting the programming head The programming head can be used while it is docked on the programmer or extended from the programmer Caution To prevent the cable or electrical contact from being damaged which could prevent further programming and cause unsaved data to be lost do not use excessive force when extending the programming head 16 English 8840 8870 V A 2011 04 do not tangle the cable during extension or retraction do not turn the cable reel counterclockwise To extend the programming head
45. d but not stimulating amplitude is 0 0 V or undefined See Programming with groups and programs on page 48 for more information High output interlocks and shared electrodes High output interlocks Certain combinations of high amplitude pulse width and rate settings are not allowed by the clinician programmer High output interlocks can prevent certain values and features from being available for programming If you attempt to program a parameter value or limit that will cause the settings to exceed the high output interlock limit the desired parameter value can only be achieved by reducing one of the other parameter values Shared electrodes One electrode may be active in more than one program within a group When more than one electrode is shared by more than one program certain restrictions are applied to prevent group rate and pulse width upper limits from exceeding 260 Hz for rate or 450 us for pulse width Group rate is calculated by multiplying the rate by the number of programs in that group Group pulse width is the highest pulse width among all programs in that group 8840 8870 V A 2011 04 English 29 Programming warnings and cautions A Warning When a patient s medical condition requires both a neurostimulator and an implanted cardiac device eg pacemaker defibrillator physicians involved with both devices eg neurologist neurosurgeon cardiologist cardiac surgeon should discuss the possible interactions between t
46. d software and peripheral devices i SETTINGS e Adjust the display contrast e Adjust the speaker volume e Adjust the key click sound e Calibrate the touchscreen pa LOCALIZATION Select the language preference e Select the date format and set the date e Select the decimal format e Set the time format SESSION DATA Print session reports G MANAGER e View session reports Delete session reports CALCULATOR e Access the calculator Q EXIT e Return to the APPLICATION SELECTION APPLICATION screen to select a new application Title bar The title bar displays the application name and active programmer screen The title bar also provides access to the NEUROSTIMULATOR ON OFF button Figure 5 NEUROSTIMULATOR ON OFF button 2006 03 17 ST te Application name gt 09 26 Lf j Q i RestoreADVANCED Active programmer screen T Start Session Figure 5 Title bar Navigation bar The navigation bar provides access to the application menus and programming functions Figure 6 12 English 8840 8870 V A 2011 04 ete Patient Data Lead Configuration Lead Data Device Data Menu i PROFILE START SESSION 2 MEASUREMENT Start Session Electrode Impedance New Group Print Reports Diary Groups Group Impedance Program myStim Print Screen Diary Days Battery Longevity TargetStim End Session Limits Settings Exit AutoFill Scheduled Therapy Initial Settings Figure 6 Navigation bar wit
47. d you may select different values for each program Off you cannot set any limits Access the PROGRAM mySTIM menu f and select Limits Settings Select a group from the group selection drop down list Figure 39 on page 69 Select the appropriate radio button for amplitude limits or pulse width limits Figure 39 on page 69 If you selected the CUSTOMIZE radio button select the specific values for the limits 8840 8870 V A 2011 04 English 71 5 a Select an entry from the amplitude limits input box or the pulse width limits input box Figure 39 on page 69 The AMP LIMITS screen or the PW LIMITS screen appears Figure 41 RestoreADVANCED Limits Settings Amp limits Group selected Program in operation Upper Limit o Upper limit value Custom o Upper limit type cree Lower Limit Custom Lower limit value Limits information NJK 37713 John Doe Figure 41 Programming individual program limits b Select values for the upper limit tracking or custom and lower custom limit amplitude lower limit should be set to 0 0 V Figure 41 Note The limits are displayed in the information area of the screen c Select the OK button O Hold the programming head steady over the neurostimulator and select the PROGRAM button h To set rate limits for a single group Note The rate is the same for all programs in a group You cannot program rate for individual programs 1 2 3
48. dio button next to the preferred option c Select the OK button O Figure 35 TARGETSTIM OPTIONS screen Select and program a group see Programming with groups and programs on page 48 Note The selected program will become the initial program in the optimization drop down list TargetStim TargetStim has produced three stimulation options Try each option with the patient and select the option with the best patient response Option 1 Active C Option 2 C Option 3 Options 2 and 3 will provide more time between recharges To refine programs using Optimizer 1 Access the PROGRAM mySTIM menu f and select Program myStim Select a numbered program tab in the active group 4 Select the OPTIMIZER button Figure 36 62 English 8840 8870 V A 2011 04 RestoreADVANCED RestoreADVANCED Program myStim Program myStim E dd Pi D SCROLL button Initial Program v Optimization drop down list Program tab SZ Programs C1 Lower Back Upper Leg Amplitude input box JJ amp WM a U N O OPTIMIZER button x Optimizer Save NJK 37713 John Doe NJK 37713 John Doe Figure 36 Using Optimizer Slide the default amplitude slider bar to the desired setting Figure 36 Note The default amplitude setting is a percentage 0 100 of the Initial Program amplitude value and establishes a starting amplitude value for the optimized progra
49. ed into a myStim group Each myStim group and its associated programs can be used to provide a therapy for specific areas of coverage or specific patient activities Pulse width amplitude and electrode polarity are programmed separately for each program within a group that is each program within the group can have different values Rate rate limits SoftStart Stop and cycling are programmed for each group that is each program within the group will have the same values Amplitude and pulse width limits can be programmed for each program in a group In addition limits can be globally programmed for all defined groups ie the same limits are applied to all programs in all groups Groups are designated as A B C etc on the programmer screen and may be given names based on specific areas of coverage specific patient activity or time of use Programs are designated as Kal 6 and LY on the programmer screen A maximum of 26 myStim groups are available for programming A maximum of 32 programs are available between all groups Groups can be active inactive defined or undefined An active group is the group that is currently providing therapy There may be other groups available but they have not been selected they are inactive A defined group is a group that has associated programs An undefined group has no associated programs but is available for creating programs One or more programs within a group may be stimulating programme
50. ed neurostimulator battery service life Figure 23 displayed as OK ERI Elective Replacement Indicator EOS End of Service Review the implanted neurostimulator battery recharge information since the last programming session Figure 23 RestoreADVANCED INS Number Number of recharges Typical duration hrs Recharge duration an extended duration may indicate coupling problems Typical interval days Interval between recharges Typical Coupling Recharge antenna and implantable device couplings performed by the patient A higher coupling number indicates better positioning and faster more efficient recharging Review the details of the charging session Figure 23 RestoreADVANCED INS Date of the charging session Duration of the charging session an extended duration may indicate coupling problems Battery charge level at the end of the recharging session To estimate battery longevity during test stimulation During postoperative test stimulation programming see Pain Test Stim postoperative test stimulation new and follow up on page 26 an estimated time from implant until EOS End of Service can be calculated for the current test stimulation settings This may be useful when programming therapy settings and considering an implanted neurostimulator for your patient Notes Estimated longevity is calculated using a group impedance test The battery longevity calculation is available
51. edtronic GmbH Tel 02159 81490 Fax 02159 8149100 Greece Medtronic Hellas S A Tel 210 67 79 099 Fax 210 67 79 399 Hungary Medtronic Hungaria Kft Tel 1 889 06 00 Fax 1 889 06 99 Ireland Medtronic Ireland Ltd Tel 01 890 6522 Fax 01 890 7220 Italy Medtronic Italia SpA Tel 02 241371 Fax 02 241381 Tel 06 328141 Fax 06 3215812 Japan Medtronic Japan Tel 3 6430 2016 Fax 3 6430 7110 Latin America Medtronic Inc Tel 1305 500 9328 Fax 1786 709 4244 Norway Medtronic Norge AS Tel 067 10 32 00 Fax 067 10 32 10 Poland Medtronic Poland Sp z 0 0 Tel 022 465 69 00 Fax 022 465 69 17 Portugal Medtronic Portugal Lda Tel 21 724 5100 Fax 21 724 5199 Russia Medtronic Russia Tel 8495 580 7377 Fax 8495 580 7378 Slovakia Medtronic Slovakia o z Tel 0268 206 911 Fax 0268 206 999 Spain Medtronic Ib rica S A Tel 91 625 0400 Fax 91 650 7410 Sweden Medtronic AB Tel 08 568 585 00 Fax 08 568 585 01 Switzerland Medtronic Schweiz AG Tel 031 868 0100 Fax 031 868 0199 The Netherlands Medtronic B V Tel 045 566 8000 Fax 045 566 8668 U K Medtronic U K Ltd Tel 01923 212213 Fax 01923 241004 USA Medtronic Inc Tel 1763 505 5000 Fax 1763 505 1000 Toll free 1 800 328 0810 Medtronic Alleviating Pain Restoring Health Extending Life Manufacturer goal Medtronic Inc 710 Medtronic Parkway Minneapolis MN 55432 5604 USA www medtro
52. een display allows you to navigate through the application read statuses and enter data When navigating or entering data use the pointed end of the stylus to make contact with the display screen Do not use sharp objects eg pencils pens paper clips on the touchscreen display Use only the stylus or your fingertip Caution If stylus contact with the touchscreen display results in a different function action or therapy than expected calibrate the touchscreen on the display Note For instructions on calibrating the display see Calibrating the touchscreen on page 96 Navigation and status RestoreADYANCED Start Session p Title bar aoe t amp Navigation bar Figure 3 Navigation and status icons Navigation and status icons are in the following locations Figure 3 Programmer status bar Displays system date and time as well as status of selected functions and components Slider bar Provides access to programmer information system settings and accessories Title bar Displays application name active screen name and the NEUROSTIMULATOR ON OFF button Navigation bar Provides access to application menus Note If a value or button appears gray that option is not available during the current function Programmer status bar The programmer status bar shows the status of peripheral devices the programming head Demo mode and the programmer battery 10 English 8840 8870 V A 20
53. elect a program from the program drop down list e Press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen Access the PROGRAM mySTIM menu and select page 59 TargetStim e Select a program from the drop down list or use the SCROLL RIGHT SCROLL LEFT buttons e Set or modify electrode polarities as needed Set or modify the amplitude as needed Use the TARGETSTIM buttons to transition electrodes while asking the patient to provide responses to the stimulation e Select the OK button Access the PROGRAM mySTIM menu and select page 62 Program myStim e Select a numbered program tab in the active group e Select the OPTIMIZER button e Select an optimization from the drop down list e Press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen e Select the OK button 34 English 8840 8870 V A 2011 04 10 11 2 3 4 Table 5 Programming process continued Procedure If desired review stimulation parameters for all programs in each group If desired estimate battery longevity Note This procedure is available during new or follow up test stimulation Customize device settings Do this Go to page Access the PROGRAM mySTIM menu and select page 49 Program myStim e The stimulation parameters for all programs in the selected group appear on the screen e Select other groups to review using the group selection drop down list e
54. electrodes lowers the lead impedance and makes it harder to deliver the desired voltage An interruption in power has caused the device to reset The current session will end and any unsaved data will be lost Contact Medtronic technical services Service Code A print request was sent from the programmer to the printer but the printer did not respond The IR ports of both devices must be positioned within 1 meter of each other and facing each other directly Certain combinations of high amplitude pulse width and rate settings are not allowed because of high output interlock limits The desired parameter value can only be achieved by reducing one of the other parameter values In this case rate has been reduced automatically The session data manager is full Records must be deleted before more records can be added Table 9 Error and informational messages continued Message SESSION INTERRUPTED Another programmer has communicated with the neurostimulator Exit application SHARED ELECTRODE This electrode is unavailable because of high pulse width or rate settings TARGETmySTIM DISABLED TARGETmyStim is no longer available for one or more groups because of change in parameters Refer to the programming guide for additional information TELEMETRY FAILURE There was interference while communicating with the neurostimulator Reposition the programming head or move away from potential sources of in
55. en are updated throughout the session as programming changes are made Note It is not necessary for the group to be active to view the group parameter settings To review group settings 1 Access the PROGRAM mySTIM menu f and select Program myStim 8840 8870 V A 2011 04 English 49 3 4 Select a group Figure 26 on page 49 from the group selection drop down list The selected group letter appears on the group tab Review the stimulation parameters for all programs in the selected group To review settings for the programs in another group select the group from the drop down list To adjust amplitudes from the group tab Note Amplitude settings can also be adjusted from the program tabs refer to To review modify amplitude resolution and amplitude on page 53 1 2 Access the PROGRAM mySTIM menu f and select Program myStim Select a group from the group selection drop down list The selected group letter appears on the group tab Activate the group by selecting the ACTIVATE button Figure 26 on page 49 Note The group must be active to adjust amplitude settings Use the AMPLITUDE ADJUSTMENT buttons to set the desired amplitudes for each program Figure 27 To turn a program stimulation OFF amplitude is 0 0 V select the checkbox next to the program icon so the check mark is removed Note To reactivate the previous amplitude for the program select the checkbox again RestoreADVANCE
56. ettings 93 Setting localization options 93 To set language date decimal and time format 93 Changing programmer settings 93 To set contrast 94 To set speaker volume 94 To turn key click sound ON or OFF 94 Programmer maintenance 95 Changing the programmer batteries 95 To replace the programmer batteries 95 To replace the lithium back up battery 96 Cleaning the programmer 96 To clean the programmer 96 Calibrating the touchscreen 96 To calibrate the touchscreen 97 Glossary 98 6 English 8840 8870 V A 2011 04 Device description The Medtronic Model 8840 N Vision Clinician Programmer with the Medtronic Model 8870 Application Card is part of a neurostimulation system for pain therapy This manual is designed to provide the information needed to program and troubleshoot the programmable parameters for the RestoreADVANCED Model 37713 Rechargeable Implantable Neurostimulator INS PrimeADVANCED Model 37702 Non rechargeable Implantable Neurostimulator INS Model 37021 External Neurostimulator ENS Model 37022 External Neurostimulator ENS Note Figures showing screen information common to the PrimeADVANCED and RestoreADVANCED neurostimulation systems may display RestoreADVANCED in the title bar Package contents Application card with case Product literature 8840 8870 V A 2011 04 English 7 Introduction The Model 8840 N Vision Clinician Programmer Figure 1 with the Model 8870 Application Card is a hand held device fo
57. extension connector pathways Check group therapy impedance if desired Note Perform this procedure at the end of the session These measurements provide documentation that pathways are intact and the current provided is sufficient for the selected therapy Review patient use information Do this Go to page e Access the MEASUREMENT menu and select Electrode page 42 Impedance e Select the desired amplitude from the drop down list e While holding the programming head steady over the neurostimulator select the MEASUREMENT button e Select the OK button to perform the test Review electrode impedance measurement results Note This procedure takes approximately 1 minute In order to perform measurements this procedure temporarily reprograms the stimulation settings e Access the MEASUREMENT menu and select Group page 44 Impedance e Select the desired group from the group selection drop down list e While holding the programming head steady over the neurostimulator select the MEASUREMENT button e Select the OK button to perform the test Review impedance and stimulation current data for the selected group Access the START SESSION menu and select Diary page 41 Groups to view patient use data by group e Access the START SESSION menu and select Diary Days to view patient use data by day Access the START SESSION menu select Diary Days and select a specific day to review detailed information eg stimulation
58. gramming head steady over the neurostimulator and select a target value from the amplitude values displayed Ramping to the target value begins immediately and the input box displays an arrow pointing from the actual value to the target value Notes If desired fine tune the target value by turning the scroll wheel to increase or decrease the target 54 English 8840 8870 V A 2011 04 To stop the amplitude while it is ramping select the STOP button or depress the scroll wheel To immediately set the amplitude to zero 0 0 V select the AMPLITUDE TO ZERO button To go directly to the target amplitude select the PROGRAM P button on the programmer screen or PROGRAMMING key while the amplitude is ramping Adding groups and programs To provide additional therapy options for your patient you may wish to add new groups or to add new programs to existing groups New groups can be undefined programs are undefined or defined and created from a previously programmed group Adding defined groups provides an efficient method to assemble multiple new groups see Generating new groups using AutoFill on page 56 1 eo gt a Se gt To add and activate a new undefined group Access the PROGRAM mySTIM menu f and select New Group Note Alternatively select Program myStim then select New from the group selection drop down list Select an undefined program tab Figure 31 RestoreADYANCED O Program myStim Gro
59. group and by day The neurostimulator collects the data based on the date and time entered on the DEVICE DATA screen see To enter neurostimulator information on page 39 The time can also be changed by the patient with the patient programmer If a clock change has been programmed by the patient the clinician programmer displays a caution on the screen that the data might be inaccurate ie therapy times are offset because of the clock change Note Patient use information can be viewed throughout the programming session by accessing the START SESSION menu Programming changes made during the session are not updated on the screens associated with this menu RestoreADVANCED Start Session CL dI 2 ht D John Doe RestoreADVANCED 37713 Last session 2006 03 09 Active Group Cc Available groups Use 58 Group Usage Patient use data Battery Observations Stimulation OFF Observations box NJK 37713 John Doe RestoreADVANCED PrimeADVANCED Start Session E J O 1 DB John Doe Prime ADVANCED 37702 Last session 2006 03 09 Active Group Cc Available groups 6 Use 58 Group Usage Service life OK Observations Stimulation OFF PrimeADVANCED Figure 20 START SESSION screen To review patient use data Patient use data are information about how the patient is using the neurostimulator 1 Access the START SESSION menu gt and select Start Se
60. h available menu items Table 3 Menu descriptions Function descriptions e Enter patient and physician information e Configure leads e Enter lead information e Enter neurostimulator implant information e Set neurostimulator date and time e View neurostimulator system information Display name and date of patient session e Display initial active and available groups e Display initial patient use information e Display initial neurostimulator battery level status or service life Display initial system status messages e View patient use data by groups or by days e Perform electrode impedance measurements e Perform group therapy impedance measurements e Check battery level status or battery service life e Estimate battery longevity during test stimulation e Check charge information RestoreADVANCED INS 8840 8870 V A 2011 04 English 13 Table 3 Menu descriptions continued Menu Function descriptions H PROGRAM Display group settings and details mySTIM e Create add and delete groups and programs Program electrode polarity Program amplitude pulse width and rate e Refine programs with Optimizer e Transition electrodes with TargetStim Program Cycling and SoftStart Program patient control limits enable GroupAdjust and TARGETmystim e Return all settings to initial values Generate groups with AutoFill Program a schedule of therapy that repeats every 24 hours gt END SESSION e
61. harging until the recharger displays a new screen indicating the neurostimulator battery charge level and charging efficiency Figure 48 CF ag E lO i BEOC0C000O Figure 48 Screen displaying charge level and charge efficiency 4 Repeat steps 1 3 if the new screen does not appear within 60 minutes 5 Use the clinician programmer to check settings and to turn stimulation ON Error and informational messages The clinician programmer displays text Table 9 below and Table 11 on page 90 and iconic Table 10 on page 90 error and informational messages The patient programmer displays messages that may require patients to contact their physicians Table 12 on page 92 Note Before referring to Table 9 ensure that you have gone through the Telemetry failure checklist on page 82 Table 9 Error and informational messages Message Explanation APPLICATION CARD MISSING When the application card is removed the current session 8840 8870 V A 2011 04 English 85 Table 9 Error and informational messages continued Message The application card has been removed Exit application APPLICATION CARD FAILURE The application card has been corrupted Turn the programmer OFF and contact Medtronic technical services APPLICATION FAILURE The application has been stopped because of an error Contact Medtronic Technical Services Service Code BATTERY WARNING The programmer batteries are low Turn the programmer OFF Repl
62. he devices before surgery To minimize or prevent the effects described below implant the devices on opposite sides of the body and follow any additional instructions Defibrillation therapy from an implanted defibrillator may damage the neurostimulator The electrical pulses from the neurostimulation system may interact with the sensing operation of a cardiac device and could result in an inappropriate response of the cardiac device To minimize or prevent the cardiac device from sensing the neurostimulator output program the neurostimulator to a bipolar configuration and to a minimum rate of 60 Hz Program the cardiac device to bipolar sensing A Cautions When the patient has a cochlear implant minimize or eliminate the potential for unintended audible clicks during telemetry by keeping the external portion of the cochlear system as far from the programming head as possible or by turning off the cochlear implant during programming The N Vision Programmer is not certified for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide The consequences of using the N Vision Programmer near flammable atmospheres are unknown When a patient has a neurostimulator and another active implanted device eg pacemaker defibrillator neurostimulator the radio frequency RF signal used to program these devices may reset or reprogram the other device To verify that inadvertent programming did not occur c
63. he neurostimulator begins a programming session When the neurostimulator is interrogated the programmer identifies the neurostimulator model and reads the current neurostimulator parameters A da 22 Cautions Tousethenonsterile clinician programmer in a sterile field place a sterile barrier between the patient and the programming head to prevent infection Do not sterilize any part of the clinician programmer Sterilization may damage the programmer To ensure successful telemetry hold the programming head steady over the neurostimulator until telemetry is complete If telemetry is interrupted before programming is complete and telemetry cannot be reestablished the session will end and any unsaved data will be lost Do not attempt telemetry near equipment that may generate electromagnetic interference EMI If EMI disrupts programming move the programmer away from the likely source of EMI Examples of sources of EMI are magnetic resonance imaging MRI lithotripsy computer monitors cellular telephones x ray equipment and other monitoring equipment To interrogate the neurostimulator From the THERAPY DESKTOP screen Figure 11 on page 18 position the programming head over the neurostimulator Note If the programming head is docked on the programmer position the programmer so that the programming head is closest to the neurostimulator Hold the programming head steady over the neurostimulator then press the PROGRA
64. he status bar Note For information on battery status and changing the programmer batteries see Changing the programmer batteries on page 95 1 To navigate to the THERAPY DESKTOP screen Turn the programmer ON The APPLICATION SELECTION screen appears Figure 11 on page 18 Select the NEUROSTIMULATION APPLICATION button Sh The THERAPY DESKTOP screen appears Figure 11 on page 18 8840 8870 V A 2011 04 English 19 Transferring patient information Patient data and session data are copied from one application card to another with the Copy Patient Data feature on the UTILITIES tab Depending on the neurostimulator implanted the data copied include patient ID and lead configuration data session reports To transfer patient information 1 Ensure the destination card Application Card 1 is inserted in the programmer 2 From the THERAPY DESKTOP screen Figure 11 on page 18 select the UTILITIES tab 3 Select the COPY PATIENT DATA button Figure 13 Neurostimulation Utilities COPY PATIENT DATA button Figure 13 UTILITIES tab 4 Select the checkbox for the type of data to be copied Figure 14 20 English 8840 8870 V A 2011 04 Neurostimulation Utilities One or more of the following types of data may be copied Select the data you wish to copy W Patient data I Session data Select OK to begin copying data Figure 14 COPY PATIENT DATA screen a Select the Patient data chec
65. hed e See the telemetry failure checklist page 82 The programmer is operating erratically e Move away from any equipment eg MRI lithotriptor page 22 computer monitor that may be generating EMI EMI may cause a disruption in programmer function e An error message or icon appears on the See instructions in the error and informational messages page 85 display section For clinician programmer maintenance questions repairs and returns contact the appropriate Medtronic representative listed on the inside back cover of this manual Telemetry failure checklist The most common corrections for telemetry failures are listed below Refer to Table 9 on page 85 for explanations of specific error messages Decrease the distance between the programming head and the neurostimulator pressing the programming head firmly over the implanted neurostimulator 82 English 8840 8870 V A 2011 04 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button If telemetry fails while holding the programming head steady move the programming head around slowly near the implanted neurostimulator Press the PROGRAMMING P key or select the PROGRAM P button When holding the programming head over the implanted neurostimulator do not drape your hand over the back of the programming head Hold the programming head at the base Ensure that the programmer batteries are not deplete
66. ice Data RestoreADVANCED Device Data Q E 42 Tp Neurostimulator Model No Serial No nn Date and Time Date and time input box ___ Location Location drop down list Implantation Date Implantation date input box ______ ABOUT DEVICE button About Device T Figure 19 DEVICE DATA screen Select the date and time input field to view the current date and time stored in the neurostimulator Figure 19 To reset the date and time use the INCREASE and DECREASE buttons or use the MATCH N VISION button Note The date and time stored in the neurostimulator are used when collecting patient use data and when activating any stimulation parameters that are scheduled to occur based on a 24 hour period see Programming Scheduled Therapy on page 74 Select the neurostimulator implant location from the location drop down list or enter another location Figure 19 Enter the date the neurostimulator was implanted in the implantation date input box Figure 19 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 8840 8870 V A 2011 04 English 39 Reviewing patient use information Review patient use information and neurostimulation system information on the START SESSION screen Figure 20 The neurostimulator collects patient use data between sessions The collected data can also be viewed by
67. ignments up and down on the selected lead e Select the rate input box then select a rate page 52 e Select the pulse width input box then select a pulse width e Press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen e Select the amplitude input box and select an amplitude page 53 resolution setting e Select the amplitude input box again e Select an amplitude setting The amplitude ramps to the target value unless the STOP button or the AMPLITUDE TO ZERO button is selected 8840 8870 V A 2011 04 English 25 Table 4 Screening process with the ENS continued Procedure Do this Go to page 5 If desired set stimulation parameters Access the PROGRAM mySTIM menu and select page 57 by adding modifying programs using Program myStim stored programs e Select an undefined program tab Select a program from the second drop down list e Press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 6 If desired identify and refine e Access the PROGRAM mySTIM menu and select page 59 stimulation parameters using TargetStim TargetStim e Select a program from the drop down list or use the SCROLL RIGHT SCROLL LEFT buttons Set or modify electrode polarities as needed Set or modify the amplitude as needed e Use the TARGETSTIM buttons to transition electrodes while asking the patient to provide responses to the stimulation e Select the OK button 7 If
68. itude during a session Both of these programming methods result in fixed final upper limit values for the patient when the session is ended Lower limits To set lower limits you are only allowed a custom limit selection The lower limit may be set from the lowest available value to the programmed value for amplitude pulse width or rate Note In order to enable TARGETmyStim the amplitude lower limit must be set to 0 0 V 8840 8870 V A 2011 04 English 69 A Cautions Program the lower limit for amplitude to 0 0 V If the patient cannot set the amplitude to 0 0 V the patient may experience uncomfortable or unexpected stimulation jolting or shocking sensation when stimulation is turned on If using custom limits set these limits as the final programming step Setting custom limits before the final step may cause an upper limit to be inadvertently increased to a higher setting which may result in unexpected stimulation to the patient To set limits for all groups A Z is the default group selection when the LIMITS SETTINGS screen is first displayed If using the A Z group selection the following items apply The limit settings will be programmed for all existing and new groups and all programs within each group will have the same set limit values All limits for all groups are changed at once Limits for a specific individual group can be set later to override the A Z limits 1 Access the PROGRAM
69. kbox to add patient ID and lead configuration information from the source card to the destination card b Select the Session data checkbox to add patient reports stored on the source card to the destination card Select OK to begin copying data When prompted remove Application Card 1 and insert the source application card Application Card 2 When prompted remove Application Card 2 and reinsert Application Card 1 Repeat steps 6 and 7 when prompted 9 The card copy will notify you when the copy is complete The files that were copied onto the destination card can now be used in a stim session Using the programmer in Demo mode Note Demo mode can be used to work with the programmer for training and demonstration purposes and to familiarize yourself with the programmer interface before a programming session If Demo mode is selected the programmer remains in Demo mode until the application is exited Demo mode cannot be used to actually interrogate or program a device 8840 8870 V A 2011 04 English 21 da 3 4 To access Demo mode From the THERAPY DESKTOP screen Figure 11 on page 18 select the TO WORK IN DEMO MODE button The DEMO MODE screen appears Select a therapy Select a neurostimulator Select the OK button O Note The neurostimulator icon on the programmer status bar and the Demo mode designation on the title bar show that Demo mode is active Interrogating the neurostimulator Interrogating t
70. lation parameters for additional programs 6 If desired add new groups using AutoFill 7 If desired set stimulation parameters by adding modifying programs using stored programs 8 If desired identify and refine stimulation parameters using TargetStim 9 If desired refine stimulation parameters using Optimizer Do this Go to page e Select the amplitude input box and select an amplitude page 53 resolution setting e Select the amplitude input box again e While holding the programming head steady over the neurostimulator select an amplitude setting e Continue to hold the programming head steady over the neurostimulator until the amplitude ramps to the target value or the STOP button or the AMPLITUDE TO ZERO button is pressed e Select another program tab in the same or different page 55 group e Repeat steps 1 4 of this procedure Note The rate for all programs in a group is always identical e Access the PROGRAM mySTIM menu and select page 56 AutoFill Select the group to generate from the degree of difference and the number of groups to generate e Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen e Access the PROGRAM mySTIM menu and select page 57 Program myStim e Select an undefined program tab e Select Working List Initial Programs or Current Programs from the program types drop down list e S
71. ld the PROGRAMMING P key while the programmer is powering up From the slider bar select the SETTINGS button oe then select the CALIBRATE button Figure 52 on page 97 Select the center of each of the four calibration targets as they appear To ensure proper calibration make your selection as close to the center of the calibration target as possible 8840 8870 V A 2011 04 English 97 Glossary Amplitude The strength of a pulse measured in volts V Application card A small removable memory card that provides mass storage for the programmer contains applications and user data AutoFill Adds new defined groups based on previously programmed groups Current settings Settings the patient experiences during a patient session Custom limit Patient control limit that is set at a fixed value by the clinician Cycling Output is alternately cycled ON and OFF automatically Cycling OFF Time In cycling the length of time between stimulation periods the time of the resting period Cycling ON Time In cycling the length of time that stimulation is delivered Depleted The battery status of a nonrechargeable battery a state of reduced energy of a battery Condition requires that the external device battery be replaced or the implanted device be replaced Discharged The battery charge level for a rechargeable battery state of reduced energy of a battery Condition requires that the battery be charged
72. le 9 Error and informational messages continued Message MEASUREMENT SETTINGS All electrode pairs will be tested Stimulation will change to the following settings during this measurement Press OK to start measurement MEASUREMENT SETTINGS Notify patient that stimulation may change during this measurement Press OK to start measurement OUT OF REGULATION The delivered amplitude may be lower than the programmed amplitude for the indicated programs because of low impedance POWER ON RESET Power on reset has occurred Session will restart PRINTER STATUS Printing in progress Position the programmer with the printer to begin or resume printing RATE REDUCED Rate has been reduced to stay within maximum system capability SESSION DATA MANAGER Session data manager is full Press OK to open the session data manager and delete old records Press Cancel to proceed without deleting any records In this case data will not be saved 88 English 8840 8870 V A 2011 04 Explanation You have chosen to runa measurement test during which stimulation parameters will be set to the values that are listed This will affect patient stimulation while the test is in progress During the group therapy impedance measurement stimulation may change to the parameter values for each program as the impedance is measured for the group This will affect patient stimulation while the test is in progress Adding
73. lect a group or groups from the TARGETmySTIM screen Figure 42 8840 8870 V A 2011 04 English 73 RestoreADVANCED Limits Settings TARGETmyStim Select Groups NJK 37713 John Doe Figure 42 TARGETmySTIM screen 5 Select the OK button O 6 Holdthe programming head steady over the neurostimulator and select the PROGRAM button h Programming Scheduled Therapy Therapy groups can be scheduled to activate and deactivate at specific times during a 24 hour period Each activation and deactivation of a group is called an event Up to 8 scheduled events may be programmed Note Scheduled Therapy operation will be suspended at the beginning of a patient session to prevent scheduled therapy changes from occurring during the session When the session is exited Scheduled Therapy operation resumes To schedule a new event 1 Access the PROGRAM mySTIM menu H and select Scheduled Therapy 2 Select the Scheduled Therapy checkbox Figure 43 to enable the feature if Scheduled Therapy is not active 74 English 8840 8870 V A 2011 04 Note To disable Scheduled Therapy deselect the checkbox and go to step 8 RestoreADVANCED Scheduled Therapy 32 4 p r Scheduled Therapy Drag event to schedule Scheduled Therapy checkbox Empty event blocks Events a Scheduled events Figure 43 Programming Scheduled Therapy To create a new scheduled therapy event drag an empty event block t
74. lide the speaker volume control bar to desired setting Figure 50 on page 94 To turn key click sound ON or OFF 1 Access the slider bar Select the SETTINGS button te 3 Select the KEY CLICK ON OR OFF checkbox Figure 50 on page 94 gt 94 English 8840 8870 V A 2011 04 Programmer maintenance This section covers changing the programmer batteries cleaning the programmer and calibrating the touchscreen Caution Do not use the clinician programmer or application card if they were transported or stored above or below the operating temperature range 10 C 50 F to 40 C 104 F Refrain from using devices until they are stabilized to room temperature and fall within the operating temperature range Devices have potential to malfunction if used outside of the operating temperature range Changing the programmer batteries The programmer operates on four AA alkaline batteries Batteries should be replaced after 40 hours of use or when the battery status icon indicates a low battery lat Batteries must be replaced when the battery status icon indicates the batteries are depleted blinking When no AA batteries are installed the programmer clock runs on a lithium back up battery that is supplied with the programmer The life expectancy of the lithium battery is 3 years Cautions Check the battery status to determine if the batteries in the programmer will last the entire programming session Loss of power
75. linicians familiar with each device should check the programmed parameters of each device before the patient is discharged from the hospital and after each programming session of either device or as soon as possible after these times Also inform patients to contact their physician immediately if they experience symptoms that could be related to either device or to the medical condition treated by either device To prevent possible uncomfortable or unexpected stimulation jolting or shocking sensation program parameter changes in small increments above the perception threshold the amplitude value s at which the patient first perceives paresthesia while evaluating the patient s response verify that the amplitudes are set to 0 0 V before turning on the neurostimulator Stand by mode If the programmer receives no input for 6 minutes Stand by mode is activated In Stand by mode the programmer screen is blank If the programmer is in Stand by mode for more than 1 hour the programmer turns OFF 30 English 8840 8870 V A 2011 04 To return to programming from Stand by mode Slide and momentarily hold the POWER key O The programmer returns to the screen that was displayed at the time Stand by mode was activated Therapy stop Depressing the THERAPY STOP key on the programmer turns the neurostimulator OFF The THERAPY STOP key is available immediately after the THERAPY DESKTOP screen appears Figure 11 on page 18 and thr
76. lish 81 Troubleshooting This section covers noninvasive troubleshooting and error messages relating to the Model 8840 Clinician Programmer with the Model 8870 Application Card Approach troubleshooting conservatively Prior to performing invasive procedures ensure that all noninvasive causes have been considered and contact the appropriate Medtronic representative listed on the inside back cover of this manual Troubleshooting reference guide Table 8 Quick reference troubleshooting guide Problem Possible solution In this manual go to e The power is ON but there is no display Turn the programmer OFF then ON again page 42 The programmer cannot be operated e Install new AA batteries in the programmer Ensure the page 95 Touchscreen does not respond batteries are properly installed page 96 e Calibrate touchscreen Telemetry is interrupted or not initiated Ensure that the application card is correctly inserted page 19 Check the battery status page 11 See the telemetry failure checklist page 82 e Power to the programmer is e Install new AA batteries in the programmer page 95 suddenly interrupted The programmer is not communicating with Clean the IR lens page 96 the printer Ensure that the programmer and printer are directly page 78 facing and within 1 meter 3 3 ft of each other e Contact the printer manufacturer for printer specific troubleshooting information Telemetry cannot be establis
77. ll Range Customize e Off GroupAdjust TARGETmyStim Other Settings SoftStart Stop input box V SoftStart Stop a S ae MW Cycling 15m 15m Cycling input box NJK 37713 John Doe Figure 38 Programming SoftStart Stop and Cycling 66 English 8840 8870 V A 2011 04 To review modify SoftStart Stop SoftStart Stop slowly increases the amplitude when the neurostimulator is turned ON and slowly decreases the amplitude when the neurostimulator is turned OFF The slow ramping may feel more comfortable to sensitive patients 1 Access the PROGRAM mySTIM menu f and select Limits Settings 2 To program SoftStart Stop for a specific group select a group from the group selection drop down list or select A Z to program SoftStart Stop for all existing and new groups Figure 38 3 Select the checkbox next to SoftStart Stop to enable the feature if it is not currently active Note To disable SoftStart Stop deselect the checkbox and go to step 6 Select the SoftStart Stop input box Figure 38 Hold the programming head steady over the neurostimulator wi 4 5 Selecta setting then select the OK button 6 7 Select the PROGRAM button Toreview modify Cycling Cycling turns the neurostimulator ON and OFF at clinician determined intervals eg 0 1 second to 30 minutes Cycling may increase device longevity PrimeADVANCED INS or extend the interval between necessary charges
78. ll wheel in the sections on reviewing modifying electrode polarities pulse width and rate and amplitude To review modify electrode polarities The neurostimulator is bipolar only ie the neurostimulator case is not used as a positive electrode When programming electrode polarity electrodes may be programmed or OFF The electrode configuration must include at least one positive and one negative electrode Notes An electrode may be unavailable for programming X if it is shared by more than one program The amplitude automatically changes to 0 0 V when polarities are changed 1 Access the PROGRAM mySTIM menu f and select Program myStim Select and program a group Select a program tab in the selected group 8840 8870 V A 2011 04 English 51 RestoreADVANCED sl Program myStim Active group C 37 2 Bb Program tab Current Programs X Ibi C1 L Back U L Program label SCROLL WHEEL icon Ret eet She cee I will l 5 6 V Negative electrode a a Positive electrode Electrode programmed OFF Optimizer NJK 37713 John Doe Figure 28 Programming electrode polarities on a program tab Select the electrode or blank OFF options on the lead to be programmed The SCROLL WHEEL icon appears next to the selected lead input box Figure 28 If desired turn the scroll wheel to move electrode polarity assignments up or down one lead at a time or as a pair T
79. m If desired select the amplitude input box to modify the amplitude setting see Reviewing modifying stimulation parameters on page 51 Select an optimization from the optimization drop down list Figure 36 The SCROLL RIGHT SCROLL LEFT buttons provide an alternative method to view and select an option Notes Some optimizations may not be available X due to shared electrodes within the selected group The pending values for electrode settings and amplitude are displayed as each option is selected Review all settings and verify that they are appropriate for your patient Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 8840 8870 V A 2011 04 English 63 Note The pending values for the electrode settings and amplitude become the new settings for the optimized program Naming a group Groups are designated as A B C etc on the programmer screen and may be given names based on specific areas of coverage specific patient activity or time of use Group names selected during programming will be available to the patient as icons or text when they use their patient programmer Notes This programming feature is not available during intraoperative screening or test stimulation Atleast one program must be defined to use this feature To name a group Access the PROGRAM mySTIM menu f and select Program
80. mySTIM menu f and select Limits Settings The LIMITS SETTINGS screen is displayed Figure 39 on page 69 Select A Z from the GROUP SELECTION drop down list Figure 39 on page 69 Select the CUSTOMIZE radio button for the desired parameter amplitude limits pulse width limits or rate limits 4 Select the entry from the input box The AMP LIMITS screen PW LIMITS screen or RATE LIMITS screen appears Figure 40 70 English 8840 8870 V A 2011 04 RestoreADVANCED Limits Settings Amp limits A Z limits da ill Upper Limit Select upper limit values C Custom Tracking Select upper limit type Lower Limit Custom Select lower limit values AN fo a Tp These settings will be applied to all existing groups and will be the default settings for any new groups DO NJK 37713 John Doe Figure 40 Programming A Z limits AMP LIMITS screen shown Select values for the upper limit tracking or custom and lower custom limit amplitude lower limit should be set to 0 0 V Select the OK button O Hold the programming head steady over the neurostimulator and select the PROGRAM button To set amplitude or pulse width limits for a single group Note When programming limits for individual programs in a group there are 3 options es I Full Range you cannot select specific values for limits Customize you may select either custom or tracking for the upper limits an
81. myStim N _ Select a group from the group selection drop down list 3 Activate the group if needed by selecting the ACTIVATE button refer to To activate a group and select a program on page 48 4 Selecta name icon with text for the group from the group name drop down list The name selected for the group appears on the screen 64 English 8840 8870 V A 2011 04 Note The patient programmer allows the patient to select how the group name is displayed on the patient programmer screen text icon or letter Refer to the manual packaged with the patient programmer for more information RestoreADVANCED Ch Program myStim EERI m Clolele _ yy Ul Group name drop down list Sit Stand Lie Walk 2 Sleep 7 Write Day Night Back A LLeg A RLeg A Legs x L Arm XxX R Arm x Arms Hand 3 Foot Figure 37 Naming a group Deleting groups and programs To delete a group 1 Access the PROGRAM mySTIM menu f and select Program myStim 2 Select a group from the group selection drop down list 3 Select the DELETE button dl Notes When a group is deleted all programs in the group are deleted and the group is removed from the scheduled therapy groups event table and the group selection drop down list When a group is deleted its associated letter becomes available for creating a new group To delete a program in a group 1 Access the PROGRAM mySTIM menu H and selec
82. n on the programmer screen To delete a therapy event 1 Access the PROGRAM mySTIM menu f and select Scheduled Therapy 2 Selecta scheduled event on the 24 hour event table Figure 43 on page 75 The EVENT DETAILS screen appears 3 Select the DELETE button I 4 Select the OK button Ph Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen Completing the programming session To review programmed settings A summary of neurostimulator settings programmed during the session are displayed on the END SESSION screen Details of the settings are displayed on the PROGRAM mySTIM screen 1 Access the END SESSION menu gt and select End Session 2 Review settings on the END SESSION screen Figure 44 76 English 8840 8870 V A 2011 04 RestoreADVANCED ps A End Session C CE a p DB John Doe RestoreADVANCED 37713 myStim Summary Active group C Available groups Scheduled Therapy Off SoftS S Cyc TARGET myStim On Off Off On Off Off Off Off Off Off END PATIENT SESSION button NJK 37713 John Doe Figure 44 END SESSION screen 3 To review detailed settings access the PROGRAM mySTIM menu d see Reviewing group settings during programming on page 49 Note Always check the patient control limit settings on the LIMITS SETTINGS screen prior to the patient leaving the office
83. n or movement of the programming head during the telemetry attempt Neurostimulator service life PrimeADVANCED INS or battery level status RestoreADVANCED INS can be checked without beginning device life Device life begins the first time a lead is configured 8840 8870 V A 2011 04 English 89 Table 10 Iconic error messages Error message Explanation Application card missing Application card error THERAPY STOP key pressed with no application active PROGRAMMING P key pressed with no application active Hardware software failure message j Contact the appropriate Medtronic representative listed on the inside back cover of this manual Observation window messages The Observation box appears on the START SESSION screen when the START SESSION menu is accessed The Observation box provides brief messages about significant system events that need to be investigated These messages and their explanations are displayed in Table 11 Table 11 Observation box messages and explanations Event message Explanation Check TestStim clock The time difference between the ENS clock and the clinician programmer clock is greater than 90 English 8840 8870 V A 2011 04 Table 11 Observation box messages and explanations continued Event message Explanation one hour Check the ENS clock setting to ensure it is set properly TestStim clock has changed The patient has changed the ENS clock using the patient
84. ng head steady over the page 22 neurostimulator page 82 e Press the PROGRAMMING key The light on the back of the programming head will flash green while telemetry is ongoing and will stop flashing when telemetry is finished e If no error messages appear continue If an error message appears see the troubleshooting section Access the PROFILE menu page 37 Enter patient information e Configure the leads Enter the lead information Enter neurostimulator and implant information e Set neurostimulator date and time e Access the START SESSION menu and select Start page 40 Session e Review patient use information e Check the Observations box for significant system events that have occurred e If the neurostimulator is OFF hold the programming head page 42 steady over the neurostimulator then select the NEUROSTIMULATOR ON OFF button e Access the MEASUREMENT menu and select Battery page 45 e Check the battery level icon RestoreADVANCED INS and ENS The icon displayed indicates the battery level status at 100 75 50 25 or 0 e Review the neurostimulator service life displayed as OK ERI or EOS Review the neurostimulator recharge information RestoreADVANCED INS 32 English 8840 8870 V A 2011 04 2 Table 5 Programming process continued Procedure Check electrode impedance Note Perform this procedure at the beginning of the session These measurements verify the integrity of lead
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86. nnecting the snap lid connector cable to the lead extension Selecting an application Screening and test stimulation options are available from the TESTSTIM SELECTION screen after initial interrogation when the ENS is identified see Figure 15 on page 24 8840 8870 V A 2011 04 English 23 Intraoperative screening option Pain Test Stim C Intraoperative Previous session will be cleared New test stimulation option New Previous session will be cleared Test stimulation follow up option Follow up Previous session will be retained Figure 15 TESTSTIM SELECTION screen for programming the ENS When the intraoperative screening option or the new test stimulation option is selected information from a previous session is cleared from the ENS Pain Test Stim intraoperative screening Intraoperative screening is primarily used to identify optimal lead position Refer to Table 4 on page 24 for basic instructions for screening with the Model 8870 application card Use the reference page numbers listed in Table 4 to find additional information in other sections of the manual To use the programmer for intraoperative screening Caution To prevent possible uncomfortable or unexpected stimulation jolting or shocking sensation program parameter changes in small increments above the perception threshold the amplitude value s at which the patient first perceives paresthesia while evaluating the patient s response
87. o move polarity assignments as a pair both leads must be selected so the SCROLL WHEEL icon appears next to both input boxes To deselect one lead from the pair select a nonelectrode area in the lead input box for the unwanted lead The SCROLL WHEEL icon disappears If desired set other parameters on this screen refer to To review modify the pulse width or rate on page 52 Note If you are creating a new program you must select electrode polarities and pulse width and rate values before programming see Adding groups and programs on page 55 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen To review modify the pulse width or rate Pulse width is the duration of the pulses The patient experiences pulse width as the strength or coverage of the paresthesia Rate is the frequency of pulses in hertz The patient experiences rate as the smoothness of the paresthesia 52 English 8840 8870 V A 2011 04 Caution To prevent possible uncomfortable or unexpected stimulation jolting or shocking sensation decrease the amplitude to the perception threshold the amplitude at which the patient first perceives paresthesia before changing the pulse width After changing the pulse width slowly increase the amplitude Note When using more than one program in a group the rate is the same for all programs in the group 1 2 3 4
88. o set language date decimal and time format 1 Access the slider bar 2 Select the LOCALIZATION button 3 Select a language date decimal or time format option Figure 49 Language drop down list Date format drop down list YYYY MM DD Date set boxes yyyy TL am Decimal format drop down list 2 s mm ss apes Time set boxes Figure 49 LOCALIZATION screen 4 Select the desired format from the drop down list Changing programmer settings The programmer settings control the contrast volume and key click The speaker volume setting adjusts the volume for tones that signal programming events and conditions eg success error alert failure 8840 8870 V A 2011 04 English 93 This setting does not control the volume of the key click sound The key click is the sound made when the stylus contacts the touchscreen The key click sound can be turned ON and OFF N VISION gt j 5S g ea LEN Contrast control 0 i 4 GA E Volume control KEY CLICK ON OR OFF checkbox Figure 50 PROGRAMMER SETTINGS screen To set contrast Access the slider bar da 2 Select the SETTINGS button fe 3 Slide the contrast control bar to desired setting Figure 50 Note Two shades of gray should be visible for optimal viewing of icons and text in the application Tosetspeaker volume 1 Accessthe slider bar 2 Selectthe SETTINGS button fe 3 S
89. o the 24 hour event table that displays all scheduled events Figure 43 The EVENT DETAILS screen appears Select a group from the group selection drop down list on the EVENT DETAILS screen Use the INCREASE and DECREASE buttons to set the scheduled therapy ON and OFF times Note The application prevents overlapping scheduled events by using the end of the previous event and the start of the next event to adjust event blocks appropriately Select the OK button to place the new event s on the event table Drag additional empty event blocks to the event table as desired and repeat steps 4 6 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen To modify a therapy event Access the PROGRAM mySTIM menu f and select Scheduled Therapy Select a scheduled event on the 24 hour event table Figure 43 on page 75 The EVENT DETAILS screen appears 8840 8870 V A 2011 04 English 75 3 Use the INCREASE and DECREASE buttons to modify the scheduled therapy ON and OFF times or use the group selection drop down list to change the group for that time period 4 Select the OK button Select additional scheduled events as desired and repeat steps 3 and 4 to place the new event s on the event table Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P butto
90. ogrammer warnings and precautions device description package contents device specifications and instructions for use Refer to the clinical summary booklet packaged with the neurostimulator for information on the clinical study results of the neurostimulation system and individualization of treatment 8840 8870 V A 2011 04 English 3 To check programmer battery status 19 To navigate to the THERAPY DESKTOP screen 19 Transferring patient information 20 To transfer patient information 20 Using the programmer in Demo mode 21 To access Demo mode 22 Interrogating the neurostimulator 22 To interrogate the neurostimulator 22 Programming for intraoperative screening and postoperative test stimulation 23 ENS preparation 23 Selecting an application 23 Pain Test Stim intraoperative screening 24 To use the programmer for intraoperative screening 24 Pain Test Stim postoperative test stimulation new and follow up 26 To use the programmer for a new test stimulation session 26 To use the programmer for a follow up test stimulation session 26 Programming the neurostimulator 28 myStim groups and programs 28 High output interlocks and shared electrodes 29 Programming warnings and cautions 30 Stand by mode 30 To return to programming from Stand by mode 31 Therapy stop 31 To stop therapy 31 Resolving pending values 31 Basic programming steps 32 Entering patient and physician information 36 To enter patient information 37 Entering device info
91. only when a program has been defined refer to Programming with groups and programs on page 48 Under some conditions such as low amplitudes less than 0 25 V or narrow pulse widths a battery longevity calculation cannot be obtained You may need to decrease parameters to avoid patient discomfort If parameters are adjusted the longevity calculation will be affected Access the MEASUREMENT menu FS and select Battery Longevity 46 English 8840 8870 V A 2011 04 TestStim TestStim Battery Longevity Battery Longevity E 5 2 4 BD Neurostimulator Battery Gs CC 4 DB Neurostimulator Battery GS Estimated Longevity Group selection drop down list Estimated Longevity Not available At Group C settings estimated time from implant te EOS Longevity results Prime ADVANCED 1 5 2 years RestoreADVANCED 9 years RestoreULTRA 9 years Longevity will vary based on patient s usage MEASUREMENT button Figure 24 BATTERY LONGEVITY screens 2 Select a group from the group selection drop down list Figure 24 Notes The group selected can be active or inactive f no groups are defined the group selection field will be empty Not available appears on the screen until the test is run Select the MEASUREMENT button Figure 24 Review the longevity test results for the estimated time from implant until EOS End of Service Returning to initial settings during programming During a p
92. oughout a patient session The THERAPY STOP key is not available while the Model 8870 application is loading or when files are being copied to the application card During a patient session if tte THERAPY STOP key is depressed during the electrode impedance test the programmer turns the neurostimulator OFF and returns the neurostimulator parameters to the pretest settings To stop therapy Hold the programming head steady over the neurostimulator then depress the THERAPY STOP key Resolving pending values During a programming session changes to parameters that have not yet been programmed to the neurostimulator are considered pending While you have pending values on the screen you cannot navigate via the navigation bar to any other screens unless you cancel or program the pending values Pending values are presented in two ways A pending flag appears next to the changed parameter or checkbox The target pending value appears below the current value and an arrow appears between the values Programming pending values See the programming procedures in this manual for information on how to program pending values When pending values are programmed the following occurs The pending flag disappears from the screen The target pending value becomes the current value Cancelling pending values When pending values are cancelled the currently programmed values are again displayed on the screen C
93. p or select A Z for all groups e Select the desired radio button for the desired parameter e If setting custom limits select the amplitude limits pulse width limits or rate limits input box then select the upper and lower limits for amplitude pulse width or rate Hold the programming head steady over the neurostimulator and program the settings Access the PROGRAM mySTIM menu and select Limits page 73 Settings e Select A Z from the group selection drop down list e Select the checkbox next to GroupAdjust to turn the feature on e Hold the programming head steady over the neurostimulator and program the settings 8840 8870 V A 2011 04 English 35 Table 5 Programming process continued Procedure 5 If desired review modify TARGETmyStim Program Scheduled Therapy events 1 If desired program times for therapy groups to turn ON and OFF automatically Complete the programming session 1 Review programmed settings 2 Print report 3 Exit application Do this Go to page e Access the PROGRAM mySTIM menu and select Limits page 73 Settings e Select A Z from the group selection drop down list e Select the TARGETmySTIM button e Select the applicable group or groups e Select the OK button e Hold the programming head steady over the neurostimulator and program the settings Access the PROGRAM mySTIM menu and select page 74 Scheduled Therapy If needed select the SCHEDULED THERAPY check
94. p use data To view the patient use data by day Access the START SESSION menu gt and select Diary Days Review the patient use data per day on the collection period calendar Select a specific day on the calendar to view the patient use data in detail for that day Events displayed include Active groups Number of patient adjustments Stimulation ON periods Recharge periods RestoreADVANCED INS Low battery periods RestoreADVANCED INS and ENS 8840 8870 V A 2011 04 English 41 Turning the neurostimulator ON or OFF Turning the neurostimulator ON allows the neurostimulator to deliver stimulation to the patient Before changing any parameters during a session turn the neurostimulator ON so that the patient can feel the changes being programmed Note Patients with extremely high sensitivity to stimulation may sense the transmission of the telemetry signals Caution Before turning on the neurostimulator decrease the amplitude s to 0 0 V Decreasing the amplitude s prevents possible uncomfortable or unexpected stimulation jolting or shocking sensation when stimulation is turned on To turn the neurostimulator ON or OFF Select the NEUROSTIMULATOR ON OFF button to turn the neurostimulator ON QB or OFF Checking system performance Recommendations when using measurement functions The measurement functions assist in identifying problems with system components or the entire implanted system
95. prevent or minimize uncomfortable or unexpected stimulation jolting or shocking sensation wait for the patients response to stimulation changes while transitioning electrodes ifthe patient experiences uncomfortable stimulation decrease the amplitude reverse the electrode transition or turn the neurostimulator off Notes The transition progress bar fills to indicate status When the electrodes are fully transitioned the bar fills and disappears Depending on the lead configuration selected and the status of the electrodes ie fully transitioned the TARGETSTIM buttons are enabled or disabled and transitioning the electrodes is possible up down or across the leads If desired use the MARK button to save an effective therapy setting and continue transitioning the electrodes Notes The RECALL button returns to the last therapy setting marked Ensure either the OK button or the CANCEL button Bh is selected once TargetStim is initiated Programmed SoftStart parameters can change during TargetStim use Select the OK button to activate the group Note The patient will feel a change in therapy immediately when you activate the group If the selected stimulation is a combination of two programs a message appears Figure 35 a Evaluate the patient s response to each of the options by selecting the radio button to activate each option 8840 8870 V A 2011 04 English 61 b Select the ra
96. r programming Medtronic devices for Medtronic Neurological therapies The programmer is used to review and program device parameters using telemetry a radio frequency RF communication The programmer is also used to set limits for the patient control devices If using a programmer for the first time see the set up instructions on the Getting Started card that is packaged with the programmer Programmer components Therapy stop key Stylus storage Infrared port Magnet slot ylu g Programming head Scroll wheel Speaker Programming key Application card port Cable reel Application card ejection key Power key Battery compartment Touchscreen display Expansion port Figure 1 N Vision clinician programmer components Caution Do not use the expansion port The expansion port is a testing port used by Medtronic personnel Connecting any equipment to this port may damage the programmer Therapy stop key Stops all active therapy Touchscreen display Programmer touchscreen for display and data input Infrared IR port Allows communication with compatible printers or devices Scroll wheel Turning the wheel scrolls up and down to adjust values for some functions Programming key Depressing the key initiates interrogation or programming for some functions Application card port Slot for the application card 8 English 8840 8870 V A 2011 04 Application card ejection key Eject
97. r while performing the remaining programming functions 5 From the second drop down list on the screen select a program Figure 34 The SCROLL RIGHT SCROLL LEFT buttons provide an alternative method to view and select a program 60 English 8840 8870 V A 2011 04 10 11 Notes lf no groups are currently defined New Program will appear with gray text in the drop down list indicating that option is not available for the current function Electrodes will need to be programmed Ifa group is defined and New Program is selected a default pulse width 450 us will be applied Amplitude will be set to zero 0 0 V and the rate will be applied from the group Electrodes will need to be programmed Ifa group is defined and a program is selected rate pulse width and amplitude will be applied from the group selected and the program will be providing stimulation at the programmed settings Set or modify electrode polarities as needed Select the electrode or blank OFF options on the lead to be programmed Set or modify the amplitude as needed Use the scroll wheel or the AMPLITUDE ADJUSTMENT buttons Figure 34 while asking the patient to provide responses to the stimulation Note The amplitude will be set to zero 0 0 V if the neurostimulator is turned OFF Use the TARGETSTIM buttons Figure 34 to transition the electrodes while asking the patient to provide responses to the stimulation Caution To
98. ration must include at least one positive and one negative electrode INVALID SETTINGS Invalid settings have been detected All settings will be cleared Explanation programmer using this version of the application card The device was programmed by a clinician programmer using a different newer version of the application card It can be programmed using this version of the application card but the device settings will be cleared The device cannot be programmed by this clinician programmer A new application card must be obtained Selecting OK will end this patient session without exiting the application Selecting OK will end this patient session The application will return to the THERAPY DESKTOP screen When more than 1 program within a group uses the same electrode certain restrictions are applied to prevent the highest pulse width of the group from exceeding 450us Initial settings are the settings observed on the PROGRAM mySTIM screen at the beginning of the current session Returning to initial settings will delete any values that were changed or are pending in the current session An invalid electrode setting exists Electrode configuration must be changed to a valid setting before continuing Device cannot be programmed using the detected settings Selecting OK will clear the settings and you will be required to reprogram the device 8840 8870 V A 2011 04 English 87 Tab
99. rmation 37 To program lead configuration 38 To enter lead model number 38 To enter neurostimulator information 39 Reviewing patient use information 40 To review patient use data 40 To review neurostimulation system information 41 To view the patient use data by group 41 To view the patient use data by day 41 Turning the neurostimulator ON or OFF 42 To turn the neurostimulator ON or OFF 42 Checking system performance 42 Recommendations when using measurement functions 42 4 English 8840 8870 V A 2011 04 Returning to initial settings during programming 47 To return to initial settings 47 Programming with groups and programs 48 To activate a group and select a program 48 Reviewing group settings during programming 49 To review group settings 49 To adjust amplitudes from the group tab 50 Reviewing modifying stimulation parameters 51 To review modify electrode polarities 51 To review modify the pulse width or rate 52 To review modify amplitude resolution and amplitude 53 Adding groups and programs 55 To add and activate a new undefined group 55 To add new programs to an existing group 55 Generating new groups using AutoFill 56 Adding modifying programs using stored programs 57 To add modify programs using stored programs 57 To save programs to the Working List 59 Programming using TargetStim and Optimizer 59 To create modify programs using TargetStim 59 To refine programs using Optimizer 62 Naming a group 64 To name a group 64 Deleting group
100. rogramming session you can reset all parameters to values in effect at the start of the session If you return to initial settings however you will lose all changes made to group and program parameters including Scheduled Therapy groups during the session To return to initial settings 1 Access the PROGRAM mySTIM f menu 2 Select Initial Settings 8840 8870 V A 2011 04 English 47 Programming with groups and programs To program stimulation parameters a therapy group must be selected and activated Within an active group 1 to 4 programs of stimulation may be programmed with any or all programs in the group providing stimulation A program provides stimulation when the amplitude is set greater than 0 0 V See Figure 25 for an example of an active group with programs that could appear on the PROGRAM mySTIM screen Program currently stimulating sprites display Active Group sprites display Cl lt Program that is programmed but not stimulating amplitude is 0 0 V Undefined program tabs available for programming Figure 25 Active group with programs Notes When the maximum number of programs between all groups has been programmed the remaining program tabs are identified as unavailable with an X To program the implanted neurostimulator for the first time stimulation parameters except for amplitude must be programmed in the selected group before the group becomes active
101. s and programs 65 To delete a group 65 To delete a program in a group 65 Customizing device settings 66 To review modify SoftStart Stop 67 To review modify Cycling 67 Programming a neurostimulator for patient control 67 To set limits for all groups 70 To set amplitude or pulse width limits for a single group 71 To set rate limits for a single group 72 To enable GroupAdjust 73 To enable TARGETmyStim 73 Programming Scheduled Therapy 74 To schedule a new event 74 To modify a therapy event 75 To delete a therapy event 76 Completing the programming session 76 To review programmed settings 76 Printing session reports 77 8840 8870 V A 2011 04 English 5 To print a report during the session 78 To print a report after the session 78 To view a report from the Session Data Manager 79 Managing session data files 80 To delete patient session files 80 Printing the screen 81 To print the current screen 81 Ending the current patient session 81 To end the current patient session 81 Exiting the application 81 To exit the application 81 Troubleshooting 82 Troubleshooting reference guide 82 Telemetry failure checklist 82 Impedance and stimulation current measurements 83 Reading serial numbers 83 To read the neurostimulator serial number 83 To read the clinician programmer serial number 83 Physician Recharge Mode RestoreADVANCED Neurostimulator 84 To perform a physician charging session 84 Error and informational messages 85 System and programmer s
102. s the application card from the programmer Power key O Turns the programmer ON and OFF reactivates the programmer after Stand by mode Expansion port Do not use currently only used for Medtronic testing Magnet slot Holds the Model 8529 magnet the Model 8529 magnet is not used for all therapies and devices Programming head Allows the programmer to communicate with the device Cable reel Stores a 1meter 3 3 ft extendable cable that connects the programming head to the programmer Speaker Programmer speaker Battery compartment Contains the programmer batteries tylus wUse to enter data through the touchscreen display Printer The optional Model 3445 Seiko DPU Printer Figure 2 communicates with the programmer via IR signals The printer is available in the Medtronic Model 8527 Printer Kit SII Seiko Instruments y Figure 2 Model 3445 Seiko DPU printer Most standard desktop printers with IR capability and protocol IrDA 1 0 compliant at data rates of 9600 and 57 600 bits per second may also be used with the programmer A desktop printer must have IR capability or must be fitted with a commercially available IR converter Note IR functionality is only intended for communication between the N Vision Programmer and the designated printers Any other use is not certified by Medtronic 8840 8870 V A 2011 04 English 9 Navigation status and data entry The touchscr
103. sia Optional features Cycling Cycles the neurostimulator ON and OFF at programmed intervals SoftStart Stop Slowly increases the amplitude when the stimulation is turned ON and slowly decreases the amplitude when the stimulation is turned OFF Scheduled Therapy Turns specific groups ON and OFF at programmed times based on a 24 hour clock Patient Control Limits Sets upper and lower limits for patient adjustment of parameters GroupAdjust Allows the patient to increase or decrease all program amplitudes in the active group at the same time TARGETmyStim Allows the patient to move stimulation settings from electrode to electrode up and down the lead myStim groups and programs A program is a specific combination of pulse width rate and amplitude settings acting on a specific electrode combination up to 16 electrodes per program A program defines the stimulation pulses that will be delivered for therapy Multiple programs can be used to maximize pain coverage When using more than one program the pulses are delivered sequentially first a pulse from one program then a pulse from the next program and so on Figure 16 Pulses from different programs are never delivered simultaneously 28 English 8840 8870 V A 2011 04 Group with 4 programs Programs Thera z 1 2 3 4 1 2 3 4 RY Figure 16 Using multiple programs within a group to maximize pain coverage Up to four programs can be combin
104. ssion 40 English 8840 8870 V A 2011 04 N SN i e OS View the following patient use data Figure 20 Active group the group that is currently providing therapy Available groups the initially interrogated number of groups Use Percentage of neurostimulator ON time since the last follow up session Group Usage Bar graph presentation of the percentage of neurostimulator ON time for the available groups To review neurostimulation system information Access the START SESSION menu gt and select Start Session Review the Observations box for significant system events that have occurred Figure 20 The observations are brief notifications eg Check INS clock Stimulation off that need to be investigated see Table 11 on page 90 Check the battery level status RestoreADVANCED INS The icon displayed indicates the battery level status at 100 75 50 SB 25 SB or 0 B Review the implanted neurostimulator battery service life PrimeADVANCED INS displayed as OK ERI Elective Replacement Indicator EOS End of Service For additional information on checking battery status refer to To check neurostimulator battery information on page 45 To view the patient use data by group Access the START SESSION menu gt and select Diary Groups If desired select the appropriate button to sort the displayed data by group alphabetically or by percentage used Review the grou
105. stment or INS replacement may be needed to increase therapy time between charges RestoreADVANCED INS Stimulation OFF Stimulation was OFF when the ENS INS was interrogated by the programmer at the start of the session a Messages remain in the Observation box from session to session until the needed action is taken The only exceptions are the Charge sooner or Charge daily messages that are cleared at the end of a session Patient programmer messages The patient programmer also displays text and iconic error and informational messages Some messages provide an error code and tell the patients to contact their physician These error codes and their troubleshooting procedures are displayed in Table 12 Contact the 8840 8870 V A 2011 04 English 91 appropriate Medtronic representative listed on the inside back cover of this manual if additional assistance is needed Table 12 Patient programmer Contact Physician error codes Error code 536 537 574 OOR POR 556 589 575 578 0 to 250 92 English Explanation Moisture was detected inside the ENS The ENS must be dried with a towel the battery removed and the battery compartment allowed to air dry at room temperature The EMERGENCY STOP key on the ENS is active Check the key and replace the device if needed No programs or groups were saved by the clinician programmer The neurostimulator must be reprogrammed Out of Regulation situation has occurred Decrease
106. sum of all pulse widths in the group must not exceed 450 us 8840 8870 V A 2011 04 English 59 The group rate rate multiplied by the number of programs in the group must not exceed 260 Hz 1 Select and program a group refer to Programming with groups and programs on page 48 or go to next step if using TargetStim with no groups currently defined 2 Access the PROGRAM mySTIM menu f and select TargetStim The TARGETSTIM screen is displayed Group selection drop down list RestoreADVANCED Program myStim TargetStim Group C RestoreADVANCED le Program myStim fm SCROLL button cil gt AMPLITUDE ADJUSTMENT buttons oO _ Program drop down list l I E E DL sull 2 Ao H Eey 2 Electrodes transitioning DI hd a A 3 a 3 E 1 E 4 E i E pe 240 ps 5 E 5 E 13 vc 46 do Mia 50 Hz n 43 915 Mark Transition progress j TargetStim gt TargetStim Thu TARGETSTIM buttons Jom DO i Vv x i NJK 37713 John Doe gt PF NgJks 37713 John Doe Figure 34 Using TargetStim 3 Select a group from the group selection drop down list Figure 34 Note If no groups are currently defined New Group appears in the group selection drop down list and default settings for rate 50 Hz and pulse width 450 us will be applied Amplitude will be set to zero 0 0 V 4 Holdthe programming head steady over the neurostimulato
107. t Program myStim 2 Select and program a group refer to Programming with groups and programs on page 48 3 Select the numbered tab for the program you want to remove 8840 8870 V A 2011 04 English 65 4 Select the DELETE button 1 Note If the deleted program was the only remaining program in the group the group will be deleted also 5 Select the OK button O Customizing device settings The SoftStart Stop and Cycling features located on the LIMITS SETTINGS screen are optional These features are designed to increase patient comfort and ease of use as well as increase device longevity PrimeADVANCED INS or extend the interval between necessary charges RestoreADVANCED INS Programmed settings for these features are the same for all programs in a group These features can be programmed for each individual group or the features can be programmed for all existing and new groups using the A Z group selection Note The screens presented in this manual are representative of specific Medtronic neurostimulator applications Features represented may not be available with all external neurostimulator models during test stimulation or with all implantable neurostimulator models during programming RestoreADVANCED 4 Limits Settings L I i D myStim Settings Group 3 Group selection drop down list Amp limits Full Range Customize QU Off PW limits QC Full Range amp Customize le Off Rate limits amp Fu
108. t results Notes Ifthe test results show high impedance possible open circuit confirm the result by performing the test at different voltage settings 8840 8870 V A 2011 04 English 43 Testresults can be viewed any time during the programming session by returning to the ELECTRODE IMPEDANCE screen To check group therapy impedance Group therapy measurements are impedance and stimulation current measurements taken at the programmed settings for each program in a group Notes Under some conditions such as low amplitudes less than 0 25 V or narrow pulse widths a measurement cannot be obtained You may need to decrease parameters to avoid patient discomfort The neurostimulator reports current measurement values as current delivered during the stimulation pulse instead of current averaged over the rate period Current measured during the pulse does not change with rate settings and the values are higher than current that is averaged 1 Access the MEASUREMENT menu SH and select Group Impedance Position the programming head over the neurostimulator Select a group from the group selection drop down list Figure 22 RestoreADYANCED Group Impedance Group selection drop down list Settings C alll g C1 5 60 c2 2 35 c3 4 10 Results C MEASUREMENT button NJK 37713 John Doe Figure 22 GROUP IMPEDANCE screen 44 English 8840 8870 V A 2011 04 4 Select the MEASU
109. terference and press Retry Press Cancel to exit application TELEMETRY FAILURE There was no response from the neurostimulator device Reposition the programming head and press Retry Press Cancel to exit application WELCOME If neurostimulator will be implanted press OK to proceed This will begin device service life If neurostimulator will not be implanted at this time press Cancel to end session Explanation A different programmer has communicated with the neurostimulator and could have changed settings Certain restrictions are applied to prevent the highest group pulse width or the group rate rate multiplied by the number of programs in the group from exceeding 450us or 260 Hz If the values are high then additional electrodes are unavailable Stimulation settings have been changed and are no longer compatible with TARGETmyStim Make sure the electrode pattern in the program is able to move up and down the lead the amplitude limits are enabled and the amplitude lower limit is 0 0 V In addition make sure group pulse width does not exceed 450 us and group rate does not exceed 260 Hz Telemetry did not complete because of electrical or magnetic interference from the environment or other devices nearby To complete telemetry the programming head must be placed closer to the neurostimulator or you must move away from sources of the interference Telemetry did not occur because of the locatio
110. tion will delete all device and session information associated with the current lead configuration Deleting the group will delete the group and all programs associated with the group If the group is active it will also be deleted from the device If this is the only program ina group deleting this program will delete the program and the group from the device and the group list Selecting OK will delete this event from the Scheduled Therapy 24 hour event table This device cannot be programmed by the clinician Table 9 Error and informational messages continued Message Detected device is not supported by this version of application card Contact Medtronic technical services DEVICE NOT SUPPORTED This neurostimulator was last programmed with an incompatible version of the application card Press Cancel to exit the application and contact Medtronic technical services or press OK to clear all settings and start session DEVICE NOT SUPPORTED The detected device is not supported by this application card Refer to the technical manual for a listing of supported devices Press OK to end this session END SESSION Select OK to end session EXIT APPLICATION Select OK to exit application HIGH PULSE WIDTH Higher pulse widths are unavailable because programs share 2 or more electrodes INITIAL SETTINGS Press OK to reset all parameters to values in effect at start of session INVALID ELECTRODE Electrode configu
111. tional message that appears on the screen Adding modifying programs using stored programs Programs retrieved from the neurostimulator at the start of a programming session or programs created during the current session may be recalled to quickly assemble new programs See Table 6 for a description of the types of programs available Table 6 Program types Program type Definition Initial programs The programs retrieved from the neurostimulator at the start of the session Current programs All programs as currently programmed during the session Working lists Saved programs created during a session These programs are deleted at the end of a programming session To add modify programs using stored programs 1 Access the PROGRAM mySTIM menu f and select Program myStim Select and program a group refer to Programming with groups and programs on page 48 To add a new program select an undefined program tab in the group Figure 33 To modify a program select a numbered program tab in the group 4 Select one of the program types refer to Table 6 from the first drop down list on the PROGRAM mySTIM screen Figure 33 8840 8870 V A 2011 04 English 57 Undefined program tab RestoreADVANCED 2 Program myStim Program types drop down list Current Programs v a 4 tb SCROLL button 4 C1 Lower Back Upper Leg Program drop down list NJK 37713 John Doe Figure 33 Using stored programs 5
112. trode to electrode up and down the lead 8840 8870 V A 2011 04 English 67 Note The patient can use the patient programmer to reset stimulation parameters to the original clinician settings To program the ranges in which a patient can adjust the amplitude pulse width and rate you must set an upper limit value and a lower limit value for each stimulation parameter For amplitude and pulse width program upper and lower limits individually for each program in a group Rate limits however are always programmed for all programs in a group Limits can be set for active or inactive groups Limits can be set for individual groups or globally programmed for all defined groups using the A Z group selection ie the same limits are applied to all programs in all groups Three limit types are available for each stimulation parameter Table 7 Table 7 Limit types Limit type Definition Full Range If this limit type is selected the patient is able to adjust the value for the selected stimulation parameter within the entire range provided by the neurostimulator Customize If this limit type is selected clinician set limits custom or tracking are programmed The patient is able to adjust the selected stimulation parameter within these limits Off If this limit type is selected the patient is not able to adjust the value for the selected stimulation parameter When using the A Z group selection all limits for all groups are changed at once
113. up selection drop down list f f i Undefined programs maale ma Current Programs all gt Change electrode to continue GI Figure 31 Creating a new undefined group Select values for electrode polarities pulse width and rate To activate the group and program the new stimulation settings hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen Select an amplitude value To add new programs to an existing group Access the PROGRAM mySTIM menu f and select Program myStim Select and program a group refer to Programming with groups and programs on page 48 Select an undefined program tab in that group Figure 31 Select values for electrode polarities and pulse width 8840 8870 V A 2011 04 English 55 5 Hold the programming head steady over the neurostimulator then press the PROGRAMMING P key or select the PROGRAM P button on the programmer screen 6 Select an amplitude value Generating new groups using AutoFill To provide additional therapy options for your patient you may wish to add new groups created from a previously programmed group AutoFill provides an efficient method to assemble multiple new groups Note All new groups generated have program amplitudes set at 0 0 V To add and activate new groups 1 Access the PROGRAM mySTIM menu f and select AutoFill RestoreaD YANCE
114. values are displayed on the screen The amplitude value can be modified for the electrode impedance test by choosing an amplitude value from the drop down list on the screen At the end of the test the most recently programmed settings are restored 42 English 8840 8870 V A 2011 04 This procedure tests all unique bipole combinations The procedure takes approximately 1 minute 1 Access the MEASUREMENT menu PS and select Electrode Impedance 2 Select an amplitude value from the drop down list Figure 21 Note Perform the lead impedance test at the 0 7 V default setting Additional amplitude values are available to confirm test results RestoreADVANCED Electrode Impedance L J 2 T D Settings wall Ci v us Hz Amplitude value drop down list 70 80 100 Out of Range Results Electrodes n None All Results Reference M a oUl Se WN 10 11 12 13 14 15 MEASUREMENT button NJK 37713 John Doe Figure 21 ELECTRODE IMPEDANCE screen Position the programming head over the neurostimulator Select tte MEASUREMENT button Figure 21 5 Select the OK button and maintain the position of the programming head over the neurostimulator for the duration of the test Note To stop the electrode impedance test do one of the following Select the CANCEL button Bh Push the red THERAPY STOP key to turn the neurostimulator OFF 6 Review the electrode impedance tes

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