Programming Guide. Neurostimulators for Chronic Pain. RestoreSensor, RestoreUltra, RestoreAdvanced, and PrimeAdvanced

Transcription

1 Progrmming Guide Neurostimultors for Chroni Pin RestoreSensor, RestoreUltr, RestoreAdvned, nd PrimeAdvned For use with SureSn MRI nd erlier non-suresn Neurostimultion Systems.

2 Overview This guide desries mny primry ttriutes of the RestoreSensor, RestoreUltr, RestoreAdvned, nd PrimeAdvned neurostimultion systems nd the model 8840 N Vision progrmmer. Most of the informtion in this guide pertins to oth the SureSn MRI nd erlier non- SureSn neurostimultion systems. Topis tht pply only to the SureSn MRI systems re lerly identified in this guide. This guide does not reple the produt tehnil mnuls. For omplete instrutions, inditions, ontrinditions, wrnings, nd preutions, onsult the produt tehnil mnuls referened on pge 128. Overview The following produts re referened: RestoreSensor SureSn MRI neurostimultor model nd RestoreSensor neurostimultor model (not pitured) RestoreUltr SureSn MRI neurostimultor model nd RestoreUltr neurostimultor model (not pitured) RestoreAdvned SureSn MRI neurostimultor model nd RestoreAdvned neurostimultor model (not pitured) PrimeAdvned SureSn MRI neurostimultor model nd PrimeAdvned neurostimultor model (not pitured) mystim ptient progrmmer models 97740, (not shown), nd (not shown) Externl Neurostimultion System (ENS) (model 37022) N Vision liniin progrmmer (model 8840) Rehrging System (model 37751) 3

3 Tle of Contents Tle of Contents Overview Progrmming Fetures Generl Progrmming Sequene Pin Test Stim Led Connetion Chek RestoreSensor AdptiveStim Orienttion Progrmming AdptiveStim Diry AdptiveStim Tools AdptiveStim Summry Print Reports MyStim : Using AdptiveStim RestoreUltr Diry Dys Limits/Settings RestoreAdvned nd PrimeAdvned Profile Ptient Dt Led Configurtion Led Dt Devie Dt Strt Session Strt Session Diry Groups Diry Dys Mesurement Eletrode Impedne Group Impedne Bttery Test Stim Bttery/Longevity Ativting MRI/CS Mode Progrm MyStim New Group Progrms nd Groups Progrm MyStim Optimizer Using Optimizer TrgetStim Using TrgetStim Limits/Settings Using Limits/Settings TrgetMyStim MyStim Ptient Progrmmer Using TrgetMyStim Return to Cliniin Settings AutoFill Using AutoFill Sheduled Therpy Initil Settings End Session Print Reports Print Sreen End Session Slider Br Session Dt Mnger MyStim Trouleshooting Glossry Referenes Notes. 129 Dislosure. 130 Tle of Contents 4 5

4 Progrmming Fetures Progrmming Fetures Revolutionry dvned progrmming system delivers ese of ptient mngement through the use of menu-driven nvigtion system. AdptiveStim Used to progrm mplitude djustments sed on the position of the ptient (refer to pges 13-45). TrgetStim Used to trnsition eletrode ptterns utilizing interleved pulses nd rmping mplitude to lote effetive therpy (refer to pges 90-93). TrgetMyStim Allows the ptient to move stimultion settings from eletrode to eletrode up nd down the led when using MyStim progrmmer models 97740, nd only (refer to pges nd ). Optimizer Used to quikly refine existing progrms using vritions of the initil progrm eletrode settings (refer to pges 86-89). AutoFill Allows the quik design nd setup of multiple groups nd progrms with only three utton tps (refer to pges ). GroupAdjust Allows the ptient to quikly djust settings t the group level versus historil djustment t the progrm level. Also ville when using ENS model (refer to pges 94-95). Group Nming Allows the liniin to selet Group Nme (ion or text) during the progrmming session. This feture inreses the ptient s ility to identify nd mnge groups. Also ville when using ENS model (refer to pges 82-83). Not ville with RestoreSensor (models nd 37714). Led Connetion Chek (LCC) Used to quikly hek onnetions etween leds, optionl extensions, nd the INS. Aville with MyStim progrmmer models 97740, nd 37744, RestoreSensor neurostimultor (models nd 37714) nd RestoreUltr neurostimultor (models nd 37712) (refer to pges 10 11). Generl Progrmming Sequene Turn the N Vision progrmmer ON. Selet the neurostimultor ion to nvigte to the THERAPY DESKTOP sreen. Hold the progrmming hed stedy over the neurostimultor nd press the PROGRAMMING key. d Aess the PROFILE menu. Enter/review ptient informtion, led onfigurtion, led nd MRI-CS informtion, neurostimultor nd implnt informtion, nd set/review neurostimultor dte nd time. e Aess the START SESSION menu. Review ptient use informtion nd hek the Oservtions ox for signifint system events tht my hve ourred. f Aess the MEASUREMENT menu. Run dignosti tests, review ttery informtion, nd tivte MRI-CS mode. g Aess the PROGRAM MyStim menu. Progrm the devie, rete nd nme groups, identify nd refine stimultion prmeters using TrgetStim, refine stimultion prmeters using Optimizer, nd dd new groups using AutoFill, if desired. h Aess the LIMITS/SETTINGS menu. Selet limits nd settings, enle GroupAdjust nd TrgetMyStim, if desired. i Aess the END SESSION menu. Verify tht ll settings re orret nd end the session. Progrm Button One you hve entered new prmeters or settings into the progrmmer, press the Progrmming P key or selet the Progrm utton on the sreen to send or progrm your hnges to the implnted devie. If you hve pending prmeters, you will e unle to hnge sreens until you hve progrmmed the new prmeters. Generl Progrmming Sequene 6 7

5 Pin Test Stim Pin Test Stim To progrm for intropertive sreening or postopertive test stimultion, the model Externl Neurostimultor (ENS) is onneted to the model 8840 Cliniin Progrmmer. The model 8870 pplition rd provides the softwre to progrm the ENS for these proedures. Sreening nd test stimultion options re ville fter initil interrogtion nd ENS identifition. Note: When using the ENS for intropertive sreening or postopertive test stimultion, the N Vision progrmmer softwre tkes pproximtely 60 seonds to lod. Intropertive Selet for intropertive sreening with miniml progrmming pilities (i.e., single group, eletrode, nd group impedne mesurements). Previous session informtion not retined My e used to identify optiml led position New Selet for new test stimultion with full progrmming pilities. Previous session informtion not retined My e used to set up nd ondut tril Follow-up Selet for test stimultion follow-up with full progrmming pilities. Previous session informtion retined My e used for reprogrmming during tril or t the ompletion of tril Note: If the leds implnted for tril sreening re lso intended for fully implnted neurostimultion system fter the tril sreening period, the following pplies: - Selet New (not Intropertive) from the TestStim seletion sreen. - Use the Notes field to enter the led model numers nd led tip lotions into the ENS. - Print the temporry session report in the Session Dt Mnger for reord of the led implnt informtion. The led implnt informtion will e needed t the time of full system implnt. Corret nd up-to-dte omponent informtion for the fully implnted system estlishes MRI onditionlly sfe (MRI-CS) sn eligiility. Pin Test Stim 8 9

6 Led Connetion Chek (LCC) The Led Connetion Chek feture hs een dded to the dignosti sreens of the models 97740, nd MyStim progrmmer nd is ville when used with RestoreSensor (models nd 37714) nd RestoreUltr (models nd 37712) neurostimultion systems. During the RestoreSensor nd RestoreUltr neurostimultion system implnts, the models 97740, nd MyStim progrmmer my e used to quikly hek onnetions etween the leds, optionl extensions, nd INS. Using Led Connetion Chek (LCC): d Led Connetion Chek (LCC) Turn the MyStim ptient progrmmer ON. Simultneously press nd hold the Inrese Derese keys. nd The Led Connetion Chek sreen will disply. d Ple the MyStim progrmmer over the INS nd press the Syn key to initite the led onnetion hek. Note: The Communition sreen will e displyed while the LCC sreen is in progress. e When the Led Connetion Chek is omplete, the numer of onneted eletrodes will e displyed. Note: If the numer of eletrodes shown does not orrespond with the numer expeted or to hek the impedne of these onnetions, use the N Vision liniin progrmmer. d Led Connetion Chek (LCC) e

7 RestoreSensor RestoreSensor This setion outlines softwre hrteristis unique to the RestoreSensor (models nd 37714) neurostimultion system. All other fetures re similr to those ville with RestoreUltr (models nd 37712), RestoreAdvned (models nd 37713), nd PrimeAdvned (models nd 37702) neurostimultion systems (see pges ). AdptiveStim Use to djust mplitudes utomtilly when the ptient hnges position or tivity level while in the upright position. Amplitude settings n e defined for ny or ll of the following six positions supported y RestoreSensor: Stnding or sitting upright Lying on your k Lying on your front Lying on your right side Lying on your left side Moile while upright RestoreSensor AdptiveStim When AdptiveStim is enled, ptient mplitude djustments nd the ssoited position re reorded y the neurostimultor. This informtion is downloded from the neurostimultor nd is ville from the AdptiveStim Diry sreens on the liniin progrmmer

8 RestoreSensor Orienttion RestoreSensor Orienttion Orient the neurostimultor: The neurostimultor needs to e oriented efore using AdptiveStim. Orienting the neurostimultor will turn the AdptiveStim Diry on. Refer to pge 22 for AdptiveStim Diry fetures. Aess the Progrm MyStim menu nd selet Orienttion. Choose position nd ple the ptient in the orresponding position. Selet the Orient utton. When the neurostimultor hs een oriented in position, hekmrk will pper on the progrmmer sreen. Repet until the neurostimultor hs een oriented for eh position. After the lst position hs een oriented, the neurostimultor will turn on the AdptiveStim Diry fetures. RestoreSensor Orienttion 14 15

9 RestoreSensor Progrmming There re 3 wys AdptiveStim n e enled nd progrmmed: Method Enle AdptiveStim AdptiveStim Therpy Ptient-Defined On AdptiveStim sreen Defined y ptient t home. Cliniin- Defined On AdptiveStim sreen Defined y liniin on Progrm MyStim sreen with ptient le to override therpy t home. Amplitude Trend On Amplitude Trend sreen Defined dt previously reorded while ptient ws t home. Aept reorded dt on Amplitude Trend sreen to progrm AdptiveStim. Method 1: Ptient-Defined Use if ptient is willing nd le to use the AdptiveStim feture. The AdptiveStim feture n e enled for one or more groups nd positions from the AdptiveStim sreen. RestoreSensor Progrmming Complete neurostimultor orienttion: Aess the Progrm MyStim menu nd selet AdptiveStim. Selet group. Selet position. Note: To selet positions for speifi group, selet the group from the drop-down list. All positions within the group will e enled for AdptiveStim y defult. Enled positions will hve hek in the ox next to the nme of the position. To disle position, unhek the pplile ox. Repet for dditionl groups. d Press Progrmming P key or selet the Progrm utton on the progrmmer sreen. Note: Send the ptient home nd s they djust mplitude in different positions with their MyStim progrmmer, the neurostimultor will rememer nd utomtilly pply those mplitude settings the next time the ptient ssumes those positions. d 16 17

10 RestoreSensor Progrmming Method 2: Cliniin-Defined Use to define positions with mplitudes for the ptient one AdptiveStim hs een enled. Complete neurostimultor orienttion nd enle AdptiveStim (s outlined in the Ptient-Defined method on pge 16): Aess Progrm MyStim menu nd selet Progrm MyStim. Selet n AdptiveStim group from the drop-down list. Ativte tht group if needed. d Selet new mplitude using the rrow uttons or y seleting the mplitude input ox to enle sroll wheel djustments. e Selet the Positions utton. f Selet positions. Selet the positions to e defined. Seleting positions ssigns the mplitudes on the previous sreen to these positions. g Press Progrmming P key or selet the Progrm utton on the progrmmer sreen. send ptient home. Amplitude settings will utomtilly djust with his or her position hnges. d e f Note: To view speifi mplitudes for defined positions, selet the desired position from the View Defined Position drop-down menu from the Progrm MyStim sreen. These mplitudes n e progrmmed y seleting the tivte utton. g 18 19

11 RestoreSensor Progrmming Method 3: Amplitude Trend Use if unsure of ptient enefit from AdptiveStim. Note: Send the ptient home nd let him or her use the MyStim progrmmer to djust mplitude settings in different positions. The neurostimultor will reord the minimum nd mximum mplitudes used in eh position. When the ptient returns in lini, the reorded settings n e viewed nd progrmmed from the Amplitude Trend sreen. Aess Strt Session menu nd selet Amplitude Trend to review the minimum nd mximum mplitudes the ptient hs used in eh position. Note: All positions within the group will e enled for AdptiveStim y defult. Enled positions will hve hek in the ox next to the nme of the position. To disle position, unhek the pplile ox. Repet for dditionl groups. To view the Amplitude Trend dt for different group, selet the group from the drop-down list. One review is omplete, press Progrmming P key or selet the Progrm utton on the progrmmer sreen to enle AdptiveStim for the seleted group nd define the seleted positions with mplitudes RestoreSensor Progrmming

12 RestoreSensor AdptiveStim Diry The AdptiveStim Diry inludes the following informtion: Adjustment Summry (this pge) Position Trend (pge 24) Amplitude Trend (pge 26) Resting Trend (pge 28) Adjustment Summry Use to review the numer of mplitude djustments the ptient mde while in eh position. Aess the Strt Session menu nd selet Adjustment Summry. Review the numer of djustments the ptient hs mde to mplitude for ll groups. Selet group to view the numer of mplitude djustments mde for speifi group. RestoreSensor AdptiveStim Diry 22 23

13 RestoreSensor AdptiveStim Diry Position Trend Use to review verge perentge of time eh dy the ptient ws in eh position. Perentges re the verge of ll dys sine the lst progrmming session. Averges for the lst four progrmming sessions (inluding the urrent session) re given. Aess Strt Session menu nd selet Position Trend. Review the verge perentge of time the ptient ws in eh position from the r hrt. Selet the View Detils utton to view Position Trend detil

14 RestoreSensor AdptiveStim Diry Amplitude Trend Use to review the minimum nd mximum mplitude vlues the ptient used when djusting mplitudes for eh position within eh group. Aess Strt Session menu nd selet Amplitude Trend. Review the minimum nd mximum mplitudes the ptient hs used in eh position. Note: All positions within the group will e enled for AdptiveStim y defult. Enled positions will hve hek in the ox next to the nme of the position. To disle position, unhek the pplile ox. Repet for dditionl groups. Review the Amplitude Trend dt for different group, selet the group from the drop-down list

15 RestoreSensor AdptiveStim Diry Resting Trend Use to review the verge numer of trnsitions per dy the ptient hnged from one lying position to nother. Averges re for ll dys sine the lst progrmming session. Dtes re given for the lst four progrmming sessions (inluding the urrent session). Aess Strt Session menu nd selet Resting Trend. Review the r hrt showing the verge numer of position hnges while lying. RestoreSensor AdptiveStim Diry 28 29

16 Using AdptiveStim Tools Using AdptiveStim Tools AdptiveStim Tools n e used to trouleshoot nd modify AdptiveStim position settings. The following AdptiveStim tools re ville: Trnsition Time Chnges the mount of time tht must elpse etween position hnges efore the position-speifi mplitude will hnge. Different settings re ville for vriety of position trnsitions. Moility Rte Chnges the rte/speed of movement (or moility) tht is onsidered hnge from the sttionry Upright position to the Moile while Upright position. A sliding sle hnges the rte/speed from low to high. Position Rnge Chnges the re overed y Lying position or Upright position. The rnge or re of Lying or Upright position n e set to extr-extr smll (XXS), extr smll (XS), smll (S), medium (M), lrge (L), extr lrge (XL), or extr-extr lrge (XXL). Chek Position Displys the ptient position eing registered y the neurostimultor. Test AdptiveStim Tests urrent AdptiveStim settings (position mplitudes, trnsition settings, nd/or position rnges) nd llows ptient feedk on settings. Reset Orienttion Erses urrently-oriented positions ut retins AdptiveStim groups, positions, nd position-speifi mplitudes. After resting orienttion, positions must e re-oriented from the ORIENTATION sreen in order to enle AdptiveStim gin. RestoreSensor Trouleshooting Prolem The dely etween position hnge nd the mplitude hnges is too slow or too fst for the ptient. The mplitude hnges too often for the ptient. The mplitude hnges to the mplitude for the Moile while Upright position while the ptient is in the Upright position ut not moile. The neurostimultor my hve rotted or flipped within the poket. The ptient feels the mplitude for the Upright position when they wnt to feel the mplitude for the Lying position. The mplitudes for vrious positions do not meet ptient stimultion needs. Possile Tool nd Solution Use the trnsition time settings to inrese or derese the dely etween position hnges nd mplitude hnges. Use Test AdptiveStim to otin ptient feedk nd mke djustments s needed. Use trnsition time to inrese the dely etween position hnge nd mplitude hnge. Use moility rte to inrese the intensity of movement required for therpy to hnge to mplitude for Moile while Upright position. Hve the ptient remin still for t lest one minute. Use the Chek Position feture to onfirm their position. Use Reset Orienttion to erse urrent orienttion mesurements without losing position-speifi mplitudes. Use the Orienttion sreen to otin new orienttion mesurements nd enle AdptiveStim. Use position rnge to inrese the lying re. Define mplitudes for ptient in different positions nd use the Test AdptiveStim feture to try nd hek in the lini

17 RestoreSensor AdptiveStim Tools Modify Trnsition Settings: Aess the Mesurement Menu nd selet Trnsition Settings. Selet the desired time for the position trnsitions. Press Progrmming P key or selet the Progrm utton on the progrmmer sreen. d Selet the Strt utton to test new trnsition times s needed. Modify Position Rnge: Aess the Mesurement menu nd selet Position Rnge. Selet pplile rnges from the drop-down lists. Press Progrmming P key or selet the Progrm utton on the progrmmer sreen. d Selet the Strt utton to test new rnges s needed. d d 32 33

18 RestoreSensor AdptiveStim Tools Modify Trending Options: Aess the Mesurement menu nd selet Trending Options. Selet or de-selet Amplitude Trend nd Position Trend options. Note: - Seleting nd de-seleting Amplitude Trend ffets Amplitude Trend nd Adjustment Summry. - Seleting nd de-seleting Position Trend ffets oth Position Trend nd Resting Trend. - If AdptiveStim is enled then Amplitude Trend nnot e disled. Use the rdio uttons to selet AdptiveStim on or off t the end of the progrmming session. d Press Progrmming P key or selet the Progrm utton on the progrmmer sreen. Chek Position: Aess the Mesurement menu nd selet Position Rnge. Selet the Chek Position utton to verify position. d Reset Orienttion: Aess the Mesurement menu nd selet Position Rnge. Selet the Reset Orienttion utton nd onfirmtion sreen will pper. Selet the OK utton on tht sreen. Previous orienttion vlues will e deleted nd the Orienttion sreen will pper

19 RestoreSensor AdptiveStim Tools Test AdptiveStim Settings: Aess the Mesurement Menu nd selet Trnsition Settings or Position Rnge under AdptiveStim Tools. Selet the Strt utton nd hve the ptient hnge positions nd provide feedk on stimultion hnges. Note: When using the Test AdptiveStim feture, the following trnsition times pply. The trnsitions times listed elow re defult vlues. - Upright position to Lying position: 0 seonds - Lying position to nother Lying position: 0 seonds - Lying position to Upright position: 20 seonds - Upright position to Moile position: 2 minutes - Moile position to Upright position: 2 minutes Selet the Stop utton to end the test. RestoreSensor AdptiveStim Tools 36 37

20 RestoreSensor AdptiveStim Summry Review Progrmmed Settings: Selet End Session nd review settings. Selet AdptiveStim Summry utton to review AdptiveStim settings. Selet the desired group to view orresponding AdptiveStim settings. RestoreSensor AdptiveStim Summry RestoreSensor AdptiveStim Summry 38 39

21 RestoreSensor Print Reports Print Reports The informtion ontined in the Summry, Groups, nd Mesurements reports is sved s single session dt file in the Session Dt Mnger nd nmed with the ptient session nme. The following reports n e seleted for printing, depending on whether dt exist for the report. Summry report neurostimultor dt nd history. AdptiveStim report informtion on ll AdptiveStim settings nd AdptiveStim Diry informtion. Groups report groups nd progrm informtion. Mesurements report ttery informtion nd results from the eletrode impedne test nd group impedne test. MyStim Diry report group use dt sine the lst session. Ptient report (to e given to the ptient) informtion on ptient settings, ville ptient ontrol limits, nd Sheduled Therpy. (Note: Sheduled Therpy is not ville with RestoreSensor.) MDT Dt report dt tht n e provided to Medtroni Tehnil Servies (this report is seprte file in the Session dt mnger). MRI-CS report - MRI onditionlly sfe (MRI-CS) sn eligiility for the implnted neurostimultion system. All Reports - ll reports re seleted for printing. To print report during the session: Ensure the printer is ON. Move the progrmmer to within 1 meter (3.3 feet) of the printer, with the printer nd progrmmer IR ports diretly fing eh other. Selet Print Reports from the End Session Menu. Selet the hekox next to the desired reports on the list. Selet the Print utton. Note: A printout of the finl settings should e pled in the ptient file. You n print sved session reports from the Session Dt Mnger, or print urrent settings ny time during the progrmming session RestoreSensor Print Reports

22 MyStim: Using AdptiveStim Note: AdptiveStim is ville only with MyStim progrmmer models nd AdptiveStim groups nd positions The liniin n progrm speifi mplitudes for eh of the six positions, or the liniin n progrm AdptiveStim to dpt the mplitude settings sed on the djustments the ptient mkes to the stimultion while in one of the positions. AdptiveStim reognizes these six positions: Using AdptiveStim If the liniin hs progrmmed AdptiveStim nd AdptiveStim is turned on, the AdptiveStim On ion ( A ) will pper in the Sttus row on the THERAPY sreen. Sttus row Stnding or sitting upright Lying on your k lying on your front Lying on your right side Lying on your left side Moile while upright AdptiveStim position nmes (revited text or the AdptiveStim ion) re displyed on the Group row of the THERAPY sreen. AdptiveStim position ions re displyed on the Prmeter row. AdptiveStim ON ion - if AdptiveStim is on nd the therpy is on, the mplitude settings will hnge utomtilly in response to the ptient s position hnges. - if AdptiveStim is turned off, only the Neurostimultor On ion ( ) nd Neurostimultor Off ion ( ) will disply in the upper left orner of the Sttus row. - dptivestim must e turned on in order to view AdptiveStim informtion on the THERAPY sreen. Mking djustments to AdptiveStim If the ptient mkes n djustment to the stimultion with AdptiveStim on nd wnts to hve tht djustment rememered for ertin position, the ptient should: - mke the djustment nd, - sty in tht urrent position for t lest three minutes. Note: If the ptient hnges position while inresing or deresing the stimultion mplitude, the AdptiveStim ion or text will link, inditing the ptient progrmmer hs updted to the urrent AdptiveStim position. Position nme MyStim: Using AdptiveStim Position ion Note: If the ptient hnges positions fter synhronizing, resynhronize in order to view updted positions nd settings

23 MyStim: Using AdptiveStim Turning AdptiveStim on nd off Complete the following steps to turn AdptiveStim on or off. 1. synhronize the MyStim progrmmer nd neurostimultor.. hold the MyStim progrmmer diretly over the neurostimultor with the sreen fing outwrd.. Press the SYNC key. The THERAPY sreen ppers. AdptiveStim On 4. Press the SYNC key to send the hnge to the neurostimultor nd return to the THERAPY sreen. AdptiveStim Off MyStim: Using AdptiveStim 2. Press the up s rrow on the NAVIGATOR key to move the seletion ox to the Sttus row. 3. Press the right rrow on the NAVIGATOR key to move the seletion ox to the AdptiveStim preferene. s Note: The preferene sreen displys the AdptiveStim stte tht the ptient will hnge to. For exmple, if AdptiveStim is urrently turned on, the AdptiveStim Off ion will e displyed on the preferene sreen. Note: With the AdptiveStim off, the ptient will not see the AdptiveStim On ion, position nme next to the Group, or position ion

24 RestoreUltr RestoreUltr This setion outlines softwre hrteristis unique to the RestoreUltr (models nd 37712) neurostimultion system. All other fetures re similr to those ville with RestoreAdvned (models nd 37713) nd PrimeAdvned (models nd 37702) neurostimultion systems (see pges ). RestoreUltr Progrms nd Groups The RestoreUltr neurostimultion system hs the pity for up to eight (8) groups (A-H); eh group n hve up to four (4) progrms. A mximum of 16 progrms re ville. Prmeter Settings Some RestoreUltr prmeter setting rnges hve een inresed: Amplitude* ( ) : V with 0.05-V or 0.1-V resolution Pulse Width* ( ): µs (10-µs resolution) Rte* ( ): 1 progrm: Hz 2 progrms: Hz 3 progrms: Hz 4 progrms: Hz *Assuming no other limittions due to high rte, pulse width, nd mplitude. One eletrode my e tive in more thn one progrm within group. When more thn one eletrode is shred y more thn one progrm, ertin restritions re pplied to prevent group rte nd pulse width upper limits from exeeding 260 Hz for rte or 450 µs for pulse width. Note: Group rte is lulted y multiplying the rte y the numer of progrms in tht group. Group pulse width is the highest pulse width mong ll progrms in tht group. RestoreUltr Progrms nd Groups 46 47

25 RestoreUltr Diry Dys RestoreUltr Diry Dys Use to review ptient use dt olleted etween sessions. To view more detiled ptient use dt for speifi dy, selet the dy on the lendr. No Dt Aville will e displyed if there is no diry informtion ville. Dy Detils sreen Displyed when speifi dy is seleted. Used to review tive groups, numer of ptient djustments, nd stimultion ON periods for speifi time periods of the dy. Previous nd Next uttons selet to view ptient use dt for the previous or next lendr dy. RestoreUltr Diry Dys 48 49

26 RestoreUltr Limits/Settings RestoreUltr Limits/Settings Note: Limits nd Settings options for the RestoreUltr neurostimultion systems re slightly different from those of RestoreAdvned nd PrimeAdvned systems. Group Seletion utton Selet to hoose ville group(s). Note: If the A-H option is seleted, the setting will e progrmmed to pply to ll existing nd new groups. Limit Types Selet to hoose options for eh stimultion prmeter. Limit type Full Rnge Customize Off Definition The ptient is le to djust the vlue for the seleted stimultion prmeter within the entire rnge provided y the neurostimultor. Cliniin-set limits (ustom or trking) re progrmmed. The ptient is le to djust the vlue for the seleted stimultion prmeter within these limits. The ptient is not le to djust the vlue for the seleted stimultion prmeter. Limit Vlue oxes (for setting ptient ontrol limits) Aville only if liniin-set limits re progrmmed (i.e., Customize rdio utton seleted). Selet to set mplitude, pulse width, nd rte upper nd lower limit vlues. d GroupAdjust hekox Selet to enle the GroupAdjust feture. Note: This feture llows the ptient to inrese or derese ll progrm mplitudes in the tive group t the sme time using the MyStim progrmmer. Also ville with ENS model e TrgetMyStim utton Selet to ess the TrgetMyStim sreen nd enle/disle TrgetMyStim for individul groups. Amplitude Lower Limit must e set to 0.0 V for eh progrm. Note: This feture llows the ptient to move stimultion settings from eletrode to eletrode up nd down the led using the MyStim progrmmer (refer to pges nd ). f SoftStrt/Stop hekox Selet to slowly inrese the mplitude when the neurostimultor is turned ON nd slowly derese the mplitude when hnging groups, yling, or during sheduled therpy group trnsitions/ hnges. g SoftStrt/Stop input ox Selet to set SoftStrt/Stop vlue. h Cyling hekox Selet to turn the neurostimultor ON nd OFF t liniindetermined intervls (i.e., 0.1 seond to 30 minutes) d f h e g f h g RestoreUltr Limit/Settings

27 RestoreAdvned nd PrimeAdvned This setion outlines fetures ville with RestoreAdvned (models nd 37713) nd PrimeAdvned (models nd 37702) neurostimultion systems. These fetures re lso ville with the RestoreSensor (models nd 37714) nd RestoreUltr (models nd 37712) neurostimultion systems, unless otherwise noted. RestoreAdvned nd PrimeAdvned Progrms nd Groups RestoreAdvned nd PrimeAdvned neurostimultion systems hve the pity for up to 26 groups (A-Z); eh group n hve up to four (4) progrms. A mximum of 32 progrms re ville. Prmeter Settings Amplitude ( ) : V with 0.05-V or 0.1-V resolution RestoreAdvned nd PrimeAdvned Pulse Width ( ): µs (10-µs resolution) Rte ( ): 1 progrm: Hz 2 progrms: Hz 3 progrms: 2-85 Hz 4 progrms: 2-65 Hz RestoreAdvned nd PrimeAdvned 52 53

28 Profile Ptient Dt Ptient Dt Use for first-time setup of ptient informtion displyed ross other sreens. Informtion is stored in the implntle neurostimultor (INS) nd/or externl neurostimultor (ENS) for future use. Ptient ID Selet to enter ptient nme, ID numer, or ny other pproprite informtion. Ptient Dignosis Touh to selet ptient dignosis from the dropdown list or selet the field to enter nother dignosis. Physiin Informtion Selet to enter physiin nme, phone numer, or ny other pproprite informtion. d Notes Touh to open Notes sreen nd enter ny desired informtion. e Ptient Session Nme Displys neurostimultor seril numer. Also displys ptient nme if entered on the Ptient Dt sreen. d Ptient Dt e 54 55

29 Led Configurtion Use for first-time setup of devie onfigurtion informtion displyed ross other sreens. Informtion is stored in the implntle neurostimultor (INS) nd/or externl neurostimultor (ENS) for future use. Led Configurtion Led Configurtion Touh to selet the pproprite led onfigurtion from the drop-down list. Note: Configurtions in the drop-down list with prentheses ( ) round them represent surgil leds. A forwrd slsh / indites the leds re seprted in the ody nd nnot e progrmmed together using the TrgetStim feture. Led Nme fields If pproprite, selet to enter led nmes. Eletrode Numering drop-down lists If pproprite, selet to renumer the eletrodes. d Flip Leds Vertilly utton If pproprite, selet to flip the led orienttion nd touh to renumer the eletrodes using the dropdown list(s). Note: If led onfigurtion or orienttion is hnged during reprogrmming session, ll groups nd progrms ssoited with the originl onfigurtion will e deleted. d Led Configurtion 56 57

30 Led nd MRI-Conditionlly Sfe (MRI-CS) Dt Led nd MRI-CS Dt Use for first-time setup of led lotion informtion. Informtion is stored in the implntle neurostimultor (INS) nd/or externl neurostimultor (ENS) for future use. Note: A Prohiited ( ) symol ppers next to ll lnk entries on the Led & MRI-CS Dt sreen. The symol disppers when dt is entered tht llows full-ody eligiility for MRI sns. From the Profile menu Selet Led & MRI-CS Dt. Devie Lotion Selet neurostimultor implnt lotion from the Devie Lotion drop-down list. If the implnt lotion is not ville on the dropdown list, you my enter it mnully. Mnully-entered implnt lotions will lwys show the Prohiited symol. Led Model Numer Enter led model numers in the Led Model No. fields. You my mnully enter the led model numers, or selet previously-entered model numers from the drop-down list. d Led Tip Lotion Selet the Led Tip Lotion from the drop-down list e Extensions Selet the pproprite Extensions utton to indite whether No, 1, or 2 extenstions were used. If you selet 1 or 2 extensions, n Extension model field will pper, llowing you to enter the model numer for eh extension. f Andoned Pin Leds Selet Yes or No to indite whether ny ndoned pin leds or extensions remin in the ptient. g Progrm Button Hold the progrmming hed stedy over the neurostimultor, then press the Progrmming key (on the left side of the N Vision progrmmer) or selet the Progrm (P) utton on the progrmmer sreen. At this point, the dt entered on this sreen is progrmmed into the neurostimultor, MRI-CS mode is tivted, nd the MRI-CS Mode sreen displys. h Review Review the MRI-CS Mode sreen for the MRI-CS sn eligiility nd selet the OK utton to resume the progrmming session while in MRI-CS mode. MRI-CS mode n e detivted y turning stimultion on. Refer to Ativting MRI-CS Mode on pge 76 for dditionl informtion out the MRI-CS Mode sreen. d e f g Wrning: Before explnting nd repling n existing neurostimultor, print report from the existing neurostimultor tht shows implnted nd ny ndoned omponent informtion. When dding, hnging, or removing neurostimultors, leds, extensions, nd essories, lwys progrm up-to-dte omponent model numers, implnt lotions, nd ny ndoned omponent informtion to re-estlish MRI-sn eligiility. If this informtion is not updted or is entered inorretly, MRI onditionlly sfe (MRI-CS) sn eligiility dt will e inurte, nd the ptient is t risk for one of the following: The ptient is llowed to hve n MRI sn inpproprite for the implnted omponents, whih ould use tissue heting, resulting in tissue dmge or serious ptient injury. The ptient is unneessrily restrited from hving n MRI sn. Led nd MRI-CS Dt 58 59

31 Devie Dt Informtion is stored in the implntle neurostimultor (INS) nd/or externl neurostimultor (ENS) for future use. Dte nd Time View the urrent system dte nd time stored in the neurostimultor. To reset the dte nd time, selet the input ox nd use the Inrese nd Derese uttons or selet the Mth N Vision utton on the Dte nd Time sreen. Lotion Touh to selet the neurostimultor implnt lotion from the Lotion drop-down list or to enter nother lotion. Note: For SureSn MRI neurostimultors, the Lotion field is loted on the Led & MRI-CS Dt sreen (s shown on pges 58-59). Implnttion Dte Selet to enter the dte the neurostimultor ws implnted. d Aout Devie Selet to view informtion out the N Vision progrmmer, INS, nd MyStim progrmmer. RestoreAdvned Rehrgele neurostimultor d Devie Dt d Devie Dt PrimeAdvned Nonrehrgele neurostimultor 60 61

32 Strt Session Strt Session Strt Session Displys urrent settings inluding initil settings, tive group, MyStim Diry, nd generl use informtion. This sreen is for informtion only; prmeters nnot e progrmmed from this sreen. Ative Group Displys the group tht is urrently providing therpy. Aville Groups Displys the initilly interrogted numer of groups. Use (%) Displys the perentge of neurostimultor ON time sine the lst follow-up session. d Group Usge Displys r grph presenttion of the perentge of neurostimultor ON time for the ville groups. If no groups re progrmmed, No Dt Aville will e displyed. e Bttery/Servie Life Displys ttery/servie life sttus. f Oservtions Selet to view dditionl informtion out n item in the oservtions ox. Py speil ttention to system lok, EOS (End of Servie), nd ERI (Eletive Replement Inditor) notifitions. Notes: RestoreAdvned Rehrgele neurostimultor d e f d Strt Session Initil informtion n e viewed throughout the progrmming session on the Strt Session sreen. Progrmming hnges mde during the session re not updted on the Strt Session sreen. e PrimeAdvned Nonrehrgele neurostimultor f 62 63

33 Diry Groups Use to review ptient use dt olleted etween sessions. Sort By Selet to sort the displyed dt y Group or y Usge. Note: No Dt Aville will e displyed if there is no diry informtion ville. Diry Groups Diry Groups 64 65

34 Diry Dys Use to review ptient use dt olleted etween sessions. To view more detiled ptient use dt for speifi dy, selet the dy on the lendr. No Dt Aville will e displyed if there is no diry informtion ville. Dy Detils sreen Displyed when speifi dy is seleted. Used to review tive groups, numer of ptient djustments, nd stimultion ON periods for speifi time periods of the dy. Previous nd Next uttons Selet to view ptient use dt for the previous or next lendr dy. RestoreAdvned Rehrgele neurostimultor Note: For Diry Dys informtion, refer to pges for RestoreSensor nd pges for RestoreUltr. PrimeAdvned Nonrehrgele neurostimultor Diry Dys Diry Groups 66 67

35 Mesurement Eletrode Impedne Use to hek eletrode impedne nd system integrity. Amplitude Vlue drop-down list Selet n mplitude vlue from the drop-down list. Aville options inlude 0.25 V, 0.70 V, 1.5 V, nd 3.0 V. Eletrode Impedne Mesurement utton Selet to test ll eletrode omintions. Out-of-Rnge Results Review results to detet potentil issues with system integrity (e.g., short iruit, open iruit). d Referene Touh to selet referene eletrode from the drop-down list. e Eletrode Impedne Results Review the eletrode impedne test results ny time during the session. d Eletrode Impedne e Eletrode Impedne 68 69

36 Group Impedne Group Impedne Use to hek group impedne nd system integrity. Group Impedne Mesurement utton Selet to test the impedne for the seleted group. Group Impedne Touh to selet group from the drop-down list. Group Impedne Results View the impedne nd urrent mesurement for the seleted group. Note: Test results n e viewed t ny time during the progrmming session. Group Impedne 70 71

37 Bttery Bttery Use to hek ttery nd/or rehrge sttus. Neurostimultor informtion Review the implnted neurostimultor ttery level sttus nd ttery servie life (e.g., OK, ERI, or EOS). Rehrge informtion (for RestoreAdvned, RestoreUltr nd RestoreSensor rehrgele neurostimultors only) Review the implnted neurostimultor ttery rehrge informtion sine the lst progrmming session. Chrge Detils (for RestoreAdvned, RestoreUltr nd RestoreSensor rehrgele neurostimultors only) review detils of the lst six rehrge sessions inluding durtion of rehrge session nd ttery hrge level t the end of the rehrging session. Note: In order to retin this informtion, ess the End Session menu nd selet Print Sreen. RestoreAdvned Rehrgele neurostimultor Bttery PrimeAdvned Nonrehrgele neurostimultor 72 73

38 Test Stim Bttery/Longevity Feture ONLY ville when using Externl Neurostimultion System (ENS) model Used to estimte longevity of implntle devies sed on therpy settings urrently progrmmed in the ENS. Group Seletion drop-down list Selet group from the list of ville groups. Estimted Longevity View ttery/longevity estimtes sed on ptient usge dt. Bttery/Longevity Results utton Selet to run longevity estimtes. Test Stim Bttery/Longevity Test Stim Bttery/Longevity

39 Ativting MRI-CS Mode You n prepre ptient s neurostimultion system for n MRI sn y pling it in MRI onditionlly sfe (MRI-CS) mode prior to the MRI sn ppointment. 1. From the Profile menu, selet Led & MRI-CS Dt. Confirm tht the implnted omponent nd implnt lotion informtion is urrent nd urte. Note: If the implnted omponent nd implnt lotion informtion is not omplete nd urte, the resulting MRI-CS sn eligiility my e inorret. 2. From the Mesurement menu, selet MRI-CS Mode. This tivtes MRI-CS mode, turns stimultion off, nd displys one of the following MRI-CSsn eligiility results: Inform the ptient of the following: When MRI-CS Mode is tivted, stimultion is turned off. Stimultion must e off during the MRI sn. Beuse stimultion is off, pin symptoms my return. After the MRI sn is omplete nd the ptient is outside of the mgnet room, stimultion n e turned k on using the ptient progrmmer. Or, if pproprite, the ptient n revisit you fter the MRI sn to hve stimultion turned k on with the liniin progrmmer. Note: You n detivte MRI-CS mode y turning stimultion on using the liniin or ptient progrmmer. Ativting MRI-CS Mode Full Body Eligile Hed-Only Eligile Eligiility Cnnot e Determined 3. Review the MRI-CS sn eligiility result displyed on the MRI-CS Mode sreen nd omplete the MRI Ptient Eligiility Form (whih n e otined from your Medtroni representtive). 4. Provide the ompleted MRI Ptient Eligiility Form to the ptient or to the rdiologist performing the MRI sn. Ativting MRI-CS Mode 76 77

40 Progrm MyStim New Group New Group Use to dd new groups to provide dditionl therpy options for your ptient. Group Seletion drop-down list Selet to hoose n ville group. Undefined Progrms ts Selet to dd new progrm of stimultion. Progrm Types drop-down list Selet to hoose progrm type from the predefined list. d Progrm drop-down list nd sroll uttons Selet to hoose progrm from the list of ville progrms. e Eletrodes Selet the eletrode -, +, or lnk (OFF) options on the led to e progrmmed. f Amplitude input ox Touh to selet trget vlue or to hnge the mplitude resolution. g Stop Amplitude Rmp utton Selet to stop the mplitude t new trget vlue while it is rmping. h Pulse Width input ox Touh to selet trget vlue from the list of vlues tht pper in the vlue window. Cution: To prevent possile unomfortle or unexpeted stimultion (jolting or shoking senstion), derese the mplitude to the pereption threshold (the mplitude t whih the ptient first pereives presthesi) efore hnging the pulse width. After hnging the pulse width, slowly inrese the mplitude. i Rte input ox Touh to selet trget vlue from the list of vlues tht pper in the vlue window. e d f g h i New Group 78 79

41 Progrms nd Groups The primry gol of progrmming is to superimpose the stimultion or presthesi pttern over the ptient s pin pttern nd to estlish the orret stimultion prmeter vlues. Progrm A speifi omintion of pulse width, rte, nd mplitude settings ting on speifi eletrode omintion. Multiple progrms n e used to mximize pin overge. When using more thn one progrm, the pulses re delivered sequentilly. Group A Progrms nd Groups Group A olletion of up to 4 progrms delivered sequentilly. Rte remins onstnt ross ll progrms in group. My e used to provide therpy for speifi res of overge or speifi ptient tivities. Note: Refer to pge 47 for RestoreUltr progrms nd groups informtion. Refer to pge 53 for RestoreAdvned nd PrimeAdvned progrms nd groups informtion. Group A Right Leg & Low Bk Pin Progrm 1 Right Leg & Low Bk Pin Left Leg & Low Bk Pin Progrm 1 Progrm 2 Group Progrmming Exmples: 1 Group with 1 Progrm (2 x 8) Simple, single lim nd low k pin. Use of 1 progrm (with 2 leds) to over lim pin nd low k pin. 1 Group with 2 Progrms (2 x 8) Dul lim nd low k pin. Use of 2 progrms to mximize pin overge. One progrm ould hve higher mplitude to intensify the presthesi on one side. 2 Groups with Progrms in eh Group (2 x 8) Primry single lim nd low k pin; osionl dul lim nd low k pin. Use of 2 groups independently to ddress pin needs (either speifi res of pin or for speifi tivities). Group A Group B Right Leg & Low Bk Pin Progrm 1 Progrms nd Groups Benefit: Ptient onveniently nd effetively selets pproprite therpy. Right Leg Pin Left Leg Pin Low Bk Pin Progrm 1 Progrm 2 Progrm

42 Progrm MyStim Use to progrm devie prmeters inluding eletrode polrity, mplitude, pulse width, nd rte on up to 4 progrms of stimultion. This sreen llows the user to view group nd its orresponding progrms nd prmeters t glne. Group Seletion drop-down list Selet to move etween ville groups. Note: A group must e tive to rete/modify progrms. Ative Group t Selet to return to the tive group settings or to selet new group. Progrm ts Selet to review/modify prmeters. d Group Nme drop-down list Selet to hoose nme for the group from the drop-down list. e d f Progrm MyStim Note: Group nmes seleted during progrmming will e ville to the ptient s ions or text when they use their MyStim progrmmer. If no nme is seleted, letter (e.g., A, B, C) will e used s the group nme on the MyStim progrmmer. Also ville with ENS model Not ville with RestoreSensor. e Chekoxes To temporrily set the mplitude to 0.0 V, selet the hekox next to the progrm ion so the hek mrk is removed. Note: To retivte the previous mplitude for the progrm, selet the hekox gin. f Progrm Amplitude Adjustment uttons Selet to set the desired mplitudes for eh progrm

43 Progrm MyStim Group Seletion drop-down list Selet to move etween ville groups. Note: A group must e tive to rete/modify progrms. Progrm ts Selet to review/modify prmeters. Progrm Types drop-down list Selet to hoose progrm type from the predefined list. d Progrm drop-down list nd sroll uttons Selet to hoose progrm from the list of ville progrms. e Amplitude input ox Touh to selet trget vlue or to hnge the mplitude resolution. Note: If reting new progrm, eletrode omintion, pulse width, nd rte must e progrmmed prior to seleting the mplitude trget vlue. f Stop Amplitude Rmp utton Selet to stop the mplitude t new trget vlue while it is rmping. g Pulse Width input ox Touh to selet trget vlue from the list of vlues tht pper in the vlue window. Cution: To prevent possile unomfortle or unexpeted stimultion (jolting or shoking senstion), derese the mplitude to the pereption threshold (the mplitude t whih the ptient first pereives presthesi) efore hnging the pulse width. After hnging the pulse width, slowly inrese the mplitude. h Rte input ox Touh to selet trget vlue from the list of vlues tht pper in the vlue window. i Optimizer Selet to disply the Optimizer sreen (see pges 86-87). i d e f g h Progrm MyStim 84 85

44 Optimizer Use to quikly refine existing progrms using vritions of the initil progrm eletrode settings. Optimiztion sroll uttons nd drop-down list Selet to hoose n option (Optimiztion #1 Optimiztion #20). Amplitude input ox Touh to modify the mplitude setting. Stop Amplitude Rmp utton Selet this utton to stop the mplitude t new trget vlue while it is rmping. d Defult Amplitude Slide to redue the mplitude to non-zero vlue when evluting new optimiztion step. Note: The new mplitude vlue will e perentge of the Initil Progrm vlue. Defult Amp % is stored in the devie for future optimiztions. e Sve Selet to sve progrm to the Working List. f Cnel Selet to return to the stimultion settings present when Optimizer ws seleted. g Progrm Selet to progrm pending updtes. h OK Selet to tivte the progrm. d e f g h Optimizer Optimizer 86 87

45 Using Optimizer Using Optimizer Optimizer n e used to quikly refine existing progrms using vritions of the initil progrm eletrode settings. To refine progrms using the Optimizer feture: Aess the Progrm MyStim menu nd selet Progrm MyStim. Selet nd progrm group. Selet numered progrm t in the tive group. d Selet the Optimizer utton. e The Optimizer sreen is displyed with the seleted progrm shown s Initil Progrm in the Optimiztion drop-down list. f Slide the Defult Amplitude r to desired setting. g If desired, selet the Amplitude input ox to modify the mplitude setting. h Selet n option (Optimiztion #1 Optimiztion #20) from the Optimiztion drop-down list. The Sroll Right/Sroll Left uttons provide n lterntive method to view nd selet n option. i To tivte the seleted optimiztion, press the Progrmming P key or selet the Progrm utton on the progrmmer sreen. d e h g Using Optimizer j Press the OK MyStim sreen. utton to return to the Progrm f i j 88 89

46 TrgetStim TrgetStim Use to trnsition eletrode ptterns, utilizing interleved pulses nd rmping mplitude to lote effetive therpy. Group Seletion drop-down list Selet to hoose new or progrmmed group. Progrm drop-down list nd sroll uttons Selet to hoose progrm. Eletrodes Selet the eletrode -, +, or lnk (OFF) options on the led to e progrmmed. d Amplitude Adjustment uttons Selet to set or modify the mplitude. e Mrk Selet to sve n effetive therpy setting. f Rell Selet to return to the lst therpy setting mrked. g TrgetStim uttons Selet to trnsition the eletrodes while sking the ptient to provide responses to the stimultion. Note: The trnsition progress r fills to indite sttus. When the eletrodes re fully trnsitioned, the r fills nd disppers. Depending on the led onfigurtion seletion nd the sttus of the eletrodes, the TrgetStim uttons re enled/ disled nd trnsitioning the eletrodes is possile up/down or ross the leds. h d e f g i TrgetStim h Cnel Selet to return to the stimultion settings present when TrgetStim ws seleted. i OK Selet to tivte the group

47 Using TrgetStim TrgetStim trnsitions eletrode ptterns y using interleved pulses nd rmping mplitude to lote effetive therpy. It n e used to quikly identify nd refine therpy settings during intr opertive test stimultion, or it n e used to refine existing therpy during progrmming follow-up sessions. To rete/modify progrms using the TrgetStim feture: Selet nd progrm group or go to next step if using TrgetStim with no groups urrently defined. Using TrgetStim Aess the Progrm MyStim menu nd selet TrgetStim. Selet group from the Group Seletion drop-down list. Note: Hold the progrmming hed stedy over the neurostimultor while performing the remining progrmming funtions. Selet progrm from the Progrm drop-down list. The Sroll Right/Sroll Left uttons provide n lterntive method to view nd selet progrm. Set or modify eletrode polrities s needed. Selet the eletrode -, +, or lnk (OFF) options on the led to e progrmmed. d Set or modify the mplitude s needed. e Use the TrgetStim uttons to trnsition the eletrodes while sking the ptient to provide responses to the stimultion. Note: The trnsition progress r fills to indite sttus. When the eletrodes re fully trnsitioned, the r fills nd disppers. Cution: To prevent or minimize possile unomfortle or unexpeted stimultion (jolting or shoking senstion), wit for the ptient s response to stimultion hnges while trnsitioning eletrodes. If the ptient experienes unomfortle stimultion, derese the mplitude, reverse the eletrode trnsition, or turn the neurostimultor off. f If desired, use the Mrk utton to sve n effetive therpy setting nd ontinue trnsitioning the eletrodes. g Selet the OK utton to tivte the group. d f e g Using TrgetStim 92 93

48 Limits/Settings Limits/Settings RestoreAdvned nd PrimeAdvned Use to progrm the rnges in whih ptient n djust progrmmed prmeters using the MyStim progrmmer. Refer to pge 50 for RestoreUltr Limits/Settings. Group Seletion drop-down list Selet to hoose ville group(s). Note: If the A-Z option is seleted, the setting will e progrmmed to pply to ll existing nd new groups. Limit Types Selet to hoose options for eh stimultion prmeter. Limit type Full Rnge Customize Off Definition The ptient is le to djust the vlue for the seleted stimultion prmeter within the entire rnge provided y the neurostimultor. Cliniin-set limits (ustom or trking) re progrmmed. The ptient is le to djust the vlue for the seleted stimultion prmeter within these limits. The ptient is not le to djust the vlue for the seleted stimultion prmeter. Limit Vlue oxes (for setting ptient ontrol limits) Aville only if liniin-set limits re progrmmed (ustomize rdio utton seleted). Selet to set mplitude, pulse width, nd rte upper nd lower limit vlues. d GroupAdjust Selet to enle the GroupAdjust feture. Note: This feture llows the ptient to inrese or derese ll progrm mplitudes in the tive group t the sme time using the MyStim progrmmer. Also ville with ENS model e TrgetMyStim Selet to ess the TrgetMyStim sreen nd enle/disle TrgetMyStim for individul groups. Amplitude Lower Limit must e set to 0.0 V for eh progrm. Note: This feture llows the ptient to move stimultion settings from eletrode to eletrode up nd down the led using the MyStim progrmmer (refer to pges nd ). f SoftStrt/Stop Selet to slowly inrese the mplitude when the neurostimultor is turned ON nd slowly derese the mplitude when hnging groups, yling, or during sheduled therpy group trnsitions/hnges. g SoftStrt/Stop input ox Selet to set SoftStrt/Stop vlue. h Cyling Selet to turn the neurostimultor ON nd OFF t liniin-determined intervls (i.e., 0.1 seonds to 30 minutes) d f h e g Limits/Settings

49 Using Limits/Settings Using Limits/Settings Ptient ontrol limits for mplitude, pulse width, nd rte re set y the liniin nd progrmmed to the neurostimultor. The ptient uses MyStim progrmmer to djust the prmeter vlues within the liniin-set limits. Note: Progrmmed settings for these fetures re the sme for ll progrms in group. These fetures n e progrmmed for eh individul group, or the fetures n e progrmmed to pply to ll existing nd new groups using the A-Z group seletion (for RestoreAdvned nd PrimeAdvned). See pge 50 for RestoreUltr Limits/Settings. If the Full Rnge option is seleted for eh of the prmeters, the ptient will e llowed ess to: n mplitude rnge of 0.0 V-10.5 V pulse width rnge of 60 μs-450 μs pulse rte rnge of 2 Hz-130 Hz (1 or 2 progrms), 2 Hz-85 Hz (3 progrms), or 2 Hz-65 Hz (4 progrms) 1 Using Limits/Settings To set A-Z limits for ll groups using the Full Rnge option: Selet Limits/Settings from the Progrm MyStim menu. If needed, selet A-Z from the Group Seletion drop-down list. Selet the Full Rnge rdio utton for the desired prmeter. d Selet the Progrm utton. e 4 To enle the GroupAdjust feture: Note: If pproprite for the ptient, the GroupAdjust feture n e enled to llow the ptient to inrese or derese ll progrm mplitudes in the tive group t the sme time. e Selet the GroupAdjust hekox to enle the feture nd then selet the Progrm utton d

50 TrgetMyStim The TrgetMyStim feture is only ville when using the models 97740, 37743, nd MyStim progrmmer with RestoreSensor, RestoreUltr, RestoreAdvned, or PrimeAdvned neurostimultor. TrgetMyStim is feture enled y the liniin on the N Vision progrmmer. This feture llows the ptient to refine therpy settings y trnsitioning eletrode ptterns. TrgetMyStim Enling TrgetMyStim: Selet Limits/Settings from the Progrm MyStim menu. Selet the TrgetMyStim utton. The TrgetMyStim sreen is displyed. d Selet the groups for whih you would like to enle the TrgetMyStim feture. e Selet the OK sreen. f Selet the Progrm sreen. utton to lose the TrgetMyStim utton on the Limits/Settings f Note: In order for the the TrgetMyStim feture to e enled, verify the eletrode pttern in the progrm is le to move up nd down the led, the mplitude limits re enled, nd the mplitude lower limit is set to 0.0 V. In ddition, mke sure group pulse width does not exeed 450 µs nd group rte does not exeed 260 Hz. d trgetmystim e 98 99

51 MyStim Progrmmer Ptient ontrol limits re set y the liniin. The ptient uses MyStim progrmmer to djust the prmeters within these limits. Ptient Control Options : Stimultion ON/OFF Ptient ontrols stimultion ON/ OFF. Stimultion ON/OFF nd Groups Ptient ontrols stimultion nd n selet group to e used (i.e., posturl or tivity hnges). Note: Group nmes seleted during progrmming will e ville s ions or text. If no nme is seleted letter (e.g., A, B, C) will e used s the group nme. Stimultion ON/OFF nd Prmeter Adjustment Ptient ontrols stimultion nd n selet prmeter settings within the group. Stimultion ON Stimultion ON/OFF nd Groups -or- 1 Stimultion OFF 1.8 Amplitude Chnges how strong the stimultion feels or the spred of the stimultion re. Stimultion ON/OFF nd Prmeter Adjustment MyStim Progrmmer d Pulse Width Chnges how strong the stimultion feels or the spred of the stimultion re. Rte Chnges how smooth the stimultion feels. Rte feels like tpping. Amplitude Group Adjust Simultneously hnges how strong the stimultion feels or the spred of the stimultion re for ll tive progrms. Stimultion ON/OFF, Groups, nd Prmeter Adjustment Ptient ontrols stimultion nd n selet group, s well s the prmeter settings (see desriptions ove) within eh group. e Dily ERI Messge (for PrimeAdvned nonrehrgele neurostimultor only) Ptient needs to ll liniin to shedule visit. To ler the sreen, ptient must press ny rrow on the nvigtion key. After lering the sreen, low ttery ion ppers on the Sttus row of the Therpy Sreen. d e -or- Stimultion ON/OFF, Groups, nd Prmeter Adjustment Dily ERI Messge For PrimeAdvned Nonrehrgele neurostimultor Only MyStim Progrmmer

52 Using TrgetMyStim Note: TrgetMyStim is ville only with MyStim progrmmer models 97740, 37743, nd Using TrgetMyStim Hold the MyStim progrmmer over the neurostimultor nd press the NEUROSTIMULATOR ON key. ON e Press the Inrese or Derese key to disply the initil TrgetMyStim Sreen. f To hnge tive eletrode positions s needed, press the Inrese or Derese key to move stimultion to the desired position. Using TrgetMyStim Verify the pproprite group is tive Group row. Group row on the Use the up s nd down t NAVIGATOR keys to selet the Prmeter row. Prmeter row d use the left nd right NAVIGATOR keys to selet the pproprite TrgetMyStim ion ( ). t s g One the desired level is displyed, hold the progrmmer over the neurostimultor nd press the Syn key to hnge to the seleted eletrode position nd to slowly inrese the mplitude. Note: A series of eeps will e herd while the mplitude is inresing. Pressing the Inrese or Derese key will stop the mplitude inrese efore it rehes the progrmmed vlue. h Press the left NAVIGATOR key to return to the Therpy Sreen. t Syn Key Using TrgetMyStim TrgetMyStim ion

53 Return to Cliniin Settings Return to Cliniin Settings (Aville with models 97740, 37743, nd only) Note: The Return to Cliniin settings feture is ville on the models 97740, 37743, nd MyStim progrmmer when used with RestoreSensor, RestoreUltr, RestoreAdvned, or PrimeAdvned neurostimultor or the model Externl Neurostimultion System (ENS). This feture llows ptients the ility to esily return to liniin-set prmeters while hnging progrmmed settings using their MyStim progrmmer. Return to Cliniin Settings (models 97740, 37743, nd only) Verify the pproprite group is tive on the Prmeter row. use the up s nd down t NAVIGATOR keys to selet the Sttus row. use the left nd right NAVIGATOR keys to selet Return to Cliniin Settings. d Synhronize the progrmmer nd neurostimultor. t s Return to Cliniin Settings

54 AutoFill Use to dd new groups reted from n existing group previously progrmmed. AutoFill provides n effiient method to ssemle multiple, new groups. AutoFill Group Seletion drop-down list Touh to selet the strting group to generte from (ll urrently progrmmed groups will e listed). Degree of Differene Selet the degree of differene for the eletrode ptterns. Numer of Groups to Generte Touh to selet the numer of groups you would like generted. AutoFill

55 Using AutoFill Used to dd new groups reted from n existing, previously progrmmed group, AutoFill provides n effiient method to ssemle multiple, new groups. To use the AutoFill feture: Aess the Progrm MyStim menu nd selet AutoFill. Selet the strting group to generte from using the drop-down list of ll urrently progrmmed groups. Selet the degree of differene for the eletrode ptterns (rte nd pulse width re unhnged). The following options re ville: Sme The generted group(s) will e identil to the strting group. Similr The generted group(s) will e reted using the Optimizer lgorithm to provide new eletrode ptterns. Using AutoFill Different The generted group(s) will e reted using the Optimizer lgorithm to provide new eletrode ptterns. Seleting this option generlly provides the highest degree of differene in eletrode ptterns. d Selet the numer of groups to generte using the drop-down list. e Press the Progrmming P key or selet the Progrm utton on the progrmmer sreen. f Review the informtionl messge tht ppers on the sreen. f d e Note: All new progrms re generted with n mplitude of 0.0 V. To set mplitudes for eh progrm, ess the Progrm MyStim sreen (see pges 82-85). Using AutoFill

56 Sheduled Therpy Note: Sheduled Therpy is not ville with RestoreSensor or RestoreSensor SureSn MRI. Use to progrm up to 8 events (n On/Off yle or hnging groups) within 24-hour period. Shedule Therpy Selet to enle or disle the Sheduled Therpy feture. To rete new sheduled therpy event, drg n empty event lok to the 24-hour event tle tht displys ll sheduled events. Event Detils sreen Appers when n empty event lok is drgged to the 24-hour event tle or when n existing event on the shedule is seleted. d Selet group from the drop-down list of ll of the urrently progrmmed groups. e Use the Inrese nd Derese uttons to set the sheduled therpy ON nd OFF times. f Selet the OK utton to ple the new event on the event tle. g Press the Progrmming P key or selet the Progrm utton on the progrmmer sreen. g d Sheduled Therpy e Sheduled Therpy f

57 Initil Settings Initil Settings Use to reset ll prmeters to vlues in effet t the strt of the session. Selet Initil Settings from the Progrm MyStim menu Selet OK to reset ll prmeters to vlues in effet t the strt of the session. Note: If you return to initil settings, you will lose ll hnges mde to group nd progrm prmeters, inluding Sheduled Therpy groups, during the session. (Note: Sheduled Therpy is not ville with RestoreSensor.) Initil Settings

58 End Session Print Reports Print Reports The informtion ontined in the Summry, Groups, nd Mesurements reports is sved s single session dt file in the Session Dt Mnger nd nmed with the ptient session nme. The following reports n e seleted for printing, depending on whether dt exist for the report. Summry report neurostimultor dt nd history. Groups report groups nd progrm informtion. Mesurements report ttery informtion nd results from the eletrode impedne test nd group impedne test. MyStim Diry report group use dt sine the lst session. Working List report informtion on ll progrms in the Working List. (Note: The Working List report is not ville with RestoreSensor.) Ptient report (to e given to the ptient) informtion on ptient settings, ville ptient ontrol limits, nd Sheduled Therpy. (Note: Sheduled Therpy is not ville with RestoreSensor.) MDT Dt report dt tht n e provided to Medtroni Tehnil Servies (this report is seprte file in the Session Dt Mnger). MRI-CS report MRI onditionlly sfe (MRI-CS) sn eligiility for the implnted neurostimultion system. To print report during the session: Ensure the printer is ON. Move the progrmmer to within 1 meter (3.3 feet) of the printer, with the printer nd progrmmer IR ports diretly fing eh other. Selet Print Reports from the End Session Menu. Selet the hekox next to the desired reports on the list. Selet the Print utton. Note: A printout of the finl settings should e pled in the ptient file. You n print sved session reports from the Session Dt Mnger or print urrent settings ny time during the progrmming session. Print Reports

59 Print Sreen You n print the urrent sreen displyed on the progrmmer nd send the imge to printer. To print the urrent sreen: Ensure the printer is ON. Move the progrmmer to within 1 meter (3.3 feet) of the printer, with the printer nd progrmmer IR ports diretly fing eh other. Selet Print Sreen from the End Session menu. Printer Sttus sreen displys. Print Sreen Print Sreen

60 End Session Neurostimultor settings progrmmed during the session re displyed on the End Session menu. Detiled settings progrmmed during the session re displyed on the Progrm MyStim menu. Group sroll uttons Selet to view summry settings progrmmed during the session. End Ptient Session utton Selet to end the urrent session. End Session End Session

61 Slider Br Slider Br Provides ess to progrmmer informtion, system settings, nd essories. Informtion Selet to disply the nmes, model numers, nd version numers for the progrmmer, pplition, nd ssoited softwre nd peripherl devies. Settings Selet to djust the disply ontrst, speker volume, nd key lik sound, nd to lirte the touhsreen. Loliztion Touh to selet the lnguge preferene, selet/set the dte formt, selet the deiml formt, nd selet/set the time formt. d Session Dt Mnger Selet to view, print, nd delete session reports. e Clultor Selet to ess the lultor. f Exit Applition Selet to return to the Applition Seletion sreen to selet new pplition. d e f Slider Br

62 Session Dt Mnger To print reports: Highlight the session dt file you would like to print nd selet the Print Short Report ion or the Print Long Report ion to move report into the print queue d. i The trnsmission is omplete when: Report is utomtilly removed from the print queue. On-Sreen Tskr Inditor i hnges from to. Session Dt Mnger Printing Tips (prior to queuing report): Move the progrmmer to within 1 meter (3.3 feet) of the printer. Ensure tht the infrred (IR) port on the progrmmer nd IR port on the printer re diretly fing eh other. Hold the progrmmer stedy until the report trnsmission hs ompleted. Reports Selet session dt files for printing, reviewing, or deleting. Print Short Report Selet to print short version of report (i.e., summry report only). Print Long Report Selet to print long version of report (i.e., summry, groups, nd mesurement reports). d Print Queue e Remove From Queue Selet to remove highlighted report from the print queue. f Selet/Deselet ALL Reports g View Report Selet to disply dditionl detils for your highlighted session on sreen. h Delete Session File Selet to permnently delete session from the print queue or reports list. i On-Sreen Tskr Inditor Chnges from to one report trnsmission is omplete. d g e f h Session Dt Mnger