Neuropace PDMS 4340 User Manual Download

Page: 1 / 120

DN 1017919 Rev 2

Rev Date: 2018-06

RNS

System Programming Manual

For the RNS

Tablet Model 5000 and the

Patient Data Management System (PDMS) Model 4340

Summary of Contents for PDMS 4340

Page 1: ...2018 NeuroPace Inc DN 1017919 Rev 2 Rev Date 2018 06 RNS System Programming Manual For the RNS Tablet Model 5000 and the Patient Data Management System PDMS Model 4340...

Page 2: ...nt System model 4340 Note The RNS Tablet model 5000 is compatible with the RNS Neurostimulator model RNS 300M and model RNS 320 Note The term programmer as used in this manual is a generic term that r...

Page 3: ...following two conditions 1 These devices may not cause harmful interference and 2 these devices must accept any interference received including interference that may cause undesired operation IMPORTA...

Page 4: ...ing Ethylene Oxide Temperature Limits Ethernet Connection Network Connection Proposition 65 a State of California voter initiative requires the following notice WARNING This product can expose you to...

Page 5: ...BLET 10 CONNECT AND LOGIN OVERVIEW 10 FUNCTIONALITY WITH AND WITHOUT A PDMS CONNECTION 11 CONNECT TO THE INTERNET FOR PDMS ACCESS 11 Mobile Broadband Works Automatically 11 Steps to Connect to a Wi Fi...

Page 6: ...ETECTORS 56 Detection Tools and Detectors 56 Power Change Detector 57 Rhythmic Activity Detector 59 Spike Activity Detector 60 Bandpass Detection Tool 61 Area Detection Tool 62 Advanced Controls 63 SH...

Page 7: ...No Communication Between the RNS Neurostimulator and the RNS Tablet 96 Tablet Does Not Turn On 97 Tablet Freezes or Does Not Turn Off 97 Tablet Shuts Down 97 Impedance Measurement Was Rejected Test R...

Page 8: ...viously retrieved neurostimulator activity information perform detection analysis and communicate with the NeuroPace Patient Data Management System PDMS via the Internet Note The term programmer as us...

Page 9: ...ta CONTACTING NEUROPACE All questions or concerns regarding the NeuroPace RNS System should be forwarded to NeuroPace Inc 455 N Bernardo Ave Mountain View CA 94043 Customer Support 866 726 3876 Toll F...

Page 10: ...and intracranial electrodes and neuroimaging and are experts in the treatment of epilepsy with antiepileptic medications epilepsy surgery and devices WARNING MANAGEMENT OF PATIENTS WITH THE RNS SYSTEM...

Page 11: ...ables other than those provided by NeuroPace could result in increased electromagnetic emissions or decreased electromagnetic immunity of the RNS System and result in improper operation WARNING PORTAB...

Page 12: ...n of telemetry can result in incomplete communication If EMI disrupts programming move the programmer away from the likely source of EMI Refer to Poor or No Communication Between the RNS Neurostimulat...

Page 13: ...e ports on the tablet may be sensitive to electrostatic discharge static electricity Handle the tablet ports carefully If exposed to electrostatic discharge the tablet may experience telemetry artifac...

Page 14: ...t Mobile broadband works automatically To connect to Wi Fi see Steps to Connect to a Wi Fi Network on page 12 Alternatively the tablet computer can also support use of a docking station that has an Et...

Page 15: ...ew detection set or adjust parameters of a detection set Yes CONNECT TO THE INTERNET FOR PDMS ACCESS When connected to the Internet and logged in to the Patient Data Management System PDMS the RNS Tab...

Page 16: ...keyboard but ignore these for now 2 Touch to select the small symbol that indicates network status If necessary touch outside the login fields to dismiss the keyboard and see the whole screen Figure 1...

Page 17: ...ivity you will not lose information you already programmed into the neurostimulator or saved to the PDMS but you will lose information not already programmed into the neurostimulator or saved to the P...

Page 18: ...tablet login screen appears first upon startup Select a user The screen prompts you for a username and password and displays the keyboard 2 Enter your username and password initially provided by Neuro...

Page 19: ...TIENT LIST and ECOG LIBRARY Figure 2 NeuroPace Log In screen for PDMS login To skip PDMS login select the BACK button in the upper right corner The Start screen opens 1 Select the fields to enter the...

Page 20: ...nd to the USB port on the tablet Figure 4 Tablet with connected wand 2 Place the wand within approximately 1 inch of the neurostimulator concave side of wand facing the neurostimulator Then select INT...

Page 21: ...Neurostimulator activity events are also known as diagnostics which include for example detection and stimulation events and magnet swipes Once the memory for ECoGs or diagnostics is full the neurost...

Page 22: ...en Note When logged in to the PDMS changes you make with the tablet are immediately saved to the PDMS If you lose connectivity you will not lose information you already programmed into the neurostimul...

Page 23: ...COMMUNICATION LOG TOOLBOX button to access UTILITIES dialog to IMPORT DEVICE and EXPORT DEVICE SETTINGS These features are designed to support neurostimulator replacement For instructions see Export a...

Page 24: ...open the NEUROSTIM INFO screen Figure 8 Neurostim Info screen The NEUROSTIM INFO screen provides information about the neurostimulator including At upper left whether DETECTION and STIMULATION are ENA...

Page 25: ...give context to the measured voltage See Significance of Battery Voltage on page 23 At lower right measured impedance for electrodes on the PORT 1 and PORT 2 leads Buttons to MEASURE impedance manual...

Page 26: ...ng measurement Note The system cannot measure impedance during a detected episode or during therapy delivery To measure impedance either wait for the episode or therapy to complete or disable detectio...

Page 27: ...CTIVITY screen Figure 11 Activity screen Note You must be logged in to the PDMS to access the ACTIVITY screen If you are not the NEUROPACE LOG IN screen opens when you select ACTIVITY prompting you to...

Page 28: ...ET SWIPE OFFICE INTERROGATION or IMPLANTS Select NEUROSTIM EVENTS on the left or right sides of the histogram to select items for layering on the graph you can select multiple items concurrently up to...

Page 29: ...y are present Figure 13 Activity screen view detection and stimulation settings used between programming sessions At the left end of each row is a blue tile showing the date range when those NEUROSTIM...

Page 30: ...RE 14 This helps to relate the programming changes to the device activity Figure 14 Activity histogram excerpt showing programming epoch 1 bracketed Next to the blue tiles the second column in Figure...

Page 31: ...ual At the right end of each row in Figure 13 is the ADV Advanced column Touch CLICK below ADV to view any advanced settings used in the screen that opens Figure 16 Touch X at upper right to close Fig...

Page 32: ...s Figure 17 Event List selected lists all events in a Neurostim Settings period with links to reports Types of Reports There are six types of patient reports Interrogation Initial or Subsequent within...

Page 33: ...of recent programming epochs summarizes the settings and activity of each epoch and highlights the changes in settings and activity from one epoch to the next ECOG LIBRARY SCREEN It is recommended to...

Page 34: ...Swipe left or right to view all ECoGs You can filter which ECoGs are displayed using TRIGGERS and CATEGORIES at upper left Figure 19 Use the FROM and TO fields at upper right to view ECoGs by date ran...

Page 35: ...20 Viewing a User saved ECoG Captured ECoGs reside in the RNS Neurostimulator memory until they are transferred to the programmer at the next interrogation with the wand and are then cleared from memo...

Page 36: ...re live ECoGs can be viewed See Create the Recording Montage on page 32 Note The maximum length for a live ECoG is four minutes If the live ECoG is allowed to scroll for more than four minutes only th...

Page 37: ...eurostimulator The figure below identifies neurostimulator PORT 1 and PORT 2 with their leads extending out of the ports Figure 22 RNS Neurostimulator port 1 and 2 locations Port 1 is closer to the ce...

Page 38: ...screen select NEUROSTIM INFO The NEUROSTIM INFO screen opens Note For all settings changed settings are indicated by blue buttons Gray buttons indicate settings have not changed 2 On the NEUROSTIM INF...

Page 39: ...or two channels The tablet requires you to use a positive input for electrodes assigned to two channels Note The tablet does not permit use of a negative input for electrodes assigned to two channels...

Page 40: ...ctrode 3 Electrode 4 Channel 3 Lead 2 Electrode 1 Electrode 2 Channel 4 Lead 2 Electrode 3 Electrode 4 GAIN set to HIGH for all channels default SCHEDULED IMPEDANCE settings Interval 7 days Current 3...

Page 41: ...stored in the neurostimulator If there is any new information be sure to interrogate the neurostimulator prior to programming 7 Select REVIEW PROGRAM at upper right Figure 25 8 On the REVIEW screen if...

Page 42: ...torage and the pre trigger and post trigger durations The oldest stored ECoGs are continually replaced by the newly stored ECoGs except as noted below The number of ECoGs stored for a particular ECoG...

Page 43: ...Programming Manual 2 On the NEUROSTIM SETTINGS screen select ECOG CAPTURE at upper right The ECOG CAPTURE screen opens Figure 26 ECoG Capture screen left side Swipe left to see right side Figure 27 R...

Page 44: ...Triggers There are three recommended ECoG triggers to be programmed at implant The first is a magnet swipe by the patient which could indicate that a clinical seizure has occurred The others are satu...

Page 45: ...G capture at the end of a detected episode Selecting this trigger may be helpful in evaluating activity after an episode NOISE Initiates ECoG capture when the ECoG signal exceeds 60 Hz Selecting this...

Page 46: ...Tablet Instructions 42 RNS System Programming Manual Figure 29 ECoG Capture showing recommended initial settings...

Page 47: ...he first several days after implantation of the neurostimulator and leads may not be representative of the patient s typical baseline activity ECoG capture settings should be reviewed to ensure that t...

Page 48: ...ult Detection Set upon First Use on page 45 you select one of the three default detection sets to gather an initial collection of ECoGs This is usually configured and programmed in the operating room...

Page 49: ...ponse has not been obtained and they wish to start over Phase 1 Select a Default Detection Set upon First Use Upon first use of the tablet for each patient the patient has no saved ECoGs from which to...

Page 50: ...nted this two channel option will not appear in the list The other default patterns detect on only one lead Power change 75 is a detection setting that captures any large changes in the signal that cl...

Page 51: ...eports that DETECTION is ENABLED keep the wand in place and select CONTINUE to proceed with programming or CANCEL to cancel programming and return to the previous screen When you select CONTINUE the P...

Page 52: ...ined on a specific channel can operate only in that selected ECoG channel Follow these steps to define a pattern detection set 1 Select NEUROSTIM SETTINGS from the HOME screen 2 On the NEUROSTIM SETTI...

Page 53: ...n set right away Select REVIEW PROGRAM at upper right and while holding the wand within approximately 1 inch of the neurostimulator follow the prompted steps to CONFIRM PROGRAMMING and CONTINUE sendin...

Page 54: ...ntain the type of pattern you would like to detect Each 3 second window is identified as one of the four possible patterns you can define A1 A2 B1 or B2 The 1 and 2 indicate the first and second ROI y...

Page 55: ...to bottom Use the CHANGE CHANNEL button to change the channel on which to detect the pattern Note If simulating performance of a 2 channel detection set be sure to select ECoGs that contain ECoG acti...

Page 56: ...r Phase 3 Customize Pattern Detection To customize pattern detection is to refine detection settings to promptly detect the specific patterns for this patient and not detect on baseline activity since...

Page 57: ...tection set shown by default in the NAME field at upper left The upper half of the screen provides tiles to select the current detection patterns and channels the tiles are named PATTERNS A1 B1 upper...

Page 58: ...ection with the changed parameter as applied to this ECoG and to the patient s other stored ECoGs shown in smaller size below It is recommended to review simulated detection activity on an ensemble of...

Page 59: ...CHANGE the sliders adjust SENSITIVITY and DETECT seconds Note The parameter values are shown to the right of each slider For all four parameters lower values result in greater sensitivity Make adjustm...

Page 60: ...type of activity you wish to detect This detection set is a suggested starting point to assist you as you exercise clinical judgment to define detection settings It suggests a starting point only It d...

Page 61: ...ity AREA Area configured manually only not used as a suggested detector Power Change Detector To understand how the power change detector works refer to Figure 39 Imagine the ECoG as a string that can...

Page 62: ...typically 1 to 4 seconds red line in graph to the normalized ECoG length in a long term trend window typically 1 to 2 minutes blue line in graph Figure 39 Power Change detector example Detection occu...

Page 63: ...e and duration requirements Four configurable parameters define the Rhythmic Activity detector operation the MINIMUM FREQUENCY and MAXIMUM FREQUENCY that define the bandpass the AMPLITUDE and the DURA...

Page 64: ...detector operation the MINIMUM FREQUENCY and MAXIMUM FREQUENCY the AMPLITUDE and the DURATION The MINIMUM FREQUENCY defines the slowest spiking rate that can be detected The MAXIMUM FREQUENCY defines...

Page 65: ...ecific and early detection of rhythmic and spiking activity It acts like a frequency filter and can therefore be used to detect activity within specific frequency bands for example theta alpha beta an...

Page 66: ...tool measures the area between the ECoG and the time axis see Figure 43 Figure 43 Area detection tool example The Area detector operates by comparing the normalized ECoG area area per second in a shor...

Page 67: ...log for the pattern you are currently defining which gives access to additional settings for the detection tools BANDPASS POWER CHANGE and AREA AREA can be selected only in this dialog Select the down...

Page 68: ...to the PDMS during programming you can program the neurostimulator with any detection set saved under the current username or saved to the programmer you are using However if you are not connected to...

Page 69: ...g the foregoing method merely makes it available to the targeted user or programmer when connected to the PDMS Shared detection sets are not automatically downloaded and saved locally to the programme...

Page 70: ...these steps Figure 47 Start screen 1 Select the PATIENT LIST tile on the tablet Start screen The patient list opens 2 Select a patient from the patient list The PATIENT HOME screen opens Note this is...

Page 71: ...ion set you want to download to the tablet 5 Select the SHARE button The SHARE DETECTION SET dialog opens but in this case it includes a checkbox named Download to this Programmer now along with the o...

Page 72: ...ption selected 7 Select the SHARE button A download progress dialog appears briefly and when download is complete a PDMS Transfer message reports The detection set download has completed successfully...

Page 73: ...ou can select up to two bursts to be delivered in response to any event detector as depicted in Figure 54 All subsequent therapies deliver a maximum of 2 bursts and are independent of the event detect...

Page 74: ...ou select therapy specific to a detection pattern at least one detector must be defined for each pattern To set up a therapy sequence determine the number of therapies desired for delivery in response...

Page 75: ...u cannot skip a therapy Recall that detection must be enabled before any therapy can be configured 3 For each desired stimulation therapy and burst starting with STIM 1 BURST 1 select the electrodes o...

Page 76: ...creen results from the combination of CURRENT and PW PER PHASE The tablet limits the available choices for CURRENT and PW PER PHASE to those which yield a CALCULATED CHARGE DENSITY less than 25 C sq c...

Page 77: ...ptions on the right side of the Stimulation settings screen a BEHAVIOR FOR THERAPY 1 The default is EITHER DETECTION PATTERN RESULTS IN SAME THERAPY Select the field to select the alternate DETECTION...

Page 78: ...ogramming Manual Optional Advanced Settings If desired select ADVANCED at far right to open the ADVANCED SETTINGS screen for the selected therapy STIM row By default all advanced settings are disabled...

Page 79: ...ADAPT CHANNEL Select one of four channels over which to enable adaptive therapy By default this is UNUSED which means adaptive therapy is disabled ADAPT MIN AMPLITUDE Select a percentage of the detect...

Page 80: ...lower portion of Advanced Settings dialog SYNCH CHANNEL Select one of four channels over which to deliver synchronized therapy SYNCH MIN AMPLITUDE Select a percentage of the detected signal amplitude...

Page 81: ...during therapy delivery To test stimulation either wait for the episode or therapy to complete or disable detection and therapy 1 Select TEST on the far left of the row to open the TEST STIMULATION sc...

Page 82: ...should be adjusted to prevent such occurrence Enable Therapy Review Program The new settings are not sent to the neurostimulator until you complete these steps 1 Select REVIEW PROGRAM at upper right...

Page 83: ...lt values FREQUENCY 200 Hz PW PER PHASE 160 s BURST DURATION 100 ms Apply the same settings to all five stimulation therapies select the YES button next to ALL SETTINGS SAME AS STIM 1 near top center...

Page 84: ...red ECoGs Adjust stimulation settings if the patient reports an acute worsening or increase in clinical seizures that is not typical Consider making minor adjustments if the patient reports only a mil...

Page 85: ...ettings from an RNS 300M to an RNS 300M or to an RNS 320 and you can transfer settings between RNS 320 devices Note SCHEDULED IMPEDANCE is a new feature in the RNS 320 It allows you to select which el...

Page 86: ...fies you if the tablet has no settings that came from a compatible neurostimulator for example if you exported from an RNS 320 for use on an RNS 300M Figure 67 Import Device Settings dialog Note Devic...

Page 87: ...dialog shows programming progress until complete The imported settings are deleted from the tablet when programming is complete If you do not complete this step the settings will remain available on t...

Page 88: ...nnected to the PDMS through the Internet Figure 69 Tablet Start screen Whether you select PATIENT LIST on the tablet Start screen or log in to the PDMS on a personal computer the information is displa...

Page 89: ...web browser and select the PDMS link on www neuropace com 2 Enter your USERNAME and PASSWORD 3 Click LOG IN Figure 70 PDMS Login on a personal computer Note If you have forgotten your password select...

Page 90: ...on the tablet select PATIENT LIST from the Start screen The PATIENT LIST screen opens When you log in to the PDMS via a web browser it opens directly on the PATIENT LIST screen Figure 71 Patient List...

Page 91: ...patient PATIENT NEUROSTIM INFO NEUROSTIM SETTINGS ACTIVITY ECOG LIBRARY LIVE ECOGS You can switch between patient views or return to the PATIENT HOME screen by touching the screen title at upper left...

Page 92: ...COG CAPTURE screens These have the same names as found through the NEUROSTIM SETTINGS screen after you interrogate the neurostimulator Here are the similarities and differences PATTERN DETECTION scree...

Page 93: ...he programmer is offline as is required for example if an operating room lacks network connectivity Note that these instructions apply whether the target programmer is a model PGM 300 laptop or model...

Page 94: ...eview current settings only ACTIVITY The ACTIVITY screen is a reporting screen only It looks and behaves as shown and explained under Activity Screen starting on page 23 ECOG LIBRARY The ECOG LIBRARY...

Page 95: ...n page 44 Responsive therapy settings see Configure Responsive Therapy on page 70 Note You must be connected to the PDMS via the Internet to review stored ECoGs neurostimulator activity and all other...

Page 96: ...tuck or is not responding select the REFRESH button at upper right Note If you attempt to connect to a Wi Fi network that requires you to go to an Internet website to log in as in some hotels and coff...

Page 97: ...Ohms The high impedance may be due to air Irrigate the area around the cortical strip lead and examine the geometry Repeat impedance measurements If the impedance remains abnormal the cortical strip...

Page 98: ...the relevant section of the system manual Poor Connection If the lead is not completely installed in the connector cover it is recommended to surgically revise the connection between the connector co...

Page 99: ...to determine the cause An example interrogation report is shown below in Figure 77 Figure 77 Accessing an interrogation report that shows insufficient charge Noise Artifacts Poor Signal Displayed or N...

Page 100: ...he problem persists replace the neurostimulator Refer to the relevant section of the system manual Troubleshooting During a Routine Follow up 1 Reposition the wand over the RNS Neurostimulator and int...

Page 101: ...till does not start contact NeuroPace for further assistance see Contacting NeuroPace on page 4 Tablet Shuts Down 1 Plug the tablet into a grounded power outlet 2 Restart the tablet Press and hold the...

Page 102: ...ac 4G fallback to 3G OPERATING DISTANCE Varies Wi Fi and cellular range similar to other smartphones and tablets FREQUENCY BAND OF OPERATION Wi Fi 2 4 GHz or 5 GHz Cellular 700 1900 1700 2100 MHz INTE...

Page 103: ...connectivity to leads and automatically recover from certain conditions Electromagnetic disturbances may be detected by the neurostimulator as noise or saturation and therefore suppress the ability of...

Page 104: ...oothbrushes electric shavers and hair trimmers Microwave ovens Appliances such as washing machines dryers electric stoves toasters blenders electric can openers and food processors Electric blankets a...

Page 105: ...stem should assure they are used in such an environment Note Unless otherwise indicated in the table footnotes emissions testing information in the tables below apply to all of the devices addressed i...

Page 106: ...61000 4 11 0 UT 0 5 cycle 0 UT 1 cycle d 40 UT 5 cycle d 70 UT 25 cycles 0 UT 5 Sec If the user of the programmer and wand requires continued operation during power mains interruptions it is recommen...

Page 107: ...in the ISM bands b Separation distance relevant to Programmer model PGM 300 and Remote Monitor model DTR 300 At 80 MHz and 800 MHz the higher frequency range applies c These guidelines may not apply...

Page 108: ...100 11 67 11 67 23 33 a All separation distances relevant to Programmer model PGM 300 and Remote Monitor model DTR 300 At 80 MHz and 800 MHz the higher frequency range applies b These guidelines may...

Page 109: ...le cover is intended to secure the leads to the burr hole cap Burst An individually programmed group of one to many pulse s of current delivered by the neurostimulator Burst Duration The amount of tim...

Page 110: ...rain and can detect the electrical activity of the brain and deliver stimulation Detection Settings Settings that combine patterns and detection tool settings in order to detect activity Detection Too...

Page 111: ...to trigger ECoG storage Max Therapy Frequency The max therapy frequency is an advanced setting available for each responsive therapy burst For an adaptive therapy burst Adaptation ON the max therapy f...

Page 112: ...d diagnostic information from the neurostimulator for viewing Programming Using the programmer to program settings into the neurostimulator Pulse A biphasic waveform of electrical stimulation delivere...

Page 113: ...channel for ECoG signal peaks to calculate synchronous delivery timing One channel will be used for all bursts selected to have synchronous pulse delivery Synchronization Delivering the first pulse i...

Page 114: ...attery Measurement 23 Battery Voltage 22 burst 71 BURST DURATION 72 bursts or burst 69 CALCULATED CHARGE DENSITY 72 Capture Duration 40 Capture ECoGs 38 Capture Triggers 40 CAPTURE WINDOW field 31 40...

Page 115: ...n 29 ECoG Records 29 ECoG Artifacts 95 ECoG Live 95 ECoGs Live 31 35 Electrode 1 is most distal 33 Electrode Impedance 22 electrodes numbered 1 through 4 33 Electromagnetic Emissions and Immunity 99 E...

Page 116: ...ettings 44 Montage Create 32 MORE CONTROLS button 51 55 NAME field 48 53 Network Connectivity Problems 92 NETWORKS panel 12 NeuroPace components warning 7 NEUROSTIM EVENTS 24 Neurostim Info Screen 20...

Page 117: ...mer login 14 programming epoch 23 PW PER PHASE 72 Recommendation for Review of Initial ECoG Capture Settings 43 Recommended Initial ECoG Capture Settings 41 Recommended Initial Montage Settings 35 Rec...

Page 118: ...in 14 Tablet Shuts Down 97 Tablet Specifications 98 Tablet Wireless Specifications 98 TECHNICAL PARAMETERS 63 Test Stimulation Before Enabling 77 TEST STIMULATION screen 77 Therapy Configuration 70 TH...

Page 119: ......

Page 120: ...RNS System Programming Manual NeuroPace Inc 455 N Bernardo Ave Mountain View CA 94043 Customer Support 1 866 726 3876 Toll Free in the US Fax 650 237 2855 Website www NeuroPace com...

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