Related Manuals for Neuropace RNS 5000
Summary of Contents for Neuropace RNS 5000
- Page 1 ® System Programming Manual ® For the RNS Tablet Model 5000 and the Patient Data Management System (PDMS) Model 4340 © 2018 NeuroPace, Inc. DN 1017919 Rev 2 Rev Date: 2018-06...
-
Page 2: About This Manual
Note: The term “programmer” as used in this manual is a generic term that refers to either the ® ® Tablet or the NeuroPace Programmer (laptop computer). Note: Images in this manual are representative and may vary in detail from what a particular user experiences. -
Page 3: Fcc Information
(1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to these components not expressly approved by NeuroPace, Inc. could void the FCC Certification, and negate your authority to operate them. -
Page 4: Symbols
YMBOLS Explanation of symbols on product or package labeling Caution Do Not Resterilize MR Unsafe Prescription Only Non-Pyrogenic Single Use Sterilized Using 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 chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. -
Page 5: Table Of Contents
ABLE OF ONTENTS ...................... BOUT THIS ANUAL FCC I ......................NFORMATION ........................YMBOLS INTRODUCTION ......................4 ..................... 4 EVICE ESCRIPTION ® ....................... 4 ABLET ® ............4 EURO ATIENT ANAGEMENT YSTEM ..................4 RODUCTS AND CCESSORIES ..................... 5 ONTACTING EURO .................. - Page 6 Advanced Views ..........................29 ....................29 IBRARY CREEN ....................31 CREEN ................32 REATE THE ECORDING ONTAGE Identifying Ports, Leads and Electrodes on the Neurostimulator ............33 Creating the Montage ......................... 34 Recommended Initial Montage Settings..................... 35 Program the Neurostimulator with the New Settings ................. 37 ....................
- Page 7 ........................90 CTIVITY ......................90 IBRARY ....................... 90 PATIENT FOLLOW-UP ACTIVITIES ................91 TROUBLESHOOTING ....................92 Network Connectivity Problems ......................92 Abnormal Lead Impedance (greater than 3500 Ohms or less than 250 Ohms) ........ 92 Insufficient Charge..........................95 Noise, Artifacts, Poor Signal Displayed, or No Signal Displayed in Live ECoG......... 95 ®...
-
Page 8: Introduction
® ABLET ® The RNS Tablet includes a tablet computer that runs proprietary NeuroPace software, and uses custom ® telemetry components to communicate with the RNS Neurostimulator. Clinicians can use the tablet to program how the neurostimulator operates. Settings include, but are not limited to, the implanted system... -
Page 9: Contacting Neuro Pace
All NeuroPace manuals are available at www.NeuroPace.com or by contacting NeuroPace, Inc. (see Contacting NeuroPace on page 4). ® Refer to the clinical summary booklet for information on the clinical study results of the RNS System and adverse event data. -
Page 10: Warnings And Cautions - Programmer
Comprehensive Epilepsy Center for regular follow-up (e.g. because of distance from the Center or limited access to transportation). These neurologists will be qualified by NeuroPace to provide ®... - Page 11 WARNING: EURO OMPONENTS Use of accessories, transducers, and cables 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.
-
Page 12: Sterilization And Storage
® Program all detection and therapy functions to DISABLED prior to explanting and shipping the RNS Neurostimulator. Return the explanted neurostimulator and leads to NeuroPace. NeuroPace will provide shipping containers if requested. DO NOT incinerate the neurostimulator; explosion can occur if the neurostimulator is exposed to incineration or cremation temperatures. -
Page 13: Electrostatic Discharge (Esd) / Static Electricity
Introduction Electrostatic Discharge (ESD) / Static Electricity The 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 artifacts or errors, or may freeze. In the event of a tablet freeze, refer to Tablet Freezes on page 97. ®... -
Page 14: Rns ® Tablet Instructions
(wired connection). Contact NeuroPace customer service if you prefer this alternative. 2. Login to the tablet. NeuroPace provides the initial username and password for this login. 3. Login to the Patient Data Management System (PDMS), which requires the Internet connection established in the first step. -
Page 15: Functionality With And Without Apdms Connection
The tablet ships with Wi-Fi and mobile broadband enabled. Mobile Broadband Works Automatically Mobile broadband is pre-configured by NeuroPace to be on and working, so no further effort is necessary and the tablet will connect to mobile broadband automatically if a signal is available. -
Page 16: Steps To Connect To A Wi-Fi Network
Tablet Instructions Steps to Connect to a Wi-Fi Network ® Follow these steps to connect via Wi-Fi to the Internet on the RNS Tablet. 1. The tablet login screen appears first upon startup. Select a user. The screen prompts you for a username and password and displays the keyboard, but ignore these for now. -
Page 17: If You Lose Network Connectivity
E on the P dialog. Then follow the Steps to Connect to a Wi-Fi ROGRAMMER Network on page 12. If you still cannot connect, contact NeuroPace for further assistance (see Contacting NeuroPace on page 4). ® System Programming Manual... -
Page 18: Log I N To The Rns ® Tablet
1. The 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 NeuroPace) and select Enter. Login completes if the password is correct and then the N... -
Page 19: Log I N To The Pdms
If Internet not available, select Back to go to Home screen without logging into the PDMS. Figure 2 NeuroPace Log In screen—for PDMS login To skip PDMS login, select the B button in the upper right corner. The Start screen opens. -
Page 20: Interrogate The Rns ® Neurostimulator
Tablet Instructions ® NTERROGATE THE EUROSTIMULATOR ® To interrogate the RNS Neurostimulator means to identify it, perform routine tests and measurements, and retrieve currently programmed settings and stored data from it. Follow these steps to interrogate: 1. Connect the wand to the USB port on the tablet. Figure 4 Tablet with connected wand 2. -
Page 21: Data Etention And
Tablet Instructions The I dialog shows progress and the H screen appears when NTERROGATING NEUROSTIMULATOR complete. It takes from 10 seconds up to 5 minutes, depending on the amount of data to be retrieved. Interrogation does not significantly drain the neurostimulator battery The dialog has bars that show the L and Q of the S... -
Page 22: Home Screen
Tablet Instructions Note: If automatic upload to the PDMS does not complete successfully, data is not lost. Data is cleared from the programmer or remote monitor only after a successful upload. CREEN The Tablet Home screen is the launch point for all programming activities. Figure 6 Tablet Home screen Note: When logged in to the PDMS, changes you make with the tablet are immediately saved to the PDMS. - Page 23 Tablet Instructions • button to access the PDMS C IRELESS IGNAL OMMUNICATION • button to access U dialog to I and E OOLBOX TILITIES MPORT EVICE XPORT EVICE ETTINGS These features are designed to support neurostimulator replacement. For instructions, see Export and Import Device Settings for Neurostimulator Replacement on page 81.
-
Page 24: Neurostim Info Screen
Tablet Instructions EUROSTIM CREEN Select N from the H screen to open the N screen. EUROSTIM EUROSTIM Figure 8 Neurostim Info screen The N screen provides information about the neurostimulator, including: EUROSTIM • At upper left, whether D and S are E or D and Alerts, if any... - Page 25 Tablet Instructions • At middle right, M with M button. The early, mid and late life EASURED ATTERY OLTAGE EASURE voltage ranges are displayed to give context to the measured voltage. See Significance of Battery Voltage on page 23. • At lower right, measured impedance for electrodes on the P #1 and P #2 leads...
-
Page 26: Electrode Impedance And Battery Voltage
Tablet Instructions Electrode Impedance and Battery Voltage Interrogation includes measuring electrode impedance and battery voltage, and these measurements are reported on the N screen. The N tile and screen show an alert if the EUROSTIM EUROSTIM impedance measurement detects insufficient charge for one or more electrodes. Figure 9 Insufficient charge alert shown on the N tile and screen EUROSTIM... -
Page 27: Activity Screen
Tablet Instructions For troubleshooting information, refer to Abnormal Lead Impedance (greater than 3500 Ohms or less than 250 Ohms) on page 92; and Insufficient Charge on page 95. Significance of Battery Voltage ® Normal RNS Neurostimulator battery voltage measurements are between 2.38 and 3.20 Volts. When the battery voltage measurement drops to 2.37 Volts or less, neurostimulator replacement is recommended, and the tablet notifies you on screen by showing the elective replacement indicator (ERI). -
Page 28: Activity Histogram Viewing Options
Tablet Instructions Activity Histogram Viewing Options The interface provides many options for viewing activity. • • Select E at upper left or right to see Select F at upper right to see events POCHS LAGS events from A flagged with M LL EPOCHS ETECTION ONLY AGNET... -
Page 29: View Neurostim Settings
Tablet Instructions View Neurostim Settings The lower part of the A screen details the history of detection and stimulation settings used— CTIVITY collectively called N —between each iteration of programming (each programming EUROSTIM SETTINGS epoch), which are in rows from most recent on top to oldest on the bottom. Drag up the gray separator bar to view more of these settings, which will cover the upper histogram portion. - Page 30 Tablet Instructions Also the corresponding time period is bracketed in the histogram graph, and the row number and start date appear over the bracketed time period, if there is enough room on screen (see F 14). This IGURE helps to relate the programming changes to the device activity. Row number Programming Start Date Brackets of...
- Page 31 Tablet Instructions At the right end of each row in Figure 13 is the A (Advanced) column. Touch C below A LICK view any advanced settings used in the screen that opens (Figure 16). Touch (X) at upper right to close.
-
Page 32: View Event List
Tablet Instructions View Event List Select E next to N above the left end of the row (Figure 17) to see a VENT EUROSTIM ETTINGS complete list of events for all rows. From there, select links under R for detailed reports EPORT YPES on each event. -
Page 33: Advanced Views
Tablet Instructions • Therapy Testing (shows therapy testing values) • ECoG • ECoG trigger time/date • ECoG record • ECoG trigger reason • ECoG markers (detections, stimulations, etc.) Advanced Views and P are the advanced views. D ETECTION VERAGED VENTS ROGRAMMING POCHS ETECTION... - Page 34 Tablet Instructions Figure 18 ECoG Library screen Each ECoG is identified by date and time captured and by capture trigger. Newest ECoGs are on the left, older ones toward the right. Swipe left or right to view all ECoGs. You can filter which ECoGs are displayed using T and C at upper left (Figure 19).
-
Page 35: Live Ec O G S Screen
Tablet Instructions Select a thumbnail to open it in a larger size, as shown below. ECoGs highlight detection and stimulation events. Detected activity appears in blue. Undetected activity appears in black. Colored flags mark specific points of detection or stimulation. You can Z in on the ECoG and increase the G . -
Page 36: Create The Recording Montage
Tablet Instructions After interrogation, keep the wand in place and select L from the H screen to open the screen. An ECoG is live when you open it. Buttons provide various options for viewing the live ECoG. Select S to save the ECoG in the patient’s ECoG library. It remains on screen after TORE you stop and store it until you start another live ECoG. -
Page 37: Identifying Ports, Leads And Electrodes On The Neurostimulator
Tablet Instructions corresponding detection settings. When the montage is altered, the detection settings created with the previous montage are discarded and the detection settings must be reprogrammed. Identifying Ports, Leads and Electrodes on the Neurostimulator The figure below identifies neurostimulator P #1 and P #2 with their leads extending out of the ports. -
Page 38: Creating The Montage
Tablet Instructions Creating the Montage 1. From the H screen, select N . The N screen opens. EUROSTIM EUROSTIM Note: For all settings, changed settings are indicated by blue buttons. Gray buttons indicate settings have not changed. 2. On the N screen, select C at lower right. -
Page 39: Recommended Initial Montage Settings
Tablet Instructions Select type of lead for Port #1 and Port #2 Lead label is editable Electrodes 1 - 4 for lead on Port #2 Measured Impedances Channel Rows Figure 24 Recording Montage screen 3. At Neurostimulator Implant and When Changing Leads – Select Lead Type: Upon first use of leads, you must select the lead type for P #1 and/or P #2. - Page 40 Tablet Instructions • Channel 2 = Lead 1: Electrode 3 [+], Electrode 4 [–] • Channel 3 = Lead 2: Electrode 1 [+], Electrode 2 [–] • Channel 4 = Lead 2: Electrode 3 [+], Electrode 4 [–] • set to H for all channels (default) •...
-
Page 41: Program The Neurostimulator With The New Settings
Tablet Instructions Program the Neurostimulator with the New Settings The new settings are not sent to the neurostimulator until you complete this step. Note: ECoG capture triggers are inactive during programming. Programming clears activity information and ECoGs stored in the neurostimulator. If there is any new information, be sure to interrogate the neurostimulator prior to programming. -
Page 42: Set Up Ecg O G Capture
Tablet Instructions ET UP APTURE ® Electrocorticograms (ECoGs) can be stored by the RNS Neurostimulator when an ECoG capture trigger occurs. The maximum number of ECoGs that can be stored is affected by the number of channel(s) selected ON for storage, and the pre-trigger and post-trigger durations. The oldest stored ECoGs are continually replaced by the newly stored ECoGs, except as noted below. - Page 43 Tablet Instructions 2. On the N screen, select ECOG C at upper right. The ECOG EUROSTIM ETTINGS APTURE screen opens. APTURE Figure 26 ECoG Capture screen, left side. Swipe left to see right side. Figure 27 Right side of ECoG Capture screen ®...
- Page 44 Tablet Instructions 3. Turn On Desired Channels: In the C area at lower right, select the ONFIGURE HANNELS switch next to the desired C ) (CH 1 through CH 4) to turn each channel on HANNEL or off as desired. Only the channels selected O will be recorded and stored.
-
Page 45: Recommended Initial Ecog Capture Settings
Tablet Instructions • : Initiates ECoG capture when the ECoG amplitude exceeds the threshold ATURATION associated with the value you select in the S field to the right. The ATURATION ENSITIVITY sensitivity options are High, Medium, Low and Off. Selecting this trigger may be helpful ®... - Page 46 Tablet Instructions Figure 29 ECoG Capture showing recommended initial settings ® System Programming Manual...
-
Page 47: Program The Neurostimulator With The New Settings
Tablet Instructions Program the Neurostimulator with the New Settings The new settings are not sent to the neurostimulator until you complete this step. Note: ECoG capture triggers are inactive during programming. Programming clears activity information and ECoGs stored in the neurostimulator. If there is any new information, be sure to interrogate the neurostimulator prior to programming. -
Page 48: Configure Pattern Detection : Define And Modify Detection Settings
Tablet Instructions • : Select a briefer C value to yield more stored ECoGs, or a URATION APTURE INDOW lengthier value to yield fewer stored ECoGs. If you make changes, be sure to follow the steps above to review and program the new settings into the neurostimulator. -
Page 49: Phase 1: Select A Default Detection Set Upon First Use
Tablet Instructions In future visits, after collecting additional ECoGs, you then, in Phase 3, iterate to improve detection (and, once responsive therapy has been enabled, to improve clinical response) by making small, incremental changes to detection parameters with the sliders or M ONTROLS Note: Typically, physicians repeat earlier phases (Phase 1 or Phase 2) only if they observe a new type of ECoG activity of interest that requires an additional detector;... - Page 50 Tablet Instructions 2. On the N screen, select P at upper center. A list of EUROSTIM ETTINGS ATTERN ETECTION three C appears. OMPATIBLE ETECTION 3. Select one of the three default detection settings. In the usual case, a patient has two active leads to be configured, and therefore the recommended default pattern is P OWER CHANGE 1 &...
- Page 51 Tablet Instructions When you confirm programming, a T dialog reports that “Detection is ELEMETRY NFORMATION Enabled and Responsive Therapy is disabled,” and prompts you to select C or C ONTINUE ANCEL Figure 30 Telemetry Information dialog to confirm programming again 6.
-
Page 52: Phase 2: Define A Pattern Detection Set
Tablet Instructions Phase 2: Define a Pattern Detection Set Note: You must be connected to the PDMS (via the Internet) to define a pattern detection set. If not, you can program only a default detection set or a detection set previously defined and downloaded to the tablet. - Page 53 Tablet Instructions the ECoGs shown using the T and C menus at left center, and/or by date RIGGERS ATEGORIES range using the F and T fields at middle right. • The S button at upper right (next to A ) is switched O (blue) by default, IMULATE DVANCED...
- Page 54 Tablet Instructions Using the Define Patterns Dialog Note: A pattern defines the type of ECoG activity to be detected. 6. In the D dialog, the upper portion shows the ECoG in the selected channel. EFINE ATTERNS Touch on the point of the ECoG where you would like detection to occur. Starting from the point where you touch, a 3-second window of time (or region of interest, ROI) is bracketed on the ECoG.
- Page 55 Tablet Instructions • Normally you want to touch near the beginning of the pattern in order to define a pattern that will be detected promptly after it begins. Detection settings should promptly detect ECoG activity and not detect on baseline activity. The software automatically applies a suggested detector (shown in the D field) and ETECT...
-
Page 56: Phase 3: Customize Pattern Detection
Tablet Instructions Figure 34 Detection settings ready to be saved Note: ECoG capture triggers are inactive during programming. Programming clears activity information and ECoGs stored in the neurostimulator. If there is any new information, be sure to interrogate the neurostimulator prior to programming. 8. - Page 57 Tablet Instructions 1. Select N from the H screen, EUROSTIM ETTINGS 2. On the N screen, select P at upper center. The EUROSTIM ETTINGS ATTERN ETECTION screen opens. ATTERN ETECTION Figure 35 Pattern Detection screen • The N field at upper left identifies the currently active detection set, as indicated by ) next to the field.
- Page 58 Tablet Instructions Figure 36 Define Patterns dialog 4. In the D dialog, select and adjust the desired parameter using the sliders so EFINE ATTERNS as to increase or decrease how early and how often the pattern is detected. The software automatically simulates detection with the changed parameter as applied to this ECoG and to the patient’s other stored ECoGs shown in smaller size below.
- Page 59 Tablet Instructions Figure 37 Detection simulation in all ECoGs • To hide the simulation on the ECoG, select H . To remove the pattern on the ECoG, select LEAR • Detection parameters that affect sensitivity are key: adjustments that increase sensitivity tend to increase how early and how often the pattern is detected;...
-
Page 60: Detection
Tablet Instructions • After changing detection settings, the N screen has a R button next EUROSTIM ETTINGS EVERT to the S button. Select R if you want to remove all changes to the detection settings EVERT and revert to the current detection set. ETECTION OOLS AND ETECTORS... -
Page 61: Power Change Detector
Tablet Instructions Detection Tool Detectors Used With OWER HANGE Power Change FORMERLY ENGTH Rhythmic Activity and Spike Activity ANDPASS 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 be stretched so the length can be measured. - Page 62 Tablet Instructions The ECoG in the bottom of Figure 39 below shows a developing seizure that corresponds in time with the short-term power change trend line (red) and the long-term power change trend line (blue). The power change detector works by comparing the normalized ECoG length (length per second) in a short-term trend window (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).
-
Page 63: Rhythmic Activity Detector
Tablet Instructions Rhythmic Activity Detector The Rhythmic Activity detector provides highly specific and early detection of rhythmic activity within a defined bandwidth. It acts like a frequency filter and can therefore be used to detect activity within specific frequency bands (theta, alpha, beta, and gamma). To understand how the Rhythmic Activity detector works refer to Figure 40. -
Page 64: Spike Activity Detector
Tablet Instructions Spike Activity Detector The Spike Activity detector functions in a manner very similar to the Rhythmic Activity detector, but it is optimized for the faster transients that comprise spikes. To understand how the Spike Activity detector works refer to Figure 41. Figure 41 Spike Activity detector example The Spike Activity detector analyzes the ECoG to determine when a signal is present within a specified bandwidth that meets specified amplitude and duration requirements. -
Page 65: Bandpass Detection Tool
Tablet Instructions Bandpass Detection Tool The Bandpass detection tool provides highly specific 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, and gamma). The R and S HYTHMIC CTIVITY... -
Page 66: Area Detection Tool
Tablet Instructions Area Detection Tool The A detection tool can be selected only manually from the D dialog (select EFINE ATTERNS > A ). It is not used as a suggested detector by the software. The A ONTROLS ONTROLS detection 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 short- term trend window (typically 1 to 4 seconds) to the normalized ECoG area in a long-term trend... -
Page 67: Advanced Controls
Tablet Instructions Advanced Controls The physician has access to advanced controls from the D dialog. Select M EFINE ATTERNS > A to open the A dialog for the pattern you are currently ONTROLS ONTROLS DVANCED ETTINGS defining, which gives access to additional settings for the detection tools B ANDPASS OWER HANGE... -
Page 68: Shandre Andnd / Or Downloandd And Detection Set
Tablet Instructions HARE AND OWNLOAD A ETECTION This section explains how to share a detection set with the users or programmers you select, and how to download a shared detection set. For example, use this feature when more than one physician is treating a patient. - Page 69 Tablet Instructions 2. You can select to share with: a. A specific user, who could then access it on any programmer to which he is logged in. Touch the S field to select from a list of available usernames, if any. HARE WITH USER (Available usernames would include those users who have been logged in to a programmer while interrogating the neurostimulator associated with the patient to which...
-
Page 70: Steps To Download A Detection Set To The Tablet
Tablet Instructions Steps to Download a Detection Set to the Tablet To download a detection set and save it locally to the tablet for offline use, follow these steps: Figure 47 Start screen 1. Select the P tile on the tablet Start screen. The patient list opens. ATIENT 2. - Page 71 Tablet Instructions Figure 49 Pattern Detection screen 4. Select the N field and select the name of detection set you want to download to the tablet. 5. Select the S button. The S dialog opens, but in this case, it includes a HARE HARE ETECTION...
- Page 72 Tablet Instructions Figure 51 The S dialog with download now option selected HARE ETECTION 7. Select the S button. A download progress dialog appears briefly, and when download is HARE complete, a PDMS Transfer message reports “The detection set download has completed successfully and will be available in offline mode.”...
-
Page 73: Overview Of Responsive Therapy
Tablet Instructions VERVIEW OF ESPONSIVE HERAPY ® The RNS Neurostimulator can deliver a therapy sequence of up to 5 individually configured therapies in response to detected activity. The neurostimulator resumes sensing after each therapy is delivered. If the activity is still detected, the next (sequential) therapy is delivered. If the activity is no longer detected, the remaining therapies are not delivered and the episode ends. -
Page 74: Configure Responsive Therapy
Tablet Instructions The following figure identifies the parameters of a burst of stimulation therapy. Figure 55 Parameters of a single burst of stimulation ONFIGURE ESPONSIVE HERAPY Detection must be enabled before responsive therapy can be enabled. Before programming responsive therapy, at least one detector must be defined in a detection set. (If you 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 to an episode. - Page 75 Tablet Instructions 1. Select N from the H screen. EUROSTIM ETTINGS 2. Select S at upper center of the N screen. The S TIMULATION EUROSTIM ETTINGS TIMULATION screen opens. (Swipe left to see the right side.) Figure 56 Stimulation screen, left side. Swipe left to see right side. The screen has rows S 1 through S 5 to program up to five stimulation therapies.
- Page 76 Tablet Instructions only 2 channels, then the stimulation pathway should be configured such that current is delivered through only those electrodes with electrographic activity of interest. 4. Select the level of C to be delivered during pulses. URRENT 5. Select the PW P , which is the pulse width or duration (in µs) of each phase of the HASE biphasic current pulse.
- Page 77 Tablet Instructions 9. If desired, select T at upper right to adjust the maximum number of HERAPY IMIT PER episodes the neurostimulator will treat per day. 10. If desired, swipe left to access the O area on the right side of the N PTIONS EUROSTIM ETTINGS...
-
Page 78: Optional Advanced Settings
Tablet Instructions Optional Advanced Settings If desired, select A at far right to open the A screen for the selected DVANCED DVANCED ETTINGS therapy (S row). By default, all advanced settings are disabled. Figure 59 Stim 1 Advanced Settings ® System Programming Manual... - Page 79 Tablet Instructions The A screen has upper, lower and bottom portions that let you select the DVANCED ETTINGS following: Upper portion—Adaptive Therapy: Adapts the frequency and the minimum amplitude of the stimulation therapy as a percentage of the detected signal amplitude over a chosen channel, for one or both bursts.
- Page 80 Tablet Instructions Illustration: If A = 100% and the detected signal frequency = 20 Hz (50 DAPT MPLITUDE ms period), the stimulation frequency is delivered at 20 Hz (50 ms p-p interval). If = 50% and the sensed signal frequency = 20 Hz (50 ms DAPT MPLITUDE period), the stimulation frequency is delivered at 40 Hz (25 ms p-p interval).
-
Page 81: Test Stimulation Before Enabling
Tablet Instructions Figure 62 Post-episode interval settings—bottom portion of Advanced Settings dialog Save Advanced Settings: Select D to save the new advanced settings and return to the screen. TIMULATION Test Stimulation Before Enabling Before enabling responsive therapy, it is important to test stimulation to make sure it is well tolerated by the patient and there are no undesired changes in the ECoG, such as afterdischarges. -
Page 82: Enable Therapy: Review & Program
Tablet Instructions • Test stimulations should be delivered to each electrode individually (electrode to neurostimulator) to determine whether there are acute side effects from stimulation. • Habituation to side effects resulting from stimulation has been observed; however it is not advised to program settings that cause patient discomfort. -
Page 83: Recommended Initial Responsive Therapy Settings
Tablet Instructions The P dialog shows programming progress until complete. ROGRAMMING NEUROSTIMULATOR Figure 65 Programming neurostimulator dialog shows progress of programming Recommended Initial Responsive Therapy Settings Responsive stimulation therapy should be enabled once the physician has determined the electrographic activity of interest is being detected. •... -
Page 84: Recommended Therapy Modifications After Observing Clinical Response
Tablet Instructions Recommended Therapy Modifications After Observing Clinical Response Once the neurostimulator is programmed to provide responsive stimulation, the patient should be seen at approximately 3-month intervals to determine whether detection and/or responsive therapy settings should be modified. At each patient visit, the physician reviews ECoGs that are stored on the PDMS or programmer. -
Page 85: Export And Import Device Settings For Neurostimulator Replacement
Tablet Instructions XPORT AND MPORT EVICE ETTINGS FOR EUROSTIMULATOR EPLACEMENT The tablet supports the transfer of all device settings from an old to a new neurostimulator as part of a neurostimulator replacement procedure. With the E and I functions, XPORT EVICE ETTINGS MPORT... -
Page 86: Import Neurostimulator Settings
Tablet Instructions Import Neurostimulator Settings 1. Interrogate the new neurostimulator, the one to which you will transfer settings. 2. Select the U (toolbox) icon at upper right. The U dialog opens (see figure above). TILITIES TILITIES 3. Select I . The I dialog appears. - Page 87 Tablet Instructions 5. Select R & P . The R screen opens, showing all the settings that will be EVIEW ROGRAM EVIEW programmed. • If you want to enable detection and stimulation at this time, make sure D ETECTION are set to E at upper center.
-
Page 88: Patient List On Tablet And The Pdms On A Personal Computer
Patient List on Programmer and the PDMS on a PC PDMS ATIENT IST ON ABLET AND THE ON A ERSONAL OMPUTER The P on the tablet and the PDMS on a personal computer give access to stored data for a ATIENT selected patient. -
Page 89: Pdms Access On A Personal Computer
Access to the secure PDMS database on a personal computer requires a username and password. If NeuroPace has not already provided these to you, contact NeuroPace to obtain a username and temporary password. You are responsible for maintaining the confidentiality of your username and password. - Page 90 Patient List on Programmer and the PDMS on a PC 1. To reach the P on the tablet, select P from the Start screen. The ATIENT ATIENT screen opens. When you log in to the PDMS via a web browser, it opens ATIENT directly on the P screen.
- Page 91 Patient List on Programmer and the PDMS on a PC 3. Select a tile to view its associated data for this patient. • & N ATIENT EUROSTIM • EUROSTIM ETTINGS • CTIVITY • IBRARY • You can switch between patient views or return to the P screen by touching the ATIENT screen title at upper left (or the down arrow next to it).
-
Page 92: Patient & Neurostim Info
Patient List on Programmer and the PDMS on a PC & N ATIENT EUROSTIM Figure 74 Patient & Neurostim Info screen This screen provides: • At upper left, patient information. • At lower left, whether D and S are E or D ETECTION TIMULATION... - Page 93 Patient List on Programmer and the PDMS on a PC • When accessing the PDMS via a web browser (not via the tablet), you can define or edit and save a detection set to the PDMS, and later download the detection set to the programmer.
-
Page 94: Activity
Patient List on Programmer and the PDMS on a PC • screen: This screen reports the current capture settings. You cannot adjust APTURE them here. You can adjust ECoG capture settings only using the tablet during an interactive programming session. See Set up ECoG Capture on page 38. Figure 76 ECoG Capture screen through the patient list—review current settings only CTIVITY The A... -
Page 95: Patient Follow-Up Activities
Patient Follow-Up Activities ATIENT OLLOW CTIVITIES The following activities are recommended at a follow-up visit: • ® ® Interrogate the RNS Neurostimulator. See Interrogate the RNS Neurostimulator on page 16. • Review measured battery voltage and electrode impedance on the Neurostim Info Screen— see page 20. -
Page 96: Troubleshooting
NeuroPace Remote Monitor, see the NeuroPace Remote Monitor Manual. If the information in this section does not resolve the problem, contact NeuroPace for further assistance (see Contacting NeuroPace on page 4). Network Connectivity Problems For an overview and step-by-step instructions to establish full network connectivity with the tablet, see Connect and Login Overview on page 10 and following. - Page 97 Troubleshooting • Disconnect leads, place leads in the opposite connector cover ports, and reconnect the connector cover and neurostimulator according to the instructions in the relevant section of the system manual. • Program the new lead information and montage and use the same electrode labels for the new lead configuration.
- Page 98 Troubleshooting Troubleshooting During a Routine Follow-up 1. Repeat lead impedance measurements to verify abnormal lead impedance. 2. Take an image (X-ray or CT scan) of the implanted lead(s) and connector cover to discern the integrity of the lead. • Lead Damage – If the lead is damaged or fractured, it is recommended to abandon and replace the lead.
-
Page 99: Insufficient Charge
“Programmed current” is higher than the “Lowest delivered” current, contact your NeuroPace Field Clinical Engineer. The NeuroPace Field Clinical Engineer will help you review the neurostimulator configuration settings to determine the cause. An example interrogation report is shown below in Figure 77. -
Page 100: Poor Or No Communication Between The Rns Neurostimulator And The Rns Tablet
Troubleshooting 6. Remove the leads from the connector cover. Clean the proximal end of the lead with saline and visually inspect that the lead end is free of excess blood or other tissue. 7. Reinsert the leads. Verify that they are fully inserted into the connector cover ports. ®... -
Page 101: Tablet Does Not Turn On
3. Restart the tablet: Press and hold down the power button for four (4) seconds. After 2-3 seconds, the tablet beeps to indicate it is powering on. If the tablet does not restart, follow these instructions again. If the tablet still does not start, contact NeuroPace for further assistance (see Contacting NeuroPace on page 4). -
Page 102: Specifications And Characteristics
Specifications and Characteristics PECIFICATIONS AND HARACTERISTICS ® ABLET ® Tablet, Model 5000 Wand, Model W-02 Width: 29 cm Height: 21 cm 18 cm x 9 cm IMENSIONS Depth: 1 cm Commercial Materials ABS copolymer ATERIAL 0.86 kg 240 g EIGHT 0 °C to 40 °C 0 °C to 35 °C PERATING... -
Page 103: Rns ® System Wireless
Specifications and Characteristics ® YSTEM IRELESS Transfer data between the neurostimulator and IRELESS UNCTION the programmer or remote monitor and wand: interrogation, programming and live ECoGs Short range, low power inductive coil to coil IRELESS ECHNOLOGY telemetry Clinical setting and home environment NTENDED NVIRONMENT 0 –... -
Page 104: Home, Work Or Public Environments
For additional information about devices that generate electromagnetic interference contact NeuroPace (see Contacting NeuroPace on page 4). If a patient suspects EMI is disrupting the operations of their neurostimulator, advise the patient to move away from the source of the EMI. -
Page 105: Emissions And Immunity Information
Specifications and Characteristics • Remote Monitor, models DTR-300 and DTR-300-E, and 5100 The devices comply with IEC 60601-1-2, ISO 14708-3, and FCC 47 CFR Parts 2 and 15. • Portable and mobile RF communications equipment can affect the device. • This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. - Page 106 Specifications and Characteristics Table 2. Guidance and manufacturer’s declaration – electromagnetic immunity – for all equipment and systems Immunity test Compliance level Electromagnetic environment – guidance Floors should be wood, concrete or Electrostatic discharge ±2, 4, 6, 8kV contact discharge ceramic tile.
- Page 107 Specifications and Characteristics Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life supporting Immunity Test Compliance Level Electromagnetic environment – guidance Portable and mobile RF communications equipment should 3 Vrms ® be used no closer to any part of the RNS System, 150 KHz to 80 MHz...
- Page 108 Specifications and Characteristics Table 4. Recommended separation distances between portable ® a, b, c and mobile RF communications equipment and the RNS System Separation distance according to frequency of transmitter (m) Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz of transmitter...
-
Page 109: Glossary
Glossary LOSSARY Adapt Channel. The adapt channel is an advanced responsive therapy setting. The neurostimulator will monitor this channel from which to calculate the adaptive stimulation frequency. This channel is used for all adaptive bursts. Adapt Min Amplitude. The percentage of the detected signal amplitude to be used as the minimum therapy amplitude. - Page 110 Connector Plug. The connector plugs are used to fill any ports on the connector head of the neurostimulator that are not in use. ® Cortical Strip Lead. The NeuroPace Cortical Strip Lead lies on the surface of the brain (cortex) and can detect the electrical activity of the brain and deliver stimulation.
- Page 111 Glossary Frequency. The frequency is the rate at which pulses are delivered which is expressed in Hz (pulses/second). Gain. ECoG signal amplification on one channel of the neurostimulator. Impedance Measurement. The opposition of current flow between electrodes as determined by measuring the voltage (Ohms) resulting from the delivery of a current pulse.
- Page 112 When the type of reset is recoverable, the programmer displays instructions to recover, which typically guide you to reprogram the neurostimulator. If the reset is not recoverable, or if recovery is unsuccessful, note the cause of the reset and contact NeuroPace (see Contacting NeuroPace on page ®...
- Page 113 Glossary Simulate Performance. Simulation uses the programmer to test a proposed set of detection settings with retrieved ECoGs. The simulation will generate markers, simulating how the neurostimulator may detect if those settings are programmed into the neurostimulator. Start Time. Scheduled storage setting controlling the time(s) at which ECoG capture will be triggered. Stereotactic Frame.
-
Page 114: Index
Connect to the Internet, 10, 11, 23, 29, 48, 92 Artifacts, 35, 92, 93, 95, 96 Connectivity Problems, 92 field, 31 SSIGN ATEGORY Contacting NeuroPace, 5 Assign Channels, 35 button, 47, 55 ONTINUE button, 15 Create the Recording Montage, 32... - Page 115 Index , 75 ECoGs—Live, 31, 35 EFAULT HERAPY REQUENCY Define a Pattern Detection Set, 48 Electrode 1 is most distal, 33 Define and Modify Detection Settings, 44 Electrode Impedance, 22 dialog, 50, 53 electrodes numbered 1 through 4, 33 EFINE ATTERNS , 76 Electromagnetic Emissions and Immunity, 99...
- Page 116 Interference, RFID—warning, 6 field, 48, 53 Interference—caution, 8 Network Connectivity Problems, 92 Internet connection, 11, 23, 29, 48, 92 panel, 12 ETWORKS Interrogation, 16 NeuroPace components—warning, 7 , 35 , 24 NTERVAL EUROSTIM VENTS date, 20 Neurostim Info Screen, 20...
- Page 117 Index Pattern Detection Phase 2, 48 Recommended Initial ECoG Capture Settings, Pattern Detection Phase 3, 52 Recommended Initial Montage Settings, 35 screen, 53, 88 ATTERN ETECTION Recommended Initial Responsive Therapy A1 & B1, 48, 53 ATTERNS Settings, 79 A2 & B2, 48, 53 ATTERNS Recommended Therapy Modifications After PDMS login, 10, 15...
- Page 118 Index Set Capture Duration, 40 Tablet Wireless Specifications, 98 Set Capture Triggers, 40 , 63 ECHNICAL ARAMETERS Set Gain, 35 Test Stimulation Before Enabling, 77 button, 64 screen, 77 HARE TIMULATION signal level, 17 Therapy Configuration, 70 , 75 signal quality, 17 HERAPY REQUENCY ULTIPLIER...
- Page 120 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 ® System Programming Manual...