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Neuropace RNS System User Manual

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®
RNS
System User Manual
© 2019 NeuroPace, Inc.
Rev Date: 2019-01
DN 1017309 Rev 4

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Summary of Contents for Neuropace RNS System

  • Page 1 ® System User Manual © 2019 NeuroPace, Inc. Rev Date: 2019-01 DN 1017309 Rev 4...
  • Page 2 IMPORTANT: Changes or modifications to this product not expressly approved by NeuroPace, Inc. could void the FCC Certification, and negate your authority to operate them. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.

  • Page 3: Table Of Contents

    Table of Contents TABLE OF CONTENTS INTRODUCTION ............................5 .......................... 5 ONTACTING EURO ........................... 5 BOUT THIS ANUAL ® SYSTEM ............................. 8 ............................... 8 NDICATIONS ........................... 8 ONTRAINDICATIONS ........................8 ARNINGS AND RECAUTIONS ® ........................18 MPLANTED YSTEM ® ........................18 YSTEM ESCRIPTION ®...

  • Page 4: Table Of Contents

    Table of Contents Entering Patient Information into the Programmer ................59 Entering Physician Emergency Contact Information ................59 Programming Information ........................59 ................59 SSIGNING ABELS AND REATING THE ONTAGE Assigning the Lead Labels ......................... 59 Recommended Initial Lead Labels ..................... 61 Creating a Montage ..........................
  • Page 5 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Caution Do Not Resterilize MR Unsafe Prescription Only Non-Pyrogenic Single Use Sterilized Using Ethylene Oxide Temperature limits during use Temperature limits during storage or transport Storage Manufacturer Serial number...
  • Page 6 Class II electrical protection Direct current (DC) 5 V (volts), 0.5 A (amperes) Ingress protection ratings: Level 2 for solid objects, which means testing confirms the device enclosure prevents ingress (entry) of items greater than 12.5 mm (~1/2 inch), such IP22 as fingers or similar objects;...

  • Page 7: Introduction

    Introduction NTRODUCTION ONTACTING EURO ® ® All questions or concerns regarding the NeuroPace System should be forwarded to: NeuroPace, Inc. 455 N. Bernardo Ave. Mountain View, CA 94043 Customer Support: 1-866-726-3876 (Toll Free in the United States) Fax: 650-237-2855 Website: www.NeuroPace.com...
  • Page 8 Statements regarding a figure are located below the figure between double lines such as this. Bold italicized text refers the user to a specific location in this manual for further details. ® assist the user in navigating to the appropriate tab or button on the NeuroPace MALL Programmer screen.
  • Page 9 Introduction ® The tabs are displayed on the NeuroPace Programmer screen as follows: Page Button ® System User Manual...

  • Page 10: Rns ® System

    Patients who have medical devices implanted that deliver electrical energy to the brain. • Patients who are unable, or do not have the necessary assistance, to properly operate the • ® NeuroPace Remote Monitor or magnet. ® The following medical procedures are contraindicated for patients with an implanted RNS System.
  • Page 11 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 12 Responsive Neurostimulator System head trauma, anticoagulant use, or who experience head injury with seizures should be taken into specific consideration. WARNING: URGICAL ROCEDURE FFECTS Surgical procedure risks may include, but are not limited to, temporary pain at the implant site, CSF leakage and although rare, epidural hemorrhage, seroma, subdural or epidural hematoma and paralysis.
  • Page 13 Responsive Neurostimulator System Electromagnetic interference is a field of energy generated by equipment found in the home, work, medical, or public environments that is strong enough to interfere with neurostimulator function. Sources of strong electromagnetic interference can result in the following effects: •...
  • Page 14 Electrical shock may occur if the programmer AC adapter and power cord are not properly connected to a grounded power source. Do not attempt to modify or repair the wand or programmer. Contact NeuroPace Customer Support for assistance. WARNING:...
  • Page 15 Responsive Neurostimulator System System. This could result in loss of therapy, and additional surgery to remove or ® replace components of the RNS System. Prior to any administration of lithotripsy, the ® administering physician should consult with the physician prescribing the RNS System.
  • Page 16 Responsive Neurostimulator System – S RECAUTIONS URGICAL Precaution: Connector Plug A vacant port in the connector cover must be filled with a connector plug (provided in the connector cover kit). There is an increased risk of neurostimulator failure if a connector cover port is vacant.
  • Page 17 Responsive Neurostimulator System Precaution: Explantation and EMI Considerations If any system components (neurostimulator, leads, lead fragments, or cranial prosthesis) remain implanted in the patient after a partial system explant, the patient is still susceptible to possible adverse effects from strong sources of EMI. It is possible for the interference sources to couple enough energy into a neurostimulator system to damage brain tissue, resulting in serious patient injury or death.
  • Page 18 Incompatibility of NeuroPace Programmer with Other Medical Devices ® The effects of using the NeuroPace Programmer to interrogate other electronic, programmable devices such as pacemakers, defibrillators, cochlear implants, and other neurostimulators or CPAP machines are unknown. It could result in...
  • Page 19 Responsive Neurostimulator System Precaution: Electronic Interference Communications between the programmer and the implanted neurostimulator may be interrupted by emissions from nearby electronic devices. Examples of sources of EMI are lithotripsy, computer monitors, cellular telephones, motorized wheel chairs, x-ray equipment and other monitoring equipment. Interruption of telemetry can result in incomplete communication.

  • Page 20: Implanted Rns ® System

    System Products The sterile, implantable products are the ® • Neurostimulator ® ® • NeuroPace Cortical Strip Lead(s) and NeuroPace Depth Lead(s) • Implantable components and accessories ® External RNS System Products The non-sterile, external products are the ® •...
  • Page 21 Remote Monitor (laptop computer with proprietary software) and telemetry component (wand model W-02) used by the patient to gather information from the implanted ® ® Neurostimulator and upload it to the NeuroPace Patient Data Management System. For additional information, refer to the remote monitor user manual. •...
  • Page 22 Responsive Neurostimulator System Theory of Operation ® The RNS Neurostimulator and implanted intracranial leads are designed to monitor electrical activity of the brain and deliver therapy in the form of electrical stimulation when appropriate. The neurostimulator is implanted in the patient and communicates with the programmer (and remote monitor).

  • Page 23: Rns ® Neurostimulator

    Neurostimulator, NeuroPace Cortical Strip Lead, and ® NeuroPace Depth Lead are not compatible with non-NeuroPace leads and / or pulse generators. Incompatible configurations may cause damage to the products and may result in unsafe current densities delivered to the patient. ®...

  • Page 24: Neuro Pace ® Cortical Strip Lead

    Neurostimulator, NeuroPace Cortical Strip Lead, and ® NeuroPace Depth Lead are not compatible with non-NeuroPace leads and / or pulse generators. Incompatible configurations may cause damage to the products and may result in unsafe current densities delivered to the patient. ®...

  • Page 25: Lead Component And Accessories

    ROGRAMMER ® NeuroPace Programmer (Model PGM-300) The programmer includes a laptop personal computer that runs software developed by NeuroPace, ® and uses custom telemetry components to communicate with the RNS Neurostimulator by holding the wand over it. The wand is a applied to the patient (an applied part).

  • Page 26: Telemetry Wand

    Responsive Neurostimulator System ® ® Figure 4: The NeuroPace Programmer and wand are used to communicate with the RNS Neurostimulator. ELEMETRY Wand (Model W-02) ® The wand is applied to the patient (an applied part), placed over the implanted RNS Neurostimulator to facilitate communication with the programmer.

  • Page 27: Sterilization , Storage , And Handling

    Return / Disposal of Programmer and Wand The programmer and wand should be returned to NeuroPace if you are no longer using them. They contain electrical parts that need to be disposed of in accordance with local regulations.

  • Page 28: Rns ® System Longevity

    Responsive Neurostimulator System programmer may experience telemetry artifacts or errors, or may freeze. In the event of a programmer freeze, refer to the troubleshooting section. ® YSTEM ONGEVITY ® Neurostimulator Battery Neurostimulator longevity depends on the amount of stimulation delivered to the patient. Each time the neurostimulator delivers stimulation, a small amount of charge is drained from the battery.
  • Page 29 Responsive Neurostimulator System Patient Use Profiles Medium High Parameter Unit Percentile) Percentile) Percentile) Current Frequency Pulse Width µsec Burst Duration msec Bursts per day 1330 Elective Replacement Indication (ERI) The programmer reports the neurostimulator battery voltage each time it is interrogated. The elective replacement indicator is displayed upon interrogation of the neurostimulator.

  • Page 30: Product Registration

    Registration of implanted medical products is required by U.S. federal regulations. A registration form ® is provided with the RNS Neurostimulator and leads. Complete the registration information as soon as possible and return it to NeuroPace. ® System User Manual...

  • Page 31: Clinical Use Of The Rns ® System

    System is appropriate only in patients whose seizures begin in one or two foci that can be ® ® implanted with NeuroPace Depth Leads and/or NeuroPace Cortical Strip Leads. Only 2 leads can be connected to the neurostimulator and therefore detection and stimulation can occur in no more than 2 locations.

  • Page 32: Patient Training

    RAINING ® • Prior to the implant surgery, train the patient and / or caregiver how to use the NeuroPace Remote Monitor and wand, as well as how to use the magnet to mark clinical seizures. • After implantation, provide the patient with the medical implant identification card.

  • Page 33: Recommended Initial Responsive Therapy Settings

    ® Clinical Use of the RNS System example, channel 1 should be programmed to sense the difference between electrode 1 on lead 1 and electrode 2 on lead 1. The recommended initial detection settings are the default settings in the programmer. These settings detect changes in frequency and power of the ECoG (line Length detector with a 75% threshold).

  • Page 34: Modifying Detection And Responsive Therapy Settings

    ® Clinical Use of the RNS System Modifying Detection and Responsive Therapy Settings 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 35: Surgical Procedures

    Implanting physicians should have adequate experience in the implantation of subdural and stereotactic implantation of intraparenchymal electrodes, in the surgical treatment of intractable epilepsy, have ® ® completed the NeuroPace System training program, and be thoroughly familiar with all product labeling. MPLANT Patient and Family Information ®...
  • Page 36 If interrogation fails or the EASURED ATTERY OLTAGE battery voltage is < 2.85 V, return the neurostimulator to NeuroPace, and continue the procedure with another sterile, packaged neurostimulator. To manually measure battery voltage after interrogating: 1. Go to the R tab.

  • Page 37: Recommended Implant Procedure Flow Chart

    Surgical Procedures ECOMMENDED MPLANT ROCEDURE HART Depth Lead Implant Cortical Strip Lead Implant Neurostimulator Implant Make Burr Hole at appropriate location to implant Depth Lead Attach Burr Hole Cover Perform appropriate craniotomy Make scalp incision at the desired implant location base to skull to implant Cortical Strip Lead Advance insertion cannula...

  • Page 38: Recommended Neuro Pace ® Depth Lead Implantation And Fixation

    Surgical Procedures ® ECOMMENDED EURO EPTH MPLANTATION AND IXATION Burr Hole Placement 1. Make an incision in the scalp at or near the desired burr hole location. 2. Using a standard perforator, create a 14 mm burr hole in the skull. 3.
  • Page 39 Surgical Procedures 2. Before placing the insertion cannula onto the frame, insert the depth lead into the insertion cannula and place the stop gauge (provided) on the lead directly above the cannula, such that the lead tip will reach the implant target after the lead is fully advanced down the cannula.
  • Page 40 Surgical Procedures Figure 9: Removal of the insertion cannula, stylet, and stylet retainer from the lead. 4. Leave approximately 10-15 mm of the lead inside the burr hole, allowing slack in the lead before securing the lead to the skull. 5.

  • Page 41: Recommended Neuro Pace ® Cortical Strip Lead Implantation And Fixation

    Surgical Procedures ® ECOMMENDED EURO ORTICAL TRIP MPLANTATION AND IXATION Cortical Strip Lead Insertion Note: The cortical strip lead may be implanted in a manner similar to standard strip lead implants. 1. Make an incision in the scalp at or near the craniectomy location. 2.

  • Page 42: Recommended Rns ® Neurostimulator Implantation Procedure

    Surgical Procedures ® ECOMMENDED EUROSTIMULATOR MPLANTATION ROCEDURE Craniectomy Placement The recommended location of the neurostimulator is in the parietal skull. However, the neurostimulator may be implanted anywhere in the skull in a position that achieves a good contoured fit and allows the neurostimulator to sit flush with the cranial surface. The neurostimulator can be inserted into the ferrule in only one orientation and the leads exit the connector cover from only one direction.
  • Page 43 Surgical Procedures 1. Make a scalp incision at the desired neurostimulator implant location. 2. Trace the craniectomy template on the skull at the implant location. 3. Using a standard perforator, perform a craniectomy around the outside edge of the template tracing.
  • Page 44 Surgical Procedures Figure 11: The four ferrule tabs secured to the skull with bone screws. 8. Flush the craniectomy and ferrule. 9. Place the neurostimulator in the ferrule. 10. Rotate the ferrule clamp so that it engages the neurostimulator then fully tighten the ferrule clamp screw until the torque driver clicks (Figure 12).
  • Page 45 Surgical Procedures Figure 12: The ferrule clamp securing the neurostimulator to the ferrule. Precaution: Scalp Necrosis ® Protrusion of the implanted RNS System products above the surface of the skull may cause necrosis of the scalp. ® System User Manual...

  • Page 46: Connecting The Rns ® Neurostimulator To The Implanted Lead ( S )

    Surgical Procedures ® ONNECTING THE EUROSTIMULATOR TO THE MPLANTED Tunneling with the Tunneling Tool 1. Remove the temporary cover from the end of the tunneling tool (with tip remaining on the opposite end of the cover). 2. Slide the tunneling tool through the tunneling tool straw. 3.
  • Page 47 Surgical Procedures 4. Advance the lead from the burr hole to the craniectomy, allowing the proximal lead contacts and lead body to extend from the craniectomy. 5. Remove the tunneling tool straw. Note: Leave sufficient slack in the lead adjacent to skull fixation points to relieve stress on the lead. Securing the Neurostimulator and Lead(s) 1.
  • Page 48 Surgical Procedures 5. If using only one lead, be sure to place a connector plug in the vacant connector cover port. Connector plug Figure 15: Neurostimulator connector cover with a connector plug placed in the one vacant port. Precaution: Connector Plug A vacant port in the connector cover must be filled with a connector plug (provided in the connector cover kit).
  • Page 49 Surgical Procedures Lead strain relief ® Figure 16: Secure the connector cover and lead(s) to the RNS Neurostimulator using the torque driver. 10. Place the lead strain relief over the proximal ends of the leads extending from the connector cover (Figure 16) and attach it to the post. 11.

  • Page 50: Replacing / Explanting The Rns ® System

    Return the explanted neurostimulator to NeuroPace. Contact NeuroPace to obtain shipping containers. • Dispose of all product not returned to NeuroPace by adhering to local governing agency recommendations. • Do not incinerate or cremate the neurostimulator. Explosion may occur when exposed to extreme heat.
  • Page 51 90 degrees away from the neurostimulator to facilitate removal of the neurostimulator. 9. Remove the neurostimulator from the ferrule. Note: Return the explanted neurostimulator and leads to NeuroPace. NeuroPace will provide shipping containers if requested. 10. Flush the craniectomy and ferrule.
  • Page 52 Surgical Procedures 20. Place the connector cover on the neurostimulator and then loosely attach it to the neurostimulator using the torque driver. Ensure that the leads remain completely inserted in the connector cover. Note: DO NOT use any tools other than the torque driver provided to secure the connector cover in place.

  • Page 53: Changing The Leads That Are Connected To The Neurostimulator

    8. Remove the neurostimulator from the ferrule. Note: Return the explanted neurostimulator and leads to NeuroPace. NeuroPace will provide shipping containers if requested. 9. Remove the proximal lead ends from the connector cover.
  • Page 54 Surgical Procedures 4. Clear tissue and bone debris away from the area surrounding the neurostimulator and lead strain relief area. 5. Remove the lead strain relief from the neurostimulator and dispose. 6. Use the torque driver to loosen and remove the connector cover. 7.
  • Page 55 Surgical Procedures 22. Select the desired amplifier (sensing) channels on the M tab (under C ONTAGE ONFIGURE ) of the programmer. Program the information into the neurostimulator. ETTINGS 23. View real-time ECoG signals on the R tab (under R tab) and EVIEW measure lead impedance(s) (under M tab) to ensure proper connection...

  • Page 56: Programming Instructions

    Programming Instructions ROGRAMMING NSTRUCTIONS ® OGGING ONTO THE EURO ROGRAMMER 1. Connect the wand to the USB port on the programmer. 2. Connect the AC adapter to the programmer and to the power cord. 3. Plug the power cord into a grounded power outlet. 4.

  • Page 57: Impedance Measurements

    Programming Instructions MPEDANCE EASUREMENTS Impedance measurements are useful for verifying the integrity of a particular electrode. Each impedance measurement delivers a single pulse of current between an electrode and the neurostimulator canister (can) to measure the voltage that results as the current flows. Impedance measurements are reported in Ohms (voltage divided by current).

  • Page 58: Obtaining Neurostimulator Activity Information

    Programming Instructions Viewing Real-time ECoGs 1. Keep the wand in place over the neurostimulator. 2. Go to R tab. EVIEW 3. Select the R tab. Storing a Real-time ECoG 1. Select the S button to stop the ECoG from scrolling. 2.

  • Page 59: Delivering Test Stimulations

    Programming Instructions Each ECoG stored is listed with the reason for storage (trigger) and detected events are displayed over the captured ECoG signal. It is recommended that stored ECoGs be reviewed to assess the electrographic response to neurostimulator-delivered therapies. Note: A full history of stored ECoGs is available on the PDMS.

  • Page 60: Synchronizing The Programmer With The Neuro Pace ® Patient Data Management System

    ATIENT ANAGEMENT YSTEM ® The programmer should be synchronized with the NeuroPace Patient Data Management System (PDMS) upon neurostimulator reprogramming or collection of new neurostimulator data. Database synchronization sends a copy of the neurostimulator interrogation and programming information stored on the programmer to the PDMS.

  • Page 61: Emergency Contact

    Programming Instructions ATIENT NFORMATION AND HYSICIAN MERGENCY ONTACT NFORMATION Entering Patient Information into the Programmer 1. Go to the P tab. ATIENT RODUCT 2. The user should enter the following information for each patient: • ATIENT DENTIFIER • ENDER • ATE OF IRTH Entering Physician Emergency Contact Information...
  • Page 62 Programming Instructions ® Figure 19: RNS Neurostimulator port #1 and #2 locations. Port #1 is located towards the center of the neurostimulator and port #2 is closer to the edge. Note: Additional leads implanted may be recorded in the comments field. 3.

  • Page 63: Recommended Initial Lead Labels

    Programming Instructions Recommended Initial Lead Labels • Name the leads on the P ATIENT RODUCT Enter meaningful names for each lead; for example, a lead in the left hippocampus can be • labeled “LHip.” Figure 21: Patient/Product tab. ® System User Manual...

  • Page 64: Creating A Montage

    Programming Instructions Creating a Montage 1. Go to the C tab. ONFIGURE ETTINGS 2. From the M screen, assign an electrode to each C (CH1 through CH4) by ONTAGE HANNEL selecting either a non-inverting (+) or inverting (-) input. Each electrode can be assigned to one or two channels.

  • Page 65: Programming The Newly Selected Settings

    Programming Instructions Programming the Newly selected Settings ® Programming the RNS Neurostimulator sends all newly selected settings from the programmer to the neurostimulator. The P tab is the only location on the programmer from which ROGRAM ETTINGS new settings can be programmed into the neurostimulator. 1.

  • Page 66: Recommended Initial Ecog Storage Settings

    Programming Instructions triggers may be helpful in evaluating the detection setting parameters. These triggers can be used whenever detection is ENABLED. • triggers initiate ECoG storage when electrical stimulation therapy is ESPONSIVE HERAPY delivered in response to a detected event. Selecting this trigger may be helpful in determining if therapy was delivered appropriately as well as evaluating the result of the therapy delivered.
  • Page 67 Programming Instructions Figure 24: ECoG Storage tab. ® System User Manual...

  • Page 68: Recommended Modifications To Ecog Storage Settings

    Programming Instructions Recommended Modifications to ECoG Storage Settings ® ECoGs stored by the RNS Neurostimulator during the first several days after implantation of the neurostimulator and leads may not be representative of the patient’s typical baseline activity. ECoG storage settings should be reviewed to ensure that the desired activity is being stored. If it appears that ECoGs containing the desired activity are being overwritten by later events, instruct the patient to use the remote monitor and wand to interrogate the neurostimulator immediately after each clinical seizure, or to interrogate several times per day.

  • Page 69: Programming The Newly Selected Ecogs Storage Settings

    Programming Instructions • If ECoG storage needs to be modified, adjust the L , the M trigger PISODE ENGTH AGNET and/or the L ENGTH OF TORED The L (duration) may be adjusted (longer or shorter) to capture the PISODE ENGTH •...

  • Page 70: Setting Up Detection

    Neurostimulator to recognize epileptiform activity as defined by the physician. Although detection sets can be created and modified using either the PDMS or the NeuroPace® Programmer, it is recommended that these activities be carried out on the PDMS, for reasons of convenience.

  • Page 71: Recommended Initial Detection Settings

    Programming Instructions 7. Confirm D is enabled or disabled, as desired. ETECTION Recommended Initial Detection Settings Initially, in order to capture ECoGs containing activity that can be used to configure detection settings specific to the patient, program initial detection settings on the D tab as follows: ETECTION Select *Default* Line Length 75% on Ch 1 &...

  • Page 72: Recommended Modifications To Detection Settings

    (detectors). Three detector types are available; these are the line length, area, and bandpass. The detector type should be selected based on the type of pattern to be detected. These recommended modifications apply whether using the PDMS or the NeuroPace® Programmer to configure detection. Line length detector The line length detector provides detection of power (a type of ECoG activity).
  • Page 73 Programming Instructions Area detector The area detector measures the area between the ECoG and the time axis (see Figure 30). 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 window (typically 1 to 2 minutes).
  • Page 74 Programming Instructions Bandpass detector The bandpass detector provides highly specific and early detection of rhythmic and spiking activity (types of ECoG activity). It acts like a frequency filter and can therefore be used to detect activity within specific frequency bands (e.g. theta, alpha, beta, and gamma). The bandpass detector analyzes the ECoG to determine when a signal is present within a specified bandwidth that meets specified amplitude and duration requirements.
  • Page 75 Programming Instructions Figure 32: Line Length tab. • Configure B detector(s) (Figure 33). ANDPASS Bandpass detectors can improve detection response time because they use shorter detection • windows and do not rely on a long-term trend. Bandpass is very specific to a band of frequencies and an amplitude as programmed by the physician.

  • Page 76: Programming The Newly Selected Detection Settings

    Programming Instructions Figure 33: Bandpass tab. Programming the Newly Selected Detection Settings 1. Select the P tab. ROGRAM ETTINGS 2. Select R to view changes prior to programming. EVIEW HANGES 3. Select the P button. ROGRAM ® System User Manual...

  • Page 77: Setting Up Responsive Therapy

    Programming Instructions ETTING UP 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 78: Enabling, Disabling, Or Changing Responsive Therapy

    Programming Instructions Before programming responsive therapy, at least one detector must be defined in a detection set. (If detection pattern specific therapy is selected, at least one detector must be defined for each pattern.) Detection must be enabled before responsive therapy can be enabled. Enabling, Disabling, or Changing Responsive Therapy 1.

  • Page 79: Recommended Initial Responsive Therapy Settings

    Programming Instructions settings will now be reflected on the T tab or select C to return to the HERAPY ANCEL HANGES tab with the original settings. HERAPY 10. Select R to be ENABLED. ESPONSIVE HERAPY Recommended Initial Responsive Therapy Settings Stimulation may be programmed ON when appropriate detection settings have been established.
  • Page 80 Programming Instructions Figure 36: Therapy testing screen. ® System User Manual...
  • Page 81 Programming Instructions • Suggested initial responsive therapy settings: In general, stimulation should be delivered to the leads and electrodes from which the activity • of interest is observed. Program B 1 for electrodes on one lead. Program B 2 for electrodes on the other •...

  • Page 82: Recommended Modifications To Responsive Therapy Settings

    Programming Instructions Recommended Modifications to Responsive Therapy Settings Based on the clinical response, the physician may choose to modify stimulation. If the physician chooses to modify stimulation, it is recommended that the current amplitude be increased in 0.5 mA increments. It is recommended that stimulation settings be tested using the test stimulation function to ensure that it is well tolerated by the patient and there are no undesired changes in the ECoG such as afterdischarges.

  • Page 83: Reviewing Reports

    Programming Instructions the Adaptive% = 50% and the sensed signal frequency = 20 Hz (50 ms period), the stimulation frequency is delivered at 40 Hz (25 ms p-p interval) If the neurostimulator cannot detect a stable frequency in the ECoG signal, or if the calculated stimulation frequency is not between the user selected minimum and and M maximum frequencies (M...

  • Page 84: Magnet

    Magnet AGNET ® The magnet suppresses RNS System therapy as long as the magnet is held in position over the neurostimulator. Placing or swiping the magnet over the neurostimulator stores the time of placement in the neurostimulator, and can also trigger ECoG storage if the neurostimulator is programmed to do so.

  • Page 85: Patient Follow-Up Activities

    UMMARY 3. Select R tab. EVIEW ® Note: Refer to the NeuroPace Patient Data Management System for historic neurostimulator information. Review stored ECoGs. • Test system integrity by obtaining electrode impedance measurements. • If not already displayed, measure the battery voltage.

  • Page 86: Troubleshooting

    AMAGED RODUCTS Inspect NeuroPace products for any damage or breach in package seal integrity. If packaging appears to be wet, punctured, or damaged, contents in package may no longer be sterile. Product(s) with damaged components and/or packaging should not be used and should be returned to NeuroPace for replacement.
  • Page 87 Troubleshooting View the real-time ECoGs to verify that the signal is sufficient and without noise or • artifacts. Repeat impedance measurements. • Note: If the abnormal impedance is associated with the same electrode label, then the problem may be with the lead. Depth lead - Impedance >...

  • Page 88: Insufficient Charge

    PDMS interrogation report event list show the “Programmed current” is higher than the “Lowest delivered” current (as shown in the example image) contact your NeuroPace Field Clinical Engineer. The NeuroPace Field Clinical Engineer will help you review the lead impedances and neurostimulator configuration settings to determine the cause.

  • Page 89: Poor Or No Communication Between The Rns ® Neurostimulator And The Programmer

    Troubleshooting ® 9. Secure the connector cover onto the RNS Neurostimulator using the torque driver. 10. View the real-time ECoGs to verify that the signal is sufficient and free of noise or artifacts. Isolated artifacts may be the result of electrostatic discharge (ESD) / static electricity shocks to the programmer.

  • Page 90: Programmer Turns Off Or Freezes

    2. Hold the programmer power button down for 5-10 seconds. 3. Release the programmer power button. 4. Press the programmer power button again. If the programmer does not restart, follow the above instructions again. If the programmer still does not respond, contact NeuroPace for further assistance. Low Battery Measurement 1.
  • Page 91 The neurostimulator is now programmed to the state it was in before the reset occurred. • 5. If the reset persistently reoccurs in the absence of any surgical procedures, the neurostimulator may be defective. Contact NeuroPace for further assistance. ® System User Manual...

  • Page 92: Specifications And Characteristics

    Specifications and Characteristics PECIFICATIONS AND HARACTERISTICS ® EUROSTIMULATOR 28 mm IDTH 42 mm (including lead strain relief) 60 mm ENGTH 7.7 mm HICKNESS 8.5 mm (including lead strain relief) 16 g EIGHT 18 g (including connector cover & lead strain relief) 11 cc OLUME Titanium...

  • Page 93: 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 TECHNOLOGY telemetry Clinical setting and home environment NTENDED NVIRONMENT 0 –...

  • Page 94: Implantable Rns ® System Component And Accessory Materials

    Specifications and Characteristics ® MPLANTABLE YSTEM OMPONENT AND CCESSORY ATERIALS Component or Accessory Material Polyaryletheretherketone /Titanium ONNECTOR OVER Silicone ONNECTOR Titanium RANIAL ROSTHESIS Titanium ERRULE Polyaryletheretherketone /Titanium ERRULE LAMP Silicone Silicone TRAIN ELIEF Silicone UTURE LEEVE ® EURO ROGRAMMER 3.3 x 35 x 24 cm (typical) IMENSIONS Commercial materials...

  • Page 95: Electromagnetic Emissions And Immunity

    Specifications and Characteristics LECTROMAGNETIC MISSIONS AND MMUNITY Electromagnetic interference (EMI) is a field of energy generated by equipment found in the home, work, medical, or public environments that is strong enough to interfere with ® neurostimulator function. The RNS System is designed to be immune from common sources of electromagnetic interference.
  • Page 96 Vacuum cleaners and electric brooms. For additional information about devices that generate electromagnetic interference contact NeuroPace. If a patient suspects EMI is disrupting the operation of their neurostimulator advise the patient to move away from the source of the EMI.
  • Page 97 Specifications and Characteristics Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity – for all equipment and systems Immunity test Compliance level Electromagnetic environment – guidance ± 2, 4, 6, 8 kV contact Floors should be wood, concrete or Electrostatic discharge discharge ceramic tile.
  • Page 98 Specifications and Characteristics Table 4. 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 be used no closer to any part of the RNS 3 Vrms System, including cables, than the recommended Conducted RF...
  • Page 99 Specifications and Characteristics Table 5. Recommended separation distances between portable ® and mobile RF communications equipment and the RNS System – a,b,c for equipment that are not life-supporting Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz...

  • Page 100: System Products, Components, Accessories, And Tools

    System Products, Components, Accessories, & Tools YSTEM RODUCTS OMPONENTS CCESSORIES OOLS Note: Manuals and other literature are not listed below. ® ® NeuroPace Neurostimulator Kit Model RNS-300M-K Item Model Number ® ® NeuroPace Neurostimulator RNS-300M Connector Cover CC-01 Ferrule F-01...
  • Page 101 System Products, Components, Accessories, & Tools ® NeuroPace Lead Accessory Kit Model LA-02-K Item Model Number Lead Cap (2) LC-01 Suture Sleeves (4) SS-01 Stop Gauge SG-01 Tunneling Tool TT-01 Tunneling Tool Tip TTT-01 Tunneling Tool Straw TTS-01 ® NeuroPace...
  • Page 102 System Products, Components, Accessories, & Tools ® NeuroPace Remote Monitor Kit Model DTR-300-E-K Item Model Number ® NeuroPace Remote Monitor DTR-300-E Ethernet Cable (Network Cable) Carrying Case PC-01 Used With Wand W-02 Craniectomy Template Kit Cranial Prosthesis Kit Model CT-01-K...

  • Page 103: Glossary

    Glossary LOSSARY Adaptive%. Adaptive% is an advanced responsive therapy setting. The Adaptive% specifies a ratio of the pulse-to-pulse interval of the stimulation to the sensed signal period. 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.
  • Page 104 Glossary Burst 1. The first burst of stimulation delivered within an individual responsive therapy. This burst may be delivered asynchronously or synchronously. Burst 2. The second burst of stimulation delivered within an individual responsive therapy. This burst may be programmed ON or OFF for each therapy and will always be delivered asynchronously following Burst 1 of the therapy if programmed ON.
  • Page 105 Glossary ECoG storage trigger. The type of neurostimulator activity selected by the user to result in the storage of an ECoG record if the activity occurs. Elective replacement indicator (ERI). The ERI indicator is displayed on the programmer to notify the user that the neurostimulator is approximately three months prior to end-of-service (EOS).
  • Page 106 ECoG triggering event. Programmer. The programmer is a laptop personal computer that runs software developed by NeuroPace to communicate with the neurostimulator, to download selected settings into the neurostimulator, and to upload information from the neurostimulator. The programmer communicates with the neurostimulator via the wand.
  • Page 107 ECoGs will be stored, and no diagnostics will be stored (however events prior to reset will be saved). If a neurostimulator reset occurs, the user should note the cause of the reset and contact NeuroPace. Responsive therapy. Electrical stimulation output to cortical tissue by the neurostimulator in response to pattern A or pattern B detection.
  • Page 108 Glossary Therapy limit per day. Responsive therapy delivery will be DISABLED for the remainder of the day after the programmed number of responsive therapies has been delivered. Therapy sequence. Responsive therapy is delivered as a therapy sequence of up to 5 individually configured sequential therapies (electrical stimulation) in response to each detected episode.

  • Page 109: Index

    Connector Cover, 21, 102 Elective Replacement Indication (ERI), 27, 89, Connector Plug, 21, 45, 49, 51, 102 Connector port, 102 Electroconvulsive Therapy (ECT), Contacting NeuroPace, 5 Contraindication, 8 Contraindications, 8 Electrolysis, 13 Cortical Strip Lead, 102 ElectroMagnetic Interference (EMI), 10...
  • Page 110 Modifying Settings, 31, 65, 69, 79 Product Compatibility, 9 Montage, 32, 58, 61, 104 Product handling, 25 Product registration, 27 Product storage, 25 NeuroPace components—warning, 12 Programmer, 18, 104 Neurostimulator, 105 Components and Accessories, 24 Description, 23 Assigning Lead Labels, 58, 60...
  • Page 111 Index Neurostimlator / Leads Connection, 43 Neurostimulator / Ferrule Implant, 39 Qualification, Physician & Center, 8 Pre-Implant, 32 Replacing Leads, 50 ® Replacing RNS System, 47 Tunneling, 43, 44 Suture sleeve, 105 Radiation, 13 Suture Sleeve, 23 Radio Frequency Identification (RFID) Symbols, Glossary, 3 Interference, 11 Synchronization, 57...
  • Page 112 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 User Manual...

This manual is also suitable for:

Neuropace dl-330-3.5Neuropace dl-330-10Neuropace dl-344-3.5Rns-300mNeuropace dl-344-10Neuropace cl-315-10 ... Show all

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