Neuropace RNS-300M Patient Manual

Neurostimulator and the remote monitor model 5106

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RNS

Patient Manual

For the RNS® Neurostimulator Model RNS-300M and

Model RNS-320 and the Remote Monitor Model 5106

Read this manual before

use. This manual is

not meant to take the

place of advice from

your doctor. For a

complete discussion

of indications for use,

contraindications,

warnings, cautions, and

potential side effects

talk with your doctor.

DN 1022549 Rev. 1

Date: 2025-04

System

NeuroPace® Patient Materials

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Summary of Contents for Neuropace RNS-300M

Page 1 NeuroPace® Patient Materials System ® Patient Manual For the RNS® Neurostimulator Model RNS-300M and Model RNS-320 and the Remote Monitor Model 5106 Read this manual before use. This manual is not meant to take the place of advice from your doctor. For a...
Page 2 Ongoing Treatment and Monitoring...20 4 Safety Information 22 Parts Warnings…6 RNS® System Parts...23 Cautions…9 Using the Magnet…24 Cybersecurity, Device Security, and Parts of the NeuroPace® Remote Patient Information…12 Monitor...25 14 About 26 Setup Indications for Use...15 Find a Good Place to Setup...27 Contraindications...15 Charge the Remote Monitor...27...
Page 3 36 Get Data 52 Troubleshooting Remote Monitor Problems...53 40 Wand Signal Wand Problems...54 Wand Signal Basics...41 Data Collection Problems...55 Understanding Signal Level and Problems Uploading Data...56 Quality...42 66 Clinical Studies:Risks and Wand Too Far Away or Wand Disconnected...42 Benefits Risks...67 44 Update Center Benefits...73 Update Types...45...
Page 4 FCC Information The following is communications regulation Important: information on the neurostimulator models Changes or modifications to these components RNS-300M and RNS-320, and wand model not expressly approved by NeuroPace, Inc. W-02. could void the FCC Certification, and negate •...
Page 5 Symbols SYMBoLS Explanation of symbols on product or package labeling Symbol explanation Symbol explanation Temperature limits Caution during use Temperature limits MRI Unsafe during storage or transport Storage MR Conditional Manufacturer Ethernet Connection Prescription Only (Network Connection) Serial Number Type BF applied part 5 V, 0.5 A Direct current (DC) 5 V Class II electrical...
Page 6 (4.7%). There are also the initial implant surgery refer to Implant risks of infection and bleeding with surgery Surgery on page 12. The model RNS-300M to replace or remove the neurostimulator and neurostimulator should work for about leads.
Page 7 So it is important that you collect data from the neurostimulator and send data to the PDMS database as directed by your doctor. NeuroPace recommends you collect data from Patient Manual...
Page 8 In addition, Computerized Tomography (CT or RNS-300M implanted. The RNS Neurostimulator CAT) scans should be performed only under the model RNS-300M is MR Unsafe. Having an MRI following conditions: scan with an RNS Neurostimulator model RNS-300M implanted may result in serious •...
Page 9 • Defibrillation therapy from an implanted WarnInG: rnS® System Failure defibrillator may damage the RNS® System As with any electronic device, the RNS® System • The electrical pulses from the RNS® System may malfunction (not work). Potential causes may interact with the sensing operation include battery malfunctions, an electrical from a cardiac device and could result in an short, open circuits, lead fractures, lead...
Page 10 Use of accessories, transducers, and cables avoided because it could result in improper other than those provided by NeuroPace could operation. If such use is necessary, the result in increased electromagnetic emissions NeuroPace® equipment and other equipment...
Page 11 Cautions WarnInG: Wand Placement DO NOT use (position) the wand over any other medical device. This includes other implanted Caution: Medical Procedures and Dental Work devices such as a pacemaker or defibrillator, as Before all medical procedures tell the person well as devices that are used outside the body, administering the procedure that you have the such as a CPAP machine.
Page 12 When your neurostimulator battery is low, the remote monitor will show the following message on the Home screen: "Your neurostimulator battery has reached its replacement window. Please contact your physician." NeuroPace recommends you act on this message and contact your physician about replacing your neurostimulator. Caution: neurostimulator Longevity...
Page 13 You may damage the parts if you do not monitor sends data automatically to the disconnect them before moving them. PDMS database. NeuroPace recommends you collect data from the neurostimulator at least once a day and maintain a Wi-Fi connection...
Page 14 Cybersecurity, Device Security, and Patient Information The following diagram illustrates the NeuroPace® Remote Monitor network architecture in the home environment. The NeuroPace® Remote Monitor uses a short- • The remote monitor deletes a patient’s range wireless link between the wand and...
Page 15 NeuroPace issues software updates periodically to help secure the RNS System, including the remote monitor. Software security updates should be installed as soon as possible. See the NeuroPace Update Center on page 45 more detail. SeCUrItY eVentS The Windows security software logs security events and issues but security notifications are not displayed during normal operation.
Page 16 About InDICatIonS For USe...15 ContraInDICatIonS...15 ePILePSY anD ItS treatMent...15 treatMent WItH tHe rnS® SYSteM...16 DeSCrIPtIon oF tHe rnS® SYSteM...16 Patient Manual...
Page 17 Are unable, or do not have the necessary assistance, to properly operate the Epilepsy is usually treated first with antiepileptic NeuroPace® Remote Monitor or magnet. drugs. These drugs help to prevent seizures. If a person’s epilepsy cannot be brought under...
Page 18 The RNS® System treatMent WItH tHe rnS® SYSteM The RNS® System is designed as a treatment for medical refractory partial epilepsy with partial onset seizures, in which seizures begin neurostimulator in a focus in the brain and then may spread to involve other parts or even the entire brain.
Page 19 Magnet ID card System) and your doctor can access your data. For the model RNS-300M, this is usually after Your doctor will review the data and use the 2.6 to 4.3 years with typical use; for medium results to adjust the neurostimulator settings stimulation and detection settings the battery during future office visits.
Page 20 What to Expect with the ® System IMPLant SUrGerY...19 BeFore YoUr SUrGerY...19 YoUr IMPLant SUrGerY...19 PoSt-SUrGerY reCoVerY...20 onGoInG treatMent anD MonItorInG...20 Patient Manual...
Page 21 What to Expect with the RNS® System Implant Surgery If you have more than two leads put in, only two leads will be connected to the neurostimulator. The ones that are not connected to the BeFore YoUr SUrGerY neurostimulator are not active and cannot deliver responsive stimulation.
Page 22 You will use Your incision areas will be checked to make sure the NeuroPace® Remote Monitor and wand to they are healing properly. collect data from the neurostimulator and send...
Page 23 Replacement surgery will be less battery power is low. The model RNS-300M complex and should take less time than when neurostimulator should last 2.6 to 4.3 years the neurostimulator was first implanted.
Page 24 Parts rnS® SYSteM PartS...23 USInG tHe MaGnet…24 PartS oF tHe neUroPaCe® reMote MonItor...25 Patient Manual...
Page 25 RNS® System and stimulation through these wires. makes them aware of procedures that may be harmful (such as an MRI), your physician’s name and phone number, and which NeuroPace products have been implanted. Patient Manual...
Page 26 Using The Magnet tHe MaGnet HaS tWo USeS Use 1: It instructs the neurostimulator to make a recording of your brain activity when you choose. To record an event, swipe the magnet over the neurostimulator while counting to 3. For example, swipe the magnet while you say “counting 1, counting 2, counting 3.”...
Page 27 Parts of the NeuroPace® Remote Monitor Make sure you have all the parts described below. Contact NeuroPace Customer Support at 866-726-3876 if any parts are missing. The tablet computer you receive may not be the same model shown here. The...
Page 28 Setup FInD a GooD PLaCe to SetUP...27 CHarGe tHe reMote MonItor...27 tUrn on tHe reMote MonItor...29 Patient Manual...
Page 29 The remote monitor is intended to be used by the patient at home. Follow the steps below to set up the remote monitor for use. Contact NeuroPace Customer Support if you need assistance to set it up or to report any unexpected events.
Page 30 Unplug before use. note: Before using the wand, make sure the tablet is The tablet computer you sufficiently charged and unplug it from the electrical outlet. receive may not be the same model shown here. The The remote monitor is ready for use when the wand is location of the buttons and connected, the battery is charged and the power cord is connections may also differ...
Page 31 When you power on the tablet, the remote monitor first checks for any software updates to install. If the remote monitor has a software update ready to install, the NeuroPace Update Center appears before you get to the Home screen. NeuroPace recommends you install all software updates right away, and it usually takes only a matter of minutes to install.
Page 32 Basics taBLet toUCHSCreen anD BUttonS...31 HoMe SCreen...31 ConneCt to WI-FI...32 WI-FI BUtton on tHe HoMe SCreen...34 ConFIrM reMote MonItor SetUP...34 tUrn oFF tHe reMote MonItor...35 Patient Manual...
Page 33 Remote Monitor Basics The main components of the remote monitor taBLet toUCHSCreen anD BUttonS are the tablet computer with the special The remote monitor tablet is a touchscreen software installed and the wand. You will device; it is operated by touching elements use the wand to collect data from the on screen, such as software buttons.
Page 34 ConneCt to WI-FI To communicate with the NeuroPace database (PDMS), connect the remote monitor to a Wi-Fi network following the instructions below. Touch the Wi-Fi button at lower left to view and select available wireless networks. Touch to select the...
Page 35 Note the following additional information and options about wireless network connections: • The operating system remembers the passwords you enter and connects automatically to networks that you connected to before, if Wi-Fi is on. (There is an on-off button at upper right.
Page 36 WI-FI BUtton on tHe HoMe SCreen All gray bars mean the tablet Black bars mean Wi-Fi is “OFF” with gray bars means is not connected to Wi-Fi, connected to a wireless Wi-Fi is off. Wi-Fi is on by but Wi-Fi is on. This is how it network.
Page 37 tUrn oFF tHe reMote MonItor When you are finished using the remote monitor, be sure to turn it off. This will help conserve tablet battery power and electricity when not in use. The remote monitor tablet does not automatically go into “sleep” mode if you forget to turn it off. note: Use the Power button on screen to turn off the tablet.
Page 38 Get Data Patient Manual...
Page 39 Get Data from Your Neurostimulator When you get data from your neurostimulator, observe the wand signal to confirm proper placement of the wand and that there are no large sources of EMI that may affect data collection. Refer to Understanding Signal Level and Quality on page 42 Electromagnetic Emissions and Immunity on page 58 for more information.
Page 40 While holding the wand in place, touch Get Data from your neurostimulator on the Home screen. The screen reports “Communicating with Neurostimulator” and then “Getting data from the Neurostimulator.” If it says anything else, read and follow the on-screen instructions to complete data gathering.
Page 41 Normally it takes less than a minute to upload data, but it depends on the speed of your Wi-Fi connection. It is not necessary to monitor upload. If the device is not connected to Wi-Fi, the data will be uploaded automatically the next time it is connected.
Page 42 Wand Signal WanD SIGnaL BaSICS...41 UnDerStanDInG SIGnaL LeVeL anD QUaLItY...42 WanD too Far aWaY or WanD DISConneCteD...42 Patient Manual...
Page 43 Wand Signal Basics The wand is used to collect data from the To check the signal level and quality, see neurostimulator and store it in the tablet. Data the instructions to Get Data from Your are collected using Radio Frequency (RF) Neurostimulator on page communication.
Page 44 UnDerStanDInG SIGnaL LeVeL anD QUaLItY While gathering data, the screen shows signal level and quality. The signal Level is the current You can observe the level and signal strength between the wand and the quality of the wand signal neurostimulator. The Level will vary as you move the wand closer or further from the neurostimulator.
Page 45 If you get another type of error message, follow the instructions on the screen and then try again. Data Collection Problems on page 55 for more information. If you still need assistance, contact NeuroPace Customer Support. Patient Manual...
Page 46 Update Center UPDate tYPeS...45 UPDate oPtIonS...45 UPDate WaItInG...46 UPDate ProCeSS anD PoWer reQUIreMentS...47 Patient Manual...
Page 47 NeuroPace Update Center The remote monitor checks for software updates when you power on the tablet. The neuroPace Update Center opens if any updates are available for installation. As described below, the Update Center identifies the update type(s) and allows you to update now or on shutdown.
Page 48 Home screen: “An important software update is waiting. Press the power button to install it.” NeuroPace recommends you follow the instructions to install it: Press the power button at lower right on the Home screen.
Page 49 If the software update has not started, you can select the option at lower right to Defer Update until the next time you restart the tablet, at which time the neuroPace Update Center will appear again. Patient Manual...
Page 50 Travel aIrPort SeCUrItY...49 traVeLInG For an extenDeD PerIoD oF tIMe WItHIn tHe U.S..49 traVeLInG oUtSIDe tHe U.S..49 I have a medical implant. Patient Manual...
Page 51 Traveling with the RNS® System traVeLInG For an extenDeD PerIoD oF tIMe WItHIn tHe U.S. Carrying If you are unable to bring your remote monitor Case with you, you will not be able to transfer your neurostimulator data as directed. Talk with your doctor in advance to find out what you should do in these situations.
Page 52 Care and Maintenance Care anD MaIntenanCe...51 retUrn / DISPoSaL oF taBLet CoMPUter anD WanD...51 Patient Manual...
Page 53 WanD The tablet computer and wand should be The remote monitor and wand do not returned to your doctor or NeuroPace if you are require any special maintenance and are not no longer using them. They contain electrical serviceable by patients.
Page 54 Troubleshooting reMote MonItor ProBLeMS...53 WanD ProBLeMS...54 Data CoLLeCtIon ProBLeMS...55 ProBLeMS UPLoaDInG Data...56 Patient Manual...
Page 55 Possible The tablet battery can no longer hold a charge. Cause What to Contact NeuroPace Customer Support to arrange for a replacement remote monitor. reMote MonItor ProBLeMS tablet Does not respond Problem The tablet does not respond to touches. Possible There may be a problem with the tablet operating system.
Page 56 • If your wand signal continues to be a problem, contact NeuroPace Customer Support for assistance. Patient Manual...
Page 57 Data Collection Problems Data CoLLeCtIon ProBLeMS Problems Getting Data One of the following messages appears on the screen: • “Unable to communicate with the neurostimulator. Reposition the wand over the Neurostimulator.” Problem • “Telemetry has been lost. The Wand may have been unexpectedly or temporarily disconnected.
Page 58 Problems Uploading Data Problems Uploading Data not Connected to Wi-Fi or Wi-Fi turned off The following message appears on the Home screen: Problem • Your remote monitor is not connected to Wi-Fi. Possible • The Wi-Fi on your remote monitor is turned off. Causes •...
Page 59 • There is an unknown problem • The Wi-Fi network requires you to enter connecting to the NeuroPace information in a web browser to connect PDMS database through the to the Internet, as at some hotels and Internet, even though your other businesses.
Page 60 Electromagnetic Emissions and Immunity 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 61 HoSPItaL or MeDICaL enVIronMentS For your convenience, the following tables list potential EMI sources alphabetically using these headings: • Should not affect operation: Commonly used items that should not affect the operation of the neurostimulator. • avoid or exercise caution: You should avoid or exercise caution when in the presence of potential sources of EMI that may affect the operation of the neurostimulator system.
Page 62 Vacuum cleaners and electric brooms For additional information about devices that generate electromagnetic interference contact NeuroPace. If you suspect EMI is disrupting the operation of your neurostimulator move away from Patient Manual the source of the EMI.
Page 63 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided. This declaration applies for the following devices: • RNS® Neurostimulator, models RNS-300M and RNS-320. • RNS® Tablet, model 5000. •...
Page 64 taBLe 2: GUIDanCe anD ManUFaCtUrer’S DeCLaratIon – eLeCtroMaGnetIC IMMUnItY – For aLL eQUIPMent anD SYSteMS electromagnetic Immunity test Compliance environment – guidance Floors should be wood, ± 8 kV contact discharge¹ concrete or ceramic tile. If floors electrostatic discharge ± 2, 4, 8, 15 kV air are covered with synthetic (eSD) (IeC 61000-4-2) material, the relative humidity...
Page 65 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 3 Vrms 150 KHz to 80 MHz Conducted rF 6 Vrms ISM bands (IeC 61000-4-6) 6 Vrms Amateur Portable and mobile RF communications equipment...
Page 66 Conducted immunity of the Tablet (model 5000) and Remote Monitor (models 5100, 5106 compliant to 6 Vrms in the ISM bands. Wand (model W-02) is compliant to 6 Vrms in the ISM and Amateur bands. 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.
Page 67 taBLe 4: reCoMMenDeD SeParatIon DIStanCeS BetWeen PortaBLe anD MoBILe rF CoMMUnICatIonS eQUIPMent anD tHe rnS® SYSteM 1, 2, 3 Separation distance according to frequency of transmitter (m) rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz output power of d = 1.17√P d = 1.17√P...
Page 68 Clinical Studies: Risks and Benefits rISKS...67 BeneFItS...73 Patient Manual...
Page 69 Risks note: There are risks and benefits associated with all medical devices and treatments. Talk to your doctor about the risks and benefits of SaFetY reSULtS the RNS® System and whether it is appropriate for you. Your doctor can also answer questions You can ask your doctor to discuss adverse regarding the information in this manual.
Page 70 aDVerSe eVentS DUrInG tHe CoMParISon PerIoD (PIVotaL StUDY) Serious adverse events were compared for the During this same time period, non-serious patients who were receiving stimulation during adverse events occurred in 70 Treatment Group the Comparison Period (the Treatment Group) patients (72.9%) and 62 Control Group patients and for those who were not (the Control Group).
Page 71 taBLe 2: PIVotaL StUDY - SerIoUS anD non-SerIoUS aDVerSe eVentS In ≥2.5% oF PatIentS In eItHer GroUP DUrInG tHe CoMParISon PerIoD treatment (n=96) Control (n=93) adverse event % (#) patients with % (#) patients events with events Nasopharyngitis (sore throat and runny nose) 6.3% (6) 8.6% (8) Headache...
Page 72 CoMBIneD rnS® SYSteM StUDIeS SerIoUS aDVerSe eVentS oF PartICULar reLeVanCe (CoMBIneD StUDIeS) For the combined studies, all of the adverse events that occurred to any patient at any time Serious adverse events of particular relevance were collected whether the doctor thought in persons with epilepsy and in persons with an they were related to the RNS®...
Page 73 • Suicide (2), depression with suicidal new symptoms as part of a complex partial thoughts (6), suicide attempt (6), suicidal seizure (33 patients, 12.9%) and new symptoms ideation (thoughts)(2) and suicidal behavior as part of a simple partial sensory seizure (29 (threats or gestures) (2).
Page 74 WItHDraWaLS anD DISContInUatIonS Serious adverse events which occurred after the neurostimulator was removed included: As of May 12, 2011, in the combined RNS® 1 patient had a replacement of the bone at System studies, 43 of 256 (16.8%) patients the implant site; 1 patient had worsening of stopped participating in the RNS®...
Page 75 Benefits The RNS® System has been shown to reduce the frequency of disabling seizures in adults with partial onset seizures that have not been controlled with antiepileptic medications. In the comparative study, seizure frequency was measured for 3 months in both the Treatment Group (received stimulation) and the Control Group (did not receive stimulation).
Page 76 Specifications Characteristics Patient Manual...
Page 77 Specifications and Characteristics taBLe 5: WanD Dimensions (Length x Width x Depth) 7” x 3.5” x 1.3” (18 cm x 9 cm x 3 cm) Weight 0.4 pounds (181 g) Power Source USB port of the remote monitor tablet Temperature: 32 to 95 °F (0 to 35 °C) operating Conditions Humidity: 15 to 90%, non-condensing Atmospheric pressure: 700 to 1060 hPa...
Page 78 taBLe 6: reMote MonItor taBLet CoMPUter* 245 mm × 175 mm × 8.3 mm (9.65” × 6.9” × Dimensions (Height x Width x Depth) 0.33”) Weight 544 g (1.2 lbs) 100 – 240 VAC, 50/60 Hz, 0.6A or internal Power Source rechargeable battery USB Power Supply 5V, 500 mA...
Page 79 taBLe 7: rnS® SYSteM WIreLeSS teLeMetrY Transfer data between the neurostimulator Wireless Function and the remote monitor and wand Short range, low power inductive coil to coil Wireless technology type telemetry Intended Use environment Clinical setting and home environment operating range 0 –...
Page 80 If You Need Help Patient Manual...
Page 81 PDMS database as your doctor has directed. • You need help with the set up or use of the remote Contact monitor or wand. NeuroPace • You need to replace any part of the remote monitor, wand, or magnet. Customer Support •...
Page 82 SYSteM System ® Patient Manual For the RNS® Neurostimulator Model RNS-300M and Model RNS-320 and the Remote Monitor Model 5106 For additional patient resources, go to: www.neuropace.com/patients/ current-rns-system-patients or simply scan the QR code You can also call us at 866-726-3876 NeuroPace, Inc.

This manual is also suitable for:

Rns-320