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Neuropace 5106 Manual

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THE RNS® SYSTEM
Remote Monitor
Manual
Model 5106
© 2023 NeuroPace, Inc.
DN 1019078 Rev. 6
Rev. Date: 2023-08
This manual includes information for the use of the NeuroPace® Remote
Monitor and is a supplement to your RNS® System Patient manual. 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 to your doctor.
NeuroPace® Patient Materials

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  • Page 1 THE RNS® SYSTEM Remote Monitor Manual Model 5106 This manual includes information for the use of the NeuroPace® Remote © 2023 NeuroPace, Inc. Monitor and is a supplement to your RNS® System Patient manual. This DN 1019078 Rev. 6 manual is not meant to take the place of advice from your doctor. For a Rev.
  • Page 2 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 Remote Monitor Manual Model 5106...

  • Page 3: Table Of Contents

    Turn on the Remote Monitor...19 Problems Uploading Data...46 20 Basics 58 If You Need Help Tablet Touchscreen and Buttons...21 Home Screen...21 Connect to Wi-Fi...22 Wi-Fi Button on the Home Screen...24 Confirm Remote Monitor Setup...24 Turn Off The Remote Monitor...25 Remote Monitor Manual Model 5106...

  • 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 • Neurostimulator model RNS-300M FCC ID: your authority to operate them.

  • Page 5: Symbols

    State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov. Note: Images in this manual are representative and may vary in detail from what a particular user experiences. Remote Monitor Manual Model 5106...

  • Page 6: Safety Information

    This is especially important if the scan area procedure. includes the implant site. • The neurostimulator should be turned back on after the procedure. Remote Monitor Manual Model 5106...
  • Page 7 System has not been studied in pregnant cloth, dampened with water and wrung out. women. Make sure to disconnect the tablet from the electrical outlet before cleaning. Remote Monitor Manual Model 5106...
  • Page 8 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 9: Cautions

    You can also call the manufacturer of the item and ask them. Most headsets and earphones available in stores do not interfere with stimulation, but not all have been tested. Remote Monitor Manual Model 5106...
  • Page 10 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 11 (32°F - 95°F). The wand or tablet may not operate properly at temperatures below 32°F or above 95°F. These devices may also become warm during normal operation. DO NOT use them when the room temperature is above 95°F to avoid discomfort. Remote Monitor Manual Model 5106...

  • Page 12: Cybersecurity, Device Security, And Patient Information

    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 13 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 35 more detail. SECURITY EVENTS The Windows security software logs security events and issues but security notifications are not displayed during normal operation.

  • Page 14: About

    About INDICaTIoNS FoR USE...13 PURPoSE oF YoUR REMoTE MoNIToR...13 Remote Monitor Manual Model 5106...

  • Page 15: Indications For Use

    INDICaTIoNS FoR USE PURPoSE oF YoUR REMoTE MoNIToR Refer to your RNS® System Patient The NeuroPace® Remote Monitor (5106) is Manual for the indications for use. For a designed for use with the RNS® Neurostimulator complete discussion of indications for use, (models RNS-300M and RNS-320).

  • Page 16: Parts

    Parts CaRRYING CaSE...15 THE REMoTE MoNIToR SoFTWaRE oN TaBLET CoMPUTER...15 WaND...15 PoWER CoRD...15 Remote Monitor Manual Model 5106...

  • Page 17: Carrying Case

    The remote monitor software program is already installed on the tablet computer. It stores data collected by the wand, and then sends it to the secure NeuroPace database (PDMS). The tablet computer you receive may not be the same model shown here. The location of the connections may also differ from the model shown here.

  • Page 18: Setup

    Setup FIND a GooD PLaCE To SETUP...17 CHaRGE THE REMoTE MoNIToR...17 TURN oN THE REMoTE MoNIToR...19 Remote Monitor Manual Model 5106...

  • Page 19: Find A Good Place To Setup

    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 20 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 connections connected, the battery is charged and the power cord is may also differ from the...

  • Page 21: Turn On The Remote Monitor

    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 22: Basics

    Basics TaBLET ToUCHSCREEN aND BUTToNS...21 HoME SCREEN...21 CoNNECT To WI-FI...22 WI-FI BUTToN oN THE HoME SCREEN...24 CoNFIRM REMoTE MoNIToR SETUP...24 TURN oFF THE REMoTE MoNIToR...25 Remote Monitor Manual Model 5106...

  • Page 23: Tablet Touchscreen And Buttons

    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 24: Connect To Wi-Fi

    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 25 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 26: Wi-Fi Button On The Home Screen

    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 27: Turn Off The Remote Monitor

    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 28: Get Data

    Get Data Remote Monitor Manual Model 5106...
  • Page 29 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 32 Electromagnetic Emissions and Immunity on page 48 for more information.
  • Page 30 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 31 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 32: Wand

    Wand WaND SIGNaL BaSICS...31 UNDERSTaNDING SIGNaL LEVEL aND QUaLITY...32 WaND Too FaR aWaY oR WaND DISCoNNECTED...32 Remote Monitor Manual Model 5106...

  • Page 33: Wand Signal Basics

    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 34: Understanding Signal Level And Quality

    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 35 If you get another type of error message, follow the instructions on the screen and then try again. Data Collection Problems on page 45 for more information. If you still need assistance, contact NeuroPace Customer Support.

  • Page 36: Update Center

    Update Center UPDaTE TYPES...35 UPDaTE oPTIoNS...35 UPDaTE WaITING...36 UPDaTE PRoCESS aND PoWER REQUIREMENTS...37 Remote Monitor Manual Model 5106...

  • Page 37: Update Types

    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 38: Update Waiting

    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 39: Update Process And Power Requirements

    Button will begin automatically. 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.

  • Page 40: Travel

    Travel aIRPoRT SECURITY...39 TRaVELING...39 Remote Monitor Manual Model 5106...

  • Page 41: Airport Security

    Talk with your doctor in advance to find out computer when going through airport security. what you should do if you are unable to bring your remote monitor with you, because you will not be able to transfer your neurostimulator data as directed. Remote Monitor Manual Model 5106...

  • Page 42: Care And Maintenance

    Care and Maintenance CaRE aND MaINTENaNCE...41 RETURN / DISPoSaL oF TaBLET CoMPUTER aND WaND...41 Remote Monitor Manual Model 5106...

  • Page 43: Care And Maintenance

    The tablet computer and wand should be serviceable by patients. returned to your doctor or NeuroPace if you are no longer using them. They contain electrical • To remove dirt or dust from the wand or...

  • Page 44: Troubleshooting

    Troubleshooting REMoTE MoNIToR PRoBLEMS...43 WaND PRoBLEMS...44 DaTa CoLLECTIoN PRoBLEMS...45 PRoBLEMS UPLoaDING DaTa...46 Remote Monitor Manual Model 5106...

  • Page 45: Remote Monitor Problems

    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 46: Wand Problems

    If this does not solve the problem, try moving the remote monitor to another location away from other electronic devices, and then try again to get data and observe the wand signal. • If your wand signal continues to be a problem, contact NeuroPace Customer Support for assistance.

  • Page 47: Data Collection Problems

    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 48: Problems Uploading Data

    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 49 • 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 50 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 51 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 52 Televisions, aM/FM radios, stereos, personal music players 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 the source of the EMI.
  • Page 53 Limits per Clause 5 flicker emissions purposes. of the Standard (IEC 61000-3-3) Tablet (model 5000), Remote Monitor (models 5100, 5106) with Wand (model W-02) tested for harmonic emissions and flicker. Other products excluded from harmonic emissions and flicker testing.
  • Page 54 DTR-300-E, 5106). Immunity to voltage dips with compliance to 0% UT 1 cycle for Tablet (model 5000), Remote Monitor (models 5100, 5106) and Wand (model W-02) and to 40% UT 5 cycle for Programmer (model PGM-300) and Remote Monitor (model DTR-300-E).
  • Page 55 5 Radiated immunity of the Programmer (model PGM-300), Remote Monitor (model DTR-300-E) compliant to 3 V/m up to 2.5 GHz. Tablet (model 5000), Remote Monitor (models 5100, 5106) and Wand (model W-02) compliant to 10 V/m to 2.7 GHz and spot frequencies with pulse modulation. Spot frequencies tested are 385 MHz, 450 MHz, 710 MHz, 745 MHz, 780 MHz, 810 MHz, 870 MHz, 930 MHz, 1.720 GHz, 1.845...
  • Page 56 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 57 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 58 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 59 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 Wireless Technology Type coil telemetry Intended Use Environment Clinical setting and home environment operating Range 0 –...

  • Page 60: If You Need Help

    If You Need Help Remote Monitor Manual Model 5106...
  • Page 61 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 62 THE RNS® SYSTEM Remote Monitor Manual 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. 455 N. Bernardo Ave. Mountain View, CA 94043 NeuroPace Customer Support 866-726-3876 www.NeuroPace.com...

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