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Axonics 2501 Manual

Clinician programmer
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Sacral Neuromodulation System
Clinician Programmer Manual
Model 2501 Clinician Programmer
!USA Rx ONLY

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  • Page 1 Sacral Neuromodulation System Clinician Programmer Manual Model 2501 Clinician Programmer !USA Rx ONLY...
  • Page 2 Axonics®, Axonics Sacral Neuromodulation System® and r-SNM® are trademarks of Axonics, Inc., registered or pending registration in the U.S. and other countries. Refer to the appropriate clinician manuals for additional information on the Axonics SNM System, including contraindications, warnings, precautions, adverse events, individualization of treatment,...

  • Page 3: Table Of Contents

    Table of Contents Introduction ........1 Programming the External Trial Stimulator ..32 Indications, Warnings, and Precautions Setting Up a New Trial Stimulator Purpose of the trial system...
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  • Page 5: Introduction

    Introduction This manual provides information about the Model 2501 Axonics Sacral Neuromodulation (SNM) System Clinician Programmer (CP). The CP can be used during implantation and programming of the following Axonics SNM System components: Axonics Model 1601 Trial Stimulator • Axonics Model 1901 PNE Lead •...

  • Page 6: Indications, Warnings, And Precautions

    Refer to Information for Prescribers booklet for warnings, precautions, adverse events, patient selection and clinical • summary. Refer to MRI Physician Guidelines for MRI specific conditions and contraindications. • Purpose of the trial system The Axonics SNM Trial System is used for a test period to evaluate if a subject should be treated with the Axonics SNM System.

  • Page 7: Precautions

    Precautions Unintended Use – The CP is intended for use during implantation and programming of the Axonics SNM System. It should only be used with manufacturer provided accessories. Do not use the CP for stimulation or other purposes not described in this manual. Unintended use can result in user or patient injury. Accidental Electrode Contact – Avoid accidental contact between connected but unapplied electrodes and other...

  • Page 8: Device Specifications

    Power source: Lithium-ion battery (rechargeable) Usage environment External power source: Powerbox EMX30 The following lists the appropriate temperature, humidity, and pressure condition for use of the Axonics Input Power: 100 – 240 VAC, 47 – 63 Hz, 0.3 - 0.6 A Output Power: 15 V, 2 A Temperature: 5 °C to 35 °C •...

  • Page 9: Maintenance

    Cleaning: The CP can be wiped with a cloth lightly moistened with water. No other cleaning agents should be used. • Replacement: If the CP is lost or not working, contact Axonics. • Disposal: Do not incinerate the CP as the battery may explode. If the CP is no longer needed, contact Axonics to • return the device. Wireless Communication Radiofrequency telemetry •...
  • Page 10 Note: Changes and modifications to the Clinician Programmer are such stations, including interference that may cause not authorized by Axonics and could void FCC and IC certification undesired operation. This transmitter shall be used only and negate the user’s authority to use the product. in accordance with the FCC Rules governing the Medical Note: The USB port on Clinician Programmer is used for the purpose Device Radio Communication Service.

  • Page 11: Start Up And General Functions

    Start Up and General Functions This section describes the process of starting up the Clinician Programmer (CP) and provides instructions on several key CP functions that are encountered in multiple screens when using the CP. The following sections include: Getting Started Summary of CP Buttons and Functions • Turning the CP on and off •...

  • Page 12: Summary Of Cp Buttons And Functions

    7 Stimulation Ground 8 Foramen Needle or PNE Lead Test Stimulation 9 Power Input USB port The purposes and uses of these buttons and connections are described throughout this manual Note: EMG functionality is not available in this model of the Axonics Clinician Programmer. Note: The USB port is disabled in all screens except, Reports List Screen (see section Reports).

  • Page 13: Turning The Clinician Programmer On And Off

    Turning the Clinician Programmer On and Off Turning On the CP Press and hold the power button ( 1 ) to turn on the CP. • The CP screen will show the Axonics logo as the CP starts up. • The CP will proceed to the password protected Log-In screen. • Turning Off the CP From any CP screen, press and hold the power button •...

  • Page 14: Logging-In To The Clinician Programmer

    Logging-in to the Clinician Programmer When the CP is turned on, it will A short list of names will appear A key pad will appear when a user • • • start-up at the Log-In screen. when the down arrow is pressed. name is selected. By default, the “ADMIN” user Press a user name to select it to Enter the 4-digit passcode •...

  • Page 15: Navigating The Home Screen

    Navigating the Home Screen The Home screen will appear after successful log-in to the CP. The Home screen provides access to the main functions of the CP, including: 1 Lead Placement – Deliver test stimulation during a lead placement procedure. 2 Connect to Patient Device – Check the status of and program a Stimulator.

  • Page 16: Description Of Battery Level Icons And Charging

    When the battery level is low, the supply with the CP. battery displays 1 red bar. Note: The CP should provide 5 or more years of service. With repeated charging, the CP battery may lose capacity. Notify Axonics if you experience a significant change in the operating time for a Note: A procedure should not be started with a low battery to avoid fully charged CP battery. the CP battery dying during the procedure. Two minutes before the CP automatically shuts down due to a critically low battery, the user will be prompted to charge the CP.

  • Page 17: Introduction To Clinician Programmer Prompts

    Introduction to Clinician Programmer Prompts Prompts will present information during CP use in order to confirm user intent and to provide information on action progress and errors. Each prompt presents the following information: 1 Prompt type – An icon indicating the general purpose of the prompt (e.g., progress indicator, error alert) 2 Headline –...

  • Page 18: Understanding Impedance Values

    Understanding Impedance Values Impedance values are important indicators when delivering test stimulation or stimulating with the Stimulator. The impedance values provided by the CP are icons representing the quality of the circuit being used to deliver stimulation. Impedance can be tested when a button is present.

  • Page 19: Controlling Stimulation Amplitude

    Refer to the table (Stimulation Output Ranges) at the end of this section for a summary of maximum achievable stimulation amplitudes under different stimulation conditions. Axonics recommends testing alternative electrode configurations – particularly those with lower impedances if available – to attempt to reduce the stimulation output required to obtain the desired stimulation response.
  • Page 20 Controlling Stimulation Amplitude 4 A slider bar indicates the level of stimulation and can be moved up or down to make large changes to the stimulation amplitude. Note: The slider bar can only be used to change stimulation amplitude when stimulation is off. 5 The gray box between the up and down arrows represents the programmable range of stimulation amplitude, which is 0 to 12.5mA.
  • Page 21 Controlling Stimulation Amplitude Automatic Amplitude Adjustment In the automatic amplitude adjustment mode the stimulation amplitude automatically increases from 0mA to the amplitude value set by the user. The amplitude increase can be stopped, or stimulation can be turned off, at any time. To use the automatic amplitude adjustment feature: Use the slider bar ( 4 ) and up and down arrows ( 3 ) to set a •...
  • Page 22 Controlling Stimulation Amplitude Stimulation output ranges Maximum stimulation current output (from the CP and Stimulator) is dependent on the stimulation settings and impedance values. In the event of high impedances values or high frequency and pulse width, the output stimulation amplitude may be less than the programmed stimulation amplitude. Typical settings are 14 Hz and 210 us with impedance from 600 –...

  • Page 23: Test Stimulation During Lead Implantation

    Test Stimulation During Lead Implantation During lead implant procedures, the CP is used to deliver test stimulation to the foramen needle, the PNE lead, and the tined lead. The test stimulation allows confirmation that the needle and/or leads are placed close to the sacral nerve. This section describes how to use the Lead Placement module of the CP during a lead implant procedure.

  • Page 24: Foramen Needle Test Stimulation

    Foramen Needle Test Stimulation Pressing “Lead Placement” on the Home screen will present a window for selecting which type of lead is being implanted. Select the type of lead being implanted, and then the Foramen Needle Placement screen will appear. This screen shows a visual representation of the foramen needle ( 1 ) and allows test stimulation of the foramen needle.
  • Page 25 Foramen Needle Test Stimulation To deliver stimulation, set the desired stimulation amplitude • on the Stimulation Bar ( 6 ) (see Controlling Stimulation Amplitude for more information). Next press the stimulation button ( 7 ) to turn on stimulation. The stimulation button will light up when stimulation is on. Note: To check the connection between the CP and the foramen needle, press the ”Impedance”...
  • Page 26 • Placement is acceptable. Yellow (“okay”): Stimulation level between 0.05 and 0.30 • mA or between 2.05 and 3 mA. Axonics recommends adjusting the needle placement. (“not recommended”): Stimulation level between 3 • and 12.5 mA. Axonics strongly recommends adjusting the needle placement.

  • Page 27: Pne Lead Test Stimulation

    PNE Lead Test Stimulation When the PNE lead is placed through the Foramen needle, the CP provides test stimulation to help determine if the lead is near the sacral nerve. This screen shows a visual representation of the PNE lead ( 1 ) and allows test stimulation of the PNE lead. To stimulate using the PNE lead: Connect the foramen needle test stimulation cable to the CP •...
  • Page 28 2.05 and 3.00 mA. Axonics recommends adjusting the PNE lead placement. (“not recommended”): Stimulation level between 3.00 • and 12.50 mA. Axonics strongly recommends adjusting the PNE lead placement. Press “Connect to Patient Device” ( 8 ) in the upper right to • move on to connect to the Trial Stimulator.

  • Page 29: Tined Lead Test Stimulation

    (“okay”): Stimulation level between 2 and 3 mA. • Axonics recommends adjusting the lead placement. (“not recommended”): Stimulation level between 3 • and 12.5 mA. Axonics strongly recommends adjusting the lead placement. The threshold value of the selected electrode is updated each time a new test stimulation occurs.
  • Page 30 Tined Lead Test Stimulation To explore the response to stimulation with one electrode. Select the electrode by pressing the electrode on the screen. • The top electrode on the CP screen represents the electrode nearest to the tip of the lead. The rectangle around the selected electrode will not be faded ( 1 ). Adjust the stimulation amplitude ( 2 ).
  • Page 31 Tined Lead Test Stimulation Recording the Motor and Sensory Responses Motor and sensory responses associated with stimulation at each electrode can be manually recorded. Entering the motor and sensory responses is optional. For example, if the patient is not awake during the implant procedure, the sensory response can be left as “None.”...
  • Page 32 Tined Lead Test Stimulation Connect to Patient Device After thresholds are established for each electrode, there are two options: Press “Connect to Patient Device” ( 6 ) to connect to a • Stimulator. Press “Exit” ( 8 ) to exit the Lead Placement module and •...

  • Page 33: Connecting To A Stimulator

    Connecting to a Stimulator The CP can connect to a patient’s external Axonics Trial Stimulator (Model 1601) or implanted Neurostimulator (Model 1101) to check the status of the device and program the device. Connect to a Stimulator There are two ways to access the CP screen that connects to a Stimulator: From the Home screen, press “Connect to Patient Device”...
  • Page 34 Connecting to a Stimulator If the Connect screen is opened after implanting a PNE lead (from the PNE Lead implant screen), the CP will automatically search for the nearest Trial Stimulator ( 1 ). If the Connect screen is opened after implanting a Tined Lead (from the Define Thresholds screen), select the patient device type ( 3 ) : “Implanted” for a Neurostimulator or “External trial” for a Trial Stimulator to initiate a search for a Neurostimulator or Trial Stimulator respectively.
  • Page 35 Connecting to a Stimulator Note: Hold the CP within 1 meter (~ 3 feet) of the targeted device to find the device. If the desired device is not found, move closer and search again by pressing the “Implanted” or “External Trial” buttons ( 3 ).

  • Page 36: Programming The External Trial Stimulator

    Programming the External Trial Stimulator When connected to a patient’s external Axonics Trial Stimulator (Model 1601) the CP allows the user to do the following: Set-up a new Trial Stimulator • View Trial Stimulator status • Program a Trial Stimulator’s stimulation settings • Reset the Trial Stimulator...
  • Page 37 Programming the External Trial Stimulator The Patient Device screen will be displayed when the CP connects to a Stimulator. The Patient Device screen is used to: Set up new Stimulators • Check the status of Stimulators • The following information and functions are available on the Patient Device screen: 1 Basic device information 2 Stimulation control module 3 Electrode impedances 4 Therapy History 5 Current stimulation settings...

  • Page 38: Setting Up A New Trial Stimulator

    Setting Up a New Trial Stimulator There are several steps to set up a new Stimulator. A. A prompt will appear when a new Stimulator is connected if the trial type has not yet been assigned to the Stimulator. Select the type of trial and the Trial Stimulator will be configured appropriately. If the connection to new Stimulator is made from PNE Lead placement, a prompt to select 1 PNE Lead or 2 PNE Leads will be displayed.
  • Page 39 Setting Up a New Trial Stimulator Entering Device Information To edit one of the fields in the Device Info section: Press the corresponding box. • A keyboard will pop-up on the lower part of the screen ( 1 ). • Enter the desired information. • The Patient ID must be a minimum of 4 characters.
  • Page 40 Setting Up a New Trial Stimulator Checking the Lead Connection An icon showing the impedance status of each electrode is shown to the right of the graphic representation of each electrode ( 1 ). See manual section Understanding Impedance Values for more information about the qualitative impedance indicators. The CP automatically checks impedance when it first connects to the Stimulator.
  • Page 41 Setting Up a New Trial Stimulator Completing Set-Up When set up is complete, the Patient Device screen is exited by: Pressing “Disconnect” ( 1 ) to end the connection with the • Stimulator and return to the Home screen. Pressing “Programming” ( 2 ) to proceed to set the Stimulator •...

  • Page 42: Viewing The Status Of A Trial Stimulator

    Viewing the Status of a Trial Stimulator The Patient Device screen for a Stimulator that has already been set-up and programmed will include the following information about the status of the device: Device information ( 1 ): This section includes basic information about the Stimulator, including patient ID, Remote Control ID, Stimulator Model number and Trial Start Date. It also contains an estimate of the percent of battery remaining.
  • Page 43 Viewing the Status of a Trial Stimulator Active Therapy ( 3 ): This area shows the current stimulation settings for the therapy programmed to the Stimulator. For a Trial Stimulator, the active therapy program is indicated by a colored box around the settings for that program. Additionally, the active stimulation settings can be adjusted in the Stimulation Control module ( 4 ).
  • Page 44 Viewing the Status of a Trial Stimulator Therapy History Tab ( 1 ) This tab shows the stimulation settings saved to the Stimulator in the previous 8 stimulation programs. For each set of stimulation settings, additional information is provided including the time period the settings were used and notes entered during the programming session.
  • Page 45 Viewing the Status of a Trial Stimulator Usage Data Pressing the usage data button will open a window that provides detailed data on the stimulation usage during the past 31 days. The buttons on the left allow for viewing of the average amplitude, stimulation on time, or stimulation adjustments. The buttons at the top of the window are for adjusting the number of days data is shown for.
  • Page 46 Viewing the Status of a Trial Stimulator Stimulator Errors If a Stimulator error is present, a “View Error” button will appear to the left of the “Disconnect” button in the lower right corner of the Patient Device screen. When the “View Error” button is pressed, a pop-up will appear ( 1 ) with a description of the error ( 2 ). To resume the communication session and try to resolve the error with reprogramming, press “Clear Error”...
  • Page 47 Viewing the Status of a Trial Stimulator Disconnecting To disconnect from the Stimulator, press “Disconnect” in the lower right ( 1 ). Proceed to Stimulator Programming From the Patient Device screen, navigate to additional screens to program the stimulation settings to the Stimulator ( 2 ).

  • Page 48: Resetting The Trial Stimulator

    Resetting the Trial Stimulator The Stimulator can be reset if there is a need to not deliver stimulation for a period of time (e.g., days or longer) or if it was configured with the wrong trial type. Resetting the EPG puts the Stimulator in a power- conserving state to preserve the battery of the Stimulator and erases all data from the Stimulator.

  • Page 49: Programming The Trial Stimulator

    Programming the Trial Stimulator To program the stimulation settings of the Stimulator, first: Connect to the Stimulator (see manual section Connecting to a • Stimulator). Navigate to the Programming screen from the Patient Device • screen by pressing “Programming” in the top right corner of the Patient Device screen. The Programming screen enables adjustment of the stimulation parameters and delivery of test stimulation.
  • Page 50 Programming the Trial Stimulator Electrode Configuration The CP provides the ability to use automatically generated recommended electrode configurations or to manually set which electrodes are active and inactive during stimulation. Electrode Recommendations The Programming screen displays up to four recommended electrode configurations ( 2 ). These recommendations are intended to provide directional guidance regarding which electrode configurations to test.
  • Page 51 Programming the Trial Stimulator Manually Changing Electrode Configuration The electrode configuration can be manually set by pressing the electrode representations ( 3 ) to toggle each electrode between its possible states. There are 3 possible electrode states: Anode (or “+”) Unassigned Cathode (or “-”) Note: When manually adjusting electrode assignment, invalid configurations may be created. An alert will pop up if an attempt is made to stimulate, or set the therapy settings ( 4 ) with an invalid electrode configuration selected.
  • Page 52 Programming the Trial Stimulator Adjusting parameters Several adjustable stimulation parameters are shown in the “Stimulation Parameters” box ( 5 ). To adjust frequency and pulse width: Press the left and right arrows to the sides of the current value • to incrementally decrease and increase the parameter. Frequency: the stimulation frequency can be adjusted from •...
  • Page 53 Programming the Trial Stimulator Delivering Test Stimulation To deliver test stimulation, set the desired stimulation amplitude on the stimulation bar ( 1 ) (see manual section Controlling Stimulation Amplitude for more information). Then press the stimulation button to deliver stimulation ( 2 ). The stimulation button will light up when Stimulation is on.
  • Page 54 Programming the Trial Stimulator Adding Notes Notes can be added that will be saved when the new stimulation ( 1 ) settings are saved. To add a note, press the note icon that is to the left of the “Set Program” button. This will open the Therapy Note screen. On the Therapy Note screen, press the text field ( 2 ) to type notes.

  • Page 55: Programming The Implanted Neurostimulator

    Programming the Implanted Neurostimulator When connected to a patient’s implanted Neurostimulator (Model 1101) the CP allows the user to do the following: Set-up a new Neurostimulator • View Neurostimulator status • Program a Neurostimulator’s stimulation settings • Hibernate the Neurostimulator •...

  • Page 56: Programming The Implanted Neurostimulator

    Programming the Implanted Neurostimulator The Patient Device screen will be displayed when the CP connects to a Neurostimulator. The Patient Device screen is used Set up new Neurostimulators • Check the status of Neurostimulators • The Patient Device screens are different for a single program Neurostimulator (Figure A) and a dual program Neurostimulator (Figure B).

  • Page 57: Setting Up A New Neurostimulator

    Setting Up a New Neurostimulator There are several steps to set up a new Neurostimulator. A. A prompt will appear when a new Neurostimulator is connected after a lead implant, asking for permission to transfer threshold data that was recorded during the tined lead placement procedure. A summary of the threshold data will then be saved to the device for reference during programming sessions.
  • Page 58 Setting Up a New Neurostimulator Entering Device Information To edit one of the fields in the Device Info section: Press the corresponding box. • A keyboard will pop-up on the lower part of the screen ( 1 ). • Enter the desired information. • The Patient ID must be a minimum of 4 characters. •...
  • Page 59 Setting Up a New Neurostimulator Checking the Lead Connection An icon showing the impedance status of each electrode is shown to the right of the graphic representation of each electrode ( 1 ). See manual section Understanding Impedance Values for more information about the qualitative impedance indicators. The CP automatically checks impedance when it first connects to the Stimulator.

  • Page 60: Viewing The Status Of A Neurostimulator

    Viewing the Status of a Neurostimulator The Patient Device screen for a Neurostimulator that has already been set-up and programmed will include the following information about the status of the device: Device information ( 1 ): This section includes the basic information about the Stimulator, including patient ID, Neurostimulator Model number, Remote Control ID, and Implant Start Date. It also contains an estimate of how often the Neurostimulator needs to be charged at the current stimulation settings.
  • Page 61 Viewing the Status of a Neurostimulator Active Therapy ( 3 ): This area shows the current stimulation settings for the therapy programmed to the Stimulator. A Neurostimulator may have one or two therapy programs. For a single program Neurostimulator, only one program will • be displayed under Active Therapy as shown in figure A. For a dual program Neurostimulators, two programs are • displayed and the active therapy program is indicated by a colored box around the settings for that program as shown in figure B.
  • Page 62 Viewing the Status of a Neurostimulator Therapy History tab ( 5 ) This tab shows the stimulation settings saved to the Stimulator in the previous programming sessions. For each set of stimulation settings, additional information is provided including the time period the settings were used and notes entered during the programming session.
  • Page 63 Viewing the Status of a Neurostimulator Threshold Detail tab ( 6 ) This tab summarizes the stimulation threshold data previously captured. For each electrode, the tab shows the motor response, sensory response, and threshold stimulation amplitude recorded during the tined lead implantation procedure or during a programming session. The color around the threshold amplitude indicates the qualitative assessment of the electrode placement (Red = “Poor”, Yellow = “OK”, Green = “Good”, Gray = “Unknown”).
  • Page 64 Viewing the Status of a Neurostimulator Usage Data (dual program Neurostimulator only) Pressing the usage data button will open a window that provides detailed data on the stimulation usage during the past 31 days. The buttons on the left allow for viewing of the average amplitude, stimulation on time, or stimulation adjustments. The buttons at the top of the window are for adjusting the number of days data is shown for.
  • Page 65 Stimulator. If additional errors exist, the pop-up will display information about the next error, which will also need to be cleared. Press “Close” to exit the pop-up ( 4 ). If the pop-up is exited without clearing the errors, the ability to program the Stimulator may be impaired. Contact Axonics for assistance with Stimulator Errors.
  • Page 66 Viewing the Status of a Neurostimulator Disconnecting To disconnect from the Stimulator, press “Disconnect” in the lower right ( 1 ). Proceed to Stimulator Programming From the Patient Device screen, navigate to additional screens to: Program the stimulation settings to the Stimulator ( 2 ). • Record new stimulation thresholds for each electrode ( 3 ) •...

  • Page 67: Hibernate The Neurostimulator

    Hibernate the Neurostimulator The Neurostimulator can be put into Hibernate Mode if there is a need to not deliver stimulation for a prolonged period of time (e.g., months). For example, if a patient becomes pregnant and needs to discontinue stimulation during the pregnancy, put the device in Hibernate Mode.

  • Page 68: Programming The Neurostimulator

    Programming the Neurostimulator To program the stimulation settings of the Neurostimulator, first: Connect to the Neurostimulator 1 (see manual section • Connecting to the Neurostimulator). Navigate to the Programming screen from the Patient Device • screen by pressing “Programming” 2 in the top right corner of the Patient Device screen. The Programming screen enables adjustment of the stimulation parameters and delivery of test stimulation.
  • Page 69 Programming the Neurostimulator Program Selection (for dual program Neurostimulator only) Select “Program 1” or “Program 2” at the top right of the screen ( 1 ) to pick which of the two stimulation programs to adjust and set (Figure A). Electrode Configuration The CP provides the ability to switch between monopolar and bipolar stimulation modes, to use automatically generated recommended electrode configurations, and to manually set which electrodes are active and inactive stimulation. Monopolar vs Bipolar Stimulation The Programming screen allows the electrode configuration to be set to be “Monopolar”...
  • Page 70 Programming the Neurostimulator Manually Changing Electrode Configuration The electrode configuration can be manually set by pressing the electrode representations ( 1 ) to toggle each electrode between its possible states. There are 3 possible electrode states: Cathode (or “-”) Anode (or “+”) Unassigned If the electrode configuration is in “Monopolar” mode, the Neurostimulator is set as the anode (“+”) and the electrodes can be toggled between cathode (“-”) and unassigned.
  • Page 71 Programming the Neurostimulator Adjusting parameters Several adjustable stimulation parameters are shown in the “Stimulation Parameters” box ( 2 ). To adjust frequency, amplitude range, and pulse width: Press the left and right arrows to the sides of the current value • to incrementally decrease and increase the parameter. Frequency: the stimulation frequency can be adjusted from •...
  • Page 72 Programming the Neurostimulator To adjust cycling and ramping: Cycling and ramping settings are active when settings have been set to the Neurostimulator. Note: The cycling and ramping settings are not active during test stimulation. To test cycling and ramping, save the stimulation settings to the Neurostimulator by pressing “Set Device Therapy” then activate stimulation on the Patient Device screen. Press the button for the parameter and a pop-up will appear for adjusting the setting Cycling 1 Allows stimulation to turn on and off automatically at...
  • Page 73 Programming the Neurostimulator Delivering test stimulation To deliver test stimulation, set the desired stimulation amplitude on the stimulation bar ( 1 ) (see manual section Controlling Stimulation Amplitude for more information). Then press the stimulation button to deliver stimulation ( 2 ). The stimulation button will light up when Stimulation is on. When stimulation is on, the electrode configuration, cycling setting, ramp setting, frequency, and pulse width cannot be changed.
  • Page 74 Programming the Neurostimulator Save Therapy After therapy settings have been configured, press “Set Device Therapy” ( 3 ) to save the settings to the Neurostimulator. In the case of a dual program Neurostimulator, press “Set Program 1” to save program 1 or “Set Program 2” to save program 2 to the Stimulator. For a single program Neurostimulator, a prompt will appear for selecting the Amplitude Step Size.
  • Page 75 Programming the Neurostimulator To exit the Programming screen, press “Patient Device” to return to the Patient Device screen ( 4 ). Note: If “Set Device Therapy” or “Set Program (1 or 2)” is not pressed prior to exiting, the Neurostimulator settings will revert to last saved settings when the Programming screen is exited. When the Programming screen is exited, a prompt will appear requesting confirmation to exit without saving the therapy settings.
  • Page 76 Programming the Neurostimulator Adding Notes Notes can be added that will be saved when the new stimulation settings are saved. To add a note, press the note icon Figure A ( 1 ) that is to the left of the “Set Device Therapy” button. (Figure A) or “Set Program 1 (or 2)” button (Figure B). This will open the Therapy Note screen.

  • Page 77: Updating Stimulation Thresholds

    Updating Stimulation Thresholds The thresholds saved to the Neurostimulator can be updated in the Define Thresholds screen. The screen displays the currently saved threshold data until test stimulation is delivered to set new thresholds. For more information on setting thresholds, see Define Thresholds in the Tined Lead Test Stimulation section of this manual.

  • Page 78: Checking For Mri Readiness

    Checking for MRI Readiness If the patient has a patient Remote Control (manufactured before May 1st, 2020) that does not have the MRI Readiness check capability, whole-body MRI readiness check can be performed using the Clinician Programmer. The following instructions summarize how to check the implanted device for whole-body MRI readiness. Connect to the patient’s Neurostimulator, which will automatically perform an impedance measurement.

  • Page 79: Home Screen Tools

    Home Screen Tools The Home screen will appear after successful log-in to the CP or after exiting any CP function (e.g., “Lead Placement”). The Home screen provides access to tools to assist in data management and the use of the CP, including: 1 CP Settings - Change general CP settings, including default stimulation settings.

  • Page 80: Clinician Programmer Settings

    Clinician Programmer Settings 1 General Settings The General Settings includes basic CP information and adjustable settings like the time and date displayed by the CP. 2 Default Therapy Settings The “Default Therapy Settings” are the stimulation settings that are pre-set on the Programming screen when you connect to a new Stimulator. Changes to the default therapy parameters allow the CP user to start the programming session for all new Stimulators at their most frequently used or preferred stimulation settings.
  • Page 81 Clinician Programmer Settings 7 FCC Information Press this button to see the FCC required information about the wireless communication of this device. This information is also included in this manual in the section Wireless Communication. 8 Advanced Settings These settings are for manufacturer use only.
  • Page 82 Clinician Programmer Settings 1 Set Time Change hour, minute, and time formatting between 12- hour • and 24-hour. Press “Set” to confirm and return to CP Settings screen. • Press “Cancel” to return to CP Settings screen without saving • changes. 2 Set Date Set month, day, year, and date formatting.
  • Page 83 Clinician Programmer Settings User Account Management Multiple functions can be accessed on the User Account Management screen, including: Adding a new user • Press “Add new User” to add a new user ( 1 ). • Enter the user name of the new user on the keyboard that •...

  • Page 84: Reports

    Reports The CP Home screen provides access to the Reports List function of the CP. Reports generated during Stimulator programming sessions can be viewed, saved to an external device, or deleted in the Reports List screen. Reports are listed by the date they were created. Note: A report is generated any time the CP connects to a Stimulator. Note: The USB port is enabled in this screen only. Follow the cautions listed under “Viewing a report”...
  • Page 85 Reports Saving a report Press the box to the left of the date of a report entry. Multiple • boxes may be selected ( 1 ). Press “Save to USB” to save the selected reports to a USB flash • drive connected to the CP USB port ( 3 ). A prompt appears communicating that saving is in progress, •...

  • Page 86: Troubleshooting

    Issue Presentation Resolution CP does not turn on CP does not power • Charge the CP then attempt to turn on the CP. up, including no light • If the CP still does not turn on, contact Axonics. behind power button CP power button Turn the CP off by holding the power button, then turn the CP back on. • lights up but CP If the screen still does not display, contact Axonics. • screen is blank The CP touchscreen CP display is on but •...

  • Page 87: Issues Communicating With A Stimulator

    Remote Control (if one has been paired) that the Stimulator has battery life and Device screen that there is not an error (red light on Remote Control). (For Neurostimulator only) Try charging the Stimulator and then retry connecting to the • Stimulator. • If the error light of the paired Remote Control is on or the CP still cannot connect to the Stimulator, contact Axonics. Communication Error prompt • Move closer to the Stimulator and hit the “Implanted” or “External Trial” button on the with a Stimulator is appears stating that screen to search again. interrupted or lost...

  • Page 88: Issues Delivering Stimulation

    Troubleshooting Issues Delivering Stimulation Issue Presentation Resolution Stimulation is not No motor or If there are no blue bars in the stimulation bar when stimulation is on, there is an issue with • being delivered sensory responses the connection. during lead implant are observed • Check the impedance using the CP. procedure during test • Confirm the device cables are connected correctly. Replace the cables if impedance is bad stimulation when the cables are correctly connected. If stimulation appears to be on, adjust the needle or lead and stimulation amplitude until a •...
  • Page 89 Troubleshooting Issues Delivering Stimulation Issue Presentation Resolution Lack of or change Patients may If the stimulation sensation is associated with a lack of symptom benefit, the following steps in stimulation report they can be taken to assess and troubleshoot the patient’s therapy: sensation are not feeling 1. Check if stimulation is turned on. stimulation or the a. This check can be accomplished by connecting the Clinician Programmer or patient sensation (intensity Remote Control to the stimulator. or location) of 2. Check the electrode impedances to determine if there is a connection issue (e.g., lead stimulation has fracture or short).

  • Page 90: Impedance Issue During Lead Implant

    If the impedance is still bad, replace the ground pad and stimulation cable and refresh • connection or PNE the impedance. lead connection. • If the impedance is still bad, replace the foramen needle and then the CP. • Contact Axonics if the impedance remains bad. Red impedance Check that the tined lead test stimulation cable and ground pad are fully inserted into • icon(s) shows the CP and that the ground pad is on the patient and the clip end of the stimulation on the Define cable is connect to the lead. Thresholds screen Make sure the introducer sheath is withdrawn past the most proximal electrode.

  • Page 91: Impedance Issue With The Stimulator

    Neurostimulator connector block until it cannot be inserted any further. The white checked after the marker on the proximal end of the lead should be inside the Neurostimulator strain lead is inserted into relief. the Neurostimulator. If the lead cannot go all the way in, back out the set screw (turn counterclockwise) and • reinsert the lead. • Press the impedance button to refresh the impedance values. If impedance is still red for any electrode(s), replace the CP and check the impedance. Next replace the Neurostimulator and check the impedance. Next replace the tined lead. • Contact Axonics if the impedance remains bad.

  • Page 92: Label Symbols

    Label Symbols Symbols Description Symbols Description Product Serial Number Pressure limitation Manufacturer Classified by CSA with respect to safety Product Model Number Do not use if package is damaged Authorized representative in the European Manufacturing Date community Protection from the amount of dust and water drops IP21 IEC 60601-1/EN60601-1, Type BF Equipment that would interfere with the operation of the device Non ionizing electromagnetic radiation Industry Canada certification number Conformité Européenne (European Conformity): For USA audiences only: 2019. This symbol means that the device fully Caution: US Federal law restricts this device for sale !USA Rx ONLY complies with AIMD Directive 90/385/EEC (Notified by or on the order of a physician...
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  • Page 96 Modulation Technologies Axonics, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonics.com Tel. +1-877-929-6642 Fax +1-949-396-6321 All Rights Reserved. Copyright 2021. Axonics, Inc. 110-0130-001 rK...

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