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Axonics 1501 Programmer's Manual

Sacral neuromodulation system
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Sacral Neuromodulation System
Clinician Programmer Manual
Model 1501 Clinician Programmer
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Summary of Contents for Axonics 1501

  • Page 1 Sacral Neuromodulation System Clinician Programmer Manual Model 1501 Clinician Programmer Rx only...
  • Page 2 Neuromodulation System® are trademarks of Axonics Modulation Technologies, 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 ................................. 6 Axonics SNM System for Bowel Control ........................7 Indications ........................................ 7 Precautions ......................................7 Contraindications ..................................... 7 Precautions .................................. 8 Parameter adjustment ..................................... 8 Sensitivity to stimulation ..................................8 Programmer interaction with flammable atmospheres .......................... 8 Programmer interaction with other active implanted devices .......................
  • Page 4 Table of Contents Start Up and General Functions ........................... 14 Summary of Clinician Programmer Buttons and Connections ......................15 Turning the Clinician Programmer on and Off ............................16 Logging-in to the Clinician Programmer ..............................17 Navigating the Home Screen .................................18 Description of Battery Level Icons and Charging ...........................19 Introduction to Clinician Programmer Prompts ............................20 Understanding Impedance Values .................................21 Controlling Stimulation Amplitude ................................22...
  • Page 5 Table of Contents User Account Management ...................................63 Troubleshooting ................................. 64 Issues with the CP display ..................................64 Issues Communicating with a Neurostimulator ............................65 Issues Delivering Stimulation .................................66 Impedance Issue During Lead Implant ..............................69 Impedance Issue with the Neurostimulator ............................70 Label Symbols ................................71...

  • Page 6: Introduction

    Introduction Introduction This manual provides information about the Model 1501 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 1101 Neurostimulator  Axonics Model 1201 Tined Lead ...

  • Page 7: Axonics Snm System For Bowel Control

    Axonics SNM System for Bowel Control Axonics SNM System for Bowel Control Indications Axonics SNM Therapy for bowel control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. Precautions Clinician Training ...

  • Page 8: Precautions

    EMI. 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.

  • Page 9: Warnings

    Warnings Warnings ⚠Warning: Do not attempt to modify or service this product. If there is an issue with the product, please consult an Axonics representative. ⚠Warning: Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as diathermy) should not be used during implantation of the Axonics SNM System or on patients implanted with the Axonics SNM System.

  • Page 10: Device Specifications

    *Note: Battery life may vary depending on frequency of use Storage and Usage Environment Usage environment The following lists the appropriate temperature, humidity, and pressure condition for use of the Axonics CP: Temperature: 5 °C to 35 °C  Humidity: 15% to 95% ...

  • Page 11: Shipping And Storage Environment

     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.

  • Page 12: Wireless Communication

    Device Specifications Wireless Communication  Radiofrequency telemetry  Model: 1501  IC: 20225-C  FCC ID: 2AEEGC  Quality of Wireless Service:  This device operates in the 402-405 MHz frequency and the maximum effective radiated power is below the limit of 25 µW ERP/EIRP as specified in EU: EN ETSI 301-839 and USA: FCC 47 CFR Part 95;...
  • Page 13 Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. Note: Changes and modifications to the Clinician Programmer are not authorized by Axonics and could void FCC and IC certification and negate the user’s authority to use the product.

  • Page 14: 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 •...

  • Page 15: Summary Of Clinician Programmer Buttons And Connections

    Summary of Clinician Programmer Buttons and Connections Summary of Clinician Programmer Buttons and Connections The CP has two physical buttons: ① Power Button – turns the CP on and off. ② Stimulation Button – turns test stimulation on and off (select screens only) The CP has a Connector Panel with plugs for the cables that are used with the CP.

  • Page 16: Turning The Clinician Programmer On And Off

    Turning on the CP • Press and hold the power button (①) to turn on the • The CP screen will show the Axonics logo as the CP starts up. • The CP will proceed to the password protected Log-In screen.

  • Page 17: Logging-In To The Clinician Programmer

    Logging-in to the Clinician Programmer Logging-in to the Clinician Programmer • A key pad will appear when a • When the CP is turned on, it • A short list of names will will start-up at the Log-In appear when the down arrow is user name is selected.

  • Page 18: Navigating The Home Screen

    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 ①Lead Placement – Deliver test stimulation during a functions of the CP, including: ②Connect to Patient Device –...

  • Page 19: Description Of Battery Level Icons And Charging

    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 fully charged CP battery.

  • Page 20: Introduction To Clinician Programmer Prompts

    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: ①Prompt type – An icon indicating the general purpose the prompt (e.g., progress indicator, error alert) ②Headline –...

  • Page 21: Understanding Impedance Values

    Controlling Stimulation Amplitude Understanding Impedance Values Impedance values are important indicators when delivering test stimulation or stimulating with the Neurostimulator. 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 22: Controlling Stimulation Amplitude

    Refer to the table 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 23 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 ⑤...
  • Page 24 Controlling Stimulation Amplitude turned on by pressing the stimulation button (⑧), which lights up when stimulation is on. When stimulation is on, the amplitude can only be adjusted using the up and down arrows. Stimulation is turned off by pressing the stimulation button (⑧) again.
  • Page 25 Controlling Stimulation Amplitude • The stimulation amplitude will start increasing from 0mA at a rate of 0.2mA per second, and the output stimulation amplitude will be visible in the digital display (②) at the top of the stimulation bar. A red bar on the stimulation bar will represent the stimulation amplitude as it increases (⑨).
  • Page 26 Controlling Stimulation Amplitude Stimulation output ranges Maximum stimulation current 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.

  • Page 27: Test Stimulation During Lead Implantation

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

  • Page 28: Foramen Needle Test Stimulation

    Foramen Needle Test Stimulation Foramen Needle Test Stimulation Pressing “Lead Placement” on the Home screen opens the Foramen Needle Placement screen. This screen shows a visual representation of the foramen needle (①) and allows test stimulation of the foramen needle. To stimulate using the foramen needle: •...
  • Page 29 • Green (“good”): Stimulation level between 0 and 3 mA. Placement is acceptable. • Yellow (“okay”): Stimulation level between 3 and 4 mA. Axonics recommends adjusting the needle placement. • Red (“not recommended”): Stimulation level between 4 and 12.5 mA. Axonics strongly recommends adjusting the needle placement.

  • Page 30: Initial Tined Lead Placement

    Define Tined Lead Thresholds Initial Tined Lead Placement When the tined lead is initially placed through the introducer sheath, the CP provides test stimulation to help determine if the lead electrodes are near the sacral nerve. This section explains how the Initial Lead Placement screen can assist in determining if the lead is in an appropriate location.
  • Page 31 Define Tined Lead Thresholds • Select the stimulation amplitude (④) and turn on stimulation by pressing the stimulation button (⑤). (See manual section Controlling Stimulation Amplitude for more information). • The CP will deliver 1 second of stimulation to each electrode at the selected amplitude.

  • Page 32: Define Tined Lead Thresholds

    • Green (“good”): Stimulation level between 0 and 3 mA. Placement is acceptable. • Yellow (“okay”): Stimulation level between 3 and 4 mA. Axonics recommends adjusting the lead placement. • Red (“not recommended”): Stimulation level between 4 and 12.5 mA. Axonics strongly recommends adjusting the lead placement.
  • Page 33 Define Tined Lead Thresholds 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).
  • Page 34 Define Tined Lead Thresholds Manually 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 35 Define Tined Lead Thresholds 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 Neurostimulator if the Neurostimulator will be implanted during the same procedure. •...

  • Page 36: Programming The Neurostimulator

    Programming the Neurostimulator The CP can connect to a patient’s implanted Axonics Neurostimulator (Model 1101) to check the status of the device and program the device. This section explains how to: • Connect to a Neurostimulator • Set-up a new Neurostimulator •...

  • Page 37: Connecting To A Neurostimulator

    Connecting to a Neurostimulator Connecting to a Neurostimulator The CP will automatically search for the nearest Neurostimulator (①). A scrolling search icon will appear when the CP is searching for Neurostimulators (②). The CP will display the nearest patient device (③). Check the Device ID and the Patient ID to determine if this is the correct device.
  • Page 38 Connecting to a Neurostimulator To connect to one of the “Additional Devices”, press the device name to select a device. Press “Connect” when it appears to the right of the Patient ID (①) to connect to the device. The CP will display a prompt with a progress indicator as it connects to the patient device.

  • Page 39: Patient Device Screen Overview

    Patient Device Screen Overview Patient Device Screen Overview The Patient Device screen will be displayed when the CP connects to a Neurostimulator. The Patient Device screen is used to: • Set up new Neurostimulators • Check the status of Neurostimulators The following information and functions are available on ①Basic device information the Patient Device screen:...

  • Page 40: Setting Up A New Neurostimulator

    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.
  • Page 41 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. •...
  • Page 42 Setting up a New Neurostimulator Checking the tined 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.
  • Page 43 Setting up a New Neurostimulator Completing Set-Up When set up is complete, the Patient Device screen is exited by: • Pressing “Disconnect” (①) to end the connection with the Neurostimulator and return to the Home screen. • Pressing “Programming” (②) to proceed to set the Neurostimulator stimulation settings.

  • Page 44: Viewing The Status Of A Neurostimulator

    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 basic information about the Neurostimulator, including patient ID, Remote Control ID, and Implant Date.
  • Page 45 Viewing the Status of a Neurostimulator Active Therapy (③): This area shows the current stimulation settings for the therapy programmed to the Neurostimulator. Additionally, the active stimulation settings can be adjusted in the Stimulation Control Module (④). This area is intended for basic adjustments to the stimulation being delivered.
  • Page 46 Viewing the Status of a Neurostimulator Therapy History tab (①) This tab shows the stimulation settings saved to the Neurostimulator in the previous 4 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 47 Viewing the Status of a Neurostimulator Neurostimulator Errors If a Neurostimulator error is present, a “Query Fault” button will appear to the right of the “Disconnect” button in the lower right corner of the Patient Device screen. When the “Query Fault” button is pressed, a pop-up will appear (①) with a description of the error (②).
  • Page 48 Viewing the Status of a Neurostimulator Disconnecting To disconnect from the Neurostimulator, press “Disconnect” in the lower right (①). Proceed to Neurostimulator Programming From the Patient Device screen, navigate to additional screens to: • Program the stimulation settings to the Neurostimulator (②).

  • Page 49: Hibernate Mode

    Hibernate Mode Hibernate Mode 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 50: Programming The Neurostimulator Stimulation Settings

    Programming the Neurostimulator Stimulation Settings Programming the Neurostimulator Stimulation Settings To program the stimulation settings of the Neurostimulator, first: • Connect to the Neurostimulator (see manual section Connecting to a Neurostimulator). • Navigate to the Programming screen from the Patient Device screen by pressing “Programming”...
  • Page 51 Programming the Neurostimulator Stimulation Settings 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 during stimulation. Monopolar vs Bipolar Stimulation The Programming screen allows the electrode ①).
  • Page 52 Programming the Neurostimulator Stimulation Settings 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: Cathode (or “-”) • Anode (or “+”) •...
  • Page 53 Programming the Neurostimulator Stimulation Settings Typical invalid electrode configurations include: • More than 2 cathodes • 2 cathodes that are not adjacent electrodes • More than 1 anode Adjusting parameters Several adjustable stimulation parameters are shown in the “Stimulation Parameters” box (⑤). To adjust frequency, amplitude range, and pulse width: •...
  • Page 54 Programming the Neurostimulator Stimulation Settings • Amplitude Range • The baseline stimulation level is set by the stimulation level slider. When therapy is saved to the Neurostimulator, the stimulation amplitude shown will be the default stimulation amplitude. • The amplitude range sets the highest and lowest stimulation level that the patient can reach using the Remote Control.
  • Page 55 Programming the Neurostimulator Stimulation Settings 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”.
  • Page 56 Programming the Neurostimulator Stimulation Settings 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 57 Programming the Neurostimulator Stimulation Settings Adding Notes Notes can be added that will be saved when the new stimulation settings are saved. To add a note, press the (①) that is to the left of the “Set note icon Device Therapy” button. This will open the Therapy Note screen.

  • Page 58: Updating Stimulation Thresholds

    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 Tined Lead Thresholds in the Test Stimulation During Lead Implantation section of this manual.

  • Page 59: 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, ①...

  • Page 60: General Clinician Programmer Settings

    General Clinician Programmer Settings ① General Clinician Programmer Settings 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 Neurostimulator.
  • Page 61 General Clinician Programmer Settings ⑥ 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. ⑦ Advanced Settings These settings are for manufacturer use only.
  • Page 62 General 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.

  • Page 63: User Account Management

    User Account Management 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 appears.

  • Page 64: Troubleshooting

    CP does not power up, including Charge the CP then attempt to turn on the CP. • no light behind power button If the CP still does not turn on, contact Axonics. • CP does not turn on CP power button lights up but Turn the CP off by holding the power button, then turn the •...

  • Page 65: Issues Communicating With A Neurostimulator

    If a Remote Control has not been paired, try charging the • Neurostimulator After charging, retry connecting to the Neurostimulator. • If the Remote Control error light is on or the CP still • cannot connect to the Neurostimulator, contact Axonics.

  • Page 66: Issues Delivering Stimulation

    Issues Delivering Stimulation Issue Presentation Resolution If there are no blue bars in the stimulation bar when • Stimulation is not being No motor or sensory responses are stimulation is on, there is an issue with the connection. delivered during lead observed during test stimulation Check the impedance using the CP.
  • Page 67 Issue Presentation Resolution a. A solid red light on the patient Remote Control may indicate a connection (impedance) issue. b. Connecting the stimulator to the Clinician Programmer provides access to detailed impedance data and further information if a device issue is present. 3.
  • Page 68 Issue Presentation Resolution 7. If the above checks and reprogramming do not result in adequate stimulation being delivered, the clinician should consider and investigate other potential causes for the loss or change in stimulation, including but not limited to: lead migration, sub-optimal lead placement, or other factors.

  • Page 69: Impedance Issue During Lead Implant

    • If the impedance is still bad, replace the foramen needle and then the CP. • Contact Axonics if the impedance remains bad. Red impedance icon(s) shows on • Check that the tined lead test stimulation cable and ground...

  • Page 70: Impedance Issue With The Neurostimulator

    • 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. Out of range ("Bad") Red impedance icon(s) shows •...

  • Page 71: Label Symbols

    Not used USB port Foramen Needle Test Stimulation Caution: USB port is for Axonics use only. Do not plug any devices into this port. This device complies with all applicable Australian Communications and Media Authority (ACMA) regulatory arrangements and electrical equipment safety requirements...
  • Page 72 HealthLink Europe Services BV Axonics Modulation Technologies, Inc. De Tweeling 20-22 26 Technology Drive 5215 MC ’s-Hertogenbosch Irvine, CA 92618 (USA) The Netherlands www.axonicsmodulation.com Tel. +1-877-929-6642 Fax +1-949-396-6321 10/23/2019 All Rights Reserved. Copyright 2019. Axonics Modulation Technologies, Inc. 110-0132-001 rA...

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