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Axonics SNM System 2501 Manual

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Sacral Neuromodulation System
Clinician Programmer Manual
Model 2501 Clinician Programmer
Rx only
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Summary of Contents for Axonics SNM System 2501

  • Page 1 Sacral Neuromodulation System Clinician Programmer Manual Model 2501 Clinician Programmer Rx only...
  • Page 2 Neuromodulation System® and r-SNM® 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 Purpose of the trial system ............................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 ..........................
  • Page 4 Table of Contents 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 Test Stimulation During Lead Implantation ......................... 26 Foramen Needle Test Stimulation .................................27 PNE Lead Test Stimulation ..................................30 Tined Lead Test Stimulation ..................................33...
  • Page 5 Table of Contents Issues Communicating with a Stimulator ..............................65 Issues delivering stimulation .................................66 Impedance Issue during lead implant ..............................69 Impedance Issue with the Stimulator ..............................70 Label Symbols ................................71...

  • Page 6: Introduction

    Caution: Do not sterilize any part of the Clinician Programmer. Sterilization may damage the programmer 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: 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 ⚠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: 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.

  • Page 12: Wireless Communication

    Device Specifications Wireless Communication  Radiofrequency telemetry  Model: 2501  IC: 20225-C  FCC ID: 2AEEGC  Quality of Wireless Service:  This device operates in the 401-406 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 EN ETSI 302-537 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 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: •...

  • Page 15: Summary Of Clinician Programmer Buttons And Connections

    The purposes and uses of these buttons and connections Note: EMG functionality (③, ④, ⑤) is not available in are described throughout this manual. this model of the Axonics Clinician Programmer. Note: The USB port is disabled in all screens, except Reports List Screen (see section Programming Session...

  • Page 16: 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.

  • 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 functions of the CP, including: ① Lead Placement – Deliver test stimulation during a lead placement procedure.

  • Page 19: Description Of Battery Level Icons And Charging

    CP. 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

    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 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 ⑤ The gray box between the up and down arrows represents the when stimulation is off.
  • Page 24 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 desired stimulation amplitude.
  • Page 25 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 26: Test Stimulation During Lead Implantation

    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.

  • Page 27: Foramen Needle Test Stimulation

    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 implant. Select the type of lead being implanted, and then the Foramen Needle Placement screen will appear.
  • Page 28 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.
  • Page 29 • Yellow (“okay”): Stimulation level between 2 and 3 mA. Axonics recommends adjusting the needle placement. • Red (“not recommended”): Stimulation level between 3 and 12.5 mA. Axonics strongly recommends adjusting the needle placement. • Press (⑧) in the upper right to move on to place the tined lead.

  • Page 30: Pne Lead Test Stimulation

    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.
  • Page 31 • Green (“good”): Stimulation level between 0 and 2 mA. Placement is acceptable. • Yellow (“okay”): Stimulation level between 2 and 3 mA. Axonics recommends adjusting the PNE lead placement • Red (“not recommended”): Stimulation level between 3 and 12.5 mA. Axonics strongly recommends adjusting the PNE lead placement.
  • Page 32 • Green (“good”): Stimulation level between 0 and 2 mA. Placement is acceptable. • Yellow (“okay”): Stimulation level between 2 and 3 mA. Axonics recommends adjusting the tined lead placement. • Red (“not recommended”): Stimulation level between 3 and 12.5 mA. Axonics strongly recommends adjusting the tined lead placement.

  • Page 33: Tined Lead Test Stimulation

    Tined Lead Test Stimulation updated each time a new test stimulation occurs. 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.
  • Page 34 Tined Lead Test Stimulation 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 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 •...

  • Page 36: Programming The Stimulator

    Programming the Stimulator Programming the stimulator The CP can connect to a patient’s external Axonics Trial Stimulator (Model 1601) to check the status of the device and program the device. This section explains how to: • Connect to a Stimulator •...

  • Page 37: Connecting To A Stimulator

    Connecting to a Stimulator Connecting to a stimulator he CP will automatically search for the nearest Stimulator (①). A scrolling search icon will appear when the CP is searching for Stimulators (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 Stimulator 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 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...

  • Page 40: Setting Up A New Stimulator

    Setting up a New Stimulator Setting up a New 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.
  • Page 41 Setting up a New 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. •...
  • Page 42 Setting up a New 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.

  • Page 43: Viewing The Status Of A Stimulator

    Viewing the Status of a Stimulator Viewing the Status of a 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”...
  • Page 44 Viewing the Status of a 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, and Trial Start Date.
  • Page 45 Viewing the Status of a Stimulator Active Therapy (③): This area shows the current stimulation settings for the therapy programmed to the 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 46 Viewing the Status of a Stimulator Therapy History tab (①) This tab shows the stimulation settings saved to the Stimulator 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 Stimulator Usage Data Pressing the usage data button will open a window that provides detailed data on the stimulation usage during the past 30 days. The buttons on the left allow for viewing of the average amplitude, stimulation on time, or stimulation adjustments.
  • Page 48 Viewing the Status of a Stimulator Viewing the Status of a Stimulator Stimulator Errors If a Stimulator 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”...
  • Page 49 Viewing the Status of a 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 50: Resetting The Stimulator

    Resetting the Stimulator Resetting the 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 51: Programming The Stimulator Stimulation Settings

    Programming the Stimulator Stimulation Settings Programming the Stimulator Stimulation Settings 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”...
  • Page 52 Programming the Stimulator Stimulation Settings 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).
  • Page 53 Programming the Stimulator 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 “+”) Unassigned Note: When manually adjusting electrode assignment, invalid configurations may be created.
  • Page 54 Programming the Stimulator Stimulation Settings 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.
  • Page 55 Programming the Stimulator Stimulation Settings To adjust ramping: • Ramping settings are active when settings have been set to the Stimulator. Note: The ramping settings are not active during test stimulation. To test ramping, save the stimulation settings to the Stimulator by pressing “Set Device Therapy”.
  • Page 56 Programming the Stimulator 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 Stimulator 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 note icon (①) that is to the left of the “Set Device Therapy” button. This will open the Therapy Note screen.

  • Page 58: 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, ①CP Settings - Change general CP settings, including including: default stimulation settings.

  • Page 59: Clinician Programmer Settings

    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.
  • Page 60 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 61 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...

  • Page 62: Programming Session Reports

    Programming Session Reports Programming Session 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.
  • Page 63 Programming Session Reports Note: A standard USB flash storage device with capacity of 32GB or less is recommended. Larger capacity devices may not be supported. Caution: Check the USB flash storage drive with a virus or malware protection program before plugging the USB flash drive into the USB port.

  • Page 64: Troubleshooting

    • unresponsive respond to touch. CP back on. If the screen still does not respond to touch, contact Axonics. • CP screen fails during use CP display turns blank during use Check the CP power light to see if the CP is no longer on.

  • Page 65: Issues Communicating With A Stimulator

    (red light on Remote Control). If the error light of the paired Remote Control is on or the • CP still cannot connect to the Stimulator, contact Axonics. Communication with Error prompt appears stating that Move closer to the Stimulator and hit the “Scan Again”...

  • Page 66: Issues Delivering Stimulation

    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 •...
  • Page 67 Issues delivering stimulation 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.
  • Page 68 Issues delivering stimulation Issue Presentation Resolution 6. Note: If the stimulation amplitude is high (>4mA), selecting another electrode configuration may provide adequate therapy at a lower amplitude. 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...

  • 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 Stimulator

    Refresh the impedance values. • •If the bad impedance is still present, reprogram the stimulation using electrodes with in-range impedance values. • •If impedance is still bad on all electrodes, device replacement may be necessary. Contact Axonics.

  • Page 71: 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 IPX0 The device does not offer protection against IEC 60601-1/EN60601-1, Type BF water Equipment...
  • Page 72 USB port Foramen Needle Test Stimulation This device complies with all applicable FCC ID Australian Communications and Media US Federal Communications Commission device Authority (ACMA) regulatory identification arrangements and electrical equipment safety requirements...
  • Page 73 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. 110-0137-001 rA...

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