Axonics SNM System 1401 User Manual
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Axonics SNM System 1401 User Manual

Charging system
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Axonics SNM System TM
Charging System
Charging System User Manual
Models 1401, 9005, 9008, 9108

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Summary of Contents for Axonics SNM System 1401

  • Page 1 Axonics SNM System TM Charging System Charging System User Manual Models 1401, 9005, 9008, 9108...
  • Page 2 Axonics® and Axonics Sacral Neuromodulation System® are trademarks of Axonics, Inc., registered or pending registration in the U.S. and other countries. The Axonics Sacral Neuromodulation System Caution: should be used only on the order of a doctor.
  • Page 3 Contents Introduction .............. 9 Manual Overview ............. 11 Refer to Your Patient Therapy Guide ........12 Charging System Components ........... 13...

  • Page 4: Table Of Contents

    Precautions ..............14 Recommended Use and Care ..........16 How to Use Your Charging System ......18 Charger Buttons and Lights ..........19 Charger Sounds and Vibrations ......... 22...
  • Page 5 Initial Set-up ..............23 Where to Place the Charger ..........24 How to Charge ............26 Turn the Charger On ..........28 Attach the Belt .............. 29...
  • Page 6 3) Place the Charger Over the Stimulator......31 4) Complete Charging............35 Troubleshooting ............37 Troubleshooting Scenarios ..........39 Additional Information ..........42...
  • Page 7 Replacement and Disposal ..........43 Care Instructions .............. 44 Specifications ..............45 Access Product Manuals Online ........51 Axonics Patient Support ............ 53...
  • Page 8 Label Symbols..............54...

  • Page 9: Introduction

    Introduction...
  • Page 10 Patients are given a Charging System to charge their Stimulator battery. This manual describes how to use the Charging System. Axonics recommends you read this manual before using your Charging System.

  • Page 11: Manual Overview

    Manual Overview This manual describes how to use your Charging System. The manual includes:  Overview of Charging System buttons, lights, and functions  Steps for using your Charging System  Troubleshooting Charging System issues  Additional information about the Charging System If you have issues with your Charging System, ask your doctor for assistance.

  • Page 12: Refer To Your Patient Therapy Guide

    Refer to Your Patient Therapy Guide Refer to the Patient Therapy Guide that was provided by your doctor for additional information about your Axonics SNM System, including:  Indications for Use  Contraindications  System Warnings  System Precautions  Patient Activity Precautions...

  • Page 13: Charging System Components

    Power Supply Stores and Connects the Dock charges the to a power source Charger Carrier Packaged separately Holds the Charger over the Stimulator Note: Carriers are packaged separately. Contact your doctors office or Axonics Customer Support to inquire about carriers.

  • Page 14: Precautions

    Precautions If you have other active implants (such as a pacemaker), the Charger  may cause issues with such implant(s). Contact your doctor if you experience issues or have any questions. Some equipment may generate signals, called Electromagnetic  Interference or EMI, that block the Charger’s signals to the Stimulator.
  • Page 15 Precautions Do not use the power supply near water. Use in these  conditions could result in shock or serious injury. If you experience skin irritation, redness or heating at the  site of charging, do not continue charging. Do not sit or lie on the Charger during charging as this may ...

  • Page 16: Recommended Use And Care

    Recommended Use and Care √ Develop a habit for charging that fits your schedule (e.g., every Sunday while watching your favorite TV show). You do not need to wait for the Stimulator battery to be low to charge. √ Store your Charger on the Dock between uses. Keep the Dock plugged in so the Charger will be ready when you want to charge.
  • Page 17 Recommended Use and Care DO NOT х Do not let your Stimulator stay at a low battery level for long periods of time (e.g., weeks). х Do not drop the Charger in liquid or clean it with harsh cleaners. х Do not use the Charger near flammable or explosive gases.

  • Page 18: How To Use Your Charging System

    How to Use Your Charging System The Charging System allows you to easily and comfortably recharge your Stimulator battery. When the Charger is placed on the skin over the implanted Stimulator, the Charger will charge the Stimulator battery. Charging a low Stimulator battery typically takes 1 hour depending on the depth of the Stimulator and how the Charger is placed over the Stimulator.

  • Page 19: Charger Buttons And Lights

    Charger Buttons and Lights The Charger has a button and two lights that help you use the Charger. Power Button Turns on or off the Charger Power Light Shows if the Charger has enough battery to charge your Stimulator Error Light Shows if the Charger has an issue...
  • Page 20 Charger Button and Lights Power Button Power Light...
  • Page 21 Charger Button and Lights 1. The power button can be pressed to turn the Charger on and off. When ON, the power light will come on. 2. The power light will be a. Green: this means you can fully charge the Stimulator.

  • Page 22: Charger Sounds And Vibrations

    Charger Sounds and Vibrations What you hear or feel: What it means: One long tone Charger is over the Stimulator and charging has started 3 beeps + vibration Charging has been interrupted and is (repeats) not complete. Three rising tones Stimulator battery is fully charged.

  • Page 23: Initial Set-Up

    Initial Set-up To set up your Charging System, you need to charge your Charger on the Dock.  Plug the power supply into a wall outlet and then into your Dock.  Place the Charger on the Dock. The power light on the Charger will flash green to indicate that the Charger is charging.

  • Page 24: Where To Place The Charger

    Where to Place the Charger For best charging, place the Charger directly over your implanted Stimulator. You should place your Charger with the button facing up if your Stimulator is placed horizontally (as shown to the right). Your doctor will inform you if your Stimulator is placed in a different way.
  • Page 25 Where to Place the Charger The white outline on the green underside of the Charger represents how the Charger should be placed over the Stimulator. Good placement will ensure shortest charging time. The following section will provide the detailed steps for placing the Charger over your Stimulator.

  • Page 26: How To Charge

     Choose how often you want to charge. Charging more often means shorter charge times.  Choose what you want to do while you charge. The Axonics Charging System lets you do basic household activities while charging.
  • Page 27 How to Charge The following pages show the steps to charge your Stimulator. The steps include:  Turn the Charger on  Attach the Belt  Place the Charger over the Stimulator  Complete Charging...

  • Page 28: Turn The Charger On

    1) Turn the Charger On Pick up the Charger from the Dock. The Charger power light should be on. If not, press the power button to turn on the Charger. Note: See section Charger Button and Lights for information on the states of the charger power button. Note: The Charger will turn itself off if it does not detect the Stimulator within 5 minutes...

  • Page 29: Attach The Belt

    2) Attach the Belt 1. Press the green ring of the Belt onto the bottom of the Charger. Start by pressing with both fingers at the bottom of the inner circle of the ring. Slide your fingers in opposite directions to the top of the ring.
  • Page 30 Note: If using the carrier, attach the ring of the carrier to the Charger just as you would the belt. The adhesive pads on the carrier should face away from the Charger. Peel back the protective liner to expose the adhesive.

  • Page 31: Place The Charger Over The Stimulator

    3) Place the Charger Over the Stimulator Hold the Charger over your Stimulator. Continue to slowly move the Charger in that area until you hear one long tone. This indicates the Charger is properly aligned and is charging the Stimulator. The power light on the Charger will flash green when the Charger is charging the Stimulator.
  • Page 32 Place the Charger Over the Stimulator 2. Fix the Charger in place by tightening the Belt around your waist. Be careful not to move the Charger away from your Stimulator. Note: The Charge Belt should be worn directly against the body. Longer charge times will be needed if worn over clothing.

  • Page 33: Complete Charging

    4) Complete Charging 1. You will hear a set of rising tones repeat 3 times when charging is complete. The Charger indicator light will turn off. This will typically take 1 hour for a low battery, depending on the implant depth of your Stimulator and how well the Charger is aligned over the Stimulator.
  • Page 34 2. Remove the Charger from your skin by unstrapping the Belt or peeling off the Carrier. Take the Charger off the Belt or Carrier. 3. Store the Belt or dispose of the Carrier. Place the Charger on the Dock. Note: The Charger should provide 5 or more years of service. With repeated charging, the Charger battery may lose capacity or charge the Stimulator more slowly.

  • Page 35: Troubleshooting

    Troubleshooting This section will help you solve issues with your Charging System. Contact your doctor if you need help. Summary of issues addressed in this section:  Charger is not charging the Stimulator  Dock is not charging the Charger ...

  • Page 36: Troubleshooting Scenarios

    Troubleshooting Scenarios Issue Presentation Resolution Charger is The power light on the Retry placing the Charger, making sure the Charger is green. Nothing Charger is placed the correct way over charging happens when you place the your Stimulator (see “Where to Place the Charger over the Stimulator.
  • Page 37 Troubleshooting Scenarios Issue Presentation Resolution Dock will not Charger is placed in Dock and Check to make sure the Dock is charge the the power light does not come plugged in to an outlet using the Charger power supply. Next, pick up and put the Charger back in the Dock.
  • Page 38 Troubleshooting Scenarios Issue Presentation Resolution Charger has visible Damage to Do not use your charger. Contact your damage Charger doctor to discuss replacement. Stimulator Over time, the Stimulator If stimulation settings were changed battery provides 50% less has to be recently, the change in charging frequency stimulation time between charged...

  • Page 39: Additional Information

    Additional Information...

  • Page 40: Replacement And Disposal

    Replacement and Disposal Replacement: If part of your Charging System is lost or not working, contact your doctor. If you charge using the Carrier, let your doctor know when you have only a few Carriers left so more can be sent to you. Disposal: Follow your local government rules to dispose of the Charging System.

  • Page 41: Care Instructions

    Care Instructions Charger, Dock, and Power Supply: Clean with a damp, soft cloth as needed. Do not use harsh cleaners or abrasive materials to clean these items. Belt: Wash the belt by hand in cold water. Air dry. Do not machine wash or tumble dry as this may damage the belt.

  • Page 42: Specifications

    Specifications Environmental Specifications – Charger, Dock, Power Supply, Carrier and Belt Item Specification Operating Conditions Temperature 5°C - 40°C (41°F – 104°F) Pressure 70kPa – 106kPa Humidity 15% - 95% Storage & Shipment Conditions – Short Term (3 days or less) Temperature -25°C - 70°C (-13°F –...
  • Page 43 Specifications Charger Specifications Item Specification Power source Lithium-ion battery (rechargeable) Size 93 mm x 24.4 mm Weight Approximately 175 g Expected Life* 5 years * Expected life based on typical and worst case use scenario...
  • Page 44 Specifications Charger Specifications Item Specification Communication Radiofrequency telemetry Model: 1401, IC: 20225-D, FCC ID: 2AEEGD 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 45 Specifications Dock Specifications Item Specification Power source Powerbox EMX30 Input Power 100-240 VAC, 47-63 Hz, 15V, 2A Size 19.5 mm x 93.0 mm Weight Approximately 150 g Expected Usable Life* 5 years...
  • Page 46 Specifications Belt and Carrier Specifications Item Specification Belt Model 9008 Model 9108 Material – Band Breathoprene Breathoprene Material – Ring Polypropylene Polypropylene Regular: 112 cm (44 inches) Regular: 112 cm (44 inches) Length Extended: 152 cm (60 inches) Extended: 149 cm (58 inches) Carrier Material Polypropylene...
  • Page 47 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 Charging System are not authorized by Axonics and could void FCC and IC certification and negate your authority to use the product.

  • Page 48: Access Product Manuals Online

    To access an electronic copy of this manual or a French version (for Canada), follow the steps below: 1. If using a web browser, navigate to: www.axonics.com/hcp/resources/resource-library. If using a mobile device, scan the QR Code below with your mobile device camera and tap on the link.
  • Page 49 To request a paper copy, contact Axonics by 1. Emailing customersupport@axonics.com or 2. Calling 1-877-929-6642 to speak with an Axonics Customer Support representative between the hours of 6 am – 6 pm (PST). Please allow approximately 1 to 2 weeks to receive a paper copy of...

  • Page 50: Axonics Patient Support

    Please contact your doctor if you have questions about your health or the Axonics SNM therapy. Axonics Patient Support Axonics, located in Irvine, CA (USA) can help answer questions or concerns about your Axonics SNM System. Please note that Axonics cannot talk about your medical condition.
  • Page 51 Label Symbols Symbol Description Product Serial Number Product Lot Number Manufacturer Product Model Number Manufacturing Date IEC 60601-1/EN60601-1, Type BF Equipment Non ionizing electromagnetic radiation...
  • Page 52 Symbol Description For USA audiences only: Caution: US Federal law restricts this device for sale by or on the order of a physician Refer to instructions for use (Consult accompanying documents) Temperature limitation Humidity limitation Pressure limitation Classified by CSA with respect to safety Follow instructions for use (operator manual)
  • Page 53 Symbol Description Do not use if package is damaged Authorized representative in the European community Protection from the amount of dust and splashing water IP24 that would interfere with the operation of the device. Protection from the amount of dust and vertically IP22 dripping water that would interfere with the operation of the device.
  • Page 54 Symbol Description Conformité Européenne (European Conformity):2019. This symbol means that the device fully complies with AIMD Directive 90/385/EEC (Notified Body reviewed) and RED 2014/53/EU (self-certified) Power on/off button This device complies with all applicable Australian Communications and Media Authority (ACMA) regulatory arrangements and electrical equipment safety requirements US Federal Communications Commission device...
  • Page 55 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. 110-0126-001rF...

This manual is also suitable for:

Snm system 9005Snm system 9008Snm system 9108

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