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Summary of Contents for Axonics Model 2301
- Page 1 Axonics SNM System® Remote Control Remote Control User Manual Model 2301 Rx ONLY !USA Modulation Technologies...
- Page 2 Axonics Modulation Technologies®, Axonics Sacral Neuromodulation System® and r-SNM® are trademarks of Axonics Modulation Technologies, Inc., registered or pending registration in the U.S. and other countries Caution: The Axonics Sacral Neuromodulation System should be used only on the order of a doctor...
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Page 3: Table Of Contents
Contents Introduction ......... 5 Manual Overview . - Page 4 Specifications ........45 Axonics Contact Information ..... . . 48...
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Page 5: Introduction
Patients are given a Remote Control to monitor the battery status and settings of their Axonics SNM System. This manual describes how to use the Remote Control. Axonics recommends you read this manual before using your Remote Control. -
Page 6: Manual Overview
Manual Overview This manual describes the steps for safe use of your Remote Control. The manual includes: Description of Remote Control buttons, indicators and ■ functions Steps for using your Remote Control ■ Troubleshooting Remote Control issues ■ Additional information about the Remote Control ■... -
Page 7: Refer To Your Therapy Guides
Refer to Your Therapy Guides Refer to the following Therapy Guides which are provided by your doctor for more information regarding your system: Trial System Guide – for more information about the trial ■ stimulation period Patient Therapy Guide – for more information about ■... -
Page 8: Remote Control Precautions
Remote Control Precautions If you have other active implants (such as a pacemaker), ■ the Remote Control may cause issues with such implant(s). Contact your doctor if you experience issues or have any questions. If you have cochlear implants, the external portion of these ■... -
Page 9: Recommended Use And Care
Recommended Use and Care Carry your Remote Control with you at all times in case you need to adjust your stimulation or check the battery status of your Stimulator. If you need to store your Remote Control, put it in a cool, dry place away from direct heat and light. - Page 10 Recommended Use and Care DO NOT Do not drop the Remote Control in liquid or clean it with ✕ harsh cleaners. Do not drop the Remote Control or mishandle it in a way ✕ that causes damage. Do not use the Remote Control near flammable or ✕...
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Page 11: How To Use Your Remote Control
Receive notice of errors in your Remote Control or ■ Stimulator Note: Do not make stimulation changes regularly. Your doctor should change your stimulation settings if needed. Axonics recommends you only change your stimulation if you experience discomfort 11 11... -
Page 12: Summary Of Buttons And Lights
Summary of Buttons and Lights Stimulation Level Active Program Connect Down System Error Stimulator Battery Status 12 12... - Page 13 Summary of Buttons and Lights Stimulation Level Shows the strength of stimulation. Turn up stimulation level or Turn on stimulation to default level. Connect Connect or disconnect the Remote Control to the Stimulator. Down Turn down stimulation level or Turn off stimulation.
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Page 14: How Your Remote Control Communicates With
How Your Remote Control Communicates with Your Stimulator The Remote Control sends and receives signals to and from the Stimulator. Your Remote Control must be near the Stimulator to send and receive signals. Only the Remote Control given to you by your doctor can send and receive signals to and from your Stimulator. -
Page 15: Use Scenarios
Use Scenarios The following pages show how to use Note: If you have your Remote Control to: issues using your Remote Control, 1) Connect to your Stimulator. please refer to the 2) View Stimulator status. Troubleshooting section of this manual. 3) Turn down your stimulation level. -
Page 16: Connect To Your Stimulator
1) Connect to Your Stimulator 16 16... - Page 17 1) Connect to Your Stimulator Hold the Remote Control on the same side of your body as the Stimulator. Press the “Connect” button on the center of the Remote Control. The stimulation level lights will flash. Flashing lights mean the Remote Control is trying to connect to the Stimulator.
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Page 18: View Stimulator Status
2) View Stimulator Status Stimulation Level Active Program Stimulator Battery Status 18 18... - Page 19 2) View Stimulator Status Stimulator battery status lights Solid green: Stimulator battery will last for 4 or more days Flashing green (PS only): Stimulator battery is charging Solid orange: Stimulator battery will last for 2 to 4 days Flashing orange: Stimulator battery will last for 2 days or less Stimulation Level lights No stimulation...
- Page 20 2) View Stimulator Status Active Program Program 1 is active Program 2 is active (TS only)
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Page 22: Turn Down Your Stimulation Level
3) Turn Down Your Stimulation Level... - Page 23 3) Turn Down Your Stimulation Level If you experience discomfort, you can use your Remote Control to turn down stimulation. The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator). Press the “Down” button one time. 2 A.
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Page 24: Turn Up Your Stimulation Level
4) Turn Up Your Stimulation Level... - Page 25 4) Turn Up Your Stimulation Level The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator). Press the “Up” button one time. 2 A. Permanent Stimulator: Watch for the stimulation level lights to increase by one. The Remote Control will vibrate. This may take 3 seconds.
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Page 26: Turn Your Stimulation Off
5) Turn Your Stimulation Off (HOLD) - Page 27 5) Turn Your Stimulation Off If you experience extreme discomfort, you can use your Remote Control to turn off stimulation. The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator). Press and Hold the “Down” button for 5 seconds. Watch for the stimulation level lights to all turn off.
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Page 28: Turn Your Stimulation On
6) Turn Your Stimulation On (HOLD) - Page 29 6) Turn Your Stimulation On The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator). Press and Hold the “Up” button for 5 seconds. Watch for the stimulation level lights to light up. The Remote Control will vibrate. This may take 3 seconds. Note: Stimulation level will be at the level set before turning the Stimulator off.
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Page 30: Monitor Charge Status Permanent Stimulator Only
7) Monitor Charge Status Permanent Stimulator Only The Stimulation Battery Status light will flash green when your Stimulator is charging. When charging is done or if charging stops for any reason, the Stimulation Battery Status light will stop flashing. See the Charging System manual for more information about charging your Stimulator. -
Page 32: Trial Stimulator Only
8) Change Your Stimulation Program Trial Stimulator Only... - Page 33 8) Change Your Stimulation Program Trial Stimulator Only The Remote Control allows you to change the active program (providing stimulation) if your doctor has set 2 programs to your external Trial Stimulator. Only change your program if instructed by your doctor. The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator).
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Page 34: See A System Error
9) See a System Error When you try to connect to your Stimulator, the Remote Control will check for errors. Permanent Stimulator: Call your doctor if the red error light is on. Trial Stimulator: The red light may mean that your Stimulator is disconnected from the cable. -
Page 36: Turn Off Your Remote Control
10) Turn Off Your Remote Control... - Page 37 10) Turn Off Your Remote Control The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator). Press and release the “Connect” button. Watch for all the lights on the Remote Control to turn off. This means the Remote Control has stopped communicating with the Stimulator and is off.
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Page 38: Troubleshooting
Troubleshooting This section will help you solve issues with your Remote Control. Contact your doctor if you need help. Summary of issues addressed in this section: Remote Control will not communicate to Stimulator. ■ System Error light is on. ■ Cannot change stimulation level. - Page 39 Troubleshooting Scenarios Issue Presentation Resolution Remote Control Remote Control Move Remote Control will not connect lights scroll then closer to Stimulator to Stimulator turns off. Battery and retry connection Status indicator is For the PS only, try not on. charging the Stimulator.
- Page 40 Troubleshooting Scenarios Issue Presentation Resolution System Red error Disconnect Remote Control from Error light flashes Stimulator; Press “Up” and “Down” indicator for 12 buttons to check if they are stuck; is visible seconds then Reconnect to Stimulator. turns off. If you have 2 programs available, try switching to the other program.
- Page 41 Troubleshooting Scenarios Issue Presentation Resolution Unable Remote Control connects to Contact your to adjust Stimulator but stimulation doctor. stimulation cannot be turned up or level turned down. Remote Control lights are Reconnect and scrolling or Remote Control retry adjustment. lights are not on. Contact your doctor.
- Page 42 Troubleshooting Scenarios Issue Presentation Resolution Damage to Remote Control Stop use of the Remote Remote Control appears physically Control. Contact your damaged. doctor to discuss replacement. Discomfort or Constant pain or Turn down stimulation pain due to discomfort in the level.
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Page 43: Additional Information
Additional Information... -
Page 44: Replacement And Disposal
Replacement and Disposal Replacement: If your Remote Control is lost or not working, contact your doctor to get a new Remote Control. The Remote Control battery is expected to last up to 5 years. When the battery runs out you should get a new Remote Control. Disposal: Follow your local government rules to dispose of the Remote Control. -
Page 45: Specifications
Specifications 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 – 158°F) Pressure 57kPa – 106kPa Humidity 15% - 95% Storage &... - Page 46 Specifications Expected 5 years Battery Life* Communication Radiofrequency telemetry Model: 2301 IC: 20225-P FCC ID: 2AEEGP 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 USA: FCC 47 CFR Part 95;...
- Page 47 Meteorological Aids, 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 Remote Control not authorized by Axonics could void FCC and IC certification and negate your authority to use the product.
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Page 48: Axonics Contact Information
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 therapy. Please note that Axonics cannot discuss or comment on your medical condition. -
Page 49: Label Symbols
Label Symbols Symbol Description Remote Control Remote Control User Manual (this document) Product Serial Number Manufacturer Product Model Number Manufacturing Date IEC 60601-1/EN60601-1, Type BF Equipment Non ionizing electromagnetic radiation 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) Industry Canada certification number... - Page 50 Label Symbols Symbol Description Classified by CSA with respect to safety For USA audiences only !USA Rx 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...
- Page 52 Modulation Technologies 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 All Rights Reserved. Copyright 2019. Axonics Modulation Technologies, Inc.
Need help?
Do you have a question about the Model 2301 and is the answer not in the manual?
Questions and answers
Why don’t the stimulator lights indicate an increase in strength when I press the increase button?
The Axonics Model 2301 stimulator lights may not indicate an increase in strength when the increase button is pressed for several reasons:
1. Remote Control not connected: The Remote Control must be connected to the Stimulator for adjustments to work.
2. Stimulation already at maximum: If the stimulation level is already at the maximum set by your doctor, no further increase will be shown.
3. Program issue: Only one program may be set. If an attempt to change programs fails, the active program light will flash for several seconds but not change.
4. System error: A red error light may indicate a connection issue or another system error preventing changes.
5. Remote Control issue: If the Remote Control is damaged or malfunctioning, it may not successfully send adjustment commands.
If these steps do not resolve the issue, contact your doctor.
This answer is automatically generated
I want to increase my stimulation, but when I press the increase button, only three indicator lights remain on. The fourth, fifth, sixth and seventh lights do not light up, noting no change in strength. What am I doing wrong?
If the fourth, fifth, sixth, and seventh indicator lights do not light up when trying to increase stimulation, it may mean that the maximum stimulation level has been reached. Stimulation level can only be increased one level at a time, and it may take up to 30 seconds for the level to fully increase. Make sure the Remote Control is connected to the Stimulator and wait to see if the lights change. If they still do not light up, the device may already be at the maximum level set by your doctor.
This answer is automatically generated
I would like to turn remote control off and then back on I did that before and it worked real good but I don't remember how I did it if you could please help me with that and it is a model 2301
To turn off the Axonics Model 2301 Remote Control:
1. Press and release the “Connect” button.
2. Wait for all the lights on the Remote Control to turn off. This means it is off.
The Remote Control will also turn off automatically after 12 seconds of no activity.
To turn it back on:
1. Press and release the “Connect” button again to reconnect to the Stimulator.
This answer is automatically generated