Related Manuals for Axonics SNM System 2301
Summary of Contents for Axonics SNM System 2301
- Page 1 Axonics SNM System® Remote Control Remote Control User Manual Model 2301 For Use With: • Model 1601 • Model 1101 (not applicable in EU) • Model 4101 (not applicable in EU) • Model 5101...
- 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. Caution: The Axonics Sacral Neuromodulation System should be used only on the order of a doctor.
-
Page 3: Table Of Contents
Contents Introduction ......... 1 Manual Overview . - Page 4 Electromagnetic Compatibility ......46 Axonics Patient Support ......60 Axonics Contact Information .
-
Page 5: Introduction
(not applicable in EU) 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: Precautions
Warning: Do not attempt to modify or service this product. If there is an issue with the product, please consult your doctor. For more information about Axonics SNM System warnings, precautions, and adverse events, refer to your Therapy Guide. Additional safety information can also be found at... -
Page 8: 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 9 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 explosive gases.
-
Page 10: Summary Of Lights And Buttons
Summary of Lights and Buttons LIGHTS BUTTONS Stimulation Level Active Program Connect Down Stimulator Battery Status System Error... - Page 11 Summary of Lights and Buttons Stimulation Level Shows the strength of stimulation Active Program Shows which stimulation program is active Stimulator Shows the remaining battery level in the Battery Status Stimulator Turn up stimulation level or Turn on stimulation to default level Connect Connect or disconnect the Remote Control to the Stimulator...
-
Page 12: How Your Remote Control Communicates
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 14: Connect To Your Stimulator
1) Connect to Your Stimulator... - Page 15 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.
-
Page 16: View Stimulator Status
2) View Stimulator Status Stimulation Level Active Program Stimulator Battery Status... - Page 17 2) View Stimulator Status Stimulation Level lights No stimulation Default level set by your doctor Maximum level Active Program Program 2 is selected Program 1 is selected...
- Page 18 2) View Stimulator Status Active Program Note: After you connect your Remote Control, if your stimulation is Off, you will still see a light under Program 1 or 2, depending on which program was last selected. Stimulation On Stimulation Off Level 3, Program 1 Program 1 14 14...
- Page 19 2) View Stimulator Status Check Your Battery Status Trial Stimulator 1601 and Permanent Stimulator Model 1101 (Rechargeable): Solid green: Stimulator battery will last for 4 or more days. Flashing green (Model 1101, Rechargeable only): Stimulator battery is charging. Solid orange: Stimulator battery will last for 2 to 4 days.
- Page 20 2) View Stimulator Status Permanent Stimulator Model 5101 (Rechargeable): Solid green: Stimulator battery will last for 30 or more days. Flashing green: Stimulator battery is charging. Solid orange: Stimulator battery will last for 7 to 30 days. Flashing orange: Stimulator battery will last for 7 days or less.
- Page 21 2) View Stimulator Status Permanent Stimulator Model 4101 (Recharge-Free): Solid green: Stimulator battery level is not low. Solid orange: Stimulator battery level is low. The battery may provide therapy for several months before the system shuts off. (Talk to your doctor about replacing your Stimulator.) Flashing orange: Stimulator battery level is very low.
-
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. The Remote Control will vibrate and the stimulation level lights will flash.
-
Page 24: Turn Up Your Stimulation Level
4) Turn Up Your Stimulation Level... - Page 25 Make sure the stimulation level is comfortable before turning up again. 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.
-
Page 26: Turn Your Stimulation Off
5) Turn Your Stimulation Off... - 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.
-
Page 28: Turn Your Stimulation On
6) Turn Your Stimulation On... - 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.
-
Page 30: Monitor Charge Status
7) Monitor Charge Status Permanent Stimulator Models 1101, 5101 (Rechargeable) 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. -
Page 32: Change Your Stimulation Program
8) Change Your Stimulation Program... - Page 33 8) Change Your Stimulation Program The Remote Control allows you to change the active program (providing stimulation) if your doctor has set 2 programs to your Stimulator. Only change your program if instructed by your doctor. The Remote Control must be connected to the Stimulator (see Connect to Your Stimulator).
-
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. Red light flashes - Call your doctor and ask for a new Remote Control. Red light is on at all times- •... -
Page 36: Perform An Mri Readiness System Check
10) Perform an MRI Readiness system check prior to a Full Body MRI exam Permanent Stimulators (1101, 5101, and 4101) Bring the Remote Control and your patient ID card to the MRI appointment. Use the Remote Control to perform an MRI Readiness check of your system prior to an MRI. - Page 37 10) Perform an MRI Readiness system check prior to a Full Body MRI exam Permanent Stimulators (1101, 5101, and 4101) C. Press and hold the Down button for at least 5 seconds. i. If the system is ready for MRI scan, stimulation level lights 3, 4 and 5 will light up and the Remote Control will vibrate.
-
Page 38: Turn Off Your Remote Control
11) Turn Off Your Remote Control... - Page 39 11) 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.
-
Page 40: 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 Remote Control will not communicate to Stimulator •... - Page 41 Troubleshooting Scenarios Issue Presentation Resolution Remote Control Remote Control Move Remote Control will not connect lights scroll then closer to Stimulator to Stimulator turn off. Battery and retry connection. Status indicator is For Models 1101 and not on. 5101 (Rechargeable) Permanent Stimulators only, try charging the Stimulator.
- Page 42 Troubleshooting Scenarios Issue Presentation Resolution System Red error Disconnect Remote Control from light flashes Stimulator; Press “Up” and “Down” Error for 12 buttons to check if they are stuck; indicator seconds then Reconnect to Stimulator. is visible turns off. If you have 2 programs available, try switching to the other program.
- Page 43 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 44 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.
-
Page 45: Additional Information
Additional Information... -
Page 46: 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 47: Specifications
Specifications Environmental 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 –... - Page 48 Specifications Item Specification Power source Lithium-ion battery (non-rechargeable) Size 7.1 x 3.8 x 1.6 cm Weight 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...
- Page 49 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.
-
Page 50: Electromagnetic Compatibility
Electromagnetic Compatibility Electromagnetic compatibility, or EMC, means that a device’s electromagnetic (EM) environment does not cause interference, and the device does not emit levels of EM energy that cause electromagnetic interference (EMI) in other nearby devices. Rules and regulations set by the Federal Communication Commission (FCC) and international agencies minimize interference between electronic devices. - Page 51 Essential Performance Any failure within the Axonics Sacral Neuromodulation System does not result in performance that can lead to unacceptable risk to the user or patient. Quality of Wireless Service The Axonics Sacral Neuromodulation System uses the Half-Duplex, Direct point-to-point, primary- secondary communication system in the FCC MedRadio frequency band (401 MHz –...
- Page 52 Electromagnetic Compatibility regulation part 47 CFR 95i. If interferences are detected, the Axonics system will perform another clear channel assessment and select another channel to continue communications. ◊ Communication failures can occur if signal-to-noise ratio is low. Axonics system will attempt multiple retries to transmit.
- Page 53 Electromagnetic Compatibility The Axonics Sacral Neuromodulation System® complies to the EMC and wireless requirements of the following standards: • AIM 7351731:2017, Rev. 2.00 • ANSI IEEE C63.27:2017 • IEC 60601-1-2:2014, 4th ed. • IEC 60601-1-11:2015, 2nd ed. • IEC/TR 60601-4-2:2016, 1st ed.
- Page 54 Electromagnetic Compatibility Table 1 – Compliance level for Immunity tests Guidance and manufacturer’s declaration - electromagnetic immunity The Remote Control is intended for use in the electromagnetic environment specified below. The customer or the user of the Remote Control should assure that it is used in such an environment.
- Page 55 Electromagnetic Compatibility Immunity Test IEC/EN 60601 test Compliance Electromagnetic level level environment - guidance Voltage dips, short Not Applicable Not Applicable interruptions and voltage Applicable variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) 30 A/m at 50 Hz 30 A/m Power frequency magnetic field...
- Page 56 Electromagnetic Compatibility Immunity Test IEC/EN 60601 test Compliance Electromagnetic level level environment - guidance Immunity to conducted Not Applicable Not Applicable disturbances, induced by Applicable radio-frequency fields acc. to IEC 61000-4-6...
- Page 57 Electromagnetic Compatibility Table 2 – Test levels for Proximity fields from RF wireless communications equipment Test Immunity Band Compliance Frequency Service Modulation Test Level level V/m Pulse Modulation 380 - 390 TETRA 400 18Hz FM ± 5kHz GMRS 460 430 – 470 deviation 1kHz FRS 460 Sine Wave...
- Page 58 Electromagnetic Compatibility Test Immunity Band Compliance Frequency Service Modulation Test Level level V/m 1720 GSM 1800 CDMA 1900 1845 1700 – Pulse Modulation DECT 1990 217 Hz LTE Band 1970 1,3,4,25,UMTS Bluetooth WLAN 2400 – Pulse Modulation 2450 802.11b/g/n 2570 217 Hz RFID 2450 LTE Band 7...
- Page 59 Electromagnetic Compatibility Table 3 – Test levels for radiated and conducted Immunity Tests Guidance and manufacturer’s declaration - electromagnetic immunity The Remote Control is intended for use in the electromagnetic environment specified below. The customer or the user of the Remote Control should assure that it is used in such an environment.
- Page 60 Electromagnetic Compatibility Immunity IEC/EN 60601 Compliance Electromagnetic environment - guidance Test test level level d = 1.2 √ P 80 MHz to < 800 MHz d = 2.3 √ P 800 MHz to < 2.7 GHz Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
- Page 61 Electromagnetic Compatibility Table 4 – Emission class and group Guidance and manufacturer’s declaration - electromagnetic emissions The Remote Control is intended for use in the electromagnetic environment specified below. The customer or the user of the Remote Control should assure that it is used in such an environment Emissions test Compliance...
- Page 62 Electromagnetic Compatibility Table 5 – Test levels for RFID Immunity testing to AIM 7351731 RFID Frequency Immunity Test Level Compliance Level 134.2 KHz 65 A/m 65 A/m 13.56 MHz 5 A/m - 12 A/m 5 A/m - 12 A/m 433.92 MHz 3 V/m 3 V/m 860-960 MHz...
-
Page 64: Axonics Patient Support
Please contact your doctor if you have questions about your health or the Axonics SNM therapy. Axonics Contact Information 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 65: Adverse Event Reporting In Eu
Axonics Patient Support Adverse Event Reporting in EU In case of any serious incident related to the product, please report to Axonics by emailing customersupport@axonics.com as well as the competent authority of your state, which can be found here: https://www.ema.europa.eu/en/partners-... -
Page 66: 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) This symbol means that the device fully complies with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR). - Page 67 Label Symbols Symbol Description Industry Canada certification number Classified by CSA with respect to safety This device is restricted for sale by or on the order of a physician Refer to instructions for use (Consult accompanying documents) Temperature limitation Humidity limitation Pressure limitation Do not use if package is damaged Authorized representative in the European community...
- Page 68 Label Symbols Symbol Description This device complies with all applicable Australian Communications and R-NZ Media Authority (ACMA) regulatory arrangements and electrical equipment safety requirements FCC ID US Federal Communications Commission device identification Medical Device Importer...
- Page 69 This page left blank intentionally.
- Page 70 This page left blank intentionally.
- Page 71 This page left blank intentionally.
- Page 72 Emergo Europe B.V. Axonics, Inc. Westervoortsedijk 60 15515 Sand Canyon Ave 6827 AT Arnhem Irvine, CA 92618, USA The Netherlands www.axonics.com Fax +1-949-396-6321 2797 2025-02 All Rights Reserved. Copyright 2025. 110-0125-001 Rev S...
Need help?
Do you have a question about the SNM System 2301 and is the answer not in the manual?
Questions and answers