Axonics SNM System 1401 User Manual
Charging system
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- User manual (272 pages) ,
- User manual (248 pages) ,
- User manual (55 pages)
Related Manuals for Axonics SNM System 1401
Summary of Contents for Axonics SNM System 1401
- Page 1 Axonics SNM System® Charging System Charging System User Manual Models 1401, 9005, and 9008 !USA Rx ONLY Modulation Technologies...
- Page 2 Axonics®, Axonics Modulation®, Axonics Modulation Technologies®, and Axonics Sacral Neuromodulation System® 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......... 33 Axonics Patient Support ....... . 37...
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Page 5: Introduction
Introduction... - Page 6 The Axonics Sacral Neuromodulation (SNM) therapy is provided to relieve the symptoms of fecal dysfunction. 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.
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Page 7: 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 ■... -
Page 8: 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 9: Charging System Components
Charging System Components Charger Charge Belt Charges the Holds the Stimulator Charger over the Stimulator Dock Carrier Stores and charges Holds the Charger the Charger over the Stimulator Power Supply Connects the Dock to a power source... -
Page 10: 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 11: 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 12 Recommended Use and Care DO NOT Do not let your Stimulator stay at a low battery level for long ✕ periods of time (e.g., weeks). Do not drop the Charger in liquid or clean it with harsh cleaners. ✕ Do not use the Charger near flammable or explosive gases. ✕...
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Page 13: 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 will take 1 to 4 hours depending on the depth of the Stimulator and how the Charger is placed over the Stimulator. -
Page 14: 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 Power Light 1 Power Button... - Page 15 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 Green: this means you can fully charge the Stimulator. ■...
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Page 16: 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 17: 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 18: Where To Place The Charger
Where to Place the Charger For best charging, place the Charger 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 19: How To Charge
How to Charge The Axonics Charging System allows you to choose how you want to charge: Choose how often you want to charge. Charging more often ■ means shorter charge times. Choose from 2 options for holding your Charger in place during ■... -
Page 20: 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. -
Page 21: Choose How To Charge
2) Choose How to Charge The Axonics Charging System allows you to choose how you want to hold your Charger on your skin: A) Carrier B) Belt... -
Page 22: Attach The Carrier
2A) Attach the Carrier Press the carrier onto the bottom of the Charger. The adhesive pads on the carrier should face away from the Charger. Start by pressing with both fingers at the bottom of the inner circle of the carrier. Slide your fingers in opposite directions to the top of the carrier. -
Page 23: Attach The Belt
2B) Attach the Belt 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 24: 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 25: Complete Charging
4) Complete Charging You will hear a set of rising tones repeat 3 times when charging is complete. The Charger indicator light will turn off. This will take 1 to 4 hours for a low battery, depending on the implant depth of your Stimulator and how well the Charger is aligned over the Stimulator. -
Page 26: 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 ■ Damaged Charging System ■... -
Page 27: Troubleshooting Scenarios
Troubleshooting Scenarios Issue Presentation Resolution Charger is not The power light on the Retry placing the Charger, charging the Charger is green. Nothing making sure the Charger Stimulator happens when you place is placed the correct way the Charger over the over your Stimulator Stimulator. - Page 28 Troubleshooting Scenarios Issue Presentation Resolution Check to make sure the Dock will not Charger is placed in Dock Dock is plugged in to an charge the and the power light does outlet using the power Charger not come on. supply. Next, pick up and put the Charger back in the Dock.
- Page 29 Troubleshooting Scenarios Issue Presentation Resolution Stimulator has Over time, the Stimulator If stimulation settings to be charged battery provides 50% less were changed recently, more often stimulation time between the change in charging charges than it did after frequency is expected. If initial programming.
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Page 30: Additional Information
Additional information... -
Page 31: 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. -
Page 32: 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. Carrier: Throw away the Carrier after each use. Do not reuse. Reuse could result in the Carrier and Charger falling off, potentially causing damage to the Charger. -
Page 33: 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 34 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 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 35 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 Carrier and Belt Specifications Item Specification Carrier Material Polypropylene Adhesive Medical grade silicone adhesive...
- Page 36 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 Charging System are not authorized by Axonics and could void FCC and IC certification and negate your authority to use the product.
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Page 37: 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 therapy. Please note that Axonics cannot discuss or comment on your medical condition. -
Page 38: Label Symbols
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 For USA audiences only Caution: US Federal law restricts this device for sale by or on the order of a !USA Rx ONLY physician Refer to instructions for use (Consult accompanying documents) - Page 39 Label Symbols Humidity limitation Pressure limitation Do not use if package is damaged Authorized representative in the European community Protection from the amount of dust and splashing water that would interfere IP24 with the operation of the device. Protection from the amount of dust and vertically dripping water that would IP22 interfere with the operation of the device.
- Page 40 HealthLink Europe Services BV Axonics Modulation De Tweeling 20-22 Technologies, Inc. 5215 MC ’s – Hertogenbosch 26 Technology Drive The Netherlands Irvine, CA 92618 (USA) www.axonicsmodulation.com Tel. +1-877-929-6642 Fax +1-949-396-6321 All Rights Reserved. Copyright 2019. Axonics Modulation Technologies, Inc. 110-0126-001 rA...