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Axonics 1101 Manual

Sacral neuromodulation system
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Sacral Neuromodulation System
Neurostimulator Implant Manual
Model 1101 Neurostimulator
Rx only
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.
1

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Summary of Contents for Axonics 1101

  • Page 1 Sacral Neuromodulation System Neurostimulator Implant Manual Model 1101 Neurostimulator Rx only 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.
  • Page 2 Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonicsmodulation.com Tel. +1-(877) 929-6642 Fax +1-(949) 396-6321...

  • Page 3: Label Symbols

    LABEL SYMBOLS This section explains the symbols found on the product and packaging. Symbol Description Axonics Neurostimulator Axonics Torque Wrench Neurostimulator default waveform with 14 Hz frequency, 0 mA amplitude and 210 µs pulse width Neurostimulator default electrode configuration: Electrode 0:...
  • Page 4 Symbol Description Manufacturer Product Model Number Manufacturing Date Non ionizing electromagnetic radiation Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (Notified Body reviewed) and RED 2014/53/EU (self- certified) Refer to instructions for use (Consult accompanying documents) Temperature limitation...
  • Page 5 Symbol Description Do not reuse Sterilized using Ethylene oxide Use by Do not use if package is damaged Do not re-sterilize Authorized representative in the European community Open here For USA audiences only Caution: U.S. Federal law restricts this device for sale by or on the order of a physician �...
  • Page 6 Symbol Description Magnetic Resonance (MR) Conditional Industry Canada certification number This device complies with all applicable Australian Communications and Media Authority (ACMA) regulatory arrangements and electrical equipment safety requirements FCC ID US Federal Communications Commission device identification...

  • Page 7: Table Of Contents

    TABLE OF CONTENTS LABEL SYMBOLS ............3 TABLE OF CONTENTS ..........7 INTRODUCTION ............9 INDICATIONS, WARNINGS, AND PRECAUTIONS ............9 DEVICE DESCRIPTION .......... 10 Package Contents ............. 10 System Registration Form and Patient Identification Card ................. 11 STORAGE AND USAGE .......... 12 Sterilization ..............
  • Page 8 X-RAY IDENTIFICATION ........16 NEUROSTIMULATOR IMPLANT PROCEDURE............. 17 Procedure Supplies ............17 Neurostimulator Preparation ........... 17 Creating the Neurostimulator Pocket ........ 18 Connecting the Lead to the Neurostimulator ....19 Implanting the Neurostimulator ........22 Completing the Implant Procedure ........24 Post-Surgery Treatment ...........

  • Page 9: Introduction

    INTRODUCTION This manual provides information about the Axonics Sacral Neuromodulation (SNM) System Neurostimulator (Model 1101), which is a part of the Axonics SNM System. The Neurostimulator is connected to the Axonics Tined Lead (Model 1201 or 2201). Indications, Warnings, and Precautions •...

  • Page 10: Device Description

    DEVICE DESCRIPTION The Axonics Neurostimulator (Figure 1) is part of the Axonics SNM System. The Neurostimulator is a programmable device that is connected to the Axonics tined lead, which conducts stimulation pulses to the sacral nerve. Figure 1: Axonics Neurostimulator.

  • Page 11: System Registration Form And Patient Identification Card

    System Registration Form and Patient Identification Card The system registration form registers the device and creates a record of the device in Axonics’ implant data system. The patient identification card is also packaged with this device. The patient should carry the identification card at...

  • Page 12: Storage And Usage

    Storage and Usage Environment Component Packaging – Any component that has been compromised in any way should not be implanted. Do not implant the component if any of the following have occurred: The storage package or sterile pack has been •...

  • Page 13: Sterilization

    Temperature (long term): 20 C to 30 • Humidity (short term: 3 days): 15% to 95% • • Humidity (long term): 30% to 85% Pressure (short term): 57 kPa to 106 kPa • • Pressure (long term): 70 kPa to 106 kPa If the Neurostimulator is exposed to extreme temperatures, it may be permanently damaged and should not be used, even if it has returned to a temperature that...

  • Page 14: Specifications

    SPECIFICATIONS Table 1 shows the Neurostimulator physical specifications. For detailed descriptions and specifications for other components and accessories, refer to the product literature packaged with those devices. Table 1: Neurostimulator Specifications. Physical Height 42 mm Attributes Length 22 mm Thickness 6 mm Weight 11 grams...
  • Page 15 Note: All dimensions are approximate. *Battery life estimated at nominal and worst case stimulation settings. Nominal: 1 mA, 14 Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms. Worst case: 4 mA, 14 Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms.

  • Page 16: X-Ray Identification

    X-RAY IDENTIFICATION The radiopaque marker allows physicians to identify the manufacturer and model number under standard x-ray procedures. For the Axonics Neurostimulator, the designated code is AXA, which appears as light characters on a black background (Figure 2). Figure 2: The Axonics Neurostimulator radiopaque...

  • Page 17: Neurostimulator Implant Procedure

    NEUROSTIMULATOR IMPLANT PROCEDURE The following section describes the procedure for implanting the Axonics Neurostimulator. This procedure should be performed when an Axonics tined lead has already been implanted. Procedure Supplies In addition to the general surgical tools required by the...

  • Page 18: Creating The Neurostimulator Pocket

    Creating the Neurostimulator Pocket 1. The Neurostimulator will be placed in a subcutaneous pocket at the anterior surface of the muscle in the upper buttock area. Create a small incision, slightly larger than the smaller dimension of the Neurostimulator, and then bluntly dissect a subcutaneous pocket.

  • Page 19: Connecting The Lead To The Neurostimulator

    Figure 3: Axonics Neurostimulator Implantation Position. 2. Use the tunneling tool to create a tunnel from the lead incision site to the neurostimulator pocket. Refer to the Tined Lead Manual for detailed tunneling and lead implant instructions. Connecting the Lead to the Neurostimulator 1.
  • Page 20 3. Use the torque wrench to turn the setscrew counterclockwise to back up the setscrew. Do not remove the setscrew from the connector block (Figure Figure 4: Use the Torque Wrench to Turn the Setscrew Counterclockwise to Back up the Neurostimulator Setscrew and Allow for Insertion of the Lead.
  • Page 21 Figure 5: Insert Lead Fully into the Neurostimulator Connector Block. ⚠ Cautions: • Avoid pulling the lead body taut when implanted. Do not attempt to insert the lead into the • Neurostimulator if the setscrew is not sufficiently retracted as doing so may cause damage to the lead and/or cause the lead to not seat fully into the connector block.

  • Page 22: Implanting The Neurostimulator

    5. Fully insert the torque wrench into the hole of the Neurostimulator connector block. Tighten the setscrew by turning the torque wrench clockwise until it clicks (Figure 6). Figure 6: Secure the Lead by Tightening the Setscrew Clockwise onto the Retention Sleeve. ⚠...
  • Page 23 recharging (Figure 3). The etched writing can face either towards or away from the muscle tissue. Ensure that the lead curves gently away from the Neurostimulator with no sharp bends. Note: The Neurostimulator should be placed no deeper than 3.0 cm (about 1 in) below the skin and should be parallel to the skin.

  • Page 24: Completing The Implant Procedure

    Neurostimulator. 4. Complete the system registration paperwork and return to Axonics. 5. Schedule the patient’s follow-up visits at regular intervals to ensure that the stimulation is programmed optimally.
  • Page 25 Caution: Replace any device that shows signs of damage, pitting, or corrosion. 5. Set aside the explanted components, which should be returned to Axonics. 6. Connect the lead and replacement Neurostimulator according to the steps above. Return explanted devices to Axonics using materials provided.

  • Page 26: Wireless Communication

    WIRELESS COMMUNICATION Model: 1101 IC: 20225-X FCC ID: 2AEEGX FCC Compliance This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including...
  • Page 27 Note: Changes and modifications to the Neurostimulator are not authorized by Axonics could void FCC and IC certification and negate the user’s authority to use the product. Quality of Wireless Service: This device operates in the 402-...

  • Page 28: Customer Service

    CUSTOMER SERVICE For questions regarding the Axonics SNM System, call our Customer Support Center toll-free at +1-877-929-6642. Additional information and product manuals can be found at our website: www.axonics.com...
  • Page 29 HealthLink Europe Services BV De Tweeling 20-22 5215 MC ’s-Hertogenbosch The Netherlands (2020-05-11) All Rights Reserved. Copyright 2020. Axonics Modulation Technologies, Inc. 110-0127-001 Rev B...

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