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Bioventus bioness L100 Go User Manual

Functional electrical stimulation system
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Innovations For Active Healing
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355, USA
Telefon: 800-211-9136
E-Mail: info@bioness.com
Website: www.bioness.com
EMERGO EUROPE
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Rx Only
©2023 Bioness Inc.
612-00955-001 Rev. F
01/2023
MEDICAL - APPLIED CURRENT/ENERGY EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH:
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA-C22.2No. 60601-1 (2014)
E489148

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  • Page 1 Innovations For Active Healing Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355, USA Telefon: 800-211-9136 E-Mail: info@bioness.com Website: www.bioness.com EMERGO EUROPE Westervoortsedijk 60 6827 AT Arnhem The Netherlands Rx Only MEDICAL - APPLIED CURRENT/ENERGY EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH: ©2023 Bioness Inc.
  • Page 2 Functional Electrical Stimulation System USER’S GUIDE...
  • Page 4 L100 Go User’s Guide Copyright © 2021, Bioness Inc. All Rights Reserved No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Bioness Inc.

  • Page 5: List Of Symbols

    List of Symbols Caution Warning Double Insulated (Equivalent to Class II of IEC 536) Type BF Applied Part(s) Non-Ionizing Radiation Date of Manufacture Manufacturer This Product Must Not Be Disposed of with Other Household Waste Refer to Instruction Manual/Booklet Re-Order Number Lot Number Serial Number Single Patient Use - To Prevent Cross Contamination...

  • Page 6: Table Of Contents

    Table of Contents Chapter 1: Introduction ................... Chapter 2: Safety Information ................ Indications for Use ......................3 Contraindications ......................3 Warnings ........................3 Precautions ........................4 Adverse Reactions ......................7 Skin Care Guidelines ...................... 7 Incident Reporting ......................8 Chapter 3: Environmental Conditions that Affect Use ......... Radio Frequency (RF) Communication Information ............
  • Page 7 Testing the Position of the Lower Leg Cuff ..............28 Removing the Lower Leg Cuff ..................28 Chapter 7: Operating the L100 Go System ........... 29 Turning the L100 Go System On/Off ................29 Selecting an Operating Mode (Gait Mode and Training Mode) ........29 Adjusting Stimulation Intensity ..................

  • Page 8: Chapter 1: Introduction

    Chapter Introduction Central nervous system (CNS) injuries often cause a gait disorder called foot drop. People who have foot drop are unable to raise their foot while walking. They often drag their foot, resulting in instability and increased effort during gait. The L100 Go System is designed to improve gait in people suffering from foot drop.
  • Page 9 This L100 Go User's Guide describes: • Important safety information about the L100 Go System. • The components of the L100 Go System. • How to set up, operate, and maintain your L100 Go System. • Troubleshooting information. Be sure to review this guide with your clinician before using your L100 Go System. If you have any questions contact Bioness Technical Support at 800.211.9136, Option 3.

  • Page 10: Chapter 2: Safety Information

    Chapter Safety Information Indications for Use The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot;...

  • Page 11: Precautions

    • The long-term effects of chronic electrical stimulation beyond 12 months have not been established.. • The Lower Leg Cuff should not be worn over swollen, infected, or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins. •...
  • Page 12 • Some patients may experience a skin irritation, an allergic reaction, or hypersensitivity to the electrical stimulation or the electrical conductive medium. Irritation may be avoided by having your clinician change the stimulation parameters, type of electrodes, or electrode placement. •...
  • Page 13 • Protect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, snow, etc. • Do not leave the L100 Go System stored where temperatures may exceed the acceptable environmental range: -25°C to 55°C (-13°F to 131°F). Temperature extremes can damage the components.

  • Page 14: Adverse Reactions

    or approved components and parts. Adverse Reactions In the unlikely event that any of the following occurs, stop using your L100 Go System immediately and consult your physician: • Signs of significant irritation or pressure sores where the Lower Leg Cuff contacts the skin.

  • Page 15: Incident Reporting

    • After taking off the Lower Leg Cuff, always re-cover Hydrogel Electrodes with the protective plastic covers, where applicable. • Excess body hair where the electrodes adhere may reduce electrode contact with the skin. If necessary, remove excess body hair with an electric shaver or scissors.

  • Page 16: Chapter 3: Environmental Conditions That Affect Use

    Chapter Environmental Conditions that Affect Use Radio Frequency (RF) Communication Information Several components of the L100 Go System communicate via radio communication and have been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 (RF Devices) of the FCC (Federal Communications Commission) Rules.

  • Page 17: Travel And Airport Security

    This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. Travel and Airport Security The L100 Go System charger with interchangeable charging adapters is compatible with Australian, U.K., European Union, and U.S. voltages: 100-240V, 50/60 Hz. Turn off your L100 Go System before going through airport security.

  • Page 18: Warnings

    Warnings • Do not use the L100 Go System within three feet (1 meter) of shortwave or microwave therapy equipment. Such equipment may produce instability in the output of the EPG. • Remove the L100 Go System before undergoing any diagnostic or therapeutic medical procedure such as Xray examination, ultrasound, Magnetic Resonance Imaging (MRI), etc.
  • Page 19 User's Guide...

  • Page 20: Chapter 4: L100 Go System Kits

    Chapter L100 Go System Kits Contents L100 Go System, Lower Leg • Box Container • Regular Lower Leg, Right or Left, with (Universal) Strap 2797 • Central Electronic Pulse Generator (EPG) 2797 • System Charger (with charging adapters) 2797 • Magnetic Charging Cable 2797 •...
  • Page 21 Regular Lower Leg FS Lower Leg Cuff Strap Cuff with EPG (example shown) System Charger with Magnetic Charging Cord User's Guide...

  • Page 22: Chapter 5: Device Description

    Chapter Device Description Lower Leg Cuff The Lower Leg Cuff is an orthosis that fits on the leg below the knee and is designed to facilitate upward movement of the foot and toes. See Figure 5-1. The Lower Leg Cuff is available in right and left configurations. The Lower Leg Cuff houses the EPG cradle, the lower leg EPG, and integrated electrodes.

  • Page 23: Lower Leg Epg

    Lower Leg EPG The lower leg EPG generates the electrical stimulation used to contract the muscles in the leg that lift the foot and toes. The lower leg EPG features a built-in motion sensor, that detects the position of the foot and it communicates via Bluetooth ®...
  • Page 24 • Stimulation is being delivered (feedback set by the clinician) • When an error is detected • When battery level is low The EPG provides vibration feedback when: • An EPG button is pushed • Stimulation is being delivered • When detecting an error Display Description Definition...

  • Page 25: Lower Leg Cuff Electrodes And Electrode Bases

    EPG Button Description Function Power button Turns the System On or Off Turns Stimulation On or Off in the Stim button Current Selected Mode Plus button Increase Stimulation Intensity Minus button Decrease Stimulation Intensity Table 5-2: EPG Button Functions L100 Go System Operating Modes The L100 Go System has two operating modes: gait and training.
  • Page 26 snap onto the Lower Leg Cuff liner or the electrode snaps directly into the Lower Leg Cuff. With a regular L100 Go System the following electrodes and electrode bases can be used (See Figure 5-5): • Quick Fit Electrode, left or right •...

  • Page 27: Mybioness ™ Mobile Application

    System Charger Set The system charger set includes a dual USB 3.1A 15w AC adapter, charging adapters for U.S. and international outlets, and a magnetic USB charging cable. The system charger set connects to a main power supply and is used to charge the EPG battery. See Figure 5-6.

  • Page 28: Chapter 6: Setup Instructions

    Chapter Setup Instructions Charging the L100 Go System The lower leg EPG is the only L100 Go System components that can be charged. It is important to charge your EPG(s) daily and for at least four hours before a fitting/ programming session.
  • Page 29 Figure 6-2: L100 Go System Charging Setup 4. Plug the AC adapter with connected magnetic USB charging cable(s) into a power outlet. 5. The battery indicator light on the EPG(s) will flash green to indicate charging. 6. The battery indicator light on the EPG(s) is a solid green when the system is fully charged.

  • Page 30: Preparing The Skin

    Caution: To completely disconnect the power input, the AC adapter portion of the System Charger Set must be disconnected from the main power supply. Preparing the Skin Before putting on the Lower Leg Cuff, always check your skin for signs of irritation. If any irritation is present, do not put on the Lower Leg Cuff and contact your clinician.
  • Page 31 5. Align the orange and blue snaps on the Quick Fit Electrode with the orange and blue plug holes on the Lower Leg Cuff. See Figure 6-4. 6. Press firmly to snap the Quick Fit Electrode into the Lower Leg Cuff. See Figure 6-4.
  • Page 32 Round Cloth Electrodes To attach the Round Cloth Electrodes: 1. Make sure the lower leg EPG is turned off. 2. If attached, gently pull the Round Cloth Electrodes from the electrode bases. Be careful not to detach the electrode bases from the Lower Leg Cuff. 3.

  • Page 33: Positioning The Lower Leg Cuff

    Note: Remove and re-wet the Round Cloth Electrodes every time you remove the Lower Leg Cuff from your leg for more than one hour, and after every three to four hours of use. When wetting the electrodes, always remove them from the Lower Leg Cuff.
  • Page 34 Figure 6-8: Positioning the Lower Leg Cuff on the Leg 3. Hold the cuff in place and lower the Lower Leg Cuff until it rests flush against your leg. 4. Grasp the handle of the Lower Leg Cuff strap. See Figure 6-9. With your thumb on the Lower Leg Cuff cradle, fasten the strap handle around the cradle.

  • Page 35: Testing The Position Of The Lower Leg Cuff

    Lower Leg Cuff Figure 6-10: Lower Leg Cuff fastened on the leg Testing the Position of the Lower Leg Cuff 1. Press the Power button on the lower leg EPG. The EPG will give vibration and audio feedback when turned on. 2.

  • Page 36: Chapter 7: Operating The L100 Go System

    Chapter Operating the L100 Go System Turning the L100 Go System On/Off To turn on the L100 Go System, press the Power button once on the lower leg EPG. The system will be in a ready state. All indicator lights will light up for a few seconds while the system performs a self-test.

  • Page 37: Audio And Vibration Feedback During Stimulation

    To adjust stimulation intensity (for patients using the Lower Leg Cuff): Press the Plus or Minus button on the EPG to increase or decrease the stimulation intensity. Audio and Vibration Feedback During Stimulation The EPG has the capability to provide audio and vibration feedback when stimulation is being delivered.

  • Page 38: Chapter 8: Maintenance And Cleaning

    Chapter Maintenance and Cleaning Daily Maintenance and Storage 1. For the Hydrogel Electrodes reapply the covers to the Hydrogel Electrodes when the Lower Leg Cuff is not in use. 2. For the Round Cloth Electrodes detach the electrodes from the electrode bases when the Lower Leg Cuff is not in use.

  • Page 39: Replacing The Quick Fit Electrodes

    and storage conditions. An EPG battery can be expected to last several years when maintained accordingly. For support with your device, contact the Bioness Client Support Department, at 800.211.9136, Option 3 (USA & Canada) or your local distributor. Replacing the Quick Fit Electrodes You will need to replace the Quick Fit Electrodes at least every two weeks or sooner if they become worn.
  • Page 40 Figure 8-3: Replacing the Quick Fit Electrode Remove and re-wet the entire Quick Fit Electrode every time you remove the Lower Leg Cuff from your leg for more than one hour, and after every three to four hours of use. When wetting the Quick Fit Electrode, always remove it from the Lower Leg Cuff. Chapter 8 - Maintenance and Cleaning...

  • Page 41: Replacing The Round Cloth Electrodes

    If the Quick Fit Electrode dries out, your response to the stimulation may change. If you need to adjust stimulation intensity more often than usual, try re-wetting or replacing the electrode. Note: When not in use, store the Quick Fit Electrode where it can air dry. Replacing the Round Cloth Electrodes You will need to replace the Round Cloth Electrodes at least every two weeks or sooner if they become worn.

  • Page 42: Replacing The Hydrogel Electrodes

    Figure 8-4: Wetting and Removing Excess Water Figure 8-5: Attaching the Round Cloth Electrodes Note: When not in use, store the Round Cloth Electrodes where they can air dry. Replacing the Hydrogel Electrodes For Lower Leg Cuff users the Hydrogel Electrodes are one of the electrode options for home use.
  • Page 43 To replace the Hydrogel Electrodes: (See Figure 8-6) 1. Make sure the lower leg EPG is turned off. 2. Gently pull the used Hydrogel Electrodes from the electrode bases. Be careful not to detach the electrode bases from the Lower Leg Cuff. 3.

  • Page 44: Replacing The Electrode Bases

    Figure 8-6: Replacing the Hydrogel Electrodes Replacing the Electrode Bases Depending on use, it may be necessary to replace the electrode bases after one year of use. Contact Bioness to purchase replacement electrode bases. For regular Lower Leg Cuff users, if you are switching from Hydrogel Electrodes to Round Cloth Electrodes, or from Round Cloth Electrodes to Hydrogel Electrodes, you will need to be seen by a trained clinician for a first fitting.
  • Page 45 2. Mark the position of the used electrode bases on the Lower Leg Cuff liner with a permanent marker. See Figure 8-7. 3. Disconnect the electrode base snaps from the plug holes. See Figure 8-8. Figure 8-7: Mark Position of Electrode Base (Left) Disconnect Electrode Base Snaps (Right) 4.

  • Page 46: Removing The Epg

    Figure 8-9: Attaching New Electrode Bases (Left) Connecting Electrode Base Snaps (Right) Removing the EPG The lower leg EPG should only be removed for maintenance and to clean the Lower Leg Cuff. To remove the EPG: 1. Make sure the EPG is turned off. 2.

  • Page 47: Cleaning Your L100 Go System Components

    Figure 8-10: Removing the EPG The system consists of mechanical and electronic components. Inadequate handling of those components may cause health hazards. Disposal of the system must comply with local regulations. Cleaning Your L100 Go System Components All L100 Go System components may be cleaned by carefully by wiping them with a damp cloth.

  • Page 48: Disinfecting Your L100 Gosystem Components

    3. Immerse the Lower Leg Cuff for 30 minutes in lukewarm water and mild detergent. Do not use a washing machine. 4. Rinse the Lower Leg Cuff thoroughly under running water. 5. Immerse the Lower Leg Cuff for an additional 15 minutes in clean, lukewarm water.
  • Page 49 Do not use other cleaning/disinfecting agents such as a diluted bleach mixture, or other disinfecting wipes. Bioness has not tested these products' effectiveness on the L100 Go System components. User's Guide...

  • Page 50: Chapter 9: Troubleshooting

    Chapter Troubleshooting If you have any questions or concerns, please contact the Bioness Client Relations Department at 800.211.9136, Option 3 or visit the Bioness website at www.bioness.com. Error Code Descriptions When an error occurs with the L100 Go System the EPG will emit an audio alert and the Status Indicator Light on the EPG will display a flashing red light.
  • Page 51 Error Code Description of Error Solution Electrodes are worn or damaged. Replace any worn or damaged electrodes or electrode bases. Bad Electrode Fault Refer to the "Maintenance and Cleaning" chapter of this guide for instructions. Turn the EPG off by pressing the Power button on the EPG.

  • Page 52: Testing The Functionality Of The Alert Indicator

    Testing the Functionality of the Alert Indicator Do not test the functionality of the alert indicator while wearing the Lower Leg Cuff. Remove the Lower Leg Cuff before starting the test. To test the functionality of the alert indicator: 1. Remove the electrodes from the Lower Leg Cuff. 2.
  • Page 53 What should I do if the electrodes or electrode bases are frayed, peeling, damaged, or falling off the Lower Leg Cuff? • Replace any worn or damaged electrodes or electrode bases. Refer to the "Maintenance and Cleaning" chapter in this guide. What if my ankle is not moving (or my foot does not lift satisfactorily), and the L100 Go System is not indicating any errors? •...

  • Page 54: Chapter 10: Technical Specifications

    Chapter Technical Specifications EPG Specifications Internally powered, continuous operation with type BF applied Classification part(s) Battery Type Rechargeable lithium ion battery, 3.7V, 1000 mAh • Power button - turns system on/off • Stim button- to turn stimulation on/off Controls • Minus and Plus buttons- to decrease or increase stimulation intensity level •...
  • Page 55 EPG Specifications IP42 Protection Against: • >1mm Solids Ingress • Dripping Water When Tilted up to 15° Ingress Protection Rating Effective Against: • Most wires, screws, etc. • Vertical dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15° from its normal position.
  • Page 56 Interphase 50, 100, 200 Interval (µsec) Total Pulse Duration for Interphase Interval of 50 µsec Asymmetric Positive Pulse Duration (µsec) Negative Pulse Duration (µsec) Interphase 20, 50, 100, 200 Interval (µsec) Total Pulse Duration for Interphase 1050 1250 Interval of 50 µsec Max Load 80000 ohm (Subject to max voltage limitation)
  • Page 57 EPG Alert Onset Time Incorrect Stimulation Delay to Alert < 5 sec Communication Failure Delay to Alert < 1 sec Corrupted Memory Delay to Alert < 100 ms Delay to Alert (after stimulation is enabled) EPG is in the Incorrect Cuff <...
  • Page 58 Output Voltage 5.0 V • USB 1: 2.1 A Current • USB 2: 1.0 A Note: Do not use the L100 Go System while charging. Do not wear the Lower Leg Cuff while charging. Electrode and Electrode Base Specifications–Lower Leg Cuff •...
  • Page 59 User's Guide...

  • Page 60: Chapter 11: Wireless Information

    Chapter Wireless Information System Characteristics The L100 Go System communicates wirelessly between components. Industry-standard Bluetooth Low Energy (BLE) 4.1 ® Description communication protocol Operating Frequency Band 2.4 Ghz, ISM band (2402-2480 MHz) Type of Modulation Type of Modulating Signal Binary data message Data Rate [=Frequency 250 Kbps of Modulating Signal]...

  • Page 61: Electromagnetic Compatibility (Emc) Information

    L100 Go System is not susceptible to the wide range of expected EMI emitters, such as Electronic Article Surveillance Systems (EAS), Radio Frequency Identification Systems (RFID), Tag Deactivators, and Metal Detectors. However, there is no guarantee that interference will not occur in a particular situation. Caution: If performance of the L100 Go System is affected by other equipment, the user should turn the L100 Go System off, and move away from the interfering equipment.
  • Page 62 Guidance and Manufacturer’s Declaration— Electromagnetic Immunity for All Equipment and Systems The L100 Go System is intended for use in the electromagnetic environment specified below. The customer or the user of the L100 Go System should assure that it is used in such an environment.
  • Page 63 Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment— Guidance Voltage dips, short <5% UT (>95% dip <5% UT (>95% dip Mains power interruptions, and in UT) for 0.5 cycle in UT) for 0.5 cycle quality should be voltage variations that of a typical on power supply 40% UT (60% dip...
  • Page 64 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The L100 Go System is intended for use in the electromagnetic environment specified below. The customer or the user of the L100 Go System should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic...
  • Page 65 NOTE 3: P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). NOTE 4: Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
  • Page 66 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the L100 Go System The L100 Go System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the L100 Go System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the L100 Go System as recommended below, according to the...

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