Manufactured by Bioness Neuromodulation Ltd. A Bioness Inc Company 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800-211-9136 Email: info@bioness.com Website: www.bioness.com NESS®, NESS L300®, NESS L300® Plus, Intelli-Gait®, Intelli-Sense Gait Sensor®, Bioness, the Bioness Logo and LiveOn® are trademarks of Bioness Inc. | www.bioness.com Rx Only 602-00382-001 Rev.
User’s Guide
User’s Guide Rx Only I
User’s Guide Copyright © 2011, 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. Trademarks NESS®, NESS L300®, NESS L300® Plus, Intelli-Gait®, Intelli-Sense Gait Sensor®, Bioness®, the Bioness Logo and LiveOn® are trademarks of Bioness Inc. | www.bioness.
Contents List of Symbols ................................................................................................. VII Chapter 1: Introduction ........................................................................ Chapter 2: Device Description and Safety Information .................... 1 3 Device Description............................................................................................ Indications for Use ............................................................................
Strap ........................................................................................................... L300 Electrodes and Electrode Bases ....................................................... L300 RF Stim Unit ...................................................................................... Thigh FS Cuff .................................................................................................. Panels .................................................................................
Control Unit Wrist Strap, Neck Strap, and Belt Pouch...................................... System Charger Set ......................................................................................... Replacement Battery, Gait Sensor ................................................................... Gait Sensor Pads ............................................................................................. Shoe Spacers .......................................................................................
Adjustment Guidelines ................................................................................ Thigh FS Cuff.............................................................................................. Turning on Audio Feedback During Stimulation ............................................... L300 FS Cuff............................................................................................... Thigh FS Cuff.......................................................................................
List of Symbols Caution or 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 Consult Instructions for Use Serial Number Re-Order Number Lot Number Complies with United States and Canadian Product Safety Standards Complies with the European Union Medical Device Directive Single Patient Use VII
VIII User's Guide
1 Introduction Central nervous system (CNS) injuries and diseases 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. Many people with CNS injuries/diseases also suffer from thigh muscle weakness. Weak thigh muscles can cause considerable difficulties with flexing or extending the knee during ambulation.
2 User's Guide
2 Device Description and Safety Information Device Description The NESS L300 Plus System consists of four main components: x L300 Functional Stimulation (FS) Cuff with L300 Radio Frequency (RF) Stim Unit—used to stimulate the nerves that control the muscles of the lower leg. x Thigh FS Cuff with Thigh RF Stim Unit—used to stimulate the nerves that control the muscles of the thigh. x Intelli-Sense Gait Sensor—used to sense and wirelessly transmit heel events in the affected leg.
Indications for Use The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease. During gait, the NESS L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension; thus, it may improve the individual’s gait. The NESS L300 Plus System may also: x Facilitate muscle re-education.
Warnings x The long-term effects of chronic electrical stimulation are unknown. x The L300 and Thigh FS Cuffs should not be worn over swollen, infected, or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins. x Simultaneous connection of the NESS L300 Plus System to the patient and high-frequency surgical equipment may result in skin burns where the stimulator electrodes touch and damage to the L300 and Thigh RF Stim Units.
6 x Obtain physician clearance prior to use if you have an alteration in normal arterial or venous flow in the region of the L300 and/or Thigh FS Cuffs because of local insufficiency (insufficient blood flow), occlusion (a blood flow blockage), arteriovenous fistula for the purpose of hemodialysis (an abnormal connection between an artery and vein), or a primary disorder of the vasculature (a disease of the blood vessels: arteries, veins, and lymphatics).
x Do not use the NESS L300 Plus System without electrodes. x Use only electrodes supplied by Bioness Inc. x Change the electrodes at least every two weeks. x Only the treating clinician should determine electrode placement and stimulation settings. x Turn off the NESS L300 Plus System before removing, replacing, and wetting the electrodes. x Turn off the NESS L300 Plus System before putting on the L300 and Thigh FS Cuffs.
x Do not attempt to repair your NESS L300 Plus System. Changes or modifications to the NESS L300 Plus System components not expressly approved by Bioness Inc could void the user’s authority to operate the equipment. Contact the Bioness Client Relations Department, Option 3, if you experience a clinical or technical problem not covered in this guide. CAUTION: The Intelli-Sense Gait Sensor has not been validated for use by individuals weighing more than 300 pounds (136 kilograms).
Adverse Reactions In the unlikely event that any of the following occurs, stop using your NESS L300 Plus System immediately and consult your physician: x Signs of significant irritation or pressure sores where the L300 and/or Thigh FS Cuffs contact the skin. x A significant increase in muscle spasticity. x A feeling of heart-related stress during stimulation. x Swelling of the leg, knee, ankle, or foot. x Any other unanticipated reaction.
x Replace the electrodes at least every two weeks, even if they appear to be in good condition. x Store the L300 hydrogel electrodes with the protective plastic covers attached. Do not allow the hydrogel electrodes to dry. x Store the cloth electrodes where they can air dry. x Excess body hair where the L300 hydrogel electrodes adhere may reduce electrode contact with the skin. If necessary, remove excess body hair with an electric shaver or scissors. Do not use a razor.
3 Environmental Conditions that Affect Use Radio Frequency (RF) Communication Information Several components of the NESS L300 Plus 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
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Electromagnetic Emissions The NESS L300 Plus System needs special precautions regarding electromagnetic compatibility (EMC). The system needs to be installed and put into service according to the EMC information provided in this manual. See Appendix. The NESS L300 Plus System was tested and certified to use the following: x DC power supply as provided by Bioness Inc, manufactured by FRIWO, Part No. FW7555M/05. x W cable (3-way splitter) as provided by Bioness Inc, Model No. L3P-5A00.
14 x The use of the accessory, transducer, or cable with equipment and systems other than those specified may result in increased emissions or decreased immunity of the NESS L300 Plus System. x The NESS L300 Plus System may be interfered with by other equipment, even if that other equipment complies with CISPR (International Special Committee on Radio Interference, International Electrotechnical Commission) emission requirements.
