Bioness Neuromodulation A Bioness L3P-N-CU-V20 L300 Plus Control Unit User Manual User manual 21179

Bioness Neuromodulation ltd. A Bioness Inc Company L300 Plus Control Unit User manual 21179

manual part 1

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.com602-00382-001 Rev. BManufactured by Bioness Neuromodulation Ltd. A Bioness Inc Company19 Ha’Haroshet StreetPO Box 2500Industrial ZoneRa’Anana 43654, IsraelWorldwide Corporate Office Bioness Inc25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800-211-9136 Email: info@bioness.comWebsite: www.bioness.comRx Only
User’s Guide
IUser’s GuideRx Only
II User's GuideUser’s Guide Copyright© 2011, Bioness IncAll Rights ReservedNo 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.TrademarksNESS®, 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 Use of the symbol ® herein refers to the registration status of trademarks in the U.S. only. These trademarks may also be registered in other countries.Patents PendingAspects of this device are covered by several patents and patent applications, including US Pat 7,899,556.Disclaimer Bioness Inc and its affiliates shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc products. Bioness Inc does not accept any responsibility for any damage caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel.Environmental PolicyService personnel are advised that when changing any part of the NESS L300 Plus System, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. For more detailed information regarding these recommended procedures, please contact Bioness Inc. Bioness Inc is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines.Worldwide Corporate OfficeBioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USATelephone: 800-211-9136 Email: info@bioness.comWebsite: www.bioness.comManufactured by Bioness Neuromodulation Ltd. A Bioness Inc Company19 Ha’Haroshet StreetPO Box 2500Industrial ZoneRa’Anana 43654, IsraelBioness Client Relations Department: Telephone: (800) 211-9136, Option 2; or (661) 362-4850, Option 2.
IIIContentsList of Symbols ................................................................................................. VIIChapter 1: Introduction ........................................................................ 1Chapter 2: Device Description and Safety Information .................... 3Device Description ............................................................................................ 3Indications for Use ............................................................................................ 4Contraindications .............................................................................................. 4Warnings .......................................................................................................... 5Precautions ....................................................................................................... 5Adverse Reactions ........................................................................................... 9Skin Care Guidelines ........................................................................................ 9Chapter 3: Environmental Conditions that Affect Use ...................... 11Radio Frequency (RF) Communication Information ......................................... 11Travel and Airport Security ............................................................................... 12Electromagnetic Emissions .............................................................................. 13Warnings ..................................................................................................... 13Chapter 4: NESS L300 Plus System Kits ............................................ 15NESS L300 Plus System Kit ............................................................................. 15System Components .................................................................................. 15Accessories ................................................................................................ 15NESS L300 Plus System Upgrade Kit .............................................................. 18System Components .................................................................................. 18Accessories ................................................................................................ 18Chapter 5: NESS L300 Plus System ................................................... 19L300 Functional Stimulation (FS) Cuff ............................................................. 19Locator ........................................................................................................ 20Cradle ......................................................................................................... 20
IV User's GuideStrap ........................................................................................................... 20L300 Electrodes and Electrode Bases ....................................................... 20L300 RF Stim Unit ...................................................................................... 21Thigh FS Cuff .................................................................................................. 23Panels ......................................................................................................... 24Elongation Bar ............................................................................................ 24Locator ........................................................................................................ 24Cradle ......................................................................................................... 24Thigh Cloth Electrodes ............................................................................... 25Thigh RF Stim Unit ..................................................................................... 26Intelli-Sense Gait Sensor .................................................................................. 28L300 Plus Control Unit ...................................................................................... 30Operating Modes ........................................................................................ 32Standby Mode ....................................................................................... 32Gait Mode ............................................................................................. 32Training Mode ....................................................................................... 32Digital Display and Indicator Lights ............................................................ 33Audio Indicators .......................................................................................... 38Chapter 6: L300 Plus Accessories ...................................................... 39L300 Electrodes and Bases .............................................................................. 39Large Cloth Electrode ................................................................................. 40L300 Hydrogel Electrodes and Bases ........................................................ 43L300 Cloth Electrodes and Bases .............................................................. 47Thigh Cloth Electrodes ..................................................................................... 51Thigh Electrode Marking Ring .......................................................................... 55Cloth Electrode Mesh Bag ................................................................................ 56Thigh Elongation Bar Lock ............................................................................... 57
VControl Unit Wrist Strap, Neck Strap, and Belt Pouch ...................................... 58System Charger Set ......................................................................................... 59Replacement Battery, Gait Sensor ................................................................... 60Gait Sensor Pads ............................................................................................. 61Shoe Spacers ................................................................................................... 62Chapter 7: Setting Up the NESS L300 Plus System .......................... 63Preparing the Skin ............................................................................................ 63Checking the Components ............................................................................... 63Putting on the L300 FS Cuff ............................................................................. 64Testing the Position of the L300 FS Cuff .................................................... 68Putting on the Thigh FS Cuff ............................................................................ 69Testing the Position of the Thigh FS Cuff ................................................... 71Placing the Intelli-Sense Gait Sensor in the Shoe ............................................ 72Transferring the Intelli-Sense Gait Sensor to Another Shoe ....................... 76Using Multiple Intelli-Sense Gait Sensors .................................................. 76Chapter 8: Operating the NESS L300 Plus System ........................... 77Turning On/Off the NESS L300 Plus System ................................................... 77Testing the Position of the FS Cuffs ................................................................. 78L300 FS Cuff............................................................................................... 78Thigh FS Cuff.............................................................................................. 78Selecting an Operating Mode ........................................................................... 79Selecting Gait Mode ................................................................................... 79Selecting Training Mode ............................................................................. 79Returning to Standby Mode ........................................................................ 80Adjusting Stimulation Intensity .......................................................................... 81L300 FS Cuff............................................................................................... 81
VI User's GuideAdjustment Guidelines ................................................................................ 82Thigh FS Cuff.............................................................................................. 83Turning on Audio Feedback During Stimulation ............................................... 84L300 FS Cuff............................................................................................... 84Thigh FS Cuff.............................................................................................. 85Muting/Un-Muting the L300 Plus Control Unit .................................................. 86Turning Off Audio/Visual Alerts ......................................................................... 87L300 FS Cuff............................................................................................... 87Thigh FS Cuff.............................................................................................. 87Chapter 9: Maintenance and Cleaning ............................................... 89Daily Maintenance ............................................................................................ 89Charging the Batteries ...................................................................................... 90Battery Replacement ........................................................................................ 95Bases ................................................................................................................ 100L300 FS Cuff Strap ........................................................................................... 103Thigh Silicone Panels ....................................................................................... 104Removing the L300 and Thigh RF Stim Units .................................................. 107Cleaning the L300 Plus Components ............................................................... 108Disinfecting the L300 Plus Components ........................................................... 109Chapter 10: Electronic Registration ................................................... 111Chapter 11: Troubleshooting ............................................................... 117Chapter 12: Technical Specifications ................................................. 125Chapter 13: Appendix - EMI Tables ..................................................... 135
VIIList of SymbolsCaution or WarningDouble Insulated (Equivalent to Class II of IEC 536)Type BF Applied Part(s)Non-Ionizing RadiationDate of ManufactureManufacturerThis Product Must not be Disposed of with Other Household WasteConsult Instructions for UseSerial NumberRe-Order NumberLot NumberComplies with United States and Canadian Product Safety StandardsComplies with the European Union Medical Device DirectiveSingle Patient Use
VIII User's Guide
1Chapter 1 - Introduction1IntroductionCentral 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.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.This NESS L300 Plus User’s Guide describes: xImportant safety information about the NESS L300 Plus System. xThe components of the NESS L300 Plus System. xHow to set up, operate, and maintain the NESS L300 Plus System. xTroubleshooting information.Be sure to review this guide with your clinician before using the NESS L300 Plus System. If you have clinical or technical questions, consult your clinician or the Bioness Client Relations Department at (800) 211-9136, Option 3, or visit the Bioness website: www.bioness.com.CAUTION: Do not put on or operate the NESS L300 Plus System before being properly fitted and trained by a certified clinician.
2User's Guide
3Chapter 2 - Device Description and Safety Information2Device Description and Safety InformationDevice DescriptionThe NESS L300 Plus System consists of four main components: xL300 Functional Stimulation (FS) Cuff with L300 Radio Frequency (RF) Stim Unit—used to stimulate the nerves that control the muscles of the lower leg. xThigh FS Cuff with Thigh RF Stim Unit—used to stimulate the nerves that control the muscles of the thigh. xIntelli-Sense Gait Sensor—used to sense and wirelessly transmit heel events in the affected leg. xL300 Plus Control Unit—used to wirelessly control and monitor the NESS L300 Plus System.These components communicate wirelessly to provide synchronized ankle dorsiflexion and knee flexion or extension.
4User's GuideIndications for UseThe 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: xFacilitate muscle re-education. xPrevent or retard disuse atrophy. xMaintain or increase joint range of motion. xIncrease local blood flow.Contraindications xPatients with a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant should not use the NESS L300 Plus System. xThe NESS L300 Plus System should not be used on a leg where a cancerous lesion is present or suspected. xThe NESS L300 Plus System should not be used on a leg with a regional disorder, such as a fracture or dislocation, which could be adversely affected by motion from the stimulation.
5Chapter 2 - Device Description and Safety InformationWarnings xThe long-term effects of chronic electrical stimulation are unknown. xThe 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. xSimultaneous 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. xThe NESS L300 Plus System should only be configured by an authorized clinician.Precautions xInflammation in the region of the L300 and Thigh FS Cuffs may be aggravated by motion, muscle activity, or pressure from the FS Cuffs. Stop using the NESS L300 Plus System until any inflammation is gone. xUse caution if you have a suspected or diagnosed heart problem. xUse caution if you have suspected or diagnosed epilepsy. xUse the L300 and Thigh FS Cuffs with caution: xIf you have a tendency to bleed heavily following acute trauma or fracture. xFollowing recent surgical procedures when muscle contraction may disrupt the healing process. xOver areas of the skin that lack normal sensation.
6User's Guide xObtain 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). xObtain physician clearance before stimulating an area with a structural deformity. xThe safe use of the NESS L300 Plus System during pregnancy has not been established. xKeep the NESS L300 Plus System out of the reach of children. xThe L300 and Thigh FS Cuffs are to be worn only on the leg of the patient for whom they have been fitted. They should not be worn by anyone else or on any other part of the body. xSkin problems where the L300 and Thigh FS Cuffs are worn may be aggravated by the NESS L300 Plus System. xSome patients may experience a skin irritation, an allergic reaction, or hypersensitivity to the electrical stimulation or the electrical conductive medium. In some cases, irritation may be avoided by having your clinician change the stimulation parameters, type of electrodes used, or electrode placement. xAfter removing the L300 and Thigh FS Cuffs, it is normal for the areas under the electrodes to be red and indented. The redness should disappear in approximately one hour. Persistent redness, lesions, or blisters are signs of irritation. Stop using the NESS L300 Plus System until any irritation is gone.
7Chapter 2 - Device Description and Safety Information xDo not use the NESS L300 Plus System without electrodes. xUse only electrodes supplied by Bioness Inc. xChange the electrodes at least every two weeks. xOnly the treating clinician should determine electrode placement and stimulation settings. xTurn off the NESS L300 Plus System before removing, replacing, and wetting the electrodes. xTurn off the NESS L300 Plus System before putting on the L300 and Thigh FS Cuffs. Do not turn on the NESS L300 Plus System until the FS Cuffs are fastened in place. xTurn off the NESS L300 Plus System before driving, operating machinery, or performing any activity in which involuntary muscle contractions could injure you. xTurn off the NESS L300 Plus System when at a refueling place. Do not use the NESS L300 Plus System near flammable fuel, fumes, or chemicals. xStop using the NESS L300 Plus System and consult your clinician if stimulation does not start at the correct time during gait. xProtect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, snow, etc. xDo not leave the NESS L300 Plus 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. xThe NESS L300 Plus System needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual. See Chapter 3 and the Appendix.
8User's Guide xDo 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).CAUTION: Do not use the Intelli-Sense Gait Sensor with a rigid insole, such as a custom rigid orthosis or an ankle foot orthosis.
9Chapter 2 - Device Description and Safety InformationAdverse ReactionsIn the unlikely event that any of the following occurs, stop using your NESS L300 Plus System immediately and consult your physician: xSigns of significant irritation or pressure sores where the L300 and/or Thigh FS Cuffs contact the skin. xA significant increase in muscle spasticity. xA feeling of heart-related stress during stimulation. xSwelling of the leg, knee, ankle, or foot. xAny other unanticipated reaction.Skin irritations and burns have been reported with the use of powered muscle stimulators.Skin Care GuidelinesIn the absence of proper skin care, extended use of electrical stimulation may cause skin irritation or a skin reaction to the NESS L300 Plus System electrodes or the L300 and/or Thigh FS Cuffs. To promote healthy skin with long-term use of the NESS L300 Plus System, it is important to follow a daily skin-care routine: xClean the skin where the electrodes touch with a wet washcloth. If any oils or lotions are on the skin, then clean with soap and water. Rinse well. xAlways check the skin for redness or a rash when putting on and taking off the L300 and Thigh FS Cuffs. xWet the cloth electrodes before use and after every three to four hours of use.
10 User's Guide xReplace the electrodes at least every two weeks, even if they appear to be in good condition. xStore the L300 hydrogel electrodes with the protective plastic covers attached. Do not allow the hydrogel electrodes to dry. xStore the cloth electrodes where they can air dry. xExcess 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. A razor can irritate the skin. xWhen positioning the L300 and Thigh FS Cuffs, make sure the electrodes uniformly contact the skin. xVentilate the skin by removing the L300 and Thigh FS Cuffs for at least 15 minutes every 3 to 4 hours.If skin irritation or a skin reaction occurs, stop using your NESS L300 Plus System immediately. Contact your clinician or dermatologist, and the Bioness Client Relations Department, Option 3. Resume use only when the skin is completely healed. Then follow a skin conditioning protocol per the recommendation of your health-care specialist.If you have any questions or concerns, please call the Bioness Client Relations Department at (800) 211-9136, Option 3.
11Chapter 3 - Environmental Conditions that Affect Use3Environmental Conditions that Affect UseRadio Frequency (RF) Communication InformationSeveral 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. This equipment generates, uses, and can radiate RF energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: xReorient or relocate the receiving antenna. xIncrease the separation between the equipment and receiver. xConsult the dealer or an experienced radio/TV technician for assistance.The antenna for each transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.Portable and mobile RF communications equipment can affect the NESS L300 Plus System.
13Chapter 3 - Environmental Conditions that Affect UseElectromagnetic EmissionsThe 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: xDC power supply as provided by Bioness Inc, manufactured by FRIWO, Part No. FW7555M/05. xW cable (3-way splitter) as provided by Bioness Inc, Model No. L3P-5A00. Manufactured by Tamuz Electronics Ltd.Warnings xDo not use the NESS L300 Plus System within three feet of shortwave or microwave therapy equipment. Such equipment may produce instability in the output of the L300 and Thigh RF Stim Units. xRemove the NESS L300 Plus System before undergoing any diagnostic or therapeutic medical procedure such as x-ray examination, ultrasound, Magnetic Resonance Imaging (MRI), etc. xThe NESS L300 Plus System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. xThe use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the NESS L300 Plus System as replacement parts for internal components, may result in increased emissions or decreased immunity of the NESS L300 Plus System.
14 User's Guide xThe 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. xThe 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.

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