Bioness Neuromodulation A Bioness L3P-T-RFS-V10 Thigh RF Stimulation Unit User Manual manual1

Bioness Neuromodulation ltd. A Bioness Inc Company Thigh RF Stimulation Unit manual1

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manual1

NESS L300 Plus SystemUser’s GuideRx Only
IINESS L300 PlusUser’s Guide Copyright© 2010, 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 OnlyUse of the symbols ® and ™ 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.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, 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 Inc25103 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 Customer Support: Telephone: (800) 211-9136, Option 2; or (661) 362-4850, Option 2.
IIIContentsChapter 1: Introduction ........................................................................ 1Chapter 2: For Your Health and Safety ............................................... 3Indications for Use ............................................................................................ 3Contraindications .............................................................................................. 3Warnings .......................................................................................................... 4Precautions ....................................................................................................... 4Adverse Reactions ........................................................................................... 7Skin Care Guidelines ........................................................................................ 8Chapter 3: Environmental Conditions that Affect Use ...................... 11Radio Frequency (RF) Communication ............................................................ 11Conformity Certification .............................................................................. 12Travel ................................................................................................................ 12Chapter 4: Your NESS L300 Plus System Kit ..................................... 13Contents ........................................................................................................... 13System Components .................................................................................. 13L300 Accessories ....................................................................................... 14L300 Plus Accessories ............................................................................... 16L300 Plus Upgrade Kit ...................................................................................... 17Contents ..................................................................................................... 17Chapter 5: System Components and Accessories............................ 19L300 Functional Stimulation (FS) Cuff ............................................................. 19Locator ........................................................................................................ 20RF Stim Unit Cradle .................................................................................... 20Strap ........................................................................................................... 20Electrode Bases and Surface Electrodes .................................................. 20L300 RF Stim Unit ............................................................................................ 21
IVNESS L300 PlusThigh FS Cuff .................................................................................................. 23Distal and Proximal Panels ......................................................................... 24Elongation Bar ............................................................................................ 24Straps ......................................................................................................... 24Surface Electrodes ..................................................................................... 24Thigh RF Stim Unit ........................................................................................... 25Gait Sensor ....................................................................................................... 27L300 Plus Control Unit ...................................................................................... 29Control Unit Operating Buttons ................................................................... 30Control Unit Operating Modes .................................................................... 30Control Unit Digital Display and Indicator Lights ........................................ 32Control Unit Audio Indicators ...................................................................... 34L300 Accessories ............................................................................................. 35L300 Hydrogel Electrodes .......................................................................... 35L300 Hydrogel Electrode Bases ................................................................. 36L300 Cloth Electrodes ................................................................................ 37L300 Cloth Electrode Bases ....................................................................... 38Wrist Strap, Neck Strap, and Belt Pouch .................................................... 39Replacement Battery, Gait Sensor ............................................................. 40Gait Sensor Pads ....................................................................................... 41Shoe Spacers ............................................................................................. 42Phillips Screwdriver .................................................................................... 42L300 Plus Accessories ..................................................................................... 43L300 Plus System Charger Set .................................................................. 43Thigh FS Cuff Distal Panel Subassembly, Large ........................................ 44Thigh FS Cuff Elongation Bar Lock Set ...................................................... 45Thigh FS Cuff Electrode Marking Ring Set ................................................. 46Thigh FS Cuff Cloth Electrodes .................................................................. 47Chapter 6: Putting On and Taking Off the FS Cuffs .......................... 49
VPreparing the Skin ............................................................................................ 49Checking and Wetting the Electrodes .............................................................. 49Positioning the L300 FS Cuff ............................................................................ 50Removing the L300 FS Cuff ............................................................................. 54Positioning the Thigh FS Cuff on the Quadriceps ............................................ 55Positioning the Thigh FS Cuff on the Hamstrings ............................................. 60Removing the Thigh FS Cuff ............................................................................ 65Chapter 7: Placing the Gait Sensor in the Shoe ................................ 67Switching Shoes/Gait Sensors ......................................................................... 70Chapter 8: Operating the L300 Plus Control Unit .............................. 71RF Communication Safety Features ................................................................ 71Turning On/Off the Control Unit ........................................................................ 73Selecting an Operating Mode ........................................................................... 73Selecting Gait Mode ................................................................................... 73Selecting Training Mode ............................................................................. 73Returning to Standby Mode ........................................................................ 73Adjusting Stimulation Intensity .......................................................................... 74Adjusting the L300 RF Stim Unit ................................................................ 74Adjusting the Thigh RF Stim Unit ................................................................ 76Testing Stimulation ........................................................................................... 78Testing the L300 FS Cuff ............................................................................ 78Testing the Thigh FS Cuff ........................................................................... 78Turning on Audio Feedback During Stimulation ............................................... 79Turning on Audio Feedback for the L300 FS Cuff ...................................... 79Turning on Audio Feedback for the Thigh FS Cuff...................................... 79Muting the Audio Alerts ..................................................................................... 80Muting the Thigh RF Stim Unit Alerts ............................................................... 80
VINESS L300 PlusUser’s GuideChapter 9: Component Maintenance and Cleaning .......................... 81Charging the Batteries ...................................................................................... 81Replacing the Batteries .................................................................................... 86Replacing the RF Stim Unit Batteries ......................................................... 86Replacing the Gait Sensor Battery ............................................................. 86Replacing the L300 Plus Control Unit Battery ............................................ 87Replacing the L300 Hydrogel Electrodes ......................................................... 89Replacing the L300 Cloth Electrodes ............................................................... 92Replacing the L300 Electrode Bases ............................................................... 95Replacing the Thigh FS Cuff Cloth Electrodes ................................................. 98Removing the RF Stim Units ............................................................................ 101Inserting the RF Stim Units ............................................................................... 101Cleaning the System Components ................................................................... 102Chapter 10: Electronically Registering New Components ............... 103Registering a New L300 Plus Control Unit ....................................................... 103Registering a New RF Stim Unit ....................................................................... 106Registering a New Gait Sensor ........................................................................ 108Chapter 11: Troubleshooting ............................................................... 111Chapter 12: Component Technical Specifications ............................ 117
VIIList of SymbolsCautionDouble 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 UseRe-Order NumberLot Number
1Chapter 1 - Introduction1IntroductionCentral nervous system injuries often cause a gait disorder called foot drop and related muscle weakness in the thigh. 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. In addition, they may experience difficulty flexing or extending their knee.The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in people suffering from foot drop and thigh muscle weakness following an upper motor neuron injury or disease. The NESS L300 Plus System incorporates cutting-edge technology and sophisticated design features to improve gait and quality of life.The NESS L300 Plus System consists of four main components: •The NESS L300 Functional Stimulation (FS) Cuff with Radio Frequency (RF) Stimulation Unit for the lower leg •A Thigh FS Cuff with RF Stim Unit for the quadriceps or hamstrings •A Gait Sensor •An L300 Plus Control UnitThese components communicate wirelessly to send electrical pulses to the nerves that control the muscles of the lower leg and thigh. When stimulated at the appropriate phase of walking, the muscles raise the foot and extend or flex the knee, and may improve gait.
2NESS L300 PlusUser’s GuideFeatures of the NESS L300 Plus System include the following: •Each FS Cuff includes a cradle for the RF Stim Unit. •The FS Cuffs have an advanced ergonomic locator to ensure constant, snug contact with the leg. •The FS Cuffs can be put on with one hand and will easily fit under a loose pant leg. •The Gait Sensor detects when the foot is in the air and on the ground, and wirelessly regulates stimulation in both FS Cuffs accordingly. •The wireless handheld Control Unit monitors system status and manages system performance.This User’s Guide describes the NESS L300 Plus System and how to operate the system to achieve maximum benefits. It also describes important safety information, and maintenance and cleaning instructions. Be sure to review each section of this guide with your clinician before using your NESS L300 Plus System. If you have any questions, consult your clinician or Bioness Inc immediately.
3Chapter 2 - For Your Health and SafetyFor Your Health and SafetyIndications for UseThe NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals who have foot drop and thigh muscle weakness following an upper motor neuron injury or disease (such as a stroke, traumatic brain injury, multiple sclerosis, cerebral palsy, or incomplete spinal cord injuries).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: •Facilitate muscle re-education. •Prevent or retard disuse atrophy. •Maintain or increase joint range of motion. •Increase local blood flow.Contraindications •Patients with a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant should not use the NESS L300 Plus System. •The NESS L300 Plus System should not be used where a cancerous lesion is present or suspected.2
4NESS L300 PlusUser’s Guide •The NESS L300 Plus System should not be used on a leg where a regional disorder, such as a fracture or dislocation, could be adversely affected by motion from the stimulation.Warnings •The long-term effects of chronic electrical stimulation are unknown. •The NESS L300 Plus FS Cuffs should not be worn over swollen, infected, or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins. •Simultaneous connection of the NESS L300 Plus to the patient and high-frequency surgical equipment may result in skin burns where the stimulator electrodes adhere and damage to the RF Stim Units. •Do not use the NESS L300 Plus within three feet of shortwave or microwave therapy equipment. Such equipment may produce instability in the output of the RF Stim Units. •The NESS L300 Plus should only be configured by an authorized clinician.Precautions •Inflammation in the region of the NESS L300 Plus FS Cuffs may be aggravated by motion, muscle activity, or pressure from the FS Cuffs. Stop using the NESS L300 Plus until the inflammation is gone. •Use caution if you have a suspected or diagnosed heart problem. •Use the FS Cuffs with caution: •If you have a tendency to hemorrhage following acute trauma or fracture. •Following recent surgical procedures when muscle contraction may disrupt the healing process.
5Chapter 2 - For Your Health and Safety •Over areas of the skin that lack normal sensation. •If you have suspected or diagnosed epilepsy. •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. •Do not use the NESS L300 Plus without electrodes. •After removing the 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 until any irritation is gone. •Stop using the NESS L300 Plus and consult your clinician if stimulation does not start at the correct time during gait. •Do not wear the NESS L300 Plus during x-ray examinations. •Turn off the NESS L300 Plus when at a refueling place. Do not use the NESS L300 Plus near flammable fuel, fumes, or chemicals. •Only your treating clinician should determine electrode placement and stimulation settings. •Use only NESS L300 Plus electrodes supplied by Bioness Inc. •Obtain physician clearance prior to use if you have an alteration in normal arterial or venous flow in the region of the FS Cuffs because of local insufficiency, occlusion, arteriovenous fistula for hemodialysis, or a primary disorder of the vasculature. •Obtain physician clearance before stimulating an area with a structural deformity. •The safe use of the NESS L300 Plus during pregnancy has not been established.
6NESS L300 PlusUser’s Guide •Skin problems where the FS Cuffs are worn may be aggravated by the NESS L300 Plus. •Turn off the NESS L300 Plus before removing or replacing the electrodes. •Keep the NESS L300 Plus out of the reach of children. •The NESS L300 Plus Control Unit is splash proof. However, protect all electronic components from contact with water, such as from sinks, bathtubs, shower stalls, rain, snow, etc. •Do not leave the NESS L300 Plus stored where temperatures may exceed the acceptable environmental range: -20°C to +60°C (-4°F to +140°F). Temperature extremes can damage the components. •Do not attempt to repair your NESS L300 Plus. Contact Bioness if you experience a technical problem not covered in this guide. •The FS Cuffs are to be worn only on the leg of the patient for whom they are fitted. They should not be worn by anyone else or on any other part of the body. •Turn off the NESS L300 Plus before putting on the FS Cuffs. Do not turn on the NESS L300 Plus until the FS Cuffs are fastened in place. •Shut off the NESS L300 Plus before driving, operating machinery, or performing any activity in which involuntary muscle contractions could injure you. •Protect the NESS L300 Plus electronic components from condensation. When moving the components between hot and cold temperatures, place them in an airtight plastic bag, and let them slowly (for at least two hours) adjust to the temperature change before use. •Medical electrical equipment needs special precautions for electromagnetic compatibility.
7Chapter 2 - For Your Health and SafetyAdverse ReactionsIn the unlikely event that any of the following occurs, stop using your NESS L300 Plus immediately and consult your physician. •Signs of significant irritation or pressure sores where the FS Cuffs contact the skin. •A significant increase in muscle spasticity. •A feeling of heart-related stress during stimulation. •Swelling of the leg, knee, ankle, or foot. •Any other unanticipated reaction.Skin irritations and burns have been reported with the use of powered muscle stimulators.If you have any questions or concerns, please telephone the NESS L300 Plus Technical and Clinical Support Department at (800) 211-9136, Option 3.
8NESS L300 PlusUser’s GuideSkin Care GuidelinesIn the absence of proper skin care, extended use of electrical stimulation may cause skin irritation or a skin reaction to the electrodes or the FS Cuffs. Skin irritation tends to occur after approximately three months of use. To promote healthy skin with long-term use of the NESS L300 Plus, it is important to follow a daily skin-care routine. •Clean the skin where the electrodes adhere with a wet washcloth. If any oils or lotions are on the skin, then clean with soap and water. Rinse well. •Always check the skin for redness or a rash when putting on and taking off the FS Cuffs. •Replace the electrodes at least every two weeks, even if they appear to be in good condition. •After taking off the L300 FS Cuff, always re-cover hydrogel electrodes with the protective plastic covers. •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. Do not use a razor. A razor can irritate the skin. •When positioning the FS Cuffs, make sure the electrodes uniformly contact the skin. •Ventilate the skin by removing the FS Cuffs for at least 15 minutes every three to four hours.If skin irritation or a skin reaction occurs, stop using your NESS L300 Plus System immediately. Contact your clinician, dermatologist, or Bioness Clinical Specialist. Resume use only when the skin is completely healed. Then follow a skin conditioning protocol per the recommendation of your health-care specialist.
9Chapter 2 - For Your Health and SafetyIf you have any questions or concerns, please telephone the NESS L300 Plus Technical and Clinical Support Department at (800) 211-9136, Option 3.Caution: Do not put on or operate the NESS L300 Plus System before being properly fitted and trained by a certified clinician.Caution: The Gait Sensor has not been validated for use by individuals weighing more than 300 pounds (136 kilograms).Caution: Do not use the Gait Sensor with a rigid insole, such as a custom rigid orthosis or an ankle foot orthosis.Caution: Use only NESS L300 Plus electrodes supplied by Bioness Inc. Do not use the NESS L300 Plus System without electrodes.Caution: Change the electrodes every two weeks.Caution: 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.
10NESS L300 PlusUser’s Guide
11Chapter 3 - Environmental Conditions that Affect Use3Environmental Conditions that Affect UseRadio Frequency (RF) CommunicationSeveral 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: •Reorient or relocate the receiving antenna. •Increase the separation between the equipment and receiver.Consult 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 medical electrical equipment.
12NESS L300 PlusUser’s GuideConformity CertificationThe L300 Plus complies with Part 15 of the FCC rules. Operation is subject to the following two conditions:1. This device may not cause harmful interference, and2. This device must accept any interference received, including interference that may cause undesired operation.TravelThe NESS L300 Plus System charger set is compatible with both European and U.S. voltage: 110/220 V, 50/60 Hz. A voltage converter is not needed. A simple outlet adaptor should work. Outlet adaptors can be purchased at small electronic equipment stores.Turn off your NESS L300 Plus System before going through airport security. Wear loose clothing so that you can easily show the security person your NESS L300 Plus. The NESS L300 Plus System will likely set off the security alarm. Either ask for a “hand scan” or be prepared to remove your NESS L300 Plus so that security can scan it. You may want to carry a copy of your NESS L300 Plus prescription. A prescription can be useful when passing through customs as well.To request a copy of your prescription, call Bioness Customer Support: Telephone: (800) 211-9136, Option 2; or (661) 362-4850, Option 2. A Bioness representative can fax or mail you a copy. Note: The NESS L300 Plus System contains radio transmitters. The Federal Aviation Administration (FAA) rules require that all radio-transmitting devices be turned off during flight.
13Chapter 4 - Your NESS L300 Plus System KitYour NESS L300 Plus System KitYour NESS L300 Plus System includes components and accessories of the NESS L300 Foot Drop System plus a Thigh FS Cuff, Thigh RF Stim Unit, accessories for the Thigh FS Cuff, and a Control Unit. For individuals who already have a NESS L300 Foot Drop System, an L300 Plus System upgrade kit is provided.ContentsSystem Components •L300 FS Cuff with Strap, Right or Left •L300 RF Stim Unit •Thigh FS Cuff with Straps, Right or Left •Thigh RF Stim Unit •Gait Sensor •L300 Plus Control Unit4L300 Plus Control UnitL300 FS Cuffwith Strap and RF Stim UnitThigh FS Cuffwith Straps and RF Stim Unit Gait Sensor
14NESS L300 PlusUser’s GuideL300 Accessories •L300 Hydrogel Electrodes •L300 Hydrogel Electrode Bases •L300 Cloth Electrodes •L300 Cloth Electrode Bases •Control Unit Neck Strap •Control Unit Wrist Strap •Control Unit Belt Pouch •Replacement Battery, Gait Sensor •Gait Sensor Pads •Shoe Spacers •Phillips ScrewdriverHydrogel ElectrodeGait Sensor Battery
15Chapter 4 - Your NESS L300 Plus System KitCloth ElectrodeHydrogelElectrode BaseClothElectrode BaseWrist Strap Belt PouchNeck StrapShoe SpacersGait Sensor Pads Phillips Screwdriver
16NESS L300 PlusUser’s GuideL300 Plus Accessories •L300 Plus System Charger Set •Thigh FS Cuff Distal Panel Subassembly, Large •Thigh FS Cuff Elongation Bar Lock Set •Thigh FS Cuff Electrode Marking Ring Set •Thigh FS Cuff Cloth Electrodes •L300 Plus System Kit Carrying Case with Strap •NESS L300 Plus User’s Guide •NESS L300 Plus User's Instruction CardSystem Charger SetThigh FS Cuff Distal Panel SubassemblyThigh FS Cuff Cloth ElectrodesThigh FS Cuff Elongation Bar Lock SetThigh FS Cuff Electrode Marking Ring Set
17Chapter 5 - System Components and AccessoriesL300 Plus Upgrade KitFor individuals who already have a NESS L300 Foot Drop System, an L300 Plus System upgrade kit is provided.Contents •Thigh FS Cuff with Straps, Right or Left •Thigh RF Stim Unit •L300 Plus Control Unit •L300 Plus System Charger Set •Thigh FS Cuff Distal Panel Subassembly, Large •Thigh FS Cuff Elongation Bar Lock Set •Thigh FS Cuff Electrode Marking Ring Set •Thigh FS Cuff Cloth Electrodes •L300 Plus System Kit Carrying Case with Strap •Replacement Battery, Gait Sensor •Control Unit Neck Strap •Control Unit Wrist Strap •Control Unit Belt Pouch •NESS L300 Plus User’s Guide •NESS L300 Plus User's Instruction Card
18NESS L300 PlusUser’s Guide
19Chapter 5 - System Components and Accessories5System Components and AccessoriesThis section describes the components and accessories of the L300 Plus System.L300 Functional Stimulation (FS) Cuff The L300 FS Cuff is an ergonomic orthosis that fits on the leg below the knee. The L300 FS Cuff is designed to facilitate dorsiflexion of the foot. It is lightweight, easy to put on with one hand, and can be worn under loose clothing. An ergonomic locator on the L300 FS Cuff ensures accurate and repeatable positioning of the surface electrodes on the lower leg. See Figure 1.Figure 1: The L300 FS Cuff (right configuration) and L300 RF Stim Unit.LinerElectrode LocatorFlexible Strap HandleCradle for the RF Stim UnitStatus LightStimulation LightL300 RF Stim UnitAdjustable Strap
20NESS L300 PlusUser’s GuideThe L300 FS Cuff is available in right and left configurations. It is designed to house an integrated L300 RF Stim Unit and two surface electrodes. The RF Stim Unit produces the stimulation signal. The surface electrodes deliver the stimulation signal from the RF Stim Unit to the leg. Both hydrogel and cloth surface electrodes and electrode bases are provided.LocatorThe L300 FS Cuff features an ergonomic locator for accurate and repeatable positioning of the surface electrodes. The locator forms a "V" and is placed just under the kneecap.RF Stim Unit CradleThe L300 FS Cuff includes a cradle for the L300 RF Stim Unit. The RF Stim Unit snaps in and out of the cradle, and is removed for maintenance and cleaning.StrapThe strap on the L300 Plus FS Cuff is adjustable and features a flexible strap handle. Three strap sizes are available: small, medium, and large. The strap can be removed and is replaceable.Electrode Bases and Surface Electrodes The L300 FS Cuff uses two surface electrodes to stimulate the skin. The surface electrodes attach to two electrode bases, which connect to the FS Cuff liner. During your fitting session, your clinician will determine the best position for the electrode bases and electrodes on the L300 FS Cuff.
21Chapter 5 - System Components and AccessoriesL300 RF Stim UnitThe L300 RF Stim Unit generates the electrical stimulation pulses used to dorsiflex the foot. The L300 RF Stim Unit responds to wireless signals from the L300 Plus Control Unit and the Gait Sensor to turn stimulation on/off. Features include a rechargeable battery, a status light, and a stimulation light. See Table 1. Display Description DefinitionStatus LightFlashes GREEN System is OnFlashes YELLOW Low BatteryAlternately Flashes YELLOW and GREENBattery ChargingSolid GREEN Battery Fully ChargedFlashes RED Radio Communication FailureSolid RED RF Stim Unit MalfunctionStimulation Light Flashes YELLOW SLOWLY Stimulation is OffFlashes YELLOW RAPIDLY Stimulation is OnTable 1: L300 RF Stim Unit displays and definitions.
22NESS L300 PlusUser’s GuideRF Stim Unit CradleL300 FS CuffL300 RF Stim UnitFigure 2: Removing the L300 RF Stim Unit.The L300 RF Stim Unit emits both visual and audio alerts when radio communication fails or the component malfunctions.The L300 RF Stim Unit snaps in and out of the cradle of the L300 FS Cuff. See Figure 2. The L300 RF Stim Unit should only be removed from the cradle for maintenance and when cleaning the L300 FS Cuff.
23Chapter 5 - System Components and AccessoriesThigh FS Cuff The Thigh FS Cuff is an ergonomic orthosis that fits over the hamstrings or quadriceps muscles. The Thigh FS Cuff is designed to be used in unison with the L300 FS Cuff, to assist with knee flexion or extension throughout the gait cycle. See Figure 3.The Thigh FS Cuff is available in right and left configurations, and houses an integrated Thigh RF Stim Unit and two surface electrodes. The Thigh RF Stim Unit produces the stimulation signal. The electrodes deliver the stimulation signal from the Thigh RF Stim Unit to the hamstrings or quadriceps muscles.Figure 3: The Thigh FS Cuff.RF Stim Unit CradleThigh FS CuffThigh RF Stim UnitCaution: The FS Cuffs should be removed from the skin every three to four hours for 15 minutes to allow the skin to breathe.
24NESS L300 PlusUser’s GuideDistal and Proximal PanelsThe Thigh FS Cuff features two panels: a distal panel that is positioned closer to the knee and a proximal panel that is positioned farther from the knee. The distal panel features a cradle for the Thigh RF Stim Unit. The L300 Plus System Kit includes a replacement large distal panel that fits a larger leg circumference, if needed.Elongation BarConnecting the distal and proximal panels is an elongation bar. The elongation bar is used to adjust the distance between the distal and proximal panels. (Your clinician will determine the distance most appropriate for you and adjust the elongation bar accordingly.) The elongation bar features a locator arrow used to position the Thigh FS Cuff on the leg.StrapsThe distal and proximal panels each feature two straps used to secure the Thigh FS Cuff on the leg. The straps are adjustable and can be fastened with one hand. The straps are also washable and replaceable.Surface ElectrodesThe Thigh FS Cuff features two cloth electrodes. One electrode attaches to the distal panel. One attaches to the proximal panel. During your fitting session, your clinician will fit the electrodes to the Thigh FS Cuff. Afterward, you will need to replace the electrodes every two weeks.
25Chapter 5 - System Components and AccessoriesRF Stim Unit CradleThigh FS CuffThigh RF Stim UnitThigh RF Stim UnitThe Thigh RF Stim Unit snaps in and out of the cradle of the Thigh FS Cuff. See Figure 4. The Thigh RF Stim Unit generates the electrical stimulation pulses used to extend the quadriceps muscles or flex the hamstrings muscles.The Thigh RF Stim Unit responds to wireless signals from the L300 Plus Control Unit and the Gait Sensor to turn stimulation on/off. It has a rechargeable battery, a status light, and a stimulation light. See Table 2.Figure 4: Removing the Thigh RF Stim Unit.
26NESS L300 PlusUser’s GuideDisplay Description DefinitionStatus Light Flashes GREEN System is OnFlashes YELLOW Low BatteryAlternately Flashes YELLOW and GREENBattery ChargingSolid GREEN Battery Fully ChargedFlashes RED Radio Communication FailureSolid RED RF Stim Unit MalfunctionStim Light Flashes YELLOW SLOWLYStimulation is OffFlashes YELLOW RAPIDLYStimulation is On Table 2: Thigh RF Stim Unit displays and definitions.The Thigh RF Stim Unit emits both visual and audio alerts when radio communication fails or the component malfunctions.The Thigh RF Stim Unit should be removed from the cradle for maintenance and when cleaning the Thigh FS Cuff.
27Chapter 5 - System Components and AccessoriesGait SensorThe Gait Sensor consists of a pressure sensor and a transmitter. See Figure 5. The pressure sensor is used to detect when your foot is in the air and on the ground. The transmitter is used to signal the L300 RF Stim Unit and the Thigh RF Stim Unit to move your foot and knee accordingly. The Gait Sensor communicates wirelessly with the L300 RF Stim Unit and the Thigh RF Stim Unit.Figure 5: NESS L300 Gait Sensor.ClampTransmitterPressure Sensor
28NESS L300 PlusUser’s GuideFigure 6: Gait Sensor placed in a left shoe.The pressure sensor fits under the insole of the shoe of the affected leg, attached to a Gait Sensor pad. See Figure 6. The transmitter is worn clamped to the inner rim of the shoe. Shoe spacers are provided to protect the shoe from damage from the clamp.The Gait Sensor can be transferred to a different shoe, or additional sensors can be purchased for different shoes. You do not need to detach the Gait Sensor between uses.The Gait Sensor is powered by a small non-rechargeable battery. The battery will need to be replaced after approximately six months of use. The L300 Plus System Kit includes a replacement battery and a Phillips screwdriver for changing the battery.Caution: The Gait Sensor has not been validated for use by individuals weighing more than 300 pounds (136 kilograms).
29Chapter 5 - System Components and AccessoriesL300 Plus Control UnitThe L300 Plus Control Unit is used to turn on/off the L300 Plus System, select an operating mode (gait, training, standby, or clinician), fine-tune stimulation intensity, mute audio alerts, test stimulation intensity of the individual RF Stim Units, and monitor system performance. See Figure 7. The Control Unit communicates wirelessly with the L300 RF Stim Unit, the Thigh RF Stim Unit, and the Gait Sensor. It is powered by a single rechargeable AAA battery. It is also small enough to be worn around the neck or wrist, or carried in a pocket or belt pouch.Figure 7: Control Unit operating buttons and digital display.On/Off ButtonLoop Hole for Wrist and Neck StrapsMode Button Intensity Adjustment (Plus/Minus)ButtonsDigital DisplayMute Button RF Stim Unit Selection Buttons Stimulation Test Button
30NESS L300 PlusUser’s GuideYour L300 Plus System Kit includes a system charger set for charging the Control Unit, the L300 RF Stim Unit, and the Thigh RF Stim Unit. It also includes a belt pouch, wrist strap, and neck strap for carrying the Control Unit. A Phillips screwdriver is provided for changing the Control Unit battery.Control Unit Operating ButtonsThe Control Unit operating buttons and their functions are described in Table 3.Control Unit Operating ModesThe Control Unit has four operating modes: standby, gait, training, and clinician. Only clinicians use clinician mode.Standby ModeIn standby mode, the L300 Plus System is on and waiting for commands. Stimulation is off.Gait ModeGait mode is used when walking. In gait mode, the Gait Sensor signals the L300 and Thigh RF Stim Units when your heel leaves the ground, turning stimulation on. It also signals when your heel contacts the ground, turning stimulation off.Training ModeTraining mode is used to train muscles when you are not walking (for example, sitting or lying down). Training mode should not be used when walking. Training mode works independently of the Gait Sensor. Stimulation is delivered in cycles pre-set by your clinician. Training mode is designed to facilitate
31Chapter 5 - System Components and AccessoriesControl UnitOperating Button Description FunctionOn/Off Turns On/Off the Control UnitMode Selects Standby, Gait, Training, or Clinician ModeIntensity Adjustment(Plus/Minus)Adjusts Stimulation Intensity LevelRF Stim Unit Selection"Up" Button Selects the Thigh RF Stim Unit "Down" Button Selects the L300 RF Stim UnitMuteMutes the Audio Indicators; Selects Single Component ModeStimulation TestTests Stimulation for the Selected RF Stim Unit (Functional Only in Standby Mode)Table 3: Control Unit operating buttons and functions.
32NESS L300 PlusUser’s GuideIntelli-Sense Gait Sensor Indicator L300 RF Stim Unit Indicator Control Unit Indicator Thigh RF Stim Unit Indicator RF Communication Error IndicatorFigure 8: Control Unit digital display and indicators.muscle re-education, prevent or retard disuse atrophy of the lower leg and thigh muscles, maintain or improve range of motion of the ankle and knee joints, and improve local blood circulation.Control Unit Digital Display and Indicator LightsThe Control Unit digital display and indicator lights indicate stimulation intensity level, operating mode, battery charge status, electronic registration status, and error messages. See Figure 8 and tables 4 and 5.
33Chapter 5 - System Components and AccessoriesDisplay Description DefinitionOn/Off Button Flashes GREEN System is On Mode Button Flashes YELLOW SLOWLYSystem is in Gait/Training/Clinician Mode, Stimulation is OffMode Button Flashes YELLOW RAPIDLYSystem is in Gait/Training/Clinician Mode, Stimulation is OnDisplays 0–9 Intensity Level Intensity Level and “t” Alternate System is in Training ModeA Component Indicator Flashes YELLOW Component Low BatteryTop Arrow and Thigh RF Stim Unit Indicator are GREEN Thigh RF Stim Unit SelectedBottom Arrow and L300 RF Stim Unit Indicator are GREEN L300 RF Stim Unit SelectedRotating GREEN Circle Control Unit ChargingHorizontal GREEN Line Control Unit Fully ChargedTable 4: Control Unit visual displays and definitions.
34NESS L300 PlusUser’s GuideDisplay Description DefinitionThigh RF Stim Unit Indicator Flashes RED Faulty Electrode ContactControl Unit and RF Stim Unit Indicators Alternately Flash RED and “E” FlashesRadio Communication Failure Between the Control Unit and RF Stim UnitGait Sensor and RF Stim Unit Indicators Alternately Flash REDGait Sensor Hibernation or Radio Communication Failure between the Gait Sensor and RF Stim UnitA Component Indicator is Solid RED Component MalfunctionTable 4: Control Unit error displays and definitions.Control Unit Audio IndicatorsThe Control Unit beeps to indicate: •The system is on. •A button was pressed. •Low battery. •An error (usually accompanied by a visual indicator).

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