NESS L300 Plus System User’s Guide Rx Only
NESS L300 Plus User’s Guide Copyright © 2010, 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 Chapter 1: Introduction......................................................................... Chapter 2: For Your Health and Safety................................................ 1 3 Indications for Use............................................................................................. Contraindications............................................................................................... Warnings................................................................................
NESS L300 Plus Thigh FS Cuff ................................................................................................... Distal and Proximal Panels.......................................................................... Elongation Bar............................................................................................. Straps.......................................................................................................... Surface Electrodes..........................................
Preparing the Skin............................................................................................. Checking and Wetting the Electrodes............................................................... Positioning the L300 FS Cuff............................................................................. Removing the L300 FS Cuff.............................................................................. Positioning the Thigh FS Cuff on the Quadriceps............................................
NESS L300 Plus Chapter 9: Component Maintenance and Cleaning........................... 81 Charging the Batteries....................................................................................... 81 Replacing the Batteries..................................................................................... 86 Replacing the RF Stim Unit Batteries.......................................................... 86 Replacing the Gait Sensor Battery..............................................................
List of Symbols Caution 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 Re-Order Number Lot Number VII
1 Introduction Central 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.
NESS L300 Plus Features 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.
2 For Your Health and Safety Indications for Use The 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).
NESS L300 Plus •• 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.
•• •• •• •• •• •• •• •• •• •• •• •• 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.
NESS L300 Plus •• 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.
Adverse Reactions In 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.
NESS L300 Plus Skin Care Guidelines In 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.
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.
NESS L300 Plus 10 User’s Guide
Environmental Conditions that Affect Use Radio Frequency (RF) Communication 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.
NESS L300 Plus Conformity Certification The 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, and 2. This device must accept any interference received, including interference that may cause undesired operation. Travel The 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.
4 Your NESS L300 Plus System Kit Your 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.
NESS L300 Plus L300 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 Screwdriver Hydrogel Electrode Gait Sensor Battery 14 User’s Guide
Hydrogel Electrode Base Neck Strap Gait Sensor Pads Cloth Electrode Cloth Electrode Base Wrist Strap Belt Pouch Shoe Spacers Phillips Screwdriver Chapter 4 - Your NESS L300 Plus System Kit 15
NESS L300 Plus L300 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 Card System Charger Set Thigh FS Cuff Elongation Thigh FS Cuff Distal Panel Subassembly Bar Lock Set Thigh FS Cuff Electrode Thigh FS Cuff Cloth Elect
L300 Plus Upgrade Kit For individuals who already have a NESS L300 Foot Drop System, an L300 Plus System upgrade kit is provided.
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System Components and Accessories This 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.
NESS L300 Plus The 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. Locator The L300 FS Cuff features an ergonomic locator for accurate and repeatable positioning of the surface electrodes.
L300 RF Stim Unit The 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.
NESS L300 Plus 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. RF Stim Unit Cradle L300 FS Cuff L300 RF Stim Unit Figure 2: Removing the L300 RF Stim Unit.
Thigh 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.
NESS L300 Plus Distal and Proximal Panels The 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 Bar Connecting the distal and proximal panels is an elongation bar.
Thigh RF Stim Unit The 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.
NESS L300 Plus 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.
Gait Sensor The 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. Transmitter Clamp Pressure Sensor Figure 5: NESS L300 Gait Sensor.
NESS L300 Plus 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. Figure 6: Gait Sensor placed in a left shoe.
L300 Plus Control Unit The 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.
NESS L300 Plus Your 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 Buttons The Control Unit operating buttons and their functions are described in Table 3.
Control Unit Operating Button Description Function On/Off Turns On/Off the Control Unit Mode Selects Standby, Gait, Training, or Clinician Mode Intensity Adjustment (Plus/Minus) RF Stim Unit Selection Adjusts Stimulation Intensity Level "Up" Button Selects the Thigh RF Stim Unit "Down" Button Selects the L300 RF Stim Unit Mute Mutes the Audio Indicators; Selects Single Component Mode Stimulation Test Tests Stimulation for the Selected RF Stim Unit (Functional Only in Standby Mode) Table 3: Co
NESS L300 Plus 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 Lights The 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.
Display Description Definition On/Off Button Flashes GREEN System is On Mode Button Flashes YELLOW SLOWLY System is in Gait/Training/ Clinician Mode, Stimulation is Off Mode Button Flashes YELLOW RAPIDLY System is in Gait/Training/ Clinician Mode, Stimulation is On Displays 0–9 Intensity Level Intensity Level and “t” Alternate System is in Training Mode A Component Indicator Flashes YELLOW Component Low Battery Top Arrow and Thigh RF Stim Unit Indicator are GREEN Thigh RF Stim Unit Selected
NESS L300 Plus Display Description Definition Thigh RF Stim Unit Indicator Flashes RED Faulty Electrode Contact Control Unit and RF Stim Unit Indicators Alternately Flash RED and “E” Flashes Radio Communication Failure Between the Control Unit and RF Stim Unit Gait Sensor and RF Stim Unit Indicators Alternately Flash RED Gait Sensor Hibernation or Radio Communication Failure between the Gait Sensor and RF Stim Unit A Component Indicator is Solid RED Component Malfunction Table 4: Control Unit er
