User's Guide Part No: B0001002 Rev 1
User Guide Copyright © 2006 NESS Ltd. 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 NESS Ltd. Trademarks NESS is a trademark of NESS Ltd. NESS L300™ is a trademark of NESS Ltd. Disclaimer NESS Ltd.
Contents 1. Introduction to your NESS L300™................................................ 1 Indications For Use........................................................................... 1 Advanced Technology in Rehabilitation............................................ 1 For Your Health and Safety............................................................... 2 2. General Overview of your NESS L300™.............................................. 7 Components of the NESS L300™..............................
Taking the Orthosis off....................................................................... 22 Operating the Control Unit.................................................................22 5. Care and Maintenance.................................................................... 25 Batteries............................................................................................ 25 Low Battery Warning........................................................................ 25 Charging the Batteries...
List of Figures Figure 1: NESS L300™ System Components .......................................7 Figure 2: The Orthosis ...........................................................................8 Figure 3: The Foot Sensor ...................................................................10 Figure 4: The Control Unit ................................................................... 11 Figure 5: Recommended Knee Angle for Orthosis Application ............
Figure 16: Removing a New Electrode from its Cover...........................32 Figure 17: Attaching a New Electrode ...................................................32 Figure 18: Removing the Protective Liners............................................33 Figure 19: Attaching the Electrode Cover ..............................................34 Figure 20: Display while Registering .....................................................38 Figure 21: Removing the RF Stim Unit from the Orthosis ...............
Introduction to your NESS L300 Chapter 1 TM Indications For Use The NESS L300™ is intended to provide ankle dorsiflexion in individuals with foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300™ electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual’s gait.
integrated electrodes. While walking, the Foot Sensor detects whether the foot is in the air or on the ground and transmits that information to the rest of the system which accordingly activates the foot. The wireless Control Unit displays information regarding the system's status and manages the various system components. The NESS L300TM system incorporates cutting edge technology and sophisticated ergonomics in order to improve your walking and quality of life.
Warnings • • The long-term effects of chronic electrical stimulation are unknown. The Orthosis should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc. • Simultaneous connection of the L300™ to the patient and to high-frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the RF Stim Unit of the Orthosis.
Caution should be used for patients with suspected or diagnosed epilepsy. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium or alternate electrode placement. • • • Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
• Do not leave the NESS L300™ stored in a car in hot weather where the temperature may exceed the recommended storage temperature and could cause damage to the device. • Should any technical problem occur, that is not covered in the troubleshooting section of this manual, contact your clinician or NESS L300™ distributor. Do not attempt to repair your NESS L300™. • The Orthosis is meant to be worn only on the leg of the user for whom it is fitted.
Radio Communication Information This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions: This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. Parts of the NESS L300™ 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 of the FCC Rules.
General Overview of your NESS L300 Chapter 2 TM Components of the NESS L300™ The NESS L300™ is supplied with the following components: • Control Unit • Orthosis & RF Stim Unit • Foot Sensor & Adhesive pads • Electrodes • Charger • User's Guide • Carrying case Control Unit Orthosis Foot Sensor Electrodes Charger User Guide Figure 1: NESS L300™ System Components Chapter 2 - General Overview of your NESS L300™ 7
The Orthosis Electrode Base Electrode Locator Strap Strap Handle RF Stim Unit Cradle Stimulation Light Status Light Figure 2: The Orthosis • The Orthosis is light weight and has a low profile allowing it to be positioned under trousers. • It is anatomically designed to allow accurate placement on the leg. • The RF Stim Unit is integrated into the cradle on the Orthosis. It may be snapped in or out of the Orthosis for maintenance.
• The device is held in place by a strap which may be fastened using only one hand. • Two electrodes are attached to their bases on the inner lining of the Orthosis; their position in the Orthosis has been carefully determined by the clinician during the fitting process. The electrodes may be easily replaced by the user without changing their positions. Indicator lights on the RF Stim Unit Indicator lights on the RF Stim Unit displays the unit's status and when stimulation occurs.
The Foot Sensor The Foot Sensor (Figure 3) detects whether the foot is on the ground or in the air and transmits radio signals to the RF Stim Unit according to which stimulation is activated. The Foot Sensor consists of a pressure sensor worn underneath the insole of the shoe and a small transmitter attached to the upper edge of the shoe by a clamp. There is no need to detach the Foot Sensor between uses.
The Control Unit The Control unit (see figure 4) enables the user to activate/deactivate the system, select the operation mode, fine-tune the stimulation intensity and receive information regarding the system by visual and audio indicators. During operation, the Control unit maintains communication with the RF Stim Unit in the Orthosis and Foot Sensor. It can be carried in a pocket, belt pouch or around the neck using the neck strap supplied. The Control Unit is powered by a single rechargeable AAA battery.
Control Unit Buttons Control Unit 12 User’s Guide Operating Button Description ON/OFF Turns the Control Unit ON and OFF Gait mode Selects Gait, Training or Standby Mode Volume Adjustment Adjusts the volume of the audio indications Intensity Adjusts the intensity of stimulation
Control Unit Display and Audio Indications Visual Indications Control Unit Display Display Pattern Description Flashes Green System is ON Flashes Yellow SLOWLY System in Gait or Training mode, but not Stimulating Flashes Yellow RAPIDLY System in Gait or Training mode and Stimulating Displays 0 - 9 Intensity level Alternates “t” and the intensity level Training mode One of the Indications Flashes Yellow Low Battery Rotating Circle Charging Horizontal Line Fully Charged Chapter 2 - General
Audio indications The audio alert beeps when: • The system is first turned ON. • A button is pressed. • Low battery. • There is a malfunction accompanied by a visual indication.
Chapter 3 Operating Modes Standby mode The system is ON, and waiting for commands. Stimulation is not applied in Standby mode. Gait mode Select this mode for walking. In Gait mode the stimulation is synchronized by the Foot Sensor, in order to achieve foot lifting while the foot is in the air and foot rest while the foot is on the ground. Training mode Select this mode for muscle training while you are sitting or lying down.
Daily Use of your NESS L300 TM Activating and Using the System 1. Position the Orthosis on your leg. 2. Turn ON the Control unit. 3. Select either GAIT or TRAINING mode. 4. Begin walking or let the training mode exercise your leg. Before using the system make sure the Foot Sensor is installed. If not install it according to the section “Placing the Foot Sensor in your Shoe”.
Positioning the Orthosis on your leg 1. While seated, slightly extend your leg as seen in Figure 5. This causes the outline of the kneecap to be clearly defined. It may be helpful to place your foot on a small stool or footrest. The point under your Kneecap where the Locator of the Orthosis Should fit.
2. Grasp the Orthosis around the cradle area and tilt it towards you, slide the Orthosis up your leg, until the "U" of the Locator reaches the lower part of the kneecap, as seen in Figure 6. Locator Strap Handle Figure 6: Placing the Orthosis on the Leg After the Orthosis is in position, push the Orthosis against the leg. The Orthosis will gently grip the leg.
3. To fasten the Orthosis strap, grasp the handle of the elastic strap with the fingers of the opposite hand (see Figure 7), then hook your thumb around the cradle in order to hold the Orthosis in place while you pull the handle around the cradle. Locator just below the Kneecap Cradle Figure 7: Fastening the Strap Fastening the strap can be performed with one hand although if the other hand is functional, it can also be used.
4. At this stage you should check to see if visually the Orthosis is in place (see figure 8). If not, take the Orthosis off and put it back on accurately.
Taking the Orthosis OFF 1. Make sure the system is OFF. 2. Unhook the strap handle from the cradle and take the Orthosis off. 3. Place the electrode cover over the electrodes. 4. Charge the Control Unit and RF Stim Unit's batteries fully at the end of your daily use (see Charging the Batteries). Operating the Control Unit Turning ON the system Press the button once. The system starts in standby mode.
Adjusting the Stimulation Intensity Level When the Control Unit is turned on, the stimulation intensity level starts at level 5, which is the default stimulation intensity level. Normally there is no need to adjust the stimulation intensity; however, it may be necessary while walking on different surfaces or with various shoes. When necessary, the stimulation level can be manually adjusted by pressing the or buttons on the Control Unit. If the intensity is reduced to 0, no stimulation will be applied.
Adjusting the Volume of the Audio Indication Use the buttons to adjust the volume: • Each time one of the buttons is pressed the volume increases or decreases. You will hear a corresponding beep at the volume you select. • Reducing the volume to the minimal setting mutes the Control Unit. • When you turn the system off, the volume level is saved unless the volume is set to "mute", in which case the volume level is automatically adjusted to the default level.
Chapter 5 Care and Maintenance Batteries The batteries should be charged before the first use, after every day’s use, and after extended storage. Low Battery Warning When one of the batteries is low, its indicator light on the Control unit flashes yellow.
Charging the Batteries Control Unit and RF Stim Unit • Both the Control Unit's and RF Stim Unit's batteries are rechargeable. • Remove Orthosis from leg while charging. 1. Open the cover of the charging socket at the bottom of the Control Unit and at the top of the RF Stim Unit as seen in Figure 9.
2. Connect the charger cable to the Control Unit and to the RF Stim Unit as seen in Figure 10 and plug into the wall socket. A rotating circular icon will appear on the Control Unit's display and the status light on the RF Stim Unit will start flashing alternating yellow/green .
3. Leave the charger connected until the appears on the Control Unit's , display and the RF Stim Unit's status light turns a constant green indicating a full charge. The charging process should last approximately 3 hours. Charging Fully Charged Battery \ cv Figure 11: Control Unit Charging Indicators Charging Fully Charged Battery Figure 12: RF Stim Unit Charging Indications 28 User’s Guide
Replacing the Batteries RF Stim Unit The RF Stim Unit's battery needs replacing approximately every 2 years by a NESS certified technician. Foot Sensor The battery in the Foot Sensor is not rechargeable, and needs replacing approximately every 6 months. To install a new battery (Lithium coin cell, CR2430): 1. Unscrew the two screws from the battery cover. 2. Slide the cover out. 3. Remove the old battery. 4. Insert the new battery (The “+” should face outwards). 5.
Control Unit The Control Unit’s battery is a rechargeable AAA battery and needs replacing approximately every 2 years. 1. Remove the screw from the battery cover on the back of the Control Unit. (The screw may be under an ID sticker-gently peel it off the screw). 2. Remove the battery cover. 3. Remove the old battery. 4. Insert a new battery (rechargeable AAA), according to the polarity marks in the battery socket. 5. Slide the cover back into place. 6. Tighten the screw.
Replacing Electrodes • The electrodes should be replaced at least every 2 weeks. It is recommended to replace the electrodes regularly in order to maintain optimal efficiency. The NESS L300™ should be used only with electrodes supplied by NESS Ltd. 1. Make sure the system is OFF. 2. Pull the used electrodes gently out of their bases (See Figure 15). Take care not to detach the electrode bases from the Orthosis.
3. Pull a new electrode off the electrode cover. Electrode Electrode Cover Protective Liner Figure 16: Removing a New Electrode from its Cover 4. Attach the new electrode to its base.
5. Remove and discard the protective liners from the electrodes before using the system. Protective Liner Figure 18: Removing the Protective Liners The electrodes should be slightly moistened approximately once a week.
6. Whenever the Orthosis is not on your leg the electrodes should be covered by the cover supplied with the electrodes.
Cleaning your NESS L300™ All parts may be cleaned by carefully wiping with a damp cloth. Electrical components are not waterproof, so do not immerse them in water. The Orthosis is the only component that can be immersed in water for cleaning. When the Orthosis needs a thorough cleaning: 1. Remove the RF Stim Unit (see "Removing and Installing the RF Stim Unit" section). 2. Immerse the Orthosis for 30 minutes into lukewarm water with a small amount of mild detergent. 3. Rinse thoroughly under running water.
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Chapter 6 Replacing and Installing System Components Replacing and Registering Components When one or more of the NESS L300™ electronic components are replaced, it needs to be electronically registered to ensure radio communication between the components of the system. New components that requires registration are: • • • 1. Control Unit RF Stim Unit Foot Sensor Make sure the Control Unit is turned OFF. 2. Press the seconds. and buttons simultaneously and hold them for 3 3.
6. The letter “E” (short for Error) will appear if the registration was unsuccessful. In such case, repeat steps 1-3. If the problem persists see the troubleshooting section. In the Process of Registering Registration Complete Registration Error Figure 20: Display while Registering Multiple Foot Sensors can be registered with one L300™ system, allowing you to use several pairs of shoes without the need to transfer your Foot Sensor from one shoe to another.
Removing and Installing the RF Stim Unit The RF Stim Unit should be removed only for the purpose of cleaning the Orthosis or for its replacement. Figure 21 shows how to detach the RF Stim Unit from the Orthosis cradle. 1. Release the RF Stim Unit from the cradle by pulling its upper edge out. 2. To reinstall the RF Stim Unit, insert the bottom prongs into the lower part of the cradle and push its upper part gently into the cradle until a snap sound is heard.
Placing a Foot Sensor in your Shoe The Foot Sensor should be placed under an insole. 1. Remove the insole from the shoe. 2. Stick an adhesive pad (included in the kit) in your shoe in the area directly below your heel. Shoe Insole Adhesive pad Figure 22: Foot Sensor Adhesive Pad in a Shoe 3. Place the Foot Sensor in the shoe, onto the adhesive pad with the wire pointing towards the toe area (also see the foot image on the sensor for correct alignment).
Pressure Sensor Foot Image Alignment Figure 23: Foot Sensor in Place Under Insole 4. Insert the insole into the shoe to cover the sensor, making sure any excess wire is tucked out of the way under the insole. 5. Attach the transmitter of the Foot Sensor to the inner rim of the shoe using the clamp. The NESS logo on the transmitter should face away from the shoe.
NESS Logo Faces away from the Shoe Clamp on inner rim of Shoe Figure 24: Transmitter in Place (Left Shoe Shown) 42 User’s Guide
Chapter 7 Accessories The NESS L300™ comes with accessories that are designed to help you avoid the inconvenience and distraction of holding your Control Unit. 1. Neck strap (supplied): The neck strap enables you to hang the Control Unit around your neck. If you find it more convenient you may insert the Control Unit into your shirt pocket. 2. Wrist strap (supplied): The wrist strap allows you to hang the Control Unit from your hand, or to pull it out of a pocket or pouch easily. 3.
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Chapter 8 Troubleshooting What should I do if… …I hear a beep, the RF Stim Unit's indicator on the Control Unit turns red and the letter "E" appears on the intensity display? This is a symptom of Bad Electrode Contact. To resolve this follow these steps: 1. Turn OFF the Control Unit. 2. Remove the Orthosis from your leg. • Make sure the electrode liner is removed and there is no interference to the contact between the electrodes and the skin. • Make sure that the electrodes are installed properly.
What should I do if… The Control Unit starts to beep, the system stops working, the Control Unit indicators start flashing red in succession and the letter "E" flashes on the intensity display? This is a symptom of Radio Communication Failure. Make sure that all the components are in radio range of each other and their batteries full. The system will not work if all components aren’t present or if one of the components isn’t working.
What should I do if… …during charging the letter "E" appears on the Control Unit display? An error occurred while charging. Try to reconnect the charger cable. If this doesn’t help replace the battery or contact your NESS L300™ distributor. … the Control Unit's display does not light up when I switch it ON? Make sure that the Control unit's battery is charged (see the section "Charging the batteries").
What should I do if… ...My NESS L300™ is stimulating, but there is no ankle movement or the foot does not move in a satisfactory way. This is a symptom of inaccurate positioning of the Orthosis on the calf. To resolve this follow these steps: 1. Turn OFF the system. 2. Take the Orthosis off your leg. 3. Reposition the Orthosis on your leg while making sure it is placed accurately, as described in the section "Putting on the Orthosis".
Chapter 9 Specifications Control Unit Specifications Classification Internally powered, continuous operation Operation modes Gait, Training Battery type Rechargeable AAA NiMH 1.2 V, 750 mAh On/Off illuminated button Controls Gait mode illuminated button for changing operation modes Intensity +/- buttons to fine-tune the intensity Volume +/- buttons control buzzer volume Indications Three status LEDs: Control Unit, RF Stim unit and Foot Sensor.
RF Stim Unit Specifications Classification Internally powered, continuous operation with type BF applied parts Operating voltage 3.7 V Battery type Proprietary rechargeable LiIon (Lithium Ion) 3.7 V, 700 mAh Indications Status (fault, battery, charging) and Stimulation LEDs Buzzer for audible indications Dimensions Height: 76mm Width: 43mm Depth: 14.
Symmetric Positive phase width Negative phase width 100 µS 200 µS 300 µS 100 µS 200 µS 100 µS 200 µS 300 µS 400 µS 800 µS Inter-phase 50 µS interval Total Pulse duration Max Load Pulse repetition rate Asymmetric 250 µS 450 µS 300 µS 1200 µS 0 650 µS 500 µS 1000 1500 µS µS 5000 Ω (Subject to Max Voltage limitation) 15- 45 Hz (5 Hz resolution) Gait Parameters Ramp up 0 - 2 seconds, 0.1 second resolution Ramp down 0 - 2 seconds, 0.
Orthosis specifications Orthosis Fabric-polymer Orthosis for single handed electrode relocation Limb size 29 - 51 cm limb circumference Height: 135 mm Dimensions Width: 100 mm Depth: 125 mm Weight Approximately 150 grams Electrode specifications Electrodes Two, 45 mm reinforced hydro gel electrodes Note: Use only electrodes provided by NESS Ltd.
Power Supply specifications (Charger) Voltage 5V ± 5% Current 1300 mA Note: Use only power supply provided/approved by NESS Ltd. Wireless link specifications Frequency band 2.4 GHz, ISM band Transmission power Complies with FCC 15.247 (for US) / ETSI EN300-440 (for Europe) Regulations.
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Chapter 10 List of Symbols Attention, See Instructions for Use Complies to United States and Canadian product safety standards Complies with the European Union medical device directive Serial Number Class II Type BF Applied Part Non-Ionizing Radiation Authorized European Representative Date of manufacture Manufacturer This product must not be disposed of with your other household waste Chapter 9 - Specifications 55
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