Bioness Neuromodulation A Bioness L300-STM-V10 L300 Orthosis Electronic Module User Manual Revision 2

Bioness Neuromodulation ltd. A Bioness Inc Company L300 Orthosis Electronic Module Users Manual Revision 2

Users Manual Revision 2

NESS L300 User Guide i NESS L300 User Guide
ii User Guide Copyright © 2005 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. 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 NESS Ltd's products. NESS Ltd. does not accept any responsibility for any damages caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel. Environmental Policy Service personnel are advised that when changing any part of the NESS L300, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. When the lifecycle of the NESS L300 TM has been completed, the product should be discarded according to the laws and regulations of the local authority. For more detailed information regarding these recommended procedures, please contact your local or regional NESS L300 distributor. NESS is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines. Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.
NESS L300 User Guide iii Manufacturer NESS Ltd. 19 Ha'haroshet St., Keidar Center P.O. Box 2500, Ra'anana 43654, Israel Tel: (972) 9-748-5738 Fax: (972) 9-748-5740 Email: ness@ness.co.il Website: www.NESSLTD.com U.S. Distributor Bioness Inc. 25134 Rye Canyon Loop Suite 300 Santa Clarita, California 91355 Tel: (800) 211-9136 Fax: (661) 702-6707 Email: info@bionessinc.com Website: www.bionessinc.com European Distributor NESS Europe, Zadelmakerstraat 53 2984 CC Ridderkerk, The Netherlands Tel: 31-180-481600 Fax: 31-180-463752 Email: ness@ness.nl Website: www.ness.nl
iv Table of Contents 1. INTRODUCTION TO YOUR NESS L300............................................. 1 CLINICAL ASPECTS..................................................................................1 ADVANCED TECHNOLOGY IN REHABILITATION............................................1 FOR YOUR HEALTH AND SAFETY...............................................................3 Contraindications ...................................................................................3 Warnings................................................................................................3 Precautions............................................................................................4 ADVERSE REACTIONS..............................................................................6 RADIO COMMUNICATION INFORMATION......................................................6 2. GENERAL OVERVIEW OF YOUR NESS L300.................................. 7 COMPONENTS OF THE NESS L300...........................................................7 THE ORTHOSIS........................................................................................8 Indicator lights on the orthosis electronic module ...................................9 THE FOOT SENSOR..................................................................................9 THE CONTROL UNIT...............................................................................11 Control Unit Buttons and Display..........................................................12 Operating the Control Unit....................................................................13 Control Unit Display and Audio Indications...........................................16 3. OPERATING MODES........................................................................... 18 STANDBY MODE.....................................................................................18 GAIT MODE............................................................................................18 TRAINING MODE.....................................................................................18 4. DAILY USE OF YOUR NESS L300 ..................................................... 19 ACTIVATING AND USING THE SYSTEM......................................................19 PUTTING ON THE ORTHOSIS....................................................................19 Positioning the orthosis on the leg........................................................20 TAKING OFF THE ORTHOSIS....................................................................24 5. CARE AND MAINTENANCE .............................................................. 25 CHARGING THE BATTERIES.....................................................................27
NESS L300 User Guide v REPLACING THE BATTERIES....................................................................29 Orthosis Electronic Module...................................................................29 Foot Sensor..........................................................................................29 Control Unit..........................................................................................30 REPLACING ELECTRODES.......................................................................31 CLEANING YOUR NESS L300 .................................................................32 6. REPLACING AND INSTALLING SYSTEM COMPONENTS ........33 REPLACING AND REGISTERING COMPONENTS...........................................33 REMOVING AND INSTALLING THE ORTHOSIS ELECTRONIC MODULE...........35 Placing a Foot Sensor in your Shoe .....................................................36 7. ACCESSORIES....................................................................................... 38 8. TROUBLESHOOTING.......................................................................... 39 9. SPECIFICATIONS................................................................................. 44 LIST OF SYMBOLS..................................................................................50
vi Table of Figures Figure 1: L300 System Components ................................................................. 7 Figure 2: The Orthosis ........................................................................................ 8 Figure 3: Foot Sensor ....................................................................................... 10 Figure 4: Control Unit........................................................................................ 12 Figure 5: Positioning the Leg ............................................................................ 20 Figure 6: Placing the Orthosis on the Leg ........................................................ 21 Figure 7: Fastening the Strap ........................................................................... 22 Figure 8: Orthosis Fastened in Place ............................................................... 23 Figure 9: Control Unit Charger Socket.............................................................. 28 Figure 10: Charging the Batteries..................................................................... 28 Figure 11: Charging Indicators ......................................................................... 28 Figure 12:Foot Sensor and Battery................................................................... 30 Figure 13: Control Unit and Battery .................................................................. 30 Figure 14: Digital Display while Registering ..................................................... 34 Figure 15: Removing the electronic module from the orthosis......................... 35 Figure 16: Foot Sensor in Place (Left Shoe Shown) ........................................ 36 Figure 17: Transmitter in Place on a Right Shoe.............................................. 37
NESS L300 User Guide 1 1. Introduction to your NESS L300 Clinical Aspects The NESS L300 system is intended for improving gait in people suffering from drop foot as a result of a central nervous system injury or disease. Drop foot is the inability or partial ability to raise the foot and toes toward the body (dorsiflexion). This condition is a common result of impairment or injuries to the central nervous system such as stroke, traumatic brain injury, multiple sclerosis, or cerebral palsy. Patients with drop foot tend to drag their foot during the swing phase of walking and usually try to compensate for the dragging by hiking their hip or swinging it in a circular motion (circumduction). These patients tend to be less stable, suffer the risk of frequent falls, and expend more energy when walking. The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the weak leg to provide flexion of the foot; thus, it may improve the individual’s gait. The NESS L300 also may facilitate muscle re-education, reduce muscle spasm, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow. Advanced Technology in Rehabilitation The NESS L300 system is comprised of an electronic orthosis, a foot sensor, and a control unit, which are ergonomically designed and aesthetically pleasing. The advanced ergonomic design of the orthosis ensures constant and snug contact of each electrode during limb motion and muscle contraction.
2 The NESS L300 system stimulates the common peroneal nerve in the lower leg causing the muscles that lift the foot and toes to contract. During walking the foot sensor detects when the foot is off the ground and sends a radio signal which initiates the stimulation causing the foot to move in a natural motion according to your walking pattern.
NESS L300 User Guide 3 For Your Health and Safety Contraindications • Patients with a demand-type cardiac pacemaker should not use the NESS L300. • Stimulation should not be applied over, or in proximity to, cancerous lesions. • The NESS L300 should not be used over areas of regional disorders, such as a fracture or dislocation, which would be adversely affected by motion from the stimulation. 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 electronic module of the orthosis. • Do not use the NESS L300 in close proximity (less than 3 feet) to short wave or microwave therapy equipment as it may produce instability in the orthosis electronic module output. • System configuration should only be performed by an authorized clinician.
4 Precautions • Patients with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained. • Inflammation in the region of the NESS L300 may be aggravated by motion, muscle activity or pressure from the orthosis. Use of the device should be temporarily halted until the inflammation clears. • Caution should be used for patients with suspected or diagnosed heart problems. • Caution should be used in the presence of the following: o When there is a tendency to hemorrhage following acute trauma or fracture. o Following recent surgical procedures when muscle contraction may disrupt the healing process. o Over areas of the skin which lack normal sensation. • 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. • The NESS L300 should be used only with electrodes supplied by NESS Ltd. • Specific physician clearance should be obtained prior to use in patients with alteration of normal arterial or venous flow due to local insufficiency, occlusion, arterio-venous fistula for the purpose of hemodialysis, or primary disorder of the vasculature.
NESS L300 User Guide 5 • Specific physician clearance should be obtained when there is a structural deformity or placement of metal implant in the area to be stimulated. • The safety of the NESS L300’s use during pregnancy has not been established. • Skin problems in areas of contact with the orthosis may be aggravated by use of the NESS L300. • The NESS L300 should be turned off before removing or replacing the electrodes. • The NESS L300 should be kept out of the reach of children. • The NESS L300 Control Unit is splash proof. However, it should be protected it from any contact with water such as dampness from sinks, bathtubs and shower stalls, from weather such as rain or snow or any other source of water. • 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. It should not be applied to anyone else or any other part of the body. • Put on the orthosis only when the NESS L300 is turned off. Do not activate it until it is fastened in place. • The system should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
6 Adverse Reactions In the unlikely event of any of the following occurrences, stop using your NESS L300 immediately and consult your personal physician. • Signs of significant skin irritation or pressure sores on the limb in areas of contact with the orthosis. • 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. Radio Communication Information This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions (1) This device may not cause harmful interference. (2) 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency 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 help. Changes or modifications to this equipment not expressly approved by the NESS Ltd. could void the user’s authority to operate the equipment. The antenna for each transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
NESS L300 User Guide 7 2. General Overview of your NESS L300 Components of the NESS L300 The NESS L300 is supplied with the following components: o Control Unit o Orthosis o Orthosis Electronic Module o Foot sensor o Electrodes o Carrying case o User Manual o Charger (supplied separately) Figure 1: L300 System Components in carrying case
8 The Orthosis Figure 2: The Orthosis • The orthosis is light weight and has a low profile allowing it to be easily positioned under trousers. • It is anatomically designed to allow accurate placement on the leg. • An electronic module containing the stimulator, battery and communication circuit, is integrated into the orthosis cradle. It may be snapped in or out of the orthosis for maintenance or cleaning. • The entire device is held in place by an adjustable elastic strap which may be fastened easily using one hand. • Two electrodes are attached to their bases on the inner lining of the orthosis. Their position in the orthosis has been Electronic ModuleHandle Locator Electrode base & electrode Cradle Elastic StrapStatus light Stimulation light
NESS L300 User Guide 9 carefully determined by the clinician during fitting. The electrodes may be easily replaced by the user without changing their positions Indicator lights on the orthosis electronic module Indicator lights on the electronic module display the status of the unit and when stimulation occurs. System on Flashes green Low battery Flashes yellow Charging Alternating between yellow and green Battery fully charged Constant Green Status Light Malfunction Constant or flashing red light Stimulation applied Flashes rapid yellow Stimulation Light Stimulation inactive Flashes slow yellow 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 electronic module in the orthosis, according to which the stimulation is activated. The foot sensor consists of a pressure sensor worn underneath the inner sole of the shoe, along with a small transmitter attached to the upper edge of the shoe by a special clip.
10 There is no need to detach the foot sensor between uses. The foot sensor transmitter is powered by a small non-rechargeable battery which needs replacing approximately every six months of use. The foot sensor by default should be placed under the paretic (weak) foot. In some cases the foot sensor may be placed under the non-paretic foot according to a clinician's judgment. Note The foot sensor should be placed only under the foot designated by the clinician. Figure 3: Foot Sensor Transmitter Pressure Sensor Clip
NESS L300 User Guide 11 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. It can be carried around the neck using the neck strap supplied, in a pocket or belt pouch. It is powered by a single rechargeable AAA battery. During operation, the control unit maintains two-way communication with the electronic module in the orthosis. If communication is lost the system will cease working. Operating Button Description ON/OFF Turns the control unit ON and OFF Trigger mode Selects Gait, Training or Standby Mode Volume Adjustment Adjusts the volume of the audio indications Intensity Adjustment Adjusts the intensity of stimulation
12 Control Unit Buttons and Display Figure 4: Control unit buttons and display ON/OFF Button Trigger Mode Button Intensity Level Buttons Neck Strap Hole Control Unit indicator light Intensity Indicator Foot Sensor Indicator Light Orthosis Indicator Light Volume Adjustment buttons
NESS L300 User Guide 13 Operating the Control Unit Turning on the system Press the On/Off button once. The system will automatically start in Standby Mode. All display indicators will light up for a few seconds while the system performs a self-test, then the On/Off button flashes green to indicate that the system is activated. Selecting the Mode To select the Gait Mode: after the unit is turned on, press the trigger mode button once briefly. You should hear a beep and the trigger mode button will begin to blink slowly. During stimulation the button blinks rapidly. To select the Training Mode: after the unit is turned on, press the trigger button and hold it for 3 seconds (long press), until a beep is heard. The trigger mode button will begin to blink slowly. In addition, the intensity indicator displays a “t” alternating with the intensity. To go back to the Standby Mode: from the Gait or Training mode, press the trigger button again briefly, you should hear a beep, and the trigger mode button will stop blinking.
14 Adjusting the stimulation intensity level During the fitting process your clinician set the stimulation type and intensity according to your exact needs, normally there is no need to adjust the stimulation intensity however it may be necessary while walking on different surfaces or with various footwear. To lift the foot higher: If the foot slightly drags or catches on the floor while walking the stimulation level should be increased by pressing the "+" button. To decrease foot lift: If you feel that your foot rises too high while walking or that the stimulation is unpleasant, the intensity level can be reduced by pressing the "-" button. After reducing the intensity take care that your foot doesn’t drag or catch on the floor. • When the intensity level is altered the intensity level appears on the display of the control unit and a corresponding beep is emitted • When the system is turned on the intensity is automatically set to “5” which is the intensity set by the clinician if the intensity is reduced to “0” there will be no stimulation. Note Do not increase the stimulation intensity level set for you by your clinician by more than two levels without first consulting him or her.
NESS L300 User Guide 15 Adjusting the volume of the audio indication Use the volume and buttons to adjust the volume. • Each press of the button will increase or decrease the volume, and you will hear a beep at the volume you have selected. • Reducing the volume to the minimal setting will mute the control unit. • When you turn the system off, the volume level will be saved unless the volume was set to "mute," in which case the volume level will be automatically adjusted to the default level.
16 Control Unit Display and Audio Indications Visual Display Color Flash Meaning On/Off Button Green Slow System is activated Slow System in gait or training mode but not stimulating Trigger mode button Yellow Rapid System in gait or training mode and stimulating All display lights Red, yellow and green Alternating colors one after the other for 1.5 seconds Self-test at startup 0-9 Intensity level setting The letter “t” and intensity digit alternate Training Mode Intensity indicator Segments of the digit rotate in a circular pattern Charging
NESS L300 User Guide 17 Audio indications The audio alert beeps when: • The system is first turned on. • The battery is weak. • There is an indication, such as a malfunction, which will be indicated visually on the control unit. • When the control unit is separated from the system, for example when the system is worn, and the controller is left on a table.
18 3. Operating Modes Standby mode The system is ON, and waiting for commands. Stimulation is not applied in the Standby mode. Note While using the system, the various components of your NESS L300 must not be separated. If the system components are separated for any reason, radio contact will be lost and the system will cease all activity until communication is reestablished. Gait mode Select this mode for walking. In the Gate mode the stimulation is synchronized by the foot sensor, in order to achieve foot lifting during the swing phase of walking and foot rest during the stance phase. Training mode Select this mode for muscle training while you are sitting or lying down. The purpose of the training mode is to facilitate muscle re-education, prevent or retard disuse atrophy of the calf muscles, maintain or improve range of motion of the ankle joint, reduce spasticity and improve local blood circulation. In the training mode the stimulation is applied in pre-determined cycles adjusted by your clinician and works independently of the foot sensor Note The training mode can also be used to check if the orthosis was placed accurately on the leg. If the foot does not respond to the stimulation as it should, the user should reposition the orthosis
NESS L300 User Guide 19 4. Daily Use of your NESS L300 Activating and Using the System Make sure the foot sensor is installed, if not, then install it according to the section “Placing the Foot Sensor in your Shoe.” 1. Remove the protective covers from the electrodes Put on the orthosis. Turn on the control unit. Select either the gait or training mode. Begin walking or let the training mode exercise your leg in place. Putting on the orthosis In order to ensure proper foot movement make sure the orthosis is positioned accurately. Note Before putting on the orthosis make sure to remove the protective covers from the electrodes.
20 Positioning the orthosis on the leg While seated, slightly extend the lower leg as in Figure 5. This causes the outline of the kneecap to be clearly defined. It may be helpful to place the foot on a small stool or footrest. Figure 5: Positioning the Leg This point under your knee is where the locator (see fig. 2) of the orthosis fits.
NESS L300 User Guide 21 1. Place the orthosis onto the leg, with the "U" of the upper edge, called the Locator, snugly, but comfortably against the lower part of the kneecap, as in Figure 6. Figure 6: Placing the Orthosis on the Leg 2. After the locator is in position, slide the orthosis against the leg so that it fits snugly under the kneecap. The orthosis will gently grip the leg. Make sure it remains in place until you fasten the strap according to one of the methods described below. Locator Elastic strap is on the outside of the leg before fastening. Handle
22 Fastening the strap The fastening of the strap is meant to be performed with one hand although if the other hand is functional, it is easier to use both hands. 1. With the orthosis in place as in Figure 7, carefully grasp the handle of the elastic belt with the fingers of the opposite hand. In Figure the orthosis is on the right leg, so the handle is grasped by the left hand. Figure 7: Fastening the Strap (First Method) 2. Placing your thumb on the cradle, hold the orthosis in place while you pull the handle toward the cradle and position it around the cradle. Attaching Point of Cradle Locator just below the kneecap
NESS L300 User Guide 23 Figure 8 shows the orthosis when it is placed correctly on the right leg. Figure 8: Orthosis Fastened in Place Note "Bad electrode contact" indication If for any reason there is no contact between the electrodes and the skin, all the indication lights will start flashing red and no stimulation will be applied, to resolve this see the troubleshooting section. Locator just below the kneecap Handle seated on attaching point of the cradle Electronic Module
24 Taking off the Orthosis 1. Press the On/Off button once to shut the system OFF. 2. Unhook the strap handle of the orthosis, and remove the orthosis. 3. Moisten the electrodes and place protective covers over them. 4. Charge the battery fully at the end of your daily use.
NESS L300 User Guide 25 5. Care and Maintenance Batteries Note The batteries must be charged before the first use, after every day’s use, and after extended storage. Low Battery Warning When one of the component batteries is low, its indicator light on the control unit flashes yellow; for more information see the following table: Starts to flash slowly accompanied by an audio indication. Orthosis battery is low- Approx. 4 hours use left. Medium speed flash, audio indication every 10 minutes Orthosis battery is low- Approx. 1 hours use left. Low Battery in the Orthosis Rapid Flashing and an audio indication every 1 minute Orthosis battery is low-Approx. 10 minutes use left. Starts to flash slowly accompanied by an audio indication. Control unit battery is low- Approx. 4 hours use left. Medium speed flash, audio indication every 10 minutes Control unit battery is low- Approx. 1 hours use left. Low Battery in the Control unit Rapid Flashing and an audio indication every 1 minute Control unit battery is low-Approx. 10 minutes use left.
26 Starts to flash slowly accompanied by an audio indication. Foot sensor battery is low- Approx. 14 days of use left. Medium speed flash, audio indication every 2 hours. Foot sensor battery is low- Approx. 7 days of use left. Rapid Flashing and an audio indication every hour Foot sensor battery is low-Approx. 2 days of use left. Low Battery in the Foot sensor Rapid Flashing and an audio indication every 30 seconds Foot sensor battery is low-Approx. 15 minutes of use left
NESS L300 User Guide 27 Charging the Batteries Control Unit and Orthosis Note Only the Control and Orthosis units' batteries are rechargeable. 1. Open the cover of the charger socket at the bottom of the control unit as in Figure 9. Figure 9: Control Unit Charger Socket
28 2. Connect the charger cable to the control unit and the orthosis electronic module as in Figure and plug into the wall socket. You should see a circular charging icon on the control units' digital display and the status light on the module should start flashing alternating between yellow and green. Figure 10: Charging the Batteries Leave the charger connected until the letter "F" appears on the control units' digital display and the orthosis electronic modules' status light turns a constant green, indicating a full charge. The charging process should last approximately 3 hours. Charging Icon Figure 11: Charging Indicators
NESS L300 User Guide 29 Replacing the Batteries Orthosis Electronic Module The electronic module’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): 3. Unscrew the screws from the battery cover. Slide the cover out. Remove the old battery. Insert the new battery (The “+” should face up). Slide the cover back into place and reinstall the screws. Tip: If you are unable to replace the battery yourself, your clinician or local watchmaker should be able to assist you Screw Cover Battery Figure 12: Replacing the Foot Sensor’s Battery
30 Control Unit The control unit’s battery is a rechargeable AAA battery and needs replacing approximately every 2 years. Note The batteries must be charged before the first use, after every day’s use, and after extended storage. 1. Remove the screw from the battery cover on the back of the control unit. 2. Remove the battery cover. Remove the old battery. 3. Insert a new battery (rechargeable AAA), according the “+” and "-" marks in the battery socket. 4. Slide the cover back into place and tighten the screw. Figure 13: Control Unit and Battery Control Unit Battery Cover and Screw BatteryTip: If you are unable to replace the battery yourself, your clinician or local watchmaker should be able to assist you
NESS L300 User Guide 31 Replacing Electrodes The electrodes should be replaced every 2-3 weeks. It is recommended to replace the electrodes regularly in order to maintain optimum efficiency. Attention The NESS L300 should be used only with electrodes supplied by NESS Ltd. 1. Make sure the system is off 2. Pull the electrode gently out of its base. Take care not to detach the electrode base, which is attached to the inside of the orthosis. 3. Snap in a new electrode, and make sure it's firmly attached to the electrode base. 4. Remove the protective cover from the electrode before using the system. The cover should be put aside and saved, for later use.
32 Cleaning your NESS L300 All parts may be cleaned by wiping with a damp cloth. Electrical components are not waterproof, so do not immerse them in water. When the orthosis needs a thorough cleaning: 1. Remove the electronic module. 2. Immerse in lukewarm water with a small amount of mild detergent. 3. Rinse thoroughly and let dry in the shade (do not hang). 4. Reattach the electronic module after the orthosis is completely dry. Do not use a washing machine or drier.
NESS L300 User Guide 33 6. Replacing and Installing System Components Replacing and registering components When one or more of the NESS L300 electronic components are replaced, a procedure must be performed to register the new component as part of the system. This ensures that there is radio communication between the components of the system. These components are: • Stimulation unit • Foot sensor • Electronic control unit 1. Make sure the control unit is turned OFF. 2. Press the “Trigger mode button” and “-” button at the same time and hold them for 3 seconds. The segments of the stimulation intensity display will light up in 2 alternating circular patterns until the registration is complete (See Figure ). The letter “C” (short for connected) will appear if registration was successful and a green light will appear on the control unit indicating a successfully registered component Note If the component registered was the orthosis' electronic module its status light will also turn green.
34 The letter “E” (short for Error) will appear if the registration was unsuccessful. If the letter “E” appears, repeat steps 1-3, if the problem persists see the section "troubleshooting." In the process of registering Registration Complete Registration Unsuccessful Figure 14: Digital Display while Registering
NESS L300 User Guide 35 Removing and Installing the Orthosis Electronic Module The following figure shows how to detach the electronic module from the orthosis, this should be done only for cleaning the orthosis, or for maintenance purposes. 1. Pull the upper edge of the electronic module out of the cradle. 2. Pull the electronic module out of the cradle. 3. To reinstall the module, insert the bottom part into the cradle and push the module gently into the cradle to reinstall. Figure 15: Removing the electronic module from the orthosis Note No more than one control and stimulation unit can be registered in your system at any time, registering a new unit will automatically remove your old unit from the system.
36 Placing a Foot Sensor in your Shoe The foot sensor should be placed under the shoes' insole. 1. Remove the inner sole of the shoe. 2. Place the pressure sensor in the shoe, directly below where the center of your heel fits, with the adhesive side downward. Figure 16: Foot Sensor in Place (Left Shoe Shown) 3. Press the sensor to fasten it to the shoe. 4. Insert the inner sole of the shoe; making sure any excess wire is tucked out of the way under the inner sole. 5. Attach the transmitter of the foot sensor to the upper edge of the inner side of the shoe The NESS logo on the transmitter should face away from the foot. Pressure Sensor Transmitter Attaching Clip
NESS L300 User Guide 37 Figure 17: Transmitter in Place on a Left Shoe Note Up to four different foot sensors can be used with one L300 system, allowing you to use several pairs of shoes without the need to transfer your foot sensor from shoe to shoe. NESS Logo faces away from foot
38 7. Accessories The NESS L300 comes with a variety of accessories that are designed to help you avoid the inconvenience and distraction of holding your control unit. 1. Neck strap: The neck strap allows you to hang the control unit around your neck. If you find it more convenient you may insert it into your shirt pocket. 2. Wrist strap: 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. Belt pouch: This small pouch fits on your belt for quick and easy storage of the control unit.
NESS L300 User Guide 39 8. Troubleshooting To locate your local NESS L300 distributor, call 972-9-7485738 or visit our website: www.nessltd.com Error light indications Indicators Color Flash Meaning Red Cycles between Control unit, Orthosis, and Foot Sensor, also “E” appears on digital display Radio communication lost All three Component lights on the control unit Red All the component lights flash simultaneously. “E” flashes on the digital display. Bad electrode contact with the calf. Indicator Color Flash Meaning Flashing Malfunction-dangerous to the hardware Red Constant Fault-dangerous to the owner or charge malfunction Orthosis, Foot sensor or Control unit indication light Yellow Flashing Low battery
40 Problems and their solutions Problem Solution Any part of your NESS L300 kit (Orthosis, Stimulation Unit, Control Unit, Foot Sensor etc.) is broken, damaged or becomes detached. Contact your NESS L300 distributor. The Control Units' display does not light up when you switch ON the Control Unit. Make sure the battery is charged (see the section "Charging the batteries" for instructions). If, after charging the battery, the Mode display still does not appear, contact your NESS L300 distributor. A problem which is not covered in this manual occurs Contact your NESS L300 distributor. During charging, "E" appears on the screen. Try to reconnect the charger cable, if this doesn’t help contact your NESS L300 distributor. Electrodes are frayed, peeling, damaged, or falling off the Orthosis. Replace with new electrodes according to the section "Replacing Electrodes" After charging your batteries, they are still low. Your batteries need replacing.
NESS L300 User Guide 41 Problem Solution No error indications appear, but there is no movement of the ankle. 1. Turn OFF the system. 2. Take the Orthosis off your calf. 3. Put the Orthosis on your calf while making sure that the Orthosis is properly positioned on your calf, as described in "Putting on the orthosis" 4. Turn ON the Control Unit again, and press the Trigger Button. If there is still no ankle movement contact your NESS L300 distributor. I feel stimulation from the orthosis, but my foot does not respond in a satisfactory way. 1. Make sure that the Orthosis is snug against your calf and that the electrodes are in close contact with the skin. 2. Make sure you are in the desired mode. If the ankle movement is still unsatisfactory, turn OFF the system. 3. Remove the Orthosis, then replace it on your calf, making certain that the Orthosis is positioned correctly, as described in "Putting on the orthosis" If the configuration is still unsatisfactory, contact your NESS L300 distributor. System malfunction indication appears. Cease use of system and contact your NESS L300 distributor.
42 Problem Solution The "bad electrode contact" indication appears. 1. Turn OFF the system. 2. Remove the orthosis from your leg. 3. Make sure the electrode protective covers were removed and there is no disturbance to contact between the electrodes and the skin. 4. Make sure that the electrodes are installed properly according to section "Replacing Electrodes"), and that a snapping sound was heard when the electrode was inserted into its base. 5. The electrodes may be missing or damaged if this is the case then install new electrodes according to section "Replacing Electrodes" 6. Put the Orthosis on your calf, turn the Control Unit ON again, and press the Trigger button. If the problem persists then: 7. Check that the orthosis electronic module is in place and locked it (see the section Removing and Installing the Orthosis Electronic Module), if not reattach it to the orthosis. If the problem persists then contact your NESS L300 distributor.
NESS L300 User Guide 43 Problem Solution "Radio communication lost" indication appears. Make sure that all the components are in radio range of each other, the system will not work if all components aren’t present.
44 9. Specifications Control Unit Specifications Classification Internally powered, continuous operation Operation Modes Gait, Training Operating voltage 1.2 V Operation current 30 mA Battery type Rechargeable AAA NiMH 1.2V, 750 mAh Charging time 4.5 Hours (typical) using provided power supply Charging cycles At least 300 charging cycles Operation period At least 2 days between charges Shelf life At least 2 weeks between charges Controls On/Off illuminated button Trigger mode button for changing system modes Intensity +/- buttons to enable the user fine tune intensity Volume +/- buttons controls buzzer volume Indications 3 Status LED: Control Unit, Orthosis Electronic Module – Indicate battery & component status Numerical display designates relative stimulation intensity Illuminated buttons designates system operation mode. Buzzer for audible indications Carrying Wrist strap, Neck strap, Pouch Dimensions Height: 71mm Width: 46mm Depth: 17.5mm Weight 45 grams
NESS L300 User Guide 45 Water protection IPX1 Environmental :Transport & Storage: 0 – 35 Cº Operating: 0-45 Cº Charging: 10-45 Cº ( 50-113 F º ) 10% to 85% relative humidity 900hPa to 1060hPa atmospheric pressure Orthosis Electronic Module Specifications Classification Internally powered, continuous operation with type BF applied parts Operating voltage :3.7 V Operation current :70 mA Battery type :Rechargeable Prismatic LiIon (Lithium Ion) 3.7V, 700 mAh Charging time :3 Hours (typical) using provided power supply Charging cycles :At least 350 charging cycles Operation period :At least 2 days between charges Battery discharge time when stored :At least 1 week between charges Indications :Status (fault, battery, charging) & Stimulation LEDs Buzzer for audible indications Pulse Parameters Drive method: Constant current Intensity 0-80 mA, 1 mA resolution (measured at positive phase) Shape: Symmetric Asymmetric
46 Positive phase width 100 µS 200 µS 300 µS 100 µS 200 µS 300 µS Negative phase width: 100 µS 200 µS 300 µS 400 µS 800 µS 1200 µS Intra-phase interval 50 µS 0 Pulse duration 250 µS 450 µS 650 µS 500 µS 1000 µS 1500 µS Max load 1100 Ω 800 Ω 500 Ω 1300 Ω 1100 Ω 900 Ω Gait Parameters Pulse repetition rate 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,15, 20, 25, 30, 35, 40, 45 PPS Ramp up 0-4 Sec, 0.1 Sec resolution Ramp down 0-4 Sec, 0.1 Sec resolution Delay 0-3 Sec, 0.1 Sec resolution Max duration 0-10 Sec, 0.1 Sec resolution Training Parameters On time 1-8 Sec, 1 Sec resolution Off time 2-15 Sec, 1 Sec resolution Ramp up 0-4 Sec, 1 Sec resolution Ramp down 0-4 Sec, 1 Sec resolution Total time 1-60 Min Application Attached to a cradle in the NESS L300 Orthosis
NESS L300 User Guide 47 Dimensions Height: 74mm Width: 43mm Depth: 15mm Weight 53.7 grams Water protection IPX1 Environmental Transport & Storage: 0 – 35 Cº Operating: 0-45 Cº Charging: 10-45 Cº ( x-x F º ) 10% to 85% relative humidity 900hPa to 1060hPa atmospheric pressure Orthosis specifications Orthosis Fabric-Polymer orthosis for electrode relocation and single handed attachment Limb size 28 – 50 cm limb circumference Maintenance Immerse in cold water when needed and let dry in free air. NOTE: First remove stimulator NOTE: DO NOT use drier Dimensions Height: 160mm Width: 100mm Depth: 125mm Weight Approx 160 grams
48 Electrode specifications Electrodes Two, 45 mm reinforced hydrogel electrodes. NOTE: Use only electrodes provided by NESS Ltd. Electrode base Two relocateable polymer electrode bases for individual fitting Foot Sensor Specifications Classification Internally powered, continuous operation with type BF applied part Operating voltage 3.0 V Operation current 20 µA Battery type Lithium coin cell, CR2430, 280 mAh Operation period 6 months (typical) Shelf life 2 years Transducer Force Sensitive Resistor. Attachment To the inner side of shoe lining using clip Dimensions of the transmitter Height: 80mm Width: 50mm Depth: 10mm Weight 35 grams Water protection IPX4 Environmental Transport & Storage: 0 – 35 Cº Operating: 0-45 Cº Charging: 10-45 Cº ( x-x F º ) 10% to 85% relative humidity 900hPa to 1060hPa atmospheric pressure
NESS L300 User Guide 49 Power Supply specifications Voltage 5V ± 5% Current 1300 mA Note: Use only power supply provided/approved by NESS Wireless link specifications Frequency band 2.4 GHz, ISM band Transmission power Complies with regulations (FCC 15.247 for US / ETSI EN300-440 for Europe).
50 List of Symbols Attention, See Instructions for Use Serial Number IPX1 Drip - proof IPX4 Splash -proof IPX7 Watertight (immersible) Class II Type BF Applied Part Non-Ionizing Radiation

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