Bioness Neuromodulation A Bioness L300-STM-V20 L300 Orthosis Electronic Module User Manual user guide L300 27 3 indd

Bioness Neuromodulation ltd. A Bioness Inc Company L300 Orthosis Electronic Module user guide L300 27 3 indd

Users Manual Revised

User's GuidePart No: B0001002 Rev 1
IIUser 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.TrademarksNESS 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 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™, 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™ 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.Conformity Certification Caution: Federal law restricts this device to sale by or on the order of a physician.Manufacturer NESS Ltd. 19 Ha'haroshet St., Keidar Center, P.O. Box 2500, Ra'anana, 43654, IsraelTel: (972) 9-748-5738 Fax: (972) 9-748-5740, Email: ness@ness.co.il, Website: www.nessltd.comEuropean DistributorNess Europe B.V, Zadelmakerstraat 532984 CC Ridderkerk, The Netherlands Tel: 31-180-481600 Fax: 31-180-463152Email: ness@ness.nlWebsite: www.ness.nlU.S. DistributorBioness Inc. 25134 Rye Canyon Loop Suite 300Santa Clarita, California 91355 Tel: (800) 211-9136 Fax: (661) 362-4851Email: info@bionessinc.comWebsite: www.bionessinc.com
IIIContents 1. Introduction to your NESS L300™................................................ 1Indications For Use........................................................................... 1Advanced Technology in Rehabilitation............................................ 1For Your Health and Safety............................................................... 22. General Overview of your NESS L300™.............................................. 7 Components of the NESS L300™.................................................... 7The Orthosis..................................................................................... 8 Indicator lights on the RF Stim Unit............................................ 9The Foot Sensor............................................................................... 10The Control Unit................................................................................ 11 Control Unit Buttons.................................................................... 12 Control Unit Display and Audio Indication................................... 133. Operating Modes............................................................................. 15Standby Mode................................................................................... 15Gait Mode.......................................................................................... 15Training Mode................................................................................... 154. Daily Use of your NESS L300™..................................................... 17Activating and Using the System...................................................... 17Positioning the Orthosis on your leg................................................. 18
IVTaking the Orthosis off....................................................................... 22Operating the Control Unit.................................................................225. Care and Maintenance.................................................................... 25Batteries............................................................................................ 25Low Battery Warning........................................................................ 25Charging the Batteries...................................................................... 26Replacing the Batteries.................................................................... 29Replacing Electrodes........................................................................ 31Cleaning your NESS L300™............................................................ 356. Replacing and Installing System Components............................ 37Replacing and Registering Components........................................... 37Removing and Installing the RF Stim Unit......................................... 39Placing a Foot Sensor in your Shoe................................................. 407. Accessories.................................................................................... 438. Troubleshooting............................................................................. 459. Specifications................................................................................. 4910. List of Symbols................................................................................ 55
VList of FiguresFigure 1: NESS L300™ System Components .......................................7Figure 2: The Orthosis ...........................................................................8Figure 3: The Foot Sensor ...................................................................10Figure 4: The Control Unit ................................................................... 11Figure 5: Recommended Knee Angle for Orthosis Application ............18Figure 6: Placing the Orthosis on the Leg ...........................................19Figure 7: Fastening the Strap ..............................................................20Figure 8: Orthosis Fastened in Place .................................................21Figure 9: RF Stim Unit and Control Unit Charging Sockets .................26Figure 10: Connecting the Charger .......................................................27Figure 11: Control Unit Charging Indicators ..........................................28Figure 12: RF Stim Unit charging Indicators ..........................................28Figure 13: Replacing the Foot Sensor’s Battery ....................................29Figure 14: Replacing the Control Unit's Battery .....................................30Figure 15: Removing Used Electrodes ..................................................31
VIFigure 16: Removing a New Electrode from its Cover ...........................32Figure 17: Attaching a New Electrode ...................................................32Figure 18: Removing the Protective Liners ............................................33Figure 19: Attaching the Electrode Cover ..............................................34Figure 20: Display while Registering .....................................................38Figure 21: Removing the RF Stim Unit from the Orthosis .....................39Figure 22: Foot Sensor Adhesive Pad in a Shoe ...................................40Figure 23: Foot Sensor in Place under Insole .......................................41Figure 24: Transmitter in Place (Left Shoe Shown) ...............................42Figure 25: Accessories ..........................................................................45
1Chapter 1 - IntroductionIntroduction to your NESS L300TMIndications For Use The NESS L300™ is intended to provide ankle dorsiflexion in individualswith 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 theindividual’s gait. The NESS L300™ may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow. Advanced Technology in RehabilitationCentral nervous system injuries often cause a gait disorder called "Foot Drop" which is the inability to raise the foot while walking and therefore results in dragging of the foot, instability and increased effort during gait.The NESS L300™ is an advanced Neuroprosthesis designed to improve gait in people suffering from foot drop as a result of a central nervous system injury or disease. The NESS L300™ system is comprised of an Electronic Orthosis, Foot Sensor and Control Unit. These components communicate wirelessly, thus enabling easy and comfortable use without cumbersome wires. The NESS L300™ delivers electrical pulses to the Peroneal Nerve which controls the movement of the calf muscles, causing them to raise the foot at the appropriate phase of walking and therefore prevents foot drop.The Orthosis can be used single handedly and its advanced ergonomic design ensures constant and snug contact between the user's limb and its 1Chapter
2User’s Guideintegrated 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.Please read this guide carefully in order to maximize the benefits providedby this advanced system.For Your Health and SafetyContraindications• 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.• Patients with an implanted electronic metallic device (for example a cardiac pacemaker or defibrillator) should not be subjected to stimulationunless specialist medical opinion has first been obtained.
3Chapter 1 - IntroductionWarnings• The long-term effects of chronic electrical stimulation are unknown.• The Orthosis should not be applied over swollen, infected, or inflamed areasor 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.• 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 RF Stim Unit output.• System configuration should only be performed by an authorized clinician.Precautions• 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 hemmorage 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.
4User’s Guide• 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 patientswith 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.• Specific physician clearance should be obtained when there is a structuraldeformity 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 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.
5Chapter 1 - Introduction• 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 thebody.• 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.Adverse ReactionsIn 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 areasof 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.• Skin irritations and burns have been reported with the use of powered muscle stimulators.• Any other unanticipated reaction.
6User’s GuideRadio Communication InformationThis 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. 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.The antenna for each transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.Changes or modifications to this equipment not expresslyapproved by NESS Ltd. could void the user’s authority to operate the equipment.
7Chapter 2 - General Overview of your NESS L300™General Overview of your NESS L300TMComponents 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 caseChargerControl UnitUser GuideFoot SensorElectrodesOrthosis Figure 1: NESS L300™ System Components2Chapter
8User’s GuideThe OrthosisElectrode LocatorStrapHandleCradleStatus LightStimulation LightRF Stim Unit StrapElectrode Base 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.
9Chapter 2 - General Overview of your NESS L300™• 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 easilyreplaced by the user without changing their positions. Indicator lights on the RF Stim UnitIndicator lights on the RF Stim Unit displays the unit's status and when stimulation occurs.Indicator Display Display Pattern DescriptionStatus Light Flashes green System onFlashes yellow Low batteryAlternating between yellow and green Charging Constant Green Battery fully chargedStimulation Light Flashes slowly yellow Stimulation inactiveFlashes rapid yellow Stimulation applied
10 User’s GuideThe Foot SensorThe 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 Foot Sensor is powered by a small non-rechargeable battery which needs replacing after approximately every six months of use.The Foot Sensor by default should be placed under the paretic (weak) foot.TransmitterClampPressure SensorFigure 3: The Foot Sensor
11Chapter 2 - General Overview of your NESS L300™The Control UnitThe Control unit (see figure 4) enables the user to activate/deactivate thesystem, select the operation mode, fine-tune the stimulation intensity andreceive 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.On/Off ButtonGait mode Button Intensity adjustment ButtonsIntensity IndicatorVolume Buttons Control Unit Indicator Foot Sensor Indicator RF Stim Unit Indicator Figure 4: The Control Unit
12 User’s GuideControl Unit ButtonsControl UnitOperating ButtonDescriptionON/OFF Turns the Control Unit ON and OFFGait mode Selects Gait, Training or Standby ModeVolume Adjustment Adjusts the volume of the audio indicationsIntensity Adjusts the intensity of stimulation
13Chapter 2 - General Overview of your NESS L300™Control Unit Display and Audio IndicationsVisual IndicationsControl Unit Display Display Pattern DescriptionFlashes Green System is ON Flashes Yellow SLOWLYSystem in Gait or Training mode, but not Stimulating Flashes Yellow RAPIDLYSystem in Gait or Training mode and Stimulating Displays 0 - 9 Intensity level Alternates “t” and the intensity level Training modeOne of the Indications Flashes YellowLow BatteryRotating Circle ChargingHorizontal LineFully Charged
14 User’s GuideAudio indicationsThe 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.Error indicationsDisplay Display Flash Meaning The RF Stim Unit's Indicator is Constantly Red and “E” appears on the Intensity IndicatorBad Electrode Contact All indicators flash Redand “E” flashes on theIntensity IndicatorRadio Communication failure between the Control Unit and RF Stim Unit The Foot Sensor's Indicator is Constantly Red and the Intensity value flashesFoot Sensor not found by the system One of the Indicators is Constantly RedComponent Malfunction
15Chapter 3 - Operating ModesOperating ModesStandby modeThe system is ON, and waiting for commands. Stimulation is not applied in Standby mode.Gait modeSelect 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 modeSelect 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 retard disuse atrophy of the calf muscles, maintain or improve range of motion of the ankle joint 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.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, reposition the Orthosis.3Chapter
17Chapter 4 - Daily Use of your NESS L300™Daily Use of your NESS L300TMActivating and Using the System1. 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”. 4Chapter
18 User’s GuidePositioning the Orthosis on your leg1. 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 toplace your foot on a small stool or footrest. The point under your Kneecap where the Locator of the Orthosis Should fit.Figure 5: Recommended Knee Angle for Orthosis Application
19Chapter 4 - Daily Use of your NESS L300™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. Strap HandleLocatorFigure 6: Placing the Orthosis on the LegAfter the Orthosis is in position, push the Orthosis against the leg. The Orthosis will gently grip the leg.
20 User’s Guide3. 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 KneecapCradleFigure 7: Fastening the StrapFastening the strap can be performed with one hand although if the other hand is functional, it can also be used.
21Chapter 4 - Daily Use of your NESS L300™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 onaccurately. Locator below the KneecapStrap Handle around the CradleRF Stim Unit Figure 8: Orthosis Fastened in Place
22 User’s GuideTaking the Orthosis OFF1. 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 UnitTurning ON the systemPress the button once. The system starts in standby mode. All display indicators light up for a few seconds while the system performs a self-test, then the button flashes green to indicate that the system is activated.Selecting the ModeTo select the gait mode: After the unit is turned on, press the button once briefly. You shouldhear a beep and the button will start to flash slowly. During stimulationthe button flashes rapidly.To select the training mode:After the unit is turned on, press and hold the button until a beep is heard. The button will start to flash slowly. In addition, the intensityindicator displays a “t” alternating with the intensity level.To return to standby mode:From the gait or training mode, press the button again briefly. You willhear a beep and the button will stop flashing.
23Chapter 4 - Daily Use of your NESS L300™Adjusting the Stimulation Intensity LevelWhen 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.To lift the foot higher:If the foot slightly drags or catches on the floor while walking, the stimulationlevel can be increased by pressing the button.To decrease foot lift:If your foot rises too high while walking or if the stimulation is unpleasant, the intensity level can be reduced by pressing the button. Be sure that your foot does not drag or catch on the floor after reducing the intensity level.When the intensity level is altered, its level appears on the display of the Control Unit and a corresponding beep is emitted.
24 User’s GuideAdjusting the Volume of the Audio IndicationUse 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. 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 re-established.
25Chapter 5 - Care and MaintenanceCare and MaintenanceBatteriesThe batteries should be charged before the first use, after everyday’s use, and after extended storage.Low Battery WarningWhen one of the batteries is low, its indicator light on the Control unit flashesyellow. For more information see the following table:Indication Display Warning Indication Time left (approximately)Low battery in the Control UnitSlow flash accompanied by an audio indicationFour hours Medium flash speed with an audio indication every 10 minutesOne hourRapid flashing with an audio indication every 1 minute Ten minutesLow battery in the RF Stim Unit Slow flash accompanied by an audio indicationFour hours Medium flash speed with an audio indication every 10 minutesOne hourRapid flashing with an audio indication every 1 minute Ten minutesLow battery in the Foot SensorSlow flash accompanied by an audio indicationFourteen daysMedium flash speed with an audio indication every two hoursSeven daysRapid flashing with an audio indication every hourTwo daysRapid flashing and an audio indication every 30 secondsFifteen Minutes5Chapter
26 User’s GuideCharging the BatteriesControl 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.RF Stim Unit charging socketControl Unit charging socket Figure 9: RF Stim Unit and Control Unit Charging Sockets
27Chapter 5 - Care and Maintenance2. 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 .Figure 10: Connecting the Charger
28 User’s Guide3. 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. cv Fully Charged BatteryCharging \Figure 11: Control Unit Charging Indicators Charging Fully Charged BatteryFigure 12: RF Stim Unit Charging Indications
29Chapter 5 - Care and MaintenanceReplacing the BatteriesRF Stim UnitThe RF Stim Unit's battery needs replacing approximately every 2 years by a NESS certified technician.Foot SensorThe 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. Slide the cover back into place and reinstall the screws. Screws Note: If you are unable to replace the battery yourself, your clinician or local watchmaker should be able to assist you.BatteryCover Figure 13: Replacing the Foot Sensor's Battery
30 User’s GuideControl UnitThe 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.Note: If you are unable to replace the battery yourself, your clinician or local watchmaker should be able to assist you.Control Unit ScrewBatteryBattery Cover Figure 14: Replacing the Control Unit's Battery
31Chapter 5 - Care and MaintenanceReplacing 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.Electrode BaseFigure 15: Removing Used Electrode
32 User’s Guide3. Pull a new electrode off the electrode cover. Protective Liner Electrode ElectrodeCover Figure 16: Removing a New Electrode from its Cover4. Attach the new electrode to its base. ElectrodeFigure 17: Attaching a New Electrode
33Chapter 5 - Care and Maintenance5. Remove and discard the protective liners from the electrodes before using the system. Protective LinerFigure 18: Removing the Protective LinersThe electrodes should be slightly moistened approximately once a week.
34 User’s Guide6. Whenever the Orthosis is not on your leg the electrodes should be covered by the cover supplied with the electrodes. Electrode CoverFigure 19: Attaching the Electrode cover
35Chapter 5 - Care and MaintenanceCleaning 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.4. Immerse the Orthosis for an additional 15 minutes into clean lukewarm water.5. Rinse again under running water.6. Let dry in shade (do not hang). The Orthosis should dry fully in 4 to12 hours according to climate and humidity.7. Reattach the RF Stim Unit once the Orthosis is completely dry. Do not use a washing machine or drier.
36 User’s Guide
37Chapter 6 - Replacing and Installing System Components Replacing and Installing System ComponentsReplacing and Registering ComponentsWhen 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:• Control Unit• RF Stim Unit• Foot Sensor1. Make sure the Control Unit is turned OFF.2. Press the and buttons simultaneously and hold them for 3 seconds.3. The Control Unit's display will light up in 2 alternating arches until the registration is complete (See Figure 20).4. If you are registering a new Foot Sensor, you need to apply pressure to the Foot Sensor immediately after entering the registration state. 5. The letter (short for connected) will appear on the Control Unit indicating a successful registration.If the component registered is the RF Stim unit - its status light will turn green.6Chapter
38 User’s Guide6. 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. Registration ErrorRegistration CompleteIn the Process of RegisteringFigure 20: Display while RegisteringMultiple 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.
39Chapter 6 - Replacing and Installing System Components Removing and Installing the RF Stim UnitThe 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.CradleRF Stim UnitFigure 21: Removing the RF Stim Unit from the Orthosis Warning: Do not turn the system on while the RF Stim Unit is out of the cradle
40 User’s GuidePlacing a Foot Sensor in your ShoeThe 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 InsoleAdhesive padFigure 22: Foot Sensor Adhesive Pad in a Shoe3. 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).
41Chapter 6 - Replacing and Installing System Components Foot Image AlignmentPressure SensorFigure 23: Foot Sensor in Place Under Insole4. 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.
42 User’s Guide NESS Logo Faces away from the ShoeClamp on inner rim of ShoeFigure 24: Transmitter in Place (Left Shoe Shown)
43Chapter 7 - AccessoriesAccessoriesThe 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 yourshirt 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. Belt pouch:This small pouch fits on your belt for quick and easy storage of yourControl Unit.Figure 25: Accessories7Chapter
44 User’s Guide
45Chapter 8 - TroubleshootingTroubleshootingWhat 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 theintensity 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. The electrodes may be missing or damaged. If this is the case then install new electrodes according to the section "Replacing Electrodes".3. Put the Orthosis back on your leg, turn the Control Unit ON, and press the Gait mode button.If the problem persists then:4. Check that the RF Stim Unit is installed properly (see the section "Removing and Installing the RF Stim Unit"). If the problem persists then contact your NESS L300™ distributor.8Chapter
46 User’s GuideWhat should I do if…The Control Unit starts to beep, the system stops working, the Control Unit indicators start flashing red in succession andthe 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. After making sure that all the components are present and working, turn the system OFF and back ON. If all components are present and working, apply pressure to the Foot Sensor.If the problem persists contact your NESS L300™ distributor.…one of the component indication lights starts to flash yellow and I hear a beep?The corresponding component's battery is low, and needs charging. If the Foot Sensor's light is flashing - its battery needs to be replaced. (seethe sections "Charging the batteries" and "Replacing the batteries").…one of the component indication lights starts to flash red and I hear a beep?The corresponding component is malfunctioning. Stop using the NESS L300™ and contact your NESS L300™ distributor.
47Chapter 8 - TroubleshootingWhat 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"). If after charging the battery, the problem persists, replace the battery or contact your NESS L300™ distributor.…after charging the batteries, they are still low?Your batteries need replacing (see the section "replacing the batteries"). If the RF Stim Unit's battery needs replacing contact your NESS L300™ distributor.… the electrodes are frayed, peeling, damaged, or falling off the Orthosis?• Replace electrodes (see the section "Replacing Electrodes").• Your electrode bases may be worn, contact your NESS L300™ distributor.
48 User’s GuideWhat 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".If the movement is still unsatisfactory then contact your NESS L300™ distributor.…stimulation happens in consistently while walking, but no fault indication appears.This is a symptom of a technical problem with the Foot Sensor. The Foot Sensor is either worn out or incorrectly placed in the shoe. Reposition or replace the Foot Sensor accordingly.…I receive stimulation in training mode but not in gait mode. Replace the Foot Sensor's battery or Foot Sensor.
49Chapter 9 - SpecificationsSpecificationsControl Unit SpecificationsClassification Internally powered, continuous operationOperation modes Gait, TrainingBattery type Rechargeable AAA NiMH 1.2 V, 750 mAhControlsOn/Off illuminated buttonGait mode illuminated button for changing operation modesIntensity +/- buttons to fine-tune the intensityVolume +/- buttons control buzzer volumeIndicationsThree status LEDs: Control Unit, RF Stim unit and Foot Sensor. Numerical display designates relative stimulation intensityIlluminated buttons designates system operation mode.Buzzer for audible indicationsCarrying In pocket, Neck strap, Wrist strap, Belt pouchDimensionsHeight: 71 mmWidth: 46 mmDepth: 17.5 mmWeight 45 gramsEnvironmentalTransport and storage: 0-35°C (32-95°F)Operating: 0-45°C (32-113°F)Charging: 10-45°C (50-113°F)10% to 85% relative humidity900 hPa to 1060 hPa atmospheric pressure9Chapter
50 User’s GuideRF Stim Unit SpecificationsClassificationInternally powered, continuous operation with type BF applied partsOperating voltage3.7 VBattery typeProprietary rechargeable LiIon (Lithium Ion) 3.7 V, 700 mAhIndications Status (fault, battery, charging) and Stimulation LEDsBuzzer for audible indicationsDimensionsHeight: 76mmWidth: 43mmDepth: 14.5mmWeight 45 gramsEnvironmental Transport and storage: 0-35°C (32-95°F)Operating: 0-45°C (32-113°F)Charging: 10-45°C (50-113°F)10% to 85% relative humidity900hPa to 1060hPa atmospheric pressurePulse ParametersPulse Balanced BiphasicWaveform Symmetric or AsymmetricIntensity 0 - 80 mA, 1mA resolution (positive phase)Max Voltage 120 V
51Chapter 9 - SpecificationsSymmetric AsymmetricPositive phase width 100 µS 200 µS 300 µS 100 µS 200 µS 300 µSNegative phase width 100 µS 200 µS 300 µS 400 µS 800 µS 1200 µSInter-phase interval 50 µS 0Total Pulse duration 250 µS 450 µS 650 µS 500 µS 1000 µS1500 µSMax Load 5000 Ω (Subject to Max Voltage limitation)Pulse repetition rate 15- 45 Hz (5 Hz resolution) Gait ParametersRamp up 0 - 2 seconds, 0.1 second resolutionRamp down 0 - 2 seconds, 0.1 second resolutionDelay 0 - 100% of stance time, 10% resolutionMax duration 4 secondsTraining ParametersOn time 4 - 20 seconds, 1 second resolutionOff time 4 - 60 seconds, 1 second resolutionRamp up 0 - 2 second, 1 second resolutionRamp down 0 - 2 seconds, 1 second resolutionTotal time 1 - 60 minutes
52 User’s GuideOrthosis specificationsOrthosisFabric-polymer Orthosis for single handed electrode relocation Limb size 29 - 51 cm limb circumferenceDimensionsHeight: 135 mmWidth: 100 mmDepth: 125 mmWeight Approximately 150 gramsElectrode specificationsElectrodes Two, 45 mm reinforced hydro gel electrodesNote: Use only electrodes provided by NESS Ltd.Foot Sensor SpecificationsClassification Internally powered, continuous operation with type BF applied partBattery type Lithium coin cell, CR2430, 280 mAhDimensions of the transmitterHeight: 80 mmWidth: 50 mmDepth: 10 mmWeight 35 gramsEnvironmental Transport and storage: 0-35°C (32-95°F)Operating: 0-45°C (32-113°F)10% to 85% relative humidity900 hPa to 1060 hPa atmospheric pressure
53Chapter 9 - SpecificationsPower Supply specifications (Charger)Voltage 5V ± 5%Current1300 mANote: Use only power supply provided/approved by NESS Ltd.Wireless link specificationsFrequency band 2.4 GHz, ISM bandTransmission powerComplies with FCC 15.247 (for US) / ETSI EN300-440 (for Europe) Regulations.
54 User’s Guide
55Chapter 9 - SpecificationsList of SymbolsAttention, See Instructions for UseComplies to United States and Canadian product safety standardsComplies with the European Union medical device directiveSerial NumberClass IIType BF Applied PartNon-Ionizing RadiationAuthorized European RepresentativeDate of manufactureManufacturerThis product must not be disposed of with your other household waste10Chapter

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