NESS L300 User Guide NESS L300 User Guide i
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.
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.
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.........................
REPLACING THE BATTERIES ....................................................................29 Orthosis Electronic Module...................................................................29 Foot Sensor..........................................................................................29 Control Unit ..........................................................................................30 REPLACING ELECTRODES .......................................................................
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 .......................
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.
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.
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.
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.
• 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.
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.
2.
The Orthosis Electrode base & electrode Elastic Strap Locator Handle Electronic Module Cradle Status light Stimulation light Figure 2: The Orthosis 8 • 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.
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.
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. The foot sensor should be placed only under the foot designated by the clinician.
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.
Control Unit Buttons and Display Neck Strap Hole Volume Adjustment buttons ON/OFF Button Control Unit indicator light Trigger Mode Button Intensity Indicator Intensity Level Foot Sensor Indicator Light Buttons Figure 4: Control unit buttons and display 12 Orthosis Indicator Light
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.
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.
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.
Control Unit Display and Audio Indications Visual Display On/Off Button Trigger mode button All display lights Intensity indicator 16 Color Flash Meaning Green Slow System is activated Slow System in gait or training mode but not stimulating Rapid System in gait or training mode and stimulating Alternating colors one after the other for 1.
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.
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.
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.
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. This point under your knee is where the locator (see fig. 2) of the orthosis fits.
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. Locator Elastic strap is on the outside of the leg before fastening. Handle 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.
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. Locator just below the kneecap Attaching Point of Cradle Figure 7: Fastening the Strap (First Method) 2.
Figure 8 shows the orthosis when it is placed correctly on the right leg. Locator just below the kneecap Handle seated on attaching point of the cradle Electronic Module Figure 8: Orthosis Fastened in Place "Bad electrode contact" indication Note 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.
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.
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: Low Battery in the Orthosis Low Battery in the Control unit Starts to flash slowly accompanied by an audio indication. Orthosis battery is lowApprox. 4 hours use left.
Low Battery in the Foot sensor 26 Starts to flash slowly accompanied by an audio indication. Foot sensor battery is lowApprox. 14 days of use left. Medium speed flash, audio indication every 2 hours. Foot sensor battery is lowApprox. 7 days of use left. Rapid Flashing and an audio indication every hour Foot sensor battery is lowApprox. 2 days of use left. Rapid Flashing and an audio indication every 30 seconds Foot sensor battery is lowApprox.
Charging the Batteries Control Unit and Orthosis Only the Control and Orthosis units' batteries are rechargeable. Note 1. Open the cover of the charger socket at the bottom of the control unit as in Figure 9.
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.
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).
Control Unit The control unit’s battery is a rechargeable AAA battery and needs replacing approximately every 2 years. The batteries must be charged before the first use, after every day’s use, and after extended storage. Note 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.
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. The NESS L300 should be used only with electrodes supplied by NESS Ltd. Attention 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.
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.
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.
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.
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.
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. Transmitter Attaching Clip Pressure Sensor 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.
NESS Logo faces away from foot 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.
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.
8. Troubleshooting To locate your local NESS L300 distributor, call 972-9-7485738 or visit our website: www.nessltd.com Error light indications Indicators All three Component lights on the control unit Color Red Red Indicator Orthosis, Foot sensor or Control unit indication light Flash Cycles between Control unit, Orthosis, and Foot Sensor, also “E” appears on digital display All the component lights flash simultaneously. “E” flashes on the digital display.
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. Make sure the battery is charged (see the The Control Units' display section "Charging the batteries" for does not light up when you instructions). switch ON the Control If, after charging the battery, the Mode Unit. display still does not appear, contact your NESS L300 distributor.
Problem No error indications appear, but there is no movement of the ankle. I feel stimulation from the orthosis, but my foot does not respond in a satisfactory way. System malfunction indication appears. NESS L300 User Guide Solution 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.
Problem The "bad electrode contact" indication appears. 42 Solution 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.
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.
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.
IPX1 Water protection 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 Internally powered, continuous operation with type BF applied parts 3.7 V Operating voltage : Classification Operation current : 70 mA Battery type : Rechargeable Prismatic LiIon (Lithium Ion) 3.
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 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 0 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.
Weight Height: 74mm Width: 43mm Depth: 15mm 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 Dimensions Orthosis specifications Orthosis Limb size Maintenance Dimensions Weight Fabric-Polymer orthosis for electrode relocation and single handed attachment 28 – 50 cm limb circumference Immerse in cold water when needed and let dry in free air.
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.
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).
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 50
