Bioness Neuromodulation A Bioness L300-CU-V10 L300 Control Unit User Manual Revision 2

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NESS L300
User Guide
NESS L300 User Guide
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.
ii
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
NESS L300 User Guide
iii
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
iv
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
NESS L300 User Guide
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
vi
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.
NESS L300 User Guide
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.
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 highfrequency 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.
NESS L300 User Guide
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:
When there is a tendency to hemorrhage following acute trauma
or fracture.
Following recent surgical procedures when muscle contraction
may disrupt the healing process.
•
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.
•
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.
NESS L300 User Guide
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.
2. General Overview of your
NESS L300
Components of the NESS L300
The NESS L300 is supplied with the following components:
Control Unit
Orthosis
Orthosis Electronic Module
Foot sensor
Electrodes
Carrying case
User Manual
Charger (supplied separately)
Figure 1: L300 System Components in carrying case
NESS L300 User Guide
The Orthosis
Electrode base
& electrode
Elastic Strap
Locator
Handle
Electronic Module
Cradle
Status light
Stimulation light
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
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.
Status Light
System on
Flashes green
Low battery
Flashes yellow
Charging
Alternating between
yellow and green
Battery fully charged
Constant Green
Malfunction
Constant or flashing
red light
Stimulation applied
Flashes rapid yellow
Stimulation inactive
Flashes slow yellow
Stimulation Light
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.
NESS L300 User Guide
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.
Note
Transmitter
Clip
Pressure Sensor
Figure 3: Foot Sensor
10
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
NESS L300 User Guide
11
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. 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.
NESS L300 User Guide
13
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.
Do not increase the stimulation intensity level set for you by your
clinician by more than two levels without first consulting him or her.
Note
14
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.
NESS L300 User Guide
15
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 1.5
seconds
Self-test at startup
0-9
Intensity level setting
The letter “t” and
intensity digit alternate
Training Mode
Segments of the digit
rotate in a circular
pattern
Charging
Yellow
Red,
yellow and
green
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.
NESS L300 User Guide
17
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
18
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
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.
Before putting on the orthosis make sure to remove
the protective covers from the electrodes.
Note
NESS L300 User Guide
19
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.
Figure 5: Positioning the Leg
20
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. Make sure it remains in place until you fasten the strap
according to one of the methods described below.
NESS L300 User Guide
21
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. 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.
22
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.
NESS L300 User Guide
23
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.
24
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.
Medium speed flash, audio
indication every 10 minutes
Orthosis battery is lowApprox. 1 hours use left.
Rapid Flashing and an audio
indication every 1 minute
Orthosis battery is lowApprox. 10 minutes use left.
Starts to flash slowly
accompanied by an audio
indication.
Control unit battery is lowApprox. 4 hours use left.
Medium speed flash, audio
indication every 10 minutes
Control unit battery is lowApprox. 1 hours use left.
Rapid Flashing and an audio
indication every 1 minute
Control unit battery is lowApprox. 10 minutes use left.
NESS L300 User Guide
25
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. 15 minutes of use left
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.
Figure 9: Control Unit Charger Socket
NESS L300 User Guide
27
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
28
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.
Cover
Tip: If you are unable to replace
the battery yourself, your clinician
or local watchmaker should be
able to assist you
Screw
Battery
Figure 12: Replacing the Foot Sensor’s Battery
NESS L300 User Guide
29
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.
Control Unit
Battery Cover
and Screw
Tip: If you are unable to replace
the battery yourself, your clinician
or local watchmaker should be
able to assist you
Battery
Figure 13: Control Unit and Battery
30
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. Remove the protective cover from the electrode before using the
system. The cover should be put aside and saved, for later use.
NESS L300 User Guide
31
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.
32
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
If the component registered was the orthosis'
electronic module its status light will also turn green.
Note
NESS L300 User Guide
33
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
34
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.
NESS L300 User Guide
35
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.
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.
36
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.
NESS L300 User Guide
37
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.
38
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.
Color
NESS L300 User Guide
Radio
communication
lost
Bad electrode
contact with the
calf.
Flash
Meaning
Flashing
Malfunctiondangerous to the
hardware
Constant
Fault-dangerous
to the owner or
charge
malfunction
Flashing
Low battery
Red
Yellow
Meaning
39
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.
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.
After charging your
batteries, they are still low.
40
Replace with new electrodes according
to the section "Replacing Electrodes"
Your batteries need replacing.
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.
If there is still no ankle movement contact
your NESS L300 distributor.
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.
Cease use of system and contact your
NESS L300 distributor.
41
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. 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.
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.
NESS L300 User Guide
43
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
Indications
Carrying
Dimensions
Weight
44
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
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
Wrist strap, Neck strap, Pouch
Height: 71mm
Width: 46mm
Depth: 17.5mm
45 grams
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
Operating voltage :
Classification
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
Indications
At least 1 week between charges
: 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
NESS L300 User Guide
Asymmetric
45
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
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
46
Attached to a cradle in the NESS L300 Orthosis
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.
NOTE: First remove stimulator
NOTE: DO NOT use drier
Height: 160mm
Width: 100mm
Depth: 125mm
Approx 160 grams
NESS L300 User Guide
47
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
Weight
Height: 80mm
Width: 50mm
Depth: 10mm
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
48
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).
NESS L300 User Guide
49
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

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