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 Guide
Part No: B0001002 Rev 1
II
User Guide Copyright
© 2006 NESS Ltd.
All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any
language or any computer language, in any form or by any third party, without the prior written permission of NESS Ltd.
Trademarks
NESS is a trademark of NESS Ltd.
NESS L300™ is a trademark of NESS Ltd.
Disclaimer
NESS Ltd. 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 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™ 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, Israel
Tel: (972) 9-748-5738 Fax: (972) 9-748-5740, Email: ness@ness.co.il, Website: www.nessltd.com
European Distributor
Ness Europe B.V, Zadelmakerstraat 53
2984 CC Ridderkerk, The Netherlands
Tel: 31-180-481600 Fax: 31-180-463152
Email: ness@ness.nl
Website: www.ness.nl
U.S. Distributor
Bioness Inc. 25134 Rye Canyon Loop Suite 300
Santa Clarita, California 91355
Tel: (800) 211-9136 Fax: (661) 362-4851
Email: info@bionessinc.com
Website: www.bionessinc.com
III
Contents
1. Introduction to your NESS L300™................................................ 1
Indications For Use........................................................................... 1
Advanced Technology in Rehabilitation............................................ 1
For Your Health and Safety............................................................... 2
2. General Overview of your NESS L300
™.............................................. 7
Components of the NESS L300™.................................................... 7
The Orthosis..................................................................................... 8
Indicator lights on the RF Stim Unit............................................ 9
The Foot Sensor............................................................................... 10
The Control Unit................................................................................ 11
Control Unit Buttons.................................................................... 12
Control Unit Display and Audio Indication................................... 13
3. Operating Modes............................................................................. 15
Standby Mode................................................................................... 15
Gait Mode.......................................................................................... 15
Training Mode................................................................................... 15
4. Daily Use of your NESS L300™..................................................... 17
Activating and Using the System...................................................... 17
Positioning the Orthosis on your leg................................................. 18
IV
Taking the Orthosis off....................................................................... 22
Operating the Control Unit.................................................................22
5. Care and Maintenance.................................................................... 25
Batteries............................................................................................ 25
Low Battery Warning........................................................................ 25
Charging the Batteries...................................................................... 26
Replacing the Batteries.................................................................... 29
Replacing Electrodes........................................................................ 31
Cleaning your NESS L300™............................................................ 35
6. Replacing and Installing System Components............................ 37
Replacing and Registering Components........................................... 37
Removing and Installing the RF Stim Unit......................................... 39
Placing a Foot Sensor in your Shoe................................................. 40
7. Accessories.................................................................................... 43
8. Troubleshooting............................................................................. 45
9. Specifications................................................................................. 49
10. List of Symbols................................................................................ 55
V
List of Figures
Figure 1: NESS L300™ System Components .......................................7
Figure 2: The Orthosis ...........................................................................8
Figure 3: The Foot Sensor ...................................................................10
Figure 4: The Control Unit ................................................................... 11
Figure 5: Recommended Knee Angle for Orthosis Application ............18
Figure 6: Placing the Orthosis on the Leg ...........................................19
Figure 7: Fastening the Strap ..............................................................20
Figure 8: Orthosis Fastened in Place .................................................21
Figure 9: RF Stim Unit and Control Unit Charging Sockets .................26
Figure 10: Connecting the Charger .......................................................27
Figure 11: Control Unit Charging Indicators ..........................................28
Figure 12: RF Stim Unit charging Indicators ..........................................28
Figure 13: Replacing the Foot Sensor’s Battery ....................................29
Figure 14: Replacing the Control Unit's Battery .....................................30
Figure 15: Removing Used Electrodes ..................................................31
VI
Figure 16: Removing a New Electrode from its Cover ...........................32
Figure 17: Attaching a New Electrode ...................................................32
Figure 18: Removing the Protective Liners ............................................33
Figure 19: Attaching the Electrode Cover ..............................................34
Figure 20: Display while Registering .....................................................38
Figure 21: Removing the RF Stim Unit from the Orthosis .....................39
Figure 22: Foot Sensor Adhesive Pad in a S
hoe
...................................40
Figure 23: Foot Sensor in Place under Insole .......................................41
Figure 24: Transmitter in Place (Left Shoe Shown) ...............................42
Figure 25: Accessories ..........................................................................45
1
Chapter 1 - Introduction
Introduction to your NESS L300
TM
Indications For Use
The NESS L300™ is intended to provide ankle dorsiflexion in individuals
with foot drop following an upper motor neuron injury or disease. During the
swing phase of gait, the NESS L300™ electrically stimulates muscles in
the affected leg to provide dorsiflexion of the foot; thus, it may improve the
individual’s gait. 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 Rehabilitation
Central 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
1
Chapter
2User’s Guide
integrated electrodes. While walking, the Foot Sensor detects whether the
foot is in the air or on the ground and transmits that information to the rest
of the system which accordingly activates the foot.
The wireless Control Unit displays information regarding the system's status
and manages the various system components.
The NESS L300TM system incorporates cutting edge technology and
sophisticated ergonomics in order to improve your walking and quality of
life.
Please read this guide carefully in order to maximize the benefits provided
by this advanced system.
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.
• Patients with an implanted electronic metallic device (for example a
cardiac pacemaker or defibrillator) should not be subjected to stimulation
unless specialist medical opinion has first been obtained.
3
Chapter 1 - Introduction
Warnings
• The long-term effects of chronic electrical stimulation are unknown.
• The Orthosis should not be applied over swollen, infected, or inflamed areas
or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
• Simultaneous connection of the L300™ to the patient and to high-frequency
surgical equipment may result in burns at the site of the stimulator
electrodes and possible damage to the RF Stim Unit of the Orthosis.
• 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 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 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.
5
Chapter 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 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.
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.
• Skin irritations and burns have been reported with the use of powered
muscle stimulators.
• Any other unanticipated reaction.
6User’s Guide
Radio Communication Information
This device complies with Part 15 of the FCC Rules. Operation is subject to
the following conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference
that may cause undesired operation.
Parts of the NESS L300™ communicate via radio communication and
have been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. 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 expressly
approved by NESS Ltd. could void the user’s authority to
operate the equipment.
7
Chapter 2 -
General Overview of your
NESS L300™
General Overview of your NESS L300TM
Components of the NESS L300™
The NESS L300™ is supplied with the following components:
• Control Unit
• Orthosis & RF Stim Unit
• Foot Sensor & Adhesive pads
• Electrodes
• Charger
• User's Guide
• Carrying case
Charger
Control Unit
User Guide
Foot Sensor
Electrodes
Orthosis
Figure 1: NESS L300™ System Components
2
Chapter
8User’s Guide
The Orthosis
Electrode
Locator
Strap
Handle
Cradle
Status Light
Stimulation Light
RF Stim Unit
Strap
Electrode 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.
9
Chapter 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 easily
replaced by the user without changing their positions.
Indicator lights on the RF Stim Unit
Indicator lights on the RF Stim Unit displays the unit's status and when
stimulation occurs.
Indicator Display Display Pattern Description
Status Light Flashes green System on
Flashes yellow Low battery
Alternating between
yellow and green Charging
Constant Green Battery fully charged
Stimulation
Light Flashes slowly yellow Stimulation inactive
Flashes rapid yellow Stimulation applied
10 User’s Guide
The Foot Sensor
The Foot Sensor (Figure 3) detects whether the foot is on the ground or in
the air and transmits radio signals to the RF Stim Unit according to which
stimulation is activated.
The Foot Sensor consists of a pressure sensor worn underneath the insole
of the shoe and a small transmitter attached to the upper edge of the shoe
by a clamp.
There is no need to detach the Foot Sensor between uses.
The 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.
Transmitter
Clamp
Pressure Sensor
Figure 3: The Foot Sensor
11
Chapter 2 -
General Overview of your
NESS L300™
The Control Unit
The Control unit (see figure 4) enables the user to activate/deactivate the
system, select the operation mode, fine-tune the stimulation intensity and
receive information regarding the system by visual and audio indicators.
During operation, the Control unit maintains communication with the RF
Stim Unit in the Orthosis and Foot Sensor.
It can be carried in a pocket, belt pouch or around the neck using the neck
strap supplied.
The Control Unit is powered by a single rechargeable AAA battery.
On/Off Button
Gait mode
Button
Intensity
adjustment
Buttons
Intensity
Indicator
Volume
Buttons
Control Unit
Indicator
Foot Sensor
Indicator
RF Stim Unit
Indicator
Figure 4: The Control Unit
12 User’s Guide
Control Unit Buttons
Control Unit
Operating Button
Description
ON/OFF
Turns the Control Unit
ON and OFF
Gait mode Selects Gait, Training
or Standby Mode
Volume
Adjustment
Adjusts the volume of
the audio indications
Intensity Adjusts the intensity of
stimulation
13
Chapter 2 -
General Overview of your
NESS L300™
Control Unit Display and Audio Indications
Visual Indications
Control Unit Display Display Pattern Description
Flashes Green System is ON
Flashes Yellow
SLOWLY
System in Gait or Training
mode, but not Stimulating
Flashes Yellow
RAPIDLY
System in Gait or Training
mode and Stimulating
Displays 0 - 9 Intensity level
Alternates “t” and
the intensity level Training mode
One of the Indications
Flashes Yellow
Low Battery
Rotating Circle
Charging
Horizontal Line
Fully Charged
14 User’s Guide
Audio indications
The audio alert beeps when:
• The system is first turned ON.
• A button is pressed.
• Low battery.
• There is a malfunction accompanied by a visual indication.
Error indications
Display Display Flash Meaning
The RF Stim Unit's
Indicator is Constantly
Red and “E” appears on
the Intensity Indicator
Bad Electrode
Contact
All indicators flash Red
and “E” flashes on the
Intensity Indicator
Radio Communication
failure between the
Control Unit and RF
Stim Unit
The Foot Sensor's
Indicator is Constantly
Red and the Intensity
value flashes
Foot Sensor not found
by the system
One of the Indicators is
Constantly Red
Component
Malfunction
15
Chapter 3 - Operating Modes
Operating Modes
Standby mode
The system is ON, and waiting for commands. Stimulation is not applied in
Standby mode.
Gait mode
Select this mode for walking. In Gait mode the stimulation is synchronized
by the Foot Sensor, in order to achieve foot lifting while the foot is in the air
and foot rest while the foot is on the ground.
Training mode
Select this mode for muscle training while you are sitting or lying down. 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.
3
Chapter
17
Chapter 4 - Daily Use of your NESS L300™
Daily Use of your NESS L300
TM
Activating and Using the System
1. Position the Orthosis on your leg.
2. Turn ON the Control unit.
3. Select either GAIT or TRAINING mode.
4. Begin walking or let the training mode exercise your leg.
Before using the system make sure the Foot Sensor is installed.
If not install it according to the section “Placing the Foot Sensor in
your Shoe”.
4
Chapter
18 User’s Guide
Positioning the Orthosis on your leg
1. While seated, slightly extend your leg as seen in Figure 5. This causes
the outline of the kneecap to be clearly defined. It may be helpful to
place your foot on a small stool or footrest.
The point under your
Kneecap where the
Locator of the Orthosis
Should fit.
Figure 5: Recommended Knee Angle for Orthosis Application
19
Chapter 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 Handle
Locator
Figure 6: Placing the Orthosis on the Leg
After the Orthosis is in position, push the Orthosis against the leg. The
Orthosis will gently grip the leg.
20 User’s Guide
3. To fasten the Orthosis strap, grasp the handle of the elastic strap with
the fingers of the opposite hand (see Figure 7), then hook your thumb
around the cradle in order to hold the Orthosis in place while you pull the
handle around the cradle.
Locator just
below the
Kneecap
Cradle
Figure 7: Fastening the Strap
Fastening the strap can be performed with one hand although if
the other hand is functional, it can also be used.
21
Chapter 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 on
accurately.
Locator below the
Kneecap
Strap Handle
around the Cradle
RF Stim Unit
Figure 8: Orthosis Fastened in Place
22 User’s Guide
Taking the Orthosis OFF
1. Make sure the system is OFF.
2. Unhook the strap handle from the cradle and take the Orthosis off.
3. Place the electrode cover over the electrodes.
4. Charge the Control Unit and RF Stim Unit's batteries fully at the end of
your daily use (see Charging the Batteries).
Operating the Control Unit
Turning ON the system
Press the button once. The system starts in standby mode. 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 Mode
To select the gait mode:
After the unit is turned on, press the button once briefly. You should
hear a beep and the button will start to flash slowly. During stimulation
the 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 intensity
indicator 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 will
hear a beep and the button will stop flashing.
23
Chapter 4 - Daily Use of your NESS L300™
Adjusting the Stimulation Intensity Level
When the Control Unit is turned on, the stimulation intensity level starts
at level 5, which is the default stimulation intensity level. Normally there is
no need to adjust the stimulation intensity; however, it may be necessary
while walking on different surfaces or with various shoes. When necessary,
the stimulation level can be manually adjusted by pressing the or
buttons on the Control Unit.
If the intensity is reduced to 0, no stimulation will be applied.
To lift the foot higher:
If the foot slightly drags or catches on the floor while walking, the stimulation
level 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 Guide
Adjusting the Volume of the Audio Indication
Use the buttons to adjust the volume:
• Each time one of the buttons is pressed the volume increases or
decreases. You will hear a corresponding beep at the volume you
select.
• Reducing the volume to the minimal setting mutes the Control Unit.
• When you turn the system off, the volume level is saved unless the
volume is set to "mute", in which case the volume level is automatically
adjusted to the default level.
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.
25
Chapter 5 - Care and Maintenance
Care and Maintenance
Batteries
The batteries should be charged before the first use, after every
day’s use, and after extended storage.
Low Battery Warning
When one of the batteries is low, its indicator light on the Control unit flashes
yellow. For more information see the following table:
Indication Display Warning Indication Time left
(approximately)
Low battery in the
Control Unit
Slow flash accompanied by an
audio indication
Four hours
Medium flash speed with an audio
indication every 10 minutes
One hour
Rapid flashing with an audio
indication every 1 minute Ten minutes
Low battery in the
RF Stim Unit
Slow flash accompanied by an
audio indication
Four hours
Medium flash speed with an audio
indication every 10 minutes
One hour
Rapid flashing with an audio
indication every 1 minute Ten minutes
Low battery in the
Foot Sensor
Slow flash accompanied by an
audio indication
Fourteen days
Medium flash speed with an audio
indication every two hours
Seven days
Rapid flashing with an audio
indication every hour
Two days
Rapid flashing and an audio
indication every 30 seconds
Fifteen
Minutes
5
Chapter
26 User’s Guide
Charging the Batteries
Control Unit and RF Stim Unit
• Both the Control Unit's and RF Stim Unit's batteries are
rechargeable.
• Remove Orthosis from leg while charging.
1. Open the cover of the charging socket at the bottom of the Control Unit
and at the top of the RF Stim Unit as seen in Figure 9.
RF Stim Unit
charging socket
Control Unit
charging socket
Figure 9: RF Stim Unit and Control Unit Charging Sockets
27
Chapter 5 - Care and Maintenance
2. Connect the charger cable to the Control Unit and to the RF Stim
Unit as seen in Figure 10 and plug into the wall socket. A rotating
circular icon will appear on the Control Unit's display and the
status light on the RF Stim Unit will start flashing alternating
yellow/green .
Figure 10: Connecting the Charger
28 User’s Guide
3. Leave the charger connected until the appears on the Control Unit's
display and the RF Stim Unit's status light turns a constant green ,
indicating a full charge. The charging process should last approximately
3 hours.
cv
Fully Charged
Battery
Charging
\
Figure 11: Control Unit Charging Indicators
Charging
Fully Charged
Battery
Figure 12: RF Stim Unit Charging Indications
29
Chapter 5 - Care and Maintenance
Replacing the Batteries
RF Stim Unit
The RF Stim Unit's battery needs replacing approximately every 2 years by
a NESS certified technician.
Foot Sensor
The battery in the Foot Sensor is not rechargeable, and needs replacing
approximately every 6 months.
To install a new battery (Lithium coin cell, CR2430):
1. Unscrew the two screws from the battery cover.
2. Slide the cover out.
3. Remove the old battery.
4. Insert the new battery (The “+” should face outwards).
5. 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.
Battery
Cover
Figure 13: Replacing the Foot Sensor's Battery
30 User’s Guide
Control Unit
The Control Unit’s battery is a rechargeable AAA battery and needs replacing
approximately every 2 years.
1. Remove the screw from the battery cover on the back of the Control Unit.
(The screw may be under an ID sticker-gently peel it off the screw).
2. Remove the battery cover.
3. Remove the old battery.
4. Insert a new battery (rechargeable AAA), according to the polarity marks
in the battery socket.
5. Slide the cover back into place.
6. Tighten the screw.
Note: If you are unable
to replace the battery
yourself, your clinician or
local watchmaker should
be able to assist you.
Control Unit
Screw
Battery
Battery Cover
Figure 14: Replacing the Control Unit's Battery
31
Chapter 5 - Care and Maintenance
Replacing Electrodes
• The electrodes should be replaced at least every 2 weeks. It is
recommended to replace the electrodes regularly in order to maintain
optimal efficiency.
The NESS L300™ should be used only with electrodes supplied
by NESS Ltd.
1. Make sure the system is OFF.
2. Pull the used electrodes gently out of their bases (See Figure 15). Take
care not to detach the electrode bases from the Orthosis.
Electrode Base
Figure 15: Removing Used Electrode
32 User’s Guide
3. Pull a new electrode off the electrode cover.
Protective Liner
Electrode
Electrode
Cover
Figure 16: Removing a New Electrode from its Cover
4. Attach the new electrode to its base.
Electrode
Figure 17: Attaching a New Electrode
33
Chapter 5 - Care and Maintenance
5. Remove and discard the protective liners from the electrodes before
using the system.
Protective Liner
Figure 18: Removing the Protective Liners
The electrodes should be slightly moistened approximately
once a week.
34 User’s Guide
6. Whenever the Orthosis is not on your leg the electrodes should be
covered by the cover supplied with the electrodes.
Electrode Cover
Figure 19: Attaching the Electrode cover
35
Chapter 5 - Care and Maintenance
Cleaning your NESS L300™
All parts may be cleaned by carefully wiping with a damp cloth.
Electrical components are not waterproof, so do not immerse them in
water. The Orthosis is the only component that can be immersed in water
for cleaning.
When the Orthosis needs a thorough cleaning:
1. Remove the RF Stim Unit (see "Removing and Installing the RF Stim
Unit" section).
2. Immerse the Orthosis for 30 minutes into lukewarm water with a small
amount of mild detergent.
3. Rinse thoroughly under running water.
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
37
Chapter 6 - Replacing and Installing System
Components
Replacing and Installing System
Components
Replacing and Registering Components
When one or more of the NESS L300™ electronic components are replaced,
it needs to be electronically registered to ensure radio communication
between the components of the system. New components that requires
registration are:
• Control Unit
• RF Stim Unit
• Foot Sensor
1. 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.
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Chapter
38 User’s Guide
6. The letter “E” (short for Error) will appear if the registration was
unsuccessful. In such case, repeat steps 1-3. If the problem persists
see the troubleshooting section.
Registration
Error
Registration
Complete
In the Process of
Registering
Figure 20: Display while Registering
Multiple Foot Sensors can be registered with one L300™ system,
allowing you to use several pairs of shoes without the need to
transfer your Foot Sensor from one shoe to another.
39
Chapter 6 - Replacing and Installing System
Components
Removing and Installing the RF Stim Unit
The RF Stim Unit should be removed only for the purpose of cleaning the
Orthosis or for its replacement.
Figure 21 shows how to detach the RF Stim Unit from the Orthosis cradle.
1. Release the RF Stim Unit from the cradle by pulling its upper edge out.
2. To reinstall the RF Stim Unit, insert the bottom prongs into the lower part
of the cradle and push its upper part gently into the cradle until a snap
sound is heard.
Cradle
RF Stim Unit
Figure 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 Guide
Placing a Foot Sensor in your Shoe
The Foot Sensor should be placed under an insole.
1. Remove the insole from the shoe.
2. Stick an adhesive pad (included in the kit) in your shoe in the area directly
below your heel.
Shoe Insole
Adhesive pad
Figure 22: Foot Sensor Adhesive Pad in a Shoe
3. Place the Foot Sensor in the shoe, onto the adhesive pad with the wire
pointing towards the toe area (also see the foot image on the sensor for
correct alignment).
41
Chapter 6 - Replacing and Installing System
Components
Foot Image
Alignment
Pressure Sensor
Figure 23: Foot Sensor in Place Under Insole
4. Insert the insole into the shoe to cover the sensor, making sure any
excess wire is tucked out of the way under the insole.
5. Attach the transmitter of the Foot Sensor to the inner rim of the shoe
using the clamp. The NESS logo on the transmitter should face away
from the shoe.
42 User’s Guide
NESS Logo
Faces away
from the Shoe
Clamp on
inner rim
of Shoe
Figure 24: Transmitter in Place (Left Shoe Shown)
43
Chapter 7 -
Accessories
Accessories
The NESS L300™ comes with accessories that are designed to help you avoid
the inconvenience and distraction of holding your Control Unit.
1. Neck strap (supplied):
The neck strap enables you to hang the Control Unit around your neck.
If you find it more convenient you may insert the Control Unit into your
shirt pocket.
2. Wrist strap (supplied):
The wrist strap allows you to hang the Control Unit from your hand, or to
pull it out of a pocket or pouch easily.
3. Belt pouch:
This small pouch fits on your belt for quick and easy storage of your
Control Unit.
Figure 25: Accessories
7
Chapter
44 User’s Guide
45
Chapter 8 -
Troubleshooting
Troubleshooting
What should I do if…
…I hear a beep, the RF Stim Unit's indicator on the Control Unit
turns
red and the letter "E" appears
on the
intensity display?
This is a symptom of Bad Electrode Contact. To resolve this follow
these steps:
1. Turn OFF the Control Unit.
2. Remove the Orthosis from your leg.
• Make sure the electrode liner is removed and there is no
interference to the contact between the electrodes and the skin.
• Make sure that the electrodes are installed properly. 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.
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Chapter
46 User’s Guide
What should I do if…
The Control Unit starts to beep, the system stops working, the Control
Unit indicators start flashing red in succession and
the letter "E" flashes on the intensity display?
This is a symptom of Radio Communication Failure. Make sure that all
the components are in radio range of each other and their batteries full.
The system will not work if all components aren’t present or if one of the
components isn’t working. 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. (see
the 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.
47
Chapter 8 -
Troubleshooting
What should I do if…
…during charging the letter "E" appears on the Control Unit display?
An error occurred while charging. Try to reconnect the charger cable. If this
doesn’t help replace the battery or contact your NESS L300™ distributor.
… the Control Unit's display does not light up when I switch it ON?
Make sure that the Control unit's battery is charged (see the section
"Charging the batteries"). 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 Guide
What should I do if…
...My NESS L300™ is stimulating, but there is no ankle movement or
the foot does not move in a satisfactory way.
This is a symptom of inaccurate positioning of the Orthosis on the
calf. To resolve this follow these steps:
1. Turn OFF the system.
2. Take the Orthosis off your leg.
3. Reposition the Orthosis on your leg while making sure it is placed
accurately, as described in the section "Putting on the Orthosis".
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.
49
Chapter 9 -
Specifications
Specifications
Control Unit Specifications
Classification Internally powered, continuous operation
Operation modes Gait, Training
Battery type Rechargeable AAA NiMH 1.2 V, 750 mAh
Controls
On/Off illuminated button
Gait mode illuminated button for changing operation modes
Intensity +/- buttons to fine-tune the intensity
Volume +/- buttons control buzzer volume
Indications
Three status LEDs: Control Unit, RF Stim unit and Foot
Sensor.
Numerical display designates relative stimulation intensity
Illuminated buttons designates system operation mode.
Buzzer for audible indications
Carrying In pocket, Neck strap, Wrist strap, Belt pouch
Dimensions
Height: 71 mm
Width: 46 mm
Depth: 17.5 mm
Weight 45 grams
Environmental
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 humidity
900 hPa to 1060 hPa atmospheric pressure
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Chapter
50 User’s Guide
RF Stim Unit Specifications
Classification
Internally powered, continuous operation with type BF applied
parts
Operating
voltage
3.7 V
Battery type
Proprietary rechargeable LiIon (Lithium Ion) 3.7 V, 700 mAh
Indications Status (fault, battery, charging) and Stimulation LEDs
Buzzer for audible indications
Dimensions
Height: 76mm
Width: 43mm
Depth: 14.5mm
Weight 45 grams
Environmental
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 humidity
900hPa to 1060hPa atmospheric pressure
Pulse Parameters
Pulse Balanced Biphasic
Waveform Symmetric or Asymmetric
Intensity 0 - 80 mA, 1mA resolution (positive phase)
Max Voltage 120 V
51
Chapter 9 -
Specifications
Symmetric Asymmetric
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
Inter-phase
interval 50 µS 0
Total Pulse
duration 250 µS 450 µS 650 µS 500 µS 1000
µS
1500
µS
Max Load 5000 Ω (Subject to Max Voltage limitation)
Pulse repetition
rate 15- 45 Hz (5 Hz resolution)
Gait Parameters
Ramp up 0 - 2 seconds, 0.1 second resolution
Ramp down 0 - 2 seconds, 0.1 second resolution
Delay 0 - 100% of stance time, 10% resolution
Max duration 4 seconds
Training Parameters
On time 4 - 20 seconds, 1 second resolution
Off time 4 - 60 seconds, 1 second resolution
Ramp up 0 - 2 second, 1 second resolution
Ramp down 0 - 2 seconds, 1 second resolution
Total time 1 - 60 minutes
52 User’s Guide
Orthosis specifications
Orthosis
Fabric-polymer Orthosis for single handed electrode relocation
Limb size 29 - 51 cm limb circumference
Dimensions
Height: 135 mm
Width: 100 mm
Depth: 125 mm
Weight Approximately 150 grams
Electrode specifications
Electrodes Two, 45 mm reinforced hydro gel electrodes
Note: Use only electrodes provided by NESS Ltd.
Foot Sensor Specifications
Classification Internally powered, continuous operation with type BF
applied part
Battery type Lithium coin cell, CR2430, 280 mAh
Dimensions of
the transmitter
Height: 80 mm
Width: 50 mm
Depth: 10 mm
Weight 35 grams
Environmental
Transport and storage: 0-35°C (32-95°F)
Operating: 0-45°C (32-113°F)
10% to 85% relative humidity
900 hPa to 1060 hPa atmospheric pressure
53
Chapter 9 -
Specifications
Power Supply specifications (Charger)
Voltage 5V ± 5%
Current
1300 mA
Note: Use only power supply provided/approved by NESS
Ltd.
Wireless link specifications
Frequency band 2.4 GHz, ISM band
Transmission
power
Complies with FCC 15.247 (for US) / ETSI EN300-440 (for
Europe) Regulations.
54 User’s Guide
55
Chapter 9 -
Specifications
List of Symbols
Attention, See Instructions for Use
Complies to United States and
Canadian product safety standards
Complies with the European Union
medical device directive
Serial Number
Class II
Type BF Applied Part
Non-Ionizing Radiation
Authorized European Representative
Date of manufacture
Manufacturer
This product must not be disposed of
with your other household waste
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Chapter
56 User’s Guide