Bioness Neuromodulation A Bioness L3P-N-CU-V10 L300 Plus Control Unit User Manual manual1

Bioness Neuromodulation ltd. A Bioness Inc Company L300 Plus Control Unit manual1

Contents

manual1

NESS L300 Plus System
User’s Guide
Rx Only
II
NESS L300 Plus
User’s Guide Copyright
© 2010, Bioness Inc
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 Bioness Inc.
Trademarks
NESS®, NESS L300™, NESS L300 Plus™ Intelli-Gait™, Intelli-Sense Gait Sensor™, Bioness®, the Bioness
Logo and LiveOn™ are trademarks of Bioness Inc. | www.bioness.com | Rx Only
Use of the symbols ® and ™ herein refers to the registration status of trademarks in the U.S. only. These
trademarks may also be registered in other countries.
Patents Pending
Aspects of this device are covered by several patents and patent applications.
Disclaimer
Bioness Inc and its affiliates 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 Bioness Inc products. Bioness Inc 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 Plus, care should be
taken to dispose of those parts in the correct manner; where applicable, parts should be recycled.
For
more detailed information regarding these recommended procedures, please contact Bioness Inc.
Bioness
Inc is committed to continuously seeking and implementing the best possible manufacturing procedures and
servicing routines.
Worldwide Corporate Office
Bioness Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: 800-211-9136
Email: info@bioness.com
Website: www.bioness.com
Manufactured by
Bioness Neuromodulation Ltd.
A Bioness Inc Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
Bioness Customer Support: Telephone: (800) 211-9136, Option 2; or (661) 362-4850, Option 2.
III
Contents
Chapter 1: Introduction ........................................................................ 1
Chapter 2: For Your Health and Safety ............................................... 3
Indications for Use ............................................................................................ 3
Contraindications .............................................................................................. 3
Warnings .......................................................................................................... 4
Precautions ....................................................................................................... 4
Adverse Reactions ........................................................................................... 7
Skin Care Guidelines ........................................................................................ 8
Chapter 3: Environmental Conditions that Affect Use ...................... 11
Radio Frequency (RF) Communication ............................................................ 11
Conformity Certification .............................................................................. 12
Travel ................................................................................................................ 12
Chapter 4: Your NESS L300 Plus System Kit ..................................... 13
Contents ........................................................................................................... 13
System Components .................................................................................. 13
L300 Accessories ....................................................................................... 14
L300 Plus Accessories ............................................................................... 16
L300 Plus Upgrade Kit ...................................................................................... 17
Contents ..................................................................................................... 17
Chapter 5: System Components and Accessories............................ 19
L300 Functional Stimulation (FS) Cuff ............................................................. 19
Locator ........................................................................................................ 20
RF Stim Unit Cradle .................................................................................... 20
Strap ........................................................................................................... 20
Electrode Bases and Surface Electrodes .................................................. 20
L300 RF Stim Unit ............................................................................................ 21
IV
NESS L300 Plus
Thigh FS Cuff .................................................................................................. 23
Distal and Proximal Panels ......................................................................... 24
Elongation Bar ............................................................................................ 24
Straps ......................................................................................................... 24
Surface Electrodes ..................................................................................... 24
Thigh RF Stim Unit ........................................................................................... 25
Gait Sensor ....................................................................................................... 27
L300 Plus Control Unit ...................................................................................... 29
Control Unit Operating Buttons ................................................................... 30
Control Unit Operating Modes .................................................................... 30
Control Unit Digital Display and Indicator Lights ........................................ 32
Control Unit Audio Indicators ...................................................................... 34
L300 Accessories ............................................................................................. 35
L300 Hydrogel Electrodes .......................................................................... 35
L300 Hydrogel Electrode Bases ................................................................. 36
L300 Cloth Electrodes ................................................................................ 37
L300 Cloth Electrode Bases ....................................................................... 38
Wrist Strap, Neck Strap, and Belt Pouch .................................................... 39
Replacement Battery, Gait Sensor ............................................................. 40
Gait Sensor Pads ....................................................................................... 41
Shoe Spacers ............................................................................................. 42
Phillips Screwdriver .................................................................................... 42
L300 Plus Accessories ..................................................................................... 43
L300 Plus System Charger Set .................................................................. 43
Thigh FS Cuff Distal Panel Subassembly, Large ........................................ 44
Thigh FS Cuff Elongation Bar Lock Set ...................................................... 45
Thigh FS Cuff Electrode Marking Ring Set ................................................. 46
Thigh FS Cuff Cloth Electrodes .................................................................. 47
Chapter 6: Putting On and Taking Off the FS Cuffs .......................... 49
V
Preparing the Skin ............................................................................................ 49
Checking and Wetting the Electrodes .............................................................. 49
Positioning the L300 FS Cuff ............................................................................ 50
Removing the L300 FS Cuff ............................................................................. 54
Positioning the Thigh FS Cuff on the Quadriceps ............................................ 55
Positioning the Thigh FS Cuff on the Hamstrings ............................................. 60
Removing the Thigh FS Cuff ............................................................................ 65
Chapter 7: Placing the Gait Sensor in the Shoe ................................ 67
Switching Shoes/Gait Sensors ......................................................................... 70
Chapter 8: Operating the L300 Plus Control Unit .............................. 71
RF Communication Safety Features ................................................................ 71
Turning On/Off the Control Unit ........................................................................ 73
Selecting an Operating Mode ........................................................................... 73
Selecting Gait Mode ................................................................................... 73
Selecting Training Mode ............................................................................. 73
Returning to Standby Mode ........................................................................ 73
Adjusting Stimulation Intensity .......................................................................... 74
Adjusting the L300 RF Stim Unit ................................................................ 74
Adjusting the Thigh RF Stim Unit ................................................................ 76
Testing Stimulation ........................................................................................... 78
Testing the L300 FS Cuff ............................................................................ 78
Testing the Thigh FS Cuff ........................................................................... 78
Turning on Audio Feedback During Stimulation ............................................... 79
Turning on Audio Feedback for the L300 FS Cuff ...................................... 79
Turning on Audio Feedback for the Thigh FS Cuff...................................... 79
Muting the Audio Alerts ..................................................................................... 80
Muting the Thigh RF Stim Unit Alerts ............................................................... 80
VI
NESS L300 Plus
User’s Guide
Chapter 9: Component Maintenance and Cleaning .......................... 81
Charging the Batteries ...................................................................................... 81
Replacing the Batteries .................................................................................... 86
Replacing the RF Stim Unit Batteries ......................................................... 86
Replacing the Gait Sensor Battery ............................................................. 86
Replacing the L300 Plus Control Unit Battery ............................................ 87
Replacing the L300 Hydrogel Electrodes ......................................................... 89
Replacing the L300 Cloth Electrodes ............................................................... 92
Replacing the L300 Electrode Bases ............................................................... 95
Replacing the Thigh FS Cuff Cloth Electrodes ................................................. 98
Removing the RF Stim Units ............................................................................ 101
Inserting the RF Stim Units ............................................................................... 101
Cleaning the System Components ................................................................... 102
Chapter 10: Electronically Registering New Components ............... 103
Registering a New L300 Plus Control Unit ....................................................... 103
Registering a New RF Stim Unit ....................................................................... 106
Registering a New Gait Sensor ........................................................................ 108
Chapter 11: Troubleshooting ............................................................... 111
Chapter 12: Component Technical Specifications ............................ 117
VII
List of Symbols
Caution
Double Insulated (Equivalent to Class II of IEC 536)
Type BF Applied Part(s)
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This Product Must not be Disposed of with Other Household Waste
Consult Instructions for Use
Re-Order Number
Lot Number
1
Chapter 1 - Introduction
1
Introduction
Central nervous system injuries often cause a gait disorder called foot drop
and related muscle weakness in the thigh. People who have foot drop are
unable to raise their foot while walking. They often drag their foot, resulting in
instability and increased effort during gait. In addition, they may experience
difficulty flexing or extending their knee.
The NESS L300 Plus System is intended to provide ankle dorsiflexion and
knee flexion or extension in people suffering from foot drop and thigh muscle
weakness following an upper motor neuron injury or disease. The NESS L300
Plus System incorporates cutting-edge technology and sophisticated design
features to improve gait and quality of life.
The NESS L300 Plus System consists of four main components:
•The NESS L300 Functional Stimulation (FS) Cuff with Radio Frequency
(RF) Stimulation Unit for the lower leg
•A Thigh FS Cuff with RF Stim Unit for the quadriceps or hamstrings
•A Gait Sensor
•An L300 Plus Control Unit
These components communicate wirelessly to send electrical pulses to the
nerves that control the muscles of the lower leg and thigh. When stimulated
at the appropriate phase of walking, the muscles raise the foot and extend
or flex the knee, and may improve gait.
2
NESS L300 Plus
User’s Guide
Features of the NESS L300 Plus System include the following:
•Each FS Cuff includes a cradle for the RF Stim Unit.
•The FS Cuffs have an advanced ergonomic locator to ensure constant,
snug contact with the leg.
•The FS Cuffs can be put on with one hand and will easily fit under a
loose pant leg.
•The Gait Sensor detects when the foot is in the air and on the ground,
and wirelessly regulates stimulation in both FS Cuffs accordingly.
•
The wireless handheld Control Unit monitors system status and manages
system performance.
This User’s Guide describes the NESS L300 Plus System and how to operate
the system to achieve maximum benefits. It also describes important safety
information, and maintenance and cleaning instructions.
Be sure to review each section of this guide with your clinician before using
your NESS L300 Plus System. If you have any questions, consult your clinician
or Bioness Inc immediately.
3
Chapter 2 - For Your Health and Safety
For Your Health and Safety
Indications for Use
The NESS L300 Plus System is intended to provide ankle dorsiflexion and
knee flexion or extension in individuals who have foot drop and thigh muscle
weakness following an upper motor neuron injury or disease (such as a
stroke, traumatic brain injury, multiple sclerosis, cerebral palsy, or incomplete
spinal cord injuries).
During gait, the NESS L300 Plus System electrically stimulates muscles
in the affected leg to provide dorsiflexion of the foot and knee flexion or
extension; thus, it may improve the individual’s gait. The NESS L300 Plus
System may also:
•Facilitate muscle re-education.
•Prevent or retard disuse atrophy.
•Maintain or increase joint range of motion.
•Increase local blood flow.
Contraindications
•Patients with a demand-type cardiac pacemaker, defibrillator, or any
electrical or metallic implant should not use the NESS L300 Plus System.
•The NESS L300 Plus System should not be used where a cancerous
lesion is present or suspected.
2
4
NESS L300 Plus
User’s Guide
•
The NESS L300 Plus System should not be used on a leg where a regional
disorder, such as a fracture or dislocation, could be adversely affected
by motion from the stimulation.
Warnings
•The long-term effects of chronic electrical stimulation are unknown.
•
The NESS L300 Plus FS Cuffs should not be worn over swollen, infected,
or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis,
and varicose veins.
•
Simultaneous connection of the NESS L300 Plus to the patient and high-
frequency surgical equipment may result in skin burns where the stimulator
electrodes adhere and damage to the RF Stim Units.
•
Do not use the NESS L300 Plus within three feet of shortwave or microwave
therapy equipment. Such equipment may produce instability in the output
of the RF Stim Units.
•
The NESS L300 Plus should only be configured by an authorized clinician.
Precautions
•Inflammation in the region of the NESS L300 Plus FS Cuffs may be
aggravated by motion, muscle activity, or pressure from the FS Cuffs.
Stop using the NESS L300 Plus until the inflammation is gone.
•Use caution if you have a suspected or diagnosed heart problem.
•Use the FS Cuffs with caution:
•If you have a tendency to hemorrhage following acute trauma or
fracture.
•Following recent surgical procedures when muscle contraction
may disrupt the healing process.
5
Chapter 2 - For Your Health and Safety
•Over areas of the skin that lack normal sensation.
•If you have suspected or diagnosed epilepsy.
•Some patients may experience a skin irritation, an allergic reaction, or
hypersensitivity to the electrical stimulation or the electrical conductive
medium. Irritation may be avoided by having your clinician change the
stimulation parameters, type of electrodes, or electrode placement.
•Do not use the NESS L300 Plus without electrodes.
•
After removing the FS Cuffs, it is normal for the areas under the electrodes
to be red and indented. The redness should disappear in approximately
one hour. Persistent redness, lesions, or blisters are signs of irritation.
Stop using the NESS L300 Plus until any irritation is gone.
•Stop using the NESS L300 Plus and consult your clinician if stimulation
does not start at the correct time during gait.
•Do not wear the NESS L300 Plus during x-ray examinations.
•Turn off the NESS L300 Plus when at a refueling place. Do not use the
NESS L300 Plus near flammable fuel, fumes, or chemicals.
•Only your treating clinician should determine electrode placement and
stimulation settings.
•Use only NESS L300 Plus electrodes supplied by Bioness Inc.
•
Obtain physician clearance prior to use if you have an alteration in normal
arterial or venous flow in the region of the FS Cuffs because of local
insufficiency, occlusion, arteriovenous fistula for hemodialysis, or a primary
disorder of the vasculature.
•Obtain physician clearance before stimulating an area with a structural
deformity.
•The safe use of the NESS L300 Plus during pregnancy has not been
established.
6
NESS L300 Plus
User’s Guide
•Skin problems where the FS Cuffs are worn may be aggravated by the
NESS L300 Plus.
•
Turn off the NESS L300 Plus before removing or replacing the electrodes.
•Keep the NESS L300 Plus out of the reach of children.
•The NESS L300 Plus Control Unit is splash proof. However, protect
all electronic components from contact with water, such as from sinks,
bathtubs, shower stalls, rain, snow, etc.
•
Do not leave the NESS L300 Plus stored where temperatures may exceed
the acceptable environmental range: -20°C to +60°C (-4°F to +140°F).
Temperature extremes can damage the components.
•Do not attempt to repair your NESS L300 Plus. Contact Bioness if you
experience a technical problem not covered in this guide.
•The FS Cuffs are to be worn only on the leg of the patient for whom they
are fitted. They should not be worn by anyone else or on any other part
of the body.
•Turn off the NESS L300 Plus before putting on the FS Cuffs. Do not turn
on the NESS L300 Plus until the FS Cuffs are fastened in place.
•Shut off the NESS L300 Plus before driving, operating machinery, or
performing any activity in which involuntary muscle contractions could
injure you.
•Protect the NESS L300 Plus electronic components from condensation.
When moving the components between hot and cold temperatures, place
them in an airtight plastic bag, and let them slowly (for at least two hours)
adjust to the temperature change before use.
•
Medical electrical equipment needs special precautions for electromagnetic
compatibility.
7
Chapter 2 - For Your Health and Safety
Adverse Reactions
In the unlikely event that any of the following occurs, stop using your NESS
L300 Plus immediately and consult your physician.
•
Signs of significant irritation or pressure sores where the FS Cuffs contact
the skin.
•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.
Skin irritations and burns have been reported with the use of powered muscle
stimulators.
If you have any questions or concerns, please telephone the NESS
L300 Plus Technical and Clinical Support Department at (800) 211-9136,
Option 3.
8
NESS L300 Plus
User’s Guide
Skin Care Guidelines
In the absence of proper skin care, extended use of electrical stimulation may
cause skin irritation or a skin reaction to the electrodes or the FS Cuffs. Skin
irritation tends to occur after approximately three months of use. To promote
healthy skin with long-term use of the NESS L300 Plus, it is important to
follow a daily skin-care routine.
•Clean the skin where the electrodes adhere with a wet washcloth. If any
oils or lotions are on the skin, then clean with soap and water. Rinse well.
•Always check the skin for redness or a rash when putting on and taking
off the FS Cuffs.
•Replace the electrodes at least every two weeks, even if they appear to
be in good condition.
•After taking off the L300 FS Cuff, always re-cover hydrogel electrodes
with the protective plastic covers.
•Excess body hair where the electrodes adhere may reduce electrode
contact with the skin. If necessary, remove excess body hair with an
electric shaver or scissors. Do not use a razor. A razor can irritate the skin.
•
When positioning the FS Cuffs, make sure the electrodes uniformly contact
the skin.
•Ventilate the skin by removing the FS Cuffs for at least 15 minutes every
three to four hours.
If skin irritation or a skin reaction occurs, stop using your NESS L300 Plus
System immediately. Contact your clinician, dermatologist, or Bioness Clinical
Specialist. Resume use only when the skin is completely healed. Then follow
a skin conditioning protocol per the recommendation of your health-care
specialist.
9
Chapter 2 - For Your Health and Safety
If you have any questions or concerns, please telephone the NESS
L300 Plus Technical and Clinical Support Department at (800) 211-9136,
Option 3.
Caution: Do not put on or operate the NESS L300 Plus System
before being properly fitted and trained by a certified clinician.
Caution: The Gait Sensor has not been validated for use by
individuals weighing more than 300 pounds (136 kilograms).
Caution: Do not use the Gait Sensor with a rigid insole, such
as a custom rigid orthosis or an ankle foot orthosis.
Caution: Use only NESS L300 Plus electrodes supplied by
Bioness Inc. Do not use the NESS L300 Plus System without
electrodes.
Caution: Change the electrodes every two weeks.
Caution: Changes or modifications to the NESS L300 Plus
System components not expressly approved by Bioness Inc
could void the user's authority to operate the equipment.
10
NESS L300 Plus
User’s Guide
11
Chapter 3 - Environmental Conditions that Affect Use
3
Environmental Conditions that Affect Use
Radio Frequency (RF) Communication
Several components of the NESS L300 Plus System 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 (RF Devices) of the FCC
(Federal Communications Commission) Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses, and can radiate RF 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 assistance.
The antenna for each transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
Portable and mobile RF communications equipment can affect medical
electrical equipment.
12
NESS L300 Plus
User’s Guide
Conformity Certification
The L300 Plus complies with Part 15 of the FCC rules. Operation is subject
to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference
that may cause undesired operation.
Travel
The NESS L300 Plus System charger set is compatible with both European
and U.S. voltage: 110/220 V, 50/60 Hz. A voltage converter is not needed.
A simple outlet adaptor should work. Outlet adaptors can be purchased at
small electronic equipment stores.
Turn off your NESS L300 Plus System before going through airport security.
Wear loose clothing so that you can easily show the security person your
NESS L300 Plus. The NESS L300 Plus System will likely set off the security
alarm. Either ask for a “hand scan” or be prepared to remove your NESS
L300 Plus so that security can scan it. You may want to carry a copy of your
NESS L300 Plus prescription. A prescription can be useful when passing
through customs as well.
To request a copy of your prescription, call Bioness Customer Support:
Telephone: (800) 211-9136, Option 2; or (661) 362-4850, Option 2. A Bioness
representative can fax or mail you a copy.
Note: The NESS L300 Plus System contains radio transmitters. The Federal
Aviation Administration (FAA) rules require that all radio-transmitting devices
be turned off during flight.
13
Chapter 4 - Your NESS L300 Plus System Kit
Your NESS L300 Plus System Kit
Your NESS L300 Plus System includes components and accessories of
the NESS L300 Foot Drop System plus a Thigh FS Cuff, Thigh RF Stim
Unit, accessories for the Thigh FS Cuff, and a Control Unit. For individuals
who already have a NESS L300 Foot Drop System, an L300 Plus System
upgrade kit is provided.
Contents
System Components
•L300 FS Cuff with Strap, Right or Left
•L300 RF Stim Unit
•Thigh FS Cuff with Straps, Right or Left
•Thigh RF Stim Unit
•Gait Sensor
•L300 Plus Control Unit
4
L300 Plus Control Unit
L300 FS Cuff
with Strap and
RF Stim Unit
Thigh FS Cuff
with Straps and
RF Stim Unit Gait Sensor
14
NESS L300 Plus
User’s Guide
L300 Accessories
•L300 Hydrogel Electrodes
•L300 Hydrogel Electrode Bases
•L300 Cloth Electrodes
•L300 Cloth Electrode Bases
•Control Unit Neck Strap
•Control Unit Wrist Strap
•Control Unit Belt Pouch
•Replacement Battery, Gait Sensor
•Gait Sensor Pads
•Shoe Spacers
•Phillips Screwdriver
Hydrogel Electrode
Gait
Sensor
Battery
15
Chapter 4 - Your NESS L300 Plus System Kit
Cloth Electrode
Hydrogel
Electrode Base
Cloth
Electrode Base
Wrist Strap Belt Pouch
Neck Strap
Shoe Spacers
Gait Sensor Pads Phillips Screwdriver
16
NESS L300 Plus
User’s Guide
L300 Plus Accessories
•L300 Plus System Charger Set
•Thigh FS Cuff Distal Panel Subassembly, Large
•Thigh FS Cuff Elongation Bar Lock Set
•Thigh FS Cuff Electrode Marking Ring Set
•Thigh FS Cuff Cloth Electrodes
•L300 Plus System Kit Carrying Case with Strap
•NESS L300 Plus User’s Guide
•NESS L300 Plus User's Instruction Card
System Charger Set
Thigh FS Cuff Distal Panel Subassembly
Thigh FS Cuff Cloth Electrodes
Thigh FS Cuff Elongation
Bar Lock Set
Thigh FS Cuff Electrode
Marking Ring Set
17
Chapter 5 - System Components and Accessories
L300 Plus Upgrade Kit
For individuals who already have a NESS L300 Foot Drop System, an
L300 Plus System upgrade kit is provided.
Contents
•Thigh FS Cuff with Straps, Right or Left
•Thigh RF Stim Unit
•L300 Plus Control Unit
•L300 Plus System Charger Set
•Thigh FS Cuff Distal Panel Subassembly, Large
•Thigh FS Cuff Elongation Bar Lock Set
•Thigh FS Cuff Electrode Marking Ring Set
•Thigh FS Cuff Cloth Electrodes
•L300 Plus System Kit Carrying Case with Strap
•Replacement Battery, Gait Sensor
•Control Unit Neck Strap
•Control Unit Wrist Strap
•Control Unit Belt Pouch
•NESS L300 Plus User’s Guide
•NESS L300 Plus User's Instruction Card
18
NESS L300 Plus
User’s Guide
19
Chapter 5 - System Components and Accessories
5
System Components and Accessories
This section describes the components and accessories of the L300 Plus
System.
L300 Functional Stimulation (FS) Cuff
The L300 FS Cuff is an ergonomic orthosis that fits on the leg below the
knee. The L300 FS Cuff is designed to facilitate dorsiflexion of the foot. It
is lightweight, easy to put on with one hand, and can be worn under loose
clothing. An ergonomic locator on the L300 FS Cuff ensures accurate and
repeatable positioning of the surface electrodes on the lower leg. See Figure 1.
Figure 1: The L300 FS Cuff (right configuration) and L300 RF Stim Unit.
Liner
Electrode
Locator
Flexible
Strap
Handle
Cradle for
the RF
Stim Unit
Status Light
Stimulation Light
L300 RF
Stim Unit
Adjustable
Strap
20
NESS L300 Plus
User’s Guide
The L300 FS Cuff is available in right and left configurations. It is designed
to house an integrated L300 RF Stim Unit and two surface electrodes. The
RF Stim Unit produces the stimulation signal. The surface electrodes deliver
the stimulation signal from the RF Stim Unit to the leg. Both hydrogel and
cloth surface electrodes and electrode bases are provided.
Locator
The L300 FS Cuff features an ergonomic locator for accurate and repeatable
positioning of the surface electrodes. The locator forms a "V" and is placed
just under the kneecap.
RF Stim Unit Cradle
The L300 FS Cuff includes a cradle for the L300 RF Stim Unit. The RF Stim
Unit snaps in and out of the cradle, and is removed for maintenance and
cleaning.
Strap
The strap on the L300 Plus FS Cuff is adjustable and features a flexible strap
handle. Three strap sizes are available: small, medium, and large. The strap
can be removed and is replaceable.
Electrode Bases and Surface Electrodes
The L300 FS Cuff uses two surface electrodes to stimulate the skin. The
surface electrodes attach to two electrode bases, which connect to the FS
Cuff liner. During your fitting session, your clinician will determine the best
position for the electrode bases and electrodes on the L300 FS Cuff.
21
Chapter 5 - System Components and Accessories
L300 RF Stim Unit
The L300 RF Stim Unit generates the electrical stimulation pulses used to
dorsiflex the foot.
The L300 RF Stim Unit responds to wireless signals from the L300 Plus
Control Unit and the Gait Sensor to turn stimulation on/off. Features include
a rechargeable battery, a status light, and a stimulation light. See Table 1.
Display Description Definition
Status Light
Flashes GREEN System is On
Flashes YELLOW Low Battery
Alternately Flashes
YELLOW and
GREEN
Battery Charging
Solid GREEN Battery Fully Charged
Flashes RED Radio Communication
Failure
Solid RED RF Stim Unit
Malfunction
Stimulation
Light Flashes YELLOW
SLOWLY Stimulation is Off
Flashes YELLOW
RAPIDLY Stimulation is On
Table 1: L300 RF Stim Unit displays and definitions.
22
NESS L300 Plus
User’s Guide
RF Stim Unit
Cradle
L300 FS Cuff
L300 RF Stim
Unit
Figure 2: Removing the L300 RF Stim Unit.
The L300 RF Stim Unit emits both visual and audio alerts when radio
communication fails or the component malfunctions.
The L300 RF Stim Unit snaps in and out of the cradle of the L300 FS Cuff.
See Figure 2. The L300 RF Stim Unit should only be removed from the cradle
for maintenance and when cleaning the L300 FS Cuff.
23
Chapter 5 - System Components and Accessories
Thigh FS Cuff
The Thigh FS Cuff is an ergonomic orthosis that fits over the hamstrings or
quadriceps muscles. The Thigh FS Cuff is designed to be used in unison
with the L300 FS Cuff, to assist with knee flexion or extension throughout
the gait cycle. See Figure 3.
The Thigh FS Cuff is available in right and left configurations, and houses an
integrated Thigh RF Stim Unit and two surface electrodes. The Thigh RF Stim
Unit produces the stimulation signal. The electrodes deliver the stimulation
signal from the Thigh RF Stim Unit to the hamstrings or quadriceps muscles.
Figure 3: The Thigh FS Cuff.
RF Stim Unit
Cradle
Thigh FS
Cuff
Thigh RF Stim
Unit
Caution: The FS Cuffs should be removed from the skin every
three to four hours for 15 minutes to allow the skin to breathe.
24
NESS L300 Plus
User’s Guide
Distal and Proximal Panels
The Thigh FS Cuff features two panels: a distal panel that is positioned closer
to the knee and a proximal panel that is positioned farther from the knee.
The distal panel features a cradle for the Thigh RF Stim Unit. The L300 Plus
System Kit includes a replacement large distal panel that fits a larger leg
circumference, if needed.
Elongation Bar
Connecting the distal and proximal panels is an elongation bar. The elongation
bar is used to adjust the distance between the distal and proximal panels.
(Your clinician will determine the distance most appropriate for you and adjust
the elongation bar accordingly.) The elongation bar features a locator arrow
used to position the Thigh FS Cuff on the leg.
Straps
The distal and proximal panels each feature two straps used to secure the
Thigh FS Cuff on the leg. The straps are adjustable and can be fastened with
one hand. The straps are also washable and replaceable.
Surface Electrodes
The Thigh FS Cuff features two cloth electrodes. One electrode attaches
to the distal panel. One attaches to the proximal panel. During your fitting
session, your clinician will fit the electrodes to the Thigh FS Cuff. Afterward,
you will need to replace the electrodes every two weeks.
25
Chapter 5 - System Components and Accessories
RF Stim Unit
Cradle
Thigh FS
Cuff
Thigh RF Stim
Unit
Thigh RF Stim Unit
The Thigh RF Stim Unit snaps in and out of the cradle of the Thigh FS Cuff.
See Figure 4. The Thigh RF Stim Unit generates the electrical stimulation
pulses used to extend the quadriceps muscles or flex the hamstrings muscles.
The Thigh RF Stim Unit responds to wireless signals from the L300 Plus
Control Unit and the Gait Sensor to turn stimulation on/off. It has a rechargeable
battery, a status light, and a stimulation light. See Table 2.
Figure 4: Removing the Thigh RF Stim Unit.
26
NESS L300 Plus
User’s Guide
Display Description Definition
Status Light Flashes GREEN System is On
Flashes YELLOW Low Battery
Alternately Flashes
YELLOW and
GREEN
Battery Charging
Solid GREEN Battery Fully
Charged
Flashes RED Radio
Communication
Failure
Solid RED RF Stim Unit
Malfunction
Stim Light Flashes YELLOW
SLOWLY
Stimulation is Off
Flashes YELLOW
RAPIDLY
Stimulation is On
Table 2: Thigh RF Stim Unit displays and definitions.
The Thigh RF Stim Unit emits both visual and audio alerts when radio
communication fails or the component malfunctions.
The Thigh RF Stim Unit should be removed from the cradle for maintenance
and when cleaning the Thigh FS Cuff.
27
Chapter 5 - System Components and Accessories
Gait Sensor
The Gait Sensor consists of a pressure sensor and a transmitter. See Figure
5. The pressure sensor is used to detect when your foot is in the air and
on the ground. The transmitter is used to signal the L300 RF Stim Unit and
the Thigh RF Stim Unit to move your foot and knee accordingly. The Gait
Sensor communicates wirelessly with the L300 RF Stim Unit and the Thigh
RF Stim Unit.
Figure 5: NESS L300 Gait Sensor.
Clamp
Transmitter
Pressure
Sensor
28
NESS L300 Plus
User’s Guide
Figure 6: Gait Sensor placed in a left shoe.
The pressure sensor fits under the insole of the shoe of the affected leg,
attached to a Gait Sensor pad. See Figure 6. The transmitter is worn clamped
to the inner rim of the shoe. Shoe spacers are provided to protect the shoe
from damage from the clamp.
The Gait Sensor can be transferred to a different shoe, or additional sensors
can be purchased for different shoes. You do not need to detach the Gait
Sensor between uses.
The Gait Sensor is powered by a small non-rechargeable battery. The battery
will need to be replaced after approximately six months of use. The L300
Plus System Kit includes a replacement battery and a Phillips screwdriver
for changing the battery.
Caution: The Gait Sensor has not been validated for use by
individuals weighing more than 300 pounds (136 kilograms).
29
Chapter 5 - System Components and Accessories
L300 Plus Control Unit
The L300 Plus Control Unit is used to turn on/off the L300 Plus System, select
an operating mode (gait, training, standby, or clinician), fine-tune stimulation
intensity, mute audio alerts, test stimulation intensity of the individual RF
Stim Units, and monitor system performance. See Figure 7. The Control Unit
communicates wirelessly with the L300 RF Stim Unit, the Thigh RF Stim Unit,
and the Gait Sensor. It is powered by a single rechargeable AAA battery. It is
also small enough to be worn around the neck or wrist, or carried in a pocket
or belt pouch.
Figure 7: Control Unit operating buttons and digital display.
On/Off Button
Loop Hole for Wrist and Neck Straps
Mode Button
Intensity
Adjustment
(Plus/Minus)
Buttons
Digital
Display
Mute Button
RF Stim Unit
Selection
Buttons
Stimulation
Test Button
30
NESS L300 Plus
User’s Guide
Your L300 Plus System Kit includes a system charger set for charging the
Control Unit, the L300 RF Stim Unit, and the Thigh RF Stim Unit. It also
includes a belt pouch, wrist strap, and neck strap for carrying the Control
Unit. A Phillips screwdriver is provided for changing the Control Unit battery.
Control Unit Operating Buttons
The Control Unit operating buttons and their functions are described in Table 3.
Control Unit Operating Modes
The Control Unit has four operating modes: standby, gait, training, and clinician.
Only clinicians use clinician mode.
Standby Mode
In standby mode, the L300 Plus System is on and waiting for commands.
Stimulation is off.
Gait Mode
Gait mode is used when walking. In gait mode, the Gait Sensor signals the
L300 and Thigh RF Stim Units when your heel leaves the ground, turning
stimulation on. It also signals when your heel contacts the ground, turning
stimulation off.
Training Mode
Training mode is used to train muscles when you are not walking (for example,
sitting or lying down). Training mode should not be used when walking.
Training mode works independently of the Gait Sensor. Stimulation is delivered
in cycles pre-set by your clinician. Training mode is designed to facilitate
31
Chapter 5 - System Components and Accessories
Control Unit
Operating
Button Description Function
On/Off Turns On/Off the Control Unit
Mode Selects Standby, Gait,
Training, or Clinician Mode
Intensity
Adjustment
(Plus/Minus)
Adjusts Stimulation Intensity
Level
RF Stim Unit
Selection
"Up" Button Selects the Thigh
RF Stim Unit
"Down" Button Selects the
L300 RF Stim Unit
Mute
Mutes the Audio Indicators;
Selects Single Component
Mode
Stimulation
Test
Tests Stimulation for the
Selected RF Stim Unit
(Functional Only in Standby
Mode)
Table 3: Control Unit operating buttons and functions.
32
NESS L300 Plus
User’s Guide
Intelli-Sense
Gait Sensor
Indicator
L300 RF Stim Unit
Indicator
Control Unit Indicator
Thigh RF Stim
Unit Indicator
RF Communication
Error Indicator
Figure 8: Control Unit digital display and indicators.
muscle re-education, prevent or retard disuse atrophy of the lower leg and
thigh muscles, maintain or improve range of motion of the ankle and knee
joints, and improve local blood circulation.
Control Unit Digital Display and Indicator Lights
The Control Unit digital display and indicator lights indicate stimulation intensity
level, operating mode, battery charge status, electronic registration status,
and error messages. See Figure 8 and tables 4 and 5.
33
Chapter 5 - System Components and Accessories
Display Description Definition
On/Off Button Flashes
GREEN System is On
Mode Button Flashes
YELLOW SLOWLY
System is in Gait/Training/
Clinician Mode, Stimulation is Off
Mode Button Flashes
YELLOW RAPIDLY
System is in Gait/Training/
Clinician Mode, Stimulation is On
Displays 0–9 Intensity Level
Intensity Level and “t”
Alternate System is in Training Mode
A Component Indicator
Flashes YELLOW Component Low Battery
Top Arrow and Thigh RF Stim
Unit Indicator are GREEN Thigh RF Stim Unit Selected
Bottom Arrow and L300 RF Stim
Unit Indicator are GREEN L300 RF Stim Unit Selected
Rotating GREEN Circle Control Unit Charging
Horizontal GREEN Line Control Unit Fully Charged
Table 4: Control Unit visual displays and definitions.
34
NESS L300 Plus
User’s Guide
Display Description Definition
Thigh RF Stim Unit Indicator
Flashes RED Faulty Electrode Contact
Control Unit and RF Stim Unit
Indicators Alternately Flash
RED and “E” Flashes
Radio Communication Failure
Between the Control Unit and RF
Stim Unit
Gait Sensor and RF Stim Unit
Indicators Alternately Flash
RED
Gait Sensor Hibernation or Radio
Communication Failure between
the Gait Sensor and RF Stim Unit
A Component Indicator is Solid
RED Component Malfunction
Table 4: Control Unit error displays and definitions.
Control Unit Audio Indicators
The Control Unit beeps to indicate:
•The system is on.
•A button was pressed.
•Low battery.
•An error (usually accompanied by a visual indicator).

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