Bioness NESS L300 Plus User manual

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: [phone]
Email: [email protected]
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: [phone], Option 2; or [phone], 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

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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.

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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.
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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.

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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 [phone],
Option 3.

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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 [phone],
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.

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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.

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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: [phone], Option 2; or [phone], 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