Bioness NESS L300 User manual

Manufactured by Bioness Neuromodulation Ltd.
A Bioness Inc Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
European Authorized Representative
NESS Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
Worldwide Corporate Office
Bioness Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
NESS®, NESS L300®, Intelli-Gait®, Intelli-Sense Gait Sensor™, Bioness, the Bioness Logo® and LiveOn® are
registered trademarks of Bioness Inc. in the United States or other countries | www.bioness.com
Rx Only (U.S. Only)
612-00061-001 Rev D
01/2013

NESS L300®
User’s Guide

User’s Guide

II
User’s Guide Copyright
© 2006, Revised 2012, 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®, Intelli-Gait®, Intelli-Sense Gait Sensor™, Bioness, the Bioness Logo® and LiveOn® are
registered trademarks of Bioness Inc. in the United States or other countries | www.bioness.com
Patents Pending
Aspects of this device are covered by several patents and patent applications including US Pat 7,899,556.
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, 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.
Conformity Certification
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
European Authorized Representative
NESS Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com

III
Contents
List of Symbols .................................................................................................. v
Chapter 1: Introduction ........................................................................ 1
Chapter 2: Health and Safety Information ........................................... 3
Indications for Use ............................................................................................. 3
Contraindications ............................................................................................... 3
Warnings ........................................................................................................... 3
Precautions ........................................................................................................ 4
Adverse Reactions ............................................................................................ 6
Skin Care Guidelines ......................................................................................... 7
Chapter 3: Environmental Conditions that Affect Use ....................... 9
Radio Frequency (RF) Communication ............................................................. 9
Travel ................................................................................................................. 10
Chapter 4: NESS L300 System Kit ....................................................... 13
Chapter 5: NESS L300 System Components ...................................... 17
Functional Stimulation (FS) Cuff ....................................................................... 17
Electrodes and Electrode Bases ....................................................................... 18
RF Stim Unit ...................................................................................................... 20
Intelli-Sense Gait Sensor ................................................................................... 21
Control Unit ........................................................................................................ 22
Control Unit Operating Buttons .................................................................... 23
Control Unit Operating Modes ..................................................................... 24
Control Unit Digital Display and Indicator Lights ......................................... 24
Control Unit Audio Indicators ....................................................................... 26
Chapter 6: Setting Up the NESS L300 System .................................... 27
Positioning the FS Cuff ...................................................................................... 27
Removing the FS Cuff ....................................................................................... 30
Positioning the Intelli-Sense Gait Sensor .......................................................... 31

IV
Chapter 7: Operating the NESS L300 .................................................. 35
RF Communication Safety Features ................................................................. 35
Operating the Control Unit ................................................................................. 35
Turning On/Off the Control Unit ................................................................... 35
Selecting an Operating Mode ...................................................................... 36
Adjusting Stimulation Intensity ..................................................................... 37
Adjusting the Volume of Audio Alerts ........................................................... 37
Turning On Audio Feedback During Stimulation .......................................... 38
Chapter 8: Maintenance and Cleaning ................................................ 39
Charging the Batteries ....................................................................................... 39
Replacing the Batteries ..................................................................................... 43
RF Stim Unit Battery .................................................................................... 43
Intelli-Sense Gait Sensor Battery ................................................................ 43
Control Unit Battery ..................................................................................... 44
Replacing the L300 Quick Fit Electrodes .......................................................... 46
Replacing the Cloth Electrodes ......................................................................... 48
Replacing the Hydrogel Electrodes ................................................................... 50
Replacing the Electrode Bases ......................................................................... 52
Removing the RF Stim Unit ............................................................................... 54
Inserting the RF Stim Unit ................................................................................. 54
Cleaning Your NESS L300 Components ........................................................... 55
Chapter 9: Electronically Registering New Components .................. 57
Registering a New Control Unit ......................................................................... 57
Registering a New RF Stim Unit ........................................................................ 60
Registering a New Intelli-Sense Gait Sensor .................................................... 62
Chapter 10: Troubleshooting ................................................................ 65
Chapter 11: Technical Specifications .................................................. 71
Chapter 12: Appendix - EMI Tables ...................................................... 79

V
List of Symbols
Caution
Complies with United States and Canadian Product Safety
Standards
Complies with the European Union Medical Device Directive
Serial Number
Double Insulated (Equivalent to Class II of IEC 536)
Type BF Applied Part(s)
Non-Ionizing Radiation
European Authorized Representative
Date of Manufacture
Manufacturer
This Product Must not be Disposed of with Other Household Waste
Consult Instructions for Use
Re-Order Number
Lot Number
Certification of Radio Products for the Japanese Market

VI

1
Chapter 1 - Introduction
1
Introduction
Central nervous system injuries often cause a gait disorder called foot drop.
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.
The NESS L300 Foot Drop System is an advanced neuroprosthesis designed
to improve gait in people suffering from foot drop. The NESS L300 incorporates
cutting-edge technology and sophisticated design features to improve walking
and quality of life.
The NESS L300 consists of a Functional Stimulation (FS) Cuff (available in
regular and small sizes) with a Radio Frequency (RF) Stim Unit, an Intelli-
Sense Gait Sensor, and a Control Unit. These components communicate
wirelessly to send electrical pulses to the peroneal nerve, which controls
the muscles of the lower leg. When stimulated at the appropriate phase of
walking, the muscles raise the foot, thereby preventing foot drop.
Functional Stimulation Cuff with
Radio Frequency Stim Unit
Intelli-Sense
Gait Sensor Control Unit
Regular L300
FS Cuff Small L300 FS Cuff

2User’s Guide
System Features:
• The FS Cuff includes a cradle for the RF Stim Unit and an advanced
ergonomic locator to ensure constant, snug contact with the leg. The FS
Cuff can be put on with one hand.
• The Intelli-Sense Gait Sensor can detect when the foot is in the air and
on the ground and regulate stimulation appropriately.
•
The wireless hand-held Control Unit monitors system status and manages
system performance.
Your clinician has prescribed the NESS L300 Foot Drop System to treat your
foot drop. This User’s Guide describes your NESS L300 Foot Drop System
and how to operate your system to achieve maximum benefits. Be sure to
read this guide before using your NESS L300. If you have any questions,
consult your clinician or your local distributor immediately.

3
Chapter 2 - Health and Safety Information
Health and Safety Information
Indications for Use
The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion
in individuals (adults and pediatrics) who have 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. The NESS L300 may improve gait, facilitate muscle re-education,
prevent or retard disuse atrophy, maintain or increase joint range of motion,
and 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.
•
The NESS L300 should not be used where a cancerous lesion is present
or suspected.
• The NESS L300 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.
• The NESS L300 should not be used on a leg where strength testing or
strength training is planned.
Warnings
• The long-term effects of chronic electrical stimulation are unknown.
•
The FS Cuff should not be worn over swollen, infected, or inflamed areas
or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins.
2

4User’s Guide
• Simultaneous connection of the NESS L300 to the patient and high-
frequency surgical equipment may result in skin burns where the stimulator
electrodes adhere and damage to the RF Stim Unit.
• Do not use the NESS L300 within three feet of short wave or microwave
therapy equipment. Such equipment may produce instability in the RF
Stim Unit output.
• The NESS L300 should only be configured by an authorized clinician.
Precautions
• Inflammation in the region of the NESS L300 FS Cuff may be aggravated
by motion, muscle activity, or pressure from the FS Cuff. Stop using the
NESS L300 until the inflammation is gone.
• Use caution if you have a suspected or diagnosed heart problem.
• Use the FS Cuff 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.
• 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 without electrodes.
• After removing the FS Cuff, it is normal for the areas under the electrodes
to be red and indented. The redness should disappear in approximately

5
Chapter 2 - Health and Safety Information
one hour. Persistent redness, lesions, or blisters are signs of irritation. Alert
your clinician and stop using the NESS L300 until any inflammation is gone.
• Stop using the NESS L300 and consult your clinician if stimulation does
not start at the correct time during gait.
• Do not wear the NESS L300 during x-ray examinations.
• Turn off the NESS L300 when at a refueling place. Do not use the NESS
L300 near flammable fuel, fumes, or chemicals.
• Only your treating clinician should determine electrode placement and
stimulation settings.
• Use only NESS L300 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 Cuff 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 during pregnancy has not been established.
• Skin problems where the FS Cuff is worn may be aggravated by the
NESS L300.
• Turn off the NESS L300 before removing or replacing the electrodes.
•
Adult supervision and assistance should be provided for anyone needing
help while using the NESS L300 system.
• Protect all electronic components from contact with water, such as from
sinks, bathtubs, shower stalls, rain, snow, etc.
• Do not leave the NESS L300 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.

6User’s Guide
• Do not attempt to repair your NESS L300. Contact Bioness if you experience
a technical problem not covered in this guide.
•
The FS Cuff is to be worn only on the leg of the patient for whom it is fitted.
It should not be worn by anyone else or on any other part of the body.
• Turn off the NESS L300 before putting on the FS Cuff. Do not turn on the
NESS L300 until the FS Cuff is fastened in place.
•
Shut off the NESS L300 before driving, operating machinery, or performing
any activity in which involuntary muscle contractions could injure you.
•
Protect the NESS L300 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.
Adverse Reactions
In the unlikely event that any of the following occurs, stop using your NESS
L300 immediately and consult your physician.
•
Signs of significant irritation or pressure sores where the FS Cuff contacts
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.

7
Chapter 2 - Health and Safety Information
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 Cuff. Skin
irritation tends to occur after approximately three months of use. To promote
healthy skin with long-term use of the NESS L300, 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 Cuff.
• Replace the electrodes at least every two weeks, even if they appear to
be in good condition.
•
After taking off the FS Cuff, always re-cover hydrogel electrodes with the
protective plastic covers, where applicable.
• 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 Cuff, make sure the electrodes uniformly contact
the skin.
• Ventilate the skin by removing the FS Cuff for at least 15 minutes every
three to four hours.
If skin irritation or a skin reaction occurs, stop using your NESS L300 immediately.
Contact your clinician, dermatologist, or Bioness Clinical Specialist. Resume
use only when the skin is completely healed, and then follow a skin conditioning
protocol per the recommendation of your health-care specialist.

8User’s Guide
Caution: Do not put on or operate the NESS L300 before being
properly fitted and trained by a certified clinician.
Caution: The Intelli-Sense Gait Sensor has not been validated
for use by individuals weighing more than 136 kilograms (300
pounds).
Caution: Do not use the Intelli-Sense Gait Sensor with a rigid
insole, such as a custom rigid orthosis or an ankle foot orthosis.
Caution: Use only NESS L300 electrodes supplied by Bioness
Inc. Do not use the NESS L300 without electrodes.
Caution: Change the electrodes every two weeks.
Caution: Changes or modifications to the NESS L300 not
expressly approved by Bioness Inc could void the user's
authority to operate the equipment.
If you have any questions or concerns, please contact your local distributor.
Caution: Use only the charger included in your NESS L300
System Kit. Use of any other charger could damage the system.
Caution: The control unit neck strap is meant to be worn around
the neck and if not used properly could cause bodily harm.

9
Chapter 3 - Environmental Conditions that Affect Use
3
Environmental Conditions that Affect Use
Radio Frequency (RF) Communication
Several components 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 (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 the NESS
L300 System.

10 User’s Guide
Conformity Certification
The NESS L300 System 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 System charger set with interchangeable blades is compatible
with both European and U.S. voltage: 110/220 V, 50/60 Hz.
Turn off your L300 system before going through airport security. Wear loose
clothing so that you can easily show the security person your NESS L300.
The NESS L300 will likely set off the security alarm. Either ask for a “hand
scan” or be prepared to remove your NESS L300 so that security can scan it.
You may want to carry a copy of your NESS L300 prescription. A prescription
can be useful when passing through customs as well.
Note: The NESS L300 contains radio transmitters. The Federal Aviation
Administration (FAA) rules require that all radio-transmitting devices be turned
off during flight.

11
Chapter 3 - Environmental Conditions that Affect Use
Electromagnetic Emissions
The NESS L300 System needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according
to the EMC information provided in this manual.
The NESS L300 System was tested and certified to use the following:
• DC power supply as provided by Bioness Inc, manufactured by Friwo,
Part No. FW7555M/05.
• "Y" cable (2-way splitter) as provided by Bioness Inc. Manufactured by
Tamuz Electronics Ltd.
Warnings
• The use of accessories, transducers, and cables other than those specified,
with the exception of transducers and cables sold by the manufacturer of
the NESS L300 System as replacement parts for internal components,
may result in increased emissions or decreased immunity of the NESS
L300 System.
• The NESS L300 System should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the configuration
in which it will be used.
•
The use of the accessory, transducer, or cable with equipment and systems
other than those specified may result in increased emissions or decreased
immunity of the NESS L300 System.

12 User’s Guide
• The NESS L300 System may be interfered with by other equipment, even if
that other equipment complies with CISPR (International Special Committee
on Radio Interference, International Electrotechnical Commission (IEC))
emission requirements.