Bioness Neuromodulation A Bioness L3P-N-CU-V20 L300 Plus Control Unit User Manual User manual 21179
Bioness Neuromodulation ltd. A Bioness Inc Company L300 Plus Control Unit User manual 21179
Contents
manual part 1
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
602-00382-001 Rev. B
Manufactured by Bioness Neuromodulation Ltd.
A Bioness Inc Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
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
Rx Only
User’s Guide
I
User’s Guide
Rx Only
II User's Guide
User’s Guide Copyright
© 2011, 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 symbol ® 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, 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 Plus System,
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 Client Relations Department: Telephone: (800) 211-9136, Option 2; or (661) 362-4850, Option 2.
III
Contents
List of Symbols ................................................................................................. VII
Chapter 1: Introduction ........................................................................ 1
Chapter 2: Device Description and Safety Information .................... 3
Device Description ............................................................................................ 3
Indications for Use ............................................................................................ 4
Contraindications .............................................................................................. 4
Warnings .......................................................................................................... 5
Precautions ....................................................................................................... 5
Adverse Reactions ........................................................................................... 9
Skin Care Guidelines ........................................................................................ 9
Chapter 3: Environmental Conditions that Affect Use ...................... 11
Radio Frequency (RF) Communication Information ......................................... 11
Travel and Airport Security ............................................................................... 12
Electromagnetic Emissions .............................................................................. 13
Warnings ..................................................................................................... 13
Chapter 4: NESS L300 Plus System Kits ............................................ 15
NESS L300 Plus System Kit ............................................................................. 15
System Components .................................................................................. 15
Accessories ................................................................................................ 15
NESS L300 Plus System Upgrade Kit .............................................................. 18
System Components .................................................................................. 18
Accessories ................................................................................................ 18
Chapter 5: NESS L300 Plus System ................................................... 19
L300 Functional Stimulation (FS) Cuff ............................................................. 19
Locator ........................................................................................................ 20
Cradle ......................................................................................................... 20
IV User's Guide
Strap ........................................................................................................... 20
L300 Electrodes and Electrode Bases ....................................................... 20
L300 RF Stim Unit ...................................................................................... 21
Thigh FS Cuff .................................................................................................. 23
Panels ......................................................................................................... 24
Elongation Bar ............................................................................................ 24
Locator ........................................................................................................ 24
Cradle ......................................................................................................... 24
Thigh Cloth Electrodes ............................................................................... 25
Thigh RF Stim Unit ..................................................................................... 26
Intelli-Sense Gait Sensor .................................................................................. 28
L300 Plus Control Unit ...................................................................................... 30
Operating Modes ........................................................................................ 32
Standby Mode ....................................................................................... 32
Gait Mode ............................................................................................. 32
Training Mode ....................................................................................... 32
Digital Display and Indicator Lights ............................................................ 33
Audio Indicators .......................................................................................... 38
Chapter 6: L300 Plus Accessories ...................................................... 39
L300 Electrodes and Bases .............................................................................. 39
Large Cloth Electrode ................................................................................. 40
L300 Hydrogel Electrodes and Bases ........................................................ 43
L300 Cloth Electrodes and Bases .............................................................. 47
Thigh Cloth Electrodes ..................................................................................... 51
Thigh Electrode Marking Ring .......................................................................... 55
Cloth Electrode Mesh Bag ................................................................................ 56
Thigh Elongation Bar Lock ............................................................................... 57
V
Control Unit Wrist Strap, Neck Strap, and Belt Pouch ...................................... 58
System Charger Set ......................................................................................... 59
Replacement Battery, Gait Sensor ................................................................... 60
Gait Sensor Pads ............................................................................................. 61
Shoe Spacers ................................................................................................... 62
Chapter 7: Setting Up the NESS L300 Plus System .......................... 63
Preparing the Skin ............................................................................................ 63
Checking the Components ............................................................................... 63
Putting on the L300 FS Cuff ............................................................................. 64
Testing the Position of the L300 FS Cuff .................................................... 68
Putting on the Thigh FS Cuff ............................................................................ 69
Testing the Position of the Thigh FS Cuff ................................................... 71
Placing the Intelli-Sense Gait Sensor in the Shoe ............................................ 72
Transferring the Intelli-Sense Gait Sensor to Another Shoe ....................... 76
Using Multiple Intelli-Sense Gait Sensors .................................................. 76
Chapter 8: Operating the NESS L300 Plus System ........................... 77
Turning On/Off the NESS L300 Plus System ................................................... 77
Testing the Position of the FS Cuffs ................................................................. 78
L300 FS Cuff............................................................................................... 78
Thigh FS Cuff.............................................................................................. 78
Selecting an Operating Mode ........................................................................... 79
Selecting Gait Mode ................................................................................... 79
Selecting Training Mode ............................................................................. 79
Returning to Standby Mode ........................................................................ 80
Adjusting Stimulation Intensity .......................................................................... 81
L300 FS Cuff............................................................................................... 81
VI User's Guide
Adjustment Guidelines ................................................................................ 82
Thigh FS Cuff.............................................................................................. 83
Turning on Audio Feedback During Stimulation ............................................... 84
L300 FS Cuff............................................................................................... 84
Thigh FS Cuff.............................................................................................. 85
Muting/Un-Muting the L300 Plus Control Unit .................................................. 86
Turning Off Audio/Visual Alerts ......................................................................... 87
L300 FS Cuff............................................................................................... 87
Thigh FS Cuff.............................................................................................. 87
Chapter 9: Maintenance and Cleaning ............................................... 89
Daily Maintenance ............................................................................................ 89
Charging the Batteries ...................................................................................... 90
Battery Replacement ........................................................................................ 95
Bases ................................................................................................................ 100
L300 FS Cuff Strap ........................................................................................... 103
Thigh Silicone Panels ....................................................................................... 104
Removing the L300 and Thigh RF Stim Units .................................................. 107
Cleaning the L300 Plus Components ............................................................... 108
Disinfecting the L300 Plus Components ........................................................... 109
Chapter 10: Electronic Registration ................................................... 111
Chapter 11: Troubleshooting ............................................................... 117
Chapter 12: Technical Specifications ................................................. 125
Chapter 13: Appendix - EMI Tables ..................................................... 135
VII
List of Symbols
Caution or Warning
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
Serial Number
Re-Order Number
Lot Number
Complies with United States and Canadian Product Safety Standards
Complies with the European Union Medical Device Directive
Single Patient Use
VIII User's Guide
1
Chapter 1 - Introduction
1
Introduction
Central nervous system (CNS) injuries and diseases 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. Many people with CNS injuries/diseases also suffer from thigh
muscle weakness. Weak thigh muscles can cause considerable difficulties
with flexing or extending the knee during ambulation.
The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee
flexion or extension in individuals with foot drop and thigh muscle weakness
following an upper motor neuron injury or disease.
This NESS L300 Plus User’s Guide describes:
xImportant safety information about the NESS L300 Plus System.
xThe components of the NESS L300 Plus System.
xHow to set up, operate, and maintain the NESS L300 Plus System.
xTroubleshooting information.
Be sure to review this guide with your clinician before using the NESS L300
Plus System.
If you have clinical or technical questions, consult your clinician or the Bioness
Client Relations Department at (800) 211-9136, Option 3, or visit the Bioness
website: www.bioness.com.
CAUTION: Do not put on or operate the NESS L300 Plus System
before being properly fitted and trained by a certified clinician.
2User's Guide
3
Chapter 2 - Device Description and Safety Information
2
Device Description and Safety
Information
Device Description
The NESS L300 Plus System consists of four main components:
xL300 Functional Stimulation (FS) Cuff with L300 Radio Frequency
(RF) Stim Unit—used to stimulate the nerves that control the muscles
of the lower leg.
xThigh FS Cuff with Thigh RF Stim Unit—used to stimulate the nerves
that control the muscles of the thigh.
xIntelli-Sense Gait Sensor—used to sense and wirelessly transmit heel
events in the affected leg.
xL300 Plus Control Unit—used to wirelessly control and monitor the
NESS L300 Plus System.
These components communicate wirelessly to provide synchronized ankle
dorsiflexion and knee flexion or extension.
4User's Guide
Indications for Use
The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee
flexion or extension in individuals with foot drop and thigh muscle weakness
following an upper motor neuron injury or disease.
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:
xFacilitate muscle re-education.
xPrevent or retard disuse atrophy.
xMaintain or increase joint range of motion.
xIncrease local blood flow.
Contraindications
xPatients with a demand-type cardiac pacemaker, defibrillator, or any
electrical or metallic implant should not use the NESS L300 Plus System.
xThe NESS L300 Plus System should not be used on a leg where a
cancerous lesion is present or suspected.
x
The NESS L300 Plus System should not be used on a leg with a regional
disorder, such as a fracture or dislocation, which could be adversely
affected by motion from the stimulation.
5
Chapter 2 - Device Description and Safety Information
Warnings
xThe long-term effects of chronic electrical stimulation are unknown.
xThe L300 and Thigh FS Cuffs should not be worn over swollen, infected,
or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis,
and varicose veins.
xSimultaneous connection of the NESS L300 Plus System to the patient
and high-frequency surgical equipment may result in skin burns where
the stimulator electrodes touch and damage to the L300 and Thigh RF
Stim Units.
x
The NESS L300 Plus System should only be configured by an authorized
clinician.
Precautions
x
Inflammation in the region of the L300 and Thigh FS Cuffs may be aggravated
by motion, muscle activity, or pressure from the FS Cuffs. Stop using the
NESS L300 Plus System until any inflammation is gone.
xUse caution if you have a suspected or diagnosed heart problem.
xUse caution if you have suspected or diagnosed epilepsy.
xUse the L300 and Thigh FS Cuffs with caution:
xIf you have a tendency to bleed heavily following acute trauma
or fracture.
xFollowing recent surgical procedures when muscle contraction
may disrupt the healing process.
xOver areas of the skin that lack normal sensation.
6User's Guide
x
Obtain physician clearance prior to use if you have an alteration in normal
arterial or venous flow in the region of the L300 and/or Thigh FS Cuffs
because of local insufficiency (insufficient blood flow), occlusion (a blood
flow blockage), arteriovenous fistula for the purpose of hemodialysis (an
abnormal connection between an artery and vein), or a primary disorder
of the vasculature (a disease of the blood vessels: arteries, veins, and
lymphatics).
xObtain physician clearance before stimulating an area with a structural
deformity.
xThe safe use of the NESS L300 Plus System during pregnancy has not
been established.
xKeep the NESS L300 Plus System out of the reach of children.
x
The L300 and Thigh FS Cuffs are to be worn only on the leg of the patient
for whom they have been fitted. They should not be worn by anyone else
or on any other part of the body.
xSkin problems where the L300 and Thigh FS Cuffs are worn may be
aggravated by the NESS L300 Plus System.
xSome patients may experience a skin irritation, an allergic reaction, or
hypersensitivity to the electrical stimulation or the electrical conductive
medium. In some cases, irritation may be avoided by having your clinician
change the stimulation parameters, type of electrodes used, or electrode
placement.
x
After removing the L300 and Thigh 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 System until any irritation
is gone.
7
Chapter 2 - Device Description and Safety Information
xDo not use the NESS L300 Plus System without electrodes.
xUse only electrodes supplied by Bioness Inc.
xChange the electrodes at least every two weeks.
xOnly the treating clinician should determine electrode placement and
stimulation settings.
xTurn off the NESS L300 Plus System before removing, replacing, and
wetting the electrodes.
xTurn off the NESS L300 Plus System before putting on the L300 and
Thigh FS Cuffs. Do not turn on the NESS L300 Plus System until the FS
Cuffs are fastened in place.
x
Turn off the NESS L300 Plus System before driving, operating machinery,
or performing any activity in which involuntary muscle contractions could
injure you.
x
Turn off the NESS L300 Plus System when at a refueling place. Do not use
the NESS L300 Plus System near flammable fuel, fumes, or chemicals.
xStop using the NESS L300 Plus System and consult your clinician if
stimulation does not start at the correct time during gait.
xProtect all electronic components from contact with water, such as from
sinks, bathtubs, shower stalls, rain, snow, etc.
xDo not leave the NESS L300 Plus System stored where temperatures
may exceed the acceptable environmental range: -25°C to +55°C (-13°F
to +131°F). Temperature extremes can damage the components.
xThe NESS L300 Plus 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.
See Chapter 3 and the Appendix.
8User's Guide
xDo not attempt to repair your NESS L300 Plus System. 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.
Contact the Bioness Client Relations Department, Option 3, if you
experience a clinical or technical problem not covered in this guide.
CAUTION: The Intelli-Sense Gait Sensor has not been validated
for use by individuals weighing more than 300 pounds (136
kilograms).
CAUTION: Do not use the Intelli-Sense Gait Sensor with a
rigid insole, such as a custom rigid orthosis or an ankle foot
orthosis.
9
Chapter 2 - Device Description and Safety Information
Adverse Reactions
In the unlikely event that any of the following occurs, stop using your
NESS L300 Plus System immediately and consult your physician:
xSigns of significant irritation or pressure sores where the L300 and/or
Thigh FS Cuffs contact the skin.
xA significant increase in muscle spasticity.
xA feeling of heart-related stress during stimulation.
xSwelling of the leg, knee, ankle, or foot.
xAny other unanticipated reaction.
Skin irritations and burns have been reported with the use of powered muscle
stimulators.
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 NESS L300 Plus System
electrodes or the L300 and/or Thigh FS Cuffs.
To promote healthy skin with long-term use of the NESS L300 Plus
System, it is important to follow a daily skin-care routine:
xClean the skin where the electrodes touch with a wet washcloth. If any
oils or lotions are on the skin, then clean with soap and water. Rinse well.
xAlways check the skin for redness or a rash when putting on and taking
off the L300 and Thigh FS Cuffs.
xWet the cloth electrodes before use and after every three to four hours
of use.
10 User's Guide
xReplace the electrodes at least every two weeks, even if they appear to
be in good condition.
xStore the L300 hydrogel electrodes with the protective plastic covers
attached. Do not allow the hydrogel electrodes to dry.
xStore the cloth electrodes where they can air dry.
x
Excess body hair where the L300 hydrogel 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.
x
When positioning the L300 and Thigh FS Cuffs, make sure the electrodes
uniformly contact the skin.
xVentilate the skin by removing the L300 and Thigh FS Cuffs for at least
15 minutes every 3 to 4 hours.
If skin irritation or a skin reaction occurs, stop using your NESS L300 Plus System
immediately. Contact your clinician or dermatologist, and the Bioness Client
Relations Department, Option 3. Resume use only when the skin is completely
healed. Then follow a skin conditioning protocol per the recommendation of
your health-care specialist.
If you have any questions or concerns, please call the Bioness Client
Relations Department at (800) 211-9136, Option 3.
11
Chapter 3 - Environmental Conditions that Affect Use
3
Environmental Conditions that Affect
Use
Radio Frequency (RF) Communication Information
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:
xReorient or relocate the receiving antenna.
xIncrease the separation between the equipment and receiver.
x
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 Plus System.
13
Chapter 3 - Environmental Conditions that Affect Use
Electromagnetic Emissions
The NESS L300 Plus System needs special precautions regarding
electromagnetic compatibility (EMC). The system needs to be installed and
put into service according to the EMC information provided in this manual.
See Appendix.
The NESS L300 Plus System was tested and certified to use the following:
xDC power supply as provided by Bioness Inc, manufactured by FRIWO,
Part No. FW7555M/05.
x
W cable (3-way splitter) as provided by Bioness Inc, Model No. L3P-5A00.
Manufactured by Tamuz Electronics Ltd.
Warnings
x
Do not use the NESS L300 Plus System within three feet of shortwave or
microwave therapy equipment. Such equipment may produce instability
in the output of the L300 and Thigh RF Stim Units.
xRemove the NESS L300 Plus System before undergoing any diagnostic
or therapeutic medical procedure such as x-ray examination, ultrasound,
Magnetic Resonance Imaging (MRI), etc.
x
The NESS L300 Plus 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.
x
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 Plus System as replacement parts for internal components,
may result in increased emissions or decreased immunity of the NESS
L300 Plus System.
14 User's Guide
x
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 Plus System.
x
The NESS L300 Plus 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)
emission requirements.