Bioness NESS L300 Plus User manual

NESS®, NESS L300®, NESS L300®Plus, Intelli-Gait®, Intelli-Sense Gait Sensor™, Bioness, the Bioness Logo®and LiveOn®
are trademarks of Bioness Inc in the United States or other countries. | www.bioness.com/Landing.php?reset
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: [phone]
Email: [email protected]
Website: www.bioness.com
Rx Only (US Only)
612-00313-001 Rev. B
European Authorized Representative
NESS Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com /Landing.php?reset
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User’s Guide
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I
User’s Guide
Rx Only (US Only)
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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 in the United States or other countries. | www.bioness.com/Landing.
php?reset | Rx Only (US Only).
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: [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 /Landing.php?reset
Conformity Certification
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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
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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
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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
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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
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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
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VIII User's Guide
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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:
•Important safety information about the NESS L300 Plus System.
•The components of the NESS L300 Plus System.
•How to set up, operate, and maintain the NESS L300 Plus System.
•Troubleshooting 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 your local
distributor, or visit the Bioness website: www.bioness.com /Landing.php?reset.
CAUTION: Do not put on or operate the NESS L300 Plus System
before being properly fitted and trained by a certified clinician.
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2User's Guide
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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:
•L300 Functional Stimulation (FS) Cuff with L300 Radio Frequency
(RF) Stim Unit—used to stimulate the nerves that control the muscles
of the lower leg.
•Thigh FS Cuff with Thigh RF Stim Unit—used to stimulate the nerves
that control the muscles of the thigh.
•Intelli-Sense Gait Sensor—used to sense and wirelessly transmit heel
events in the affected leg.
•L300 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.
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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:
•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 on a leg where a
cancerous lesion is present or suspected.
• 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.
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5
Chapter 2 - Device Description and Safety Information
Warnings
•The long-term effects of chronic electrical stimulation are unknown.
•The 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.
•Simultaneous 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.
•
The NESS L300 Plus System should only be configured by an authorized
clinician.
Precautions
• 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.
•Use caution if you have a suspected or diagnosed heart problem.
•Use caution if you have suspected or diagnosed epilepsy.
•Use the L300 and Thigh FS Cuffs with caution:
•If you have a tendency to bleed heavily 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.
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6User's Guide
• 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).
•Obtain physician clearance before stimulating an area with a structural
deformity.
•The safe use of the NESS L300 Plus System during pregnancy has not
been established.
•Keep the NESS L300 Plus System out of the reach of children.
•
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.
•Skin problems where the L300 and Thigh FS Cuffs are worn may be
aggravated by the NESS L300 Plus System.
•Some 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.
•
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.
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7
Chapter 2 - Device Description and Safety Information
•Do not use the NESS L300 Plus System without electrodes.
•Use only electrodes supplied by Bioness Inc.
•Change the electrodes at least every two weeks.
•Only the treating clinician should determine electrode placement and
stimulation settings.
•Turn off the NESS L300 Plus System before removing, replacing, and
wetting the electrodes.
•Turn 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.
•
Turn off the NESS L300 Plus System before driving, operating machinery,
or performing any activity in which involuntary muscle contractions could
injure you.
•
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.
•Stop using the NESS L300 Plus System and consult your clinician if
stimulation does not start at the correct time during gait.
•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 System stored where temperatures may
exceed the acceptable environmental range: -25°C to +55°C. Temperature
extremes can damage the components.
•The 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.
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8User's Guide
•Do 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 your local distributor 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 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.
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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:
•Signs of significant irritation or pressure sores where the L300 and/or
Thigh 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.
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:
•Clean 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.
•Always check the skin for redness or a rash when putting on and taking
off the L300 and Thigh FS Cuffs.
•Wet the cloth electrodes before use and after every three to four hours
of use.
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10 User's Guide
•Replace the electrodes at least every two weeks, even if they appear to
be in good condition.
•Store the L300 hydrogel electrodes with the protective plastic covers
attached. Do not allow the hydrogel electrodes to dry.
•Store the cloth electrodes where they can air dry.
•
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.
•
When positioning the L300 and Thigh FS Cuffs, make sure the electrodes
uniformly contact the skin.
•Ventilate 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 your local
distributor. 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 your local distributor
or visit the Bioness website at www.bioness.com/Landing.php?reset.
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