Bioness NESS L300 User manual

NESS®, NESS L300™, Intelli-Gait™, Intelli-Sense Gait Sensor™, Bioness®, the Bioness Logo®, LiveOn™ and For function. For freedom. For life.™ are trademarks of
Bioness Inc. | Manufactured by Bioness Neuromodulation Ltd., a Bioness Inc. (USA) Company, 25103 Rye Canyon Loop, Valencia, California 91355 USA | 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.
612-00061-001 Rev. A
Manufactured by Bioness Neuromodulation LTD
a Bioness Inc. Company
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
European 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
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
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NESS L300™
User’s Guide
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User’s Guide
Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law
of the State in which he/she practices to use or order the use of the device.
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II
User Guide Copyright
© 2006, Revised 2008, 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 H200®, Intelli-Gait™, Intelli-Sense Gait Sensor™, Bioness®, the Bioness Logo®,
LiveOn™ and For function. For freedom. For life.™ are trademarks of Bioness Inc. | Manufactured by Bioness
Neuromodulation Ltd., a Bioness Inc. (USA) Company, 25103 Rye Canyon Loop, Valencia, California 91355
USA | 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.’s 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
Details for CE and ETL product safety standards can be found in the List of Symbols on page 75.
3106069
European 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
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
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III
Contents
Introduction to your NESS L30Chapter 1: 0™...................................... 1
Indications For Use.................................................................................. 1
Advanced Technology in Rehabilitation................................................... 1
For Your Health and Safety ..................................................................... 2
General Overview of your NESS L300Chapter 2: ™............................ 9
Components of the NESS L300™............................................................ 9
NESS L300™ FS Cuff and RF Stim Unit................................................. 10
Indicator lights on the RF Stim Unit and Audio Indications ................ 11
The Intelli-Sense Gait Sensor™ .............................................................. 12
The Control Unit ...................................................................................... 13
Control Unit Buttons........................................................................... 14
Control Unit Display and Audio Indications ........................................ 15
Operating ModesChapter 3: ................................................................ 17
Standby mode ......................................................................................... 17
Gait mode................................................................................................ 17
Training mode.......................................................................................... 17
Daily Use of your NESS L300Chapter 4: ™.......................................... 19
Activating and Using the System............................................................. 19
Positioning the FS Cuff on your leg......................................................... 20
Taking the Functional Stimulation (FS) Cuff OFF .................................... 23
Operating the Control Unit....................................................................... 24
Turning ON the system ...................................................................... 24
Selecting the Mode ............................................................................ 24
Adjusting the Stimulation Intensity Level............................................ 25
Adjusting the Volume of the Audio Indication..................................... 25
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IV
Audio Feedback During Stimulation................................................... 26
Safety Features ....................................................................................... 26
Care and MaintenanceChapter 5: ........................................................ 27
Skin Care Guidelines............................................................................... 27
Batteries .................................................................................................. 29
Low Battery Warning.......................................................................... 29
Charging the Batteries ....................................................................... 30
Replacing the Batteries...................................................................... 33
Replacing The Electrodes ....................................................................... 36
Replacing The Electrode Bases .............................................................. 39
Cleaning your NESS L300™................................................................... 40
Replacing and Installing System ComponentsChapter 6: ................ 41
Removing and Installing the RF Stim Unit............................................... 41
Placing an Intelli-Sense Gait Sensor™ in your Shoe .............................. 42
Replacing and Electronically Registering Components........................... 45
Registering a new Control Unit................................................................ 45
Registering a new RF Stim Unit .............................................................. 51
Registering a new Intelli-Sense Gait Sensor™ ....................................... 56
Un-Registering an Intelli-Sense Gait Sensor™ ....................................... 60
AccessoriesChapter 7: ......................................................................... 61
Traveling with your NESS L300™ SystemChapter 8: ........................ 63
TroubleshootingChapter 9: .................................................................. 65
SpecificationsChapter 10: ................................................................... 69
List of SymbolsChapter 11: ................................................................. 75
List of Components and Accessories ...................................................... 76
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V
List of Figures
Figure 1: NESS L300™ Kit ..................................................................... 9
Figure 2: NESS L300™ FS Cuff (Right)................................................ 10
Figure 3: The Intelli-Sense Gait Sensor™ ............................................ 12
Figure 4: The Control Unit..................................................................... 13
Figure 5: Recommended Knee Angle for FS Cuff Application .............. 20
Figure 6: Placing the FS Cuff on the Leg.............................................. 21
Figure 7: Fastening the Strap ............................................................... 22
Figure 8: FS Cuff Fastened in the Correct Position on the Right Leg ....... 23
Figure 9: RF Stim Unit and Control Unit Charging Sockets .................. 30
Figure 10: Connecting the Charger......................................................... 31
Figure 11: Control Unit Charging Indicators............................................ 32
Figure 12: RF Stim Unit Charging Indications......................................... 32
Figure 13: Replacing the Intelli-Sense Gait Sensor™ Battery ................ 34
Figure 14: Replacing the Control Unit’s Battery...................................... 35
Figure 15: Removing Used Electrodes ................................................... 36
Figure 16a: Tearing apart the electrodes.................................................. 37
Figure 16b: Peeling off the 2-piece split covers........................................ 37
Figure 17: Attaching the grid side of the electrode to a base ................. 37
Figure 18: Removing the electrode liners from the electrodes ............... 38
Figure 19: Attaching the Electrode liner.................................................. 39
Figure 20: Removing the RF Stim Unit from the FS Cuff........................ 41
Figure 21: Intelli-Sense Gait Sensor™ Adhesive Loop Pad Position in a Shoe .. 42
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VI
Figure 22: Intelli-Sense Gait Sensor™ in Place Under Insole ................ 43
Figure 23: Transmitter in Place (Left Shoe Shown) ................................ 44
Figure 24: Shoe Spacer .......................................................................... 44
Figure 25: Optimal Component Arrangement ......................................... 46
Figure 26: Registration Process.............................................................. 47
Figure 27: Digital Displays while Registering.......................................... 48
Figure 28: Blank sticker on the back of the Control Unit......................... 49
Figure 29: Blank sticker on the back of the RF Stim Unit........................ 51
Figure 30: Registration Process.............................................................. 53
Figure 31: Digital Displays while Registering.......................................... 54
Figure 32: Optimal Component Arrangement ......................................... 56
Figure 33: Registration Process.............................................................. 57
Figure 34: Digital Displays while Registering.......................................... 58
Figure 35: Blank sticker on the back of the Gait Sensor......................... 59
Figure 36: Accessories ........................................................................... 61
List of Tables
Table 1: RF Stim Unit Indications .........................................................11
Table 2: Control Unit Buttons............................................................... 14
Table 3: Control Unit Display Indications ............................................. 15
Table 4: Error Indications..................................................................... 16
Table 5: Low Battery Warning Indications ........................................... 29
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1
Chapter 1 - Introduction
Introduction to your NESS L300™
Indications For Use
The NESS L300™ is intended to provide ankle dorsiflexion in individuals with
foot drop 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 the swing phase of gait, the NESS L300™ electrically
stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus,
it may improve the individual’s gait. The NESS L300™ may also facilitate
muscle re-education, prevent/retard disuse atrophy, maintain or increase
joint range of motion and increase local blood flow.
Advanced Technology in Rehabilitation
Central nervous system injuries often cause a gait disorder called “Foot Drop”
which is the inability to raise the foot while walking and therefore results in
dragging of the foot, instability and increased effort during gait.
The NESS L300™ is an advanced neuroprosthesis designed to improve gait
in people suffering from foot drop as a result of a central nervous system
injury or diseases such as stroke, traumatic brain injury, multiple sclerosis,
cerebral palsy or incomplete spinal cord injuries.
The NESS L300™ System consists of a Functional Stimulation (FS) Cuff,
Intelli-Sense Gait Sensor™ and Control Unit. These components communicate
wirelessly, thus enabling easy and comfortable use without cumbersome wires.
The NESS L300™ delivers electrical pulses to the Peroneal Nerve which
controls the movement of the lower leg muscles, causing them to raise the
foot at the appropriate phase of walking and therefore prevents foot drop.
The FS Cuff can be used single handedly and its advanced ergonomic design
1
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2User’s Guide
ensures constant and snug contact between the user’s limb and its integrated
Electrodes. While walking, the Intelli-Sense Gait Sensor™ detects whether
the foot is in the air or on the ground and transmits that information to the
rest of the system which accordingly activates the foot.
The wireless Control Unit displays information regarding the system’s status
and manages the various system components.
The NESS L300™ System incorporates cutting edge technology and
sophisticated design features in order to improve your walking and quality
of life.
Please read this guide carefully in order to maximize the benefits provided
by this advanced system.
For Your Health and Safety
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 on the leg if a cancerous lesion•
is present or suspected.
The NESS L300™ should not be used over areas of regional disorders,•
such as a fracture or dislocation, which would be adversely affected by
motion from the stimulation.
Warnings
The long-term effects of chronic electrical stimulation are unknown.•
The Functional Stimulation (FS) Cuff should not be applied over•
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3
Chapter 1 - Introduction
swollen, infected, or inflamed areas or skin eruptions, such as phlebitis,
thrombophlebitis, varicose veins, and so on.
Simultaneous connection of the NESS L300™ to the patient and to high- •
frequency surgical equipment may result in burns at the site of the stimulator
Electrodes and possible damage to the RF Stim Unit of the FS Cuff.
Do not use the NESS L300™ in close proximity (less than three feet) to•
short wave or microwave therapy equipment as it may produce instability
in the RF Stim Unit output.
System configuration should only be performed by an authorized•
clinician.
Precautions
Inflammation in the region of the NESS L300™ may be aggravated by motion, •
muscle activity, or pressure from the FS Cuff. Use of the device should
be temporarily halted until the inflammation is resolved completely.
Caution should be used in patients with suspected or diagnosed heart•
problems.
Caution should be used in the presence of the following conditions in the •
area of the Functional Stimulation (FS) Cuff:
When there is 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.•
For patients with suspected or diagnosed epilepsy.•
Some patients may experience skin irritation, an allergic reaction or•
hypersensitivity due to the electrical stimulation or the electrical conductive
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4User’s Guide
medium. In some cases irritation may be avoided by changing the stimulation
parameters or altering the electrode placement (performed by the treating
clinician).
Do not use the NESS L300™ without electrodes.•
After removing the Functional Stimulation (FS) Cuff it is normal for the•
areas under the electrodes to be red and indented; however, the redness
should disappear in approximately one hour. Persistent redness, lesions
or blisters are signs of irritation. Use of the device should be temporarily
halted until the inflammation is resolved completely.
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™ System during x-ray examinations.•
Turn the NESS L300™ off when refueling; don’t use the NESS L300™ at •
a refueling point. Don’t use near inflammable fuel, fumes or chemicals.
Electrode placement and stimulation settings should be determined by•
the treating clinician.
The NESS L300™ should be used only with Electrodes supplied by•
Bioness Inc.
Specific physician clearance should be obtained prior to use in patients•
with alteration of normal arterial or venous flow in the region of the FS
Cuff due to local insufficiency, occlusion, arterio-venous fistula for the
purpose of hemodialysis, or a primary disorder of the vasculature.
Specific physician clearance should be obtained when there is a structural •
deformity in the area to be stimulated.
The safety of the NESS L300™’s use during pregnancy has not been•
established.
Skin problems in areas of contact with the FS Cuff may be aggravated•
by use of the NESS L300™.
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5
Chapter 1 - Introduction
The NESS L300™ should be turned off before removing or replacing the•
Electrodes.
The NESS L300™ should be kept out of the reach of children.•
The NESS L300™ Control Unit is splash proof. However, it should be•
protected from any contact with water, such as water from sinks, bathtubs,
and shower stalls, from weather such as rain or snow, or any other source
of water.
Do not leave the NESS L300™ stored in a car in hot or cold weather where •
the temperature may exceed the recommended storage temperatures of
-20 to 60°C (-4 to 140°F) and could cause damage to the device.
Should any technical problem occur that is not covered in the Troubleshooting •
section of this manual, contact Bioness Inc. Do not attempt to repair the
NESS L300™.
The FS Cuff is meant to be worn only on the leg of the patient for whom•
it is fitted. It should not be applied to anyone else or any other part of
the body.
Put on the FS Cuff only when the NESS L300™ is turned off. Do not•
activate it until it is fastened in place.
The System should be shut off while driving, operating machinery, or•
during any activity in which involuntary muscle contractions may put the
patient at undue risk of injury.
In order to avoid condensation problems, when moving the NESS L300™ •
between hot and cold temperatures, place the NESS L300™ in an airtight
plastic bag and let it slowly adjust to the temperature changes (at least
2 hours) before using the System.
Medical electrical equipment needs special precautions regarding•
Electromagnetic Compatibility (EMC) and needs to be installed and put
into service.
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6User’s Guide
Adverse Reactions
In the unlikely event of any of the following occurrences, the patient should
stop using the NESS L300™ immediately and consult his/her personal
physician:
Signs of significant skin irritation or pressure sores on the limb in areas•
of contact with the Functional Stimulation (FS) Cuff.
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.
Home users of the NESS L300™ should not don or operate
the system prior to being properly fit and trained by a certified
clinician.
Radio Communication Information
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 (Radio Frequency 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 radio frequency
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,
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7
Chapter 1 - Introduction
which can be determined by turning the equipment off and on, the patient 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.
Changes or modifications to this equipment not expressly
approved by Bioness Inc. could void the user’s authority to
operate the equipment.
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8User’s Guide
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9
Chapter 2 - General Overview of your NESS L300™
General Overview of your NESS L300™
Components of the NESS L300™
The NESS L300™ is available with a right or left Functional Stimulation (FS)
Cuff. The kit is supplied with the following components:
Control Unit and optional neck strap, wrist strap, or belt pouch•
Left or Right FS Cuff & RF Stim Unit•
FS Cuff Strap, your clinician will specify small, medium or large size•
Intelli-Sense Gait Sensor™ & adhesive loop pads•
Electrodes & Electrode Bases•
Charger•
Shoe Spacers•
User’s Guide•
User Instruction Card•
Carrying case•
Control UnitElectrodes
Charger User's Guide
FS Cuff
Figure 1: NESS L300™ Kit
Intelli-Sense Gait Sensor™
2
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10 User’s Guide
NESS L300™ FS Cuff and RF Stim Unit
Figure 2: NESS L300™ FS Cuff (Right)
The FS Cuff is light weight and has a low profile allowing it to be positioned •
under clothing.
It is anatomically designed to allow accurate placement on the leg.•
The RF Stim Unit is integrated into the cradle on the FS Cuff. It may•
be snapped in or out of the FS Cuff for maintenance or to wash the FS
Cuff.
The device is held in place by a strap which may be fastened using only•
one hand.
Two Electrodes are attached to Electrode Bases on the inner lining of the •
FS Cuff; their position in the FS Cuff has been carefully determined by the
clinician during the fitting process. The Electrodes can be easily replaced
by the user without changing the position of the Electrode Bases.
Electrode Base
Electrode
Locator
Strap
Handle
Cradle
Status Light
Stimulation Light
RF Stim Unit
Strap
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11
Chapter 2 - General Overview of your NESS L300™
Indicator lights on the RF Stim Unit and Audio Indications
Indicator lights on the RF Stim Unit displays the unit’s status and when
stimulation occurs.
RF Stim Unit Display Display Pattern Description
Status Light
Flashes Green System is ON
Flashes Yellow Low Battery
Alternating between
Yellow and Green Charging
Constant Green Fully Charged
Flashes Red Radio Communication
Failure
Constant Red RF Stim Unit
Malfunction
Stimulation
Light Flashes Yellow
SLOWLY Stimulation Inactive
Flashes Yellow
RAPIDLY Stimulation Applied
Table 1: RF Stim Unit Indications
An audio alert will be emitted from the RF Stim Unit if
communication fails or a malfunction occurs.
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12 User’s Guide
The Intelli-Sense Gait Sensor™
The Intelli-Sense Gait Sensor™ (Figure 3) detects whether the foot is on the
ground or in the air and transmits the event status to the RF Stim Unit via
radio signals.
The Intelli-Sense Gait Sensor™ consists of a pressure sensor worn underneath
the insole of the shoe and a small transmitter attached to the upper edge of
the shoe by a clamp.
There is no need to detach the Intelli-Sense Gait Sensor™ between uses.
The Intelli-Sense Gait Sensor™ is powered by a small non-rechargeable
battery which needs replacing after approximately six months of use.
The Intelli-Sense Gait Sensor™ should be placed under the paretic (weak)
foot.
A single Intelli-Sense Gait Sensor™ is provided with the NESS L300™ System.
Additional Intelli-Sense Gait Sensor™s can be purchased separately to avoid
having to transfer the Intelli-Sense Gait Sensor™ from one shoe to another
when wearing different pairs of shoes.
Figure 3: The Intelli-Sense Gait Sensor™
Transmitter
Pressure
Sensor
Shoe Insole
Adhesive Loop Pad
Clamp
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